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30.4.2021 EN Official Journal of the European Union L 149/10 TRADE AND COOPERATION Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part PREAMBLE THE EUROPEAN UNION AND THE EUROPEAN ATOMIC ENERGY COMMUNITY AND THE UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND, 1. REAFFIRMING their commitment to democratic principles, to the rule of law, to human rights, to countering proliferation of weapons of mass destruction and to the fight against climate change, which constitute essential elements of this and supplementing agreements, 2. RECOGNISING the importance of global cooperation to address issues of shared interest, 3. RECOGNISING the importance of transparency in international trade and investment to the benefit of all stakeholders, 4. SEEKING to establish clear and mutually advantageous rules governing trade and investment between the Parties, 5. CONSIDERING that in order to guarantee the efficient management and correct interpretation and application of this Agreement and any supplementing agreement, as well as compliance with the obligations under those agreements, it is essential to establish provisions ensuring overall governance, in particular dispute settlement and enforcement rules that fully respect the autonomy of the respective legal orders of the Union and of the United Kingdom, as well as the United Kingdom's status as a country outside the European Union, 6. BUILDING upon their respective rights and obligations under the Marrakesh Agreement Establishing the World Trade Organization, done on 15 April 1994, and other multilateral and bilateral instruments of cooperation, 7. RECOGNISING the Parties' respective autonomy and rights to regulate within their territories in order to achieve legitimate public policy objectives such as the protection and promotion of public health, social services, public education, safety, the environment including climate change, public morals, social or consumer protection, animal welfare, privacy and data protection and the promotion and protection of cultural diversity, while striving to improve their respective high levels of protection, 8. BELIEVING in the benefits of a predictable commercial environment that fosters trade and investment between the Parties and prevents the distortion of trade and unfair competitive advantages, in a manner conducive to sustainable development in its economic, social and environmental dimensions, 9. RECOGNISING the need for an ambitious, wide-ranging and balanced economic partnership to be underpinned by a level playing field for open and fair competition and sustainable development, through effective and robust frameworks for subsidies and competition and a commitment to uphold their respective high levels of protection in the areas of labour and social standards, environment, the fight against climate change, and taxation, 10. RECOGNISING the need to ensure an open and secure market for businesses, including small and medium-sized enterprises, and their goods and services through addressing unjustified barriers to trade and investment, 11. NOTING the importance of facilitating new opportunities for businesses and consumers through digital trade, and addressing unjustified barriers to data flows and trade enabled by electronic means, whilst respecting the Parties' personal data protection rules, 12. DESIRING that this Agreement contribute to consumer welfare through policies ensuring a high level of consumer protection and economic well-being, as well as encouraging cooperation between relevant authorities, 13. CONSIDERING the importance of cross-border connectivity by air, by road and by sea, for passengers and for goods, and the need to ensure high standards in the provision of transportation services between the Parties, 14. RECOGNISING the benefits of trade and investment in energy and raw materials and the importance of supporting the delivery of cost efficient, clean and secure energy supplies to the Union and the United Kingdom, 15. NOTING the interest of the Parties in establishing a framework to facilitate technical cooperation and to develop new trading arrangements for interconnectors which deliver robust and efficient outcomes for all timeframes, 16. NOTING that cooperation and trade between the Parties in these areas should be based on fair competition in energy markets and non-discriminatory access to networks, 17. RECOGNISING the benefits of sustainable energy, renewable energy, in particular offshore generation in the North Sea, and energy efficiency, 18. DESIRING to promote the peaceful use of the waters adjacent to their coasts and the optimum and equitable utilisation of the marine living resources in those waters including the continued sustainable management of shared stocks, 19. NOTING that the United Kingdom withdrew from the European Union and that with effect from 1 January 2021, the United Kingdom is an independent coastal State with corresponding rights and obligations under international law, 20. AFFIRMING that the sovereign rights of the coastal States exercised by the Parties for the purpose of exploring, exploiting, conserving and managing the living resources in their waters should be conducted pursuant to and in accordance with the principles of international law, including the United Nations Convention on the Law of the Sea, done at Montego Bay on 10 December 1982 (United Nations Convention on the Law of the Sea), 21. RECOGNISING the importance of the coordination of social security rights enjoyed by persons moving between the Parties to work, to stay or to reside, as well as the rights enjoyed by their family members and survivors, 22. CONSIDERING that cooperation in areas of shared interest, such as science, research and innovation, nuclear research and space, in the form of the participation of the United Kingdom in the corresponding Union programmes under fair and appropriate conditions will benefit both Parties, 23. CONSIDERING that cooperation between the United Kingdom and the Union relating to the prevention, investigation, detection or prosecution of criminal offences and to the execution of criminal penalties, including the safeguarding against and prevention of threats to public security, will enable the security of the United Kingdom and the Union to be strengthened, 24. DESIRING that an agreement is concluded between the United Kingdom and the Union to provide a legal base for such cooperation, 25. ACKNOWLEDGING that the Parties may supplement this Agreement with other agreements forming an integral part of their overall bilateral relations as governed by this Agreement and that the Agreement on Security Procedures for Exchanging and Protecting Classified Information is concluded as such a supplementing agreement and enables the exchange of classified information between the Parties under this Agreement or any other supplementing agreement, HAVE AGREED AS FOLLOWS: PART ONE COMMON AND INSTITUTIONAL PROVISIONS TITLE I GENERAL PROVISIONS Article 1 Purpose This Agreement establishes the basis for a broad relationship between the Parties, within an area of prosperity and good neighbourliness characterised by close and peaceful relations based on cooperation, respectful of the Parties' autonomy and sovereignty. Article 2 Supplementing agreements 1. Where the Union and the United Kingdom conclude other bilateral agreements between them, such agreements shall constitute supplementing agreements to this Agreement, unless otherwise provided for in those agreements. Such supplementing agreements shall be an integral part of the overall bilateral relations as governed by this Agreement and shall form part of the overall framework. 2. Paragraph 1 also applies to: (a) agreements between the Union and its Member States, of the one part, and the United Kingdom, of the other part; and (b) agreements between the European Atomic Energy Community, of the one part, and the United Kingdom, of the other part. Article 3 Good faith 1. The Parties shall, in full mutual respect and good faith, assist each other in carrying out tasks that flow from this Agreement and any supplementing agreement. 2. They shall take all appropriate measures, whether general or particular, to ensure the fulfilment of the obligations arising from this Agreement and from any supplementing agreement, and shall refrain from any measures which could jeopardise the attainment of the objectives of this Agreement or any supplementing agreement. TITLE II PRINCIPLES OF INTERPRETATION AND DEFINITIONS Article 4 Public international law 1. The provisions of this Agreement and any supplementing agreement shall be interpreted in good faith in accordance with their ordinary meaning in their context and in light of the object and purpose of the agreement in accordance with customary rules of interpretation of public international law, including those codified in the Vienna Convention on the Law of Treaties, done at Vienna on 23 May 1969. 2. For greater certainty, neither this Agreement nor any supplementing agreement establishes an obligation to interpret their provisions in accordance with the domestic law of either Party. 3. For greater certainty, an interpretation of this Agreement or any supplementing agreement given by the courts of either Party shall not be binding on the courts of the other Party. Article 5 Private rights 1. Without prejudice to Article SSC.67 of the Protocol on Social Security Coordination and with the exception, with regard to the Union, of Part Three of this Agreement, nothing in this Agreement or any supplementing agreement shall be construed as conferring rights or imposing obligations on persons other than those created between the Parties under public international law, nor as permitting this Agreement or any supplementing agreement to be directly invoked in the domestic legal systems of the Parties. 2. A Party shall not provide for a right of action under its law against the other Party on the ground that the other Party has acted in breach of this Agreement or any supplementing agreement. Article 6 Definitions 1. For the purposes of this Agreement and any supplementing agreement, and unless otherwise specified, the following definitions apply: (a) "data subject" means an identified or identifiable natural person; an identifiable person being a person who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data or an online identifier, or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person; (b) "day" means a calendar day; (c) "Member State" means a Member State of the European Union; (d) "personal data" means any information relating to a data subject; (e) "State" means a Member State or the United Kingdom, as the context requires; (f) "territory" of a Party means in respect of each Party the territories to which this Agreement applies in accordance with Article 774; (g) "the transition period" means the transition period provided for in Article 126 of the Withdrawal Agreement; and (h) "Withdrawal Agreement" means the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, including its Protocols. 2. Any reference to the "Union", "Party" or "Parties" in this Agreement or any supplementing agreement shall be understood as not including the European Atomic Energy Community, unless otherwise specified or where the context otherwise requires. TITLE III INSTITUTIONAL FRAMEWORK Article 7 Partnership Council 1. A Partnership Council is hereby established. It shall comprise representatives of the Union and of the United Kingdom. The Partnership Council may meet in different configurations depending on the matters under discussion. 2. The Partnership Council shall be co-chaired by a Member of the European Commission and a representative of the Government of the United Kingdom at ministerial level. It shall meet at the request of the Union or the United Kingdom, and, in any event, at least once a year, and shall set its meeting schedule and its agenda by mutual consent. 3. The Partnership Council shall oversee the attainment of the objectives of this Agreement and any supplementing agreement. It shall supervise and facilitate the implementation and application of this Agreement and of any supplementing agreement. Each Party may refer to the Partnership Council any issue relating to the implementation, application and interpretation of this Agreement or of any supplementing agreement. 4. The Partnership Council shall have the power to: (a) adopt decisions in respect of all matters where this Agreement or any supplementing agreement so provides; (b) make recommendations to the Parties regarding the implementation and application of this Agreement or of any supplementing agreement; (c) adopt, by decision, amendments to this Agreement or to any supplementing agreement in the cases provided for in this Agreement or in any supplementing agreement; (d) except in relation to Title III of Part One, until the end of the fourth year following the entry into force of this Agreement, adopt decisions amending this Agreement or any supplementing agreement, provided that such amendments are necessary to correct errors, or to address omissions or other deficiencies; (e) discuss any matter related to the areas covered by this Agreement or by any supplementing agreement; (f) delegate certain of its powers to the Trade Partnership Committee or to a Specialised Committee, except those powers and responsibilities referred to in point (g) of this paragraph; (g) by decision, establish Trade Specialised Committees and Specialised Committees, other than those referred to in Article 8(1), dissolve any Trade Specialised Committee or Specialised Committee, or change the tasks assigned to them; and (h) make recommendations to the Parties regarding the transfer of personal data in specific areas covered by this Agreement or any supplementing agreement. 5. The work of the Partnership Council shall be governed by the rules of procedure set out in Annex 1. The Partnership Council may amend that Annex. Article 8 Committees 1. The following Committees are hereby established: (a) the Trade Partnership Committee, which addresses matters covered by Titles I to VII, Chapter 4 of Title VIII, Titles IX to XII of Heading One of Part Two, Heading Six of Part Two, and Annex 27; (b) the Trade Specialised Committee on Goods which addresses matters covered by Chapter 1 of Title I of Heading One of Part Two and Chapter 4 of Title VIII of Heading One of Part Two; (c) the Trade Specialised Committee on Customs Cooperation and Rules of Origin, which addresses matters covered by Chapters 2 and 5 of Title I of Heading One of Part Two, the Protocol on mutual administrative assistance in customs matters and the provisions on customs enforcement of intellectual property rights, fees and charges, customs valuation and repaired goods; (d) the Trade Specialised Committee on Sanitary and Phytosanitary Measures, which addresses matters covered by Chapter 3 of Title I of Heading One of Part Two; (e) the Trade Specialised Committee on Technical Barriers to Trade, which addresses matters covered by Chapter 4 of Title I of Heading One of Part Two and Article 323; (f) the Trade Specialised Committee on Services, Investment and Digital Trade, which addresses matters covered by Titles II to IV of Heading One of Part Two and Chapter 4 of Title VIII of Heading One of Part Two; (g) the Trade Specialised Committee on Intellectual Property, which addresses matters covered by Title V of Heading One of Part Two; (h) the Trade Specialised Committee on Public Procurement, which addresses matters covered by Title VI of Heading One of Part Two; (i) the Trade Specialised Committee on Regulatory Cooperation, which addresses matters covered by Title X of Heading One of Part Two; (j) the Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development, which addresses matters covered by Title XI of Heading One of Part Two and Annex 27; (k) the Trade Specialised Committee on Administrative Cooperation in VAT and Recovery of Taxes and Duties, which addresses matters covered by the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties; (l) the Specialised Committee on Energy, (i) which addresses matters covered by Title VIII of Heading One of Part Two, with the exception of Chapter 4, Article 323 and Annex 27, and (ii) which can discuss and provide expertise to the relevant Trade Specialised Committee on matters pertaining to Chapter 4 and Article 323; (m) the Specialised Committee on Air Transport, which addresses matters covered by Title I of Heading Two of Part Two; (n) the Specialised Committee on Aviation Safety, which addresses matters covered by Title II of Heading Two of Part Two; (o) the Specialised Committee on Road Transport, which addresses matters covered by Heading Three of Part Two; (p) the Specialised Committee on Social Security Coordination, which addresses matters covered by Heading Four of Part Two and the Protocol on Social Security Coordination; (q) the Specialised Committee on Fisheries, which addresses matters covered by Heading Five of Part Two; (r) the Specialised Committee on Law Enforcement and Judicial Cooperation, which addresses matters covered by Part Three; and (s) the Specialised Committee on Participation in Union Programmes, which addresses matters covered by Part Five. 2. With respect to issues related to Titles I to VII, Chapter 4 of Title VIII, Titles IX to XII of Heading One of Part Two, Heading Six of Part Two and Annex 27, the Trade Partnership Committee referred to in paragraph 1 of this Article shall have the power to: (a) assist the Partnership Council in the performance of its tasks and, in particular, report to the Partnership Council and carry out any task assigned to it by the latter; (b) supervise the implementation of this Agreement or any supplementing agreement; (c) adopt decisions or make recommendations as provided for in this Agreement or any supplementing agreement or where such power has been delegated to it by the Partnership Council; (d) supervise the work of the Trade Specialised Committees referred to in paragraph 1 of this Article; (e) explore the most appropriate way to prevent or solve any difficulty that may arise in relation to the interpretation and application of this Agreement or any supplementing agreement, without prejudice to Title I of Part Six; (f) exercise the powers delegated to it by the Partnership Council pursuant to point (f) of Article 7(4); (g) establish, by decision, Trade Specialised Committees other than those referred to in paragraph 1 of this Article, dissolve any such Trade Specialised Committee, or change the tasks assigned to them; and (h) establish, supervise, coordinate and dissolve Working Groups, or delegate their supervision to a Trade Specialised Committee. 3. With respect to issues related to their area of competence, Trade Specialised Committees shall have the power to: (a) monitor and review the implementation and ensure the proper functioning of this Agreement or any supplementing agreement; (b) assist the Trade Partnership Committee in the performance of its tasks and, in particular, report to the Trade Partnership Committee and carry out any task assigned to them by it; (c) conduct the preparatory technical work necessary to support the functions of the Partnership Council and the Trade Partnership Committee, including when those bodies have to adopt decisions or recommendations; (d) adopt decisions in respect of all matters where this Agreement or any supplementing agreement so provides; (e) discuss technical issues arising from the implementation of this Agreement or of any supplementing agreement, without prejudice to Title I of Part Six; and (f) provide a forum for the Parties to exchange information, discuss best practices and share implementation experience. 4. With respect to issues related to their area of competence, Specialised Committees shall have the power to: (a) monitor and review the implementation and ensure the proper functioning of this Agreement or any supplementing agreement; (b) assist the Partnership Council in the performance of its tasks and, in particular, report to the Partnership Council and carry out any task assigned to them by it; (c) adopt decisions, including amendments, and recommendations in respect of all matters where this Agreement or any supplementing agreement so provides or for which the Partnership Council has delegated its powers to a Specialised Committee in accordance with point (f) of Article 7(4); (d) discuss technical issues arising from the implementation of this Agreement or any supplementing agreement; (e) provide a forum for the Parties to exchange information, discuss best practices and share implementation experience; (f) establish, supervise, coordinate and dissolve Working Groups; and (g) provide a forum for consultation pursuant to Article 738(7). 5. Committees shall comprise representatives of each Party. Each Party shall ensure that its representatives on the Committees have the appropriate expertise with respect to the issues under discussion. 6. The Trade Partnership Committee shall be co-chaired by a senior representative of the Union and a representative of the United Kingdom with responsibility for trade-related matters, or their designees. It shall meet at the request of the Union or the United Kingdom, and, in any event, at least once a year, and shall set its meeting schedule and its agenda by mutual consent. 7. The Trade Specialised Committees and the Specialised Committees shall be co-chaired by a representative of the Union and a representative of the United Kingdom. Unless otherwise provided for in this Agreement, or unless the co-chairs decide otherwise, they shall meet at least once a year. 8. Committees shall set their meeting schedule and agenda by mutual consent. 9. The work of the Committees shall be governed by the rules of procedure set out in Annex 1. 10. By way of derogation from paragraph 9, a Committee may adopt and subsequently amend its own rules that shall govern its work. Article 9 Working Groups 1. The following Working Groups are hereby established: (a) the Working Group on Organic Products, under the supervision of the Trade Specialised Committee on Technical Barriers to Trade; (b) the Working Group on Motor Vehicles and Parts, under the supervision of the Trade Specialised Committee on Technical Barriers to Trade; (c) the Working Group on Medicinal Products, under the supervision of the Trade Specialised Committee on Technical Barriers to Trade; (d) the Working Group on Social Security Coordination, under the supervision of the Specialised Committee on Social Security Coordination. 2. Working Groups shall, under the supervision of Committees, assist Committees in the performance of their tasks and, in particular, prepare the work of Committees and carry out any task assigned to them by the latter. 3. Working Groups shall comprise representatives of the Union and of the United Kingdom and shall be co-chaired by a representative of the Union and a representative of the United Kingdom. 4. Working Groups shall set their own rules of procedure, meeting schedule and agenda by mutual consent. Article 10 Decisions and recommendations 1. The decisions adopted by the Partnership Council, or, as the case may be, by a Committee, shall be binding on the Parties and on all the bodies set up under this Agreement and under any supplementing agreement, including the arbitration tribunal referred to in Title I of Part Six. Recommendations shall have no binding force. 2. The Partnership Council or, as the case may be, a Committee, shall adopt decisions and make recommendations by mutual consent. Article 11 Parliamentary cooperation 1. The European Parliament and the Parliament of the United Kingdom may establish a Parliamentary Partnership Assembly consisting of Members of the European Parliament and of Members of the Parliament of the United Kingdom, as a forum to exchange views on the partnership. 2. Upon its establishment, the Parliamentary Partnership Assembly: (a) may request relevant information regarding the implementation of this Agreement and any supplementing agreement from the Partnership Council, which shall then supply that Assembly with the requested information; (b) shall be informed of the decisions and recommendations of the Partnership Council; and (c) may make recommendations to the Partnership Council. Article 12 Participation of civil society The Parties shall consult civil society on the implementation of this Agreement and any supplementing agreement, in particular through interaction with the domestic advisory groups and the Civil Society Forum referred to in Articles 13 and 14. Article 13 Domestic advisory groups 1. Each Party shall consult on issues covered by this Agreement and any supplementing agreement its newly created or existing domestic advisory group or groups comprising a representation of independent civil society organisations including non-governmental organisations, business and employers' organisations, as well as trade unions, active in economic, sustainable development, social, human rights, environmental and other matters. Each Party may convene its domestic advisory group or groups in different configurations to discuss the implementation of different provisions of this Agreement or of any supplementing agreement. 2. Each Party shall consider views or recommendations submitted by its domestic advisory group or groups. Representatives of each Party shall aim to consult with their respective domestic advisory group or groups at least once a year. Meetings may be held by virtual means. 3. In order to promote public awareness of the domestic advisory groups, each Party shall endeavour to publish the list of organisations participating in its domestic advisory group or groups as well as the contact point for that or those groups. 4. The Parties shall promote interaction between their respective domestic advisory groups, including by exchanging where possible the contact details of members of their domestic advisory groups. Article 14 Civil Society Forum 1. The Parties shall facilitate the organisation of a Civil Society Forum to conduct a dialogue on the implementation of Part Two. The Partnership Council shall adopt operational guidelines for the conduct of the Forum. 2. The Civil Society Forum shall meet at least once a year, unless otherwise agreed by the Parties. The Civil Society Forum may meet by virtual means. 3. The Civil Society Forum shall be open for the participation of independent civil society organisations established in the territories of the Parties, including members of the domestic advisory groups referred to in Article 13. Each Party shall promote a balanced representation, including non-governmental organisations, business and employers' organisations and trade unions, active in economic, sustainable development, social, human rights, environmental and other matters. PART TWO TRADE, TRANSPORT, FISHERIES AND OTHER ARRANGEMENTS HEADING ONE TRADE TITLE I TRADE IN GOODS CHAPTER 1 NATIONAL TREATMENT AND MARKET ACCESS FOR GOODS (INCLUDING TRADE REMEDIES) Article 15 Objective The objective of this Chapter is to facilitate trade in goods between the Parties and to maintain liberalised trade in goods in accordance with the provisions of this Agreement. Article 16 Scope Except as otherwise provided, this Chapter applies to trade in goods of a Party. Article 17 Definitions For the purposes of this Chapter, the following definitions apply: (a) "consular transactions" means the procedure of obtaining from a consul of the importing Party in the territory of the exporting Party, or in the territory of a third party, a consular invoice or a consular visa for a commercial invoice, certificate of origin, manifest, shipper's export declaration or any other customs documentation in connection with the importation of the good; (b) "Customs Valuation Agreement" means the Agreement on Implementation of Article VII of GATT 1994; (c) "export licensing procedure" means an administrative procedure, whether or not referred to as licensing, used by a Party for the operation of export licensing regimes, requiring the submission of an application or other documentation, other than that generally required for customs clearance purposes, to the relevant administrative body as a prior condition for exportation from that Party; (d) "import licensing procedure" means an administrative procedure, whether or not referred to as licensing, used by a Party for the operation of import licensing regimes, requiring the submission of an application or other documentation, other than that generally required for customs clearance purposes, to the relevant administrative body or bodies as a prior condition for importation into the territory of the importing Party; (e) "originating goods" means, unless otherwise provided, a good qualifying under the rules of origin set out in Chapter 2 of this Title; (f) "performance requirement" means a requirement that: (i) a given quantity, value or percentage of goods be exported; (ii) goods of the Party granting an import licence be substituted for imported goods; (iii) a person benefiting from an import licence purchase other goods in the territory of the Party granting the import licence, or accord a preference to domestically produced goods; (iv) a person benefiting from an import licence produce goods in the territory of the Party granting the import licence, with a given quantity, value or percentage of domestic content; or (v) relates in whatever form to the volume or value of imports, to the volume or value of exports or to the amount of foreign exchange flows; (g) "remanufactured good" means a good classified under HS Chapters 32, 40, 84 to 90, 94 or 95 that: (i) is entirely or partially composed of parts obtained from used goods; (ii) has similar life expectancy and performance compared with such goods, when new; and (iii) is given an equivalent warranty to as that applicable to such goods when new; and (h) "repair" means any processing operation undertaken on a good to remedy operating defects or material damage and entailing the re-establishment of the good to its original function or to ensure compliance with technical requirements for its use. Repair of a good includes restoration and maintenance, with a possible increase in the value of the good from restoring the original functionality of that good, but does not include an operation or process that: (i) destroys the essential characteristics of a good, or creates a new or commercially different good; (ii) transforms an unfinished good into a finished good; or (iii) is used to improve or upgrade the technical performance of a good. Article 18 Classification of goods The classification of goods in trade between the Parties under this Agreement is set out in each Party's respective tariff nomenclature in conformity with the Harmonised System. Article 19 National treatment on internal taxation and regulation Each Party shall accord national treatment to the goods of the other Party in accordance with Article III of GATT 1994 including its Notes and Supplementary Provisions. To that end, Article III of GATT 1994 and its Notes and Supplementary Provisions are incorporated into and made part of this Agreement, mutatis mutandis. Article 20 Freedom of transit Each Party shall accord freedom of transit through its territory, via the routes most convenient for international transit, for traffic in transit to or from the territory of the other Party or of any other third country. To that end, Article V of GATT 1994 and its Notes and Supplementary Provisions are incorporated into and made part of this Agreement, mutatis mutandis. The Parties understand that Article V of GATT 1994 includes the movement of energy goods via inter alia pipelines or electricity grids. Article 21 Prohibition of customs duties Except as otherwise provided for in this Agreement, customs duties on all goods originating in the other Party shall be prohibited. Article 22 Export duties, taxes or other charges 1. A Party may not adopt or maintain any duty, tax or other charge of any kind imposed on, or in connection with, the exportation of a good to the other Party; or any internal tax or other charge on a good exported to the other Party that is in excess of the tax or charge that would be imposed on like goods when destined for domestic consumption. 2. For the purpose of this Article the term "other charge of any kind" does not include fees or other charges that are permitted under Article 23. Article 23 Fees and formalities 1. Fees and other charges imposed by a Party on or in connection with importation or exportation of a good of the other Party shall be limited in amount to the approximate cost of the services rendered, and shall not represent an indirect protection to domestic goods or taxation of imports or exports for fiscal purposes. A Party shall not levy fees or other charges on or in connection with importation or exportation on an ad valorem basis. 2. Each Party may impose charges or recover costs only where specific services are rendered, in particular, but not limited to, the following: (a) attendance, where requested, by customs staff outside official office hours or at premises other than customs premises; (b) analyses or expert reports on goods and postal fees for the return of goods to an applicant, particularly in respect of decisions relating to binding information or the provision of information concerning the application of the customs laws and regulations; (c) the examination or sampling of goods for verification purposes, or the destruction of goods, where costs other than the cost of using customs staff are involved; and (d) exceptional control measures, if these are necessary due to the nature of the goods or to a potential risk. 3. Each Party shall promptly publish all fees and charges it imposes in connection with importation or exportation via an official website in such a manner as to enable governments, traders and other interested parties, to become acquainted with them. That information shall include the reason for the fee or charge for the service provided, the responsible authority, the fees and charges that will be applied, and when and how payment is to be made. New or amended fees and charges shall not be imposed until information in accordance with this paragraph has been published and made readily available. 4. A Party shall not require consular transactions, including related fees and charges, in connection with the importation of any good of the other Party. Article 24 Repaired goods 1. A Party shall not apply a customs duty to a good, regardless of its origin, that re-enters the Party's territory after that good has been temporarily exported from its territory to the territory of the other Party for repair. 2. Paragraph 1 does not apply to a good imported in bond, into free trade zones, or in similar status, that is then exported for repair and is not re-imported in bond, into free trade zones, or in similar status. 3. A Party shall not apply a customs duty to a good, regardless of its origin, imported temporarily from the territory of the other Party for repair. Article 25 Remanufactured goods 1. A Party shall not accord to remanufactured goods of the other Party treatment that is less favourable than that which it accords to equivalent goods in new condition. 2. Article 26 applies to import and export prohibitions or restrictions on remanufactured goods. If a Party adopts or maintains import and export prohibitions or restrictions on used goods, it shall not apply those measures to remanufactured goods. 3. A Party may require that remanufactured goods be identified as such for distribution or sale in its territory and that they meet all applicable technical requirements that apply to equivalent goods in new condition. Article 26 Import and export restrictions 1. A Party shall not adopt or maintain any prohibition or restriction on the importation of any good of the other Party or on the exportation or sale for export of any good destined for the territory of the other Party, except in accordance with Article XI of GATT 1994, including its Notes and Supplementary Provisions. To that end, Article XI of GATT 1994 and its Notes and Supplementary Provisions are incorporated into and made part of this Agreement, mutatis mutandis. 2. A Party shall not adopt or maintain: (a) export and import price requirements, except as permitted in enforcement of countervailing and anti-dumping duty orders and undertakings; or (b) import licensing conditioned on the fulfilment of a performance requirement. Article 27 Import and export monopolies A Party shall not designate or maintain an import or export monopoly. For the purposes of this Article, import or export monopoly means the exclusive right or grant of authority by a Party to an entity to import a good from, or export a good to, the other Party. Article 28 Import licensing procedures 1. Each Party shall ensure that all import licensing procedures applicable to trade in goods between the Parties are neutral in application, and are administered in a fair, equitable, non-discriminatory and transparent manner. 2. A Party shall only adopt or maintain licensing procedures as a condition for importation into its territory from the territory of the other Party, if other appropriate procedures to achieve an administrative purpose are not reasonably available. 3. A Party shall not adopt or maintain any non-automatic import licensing procedure, unless it is necessary to implement a measure that is consistent with this Agreement. A Party adopting such non-automatic import licensing procedure shall indicate clearly the measure being implemented through that procedure. 4. Each Party shall introduce and administer any import licensing procedure in accordance with Articles 1 to 3 of the WTO Agreement on Import Licensing Procedures (the "Import Licensing Agreement"). To that end, Articles 1 to 3 of the Import Licensing Agreement are incorporated into and made part of this Agreement mutatis mutandis. 5. Any Party introducing or modifying any import licensing procedure shall make all relevant information available online on an official website. That information shall be made available, whenever practicable, at least 21 days prior to the date of the application of the new or modified licensing procedure and in any event no later than the date of application. That information shall contain the data required under Article 5 of the Import Licensing Agreement. 6. At the request of the other Party, a Party shall promptly provide any relevant information regarding any import licensing procedures that it intends to adopt or that it maintains, including the information referred to in Articles 1 to 3 of the Import Licensing Agreement. 7. For greater certainty, nothing in this Article requires a Party to grant an import licence, or prevents a Party from implementing its obligations or commitments under United Nations Security Council Resolutions or under multilateral non-proliferation regimes and import control arrangements. Article 29 Export licensing procedures 1. Each Party shall publish any new export licensing procedure, or any modification to an existing export licensing procedure, in such a manner as to enable governments, traders and other interested parties to become acquainted with them. Such publication shall take place, whenever practicable, 45 days before the procedure or modification takes effect, and in any case no later than the date such procedure or modification takes effect and, where appropriate, publication shall take place on any relevant government websites. 2. The publication of export licensing procedures shall include the following information: (a) the texts of the Party's export licensing procedures, or of any modifications the Party makes to those procedures; (b) the goods subject to each licensing procedure; (c) for each procedure, a description of the process for applying for a licence and any criteria an applicant must meet to be eligible to apply for a licence, such as possessing an activity licence, establishing or maintaining an investment, or operating through a particular form of establishment in a Party's territory; (d) a contact point or points from which interested persons can obtain further information on the conditions for obtaining an export licence; (e) the administrative body or bodies to which an application or other relevant documentation are to be submitted; (f) a description of any measure or measures being implemented through the export licensing procedure; (g) the period during which each export licensing procedure will be in effect, unless the procedure remains in effect until withdrawn or revised in a new publication; (h) if the Party intends to use a licensing procedure to administer an export quota, the overall quantity and, if applicable, the value of the quota and the opening and closing dates of the quota; and (i) any exemptions or exceptions that replace the requirement to obtain an export licence, how to request or use those exemptions or exceptions, and the criteria for granting them. 3. Within 45 days after the date of entry into force of this Agreement, each Party shall notify the other Party of its existing export licensing procedures. Each Party shall notify to the other Party any new export licensing procedures and any modifications to existing export licensing procedures within 60 days of publication. The notification shall include a reference to the sources where the information required pursuant to paragraph 2 is published and shall include, where appropriate, the address of the relevant government websites. 4. For greater certainty, nothing in this Article requires a Party to grant an export licence, or prevents a Party from implementing its commitments under United Nations Security Council Resolutions as well as under multilateral non-proliferation regimes and export control arrangements including the Wassenaar Arrangement on Export Controls for Conventional Arms and Dual-Use Goods and Technologies, the Australia Group, the Nuclear Suppliers Group, and the Missile Technology Control Regime, or from adopting, maintaining or implementing independent sanctions regimes. Article 30 Customs valuation Each Party shall determine the customs value of goods of the other Party imported into its territory in accordance with Article VII of GATT 1994 and the Customs Valuation Agreement. To that end, Article VII of GATT 1994 including its Notes and Supplementary Provisions, and Articles 1 to 17 of the Customs Valuation Agreement including its Interpretative Notes, are incorporated into and made part of this Agreement, mutatis mutandis. Article 31 Preference utilisation 1. For the purpose of monitoring the functioning of this Agreement and calculating preference utilisation rates, the Parties shall annually exchange import statistics for a 10 year-long period starting one year after the entry into force of this Agreement. Unless the Trade Partnership Committee decides otherwise, this period shall be automatically extended for five years, and thereafter the Trade Partnership Committee may decide to extend it further. 2. The exchange of import statistics shall cover data pertaining to the most recent year available, including value and, where applicable, volume, at the tariff line level for imports of goods of the other Party benefitting from preferential duty treatment under this Agreement and for those that receive non-preferential treatment. Article 32 Trade remedies 1. The Parties affirm their rights and obligations under Article VI of GATT 1994, the Anti-Dumping Agreement, the SCM Agreement, Article XIX of GATT 1994, the Safeguards Agreement, and Article 5 of the Agreement on Agriculture. 2. Chapter 2 of this Title does not apply to anti-dumping, countervailing and safeguard investigations and measures. 3. Each Party shall apply anti-dumping and countervailing measures in accordance with the requirements of the Anti-Dumping Agreement and the SCM Agreement, and pursuant to a fair and transparent process. 4. Provided it does not unnecessarily delay the conduct of the investigation, each interested party in an anti-dumping or countervailing investigation (1) shall be granted a full opportunity to defend its interests. 5. Each Party's investigating authority may, in accordance with the Party's law, consider whether the amount of the anti-dumping duty to be imposed shall be the full margin of dumping or a lesser amount. 6. Each Party's investigating authority shall, in accordance with the Party's law, consider information provided as to whether imposing an anti-dumping or a countervailing duty would not be in the public interest. 7. A Party shall not apply or maintain, with respect to the same good, at the same time: (a) a measure pursuant to Article 5 of the Agreement on Agriculture; and (b) a measure pursuant to Article XIX of GATT 1994 and the Safeguards Agreement. 8. Title I of Part Six does not apply to paragraphs 1 to 6 of this Article. Article 33 Use of existing WTO tariff rate quotas 1. Products originating in one Party shall not be eligible to be imported into the other Party under existing WTO Tariff Rate Quotas ("TRQs") as defined in paragraph 2. This shall include those TRQs as being apportioned between the Parties pursuant to Article XXVIII GATT negotiations initiated by the European Union in WTO document G/SECRET/42/Add.2 and by the United Kingdom in WTO document G/SECRET/44 and as set out in each Party's respective internal legislation. For the purposes of this Article, the originating status of the products shall be determined on the basis of non-preferential rules of origin applicable in the importing Party. 2. For the purposes of paragraph 1, "existing WTO TRQs" means those tariff rate quotas which are WTO concessions of the European Union included in the draft EU28 schedule of concessions and commitments under GATT 1994 submitted to the WTO in document G/MA/TAR/RS/506 as amended by documents G/MA/TAR/RS/506/Add.1 and G/MA/TAR/RS/506/Add.2. Article 34 Measures in case of breaches or circumventions of customs legislation 1. The Parties shall cooperate in preventing, detecting and combating breaches or circumventions of customs legislation, in accordance with their obligations under Chapter 2 of this Title and the Protocol on mutual administrative assistance in customs matters. Each Party shall take appropriate and comparable measures to protect its own and the other Party's financial interests regarding the levying of duties on goods entering the customs territories of the United Kingdom or the Union. 2. Subject to the possibility of exemption for compliant traders under paragraph 7, a Party may temporarily suspend the relevant preferential treatment of the product or products concerned in accordance with the procedure laid down in paragraphs 3 and 4 if: (a) that Party has made a finding, based on objective, compelling and verifiable information, that systematic and large-scale breaches or circumventions of customs legislation have been committed, and; (b) the other Party repeatedly and unjustifiably refuses or otherwise fails to comply with the obligations referred to in paragraph 1. 3. The Party which has made a finding as referred to in paragraph 2 shall notify the Trade Partnership Committee and shall enter into consultations with the other Party within the Trade Partnership Committee with a view to reaching a mutually acceptable solution. 4. If the Parties fail to agree on a mutually acceptable solution within three months after the date of notification, the Party which has made the finding may decide to suspend temporarily the relevant preferential treatment of the product or products concerned. In this case, the Party which made the finding shall notify the temporary suspension, including the period during which it intends the temporary suspension to apply, to the Trade Partnership Committee without delay. 5. The temporary suspension shall apply only for the period necessary to counteract the breaches or circumventions and to protect the financial interests of the Party concerned, and in any case not for longer than six months. The Party concerned shall keep the situation under review and, where it decides that the temporary suspension is no longer necessary, it shall bring it to an end before the end of the period notified to the Trade Partnership Committee. Where the conditions that gave rise to the suspension persist at the expiry of the period notified to the Trade Partnership Committee, the Party concerned may decide to renew the suspension. Any suspension shall be subject to periodic consultations within the Trade Partnership Committee. 6. Each Party shall publish, in accordance with its internal procedures, notices to importers about any decision concerning temporary suspensions referred to in paragraphs 4 and 5. 7. Notwithstanding paragraph 4, if an importer is able to satisfy the importing customs authority that such products are fully compliant with the importing Party's customs legislation, the requirements of this Agreement, and any other appropriate conditions related to the temporary suspension established by the importing Party in accordance with its laws and regulations, the importing Party shall allow the importer to apply for preferential treatment and recover any duties paid in excess of the applicable preferential tariff rates when the products were imported. Article 35 Management of administrative errors In case of systematic errors by the competent authorities or issues concerning the proper management of the preferential system at export, concerning notably the application of the provisions of Chapter 2 of this Title or the application of the Protocol on Mutual Administrative Assistance in Customs Matters, and if these errors or issues lead to consequences in terms of import duties, the Party facing such consequences may request the Trade Partnership Committee to examine the possibility of adopting decisions, as appropriate, to resolve the situation. Article 36 Cultural property 1. The Parties shall cooperate in facilitating the return of cultural property illicitly removed from the territory of a Party, having regard to the principles enshrined in the UNESCO Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property signed in Paris on 17 November 1970. 2. For the purposes of this Article, the following definitions apply: (a) "cultural property" means property classified or defined as being among the national treasures possessing artistic, historic or archaeological value under the respective rules and procedures of each Party; and (b) "illicitly removed from the territory of a Party" means: (i) removed from the territory of a Party on or after 1 January 1993 in breach of that Party's rules on the protection of national treasures or in breach of its rules on the export of cultural property; or (ii) not returned at the end of a period of lawful temporary removal or any breach of another condition governing such temporary removal, on or after 1 January 1993. 3. The competent authorities of the Parties shall cooperate with each other in particular by: (a) notifying the other Party where cultural property is found in their territory and there are reasonable grounds for believing that the cultural property has been illicitly removed from the territory of the other Party; (b) addressing requests of the other Party for the return of cultural property which has been illicitly removed from the territory of that Party; (c) preventing any actions to evade the return of such cultural property, by means of any necessary interim measures; and (d) taking any necessary measures for the physical preservation of cultural property which has been illicitly removed from the territory of the other Party. 4. Each Party shall identify a contact point responsible for communicating with the contact point of the other Party with respect to any matters arising under this Article, including with respect to the notifications and requests referred to in points (a) and (b) of paragraph 3. 5. The envisaged cooperation between the Parties shall involve the customs authorities of the Parties responsible for managing export procedures for cultural property as appropriate and necessary. 6. Title I of Part Six does not apply to this Article. CHAPTER 2 RULES OF ORIGIN SECTION 1 RULES OF ORIGIN Article 37 Objective The objective of this Chapter is to lay down the provisions determining the origin of goods for the purpose of application of preferential tariff treatment under this Agreement, and setting out related origin procedures. Article 38 Definitions For the purposes of this Chapter, the following definitions apply: (a) "classification" means the classification of a product or material under a particular chapter, heading, or sub-heading of the Harmonised System; (b) "consignment" means products which are either sent simultaneously from one exporter to one consignee or covered by a single transport document covering their shipment from the exporter to the consignee or, in the absence of such a document, by a single invoice; (c) "exporter" means a person, located in a Party, who, in accordance with the requirements laid down in the laws and regulations of that Party, exports or produces the originating product and makes out a statement on origin; (d) "importer" means a person who imports the originating product and claims preferential tariff treatment for it; (e) "material" means any substance used in the production of a product, including any components, ingredients, raw materials, or parts; (f) "non-originating material" means a material which does not qualify as originating under this Chapter, including a material whose originating status cannot be determined; (g) "product" means the product resulting from the production, even if it is intended for use as a material in the production of another product; (h) "production" means any kind of working or processing including assembly. Article 39 General requirements 1. For the purposes of applying the preferential tariff treatment by a Party to the originating good of the other Party in accordance with this Agreement, provided that the products satisfy all other applicable requirements of this Chapter, the following products shall be considered as originating in the other Party: (a) products wholly obtained in that Party within the meaning of Article 41; (b) products produced in that Party exclusively from originating materials in that Party; and (c) products produced in that Party incorporating non-originating materials provided they satisfy the requirements set out in Annex 3. 2. If a product has acquired originating status, the non-originating materials used in the production of that product shall not be considered as non-originating when that product is incorporated as a material in another product. 3. The acquisition of originating status shall be fulfilled without interruption in the United Kingdom or the Union. Article 40 Cumulation of origin 1. A product originating in a Party shall be considered as originating in the other Party if that product is used as a material in the production of another product in that other Party. 2. Production carried out in a Party on a non-originating material may be taken into account for the purpose of determining whether a product is originating in the other Party. 3. Paragraphs 1 and 2 do not apply if the production carried out in the other Party does not go beyond the operations referred to in Article 43. 4. In order for an exporter to complete the statement on origin referred to in point (a) of Article 54(2) for a product referred to in paragraph 2 of this Article, the exporter shall obtain from its supplier a supplier's declaration as provided for in Annex 6 or an equivalent document that contains the same information describing the non-originating materials concerned in sufficient detail to enable them to be identified. Article 41 Wholly obtained products 1. The following products shall be considered as wholly obtained in a Party: (a) mineral products extracted or taken from its soil or from its seabed; (b) plants and vegetable products grown or harvested there; (c) live animals born and raised there; (d) products obtained from live animals raised there; (e) products obtained from slaughtered animals born and raised there; (f) products obtained by hunting or fishing conducted there; (g) products obtained from aquaculture there if aquatic organisms, including fish, molluscs, crustaceans, other aquatic invertebrates and aquatic plants are born or raised from seed stock such as eggs, roes, fry, fingerlings, larvae, parr, smolts or other immature fish at a post-larval stage by intervention in the rearing or growth processes to enhance production such as regular stocking, feeding or protection from predators; (h) products of sea fishing and other products taken from the sea outside any territorial sea by a vessel of a Party; (i) products made aboard of a factory ship of a Party exclusively from products referred to in point (h); (j) products extracted from the seabed or subsoil outside any territorial sea provided that they have rights to exploit or work such seabed or subsoil; (k) waste and scrap resulting from production operations conducted there; (l) waste and scrap derived from used products collected there, provided that those products are fit only for the recovery of raw materials; (m) products produced there exclusively from the products specified in points (a) to (l). 2. The terms "vessel of a Party" and "factory ship of a Party" in points (h) and (i) of paragraph 1 mean a vessel and factory ship which: (a) is registered in a Member State or in the United Kingdom; (b) sails under the flag of a Member State or of the United Kingdom; and (c) meets one of the following conditions: (i) it is at least 50 % owned by nationals of a Member State or of the United Kingdom; or (ii) it is owned by legal persons which each: (A) have their head office and main place of business in the Union or the United Kingdom; and (B) are at least 50 % owned by public entities, nationals or legal persons of a Member State or the United Kingdom. Article 42 Tolerances 1. If a product does not satisfy the requirements set out in Annex 3 due to the use of a non-originating material in its production, that product shall nevertheless be considered as originating in a Party, provided that: (a) the total weight of non-originating materials used in the production of products classified under Chapters 2 and 4 to 24 of the Harmonised System, other than processed fishery products classified under Chapter 16, does not exceed 15 % of the weight of the product; (b) the total value of non-originating materials for all other products, except for products classified under Chapters 50 to 63 of the Harmonised System, does not exceed 10 % of the ex-works price of the product; or (c) for a product classified under Chapters 50 to 63 of the Harmonised System, the tolerances set out in Notes 7 and 8 of Annex 2 apply. 2. Paragraph 1 does not apply if the value or weight of non-originating materials used in the production of a product exceeds any of the percentages for the maximum value or weight of non-originating materials as specified in the requirements set out in Annex 3. 3. Paragraph 1 of this Article does not apply to products wholly obtained in a Party within the meaning of Article 41. If Annex 3 requires that the materials used in the production of a product are wholly obtained, paragraphs 1 and 2 of this Article apply. Article 43 Insufficient production 1. Notwithstanding point (c) of Article 39(1), a product shall not be considered as originating in a Party if the production of the product in a Party consists only of one or more of the following operations conducted on non-originating materials: (a) preserving operations such as drying, freezing, keeping in brine and other similar operations where their sole purpose is to ensure that the products remain in good condition during transport and storage; (2) (b) breaking-up or assembly of packages; (c) washing, cleaning; removal of dust, oxide, oil, paint or other coverings; (d) ironing or pressing of textiles and textile articles; (e) simple painting and polishing operations; (f) husking and partial or total milling of rice; polishing and glazing of cereals and rice; bleaching of rice; (g) operations to colour or flavour sugar or form sugar lumps; partial or total milling of sugar in solid form; (h) peeling, stoning and shelling, of fruits, nuts and vegetables; (i) sharpening, simple grinding or simple cutting; (j) sifting, screening, sorting, classifying, grading, matching including the making-up of sets of articles; (k) simple placing in bottles, cans, flasks, bags, cases, boxes, fixing on cards or boards and all other simple packaging operations; (l) affixing or printing marks, labels, logos and other like distinguishing signs on products or their packaging; (m) simple mixing of products, whether or not of different kinds; mixing of sugar with any material; (n) simple addition of water or dilution with water or another substance that does not materially alter the characteristics of the product, or dehydration or denaturation of products; (o) simple assembly of parts of articles to constitute a complete article or disassembly of products into parts; (p) slaughter of animals. 2. For the purposes of paragraph 1, operations shall be considered simple if neither special skills nor machines, apparatus or equipment especially produced or installed are needed for carrying out those operations. Article 44 Unit of qualification 1. For the purposes of this Chapter, the unit of qualification shall be the particular product which is considered as the basic unit when classifying the product under the Harmonised System. 2. For a consignment consisting of a number of identical products classified under the same heading of the Harmonised System, each individual product shall be taken into account when applying the provisions of this Chapter. Article 45 Packing materials and containers for shipment Packing materials and containers for shipment that are used to protect a product during transportation shall be disregarded in determining whether a product is originating. Article 46 Packaging materials and containers for retail sale Packaging materials and containers in which the product is packaged for retail sale, if classified with the product, shall be disregarded in determining the origin of the product, except for the purposes of calculating the value of non-originating materials if the product is subject to a maximum value of non-originating materials in accordance with Annex 3. Article 47 Accessories, spare parts and tools 1. Accessories, spare parts, tools and instructional or other information materials shall be regarded as one product with the piece of equipment, machine, apparatus or vehicle in question if they: (a) are classified and delivered with, but not invoiced separately from, the product; and (b) are of the types, quantities and value which are customary for that product. 2. Accessories, spare parts, tools and instructional or other information materials referred to paragraph 1 shall be disregarded in determining the origin of the product except for the purposes of calculating the value of non-originating materials if a product is subject to a maximum value of non-originating materials as set out in Annex 3. Article 48 Sets Sets, as defined in General Rule 3 for the Interpretation of the Harmonised System, shall be considered as originating in a Party if all of their components are originating. If a set is composed of originating and non-originating components, the set as a whole shall be considered as originating in a Party if the value of the non-originating components does not exceed 15 % of the ex-works price of the set. Article 49 Neutral elements In order to determine whether a product is originating in a Party, it shall not be necessary to determine the origin of the following elements, which might be used in its production: (a) fuel, energy, catalysts and solvents; (b) plant, equipment, spare parts and materials used in the maintenance of equipment and buildings; (c) machines, tools, dies and moulds; (d) lubricants, greases, compounding materials and other materials used in production or used to operate equipment and buildings; (e) gloves, glasses, footwear, clothing, safety equipment and supplies; (f) equipment, devices and supplies used for testing or inspecting the product; and (g) other materials used in the production which are not incorporated into the product nor intended to be incorporated into the final composition of the product. Article 50 Accounting segregation 1. Originating and non-originating fungible materials or fungible products shall be physically segregated during storage in order to maintain their originating and non-originating status. 2. For the purpose of paragraph 1, "fungible materials" or "fungible products" means materials or products that are of the same kind and commercial quality, with the same technical and physical characteristics, and that cannot be distinguished from one another for origin purposes. 3. Notwithstanding paragraph 1, originating and non-originating fungible materials may be used in the production of a product without being physically segregated during storage if an accounting segregation method is used. 4. Notwithstanding paragraph 1, originating and non-originating fungible products classified under Chapters 10, 15, 27, 28, 29, headings 32.01 to 32.07, or headings 39.01 to 39.14 of the Harmonised System may be stored in a Party before exportation to the other Party without being physically segregated, provided that an accounting segregation method is used. 5. The accounting segregation method referred to in paragraphs 3 and 4 shall be applied in conformity with a stock management method under accounting principles which are generally accepted in the Party. 6. The accounting segregation method shall be any method that ensures that at any time no more materials or products receive originating status than would be the case if the materials or products had been physically segregated. 7. A Party may require, under conditions set out in its laws or regulations, that the use of an accounting segregation method is subject to prior authorisation by the customs authorities of that Party. The customs authorities of the Party shall monitor the use of such authorisations and may withdraw an authorisation if the holder makes improper use of the accounting segregation method or fails to fulfil any of the other conditions laid down in this Chapter. Article 51 Returned products If a product originating in a Party exported from that Party to a third country returns to that Party, it shall be considered as a non-originating product unless it can be demonstrated to the satisfaction of the customs authority of that Party that the returning product: (a) is the same as that exported; and (b) has not undergone any operation other than what was necessary to preserve it in good condition while in that third country or while being exported. Article 52 Non-alteration 1. An originating product declared for home use in the importing Party shall not, after exportation and prior to being declared for home use, have been altered, transformed in any way or subjected to operations other than to preserve it in good condition or than adding or affixing marks, labels, seals or any other documentation to ensure compliance with specific domestic requirements of the importing Party. 2. The storage or exhibition of a product may take place in a third country, provided that the product remains under customs supervision in that third country. 3. The splitting of consignments may take place in a third country if it is carried out by the exporter or under the responsibility of the exporter, provided that the consignments remain under customs supervision in that third country. 4. In the case of doubt as to whether the requirements provided for in paragraphs 1 to 3 are complied with, the customs authority of the importing Party may request the importer to provide evidence of compliance with those requirements, which may be given by any means, including contractual transport documents such as bills of lading or factual or concrete evidence based on the marking or numbering of packages or any evidence related to the product itself. Article 53 Review of drawback of, or exemption from, customs duties Not earlier than two years from the entry into force of this Agreement, at the request of either Party, the Trade Specialised Committee on Customs Cooperation and Rules of Origin shall review the Parties' respective duty drawback and inward-processing schemes. For that purpose, at the request of a Party, no later than 60 days from that request, the other Party shall provide the requesting Party with available information and detailed statistics covering the period from the entry into force of this Agreement, or the previous five years if that period is shorter, on the operation of its duty-drawback and inward-processing scheme. In the light of this review, the Trade Specialised Committee on Customs Cooperation and Rules of Origin may make recommendations to the Partnership Council for the amendment of the provisions of this Chapter and its Annexes, with a view to introducing limitations or restrictions with respect to drawback of or exemption from customs duties. SECTION 2 ORIGIN PROCEDURES Article 54 Claim for preferential tariff treatment 1. The importing Party, on importation, shall grant preferential tariff treatment to a product originating in the other Party within the meaning of this Chapter on the basis of a claim by the importer for preferential tariff treatment. The importer shall be responsible for the correctness of the claim for preferential tariff treatment and for compliance with the requirements provided for in this Chapter. 2. A claim for preferential tariff treatment shall be based on: (a) a statement on origin that the product is originating made out by the exporter; or (b) the importer's knowledge that the product is originating. 3. The importer making the claim for preferential tariff treatment based on a statement on origin as referred to in point (a) of paragraph 2 shall keep the statement on origin and, when required by the customs authority of the importing Party, shall provide a copy thereof to that customs authority. Article 55 Time of the claim for preferential tariff treatment 1. A claim for preferential tariff treatment and the basis for that claim as referred to in Article 54(2) shall be included in the customs import declaration in accordance with the laws and regulations of the importing Party. 2. By way of derogation from paragraph 1 of this Article, if the importer did not make a claim for preferential tariff treatment at the time of importation, the importing Party shall grant preferential tariff treatment and repay or remit any excess customs duty paid provided that: (a) the claim for preferential tariff treatment is made no later than three years after the date of importation, or such longer time period as specified in the laws and regulations of the importing Party; (b) the importer provides the basis for the claim as referred to in Article 54(2); and (c) the product would have been considered originating and would have satisfied all other applicable requirements within the meaning of Section 1 of this Chapter if it had been claimed by the importer at the time of importation. The other obligations applicable to the importer under Article 54 remain unchanged. Article 56 Statement on origin 1. A statement on origin shall be made out by an exporter of a product on the basis of information demonstrating that the product is originating, including, information on the originating status of materials used in the production of the product. The exporter shall be responsible for the correctness of the statement on origin and the information provided. 2. A statement on origin shall be made out using one of the language versions set out in Annex 7 in an invoice or on any other document that describes the originating product in sufficient detail to enable the identification of that product. The exporter shall be responsible for providing sufficient detail to allow the identification of the originating product. The importing Party shall not require the importer to submit a translation of the statement on origin. 3. A statement on origin shall be valid for 12 months from the date it was made out or for such longer period as provided by the Party of import up to a maximum of 24 months. 4. A statement on origin may apply to: (a) a single shipment of one or more products imported into a Party; or (b) multiple shipments of identical products imported into a Party within the period specified in the statement on origin, which shall not exceed 12 months. 5. If, at the request of the importer, unassembled or disassembled products within the meaning of General Rule 2(a) for the Interpretation of the Harmonised System that fall within Sections XV to XXI of the Harmonised System are imported by instalments, a single statement on origin for such products may be used in accordance with the requirements laid down by the customs authority of the importing Party. Article 57 Discrepancies The customs authority of the importing Party shall not reject a claim for preferential tariff treatment due to minor errors or discrepancies in the statement on origin, or for the sole reason that an invoice was issued in a third country. Article 58 Importer's knowledge 1. For the purposes of a claim for preferential tariff treatment that is made under point (b) of Article 54(2), the importer's knowledge that a product is originating in the exporting Party shall be based on information demonstrating that the product is originating and satisfies the requirements provided for in this Chapter. 2. Before claiming the preferential treatment, in the event that an importer is unable to obtain the information referred to in paragraph 1 of this Article as a result of the exporter deeming that information to be confidential information or for any other reason, the exporter may provide a statement on origin so that the importer may claim the preferential tariff treatment on the basis of point (a) of Article 54(2). Article 59 Record-keeping requirements 1. For a minimum of three years after the date of importation of the product, an importer making a claim for preferential tariff treatment for a product imported into the importing Party shall keep: (a) if the claim was based on a statement on origin, the statement on origin made out by the exporter; or (b) if the claim was based on the importer's knowledge, all records demonstrating that the product satisfies the requirements for obtaining originating status. 2. An exporter who has made out a statement on origin shall, for a minimum of four years after that statement on origin was made out, keep a copy of the statement on origin and all other records demonstrating that the product satisfies the requirements to obtain originating status. 3. The records to be kept in accordance with this Article may be held in electronic format. Article 60 Small consignments 1. By way of derogation from Articles 54 to 58, provided that the product has been declared as meeting the requirements of this Chapter and the customs authority of the importing Party has no doubts as to the veracity of that declaration, the importing Party shall grant preferential tariff treatment to: (a) a product sent in a small package from private persons to private persons; (b) a product forming part of a traveller's personal luggage; and (c) for the United Kingdom, in addition to points (a) and (b) of this Article, other low value consignments. 2. The following products are excluded from the application of paragraph 1 of this Article: (a) products, the importation of which forms part of a series of importations that may reasonably be considered to have been made separately for the purpose of avoiding the requirements of Article 54; (b) for the Union: (i) a product imported by way of trade; the imports which are occasional and consist solely of products for the personal use of the recipients or travellers or their families are not be considered as imports by way of trade if it is evident from the nature and quantity of the products that no commercial purpose is intended; and (ii) products, the total value of which exceeds EUR 500 in the case of products sent in small packages, or EUR 1 200 in the case of products forming part of a traveller's personal luggage. The amounts to be used in a given national currency shall be the equivalent in that currency of the amounts expressed in euro as at the first working day of October. The exchange rate amounts shall be those published for that day by the European Central Bank, unless a different amount is communicated to the European Commission by 15 October, and shall apply from 1 January the following year. The European Commission shall notify the United Kingdom of the relevant amounts. The Union may establish other limits which it will communicate to the United Kingdom; and (c) for the United Kingdom, products whose total value exceeds the limits set under the domestic law of the United Kingdom. The United Kingdom will communicate these limits to the Union. 3. The importer shall be responsible for the correctness of the declaration and for the compliance with the requirements provided for in this Chapter. The record-keeping requirements set out in Article 59 shall not apply to the importer under this Article. Article 61 Verification 1. The customs authority of the importing Party may conduct a verification as to whether a product is originating or whether the other requirements of this Chapter are satisfied, on the basis of risk assessment methods, which may include random selection. Such verifications may be conducted by means of a request for information from the importer who made the claim referred to in Article 54, at the time the import declaration is submitted, before the release of the products, or after the release of the products. 2. The information requested pursuant to paragraph 1 shall cover no more than the following elements: (a) if the claim was based on a statement on origin, that statement on origin; and (b) information pertaining to the fulfilment of origin criteria, which is: (i) where the origin criterion is "wholly obtained", the applicable category (such as harvesting, mining, fishing) and the place of production; (ii) where the origin criterion is based on change in tariff classification, a list of all the non-originating materials, including their tariff classification (in 2, 4 or 6-digit format, depending on the origin criterion); (iii) where the origin criterion is based on a value method, the value of the final product as well as the value of all the non-originating materials used in the production of that product; (iv) where the origin criterion is based on weight, the weight of the final product as well as the weight of the relevant non-originating materials used in the final product; (v) where the origin criterion is based on a specific production process, a description of that specific process. 3. When providing the requested information, the importer may add any other information that it considers relevant for the purpose of verification. 4. If the claim for preferential tariff treatment is based on a statement on origin, the importer shall provide that statement on origin but may reply to the customs authority of the importing Party that the importer is not in a position to provide the information referred to in point (b) of paragraph 2. 5. If the claim for preferential tariff treatment is based on the importer's knowledge, after having first requested information in accordance with paragraph 1, the customs authority of the importing Party conducting the verification may request the importer to provide additional information if that customs authority considers that additional information is necessary in order to verify the originating status of the product or whether the other requirements of this Chapter are met. The customs authority of the importing Party may request the importer for specific documentation and information, if appropriate. 6. If the customs authority of the importing Party decides to suspend the granting of preferential tariff treatment to the product concerned while awaiting the results of the verification, the release of the products shall be offered to the importer subject to appropriate precautionary measures including guarantees. Any suspension of preferential tariff treatment shall be terminated as soon as possible after the customs authority of the importing Party has ascertained the originating status of the products concerned, or the fulfilment of the other requirements of this Chapter. Article 62 Administrative cooperation 1. In order to ensure the proper application of this Chapter, the Parties shall cooperate, through the customs authority of each Party, in verifying whether a product is originating and is in compliance with the other requirements provided for in this Chapter. 2. If the claim for preferential tariff treatment was based on a statement on origin, as appropriate after having first requested information in accordance with Article 61(1) and based on the reply from the importer, the customs authority of the importing Party conducting the verification may also request information from the customs authority of the exporting Party within a period of two years after the importation of the products, or from the moment the claim is made pursuant to point (a) of Article 55(2) if the customs authority of the importing Party conducting the verification considers that additional information is necessary in order to verify the originating status of the product or to verify that the other requirements provided for in this Chapter have been met. The request for information shall include the following elements: (a) the statement on origin; (b) the identity of the customs authority issuing the request; (c) the name of the exporter; (d) the subject and scope of the verification; and (e) any relevant documentation. In addition, the customs authority of the importing Party may request the customs authority of the exporting Party to provide specific documentation and information, where appropriate. 3. The customs authority of the exporting Party may, in accordance with its laws and regulations, request documentation or examination by calling for any evidence, or by visiting the premises of the exporter, to review records and observe the facilities used in the production of the product. 4. Without prejudice to paragraph 5, the customs authority of the exporting Party receiving the request referred to in paragraph 2 shall provide the customs authority of the importing Party with the following information: (a) the requested documentation, where available; (b) an opinion on the originating status of the product; (c) the description of the product that is subject to examination and the tariff classification relevant to the application of this Chapter; (d) a description and explanation of the production process that is sufficient to support the originating status of the product; (e) information on the manner in which the examination of the product was conducted; and (f) supporting documentation, where appropriate. 5. The customs authority of the exporting Party shall not provide the information referred to in points (a), (d) and (f) of paragraph 4 to the customs authority of the importing Party if that information is deemed confidential by the exporter. 6. Each Party shall notify the other Party of the contact details of the customs authorities and shall notify the other Party of any change to those contact details within 30 days after the date of the change. Article 63 Denial of preferential tariff treatment 1. Without prejudice to paragraph 3, the customs authority of the importing Party may deny preferential tariff treatment, if: (a) within three months after the date of a request for information pursuant to Article 61(1): (i) no reply has been provided by the importer; (ii) where the claim for preferential tariff treatment was based on a statement on origin, no statement on origin has been provided; or (iii) where the claim for preferential tariff treatment was based on the importer's knowledge, the information provided by the importer is inadequate to confirm that the product is originating; (b) within three months after the date of a request for additional information pursuant to Article 61(5): (i) no reply has been provided by the importer; or (ii) the information provided by the importer is inadequate to confirm that the product is originating; (c) within 10 months (3) after the date of a request for information pursuant to Article 62(2): (i) no reply has been provided by the customs authority of the exporting Party; or (ii) the information provided by the customs authority of the exporting Party is inadequate to confirm that the product is originating. 2. The customs authority of the importing Party may deny preferential tariff treatment to a product for which an importer claims preferential tariff treatment where the importer fails to comply with requirements under this Chapter other than those relating to the originating status of the products. 3. If the customs authority of the importing Party has sufficient justification to deny preferential tariff treatment under paragraph 1 of this Article, in cases where the customs authority of the exporting Party has provided an opinion pursuant to point (b) of Article 62(4) confirming the originating status of the products, the customs authority of the importing Party shall notify the customs authority of the exporting Party of its intention to deny the preferential tariff treatment within two months after the date of receipt of that opinion. If such notification is made, consultations shall be held at the request of either Party, within three months after the date of the notification. The period for consultation may be extended on a case-by-case basis by mutual agreement between the customs authorities of the Parties. The consultation may take place in accordance with the procedure set by the Trade Specialised Committee on Customs Cooperation and Rules of Origin. Upon the expiry of the period for consultation, if the customs authority of the importing Party cannot confirm that the product is originating, it may deny the preferential tariff treatment if it has a sufficient justification for doing so and after having granted the importer the right to be heard. However, when the customs authority of the exporting Party confirms the originating status of the products and provides justification for such conclusion, the customs authority of the importing Party shall not deny preferential tariff treatment to a product on the sole ground that Article 62(5) has been applied. 4. In all cases, the settlement of differences between the importer and the customs authority of the Party of import shall be under the law of the Party of import. Article 64 Confidentiality 1. Each Party shall maintain, in accordance with its laws and regulations, the confidentiality of any information provided to it by the other Party, pursuant to this Chapter, and shall protect that information from disclosure. 2. Where, notwithstanding Article 62(5), confidential business information has been obtained from the exporter by the customs authority of the exporting Party or importing Party through the application of Articles 61 and 62, that information shall not be disclosed. 3. Each Party shall ensure that confidential information collected pursuant to this Chapter shall not be used for purposes other than the administration and enforcement of decisions and determinations relating to origin and to customs matters, except with the permission of the person or Party who provided the confidential information. 4. Notwithstanding paragraph 3, a Party may allow information collected pursuant to this Chapter to be used in any administrative, judicial, or quasi-judicial proceedings instituted for failure to comply with customs-related laws implementing this Chapter. A Party shall notify the person or Party who provided the information in advance of such use. Article 65 Administrative measures and sanctions Each Party shall ensure the effective enforcement of this Chapter. Each Party shall ensure that the competent authorities are able to impose administrative measures, and, where appropriate, sanctions, in accordance with its laws and regulations, on any person who draws up a document, or causes a document to be drawn up, which contains incorrect information that was provided for the purpose of obtaining a preferential tariff treatment for a product, who does not comply with the requirements set out in Article 59, or who does not provide the evidence, or refuses to submit to a visit, as referred to in Article 62(3). SECTION 3 OTHER PROVISIONS Article 66 Ceuta and Melilla 1. For purposes of this Chapter, in the case of the Union, the term "Party" does not include Ceuta and Melilla. 2. Products originating in the United Kingdom, when imported into Ceuta and Melilla, shall in all respects be subject to the same customs treatment under this Agreement as that which is applied to products originating in the customs territory of the Union under Protocol 2 of the Act of Accession of the Kingdom of Spain and the Portuguese Republic to the European Union. The United Kingdom shall grant to imports of products covered by this Agreement and originating in Ceuta and Melilla the same customs treatment as that which is granted to products imported from and originating in the Union. 3. The rules of origin and origin procedures referred to in this Chapter apply mutatis mutandis to products exported from the United Kingdom to Ceuta and Melilla and to products exported from Ceuta and Melilla to the United Kingdom. 4. Ceuta and Melilla shall be considered as a single territory. 5. Article 40 applies to import and exports of products between the Union, the United Kingdom and Ceuta and Melilla. 6. The exporters shall enter "the United Kingdom" or "Ceuta and Melilla" in field 3 of the text of the statement on origin, depending on the origin of the product. 7. The customs authority of the Kingdom of Spain shall be responsible for the application and implementation of this Chapter in Ceuta and Melilla. Article 67 Transitional provisions for products in transit or storage The provisions of this Agreement may be applied to products which comply with the provisions of this Chapter and which on the date of entry into force of this Agreement are either in transit from the exporting Party to the importing Party or under customs control in the importing Party without payment of import duties and taxes, subject to the making of a claim for preferential tariff treatment referred to in Article 54 to the customs authority of the importing Party, within 12 months of that date. Article 68 Amendment to this Chapter and its Annexes The Partnership Council may amend this Chapter and its Annexes. CHAPTER 3 SANITARY AND PHYTOSANITARY MEASURES Article 69 Objectives The objectives of this Chapter are to: (a) protect human, animal and plant life or health in the territories of the Parties while facilitating trade between the Parties; (b) further the implementation of the SPS Agreement; (c) ensure that the Parties' sanitary and phytosanitary ("SPS") measures do not create unnecessary barriers to trade; (d) promote greater transparency and understanding on the application of each Party's SPS measures; (e) enhance cooperation between the Parties in the fight against antimicrobial resistance, promotion of sustainable food systems, protection of animal welfare, and on electronic certification; (f) enhance cooperation in the relevant international organisations to develop international standards, guidelines and recommendations on animal health, food safety and plant health; and (g) promote implementation by each Party of international standards, guidelines and recommendations. Article 70 Scope 1. This Chapter applies to all SPS measures of a Party that may, directly or indirectly, affect trade between the Parties. 2. This Chapter also lays down separate provisions regarding cooperation on animal welfare, antimicrobial resistance and sustainable food systems. Article 71 Definitions 1. For the purposes of this Chapter, the following definitions apply: (a) the definitions contained in Annex A of the SPS Agreement; (b) the definitions adopted under the auspices of the Codex Alimentarius Commission (the "Codex"); (c) the definitions adopted under the auspices of the World Organisation for Animal Health (the "OIE"); and (d) the definitions adopted under the auspices of the International Plant Protection Convention (the "IPPC"). 2. For the purposes of this Chapter, the following definitions apply: (a) "import conditions" means any SPS measures that are required to be fulfilled for the import of products; and (b) "protected zone" for a specified regulated plant pest means an officially defined geographical area in which that pest is not established in spite of favourable conditions and its presence in other parts of the territory of the Party, and into which that pest is not allowed to be introduced. 3. The Trade Specialised Committee on Sanitary and Phytosanitary Measures may adopt other definitions for the purposes of this Chapter, taking into consideration the glossaries and definitions of the relevant international organisations, such as the Codex, OIE and IPPC. 4. The definitions under the SPS Agreement prevail to the extent that there is an inconsistency between the definitions adopted by the Trade Specialised Committee on Sanitary and Phytosanitary Measures or adopted under the auspices of the Codex, the OIE, the IPPC and the definitions under the SPS Agreement. In the event of an inconsistency between definitions adopted by the Trade Specialised Committee on Sanitary and Phytosanitary Measures and the definitions set out in the Codex, OIE or IPPC, the definitions set out in the Codex, OIE or IPPC shall prevail. Article 72 Rights and obligations The Parties reaffirm their rights and obligations under the SPS Agreement. This includes the right to adopt measures in accordance with Article 5(7) of the SPS Agreement. Article 73 General principles 1. The Parties shall apply SPS measures for achieving their appropriate level of protection that are based on risk assessments in accordance with relevant provisions, including Article 5 of the SPS Agreement. 2. The Parties shall not use SPS measures to create unjustified barriers to trade. 3. Regarding trade-related SPS procedures and approvals established under this Chapter, each Party shall ensure that those procedures and related SPS measures: (a) are initiated and completed without undue delay; (b) do not include unnecessary, scientifically and technically unjustified or unduly burdensome information requests that might delay access to each other's markets; (c) are not applied in a manner which would constitute arbitrary or unjustifiable discrimination against the other Party's entire territory or parts of the other Party's territory where identical or similar SPS conditions exist; and (d) are proportionate to the risks identified and not more trade restrictive than necessary to achieve the importing Party's appropriate level of protection. 4. The Parties shall not use the procedures referred to in paragraph 3, or any requests for additional information, to delay access to their markets without scientific and technical justification. 5. Each Party shall ensure that any administrative procedure it requires concerning the import conditions on food safety, animal health or plant health is not more burdensome or trade restrictive than necessary to give the importing Party adequate confidence that these conditions are met. Each Party shall ensure that the negative effects on trade of any administrative procedures are kept to a minimum and that the clearance processes remain simple and expeditious while meeting the importing Party's conditions. 6. The importing Party shall not put in place any additional administrative system or procedure that unnecessarily hampers trade. Article 74 Official certification 1. Where the importing Party requires official certificates, the model certificates shall be: (a) set in line with the principles as laid down in the international standards of the Codex, the IPPC and the OIE; and (b) applicable to imports from all parts of the territory of the exporting Party. 2. The Trade Specialised Committee on Sanitary and Phytosanitary Measures may agree on specific cases where the model certificates referred to in paragraph 1 would be established only for a part or parts of the territory of the exporting Party. The Parties shall promote the implementation of electronic certification and other technologies to facilitate trade. Article 75 Import conditions and procedures 1. Without prejudice to the rights and obligations each Party has under the SPS Agreement and this Chapter, the import conditions of the importing Party shall apply to the entire territory of the exporting Party in a consistent manner. 2. The exporting Party shall ensure that products exported to the other Party, such as animals and animal products, plants and plant products, or other related objects, meet the SPS requirements of the importing Party. 3. The importing Party may require that imports of particular products are subject to authorisation. Such authorisation shall be granted where a request is made by the relevant competent authority of the exporting Party which objectively demonstrates, to the satisfaction of the importing Party, that the authorisation requirements of the importing Party are fulfilled. The relevant competent authority of the exporting Party may make a request for authorisation in respect of the entire territory of the exporting Party. The importing Party shall grant such requests on that basis, where they fulfil the authorisation requirements of the importing Party as set out in this paragraph. 4. The importing Party shall not introduce authorisation requirements which are additional to those which apply at the end of the transition period, unless the application of such requirements to further products is justified to mitigate a significant risk to human, animal or plant health. 5. The importing Party shall establish and communicate to the other Party import conditions for all products. The importing Party shall ensure that its import conditions are applied in a proportionate and non-discriminatory manner. 6. Without prejudice to provisional measures under Article 5(7) of the SPS Agreement, for products, or other related objects, where a phytosanitary concern exists, the import conditions shall be restricted to measures to protect against regulated pests of the importing Party and shall be applicable to the entire territory of the exporting Party. 7. Notwithstanding paragraphs 1 and 3, in the case of import authorisation requests for a specific product, where the exporting Party has requested to be examined only for a part, or certain parts, of its territory (in the case of the Union, individual Member States), the importing Party shall promptly proceed to the examination of that request. Where the importing Party receives requests in respect of the specific product from more than one part of the exporting Party, or, where further requests are received in respect of a product which has already been authorised, the importing Party shall expedite completion of the authorisation procedure, taking into account the identical or similar SPS regime applicable in the different parts of the exporting Party. 8. Each Party shall ensure that all SPS control, inspection and approval procedures are initiated and completed without undue delay. Information requirements shall be limited to what is necessary for the approval process to take into account information already available in the importing Party, such as on the legislative framework and audit reports of the exporting Party. 9. Except in duly justified circumstances related to its level of protection, each Party shall provide a transition period between the publication of any changes to its approval procedures and their application to allow the other Party to become familiar with and adapt to such changes. Each Party shall not unduly prolong the approval process for applications submitted prior to publication of the changes. 10. In relation to the processes set out in paragraphs 3 to 8, the following actions shall be taken: (a) as soon as the importing Party has positively concluded its assessment, it shall promptly take all necessary legislative and administrative measures to allow trade to take place without undue delay; (b) the exporting Party shall: (i) provide all relevant information required by the importing Party; and (ii) give reasonable access to the importing Party for audit and other relevant procedures. (c) the importing party shall establish a list of regulated pests for products, or other related objects, where a phytosanitary concern exists. That list shall contain: (i) the pests not known to occur within any part of its own territory; (ii) the pests known to occur within its own territory and under official control; (iii) the pests known to occur within parts of its own territory and for which pest free areas or protected zones are established; and (iv) non-quarantine pests known to occur within its own territory and under official control for specified planting material. 11. The importing Party shall accept consignments without requiring that the importing Party verifies compliance of those consignments before their departure from the territory of the exporting Party. 12. A Party may collect fees for the costs incurred to conduct specific SPS frontier checks, which should not exceed the recovery of the costs. 13. The importing Party shall have the right to carry out import checks on products imported from the exporting Party for the purposes of ensuring compliance with its SPS import requirements. 14. The import checks carried out on products imported from the exporting Party shall be based on the SPS risk associated with such importations. Import checks shall be carried out only to the extent necessary to protect human, animal or plant life and health, without undue delay and with a minimum effect on trade between the Parties. 15. Information on the proportion of products from the exporting Party checked at import shall be made available by the importing Party upon request of the exporting Party. 16. If import checks reveal non-compliance with the relevant import conditions the action taken by the importing Party must be based on an assessment of the risk involved and not be more trade restrictive than required to achieve the Party's appropriate level of SPS protection. Article 76 Lists of approved establishments 1. Whenever justified, the importing Party may maintain a list of approved establishments meeting its import requirements as a condition to allow imports of animal products from these establishments. 2. Unless justified to mitigate a significant risk to human or animal health, lists of approved establishments shall only be required for the products for which they were required at the end of the transition period. 3. The exporting Party shall inform the importing Party of its list of establishments meeting the importing Party's conditions which shall be based on guarantees provided by the exporting Party. 4. Upon a request from the exporting Party, the importing Party shall approve establishments which are situated in the territory of the exporting Party, based on guarantees provided by the exporting Party, without prior inspection of individual establishments. 5. Unless the importing Party requests additional information and subject to guarantees being provided by the exporting party, the importing Party shall take the necessary legislative or administrative measures, in accordance with its applicable legal procedures, to allow imports from those establishments without undue delay. 6. The list of the approved establishments shall be made publicly available by the importing Party. 7. Where the importing Party decides to reject the request of the exporting Party to accept adding an establishment to the list of approved establishments, it shall inform the exporting Party without delay and shall submit a reply, including information about the non-conformities which led to the rejection of the establishment's approval. Article 77 Transparency and exchange of information 1. Each Party shall pursue transparency as regards SPS measures applicable to trade and shall for those purposes undertake the following actions: (a) promptly communicate to the other Party any changes to its SPS measures and approval procedures, including changes that may affect its capacity to fulfil the SPS import requirements of the other Party for certain products; (b) enhance mutual understanding of its SPS measures and their application; (c) exchange information with the other Party on matters related to the development and application of SPS measures, including the progress on new available scientific evidence, that affect, or may affect, trade between the Parties with a view to minimising negative trade effects; (d) upon request of the other Party, communicate the conditions that apply for the import of specific products within 20 working days; (e) upon request of the other Party, communicate the state of play of the procedure for the authorisation of specific products within 20 working days; (f) communicate to the other Party any significant change to the structure or organisation of a Party's competent authority; (g) on request, communicate the results of a Party's official control and a report that concerns the results of the control carried out; (h) on request, communicate the results of an import check provided for in case of a rejected or a non-compliant consignment; and (i) on request, communicate, without undue delay, a risk assessment or scientific opinion produced by a Party that is relevant to this Chapter. 2. Where a Party has made available the information in paragraph 1 via notification to the WTO's Central Registry of Notifications or to the relevant international standard-setting body, in accordance with its relevant rules, the requirements in paragraph 1, as they apply to that information, are fulfilled. Article 78 Adaptation to regional conditions 1. The Parties shall recognise the concept of zoning including disease or pest-free areas, protected zones and areas of low disease or pest prevalence and shall apply it to the trade between the Parties, in accordance with the SPS Agreement, including the guidelines to further the practical implementation of Article 6 of the SPS Agreement (WTO/SPS Committee Decision G/SPS/48) and the relevant recommendations, standards and guidelines of the OIE and IPPC. The Trade Specialised Committee on Sanitary and Phytosanitary Measures may define further details for these procedures, taking into account any relevant SPS Agreement, OIE and IPPC standards, guidelines or recommendations. 2. The Parties may also agree to cooperate on the concept of compartmentalisation as referred to in Chapters 4.4 and 4.5 of the OIE Terrestrial Animal Health Code and Chapters 4.1 and 4.2 of the OIE Aquatic Animal Health Code. 3. When establishing or maintaining the zones referred to in paragraph 1, the Parties shall consider factors such as geographical location, ecosystems, epidemiological surveillance and the effectiveness of SPS controls. 4. With regard to animals and animal products, when establishing or maintaining import conditions upon the request of the exporting Party, the importing Party shall recognise the disease-free areas established by the exporting Party as a basis for consideration towards the determination of allowing or maintaining the import, without prejudice to paragraphs 8 and 9. 5. The exporting Party shall identify the parts of its territory referred to in paragraph 4 and, if requested, provide a full explanation and supporting data based on the OIE standards, or in other ways established by the Trade Specialised Committee on Sanitary and Phytosanitary Measures, based on the knowledge acquired through experience of the exporting Party's relevant authorities. 6. With regard to plants, plant products, and other related objects, when establishing or maintaining phytosanitary import conditions on request of the exporting Party, the importing Party shall recognise the pest-free areas, pest-free places of production, pest-free production sites, areas of low pest prevalence and protected zones established by the exporting Party as a basis for consideration towards the determination to allow or maintain the import, without prejudice to paragraphs 8 and 9. 7. The exporting Party shall identify its pest-free areas, pest-free places of production, pest-free production sites and areas of low pest prevalence or protected zones. If requested by the importing Party, the exporting Party shall provide a full explanation and supporting data based on the International Standards for Phytosanitary Measures developed under the IPPC, or in other ways established by the Trade Specialised Committee on Sanitary and Phytosanitary Measures, based on the knowledge acquired through experience of the exporting Party's relevant phytosanitary authorities. 8. The Parties shall recognise disease-free areas and protected zones which are in place at the end of the transition period. 9. Paragraph 8 shall also apply to subsequent adaptations to the disease-free areas and protected zones (in the case of the United Kingdom pest-free areas), except in cases of significant changes in the disease or pest situations. 10. The Parties may carry out audits and verifications pursuant to Article 79 to implement paragraphs 4 to 9 of this Article. 11. The Parties shall establish close cooperation with the objective of maintaining confidence in the procedures in relation to the establishment of disease- or pest-free areas, pest-free places of production, pest-free production sites and areas of low pest or disease prevalence and protected zones, with the aim to minimise trade disruption. 12. The importing Party shall base its own determination of the animal or plant health status of the exporting Party or parts thereof on the information provided by the exporting Party in accordance with the SPS Agreement, OIE and IPPC standards, and take into consideration any determination made by the exporting Party. 13. Where the importing Party does not accept the determination made by the exporting Party as referred to in paragraph 12 of this Article, the importing Party shall objectively justify and explain to the exporting Party the reasons for that rejection and, upon request, hold consultations, in accordance with Article 80(2). 14. Each Party shall ensure that the obligations set out in paragraphs 4 to 9, 12 and 13 are carried out without undue delay. The importing Party will expedite the recognition of the disease or pest status when the status has been recovered after an outbreak. 15. Where a Party considers that a specific region has a special status with respect to a specific disease and which fulfils the criteria laid down in the OIE Terrestrial Animal Health Code Chapter 1.2 or the OIE Aquatic Animal Health Code Chapter 1.2, it may request recognition of this status. The importing Party may request additional guarantees in respect of imports of live animals and animal products appropriate to the agreed status. Article 79 Audits and verifications 1. The importing Party may carry out audits and verifications of the following: (a) all or part of the other Party's authorities' inspection and certification system; (b) the results of the controls carried out under the exporting Party's inspection and certification system. 2. The Parties shall carry out those audits and verifications in accordance with the provisions of the SPS Agreement, taking into account the relevant international standards, guidelines and recommendations of the Codex, OIE or IPPC. 3. For the purposes of carrying out such audits and verifications, the importing Party may conduct audits and verifications by means of requests of information from the exporting Party or audit and verification visits to the exporting Party, which may include: (a) an assessment of all or part of the responsible authorities' total control programme, including, where appropriate, reviews of regulatory audit and inspection activities; (b) on-the-spot checks; and (c) the collection of information and data to assess the causes of recurring or emerging problems in relation to exports of products. 4. The importing Party shall share with the exporting Party the results and conclusions of the audits and verifications carried out pursuant to paragraph 1. The importing Party may make these results publicly available. 5. Prior to the commencement of an audit or verification, the Parties shall discuss the objectives and scope of the audit or verification, the criteria or requirements against which the exporting Party will be assessed, and the itinerary and procedures for conducting the audit or verification which shall be laid down in an audit or verification plan. Unless otherwise agreed by the Parties, the importing Party shall provide the exporting Party with an audit or verification plan at least 30 days prior to the commencement of the audit or verification. 6. The importing Party shall provide the exporting Party the opportunity to comment on the draft audit or verification report. The importing Party shall provide a final report in writing to the exporting Party normally within two months from the date of receipt of those comments. 7. Each Party shall bear its own costs associated with such an audit or verification. Article 80 Notification and consultation 1. A Party shall notify the other Party without undue delay of: (a) a significant change to pest or disease status; (b) the emergence of a new animal disease; (c) a finding of epidemiological importance with respect to an animal disease; (d) a significant food safety issue identified by a Party; (e) any additional measures beyond the basic requirements of their respective SPS measures taken to control or eradicate animal disease or protect human health, and any changes in preventive policies, including vaccination policies; (f) on request, the results of a Party's official control and a report that concerns the results of the control carried out; and (g) any significant changes to the functions of a system or database. 2. If a Party has a significant concern with respect to food safety, plant health, or animal health, or an SPS measure that the other Party has proposed or implemented, that Party may request technical consultations with the other Party. The requested Party should respond to the request without undue delay. Each Party shall endeavour to provide the information necessary to avoid a disruption to trade and, as the case may be, to reach a mutually acceptable solution. 3. Consultations referred to in paragraph 2 may be held via telephone conference, videoconference, or any other means of communication mutually agreed on by the Parties. Article 81 Emergency measures 1. If the importing Party considers that there is a serious risk to human, animal or plant life and health, it may take without prior notification the necessary measures for the protection of human, animal or plant life and health. For consignments that are in transit between the Parties, the importing Party shall consider the most suitable and proportionate solution to avoid unnecessary disruptions to trade. 2. The Party taking the measures shall notify the other Party of an emergency SPS measure as soon as possible after its decision to implement the measure and no later than 24 hours after the decision has been taken. If a Party requests technical consultations to address the emergency SPS measure, the technical consultations must be held within 10 days of the notification of the emergency SPS measure. The Parties shall consider any information provided through the technical consultations. These consultations shall be carried out in order to avoid unnecessary disruptions to trade. The Parties may consider options for the facilitation of the implementation or the replacement of the measures. 3. The importing Party shall consider, in a timely manner, information that was provided by the exporting Party when it makes its decision with respect to consignments that, at the time of adoption of the emergency SPS measure, are being transported between the Parties, in order to avoid unnecessary disruptions to trade. 4. The importing Party shall ensure that any emergency measure taken on the grounds referred to in paragraph 1 of this Article is not maintained without scientific evidence or, in cases where scientific evidence is insufficient, is adopted in accordance with Article 5(7) of the SPS Agreement. Article 82 Multilateral international fora The Parties agree to cooperate in multilateral international fora on the development of international standards, guidelines and recommendations in the areas under the scope of this Chapter. Article 83 Implementation and competent authorities 1. For the purposes of the implementation of this Chapter, each Party shall take all of the following into account: (a) decisions of the WTO SPS Committee; (b) the work of the relevant international standard setting bodies; (c) any knowledge and past experience it has of trading with the exporting Party; and (d) information provided by the other Party. 2. The Parties shall, without delay, provide each other with a description of the competent authorities of the Parties for the implementation of this Chapter. The Parties shall notify each other of any significant change to these competent authorities. 3. Each Party shall ensure that its competent authorities have the necessary resources to effectively implement this Chapter. Article 84 Cooperation on animal welfare 1. The Parties recognise that animals are sentient beings. They also recognise the connection between improved welfare of animals and sustainable food production systems. 2. The Parties undertake to cooperate in international fora to promote the development of the best possible animal welfare practices and their implementation. In particular, the Parties shall cooperate to reinforce and broaden the scope of the OIE animal welfare standards, as well as their implementation, with a focus on farmed animals. 3. The Parties shall exchange information, expertise and experiences in the field of animal welfare, particularly related to breeding, holding, handling, transportation and slaughter of food-producing animals. 4. The Parties shall strengthen their cooperation on research in the area of animal welfare in relation to animal breeding and the treatment of animals on farms, during transport and at slaughter. Article 85 Cooperation on antimicrobial resistance 1. The Parties shall provide a framework for dialogue and cooperation with a view to strengthening the fight against the development of antimicrobial resistance. 2. The Parties recognise that antimicrobial resistance is a serious threat to human and animal health. Misuse of antimicrobials in animal production, including non-therapeutic use, can contribute to antimicrobial resistance that may represent a risk to human life. The Parties recognise that the nature of the threat requires a transnational and One Health approach. 3. With a view to combating antimicrobial resistance, the Parties shall endeavour to cooperate internationally with regional or multilateral work programmes to reduce the unnecessary use of antibiotics in animal production and to work towards the cessation of the use of antibiotics as growth promotors internationally to combat antimicrobial resistance in line with the One Health approach, and in compliance with the Global Action Plan. 4. The Parties shall collaborate in the development of international guidelines, standards, recommendations and actions in relevant international organisations aiming to promote the prudent and responsible use of antibiotics in animal husbandry and veterinary practices. 5. The dialogue referred to in paragraph 1 shall cover, inter alia: (a) collaboration to follow up existing and future guidelines, standards, recommendations and actions developed in relevant international organisations and existing and future initiatives and national plans aiming to promote the prudent and responsible use of antibiotics and relating to animal production and veterinary practices; (b) collaboration in the implementation of the recommendations of OIE, WHO and Codex, in particular CAC-RCP61/2005; (c) the exchange of information on good farming practices; (d) the promotion of research, innovation and development; (e) the promotion of multidisciplinary approaches to combat antimicrobial resistance, including the One Health approach of the WHO, OIE and Codex. Article 86 Sustainable food systems Each Party shall encourage its food safety, animal and plant health services to cooperate with their counterparts in the other Party with the aim of promoting sustainable food production methods and food systems. Article 87 Trade Specialised Committee on Sanitary and Phytosanitary Measures The Trade Specialised Committee on Sanitary and Phytosanitary Measures shall supervise the implementation and operation of this Chapter and have the following functions: (a) promptly clarifying and addressing, where possible, any issue raised by a Party relating to the development, adoption or application of sanitary and phytosanitary requirements, standards and recommendations under this Chapter or the SPS Agreement; (b) discussing ongoing processes on the development of new regulations; (c) discussing as expeditiously as possible concerns expressed by a Party with regard to the SPS import conditions and procedures applied by the other Party; (d) regularly reviewing the Parties' SPS measures, including certification requirements and border clearance processes, and their application, in order to facilitate trade between the Parties, in accordance with the principles, objectives and procedures set out in Article 5 of the SPS Agreement. Each Party shall identify any appropriate action it will take, including in relation to the frequency of identity and physical checks, taking into consideration the results of this review and based on the criteria laid down in Annex 10 of this Agreement; (e) exchanging views, information, and experiences with respect to the cooperation activities on protecting animal welfare and the fight against antimicrobial resistance carried out under Articles 84 and 85; (f) on request of a Party, considering what constitutes a significant change in the disease or pest situation referred to in Article 78(9); (g) adopting decisions to: (i) add definitions as referred to in Article 71; (ii) define the specific cases referred to in Article 74(2); (iii) define details for the procedures referred to in Article 78(1); (iv) establish other ways to support the explanations referred to in Article 78(5) and (7). CHAPTER 4 TECHNICAL BARRIERS TO TRADE Article 88 Objective The objective of this Chapter is to facilitate trade in goods between the Parties by preventing, identifying and eliminating unnecessary technical barriers to trade. Article 89 Scope 1. This Chapter applies to the preparation, adoption and application of all standards, technical regulations and conformity assessment procedures, which may affect trade in goods between the Parties. 2. This Chapter does not apply to: (a) purchasing specifications prepared by governmental bodies for production or consumption requirements of such bodies; or (b) SPS measures that fall within the scope of Chapter 3 of this Title. 3. The Annexes to this Chapter apply in addition to this Chapter in respect of products within the scope of those Annexes. Any provision in an Annex to this Chapter that an international standard or body or organisation is to be considered or recognised as relevant shall not prevent a standard developed by any other body or organisation from being considered to be a relevant international standard pursuant to Article 91(4) and (5). Article 90 Relationship with the TBT Agreement 1. Articles 2 to 9 of and Annexes 1 and 3 to the TBT Agreement are incorporated into and made part of this Agreement mutatis mutandis. 2. Terms referred to in this Chapter and in the Annexes to this Chapter shall have the same meaning as they have in the TBT Agreement. Article 91 Technical regulations 1. Each Party shall carry out impact assessments of planned technical regulations in accordance with its respective rules and procedures. The rules and procedures referred to in this paragraph and in paragraph 8 may provide for exceptions. 2. Each Party shall assess the available regulatory and non-regulatory alternatives to the proposed technical regulation that may fulfil the Party's legitimate objectives, in accordance with Article 2.2 of the TBT Agreement. 3. Each Party shall use relevant international standards as a basis for its technical regulations except when it can demonstrate that such international standards would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued. 4. International standards developed by the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the International Telecommunication Union (ITU) and the Codex Alimentarius Commission (Codex) shall be the relevant international standards within the meaning of Article 2, Article 5 and Annex 3 of the TBT Agreement. 5. A standard developed by other international organisations may also be considered a relevant international standard within the meaning of Article 2, Article 5 and Annex 3 of the TBT Agreement, provided that: (a) it has been developed by a standardising body which seeks to establish consensus either: (i) among national delegations of the participating WTO Members representing all the national standardising bodies in their territory that have adopted, or expect to adopt, standards on the subject matter to which the international standardisation activity relates, or, (ii) among governmental bodies of participating WTO Members; and (b) it has been developed in accordance with the Decision of the WTO Committee on Technical Barriers to Trade on Principles for the Development of International Standards, Guides and Recommendations with relation to Articles 2, 5, and Annex 3 of the TBT Agreement. (4) 6. Where a Party does not use international standards as a basis for a technical regulation, on request of the other Party, it shall identify any substantial deviation from the relevant international standard, explain the reasons why such standards were judged inappropriate or ineffective for the objective pursued, and provide the scientific or technical evidence on which that assessment was based. 7. Each Party shall review its technical regulations to increase the convergence of those technical regulations with relevant international standards, taking into account, inter alia, any new developments in the relevant international standards or any changes in the circumstances that have given rise to divergence from any relevant international standards. 8. In accordance with its respective rules and procedures and without prejudice to Title X of this Heading, when developing a major technical regulation which may have a significant effect on trade, each Party shall ensure that procedures exist that allow persons to express their opinion in a public consultation, except where urgent problems of safety, health, environment or national security arise or threaten to arise. Each Party shall allow persons of the other Party to participate in such consultations on terms that are no less favourable than those accorded to its own nationals, and shall make the results of those consultations public. Article 92 Standards 1. Each Party shall encourage the standardising bodies established within its territory, as well as the regional standardising bodies of which a Party or the standardising bodies established in its territory are members: (a) to participate, within the limits of their resources, in the preparation of international standards by relevant international standardising bodies; (b) to use relevant international standards as a basis for the standards they develop, except where such international standards would be ineffective or inappropriate, for example because of an insufficient level of protection, fundamental climatic or geographical factors or fundamental technological problems; (c) to avoid duplications of, or overlaps with, the work of international standardising bodies; (d) to review national and regional standards that are not based on relevant international standards at regular intervals, with a view to increasing the convergence of those standards with relevant international standards; (e) to cooperate with the relevant standardising bodies of the other Party in international standardisation activities, including through cooperation in the international standardising bodies or at regional level; (f) to foster bilateral cooperation with the standardising bodies of the other Party; and (g) to exchange information between standardising bodies. 2. The Parties shall exchange information on: (a) their respective use of standards in support of technical regulations; and (b) their respective standardisation processes, and the extent to which they use international, regional or sub-regional standards as a basis for their national standards. 3. Where standards are rendered mandatory in a draft technical regulation or conformity assessment procedure, through incorporation or reference, the transparency obligations set out in Article 94 and in Article 2 or 5 of the TBT Agreement shall apply. Article 93 Conformity assessment 1. Article 91 concerning the preparation, adoption and application of technical regulations shall also apply to conformity assessment procedures, mutatis mutandis. 2. Where a Party requires conformity assessment as a positive assurance that a product conforms with a technical regulation, it shall: (a) select conformity assessment procedures that are proportionate to the risks involved, as determined on the basis of a risk-assessment; (b) consider as proof of compliance with technical regulations the use of a supplier's declaration of conformity, i.e. a declaration of conformity issued by the manufacturer on the sole responsibility of the manufacturer without a mandatory third-party assessment, as assurance of conformity among the options for showing compliance with technical regulations; (c) where requested by the other Party, provide information on the criteria used to select the conformity assessment procedures for specific products. 3. Where a Party requires third party conformity assessment as a positive assurance that a product conforms with a technical regulation and it has not reserved this task to a government authority as specified in paragraph 4, it shall: (a) use accreditation, as appropriate, as a means to demonstrate technical competence to qualify conformity assessment bodies. Without prejudice to its right to establish requirements for conformity assessment bodies, each Party recognises the valuable role that accreditation operated with authority derived from government and on a non-commercial basis can play in the qualification of conformity assessment bodies; (b) use relevant international standards for accreditation and conformity assessment; (c) encourage accreditation bodies and conformity assessment bodies located within its territory to join any relevant functioning international agreements or arrangements for harmonisation or facilitation of acceptance of conformity assessment results; (d) if two or more conformity assessment bodies are authorised by a Party to carry out conformity assessment procedures required for placing a product on the market, ensure that economic operators have a choice amongst the conformity assessment bodies designated by the authorities of a Party for a particular product or set of products; (e) ensure that conformity assessment bodies are independent of manufacturers, importers and economic operators in general and that there are no conflicts of interest between accreditation bodies and conformity assessment bodies; (f) allow conformity assessment bodies to use subcontractors to perform testing or inspections in relation to the conformity assessment, including subcontractors located in the territory of the other Party, and may require subcontractors to meet the same requirements the conformity assessment body must meet to perform such testing or inspections itself; and (g) publish on a single website a list of the bodies that it has designated to perform such conformity assessment and the relevant information on the scope of designation of each such body. 4. Nothing in this Article shall preclude a Party from requiring that conformity assessment in relation to specific products is performed by its specified government authorities. If a Party requires that conformity assessment is performed by its specified government authorities, that Party shall: (a) limit the conformity assessment fees to the approximate cost of the services rendered and, at the request of an applicant for conformity assessment, explain how any fees it imposes for that conformity assessment are limited to the approximate cost of services rendered; and (b) make publicly available the conformity assessment fees. 5. Notwithstanding paragraphs 2 to 4, each Party shall accept a supplier's declaration of conformity as proof of compliance with its technical regulations in those product areas where it does so on the date of entry into force of this Agreement. 6. Each Party shall publish and maintain a list of the product areas referred to in paragraph 5 for information purposes, together with the references to the applicable technical regulations. 7. Notwithstanding paragraph 5, either Party may introduce requirements for the mandatory third party testing or certification of the product areas referred to in that paragraph, provided that such requirements are justified on grounds of legitimate objectives and are proportionate to the purpose of giving the importing Party adequate confidence that products conform with the applicable technical regulations or standards, taking account of the risks that non-conformity would create. 8. A Party proposing to introduce the conformity assessment procedures referred to in paragraph 7 shall notify the other Party at an early stage and shall take the comments of the other Party into account in devising any such conformity assessment procedures. Article 94 Transparency 1. Except where urgent problems of safety, health, environmental protection or national security arise or threaten to arise, each Party shall allow the other Party to provide written comments on notified proposed technical regulations and conformity assessment procedures within a period of at least 60 days from the date of the transmission of the notification of such regulations or procedures to the WTO Central Registry of Notifications. A Party shall give positive consideration to a reasonable request to extend that comment period. 2. Each Party shall provide the electronic version of the full notified text together with the notification. In the event that the notified text is not in one of the official WTO languages, the notifying Party shall provide a detailed and comprehensive description of the content of the measure in the WTO notification format. 3. If a Party receives written comments on its proposed technical regulation or conformity assessment procedure from the other Party, it shall: (a) if requested by the other Party, discuss the written comments with the participation of its competent regulatory authority, at a time when they can be taken into account; and (b) reply in writing to the comments no later than the date of publication of the technical regulation or conformity assessment procedure. 4. Each Party shall endeavour to publish on a website its responses to the comments it receives following the notification referred to in paragraph 1 no later than on the date of publication of the adopted technical regulation or conformity assessment procedure. 5. Each Party shall, where requested by the other Party, provide information regarding the objectives of, legal basis for and rationale for, any technical regulation or conformity assessment procedure that the Party has adopted or is proposing to adopt. 6. Each Party shall ensure that the technical regulations and conformity assessment procedures it has adopted are published on a website that is accessible free of charge. 7. Each Party shall provide information on the adoption and the entry into force of technical regulations or conformity assessment procedures and the adopted final texts through an addendum to the original notification to the WTO. 8. Each Party shall allow a reasonable interval between the publication of technical regulations and their entry into force, in order to allow time for the economic operators of the other Party to adapt. "Reasonable interval" means a period of at least six months, unless this would be ineffective in fulfilling the legitimate objectives pursued. 9. A Party shall give positive consideration to a reasonable request from the other Party received prior to the end of the comment period set out in paragraph 1 to extend the period of time between the adoption of the technical regulation and its entry into force, except where the delay would be ineffective in fulfilling the legitimate objectives pursued. 10. Each Party shall ensure that the enquiry point established in accordance with Article 10 of the TBT Agreement provides information and answers in one of the official WTO languages to reasonable enquiries from the other Party or from interested persons of the other Party regarding adopted technical regulations and conformity assessment procedures. Article 95 Marking and labelling 1. The technical regulations of a Party may include or exclusively address mandatory marking or labelling requirements. In such cases, the principles of Article 2.2 of the TBT Agreement apply to these technical regulations. 2. Where a Party requires mandatory marking or labelling of products, all of the following conditions shall apply: (a) it shall only require information which is relevant for consumers or users of the product or information that indicates that the product conforms to the mandatory technical requirements; (b) it shall not require any prior approval, registration or certification of the labels or markings of products, nor any fee disbursement, as a precondition for placing on its market products that otherwise comply with its mandatory technical requirements unless it is necessary in view of legitimate objectives; (c) where the Party requires the use of a unique identification number by economic operators, it shall issue such a number to the economic operators of the other Party without undue delay and on a non-discriminatory basis; (d) unless the information listed in point (i), (ii) or (iii) would be misleading, contradictory or confusing in relation to the information that the importing Party requires with respect to the goods, the importing Party shall permit: (i) information in other languages in addition to the language required in the importing Party of the goods; (ii) internationally-accepted nomenclatures, pictograms, symbols or graphics; and (iii) additional information to that required in the importing Party of the goods; (e) it shall accept that labelling, including supplementary labelling or corrections to labelling, take place in customs warehouses or other designated areas in the country of import as an alternative to labelling in the country of origin, unless such labelling is required to be carried out by approved persons for reasons of public health or safety; and (f) unless it considers that legitimate objectives may be undermined, it shall endeavour to accept the use of non-permanent or detachable labels, or marking or labelling in the accompanying documentation, rather than requiring labels or marking to be physically attached to the product. Article 96 Cooperation on market surveillance and non-food product safety and compliance 1. The Parties recognise the importance of cooperation on market surveillance, compliance and the safety of non-food products for the facilitation of trade and for the protection of consumers and other users, and the importance of building mutual trust based on shared information. 2. To guarantee the independent and impartial functioning of market surveillance, the Parties shall ensure: (a) the separation of market surveillance functions from conformity assessment functions; and (b) the absence of any interests that would affect the impartiality of market surveillance authorities in the performance of their control or supervision of economic operators. 3. The Parties shall cooperate and exchange information in the area of non-food product safety and compliance, which may include in particular the following: (a) market surveillance and enforcement activities and measures; (b) risk assessment methods and product testing; (c) coordinated product recalls or other similar actions; (d) scientific, technical and regulatory matters in order to improve non-food product safety and compliance; (e) emerging issues of significant health and safety relevance; (f) standardisation-related activities; (g) exchanges of officials. 4. The Partnership Council shall use its best endeavours to establish in Annex 16, as soon as possible and preferably within six months of entry into force of this Agreement, an arrangement for the regular exchange of information between the Rapid Alert System for non-food products (RAPEX), or its successor, and the database relating to market surveillance and product safety established under the General Product Safety Regulations 2005, or its successor, in relation to the safety of non-food products and related preventive, restrictive and corrective measures. The arrangement shall set out the modalities under which: (a) the Union is to provide the United Kingdom with selected information from its RAPEX alert system, or its successor, as referred to in Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, or its successor; (b) the United Kingdom is to provide the Union with selected information from its database relating to market surveillance and product safety established under the General Product Safety Regulations 2005, or its successor; and (c) the Parties are to inform each other of any follow-up actions and measures taken in response to the information exchanged. 5. The Partnership Council may establish in Annex 17 an arrangement on the regular exchange of information, including the exchange of information by electronic means, regarding measures taken on non-compliant non-food products, other than those covered by paragraph 4. 6. Each Party shall use the information obtained pursuant to paragraphs 3, 4 and 5 for the sole purpose of protecting consumers, health, safety or the environment. 7. Each Party shall treat the information obtained pursuant to paragraphs 3, 4 and 5 as confidential. 8. The arrangements referred to in paragraphs 4 and 5 shall specify the type of information to be exchanged, the modalities for the exchange and the application of confidentiality and personal data protection rules. The Partnership Council shall have the power to adopt decisions in order to determine or amend the arrangements set out in Annexes 16 and 17. 9. For the purposes of this Article, "market surveillance" means activities conducted and measures taken by market surveillance and enforcement authorities, including activities conducted and measures taken in cooperation with economic operators, on the basis of procedures of a Party to enable that Party to monitor or address safety of products and their compliance with the requirements set out in its laws and regulations. 10. Each Party shall ensure that any measure taken by its market surveillance or enforcement authorities to withdraw or recall from its market or to prohibit or restrict the making available on its market of a product imported from the territory of the other Party, for reasons related to non-compliance with the applicable legislation, is proportionate, states the exact grounds on which the measure is based and is communicated without delay to the relevant economic operator. Article 97 Technical discussions 1. If a Party considers that a draft or proposed technical regulation or conformity assessment procedure of the other Party might have a significant effect on trade between the Parties, it may request technical discussions on the matter. The request shall be made in writing to the other Party and shall identify: (a) the measure at issue; (b) the provisions of this Chapter or of an Annex to this Chapter to which the concerns relate; and (c) the reasons for the request, including a description of the requesting Party's concerns regarding the measure. 2. A Party shall deliver its request to the contact point of the other Party designated pursuant to Article 99. 3. At the request of either Party, the Parties shall meet to discuss the concerns raised in the request, in person or via videoconference or teleconference, within 60 days of the date of the request and shall endeavour to resolve the matter as expeditiously as possible. If a requesting Party believes that the matter is urgent, it may request that any meeting take place within a shorter time frame. In such cases, the responding Party shall give positive consideration to such a request. Article 98 Cooperation 1. The Parties shall cooperate in the field of technical regulations, standards and conformity assessment procedures, where it is in their mutual interest, and without prejudice to the autonomy of their own respective decision-making and legal orders. The Trade Specialised Committee on Technical Barriers to Trade may exchange views with respect to the cooperation activities carried out under this Article or the Annexes to this Chapter. 2. For the purposes of paragraph 1, the Parties shall seek to identify, develop and promote cooperation activities of mutual interest. These activities may in particular relate to: (a) the exchange of information, experience and data related to technical regulations, standards and conformity assessment procedures; (b) ensuring efficient interaction and cooperation of their respective regulatory authorities at international, regional or national level; (c) exchanging information, to the extent possible, about international agreements and arrangements regarding technical barriers to trade to which one or both Parties are party; and (d) establishment of or participation in trade facilitating initiatives. 3. For the purposes of this Article and the provisions on cooperation under the Annexes to this Chapter, the European Commission shall act on behalf of the Union. Article 99 Contact points 1. Upon the entry into force of this Agreement, each Party shall designate a contact point for the implementation of this Chapter and shall notify the other Party of the contact details for the contact point, including information regarding the relevant officials. The Parties shall promptly notify each other of any change of those contact details. 2. The contact point shall provide any information or explanation requested by the contact point of the other Party in relation to the implementation of this Chapter within a reasonable period of time and, if possible, within 60 days of the date of receipt of the request. Article 100 Trade Specialised Committee on Technical Barriers to Trade The Trade Specialised Committee on Technical Barriers to Trade shall supervise the implementation and operation of this Chapter and its Annexes and shall promptly clarify and address, where possible, any issue raised by a Party relating to the development, adoption or application of technical regulations, standards and conformity assessment procedures under this Chapter or the TBT Agreement. CHAPTER 5 CUSTOMS AND TRADE FACILITATION Article 101 Objective The objectives of this Chapter are: (a) to reinforce cooperation between the Parties in the area of customs and trade facilitation and to support or maintain, where relevant, appropriate levels of compatibility of their customs legislation and practices with a view to ensuring that relevant legislation and procedures, as well as the administrative capacity of the relevant administrations, fulfil the objectives of promoting trade facilitation while ensuring effective customs controls and effective enforcement of customs legislation and trade related laws and regulations, the proper protection of security and safety of citizens and the respect of prohibitions and restrictions and financial interests of the Parties; (b) to reinforce administrative cooperation between the Parties in the field of VAT and mutual assistance in claims related to taxes and duties; (c) to ensure that the legislation of each Party is non-discriminatory and that customs procedures are based upon the use of modern methods and effective controls to combat fraud and to promote legitimate trade; and (d) to ensure that legitimate public policy objectives, including in relation to security, safety and the fight against fraud are not compromised in any way. Article 102 Definitions For the purposes of this Chapter and Annex 18 and the Protocol on mutual administrative assistance in customs matters and the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties, the following definitions apply: (a) "Agreement on Pre-shipment Inspection" means the Agreement on Pre-shipment Inspection, contained in Annex 1A to the WTO Agreement; (b) "ATA and Istanbul Conventions" means the Customs Convention on the ATA Carnet for the Temporary Admission of Goods done in Brussels on 6 December 1961 and the Istanbul Convention on Temporary Admission done on 26 June 1990; (c) "Common Transit Convention" means the Convention of 20 May 1987 on a common transit procedure; (d) "Customs Data Model of the WCO" means the library of data components and electronic templates for the exchange of business data and compilation of international standards on data and information used in applying regulatory facilitation and controls in global trade, as published by the WCO Data Model Project Team from time to time; (e) "customs legislation" means any legal or regulatory provision applicable in the territory of either Party, governing the entry or import of goods, exit or export of goods, the transit of goods and the placing of goods under any other customs regime or procedure, including measures of prohibition, restriction and control; (f) "information" means any data, document, image, report, communication or authenticated copy, in any format, including in electronic format, whether or not processed or analysed; (g) "person" means any person as defined in point (l) of Article 512 (5); (h) "SAFE Framework" means the SAFE Framework of Standards to Secure and Facilitate Global Trade adopted at the June 2005 World Customs Organisation Session in Brussels and as updated from time to time; and (i) "WTO Trade Facilitation Agreement" means the Agreement on Trade Facilitation annexed to the Protocol Amending the WTO Agreement (decision of 27 November 2014). Article 103 Customs cooperation 1. The relevant authorities of the Parties shall cooperate on customs matters to support the objectives set out in Article 101, taking into account the resources of their respective authorities. For the purpose of this Title, the Convention of 20 May 1987 on the Simplification of Formalities in Trade in Goods applies. 2. The Parties shall develop cooperation, including in the following areas: (a) exchanging information concerning customs legislation, the implementation of customs legislation and customs procedures; particularly in the following areas: (i) the simplification and modernisation of customs procedures; (ii) the facilitation of transit movements and transhipment; (iii) relations with the business community; and (iv) supply chain security and risk management; (b) working together on the customs-related aspects of securing and facilitating the international trade supply chain in accordance with the SAFE Framework; (c) considering developing joint initiatives relating to import, export and other customs procedures including technical assistance, as well as towards ensuring an effective service to the business community; (d) strengthening their cooperation in the field of customs in international organisations such as the WTO and the WCO, and exchanging information or holding discussions with a view to establishing where possible common positions in those international organisations and in UNCTAD, UNECE; (e) endeavouring to harmonise their data requirements for import, export and other customs procedures by implementing common standards and data elements in accordance with the Customs Data Model of the WCO; (f) strengthening their cooperation on risk management techniques, including sharing best practices, and, where appropriate, risk information and control results. Where relevant and appropriate, the Parties may also consider mutual recognition of risk management techniques, risk standards and controls and customs security measures; the Parties may also consider, where relevant and appropriate, the development of compatible risk criteria and standards, control measures and priority control areas; (g) establishing mutual recognition of Authorised Economic Operator programmes to secure and facilitate trade; (h) fostering cooperation between customs and other government authorities or agencies in relation to Authorised Economic Operator programmes, which may be achieved, inter alia, by agreeing on the highest standards, facilitating access to benefits and minimising unnecessary duplication; (i) enforcing intellectual property rights by customs authorities, including exchanging information and best practices in customs operations focusing in particular on intellectual property rights enforcement; (j) maintaining compatible customs procedures, where appropriate and practicable to do so, including the application of a single administrative document for customs declaration; and (k) exchanging, where relevant and appropriate and under arrangements to be agreed, certain categories of customs-related information between the customs authorities of the Parties through structured and recurrent communication, for the purposes of improving risk management and the effectiveness of customs controls, targeting goods at risk in terms of revenue collection or safety and security, and facilitating legitimate trade; such exchanges may include export and import declaration data on trade between the Parties, with the possibility of exploring, through pilot initiatives, the development of interoperable mechanisms to avoid duplication in the submission of such information. Exchanges under this point shall be without prejudice to exchanges of information that may take place between the Parties pursuant to the Protocol on mutual administrative assistance in customs matters. 3. Without prejudice to other forms of cooperation envisaged in this Agreement, the customs authorities of the Parties shall provide each other with mutual administrative assistance in the matters covered by this Chapter in accordance with the Protocol on mutual administrative assistance in customs matters. 4. Any exchange of information between the Parties under this Chapter shall be subject to the confidentiality and protection of information set out in Article 12 of the Protocol on mutual administrative assistance in customs matters, mutatis mutandis, as well as to any confidentiality requirements set out in the legislation of the Parties. Article 104 Customs and other trade related legislation and procedures 1. Each Party shall ensure that its customs provisions and procedures: (a) are consistent with international instruments and standards applicable in the area of customs and trade, including the WTO Trade Facilitation Agreement, the substantive elements of the Revised Kyoto Convention on the Simplification and Harmonisation of Customs Procedures, the International Convention on the Harmonised Commodity Description and Coding System, as well as the SAFE Framework and the Customs Data Model of the WCO; (b) provide the protection and facilitation of legitimate trade taking into account the evolution of trade practices through effective enforcement including in case of breaches of its laws and regulations, duty evasion and smuggling and through ensuring compliance with legislative requirements; (c) are based on legislation that is proportionate and non-discriminatory, avoids unnecessary burdens on economic operators, provides for further facilitation for operators with high levels of compliance including favourable treatment with respect to customs controls prior to the release of goods, and ensures safeguards against fraud and illicit or damageable activities while ensuring a high level of protection of security and safety of citizens and the respect of prohibitions and restrictions and financial interests of the Parties; and (d) contain rules that ensure that any penalty imposed for breaches of customs regulations or procedural requirements is proportionate and non-discriminatory and that the imposition of such penalties does not result in unjustified delays. Each Party should periodically review its legislation and customs procedures. Customs procedures should also be applied in a manner that is predictable, consistent and transparent. 2. In order to improve working methods and to ensure non-discrimination, transparency, efficiency, integrity and the accountability of operations, each Party shall: (a) simplify and review requirements and formalities wherever possible with a view to ensuring the rapid release and clearance of goods; (b) work towards the further simplification and standardisation of the data and documentation required by customs and other agencies; and (c) promote coordination between all border agencies, both internally and across borders, to facilitate border-crossing processes and enhance control, taking into account joint border controls where feasible and appropriate. Article 105 Release of goods 1. Each Party shall adopt or maintain customs procedures that: (a) provide for the prompt release of goods within a period that is no longer than necessary to ensure compliance with its laws and regulations; (b) provide for advance electronic submission and processing of documentation and any other required information prior to the arrival of the goods, to enable the release of goods promptly upon arrival if no risk has been identified through risk analysis or if no random checks or other checks are to be performed; (c) provide for the possibility, where appropriate and if the necessary conditions are satisfied, of releasing goods for free circulation at the first point of arrival; and (d) allow for the release of goods prior to the final determination of customs duties, taxes, fees and charges, if such a determination is not done prior to, or upon arrival, or as rapidly as possible after arrival and provided that all other regulatory requirements have been met. 2. As a condition for such release, each Party may require a guarantee for any amount not yet determined in the form of a surety, a deposit or another appropriate instrument provided for in its laws and regulations. Such guarantee shall not be greater than the amount the Party requires to ensure payment of customs duties, taxes, fees and charges ultimately due for the goods covered by the guarantee. The guarantee shall be discharged when it is no longer required. 3. The Parties shall ensure that the customs and other authorities responsible for border controls and procedures dealing with importation, exportation and transit of goods cooperate with one another and coordinate their activities in order to facilitate trade and expedite the release of goods. Article 106 Simplified customs procedures 1. Each Party shall work towards simplification of its requirements and formalities for customs procedures in order to reduce the time and costs thereof for traders or operators, including small and medium-sized enterprises. 2. Each Party shall adopt or maintain measures allowing traders or operators fulfilling criteria specified in its laws and regulations to benefit from further simplification of customs procedures. Such measures may include inter alia: (a) customs declarations containing a reduced set of data or supporting documents; (b) periodical customs declarations for the determination and payment of customs duties and taxes covering multiple imports within a given period after the release of those imported goods; (c) self-assessment of and the deferred payment of customs duties and taxes until after the release of those imported goods; and (d) the use of a guarantee with a reduced amount or a waiver from the obligation to provide a guarantee. 3. Where a Party chooses to adopt one of these measures, it will offer, where considered appropriate and practicable by that Party and in accordance with its laws and regulations, these simplifications to all traders who meet the relevant criteria. Article 107 Transit and transhipment 1. For the purposes of Article 20, the Common Transit Convention shall apply. 2. Each Party shall ensure the facilitation and effective control of transhipment operations and transit movements through their respective territories. 3. Each Party shall promote and implement regional transit arrangements with a view to facilitating trade in compliance with the Common Transit Convention. 4. Each Party shall ensure cooperation and coordination between all concerned authorities and agencies in their respective territories in order to facilitate traffic in transit. 5. Each Party shall allow goods intended for import to be moved within its territory under customs control from a customs office of entry to another customs office in its territory from where the goods would be released or cleared. Article 108 Risk management 1. Each Party shall adopt or maintain a risk management system for customs controls with a view to reducing the likelihood and the impact of an event which would prevent the correct application of customs legislation, compromise the financial interest of the Parties or pose a threat to the security and safety of the Parties and their residents, to human, animal or plant health, to the environment or to consumers. 2. Customs controls, other than random checks, shall primarily be based on risk analysis using electronic data-processing techniques. 3. Each Party shall design and apply risk management in such a manner as to avoid arbitrary or unjustifiable discrimination, or disguised restrictions to international trade. 4. Each Party shall concentrate customs controls and other relevant border controls on high-risk consignments and shall expedite the release of low-risk consignments. Each Party may also select consignments for such controls on a random basis as part of its risk management. 5. Each Party shall base risk management on the assessment of risk through appropriate selectivity criteria. Article 109 Post-clearance audit 1. With a view to expediting the release of goods, each Party shall adopt or maintain post-clearance audit to ensure compliance with customs and other related laws and regulations. 2. Each Party shall select persons and consignments for post-clearance audits in a risk-based manner, which may include using appropriate selectivity criteria. Each Party shall conduct post-clearance audits in a transparent manner. Where a person is involved in the audit process and conclusive results have been achieved, the Party shall notify the person whose record is audited of the results, the person's rights and obligations and the reasons for the results, without delay. 3. The information obtained in post-clearance audits may be used in further administrative or judicial proceedings. 4. The Parties shall, wherever practicable, use the results of post-clearance audit for risk management purposes. Article 110 Authorised Economic Operators 1. Each Party shall maintain a partnership programme for operators who meet the specified criteria in Annex 18. 2. The Parties shall recognise their respective programmes for Authorised Economic Operators in accordance with Annex 18. Article 111 Publication and availability of information 1. Each Party shall ensure that its customs legislation and other trade-related laws and regulations, as well as its general administrative procedures and relevant information of general application that relate to trade, are published and readily available to any interested person in an easily accessible manner, including, as appropriate, through the Internet. 2. Each Party shall promptly publish new legislation and general procedures related to customs and trade facilitation issues as early as possible prior to the entry into force of any such legislation or procedures, and shall promptly publish any changes to and interpretations of such legislation and procedures. Such publication shall include: (a) relevant notices of an administrative nature; (b) importation, exportation and transit procedures (including port, airport, and other entry-point procedures) and required forms and documents; (c) applied rates of duty and taxes of any kind imposed on or in connection with importation or exportation; (d) fees and charges imposed by or for governmental agencies on or in connection with importation, exportation or transit; (e) rules for the classification or valuation of products for customs purposes; (f) laws, regulations and administrative rulings of general application relating to rules of origin; (g) import, export or transit restrictions or prohibitions; (h) penalty provisions against breaches of import, export or transit formalities; (i) appeal procedures; (j) agreements or parts thereof with any country or countries relating to importation, exportation or transit; (k) procedures relating to the administration of tariff quotas; (l) hours of operation and operating procedures for customs offices at ports and border crossing points; and (m) points of contact for information enquiries. 3. Each Party shall ensure there is a reasonable time period between the publication of new or amended legislation, procedures and fees or charges and their entry into force. 4. Each Party shall make the following available through the internet: (a) a description of its importation, exportation and transit procedures, including appeal procedures, informing of the practical steps needed to import and export, and for transit; (b) the forms and documents required for importation into, exportation from, or transit through the territory of that Party; and (c) contact information regarding enquiry points. Each party shall ensure that the descriptions, forms, documents and information referred to in points (a), (b) and (c) of the first subparagraph are kept up to date. 5. Each Party shall establish or maintain one or more enquiry points to answer enquiries of governments, traders and other interested parties regarding customs and other trade-related matters within a reasonable time. The Parties shall not require the payment of a fee for answering enquiries. Article 112 Advance rulings 1. Each Party, through its customs authorities, shall issue advance rulings upon application by economic operators setting forth the treatment to be accorded to the goods concerned. Such rulings shall be issued in writing or in electronic format in a time bound manner and shall contain all necessary information in accordance with the legislation of the issuing Party. 2. Advance rulings shall be valid for a period of at least three years from the starting date of their validity unless the ruling no longer conforms to the law or the facts or circumstances supporting the original ruling have changed. 3. A Party may refuse to issue an advance ruling if the question raised in the application is the subject of an administrative or judicial review, or if the application does not relate to any intended use of the advance ruling or any intended use of a customs procedure. If a Party declines to issue an advance ruling, it shall promptly notify the applicant in writing, setting out the relevant facts and the basis for its decision. 4. Each Party shall publish, at least: (a) the requirements for applying for an advance ruling, including the information to be provided and the format; (b) the time period by which it will issue an advance ruling; and (c) the length of time for which the advance ruling is valid. 5. If a Party revokes, modifies, invalidates or annuls an advance ruling, it shall provide written notice to the applicant setting out the relevant facts and the basis for its decision. A Party shall only revoke, modify, invalidate or annul an advance ruling with retroactive effect if the ruling was based on incomplete, incorrect, false or misleading information. 6. An advance ruling issued by a Party shall be binding on that Party in respect of the applicant that sought it. The Party may provide that the advance ruling is binding on the applicant. 7. Each Party shall provide, at the written request of the holder, a review of an advance ruling or of a decision to revoke, modify or invalidate an advance ruling. 8. Each Party shall make publicly available information on advance rulings, taking into account the need to protect personal and commercially confidential information. 9. Advance rulings shall be issued with regard to: (a) the tariff classification of goods; (b) the origin of goods; and (c) any other matter the Parties may agree upon. Article 113 Customs brokers The customs provisions and procedures of a Party shall not require the mandatory use of customs brokers or other agents. Each Party shall publish its measures on the use of customs brokers. Each Party shall apply transparent, non-discriminatory and proportionate rules if and when licensing customs brokers. Article 114 Pre-shipment inspections A Party shall not require the mandatory use of pre-shipment inspections as defined in the WTO Agreement on Pre-shipment Inspection, or any other inspection activity performed at destination, by private companies, before customs clearance. Article 115 Review and appeal 1. Each Party shall provide effective, prompt, non-discriminatory and easily accessible procedures that guarantee the right of appeal against administrative actions, rulings and decisions of customs or other competent authorities that affect the import or export of goods or goods in transit. 2. The procedures referred to in paragraph 1 shall include: (a) an administrative appeal to or review by an administrative authority higher than or independent of the official or office that issued the decision; and (b) a judicial appeal or review of the decision. 3. Each Party shall ensure that, in cases where the decision on appeal or review under point (a) of paragraph 2 is not given within the time period provided for in its laws and regulations or is not given without undue delay, the petitioner has the right to further administrative or judicial appeal or review or any other recourse to judicial authority in accordance with that Party's laws and regulations. 4. Each Party shall ensure that the petitioner is provided with the reasons for the administrative decision so as to enable the petitioner to have recourse to appeal or review procedures where necessary. Article 116 Relations with the business community 1. Each Party shall hold timely and regular consultations with trade representatives on legislative proposals and general procedures related to customs and trade facilitation issues. To that end, appropriate consultation between administrations and the business community shall be maintained by each Party. 2. Each Party shall ensure that its customs and related requirements and procedures continue to meet the needs of the trading community, follow best practices, and restrict trade as little as possible. Article 117 Temporary admission 1. For the purposes of this Article, "temporary admission" means the customs procedure under which certain goods, including means of transport, can be brought into a customs territory with conditional relief from the payment of import duties and taxes and without the application of import prohibitions or restrictions of an economic character, on the condition that the goods are imported for a specific purpose and are intended for re-exportation within a specified period without having undergone any change except normal depreciation due to the use made of those goods. 2. Each Party shall grant temporary admission, with total conditional relief from import duties and taxes and without application of import restrictions or prohibitions of economic character, as provided for in its laws and regulations, to the following types of goods: (a) goods for display or use at exhibitions, fairs, meetings or similar events (goods intended for display or demonstration at an event; goods intended for use in connection with the display of foreign products at an event; equipment including interpretation equipment, sound and image recording apparatus and films of an educational, scientific or cultural character intended for use at international meetings, conferences or congresses); products obtained incidentally during the event from temporarily imported goods, as a result of the demonstration of displayed machinery or apparatus; (b) professional equipment (equipment for the press, for sound or television broadcasting which is necessary for representatives of the press, of broadcasting or television organisations visiting the territory of another country for purposes of reporting, in order to transmit or record material for specified programmes; cinematographic equipment necessary for a person visiting the territory of another country in order to make a specified film or films; any other equipment necessary for the exercise of the calling, trade or profession of a person visiting the territory of another country to perform a specified task, insofar as it is not to be used for the industrial manufacture or packaging of goods or (except in the case of hand tools) for the exploitation of natural resources, for the construction, repair or maintenance of buildings or for earth moving and like projects; ancillary apparatus for the equipment mentioned above, and accessories therefor); component parts imported for repair of professional equipment temporarily admitted; (c) goods imported in connection with a commercial operation but whose importation does not in itself constitute a commercial operation (packings which are imported filled for re-exportation empty or filled, or are imported empty for re-exportation filled; containers, whether or not filled with goods, and accessories and equipment for temporarily admitted containers, which are either imported with a container to be re-exported separately or with another container, or are imported separately to be re-exported with a container and component parts intended for the repair of containers granted temporary admission; pallets; samples; advertising films; other goods imported in connection with a commercial operation); (d) goods imported in connection with a manufacturing operation (matrices, blocks, plates, moulds, drawings, plans, models and other similar articles; measuring, controlling and checking instruments and other similar articles; special tools and instruments, imported for use during a manufacturing process); replacement means of production (instruments, apparatus and machines made available to a customer by a supplier or repairer, pending the delivery or repair of similar goods); (e) goods imported exclusively for educational, scientific or cultural purposes (scientific equipment, pedagogic material, welfare material for seafarers, and any other goods imported in connection with educational, scientific or cultural activities); spare parts for scientific equipment and pedagogic material which has been granted temporary admission; tools specially designed for the maintenance, checking, gauging or repair of such equipment; (f) personal effects (all articles, new or used, which a traveller may reasonably require for his or her personal use during the journey, taking into account all the circumstances of the journey, but excluding any goods imported for commercial purposes); goods imported for sports purposes (sports requisites and other articles for use by travellers in sports contests or demonstrations or for training in the territory of temporary admission); (g) tourist publicity material (goods imported for the purpose of encouraging the public to visit another foreign country, in particular in order to attend cultural, religious, touristic, sporting or professional meetings or demonstrations held there); (h) goods imported for humanitarian purposes (medical, surgical and laboratory equipment and relief consignments, such as vehicles and other means of transport, blankets, tents, prefabricated houses or other goods of prime necessity, forwarded as aid to those affected by natural disaster and similar catastrophes); and (i) animals imported for specific purposes (dressage, training, breeding, shoeing or weighing, veterinary treatment, testing (for example, with a view to purchase), participation in shows, exhibitions, contests, competitions or demonstrations, entertainment (circus animals, etc.), touring (including pet animals of travellers), exercise of function (police dogs or horses; detector dogs, dogs for the blind, etc.), rescue operations, transhumance or grazing, performance of work or transport, medical purposes (delivery of snake poison, etc.). 3. Each Party shall, for the temporary admission of the goods referred to in paragraph 2 and regardless of their origin, accept a carnet as prescribed for the purposes of the ATA and Istanbul Conventions issued in the other Party, endorsed there and guaranteed by an association forming part of the international guarantee chain, certified by the competent authorities and valid in the customs territory of the importing Party. Article 118 Single window Each Party shall endeavour to establish a single window that enables traders to submit documentation or data required for importation, exportation, or transit of goods through a single entry point to the participating authorities or agencies. Article 119 Facilitation of roll-on, roll-off traffic 1. In recognition of the high volume of sea-crossings and, in particular, the high volume of roll on, roll off traffic between their respective customs territories, the Parties agree to cooperate in order to facilitate such traffic as well as other alternative modes of traffic. 2. The Parties acknowledge: (a) the right of each Party to adopt trade facilitating customs formalities and procedures for traffic between the Parties within their respective legal frameworks; and (b) the right of ports, port authorities and operators to act, within the legal orders of their respective Parties, in accordance with their rules and their operating and business models. 3. To this effect the Parties: (a) shall adopt or maintain procedures allowing for the submission of import documentation and other required information, including manifests, in order to begin processing prior to the arrival of goods with a view to expediting the release of goods upon arrival; and (b) undertake to facilitate the use by operators of the transit procedure, including simplifications of the transit procedure as provided for under the Common Transit Convention. 4. The Parties agree to encourage cooperation between their respective customs authorities on bilateral sea-crossing routes, and to exchange information on the functioning of ports handling traffic between them and on the applicable rules and procedures. They will make public, and promote knowledge by operators of, information on the measures they have in place and the processes established by ports to facilitate such traffic. Article 120 Administrative cooperation in VAT and mutual assistance for recovery of taxes and duties The competent authorities of the Parties shall cooperate with each other to ensure compliance with VAT legislation and in recovering claims relating to taxes and duties in accordance with the Protocol on administrative cooperation and combating fraud in the field of value added tax and on mutual assistance for the recovery of claims relating to taxes and duties. Article 121 Trade Specialised Committee on Customs Cooperation and Rules of Origin 1. The Trade Specialised Committee on Customs Cooperation and Rules of Origin shall: (a) hold regular consultations; and (b) in relation to the review of the provisions of Annex 18: (i) jointly validate programme members to identify strengths and weaknesses in implementing Annex 18; and (ii) exchange views on data to be shared and treatment of operators. 2. The Trade Specialised Committee on Customs Cooperation and Rules of Origin may adopt decisions or recommendations: (a) on the exchange of customs-related information, on mutual recognition of risk management techniques, risk standards and controls, customs security measures, on advanced rulings, on common approaches to customs valuation and on other issues related to the implementation of this Chapter; (b) on the arrangements relating to the automatic exchange of information as referred to in Article 10 of the Protocol on mutual administrative assistance in customs matters, and on other issues relating to the implementation of that Protocol; (c) on any issues relating to the implementation of Annex 18; and (d) on the procedures for the consultation established in Article 63 and on any technical or administrative matters relating to the implementation of Chapter 2 of this Title, including on interpretative notes aimed at ensuring the uniform administration of the rules of origin. Article 122 Amendments 1. The Partnership Council may amend: (a) Annex 18, the Protocol on mutual administrative assistance in customs matters and the list of goods set out in Article 117(2); and (b) the Protocol on administrative cooperation and combating fraud in the field of value added tax and on mutual assistance for the recovery of claims relating to taxes and duties. 2. The Trade Specialised Committee on Administrative Cooperation in VAT and Recovery of Taxes and Duties may amend the value referred to in Article 33(4) of the Protocol on administrative cooperation and combating fraud in the field of value added tax and on mutual assistance for the recovery of claims relating to taxes and duties. TITLE II SERVICES AND INVESTMENT CHAPTER 1 GENERAL PROVISIONS Article 123 Objective and scope 1. The Parties affirm their commitment to establish a favourable climate for the development of trade and investment between them. 2. The Parties reaffirm the right to regulate within their territories to achieve legitimate policy objectives, such as: the protection of public health; social services; public education; safety; the environment, including climate change; public morals; social or consumer protection; privacy and data protection or the promotion and protection of cultural diversity. 3. This Title does not apply to measures affecting natural persons of a Party seeking access to the employment market of the other Party or to measures regarding nationality, citizenship, residence or employment on a permanent basis. 4. This Title shall not prevent a Party from applying measures to regulate the entry of natural persons into, or their temporary stay in, its territory, including those measures necessary to protect the integrity of its borders and to ensure the orderly movement of natural persons across them, provided that such measures are not applied in such a manner as to nullify or impair the benefits accruing to the other Party under the terms of this Title. The sole fact of requiring a visa for natural persons of certain countries and not for those of others shall not be regarded as nullifying or impairing benefits under this Title. 5. This Title does not apply to: (a) air services or related services in support of air services (6), other than: (i) aircraft repair and maintenance services; (ii) computer reservation system services; (iii) ground handling services; (iv) the following services provided using a manned aircraft, subject to compliance with the Parties' respective laws and regulations governing the admission of aircrafts to, departure from and operation within, their territory: aerial fire-fighting; flight training; spraying; surveying; mapping; photography; and other airborne agricultural, industrial and inspection services; and (v) the selling and marketing of air transport services; (b) audio-visual services; (c) national maritime cabotage (7); and (d) inland waterways transport. 6. This Title does not apply to any measure of a Party with respect to public procurement of a good or service purchased for governmental purposes, and not with a view to commercial resale or with a view to use in the supply of a good or service for commercial sale, whether or not that procurement is "covered procurement" within the meaning of Article 277. 7. Except for Article 132, this Title does not apply to subsidies or grants provided by the Parties, including government-supported loans, guarantees and insurance. Article 124 Definitions For the purposes of this Title, the following definitions apply: (a) "activities performed in the exercise of governmental authority" means activities which are performed, including services which are supplied, neither on a commercial basis nor in competition with one or more economic operators; (8) (b) "aircraft repair and maintenance services" means such activities when undertaken on an aircraft or a part thereof while it is withdrawn from service and does not include so-called line maintenance; (c) "computer reservation system services" means services provided by computerised systems that contain information about air carriers' schedules, availability, fares and fare rules, through which reservations can be made or tickets may be issued; (d) "covered enterprise" means an enterprise in the territory of a Party established in accordance with point (h) by an investor of the other Party, in accordance with the applicable law, existing on the date of entry into force of this Agreement or established thereafter; (e) "cross-border trade in services" means the supply of a service: (i) from the territory of a Party into the territory of the other Party; or (ii) in the territory of a Party to the service consumer of the other Party; (f) "economic activity" means any activity of an industrial, commercial or professional character or activities of craftsmen, including the supply of services, except for activities performed in the exercise of governmental authority; (g) "enterprise" means a legal person or a branch or a representative office of a legal person; (h) "establishment" means the setting up or the acquisition of a legal person, including through capital participation, or the creation of a branch or representative office in the territory of a Party, with a view to creating or maintaining lasting economic links; (i) "ground handling services" means the supply at an airport, on a fee or contract basis, of the following services: airline representation, administration and supervision; passenger handling; baggage handling; ramp services; catering; air cargo and mail handling; fuelling of an aircraft; aircraft servicing and cleaning; surface transport; and flight operations, crew administration and flight planning; ground handling services do not include: self-handling; security; aircraft repair and maintenance; or management or operation of essential centralised airport infrastructure, such as de-icing facilities, fuel distribution systems, baggage handling systems and fixed intra airport transport systems; (j) "investor of a Party" means a natural or legal person of a Party that seeks to establish, is establishing or has established an enterprise in accordance with point (h) in the territory of the other Party; (k) "legal person of a Party" (9) means: (i) for the Union: (A) a legal person constituted or organised under the law of the Union or at least one of its Member States and engaged, in the territory of the Union, in substantive business operations, understood by the Union, in line with its notification of the Treaty establishing the European Community to the WTO (WT/REG39/1), as equivalent to the concept of "effective and continuous link" with the economy of a Member State enshrined in Article 54 of the Treaty on the Functioning of the European Union (TFEU); and (B) shipping companies established outside the Union, and controlled by natural persons of a Member State, whose vessels are registered in, and fly the flag of, a Member State; (ii) for the United Kingdom: (A) a legal person constituted or organised under the law of the United Kingdom and engaged in substantive business operations in the territory of the United Kingdom; and (B) shipping companies established outside the United Kingdom and controlled by natural persons of the United Kingdom, whose vessels are registered in, and fly the flag of, the United Kingdom; (l) "operation" means the conduct, management, maintenance, use, enjoyment, or sale or other form of disposal of an enterprise; (m) "professional qualifications" means qualifications attested by evidence of formal qualification, professional experience, or other attestation of competence; (n) "selling and marketing of air transport services" means opportunities for the air carrier concerned to sell and market freely its air transport services including all aspects of marketing such as market research, advertising and distribution, but not including the pricing of air transport services nor the applicable conditions; (o) "service" means any service in any sector except services supplied in the exercise of governmental authority; (p) "services supplied in the exercise of governmental authority" means any service which is supplied neither on a commercial basis, nor in competition with one or more service suppliers; (q) "service supplier" means any natural or legal person that seeks to supply or supplies a service; (r) "service supplier of a Party" means a natural or legal person of a Party that seeks to supply or supplies a service. Article 125 Denial of benefits 1. A Party may deny the benefits of this Title and Title IV of this Heading to an investor or service supplier of the other Party, or to a covered enterprise, if the denying Party adopts or maintains measures related to the maintenance of international peace and security, including the protection of human rights, which: (a) prohibit transactions with that investor, service supplier or covered enterprise; or (b) would be violated or circumvented if the benefits of this Title and Title IV of this Heading were accorded to that investor, service supplier or covered enterprise, including where the measures prohibit transactions with a natural or legal person which owns or controls any of them. 2. For greater certainty, paragraph 1 is applicable to Title IV of this Heading to the extent that it relates to services or investment with respect to which a Party has denied the benefits of this Title. Article 126 Review 1. With a view to introducing possible improvements to the provisions of this Title, and consistent with their commitments under international agreements, the Parties shall review their legal framework relating to trade in services and investment, including this Agreement, in accordance with Article 776. 2. The Parties shall endeavour, where appropriate, to review the non-conforming measures and reservations set out in Annexes 19, 20, 21 and 22 and the activities for short term business visitors set out in Annex 21, with a view to agreeing to possible improvements in their mutual interest. 3. This Article shall not apply with respect to financial services. CHAPTER 2 INVESTMENT LIBERALISATION Article 127 Scope This Chapter applies to measures of a Party affecting the establishment of an enterprise to perform economic activities and the operation of such an enterprise by: (a) investors of the other Party; (b) covered enterprises; and (c) for the purposes of Article 132, any enterprise in the territory of the Party which adopts or maintains the measure. Article 128 Market access A Party shall not adopt or maintain, with regard to establishment of an enterprise by an investor of the other Party or by a covered enterprise, or operation of a covered enterprise, either on the basis of its entire territory or on the basis of a territorial sub-division, measures that: (a) impose limitations on: (i) the number of enterprises that may carry out a specific economic activity, whether in the form of numerical quotas, monopolies, exclusive rights or the requirement of an economic needs test; (ii) the total value of transactions or assets in the form of numerical quotas or the requirement of an economic needs test; (iii) the total number of operations or on the total quantity of output expressed in terms of designated numerical units in the form of quotas or the requirement of an economic needs test; (10) (11) (iv) the participation of foreign capital in terms of maximum percentage limit on foreign shareholding or the total value of individual or aggregate foreign investment; or (v) the total number of natural persons that may be employed in a particular sector or that an enterprise may employ and who are necessary for, and directly related to, the performance of an economic activity, in the form of numerical quotas or the requirement of an economic needs test; or (b) restrict or require specific types of legal entity or joint venture through which an investor of the other Party may perform an economic activity. Article 129 National treatment 1. Each Party shall accord to investors of the other Party and to covered enterprises treatment no less favourable than that it accords, in like situations, to its own investors and to their enterprises, with respect to their establishment and operation in its territory. 2. The treatment accorded by a Party under paragraph 1 means: (a) with respect to a regional or local level of government of the United Kingdom, treatment no less favourable than the most favourable treatment accorded, in like situations, by that level of government to investors of the United Kingdom and to their enterprises in its territory; and (b) with respect to a government of, or in, a Member State, treatment no less favourable than the most favourable treatment accorded, in like situations, by that government to investors of that Member State and to their enterprises in its territory. Article 130 Most-favoured-nation-treatment 1. Each Party shall accord to investors of the other Party and to covered enterprises treatment no less favourable than that it accords, in like situations, to investors of a third country and to their enterprises, with respect to establishment in its territory. 2. Each Party shall accord to investors of the other Party and to covered enterprises treatment no less favourable than that it accords, in like situations, to investors of a third country and to their enterprises, with respect to operation in its territory. 3. Paragraphs 1 and 2 shall not be construed as obliging a Party to extend to investors of the other Party or to covered enterprises the benefit of any treatment resulting from: (a) an international agreement for the avoidance of double taxation or other international agreement or arrangement relating wholly or mainly to taxation; or (b) measures providing for recognition, including the recognition of the standards or criteria for the authorisation, licencing, or certification of a natural person or enterprise to carry out an economic activity, or the recognition of prudential measures as referred to in paragraph 3 of the GATS Annex on Financial Services. 4. For greater certainty, the "treatment" referred to in paragraphs 1 and 2 does not include investor-to-state dispute settlement procedures provided for in other international agreements. 5. For greater certainty, the existence of substantive provisions in other international agreements concluded by a Party with a third country, or the mere formal transposition of those provisions into domestic law to the extent that it is necessary in order to incorporate them into the domestic legal order, do not in themselves constitute the "treatment" referred to in paragraphs 1 and 2. Measures of a Party pursuant to those provisions may constitute such treatment and thus give rise to a breach of this Article. Article 131 Senior management and boards of directors A Party shall not require a covered enterprise to appoint individuals of any particular nationality as executives, managers or members of boards of directors. Article 132 Performance requirements 1. A Party shall not impose or enforce any requirement, or enforce any commitment or undertaking, in connection with the establishment or operation of any enterprise in its territory: (a) to export a given level or percentage of goods or services; (b) to achieve a given level or percentage of domestic content; (c) to purchase, use or accord a preference to goods produced or services provided in its territory or to purchase goods or services from natural or legal persons or any other entities in its territory; (d) to relate in any way the volume or value of imports to the volume or value of exports or to the amount of foreign exchange inflows associated with such enterprise; (e) to restrict sales of goods or services in its territory that such enterprise produces or supplies, by relating those sales in any way to the volume or value of its exports or foreign exchange inflows; (f) to transfer technology, a production process or other proprietary knowledge to a natural or legal person or any other entity in its territory (12); (g) to supply exclusively from the territory of that Party a good produced or a service supplied by the enterprise to a specific regional or world market; (h) to locate the headquarters for a specific region of the world which is broader than the territory of the Party or the world market in its territory; (i) to employ a given number or percentage of natural persons of that Party; (j) to achieve a given level or value of research and development in its territory; (k) to restrict the exportation or sale for export; or (l) with regard to any licence contract in existence at the time the requirement is imposed or enforced, or any commitment or undertaking is enforced, or with regard to any future licence contract freely entered into between the enterprise and a natural or legal person or any other entity in its territory, if the requirement is imposed or enforced or the commitment or undertaking is enforced, in a manner that constitutes direct interference with that licence contract by an exercise of non-judicial governmental authority of a Party, to adopt: (i) a rate or amount of royalty below a certain level; or (ii) a given duration of the term of a licence contract. This point does not apply where the licence contract is concluded between the enterprise and the Party. For the purposes of this point, a "licence contract" means any contract concerning the licensing of technology, a production process, or other proprietary knowledge. 2. A Party shall not condition the receipt or continued receipt of an advantage, in connection with the establishment or operation of an enterprise in its territory, on compliance with any of the following requirements: (a) achieving a given level or percentage of domestic content; (b) purchasing, using or according a preference to goods produced or services supplied in its territory, or to purchase goods or services from natural or legal persons or any other entity in its territory; (c) relating in any way the volume or value of imports to the volume or value of exports or to the amount of foreign exchange inflows associated with that enterprise; (d) restricting the sales of goods or services in its territory that that enterprise produces or supplies by relating those sales in any way to the volume or value of its exports or foreign exchange inflows; or (e) restricting the exportation or sale for export. 3. Paragraph 2 shall not be construed as preventing a Party from conditioning the receipt or continued receipt of an advantage, in connection with the establishment or operation of any enterprise in its territory, on compliance with a requirement to locate production, supply a service, train or employ workers, construct or expand particular facilities, or carry out research and development, in its territory. 4. Points (f) and (l) of paragraph 1 of this Article do not apply where: (a) the requirement is imposed or enforced, or the commitment or undertaking is enforced, by a court or administrative tribunal, or by a competition authority pursuant to a Party's competition law to prevent or remedy a restriction or a distortion of competition; or (b) a Party authorises the use of an intellectual property right in accordance with Article 31 or Article 31bis of the TRIPS Agreement, or adopts or maintains measures requiring the disclosure of data or proprietary information that fall within the scope of, and are consistent with, paragraph 3 of Article 39 of the TRIPS Agreement. 5. Points (a) to (c) of paragraph 1 and points (a) and (b) of paragraph 2 do not apply to qualification requirements for goods or services with respect to participation in export promotion and foreign aid programmes. 6. For greater certainty, this Article does not preclude the enforcement by the competent authorities of a Party of any commitment or undertaking given between persons other than a Party which was not directly or indirectly imposed or required by that Party. 7. For greater certainty, points (a) and (b) of paragraph 2 do not apply to requirements imposed by an importing Party in relation to the content of goods necessary to qualify for preferential tariffs or preferential quotas. 8. Point (l) of paragraph 1 does not apply if the requirement is imposed or enforced, or the commitment or undertaking is enforced, by a tribunal as equitable remuneration under the Party's copyright laws. 9. A Party shall neither impose nor enforce any measure inconsistent with its obligations under the Agreement on Trade-Related Investment Measures (TRIMs), even where such measure has been listed by that Party in Annex 19 or 20. 10. For greater certainty, this Article shall not be construed as requiring a Party to permit a particular service to be supplied on a cross-border basis where that Party adopts or maintains restrictions or prohibitions on such provision of services which are consistent with the reservations, conditions or qualifications specified with respect to a sector, subsector or activity listed in Annex 19 or 20. 11. A condition for the receipt or continued receipt of an advantage referred to in paragraph 2 does not constitute a requirement or a commitment or undertaking for the purposes of paragraph 1. Article 133 Non-conforming measures and exceptions 1. Articles 128, 129, 130, 131 and 132 do not apply to: (a) any existing non-conforming measure of a Party at the level of: (i) for the Union: (A) the Union, as set out in the Schedule of the Union in Annex 19; (B) The central government of a Member State, as set out in the Schedule of the Union in Annex 19; (C) a regional government of a Member State, as set out in the Schedule of the Union in Annex 19; or (D) a local government, other than that referred to in point (C); and (ii) for the United Kingdom: (A) the central government, as set out in the Schedule of the United Kingdom in Annex 19; (B) a regional government, as set out in the Schedule of the United Kingdom in Annex 19; or (C) a local government; (b) the continuation or prompt renewal of any non-conforming measure referred to in point (a) of this paragraph; or (c) a modification to any non-conforming measure referred to in points (a) and (b) of this paragraph, to the extent that it does not decrease the conformity of the measure, as it existed immediately before the modification, with Article 128, 129, 130, 131 or 132. 2. Articles 128, 129, 130, 131 and 132 do not apply to a measure of a Party which is consistent with the reservations, conditions or qualifications specified with respect to a sector, subsector or activity listed in Annex 20. 3. Articles 129 and 130 of this Agreement do not apply to any measure that constitutes an exception to, or a derogation from, Article 3 or 4 of the TRIPS Agreement, as specifically provided for in Articles 3 to 5 of that Agreement. 4. For greater certainty, Articles 129 and 130 shall not be construed as preventing a Party from prescribing information requirements, including for statistical purposes, in connection with the establishment or operation of investors of the other Party or of covered enterprises, provided that it does not constitute a means to circumvent that Party's obligations under those Articles. CHAPTER 3 CROSS-BORDER TRADE IN SERVICES Article 134 Scope This Chapter applies to measures of a Party affecting the cross-border trade in services by service suppliers of the other Party. Article 135 Market access A Party shall not adopt or maintain, either on the basis of its entire territory or on the basis of a territorial sub-division, measures that: (a) impose limitations on: (i) the number of service suppliers that may supply a specific service, whether in the form of numerical quotas, monopolies, exclusive service suppliers or the requirement of an economic needs test; (ii) the total value of service transactions or assets in the form of numerical quotas or the requirement of an economic needs test; or (iii) the total number of service operations or on the total quantity of service output expressed in the terms of designated numerical units in the form of quotas or the requirement of an economic needs test (13); or (b) restrict or require specific types of legal entity or joint venture through which a service supplier may supply a service. Article 136 Local presence A Party shall not require a service supplier of the other Party to establish or maintain an enterprise or to be resident in its territory as a condition for the cross-border supply of a service. Article 137 National treatment 1. Each Party shall accord to services and service suppliers of the other Party treatment no less favourable than that it accords, in like situations, to its own services and service suppliers. 2. A Party may meet the requirement of paragraph 1 by according to services and service suppliers of the other Party either formally identical treatment or formally different treatment to that it accords to its own services and service suppliers. 3. Formally identical or formally different treatment shall be considered to be less favourable if it modifies the conditions of competition in favour of services or service suppliers of the Party compared to services or service suppliers of the other Party. 4. Nothing in this Article shall be construed as requiring either Party to compensate for inherent competitive disadvantages which result from the foreign character of the relevant services or service suppliers. Article 138 Most-favoured-nation treatment 1. Each Party shall accord to services and service suppliers of the other Party treatment no less favourable than that it accords, in like situations, to services and service suppliers of a third country. 2. Paragraph 1 shall not be construed as obliging a Party to extend to services and service suppliers of the other Party the benefit of any treatment resulting from: (a) an international agreement for the avoidance of double taxation or other international agreement or arrangement relating wholly or mainly to taxation; or (b) measures providing for recognition, including of the standards or criteria for the authorisation, licencing, or certification of a natural person or enterprise to carry out an economic activity, or of prudential measures as referred to in paragraph 3 of the GATS Annex on Financial Services. 3. For greater certainty, the existence of substantive provisions in other international agreements concluded by a Party with a third country, or mere formal transposition of those provisions into domestic law to the extent that it is necessary in order to incorporate them into the domestic legal order, do not in themselves constitute the "treatment" referred to in paragraph 1. Measures of a Party pursuant to those provisions may constitute such treatment and thus give rise to a breach of this Article. Article 139 Non-conforming measures 1. Articles 135, 136, 137 and 138 do not apply to: (a) any existing non-conforming measure of a Party at the level of: (i) for the Union: (A) the Union, as set out in the Schedule of the Union in Annex 19; (B) the central government of a Member State, as set out in the Schedule of the Union in Annex 19; (C) a regional government of a Member State, as set out in the Schedule of the Union in Annex 19; or (D) a local government, other than that referred to in point (C); and (ii) for the United Kingdom: (A) the central government, as set out in the Schedule of the United Kingdom in Annex 19; (B) a regional government, as set out in the Schedule of the United Kingdom in Annex 19; or (C) a local government; (b) the continuation or prompt renewal of any non-conforming measure referred to in point (a) of this paragraph; or (c) a modification to any non-conforming measure referred to in points (a) and (b) of this paragraph to the extent that it does not decrease the conformity of the measure, as it existed immediately before the modification, with Articles 135, 136, 137 and 138. 2. Articles 135, 136, 137 and 138 do not apply to any measure of a Party which is consistent with the reservations, conditions or qualifications specified with respect to a sector, subsector or activity listed in Annex 20. CHAPTER 4 ENTRY AND TEMPORARY STAY OF NATURAL PERSONS FOR BUSINESS PURPOSES Article 140 Scope and definitions 1. This Chapter applies to measures of a Party affecting the performance of economic activities through the entry and temporary stay in its territory of natural persons of the other Party, who are business visitors for establishment purposes, contractual service suppliers, independent professionals, intra-corporate transferees and short-term business visitors. 2. To the extent that commitments are not undertaken in this Chapter, all requirements provided for in the law of a Party regarding the entry and temporary stay of natural persons shall continue to apply, including laws and regulations concerning the period of stay. 3. Notwithstanding the provisions of this Chapter, all requirements provided for in the law of a Party regarding work and social security measures shall continue to apply, including laws and regulations concerning minimum wages and collective wage agreements. 4. Commitments on the entry and temporary stay of natural persons for business purposes do not apply in cases where the intent or effect of the entry and temporary stay is to interfere with or otherwise affect the outcome of any labour or management dispute or negotiation, or the employment of any natural person who is involved in that dispute. 5. For the purposes of this Chapter: (a) "business visitors for establishment purposes" means natural persons working in a senior position within a legal person of a Party, who: (i) are responsible for setting up an enterprise of such legal person in the territory of the other Party; (ii) do not offer or provide services or engage in any economic activity other than that which is required for the purposes of the establishment of that enterprise; and (iii) do not receive remuneration from a source located within the other Party; (b) "contractual service suppliers" means natural persons employed by a legal person of a Party (other than through an agency for placement and supply services of personnel), which is not established in the territory of the other Party and has concluded a bona fide contract, not exceeding 12 months, to supply services to a final consumer in the other Party requiring the temporary presence of its employees who: (i) have offered the same type of services as employees of the legal person for a period of not less than one year immediately preceding the date of their application for entry and temporary stay; (ii) possess, on that date, at least three years professional experience, obtained after having reached the age of majority, in the sector of activity that is the object of the contract, a university degree or a qualification demonstrating knowledge of an equivalent level and the professional qualifications legally required to exercise that activity in the other Party (14); and (iii) do not receive remuneration from a source located within the other Party; (c) "independent professionals" means natural persons engaged in the supply of a service and established as self-employed in the territory of a Party who: (i) have not established in the territory of the other Party; (ii) have concluded a bona fide contract (other than through an agency for placement and supply services of personnel) for a period not exceeding 12 months to supply services to a final consumer in the other Party, requiring their presence on a temporary basis; and (iii) possess, on the date of their application for entry and temporary stay, at least six years professional experience in the relevant activity, a university degree or a qualification demonstrating knowledge of an equivalent level and the professional qualifications legally required to exercise that activity in the other Party (15); (d) "intra-corporate transferees" means natural persons, who: (i) have been employed by a legal person of a Party, or have been partners in it, for a period, immediately preceding the date of the intra-corporate transfer, of not less than one year in the case of managers and specialists and of not less than six months in the case of trainee employees; (ii) at the time of application reside outside the territory of the other Party; (iii) are temporarily transferred to an enterprise of the legal person in the territory of the other Party which is a member of the same group as the originating legal person, including its representative office, subsidiary, branch or head company (16); and (iv) belong to one of the following categories: (A) managers (17); (B) specialists; or (C) trainee employees; (e) "manager" means a natural person working in a senior position, who primarily directs the management of the enterprise in the other Party, receiving general supervision or direction principally from the board of directors or from shareholders of the business or their equivalent and whose responsibilities include: (i) directing the enterprise or a department or subdivision thereof; (ii) supervising and controlling the work of other supervisory, professional or managerial employees; and (iii) having the authority to recommend hiring, dismissing or other personnel-related actions; (f) "specialist" means a natural person possessing specialised knowledge, essential to the enterprise's areas of activity, techniques or management, which is to be assessed taking into account not only knowledge specific to the enterprise, but also whether the person has a high level of qualification, including adequate professional experience of a type of work or activity requiring specific technical knowledge, including possible membership of an accredited profession; and (g) "trainee employee" means a natural person possessing a university degree who is temporarily transferred for career development purposes or to obtain training in business techniques or methods and is paid during the period of the transfer. (18) 6. The service contract referred to in points (b) and (c) of paragraph 5 shall comply with the requirements of the law of the Party where the contract is executed. Article 141 Intra-corporate transferees and business visitors for establishment purposes 1. Subject to the relevant conditions and qualifications specified in Annex 21: (a) each Party shall allow: (i) the entry and temporary stay of intra-corporate transferees; (ii) the entry and temporary stay of business visitors for establishment purposes without requiring a work permit or other prior approval procedure of similar intent; and (iii) the employment in its territory of intra-corporate transferees of the other Party; (b) a Party shall not maintain or adopt limitations in the form of numerical quotas or economic needs tests regarding the total number of natural persons that, in a specific sector, are allowed entry as business visitors for establishment purposes or that an investor of the other Party may employ as intra-corporate transferees, either on the basis of a territorial subdivision or on the basis of its entire territory; and (c) each Party shall accord to intra-corporate transferees and business visitors for establishment purposes of the other Party, during their temporary stay in its territory, treatment no less favourable than that it accords, in like situations, to its own natural persons. 2. The permissible length of stay shall be for a period of up to three years for managers and specialists, up to one year for trainee employees and up to 90 days within any six-month period for business visitors for establishment purposes. Article 142 Short-term business visitors 1. Subject to the relevant conditions and qualifications specified in Annex 21, each Party shall allow the entry and temporary stay of short-term business visitors of the other Party for the purposes of carrying out the activities listed in Annex 21, subject to the following conditions: (a) the short-term business visitors are not engaged in selling their goods or supplying services to the general public; (b) the short-term business visitors do not, on their own behalf, receive remuneration from within the Party where they are staying temporarily; and (c) the short-term business visitors are not engaged in the supply of a service in the framework of a contract concluded between a legal person that has not established in the territory of the Party where they are staying temporarily, and a consumer there, except as provided for in Annex 21. 2. Unless otherwise specified in Annex 21, a Party shall allow entry of short-term business visitors without the requirement of a work permit, economic needs test or other prior approval procedures of similar intent. 3. If short-term business visitors of a Party are engaged in the supply of a service to a consumer in the territory of the Party where they are staying temporarily in accordance with Annex 21, that Party shall accord to them, with regard to the supply of that service, treatment no less favourable than that it accords, in like situations, to its own service suppliers. 4. The permissible length of stay shall be for a period of up to 90 days in any six-month period. Article 143 Contractual service suppliers and independent professionals 1. In the sectors, subsectors and activities specified in Annex 22 and subject to the relevant conditions and qualifications specified therein: (a) a Party shall allow the entry and temporary stay of contractual service suppliers and independent professionals in its territory; (b) a Party shall not adopt or maintain limitations on the total number of contractual service suppliers and independent professionals of the other Party allowed entry and temporary stay, in the form of numerical quotas or an economic needs test; and (c) each Party shall accord to contractual service suppliers and independent professionals of the other Party, with regard to the supply of their services in its territory, treatment no less favourable than that it accords, in like situations, to its own service suppliers. 2. Access accorded under this Article relates only to the service which is the subject of the contract and does not confer entitlement to use the professional title of the Party where the service is provided. 3. The number of persons covered by the service contract shall not be greater than necessary to fulfil the contract, as it may be required by the law of the Party where the service is supplied. 4. The permissible length of stay shall be for a cumulative period of 12 months, or for the duration of the contract, whichever is less. Article 144 Non-conforming measures To the extent that the relevant measure affects the temporary stay of natural persons for business purposes, points (b) and (c) of Article 141(1), Article 142(3) and points (b) and (c) of Article 143(1) do not apply to: (a) any existing non-conforming measure of a Party at the level of: (i) for the Union: (A) the Union, as set out in the Schedule of the Union in Annex 19; (B) the central government of a Member State, as set out in the Schedule of the Union in Annex 19; (C) a regional government of a Member State, as set out in the Schedule of the Union in Annex 19; or (D) a local government, other than that referred to in point (C); and (ii) for the United Kingdom: (A) the central government, as set out in the Schedule of the United Kingdom in Annex 19; (B) a regional subdivision, as set out in the Schedule of the United Kingdom in Annex 19; or (C) a local government; (b) the continuation or prompt renewal of any non-conforming measure referred to in point (a) of this Article; (c) a modification to any non-conforming measure referred to in points (a) and (b) of this Article to the extent that it does not decrease the conformity of the measure, as it existed immediately before the modification, with points (b) and (c) of Article 141(1), Article 142(3) and points (b) and (c) of Article 143(1); or (d) any measure of a Party consistent with a condition or qualification specified in Annex 20. Article 145 Transparency 1. Each Party shall make publicly available information on relevant measures that pertain to the entry and temporary stay of natural persons of the other Party, referred to in Article 140(1). 2. The information referred to in paragraph 1 shall, to the extent possible, include the following information relevant to the entry and temporary stay of natural persons: (a) categories of visa, permits or any similar type of authorisation regarding the entry and temporary stay; (b) documentation required and conditions to be met; (c) method of filing an application and options on where to file, such as consular offices or online; (d) application fees and an indicative timeframe of the processing of an application; (e) the maximum length of stay under each type of authorisation described in point (a); (f) conditions for any available extension or renewal; (g) rules regarding accompanying dependants; (h) available review or appeal procedures; and (i) relevant laws of general application pertaining to the entry and temporary stay of natural persons for business purposes. 3. With respect to the information referred to in paragraphs 1 and 2, each Party shall endeavour to promptly inform the other Party of the introduction of any new requirements and procedures or of the changes in any requirements and procedures that affect the effective application for the grant of entry into, temporary stay in and, where applicable, permission to work in the former Party. CHAPTER 5 REGULATORY FRAMEWORK SECTION 1 DOMESTIC REGULATION Article 146 Scope and definitions 1. This Section applies to measures by the Parties relating to licensing requirements and procedures, qualification requirements and procedures, formalities and technical standards that affect: (a) cross-border trade in services; (b) establishment or operation; or (c) the supply of a service through the presence of a natural person of a Party in the territory of the other Party as set out in Article 140. As far as measures relating to technical standards are concerned, this Section only applies to measures that affect trade in services. For the purposes of this Section, the term "technical standards" does not include regulatory or implementing technical standards for financial services. 2. This Section does not apply to licensing requirements and procedures, qualification requirements and procedures, formalities and technical standards pursuant to a measure: (a) that does not conform with Article 128 or 129 and is referred to in points (a) to (c) of Article 133(1) or with Article 135, 136 or 137 and is referred to in points (a) to (c) of Article 139(1) or with points (b) and (c) of Article 141(1), or Article 142(3) or with points (b) and (c) of Article 143(1) and is referred to in Article 144; or (b) referred to in Article 133(2) or Article 139(2). 3. For the purposes of this Section, the following definitions apply: (a) "authorisation" means the permission to carry out any of the activities referred to in points (a) to (c) of paragraph 1 resulting from a procedure a natural or legal person must adhere to in order to demonstrate compliance with licensing requirements, qualification requirements, technical standards or formalities for the purposes of obtaining, maintaining or renewing that permission; and (b) "competent authority" means a central, regional or local government or authority or non-governmental body in the exercise of powers delegated by central, regional or local governments or authorities, which is entitled to take a decision concerning the authorisation referred to in point (a). Article 147 Submission of applications Each Party shall, to the extent practicable, avoid requiring an applicant to approach more than one competent authority for each application for authorisation. If an activity for which authorisation is requested is within the jurisdiction of multiple competent authorities, multiple applications for authorisation may be required. Article 148 Application timeframes If a Party requires authorisation, it shall ensure that its competent authorities, to the extent practicable, permit the submission of an application at any time throughout the year. If a specific time period for applying for authorisation exists, the Party shall ensure that the competent authorities allow a reasonable period of time for the submission of an application. Article 149 Electronic applications and acceptance of copies If a Party requires authorisation, it shall ensure that its competent authorities: (a) to the extent possible provide for applications to be completed by electronic means, including from within the territory of the other Party; and (b) accept copies of documents, that are authenticated in accordance with the Party's domestic law, in place of original documents, unless the competent authorities require original documents to protect the integrity of the authorisation process. Article 150 Processing of applications 1. If a Party requires authorisation, it shall ensure that its competent authorities: (a) process applications throughout the year. Where that is not possible, this information should be made public in advance, to the extent practicable; (b) to the extent practicable, provide an indicative timeframe for the processing of an application. That timeframe shall be reasonable to the extent practicable; (c) at the request of the applicant, provide without undue delay information concerning the status of the application; (d) to the extent practicable, ascertain without undue delay the completeness of an application for processing under the Party's domestic laws and regulations; (e) if they consider an application complete for the purposes of processing under the Party's domestic laws and regulations, (19) within a reasonable period of time after the submission of the application ensure that: (i) the processing of the application is completed; and (ii) the applicant is informed of the decision concerning the application, to the extent possible, in writing; (20) (f) if they consider an application incomplete for the purposes of processing under the Party's domestic laws and regulations, within a reasonable period of time, to the extent practicable: (i) inform the applicant that the application is incomplete; (ii) at the request of the applicant identify the additional information required to complete the application or otherwise provide guidance on why the application is considered incomplete; and (iii) provide the applicant with the opportunity to provide the additional information that is required to complete the application; (21) however, if none of the actions referred to in points (i), (ii) and (iii) is practicable, and the application is rejected due to incompleteness, the competent authorities shall ensure that they inform the applicant within a reasonable period of time; and (g) if an application is rejected, either upon their own initiative or upon request of the applicant, inform the applicant of the reasons for rejection and of the timeframe for an appeal against that decision and, if applicable, the procedures for resubmission of an application; an applicant shall not be prevented from submitting another application solely on the basis of a previously rejected application. 2. The Parties shall ensure that their competent authorities grant an authorisation as soon as it is established, on the basis of an appropriate examination, that the applicant meets the conditions for obtaining it. 3. The Parties shall ensure that, once granted, an authorisation enters into effect without undue delay, subject to the applicable terms and conditions. (22) Article 151 Fees 1. For all economic activities other than financial services, each Party shall ensure that the authorisation fees charged by its competent authorities are reasonable and transparent and do not in themselves restrict the supply of the relevant service or the pursuit of any other economic activity. Having regard to the cost and administrative burden, each Party is encouraged to accept payment of authorisation fees by electronic means. 2. With regard to financial services, each Party shall ensure that its competent authorities, with respect to authorisation fees that they charge, provide applicants with a schedule of fees or information on how fee amounts are determined, and do not use the fees as a means of avoiding the Party's commitments or obligations. 3. Authorisation fees do not include fees for the use of natural resources, payments for auction, tendering or other non-discriminatory means of awarding concessions or mandated contributions to universal service provision. Article 152 Assessment of qualifications If a Party requires an examination to assess the qualifications of an applicant for authorisation, it shall ensure that its competent authorities schedule such an examination at reasonably frequent intervals and provide a reasonable period of time to enable applicants to request to take the examination. To the extent practicable, each Party shall accept requests in electronic format to take such examinations and shall consider the use of electronic means in other aspects of examination processes. Article 153 Publication and information available 1. If a Party requires authorisation, the Party shall promptly publish the information necessary for persons carrying out or seeking to carry out the activities referred to in Article 146(1) for which the authorisation is required to comply with the requirements, formalities, technical standards and procedures for obtaining, maintaining, amending and renewing such authorisation. Such information shall include, to the extent it exists: (a) the licensing and qualification requirements and procedures and formalities; (b) contact information of relevant competent authorities; (c) authorisation fees; (d) applicable technical standards; (e) procedures for appeal or review of decisions concerning applications; (f) procedures for monitoring or enforcing compliance with the terms and conditions of licences or qualifications; (g) opportunities for public involvement, such as through hearings or comments; and (h) indicative timeframes for the processing of an application. For the purposes of this Section, "publish" means to include in an official publication, such as an official journal, or on an official website. Parties shall consolidate electronic publications into a single online portal or otherwise ensure that competent authorities make them easily accessible through alternative electronic means. 2. Each Party shall require each of its competent authorities to respond to any request for information or assistance, to the extent practicable. Article 154 Technical standards Each Party shall encourage its competent authorities, when adopting technical standards, to adopt technical standards developed through open and transparent processes, and shall encourage any body, including relevant international organisations, designated to develop technical standards to do so through open and transparent processes. Article 155 Conditions for authorisation 1. Each Party shall ensure that measures relating to authorisation are based on criteria which preclude the competent authorities from exercising their power of assessment in an arbitrary manner and may include, inter alia, competence and the ability to supply a service or any other economic activity, including to do so in compliance with a Party's regulatory requirements such as health and environmental requirements. For the avoidance of doubt, the Parties understand that in reaching decisions a competent authority may balance criteria. 2. The criteria referred to in paragraph 1 shall be: (a) clear and unambiguous; (b) objective and transparent; (c) pre-established; (d) made public in advance; (e) impartial; and (f) easily accessible. 3. If a Party adopts or maintains a measure relating to authorisation, it shall ensure that: (a) the competent authority concerned processes applications, and reaches and administers its decisions, objectively and impartially and in a manner independent of the undue influence of any person carrying out the economic activity for which authorisation is required; and (b) the procedures themselves do not prevent fulfilment of the requirements. Article 156 Limited numbers of licences If the number of licences available for a given activity is limited because of the scarcity of available natural resources or technical capacity, a Party shall apply a selection procedure to potential candidates which provides full guarantees of impartiality, objectivity and transparency, including, in particular, adequate publicity about the launch, conduct and completion of the procedure. In establishing the rules for the selection procedure, a Party may take into account legitimate policy objectives, including considerations of health, safety, the protection of the environment and the preservation of cultural heritage. SECTION 2 PROVISIONS OF GENERAL APPLICATION Article 157 Review procedures for administrative decisions A Party shall maintain judicial, arbitral or administrative tribunals or procedures which provide, on request of an affected investor or service supplier of the other Party, for the prompt review of, and if justified appropriate remedies for, administrative decisions that affect establishment or operation, cross-border trade in services or the supply of a service through the presence of a natural person of a Party in the territory of the other Party. For the purposes of this Section, "administrative decisions" means a decision or action with a legal effect that applies to a specific person, good or service in an individual case and covers the failure to take an administrative decision or take such action when that is so required by a Party's law. If such procedures are not independent of the competent authority entrusted with the administrative decision concerned, a Party shall ensure that the procedures in fact provide for an objective and impartial review. Article 158 Professional qualifications 1. Nothing in this Article shall prevent a Party from requiring that natural persons possess the necessary professional qualifications specified in the territory where the activity is performed, for the sector of activity concerned (23). 2. The professional bodies or authorities, which are relevant for the sector of activity concerned in their respective territories, may develop and provide joint recommendations on the recognition of professional qualifications to the Partnership Council. Such joint recommendations shall be supported by an evidence-based assessment of: (a) the economic value of an envisaged arrangement on the recognition of professional qualifications; and (b) the compatibility of the respective regimes, that is, the extent to which the requirements applied by each Party for the authorisation, licensing, operation and certification are compatible. 3. On receipt of a joint recommendation, the Partnership Council shall review its consistency with this Title within a reasonable period of time. The Partnership Council may, following such review, develop and adopt an arrangement on the conditions for the recognition of professional qualifications by decision as an annex to this Agreement, which shall be considered to form an integral part of this Title. (24) 4. An arrangement referred to in paragraph 3 shall provide for the conditions for recognition of professional qualifications acquired in the Union and professional qualifications acquired in the United Kingdom relating to an activity covered by this Title and Title III of this Heading. 5. The Guidelines for arrangements on the recognition of professional qualifications set out in Annex 24 shall be taken into account in the development of the joint recommendations referred to in paragraph 2 of this Article and by the Partnership Council when assessing whether to adopt such an Arrangement, as referred to in paragraph 3 of this Article. SECTION 3 DELIVERY SERVICES Article 159 Scope and definitions 1. This Section applies to measures of a Party affecting the supply of delivery services in addition to Chapters 1, 2, 3 and 4 of this Title, and to Sections 1 and 2 of this Chapter. 2. For the purposes of this Section, the following definitions apply: (a) "delivery services" means postal services, courier services, express delivery services or express mail services, which include the following activities: the collection, sorting, transport, and delivery of postal items; (b) "express delivery services" means the collection, sorting, transport and delivery of postal items at accelerated speed and reliability and may include value added elements such as collection from point of origin, personal delivery to the addressee, tracing, possibility of changing the destination and addressee in transit or confirmation of receipt; (c) "express mail services" means international express delivery services supplied through the EMS Cooperative, which is the voluntary association of designated postal operators under Universal Postal Union (UPU); (d) "licence" means an authorisation that a regulatory authority of a Party may require of an individual supplier in order for that supplier to offer postal or courier services; (e) "postal item" means an item up to 31.5 kg addressed in the final form in which it is to be carried by any type of supplier of delivery services, whether public or private and may include items such as a letter, parcel, newspaper or catalogue; (f) "postal monopoly" means the exclusive right to supply specified delivery services within a Party's territory or a subdivision thereof pursuant to the law of that Party; and (g) "universal service" means the permanent supply of a delivery service of specified quality at all points in the territory of a Party or a subdivision thereof at affordable prices for all users. Article 160 Universal service 1. Each Party has the right to define the kind of universal service obligation it wishes to maintain and to decide on its scope and implementation. Any universal service obligation shall be administered in a transparent, non-discriminatory and neutral manner with regard to all suppliers subject to the obligation. 2. If a Party requires inbound express mail services to be supplied on a universal service basis, it shall not accord preferential treatment to those services over other international express delivery services. Article 161 Universal service funding A party shall not impose fees or other charges on the supply of a delivery service that is not a universal service for the purposes of funding the supply of a universal service. This Article does not apply to generally applicable taxation measures or administrative fees. Article 162 Prevention of market distortive practices Each party shall ensure that suppliers of delivery services subject to a universal service obligation or postal monopolies do not engage in market distortive practices such as: (a) using revenues derived from the supply of the service subject to a universal service obligation or from a postal monopoly to cross-subsidise the supply of an express delivery service or any delivery service which is not subject to a universal service obligation; or (b) unjustifiably differentiating between consumers with respect to tariffs or other terms and conditions for the supply of a service subject to a universal service or a postal monopoly. Article 163 Licences 1. If a Party requires a licence for the provision of delivery services, it shall make publicly available: (a) all the licensing requirements and the period of time normally required to reach a decision concerning an application for a licence; and (b) the terms and conditions of licences. 2. The procedures, obligations and requirements of a licence shall be transparent, non-discriminatory and based on objective criteria. 3. If a licence application is rejected by the competent authority, it shall inform the applicant of the reasons for the rejection in writing. Each Party shall establish an appeal procedure through an independent body available to applicants whose licence has been rejected. That body may be a court. Article 164 Independence of the regulatory body 1. Each Party shall establish or maintain a regulatory body which shall be legally distinct from and functionally independent from any supplier of delivery services. If a Party owns or controls a supplier of delivery services, it shall ensure the effective structural separation of the regulatory function from activities associated with ownership or control. 2. The regulatory bodies shall perform their tasks in a transparent and timely manner and have adequate financial and human resources to carry out the task assigned to them. Their decisions shall be impartial with respect to all market participants. SECTION 4 TELECOMMUNICATIONS SERVICES Article 165 Scope This Section applies to measures of a Party affecting the supply of telecommunications services in addition to Chapters 1, 2, 3 and 4 of this Title, and to Sections 1 and 2 of this Chapter. Article 166 Definitions For the purposes of this Section, the following definitions apply: (a) "associated facilities" means associated services, physical infrastructure and other facilities or elements associated with a telecommunications network or telecommunications service which enable or support the supply of services via that network or service or have the potential to do so; (b) "end user" means a final consumer of, or subscriber to, a public telecommunications service, including a service supplier other than a supplier of public telecommunications services; (c) "essential facilities" means facilities of a public telecommunications network or a public telecommunications service that: (i) are exclusively or predominantly provided by a single or limited number of suppliers; and (ii) cannot feasibly be economically or technically substituted in order to provide a service; (d) "interconnection" means the linking of public telecommunications networks used by the same or different suppliers of telecommunications networks or telecommunications services in order to allow the users of one supplier to communicate with users of the same or another supplier or to access services provided by another supplier, irrespective of whether those services are provided by the suppliers involved or any other supplier who has access to the network; (e) "international mobile roaming service" means a commercial mobile service provided pursuant to a commercial agreement between suppliers of public telecommunications services that enables an end user to use its home mobile handset or other device for voice, data or messaging services while outside the territory in which the end user's home public telecommunications network is located; (f) "internet access service" means a public telecommunications service that provides access to the internet and thereby connectivity to virtually all end points of the internet, irrespective of the network technology and terminal equipment used; (g) "leased circuit" means telecommunications services or facilities, including those of a virtual nature, that set aside capacity for the dedicated use by, or availability to, a user between two or more designated points; (h) "major supplier" means a supplier of telecommunications networks or telecommunications services which has the ability to materially affect the terms of participation, having regard to price and supply, in a relevant market for telecommunications networks or telecommunications services as a result of control over essential facilities or the use of its position in that market; (i) "network element" means a facility or equipment used in supplying a telecommunications service, including features, functions and capabilities provided by means of that facility or equipment; (j) "number portability" means the ability of subscribers who so request to retain the same telephone numbers, at the same location in the case of a fixed line, without impairment of quality, reliability or convenience when switching between the same category of suppliers of public telecommunications services; (k) "public telecommunications network" means any telecommunications network used wholly or mainly for the provision of public telecommunications services which supports the transfer of information between network termination points; (l) "public telecommunications service" means any telecommunications service that is offered to the public generally; (m) "subscriber" means any natural or legal person which is party to a contract with a supplier of public telecommunications services for the supply of such services; (n) "telecommunications" means the transmission and reception of signals by any electromagnetic means; (o) "telecommunications network" means transmission systems and, where applicable, switching or routing equipment and other resources, including network elements which are not active, which permit the transmission and reception of signals by wire, radio, optical, or other electromagnetic means; (p) "telecommunications regulatory authority" means the body or bodies charged by a Party with the regulation of telecommunications networks and telecommunications services covered by this Section; (q) "telecommunications service" means a service which consists wholly or mainly in the transmission and reception of signals, including broadcasting signals, over telecommunications networks, including those used for broadcasting, but not a service providing, or exercising editorial control over, content transmitted using telecommunications networks and telecommunications services; (r) "universal service" means the minimum set of services of specified quality that must be made available to all users, or to a set of users, in the territory of a Party, or in a subdivision thereof, regardless of their geographical location and at an affordable price; and (s) "user" means any natural or legal person using a public telecommunications service. Article 167 Telecommunications regulatory authority 1. Each Party shall establish or maintain a telecommunications regulatory authority that: (a) is legally distinct and functionally independent from any supplier of telecommunications networks, telecommunications services or telecommunications equipment; (b) uses procedures and issues decisions that are impartial with respect to all market participants; (c) acts independently and does not seek or take instructions from any other body in relation to the exercise of the tasks assigned to it by law to enforce the obligations set out in Articles 169, 170, 171, 173 and 174; (d) has the regulatory power, as well as adequate financial and human resources, to carry out the tasks mentioned in point (c) of this Article; (e) has the power to ensure that suppliers of telecommunications networks or telecommunications services provide it, promptly upon request, with all the information (25), including financial information, which is necessary to enable it to carry out the tasks mentioned in point (c) of this Article; and (f) exercises its powers transparently and in a timely manner. 2. Each Party shall ensure that the tasks assigned to the telecommunications regulatory authority are made public in an easily accessible and clear form, in particular where those tasks are assigned to more than one body. 3. A Party that retains ownership or control of suppliers of telecommunications networks or telecommunications services shall ensure the effective structural separation of the regulatory function from activities associated with ownership or control. 4. Each Party shall ensure that a user or supplier of telecommunications networks or telecommunications services affected by a decision of the telecommunications regulatory authority has a right of appeal before an appeal body which is independent of the regulatory authority and other affected parties. Pending the outcome of the appeal, the decision shall stand, unless interim measures are granted in accordance with the Party's law. Article 168 Authorisation to provide telecommunications networks or services 1. Each Party shall permit the provision of telecommunications networks or telecommunications services without a prior formal authorisation. 2. Each Party shall make publicly available all the criteria, applicable procedures and terms and conditions under which suppliers are permitted to provide telecommunications networks or telecommunications services. 3. Any authorisation criteria and applicable procedures shall be as simple as possible, objective, transparent, non-discriminatory and proportionate. Any obligations and conditions imposed on or associated with an authorisation shall be non-discriminatory, transparent and proportionate, and shall be related to the services or networks provided. 4. Each Party shall ensure that an applicant for an authorisation receives in writing the reasons for any denial or revocation of an authorisation or the imposition of supplier-specific conditions. In such cases, the applicant shall have a right of appeal before an appeal body. 5. Administrative fees imposed on suppliers shall be objective, transparent, non-discriminatory and commensurate with the administrative costs reasonably incurred in the management, control and enforcement of the obligations set out in this Section (26). Article 169 Interconnection Each Party shall ensure that a supplier of public telecommunications networks or public telecommunications services has the right and, when so requested by another supplier of public telecommunications networks or public telecommunications services, the obligation to negotiate interconnection for the purposes of providing public telecommunications networks or public telecommunications services. Article 170 Access and use 1. Each Party shall ensure that any covered enterprise or service supplier of the other Party is accorded access to and use of public telecommunications networks or public telecommunications services on reasonable and non-discriminatory (27) terms and conditions. This obligation shall be applied, inter alia, to paragraphs 2 to 5. 2. Each Party shall ensure that covered enterprises or service suppliers of the other Party have access to and use of any public telecommunications network or public telecommunications service offered within or across its border, including private leased circuits, and to that end shall ensure, subject to paragraph 5, that such enterprises and suppliers are permitted: (a) to purchase or lease and attach terminal or other equipment which interfaces with the network and which is necessary to conduct their operations; (b) to interconnect private leased or owned circuits with public telecommunications networks or with circuits leased or owned by another covered enterprise or service supplier; and (c) to use the operating protocols of their choice in their operations, other than as necessary to ensure the availability of telecommunications services to the public generally. 3. Each Party shall ensure that covered enterprises or service suppliers of the other Party may use public telecommunications networks and public telecommunications services for the movement of information within and across borders, including for their intra-corporate communications, and for access to information contained in databases or otherwise stored in machine-readable form in the territory of either Party. 4. Notwithstanding paragraph 3, a Party may take such measures as are necessary to ensure the security and confidentiality of communications, subject to the requirement that such measures are not applied in a manner which would constitute either a disguised restriction on trade in services or a means of arbitrary or unjustifiable discrimination or of nullification or impairment of benefits under this Title. 5. Each Party shall ensure that no condition is imposed on access to and use of public telecommunications networks or services other than as necessary: (a) to safeguard the public service responsibilities of suppliers of public telecommunications networks or public telecommunications services, in particular their ability to make their services available to the public generally; or (b) to protect the technical integrity of public telecommunications networks or services. Article 171 Resolution of telecommunications disputes 1. Each Party shall ensure that, in the event of a dispute arising between suppliers of telecommunications networks or telecommunications services in connection with rights and obligations that arise from this Section, and upon request of either party involved in the dispute, the telecommunications regulatory authority issues a binding decision within a reasonable timeframe to resolve the dispute. 2. The decision by the telecommunications regulatory authority shall be made available to the public, having regard to the requirements of business confidentiality. The parties concerned shall be given a full statement of the reasons on which it is based and shall have the right of appeal referred to in Article 167(4). 3. The procedure referred to in paragraphs 1 and 2 shall not preclude either party concerned from bringing an action before a judicial authority. Article 172 Competitive safeguards on major suppliers Each Party shall introduce or maintain appropriate measures for the purpose of preventing suppliers of telecommunications networks or telecommunications services who, alone or together, are a major supplier from engaging in or continuing anti-competitive practices. These anti-competitive practices shall include in particular: (a) engaging in anti-competitive cross-subsidisation; (b) using information obtained from competitors with anti-competitive results; and (c) not making available to other service suppliers on a timely basis technical information about essential facilities and commercially relevant information which are necessary for them to provide services. Article 173 Interconnection with major suppliers 1. Each Party shall ensure that major suppliers of public telecommunications networks or public telecommunications services provide interconnection at any technically feasible point in the network. Such interconnection shall be provided: (a) under non-discriminatory terms and conditions (including as regards rates, technical standards, specifications, quality and maintenance) and of a quality no less favourable than that provided for the own like services of such major supplier, or for like services of its subsidiaries or other affiliates; (b) in a timely fashion, on terms and conditions (including as regards rates, technical standards, specifications, quality and maintenance) that are transparent, reasonable, having regard to economic feasibility, and sufficiently unbundled so that the supplier need not pay for network elements or facilities that it does not require for the service to be provided; and (c) upon request, at points in addition to the network termination points offered to the majority of users, subject to charges that reflect the cost of construction of necessary additional facilities. 2. The procedures applicable for interconnection to a major supplier shall be made publicly available. 3. Major suppliers shall make publicly available either their interconnection agreements or their reference interconnection offers as appropriate. Article 174 Access to major suppliers' essential facilities Each Party shall ensure that major suppliers in its territory make their essential facilities available to suppliers of telecommunications networks or telecommunications services on reasonable, transparent and non-discriminatory terms and conditions for the purpose of providing public telecommunications services, except where this is not necessary to achieve effective competition on the basis of the facts collected and the assessment of the market conducted by the telecommunications regulatory authority. The major supplier's essential facilities may include network elements, leased circuits services and associated facilities. Article 175 Scarce resources 1. Each Party shall ensure that the allocation and granting of rights of use of scarce resources, including radio spectrum, numbers and rights of way, is carried out in an open, objective, timely, transparent, non-discriminatory and proportionate manner and by taking into account general interest objectives. Procedures, and conditions and obligations attached to rights of use, shall be based on objective, transparent, non-discriminatory and proportionate criteria. 2. The current use of allocated frequency bands shall be made publicly available, but detailed identification of radio spectrum allocated for specific government uses is not required. 3. Parties may rely on market-based approaches, such as bidding procedures, to assign spectrum for commercial use. 4. The Parties understand that measures of a Party allocating and assigning spectrum and managing frequency are not in and of themselves inconsistent with Articles 128 and 135. Each Party retains the right to establish and apply spectrum and frequency management measures that may have the effect of limiting the number of suppliers of telecommunications services, provided that it does so in a manner consistent with this Agreement. This includes the ability to allocate frequency bands taking into account current and future needs and spectrum availability. Article 176 Universal service 1. Each Party has the right to define the kind of universal service obligations it wishes to maintain and to decide on their scope and implementation. 2. Each Party shall administer the universal service obligations in a proportionate, transparent, objective and non-discriminatory way, which is neutral with respect to competition and not more burdensome than necessary for the kind of universal service defined by the Party. 3. Each Party shall ensure that procedures for the designation of universal service suppliers are open to all suppliers of public telecommunications networks or public telecommunications services. Such designation shall be made through an efficient, transparent and non-discriminatory mechanism. 4. If a Party decides to compensate the universal service suppliers, it shall ensure that such compensation does not exceed the net cost caused by the universal service obligation. Article 177 Number portability Each Party shall ensure that suppliers of public telecommunications services provide number portability on reasonable terms and conditions. Article 178 Open internet access 1. Each Party shall ensure that, subject to its laws and regulations, suppliers of internet access services enable users of those services to: (a) access and distribute information and content, use and provide applications and services of their choice, subject to non-discriminatory, reasonable, transparent and proportionate network management; and (b) use devices of their choice, provided that such devices do not harm the security of other devices, the network or services provided over the network. 2. For greater certainty, nothing in this Article shall prevent the Parties from adopting measures with the aim of protecting public safety with regards to users online. Article 179 Confidentiality of information 1. Each Party shall ensure that suppliers that acquire information from another supplier in the process of negotiating arrangements pursuant to Articles 169, 170, 173 and 174 use that information solely for the purpose for which it was supplied and respect at all times the confidentiality of information transmitted or stored. 2. Each Party shall ensure the confidentiality of communications and related traffic data transmitted in the use of public telecommunications networks or public telecommunications services subject to the requirement that measures applied to that end do not constitute a means of arbitrary or unjustifiable discrimination or a disguised restriction on trade in services. Article 180 Foreign shareholding With regard to the provision of telecommunications networks or telecommunications services through establishment and notwithstanding Article 133, a Party shall not impose joint venture requirements or limit the participation of foreign capital in terms of maximum percentage limits on foreign shareholding or the total value of individual or aggregate foreign investment. Article 181 International mobile roaming (28) 1. The Parties shall endeavour to cooperate on promoting transparent and reasonable rates for international mobile roaming services in ways that can help promote the growth of trade among the Parties and enhance consumer welfare. 2. Parties may choose to take steps to enhance transparency and competition with respect to international mobile roaming rates and technological alternatives to roaming services, such as: (a) ensuring that information regarding retail rates is easily accessible to end users; and (b) minimising impediments to the use of technological alternatives to roaming, whereby end users visiting the territory of a Party from the territory of the other Party can access telecommunications services using the device of their choice. 3. Each Party shall encourage suppliers of public telecommunications services in its territory to make publicly available information on retail rates for international mobile roaming services for voice, data and text messages offered to their end users when visiting the territory of the other Party. 4. Nothing in this Article shall require a Party to regulate rates or conditions for international mobile roaming services. SECTION 5 FINANCIAL SERVICES Article 182 Scope 1. This Section applies to measures of a Party affecting the supply of financial services in addition to Chapters 1, 2, 3 and 4 of this Title, and to Sections 1 and 2 of this Chapter. 2. For the purposes of this Section, the term "activities performed in the exercise of governmental authority" referred to in point (f) of Article 124 means the following (29): (a) activities conducted by a central bank or a monetary authority or by any other public entity in pursuit of monetary or exchange rate policies; (b) activities forming part of a statutory system of social security or public retirement plans; and (c) other activities conducted by a public entity for the account or with the guarantee or using the financial resources of the Party or its public entities. 3. For the purposes of the application of point (f) of Article 124 to this Section, if a Party allows any of the activities referred to in point (b) or (c) of paragraph 2 of this Article to be conducted by its financial service suppliers in competition with a public entity or a financial service supplier, "activities performed in the exercise of governmental authority" does not include those activities. 4. Point (a) of Article 124 does not apply to services covered by this Section. Article 183 Definitions For the purposes of this Title, the following definitions apply: (a) "financial service" means any service of a financial nature offered by a financial service supplier of a Party and includes the following activities: (i) insurance and insurance-related services: (A) direct insurance (including co-insurance): (aa) life; (bb) non-life; (B) reinsurance and retrocession; (C) insurance intermediation, such as brokerage and agency; and (D) services auxiliary to insurance, such as consultancy, actuarial, risk assessment and claim settlement services; (ii) banking and other financial services (excluding insurance): (A) acceptance of deposits and other repayable funds from the public; (B) lending of all types, including consumer credit, mortgage credit, factoring and financing of commercial transaction; (C) financial leasing; (D) all payment and money transmission services, including credit, charge and debit cards, travellers cheques and bankers drafts; (E) guarantees and commitments; (F) trading for own account or for account of customers, whether on an exchange, in an over-the-counter market or otherwise, the following: (aa) money market instruments (including cheques, bills, certificates of deposits); (bb) foreign exchange; (cc) derivative products including, but not limited to, futures and options; (dd) exchange rate and interest rate instruments, including products such as swaps, forward rate agreements; (ee) transferable securities; and (ff) other negotiable instruments and financial assets, including bullion; (G) participation in issues of all kinds of securities, including underwriting and placement as agent (whether publicly or privately) and provision of services related to such issues; (H) money broking; (I) asset management, such as cash or portfolio management, all forms of collective investment management, pension fund management, custodial, depository and trust services; (J) settlement and clearing services for financial assets, including securities, derivative products, and other negotiable instruments; (K) provision and transfer of financial information, and financial data processing and related software; and (L) advisory, intermediation and other auxiliary financial services on all the activities listed in points (A) to (K), including credit reference and analysis, investment and portfolio research and advice, advice on acquisitions and on corporate restructuring and strategy; (b) "financial service supplier" means any natural or legal person of a Party that seeks to supply or supplies financial services and does not include a public entity; (c) "new financial service" means a service of a financial nature including services related to existing and new products or the manner in which a product is delivered, that is not supplied by any financial service supplier in the territory of a Party but which is supplied in the territory of the other Party; (d) "public entity" means: (i) a government, a central bank or a monetary authority, of a Party, or an entity owned or controlled by a Party, that is principally engaged in carrying out governmental functions or activities for governmental purposes, not including an entity principally engaged in supplying financial services on commercial terms; or (ii) a private entity, performing functions normally performed by a central bank or monetary authority, when exercising those functions; (e) "self-regulatory organisation" means any non-governmental body, including a securities or futures exchange or market, clearing agency, other organisation or association, that exercises regulatory or supervisory authority over financial service suppliers by statute or delegation from central, regional or local governments or authorities, where applicable. Article 184 Prudential carve-out 1. Nothing in this Agreement shall prevent a Party from adopting or maintaining measures for prudential reasons (30), such as: (a) the protection of investors, depositors, policy-holders or persons to whom a fiduciary duty is owed by a financial service supplier; or (b) ensuring the integrity and stability of a Party's financial system. 2. Where such measures do not conform with the provisions of this Agreement, they shall not be used as a means of avoiding the Party's commitments or obligations under this Agreement. Article 185 Confidential information Without prejudice to Part Three, nothing in this Agreement shall be construed to require a Party to disclose information relating to the affairs and accounts of individual consumers or any confidential or proprietary information in the possession of public entities. Article 186 International standards The Parties shall make their best endeavours to ensure that internationally agreed standards in the financial services sector for regulation and supervision, for the fight against money laundering and terrorist financing and for the fight against tax evasion and avoidance, are implemented and applied in their territory. Such internationally agreed standards are, inter alia, those adopted by: the G20; the Financial Stability Board; the Basel Committee on Banking Supervision, in particular its "Core Principle for Effective Banking Supervision"; the International Association of Insurance Supervisors, in particular its "Insurance Core Principles"; the International Organisation of Securities Commissions, in particular its "Objectives and Principles of Securities Regulation"; the Financial Action Task Force; and the Global Forum on Transparency and Exchange of Information for Tax Purposes of the Organisation for Economic Cooperation and Development. Article 187 Financial services new to the territory of a Party 1. Each Party shall permit a financial service supplier of the other Party established in its territory to supply any new financial service that it would permit its own financial service suppliers to supply in accordance with its law in like situations, provided that the introduction of the new financial service does not require the adoption of a new law or the amendment of an existing law. This does not apply to branches of the other Party established in the territory of a Party. 2. A Party may determine the institutional and legal form through which the service may be supplied and require authorisation for the supply of the service. Where such authorisation is required, a decision shall be made within a reasonable time and the authorisation may only be refused for prudential reasons. Article 188 Self-regulatory organisations Where a Party requires membership of, participation in, or access to, any self-regulatory organisation in order for financial service suppliers of the other Party to supply financial services in its territory, the Party shall ensure observance by that self-regulatory organisation of the obligations under Articles 129, 130, 137 and 138. Article 189 Clearing and payment systems Under terms and conditions that accord national treatment, each Party shall grant to financial service suppliers of the other Party established in its territory access to payment and clearing systems operated by public entities, and to official funding and refinancing facilities available in the normal course of ordinary business. This Article does not confer access to the Party's lender of last resort facilities. SECTION 6 INTERNATIONAL MARITIME TRANSPORT SERVICES Article 190 Scope and definitions 1. This Section applies to measures of a Party affecting the supply of international maritime transport services in addition to Chapters 1, 2, 3, 4 and Section 1 of this Chapter. 2. For the purposes of this Section and Chapters 1, 2, 3 and 4 of this Title, the following definitions apply: (a) "international maritime transport services" means the transport of passengers or cargo by sea-going vessels between a port of one Party and a port of the other Party or of a third country, or between ports of different Member States, including the direct contracting with providers of other transport services, with a view to covering door-to-door or multimodal transport operations under a single transport document, but does not include the right to provide such other transport services; (b) "door-to-door or multimodal transport operations" means the transport of international cargo using more than one mode of transport, that includes an international sea-leg, under a single transport document; (c) "international cargo" means cargo transported between a port of one Party and a port of the other Party or of a third country, or between ports of different Member States; (d) "maritime auxiliary services" means maritime cargo handling services, customs clearance services, container station and depot services, maritime agency services, maritime freight forwarding services and storage and warehousing services; (e) "maritime cargo handling services" means activities exercised by stevedore companies, including terminal operators but not including the direct activities of dockers if the workforce is organised independently of the stevedoring or terminal operator companies; the activities covered include the organisation and supervision of: (i) loading or discharging of cargo to or from a ship; (ii) the lashing or unlashing of cargo; and (iii) the reception or delivery and safekeeping of cargoes before shipment or after discharge; (f) "customs clearance services" means activities consisting in carrying out, on behalf of another party, customs formalities concerning import, export or through transport of cargoes, irrespective of whether these services are the main activity of the service supplier or a usual complement of its main activity; (g) "container station and depot services" means activities that consist of storing, stuffing, stripping or repairing of containers and making containers available for shipment, whether in port areas or inland; (h) "maritime agency services" means activities that consist of representing, within a given geographic area, as an agent the business interests of one or more shipping lines or shipping companies, for the following purposes: (i) marketing and sales of maritime transport and related services, from quotation to invoicing, issuance of bills of lading on behalf of the lines or companies, acquisition and resale of the necessary related services, preparation of documentation and provision of business information; and (ii) acting on behalf of the lines or companies organising the call of the ship or taking over cargoes when required; (i) "feeder services" means, without prejudice to the scope of activities that may be considered cabotage under the relevant national legislation, the pre- and onward transportation by sea of international cargo, including containerised, break bulk and dry or liquid bulk cargo, between ports located in the territory of a Party, provided such international cargo is "en route", that is, directed to a destination, or coming from a port of shipment, outside the territory of that Party; (j) "maritime freight forwarding services" means the activity consisting of organising and monitoring shipment operations on behalf of shippers, through the arrangement of transport and related services, preparation of documentation and provision of business information; (k) "port services" means services provided inside a maritime port area or on the waterway access to such area by the managing body of a port, its subcontractors, or other service providers to support the transport of cargo or passengers; and (l) "storage and warehousing services" means storage services of frozen or refrigerated goods, bulk storage services of liquids or gases, and other storage or warehousing services. Article 191 Obligations 1. Without prejudice to non-conforming measures or other measures referred to in Articles 133 and 139, each Party shall implement the principle of unrestricted access to the international maritime markets and trades on a commercial and non-discriminatory basis by: (a) according to ships flying the flag of the other Party, or operated by service suppliers of the other Party, treatment no less favourable than that accorded to its own ships with regard to, inter alia: (i) access to ports; (ii) the use of port infrastructure; (iii) the use of maritime auxiliary services; and (iv) customs facilities and the assignment of berths and facilities for loading and unloading, including related fees and charges; (b) making available to international maritime transport service suppliers of the other Party, on terms and conditions which are both reasonable and no less favourable than those applicable to its own suppliers or vessels or to vessels or suppliers of a third country (including fees and charges, specifications and quality of the service to be provided), the following port services: pilotage, towing and tug assistance, provisioning, fuelling and watering, garbage collecting and ballast waste disposal, port captain's services, navigation aids, emergency repair facilities, anchorage, berth, berthing and unberthing services and shore-based operational services essential to ship operations, including communications, water and electrical supplies; (c) permitting international maritime transport service suppliers of the other Party, subject to the authorisation by the competent authority where applicable, to re-position owned or leased empty containers, which are not being carried as cargo against payment, between ports of the United Kingdom or between ports of a Member State; and (d) permitting international maritime transport service suppliers of the other Party to provide feeder services between ports of the United Kingdom or between ports of a Member State, subject to the authorisation by the competent authority where applicable. 2. In applying the principle referred to in paragraph 1, a Party shall: (a) not introduce cargo-sharing arrangements in future agreements with third countries concerning international maritime transport services, including dry and liquid bulk and liner trade, and terminate, within a reasonable period of time, such cargo-sharing arrangements in case they exist in previous agreements; (b) not adopt or maintain a measure that requires all or part of any international cargo to be transported exclusively by vessels registered in that Party or owned or controlled by natural persons of that Party; (c) abolish and abstain from introducing any unilateral measures or administrative, technical and other obstacles which could constitute a disguised restriction or have discriminatory effects on the free supply of international maritime transport services; and (d) not prevent international maritime transport service suppliers of the other Party from directly contracting with other transport service suppliers for door-to-door or multimodal transport operations. SECTION 7 LEGAL SERVICES Article 192 Scope 1. This Section applies to measures of a Party affecting the supply of designated legal services in addition to Chapters 1, 2, 3 and 4 of this Title and to Sections 1 and 2 of this Chapter. 2. Nothing in this Section shall affect the right of a Party to regulate and supervise the supply of designated legal services in its territory in a non-discriminatory manner. Article 193 Definitions For the purposes of this Section, the following definitions apply: (a) "designated legal services" means legal services in relation to home jurisdiction law and public international law, excluding Union law; (b) "home jurisdiction" means the jurisdiction (or a part of the jurisdiction) of the Member State or of the United Kingdom in which a lawyer acquired their home jurisdiction professional title or, in the case of a lawyer who has acquired a home jurisdiction professional title in more than one jurisdiction, any of those jurisdictions; (c) "home jurisdiction law" means the law of the lawyer's home jurisdiction (31); (d) "home jurisdiction professional title" means: (i) for a lawyer of the Union, a professional title acquired in a Member State authorising the supply of legal services in that Member State; or (ii) for a lawyer of the United Kingdom, the title of advocate, barrister or solicitor, authorising the supply of legal services in any part of the jurisdiction of the United Kingdom; (e) "lawyer" means: (i) a natural person of the Union who is authorised in a Member State to supply legal services under a home jurisdiction professional title; or (ii) a natural person of the United Kingdom who is authorised in any part of the jurisdiction of the United Kingdom to supply legal services under a home jurisdiction professional title; (f) "lawyer of the other Party" means: (i) where "the other Party" is the Union, a lawyer referred to in point (e)(i); or (ii) where "the other Party" is the United Kingdom, a lawyer referred to in point (e)(ii); and (g) "legal services" means the following services: (i) legal advisory services; and (ii) legal arbitration, conciliation and mediation services (but excluding such services when supplied by natural persons as set out in Article 140). (32) "Legal services" do not include legal representation before administrative agencies, the courts, and other duly constituted official tribunals of a Party, legal advisory and legal authorisation, documentation and certification services supplied by legal professionals entrusted with public functions in the administration of justice such as notaries, "huissiers de justice" or other "officiers publics et ministériels", and services supplied by bailiffs who are appointed by an official act of government. Article 194 Obligations 1. A Party shall allow a lawyer of the other Party to supply in its territory designated legal services under that lawyer's home jurisdiction professional title in accordance with Articles 128, 129, 135, 137 and 143. 2. Where a Party (the "host jurisdiction") requires registration in its territory as a condition for a lawyer of the other Party to supply designated legal services pursuant to paragraph 1, the requirements and process for such registration shall not: (a) be less favourable than those which apply to a natural person of a third country who is supplying legal services in relation to third country law or public international law under that person's third country professional title in the territory of the host jurisdiction; and (b) amount to or be equivalent to any requirement to requalify into or be admitted to the legal profession of the host jurisdiction. 3. Paragraph 4 applies to the supply of designated legal services pursuant to paragraph 1 through establishment. 4. A Party shall allow a legal person of the other Party to establish a branch in its territory through which designated legal services (33) are supplied pursuant to paragraph 1, in accordance with and subject to the conditions set out in Chapter 2 of this Title. This shall be without prejudice to requirements that a certain percentage of the shareholders, owners, partners, or directors of a legal person be qualified or practice a certain profession such as lawyers or accountants. Article 195 Non-conforming measures 1. Article 194 does not apply to: (a) any existing non-conforming measure of a Party at the level of: (i) for the Union: (A) the Union, as set out in the Schedule of the Union in Annex 19; (B) the central government of a Member State, as set out in the Schedule of the Union in Annex 19; (C) a regional government of a Member State, as set out in the Schedule of the Union in Annex 19; or (D) a local government, other than that referred to in point (C); and (ii) for the United Kingdom: (A) the central government, as set out in the Schedule of the United Kingdom in Annex 19; (B) a regional government, as set out in the Schedule of the United Kingdom in Annex 19; or (C) a local government; (b) the continuation or prompt renewal of any non-conforming measure referred to in point (a) of this paragraph; or (c) a modification to any non-conforming measure referred to in points (a) and (b) of this paragraph to the extent that it does not decrease the conformity of the measure, as it existed immediately before the modification, with Article 194. 2. Article 194 does not apply to any measure of a Party which is consistent with the reservations, conditions or qualifications specified with respect to a sector, subsector or activity listed in Annex 20. 3. This Section applies without prejudice to Annex 22. TITLE III DIGITAL TRADE CHAPTER 1 GENERAL PROVISIONS Article 196 Objective The objective of this Title is to facilitate digital trade, to address unjustified barriers to trade enabled by electronic means and to ensure an open, secure and trustworthy online environment for businesses and consumers. Article 197 Scope 1. This Title applies to measures of a Party affecting trade enabled by electronic means. 2. This Title does not apply to audio-visual services. Article 198 Right to regulate The Parties reaffirm the right to regulate within their territories to achieve legitimate policy objectives, such as the protection of public health, social services, public education, safety, the environment including climate change, public morals, social or consumer protection, privacy and data protection, or the promotion and protection of cultural diversity. Article 199 Exceptions For greater certainty, nothing in this Title prevents the Parties from adopting or maintaining measures in accordance with Articles 184, 412 and 415 for the public interest reasons set out therein. Article 200 Definitions 1. The definitions in Article 124 apply to this Title. 2. For the purposes of this Title, the following definitions apply: (a) "consumer" means any natural person using a public telecommunications service for other than professional purposes; (b) "direct marketing communication" means any form of commercial advertising by which a natural or legal person communicates marketing messages directly to a user via a public telecommunications service and covers at least electronic mail and text and multimedia messages (SMS and MMS); (c) "electronic authentication" means an electronic process that enables the confirmation of: (i) the electronic identification of a natural or legal person, or (ii) the origin and integrity of data in electronic form; (d) "electronic registered delivery service" means a service that makes it possible to transmit data between third parties by electronic means and provides evidence relating to the handling of the transmitted data, including proof of sending and receiving the data, and that protects transmitted data against the risk of loss, theft, damage or any unauthorised alterations; (e) "electronic seal" means data in electronic form used by a legal person which is attached to or logically associated with other data in electronic form to ensure the latter's origin and integrity; (f) "electronic signature" means data in electronic form which is attached to or logically associated with other data in electronic form that: (i) is used by a natural person to agree on the data in electronic form to which it relates; and (ii) is linked to the data in electronic form to which it relates in such a way that any subsequent alteration in the data is detectable; (g) "electronic time stamp" means data in electronic form which binds other data in electronic form to a particular time establishing evidence that the latter data existed at that time; (h) "electronic trust service" means an electronic service consisting of: (i) the creation, verification and validation of electronic signatures, electronic seals, electronic time stamps, electronic registered delivery services and certificates related to those services; (ii) the creation, verification and validation of certificates for website authentication; or (iii) the preservation of electronic signatures, seals or certificates related to those services; (i) "government data" means data owned or held by any level of government and by non-governmental bodies in the exercise of powers conferred on them by any level of government; (j) "public telecommunications service" means any telecommunications service that is offered to the public generally; (k) "user" means any natural or legal person using a public telecommunications service. CHAPTER 2 DATA FLOWS AND PERSONAL DATA PROTECTION Article 201 Cross-border data flows 1. The Parties are committed to ensuring cross-border data flows to facilitate trade in the digital economy. To that end, cross-border data flows shall not be restricted between the Parties by a Party: (a) requiring the use of computing facilities or network elements in the Party's territory for processing, including by imposing the use of computing facilities or network elements that are certified or approved in the territory of a Party; (b) requiring the localisation of data in the Party's territory for storage or processing; (c) prohibiting the storage or processing in the territory of the other Party; or (d) making the cross-border transfer of data contingent upon use of computing facilities or network elements in the Parties' territory or upon localisation requirements in the Parties' territory. 2. The Parties shall keep the implementation of this provision under review and assess its functioning within three years of the date of entry into force of this Agreement. A Party may at any time propose to the other Party to review the list of restrictions listed in paragraph 1. Such a request shall be accorded sympathetic consideration. Article 202 Protection of personal data and privacy 1. Each Party recognises that individuals have a right to the protection of personal data and privacy and that high standards in this regard contribute to trust in the digital economy and to the development of trade. 2. Nothing in this Agreement shall prevent a Party from adopting or maintaining measures on the protection of personal data and privacy, including with respect to cross-border data transfers, provided that the law of the Party provides for instruments enabling transfers under conditions of general application (34) for the protection of the data transferred. 3. Each Party shall inform the other Party about any measure referred to in paragraph 2 that it adopts or maintains. CHAPTER 3 SPECIFIC PROVISIONS Article 203 Customs duties on electronic transmissions 1. Electronic transmissions shall be considered as the supply of a service within the meaning of Title II of this Heading. 2. The Parties shall not impose customs duties on electronic transmissions. Article 204 No prior authorisation 1. A Party shall not require prior authorisation of the provision of a service by electronic means solely on the ground that the service is provided online, and shall not adopt or maintain any other requirement having an equivalent effect. A service is provided online when it is provided by electronic means and without the parties being simultaneously present. 2. Paragraph 1 does not apply to telecommunications services, broadcasting services, gambling services, legal representation services or to the services of notaries or equivalent professions to the extent that they involve a direct and specific connection with the exercise of public authority. Article 205 Conclusion of contracts by electronic means 1. Each Party shall ensure that contracts may be concluded by electronic means and that its law neither creates obstacles for the use of electronic contracts nor results in contracts being deprived of legal effect and validity solely on the ground that the contract has been made by electronic means. 2. Paragraph 1 does not apply to the following: (a) broadcasting services; (b) gambling services; (c) legal representation services; (d) the services of notaries or equivalent professions involving a direct and specific connection with the exercise of public authority; (e) contracts that require witnessing in person; (f) contracts that establish or transfer rights in real estate; (g) contracts requiring by law the involvement of courts, public authorities or professions exercising public authority; (h) contracts of suretyship granted, collateral securities furnished by persons acting for purposes outside their trade, business or profession; or (i) contracts governed by family law or by the law of succession. Article 206 Electronic authentication and electronic trust services 1. A Party shall not deny the legal effect and admissibility as evidence in legal proceedings of an electronic document, an electronic signature, an electronic seal or an electronic time stamp, or of data sent and received using an electronic registered delivery service, solely on the ground that it is in electronic form. 2. A Party shall not adopt or maintain measures that would: (a) prohibit parties to an electronic transaction from mutually determining the appropriate electronic authentication methods for their transaction; or (b) prevent parties to an electronic transaction from being able to prove to judicial and administrative authorities that the use of electronic authentication or an electronic trust service in that transaction complies with the applicable legal requirements. 3. Notwithstanding paragraph 2, a Party may require that for a particular category of transactions, the method of electronic authentication or trust service is certified by an authority accredited in accordance with its law or meets certain performance standards which shall be objective, transparent and non-discriminatory and only relate to the specific characteristics of the category of transactions concerned. Article 207 Transfer of or access to source code 1. A Party shall not require the transfer of, or access to, the source code of software owned by a natural or legal person of the other Party. 2. For greater certainty: (a) the general exceptions, security exceptions and prudential carve-out referred to in Article 199 apply to measures of a Party adopted or maintained in the context of a certification procedure; and (b) paragraph 1 of this Article does not apply to the voluntary transfer of, or granting of access to, source code on a commercial basis by a natural or legal person of the other Party, such as in the context of a public procurement transaction or a freely negotiated contract. 3. Nothing in this Article shall affect: (a) a requirement by a court or administrative tribunal, or a requirement by a competition authority pursuant to a Party's competition law to prevent or remedy a restriction or a distortion of competition; (b) a requirement by a regulatory body pursuant to a Party's laws or regulations related to the protection of public safety with regard to users online, subject to safeguards against unauthorised disclosure; (c) the protection and enforcement of intellectual property rights; and (d) the right of a Party to take measures in accordance with Article III of the GPA as incorporated by Article 277 of this Agreement. Article 208 Online consumer trust 1. Recognising the importance of enhancing consumer trust in digital trade, each Party shall adopt or maintain measures to ensure the effective protection of consumers engaging in electronic commerce transactions, including but not limited to measures that: (a) proscribe fraudulent and deceptive commercial practices; (b) require suppliers of goods and services to act in good faith and abide by fair commercial practices, including through the prohibition of charging consumers for unsolicited goods and services; (c) require suppliers of goods or services to provide consumers with clear and thorough information, including when they act through intermediary service suppliers, regarding their identity and contact details, the transaction concerned, including the main characteristics of the goods or services and the full price inclusive of all applicable charges, and the applicable consumer rights (in the case of intermediary service suppliers, this includes enabling the provision of such information by the supplier of goods or services); and (d) grant consumers access to redress for breaches of their rights, including a right to remedies if goods or services are paid for and are not delivered or provided as agreed. 2. The Parties recognise the importance of entrusting their consumer protection agencies or other relevant bodies with adequate enforcement powers and the importance of cooperation between these agencies in order to protect consumers and enhance online consumer trust. Article 209 Unsolicited direct marketing communications 1. Each Party shall ensure that users are effectively protected against unsolicited direct marketing communications. 2. Each Party shall ensure that direct marketing communications are not sent to users who are natural persons unless they have given their consent in accordance with each Party's laws to receiving such communications. 3. Notwithstanding paragraph 2, a Party shall allow natural or legal persons who have collected, in accordance with conditions laid down in the law of that Party, the contact details of a user in the context of the supply of goods or services, to send direct marketing communications to that user for their own similar goods or services. 4. Each Party shall ensure that direct marketing communications are clearly identifiable as such, clearly disclose on whose behalf they are made and contain the necessary information to enable users to request cessation free of charge and at any moment. 5. Each Party shall provide users with access to redress against suppliers of direct marketing communications that do not comply with the measures adopted or maintained pursuant to paragraphs 1 to 4. Article 210 Open government data 1. The Parties recognise that facilitating public access to, and use of, government data contributes to stimulating economic and social development, competitiveness, productivity and innovation. 2. To the extent that a Party chooses to make government data accessible to the public, it shall endeavour to ensure, to the extent practicable, that the data: (a) is in a format that allows it to be easily searched, retrieved, used, reused, and redistributed; (b) is in a machine-readable and spatially-enabled format; (c) contains descriptive metadata, which is as standard as possible; (d) is made available via reliable, user-friendly and freely available Application Programming Interfaces; (e) is regularly updated; (f) is not subject to use conditions that are discriminatory or that unnecessarily restrict re-use; and (g) is made available for re-use in full compliance with the Parties' respective personal data protection rules. 3. The Parties shall endeavour to cooperate to identify ways in which each Party can expand access to, and use of, government data that the Party has made public, with a view to enhancing and generating business opportunities, beyond its use by the public sector. Article 211 Cooperation on regulatory issues with regard to digital trade 1. The Parties shall exchange information on regulatory matters in the context of digital trade, which shall address the following: (a) the recognition and facilitation of interoperable electronic authentication and electronic trust services; (b) the treatment of direct marketing communications; (c) the protection of consumers; and (d) any other matter relevant for the development of digital trade, including emerging technologies. 2. Paragraph 1 shall not apply to a Party's rules and safeguards for the protection of personal data and privacy, including on cross-border transfers of personal data. Article 212 Understanding on computer services 1. The Parties agree that, for the purpose of liberalising trade in services and investment in accordance with Title II of this Heading, the following services shall be considered as computer and related services, regardless of whether they are delivered via a network, including the internet: (a) consulting, adaptation, strategy, analysis, planning, specification, design, development, installation, implementation, integration, testing, debugging, updating, support, technical assistance or management of or for computers or computer systems; (b) computer programmes defined as the sets of instructions required to make computers work and communicate (in and of themselves), as well as consulting, strategy, analysis, planning, specification, design, development, installation, implementation, integration, testing, debugging, updating, adaptation, maintenance, support, technical assistance, management or use of or for computer programmes; (c) data processing, data storage, data hosting or database services; (d) maintenance and repair services for office machinery and equipment, including computers; and (e) training services for staff of clients, related to computer programmes, computers or computer systems, and not elsewhere classified. 2. For greater certainty, services enabled by computer and related services, other than those listed in paragraph 1, shall not be regarded as computer and related services in themselves. TITLE IV CAPITAL MOVEMENTS, PAYMENTS, TRANSFERS AND TEMPORARY SAFEGUARD MEASURES Article 213 Objectives The objective of this Title is to enable the free movement of capital and payments related to transactions liberalised under this Agreement. Article 214 Current account Each Party shall allow, in freely convertible currency and in accordance with the Articles of Agreement of the International Monetary Fund, any payments and transfers with respect to transactions on the current account of the balance of payments that fall within the scope of this Agreement. Article 215 Capital movements 1. Each Party shall allow, with regard to transactions on the capital and financial account of the balance of payments, the free movement of capital for the purpose of liberalisation of investment and other transactions as provided for in Title II of this Heading. 2. The Parties shall consult each other in the Trade Specialised Committee on Services, Investment and Digital Trade to facilitate the movement of capital between them in order to promote trade and investment. Article 216 Measures affecting capital movements, payments or transfers 1. Articles 214 and 215 shall not be construed as preventing a Party from applying its laws and regulations relating to: (a) bankruptcy, insolvency, or the protection of the rights of creditors; (b) issuing, trading or dealing in securities, or futures, options and other financial instruments; (c) financial reporting or record keeping of capital movements, payments or transfers where necessary to assist law enforcement or financial regulatory authorities; (d) criminal or penal offences, deceptive or fraudulent practices; (e) ensuring compliance with orders or judgments in judicial or administrative proceedings; or (f) social security, public retirement or compulsory savings schemes. 2. The laws and regulations referred to in paragraph 1 shall not be applied in an arbitrary or discriminatory manner, or otherwise constitute a disguised restriction on capital movements, payments or transfers. Article 217 Temporary safeguard measures 1. In exceptional circumstances of serious difficulties for the operation of the Union's economic and monetary union, or threat thereof, the Union may adopt or maintain safeguard measures with regard to capital movements, payments or transfers for a period not exceeding six months. 2. The measures referred to in paragraph 1 shall be limited to the extent that is strictly necessary. Article 218 Restrictions in case of balance of payments and external financial difficulties 1. If a Party experiences serious balance of payments or external financial difficulties, or threat thereof, it may adopt or maintain restrictive measures with regard to capital movements, payments or transfers (35). 2. The measures referred to in paragraph 1 shall: (a) be consistent with the Articles of Agreement of the International Monetary Fund; (b) not exceed those necessary to deal with the circumstances described in paragraph 1; (c) be temporary and be phased out progressively as the situation specified in paragraph 1 improves; (d) avoid unnecessary damage to the commercial, economic and financial interests of the other Party; and (e) be non-discriminatory as compared with third countries in like situations. 3. In the case of trade in goods, each Party may adopt or maintain restrictive measures in order to safeguard its external financial position or balance of payments. Those measures shall be in accordance with GATT 1994 and the Understanding on the Balance of Payments provisions of the General Agreement on Tariffs and Trade 1994. 4. In the case of trade in services, each Party may adopt or maintain restrictive measures in order to safeguard its external financial position or balance of payments. Those measures shall be in accordance with Article XII of GATS. 5. A Party maintaining or having adopted measures referred to in paragraphs 1 and 2 shall promptly notify them to the other Party. 6. If a Party adopts or maintains restrictions under this Article, the Parties shall promptly hold consultations in the Trade Specialised Committee on Services, Investment and Digital Trade unless consultations are held in other fora. That Committee shall assess the balance of payments or external financial difficulties that led to the respective measures, taking into account factors such as: (a) the nature and extent of the difficulties; (b) the external economic and trading environment; and (c) alternative corrective measures which may be available. 7. The consultations under paragraph 6 shall address the compliance of any restrictive measures with paragraphs 1 and 2. All relevant findings of a statistical or factual nature presented by the International Monetary Fund, where available, shall be accepted and conclusions shall take into account the assessment by the International Monetary Fund of the balance of payments and the external financial situation of the Party concerned. TITLE V INTELLECTUAL PROPERTY CHAPTER 1 GENERAL PROVISIONS Article 219 Objectives The objectives of this Title are to: (a) facilitate the production, provision and commercialisation of innovative and creative products and services between the Parties by reducing distortions and impediments to such trade, thereby contributing to a more sustainable and inclusive economy; and (b) ensure an adequate and effective level of protection and enforcement of intellectual property rights. Article 220 Scope 1. This Title shall complement and further specify the rights and obligations of each Party under the TRIPS Agreement and other international treaties in the field of intellectual property to which they are parties. 2. This Title does not preclude either Party from introducing more extensive protection and enforcement of intellectual property rights than required under this Title, provided that such protection and enforcement does not contravene this Title. Article 221 Definitions For the purposes of this Title, the following definitions apply: (a) "Paris Convention" means the Paris Convention for the Protection of Industrial Property of 20 March 1883, as last revised at Stockholm on 14 July 1967; (b) "Berne Convention" means the Berne Convention for the Protection of Literary and Artistic Works of 9 September 1886 revised at Paris on 24 July 1971 and amended on 28 September 1979; (c) "Rome Convention" means the International Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organisations done at Rome on 26 October 1961; (d) "WIPO" means the World Intellectual Property Organisation; (e) "intellectual property rights" means all categories of intellectual property that are covered by Articles 225 to 255 of this Agreement or Sections 1 to 7 of Part II of the TRIPS Agreement. The protection of intellectual property includes protection against unfair competition as referred to in Article 10bis of the Paris Convention; (f) "national" means, in respect of the relevant intellectual property right, a person of a Party that would meet the criteria for eligibility for protection provided for in the TRIPS Agreement and multilateral agreements concluded and administered under the auspices of WIPO, to which a Party is a contracting party. Article 222 International agreements 1. The Parties affirm their commitment to comply with the international agreements to which they are party: (a) the TRIPS Agreement; (b) the Rome Convention; (c) the Berne Convention; (d) the WIPO Copyright Treaty, adopted at Geneva on 20 December 1996; (e) the WIPO Performances and Phonograms Treaty, adopted at Geneva on 20 December 1996; (f) the Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks, adopted at Madrid on 27 June 1989, as last amended on 12 November 2007; (g) the Trademark Law Treaty, adopted at Geneva on 27 October 1994; (h) the Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired or Otherwise Print Disabled, adopted at Marrakesh on 27 June 2013; (i) the Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs, adopted at Geneva on 2 July 1999. 2. Each Party shall make all reasonable efforts to ratify or accede to the following international agreements: (a) the Beijing Treaty on Audiovisual Performances, adopted at Beijing on 24 June 2012; (b) the Singapore Treaty on the Law of Trademarks adopted at Singapore on 27 March 2006. Article 223 Exhaustion This Title does not affect the freedom of the parties to determine whether and under what conditions the exhaustion of intellectual property rights applies. Article 224 National treatment 1. In respect of all categories of intellectual property covered by this Title, each Party shall accord to the nationals of the other Party treatment no less favourable than the treatment it accords to its own nationals with regard to the protection of intellectual property subject where applicable to the exceptions already provided for in, respectively, the Paris Convention, the Berne Convention, the Rome Convention and the Treaty on Intellectual Property in Respect of Integrated Circuits, done at Washington on 26 May 1989. In respect of performers, producers of phonograms and broadcasting organisations, this obligation only applies in respect of the rights provided for under this Agreement. 2. For the purposes of paragraph 1 of this Article, "protection" shall include matters affecting the availability, acquisition, scope, maintenance, and enforcement of intellectual property rights as well as matters affecting the use of intellectual property rights specifically addressed in this Title, including measures to prevent the circumvention of effective technological measures as referred to in Article 234 and measures concerning rights management information as referred to in Article 235. 3. A Party may avail itself of the exceptions permitted pursuant to paragraph 1 in relation to its judicial and administrative procedures, including requiring a national of the other Party to designate an address for service in its territory, or to appoint an agent in its territory, if such exceptions are: (a) necessary to secure compliance with the Party's laws or regulations which are not inconsistent with this Title; or (b) not applied in a manner which would constitute a disguised restriction on trade. 4. Paragraph 1 does not apply to procedures provided in multilateral agreements concluded under the auspices of WIPO relating to the acquisition or maintenance of intellectual property rights. CHAPTER 2 STANDARDS CONCERNING INTELLECTUAL PROPERTY RIGHTS SECTION 1 COPYRIGHT AND RELATED RIGHTS Article 225 Authors Each Party shall provide authors with the exclusive right to authorise or prohibit: (a) direct or indirect, temporary or permanent reproduction by any means and in any form, in whole or in part, of their works; (b) any form of distribution to the public by sale or otherwise of the original of their works or of copies thereof; (c) any communication to the public of their works by wire or wireless means, including the making available to the public of their works in such a way that members of the public may access them from a place and at a time individually chosen by them; (d) the commercial rental to the public of originals or copies of their works; each Party may provide that this point does not apply to buildings or works of applied art. Article 226 Performers Each Party shall provide performers with the exclusive right to authorise or prohibit: (a) the fixation of their performances; (b) the direct or indirect, temporary or permanent reproduction by any means and in any form, in whole or in part, of fixations of their performances; (c) the distribution to the public, by sale or otherwise, of the fixations of their performances; (d) the making available to the public of fixations of their performances, by wire or wireless means, in such a way that members of the public may access them from a place and at a time individually chosen by them; (e) the broadcasting by wireless means and the communication to the public of their performances, except where the performance is itself already a broadcast performance or is made from a fixation; (f) the commercial rental to the public of the fixation of their performances. Article 227 Producers of phonograms Each Party shall provide phonogram producers with the exclusive right to authorise or prohibit: (a) the direct or indirect, temporary or permanent, reproduction by any means and in any form, in whole or in part, of their phonograms; (b) the distribution to the public, by sale or otherwise, of their phonograms, including copies thereof; (c) the making available to the public of their phonograms, by wire or wireless means, in such a way that members of the public may access them from a place and at a time individually chosen by them; (d) the commercial rental of their phonograms to the public. Article 228 Broadcasting organisations Each Party shall provide broadcasting organisations with the exclusive right to authorise or prohibit: (a) the fixation of their broadcasts, whether these broadcasts are transmitted by wire or over the air, including by cable or satellite; (b) the direct or indirect, temporary or permanent reproduction by any means and in any form, in whole or in part, of fixations of their broadcasts, whether those broadcasts are transmitted by wire or over the air, including by cable or satellite; (c) the making available to the public, by wire or wireless means, of fixations of their broadcasts, whether those broadcasts are transmitted by wire or over the air, including by cable or satellite, in such a way that members of the public may access them from a place and at a time individually chosen by them; (d) the distribution to the public, by sale or otherwise, of fixations, including copies thereof, of their broadcasts, whether these broadcasts are transmitted by wire or over the air, including by cable or satellite; (e) the rebroadcasting of their broadcasts by wireless means, as well as the communication to the public of their broadcasts if such communication is made in places accessible to the public against payment of an entrance fee. Article 229 Broadcasting and communication to the public of phonograms published for commercial purposes 1. Each Party shall provide a right in order to ensure that a single equitable remuneration is paid by the user to the performers and producers of phonograms, if a phonogram published for commercial purposes, or a reproduction of such phonogram, is used for broadcasting or any communication to the public. 2. Each Party shall ensure that the single equitable remuneration is shared between the relevant performers and phonogram producers. Each Party may enact legislation that, in the absence of an agreement between performers and producers of phonograms, sets the terms according to which performers and producers of phonograms shall share the single equitable remuneration. 3. Each Party may grant more extensive rights, as regards the broadcasting and communication to the public of phonograms published for commercial purposes, to performers and producers of phonograms. Article 230 Term of protection 1. The rights of an author of a work shall run for the life of the author and for 70 years after the author's death, irrespective of the date when the work is lawfully made available to the public. 2. For the purpose of implementing paragraph 1, each Party may provide for specific rules on the calculation of the term of protection of musical composition with words, works of joint authorship as well as cinematographic or audiovisual works. Each Party may provide for specific rules on the calculation of the term of protection of anonymous or pseudonymous works. 3. The rights of broadcasting organisations shall expire 50 years after the first transmission of a broadcast, whether this broadcast is transmitted by wire or over the air, including by cable or satellite. 4. The rights of performers for their performances otherwise than in phonograms shall expire 50 years after the date of the fixation of the performance or, if lawfully published or lawfully communicated to the public during this time, 50 years from the first such publication or communication to the public, whichever is the earlier. 5. The rights of performers for their performances fixed in phonograms shall expire 50 years after the date of fixation of the performance or, if lawfully published or lawfully communicated to the public during this time, 70 years from such act, whichever is the earlier. 6. The rights of producers of phonograms shall expire 50 years after the fixation is made or, if lawfully published to the public during this time, 70 years from such publication. In the absence of a lawful publication, if the phonogram has been lawfully communicated to the public during this time, the term of protection shall be 70 years from such act of communication. Each Party may provide for effective measures in order to ensure that the profit generated during the 20 years of protection beyond 50 years is shared fairly between the performers and the producers of phonograms. 7. The terms laid down in this Article shall be counted from the first of January of the year following the year of the event which gives rise to them. 8. Each Party may provide for longer terms of protection than those provided for in this Article. Article 231 Resale right 1. Each Party shall provide, for the benefit of the author of an original work of graphic or plastic art, a resale right, to be defined as an inalienable right, which cannot be waived, even in advance, to receive a royalty based on the sale price obtained for any resale of the work, subsequent to the first transfer of the work by the author. 2. The right referred to in paragraph 1 shall apply to all acts of resale involving as sellers, buyers or intermediaries art market professionals, such as salesrooms, art galleries and, in general, any dealers in works of art. 3. Each Party may provide that the right referred to in paragraph 1 shall not apply to acts of resale, where the seller has acquired the work directly from the author less than three years before that resale and where the resale price does not exceed a certain minimum amount. 4. The procedure for collection of the remuneration and their amounts shall be determined by the law of each Party. Article 232 Collective management of rights 1. The Parties shall promote cooperation between their respective collective management organisations for the purpose of fostering the availability of works and other protected subject matter in their respective territories and the transfer of rights revenue between the respective collective management organisations for the use of such works or other protected subject matter. 2. The Parties shall promote the transparency of collective management organisations, in particular regarding the rights revenue they collect, the deductions they apply to the rights revenue they collect, the use of the rights revenue collected, the distribution policy and their repertoire. 3. The Parties shall endeavour to facilitate arrangements between their respective collective management organisations on non-discriminatory treatment of right holders whose rights these organisations manage under representation agreements. 4. The Parties shall cooperate to support the collective management organisations established in their territory and representing another collective management organisation established in the territory of the other Party by way of a representation agreement with a view to ensuring that they accurately, regularly and diligently pay amounts owed to the represented collective management organisations and provide the represented collective management organisation with the information on the amount of rights revenue collected on its behalf and any deductions made to that rights revenue. Article 233 Exceptions and limitations Each Party shall confine limitations or exceptions to the rights set out in Articles 225 to 229 to certain special cases which do not conflict with a normal exploitation of the work or other subject-matter and do not unreasonably prejudice the legitimate interests of the right holders. Article 234 Protection of technological measures 1. Each Party shall provide adequate legal protection against the circumvention of any effective technological measures, which the person concerned carries out in the knowledge, or with reasonable grounds to know, that he or she is pursuing that objective. Each Party may provide for a specific regime for legal protection of technological measures used to protect computer programs. 2. Each Party shall provide adequate legal protection against the manufacture, import, distribution, sale, rental, advertisement for sale or rental, or possession for commercial purposes of devices, products or components or the provision of services which: (a) are promoted, advertised or marketed for the purpose of circumvention of; (b) have only a limited commercially significant purpose or use other than to circumvent; or (c) are primarily designed, produced, adapted or performed for the purpose of enabling or facilitating the circumvention of, any effective technological measures. 3. For the purposes of this Section, the expression "technological measures" means any technology, device or component that, in the normal course of its operation, is designed to prevent or restrict acts, in respect of works or other subject-matter, which are not authorised by the right holder of any copyright or related right covered by this Section. Technological measures shall be deemed "effective" where the use of a protected work or other subject matter is controlled by the right holders through application of an access control or protection process, such as encryption, scrambling or other transformation of the work or other subject-matter or a copy control mechanism, which achieves the protection objective. 4. Notwithstanding the legal protection provided for in paragraph 1 of this Article, each Party may take appropriate measures, as necessary, to ensure that the adequate legal protection against the circumvention of effective technological measures provided for in accordance with this Article does not prevent beneficiaries of exceptions or limitations provided for in accordance with Article 233 from enjoying such exceptions or limitations. Article 235 Obligations concerning rights management information 1. Each Party shall provide adequate legal protection against any person knowingly performing without authority any of the following acts: (a) the removal or alteration of any electronic rights-management information; (b) the distribution, importation for distribution, broadcasting, communication or making available to the public of works or other subject-matter protected pursuant to this Section from which electronic rights-management information has been removed or altered without authority; if such person knows, or has reasonable grounds to know, that by so doing he or she is inducing, enabling, facilitating or concealing an infringement of any copyright or any related rights as provided by the law of a Party. 2. For the purposes of this Article, "rights-management information" means any information provided by right holders which identifies the work or other subject-matter referred to in this Article, the author or any other right holder, or information about the terms and conditions of use of the work or other subject-matter, and any numbers or codes that represent such information. 3. Paragraph 2 applies if any of these items of information is associated with a copy of, or appears in connection with the communication to the public of, a work or other subject-matter referred to in this Article. SECTION 2 TRADE MARKS Article 236 Trade mark classification Each Party shall maintain a trade mark classification system that is consistent with the Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks of 15 June 1957, as amended and revised. Article 237 Signs of which a trade mark may consist A trade mark may consist of any signs, in particular words, including personal names, or designs, letters, numerals, colours, the shape of goods or of the packaging of goods, or sounds, provided that such signs are capable of: (a) distinguishing the goods or services of one undertaking from those of other undertakings; and (b) being represented on the respective trade mark register of each Party, in a manner which enables the competent authorities and the public to determine the clear and precise subject matter of the protection afforded to its proprietor. Article 238 Rights conferred by a trade mark 1. Each Party shall provide that the registration of a trade mark confers on the proprietor exclusive rights therein. The proprietor shall be entitled to prevent all third parties not having the proprietor's consent from using in the course of trade: (a) any sign which is identical with the registered trade mark in relation to goods or services which are identical with those for which the trade mark is registered; (b) any sign where, because of its identity with, or similarity to, the registered trade mark and the identity or similarity of the goods or services covered by this trade mark and the sign, there exists a likelihood of confusion on the part of the public, including the likelihood of association between the sign and the registered trade mark. 2. The proprietor of a registered trade mark shall be entitled to prevent all third parties from bringing goods, in the course of trade, into the Party where the trade mark is registered without being released for free circulation there, where such goods, including packaging, come from other countries or the other Party and bear without authorisation a trade mark which is identical to the trade mark registered in respect of such goods, or which cannot be distinguished in its essential aspects from that trade mark. 3. The entitlement of the proprietor of a trade mark pursuant to paragraph 2 shall lapse if during the proceedings to determine whether the registered trade mark has been infringed, evidence is provided by the declarant or the holder of the goods that the proprietor of the registered trade mark is not entitled to prohibit the placing of the goods on the market in the country of final destination. Article 239 Registration procedure 1. Each Party shall provide for a system for the registration of trade marks in which each final negative decision taken by the relevant trade mark administration, including partial refusals of registration, shall be communicated in writing to the relevant party, duly reasoned and subject to appeal. 2. Each Party shall provide for the possibility for third parties to oppose trade mark applications or, where appropriate, trade mark registrations. Such opposition proceedings shall be adversarial. 3. Each Party shall provide a publicly available electronic database of trade mark applications and trade mark registrations. 4. Each Party shall make best efforts to provide a system for the electronic application for and processing, registration and maintenance of trade marks. Article 240 Well-known trade marks For the purpose of giving effect to protection of well-known trade marks, as referred to in Article 6bis of the Paris Convention and Article 16(2) and (3) of the TRIPS Agreement, each Party shall apply the Joint Recommendation Concerning Provisions on the Protection of Well-Known Marks, adopted by the Assembly of the Paris Union for the Protection of Industrial Property and the General Assembly of the WIPO at the Thirty-Fourth Series of Meetings of the Assemblies of the Member States of WIPO on 20 to 29 September 1999. Article 241 Exceptions to the rights conferred by a trade mark 1. Each Party shall provide for limited exceptions to the rights conferred by a trade mark such as the fair use of descriptive terms including geographical indications, and may provide other limited exceptions, provided such exceptions take account of the legitimate interests of the proprietor of the trade mark and of third parties. 2. The trade mark shall not entitle the proprietor to prohibit a third party from using, in the course of trade: (a) the name or address of the third party, where the third party is a natural person; (b) signs or indications concerning the kind, quality, quantity, intended purpose, value, geographical origin, the time of production of goods or of rendering of the service, or other characteristics of goods or services; or (c) the trade mark for the purpose of identifying or referring to goods or services as those of the proprietor of that trade mark, in particular where the use of that trade mark is necessary to indicate the intended purpose of a product or service, in particular as accessories or spare parts, provided the third party uses them in accordance with honest practices in industrial or commercial matters. 3. The trade mark shall not entitle the proprietor to prohibit a third party from using, in the course of trade, an earlier right which only applies in a particular locality if that right is recognised by the laws of the Party in question and is used within the limits of the territory in which it is recognised. Article 242 Grounds for revocation 1. Each Party shall provide that a trade mark shall be liable to revocation if, within a continuous period of five years it has not been put to genuine use in the relevant territory of a Party by the proprietor or with the proprietor's consent in relation to the goods or services for which it is registered, and there are no proper reasons for non-use. 2. Each Party shall also provide that a trade mark shall be liable to revocation if within the period of five years following the date of completion of the registration procedure it has not been put to genuine use in the relevant territory by the proprietor or with the proprietor's consent, in relation to the goods or services for which it is registered, and there are no proper reasons for non-use. 3. However, no person may claim that the proprietor's rights in a trade mark should be revoked where, during the interval between expiry of the five-year period and filing of the application for revocation, genuine use of the trade mark has been started or resumed. The commencement or resumption of use within a period of three months preceding the filing of the application for revocation which began at the earliest on expiry of the continuous period of five years of non-use, shall, however, be disregarded where preparations for the commencement or resumption occur only after the proprietor becomes aware that the application for revocation may be filed. 4. A trade mark shall also be liable to revocation if, after the date on which it was registered: (a) as a consequence of acts or inactivity of the proprietor, it has become the common name in the trade for a good or service in respect of which it is registered; (b) as a consequence of the use made of the trade mark by the proprietor of the trade mark or with the proprietor's consent in respect of the goods or services for which it is registered, it is liable to mislead the public, particularly as to the nature, quality or geographical origin of those goods or services. Article 243 The right to prohibit preparatory acts in relation to the use of packaging or other means Where the risk exists that the packaging, labels, tags, security or authenticity features or devices, or any other means to which the trade mark is affixed could be used in relation to goods or services and that use would constitute an infringement of the rights of the proprietor of the trade mark, the proprietor of that trade mark shall have the right to prohibit the following acts if carried out in the course of trade: (a) affixing a sign identical with, or similar to, the trade mark on packaging, labels, tags, security or authenticity features or devices, or any other means to which the mark may be affixed; or (b) offering or placing on the market, or stocking for those purposes, or importing or exporting, packaging, labels, tags, security or authenticity features or devices, or any other means to which the mark is affixed. Article 244 Bad faith applications A trade mark shall be liable to be declared invalid where the application for registration of the trade mark was made in bad faith by the applicant. Each Party may provide that such a trade mark shall not be registered. SECTION 3 DESIGN Article 245 Protection of registered designs 1. Each Party shall provide for the protection of independently created designs that are new and original. This protection shall be provided by registration and shall confer exclusive rights upon their holders in accordance with this Section. For the purposes of this Article, a Party may consider that a design having individual character is original. 2. The holder of a registered design shall have the right to prevent third parties not having the holder's consent at least from making, offering for sale, selling, importing, exporting, stocking the product bearing and embodying the protected design or using articles bearing or embodying the protected design where such acts are undertaken for commercial purposes. 3. A design applied to or incorporated in a product which constitutes a component part of a complex product shall only be considered to be new and original: (a) if the component part, once it has been incorporated into the complex product, remains visible during normal use of the latter; and (b) to the extent that those visible features of the component part fulfil in themselves the requirements as to novelty and originality. 4. For the purposes of point (a) of paragraph 3, "normal use" means use by the end user, excluding maintenance, servicing or repair work. Article 246 Duration of protection The duration of protection available for registered designs, including renewals of registered designs, shall amount to a total term of 25 years from the date on which the application was filed (36). Article 247 Protection of unregistered designs 1. Each Party shall confer on holders of an unregistered design the right to prevent the use of the unregistered design by any third party not having the holder's consent only if the contested use results from copying the unregistered design in their respective territory (37). Such use shall at least cover the offering for sale, putting on the market, importing or exporting the product. 2. The duration of protection available for the unregistered design shall amount to at least three years as from the date on which the design was first made available to the public in the territory of the respective Party. Article 248 Exceptions and exclusions 1. Each Party may provide limited exceptions to the protection of designs, including unregistered designs, provided that such exceptions do not unreasonably conflict with the normal exploitation of designs, and do not unreasonably prejudice the legitimate interests of the holder of the design, taking account of the legitimate interests of third parties. 2. Protection shall not extend to designs solely dictated by technical or functional considerations. A design shall not subsist in features of appearance of a product which must necessarily be reproduced in their exact form and dimensions in order to permit the product in which the design is incorporated or to which it is applied to be mechanically connected to or placed in, around or against another product so that either product may perform its function. 3. By way of derogation from paragraph 2 of this Article, a design shall, in accordance with the conditions set out in Article 245(1), subsist in a design, which has the purpose of allowing the multiple assembly or connection of mutually interchangeable products within a modular system. Article 249 Relationship to copyright Each Party shall ensure that designs, including unregistered designs, shall also be eligible for protection under the copyright law of that Party as from the date on which the design was created or fixed in any form. The extent to which, and the conditions under which, such a protection is conferred, including the level of originality required, shall be determined by each Party. SECTION 4 PATENTS Article 250 Patents and public health 1. The Parties recognise the importance of the Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001 by the Ministerial Conference of the WTO at Doha (the "Doha Declaration"). In interpreting and implementing the rights and obligations under this Section, each Party shall ensure consistency with the Doha Declaration. 2. Each Party shall implement Article 31bis of the TRIPS Agreement, as well as the Annex to the TRIPS Agreement and the Appendix to the Annex to the TRIPS Agreement. Article 251 Extension of the period of protection conferred by a patent on medicinal products and on plant protection products 1. The Parties recognise that medicinal products and plant protection products (38) protected by a patent in their respective territory may be subject to an administrative authorisation procedure before being put on their respective markets. The Parties recognise that the period that elapses between the filing of the application for a patent and the first authorisation to place the product on the market, as defined for that purpose by the relevant legislation, may shorten the period of effective protection under the patent. 2. Each Party shall provide for further protection, in accordance with its laws and regulations, for a product which is protected by a patent and which has been subject to an administrative authorisation procedure referred to in paragraph 1 to compensate the holder of a patent for the reduction of effective patent protection. The terms and conditions for the provision of such further protection, including its length, shall be determined in accordance with the laws and regulations of the Parties. 3. For the purposes of this Title, "medicinal product" means: (a) any substance or combination of substances presented as having properties for treating or preventing disease in human beings or animals; or (b) any substance or combination of substances which may be used in or administered to human beings or animals either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. SECTION 5 PROTECTION OF UNDISCLOSED INFORMATION Article 252 Protection of trade secrets 1. Each Party shall provide for appropriate civil judicial procedures and remedies for any trade secret holder to prevent, and obtain redress for, the acquisition, use or disclosure of a trade secret whenever carried out in a manner contrary to honest commercial practices. 2. For the purposes of this Section, the following definitions apply: (a) "trade secret" means information which meets all of the following requirements: (i) it is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question; (ii) it has commercial value because it is secret; and (iii) it has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret; (b) "trade secret holder" means any natural or legal person lawfully controlling a trade secret. 3. For the purposes of this Section, at least the following conduct shall be considered contrary to honest commercial practices: (a) the acquisition of a trade secret without the consent of the trade secret holder, whenever obtained by unauthorised access to, or by appropriation or copying of, any documents, objects, materials, substances or electronic files that are lawfully under the control of the trade secret holder, and that contain the trade secret or from which the trade secret can be deduced; (b) the use or disclosure of a trade secret whenever it is carried out, without the consent of the trade secret holder, by a person who is found to meet any of the following conditions: (i) having acquired the trade secret in a manner referred to in point (a); (ii) being in breach of a confidentiality agreement or any other duty not to disclose the trade secret; or (iii) being in breach of a contractual or any other duty to limit the use of the trade secret; (c) the acquisition, use or disclosure of a trade secret whenever carried out by a person who, at the time of the acquisition, use or disclosure, knew, or ought to have known, under the circumstances that the trade secret had been obtained directly or indirectly from another person who was using or disclosing the trade secret unlawfully within the meaning of point (b). 4. Nothing in this Section shall be understood as requiring either Party to consider any of the following conducts as contrary to honest commercial practices: (a) independent discovery or creation; (b) the reverse engineering of a product that has been made available to the public or that is lawfully in the possession of the acquirer of the information, where the acquirer of the information is free from any legally valid duty to limit the acquisition of the trade secret; (c) the acquisition, use or disclosure of a trade secret required or allowed by the law of each Party; (d) the exercise of the right of workers or workers' representatives to information and consultation in accordance with the laws and regulations of that Party. 5. Nothing in this Section shall be understood as affecting the exercise of freedom of expression and information, including the freedom and pluralism of the media, as protected in each Party, restricting the mobility of employees, or as affecting the autonomy of social partners and their right to enter into collective agreements, in accordance with the laws and regulations of the Parties. Article 253 Protection of data submitted to obtain an authorisation to put a medicinal product on the market 1. Each Party shall protect commercially confidential information submitted to obtain an authorisation to place medicinal products on the market ("marketing authorisation") against disclosure to third parties, unless steps are taken to ensure that the data are protected against unfair commercial use or except where the disclosure is necessary for an overriding public interest. 2. Each Party shall ensure that for a limited period of time to be determined by its domestic law and in accordance with any conditions set out in its domestic law, the authority responsible for the granting of a marketing authorisation does not accept any subsequent application for a marketing authorisation that relies on the results of pre-clinical tests or clinical trials submitted in the application to that authority for the first marketing authorisation, without the explicit consent of the holder of the first marketing authorisation, unless international agreements to which the Parties are both party provide otherwise. 3. Each Party shall also ensure that, for a limited period of time to be determined by its domestic law and in accordance with any conditions set out in its domestic law, a medicinal product subsequently authorised by that authority on the basis of the results of the pre-clinical tests and clinical trials referred to in paragraph 2 is not placed on the market without the explicit consent of the holder of the first marketing authorisation, unless international agreements to which the Parties are both party provide otherwise. 4. This Article is without prejudice to additional periods of protection which each Party may provide in that Party's law. Article 254 Protection of data submitted to obtain marketing authorisation for plant protection products or biocidal products 1. Each Party shall recognise a temporary right of the owner of a test or study report submitted for the first time to obtain a marketing authorisation concerning safety and efficacy of an active substance, plant protection product or biocidal product. During such period, the test or study report shall not be used for the benefit of any other person who seeks to obtain a marketing authorisation for an active substance, plant protection product or biocidal product, unless the explicit consent of the first owner has been proved. For the purposes of this Article, that right is referred to as data protection. 2. The test or study report submitted for marketing authorisation of an active substance or plant protection product should fulfil the following conditions: (a) be necessary for the authorisation or for an amendment of an authorisation in order to allow the use on other crops; and (b) be certified as compliant with the principles of good laboratory practice or of good experimental practice. 3. The period of data protection shall be at least 10 years from the grant of the first authorisation by a relevant authority in the territory of the Party. 4. Each Party shall ensure that the public bodies responsible for the granting of a marketing authorisation will not use the information referred to in paragraphs 1 and 2 for the benefit of a subsequent applicant for any successive marketing authorisation, regardless whether or not it has been made available to the public. 5. Each Party shall establish rules to avoid duplicative testing on vertebrate animals. SECTION 6 PLANT VARIETIES Article 255 Protection of plant varieties rights Each Party shall protect plant varieties rights in accordance with the International Convention for the Protection of New Varieties of Plants (UPOV) as lastly revised in Geneva on 19 March 1991. The Parties shall cooperate to promote and enforce these rights. CHAPTER 3 ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS SECTION 1 GENERAL PROVISIONS Article 256 General obligations 1. Each Party shall provide under its respective law for the measures, procedures and remedies necessary to ensure the enforcement of intellectual property rights. For the purposes of Sections 1, 2 and 4 of this Chapter, the term "intellectual property rights" does not include rights covered by Section 5 of Chapter 2. 2. The measures, procedures and remedies referred to in paragraph 1 shall: (a) be fair and equitable; (b) not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays; (c) be effective, proportionate and dissuasive; (d) be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse. Article 257 Persons entitled to apply for the application of the measures, procedures and remedies Each Party shall recognise as persons entitled to seek application of the measures, procedures and remedies referred to in Sections 2 and 4 of this Chapter: (a) the holders of intellectual property rights in accordance with the law of a Party; (b) all other persons authorised to use those rights, in particular licensees, in so far as permitted by and in accordance with the law of a Party; and (c) federations and associations (39), in so far as permitted by and in accordance with the law of a Party. SECTION 2 CIVIL AND ADMINISTRATIVE ENFORCEMENT Article 258 Measures for preserving evidence 1. Each Party shall ensure that, even before the commencement of proceedings on the merits of the case, the competent judicial authorities may, on application by a party who has presented reasonably available evidence to support their claims that their intellectual property right has been infringed or is about to be infringed, order prompt and effective provisional measures to preserve relevant evidence in respect of the alleged infringement, subject to appropriate safeguards and the protection of confidential information. 2. Such measures may include the detailed description, with or without the taking of samples, or the physical seizure of the alleged infringing goods, and, in appropriate cases, the materials and implements used in the production and/or distribution of these goods and the documents relating thereto. Article 259 Evidence 1. Each Party shall take the measures necessary to enable the competent judicial authorities to order, on application by a party which has presented reasonably available evidence sufficient to support its claims and has, in substantiating those claims, specified evidence which lies in the control of the opposing party, that this evidence be produced by the opposing party, subject to the protection of confidential information. 2. Each Party shall also take the necessary measures to enable the competent judicial authorities to order, where appropriate, in cases of infringement of an intellectual property right committed on a commercial scale, under the same conditions as in paragraph 1, the communication of banking, financial or commercial documents under the control of the opposing party, subject to the protection of confidential information. Article 260 Right of information 1. Each Party shall ensure that, in the context of civil proceedings concerning an infringement of an intellectual property right and in response to a justified and proportionate request of the claimant, the competent judicial authorities may order the infringer or any other person to provide information on the origin and distribution networks of the goods or services which infringe an intellectual property right. 2. For the purposes of paragraph 1 "any other person" means a person who: (a) was found in possession of the infringing goods on a commercial scale; (b) was found to be using the infringing services on a commercial scale; (c) was found to be providing on a commercial scale services used in infringing activities; or (d) was indicated by the person referred to in point (a), (b) or (c), as being involved in the production, manufacture or distribution of the goods or the provision of the services. 3. The information referred to in paragraph 1 shall, as appropriate, comprise: (a) the names and addresses of the producers, manufacturers, distributors, suppliers and other previous holders of the goods or services, as well as the intended wholesalers and retailers; (b) information on the quantities produced, manufactured, delivered, received or ordered, as well as the price obtained for the goods or services in question. 4. Paragraphs 1 and 2 shall apply without prejudice to other laws of a Party which: (a) grant the right holder rights to receive fuller information; (b) govern the use in civil proceedings of the information communicated pursuant to this Article; (c) govern responsibility for misuse of the right of information; (d) afford an opportunity for refusing to provide information which would force the person referred to in paragraph 1 to admit their own participation or that of their close relatives in an infringement of an intellectual property right; (e) govern the protection of confidentiality of information sources or the processing of personal data. Article 261 Provisional and precautionary measures 1. Each Party shall ensure that its judicial authorities may, at the request of the applicant, issue against the alleged infringer an interlocutory injunction intended to prevent any imminent infringement of an intellectual property right, or to forbid, on a provisional basis and subject, where appropriate, to a recurring penalty payment where provided for by the law of that Party, the continuation of the alleged infringements of that right, or to make such continuation subject to the lodging of guarantees intended to ensure the compensation of the right holder. An interlocutory injunction may also be issued, under the same conditions, against an intermediary whose services are being used by a third party to infringe an intellectual property right. 2. Each Party shall ensure that its judicial authorities may, at the request of the applicant, order the seizure or delivery up of goods suspected of infringing an intellectual property right, so as to prevent their entry into or movement within the channels of commerce. 3. In the case of an alleged infringement committed on a commercial scale, each Party shall ensure that, if the applicant demonstrates circumstances likely to endanger the recovery of damages, the judicial authorities may order the precautionary seizure of the movable and immovable property of the alleged infringer, including the blocking of their bank accounts and other assets. To that end, the competent authorities may order the communication of bank, financial or commercial documents, or appropriate access to the relevant information. 4. Each Party shall ensure that its judicial authorities shall, in respect of the measures referred to in paragraphs 1, 2 and 3, have the authority to require the applicant to provide any reasonably available evidence in order to satisfy themselves with a sufficient degree of certainty that the applicant is the right holder and that the applicant's right is being infringed, or that such infringement is imminent. Article 262 Corrective measures 1. Each Party shall ensure that its judicial authorities may order, at the request of the applicant, without prejudice to any damages due to the right holder by reason of the infringement, and without compensation of any sort, the destruction of goods that they have found to be infringing an intellectual property right or at least the definitive removal of those goods from the channels of commerce. If appropriate, under the same conditions, the judicial authorities may also order destruction of materials and implements predominantly used in the creation or manufacture of those goods. 2. Each Party's judicial authorities shall have the authority to order that those measures shall be carried out at the expense of the infringer, unless particular reasons are invoked for not doing so. Article 263 Injunctions Each Party shall ensure that, where a judicial decision is taken finding an infringement of an intellectual property right, the judicial authorities may issue against the infringer an injunction aimed at prohibiting the continuation of the infringement. Each Party shall also ensure that the judicial authorities may issue an injunction against intermediaries whose services are used by a third party to infringe an intellectual property right. Article 264 Alternative measures Each Party may provide that the judicial authorities, in appropriate cases and at the request of the person liable to be subject to the measures provided for in Article 262 or 263, may order pecuniary compensation to be paid to the injured party instead of applying the measures provided for in these two Articles if that person acted unintentionally and without negligence, if execution of the measures in question would cause the person disproportionate harm and if pecuniary compensation to the injured party appears reasonably satisfactory. Article 265 Damages 1. Each Party shall ensure that its judicial authorities, on application of the injured party, order the infringer who knowingly engaged, or had reasonable grounds to know it was engaging, in an infringing activity, to pay to the right holder damages appropriate to the actual prejudice suffered by the right holder as a result of the infringement. 2. Each Party shall ensure that when its judicial authorities set the damages: (a) they take into account all appropriate aspects, such as the negative economic consequences, including lost profits, which the injured party has suffered, any unfair profits made by the infringer and, in appropriate cases, elements other than economic factors, such as the moral prejudice caused to the right holder by the infringement; or (b) as an alternative to point (a), they may, in appropriate cases, set the damages as a lump sum on the basis of elements such as at least the amount of royalties or fees which would have been due if the infringer had requested authorisation to use the intellectual property right in question. 3. Where the infringer did not knowingly, or with reasonable grounds to know, engage in infringing activity, each Party may lay down that the judicial authorities may order the recovery of profits or the payment of damages which may be pre-established. Article 266 Legal costs Each Party shall ensure that reasonable and proportionate legal costs and other expenses incurred by the successful party shall, as a general rule, be borne by the unsuccessful party, unless equity does not allow this. Article 267 Publication of judicial decisions Each Party shall ensure that, in legal proceedings instituted for infringement of an intellectual property right, the judicial authorities may order, at the request of the applicant and at the expense of the infringer, appropriate measures for the dissemination of the information concerning the decision, including displaying the decision and publishing it in full or in part. Article 268 Presumption of authorship or ownership For the purposes of applying the measures, procedures and remedies provided for in Chapter 3: (a) for the author of a literary or artistic work, in the absence of proof to the contrary, to be regarded as such, and consequently to be entitled to institute infringement proceedings, it shall be sufficient for the author's name to appear on the work in the usual manner; and (b) point (a) applies mutatis mutandis to the holders of rights related to copyright with regard to their protected subject matter. Article 269 Administrative procedures To the extent that any civil remedy can be ordered on the merits of a case as a result of administrative procedures, such procedures shall conform to principles equivalent in substance to those set forth in this Section. SECTION 3 CIVIL JUDICIAL PROCEDURES AND REMEDIES OF TRADE SECRETS Article 270 Civil judicial procedures and remedies of trade secrets 1. Each Party shall ensure that any person participating in the civil judicial proceedings referred to in Article 252(1), or who has access to documents which form part of those proceedings, is not permitted to use or disclose any trade secret or alleged trade secret which the competent judicial authorities have, in response to a duly reasoned application by an interested party, identified as confidential and of which they have become aware as a result of such participation or access. 2. Each Party shall ensure that the obligation referred to in paragraph 1 remains in force after the civil judicial proceedings have ended, for as long as appropriate. 3. In the civil judicial proceedings referred to Article 252(1), each Party shall provide that its judicial authorities have the authority at least to: (a) order provisional measures, in accordance with their respective laws and regulations, to cease and prohibit the use or disclosure of the trade secret in a manner contrary to honest commercial practices; (b) order measures, in accordance with their respective laws and regulations, ordering the cessation of, or as the case may be, the prohibition of the use or disclosure of the trade secret in a manner contrary to honest commercial practices; (c) order, in accordance with their respective laws and regulations, any person who has acquired, used or disclosed a trade secret in a manner contrary to honest commercial practices and that knew or ought to have known that he or she or it was acquiring, using or disclosing a trade secret in a manner contrary to honest commercial practices to pay the trade secret holder damages appropriate to the actual prejudice suffered as a result of such acquisition, use or disclosure of the trade secret; (d) take specific measures necessary to preserve the confidentiality of any trade secret or alleged trade secret used or referred to in proceedings as referred to in Article 252(1). Such specific measures may include, in accordance with each Party's respective laws and regulations, including the rights of defence, the possibility of restricting access to certain documents in whole or in part; of restricting access to hearings and their corresponding records or transcript; and of making available a non-confidential version of judicial decision in which the passages containing trade secrets have been removed or redacted. (e) impose sanctions on any person participating in the legal proceedings who fail or refuse to comply with the court orders concerning the protection of the trade secret or alleged trade secret. 4. Each Party shall ensure that an application for the measure, procedures or remedies provided for in this Article is dismissed where the alleged acquisition, use or disclosure of a trade secret contrary to honest commercial practices was carried out, in accordance with its laws and regulations: (a) to reveal misconduct, wrongdoing or illegal activity for the purpose of protecting the general public interest; (b) as a disclosure by employees to their representatives as part of, and necessary for, the legitimate exercise by those representatives of their functions; (c) to protect a legitimate interest recognised by the laws and regulations of that Party. SECTION 4 BORDER ENFORCEMENT Article 271 Border measures 1. With respect to goods under customs control, each Party shall adopt or maintain procedures under which a right holder may submit applications to a competent authority (40) to suspend the release of or detain suspected goods. For the purposes of this Section, "suspected goods" means goods suspected of infringing trade marks, copyrights and related rights, geographical indications, patents, utility models, industrial designs, topographies of integrated circuits and plant variety rights. 2. Each Party shall have in place electronic systems for the management by customs of the applications granted or recorded. 3. Each Party shall ensure that its competent authorities do not charge a fee to cover the administrative costs resulting from the processing of an application or a recordation. 4. Each Party shall ensure that its competent authorities decide about granting or recording applications within a reasonable period of time. 5. Each Party shall provide for the applications referred to in paragraph 1 to apply to multiple shipments. 6. With respect to goods under customs control, each Party shall ensure that its customs authorities may act upon their own initiative to suspend the release of or detain suspected goods. 7. Each Party shall ensure that its customs authorities use risk analysis to identify suspected goods. 8. Each Party may authorise its customs authority to provide a right holder, upon request, with information about goods, including a description and the actual or estimated quantities thereof, and if known, the name and address of the consignor, importer, exporter or consignee, and the country of origin or provenance of the goods, whose release has been suspended, or which have been detained. 9. Each Party shall have in place procedures allowing for the destruction of suspected goods, without there being any need for prior administrative or judicial proceedings for the formal determination of the infringements, where the persons concerned agree or do not oppose the destruction. In case suspected goods are not destroyed, each Party shall ensure that, except in exceptional circumstances, such goods are disposed of outside the commercial channel in a manner which avoids any harm to the right holder. 10. Each Party shall have in place procedures allowing for the swift destruction of counterfeit trade mark and pirated goods sent in postal or express couriers' consignments. 11. Each Party shall provide that, where requested by the customs authorities, the holder of the granted or recorded application shall be obliged to reimburse the costs incurred by the customs authorities, or other parties acting on behalf of customs authorities, from the moment of detention or suspension of the release of the goods, including storage, handling, and any costs relating to the destruction or disposal of the goods. 12. Each Party may decide not to apply this Article to the import of goods put on the market in another country by or with the consent of the right holders. A Party may exclude from the application of this Article goods of a non-commercial nature contained in travellers' personal luggage. 13. Each Party shall allow its customs authorities to maintain a regular dialogue and promote cooperation with the relevant stakeholders and with other authorities involved in the enforcement of intellectual property rights. 14. The Parties shall cooperate in respect of international trade in suspected goods. In particular, the Parties shall, as far as possible, share relevant information on trade in suspected goods affecting the other Party. 15. Without prejudice to other forms of cooperation, the Protocol on mutual administrative assistance in customs matters applies with regard to breaches of legislation on intellectual property rights for the enforcement of which the customs authorities of a Party are competent in accordance with this Article. Article 272 Consistency with GATT 1994 and the TRIPS Agreement In implementing border measures for the enforcement of intellectual property rights by customs, whether or not covered by this Section, the Parties shall ensure consistency with their obligations under GATT 1994 and the TRIPS Agreement and, in particular, with Article V of GATT 1994 and Article 41 and Section 4 of Part III of the TRIPS Agreement. CHAPTER 4 OTHER PROVISIONS Article 273 Cooperation 1. The Parties shall cooperate with a view to supporting the implementation of the commitments and obligations undertaken under this Title. 2. The areas of cooperation include, but are not limited to, the following activities: (a) exchange of information on the legal framework concerning intellectual property rights and relevant rules of protection and enforcement; (b) exchange of experience on legislative progress, on the enforcement of intellectual property rights and on enforcement at central and sub-central level by customs, police, administrative and judiciary bodies; (c) coordination to prevent exports of counterfeit goods, including coordination with other countries; (d) technical assistance, capacity building, exchange and training of personnel; (e) protection and defence of intellectual property rights and the dissemination of information in this regard in, among others, to business circles and civil society; (f) public awareness of consumers and right holders; (g) the enhancement of institutional cooperation, particularly between the intellectual property offices of the Parties; (h) educating and promoting awareness among the general public regarding policies concerning the protection and enforcement of intellectual property rights; (i) the promotion of protection and enforcement of intellectual property rights with public-private collaboration involving small and medium-size enterprises; (j) the formulation of effective strategies to identify audiences and communication programmes to increase consumer and media awareness of the impact of intellectual property rights' violations, including the risk to health and safety and the connection to organised crime. 3. The Parties shall, either directly or through the Trade Specialised Committee on Intellectual Property, maintain contact on all matters related to the implementation and functioning of this Title. Article 274 Voluntary stakeholder initiatives Each Party shall endeavour to facilitate voluntary stakeholder initiatives to reduce intellectual property rights infringement, including online and in other marketplaces focusing on concrete problems and seeking practical solutions that are realistic, balanced, proportionate and fair for all concerned including in the following ways: (a) each Party shall endeavour to convene stakeholders consensually in its territory to facilitate voluntary initiatives to find solutions and resolve differences regarding the protection and enforcement of intellectual property rights and reducing infringement; (b) the Parties shall endeavour to exchange information with each other regarding efforts to facilitate voluntary stakeholder initiatives in their respective territories; and (c) the Parties shall endeavour to promote open dialogue and cooperation among the Parties' stakeholders, and to encourage the Parties' stakeholders to jointly find solutions and resolve differences regarding the protection and enforcement of intellectual property rights and reducing infringement. Article 275 Review in relation to geographical indications Noting the relevant provisions of any earlier bilateral agreement between the United Kingdom of the one part and the European Union and European Atomic Energy Community of the other part, the Parties may jointly use reasonable endeavours to agree rules for the protection and effective domestic enforcement of their geographical indications. TITLE VI PUBLIC PROCUREMENT CHAPTER 1 SCOPE Article 276 Objective The objective of this Title is to guarantee each Party's suppliers access to increased opportunities to participate in public procurement procedures and to enhance the transparency of public procurement procedures. Article 277 Incorporation of certain provisions of the GPA and covered procurement 1. The provisions of the GPA that are specified in Section A of Annex 25, including the Annexes of each Party to Appendix I to the GPA, are hereby incorporated into this Title. 2. For the purposes of this Title, "covered procurement" means procurement to which Article II of the GPA applies and, in addition, procurement listed in Section B of Annex 25. 3. With regard to covered procurement, each Party shall apply, mutatis mutandis, the provisions of the GPA specified in Section A of Annex 25 to suppliers, goods or services of the other Party. CHAPTER 2 ADDITIONAL RULES FOR COVERED PROCUREMENT Article 278 Use of electronic means in procurement 1. Each Party shall ensure that its procuring entities conduct covered procurement by electronic means to the widest extent practicable. 2. A procuring entity is considered as conducting covered procurement by electronic means, if the entity uses electronic means of information and communication for: (a) the publication of notices and tender documentation in procurement procedures; and (b) the submission of requests to participate and of tenders. 3. Except for specific situations, such electronic means of information and communication shall be non-discriminatory, generally available and interoperable with the information and communication technology products in general use and shall not restrict access to the procurement procedure. 4. Each Party shall ensure that its procuring entities receive and process electronic invoices in accordance with its legislation. Article 279 Electronic publication With regard to covered procurement, all procurement notices including notices of intended procurement, summary notices, notices of planned procurement and contract award notices shall be directly accessible by electronic means, free of charge, through a single point of access on the internet. Article 280 Supporting evidence Each Party shall ensure that at the time of submission of requests to participate or at the time of submission of tenders, procuring entities do not require suppliers to submit all or part of the supporting evidence that they are not in one of the situations in which a supplier may be excluded and that they fulfil the conditions for participation unless this is necessary to ensure the proper conduct of the procurement. Article 281 Conditions for participation Each Party shall ensure that where its procuring entities require a supplier, as a condition for participation in a covered procurement, to demonstrate prior experience they do not require that the supplier has such experience in the territory of that Party. Article 282 Registration systems and qualification procedures A Party that maintains a supplier registration system shall ensure that interested suppliers may request registration at any time. Any interested supplier having made a request shall be informed within a reasonable period of time of the decision to grant or reject this request. Article 283 Selective tendering Each Party shall ensure that where a procuring entity uses a selective tendering procedure, the procuring entity addresses invitations to submit a tender to a number of suppliers that is sufficient to ensure genuine competition without affecting the operational efficiency of the procurement system. Article 284 Abnormally low prices Further to paragraph 6 of Article XV of the GPA, if a procuring entity receives a tender with a price that is abnormally lower than the prices in other tenders submitted, it may also verify with the supplier whether the price takes into account the grant of subsidies. Article 285 Environmental, social and labour considerations Each Party shall ensure that its procuring entities may take into account environmental, labour and social considerations throughout the procurement procedure, provided that those considerations are compatible with the rules established by Chapters 1 and 2 and are indicated in the notice of intended procurement or in another notice used as a notice of intended procurement or tender documentation. Article 286 Domestic review procedures 1. Where an impartial administrative authority is designated by a Party under paragraph 4 of Article XVIII of the GPA, that Party shall ensure that: (a) the members of the designated authority are independent, impartial, and free from external influence during the term of appointment; (b) the members of the designated authority are not dismissed against their will while they are in office, unless their dismissal is required by the provisions governing the designated authority; and (c) the President or at least one other member of the designated authority, has legal and professional qualifications equivalent to those necessary for judges, lawyers or other legal experts qualified under the laws and regulations of the Party. 2. Each Party shall adopt or maintain procedures that provide for rapid interim measures to preserve the supplier's opportunity to participate in the procurement. Such interim measures, provided for in subparagraph 7(a) of Article XVIII of the GPA, may result in suspension of the procurement process or, if a contract has been concluded by the procuring entity and if a Party has so provided, in suspension of performance of the contract. The procedures may provide that overriding adverse consequences for the interests concerned, including the public interest, may be taken into account when deciding whether such measures should be applied. Just cause for not acting shall be provided in writing. 3. In case an interested or participating supplier has submitted a challenge with the designated authority referred to in paragraph 1, each Party shall, in principle, ensure that a procuring entity shall not conclude the contract until that authority has made a decision or recommendation on the challenge with regard to interim measures, corrective action or compensation for the loss or damages suffered as referred to in paragraphs 2, 5 and 6 in accordance with its rules, regulations and procedures. Each Party may provide that in unavoidable and duly justified circumstances, the contract can be nevertheless concluded. 4. Each Party may provide for: (a) a standstill period between the contract award decision and the conclusion of a contract in order to give sufficient time to unsuccessful suppliers to assess whether it is appropriate to initiate a review procedure; or (b) a sufficient period for an interested supplier to submit a challenge, which may constitute grounds for the suspension of the execution of a contract. 5. Corrective action under subparagraph 7(b) of Article XVIII of the GPA may include one or more of the following: (a) the removal of discriminatory technical, economic or financial specifications in the invitation to tender, the contract documents or any other document relating to the tendering procedure and conduct of new procurement procedures; (b) the repetition of the procurement procedure without changing the conditions; (c) the setting aside of the contract award decision and the adoption of a new contract award decision; (d) the termination of a contract or the declaration of its ineffectiveness; or (e) the adoption of other measures with the aim to remedy a breach of Chapters 1 and 2, for example an order to pay a particular sum until the breach has been effectively remedied. 6. In accordance with subparagraph 7(b) of Article XVIII of the GPA, each Party may provide for the award of compensation for the loss or damages suffered. In this regard, if the review body of the Party is not a court and a supplier believes that there has been a breach of the domestic laws and regulations implementing the obligations under Chapters 1 and 2 of this Title, the supplier may bring the matter before a court, including with a view to seeking compensation, in accordance with judicial procedures of the Party. 7. Each Party shall adopt or maintain the necessary procedures by which the decisions or recommendations made by review bodies are effectively implemented, or the decisions by judicial review bodies are effectively enforced. CHAPTER 3 NATIONAL TREATMENT BEYOND COVERED PROCUREMENT Article 287 Definitions 1. For the purposes of this Chapter, the treatment accorded by a Party under this Chapter means: (a) with respect to the United Kingdom, treatment no less favourable than the most favourable treatment accorded, in like situations, to suppliers of the United Kingdom; and (b) with respect to a Member State, treatment no less favourable than the most favourable treatment accorded, in like situations, within that Member State to suppliers of that Member State. 2. For the purposes of this Chapter, a supplier of a Party, which is a legal person means: (a) for the Union, a legal person constituted or organised under the law of the Union or at least one of its Member States and engaged in substantive business operations, understood by the Union, in line with its notification of the Treaty establishing the European Community to the WTO (WT/REG39/1), as equivalent to the concept of "effective and continuous link" with the economy of a Member State enshrined in Article 54 of the TFEU, in the territory of the Union; and (b) for the United Kingdom, a legal person constituted or organised under the law of the United Kingdom and engaged in substantive business operations in the territory of the United Kingdom. Article 288 National treatment of locally established suppliers 1. With regard to any procurement, a measure of a Party shall not result for suppliers of the other Party established in its territory through the constitution, acquisition or maintenance of a legal person in treatment less favourable than that Party accords to its own like suppliers (41). 2. The application of the national treatment obligation provided for in this Article remains subject to security and general exceptions as defined in Article III of the GPA, even if the procurement is not covered procurement in accordance with this Title. CHAPTER 4 OTHER PROVISIONS Article 289 Modifications and rectifications of market access commitments Each Party may modify or rectify its market access commitments in its respective Sub-section under Section B of Annex 25 in accordance with the procedures set out in Articles 290 to 293. Article 290 Modifications 1. A Party intending to modify a Sub-section of Section B of Annex 25, shall: (a) notify the other Party in writing; and (b) include in the notification a proposal for appropriate compensatory adjustments to the other Party to maintain a level of market access commitments comparable to that existing prior to the modification. 2. Notwithstanding point (b) of paragraph 1, a Party is not required to provide compensatory adjustments to the other Party if the proposed modification covers a procuring entity over which the Party has effectively eliminated its control or influence in respect of covered procurement. A Party's control or influence over the covered procurement of procuring entities is presumed to be effectively eliminated if the procuring entity is exposed to competition in markets to which access is not restricted. 3. The other Party may object to the modification referred to in point (a) of paragraph 1 if it disputes that: (a) a compensatory adjustment proposed under point (b) of paragraph 1 is adequate to maintain a comparable level of mutually agreed market access commitments; or (b) the modification covers a procuring entity over which the Party has effectively eliminated its control or influence as provided for in paragraph 2. The other Party shall object in writing within 45 days of receipt of the notification referred to in point (a) of paragraph 1 or be deemed to have accepted the compensatory adjustment or modification, including for the purposes of Title I of Part Six. Article 291 Rectifications 1. A Party intending to rectify a Sub-section under Section B of Annex 25 shall notify the other Party in writing. The following changes to a Sub-section under Section B of Annex 25 shall be considered a rectification, provided that they do not affect the mutually agreed market access commitments provided for in this Title: (a) a change in the name of a procuring entity; (b) a merger of two or more procuring entities listed within that Sub-section; and (c) the separation of a procuring entity listed in that Sub-section into two or more procuring entities that are added to the procuring entities listed in the same Sub-section. 2. A Party may notify the other Party of an objection to a proposed rectification within 45 days from having received the notification. A Party submitting an objection shall set out the reasons for considering the proposed rectification not as a change provided for in paragraph 1, and describe the effect of the proposed rectification on the mutually agreed market access commitments provided for in this Title. If no such objection is submitted in writing within 45 days after having received the notification, the Party shall be deemed to have agreed to the proposed rectification. Article 292 Consultations and dispute resolution If a Party objects to the proposed modification or the proposed compensatory adjustments referred to in Article 290 or to the proposed rectification referred to in Article 291, the Parties shall seek to resolve the issue through consultations. If no agreement is found within 60 days of receipt of the objection, the Party seeking to modify or rectify its Sub-section under Section B of Annex 25 may refer the matter to dispute settlement in accordance with Title I of Part Six, to determine whether the objection is justified. Article 293 Amendment of Section B of Annex 25 If a Party does not object to the modification pursuant to Article 290(3) or to a rectification pursuant to Article 291(2), or the modifications or rectifications are agreed between the Parties through the consultations referred to in Article 292, or there is a final settlement of the matter under Title I of Part Six, the Partnership Council shall amend the relevant Sub-section under Section B of Annex 25 to reflect the corresponding modifications or rectifications or the compensatory adjustments. Article 294 Cooperation 1. The Parties recognise the benefits that may arise from cooperating in the international promotion of the mutual liberalisation of public procurement markets. 2. The Parties shall make available to each other annual statistics on covered procurement subject to technical availability. TITLE VII SMALL AND MEDIUM-SIZED ENTERPRISES Article 295 Objective The objective of this Title is to enhance the ability of small and medium-sized enterprises to benefit from this Heading. Article 296 Information sharing 1. Each Party shall establish or maintain its own publicly accessible website for small and medium-sized enterprises with information regarding this Heading, including: (a) a summary of this Heading; (b) a description of the provisions in this Heading that each Party considers to be relevant to small and medium-sized enterprises of both Parties; and (c) any additional information that each Party considers would be useful for small and medium-sized enterprises interested in benefitting from this Heading. 2. Each Party shall include an internet link in the website provided for in paragraph 1 to the: (a) text of this Heading; (b) equivalent website of the other Party; and (c) websites of its own authorities that the Party considers would provide useful information to persons interested in trading and doing business in its territory. 3. Each Party shall include an internet link in the website referred to in paragraph 1 to websites of its own authorities with information related to the following: (a) customs laws and regulations, procedures for importation, exportation and transit as well as relevant forms, documents and other information required; (b) laws, regulations and procedures concerning intellectual property rights, including geographical indications; (c) technical laws and regulations including, where necessary, obligatory conformity assessment procedures and links to lists of conformity assessment bodies, in cases where third party conformity assessment is obligatory, as provided for in Chapter 4 of Title I; (d) laws and regulations on sanitary and phytosanitary measures relating to importation and exportation as provided for in Chapter 3 of Title I; (e) laws and regulations on public procurement, single point of access on the internet to public procurement notices as provided for in Title VI and other relevant provisions contained in that Title; (f) company registration procedures; and (g) other information which the Party considers may be of assistance to small and medium-sized enterprises. 4. Each Party shall include an internet link in the website provided for in paragraph 1 to a database that is electronically searchable by tariff nomenclature code and that includes the following information with respect to access to its market: (a) in respect of tariff measures and tariff-related information: (i) rates of customs duties and quotas, including most-favoured nation, rates concerning non most-favoured nation countries and preferential rates and tariff rate quotas; (ii) excise duties; (iii) taxes (value added tax/ sales tax); (iv) customs or other fees, including other product specific fees; (v) rules of origin as provided for in Chapter 2 of Title I; (vi) duty drawback, deferral, or other types of relief that reduce, refund, or waive customs duties; (vii) criteria used to determine the customs value of the good; and (viii) other tariff measures; (b) in respect of tariff nomenclature related non-tariff measures: (i) information needed for import procedures; and (ii) information related to non-tariff measures. 5. Each Party shall regularly, or if requested by the other Party, update the information and links referred to in paragraphs 1 to 4 that it maintains on its website to ensure such information and links are up-to-date and accurate. 6. Each Party shall ensure that the information and links referred to in paragraphs 1 to 4 is presented in an adequate manner to use for small and medium-sized enterprises. Each Party shall endeavour to make the information available in English. 7. No fee shall apply for access to the information provided pursuant to paragraphs 1 to 4 for any person of either Party. Article 297 Small and medium-sized enterprises contact points 1. Upon the entry into force of this Agreement, each Party shall designate a contact point to carry out the functions listed in this Article and notify the other Party of its contact details. The Parties shall promptly notify each other of any change of those contact details. 2. The small and medium-sized enterprises contact points of the Parties shall: (a) seek to ensure that the needs of small and medium-sized enterprises are taken into account in the implementation of this Heading and that small and medium-sized enterprises of both Parties can take advantage of this Heading; (b) consider ways for strengthening the cooperation on matters of relevance to small and medium-sized enterprises between the Parties in view of increasing trade and investment opportunities for small and medium-sized enterprises; (c) ensure that the information referred to in Article 296 is up-to-date, accurate and relevant for small and medium-sized enterprises. Either Party may, through the small and medium-sized enterprises contact point, suggest additional information that the other Party may include in its websites to be maintained in accordance with Article 296; (d) examine any matter relevant to small and medium-sized enterprises in connection with the implementation of this Heading, including: (i) exchanging information to assist the Partnership Council in its task to monitor and implement the small and medium-sized enterprises-related aspects of this Heading; (ii) assisting specialised committees, joint working groups and contact points established by this Agreement in considering matters of relevance to small and medium-sized enterprises; (e) report periodically on their activities, jointly or individually, to the Partnership Council for its consideration; and (f) consider any other matter arising under this Agreement pertaining to small and medium-sized enterprises as the Parties may agree. 3. The small and medium-sized enterprises contact points of the Parties shall carry out their work through the communication channels decided by the Parties, which may include electronic mail, videoconferencing or other means. They may also meet, as appropriate. 4. Small and medium-sized enterprises contact points may seek to cooperate with experts and external organisations, as appropriate, in carrying out their activities. Article 298 Relation with Part Six Title I of Part Six does not apply to this Title. TITLE VIII ENERGY CHAPTER 1 GENERAL PROVISIONS Article 299 Objectives The objectives of this Title are to facilitate trade and investment between the Parties in the areas of energy and raw materials, and to support security of supply and environmental sustainability, notably in contributing to the fight against climate change in those areas. Article 300 Definitions 1. For the purposes of this Title, the following definitions apply: (a) "Agency for the Cooperation of Energy Regulators" means the Agency established by Regulation (EU) 2019/942 of the European Parliament and of the Council (42); (b) "authorisation" means the permission, licence, concession or similar administrative or contractual instrument by which the competent authority of a Party entitles an entity to exercise a certain economic activity in its territory; (c) "balancing" means: (i) for electricity systems, all actions and processes, in all timelines, through which electricity transmission system operators ensure, in an ongoing manner, maintenance of the system frequency within a predefined stability range and compliance with the amount of reserves needed with respect to the required quality; (ii) for gas systems, actions undertaken by gas transmission system operators to change the gas flows onto or off the transmission network, excluding those actions related to gas unaccounted for as off-taken from the system and gas used by the transmission system operator for the operation of the system; (d) "distribution" means: (i) in relation to electricity, the transport of electricity on high-voltage, medium-voltage and low-voltage distribution systems with a view to its delivery to customers, but does not include supply; (ii) in relation to gas, the transport of natural gas through local or regional pipeline networks with a view to its delivery to customers, but does not include supply; (e) "distribution system operator" means a natural or legal person who is responsible for operating, ensuring the maintenance of, and, if necessary, developing the electricity or gas distribution system in a given area and, where applicable, its interconnections with other systems, and for ensuring the long-term ability of the system to meet reasonable demands for the distribution of electricity or gas; (f) "electricity interconnector" means a transmission line: (i) between the Parties, excluding any such line wholly within the single electricity market in Ireland and Northern Ireland; (ii) between Great Britain and the single electricity market in Ireland and Northern Ireland that is outside the scope of point (i); (g) "energy goods" means the goods from which energy is generated, listed by the corresponding Harmonised System (HS) code in Annex 26; (h) "entity" means any natural person, legal person or enterprise or group thereof; (i) "gas interconnector" means a transmission line which crosses or spans the border between the Parties; (j) "generation" means the production of electricity; (k) "hydrocarbons" means the goods listed by the corresponding HS code in Annex 26; (l) "interconnection point" means, in relation to gas, a physical or virtual point connecting Union and United Kingdom entry-exit systems or connecting an entry-exit system with an interconnector, in so far as these points are subject to booking procedures by network users; (m) "raw materials" means the goods listed by the corresponding HS chapter in Annex 26; (n) "renewable energy" means a type of energy, including electrical energy, produced from renewable non-fossil sources; (o) "standard capacity product" means, in relation to gas, a certain amount of transport capacity over a given period of time, at a specific interconnection point; (p) "transmission" means: (i) in relation to electricity, the transport of electricity on the extra high-voltage and high-voltage system with a view to its delivery to customers or to distributors, but does not include supply; (ii) in relation to gas, the transport of natural gas through a network, which mainly contains high-pressure pipelines, other than an upstream pipeline network and other than the part of high-pressure pipelines primarily used in the context of local distribution of natural gas, with a view to its delivery to customers, but not including supply; (q) "transmission system operator" means a natural or legal person who carries out the function of transmission or is responsible for operating, ensuring the maintenance of, and, if necessary, developing the electricity or gas transmission system in a given area and, where applicable, its interconnections with other systems, and for ensuring the long-term ability of the system to meet reasonable demands for the transport of gas or electricity, as the case may be; (r) "upstream pipeline network" means any pipeline or network of pipelines operated or constructed as part of an oil or gas production project, or used to convey natural gas from one or more such projects to a processing plant or terminal or final coastal landing terminal. 2. For the purposes of this Title, references to "non-discriminatory" and "non-discrimination" mean most-favoured-nation treatment as defined in Articles 130 and 138 and national treatment as defined in Articles 129 and 137, as well as treatment under terms and conditions no less favourable than that accorded to any other like entity in like situations. Article 301 Relationship with other Titles 1. Chapter 2 and Chapter 3 of Title II of this Heading apply to energy and raw materials. In the event of any inconsistency between this Title and Title II of this Heading and Annexes 19 to 24, Title II of this Heading and Annexes 19 to 24 shall prevail. 2. For the purposes of Article 20 where a Party maintains or implements a system of virtual trading of natural gas or electricity using pipelines or electricity grids, meaning a system which does not require physical identification of the transited natural gas or electricity but is based on a system of netting inputs and outputs, the routes most convenient for international transit as referred to in that Article shall be deemed to include such virtual trading. 3. When applying Chapter 3 of Title XI of this Heading, Annex 27 also applies. Chapter 3 of Title XI of this Heading applies to Annex 27. Article 375 applies to disputes arising between the Parties concerning the interpretation and application of Annex 27. Article 302 Principles Each Party preserves the right to adopt, maintain and enforce measures necessary to pursue legitimate public policy objectives, such as securing the supply of energy goods and raw materials, protecting society, the environment, including fighting against climate change, public health and consumers and promoting security and safety, consistent with the provisions of this Agreement. CHAPTER 2 ELECTRICITY AND GAS SECTION 1 COMPETITION IN ELECTRICITY AND GAS MARKETS Article 303 Competition in markets and non-discrimination 1. With the objective of ensuring fair competition, each Party shall ensure that its regulatory framework for the production, generation, transmission, distribution or supply of electricity or natural gas is non-discriminatory with regard to rules, fees and treatment. 2. Each Party shall ensure that customers are free to choose, or switch to, the electricity or natural gas supplier of their choice within their respective retail markets in accordance with the applicable laws and regulations. 3. Without prejudice to the right of each Party to define quality requirements, the provisions in this Chapter related to natural gas also apply to biogas and gas from biomass or other types of gas in so far as such gas can technically and safely be injected into, and transported through, the natural gas system. 4. This Article does not apply to cross-border trade and is without prejudice to each Party's right to regulate in order to achieve legitimate public policy goals based on objective and non-discriminatory criteria. Article 304 Provisions relating to wholesale electricity and gas markets 1. Each Party shall ensure that wholesale electricity and natural gas prices reflect actual supply and demand. To that end, each Party shall ensure that wholesale electricity and natural gas market rules: (a) encourage free price formation; (b) do not set any technical limits on pricing that restrict trade; (c) enable the efficient dispatch of electricity generation assets, energy storage and demand response and the efficient use of the electricity system; (d) enable the efficient use of the natural gas system; and (e) enable the integration of electricity from renewable energy sources, and ensure the efficient and secure operation and development of the electricity system. 2. Each Party shall ensure that balancing markets are organised in such a way as to ensure: (a) non-discrimination between participants and non-discriminatory access to participants; (b) that services are defined in a transparent manner; (c) that services are procured in a transparent, market-based manner, taking account of the advent of new technologies; and (d) that producers of renewable energy are accorded reasonable and non-discriminatory terms when procuring products and services. A Party may decide not to apply point (c) if there is a lack of competition in the market for balancing services. 3. Each Party shall ensure that any capacity mechanism in electricity markets is clearly defined, transparent, proportionate and non-discriminatory. Neither Party is required to permit capacity situated in the territory of the other Party to participate in any capacity mechanism in its electricity markets. 4. Each Party shall assess the necessary actions to facilitate the integration of gas from renewable sources. 5. This Article is without prejudice to each Party's right to regulate in order to achieve legitimate public policy goals based on objective and non-discriminatory criteria. Article 305 Prohibition of market abuse on wholesale electricity and gas markets 1. Each Party shall prohibit market manipulation and insider trading on wholesale electricity and natural gas markets, including over-the-counter markets, electricity and natural gas exchanges and markets for the trading of electricity and natural gas, capacity, balancing and ancillary services in all timeframes, including forward, day-ahead and intraday markets. 2. Each Party shall monitor trading activity on these markets with a view to detecting and preventing trading based on inside information and market manipulation. 3. The Parties shall cooperate, including in accordance with Article 318, with a view to detecting and preventing trading based on inside information and market manipulation and, where appropriate, may exchange information including on market monitoring and enforcement activities. Article 306 Third-party access to transmission and distribution networks 1. Each Party shall ensure the implementation of a system of third-party access to their transmission and distribution networks based on published tariffs that are applied objectively and in a non-discriminatory manner. 2. Without prejudice to Article 302, each Party shall ensure that transmission and distribution system operators in its territory grant access to their transmission or distribution systems to entities in that Party's market within a reasonable period of time from the date of the request for access. Each Party shall ensure that transmission system operators treat producers of renewable energy on reasonable and non-discriminatory terms regarding connection to, and use of, the electricity network. The transmission or distribution system operator may refuse access where it lacks the necessary capacity. Duly substantiated reasons shall be given for any such refusal. 3. Without prejudice to legitimate public policy objectives, each Party shall ensure that charges applied to entities in that Party's market by transmission and distribution system operators for access to, connection to or the use of networks, and, where applicable, charges for related network reinforcements, are appropriately cost-reflective and transparent. Each Party shall ensure publication of the terms, conditions, tariffs and all such information that may be necessary for the effective exercise of the right of access to and use of transmission and distribution systems. 4. Each Party shall ensure that the tariffs and charges referred to in paragraphs 1 and 3 are applied in a non-discriminatory manner with respect to entities in that Party's market. Article 307 System operation and unbundling of transmission network operators 1. Each Party shall ensure that transmission system operators carry out their functions in a transparent, non-discriminatory way. 2. Each Party shall implement arrangements for transmission system operators which are effective in removing any conflicts of interest arising as a result of the same person exercising control over a transmission system operator and a producer or supplier. Article 308 Public policy objectives for third-party access and ownership unbundling 1. Where necessary to fulfil a legitimate public policy objective and based on objective criteria, a Party may decide not to apply Articles 306 and 307 to the following: (a) emergent or isolated markets or systems; (b) infrastructure which meets the conditions set out in Annex 28. 2. Where necessary to fulfil a legitimate public policy objective and based on objective criteria, a Party may decide not to apply Articles 303 and 304 to: (a) small or isolated electricity markets or systems; (b) small, emergent or isolated natural gas markets or systems. Article 309 Existing exemptions for interconnectors Each Party shall ensure that exemptions granted to interconnections between the Union and the United Kingdom under Article 63 of Regulation (EU) 2019/943 of the European Parliament and of the Council (43) and under the law transposing Article 36 of Directive 2009/73/EC of the European Parliament and of the Council (44) in their respective jurisdictions, the terms of which extend beyond the transition period, continue to apply in accordance with the laws of their respective jurisdictions and the terms applicable. Article 310 Independent regulatory authority 1. Each Party shall ensure the designation and maintenance of an operationally independent regulatory authority or authorities for electricity and gas with the following powers and duties: (a) fixing or approving the tariffs, charges and conditions for access to networks referred to in Article 306, or the methodologies underlying them; (b) ensuring compliance with the arrangements referred to in Articles 307 and 308; (c) issuing binding decisions at least in relation to points (a) and (b); (d) imposing effective remedies. 2. In performing those duties and exercising those powers, the independent regulatory authority or authorities shall act impartially and transparently. SECTION 2 TRADING OVER INTERCONNECTORS Article 311 Efficient use of electricity interconnectors 1. With the aim of ensuring the efficient use of electricity interconnectors and reducing barriers to trade between the Union and the United Kingdom, each Party shall ensure that: (a) capacity allocation and congestion management on electricity interconnectors is market based, transparent and non-discriminatory; (b) the maximum level of capacity of electricity interconnectors is made available, respecting the: (i) need to ensure secure system operation; and (ii) most efficient use of systems; (c) electricity interconnector capacity may only be curtailed in emergency situations and any such curtailment takes place in a non-discriminatory manner; (d) information on capacity calculation is published to support the objectives of this Article; (e) there are no network charges on individual transactions on, and no reserve prices for the use of, electricity interconnectors; (f) capacity allocation and congestion management across electricity interconnectors is coordinated between concerned Union transmission system operators and United Kingdom transmission system operators; this coordination shall involve the development of arrangements to deliver robust and efficient outcomes for all relevant timeframes, being forward, day-ahead, intraday and balancing; and (g) capacity allocation and congestion management arrangements contribute to supportive conditions for the development of, and investment in, economically efficient electricity interconnection. 2. The coordination and arrangements referred to in point (f) of paragraph 1 shall not involve or imply participation by United Kingdom transmission system operators in Union procedures for capacity allocation and congestion management. 3. Each Party shall take the necessary steps to ensure the conclusion as soon as possible of a multi-party agreement relating to the compensation for the costs of hosting cross-border flows of electricity between: (a) transmission system operators participating in the inter-transmission system operator compensation mechanism established by Commission Regulation (EU) No 838/2010 (45); and (b) United Kingdom transmission system operators. 4. The multi-party agreement referred to in paragraph 3 shall aim to ensure: (a) that United Kingdom transmission system operators are treated on an equivalent basis to a transmission system operator in a country participating in the inter-transmission system operator compensation mechanism; and (b) the treatment of United Kingdom transmission system operators is not more favourable in comparison to that which would apply to a transmission system operator participating in the inter-transmission system operator compensation mechanism. 5. Notwithstanding point (e) of paragraph 1, until such time as the multi-party agreement referred to in paragraph 3 has been concluded, a transmission system use fee may be levied on scheduled imports and exports between the Union and the United Kingdom. Article 312 Electricity trading arrangements at all timeframes 1. For capacity allocation and congestion management at the day ahead stage, the Specialised Committee on Energy, as a matter of priority, shall take the necessary steps in accordance with Article 317 to ensure that transmission system operators develop arrangements setting out technical procedures in accordance with Annex 29 within a specific timeline. 2. If the Specialised Committee on Energy does not recommend that the Parties implement such technical procedures in accordance with Article 317(4), it shall take decisions and make recommendations as necessary for electricity interconnector capacity to be allocated at the day-ahead market timeframe in accordance with Annex 29. 3. The Specialised Committee on Energy shall keep under review the arrangements for all timeframes, and for balancing and intraday timeframes in particular, and may recommend that each Party requests its transmission system operators to prepare technical procedures in accordance with Article 317 to improve arrangements for a particular timeframe. 4. The Specialised Committee on Energy shall keep under review whether the technical procedures developed in accordance with paragraph 1 continue to meet the requirements of Annex 29, and shall promptly address any issues that are identified. Article 313 Efficient use of gas interconnectors 1. With the aim of ensuring the efficient use of gas interconnectors and reducing barriers to trade between the Union and the United Kingdom, each Party shall ensure that: (a) the maximum level of capacity of gas interconnectors is made available, respecting the principle of non-discrimination and taking account of: (i) the need to ensure secure system operation; and (ii) the most efficient use of systems; (b) capacity allocation mechanisms and congestion management procedures for gas interconnectors are market-based, transparent and non-discriminatory, and that auctions are generally used for the allocation of capacity at interconnection points. 2. Each Party shall take the necessary steps to ensure that: (a) transmission system operators endeavour to offer jointly standard capacity products which consist of corresponding entry and exit capacity at both sides of an interconnection point; (b) transmission system operators coordinate procedures relating to the use of gas interconnectors between Union transmission system operators and United Kingdom transmission system operators concerned. 3. The coordination referred to in point (b) of paragraph 2 shall not involve or imply participation by United Kingdom transmission system operators in Union procedures relating to the use of gas interconnectors. SECTION 3 NETWORK DEVELOPMENT AND SECURITY OF SUPPLY Article 314 Network development 1. The Parties shall cooperate to facilitate the timely development and interoperability of energy infrastructure connecting their territories. 2. Each Party shall ensure that network development plans for electricity and gas transmission systems are drawn up, published and regularly updated. Article 315 Cooperation on security of supply 1. The Parties shall cooperate with respect to the security of supply of electricity and natural gas. 2. The Parties shall exchange information on any risks identified pursuant to Article 316 in a timely manner. 3. The Parties shall share the plans referred to in Article 316. For the Union, these plans may be at Member State or regional level. 4. The Parties shall inform each other without undue delay where there is reliable information that a disruption or other crisis relating to the supply of electricity or natural gas may occur and on measures planned or taken. 5. The Parties shall immediately inform each other in the event of an actual disruption or other crisis, in view of possible coordinated mitigation and restoration measures. 6. The Parties shall share best practices regarding short-term and seasonal adequacy assessments. 7. The Parties shall develop appropriate frameworks for cooperation with respect to the security of supply of electricity and natural gas. Article 316 Risk preparedness and emergency plans 1. Each Party shall assess risks affecting the security of supply of electricity or natural gas, including the likelihood and impact of such risks, and including cross-border risks. 2. Each Party shall establish and regularly update plans to address identified risks affecting the security of supply of electricity or natural gas. Such plans shall contain the measures needed to remove or mitigate the likelihood and impact of any risk identified under paragraph 1 and the measures needed to prepare for, and mitigate the impact of, an electricity or natural gas crisis. 3. The measures contained in the plans referred to in paragraph 2 shall: (a) be clearly defined, transparent, proportionate, non-discriminatory and verifiable; (b) not significantly distort trade between the Parties; and (c) not endanger the security of supply of electricity or natural gas of the other Party. In the event of a crisis, the Parties shall only activate non-market based measures as a last resort. SECTION 4 TECHNICAL COOPERATION Article 317 Cooperation between transmission system operators 1. Each Party shall ensure that transmission system operators develop working arrangements that are efficient and inclusive in order to support the planning and operational tasks associated with meeting the objectives of this Title, including, when recommended by the Specialised Committee on Energy, the preparation of technical procedures to implement effectively the provisions of Articles 311 to 315. The working arrangements referred to in the first subparagraph shall include frameworks for cooperation between the European Network of Transmission System Operators for Electricity established in accordance with Regulation (EU) 2019/943 ("ENTSO-E") and the European Network of Transmission System Operators for Gas established in accordance with Regulation (EC) No 715/2009 of the European Parliament and of the Council (46) ("ENTSOG"), on the one side, and the transmission system operators for electricity and gas in the United Kingdom, on the other. Those frameworks shall cover at least the following areas: (a) electricity and gas markets; (b) access to networks; (c) the security of electricity and gas supply; (d) offshore energy; (e) infrastructure planning; (f) the efficient use of electricity and gas interconnectors; and (g) gas decarbonisation and gas quality. The Specialised Committee on Energy shall agree on guidance on the working arrangements and frameworks for cooperation for dissemination to transmission system operators as soon as practicable. The frameworks for cooperation mentioned in the second subparagraph shall not involve, or confer a status comparable to, membership in ENTSO-E or ENTSOG by United Kingdom transmission system operators. 2. The Specialised Committee on Energy may recommend that each Party requests its transmission system operators to prepare the technical procedures as referred to in the first subparagraph of paragraph 1. 3. Each Party shall ensure that its respective transmission system operators request the opinions of the Agency for the Cooperation of Energy Regulators and the regulatory authority in the United Kingdom designated in accordance with Article 310 on the technical procedures, respectively, in the event of a disagreement and in any event before the finalisation of those technical procedures. The Parties' respective transmission system operators shall submit those opinions together with the draft technical procedures to the Specialised Committee on Energy. 4. The Specialised Committee on Energy shall review the draft technical procedures, and may recommend that the Parties implement such procedures in their respective domestic arrangements, taking due account of the opinions of the Agency for the Cooperation of Energy Regulators and the regulatory authority in the United Kingdom designated in accordance with Article 310. The Specialised Committee on Energy shall monitor the effective operation of such technical procedures and may recommend that they be updated. Article 318 Cooperation between regulatory authorities 1. The Parties shall ensure that the Agency for the Cooperation of Energy Regulators and the regulatory authority in the United Kingdom designated in accordance with Article 310 develop contacts and enter into administrative arrangements as soon as possible in order to facilitate meeting the objectives of this Agreement. The contacts and administrative arrangements shall cover at least the following areas: (a) electricity and gas markets; (b) access to networks; (c) the prevention of market abuse on wholesale electricity and gas markets; (d) the security of electricity and gas supply; (e) infrastructure planning; (f) offshore energy; (g) the efficient use of electricity and gas interconnectors; (h) cooperation between transmission system operators; and (i) gas decarbonisation and gas quality. The Specialised Committee on Energy shall agree on guidance on the administrative arrangements for such cooperation for dissemination to regulatory authorities as soon as practicable. 2. The administrative arrangements referred to in paragraph 1 shall not involve, or confer a status comparable to, participation in the Agency for the Cooperation of Energy Regulators by the regulatory authority in the United Kingdom designated in accordance with Article 310. CHAPTER 3 SAFE AND SUSTAINABLE ENERGY Article 319 Renewable energy and energy efficiency 1. Each Party shall promote energy efficiency and the use of energy from renewable sources. Each Party shall ensure that its rules that apply to licencing or equivalent measures applicable to energy from renewable sources are necessary and proportionate. 2. The Union reaffirms the target for the share of gross final energy consumption from renewable energy sources in 2030 as set out in Directive (EU) 2018/2001 of the European Parliament and of the Council (47). The Union reaffirms its energy efficiency targets for 2030 as set out in the Directive 2012/27/EU of the European Parliament and of the Council (48). 3. The United Kingdom reaffirms: (a) its ambition for the share of energy from renewable sources in gross final energy consumption in 2030 as set out in its National Energy and Climate Plan; (b) its ambition for the absolute level of primary and final energy consumption in 2030 as set out in its National Energy and Climate Plan. 4. The Parties shall keep each other informed in relation to the matters referred to in paragraphs 2 and 3. Article 320 Support for renewable energy 1. Each Party shall ensure that support for electricity from renewable sources facilitates the integration of electricity from renewable sources in the electricity market. 2. Biofuels, bioliquids and biomass shall only be supported as renewable energy if they meet robust criteria for sustainability and greenhouse gas emissions saving, which are subject to verification. 3. Each Party shall clearly define any technical specifications which are to be met by renewable energy equipment and systems in order to benefit from support schemes. Such technical specifications shall take into account cooperation developed under Articles 91, 92 and 323. Article 321 Cooperation in the development of offshore renewable energy 1. The Parties shall cooperate in the development of offshore renewable energy by sharing best practices and, where appropriate, by facilitating the development of specific projects. 2. Building on the North Seas Energy Cooperation, the Parties shall enable the creation of a specific forum for technical discussions between the European Commission, ministries and public authorities of the Member States, United Kingdom ministries and public authorities, transmission system operators and the offshore energy industry and stakeholders more widely, in relation to offshore grid development and the large renewable energy potential of the North Seas region. That cooperation shall include at least the following areas: (a) hybrid and joint projects; (b) maritime spatial planning; (c) support framework and finance; (d) best practices on respective onshore and offshore grid planning; (e) the sharing of information on new technologies; and (f) the exchange of best practices in relation to the relevant rules, regulations and technical standards. Article 322 Offshore risk and safety 1. The Parties shall cooperate and exchange information with the aim of maintaining high levels of safety and environmental protection for all offshore oil and gas operations. 2. The Parties shall take appropriate measures to prevent major accidents from offshore oil and gas operations and to limit the consequences of such accidents. 3. The Parties shall promote the exchange of best practices among their authorities that are competent for the safety and environmental protection of offshore oil and gas operations. The regulation of the safety and environmental protection of offshore oil and gas operations shall be independent from any functions relating to licensing of offshore oil and gas operations. Article 323 Cooperation on standards In accordance with Articles 92 and 98, the Parties shall promote cooperation between the regulators and standardisation bodies located within their respective territories to facilitate the development of international standards with respect to energy efficiency and renewable energy, with a view to contributing to sustainable energy and climate policy. Article 324 Research, development and innovation The Parties shall promote research, development and innovation in the areas of energy efficiency and renewable energy. CHAPTER 4 ENERGY GOODS AND RAW MATERIALS Article 325 Export pricing A Party shall not impose a higher price for exports of energy goods or raw materials to the other Party than the price charged for those energy goods or raw materials when destined for the domestic market, by means of any measures such as licences or minimum price requirements. Article 326 Regulated pricing If a Party decides to regulate the price of the domestic supply to consumers of electricity or natural gas, it may do so only to achieve a public policy objective, and only by imposing a regulated price that is clearly defined, transparent, non-discriminatory and proportionate. Article 327 Authorisation for exploration and production of hydrocarbons and generation of electricity 1. If a Party requires an authorisation for exploration or production of hydrocarbons or generation of electricity, that Party shall grant such authorisations on the basis of objective and non-discriminatory criteria which are drawn up and published before the start of the period for submission of applications in accordance with the general conditions and procedures set out in Section 1 of Chapter 5 of Title II of this Heading. 2. Notwithstanding paragraph 1 of this Article and Article 301, each Party may grant authorisations related to exploration for or the production of hydrocarbons without complying with the conditions and procedures related to publication set out in Article 153 on the basis of duly justified exemptions as provided for in applicable legislation. 3. Financial contributions or contributions in kind required from entities to which an authorisation is granted shall not interfere with the management and decision-making process of such entities. 4. Each Party shall provide that an applicant for authorisation has the right to appeal any decision concerning the authorisation to an authority higher than or independent from the authority that issued the decision or to request that such a higher or independent authority review that decision. Each Party shall ensure that the applicant is provided with the reasons for the administrative decision to enable the applicant to have recourse to the procedures for appeal or review if necessary. The applicable rules for appeal or review shall be published. Article 328 Safety and integrity of energy equipment and infrastructure This Title shall not be construed as preventing a Party from adopting temporary measures necessary to protect the safety and preserve the integrity of energy equipment or infrastructure, provided that those measures are not applied in a manner which would constitute a disguised restriction on trade or investment between the Parties. CHAPTER 5 FINAL PROVISIONS Article 329 Effective implementation and amendments 1. The Partnership Council may amend Annex 26 and Annex 28. The Partnership Council may update Annex 27 as necessary to ensure the operation of that Annex over time. 2. The Specialised Committee on Energy may amend Annex 29. 3. The Specialised Committee on Energy shall make recommendations as necessary to ensure the effective implementation of the Chapters of this Title for which it is responsible. Article 330 Dialogue The Parties shall establish a regular dialogue to facilitate meeting the objectives of this Title. Article 331 Termination of this Title 1. This Title shall cease to apply on 30 June 2026. 2. Notwithstanding paragraph 1, between 1 July 2026 and 31 December 2026, the Partnership Council may decide that this Title will apply until 31 March 2027. Between 1 April 2027 and 31 December 2027, as well as at any point of time in any subsequent year, the Partnership Council may decide that this Title will apply until 31 March of the following year. 3. This Article applies without prejudice to Articles 509, 521 and 779. TITLE IX TRANSPARENCY Article 332 Objective 1. Recognising the impact that their respective regulatory environments may have on trade and investment between them, the Parties aim to provide a predictable regulatory environment and efficient procedures for economic operators, especially for small and medium-sized enterprises. 2. The Parties affirm their commitments in relation to transparency under the WTO Agreement, and build on those commitments in the provisions laid down in this Title. Article 333 Definition For the purposes of this Title, "administrative decision" means a decision or action with legal effect that applies to a specific person, good or service in an individual case, and covers the failure to take a decision or take such action when that is so required by the law of a Party. Article 334 Scope This Title applies with respect to Titles I to VIII and Titles X to XII of this Heading and Heading Six. Article 335 Publication 1. Each Party shall ensure that its laws, regulations, procedures and administrative rulings of general application are promptly published via an officially designated medium, and, where feasible, by electronic means, or are otherwise made available in such a manner as to enable any person to become acquainted with them. 2. To the extent appropriate, each Party shall provide an explanation of the objective of and rationale for measures referred to in paragraph 1. 3. Each Party shall provide a reasonable period of time between publication and entry into force of its laws and regulations, except when this is not possible for reasons of urgency. Article 336 Enquiries 1. Each Party shall establish or maintain appropriate and proportionate mechanisms for responding to questions from any person regarding any laws or regulations. 2. Each Party shall promptly provide information and respond to questions by the other Party pertaining to any law or regulation whether in force or planned, unless a specific mechanism is established under another provision of this Agreement. Article 337 Administration of measures of general application 1. Each Party shall administer its laws, regulations, procedures and administrative rulings of general application in an objective, impartial, and reasonable manner. 2. When administrative proceedings relating to persons, goods or services of the other Party are initiated in respect of the application of laws or regulations, each Party shall: (a) endeavour to provide persons who are directly affected by the administrative proceedings with reasonable notice in accordance with its laws and regulations, including a description of the nature of the proceedings, a statement of the legal authority under which the proceedings are initiated and a general description of any issues in controversy; and (b) afford such persons a reasonable opportunity to present facts and arguments in support of their positions prior to any final administrative decision insofar as time, the nature of the proceedings and the public interest permit. Article 338 Review and appeal 1. Each Party shall establish or maintain judicial, arbitral or administrative tribunals and procedures for the purpose of the prompt review and, if warranted, correction of administrative decisions. Each Party shall ensure that its tribunals carry out procedures for appeal or review in a non-discriminatory and impartial manner. Those tribunals shall be impartial and independent of the authority entrusted with administrative enforcement. 2. Each Party shall ensure that the parties to the proceedings as referred to in paragraph 1 are provided with a reasonable opportunity to support or defend their respective positions. 3. In accordance with its law, each Party shall ensure that any decisions adopted in proceedings as referred to in paragraph 1 are based on the evidence and submissions of record or, where applicable, on the record compiled by the competent administrative authority. 4. Each Party shall ensure that decisions as referred to in paragraph 3 shall be implemented by the authority entrusted with administrative enforcement, subject to appeal or further review as provided for in its law. Article 339 Relation to other Titles The provisions set out in this Title supplement the specific transparency rules set out in those Titles of this Heading with respect to which this Title applies. TITLE X GOOD REGULATORY PRACTICES AND REGULATORY COOPERATION Article 340 General principles 1. Each Party shall be free to determine its approach to good regulatory practices under this Agreement in a manner consistent with its own legal framework, practice, procedures and fundamental principles (49) underlying its regulatory system. 2. Nothing in this Title shall be construed as requiring a Party to: (a) deviate from its domestic procedures for preparing and adopting regulatory measures; (b) take actions that would undermine or impede the timely adoption of regulatory measures to achieve its public policy objectives; or (c) achieve any particular regulatory outcome. 3. Nothing in this Title shall affect the right of a Party to define or regulate its own levels of protection in pursuit or furtherance of its public policy objectives in areas such as: (a) public health; (b) human, animal or plant life and health, and animal welfare; (c) occupational health and safety; (d) labour conditions; (e) environment including climate change; (f) consumer protection; (g) social protection and social security; (h) data protection and cybersecurity; (i) cultural diversity; (j) integrity and stability of the financial system, and protection of investors; (k) energy security; and (l) anti-money laundering. For greater certainty, for the purposes of in particular point (c) and (d) of the first subparagraph, the different models of industrial relations, including the role and autonomy of social partners, as provided for in the law or national practices of a Party, shall continue to apply, including laws and practices concerning collective bargaining and the enforcement of collective agreements. 4. Regulatory measures shall not constitute a disguised barrier to trade. Article 341 Definitions For the purposes of this Title, the following definitions apply: (a) "regulatory authority" means: (i) for the Union, the European Commission; and (ii) for the United Kingdom, Her Majesty's Government of the United Kingdom of Great Britain and Northern Ireland, and the devolved administrations of the United Kingdom. (b) "regulatory measures" means: (i) for the Union: (A) regulations and directives, as provided for in Article 288 TFEU; and (B) implementing and delegated acts, as provided for in Articles 290 and 291 TFEU, respectively; and (ii) for the United Kingdom: (A) primary legislation; and (B) secondary legislation. Article 342 Scope 1. This Title applies to regulatory measures proposed or issued, as relevant, by the regulatory authority of each Party in respect of any matter covered by Titles I to IX, Title XI and Title XII of this Heading and Heading Six. 2. Articles 351 and 352 also apply to other measures of general application issued or proposed by the regulatory authority of a Party in respect of any matter covered by the Titles referred to in paragraph 1 of this Article which are relevant to regulatory cooperation activities, such as guidelines, policy documents or recommendations. 3. This Title does not apply to regulatory authorities and regulatory measures, regulatory practices or approaches of the Member States. 4. Any specific provisions in the Titles referred to in paragraph 1 of this Article shall prevail over the provisions of this Title to the extent necessary for the application of the specific provisions. Article 343 Internal coordination Each Party shall have in place internal coordination or review processes or mechanisms with respect to regulatory measures that its regulatory authority is preparing. Such processes or mechanisms should seek, inter alia, to: (a) foster good regulatory practices, including those set forth in this Title; (b) identify and avoid unnecessary duplication and inconsistent requirements between the Party's own regulatory measures; (c) ensure compliance with the Party's international trade and investment obligations; and (d) promote the consideration of the impact of the regulatory measures under preparation, including the impact on small and medium-sized enterprises (50), in accordance with its respective rules and procedures. Article 344 Description of processes and mechanisms Each Party shall make publicly available descriptions of the processes or mechanisms used by its regulatory authority to prepare, evaluate or review regulatory measures. Those descriptions shall refer to relevant rules, guidelines or procedures, including those regarding opportunities for the public to provide comments. Article 345 Early information on planned regulatory measures 1. Each Party shall make publicly available, in accordance with its respective rules and procedures on at least an annual basis, a list of planned major (51) regulatory measures that its regulatory authority reasonably expects to propose or adopt within a year. The regulatory authority of each Party may determine what constitutes a major regulatory measure for the purposes of its obligations under this Title. 2. With respect to each major regulatory measure included in the list referred to in paragraph 1, each Party should also make publicly available, as early as possible: (a) a brief description of its scope and objectives; and (b) if available, the estimated time for its adoption, including any opportunities for public consultation. Article 346 Public consultation 1. When preparing a major regulatory measure, each Party, in accordance with its respective rules and procedures, shall ensure that its regulatory authority: (a) publishes either the draft regulatory measure or consultation documents providing sufficient details about the regulatory measure under preparation to allow any person to assess whether and how that person's interests might be significantly affected; (b) offers, on a non-discriminatory basis, reasonable opportunities for any person to provide comments; and (c) considers the comments received. 2. Each Party shall ensure that its regulatory authority makes use of electronic means of communication and shall seek to maintain online services that are available to the public free of charge for the purposes of publishing the relevant regulatory measures or documents of the kind referred to in point (a) of paragraph 1 and of receiving comments related to public consultations. 3. Each Party shall ensure that its regulatory authority makes publicly available, in accordance with its respective rules and procedures, a summary of the results of the public consultations referred to in this Article. Article 347 Impact assessment 1. Each Party affirms its intention to ensure that its regulatory authority carries out, in accordance with its respective rules and procedures, impact assessments for any major regulatory measures it prepares. Such rules and procedures may provide for exceptions. 2. When carrying out an impact assessment, each Party shall ensure that its regulatory authority has processes and mechanisms in place that promote the consideration of the following factors: (a) the need for the regulatory measure, including the nature and the significance of the problem that the regulatory measure intends to address; (b) any feasible and appropriate regulatory or non-regulatory options that would achieve the Party's public policy objectives, including the option of not regulating; (c) to the extent possible and relevant, the potential social, economic and environmental impact of those options, including the impact on international trade and investment and, in accordance with its respective rules and procedures, the impact on small and medium-sized enterprises; and (d) where appropriate, how the options under consideration relate to relevant international standards, including the reasons for any divergence. 3. With respect to an impact assessment that a regulatory authority has conducted for a regulatory measure, each Party shall ensure that its regulatory authority prepares a final report detailing the factors it considered in its assessment and its relevant findings. To the extent possible, each Party shall make such reports publicly available no later than when the proposal for a regulatory measure as referred to in point (b)(i)(A) or (b)(ii)(A) of Article 341 or a regulatory measure as referred to in point (b)(i)(B) or (b)(ii)(B) of that Article has been made publicly available. Article 348 Retrospective evaluation 1. Each Party shall ensure that its regulatory authority has in place processes or mechanisms for the purpose of carrying out periodic retrospective evaluations of regulatory measures in force, where appropriate. 2. When conducting a periodic retrospective evaluation, each Party shall endeavour to consider whether there are opportunities to more effectively achieve its public policy objectives and to reduce unnecessary regulatory burdens, including on small and medium-sized enterprises. 3. Each Party shall ensure that its regulatory authority makes publicly available any existing plans for and the results of such retrospective evaluations. Article 349 Regulatory register Each Party shall ensure that regulatory measures that are in effect are published in a designated register that identifies regulatory measures and that is publicly available online free of charge. The register should allow searches for regulatory measures by citations or by word. Each Party shall periodically update its register. Article 350 Exchange of information on good regulatory practices The Parties shall endeavour to exchange information on their good regulatory practices as set out in this Title, including in the Trade Specialised Committee on Regulatory Cooperation. Article 351 Regulatory cooperation activities 1. The Parties may engage in regulatory cooperation activities on a voluntary basis, without prejudice to the autonomy of their own decision-making and their respective legal orders. A Party may refuse to engage in or it may withdraw from regulatory cooperation activities. A Party that refuses to engage in or that withdraws from regulatory cooperation activities should explain the reasons for its decision to the other Party. 2. Each Party may propose a regulatory cooperation activity to the other Party. It shall present its proposal via the contact point designated in accordance with Article 353. The other Party shall review that proposal within a reasonable period and shall inform the proposing Party whether it considers the proposed activity to be suitable for regulatory cooperation. 3. In order to identify activities that are suitable for regulatory cooperation, each Party shall consider: (a) the list referred to in Article 345(1); and (b) proposals for regulatory cooperation activities submitted by persons of a Party that are substantiated and accompanied by relevant information. 4. If the Parties decide to engage in a regulatory cooperation activity, the regulatory authority of each Party shall endeavour, where appropriate: (a) to inform the regulatory authority of the other Party about the preparation of new or the revision of existing regulatory measures and other measures of general application referred to in Article 342(2) that are relevant to the regulatory cooperation activity; (b) on request, to provide information and discuss regulatory measures and other measures of general application referred to in Article 342(2) that are relevant to the regulatory cooperation activity; and (c) when preparing new or revising existing regulatory measures or other measures of general application referred to in Article 342(2), consider, to the extent feasible, any regulatory approach by the other Party on the same or a related matter. Article 352 Trade Specialised Committee on Regulatory Cooperation 1. The Trade Specialised Committee on Regulatory Cooperation shall have the following functions: (a) enhancing and promoting good regulatory practices and regulatory cooperation between the Parties; (b) exchanging views with respect to the cooperation activities proposed or carried out under Article 351; (c) encouraging regulatory cooperation and coordination in international fora, including, when appropriate, periodic bilateral exchanges of information on relevant ongoing or planned activities. 2. The Trade Specialised Committee on Regulatory Cooperation may invite interested persons to participate in its meetings. Article 353 Contact points Within a month after the entry into force of this Agreement, each Party shall designate a contact point to facilitate the exchange of information between the Parties. Article 354 Non-application of dispute settlement Title I of Part Six does not apply in respect of disputes regarding the interpretation and application of this Title. TITLE XI LEVEL PLAYING FIELD FOR OPEN AND FAIR COMPETITION AND SUSTAINABLE DEVELOPMENT CHAPTER 1 GENERAL PROVISIONS Article 355 Principles and objectives 1. The Parties recognise that trade and investment between the Union and the United Kingdom under the terms set out in this Agreement, require conditions that ensure a level playing field for open and fair competition between the Parties and that ensure that trade and investment take place in a manner conducive to sustainable development. 2. The Parties recognise that sustainable development encompasses economic development, social development and environmental protection, all three being interdependent and mutually reinforcing, and affirm their commitment to promoting the development of international trade and investment in a way that contributes to the objective of sustainable development. 3. Each Party reaffirms its ambition of achieving economy-wide climate neutrality by 2050. 4. The Parties affirm their common understanding that their economic relationship can only deliver benefits in a mutually satisfactory way if the commitments relating to a level playing field for open and fair competition stand the test of time, by preventing distortions of trade or investment, and by contributing to sustainable development. However the Parties recognise that the purpose of this Title is not to harmonise the standards of the Parties. The Parties are determined to maintain and improve their respective high standards in the areas covered by this Title. Article 356 Right to regulate, precautionary approach (52) and scientific and technical information 1. The Parties affirm the right of each Party to set its policies and priorities in the areas covered by this Title, to determine the levels of protection it deems appropriate and to adopt or modify its law and policies in a manner consistent with each Party's international commitments, including its commitments under this Title. 2. The Parties acknowledge that, in accordance with the precautionary approach, where there are reasonable grounds for concern that there are potential threats of serious or irreversible damage to the environment or human health, the lack of full scientific certainty shall not be used as a reason for preventing a Party from adopting appropriate measures to prevent such damage. 3. When preparing or implementing measures aimed at protecting the environment or labour conditions that may affect trade or investment, each Party shall take into account relevant and available scientific and technical information, international standards, guidelines and recommendations. Article 357 Dispute settlement Title I of Part Six does not apply to this Chapter, except for Article 356(2). Articles 408 and 409 apply to Article 355(3). CHAPTER 2 COMPETITION POLICY Article 358 Principles and definitions 1. The Parties recognise the importance of free and undistorted competition in their trade and investment relations. The Parties acknowledge that anticompetitive business practices may distort the proper functioning of markets and undermine the benefits of trade liberalisation. 2. For the purposes of this Chapter, an "economic actor" means an entity or a group of entities constituting a single economic entity, regardless of its legal status, that is engaged in an economic activity by offering goods or services on a market. Article 359 Competition law 1. In recognition of the principles set out in Article 358, each Party shall maintain a competition law which effectively addresses the following anticompetitive business practices: (a) agreements between economic actors, decisions by associations of economic actors and concerted practices which have as their object or effect the prevention, restriction or distortion of competition; (b) abuse by one or more economic actors of a dominant position; and (c) for the United Kingdom, mergers or acquisitions and, for the Union, concentrations, between economic actors which may have significant anticompetitive effects. 2. The competition law referred to in paragraph 1 shall apply to all economic actors irrespective of their nationality or ownership status. 3. Each Party may provide for exemptions from its competition law in pursuit of legitimate public policy objectives, provided that those exemptions are transparent and are proportionate to those objectives. Article 360 Enforcement 1. Each Party shall take appropriate measures to enforce its competition law in its territory. 2. Each Party shall maintain an operationally independent authority or authorities competent for the effective enforcement of its competition law. 3. Each Party shall apply its competition law in a transparent and non-discriminatory manner, respecting the principles of procedural fairness, including the rights of defence of the economic actors concerned, irrespective of their nationality or ownership status. Article 361 Cooperation 1. To achieve the objectives of this Chapter and to enhance the effective enforcement of their respective competition law, the Parties recognise the importance of cooperation between their respective competition authorities with regard to developments in competition policy and enforcement activities. 2. For the purposes of paragraph 1, the European Commission or the competition authorities of the Member States, on the one side, and the United Kingdom's competition authority or authorities, on the other side, shall endeavour to cooperate and coordinate, with respect to their enforcement activities concerning the same or related conduct or transactions, where doing so is possible and appropriate. 3. To facilitate the cooperation and coordination referred to in paragraphs 1 and 2, the European Commission and the competition authorities of the Member States, on the one side, and the United Kingdom's competition authority or authorities, on the other side, may exchange information to the extent permitted by each Party's law. 4. To implement the objectives of this Article, the Parties may enter into a separate agreement on cooperation and coordination between the European Commission, the competition authorities of the Member States and the United Kingdom's competition authority or authorities, which may include conditions for the exchange and use of confidential information. Article 362 Dispute settlement This Chapter shall not be subject to dispute settlement under Title I of Part Six. CHAPTER 3 SUBSIDY CONTROL Article 363 Definitions 1. For the purposes of this Chapter, the following definitions apply: (a) "economic actor" means an entity or a group of entities constituting a single economic entity, regardless of its legal status, that is engaged in an economic activity by offering goods or services on a market; (b) "subsidy" means financial assistance which: (i) arises from the resources of the Parties, including: (A) a direct or contingent transfer of funds such as direct grants, loans or loan guarantees; (B) the forgoing of revenue that is otherwise due; or (C) the provision of goods or services, or the purchase of goods or services; (ii) confers an economic advantage on one or more economic actors; (iii) is specific insofar as it benefits, as a matter of law or fact, certain economic actors over others in relation to the production of certain goods or services; and (iv) has, or could have, an effect on trade or investment between the Parties. 2. For the purposes of point (b)(iii) of paragraph 1: (a) a tax measure shall not be considered as specific unless: (i) certain economic actors obtain a reduction in the tax liability that they otherwise would have borne under the normal taxation regime; and (ii) those economic actors are treated more advantageously than others in a comparable position within the normal taxation regime; for the purposes of this point, a normal taxation regime is defined by its internal objective, by its features (such as the tax base, the taxable person, the taxable event or the tax rate) and by an authority which is autonomous institutionally, procedurally, economically and financially and has the competence to design the features of the taxation regime; (b) notwithstanding point (a), a subsidy shall not be regarded as specific if it is justified by principles inherent to the design of the general system; in the case of tax measures, examples of such inherent principles are the need to fight fraud or tax evasion, administrative manageability, the avoidance of double taxation, the principle of tax neutrality, the progressive nature of income tax and its redistributive purpose, or the need to respect taxpayers' ability to pay; (c) notwithstanding point (a), special purpose levies shall not be regarded as specific if their design is required by non-economic public policy objectives, such as the need to limit the negative impacts of certain activities or products on the environment or human health, insofar as the public policy objectives are not discriminatory (53). Article 364 Scope and exceptions 1. Articles 366, 367 and 374 do not apply to subsidies granted to compensate the damage caused by natural disasters or other exceptional non-economic occurrences. 2. Nothing in this Chapter prevents the Parties from granting subsidies of a social character that are targeted at final consumers. 3. Subsidies that are granted on a temporary basis to respond to a national or global economic emergency shall be targeted, proportionate and effective in order to remedy that emergency. Articles 367 and 374 do not apply to such subsidies. 4. This Chapter does not apply to subsidies where the total amount granted to a single economic actor is below 325 000 Special Drawing Rights over any period of three fiscal years. The Partnership Council may amend this threshold. 5. This Chapter does not apply to subsidies that are subject to the provisions of Part IV or Annex 2 of the Agreement on Agriculture and subsidies related to trade in fish and fish products. 6. This Chapter does not apply to subsidies related to the audio-visual sector. 7. Article 371 does not apply to subsidies financed by resources of a Party at supranational level. 8. For the purposes of subsidies to air carriers, any reference to "effect on trade or investment between the Parties" in this Chapter shall be read as "effect on competition between air carriers of the Parties in the provision of air transport services", including those air transport services not covered under Title I of Heading Two. Article 365 Services of public economic interest 1. Subsidies granted to economic actors assigned with particular tasks in the public interest, including public service obligations, are subject to Article 366 insofar as the application of the principles set out in that Article does not obstruct the performance in law or fact of the particular task assigned to the economic actor concerned. The task shall be assigned in advance in a transparent manner. 2. The Parties shall ensure that the amount of compensation granted to an economic actor that is assigned with a task in the public interest is limited to what is necessary to cover all or part of the costs incurred in the discharge of that task, taking into account the relevant receipts and a reasonable profit for discharging that task. The Parties shall ensure that the compensation granted is not used to cross-subsidise activities falling outside the scope of the assigned task. Compensation below 15 million Special Drawing Rights per task shall not be subject to the obligations under Article 369. The Partnership Council may amend this threshold. 3. This Chapter does not apply where the total compensation to an economic actor providing tasks in the public interest is below 750 000 Special Drawing Rights over any period of three fiscal years. The Partnership Council may amend this threshold. Article 366 Principles 1. With a view to ensuring that subsidies are not granted where they have or could have a material effect on trade or investment between the Parties, each Party shall have in place and maintain an effective system of subsidy control that ensures that the granting of a subsidy respects the following principles: (a) subsidies pursue a specific public policy objective to remedy an identified market failure or to address an equity rationale such as social difficulties or distributional concerns ("the objective"); (b) subsidies are proportionate and limited to what is necessary to achieve the objective; (c) subsidies are designed to bring about a change of economic behaviour of the beneficiary that is conducive to achieving the objective and that would not be achieved in the absence of subsidies being provided; (d) subsidies should not normally compensate for the costs the beneficiary would have funded in the absence of any subsidy; (e) subsidies are an appropriate policy instrument to achieve a public policy objective and that objective cannot be achieved through other less distortive means; (f) subsidies' positive contributions to achieving the objective outweigh any negative effects, in particular the negative effects on trade or investment between the Parties. 2. Without prejudice to paragraph 1 of this Article, each Party shall apply the conditions set out in Article 367, where relevant, if the subsidies concerned have or could have a material effect on trade or investment between the Parties. 3. It is for each Party to determine how its obligations under paragraphs 1 and 2 are implemented in the design of its subsidy control system in its own domestic law, provided that each Party shall ensure that the obligations under paragraphs 1 and 2 are implemented in its law in such a manner that the legality of an individual subsidy will be determined by the principles. Article 367 Prohibited subsidies and subsidies subject to conditions 1. The categories of the subsidies referred to in Article 366(2) and the conditions to be applied to them are as follows. The Partnership Council may update these provisions as necessary to ensure the operation of this Article over time. Subsidies in the form of unlimited guarantees 2. Subsidies in the form of a guarantee of debts or liabilities of an economic actor without any limitation as to the amount of those debts and liabilities or the duration of that guarantee shall be prohibited. Rescue and restructuring 3. Subsidies for restructuring an ailing or insolvent economic actor without the economic actor having prepared a credible restructuring plan shall be prohibited. The restructuring plan shall be based on realistic assumptions with a view to ensuring the return to long-term viability of the ailing or insolvent economic actor within a reasonable time period. During the preparation of the restructuring plan, the economic actor may receive temporary liquidity support in the form of loans or loan guarantees. Except for small and medium-sized enterprises, an economic actor or its owners, creditors or new investors shall contribute significant funds or assets to the cost of restructuring. For the purposes of this paragraph, an ailing or insolvent economic actor is one that would almost certainly go out of business in the short to medium term without the subsidy. 4. Other than in exceptional circumstances, subsidies for the rescue and restructuring of insolvent or ailing economic actors should only be allowed if they contribute to an objective of public interest by avoiding social hardship or preventing a severe market failure, in particular with regard to job losses or disruption of an important service that is difficult to replicate. Except in the case of unforeseeable circumstances not caused by the beneficiary, they should not be granted more than once in any five year period. 5. Paragraphs 3 and 4 do not apply to subsidies to ailing or insolvent banks, credit institutions and insurance companies. Banks, credit institutions and insurance companies 6. Without prejudice to Article 184, subsidies to restructure banks, credit institutions and insurance companies may only be granted on the basis of a credible restructuring plan that restores long-term viability. If a return to long-term viability cannot be credibly demonstrated, any subsidy to banks, credit institutions and insurance companies shall be limited to what is needed to ensure their orderly liquidation and exit from the market while minimising the amount of the subsidy and its negative effect on trade or investment between the Parties. 7. It shall be ensured that the granting authority is properly remunerated for the restructuring subsidy and that the beneficiary, its shareholders, its creditors or the business group to which the beneficiary belongs, contribute significantly to the restructuring or liquidation costs from their own resources. Subsidies to support liquidity provisions shall be temporary, shall not be used to absorb losses and shall not become capital support. Proper remuneration shall be paid to the granting authority for the subsidies granted to support liquidity provisions. Export subsidies 8. Subsidies that are contingent in law or in fact (54), whether solely or as one of several other conditions, upon export performance relating to goods or services, shall be prohibited, except in relation to: (a) short-term credit insurance for non-marketable risks; or (b) export credits and export credit guarantee or insurance programmes that are permissible in accordance with the SCM Agreement, read with any adjustments necessary for context. 9. For the purposes of point (a) of paragraph 8, "marketable risk" means commercial and political risks with a maximum risk period of less than two years on public and non-public buyers in marketable risk countries (55). A country may be understood to be temporarily removed from the group of marketable risk countries if there is a lack of sufficient private market capacity because of: (a) a significant contraction of private credit insurance capacity; (b) a significant deterioration of sovereign sector rating; or (c) a significant deterioration of corporate sector performance. 10. Such temporary removal of a marketable risk country shall take effect, as far as a Party is concerned, in accordance with a decision of that Party on the basis of the criteria in paragraph 9, and only if that Party adopts such a decision. The publication of that decision shall be deemed to constitute notice to the other Party of such temporary removal as far as the former Party is concerned. 11. If a subsidised insurer provides export credit insurance, any insurance for marketable risks shall be provided on a commercial basis. In such a case, the insurer shall not directly or indirectly benefit from subsidies for the provision of insurance for marketable risks. Subsidies contingent upon the use of domestic content 12. Without prejudice to Articles 132 and 133, subsidies contingent, whether solely or as one of several other conditions, upon the use of domestic over imported goods or services shall be prohibited. Large cross-border or international cooperation projects 13. Subsidies may be granted in the context of large cross-border or international cooperation projects, such as those for transport, energy, the environment, research and development, and first deployment projects to incentivise the emergence and deployment of new technologies (excluding manufacturing). The benefits of such cross-border or international cooperation projects must not be limited to the economic actors or to the sector or the States participating, but must have wider benefit and relevance through spillover effects that do not exclusively accrue to the State that grants the subsidy, the relevant sector and beneficiary. Energy and environment 14. The Parties recognise the importance of a secure, affordable and sustainable energy system and environmental sustainability, notably in relation to the fight against climate change which represents an existential threat to humanity. Therefore, without prejudice to Article 366, subsidies in relation to energy and environment shall be aimed at, and incentivise the beneficiary in, delivering a secure, affordable and sustainable energy system and a well-functioning and competitive energy market or increasing the level of environmental protection compared to the level that would be achieved in absence of the subsidy. Such subsidies shall not relieve the beneficiary from liabilities arising from its responsibilities as a polluter under the law of the relevant Party. Subsidies to air carriers for the operation of routes 15. Subsidies shall not be granted to an air carrier (56) for the operation of routes except: (a) where there is a public service obligation, in accordance with Article 365; (b) in special cases where this funding provides benefits for society at large; or (c) as start-up subsidies for opening new routes to regional airports provided that such subsidies increase the mobility of citizens and stimulate regional development. Article 368 Use of subsidies Each Party shall ensure that economic actors use subsidies only for the specific purpose for which they are granted. Article 369 Transparency 1. With respect to any subsidy granted or maintained within its territory, each Party shall within six months from the granting of the subsidy make publicly available, on an official website or a public database, the following information: (a) the legal basis and policy objective or purpose of the subsidy; (b) the name of the recipient of the subsidy when available; (c) the date of the grant of the subsidy, the duration of the subsidy and any other time limits attached to the subsidy; and (d) the amount of the subsidy or the amount budgeted for the subsidy. 2. For subsidies in the form of tax measures, information shall be made public within one year from the date the tax declaration is due. The transparency obligations for subsidies in the form of tax measures concern the same information as listed in paragraph 1, except for the information required under point (d) of that paragraph, which may be provided as a range. 3. In addition to the obligation set out in paragraph 1, the Parties shall make subsidy information available in accordance with paragraph 4 or 5. 4. For the Union, compliance with paragraph 3 of this Article means that with respect to any subsidy granted or maintained within its territory, within six months from the grant of the subsidy, information is made publicly available, on an official website or a public database, that allows interested parties to assess compliance with the principles set out in Article 366. 5. For the United Kingdom, compliance with paragraph 3 means that the United Kingdom shall ensure that: (a) if an interested party communicates to the granting authority that it may apply for a review by a court or tribunal of: (i) the grant of a subsidy by a granting authority; or (ii) any relevant decision by the granting authority or the independent body or authority; (b) then, within 28 days of the request being made in writing, the granting authority, independent body or authority shall provide that interested party with the information that allows the interested party to assess the application of the principles set out in Article 366, subject to any proportionate restrictions which pursue a legitimate objective, such as commercial sensitivity, confidentiality or legal privilege. The information referred to in point (b) of the first subparagraph shall be provided to the interested party for the purposes of enabling it to make an informed decision as to whether to make a claim or to understand and properly identify the issues in dispute in the proposed claim. 6. For the purposes of this Article and Articles 372 and 373, "interested party" means any natural or legal person, economic actor or association of economic actors whose interest might be affected by the granting of a subsidy, in particular the beneficiary, economic actors competing with the beneficiary or relevant trade associations. 7. The obligations in this Article are without prejudice to the obligations of the Parties under their respective laws concerning the freedom of information or access to documents. Article 370 Consultations on subsidy control 1. If a Party considers that a subsidy has been granted by the other Party or that there is clear evidence that the other Party intends to grant a subsidy and that the granting of the subsidy has or could have a negative effect on trade or investment between the Parties, it may request to the other Party to provide an explanation of how the principles set out in Article 366 have been respected with regard to that subsidy. 2. A Party may also request the information listed in Article 369(1) to the extent that the information has not already been made publicly available on an official website or a public database as referred to in Article 369(1), or to the extent that the information has not been made available in an easily and readily accessible manner. 3. The other Party shall provide the requested information in writing no later than 60 days of the receipt of the request. If any requested information cannot be provided, that Party shall explain the absence of such information in its written response. 4. If after receiving the information requested, the requesting Party still considers that the subsidy granted or intended to be granted by the other Party has or could have a negative effect on trade or investment between the Parties, the requesting Party may request consultations within the Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development. The request shall be in writing and shall include an explanation of the requesting Party's reasons for requesting the consultation. 5. The Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development shall make every attempt to arrive at a mutually satisfactory resolution of the matter. It shall hold its first meeting within 30 days of the request for consultation. 6. The timeframes for the consultations referred to in paragraphs 3 and 5 may be extended by agreement between the Parties. Article 371 Independent authority or body and cooperation 1. Each Party shall establish or maintain an operationally independent authority or body with an appropriate role in its subsidy control regime. That independent authority or body shall have the necessary guarantees of independence in exercising its operational functions and shall act impartially. 2. The Parties shall encourage their respective independent authorities or bodies to cooperate with each other on issues of common interest within their respective functions, including the application of Articles 363 to 369 as applicable, within the limits established by their respective legal frameworks. The Parties, or their respective independent authorities or bodies, may agree upon a separate framework regarding cooperation between those independent authorities. Article 372 Courts and tribunals 1. Each Party shall ensure, in accordance with its general and constitutional laws and procedures, that its courts or tribunals are competent to: (a) review subsidy decisions taken by a granting authority or, where relevant, the independent authority or body for compliance with that Party's law implementing Article 366; (b) review any other relevant decisions of the independent authority or body and any relevant failure to act; (c) impose remedies that are effective in relation to point (a) or (b), including the suspension, prohibition or requirement of action by the granting authority, the award of damages, and the recovery of a subsidy from its beneficiary, if and to the extent that those remedies are available under the respective laws on the date of entry into force of this Agreement; (d) hear claims from interested parties in respect of subsidies that are subject to this Chapter where an interested party has standing to bring a claim in respect of a subsidy under that Party's law. 2. Each Party shall have the right to intervene with the permission, where required, of the court or tribunal concerned, in accordance with the general laws and procedures of the other Party in cases referred to in paragraph 1. 3. Without prejudice to the obligations to maintain or, where necessary, to create the competencies, remedies and rights of intervention referred to in paragraphs 1 and 2 of this Article, and Article 373, nothing in this Article requires either Party to create rights of action, remedies, procedures, or widen the scope or grounds of review of decisions of their respective public authorities, beyond those existing under its law on the date of entry into force of this Agreement. 4. Nothing in this Article requires either Party to widen the scope or grounds of review by its courts and tribunals of Acts of the United Kingdom Parliament, of acts of the European Parliament and the Council of the European Union, or of acts of the Council of the European Union beyond those existing under its law on the date of entry into force of this Agreement. (57) Article 373 Recovery 1. Each Party shall have in place an effective mechanism of recovery in respect of subsidies in accordance with the following provisions, without prejudice to other remedies that exist in that Party's law. (58) 2. Each Party shall ensure that, provided that the interested party as defined in Article 369 has challenged a decision to grant a subsidy before a court or a tribunal within the specified time period, as defined in paragraph 3 of this Article, recovery may be ordered if a court or tribunal of a Party makes a finding of a material error of law, in that: (a) a measure constituting a subsidy was not treated by the grantor as a subsidy; (b) the grantor of a subsidy has failed to apply the principles set out in Article 366, as implemented in that Party's law, or applied them in a manner which falls below the standard of review applicable in that Party's law; or (c) the grantor of a subsidy has, by deciding to grant that subsidy, acted outside the scope of its powers or misused those powers in relation to the principles set out in Article 366, as implemented in that Party's law. 3. For the purposes of this Article, the specified time period shall be determined as follows: (a) for the Union, it shall commence on the date on which information specified in Article 369(1), (2) and (4) was made available on the official website or public database and be no shorter than one month. (b) for the United Kingdom: (i) it shall commence on the date on which information specified in Article 369(1) and (2) was made available on the official website or public database; (ii) it shall terminate one month later, unless, prior to that date, the interested party has requested information under the process specified in Article 369(5); (iii) once the interested party has received the information identified in point (b) of Article 369(5) sufficient for the purposes identified in Article 369(5), there shall be a further one month period at the end of which the specified time period shall terminate; (iv) the date of receipt of the information in point (iii) will be the date on which the granting authority certifies that it has provided the information identified in point (b) of Article 369(5) sufficient for those purposes, irrespective of further or clarificatory correspondence after that date; (v) the time periods identified in points (i), (ii) and (iii) may be increased by legislation. 4. For the purposes of point (b) of paragraph 3 in relation to schemes, the specified time period commences when the information under point (b) of this paragraph is published, not when subsequent payments are made, where: (a) a subsidy is ostensibly granted in accordance with the terms of a scheme; (b) the maker of the scheme has made publicly available the information required to be published by Article 369(1) and (2) in respect of the scheme; and (c) the information provided about the scheme under point (b) of this paragraph contains information about the subsidy that would enable an interested party to determine whether it may be affected by the scheme, which at a minimum shall cover the purpose of the subsidy, the categories of beneficiary, the terms and conditions of eligibility for the subsidy and the basis for the calculation of the subsidy (including any relevant conditions relating to subsidy ratios or amounts). 5. For the purposes of this Article, recovery of a subsidy is not required where a subsidy is granted on the basis of an Act of the Parliament of the United Kingdom, of an act of the European Parliament and of the Council of the European Union or of an act of the Council of the European Union. 6. Nothing in this Article prevents a Party from choosing to provide additional situations where recovery is a remedy, beyond those specified in this Article, in accordance with its law. 7. The Parties recognise that recovery is an important remedial tool in any system of subsidy control. At the request of either Party, the Parties shall within the Partnership Council consider additional or alternative mechanisms for recovery, as well as corresponding amendments to this Article. Within the Partnership Council, either Party may propose amendments to allow for different arrangements for their respective mechanisms for recovery. A Party shall consider a proposal made by the other Party in good faith and agree to it, provided that that Party considers that it contains arrangements which represent at least as effective a means of securing recovery as the existing mechanisms of the other Party. The Partnership Council may then make corresponding amendments to this Article. (59) Article 374 Remedial measures 1. A Party may deliver to the other Party a written request for information and consultations regarding a subsidy that it considers causes, or there is a serious risk that it will cause, a significant negative effect on trade or investment between the Parties. The requesting Party should provide in that request all relevant information to enable the Parties to find a mutually acceptable solution, including a description of the subsidy and the concerns of the requesting Party regarding its effect on trade or investment. 2. No later than 30 days from the date of delivery of the request, the requested Party shall deliver a written response providing the requested information to the requesting Party, and the Parties shall enter into consultations, which shall be deemed concluded 60 days from the date of delivery of that request, unless the Parties agree otherwise. Such consultations, and in particular all information designated as confidential and positions taken by the Parties during consultations, shall be confidential and shall be without prejudice to the rights of either Party in any further proceedings. 3. No earlier than 60 days from the date of delivery of the request referred to in paragraph 1, the requesting Party may unilaterally take appropriate remedial measures if there is evidence that a subsidy of the requested Party causes, or there is a serious risk that it will cause, a significant negative effect on trade or investment between the Parties. 4. No earlier than 45 days from the date of delivery of the request referred to in paragraph 1, the requesting Party shall notify the requested Party of the remedial measures that it intends to take in accordance with paragraph 3. The requesting Party shall provide all relevant information in relation to the measures that it intends to take to enable the Parties to find a mutually acceptable solution. The requesting Party may not take those remedial measures earlier than 15 days from the date of delivery of the notification of those measures to the requested Party. 5. A Party's assessment of the existence of a serious risk of a significant negative effect shall be based on facts and not merely on allegation, conjecture or remote possibility. The change in circumstances that would create a situation in which the subsidy would cause such a significant negative effect must be clearly predictable. 6. A Party's assessment of the existence of a subsidy or of a significant negative effect on trade or investment between the Parties caused by the subsidy shall be based on reliable evidence and not merely on conjecture or remote possibility, and shall relate to identifiable goods, service suppliers or other economic actors, including, if relevant, in the case of subsidy schemes. 7. The Partnership Council may maintain an illustrative list of what would amount to a significant negative effect on trade or investment between the Parties within the meaning of this Article. This shall be without prejudice to the right of the Parties to take remedial measures. 8. The remedial measures taken pursuant to paragraph 3 shall be restricted to what is strictly necessary and proportionate in order to remedy the significant negative effect caused or to address the serious risk of such an effect. Priority shall be given to measures that will least disturb the functioning of this Agreement. 9. Within five days from the date on which the remedial measures referred to in paragraph 3 enter into effect and without having prior recourse to consultations in accordance with Article 738, the notified Party may request, in accordance with Article 739(2), the establishment of an arbitration tribunal by means of a written request delivered to the requesting Party in order for the arbitration tribunal to decide whether: (a) a remedial measure taken by the requesting Party is inconsistent with paragraph 3 or 8; (b) the requesting Party did not participate in the consultations after the requested Party delivered the requested information and agreed to the holding of such consultations; or (c) there was a failure to take or notify a remedial measure in accordance with the time periods referred to in paragraph 3 or 4 respectively. That request shall not have a suspensive effect on the remedial measures. Furthermore, the arbitration tribunal shall not assess the application by the Parties of Articles 366 and 367. 10. The arbitration tribunal established following the request referred to in paragraph 9 of this Article shall conduct its proceedings in accordance with Article 760 and deliver its final ruling within 30 days from its establishment. 11. In the case of a finding against the respondent Party, the respondent Party shall, at the latest 30 days from the date of delivery of the ruling of the arbitration tribunal, deliver a notification to the complaining Party of any measure that it has taken to comply with that ruling. 12. Following a finding against the respondent Party in the procedure referred to paragraph 10 of this Article, the complaining Party may request the arbitration tribunal, within 30 days from its ruling, to determine a level of suspension of obligations under this Agreement or a supplementing agreement not exceeding the level equivalent to the nullification or impairment caused by the application of the remedial measures, if it finds that the inconsistency of the remedial measures with paragraph 3 or 8 of this Article is significant. The request shall propose a level of suspension of obligations in accordance with the principles set out in Article 761. The complaining Party may suspend obligations under this Agreement or a supplementing agreement in accordance with the level of suspension of obligations determined by the arbitration tribunal. Such suspension shall not be applied sooner than 15 days following such ruling. 13. A Party shall not invoke the WTO Agreement or any other international agreement to preclude the other Party from taking measures pursuant to this Article, including where those measures consist in the suspension of obligations under this Agreement or under a supplementing agreement. 14. For the purposes of assessing whether imposing or maintaining remedial measures on imports of the same product is restricted to what is strictly necessary or proportionate for the purposes of this Article, a Party: (a) shall take into account countervailing measures applied or maintained pursuant to Article 32(3); and (b) may take into account anti-dumping measures applied or maintained pursuant to Article 32(3). 15. A Party shall not apply simultaneously a remedial measure under this Article and a rebalancing measure under Article 411 to remedy the impact on trade or investment caused directly by the same subsidy. 16. If the Party against which remedial measures were taken does not submit a request pursuant to paragraph 9 of this Article within the time period laid down in that paragraph, that Party may initiate the arbitration procedure referred to in Article 739 to challenge a remedial measure on the grounds set out in paragraph 9 of this Article without having prior recourse to consultations in accordance with Article 738. An arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. 17. For the purposes of the proceedings under paragraphs 9 and 16, in assessing whether a remedial measure is strictly necessary or proportionate, the arbitration tribunal shall pay due regard to the principles set out in paragraphs 5 and 6, as well as to paragraphs 13, 14 and 15. Article 375 Dispute settlement 1. Subject to paragraphs 2 and 3 of this Article, Title I of Part Six applies to disputes between the Parties concerning the interpretation and application of this Chapter, except for Articles 371 and 372. 2. An arbitration tribunal shall have no jurisdiction regarding: (a) an individual subsidy, including whether such a subsidy has respected the principles set out in Article 366(1), other than with regard to the conditions set out in Article 367(2), Article 367(3), (4) and (5), Article 367(8) to (11) and Article 367(12); and (b) whether the recovery remedy within the meaning of Article 373 has been correctly applied in any individual case. 3. Title I of Part Six shall apply to Article 374 in accordance with that Article and Article 760. CHAPTER 4 STATE-OWNED ENTERPRISES, ENTERPRISES GRANTED SPECIAL RIGHTS OR PRIVILEGES AND DESIGNATED MONOPOLIES Article 376 Definitions 1. For the purposes of this Chapter, the following definitions apply: (a) "Arrangement" means the Arrangement on Officially Supported Export Credits, developed within the framework of the OECD or a successor undertaking, whether developed within or outside of the OECD framework, that has been adopted by at least 12 original WTO Members that were Participants to the Arrangement as of 1 January 1979; (b) "commercial activities" means activities, the end result of which is the production of a good or the supply of a service to be sold in the relevant market in quantities and at prices determined by an enterprise on the basis of the conditions of supply and demand, and which are undertaken with an orientation towards profit-making; activities undertaken by an enterprise which operates on a non-profit basis or a cost-recovery basis are not activities undertaken with an orientation towards profit-making; (c) "commercial considerations" means considerations of price, quality, availability, marketability, transportation and other terms and conditions of purchase or sale, or other factors that would normally be taken into account in the commercial decisions of a privately owned enterprise operating according to market economy principles in the relevant business or industry; (d) "covered entity" means: (i) a designated monopoly; (ii) an enterprise granted special rights or privileges; or (iii) a State-owned enterprise; (e) "designated monopoly" means an entity, including a consortium or a government agency, that, in a relevant market in the territory of a Party, is designated as the sole supplier or purchaser of a good or service, but does not include an entity that has been granted an exclusive intellectual property right solely by reason of such grant; in this context, designate means to establish or authorise a monopoly, or to expand the scope of a monopoly to cover an additional good or service; (f) "enterprise" means enterprise as defined in point (g) of Article 124; (g) "enterprise granted special rights or privileges" means any enterprise, public or private, to which a Party has granted special rights or privileges, in law or in fact; (h) "service supplied in the exercise of governmental authority" means a service supplied in the exercise of governmental authority as defined in GATS; (i) "special rights or privileges" means rights or privileges by which a Party designates or limits to two or more the number of enterprises authorised to supply a good or service, other than according to objective, proportional and non-discriminatory criteria, substantially affecting the ability of any other enterprise to supply the same good or service in the same geographical area or product market under substantially equivalent conditions; (j) "State-owned enterprise" means an enterprise in which a Party: (i) directly owns more than 50 % of the share capital; (ii) controls, directly or indirectly, the exercise of more than 50 % of the voting rights; (iii) holds the power to appoint a majority of the members of the board of directors or any other equivalent management body; or (iv) has the power to exercise control over the enterprise. For the establishment of control, all relevant legal and factual elements shall be taken into account on a case-by-case basis. Article 377 Scope 1. This Chapter applies to covered entities, at all levels of government, engaged in commercial activities. If a covered entity engages in both commercial and non-commercial activities, only the commercial activities are covered by this Chapter. 2. This Chapter does not apply to: (a) covered entities when acting as procuring entities, as defined in each Party's Annexes 1 to 3 to Appendix I to the GPA and paragraph 1 of each Party's respective subsections of Section B of Annex 25, conducting covered procurement as defined in Article 277(2); (b) any service supplied in the exercise of governmental authority. 3. This Chapter does not apply to a covered entity, if in any one of the three previous consecutive fiscal years the annual revenue derived from the commercial activities of the enterprise or monopoly concerned was less than 100 million Special Drawing Rights. 4. Article 380 does not apply to the supply of financial services by a covered entity pursuant to a government mandate, if that supply of financial services: (a) supports exports or imports, provided that those services are: (i) not intended to displace commercial financing; or (ii) offered on terms no more favourable than those that could be obtained for comparable financial services in the commercial market; or (b) supports private investment outside the territory of the Party, provided that those services are: (i) not intended to displace commercial financing; or (ii) offered on terms no more favourable than those that could be obtained for comparable financial services in the commercial market; or (c) is offered on terms consistent with the Arrangement, if the supply of those services falls within the scope of the Arrangement. 5. Without prejudice to paragraph 3 of this Article, Article 380 does not apply to the following sectors: audio-visual services; national maritime cabotage (60); and inland waterways transport, as set out in Article 123(5). 6. Article 380 does not apply to the extent that a covered entity of a Party makes purchases or sales of goods or services pursuant to: (a) any existing non-conforming measure that the Party maintains, continues, renews or amends in accordance with Article 133(1) or 139(1) as set out in its Schedules to Annexes 19 and 20, as applicable; or (b) any non-conforming measure that the Party adopts or maintains with respect to sectors, subsectors, or activities in accordance with Article 133(2) or 139(2) as set out in its Schedules to Annexes 19 and 20, as applicable. Article 378 Relationship with the WTO Agreement The Parties affirm their rights and obligations under paragraphs 1 to 3 of Article XVII of GATT 1994, the Understanding on the Interpretation of Article XVII of the GATT 1994, as well as under paragraphs 1, 2 and 5 of Article VIII of GATS. Article 379 General provisions 1. Without prejudice to the rights and obligations of each Party under this Chapter, nothing in this Chapter prevents a Party from establishing or maintaining a covered entity. 2. Neither Party shall require or encourage a covered entity to act in a manner inconsistent with this Chapter. Article 380 Non-discriminatory treatment and commercial considerations 1. Each Party shall ensure that each of its covered entities, when engaging in commercial activities: (a) acts in accordance with commercial considerations in its purchase or sale of a good or service, except to fulfil any terms of its public service mandate that are not inconsistent with point (b) or (c); (b) in its purchase of a good or service: (i) accords to a good or service supplied by an enterprise of the other Party treatment no less favourable than it accords to a like good or a like service supplied by enterprises of the Party; and (ii) accords to a good or service supplied by a covered entity in the Party's territory treatment no less favourable than it accords to a like good or a like service supplied by enterprises of the Party in the relevant market in the Party's territory; and (c) in its sale of a good or service: (i) accords to an enterprise of the other Party treatment no less favourable than it accords to enterprises of the Party; and (ii) accords to a covered entity in the Party's territory, treatment no less favourable than it accords to enterprises of the Party in the relevant market in the Party's territory. (61) 2. Points (b) and (c) of paragraph 1 do not preclude a covered entity from: (a) purchasing or supplying goods or services on different terms or conditions, including terms or conditions relating to price, provided that those different terms or conditions are in accordance with commercial considerations; or (b) refusing to purchase or supply goods or services, provided that such refusal is made in accordance with commercial considerations. Article 381 Regulatory framework 1. Each Party shall respect and make best use of relevant international standards including the OECD Guidelines on Corporate Governance of State-Owned Enterprises. 2. Each Party shall ensure that any regulatory body, and any other body exercising a regulatory function, that that Party establishes or maintains: (a) is independent from, and not accountable to, any of the enterprises regulated by that body; and (b) in like circumstances, acts impartially with respect to all enterprises regulated by that body, including covered entities; the impartiality with which the body exercises its regulatory functions is to be assessed by reference to a general pattern or practice of that body. For those sectors in which the Parties have agreed to specific obligations relating to such a body in this Agreement, the relevant provisions of this Agreement shall prevail. 3. Each Party shall apply its laws and regulations to covered entities in a consistent and non-discriminatory manner. Article 382 Information exchange 1. A Party which has reason to believe that its interests under this Chapter are being adversely affected by the commercial activities of an entity of the other Party may request the other Party in writing to provide information on the commercial activities of that entity related to the carrying out of the provisions of this Chapter in accordance with paragraph 2. 2. Provided that the request referred to in paragraph 1 includes an explanation of how the activities of the entity may be affecting the interests of the requesting Party under this Chapter and indicates which of the following categories of information is or are to be provided, the requested Party shall provide the information so requested: (a) the ownership and the voting structure of the entity, indicating the cumulative percentage of shares and the percentage of voting rights that the requested Party and its covered entities cumulatively have in the entity; (b) a description of any special shares or special voting or other rights that the requested Party or its covered entities hold, to the extent that such rights are different from those attached to the general common shares of the entity; (c) a description of the organisational structure of the entity and the composition of its board of directors or of any equivalent body; (d) a description of the government departments or public bodies which regulate or monitor the entity, a description of the reporting requirements imposed on it by those departments or public bodies, and the rights and practices of those departments or public bodies with respect to the appointment, dismissal or remuneration of senior executives and members of its board of directors or any equivalent body; (e) the annual revenue and total assets of the entity over the most recent three-year period for which information is available; (f) any exemptions, immunities and related measures from which the entity benefits under the laws and regulations of the requested Party; (g) any additional information regarding the entity that is publicly available, including annual financial reports and third-party audits. 3. Paragraphs 1 and 2 do not require a Party to disclose confidential information the disclosure of which would be inconsistent with its laws and regulations, would impede law enforcement, or otherwise would be contrary to the public interest or would prejudice the legitimate commercial interests of particular enterprises. 4. If the requested information is not available, the requested Party shall provide to the requesting Party, in writing, the reasons why that information is not available. CHAPTER 5 TAXATION Article 383 Good governance The Parties recognise and commit to implementing the principles of good governance in the area of taxation, in particular the global standards on tax transparency and exchange of information and fair tax competition. The Parties reiterate their support for the OECD Base Erosion and Profit Shifting (BEPS) Action Plan and affirm their commitment to implementing the OECD minimum standards against BEPS. The Parties will promote good governance in tax matters, improve international cooperation in the area of taxation and facilitate the collection of tax revenues. Article 384 Taxation standards 1. A Party shall not weaken or reduce the level of protection provided for in its legislation at the end of the transition period below the level provided for by the standards and rules which have been agreed in the OECD at the end of the transition period, in relation to: (a) the exchange of information, whether upon request, spontaneously or automatically, concerning financial accounts, cross-border tax rulings, country-by-country reports between tax administrations, and potential cross-border tax planning arrangements; (b) rules on interest limitation, controlled foreign companies and hybrid mismatches. 2. A Party shall not weaken or reduce the level of protection provided for in its legislation at the end of the transition period in respect of public country-by-country reporting by credit institutions and investment firms, other than small and non-interconnected investment firms. Article 385 Dispute settlement This Chapter shall not be subject to dispute settlement under Title I of Part Six. CHAPTER 6 LABOUR AND SOCIAL STANDARDS Article 386 Definition 1. For the purposes of this Chapter, "labour and social levels of protection" means the levels of protection provided overall in a Party's law and standards (62), in each of the following areas: (a) fundamental rights at work; (b) occupational health and safety standards; (c) fair working conditions and employment standards; (d) information and consultation rights at company level; or (e) restructuring of undertakings. 2. For the Union, "labour and social levels of protection" means labour and social levels of protection that are applicable to and in, and are common to, all Member States. Article 387 Non-regression from levels of protection 1. The Parties affirm the right of each Party to set its policies and priorities in the areas covered by this Chapter, to determine the labour and social levels of protection it deems appropriate and to adopt or modify its law and policies in a manner consistent with each Party's international commitments, including those under this Chapter. 2. A Party shall not weaken or reduce, in a manner affecting trade or investment between the Parties, its labour and social levels of protection below the levels in place at the end of the transition period, including by failing to effectively enforce its law and standards. 3. The Parties recognise that each Party retains the right to exercise reasonable discretion and to make bona fide decisions regarding the allocation of labour enforcement resources with respect to other labour law determined to have higher priority, provided that the exercise of that discretion, and those decisions, are not inconsistent with its obligations under this Chapter. 4. The Parties shall continue to strive to increase their respective labour and social levels of protection referred to in this Chapter. Article 388 Enforcement For the purposes of enforcement as referred to in Article 387 each Party shall have in place and maintain a system for effective domestic enforcement and, in particular, an effective system of labour inspections in accordance with its international commitments relating to working conditions and the protection of workers; ensure that administrative and judicial proceedings are available that allow public authorities and individuals with standing to bring timely actions against violations of the labour law and social standards; and provide for appropriate and effective remedies, including interim relief, as well as proportionate and dissuasive sanctions. In the domestic implementation and enforcement of Article 387, each Party shall respect the role and autonomy of the social partners at a national level, where relevant, in line with applicable law and practice. Article 389 Dispute settlement 1. The Parties shall make all efforts through dialogue, consultation, exchange of information and cooperation to address any disagreement on the application of this Chapter. 2. By way of derogation from Title I of Part Six, in the event of a dispute between the Parties regarding the application of this Chapter, the Parties shall have recourse exclusively to the procedures established under Articles 408, 409 and 410. CHAPTER 7 ENVIRONMENT AND CLIMATE Article 390 Definitions 1. For the purposes of this Chapter, "environmental levels of protection" means the levels of protection provided overall in a Party's law which have the purpose of protecting the environment, including the prevention of a danger to human life or health from environmental impacts, including in each of the following areas: (a) industrial emissions; (b) air emissions and air quality; (c) nature and biodiversity conservation; (d) waste management; (e) the protection and preservation of the aquatic environment; (f) the protection and preservation of the marine environment; (g) the prevention, reduction and elimination of risks to human health or the environment arising from the production, use, release or disposal of chemical substances; or (h) the management of impacts on the environment from agricultural or food production, notably through the use of antibiotics and decontaminants. 2. For the Union, "environmental levels of protection" means environmental levels of protection that are applicable to and in, and are common to, all Member States. 3. For the purposes of this Chapter, "climate level of protection" means the level of protection with respect to emissions and removals of greenhouse gases and the phase-out of ozone depleting substances. With regard to greenhouse gases, this means: (a) for the Union, the 40 % economy-wide 2030 target, including the Union's system of carbon pricing; (b) for the United Kingdom, the United Kingdom's economy-wide share of this 2030 target, including the United Kingdom's system of carbon pricing. Article 391 Non-regression from levels of protection 1. The Parties affirm the right of each Party to set its policies and priorities in the areas covered by this Chapter, to determine the environmental levels of protection and climate level of protection it deems appropriate and to adopt or modify its law and policies in a manner consistent with each Party's international commitments, including those under this Chapter. 2. A Party shall not weaken or reduce, in a manner affecting trade or investment between the Parties, its environmental levels of protection or its climate level of protection below the levels that are in place at the end of the transition period, including by failing to effectively enforce its environmental law or climate level of protection. 3. The Parties recognise that each Party retains the right to exercise reasonable discretion and to make bona fide decisions regarding the allocation of environmental enforcement resources with respect to other environmental law and climate policies determined to have higher priorities, provided that the exercise of that discretion, and those decisions, are not inconsistent with its obligations under this Chapter. 4. For the purposes of this Chapter, insofar as targets are provided for in a Party's environmental law in the areas listed in Article 390, they are included in a Party's environmental levels of protection at the end of the transition period. These targets include those whose attainment is envisaged for a date that is subsequent to the end of the transition period. This paragraph shall also apply to ozone depleting substances. 5. The Parties shall continue to strive to increase their respective environmental levels of protection or their respective climate level of protection referred to in this Chapter. Article 392 Carbon pricing 1. Each Party shall have in place an effective system of carbon pricing as of 1 January 2021. 2. Each system shall cover greenhouse gas emissions from electricity generation, heat generation, industry and aviation. 3. The effectiveness of the Parties' respective carbon pricing systems shall uphold the level of protection provided for by Article 391. 4. By way of derogation from paragraph 2, aviation shall be included within two years at the latest, if not included already. The scope of the Union system of carbon pricing shall cover departing flights from the European Economic Area to the United Kingdom. 5. Each Party shall maintain its system of carbon pricing insofar as it is an effective tool for each Party in the fight against climate change and shall in any event uphold the level of protection provided for by Article 391. 6. The Parties shall cooperate on carbon pricing. They shall give serious consideration to linking their respective carbon pricing systems in a way that preserves the integrity of these systems and provides for the possibility to increase their effectiveness. Article 393 Environmental and climate principles 1. Taking into account the fact that the Union and the United Kingdom share a common biosphere in respect of cross-border pollution, each Party commits to respecting the internationally recognised environmental principles to which it has committed, such as in the Rio Declaration on Environment and Development, adopted at Rio de Janeiro on 14 June 1992 (the "1992 Rio Declaration on Environment and Development") and in multilateral environmental agreements, including in the United Nations Framework Convention on Climate Change, done at New York on 9 May 1992 ("UNFCCC") and the Convention on Biological Diversity, done at Rio de Janeiro on 5 June 1992 (the "Convention on Biological Diversity"), in particular: (a) the principle that environmental protection should be integrated into the making of policies, including through impact assessments; (b) the principle of preventative action to avert environmental damage; (c) the precautionary approach referred to in Article 356(2); (d) the principle that environmental damage should as a priority be rectified at source; and (e) the polluter pays principle. 2. The Parties reaffirm their respective commitments to procedures for evaluating the likely impact of a proposed activity on the environment, and where specified projects, plans and programmes are likely to have significant environmental, including health, effects, this includes an environmental impact assessment or a strategic environmental assessment, as appropriate. 3. These procedures shall comprise, where appropriate and in accordance with a Party's laws, the determination of the scope of an environmental report and its preparation, the carrying out of public participation and consultations and the taking into account of the environmental report and the results of the public participation and consultations in the consented project, or adopted plan or programme. Article 394 Enforcement 1. For the purposes of enforcement as referred to in Article 391, each Party shall, in accordance with its law, ensure that: (a) domestic authorities competent to enforce the relevant law with regard to environment and climate give due consideration to alleged violations of such law that come to their attention; those authorities shall have adequate and effective remedies available to them, including injunctive relief as well as proportionate and dissuasive sanctions, if appropriate; and (b) national administrative or judicial proceedings are available to natural and legal persons with a sufficient interest to bring actions against violations of such law and to seek effective remedies, including injunctive relief, and that the proceedings are not prohibitively costly and are conducted in a fair, equitable and transparent way. Article 395 Cooperation on monitoring and enforcement The Parties shall ensure that the European Commission and the supervisory bodies of the United Kingdom regularly meet with each other and co-operate on the effective monitoring and enforcement of the law with regard to environment and climate as referred to in Article 391. Article 396 Dispute settlement 1. The Parties shall make all efforts through dialogue, consultation, exchange of information and cooperation to address any disagreement on the application of this Chapter. 2. By way of derogation from Title I of Part Six, in the event of a dispute between the Parties regarding the application of this Chapter, the Parties shall have recourse exclusively to the procedures established under Articles 408, 409 and 410. CHAPTER 8 OTHER INSTRUMENTS FOR TRADE AND SUSTAINABLE DEVELOPMENT Article 397 Context and objectives 1. The Parties recall the Agenda 21 and the 1992 Rio Declaration on Environment and Development, the Johannesburg Plan of Implementation of the World Summit on Sustainable Development of 2002, the International Labour Organization (ILO) Declaration on Social Justice for a Fair Globalization, adopted at Geneva on 10 June 2008 by the International Labour Conference at its 97th Session (the "2008 ILO Declaration on Social Justice for a Fair Globalization"), the Outcome Document of the UN Conference on Sustainable Development of 2012 entitled "The Future We Want", endorsed by the UN General Assembly Resolution 66/288 adopted on 27 July 2012, and the UN 2030 Agenda for Sustainable Development, adopted by the UN General Assembly Resolution 70/1 on 25 September 2015 and its Sustainable Development Goals. 2. In light of paragraph 1 of this Article, the objective of this Chapter is to enhance the integration of sustainable development, notably its labour and environmental dimensions, in the Parties' trade and investment relationship and in this respect to complement the commitments of the Parties under Chapters 6 and 7. Article 398 Transparency 1. The Parties stress the importance of ensuring transparency as a necessary element to promote public participation and of making information public within the context of this Chapter. In accordance with their laws and regulations, the provisions of this Chapter, of Title IX and of Title X, each Party shall: (a) ensure that any measure of general application pursuing the objectives of this Chapter is administered in a transparent manner, including by providing the public with reasonable opportunities and sufficient time to comment, and by publishing such measures; (b) ensure that the general public is given access to relevant environmental information held by or for public authorities, as well as ensuring the active dissemination of that information to the general public by electronic means; (c) encourage public debate with and among non-state actors as regards the development and definition of policies that may lead to the adoption of law relevant to this Chapter by its public authorities; this includes, in relation to the environment, public participation in projects, plans and programmes; and (d) promote public awareness of its laws and standards relevant to this Chapter, as well as enforcement and compliance procedures, by taking steps to further the knowledge and understanding of the public; in relation to labour laws and standards, this includes workers, employers and their representatives. Article 399 Multilateral labour standards and agreements 1. The Parties affirm their commitment to promoting the development of international trade in a way that is conducive to decent work for all, as expressed in the 2008 ILO Declaration on Social Justice for a Fair Globalization. 2. In accordance with the ILO Constitution and the ILO Declaration on Fundamental Principles and Rights at Work and its Follow-up, adopted at Geneva on 18 June 1998 by the International Labour Conference at its 86th Session, each Party commits to respecting, promoting and effectively implementing the internationally recognised core labour standards, as defined in the fundamental ILO Conventions, which are: (a) freedom of association and the effective recognition of the right to collective bargaining; (b) the elimination of all forms of forced or compulsory labour; (c) the effective abolition of child labour; and (d) the elimination of discrimination in respect of employment and occupation. 3. Each Party shall make continued and sustained efforts to ratify the fundamental ILO Conventions if they have not yet done so. 4. The Parties shall exchange information, regularly and as appropriate, on the respective situations and progress of the Member States and of the United Kingdom with regard to the ratification of ILO Conventions or protocols classified as up-to-date by the ILO and of other relevant international instruments. 5. Each Party commits to implementing all the ILO Conventions that the United Kingdom and the Member States have respectively ratified and the different provisions of the European Social Charter that, as members of the Council of Europe, the Member States and the United Kingdom have respectively accepted (63). 6. Each Party shall continue to promote, through its laws and practices, the ILO Decent Work Agenda as set out in the 2008 ILO Declaration on Social Justice for a Fair Globalization (the "ILO Decent Work Agenda") and in accordance with relevant ILO Conventions, and other international commitments, in particular with regard to: (a) decent working conditions for all, with regard to, inter alia, wages and earnings, working hours, maternity leave and other conditions of work; (b) health and safety at work, including the prevention of occupational injury or illness and compensation in cases of such injury or illness; and (c) non-discrimination in respect of working conditions, including for migrant workers. 7. Each Party shall protect and promote social dialogue on labour matters among workers and employers, and their respective organisations, and with relevant government authorities. 8. The Parties shall work together on trade-related aspects of labour policies and measures, including in multilateral fora, such as the ILO, as appropriate. Such cooperation may cover inter alia: (a) trade-related aspects of implementation of fundamental, priority and other up-to-date ILO Conventions; (b) trade-related aspects of the ILO Decent Work Agenda, including on the interlinkages between trade and full and productive employment, labour market adjustment, core labour standards, decent work in global supply chains, social protection and social inclusion, social dialogue and gender equality; (c) the impact of labour law and standards on trade and investment, or the impact of trade and investment law on labour; (d) dialogue and information-sharing on the labour provisions in the context of their respective trade agreements, and the implementation thereof; and (e) any other form of cooperation deemed appropriate. 9. The Parties shall consider any views provided by representatives of workers, employers, and civil society organisations when identifying areas of cooperation and when carrying out cooperative activities. Article 400 Multilateral environmental agreements 1. The Parties recognise the importance of the UN Environment Assembly of the UN Environment Programme and of multilateral environmental governance and agreements as a response of the international community to global or regional environmental challenges and stress the need to enhance the mutual supportiveness between trade and environment policies, rules and measures. 2. In light of paragraph 1, each Party commits to effectively implementing the multilateral environmental agreements, protocols and amendments that it has ratified in its law and practices. 3. The Parties shall regularly and as appropriate exchange information on: (a) their respective situations as regards the ratification and implementation of multilateral environmental agreements, including their protocols and amendments; (b) on-going negotiations of new multilateral environmental agreements; and (c) each Party's respective views on becoming a party to additional multilateral environmental agreements. 4. The Parties reaffirm the right of each Party to adopt or maintain measures to further the objectives of multilateral environmental agreements to which it is party. The Parties recall that measures adopted or enforced to implement such multilateral environmental agreements may be justified under Article 412. 5. The Parties shall work together on trade-related aspects of environmental policies and measures, including in multilateral fora, such as the UN High-level Political Forum for Sustainable Development, the UN Environment Programme, the UN Environment Assembly, multilateral environmental agreements, the International Civil Aviation Organization (ICAO) or the WTO as appropriate. Such cooperation may cover inter alia: (a) initiatives on sustainable production and consumption, including those aimed at promoting a circular economy and green growth and pollution abatement; (b) initiatives to promote environmental goods and services, including by addressing related tariff and non-tariff barriers; (c) the impact of environmental law and standards on trade and investment; or the impact of trade and investment law on the environment; (d) the implementation of Annex 16 to the Convention on International Civil Aviation, done at Chicago on 7 December 1944, and other measures to reduce the environmental impact of aviation, including in the area of air traffic management; and (e) other trade-related aspects of multilateral environmental agreements, including their protocols, amendments and implementation. 6. Cooperation pursuant to paragraph 5 may include technical exchanges, exchanges of information and best practices, research projects, studies, reports, conferences and workshops. 7. The Parties will consider views or input from the public and interested stakeholders for the definition and implementation of their cooperation activities, and they may involve such stakeholders further in those activities, as appropriate. Article 401 Trade and climate change 1. The Parties recognise the importance of taking urgent action to combat climate change and its impacts, and the role of trade and investment in pursuing that objective, in line with the UNFCCC, with the purpose and goals of the Paris Agreement adopted at Paris on 12 December 2015 by the Conference of the Parties to the United Nations Framework Convention on Climate Change at its 21st session (the "Paris Agreement"), and with other multilateral environmental agreements and multilateral instruments in the area of climate change. 2. In light of paragraph 1, each Party: (a) commits to effectively implementing the UNFCCC, and the Paris Agreement of which one principal aim is strengthening the global response to climate change and holding the increase in the global average temperature to well below 2 oC above pre-industrial levels and pursuing efforts to limit the temperature increase to 1,5 oC above pre-industrial levels; (b) shall promote the mutual supportiveness of trade and climate policies and measures thereby contributing to the transition to a low greenhouse gas emission, resource-efficient economy and to climate-resilient development; and (c) shall facilitate the removal of obstacles to trade and investment in goods and services of particular relevance for climate change mitigation and adaptation, such as renewable energy, energy efficient products and services, for instance through addressing tariff and non-tariff barriers or through the adoption of policy frameworks conducive to the deployment of the best available solutions. 3. The Parties shall work together to strengthen their cooperation on trade-related aspects of climate change policies and measures bilaterally, regionally and in international fora, as appropriate, including in the UNFCCC, the WTO, the Montreal Protocol on Substances that Deplete the Ozone Layer done at Montreal on 26 August 1987 (the "Montreal Protocol"), the International Maritime Organisation (IMO) and the ICAO. Such cooperation may cover inter alia: (a) policy dialogue and cooperation regarding the implementation of the Paris Agreement, such as on means to promote climate resilience, renewable energy, low-carbon technologies, energy efficiency, sustainable transport, sustainable and climate-resilient infrastructure development, emissions monitoring, international carbon markets; (b) supporting the development and adoption of ambitious and effective greenhouse gas emissions reduction measures by the IMO to be implemented by ships engaged in international trade; (c) supporting the development and adoption of ambitious and effective greenhouse gas emissions reduction measures by the ICAO; and (d) supporting an ambitious phase-out of ozone depleting substances and phase-down of hydrofluorocarbons under the Montreal Protocol through measures to control their production, consumption and trade; the introduction of environmentally friendly alternatives to them; the updating of safety and other relevant standards as well as through combating the illegal trade of substances regulated by the Montreal Protocol. Article 402 Trade and biological diversity 1. The Parties recognise the importance of conserving and sustainably using biological diversity and the role of trade in pursuing these objectives, including by promoting sustainable trade or controlling or restricting trade in endangered species, in line with the relevant multilateral environmental agreements to which they are party, and the decisions adopted thereunder, notably the Convention on Biological Diversity and its protocols, and the Convention on International Trade in Endangered Species of Wild Fauna and Flora, done at Washington D.C. on 3 March 1973 ("CITES"). 2. In light of paragraph 1, each Party shall: (a) implement effective measures to combat illegal wildlife trade, including with respect to third countries, as appropriate; (b) promote the use of CITES as an instrument for conservation and sustainable management of biodiversity, including through the inclusion of animal and plant species in the Appendices to CITES where the conservation status of that species is considered at risk because of international trade; (c) encourage trade in products derived from a sustainable use of biological resources and contributing to the conservation of biodiversity; and (d) continue to take measures to conserve biological diversity when it is subject to pressures linked to trade and investment, in particular through measures to prevent the spread of invasive alien species. 3. The Parties shall work together on trade-related matters of relevance to this Article, including in multilateral fora, such as CITES and the Convention on Biological Diversity, as appropriate. Such cooperation may cover inter alia: trade in wildlife and natural resource-based products, the valuation and assessment of ecosystems and related services, and the access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation consistent with the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity, done at Nagoya on 29 October 2010. Article 403 Trade and forests 1. The Parties recognise the importance of conservation and sustainable forest management for providing environmental functions and economic and social opportunities for present and future generations, and the role of trade in pursuing that objective. 2. In light of paragraph 1 and in a manner consistent with its international obligations, each Party shall: (a) continue to implement measures to combat illegal logging and related trade, including with respect to third countries, as appropriate, and to promote trade in legally harvested forest products; (b) promote the conservation and sustainable management of forests and trade and consumption of timber and timber products harvested in accordance with the law of the country of harvest and from sustainably managed forests; and (c) exchange information with the other Party on trade-related initiatives on sustainable forest management, forest governance and on the conservation of forest cover and cooperate to maximise the impact and mutual supportiveness of their respective policies of mutual interest. 3. The Parties shall work together to strengthen their cooperation on trade-related aspects of sustainable forest management, the conservation of forest cover and illegal logging, including in multilateral fora, as appropriate. Article 404 Trade and sustainable management of marine biological resources and aquaculture 1. The Parties recognise the importance of conserving and sustainably managing marine biological resources and ecosystems as well as of promoting responsible and sustainable aquaculture, and the role of trade in pursuing those objectives. 2. In light of paragraph 1, each Party: (a) commits to acting consistently and complying, as appropriate, with the relevant UN and Food and Agriculture Organization ("FAO") agreements, the United Nations Convention on the Law of the Sea, the Agreement for the Implementation of the Provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks, done at New York on 4 August 1995, the FAO Agreement to Promote Compliance with International Conservation and Management Measures by Fishing Vessels on the High Seas, done at Rome on 24 November 1993, the FAO Code of Conduct for Responsible Fisheries and the FAO Agreement on Port State Measures to Prevent, Deter and Eliminate Illegal, Unreported and Unregulated ("IUU") fishing, approved at Rome on 22 November 2009 at the 36th Session of the FAO Conference, and to participating in the FAO's initiative on the Global Record of Fishing Vessels, Refrigerated Transport Vessels and Supply Vessels; (b) shall promote sustainable fisheries and good fisheries governance by participating actively in the work of relevant international organisations or bodies to which they are members, observers, or cooperating non-contracting parties, including the Regional Fisheries Management Organizations (RFMOs) by means of, where applicable, effective monitoring, control or enforcement of the RFMOs' resolutions, recommendations or measures; the implementation of their catch documentation or certification schemes, and port state measures; (c) shall adopt and maintain their respective effective tools to combat IUU fishing, including measures to exclude the products of IUU fishing from trade flows, and cooperate to that end; and (d) shall promote the development of sustainable and responsible aquaculture, including with regard to the implementation of the objectives and principles contained in the FAO Code of Conduct for Responsible Fisheries, as appropriate. 3. The Parties shall work together on conservation and trade-related aspects of fishery and aquaculture policies and measures, including in the WTO, the RFMOs and other multilateral fora, as appropriate, with the aim of promoting sustainable fishing and aquaculture practices and trade in fish products from sustainably managed fisheries and aquaculture operations. 4. This Article is without prejudice to the provisions of Heading Five. Article 405 Trade and investment favouring sustainable development 1. The Parties confirm their commitment to enhancing the contribution of trade and investment to the goal of sustainable development in its economic, social and environmental dimensions. 2. Pursuant to paragraph 1, the Parties shall continue to promote: (a) trade and investment policies that support the four strategic objectives of the ILO Decent Work Agenda, consistent with the 2008 ILO Declaration on Social Justice for a Fair Globalization, including the minimum living wage, health and safety at work, and other aspects related to working conditions; (b) trade and investment in environmental goods and services, such as renewable energy and energy efficient products and services, including through addressing related non-tariff barriers or through the adoption of policy frameworks conducive to the deployment of the best available solutions; (c) trade in goods and services that contribute to enhanced social conditions and environmentally sound practices, including those subject to voluntary sustainability assurance schemes such as fair and ethical trade schemes and eco-labels; and (d) cooperation in multilateral fora on issues referred to in this Article. 3. The Parties recognise the importance of addressing specific sustainable development issues by reviewing, monitoring and assessing the potential economic, social and environmental impacts of possible actions, taking account of the views of stakeholders. Article 406 Trade and responsible supply chain management 1. The Parties recognise the importance of responsible management of supply chains through responsible business conduct and corporate social responsibility practices and the role of trade in pursuing this objective. 2. In light of paragraph 1, each Party shall: (a) encourage corporate social responsibility and responsible business conduct, including by providing supportive policy frameworks that encourage the uptake of relevant practices by businesses; and (b) support the adherence, implementation, follow-up and dissemination of relevant international instruments, such as the OECD Guidelines for Multinational Enterprises, the ILO Tripartite Declaration of Principles concerning Multinational Enterprises and Social Policy, the UN Global Compact, and the UN Guiding Principles on Business and Human Rights. 3. The Parties recognise the utility of international sector-specific guidelines in the area of corporate social responsibility and responsible business conduct and shall encourage joint work in this regard. In respect of the OECD Due Diligence Guidance for responsible supply chains of minerals from conflict-affected and high-risk areas and its supplements, the Parties shall also implement measures to promote the uptake of that Guidance. 4. The Parties shall work together to strengthen their cooperation on trade-related aspects of issues covered by this Article, including in multilateral fora, as appropriate, inter alia through the exchange of information, best practices and outreach initiatives. Article 407 Dispute settlement 1. The Parties shall make all efforts through dialogue, consultation, exchange of information and cooperation to address any disagreement on the application of this Chapter. 2. By way of derogation from Title I of Part Six, in the event of a dispute between the Parties regarding the application of this Chapter, the Parties shall have recourse exclusively to the procedures established under Articles 408 and 409. CHAPTER 9 HORIZONTAL AND INSTITUTIONAL PROVISIONS Article 408 Consultations 1. A Party may request consultations with the other Party regarding any matter arising under Article 355(3) and Chapters 6, 7, and 8 by delivering a written request to the other Party. The complaining Party shall specify in its written request the reasons and basis for the request, including identification of the measures at issue, specifying the provisions that it considers applicable. Consultations must commence promptly after a Party delivers a request for consultations and in any event not later than 30 days after the date of delivery of the request, unless the Parties agree to a longer period. 2. The Parties shall enter into consultations with the aim of reaching a mutually satisfactory resolution of the matter. During consultations, each Party shall provide the other Party with sufficient information in its possession to allow a full examination of the matters raised. Each Party shall endeavour to ensure the participation of personnel of their competent authorities who have expertise in the matter subject to the consultations. 3. In matters relating to Article 355(3) or to the multilateral agreements or instruments referred to in Chapters 6, 7 or 8 the Parties shall take into account available information from the ILO or relevant bodies or organisations established under multilateral environmental agreements. Where relevant, the Parties shall jointly seek advice from such organisations or their bodies, or any other expert or body they deem appropriate. 4. Each Party may seek, when appropriate, the views of the domestic advisory groups referred to in Article 13 or other expert advice. 5. Any resolution reached by the Parties shall be made available to the public. Article 409 Panel of experts 1. For any matter that is not satisfactorily addressed through consultations under Article 408, a Party may, after 90 days from the receipt of a request for consultations under that Article, request that a panel of experts be convened to examine that matter, by delivering a written request to the other Party. The request shall identify the measure at issue, specify and explain how that measure does not conform with the provisions of the relevant Chapter or Chapters in a manner sufficient to present the complaint clearly. 2. The panel of experts shall be composed of three panellists. 3. The Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development shall, at its first meeting after the entry into force of this Agreement, establish a list of at least 15 individuals who are willing and able to serve as panellists. Each Party shall name at least five individuals to the list to serve as panellists. The Parties shall also name at least five individuals who are not nationals of either Party and who are willing and able to serve as chairperson of a panel of experts. The Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development shall ensure that the list is kept up to date and that the number of experts is maintained at a minimum of 15 individuals. 4. The experts proposed as panellists must have specialised knowledge or expertise in labour or environmental law, other issues addressed in the relevant Chapter or Chapters, or in the resolution of disputes arising under international agreements. They must serve in their individual capacities and not take instructions from any organisation or government with regard to matters related to the dispute. They must not be affiliated with or take instructions from either Party. They shall not be persons who are members, officials or other servants of the Union institutions, of the Government of a Member State, or of the Government of the United Kingdom. 5. Unless the Parties agree otherwise within five days from the date of establishment of the panel of experts, the terms of reference shall be: "to examine, in the light of the relevant provisions, the matter referred to in the request for the establishment of the panel of experts, and to deliver a report in accordance with this Article that makes findings on the conformity of the measure with the relevant provisions". 6. In respect of matters related to multilateral standards or agreements covered in this Title, the panel of experts should seek information from the ILO or relevant bodies established under those agreements, including any pertinent available interpretative guidance, findings or decisions adopted by the ILO and those bodies. 7. The panel of experts may request and receive written submissions or any other information from persons with relevant information or specialised knowledge. 8. The panel of experts shall make available such information to each Party, allowing them to submit their comments within 20 days of its receipt. 9. The panel of experts shall issue to the Parties an interim report and a final report setting out the findings of fact, its determinations on the matter including as to whether the respondent Party has conformed with its obligations under the relevant Chapter or Chapters and the rationale behind any findings and determinations that it makes. For greater certainty, the Parties share the understanding that if the Panel makes recommendations in its report, the respondent Party does not need to follow these recommendations in ensuring conformity with this Agreement. 10. The panel of experts shall deliver to the Parties the interim report within 100 days after the date of establishment of the panel of experts. When the panel of experts considers that this deadline cannot be met, the chairperson of the panel of experts shall notify the Parties in writing, stating the reasons for the delay and the date on which the panel of experts plans to deliver its interim report. The panel of experts shall, under no circumstances, deliver its interim report later than 125 days after the date of establishment of the panel of experts. 11. Each Party may deliver to the panel of experts a reasoned request to review particular aspects of the interim report within 25 days of its delivery. A Party may comment on the other Party's request within 15 days of the delivery of the request. 12. After considering those comments, the panel of experts shall prepare the final report. If no request to review particular aspects of the interim report are delivered within the time period referred to in paragraph 11, the interim report shall become the final report of the panel of experts. 13. The panel of experts shall deliver its final report to the Parties within 175 days of the date of establishment of the panel of experts. When the panel of experts considers that this time limit cannot be met, its chairperson shall notify the Parties in writing, stating the reasons for the delay and the date on which the panel of experts plans to deliver its final report. The panel of experts shall, under no circumstances, deliver its final report later than 195 days after the date of establishment of the panel of experts. 14. The final report shall include a discussion of any written request by the Parties on the interim report and clearly address the comments of the Parties. 15. The Parties shall make the final report available to the public within 15 days of its delivery by the panel of experts. 16. If the final report of the panel of experts determines that a Party has not conformed with its obligations under the relevant Chapter or Chapters, the Parties shall, within 90 days of the delivery of the final report, discuss appropriate measures to be implemented taking into account the report of the panel of experts. No later than 105 days after the report has been delivered to the Parties, the respondent Party shall inform its domestic advisory groups established under Article 13 and the complaining Party of its decision on any measures to be implemented. 17. The Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development shall monitor the follow-up to the report of the panel of experts. The domestic advisory groups of the Parties established under Article 13 may submit observations to the Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development in that regard. 18. When the Parties disagree on the existence of, or the consistency with, the relevant provisions of any measure taken to address the non-conformity, the complaining Party may deliver a request, which shall be in writing, to the original panel of experts to decide on the matter. The request shall identify any measure at issue and explain how that measure is not in conformity with the relevant provisions in a manner sufficient to present the complaint clearly. The panel of experts shall deliver its findings to the Parties within 45 days of the date of the delivery of the request. 19. Except as otherwise provided for in this Article, Article 739(1), Article 740 and Articles 753 to 758, as well as Annexes 48 and 49, shall apply mutatis mutandis. Article 410 Panel of experts for non-regression areas 1. Article 409 shall apply to disputes between the Parties concerning the interpretation and application of Chapters 6 and 7. 2. For the purposes of such disputes, in addition to the Articles listed in Article 409(19), Articles 749 and 750 shall apply mutatis mutandis. 3. The Parties recognise that, where the respondent Party chooses not take any action to conform with the report of the panel of experts and with this Agreement, any remedies authorised under Article 749 continue to be available to the complaining Party. Article 411 Rebalancing 1. The Parties recognise the right of each Party to determine its future policies and priorities with respect to labour and social, environmental or climate protection, or with respect to subsidy control, in a manner consistent with each Party's international commitments, including those under this Agreement. At the same time, the Parties acknowledge that significant divergences in these areas can be capable of impacting trade or investment between the Parties in a manner that changes the circumstances that have formed the basis for the conclusion of this Agreement. 2. If material impacts on trade or investment between the Parties are arising as a result of significant divergences between the Parties in the areas referred to in paragraph 1, either Party may take appropriate rebalancing measures to address the situation. Such measures shall be restricted with respect to their scope and duration to what is strictly necessary and proportionate in order to remedy the situation. Priority shall be given to such measures as will least disturb the functioning of this Agreement. A Party's assessment of those impacts shall be based on reliable evidence and not merely on conjecture or remote possibility. 3. The following procedures shall apply to rebalancing measures taken under paragraph 2: (a) the concerned Party shall, without delay, notify the other Party through the Partnership Council of the rebalancing measures it intends to take, providing all relevant information. The Parties shall immediately enter into consultations. Consultations shall be deemed concluded within 14 days from the date of delivery of the notification, unless they are jointly concluded before that time limit; (b) if no mutually acceptable solution is found, the concerned Party may adopt rebalancing measures no sooner than five days from the conclusion of the consultations, unless the notified Party requests within the same five day period, in accordance with Article 739(2) (64), the establishment of an arbitration tribunal by means of a written request delivered to the other Party in order for the arbitration tribunal to decide whether the notified rebalancing measures are consistent with paragraph 2 of this Article; (c) the arbitration tribunal shall conduct its proceeding in accordance with Article 760 and deliver its final ruling within 30 days from its establishment. If the arbitration tribunal does not deliver its final ruling within that time period, the concerned Party may adopt the rebalancing measures no sooner than three days after the expiry of that 30 day time period. In that case, the other Party may take countermeasures proportionate to the adopted rebalancing measures until the arbitration tribunal delivers its ruling. Priority shall be given to such countermeasures as will least disturb the functioning of this Agreement. Point (a) shall apply mutatis mutandis to such countermeasures, which may be adopted no sooner than three days after the conclusion of consultations; (d) if the arbitration tribunal has found the rebalancing measures to be consistent with paragraph 2, the concerned Party may adopt the rebalancing measures as notified to the other Party; (e) if the arbitration tribunal has found the rebalancing measures to be inconsistent with paragraph 2 of this Article, the concerned Party shall, within three days from the delivery of the ruling, notify the complaining Party of the measures (65) it intends to adopt to comply with the ruling of the arbitration tribunal. Article 748(2) and Articles 749 (66) and 750 shall apply mutatis mutandis, if the complaining Party considers that the notified measures are not in compliance with the ruling of the arbitration tribunal. The procedures under Article 748(2) and Articles 749 and 750 shall have no suspensive effect on the application of the notified measures pursuant to this paragraph; (f) if rebalancing measures were adopted prior to the arbitration ruling in accordance with point (c), any countermeasures adopted pursuant to that point shall be withdrawn immediately, and in no case later than five days, after delivery of the ruling of the arbitration tribunal; (g) a Party shall not invoke the WTO Agreement or any other international agreement to preclude the other Party from taking measures pursuant to paragraphs 2 and 3, including when those measures consist of suspension of obligations under this Agreement; (h) if the notified Party does not submit a request pursuant to point (b) of this paragraph within the time period laid down therein, that Party may without having prior recourse to consultations in accordance with Article 738 initiate the arbitration procedure referred to in Article 739. An arbitration tribunal shall treat the issue as a case of urgency for the purposes of Article 744. 4. In order to ensure an appropriate balance between the commitments made by the Parties in this Agreement on a more durable basis, either Party may request, no sooner than four years after the entry into force of this Agreement, a review of the operation of this Heading. The Parties may agree that other Headings of this Agreement may be added to the review. 5. Such a review shall commence at a Party's request, if that Party considers that measures under paragraph 2 or 3 have been taken frequently by either or both Parties, or if a measure that has a material impact on trade or investment between the Parties has been applied for a period of 12 months. For the purposes of this paragraph, the measures in question are those which were not challenged or not found by an arbitration tribunal to be strictly unnecessary pursuant to point (d) or (h) of paragraph 3. This review may commence earlier than four years after the entry into force of this Agreement. 6. The review requested pursuant to paragraph 4 or 5 shall begin within three months of the request and be completed within six months. 7. A review on the basis of paragraph 4 or 5 may be repeated at subsequent intervals of no less than four years after the conclusion of the previous review. If a Party has requested a review under paragraph 4 or 5, it may not request a further review under either paragraph 4 or 5 for at least four years from the conclusion of the previous review or, if applicable, from the entry into force of any amending agreement. 8. The review shall address whether this Agreement delivers an appropriate balance of rights and obligations between the Parties, in particular with regard to the operation of this Heading, and whether, as a result, there is a need for any modification of the terms of this Agreement. 9. The Partnership Council may decide that no action is required as a result of the review. If a Party considers that following the review there is a need for an amendment of this Agreement, the Parties shall use their best endeavours to negotiate and conclude an agreement making the necessary amendments. Such negotiations shall be limited to matters identified in the review. 10. If an amending agreement referred to in paragraph 9 is not concluded within one year from the date the Parties started negotiations, either Party may give notice to terminate this Heading or any other Heading of this Agreement that was added to the review, or the Parties may decide to continue negotiations. If a Party terminates this Heading, Heading Three shall be terminated on the same date. The termination shall take effect three months after the date of such notice. 11. If this Heading is terminated pursuant to paragraph 10 of this Article, Heading Two shall be terminated on the same date, unless the Parties agree to integrate the relevant parts of Title XI of this Heading in Heading Two. 12. Title I of Part Six does not apply to paragraphs 4 to 9 of this Article. TITLE XII EXCEPTIONS Article 412 General exceptions 1. Nothing in Chapter 1 and Chapter 5 of Title I, Chapter 2 of Title II, Title III, Title VIII and Chapter 4 of Title XI shall be construed as preventing a Party from adopting or maintaining measures compatible with Article XX of GATT 1994. To that end, Article XX of GATT 1994, including its Notes and Supplementary Provisions, is incorporated into and made part of this Agreement, mutatis mutandis. 2. Subject to the requirement that such measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where like conditions prevail, or a disguised restriction on investment liberalisation or trade in services, nothing in Title II, Title III, Title IV, Title VIII and Chapter 4 of Title XI shall be construed to prevent the adoption or enforcement by either Party of measures: (a) necessary to protect public security or public morals or to maintain public order (67); (b) necessary to protect human, animal or plant life or health; (c) necessary to secure compliance with laws or regulations which are not inconsistent with the provisions of this Agreement including those relating to: (i) the prevention of deceptive and fraudulent practices or to deal with the effects of a default on contracts; (ii) the protection of the privacy of individuals in relation to the processing and dissemination of personal data and the protection of confidentiality of individual records and accounts; and (iii) safety. 3. For greater certainty, the Parties understand that, to the extent that such measures are otherwise inconsistent with the provisions of the chapters or titles referred to in paragraphs 1 and 2 of this Article: (a) the measures referred to in point (b) of Article XX of GATT 1994 and in point (b) of paragraph 2 of this Article include environmental measures, which are necessary to protect human, animal or plant life and health; (b) point (g) of Article XX of GATT 1994 applies to measures relating to the conservation of living and non-living exhaustible natural resources; and (c) measures taken to implement multilateral environmental agreements can fall under points (b) or (g) of Article XX of GATT 1994 or under point (b) of paragraph 2 of this Article. 4. Before a Party takes any measures provided for in points (i) and (j) of Article XX of GATT 1994, that Party shall provide the other Party with all relevant information, with a view to seeking a solution acceptable to the Parties. If no agreement is reached within 30 days of providing the information, the Party may apply the relevant measures. Where exceptional and critical circumstances requiring immediate action make prior information or examination impossible, the Party intending to take the measures may apply forthwith precautionary measures necessary to deal with the situation. That Party shall inform the other Party immediately thereof. Article 413 Taxation 1. Nothing in Titles I to VII, Chapter 4 of Title VIII, Titles IX to XII of this Heading or Heading Six shall affect the rights and obligations of either the Union or its Member States and the United Kingdom, under any tax convention. In the event of any inconsistency between this Agreement and any such tax convention, the tax convention shall prevail to the extent of the inconsistency. With regard to a tax convention between the Union or its Member States and the United Kingdom, the relevant competent authorities under this Agreement and that tax convention shall jointly determine whether an inconsistency exists between this Agreement and the tax convention. (68) 2. Articles 130 and 138 shall not apply to an advantage accorded pursuant to a tax convention. 3. Subject to the requirement that tax measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where like conditions prevail, or a disguised restriction on trade and investment, nothing in Titles I to VII, Chapter 4 of Title VIII, Titles IX to XII of this Heading or Heading Six shall be construed to prevent the adoption, maintenance or enforcement by a Party of any measure that: (a) aims at ensuring the equitable or effective (69) imposition or collection of direct taxes; or (b) distinguishes between taxpayers, who are not in the same situation, in particular with regard to their place of residence or with regard to the place where their capital is invested. 4. For the purposes of this Article, the following definitions apply: (a) "residence" means residence for tax purposes; (b) "tax convention" means a convention for the avoidance of double taxation or any other international agreement or arrangement relating wholly or mainly to taxation; and (c) "direct taxes" comprise all taxes on income or capital, including taxes on gains from the alienation of property, taxes on estates, inheritances and gifts, taxes on wages or salaries paid by enterprises and taxes on capital appreciation. Article 414 WTO Waivers If an obligation in Titles I to XII of this Heading or Heading Six of this Part is substantially equivalent to an obligation contained in the WTO Agreement, any measure taken in conformity with a waiver adopted pursuant to Article IX of the WTO Agreement is deemed to be in conformity with the substantially equivalent provision in this Agreement. Article 415 Security exceptions Nothing in Titles I to XII of this Heading or Heading Six shall be construed: (a) to require a Party to furnish or allow access to any information the disclosure of which it considers contrary to its essential security interests; or (b) to prevent a Party from taking an action which it considers necessary for the protection of its essential security interests: (i) connected to the production of or traffic in arms, ammunition and implements of war and to such production, traffic and transactions in other goods and materials, services and technology, and to economic activities, carried out directly or indirectly for the purpose of supplying a military establishment; (ii) relating to fissionable and fusionable materials or the materials from which they are derived; or (iii) in time of war or other emergency in international relations; or (c) to prevent a Party from taking any action in pursuance of its obligations under the United Nations Charter for the maintenance of international peace and security. Article 416 Confidential information 1. With the exception of Article 384, nothing in Titles I to XII of this Heading or Heading Six of this Part shall be construed as requiring a Party to make available confidential information, the disclosure of which would impede law enforcement, or otherwise be contrary to the public interest, or which would prejudice the legitimate commercial interests of particular enterprises, public or private, except where an arbitration tribunal requires such confidential information in dispute settlement proceedings under Title I of Part Six, or where a panel of experts requires such confidential information in proceedings under Article 409 or 410. In such cases, the arbitration tribunal, or, as the case may be, the panel of experts shall ensure that confidentiality is fully protected in accordance with Annex 48. 2. When a Party submits information to the Partnership Council or to Committees that is considered as confidential under its laws and regulations, the other Party shall treat that information as confidential, unless the submitting Party agrees otherwise. HEADING TWO AVIATION TITLE I AIR TRANSPORT Article 417 Definitions For the purposes of this Title, the following definitions apply: (a) "air carrier" means an air transport undertaking holding a valid operating licence or equivalent; (b) "air carrier of the Union" means an air carrier that fulfils the conditions laid down in point (b) of Article 422(1); (c) "air carrier of the United Kingdom" means an air carrier that fulfils the conditions laid down in point (a) of Article 422(1) or Article 422(2); (d) "air navigation services" means air traffic services, communication, navigation and surveillance services, meteorological services for air navigation, and aeronautical information services; (e) "air operator certificate" means a document issued to an air carrier which affirms that the air carrier in question has the professional ability and organisation to secure the safe operation of aircraft for the aviation activities specified in the certificate; (f) "air traffic management" means the aggregation of the airborne and ground-based functions (air traffic services, airspace management and air traffic flow management) required to ensure the safe and efficient movement of aircraft during all phases of operations; (g) "air transport" means the carriage by aircraft of passengers, baggage, cargo, and mail, separately or in combination, held out to the public for remuneration or hire; (h) "citizenship determination" means a finding that an air carrier proposing to operate air services under this Title satisfies the requirements of Article 422 regarding its ownership, effective control and principal place of business; (i) "competent authorities" means, for the United Kingdom, the authorities of the United Kingdom responsible for the regulatory and administrative functions incumbent on the United Kingdom under this Title; and for the Union, the authorities of the Union and of the Member States responsible for the regulatory and administrative functions incumbent on the Union under this Title; (j) "the Convention" means the Convention on International Civil Aviation, done at Chicago on 7 December 1944, and includes: (i) any amendment that has entered into force under Article 94(a) of the Convention and has been ratified by the United Kingdom and the Member State or Member States concerned, as is relevant to the issue in question; and (ii) any Annex or any amendment thereto adopted under Article 90 of the Convention, insofar as such Annex or amendment is at any given time effective for the United Kingdom and the Member State or Member States concerned, as is relevant to the issue in question; (k) "discrimination" means differentiation of any kind without objective justification in respect of the supply of goods or services, including public services, employed for the operation of air transport services, or in respect of their treatment by public authorities relevant to such services; (l) "effective control" means a relationship constituted by rights, contracts or any other means which, either separately or jointly, and having regard to the considerations of fact or law involved, confer the possibility of directly or indirectly exercising a decisive influence on an undertaking, in particular by: (i) the right to use all or part of the assets of an undertaking; (ii) rights or contracts which confer a decisive influence on the composition, voting or decisions of the bodies of an undertaking or otherwise confer a decisive influence on the running of the business of the undertaking; (m) "fitness determination" means a finding that an air carrier proposing to operate air services under this Title has satisfactory financial capability and adequate managerial expertise to operate such services and is disposed to comply with the laws, regulations and requirements that govern the operation of such services; (n) "full cost" means the cost of the service provided, which may include appropriate amounts for cost of capital and depreciation of assets, as well as the costs of maintenance, operation, management and administration; (o) "ICAO" means the United Nations International Civil Aviation Organization; (p) "principal place of business" means the head office or registered office of an air carrier within which the principal financial functions and operational control, including continued airworthiness management, of that air carrier are exercised; (q) "ramp inspection" means an examination by the competent authority of a Party or its designated representatives, on board and around an aircraft of the other Party, to check both the validity of the relevant aircraft documents and those of its crew members and the apparent condition of the aircraft and its equipment; (r) "self-handling" means the performance of ground handling operations by an air carrier directly for itself or for another air carrier where: (i) one holds the majority in the other; or (ii) a single body has a majority holding in each; (s) "scheduled air transport services" means air services which are scheduled and performed for remuneration according to a published timetable, or which are so regular or frequent as to constitute a recognisably systematic series, and which are open to direct booking by members of the public; and extra section flights occasioned by overflow traffic from scheduled flights; (t) "stop for non-traffic purposes" means a landing for any purpose other than taking on board or discharging passengers, baggage, cargo and/or mail in air transport; (u) "tariff" means any fare, rate or charge for the carriage of passengers, baggage or cargo (excluding mail) in air transport (including any other mode of transport in connection therewith) charged by air carriers, including their agents, and the conditions governing the availability of such fare, rate or charge; (v) "user charge" means a charge imposed on air carriers for the provision of airport, air navigation (including overflights), aviation security facilities or services including related services and facilities, or environment-related charges including noise-related charges and charges to address local air quality problems at or around airports. Article 418 Route schedule 1. Subject to Article 419, the Union shall grant the United Kingdom the right for the air carriers of the United Kingdom to operate, while carrying out air transport, on the following routes: Points in the territory of the United Kingdom – Intermediate Points – Points in the territory of the Union – Points Beyond. 2. Subject to Article 419, the United Kingdom shall grant the Union the right for the air carriers of the Union to operate, while carrying out air transport, on the following routes: Points in the territory of the Union – Intermediate Points – Points in the territory of the United Kingdom – Points Beyond. Article 419 Traffic rights 1. Each Party shall grant to the other Party the right for its respective air carriers, for the purpose of carrying out air transport on the routes laid down in Article 418, to: (a) fly across its territory without landing; (b) make stops in its territory for non-traffic purposes. 2. The United Kingdom shall enjoy the right for its air carriers to make stops in the territory of the Union to provide scheduled and non-scheduled air transport services between any points situated in the territory of the United Kingdom and any points situated in the territory of the Union (third and fourth freedom traffic rights). 3. The Union shall enjoy the right for its air carriers to make stops in the territory of the United Kingdom to provide scheduled and non-scheduled air transport services between any points situated in the territory of the Union and any points situated in the territory of the United Kingdom (third and fourth freedom traffic rights). 4. Notwithstanding paragraphs 1, 2 and 3 and without prejudice to paragraph 9, the Member States and the United Kingdom may, subject to the respective internal rules and procedures of the Parties, enter into bilateral arrangements by which, as a matter of this Agreement, they grant each other the following rights: (a) for the United Kingdom, the right for its air carriers to make stops in the territory of the Member State concerned to provide scheduled and non-scheduled all-cargo air transport services, between points situated in the territory of that Member State and points situated in a third country as part of a service with origin or destination in the territory of the United Kingdom (fifth freedom traffic rights); (b) for the Member State concerned, the right for Union air carriers to make stops in the territory of the United Kingdom to provide scheduled and non-scheduled all-cargo air transport services between points situated in the territory of the United Kingdom and points situated in a third country, as part of a service with origin or destination in the territory of that Member State (fifth freedom traffic rights). 5. The rights mutually granted in accordance with paragraph 4 shall be governed by the provisions of this Title. 6. Neither Party shall unilaterally limit the volume of traffic, capacity, frequency, regularity, routing, origin or destination of the air transport services operated in accordance with paragraphs 2, 3 and 4, or the aircraft type or types operated for that purpose by the air carriers of the other Party, except as may be required for customs, technical, operational, air traffic management, safety, environmental or health protection reasons, in a non-discriminatory manner, or unless otherwise provided for in this Title. 7. Nothing in this Title shall be deemed to confer on the United Kingdom the right for its air carriers to take on board in the territory of a Member State passengers, baggage, cargo or mail carried for compensation and destined for another point in the territory of that Member State or any other Member State. 8. Nothing in this Title shall be deemed to confer on the Union the right for its air carriers to take on board in the territory of the United Kingdom passengers, baggage, cargo or mail carried for compensation and destined for another point in the territory of the United Kingdom. 9. Subject to the internal rules and procedures of the Parties, the competent authorities of the United Kingdom and of the Member States may authorise non-scheduled air transport services beyond the rights provided for in this Article provided that they do not constitute a disguised form of scheduled services, and may establish bilateral arrangements regarding the procedures to be followed for the handling of, and decisions on, air carriers' applications. Article 420 Code-share and blocked space arrangements 1. Air transport services in accordance with Article 419 may be provided by means of blocked-space or code-share arrangements, as follows: (a) an air carrier of the United Kingdom may act as the marketing carrier with any operating carrier that is an air carrier of the Union or an air carrier of the United Kingdom, or with any operating carrier of a third country which, under Union law or, as applicable, under the law of the Member State or Member States concerned, enjoys the necessary traffic rights as well as the right for its air carriers to exercise those rights by means of the arrangement in question; (b) an air carrier of the Union may act as the marketing carrier with any operating carrier that is an air carrier of the Union or an air carrier of the United Kingdom, or with any operating carrier of a third country which, under United Kingdom law enjoys the necessary traffic rights as well as the right for its air carriers to exercise those rights by means of the arrangement in question; (c) an air carrier of the United Kingdom may act as the operating carrier with any marketing carrier that is an air carrier of the Union or an air carrier of the United Kingdom, or with any marketing carrier of a third country which, under Union law or, as applicable, under the law of the Member State or Member States concerned, enjoys the necessary rights to enter into the arrangement in question; (d) an air carrier of the Union may act as the operating carrier with any marketing carrier that is an air carrier of the Union or an air carrier of the United Kingdom, or with any marketing carrier of a third country which, under United Kingdom law, enjoys the necessary rights to enter into the arrangement in question; (e) in the context of the arrangements provided under points (a) to (d), an air carrier of one Party may act as the marketing carrier in a blocked-space or code-share arrangement, in services between any pair of points of which both origin and destination are situated in the territory of the other Party provided that the following conditions are fulfilled: (i) the conditions laid down in point (a) or (b), as the case may be, as regards the operating carrier; and (ii) the transport service in question forms part of a carriage by the marketing carrier between a point in the territory of its Party and that destination point in the territory of the other Party. 2. An air carrier of one Party may act as the marketing carrier in a blocked-space or code-share arrangement, in services between any pair of points of which one is situated in the territory of the other Party and the other is situated in a third country, provided that the following conditions are fulfilled: (a) the conditions laid down in point (a) or (b) of paragraph 1, as the case may be, as regards the operating carrier; and (b) the transport service in question forms part of a carriage by the marketing carrier between a point in the territory of its Party and that point in a third country. 3. In respect of each ticket sold involving the arrangements referred to in this Article, the purchaser shall be informed upon reservation of which air carrier will operate each sector of the service. Where that is not possible, or in case of change after reservation, the identity of the operating carrier shall be communicated to the passenger as soon as it is established. In all cases, the identity of the operating carrier or carriers shall be communicated to the passenger at check-in, or before boarding where no check-in is required for a connecting flight. 4. The Parties may require the arrangements referred to in this Article to be approved by their competent authorities for the purpose of verifying compliance with the conditions set out therein and with other requirements provided for in this Agreement, in particular as regards competition, safety and security. 5. In no case shall recourse to code-share or blocked-space arrangements result in the air carriers of the Parties exercising traffic rights on the basis of this Agreement other than those provided for in Article 419. Article 421 Operational flexibility The rights mutually granted by the Parties in accordance with Article 419(2), (3) and (4) shall include, within the limits laid down therein, all of the following prerogatives: (a) to operate flights in either or both directions; (b) to combine different flight numbers within one aircraft operation; (c) to serve points in the route schedule in any combination and in any order; (d) to transfer traffic between aircraft of the same air carrier at any point (change of gauge); (e) to carry stopover traffic through any points whether within or outside the territory of either Party; (f) to carry transit traffic through the territory of the other Party; (g) to combine traffic on the same aircraft regardless of where such traffic originates; (h) to serve more than one point on the same service (co-terminalisation). Article 422 Operating authorisations and technical permissions 1. On receipt of an application for an operating authorisation from an air carrier of a Party, in the form and manner prescribed, to operate air transport services under this Title, the other Party shall grant the appropriate authorisations and technical permissions with minimum procedural delay, provided that all the following conditions are met: (a) in the case of an air carrier of the United Kingdom: (i) the air carrier is owned, directly or through majority ownership, and is effectively controlled by the United Kingdom, its nationals, or both; (ii) the air carrier has its principal place of business in the territory of the United Kingdom, and is licenced in accordance with the law of the United Kingdom; and (iii) the air carrier holds an air operator certificate issued by the competent authority of the United Kingdom, which shall be clearly identified, and that authority exercises and maintains effective regulatory control of the air carrier; (b) in the case of an air carrier of the Union: (i) the air carrier is owned, directly or through majority ownership, and is effectively controlled by one or more Member States, by other member states of the European Economic Area, by Switzerland, by nationals of such states, or by a combination thereof; (ii) the air carrier has its principal place of business in the territory of the Union and holds a valid operating licence in accordance with Union law; and (iii) the air carrier holds an air operator certificate issued by the competent authority of a Member State, or by a Union authority on its behalf, the certifying authority is clearly identified, and that Member State exercises and maintains effective regulatory control of the air carrier. (c) Articles 434 and 435 are being complied with, and (d) the air carrier meets the conditions prescribed under the laws and regulations normally applied to the operation of international air transport by the Party considering the application or applications. 2. Notwithstanding point (a)(i) of paragraph 1, the appropriate operating authorisations and permissions shall be granted to air carriers of the United Kingdom provided that all the following conditions are met: (a) the conditions laid down in points (a)(ii), (a)(iii), (c) and (d) of paragraph 1 are complied with; (b) the air carrier is owned, directly or through majority ownership, and is effectively controlled by one or more Member States, by other member states of the European Economic Area, by Switzerland, by nationals of such states, or by a combination thereof, whether alone or together with the United Kingdom and/or nationals of the United Kingdom; (c) on the day the transition period ended the air carrier held a valid operating licence in accordance with Union Law. 3. For the purposes of paragraphs 1 and 2, evidence of effective regulatory control includes but is not limited to: (a) the air carrier concerned holding a valid operating licence or permit issued by the competent authority and meeting the criteria of the Party issuing the operating licence or permit for the operation of international air services; and (b) that Party having and maintaining safety and security oversight programmes for that air carrier in compliance with ICAO standards. 4. When granting operating authorisations and technical permissions, each Party shall treat all air carriers of the other Party in a non-discriminatory manner. 5. On receipt of an application for an operating authorisation from an air carrier of a Party, the other Party shall recognise any fitness determination or citizenship determination or both made by the first Party with respect to that air carrier as if such determination had been made by its own competent authorities, and shall not enquire further into such matters, except as provided for in Article 424(3). Article 423 Operating plans, programmes and schedules Notification of operating plans, programmes or schedules for air services operated under this Title may be required by a Party for information purposes only. Where a Party requires such notification, it shall minimise the administrative burden associated with its notification requirements and procedures that is borne by air transport intermediaries and the air carriers of the other Party. Article 424 Refusal, revocation, suspension or limitation of operating authorisation 1. The Union may take action against an air carrier of the United Kingdom, in accordance with paragraphs 3, 4 and 5 of this Article, in any of the following cases: (a) in the case of authorisations and permissions granted in accordance with point (a) of Article 422(1), any of the conditions laid down therein is not met; (b) in the case of authorisations and permissions granted in accordance with Article 422(2), any of the conditions laid down therein is not met; (c) the air carrier has failed to comply with the laws and regulations referred to in Article 426; or (d) such action is necessary in order to prevent, protect against or control the spread of disease, or otherwise protect public health. 2. The United Kingdom may take action against an air carrier of the Union in accordance with paragraphs 3, 4 and 5 of this Article in any of the following cases: (a) any of the conditions laid down in point (b) of Article 422(1) is not met; (b) the air carrier has failed to comply with the laws and regulations referred to in Article 426; or (c) such action is necessary in order to prevent, protect against or control the spread of disease, or otherwise protect public health. 3. Where a Party has reasonable grounds to believe that an air carrier of the other Party is in any of the situations referred to in paragraph 1 or 2, as the case may be, and that action must be taken in that respect, that Party shall notify the other Party in writing as soon as possible of the reasons for the intended refusal, suspension or limitation of the operating authorisation or technical permission and request consultations. 4. Such consultations shall start as soon as possible, and not later than 30 days from receipt of the request for consultations. Failure to reach a satisfactory agreement within 30 days or an agreed time period from the starting date of such consultations, or failure to take the agreed corrective action, shall constitute grounds for the Party that requested the consultations to take action to refuse, revoke, suspend, impose conditions on or limit the operating authorisation or technical permissions of the air carrier or air carriers concerned to ensure compliance with Articles 422 and 426. Where measures have been taken to refuse, revoke, suspend or limit the operating authorisation or technical permission of an air carrier, a Party may have recourse to arbitration in accordance with Article 739, without having prior recourse to consultations in accordance with Article 738. An arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. At the request of a Party, the tribunal may, pending its final ruling, order the adoption of interim relief measures, including the modification or suspension of measures taken by either Party under this Article. 5. Notwithstanding paragraphs 3 and 4, in the cases referred to in points (c) and (d) of paragraph 1, and in points (b) and (c) of paragraph 2, a Party may take immediate or urgent action where required by an emergency or to prevent further non-compliance. For the purposes of this paragraph, further non-compliance means that the question of non-compliance has already been raised between the competent authorities of the Parties. 6. This Article is without prejudice to the provisions of Title XI of Heading One, Article 427(4), Article 434(4), (6) and (8) and Article 435(12) and to the dispute settlement procedure laid down in Title I of Part Six or to the measures resulting therefrom. Article 425 Ownership and control of air carriers The Parties recognise the potential benefits of the continued liberalisation of ownership and control of their respective air carriers. The Parties agree to examine in the Specialised Committee on Air Transport options for the reciprocal liberalisation of the ownership and control of their air carriers within 12 months from the entry into force of this Agreement, and thereafter within 12 months of receipt of a request to do so from one of the Parties. As a result of this examination, the Parties may decide to amend this Title. Article 426 Compliance with laws and regulations 1. The laws and regulations of a Party relating to the admission to, operation within, and departure from its territory of aircraft engaged in international air transport shall be complied with by the air carriers of the other Party while entering, operating within, or leaving the territory of that Party, respectively. 2. The laws and regulations of a Party relating to the admission to, operation within, or departure from its territory of passengers, crew, baggage, cargo, or mail on aircraft (including regulations relating to entry, clearance, immigration, passports, customs and quarantine, or in the case of mail, postal regulations) shall be complied with by, or on behalf of, such passengers, crew, baggage, cargo, and mail carried by the air carriers of the other Party while entering, operating within, or leaving the territory of that Party, respectively. 3. The Parties shall permit, in their respective territory, the air carriers of the other Party to take appropriate measures to ensure that only persons with the travel documents required for entry into or transit through the territory of the other Party are carried. Article 427 Non-Discrimination 1. Without prejudice to Title XI of Heading One, the Parties shall eliminate, within their respective jurisdictions, all forms of discrimination which would adversely affect the fair and equal opportunity of the air carriers of the other Party to compete in the exercise of the rights provided for in this Title. 2. A Party (the "initiating Party") may proceed in accordance with paragraphs 3 to 6 where it considers that its air carriers' fair and equal opportunities to compete in the exercise of the rights provided for in this Title are adversely affected by discrimination prohibited by paragraph 1. 3. The initiating Party shall submit a written request for consultations to the other Party (the "responding Party"). Consultations shall start within a period of 30 days from the receipt of the request, unless otherwise agreed by the Parties. 4. Where the initiating Party and the responding Party fail to reach agreement on the matter within 60 days from the receipt of the request for consultations referred to in paragraph 3, the initiating Party may take measures against all or part of the air carriers which have benefitted from discrimination prohibited by paragraph 1, including action to refuse, revoke, suspend, impose conditions on or limit the operating authorisations or technical permissions of the air carriers concerned. 5. The measures taken pursuant to paragraph 4 shall be appropriate, proportionate and restricted in their scope and duration to what is strictly necessary to mitigate the injury to the air carriers of the initiating Party and remove the undue advantage gained by the air carriers against which they are directed. 6. Where consultations have not resolved the matter or where measures have been taken pursuant to paragraph 4 of this Article, a Party may have recourse to arbitration in accordance with Article 739, without having prior recourse to consultations in accordance with Article 738. An arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. At the request of a Party, the tribunal may, pending its final ruling, order the adoption of interim relief measures, including the modification or suspension of measures taken by either Party under this Article. 7. Notwithstanding paragraph 2, the Parties shall not proceed under paragraphs 3 to 6 in relation to conduct falling under the scope of Title XI of Heading One. Article 428 Doing business 1. The Parties agree that obstacles to doing business encountered by air carriers would hamper the benefits under this Title. The Parties agree to cooperate in removing obstacles to doing business for air carriers of both Parties where such obstacles may hamper commercial operations, create distortions to competition or affect equal opportunities to compete. 2. The Specialised Committee on Air Transport shall monitor progress in effectively addressing matters relating to obstacles to doing business for air carriers. Article 429 Commercial operations 1. The Parties shall grant each other the rights laid down in paragraphs 2 to 7. For the purposes of the exercise of those rights, the air carriers of each Party shall not be required to retain a local sponsor. 2. As regards air carrier representatives: (a) the establishment of offices and facilities by the air carriers of one Party in the territory of the other Party as necessary to provide services under this Title shall be allowed without restriction or discrimination; (b) without prejudice to safety and security regulations, where such offices and facilities are located in an airport they may be subject to limitations on grounds of availability of space; (c) each Party shall, in accordance with its laws and regulations relating to entry, residence and employment, authorise the air carriers of the other Party to bring in and maintain in the territory of the authorising Party those of their own managerial, sales, technical, operational, and other specialist staff which the air carrier reasonably considers necessary for the provision of air transport services under this Title. Where employment authorisations are required for the personnel referred to in this paragraph, including those performing certain temporary duties, the Parties shall process applications for such authorisations expeditiously, subject to the relevant laws and regulations. 3. As regards ground handling: (a) each Party shall permit the air carriers of the other Party to perform self-handling in its territory without restrictions other than those based on considerations of safety or security, or otherwise resulting from physical or operational constraints; (b) each Party shall not impose on the air carriers of the other Party the choice of one or more providers of ground handling services among those which are present in the market in accordance with the laws and regulations of the Party where the services are provided; (c) without prejudice to point (a), where the laws and regulations of a Party limit or restrict in any way free competition between providers of ground handling services, that Party shall ensure that all necessary ground handling services are available to the air carriers of the other Party and that they are provided under no less favourable terms than those under which they are provided to any other air carrier. 4. As regards the allocation of slots at airports, each Party shall ensure that its regulations, guidelines and procedures for allocation of slots at the airports in its territory are applied in a transparent, effective, non-discriminatory and timely manner. 5. As regards local expenses and transfer of funds and earnings: (a) the provisions of Title IV of Heading One apply to the matters governed by this Title, without prejudice to Article 422; (b) the Parties shall grant each other the benefits laid down in points (c) to (e); (c) it shall be possible for the sale and purchase of transport and related services by the air carriers of the Parties, at the discretion of the air carrier, to be denominated in pounds sterling if the sale or purchase takes place in the territory of the United Kingdom, or, if the sale or purchase take place in the territory of a Member State, to be denominated in the currency of that Member State; (d) the air carriers of each Party shall be permitted to pay for local expenses in local currency, at their discretion; (e) the air carriers of each Party shall be permitted, on demand, to remit revenues obtained in the territory of the other Party from the sale of air transport services and associated activities directly linked to air transport in excess of sums locally disbursed, at any time, in any way, to the country of their choice. Prompt conversion and remittance shall be permitted without restrictions or taxation in respect thereof at the market rate of exchange applicable to current transactions and remittance on the date the carrier makes the initial application for remittance and shall not be subject to any charges except those normally made by banks for carrying out such conversion and remittance. 6. As regards intermodal transport: (a) in relation to the transport of passengers, the Parties shall not subject surface transport providers to laws and regulations governing air transport on the sole basis that such surface transport is held out by an air carrier under its own name; (b) subject to any conditions and qualifications set out in Title II of Heading One and its Annexes and in Title I of Heading Three and its Annex, air carriers of each Party shall be permitted, without restriction, to employ in connection with international air transport any surface transport for cargo to or from any points in the territories of the Parties, or in third countries, including transport to and from all airports with customs facilities, and including, where applicable, the right to transport cargo in bond under applicable laws and regulations. Such cargo, whether moving by surface or by air, shall have access to airport customs processing and facilities. Air carriers may elect to perform their own surface transport or to provide it through arrangements, including code share, with other surface transport providers, including surface transport operated by other air carriers and indirect providers of cargo air transport. Such inter-modal cargo services may be offered as a through service and at a single price for the air and surface transport combined, provided that shippers are informed as to the providers of the transport involved. 7. As regards leasing: (a) the Parties shall grant each other the right for their air carriers to provide air transport services in accordance with Article 419 in all the following ways: (i) using aircraft leased without crew from any lessor; (ii) in the case of air carriers of the United Kingdom, using aircraft leased with crew from other air carriers of the Parties; (iii) in the case of air carriers of the Union, using aircraft leased with crew from other air carriers of the Union; (iv) using aircraft leased with crew from air carriers other than those referred to in points (ii) and (iii), respectively, provided that the leasing is justified on the basis of exceptional needs, seasonal capacity needs or operational difficulties of the lessee, and the leasing does not exceed the duration which is strictly necessary to fulfil those needs or overcome those difficulties; (b) the Parties may require leasing arrangements to be approved by their competent authorities for the purpose of verifying compliance with the conditions set out in this paragraph and with the applicable safety and security requirements; (c) however, where a Party requires such approval, it shall endeavour to expedite the approval procedures and minimise the administrative burden on the air carriers concerned; (d) the provisions of this paragraph are without prejudice to the laws and regulations of a Party as regards the leasing of aircraft by air carriers of that Party. Article 430 Fiscal provisions 1. On arriving in the territory of one Party, aircraft operated in international air transport by the air carriers of the other Party, their regular equipment, fuel, lubricants, consumable technical supplies, ground equipment, spare parts (including engines), aircraft stores (including but not limited to such items as food, beverages and liquor, tobacco and other products destined for sale to, or use by, passengers in limited quantities during flight) and other items intended for or used solely in connection with the operation or servicing of aircraft engaged in international air transport shall, on the basis of reciprocity, and provided that such equipment and supplies remain on board the aircraft, be exempt from all import restrictions, property taxes and capital levies, customs duties, excise taxes, inspection fees, value added tax or other similar indirect taxes, and similar fees and charges imposed by the national or local authorities or the Union. 2. The following goods shall also be exempt, on the basis of reciprocity, from the taxes, levies, duties, fees and charges referred to in paragraph 1: (a) aircraft stores introduced into or supplied in the territory of a Party and taken on board, within reasonable limits, for use on outbound aircraft of an air carrier of the other Party used in international air transport, even when these stores are to be used on a part of the journey performed over the said territory; (b) ground equipment and spare parts (including engines) introduced into the territory of a Party for the servicing, maintenance, or repair of aircraft of an air carrier of the other Party used in international air transport; (c) lubricants and consumable technical supplies other than fuel introduced into or supplied in the territory of a Party for use in an aircraft of an air carrier of the other Party used in international air transport, even when those supplies are to be used on a part of the journey performed over the said territory; and (d) printed matter, as provided for by the customs legislation of each Party, introduced into or supplied in the territory of one Party and taken on board for use on outbound aircraft of an air carrier of the other Party engaged in international air transport, even when those stores are to be used on a part of the journey performed over the said territory. 3. The regular airborne equipment, as well as the material, supplies and spare parts referred to in paragraph 1 normally retained on board aircraft operated by an air carrier of one Party may be unloaded in the territory of the other Party only with the approval of the customs authorities of that Party and may be required to be kept under the supervision or control of the said authorities up to such time as they are re-exported or otherwise disposed of in accordance with applicable regulations. 4. The relief from customs duties, national excise duties and similar national fees provided for in this Article shall also be available in situations where the air carrier or air carriers of one Party have entered into arrangements with another air carrier or air carriers for the loan or transfer in the territory of the other Party of the items specified in paragraphs 1 and 2, provided that such other air carrier or air carriers similarly enjoy such relief from that other Party. 5. Nothing in this Title shall prevent either Party from imposing taxes, levies, duties, fees or charges on goods sold other than for consumption on board to passengers during a sector of an air service between two points within its territory at which embarkation or disembarkation is permitted. 6. Baggage and cargo in direct transit across the territory of a Party shall be exempt from taxes, customs duties, fees and other similar charges. 7. Equipment and supplies referred to in paragraph 2 may be required to be kept under the supervision or control of the competent authorities. 8. The provisions of the respective conventions in force between the United Kingdom and Member States for the avoidance of double taxation on income and on capital remain unaffected by this Title. 9. The relief from customs duties, national excise duties and similar national fees shall not extend to charges based on the cost of services provided to an air carrier of a Party in the territory of the other Party. Article 431 User charges 1. User charges that may be imposed by one Party on the air carriers of the other Party for the use of air navigation and air traffic control shall be cost-related and non-discriminatory. In any event, any such user charges shall be assessed on the air carriers of the other Party on terms not less favourable than the most favourable terms available to any other air carrier in like circumstances at the time the charges are applied. 2. Without prejudice to Article 429(5), each Party shall ensure that user charges other than those mentioned in paragraph 1 that may be imposed on the air carriers of the other Party are just, reasonable, not unjustly discriminatory, and equitably apportioned among categories of users. User charges imposed on the air carriers of the other Party may reflect, but not exceed, the full cost of providing appropriate airport, airport environmental and aviation security facilities and services at the airport or within the airport system. Such charges may include a reasonable return on assets after depreciation. Facilities and services for which user charges are imposed shall be provided on an efficient and economic basis. In any event, any such user charges shall be assessed on the air carrier of the other Party on terms no less favourable than the most favourable terms available to any other air carrier in like circumstances at the time the charges are applied. 3. In order to ensure the correct application of the principles set out in paragraphs 1 and 2, each Party shall ensure that consultations take place between the competent charging authorities or bodies in its territory and the air carriers using the services and facilities concerned and that the competent charging authorities or bodies and the air carriers exchange such information as may be necessary. Each Party shall ensure that the competent charging authorities provide users with reasonable notice of any proposal for changes in user charges to enable users to express their views before any changes are made. Article 432 Tariffs 1. The Parties shall allow tariffs to be freely established by the air carriers of the Parties on the basis of fair competition in accordance with this Title. 2. The Parties shall not subject the tariffs of each other's air carriers to approval. Article 433 Statistics 1. The Parties shall cooperate within the framework of the Specialised Committee on Air Transport to facilitate the exchange of statistical information related to air transport under this Title. 2. Upon request, each Party shall provide the other Party with non-confidential and non-commercially sensitive available statistics related to air transport under this Title, as required by the respective laws and regulations of the Parties, on a non-discriminatory basis, and as may reasonably be required. Article 434 Aviation safety 1. The Parties reaffirm the importance of close cooperation in the field of aviation safety. 2. Certificates of airworthiness, certificates of competency and licences issued or rendered valid by one Party and still in force shall be recognised as valid by the other Party and its competent authorities, for the purpose of operating air services under this Title, provided that such certificates or licences were issued or rendered valid pursuant to, and in conformity with, as a minimum, the relevant international standards established under the Convention. 3. Each Party may request consultations at any time concerning the safety standards maintained and administered by the other Party in areas relating to aeronautical facilities, flight crew, aircraft and the operation of aircraft. Such consultations shall take place within 30 days of the request. 4. If, following such consultations, one Party finds that the other Party does not effectively maintain and administer safety standards in the areas referred to in paragraph 2 that are at least equal to the minimum standards established at that time pursuant to the Convention, the first Party shall notify the other Party of those findings and the steps considered necessary to conform with those minimum standards, and the other Party shall take appropriate corrective action. Failure by the other Party to take appropriate action within 15 days or such other period as may be agreed shall be grounds for the requesting Party to refuse, revoke, suspend, impose conditions on or limit the operating authorisations or technical permissions, or to otherwise refuse, revoke, suspend, impose conditions on or limit the operations of the air carriers under the safety oversight of the other Party. 5. Any aircraft operated by, or, under a lease arrangement, on behalf of, an air carrier or air carriers of one Party may, while within the territory of the other Party, be made the subject of a ramp inspection, provided that this does not lead to unreasonable delay in the operation of the aircraft. 6. The ramp inspection or series of ramp inspections can give rise to: (a) serious concerns that an aircraft or the operation of an aircraft does not comply with the minimum standards established at that time pursuant to the Convention; or (b) serious concerns that there is a lack of effective maintenance and administration of safety standards established at that time pursuant to the Convention. In the event that the Party that conducted the ramp inspection or inspections establishes serious concerns as referred to in point (a) or (b), it shall notify the competent authorities of the other Party that are responsible for the safety oversight of the air carrier operating the aircraft of such findings and inform them of the steps considered necessary to conform with those minimum standards. Failure to take appropriate corrective action within 15 days or such other period as may be agreed shall constitute grounds for the first Party to refuse, revoke, suspend, impose conditions on or limit the operating authorisations or technical permissions or to otherwise refuse, revoke, suspend, impose conditions on or limit the operations of the air carrier operating the aircraft. 7. In the event that access for the purpose of undertaking a ramp inspection of an aircraft operated by the air carrier or air carriers of one Party in accordance with paragraph 5 is denied, the other Party shall be free to infer that serious concerns as referred to in paragraph 6 arise and proceed in accordance with paragraph 6. 8. Each Party reserves the right to immediately revoke, suspend or limit the operating authorisations or technical permissions or to otherwise suspend or limit the operations of an air carrier or air carriers of the other Party, if the first Party concludes as a result of a ramp inspection, a series of ramp inspections, a denial of access for ramp inspection, consultation or otherwise, that immediate action is essential to the safety of an air carrier operation. The Party taking such measures shall promptly inform the other Party, providing reasons for its action. 9. Any action by one Party in accordance with paragraph 4, 6 or 8 shall be discontinued once the basis for the taking of that action ceases to exist. 10. Where measures have been taken by a Party pursuant to paragraph 4, 6 or 8, in the event of a dispute a Party may have recourse to arbitration in accordance with Article 739, without having prior recourse to consultations in accordance with Article 738. An arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. At the request of the complaining Party, the tribunal may, pending its final ruling, order the adoption of interim relief measures, including the modification or suspension of measures taken by either Party under this Article. Article 435 Aviation security 1. The Parties shall provide upon request all necessary assistance to each other to address any threat to the security of civil aviation, including the prevention of acts of unlawful seizure of civil aircraft and other unlawful acts against the safety of such aircraft, of their passengers and crew, airports and air navigation facilities, and any other threat to the security of civil aviation. 2. The Parties shall, in their mutual relations, act in conformity with the aviation security standards established by ICAO. They shall require that operators of the aircraft in their registries and the operators of airports in their territory, act, at least, in conformity with such aviation security standards. Each Party shall, on request, provide the other Party notification of any difference between its laws, regulations and practices and the aviation security standards referred to in this paragraph. Each Party may at any time request consultations, to be held without delay, with the other Party to discuss those differences. 3. Each Party shall ensure that effective measures are taken within its territory to protect civil aviation against acts of unlawful interference, including, but not limited to, screening of passengers and their cabin baggage, screening of hold baggage, screening and security controls for persons other than passengers, including crew, and their items carried, screening and security controls for cargo, mail, in-flight and airport supplies, and access control to airside and security restricted areas. Each Party agrees that the security provisions of the other Party relating to the admission to, operating within, or departure from its territory of aircraft shall be observed. 4. The Parties shall endeavour to cooperate on aviation security matters to the highest extent, to exchange information on threat, vulnerability and risk, subject to the mutual agreement of appropriate arrangements for the secure transfer, use, storage and disposal of classified information, to discuss and share best practices, performance and detection standards of security equipment, compliance monitoring best practices and results, and in any other area that the Parties may identify. In particular, the Parties shall endeavour to develop and maintain cooperation arrangements between technical experts on the development and recognition of aviation security standards with the aim of facilitating such cooperation, reducing administrative duplication and fostering early notice and prior discussion of new security initiatives and requirements. 5. Each Party shall make available to the other Party on request the results of audits carried out by ICAO and the corrective actions taken by the audited state, subject to the mutual agreement of appropriate arrangements for the secure transfer, use, storage and disposal of such information. 6. The Parties agree to cooperate on security inspections undertaken by them in the territory of either Party through the establishment of mechanisms, including administrative arrangements, for the reciprocal exchange of information on results of such security inspections. The Parties agree to consider positively requests to participate, as observers, in security inspections undertaken by the other Party. 7. Subject to paragraph 9, and with full regard and mutual respect for the other Party's sovereignty, a Party may adopt security measures for entry into its territory. Where possible, that Party shall take into account the security measures already applied by the other Party and any views that the other Party may offer. Each Party recognises that nothing in this Article limits the right of a Party to refuse entry into its territory of any flight or flights that it deems to present a threat to its security. 8. A Party may take emergency measures to meet a specific security threat. Such measures shall be notified immediately to the other Party. Without prejudice to the need to take immediate action in order to protect aviation security, when considering security measures, a Party shall evaluate possible adverse effects on international air transport and, unless constrained by law, shall take such effects into account when it determines what measures are necessary and appropriate to address the security concerns. 9. With regard to air services bound for its territory, a Party may not require security measures to be implemented in the territory of the other Party. Where a Party considers that a specific threat urgently requires the implementation of temporary measures in addition to the measures already in place in the territory of the other Party, it shall, inform the other Party of the particulars of that threat to the extent consistent with the need to protect security information, and of the proposed measures. The other Party shall give positive consideration to such a proposal, and may decide to implement additional measures as it deems necessary. Such measures shall be proportionate and limited in time. 10. When an incident or threat of an incident of unlawful seizure of civil aircraft or other unlawful acts against the safety of aircraft, passengers, crew, airports or air navigation facilities occurs, the Parties shall assist each other by facilitating communications and other appropriate measures intended to rapidly and safely terminate such incident or threat. 11. Each Party shall take all measures it finds practicable to ensure that an aircraft subjected to an act of unlawful seizure or other acts of unlawful interference which is on the ground in its territory is detained on the ground unless its departure is necessitated by the overriding duty to protect human life. Where practicable, such measures shall be taken on the basis of consultations between the Parties. 12. When a Party has reasonable grounds to believe that the other Party does not comply with this Article, that Party may request immediate consultations with the other Party. Such consultations shall start within 30 days of the receipt of such a request. Failure to reach a satisfactory agreement within 15 days or such other period as may be agreed from the date of such request shall constitute grounds for the Party that requested the consultations to take action to refuse, revoke, suspend, impose conditions on or limit the operating authorisation and technical permissions of an air carrier or air carriers of the other Party to ensure compliance with this Article. When required by an emergency, or to prevent further non-compliance with this Article, a Party may take interim action prior to the expiry of the 15 day-period referred to in this paragraph. 13. Any action taken in accordance with paragraph 8 shall be discontinued when the Party in question considers that the action is no longer required or has been superseded by other measures to mitigate the threat. Any action taken in accordance with paragraph 12 shall be discontinued upon compliance by the other Party with this Article. In the case of action taken in accordance with paragraph 8 or 12, this may be discontinued as mutually agreed by the Parties. 14. Where measures or actions have been taken in accordance with paragraph 7, 8, 9 or 12 of this Article, a Party may have recourse to the dispute settlement provisions of Title I of Part Six. An arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. Article 436 Air traffic management 1. The Parties and their respective competent authorities and air navigation service providers shall cooperate with each other in such a way as to enhance the safe and efficient functioning of air traffic in the European region. The Parties shall seek interoperability between each other's service providers. 2. The Parties agree to cooperate on matters concerning the performance and charging of air navigation services and network functions, with a view to optimising overall flight efficiency, reducing costs, minimising environmental impact and enhancing the safety and capacity of air traffic flows between the existing air traffic management systems of the Parties. 3. The Parties agree to promote cooperation between their air navigation service providers in order to exchange flight data and coordinate traffic flows to optimise flight efficiency, with a view to achieving improved predictability, punctuality and service continuity for air traffic. 4. The Parties agree to cooperate on their air traffic management modernisation programmes, including research, development and deployment activities, and to encourage cross-participation in validation and demonstration activities with the goal of ensuring global interoperability. Article 437 Air carrier liability The Parties reaffirm their obligations under the Convention for the Unification of Certain Rules for International Carriage by Air, done at Montreal on 28 May 1999 (the "Montreal Convention"). Article 438 Consumer protection 1. The Parties share the objective of achieving a high level of consumer protection and shall cooperate to that effect. 2. The Parties shall ensure that effective and non-discriminatory measures are taken to protect the interests of consumers in air transport. Such measures shall include the appropriate access to information, assistance including for persons with disabilities and reduced mobility, reimbursement and, if applicable, compensation in case of denied boarding, cancellation or delays, and efficient complaint handling procedures. 3. The Parties shall consult each other on any matter related to consumer protection, including their planned measures in that regard. Article 439 Relationship to other agreements 1. Subject to paragraphs 4 and 5, earlier agreements and arrangements relating to the subject matter of this Title between the United Kingdom and the Member States, to the extent that they may not have been superseded by the law of the Union, shall be superseded by this Agreement. 2. The United Kingdom and a Member State may not grant each other any rights in connection with air transport to, from or within their respective territories other than those expressly laid down in this Title, save as provided for in Article 419(4) and (9). 3. If the Parties become party to a multilateral agreement, or endorse a decision adopted by ICAO or another international organisation that addresses matters covered by this Title, they shall consult in the Specialised Committee on Air Transport to determine whether this Title should be revised to take into account such developments. 4. Nothing in this Title shall affect the validity and application of existing and future air transport agreements between the Member States and the United Kingdom as regards territories under their respective sovereignty which are not covered by Article 774. 5. Nothing in this Title shall affect any rights available to the United Kingdom and Member States under the Multilateral Agreement on Commercial Rights of Non-Scheduled Air Services in Europe, signed at Paris on 30 April 1956, to the extent that such rights go beyond those laid down in this Title. Article 440 Suspension and Termination 1. A suspension of this Title, in whole or in part, pursuant to Article 749, may be implemented no earlier than the first day of the International Air Transport Association (IATA) traffic season following the season during which the suspension has been notified. 2. Upon termination of this Agreement pursuant to Article 779 or upon termination of this Title pursuant to Article 441 or Article 521 or Article 509, the provisions governing the matters falling within the scope of this Title shall continue to apply beyond the date of cessation referred to in Article 779 or Article 441 or Article 521 or Article 509, until the end of the IATA traffic season in progress on that date. 3. The Party suspending this Title, in whole or in part, or terminating this Agreement or this Title shall inform ICAO thereof. Article 441 Termination of this Title Without prejudice to Article 779, Article 521, and Article 509 each Party may at any moment terminate this Title, by written notification through diplomatic channels. In that event, this Title shall cease to be in force on the first day of the ninth month following the date of notification. Article 442 Registration of this Agreement This Agreement and any amendments thereto shall, insofar as relevant, be registered with ICAO in accordance with Article 83 of the Convention. TITLE II AVIATION SAFETY Article 443 Objectives The objectives of this Title are to: (a) enable the reciprocal acceptance, as provided for in the Annexes to this Title, of findings of compliance made and certificates issued by either Party's competent authorities or approved organisations; (b) promote cooperation toward a high level of civil aviation safety and environmental compatibility; (c) facilitate the multinational dimension of the civil aviation industry; (d) facilitate and promote the free flow of civil aeronautical products and services. Article 444 Definitions For the purposes of this Title, the following definitions apply: (a) "approved organisation" means any legal person certified by the competent authority of either Party to exercise privileges related to the scope of this Title; (b) "certificate" means any approval, licence or other document issued as a form of recognition of compliance that a civil aeronautical product, an organisation or a legal or natural person complies with the applicable requirements set out in laws and regulations of a Party; (c) "civil aeronautical product" means any civil aircraft, aircraft engine, or aircraft propeller, or subassembly, appliance, part or component, installed or to be installed thereon; (d) "competent authority" means a Union or government agency or a government entity responsible for civil aviation safety that is designated by a Party for the purposes of this Title to perform the following functions: (i) to assess the compliance of civil aeronautical products, organisations, facilities, operations and services subject to its oversight with applicable requirements set out in laws, regulations and administrative provisions of that Party; (ii) to conduct monitoring of their continued compliance with these requirements; and (iii) to take enforcement actions to ensure their compliance with these requirements; (e) "findings of compliance" means a determination of compliance with the applicable requirements set out in laws and regulations of a Party as the result of actions such as testing, inspections, qualifications, approvals and monitoring; (f) "monitoring" means the regular surveillance by a competent authority of a Party to determine continuing compliance with the applicable requirements set out in laws and regulations of that Party; (g) "technical agent" means, for the Union, the European Union Aviation Safety Agency ("EASA"), or its successor, and for the United Kingdom, the United Kingdom Civil Aviation Authority ("CAA"), or its successor; and (h) "the Convention" means the Convention on International Civil Aviation, done at Chicago on 7 December 1944, and includes: (i) any amendment that has entered into force under Article 94(a) of the Convention and has been ratified by the United Kingdom and the Member State or Member States concerned, as is relevant to the issue in question; and (ii) any Annex or any amendment thereto adopted under Article 90 of the Convention, insofar as such Annex or amendment is at any given time effective for the United Kingdom and the Member State or Member States concerned, as is relevant to the issue in question. Article 445 Scope and implementation 1. The Parties may cooperate in the following areas: (a) airworthiness certificates and monitoring of civil aeronautical products; (b) environmental certificates and testing of civil aeronautical products; (c) design and production certificates and monitoring of design and production organisations; (d) maintenance organisation certificates and monitoring of maintenance organisations; (e) personnel licensing and training; (f) flight simulator qualification evaluation; (g) operation of aircraft; (h) air traffic management and air navigation services; and (i) other areas related to aviation safety subject to Annexes to the Convention. 2. The scope of this Title shall be established by way of Annexes covering each area of cooperation set out in paragraph 1. 3. The Specialised Committee on Aviation Safety may only adopt Annexes as referred to in paragraph 2 where each Party has established that the civil aviation standards, rules, practices, procedures and systems of the other Party ensure a sufficiently equivalent level of safety to permit acceptance of findings of compliance made and certificates issued by its competent authorities or by organisations approved by those competent authorities. 4. Each Annex referred to in paragraph 2 shall describe the terms, conditions and methods for the reciprocal acceptance of findings of compliance and certificates, and, if necessary, transitional arrangements. 5. The technical agents may develop implementation procedures for each individual Annex. Technical differences between the Parties' civil aviation standards, rules, practices, procedures and systems shall be addressed in the Annexes referred to in paragraph 2 and implementation procedures. Article 446 General obligations 1. Each Party shall accept findings of compliance made and certificates issued by the other Party's competent authorities or approved organisations, in accordance with the terms and conditions set out in the Annexes referred to in Article 445(2). 2. Nothing in this Title shall entail reciprocal acceptance of the standards or technical regulations of the Parties. 3. Each Party shall ensure that its respective competent authorities remain capable and fulfil their responsibilities under this Title. Article 447 Preservation of regulatory authority Nothing in this Title shall be construed as limiting the authority of a Party to determine, through its legislative, regulatory and administrative measures, the level of protection it considers appropriate for safety and the environment. Article 448 Safeguard measures 1. Either Party may take all appropriate and immediate measures whenever it considers that there is a reasonable risk that a civil aeronautical product, a service or any activity that falls within the scope of this Title may compromise safety or the environment, may not meet its applicable legislative, regulatory or administrative measures, or may otherwise fail to satisfy a requirement within the scope of the applicable Annex to this Title. 2. Where either Party takes measures pursuant to paragraph 1, it shall inform the other Party in writing within 15 working days of taking such measures, providing reasons therefor. Article 449 Communication 1. The Parties shall designate and notify each other of a contact point for the communication related to the implementation of this Title. All such communications shall be in the English language. 2. The Parties shall notify to each other a list of the competent authorities, and thereafter an updated list each time that becomes necessary. Article 450 Transparency, regulatory cooperation and mutual assistance 1. Each Party shall ensure that the other Party is kept informed of its laws and regulations related to this Title and any significant changes to such laws and regulations. 2. The Parties shall to the extent possible inform each other of their proposed significant revisions of their relevant laws, regulations, standards, and requirements, and of their systems for issuing certificates insofar as these revisions may have an impact on this Title. To the extent possible, they shall offer each other an opportunity to comment on such revisions and give due consideration to such comments. 3. For the purpose of investigating and resolving specific safety issues, each Party's competent authorities may allow the other Party's competent authorities to participate as observers in each other's oversight activities as specified in the applicable Annex to this Title. 4. For the purpose of monitoring and inspections, each Party's competent authorities shall assist, if necessary, the other Party's competent authorities with the objective of providing unimpeded access to regulated entities subject to its oversight. 5. To ensure the continued confidence by each Party in the reliability of the other Party's processes for findings of compliance, each technical agent may participate as an observer in the other's oversight activities, in accordance with procedures set out in the Annexes to this Title. That participation shall not amount to a systematic participation in oversight activity of the other Party. Article 451 Exchange of safety information The Parties shall, without prejudice to Article 453 and subject to their applicable legislation: (a) provide each other, on request and in a timely manner, with information available to their technical agents related to accidents, serious incidents or occurrences in relation to civil aeronautical products, services or activities covered by the Annexes to this Title; and (b) exchange other safety information as the technical agents may agree. Article 452 Cooperation in enforcement activities The Parties shall, through their technical agents or competent authorities, provide when requested, subject to applicable laws and regulations, as well as to the availability of required resources, mutual cooperation and assistance in investigations or enforcement activities regarding any alleged or suspected violation of laws or regulations falling within the scope of this Title. In addition, each Party shall promptly notify the other Party of any investigation when mutual interests are involved. Article 453 Confidentiality and protection of data and information 1. Each Party shall, in accordance with its laws and regulations, maintain the confidentiality of data and information received from the other Party under this Title. Such data and information may only be used by the Party receiving the data and information for the purposes of this Title. 2. In particular, subject to their respective laws and regulations, the Parties shall neither disclose to a third party, including the public, nor permit their competent authorities to disclose to a third party, including the public, any data and information received from the other Party under this Title that constitutes trade secrets, intellectual property, confidential commercial or financial information, proprietary data, or information that relates to an ongoing investigation. To that end, such data and information shall be considered to be confidential. 3. A Party or a competent authority of a Party may, upon providing data or information to the other Party or a competent authority of the other Party, designate data or information that it considers to be confidential and not to be subject to disclosure. In that case, the Party or its competent authority shall clearly mark such data or information as confidential. 4. If a Party disagrees with the designation made by the other Party or a competent authority of that Party in accordance with paragraph 3, the former Party may request consultations with the other Party to address the issue. 5. Each Party shall take all reasonable precautions necessary to protect data and information, received under this Title, from unauthorised disclosure. 6. The Party receiving data and information from the other Party under this Title shall not acquire any proprietary rights on such data and information by reason of its receipt from the other Party. Article 454 Adoption and amendments of Annexes to this Title The Specialised Committee on Aviation Safety may amend Annex 30, adopt or amend Annexes as provided for in Article 445(2) and delete any Annex. Article 455 Cost recovery Each Party shall endeavour to ensure that any fees or charges imposed by a Party or its technical agent on a legal or natural person whose activities are covered by this Title shall be just, reasonable and commensurate with the services provided, and shall not create a barrier to trade. Article 456 Other agreements and prior arrangements 1. Upon entry into force of this Agreement, this Title shall supersede any bilateral aviation safety agreements or arrangements between the United Kingdom and the Member States with respect to any matter covered by this Title that has been implemented in accordance with Article 445. 2. The technical agents shall take necessary measures to revise or terminate, as appropriate, prior arrangements between them. 3. Subject to paragraphs 1 and 2, nothing in this Title shall affect the rights and obligations of the Parties under any other international agreements. Article 457 Suspension of reciprocal acceptance obligations 1. A Party shall have the right to suspend, in whole or in part, its acceptance obligations under Article 446(1), when the other Party materially violates its obligations under this Title. 2. Before exercising its right to suspend its acceptance obligations, a Party shall request consultations for the purpose of seeking corrective measures of the other Party. During the consultations, the Parties shall, where appropriate, consider the effects of the suspension. 3. Rights under this Article shall be exercised only if the other Party fails to take corrective measures within an appropriate period of time following the consultations. If a Party exercises a right under this Article, it shall notify the other Party of its intention to suspend the acceptance obligations in writing and detail the reasons for suspension. 4. Such suspension shall take effect 30 days after the date of the notification, unless, prior to the end of that period, the Party which initiated the suspension notifies the other Party in writing that it is withdrawing its notification. 5. Such suspension shall not affect the validity of findings of compliance made and certificates issued by the competent authorities or approved organisations of the other Party prior to the date the suspension took effect. Any such suspension that has become effective may be rescinded immediately upon an exchange of diplomatic notes to that effect by the Parties. Article 458 Termination of this Title Without prejudice to Article 779, Article 521 and Article 509, each Party may at any moment terminate this Title, by written notification through diplomatic channels. In that event, this Title shall cease to be in force on the first day of the ninth month following the date of notification. HEADING THREE ROAD TRANSPORT TITLE I TRANSPORT OF GOODS BY ROAD Article 459 Objective 1. The objective of this Title is to ensure, as regards the transport of goods by road, continued connectivity between, through and within the territories of the Parties and to lay down the rules which are applicable to such transport. 2. The Parties agree not to take discriminatory measures when applying this Title. 3. Nothing in this Title shall affect the transport of goods by road within the territory of one of the Parties by a road haulage operator established in that territory. Article 460 Scope 1. This Title applies to the transport of goods by road with a commercial purpose between, through and within the territories of the Parties and is without prejudice to the application of the rules established by the European Conference of Ministers of Transport. 2. Any transport of goods by road for which no direct or indirect remuneration is received and which does not directly or indirectly generate any income for the driver of the vehicle or for others, and which is not linked to professional activity shall be considered as the transport of goods for a non-commercial purpose. Article 461 Definitions For the purposes of this Title and in addition to the definitions set out in Article 124, the following definitions apply: (a) "vehicle" means a motor vehicle registered in the territory of a Party, or a coupled combination of vehicles of which the motor vehicle is registered in the territory of a Party, and which is used exclusively for the transport of goods; (b) "road haulage operator" means any natural or legal person engaged in the transport of goods with a commercial purpose, by means of a vehicle; (c) "road haulage operator of a Party" means a road haulage operator which is a legal person established in the territory of a Party or a natural person of a Party; (d) "party of establishment" means the Party in which a road haulage operator is established; (e) "driver" means any person who drives a vehicle even for a short period, or who is carried in a vehicle as part of his duties to be available for driving if necessary; (f) "transit" means the movement of vehicles across the territory of a Party without loading or unloading of goods; (g) "regulatory measures" means: (i) for the Union: (A) regulations and directives, as provided for in Article 288 TFEU; and (B) delegated and implementing acts, as provided for in Articles 290 and 291 TFEU, respectively; and (ii) for the United Kingdom: (A) primary legislation; and (B) secondary legislation. Article 462 Transport of goods between, through and within the territories of the Parties 1. Provided that the conditions in paragraph 2 are fulfilled, road haulage operators of a Party may undertake: (a) laden journeys with a vehicle, from the territory of the Party of establishment to the territory of the other Party, and vice versa, with or without transit through the territory of a third country; (b) laden journeys with a vehicle from the territory of the Party of establishment to the territory of the same Party with transit through the territory of the other Party; (c) laden journeys with a vehicle to or from the territory of the Party of establishment with transit through the territory of the other Party; (d) unladen journeys with a vehicle in conjunction with the journeys referred to in points (a), (b) and (c). 2. Road haulage operators of a Party may only undertake a journey referred to in paragraph 1 if: (a) they hold a valid licence issued in accordance with Article 463, except in the cases referred to in Article 464; and (b) the journey is carried out by drivers who hold a Certificate of Professional Competence in accordance with Article 465(1). 3. Subject to paragraph 6, and provided that the conditions in paragraph 2 are fulfilled, road haulage operators of the United Kingdom may undertake up to two laden journeys from one Member State to another Member State, without returning to the territory of the United Kingdom, provided that such journeys follow a journey from the territory of the United Kingdom permitted under point (a) of paragraph 1. 4. Without prejudice to paragraph 5, subject to paragraph 6 and provided that the conditions in paragraph 2 are fulfilled, road haulage operators of the United Kingdom may undertake one laden journey within the territory of a Member State provided that operation: (a) follows a journey from the territory of the United Kingdom permitted under point (a) of paragraph 1; and (b) is performed within seven days of the unloading in the territory of that Member State of goods carried on the journey referred to in point (a). 5. Subject to paragraph 6 and provided that the conditions in paragraph 2 are fulfilled, road haulage operators of the United Kingdom established in Northern Ireland may undertake up to two laden journeys within the territory of Ireland provided that such operations: (a) follow a journey from the territory of Northern Ireland permitted under point (a) of paragraph 1; and (b) are performed within seven days of the unloading in the territory of Ireland of goods carried on the journey referred to in point (a). 6. Road haulage operators of the United Kingdom shall be limited to a maximum of two journeys within the territory of the Union under paragraphs 3, 4 and 5 before returning to the territory of the United Kingdom. 7. Provided that the conditions in paragraph 2 are fulfilled, road haulage operators of the Union may undertake up to two laden journeys within the territory of the United Kingdom provided that such operations: (a) follow a journey from the territory of the Union permitted under point (a) of paragraph 1; and (b) are performed within seven days of the unloading in the territory of the United Kingdom of the goods carried on the journey referred to in point (a). Article 463 Requirements for operators 1. Road haulage operators of a Party undertaking a journey referred to in Article 462 shall hold a valid licence issued in accordance with paragraph 2 of this Article. 2. Licences shall only be issued, in accordance with the law of the Parties, to road haulage operators who comply with the requirements set out in Section 1 of Part A of Annex 31 governing the admission to, and the pursuit of, the occupation of road haulage operator. 3. A certified true copy of the licence shall be kept on board the vehicle and shall be presented at the request of any inspecting officers authorised by each Party. The licence and the certified true copies shall correspond to one of the models set out in Appendix 31-A-1-3 of Part A to Annex 31, which also lays down the conditions governing its use. The licence shall contain at least two of the security features listed in Appendix 31-A-1-4 to Part A of Annex 31. 4. Road haulage operators shall comply with the requirements set out in Section 2 of Part A of Annex 31 laying down requirements for the posting of drivers when undertaking a journey referred to in Article 462(3) to (7). Article 464 Exemptions from licencing requirement The following types of transport of goods and unladen journeys made in conjunction with such transport may be conducted without a valid licence as referred to in Article 463: (a) transport of mail as a universal service; (b) transport of vehicles which have suffered damage or breakdown; (c) until 20 May 2022, transport of goods in motor vehicles the permissible laden mass of which, including that of trailers, does not exceed 3,5 tonnes; (d) from 21 May 2022, transport of goods in motor vehicles the permissible laden mass of which, including that of trailers, does not exceed 2,5 tonnes; (e) transport of medicinal products, appliances, equipment and other articles required for medical care in emergency relief, in particular for natural disasters and humanitarian assistance; (f) transport of goods in vehicles provided that the following conditions are fulfilled: (i) the goods carried are the property of the road haulage operator or have been sold, bought, let out on hire or hired, produced, extracted, processed or repaired by the operator; (ii) the purpose of the journey is to carry the goods to or from the road haulage operator's premises or to move them, either inside or outside the operator for its own requirements; (iii) the vehicles used for such transport are driven by personnel employed by, or put at the disposal of, the road haulage operator under a contractual obligation; (iv) the vehicles carrying the goods are owned by the road haulage operator, have been bought by it on deferred terms or have been hired; and (v) such transport is no more than ancillary to the overall activities of the road haulage operator; (g) transport of goods by means of motor vehicles with a maximum authorised speed not exceeding 40 km/h. Article 465 Requirements for drivers 1. Drivers of the vehicles undertaking journeys as referred to in Article 462 shall: (a) hold a Certificate of Professional Competence issued in accordance with Section 1 of Part B of Annex 31; and (b) comply with the rules on driving and working time, rest periods, breaks and the use of tachographs in accordance with Sections 2 to 4 of Part B of Annex 31. 2. The European Agreement concerning the Work of Crews of Vehicles Engaged in International Road Transport (AETR), done in Geneva on 1 July 1970, shall apply, instead of point (b) of paragraph 1, to international road transport operations undertaken in part outside the territory of the Parties, for the whole journey. Article 466 Requirements for vehicles 1. A Party shall not reject or prohibit the use in its territory of a vehicle undertaking a journey referred to in Article 462 if the vehicle complies with the requirements set out in Section 1 of Part C of Annex 31. 2. Vehicles undertaking the journeys referred to in Article 462 shall be equipped with a tachograph constructed, installed, used, tested and controlled in accordance with Section 2 of Part C of Annex 31. Article 467 Road traffic rules Drivers of vehicles undertaking the transport of goods under this Title shall, when in the territory of the other Party, comply with the national laws and regulations in force in that territory concerning road traffic. Article 468 Development of laws and Specialised Committee on Road Transport 1. When a Party proposes a new regulatory measure in an area covered by Annex 31, it shall: (a) notify the other Party of the proposed regulatory measure as soon as possible; and (b) keep the other Party informed of progress of the regulatory measure. 2. At the request of one of the Parties, an exchange of views shall take place within the Specialised Committee on Road Transport no later than two months after the submission of the request, as to whether the proposed new regulatory measure would apply to journeys referred to in Article 462, or not. 3. When a Party adopts a new regulatory measure referred to in paragraph 1, it shall notify the other Party, and supply the text of the new regulatory measure within one week of its publication. 4. The Specialised Committee on Road Transport shall meet to discuss any new regulatory measure adopted, on request by either Party within two months of the submission of the request, whether or not a notification has taken place in accordance with paragraph 1 or 3, or a discussion has taken place in accordance with paragraph 2. 5. The Specialised Committee on Road Transport may: (a) amend Annex 31 to take account of regulatory and/or technological developments, or to ensure the satisfactory implementation of this Title; (b) confirm that the amendments made by the new regulatory measure conform to Annex 31; or (c) decide on any other measure aimed at safeguarding the proper functioning of this Title. Article 469 Remedial measures 1. If a Party considers that the other Party has adopted a new regulatory measure that does not comply with the requirements of Annex 31, in particular in cases where the Specialised Committee on Road Transport has not reached a decision under Article 468, and the other Party nevertheless applies the provisions of the new regulatory measure to the Party's road transport operators, drivers or vehicles, the Party may, after notifying the other Party, adopt appropriate remedial measures, including the suspension of obligations under this Agreement or any supplementing Agreement, provided that such measures: (a) do not exceed the level equivalent to the nullification or impairment caused by the new regulatory measure adopted by the other Party that does not comply with the requirements of Annex 31; and (b) take effect at the earliest 7 days after the Party which intends to take such measures has given the other Party notice under this paragraph. 2. The appropriate remedial measures shall cease to apply: (a) when the Party having taken such measures is satisfied that the other Party is complying with its obligations under this Title; or (b) in compliance with a ruling of the arbitration tribunal. 3. A Party shall not invoke the WTO Agreement or any other international agreement to preclude the other Party from suspending obligations under this Article. Article 470 Taxation 1. Vehicles used for the carriage of goods in accordance with this Title shall be exempt from the taxes and charges levied on the possession or circulation of vehicles in the territory of the other Party. 2. The exemption referred to in paragraph 1 shall not apply to: (a) a tax or charge on fuel consumption; (b) a charge for using a road or network of roads; or (c) a charge for using particular bridges, tunnels or ferries. 3. The fuel contained in the standard tanks of the vehicles and of special containers, admitted temporarily, which is used directly for the purpose of propulsion and, where appropriate, for the operation, during transport, of refrigeration systems and other systems, as well as lubricants present in the motor vehicles and required for their normal operation during the journey, shall be free of custom duties and any other taxes and levies, such as VAT and excise duties, and shall not be subject to any import restrictions. 4. The spare parts imported for repairing a vehicle on the territory of one Party that has been registered or put into circulation in the other Party, shall be admitted under cover of a temporary duty-free admission and without prohibition or restriction of importation. The replaced parts are subject to customs duties and other taxes (VAT) and shall be re-exported or destroyed under the control of the customs authorities of the other Party. Article 471 Obligations in other Titles Articles 135 and 137 are incorporated into and made part of this Title and apply to the treatment of road haulage operators undertaking journeys in accordance with Article 462. Article 472 Termination of this Title Without prejudice to Article 779, Article 521 and Article 509, each Party may at any moment terminate this Title, by written notification through diplomatic channels. In that event, this Title shall cease to be in force on the first day of the ninth month following the date of notification. TITLE II TRANSPORT OF PASSENGERS BY ROAD Article 473 Scope 1. The objective of this Title is to ensure, as regards the transport of passengers by road, continued connectivity between, through and within the territories of the Parties and to lay down the rules which are applicable to such transport. It applies to the occasional, regular and special regular transport of passengers by coach and bus between, through and within the territories of the Parties. 2. The Parties agree not to take discriminatory measures when applying this Title. 3. Nothing in this Title shall affect the transport of passengers within the territory of one of the Parties by a road passenger transport operator established in that territory. Article 474 Definitions For the purposes of this Title and in addition to the definitions set out in Article 124, the following definitions apply: (a) "coaches and buses" are vehicles which, by virtue of their construction and their equipment, are suitable for carrying more than nine persons, including the driver, and are intended for that purpose; (b) "passenger transport services" means transport services by road for the public or for specific categories of users, supplied in return for payment by the person transported or by the transport organiser, by means of coaches and buses; (c) "road passenger transport operator" means any natural person or any legal person, whether having its own legal personality or being dependent upon an authority having such a personality, which supplies passenger transport services; (d) "road passenger transport operator of a Party" means a road passenger transport operator which is established in the territory of a Party; (e) "regular services" means passenger transport services supplied at specified frequency along specified routes, whereby passengers may be picked up and set down at predetermined stopping points; (f) "special regular services" means services by whomsoever organised, which provide for the transport of specified categories of passengers to the exclusion of other passengers, in so far as such services are operated under the conditions specified for regular services. Special regular services shall include: (i) the transport of workers between home and work, and (ii) the transport of school pupils and students to and from the educational institution. The fact that a special regular service may be varied according to the needs of users shall not affect its classification as a regular service; (g) "group" means any of the following: (i) one or more associated natural or legal persons and their parent natural or legal person or persons, (ii) one or more associated natural person or legal persons which have the same parent natural or legal person or persons; (h) "Interbus Agreement" means the Agreement on the international occasional carriage of passengers by coach and bus, as subsequently amended, which entered into force on 1 January 2003; (i) "transit" means the movement of coaches and buses across the territory of a Party without picking up or setting down of passengers; (j) "occasional services" means services which are not regular services or special regular services, and which are characterised above all by the fact that they carry groups of passengers assembled at the initiative of the customer or the road passenger transport operator. Article 475 Passenger transport by coach and bus between, through and within the territories of the Parties 1. Road passenger transport operators of a Party may, when operating regular and special regular services, undertake laden journeys from the territory of a Party to the territory of the other Party, with or without transit through the territory of a third country, and unladen journeys related to such journeys. 2. Road passenger transport operators of a Party may, when operating regular and special regular services, undertake laden journeys from the territory of the Party, in which the road passenger transport operator is established, to the territory of the same Party with transit through the territory of the other Party, and unladen journeys related to such journeys. 3. A road passenger transport operator of a Party may not operate regular or special regular services with both origin and destination in the territory of the other Party. 4. Where the passenger transport service referred to in paragraph 1 is part of a service to or from the territory of the Party where the road passenger transport operator is established, passengers may be picked up or set down in the territory of the other Party en route, provided the stop is authorised in accordance with the rules applicable in that territory. 5. Where the passenger transport service referred to in this Article is part of an international regular or special regular service between Ireland and the United Kingdom in respect of Northern Ireland, passengers may be picked up and set down in one Party by a road passenger transport operator established in the other Party. 6. Road passenger transport operators established in the territory of one Party may, on a temporary basis, operate occasional services on the island of Ireland which pick up and set down passengers on the territory of the other Party. 7. Road passenger transport operators may, when operating occasional services, undertake a laden journey from the territory of a Party through the territory of the other Party to the territory of a non-Contracting Party to the Interbus Agreement, including a related unladen journey. 8. The passenger transport services referred to in this Article shall be performed using coaches and buses registered in the Party where the road passenger transport operator is established or resides. Those coaches and buses shall comply with the technical standards laid down in Annex 2 to the Interbus Agreement. Article 476 Conditions for the provision of services referred to in Article 475 1. Regular services shall be open to all road passenger transport operators of a Party, subject to compulsory reservation, where appropriate. 2. Regular and special regular services shall be subject to authorisation in accordance with Article 477, and paragraph 6 of this Article. 3. The regular nature of the service shall not be affected by any adjustment to the service operating conditions. 4. The organisation of parallel or temporary services, serving the same public as existing regular services, the non-serving of certain stops and the serving of additional stops on existing regular services shall be governed by the same rules as those applicable to existing regular services. 5. Sections V (Social provisions) and VI (Custom and fiscal provisions) of the Interbus Agreement as well as Annexes 1 (Conditions applying to road passenger transport operators) and 2 (Technical standards applying to buses and coaches) thereto shall apply. 6. For a period of six months from the date of entry into force of this Agreement, special regular services shall not be subject to authorisation where they are covered by a contract concluded between the organiser and the road passenger transport operator. 7. Occasional services covered by this Title in accordance with Article 475 shall not require authorisation. However, the organisation of parallel or temporary services comparable to existing regular services and serving the same public as the latter shall be subject to authorisation in accordance with Section VIII of the Interbus Agreement. Article 477 Authorisation 1. Authorisations for services referred to in Article 475 shall be issued by the competent authority of the Party in whose territory the road passenger transport operator is established (the "authorising authority"). 2. If a road passenger transport operator is established in the Union, the authorising authority shall be the competent authority of the Member State of origin or destination. 3. In the case of a group of road passenger transport operators intending to operate a service referred to in Article 475, the authorising authority shall be the competent authority to which the application is addressed in accordance with the second subparagraph of Article 478(1). 4. Authorisations shall be issued in the name of the road passenger transport operator and shall be non-transferable. However, a road passenger transport operator of a Party who has received an authorisation may, with the consent of the authorising authority, operate the service through a subcontractor, if such a possibility is in line with the law of the Party. In this case, the name of the subcontractor and its role shall be indicated in the authorisation. The subcontractor shall be a road passenger transport operator of a Party and shall comply with all the provisions of this Title. In the case of a group of road passenger transport operators that intend to operate services referred to in Article 475, the authorisation shall be issued in the names of all the road passenger transport operators of the group and shall state the names of all those operators. It shall be given to the road passenger transport operators entrusted by the other road passenger transport operators of a Party for these purposes and which has requested it, and certified true copies shall be given to the other road passenger transport operators. 5. Without prejudice to Article 479(3), the period of validity of an authorisation shall not exceed five years. It may be set for a shorter period either at the request of the applicant or by mutual consent of the competent authorities of the Parties on whose territories passengers are picked up or set down. 6. Authorisations shall specify the following: (a) the type of service; (b) the route of the service, giving in particular the point of departure and the point of arrival; (c) the period of validity of the authorisation; and (d) the stops and the timetable. 7. Authorisations shall conform to the model set out in Annex 32. 8. The road passenger transport operator of a Party carrying out a service referred to in Article 475 may use additional vehicles to deal with temporary and exceptional situations. Such additional vehicles may be used only under the same conditions as set out in the authorisation referred to in paragraph 6 of this Article. In this case, in addition to the documents referred to in Article 483(1) and (2), the road passenger transport operator shall ensure that a copy of the contract between the road passenger transport operator carrying out the regular or special regular service and the undertaking providing the additional vehicles or an equivalent document is carried in the vehicle and presented at the request of any authorised inspecting officer. Article 478 Submission of application for authorisation 1. Applications for authorisation shall be submitted by the road passenger transport operator of a Party to the authorising authority referred to in Article 477(1). For each service, only one application shall be submitted. In the cases referred to in Article 477(3), it shall be submitted by the operator entrusted by the other operators for these purposes. The application shall be addressed to the authorising authority of the Party in which the road passenger transport operator submitting it is established. 2. Applications for authorisation shall be submitted on the basis of the model set out in Annex 33. 3. The road passenger transport operator applying for authorisation shall provide any further information which it considers relevant or which is requested by the authorising authority, in particular, the documents listed in Annex 33. Article 479 Authorisation procedure 1. Authorisations shall be issued in agreement with the competent authorities in the Parties in whose territory passengers are picked up or set down. The authorising authority shall forward to such competent authorities, as well as to the competent authorities whose territories are crossed without passengers being picked up or set down, a copy of the application, together with copies of any other relevant documentation, and its assessment. In respect of the Union, the competent authorities referred to in the first subparagraph shall be those of the Member States in whose territories passengers are picked up or set down and whose territories are crossed without passengers being picked up or set down. 2. The competent authorities whose agreement has been requested shall notify the authorising authority of their decision regarding the application within four months. This time limit shall be calculated from the date of receipt of the request for agreement which is shown in the acknowledgement of receipt. If the decision received from the competent authorities whose agreement has been requested is negative, it shall contain a proper statement of reasons. If the authorising authority does not receive a reply within four months, the competent authorities consulted shall be deemed to have given their agreement and the authorising authority may grant the authorisation. The competent authorities whose territory is crossed without passengers being picked up or set down may notify the authorising authority of their comments within four months. 3. In respect of services that had been authorised under Regulation (EC) No 1073/2009 of the European Parliament and the Council (70) before the end of the transition period and in respect of which the authorisation lapses at the end of the transition period, the following shall apply: (a) where, subject to the changes necessary to comply with Article 475, the operating conditions are the same as those having been set in the authorisation granted under Regulation (EC) No 1073/2009, the relevant authorising authority under this Title may, on application or otherwise, issue the road transport operator with a corresponding authorisation granted under this Title. Where such an authorisation is issued, the agreement of the competent authorities in whose territories passengers are picked up or set down, as referred to in paragraph 2, shall be deemed to be provided. Those competent authorities and the competent authorities whose territory is crossed without passengers being picked up or set down may, at any time, notify the authorising authority of any comments they may have; (b) where point (a) is applied, the validity period of the corresponding authorisation granted under this Title shall not extend beyond the last day of the validity period specified in the authorisation previously granted under Regulation (EC) No 1073/2009. 4. The authorising authority shall take a decision on the application no later than six months from the date of submission of the application by the road passenger transport operator. 5. Authorisation shall be granted unless: (a) the applicant is unable to provide the service which is the subject of the application with equipment directly available to the applicant; (b) the applicant has not complied with national or international legislation on road transport, and in particular the conditions and requirements relating to authorisations for international road passenger services, or has committed serious infringements of a Party's road transport legislation in particular with regard to the rules applicable to vehicles and driving and rest periods for drivers; (c) in the case of an application for renewal of authorisation, the conditions of authorisation have not been complied with; (d) a Party decides on the basis of a detailed analysis that the service concerned would seriously affect the viability of a comparable service covered by one or more public service contracts conforming to the Party's law on the direct sections concerned. In such a case, the Party shall set up criteria, on a non-discriminatory basis, for determining whether the service applied for would seriously affect the viability of the abovementioned comparable service and shall communicate them to the other Party referred to in paragraph 1; or (e) a Party decides on the basis of a detailed analysis that the principal purpose of the service is not to carry passengers between stops located in the territories of the Parties. In the event that an existing service seriously affects the viability of a comparable service covered by one or more public service contracts which conform to a Party's law on the direct sections concerned, due to exceptional reasons which could not have been foreseen at the time of granting the authorisation, a Party may, with the agreement of the other Party, suspend or withdraw the authorisation to run the international coach and bus service after having given six months' notice to the road passenger transport operator. The fact that a road passenger transport operator of a Party offers lower prices than those offered by other road passenger transport operators or the fact that the link in question is already operated by other road passenger transport operators shall not in itself constitute justification for rejecting the application. 6. Having completed the procedure laid down in paragraphs 1 to 5, the authorising authority shall grant the authorisation or formally refuse the application. Decisions rejecting an application shall state the reasons on which they are based. The Parties shall ensure that transport undertakings are given the opportunity to make representations in the event of their application being rejected. The authorising authority shall inform the competent authorities of the other Party of its decision and shall send them a copy of any authorisation. Article 480 Renewal and alteration of authorisation 1. Article 479 shall apply, mutatis mutandis, to applications for the renewal of authorisations or for alteration of the conditions under which the services subject to authorisation must be carried out. 2. Where the existing authorisation expires within six months from the date of entry into force of this Agreement, the period of time in which the competent authorities referred to in Article 479(2) shall notify the authorising authority of their agreement to, or comments on, the application in accordance with that Article, is two months. 3. In the event of a minor alteration to the operating conditions, in particular the adjustment of intervals, fares and timetables, the authorising authority needs only supply the competent authorities of the other Party with information relating to the alteration. Changing the timetables or intervals in a manner that affects the timing of controls at the borders between the Parties or at third country borders shall not be considered a minor alteration. Article 481 Lapse of an authorisation 1. Without prejudice to Article 479(3), an authorisation for a service referred to in Article 475 shall lapse at the end of its period of validity or three months after the authorising authority has received notice from its holder of his or her intention to withdraw the service. Such notice shall contain a proper statement of reasons. 2. Where demand for a service has ceased to exist, the period of notice provided for in paragraph 1 shall be one month. 3. The authorising authority shall inform the competent authorities of the other Party concerned that the authorisation has lapsed. 4. The holder of the authorisation shall notify users of the service concerned of its withdrawal one month in advance by means of appropriate publicity. Article 482 Obligations of transport operators 1. Save in the event of force majeure, the road passenger transport operator of a Party carrying out a service referred to in Article 475 shall launch the service without delay and, until the authorisation expires, take all measures to guarantee a transport service that fulfils the standards of continuity, regularity and capacity and complies with the conditions specified in accordance with Article 477(6) and Annex 32. 2. The road passenger transport operator of a Party shall display the route of the service, the bus stops, the timetable, the fares and the conditions of carriage in such a way as to ensure that such information is readily available to all users. 3. It shall be possible for the Parties to make changes to the operating conditions governing a service referred to in Article 475 by common agreement and in agreement with the holder of the authorisation. Article 483 Documents to be kept on the coach or bus 1. Without prejudice to Article 477(8), the authorisation or a certified true copy thereof to carry out services referred to in Article 475 and the operator's licence of the road passenger transport operator or a certified true copy thereof for the international carriage of passengers by road provided for according to national or Union law shall be kept on the coach or bus and shall be presented at the request of any authorised inspecting officer. 2. Without prejudice to paragraph 1 of this Article as well as to Article 477(8), in the case of a special regular service, the contract between the organiser and the road passenger transport operator or a copy thereof as well as a document evidencing that the passengers constitute a specific category to the exclusion of other passengers for the purposes of a special regular service shall also serve as control documents, shall be kept in the vehicle and shall be presented at the request of any authorised inspecting officer. 3. Road passenger transport operators carrying out occasional services under Article 475(6) and (7) shall carry a completed journey form, using the model set out in Annex 34. Books of journey forms shall be supplied by the competent authority of the territory in which the operator is registered, or by bodies appointed by the competent authority. Article 484 Road traffic rules Drivers of coaches and buses undertaking the transport of passengers under this Title shall, when in the territory of the other Party, comply with the national laws and regulations in force in that territory concerning road traffic. Article 485 Application The provisions of this Title shall cease to apply as of the date the Protocol to the Interbus Agreement regarding the international regular and special regular carriage of passengers by coach and bus enters into force for the United Kingdom, or six months following the entry into force of that Protocol for the Union, whichever is the earliest, except for the purpose of the operations under Article 475(2), (5), (6) and (7). Article 486 Obligations in other Titles Articles 135 and 137 are incorporated into and made part of this Title and apply to the treatment of transport operators undertaking journeys in accordance with Article 475. Article 487 Specialised Committee The Specialised Committee on Road Transport may amend Annexes 32, 33 and 34 to take into account regulatory developments. It may adopt measures regarding the implementation of this Title. HEADING FOUR SOCIAL SECURITY COORDINATION AND VISAS FOR SHORT-TERM VISITS TITLE I SOCIAL SECURITY COORDINATION Article 488 Overview Member States and the United Kingdom shall coordinate their social security systems in accordance with the Protocol on Social Security Coordination, in order to secure the social security entitlements of the persons covered therein. Article 489 Legally residing 1. The Protocol on Social Security Coordination applies to persons legally residing in a Member State or the United Kingdom. 2. Paragraph 1 of this Article shall not affect entitlements to cash benefits which relate to previous periods of legal residence of persons covered by Article SSC.2 of the Protocol on Social Security Coordination. Article 490 Cross-border situations 1. The Protocol on Social Security Coordination only applies to situations arising between one or more Member States and the United Kingdom. 2. The Protocol on Social Security Coordination shall not apply to persons whose situations are confined in all respects either to the United Kingdom, or to the Member States. Article 491 Immigration applications The Protocol on Social Security Coordination applies without prejudice to the right of a Member State or the United Kingdom to charge a health fee under national legislation in connection with an application for a permit to enter, to stay, to work, or to reside in that State. TITLE II VISAS FOR SHORT-TERM VISITS Article 492 Visas for short-term visits 1. The Parties note that on the date of entry into force of this Agreement both Parties provide for visa-free travel for short-term visits in respect of their nationals in accordance with their domestic law. Each Party shall notify the other of any intention to impose a visa requirement for short-term visits by nationals of the other Party in good time and, if possible, at least three months before such a requirement takes effect. 2. Subject to paragraph 3 of this Article and to Article 781, in the event that the United Kingdom decides to impose a visa requirement for short-term visits on nationals of a Member State, that requirement shall apply to the nationals of all Member States. 3. This Article is without prejudice to any arrangements made between the United Kingdom and Ireland concerning the Common Travel Area. HEADING FIVE FISHERIES CHAPTER 1 INITIAL PROVISIONS Article 493 Sovereign rights of coastal States exercised by the Parties The Parties affirm that sovereign rights of coastal States exercised by the Parties for the purpose of exploring, exploiting, conserving and managing the living resources in their waters should be conducted pursuant to and in accordance with the principles of international law, including the United Nations Convention on the Law of the Sea. Article 494 Objectives and principles 1. The Parties shall cooperate with a view to ensuring that fishing activities for shared stocks in their waters are environmentally sustainable in the long term and contribute to achieving economic and social benefits, while fully respecting the rights and obligations of independent coastal States as exercised by the Parties. 2. The Parties share the objective of exploiting shared stocks at rates intended to maintain and progressively restore populations of harvested species above biomass levels that can produce the maximum sustainable yield. 3. The Parties shall have regard to the following principles: (a) applying the precautionary approach to fisheries management; (b) promoting the long-term sustainability (environmental, social and economic) and optimum utilisation of shared stocks; (c) basing conservation and management decisions for fisheries on the best available scientific advice, principally that provided by the International Council for the Exploration of the Sea (ICES); (d) ensuring selectivity in fisheries to protect juvenile fish and spawning aggregations of fish, and to avoid and reduce unwanted bycatch; (e) taking due account of and minimising harmful impacts of fishing on the marine ecosystem and taking due account of the need to preserve marine biological diversity; (f) applying proportionate and non-discriminatory measures for the conservation of marine living resources and the management of fisheries resources, while preserving the regulatory autonomy of the Parties; (g) ensuring the collection and timely sharing of complete and accurate data relevant for the conservation of shared stocks and for the management of fisheries; (h) ensuring compliance with fisheries conservation and management measures, and combating illegal, unreported and unregulated fishing; and (i) ensuring the timely implementation of any agreed measures into the Parties' regulatory frameworks. Article 495 Definitions 1. For the purposes of this Heading, the following definitions apply: (a) "EEZ" (of a Party) means, in accordance with the United Nations Convention on the Law of the Sea: (i) in the case of the Union, the exclusive economic zones established by its Member States adjacent to their European territories; (ii) the exclusive economic zone established by the United Kingdom; (b) "precautionary approach to fisheries management" means an approach according to which the absence of adequate scientific information does not justify postponing or failing to take management measures to conserve target species, associated or dependent species and non-target species and their environment; (c) "shared stocks" means fish, including shellfish, of any kind that are found in the waters of the Parties, which includes molluscs and crustaceans; (d) "TAC" means the total allowable catch, which is the maximum quantity of a stock (or stocks) of a particular description that may be caught over a given period; (e) "non-quota stocks" means stocks which are not managed through TACs; (f) "territorial sea" (of a Party) means, in accordance with the United Nations Convention on the Law of the Sea: (i) in the case of the Union, by way of derogation from Article 774(1), the territorial sea established by its Member States adjacent to their European territories; (ii) the territorial sea established by the United Kingdom; (g) "waters" (of a Party) means: (i) in respect of the Union, by way of derogation from Article 774(1), the EEZs of the Member States and their territorial seas; (ii) in respect of the United Kingdom, its EEZ and its territorial sea, excluding for the purposes of Articles 500 and 501 and Annex 38 the territorial sea adjacent to the Bailiwick of Guernsey, the Bailiwick of Jersey and the Isle of Man; (h) "vessel" (of a Party) means: (i) in the case of the United Kingdom, a fishing vessel flying the flag of the United Kingdom, registered in the United Kingdom, the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man, and licensed by a United Kingdom fisheries administration; (ii) in the case of the Union, a fishing vessel flying the flag of a Member State and registered in the Union. CHAPTER 2 CONSERVATION AND SUSTAINABLE EXPLOITATION Article 496 Fisheries management 1. Each Party shall decide on any measures applicable to its waters in pursuit of the objectives set out in Article 494(1) and (2), and having regard to the principles referred to in Article 494(3). 2. A Party shall base the measures referred to in paragraph 1 on the best available scientific advice. A Party shall not apply the measures referred to in paragraph 1 to the vessels of the other Party in its waters unless it also applies the same measures to its own vessels. The second subparagraph is without prejudice to obligations of the Parties under the Port State Measures Agreement, the North East Atlantic Fisheries Commission Scheme of Control and Enforcement, the Northwest Atlantic Fisheries Organisation Conservation and Enforcement Measures, and Recommendation 18-09 by the International Commission for the Conservation of Atlantic Tunas on Port State Measures to Prevent, Deter and Eliminate Illegal, Unreported and Unregulated Fishing. The Specialised Committee on Fisheries may amend the list of pre-existing international obligations referred to in the third subparagraph. 3. Each Party shall notify the other Party of new measures as referred to in paragraph 1 that are likely to affect the vessels of the other Party before those measures are applied, allowing sufficient time for the other Party to provide comments or seek clarification. Article 497 Authorisations, compliance and enforcement 1. Where vessels have access to fish in the waters of the other Party pursuant to Article 500 and Article 502: (a) each Party shall communicate in sufficient time to the other Party a list of vessels for which it seeks to obtain authorisations or licences to fish; and (b) the other Party shall issue authorisations or licences to fish. 2. Each Party shall take all necessary measures to ensure compliance by its vessels with the rules applicable to those vessels in the other Party's waters, including authorisation or licence conditions. CHAPTER 3 ARRANGEMENTS ON ACCESS TO WATERS AND RESOURCES Article 498 Fishing opportunities 1. By 31 January of each year, the Parties shall cooperate to set the schedule for consultations with the aim of agreeing TACs for the stocks listed in Annex 35 for the following year or years. That schedule shall take into account other annual consultations among coastal States that affect either or both of the Parties. 2. The Parties shall hold consultations annually to agree, by 10 December of each year, the TACs for the following year for the stocks listed in Annex 35. This shall include an early exchange of views on priorities as soon as advice on the level of the TACs is received. The Parties shall agree those TACs: (a) on the basis of the best available scientific advice, as well as other relevant factors, including socio-economic aspects; and (b) in compliance with any applicable multi-year strategies for conservation and management agreed by the Parties. 3. The Parties' shares of the TACs for the stocks listed in Annex 35 shall be allocated between the Parties in accordance with the quota shares set out in that Annex. 4. Annual consultations may also cover, inter alia: (a) transfers of parts of one Party's shares of TACs to the other Party; (b) a list of stocks for which fishing is prohibited; (c) the determination of the TAC for any stock which is not listed in Annex 35 or Annex 36 and the Parties' respective shares of those stocks; (d) measures for fisheries management, including, where appropriate, fishing effort limits; (e) stocks of mutual interest to the Parties other than those listed in the Annexes to this Heading. 5. The Parties may hold consultations with the aim of agreeing amended TACs if either Party so requests. 6. A written record documenting the arrangements made between the Parties as a result of consultations under this Article shall be produced and signed by the heads of delegation of the Parties. 7. Each Party shall give sufficient notice to the other Party before setting or amending TACs for the stocks listed in Annex 37. 8. The Parties shall set up a mechanism for voluntary in-year transfers of fishing opportunities between the Parties, to take place each year. The Specialised Committee on Fisheries shall decide on the details of this mechanism. The Parties shall consider making transfers of fishing opportunities for stocks which are, or are projected to be, underfished available at market value through that mechanism. Article 499 Provisional TACs 1. If the Parties have not agreed a TAC for a stock listed in Annex 35 or tables A or B of Annex 36 by 10 December, they shall immediately resume consultations with the continued aim of agreeing the TAC. The Parties shall engage frequently with a view to exploring all possible options for reaching agreement in the shortest possible time. 2. If a stock listed in Annex 35 or in tables A and B of Annex 36 remains without an agreed TAC on 20 December, each Party shall set a provisional TAC corresponding to the level advised by ICES, applying from 1 January. 3. By way of derogation from paragraph 2, the TACs for special stocks shall be set in accordance with guidelines adopted under paragraph 5. 4. For the purposes of this Article, "special stocks" means: (a) stocks where the ICES advice is for a zero TAC; (b) stocks caught in a mixed fishery, if that stock or another stock in the same fishery is vulnerable; or (c) other stocks which the Parties consider require special treatment. 5. The Specialised Committee on Fisheries shall adopt guidelines by 1 July 2021 for the setting of provisional TACs for special stocks. 6. Each year when advice is received from ICES on TACs, the Parties shall discuss, as a priority, the special stocks and the application of any guidelines set under paragraph 5 to the setting of provisional TACs by each Party. 7. Each Party shall set its share for each of the provisional TACs, which shall not exceed its share as set out in the corresponding Annex. 8. The provisional TACs and shares referred to in paragraphs 2, 3 and 7 shall apply until agreement is reached under paragraph 1. 9. Each Party shall, immediately, notify the other Party of its provisional TACs under paragraphs 2 and 3 and its provisional share of each of those TACs under paragraph 7. Article 500 Access to waters 1. Provided that TACs have been agreed, each Party shall grant vessels of the other Party access to fish in its waters in the relevant ICES sub-areas that year. Access shall be granted at a level and on conditions determined in those annual consultations. 2. The Parties may agree, in annual consultations, further specific access conditions in relation to: (a) the fishing opportunities agreed; (b) any multi-year strategies for non-quota stocks developed under point (c) of Article 508(1); and (c) any technical and conservation measures agreed by the Parties, without prejudice to Article 496. 3. The Parties shall conduct the annual consultations, including on the level and conditions of access referred to in paragraph 1, in good faith and with the objective of ensuring a mutually satisfactory balance between the interests of both Parties. 4. In particular, the outcome of the annual consultations should normally result in each Party granting: (a) access to fish the stocks listed in Annex 35 and tables A, B and F of Annex 36 in each other's EEZ (or if access is granted under point (c), in EEZs and in the divisions mentioned in that point) at a level that is reasonably commensurate with the Parties' respective shares of the TACs; (b) access to fish non-quota stocks in each other's EEZ (or if access is granted under point (c), in EEZs and in the divisions mentioned in that point), at a level that at least equates to the average tonnage fished by that Party in the waters of the other Party during the period 2012-2016; and (c) access to the waters of the Parties between six and twelve nautical miles from the baselines in ICES divisions 4c and 7d-g for qualifying vessels to the extent that Union fishing vessels and United Kingdom fishing vessels had access to those waters on 31 December 2020. For the purposes of point (c), "qualifying vessel" means a vessel of a Party which fished in the zone mentioned in the previous sentence in four of the years between 2012 and 2016, or its direct replacement. Annual consultations referred to in point (c) may include appropriate financial commitments and quota transfers between the Parties. 5. During the application of a provisional TAC, and pending an agreed TAC, the Parties shall grant provisional access to fish in the relevant ICES sub-areas as follows: (a) for stocks listed in Annex 35 and non-quota stocks, from 1 January until 31 March at the levels provided for in points (a) and (b) of paragraph 4; (b) for stocks listed in Annex 36 from 1 January until 14 February at the levels provided for in point (a) of paragraph 4; and (c) in relation to access to fish in the six to twelve nautical miles zone, access in accordance with point (c) of paragraph 4 from 1 January to 31 January at a level equivalent to the average monthly tonnage fished in that zone in the previous three months. Such access, for each of the relevant stocks in points (a) and (b), shall be in proportion to the average percentage of a Party's share of the annual TAC which that Party's vessels fished in the other Party's waters in the relevant ICES sub-areas during the same period of the previous three calendar years. The same shall apply, mutatis mutandis, to access to fish non-quota stocks. By 15 January in relation to the situation in point (c) of this paragraph, by 31 January in respect of the stocks listed in Annex 36, and by 15 March in respect of all other stocks, each Party shall notify the other Party of the change in the level and conditions of access to waters that will apply as of 1 February in relation to the situation in point (c) of this paragraph, as of 15 February in respect of the stocks listed in Annex 36, and as of 1 April in respect of all other stocks for the relevant ICES sub-areas. 6. Without prejudice to Article 499(1) and (8), after the period of one month in relation to the situation in point (c) of paragraph 5 of this Article, one and a half months in respect of the stocks listed in Annex 36 and three months in respect of all other stocks, the Parties shall seek to agree further provisional access arrangements at the appropriate geographical level with the aim of minimising disruption to fishing activities. 7. In granting access under paragraph 1 of this Article, a Party may take into account compliance of individual or groups of vessels with the applicable rules in its waters during the preceding year, and measures taken by the other Party pursuant to Article 497(2) during the preceding year. 8. This Article shall apply subject to Annex 38. Article 501 Compensatory measures in case of withdrawal or reduction of access 1. Following a notification by a Party ("host Party") under Article 500(5), the other Party ("fishing Party") may take compensatory measures commensurate to the economic and societal impact of the change in the level and conditions of access to waters. Such impact shall be measured on the basis of reliable evidence and not merely on conjecture and remote possibility. Giving priority to those compensatory measures which will least disturb the functioning of this Agreement, the fishing Party may suspend, in whole or in part, access to its waters and the preferential tariff treatment granted to fishery products under Article 21. 2. A compensatory measure referred to in paragraph 1 of this Article may take effect at the earliest seven days after the fishing Party has given notice to the host Party of the intended suspension under paragraph 1 of this Article and, in any case, not earlier than 1 February in relation to the situation in point (c) of Article 500(5), 15 February in respect of Annex 36 and 1 April in respect of other stocks. The Parties shall consult within the Specialised Committee with a view to reaching a mutually agreeable solution. That notification shall identify: (a) the date upon which the fishing Party intends to suspend; and (b) the obligations to be suspended and the level of the intended suspension. 3. After the notification of the compensatory measures in accordance with paragraph 2 of this Article, the host Party may request the establishment of an arbitration tribunal pursuant to Article 739, without having recourse to consultations in accordance with Article 738. The arbitration tribunal may only review the conformity of the compensatory measures with paragraph 1 of this Article. The arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. 4. When the conditions for taking compensatory measures referred to in paragraph 1 are no longer met, such measures shall be withdrawn immediately. 5. Following a finding against the fishing Party in the procedure referred to in paragraph 3 of this Article, the host Party may request the arbitration tribunal, within 30 days from its ruling, to determine a level of suspension of obligations under this Agreement not exceeding the level equivalent to the nullification or impairment caused by the application of the compensatory measures, if it finds that the inconsistency of the compensatory measures with paragraph 1 of this Article is significant. The request shall propose a level of suspension in accordance with the principles set out in paragraph 1 of this Article and any relevant principles set out in Article 761. The host Party may apply the level of suspension of obligations under this Agreement in accordance with the level of suspension determined by the arbitration tribunal, no sooner than 15 days following such ruling. 6. A Party shall not invoke the WTO Agreement or any other international agreement to preclude the other Party from suspending obligations under this Article. Article 502 Specific access arrangements relating to the Bailiwick of Guernsey, the Bailiwick of Jersey and the Isle of Man 1. By way of derogation from Article 500(1) and (3) to (7), Article 501 and Annex 38, each Party shall grant vessels of the other Party access to fish in its waters reflecting the actual extent and nature of fishing activity that it can be demonstrated was carried out during the period beginning on 1 February 2017 and ending on 31 January 2020 by qualifying vessels of the other Party in the waters and under any treaty arrangements that existed on 31 January 2020. 2. For the purposes of this Article and, in so far as the other Articles in this Heading apply in relation to the arrangements for access established under this Article: (a) "qualifying vessel" means, in respect of fishing activity carried out in waters adjacent to the Bailiwick of Guernsey, the Bailiwick of Jersey, the Isle of Man or a Member State, any vessel which fished in the territorial sea adjacent to that territory or that Member State on more than 10 days in any of the three 12 month periods ending on 31 January, or between 1 February 2017 and 31 January 2020; (b) "vessel" (of a Party)" means, in respect of the United Kingdom, a fishing vessel flying the flag of the United Kingdom and registered in the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man, and licensed by a United Kingdom fisheries administration; (c) "waters" (of a Party) means: (i) in respect of the Union, the territorial sea adjacent to a Member State; and (ii) in respect of the United Kingdom, the territorial sea adjacent to each of the Bailiwick of Guernsey, the Bailiwick of Jersey and the Isle of Man. 3. At the request of either Party, the Partnership Council shall decide, within 90 days of the entry into force of this Agreement, that this Article, Article 503 and any other provisions of this Heading in so far as they relate to the arrangements provided for in those Articles as well as Article 520(3) to (8) shall cease to apply in respect of one or more of the Bailiwick of Guernsey, the Bailiwick of Jersey and the Isle of Man, following 30 days from this decision. 4. The Partnership Council may decide to amend this Article, Article 503 and any other provisions of this Heading in so far as they relate to the arrangements provided for in those Articles. Article 503 Notification periods relating to the importation and direct landing of fishery products 1. The Union shall apply the following notification periods to fishery products caught by vessels flying the flag of the United Kingdom and registered in the Bailiwick of Guernsey or the Bailiwick of Jersey in the territorial sea adjacent to those territories or in the territorial sea adjacent to a Member State: (a) prior notification of between three and five hours before landing fresh fishery products into the Union's territory; (b) prior notification of between one and three hours of the validated catch certificate for the direct movement of consignments of fishery products by sea before the estimated time of arrival at the place of entry into the Union's territory. 2. For the purposes of this Article only, "fishery products" means all species of marine fish, molluscs and crustaceans. Article 504 Alignment of management areas 1. By 1 July 2021, the Parties shall request advice from ICES on the alignment of the management areas and the assessment units used by ICES for the stocks marked with an asterisk in Annex 35. 2. Within six months of receipt of the advice referred to in paragraph 1, the Parties shall jointly review that advice and shall jointly consider adjustments to the management areas of the stocks concerned, with a view to agreeing consequential changes to the list of stocks and shares set out in Annex 35. Article 505 Shares of TACs for certain other stocks 1. The Parties' respective shares of the TACs for certain other stocks are set out in Annex 36. 2. Each Party shall notify the relevant States and international organisations of its shares in accordance with the sharing arrangement set out in tables A to D of Annex 36. 3. Any subsequent changes to those shares in tables C and D of Annex 36 are a matter for the relevant multilateral fora. 4. Without prejudice to the powers of the Partnership Council in Article 508(3), any subsequent changes to the shares in tables A and B of Annex 36 after 30 June 2026 are a matter for the relevant multilateral fora. 5. Both Parties shall approach the management of those stocks in tables A to D of Annex 36 in accordance with the objectives and principles set out in Article 494. CHAPTER 4 ARRANGEMENTS ON GOVERNANCE Article 506 Remedial measures and dispute resolution 1. In relation to an alleged failure by a Party (the "respondent Party") to comply with this Heading (other than in relation to alleged failures dealt with under paragraph 2), the other Party (the "complaining Party") may, after giving notice to the respondent Party: (a) suspend, in whole or in part, access to its waters and the preferential tariff treatment granted to fishery products under Article 21; and (b) if it considers that the suspension referred to in point (a) of this paragraph is not commensurate to the economic and societal impact of the alleged failure, it may suspend, in whole or in part, the preferential tariff treatment of other goods under Article 21; and (c) if it considers that the suspension referred to in points (a) and (b) of this paragraph is not commensurate to the economic and societal impact of the alleged failure, it may suspend, in whole or in part, obligations under Heading One of this Part with the exception of Title XI. If Heading One of this Part is suspended in whole, Heading Three of this part is also suspended. 2. In relation to an alleged failure by a Party (the "respondent Party") to comply with Article 502, 503 or any other provision of this Heading in so far as it relates to the arrangements provided for in those Articles, the other Party (the "complaining Party"), after giving notice to the respondent Party: (a) may suspend, in whole or in part, access to its waters within the meaning of Article 502; (b) if it considers that the suspension referred to in point (a) of this paragraph is not commensurate to the economic and societal impact of the alleged failure, may suspend, in whole or in part, the preferential tariff treatment granted to fishery products under Article 21; (c) if it considers that the suspension referred to in points (a) and (b) of this paragraph is not commensurate to the economic and societal impact of the alleged failure, may suspend, in whole or in part, the preferential tariff treatment of other goods under Article 21. By way of derogation from paragraph 1 of this Article, remedial measures affecting the arrangements established under Article 502, Article 503 or any other provision of this Heading in so far as it relates to the arrangements provided for in those Articles may not be taken as a result of an alleged failure by a Party to comply with provisions of this Heading unconnected to those arrangements. 3. Measures referred to in paragraphs 1 and 2 shall be proportionate to the alleged failure by the respondent Party and the economic and societal impact thereof. 4. A measure referred to in paragraphs 1 and 2 may take effect at the earliest seven days after the complaining Party has given the respondent Party notice of the proposed suspension. The Parties shall consult within the Specialised Committee on Fisheries with a view to reaching a mutually agreeable solution. That notification shall identify: (a) the way in which the complaining Party considers that the respondent Party has failed to comply; (b) the date upon which the complaining Party intends to suspend; and (c) the level of intended suspension. 5. The complaining Party must, within 14 days of the notification referred to in paragraph 4 of this Article, challenge the alleged failure by the respondent Party to comply with this Heading, as referred to in paragraphs 1 and 2 of this Article, by requesting the establishment of an arbitration tribunal under Article 739. Recourse to arbitration under this Article shall be made without having prior recourse to consultations under Article 738. An arbitration tribunal shall treat the issue as a case of urgency for the purpose of Article 744. 6. The suspension shall cease to apply when: (a) the complaining Party is satisfied that the respondent Party is complying with its relevant obligations under this Heading; or (b) the arbitration tribunal has decided that the respondent Party has not failed to comply with its relevant obligations under this Heading. 7. Following a finding against the complaining Party in the procedure referred to in paragraph 5 of this Article, the respondent Party may request the arbitration tribunal, within 30 days from its ruling, to determine a level of suspension of obligations under this Agreement not exceeding the level equivalent to the nullification or impairment caused by the application of the remedial measures, if it finds that the inconsistency of the remedial measures with paragraph 1 or 2 of this Article is significant. The request shall propose a level of suspension in accordance with paragraph 1 or 2 of this Article and any relevant principles set out in Article 761. The respondent Party may apply the level of suspension of obligations under this Agreement in accordance with the level of suspension determined by the arbitration tribunal, no sooner than 15 days following such ruling. 8. A Party shall not invoke the WTO Agreement or any other international agreement to preclude the other Party from suspending obligations under this Article. Article 507 Data sharing The Parties shall share such information as is necessary to support the implementation of this Heading, subject to each Party's laws. Article 508 Specialised Committee on Fisheries 1. The Specialised Committee on Fisheries may in particular: (a) provide a forum for discussion and cooperation in relation to sustainable fisheries management; (b) consider the development of multi-year strategies for conservation and management as the basis for the setting of TACs and other management measures; (c) develop multi-year strategies for the conservation and management of non-quota stocks as referred to in point (b) of Article 500(2); (d) consider measures for fisheries management and conservation, including emergency measures and measures to ensure selectivity of fishing; (e) consider approaches to the collection of data for science and fisheries management purposes, the sharing of such data (including information relevant to monitoring, controlling and enforcing compliance), and the consultation of scientific bodies regarding the best available scientific advice; (f) consider measures to ensure compliance with the applicable rules, including joint control, monitoring and surveillance programmes and the exchange of data to facilitate monitoring uptake of fishing opportunities and control and enforcement; (g) develop the guidelines for setting the TACs referred to in Article 499(5); (h) make preparations for annual consultations; (i) consider matters relating to the designation of ports for landings, including the facilitation of the timely notification by the Parties of such designations and of any changes to those designations; (j) establish timelines for the notification of measures referred to in Article 496(3), the communication of the lists of vessels referred to in Article 497(1) and the notice referred to in Article 498(7); (k) provide a forum for consultations under Article 501(2) and Article 506(4); (l) develop guidelines to support the practical application of Article 500; (m) develop a mechanism for voluntary in-year transfers of fishing opportunities between the Parties, as referred to in Article 498(8); and (n) consider the application and implementation of Article 502 and Article 503. 2. The Specialised Committee on Fisheries may adopt measures, including decisions and recommendations: (a) recording matters agreed by the Parties following consultations under Article 498; (b) in relation to any of the matters referred to in points (b), (c), (d), (e), (f), (g), (i), (j), (l), (m) and (n) of paragraph 1 of this Article; (c) amending the list of pre-existing international obligations referred to in Article 496(2); (d) in relation to any other aspect of cooperation on sustainable fisheries management under this Heading; and (e) on the modalities of a review under Article 510. 3. The Partnership Council shall have the power to amend Annexes 35, 36 and 37. Article 509 Termination 1. Without prejudice to Article 779 or Article 521, each Party may at any moment terminate this Heading, by written notification through diplomatic channels. In that event, Heading One, Heading Two, Heading Three and this Heading shall cease to be in force on the first day of the ninth month following the date of notification. 2. In the event of termination of this Heading pursuant to paragraph 1 of this Article, Article 779 or Article 521, obligations entered into by the Parties under this Heading for the year ongoing at the time when this Heading ceases to be in force shall continue to apply until the end of the year. 3. Notwithstanding paragraph 1 of this Article, Heading Two may remain in force, if the Parties agree to integrate the relevant parts of Title XI of Heading One. 4. By way of derogation from paragraphs 1 to 3 of this Article and without prejudice to Article 779 or Article 521: (a) unless agreed otherwise between the Parties, Article 502, Article 503 and any other provision of this Heading in so far as it relates to the arrangements provided for in those Articles, shall remain in force until: (i) they are terminated by either Party giving to the other Party three years' written notice of termination; or (ii) if earlier, the date on which Article 520(3) to (5) cease to be in force; (b) for the purposes of point (a)(i), notice of termination may be given in respect of one or more of the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man and Article 502, Article 503 and any other provision of this Heading in so far as it relates to the arrangements provided for in those Articles, shall continue to be in force for those territories in respect of which a notice of termination has not been given; and (c) for the purposes of point (a)(ii), if Article 520(3) to (5) cease to be in force in relation to one or more (but not all) of the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man, Article 502, Article 503 and any other provision of this Heading in so far as it relates to the arrangements provided for in those Articles, shall continue to be in force for those territories in respect of which Article 520(3) to (5) remain in force. Article 510 Review clause 1. The Parties, within the Partnership Council, shall jointly review the implementation of this Heading four years after the end of the adjustment period referred to in the Article 1 of Annex 38 with the aim of considering whether arrangements, including in relation to access to waters, can be further codified and strengthened. 2. Such a review may be repeated at subsequent intervals of four years after the conclusion of the first review. 3. The Parties shall decide, in advance, on the modalities of the review through the Specialised Committee on Fisheries. 4. The review shall, in particular, allow for an evaluation, in relation to the previous years, of: (a) the provisions for access to each other's waters under Article 500; (b) the shares of TACs set out in Annexes 35, 36 and 37; (c) the number and extent of transfers as part of annual consultations under Article 498(4) and any transfers under Article 498(8); (d) the fluctuations in annual TACs; (e) compliance by both Parties with the provisions of this Heading and the compliance by vessels of each Party with the rules applicable to those vessels when in the other Party's waters; (f) the nature and extent of cooperation under this Heading; and (g) any other element the Parties decide, in advance, through the Specialised Committee on Fisheries. Article 511 Relationship with other agreements 1. Subject to paragraph 2, this Heading shall be without prejudice to other existing agreements concerning fishing by vessels of a Party within the area of jurisdiction of the other Party. 2. This Heading shall supersede and replace any existing agreements or arrangements with respect to fishing by Union fishing vessels in the territorial sea adjacent to the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man and with respect to fishing by United Kingdom fishing vessels registered in the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man in the territorial sea adjacent to a Member State. However, if the Partnership Council takes a decision in accordance with Article 502 for this Agreement to cease to apply in respect of the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man, the relevant agreements or arrangements shall not be superseded and replaced in respect of the territory or territories for which such a decision has been taken. HEADING SIX OTHER PROVISIONS Article 512 Definitions Unless otherwise specified, for the purposes of Part Two, the Protocol on mutual administrative assistance in customs matters and the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties, the following definitions apply: (a) "customs authority" means: (i) with respect to the Union, the services of the European Commission responsible for customs matters or, as appropriate, the customs administrations and any other authorities empowered in the Member States of the Union to apply and enforce customs legislation, and (ii) with respect to the United Kingdom, Her Majesty's Revenue and Customs and any other authority responsible for customs matters; (b) "customs duty" means any duty or charge of any kind imposed on, or in connection with, the importation of a good but does not include: (i) a charge equivalent to an internal tax imposed consistently with Article 19; (ii) an anti-dumping, special safeguard, countervailing or safeguard duty applied consistently with GATT 1994, the Anti-dumping Agreement, the Agreement on Agriculture, the Agreement on Subsidies and Countervailing Measures or the Agreement on Safeguards, as appropriate; or (iii) a fee or other charge imposed on or in connection with importation that is limited in amount to the approximate cost of the services rendered; (c) "CPC" means the Provisional Central Product Classification (Statistical Papers Series M No.77, Department of International Economic and Social Affairs, Statistical Office of the United Nations, New York, 1991); (d) "existing" means in effect on the date of entry into force of this Agreement; (e) "goods of a Party" means domestic products within the meaning of GATT 1994, and includes originating goods of that Party; (f) "Harmonised System" or "HS" means the Harmonised Commodity Description and Coding System, including all legal notes and amendments thereto developed by the World Customs Organization; (g) "heading" means the first four digits in the tariff classification number under the Harmonised System; (h) "legal person" means any legal entity duly constituted or otherwise organised under applicable law, whether for profit or otherwise, and whether privately-owned or governmentally-owned, including any corporation, trust, partnership, joint venture, sole proprietorship or association; (i) "measure" means any measure by a Party, whether in the form of a law, regulation, rule, procedure, decision, administrative action, requirement or practice, or any other form; (71) (j) "measures of a Party" means any measures adopted or maintained by: (i) central, regional or local governments or authorities; and (ii) non-governmental bodies in the exercise of powers delegated by central, regional or local governments or authorities; "measures of a Party" includes measures adopted or maintained by entities listed under sub-paragraphs (i) and (ii) by instructing, directing or controlling, either directly or indirectly, the conduct of other entities with regard to those measures. (k) "natural person of a Party" means (72): (i) for the European Union, a national of a Member State according to its law; (73) and (ii) for the United Kingdom, a British citizen; (l) "person" means a natural person or a legal person; (m) "sanitary or phytosanitary measure" means any measure referred to in paragraph 1 of Annex A to the SPS Agreement; (n) "third country" means a country or territory outside the territorial scope of application of this Agreement; and (o) "WTO" means the World Trade Organization. Article 513 WTO Agreements For the purposes of this Agreement, the WTO Agreements are referred to as follows: (a) "Agreement on Agriculture" means the Agreement on Agriculture, contained in Annex 1A to the WTO Agreement; (b) "Anti-dumping Agreement" means the Agreement on Implementation of Article VI of the General Agreement on Tariffs and Trade 1994; (c) "GATS" means the General Agreement on Trade in Services, contained in Annex 1B to the WTO Agreement; (d) "GATT 1994" means the General Agreement on Tariffs and Trade 1994, contained in Annex 1A to the WTO Agreement; (e) "GPA" means the Agreement on Government Procurement in Annex 4 to the WTO Agreement (74); (f) "Safeguards Agreement" means the Agreement on Safeguards, contained in Annex 1A to the WTO Agreement; (g) "SCM Agreement" means the Agreement on Subsidies and Countervailing Measures, contained in Annex 1A to the WTO Agreement; (h) "SPS Agreement" means the Agreement on the Application of Sanitary and Phytosanitary Measures, contained in Annex 1A to the WTO Agreement; (i) "TBT Agreement" means the Agreement on Technical Barriers to Trade, contained in Annex 1 to the WTO Agreement; (j) "TRIPS Agreement" means the Agreement on Trade-Related Aspects of Intellectual Property Rights, contained in Annex 1C to the WTO Agreement; and (k) "WTO Agreement" means the Marrakesh Agreement Establishing the World Trade Organization, done at Marrakesh on 15 April 1994. Article 514 Establishment of a free trade area The Parties hereby establish a free trade area, in conformity with Article XXIV of GATT 1994 and Article V of GATS. Article 515 Relation to the WTO Agreement The Parties affirm their rights and obligations with respect to each other under the WTO Agreement and other agreements to which they are party. Nothing in this Agreement shall be construed as requiring either Party to act in a manner inconsistent with its obligations under the WTO Agreement. Article 516 WTO case-law The interpretation and application of the provisions of this Part shall take into account relevant interpretations in reports of WTO panels and of the Appellate Body adopted by the Dispute Settlement Body of the WTO as well as in arbitration awards under the Dispute Settlement Understanding. Article 517 Fulfilment of obligations Each Party shall adopt any general or specific measures required to fulfil their obligations under this Part, including those required to ensure its observance by central, regional or local governments and authorities, as well as non-governmental bodies in the exercise of powers delegated to them. Article 518 References to laws and other Agreements 1. Unless otherwise specified, where reference is made in this Part to laws and regulations of a Party, those laws and regulations shall be understood to include amendments thereto. 2. Unless otherwise specified, where international agreements are referred to or incorporated into this Part, in whole or in part, they shall be understood to include amendments thereto or their successor agreements entering into force for both Parties on or after the date of signature of this Agreement. If any matter arises regarding the implementation or application of the provisions of this Part as a result of such amendments or successor agreements, the Parties may, on request of either Party, consult with each other with a view to finding a mutually satisfactory solution to this matter, as necessary. Article 519 Tasks of the Partnership Council in Part Two The Partnership Council may: (a) adopt decisions to amend: (i) Chapter 2 of Title I of Heading one of Part two and its Annexes, in accordance with Article 68; (ii) the arrangements set out in Annexes 16 and 17, in accordance with Article 96(8); (iii) Appendices 15-A and 15-B, in accordance with Article 2(3) of Annex 15; (iv) Appendix 15-C, in accordance with Article 3(3) of Annex 15; (v) Appendices 14-A, 14-B, 14-C and 14-D, in accordance with Article 1 of Annex 14; (vi) Appendices 12-A, 12-B and 12-C, in accordance with Article 11 of Annex 12; (vii) the Annex on Authorised Economic Operators, the Protocol on mutual administrative assistance in customs matters, the Protocol on combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties, and the list of goods set out in Article 117(2), in accordance with Article 122; (viii) the relevant Sub-section under Section B of Annex 25, in accordance with Article 293; (ix) Annexes 26, 27 and 28, in accordance with Article 329; (x) Article 364(4) in accordance with that paragraph, the third sentence of Article 365(2) in accordance with the fourth sentence of that paragraph, Article 365(3) in accordance with that paragraph, Article 367 in accordance with paragraph 1 of that Article and Article 373 in accordance with paragraph 7 of that Article; (xi) Article 502, Article 503 and any other provision of Heading Five, in accordance with Article 502(4); (xii) Annexes 35, 36 and 37, in accordance with Article 508(3); (xiii) any other provision, protocol, appendix or annex, for which the possibility of such decision is explicitly foreseen in this Part; (b) adopt decisions to issue interpretations of the provisions of this Part. Article 520 Geographical application 1. The provisions of this Agreement concerning the tariff treatment of goods, including rules of origin and the temporary suspension of this treatment shall also apply, with respect to the Union, to those areas of the customs territory of the Union, as defined by Article 4 of Regulation (EU) No 952/2013 of the European Parliament and of the Council (75), which are not covered by point (a) of Article 774(1). 2. Without prejudice to Article 774(2), (3) and (4), the rights and obligations of the Parties under this Part shall also apply with regard to the areas beyond each Party's territorial sea, including the sea-bed and subsoil thereof, over which that Party exercises sovereign rights or jurisdiction in accordance with international law including the United Nations Convention on the Law of the Sea and its laws and regulations which are consistent with international law (76). 3. Subject to the exceptions contained in paragraph 4 of this Article, Chapters 1, 2 and 5 of Title I of Heading One and the Protocols and Annexes to those Chapters shall also apply, with respect to the United Kingdom, to the territories referred to in Article 774(2). For that purpose, the territories referred to in Article 774(2) shall be considered as being part of the customs territory of the United Kingdom. The customs authorities of the territories referred to in Article 774(2) shall be responsible for the application and implementation of these Chapters, and the Protocols and Annexes to these Chapters, in their respective territories. References to "customs authority" in those provisions shall be read accordingly. However, requests and communications made under these Chapters, and the Protocols and Annexes to these Chapters, shall be administered by the customs authority of the United Kingdom. 4. Article 110, Annex 18 and the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties shall not apply to the Bailiwick of Jersey or the Bailiwick of Guernsey. 5. Chapters 3 and 4 of Title I of Heading One and the Annexes to those Chapters shall also apply, with respect to the United Kingdom, to the territories referred to in Article 774(2). The authorities of the territories referred to in Article 774(2) shall be responsible for the application and implementation of these Chapters, and the Annexes to these Chapters, in their respective territories and relevant references shall be read accordingly. However, requests and communications made under these Chapters, and the Annexes to these Chapters, shall be administered by the authorities of the United Kingdom. 6. Without prejudice to Article 779 and Article 521 and unless agreed otherwise between the Parties, paragraphs 3 to 5 of this Article shall remain in force until the earlier of: (a) expiry of a period of three years following written notice of termination to the other Party; or (b) the date on which Article 502, Article 503 and any other provision of Heading Five in so far as it relates to the arrangements provided for in those Articles cease to be in force. 7. For the purposes of point (a) of paragraph 6, notice of termination may be given in respect of one or more of the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man and paragraphs 3 to 5 of this Article shall continue in force for those territories in respect of which a notice of termination has not been given. 8. For the purposes of point (b) of paragraph 6, if Article 502, Article 503 and any other provision of Heading Five in so far as it relates to the arrangements provided for in those Articles cease to be in force in relation to one or more (but not all) of the Bailiwick of Guernsey, the Bailiwick of Jersey or the Isle of Man, paragraphs 3 to 5 of this Article shall continue to be in force for those territories in respect of which Article 502, Article 503 and any other provision of Heading Five in so far as it relates to the arrangements provided for in those Articles remain in force. Article 521 Termination of Part Two Without prejudice to Article 779, each Party may at any moment terminate this Part by written notification through diplomatic channels. In that event, this Part shall cease to be in force on the first day of the ninth month following the date of notification. Heading Four and the Protocol on Social Security Coordination shall not be terminated pursuant to this Article. PART THREE LAW ENFORCEMENT AND JUDICIAL COOPERATION IN CRIMINAL MATTERS TITLE I GENERAL PROVISIONS Article 522 Objective 1. The objective of this Part is to provide for law enforcement and judicial cooperation between the Member States and Union institutions, bodies, offices and agencies, on the one side, and the United Kingdom, on the other side, in relation to the prevention, investigation, detection and prosecution of criminal offences and the prevention of and fight against money laundering and financing of terrorism. 2. This Part only applies to law enforcement and judicial cooperation in criminal matters taking place exclusively between the United Kingdom, on the one side, and the Union and the Member States, on the other side. It does not apply to situations arising between the Member States, or between Member States and Union institutions, bodies, offices and agencies, nor does it apply to the activities of authorities with responsibilities for safeguarding national security when acting in that field. Article 523 Definitions For the purposes of this Part, the following definitions apply: (a) "third country" means a country other than a Member State or the United Kingdom; (b) "special categories of personal data" means personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, genetic data, biometric data processed for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person's sex life or sexual orientation; (c) "genetic data" means all personal data relating to the genetic characteristics of an individual that have been inherited or acquired, which give unique information about the physiology or the health of that individual, resulting in particular from an analysis of a biological sample from the individual in question; (d) "biometric data" means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person which allow or confirm the unique identification of that natural person, such as facial images or dactyloscopic data; (e) "processing" means any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction; (f) "personal data breach" means a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed; (g) "filing system" means any structured set of personal data which are accessible according to specific criteria, whether centralised, decentralised or dispersed on a functional or geographical basis; (h) "Specialised Committee on Law Enforcement and Judicial Cooperation" means the Committee by that name established by Article 8. Article 524 Protection of human rights and fundamental freedoms 1. The cooperation provided for in this Part is based on the Parties' and Member States' long-standing respect for democracy, the rule of law and the protection of fundamental rights and freedoms of individuals, including as set out in the Universal Declaration of Human Rights and in the European Convention on Human Rights, and on the importance of giving effect to the rights and freedoms in that Convention domestically. 2. Nothing in this Part modifies the obligation to respect fundamental rights and legal principles as reflected, in particular, in the European Convention on Human Rights and, in the case of the Union and its Member States, in the Charter of Fundamental Rights of the European Union. Article 525 Protection of personal data 1. The cooperation provided for in this Part is based on the Parties' long-standing commitment to ensuring a high level of protection of personal data. 2. To reflect that high level of protection, the Parties shall ensure that personal data processed under this Part is subject to effective safeguards in the Parties' respective data protection regimes, including that: (a) personal data is processed lawfully and fairly, in compliance with the principles of data minimisation, purpose limitation, accuracy and storage limitation; (b) processing of special categories of personal data is only permitted to the extent necessary and subject to appropriate safeguards adapted to the specific risks of the processing; (c) a level of security appropriate to the risk of the processing is ensured through relevant technical and organisational measures, in particular as regards the processing of special categories of personal data; (d) data subjects are granted enforceable rights of access, rectification and erasure, subject to possible restrictions provided for by law which constitute necessary and proportionate measures in a democratic society to protect important objectives of public interest; (e) in the event of a data breach creating a risk to the rights and freedoms of natural persons, the competent supervisory authority is notified without undue delay of the breach; where the breach is likely to result in a high risk to the rights and freedoms of natural persons, the data subjects are also notified, subject to possible restrictions provided for by law which constitute necessary and proportionate measures in a democratic society to protect important objectives of public interest; (f) onward transfers to a third country are allowed only subject to conditions and safeguards appropriate to the transfer ensuring that the level of protection is not undermined; (g) the supervision of compliance with data protection safeguards and the enforcement of data protection safeguards are ensured by independent authorities; and (h) data subjects are granted enforceable rights to effective administrative and judicial redress in the event that data protection safeguards have been violated. 3. The United Kingdom, on the one side, and the Union, also on behalf of any of its Member States, on the other side, shall notify the Specialised Committee on Law Enforcement and Judicial Cooperation of the supervisory authorities responsible for overseeing the implementation of, and ensuring compliance with, data protection rules applicable to cooperation under this Part. The supervisory authorities shall cooperate to ensure compliance with this Part. 4. The provisions on the protection of personal data set out in this Part apply to the processing of personal data wholly or partly by automated means, and to the processing other than by automated means of personal data which form part of a filing system or are intended to form part of a filing system. 5. This Article is without prejudice to the application of any specific provisions in this Part relating to the processing of personal data. Article 526 Scope of cooperation where a Member State no longer participates in analogous measures under Union law 1. This Article applies if a Member State ceases to participate in, or enjoy rights under, provisions of Union law relating to law enforcement and judicial cooperation in criminal matters analogous to any of the relevant provisions of this Part. 2. The United Kingdom may notify the Union in writing of its intention to cease to operate the relevant provisions of this Part in relation to that Member State. 3. A notification given under paragraph 2 takes effect on the date specified therein, which shall be no earlier than the date on which the Member State ceases to participate in, or to enjoy rights under, the provisions of Union law referred to in paragraph 1. 4. If the United Kingdom gives notification under this Article of its intention to cease to apply the relevant provisions of this Part, the Specialised Committee on Law Enforcement and Judicial Cooperation shall meet to decide what measures are needed to ensure that any cooperation initiated under this Part that is affected by the cessation is concluded in an appropriate manner. In any event, with regard to all personal data obtained through cooperation under the relevant provisions of this Part before they cease to be applied, the Parties shall ensure that the level of protection under which the personal data were transferred is maintained after the cessation takes effect. 5. The Union shall notify the United Kingdom in writing, through diplomatic channels, of the date on which the Member State is to resume its participation in, or the enjoyment of rights under, the provisions of Union law in question. The application of the relevant provisions of this Part shall be reinstated on that date or, if later, on the first day of the month following the day on which that notification has been given. 6. To facilitate the application of this Article, the Union shall inform the United Kingdom when a Member State ceases to participate in, or enjoy rights under, provisions of Union law relating to law enforcement and judicial cooperation in criminal matters analogous to the relevant provisions of this Part. TITLE II EXCHANGES OF DNA, FINGERPRINTS AND VEHICLE REGISTRATION DATA Article 527 Objective The objective of this Title is to establish reciprocal cooperation between the competent law enforcement authorities of the United Kingdom, on the one side, and the Member States, on the other side, on the automated transfer of DNA profiles, dactyloscopic data and certain domestic vehicle registration data. Article 528 Definitions For the purposes of this Title, the following definitions apply: (a) "competent law enforcement authority" means a domestic police, customs or other authority that is authorised by domestic law to detect, prevent and investigate offences or criminal activities and to exercise authority and take coercive measures in the context of such activities; agencies, bodies or other units dealing especially with national security issues are not competent law enforcement authorities for the purposes of this Title; (b) "search" and "comparison", as referred to in Articles 530, 531, 534 and 539 mean the procedures by which it is established whether there is a match between, respectively, DNA data or dactyloscopic data which have been communicated by one State and DNA data or dactyloscopic data stored in the databases of one, several, or all of the other States; (c) "automated searching", as referred to in Article 537, means an online access procedure for consulting the databases of one, several, or all of the other States; (d) "non-coding part of DNA" means chromosome regions not genetically expressed, i.e. not known to provide for any functional properties of an organism; (e) "DNA profile" means a letter or numeric code which represents a set of identification characteristics of the non-coding part of an analysed human DNA sample, i.e. the particular molecular structure at the various DNA locations (loci); (f) "DNA reference data" means DNA profile and reference number; DNA reference data shall only include DNA profiles established from the non-coding part of DNA and a reference number; DNA reference data shall not contain any data from which the data subject can be directly identified; DNA reference data which is not attributed to any natural person (unidentified DNA profiles) shall be recognisable as such; (g) "reference DNA profile" means the DNA profile of an identified person; (h) "unidentified DNA profile" means the DNA profile obtained from traces collected during the investigation of criminal offences and belonging to a person not yet identified; (i) "note" means a State's marking on a DNA profile in its domestic database indicating that there has already been a match for that DNA profile on another State's search or comparison; (j) "dactyloscopic data" means fingerprint images, images of fingerprint latents, palm prints, palm print latents and templates of such images (coded minutiae), when they are stored and dealt with in an automated database; (k) "dactyloscopic reference data" means dactyloscopic data and reference number; dactyloscopic reference data shall not contain any data from which the data subject can be directly identified; dactyloscopic reference data which is not attributed to any natural person (unidentified dactyloscopic data) shall be recognisable as such; (l) "vehicle registration data" means the data-set as specified in Chapter 3 of Annex 39; (m) "individual case", as referred to in Article 530(1), second sentence, Article 534(1), second sentence and Article 537(1), means a single investigation or prosecution file; if such a file contains more than one DNA profile, or one piece of dactyloscopic data or vehicle registration data, they may be transmitted together as one request; (n) "laboratory activity" means any measure taken in a laboratory when locating and recovering traces on items, as well as developing, analysing and interpreting forensic evidence regarding DNA profiles and dactyloscopic data, with a view to providing expert opinions or exchanging forensic evidence; (o) "results of laboratory activities" means any analytical outputs and directly associated interpretation; (p) "forensic service provider" means any organisation, public or private, that carries out laboratory activities at the request of competent law enforcement or judicial authorities; (q) "domestic accreditation body" means the sole body in a State that performs accreditation with authority derived from the State. Article 529 Establishment of domestic DNA analysis files 1. The States shall open and keep domestic DNA analysis files for the investigation of criminal offences. 2. For the purpose of implementing this Title, the States shall ensure the availability of DNA reference data from their domestic DNA analysis files as referred to in paragraph 1. 3. The States shall declare the domestic DNA analysis files to which Articles 529 to 532 and Articles 535, 536 and 539 apply and the conditions for automated searching as referred to in Article 530(1). Article 530 Automated searching of DNA profiles 1. For the investigation of criminal offences, States shall allow other States' national contact points as referred to in Article 535 access to the DNA reference data in their DNA analysis files, with the power to conduct automated searches by comparing DNA profiles. Searches may be conducted only in individual cases and in compliance with the requesting State's domestic law. 2. If an automated search shows that a DNA profile supplied matches DNA profiles entered in the requested State's searched file, the requested State shall send to the national contact point of the requesting State in an automated way the DNA reference data with which a match has been found. If no match can be found, this shall be notified automatically. Article 531 Automated comparison of DNA profiles 1. For the investigation of criminal offences, the States, via their national contact points, shall compare the DNA profiles of their unidentified DNA profiles with all DNA profiles from other domestic DNA analysis files' reference data in accordance with mutually accepted practical arrangements between the States concerned. DNA profiles shall be supplied and compared in automated form. Unidentified DNA profiles shall be supplied for comparison only where provided for under the requesting State's domestic law. 2. If a State, as a result of the comparison referred to in paragraph 1, finds that any DNA profiles supplied by another State match any of those in its DNA analysis files, it shall supply that other State's national contact point with the DNA reference data with which a match has been found without delay. Article 532 Collection of cellular material and supply of DNA profiles Where, in ongoing investigations or criminal proceedings, there is no DNA profile available for a particular individual present within a requested State's territory, the requested State shall provide legal assistance by collecting and examining cellular material from that individual and by supplying the DNA profile obtained to the requesting State, if: (a) the requesting State specifies the purpose for which it is required; (b) the requesting State produces an investigation warrant or statement issued by the competent authority, as required under that State's domestic law, showing that the requirements for collecting and examining cellular material would be fulfilled if the individual concerned were present within the requesting State's territory; and (c) under the requested State's law, the requirements for collecting and examining cellular material and for supplying the DNA profile obtained are fulfilled. Article 533 Dactyloscopic data For the purpose of implementing this Title, the States shall ensure the availability of dactyloscopic reference data from the file for the domestic automated fingerprint identification systems established for the prevention and investigation of criminal offences. Article 534 Automated searching of dactyloscopic data 1. For the prevention and investigation of criminal offences, States shall allow other States' national contact points, as referred to in Article 535, access to the reference data in the automated fingerprint identification systems which they have established for that purpose, with the power to conduct automated searches by comparing dactyloscopic data. Searches may be conducted only in individual cases and in compliance with the requesting State's domestic law. 2. The confirmation of a match of dactyloscopic data with reference data held by the requested State shall be carried out by the national contact point of the requesting State by means of the automated supply of the reference data required for a clear match. Article 535 National contact points 1. For the purposes of the supply of data as referred to in Articles 530, 531 and 534, the States shall designate national contact points. 2. In respect of the Member States, national contact points designated for an analogous exchange of data within the Union shall be considered as national contact points for the purpose of this Title. 3. The powers of the national contact points shall be governed by the applicable domestic law. Article 536 Supply of further personal data and other information If the procedure referred to in Articles 530, 531 and 534 show a match between DNA profiles or dactyloscopic data, the supply of further available personal data and other information relating to the reference data shall be governed by the domestic law, including the legal assistance rules, of the requested State, without prejudice to Article 539(1). Article 537 Automated searching of vehicle registration data 1. For the prevention and investigation of criminal offences and in dealing with other offences within the jurisdiction of the courts or a public prosecutor in the requesting State, as well as in maintaining public security, States shall allow other States' national contact points, as referred to in paragraph 2, access to the following domestic vehicle registration data, with the power to conduct automated searches in individual cases: (a) data relating to owners or operators; and (b) data relating to vehicles. 2. Searches may be conducted under paragraph 1 only with a full chassis number or a full registration number and in compliance with the requesting State's domestic law. 3. For the purposes of the supply of data as referred to in paragraph 1, the States shall designate a national contact point for incoming requests from other States. The powers of the national contact points shall be governed by the applicable domestic law. Article 538 Accreditation of forensic service providers carrying out laboratory activities 1. The States shall ensure that their forensic service providers carrying out laboratory activities are accredited by a domestic accreditation body as complying with EN ISO/IEC 17025. 2. Each State shall ensure that the results of accredited forensic service providers carrying out laboratory activities in other States are recognised by its authorities responsible for the prevention, detection, and investigation of criminal offences as being equally reliable as the results of domestic forensic service providers carrying out laboratory activities accredited to EN ISO/IEC 17025. 3. The competent law enforcement authorities of the United Kingdom shall not carry out searches and automated comparison in accordance with Articles 530, 531 and 534 before the United Kingdom has implemented and applied the measures referred to in paragraph 1 of this Article. 4. Paragraphs 1 and 2 do not affect domestic rules on the judicial assessment of evidence. 5. The United Kingdom shall communicate to the Specialised Committee on Law Enforcement and Judicial Cooperation the text of the main provisions adopted to implement and apply the provisions of this Article. Article 539 Implementing measures 1. For the purposes of this Title, States shall make all categories of data available for searching and comparison to the competent law enforcement authorities of other States under conditions equal to those under which they are available for searching and comparison by domestic competent law enforcement authorities. States shall supply further available personal data and other information relating to the reference data as referred to in Article 536 to the competent law enforcement authorities of other States for the purposes of this Title under conditions equal to those under which they would be supplied to domestic authorities. 2. For the purpose of implementing the procedures referred to in Articles 530, 531, 534 and 537, technical and procedural specifications are laid down in Annex 39. 3. The declarations made by Member States in accordance with Council Decisions 2008/615/JHA (77) and 2008/616/JHA (78) shall also apply in their relations with the United Kingdom. Article 540 Ex ante evaluation 1. In order to verify whether the United Kingdom has fulfilled the conditions set out in Article 539 and Annex 39, an evaluation visit and a pilot run, to the extent required by Annex 39, shall be carried out in respect of, and under conditions and arrangements acceptable to, the United Kingdom. In any event, a pilot run shall be carried out in relation to the searching of data under Article 537. 2. On the basis of an overall evaluation report on the evaluation visit and, where applicable, the pilot run, as referred to in paragraph 1, the Union shall determine the date or dates from which personal data may be supplied by Member States to the United Kingdom pursuant to this Title. 3. Pending the outcome of the evaluation referred to in paragraph 1, from the date of the entry into force of this Agreement, Member States may supply to the United Kingdom personal data as referred to in Articles 530, 531, 534 and 536 until the date or dates determined by the Union in accordance with paragraph 2 of this Article, but not longer than nine months after the entry into force of this Agreement. The Specialised Committee on Law Enforcement and Judicial Cooperation may extend this period once by a maximum of nine months. Article 541 Suspension and disapplication 1. In the event that the Union considers it necessary to amend this Title because Union law relating to the subject matter governed by this Title is amended substantially, or is in the process of being amended substantially, it may notify the United Kingdom accordingly with a view to agreeing on a formal amendment of this Agreement in relation to this Title. Following such notification, the Parties shall engage in consultations. 2. Where within nine months of that notification the Parties have not reached an agreement amending this Title, the Union may decide to suspend the application of this Title or any provisions of this Title for a period of up to nine months. Before the end of that period, the Parties may agree on an extension of the suspension for an additional period of up to nine months. If by the end of the suspension period the Parties have not reached an agreement amending this Title, the suspended provisions shall cease to apply on the first day of the month following the expiry of the suspension period, unless the Union informs the United Kingdom that it no longer seeks any amendment to this Title. In that case, the suspended provisions of this Title shall be reinstated. 3. If any of the provisions of this Title are suspended under this Article, the Specialised Committee on Law Enforcement and Judicial Cooperation shall meet to decide what steps are needed to ensure that any cooperation initiated under this Title and affected by the suspension is concluded in an appropriate manner. In any event, with regard to all personal data obtained through cooperation under this Title before the provisions concerned by the suspension provisionally cease to apply, the Parties shall ensure that the level of protection under which the personal data were transferred is maintained after the suspension takes effect. TITLE III TRANSFER AND PROCESSING OF PASSENGER NAME RECORD DATA Article 542 Scope 1. This Title lays down rules under which passenger name record data may be transferred to, processed and used by the United Kingdom competent authority for flights between the Union and the United Kingdom, and establishes specific safeguards in that regard. 2. This Title applies to air carriers operating passenger flights between the Union and the United Kingdom. 3. This Title also applies to air carriers incorporated, or storing data, in the Union and operating passenger flights to or from the United Kingdom. 4. This Title also provides for police and judicial cooperation in criminal matters between the United Kingdom and the Union in respect of PNR data. Article 543 Definitions For the purposes of this Title, the following definitions apply: (a) "air carrier" means an air transport undertaking with a valid operating licence or equivalent permitting it to carry out carriage of passengers by air between the United Kingdom and the Union; (b) "passenger name record" ("PNR") means a record of each passenger's travel requirements which contains information necessary to enable reservations to be processed and controlled by the booking and participating air carriers for each journey booked by or on behalf of any person, whether it is contained in reservation systems, departure control systems used to check passengers into flights, or equivalent systems providing the same functionalities; specifically, as used in this Title, PNR data consists of the elements set out in Annex 40; (c) "United Kingdom competent authority" means the United Kingdom authority responsible for receiving and processing PNR data under this Agreement; if the United Kingdom has more than one competent authority it shall provide a passenger data single window facility that allows air carriers to transfer PNR data to a single data transmission entry point and shall designate a single point of contact for the purpose of receiving and making requests under Article 546; (d) "Passenger Information Units" ("PIUs") means the Units established or designated by Member States that are responsible for receiving and processing PNR data; (e) "terrorism" means any offence listed in Annex 45; (f) "serious crime" means any offence punishable by a custodial sentence or detention order for a maximum period of at least three years under the domestic law of the United Kingdom. Article 544 Purposes of the use of PNR data 1. The United Kingdom shall ensure that PNR data received pursuant to this Title is processed strictly for the purposes of preventing, detecting, investigating or prosecuting terrorism or serious crime and for the purposes of overseeing the processing of PNR data within the terms set out in this Agreement. 2. In exceptional cases, the United Kingdom competent authority may process PNR data where necessary to protect the vital interests of any natural person, such as: (a) a risk of death or serious injury; or (b) a significant public health risk, in particular as identified under internationally recognised standards. 3. The United Kingdom competent authority may also process PNR data on a case-by-case basis where the disclosure of relevant PNR data is compelled by a United Kingdom court or administrative tribunal in a proceeding directly related to any of the purposes referred to in paragraph 1. Article 545 Ensuring PNR data is provided 1. The Union shall ensure that air carriers are not prevented from transferring PNR data to the United Kingdom competent authority pursuant to this Title. 2. The Union shall ensure that air carriers may transfer PNR data to the United Kingdom competent authority through authorised agents, who act on behalf of and under the responsibility of an air carrier, pursuant to this Title. 3. The United Kingdom shall not require an air carrier to provide elements of PNR data which are not already collected or held by the air carrier for reservation purposes. 4. The United Kingdom shall delete any data transferred to it by an air carrier pursuant to this Title upon receipt of that data, if that data element is not listed in Annex 40. Article 546 Police and judicial cooperation 1. The United Kingdom competent authority shall share with Europol or Eurojust, within the scope of their respective mandates, or with the PIUs of the Member States all relevant and appropriate analytical information containing PNR data as soon as possible in specific cases where necessary to prevent, detect, investigate, or prosecute terrorism or serious crime. 2. At the request of Europol or Eurojust, within the scope of their respective mandates, or of the PIU of a Member State, the United Kingdom competent authority shall share PNR data, the results of processing those data, or analytical information containing PNR data, in specific cases where necessary to prevent, detect, investigate, or prosecute terrorism or serious crime. 3. The PIUs of the Member States shall share with the United Kingdom competent authority all relevant and appropriate analytical information containing PNR data as soon as possible in specific cases where necessary to prevent, detect, investigate, or prosecute terrorism or serious crime. 4. At the request of the United Kingdom competent authority, the PIUs of the Member States shall share PNR data, the results of processing those data, or analytical information containing PNR data, in specific cases where necessary to prevent, detect, investigate, or prosecute terrorism or serious crime. 5. The Parties shall ensure that the information referred to in paragraphs 1 to 4 is shared in accordance with agreements and arrangements on law enforcement or information sharing between the United Kingdom and Europol, Eurojust, or the relevant Member State. In particular, the exchange of information with Europol under this Article shall take place through the secure communication line established for the exchange of information through Europol. 6. The United Kingdom competent authority and the PIUs of the Member States shall ensure that only the minimum amount of PNR data necessary is shared under paragraphs 1 to 4. Article 547 Non-discrimination The United Kingdom shall ensure that the safeguards applicable to the processing of PNR data apply to all natural persons on an equal basis without unlawful discrimination. Article 548 Use of special categories of personal data Any processing of special categories of personal data shall be prohibited under this Title. To the extent that any PNR data which is transferred to the United Kingdom competent authority includes special categories of personal data, the United Kingdom competent authority shall delete such data. Article 549 Data security and integrity 1. The United Kingdom shall implement regulatory, procedural or technical measures to protect PNR data against accidental, unlawful or unauthorised access, processing or loss. 2. The United Kingdom shall ensure compliance verification and the protection, security, confidentiality, and integrity of the data. In that regard, the United Kingdom shall: (a) apply encryption, authorisation, and documentation procedures to the PNR data; (b) limit access to PNR data to authorised officials; (c) hold PNR data in a secure physical environment that is protected with access controls; and (d) establish a mechanism that ensures that PNR data queries are conducted in a manner consistent with Article 544. 3. If a natural person's PNR data is accessed or disclosed without authorisation, the United Kingdom shall take measures to notify that natural person, to mitigate the risk of harm, and to take remedial action. 4. The United Kingdom competent authority shall promptly inform the Specialised Committee on Law Enforcement and Judicial Cooperation of any significant incident of accidental, unlawful or unauthorised access, processing or loss of PNR data. 5. The United Kingdom shall ensure that any breach of data security, in particular any breach leading to accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, or any unlawful forms of processing, are subject to effective and dissuasive corrective measures which may include sanctions. Article 550 Transparency and notification of passengers 1. The United Kingdom competent authority shall make the following available on its website: (a) a list of the legislation authorising the collection of PNR data; (b) the purposes for the collection of PNR data; (c) the manner of protecting PNR data; (d) the manner and extent to which PNR data may be disclosed; (e) information regarding the rights of access, correction, notation and redress; and (f) contact information for inquiries. 2. The Parties shall work with interested third parties, such as the aviation and air travel industry, to promote transparency at the time of booking regarding the purpose of the collection, processing and use of PNR data, and regarding how to request access, correction and redress. Air carriers shall provide passengers with clear and meaningful information in relation to the transfer of PNR data under this Title, including the details of the recipient authority, the purpose of the transfer and the right to request from the recipient authority, access to and correction of the personal data of the passenger that has been transferred. 3. Where PNR data retained in accordance with Article 552 has been used subject to the conditions set out in Article 553 or has been disclosed in accordance with Article 555 or Article 556, the United Kingdom shall notify the passengers concerned in writing, individually and within a reasonable time once such notification is no longer liable to jeopardise the investigations by the public authorities concerned to the extent that the relevant contact information of the passengers is available or can be retrieved, taking into account reasonable efforts. The notification shall include information on how the natural person concerned can seek administrative or judicial redress. Article 551 Automated processing of PNR data 1. The United Kingdom competent authority shall ensure that any automated processing of PNR data is based on non-discriminatory, specific and reliable pre-established models and criteria to enable it to: (a) arrive at results targeting natural persons who might be under a reasonable suspicion of involvement or participation in terrorism or serious crime; or (b) in exceptional circumstances, protect the vital interests of any natural person as set out in Article 544(2). 2. The United Kingdom competent authority shall ensure that the databases against which PNR data are compared are reliable, up to date and limited to those databases it uses in relation to the purposes set out in Article 544. 3. The United Kingdom shall not take any decision adversely affecting a natural person in a significant manner solely on the basis of automated processing of PNR data. Article 552 Retention of PNR data 1. The United Kingdom shall not retain PNR data for more than five years from the date that it receives the PNR data. 2. No later than six months after the transfer of the PNR data referred to in paragraph 1, all PNR data shall be depersonalised by masking out the following data elements which could serve to identify directly the passenger to whom the PNR data relate or any other natural person: (a) names, including the names of other passengers on the PNR and number of passengers on the PNR travelling together; (b) addresses, telephone numbers and electronic contact information of the passenger, the persons who made the flight reservation for the passenger, persons through whom the air passenger may be contacted and persons who are to be informed in the event of an emergency; (c) all available payment and billing information, to the extent that it contains any information which could serve to identify a natural person; (d) frequent flyer information; (e) other supplementary information (OSI), special service information (SSI) and special service request (SSR) information, to the extent that they contain any information which could serve to identify a natural person; and (f) any advance passenger information (API) data that have been collected. 3. The United Kingdom competent authority may unmask PNR data only if it is necessary to carry out investigations for the purposes set out in Article 544. Such unmasked PNR data shall be accessible only to a limited number of specifically authorised officials. 4. Notwithstanding paragraph 1, the United Kingdom shall delete the PNR data of passengers after their departure from the country unless a risk assessment indicates the need to retain such PNR data. In order to establish that need, the United Kingdom shall identify objective evidence from which it may be inferred that certain passengers present the existence of a risk in terms of the fight against terrorism and serious crime. 5. For the purposes of paragraph 4, unless information is available on the exact date of departure, the date of departure should be considered as the last day of the period of maximum lawful stay in the United Kingdom of the passenger concerned. 6. The use of the data retained under this Article is subject to the conditions laid down in Article 553. 7. An independent administrative body in the United Kingdom shall assess on a yearly basis the approach applied by the United Kingdom competent authority as regards the need to retain PNR data pursuant to paragraph 4. 8. Notwithstanding paragraphs 1, 2 and 4, the United Kingdom may retain PNR data required for any specific action, review, investigation, enforcement action, judicial proceeding, prosecution, or enforcement of penalties, until concluded. 9. The United Kingdom shall delete the PNR data at the end of the PNR data retention period. 10. Paragraph 11 applies due to the special circumstances that prevent the United Kingdom from making the technical adjustments necessary to transform the PNR processing systems which the United Kingdom operated whilst Union law applied to it into systems which would enable PNR data to be deleted in accordance with paragraph 4. 11. The United Kingdom may derogate from paragraph 4 on a temporary basis for an interim period, the duration of which is provided for in paragraph 13, pending the implementation by the United Kingdom of technical adjustments as soon as possible. During the interim period, the United Kingdom competent authority shall prevent the use of the PNR data that is to be deleted in accordance with paragraph 4 by applying the following additional safeguards to that PNR data: (a) the PNR data shall be accessible only to a limited number of authorised officials and only where necessary to determine whether the PNR data should be deleted in accordance with paragraph 4; (b) the request to use the PNR data shall be refused in cases where the data is to be deleted in accordance with paragraph 4, and no further access shall be granted to that data where the documentation referred to in point (d) of this paragraph indicates that an earlier request for use has been refused; (c) deletion of the PNR data shall be ensured as soon as possible using best efforts, taking into account the special circumstances referred to in paragraph 10; and (d) the following shall be documented in accordance with Article 554, and such documentation shall be made available to the independent administrative body referred to in paragraph 7 of this Article: (i) any requests to use the PNR data; (ii) the date and time of the access to the PNR data for the purpose of assessing whether deletion of the PNR data was required; (iii) that the request to use the PNR data was refused on the basis that the PNR data should have been deleted under paragraph 4, including the date and time of the refusal; and (iv) the date and time of the deletion of the PNR data in accordance with point (c) of this paragraph. 12. The United Kingdom shall provide to the Specialised Committee on Law Enforcement and Judicial Cooperation, nine months after the entry into force of this Agreement and again a year later if the interim period is extended for a further year: (a) a report from the independent administrative body referred to in paragraph 7 of this Article, which shall include the opinion of the United Kingdom supervisory authority referred to in Article 525(3) as to whether the safeguards provided for in paragraph 11 of this Article have been effectively applied; and (b) the assessment of the United Kingdom of whether the special circumstances referred to in paragraph 10 of this Article persist, together with a description of the efforts made to transform the PNR processing systems of the United Kingdom into systems which would enable PNR data to be deleted in accordance with paragraph 4 of this Article. 13. The Specialised Committee on Law Enforcement and Judicial Cooperation shall meet within one year of the entry into force of this Agreement to consider the report and assessment provided under paragraph 12. Where the special circumstances referred to in paragraph 10 persist, the Partnership Council shall extend the interim period referred to in paragraph 11 for one year. The Partnership Council shall extend the interim period for one further final year, under the same conditions and following the same procedure as for the first extension where, in addition, substantial progress has been made, although it has not yet been possible to transform the United Kingdom PNR processing systems into systems which would enable PNR data to be deleted in accordance with paragraph 4. 14. If the United Kingdom considers that a refusal by the Partnership Council to grant either of those extensions was not justified, it may suspend this Title with one month's notice. 15. On the third anniversary of the date of entry into force of this Agreement, paragraphs 10 to 14 shall cease to apply. Article 553 Conditions for the use of PNR data 1. The United Kingdom competent authority may use PNR data retained in accordance with Article 552 for purposes other than security and border control checks, including any disclosure under Article 555 and Article 556, only where new circumstances based on objective grounds indicate that the PNR data of one or more passengers might make an effective contribution to the attainment of the purposes set out in Article 544. 2. Use of PNR data by the United Kingdom competent authority in accordance with paragraph 1 shall be subject to prior review by a court or by an independent administrative body in the United Kingdom based on a reasoned request by the United Kingdom competent authority submitted within the domestic legal framework of procedures for the prevention, detection or prosecution of crime, except: (a) in cases of validly established urgency; or (b) for the purpose of verifying the reliability and currency of the pre-established models and criteria on which the automated processing of PNR data is based, or of defining new models and criteria for such processing. Article 554 Logging and documenting of PNR data processing The United Kingdom competent authority shall log and document all processing of PNR data. It shall only use such logging or documentation to: (a) self-monitor and to verify the lawfulness of data processing; (b) ensure proper data integrity; (c) ensure the security of data processing; and (d) ensure oversight. Article 555 Disclosure within the United Kingdom 1. The United Kingdom competent authority shall not disclose PNR data to other public authorities in the United Kingdom unless the following conditions are met: (a) the PNR data is disclosed to public authorities whose functions are directly related to the purposes set out in Article 544; (b) the PNR data is disclosed only on a case-by-case basis; (c) the disclosure is necessary, in the particular circumstances, for the purposes set out in Article 544; (d) only the minimum amount of PNR data necessary is disclosed; (e) the receiving public authority affords protection equivalent to the safeguards described in this Title; and (f) the receiving public authority does not disclose the PNR data to another entity unless the disclosure is authorised by the United Kingdom competent authority in accordance with the conditions laid down in this paragraph. 2. When transferring analytical information containing PNR data obtained under this Title, the safeguards set out in this Article shall apply. Article 556 Disclosure outside the United Kingdom 1. The United Kingdom shall ensure that the United Kingdom competent authority does not disclose PNR data to public authorities in third countries unless all the following conditions are met: (a) the PNR data is disclosed to public authorities whose functions are directly related to the purposes set out in Article 544; (b) the PNR data is disclosed only on a case-by-case basis; (c) the PNR data is disclosed only if necessary for the purposes set out in Article 544; (d) only the minimum amount of PNR data necessary is disclosed; and (e) the third country to which the PNR data is disclosed has either concluded an agreement with the Union that provides for the protection of personal data comparable to this Agreement or is subject to a decision of the European Commission pursuant to Union law that finds that the third country ensures an adequate level of data protection within the meaning of Union law. 2. As an exception to point (e) of paragraph 1, the United Kingdom competent authority may transfer PNR data to a third country if: (a) the head of that authority, or a senior official specifically mandated by the head, considers that the disclosure is necessary for the prevention and investigation of a serious and imminent threat to public security or to protect the vital interests of any natural person; and (b) the third country provides a written assurance, pursuant to an arrangement, agreement or otherwise, that the information shall be protected in line with the safeguards applicable under United Kingdom law to the processing of PNR data received from the Union, including those set out in this Title. 3. A transfer in accordance with paragraph 2 of this Article shall be documented. Such documentation shall be made available to the supervisory authority referred to in Article 525(3) on request, including the date and time of the transfer, information about the receiving authority, the justification for the transfer and the PNR data transferred. 4. If, in accordance with paragraph 1 or 2, the United Kingdom competent authority discloses PNR data collected under this Title that originates in a Member State, the United Kingdom competent authority shall notify the authorities of that Member State of the disclosure at the earliest appropriate opportunity. The United Kingdom shall make that notification in accordance with agreements or arrangements on law enforcement or information sharing between the United Kingdom and that Member State. 5. When transferring analytical information containing PNR data obtained under this Title, the safeguards set out in this Article shall apply. Article 557 Method of transfer Air carriers shall transfer PNR data to the United Kingdom competent authority exclusively on the basis of the "push method", a method by which air carriers transfer PNR data into the database of the United Kingdom competent authority, and in accordance with the following procedures to be observed by air carriers, by which they: (a) transfer PNR data by electronic means in compliance with the technical requirements of the United Kingdom competent authority or, in the case of a technical failure, by any other appropriate means ensuring an appropriate level of data security; (b) transfer PNR data using a mutually accepted messaging format; and (c) transfer PNR data in a secure manner using common protocols as required by the United Kingdom competent authority. Article 558 Frequency of transfer 1. The United Kingdom competent authority shall require air carriers to transfer the PNR data: (a) initially from no earlier than 96 hours before the scheduled flight service departure time; and (b) a maximum number of five times as specified by the United Kingdom competent authority. 2. The United Kingdom competent authority shall permit air carriers to limit the transfer referred to in point (b) of paragraph 1 to updates of the PNR data transferred as referred to in point (a) of that paragraph. 3. The United Kingdom competent authority shall inform air carriers of the specified times for the transfers. 4. In specific cases where there is an indication that additional access to PNR data is necessary to respond to a specific threat related to the purposes set out in Article 544, the United Kingdom competent authority may require an air carrier to provide PNR data prior to, between or after the scheduled transfers. In exercising that discretion, the United Kingdom competent authority shall act judiciously and proportionately, and shall use the method of transfer described in Article 557. Article 559 Cooperation The United Kingdom competent authority and the PIUs of the Member States shall cooperate to pursue the coherence of their PNR data processing regimes in a manner that further enhances the security of individuals in the United Kingdom, the Union and elsewhere. Article 560 Non-derogation This Title shall not be construed as derogating from any obligation between the United Kingdom and Member States or third countries to make or respond to a request under a mutual assistance instrument. Article 561 Consultation and review 1. The Parties shall advise each other of any measure that is to be enacted that may affect this Title. 2. When carrying out joint reviews of this Title as referred to in Article 691(1), the Parties shall pay particular attention to the necessity and proportionality of processing and retaining PNR data for each of the purposes set out in Article 544. The joint reviews shall also include an examination of how the United Kingdom competent authority has ensured that the pre-established models, criteria and databases referred to in Article 551 are reliable, relevant and current, taking into account statistical data. Article 562 Suspension of cooperation under this Title 1. In the event that either Party considers that the continued operation of this Title is no longer appropriate, it may notify the other Party accordingly of its intention to suspend the application of this Title. Following such notification, the Parties shall engage in consultations. 2. Where within 6 months of that notification the Parties have not reached a resolution, either Party may decide to suspend the application of this Title for a period of up to 6 months. Before the end of that period, the Parties may agree an extension of the suspension for an additional period of up to 6 months. If by the end of the suspension period the Parties have not reached a resolution with respect to this Title, this Title shall cease to apply on the first day of the month following the expiry of the suspension period, unless the notifying Party informs the other Party that it wishes to withdraw the notification. In that case, the provisions of this Title shall be reinstated. 3. If this Title is suspended under this Article, the Specialised Committee on Law Enforcement and Judicial Cooperation shall meet to decide what steps are needed to ensure that any cooperation initiated under this Title that is affected by the suspension is concluded in an appropriate manner. In any event, with regard to all personal data obtained through cooperation under this Title before the provisions concerned by the suspension provisionally cease to apply, the Parties shall ensure that the level of protection under which the personal data were transferred is maintained after the suspension takes effect. TITLE IV COOPERATION ON OPERATIONAL INFORMATION Article 563 Cooperation on Operational Information 1. The objective of this Title is for the Parties to ensure that the competent authorities of the United Kingdom and of the Member States are able to, subject to the conditions of their domestic law and within the scope of their powers, and to the extent that this is not provided for in other Titles of this Part, assist each other through the provision of relevant information for the purposes of: (a) the prevention, investigation, detection or prosecution of criminal offences; (b) the execution of criminal penalties; (c) safeguarding against, and the prevention of, threats to public safety; and (d) the prevention and combating of money laundering and the financing of terrorism. 2. For the purposes of this Title, a "competent authority" means a domestic police, customs or other authority that is competent under domestic law to undertake activities for the purposes set out in paragraph 1. 3. Information, including information on wanted and missing persons as well as objects, may be requested by a competent authority of the United Kingdom or of a Member State, or provided spontaneously to a competent authority of the United Kingdom or of a Member State. Information may be provided in response to a request or spontaneously, subject to the conditions of the domestic law which applies to the providing competent authority and within the scope of its powers. 4. Information may be requested and provided to the extent that the conditions of the domestic law which applies to the requesting or providing competent authority do not stipulate that the request or provision of information has to be made or channelled via judicial authorities. 5. In urgent cases, the providing competent authority shall respond to a request, or provide information spontaneously, as soon as possible. 6. A competent authority of the requesting State may, in accordance with relevant domestic law, at the time of making the request or at a later point in time, seek consent from the providing State for the information to be used for evidential purposes in proceedings before a judicial authority. The providing State may, subject to the conditions set out in Title VIII and the conditions of the domestic law which applies to it, consent to the information being used for evidential purposes before a judicial authority in the requesting State. Equally, where information is provided spontaneously, the providing State may consent to the information being used for evidential purposes in proceedings before a judicial authority in the receiving State. Where consent is not given under this paragraph, the information received shall not be used for evidential purposes in proceedings before a judicial authority. 7. The providing competent authority may, under relevant domestic law, impose conditions on the use of the information provided. 8. A competent authority may provide under this Title any type of information which it holds, subject to the conditions of the domestic law which applies to it and within the scope of its powers. This may include information from other sources, only if onward transfer of that information is permitted in the framework under which it was obtained by the providing competent authority. 9. Information may be provided under this Title via any appropriate communication channel, including the secure communication line for the purpose of provision of information through Europol. 10. This Article shall not affect the operation or conclusion of bilateral agreements between the United Kingdom and Member States, provided that the Member States act in compliance with Union law. It shall also not affect any other powers which are available to the competent authorities of the United Kingdom or of the Member States under applicable domestic or international law to provide assistance through the sharing of information for the purposes set out in paragraph 1. TITLE V COOPERATION WITH EUROPOL Article 564 Objective The objective of this Title is to establish cooperative relations between Europol and the competent authorities of the United Kingdom in order to support and strengthen the action by the Member States and the United Kingdom, as well as their mutual cooperation in preventing and combating serious crime, terrorism and forms of crime which affect a common interest covered by a Union policy, as referred to in Article 566. Article 565 Definitions For the purposes of this Title, the following definitions apply: (a) "Europol" means the European Union Agency for Law Enforcement Cooperation, set up under Regulation (EU) 2016/794 of the European Parliament and of the Council (79) (the "Europol Regulation"); (b) "competent authority" means, for the Union, Europol and, for the United Kingdom, a domestic law enforcement authority responsible under domestic law for preventing and combating criminal offences; Article 566 Forms of crime 1. The cooperation established under this Title relates to the forms of crime within Europol's competence, as listed in Annex 41, including related criminal offences. 2. Related criminal offences are criminal offences committed in order to procure the means of committing the forms of crime referred to in paragraph 1, criminal offences committed in order to facilitate or carry out such crimes, and criminal offences committed to ensure impunity for such crimes. 3. Where the list of forms of crime for which Europol is competent under Union law is changed, the Specialised Committee on Law Enforcement and Judicial Cooperation may, upon a proposal from the Union, amend Annex 41 accordingly from the date when the change to Europol's competence enters into effect. Article 567 Scope of cooperation The cooperation may, in addition to the exchange of personal data under the conditions laid down in this Title and in accordance with the tasks of Europol as outlined in the Europol Regulation, in particular include: (a) the exchange of information such as specialist knowledge; (b) general situation reports; (c) results of strategic analysis; (d) information on criminal investigation procedures; (e) information on crime prevention methods; (f) participation in training activities; and (g) the provision of advice and support in individual criminal investigations as well as operational cooperation. Article 568 National contact point and liaison officers 1. The United Kingdom shall designate a national contact point to act as the central point of contact between Europol and the competent authorities of the United Kingdom. 2. The exchange of information between Europol and the competent authorities of the United Kingdom shall take place between Europol and the national contact point referred to in paragraph 1. This does not preclude, however, direct exchanges of information between Europol and the competent authorities of the United Kingdom, if considered appropriate by both Europol and the relevant competent authorities. 3. The national contact point shall also be the central point of contact in respect of review, correction and deletion of personal data. 4. To facilitate the cooperation established under this Title, the United Kingdom shall second one or more liaison officers to Europol. Europol may second one or more liaison officers to the United Kingdom. 5. The United Kingdom shall ensure that its liaison officers have speedy and, where technically possible, direct access to the relevant domestic databases of the United Kingdom that are necessary for them to fulfil their tasks. 6. The number of liaison officers, the details of their tasks, their rights and obligations and the costs involved shall be governed by working arrangements concluded between Europol and the competent authorities of the United Kingdom as referred to in Article 577. 7. Liaison officers from the United Kingdom and representatives of the competent authorities of the United Kingdom may be invited to operational meetings. Member State liaison officers and third-country liaison officers, representatives of competent authorities from the Member States and third countries, Europol staff and other stakeholders may attend meetings organised by the liaison officers or the competent authorities of the United Kingdom. Article 569 Exchanges of information 1. Exchanges of information between the competent authorities shall comply with the objective and provisions of this Title. Personal data shall be processed only for the specific purposes referred to in paragraph 2. 2. The competent authorities shall clearly indicate, at the latest at the moment of transferring personal data, the specific purpose or purposes for which the personal data are being transferred. For transfers to Europol, the purpose or purposes of such transfer shall be specified in line with the specific purposes of processing set out in the Europol Regulation. If the transferring competent authority has not done so, the receiving competent authority, in agreement with the transferring authority, shall process the personal data in order to determine their relevance as well as the purpose or purposes for which it is to be further processed. The competent authorities may process personal data for a purpose other than the purpose for which they have been provided only if authorised to do so by the transferring competent authority. 3. The competent authorities receiving the personal data shall give an undertaking stating that such data will be processed only for the purpose for which they were transferred. The personal data shall be deleted as soon as they are no longer necessary for the purpose for which they were transferred. 4. Europol and the competent authorities of the United Kingdom shall determine without undue delay, and in any event no later than six months after receipt of the personal data, if and to what extent those personal data are necessary for the purpose for which they were transferred and inform the transferring authority accordingly. Article 570 Restrictions on access to and further use of transferred personal data 1. The transferring competent authority may indicate, at the moment of transferring personal data, any restriction on access thereto or the use to be made thereof, in general or specific terms, including as regards its onward transfer, erasure or destruction after a certain period of time, or its further processing. Where the need for such restrictions becomes apparent after the personal data have been transferred, the transferring competent authority shall inform the receiving competent authority accordingly. 2. The receiving competent authority shall comply with any restriction on access or further use of the personal data indicated by the transferring competent authority as described in paragraph 1. 3. Each Party shall ensure that information transferred under this Title was collected, stored and transferred in accordance with its respective legal framework. Each Party shall ensure, as far as possible, that such information has not been obtained in violation of human rights. Nor shall such information be transferred if, to the extent reasonably foreseeable, it could be used to request, hand down or execute a death penalty or any form of cruel or inhuman treatment. Article 571 Different categories of data subjects 1. The transfer of personal data in respect of victims of a criminal offence, witnesses or other persons who can provide information concerning criminal offences, or in respect of persons under the age of 18, shall be prohibited unless such transfer is strictly necessary and proportionate in individual cases for preventing or combating a criminal offence. 2. The United Kingdom and Europol shall each ensure that the processing of personal data under paragraph 1 is subject to additional safeguards, including restrictions on access, additional security measures and limitations on onward transfers. Article 572 Facilitation of flow of personal data between the United Kingdom and Europol In the interest of mutual operational benefits, the Parties shall endeavour to cooperate in the future with a view to ensuring that data exchanges between Europol and the competent authorities of the United Kingdom can take place as quickly as possible, and to consider the incorporation of any new processes and technical developments which might assist with that objective, while taking account of the fact that the United Kingdom is not a Member State. Article 573 Assessment of reliability of the source and accuracy of information 1. The competent authorities shall indicate as far as possible, at the latest at the moment of transferring the information, the reliability of the source of the information on the basis of the following criteria: (a) where there is no doubt as to the authenticity, trustworthiness and competence of the source, or if the information is provided by a source which has proved to be reliable in all instances; (b) where the information is provided by a source which has in most instances proved to be reliable; (c) where the information is provided by a source which has in most instances proved to be unreliable; (d) where the reliability of the source cannot be assessed. 2. The competent authorities shall indicate as far as possible, at the latest at the moment of transferring the information, the accuracy of the information on the basis of the following criteria: (a) information the accuracy of which is not in doubt; (b) information known personally to the source but not known personally to the official passing it on; (c) information not known personally to the source but corroborated by other information already recorded; (d) information not known personally to the source and which cannot be corroborated. 3. Where the receiving competent authority, on the basis of information already in its possession, comes to the conclusion that the assessment of information or of its source supplied by the transferring competent authority in accordance with paragraphs 1 and 2 needs correction, it shall inform that competent authority and shall attempt to agree on an amendment to the assessment. The receiving competent authority shall not change the assessment of information received or of its source without such agreement. 4. If a competent authority receives information without an assessment, it shall attempt as far as possible and where possible in agreement with the transferring competent authority to assess the reliability of the source or the accuracy of the information on the basis of information already in its possession. 5. If no reliable assessment can be made, the information shall be evaluated as provided for in point (d) of paragraph 1 and point (d) of paragraph 2. Article 574 Security of the information exchange 1. The technical and organisational measures put in place to ensure the security of the information exchange under this Title shall be laid down in administrative arrangements between Europol and the competent authorities of the United Kingdom as referred to in Article 577. 2. The Parties agree on the establishment, implementation and operation of a secure communication line for the purpose of the exchange of information between Europol and the competent authorities of the United Kingdom. 3. Administrative arrangements between Europol and the competent authorities of the United Kingdom as referred to in Article 576 shall regulate the secure communication line's terms and conditions of use. Article 575 Liability for unauthorised or incorrect personal data processing 1. The competent authorities shall be liable, in accordance with their respective legal frameworks, for any damage caused to an individual as a result of legal or factual errors in information exchanged. In order to avoid liability under their respective legal frameworks vis-à-vis an injured party, neither Europol nor the competent authorities of the United Kingdom may plead that the other competent authority had transferred inaccurate information. 2. If damages are awarded either against Europol or against the competent authorities of the United Kingdom because of the use by either of them of information which was erroneously communicated by the other, or communicated as a result of a failure on the part of the other to comply with their obligations, the amount paid as compensation under paragraph 1 either by Europol or by the competent authorities of the United Kingdom shall be repaid by the other, unless the information was used in breach of this Title. 3. Europol and the competent authorities of the United Kingdom shall not require each other to pay for punitive or non-compensatory damages under paragraphs 1 and 2. Article 576 Exchange of classified and sensitive non-classified information The exchange and protection of classified and sensitive non-classified information, if necessary under this Title, shall be regulated in working and administrative arrangements as referred to in Article 577 between Europol and the competent authorities of the United Kingdom. Article 577 Working and administrative arrangements 1. The details of cooperation between the United Kingdom and Europol, as appropriate to complement and implement the provisions of this Title, shall be the subject of working arrangements in accordance with Article 23(4) of the Europol Regulation and administrative arrangements in accordance with Article 25(1) of the Europol Regulation concluded between Europol and the competent authorities of the United Kingdom. 2. Without prejudice to any provision in this Title and while reflecting the status of the United Kingdom as not being a Member State, Europol and the competent authorities of the United Kingdom shall, subject to a decision by Europol's Management Board, include, in working arrangements or administrative arrangements, as the case may be, provisions complementing or implementing this Title, in particular allowing for: (a) consultations between Europol and one or more representatives of the national contact point of the United Kingdom on policy issues and matters of common interest for the purpose of realising their objectives and coordinating their respective activities, and of furthering cooperation between Europol and the competent authorities of the United Kingdom; (b) the participation of one or more representatives of the United Kingdom as observer or observers in specific meetings of the Heads of Europol National Units in line with the rules of proceedings of such meetings; (c) the association of one or more representatives of the United Kingdom to operational analysis projects, in accordance with the rules set out by the appropriate Europol governance bodies; (d) the specification of liaison officers' tasks, their rights and obligations and the costs involved; or (e) cooperation between the competent authorities of the United Kingdom and Europol in the event of privacy or security breaches. 3. The substance of working and administrative arrangements may be set out together in one document. Article 578 Notification of implementation 1. The United Kingdom and Europol shall each make publicly available a document setting out in an intelligible form the provisions regarding the processing of personal data transferred under this Title including the means available for the exercise of the rights of data subjects, and shall each ensure that a copy of that document be provided to the other. 2. Where not already in place, the United Kingdom and Europol shall adopt rules specifying how compliance with the provisions regarding the processing of personal data will be enforced in practice. The United Kingdom and Europol shall each send a copy of those rules to the other and to the respective supervisory authorities. Article 579 Powers of Europol Nothing in this Title shall be construed as creating an obligation on Europol to cooperate with the competent authorities of the United Kingdom beyond Europol's competence as set out in the relevant Union law. TITLE VI COOPERATION WITH EUROJUST Article 580 Objective The objective of this Title is to establish cooperation between Eurojust and the competent authorities of the United Kingdom in combating serious crimes as referred to in Article 582. Article 581 Definitions For the purposes of this Title, the following definitions apply: (a) "Eurojust" means the European Union Agency for Criminal Justice Cooperation, set up under Regulation (EU) 2018/1727 of the European Parliament and of the Council (80) (the "Eurojust Regulation"); (b) "competent authority" means, for the Union, Eurojust, represented by the College or a National Member and, for the United Kingdom, a domestic authority with responsibilities under domestic law relating to the investigation and prosecution of criminal offences; (c) "College" means the College of Eurojust, as referred to in the Eurojust Regulation; (d) "National Member" means the National Member seconded to Eurojust by each Member State, as referred to in the Eurojust Regulation; (e) "Assistant" means a person who may assist a National Member and the National Member's Deputy, or the Liaison Prosecutor, as referred to in the Eurojust Regulation and in Article 585(3) respectively; (f) "Liaison Prosecutor" means a public prosecutor seconded by the United Kingdom to Eurojust and subject to the domestic law of the United Kingdom as regards the public prosecutor's status; (g) "Liaison Magistrate" means a magistrate posted by Eurojust to the United Kingdom in accordance with Article 586; (h) "Domestic Correspondent for Terrorism Matters" means the contact point designated by the United Kingdom in accordance with Article 584, responsible for handling correspondence related to terrorism matters. Article 582 Forms of crime 1. The cooperation established under this Title relates to the forms of serious crime within the competence of Eurojust, as listed in Annex 42, including related criminal offences. 2. Related criminal offences are the criminal offences committed in order to procure the means of committing forms of serious crime referred to in paragraph 1, criminal offences committed in order to facilitate or commit such serious crimes, and criminal offences committed to ensure impunity for such serious crimes. 3. Where the list of forms of serious crime for which Eurojust is competent under Union law is changed, the Specialised Committee on Law Enforcement and Judicial Cooperation may, upon a proposal from the Union, amend Annex 42 accordingly from the date when the change to Eurojust's competence enters into effect. Article 583 Scope of cooperation The Parties shall ensure that Eurojust and the competent authorities of the United Kingdom cooperate in the fields of activity set out in Articles 2 and 54 of the Eurojust Regulation and in this Title. Article 584 Contact points to Eurojust 1. The United Kingdom shall put in place or appoint at least one contact point to Eurojust within the competent authorities of the United Kingdom. 2. The United Kingdom shall designate one of its contact points as the United Kingdom Domestic Correspondent for Terrorism Matters. Article 585 Liaison Prosecutor 1. To facilitate the cooperation established under this Title, the United Kingdom shall second a Liaison Prosecutor to Eurojust. 2. The mandate and the duration of the secondment shall be determined by the United Kingdom. 3. The Liaison Prosecutor may be assisted by up to five Assistants, reflecting the volume of cooperation. When necessary, Assistants may replace the Liaison Prosecutor or act on the Liaison Prosecutor's behalf. 4. The United Kingdom shall inform Eurojust of the nature and extent of the judicial powers of the Liaison Prosecutor and the Liaison Prosecutor's Assistants within the United Kingdom to accomplish their tasks in accordance with this Title. The United Kingdom shall establish the competence of its Liaison Prosecutor and the Liaison Prosecutor's Assistants to act in relation to foreign judicial authorities. 5. The Liaison Prosecutor and the Liaison Prosecutor's Assistants shall have access to the information contained in the domestic criminal record, or in any other register of the United Kingdom, in accordance with domestic law in the case of a prosecutor or person of equivalent competence. 6. The Liaison Prosecutor and the Liaison Prosecutor's Assistants shall have the power to contact the competent authorities of the United Kingdom directly. 7. The number of Assistants referred to in paragraph 3 of this Article, the details of the tasks of the Liaison Prosecutor and the Liaison Prosecutor's Assistants, their rights and obligations and the costs involved shall be governed by a working arrangement concluded between Eurojust and the competent authorities of the United Kingdom as referred to in Article 594. 8. The working documents of the Liaison Prosecutor and the Liaison Prosecutor's Assistants shall be held inviolable by Eurojust. Article 586 Liaison Magistrate 1. For the purpose of facilitating judicial cooperation with the United Kingdom in cases in which Eurojust provides assistance, Eurojust may post a Liaison Magistrate to the United Kingdom, in accordance with Article 53 of the Eurojust Regulation. 2. The details of the Liaison Magistrate's tasks referred to in paragraph 1 of this Article, the Liaison Magistrate's rights and obligations and the costs involved, shall be governed by a working arrangement concluded between Eurojust and the competent authorities of the United Kingdom as referred to in Article 594. Article 587 Operational and strategic meetings 1. The Liaison Prosecutor, the Liaison Prosecutor's Assistants, and representatives of other competent authorities of the United Kingdom, including the contact point to Eurojust, may participate in meetings with regard to strategic matters at the invitation of the President of Eurojust and in meetings with regard to operational matters with the approval of the National Members concerned. 2. National Members, their Deputies and Assistants, the Administrative Director of Eurojust and Eurojust staff may attend meetings organised by the Liaison Prosecutor, the Liaison Prosecutor's Assistants, or other competent authorities of the United Kingdom, including the contact point to Eurojust. Article 588 Exchange of non-personal data Eurojust and the competent authorities of the United Kingdom may exchange any non-personal data in so far as those data are relevant for the cooperation under this Title, and subject to any restrictions pursuant to Article 593. Article 589 Exchange of personal data 1. Personal data requested and received by competent authorities under this Title shall be processed by them only for the objectives set out in Article 580, for the specific purposes referred to in paragraph 2 of this Article and subject to the restrictions on access or further use referred to in paragraph 3 of this Article. 2. The transferring competent authority shall clearly indicate, at the latest at the moment of transferring personal data, the specific purpose or purposes for which the data are being transferred. 3. The transferring competent authority may indicate, at the moment of transferring personal data, any restriction on access thereto or the use to be made thereof, in general or specific terms, including as regards its onward transfer, erasure or destruction after a certain period of time, or its further processing. Where the need for such restrictions becomes apparent after the personal data have been provided, the transferring authority shall inform the receiving authority accordingly. 4. The receiving competent authority shall comply with any restriction on access or further use of the personal data indicated by the transferring competent authority as provided for in paragraph 3. Article 590 Channels of transmission 1. Information shall be exchanged: (a) either between the Liaison Prosecutor or the Liaison Prosecutor's Assistants or, if none is appointed or otherwise available, the United Kingdom's contact point to Eurojust and the National Members concerned or the College; (b) if Eurojust has posted a Liaison Magistrate to the United Kingdom, between the Liaison Magistrate and any competent authority of the United Kingdom; in that event, the Liaison Prosecutor shall be informed of any such information exchanges; or (c) directly between a competent authority in the United Kingdom and the National Members concerned or the College; in that event, the Liaison Prosecutor and, if applicable, the Liaison Magistrate shall be informed of any such information exchanges. 2. Eurojust and the competent authorities of the United Kingdom may agree to use other channels for the exchange of information in particular cases. 3. Eurojust and the competent authorities of the United Kingdom shall each ensure that their respective representatives are authorised to exchange information at the appropriate level and in accordance with United Kingdom law and the Eurojust Regulation respectively, and are adequately screened. Article 591 Onward transfers The competent authorities of the United Kingdom and Eurojust shall not communicate any information provided by the other to any third country or international organisation without the consent of whichever of the competent authorities of the United Kingdom or Eurojust provided the information and without appropriate safeguards regarding the protection of personal data. Article 592 Liability for unauthorised or incorrect personal data processing 1. The competent authorities shall be liable, in accordance with their respective legal frameworks, for any damage caused to an individual as a result of legal or factual errors in information exchanged. In order to avoid liability under their respective legal frameworks vis-à-vis an injured party, neither Eurojust nor the competent authorities of the United Kingdom may plead that the other competent authority had transferred inaccurate information. 2. If damages are awarded against any competent authority because of its use of information which was erroneously communicated by the other, or communicated as a result of a failure on the part of the other to comply with their obligations, the amount paid as compensation under paragraph 1 by the competent authority shall be repaid by the other, unless the information was used in breach of this Title. 3. Eurojust and the competent authorities of the United Kingdom shall not require each other to pay for punitive or non-compensatory damages under paragraphs 1 and 2. Article 593 Exchange of classified and sensitive non-classified information The exchange and protection of classified and sensitive non-classified information, if necessary under this Title, shall be regulated by a working arrangement as referred to in Article 594 concluded between Eurojust and the competent authorities of the United Kingdom. Article 594 Working arrangement The modalities of cooperation between the Parties as appropriate to implement this Title shall be the subject of a working arrangement concluded between Eurojust and the competent authorities of the United Kingdom in accordance with Articles 47(3) and 56(3) of the Eurojust Regulation. Article 595 Powers of Eurojust Nothing in this Title shall be construed as creating an obligation on Eurojust to cooperate with the competent authorities of the United Kingdom beyond Eurojust‘s competence as set out in the relevant Union law. TITLE VII SURRENDER Article 596 Objective The objective of this Title is to ensure that the extradition system between the Member States, on the one side, and the United Kingdom, on the other side, is based on a mechanism of surrender pursuant to an arrest warrant in accordance with the terms of this Title. Article 597 Principle of proportionality Cooperation through the arrest warrant shall be necessary and proportionate, taking into account the rights of the requested person and the interests of the victims, and having regard to the seriousness of the act, the likely penalty that would be imposed and the possibility of a State taking measures less coercive than the surrender of the requested person particularly with a view to avoiding unnecessarily long periods of pre-trial detention. Article 598 Definitions For the purposes of this Title, the following definitions apply: (a) "arrest warrant" means a judicial decision issued by a State with a view to the arrest and surrender by another State of a requested person, for the purposes of conducting a criminal prosecution or executing a custodial sentence or detention order; (b) "judicial authority" means an authority that is, under domestic law, a judge, a court or a public prosecutor. A public prosecutor is considered a judicial authority only to the extent that domestic law so provides; (c) "executing judicial authority" means the judicial authority of the executing State which is competent to execute the arrest warrant by virtue of the domestic law of that State; (d) "issuing judicial authority" means the judicial authority of the issuing State which is competent to issue an arrest warrant by virtue of the domestic law of that State. Article 599 Scope 1. An arrest warrant may be issued for acts punishable by the law of the issuing State by a custodial sentence or a detention order for a maximum period of at least 12 months or, where a sentence has been passed or a detention order has been made, for sentences or detention orders of at least four months. 2. Without prejudice to paragraphs 3 and 4, surrender is subject to the condition that the acts for which the arrest warrant has been issued constitute an offence under the law of the executing State, whatever the constituent elements or however it is described. 3. Subject to Article 600, points (b) to (h) of Article 601(1), and Articles 602, 603 and 604, a State shall not refuse to execute an arrest warrant issued in relation to the following behaviour where such behaviour is punishable by deprivation of liberty or a detention order of a maximum period of at least 12 months: (a) the behaviour of any person who contributes to the commission by a group of persons acting with a common purpose of one or more offences in the field of terrorism referred to in Articles 1 and 2 of the European Convention on the Suppression of Terrorism, done at Strasbourg on 27 January 1977, or in relation to illicit trafficking in narcotic drugs and psychotropic substances, or murder, grievous bodily injury, kidnapping, illegal restraint, hostage-taking or rape, even where that person does not take part in the actual execution of the offence or offences concerned; such contribution must be intentional and made with the knowledge that the participation will contribute to the achievement of the group's criminal activities; or (b) terrorism as defined in Annex 45. 4. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that, on the basis of reciprocity, the condition of double criminality referred to in paragraph 2 will not be applied, provided that the offence on which the warrant is based is: (a) one of the offences listed in paragraph 5, as defined by the law of the issuing State; and (b) punishable in the issuing State by a custodial sentence or a detention order for a maximum period of at least three years. 5. The offences referred to in paragraph 4 are: — participation in a criminal organisation; — terrorism as defined in Annex 45; — trafficking in human beings; — sexual exploitation of children and child pornography; — illicit trafficking in narcotic drugs and psychotropic substances; — illicit trafficking in weapons, munitions and explosives; — corruption, including bribery; — fraud, including that affecting the financial interests of the United Kingdom, a Member State or the Union; — laundering of the proceeds of crime; — counterfeiting currency; — computer-related crime; — environmental crime, including illicit trafficking in endangered animal species and endangered plant species and varieties; — facilitation of unauthorised entry and residence; — murder; — grievous bodily injury; — illicit trade in human organs and tissue; — kidnapping, illegal restraint and hostage-taking; — racism and xenophobia; — organised or armed robbery; — illicit trafficking in cultural goods, including antiques and works of art; — swindling; — racketeering and extortion; — counterfeiting and piracy of products; — forgery of administrative documents and trafficking therein; — forgery of means of payment; — illicit trafficking in hormonal substances and other growth promoters; — illicit trafficking in nuclear or radioactive materials; — trafficking in stolen vehicles; — rape; — arson; — crimes within the jurisdiction of the International Criminal Court; — unlawful seizure of aircraft, ships or spacecraft; and — sabotage. Article 600 Grounds for mandatory non-execution of the arrest warrant The execution of the arrest warrant shall be refused: (a) if the offence on which the arrest warrant is based is covered by an amnesty in the executing State, where that State had jurisdiction to prosecute the offence under its own criminal law; (b) if the executing judicial authority is informed that the requested person has been finally judged by a State in respect of the same acts, provided that, if a penalty has been imposed, it has been enforced, is in the process of being enforced or can no longer be enforced under the law of the sentencing State; or (c) if the person who is the subject of the arrest warrant may not, owing to the person's age, be held criminally responsible for the acts on which the arrest warrant is based under the law of the executing State. Article 601 Other grounds for non-execution of the arrest warrant 1. The execution of the arrest warrant may be refused: (a) if, in one of the cases referred to in Article 599(2), the act on which the arrest warrant is based does not constitute an offence under the law of the executing State; however, in relation to taxes or duties, customs and exchange, the execution of the arrest warrant shall not be refused on the grounds that the law of the executing State does not impose the same kind of tax or duty or does not contain the same type of rules as regards taxes or duties, customs and exchange regulations as the law of the issuing State; (b) if the person who is the subject of the arrest warrant is being prosecuted in the executing State for the same act as that on which the arrest warrant is based; (c) if the judicial authorities of the executing State have decided either not to prosecute for the offence on which the arrest warrant is based or to halt proceedings, or if a final judgment which prevents further proceedings has been passed upon the requested person in a State in respect of the same acts; (d) if the criminal prosecution or punishment of the requested person is statute-barred under the law of the executing State and the acts fall within the jurisdiction of that State under its own criminal law; (e) if the executing judicial authority is informed that the requested person has been finally judged by a third country in respect of the same acts provided that, if a penalty has been imposed, it has been enforced, is in the process of being enforced or can no longer be enforced under the law of the sentencing country; (f) if the arrest warrant has been issued for the purposes of execution of a custodial sentence or detention order and the requested person is staying in, or is a national or a resident of the executing State and that State undertakes to execute the sentence or detention order in accordance with its domestic law; if consent of the requested person to the transfer of the sentence or detention order to the executing State is required, the executing State may refuse to execute the arrest warrant only after the requested person consents to the transfer of the sentence or detention order; (g) if the arrest warrant relates to offences which: (i) are regarded by the law of the executing State as having been committed in whole or in part in the territory of the executing State or in a place treated as such; or (ii) have been committed outside the territory of the issuing State, and the law of the executing State does not allow prosecution for the same offences if committed outside its territory; (h) if there are reasons to believe on the basis of objective elements that the arrest warrant has been issued for the purpose of prosecuting or punishing a person on the grounds of the person's sex, race, religion, ethnic origin, nationality, language, political opinions or sexual orientation, or that that person's position may be prejudiced for any of those reasons; (i) if the arrest warrant has been issued for the purpose of executing a custodial sentence or a detention order and the requested person did not appear in person at the trial resulting in the decision, unless the arrest warrant states that the person, in accordance with further procedural requirements defined in the domestic law of the issuing State: (i) in due time: (A) either was summoned in person and thereby informed of the scheduled date and place of the trial which resulted in the decision, or by other means actually received official information of the scheduled date and place of that trial in such a manner that it was unequivocally established that the person was aware of the date and place of the scheduled trial ; and (B) was informed that a decision may be handed down if that person did not appear for the trial; or (ii) being aware of the date and place of the scheduled trial, had given a mandate to a lawyer, who was either appointed by the person concerned or by the State, to defend him or her at the trial, and was indeed defended by that lawyer at the trial; or (iii) after being served with the decision and being expressly informed about the right to a retrial or appeal in which the person has the right to participate and which allows the merits of the case, including fresh evidence, to be re-examined, and which may lead to the original decision being reversed: (A) expressly stated that the person did not contest the decision; or (B) did not request a retrial or appeal within the applicable time frame; or (iv) was not personally served with the decision but: (A) will be personally served with it without delay after the surrender and will be expressly informed of the right to a retrial or appeal in which the person has the right to participate and which allows the merits of the case, including fresh evidence, to be re-examined, and which may lead to the original decision being reversed; and (B) will be informed of the time frame within which the person has to request such a retrial or appeal, as mentioned in the relevant arrest warrant. 2. Where the arrest warrant is issued for the purpose of executing a custodial sentence or detention order under the conditions in point (i) (iv) of paragraph 1 and the person concerned has not previously received any official information about the existence of the criminal proceedings against him or her, that person may, when being informed about the content of the arrest warrant, request to receive a copy of the judgment before being surrendered. Immediately after having been informed about the request, the issuing authority shall provide the copy of the judgment via the executing authority to the person concerned. The request of the person concerned shall neither delay the surrender procedure nor delay the decision to execute the arrest warrant. The provision of the judgment to the person concerned shall be for information purposes only; it shall not be regarded as a formal service of the judgment nor actuate any time limits applicable for requesting a retrial or appeal. 3. Where a person is surrendered under the conditions in point (i) (iv) of paragraph 1 and that person has requested a retrial or appeal, until those proceedings are finalised the detention of that person awaiting such retrial or appeal shall be reviewed in accordance with the domestic law of the issuing State, either on a regular basis or upon request of the person concerned. Such a review shall in particular include the possibility of suspension or interruption of the detention. The retrial or appeal shall begin within due time after the surrender. Article 602 Political offence exception 1. The execution of an arrest warrant may not be refused on the grounds that the offence may be regarded by the executing State as a political offence, as an offence connected with a political offence or as an offence inspired by political motives. 2. However, the United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that paragraph 1 will be applied only in relation to: (a) the offences referred to in Articles 1 and 2 of the European Convention on the Suppression of Terrorism; (b) offences of conspiracy or association to commit one or more of the offences referred to in Articles 1 and 2 of the European Convention on the Suppression of Terrorism, if those offences of conspiracy or association correspond to the description of behaviour referred to in Article 599(3) of this Agreement; and (c) terrorism as defined in Annex 45 to this Agreement. 3. Where an arrest warrant has been issued by a State having made a notification as referred to in paragraph 2 or by a State on behalf of which such a notification has been made, the State executing the arrest warrant may apply reciprocity. Article 603 Nationality exception 1. The execution of an arrest warrant may not be refused on the grounds that the requested person is a national of the executing State. 2. The United Kingdom, and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that that State's own nationals will not be surrendered or that the surrender of their own nationals will be authorised only under certain specified conditions. The notification shall be based on reasons related to the fundamental principles or practice of the domestic legal order of the United Kingdom or the State on behalf of which a notification was made. In such a case, the Union, on behalf of any of its Member States or the United Kingdom, as the case may be, may notify the Specialised Committee on Law Enforcement and Judicial Cooperation within a reasonable time after the receipt of the other Party's notification that the executing judicial authorities of the Member State or the United Kingdom, as the case may be, may refuse to surrender its nationals to that State or that surrender shall be authorised only under certain specified conditions. 3. In circumstances where a State has refused to execute an arrest warrant on the basis that, in the case of the United Kingdom, it has made a notification or, in the case of a Member State, the Union has made a notification on its behalf, as referred to in paragraph 2, that State shall consider instituting proceedings against its own national which are commensurate with the subject matter of the arrest warrant, having taken into account the views of the issuing State. In circumstances where a judicial authority decides not to institute such proceedings, the victim of the offence on which the arrest warrant is based shall be able to receive information on the decision in accordance with the applicable domestic law. 4. Where a State's competent authorities institute proceedings against its own national in accordance with paragraph 3, that State shall ensure that its competent authorities are able to take appropriate measures to assist the victims and witnesses in circumstances where they are residents of another State, particularly with regard to the way in which the proceedings are conducted. Article 604 Guarantees to be given by the issuing State in particular cases The execution of the arrest warrant by the executing judicial authority may be subject to the following guarantees: (a) if the offence on which the arrest warrant is based is punishable by a custodial life sentence or a lifetime detention order in the issuing State, the executing State may make the execution of the arrest warrant subject to the condition that the issuing State gives a guarantee deemed sufficient by the executing State that the issuing State will review the penalty or measure imposed, on request or at the latest after 20 years, or will encourage the application of measures of clemency for which the person is entitled to apply under the law or practice of the issuing State, aiming at the non-execution of such penalty or measure; (b) if a person who is the subject of an arrest warrant for the purposes of prosecution is a national or resident of the executing State, the surrender of that person may be subject to the condition that the person, after being heard, is returned to the executing State in order to serve there the custodial sentence or detention order passed against him or her in the issuing State; if the consent of the requested person to the transfer of the sentence or detention order to the executing State is required, the guarantee that the person be returned to the executing State to serve the person's sentence is subject to the condition that the requested person, after being heard, consents to be returned to the executing State; (c) if there are substantial grounds for believing that there is a real risk to the protection of the fundamental rights of the requested person, the executing judicial authority may require, as appropriate, additional guarantees as to the treatment of the requested person after the person's surrender before it decides whether to execute the arrest warrant. Article 605 Recourse to the central authority 1. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation of, in the case of the United Kingdom, its central authority and, in the case of the Union, the central authority for each State, having designated such an authority, or, if the legal system of the relevant State so provides, of more than one central authority to assist the competent judicial authorities. 2. When notifying the Specialised Committee on Law Enforcement and Judicial Cooperation under paragraph 1, the United Kingdom and the Union, acting on behalf of any of its Member States, may each indicate that, as a result of the organisation of the internal judicial system of the relevant States, the central authority or central authorities are responsible for the administrative transmission and receipt of arrest warrants as well as for all other official correspondence relating to the administrative transmission and receipt of arrest warrants. Such indication shall be binding upon all the authorities of the issuing State. Article 606 Content and form of the arrest warrant 1. The arrest warrant shall contain the following information set out in accordance with the form contained in Annex 43: (a) the identity and nationality of the requested person; (b) the name, address, telephone and fax numbers and e-mail address of the issuing judicial authority; (c) evidence of an enforceable judgment, an arrest warrant or any other enforceable judicial decision having the same effect that fall within the scope of Article 599; (d) the nature and legal classification of the offence, particularly in respect of Article 599; (e) a description of the circumstances in which the offence was committed, including the time, place and degree of participation in the offence by the requested person; (f) the penalty imposed, if there is a final judgment, or the prescribed scale of penalties for the offence under the law of the issuing State; and (g) if possible, other consequences of the offence. 2. The arrest warrant shall be translated into the official language or one of the official languages of the executing State. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that a translation in one or more other official languages of a State will be accepted. Article 607 Transmission of an arrest warrant If the location of the requested person is known, the issuing judicial authority may transmit the arrest warrant directly to the executing judicial authority. Article 608 Detailed procedures for transmitting an arrest warrant 1. If the issuing judicial authority does not know which authority is the competent executing judicial authority, it shall make the requisite enquiries, in order to obtain that information from the executing State. 2. The issuing judicial authority may request the International Criminal Police Organisation ("Interpol") to transmit an arrest warrant. 3. The issuing judicial authority may transmit the arrest warrant by any secure means capable of producing written records under conditions allowing the executing State to establish the authenticity of the arrest warrant. 4. All difficulties concerning the transmission or the authenticity of any document needed for the execution of the arrest warrant shall be dealt with by direct contacts between the judicial authorities involved, or, where appropriate, with the involvement of the central authorities of the States. 5. If the authority which receives an arrest warrant is not competent to act upon it, it shall automatically forward the arrest warrant to the competent authority in its State and shall inform the issuing judicial authority accordingly. Article 609 Rights of a requested person 1. If a requested person is arrested for the purpose of the execution of an arrest warrant, the executing judicial authority, in accordance with its domestic law, shall inform that person of the arrest warrant and of its contents, and also of the possibility of consenting to surrender to the issuing State. 2. A requested person who is arrested for the purpose of the execution of an arrest warrant and who does not speak or understand the language of the arrest warrant proceedings shall have the right to be assisted by an interpreter and to be provided with a written translation in the native language of the requested person or in any other language which that person speaks or understands, in accordance with the domestic law of the executing State. 3. A requested person shall have the right to be assisted by a lawyer in accordance with the domestic law of the executing State upon arrest. 4. The requested person shall be informed of the person's right to appoint a lawyer in the issuing State for the purpose of assisting the lawyer in the executing State in the arrest warrant proceedings. This paragraph is without prejudice to the time limits set out in Article 621. 5. A requested person who is arrested shall have the right to have the consular authorities of that person's State of nationality, or if that person is stateless, the consular authorities of the State where that person usually resides, informed of the arrest without undue delay and to communicate with those authorities, if that person so wishes. Article 610 Keeping the person in detention When a person is arrested on the basis of an arrest warrant, the executing judicial authority shall take a decision on whether the requested person should remain in detention, in accordance with the law of the executing State. The person may be released provisionally at any time in accordance with the domestic law of the executing State, provided that the competent authority of that State takes all the measures it deems necessary to prevent the person from absconding. Article 611 Consent to surrender 1. If the arrested person indicates that he or she consents to surrender, that consent and, if appropriate, the express renunciation of entitlement to the speciality rule referred to in Article 625(2) must be given before the executing judicial authority, in accordance with the domestic law of the executing State. 2. Each State shall adopt the measures necessary to ensure that the consent and, where appropriate, the renunciation referred to in paragraph 1 are established in such a way as to show that the person concerned has expressed them voluntarily and in full awareness of the consequences. To that end, the requested person shall have the right to a lawyer. 3. The consent and, where appropriate, the renunciation referred to in paragraph 1 shall be formally recorded in accordance with the procedure laid down by the domestic law of the executing State. 4. In principle, consent may not be revoked. Each State may provide that the consent and, if appropriate, the renunciation referred to in paragraph 1 of this Article may be revoked in accordance with the rules applicable under its domestic law. In such a case, the period between the date of the consent and that of its revocation shall not be taken into consideration in establishing the time limits laid down in Article 621. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that it wishes to have recourse to this possibility, specifying the procedures whereby revocation of the consent is possible and any amendments to those procedures. Article 612 Hearing of the requested person Where the arrested person does not consent to surrender as referred to in Article 611, that person shall be entitled to be heard by the executing judicial authority, in accordance with the law of the executing State. Article 613 Surrender decision 1. The executing judicial authority shall decide whether the person is to be surrendered within the time limits and in accordance with the conditions defined in this Title, in particular the principle of proportionality as set out in Article 597. 2. If the executing judicial authority finds the information communicated by the issuing State to be insufficient to allow it to decide on surrender, it shall request that the necessary supplementary information, in particular with respect to Article 597, Articles 600 to 602, Article 604 and Article 606, be furnished as a matter of urgency and may fix a time limit for the receipt thereof, taking into account the need to observe the time limits provided for in Article 615. 3. The issuing judicial authority may forward any additional useful information to the executing judicial authority at any time. Article 614 Decision in the event of multiple requests 1. If two or more States have issued a European arrest warrant or an arrest warrant for the same person, the decision as to which of those arrest warrants is to be executed shall be taken by the executing judicial authority, with due consideration of all the circumstances, especially the relative seriousness of the offences and place of the offences, the respective dates of the arrest warrants or European arrest warrants and whether they have been issued for the purposes of prosecution or for the execution of a custodial sentence or detention order, and of legal obligations of Member States deriving from Union law regarding, in particular, the principles of freedom of movement and non-discrimination on grounds of nationality. 2. The executing judicial authority of a Member State may seek the advice of Eurojust when making the choice referred to in paragraph 1. 3. In the event of a conflict between an arrest warrant and a request for extradition presented by a third country, the decision as to whether the arrest warrant or the extradition request takes precedence shall be taken by the competent authority of the executing State with due consideration of all the circumstances, in particular those referred to in paragraph 1 and those mentioned in the applicable convention. 4. This Article is without prejudice to the States' obligations under the Statute of the International Criminal Court. Article 615 Time limits and procedures for the decision to execute the arrest warrant 1. An arrest warrant shall be dealt with and executed as a matter of urgency. 2. In cases where the requested person consents to surrender, the final decision on the execution of the arrest warrant shall be taken within ten days after the consent was given. 3. In other cases, the final decision on the execution of the arrest warrant shall be taken within 60 days after the arrest of the requested person. 4. Where in specific cases the arrest warrant cannot be executed within the time limits laid down in paragraph 2 or 3, the executing judicial authority shall immediately inform the issuing judicial authority of that fact, giving the reasons for the delay. In such cases, the time limits may be extended by a further 30 days. 5. As long as the executing judicial authority has not taken a final decision on the arrest warrant, it shall ensure that the material conditions necessary for the effective surrender of the person remain fulfilled. 6. Reasons must be given for any refusal to execute an arrest warrant. Article 616 Situation pending the decision 1. Where the arrest warrant has been issued for the purpose of conducting a criminal prosecution, the executing judicial authority shall either: (a) agree that the requested person should be heard according to Article 617; or (b) agree to the temporary transfer of the requested person. 2. The conditions and the duration of the temporary transfer shall be determined by mutual agreement between the issuing and executing judicial authorities. 3. In the case of temporary transfer, the person must be able to return to the executing State to attend hearings which concern that person as part of the surrender procedure. Article 617 Hearing the person pending the decision 1. The requested person shall be heard by a judicial authority. To that end, the requested person shall be assisted by a lawyer designated in accordance with the law of the issuing State. 2. The requested person shall be heard in accordance with the law of the executing State and with the conditions determined by mutual agreement between the issuing and executing judicial authorities. 3. The competent executing judicial authority may assign another judicial authority of its State to take part in the hearing of the requested person in order to ensure the proper application of this Article. Article 618 Privileges and immunities 1. Where the requested person enjoys a privilege or immunity regarding jurisdiction or execution in the executing State, the time limits referred to in Article 615 only start running when, or if, the executing judicial authority is informed of the fact that the privilege or immunity has been waived. 2. The executing State shall ensure that the material conditions necessary for effective surrender are fulfilled when the person no longer enjoys such privilege or immunity. 3. Where power to waive the privilege or immunity lies with an authority of the executing State, the executing judicial authority shall request that authority to exercise that power without delay. Where power to waive the privilege or immunity lies with an authority of another State, third country or international organisation, the issuing judicial authority shall request that authority to exercise that power. Article 619 Competing international obligations 1. This Agreement does not prejudice the obligations of the executing State where the requested person has been extradited to that State from a third country and where that person is protected by provisions of the arrangement under which that person was extradited concerning the speciality rule. The executing State shall take all necessary measures for requesting without delay the consent of the third country from which the requested person was extradited so that the requested person can be surrendered to the State which issued the arrest warrant. The time limits referred to in Article 615 do not start running until the day on which the speciality rule ceases to apply. 2. Pending the decision of the third country from which the requested person was extradited, the executing State shall ensure that the material conditions necessary for effective surrender remain fulfilled. Article 620 Notification of the decision The executing judicial authority shall notify the issuing judicial authority immediately of the decision on the action to be taken on the arrest warrant. Article 621 Time limits for surrender of the person 1. The requested person shall be surrendered as soon as possible on a date agreed between the authorities concerned. 2. The requested person shall be surrendered no later than ten days after the final decision on the execution of the arrest warrant. 3. If the surrender of the requested person within the time limit in paragraph 2 is prevented by circumstances beyond the control of any of the States, the executing and issuing judicial authorities shall immediately contact each other and agree on a new surrender date. In that event, the surrender shall take place within ten days of the new date thus agreed. 4. The surrender may exceptionally be temporarily postponed for serious humanitarian reasons, for example if there are substantial grounds for believing that the surrender would manifestly endanger the requested person's life or health. The execution of the arrest warrant shall take place as soon as those grounds have ceased to exist. The executing judicial authority shall immediately inform the issuing judicial authority and agree on a new surrender date. In that event, the surrender shall take place within ten days of the new date agreed. 5. Upon the expiry of the time limits referred to in paragraphs 2 to 4, if the requested person is still being held in custody, that person shall be released. The executing and issuing judicial authorities shall contact each other as soon as it appears that a person is to be released under this paragraph and agree the arrangements for the surrender of that person. Article 622 Postponed or conditional surrender 1. After deciding to execute the arrest warrant, the executing judicial authority may postpone the surrender of the requested person so that the requested person may be prosecuted in the executing State or, if the requested person has already been sentenced, so that the requested person may serve, a sentence passed for an act other than that referred to in the arrest warrant in the territory of the executing State. 2. Instead of postponing the surrender, the executing judicial authority may temporarily surrender the requested person to the issuing State under conditions to be determined by mutual agreement between the executing and the issuing judicial authorities. The agreement shall be made in writing and the conditions shall be binding on all the authorities in the issuing State. Article 623 Transit 1. Each State shall permit the transit through its territory of a requested person who is being surrendered provided that it has been given information on: (a) the identity and nationality of the person subject to the arrest warrant; (b) the existence of an arrest warrant; (c) the nature and legal classification of the offence; and (d) the description of the circumstances of the offence, including the date and place. 2. The State, on behalf of which a notification has been made in accordance with Article 603(2) to the effect that its own nationals will not be surrendered or that surrender will be authorised only under certain specified conditions, may, refuse the transit of its own nationals through its territory under the same terms or submit it to the same conditions. 3. The States shall designate an authority responsible for receiving transit requests and the necessary documents, as well as any other official correspondence relating to transit requests. 4. The transit request and the information referred to in paragraph 1 may be addressed to the authority designated pursuant to paragraph 3 by any means capable of producing a written record. The State of transit shall notify its decision by the same procedure. 5. This Article does not apply in the case of transport by air without a scheduled stopover. However, if an unscheduled landing occurs, the issuing State shall provide the authority designated pursuant to paragraph 3 with the information referred to in paragraph 1. 6. Where a transit concerns a person who is to be extradited from a third country to a State, this Article applies mutatis mutandis. In particular, references to an "arrest warrant" shall be treated as references to an "extradition request". Article 624 Deduction of the period of detention served in the executing State 1. The issuing State shall deduct all periods of detention arising from the execution of an arrest warrant from the total period of detention to be served in the issuing State as a result of a custodial sentence or detention order being passed. 2. All information concerning the duration of the detention of the requested person on the basis of the arrest warrant shall be transmitted by the executing judicial authority or the central authority designated under Article 605 to the issuing judicial authority at the time of the surrender. Article 625 Possible prosecution for other offences 1. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that, in relations with other States to which the same notification applies, consent is presumed to have been given for the prosecution, sentencing or detention of a person with a view to the carrying out of a custodial sentence or detention order for an offence committed prior to the person's surrender, other than that for which that person was surrendered, unless in a particular case the executing judicial authority states otherwise in its decision on surrender. 2. Except in the cases referred to in paragraphs 1 and 3, a person surrendered may not be prosecuted, sentenced or otherwise deprived of liberty for an offence committed prior to that person's surrender other than that for which the person was surrendered. 3. Paragraph 2 of this Article does not apply in the following cases: (a) the person, having had an opportunity to leave the territory of the State to which that person has been surrendered, has not done so within 45 days of that person's final discharge or has returned to that territory after leaving it; (b) the offence is not punishable by a custodial sentence or detention order; (c) the criminal proceedings do not give rise to the application of a measure restricting personal liberty; (d) the person could be liable to a penalty or a measure not involving the deprivation of liberty, in particular a financial penalty or a measure in lieu of a financial penalty, even if the penalty or measure may give rise to a restriction of the person's personal liberty; (e) the person consented to be surrendered, where appropriate at the same time as the person renounced the speciality rule, in accordance with Article 611; (f) the person, after the person's surrender, has expressly renounced entitlement to the speciality rule with regard to specific offences preceding the person's surrender; renunciation must be given before the competent judicial authority of the issuing State and be recorded in accordance with that State's domestic law; the renunciation must be drawn up in such a way as to make clear that the person concerned has given it voluntarily and in full awareness of the consequences; to that end, the person shall have the right to a lawyer; and (g) the executing judicial authority which surrendered the person gives its consent in accordance with paragraph 4 of this Article. 4. A request for consent shall be submitted to the executing judicial authority, accompanied by the information referred to in Article 606(1) and a translation as referred to in Article 606(2). Consent shall be given where the offence for which it is requested is itself subject to surrender in accordance with the provisions of this Title. Consent shall be refused on the grounds referred to in Article 600 and otherwise may be refused only on the grounds referred to in Article 601, or Article 602(2) and Article 603(2). The decision shall be taken no later than 30 days after receipt of the request. For the situations laid down in Article 604 the issuing State must give the guarantees provided for therein. Article 626 Surrender or subsequent extradition 1. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that, in relations with other States to which the same notification applies, the consent for the surrender of a person to a State other than the executing State pursuant to an arrest warrant or European arrest warrant issued for an offence committed prior to that person's surrender is presumed to have been given, unless in a particular case the executing judicial authority states otherwise in its decision on surrender. 2. In any case, a person who has been surrendered to the issuing State pursuant to an arrest warrant or European arrest warrant may be surrendered to a State other than the executing State pursuant to an arrest warrant or European arrest warrant issued for any offence committed prior to the person's surrender without the consent of the executing State in the following cases: (a) the requested person, having had an opportunity to leave the territory of the State to which that person has been surrendered, has not done so within 45 days of that person's final discharge, or has returned to that territory after leaving it; (b) the requested person consents to be surrendered to a State other than the executing State pursuant to an arrest warrant or European arrest warrant; consent must be given before the competent judicial authorities of the issuing State and be recorded in accordance with that State's domestic law; it must be drawn up in such a way as to make clear that the person concerned has given it voluntarily and in full awareness of the consequences; to that end, the requested person shall have the right to a lawyer; and (c) the requested person is not subject to the speciality rule, in accordance with point (a), (e), (f) or (g) of Article 625(3). 3. The executing judicial authority shall consent to the surrender to another State in accordance with the following rules: (a) the request for consent shall be submitted in accordance with Article 607, accompanied by the information set out in Article 606(1) and a translation as referred to in Article 606(2); (b) consent shall be given where the offence for which it is requested is itself subject to surrender in accordance with the provisions of this Agreement; (c) the decision shall be taken no later than 30 days after receipt of the request; and (d) consent shall be refused on the grounds referred to in Article 600 and otherwise may be refused only on the grounds referred to in Article 601, Article 602(2) and Article 603(2). 4. For the situations referred to in Article 604, the issuing State shall give the guarantees provided for therein. 5. Notwithstanding paragraph 1, a person who has been surrendered pursuant to an arrest warrant shall not be extradited to a third country without the consent of the competent authority of the State which surrendered the person. Such consent shall be given in accordance with the Conventions by which that State is bound, as well as with its domestic law. Article 627 Handing over of property 1. At the request of the issuing judicial authority or on its own initiative, the executing judicial authority shall, in accordance with its domestic law, seize and hand over property which: (a) may be required as evidence; or (b) has been acquired by the requested person as a result of the offence. 2. The property referred to in paragraph 1 shall be handed over even if the arrest warrant cannot be carried out owing to the death or escape of the requested person. 3. If the property referred to in paragraph 1 is liable to seizure or confiscation in the territory of the executing State, that State may, if the property is needed in connection with pending criminal proceedings, temporarily retain it or hand it over to the issuing State on condition that it is returned. 4. Any rights which the executing State or third parties may have acquired in the property referred to in paragraph 1 shall be preserved. Where such rights exist, the issuing State shall return the property without charge to the executing State as soon as the criminal proceedings have been terminated. Article 628 Expenses 1. Expenses incurred in the territory of the executing State for the execution of an arrest warrant shall be borne by that State. 2. All other expenses shall be borne by the issuing State. Article 629 Relation to other legal instruments 1. Without prejudice to their application in relations between States and third countries, this Title, from the date of entry into force of this Agreement, replaces the corresponding provisions of the following conventions applicable in the field of extradition in relations between the United Kingdom, on the one side, and Member States, on the other side: (a) the European Convention on Extradition, done at Paris on 13 December 1957, and its additional protocols; and (b) the European Convention on the Suppression of Terrorism, as far as extradition is concerned. 2. Where the Conventions referred to in paragraph 1 apply to the territories of States or to territories for whose external relations a State is responsible to which this Title does not apply, those Conventions continue to govern the relations existing between those territories and the other States. Article 630 Review of notifications When carrying out the joint review of this Title as referred to in Article 691(1), the Parties shall consider the need to maintain the notifications made under Article 599(4), Article 602(2) and Article 603(2). If the notifications referred to in Article 603(2) are not renewed, they shall expire five years after the date of entry into force of this Agreement. Notifications as referred to in Article 603(2) may only be renewed or newly made during the three months prior to the fifth anniversary of the entry into force of this Agreement and, subsequently, every five years thereafter, provided that the conditions set out in Article 603(2) are met at that time. Article 631 Ongoing arrest warrants in case of disapplication Notwithstanding Article 526, Article 692 and Article 693, the provisions of this Title apply in respect of arrest warrants where the requested person was arrested before the disapplication of this Title for the purposes of the execution of an arrest warrant, irrespective of the decision of the executing judicial authority as to whether the requested person is to remain in detention or be provisionally released. Article 632 Application to existing European arrest warrants This Title shall apply in respect of European arrest warrants issued in accordance with Council Framework Decision 2002/584/JHA (81) by a State before the end of the transition period where the requested person has not been arrested for the purpose of its execution before the end of the transition period. TITLE VIII MUTUAL ASSISTANCE Article 633 Objective 1. The objective of this Title is to supplement the provisions, and facilitate the application between Member States, on the one side, and the United Kingdom, on the other side, of: (a) the European Convention on Mutual Assistance in Criminal Matters, done at Strasbourg on 20 April 1959 (the "European Mutual Assistance Convention"); (b) the Additional Protocol to the European Mutual Assistance Convention, done at Strasbourg on 17 March 1978; and (c) the Second Additional Protocol to the European Mutual Assistance Convention, done at Strasbourg on 8 November 2001. 2. This Title is without prejudice to the provisions of Title IX, which takes precedence over this Title. Article 634 Definition of competent authority For the purposes of this Title, "competent authority" means any authority which is competent to send or receive requests for mutual assistance in accordance with the provisions of the European Mutual Assistance Convention and its Protocols and as defined by States in their respective declarations addressed to the Secretary General of the Council of Europe. "Competent authority" also includes Union bodies notified in accordance with point (d) of Article 690; with regard to such Union bodies, the provisions of this Title apply accordingly. Article 635 Form for a request for mutual assistance 1. The Specialised Committee on Law Enforcement and Judicial Cooperation shall undertake to establish a standard form for requests for mutual assistance by adopting an annex to this Agreement. 2. If the Specialised Committee on Law Enforcement and Judicial Cooperation has adopted a decision in accordance with paragraph 1, requests for mutual assistance shall be made using the standard form. 3. The Specialised Committee on Law Enforcement and Judicial Cooperation may amend the standard form for requests for mutual assistance as may be necessary. Article 636 Conditions for a request for mutual assistance 1. The competent authority of the requesting State may only make a request for mutual assistance if it is satisfied that the following conditions are met: (a) the request is necessary and proportionate for the purpose of the proceedings, taking into account the rights of the suspected or accused person; and (b) the investigative measure or investigative measures indicated in the request could have been ordered under the same conditions in a similar domestic case. 2. The requested State may consult the requesting State if the competent authority of the requested State is of the view that the conditions in paragraph 1 are not met. After the consultation, the competent authority of the requesting State may decide to withdraw the request for mutual assistance. Article 637 Recourse to a different type of investigative measure 1. Wherever possible, the competent authority of the requested State shall consider recourse to an investigative measure other than the measure indicated in the request for mutual assistance if: (a) the investigative measure indicated in the request does not exist under the law of the requested State; or (b) the investigative measure indicated in the request would not be available in a similar domestic case. 2. Without prejudice to the grounds for refusal available under the European Mutual Assistance Convention and its Protocols and under Article 639, paragraph 1 of this Article does not apply to the following investigative measures, which shall always be available under the law of the requested State: (a) the obtaining of information contained in databases held by police or judicial authorities that is directly accessible by the competent authority of the requested State in the framework of criminal proceedings; (b) the hearing of a witness, expert, victim, suspected or accused person or third party in the territory of the requested State; (c) any non-coercive investigative measure as defined under the law of the requested State; and (d) the identification of persons holding a subscription to a specified phone number or IP address. 3. The competent authority of the requested State may also have recourse to an investigative measure other than the measure indicated in the request for mutual assistance if the investigative measure selected by the competent authority of the requested State would achieve the same result by less intrusive means than the investigative measure indicated in the request. 4. If the competent authority of the requested State decides to have recourse to a measure other than that indicated in the request for mutual assistance as referred to in paragraph 1 or 3, it shall first inform the competent authority of the requesting State, which may decide to withdraw or supplement the request. 5. If the investigative measure indicated in the request does not exist under the law of the requested State or would not be available in a similar domestic case, and there is no other investigative measure which would have the same result as the investigative measure requested, the competent authority of the requested State shall inform the competent authority of the requesting State that it is not possible to provide the assistance requested. Article 638 Obligation to inform The competent authority of the requested State shall inform the competent authority of the requesting State by any means and without undue delay if: (a) it is impossible to execute the request for mutual assistance due to the fact that the request is incomplete or manifestly incorrect; or (b) the competent authority of the requested State, in the course of the execution of the request for mutual assistance, considers without further enquiries that it may be appropriate to carry out investigative measures not initially foreseen, or which could not be specified when the request for mutual assistance was made, in order to enable the competent authority of the requesting State to take further action in the specific case. Article 639 Ne bis in idem Mutual assistance may be refused, in addition to the grounds for refusal provided for under the European Mutual Assistance Convention and its Protocols, on the ground that the person in respect of whom the assistance is requested and who is subject to criminal investigations, prosecutions or other proceedings, including judicial proceedings, in the requesting State, has been finally judged by another State in respect of the same acts, provided that, if a penalty has been imposed, it has been enforced, is in the process of being enforced or can no longer be enforced under the law of the sentencing State. Article 640 Time limits 1. The requested State shall decide whether to execute the request for mutual assistance as soon as possible and in any event no later than 45 days after the receipt of the request and shall inform the requesting State of its decision. 2. A request for mutual assistance shall be executed as soon as possible and in any event no later than 90 days after the decision referred to in paragraph 1 of this Article or after the consultation referred to in Article 636(2) has taken place. 3. If it is indicated in the request for mutual assistance that, due to procedural deadlines, the seriousness of the offence or other particularly urgent circumstances, a shorter time limit than that provided for in paragraph 1 or 2 is necessary, or if it is indicated in the request that a measure for mutual assistance is to be carried out on a specific date, the requested State shall take as full account as possible of that requirement. 4. If a request for mutual assistance is made to take provisional measures pursuant to Article 24 of the Second Additional Protocol to the European Mutual Assistance Convention, the competent authority of the requested State shall decide on the provisional measure, and shall communicate that decision to the competent authority of the requesting State, as soon as possible after the receipt of the request. Before lifting any provisional measure taken pursuant to this Article, the competent authority of the requested State, wherever possible, shall give the competent authority of the requesting State an opportunity to present its reasons in favour of continuing the measure. 5. If in a specific case, the time limit provided for in paragraph 1 or 2, or the time limit or specific date referred to in paragraph 3 cannot be met, or the decision on taking provisional measures in accordance with paragraph 4 is delayed, the competent authority of the requested State shall, without delay, inform the competent authority of the requesting State by any means, giving the reasons for the delay, and shall consult with the competent authority of the requesting State on the appropriate timing to execute the request for mutual assistance. 6. The time limits referred to in this Article do not apply if the request for mutual assistance is made in relation to any of the following offences and infringements that fall within scope of the European Mutual Assistance Convention and its Protocols, as defined in the law of the requesting State: (a) speeding, if no injury or death was caused to another person and if the excess speed was not significant; (b) failure to wear a seatbelt; (c) failure to stop at a red light or other mandatory stop signal; (d) failure to wear a safety helmet; or (e) using a forbidden lane (such as the forbidden use of an emergency lane, a lane reserved for public transport, or a lane closed down for road works). 7. The Specialised Committee on Law Enforcement and Judicial Cooperation shall keep the operation of paragraph 6 under review. It shall undertake to set time limits for the requests to which paragraph 6 applies within three years of the entry into force of this Agreement, taking into account the volume of requests. It may also decide that paragraph 6 shall no longer apply. Article 641 Transmission of requests for mutual assistance 1. In addition to the channels of communication provided for under the European Mutual Assistance Convention and its Protocols, if direct transmission is provided for under their respective provisions, requests for mutual assistance may also be transmitted directly by public prosecutors in the United Kingdom to competent authorities of the Member States. 2. In addition to the channels of communication provided for under the European Mutual Assistance Convention and its Protocols, in urgent cases, any request for mutual assistance, as well as spontaneous information, may be transmitted via Europol or Eurojust, in line with the provisions in the respective Titles of this Agreement. Article 642 Joint Investigation Teams If the competent authorities of States set up a Joint Investigation Team, the relationship between Member States within the Joint Investigation Team shall be governed by Union law, notwithstanding the legal basis referred to in the Agreement on the setting up of the Joint Investigation Team. TITLE IX EXCHANGE OF CRIMINAL RECORD INFORMATION Article 643 Objective 1. The objective of this Title is to enable the exchange between the Members States, on the one side, and the United Kingdom, on the other side, of information extracted from the criminal record. 2. In the relations between the United Kingdom and the Member States, the provisions of this Title: (a) supplement Articles 13 and 22(2) of the European Convention on Mutual Assistance in Criminal Matters and its Additional Protocols of 17 March 1978 and 8 November 2001; and (b) replace Article 22(1) of the European Convention on Mutual Assistance in Criminal Matters, as supplemented by Article 4 of its Additional Protocol of 17 March 1978. 3. In the relations between a Member State, on the one side, and the United Kingdom, on the other side, each shall waive the right to rely on its reservations to Article 13 of the European Convention on Mutual Assistance in Criminal Matters and to Article 4 of its Additional Protocol of 17 March 1978. Article 644 Definitions For the purposes of this Title, the following definitions apply: (a) "conviction" means any final decision of a criminal court against a natural person in respect of a criminal offence, to the extent that the decision is entered in the criminal record of the convicting State; (b) "criminal proceedings" means the pre-trial stage, the trial stage and the execution of a conviction; (c) "criminal record" means the domestic register or registers recording convictions in accordance with domestic law. Article 645 Central authorities Each State shall designate one or more central authorities that shall be competent for the exchange of information extracted from the criminal record pursuant to this Title and for the exchanges referred to in Article 22(2) of the European Convention on Mutual Assistance in Criminal Matters. Article 646 Notifications 1. Each State shall take the necessary measures to ensure that all convictions handed down within its territory are accompanied, when provided to its criminal record, by information on the nationality or nationalities of the convicted person if that person is a national of another State. 2. The central authority of each State shall inform the central authority of any other State of all criminal convictions handed down within its territory in respect of nationals of the latter State, as well as of any subsequent alterations or deletions of information contained in the criminal record, as entered in the criminal record. The central authorities of the States shall communicate such information to each other at least once per month. 3. If the central authority of a State becomes aware of the fact that a convicted person is a national of two or more other States, it shall transmit the relevant information to each of those States, even if the convicted person is a national of the State within whose territory that person was convicted. Article 647 Storage of convictions 1. The central authority of each State shall store all information notified under Article 646. 2. The central authority of each State shall ensure that if a subsequent alteration or deletion is notified under Article 646(2), an identical alteration or deletion is made to the information stored in accordance with paragraph 1 of this Article. 3. The central authority of each State shall ensure that only information which has been updated in accordance with paragraph 2 of this Article is provided when replying to requests made under Article 648. Article 648 Requests for information 1. If information from the criminal record of a State is requested at domestic level for the purposes of criminal proceedings against a person or for any purposes other than that of criminal proceedings, the central authority of that State may, in accordance with its domestic law, submit a request to the central authority of another State for information and related data to be extracted from the criminal record. 2. If a person asks the central authority of a State other than the State of the person's nationality for information on the person's own criminal record, that central authority shall submit a request to the central authority of the State of the person's nationality for information and related data to be extracted from the criminal record in order to be able to include that information and related data in the extract to be provided to the person concerned. Article 649 Replies to requests 1. Replies to requests for information shall be transmitted by the central authority of the requested State to the central authority of the requesting State as soon as possible and in any event within 20 working days from the date the request was received. 2. The central authority of each State shall reply to requests made for purposes other than that of criminal proceedings in accordance with its domestic law. 3. Notwithstanding paragraph 2, when replying to requests made for the purposes of recruitment for professional or organised voluntary activities involving direct and regular contacts with children, the States shall include information on the existence of criminal convictions for offences related to sexual abuse or sexual exploitation of children, child pornography, solicitation of children for sexual purposes, including inciting, aiding and abetting or attempting to commit any of those offences, as well as information on the existence of any disqualification from exercising activities involving direct and regular contacts with children arising from those criminal convictions. Article 650 Channel of communication The exchange between States of information extracted from the criminal record shall take place electronically in accordance with the technical and procedural specifications laid down in Annex 44. Article 651 Conditions for the use of personal data 1. Each State may use personal data received in reply to its request under Article 649 only for the purposes for which they were requested. 2. If the information was requested for any purposes other than that of criminal proceedings, personal data received under Article 649 may be used by the requesting State in accordance with its domestic law only within the limits specified by the requested State in the form set out in Chapter 2 of Annex 44. 3. Notwithstanding paragraphs 1 and 2 of this Article, personal data provided by a State in reply to a request under Article 649 may be used by the requesting State to prevent an immediate and serious threat to public security. 4. Each State shall ensure that their central authorities do not disclose personal data notified under Article 646 to authorities in third countries unless the following conditions are met: (a) the personal data are disclosed only on a case-by-case basis; (b) the personal data are disclosed to authorities whose functions are directly related to the purposes for which the personal data are disclosed under point (c) of this paragraph; (c) the personal data are disclosed only if necessary: (i) for the purposes of criminal proceedings; (ii) for any purposes other than that of criminal proceedings; or (iii) to prevent an immediate and serious threat to public security; (d) the personal data may be used by the requesting third country only for the purposes for which the information was requested and within the limits specified by the State that notified the personal data under Article 646; and (e) the personal data are disclosed only if the central authority, having assessed all the circumstances surrounding the transfer of the personal data to the third country, concludes that appropriate safeguards exist to protect the personal data. 2. This Article does not apply to personal data obtained by a State under this Title and originating from that State. TITLE X ANTI-MONEY LAUNDERING AND COUNTER TERRORIST FINANCING Article 652 Objective The objective of this Title is to support and strengthen action by the Union and the United Kingdom to prevent and combat money laundering and terrorist financing. Article 653 Measures to prevent and combat money laundering and terrorist financing 1. The Parties agree to support international efforts to prevent and combat money laundering and terrorist financing. The Parties recognise the need to cooperate in preventing the use of their financial systems to launder the proceeds of all criminal activity, including drug trafficking and corruption, and to combat terrorist financing. 2. The Parties shall exchange relevant information, as appropriate within their respective legal frameworks. 3. The Parties shall each maintain a comprehensive regime to combat money laundering and terrorist financing, and regularly review the need to enhance that regime, taking account of the principles and objectives of the Financial Action Task Force Recommendations. Article 654 Beneficial ownership transparency for corporate and other legal entities 1. For the purposes of this Article, the following definitions apply: (a) "beneficial owner" means any individual in respect of a corporate entity who, in accordance with the Party's laws and regulations: (i) exercises or has the right to exercise ultimate control over the management of the entity; (ii) ultimately owns or controls directly or indirectly more than 25 % of the voting rights or shares or other ownership interests in the entity, without prejudice to each Party's right to define a lower percentage; or (iii) otherwise controls or has the right to control the entity; In respect of legal entities such as foundations, Anstalt and limited liability partnerships, each Party has the right to determine similar criteria for identifying the beneficial owner, or, if they choose, to apply the definition set out in point (a) of Article 655(1), having regard to the form and structure of such entities. In respect of other legal entities not mentioned above, each Party shall take into account the different forms and structures of such entities and the levels of money laundering and terrorist financing risks associated with such entities, with a view to deciding the appropriate levels of beneficial ownership transparency; (b) "basic information about a beneficial owner" means the beneficial owner's name, month and year of birth, country of residence and nationality, as well as the nature and extent of the interest held, or control exercised, over the entity by the beneficial owner; (c) "competent authorities" means: (i) public authorities, including Financial Intelligence Units, that have designated responsibilities for combating money laundering or terrorist financing; (ii) public authorities that have the function of investigating or prosecuting money laundering, associated predicate offences or terrorist financing, or that have the function of tracing, seizing or freezing and confiscating criminal assets; (iii) public authorities that have supervisory or monitoring responsibilities aimed at ensuring compliance with anti-money laundering or counter terrorist financing requirements. This definition is without prejudice to each Party's right to identify additional competent authorities that can access information about beneficial owners. 2. Each Party shall ensure that legal entities in its territory maintain adequate, accurate and up-to-date information about beneficial owners. Each Party shall put in place mechanisms to ensure that their competent authorities have timely access to such information. 3. Each Party shall establish or maintain a central register holding adequate, up-to-date and accurate information about beneficial owners. In the case of the Union, the central registers shall be set up at the level of the Member States. This obligation shall not apply in respect of legal entities listed on a stock exchange that are subject to disclosure requirements regarding an adequate level of transparency. Where no beneficial owner is identified in respect of an entity, the register shall hold alternative information, such as a statement that no beneficial owner has been identified or details of the natural person or persons who hold the position of senior managing official in the legal entity. 4. Each Party shall ensure that the information held in its central register or registers is made available to its competent authorities without restriction and in a timely manner. 5. Each Party shall ensure that basic information about beneficial owners is made available to any member of the public. Limited exceptions may be made to the public availability of information under this paragraph in cases where public access would expose the beneficial owner to disproportionate risks, such as risks of fraud, kidnapping, blackmail, extortion, harassment, violence or intimidation, or where the beneficial owner is a minor or otherwise legally incapable. 6. Each Party shall ensure that there are effective, proportionate and dissuasive sanctions against legal or natural persons who fail to comply with requirements imposed on them in connection with the matters referred to in this Article. 7. Each Party shall ensure that its competent authorities are able to provide the information referred to in paragraphs 2 and 3 to the competent authorities of the other Party in a timely and effective manner and free of charge. To that end, the Parties shall consider ways to ensure the secure exchange of information. Article 655 Beneficial ownership transparency of legal arrangements 1. For the purposes of this Article, the following definitions apply: (a) "beneficial owner" means the settlor, the protector (if any), trustees, the beneficiary or class of beneficiaries, any person holding an equivalent position in relation to a legal arrangement with a structure or function similar to an express trust, and any other natural person exercising ultimate effective control over a trust or a similar legal arrangement; (b) "competent authorities" means: (i) public authorities, including Financial Intelligence Units, that have designated responsibilities for combating money laundering or terrorist financing; (ii) public authorities that have the function of investigating or prosecuting money laundering, associated predicate offences or terrorist financing or the function of tracing, seizing or freezing and confiscating criminal assets; (iii) public authorities that have supervisory or monitoring responsibilities aimed at ensuring compliance with anti-money laundering or counter terrorist financing requirements. This definition is without prejudice to each Party's right to identify additional competent authorities that can access information about beneficial owners. 2. Each Party shall ensure that trustees of express trusts maintain adequate, accurate and up-to-date information about beneficial owners. These measures shall also apply to other legal arrangements identified by each Party as having a structure or function similar to trusts. 3. Each Party shall put in place mechanisms to ensure that its competent authorities have timely access to adequate, accurate and up-to-date information about beneficial owners of express trusts and other legal arrangements with a structure or function similar to trusts in its territory. 4. If the beneficial ownership information about trusts or similar legal arrangements is held in a central register, the State concerned shall ensure that the information is adequate, accurate and up-to-date, and that competent authorities have timely and unrestricted access to such information. The Parties shall endeavour to consider ways to provide access to beneficial ownership information about trusts and similar legal arrangements to individuals or organisations who can demonstrate a legitimate interest in seeing such information. 5. Each Party shall ensure that there are effective, proportionate and dissuasive sanctions against legal or natural persons who fail to comply with requirements imposed on them in connection with the matters referred to in this Article. 6. Each Party shall ensure that its competent authorities are able to provide the information referred to in paragraph 3 to the competent authorities of the other Party in a timely and effective manner and free of charge. To that end, the Parties shall consider ways to ensure the secure exchange of information. TITLE XI FREEZING AND CONFISCATION Article 656 Objective and principles of cooperation 1. The objective of this Title is to provide for cooperation between the United Kingdom, on the one side, and the Member States, on the other side, to the widest extent possible for the purposes of investigations and proceedings aimed at the freezing of property with a view to subsequent confiscation thereof and investigations and proceedings aimed at the confiscation of property within the framework of proceedings in criminal matters. This does not preclude other cooperation pursuant to Article 665(5) and (6). This Title also provides for cooperation with Union bodies designated by the Union for the purposes of this Title. 2. Each State shall comply, under the conditions provided for in this Title, with requests from another State: (a) for the confiscation of specific items of property, as well as for the confiscation of proceeds consisting in a requirement to pay a sum of money corresponding to the value of proceeds; (b) for investigative assistance and provisional measures with a view to either form of confiscation referred to in point (a). 3. Investigative assistance and provisional measures sought under point (b) of paragraph 2 shall be carried out as permitted by and in accordance with the domestic law of the requested State. Where the request concerning one of these measures specifies formalities or procedures which are necessary under the domestic law of the requesting State, even if unfamiliar to the requested State, the latter shall comply with such requests to the extent that the action sought is not contrary to the fundamental principles of its domestic law. 4. The requested State shall ensure that the requests coming from another State to identify, trace, freeze or seize the proceeds and instrumentalities, receive the same priority as those made in the framework of domestic procedures. 5. When requesting confiscation, investigative assistance and provisional measures for the purposes of confiscation, the requesting State shall ensure that the principles of necessity and proportionality are respected. 6. The provisions of this Title apply in place of the "international cooperation" Chapters of the Council of Europe Convention on Laundering, Search, Seizure and Confiscation of the Proceeds from Crime and on the Financing of Terrorism, done at Warsaw on 16 May 2005 (the "2005 Convention") and the Convention on Laundering, Search, Seizure and Confiscation of the Proceeds from Crime, done at Strasbourg on 8 November 1990 (the "1990 Convention"). Article 657 of this Agreement replaces the corresponding definitions in Article 1 of the 2005 Convention and Article 1 of the 1990 Convention. The provisions of this Title do not affect the States' obligations under the other provisions of the 2005 Convention and the 1990 Convention. Article 657 Definitions For the purposes of this Title, the following definitions apply: (a) "confiscation" means a penalty or a measure ordered by a court following proceedings in relation to a criminal offence or criminal offences, resulting in the final deprivation of property; (b) "freezing" or "seizure" means temporarily prohibiting the transfer, destruction, conversion, disposition or movement of property or temporarily assuming custody or control of property on the basis of an order issued by a court or other competent authority; (c) "instrumentalities" means any property used or intended to be used, in any manner, wholly or in part, to commit a criminal offence or criminal offences; (d) "judicial authority" means an authority that is, under domestic law, a judge, a court or a public prosecutor; a public prosecutor is considered a judicial authority only to the extent that domestic law so provides; (e) "proceeds" means any economic benefit, derived from or obtained, directly or indirectly, from criminal offences, or an amount of money equivalent to that economic benefit; it may consist of any property as defined in this Article; (f) "property" includes property of any description, whether corporeal or incorporeal, movable or immovable, and legal documents or instruments evidencing title or interest in such property, which the requesting State considers to be: (i) the proceeds of a criminal offence, or its equivalent, whether the full amount of the value of such proceeds or only part of the value of such proceeds; (ii) the instrumentalities of a criminal offence, or the value of such instrumentalities; (iii) subject to confiscation under any other provisions relating to powers of confiscation under the law of the requesting State, following proceedings in relation to a criminal offence, including third party confiscation, extended confiscation and confiscation without final conviction. Article 658 Obligation to assist The States shall afford each other, upon request, the widest possible measure of assistance in the identification and tracing of instrumentalities, proceeds and other property liable to confiscation. Such assistance shall include any measure providing and securing evidence as to the existence, location or movement, nature, legal status or value of those instrumentalities, proceeds or other property. Article 659 Requests for information on bank accounts and safe deposit boxes 1. The requested State shall, under the conditions set out in this Article, take the measures necessary to determine, in answer to a request sent by another State, whether a natural or legal person that is the subject of a criminal investigation holds or controls one or more accounts, of whatever nature, in any bank located in its territory and, if so, provide the details of the identified accounts. These details shall in particular include the name of the customer account holder and the IBAN number, and, in the case of safe deposit boxes, the name of the lessee or a unique identification number. 2. The obligation set out in paragraph 1 applies only to the extent that the information is in the possession of the bank keeping the account. 3. In addition to the requirements of Article 680, the requesting State shall, in the request: (a) indicate why it considers that the requested information is likely to be of substantial value for the purposes of the criminal investigation into the offence; (b) state on what grounds it presumes that banks in the requested State hold the account and specify, to the widest extent possible, which banks and accounts may be involved; and (c) include any additional information available which may facilitate the execution of the request. 4. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that this Article will be extended to accounts held in non-bank financial institutions. Such notifications may be made subject to the principle of reciprocity. Article 660 Requests for information on banking transactions 1. On request by another State, the requested State shall provide the particulars of specified bank accounts and of banking operations which have been carried out during a specified period through one or more accounts specified in the request, including the particulars of any sending or recipient account. 2. The obligation set out in paragraph 1 applies only to the extent that the information is in the possession of the bank keeping the account. 3. In addition to the requirements of Article 680, the requesting State shall indicate in its request why it considers the requested information relevant for the purposes of the criminal investigation into the offence. 4. The requested State may make the execution of such a request dependent on the same conditions as it applies in respect of requests for search and seizure. 5. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that this Article will be extended to accounts held in non-bank financial institutions. Such notifications may be made subject to the principle of reciprocity. Article 661 Requests for the monitoring of banking transactions 1. The requested State shall ensure that, at the request of another State, it is able to monitor, during a specified period, the banking operations that are being carried out through one or more accounts specified in the request and to communicate the results of the monitoring to the requesting State. 2. In addition to the requirements of Article 680, the requesting State shall indicate in its request why it considers the requested information relevant for the purposes of the criminal investigation into the offence. 3. The decision to monitor shall be taken in each individual case by the competent authorities of the requested State, in accordance with its domestic law. 4. The practical details regarding the monitoring shall be agreed between the competent authorities of the requesting and requested States. 5. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that this Article will be extended to accounts held in non-bank financial institutions. Such notifications may be made subject to the principle of reciprocity. Article 662 Spontaneous information Without prejudice to its own investigations or proceedings, a State may without prior request forward to another State information on instrumentalities, proceeds and other property liable to confiscation, where it considers that the disclosure of such information might assist the receiving State in initiating or carrying out investigations or proceedings or might lead to a request by that State under this Title. Article 663 Obligation to take provisional measures 1. At the request of another State which has instituted a criminal investigation or proceedings, or an investigation or proceedings for the purposes of confiscation, the requested State shall take the necessary provisional measures, such as freezing or seizing, to prevent any dealing in, transfer or disposal of property which, at a later stage, may be the subject of a request for confiscation or which might satisfy the request. 2. A State which has received a request for confiscation pursuant to Article 665 shall, if so requested, take the measures referred to in paragraph 1 of this Article in respect of any property which is the subject of the request or which might satisfy the request. 3. Where a request is received under this Article, the requested State shall take all necessary measures to comply with the request without delay and with the same speed and priority as for a similar domestic case and send confirmation without delay and by any means of producing a written record to the requesting State. 4. Where the requesting State states that immediate freezing is necessary since there are legitimate grounds to believe that the property in question will immediately be removed or destroyed, the requested State shall take all necessary measures to comply with the request within 96 hours of receiving the request and send confirmation to the requesting State by any means of producing a written record and without delay. 5. Where the requested State is unable to comply with the time limits under paragraph 4, the requested State shall immediately inform the requesting State, and consult with the requesting State on the appropriate next steps. 6. Any expiration of the time limits under paragraph 4 does not extinguish the requirements placed on the requested State by this Article. Article 664 Execution of provisional measures 1. After the execution of the provisional measures requested in conformity with Article 663(1), the requesting State shall provide spontaneously and as soon as possible to the requested State all information which may question or modify the extent of those measures. The requesting State shall also provide without delay all complementary information required by the requested State and which is necessary for the implementation of and the follow-up to the provisional measures. 2. Before lifting any provisional measure taken pursuant to Article 663, the requested State shall, wherever possible, give the requesting State an opportunity to present its reasons in favour of continuing the measure. Article 665 Obligation to confiscate 1. The State which has received a request for confiscation of property situated in its territory shall: (a) enforce a confiscation order made by a court of the requesting State in relation to such property; or (b) submit the request to its competent authorities for the purpose of obtaining an order of confiscation and, if such an order is granted, enforce it. 2. For the purposes of point (b) of paragraph 1, the States shall, whenever necessary, have competence to institute confiscation proceedings under their own domestic law. 3. Paragraph 1 also applies to confiscation consisting in a requirement to pay a sum of money corresponding to the value of proceeds, if property against which the confiscation can be enforced is located in the requested State. In such cases, when enforcing confiscation pursuant to paragraph 1, the requested State shall, if payment is not obtained, realise the claim on any property available for that purpose. 4. If a request for confiscation concerns a specific item of property, the requesting State and requested State may agree that the requested State may enforce the confiscation in the form of a requirement to pay a sum of money corresponding to the value of the property. 5. A State shall cooperate to the widest extent possible under its domestic law with a State requesting the execution of measures equivalent to confiscation of property, where the request has not been issued in the framework of proceedings in criminal matters, in so far as such measures are ordered by a judicial authority of the requesting State in relation to a criminal offence, provided that it has been established that the property constitutes proceeds or: (a) other property into which the proceeds have been transformed or converted; (b) property acquired from legitimate sources, if proceeds have been intermingled, in whole or in part, with such property, up to the assessed value of the intermingled proceeds; or (c) income or other benefit derived from the proceeds, from property into which proceeds of crime have been transformed or converted or from property with which the proceeds of crime have been intermingled, up to the assessed value of the intermingled proceeds, in the same manner and to the same extent as proceeds. 6. The measures referred to in paragraph 5 include measures which allow the seizure, detention and forfeiture of property and assets by means of applications to civil courts. 7. The requested State shall take the decision on the execution of the confiscation order without delay, and, without prejudice to paragraph 8 of this Article, no later than 45 days after receiving the request. The requested State shall send confirmation to the requesting State by any means of producing a written record and without delay. Unless grounds for postponement under Article 672 exist, the requested State shall take the concrete measures necessary to execute the confiscation order without delay and, at least, with the same speed and priority as for a similar domestic case. 8. Where the requested State is unable to comply with the time limit under paragraph 7, the requested State shall immediately inform the requesting State, and consult with the requesting State on the appropriate next steps. 9. Any expiration of the time limit under paragraph 7 does not extinguish the requirements placed on the requested State by this Article. Article 666 Execution of confiscation 1. The procedures for obtaining and enforcing the confiscation under Article 665 shall be governed by the domestic law of the requested State. 2. The requested State shall be bound by the findings as to the facts in so far as they are stated in a conviction or judicial decision issued by a court of the requesting State or in so far as such conviction or judicial decision is implicitly based on them. 3. If the confiscation consists in the requirement to pay a sum of money, the competent authority of the requested State shall convert the amount thereof into the currency of that State at the rate of exchange applicable at the time when the decision to enforce the confiscation is taken. Article 667 Confiscated property 1. Subject to paragraphs 2 and 3 of this Article, property confiscated pursuant to Articles 665 and 666 shall be disposed of by the requested State in accordance with its domestic law and administrative procedures. 2. When acting on the request made by another State pursuant to Article 665, the requested State shall, to the extent permitted by its domestic law and if so requested, give priority consideration to returning the confiscated property to the requesting State so that it can give compensation to the victims of the crime or return such property to their legitimate owners. 3. Where acting on the request made by another State in accordance with Article 665, and after having taken into account the right of a victim to restitution or compensation of property pursuant to paragraph 2 of this Article, the requested State shall dispose of the money obtained as a result of the execution of a confiscation order as follows: (a) if the amount is equal to or less than EUR 10 000, the amount shall accrue to the requested State; or (b) if the amount is greater than EUR 10 000, the requested State shall transfer 50 % of the amount recovered to the requesting State. 4. Notwithstanding paragraph 3, the requesting State and requested State may, on a case-by-case basis, give special consideration to concluding other such agreements or arrangements on disposal of property as they deem appropriate. Article 668 Right of enforcement and maximum amount of confiscation 1. A request for confiscation made under Article 665 does not affect the right of the requesting State to enforce the confiscation order itself. 2. Nothing in this Title shall be interpreted as permitting the total value of the confiscation to exceed the amount of the sum of money specified in the confiscation order. If a State finds that this might occur, the States concerned shall enter into consultations to avoid such an effect. Article 669 Imprisonment in default The requested State shall not impose imprisonment in default or any other measure restricting the liberty of a person as a result of a request under Article 665 without the consent of the requesting State. Article 670 Grounds for refusal 1. Cooperation under this Title may be refused if: (a) the requested State considers that executing the request would be contrary to the principle of ne bis in idem; or (b) the offence to which the request relates does not constitute an offence under the domestic law of the requested State if committed within its jurisdiction; however, this ground for refusal applies to cooperation under Articles 658 to 662 only in so far as the assistance sought involves coercive action. 2. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that, on the basis of reciprocity, the condition of double criminality referred to in point (b) of paragraph 1 of this Article will not be applied provided that the offence giving rise to the request is: (a) one of the offences listed in Article 599(5), as defined by the law of the requesting State; and (b) punishable by the requesting State by a custodial sentence or a detention order for a maximum period of at least three years. 3. Cooperation under Articles 658 to 662, in so far as the assistance sought involves coercive action, and under Articles 663 and 664 may also be refused if the measures sought could not be taken under the domestic law of the requested State for the purposes of investigations or proceedings in a similar domestic case. 4. Where the domestic law of the requested State so requires, cooperation under Articles 658 to 662, in so far as the assistance sought involves coercive action, and under Articles 663 and 664 may also be refused if the measures sought or any other measures having similar effects would not be permitted under the domestic law of the requesting State, or, as regards the competent authorities of the requesting State, if the request is not authorised by a judicial authority acting in relation to criminal offences. 5. Cooperation under Articles 665 to 669 may also be refused if: (a) under the domestic law of the requested State, confiscation is not provided for in respect of the type of offence to which the request relates; (b) without prejudice to the obligation pursuant to Article 665(3), it would be contrary to the principles of the domestic law of the requested State concerning the limits of confiscation in respect of the relationship between an offence and: (i) an economic advantage that might be qualified as its proceeds; or (ii) property that might be qualified as its instrumentalities; (c) under the domestic law of the requested State, confiscation may no longer be imposed or enforced because of the lapse of time; (d) without prejudice to Article 665(5) and (6), the request does not relate to a previous conviction, or a decision of a judicial nature or a statement in such a decision that an offence or several offences have been committed, on the basis of which the confiscation has been ordered or is sought; (e) confiscation is either not enforceable in the requesting State, or it is still subject to ordinary means of appeal; or (f) the request relates to a confiscation order resulting from a decision rendered in absentia of the person against whom the order was issued and, in the opinion of the requested State, the proceedings conducted by the requesting State leading to such decision did not satisfy the minimum rights of defence recognised as due to everyone against whom a criminal charge is made. 6. For the purposes of point (f) of paragraph 5 a decision is not considered to have been rendered in absentia if: (a) it has been confirmed or pronounced after opposition by the person concerned; or (b) it has been rendered on appeal, provided that the appeal was lodged by the person concerned. 7. When considering, for the purposes of point (f) of paragraph 5, whether the minimum rights of defence have been satisfied, the requested State shall take into account the fact that the person concerned has deliberately sought to evade justice or the fact that that person, having had the possibility of lodging a legal remedy against the decision made in absentia, elected not to do so. The same applies where the person concerned, having been duly served with the summons to appear, elected not to do so nor to ask for adjournment. 8. The States shall not invoke bank secrecy as a ground to refuse any cooperation under this Title. Where its domestic law so requires, a requested State may require that a request for cooperation which would involve the lifting of bank secrecy be authorised by a judicial authority acting in relation to criminal offences. 9. The requested State shall not invoke the fact that: (a) the person under investigation or subject to a confiscation order by the authorities of the requesting State is a legal person as an obstacle to affording any cooperation under this Title; (b) the natural person against whom an order of confiscation of proceeds has been issued has died or a legal person against whom an order of confiscation of proceeds has been issued has subsequently been dissolved as an obstacle to affording assistance in accordance with point (a) of Article 665(1); or (c) the person under investigation or subject to a confiscation order by the authorities of the requesting State is mentioned in the request both as the author of the underlying criminal offence and of the offence of money laundering as an obstacle to affording any cooperation under this Title. Article 671 Consultation and information Where there are substantial grounds for believing that the execution of a freezing or confiscation order would entail a real risk for the protection of fundamental rights, the requested State shall, before it decides on the execution of the freezing or confiscation order, consult the requesting State and may require any necessary information to be provided. Article 672 Postponement The requested State may postpone action on a request if such action would prejudice investigations or proceedings by its authorities. Article 673 Partial or conditional granting of a request Before refusing or postponing cooperation under this Title, the requested State shall, where appropriate after having consulted the requesting State, consider whether the request may be granted partially or subject to such conditions as it deems necessary. Article 674 Notification of documents 1. The States shall afford each other the widest measure of mutual assistance in the serving of judicial documents to persons affected by provisional measures and confiscation. 2. Nothing in this Article is intended to interfere with: (a) the possibility of sending judicial documents, by postal channels, directly to persons abroad; and (b) the possibility for judicial officers, officials or other competent authorities of the State of origin to effect service of judicial documents directly through the consular authorities of that State or through the judicial authorities, including judicial officers and officials, or other competent authorities of the State of destination. 3. When serving judicial documents to persons abroad affected by provisional measures or confiscation orders issued in the sending State, that State shall indicate what legal remedies are available under its domestic law to such persons. Article 675 Recognition of foreign decisions 1. When dealing with a request for cooperation under Articles 663 to 669 the requested State shall recognise any decision issued by a judicial authority taken in the requesting State regarding rights claimed by third parties. 2. Recognition may be refused if: (a) third parties did not have adequate opportunity to assert their rights; (b) the decision is incompatible with a decision already taken in the requested State on the same matter; (c) it is incompatible with the ordre public of the requested State; or (d) the decision was taken contrary to provisions on exclusive jurisdiction provided for by the domestic law of the requested State. Article 676 Authorities 1. Each State shall designate a central authority to be responsible for sending and answering requests made under this Title, the execution of such requests or their transmission to the authorities competent for their execution. 2. The Union may designate a Union body which may, in addition to the competent authorities of the Member States, make and, if appropriate, execute requests under this Title. Any such request is to be treated for the purposes of this Title as a request by a Member State. The Union may also designate that Union body as the central authority responsible for the purpose of sending and answering requests made under this Title by, or to, that body. Article 677 Direct communication 1. The central authorities shall communicate directly with one another. 2. In urgent cases, requests or communications under this Title may be sent directly by the judicial authorities of the requesting State to judicial authorities of the requested State. In such cases, a copy shall be sent at the same time to the central authority of the requested State through the central authority of the requesting State. 3. Where a request is made pursuant to paragraph 2 and the authority is not competent to deal with the request, it shall refer the request to the competent national authority and shall directly inform the requesting State that it has done so. 4. Requests or communications under Articles 658 to 662, which do not involve coercive action, may be directly transmitted by the competent authorities of the requesting State to the competent authorities of the requested State. 5. Draft requests or communications under this Title may be sent directly by the judicial authorities of the requesting State to the judicial authorities of the requested State prior to a formal request to ensure that the formal request can be dealt with efficiently upon receipt and that it contains sufficient information and supporting documentation for it to meet the requirements of the law of the requested State. Article 678 Form of request and languages 1. All requests under this Title shall be made in writing. They may be transmitted electronically, or by any other means of telecommunication, provided that the requesting State is prepared, upon request, to produce a written record of such communication and the original at any time. 2. Requests under paragraph 1 shall be made in one of the official languages of the requested State or in any other language notified by or on behalf of the requested State in accordance with paragraph 3. 3. The United Kingdom and the Union, acting on behalf of any of its Member States, may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation of the language or languages which, in addition to the official language or languages of that State, may be used for making requests under this Title. 4. Requests under Article 663 for provisional measures shall be made using the prescribed form at Annex 46. 5. Requests under Article 665 for confiscation shall be made using the prescribed form at Annex 46. 6. The Specialised Committee on Law Enforcement and Judicial Cooperation may amend the forms referred to in paragraphs 4 and 5 as may be necessary. 7. The United Kingdom and the Union, acting on behalf of any of its Member States may each notify the Specialised Committee on Law Enforcement and Judicial Cooperation that it requires the translation of any supporting documents into one of the official languages of the requested State or any other language indicated in accordance with paragraph 3 of this Article. In the case of requests pursuant to Article 663(4), such translation of supporting documents may be provided to the requested State within 48 hours after transmitting the request, without prejudice to the time limits provided for in Article 663(4). Article 679 Legalisation Documents transmitted in application of this Title shall be exempt from all legalisation formalities. Article 680 Content of request 1. Any request for cooperation under this Title shall specify: (a) the authority making the request and the authority carrying out the investigations or proceedings; (b) the object of and the reason for the request; (c) the matters, including the relevant facts (such as date, place and circumstances of the offence) to which the investigations or proceedings relate, except in the case of a request for notification; (d) insofar as the cooperation involves coercive action: (i) the text of the statutory provisions or, where that is not possible, a statement of the relevant applicable law; and (ii) an indication that the measure sought or any other measures having similar effects could be taken in the territory of the requesting State under its own domestic law; (e) where necessary and in so far as possible: (i) details of the person or persons concerned, including name, date and place of birth, nationality and location, and, in the case of a legal person, its seat; and (ii) the property in relation to which cooperation is sought, its location, its connection with the person or persons concerned, any connection with the offence, as well as any available information about other persons, interests in the property; and (f) any particular procedure the requesting State wishes to be followed. 2. A request for provisional measures under Article 663 in relation to seizure of property on which a confiscation order consisting of the requirement to pay a sum of money may be realised shall also indicate a maximum amount for which recovery is sought in that property. 3. In addition to the information referred to in paragraph 1 of this Article, any request under Article 665 shall contain: (a) in the case of point (a) of Article 665(1): (i) a certified true copy of the confiscation order made by the court in the requesting State and a statement of the grounds on the basis of which the order was made, if they are not indicated in the order itself; (ii) an attestation by the competent authority of the requesting State that the confiscation order is enforceable and not subject to ordinary means of appeal; (iii) information as to the extent to which the enforcement of the order is requested; and (iv) information as to the necessity of taking any provisional measures; (b) in the case of point (b) of Article 665(1), a statement of the facts relied upon by the requesting State sufficient to enable the requested State to seek the order under its domestic law; (c) where third parties have had the opportunity to claim rights, documents demonstrating that this has been the case. Article 681 Defective requests 1. If a request does not comply with the provisions of this Title or the information supplied is not sufficient to enable the requested State to deal with the request, that State may ask the requesting State to amend the request or to complete it with additional information. 2. The requested State may set a time limit for the receipt of such amendments or information. 3. Pending receipt of the requested amendments or information in relation to a request under Article 665, the requested State may take any of the measures referred to in Articles 658 to 664. Article 682 Plurality of requests 1. Where the requested State receives more than one request under Article 663 or Article 665 in respect of the same person or property, the plurality of requests shall not prevent that State from dealing with the requests involving the taking of provisional measures. 2. In the case of a plurality of requests under Article 665, the requested State shall consider consulting the requesting States. Article 683 Obligation to give reasons The requested State shall give reasons for any decision to refuse, postpone or make conditional any cooperation under this Title. Article 684 Information 1. The requested State shall promptly inform the requesting State of: (a) the action initiated on the basis of a request under this Title; (b) the final result of the action carried out on the basis of a request under this Title; (c) a decision to refuse, postpone or make conditional, in whole or in part, any cooperation under this Title; (d) any circumstances which render impossible the carrying out of the action sought or are likely to delay it significantly; and (e) in the event of provisional measures taken pursuant to a request under Articles 658 to Article 663, such provisions of its domestic law as would automatically lead to the lifting of the provisional measure. 2. The requesting State shall promptly inform the requested State of: (a) any review, decision or any other fact by reason of which the confiscation order ceases to be wholly or partially enforceable; and (b) any development, factual or legal, by reason of which any action under this Title is no longer justified. 3. Where a State, on the basis of the same confiscation order, requests confiscation in more than one State, it shall inform all States which are affected by the enforcement of the order about the request. Article 685 Restriction of use 1. The requested State may make the execution of a request dependent on the condition that the information or evidence obtained is not, without its prior consent, to be used or transmitted by the authorities of the requesting State for investigations or proceedings other than those specified in the request. 2. Without the prior consent of the requested State, information or evidence provided by it under this Title shall not be used or transmitted by the authorities of the requesting State in investigations or proceedings other than those specified in the request. 3. Personal data communicated under this Title may be used by the State to which they have been transferred: (a) for the purposes of proceedings to which this Title applies; (b) for other judicial and administrative proceedings directly related to proceedings referred to in point (a); (c) for preventing an immediate and serious threat to public security; or (d) for any other purpose, only with the prior consent of the communicating State, unless the State concerned has obtained the consent of the data subject. 4. This Article shall also apply to personal data not communicated but obtained otherwise under this Title. 5. This Article does not apply to personal data obtained by the United Kingdom or a Member State under this Title and originating from that State. Article 686 Confidentiality 1. The requesting State may require that the requested State keep confidential the facts and substance of the request, except to the extent necessary to execute the request. If the requested State cannot comply with the requirement of confidentiality, it shall promptly inform the requesting State. 2. The requesting State shall, if not contrary to basic principles of its domestic law and if so requested, keep confidential any evidence and information provided by the requested State, except to the extent that its disclosure is necessary for the investigations or proceedings described in the request. 3. Subject to the provisions of its domestic law, a State which has received spontaneous information under Article 662 shall comply with any requirement of confidentiality as required by the State which supplies the information. If the receiving State cannot comply with such a requirement, it shall promptly inform the transmitting State. Article 687 Costs The ordinary costs of complying with a request shall be borne by the requested State. Where costs of a substantial or extraordinary nature are necessary to comply with a request, the requesting and requested States shall consult in order to agree the conditions on which the request is to be executed and how the costs will be borne. Article 688 Damages 1. Where legal action on liability for damages resulting from an act or omission in relation to cooperation under this Title has been initiated by a person, the States concerned shall consider consulting each other, where appropriate, to determine how to apportion any sum of damages due. 2. A State which has become the subject of litigation for damages shall endeavour to inform the other State of such litigation if that State might have an interest in the case. Article 689 Legal remedies 1. Each State shall ensure that persons affected by measures under Articles 663 to 666 have effective legal remedies in order to preserve their rights. 2. The substantive reasons for requested measures under Articles 663 to 666 shall not be challenged before a court in the requested State. TITLE XII OTHER PROVISIONS Article 690 Notifications 1. By the date of entry into force of this Agreement, the Union and the United Kingdom shall make any of the notifications provided for in Article 602(2), Article 603(2), and Article 611(4) and shall, to the extent it is possible to do so, indicate whether no such notification is to be made. To the extent that such a notification or indication has not been made in relation to a State, at the point in time referred to in the first subparagraph, notifications may be made in relation to that State as soon as possible and at the latest two months after the entry into force of this Agreement. During that interim period, any State in relation to which no notification provided for in Article 602(2), Article 603(2), or Article 611(4) has been made, and which has not been the subject of an indication that no such notification is to be made, may avail itself of the possibilities provided for in that Article as if such a notification had been made in respect of that State. In the case of Article 603(2), a State may only avail itself of the possibilities provided for in that Article to the extent that to do so is compatible with the criteria for making a notification. 2. The notifications referred to in Article 599(4), Article 605(1), Article 606(2), Article 625(1), Article 626(1), Article 659(4), Article 660(5), Article 661(5), Article 670(2), and Article 678(3) and (7) may be made at any time. 3. The notifications referred to in Article 605(1), Article 606(2) and Article 678(3) and (7) may be modified at any time. 4. The notifications referred to in Article 602(2), Article 603(2), Article 605(1), Article 611(4), Article 659(4), Article 660(5), and Article 661(5) may be withdrawn at any time. 5. The Union shall publish information on notifications of the United Kingdom referred to in Article 605(1) in the Official Journal of the European Union. 6. By the date of entry into force of this Agreement, the United Kingdom shall notify the Union of the identity of the following authorities: (a) the authority responsible for receiving and processing PNR data under Title III; (b) the authority considered as the competent law enforcement authority for the purposes of Title V and a short description of its competences; (c) the national contact point designated under Article 568(1); (d) the authority considered as the competent authority for the purposes of Title VI and a short description of its competences; (e) the contact point designated under Article 584(1); (f) the United Kingdom Domestic Correspondent for Terrorism Matters designated under Article 584(2); (g) the authority competent by virtue of domestic law of the United Kingdom to execute an arrest warrant, as referred to in point (c) of Article 598, and the authority competent by virtue of the domestic law of the United Kingdom to issue an arrest warrant, as referred to in point (d) of Article 598; (h) the authority designated by the United Kingdom under Article 623(3); (i) the central authority designated by the United Kingdom under Article 645; (j) the central authority designated by the United Kingdom under Article 676(1). The Union shall publish information about the authorities referred to in the first subparagraph in the Official Journal of the European Union. 7. By the date of entry into force of this Agreement, the Union shall, on its behalf or on behalf of its Member States as the case may be, notify the United Kingdom, of the identity of the following authorities: (a) the Passenger Information Units established or designated by each Member State for the purposes of receiving and processing PNR data under Title III; (b) the authority competent by virtue of the domestic law of each Member State to execute an arrest warrant, as referred to in point (c) of Article 598, and the authority competent by virtue of the domestic law of each Member State to issue an arrest warrant, as referred to in point (d) of Article 598; (c) the authority designated for each Member State under Article 623(3); (d) the Union body referred to in Article 634; (e) the central authority designated by each Member State under Article 645; (f) the central authority designated by each Member State under Article 676(1); (g) any Union body designated under the first sentence of Article 676(2) and whether it is also designated as a central authority under the last sentence of that paragraph. 8. The notifications made under paragraph 6 or 7 may be modified at any time. Such modifications shall be notified to the Specialised Committee on Law Enforcement and Judicial Cooperation. 9. The United Kingdom and the Union may notify more than one authority with respect to points (a), (b), (d), (e), (g), (h), (i) and (j) of paragraph 6 and with respect to paragraph 7 respectively and may limit such notifications for particular purposes only. 10. Where the Union makes the notifications referred to in this Article, it shall indicate to which of its Member States the notification applies or whether it is making the notification on its own behalf. Article 691 Review and evaluation 1. This Part shall be jointly reviewed in accordance with Article 776 or at the request of either Party where jointly agreed. 2. The Parties shall decide in advance on how the review is to be conducted and shall communicate to each other the composition of their respective review teams. The review teams shall include persons with appropriate expertise with respect to the issues under review. Subject to applicable laws, all participants in a review shall be required to respect the confidentiality of the discussions and to have appropriate security clearances. For the purposes of such reviews, the United Kingdom and the Union shall make arrangements for appropriate access to relevant documentation, systems and personnel. 3. Without prejudice to paragraph 2, the review shall in particular address the practical implementation, interpretation and development of this Part. Article 692 Termination 1. Without prejudice to Article 779, each Party may at any moment terminate this Part by written notification through diplomatic channels. In that event, this Part shall cease to be in force on the first day of the ninth month following the date of notification. 2. However, if this Part is terminated on account of the United Kingdom or a Member State having denounced the European Convention on Human Rights or Protocols 1, 6 or 13 thereto, this Part shall cease to be in force as of the date that such denunciation becomes effective or, if the notification of its termination is made after that date, on the fifteenth day following such notification. 3. If either Party gives notice of termination under this Article, the Specialised Committee on Law Enforcement and Judicial Cooperation shall meet to decide what measures are needed to ensure that any cooperation initiated under this Part is concluded in an appropriate manner. In any event, with regard to all personal data obtained through cooperation under this Part before it ceases to be in force, the Parties shall ensure that the level of protection under which the personal data were transferred is maintained after the termination takes effect. Article 693 Suspension 1. In the event of serious and systemic deficiencies within one Party as regards the protection of fundamental rights or the principle of the rule of law, the other Party may suspend this Part or Titles thereof, by written notification through diplomatic channels. Such notification shall specify the serious and systemic deficiencies on which the suspension is based. 2. In the event of serious and systemic deficiencies within one Party as regards the protection of personal data, including where those deficiencies have led to a relevant adequacy decision ceasing to apply, the other Party may suspend this Part or Titles thereof, by written notification through diplomatic channels. Such notification shall specify the serious and systemic deficiencies on which the suspension is based. 3. For the purposes of paragraph 2, "relevant adequacy decision" means: (a) in relation to the United Kingdom, a decision adopted by the European Commission, in accordance with Article 36 of Directive (EU) 2016/680 of the European Parliament and of the Council (82) or analogous successor legislation, attesting to the adequate level of protection; (b) in relation to the Union, a decision adopted by the United Kingdom attesting to the adequate level of protection for the purposes of transfers falling within the scope of Part 3 of the Data Protection Act 2018 (83) or analogous successor legislation. 4. In relation to the suspension of Title III or Title X, references to a "relevant adequacy decision" also include: (a) in relation to the United Kingdom, a decision adopted by the European Commission, in accordance with Article 45 of Regulation (EU) 2016/679 of the European Parliament and of the Council (84) (General Data Protection Regulation) or analogous successor legislation attesting to the adequate level of protection; (b) in relation to the Union, a decision adopted by the United Kingdom attesting to the adequate level of protection for the purposes of transfers falling within the scope of Part 2 of the Data Protection Act 2018 or analogous successor legislation. 5. The Titles concerned by the suspension shall provisionally cease to apply on the first day of the third month following the date of the notification referred to in paragraph 1 or 2, unless, no later than two weeks before the expiry of that period, as extended, as the case may be, in accordance with point (d) of paragraph 7, the Party which notified the suspension gives written notification to the other Party, through diplomatic channels, of its withdrawal of the first notification or of a reduction in scope of the suspension. In the latter case, only the Titles referred to in the second notification shall provisionally cease to apply. 6. If one Party notifies the suspension of one or several Titles of this Part pursuant to paragraph 1 or 2, the other Party may suspend all of the remaining Titles, by written notification through diplomatic channels, with three months' notice. 7. Upon the notification of a suspension pursuant to paragraph 1 or 2, the Partnership Council shall immediately be seized of the matter. The Partnership Council shall explore possible ways of allowing the Party that notified the suspension to postpone its entry into effect, to reduce its scope or to withdraw it. To that end, upon a recommendation of the Specialised Committee on Law Enforcement and Judicial Cooperation, the Partnership Council may: (a) agree on joint interpretations of provisions of this Part; (b) recommend any appropriate action to the Parties; (c) adopt appropriate adaptations to this Part which are necessary to address the reasons underlying the suspension, with a maximum validity of 12 months; and (d) extend the period referred to in paragraph 5 by up to three months. 8. If either Party gives notification of suspension under this Article, the Specialised Committee on Law Enforcement and Judicial Cooperation shall meet to decide what measures are needed to ensure that any cooperation initiated under this Part and affected by the notification is concluded in an appropriate manner. In any event, with regard to all personal data obtained through cooperation under this Part before the Titles concerned by the suspension provisionally cease to apply, the Parties shall ensure that the level of protection under which the personal data were transferred is maintained after the suspension takes effect. 9. The suspended Titles shall be reinstated on the first day of the month following the day on which the Party having notified the suspension pursuant to paragraph 1 or 2 has given written notification to the other Party, through diplomatic channels, of its intention to reinstate the suspended Titles. The Party having notified the suspension pursuant to paragraph 1 or 2 shall do so immediately after the serious and systemic deficiencies on the part of the other Party on which the suspension was based have ceased to exist. 10. Upon the notification of the intention to reinstate the suspended Titles in accordance with paragraph 9, the remaining Titles suspended pursuant to paragraph 6 shall be reinstated at the same time as the Titles suspended pursuant to paragraph 1 or 2. Article 694 Expenses The Parties and the Member States, including institutions, bodies, offices and agencies of the Parties or the Member States, shall bear their own expenses which arise in the course of implementation of this Part, unless otherwise provided for in this Agreement. TITLE XIII DISPUTE SETTLEMENT Article 695 Objective The objective of this Title is to establish a swift, effective and efficient mechanism for avoiding and settling disputes between the Parties concerning this Part, including disputes concerning this Part when applied to situations governed by other provisions of this Agreement, with a view to reaching a mutually agreed solution, where possible. Article 696 Scope 1. This Title applies to disputes between the Parties concerning this Part (the "covered provisions"). 2. The covered provisions shall include all provisions of this Part, with the exception of Articles 526 and 541, Article 552(14), Articles 562, 692, 693 and 700. Article 697 Exclusivity The Parties undertake not to submit a dispute between them regarding this Part to a mechanism of settlement other than that provided for in this Title. Article 698 Consultations 1. If a Party (the "complaining Party") considers that the other Party (the "responding Party") has breached an obligation under this Part, the Parties shall endeavour to resolve the matter by entering into consultations in good faith, with the aim of reaching a mutually agreed solution. 2. The complaining Party may seek consultations by means of a written request delivered to the responding Party. The complaining Party shall specify in its written request the reasons for the request, including identification of the acts or omissions that the complaining Party considers as giving rise to the breach of an obligation by the responding Party, specifying the covered provisions it considers applicable. 3. The responding Party shall reply to the request promptly, and no later than two weeks after the date of its delivery. Consultations shall be held regularly within a period of three months following the date of delivery of the request in person or by any other means of communication agreed by the Parties. 4. The consultations shall be concluded within three months of the date of delivery of the request, unless the Parties agree to continue the consultations. 5. The complaining Party may request that the consultations be held in the framework of the Specialised Committee on Law Enforcement and Judicial Cooperation or in the framework of the Partnership Council. The first meeting shall take place within one month of the request for consultations referred to in paragraph 2 of this Article. The Specialised Committee on Law Enforcement and Judicial Cooperation may at any time decide to refer the matter to the Partnership Council. The Partnership Council may also seize itself of the matter. The Specialised Committee on Law Enforcement and Judicial Cooperation, or as the case may be, the Partnership Council, may resolve the dispute by a decision. Such a decision shall be considered a mutually agreed solution within the meaning of Article 699. 6. The complaining Party may at any time unilaterally withdraw its request for consultations. In such a case, the consultations shall be terminated immediately. 7. Consultations, and in particular all information designated as confidential and positions taken by the Parties during consultations, shall be confidential. Article 699 Mutually agreed solution 1. The Parties may at any time reach a mutually agreed solution with respect to any dispute referred to in Article 696. 2. The mutually agreed solution may be adopted by means of a decision of the Specialised Committee on Law Enforcement and Judicial Cooperation or the Partnership Council. Where the mutually agreed solution consists of an agreement on joint interpretations of provisions of this Part by the Parties, that mutually agreed solution shall be adopted by means of a decision of the Partnership Council. 3. Each Party shall take the measures necessary to implement the mutually agreed solution within the agreed time period. 4. No later than the date of expiry of the agreed time period, the implementing Party shall inform the other Party in writing of any measures taken to implement the mutually agreed solution. Article 700 Suspension 1. Where consultations under Article 698 have not led to a mutually agreed solution within the meaning of Article 699, provided that the complaining Party has not withdrawn its request for consultations in accordance with Article 698(6), and where it considers that the respondent Party is in serious breach of its obligations under the covered provisions referred to in Article 698(2), the complaining Party may suspend the Titles of this Part to which the serious breach pertains, by written notification through diplomatic channels. Such notification shall specify the serious breach of obligations by the responding Party on which the suspension is based. 2. The Titles concerned by the suspension shall provisionally cease to apply on the first day of the third month following the date of the notification referred to in paragraph 1 or any other date mutually agreed by the Parties, unless, no later than two weeks before the expiry of that period, the complaining Party gives written notification to the responding Party, through diplomatic channels, of its withdrawal of the first notification or of a reduction in scope of the suspension. In the latter case, only the Titles referred to in the second notification shall provisionally cease to apply. 3. If the complaining Party notifies the suspension of one or several Titles of this Part pursuant to paragraph 1, the respondent Party may suspend all of the remaining Titles, by written notification through diplomatic channels, with three months' notice. 4. If a notification of suspension is given under this Article, the Specialised Committee on Law Enforcement and Judicial Cooperation shall meet to decide what measures are needed to ensure that any cooperation initiated under this Part and affected by the notification is concluded in an appropriate manner. In any event, with regard to all personal data obtained through cooperation under this Part before the Titles concerned by the suspension provisionally cease to apply, the Parties shall ensure that the level of protection under which the personal data were transferred is maintained after the suspension takes effect. 5. The suspended Titles shall be reinstated on the first day of the month following the date on which the complaining Party has given written notification to the respondent Party, through diplomatic channels, of its intention to reinstate the suspended Titles. The complaining Party shall do so immediately when it considers that the serious breach of the obligations on which the suspension was based has ceased to exist. 6. Upon notification by the complaining Party of its intention to reinstate the suspended Titles in accordance with paragraph 5, the remaining Titles suspended by the respondent Party pursuant to paragraph 3 shall be reinstated at the same time as the Titles suspended by the complaining Party pursuant to paragraph 1. Article 701 Time Periods 1. All time periods laid down in this Title shall be counted in weeks or months, as the case may be, from the day following the act to which they refer. 2. Any time period referred to in this Title may be modified by mutual agreement of the Parties. PART FOUR THEMATIC COOPERATION TITLE I HEALTH SECURITY Article 702 Cooperation on health security 1. For the purpose of this Article, a "serious cross-border threat to health" means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin which spreads or entails a significant risk of spreading across the borders of at least one Member State and the United Kingdom. 2. The Parties shall inform each other of a serious cross-border threat to health affecting the other Party and shall endeavour to do so in a timely manner. 3. Where there is a serious cross-border threat to health, following a written request from the United Kingdom, the Union may grant the United Kingdom ad hoc access to its Early Warning and Response System ("EWRS") in respect of the particular threat to enable the Parties and Member States' competent authorities to exchange relevant information, to assess public health risks, and to coordinate the measures that could be required to protect public health. The Union shall endeavour to respond to the United Kingdom's written request in a timely manner. Moreover, the Union may invite the United Kingdom to participate in a committee established within the Union and composed of representatives of Member States for the purposes of supporting the exchange of information and of coordination in relation to the serious cross-border threat to health. Both arrangements shall be on a temporary basis, and in any event for no longer than the duration that either of the Parties, having consulted the other Party, considers necessary for the relevant serious cross-border threat to health. 4. For the purposes of the information exchange referred to in paragraph 2 and any requests made pursuant to paragraph 3, each Party shall designate a focal point and notify the other Party thereof. The focal points shall also: (a) endeavour to facilitate understanding between the Parties as to whether or not a threat is a serious cross-border threat to health; (b) seek mutually agreed solutions to any technical issues arising from implementation of this Title. 5. The United Kingdom shall observe all applicable conditions for the use of the EWRS and the rules of procedure of the committee referred to in paragraph 3, for the period of access granted in respect of a particular serious cross-border threat to health. If, following clarificatory exchanges between the Parties: (a) the Union considers that the United Kingdom has not observed the above-mentioned conditions or rules of procedure, the Union may terminate the access of the United Kingdom to the EWRS or its participation in that committee, as the case may be, in respect of that threat; (b) the United Kingdom considers that it cannot accept the conditions or rules of procedure, the United Kingdom may withdraw its participation in the EWRS or its participation in that committee, as the case may be, in respect of that threat. 6. Where in their mutual interests the Parties shall cooperate in international forums on the prevention of, detection of, preparation for, and response to established and emerging threats to health security. 7. The European Centre for Disease Prevention and Control and the relevant body in the United Kingdom responsible for surveillance, epidemic intelligence and scientific advice on infectious diseases shall cooperate on technical and scientific matters of mutual interest to the Parties and, to that end, may conclude a memorandum of understanding. TITLE II CYBER SECURITY Article 703 Dialogue on cyber issues The Parties shall endeavour to establish a regular dialogue in order to exchange information about relevant policy developments, including in relation to international security, security of emerging technologies, internet governance, cybersecurity, cyber defence and cybercrime. Article 704 Cooperation on cyber issues 1. Where in their mutual interest, the Parties shall cooperate in the field of cyber issues by sharing best practices and through cooperative practical actions aimed at promoting and protecting an open, free, stable, peaceful and secure cyberspace based on the application of existing international law and norms for responsible State behaviour and regional cyber confidence-building measures. 2. The Parties shall also endeavour to cooperate in relevant international bodies and forums, and endeavour to strengthen global cyber resilience and enhance the ability of third countries to fight cybercrime effectively. Article 705 Cooperation with the Computer Emergency Response Team – European Union Subject to prior approval by the Steering Board of the Computer Emergency Response Team – European Union (CERT-EU), CERT-EU and the national UK computer emergency response team shall cooperate on a voluntary, timely and reciprocal basis to exchange information on tools and methods, such as techniques, tactics, procedures and best practices, and on general threats and vulnerabilities. Article 706 Participation in specific activities of the Cooperation Group established pursuant to Directive (EU) 2016/1148 1. With a view to promoting cooperation on cyber security while ensuring the autonomy of the Union decision-making process, the relevant national authorities of the United Kingdom may participate at the invitation, which the United Kingdom may also request, of the Chair of the Cooperation Group in consultation with the Commission, in the following activities of the Cooperation Group: (a) exchanging best practices in building capacity to ensure the security of network and information systems; (b) exchanging information with regard to exercises relating to the security of network and information systems; (c) exchanging information, experiences and best practices on risks and incidents; (d) exchanging information and best practices on awareness-raising, education programmes and training; and (e) exchanging information and best practices on research and development relating to the security of network and information systems. 2. Any exchange of information, experiences or best practices between the Cooperation Group and the relevant national authorities of the United Kingdom shall be voluntary and, where appropriate, reciprocal. Article 707 Cooperation with the European Union Agency for Cybersecurity (ENISA) 1. With a view to promoting cooperation on cyber security while ensuring the autonomy of the Union decision-making process, the United Kingdom may participate at the invitation, which the United Kingdom may also request, of the Management Board of the European Union Agency for Cybersecurity (ENISA), in the following activities carried out by ENISA: (a) capacity building; (b) knowledge and information; and (c) awareness raising and education. 2. The conditions for the participation of the United Kingdom in ENISA's activities referred to in paragraph 1, including an appropriate financial contribution, shall be set out in working arrangements adopted by the Management Board of ENISA subject to prior approval by the Commission and agreed with the United Kingdom. 3. The exchange of information, experiences and best practices between ENISA and the United Kingdom shall be voluntary and, where appropriate, reciprocal. PART FIVE PARTICIPATION IN UNION PROGRAMMES, SOUND FINANCIAL MANAGEMENT AND FINANCIAL PROVISIONS Article 708 Scope 1. This Part applies to the participation of the United Kingdom in Union programmes, activities and services thereunder, in which the Parties have agreed that the United Kingdom participates. 2. This Part shall not apply to the participation of the United Kingdom in cohesion programmes under the European territorial cooperation goal or similar programmes having the same objective, which takes place on the basis of the basic acts of one or more Union institutions applicable to those programmes. The applicable conditions for participation in the programmes referred to in the first subparagraph shall be specified in the applicable basic act and the financing agreement concluded thereunder. The Parties shall agree provisions with similar effect to Chapter 2 concerning the participation of the United Kingdom in those programmes. Article 709 Definitions For the purposes of this Part, the following definitions apply: (a) "basic act" means: (i) an act of one or more Union institutions establishing a programme or activity, which provides a legal basis for an action and for the implementation of the corresponding expenditure entered in the Union budget or of the budgetary guarantee backed by the Union budget, including any amendment and any relevant acts of a Union institution which supplement or implement that act, except those adopting work programmes, or (ii) an act of one or more Union institutions establishing an activity financed from the Union budget other than programmes; (b) "funding agreement" means agreements relating to Union programmes and activities under Protocol I on Programmes and activities in which the United Kingdom participates which implement Union funds, such as grant agreements, contribution agreements, financial framework partnership agreements, financing agreements and guarantee agreements; (c) "other rules pertaining to the implementation of the Union programme and activity" means rules laid down in the Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (85) ("Financial Regulation") that apply to the general budget of the Union, and in the work programme or in the calls or other Union award procedures; (d) "Union" means the Union or the European Atomic Energy Community, or both, as the context may require; (e) "Union award procedure" means a procedure for award of Union funding launched by the Union or by persons or entities entrusted with the implementation of Union funds; (f) "United Kingdom entity" means any type of entity, whether a natural person, legal person or another type of entity, which may participate in activities of a Union programme or activity in accordance with the basic act and who resides or which is established in the United Kingdom. CHAPTER 1 PARTICIPATION OF THE UNITED KINGDOM IN UNION PROGRAMMES AND ACTIVITIES SECTION 1 GENERAL CONDITIONS FOR PARTICIPATION IN UNION PROGRAMMES AND ACTIVITIES Article 710 Establishment of the participation 1. The United Kingdom shall participate in and contribute to the Union programmes, activities, or in exceptional cases, the part of Union programmes or activities, which are open to its participation, and which shall be listed in a Protocol on Programmes and activities in which the United Kingdom participates ("Protocol I"). 2. Protocol I shall be agreed between the Parties. It shall be adopted and may be amended by the Specialised Committee on Participation in Union Programmes. 3. Protocol I shall: (a) identify the Union programmes, activities, or in exceptional cases, the part of Union programmes or activities, in which the United Kingdom shall participate; (b) lay down the duration of participation, which shall refer to the period of time during which the United Kingdom and United Kingdom entities may apply for Union funding or may be entrusted with implementation of Union funds; (c) lay down specific conditions for the participation of the United Kingdom and United Kingdom entities, including specific modalities for the implementation of the financial conditions as identified under Article 714, specific modalities of the correction mechanism as identified under Article 716, and conditions for participation in structures created for the purposes of implementing those Union programmes or activities. These conditions shall comply with this Agreement and the basic acts and acts of one or more Union institutions establishing such structures; (d) where applicable, lay down the amount of United Kingdom's contribution to a Union programme implemented through a financial instrument or a budgetary guarantee and, where appropriate, specific modalities referred to in Article 717. Article 711 Compliance with programme rules 1. The United Kingdom shall participate in the Union programmes, activities or parts thereof listed in Protocol I under the terms and conditions established in this Agreement, in the basic acts and other rules pertaining to the implementation of Union programmes and activities. 2. The terms and conditions referred to in paragraph 1 shall include: (a) the eligibility of the United Kingdom entities and any other eligibility conditions related to the United Kingdom, in particular to the origin, place of activity or nationality; (b) the terms and conditions applicable to the submission, assessment and selection of applications and to the implementation of the actions by eligible United Kingdom entities. 3. The terms and conditions referred to in point (b) of paragraph 2 shall be equivalent to those applicable to eligible Member States entities, except in duly justified exceptional cases as provided for in the terms and conditions referred to in paragraph 1. Either party may bring to the attention of the Specialised Committee on Participation in Union Programmes the need for a discussion of duly justified exclusions. Article 712 Conditions for participation 1. The United Kingdom's participation in a Union programme or activity, or parts thereof as referred to in Article 708 shall be conditional upon the United Kingdom: (a) making every effort, within the framework of its domestic laws, to facilitate the entry and residence of persons involved in the implementation of these programmes and activities, or parts thereof, including students, researchers, trainees or volunteers; (b) ensuring, as far as it is under the control of the United Kingdom authorities, that the conditions for the persons referred to in point (a) to access services in the United Kingdom that are directly related to the implementation of the programmes or activities are the same as for United Kingdom nationals, including as regards any fees; (c) as regards participation involving exchange of or access to classified or sensitive non-classified information, having in place the appropriate agreements in accordance with Article 777. 2. In relation to the United Kingdom's participation in a Union programme or activity, or parts thereof as referred to in Article 708 the Union and its Member States shall: (a) make every effort, within the framework of Union or the Member States legislation, to facilitate the entry and residence of United Kingdom nationals involved in the implementation of these programmes and activities, or parts thereof, including students, researchers, trainees or volunteers; (b) ensure, as far as it is under the control of the Union and Member States' authorities, that the conditions for the United Kingdom nationals referred to in point (a) to access services in the Union that are directly related to the implementation of the programmes or activities are the same as for Union citizens, including as regards any fees. 3. Protocol I may lay down further specific conditions referring to this Article, which are necessary for the participation of the United Kingdom in a Union programme or activity, or parts thereof. 4. This Article is without prejudice to Article 711. 5. This Article and Article 718, are also without prejudice to any arrangements made between the United Kingdom and Ireland concerning the Common Travel Area. Article 713 Participation of the United Kingdom in the governance of programmes or activities 1. Representatives or experts of the United Kingdom, or experts designated by the United Kingdom shall be allowed to take part, as observers unless it concerns points reserved only for Member States or in relation to a programme or activity in which the United Kingdom is not participating, in the committees, expert groups meetings or other similar meetings where representatives or experts of the Member States, or experts designated by Member States take part, and which assist the European Commission in the implementation and management of the programmes, the activities or parts thereof, in which the United Kingdom participates in accordance with Article 708 or are established by the European Commission in respect of the implementation of the Union law in relation to these programmes, activities or parts thereof. The representatives or experts of the United Kingdom, or experts designated by the United Kingdom shall not be present at the time of voting. The United Kingdom shall be informed of the result of the vote. 2. Where experts or evaluators are not appointed on the basis of nationality, nationality shall not be a reason to exclude United Kingdom nationals. 3. Subject to the conditions of paragraph 1, participation of the United Kingdom's representatives in the meetings referred to in paragraph 1, or in other meetings related to the implementation of programmes or activities, shall be governed by the same rules and procedures as those applicable to representatives of the Member States, in particular speaking rights, receipt of information and documentation unless it concerns points reserved only for Member States or in relation to a programme or activity in which the United Kingdom is not participating, and the reimbursement of travel and subsistence costs. 4. Protocol I may define further modalities for the participation of experts, as well as the participation of the United Kingdom in governing boards and structures created for the purposes of implementing Union programmes or activities defined in that Protocol. SECTION 2 RULES FOR FINANCING THE PARTICIPATION IN UNION PROGRAMMES AND ACTIVITIES Article 714 Financial conditions 1. Participation of the United Kingdom or United Kingdom entities in Union programmes, activities or parts thereof shall be subject to the United Kingdom contributing financially to the corresponding funding under the Union budget. 2. The financial contribution shall take the form of the sum of: (a) a participation fee; and (b) an operational contribution. 3. The financial contribution shall take the form of an annual payment made in one or more instalments. 4. Without prejudice to Article 733, the participation fee shall be 4 % of the annual operational contribution and shall not be subject to retrospective adjustments except in relation to suspension under point (b) of Article 718(7) and termination under point (c) of Article 720(6). As of 2028 the level of the participation fee may be adjusted by the Specialised Committee on Participation in Union Programmes. 5. The operational contribution shall cover operational and support expenditure and be additional both in commitment and payment appropriations to the amounts entered in the Union budget definitively adopted for programmes or activities or exceptionally parts thereof increased, where appropriate, by external assigned revenue that does not result from financial contributions to Union programmes and activities from other donors, as defined in Protocol I. 6. The operational contribution shall be based on a contribution key defined as the ratio of the Gross Domestic Product (GDP) of the United Kingdom at market prices to the GDP of the Union at market prices. The GDPs at market prices to be applied shall be the latest available as of 1 January of the year in which the annual payment is made as provided by Statistical Office of the European Union (EUROSTAT), as soon as the arrangement referred to in Article 730 applies and according to the rules of this arrangement. Before this arrangement applies, the GDP of the United Kingdom shall be the one established on the basis of data provided by the Organisation for Economic Co-operation and Development (OECD). 7. The operational contribution shall be based on the application of the contribution key to the initial commitment appropriations increased as described in paragraph 5 entered in the Union budget definitively adopted for the applicable year for financing the Union programmes or activities or exceptionally parts thereof in which the United Kingdom participates. 8. The operational contribution of a programme, activity or part thereof for a year N may be adjusted upwards or downwards retrospectively in one or more subsequent years on the basis of the budgetary commitments made on the commitment appropriations of that year, their implementation through legal commitments and their decommitment. The first adjustment shall be made in year N+1 when the initial contribution shall be adjusted upwards or downwards by the difference between the initial contribution and an adjusted contribution calculated by applying the contribution key of year N to the sum of: (a) the amount of budgetary commitments made on commitment appropriations authorised in year N under the European Union adopted budget and on commitment appropriations corresponding to decommitments made available again; and (b) any external assigned revenue appropriations that do not result from financial contributions to Union programmes and activities from other donors as defined in Protocol I and that were available at the end of year N. Each subsequent year, until all the budgetary commitments financed under commitment appropriations originating from year N have been paid or decommitted and at the latest three years after the end of the programme or after the end of the multiannual financial framework corresponding to year N, whichever is earlier, the Union shall calculate an adjustment of the contribution of year N by reducing the United Kingdom contribution by the amount obtained by applying the contribution key of year N to the decommitments made each year on commitments of year N financed under the Union budget or from decommitments made available again. If external assigned revenue appropriations that do not result from financial contributions to Union programmes and activities from other donors as defined in Protocol I are cancelled, the contribution of the United Kingdom shall be reduced by the amount obtained by applying the contribution key of year N to the amount cancelled. In year N+2 or in subsequent years, after having made the adjustments referred to in the second, third and fourth subparagraphs, the contribution of the United Kingdom for year N shall also be reduced by an amount obtained by multiplying the contribution of the United Kingdom for year N and the ratio of: (a) the legal commitments of year N, funded under any commitment appropriations available in year N, and resulting from competitive award procedures, (i) from which the United Kingdom and the United Kingdom entities have been excluded; or (ii) for which the Specialised Committee on Participation in Union Programmes has decided, in accordance with the procedure established in Article 715 that there has been a quasi-exclusion of United Kingdom or United Kingdom entities; or (iii) for which the deadline for submission of applications has expired during the suspension referred to in Article 718 or after termination referred to in Article 720 has taken effect; or (iv) for which the participation of the United Kingdom and United Kingdom entities has been limited in accordance with Article 722(3); and (b) the total amount of legal commitments funded under any commitment appropriations of year N. This amount of legal commitments shall be calculated by taking all budgetary commitments made in year N and deducting the decommitments that have been made on these commitments in year N+1. 9. Upon request, the Union shall provide the United Kingdom with information in relation to its financial participation as included in the budgetary, accounting, performance and evaluation related information provided to the Union budgetary and discharge authorities concerning the Union programmes and activities in which the United Kingdom participates. That information shall be provided having due regard to the Union's and United Kingdom's confidentiality and data protection rules and is without prejudice to the information which the United Kingdom is entitled to receive under Chapter 2. 10. All contributions of the United Kingdom or payments from the Union, and the calculation of amounts due or to be received, shall be made in euros. 11. Subject to paragraph 5 and the second subparagraph of paragraph 8 of this Article, the detailed provisions for the implementation of this Article are set out in Annex 47. Annex 47 may be amended by the Specialised Committee on Participation in Union Programmes. Article 715 Quasi exclusion from competitive grant award procedure 1. When the United Kingdom considers that certain conditions laid down in a competitive grant award procedure amount to a quasi-exclusion of United Kingdom entities, the United Kingdom shall notify the Specialised Committee on Participation in Union Programmes before the deadline for submission of applications in the procedure concerned and shall provide justification. 2. Within three months of the deadline for submission of applications in the award procedure concerned, the Specialised Committee on Participation in Union Programmes shall examine the notification referred to in the paragraph 1 provided that the participation rate of United Kingdom entities in the award procedure concerned is at least 25 % lower compared to: (a) the average participation rate of United Kingdom entities in similar competitive award procedures not containing such a condition and launched within the three years preceding the notification; or, (b) in the absence of similar competitive award procedures, the average participation rate of United Kingdom entities in all competitive award procedures launched under the programme, or the preceding programme, as relevant, within the 3 years preceding the notification. 3. The Specialised Committee on Participation in Union Programmes shall by the end of the period referred to in paragraph 2, decide whether there has been a quasi-exclusion of the United Kingdom entities from the award procedure concerned in light of the justification provided by the United Kingdom pursuant to paragraph 1 and the effective participation rate in the award procedure concerned. 4. For the purposes of paragraphs 2 and 3, the participation rate shall be the ratio of the number of applications submitted by United Kingdom entities to the total number of applications submitted within the same award procedure. Article 716 Programmes to which an automatic correction mechanism applies 1. An automatic correction mechanism shall apply in relation to those Union programmes, activities or parts thereof for which the application of an automatic correction mechanism is provided in Protocol I. The application of that automatic correction mechanism may be limited to parts of the programme or activity specified in Protocol I, which are implemented through grants for which competitive calls are organised. Detailed rules on the identification of the parts of the programme or activity to which the automatic correction mechanism does or does not apply may be established in Protocol I. 2. The amount of the automatic correction for a programme or activity or parts thereof shall be the difference between the initial amounts of the legal commitments actually entered into with the United Kingdom or United Kingdom entities financed from commitment appropriations of the year in question and the corresponding operational contribution paid by the United Kingdom as adjusted pursuant to Article 714(8), excluding support expenditure, covering the same period if that amount is positive. 3. Any amount referred to in paragraph 2 of this Article, which for each of two consecutive years exceeds 8 % of the corresponding contribution of the United Kingdom to the programme as adjusted pursuant to Article 714(8) shall be due by the United Kingdom as an additional contribution under the automatic correction mechanism for each of those two years. 4. Detailed rules on the establishment of the relevant amounts of the legal commitments referred to in paragraph 2 of this Article, including in the case of consortia, and on the calculation of the automatic correction may be laid down in Protocol I. Article 717 Financing in relation to programmes implemented through financial instruments or budgetary guarantees 1. Where the United Kingdom participates in a Union programme, activity, or parts thereof that is implemented through a financial instrument or budgetary guarantee, the contribution of the United Kingdom to programmes implemented through financial instruments or budgetary guarantees under the Union budget implemented under Title X of the Financial Regulation applicable to the general budget of the Union shall be made in the form of cash. The amount contributed in cash shall increase the Union budgetary guarantee or the financial envelope of the financial instrument. 2. Where the United Kingdom participates in a programme referred to in paragraph 1 of this Article that is implemented by the European Investment Bank Group, if the European Investment Bank Group needs to cover losses that are not covered by the guarantee provided by the Union budget, the United Kingdom shall pay to the European Investment Bank Group a percentage of those losses equal to the ratio of the Gross Domestic Product at market prices of the United Kingdom to the sum of the Gross Domestic Product at market prices of the Member States, the United Kingdom and any other third country participating in that programme. The Gross Domestic Product at market prices to be applied shall be the latest available as of 1 January of the year in which the payment is due as provided by EUROSTAT, as soon as the arrangement referred to in Article 730 applies and according to the rules of this arrangement. Before this arrangement applies, the GDP of the United Kingdom shall be the one established on the basis of data provided by the OECD. 3. Where appropriate, modalities for the implementation of this Article, in particular ensuring that the United Kingdom receives its share of unused contributions to budgetary guarantees and financial instruments, shall be specified further in Protocol I. SECTION 3 SUSPENSION AND TERMINATION OF THE PARTICIPATION IN UNION PROGRAMMES Article 718 Suspension of the participation of the United Kingdom in a Union programme by the Union 1. The Union may unilaterally suspend the application of Protocol I, in relation to one or more Union programmes, activities, or exceptionally parts thereof in accordance with this Article, if the United Kingdom does not pay its financial contribution in accordance with Section 2 of this Chapter or if the United Kingdom introduces significant changes to one of the following conditions that existed when the United Kingdom participation in a programme, an activity or exceptionally part thereof was agreed and included in Protocol I, and if such changes have a significant impact on their implementation: (a) the conditions for entry and residence in the United Kingdom of the persons that are involved in the implementation of these programmes and activities, or parts thereof, including students, researchers, trainees or volunteers are changed. This shall apply, in particular, if the United Kingdom introduces a change in its domestic laws for the conditions for entry and residence in the United Kingdom for these persons, which discriminates between Member States; (b) there is a change in financial charges, including fees, that apply to persons referred in point (a) in order to perform the activities that they have to perform in order to implement the programme; (c) the conditions referred to in Article 712(3) are changed. 2. The Union shall notify the Specialised Committee on Participation in Union Programmes of its intention to suspend the participation of the United Kingdom in the programme or activity concerned. The Union shall identify the scope of the suspension and provide due justification. Unless the Union withdraws its notification, the suspension shall take effect 45 days following the date of notification by the Union. The date on which the suspension takes effect shall constitute the suspension reference date for the purposes of this Article. Prior to notification and suspension, and during the suspension period, the Specialised Committee on Participation in Union Programmes may discuss appropriate measures for avoiding or lifting the suspension. In case the Specialised Committee on Participation in Union Programmes finds an agreement for avoiding the suspension within the period referred to in the first subparagraph, the suspension shall not take effect. In any case, the Specialised Committee on Participation in Union Programmes shall meet during the period of 45 days to discuss the matter. 3. As of the suspension reference date the United Kingdom shall not be treated as a country participating in the Union programme, activity, or part thereof concerned by the suspension and in particular, the United Kingdom or United Kingdom entities shall no longer be eligible under the conditions laid down in Article 711 and Protocol I, with regard to Union award procedures which have not been completed yet on that date. An award procedure shall be considered completed when legal commitments have been entered into as a result of that procedure. 4. The suspension shall not affect legal commitments entered into before the suspension reference date. This Agreement shall continue to apply to such legal commitments. 5. The United Kingdom shall notify the Union as soon as it considers that compliance with the conditions for participation has been restored, and shall provide the Union with any relevant evidence to that effect. Within 30 days from that notification the Union shall assess the matter and may, for that purpose, request the United Kingdom to present additional evidence. The time needed to provide such additional evidence shall not be taken into account in the overall period for assessment. Where the Union has found that compliance with the conditions for participation is restored, it shall notify without undue delay the Specialised Committee on Participation in Union Programmes that the suspension is lifted. The lifting shall take effect on the day following the date of notification. Where the Union has found that compliance with the conditions for participation is not restored, the suspension shall remain in force. 6. The United Kingdom shall be treated again as a country participating in the Union programme or activity concerned, and in particular United Kingdom and United Kingdom entities shall be again eligible under the conditions laid down in Article 711 and Protocol I, with regard to Union award procedures under that Union programme or activity which were launched after the date on which the lifting of the suspension takes effect, or which were launched before that date, and for which the deadline for the submission of applications has not expired. 7. In case of the United Kingdom participation in a programme, activity, or part thereof being suspended, the financial contribution of the United Kingdom that is due during the period of suspension shall be established as follows: (a) the Union shall recalculate the operational contribution using the procedure described in point (a)(iii) of the fifth subparagraph of Article 714(8); (b) the participation fee shall be adjusted in line with the adjustment of the operational contribution. Article 719 Termination of the participation of the United Kingdom in a Union programme by the Union 1. If, by one year after the reference date referred to in Article 718(2) the Union has not lifted the suspension under Article 718, the Union shall either: (a) reassess the conditions under which it may offer to allow the United Kingdom to continue participating in the Union programmes, activities or parts thereof concerned and shall propose those conditions to the Specialised Committee on Participation in Union Programmes within 45 days from expiry of the one year suspension period with a view to modifying Protocol I. In the absence of an agreement on those measures by the Specialised Committee within a further period of 45 days, termination shall take effect as referred to in point (b) of this paragraph; or (b) terminate unilaterally the application of Protocol I, in relation to the Union programmes, activities or parts thereof concerned, in accordance with this Article, taking into account the impact of the change referred to in Article 718 on the implementation of the programme or activity or exceptionally parts thereof, or the amount of the unpaid contribution. 2. The Union shall notify the Specialised Committee on Participation in Union Programmes of its intention to terminate the participation of the United Kingdom in one or more Union programmes or activities pursuant to point (b) of paragraph 1. The Union shall identify the scope of the termination and provide due justification. Unless the Union withdraws its notification, the termination shall take effect 45 days following the date of notification by the Union. The date on which the termination takes effect shall constitute the termination reference date for the purposes of this Article. 3. As of the termination reference date the United Kingdom shall not be treated as a country participating in the Union programme or activity concerned by the termination, and in particular the United Kingdom or United Kingdom entities shall no longer be eligible under the conditions laid down in Article 711 and in Protocol I, with regard to Union award procedures which have not been completed yet as of that date. An award procedure shall be considered to have been completed if legal commitments have been entered into as a result of that procedure. 4. The termination shall not affect legal commitments entered into before the suspension reference date referred to in Article 718(2). This Agreement shall continue to apply to such legal commitments. 5. Where the application of Protocol I, or a part thereof, is terminated in respect of the programmes or activities or exceptionally parts thereof concerned: (a) the operational contribution covering support expenditure related to legal commitments already entered into shall continue to be due until the completion of those legal commitments or the end of the multiannual financial framework under which the legal commitment has been financed; (b) no contribution except the one referred to in point (a) shall be made in the following years. Article 720 Termination of the participation in a programme or activity in the case of substantial modification to Union programmes 1. The United Kingdom may unilaterally terminate its participation in a Union programme or activity or part thereof referred to in Protocol I where: (a) the basic act of that Union programme or activity is amended to an extent that the conditions for participation of the United Kingdom or of United Kingdom entities in that Union programme or activity have been substantially modified, in particular, as a result of a change of the objectives of the programme or activity and of the corresponding actions; or (b) the total amount of commitment appropriations as referred to in Article 714 is increased by more than 15 % compared with the initial financial envelope of that programme or activity or part thereof in which the United Kingdom participates and either the corresponding ceiling of the multiannual financial framework has been increased or the amount of external revenue referred to in Article 714(5) for the whole period of participation has been increased; or (c) the United Kingdom or United Kingdom entities are excluded from participation in part of a programme or activity on duly justified grounds, and that exclusion concerns commitment appropriations exceeding 10 % of the commitment appropriations in the Union budget definitively adopted for a year N for that programme or activity. 2. To this effect, the United Kingdom shall notify its intention to terminate Protocol I in relation to the Union programme or activity concerned, to the Specialised Committee on Participation in Union Programmes at the latest 60 days after the publication of the amendment or of the adopted annual budget or an amendment to it in the Official Journal of the European Union. The United Kingdom shall explain the reasons for which the United Kingdom considers the amendment to substantially alter the conditions of participation. The Specialised Committee on Participation in Union Programmes shall meet within 45 days of receiving the notification to discuss the matter. 3. Unless the United Kingdom withdraws its notification, the termination shall take effect 45 days following the date of notification by the United Kingdom. The date on which the termination takes effect shall constitute the reference date for the purposes of this Article. 4. As of the reference date the United Kingdom shall not be treated as a country participating in the Union programme or activity concerned by the termination, and in particular the United Kingdom or United Kingdom entities shall no longer be eligible under the conditions laid down in Article 711 and in Protocol I, with regard to Union award procedures which have not been completed yet as of that date. An award procedure shall be considered to have been completed if legal commitments have been entered into as a result of that procedure. 5. The termination shall not affect legal commitments entered into before the reference date. This Agreement shall continue to apply to such legal commitments. 6. In case of termination under this Article in respect of the programmes or activities concerned: (a) the operational contribution covering support expenditure related to legal commitments already entered into shall continue to be due until the completion of those legal commitments or the end of the multiannual financial framework under which the legal commitment has been financed; (b) the Union shall recalculate the operational contribution of the year where termination occurs using the procedure described in point (a)(iii) of the fifth subparagraph of Article 714(8). No contribution except the one referred to in point (a) of this Article shall be made in the following years; (c) the participation fee shall be adjusted in line with the adjustment of the operational contribution. SECTION 4 REVIEW OF PERFORMANCE AND FINANCIAL INCREASES Article 721 Performance review 1. A performance review procedure shall apply in accordance with the conditions laid down in this Article in relation to parts of the Union programme or activity to which the correction mechanism referred to in Article 716 applies. 2. The United Kingdom may request the Specialised Committee on Participation in Union Programmes to start the performance review procedure where the amount calculated in accordance with the method laid down in Article 716(2) is negative, and where that amount is higher than 12 % of the corresponding contributions of the United Kingdom to the programme or activity as adjusted pursuant to Article 714(8). 3. The Specialised Committee on Participation in Union Programmes, within a period of three months from the date of the request referred to in paragraph 2, shall analyse the relevant performance-related data and adopt a report proposing appropriate measures to address performance related issues. The measures referred to in the first subparagraph shall be applied for a period of twelve months after the adoption of the report. Following the application of the measures, performance data over the period in question shall be used to calculate the difference between the initial amounts due under the legal commitments actually entered into with the United Kingdom or United Kingdom entities during that calendar year and the corresponding operational contribution paid by the United Kingdom for the same year. If the difference referred to in the second subparagraph is negative and exceeds 16 % of the corresponding operational contribution, the United Kingdom may: (a) notify its intention to terminate its participation in the Union programme or part of a programme concerned by giving notice 45 days before the intended day of termination, and may terminate its participation in accordance with Article 720(3) to (6); or (b) request the Specialised Committee on Participation in Union Programmes to adopt further measures to address underperformance, including by making adaptations to the participation of the United Kingdom in the Union programme concerned and adjusting future financial contributions of the United Kingdom in respect of that programme. Article 722 Financial increases review 1. The United Kingdom may notify the Specialised Committee on Participation in Union Programmes that it objects to the amount of its contribution to a Union programme or activity if the total amount of commitment appropriations as referred to in Article 714 is increased by more than 5 % compared with the initial financial envelope for that Union programme or activity and either the corresponding ceiling has been increased or the amount of external revenue referred to in Article 714(5) for the whole period of participation has been increased. 2. The notification referred to in paragraph 1 of this Article shall be made within 60 days as of the publication date of the adopted annual budget or an amendment to it in the Official Journal of the European Union. The notification shall be without prejudice to the obligation of the United Kingdom to pay its contribution and to the application of the adjustment mechanism referred to in Article 714(8). 3. The Specialised Committee on Participation in Union Programmes shall prepare a report, propose and decide on the adoption of appropriate measures within three months from the date of the notification referred to in paragraph 2 of this Article. Those measures may include limiting the participation of the United Kingdom and United Kingdom entities to certain types of actions or award procedures or, where appropriate, a modification of Protocol I. The limitation of the United Kingdom's participation will be treated as an exclusion for the purposes of the adjustment mechanism referred to in Article 714(8). 4. Where the conditions referred to in point (b) of Article 720(1) are fulfilled, the United Kingdom may terminate its participation in a Union programme or activity referred to in Protocol I in accordance with Article 720(2) to (6). CHAPTER 2 SOUND FINANCIAL MANAGEMENT Article 723 Scope This Chapter shall apply in relation to the Union programmes, activities and services under Union programmes referred to in Protocol I and Protocol II on access of the United Kingdom to services established under certain Union programmes and activities in which the United Kingdom does not participate (Protocol II). SECTION 1 PROTECTION OF FINANCIAL INTERESTS AND RECOVERY Article 724 Conduct of activity for the purposes of sound financial management For the purposes of the application of this Chapter, the authorities of the United Kingdom and of the Union referred to in this Chapter shall cooperate closely in accordance with their respective laws and regulations. When exercising their duties in the territory of the United Kingdom, the agents and investigative bodies of the Union shall act in a manner consistent with United Kingdom law. Article 725 Reviews and audits 1. The Union shall have the right to conduct as provided in relevant funding agreements or contracts and in accordance with the applicable acts of one or more Union institutions, technical, scientific, financial, or other types of reviews and audits on the premises of any natural person residing in or legal entity established in the United Kingdom and receiving Union funding, as well as any third party involved in the implementation of Union funding residing or established in the United Kingdom. Such reviews and audits may be carried out by the agents of the institutions and bodies of the Union, in particular of the European Commission and the European Court of Auditors, or by other persons mandated by the European Commission in accordance with Union law. 2. The agents of the institutions and bodies of the Union, in particular the agents of the European Commission and the European Court of Auditors, as well as other persons mandated by the European Commission, shall have appropriate access to sites, works and documents (in electronic versions, paper versions, or both) and to all the information required in order to carry out such reviews and audits, as referred to in paragraph 1. Such access shall include the right to obtain physical or electronic copies of, and extracts from, any document or the contents of any data medium held by audited natural or legal persons, or by the audited third party. 3. The United Kingdom shall not prevent or raise any obstacle to the right of the agents and other persons referred to in paragraph 2 to enter the United Kingdom and to access the premises of the audited persons, in the exercise of their duties referred to in this Article. 4. Notwithstanding the suspension or termination of the United Kingdom's participation in a programme or activity, the suspension of part or all of the provisions of this Part and/or Protocol I or the termination of this Agreement, the reviews and audits may be carried out also after the date on which the relevant suspension or termination takes effect, on the terms laid down in the applicable acts of one or more Union institutions and as provided in the relevant funding agreements or contracts in relation to any legal commitment implementing the Union budget entered into by the Union before the date on which the relevant suspension or termination takes effect. Article 726 Fight against irregularities, fraud and other criminal offences affecting the financial interests of the Union 1. The European Commission and the European Anti-Fraud Office (OLAF) shall be authorised to carry out administrative investigations, including on-the-spot checks and inspections, in the territory of the United Kingdom. The European Commission and OLAF shall act in accordance with the Union acts governing those checks, inspections and investigations. 2. The competent United Kingdom authorities shall inform the European Commission or OLAF within a reasonable period of any fact or suspicion which has come to their notice relating to an irregularity, fraud or other illegal activity affecting the financial interests of the Union. 3. On-the-spot checks and inspections may be carried out on the premises of any natural person residing in or legal entity established in the United Kingdom and that receives Union funding under a funding agreement or a contract, as well as on the premises of any third party involved in the implementation of such Union funding residing or established in the United Kingdom. Such checks and inspections shall be prepared and conducted by the European Commission or OLAF in close collaboration with the competent United Kingdom authority designated by the United Kingdom. The designated authority shall be notified within a reasonable period before the checks and inspections of the object, purpose and legal basis of those checks and inspections, to enable it to provide assistance. To that end, the officials of the competent United Kingdom authorities may participate in the on-the-spot checks and inspections. 4. The agents of the European Commission and OLAF shall have access to all the information and documentation (in electronic versions, paper versions, or both) relating to the operations referred to in paragraph 3, which are required for the proper conduct of the on-the-spot checks and inspections. In particular, the agents of the European Commission and OLAF may copy relevant documents. 5. The European Commission or OLAF and the competent United Kingdom authorities shall decide on a case-by-case basis whether to conduct on-the-spot checks and inspections jointly, including where both parties are competent to conduct investigations. 6. Where the person, entity or another third party who is subject to an on-the-spot check or inspection resists an on-the-spot check or inspection, the United Kingdom authorities, acting in accordance with national rules and regulations, shall assist the European Commission or OLAF, to enable them to fulfil their duties in carrying out the on-the-spot check or inspection. Such assistance shall include taking the appropriate precautionary measures under national law, including measures to safeguard evidence. 7. The European Commission or OLAF shall inform the competent United Kingdom authorities of the result of such checks and inspections. In particular the European Commission or OLAF shall report as soon as possible to the competent United Kingdom authority any fact or suspicion relating to an irregularity which has come to their notice in the course of the on-the-spot check or inspection. 8. Without prejudice to application of United Kingdom law, the European Commission may impose administrative measures and penalties on legal or natural persons participating in the implementation of a programme or activity in accordance with Union legislation. 9. For the purposes of the proper implementation of this Article, the European Commission or OLAF and the United Kingdom competent authorities shall regularly exchange information and, at the request of one of the parties to this Agreement, consult each other, unless prohibited under Union legislation or under United Kingdom law. 10. In order to facilitate effective cooperation and the exchange of information with OLAF the United Kingdom shall designate a contact point. 11. The exchange of information between the European Commission or OLAF and the United Kingdom competent authorities shall comply with applicable confidentiality requirements. Personal data included in the exchange of information shall be protected in accordance with applicable rules. 12. Without prejudice to the applicability of Article 634, where any United Kingdom national, or natural persons residing in the United Kingdom, or legal entities established in the United Kingdom receive Union funding under Union programmes and activities listed in Protocol I, directly or indirectly, including in connection with any third party involved in the implementation of such Union funding, the United Kingdom authorities shall cooperate with the Union authorities or authorities of the Member States of the Union responsible for investigating, prosecuting and bringing to judgement the perpetrators of, and accomplices to, criminal offences affecting the financial interests of the Union in relation to such funding, in accordance with the applicable legislation and international instruments, to allow them to fulfil their duties. Article 727 Amendments to Articles 708, 723, 725 and 726 The Specialised Committee on Participation in Union Programmes may amend Articles 725 and 726, in particular to take account of changes of acts of one or more Union institutions. The Specialised Committee on Participation in Union Programmes may amend Article 708 and Article 723 to extend the application of this Chapter to other Union programmes, activities and services. Article 728 Recovery and enforcement 1. Decisions adopted by the European Commission imposing a pecuniary obligation on legal or natural persons other than States in relation to any claims stemming from Union programmes, activities, actions or projects shall be enforceable in the United Kingdom. The order for its enforcement shall be appended to the decision, without any other formality than a verification of the authenticity of the decision by the national authority designated for this purpose by the United Kingdom. The United Kingdom shall make known its designated national authority to the Commission and the Court of Justice of the European Union. In accordance with Article 729, the European Commission shall be entitled to notify such enforceable decisions directly to persons residing and legal entities established in the United Kingdom. The enforcement of those decisions shall take place in accordance with United Kingdom law. 2. Judgments and orders of the Court of Justice of the European Union delivered in application of an arbitration clause contained in a contract or agreement in relation to Union programmes, activities or parts thereof under Protocol I shall be enforceable in the United Kingdom in the same manner as European Commission decisions, as referred to in paragraph 1 of this Article. 3. The Court of Justice of the European Union shall have jurisdiction to review the legality of the decisions of the Commission referred to in paragraph 1 and to suspend the enforcement of such decisions. However, the Courts of the United Kingdom shall have jurisdiction over complaints alleging that enforcement is being carried out in an irregular manner. SECTION 2 OTHER RULES FOR THE IMPLEMENTATION OF UNION PROGRAMMES Article 729 Communication and exchange of information The Union institutions and bodies involved in the implementation of Union programmes or activities, or in control of such programmes or activities, shall be entitled to communicate directly, including through electronic exchange systems, with any natural person residing in the United Kingdom or legal entity established in the United Kingdom receiving Union funding, as well as with any third party involved in the implementation of Union funding that resides or is established in the United Kingdom. Such persons, entities and third parties may submit directly to the Union institutions and bodies all relevant information and documentation which they are required to submit on the basis of the Union legislation applicable to the Union programme or activity or on the basis of the contracts or funding agreements concluded to implement that programme or activity. Article 730 Statistical cooperation EUROSTAT and the United Kingdom Statistics Authority may establish an arrangement that enables cooperation on relevant statistical matters and includes that EUROSTAT, with the agreement of the United Kingdom Statistics Authority, provides statistical data on the United Kingdom for the purposes of this Part, including, in particular, data on the GDP of the United Kingdom. CHAPTER 3 ACCESS OF THE UNITED KINGDOM TO SERVICES UNDER UNION PROGRAMMES Article 731 Rules on service access 1. Where the United Kingdom does not participate in a Union programme or activity in accordance with Chapter 1, it may nevertheless have access to services provided under Union programmes and activities under the terms and conditions established in this Agreement, the basic acts and any other rules pertaining to the implementation of Union programmes and activities. 2. Protocol II shall, where appropriate: (a) identify the services under Union programmes and activities, to which the United Kingdom and United Kingdom entities shall have access; (b) lay down specific conditions for the access by the United Kingdom and United Kingdom entities. Those conditions shall comply with the conditions laid down in this Agreement and in the basic acts; (c) where applicable, specify the United Kingdom's financial or in-kind contribution with respect to a service provided under such Union programmes and activities. 3. Protocol II shall be adopted and may be amended by the Specialised Committee on Participation in Union Programmes. 4. The United Kingdom and public and private spacecraft owners and operators operating in or from the United Kingdom shall have access to the services provided under Article 5(1) of Decision No 541/2014/EU of the European Parliament and of the Council (86) in accordance with Article 5(2) of that Decision until provisions on similar access are included in Protocol II or until 31 December 2021. CHAPTER 4 REVIEWS Article 732 Review clause Four years after Protocols I and II become applicable, the Specialised Committee on Participation in Union Programmes shall review the implementation thereof on the basis of the data concerning the participation of United Kingdom entities in indirect and direct actions under the programme, parts of the programme, activities and services covered under Protocols I and II. Following a request by either Party, the Specialised Committee on Participation in Union Programmes shall discuss changes or proposed changes affecting the terms of the United Kingdom participation in any of the programmes or parts of programmes, activities and services listed in Protocols I and II, and, if necessary, may propose appropriate measures within the scope of this Agreement. CHAPTER 5 PARTICIPATION FEE IN THE YEARS 2021 TO 2026 Article 733 Participation fee in the years 2021 to 2026 The participation fee referred to in Article 714(4) shall have the following value in the years 2021 to 2026: — in 2021: 0,5 %; — in 2022: 1 %; — in 2023: 1,5 %; — in 2024: 2 %; — in 2025: 2,5 %; — in 2026: 3 %. PART SIX DISPUTE SETTLEMENT AND HORIZONTAL PROVISIONS TITLE I DISPUTE SETTLEMENT CHAPTER 1 GENERAL PROVISIONS Article 734 Objective The objective of this Title is to establish an effective and efficient mechanism for avoiding and settling disputes between the Parties concerning the interpretation and application of this Agreement and supplementing agreements with a view to reaching, where possible, a mutually agreed solution. Article 735 Scope 1. This Title applies, subject to paragraphs 2, 3, 4 and 5, to disputes between the Parties concerning the interpretation and application of the provisions of this Agreement or of any supplementing agreement ("covered provisions"). 2. The covered provisions shall include all provisions of this Agreement and of any supplementing agreement with the exception of: (a) Article 32(1) to (6) and Article 36; (b) Annex 12; (c) Title VII of Heading one of Part Two; (d) Title X of Heading One of Part Two; (e) Article 355(1), (2) and (4), Article 356(1) and (3), Chapter 2 of Title XI of Heading One of Part Two, Articles 371 and 372, Chapter 5 of Title XI of Heading One of Part Two, and Article 411(4) to (9); (f) Part Three, including when applying in relation to situations governed by other provisions of this Agreement; (g) Part Four; (h) Title II of Part Six; (i) Article 782; and (j) the Agreement on security procedures for exchanging and protecting classified information. 3. The Partnership Council may be seized by a Party with a view to resolving a dispute with respect to obligations arising from the provisions referred to in paragraph 2. 4. Article 736 applies to the provisions referred to in paragraph 2 of this Article. 5. Notwithstanding paragraphs 1 and 2, this Title shall not apply with respect to disputes concerning the interpretation and application of the provisions of the Protocol on Social Security Coordination or its annexes in individual cases. Article 736 Exclusivity The Parties undertake not to submit a dispute between them regarding the interpretation or application of provisions of this Agreement or of any supplementing agreement to a mechanism of settlement other than those provided for in this Agreement. Article 737 Choice of forum in case of a substantially equivalent obligation under another international agreement 1. If a dispute arises regarding a measure allegedly in breach of an obligation under this Agreement or any supplementing agreement and of a substantially equivalent obligation under another international agreement to which both Parties are party, including the WTO Agreement, the Party seeking redress shall select the forum in which to settle the dispute. 2. Once a Party has selected the forum and initiated dispute settlement procedures either under this Title or under another international agreement, that Party shall not initiate such procedures under the other international agreement with respect to the particular measure referred to in paragraph 1, unless the forum selected first fails to make findings for procedural or jurisdictional reasons. 3. For the purposes of this Article: (a) dispute settlement procedures under this Title are deemed to be initiated by a Party's request for the establishment of an arbitration tribunal under Article 739; (b) dispute settlement procedures under the WTO Agreement are deemed to be initiated by a Party's request for the establishment of a panel under Article 6 of the Understanding on Rules and Procedure Governing the Settlement of Disputes of the WTO; and (c) dispute settlement procedures under any other agreement are deemed to be initiated if they are initiated in accordance with the relevant provisions of that agreement. 4. Without prejudice to paragraph 2, nothing in this Agreement or any supplementing agreement shall preclude a Party from suspending obligations authorised by the Dispute Settlement Body of the WTO or authorised under the dispute settlement procedures of another international agreement to which the Parties are party. The WTO Agreement or any other international agreement between the Parties shall not be invoked to preclude a Party from suspending obligations under this Title. CHAPTER 2 PROCEDURE Article 738 Consultations 1. If a Party (the "complaining Party") considers that the other Party (the "respondent Party") has breached an obligation under this Agreement or under any supplementing agreement, the Parties shall endeavour to resolve the matter by entering into consultations in good faith, with the aim of reaching a mutually agreed solution. 2. The complaining Party may seek consultations by means of a written request delivered to the respondent Party. The complaining Party shall specify in its written request the reasons for the request, including the identification of the measures at issue and the legal basis for the request, and the covered provisions it considers applicable. 3. The respondent Party shall reply to the request promptly, and in any case no later than 10 days after the date of its delivery. Consultations shall be held within 30 days of the date of delivery of the request in person or by any other means of communication agreed by the Parties. If held in person, consultations shall take place in the territory of the respondent Party, unless the Parties agree otherwise. 4. The consultations shall be deemed concluded within 30 days of the date of delivery of the request, unless the Parties agree to continue consultations. 5. Consultations on matters of urgency, including those regarding perishable goods or seasonal goods or services, shall be held within 20 days of the date of delivery of the request. The consultations shall be deemed concluded within those 20 days unless the Parties agree to continue consultations. 6. Each Party shall provide sufficient factual information to allow a complete examination of the measure at issue, including an examination of how that measure could affect the application of this Agreement or any supplementing agreement. Each Party shall endeavour to ensure the participation of personnel of their competent authorities who have expertise in the matter subject to the consultations. 7. For any dispute concerning an area other than Titles I to VII, Chapter 4 of Title VIII, Titles IX to XII of Heading One or Heading Six of Part Two, at the request of the complaining Party, the consultations referred to in paragraph 3 of this Article shall be held in the framework of a Specialised Committee or of the Partnership Council. The Specialised Committee may at any time decide to refer the matter to the Partnership Council. The Partnership Council may also seize itself of the matter. The Specialised Committee, or, as the case may be, the Partnership Council, may resolve the dispute by a decision. The time periods referred to in paragraph 3 of this Article shall apply. The venue of meetings shall be governed by the rules of procedure of the Specialised Committee or, as the case may be, the Partnership Council. 8. Consultations, and in particular all information designated as confidential and positions taken by the Parties during consultations, shall be confidential, and shall be without prejudice to the rights of either Party in any further proceedings. Article 739 Arbitration procedure 1. The complaining Party may request the establishment of an arbitration tribunal if: (a) the respondent Party does not respond to the request for consultations within 10 days of the date of its delivery; (b) consultations are not held within the time periods referred to in Article 738(3), (4) or (5); (c) the Parties agree not to have consultations; or (d) consultations have been concluded without a mutually agreed solution having been reached. 2. The request for the establishment of the arbitration tribunal shall be made by means of a written request delivered to the respondent Party. In its request, the complaining Party shall explicitly identify the measure at issue and explain how that measure constitutes a breach of the covered provisions in a manner sufficient to present the legal basis for the complaint clearly. Article 740 Establishment of an arbitration tribunal 1. An arbitration tribunal shall be composed of three arbitrators. 2. No later than 10 days after the date of delivery of the request for the establishment of an arbitration tribunal, the Parties shall consult with a view to agreeing on the composition of the arbitration tribunal. 3. If the Parties do not agree on the composition of the arbitration tribunal within the time period provided for in paragraph 2 of this Article, each Party shall appoint an arbitrator from the sub-list for that Party established pursuant to Article 752 no later than five days after the expiry of the time period provided for in paragraph 2 of this Article. If a Party fails to appoint an arbitrator from its sub-list within that time period, the co-chair of the Partnership Council from the complaining Party shall select, no later than five days after the expiry of that time period, an arbitrator by lot from the sub-list of the Party that has failed to appoint an arbitrator. The co-chair of the Partnership Council from the complaining Party may delegate such selection by lot of the arbitrator. 4. If the Parties do not agree on the chairperson of the arbitration tribunal within the time period provided for in paragraph 2 of this Article, the co-chair of the Partnership Council from the complaining Party shall select, no later than five days after the expiry of that time period, the chairperson of the arbitration tribunal by lot from the sub-list of chairpersons established pursuant to Article 752. The co-chair of the Partnership Council from the complaining Party may delegate such selection by lot of the chairperson of the arbitration tribunal. 5. Should any of the lists provided for in Article 752 not be established or not contain sufficient names at the time a selection is made pursuant to paragraph 3 or 4 of this Article, the arbitrators shall be selected by lot from the individuals who have been formally proposed by one Party or both Parties in accordance with Annex 48. 6. The date of establishment of the arbitration tribunal shall be the date on which the last of the three arbitrators has notified to the Parties the acceptance of his or her appointment in accordance with Annex 48. Article 741 Requirements for arbitrators 1. All arbitrators shall: (a) have demonstrated expertise in law and international trade, including on specific matters covered by Titles I to VII, Chapter 4 of Title VIII, Titles IX to XII of Heading One of Part Two or Heading Six of Part Two, or in law and any other matter covered by this Agreement or by any supplementing agreement and, in the case of a chairperson, also have experience in dispute settlement procedures; (b) not be affiliated with or take instructions from either Party; (c) serve in their individual capacities and not take instructions from any organisation or government with regard to matters related to the dispute; and (d) comply with Annex 49. 2. All arbitrators shall be persons whose independence is beyond doubt, who possess the qualifications required for appointment to high judicial office in their respective countries or who are jurisconsults of recognised competence. 3. In view of the subject-matter of a particular dispute, the Parties may agree to derogate from the requirements listed in point (a) of paragraph 1. Article 742 Functions of the arbitration tribunal The arbitration tribunal: (a) shall make an objective assessment of the matter before it, including an objective assessment of the facts of the case and the applicability of, and conformity of the measures at issue with, the covered provisions; (b) shall set out, in its decisions and rulings, the findings of facts and law and the rationale behind any findings that it makes; and (c) should consult regularly with the Parties and provide adequate opportunities for the development of a mutually agreed solution. Article 743 Terms of reference 1. Unless the Parties agree otherwise no later than five days after the date of the establishment of the arbitration tribunal, the terms of reference of the arbitration tribunal shall be: "to examine, in the light of the relevant covered provisions of this Agreement or of a supplementing agreement, the matter referred to in the request for the establishment of the arbitration tribunal, to decide on the conformity of the measure at issue with the provisions referred to in Article 735 and to issue a ruling in accordance with Article 745". 2. If the Parties agree on terms of reference other than those referred to in paragraph 1, they shall notify the agreed terms of reference to the arbitration tribunal within the time period referred to in paragraph 1. Article 744 Urgent proceedings 1. If a Party so requests, the arbitration tribunal shall decide, no later than 10 days after the date of its establishment, whether the case concerns matters of urgency. 2. In cases of urgency, the applicable time periods set out in Article 745 shall be half the time prescribed therein. Article 745 Ruling of the arbitration tribunal 1. The arbitration tribunal shall deliver an interim report to the Parties within 100 days after the date of establishment of the arbitration tribunal. If the arbitration tribunal considers that this deadline cannot be met, the chairperson of the arbitration tribunal shall notify the Parties in writing, stating the reasons for the delay and the date on which the arbitration tribunal plans to deliver its interim report. The arbitration tribunal shall not deliver its interim report later than 130 days after the date of establishment of the arbitration tribunal under any circumstances. 2. Each Party may deliver to the arbitration tribunal a written request to review precise aspects of the interim report within 14 days of its delivery. A Party may comment on the other Party's request within six days of the delivery of the request. 3. If no written request to review precise aspects of the interim report is delivered within the time period referred to in paragraph 2, the interim report shall become the ruling of the arbitration tribunal. 4. The arbitration tribunal shall deliver its ruling to the Parties within 130 days of the date of establishment of the arbitration tribunal. When the arbitration tribunal considers that that deadline cannot be met, its chairperson shall notify the Parties in writing, stating the reasons for the delay and the date on which the arbitration tribunal plans to deliver its ruling. The arbitration tribunal shall not deliver its ruling later than 160 days after the date of establishment of the arbitration tribunal under any circumstances. 5. The ruling shall include a discussion of any written request by the Parties on the interim report and clearly address the comments of the Parties. 6. For greater certainty, a "ruling" or "rulings" as referred to in Articles 742, 743 and 753 and Article 754(1), (3), (4) and (6) shall be understood to refer also to the interim report of the arbitration tribunal. CHAPTER 3 COMPLIANCE Article 746 Compliance measures 1. If, in its ruling referred to in Article 745(4), the arbitration tribunal finds that the respondent Party has breached an obligation under this Agreement or under any supplementing agreement, that Party shall take the necessary measures to comply immediately with the ruling of the arbitration tribunal in order to bring itself in compliance with the covered provisions. 2. The respondent Party, no later than 30 days after delivery of the ruling, shall deliver a notification to the complaining Party of the measures which it has taken or which it envisages to take in order to comply. Article 747 Reasonable Period of Time 1. If immediate compliance is not possible, the respondent Party, no later than 30 days after delivery of the ruling referred to in Article 745(4), shall deliver a notification to the complaining Party of the length of the reasonable period of time it will require for compliance with the ruling referred to in Article 745(4). The Parties shall endeavour to agree on the length of the reasonable period of time to comply. 2. If the Parties have not agreed on the length of the reasonable period of time, the complaining Party may, at the earliest 20 days after the delivery of the notification referred to in paragraph 1, request in writing that the original arbitration tribunal determines the length of the reasonable period of time. The arbitration tribunal shall deliver its decision to the Parties within 20 days of the date of delivery of the request. 3. The respondent Party shall deliver a written notification of its progress in complying with the ruling referred to in Article 745(4) to the complaining Party at least one month before the expiry of the reasonable period of time. 4. The Parties may agree to extend the reasonable period of time. Article 748 Compliance Review 1. The respondent Party shall, no later than the date of expiry of the reasonable period of time, deliver a notification to the complaining Party of any measure that it has taken to comply with the ruling referred to in Article 745(4). 2. When the Parties disagree on the existence of, or the consistency with the covered provisions of, any measure taken to comply, the complaining Party may deliver a request, which shall be in writing, to the original arbitration tribunal to decide on the matter. The request shall identify any measure at issue and explain how that measure constitutes a breach of the covered provisions in a manner sufficient to present the legal basis for the complaint clearly. The arbitration tribunal shall deliver its decision to the Parties within 45 days of the date of delivery of the request. Article 749 Temporary Remedies 1. The respondent Party shall, at the request of and after consultations with the complaining Party, present an offer for temporary compensation if: (a) the respondent Party delivers a notification to the complaining Party that it is not possible to comply with the ruling referred to in Article 745(4); or (b) the respondent Party fails to deliver a notification of any measure taken to comply within the deadline referred to in Article 746 or before the date of expiry of the reasonable period of time; or (c) the arbitration tribunal finds that no measure taken to comply exists or that the measure taken to comply is inconsistent with the covered provisions. 2. In any of the conditions referred to in points (a), (b) and (c) of paragraph 1, the complaining Party may deliver a written notification to the respondent Party that it intends to suspend the application of obligations under the covered provisions if: (a) the complaining Party decides not to make a request under paragraph 1; or (b) the Parties do not agree on the temporary compensation within 20 days after the expiry of the reasonable period of time or the delivery of the arbitration tribunal decision under Article 748 if a request under paragraph 1 of this Article is made. The notification shall specify the level of intended suspension of obligations. 3. Suspension of obligations shall be subject to the following conditions: (a) obligations under Heading Four of Part Two, the Protocol on Social Security Coordination or its annexes or Part Five may not be suspended under this Article; (b) by way of derogation from point (a), obligations under Part Five may be suspended only where the ruling referred to in Article 745(4) concerns the interpretation and implementation of Part Five; (c) obligations outside Part Five may not be suspended where the ruling referred to in Article 745(4) concerns the interpretation and implementation of Part Five; and (d) obligations under Title II of Heading One of Part Two in respect of financial services may not be suspended under this Article, unless the ruling referred to in Article 745(4) concerns the interpretation and application of obligations under Title II of Heading One of Part two in respect of financial services. 4. Where a Party persists in not complying with a ruling of an arbitration panel established under an earlier agreement concluded between the Parties, the other Party may suspend obligations under the covered provisions referred to in Article 735. With the exception of the rule in point (a) of paragraph 3 of this Article, all rules relating to temporary remedies in case of non-compliance and to review of any such measures shall be governed by the earlier agreement. 5. The suspension of obligations shall not exceed the level equivalent to the nullification or impairment caused by the violation. 6. If the arbitration tribunal has found the violation in Heading One or Heading Three of Part Two, the suspension may be applied in another Title of the same Heading as that in which the tribunal has found the violation, in particular if the complaining party is of the view that such suspension is effective in inducing compliance. 7. If the arbitration tribunal has found the violation in Heading Two of Part Two: (a) the complaining party should first seek to suspend obligations in the same Title as that in which the arbitration tribunal has found the violation; (b) if the complaining party considers that it is not practicable or effective to suspend obligations with respect to the same Title as that in which the tribunal has found the violation, it may seek to suspend obligations in the other Title under the same Heading. 8. If the arbitration tribunal has found the violation in Heading One, Heading Two, Heading Three or Heading Five of Part Two, and if the complaining party considers that it is not practicable or effective to suspend obligations within the same Heading as that in which the arbitration tribunal has found the violation, and that the circumstances are serious enough, it may seek to suspend obligations under other covered provisions. 9. In the case of point (b) of paragraph 7 and paragraph 8, the complaining Party shall state the reasons for its decision. 10. The complaining Party may suspend the obligations 10 days after the date of delivery of the notification referred to in paragraph 2 unless the respondent Party made a request under paragraph 11. 11. If the respondent Party considers that the notified level of suspension of obligations exceeds the level equivalent to the nullification or impairment caused by the violation or that the principles and procedures set forth in point (b) of paragraph 7, paragraph 8 or paragraph 9 have not been followed, it may deliver a written request to the original arbitration tribunal before the expiry of the 10 day period set out in paragraph 10 to decide on the matter. The arbitration tribunal shall deliver its decision on the level of the suspension of obligations to the Parties within 30 days of the date of the request. Obligations shall not be suspended until the arbitration tribunal has delivered its decision. The suspension of obligations shall be consistent with that decision. 12. The arbitration tribunal acting pursuant to paragraph 11 shall not examine the nature of the obligations to be suspended but shall determine whether the level of such suspension exceeds the level equivalent to the nullification or impairment caused by the violation. However, if the matter referred to arbitration includes a claim that the principles and procedures set forth in point (b) of paragraph 7, paragraph 8 or paragraph 9 have not been followed, the arbitration tribunal shall examine that claim. In the event the arbitration tribunal determines that those principles and procedures have not been followed, the complaining party shall apply them consistently with point (b) of paragraph 7, paragraph 8 and paragraph 9. The parties shall accept the arbitration tribunal's decision as final and shall not seek a second arbitration procedure. This paragraph shall under no circumstances delay the date as of which the complaining Party is entitled to suspend obligations under this Article. 13. The suspension of obligations or the compensation referred to in this Article shall be temporary and shall not be applied after: (a) the Parties have reached a mutually agreed solution pursuant to Article 756; (b) the Parties have agreed that the measure taken to comply brings the respondent Party into compliance with the covered provisions; or (c) any measure taken to comply which the arbitration tribunal has found to be inconsistent with the covered provisions has been withdrawn or amended so as to bring the respondent Party into compliance with those covered provisions. Article 750 Review of any measure taken to comply after the adoption of temporary remedies 1. The respondent Party shall deliver a notification to the complaining Party of any measure it has taken to comply following the suspension of obligations or following the application of temporary compensation, as the case may be. With the exception of cases under paragraph 2, the complaining Party shall terminate the suspension of obligations within 30 days from the delivery of the notification. In cases where compensation has been applied, with the exception of cases under paragraph 2, the respondent Party may terminate the application of such compensation within 30 days from the delivery of its notification that it has complied. 2. If the Parties do not reach an agreement on whether the notified measure brings the respondent Party into compliance with the covered provisions within 30 days of the date of delivery of the notification, the complaining Party shall deliver a written request to the original arbitration tribunal to decide on the matter. The arbitration tribunal shall deliver its decision to the Parties within 46 days of the date of the delivery of the request. If the arbitration tribunal finds that the measure taken to comply is in conformity with the covered provisions, the suspension of obligations or compensation, as the case may be, shall be terminated. When relevant, the level of suspension of obligations or of compensation shall be adjusted in light of the arbitration tribunal decision. CHAPTER 4 COMMON PROCEDURAL PROVISIONS Article 751 Receipt of information 1. On request of a Party, or on its own initiative, the arbitration tribunal may seek from the Parties relevant information it considers necessary and appropriate. The Parties shall respond promptly and fully to any request by the arbitration tribunal for such information. 2. On request of a Party, or on its own initiative, the arbitration tribunal may seek from any source any information it considers appropriate. The arbitration tribunal may also seek the opinion of experts as it considers appropriate and subject to any terms and conditions agreed by the Parties, where applicable. 3. The arbitration tribunal shall consider amicus curiae submissions from natural persons of a Party or legal persons established in a Party in accordance with Annex 48. 4. Any information obtained by the arbitration tribunal under this Article shall be made available to the Parties and the Parties may submit comments on that information to the arbitration tribunal. Article 752 Lists of arbitrators 1. The Partnership Council shall, no later than 180 days after the date of entry into force of this Agreement, establish a list of individuals with expertise in specific sectors covered by this Agreement or its supplementing agreements who are willing and able to serve as members of an arbitration tribunal. The list shall comprise at least 15 persons and shall be composed of three sub-lists: (a) one sub-list of individuals established on the basis of proposals by the Union; (b) one sub-list of individuals established on the basis of proposals by the United Kingdom; and (c) one sub-list of individuals who are not nationals of either Party who shall serve as chairperson to the arbitration tribunal. Each sub-list shall include at least five individuals. The Partnership Council shall ensure that the list is always maintained at this minimum number of individuals. 2. The Partnership Council may establish additional lists of individuals with expertise in specific sectors covered by this Agreement or by any supplementing agreement. Subject to the agreement of the Parties, such additional lists may be used to compose the arbitration tribunal in accordance with the procedure set out in Article 740(3) and (5). Additional lists shall be composed of two sub-lists: (a) one sub-list of individuals established on the basis of proposals by the Union; and (b) one sub-list of individuals established on the basis of proposals by the United Kingdom. 3. The lists referred to in paragraphs 1 and 2 shall not comprise persons who are members, officials or other servants of the Union institutions, of the Government of a Member State, or of the Government of the United Kingdom. Article 753 Replacement of arbitrators If during dispute settlement procedures under this Title, an arbitrator is unable to participate, withdraws, or needs to be replaced because that arbitrator does not comply with the requirements of the Code of Conduct, the procedure set out in Article 740 shall apply. The time period for the delivery of the ruling or decision shall be extended for the time necessary for the appointment of the new arbitrator. Article 754 Arbitration tribunal decisions and rulings 1. The deliberations of the arbitration tribunal shall be kept confidential. The arbitration tribunal shall make every effort to draft rulings and take decisions by consensus. If this is not possible, the arbitration tribunal shall decide the matter by majority vote. In no case shall separate opinions of arbitrators be disclosed. 2. The decisions and rulings of the arbitration tribunal shall be binding on the Union and on the United Kingdom. They shall not create any rights or obligations with respect to natural or legal persons. 3. Decisions and rulings of the arbitration tribunal cannot add to or diminish the rights and obligations of the Parties under this Agreement or under any supplementing agreement. 4. For greater certainty, the arbitration tribunal shall have no jurisdiction to determine the legality of a measure alleged to constitute a breach of this Agreement or of any supplementing agreement, under the domestic law of a Party. No finding made by the arbitration tribunal when ruling on a dispute between the Parties shall bind the domestic courts or tribunals of either Party as to the meaning to be given to the domestic law of that Party. 5. For greater certainty, the courts of each Party shall have no jurisdiction in the resolution of disputes between the Parties under this Agreement. 6. Each Party shall make the rulings and decisions of the arbitration tribunal publicly available, subject to the protection of confidential information. 7. The information submitted by the Parties to the arbitration tribunal shall be treated in accordance with the confidentiality rules laid down in Annex 48. Article 755 Suspension and termination of the arbitration proceedings At the request of both Parties, the arbitration tribunal shall suspend its work at any time for a period agreed by the Parties and not exceeding 12 consecutive months. The arbitration tribunal shall resume its work before the end of the suspension period at the written request of both Parties, or at the end of the suspension period at the written request of either Party. The requesting Party shall deliver a notification to the other Party accordingly. If a Party does not request the resumption of the arbitration tribunal's work at the expiry of the suspension period, the authority of the arbitration tribunal shall lapse and the dispute settlement procedure shall be terminated. In the event of a suspension of the work of the arbitration tribunal, the relevant time periods shall be extended by the same time period for which the work of the arbitration tribunal was suspended. Article 756 Mutually agreed solution 1. The Parties may at any time reach a mutually agreed solution with respect to any dispute referred to in Article 735. 2. If a mutually agreed solution is reached during panel proceedings, the Parties shall jointly notify the agreed solution to the chairperson of the arbitration tribunal. Upon such notification, the arbitration proceedings shall be terminated. 3. The solution may be adopted by means of a decision of the Partnership Council. Mutually agreed solutions shall be made publicly available. The version disclosed to the public shall not contain any information either Party has designated as confidential. 4. Each Party shall take the measures necessary to implement the mutually agreed solution within the agreed time period. 5. No later than the date of expiry of the agreed time period, the implementing Party shall inform the other Party in writing of any measures thus taken to implement the mutually agreed solution. Article 757 Time Periods 1. All time periods laid down in this Title shall be counted in days from the day following the act to which they refer. 2. Any time period referred to in this Title may be modified by mutual agreement of the Parties. 3. The arbitration tribunal may at any time propose to the Parties to modify any time period referred to in this Title, stating the reasons for the proposal. Article 758 Costs 1. Each Party shall bear its own expenses derived from the participation in the arbitration tribunal procedure. 2. The Parties shall share jointly and equally the expenses derived from organisational matters, including the remuneration and expenses of the members of the arbitration tribunal. The remuneration of the arbitrators shall be in accordance with Annex 48. Article 759 Annexes 1. Dispute settlement procedures set out in this Title shall be governed by the rules of procedure set out in Annex 48 and conducted in accordance with Annex 49. 2. The Partnership Council may amend Annexes 48 and 49. CHAPTER 5 SPECIFIC ARRANGEMENTS FOR UNILATERAL MEASURES Article 760 Special procedures for remedial measures and rebalancing 1. For the purposes of Article 374 and Article 411(2) and (3), this Title applies with the modifications set out in this Article. 2. By way of derogation from Article 740 and Annex 48, if the Parties do not agree on the composition of the arbitration tribunal within two days, the co-chair of the Partnership Council from the complaining Party shall select, no later than one day after the expiry of the two-day time period, an arbitrator by lot from the sub-list of each Party and the chairperson of the arbitration tribunal by lot from the sub-list of chairpersons established pursuant to Article 752. The co-chair of the Partnership Council from the complaining Party may delegate such selection by lot of the arbitrator or chairperson. Each individual shall confirm his or her availability to both Parties within two days from the date on which he or she was informed of his or her appointment. The organisational meeting referred to in Rule 10 of Annex 48 shall take place within two days from the establishment of the arbitration tribunal. 3. By way of derogation from Rule 11 of Annex 48 the complaining Party shall deliver its written submission no later than seven days after the date of establishment of the arbitration tribunal. The respondent Party shall deliver its written submission no later than seven days after the date of delivery of the written submission of the complaining Party. The arbitration tribunal shall adjust any other relevant time periods of the dispute settlement procedure as necessary to ensure the timely delivery of the report. 4. Article 745 does not apply and references to the ruling in this Title shall be read as references to the ruling referred to in Article 374(10) or point (c) of Article 411(3). 5. By way of derogation from Article 748(2), the arbitration tribunal shall deliver its decision to the Parties within 30 days from the date of delivery of the request. Article 761 Suspension of obligations for the purposes of Article 374(12), Article 501(5) and Article 506(7) 1. The level of suspension of obligations shall not exceed the level equivalent to the nullification or impairment of benefits under this Agreement or under a supplementing agreement that is directly caused by the remedial or compensatory measures from the date the remedial or compensatory measures enter into effect until the date of the delivery of the arbitration ruling. 2. The level of suspension of obligations requested by the complaining Party and the determination of the level of suspension of obligations by the arbitration tribunal shall be based on facts demonstrating that the nullification or impairment arises directly from the application of the remedial or compensatory measure and affects specific goods, service suppliers, investors or other economic actors and not merely on allegation, conjecture or remote possibility. 3. The level of nullified or impaired benefits requested by the complaining Party or determined by the arbitration tribunal: (a) shall not include punitive damages, interest or hypothetical losses of profits or business opportunities; (b) shall be reduced by any prior refunds of duties, indemnification of damages or other forms of compensation already received by the concerned operators or the concerned Party; and (c) shall not include the contribution to the nullification or impairment by wilful or negligent action or omission of the concerned Party or any person or entity in relation to whom remedies are sought pursuant to the intended suspension of obligations. Article 762 Conditions for rebalancing, remedial, compensatory and safeguard measures Where a Party takes a measure under Article 374, Article 411, Article 469, Article 501, Article 506 or Article 773, that measure shall only be applied in respect of covered provisions within the meaning of Article 735 and shall comply, mutatis mutandis, with the conditions set out in Article 749(3). TITLE II BASIS FOR COOPERATION Article 763 Democracy, rule of law and human rights 1. The Parties shall continue to uphold the shared values and principles of democracy, the rule of law, and respect for human rights, which underpin their domestic and international policies. In that regard, the Parties reaffirm their respect for the Universal Declaration of Human Rights and the international human rights treaties to which they are parties. 2. The Parties shall promote such shared values and principles in international forums. The Parties shall cooperate in promoting those values and principles, including with or in third countries. Article 764 Fight against climate change 1. The Parties consider that climate change represents an existential threat to humanity and reiterate their commitment to strengthening the global response to this threat. The fight against human-caused climate change as elaborated in the United Nations Framework Convention on Climate Change ("UNFCCC") process, and in particular in the Paris Agreement adopted by the Conference of the Parties to the United Nations Framework Convention on Climate Change at its 21st session (the "Paris Agreement"), inspires the domestic and external policies of the Union and the United Kingdom. Accordingly, each Party shall respect the Paris Agreement and the process set up by the UNFCCC and refrain from acts or omissions that would materially defeat the object and purpose of the Paris Agreement. 2. The Parties shall advocate the fight against climate change in international forums, including by engaging with other countries and regions to increase their level of ambition in the reduction of greenhouse emissions. Article 765 Countering proliferation of weapons of mass destruction 1. The Parties consider that the proliferation of weapons of mass destruction ("WMD") and their means of delivery, to both state and non-state actors, represents one of the most serious threats to international stability and security. The Parties therefore agree to cooperate and to contribute to countering the proliferation of weapons of mass destruction and their means of delivery through full compliance with and national implementation of existing obligations under international disarmament and non-proliferation treaties and agreements and other relevant international obligations. 2. The Parties, furthermore, agree to cooperate on and to contribute to countering the proliferation of weapons of mass destruction and their means of delivery by: (a) taking steps to sign, ratify, or accede to, as appropriate, and fully implement all other relevant international instruments; and (b) establishing an effective system of national export controls, controlling the export as well as transit of WMD-related goods, including a WMD end-use control on dual use technologies and containing effective sanctions for breaches of export controls. 3. The Parties agree to establish a regular dialogue on those matters. Article 766 Small arms and light weapons and other conventional weapons 1. The Parties recognise that the illicit manufacture, transfer and circulation of small arms and light weapons ("SALW"), including their ammunition, their excessive accumulation, their poor management, inadequately secured stockpiles and their uncontrolled spread continue to pose a serious threat to peace and international security. 2. The Parties agree to observe and fully implement their respective obligations to deal with the illicit trade in SALW, including their ammunition, under existing international agreements and UN Security Council resolutions, as well as their respective commitments within the framework of other international instruments applicable in this area, such as the UN Programme of Action to prevent, combat and eradicate the illicit trade in SALW in all its aspects. 3. The Parties recognise the importance of domestic control systems for the transfer of conventional arms in line with existing international standards. The Parties recognise the importance of applying such controls in a responsible manner, as a contribution to international and regional peace, security and stability, and to the reduction of human suffering, as well as to the prevention of diversion of conventional weapons. 4. The Parties undertake, in that regard, to fully implement the Arms Trade Treaty and to cooperate with each other within the framework of that Treaty, including in promoting the universalisation and full implementation of that Treaty by all UN member states. 5. The Parties therefore undertake to cooperate in their efforts to regulate or improve the regulation of international trade in conventional arms and to prevent, combat and eradicate the illicit trade in arms. 6. The Parties agree to establish a regular dialogue on those matters. Article 767 The most serious crimes of concern to the international community 1. The Parties reaffirm that the most serious crimes of concern to the international community as a whole must not go unpunished and that their effective prosecution must be ensured by taking measures at the national level and by enhancing international cooperation, including with the International Criminal Court. The Parties agree to fully support the universality and integrity of the Rome Statute of the International Criminal Court and related instruments. 2. The Parties agree to establish a regular dialogue on those matters. Article 768 Counter-terrorism 1. The Parties shall cooperate at the bilateral, regional and international levels to prevent and combat acts of terrorism in all its forms and manifestations in accordance with international law, including, where applicable, international counterterrorism-related agreements, international humanitarian law and international human rights law, as well as in accordance with the principles of the Charter of the United Nations. 2. The Parties shall enhance cooperation on counter-terrorism, including preventing and countering violent extremism and the financing of terrorism, with the aim of advancing their common security interests, taking into account, the United Nations Global Counter-Terrorism Strategy and relevant United Nations Security Council resolutions, without prejudice to law enforcement and judicial cooperation in criminal matters and intelligence exchanges. 3. The Parties agree to establish a regular dialogue on those matters. This dialogue will, inter alia, aim to promote and facilitate: (a) the sharing of assessments on the terrorist threat; (b) the exchange of best practices and expertise on counter terrorism; (c) operational cooperation and exchange of information; and (d) exchanges on cooperation in the framework of multilateral organisations. Article 769 Personal data protection 1. The Parties affirm their commitment to ensuring a high level of personal data protection. They shall endeavour to work together to promote high international standards. 2. The Parties recognise that individuals have a right to the protection of personal data and privacy and that high standards in this regard contribute to trust in the digital economy and to the development of trade, and are a key enabler for effective law enforcement cooperation. To that end, the Parties shall undertake to respect, each in the framework of their respective laws and regulations, the commitments they have made in this Agreement in connection with that right. 3. The Parties shall cooperate at bilateral and multilateral levels, while respecting their respective laws and regulations. Such cooperation may include dialogue, exchanges of expertise, and cooperation on enforcement, as appropriate, with respect to personal data protection. 4. Where this Agreement or any supplementing agreement provide for the transfer of personal data, such transfer shall take place in accordance with the transferring Party's rules on international transfers of personal data. For greater certainty, this paragraph is without prejudice to the application of any specific provisions in this Agreement relating to the transfer of personal data, in particular Article 202 and Article 525, and to Title I of Part Six. Where needed, each Party will make best efforts, while respecting its rules on international transfers of personal data, to establish safeguards necessary for the transfer of personal data, taking into account any recommendations of the Partnership Council under point (h) of Article 7(4). Article 770 Global cooperation on issues of shared economic, environmental and social interest 1. The Parties recognise the importance of global cooperation to address issues of shared economic, environmental and social interest. Where it is in their mutual interest, they shall promote multilateral solutions to common problems. 2. While preserving their decision-making autonomy, and without prejudice to other provisions of this Agreement or any supplementing agreement, the Parties shall endeavour to cooperate on current and emerging global issues of common interest such as peace and security, climate change, sustainable development, cross-border pollution, environmental protection, digitalisation, public health and consumer protection, taxation, financial stability, and free and fair trade and investment. To that end, they shall endeavour to maintain a constant and effective dialogue and to coordinate their positions in multilateral organisations and forums in which the Parties participate, such as the United Nations, the Group of Seven (G-7) and the Group of Twenty (G-20), the Organisation for Economic Co-operation and Development, the International Monetary Fund, the World Bank and the World Trade Organization. Article 771 Essential elements Article 763(1), Article 764(1) and Article 765(1) constitute essential elements of the partnership established by this Agreement and any supplementing agreement. TITLE III FULFILLMENT OF OBLIGATIONS AND SAFEGUARD MEASURES Article 772 Fulfilment of obligations described as essential elements 1. If either Party considers that there has been a serious and substantial failure by the other Party to fulfil any of the obligations that are described as essential elements in Article 771, it may decide to terminate or suspend the operation of this Agreement or any supplementing agreement in whole or in part. 2. Before doing so, the Party invoking the application of this Article shall request that the Partnership Council meet immediately with a view to seeking a timely and mutually agreeable solution. If no mutually agreeable solution is found within 30 days from the date of the request to the Partnership Council, the Party may take the measures referred to in paragraph 1. 3. The measures referred to in paragraph 1 shall be in full respect of international law and shall be proportionate. Priority shall be given to the measures which least disturb the functioning of this Agreement and of any supplementing agreements. 4. The Parties consider that, for a situation to constitute a serious and substantial failure to fulfil any of the obligations described as essential elements in Article 771, its gravity and nature would have to be of an exceptional sort that threatens peace and security or that has international repercussions. For greater certainty, an act or omission which materially defeats the object and purpose of the Paris Agreement shall always be considered as a serious and substantial failure for the purposes of this Article. Article 773 Safeguard measures 1. If serious economic, societal or environmental difficulties of a sectorial or regional nature, including in relation to fishing activities and their dependent communities, that are liable to persist arise, the Party concerned may unilaterally take appropriate safeguard measures. Such safeguard measures shall be restricted with regard to their scope and duration to what is strictly necessary in order to remedy the situation. Priority shall be given to those measures which will least disturb the functioning of this Agreement. 2. The Party concerned shall, without delay, notify the other Party through the Partnership Council and shall provide all relevant information. The Parties shall immediately enter into consultations in the Partnership Council with a view to finding a mutually agreeable solution. 3. The Party concerned may not take safeguard measures until one month has elapsed after the date of notification referred to in paragraph 2, unless the consultation procedure pursuant to paragraph 2 has been jointly concluded before the expiration of the stated time limit. When exceptional circumstances requiring immediate action exclude prior examination, the Party concerned may apply forthwith the safeguard measures strictly necessary to remedy the situation. The Party concerned shall, without delay, notify the measures taken to the Partnership Council and shall provide all relevant information. 4. If a safeguard measure taken by the Party concerned creates an imbalance between the rights and obligations under this Agreement or under any supplementing agreement, the other Party may take such proportionate rebalancing measures as are strictly necessary to remedy the imbalance. Priority shall be given to those measures which will least disturb the functioning of this Agreement. Paragraphs 2 to 4 shall apply mutatis mutandis to such rebalancing measures. 5. Either Party may, without having prior recourse to consultations pursuant to Article 738, initiate the arbitration procedure referred to in Article 739 to challenge a measure taken by the other Party in application of paragraphs 1 to 5 of this Article. 6. The safeguard measures referred to in paragraph 1 and the rebalancing measures referred to in paragraph 5 may also be taken in relation to a supplementing agreement, unless otherwise provided therein. PART SEVEN FINAL PROVISIONS Article 774 Territorial scope 1. This Agreement applies to: (a) the territories to which the TEU, the TFEU and the Treaty establishing the European Atomic Energy Community are applicable, and under the conditions laid down in those Treaties; and (b) the territory of the United Kingdom. 2. This Agreement also applies to the Bailiwick of Guernsey, the Bailiwick of Jersey and the Isle of Man to the extent set out in Heading Five of Part Two and Article 520. 3. This Agreement shall neither apply to Gibraltar nor have any effects in that territory. 4. This Agreement does not apply to the overseas territories having special relations with the United Kingdom: Anguilla; Bermuda; British Antarctic Territory; British Indian Ocean Territory; British Virgin Islands; Cayman Islands; Falkland Islands; Montserrat; Pitcairn, Henderson, Ducie and Oeno Islands; Saint Helena, Ascension and Tristan da Cunha; South Georgia and the South Sandwich Islands; and Turks and Caicos Islands. Article 775 Relationship with other agreements This Agreement and any supplementing agreement apply without prejudice to any earlier bilateral agreement between the United Kingdom of the one part and the Union and the European Atomic Energy Community of the other part. The Parties reaffirm their obligations to implement any such Agreement. Article 776 Review The Parties shall jointly review the implementation of this Agreement and supplementing agreements and any matters related thereto five years after the entry into force of this Agreement and every five years thereafter. Article 777 Classified information and sensitive non-classified information Nothing in this Agreement or in any supplementing agreement shall be construed as requiring a Party to make available classified information. Classified information or material provided by or exchanged between the Parties under this Agreement or any supplementing agreement shall be handled and protected in compliance with the Agreement on security procedures for exchanging and protecting classified information and any implementing arrangement concluded under it. The Parties shall agree upon handling instructions to ensure the protection of sensitive non-classified information exchanged between them. Article 778 Integral parts of this Agreement 1. The Protocols, Annexes, Appendices and footnotes to this Agreement shall form an integral part of this Agreement. 2. Each of the Annexes to this Agreement, including its appendices, shall form an integral part of the Section, Chapter, Title, Heading or Protocol that refers to that Annex or to which reference is made in that Annex. For greater certainty: (a) Annex 1 forms an integral part of Title III of Part One; (b) Annexes 2, 3, 4, 5, 6, 7, 8 and 9 form an integral part of Chapter 2 of Title I of Heading One of Part Two; (c) Annex 10 forms an integral part of Chapter 3 of Title I of Heading One of Part Two; (d) Annexes 11, 12, 13, 14, 15, 16 and 17 form an integral part of Chapter 4 of Title I of Heading One of Part Two; (e) Annex 18 forms an integral part of Chapter 5 of Title I of Heading One of Part Two; (f) Annexes 19, 20, 21, 22, 23 and 24 form an integral part of Title II of Heading One of Part Two; (g) Annex 25 forms an integral part of Title VI of Heading One of Part Two; (h) Annexes 26, 27, 28 and 29 form an integral part of Title VIII of Heading One of Part Two; (i) Annex 27 forms an integral part of Title XI of Heading One of Part Two; (j) Annex 30 and any annex adopted in accordance with Article 454 form an integral part of Title Two of Heading Two of Part Two; (k) Annex 31 forms an integral part of Title I of Heading Three of Part Two; (l) Annexes 32, 33 and 34 form an integral part of Title II of Heading Three of Part Two; (m) Annexes 35, 36, 37 and 38 form an integral part of Heading Five of Part Two; (n) Annex 39 forms an integral part of Title II of Part Three; (o) Annex 40 forms an integral part of Title III of Part Three; (p) Annex 41 forms an integral part of Title V of Part Three; (q) Annex 42 forms an integral part of Title VI of Part Three; (r) Annex 43 forms an integral part of Title VII of Part Three; (s) Annex 44 forms an integral part of Title IX of Part Three; (t) Annex 45 forms an integral part of Title III, Title VII and Title XI of Part Three; (u) Annex 46 forms an integral part of Title XI of Part Three; (v) Annex 47 forms an integral part of Section 2 of Chapter 1 of Part Five; (w) Annexes 48 and 49 form an integral part of Title I of Part Six; (x) the Annex to the protocol on administrative cooperation and combating fraud in the field of value added tax and on mutual assistance for the recovery of claims relating to taxes and duties forms an integral part of the Protocol on administrative cooperation and combating fraud in the field of value added tax and on mutual assistance for the recovery of claims relating to taxes and duties; (y) Annexes SSC-1, SSC-2, SSC-3, SSC-4, SSC-5, SSC-6, SSC-7 and SSC-8 and their Appendices form an integral part of the Protocol on Social Security Coordination. Article 779 Termination Either Party may terminate this Agreement by written notification through diplomatic channels. This Agreement and any supplementing agreement shall cease to be in force on the first day of the twelfth month following the date of notification. Article 780 Authentic texts This Agreement shall be drawn up in duplicate in the Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish languages. By 30 April 2021, all language versions of the Agreement shall be subject to a process of final legal-linguistic revision. Notwithstanding the previous sentence, the process of final legal-linguistic revision for the English version of the Agreement shall be finalised at the latest by the day referred to in Article 783(1) if that day is earlier than 30 April 2021. The language versions resulting from the above process of final legal-linguistic revision shall replace ab initio the signed versions of the Agreement and shall be established as authentic and definitive by exchange of diplomatic notes between the Parties. Article 781 Future accessions to the Union 1. The Union shall notify the United Kingdom of any new request for accession of a third country to the Union. 2. During the negotiations between the Union and a third country regarding the accession of that country to the Union (87), the Union shall endeavour to: (a) on request of the United Kingdom and, to the extent possible, provide any information regarding any matter covered by this Agreement and any supplementing agreement; and (b) take into account any concerns expressed by the United Kingdom. 3. The Partnership Council shall examine any effects of accession of a third country to the Union on this Agreement and any supplementing agreement sufficiently in advance of the date of such accession. 4. To the extent necessary, the United Kingdom and the Union shall, before the entry into force of the agreement on the accession of a third country to the Union: (a) amend this Agreement or any supplementing agreement, (b) put in place by decision of the Partnership Council any other necessary adjustments or transitional arrangements regarding this Agreement or any supplementing agreement; or (c) decide within the Partnership Council whether: (i) to apply Article 492 to the nationals of that third country; or (ii) to establish transitional arrangements as regards Article 492 in relation to that third country and its nationals once it accedes to the Union. 5. In the absence of a decision under point (c)(i) or (ii) of paragraph 4 of this Article by the entry into force of the agreement on the accession of the relevant third country to the Union, Article 492 shall not apply to nationals of that third country. 6. In the event that the Partnership Council establishes transitional arrangements as referred to in point (c)(ii) of paragraph 4, it shall specify their duration. The Partnership Council may extend the duration of those transitional arrangements. 7. Before the expiry of the transitional arrangements referred to in point (c)(ii) of paragraph 4 of this Article, the Partnership Council shall decide whether to apply Article 492 to the nationals of that third country from the end of the transitional arrangements. In the absence of such a decision Article 492 shall not apply in relation to the nationals of that third country from the end of the transitional arrangements. 8. Point (c) of paragraph 4, and paragraphs 5 to 7 are without prejudice to the Union's prerogatives under its domestic legislation. 9. For greater certainty, without prejudice to point (c) of paragraph 4 and paragraphs 5 to 7, this Agreement shall apply in relation to a new Member State of the Union from the date of accession of that new Member State to the Union. Article 782 Interim provision for transmission of personal data to the United Kingdom 1. For the duration of the specified period, transmission of personal data from the Union to the United Kingdom shall not be considered as a transfer to a third country under Union law, provided that the data protection legislation of the United Kingdom on 31 December 2020, as it is saved and incorporated into United Kingdom law by the European Union (Withdrawal) Act 2018 and as modified by the Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019 (SI 2019/419) (88) (the "applicable data protection regime"), applies and provided that the United Kingdom does not exercise the designated powers without the agreement of the Union within the Partnership Council. 2. Subject to paragraphs 3 to 11, paragraph 1 shall also apply in respect of transfers of personal data from Iceland, the Principality of Liechtenstein and the Kingdom of Norway to the United Kingdom during the specified period made under Union law as applied in those states by the Agreement on the European Economic Area done at Porto on 2 May 1992, for so long as paragraph 1 applies to transfers of personal data from the Union to the United Kingdom, provided that those states notify both Parties in writing of their express acceptance to apply this provision. 3. For the purposes of this Article, the "designated powers" means the powers: (a) to make regulations pursuant to sections 17A, 17C and 74A of the UK Data Protection Act 2018; (b) to issue a new document specifying standard data protection clauses pursuant to section 119A of the UK Data Protection Act 2018; (c) to approve a new draft code of conduct pursuant to Article 40(5) of the UK General Data Protection Regulation ("UK GDPR"), other than a code of conduct which cannot be relied on to provide appropriate safeguards for transfers of personal data to a third country under Article 46(2)(e) of the UK GDPR; (d) to approve new certification mechanisms pursuant to Article 42(5) of the UK GDPR, other than certification mechanisms which cannot be relied on to provide appropriate safeguards for transfers of personal data to a third country under Article 46(2)(f) of the UK GDPR; (e) to approve new binding corporate rules pursuant to Article 47 of the UK GDPR; (f) to authorise new contractual clauses referred to in Article 46(3)(a) of the UK GDPR; or (g) to authorise new administrative arrangements referred to in Article 46(3)(b) of the UK GDPR. 4. The "specified period" begins on the date of entry into force of this Agreement and, subject to paragraph 5, ends on one of the following dates, whichever is earlier: (a) on the date on which adequacy decisions in relation to the United Kingdom are adopted by the European Commission under Article 36(3) of Directive (EU) 2016/680 and under Article 45(3) of Regulation (EU) 2016/679, or (b) on the date four months after the date on which the specified period begins, which period shall be extended by two further months unless one of the Parties objects. 5. Subject to paragraphs 6 and 7, if, during the specified period, the United Kingdom amends the applicable data protection regime or exercises the designated powers without the agreement of the Union within the Partnership Council, the specified period shall end on the date on which the powers are exercised or the amendment comes into force. 6. The references to exercising the designated powers in paragraphs 1 and 5 do not include the exercise of such powers the effect of which is limited to alignment with the relevant Union data protection law. 7. Anything that would otherwise be an amendment to the applicable data protection regime which is: (a) made with the agreement of the Union within the Partnership Council; or (b) limited to alignment with the relevant Union data protection law; shall not be treated as an amendment to the applicable data protection regime for the purposes of paragraph 5 and instead should be treated as being part of the applicable data protection regime for the purposes of paragraph 1. 8. For the purposes of paragraphs 1, 5 and 7, "the agreement of the Union within the Partnership Council" means: (a) a decision of the Partnership Council as described in paragraph 11; or (b) deemed agreement as described in paragraph 10. 9. Where the United Kingdom notifies the Union that it proposes to exercise the designated powers or proposes to amend the applicable data protection regime, either party may request, within five working days, a meeting of the Partnership Council which must take place within two weeks of such request. 10. If no such meeting is requested, the Union is deemed to have given agreement to such exercise or amendment during the specified period. 11. If such a meeting is requested, at that meeting the Partnership Council shall consider the proposed exercise or amendment and may adopt a decision stating that it agrees to the exercise or amendment during the specified period. 12. The United Kingdom shall, as far as is reasonably possible, notify the Union when, during the specified period, it enters into a new instrument which can be relied on to transfer personal data to a third country under Article 46(2)(a) of the UK GDPR or section 75(1)(a) of the UK Data Protection Act 2018 during the specified period. Following a notification by the United Kingdom under this paragraph, the Union may request a meeting of the Partnership Council to discuss the relevant instrument. 13. Title I of Part Six does not apply in respect of disputes regarding the interpretation and application of this Article. Article 783 Entry into force and provisional application 1. This Agreement shall enter into force on the first day of the month following that in which both Parties have notified each other that they have completed their respective internal requirements and procedures for establishing their consent to be bound. 2. The Parties agree to provisionally apply this Agreement from 1 January 2021 provided that prior to that date they have notified each other that their respective internal requirements and procedures necessary for provisional application have been completed. Provisional application shall cease on one of the following dates, whichever is the earliest: (a) 28 February 2021 or another date as decided by the Partnership Council; or (b) the day referred to in paragraph 1. 3. As from the date from which this Agreement is provisionally applied, the Parties shall understand references in this Agreement to "the date of entry into force of this Agreement" or to "the entry into force of this Agreement" as references to the date from which this Agreement is provisionally applied. Съставено в Брюксел и Лондон на тридесети декември две хиляди и двадесета година. Hecho en Bruselas y Londres, el treinta de diciembre de dos mil veinte. V Bruselu a v Londýně dne třicátého prosince dva tisíce dvacet. Udfærdiget i Bruxelles og London, den tredivte december to tusind og tyve. Geschehen zu Brüssel und London am dreißigsten Dezember zweitausendzwanzigt. Kahe tuhande kahekümnenda aasta detsembrikuu kolmekümnendal päeval Brüsselis ja Londonis. Έγινε στις Βρυξέλλες και στο Λονδίνο, στις τριάντα Δεκεμβρίου δύο χιλιάδες είκοσι. Done at Brussels and London on the thirtieth day of December in the year two thousand and twenty. Fait à Bruxelles et à Londres, le trente décembre deux mille vingt. Arna dhéanamh sa Bhruiséil agus i Londain, an tríochadú lá de mhí na Nollag an bhliain dhá mhíle fiche. Sastavljeno u Bruxellesu i Londonu tridesetog prosinca godine dvije tisuće dvadesete. Fatto a Bruxelles e Londra, addì trenta dicembre duemilaventi. Briselē un Londonā, divi tūkstoši divdesmitā gada trīsdesmitajā decembrī. Priimta du tūkstančiai dvidešimtų metų gruodžio trisdešimtą dieną Briuselyje ir Londone. Kelt Brüsszelben és Londonban, a kétezer-huszadik év december havának harmincadik napján. Magħmul fi Brussell u Londra, fit-tletin jum ta’ Diċembru fis-sena elfejn u għoxrin. Gedaan te Brussel en Londen, dertig december tweeduizend twintig. Sporządzono w Brukseli i Londynie dnia trzydziestego grudnia roku dwa tysiące dwudziestego. Feito em Bruxelas e em Londres, em trinta de dezembro de dois mil e vinte. Întocmit la Bruxelles și la Londra la treizeci decembrie două mii douăzeci. V Bruseli a Londýne tridsiateho decembra dvetisícdvadsať. V Bruslju in Londonu, tridesetega decembra dva tisoč dvajset. Tehty Brysselissä ja Lontoossa kolmantenakymmenentenä päivänä joulukuuta vuonna kaksituhattakaksikymmentä. Som skedde i Bryssel och i London den trettionde december år tjugohundratjugo. (1) For the purpose of this Article, interested parties shall be defined as per Article 6.11 of the Anti-dumping Agreement and Article 12.9 of the SCM Agreement. (2) Preserving operations such as chilling, freezing or ventilating are considered insufficient within the meaning of point (a), whereas operations such as pickling, drying or smoking that are intended to give a product special or different characteristics are not considered insufficient. (3) The period will be of 12 months for requests of information pursuant to Article 62(2) addressed to the customs authority of the exporting Party during the first three months of the application of this Agreement. (4) G/TBT/9, 13 November 2000, Annex 4. (5) For greater certainty, it is understood that, in particular for the purposes of this Chapter, the notion of "person" includes any association of persons lacking the legal status of a legal person but recognized under applicable law as having the capacity to perform legal acts. (6) Air services or related services in support of air services include, but are not limited to, the following services: air transportation; services provided by using an aircraft whose primary purpose is not the transportation of goods or passengers, such as aerial fire-fighting, flight training, sightseeing, spraying, surveying, mapping, photography, parachute jumping, glider towing, helicopter-lift for logging and construction, and other airborne agricultural, industrial and inspection services; the rental of aircraft with crew; and airport operation services. (7) National maritime cabotage covers: for the Union, without prejudice to the scope of activities that may be considered cabotage under the relevant national legislation, transportation of passengers or goods between a port or point located in a Member State and another port or point located in that same Member State, including on its continental shelf, as provided for in the United Nations Convention on the Law of the Sea and traffic originating and terminating in the same port or point located in a Member State; for the United Kingdom, transportation of passengers or goods between a port or point located in the United Kingdom and another port or point located in the United Kingdom, including on its continental shelf, as provided for in the United Nations Convention on the Law of the Sea and traffic originating and terminating in the same port or point located in the United Kingdom. (8) For greater certainty, the term "activities performed in the exercise of governmental authority" when used in relation to measures of a Party affecting the supply of services, includes "services supplied in the exercise of governmental authority" as defined in point (p) of Article 124. (9) For greater certainty, the shipping companies referred to in this point are only considered as legal persons of a Party with respect to their activities relating to the supply of maritime transport services. (10) Points (a)(i) to (iii) of Article 128 do not cover measures taken in order to limit the production of an agricultural or fishery product. (11) Point (a)(iii) of Article 128 does not cover measures by a Party which limit inputs for the supply of services. (12) For greater certainty, point (f) of Article 132(1) is without prejudice to the provisions of Article 207. (13) Point (a) (iii) of Article 135 does not cover measures by a Party which limit inputs for the supply of services. (14) Where the degree or qualification has not been obtained in the Party where the service is supplied, that Party may evaluate whether this is equivalent to a university degree required in its territory. (15) Where the degree or qualification has not been obtained in the Party where the service is supplied, that Party may evaluate whether this is equivalent to a university degree required in its territory. (16) Managers and specialists may be required to demonstrate they possess the professional qualifications and experience needed in the legal person to which they are transferred. (17) While managers do not directly perform tasks concerning the actual supply of the services, this does not prevent them, in the course of executing their duties as described above, from performing such tasks as may be necessary for the provision of the services. (18) The recipient enterprise may be required to submit a training programme covering the duration of the stay for prior approval, demonstrating that the purpose of the stay is for training. For AT, CZ, DE, FR, ES, HU and LT, training must be linked to the university degree which has been obtained. (19) Balancing resource constraints against the potential burden on businesses, in cases where it is reasonable to do so, competent authorities may require that all information is submitted in a specified format to consider it "complete for the purposes of processing". (20) Competent authorities may meet the requirement set out in point (ii) by informing an applicant in advance in writing, including through a published measure, that a lack of response after a specified period of time from the date of submission of the application indicates acceptance of the application. The reference to "in writing" should be understood as including electronic format. (21) Such "opportunity" does not require a competent authority to provide extensions of deadlines. (22) Competent authorities are not responsible for delays due to reasons outside their competence. (23) For greater certainty, this Article shall not be construed to prevent the negotiation and conclusion of one or more agreements between the Parties on the recognition of professional qualifications on conditions and requirements different from those provided for in this Article. (24) For greater certainty, such arrangements shall not lead to the automatic recognition of qualifications but shall set, in the mutual interest of both Parties, the conditions for the competent authorities granting recognition. (25) Information requested shall be treated in accordance with the requirements of confidentiality. (26) Administrative fees do not include payments for rights to use scarce resources and mandated contributions to universal service provision. (27) For the purposes of this Article, "non-discriminatory" means most-favoured-nation and national treatment as defined in Articles 129, 130, 136 and 137, as well as under terms and conditions no less favourable than those accorded to any other user of like public telecommunications networks or services in like situations. (28) This Article does not apply to intra-European Union roaming services, which are commercial mobile services provided pursuant to a commercial agreement between suppliers of public telecommunications services that enable an end user to use its home mobile handset or other device for voice, data or messaging services in a Member State other than that in which the end user's home public telecommunications network is located. (29) For greater certainty, this modification applies to "services supplied in the exercise of governmental authority" in point (o) of Article 124 as it applies to "activities performed in the exercise of governmental authority" in point (f) of Article 124. (30) For greater certainty, this shall not prevent a Party from adopting or maintaining measures for prudential reasons in relation to branches established in its territory by legal persons in the other Party. (31) For greater certainty, for the purposes of this Title, Union law is part of the home jurisdiction law of the lawyers referred to in point (e)(i) of this Article. (32) "Legal arbitration, conciliation and mediation services" means the preparation of documents to be submitted to, the preparation for and appearance before, an arbitrator, conciliator or mediator in any dispute involving the application and interpretation of law. It does not include arbitration, conciliation and mediation services in disputes not involving the application and interpretation of law, which fall under services incidental to management consulting. It also does not include acting as an arbitrator, conciliator or mediator. As a sub-category, international legal arbitration, conciliation or mediation services refers to the same services when the dispute involves parties from two or more countries. (33) For greater certainty, for the purposes of this paragraph "designated legal services" means, for services supplied in the Union, legal services in relation to the law of the United Kingdom or any part of it and public international law (excluding Union law), and for services supplied in the United Kingdom, legal services in relation to the law of the Member States (including Union law) and public international law (excluding Union law). (34) For greater certainty, "conditions of general application" refer to conditions formulated in objective terms that apply horizontally to an unidentified number of economic operators and thus cover a range of situations and cases. (35) For greater certainty, serious balance of payments or external financial difficulties, or threat thereof, may be caused among other factors by serious difficulties related to monetary or exchange rate policies, or threat thereof. (36) Each Party may determine the relevant date of filing of the application in accordance with its own legislation. (37) This section does not apply to the protection known in the United Kingdom as a design right. (38) For the purposes of this Title, the term "plant protection product" shall be defined for each Party by the respective legislations of the Parties. (39) For greater certainty, and in so far as permitted by the law of a Party, the term "federations and associations" includes at least collective rights management bodies and professional defence bodies which are regularly recognised as having the right to represent holders of intellectual property rights. (40) For the Union the competent authority means the customs authorities. (41) For greater certainty, application of the national treatment obligation provided for in this Article is subject to the exceptions referred to in note 3 of the Notes of Sub-sections B1 and B2 of Section B of Annex 25. (42) Regulation (EU) 2019/942 of the European Parliament and of the Council of 5 June 2019 establishing a European Union Agency for the Cooperation of Energy Regulators (OJ EU L 158, 14.6.2019, p. 22). (43) Regulation (EU) 2019/943 of the European Parliament and of the Council of 5 June 2019 on the internal market for electricity (OJ EU L 158, 14.6.2019, p. 54) or its predecessors: OJ EU L 176, 15.7.2003, p.1 and OJ EU L 211, 14.8.2009, p. 15. (44) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas (OJ EU L 211, 14.8.2009, p. 94) or its predecessor: OJ EU L 176, 15.7.2003, p. 57. (45) Commission Regulation (EU) No 838/2010 of 23 September 2010 on laying down guidelines relating to the inter-transmission system operator compensation mechanism and a common regulatory approach to transmission charging (OJ EU L 250, 24.9.2010, p. 5). (46) Regulation (EC) No 715/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the natural gas transmission networks and repealing Regulation (EC) No 1775/2005 (OJ EU L 211, 14.8.2009, p. 36). (47) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ EU L 328, 21.12.2018, p. 82). (48) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency (OJ EU L 315, 14.11.2012, p.1). (49) For the Union, such principles include the precautionary principle. (50) For the United Kingdom, "small and medium-sized enterprises" means small and micro-sized businesses. (51) In the case of the United Kingdom, major regulatory measures shall be understood as significant regulatory measures in accordance with the definition of such measures in the United Kingdom's rules and procedures. (52) For greater certainty, in relation to the implementation of this Agreement in the territory of the Union, the precautionary approach refers to the precautionary principle. (53) For this purpose, discrimination means that there is less favourable treatment of an economic actor compared with others in like situations and that that differential treatment is not justified by objective criteria. (54) For greater certainty, this standard is met when the facts demonstrate that the granting of a subsidy, without having been made legally contingent upon export performance, is in fact tied to actual or anticipated exportation or export earnings. The mere fact that a subsidy is granted to economic actors which export shall not for that reason alone be considered to be an export subsidy within the meaning of this provision. (55) The marketable risk countries are the United Kingdom, the Member States of the Union, Australia, Canada, Iceland, Japan, New Zealand, Norway, Switzerland, and the United States of America. (56) For greater certainty, this is without prejudice to Article 364(1) and (2). (57) For greater certainty, the law of the United Kingdom for the purposes of this Article does not include any law [i] having effect by virtue of section 2(1) of the European Communities Act 1972, as saved by section 1A of the European Union (Withdrawal) Act 2018, or [ii] passed or made under, or for a purpose specified in, section 2(2) of the European Communities Act 1972. (58) For the United Kingdom, this Article requires a new remedy of recovery which would be available at the end of a successful judicial review, in accordance with the standard of review under national law, commenced within the specified time period; such review is not expanded in any other way, in accordance with Article 372(3). No beneficiary would be able to raise a legitimate expectation to resist such recovery. (59) The Parties note that the United Kingdom will implement a new system of subsidy control subsequent to the entry into force of this Agreement. (60) National maritime cabotage covers: for the Union, without prejudice to the scope of activities which may be considered as cabotage under the relevant national legislation, transportation of passengers or goods between a port or point located in a Member State of the Union and another port or point located in that same Member State of the Union, including on its continental shelf, as provided for in the United Nations Convention on the Law of the Sea, and traffic originating and terminating in the same port or point located in a Member State of the Union; for the United Kingdom, transportation of passengers or goods between a port or point located in the United Kingdom and another port or point located in the United Kingdom, including on its continental shelf, as provided for in the United Nations Convention on the Law of the Sea, and traffic originating and terminating in the same port or point located in the United Kingdom. (61) For greater certainty, this paragraph shall not apply with respect to the purchase or sale of shares, stock or other forms of equity by a covered entity as a means of its equity participation in another enterprise. (62) For greater certainty, this Chapter and Article 411 do not apply to the Parties' law and standards relating to social security and pensions. (63) Each Party maintains its right to determine its priorities, policies and the allocation of resources in the effective implementation of the ILO Conventions and the relevant provisions of the European Social Charter in a manner consistent with its international commitments, including those under this Title. The Council of Europe, established in 1949, adopted the European Social Charter in 1961, which was revised in 1996. All Member States have ratified the European Social Charter in its original or revised version. For the United Kingdom, the reference to the European Social Charter in paragraph 5 refers to the original 1961 version. (64) For greater certainty, in this case the Party shall not have prior recourse to consultations in accordance with Article 738. (65) Such measures may include withdrawal or adjustment of the rebalancing measures, as appropriate. (66) Suspension of obligations under Article 749 shall be available only if rebalancing measures have in fact been applied. (67) The public security and public order exceptions may be invoked only where a genuine and sufficiently serious threat is posed to one of the fundamental interests of society. (68) For greater certainty, such determination shall be without prejudice to Title I of Part Six. (69) Measures that are aimed at ensuring the equitable or effective imposition or collection of direct taxes include measures taken by a Party under its taxation system which: (i) apply to non-resident service suppliers in recognition of the fact that the tax obligation of non-residents is determined with respect to taxable items sourced or located in the Party's territory; or (ii) apply to non-residents in order to ensure the imposition or collection of taxes in the Party's territory; or (iii) apply to non-residents or residents in order to prevent the avoidance or evasion of taxes, including compliance measures; or (iv) apply to consumers of services supplied in or from the territory of the other Party or of a third country in order to ensure the imposition or collection of taxes on such consumers derived from sources in the Party's territory; or (v) distinguish service suppliers subject to tax on worldwide taxable items from other service suppliers, in recognition of the difference in the nature of the tax base between them; or (vi) determine, allocate or apportion income, profit, gain, loss, deduction or credit of resident persons or branches, or between related persons or branches of the same person, in order to safeguard the Party's tax base. (70) Regulation (EC) No 1073/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international market for coach and bus services, and amending Regulation (EC) No 561/2006 (recast) (OJ EU L 300, 14.11.2009, p. 88). (71) For greater certainty, the term "measure" includes failures to act. (72) This does not include natural persons residing in the territory referred to in Article 774(3). (73) The definition of natural person also includes persons permanently residing in the Republic of Latvia who are not citizens of the Republic of Latvia or any other state but who are entitled, under the law of the Republic of Latvia, to receive a non-citizen's passport. (74) For greater certainty, the "GPA" shall be understood to be the GPA as amended by the Protocol Amending the Agreement on Government Procurement, done at Geneva on 30 March 2012. (75) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (recast) (OJ EU L 269, 10.10.2013, p. 1). (76) For greater certainty, for the Union, the areas beyond each Party's territorial sea shall be understood as the respective areas of the Member States of the Union. (77) Council Decision 2008/615/JHA of 23 June 2008 on the stepping up of cross-border cooperation, particularly in combating terrorism and cross-border crime (OJ EU L 210, 6.8.2008, p. 1). (78) Council Decision 2008/616/JHA of 23 June 2008 on the implementation of Decision 2008/615/JHA on the stepping up of cross-border cooperation, particularly in combating terrorism and cross-border crime (OJ EU L 210, 6.8.2008, p. 12). (79) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ EU L 135, 24.5.2016, p. 53). (80) Regulation (EU) 2018/1727 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA (OJ EU L 295, 21.11.2018, p. 138). (81) Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States (OJ EU L 190, 18.7.2002, p. 1). (82) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ EU L 119, 4.5.2016, p. 89). (83) 2018 chapter 12. (84) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance) (OJ EU L 119, 4.5.2016, p. 1). (85) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ EU L 193, 30.7.2018, p. 1). (86) Decision No 541/2014/EU of the European Parliament and of the Council of 16 April 2014 establishing a Framework for Space Surveillance and Tracking Support (OJ EU L 158, 27.5.2014, p. 227). (87) For greater certainty, paragraphs 2 to 9 apply in respect of negotiations between the Union and a third country for accession to the Union taking place after the entry into force of this Agreement, notwithstanding the fact a request for accession took place before the entry into force of this Agreement. (88) As amended by the Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2020 (SI 2020/1586). ANNEX 1 RULES OF PROCEDURE OF THE PARTNERSHIP COUNCIL AND COMMITTEES Rule 1 Chair 1. The Union and the United Kingdom shall notify each other of the name, position and contact details of their respective designated co-chairs. A co-chair is deemed to have the authorisation for representing, respectively, the Union or the United Kingdom until the date a new co-chair has been notified to the other Party. 2. The decisions of the co-chairs provided for by these Rules of Procedure shall be taken by mutual consent. 3. A co-chair may be replaced for a particular meeting by a designee. The co-chair, or his or her designee, shall notify the other co-chair and the Secretariat of the Partnership Council of the designation as early as possible. Any reference in these Rules of Procedure to the co-chairs shall be understood to include a designee. Rule 2 Secretariat The Secretariat of the Partnership Council (the "Secretariat") shall be composed of an official of the Union and an official of the Government of the United Kingdom. The Secretariat shall perform the tasks conferred on it by these Rules of Procedure. The Union and the United Kingdom shall notify each other of the name, position and contact details of the official who is the member of the Secretariat of the Partnership Council for the Union and the United Kingdom, respectively. This official is deemed to continue acting as member of the Secretariat for the Union or for the United Kingdom until the date either the Union or the United Kingdom has notified a new member. Rule 3 Meetings 1. Each meeting of the Partnership Council shall be convened by the Secretariat at a date and time agreed by the co-chairs. Where the Union or the United Kingdom has transmitted a request for a meeting through the Secretariat, the Partnership Council shall endeavour to meet within 30 days of such request, or sooner in cases provided for in this Agreement. 2. The Partnership Council shall hold its meetings alternately in Brussels and London, unless the co-chairs decide otherwise. 3. By way of derogation from paragraph 2, the co-chairs may agree that a meeting of the Partnership Council be held by videoconference or teleconference. Rule 4 Participation in meetings 1. A reasonable period of time in advance of each meeting, the Union and the United Kingdom shall inform each other through the Secretariat of the intended composition of their respective delegations and shall specify the name and function of each member of the delegation. 2. Where appropriate the co-chairs may, by mutual consent, invite experts (i.e. non-government officials) to attend meetings of the Partnership Council in order to provide information on a specific subject and only for the parts of the meeting where such specific subjects are discussed. Rule 5 Documents Written documents on which the deliberations of the Partnership Council are based shall be numbered and circulated to the Union and the United Kingdom by the Secretariat. Rule 6 Correspondence 1. The Union and the United Kingdom shall send their correspondence addressed to the Partnership Council via the Secretariat. Such correspondence may be sent in any form of written communication, including by electronic mail. 2. The Secretariat shall ensure that correspondence addressed to the Partnership Council is delivered to the co-chairs and is circulated, where appropriate, in accordance with Rule 5. 3. All correspondence from, or addressed directly to, the co-chairs shall be forwarded to the Secretariat and shall be circulated, where appropriate, in accordance with Rule 5. Rule 7 Agenda for the meetings 1. For each meeting, a draft provisional agenda shall be drawn up by the Secretariat. It shall be transmitted, together with the relevant documents, to the co-chairs no later than 10 days before the date of the meeting. 2. The provisional agenda shall include items requested by the Union or the United Kingdom. Any such request, together with any relevant document, shall be submitted to the Secretariat no later than 15 days before the beginning of the meeting. 3. No later than 5 days before the date of the meeting, the co-chairs shall decide on the provisional agenda for a meeting. 4. The agenda shall be adopted by the Partnership Council at the beginning of each meeting. On request by the Union or the United Kingdom, an item other than those included in the provisional agenda may be included in the agenda by consensus. 5. The co-chairs may, by mutual consent, reduce or increase the time periods specified in paragraphs 1, 2 and 3 in order to take account of the requirements of a particular case. Rule 8 Minutes 1. Draft minutes of each meeting shall be drawn up by the official acting as member of the Secretariat of the Party hosting the meeting, within 15 days from the end of the meeting, unless otherwise decided by the co-chairs. The draft minutes shall be transmitted for comments to the member of the Secretariat of the other Party. The latter may submit comments within 7 days from the date of receipt of the draft minutes. 2. The minutes shall, as a rule, summarise each item on the agenda, specifying where applicable: (a) the documents submitted to the Partnership Council; (b) any statement that one of the co-chairs requested to be entered in the minutes; and (c) the decisions taken, recommendations made, statements agreed upon and conclusions adopted on specific items. 3. The minutes shall include as an annex a list of participants setting out for each of the delegations the names and functions of all individuals who attended the meeting. 4. The Secretariat shall adjust the draft minutes on the basis of comments received and the draft minutes, as revised, shall be approved by the co-chairs within 28 days of the date of the meeting, or by any other date agreed by the co-chairs. Once approved, two versions of the minutes shall be authenticated by signature of the members of the Secretariat. The Union and the United Kingdom shall each receive one of these authentic versions. The co-chairs may agree that signing and exchanging electronic copies satisfies this requirement. Rule 9 Decisions and Recommendations 1. In the period between meetings, the Partnership Council may adopt decisions or recommendations by written procedure. The text of a draft decision or recommendation shall be presented in writing by a co-chair to the other co-chair in the working language of the Partnership Council. The other Party shall have one month, or any longer period of time specified by the proposing Party, to express its agreement to the draft decision or recommendation. If the other Party does not express its agreement, the proposed decision or recommendation shall be discussed and may be adopted at the next meeting of the Partnership Council. The draft decisions or recommendations shall be deemed to be adopted once the other Party expresses its agreement and shall be recorded in the minutes of the next meeting of the Partnership Council pursuant to Rule 8. 2. Where the Partnership Council adopts decisions or recommendations, the words "Decision" or "Recommendation", respectively, shall be inserted in the title of such acts. The Secretariat shall record any decision or recommendation under a serial number and with a reference to the date of its adoption. 3. Decisions adopted by the Partnership Council shall specify the date on which they take effect. 4. Decisions and recommendations adopted by the Partnership Council shall be established in duplicate in the authentic languages and signed by the co-chairs and shall be sent by the Secretariat to the Union and the United Kingdom immediately after signature. The co-chairs may agree that signing and exchanging electronic copies satisfies the requirement for signature. Rule 10 Transparency 1. The co-chairs may agree that the Partnership Council shall meet in public. 2. Each Party may decide on the publication of the decisions and recommendations of the Partnership Council in its respective official journal or online. 3. If the Union or the United Kingdom submits information that is confidential or protected from disclosure under its laws and regulations to the Partnership Council, the other party shall treat that information received as confidential. 4. Provisional agendas of the meetings shall be made public before the meeting of the Partnership Council takes place. The minutes of the meetings shall be made public following their approval in accordance with Rule 8. 5. Publication of documents referred to in paragraphs 2, 3 and 4 shall be made in compliance with both Parties’ applicable data protection rules. Rule 11 Languages 1. The official languages of the Partnership Council shall be the official languages of the Union and the United Kingdom. 2. The working language of the Partnership Council shall be English. Unless otherwise decided by the co-chairs, the Partnership Council shall base its deliberations on documents prepared in English. 3. The Partnership Council shall adopt decisions concerning the amendment or interpretation of this Agreement in the languages of the authentic texts of this Agreement. All other decisions of the Partnership Council, including the ones through which the present rules of procedure are amended, shall be adopted in the working language referred to in paragraph 2. Rule 12 Expenses 1. The Union and the United Kingdom shall each meet any expenses they incur as a result of participating in the meetings of the Partnership Council. 2. Expenditure in connection with the organisation of meetings and reproduction of documents shall be borne by the party hosting the meeting. 3. Expenditure in connection with interpretation to and from the working language of the Partnership Council at meetings shall be borne by the party requesting such interpretation. 4. Each Party shall be responsible for the translation of decisions and other documents into its own official language(s), if required pursuant to Rule 11, and it shall meet expenditures associated with such translations. Rule 13 Committees 1. Without prejudice to paragraph 2 of this Rule, Rules 1 to 12 shall apply mutatis mutandis to the Committees. 2. The Committees shall inform the Partnership Council of their meeting schedules and agenda sufficiently in advance of their meetings, and shall report to the Partnership Council on the results and conclusions of each of their meetings. ANNEX 2 INTRODUCTORY NOTES TO PRODUCT-SPECIFIC RULES OF ORIGIN NOTE 1 General principles 1. This Annex sets out the general rules for the applicable requirements of Annex 3 as provided for in point (c) of Article 39(1) of this Agreement. 2. For the purposes of this Annex and Annex 3, the requirements for a product to be originating in accordance with point (c) of Article 39(1) of this Agreement are a change in tariff classification, a production process, a maximum value or weight of non-originating materials, or any other requirement specified in this Annex and Annex 3. 3. Reference to weight in a product-specific rule of origin means the net weight, which is the weight of a material or a product, not including the weight of any packaging. 4. This Annex and Annex 3 are based on the Harmonised System, as amended on 1 January 2017. NOTE 2 The structure of the list of product-specific rules of origin 1. Notes on sections or Chapters, where applicable, are read in conjunction with the product-specific rules of origin for the relevant section, Chapter, heading or subheading. 2. Each product-specific rule of origin set out in Column 2 of Annex 3 applies to the corresponding product indicated in Column 1 of Annex 3. 3. If a product is subject to alternative product-specific rules of origin, the product shall be originating in a Party if it satisfies one of the alternatives. 4. If a product is subject to a product-specific rule of origin that includes multiple requirements, the product shall be originating in a Party only if it satisfies all of the requirements. 5. For the purposes of this Annex and Annex 3, the following definitions apply: (a) "section" means a section of the Harmonised System; (b) "Chapter" means the first two-digits in the tariff classification number under the Harmonised System; (c) "heading" means the first four-digits in the tariff classification number under the Harmonised System; and (d) "subheading" means the first six-digits in the tariff classification number under the Harmonised System. 6. For the purposes of the product-specific rules of origin, the following abbreviations apply: "CC" means production from non-originating materials of any Chapter, except that of the product; this means that any non-originating material used in the production of the product must be classified under a Chapter (2-digit level of the Harmonised System) other than that of the product (i.e. a change in Chapter); "CTH" means production from non-originating materials of any heading, except that of the product; this means that any non-originating material used in the production of the product must be classified under a heading (4-digit level of the Harmonised System) other than that of the product (i.e. a change in heading); "CTSH" means production from non-originating materials of any subheading, except that of the product; this means that any non-originating material used in the production of the product must be classified under a subheading (6-digit level of the Harmonised System) other than that of the product (i.e. a change in subheading). NOTE 3 Application of the product-specific rules of origin 1. Article 39 of this Agreement, concerning products having acquired originating status which are used in the production of other products, applies whether or not this status has been acquired inside the same factory in a Party where these products are used. 2. If a product-specific rule of origin specifically excludes certain non-originating material or provides that the value or weight of a specified non-originating material shall not exceed a specific threshold, these conditions do not apply to non-originating materials classified elsewhere in the Harmonised System. Example 1: when the rule for bulldozers (subheading 8429.11) requires: "CTH except from non-originating materials of heading 84.31", the use of non-originating materials classified elsewhere than 84.29 and 84.31- such as screws (HS heading 73.18), insulated wires and electric conductors (heading 85.44) and various electronics (Chapter 85) - is not limited. Example 2: When the rule for heading 35.05 (dextrins and other modified starches; glues based on starches etc) requires "CTH except from non-originating materials of heading 11.08" then the use of non-originating materials classified elsewhere than 11.08 (starches, inulin), such as materials of Chapter 10 (cereals), is not limited. 3. If a product-specific rule of origin provides that a product shall be produced from a particular material, this does not prevent the use of other materials which are unable to satisfy that rule because of their inherent nature. NOTE 4 Calculation of a maximum value of non-originating materials For the purposes of the product-specific rules of origin, the following definitions apply: (a) "customs value" means the value as determined in accordance with the Agreement on Implementation of Article VII of GATT 1994; (b) "EXW" or "ex-works price" means: (i) the price of the product paid or payable to the producer in whose undertaking the last working or processing is carried out, provided that the price includes the value of all the materials used and all other costs incurred in the production of the product, minus any internal taxes which are, or may be, repaid when the product obtained is exported; or (ii) if there is no price paid or payable or if the actual price paid does not reflect all costs related to the production of the product which are actually incurred in the production of the product, the value of all the materials used and all other costs incurred in the production of the product in the exporting Party: (A) including selling, general and administrative expenses, as well as profit, that can reasonably be allocated to the product; and (B) excluding the cost of freight, insurance, all other costs incurred in transporting the product and any internal taxes of the exporting Party which are, or may be, repaid when the product obtained is exported; (iii) for the purposes of point (i), where the last production has been contracted to a producer, the term "producer" in point (i) refers to the person who has employed the subcontractor. (c) "MaxNOM" means the maximum value of non-originating materials expressed as a percentage and shall be calculated according to the following formula: (d) "VNM" means the value of the non-originating materials used in the production of the product which is its customs value at the time of importation including freight, insurance if appropriate, packing and all other costs incurred in transporting the materials to the importation port in the Party where the producer of the product is located; where the value of the non-originating materials is not known and cannot be ascertained, the first ascertainable price paid for the non-originating materials in the Union or in the United Kingdom is used; the value of the non-originating materials used in the production of the product may be calculated on the basis of the weighted average value formula or other inventory valuation method under accounting principles which are generally accepted in the Party. NOTE 5 Definitions of processes referred to in Sections V to VII of Annex 3 For the purposes of product-specific rules of origin, the following definitions apply: (a) "biotechnological processing" means: (i) biological or biotechnological culturing (including cell culture), hybridisation or genetic modification of micro-organisms (bacteria, viruses (including phages) etc.) or human, animal or plant cells; and (ii) production, isolation or purification of cellular or intercellular structures (such as isolated genes, gene fragments and plasmids), or fermentation; (b) "change in particle size" means the deliberate and controlled modification in particle size of a product, other than by merely crushing or pressing, resulting in a product with a defined particle size, defined particle size distribution or defined surface area, which is relevant to the purposes of the resulting product and with physical or chemical characteristics different from those of the input materials; (c) "chemical reaction" means a process (including a biochemical processing) which results in a molecule with a new structure by breaking intramolecular bonds and by forming new intramolecular bonds, or by altering the spatial arrangement of atoms in a molecule, with the exception of the following, which are not considered to be chemical reactions for the purpose of this definition: (i) dissolving in water or other solvents; (ii) the elimination of solvents including solvent water; or (iii) the addition or elimination of water of crystallisation; (d) "distillation" means: (i) atmospheric distillation: a separation process in which petroleum oils are converted, in a distillation tower, into fractions according to boiling point and the vapour then condensed into different liquefied fractions; products produced from petroleum distillation may include liquefied petroleum gas, naphtha, gasoline, kerosene, diesel or heating oil, light gas oils and lubricating oil; and (ii) vacuum distillation: distillation at a pressure below atmospheric but not so low that it would be classed as molecular distillation; vacuum distillation is used for distilling high-boiling and heat-sensitive materials such as heavy distillates in petroleum oils to produce light to heavy vacuum gas oils and residuum; (e) "isomer separation" means the isolation or separation of isomers from a mixture of isomers; (f) "mixing and blending" means the deliberate and proportionally controlled mixing or blending (including dispersing) of materials, other than the addition of diluents, only to conform to predetermined specifications which results in the production of a product having physical or chemical characteristics that are relevant to the purposes or uses of the product and are different from the input materials; (g) "production of standard materials" (including standard solutions) means a production of a preparation suitable for analytical, calibrating or referencing uses with precise degrees of purity or proportions certified by the producer; and (h) "purification" means a process which results in the elimination of at least 80 % of the content of existing impurities or the reduction or elimination of impurities resulting in a good suitable for one or more of the following applications: (i) pharmaceutical, medical, cosmetic, veterinary or food grade substances; (ii) chemical products and reagents for analytical, diagnostic or laboratory uses; (iii) elements and components for use in micro-electronics; (iv) specialised optical uses; (v) biotechnical use, for example, in cell culturing, in genetic technology or as a catalyst; (vi) carriers used in a separation process; or (vii) nuclear grade uses. NOTE 6 Definitions of terms used in Section XI of Annex 3 For the purposes of the product-specific rules of origin, the following definitions apply: (a) "man-made staple fibres" means synthetic or artificial filament tow, staple fibres or waste, of headings 55.01 to 55.07; (b) "natural fibres" means fibres other than synthetic or artificial fibres, the use of which is restricted to the stages before spinning takes place, including waste, and, unless otherwise specified, includes fibres which have been carded, combed or otherwise processed, but not spun; "natural fibres" includes horsehair of heading 05.11, silk of headings 50.02 and 50.03, wool-fibres and fine or coarse animal hair of headings 51.01 to 51.05, cotton fibres of headings 52.01 to 52.03, and other vegetable fibres of headings 53.01 to 53.05; (c) "printing" means a technique by which an objectively assessed function, such as colour, design, or technical performance, is given to a textile substrate with a permanent character, using screen, roller, digital or transfer techniques; and (d) "printing (as standalone operation)" means a technique by which an objectively assessed function, such as colour, design, or technical performance, is given to a textile substrate with a permanent character, using screen, roller, digital or transfer techniques combined with at least two preparatory or finishing operations (such as scouring, bleaching, mercerizing, heat setting, raising, calendaring, shrink resistance processing, permanent finishing, decatising, impregnating, mending and burling, shearing, singeing, process of air-tumbler, process of stenter, milling, steam and shrinking, and wet decatising), provided that the value of all the non-originating materials used does not exceed 50 % of the EXW of the product. NOTE 7 Tolerances applicable to products containing two or more basic textile materials 1. For the purposes of this Note, basic textile materials are the following: (a) silk; (b) wool; (c) coarse animal hair; (d) fine animal hair; (e) horsehair; (f) cotton; (g) paper-making materials and paper; (h) flax; (i) true hemp; (j) jute and other textile bast fibres; (k) sisal and other textile fibres of the genus Agave; (l) coconut, abaca, ramie and other vegetable textile fibres; (m) synthetic man-made filaments; (n) artificial man-made filaments; (o) current-conducting filaments; (p) synthetic man-made staple fibres of polypropylene; (q) synthetic man-made staple fibres of polyester; (r) synthetic man-made staple fibres of polyamide; (s) synthetic man-made staple fibres of polyacrylonitrile; (t) synthetic man-made staple fibres of polyimide; (u) synthetic man-made staple fibres of polytetrafluoroethylene; (v) synthetic man-made staple fibres of poly (phenylene sulphide); (w) synthetic man-made staple fibres of poly (vinyl chloride); (x) other synthetic man-made staple fibres; (y) artificial man-made staple fibres of viscose; (z) other artificial man-made staple fibres; (aa) yarn made of polyurethane segmented with flexible segments of polyether, whether or not gimped; (bb) yarn made of polyurethane segmented with flexible segments of polyester whether or not gimped; (cc) products of heading 56.05 (metallised yarn) incorporating strip consisting of a core of aluminium foil or of a core of plastic film irrespective of whether or not coated with aluminium powder, of a width not exceeding 5 mm, sandwiched by means of a transparent or coloured adhesive between two layers of plastic film; (dd) other products of heading 56.05; (ee) glass fibres; and (ff) metal fibres. 2. Where reference to this Note is made in Annex 3, the requirements set out in its Column 2 shall not apply, as a tolerance, to non-originating basic textile materials which are used in the production of a product, provided that: (a) the product contains two or more basic textile materials; and (b) the weight of the non-originating basic textile materials, taken together, does not exceed 10 % of the total weight of all the basic textile materials used. Example: For a woollen fabric of heading 51.12 containing woollen yarn of heading 51.07, synthetic yarn of staple fibres of heading 55.09 and materials other than basic textile materials, non-originating woollen yarn which does not satisfy the requirement set out in Annex 3, or non-originating synthetic yarn which does not satisfy the requirement set out in Annex 3, or a combination of both, may be used, provided that their total weight does not exceed 10 % of the weight of all the basic textile materials. 3. Notwithstanding point (b) of paragraph 2, for products containing "yarn made of polyurethane segmented with flexible segments of polyether, whether or not gimped", the maximum tolerance is 20 %. However, the percentage of the other non-originating basic textile materials shall not exceed 10 %. 4. Notwithstanding point (b) of paragraph 2, for products containing "strip consisting of a core of aluminium foil or of a core of plastic film irrespective of whether or not coated with aluminium powder, of a width not exceeding 5 mm, sandwiched by means of a transparent or coloured adhesive between two layers of plastic film", the maximum tolerance is 30 %. However, the percentage of the other non-originating basic textile materials shall not exceed 10 %. NOTE 8 Other tolerances applicable to certain textile products 1. Where reference to this Note is made in Annex 3, non-originating textile materials (with the exception of linings and interlinings) which do not satisfy the requirements set out in its Column 2 for a made-up textile product may be used, provided that they are classified under a heading other than that of the product and that their value does not exceed 8 % of the EXW of the product. 2. Non-originating materials which are not classified under Chapters 50 to 63 may be used without restriction in the production of textile products classified under Chapters 50 to 63, whether or not they contain textiles. Example: If a requirement set out in Annex 3 provides that yarn shall be used, for a certain textile item (such as trousers), this does not prevent the use of non-originating metal items (such as buttons), because metal items are not classified under Chapters 50 to 63. For the same reasons, it does not prevent the use of non-originating slide fasteners, even though slide-fasteners normally contain textiles. 3. Where a requirement set out in Annex 3 consists in a maximum value of non-originating materials, the value of the non-originating materials which are not classified under Chapters 50 to 63 shall be taken into account in the calculation of the value of the non-originating materials. NOTE 9 Agricultural products Agricultural products classified under Section II of the Harmonised System and heading 24.01, which are grown or harvested in the territory of a Party, shall be treated as originating in the territory of that Party, even if grown from seeds, bulbs, rootstock, cuttings, slips, grafts, shoots, buds, or other live parts of plants imported from a third country. ANNEX 3 PRODUCT-SPECIFIC RULES OF ORIGIN Column 1 Harmonised System classification (2017) including specific description Column 2 Product-specific rule of origin SECTION I LIVE ANIMALS; ANIMAL PRODUCTS Chapter 1 Live animals 01.01-01.06 All animals of Chapter 1 are wholly obtained. Chapter 2 Meat and edible meat offal 02.01-02.10 Production in which all the materials of Chapters 1 and 2 used are wholly obtained. Chapter 3 Fish and crustaceans, molluscs and other aquatic invertebrates 03.01-03.08 Production in which all the materials of Chapter 3 used are wholly obtained. Chapter 4 Dairy produce; birds' eggs; natural honey; edible products of animal origin, not elsewhere specified or included 04.01-04.10 Production in which: — all the materials of Chapter 4 used are wholly obtained; and — the total weight of non-originating materials of headings 17.01 and 17.02 does not exceed 20 % of the weight of the product. Chapter 5 Products of animal origin, not elsewhere specified or included 05.01-05.11 Production from non-originating materials of any heading. SECTION II VEGETABLE PRODUCTS Chapter 6 Live trees and other plants; bulbs, roots and the like; cut flowers and ornamental foliage 06.01-06.04 Production in which all the materials of Chapter 6 used are wholly obtained. Chapter 7 Edible vegetables and certain roots and tubers 07.01-07.14 Production in which all the materials of Chapter 7 used are wholly obtained. Chapter 8 Edible fruit and nuts; peel of citrus fruit or melons 08.01-08.14 Production in which: — all the materials of Chapter 8 used are wholly obtained; and — the total weight of non-originating materials of headings 17.01 and 17.02 does not exceed 20 % of the weight of the product. Chapter 9 Coffee, tea, maté and spices 09.01-09.10 Production from non-originating materials of any heading. Chapter 10 Cereals 10.01-10.08 Production in which all the materials of Chapter 10 used are wholly obtained. Chapter 11 Products of the milling industry; malt; starches; inulin; wheat gluten 11.01-11.09 Production in which all materials of Chapters 10 and 11, headings 07.01, 07.14, 23.02 to 23.03 or subheading 0710.10 used are wholly obtained. Chapter 12 Oil seeds and oleaginous fruits; miscellaneous grains, seeds and fruit; industrial or medicinal plants; straw and fodder 12.01-12.14 CTH Chapter 13 Lac; gums, resins and other vegetable saps and extracts 13.01-13.02 Production from non-originating materials of any heading in which the total weight of non-originating materials of headings 17.01 and 17.02 does not exceed 20 % of the weight of the product. Chapter 14 Vegetable plaiting materials; vegetable products not elsewhere specified or included 14.01-14.04 Production from non-originating materials of any heading. SECTION III ANIMAL OR VEGETABLE FATS AND OILS AND THEIR CLEAVAGE PRODUCTS; PREPARED EDIBLE FATS; ANIMAL OR VEGETABLE WAXES Chapter 15 Animal or vegetable fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes 15.01-15.04 CTH 15.05-15.06 Production from non-originating materials of any heading. 15.07-15.08 CTSH 15.09-15.10 Production in which all the vegetable materials used are wholly obtained. 15.11-15.15 CTSH 15.16-15.17 CTH 15.18-15.19 CTSH 15.20 Production from non-originating materials of any heading. 15.21-15.22 CTSH SECTION IV PREPARED FOODSTUFFS; BEVERAGES, SPIRITS AND VINEGAR; TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES Chapter 16 Preparations of meat, of fish or of crustaceans, molluscs or other aquatic invertebrates 1601.00-1604.18 Production in which all the materials of Chapters 1, 2, 3 and 16 used are wholly obtained (1). 1604.19 CC 1604.20 — Preparations of surimi: CC — Others: Production in which all the materials of Chapters 3 and 16 used are wholly obtained (2). 1604.31-1605.69 Production in which all the materials of Chapters 3 and 16 used are wholly obtained. Chapter 17 Sugars and sugar confectionery 17.01 CTH 17.02 CTH, provided that the total weight of non-originating materials of headings 11.01 to 11.08, 17.01 and 17.03 used does not exceed 20 % of the weight of the product. 17.03 CTH 17.04 — White chocolate: CTH, provided that: (a) all the materials of Chapter 4 used are wholly obtained; and (b) (i) the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 40 % of the weight of the product; or (ii) the value of non-originating materials of headings 17.01 and 17.02 used does not exceed 30 % of the ex-works price of the product. — Others: CTH, provided that: — all the materials of Chapter 4 used are wholly obtained; and — the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 40 % of the weight of the product. Chapter 18 Cocoa and cocoa preparations 18.01-18.05 CTH 1806.10 CTH, provided that: — all the materials of Chapter 4 used are wholly obtained; and — the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 40 % of the weight of the product. 1806.20-1806.90 CTH, provided that: (a) all the materials of Chapter 4 used are wholly obtained; and (b) (i) the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 40 % of the weight of the product; or (ii) the value of non-originating materials of headings 17.01 and 17.02 used does not exceed 30 % of the ex-works price of the product. Chapter 19 Preparations of cereals, flour, starch or milk; pastrycooks' products 19.01-19.05 CTH, provided that: — all the materials of Chapter 4 used are wholly obtained; — the total weight of non-originating materials of Chapters 2, 3 and 16 used does not exceed 20 % of the weight of the product; — the total weight of non-originating materials of headings 10.06 and 11.08 used does not exceed 20 % of the weight of the product; and — the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 40 % of the weight of the product. Chapter 20 Preparations of vegetables, fruit, nuts or other parts of plants 20.01 CTH 20.02-20.03 Production in which all the materials of Chapter 7 used are wholly obtained. 20.04-20.09 CTH, provided that the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 40 % of the weight of the product. Chapter 21 Miscellaneous edible preparations 21.01-21.02 CTH, provided that: — all the materials of Chapter 4 used are wholly obtained; and — the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 20 % of the weight of the product. 2103.10 2103.20 2103.90 CTH; however, non-originating mustard flour or meal or prepared mustard may be used. 2103.30 Production from non-originating materials of any heading. 21.04-21.06 CTH, provided that: — all the materials of Chapter 4 used are wholly obtained; and — the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 20 % of the weight of the product. Chapter 22 Beverages, spirits and vinegar 22.01-22.06 CTH except from non-originating materials of headings 22.07 and 22.08, provided that: — all the materials of subheadings 0806.10, 2009.61, 2009.69 used are wholly obtained; — all the materials of Chapter 4 used are wholly obtained; and — the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 20 % of the weight of the product. 22.07 CTH except from non-originating materials of heading 22.08, provided that all the materials of Chapter 10, subheadings 0806.10, 2009.61 and 2009.69 used are wholly obtained. 22.08-22.09 CTH except from non-originating materials of headings 22.07 and 22.08, provided that all the materials of subheadings 0806.10, 2009.61 and 2009.69 used are wholly obtained. Chapter 23 Residues and waste from the food industries; prepared animal fodder 23.01 CTH 2302.10-2303.10 CTH, provided that the total weight of non-originating materials of Chapter 10 used does not exceed 20 % of the weight of the product. 2303.20-2308.00 CTH 23.09 CTH, provided that: — all the materials of Chapters 2 and 4 used are wholly obtained; — the total weight of non-originating materials of headings 10.01 to 10.04, 10.07 to 10.08, Chapter 11, and headings 23.02 and 23.03 used does not exceed 20 % of the weight of the product; and — the total weight of non-originating materials of headings 17.01 and 17.02 used does not exceed 20 % of the weight of the product. Chapter 24 Tobacco and manufactured tobacco substitutes 24.01 Production in which all materials of heading 24.01 are wholly obtained. 2402.10 Production from non-originating materials of any heading, provided that the total weight of non-originating materials of heading 24.01 used does not exceed 30 % of the weight of materials of Chapter 24 used. 2402.20 Production from non-originating materials of any heading, except that of the product and of smoking tobacco of subheading 2403.19, and in which at least 10 % by weight of all materials of heading 24.01 used is wholly obtained. 2402.90 Production from non-originating materials of any heading, provided that the total weight of non-originating materials of heading 24.01 used does not exceed 30 % of the weight of materials of Chapter 24 used. 24.03 CTH, in which at least 10 % by weight of all materials of heading 24.01 used are wholly obtained. SECTION V MINERAL PRODUCTS Section note: For definitions of horizontal processing rules within this Section, see Note 5 of Annex 2 Chapter 25 Salt; sulphur; earths and stone; plastering materials, lime and cement 25.01-25.30 CTH; or MaxNOM 70 % (EXW). Chapter 26 Ores, slag and ash 26.01-26.21 CTH Chapter 27 Mineral fuels, mineral oils and products of their distillation; bituminous substances; mineral waxes 27.01-27.09 Production from non-originating materials of any heading. 27.10 CTH except from non-originating biodiesel of subheading 3824.99 or 3826.00; or Distillation or a chemical reaction is undergone, provided that biodiesel (including hydrotreated vegetable oil) of heading 27.10 and subheadings 3824.99 and 3826.00 used is obtained by esterification, transesterification or hydrotreatment. 27.11-27.15 Production from non-originating materials of any heading. SECTION VI PRODUCTS OF THE CHEMICAL OR ALLIED INDUSTRIES Section note: For definitions of horizontal processing rules within this Section, see Note 5 of Annex 2 Chapter 28 Inorganic chemicals; organic or inorganic compounds of precious metals, of rare-earth metals, of radioactive elements or of isotopes 28.01-28.53 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 29 Organic chemicals 2901.10-2905.42 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 2905.43-2905.44 CTH except from non-originating materials of heading 17.02 and subheading 3824.60. 2905.45 CTSH, however, non-originating materials of the same subheading as the product may be used, provided that their total value does not exceed 20 % of the ex-works price of the product; or MaxNOM 50 % (EXW). 2905.49-2942 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 30 Pharmaceutical products 30.01-30.06 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 31 Fertilisers 31.01-31.04 CTH, however, non-originating materials of the same heading as the product may be used, provided that their total value does not exceed 20 % of the EXW of the product; or MaxNOM 40 % (EXW). 31.05 — Sodium nitrate — Calcium cyanamide — Potassium sulphate — Magnesium potassium sulphate CTH, however, non-originating materials of the same heading as the product may be used, provided that their total value does not exceed 20 % of the EXW of the product; or MaxNOM 40 % (EXW). -Others CTH, however, non-originating materials of the same heading as the product may be used, provided that their total value does not exceed 20 % of the EXW of the product, and in which the value of all non-originating materials used does not exceed 50 % of the EXW of the product; or MaxNOM 40 % (EXW). Chapter 32 Tanning or dyeing extracts; tannins and their derivatives; dyes, pigments and other colouring matter; paints and varnishes; putty and other mastics; inks 32.01-32.15 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 33 Essential oils and resinoids; perfumery, cosmetic or toilet preparations 33.01 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 3302.10 CTH, however, non-originating materials of subheading 3302.10 may be used, provided that their total value does not exceed 20 % of the EXW of the product. 3302.90 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 33.03 Production from non-originating materials of any heading. 33.04 -33.07 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 34 Soap, organic surface-active agents, washing preparations, lubricating preparations, artificial waxes, prepared waxes, polishing or scouring preparations, candles and similar articles, modelling pastes, "dental waxes" and dental preparations with a basis of plaster 34.01-34.07 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 35 Albuminoidal substances; modified starches; glues; enzymes 35.01-35.04 CTH except from non-originating materials of Chapter 4. 35.05 CTH except from non-originating materials of heading 11.08. 35.06-35.07 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 36 Explosives; pyrotechnic products; matches; pyrophoric alloys; certain combustible preparations 36.01-36.06 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 37 Photographic or cinematographic goods 37.01-37.07 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). Chapter 38 Miscellaneous chemical products 38.01-38.08 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 3809.10 CTH except from non-originating materials of headings 11.08 and 35.05. 3809.91-3822.00 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 38.23 Production from non-originating material of any heading. 3824.10-3824.50 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 3824.60 CTH except from non-originating materials of subheadings 2905.43 and 2905.44. 3824.71-3825.90 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 38.26 Production in which biodiesel is obtained through transesterification, esterification or hydro-treatment. SECTION VII PLASTICS AND ARTICLES THEREOF; RUBBER AND ARTICLES THEREOF Section note: For definitions of horizontal processing rules within this Section, see Note 5 of Annex 2 Chapter 39 Plastics and articles thereof 39.01-39.15 CTSH; A chemical reaction, purification, mixing and blending, production of standard materials, a change in particle size, isomer separation, or biotechnological processing is undergone; or MaxNOM 50 % (EXW). 39.16-39.19 CTH; or MaxNOM 50 % (EXW). 39.20 CTSH; or MaxNOM 50 % (EXW). 39.21-39.22 CTH; or MaxNOM 50 % (EXW). 3923.10-3923.50 CTSH; or MaxNOM 50 % (EXW). 3923.90-3925.90 CTH; or MaxNOM 50 % (EXW). 39.26 CTSH; or MaxNOM 50 % (EXW). Chapter 40 Rubber and articles thereof 40.01-40.11 CTH; or MaxNOM 50 % (EXW). 4012.11-4012.19 CTSH; or Retreading of used tyres. 4012.20-4017.00 CTH; or MaxNOM 50 % (EXW). SECTION VIII RAW HIDES AND SKINS, LEATHER, FURSKINS AND ARTICLES THEREOF; SADDLERY AND HARNESS; TRAVEL GOODS, HANDBAGS AND SIMILAR CONTAINERS; ARTICLE OF ANIMAL GUT (OTHER THAN SILK-WORM GUT) Chapter 41 Raw hides and skins (other than furskins) and leather 41.01-4104.19 CTH 4104.41-4104.49 CTSH except from non-originating materials of subheadings 4104.41 to 4104.49. 4105.10 CTH 4105.30 CTSH 4106.21 CTH 4106.22 CTSH 4106.31 CTH 4106.32-4106.40 CTSH 4106.91 CTH 4106.92 CTSH 41.07-41.13 CTH except from non-originating materials of subheadings 4104.41, 4104.49, 4105.30, 4106.22, 4106.32 and 4106.92. However, non-originating materials of subheadings 4104.41, 4104.49, 4105.30, 4106.22, 4106.32 or 4106.92 may be used provided that they undergo a retanning operation. 4114.10 CTH 4114.20 CTH except from non-originating materials of subheadings 4104.41, 4104.49, 4105.30, 4106.22, 4106.32, 4106.92 and 4107. However, non-originating materials of subheadings 4104.41, 4104.49, 4105.30, 4106.22, 4106.32, 4106.92 and heading 41.07 may be used provided that they undergo a retanning operation. 41.15 CTH Chapter 42 Articles of leather; saddlery and harness; travel goods, handbags and similar containers; articles of animal gut (other than silk-worm gut) 42.01-42.06 CTH; or MaxNOM 50 % (EXW). Chapter 43 Furskins and artificial fur; manufactures thereof 4301.10-4302.20 CTH; or MaxNOM 50 % (EXW). 4302.30 CTSH 43.03-43.04 CTH; or MaxNOM 50 % (EXW). SECTION IX WOOD AND ARTICLES OF WOOD; WOOD CHARCOAL; CORK AND ARTICLES OF CORK; MANUFACTURES OF STRAW, OF ESPARTO OR OTHER PLAITING MATERIALS; BASKETWARE AND WICKERWORK Chapter 44 Wood and articles of wood; wood charcoal 44.01-44.21 CTH; or MaxNOM 50 % (EXW). Chapter 45 Cork and articles of cork 45.01-45.04 CTH; or MaxNOM 50 % (EXW). Chapter 46 Manufactures of straw, of esparto or of other plaiting materials; basketware and wickerwork 46.01-46.02 CTH; or MaxNOM 50 % (EXW). SECTION X PULP OF WOOD OR OF OTHER FIBROUS CELLULOSIC MATERIAL; RECOVERED (WASTE AND SCRAP) PAPAER OR PAPERBOARD; PAPER AND PAPERBOARD AND ARTICLES THEREOF Chapter 47 Pulp of wood or of other fibrous cellulosic material; recovered (waste and scrap) paper or paperboard 47.01-47.07 CTH; or MaxNOM 50 % (EXW). Chapter 48 Paper and paperboard; articles of paper pulp, of paper or of paperboard 48.01-48.23 CTH; or MaxNOM 50 % (EXW). Chapter 49 Printed books, newspapers, pictures and other products of the printing industry; manuscripts, typescripts and plans 49.01-49.11 CTH; or MaxNOM 50 % (EXW). SECTION XI TEXTILES AND TEXTILE ARTICLES Section note: For definitions of terms used for tolerances applicable to certain products made of textile materials, see Notes 6,7 and 8 of Annex 2 Chapter 50 Silk 50.01-50.02 CTH 50.03 — Carded or combed: Carding or combing of silk waste. — Others: CTH 50.04-50.05 Spinning of natural fibres; Extrusion of man-made continuous filament combined with spinning; Extrusion of man-made continuous filament combined with twisting; or Twisting combined with any mechanical operation. 50.06 — Silk yarn and yarn spun from silk waste: Spinning of natural fibres; Extrusion of man-made continuous filament combined with spinning; Extrusion of man-made continuous filament combined with twisting; or Twisting combined with any mechanical operation. — Silk-worm gut: CTH 50.07 Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Twisting or any mechanical operation combined with weaving; Weaving combined with dyeing; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 51 Wool, fine or coarse animal hair; horsehair yarn and woven fabric 51.01-51.05 CTH 51.06-51.10 Spinning of natural fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 51.11-51.13 Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Weaving combined with dyeing; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 52 Cotton 52.01-52.03 CTH 52.04-52.07 Spinning of natural fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 52.08-52.12 Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Twisting or any mechanical operation combined with weaving; Weaving combined with dyeing or with coating or with laminating; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 53 Other vegetable textile fibres; paper yarn and woven fabrics of paper yarn 53.01-53.05 CTH 53.06-53.08 Spinning of natural fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 53.09-53.11 Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Weaving combined with dyeing or with coating or with laminating; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 54 Man-made filaments; strip and the like of man-made textile materials 54.01-54.06 Spinning of natural fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 54.07-54.08 Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Yarn dyeing combined with weaving; Weaving combined with dyeing or with coating or with laminating; Twisting or any mechanical operation combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 55 Man-made staple fibres 55.01-55.07 Extrusion of man-made fibres. 55.08-55.11 Spinning of natural fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 55.12-55.16 Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Twisting or any mechanical operation combined with weaving; Weaving combined with dyeing or with coating or with laminating; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 56 Wadding, felt and nonwovens; special yarns; twine, cordage, ropes and cables and articles thereof 56.01 Spinning or bonding of natural fibres; Extrusion of man-made fibres combined with spinning or bonding; Flocking combined with dyeing or with printing; or Coating, flocking, laminating, or metalizing combined with at least two other main preparatory or finishing operations (such as calendering, shrink-resistance processes, heat setting, permanent finishing), provided that the value of non-originating materials used does not exceed 50 % of the EXW of the product. 56.02 — Needleloom Felt: Extrusion of man-made fibres combined with fabric formation; however: — non-originating polypropylene filament of heading 54.02; — non-originating polypropylene fibres of heading 55.03 or 55.06; or — non-originating polypropylene filament tow of heading 55.01; of which the denomination in all cases of a single filament or fibre is less than 9 decitex, may be used, provided that their total value does not exceed 40 % of the EXW of the product; or Non-woven fabric formation alone in the case of felt made from natural fibres. — Others: Extrusion of man-made fibres combined with fabric formation; or Non-woven fabric formation alone in the case of other felt made from natural fibres. 5603.11-5603.14 Production from — directionally or randomly oriented filaments; or — substances or polymers of natural or man-made origin; followed in both cases by bonding into a nonwoven. 5603.91-5603.94 Production from — directionally or randomly oriented staple fibres; or — chopped yarns, of natural or man-made origin; followed in both cases by bonding into a nonwoven. 5604.10 Production from rubber thread or cord, not textile covered. 5604.90 Spinning of natural fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 56.05 Spinning of natural or man-made staple fibres; Extrusion of man-made fibres combined with spinning; or Twisting combined with any mechanical operation. 56.06 Extrusion of man-made fibres combined with spinning; Twisting combined with gimping; Spinning of natural or man-made staple fibres; or Flocking combined with dyeing. 56.07-56.09 Spinning of natural fibres; or Extrusion of man-made fibres combined with spinning. Chapter 57 Carpets and other textile floor coverings Chapter note: For products of this Chapter non-originating jute fabric may be used as a backing. 57.01-57.05 Spinning of natural or man-made staple fibres combined with weaving or with tufting; Extrusion of man-made filament yarn combined with weaving or with tufting; Production from coir yarn or sisal yarn or jute yarn or classical ring spun viscose yarn; Tufting combined with dyeing or with printing; Tufting or weaving of man-made filament yarn combined with coating or with laminating; Flocking combined with dyeing or with printing; or Extrusion of man-made fibres combined with nonwoven techniques including needle punching. Chapter 58 Special woven fabrics; tufted textile fabrics; lace; tapestries; trimmings; embroidery 58.01-58.04 Spinning of natural or man-made staple fibres combined with weaving or with tufting; Extrusion of man-made filament yarn combined with weaving or with tufting; Weaving combined with dyeing or with flocking or with coating or with laminating or with metalizing; Tufting combined with dyeing or with printing; Flocking combined with dyeing or with printing; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). 58.05 CTH 58.06-58.09 Spinning of natural or man-made staple fibres combined with weaving or with tufting; Extrusion of man-made filament yarn combined with weaving or with tufting; Weaving combined with dyeing or with flocking or with coating or with laminating or with metalizing; Tufting combined with dyeing or with printing; Flocking combined with dyeing or with printing; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). 58.10 Embroidering in which the value of non-originating materials of any heading, except that of the product, used does not exceed 50 % of the EXW of the product. 58.11 Spinning of natural or man-made staple fibres combined with weaving or with tufting; Extrusion of man-made filament yarn combined with weaving or with tufting; Weaving combined with dyeing or with flocking or with coating or with laminating or with metalizing; Tufting combined with dyeing or with printing; Flocking combined with dyeing or with printing; Yarn dyeing combined with weaving; Weaving combined with printing; or Printing (as standalone operation). Chapter 59 Impregnated, coated, covered or laminated textile fabrics; textile articles of a kind suitable for industrial use 59.01 Weaving combined with dyeing or with flocking or with coating or with laminating or with metalising; or Flocking combined with dyeing or with printing. 59.02 — Containing not more than 90 % by weight of textile materials: Weaving. — Others: Extrusion of man-made fibres combined with weaving. 59.03 Weaving, knitting or crocheting combined with impregnating or with coating or with covering or with laminating or with metalising; Weaving combined with printing; or Printing (as standalone operation). 59.04 Calendaring combined with dyeing, coating, laminating or metalizing. Non-originating jute fabric may be used as a backing; or Weaving combined with dyeing or with coating or with laminating or with metalising. Non-originating jute fabric may be used as a backing. 59.05 — Impregnated, coated, covered or laminated with rubber, plastics or other materials: Weaving, knitting or non-woven fabric formation combined with impregnating or with coating or with covering or with laminating or with metalising. — Others: Spinning of natural or man-made staple fibres combined with weaving; Extrusion of man-made filament yarn combined with weaving; Weaving, knitting or nonwoven fabric formation combined with dyeing or with coating or with laminating; Weaving combined with printing; or Printing (as standalone operation). 59.06 — Knitted or crocheted fabrics: Spinning of natural or man-made staple fibres combined with knitting or with crocheting; Extrusion of man-made filament yarn combined with knitting or with crocheting; Knitting or crocheting combined with rubberising; or Rubberising combined with at least two other main preparatory or finishing operations (such as calendering, shrink-resistance processes, heat setting, permanent finishing) provided that the value of non-originating materials used does not exceed 50 % of the EXW of the product. — Other fabrics made of synthetic filament yarn, containing more than 90 % by weight of textile materials: Extrusion of man-made fibres combined with weaving. — Others: Weaving, knitting or nonwoven process combined with dyeing or with coating or with rubberising; Yarn dyeing combined with weaving, knitting or nonwoven process; or Rubberising combined with at least two other main preparatory or finishing operations (such as calendering, shrink-resistance processes, heat setting, permanent finishing) provided that the value of non-originating materials used does not exceed 50 % of the EXW of the product. 59.07 Weaving, knitting or nonwoven fabric formation combined with dyeing or with printing or with coating or with impregnating or with covering; Flocking combined with dyeing or with printing; or Printing (as standalone operation). 59.08 — Incandescent gas mantles, impregnated: Production from tubular knitted or crocheted gas-mantle fabric. — Others: CTH 59.09-59.11 Spinning of natural or of man-made staple fibres combined with weaving; Extrusion of man-made fibres combined with weaving; Weaving combined with dyeing or with coating or with laminating; or Coating, flocking, laminating or metalizing combined with at least two other main preparatory or finishing operations (such as calendering, shrink-resistance processes, heat setting, permanent finishing) provided that the value of non-originating materials used does not exceed 50 % of the EXW of the product. Chapter 60 Knitted or crocheted fabrics 60.01-60.06 Spinning of natural or man-made staple fibres combined with knitting or with crocheting; Extrusion of man-made filament yarn combined with knitting or with crocheting; Knitting or crocheting combined with dyeing or with flocking or with coating or with laminating or with printing; Flocking combined with dyeing or with printing; Yarn dyeing combined with knitting or with crocheting; or Twisting or texturing combined with knitting or with crocheting provided that the value of non-originating non-twisted or non-textured yarns used does not exceed 50 % of the EXW of the product. Chapter 61 Articles of apparel and clothing accessories, knitted or crocheted 61.01-61.17 — Obtained by sewing together or otherwise assembling, two or more pieces of knitted or crocheted fabric which have been either cut to form or obtained directly to form: Knitting or crocheting combined with making-up including cutting of fabric. — Others: Spinning of natural or man-made staple fibres combined with knitting or with crocheting; Extrusion of man-made filament yarn combined with knitting or with crocheting; or Knitting and making-up in one operation. Chapter 62 Articles of apparel and clothing accessories, not knitted or crocheted 62.01 Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.02 — Embroidered: Weaving combined with making-up including cutting of fabric; or Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product. — Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.03 Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.04 — Embroidered: Weaving combined with making-up including cutting of fabric; or Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product. — Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.05 Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.06 — Embroidered: Weaving combined with making-up including cutting of fabric; or Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product. — Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.07-62.08 Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.09 — Embroidered: Weaving combined with making-up including cutting of fabric; or Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product. — Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.10 — Fire-resistant equipment of fabric covered with foil of aluminised polyester: Weaving combined with making-up including cutting of fabric; or Coating or laminating combined with making-up including cutting of fabric, provided that the value of non-originating uncoated or unlaminated fabric used does not exceed 40 % of the EXW of the product. — Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.11 — Women's, or girls' garments, embroidered: Weaving combined with making-up including cutting of fabric; or Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product. — Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.12 — Knitted or crocheted obtained by sewing together or otherwise assembling, two or more pieces of knitted or crocheted fabric which have been either cut to form or obtained directly to form: Knitting combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). — Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.13-62.14 — Embroidered: Weaving combined with making-up including cutting of fabric; Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product; or Making-up including cutting of fabric preceded by printing (as standalone operation). — Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.15 Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.16 — Fire-resistant equipment of fabric covered with foil of aluminised polyester: Weaving combined with making-up including cutting of fabric; or Coating or laminating combined with making-up including cutting of fabric, provided that the value of non-originating uncoated or unlaminated fabric used does not exceed 40 % of the EXW of the product. — Others: Weaving combined with making-up including cutting of fabric; or Making-up including cutting of fabric preceded by printing (as standalone operation). 62.17 — Embroidered: Weaving combined with making-up including cutting of fabric; Production from unembroidered fabric, provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product; or Making-up including cutting of fabric preceded by printing (as standalone operation). — Fire-resistant equipment of fabric covered with foil of aluminised polyester: Weaving combined with making-up including cutting of fabric; or Coating or laminating combined with making-up including cutting of fabric, provided that the value of non-originating uncoated or unlaminated fabric used does not exceed 40 % of the EXW of the product. — Interlinings for collars and cuffs, cut out: CTH, provided that the value of all the non-originating materials used does not exceed 40 % of the EXW of the product. — Others: Weaving combined with making-up including cutting of fabric. Chapter 63 Other made up textile articles; sets; worn clothing and worn textile articles; rags 63.01-63.04 — Of felt, of nonwovens: Nonwoven fabric formation combined with making-up including cutting of fabric. — Others: — Embroidered: Weaving or knitting or crocheting combined with making-up including cutting of fabric; or Production from unembroidered fabric (other than knitted or crocheted), provided that the value of non-originating unembroidered fabric used does not exceed 40 % of the EXW of the product. — Others: Weaving, knitting or crocheting combined with making-up including cutting of fabric. 63.05 Extrusion of man-made fibres or spinning of natural or man-made staple fibres, combined with weaving or with knitting and making-up including cutting of fabric. 63.06 — Of nonwovens: Nonwoven fabric formation combined with making-up including cutting of fabric. — Others: Weaving combined with making-up including cutting of fabric. 63.07 MaxNOM 40 % (EXW). 63.08 Each item in the set must satisfy the rule which would apply to it if it were not included in the set; however, non-originating articles may be incorporated, provided that their total value does not exceed 15 % of the EXW of the set. 63.09-63.10 CTH SECTION XII FOOTWEAR, HEADGEAR, UMBRELLAS, SUN UMBRELLAS, WALKING-STICKS, SEAT-STICKS, WHIPS, RIDING-CROPS AND PARTS THEREOF; PREPARED FEATHERS AND ARTICLES MADE THEREWITH; ARTIFICIAL FLOWERS; ARTICLE OF HUMAN HAIR Chapter 64 Footwear, gaiters and the like; parts of such articles 64.01-64.05 Production from non-originating materials of any heading, except from non-originating assemblies of uppers affixed to inner soles or to other sole components of heading 64.06. 64.06 CTH Chapter 65 Headgear and parts thereof 65.01-65.07 CTH Chapter 66 Umbrellas, sun umbrellas, walking-sticks, seat-sticks, whips, riding-crops and parts thereof 66.01-66.03 CTH; or MaxNOM 50 % (EXW). Chapter 67 Prepared feathers and down and articles made of feathers or of down; artificial flowers; articles of human hair 67.01-67.04 CTH SECTION XIII ARTICLES OF STONE, PLASTER, CEMENT, ASBESTOS, MICA OR SIMILAR MATERIALS; CERAMIC PRODUCTS; GLASS AND GLASSWARE Chapter 68 Articles of stone, plaster, cement, asbestos, mica or similar materials 68.01-68.15 CTH; or MaxNOM 70 % (EXW). Chapter 69 Ceramic products 69.01-69.14 CTH Chapter 70 Glass and glassware 70.01-70.09 CTH; or MaxNOM 50 % (EXW). 70.10 CTH 70.11 CTH; or MaxNOM 50 % (EXW). 70.13 CTH except from non-originating materials of heading 70.10. 70.14-70.20 CTH; or MaxNOM 50 % (EXW). SECTION XIV NATURAL OR CULTURED PEARLS, PRECIOUS OR SEMI-PRECIOUS STONES, PRECIOUS METALS, METALS CLAD WITH PRECIOUS METAL, AND ARTICLES THEREOF; IMITATION JEWELLERY; COIN Chapter 71 Natural or cultured pearls, precious or semi-precious stones, precious metals, metals clad with precious metal, and articles thereof; imitation jewellery; coin 71.01-71.05 Production from non-originating materials of any heading. 71.06 — Unwrought: CTH except from non-originating materials of headings 71.06, 71.08 and 71.10; Electrolytic, thermal or chemical separation of non-originating precious metals of headings 71.06, 71.08 and 71.10; or Fusion or alloying of non-originating precious metals of headings 71.06, 71.08 and 71.10 with each other or with base metals or purification. — Semi-manufactured or in powder form: Production from non-originating unwrought precious metals. 71.07 Production from non-originating materials of any heading. 71.08 — Unwrought: CTH except from non-originating materials of headings 71.06, 71.08 and 71.10; Electrolytic, thermal or chemical separation of non-originating precious metals of headings 71.06, 71.08 and 71.10; or Fusion or alloying of non-originating precious metals of headings 71.06, 71.08 and 71.10 with each other or with base metals or purification. — Semi-manufactured or in powder form: Production from non-originating unwrought precious metals. 71.09 Production from non-originating materials of any heading. 71.10 — Unwrought: CTH except from non-originating materials of headings 71.06, 71.08 and 71.10; Electrolytic, thermal or chemical separation of non-originating precious metals of headings 71.06, 71.08 and 71.10; or Fusion or alloying of non-originating precious metals of headings 71.06, 71.08 and 71.10 with each other or with base metals or purification. — Semi-manufactured or in powder form: Production from non-originating unwrought precious metals. 71.11 Production from non-originating materials of any heading. 71.12-71.18 CTH SECTION XV BASE METALS AND ARTICLES OF BASE METAL Chapter 72 Iron and Steel 72.01-72.06 CTH 72.07 CTH except from non-originating materials of heading 72.06. 72.08-72.17 CTH except from non-originating materials of headings 72.08 to 72.17. 72.18 CTH 72.19-72.23 CTH except from non-originating materials of headings 72.19 to 72.23. 72.24 CTH 72.25-72.29 CTH except from non-originating materials of headings 72.25 to 72.29. Chapter 73 Articles of iron or steel 7301.10 CC except from non-originating materials of headings 72.08 to 72.17. 7301.20 CTH 73.02 CC except from non-originating materials of headings 72.08 to 72.17. 73.03 CTH 73.04-73.06 CC except from non-originating materials of headings 72.13 to 72.17, 72.21 to 72.23 and 72.25 to 72.29. 73.07 — Tube or pipe fittings of stainless steel: CTH except from non-originating forged blanks; however, non-originating forged blanks may be used provided that their value does not exceed 50 % of the EXW of the product. — Others: CTH 73.08 CTH except from non-originating materials of subheading 7301.20. 7309.00-7315.19 CTH 7315.20 CTH; or MaxNOM 50 % (EXW). 7315.81-7326.90 CTH Chapter 74 Copper and articles thereof 74.01-74.02 CTH 74.03 Production from non-originating materials of any heading. 74.04-74.07 CTH 74.08 CTH and MaxNOM 50 % (EXW). 74.09-74.19 CTH Chapter 75 Nickel and articles thereof 75.01 CTH 75.02 Production from non-originating materials of any heading. 75.03-75.08 CTH Chapter 76 Aluminium and articles thereof 76.01 CTH and MaxNOM 50 % (EXW); or Thermal or electrolytic treatment from unalloyed aluminium or waste and scrap of aluminium. 76.02 CTH 76.03-76.16 CTH and MaxNOM 50 % (EXW) (3). Chapter 78 Lead and articles thereof 7801.10 Production from non-originating materials of any heading. 7801.91-7806.00 CTH Chapter 79 Zinc and articles thereof 79.01-79.07 CTH Chapter 80 Tin and articles thereof 80.01-80.07 CTH Chapter 81 Other base metals; cermets; articles thereof 81.01-81.13 Production from non-originating materials of any heading. Chapter 82 Tools, implements, cutlery, spoons and forks, of base metal; parts thereof of base metal 8201.10-8205.70 CTH; or MaxNOM 50 % (EXW). 8205.90 CTH, however, non-originating tools of heading 82.05 may be incorporated into the set, provided that their total value does not exceed 15 % of the EXW of the set. 82.06 CTH except from non-originating materials of headings 82.02 to 82.05; however, non-originating tools of headings 82.02 to 82.05 may be incorporated into the set, provided that their total value does not exceed 15 % of the EXW of the set. 82.07-82.15 CTH; or MaxNOM 50 % (EXW). Chapter 83 Miscellaneous articles of base metal 83.01-83.11 CTH; or MaxNOM 50 % (EXW). SECTION XVI MACHINERY AND MECHANICAL APPLIANCE; ELECTRICAL EQUIPMENT; PARTS THEREOF; SOUND RECORDERS AND REPRODUCERS, TELEVISION IMAGE AND SOUND RECORDERS AND REPRODUCERS, AND PARTS AND ACCESSORIES OF SUCH ARTICLES Chapter 84 Nuclear reactors, boilers, machinery and mechanical appliances; parts thereof 84.01-84.06 CTH; or MaxNOM 50 % (EXW). 84.07-84.08 MaxNOM 50 % (EXW). 84.09-84.12 CTH; or MaxNOM 50 % (EXW). 8413.11-8415.10 CTSH; or MaxNOM 50 % (EXW). 8415.20 CTH; or MaxNOM 50 % (EXW). 8415.81-8415.90 CTSH; or MaxNOM 50 % (EXW). 84.16-84.20 CTH; or MaxNOM 50 % (EXW). 84.21 CTSH; or MaxNOM 50 % (EXW). 84.22-84.24 CTH; or MaxNOM 50 % (EXW). 84.25-84.30 CTH except from non-originating materials of heading 84.31; or MaxNOM 50 % (EXW). 84.31-84.43 CTH; or MaxNOM 50 % (EXW). 84.44-84.47 CTH except from non-originating materials of heading 84.48; or MaxNOM 50 % (EXW). 84.48-84.55 CTH; or MaxNOM 50 % (EXW). 84.56-84.65 CTH except from non-originating materials of heading 84.66; or MaxNOM 50 % (EXW). 84.66-84.68 CTH; or MaxNOM 50 % (EXW). 84.70-84.72 CTH except from non-originating materials of heading 84.73; or MaxNOM 50 % (EXW). 84.73-84.78 CTH; or MaxNOM 50 % (EXW). 8479.10-8479.40 CTSH; or MaxNOM 50 % (EXW). 8479.50 CTH; or MaxNOM 50 % (EXW). 8479.60-8479.82 CTSH; or MaxNOM 50 % (EXW). 8479.89 CTH; or MaxNOM 50 % (EXW). 8479.90 CTSH; or MaxNOM 50 % (EXW). 84.80 CTH; or MaxNOM 50 % (EXW). 84.81 CTSH; or MaxNOM 50 % (EXW). 84.82-84.87 CTH; or MaxNOM 50 % (EXW). Chapter 85 Electrical machinery and equipment and parts thereof; sound recorders and reproducers, television image and sound recorders and reproducers, and parts and accessories of such articles 85.01-85.02 CTH except from non-originating materials of heading 85.03; or MaxNOM 50 % (EXW). 85.03-85.06 CTH; or MaxNOM 50 % (EXW). 85.07 — Accumulators containing one or more battery cells or battery modules and the circuitry to interconnect them amongst themselves, often referred to as "battery packs", of a kind used as the primary source of electrical power for propulsion of vehicles of headings 87.02, 87.03 and 87.04 CTH except from non-originating active cathode materials; or MaxNOM 30 % (EXW) (4). — Battery cells, battery modules and parts thereof, intended to be incorporated into an electric accumulator of a kind used as the primary source of electrical power for propulsion of vehicles of headings 87.02, 87.03 and 87.04 CTH except from non-originating active cathode materials; or MaxNOM 35 % (EXW) (5) — others CTH; or MaxNOM 50 % (EXW). 85.08-85.18 CTH; or MaxNOM 50 % (EXW). 85.19-85.21 CTH except from non-originating materials of heading 85.22; or MaxNOM 50 % (EXW). 85.22-85.23 CTH; or MaxNOM 50 % (EXW). 85.25-85.27 CTH except from non-originating materials of heading 85.29; or MaxNOM 50 % (EXW). 85.28-85.34 CTH; or MaxNOM 50 % (EXW). 85.35-85.37 CTH except from non-originating materials of heading 85.38; or MaxNOM 50 % (EXW). 8538.10-8541.90 CTH; or MaxNOM 50 % (EXW). 8542.31-8542.39 CTH; Non-originating materials undergo a diffusion; or MaxNOM 50 % (EXW). 8542.90-8543.90 CTH; or MaxNOM 50 % (EXW). 85.44-85.48 MaxNOM 50 % (EXW). SECTION XVII VEHICLES, AIRCRAFT, VESSELS AND ASSOCIATED TRANSPORT EQUIPMENT Chapter 86 Railway or tramway locomotives, rolling-stock and parts thereof; railway or tramway track fixtures and fittings and parts thereof; mechanical (including electro-mechanical) traffic signalling equipment of all kinds 86.01-86.09 CTH except from non-originating materials of heading 86.07; or MaxNOM 50 % (EXW). Chapter 87 Vehicles other than railway or tramway rolling-stock, and parts and accessories thereof 87.01 MaxNOM 45 % (EXW). 87.02-87.04 — vehicles with both internal combustion piston engine and electric motor as motors for propulsion capable of being charged by plugging to external source of electric power ("plug-in hybrid"); — vehicles with only electric motor for propulsion MaxNOM 45 % (EXW) and battery packs of heading 85.07 of a kind used as the primary source of electrical power for propulsion of the vehicle must be originating (6). — others MaxNOM 45 % (EXW) (7). 87.05-87.07 MaxNOM 45 % (EXW). 87.08-87.11 CTH; or MaxNOM 50 % (EXW). 87.12 MaxNOM 45 % (EXW). 87.13-87.16 CTH; or MaxNOM 50 % (EXW). Chapter 88 Aircraft, spacecraft, and parts thereof 88.01-88.05 CTH; or MaxNOM 50 % (EXW). Chapter 89 Ships, boats and floating structures 89.01-89.08 CC; or MaxNOM 40 % (EXW). SECTION XVIII OPTICAL, PHOTOGRAPHIC, CINEMATOGRAPHIC, MEASURING, CHECKING, PRECISION, MEDICAL OR SURGICAL INSTRUMENTS AND APPARATUS; CLOCKS AND WATCHES; MUSICAL INSTRUMENTS; PARTS AND ACCESSORIES THEREOF Chapter 90 Optical, photographic, cinematographic, measuring, checking, precision, medical or surgical instruments and apparatus; parts and accessories thereof 9001.10-9001.40 CTH; or MaxNOM 50 % (EXW). 9001.50 CTH; Surfacing of the semi-finished lens into a finished ophthalmic lens with optical corrective power meant to be mounted on a pair of spectacles; Coating of the lens through appropriated treatments to improve vision and ensure protection of the wearer; or MaxNOM 50 % (EXW). 9001.90-9033.00 CTH; or MaxNOM 50 % (EXW). Chapter 91 Clocks and watches and parts thereof 91.01-91.14 CTH; or MaxNOM 50 % (EXW). Chapter 92 Musical instruments; parts and accessories of such articles 92.01-92.09 MaxNOM 50 % (EXW). SECTION XIX ARMS AND AMMUNITION; PARTS AND ACCESSORIES THEREOF Chapter 93 Arms and ammunition; parts and accessories thereof 93.01-93.07 MaxNOM 50 % (EXW). SECTION XX MISCELLANEOUS MANUFACTURED ARTICLES Chapter 94 Furniture; bedding, mattresses, mattress supports, cushions and similar stuffed furnishings; lamps and lighting fittings, not elsewhere specified or included; illuminated signs, illuminated name-plates and the like; prefabricated buildings 94.01-94.06 CTH; or MaxNOM 50 % (EXW). Chapter 95 Toys, games and sports requisites; parts and accessories thereof 95.03-95.08 CTH; or MaxNOM 50 % (EXW). Chapter 96 Miscellaneous manufactured articles 96.01-96.04 CTH; or MaxNOM 50 % (EXW). 96.05 Each item in the set shall satisfy the rule which would apply to it if it were not included in the set, provided that non-originating articles may be incorporated, provided that their total value does not exceed 15 % of the EXW of the set. 96.06-9608.40 CTH; or MaxNOM 50 % (EXW). 9608.50 Each item in the set shall satisfy the rule which would apply to it if it were not included in the set, provided that non-originating articles may be incorporated, provided that their total value does not exceed 15 % of the EXW of the set. 9608.60-96.20 CTH; or MaxNOM 50 % (EXW). SECTION XXI WORKS OF ART, COLLECTORS' PIECES AND ANTIQUES Chapter 97 Works of Art, Collectors' Pieces and Antiques 97.01-97.06 CTH (1) Prepared or preserved tunas, skipjack and bonito (Sarda spp.), whole or in pieces (excl. minced) classified under subheading 1604.14 may be considered as originating under alternative product-specific rules of origin within annual quotas as specified in Annex 4. (2) Prepared or preserved tunas, skipjack or other fish of genus Euthynnus (excl. whole or in pieces) classified under subheading 1604.20 may be considered as originating under alternative product-specific rules of origin within annual quotas as specified in Annex 4. (3) Certain aluminium products may be considered as originating under alternative product-specific rules of origin with annual quotas as specified in Annex 4. (4) For the period from the entry into force of this Agreement until 31 December 2026 alternative product-specific rules of origin apply, as specified in Annex 5. (5) For the period from the entry into force of this Agreement until 31 December 2026 alternative product-specific rules of origin apply, as specified in Annex 5. (6) For the period from the entry into force of this Agreement until 31 December 2026 alternative product-specific rules of origin apply, as specified in Annex 5. (7) For hybrid vehicles with both internal combustion engine and electric motor as motors for propulsion, other than those capable of being charged by plugging to external source of electric power, alternative product-specific rules of origin apply for the period from the entry into force of this Agreement until 31 December 2026, as specified in Annex 5. ANNEX 4 ORIGIN QUOTAS AND ALTERNATIVES TO THE PRODUCT-SPECIFIC RULES OF ORIGIN IN ANNEX 3 Common provisions 1. For the products listed in the tables below, the corresponding rules of origin are alternatives to those set out in Annex 3, within the limits of the applicable annual quota. 2. A statement on origin made out pursuant to this Annex shall contain the following statement: "Origin quotas - Product originating in accordance with Annex 4". 3. In the Union, any quantities referred to in this Annex shall be managed by the European Commission, which shall take all administrative actions it deems advisable for their efficient management in respect of the applicable legislation of the Union. 4. In the United Kingdom, any quantities referred to in this Annex shall be managed by its customs authority, which shall take all administrative actions it deems advisable for their efficient management in respect of the applicable legislation in the United Kingdom. 5. The importing Party shall manage the origin quotas on a first-come first-served basis and shall calculate the quantity of products entered under these origin quotas on the basis of that Party's imports. SECTION 1 Annual quota allocation for canned tuna Harmonised system classification (2017) Product description Alternative product-specific rule Annual quota for exports from the Union to the United Kingdom (net weight) Annual quota for exports from the United Kingdom to the Union (net weight) 1604.14 Prepared or preserved tunas, skipjack and bonito (Sarda spp.), whole or in pieces (excl. minced) CC 3 000 tonnes 3 000 tonnes 1604.20 Other prepared or preserved fish Of tuna, skipjack or other fish of the genus Euthynnus (excl. whole or in pieces) CC 4 000 tonnes 4 000 tonnes Of other fish - - - SECTION 2 Annual quota allocation for aluminium products (1) Table 1 Quotas applicable from 1 January 2021 until 31 December 2023 Harmonised system classification (2017) Product description Alternative product-specific rule Annual quota for exports from the Union to the United Kingdom (net weight) Annual quota for exports from the United Kingdom to the Union (net weight) 76.03, 76.04, 76.06, 76.08-76.16 Aluminium products and articles of aluminium (excluding aluminium wire and aluminium foil) CTH 95 000 tonnes 95 000 tonnes 76.05 Aluminium wire CTH except from non-originating materials of heading 76.04 76.07 Aluminium foil CTH except from non-originating materials of heading 76.06 Table 2 Quotas applicable from 1 January 2024 until 31 December 2026 Harmonised system classification (2017) Product description Alternative product-specific rule Annual quota for exports from the Union to the United Kingdom (net weight) Annual quota for exports from the United Kingdom to the Union (net weight) 76.03, 76.04, 76.06, 76.08-76.16 Aluminium products and articles of aluminium (excluding aluminium wire and aluminium foil) CTH 72 000 tonnes 72 000 tonnes 76.05 Aluminium wire CTH except from non-originating materials of heading 76.04 76.07 Aluminium foil CTH except from non-originating materials of heading 76.06 Table 3 Quotas applicable from 1 January 2027 onwards Harmonised system classification (2017) Product description Alternative product-specific rule Annual quota for exports from the Union to the United Kingdom (net weight) Annual quota for exports from the United Kingdom to the Union (net weight) 76.04 Aluminium bars, rods and profiles CTH 57 500 tonnes 57 500 tonnes 76.06 Aluminium plates, sheets and strip, of a thickness exceeding 0,2 mm CTH 76.07 Aluminium foil CTH except from non-originating materials of heading 76.06 Review of quotas for aluminium products in Table 3 in Section 2 1. Not earlier than 5 years from the entry into force of this Agreement and not earlier than 5 years from the completion of any review referred to in this paragraph, the Trade Partnership Committee, at the request of either Party and assisted by the Trade Specialised Committee on Customs Cooperation and Rules of Origin, shall review the quotas for aluminium contained in Table 3 in Section 2. 2. The review referred to in paragraph 1 shall be made on the basis of available information about the market conditions in both Parties and information about their imports and exports of relevant products. 3. On the basis of the result of a review carried out pursuant to paragraph 1, the Partnership Council may adopt a decision to increase or maintain the quantity, to change the scope, or to apportion or change any apportionment between products, of the quotas for aluminium contained in Table 3 in Section 2. (1) The quantities listed in each table in Section 2 are the entire quota quantities available (for exports from the Union to the United Kingdom, and for exports from the United Kingdom to the Union, respectively) for all the products listed in that table. ANNEX 5 TRANSITIONAL PRODUCT-SPECIFIC RULES FOR ELECTRIC ACCUMULATORS AND ELECTRIFIED VEHICLES SECTION 1 Interim product-specific rules applicable from the entry into force of this Agreement until 31 December 2023 1. For the products listed in column 1 below, the product-specific rule listed in column 2 shall apply for the period from the entry into force of this Agreement until 31 December 2023. Column 1 Harmonised System classification (2017) including specific description Column 2 Product-specific rule of origin applicable from the entry into force of this Agreement until 31 December 2023 85.07 — Accumulators containing one or more battery cells or battery modules and the circuitry to interconnect them amongst themselves, often referred to as "battery packs", of a kind used as the primary source of electrical power for propulsion of vehicles of headings 87.02, 87.03 and 87.04 CTSH; Assembly of battery packs from non-originating battery cells or battery modules; or MaxNOM 70 % (EXW) — Battery cells, battery modules, and parts thereof, intended to be incorporated into an electric accumulator of a kind used as the primary source of electrical power for propulsion of vehicles of headings 87.02, 87.03 and 87.04 CTH; or MaxNOM 70 % (EXW) 87.02-87.04 — vehicles with both internal combustion engine and electric motor as motors for propulsion other than those capable of being charged by plugging to external source of electric power ("hybrid"); — vehicles with both internal combustion piston engine and electric motor as motors for propulsion capable of being charged by plugging to external source of electric power ("plug-in hybrid"); — vehicles with only electric motor for propulsion MaxNOM 60 % (EXW) SECTION 2 Interim product-specific rules applicable from 1 January 2024 until 31 December 2026 1. For the products listed in column 1 below, the product specific rule listed in column 2 shall apply for the period from 1 January 2024 until 31 December 2026. Column 1 Harmonised System classification (2017) including specific description Column 2 Product-specific rule of origin applicable from 1 January 2024 until 31 December 2026 85.07 — Accumulators containing one or more battery cells or battery modules and the circuitry to interconnect them amongst themselves, often referred to as "battery packs", of a kind used as the primary source of electrical power for propulsion of vehicles of headings 87.02, 87.03 and 87.04 CTH except from non-originating active cathode materials; or MaxNOM 40 % (EXW) — Battery cells, battery modules, and parts thereof, intended to be incorporated into an electric accumulator of a kind used as the primary source of electrical power for propulsion of vehicles of headings 87.02, 87.03 and 87.04 CTH except from non-originating active cathode materials; or MaxNOM 50 % (EXW) 87.02-87.04 — vehicles with both internal combustion engine and electric motor as motors for propulsion other than those capable of being charged by plugging to external source of electric power ("hybrid"); — vehicles with both internal combustion piston engine and electric motor as motors for propulsion capable of being charged by plugging to external source of electric power ("plug-in hybrid"); — vehicles with only electric motor for propulsion MaxNOM 55 % (EXW) SECTION 3 Review of product-specific rules for heading 85.07 1. Not earlier than 4 years from the entry into force of this Agreement, the Trade Partnership Committee shall, on request of either Party and assisted by the Trade Specialised Committee on Customs Cooperation and Rules of Origin, review the product-specific rules for heading 85.07 applicable as from 1 January 2027, contained in Annex 3. 2. The review referred to in paragraph 1, shall be made on the basis of available information about the markets within the Parties, such as the availability of sufficient and suitable originating materials, the balance between supply and demand and other relevant information. 3. On the basis of the results of the review carried out pursuant to paragraph 1, the Partnership Council may adopt a decision to amend the product-specific rules for heading 85.07 applicable as from 1 January 2027, contained in Annex 3. ANNEX 6 SUPPLIER’S DECLARATION 1. A supplier’s declaration shall have the content set out in this Annex. 2. Except in the cases referred to in point 3, a supplier’s declaration shall be made out by the supplier for each consignment of products in the form provided for in Appendix 6-A and annexed to the invoice, or to any other document describing the products concerned in sufficient detail to enable them to be identified. 3. Where a supplier regularly supplies a particular customer with products for which the production carried out in a Party is expected to remain constant for a period of time, that supplier may provide a single supplier’s declaration to cover subsequent consignments of those products (the "long-term supplier’s declaration"). A long-term supplier’s declaration is normally valid for a period of up to two years from the date of making out the declaration. The customs authorities of the Party where the declaration is made out may lay down the conditions under which longer periods may be used. The long-term supplier’s declaration shall be made out by the supplier in the form provided for in Appendix 6-B and shall describe the products concerned in sufficient detail to enable them to be identified. The supplier shall inform the customer immediately if the long-term supplier’s declaration ceases to apply to the products supplied. 4. The supplier making out a declaration shall be prepared to submit at any time, at the request of the customs authorities of the Party where the declaration is made out, all appropriate documents proving that the information given on that declaration is correct. Appendix 6-A SUPPLIER'S DECLARATION The supplier's declaration, the text of which is provided below, must be made out in accordance with the footnotes. However, the footnotes do not have to be reproduced. SUPPLIER'S DECLARATION I, the undersigned, the supplier of the products covered by the annexed document, declare that: 1. The following materials which do not originate in [indicate the name of the relevant Party] have been used in [indicate the name of the relevant Party] to produce these products: Description of the products supplied(1) Description of non-originating materials used HS heading of non-originating materials used(2) Value of non-originating materials used(2)(3) Total value 2. All the other materials used in [indicate the name of the relevant Party] to produce those products originate in [indicate the name of the relevant Party] I undertake to make available any further supporting documents required. … (Place and Date) … (Name and position of the undersigned, name and address of company) … (Signature)(6) Appendix 6-B LONG-TERM SUPPLIER'S DECLARATION The long-term supplier's declaration, the text of which is given below, must be made out in accordance with the footnotes. However, the footnotes do not have to be reproduced. LONG-TERM SUPPLIER'S DECLARATION I, the undersigned, the supplier of the products covered by the annexed document, which are regularly supplied to (4) …, declare that: 1. The following materials which do not originate in [indicate the name of the relevant Party] have been used in [indicate the name of the relevant Party] to produce these products: Description of the products supplied(1) Description of non-originating materials used HS heading of non-originating materials used(2) Value of non-originating materials used(2)(3) Total value 2. All the other materials used in [indicate the name of the relevant Party] to produce those products originate in a Party [indicate the name of the relevant Party]; This declaration is valid for all subsequent consignments of these products dispatched from … to … (5) I undertake to inform … (4) immediately if this declaration ceases to be valid. … (Place and Date) … (Name and position of the undersigned, name and address of company) … (Signature)(6) Footnotes (1) Where the invoice or other document to which the declaration is annexed relates to different kinds of products, or to products which do not incorporate non-originating materials to the same extent, the supplier must clearly differentiate them. (2) The information requested does not have to be given unless it is necessary. Examples: One of the rules for garments of Chapter 62 provides "Weaving combined with making-up including cutting of fabric". If a manufacturer of such garments in a Party uses fabric imported from the other Party which has been obtained there by weaving non-originating yarn, it is sufficient for the supplier in the latter Party to describe in his declaration the non-originating material used as yarn, without it being necessary to indicate the HS heading and the value of such yarn. A producer of wire of iron of HS heading 72.17 who has produced it from non-originating iron bars should indicate in the second column "bars of iron". Where that wire is to be used in the production of a machine for which the rule contains a limitation for all non-originating materials used to a certain percentage value, it is necessary to indicate in the third column the value of non-originating bars. (3) "Value of non-originating materials used" means the value of the non-originating materials used in the production of the product, which is its customs value at the time of importation, including freight, insurance if appropriate, packing and all other costs incurred in transporting the materials to the importation port in the Party where the producer of the product is located; where the value of the non-originating materials is not known and cannot be ascertained, the first ascertainable price paid for the non-originating materials in the Union or in the United Kingdom is used. (4) Name and address of the customer (5) Insert dates (6) This field may contain an electronic signature, a scanned image or other visual representation of the signer’s handwritten signature instead of original signatures, where appropriate. ANNEX 7 TEXT OF THE STATEMENT ON ORIGIN The statement on origin referred to in Article 56 of this Agreement shall be made out using the text set out below in one of the following language versions and in accordance with the laws and regulations of the exporting Party. If the statement on origin is handwritten, it shall be written in ink in printed characters. The statement on origin shall be made out in accordance with the respective footnotes. The footnotes do not have to be reproduced. Bulgarian version Croatian version Czech version Danish version Dutch version English version Estonian version Finnish version French version German version Greek version Hungarian version Italian version Latvian version Lithuanian version Maltese version Polish version Portuguese version Romanian version Slovak version Slovenian version Spanish version Swedish version (Period: from … to … (1)) The exporter of the products covered by this document (Exporter Reference No ...(2)) declares that, except where otherwise clearly indicated, these products are of ...(3) preferential origin. …(4) (Place and date) … (Name of the exporter) (1) If the statement on origin is completed for multiple shipments of identical originating products within the meaning of point (b) of Article 56(4) of this Agreement, indicate the period for which the statement on origin is to apply. That period shall not exceed 12 months. All importations of the product must occur within the period indicated. If a period is not applicable, the field may be left blank. (2) Indicate the reference number by which the exporter is identified. For the Union exporter, this will be the number assigned in accordance with the laws and regulations of the Union. For the United Kingdom exporter, this will be the number assigned in accordance with the laws and regulations applicable within the United Kingdom. Where the exporter has not been assigned a number, this field may be left blank. (3) Indicate the origin of the product: the United Kingdom or the Union. (4) Place and date may be omitted if the information is contained on the document itself. ANNEX 8 JOINT DECLARATION CONCERNING THE PRINCIPALITY OF ANDORRA 1. Products originating in the Principality of Andorra that fall within Chapters 25 to 97 of the Harmonised System shall be accepted by the United Kingdom as originating in the Union within the meaning of this Agreement. 2. Paragraph 1 only applies if, by virtue of the customs union established by Council Decision 90/680/EEC of 26 November 1990 on the conclusion of an agreement in the form of an exchange of letters between the European Economic Community and the Principality of Andorra, the Principality of Andorra applies to products originating in the United Kingdom the same preferential tariff treatment as the Union applies to such products. 3. Part Two, Heading One, Title I, Chapter 2 of this Agreement applies mutatis mutandis for the purpose of defining the originating status of products referred to in paragraph 1 of this Joint Declaration. ANNEX 9 JOINT DECLARATION CONCERNING THE REPUBLIC OF SAN MARINO 1. Products originating in the Republic of San Marino shall be accepted by the United Kingdom as originating in the Union within the meaning of this Agreement. 2. Paragraph 1 only applies if, by virtue of the Agreement on Cooperation and Customs Union between the European Economic Community and the Republic of San Marino, done at Brussels on 16 December 1991, the Republic of San Marino applies to products originating in the United Kingdom the same preferential tariff treatment as the Union applies to such products. 3. Part Two, Heading One, Title I, Chapter 2 of this Agreement applies mutatis mutandis for the purposes of defining the originating status of products referred to in paragraph 1 of this Joint Declaration. ANNEX 10 CRITERIA REFERRED TO IN POINT (d) OF ARTICLE 87 The criteria referred to in point (d) of Article 87 of this Agreement are: (a) the information made available by the exporting Party for the purposes of obtaining import authorisation of a given product into the importing party according to Article 75 of this Agreement; (b) the outcome of audits and verifications by the importing party in accordance with Article 79 of this Agreement; (c) the frequency and severity of non-compliance detected by the importing party on products from the exporting party; (d) the exporting operators' past record as regards compliance with the requirements of the importing party; and (e) available scientific assessments and any other pertinent information regarding the risk associated with the products. ANNEX 11 MOTOR VEHICLES AND EQUIPMENT AND PARTS THEREOF Article 1 Definitions 1. For the purposes of this Annex, the following definitions apply: (a) "WP.29" means the World Forum for Harmonisation of Vehicle Regulations within the framework of the United Nations Economic Commission for Europe ("UNECE"); (b) "1958 Agreement" means the Agreement Concerning the Adoption of Harmonized Technical United Nations Regulations for Wheeled Vehicles, Equipment and Parts which can be Fitted and/or be Used on Wheeled Vehicles and the Conditions for Reciprocal Recognition of Approvals Granted on the Basis of these United Nations Regulations, done at Geneva on 20 March 1958, administered by the WP.29, and all subsequent amendments and revisions thereof; (c) "1998 Agreement" means the Agreement concerning the Establishing of Global Technical Regulations for Wheeled Vehicles, Equipment and Parts which can be Fitted and/or be Used on Wheeled Vehicles, done at Geneva on 25 June 1998, administered by the WP.29, and all subsequent amendments and revisions thereof; (d) "UN Regulations" means Regulations adopted in accordance with the 1958 Agreement; (e) "GTR" means a Global Technical Regulation established and placed on the Global Registry in accordance with the 1998 Agreement; (f) "HS 2017" means the 2017 edition of the Harmonised System Nomenclature issued by the World Customs Organization; (g) "type approval" means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements; (h) "type-approval certificate" means the document whereby an approval authority officially certifies that a type of vehicle, system, component or separate technical unit is type-approved. 2. Terms referred to in this Annex shall have the same meaning as they have in the 1958 Agreement or in Annex 1 to the TBT Agreement. Article 2 Product scope This Annex applies to the trade between the Parties of all categories of motor vehicles, equipment and parts thereof, as defined in Paragraph 1 of UNECE Consolidated Resolution on the Construction of Vehicles (R.E.3) (1), falling under, inter alia, Chapters 40, 84, 85, 87 and 94 of the HS 2017 (hereinafter referred to as "products covered"). Article 3 Objectives With regard to the products covered, the objectives of this Annex are to: (a) eliminate and prevent any unnecessary technical barriers to bilateral trade; (b) promote the compatibility and convergence of regulations based on international standards; (c) promote the recognition of approvals based on approval schemes applied under the agreements administered by WP.29; (d) reinforce competitive market conditions based on principles of openness, non-discrimination and transparency; (e) promote high levels of protection of human health, safety and the environment; and (f) maintain cooperation on issues of mutual interest to foster continued mutually beneficial development in trade. Article 4 Relevant international standards The Parties recognise that the WP.29 is the relevant international standardising body and that UN Regulations and GTRs under the 1958 Agreement and 1998 Agreement are relevant international standards for the products covered by this Annex. Article 5 Regulatory convergence based on relevant international standards 1. The Parties shall refrain from introducing or maintaining any domestic technical regulation, marking, or conformity assessment procedure diverging from UN Regulations or GTRs in areas covered by such Regulations or GTRs, including where the relevant UN Regulations or GTRs have not been completed but their completion is imminent, unless there are substantiated reasons why a specific UN Regulation or GTR is an ineffective or inappropriate means for the fulfilment of legitimate objectives pursued, for example, in the areas of road safety or the protection of the environment or human health. 2. A Party which introduces a divergent domestic technical regulation, marking, or conformity assessment procedure as referred to in paragraph 1, at the request of the other Party, shall identify the parts of the domestic technical regulation, marking, or conformity assessment procedure which substantially diverge from the relevant UN Regulations or GTRs and provide justification for the divergence. 3. Each Party shall systematically consider applying UN Regulations adopted after the entry into force of this Agreement, and shall inform each other of any changes regarding the implementation of those UN Regulations in its respective domestic legal system following the protocol established under the 1958 Agreement and in line with Articles 8 and 9. 4. Insofar as a Party has introduced or maintains domestic technical regulations, markings or conformity assessment procedures that diverge from UN Regulations or GTRs as permitted by paragraph 1, that Party shall review those domestic technical regulations, markings or conformity assessment procedures at regular intervals, preferably not exceeding five years, with a view to increasing their convergence with the relevant UN Regulations or GTRs. When reviewing their domestic technical regulations, markings and conformity assessment procedures, each Party shall consider whether the justification for the divergence still exists. The outcome of these reviews, including any scientific and technical information used, shall be notified to the other Party upon request. 5. Each Party shall refrain from introducing or maintaining domestic technical regulations, markings, or conformity assessment procedures which have the effect of prohibiting, restricting or increasing the burden for the importation and putting into service on their domestic market of products type-approved under UN Regulations for the areas covered by those UN Regulations unless such domestic technical regulations, markings or conformity assessment procedures are explicitly provided for by those UN Regulations. Article 6 Type approval and market surveillance 1. Each Party shall accept on its market products which are covered by a valid UN type-approval certificate as compliant with its domestic technical regulations, markings and conformity assessment procedures, without requiring any further testing or marking to verify or attest compliance with any requirement covered by the UN type-approval certificate concerned. In the case of vehicle approvals, the UN Universal International Whole Vehicle Type Approval (U-IWVTA) shall be considered valid in respect of the requirements covered by the U-IWVTA. UN type-approval certificates issued by a Party can only be considered valid if that Party has acceded to the relevant UN Regulations. 2. Each Party shall only be required to accept valid UN type-approval certificates issued pursuant to the latest version of the UN Regulations it has acceded to. 3. For the purpose of paragraph 1, the following shall be considered sufficient proof of the existence of a valid UN type-approval: (a) for whole vehicles, a valid UN Declaration of Conformance certifying compliance with a U-IWVTA; (b) for equipment and parts, a valid UN type-approval mark affixed to the product; or (c) for equipment and parts to which a UN type-approval mark cannot be affixed, a valid UN type-approval certificate. 4. For the purpose of conducting market surveillance, the competent authorities of a Party may verify that the products covered comply, as appropriate, with (a) all the domestic technical regulations of that Party; or (b) the UN Regulations with which compliance has been attested, in accordance with this Article, by a valid UN Declaration of Conformance certifying compliance with a U-IWVTA in the case of whole vehicles, or by a valid UN type-approval mark affixed to the product or a valid UN type-approval certificate in the case of equipment and parts. Such verifications shall be carried out by random sampling in the market and in accordance with the technical regulations referred to in point (a) or (b) of this paragraph, as the case may be. 5. The Parties shall endeavour to cooperate in the field of market surveillance to support the identification and addressing of non-conformities of vehicles, systems, components or separate technical units. 6. A Party may take any appropriate measures with respect to vehicles, systems, components or separate technical units that present a serious risk to the health or safety of persons or with regard to other aspects of the protection of public interests, or that otherwise do not comply with applicable requirements. Such measures may include prohibiting or restricting the making available on the market, the registration or the entry into service of the vehicles, systems, components or separate technical units concerned, or withdrawing them from the market or recalling them. A Party that adopts or maintains such measures shall promptly inform the other Party of those measures and, at the request of the other Party, shall provide its reasons for adopting those measures. Article 7 Products with new technologies or new features 1. Neither Party shall refuse or restrict the access to its market of a product that is covered by this Annex and that has been approved by the exporting Party on the grounds that the product incorporates a new technology or a new feature that the importing Party has not yet regulated, unless it can demonstrate that it has reasonable grounds for believing that the new technology or new feature creates a risk for human health, safety or the environment. 2. If a Party decides to refuse the access to its market or requires the withdrawal from its market of a product of the other Party covered by this Annex on the grounds that it incorporates a new technology or a new feature creating a risk for human health, safety or the environment, it shall promptly notify that decision to the other Party and to the economic operator or operators concerned. The notification shall include all relevant scientific or technical information taken into account in the decision. Article 8 Cooperation 1. In order to further facilitate trade in motor vehicles, their parts and equipment, and to prevent market access problems, while ensuring human health, safety and environmental protection, the Parties shall endeavour to cooperate and to exchange information as appropriate. 2. Areas of cooperation under this Article may include in particular: (a) the development and establishment of technical regulations or related standards; (b) the exchange, to the extent possible, of research, information and results linked to the development of new vehicle safety regulations or related standards, advanced emission reduction, and emerging vehicle technologies; (c) the exchange of available information on the identification of safety-related or emission-related defects and non-compliance with technical regulations; and (d) the promotion of greater international harmonisation of technical requirements through multilateral fora, such as the 1958 Agreement and the 1998 Agreement, including through cooperation in the planning of initiatives in support of such harmonisation. Article 9 Working Group on Motor Vehicles and Parts 1. A Working Group on Motor Vehicles and Parts shall assist the Trade Specialised Committee on Technical Barriers to Trade in monitoring and reviewing the implementation of this Annex and ensuring its proper functioning. 2. The functions of the Working Group on Motor Vehicles and Parts shall be the following: (a) discussing any matter arising under this Annex, on request of a Party; (b) facilitating cooperation and exchange of information in accordance with Article 8; (c) carrying out technical discussions in accordance with Article 97 of this Agreement on matters falling within the scope of this Annex; and (d) maintaining a list of contact points responsible for matters arising under this Annex. (1) ECE/TRANS/WP.29/78/Rev.6 of 11 July 2017. ANNEX 12 MEDICINAL PRODUCTS Article 1 Definitions For the purposes of this Annex, the following definitions apply: (a) "authority" means an authority of a Party as listed in Appendix 12-A; (b) "Good Manufacturing Practice" or "GMP" means that part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications, as listed in Appendix 12-B; (c) "inspection" means an evaluation of a manufacturing facility to determine whether such manufacturing facility is operating in compliance with Good Manufacturing Practice and/or commitments made as part of the approval to market a product, which is conducted in accordance with the laws, regulations and administrative provisions of the relevant Party, and includes pre-marketing and post-marketing inspection; (d) "official GMP document" means a document issued by an authority of a Party following the inspection of a manufacturing facility, including, for example, inspection reports, certificates attesting the compliance of a manufacturing facility with GMP, or a GMP non-compliance statement. Article 2 Scope The provisions of this Annex apply to medicinal products as listed in Appendix 12-C. Article 3 Objectives With regard to the products covered, the objectives of this Annex are: (a) to facilitate the availability of medicines in each Party’s territory; (b) to set out the conditions for the recognition of inspections and for the exchange and acceptance of official GMP documents between the Parties; (c) to promote public health by safeguarding patient safety and animal health and welfare, as well as to protect high levels of consumer and environmental protection, where relevant, by promoting regulatory approaches in line with the relevant international standards. Article 4 International standards The relevant standards for the products covered by this Annex shall ensure a high level of protection of public health in line with standards, practices and guidelines developed by the World Health Organization (WHO), the Organization for Economic Cooperation and Development (OECD), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). Article 5 Recognition of inspections and acceptance of official GMP documents 1. A Party shall recognise inspections carried out by the other Party and shall accept official GMP documents issued by the other Party in accordance with the laws, regulations and technical guidelines listed in Appendix 12-B. 2. An authority of a Party may in specific circumstances opt not to accept an official GMP document issued by an authority of the other Party for manufacturing facilities located in the territory of the issuing authority. Examples of such circumstances include the indication of material inconsistencies or inadequacies in an inspection report, quality defects identified in post-market surveillance or other specific evidence of serious concern in relation to product quality or patient safety. Each Party shall ensure that where an authority of a Party opts not to accept an official GMP document issued by an authority of the other Party, that authority notifies the relevant authority of the other Party of the reasons for not accepting the document and may request clarification from the authority of the other Party. The relevant Party shall ensure that its authority endeavours to respond to the request for clarification in a timely manner. 3. A Party may accept official GMP documents issued by an authority of the other Party for manufacturing facilities located outside the territory of the issuing authority. 4. Each Party may determine the terms and conditions under which it accepts official GMP documents issued under paragraph 3. Article 6 Exchange of official GMP documents 1. Each Party shall ensure that if an authority of a Party requests an official GMP document from the authority of the other Party, the authority of the other Party shall endeavour to transmit the document within 30 calendar days of the date of the request. 2. Each Party shall treat the information in a document obtained pursuant to paragraph 1 as confidential. Article 7 Safeguards 1. Each Party has the right to conduct its own inspection of manufacturing facilities that have been certified as compliant by the other Party. 2. Each Party shall ensure that, prior to conducting an inspection under paragraph 1, the authority of the Party that intends to conduct the inspection notifies the relevant authority of the other Party of the inspection in writing, stating the reasons for conducting its own inspection. The authority of the Party that intends to conduct the inspection shall endeavour to notify the authority of the other Party in writing at least 30 days before a proposed inspection, but may provide a shorter notice in urgent situations. The authority of the other Party may join the inspection. Article 8 Changes to applicable laws and regulations 1. Each Party shall notify the other Party at least 60 days before adopting any new measures or changes relating to Good Manufacturing Practice concerning any of the relevant laws, regulations and technical guidelines listed in Appendix 12-B. 2. The Parties shall exchange all the necessary information, including changes to their respective laws, regulations, technical guidelines or inspection procedures relating to Good Manufacturing Practice so that each Party can consider whether the conditions for the recognition of inspections and acceptance of official GMP documents pursuant to Article 5(1) continue to exist. 3. If as a result of any of the new measures or changes referred to in paragraph 1 of this Article, a Party considers that it can no longer recognise inspections or accept official GMP documents issued by the other Party, it shall notify the other Party of its intention to apply Article 9 and the Parties shall enter into consultations within the Working Group on Medicinal Products. 4. Any notification under this Article shall be done via the designated contact points in the Working Group on Medicinal Products. Article 9 Suspension 1. Without prejudice to Article 5(2), each Party has the right to suspend totally or partially the recognition of inspections and acceptance of official GMP documents of the other Party pursuant to Article 5(1) for all or some of the products listed in Appendix 12-C. That right shall be exercised in an objective and reasoned manner. The Party exercising such right shall notify the other Party and provide a written justification. A Party shall continue to accept official GMP documents of the other Party issued prior to such suspension, unless the Party decides otherwise on the basis of health or safety considerations. 2. Where, following consultations referred to in Article 8(3), a Party nevertheless suspends the recognition of inspections and acceptance of official GMP documents pursuant to Article 5(1), it may do so in accordance with paragraph 1 of this Article not earlier than 60 days after the commencement of the consultations. During that 60-day period, both Parties shall continue to recognise inspections and accept official GMP documents issued by an authority of the other Party. 3. Where recognition of inspections and acceptance of official GMP documents pursuant to Article 5(1) is suspended, at the request of a Party, the Parties shall discuss the matter within the Working Group on Medicinal Products and they shall make every effort to consider possible measures that would enable the recognition of inspections and acceptance of official GMP documents to be restored. Article 10 Regulatory cooperation 1. The Parties shall endeavour to consult one another, as permitted by their respective law, on proposals to introduce significant changes to technical regulations or inspection procedures, including those that affect how documents from the other Party are recognised in accordance with Article 5 and, where appropriate, to provide the opportunity to comment on such proposals, without prejudice to Article 8. 2. The Parties shall endeavour to cooperate with a view to strengthening, developing and promoting the adoption and implementation of internationally agreed scientific or technical guidelines including, where feasible, through the presentation of joint initiatives, proposals and approaches in the relevant international organisations and bodies referred to in Article 4. Article 11 Amendments to appendices The Partnership Council shall have the power to amend Appendix 12-A in order to update the list of authorities, Appendix 12-B in order to update the list of applicable laws, regulations and technical guidelines, and Appendix 12-C in order to update the list of covered products. Article 12 Working Group on Medicinal Products 1. The Working Group on Medicinal Products shall assist the Trade Specialised Committee on Technical Barriers to Trade in monitoring and reviewing the implementation of this Annex and ensuring its proper functioning. 2. The functions of the Working Group on Medicinal Products shall be the following: (a) discussing any matter arising under this Annex at the request of a Party; (b) facilitating cooperation and exchanges of information for the purposes of Articles 8 and 10; (c) functioning as the forum for consultations and discussions for the purposes of Articles 8(3) and 9(3); (d) carrying out technical discussions in accordance with Article 97 of this Agreement on matters falling within the scope of this Annex; and (e) maintaining a list of contact points responsible for matters arising under this Annex. Article 13 Non-application of dispute settlement Title I of Part Six of this Agreement does not apply in respect of disputes regarding the interpretation and application of this Annex. Appendix 12-A AUTHORITIES OF THE PARTIES (1) European Union: Country For medicinal products for human use For medicinal products for veterinary use Belgium Federal agency for medicines and health products / Federaal Agentschap voor geneesmiddelen en gezondheidsproducten/ Agence fédérale des médicaments et produits de santé See authority for medicinal products for human use Bulgaria Bulgarian Drug Agency / ИЗПЪЛНИТЕЛНА АГЕНЦИЯ ПО ЛЕКАРСТВАТА Bulgarian Food Safety Agency / Българска агенция по безопасност на храните Czechia State Institute for Drug Control / Státní ústav pro kontrolu léčiv (SÚKL) Institute for State Control of Veterinary Biologicals and Medicaments / Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (ÚSKVBL) Denmark Danish Medicines Agency / Laegemiddelstyrelsen See authority for medicinal products for human use Germany Federal Institute for Drugs and Medical Devices / Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Paul-Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines / Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel Federal Ministry of Health / Bundesministerium für Gesundheit (BMG) / Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) (1) Federal Office for Consumer Protection and Food Safety / Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) Federal Ministry of Food and Agriculture, Bundesministerium für Ernährung und Landwirtschaft Paul-Ehrlich-Institute (PEI), Federal Institute for Vaccines and Biomedicines / Paul-Ehrlich-Institut (PEI) Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel Estonia State Agency of Medicines / Ravimiamet See authority for medicinal products for human use Ireland Health Products Regulatory Authority (HPRA) See authority for medicinal products for human use Greece National Organisation for Medicines / Ethnikos Organismos Farmakon (EOF) - (ΕΘΝIΚΟΣ ΟΡΓΑΝIΣΜΟΣ ΦΑΡΜΑΚΩΝ) See authority for medicinal products for human use Spain Spanish Agency of Medicines and Medical Devices / Agencia Española de Medicamentos y Productos Sanitarios (2) See authority for medicinal products for human use France French National Agency for Medicines and Health Products Safety Agence nationale de sécurité du médicament et des produits de santé (ANSM) French agency for food, environmental and occupational health safety-National Agency for Veterinary Medicinal Products / Agence Nationale de Sécurité Sanitaire de l’alimentation, de l’environnement et du travail-Agence Nationale du Médicament Vétérinaire (Anses-ANMV) Croatia Agency for Medicinal Products and Medical Devices / Agencija za lijekove i medicinske proizvode (HALMED) Ministry of Agriculture, Veterinary and Food Safety Directorate / Ministarstvo Poljoprivrede, Uprava za veterinarstvo i sigurnost hrane Italy Italian Medicines Agency / Agenzia Italiana del Farmaco Direction General for Animal Health and Veterinary Medicinal Products / Ministero della Salute, Direzione Generale della Sanità Animale e dei Farmaci Veterinari Cyprus Ministry of Health - Pharmaceutical Services / Φαρμακευτικές Υπηρεσίες, Υπουργείο Υγείας Ministry of Agriculture, Rural Development and Environment- Veterinary Services / Κτηνιατρικές Υπηρεσίες- Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος Latvia State Agency of Medicines / Zāļu valsts aģentūra Assessment and Registration Department of the Food and Veterinary Service / Pārtikas un veterinārā dienesta Novērtēšanas un reģistrācijas departaments Lithuania State Medicines Control Agency / Valstybinė vaistų kontrolės tarnyba State Food and Veterinary Service / Valstybinė maisto ir veterinarijos tarnyba Luxembourg Minìstere de la Santé, Division de la Pharmacie et des Médicaments See authority for medicinal products for human use Hungary Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet / National Institute of Pharmacy and Nutrition National Food Chain Safety Office, Directorate of Veterinary Medicinal Products / Nemzeti Élelmiszerlánc-biztonsági Hivatal, Állatgyógyászati Termékek Igazgatósága (ÁTI) Malta Medicines Regulatory Authority Veterinary Medicines Section of the National Veterinary Laboratory (NVL) within The Animal Health and Welfare Department (AHWD) Netherlands Healthcare and Youth Inspectorate / Inspectie Gezondheidszorg en Youth (IGJ) Medicines Evaluation Board / Bureau Diergeneesmiddelen, College ter Beoordeling van Geneesmiddelen (CBG) Austria Austrian Agency for Health and Food Safety / Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH See authority for medicinal products for human use Poland The Main Pharmaceutical Inspectorate / Główny Inspektorat Farmaceutyczny (GIF) See authority medicinal products for human use Portugal National Authority of Medicines and Health Products / INFARMED, I.P Autoridade Nacional do Medicamento e Produtos de Saúde, I.P General Directorate of Food and Veterinary / DGAV - Direção Geral de Alimentação e Veterinária (PT) Romania National Agency for Medicines and Medical Devices / Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale National Sanitary Veterinary and Food Safety Authority / Autoritatea Naţională Sanitară Veterinară şi pentru Siguranţa Alimentelor Slovenia Agency for Medicinal Products and Medical Devices of the Republic of Slovenia / Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP) See authority for medicinal products for human use Slovakia State Institute for Drug Control / Štátny ústav pre kontrolu liečiv (ŠÚKL) Institute for State Control of Veterinary Biologicals and Medicaments / Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (ÚŠKVBL) Finland Finnish Medicines Agency / Lääkealan turvallisuus- ja kehittämiskeskus (FIMEA) See authority for medicinal products for human use Sweden Medical Products Agency / Läkemedelsverket See authority for medicinal products for human use (2) United Kingdom Medicines and Healthcare Products Regulatory Agency Veterinary Medicines Directorate Appendix 12-B LIST OF APPLICABLE LAWS, REGULATIONS AND TECHNICAL GUIDELINES RELATING TO GOOD MANUFACTURING PRACTICE (1) For the European Union: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3); Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (4); Directive 2001/20/EC of European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (5); Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (6); Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (7); Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (8); Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (9); Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (10); Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (11); Commission Delegated Regulation (EU) 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (12); Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (13); Current version of the Guide to good manufacturing practice contained in volume IV of Rules governing medicinal products in the European Union and compilation of the community procedures on inspections and exchange of information. (2) For the United Kingdom: The Human Medicines Regulations 2012 (SI 2012/1916) The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) The Veterinary Medicines Regulations 2013 (SI 2013/2033) Regulations on good manufacturing practice made under regulation B17, and guidelines on good manufacturing practice published pursuant to regulation C17, of the Human Medicines Regulations 2012 The principles and guidelines on good manufacturing practice applicable for the purposes of Schedule 2 to the Veterinary Medicines Regulations 2013 Appendix 12-C COVERED PRODUCTS Medicinal products for human use and veterinary use: — marketed medicinal products for human or veterinary use, including marketed biological and immunological products for human and veterinary use, — advanced therapy medicinal products, — active pharmaceutical ingredients for human or veterinary use, — investigational medicinal products. (1) For the purpose of this Annex, and without prejudice to the internal division of competence in Germany on matters falling within the scope of this Annex, ZLG shall be understood as covering all the competent Länder authorities issuing GMP documents and conducting pharmaceutical inspections. (2) For the purpose of this Annex, and without prejudice to the internal division of competence in Spain on matters falling within the scope of this Annex, Agencia Española de Medicamentos y Productos Sanitarios shall be understood as covering all the competent regional authorities issuing official GMP documents and conducting pharmaceutical inspections. (3) OJ EU L 311, 28.11.2001, p. 67. (4) OJ EU L 311, 28.11.2001, p. 1. (5) OJ EU L 121, 1.5.2001, p. 34. (6) OJ EU L 158, 27.5.2014, p. 1. (7) OJ EU L 136, 30.4.2004, p. 1. (8) OJ EU L 324, 10.12.2007, p. 121. (9) OJ EU L 262, 14.10.2003, p. 22. (10) OJ EU L 228, 17.8.1991, p. 70. (11) OJ EU L 238, 16.9.2017, p. 44. (12) OJ EU L 337, 25.11.2014, p. 1. (13) OJ EU L 238, 16.9.2017, p. 12. ANNEX 13 CHEMICALS Article 1 Definitions For the purposes of this Annex, the following definitions apply: (a) "responsible authorities" means: (i) for the Union: the European Commission; (ii) for the United Kingdom: the government of the United Kingdom; (b) "UN GHS" means the United Nations Globally Harmonized System of Classification and Labelling of Chemicals. Article 2 Scope This Annex applies to the trade, regulation, import and export of chemicals between the Union and the United Kingdom in respect of their registration, evaluation, authorisation, restriction, approval, classification, labelling and packaging. Article 3 Objectives 1. The objectives of this Annex are to: (a) facilitate the trade of chemicals and related products between the Parties; (b) ensure high levels of protection for the environment, and human and animal health; and (c) provide for cooperation between Union and United Kingdom responsible authorities. 2. The Parties acknowledge that the commitments made under this Annex do not prevent either Party from setting its own priorities on chemicals regulation, including establishing its own levels of protection in respect of the environment, and human and animal health. Article 4 Relevant international organisations and bodies The Parties recognise that international organisations and bodies, in particular the OECD and the Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (SCEGHS) of the United Nations Economic and Social Council (ECOSOC), are relevant for developing scientific and technical guidelines with respect to chemicals. Article 5 Participation in relevant international organisations and bodies and regulatory developments 1. The Parties shall actively contribute to the development of the scientific or technical guidelines referred to in Article 4 with respect to the assessment of hazards and risks of chemicals and the formats for documenting the results of such assessments. 2. Each Party shall implement any guidelines issued by the international organisations and bodies referred to in Article 4, unless those guidelines would be ineffective or inappropriate for the achievement of that Party’s legitimate objectives. Article 6 Classification and labelling of chemicals 1. Each Party shall implement the UN GHS as comprehensively as it considers feasible within its respective system, including for chemicals that are not within the scope of this Annex, except where there are specific reasons to apply a different labelling system for particular chemical products in their finished state intended for the final user. Each Party shall periodically update its implementation based on the regularly issued revisions of the UN GHS. 2. Where the responsible authority of a Party intends to classify individual substances in accordance with its respective rules and procedures, it shall give the responsible authority of the other Party the possibility of expressing its views in accordance with those respective rules and procedures within the applicable timelines. 3. Each Party shall make information about its procedures related to the classification of substances publicly available in accordance with its respective rules and procedures. Each Party shall endeavour to respond to comments received from the other Party pursuant to paragraph 2. 4. Nothing in this Article shall oblige either Party to achieve any particular outcome regarding the implementation of the UN GHS in its territory or regarding the classification of a given substance, or to advance, suspend or delay its respective procedures and decision-making processes. Article 7 Cooperation 1. The Parties recognise that voluntary cooperation on chemicals regulation can facilitate trade in ways that benefit consumers, businesses and the environment and that contribute to enhancing the protection of human and animal health. 2. The Parties commit to facilitating the exchange of non-confidential information between their responsible authorities, including through cooperation on electronic formats and tools used to store data. 3. The Parties shall cooperate where appropriate with a view to strengthening, developing and promoting the adoption and implementation of internationally agreed scientific or technical guidelines, including, where feasible, through the presentation of joint initiatives, proposals and approaches in the relevant international organisations and bodies, in particular those referred to in Article 4. 4. The Parties shall cooperate, if considered beneficial by both Parties, with regard to the dissemination of data related to chemicals safety, and shall make such information available to the public with the objective of ensuring easy access to and the comprehensibility of that information by different target groups. Upon request of either Party, the other Party shall provide available non-confidential information on chemicals safety to the requesting Party. 5. If a Party so requests and the other Party agrees to do so, the Parties shall enter into consultations on scientific information and data in the context of new and emerging issues related to the hazards or risks posed by chemicals to human health or the environment, with a view to creating a common pool of knowledge and, if feasible and to the extent possible, promoting a common understanding of the science related to such issues. Article 8 Information exchange The Parties shall cooperate and exchange information with respect to any issue relevant for the implementation of this Annex within the Trade Specialised Committee on Technical Barriers to Trade. ANNEX 14 ORGANIC PRODUCTS Article 1 Objective and scope 1. The objective of this Annex is to set out the provisions and procedures for fostering trade in organic products in accordance with the principles of non-discrimination and reciprocity, by means of the recognition of equivalence by the Parties of their respective laws. 2. This Annex applies to the organic products listed in Appendices 14-A and 14-B which comply with the laws and regulations listed in Appendix 14-C or 14-D. The Partnership Council shall have the power to amend Appendices 14-A, 14-B, 14-C and 14-D. Article 2 Definitions For the purposes of this Annex, the following definitions apply: (a) "competent authority" means an official agency that has jurisdiction over the laws and regulations listed in Appendix 14-C or 14-D and is responsible for the implementation of this Annex; (b) "control authority" means an authority on which the competent authority has conferred, in whole or in part, its competence for inspections and certifications in the field of organic production in accordance with the laws and regulations listed in Appendix 14-C or 14-D; (c) "control body" means an entity recognised by the competent authority to carry out inspections and certifications in the field of organic production in accordance with the laws and regulations listed in Appendix 14-C or 14-D; and (d) "equivalence" means the capability of different laws, regulations and requirements, as well as inspection and certification systems, of meeting the same objectives. Article 3 Recognition of equivalence 1. With respect to products listed in Appendix 14-A, the Union shall recognise the laws and regulations of the United Kingdom listed in Appendix 14-C as equivalent to the Union's laws and regulations listed in Appendix 14-D. 2. With respect to products listed in Appendix 14-B, the United Kingdom shall recognise the laws and regulations of the Union listed in Appendix 14-D as equivalent to the United Kingdom's laws and regulations listed in Appendix 14-C. 3. In view of the date of application of 1 January 2022 of Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007, the recognition of equivalence referred to in paragraphs 1 and 2 shall be reassessed by each Party by 31 December 2023. If, as a result of that reassessment, equivalence is not confirmed by a Party, recognition of equivalence shall be suspended. 4. Without prejudice to paragraph 3, in the event of the modification, revocation or replacement of the laws and regulations listed in Appendix 14-C or 14-D, the new rules shall be considered equivalent to the other Party’s rules unless a Party objects in accordance with the procedure set out in paragraphs 5 and 6. 5. If, following the receipt of further information from the other Party that it has requested, a Party considers that the laws, regulations or administrative procedures or practices of the other Party no longer meet the requirements for equivalence, that Party shall issue a reasoned request to the other Party to amend the relevant laws, regulations or administrative procedures or practices, and shall provide the other Party with an adequate period, which shall not be less than three months, for ensuring equivalence. 6. If, following the expiry of the period in paragraph 5, the Party concerned still considers that the requirements for equivalence are not met, it may take a decision to unilaterally suspend the recognition of equivalence of the relevant laws and regulations listed in Appendix 14-C or 14-D, as regards the relevant organic products listed in Appendix 14-A or 14-B. 7. A decision to unilaterally suspend the recognition of equivalence of the laws and regulations listed in Appendix 14-C or 14-D, as regards the relevant organic products listed in Appendix 14-A or 14-B may also be taken, following the expiry of a notice period of three months, where a Party has not provided the information required under Article 6 or does not agree to a peer review under Article 7. 8. Where recognition of equivalence is suspended in accordance with this Article, the Parties shall, at the request of a Party, discuss the matter within the Working Group on Organic Products and they shall make every effort to consider possible measures that would enable recognition of equivalence to be restored. 9. With respect to products not listed in Appendix 14-A or 14-B, equivalence shall be discussed by the Working Group on Organic Products at the request of a Party. Article 4 Import and placing on the market 1. The Union shall accept the import into its territory of the products listed in Appendix 14-A, and the placing of those products on the market as organic products, provided that those products comply with the laws and regulations of the United Kingdom listed in Appendix 14-C and are accompanied by a certificate of inspection issued by a control body recognised by the United Kingdom and indicated to the Union as referred to in paragraph 3. 2. The United Kingdom shall accept the import into its territory of the products listed in Appendix 14-B, and the placing of those products on the market as organic products, provided that those products comply with the laws and regulations of the Union listed in Appendix 14-D and are accompanied by a certificate of inspection issued by a control body recognised by the Union and indicated to the United Kingdom as referred to in paragraph 3. 3. Each Party recognises the control authorities or control bodies indicated by the other Party as responsible for performing the relevant controls as regards organic products covered by the recognition of equivalence as referred to in Article 3 and for issuing the certificate of inspection as referred to in paragraphs 1 and 2 of this Article with a view to their import into and placing on the market in the territory of the other Party. 4. The importing Party, in cooperation with the other Party, shall assign code numbers to each relevant control authority and control body indicated by the other Party. Article 5 Labelling 1. Products imported into the territory of a Party in accordance with this Annex shall meet the requirements for labelling set out in the laws and regulations of the importing Party listed in Appendices 14-C and 14-D. Those products may bear the Union’s organic logo, any United Kingdom organic logo or both logos, as set out in the relevant laws and regulations, provided that those products comply with the labelling requirements for the respective logo or both logos. 2. The Parties undertake to avoid any misuse of the terms referring to organic production in relation to organic products that are covered by the recognition of equivalence under this Annex. 3. The Parties undertake to protect the Union’s organic logo and any United Kingdom organic logo set out in the relevant laws and regulations against any misuse or imitation. The Parties shall ensure that the Union’s organic logo and any United Kingdom organic logo are used only for the labelling, advertising or commercial documents of organic products that comply with the laws and regulations listed in Appendices 14-C and 14-D. Article 6 Exchange of information 1. The Parties shall exchange all relevant information with respect to the implementation and application of this Annex. In particular, by 31 March of the second year following the entry into force of this Agreement, and by 31 March of each following year, each Party shall send to the other: (a) a report that contains information with respect to the types and quantities of organic products exported under this Annex, covering the period from January to December of the previous year; (b) a report on the monitoring and supervisory activities carried out by its competent authorities, the results obtained, and the corrective measures taken, covering the period from January to December of the previous year; and (c) details of observed irregularities and infringements of the laws and regulations listed in Appendix 14-C or 14-D, as relevant. 2. Each Party shall inform the other Party without delay of: (a) any update to the list of its competent authorities, control authorities and control bodies, including the relevant contact details (in particular the address and the internet address); (b) any changes or repeals it intends to make in respect of laws or regulations listed in Appendix 14-C or Appendix 14-D, any proposals for new laws or regulations or any relevant proposed changes to administrative procedures and practices related to organic products covered by this Annex; and (c) any changes or repeals it has adopted in respect of laws or regulations listed in Appendix 14-C or Appendix 14-D, any new legislation or relevant changes to administrative procedures and practices related to organic products covered by this Annex. Article 7 Peer reviews 1. Following advance notice of at least six months, each Party shall permit officials or experts designated by the other Party to conduct peer reviews in its territory to verify that the relevant control authorities and control bodies are carrying out the controls required to implement this Annex. 2. Each Party shall cooperate with and assist the other Party, to the extent permitted under the applicable law, in carrying out the peer reviews referred to in paragraph 1, which may include visits to offices of relevant control authorities and control bodies, processing facilities and certified operators. Article 8 Working Group on Organic Products 1. The Working Group on Organic Products shall assist the Trade Specialised Committee on Technical Barriers to Trade in monitoring and reviewing the implementation of this Annex and ensuring its proper functioning. 2. The functions of the Working Group on Organic Products shall be the following: (a) discussing any matter arising under this Annex at the request of a Party, including any possible need for amendments to this Annex or any of its Appendices; (b) facilitating cooperation regarding laws, regulations, standards and procedures concerning the organic products covered by this Annex, including discussions on any technical or regulatory issue related to rules and control systems; and (c) carrying out technical discussions in accordance with Article 97 of this Agreement on matters falling within the scope of this Annex. Appendix 14-A ORGANIC PRODUCTS FROM THE UNITED KINGDOM FOR WHICH THE UNION RECOGNISES EQUIVALENCE Description Comments Unprocessed plant products Live animals or unprocessed animal products Includes Honey Aquaculture products and seaweeds Processed agricultural products for use as food Processed agricultural products for use as feed Seeds and propagating material The organic products listed in this Appendix shall be unprocessed agricultural or aquaculture products produced in the United Kingdom or processed agricultural products for use as food or feed that have been processed in the United Kingdom with ingredients that have been grown in the United Kingdom or that have been imported into the United Kingdom in accordance with United Kingdom laws and regulations. Appendix 14-B ORGANIC PRODUCTS FROM THE UNION FOR WHICH THE UNITED KINGDOM RECOGNISES EQUIVALENCE Description Comments Unprocessed plant products Live animals or unprocessed animal products Includes Honey Aquaculture products and seaweeds Processed agricultural products for use as food Processed agricultural products for use as feed Seeds and propagating material The organic products listed in this Appendix shall be unprocessed agricultural or aquaculture products produced in the Union or processed agricultural products for use as food or feed that have been processed in the Union with ingredients that have been grown in the Union or that have been imported into the Union in accordance with the Union laws and regulations. Appendix 14-C LAWS AND REGULATIONS ON ORGANIC PRODUCTS APPLICABLE IN THE UNITED KINGDOM (1) The following laws and regulations are applicable in the United Kingdom: 1. Retained Regulation (EC) No 834/2007 2. Retained Regulation (EC) No 889/2008 3. Retained Regulation (EC) No 1235/2008 4. The Organic Products Regulations 2009 (SI 2009/842) Appendix 14-D LAWS AND REGULATIONS ON ORGANIC PRODUCTS APPLICABLE IN THE UNION The following laws and regulations are applicable in the Union: 1. Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (2) 2. Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control (3) 3. Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries (4) (1) References in this list to Retained Union law are deemed to be references to such legislation, as amended by the United Kingdom to apply to the United Kingdom. (2) OJ EU L 189, 20.7.2007, p. 1. (3) OJ EU L 250, 18.9.2008, p. 1. (4) OJ EU L 334, 12.12.2008, p. 25. ANNEX 15 TRADE IN WINE Article 1 Scope and definitions 1. This Annex applies to wine falling under heading 22.04 of the Harmonised System. 2. For the purposes of this Annex, "wine produced in" means fresh grapes, grape must and grape must in fermentation that have been turned into wine or added to wine in the territory of the exporting Party. Article 2 Product definitions, oenological practices and processes 1. Oenological practices for wine recommended and published by the International Organisation of the Vine and Wine ("OIV") shall be considered relevant international standards for the purposes of this Annex. 2. Each Party shall authorise the importation and sale for consumption of wine produced in the other Party, if that wine has been produced in accordance with: (a) product definitions authorised in each Party under the laws and regulations referred to in Appendix 15-A; (b) the oenological practices established in each Party under the laws and regulations referred to in Appendix 15-A that are in accordance with the relevant OIV standards; and (c) oenological practices and restrictions established in each Party that are not in accordance with the relevant OIV standards, listed in Appendix 15-B. 3. The Partnership Council shall have the power to amend the Appendices referred to in paragraph 2. Article 3 Certification requirements on import in the respective territories of the Parties 1. For wine produced in a Party and placed on the market in the other Party, the documentation and certification that may be required by either Party shall be limited to a certificate, as set out in Appendix 15-C, authenticated in conformity with the exporting Party’s laws and regulations. 2. A certificate required under paragraph 1 may take the form of an electronic document. Access to the electronic document or to the data necessary for its establishment shall be given by each Party on request of the competent authorities of the other Party where the goods are to be released into free circulation. If access to the relevant electronic systems is not available, the necessary data may also be requested in the form of a paper document. 3. The Partnership Council shall have the power to amend Appendix 15-C. 4. The methods of analysis recognised as reference methods by the OIV and published by the OIV shall be the reference methods for the determination of the analytical composition of the wine in the context of control operations. Article 4 Food information and lot codes 1. Unless otherwise specified in this Article, labelling of wine imported and marketed under this Agreement shall be conducted in compliance with the laws and regulations that apply in the territory of the importing Party. 2. A Party shall not require any of the following dates or their equivalent to appear on the container, label, or packaging of wine: (a) the date of packaging; (b) the date of bottling; (c) the date of production or manufacture; (d) the date of expiration, use by date, use or consume by date, expire by date; (e) the date of minimum durability, best-by-date, best quality before date; or (f) the sell-by-date. By way of derogation from point (e) of the first subparagraph, a Party may require the display of a date of minimum durability on products that on account of the addition of perishable ingredients could have a shorter date of minimum durability than would normally be expected by the consumer. 3. Each Party shall ensure that a code is indicated on the label of packaged products that allows for the identification of the lot to which the product belongs, in accordance with the legislation of the Party exporting the packaged product. The lot code shall be easily visible, clearly legible and indelible. A Party shall not allow the marketing of packaged products which do not comply with the requirements set out in this paragraph. 4. Each Party shall permit mandatory information, including translations or an indication of the number of standard drinks or alcohol units whenever required, to be displayed on a supplementary label affixed to a wine container. Supplementary labels may be affixed to a wine container after importation but prior to the product being placed on the market in the Party's territory, provided that the mandatory information is fully and accurately displayed. 5. The importing Party shall not require the display on the label of allergens which have been used in the production of wine but are not present in the final product. Article 5 Transitional measures Wine which, at the date of entry into force of this Agreement, has been produced, described and labelled in accordance with the laws and regulations of a Party but in a manner that does not comply with this Annex, may continue to be labelled and placed on the market as follows: (a) by wholesalers or producers, for a period of two years from the entry into force of this Agreement; and (b) by retailers, until stocks are exhausted. Article 6 Information exchange The Parties shall cooperate and exchange information on any issue relevant for the implementation of this Annex within the Trade Specialised Committee on Technical Barriers to Trade. Article 7 Review No later than three years from the entry into force of this Agreement, the Parties shall consider further steps to facilitate trade in wine between the Parties. Appendix 15-A LAWS AND REGULATIONS OF THE PARTIES Laws and regulations of the United Kingdom (1) Laws and regulations referred to in Article 2(2) concerning: a) product definitions: (i) Retained Regulation (EU) No 1308/2013, in particular production rules in the wine sector, in accordance with Articles 75, 81 and 91, Part IV of Annex II and Part II of Annex VII to that Regulation and its implementing rules, including subsequent modifications; (ii) Retained Commission Delegated Regulation (EU) 2019/33, in particular Articles 47, 52 to 54 and Annexes III, V and VI to that Regulation, including subsequent modifications; (iii) Retained Regulation (EU) No 1169/2011, including subsequent modifications; b) oenological practices and restrictions: (i) Retained Regulation (EU) No 1308/2013, in particular oenological practices and restrictions in accordance with Articles 80 and 83 and Annex VIII to that Regulation and its implementing rules, including subsequent modifications; (ii) Retained Commission Delegated Regulation (EU) 2019/934, including subsequent modifications. Laws and regulations of the Union: Laws and regulations referred to in Article 2(2) concerning: a) product definitions: (i) Regulation (EU) No 1308/2013 of the European Parliament and of the Council (2), in particular production rules in the wine sector, in accordance with Articles 75, 81 and 91, Part IV of Annex II and Part II of Annex VII to that Regulation and its implementing rules, including subsequent modifications; (ii) Commission Delegated Regulation (EU) 2019/33 (3), in particular Articles 47, 52 to 54 and Annexes III, V and VI to that Regulation, including subsequent modifications; (iii) Regulation (EU) No 1169/2011 of the European Parliament and of the Council (4), including subsequent modifications. b) oenological practices and restrictions: (i) Regulation (EU) No 1308/2013, in particular oenological practices and restrictions in accordance with Articles 80 and 83 and Annex VIII to that Regulation and its implementing rules, including subsequent modifications; (ii) Commission Delegated Regulation (EU) 2019/934 (5), including subsequent modifications. Appendix 15-B ADDITIONAL OENOLOGICAL PRACTICES AND RESTRICTIONS JOINTLY ACCEPTED BY THE PARTIES (1) Concentrated grape must, rectified concentrated grape must and sucrose may be used for enrichment and sweetening under the specific and limited conditions set out in Part I of Annex VIII to Regulation (EU) No 1308/2013 and in Part I of Annex VIII to Retained Regulation (EU) No 1308/2013, subject to the exclusion of use of these products in a reconstituted form in wines covered by this Agreement. (2) The addition of water in winemaking is not allowed, except where required on account of a specific technical necessity. (3) Fresh lees may be used under the specific and limited conditions set out in line item 11.2 of Table 2 of Part A of Annex I to Commission Delegated Regulation (EU) 2019/934 and in line item 11.2 of Table 2 of Part A of Annex I to Retained Commission Delegated Regulation (EU) 2019/934. Appendix 15-C TEMPLATE FOR SELF-CERTIFICATE FOR WINE IMPORTED FROM THE [EUROPEAN UNION / UNITED KINGDOM] INTO THE [UNITED KINGDOM / EUROPEAN UNION](1) 1. Exporter (name and address) 2. Serial No(2) 3. Importer (name and address) 4. Competent authority at the place of dispatch in the [European Union / United Kingdom](3) 5. Customs stamp (for official [European Union / United Kingdom] use only) 6. Means of transport and transport details(4) 7. Place of unloading (if different from 3) 8. Description of the imported product(5) 9. Quantity in l/hl/kg 10. Number of containers(6) 11. Certificate The product described above is intended for direct human consumption and complies with the definitions and oenological practices authorised under Annex 15 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part. It has been produced by a producer who is subject to inspection and supervision by the following competent authority(7): Consignor certifying the above information(8) Identification of the consignor(9) Place, date and signature of the consignor (1) In accordance with Article 3(1) of Annex 15 to the Trade and Cooperation Agreement between the European Union European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part. (2) Indicate the traceability number of the consignment, i.e. a serial number that identifies the consignment in the records of the exporter. (3) Indicate full name, address and contact details of the competent authority in one of the Member States of the European Union or in the United Kingdom from which the consignment is exported that is responsible for verifying the information referred to in this certificate. (4) Indicate transport used for delivery to the point of entry into the European Union or the United Kingdom; specify transport mode (ship, airplane, etc.), give name of the means of transport (name of ship, number of flight, etc.). (5) Indicate the following information: — sale designation, as it appears on the label, — name of producer, — wine-growing region, — name of the country of production (one of the Member States of the European Union, or the United Kingdom), — name of the GI, if relevant, — total alcoholic strength by volume, — colour of the product (state "red", "rosé", "pink" or "white" only), — Combined Nomenclature code (CN code). (6) A container means a receptacle for wine of less than 60 litres. The number of containers may be the number of bottles. (7) Indicate full name, address and contact details of relevant competent authority in one of the Member States of the European Union or in the United Kingdom. (8) Indicate full name, address and contact details of the consignor. (9) Indicate: — For the European Union: the System of Exchange of Excise Data (SEED) excise number, or VAT number in case the consignor has no SEED number, or reference to the number in the list or register provided for in Article 8(3) of Commission Delegated Regulation (EU) 2018/273 (6); — For the United Kingdom: the System of Exchange of Excise Data (SEED) excise number, or VAT number in case the consignor has no SEED number, or reference to the WSB number. (1) References in this list to Retained Union law are deemed to be references to such legislation, as amended by the United Kingdom to apply to the United Kingdom. (2) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ EU L 347, 20.12.2013, p. 671). (3) Commission Delegated Regulation (EU) 2019/33 of 17 October 2018 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards applications for protection of designations of origin, geographical indications and traditional terms in the wine sector, the objection procedure, restrictions of use, amendments to product specifications, cancellation of protection, and labelling and presentation (OJ EU L 9, 11.1.2019, p. 2). (4) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ EU L 304, 22.11.2011, p. 18). (5) Commission Delegated Regulation (EU) 2019/934 of 12 March 2019 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards wine-growing areas where the alcoholic strength may be increased, authorised oenological practices and restrictions applicable to the production and conservation of grapevine products, the minimum percentage of alcohol for by-products and their disposal, and publication of OIV files (OJ EU L 149, 7.6.2019, p. 1). (6) Commission Delegated Regulation (EU) 2018/273 of 11 December 2017 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the scheme of authorisations for vine plantings, the vineyard register, accompanying documents and certification, the inward and outward register, compulsory declarations, notifications and publication of notified information, and supplementing Regulation (EU) No 1306/2013 of the European Parliament and of the Council as regards the relevant checks and penalties, amending Commission Regulations (EC) No 555/2008, (EC) No 606/2009 and (EC) No 607/2009 and repealing Commission Regulation (EC) No 436/2009 and Commission Delegated Regulation (EU) 2015/560 (OJ EU L 58, 28.2.2018, p. 1). ANNEX 16 ARRANGEMENT REFERRED TO IN ARTICLE 96(4) FOR THE REGULAR EXCHANGE OF INFORMATION IN RELATION TO THE SAFETY OF NON-FOOD PRODUCTS AND RELATED PREVENTIVE, RESTRICTIVE AND CORRECTIVE MEASURES This Annex shall establish an arrangement for the regular exchange of information between the Union’s Rapid Alert System for non-food products (RAPEX), or its successor, and the United Kingdom’s database relating to market surveillance and product safety established under the General Product Safety Regulations 2005, or its successor. In accordance with Article 96(8) of this Agreement, the arrangement shall specify the type of information to be exchanged, the modalities for the exchange and the application of confidentiality and personal data protection rules. ANNEX 17 ARRANGEMENT REFERRED TO IN ARTICLE 96(5) FOR THE REGULAR EXCHANGE OF INFORMATION REGARDING MEASURES TAKEN ON NON-COMPLIANT NON-FOOD PRODUCTS, OTHER THAN THOSE COVERED BY ARTICLE 96(4) This Annex shall establish an arrangement for the regular exchange of information, including the exchange of information by electronic means, regarding measures taken on non-compliant non-food products, other than those covered by Article 96(4) of this Agreement. In accordance with Article 96(8) of this Agreement, the arrangement shall specify the type of information to be exchanged, the modalities for the exchange and the application of confidentiality and personal data protection rules. ANNEX 18 AUTHORISED ECONOMIC OPERATORS Article 1 Criteria for and treatment of Authorised Economic Operators 1. The specified criteria for qualification as an Authorised Economic Operator ("AEO") referred to in Article 110 of this Agreement, shall be established by the Parties' laws, regulations or procedures. The specified criteria, which shall be published, shall include: (a) the absence of any serious infringement or repeated infringements of customs legislation and taxation rules, including no record of serious criminal offences relating to the economic activity of the applicant; (b) the demonstration by the applicant of a high level of control of his or her operations and of the flow of goods, by means of a system of managing commercial and, where appropriate, transport records, which allows appropriate customs controls; (c) financial solvency which shall be deemed to be proven where the applicant has good financial standing, which enables him or her to fulfil his or her commitments, with due regard to the characteristics of the type of business activity concerned; and (d) appropriate security and safety standards which shall be considered as fulfilled where the applicant demonstrates that he or she maintains appropriate measures to ensure the security and safety of the international supply chain including in the areas of physical integrity and access controls, logistical processes and handling of specific types of goods, personnel and identification of his or her business partners. 2. The specified criteria for qualification as an AEO shall not be designed or applied so as to afford or create arbitrary or unjustifiable discrimination between operators where the same conditions prevail. Those criteria shall allow small and medium-sized enterprises to qualify as AEOs. 3. The trade partnership programme referred to in Article 110 of this Agreement shall include the following treatment: (a) taking the AEO status granted by the other Party favourably into account in its risk assessment to reduce inspections or controls and in other security and safety-related measures; (b) giving priority to the inspection of consignments covered by exit or entry summary declarations lodged by an AEO, if the customs authority decides to proceed with an inspection; (c) taking the AEO status granted by the other Party into account with a view to treating the AEO as a secure and safe partner when assessing requirements concerning business partners for applicants under its own Programme; and (d) endeavouring to establish a joint business continuity mechanism to respond to disruptions in trade flows due to increases in security alerts levels, border closures and/or natural disasters, hazardous emergencies or other major incidents where priority cargos related to AEOs could be facilitated and expedited to the extent possible by the customs authorities of the Parties. Article 2 Mutual recognition and responsibility for implementation 1. AEO Status under the trade partnership programmes of the Union and the United Kingdom are recognised to be compatible, and holders of the AEO status granted under each programme shall be treated in a manner consistent with Article 4. 2. The trade partnership programmes concerned are: a) The European Union Authorised Economic operator (security and safety) (point (b) of Article 38(2) of Regulation (EU) No 952/2013); b) The United Kingdom Authorised Economic Operator programme (security and safety) (point (b) of Article 38(2) of Regulation (EU) No 952/2013, as retained in United Kingdom domestic law). 3. The customs authorities, as defined in point (a) of Article 512 of this Agreement ("customs authorities"), are responsible for the implementation of the provisions in this Annex. Article 3 Compatibility 1. The Parties shall cooperate to maintain compatibility of the standards applied to each of their trade partnership programmes with respect to the following matters: (a) the application process for granting the AEO status to operators; (b) the assessment of AEO status applications; (c) the granting of the AEO status; and (d) the managing, monitoring, suspension and re-assessment, and revocation of the AEO status. The Parties shall ensure that their customs authorities monitor AEOs′ compliance with the relevant conditions and criteria. 2. The Parties shall complete a joint work programme setting out a minimum number of joint validations of holders of the AEO status granted under each trade partnership programme that must be completed by the end of 2021, at the latest. 3. The Parties shall ensure that their trade partnership programmes operate within the relevant standards of the SAFE Framework. Article 4 Treatment of status holders 1. Each Party shall provide comparable treatment to that given to AEOs under the other Party's trade partnership programme. This treatment shall include in particular the treatment set out in Article 1(3). 2. Each Party may suspend the treatment referred to in Article 1(3) to an AEO under the other Party's trade partnership programme under this Agreement if that AEO ceases to comply with the legal requirements. Such suspension shall be promptly communicated to the other customs authority together with any additional information regarding the basis for suspension, as appropriate. 3. Each Party shall promptly inform the other Party in cases where it identifies any irregularity committed by an AEO authorised by the other customs authority to allow it to take an informed decision on the possible revocation or suspension of the membership of the operator concerned. Article 5 Exchange of information and communication 1. The Parties shall endeavour to communicate effectively with each other in the implementation of this Agreement. They shall exchange information and foster communication regarding their trade partnership programmes, in particular by: (a) providing updates on the operation and development of their trade partnership programmes in a timely manner; (b) engaging in mutually beneficial exchanges of information regarding supply chain security; (c) designating the contact points for their respective trade partnership programmes and providing the contact details for those contact points to the other Party; and (d) facilitating effective inter-agency communication between the European Commission's Directorate-General for Taxation and Customs Union and Her Majesty's Revenue and Customs to enhance risk management practices under their respective trade partnership programmes with respect to supply chain security on the part of AEOs. 2. Information and related data shall be exchanged in a systematic manner by electronic means. 3. The data to be exchanged regarding AEOs shall include: (a) name; (b) address; (c) status of membership; (d) validation or authorisation date; (e) suspensions and revocations; (f) the unique authorisation or identification number (in a form mutually determined by the customs authorities); and (g) other details that may be mutually determined between the customs authorities, subject, where applicable, to any necessary safeguards. The exchange of data shall commence with the entry into force of this Agreement. 4. The Parties shall use their best endeavours to establish, within six months of entry into force of this Agreement, an arrangement for fully automated exchange of the data referred to in paragraph 3, and in any event shall implement such an arrangement no later than one year after the entry into force of this Agreement. Article 6 Treatment of data Any exchange of information between the Parties under this Annex shall be mutatis mutandis subject to the confidentiality and protection of information set out in Article 12 of the Protocol on mutual administrative assistance in customs matters. Article 7 Consultation and review The Trade Specialised Committee on Customs Cooperation and Rules of Origin shall review the implementation of the provisions of this Annex regularly. That review shall include: (a) joint validations of AEOs granted status by each Party to identify strengths and weaknesses in implementing this Annex; (b) exchanges of views on data to be shared and treatment of operators. Article 8 Suspension and discontinuation 1. A Party may pursue the procedure set out in paragraph 2 in the event that either of the following circumstances arise: a) Before or within three months of entry into force of this Agreement the other Party has made material changes to the legal provisions referred to in Article 2(2) that were assessed in order to establish that the trade partnership programmes are compatible, such that the compatibility required for recognition under Article 2(1) has ceased to exist. b) The provisions under Article 5(2) are not operational. 2. In the event that either of the circumstances set out in point (a) or (b) of paragraph 1 arise, a Party may suspend the recognition provided for in Article 2(1) 60 days after notifying the other Party of their intention. 3. Where a party gives notice of its intention to suspend the recognition provided for in Article 2(1) in accordance with paragraph 2 of this Article, the other Party may request consultations in the Trade Specialised Committee on Customs Cooperation and Rules of Origin. These consultations shall be held within 60 days of the request. 4. A Party may pursue the procedure set out in paragraph 5 in the event that either of the following circumstances arise: a) The other Party changes its AEO programme or its implementation of this programme such that the compatibility required for recognition under Article 2(1) has ceased to exist; b) The joint validations provided for in Article 3(2) do not confirm the compatibility of the Parties' respective AEO programmes. 5. In the event that either of the circumstances set out in point (a) or (b) of paragraph 4 arise, a Party may request consultations with the other Party in the framework of the Trade Specialised Committee on Customs Cooperation and Rules of Origin. These consultations shall be held within 60 days from the request. If 90 days after the request a Party still considers that the compatibility required for recognition under Article 2(1) has ceased to exist, it may notify the other Party of its intention to suspend recognition of its programme. Suspension shall take effect 30 days after notification. ANNEX 19 EXISTING MEASURES Headnotes 1. The Schedules of the United Kingdom and the Union set out, under Articles 133, 139 and 195 of this Agreement, the reservations taken by the United Kingdom and the Union with respect to existing measures that do not conform with obligations imposed by: (a) Article 128 or 135 of this Agreement; (b) Article 136 of this Agreement; (c) Article 129 or 137 of this Agreement; (d) Article 130 or 138 of this Agreement; (e) Article 131 of this Agreement; (f) Article 132 of this Agreement; or (g) Article 194 of this Agreement. 2. The reservations of a Party are without prejudice to the rights and obligations of the Parties under GATS. 3. Each reservation sets out the following elements: (a) "sector" refers to the general sector in which the reservation is taken; (b) "sub-sector" refers to the specific sector in which the reservation is taken; (c) "industry classification" refers, where applicable, to the activity covered by the reservation according to the CPC, ISIC Rev. 3.1, or as expressly otherwise described in that reservation; (d) "type of reservation" specifies the obligation referred to in paragraph 1 for which a reservation is taken; (e) "level of government" indicates the level of government maintaining the measure for which a reservation is taken; (f) "measures" identifies the laws or other measures as qualified, where indicated, by the "description" element for which the reservation is taken. A "measure" cited in the "measures" element: (i) means the measure as amended, continued or renewed as of the date of entry into force of this Agreement; (ii) includes any subordinate measure adopted or maintained under the authority of and consistent with the measure; and (iii) in respect of the Schedule of the Union, includes any laws or other measures which implement a directive at Member State level; and (g) "description" sets out the non-conforming aspects of the existing measure for which the reservation is taken. 4. For greater certainty, if a Party adopts a new measure at a level of government different to that at which the reservation was originally taken, and this new measure effectively replaces – within the territory to which it applies – the non-conforming aspect of the original measure cited in the "measures" element, the new measure shall be deemed to constitute "modification" to the original measure within the meaning of point (c) of Article 133(1), point (c) of Article 139(1), point (c) of Article 144 and point (c) of Article 195(1) of this Agreement. 5. In the interpretation of a reservation, all elements of the reservation shall be considered. A reservation shall be interpreted in the light of the relevant obligations of the Chapters or Sections against which the reservation is taken. The "measures" element shall prevail over all other elements. 6. For the purposes of the Schedules of the United Kingdom and the Union: (a) "ISIC Rev. 3.1" means the International Standard Industrial Classification of All Economic Activities as set out in Statistical Office of the United Nations, Statistical Papers, Series M, No.4, ISIC Rev. 3.1, 2002; (b) "CPC" means the Provisional Central Product Classification (Statistical Papers, Series M No. 77, Department of International Economic and Social Affairs, Statistical Office of the United Nations, New York, 1991). 7. For the purposes of the Schedules of the United Kingdom and the Union, a reservation for a requirement to have a local presence in the territory of the Union or the United Kingdom is taken against Article 136 of this Agreement, and not against Article 135 or 137 of this Agreement. Furthermore, such a requirement is not taken as a reservation against Article 129 of this Agreement. 8. A reservation taken at the level of the Union applies to a measure of the Union, to a measure of a Member State at the central level or to a measure of a government within a Member State, unless the reservation excludes a Member State. A reservation taken by a Member State applies to a measure of a government at the central, regional or local level within that Member State. For the purposes of the reservations of Belgium, the central level of government covers the federal government and the governments of the regions and the communities as each of them holds equipollent legislative powers. For the purposes of the reservations of the Union and its Member States, a regional level of government in Finland means the Åland Islands. A reservation taken at the level of the United Kingdom applies to a measure of the central government, a regional government or a local government. 9. The list of reservations below does not include measures relating to qualification requirements and procedures, technical standards and licensing requirements and procedures where they do not constitute a limitation within the meaning of Article 128, 129, 135, 136, 137 or 194 of this Agreement. These measures may include, in particular, the need to obtain a licence, to satisfy universal service obligations, to have recognised qualifications in regulated sectors, to pass specific examinations, including language examinations, to fulfil a membership requirement of a particular profession, such as membership in a professional organisation, to have a local agent for service, or to maintain a local address, or any other non-discriminatory requirements that certain activities may not be carried out in protected zones or areas. While not listed, such measures continue to apply. 10. For greater certainty, for the Union, the obligation to grant national treatment does not entail the requirement to extend to natural or legal persons of the United Kingdom the treatment granted in a Member State, pursuant to the Treaty on the Functioning of the European Union, or any measure adopted pursuant to that Treaty, including their implementation in the Member States, to: (i) natural persons or residents of another Member State; or (ii) legal persons constituted or organised under the law of another Member State or of the Union and having their registered office, central administration or principal place of business in the Union. 11. Treatment granted to legal persons established by investors of a Party in accordance with the law of the other Party (including, in the case of the Union, the law of a Member State) and having their registered office, central administration or principal place of business within that other Party, is without prejudice to any condition or obligation, consistent with Chapter 2 of Title II of Heading One of Part Two of this Agreement, which may have been imposed on such legal person when it was established in that other Party, and which shall continue to apply. 12. The Schedules apply only to the territories of the United Kingdom and the Union in accordance with Article 520(2) and Article 774 of this Agreement and are only relevant in the context of trade relations between the Union and its Member States with the United Kingdom. They do not affect the rights and obligations of the Member States under Union law. 13. For greater certainty, non-discriminatory measures do not constitute a market access limitation within the meaning of Article 128, 135 or 194 of this Agreement for any measure: (a) requiring the separation of the ownership of infrastructure from the ownership of the goods or services provided through that infrastructure to ensure fair competition, for example in the fields of energy, transportation and telecommunications; (b) restricting the concentration of ownership to ensure fair competition; (c) seeking to ensure the conservation and protection of natural resources and the environment, including a limitation on the availability, number and scope of concessions granted, and the imposition of a moratorium or ban; (d) limiting the number of authorisations granted because of technical or physical constraints, for example telecommunications spectra and frequencies; or (e) requiring that a certain percentage of the shareholders, owners, partners, or directors of an enterprise be qualified or practice a certain profession such as lawyers or accountants. 14. With respect to financial services: Unlike foreign subsidiaries, branches established directly in a Member State by a non-European Union financial institution are not, with certain limited exceptions, subject to prudential regulations harmonised at Union level which enable such subsidiaries to benefit from enhanced facilities to set up new establishments and to provide cross-border services throughout the Union. Therefore, such branches receive an authorisation to operate in the territory of a Member State under conditions equivalent to those applied to domestic financial institutions of that Member State, and may be required to satisfy a number of specific prudential requirements such as, in the case of banking and securities, separate capitalisation and other solvency requirements and reporting and publication of accounts requirements or, in the case of insurance, specific guarantee and deposit requirements, a separate capitalisation, and the localisation in the Member State concerned of the assets representing the technical reserves and at least one third of the solvency margin. The following abbreviations are used in the list of reservations below: UK United Kingdom EU European Union, including all its Member States AT Austria BE Belgium BG Bulgaria CY Cyprus CZ Czechia DE Germany DK Denmark EE Estonia EL Greece ES Spain FI Finland FR France HR Croatia HU Hungary IE Ireland IT Italy LT Lithuania LU Luxembourg LV Latvia MT Malta NL The Netherlands PL Poland PT Portugal RO Romania SE Sweden SI Slovenia SK Slovak Republic Schedule of the Union Reservation No. 1 - All sectors Reservation No. 2 - Professional services (except health-related professions) Reservation No. 3 - Professional services (health related and retail of pharmaceuticals) Reservation No. 4 - Research and development services Reservation No. 5 - Real estate services Reservation No. 6 - Business services Reservation No. 7 - Communication services Reservation No. 8 - Construction Services Reservation No. 9 - Distribution services Reservation No. 10 - Education services Reservation No. 11 - Environmental services Reservation No. 12 - Financial Services Reservation No. 13 - Health services and social services Reservation No. 14 - Tourism and travel related services Reservation No. 15 - Recreational, cultural and sporting services Reservation No. 16 - Transport services and services auxiliary to transport services Reservation No. 17 - Energy related activities Reservation No. 18 - Agriculture, fishing and manufacturing Reservation No. 1 - All sectors Sector: All sectors Type of reservation: Market access National treatment Most-favoured-nation treatment Performance requirements Senior management and boards of directors Obligations for legal services Chapter/Section: Investment liberalisation; Cross-border trade in services and Regulatory framework for legal services Level of government: EU/Member State (unless otherwise specified) Description: (a) Type of establishment With respect to Investment liberalisation – National treatment and Regulatory framework for legal services – Obligations: The EU: Treatment granted pursuant to the Treaty on the Functioning of the European Union to legal persons formed in accordance with the law of the Union or of a Member State and having their registered office, central administration or principal place of business within the Union, including those established in the Union by investors of the United Kingdom, is not accorded to legal persons established outside the Union, nor to branches or representative offices of such legal persons, including to branches or representative offices of legal persons of the United Kingdom. Treatment less favourable may be accorded to legal persons formed in accordance with the law of the Union or of a Member State which have only their registered office in the Union, unless it can be shown that they possess an effective and continuous link with the economy of one of the Member States. Measures: EU: Treaty on the Functioning of the European Union. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors: This reservation applies only to health, social or education services: The EU (applies also to the regional level of government): Any Member State, when selling or disposing of its equity interests in, or the assets of, an existing state enterprise or an existing governmental entity providing health, social or education services (CPC 93, 92), may prohibit or impose limitations on the ownership of such interests or assets, and/or restrict the ability of owners of such interests and assets to control any resulting enterprise, with respect to investors of the United Kingdom or their enterprises. With respect to such a sale or other disposition, any Member State may adopt or maintain any measure relating to the nationality of senior management or members of the boards of directors, as well as any measure limiting the number of suppliers. For the purposes of this reservation: (i) any measure maintained or adopted after the date of entry into force of this Agreement that, at the time of the sale or other disposition, prohibits or imposes limitations on the ownership of equity interests or assets or imposes nationality requirements or imposes limitations on the numbers of suppliers as described in this reservation shall be deemed to be an existing measure; and (ii) "state enterprise" means an enterprise owned or controlled through ownership interests by any Member State and includes an enterprise established after the date of entry into force of this Agreement solely for the purposes of selling or disposing of equity interests in, or the assets of, an existing state enterprise or governmental entity. Measures: EU: As set out in the description element as indicated above. With respect to Investment liberalisation – National Treatment and Regulatory framework for legal services – Obligations In AT: For the operation of a branch, non-European Economic Area (non-EEA) corporations must appoint at least one person responsible for its representation who is resident in Austria. Executives (managing directors, natural persons) responsible for the observance of the Austrian Trade Act (Gewerbeordnung) must be domiciled in Austria. In BG: Foreign legal persons, unless established under the legislation of a Member State of the European Economic Area (EEA), may conduct business and pursue activities if established in the Republic of Bulgaria in the form of a company registered in the Commercial Register. Establishment of branches is subject to authorisation. Representative offices of foreign enterprises are to be registered with Bulgarian Chamber of Commerce and Industry and may not engage in economic activity but are only entitled to advertise their owner and act as representatives or agents. In EE: If the residence of at least half of the members of the management board of a private limited company, a public limited company or a branch is not in Estonia, in another Member State of the EEA or in the Swiss Confederation, the private limited company, the public limited company or the foreign company shall appoint a point of contact whose Estonian address can be used for the delivery of the procedural documents of the undertaking and the declarations of intent addressed to the undertaking (i.e. the branch of a foreign company). With respect to Investment liberalisation – National treatment; Cross-border trade in services – Market access and Regulatory framework for legal services – Obligations: In FI: At least one of the partners in a general partnership or of general partners in a limited partnership needs to have residency in the EEA or, if the partner is a legal person, be domiciled (no branches allowed) in the EEA. Exemptions may be granted by the registration authority. To carry on trade as a private entrepreneur, residency in the EEA is required. If a foreign organisation from a country outside the EEA intends to carry on a business or trade by establishing a branch in Finland, a trade permit is required. Residency in the EEA is required for at least one of the ordinary and one of the deputy members of the board of directors and for the managing director. Company exemptions may be granted by the registration authority. In SE: A foreign company, which has not established a legal entity in Sweden or is conducting its business through a commercial agent, shall conduct its commercial operations through a branch, registered in Sweden, with independent management and separate accounts. The managing director and the vice-managing director, if appointed, of the branch, must reside in the EEA. A natural person not resident in the EEA, who conducts commercial operations in Sweden, shall appoint and register a resident representative responsible for the operations in Sweden. Separate accounts shall be kept for the operations in Sweden. The competent authority may in individual cases grant exemptions from the branch and residency requirements. Building projects with duration of less than a year, conducted by a company located or a natural person residing outside the EEA, are exempted from the requirements of establishing a branch or appointing a resident representative. For limited liability companies and co-operative economic associations, at least 50 per cent of the members of the board of directors, at least 50 per cent of the deputy board members, the managing director, the vice-managing director, and at least one of the persons authorised to sign for the company, if any, must reside within the EEA. The competent authority may grant exemptions from this requirement. If none of the company's or society's representatives reside in Sweden, the board must appoint and register a person resident in Sweden, who has been authorised to receive servings on behalf of the company or society. Corresponding conditions prevail for establishment of all other types of legal entities. In SK: A foreign natural person whose name is to be registered in the appropriate register (Commercial register, Entrepreneurial or other professional register) as a person authorised to act on behalf of an entrepreneur is required to submit a residence permit for Slovakia. Measures: AT: Aktiengesetz, BGBL. Nr. 98/1965, § 254 (2); GmbH-Gesetz, RGBL. Nr. 58/1906, § 107 (2); and Gewerbeordnung, BGBL. Nr. 194/1994, § 39 (2a). BG: Commercial Law, Article 17a; and Law for Encouragement of Investments, Article 24. EE: Äriseadustik (Commercial Code) § 631 (1, 2 and 4). FI: Laki elinkeinon harjoittamisen oikeudesta (Act on the Right to Carry on a Trade) (122/1919), s. 1; Osuuskuntalaki (Co-Operatives Act) 1488/2001; Osakeyhtiölaki (Limited Liabilities Company Act) (624/2006); and Laki luottolaitostoiminnasta (Act on Credit Institutions) (121/2007). SE: Lag om utländska filialer m.m (Foreign Branch Offices Act) (1992:160); Aktiebolagslagen (Companies Act) (2005:551); The Co-operative Economic Associations Act (2018:672); and Act on European Economic Interest Groupings (1994:1927). SK: Act 513/1991 on Commercial Code (Article 21); Act 455/1991 on Trade Licensing; and Act no 404/2011 on Residence of Aliens (Articles 22 and 32). With respect to Investment liberalisation – Market Access, National Treatment, Performance requirements and Regulatory framework for legal services – Obligations: In BG: Established enterprises may employ third country nationals only for positions for which there is no requirement for Bulgarian nationality. The total number of third country nationals employed by an established enterprise over a period of the preceding 12 months must not exceed 20 percent (35 percent for small and medium-sized enterprises) of the average number of Bulgarian nationals, nationals of other Member States, of states parties to the Agreement on the EEA or of the Swiss Confederation hired on an employment contract. In addition, the employer must demonstrate that there is no suitable Bulgarian, EU, EEA or Swiss worker for the respective position by conducting a labour market test before employing a third country national. For highly qualified, seasonal and posted workers, as well as for intra-corporate transferees, researchers and students there is no limitation on the number of third country nationals working for a single enterprise. For the employment of third country nationals in these categories, no labour market test is required. Measures: BG: Labour Migration and Labour Mobility Act. With respect to Investment liberalisation – Market access, National treatment: In PL: The scope of operations of a representative office may only encompass advertising and promotion of the foreign parent company represented by the office. For all sectors except legal services, establishment by non-European Union investors and their enterprises may only be in the form of a limited partnership, limited joint-stock partnership, limited liability company, and joint-stock company, while domestic investors and enterprises have access also to the forms of non-commercial partnership companies (general partnership and unlimited liability partnership). Measures: PL: Act of 6 March 2018 on rules regarding economic activity of foreign entrepreneurs and other foreign persons in the territory of the Republic of Poland. (b) Acquisition of real estate With respect to Investment liberalisation – National treatment: In AT (applies to the regional level of government): The acquisition, purchase and rental or leasing of real estate by non-European Union natural persons and enterprises requires authorisation by the competent regional authorities (Länder). Authorisation will only be granted if the acquisition is considered to be in the public (in particular economic, social and cultural) interest. In CY: Cypriots or persons of Cypriot origin, as well as nationals of a Member State, are allowed to acquire any property in Cyprus without restrictions. A foreigner shall not acquire, otherwise than mortis causa, any immovable property without obtaining a permit from the Council of Ministers. For foreigners, where the acquisition of immovable property exceeds the extent necessary for the erection of a premises for a house or professional roof, or otherwise exceeds the extent of two donums (2,676 square meter), any permit granted by the Council of Ministers shall be subject to such terms, limitations, conditions and criteria which are set by Regulations made by the Council of Ministers and approved by the House of Representatives. A foreigner is any person who is not a citizen of the Republic of Cyprus, including a foreign controlled company. The term does not include foreigners of Cypriot origin or non-Cypriot spouses of citizens of the Republic of Cyprus. In CZ: Specific rules apply to agricultural land under state ownership. State agricultural land can be acquired only by Czech nationals, nationals of another Member State, or states parties to the Agreement on the EEA or the Swiss Confederation. Legal persons can acquire state agriculture land from the state only if they are agricultural entrepreneurs in the Czech Republic or persons with similar status in other Member State of the European Union, or states parties to the Agreement on the EEA or the Swiss Confederation. In DK: Natural persons who are not resident in Denmark, and who have not previously been resident in Denmark for a total period of five years, must in accordance with the Danish Acquisition Act obtain permission from the Ministry of Justice to acquire title to real property in Denmark. This also applies for legal persons that are not registered in Denmark. For natural persons, acquisition of real property will be permitted if the applicant is going to use the real property as his or her primary residence. For legal persons that are not registered in Denmark, acquisition of real property will in general be permitted, if the acquisition is a prerequisite for the business activities of the purchaser. Permission is also required if the applicant is going to use the real property as a secondary dwelling. Such permission will only be granted if the applicant through an overall and concrete assessment is regarded to have particular strong ties to Denmark. Permission under the Acquisition Act is only granted for the acquisition of a specific real property. The acquisition of agricultural land by natural or legal persons is in addition governed by the Danish Agricultural Holdings Act, which imposes restrictions on all persons, Danish or foreign, when acquiring agricultural property. Accordingly, any natural or legal person, who wishes to acquire agricultural real property, must fulfil the requirements in this Act. This generally means a limited residence requirement on the agricultural holding applies. The residence requirement is not personal. Legal entities must be of the types listed in §20 and §21 of the act and must be registered in the Union (or EEA). In EE: A legal person from an OECD Member State has the right to acquire an immovable which contains: (i) less than ten hectares of agricultural land, forest land or agricultural and forest land in total without restrictions. (ii) ten hectares or more of agricultural land if the legal person has been engaged, for three years immediately preceding the year of making the transaction of acquisition of the immovable, in production of agricultural products listed in Annex I to the Treaty on the Functioning of the European Union, except fishery products and cotton (hereinafter agricultural product). (iii) ten hectares or more of forest land if the legal person has been engaged, for three years immediately preceding the year of making the transaction of acquisition of the immovable, in forest management within the meaning of the Forest Act (hereinafter forest management) or production of agricultural products. (iv) less than ten hectares of agricultural land and less than ten hectares of forest land, but ten hectares or more of agricultural and forest land in total, if the legal person has been engaged, for three years immediately preceding the year of making the transaction of acquisition of the immovable, in production of agricultural products or forest management. If a legal person does not meet the requirements provided for in (ii)–(iv), the legal person may acquire an immovable which contains ten hectares or more of agricultural land, forest land or agricultural and forest land in total only with the authorisation of the council of the local government of the location of the immovable to be acquired. Restrictions on acquiring immovable property apply in certain geographical areas for non-EEA nationals. In EL: Real estate acquisition or tenancy in the border regions is prohibited to natural or legal persons whose nationality or base is outside the Member States and the European Free Trade Association. The ban may be lifted with a discretionary decision taken by a committee of the appropriate Decentralized Administration (or the Minister of National Defense in case the properties to be exploited belong to the Fund for the Exploitation of Private Public Property). In HR: Foreign companies are only allowed to acquire real estate for the supply of services if they are established and incorporated in Croatia as legal persons. Acquisition of real estate necessary for the supply of services by branches requires the approval of the Ministry of Justice. Agricultural land cannot be acquired by foreigners. In MT: Non-nationals of a Member State may not acquire immovable property for commercial purposes. Companies with 25 per cent (or more) of non-European Union shareholding must obtain an authorisation from the competent authority (Minister responsible for Finance) to buy immovable property for commercial or business purposes. The competent authority will determine whether the proposed acquisition represents a net benefit to the Maltese economy. In PL: The acquisition of real estate, direct and indirect, by foreigners requires a permit. A permit is issued through an administrative decision by a minister competent in internal affairs, with the consent of the Minister of National Defence, and in the case of agricultural real estate, also with the consent of the Minister of Agriculture and Rural Development. Measures: AT: Burgenländisches Grundverkehrsgesetz, LGBL. Nr. 25/2007; Kärntner Grundverkehrsgesetz, LGBL. Nr. 9/2004; NÖ- Grundverkehrsgesetz, LGBL. 6800; OÖ- Grundverkehrsgesetz, LGBL. Nr. 88/1994; Salzburger Grundverkehrsgesetz, LGBL. Nr. 9/2002; Steiermärkisches Grundverkehrsgesetz, LGBL. Nr. 134/1993; Tiroler Grundverkehrsgesetz, LGBL. Nr. 61/1996; Voralberger Grundverkehrsgesetz, LGBL. Nr. 42/2004; and Wiener Ausländergrundverkehrsgesetz, LGBL. Nr. 11/1998. CY: Immovable Property Acquisition (Aliens) Law (Chapter 109), as amended. CZ: Act No. 503/2012, Coll. on State Land Office as amended. DK: Danish Act on Acquisition of Real Property (Consolidation Act No. 265 of 21 March 2014 on Acquisition of Real Property); Acquisition Executive Order (Executive Order No. 764 of 18 September 1995); and The Agricultural Holdings Act (Consolidation Act No. 27 of 4 January 2017). EE: Kinnisasja omandamise kitsendamise seadus (Restrictions on Acquisition of Immovables Act) Chapter 2 § 4, Chapter 3§ 10, 2017. EL: Law 1892/1990, as it stands today, in combination, as far as the application is concerned, with the ministerial decision F.110/3/330340/S.120/7-4-14 of the Minister of National Defense and the Minister of Citizen Protection. HR: Ownership and other Proprietary Rights Act (OG 91/96, 68/98, 137/99, 22/00, 73/00, 129/00, 114/01, 79/06, 141/06, 146/08, 38/09, 143/12, 152/14), Articles 354 to 358.b; Agricultural Land Act (OG 20/18, 115/18, 98/19) Article 2; General Administrative Procedure Act. MT: Immovable Property (Acquisition by Non-Residents) Act (Cap. 246); and Protocol No 6 of the EU Accession Treaty on the acquisition of secondary residences in Malta. PL: Law of 24th March 1920 on the Acquisition of Real Estate by Foreigners (Journal of Laws of 2016, item 1061 as amended). With respect to Investment liberalisation – Market access, National treatment: In HU: The purchase of real estate by non-residents is subject to obtaining authorisation from the appropriate administrative authority responsible for the geographical location of the property. Measures: HU: Government Decree No. 251/2014 (X. 2.) on the Acquisition by Foreign Nationals of Real Estate other than Land Used for Agricultural or Forestry Purposes; and Act LXXVIII of 1993 (Paragraph 1/A). With respect to Investment liberalisation – Market access, National treatment, Most-favoured nation treatment: In LV: Acquisition of urban land by nationals of the United Kingdom is permitted through legal persons registered in Latvia or other Member States: (i) if more than 50 per cent of their equity capital is owned by nationals of Member States, the Latvian Government or a municipality, separately or in total; (ii) if more than 50 per cent of their equity capital is owned by natural persons and companies of third country with whom Latvia has concluded bilateral agreements on promotion and reciprocal protection of investments and which have been approved by the Latvian Parliament before 31 December 1996; (iii) if more than 50 per cent of their equity capital is possessed by natural persons and companies of third country with whom Latvia has concluded bilateral agreements on promotion and reciprocal protection of investments after 31 December 1996, if in those agreements the rights of Latvian natural persons and companies on acquisition of land in the respective third country have been determined; (iv) if more than 50 per cent of their equity capital is possessed jointly by persons referred to in points (i) to (iii); or (v) which are public joint stock companies, if their shares thereof are quoted in the stock exchange. Where the United Kingdom allows Latvian nationals and enterprises to purchase urban real estate in their territories, Latvia will allow nationals and enterprises of the United Kingdom to purchase urban real estate in Latvia under the same conditions as Latvian nationals. Measures: LV: Law on land reform in the cities of the Republic of Latvia, Section 20 and 21. With respect to Investment liberalisation - National treatment, Most-favoured-nation treatment: In DE: Certain conditions of reciprocity may apply for the acquisition of real estate. In ES: Foreign investment in activities directly relating to real estate investments for diplomatic missions by states that are not Member States requires an administrative authorisation from the Spanish Council of Ministers, unless there is a reciprocal liberalisation agreement in place. In RO: Foreign nationals, stateless persons and legal persons (other than nationals and legal persons of a Member State of the EEA) may acquire property rights over lands, under the conditions regulated by international treaties, based on reciprocity. Foreign nationals, stateless persons and legal persons may not acquire the property right over lands under more favourable conditions than those applicable to natural or legal persons of the European Union. Measures: DE: Einführungsgesetz zum Bürgerlichen Gesetzbuche (EGBGB; Introductory Law to the Civil Code). ES: Royal Decree 664/1999 of 23 April 1999 relating to foreign investment. RO: Law 17/2014 on some measures regulating the selling-buying agricultural land situated outside town and amending; and Law No 268/2001 on the privatization of companies that own land in public ownership and private management of the state for agricultural and establishing the State Domains Agency, with subsequent amendments. Reservation No. 2 - Professional services (except health-related professions) Sector – sub-sector: Professional services – legal services; patent agent, industrial property agent, intellectual property attorney; accounting and bookkeeping services; auditing services, taxation advisory services; architecture and urban planning services, engineering services and integrated engineering services Industry classification: CPC 861, 862, 863, 8671, 8672, 8673, 8674, part of 879 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Local presence Obligations for legal Services Chapter/Section: Investment liberalisation, Cross-border trade in services and Regulatory framework for legal services Level of government: EU/Member State (unless otherwise specified) Description: (a) Legal services (part of CPC 861) (1) With respect to Investment liberalisation – Market access – and Regulatory framework for legal services – Obligations In EU: Specific non-discriminatory legal form requirements apply in each Member State. (i) Designated legal services supplied under the home professional title (part of CPC 861 – legal advisory, arbitration, conciliation and mediation services with regard to home-jurisdiction and international law governed by Section 7 of Chapter 5 of Title II of Heading One of Part Two of this Agreement). For greater certainty, consistent with the Headnotes, in particular paragraph 9, requirements to register with a Bar may include a requirement to have completed some training under the supervision of a licensed lawyer, or to have an office or a postal address within the jurisdiction of a specific Bar in order to be eligible to apply for membership in that Bar. Some Member States may impose the requirement of having the right to practise host-jurisdiction law on those natural persons holding certain positions within a law firm/company/enterprise or for shareholders. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – National treatment, Market access and Regulatory framework for legal services – Obligations: In AT: EEA or Swiss nationality as well as residency (commercial presence) is required for the practice of legal services in respect of host jurisdiction (Union and Member State) law, including representation before courts. Only lawyers of EEA or Swiss nationality are allowed to provide legal services through commercial presence. The practice of legal services in respect of public international law and home-jurisdiction law is only allowed on a cross-border basis. Equity participation and shares in the operating result of any law firm by foreign lawyers (who must be fully qualified in their home-jurisdiction) is allowed up to 25 per cent; the rest must be held by fully qualified EEA or Swiss lawyers and only the latter may exercise decisive influence in the decision making of the law firm. In BE: (with respect also to Most-favoured-nation treatment) Foreign lawyers may practise as legal consultants. Lawyers who are members of foreign (non-EU) Bars and want to establish in Belgium but do not meet the conditions for registration on the Tableau of fully qualified lawyers, on the EU-list or on the List of Trainee Lawyers, may request registration on the so-called "B-List". Only at the Brussels Bar there exists such a "B-List". A lawyer on the B-list is allowed to supply designated legal services. In BG: (with respect also to Most-favoured-nation treatment): Permanent residency is required for legal mediation services. A mediator may be only a person who has been entered in the Uniform Register of Mediators with the Minister of Justice. In Bulgaria, full national treatment on the establishment and operation of companies, as well as on the supply of services, may be extended only to companies established in, and citizens of, countries with whom bilateral agreements on mutual legal assistance have been or will be concluded. In CY: EEA or Swiss nationality as well as residency (commercial presence) is required. Only advocates enrolled in the Bar may be partners or shareholders or members of the board of directors in a law company in Cyprus. In CZ: For foreign lawyers residence (commercial presence) is required. In DE: For foreign lawyers (with other than EEA and Swiss qualification) there may be restrictions for holding shares of a lawyers company which provides legal services in host-jurisdiction law. In DK: Without prejudice to the EU reservation above, shares of a law firm can only be owned by advocates who actively practise law in the firm, its parent company or its subsidiary company, other employees in the firm, or another law firm registered in Denmark. Other employees in the firm may collectively only own less than 10 per cent of the shares and of the voting rights, and in order to be shareholders they must pass an exam on the rules of particular importance for the practice of law. Only advocates who actively practise law in the firm, its parent company or its subsidiary company, other shareholders, and representatives of employees, may be members of the board. The majority of the members of the board must be advocates who actively practise law in the firm, its parent company or its subsidiary company. Only advocates who actively practise law in the firm, its parent company or its subsidiary company, and other shareholders having passed the exam mentioned above, may be a director of the law firm. In ES: Professional address is required in order to provide designated legal services. In FR, Residency or establishment in the EEA is required to practise on a permanent basis. Without prejudice to the EU reservation above: For all lawyers, company must take one of the following legal forms authorised under French law on a non-discriminatory basis: SCP (société civile professionnelle), SEL (société d'exercice libéral), SEP (société en participation), SARL (société à responsabilité limitée), SAS (société par actions simplifiée), SA (société anonyme), SPE (société pluriprofessionnelle d'exercice) and "association", under certain conditions. Shareholders, directors and partners may be subject to specific restrictions related to their professional activity. In HR: Only a lawyer who has the Croatian title of lawyer can establish a law firm (UK firms can establish branches, which may not employ Croatian lawyers). In HU: A cooperation contract concluded with a Hungarian attorney (ügyvéd) or law firm (ügyvédi iroda) is required. A foreign legal adviser cannot be a member of a Hungarian law firm. A foreign lawyer is not authorized for the preparation of documents to be submitted to, or act as the client's legal representative before an arbitrator, conciliator or mediator in any dispute. In PT (with respect also to Most-favoured-nation treatment): Foreigners holding a diploma awarded by any Faculty of Law in Portugal, may register with the Portuguese Bar (Ordem dos Advogados), under the same terms as Portuguese nationals, if their respective country grants Portuguese nationals reciprocal treatment. Other foreigners holding a Degree in Law which has been acknowledged by a Faculty of Law in Portugal may register as members of the Bar Association provided they undergo the required training and pass the final assessment and admission exam. Legal consultation is allowed by jurists, provided they have their professional residence ("domiciliação") in PT, pass an admission exam and are registered in the Bar. In RO: A foreign lawyer may not make oral or written conclusions before the courts and other judicial bodies, except for international arbitration. In SE: (with respect also to Most-favoured-nation treatment) Without prejudice to the EU reservation above: A member of the Swedish Bar Association may not be employed by anyone other than a Bar member or a company conducting the business of a Bar member. However, a Bar member may be employed by a foreign company conducting the business of an advocate, provided that the company in question is domiciled in a country within the Union, the EEA or the Swiss Confederation. Subject to an exemption from the Board of the Swedish Bar Association, a member of the Swedish Bar Association may also be employed by a non-European Union law firm. Bar members conducting their practice in the form of a company or a partnership may not have any other objective and may not carry out any other business than the practice of an advocate. Collaboration with other advocate businesses is permitted, however, collaboration with foreign businesses requires permission by the Board of the Swedish Bar Association. Only a Bar member may directly or indirectly, or through a company, practise as an advocate, own shares in the company or be a partner. Only a member may be a member or deputy member of the Board or deputy managing director, or an authorised signatory or secretary of the company or the partnership. In SI: (with respect also to Most-favoured-nation treatment) A foreign lawyer who has the right to practise home-jurisdiction law may supply legal services or practise law under the conditions laid down in Article 34a of the Attorneys Act, provided the condition of actual reciprocity is fulfilled. Without prejudice to the EU reservation on non-discriminatory legal form requirements, commercial presence for appointed attorneys by the Slovene Bar Association is restricted to sole proprietorship, law firm with limited liability (partnership) or to a law firm with unlimited liability (partnership) only. The activities of a law firm shall be restricted to the practice of law. Only attorneys may be partners in a law firm. In SK: For non-EU lawyers actual reciprocity is required. (ii) Other legal services (host-jurisdiction law including legal advisory, arbitration, conciliation and mediation services and legal representational services). For greater certainty, consistent with the Headnotes, in particular paragraph 9, requirements to register with a Bar may include a requirement to have obtained a law degree in the host jurisdiction or its equivalent, or to have completed some training under the supervision of a licensed lawyer, or to have an office or a postal address within the jurisdiction of a specific Bar in order to be eligible to apply for membership in that Bar. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – National treatment, Local presence: In EU: Representation of natural or legal persons before the European Union Intellectual Property Office (EUIPO) may only be undertaken by a legal practitioner qualified in one of the Member States of the EEA and having their place of business within the EEA, to the extent that they are entitled, within the said Member State, to act as a representative in trade mark matters or in industrial property matters and by professional representatives whose names appear on the list maintained for this purpose by the EUIPO. (Part of CPC 861) In AT: EEA or Swiss nationality as well as residency (commercial presence) is required for the practice of legal services in respect of host jurisdiction (Union and Member State) law, including representation before courts. Only lawyers of EEA or Swiss nationality are allowed to provide legal services through commercial presence. The practice of legal services in respect of public international law and home-jurisdiction law is only allowed on a cross-border basis. Equity participation and shares in the operating result of any law firm by foreign lawyers (who must be fully qualified in their home-jurisdiction) is allowed up to 25 per cent; the rest must be held by fully qualified EEA or Swiss lawyers and only the latter may exercise decisive influence in the decision making of the law firm. In BE: (with respect also to Most-favoured-nation treatment) Residency is required for full admission to the Bar, including for representation before courts. The residency requirement for a foreign lawyer to obtain full admission to the Bar is at least six years from the date of application for registration, three years under certain conditions. Requirement to have a certificate issued by the Belgian Minister of Foreign Affairs under which the national law or international convention allows reciprocity (reciprocity condition). Foreign lawyers may practise as legal consultants. Lawyers who are members of foreign (non-EU) Bars and want to establish in Belgium but do not meet the conditions for registration on the Tableau of fully qualified lawyers, on the EU-list or on the List of Trainee Lawyers, may request registration on the so-called "B-List". Only at the Brussels Bar there exists such a "B-List". A lawyer on the B-list is allowed to give advice. Representation before "the Cour de Cassation" is subject to nomination on a specific list. In BG: (with respect also to Most-favoured-nation treatment) Reserved to nationals of a Member State, of another State which is a party to the Agreement on the EEA, or of the Swiss Confederation who has been granted authorisation to pursue the profession of lawyer according to the legislation of any of the aforementioned countries. A foreign national (except for the above mentioned) who has been authorised to pursue the profession of lawyer in accordance with the legislation of his or her own country, may appeal before judicial bodies of the Republic of Bulgaria as defence-counsel or mandatary of a national of his or her own country, acting on a specific case, together with a Bulgarian attorney-at-law, in cases where this has been envisaged in an agreement between the Bulgarian and the respective foreign state, or on the basis of mutuality, making a preliminary request to this effect to the Chairperson of the Supreme Bar Council. Countries, in respect of which mutuality exists, shall be designated by the Minister of Justice, upon request of the Chairperson of the Supreme Bar Council. In order to provide legal mediation services, a foreign national must have a permit for long-term or permanent residence in the Republic of Bulgaria and has been entered in the Uniform Register of Mediators with the Minister of Justice. In CY: EEA or Swiss nationality as well as residency (commercial presence) is required. Only advocates enrolled in the Bar may be partners or shareholders or members of the board of directors in a law company in Cyprus. In CZ: For foreign lawyers full admission to the Czech Bar Association and residence (commercial presence) is required. In DE: Only lawyers with EEA or Swiss qualification may be admitted to the Bar and are thus entitled to provide legal services. Commercial presence is required in order to obtain full admission to the Bar. Exemptions may be granted by the competent bar association. For foreign lawyers (with other than EEA and Swiss qualification) there may be restrictions for holding shares of a lawyers company which provides legal services in domestic law. In DK: Legal services provided under the title "advokat" (advocate) or any similar title, as well as representation before the courts, is reserved for advocates with a Danish license to practise. EU, EEA and Swiss advocates may practise under the title of their country of origin. Without prejudice to the EU reservation on non-discriminatory legal form requirements, shares of a law firm can only be owned by advocates who actively practise law in the firm, its parent company or its subsidiary company, other employees in the firm, or another law firm registered in Denmark. Other employees in the firm may collectively only own less than 10 per cent of the shares and of the voting rights, and in order to be shareholders they must pass an exam on the rules of particular importance for the practice of law. Only advocates who actively practise law in the firm, its parent company or its subsidiary company, other shareholders, and representatives of employees, may be members of the board. The majority of the members of the board must be advocates who actively practise law in the firm, its parent company or its subsidiary company. Only advocates who actively practise law in the firm, its parent company or its subsidiary company, and other shareholders having passed the exam mentioned above, may be a director of the law firm. In EE: Residency (commercial presence) is required. In EL: EEA or Swiss nationality and residency (commercial presence) is required In ES: EEA or Swiss nationality is required. The competent authorities may grant nationality waivers. In FI: EEA or Swiss residency and Bar membership is required for the use of the professional title of "advocate" (in Finnish "asianajaja" or in Swedish "advokat"). Legal services may also be provided by non-Bar members. In FR: Without prejudice to the EU reservation on non-discriminatory legal form requirements, residency or establishment in the EEA is required for full admission to the Bar, necessary for the practice of legal services. In a law firm, shareholding and voting rights may be subject to quantitative restrictions related to the professional activity of the partners. Representation before "the Cour de Cassation" and "Conseil d'Etat" is subject to quotas and reserved for FR and EU nationals. For all lawyers, company must take one of the following legal forms authorised under French law on a non-discriminatory basis: SCP (société civile professionnelle), SEL (société d'exercice libéral), SEP (société en participation), SARL (société à responsabilité limitée), SAS (société par actions simplifiée), SA (société anonyme), SPE (société pluriprofessionnelle d'exercice) and "association", under certain conditions. Residency or establishment in the EEA is required to practise on a permanent basis. In HR: European Union nationality is required. In HU: EEA or Swiss nationality and residency (commercial presence) is required. In LT: (With respect also to Most-favoured-nation treatment) EEA or Swiss nationality and residency (commercial presence) is required. Attorneys from foreign countries can practise as advocates in court only in accordance with international agreements, including specific provisions regarding representation before courts. Full admission to the Bar is required. In LU (with respect also to Most-favoured-nation treatment): EEA or Swiss nationality and residency (commercial presence) is required. The Council of the Order may, on the basis of reciprocity, agree to waive the nationality requirement for a foreign national. In LV (with respect also to Most-favoured-nation treatment): EEA or Swiss nationality is required. Attorneys from foreign countries can practise as advocates in court only in accordance with bilateral agreements on mutual legal assistance. For European Union or foreign advocates, special requirements exist. For example, participation in court proceedings in criminal cases is only permitted in association with an advocate of the Latvian Collegium of Sworn Advocates. In MT: EEA or Swiss nationality as well as residency (commercial presence) is required. In NL: Only locally-licensed lawyers registered in the Dutch registry can use the title "advocate". Instead of using the full term "advocate", (non-registered) foreign lawyers are obliged to mention their home-jurisdiction professional organisation for the purposes of their activities in the Netherlands. In PT (with respect also to Most-favoured-nation treatment): residency (commercial presence) is required. For representation before courts, full admission to the Bar is required. Foreigners holding a diploma awarded by any Faculty of Law in Portugal, may register with the Portuguese Bar (Ordem dos Advogados), under the same terms as Portuguese nationals, if their respective country grants Portuguese nationals reciprocal treatment. Other foreigners holding a Degree in Law which has been acknowledged by a Faculty of Law in Portugal may register as members of the Bar Association provided they undergo the required training and pass the final assessment and admission exam. Only law firms where the shares belong exclusively to lawyers admitted to the Portuguese Bar can practise in Portugal. In RO: A foreign lawyer may not make oral or written conclusions before the courts and other judicial bodies, except for international arbitration. In SE: (with respect also to Most-favoured-nation treatment) EEA or Swiss residency is required for admission to the Bar and use of the title of "advokat". Exemptions may be granted by the board of the Swedish Bar Association. Admission to the Bar is not necessary for the practice of Swedish law. Without prejudice to the EU reservation on non-discriminatory legal form requirements, a member of the Swedish Bar Association may not be employed by anyone other than a Bar member or a company conducting the business of a Bar member. However, a Bar member may be employed by a foreign company conducting the business of an advocate, provided that the company in question is domiciled in a country within the EEA or the Swiss Confederation. Subject to an exemption from the Board of the Swedish Bar Association, a member of the Swedish Bar Association may also be employed by a non-European Union law firm. Bar members conducting their practice in the form of a company or a partnership may not have any other objective and may not carry out any other business than the practice of an advocate. Collaboration with other advocate businesses is permitted, however, collaboration with foreign businesses requires permission by the Board of the Swedish Bar Association. Only a Bar member may directly or indirectly, or through a company, practise as an advocate, own shares in the company or be a partner. Only a member may be a member or deputy member of the Board or deputy managing director, or an authorised signatory or secretary of the company or the partnership. In SI: (with respect also to Most-favoured-nation treatment) Representing clients before the court against payment is conditioned by commercial presence in Republic of Slovenia. A foreign lawyer who has the right to practise home-jurisdiction law may perform legal services or practise law under the conditions laid down in Article 34a of the Attorneys Act, provided the condition of actual reciprocity is fulfilled. Without prejudice to the EU reservation on non-discriminatory legal form requirements, commercial presence for appointed attorneys by the Slovene Bar Association is restricted to sole proprietorship, law firm with limited liability (partnership) or to a law firm with unlimited liability (partnership) only. The activities of a law firm shall be restricted to the practice of law. Only attorneys may be partners in a law firm. In SK: (with respect also to Most-favoured-nation treatment) EEA nationality as well as residency (commercial presence) is required for the practice of legal services in respect of host-jurisdiction law, including representation before courts. For non-EU lawyers actual reciprocity is required. Measures: EU: Article 120 of Regulation (EU) 2017/1001 of the European Parliament and of the Council (2); Article 78 of Council Regulation (EC) No 6/2002 of 12 December 2001 (3). AT: Rechtsanwaltsordnung (Lawyers Act) - RAO, RGBl. Nr. 96/1868, Article 1 and § 21c. BE: Belgian Judicial Code (Articles 428-508); Royal Decree of 24 August 1970. BG: Attorney Law; Law for Mediation; and Law for the Notaries and Notarial Activity. CY: Advocates Law (Chapter 2), as amended. CZ: Act No. 85/1996 Coll., the Legal Profession Act. DE: § 59e, § 59f, § 206 Bundesrechtsanwaltsordnung (BRAO; Federal Lawyers Act); Gesetz über die Tätigkeit europäischer Rechtsanwälte in Deutschland (EuRAG); and § 10 Rechtsdienstleistungsgesetz (RDG). DK: Retsplejeloven (Administration of Justice Act) chapters 12 and 13 (Consolidated Act No. 1284 of 14 November 2018). EE: Advokatuuriseadus (Bar Association Act); Tsiviilkohtumenetluse seadustik (Code of Civil Procedure); halduskohtumenetluse seadustik (Code of Administrative Court Procedure); kriminaalmenetluse seadustik (Code of Criminal Procedure); and väärteomenetluse seadustik (Code of Misdemeanour Procedure). EL: New Lawyers' Code n. 4194/2013. ES: Estatuto General de la Abogacía Española, aprobado por Real Decreto 658/2001, Article 13.1a. FI: Laki asianajajista (Advocates Act) (496/1958), ss. 1 and 3; and Oikeudenkäymiskaari (4/1734) (Code of Judicial Procedure). FR: Loi 71-1130 du 31 décembre 1971, Loi 90- 1259 du 31 décembre 1990, décret 91-1197 du 27 novembre 1991, and Ordonnance du 10 septembre 1817 modifiée. HR: Legal Profession Act (OG 9/94, 117/08, 75/09, 18/11). HU: ACT LXXVIII of 2017 on the professional activities of Attorneys at Law. LT: Law on the Bar of the Republic of Lithuania of 18 March 2004 No. IX-2066 as last amended on 12 December 2017 by law No XIII-571. LU: Loi du 16 décembre 2011 modifiant la loi du 10 août 1991 sur la profession d'avocat. LV: Criminal Procedure Law, s. 79; and Advocacy Law of the Republic of Latvia, s. 4. MT: Code of Organisation and Civil Procedure (Cap. 12). NL: Advocatenwet (Act on Advocates). PT: Law 145/2015, 9 set., alterada p/ Lei 23/2020, 6 jul. (art.o 194 substituído p/ art.o 201.o; e art.o 203.o substituído p/ art.o 213.o). Portuguese Bar Statute (Estatuto da Ordem dos Advogados) and Decree-Law 229/2004, Articles 5, 7 – 9; Decree-law 88/2003, Articles 77 and 102; Solicitadores Public Professional Association Statute (Estatuto da Câmara dos Solicitadores), as amended by Law 49/2004, mas alterada p/ Lei 154/2015, 14 set; by Law 14/2006 and by Decree-Law n.o 226/2008 alterado p/ Lei 41/2013, 26 jun; Law 78/2001, Articles 31, 4 Alterada p/ Lei 54/2013, 31 jul.; Regulation of family and labour mediation (Ordinance 282/2010), alterada p/ Portaria 283/2018, 19 out; Law 21/2007 on criminal mediation, Article 12; Law 22/2013, 26 fev., alterada p/ Lei 17/2017, 16 maio, alterada pelo Decreto-Lei 52/2019, 17 abril. RO: Attorney Law; Law for Mediation; and Law for the Notaries and the Notarial Activity. SE: Rättegångsbalken (The Swedish Code of Judicial Procedure) (1942:740); and Swedish Bar Association Code of Conduct adopted 29 August 2008. SI: Zakon o odvetništvu (Neuradno prečiščeno besedilo-ZOdv-NPB8 Državnega Zbora RS z dne 7 junij 2019 (Attorneys Act) unofficial consolidated text prepared by the Slovenian parliament from 7 June 2019). SK: Act 586/2003 on Advocacy, Articles 2 and 12. With respect to Investment liberalisation - Market access, National treatment: In PL: Foreign lawyers may establish only in the form of a registered partnership, a limited partnership or a limited joint-stock partnership. Measures: PL: Act of 5 July 2002 on the provision by foreign lawyers of legal assistance in the Republic of Poland, Article 19. With respect to Cross-Border Trade in Services – Market access In IE, IT: Residency (commercial presence) is required for the practice of legal services in respect of host-jurisdiction law, including representation before courts. Measures: IE: Solicitors Acts 1954-2011. IT: Royal Decree 1578/1933, Article 17 law on the legal profession. (b) Patent agents, industrial property agents, intellectual property attorneys (part of CPC 879, 861, 8613) With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Local presence: In AT: EEA or Swiss nationality is required for the practice of patent agency services, residency there is required. In BG, and CY: EEA or Swiss nationality is required for the practice of patent agency services. In CY, residency is required. In DE: Only patent lawyers having German qualifications may be admitted to the Bar and are thus entitled to provide patent agent services in Germany in domestic law. Foreign patent lawyers can offer legal services in foreign law when they prove expert knowledge, registration is required for legal services in Germany. Foreign (other than EEA and Swiss qualification) patent lawyers may not establish a firm together with national patent lawyers. Foreign (other than EEA and Swiss) patent lawyers may have their commercial presence only in the form of a Patentanwalts-GmbH or Patentanwalts-AG by acquiring a minority share. In EE: Estonian or EU nationality as well as permanent residency is required for the practice of patent agency services. In ES and PT: EEA nationality is required for the practice of industrial property agent services. In FR: To be registered on the industrial property agent services list, establishment or residency in the EEA is required. EEA nationality is required for natural persons. To represent a client in front of the national intellectual property office, establishment in the EEA is required. Provision only through SCP (société civile professionnelle), SEL (société d'exercice libéral) or any other legal form, under certain conditions. Irrespective of the legal form, more than half of shares and voting rights must be held by EEA professionals. Law firms may be entitled to provide industrial property agent services (see reservation for legal services). With respect to Cross-border trade in services – Local presence: In FI and HU: EEA residency is required for the practice of patent agency services. In SI: Residency in Slovenia is required for a holder/applicant of registered rights (patents, trademarks, design protection). Alternatively, a patent agent or a trademark and design agent registered in Slovenia is required for the main purpose of services of process, notification, etc. Measures: AT: Patent Attorney Act (§§ 2 and 16a). BG: Article 4 of the Ordinance for Representatives regarding Intellectual Property. CY: Advocates Law (Chapter 2), as amended. DE: Patentanwaltsordnung (PAO). EE: Patendivoliniku seadus (Patent Agents Act) § 2, § 14. ES: Ley 11/1986, de 20 de marzo, de Patentes de Invención y Modelos de utilidad, Articles 155-157. FI: Tavaramerkkilaki (Trademarks Act) (7/1964); Laki auktorisoiduista teollisoikeusasiamiehistä (Act on Authorised Industrial Property Attorneys) (22/2014); and Laki kasvinjalostajanoikeudesta (Plant Breeder's Right Act) 1279/2009; and Mallioikeuslaki (Registered Designs Act) 221/1971. FR: Code de la propriété intellectuelle. HU: Act XXXII of 1995 on Patent Attorneys. PT: Decree-Law 15/95, as modified by Law 17/2010, by Portaria 1200/2010, Article 5, and by Portaria 239/2013; and Law 9/2009. SI: Zakon o industrijski lastnini (Industrial Property Act), Uradni list RS, št. 51/06 – uradno prečiščeno besedilo in 100/13 and 23/20 (Official Gazette of the Republic of Slovenia, No. 51/06 – official consolidated text 100/13 and 23/20). With respect to Investment liberalisation – National treatment and Cross-border trade in services – National Treatment, Local presence: In IE: For establishment, at least one of the directors, partners, managers or employees of a company to be registered as a patent or intellectual property attorney in Ireland. Cross-border basis requires EEA nationality and commercial presence, principal place of business in an EEA Member State, qualification under the law of an EEA Member State. Measures: IE: Section 85 and 86 of the Trade Marks Act 1996, as amended; Rule 51, Rule 51A and Rule 51B of the Trade Marks Rules 1996, as amended; Section 106 and 107 of the Patent Act 1992, as amended; and Register of Patent Agent Rules S.I. 580 of 2015. (c) Accounting and bookkeeping services (CPC 8621 other than auditing services, 86213, 86219, 86220) With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Local presence: In AT: The capital interests and voting rights of foreign accountants, bookkeepers, qualified according to the law of their home country, in an Austrian enterprise may not exceed 25 per cent. The service supplier must have an office or professional seat in the EEA (CPC 862). In FR: Establishment or residency is required. Provision through any company form except SNC (Société en nom collectif) and SCS (Société en commandite simple). Specific conditions apply to SEL (sociétés d'exercice libéral), AGC (Association de gestion et comptabilité) and SPE (Société pluri-professionnelle d'exercice). (CPC 86213, 86219, 86220). In IT: Residence or business domicile is required for enrolment in the professional register, which is necessary for the provision of accounting and bookkeeping services (CPC 86213, 86219, 86220). In PT: (with respect also to Most-favoured-nation treatment): Residence or business domicile is required for enrolment in the professional register by the Chamber of Certified Accountants (Ordem dos Contabilistas Certificados), which is necessary for the provision of accounting services, provided that there is reciprocal treatment for Portuguese nationals. Measures: AT: Wirtschaftstreuhandberufsgesetz (Public Accountant and Auditing Profession Act, BGBl. I Nr. 58/1999), § 12, § 65, § 67, § 68 (1) 4; and Bilanzbuchhaltungsgesetz (BibuG), BGBL. I Nr. 191/2013, §§ 7, 11, 28. FR: Ordonnance 45-2138 du 19 septembre 1945. IT: Legislative Decree 139/2005; and Law 248/2006. PT: Decree-Law n.o452/99, changed by Law n.o 139/2015, september 7th. With respect to Cross-border trade in services – Local presence: In SI: Establishment in the European Union is required in order to provide accounting and bookkeeping services (CPC 86213, 86219, 86220). Measures: SI: Act on services in the internal market, Official Gazette RS No 21/10. (d) Auditing services (CPC – 86211, 86212 other than accounting and bookkeeping services) With respect to Investment liberalisation – National treatment, Most-favoured nation treatment and Cross-border trade in services – National treatment, Most-favoured nation treatment: In EU: Supply of statutory auditing services requires approval by the competent authorities of a Member State that may recognise the equivalence of the qualifications of an auditor who is a national of the United Kingdom or of any third country subject to reciprocity (CPC 8621). Measures: EU: Directive 2013/34/EU of the European Parliament and of the Council (4); and Directive 2006/43/EC of the European Parliament and of the Council (5). With respect to Investment liberalisation – Market access: In BG: Non-discriminatory legal form requirements may apply. Measures: BG: Independent Financial Audit Act. With respect to Investment liberalisation – Market access, National treatment, and Cross-border trade in services – Local presence: In AT: The capital interests and voting rights of foreign auditors, qualified according to the law of their home country, in an Austrian enterprise may not exceed 25 per cent. The service supplier must have an office or professional seat in the EEA. Measures: AT: Wirtschaftstreuhandberufsgesetz (Public Accountant and Auditing Profession Act, BGBl. I Nr. 58/1999), § 12, § 65, § 67, § 68 (1) 4. With respect to Investment liberalisation – Market access and Cross-border trade in services – Local presence: In DK: Provision of statutory auditing services requires Danish approval as an auditor. Approval requires residency in a Member State of the EEA. Voting rights in approved audit firms of auditors and audit firms not approved in accordance with regulation implementing the Directive 2006/43/EC based on Article 54(3)(g) of the Treaty on statutory audit must not exceed 10 per cent of the voting rights. In FR: (with respect also to Most-favoured-nation treatment) For statutory audits: establishment or residency is required. British nationals may provide statutory auditing services in France, subject to reciprocity. Provision through any company form except those in which partners are considered to be traders ("commerçants"), such as SNC (Société en nom collectif) and SCS (Société en commandite simple). In PL: Establishment in the European Union is required in order to provide auditing services. Legal form requirements apply. Measures: DK: Revisorloven (The Danish Act on Approved Auditors and Audit Firms), Act No. 1287 of 20/11/2018. FR: Code de commerce PL: Act of 11 May 2017 on statutory auditors, audit firms and public oversight - Journal of Laws of 2017, item 1089. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In CY: Authorisation is required, subject to an economic needs test. Main criteria: the employment situation in the sub-sector. Professional associations (partnerships) between natural persons are permitted. In SK: Only an enterprise in which at least 60 per cent of capital interests or voting rights are reserved to Slovak nationals or nationals of a Member State may be authorised to carry out audits in the Slovak Republic. Measures: CY: Auditors Law of 2017 (Law 53(I)/2017). SK: Act No. 423/2015 on Statutory audit. With respect to Investment liberalisation – Market access and Cross-border trade in services – National treatment, Local presence: In DE: Auditing companies ("Wirtschaftsprüfungsgesellschaften") may only adopt legal forms admissible within the EEA. General partnerships and limited commercial partnerships may be recognised as "Wirtschaftsprüfungsgesellschaften" if they are listed as trading partnerships in the commercial register on the basis of their fiduciary activities, Article 27 WPO. However, auditors from third countries registered in accordance with Article 134 WPO may carry out the statutory audit of annual fiscal statements or provide the consolidated financial statements of a company with its headquarters outside the Union, whose transferable securities are offered for trading in a regulated market. Measures: DE: Handelsgesetzbuch (HGB; Code of Commercial Law); Gesetz über eine Berufsordnung der Wirtschaftsprüfer (Wirtschaftsprüferordnung - WPO; Public Accountant Act). With respect to Investment liberalisation – National treatment and Cross-border trade in services – National treatment: In ES: statutory auditors must be a national of a Member State. This reservation does not apply to the auditing of non-European Union companies listed in a Spanish regulated market. Measures: ES: Ley 22/2015, de 20 de julio, de Auditoría de Cuentas (new Auditing Law: Law 22/2015 on Auditing services). With respect to Investment liberalisation – Market access, National treatment: In EE: Legal form requirements apply. The majority of the votes represented by the shares of an audit firm shall belong to sworn auditors subject to supervision of a competent authority of a EEA Member State, who have acquired their qualification in an EEA Member State, or to audit firms. At least three-fourths of the persons representing an audit firm on the basis of law shall have acquired their qualifications in an EEA Member State. Measures: EE: Auditors Activities Act (Audiitortegevuse seadus) § 76-77 With respect to Investment liberalisation – National treatment, Most-favoured nation treatment and Cross-border trade in services – Local presence: In SI Commercial presence is required. A third country audit entity may hold shares or form partnerships in Slovenian audit company provided that, under the law of the country in which the third-country audit entity is incorporated, Slovenian audit companies may hold shares or form partnership in an audit entity in that country (reciprocity requirement). Measures: SI: Auditing Act (ZRev-2), Official Gazette RS No 65/2008 (as last amended No 84/18); and Companies Act (ZGD-1), Official Gazette RS No 42/2006 (as last amended No 22/19 - ZPosS). With respect to Cross-border trade in services – Local presence: In BE: An establishment in Belgium is required where the professional activity will take place and where acts, documents and correspondence relating to it will be maintained, and to have at least one administrator or manager of the establishment approved as auditor. In FI: EEA residency required for at least one of the auditors of a Finnish Limited Liability company and of companies which are under the obligation to carry out an audit. An auditor must be a locally-licensed auditor or a locally-licensed audit firm. In HR: Auditing services may be provided only by legal persons established in Croatia or by natural persons resident in Croatia. In IT: Residency is required for the provision of auditing services by natural persons. In LT: Establishment in the EEA is required for the provision of auditing services. In SE: Only auditors approved in Sweden and auditing firms registered in Sweden may perform statutory auditing services. EEA residency is required. The titles of "approved auditor" and "authorised auditor" may only be used by auditors approved or authorised in Sweden. Auditors of co-operative economic associations and certain other enterprises who are not certified or approved accountants must be resident within the EEA, unless the Government, or a Government authority appointed by the Government, in a particular case allows otherwise. Measures: BE: Law of December 7th 2016 on the organization of the profession and the public supervision of auditors (Public Audit Act). FI: Tilintarkastuslaki (Auditing Act) (459/2007), Sectoral laws requiring the use of locally licensed auditors. HR: Audit Act (OG 146/05, 139/08, 144/12), Article 3. IT: Legislative Decree 58/1998, Articles 155, 158 and 161; Decree of the President of the Republic 99/1998; and Legislative Decree 39/2010, Article 2. LT: Law on Audit of 15 June 1999 No. VIII -1227 (a new version of 3 July 2008 No. X1676). SE: Revisorslagen (Auditors Act) (2001:883); Revisionslag (Auditing Act) (1999:1079); Aktiebolagslagen (Companies Act) (2005:551); Lag om ekonomiska föreningar (The Co-operative Economic Associations Act) (2018:672); and Others, regulating the requirements to make use of approved auditors. (e) Taxation advisory services (CPC 863, not including legal advisory and legal representational services on tax matters, which are to be found legal services) With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Local presence: In AT: The capital interests and voting rights of foreign tax advisors, qualified according to the law of their home country, in an Austrian enterprise may not exceed 25 per cent. The service supplier must have an office or professional seat in the EEA. Measures: AT: Wirtschaftstreuhandberufsgesetz (Public Accountant and Auditing Profession Act, BGBl. I Nr. 58/1999), § 12, § 65, § 67, § 68 (1) 4. With respect to Investment liberalisation – Market access and Cross-border trade in services – Local presence: In FR: Establishment or residency is required. Provision through any company form except SNC (Société en nom collectif) and SCS (Société en commandite simple). Specific conditions apply to SEL (sociétés d'exercice libéral), AGC (Association de gestion et comptabilité) and SPE (Société pluri-professionnelle d'exercice). Measures: FR: Ordonnance 45-2138 du 19 septembre 1945. With respect to Investment liberalisation – National treatment and Cross-border trade in services – National treatment: In BG: Nationality of a Member State is required for tax advisors. Measures: BG: Accountancy Act; Independent Financial Audit Act; Income Taxes on Natural Persons Act; and Corporate Income Tax Act. With respect to Cross-border trade in services – Local presence: In HU: EEA residency is required for the supply of taxation advisory services. In IT: Residency is required. Measures: HU: Act 150 of 2017 on taxing; Government Decree 2018/263 on the registration and training of taxation advisory activities. IT: Legislative Decree 139/2005; and Law 248/2006. (f) Architecture and urban planning services, engineering and integrated engineering services (CPC 8671, 8672, 8673, 8674) With respect to Investment liberalisation – Market access: In FR: An architect may only establish in France in order to provide architectural services using one of the following legal forms (on a non-discriminatory basis): SA et SARL (sociétés anonymes, à responsabilité limitée), EURL (Entreprise unipersonnelle à responsabilité limitée), SCP (en commandite par actions), SCOP (Société coopérative et participative), SELARL (société d'exercice libéral à responsabilité limitée), SELAFA (société d'exercice libéral à forme anonyme), SELAS (société d'exercice libéral) or SAS (Société par actions simplifiée), or as individual or as a partner in an architectural firm (CPC 8671). Measures: FR: Loi 90-1258 relative à l'exercice sous forme de société des professions libérales; Décret 95-129 du 2 février 1995 relatif à l'exercice en commun de la profession d'architecte sous forme de société en participation; Décret 92-619 du 6 juillet 1992 relatif à l'exercice en commun de la profession d'architecte sous forme de société d'exercice libéral à responsabilité limitée SELARL, société d'exercice libéral à forme anonyme SELAFA, société d'exercice libéral en commandite par actions SELCA; and Loi 77-2 du 3 janvier 1977. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In BG: Residency in the EEA or the Swiss Confederation is required for architecture, urban planning and engineering services provided by natural persons. Measures: BG: Spatial Development Act; Chamber of Builders Act; and Chambers of Architects and Engineers in Project Development Design Act. With respect to Investment liberalisation – National treatment and Cross-border trade in services – National treatment: In HR: A design or project created by a foreign architect, engineer or urban planner must be validated by an authorised natural or legal person in Croatia with regard to its compliance with Croatian Law (CPC 8671, 8672, 8673, 8674). Measures: HR: Act on Physical Planning and Building Activities (OG 118/18, 110/19) Physical Planning Act (OG 153/13, 39/19). With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – National treatment, Local presence: In CY: Nationality and residency condition applies for the provision of architecture and urban planning services, engineering and integrated engineering services (CPC 8671, 8672, 8673, 8674). Measures: CY: Law 41/1962 as amended; Law 224/1990 as amended; and Law 29(I)2001 as amended. With respect to Cross-border trade in services – Local presence: In CZ: Residency in the EEA is required. In HU: EEA residency is required for the supply of the following services, insofar as they are being supplied by a natural person present in the territory of Hungary: architectural services, engineering services (only applicable to graduate trainees), integrated Engineering services and landscape architectural services (CPC 8671, 8672, 8673, 8674). In IT: residency or professional domicile/business address in Italy is required for enrolment in the professional register, which is necessary for the exercise of architectural and engineering services (CPC 8671, 8672, 8673, 8674). In SK: Residency in the EEA is required for registration in the professional chamber, which is necessary for the exercise of architectural and engineering services (CPC 8671, 8672, 8673, 8674). Measures: CZ: Act no. 360/1992 Coll. on practice of profession of authorised architects and authorised engineers and technicians working in the field of building constructions. HU: Act LVIII of 1996 on the Professional Chambers of Architects and Engineers. IT: Royal Decree 2537/1925 regulation on the profession of architect and engineer; Law 1395/1923; and Decree of the President of the Republic (D.P.R.) 328/2001. SK: Act 138/1992 on Architects and Engineers, Articles 3, 15, 15a, 17a and 18a. With respect to Cross-border trade in services – Market access, National treatment: In BE: the provision of architectural services includes control over the execution of the works (CPC 8671, 8674). Foreign architects authorised in their host countries and wishing to practice their profession on an occasional basis in Belgium are required to obtain prior authorisation from the Council of Order in the geographical area where they intend to practice their activity. Measures: BE: Law of February 20, 1939 on the protection of the title of the architect's profession; and Law of 26th June 1963, which creates the Order of Architects Regulations of December 16th, 1983 of ethics established by national Council in the Order of Architects (Approved by Article 1st of A.R. of April 18th, 1985, M.B., May 8th, 1985). Reservation No. 3 - Professional services (health related and retail of pharmaceuticals) Sector – sub-sector: Professional services – medical (including psychologists) and dental services; midwives, nurses, physiotherapists and paramedical personnel; veterinary services; retail sales of pharmaceutical, medical and orthopaedic goods and other services provided by pharmacists Industry classification: CPC 9312, 93191, 932, 63211 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Local presence Chapter/Section: Investment Liberalisation and Cross-Border Trade in Services Description: (a) Medical, dental, midwives, nurses, physiotherapists and para-medical services (CPC 852, 9312, 93191) With respect to Investment liberalisation – National treatment, Most favoured nation treatment and Cross-border trade in services – National treatment, Most favoured nation treatment: In IT: European Union nationality is required for the services provided by psychologists, foreign professionals may be allowed to practice based on reciprocity (part of CPC 9312). Measures: IT: Law 56/1989 on the psychologist profession. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market Access, National treatment, Local presence: In CY: Cypriot nationality and residency condition applies for the provision of medical (including psychologists), dental, midwives, nurses, physiotherapists and para-medical services. Measures: CY: Registration of Doctors Law (Chapter 250) as amended; Registration of Dentists Law (Chapter 249) as amended; Law 75(I)/2013 - Podologists; Law 33(I)/2008 as amended- Medical Physics; Law 34(I)/2006 as amended - Occupational Therapists; Law 9(I)/1996 as amended - Dental Technicians; Law 68(I)/1995 as amended - Psychologists; Law 16(I)/1992 as amended - Opticians; Law 23(I)/2011 as amended - Radiologists/Radiotherapists; Law 31(I)/1996 as amended - Dieticians/Nutritionists; Law 140/1989 as amended - Physiotherapists; and Law 214/1988 as amended - Nurses. With respect to Investment liberalisation – Market Access and Cross-border trade in services – Market access, Local presence: In DE (applies also to the regional level of government): Geographical restrictions may be imposed on professional registration, which apply to nationals and non-nationals alike. Doctors (including psychologists, psychotherapists, and dentists) need to register with the regional associations of statutory health insurance physicians or dentists (kassenärztliche or kassenzahnärztliche Vereinigungen), if they wish to treat patients insured by the statutory sickness funds. This registration can be subject to quantitative restrictions based on the regional distribution of doctors. For dentists this restriction does not apply. Registration is necessary only for doctors participating in the public health scheme. Non-discriminatory restrictions on the legal form of establishment required to provide these services may exist (§ 95 SGB V). For midwives services, access is restricted to natural persons only. For medical and dental services, access is possible for natural persons, licensed medical care centres and mandated bodies. Establishment requirements may apply. Regarding telemedicine, the number of ICT (information and communications technology) - service suppliers may be limited to guarantee interoperability, compatibility and necessary safety standards. This is applied in a non-discriminatory way (CPC 9312, 93191). Measures: Bundesärzteordnung (BÄO; Federal Medical Regulation); Gesetz über die Ausübung der Zahnheilkunde (ZHG); Gesetz über den Beruf der Psychotherapeutin und des Psychotherapeuten (PsychThG; Act on the Provision of Psychotherapy Services); Gesetz über die berufsmäßige Ausübung der Heilkunde ohne Bestallung (Heilpraktikergesetz); Gesetz über das Studium und den Beruf von Hebammen(HebG); Gesetz über die Pflegeberufe (PflBG); Sozialgesetzbuch Fünftes Buch (SGB V; Social Code, Book Five) - Statutory Health Insurance. Regional level: Heilberufekammergesetz des Landes Baden-Württemberg; Gesetz über die Berufsausübung, die Berufsvertretungen und die Berufsgerichtsbarkeit der Ärzte, Zahnärzte, Tierärzte, Apotheker sowie der Psychologischen Psychotherapeuten und der Kinder- und Jugendlichenpsychotherapeuten (Heilberufe-Kammergesetz - HKaG) in Bayern; Berliner Heilberufekammergesetz (BlnHKG); Heilberufsgesetz Brandenburg (HeilBerG); Bremisches Gesetz über die Berufsvertretung, die Berufsausübung, die Weiterbildung und die Berufsgerichtsbarkeit der Ärzte, Zahnärzte, Psychotherapeuten, Tierärzte und Apotheker (Heilberufsgesetz - HeilBerG); Heilberufsgesetz Mecklenburg-Vorpommern (Heilberufsgesetz M-V – HeilBerG); Heilberufsgesetz (HeilBG NRW); Heilberufsgesetz (HeilBG Rheinland-Pfalz); Gesetz über die öffentliche Berufsvertretung, die Berufspflichten, die Weiterbildung und die Berufsgerichtsbarkeit der Ärzte/ Ärztinnen, Zahnärzte/ Zahnärztinnen, psychologischen Psychotherapeuten/ Psychotherapeutinnen und Kinder- und Jugendlichenpsychotherapeuten/psychotherapeutinnen, Tierärzte/Tierärztinnen und Apotheker/Apothekerinnen im Saarland (Saarländisches Heilberufekammergesetz - SHKG); Gesetz über Berufsausübung, Berufsvertretungen und Berufsgerichtsbarkeit der Ärzte, Zahnärzte, Tierärzte, Apotheker sowie der Psychologischen Psychotherapeuten und der Kinder und Jugendlichenpsychotherapeuten im Freistaat (Sächsisches Heilberufekammergesetz – SächsHKaG)and Thüringer Heilberufegesetz. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, Local presence: In FR: While other types of legal form are also available for Union investors, foreign investors only have access to the legal forms of "société d'exercice liberal"(SEL) and "société civile professionnelle" (SCP). For medical, dental and midwives services, French nationality is required. However, access by foreigners is possible within annually established quotas. For medical, dental and midwives services and services by nurses, provision through SEL à forme anonyme, à responsabilité limitée par actions simplifiée ou en commandite par actions SCP, société coopérative (for independent general and specialised practitioners only) or société interprofessionnelle de soins ambulatoires (SISA) for multidisciplinary health home (MSP) only. Measures: FR: Loi 90-1258 relative à l'exercice sous forme de société des professions libérales, Loi n°2011-940 du 10 août 2011 modifiant certaines dipositions de la loi n°2009-879 dite HPST, Loi n°47-1775 portant statut de la coopération; and Code de la santé publique. With respect to Investment liberalisation – Market access: In AT: Cooperation of physicians for the purpose of ambulatory public healthcare, so-called group practices, can take place only under the legal form of Offene Gesellschaft/OG or Gesellschaft mit beschränkter Haftung/GmbH. Only physicians may act as associates of such a group practice. They must be entitled to independent medical practice, registered with the Austrian Medical Chamber and actively pursue the medical profession in the practice. Other natural or legal persons may not act as associates of the group practice and may not take share in its revenues or profits (part of CPC 9312). Measures: AT: Medical Act, BGBl. I Nr. 169/1998, §§ 52a - 52c; Federal Act Regulating High Level Allied Health Professions, BGBl. Nr. 460/1992; and Federal Act regulating Medical Masseurs lower and upper level, BGBl. Nr. 169/2002. (b) Veterinary services (CPC 932) With respect to Investment liberalisation – Market access, National treatment, Most-favoured nation treatment and Cross-border trade in services – Market access, National treatment, Most-favoured nation treatment: In AT: Only nationals of a Member State of the EEA may provide veterinary services. The nationality requirement is waived for nationals of a non-Member State of the EEA where there is a Union agreement with that non-Member State of the EEA providing for national treatment with respect to investment and cross-border trade of veterinary services. In ES: Membership in the professional association is required for the practice of the profession and requires Union nationality, which may be waived through a bilateral professional agreement. The provision of veterinary services is restricted to natural persons. In FR: EEA nationality is required for the supply of veterinary services, but the nationality requirement may be waived subject to reciprocity. The legal forms available to a company providing veterinary services are limited to SCP (Société civile professionnelle) and SEL (Société d'exercice liberal). Other legal forms of company provided for by French domestic law or the law of another Member State of the EEA and having their registered office, central administration or principal place of business therein may be authorised, under certain conditions. Measures: AT: Tierärztegesetz (Veterinary Act), BGBl. Nr. 16/1975, §3 (2) (3). ES: Real Decreto 126/2013, de 22 de febrero, por el que se aprueban los Estatutos Generales de la Organización Colegial Veterinaria Española; Articles 62 and 64. FR: Code rural et de la pêche maritime. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – National treatment, Local presence: In CY: Nationality and residency condition applies for the provision of veterinary services. In EL: EEA or Swiss nationality is required for the supply of veterinary services. In HR: Only legal and natural persons established in a Member State for the purpose of conducting veterinary activities can supply cross border veterinary services in the Republic of Croatia. Only Union nationals can establish a veterinary practice in the Republic of Croatia. In HU: EEA nationality is required for membership of the Hungarian Veterinary Chamber, necessary for supplying veterinary services. Authorisation for establishment is subject to an economic needs test. Main criteria: labour market conditions in the sector. Measures: CY: Law 169/1990 as amended. EL: Presidential Degree 38/2010, Ministerial Decision 165261/IA/2010 (Gov. Gazette 2157/B). HR: Veterinary Act (OG 83/13, 148/13, 115/18), Articles 3 (67), Articles 105 and 121. HU: Act CXXVII of 2012 on the Hungarian Veterinary Chamber and on the conditions how to supply Veterinary services. With respect to Cross-border trade in services – Local presence: In CZ: Physical presence in the territory is required for the supply of veterinary services. In IT and PT: Residency is required for the supply of veterinary services. In PL: Physical presence in the territory is required for the supply of veterinary services to pursue the profession of veterinary surgeon present in the territory of Poland, non- European Union nationals have to pass an exam in Polish language organized by the Polish Chambers of Veterinary Surgeons. In SI: Only legal and natural persons established in a Member State for the purpose of conducting veterinary activities can supply cross border veterinary services in to the Republic of Slovenia. With respect to Investment liberalisation – Market acces, and Cross-border trade in services –Market access: In SK: Residency in the EEA is required for registration in the professional chamber, which is necessary for the exercise of the profession. The provision of veterinary services is restricted to natural persons. Measures: CZ: Act No. 166/1999 Coll. (Veterinary Act), §58-63, 39; and Act No. 381/1991 Coll. (on the Chamber of Veterinary Surgeons of the Czech Republic), paragraph 4. IT: Legislative Decree C.P.S. 233/1946, Articles 7-9; and Decree of the President of the Republic (DPR) 221/1950, paragraph 7. PL: Law of 21st December 1990 on the Profession of Veterinary Surgeon and Chambers of Veterinary Surgeons. PT: Decree-Law 368/91 (Statute of the Veterinary Professional Association) alterado p/ Lei 125/2015, 3 set. SI Pravilnik o priznavanju poklicnih kvalifikacij veterinarjev (Rules on recognition of professional qualifications for veterinarians), Uradni list RS, št. (Official Gazette No) 71/2008, 7/2011, 59/2014 in 21/2016, Act on services in the internal market, Official Gazette RS No 21/2010. SK: Act 442/2004 on Private Veterinary Doctors and the Chamber of Veterinary Doctors, Article 2. With respect to Investment liberalisation – Market access and Cross-border trade in services – Market access: In DE (applies also to the regional level of government): The supply of veterinary services is restricted to natural persons. Telemedicine may only be provided in the context of a primary treatment involving the prior physical presence of a veterinary. In DK and NL: The supply of veterinary services is restricted to natural persons. In IE: The supply of veterinary services is restricted to natural persons or partnerships. In LV: The supply of veterinary services is restricted to natural persons. Measures: DE: Bundes-Tierärzteordnung (BTÄO; Federal Code for the Veterinary Profession). Regional level: Acts on the Councils for the Medical Profession of the Länder (Heilberufs- und Kammergesetze der Länder) and (based on these) Baden-Württemberg, Gesetz über das Berufsrecht und die Kammern der Ärzte, Zahnärzte, Tierärzte Apotheker, Psychologischen Psychotherapeuten sowie der Kinder- und Jugendlichenpsychotherapeuten (Heilberufe-Kammergesetz - HBKG); Bayern, Gesetz über die Berufsausübung, die Berufsvertretungen und die Berufsgerichtsbarkeit der Ärzte, Zahnärzte, Tierärzte, Apotheker sowie der Psychologischen Psychotherapeuten und der Kinder- und Jugendlichenpsychotherapeuten (Heilberufe-Kammergesetz - HKaG); Berliner Heilberufekammergesetz (BlnHKG); Brandenburg, Heilberufsgesetz (HeilBerG); Bremen, Gesetz über die Berufsvertretung, die Berufsausübung, die Weiterbildung und die Berufsgerichtsbarkeit der Ärzte, Zahnärzte, Psychotherapeuten, Tierärzte und Apotheker (Heilberufsgesetz - HeilBerG); Hamburg, Hamburgisches Kammergesetz für die Heilberufe (HmbKGH); Hessen, Gesetz über die Berufsvertretungen, die Berufsausübung, die Weiterbildung und die Berufsgerichtsbarkeit der Ärzte, Zahnärzte, Tierärzte, Apotheker, Psychologischen Psychotherapeuten und Kinder- und Jugendlichenpsychotherapeuten (Heilberufsgesetz); Mecklenburg-Vorpommern, Heilberufsgesetz (HeilBerG); Niedersachsen, Kammergesetz für die Heilberufe (HKG); Nordrhein-Westfalen, Heilberufsgesetz NRW (HeilBerg); Rheinland-Pfalz, Heilberufsgesetz (HeilBG); Saarland, Gesetz Nr. 1405 über die öffentliche Berufsvertretung, die Berufspflichten, die Weiterbildung und die Berufsgerichtsbarkeit der Ärzte/Ärztinnen, Zahnärzte/Zahnärztinnen, Tierärzte/Tierärztinnen und Apotheker/Apothekerinnen im Saarland (Saarländisches Heilberufekammergesetz - SHKG); Sachsen, Gesetz über Berufsausübung, Berufsvertretungen und Berufsgerichtsbarkeit der Ärzte, Zahnärzte, Tierärzte, Apotheker sowie der Psychologischen Psychotherapeuten und der Kinder- und Jugendlichenpsychotherapeuten im Freistaat Sachsen (Sächsisches Heilberufekammergesetz – SächsHKaG); Sachsen-Anhalt, Gesetz über die Kammern für Heilberufe Sachsen-Anhalt (KGHB-LSA); Schleswig-Holstein, Gesetz über die Kammern und die Berufsgerichtsbarkeit für die Heilberufe (Heilberufekammergesetz - HBKG); Thüringen, Thüringer Heilberufegesetz (ThürHeilBG); and Berufsordnungen der Kammern (Codes of Professional Conduct of the Veterinary Practitioners' Councils). DK: Lovbekendtgørelse nr. 40 af lov om dyrlæger af 15. januar 2020 (Consolidated act no. 40 of January 15th, 2020, on veterinary surgeons). IE: Veterinary Practice Act 2005. LV: Veterinary Medicine Law. NL: Wet op de uitoefening van de diergeneeskunde 1990 (WUD). (c) Retail sales of pharmaceuticals, medical and orthopaedic goods and other services provided by pharmacists (CPC 63211) With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors: In AT: The retail of pharmaceuticals and specific medical goods to the public may only be carried out through a pharmacy. Nationality of a Member State of the EEA or the Swiss Confederation is required in order to operate a pharmacy. Nationality of a Member State of the EEA or the Swiss Confederation is required for leaseholders and persons in charge of managing a pharmacy. Measures: AT: Apothekengesetz (Pharmacy Law), RGBl. Nr. 5/1907 as amended, §§ 3, 4, 12; Arzneimittelgesetz (Medication Act), BGBl. Nr. 185/1983 as amended, §§ 57, 59, 59a; and Medizinproduktegesetz (Medical Products Law), BGBl. Nr. 657/1996 as amended, § 99. With respect to Investment liberalisation – Market Access, National Treatment: In DE: Only natural persons (pharmacists) are permitted to operate a pharmacy. Nationals of other countries or persons who have not passed the German pharmacy exam may only obtain a licence to take over a pharmacy which has already existed during the preceding three years. The total number of pharmacies per person is restricted to one pharmacy and up to three branch pharmacies. In FR: EEA or Swiss nationality is required in order to operate a pharmacy. Foreign pharmacists may be permitted to establish within annually established quotas. Pharmacy opening must be authorised and commercial presence including sale at a distance of medicinal products to the public by means of information society services, must take one of the legal forms which are allowed under national law on a non-discriminatory basis: société d'exercice libéral (SEL) anonyme, par actions simplifiée, à responsabilité limitée unipersonnelle or pluripersonnelle, en commandite par actions, société en noms collectifs (SNC) or société à responsabilité limitée (SARL) unipersonnelle or pluripersonnelle only. Measures: DE: Gesetz über das Apothekenwesen (ApoG; German Pharmacy Act); Gesetz über den Verkehr mit Arzneimitteln (AMG); Gesetz über Medizinprodukte (MPG); Verordnung zur Regelung der Abgabe von Medizinprodukten (MPAV) FR: Code de la santé publique; and Loi 90-1258 du 31 décembre 1990 relative à l'exercice sous forme de société des professions libérales and Loi 2015-990 du 6 août 2015. With respect to Investment liberalisation – National Treatment: In EL: European Union nationality is required in order to operate a pharmacy. In HU: EEA nationality is required in order to operate a pharmacy. In LV: In order to commence independent practice in a pharmacy, a foreign pharmacist or pharmacist's assistant, educated in a state which is not a Member State or a Member State of the EEA, must work for at least one year in a pharmacy in a Member State of the EEA under the supervision of a pharmacist. Measures: EL: Law 5607/1932 as amended by Laws 1963/1991 and 3918/2011. HU: Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products. LV: Pharmaceutical Law, s. 38. With respect to Investment liberalisation – Market access: In BG: Managers of pharmacies must be qualified pharmacists and may only manage one pharmacy in which they themselves work. A quota (not more than 4) exists for the number of pharmacies which may be owned per person in the Republic of Bulgaria. In DK: Only natural persons, who have been granted a pharmacist licence from the Danish Health and Medicines Authority, are permitted to provide retail services of pharmaceuticals and specific medical goods to the public. In ES, HR, HU, and PT: Establishment authorisation is subject to an economic needs test. Main criteria: population and density conditions in the area. In IE: The mail order of pharmaceuticals is prohibited, with the exception of non-prescription medicines. In MT: Issuance of Pharmacy licences under specific restrictions. No person shall have more than one licence in his name in any town or village (Regulation 5(1) of the Pharmacy Licence Regulations (LN279/07)), except in the case where there are no further applications for that town or village (Regulation 5(2) of the Pharmacy Licence Regulations (LN279/07)). In PT: In commercial companies where the capital is represented by shares, these shall be nominative. A person shall not hold or exercise, at the same time, directly or indirectly, ownership, operation or management of more than four pharmacies. In SI The network of pharmacies in Slovenia consists of public pharmacy institutions, owned by municipalities, and of private pharmacists with concession where the majority owner must be a pharmacist by profession. Mail order of pharmaceuticals requiring a prescription is prohibited. Mail order of non-prescription medicines requires special state permission. Measures: BG: Law on Medicinal Products in Human Medicine, arts. 222, 224, 228. DK: Apotekerloven (Danish Pharmacy Act) LBK nr. 801 12/06/2018. ES: Ley 16/1997, de 25 de abril, de regulación de servicios de las oficinas de farmacia (Law 16/1997, of 25 April, regulating services in pharmacies), Articles 2, 3.1; and Real Decreto Legislativo 1/2015, de 24 de julio por el que se aprueba el Texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios (Ley 29/2006). HR: Health Care Act (OG 100/18, 125/19). HU: Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products. IE: Irish Medicines Boards Acts 1995 and 2006 (No. 29 of 1995 and No. 3 of 2006); Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended (S.I. 540 of 2003); Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended (S.I. 540 of 2007); Pharmacy Act 2007 (No. 20 of 2007); Regulation of Retail Pharmacy Businesses Regulations 2008, as amended, (S.I. No 488 of 2008). MT: Pharmacy Licence Regulations (LN279/07) issued under the Medicines Act (Cap. 458). PT: Decree-Law 307/2007, Articles 9, 14 and 15 Alterado p/ Lei 26/2011, 16 jun., alterada: — p/ Acórdão TC 612/2011, 24/01/2012, — p/ Decreto-Lei 171/2012, 1 ago., — p/ Lei 16/2013, 8 fev., — p/ Decreto-Lei 128/2013, 5 set., — p/ Decreto-Lei 109/2014, 10 jul., — p/ Lei 51/2014, 25 ago., — p/ Decreto-Lei 75/2016, 8 nov.; and Ordinance 1430/2007revogada p/ Portaria 352/2012, 30 out. SI Pharmacy Services Act (Official Gazette of the RS No. 85/2016, 77/2017, 73/2019); and Medicinal Products Act (Official Gazette of the RS, No. 17/2014, 66/2019). With respect to Investment liberalisation – Market Access, National treatment, Most-Favoured Nation treatment and Cross-border trade in services – Market access, National treatment: In IT: The practice of the profession is possible only for natural persons enrolled in the register, as well as for legal persons in the form of partnerships, where every partner of the company must be an enrolled pharmacist. Enrolment in the pharmacist professional register requires nationality of a Member State of the European Union or residency and the practice of the profession in Italy. Foreign nationals having the necessary qualifications may enrol if they are citizens of a country with whom Italy has a special agreement, authorising the exercise of the profession, under condition of reciprocity (D. Lgsl. CPS 233/1946 Articles 7-9 and D.P.R. 221/1950 paragraphs 3 and 7). New or vacant pharmacies are authorised following a public competition. Only nationals of a Member State of the European Union enrolled in the Register of pharmacists ("albo") are able to participate in a public competition. Establishment authorisation is subject to an economic needs test. Main criteria: population and density conditions in the area. Measures: IT: Law 362/1991, Articles 1, 4, 7 and 9; Legislative Decree CPS 233/1946, Articles 7-9; and Decree of the President of the Republic (D.P.R. 221/1950, paragraphs 3 and 7). With respect to Investment liberalisation – Market Access, National treatment and Cross-border trade in services – Market access, National treatment: In CY: Nationality requirement applies for the provision of retail sales of pharmaceuticals, medical and orthopaedic goods and other services provided by pharmacists (CPC 63211). Measures: CY: Pharmacy and Poisons Law (Chapter 254) as amended. With respect to Investment liberalisation – Market access and Cross-border services – Market access: In BG The retail of pharmaceuticals and specific medical goods to the public may only be carried out through a pharmacy. The mail order of pharmaceuticals is prohibited, with the exception of non-prescription medicines. In EE: The retail of pharmaceuticals and specific medical goods to the public may only be carried out through a pharmacy. Mail order sale of medicinal products as well as delivery by post or express service of medicinal products ordered through the Internet is prohibited. Establishment authorisation is subject to an economic needs test. Main criteria: density conditions in the area. In EL: Only natural persons, who are licenced pharmacists, and companies founded by licenced pharmacists, are permitted to provide retail services of pharmaceuticals and specific medical goods to the public. In ES: Only natural persons, who are licenced pharmacists, are permitted to provide retail services of pharmaceuticals and specific medical goods to the public. Each pharmacist cannot obtain more than one licence. In LU: Only natural persons are permitted to provide retail services of pharmaceuticals and specific medical goods to the public. In NL: Mail order of medicine is subject to requirements. Measures: BG: Law on Medicinal Products in Human Medicine, arts.219, 222, 228, 234(5). EE: Ravimiseadus (Medicinal Products Act), RT I 2005, 2, 4; § 29 (2) and § 41 (3); and Tervishoiuteenuse korraldamise seadus (Health Services Organisation Act, RT I 2001, 50, 284). EL: Law 5607/1932 as amended by Laws 1963/1991 and 3918/2011. ES: Ley 16/1997, de 25 de abril, de regulación de servicios de las oficinas de farmacia (Law 16/1997, of 25 April, regulating services in pharmacies), Articles 2, 3.1; and Real Decreto Legislativo 1/2015, de 24 de julio por el que se aprueba el Texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios (Ley 29/2006). LU: Loi du 4 juillet 1973 concernant le régime de la pharmacie (annex a043); Règlement grand-ducal du 27 mai 1997 relatif à l'octroi des concessions de pharmacie (annex a041); and Règlement grand-ducal du 11 février 2002 modifiant le règlement grand-ducal du 27 mai 1997 relatif à l'octroi des concessions de pharmacie (annex a017). NL: Geneesmiddelenwet, article 67. With respect to Investment liberalisation – National treatment and Cross-border services – Local presence: In BG: Permanent residency is required for pharmacists. Measures: BG: Law on Medicinal Products in Human Medicine, arts. 146, 161, 195, 222, 228. With respect to Cross-border trade in services – Local presence: In DE, SK: Residency is required in order to obtain a licence as a pharmacist or to open a pharmacy for the retail of pharmaceuticals and certain medical goods to the public. Measures: DE: Gesetz über das Apothekenwesen (ApoG; German Pharmacy Act); Gesetz über den Verkehr mit Arzneimitteln (AMG); Gesetz über Medizinprodukte (MPG); Verordnung zur Regelung der Abgabe von Medizinprodukten (MPAV). SK: Act 362/2011 on pharmaceuticals and medical devices, Article 6; and Act 578/2004 on healthcare providers, medical employees, professional organisation in healthcare. Reservation No. 4 - Research and development services Sector – sub-sector: Research and development (R&D) services Industry classification: CPC 851, 853 Type of reservation: Market access National treatment Chapter: Investment liberalisation and Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: The EU: For publicly funded research and development (R&D) services benefitting from funding provided by the Union at the Union level, exclusive rights or authorisations may only be granted to nationals of the Member States and to legal persons of the Union having their registered office, central administration or principal place of business in the Union (CPC 851, 853). For publicly funded R&D services benefitting from funding provided by a Member State exclusive rights or authorisations may only be granted to nationals of the Member State concerned and to legal persons of the Member State concerned having their headquarters in that Member State (CPC 851, 853). This reservation is without prejudice to Part Five of this Agreement and to the exclusion of procurement by a Party or subsidies, in Article 123(6) and (7) of this Agreement. Measures: EU: All currently existing and all future Union research or innovation framework programmes, including the Horizon 2020 Rules for Participation and regulations pertaining to Joint Technology Initiatives (JTIs), Article 185 Decisions, and the European Institute for Innovation and Technology (EIT), as well as existing and future national, regional or local research programmes. Reservation No. 5 - Real estate services Sector – sub-sector: Real estate services Industry classification: CPC 821, 822 Type of reservation: Market access National treatment Most-favoured nation treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – National treatment, Local presence: In CY: For the supply of real estate services, nationality and residency condition applies. Measures: CY: The Real Estate Agents Law 71(1)/2010 as amended. With respect to Cross-border trade in services – Local presence: In CZ: Residency for natural persons and establishment for legal persons in the Czech Republic are required to obtain the licence necessary for the provision of real estate services. In HR: Commercial presence in EEA is required to supply real estate services. In PT: EEA residency is required for natural persons. EEA incorporation is required for legal persons. Measures: CZ: Trade Licensing Act. HR: Real Estate Brokerage Act (OG 107/07 and 144/12), Article 2. PT: Decree-Law 211/2004 (Articles 3 and 25), as amended and republished by Decree-Law 69/2011. With respect to Investment liberalisation – National treatment and Cross-border trade in services – Local presence: In DK: For the supply of real estate services by a natural person present in the territory of Denmark, only authorised real estate agent who are natural persons that have been admitted to the Danish Business Authority's real estate agent register may use the title of "real estate agent". The act requires that the applicant be a Danish resident or a resident of the Union, EEA or the Swiss Confederation. The Act on the sale of real estate is only applicable when providing real estate services to consumers. The Act on the sale of real estate does not apply to the leasing of real estate (CPC 822). Measures: DK: Lov om formidling af fast ejendom m.v. lov. nr. 526 af 28.05.2014 (The Act on the sale of real estate). With respect to Cross-border trade in services – Market access, National treatment, Most-favoured-nation treatment: In SI: In so far as the United Kingdom allows Slovenian nationals and enterprises to supply real estate agent services, Slovenia will allow nationals of the United Kingdom and enterprises to supply real estate agent services under the same conditions, in addition to the fulfilment of the following requirements: entitlement to act as a real estate agent in the country of origin, submission of the relevant document on impunity in criminal procedures, and inscription into the registry of real estate agents at the competent (Slovenian) ministry. Measures: SI: Real Estate Agencies Act. Reservation No. 6 - Business services Sector – sub-sector: Business services - rental or leasing services without operators; services related to management consulting; technical testing and analyses; related scientific and technical consulting services; services incidental to agriculture; security services; placement services; translation and interpretation services and other business services Industry classification: ISIC Rev. 37, part of CPC 612, part of 621, part of 625, 831, part of 85990, 86602, 8675, 8676, 87201, 87202, 87203, 87204, 87205, 87206, 87209, 87901, 87902, 87909, 88, part of 893 Type of reservation: Market access National treatment Most-favoured nation treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation and Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: (a) Rental or leasing services without operators (CPC 83103, CPC 831) With respect to Investment liberalisation – Market access, National treatment: In SE: To fly the Swedish flag, proof of dominating Swedish operating influence must be shown in case of foreign ownership interests in ships. Dominating Swedish operating influence means that the operation of the ship is located in Sweden and that the ship also has a more than half of the shares of either Swedish ownership or ownership of persons in another EEA country. Other foreign ships may under certain conditions be granted an exemption from this rule where they are rented or leased by Swedish legal persons through bareboat charter contracts (CPC 83103). Measures: SE: Sjölagen (Maritime Law) (1994:1009), Chapter 1, § 1. With respect to Cross-border trade in services – Local presence: In SE: Suppliers of rental or leasing services of cars and certain off-road vehicles (terrängmotorfordon) without a driver, rented or leased for a period of less than one year, are obliged to appoint someone to be responsible for ensuring, among other things, that the business is conducted in accordance with applicable rules and regulations and that the road traffic safety rules are followed. The responsible person must reside in the EEA (CPC 831). Measures: SE: Lag (1998: 424) om biluthyrning (Act on renting and leasing cars). (b) Rental or leasing services and other business services related to aviation With respect to Investment liberalisation - Market access, National treatment, Most-favoured nation treatment, and Cross-border trade in services - Market access, National treatment, Most-favoured-nation treatment: The EU: For rental or leasing of aircraft without crew (dry lease), aircraft used by an air carrier of the Union are subject to applicable aircraft registration requirements. A dry lease agreement to which a Union carrier is a party shall be subject to requirements in the Union or national law on aviation safety, such as prior approval and other conditions applicable to the use of third countries' registered aircraft. To be registered, aircraft may be required to be owned either by natural persons meeting specific nationality criteria or by enterprises meeting specific criteria regarding ownership of capital and control (CPC 83104). With respect to computer reservation system (CRS) services, where Union air carriers are not accorded, by CRS services suppliers operating outside the Union, equivalent (meaning non-discriminatory) treatment to the treatment provided by Union CRS service suppliers to air carriers of a third country in the Union, or where Union CRS services suppliers are not accorded, by non-Union air carriers, equivalent treatment to the treatment provided by air carriers in the Union to CRS service suppliers of a third country, measures may be taken to accord the equivalent discriminatory treatment, respectively, to the non-Union air carriers by the CRS services suppliers operating in the Union, or to the non-Union CRS services suppliers by Union air carriers. Measures: EU: Regulation (EC) No 1008/2008 of the European Parliament and of the Council (6); and Regulation (EC) No 80/2009 of the European Parliament and of the Council (7). With respect to Investment liberalisation - National treatment and Cross-border trade in services - Market access, National treatment In BE: Private (civil) aircraft belonging to natural persons who are not nationals of a member state of the EEA may only be registered if they are domiciled or resident in Belgium without interruption for at least one year. Private (civil) aircraft belonging to foreign legal entities not formed in accordance with the law of a member state of the EEA may only be registered if they have a seat of operations, an agency or an office in Belgium without interruption for at least one year (CPC 83104). Authorisation procedures for aerial fire-fighting, flight training, spraying, surveying, mapping, photography, and other airborne agricultural, industrial and inspection services. Measures: BE: Arrêté Royal du 15 mars 1954 réglementant la navigation aérienne. (c) Services related to management consulting – arbitration and conciliation services (CPC 86602) With respect to Cross-border trade in services –National treatment, Local presence: In BG: For mediation services, permanent or long-term residency in the republic of Bulgaria is required for citizens of countries other than a member state of the EEA or the Swiss Confederation. In HU: A notification, for admission into the register, to the minister responsible for justice is required for the pursuit of mediation (such as conciliation) activities. Measures: BG: Mediation Act, Art. 8. HU: Act LV of 2002 on Mediation. (d) Technical testing and analysis services (CPC 8676) With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In CY: The provision of services by chemists and biologists requires nationality of a Member State. In FR: The professions of biologist are reserved for natural persons, EEA nationality required. Measures: CY: Registration of Chemists Law of 1988 (Law 157/1988), as amended. FR: Code de la Santé Publique. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Local presence: In BG: Establishment in Bulgaria according to the Bulgarian Commercial Act and registration in the Commercial register is required for provision of technical testing and analysis services. For the periodical inspection for proof of technical condition of road transport vehicles, the person should be registered in accordance with the Bulgarian Commercial Act or the Non-Profit Legal Persons Act, or else be registered in another Member State of the EEA. The testing and analysis of the composition and purity of air and water may be conducted only by the Ministry of Environment and Water of Bulgaria, or its agencies in co-operation with the Bulgarian Academy of Sciences. Measures: BG: Technical Requirements towards Products Act; Measurement Act; Clean Ambient Air Act; and Water Act, Ordinance N-32 for the periodical inspection for proof of technical condition of road transport vehicles. With respect to Investment liberalisation – National treatment, Most-favoured-nation treatment and Cross-border trade in services –National treatment, Most-favoured-nation treatment, Local presence: In IT: For biologists, chemical analysts, agronomists and "periti agrari", residency and enrolment in the professional register are required. Third country nationals can enrol under condition of reciprocity. Measures: IT: Biologists, chemical analysts: Law 396/1967 on the profession of biologists; and Royal Decree 842/1928 on the profession of chemical analysts. (e) Related scientific and technical consulting services (CPC 8675) With respect to Investment liberalisation – National treatment, Most-favoured nation treatment and Cross-border trade in services –National treatment, Most-favoured-nation treatment, Local presence: In IT: Residency or professional domicile in Italy is required for enrolment in the geologists' register, which is necessary for the practice of the professions of surveyor or geologist in order to provide services relating to the exploration and the operation of mines, etc. Nationality of a Member State is required; however, foreigners may enrol under condition of reciprocity. Measures: IT: Geologists: Law 112/1963, Articles 2 and 5; D.P.R. 1403/1965, Article 1. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – National treatment, Local presence: In BG: For natural persons, nationality and residency of a Member State of the EEA or the Swiss Confederation is required in order to execute functions pertinent to geodesy, cartography and cadastral surveying. For legal entities, trade registration under the legislation of a Member State of the EEA or the Swiss Confederation is required. Measures: BG: Cadastre and Property Register Act; and Geodesy and Cartography Act. With respect to Investment liberalisation – National Treatment and Cross-border trade in services – National treatment: In CY: Nationality requirement applies for the provision of relevant services. Measures: CY: Law 224/1990 as amended. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access: In FR: For surveying, access through SEL (anonyme, à responsabilité limitée ou en commandite par actions), SCP (Société civile professionnelle), SA and SARL (sociétés anonymes, à responsabilité limitée) only. For exploration and prospecting services establishment is required. This requirement may be waived for scientific researchers, by decision of the Minister of scientific research, in agreement with the Minister of Foreign affairs. Measures: FR: Loi 46-942 du 7 mai 1946 and décret n°71-360 du 6 mai 1971. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services –National treatment, Local presence: In HR: Services of basic geological, geodetic and mining consulting as well as related environmental protection consulting services in the territory of Croatia can be carried out only jointly with or through domestic legal persons. Measures: HR: Ordinance on requirements for issuing approvals to legal persons for performing professional environmental protection activities (OG No.57/10), Arts. 32-35. (f) Services incidental to agriculture (part of CPC 88) With respect to Investment liberalisation –National treatment and Cross-border trade in services – National treatment, Most-favoured-nation treatment, Local presence: In IT: For biologists, chemical analysts, agronomists and "periti agrari", residency and enrolment in the professional register are required. Third country nationals can enrol under condition of reciprocity. Measures: IT: Biologists, chemical analysts: Law 396/1967 on the profession of biologists; and Royal Decree 842/1928 on the profession of chemical analysts. With respect to Investment liberalisation – Market access, Most-favoured-nation treatment and Cross-border trade in services – Market access, Most-favoured-nation treatment: In PT: The professions of biologist, chemical analyst and agronomist are reserved for natural persons. For third-country nationals, reciprocity regime applies in the case of engineers and technical engineers (and not a citizenship requirement). For biologists, there is not a citizenship requirement nor a reciprocity requirement. Measures: PT: Decree Law 119/92 alterado p/ Lei 123/2015, 2 set. (Ordem Engenheiros); Law 47/2011 alterado p/ Lei 157/2015, 17 set. (Ordem dos Engenheiros Técnicos); and Decree Law 183/98 alterado p/ Lei 159/2015, 18 set. (Ordem dos Biólogos). (g) Security Services (CPC 87302, 87303, 87304, 87305, 87309) With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment, Local presence: In IT: Nationality of a Member State of the European Union and residency is required in order to obtain the necessary authorisation to supply security guard services and the transport of valuables. In PT: The provision of security services by a foreign supplier on a cross-border basis is not allowed. A nationality requirement exists for specialised personnel. Measures: IT: Law on public security (TULPS) 773/1931, Articles 133-141; Royal Decree 635/1940, Article 257. PT: Law 34/2013 alterada p/ Lei 46/2019, 16 maio; and Ordinance 273/2013 alterada p/ Portaria 106/2015, 13 abril. With respect to Investment liberalisation – National treatment, Most-Favoured Nation treatment and Cross-border trade in services – Local presence: In DK: Residence requirement for individuals applying for an authorisation to provide security services. Residence is also required for managers and the majority of members of the board of a legal entity applying for an authorisation to conduct security services. However, residence for management and boards of directors is not required to the extent it follows from international agreements or orders issued by the Minister for Justice. Measures: DK: Lovbekendtgørelse 2016-01-11 nr. 112 om vagtvirksomhed. With respect to Cross-border trade in services – Local presence: In EE: Residency is required for security guards. Measures: EE: Turvaseadus (Security Act) § 21, § 22. (h) Placement Services (CPC 87201, 87202, 87203, 87204, 87205, 87206, 87209) With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment (applies to the regional level of government): In BE: In all Regions in Belgium, a company having its head office outside the EEA has to demonstrate that it supplies placement services in its country of origin. In the Walloon Region, a specific type of legal entity (régulièrement constituée sous la forme d'une personne morale ayant une forme commerciale, soit au sens du droit belge, soit en vertu du droit d'un Etat membre ou régie par celui-ci, quelle que soit sa forme juridique) is required to supply placement services. A company having its head office outside the EEA has to demonstrate that it fulfils the conditions as set out in the Decree (for instance on the type of legal entity). In the German-speaking community, a company having its head office outside the EEA has to fulfil the admission criteria established by the mentioned Decree (CPC 87202). Measures: BE: Flemish Region: Article 8, § 3, Besluit van de Vlaamse Regering van 10 december 2010 tot uitvoering van het decreet betreffende de private arbeidsbemiddeling. Walloon Region: Décret du 3 avril 2009 relatif à l'enregistrement ou à l'agrément des agences de placement (Decree of 3 April 2009 on registration of placement agencies), Article 7; and Arrêté du Gouvernement wallon du 10 décembre 2009 portant exécution du décret du 3 avril 2009 relatif à l'enregistrement ou à l'agrément des agences de placement (Decision of the Walloon Government of 10 December 2009 implementing the Decree of 3 April 2009 on registration of placement agencies), Article 4. German-speaking community: Dekret über die Zulassung der Leiharbeitsvermittler und die Überwachung der privaten Arbeitsvermittler / Décret du 11 mai 2009 relatif à l'agrément des agences de travail intérimaire et à la surveillance des agences de placement privées, Article 6. With respect to Investment liberalisation – National treatment and Cross-border trade in services –National treatment, Local presence: In DE: Nationality of a Member State of the European Union or a commercial presence in the European Union is required in order to obtain a licence to operate as a temporary employment agency pursuant to Sec. 3 paragraphs 3 to 5 of this Act on temporary agency work (Arbeitnehmerüberlassungsgesetz). The Federal Ministry of Labour and Social Affairs may issue a regulation concerning the placement and recruitment of non-EEA personnel for specified professions e.g. for health and care related professions. The licence or its extension shall be refused if establishments, parts of establishments or ancillary establishments which are not located in the EEA are intended to execute the temporary employment pursuant to Sec. 3 paragraph 2 of the Act on temporary agency work (Arbeitnehmerüberlassungsgesetz). Measures: DE: Gesetz zur Regelung der Arbeitnehmerüberlassung (AÜG); Sozialgesetzbuch Drittes Buch (SGB III; Social Code, Book Three) - Employment Promotion; Verordnung über die Beschäftigung von Ausländerinnen und Ausländern (BeschV; Ordinance on the Employment of Foreigners). With respect to Investment liberalisation – Market access: In ES: Prior to the start of the activity, placement agencies are required to submit a sworn statement certifying the fulfilment of the requirements stated by the current legislation (CPC 87201, 87202). Measures: ES: Real Decreto-ley 8/2014, de 4 de julio, de aprobación de medidas urgentes para el crecimiento, la competitividad y la eficiencia (tramitado como Ley 18/2014, de 15 de octubre). (i) Translation and interpretation services (CPC 87905) With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access: In BG: To carry out official translation activities foreign natural persons are required to hold a permit for long-term or permanent residency in the Republic of Bulgaria. Measures: BG: Regulation for the legalisation, certification and translation of documents. With respect to Investment liberalisation – Market access and Cross-border trade in services – Market access: In HU: Official translations, official certifications of translations, and certified copies of official documents in foreign languages may only be provided by the Hungarian Office for Translation and Attestation (OFFI). In PL: Only natural persons may be sworn translators. Measures: HU: Decree of the Council of Ministers No. 24/1986 on Official translation and interpretation. PL: Act of 25 November 2004 on the profession of sworn translator or interpreter (Journal of Laws from 2019 item 1326). With respect to Cross-border trade in services –Market Access: In FI: Residency in the EEA is required for certified translators. Measures: FI: Laki auktorisoiduista kääntäjistä (Act on Authorised Translators) (1231/2007), s. 2(1). With respect to Investment liberalisation – National treatment and Cross-border trade in services – National treatment: In CY: Registration to registry of translators is necessary for the provision of official translation and certification services. Nationality requirement applies. In HR: EEA nationality is required for certified translators. Measures: CY: The Establishment, Registration and Regulation of the Certified Translator Services in the Republic of Cyprus Law. HR: Ordinance on permanent court interpreters (OG 88/2008), Article 2. (j) Other business services (part of CPC 612, part of 621, part of 625, 87901, 87902, 88493, part of 893, part of 85990, 87909, ISIC 37) With respect to Investment liberalisation – Market access: In SE: Pawn-shops must be established as a limited liability company or as a branch (part of CPC 87909). With respect to Investment liberalisation – Market access, and Cross-border trade in services – Local presence: In CZ: Only an authorised package company is allowed to supply services relating to packaging take-back and recovery and must be a legal person established as a joint-stock company (CPC 88493, ISIC 37). With respect to Investment liberalisation – Market access, and Cross-border trade in services – Market access: In NL: To provide hallmarking services, commercial presence in the Netherlands is required. The hallmarking of precious metal Articles is currently exclusively granted to two Dutch public monopolies (part of CPC 893). Measures: CZ: Act. 477/2001 Coll. (Packaging Act) paragraph 16. SE: Pawn shop act (1995:1000). NL: Waarborgwet 1986. With respect to Investment liberalisation – Market Access, National Treatment: In PT: Nationality of a Member State is required for the provision of collection agency services and credit reporting services (CPC 87901, 87902). Measures: PT: Law 49/2004. With respect to Investment liberalisation – Market access, National Treatment and Cross-border trade in services – Local presence: In CZ: Auction services are subject to licence. To obtain a licence (for the supply of voluntary public auctions), a company must be incorporated in the Czech Republic and a natural person is required to obtain a residency permit, and the company, or natural person must be registered in the Commercial Register of the Czech Republic (part of CPC 612, part of 621, part of 625, part of 85990). Measures: CZ: Act no.455/1991 Coll.; Trade Licence Act; and Act no. 26/2000 Coll., on public auctions. With respect to Cross-border trade in services –Market access: In SE: The economic plan for a building society must be certified by two persons. These persons must be publicly approved by authorities in the EEA (CPC 87909). Measures: SE: Cooperative building societies law (1991:614). Reservation No. 7 - Communication services Sector – sub-sector: Communication services - postal and courier services Industry classification: Part of CPC 71235, part of 73210, part of 751 Type of reservation: Market access Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: With respect to Investment liberalisation - Market access and Cross-border trade in services - Market access: The EU: The organisation of the siting of letter boxes on the public highway, the issuing of postage stamps and the provision of the registered mail service used in the course of judicial or administrative procedures may be restricted in accordance with national legislation. Licensing systems may be established for those services for which a general universal service obligation exists. These licences may be subject to particular universal service obligations or a financial contribution to a compensation fund. Measures: EU: Directive 97/67/EC of the European Parliament and of the Council (8). Reservation No. 8 - Construction Services Sector – sub-sector: Construction and related engineering services Industry classification: CPC 51 Type of reservation: National treatment Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: In CY: Nationality requirement. Measure: The Registration and Control of Contractors of Building and Technical Works Law of 2001 (29 (I) / 2001), Articles 15 and 52. Reservation No. 9 - Distribution services Sector – sub-sector: Distribution services – general, distribution of tobacco Industry classification: CPC 3546, part of 621, 6222, 631, part of 632 Type of reservation: Market access National treatment Local presence Chapter: Investment liberalisation; Cross-Border trade in services Level of government: EU/Member State (unless otherwise specified) Description: (a) Distribution services (CPC 3546, 631, 632 except 63211, 63297, 62276, part of 621) With respect to Investment liberalisation – Market access: In PT: A specific authorisation scheme exists for the installation of certain retail establishments and shopping centres. This relates to shopping centres that have a gross leasable area equal or greater than 8,000 m2, and retail establishments having a sales area equal or exceeding 2,000 m2, when located outside shopping centres. Main criteria: Contribution to a multiplicity of commercial offers; assessment of services to consumer; quality of employment and corporate social responsibility; integration in urban environment; contribution to eco-efficiency (CPC 631, 632 except 63211, 63297). Measures: PT: Decree-Law No. 10/2015, 16 January. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In CY: Nationality requirement exists for distribution services provided by pharmaceutical representatives (CPC 62117). Measures: CY: Law 74(I) 2020 as amended. With respect to Investment liberalisation – Market access and Cross-border trade in services – Local presence: In LT: The distribution of pyrotechnics is subject to licensing. Only legal persons of the Union may obtain a licence (CPC 3546). Measures: LT: Law on Supervision of Civil Pyrotechnics Circulation (23 March 2004. No. IX-2074). (b) Distribution of tobacco (part of CPC 6222, 62228, part of 6310, 63108) With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In ES: There is a state monopoly on retail sales of tobacco. Establishment is subject to a Member State nationality requirement. Only natural persons may operate as a tobacconist. Each tobacconist cannot obtain more than one license (CPC 63108). In FR: State monopoly on wholesale and retail sales of tobacco. Nationality requirement for tobacconists (buraliste) (part of CPC 6222, part of 6310). Measures: ES: Law 14/2013 of 27 September 2014. FR: Code général des impôts. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In AT: Only natural persons may apply for an authorisation to operate as a tobacconist. Priority is given to nationals of a Member State of the EEA (CPC 63108). Measures: AT: Tobacco Monopoly Act 1996, § 5 and § 27. With respect to Investment liberalisation – Market access and Cross-border trade in services – Market access, National treatment: In IT: In order to distribute and sell tobacco, a licence is needed. The licence is granted through public procedures. The granting of licences is subject to an economic needs test. Main criteria: population and geographical density of existing selling points (part of CPC 6222, part of 6310). Measures: IT: Legislative Decree 184/2003; Law 165/1962; Law 3/2003; Law 1293/1957; Law 907/1942; and Decree of the President of the Republic (D.P.R.) 1074/1958. Reservation No. 10 - Education services Sector – sub-sector: Education services (privately funded) Industry classification: CPC 921, 922, 923, 924 Type of reservation: Market access National treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access: In CY: Nationality of a Member State is required for owners and majority shareholders in a privately funded school. Nationals of the United Kingdom may obtain authorisation from the Minister (of Education) in accordance with the specified form and conditions. Measures: CY: Private Schools Law of 2019 (N. 147(I)/2019) With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In BG: Privately funded primary and secondary education services may only be supplied by authorised Bulgarian enterprises (commercial presence is required). Bulgarian kindergartens and schools having foreign participation may be established or transformed at the request of associations, or corporations, or enterprises of Bulgarian and foreign natural or legal entities, duly registered in Bulgaria, by decision of the Council of Ministers on a motion by the Minister of Education and Science. Foreign owned kindergartens and schools may be established or transformed at the request of foreign legal entities in accordance with international agreements and conventions and under the provisions above. Foreign higher education institutions cannot establish subsidiaries in the territory of Bulgaria. Foreign higher education institutions may open faculties, departments, institutes and colleges in Bulgaria only within the structure of Bulgarian high schools and in cooperation with them (CPC 921, 922). Measures: BG: Pre-school and School Education Act; and Law for the Higher Education, paragraph 4 of the additional provisions. With respect to Investment liberalisation – Market access, National treatment In SI: Privately funded elementary schools may be founded by Slovenian natural or legal persons only. The service supplier must establish a registered office or branch office (CPC 921). Measures: SI: Organisation and Financing of Education Act (Official Gazette of Republic of Slovenia, no. 12/1996) and its revisions, Article 40. With respect to Cross-border services – Local presence: In CZ and SK: Establishment in a Member State is required to apply for state approval to operate as a privately funded higher education institution. This reservation does not apply to post-secondary technical and vocational education services (CPC 92310). Measures: CZ: Act No. 111/1998, Coll. (Higher Education Act), § 39; and Act No. 561/2004 Coll. on Pre-school, Basic, Secondary, Tertiary Professional and Other Education (the Education Act). SK: Law No. 131/2002 on Universities. With respect to Investment liberalisation – Market access and Cross-border services: Market access: In ES and IT: An authorisation is required in order to open a privately funded university which issues recognised diplomas or degrees. An economic needs test is applied. Main criteria: population and density of existing establishments. In ES: The procedure involves obtaining the advice of the Parliament. In IT: This is based on a three-year programme and only Italian legal persons may be authorised to issue state-recognised diplomas (CPC 923). Measures: ES: Ley Orgánica 6/2001, de 21 de Diciembre, de Universidades (Law 6 / 2001 of 21 December, on Universities), Article 4. IT: Royal Decree 1592/1933 (Law on secondary education); Law 243/1991 (Occasional public contribution for private universities); Resolution 20/2003 of CNVSU (Comitato nazionale per la valutazione del sistema universitario); and Decree of the President of the Republic (DPR) 25/1998. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access: In EL: Nationality of a Member State is required for owners and a majority of the members of the board of directors in privately funded primary and secondary schools, and for teachers in privately funded primary and secondary education (CPC 921, 922). Education at university level shall be provided exclusively by institutions which are fully self-governed public law legal persons. However, Law 3696/2008 permits the establishment by Union residents (natural or legal persons) of private tertiary education institutions granting certificates which are not recognised as being equivalent to university degrees (CPC 923). Measures: EL: Laws 682/1977, 284/1968, 2545/1940, Presidential Degree 211/1994 as amended by Presidential Degree 394/1997, Constitution of Hellas, Article 16, paragraph 5 and Law 3549/2007. With respect to Investment liberalisation – Market access and Cross-border trade in services – Market access: In AT: The provision of privately funded university level education services in the area of applied sciences requires an authorisation from the competent authority, the AQ Austria (Agency for Quality Assurance and Accreditation Austria). An investor seeking to provide such services must have his primary business being the supply of such services, and must submit a needs assessment and a market survey for the acceptance of the proposed study programme. The competent Ministry may deny the approval if the decision of the accreditation authority does not comply with national educational interests. The applicant for a private university requires an authorisation from the competent authority (AQ Austria - Agency for Quality Assurance and Accreditation Austria). The competent Ministry may deny the approval if the decision of the accreditation authority does not comply with national educational interests (CPC 923). Measures: AT: University of Applied Sciences Studies Act, BGBl. I Nr. 340/1993 as amended, § 2, 8; Private Higher Education Institution Act, BGBl. I Nr. 77/2020, § 2; and Act on Quality Assurance in Higher Education, BGBl. Nr. 74/2011 as amended, § 25 (3). With respect to Investment liberalisation – Market access, National treatment, Most-favoured nation treatment and Cross-border trade in services – Market access, National treatment: In FR: Nationality of a Member State is required in order to teach in a privately funded educational institution (CPC 921, 922, 923). However, nationals of the United Kingdom may obtain an authorisation from the relevant competent authorities in order to teach in primary, secondary and higher level educational institutions. Nationals of the United Kingdom may also obtain an authorisation from the relevant competent authorities in order to establish and operate or manage primary, secondary or higher level educational institutions. Such authorisation is granted on a discretionary basis. Measures: FR: Code de l'éducation. With respect to Investment – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In MT: Service suppliers seeking to provide privately funded higher or adult education services must obtain a licence from the Ministry of Education and Employment. The decision on whether to issue a licence may be discretionary (CPC 923, 924). Measures: MT: Legal Notice 296 of 2012. Reservation No. 11 - Environmental services Sector – sub-sector: Environmental services – processing and recycling of used batteries and accumulators, old cars and waste from electrical and electronic equipment; protection of ambient air and climate cleaning services of exhaust gases Industry classification: Part of CPC 9402, 9404 Type of reservation: Local presence Chapter: Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: In SE: Only entities established in Sweden or having their principal seat in Sweden are eligible for accreditation to perform control services of exhaust gas (CPC 9404). In SK: For processing and recycling of used batteries and accumulators, waste oils, old cars and waste from electrical and electronic equipment, incorporation in the EEA is required (residency requirement) (part of CPC 9402). Measures: SE: The Vehicles Act (2002:574). SK: Act 79/2015 on Waste. Reservation No. 12 – Financial Services Sector – sub-sector: Financial services – insurance and banking Industry classification: Not applicable Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: (a) Insurance and Insurance-related Services With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In IT: Access to the actuarial profession through natural persons only. Professional associations (no incorporation) among natural persons permitted. European Union nationality is required for the practice of the actuarial profession, except for foreign professionals who may be allowed to practice based on reciprocity. Measures: IT: Article 29 of the code of private insurance (Legislative decree no. 209 of 7 September 2005); and Law 194/1942, Article 4, Law 4/1999 on the register. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Local presence: In BG: Pension insurance shall be carried out as a joint-stock company licensed in accordance with the Code of Social Insurance and registered under the Commerce Act or under the legislation of another Member State of the EU (no branches). In BG, ES, PL and PT: Direct branching is not permitted for insurance intermediation, which is reserved to companies formed in accordance with the law of a Member State (local incorporation is required). For PL, residency requirement for insurance intermediaries. Measures: BG: Insurance Code, articles 12, 56-63, 65, 66 and 80 paragraph 4, Social Insurance Code Art. 120a–162, Art. 209–253, Art. 260–310. ES: Reglamento de Ordenación, Supervisión y Solvencia de Entidades Aseguradoras y Reaseguradoras (RD 1060/2015, de 20 de noviembre de 2015), article 36. PL: Act on insurance and reinsurance activity of September 11, 2015 (Journal of Laws of 2020, item 895 and 1180); Act on insurance distribution of December 15, 2017 (Journal of Laws 2019, item 1881); Act on the organization and operation of pension funds of August 28, 1997 (Journal of Laws of 2020, item 105); Act of 6 March 2018 on rules regarding economic activity of foreign entrepreneurs and other foreign persons in the territory of the Republic of Poland. PT: Article 7 of Decree-Law 94-B/98 revoked by Decree-Law 2/2009, January 5th; and chapter I, Section VI of Decree-Law 94-B/98, articles 34, nr. 6, 7, and article 7 of Decree-Law 144/2006, revoked by Law 7/2019, January 16th. Article 8 of the legal regime governing the business of insurance and reinsurance distribution, approved by Law 7/2019, of January 16th. With respect to Investment liberalisation – National treatment: In AT: The management of a branch office must consist of at least two natural persons resident in AT. In BG: Residency requirement for the members of managing and supervisory body of (re)insurance undertakings and every person authorised to manage or represent the (re)insurance undertaking. The Chairperson of the Management Board, the Chairperson of the Board of Directors, the Executive Director and the Managerial Agent of pension insurance companies must have a permanent address or hold a durable residence permit in Bulgaria. Measures: AT: Insurance Supervision Act 2016, Article 14 para. 1 no. 3, Federal Law Gazette I No. 34/2015 (Versicherungsaufsichtsgesetz 2016, § 14 Abs. 1 Z 3, BGBl. I Nr. 34/2015) BG: Insurance Code, articles 12, 56-63, 65, 66 and 80 paragraph 4, Social Insurance Code, Art. 120a–162, Art. 209–253, Art. 260–310 With respect to Investment liberalisation – Market access, National treatment: In BG: Before establishing a branch or agency to provide insurance, a foreign insurer or reinsurer must have been authorised to operate in its country of origin in the same classes of insurance as those it wishes to provide in BG. The income of the supplementary voluntary pension funds, as well as similar income directly connected with voluntary pension insurance, carried out by persons who are registered under the legislation of another Member State and who may, in compliance with the legislation concerned, perform voluntary pension insurance operations, shall not be taxable according to the procedure established by the Corporate Income Tax Act. In ES: Before establishing a branch or agency in Spain in order to provide certain classes of insurance, a foreign insurer must have been authorised to operate in the same classes of insurance in its country of origin for at least five years. In PT: In order to establish a branch or agency, foreign insurance undertakings must have been authorised to carry out the business of insurance or reinsurance, according to the relevant national law for at least five years. Measures: BG: Insurance Code, articles 12, 56-63, 65, 66 and 80 paragraph 4, Social Insurance Code, Art. 120a–162, Art. 209–253, Art. 260–310. ES: Reglamento de Ordenación, Supervisión y Solvencia de Entidades Aseguradoras y Reaseguradoras (RD 1060/2015, de 20 de noviembre de 2015), article 36. PT: Article 7 of Decree-Law 94-B/98 and chapter I, Section VI of Decree-Law 94-B/98, articles 34, nr. 6, 7, and article 7 of Decree-Law 144/2006; Article 215 of legal regime governing the taking up and pursuit of the business of insurance and reinsurance, approved by Law 147/2005, of September 9th. With respect to Investment liberalisation – Market access: In AT: In order to obtain a licence to open a branch office, foreign insurers must have a legal form corresponding or comparable to a joint stock company or a mutual insurance association in their home country. In EL: Insurance and reinsurance undertakings with head offices in third countries may operate in Greece via establishing a subsidiary or a branch, where branch in this case does not take any specific legal form, as it means a permanent presence in the territory of a Member State (i.e. Greece) of an undertaking with head office outside EU, which receives authorisation in that Member State (Greece) and which pursues insurance business. Measures: AT: Insurance Supervision Act 2016, Article 14 para. 1 no. 1, Federal Law Gazette I No. 34/2015 (Versicherungsaufsichtsgesetz 2016, § 14 Abs. 1 Z 1, BGBl. I Nr. 34/2015). EL: Art. 130 of the Law 4364/ 2016 (Gov. Gazette 13/ A/ 05.02.2016). With respect to Cross-border trade in services – National treatment, Local presence: In AT: Promotional activity and intermediation on behalf of a subsidiary not established in the Union or of a branch not established in AT (except for reinsurance and retrocession) are prohibited. In DK: No persons or companies (including insurance companies) may, for business purposes, assist in effecting direct insurance for persons resident in DK, for Danish ships or for property in DK, other than insurance companies licensed by Danish law or by Danish competent authorities. In SE: The supply of direct insurance by a foreign insurer is allowed only through the mediation of an insurance service supplier authorised in Sweden, provided that the foreign insurer and the Swedish insurance company belong to the same group of companies or have an agreement of cooperation between them. With respect to Cross-border trade in services – Local presence: In DE, HU and LT: The supply of direct insurance services by insurance companies not incorporated in the European Union requires the setting up and authorisation of a branch. In SE: The provision of insurance intermediation services by undertakings not incorporated in the EEA requires the establishment of a commercial presence (local presence requirement). In SK: Air and maritime transport insurance, covering the aircraft/vessel and responsibility, can be underwritten only by insurance companies established in the Union or by the branch office of the insurance companies not established in the Union authorised in the Slovak Republic. Measures AT: Insurance Supervision Act 2016, Article 13 para. 1 and 2, Federal Law Gazette I No. 34/2015 (Versicherungsaufsichtsgesetz 2016, § 13 Abs. 1 und 2, BGBl. I Nr. 34/2015) DE: Versicherungsaufsichtsgesetz (VAG) for all insurance services; in connection with Luftverkehrs-Zulassungs-Ordnung (LuftVZO) only for compulsory air liability insurance. DK: Lov om finansiel virksomhed jf. lovbekendtgørelse 182 af 18. februar 2015. HU: Act LX of 2003. LT: Law on Insurance, 18 of September, 2003 m. Nr. IX-1737, last amendment 13 of June 2019 Nr. XIII-2232. SE: Lag om försäkringsförmedling (Insurance Distribution Mediation Act) (Chapter 3, section 3, 2018:12192005:405); and Foreign Insurers Business in Sweden Act (Chapter 4, section 1 and 10, 1998:293). SK: Act 39/2015 on insurance. (b) Banking and other financial services With respect to Investment liberalisation – Market Access, National treatment, and Cross-border trade in services – Local presence: In BG: For pursuing the activities of lending with funds which are not raised through taking of deposits or other repayable funds, acquiring holdings in a credit institution or another financial institution, financial leasing, guarantee transactions, acquisition of claims on loans and other forms of financing (factoring, forfeiting, etc.), non-bank financial institutions are subject to registration regime with the Bulgarian National Bank. The financial institution shall have its main business in the territory of Bulgaria. In BG: Non-EEA banks may pursue banking activity in Bulgaria after obtaining a license from BNB for taking up and pursuing of business activities in the Republic of Bulgaria through a branch. In IT: In order to be authorised to operate the securities settlement system or to provide central securities depository services with an establishment in Italy, a company is required to be incorporated in Italy (no branches). In the case of collective investment schemes other than undertakings for collective investment in transferable securities ("UCITS") harmonised under Union legislation, the trustee or depository is required to be established in Italy or in another Member State and have a branch in Italy. Management enterprises of investment funds not harmonised under Union legislation are also required to be incorporated in Italy (no branches). Only banks, insurance enterprises, investment firms and enterprises managing UCITS harmonised under Union legislation having their legal head office in the Union, as well as UCITS incorporated in Italy, may carry out the activity of pension fund resource management. In providing the activity of door-to-door selling, intermediaries must utilise authorised financial salesmen resident within the territory of a Member State. Representative offices of non-European Union intermediaries cannot carry out activities aimed at providing investment services, including trading for own account and for the account of customers, placement and underwriting financial instruments (branch required). In PT: Pension fund management may be provided only by specialised companies incorporated in PT for that purpose and by insurance companies established in PT and authorised to take up life insurance business, or by entities authorised to provide pension fund management in other Member States. Direct branching from non-European Union countries is not permitted. Measures: BG: Law on Credit Institutions, article 2, paragraph 5, article 3a and article 17 Code of Social Insurance, articles 121, 121b, 121f; and Currency Law, article 3. IT: Legislative Decree 58/1998, articles 1, 19, 28, 30-33, 38, 69 and 80; Joint Regulation of Bank of Italy and Consob 22.2.1998, articles 3 and 41; Regulation of Bank of Italy 25.1.2005; Title V, Chapter VII, Section II, Consob Regulation 16190 of 29.10.2007, articles 17-21, 78-81, 91-111; and subject to: Regulation (EU) No 909/2014 of the European Parliament and of the Council (9). PT: Decree-Law 12/2006, as amended by Decree-Law 180/2007 Decree-Law 357-A/2007, Regulation 7/2007-R, as amended by Regulation 2/2008-R, Regulation 19/2008-R, Regulation 8/2009. Article 3 of the legal regime governing the establishment and functioning of pension funds and their management entities approved by Law 27/2020, of July 23rd. With respect to Investment liberalisation – Market access, National treatment: In HU: Branches of non-EEA investment fund management companies may not engage in the management of European investment funds and may not provide asset management services to private pension funds. Measures: HU: Act CCXXXVII of 2013 on Credit Institutions and Financial Enterprises; and Act CXX of 2001 on the Capital Market. With respect to Investment liberalisation – National Treatment and Cross-border trade in services – Market access: In BG: А bank shall be managed and represented jointly by at least two persons. The persons who manage and represent the bank shall be personally present at its management address. Legal persons may not be elected members of the managing board or the board of directors of a bank. In SE: A founder of a savings bank shall be a natural person. Measures: BG: Law on Credit Institutions, article 10; Code Of Social Insurance, article 121e; and Currency Law, article 3. SE: Sparbankslagen (Savings Bank Act) (1987:619), Chapter 2, § 1. With respect to Investment liberalisation – National treatment: In HU: The board of directors of a credit institution shall have at least two members recognised as resident according to foreign exchange regulations and having had prior permanent residence in HU for at least one year. Measures: HU: Act CCXXXVII of 2013 on Credit Institutions and Financial Enterprises; and Act CXX of 2001 on the Capital Market. With respect to Investment liberalisation – Market access: In RO: Market operators are legal persons set up as joint stock companies according to the provisions of the Company law. Alternative trading systems (Multilateral trading facility (MTF) pursuant to MiFID II Directive) can be managed by a system operator set up under the conditions described above or by an investment firm authorised by ASF (Autoritatea de Supraveghere Financiară – Financial Supervisory Authority). In SI: A pension scheme may be provided by a mutual pension fund (which is not a legal entity and is therefore managed by an insurance company, a bank or a pension company), a pension company or an insurance company. Additionally, a pension scheme can also be offered by pension scheme providers established in accordance with the regulations applicable in a Member State of the EU. Measures: RO: Law no. 126 of 11 June 2018 regarding financial instruments and Regulation no. 1/2017 for the amendment and supplement of Regulation no. 2/2006 on regulated markets and alternative trading systems, approved by Order of NSC no. 15/2006 - ASF – Autoritatea de Supraveghere Financiară – Financial Supervisory Authority. SI: Pension and Disability Insurance Act, (Official Gazette no. 102/2015 (as last amended No 28/19). With respect to Cross-border trade in services – Local presence: In HU: Non-EEA companies may provide financial services or engage in activities auxiliary to financial services solely through a branch in HU. Measures: HU: Act CCXXXVII of 2013 on Credit Institutions and Financial Enterprises; and Act CXX of 2001 on the Capital Market. Reservation No. 13 - Health services and social services Sector – sub-sector: Health services and social services Industry classification: CPC 931, 933 Type of reservation: Market access National treatment Chapter: Investment liberalisation and Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: With respect to Investment liberalisation – Market access: In DE: (applies also to the regional level of government): Rescue services and "qualified ambulance services" are organised and regulated by the Länder. Most Länder delegate competences in the field of rescue services to municipalities. Municipalities are allowed to give priority to not-for-profit operators. This applies equally to foreign as well as domestic service suppliers (CPC 931, 933). Ambulance services are subject to planning, permission and accreditation. Regarding telemedicine, the number of ICT (information and communications technology) service suppliers may be limited to guarantee interoperability, compatibility and necessary safety standards. This is applied in a non-discriminatory way. In HR: Establishment of some privately funded social care facilities may be subject to needs based limits in particular geographical areas (CPC 9311, 93192, 93193, 933). In SI: a state monopoly is reserved for the following services: Supply of blood, blood preparations, removal and preservation of human organs for transplant, socio-medical, hygiene, epidemiological and health-ecological services, patho-anatomical services, and biomedically-assisted procreation (CPC 931). Measures: DE: Bundesärzteordnung (BÄO; Federal Medical Regulation): Gesetz über die Ausübung der Zahnheilkunde (ZHG); Gesetz über den Beruf der Psychotherapeutin und des Psychotherapeuten (PsychThG; Act on the Provision of Psychotherapy Services); Gesetz über die berufsmäßige Ausübung der Heilkunde ohne Bestallung (Heilpraktikergesetz); Gesetz über das Studium und den Beruf der Hebammen (HebG); Gesetz über den Beruf der Notfallsanitäterin und des Notfallsanitäters (NotSanG); Gesetz über die Pflegeberufe (PflBG); Gesetz über die Berufe in der Physiotherapie (MPhG); Gesetz über den Beruf des Logopäden (LogopG); Gesetz über den Beruf des Orthoptisten und der Orthoptistin (OrthoptG); Gesetz über den Beruf der Podologin und des Podologen (PodG); Gesetz über den Beruf der Diätassistentin und des Diätassistenten (DiätAssG); Gesetz über den Beruf der Ergotherapeutin und des Ergotherapeuten (ErgThg); Bundesapothekerordnung (BapO); Gesetz über den Beruf des pharmazeutisch-technischen Assistenten (PTAG); Gesetz über technische Assistenten in der Medizin (MTAG); Gesetz zur wirtschaftlichen Sicherung der Krankenhäuser und zur Regelung der Krankenhauspflegesätze (Krankenhausfinanzierungsgesetz - KHG); Gewerbeordnung (German Trade, Commerce and Industry Regulation Act); Sozialgesetzbuch Fünftes Buch (SGB V; Social Code, Book Five) - Statutory Health Insurance; Sozialgesetzbuch Sechstes Buch (SGB VI; Social Code, Book Six) - Statutory Pension Insurance; Sozialgesetzbuch Siebtes Buch (SGB VII; Social Code, Book Seven) - Statutory Accident Insurance; Sozialgesetzbuch Neuntes Buch (SGB IX; Social Code, Book Nine) - Rehabilitation and Participation of Persons with Disabilities; Sozialgesetzbuch Elftes Buch (SGB XI; Social Code, Book Eleven) - Social Assistance. Personenbeförderungsgesetz (PBefG; Act on Public Transport). Regional level: Gesetz über den Rettungsdienst (Rettungsdienstgesetz - RDG) in Baden-Württemberg; Bayerisches Rettungsdienstgesetz (BayRDG); Gesetz über den Rettungsdienst für das Land Berlin (Rettungsdienstgesetz); Gesetz über den Rettungsdienst im Land Brandenburg (BbgRettG); Bremisches Hilfeleistungsgesetz (BremHilfeG); Hamburgisches Rettungsdienstgesetz (HmbRDG); Gesetz über den Rettungsdienst für das Land Mecklenburg-Vorpommern (RDGM-V); Niedersächsisches Rettungsdienstgesetz (NRettDG); Gesetz über den Rettungsdienst sowie die Notfallrettung und den Krankentransport durch Unternehmer (RettG NRW); Landesgesetz über den Rettungsdienst sowie den Notfall- und Krankentransport (RettDG); Saarländisches Rettungsdienstgesetz (SRettG); Sächsisches Gesetz über den Brandschutz, Rettungsdienst und Katastrophenschutz (SächsBRKG); Rettungsdienstgesetz des Landes Sachsen-Anhalt (RettDG LSA); Schleswig-Holsteinisches Rettungsdienstgesetz (SHRDG); Thüringer Rettungsdienstgesetz (ThüRettG). Landespflegegesetze: Gesetz zur Umsetzung der Pflegeversicherung in Baden-Württemberg (Landespflegegesetz - LPflG); Gesetz zur Ausführung der Sozialgesetze (AGSG); Gesetz zur Planung und Finanzierung von Pflegeeinrichtungen (Landespflegeeinrichtungsgesetz- LPflegEG); Gesetz über die pflegerische Versorgung im Land Brandenburg (Landespflegegesetz - LPflegeG); Gesetz zur Ausführung des Pflege-Versicherungsgesetzes im Lande Bremen und zur Änderung des Bremischen Ausführungsgesetzes zum Bundessozialhilfegesetz (BremAGPflegeVG); Hamburgisches Landespflegegesetz (HmbLPG); Hessisches Ausführungsgesetz zum Pflege-Versicherungsgesetz; Landespflegegesetz (LPflegeG M-V); Gesetz zur Planung und Förderung von Pflegeeinrichtungen nach dem Elften Buch Sozialgesetzbuch (Niedersächsisches Pflegegesetz - NPflegeG); Gesetz zur Weiterentwicklung des Landespflegerechts und Sicherung einer unterstützenden Infrastruktur für ältere Menschen, pflegebedürftige Menschen und deren Angehörige (Alten- und Pflegegesetz Nordrhein-Westfalen – APG NRW); Landesgesetz zur Sicherstellung und Weiterentwicklung der pflegerischen Angebotsstruktur (LPflegeASG) (Rheinland-Pfalz); Gesetz Nr. 1694 zur Planung und Förderung von Angeboten für hilfe-, betreuungs- oder pflegebedürftige Menschen im Saarland (Saarländisches Pflegegesetz); Sächsisches Pflegegesetz (SächsPflegeG); Schleswig-Holstein: Ausführungsgesetz zum Pflege-Versicherungsgesetz (Landespflegegesetz - LPflegeG); Thüringer Gesetz zur Ausführung des Pflege-Versicherungsgesetzes (ThürAGPflegeVG). Landeskrankenhausgesetz Baden-Württemberg; Bayerisches Krankenhausgesetz (BayKrG); Berliner Gesetz zur Neuregelung des Krankenhausrechts; Krankenhausentwicklungsgesetz Brandenburg (BbgKHEG); Bremisches Krankenhausgesetz (BrmKrHG); Hamburgisches Krankenhausgesetz (HmbKHG); Hessisches Krankenhausgesetz 2011 (HKHG 2011); Krankenhausgesetz für das Land Mecklenburg-Vorpommern (LKHG M-V); Niedersächsisches Krankenhausgesetz (NKHG); Krankenhausgestaltungsgesetz des Landes Nordrhein-Westfalen (KHGG NRW); Landeskrankenhausgesetz Rheinland-Pfalz (LKG Rh-Pf); Saarländisches Krankenhausgesetz (SKHG); Gesetz zur Neuordnung des Krankenhauswesens (Sächsisches Krankenhausgesetz - SächsKHG); Krankenhausgesetz Sachsen-Anhalt (KHG LSA); Gesetz zur Ausführung des Krankenhausfinanzierungsgesetzes (AG-KHG) in Schleswig-Holstein; Thüringisches Krankenhausgesetz (Thür KHG). HR: Health Care Act (OG 150/08, 71/10, 139/10, 22/11, 84/11, 12/12, 70/12, 144/12). SI: Law of Health Services, Official Gazette of the RS, No. 23/2005, Articles 1, 3 and 62-64; Infertility Treatment and Procedures of the Biomedically-Assisted Procreation Act, Official Gazette of the RS, No. 70/00, Articles 15 and 16; and Supply of Blood Act (ZPKrv-1), Official Gazette of RS, no. 104/06, Articles 5 and 8. With respect to Investment liberalisation – Market access, National treatment: In FR: For hospital and ambulance services, residential health facilities (other than hospital services) and social services, an authorisation is necessary in order to exercise management functions. The authorisation process takes into account the availability of local managers. Companies can take any legal forms, except those reserved to liberal professions. Measures: FR: Loi 90-1258 relative à l'exercice sous forme de société des professions libérales, Loi n°2011-940 du 10 août 2011 modifiant certaines dipositions de la loi n°2009-879 dite HPST, Loi n°47-1775 portant statut de la coopération; and Code de la santé publique. Reservation No. 14 - Tourism and travel related services Sector – sub-sector: Tourism and travel related services - hotels, restaurants and catering; travel agencies and tour operators services (including tour managers); tourist guides services Industry classification: CPC 641, 642, 643, 7471, 7472 Type of reservation: Market access National treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access, National treatment: In BG: Incorporation (no branches) is required. Tour operation or travel agency services may be provided by a person established in the EEA if, upon establishment in the territory of Bulgaria, the said person presents a copy of a document certifying the right thereof to practice that activity and a certificate or another document issued by a credit institution or an insurer containing data of the existence of insurance covering the liability of the said person for damage which may ensue as a result of a culpable non-fulfilment of professional duties. The number of foreign managers may not exceed the number of managers who are Bulgarian nationals, in cases where the public (state or municipal) share in the equity capital of a Bulgarian company exceeds 50 per cent. EEA nationality requirement for tourist guides (CPC 641, 642, 643, 7471, 7472). Measures: BG: Law for Tourism, Articles 61, 113 and 146. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment, Local presence: In CY: A licence to establish and operate a tourism and travel company or agency, as well as the renewal of an operating licence of an existing company or agency, shall be granted only to European Union natural or legal persons. No non-resident company except those established in another Member State, can provide in the Republic of Cyprus, on an organised or permanent basis, the activities referred to under Article 3 of the abovementioned Law, unless represented by a resident company. The provision of tourist guide services and travel agencies and tour operators services requires nationality of a Member State (CPC 7471, 7472). Measures: CY: The Tourism and Travel Offices and Tourist Guides Law 1995 (Law 41(I)/1995) as amended). With respect to Investment liberalisation – Market access, National treatment, Most-favoured nation treatment and Cross-border trade in services – Market access, National treatment, Most-favoured nation treatment: In EL: Third-country nationals have to obtain a diploma from the Tourist Guide Schools of the Greek Ministry of Tourism, in order to be entitled to the right of practicing the profession. By exception, the right of practicing the profession can be temporarily (up to one year) accorded to third-country nationals under certain explicitly defined conditions, by way of derogation of the above mentioned provisions, in the event of the confirmed absence of a tourist guide for a specific language. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment,: In ES (for ES applies also to the regional level of government): Nationality of a Member State is required for the provision of tourist guide services (CPC 7472). In HR: EEA or Swiss nationality is required for hospitality and catering services in households and rural homesteads (CPC 641, 642, 643, 7471, 7472). Measures: EL: Presidential Degree 38/2010, Ministerial Decision 165261/IA/2010 (Gov. Gazette 2157/B), Article 50 of the law 4403/2016, Article 47 of the law 4582/2018 (Gov. Gazette 208/A). ES: Andalucía: Decreto 8/2015, de 20 de enero, Regulador de guías de turismo de Andalucía; Aragón: Decreto 21/2015, de 24 de febrero, Reglamento de Guías de turismo de Aragón; Cantabria: Decreto 51/2001, de 24 de julio, Article 4, por el que se modifica el Decreto 32/1997, de 25 de abril, por el que se aprueba el reglamento para el ejercicio de actividades turísticoinformativas privadas; Castilla y León: Decreto 25/2000, de 10 de febrero, por el que se modifica el Decreto 101/1995, de 25 de mayo, por el que se regula la profesión de guía de turismo de la Comunidad Autónoma de Castilla y León; Castilla la Mancha: Decreto 86/2006, de 17 de julio, de Ordenación de las Profesiones Turísticas; Cataluña: Decreto Legislativo 3/2010, de 5 de octubre, para la adecuación de normas con rango de ley a la Directiva 2006/123/CE, del Parlamento y del Consejo, de 12 de diciembre de 2006, relativa a los servicios en el mercado interior, Article 88; Comunidad de Madrid: Decreto 84/2006, de 26 de octubre del Consejo de Gobierno, por el que se modifica el Decreto 47/1996, de 28 de marzo; Comunidad Valenciana: Decreto 90/2010, de 21 de mayo, del Consell, por el que se modifica el reglamento regulador de la profesión de guía de turismo en el ámbito territorial de la Comunitat Valenciana, aprobado por el Decreto 62/1996, de 25 de marzo, del Consell; Extremadura: Decreto 37/2015, de 17 de marzo; Galicia: Decreto 42/2001, de 1 de febrero, de Refundición en materia de agencias de viajes, guias de turismo y turismo activo; Illes Balears: Decreto 136/2000, de 22 de septiembre, por el cual se modifica el Decreto 112/1996, de 21 de junio, por el que se regula la habilitación de guía turístico en las Islas Baleares; Islas Canarias: Decreto 13/2010, de 11 de febrero, por el que se regula el acceso y ejercicio de la profesión de guía de turismo en la Comunidad Autónoma de Canarias, Article 5; La Rioja: Decreto 14/2001, de 4 de marzo, Reglamento de desarrollo de la Ley de Turismo de La Rioja; Navarra: Decreto Foral 288/2004, de 23 de agosto. Reglamento para actividad de empresas de turismo activo y cultural de Navarra. Principado de Asturias: Decreto 59/2007, de 24 de mayo, por el que se aprueba el Reglamento regulador de la profesión de Guía de Turismo en el Principado de Asturias; and Región de Murcia: Decreto n.o 37/2011, de 8 de abril, por el que se modifican diversos decretos en materia de turismo para su adaptación a la ley 11/1997, de 12 de diciembre, de turismo de la Región de Murcia tras su modificación por la ley 12/2009, de 11 de diciembre, por la que se modifican diversas leyes para su adaptación a la directiva 2006/123/CE, del Parlamento Europeo y del Consejo de 12 de diciembre de 2006, relativa a los servicios en el mercado interior. HR: Hospitality and Catering Industry Act (OG 85/15, 121/16, 99/18, 25/19, 98/19, 32/20 and 42/20); and Act on Provision of Tourism Services (OG No. 130/17, 25/19, 98/19 and 42/20). With respect to Investment liberalisation – National treatment and Cross-border trade in services – Market access, National treatment: In HU: The supply of travel agent and tour operator services, and tourist guide services on a cross-border basis is subject to a licence issued by the Hungarian Trade Licensing Office. Licences are reserved to EEA nationals and legal persons having their seats in the EEA (CPC 7471, 7472). In IT (applies also to the regional level of government): tourist guides from non-European Union countries need to obtain a specific licence from the region in order to act as a professional tourist guide. Tourist guides from Member States can work freely without the requirement for such a licence. The licence is granted to tourist guides demonstrating adequate competence and knowledge (CPC 7472). Measures: HU: Act CLXIV of 2005 on Trade, Government Decree No. 213/1996 (XII.23.) on Travel Organisation and Agency Activities. IT: Law 135/2001 Articles 7.5 and 6; and Law 40/2007 (DL 7/2007). Reservation No. 15 - Recreational, cultural and sporting services Sector – sub-sector: Recreational services; other sporting services Industry classification: CPC 962, part of 96419 Type of reservation: Market access National treatment Senior management and boards of directors Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: Other sporting services (CPC 96419) With respect to Investment liberalisation – National treatment, Senior management and boards of directors and Cross-border trade in services –National treatment: In AT (applies to the regional level of government): The operation of ski schools and mountain guide services is governed by the laws of the Bundesländer. The provision of these services may require nationality of a Member State of the EEA. Enterprises may be required to appoint a managing director who is a national of a Member State of the EEA. With respect to Investment liberalisation – National treatment and Cross-border trade in services –National treatment: In CY: Nationality requirement for the establishment of a dance school and nationality requirement for physical instructors. Measures: AT: Kärntner Schischulgesetz, LGBL. Nr. 53/97; Kärntner Berg- und Schiführergesetz, LGBL. Nr. 25/98; NÖ- Sportgesetz, LGBL. Nr. 5710; OÖ- Sportgesetz, LGBl. Nr. 93/1997; Salzburger Schischul- und Snowboardschulgesetz, LGBL. Nr. 83/89; Salzburger Bergführergesetz, LGBL. Nr. 76/81; Steiermärkisches Schischulgesetz, LGBL. Nr.58/97; Steiermärkisches Berg- und Schiführergesetz, LGBL. Nr. 53/76; Tiroler Schischulgesetz. LGBL. Nr. 15/95; Tiroler Bergsportführergesetz, LGBL. Nr. 7/98; Vorarlberger Schischulgesetz, LGBL. Nr. 55/02 §4 (2)a; Vorarlberger Bergführergesetz, LGBL. Nr. 54/02; and Wien: Gesetz über die Unterweisung in Wintersportarten, LGBL. Nr. 37/02. CY: Law 65(I)/1997 as amended; and Law 17(I) /1995 as amended. Reservation No. 16 - Transport services and services auxiliary to transport services Sector – sub-sector: Transport services - fishing and water transportation – any other commercial activity undertaken from a ship; water transportation and auxiliary services for water transport; rail transport and auxiliary services to rail transport; road transport and services auxiliary to road transport; services auxiliary to air transport services Industry classification: ISIC Rev. 3.1 0501, 0502; CPC 5133, 5223, 711, 712, 721, 741, 742, 743, 744, 745, 748, 749, 7461, 7469, 83103, 86751, 86754, 8730, 882 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: (a) Maritime transport and auxiliary services for maritime transport. Any commercial activity undertaken from a ship (ISIC Rev. 3.1 0501, 0502; CPC 5133, 5223, 721, Part of 742, 745, 74540, 74520, 74590, 882) With respect to Investment liberalisation – Market access, and Cross-border trade in services – Market access: In EU: For port services, the managing body of a port, or the competent authority, may limit the number of providers of port services for a given port service. Measures: EU: Article 6 of Regulation (EU) 2017/352 of the European Parliament and of the Council (10). With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors; Cross-border trade in services – Market access, National treatment: In BG: The carriage and any activities related to hydraulic-engineering and underwater technical works, prospecting and extraction of mineral and other inorganic resources, pilotage, bunkering, receipt of waste, water-and-oil mixtures and other such, performed by vessels in the internal waters, and the territorial sea of Bulgaria, may only be performed by vessels flying the Bulgarian flag or vessels flying the flag of another Member State. The number of the service suppliers at the ports may be limited depending on the objective capacity of the port, which is decided by an expert commission, set up by the Minister of Transport, Information Technology and Communications. Nationality requirement for supporting services. The master and the chief engineer of the vessel shall mandatorily be nationals of a Member State of the EEA, or of the Swiss Confederation. (ISIC Rev. 3.1 0501, 0502, CPC 5133, 5223, 721, 74520, 74540, 74590, 882). Measures: BG: Merchant Shipping Code; Law For the Sea Water, Inland Waterways and Ports of the Republic of Bulgaria; Ordinance for the condition and order for selection of Bulgarian carriers for carriage of passengers and cargoes under international treaties; and Ordinance 3 for servicing of unmanned vessels. With respect to Investment liberalisation – Market access and Cross-border trade in services – Market access: In BG: Regarding supporting services for public transport carried out in Bulgarian ports, in ports having national significance, the right to perform supporting activities is granted through a concession contract. In ports having regional significance, this right is granted by a contract with the owner of the port (CPC 74520, 74540, 74590). Measures: BG: Merchant Shipping Code; Law For the Sea Water, Inland Waterways and Ports of the Republic of Bulgaria. With respect to Cross-border trade in services – Local presence: In DK: Pilotage-providers may only conduct pilotage service in Denmark, if they are domiciled in the EEA and registered and approved by the Danish Authorities in accordance with the Danish Act on Pilotage (CPC 74520). Measures: DK: Danish Pilotage Act, §18. With respect to Investment liberalisation - Market access, National treatment, Most-favoured nation treatment and Cross-border trade in services - Market access, National treatment, Most-favoured-nation treatment: In DE (applies also to the regional level of government): A vessel that does not belong to a national of a Member State may only be used for activities other than transport and auxiliary services in the German federal waterways after specific authorisation. Waivers for non- European Union vessels may only be granted if no European Union vessels are available or if they are available under very unfavourable conditions, or on the basis of reciprocity. Waivers for vessels flying under the United Kingdom flag may be granted on the basis of reciprocity (§ 2 paragraph 3 KüSchVO). All activities falling within the scope of the pilot law are regulated and accreditation is restricted to nationals of the EEA or the Swiss Confederation. Provision and Operation of facilities for pilotage is restricted to public authorities or companies, which are designated by them. For rental or leasing of seagoing vessels with or without operators, and for rental or leasing without operator of non-seagoing vessels, the conclusion of contracts for freight transport by ships flying a foreign flag or the chartering of such vessels may be restricted, depending on the availability of ships flying under the German flag or the flag of another Member State. Transactions between residents and non-residents concerning: (i) rental of inland waterway transport vessels, which are not registered in the economic area; (ii) transport of freight with such inland waterway transport vessels; or (iii) towing services by such inland waterway transport vessels, within the economic area may be restricted (Water transport, Supporting services for water transport, Rental of ships, Leasing services of ships without operators (CPC 721, 745, 83103, 86751, 86754, 8730)). Measures: DE: Gesetz über das Flaggenrecht der Seeschiffe und die Flaggenführung der Binnenschiffe (Flaggenrechtsgesetz; Flag Protection Act); Verordnung über die Küstenschifffahrt (KüSchV); Gesetz über die Aufgaben des Bundes auf dem Gebiet der Binnenschiffahrt (Binnenschiffahrtsaufgabengesetz - BinSchAufgG); Verordnung über Befähigungszeugnisse in der Binnenschiffahrt (Binnenschifferpatentverordnung - BinSchPatentV); Gesetz über das Seelotswesen (Seelotsgesetz - SeeLG); Gesetz über die Aufgaben des Bundes auf dem Gebiet der Seeschiffahrt (Seeaufgabengesetz - SeeAufgG); and Verordnung zur Eigensicherung von Seeschiffen zur Abwehr äußerer Gefahren (See-Eigensicherungsverordnung - SeeEigensichV). With respect to Investment liberalisation - Market access, National treatment and Cross-border trade in services - Market access, National treatment: In FI: supporting services for maritime transport when provided in Finnish maritime waters are reserved to fleets operating under the national, Union or Norwegian flag (CPC 745). Measures: FI: Merilaki (Maritime Act) (674/1994); and Laki elinkeinon harjoittamisen oikeudesta (Act on the Right to Carry on a Trade) (122/1919), s. 4. With respect to Investment liberalisation - Market access: In EL: Public monopoly imposed in port areas for cargo handling services (CPC 741). In IT: An economic needs test is applied for maritime cargo-handling services. Main criteria: number of and impact on existing establishments, population density, geographic spread and creation of new employment (CPC 741). Measures: EL: Code of Public Maritime Law (Legislative Decree 187/1973). IT: Shipping Code; Law 84/1994; and Ministerial decree 585/1995. (b) Rail transport and auxiliary services to rail transport (CPC 711, 743) With respect to Investment liberalisation - Market access, National treatment, and Cross-border trade in services - Market access, National treatment: In BG: Only nationals of a Member State may provide rail transport or supporting services for rail transport in Bulgaria. A licence to carry out passenger or freight transportation by rail is issued by the Minister of Transport to railway operators registered as traders (CPC 711, 743). Measures: BG: Law for Railway Transport, Articles 37 and 48. With respect to Investment liberalisation - Market access: In LT: The exclusive rights for the provision of transit services are granted to railway undertakings which are owned, or whose stock is 100 per cent owned, by the state (CPC 711). Measures: LT: Railway transport Code of the Republic of Lithuania of 22 April 2004 No. IX-2152 as amended by 8 June 2006 No. X-653. (c) Road transport and services auxiliary to road transport (CPC 712, 7121, 7122, 71222, 7123) For road transport services not covered by Heading Three of Part Two of this Agreement and Annex 31 to this Agreement With respect to Investment liberalisation - Market access, National treatment, and Cross-border trade in services - Market access, National treatment: In AT (with respect also to Most-favoured-nation treatment): For passenger and freight transportation, exclusive rights or authorisations may only be granted to nationals of the Contracting Parties of the EEA and to legal persons of the Union having their headquarters in Austria. Licences are granted on non– discriminatory terms, under condition of reciprocity (CPC 712). Measures: AT: Güterbeförderungsgesetz (Goods Transportation Act), BGBl. Nr. 593/1995; § 5; Gelegenheitsverkehrsgesetz (Occasional Traffic Act), BGBl. Nr. 112/1996; § 6; and Kraftfahrliniengesetz (Law on Scheduled Transport), BGBl. I Nr. 203/1999 as amended, §§ 7 and 8. With respect to Investment liberalisation - National treatment, Most-favoured-nation treatment: In EL: For operators of road freight transport services. In order to engage in the occupation of road freight transport operator a Hellenic licence is needed. Licences are granted on non– discriminatory terms, under condition of reciprocity (CPC 7123). Measures: EL: Licensing of road freight transport operators: Greek law 3887/2010 (Government Gazette A' 174), as amended by Article 5 of law 4038/2012 (Government Gazette A' 14). With respect to Investment liberalisation - Market access: In IE: Economic needs test for intercity bussing services. Main criteria: number of and impact on existing establishments, population density, geographical spread, impact on traffic conditions and creation of new employment (CPC 7121, CPC 7122). In MT: Taxis - numerical restrictions on the number of licences apply. Karozzini (horse drawn carriages): Numerical Restrictions on the number of licences apply (CPC 712). In PT: Economic needs test for limousine services. Main criteria: number of and impact on existing establishments, population density, geographic spread, impact on traffic conditions and creation of new employment (CPC 71222). Measures: IE: Public Transport Regulation Act 2009. MT: Taxi Services Regulations (SL499.59). PT: Decree-Law 41/80, August 21. With respect to Investment liberalisation – Market access and Cross-border trade in services - Local presence: In CZ: Incorporation in the Czech Republic is required (no branches). Measures: CZ: Act no. 111/1994. Coll. on Road Transport. With respect to Investment liberalisation - Market access, National treatment and Cross-border trade in services - Market access, National treatment, Most-favoured-nation treatment: In SE: In order to engage in the occupation of road transport operator, a Swedish licence is needed. Criteria for receiving a taxi licence include that the company has appointed a natural person to act as the transport manager (a de facto residency requirement – see the Swedish reservation on types of establishment). Measures: SE: Yrkestrafiklag (2012:210) (Act on professional traffic); Yrkestrafikförordning (2012:237) (Government regulation on professional traffic); Taxitrafiklag (2012:211) (Act on Taxis); and Taxitrafikförordning (2012:238) (Government regulation on taxis). With respect to Cross-border trade in services – Local presence: In SK: A taxi service concession and a permit for the operation of taxi dispatching can be granted to a person who has a residence or place of establishment in the territory of the Slovak Republic or in another EEA Member State. Measures: Act 56/2012 Coll. on Road Transport (d) Services auxiliary to air transport services With respect to Investment liberalisation - Market access, National treatment and Cross-border trade in services – Market access, National treatment: In EU: For groundhandling services, establishment within the Union territory may be required. The level of openness of groundhandling services depends on the size of airport. The number of suppliers in each airport may be limited. For "big airports", this limit may not be less than two suppliers. Measures: EU: Council Directive 96/67/EC of 15 October 1996 (11). In BE (applies also to the regional level of government): For groundhandling services, reciprocity is required. Measures: BE: Arrêté Royal du 6 novembre 2010 réglementant l'accès au marché de l'assistance en escale à l'aéroport de Bruxelles-National (Article 18); Besluit van de Vlaamse Regering betreffende de toegang tot de grondafhandelingsmarkt op de Vlaamse regionale luchthavens (Article 14); and Arrêté du Gouvernement wallon réglementant l'accès au marché de l'assistance en escale aux aéroports relevant de la Région wallonne (Article14). (e) Supporting services for all modes of transport (part of CPC 748) With respect to Cross-border trade in services – Local presence: The EU (applies also to the regional level of government): Customs clearance services may only be provided by Union residents or legal persons established in the Union. Measures: EU: Regulation (EU) No 952/2013 of the European Parliament and of the Council (12) Reservation No. 17 - Energy related activities Sector – sub-sector: Energy related activities - mining and quarrying; production, transmission and distribution on own account of electricity, gas, steam and hot water; pipeline transportation of fuels; storage and warehouse of fuels transported through pipelines; and services incidental to energy distribution Industry classification: ISIC Rev. 3.1 10, 11, 12, 13, 14, 40, CPC 5115, 63297, 713, part of 742, 8675, 883, 887 Type of reservation: Market access National treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: (a) Mining and quarrying (ISIC Rev. 3.1 10, 11, 12, 13, 14, CPC 5115, 7131, 8675, 883) With respect to Investment liberalisation – Market access: In NL: The exploration for and exploitation of hydrocarbons in the Netherlands is always performed jointly by a private company and the public (limited) company designated by the Minister of Economic Affairs. Articles 81 and 82 of the Mining Act stipulate that all shares in this designated company must be directly or indirectly held by the Dutch State (ISIC Rev. 3.1 10, 3.1 11, 3.1 12, 3.1 13, 3.1 14). In BE: The exploration for and exploitation of mineral resources and other non-living resources in territorial waters and the continental shelf are subject to concession. The concessionaire must have an address for service in Belgium (ISIC Rev. 3.1:14). In IT (applies also to the regional level of government for exploration): Mines belonging to the State have specific exploration and mining rules. Prior to any exploitation activity, a permit for exploration is needed ("permesso di ricerca", Article 4 Royal Decree 1447/1927). This permit has a duration, defines exactly the borders of the ground under exploration and more than one exploration permit may be granted for the same area to different persons or companies (this type of licence is not necessarily exclusive). In order to cultivate and exploit minerals, an authorisation ("concessione", Article 14) from the regional authority is required (ISIC Rev. 3.1 10, 3.1 11, 3.1 12, 3.1 13, 3.1 14, CPC 8675, 883). Measures BE: Arrêté Royal du 1er septembre 2004 relatif aux conditions, à la délimitation géographique et à la procédure d'octroi des concessions d'exploration et d'exploitation des ressources minérales et autres ressources non vivantes de la mer territoriale et du plateau continental. IT: Exploration services: Royal Decree 1447/1927; and Legislative Decree 112/1998, Article 34. NL: Mijnbouwwet (Mining Act). With respect to Investment liberalisation – Market access, National treatment, Most-favoured nation treatment: In BG: The activities of prospecting or exploration of underground natural resources on the territory of the Republic of Bulgaria, in the continental shelf and in the exclusive economic zone in the Black Sea are subject to permission, while the activities of extraction and exploitation are subject to concession granted under the Underground Natural Resources Act. It is forbidden for companies registered in preferential tax treatment jurisdictions (that is, offshore zones) or related, directly or indirectly, to such companies to participate in open procedures for granting permits or concessions for prospecting, exploration or extraction of natural resources, including uranium and thorium ores, as well as to operate an existing permit or concession which has been granted, as such operations are precluded, including the possibility to register the geological or commercial discovery of a deposit as a result of exploration. The mining of uranium ore is closed by Decree of the Council of Ministers No. 163 of 20.08.1992. With regard to exploration and mining of thorium ore, the general regime of permits and concessions applies. Decisions to allow the exploration or mining of thorium ore are taken on a non-discriminatory individual case-by-case basis. According to Decision of the National Assembly of the Republic of Bulgaria of 18 Jan 2012 (ch. 14 June 2012) any usage of hydraulic fracturing technology that is, fracking, for activities of prospecting, exploration or extraction of oil and gas is forbidden. Exploration and extraction of shale gas is forbidden (ISIC Rev. 3.1 10, 3.1 11, 3.112, 3.1 13,3.1 14). Measures: BG: Underground Natural Resources Act; Concessions Act; Law on Privatisation and Post-Privatisation Control; Safe Use of Nuclear Energy Act; Decision of the National Assembly of the Republic of Bulgaria of 18 Jan 2012; Economic and Financial Relations with Companies Registered in Preferential Tax Treatment Jurisdictions, the Persons Controlled Thereby and Their Beneficial Owners Act; and Subsurface Resources Act. With respect to Investment liberalisation – Market access, National treatment, Most-favoured nation treatment: In CY: The Council of Ministers may refuse to allow the activities of prospecting, exploration and exploitation of hydrocarbons to be carried out by any entity which is effectively controlled by the United Kingdom or by nationals of the United Kingdom. After the granting of an authorisation, no entity may come under the direct or indirect control of the United Kingdom or a national of the United Kingdom without the prior approval of the Council of Ministers. The Council of Ministers may refuse to grant an authorisation to an entity which is effectively controlled by the United Kingdom or by a national of the United Kingdom, if the United Kingdom does not grant entities of the Republic or entities of Member States as regards access to and exercise of the activities of prospecting, exploring for and exploiting hydrocarbons, treatment comparable to that which the Republic or Member State grants entities from the United Kingdom (ISIC Rev 3.1 1110). Measures: CY: The Hydrocarbons (Prospecting, Exploration and Exploitation Law) of 2007, (Law 4(I)/2007) as amended. With respect to Investment liberalisation – Market access, National treatment and Cross-border services – Local presence: In SK: For mining, activities related to mining and geological activity, incorporation in the EEA is required (no branching). Mining and prospecting activities covered by Act of the Slovak Republic 44/1988 on protection and exploitation of natural resources are regulated on a non-discriminatory basis, including through public policy measures seeking to ensure the conservation and protection of natural resources and the environment such as the authorisation or prohibition of certain mining technologies. For greater certainty, such measures include the prohibition of the use of cyanide leaching in the treatment or refining of minerals, the requirement of a specific authorisation in the case of fracking for activities of prospecting, exploration or extraction of oil and gas, as well as prior approval by local referendum in the case of nuclear/radioactive mineral resources. This does not increase the non-conforming aspects of the existing measure for which the reservation is taken. (ISIC Rev. 3.1 10, 3.1 11, 3.1 12, 3.1 13, 3.1 14, CPC 5115, 7131, 8675 and 883). Measures SK: Act 51/1988 on Mining, Explosives and State Mining Administration; and Act 569/2007 on Geological Activity, Act 44/1988 on protection and exploitation of natural resources. With respect to Investment liberalisation – Market access and Cross-border trade in services – Local presence: In FI: The exploration for and exploitation of mineral resources are subject to a licensing requirement, which is granted by the Government in relation to the mining of nuclear material. A permit of redemption for a mining area is required from the Government. Permission may be granted to a natural person resident in the EEA or a legal person established in the EEA. An economic needs test may apply (ISIC Rev. 3.1 120, CPC 5115, 883, 8675). In IE: Exploration and mining companies operating in Ireland are required to have a presence there. In the case of minerals exploration, there is a requirement that companies (Irish and foreign) employ either the services of an agent or a resident exploration manager in Ireland while work is being undertaken. In the case of mining, it is a requirement that a State Mining Lease or License be held by a company incorporated in Ireland. There are no restrictions as to ownership of such a company (ISIC Rev. 3.1 10, 3.1 13, 3.1 14, CPC 883). Measures FI: Kaivoslaki (Mining Act) (621/2011); and Ydinenergialaki (Nuclear Energy Act) (990/1987). IE: Minerals Development Acts 1940 – 2017; and Planning Acts and Environmental Regulations. With respect only to Investment – Market access, National treatment and Cross-border trade in services – Local presence: In SI: The exploration for and exploitation of mineral resources, including regulated mining services, are subject to establishment in or citizenship of the EEA, the Swiss Confederation or an OECD Member(ISIC Rev. 3.1 10, ISIC Rev. 3.1 11, ISIC Rev. 3.1 12, ISIC Rev. 3.1 13, ISIC Rev. 3.1 14, CPC 883, CPC 8675). Measures SI: Mining Act 2014. (b) Production, transmission and distribution on own account of electricity, gas, steam and hot water; pipeline transportation of fuels; storage and warehouse of fuels transported through pipelines; services incidental to energy distribution (ISIC Rev. 3.1 40, 3.1 401, CPC 63297, 713, part of 742, 74220, 887) With respect to Investment liberalisation – Market access: In DK: The owner or user intending to establish gas infrastructure or a pipeline for the transport of crude or refined petroleum and petroleum products and of natural gas must obtain a permit from the local authority before commencing work. The number of such permits which are issued may be limited (CPC 7131). In MT: EneMalta plc has a monopoly for the provision of electricity (ISIC Rev. 3.1 401; CPC 887). In NL: the ownership of the electricity network and the gas pipeline network are exclusively granted to the Dutch government (transmission systems) and other public authorities (distribution systems) (ISIC Rev. 3.1 040, CPC 71310). Measures: DK: Lov om naturgasforsyning, LBK 1127 05/09/2018, lov om varmeforsyning, LBK 64 21/01/2019, lov om Energinet, LBK 997 27/06/2018. Bekendtgørelse nr. 1257 af 27. november 2019 om indretning, etablering og drift af olietanke, rørsystemer og pipelines (Order no. 1257 of November 27th, 2019, on the arrangement, establishment and operation of oil tanks, piping systems and pipelines). MT: EneMalta Act Cap. 272 and EneMalta (Transfer of Assets, Rights, Liabilities & Obligations) Act Cap. 536. NL: Elektriciteitswet 1998; Gaswet. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – National treatment, Local presence: In AT: With regard to the transportation of gas authorisation is only granted to nationals of a Member State of the EEA domiciled in the EEA. Enterprises and partnerships must have their seat in the EEA. The operator of the network must appoint a Managing Director and a Technical Director who is responsible for the technical control of the operation of the network, both of whom must be nationals of a member state of the EEA. The competent authority may waive the nationality and domiciliation requirements where the operation of the network is considered to be in the public interest. For the transportation of goods other than gas and water, the following applies: (i) with regard to natural persons, authorisation is only granted to EEA-nationals who must have a seat in Austria; and (ii) enterprises and partnerships must have their seat in Austria. An Economic Needs Test or interest test is applied. Cross border pipelines must not jeopardise Austria's security interests and its status as a neutral country. Enterprises and partnerships have to appoint a managing director who must be a national of a member state of the EEA. The competent authority may waive the nationality and seat requirements if the operation of the pipeline is considered to be in the national economic interest (CPC 713). Measures: AT: Rohrleitungsgesetz (Law on Pipeline Transport), BGBl. Nr. 411/1975, § 5(1) and (2), §§ 5 (1) and (3), 15, 16; and Gaswirtschaftsgesetz 2011(Gas Act), BGBl. I Nr. 107/2011, Articles 43 and 44, Articles 90 and 93. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of director and Cross-border trade in services – (applies only to the regional level of government) National treatment, Local presence: In AT: With regard to transmission and distribution of electricity, authorisation is only granted to nationals of a Member State of the EEA domiciled in the EEA. If the operator appoints a managing director or a leaseholder, the domicile requirement is waived. Legal persons (enterprises) and partnerships must have their seat in the EEA. They must appoint a managing director or a leaseholder, both of whom must be nationals of a Member State of the EEA domiciled in the EEA. The competent authority may waive the domicile and nationality requirements where the operation of the network is considered to be in the public interest (ISIC Rev. 3.1 40, CPC 887). Measures: AT: Burgenländisches Elektrizitätswesengesetz 2006, LGBl. Nr. 59/2006 as amended; Niederösterreichisches Elektrizitätswesengesetz, LGBl. Nr. 7800/2005 as amended; Landesgesetz, mit dem das Oberösterreichische Elektrizitätswirtschafts- und -organisationsgesetz 2006 erlassen wird (Oö. ElWOG 2006), LGBl. Nr. 1/2006 as amended; Salzburger Landeselektrizitätsgesetz 1999 (LEG), LGBl. Nr. 75/1999 as amended; Gesetz vom 16. November 2011 über die Regelung des Elektrizitätswesens in Tirol (Tiroler Elektrizitätsgesetz 2012 – TEG 2012), LGBl. Nr. 134/2011; Gesetz über die Erzeugung, Übertragung und Verteilung von elektrischer Energie (Vorarlberger Elektrizitätswirtschaftsgesetz), LGBl. Nr. 59/2003 as amended; Gesetz über die Neuregelung der Elektrizitätswirtschaft (Wiener Elektrizitätswirtschaftsgesetz 2005 – WElWG 2005), LGBl. Nr. 46/2005; Steiermärkisches Elektrizitätswirtschafts- und Organisationsgesetz(ELWOG), LGBl. Nr. 70/2005; and Kärntner Elektrizitätswirtschafts-und Organisationsgesetz(ELWOG), LGBl. Nr. 24/2006. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Local presence: In CZ: For electricity generation, transmission, distribution, trading, and other electricity market operator activities, as well as gas generation, transmission, distribution, storage and trading, as well as heat generation and distribution, authorisation is required. Such authorisation may only be granted to a natural person with a residence permit or a legal person established in the Union. Exclusive rights exist with regard to electricity and gas transmission and market operator licences (ISIC Rev. 3.1 40, CPC 7131, 63297, 742, 887). In LT: The licences for transmission, distribution, public supply and organizing of trade of electricity may only be issued to legal persons established in the Republic of Lithuania or branches of foreign legal persons or other organisations of another Member State established in the Republic Lithuania. The permits to generate electricity, develop electricity generation capacities and build a direct line may be issued to individuals with residency in the Republic of Lithuania or to legal persons established in the Republic of Lithuania, or to branches of legal persons or other organizations of another Member States established in the Republic of Lithuania. This reservation does not apply to consultancy services related to the transmission and distribution on a fee or contract basis of electricity (ISIC Rev. 3.1 401, CPC 887). In the case of fuels, establishment is required. Licences for transmission and distribution, storage of fuels and liquefaction of natural gas may only be issued to legal persons established in the Republic of Lithuania or branches of legal persons or other organisations (subsidiaries) of another Member State established in the Republic Lithuania. This reservation does not apply to consultancy services related to the transmission and distribution on a fee or contract basis of fuels (CPC 713, CPC 887). In PL: the following activities are subject to licensing under the Energy Law Act: (i) generation of fuels or energy, except for: generation of solid or gaseous fuels; generation of electricity using electricity sources of the total capacity of not more than 50 MW other than renewable energy sources; cogeneration of electricity and heat using sources of the total capacity of not more than 5 MW other than renewable energy sources; generation of heat using the sources of the total capacity of not more than 5 MW; (ii) storage of gaseous fuels in storage installations, liquefaction of natural gas and regasification of liquefied natural gas at LNG installations, as well as the storage of liquid fuels, except for: the local storage of liquid gas at installations of the capacity of less than 1 MJ/s capacity and the storage of liquid fuels in retail trade; (iii) transmission or distribution of fuels or energy, except for: the distribution of gaseous fuels in grids of less than 1 MJ/s capacity and the transmission or distribution of heat if the total capacity ordered by customers does not exceed 5 MW; (iv) trade in fuels or energy, except for: the trade in solid fuels; the trade in electricity using installations of voltage lower than 1 kV owned by the customer; the trade in gaseous fuels if their annual turnover value does not exceed the equivalent of EUR 100 000; the trade in liquid gas, if the annual turnover value does not exceed EUR 10 000; and the trade in gaseous fuels and electricity performed on commodity exchanges by brokerage houses which conduct the brokerage activity on the exchange commodities on the basis of the Act of 26 October 2000 on commodity exchanges, as well as the trade in heat if the capacity ordered by the customers does not exceed 5 MW. The limits on turnover do not apply to wholesale trade services in gaseous fuels or liquid gas or to retail services of bottled gas. A licence may only be granted by the competent authority to an applicant that has registered their principal place of business or residence in the territory of a Member State of the EEA or the Swiss Confederation (ISIC Rev. 3.1 040, CPC 63297, 74220, CPC 887). Measures: CZ: Act No. 458/2000 Coll on Business conditions and public administration in the energy sectors (The Energy Act). LT: Law on Natural Gas of the Republic of Lithuania of 10 October 2000 No VIII-1973; and Law on electricity of the Republic of Lithuania of 20 July 2000 No VIII-1881. PL: Energy Law Act of 10 April 1997, Articles 32 and 33. With respect to Cross-border trade in services – Local presence: In SI: The production, trading, supply to final customers, transmission and distribution of electricity and natural gas is subject to establishment in the Union (ISIC Rev. 3.1 4010, 4020, CPC 7131, CPC 887). Measures: SI: Energetski zakon (Energy Act) 2014, Official Gazette RS, nr. 17/2014; and Mining Act 2014. Reservation No. 18 - Agriculture, fishing and manufacturing Sector – sub-sector: Agriculture, hunting, forestry; animal and reindeer husbandry, fishing and aquaculture; publishing, printing and reproduction of recorded media Industry classification: ISIC Rev. 3.1 011, 012, 013, 014, 015, 1531, 050, 0501, 0502, 221, 222, 323, 324, CPC 881, 882, 88442 Type of reservation: Market access National treatment Most-favoured-nation treatment Performance requirements Senior management and boards of directors Local presence Chapter: Investment liberalisation; Cross-border trade in services Level of government: EU/Member State (unless otherwise specified) Description: (a) Agriculture, hunting and forestry (ISIC Rev. 3.1 011, 012, 013, 014, 015, 1531, CPC 881) With respect to Investment liberalisation – National treatment: In IE: Establishment by foreign residents in flour milling activities is subject to authorisation (ISIC Rev. 3.1 1531). Measures: IE: Agriculture Produce (Cereals) Act, 1933. With respect to Investment liberalisation – Market access, National treatment: In FI: Only nationals of a Member State of the EEA resident in the reindeer herding area may own reindeer and practice reindeer husbandry. Exclusive rights may be granted. In FR: Prior authorisation is required in order to become a member or act as a director of an agricultural cooperative (ISIC Rev. 3.1 011, 012, 013, 014, 015). In SE: Only Sami people may own and practice reindeer husbandry. Measures: FI: Poronhoitolaki (Reindeer Husbandry Act) (848/1990), Chapter 1, s. 4, Protocol 3 to the Accession Treaty of Finland. FR: Code rural et de la pêche maritime. SE: Reindeer Husbandry Act (1971:437), section 1. (b) Fishing and aquaculture (ISIC Rev. 3.1 050, 0501, 0502, CPC 882) With respect to Investment liberalisation – Market access, National treatment and Cross-border services: Market access: In FR: A French vessel flying the French flag may be issued a fishing authorisation or may be allowed to fish on the basis of national quotas only when a real economic link on the territory of France is established and the vessel is directed and controlled from a permanent establishment located on the territory of France (ISIC Rev. 3.1 050, CPC 882). Measures: FR: Code rural et de la pêche maritime. (c) Manufacturing - Publishing, printing and reproduction of recorded media (ISIC Rev. 3.1 221, 222, 323, 324, CPC 88442) With respect to Investment liberalisation – Market access, National treatment and Cross-border services: Market access, National treatment, Local presence: In LV: Only legal persons incorporated in Latvia, and natural persons of Latvia have the right to found and publish mass media. Branches are not allowed (CPC 88442). Measures: LV: Law on the Press and Other Mass Media, s. 8. With respect to Investment liberalisation – National treatment and Cross-border trade in services – Local presence: In DE (applies also to the regional level of government): Each publicly distributed or printed newspaper, journal, or periodical must clearly indicate a "responsible editor" (the full name and address of a natural person). The responsible editor may be required to be a permanent resident of Germany, the Union or an EEA Member State. Exceptions may be allowed by the Federal Minister of the Interior (ISIC Rev. 3.1 223, 224). Measures: DE: Regional level: Gesetz über die Presse Baden-Württemberg (LPG BW); Bayerisches Pressegesetz (BayPrG); Berliner Pressegesetz (BlnPrG); Brandenburgisches Landespressegesetz (BbgPG); Gesetz über die Presse Bremen (BrPrG); Hamburgisches Pressegesetz; Hessisches Pressegesetz (HPresseG); Landespressegesetz für das Land Mecklenburg-Vorpommern (LPrG M-V); Niedersächsisches Pressegesetz (NPresseG); Pressegesetz für das Land Nordrhein-Westfalen (Landespressegesetz NRW); Landesmediengesetz (LMG) Rheinland-Pfalz; Saarländisches Mediengesetz (SMG); Sächsisches Gesetz über die Presse (SächsPresseG); Pressegesetz für das Land Sachsen-Anhalt (Landespressegesetz); Gesetz über die Presse Schleswig-Holstein (PressG SH); Thüringer Pressegesetz (TPG). With respect to Investment liberalisation – Market Access, National Treatment: In IT: In so far as the United Kingdom allow Italian investors to own more than 49 per cent of the capital and voting rights in a publishing company of the United Kingdom, then Italy will allow investors of the United Kingdom to own more than 49 per cent of the capital and voting rights in an Italian publishing company under the same conditions (ISIC Rev. 3.1 221, 222). Measures: IT: Law 416/1981, Article 1 (and subsequent amendments). With respect to Investment liberalisation – Senior management and boards of directors: In PL: Nationality is required for the editor-in-chief of newspapers and journals (ISIC Rev. 3.1 221, 222). Measures: PL: Act of 26 January 1984 on Press law, Journal of Laws, No. 5, item 24, with subsequent amendments. With respect to Investment liberalisation – National treatment and Cross-border trade in services –National treatment, Local presence: In SE: Natural persons who are owners of periodicals that are printed and published in Sweden must reside in Sweden or be nationals of a Member State of the EEA. Owners of such periodicals who are legal persons must be established in the EEA. Periodicals that are printed and published in Sweden and technical recordings must have a responsible editor, who must be domiciled in Sweden (ISIC Rev. 3.1 22, CPC 88442). Measures: SE: Freedom of the press act (1949:105); Fundamental law on Freedom of Expression (1991:1469); and Act on ordinances for the Freedom of the Press Act and the Fundamental law on Freedom of Expression (1991:1559). Schedule of the United Kingdom Reservation No. 1 – All sectors Reservation No. 2 – Professional services (all professions except health-related) Reservation No. 3 – Professional services (veterinary services) Reservation No. 4 – Research and development services Reservation No. 5 – Business services Reservation No. 6 – Communication services Reservation No. 7 – Transport services and services auxiliary to transport services Reservation No. 8 – Energy related activities Reservation No. 1 – All sectors Sector All sectors Type of reservation: Market access National treatment Most favoured nation treatment Senior management and boards of directors Performance requirements Chapter: Investment liberalisation Level of government: Central and Regional (unless otherwise specified) Description: With respect to Investment liberalisation – Performance requirements The United Kingdom may enforce a commitment or undertaking given in accordance with the provisions governing post-offer undertakings in the City Code on Takeovers and Mergers, or pursuant to Deeds of Undertaking in relation to takeovers or mergers, where the commitment or undertaking is not imposed or required as a condition of approval of the takeover or merger. Measures: The City Code on Takeovers and Mergers Companies Act 2006 Law of Property (Miscellaneous Provisions) Act 1989 as regards enforcement of Deeds of Undertaking in relation to takeovers or mergers With respect to Investment liberalisation – Market access, National treatment and Senior management and boards of directors This reservation applies only to health, social or education services: The UK, when selling or disposing of its equity interests in, or the assets of, an existing state enterprise or an existing governmental entity providing health, social or education services (CPC 93, 92), may prohibit or impose limitations on the ownership of such interests or assets, and on the ability of owners of such interests and assets to control any resulting enterprise, by investors of the Union or their enterprises. With respect to such a sale or other disposition, the UK may adopt or maintain any measure relating to the nationality of senior management or members of the boards of directors, as well as any measure limiting the number of suppliers. For the purposes of this reservation: (i) any measure maintained or adopted after entry into force of this Agreement that, at the time of the sale or other disposition, prohibits or imposes limitations on the ownership of equity interests or assets or imposes nationality requirements or imposes limitations on the numbers of suppliers as described in this reservation shall be deemed to be an existing measure; and (ii) "state enterprise" means an enterprise owned or controlled through ownership interests by the UK and includes an enterprise established after entry into force of this Agreement solely for the purposes of selling or disposing of equity interests in, or the assets of, an existing state enterprise or governmental entity. Measures: As set out in the Description element as indicated above. Reservation No. 2 – Professional services (all professions except health-related) Sector – sub-sector: Professional services – legal services; auditing services Industry classification: Part of CPC 861, CPC 862 Type of reservation: Market access National treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: (a) Legal services (part of CPC 861) In order to provide certain legal services, it may be necessary to obtain authorisation or a licence from a competent authority, or to comply with registration requirements. To the extent that the requirements for obtaining authorisation or a licence, or registration, are non-discriminatory and conform with commitments imposed by Article 194 of this Agreement, they are not listed. These may, for example, include a requirement to having obtained specified qualifications, having completed a recognised period of training, or requiring upon membership an office or a post address within the competent authority's jurisdiction. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, Local presence, National treatment: Residency (commercial presence) may be required by the relevant professional or regulatory body for the provision of some UK domestic legal services. Non-discriminatory legal form requirements apply. Residency may be required by the relevant professional or regulatory body for the provision of certain UK domestic legal services in relation to immigration. Measures: For England and Wales, the Solicitors Act 1974, the Administration of Justice Act 1985 and the Legal Services Act 2007. For Scotland, the Solicitors (Scotland) Act 1980 and the Legal Services (Scotland) Act 2010. For Northern Ireland, the Solicitors (Northern Ireland) Order 1976. For all jurisdictions, the Immigration and Asylum Act 1999. In addition, the measures applicable in each jurisdiction include any requirements set by professional and regulatory bodies. (b) Auditing services (CPC 86211, 86212 other than accounting and bookkeeping services) With respect to Investment liberalisation – National treatment and cross-border trade in Services – National treatment: The competent authorities of the UK may recognise the equivalence of the qualifications of an auditor who is a national of the Union or of any third country in order to approve them to act as a statutory auditor in the UK subject to reciprocity (CPC 8621). Measures: The Companies Act 2006 Reservation No. 3 – Professional services (veterinary services) Sector – sub-sector: Professional services – veterinary services Industry classification: CPC 932 Type of reservation: Market access Local presence Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: Physical presence is required to perform veterinary surgery. The practice of veterinary surgery is reserved to qualified veterinary surgeons who are registered with the Royal College of Veterinary Surgeons (RCVS). Measures: Veterinary Surgeons Act 1966 Reservation No. 4 – Research and development services Sector – sub-sector: Research and development (R&D) services Industry classification: CPC 851, 853 Type of reservation: Market access National treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: For publicly funded research and development (R&D) services benefitting from funding provided by the UK, exclusive rights or authorisations may only be granted to nationals of the UK and to legal persons of the UK having their registered office, central administration or principal place of business in the UK (CPC 851, 853). This reservation is without prejudice to Part Five of this Agreement and to the exclusion of procurement by a Party or subsidies or grants provided by the Parties in Article 123(6) and (7) of this Agreement. Measures: All currently existing and all future research or innovation programmes. Reservation No. 5 – Business services Sector – sub-sector: Business services – rental or leasing services without operators and other business services Industry classification: Part of CPC 831 Type of reservation: Market access National treatment Most-favoured-nation treatment Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: For rental or leasing of aircraft without crew (dry lease) aircraft used by an air carrier of the UK are subject to applicable aircraft registration requirements. A dry lease agreement to which a UK carrier is a party shall be subject to requirements in the national law on aviation safety, such as prior approval and other conditions applicable to the use of third countries' registered aircraft. To be registered, aircraft may be required to be owned either by natural persons meeting specific nationality criteria or by enterprises meeting specific criteria regarding ownership of capital and control (CPC 83104). With respect to computer reservation system (CRS) services, where the UK air carriers are not accorded, by CRS services suppliers operating outside the UK, equivalent (meaning non-discriminatory) treatment to that provided in the UK, or where UK CRS services suppliers are not accorded, by non-UK air carriers, equivalent treatment to that provided in the UK, measures may be taken to accord equivalent discriminatory treatment, respectively, to the non-UK air carriers by the CRS services suppliers operating in the UK, or to the non-UK CRS services suppliers by UK air carriers. Measures: Regulation (EC) No 1008/2008 of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the Community (Recast) as retained in UK law by the European Union (Withdrawal) Act 2018 and as amended by the Operation of Air Services (Amendment etc.) (EU Exit) Regulations (S.I. 2018/1392). Regulation (EC) No 80/2009 of the European Parliament and of the Council of 14 January 2009 on a Code of Conduct for computerised reservation systems and repealing Council Regulation (EEC) No 2299/89, as retained in UK law by the European Union (Withdrawal) Act 2018 and as amended by the Computer Reservation Systems (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1080). Reservation No. 6 – Communication services Sector – sub-sector: Communication services - postal and courier services Industry classification: Part of CPC 71235, part of 73210, part of 751 Type of reservation: Market access Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: The organisation of the siting of letter boxes on the public highway, the issuing of postage stamps and the provision of the registered mail service used in the course of judicial or administrative procedures may be restricted in accordance with national legislation. For greater certainty, postal operators may be subject to particular universal service obligations or a financial contribution to a compensation fund. Measures: Postal Services Act 2000 and Postal Services Act 2011 Reservation No. 7 – Transport services and services auxiliary to transport services Sector – sub-sector: Transport services - auxiliary services for water transport, auxiliary services to rail transport, services auxiliary to road transport, services auxiliary to air transport services Industry classification: CPC 711, 712, 721, 741, 742, 743, 744, 745, 746, 748, 749 Type of reservation: Market access National treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: (a) Services auxiliary to air transport services (CPC 746) With respect to Investment liberalisation - Market access and Cross-border trade in services - Market access: The level of openness of groundhandling services depends on the size of airport. The number of suppliers in each airport may be limited. For "big airports", this limit may not be less than two suppliers. Measures: The Airports (Groundhandling) Regulations 1997 (S.I. 1997/2389) (b) Supporting services for all modes of transport With respect to Investment liberalisation - National treatment and Cross-border trade in services - Market access, Local presence, National treatment: Customs services, including customs clearance services and services relating to use of temporary storage facilities or customs warehouses, may only be provided by persons established in the UK. For the avoidance of doubt, this includes UK residents, persons with a permanent place of business in the UK or a registered office in the UK. Measures: Taxation (Cross-Border Trade Act) 2018; the Customs and Excise Management Act 1979; the Customs (Export) (EU Exit) Regulations 2019; the Customs (Import Duty) (EU Exit) Regulations 2018; the Customs (Special Procedures and Outward Processing) (EU Exit) Regulations 2018; the Customs and Excise (Miscellaneous Provisions and Amendments) (EU Exit) Regulations 2019/1215. (c) Auxiliary services for water transport With respect to Investment liberalisation – Market access, and Cross-border trade in Services – Market access: For port services, the managing body of a port, or the competent authority, may limit the number of providers of port services for a given port service. Measures: Regulation (EU) 2017/352 of 15 February 2017 establishing a framework for the provision of port services and common rules on the financial transparency of ports, Article 6 as retained in UK law by the European Union (Withdrawal) Act 2018 and as amended by the Pilotage and Port Services (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/671) Port Services Regulations 2019 Reservation No. 8 – Energy related activities Sector – sub-sector: Energy related activities - mining and quarrying Industry classification: ISIC Rev. 3.1 11, 8675, 883 Type of reservation: Market access Chapter: Investment liberalisation and Cross-border trade in services Level of government: Central and Regional (unless otherwise specified) Description: A licence is necessary to undertake exploration and production activities on the UK Continental Shelf (UKCS), and to provide services which require direct access to or exploitation of natural resources. This reservation applies to production licences issued with respect to the UK Continental Shelf. To be a Licensee, a company must have a place of business within the UK. That means either: (i) a staffed presence in the UK; (ii) registration of a UK company at Companies House; or (iii) registration of a UK branch of a foreign company at Companies House. This requirement exists for any company applying for a new licence and for any company seeking to join an existing licence by assignment. It applies to all licences and to all enterprises, whether operator or not. To be a party to a licence that covers a producing field, a company must: (a) be registered at Companies House as a UK company; or (b) carry on its business through a fixed place of business in the UK as defined in section 148 of the Finance Act 2003 (which normally requires a staffed presence) (ISIC Rev. 3.1 11, CPC 883, 8675). Measures: Petroleum Act 1998 (1) For the purposes of this reservation: (a) "host-jurisdiction law" means the law of the specific Member State and Union law; "home-jurisdiction law" means the law of the United Kingdom; (b) "international law" means public international law with the exception of European Union law, and includes law established by international treaties and conventions, as well as international customary law; (c) "legal advisory services" includes provision of advice to and consultation with clients in matters, including transactions, relationships and disputes, involving the application or interpretation of law; participation with or on behalf of clients in negotiations and other dealings with third parties in such matters; and preparation of documents governed in whole or in part by law, and the verification of documents of any kind for purposes of and in accordance with the requirements of law; (d) "legal representational services" includes preparation of documents intended to be submitted to administrative agencies, the courts or other duly constituted official tribunals; and appearance before administrative agencies, the courts or other duly constituted official tribunals; (e) "legal arbitration, conciliation and mediation services" means the preparation of documents to be submitted to, the preparation for and appearance before, an arbitrator, conciliator or mediator in any dispute involving the application and interpretation of law. It does not include arbitration, conciliation and mediation services in disputes not involving the application and interpretation of law, which fall under services incidental to management consulting. It also does not include acting as an arbitrator, conciliator or mediator. As a sub-category, international legal arbitration, conciliation or mediation services refers to the same services when the dispute involves parties from two or more countries. (2) Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ EU L 154, 16.6.2017, p. 1). (3) Council Regulation (EC) No 6/2002 of 12 December 2001 on Community designs (OJ EU L 3, 5.1.2002, p. 1). (4) Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ EU L 182, 29.6.2013, p. 19). (5) Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directives 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ EU L 157, 9.6.2006, p. 87). (6) Regulation (EC) No 1008/2008 of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the Community (OJ EU L 293 31.10.2008, p. 3). (7) Regulation (EC) No 80/2009 of the European Parliament and of the Council of 14 January 2009 on a Code of Conduct for computerised reservation systems and repealing Council Regulation (EEC) No 2299/89 (OJ EU L 35, 4.2.2009, p. 47). (8) Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service (OJ EU L 15 21.1.1998, p. 14). (9) Regulation (EU) No 909/2014 of the European Parliament and of the Council of 23 July 2014 on improving securities settlement in the European Union and on central securities depositories and amending Directives 98/26/EC and 2014/65/EU and Regulation (EU) No 236/2012 (OJ EU L 257 28.8.2014, p. 1). (10) Regulation (EU) 2017/352 of the European Parliament and of the Council of 15 February 2017 establishing a framework for the provision of port services and common rules on the financial transparency of ports (OJ EU L 57 3.3.2017, p. 1). (11) Council Directive 96/67/EC of 15 October 1996 on access to the groundhandling market at Community airports (OJ EU L 272, 25.10.1996, p. 36). (12) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ EU L 269, 10.10.2013, p. 1). ANNEX 20 FUTURE MEASURES Headnotes 1. The Schedules of the United Kingdom and the Union set out, under Articles 133, 139 and 195 of this Agreement, the reservations taken by the United Kingdom and the Union with respect to existing measures that do not conform with obligations imposed by: (a) Article 128 or 135 of this Agreement; (b) Article 136 of this Agreement; (c) Article 129 or 137 of this Agreement; (d) Article 130 or 138 of this Agreement; (e) Article 131 of this Agreement; (f) Article 132 of this Agreement; (g) Article 194 of this Agreement. 2. The reservations of a Party are without prejudice to the rights and obligations of the Parties under GATS. 3. Each reservation sets out the following elements: (a) "sector" refers to the general sector in which the reservation is taken; (b) "sub-sector" refers to the specific sector in which the reservation is taken; (c) "industry classification" refers, where applicable, to the activity covered by the reservation according to the CPC, ISIC rev 3.1, or as expressly otherwise described in a Party's reservation; (d) "type of reservation" specifies the obligation referred to in paragraph 1 for which a reservation is taken; (e) "description" sets out the scope of the sector, sub-sector or activities covered by the reservation; and (f) "existing measures" identifies, for transparency purposes, existing measures that apply to the sector, sub-sector or activities covered by the reservation. 4. In the interpretation of a reservation, all elements of the reservation shall be considered. The "description" element shall prevail over all other elements. 5. For the purposes of the Schedules of the United Kingdom and the European Union: (a) "ISIC Rev. 3.1" means the International Standard Industrial Classification of All Economic Activities as set out in Statistical Office of the United Nations, Statistical Papers, Series M, No.4, ISIC Rev. 3.1, 2002; (b) "CPC" means the Provisional Central Product Classification (Statistical Papers, Series M No. 77, Department of International Economic and Social Affairs, Statistical Office of the United Nations, New York,1991). 6. For the purposes of the Schedules of the United Kingdom and the Union, a reservation for a requirement to have a local presence in the territory of the Union or the United Kingdom is taken against Article 136 of this Agreement, and not against Article 135 or 137 of this Agreement. Furthermore, such a requirement is not taken as a reservation against Article 129 of this Agreement. 7. A reservation taken at the level of the Union applies to a measure of the Union, to a measure of a Member State at the central level or to a measure of a government within a Member State, unless the reservation excludes a Member State. A reservation taken by a Member State applies to a measure of a government at the central, regional or local level within that Member State. For the purposes of the reservations of Belgium, the central level of government covers the federal government and the governments of the regions and the communities as each of them holds equipollent legislative powers. For the purposes of the reservations of the Union and its Member States, a regional level of government in Finland means the Åland Islands. A reservation taken at the level of the United Kingdom applies to a measure of the central government, a regional government or a local government. 8. The list of reservations below does not include measures relating to qualification requirements and procedures, technical standards and licensing requirements and procedures where they do not constitute a market access or a national treatment limitation within the meaning of Article 128, 129, 135, 136, 137 or 194 of this Agreement. These measures may include, in particular the need to obtain a licence, to satisfy universal service obligations, to have recognised qualifications in regulated sectors, to pass specific examinations, including language examinations, to fulfil a membership requirement of a particular profession, such as membership in a professional organisation, to have a local agent for service, or to maintain a local address, or any other non-discriminatory requirements that certain activities may not be carried out in protected zones or areas. While not listed, such measures continue to apply. 9. For greater certainty, for the Union, the obligation to grant national treatment does not entail the requirement to extend to natural or legal persons of the United Kingdom the treatment granted in a Member State, pursuant to the Treaty on the Functioning of the European Union, or any measure adopted pursuant to that Treaty, including their implementation in the Member States, to: (a) natural persons or residents of another Member State; or (b) legal persons constituted or organised under the law of another Member State or of the Union and having their registered office, central administration or principal place of business in the Union. 10. Treatment granted to legal persons established by investors of a Party in accordance with the law of the other Party (including, in the case of the Union, the law of a Member State) and having their registered office, central administration or principal place of business within that other Party, is without prejudice to any condition or obligation, consistent with Chapter 2 of Title II of Heading One of Part Two of this Agreement, which may have been imposed on such legal person when it was established in that other Party, and which shall continue to apply. 11. The Schedules apply only to the territories of the United Kingdom and the European Union in accordance with Article 520(2) and Article 774 of this Agreement and are only relevant in the context of trade relations between the Union and its Member States with the United Kingdom. They do not affect the rights and obligations of the Member States under Union law. 12. For greater certainty, non-discriminatory measures do not constitute a market access limitation within the meaning of Article 128, 135 or 194 of this Agreement for any measure: (a) requiring the separation of the ownership of infrastructure from the ownership of the goods or services provided through that infrastructure to ensure fair competition, for example in the fields of energy, transportation and telecommunications; (b) restricting the concentration of ownership to ensure fair competition; (c) seeking to ensure the conservation and protection of natural resources and the environment, including a limitation on the availability, number and scope of concessions granted, and the imposition of a moratorium or ban; (d) limiting the number of authorisations granted because of technical or physical constraints, for example telecommunications spectra and frequencies; or (e) requiring that a certain percentage of the shareholders, owners, partners, or directors of an enterprise be qualified or practice a certain profession such as lawyers or accountants. 13. With respect to financial services: Unlike foreign subsidiaries, branches established directly in a Member State by a non-European Union financial institution are not, with certain limited exceptions, subject to prudential regulations harmonised at European Union level which enable such subsidiaries to benefit from enhanced facilities to set up new establishments and to provide cross-border services throughout the Union. Therefore, such branches receive an authorisation to operate in the territory of a Member State under conditions equivalent to those applied to domestic financial institutions of that Member State, and may be required to satisfy a number of specific prudential requirements such as, in the case of banking and securities, separate capitalisation and other solvency requirements and reporting and publication of accounts requirements or, in the case of insurance, specific guarantee and deposit requirements, a separate capitalisation, and the localisation in the Member State concerned of the assets representing the technical reserves and at least one third of the solvency margin. The following abbreviations are used in the list of reservations below: UK United Kingdom EU European Union, including all its Member States AT Austria BE Belgium BG Bulgaria CY Cyprus CZ Czechia DE Germany DK Denmark EE Estonia EL Greece ES Spain FI Finland FR France HR Croatia HU Hungary IE Ireland IT Italy LT Lithuania LU Luxembourg LV Latvia MT Malta NL The Netherlands PL Poland PT Portugal RO Romania SE Sweden SI Slovenia SK Slovak Republic Schedule of the Union Reservation No. 1 - All sectors Reservation No. 2 - Professional services – other than health related services Reservation No. 3 - Professional services – health related and retail of pharmaceuticals Reservation No. 4 - Business Services - Research and development services Reservation No. 5 - Business Services - Real estate services Reservation No. 6 - Business services - Rental or leasing services Reservation No. 7 - Business Services - Collection agency services and Credit reporting services Reservation No. 8 - Business Services - Placement services Reservation No. 9 - Business Services - Security and investigation services Reservation No. 10 - Business Services - Other business services Reservation No. 11 - Telecommunication Reservation No. 12 - Construction Reservation No. 13 - Distribution services Reservation No. 14 - Education services Reservation No. 15 - Environmental services Reservation No. 16 – Financial Services Reservation No. 17 - Health services and social services Reservation No. 18 - Tourism and travel related services Reservation No. 19 - Recreational, cultural and sporting services Reservation No. 20 - Transport services and auxiliary transport services Reservation No. 21 - Agriculture, fishing and water Reservation No. 22 - Energy related activities Reservation No. 23 - Other services not included elsewhere Reservation No. 1 - All sectors Sector: All sectors Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Performance requirements Local presence Obligations for legal services Chapter/Section: Investment liberalisation, Cross-border trade in services and Regulatory framework for legal services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Establishment With respect to Investment liberalisation – Market access: The EU: Services considered as public utilities at a national or local level may be subject to public monopolies or to exclusive rights granted to private operators. Public utilities exist in sectors such as related scientific and technical consulting services, research and development (R&D) services on social sciences and humanities, technical testing and analysis services, environmental services, health services, transport services and services auxiliary to all modes of transport. Exclusive rights on such services are often granted to private operators, for instance operators with concessions from public authorities, subject to specific service obligations. Given that public utilities often also exist at the sub-central level, detailed and exhaustive sector-specific scheduling is not practical. This reservation does not apply to telecommunications and to computer and related services. With respect to Investment liberalisation – Market access, National treatment; Cross-border trade in services – Market access, National treatment and Regulatory framework for legal services – Obligations: In FI: Restrictions on the right for natural persons, who do not enjoy regional citizenship in Åland, and for legal persons, to acquire and hold real property on the Åland Islands without obtaining permission from the competent authorities of the Åland Islands. Restrictions on the right of establishment and right to carry out economic activities by natural persons, who do not enjoy regional citizenship in Åland, or by any enterprise, without obtaining permission from the competent authorities of the Åland Islands. Existing measures: FI: Ahvenanmaan maanhankintalaki (Act on land acquisition in Åland) (3/1975), s. 2; and Ahvenanmaan itsehallintolaki (Act on the Autonomy of Åland) (1144/1991), s. 11. With respect to Investment liberalisation – Market access, National treatment, Performance requirements, Senior management and boards of directors; Regulatory Framework for legal services – Obligations: In FR: Pursuant to articles L151-1 and 151-1 et seq of the financial and monetary code, foreign investments in France in sectors listed in article R.151-3 of the financial and monetary code are subject to prior approval from the Minister for the Economy. Existing measures: FR: As set out in the description element as indicated above. With respect to Investment liberalisation – National treatment, Senior management and boards of directors: In FR: Limiting foreign participation in newly privatised companies to a variable amount, determined by the government of France on a case by case basis, of the equity offered to the public. For establishing in certain commercial, industrial or artisanal activities, a specific authorisation is needed if the managing director is not a holder of a permanent residence permit. With respect to Investment liberalisation – Market access and Regulatory framework for legal services – Obligations: In HU: Establishment should take a form of limited liability company, joint-stock company or representative office. Initial entry as a branch is not permitted except for financial services. With respect to Investment liberalisation – Market access, National treatment: In BG: Certain economic activities related to the exploitation or use of State or public property are subject to concessions granted under the provisions of the Concessions Act. In commercial corporations in which the State or a municipality holds a share in the capital exceeding 50 per cent, any transactions for disposition of fixed assets of the corporation, to conclude any contracts for acquisition of participating interest, lease, joint activity, credit, securing of receivables, as well as incurring any obligations arising under bills of exchange, are subject to authorisation or permission by the Privatisation Agency or other state or regional bodies, whichever is the competent authority. This reservation does not apply to mining and quarrying, which are subject to a separate reservation in the Schedule of the Union in Annex 19 to this Agreement. In IT: The Government may exercise certain special powers in enterprises operating in the areas of defence and national security, and in certain activities of strategic importance in the areas of energy, transport and communications. This applies to all juridical persons carrying out activities considered of strategic importance in the areas of defence and national security, not only to privatised companies. If there is a threat of serious injury to the essential interests of defence and national security, the Government has following special powers to: (a) to impose specific conditions in the purchase of shares; (b) to veto the adoption of resolutions relating to special operations such as transfers, mergers, splitting up and changes of activity; or (c) to reject the acquisition of shares, where the buyer seeks to hold a level of participation in the capital that is likely to prejudice the interests of defence and national security. Any resolution, act or transaction (such as transfers, mergers, splitting up, change of activity or termination) relating to strategic assets in the areas of energy, transport and communications shall be notified by the concerned company to the Prime Minister's office. In particular, acquisitions by any natural or juridical person outside the European Union that give this person control over the company shall be notified. The Prime Minister may exercise the following special powers: (a) to veto any resolution, act and transaction that constitutes an exceptional threat of serious injury to the public interest in the security and operation of networks and supplies; (b) to impose specific conditions in order to guarantee the public interest; or (c) to reject an acquisition in exceptional cases of risk to the essential interests of the State. The criteria on which to evaluate the real or exceptional threat and conditions and procedures for the exercise of the special powers are laid down in the law. Existing measures: IT: Law 56/2012 on special powers in companies operating in the field of defence and national security, energy, transport and communications; and Decree of the Prime Minister DPCM 253 of 30.11.2012 defining the activities of strategic importance in the field of defence and national security. With respect to Investment liberalisation – Market access, National treatment, Most-favoured nation treatment, Performance requirements, Senior management and boards of directors: In LT: Enterprises, sectors and facilities of strategic importance to national security. Existing measures: LT: Law on the Protection of Objects of Importance to Ensuring National Security of the Republic of Lithuania of 10 October 2002 No. IX-1132 (as last amended on 12 of January 2018 No XIII-992). With respect to Investment liberalisation – National treatment and Senior management and boards of directors: In SE: Discriminatory requirements for founders, senior management and boards of directors when new forms of legal association are incorporated into Swedish law. (b) Acquisition of real estate With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors: In HU: The acquisition of state-owned properties. With respect to Investment liberalisation – Market access, National treatment: In HU: The acquisition of arable land by foreign legal persons and non-resident natural persons. Existing measures: HU: Act CXXII of 2013 on the circulation of agricultural and forestry land (Chapter II (Paragraph 6-36) and Chapter IV (Paragraph 38-59)); and Act CCXII of 2013 on the transitional measures and certain provisions related to Act CXXII of 2013 on the circulation of agricultural and forestry land (Chapter IV (Paragraph 8-20)). In LV: The acquisition of rural land by nationals of the United Kingdom or of a third country. Existing measures: LV: Law on land privatisation in rural areas, ss. 28, 29, 30. In SK: Foreign companies or natural persons may not acquire agricultural and forest land outside the borders of the built-up area of a municipality and some other land (e.g. natural resources, lakes, rivers, public roads etc.). Existing measures: SK: Act No 44/1988 on protection and exploitation of natural resources; Act No 229/1991 on regulation of the ownership of land and other agricultural property; Act No 460/1992 Constitution of the Slovak Republic; Act No 180/1995 on some measures for land ownership arrangements; Act No 202/1995 on Foreign Exchange; Act No 503/2003 on restitution of ownership to land; Act No 326/2005 on Forests; and Act No 140/2014 on the acquisition of ownership of agricultural land. With respect to Investment liberalisation – National treatment and Cross-border trade in services – Local presence: In BG: Foreign natural and legal persons cannot acquire land. Legal persons of Bulgaria with foreign participation cannot acquire agricultural land. Foreign legal persons and foreign natural persons with permanent residence abroad can acquire buildings and real estate property rights (right to use, right to build, right to raise a superstructure and servitudes). Foreign natural persons with permanent residence abroad, foreign legal persons in which foreign participation ensures a majority in adopting decisions or blocks the adoption of decisions, can acquire real estate property rights in specific geographic regions designated by the Council of Ministers subject to permission. BG: Constitution of the Republic of Bulgaria, article 22; Law on Ownership and Use of Agricultural Land, article 3; and Law on Forests, article 10. In EE: Foreign natural or legal persons that are not from the EEA or from members of the Organisation for Economic Co-operation and Development can acquire an immovable asset which contains agricultural and/or forest land only with the authorisation of the county governor and of the municipal council, and must prove as prescribed by law that the immovable asset will, according to its intended purpose, be used efficiently, sustainably and purposefully. Existing measures: EE: Kinnisasja omandamise kitsendamise seadus (Restrictions on Acquisition of Immovables Act) Chapters 2 and 3. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services - Market access, National treatment: In LT: Any measure which is consistent with the commitments taken by the European Union and which are applicable in Lithuania in GATS with respect to land acquisition. The land plot acquisition procedure, terms and conditions, as well as restrictions shall be established by the Constitutional Law, the Law on Land and the Law on the Acquisition of Agricultural Land. However, local governments (municipalities) and other national entities of Members of the Organisation for Economic Co-operation and Development and North Atlantic Treaty Organization conducting economic activities in Lithuania, which are specified by the constitutional law in compliance with the criteria of European Union and other integration which Lithuania has embarked on, are permitted to acquire into their ownership non-agricultural land plots required for the construction and operation of buildings and facilities necessary for their direct activities. Existing measures: LT: Constitution of the Republic of Lithuania; The Constitutional Law of the Republic of Lithuania on the Implementation of Paragraph 3 of Article 47 of the Constitution of the Republic of Lithuania of 20 June 1996, No. I-1392 as last amended 20 March 2003, No. IX-1381; Law on land, of 27 January 2004, No. IX-1983; and Law on acquisition of agricultural land of 24 April 2014, No. XII-854. (c) Recognition With respect to Investment liberalisation –National treatment and Cross-border trade in services – National treatment: In EU: The Union directives on mutual recognition of diplomas and other professional qualification only apply to the citizens of the Union. The right to practise a regulated professional service in one Member State does not grant the right to practise in another Member State. (d) Most-favoured-nation treatment With respect to Investment liberalisation – Most-favoured-nation treatment and Cross-border trade in services – Most-favoured-nation treatment and Regulatory framework for legal services – Obligations: The EU: According differential treatment to a third country pursuant to any international investment treaties or other trade agreement in force or signed prior to the date of entry into force of this Agreement. The EU: According differential treatment to a third country pursuant to any existing or future bilateral or multilateral agreement which: (i) creates an internal market in services and investment; (ii) grants the right of establishment; or (iii) requires the approximation of legislation in one or more economic sectors. An internal market in services and investment means an area without internal frontiers in which the free movement of services, capital and persons is ensured. The right of establishment means an obligation to abolish in substance all barriers to establishment among the parties to the bilateral or multilateral agreement by the entry into force of that agreement. The right of establishment shall include the right of nationals of the parties to the bilateral or multilateral agreement to set up and operate enterprises under the same conditions provided for nationals under the law of the party where such establishment takes place. The approximation of legislation means: (i) the alignment of the legislation of one or more of the parties to the bilateral or multilateral agreement with the legislation of the other party or parties to that agreement; or (ii) the incorporation of common legislation into the law of the parties to the bilateral or multilateral agreement. Such alignment or incorporation shall take place, and shall be deemed to have taken place, only at such time that it has been enacted in the law of the party or parties to the bilateral or multilateral agreement. Existing measures: EU: Agreement on the European Economic Area; Stabilisation Agreements; EU-Swiss Confederation bilateral agreements; and Deep and Comprehensive Free Trade Agreements. The EU: According differential treatment relating to the right of establishment to nationals or enterprises through existing or future bilateral agreements between the following Member States: BE, DE, DK, EL, ES, FR, IE, IT, LU, NL, PT and any of the following countries or principalities: Andorra, Monaco, San Marino and the Vatican City State. In DK, FI, SE: Measures taken by Denmark, Sweden and Finland aimed at promoting Nordic cooperation, such as: (a) financial support to research and development (R&D) projects (the Nordic Industrial Fund); (b) funding of feasibility studies for international projects (the Nordic Fund for Project Exports); and (c) financial assistance to companies utilizing environmental technology (the Nordic Environment Finance Corporation). The purpose of the Nordic Environment Finance Corporation (NEFCO) is to promote investments of Nordic environmental interest, with a focus on Eastern Europe. This reservation is without prejudice to the exclusion of procurement by a Party or subsidies in Article 123(6) and (7) of this Agreement. In PL: Preferential conditions for establishment or the cross-border supply of services, which may include the elimination or amendment of certain restrictions embodied in the list of reservations applicable in Poland, may be extended through commerce and navigation treaties. In PT: Waiving nationality requirements for the exercise of certain activities and professions by natural persons supplying services for countries in which Portuguese is the official language (Angola, Brazil, Cape Verde, Guinea-Bissau, Equatorial Guinea, Mozambique, São Tomé & Principe, and East Timor). (e) Arms, munition and war material With respect to Investment liberalisation – Market access, National treatment, Most-favoured nation treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services – Market access, National treatment, Most-favoured-nation treatment, Local presence: In EU: Production or distribution of, or trade in, arms, munitions and war material. War material is limited to any product which is solely intended and made for military use in connection with the conduct of war or defence activities. Reservation No. 2 - Professional services - other than health related services Sector: Professional services - legal services: services of notaries and by bailiffs; accounting and bookkeeping services; auditing services, taxation advisory services; architecture and urban planning services, engineering services, and integrated engineering services Industry classification: Part of CPC 861, part of 87902, 862, 863, 8671, 8672, 8673, 8674, part of 879 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Legal services With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access, National treatment: The EU, with the exception of SE: The supply of legal advisory and legal authorisation, documentation, and certification services provided by legal professionals entrusted with public functions, such as notaries, "huissiers de justice" or other "officiers publics et ministériels", and with respect to services provided by bailiffs who are appointed by an official act of government (part of CPC 861, part of 87902). With respect to Investment liberalisation – Most-favoured-nation treatment and Cross-border trade in services – Most-favoured-nation treatment: In BG: Full national treatment on the establishment and operation of companies, as well as on the supply of services, may be extended only to companies established in, and citizens of, the countries with whom preferential arrangements have been or will be concluded (part of CPC 861). In LT: Attorneys from foreign countries can participate as advocates in court only in accordance with international agreements (part of CPC 861), including specific provisions regarding representation before courts. (b) Accounting and bookkeeping services (CPC 8621 other than auditing services, 86213, 86219, 86220) With respect to Cross-border trade in services – Market access: In HU: Cross-border activities for accounting and bookkeeping. Existing measures: HU: Act C of 2000; and Act LXXV of 2007. (c) Auditing services (CPC – 86211, 86212 other than accounting and bookkeeping services) With respect to Cross-border trade in services - National treatment: In BG: An independent financial audit shall be implemented by registered auditors who are members of the Institute of the Certified Public Accountants. Subject to reciprocity, the Institute of the Certified Public Accountants shall register an audit entity of the United Kingdom or of a third country upon the latter furnishing proof that: (a) three-fourths of the members of the management bodies and the registered auditors carrying out audit on behalf of the entity meet requirements equivalent to those for Bulgarian auditors and have passed successfully the examinations for it; (b) the audit entity carries out independent financial audit in accordance with the requirements for independence and objectivity; and (c) the audit entity publishes on its website an annual transparency report or performs other equivalent requirements for disclosure in case it audits public-interest entities. Existing Measures: BG: Independent Financial Audit Act. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors: In CZ: Only a legal person in which at least 60 per cent of capital interests or voting rights are reserved to nationals of the Czech Republic or of the Member States of the European Union is authorised to carry out audits in the Czech Republic. Existing Measures: CZ: Law of 14 April 2009 no. 93/2009 Coll., on Auditors. With respect to Cross-border trade in services – Market access: In HU: Cross-border supply of auditing services. Existing Measures: HU: Act C of 2000; and Act LXXV of 2007. In PT: Cross-border supply of auditing services. (d) Architecture and urban planning services (CPC 8674) With respect to Cross-border trade in services – Market access, National treatment: In HR: The cross-border supply of urban planning. Reservation No. 3 - Professional services – health related and retail of pharmaceuticals Sector: Health related professional services and retail sales of pharmaceutical, medical and orthopaedic goods, other services provided by pharmacists Industry classification: CPC 63211, 85201, 9312, 9319, 93121 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Medical and dental services; services provided by midwives, nurses, physiotherapists, psychologists and paramedical personnel (CPC 63211, 85201, 9312, 9319, CPC 932) With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access and National treatment: In FI: The supply of all health-related professional services, whether publicly or privately funded, including medical and dental services, services provided by midwives, physiotherapists and paramedical personnel and services provided by psychologists, excluding services provided by nurses (CPC 9312, 93191). Existing measures: FI: Laki yksityisestä terveydenhuollosta (Act on Private Health Care) (152/1990). In BG: The supply of all health-related professional services, whether publicly or privately funded, including medical and dental services, services provided by nurses, midwives, physiotherapists and paramedical personnel and services provided by psychologists (CPC 9312, part of 9319). Existing Measures: BG: Law for Medical Establishment, Professional Organisation of Medical Nurses, Midwives and Associated Medical Specialists Guild Act. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access and National treatment: In CZ, MT: The supply of all health-related professional services, whether publicly or privately funded, including the services provided by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, psychologists, as well as other related services (CPC 9312, part of 9319). Existing Measures: CZ: Act No 296/2008 Coll., on Safeguarding the Quality and Safety of Human Tissues and Cells Intended for Use in Man ("Act on Human Tissues and Cells"); Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals); Act No. 268/2014 Coll. on medical devices and amending Act No 634/2004 Coll. on administrative fees, as subsequently amended; Act No. 285/2002 Coll., on the Donating, Taking and Transplanting of Tissues and Organs and on Amendment to Certain Acts (Transplantation Act). Act No. 372/2011 Coll., on health services and on conditions of their provision Act No. 373/2011 Coll., on specific health services). With respect to Cross-border trade in services – Market access, National treatment, Local presence: The EU, with the exception of NL and SE: The supply of all health-related professional services, whether publicly or privately funded, including the services provided by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, and psychologists, requires residency. These services may only be provided by natural persons physically present in the territory of the European Union (CPC 9312, part of 93191). In BE: The cross-border supply whether publicly or privately funded of all health-related professional services, including medical, dental and midwives services and services provided by nurses, physiotherapists, psychologists and paramedical personnel. (part of CPC 85201, 9312, part of 93191). In PT: (Also with respect to Most-favoured nation treatment) Concerning the professions of physiotherapists, paramedical personnel and podiatrists, foreign professionals may be allowed to practice based on reciprocity. (b) Veterinary services (CPC 932) With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services –National treatment, Local presence: In BG: A veterinary medical establishment may be established by a natural or a legal person. The practice of veterinary medicine is only allowed for nationals of the EEA and for permanent residents (physical presence is required for permanent residents). With respect to Cross-border trade in services – Market access, National treatment: In BE, LV: Cross-border supply of veterinary services. (c) Retail sales of pharmaceutical, medical and orthopaedic goods, other services provided by pharmacists (CPC 63211) With respect to Investment liberalisation – Market access and Cross-border trade in services – Local presence: The EU, with the exception of EL, IE, LU, LT and NL: For restricting the number of suppliers entitled to provide a particular service in a specific local zone or area on a non-discriminatory basis. An economic needs test may therefore be applied, taking into account such factors as the number of and impact on existing establishments, transport infrastructure, population density or geographic spread. The EU, with the exception of BE, BG, EE, ES, IE and IT: Mail order is only possible from Member States of the EEA, thus establishment in any of those countries is required for the retail of pharmaceuticals and specific medical goods to the general public in the Union. In CZ: Retail sales are only possible from Member States. In BE: The retail sales of pharmaceuticals and specific medical goods are only possible from a pharmacy established in Belgium. In BG, EE, ES, IT and LT: Cross-border retail sales of pharmaceuticals. In IE and LT: Cross-border retail of pharmaceuticals requiring a prescription. In PL: Intermediaries in the trade of medicinal products must be registered and have a place of residence or registered office in the territory of the Republic of Poland. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services – Market access, National treatment: In FI: Retail sales of pharmaceutical products and of medical and orthopaedic goods. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access, National treatment: In SE: Retail sales of pharmaceutical goods and the supply of pharmaceutical goods to the general public. Existing measures: AT: Arzneimittelgesetz (Medication Act), BGBl. Nr. 185/1983 as amended, §§ 57, 59, 59a; and Medizinproduktegesetz (Medical Products Law), BGBl. Nr. 657/1996 as amended, § 99. BE: Arrêté royal du 21 janvier 2009 portant instructions pour les pharmaciens; and Arrêté royal du 10 novembre 1967 relatif à l'exercice des professions des soins de santé. CZ: Act No. 378/2007 Coll., on Pharmaceuticals, as amended; and Act No. 372/2011 Coll., on Health services, as amended. FI: Lääkelaki (Medicine Act) (395/1987). PL: Pharmaceutical Law, art. 73a (Journal of Laws of 2020, item 944, 1493). SE: Law on trade with pharmaceuticals (2009:336); Regulation on trade with pharmaceuticals (2009:659); and The Swedish Medical Products Agency has adopted further regulations, the details can be found at (LVFS 2009:9). Reservation No. 4 - Business Services - Research and development services Sector: Research and development services Industry classification: CPC 851, 852, 853 Type of reservation: Market access National treatment Chapter: Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: In RO: Cross-border supply of research and development services. Existing measures: RO: Governmental Ordinance no. 6 / 2011; Order of Minister of Education and Research no. 3548 / 2006; and Governmental Decision no. 134 / 2011. Reservation No. 5 - Business Services - Real estate services Sector: Real estate services Industry classification: CPC 821, 822 Type of reservation: Market access National treatment Chapter: Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: In CZ and HU: Cross-border supply of real estate services. Reservation No. 6 - Business services - Rental or leasing services Sector: Rental or leasing services without operators Industry classification: CPC 832 Type of reservation: Market access National treatment Chapter: Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: In BE and FR: Cross-border supply of leasing or rental services without operator concerning personal and household goods. Reservation No. 7 - Business Services - Collection agency services and Credit reporting services Sector: Collection agency services, credit reporting services Industry classification: CPC 87901, 87902 Type of reservation: Market access National treatment Local presence Chapter: Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: The EU, with the exception of ES, LV and SE, with regard to the supply of collection agency services and credit reporting services. Reservation No. 8 - Business Services - Placement services Sector – sub-sector: Business Services – placement services Industry classification: CPC 87201, 87202, 87203, 87204, 87205, 87206, 87209 Type of reservation: Market access National treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access, National treatment, Local presence: In the EU, with the exception of HU and SE: Supply services of domestic help personnel, other commercial or industrial workers, nursing and other personnel (CPC 87204, 87205, 87206, 87209). In BG, CY, CZ, DE, EE, FI, MT, LT, LV, PL, PT, RO, SI and SK: Executive search services (CPC 87201). In AT, BG, CY, CZ, EE, FI, LT, LV MT, PL, PT, RO, SI and SK: The establishment of placement services of office support personnel and other workers (CPC 87202). In AT, BG, CY, CZ, DE, EE, FI, MT, LT, LV, PL, PT, RO, SI and SK: Supply services of office support personnel (CPC 87203). With respect to Cross-border trade in services – Market access, National treatment, Local presence: In the EU with the exception of BE, HU and SE: The cross-border supply of placement services of office support personnel and other workers (CPC 87202). In IE: The cross-border supply of executive search services (CPC 87201). In FR, IE, IT and NL: The cross-border supply of services of office personnel (CPC 87203). With respect to Investment liberalisation – Market access and Cross-border trade in services – Market access In DE : To restrict the number of suppliers of placement services. In ES: To restrict the number of suppliers of executive search services and placement services (CPC 87201, 87202). In FR: These services can be subject to a state monopoly (CPC 87202). In IT: To restrict the number of suppliers of supply services of office personnel (CPC 87203). With respect to Investment liberalisation –Market access, National treatment: In DE: The Federal Ministry of Labour and Social Affairs may issue a regulation concerning the placement and recruitment of non-European Union and non-EEA personnel for specified professions (CPC 87201, 87202, 87203, 87204, 87205, 87206, 87209). Existing measures: AT: §§97 and 135 of the Austrian Trade Act (Gewerbeordnung), Federal Law Gazette Nr. 194/1994 as amended; and Temporary Employment Act (Arbeitskräfteüberlassungsgesetz/AÜG), Federal Law Gazette Nr. 196/1988 as amended. BG: Employment Promotion Act, articles 26, 27, 27a and 28. CY: Private Employment Agency Law N. 126(I)/2012 as amended. CZ: Act on Employment (435/2004). DE: Gesetz zur Regelung der Arbeitnehmerüberlassung (AÜG); Sozialgesetzbuch Drittes Buch (SGB III; Social Code, Book Three) - Employment Promotion; Verordnung über die Beschäftigung von Ausländerinnen und Ausländern (BeschV; Ordinance on the Employment of Foreigners). DK: §§ 8a – 8f in law decree no. 73 of 17th of January 2014 and specified in decree no. 228 of 7th of March 2013 (employment of seafarers); and Employment Permits Act 2006. S1(2) and (3). EL: Law 4052/2012 (Official Government Gazette 41 Α) as amended to some of its provision by the law Ν.4093/2012 (Official Government Gazette 222 Α). ES: Real Decreto-ley 8/2014, de 4 de julio, de aprobación de medidas urgentes para el crecimiento, la competitividad y la eficiencia, artículo 117 (tramitado como Ley 18/2014, de 15 de octubre). FI: Laki julkisesta työvoima-ja yrityspalvelusta (Act on Public Employment and Enterprise Service) (916/2012). HR: Labour Market Act (OG 118/18, 32/20) Labour Act (OG 93/14, 127/17, 98/19) Aliens Act (OG 130/11m 74/13, 67/17, 46/18, 53/20) IE: Employment Permits Act 2006. S1(2) and (3). IT: Legislative Decree 276/2003 articles 4, 5. LT: Lithuanian Labour Code of the Republic of Lithuania approved by Law No XII-2603 of 14 September 2016 of the Republic of Lithuania, The Law on the Legal Status of Aliens of the Republic of Lithuania of 29 April 2004 No. IX-2206 as last amended 03-12-2019 No. XIII-2582. LU: Loi du 18 janvier 2012 portant création de l'Agence pour le développement de l'emploi (Law of 18 January 2012 concerning the creation of an agency for employment development – ADEM). MT: Employment and Training Services Act, (Cap 343) (Articles 23 to 25); and Employment Agencies Regulations (S.L. 343.24). PL: Article 18 of the Act of 20 April 2004 on the promotion of employment and labour market institutions (Dz. U. of 2015, Item. 149, as amended). PT: Decree-Law No 260/2009 of 25 September, as amended by Law No. 5/2014 of 12 February (access and provision of services by placement agencies). RO: Law no. 156/2000 on the protection of Romanian citizens working abroad, republished, and Government Decision no. 384/2001 for approving the methodological norms for applying the Law no. 156/2000, with subsequent amendments; Ordinance of the Government no. 277/2002, as modified by Government Ordinance No. 790/2004 and Government Ordinance No. 1122/2010; and Law no.53/2003 - Labour Code, republished, with subsequent amendments and supplement and the Government Decision no 1256/2011 on the operating conditions and authorization procedure for temporary work agency. SI: Labour market regulation act (Official Gazette of RS, No. 80/2010, 21/2013, 63/2013, 55/2017); and Employment, Self-employment and Work of Aliens Act – ZZSDT (Official Gazette of RS, No. 47/2015), ZZSDT-UPB2 (Official Gazette of RS, No. 1 /2018). SK: Act No 5/2004 on Employment Services; and Act No 455/1991on Trade Licensing. Reservation No. 9 - Business Services - Security and investigation services Sector– sub-sector: Business services – security and investigation services Industry classification: CPC 87301, 87302, 87303, 87304, 87305, 87309 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Security services (CPC 87302, 87303, 87304, 87305, 87309) With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services – Market access, National treatment: In BG, CY, CZ, EE, ES, LT, LV, MT, PL, RO, SI and SK: The supply of security services. In DK, HR and HU: The supply of the following subsectors: guard services (87305) in HR and HU, security consultation services (87302) in HR, airport guard services (part of 87305) in DK and armoured car services (87304) in HU. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services –National treatment, Local presence: In BE: Nationality of a Member State is required for boards of directors of enterprises legal persons supplying guard and security services (87305) as well as consultancy and training relating to security services (87302). The senior management of companies providing guard and security consultancy services required to be resident nationals of a Member State. In FI: Licences to supply security services may be granted only to natural persons resident in the EEA or legal persons established in the EEA. In ES: The cross border supply of security services. Nationality requirements exist for private security personnel. With respect to Cross-border trade in services – Market access, National treatment: In BE, FI, FR and PT: The supply of security services by a foreign provider on a cross-border basis is not allowed. Nationality requirements exist for specialised personnel in PT and for managing directors and directors in FR. Existing measures: BE: Loi réglementant la sécurité privée et particulière, 2 Octobre 2017. BG: Private Security Business Act. CZ: Trade Licensing Act. DK: Regulation on aviation security. FI: Laki yksityisistä turvallisuuspalveluista 282/2002 (Private Security Services Act). LT: Law on security of Persons and Assets 8 July 2004 No. IX-2327. LV: Security Guard Activities Law (Sections 6, 7, 14). PL: Act of 22 August 1997 on the protection of persons and property (Journal of Laws of 2016, item 1432 as amended). PT: Law 34/2013 alterada p/ Lei 46/2019, 16 maio; and Ordinance 273/2013 alterada p/ Portaria 106/2015, 13 abril. SI: Zakon o zasebnem varovanju (Law on private security). (b) Investigation services (CPC 87301) With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services – Market access, National treatment, Local presence: The EU, with the exception of AT and SE: The supply of investigation services. With respect to Investment liberalisation - Market access and Cross-border trade in services – Market access: In LT and PT: Investigation services are a monopoly reserved to the State. Reservation No. 10 - Business Services - Other business services Sector– sub-sector: Business services – other business services (translation and interpretation services, duplicating services, services incidental to energy distribution and services incidental to manufacturing) Industry classification: CPC 87905, 87904, 884, 887 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Translation and interpretation services (CPC 87905) With respect to Cross-border trade in services – Market access, National treatment: In HR: Cross-border supply of translation and interpretation of official documents. (b) Duplicating services (CPC 87904) With respect to Cross-border trade in services – Market access, National treatment, Local presence: In HU: Cross-border supply of duplicating services. (c) Services incidental to energy distribution and services incidental to manufacturing (Part of CPC 884, 887 other than advisory and consulting services) With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access, National treatment, Local presence: In HU: Services incidental to energy distribution, and cross-border supply of services incidental to manufacturing, with the exception of advisory and consulting services relating to these sectors. (d) Maintenance and repair of vessels, rail transport equipment and aircraft and parts thereof (part of CPC 86764, CPC 86769, CPC 8868) With respect to Cross-border trade in services – Market access, National treatment, Local presence: In EU, with the exception of DE, EE and HU: The cross-border supply of maintenance and repair services of rail transport equipment. In EU, with the exception of CZ, EE, HU, LU and SK: Cross-border supply of maintenance and repair services of inland waterway transport vessels. In EU, with the exception of EE, HU and LV: The cross-border supply of maintenance and repair services of maritime vessels. In EU, with the exception of AT, EE, HU, LV, and PL: The cross-border supply of maintenance and repair services of aircraft and parts thereof (part of CPC 86764, CPC 86769, CPC 8868). In EU: The cross-border supply of services of statutory surveys and certification of ships. Existing measures: EU: Regulation (EC) No 391/2009 of the European Parliament and the Council (1). (e) Other business services related to aviation With respect to Investment liberalisation – Most-favoured-nation treatment and Cross-border trade in services – Most-favoured-nation treatment: The EU: According differential treatment to a third country pursuant to existing or future bilateral agreements relating to the following services: (a) the selling and marketing of air transport services; (b) computer reservation system (CRS) services; (c) maintenance and repair of aircrafts and parts, (d) rental or leasing of aircraft without crew. With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of director, and Cross-border trade in services – Market access, National treatment, Local presence: In DE, FR: Aerial fire-fighting, flight training, spraying, surveying, mapping, photography, and other airborne agricultural, industrial and inspection services. In FI, SE: Aerial fire-fighting. Reservation No. 11 - Telecommunication Sector: Satellite broadcast transmission services Industry classification: Type of reservation: Market access National treatment Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: In BE: Satellite broadcast transmission services. Reservation No. 12 - Construction Sector: Construction services Industry classification: CPC 51 Type of reservation: Market access National treatment Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: In LT: The right to prepare design documentation for construction works of exceptional significance is only given to a design enterprise registered in Lithuania or a foreign design enterprise which has been approved by an institution authorised by the Government for those activities. The right to perform technical activities in the main areas of construction may be granted to a non-Lithuanian person who has been approved by an institution authorised by the Government of Lithuania. Reservation No. 13 - Distribution services Sector: Distribution services Industry classification: CPC 62117, 62251, 8929, part of 62112, 62226, part of 631 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Distribution of pharmaceuticals With respect to Cross-border trade in services – Market access, National treatment: In BG: Cross-border wholesale distribution of pharmaceuticals (CPC 62251). With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of director, and Cross-border trade in services – Market access, National treatment: In FI: Distribution of pharmaceutical products (CPC 62117, 62251, 8929). Existing measures: BG: Law on Medicinal Products in Human Medicine; Law on Medical Devices. FI: Lääkelaki (Medicine Act) (395/1987). (b) Distribution of alcoholic beverages In FI: Distribution of alcoholic beverages (part of CPC 62112, 62226, 63107, 8929). Existing measures: FI: Alkoholilaki (Alcohol Act) (1102/2017). With respect to Investment liberalisation – Market access and Cross-border trade in services – Market access: In SE: Imposing a monopoly on retail sales of liquor, wine and beer (except non-alcoholic beer). Currently Systembolaget AB has such governmental monopoly on retail sales of liquor, wine and beer (except non-alcoholic beer). Alcoholic beverages are beverages with an alcohol content over 2.25 per cent per volume. For beer, the limit is an alcohol content over 3.5 per cent per volume (part of CPC 631). Existing measures: SE: The Alcohol Act (2010:1622). (c) Other distribution (part of CPC 621, CPC 62228, CPC 62251, CPC 62271, part of CPC 62272, CPC 62276, CPC 63108, part of CPC 6329) With respect to Cross-border trade in services – Market access, National treatment: In BG: Wholesale distribution of chemical products, precious metals and stones, medical substances and products and objects for medical use; tobacco and tobacco products and alcoholic beverages. Bulgaria reserves the right to adopt or maintain any measure with respect to the services provided by commodity brokers. Existing measures: In BG: Law on Medicinal Products in Human Medicine; Law on Medical Devices; Law of Veterinary Activity; Law for Prohibition of Chemical Weapons and for Control over Toxic Chemical Substances and Their Precursors; Law for Tobacco and Tobacco Products. Law on excise duties and tax warehouses and Law on wine and spirits. Reservation No. 14 - Education services Sector: Education services Industry classification: CPC 92 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of director, and Cross-border trade in services – Market access, National treatment, Local presence: The EU: Educational services which receive public funding or State support in any form. Where the supply of privately funded education services by a foreign provider is permitted, participation of private operators in the education system may be subject to concession allocated on a non-discriminatory basis. The EU, with the exception of CZ, NL, SE and SK: With respect to the supply of privately funded other education services, which means other than those classified as being primary, secondary, higher and adult education services (CPC 929). In CY, FI, MT and RO: The supply of privately funded primary, secondary, and adult education services (CPC 921, 922, 924). In AT, BG, CY, FI, MT and RO: The supply of privately funded higher education services (CPC 923). In CZ and SK: The majority of the members of the board of directors of an establishment providing privately funded education services must be nationals of that country (CPC 921, 922, 923 for SK other than 92310, 924). In SI: Privately funded elementary schools may be founded by Slovenian natural or legal persons only. The service supplier must establish a registered office or a branch. The majority of the members of the board of directors of an establishment providing privately funded secondary or higher education services must be Slovenian nationals (CPC 922, 923). In SE: Educational services suppliers that are approved by public authorities to provide education. This reservation applies to privately funded educational services suppliers with some form of State support, inter alia educational service suppliers recognised by the State, educational services suppliers under State supervision or education which entitles to study support (CPC 92). In SK: EEA residency is required for suppliers of all privately funded education services other than post-secondary technical and vocational education services. An economic needs test may apply and the number of schools being established may be limited by local authorities (CPC 921, 922, 923 other than 92310, 924). With respect to Cross-border trade in services – Market access, National treatment, Local presence: In BG, IT and SI: To restrict the cross-border supply of privately funded primary education services (CPC 921). In BG and IT: To restrict the cross-border supply of privately funded secondary education services (CPC 922). In AT: To restrict the cross-border supply of privately funded adult education services by means of radio or television broadcasting (CPC 924). Existing measures: BG: Public Education Act, article 12; Law for the Higher Education, paragraph 4 of the additional provisions; and Vocational Education and Training Act, article 22. FI: Perusopetuslaki (Basic Education Act) (628/1998); Lukiolaki (General Upper Secondary Schools Act) (629/1998); Laki ammatillisesta koulutuksesta (Vocational Training and Education Act) (630/1998); Laki ammatillisesta aikuiskoulutuksesta (Vocational Adult Education Act) (631/1998); Ammattikorkeakoululaki (Polytechnics Act) (351/2003); and Yliopistolaki (Universities Act) (558/2009). IT: Royal Decree 1592/1933 (Law on secondary education); Law 243/1991 (Occasional public contribution for private universities); Resolution 20/2003 of CNVSU (Comitato nazionale per la valutazione del sistema universitario); and Decree of the President of the Republic (DPR) 25/1998. SK: Act 245/2008 on education; Act 131/2002 on Universities; and Act 596/2003 on State Administration in Education and School Self- Administration. Reservation No. 15 - Environmental services Sector– sub-sector: Environmental services – waste and soil management Industry classification: CPC 9401, 9402, 9403, 94060 Type of reservation: Market access Chapter: Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: In DE: The supply of waste management services other than advisory services, and with respect to services relating to the protection of soil and the management of contaminated soils, other than advisory services. Reservation No. 16 - Financial services Sector: Financial services Industry classification: Not applicable Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) All Financial Services With respect to Investment liberalisation – Market access The EU: the right to require a financial service supplier, other than a branch, when establishing in a Member State to adopt a specific legal form, on a non-discriminatory basis. With respect to Cross-border trade in services – Market access, National treatment, Local presence The EU: the right to adopt or maintain any measure with respect to the cross-border supply of all financial services other than: In EU (except for BE, CY, EE, LT, LV, MT, PL, RO, SI): (i) direct insurance services (including co-insurance) and direct insurance intermediation for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (v) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In BE: (i) direct insurance services (including co-insurance) and direct insurance intermediation for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; In CY: (i) direct insurance services (including co-insurance) for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) Insurance intermediation; (iii) Reinsurance and retrocession; (iv) Services auxiliary to insurance; (v) the trading for own account or for the account of customers, whether on an exchange or an over-the-counter market or otherwise of transferrable securities; (vi) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (vii) advisory and other auxiliary financial services, relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In EE: (i) direct insurance (including co-insurance); (ii) reinsurance and retrocession; (iii) insurance intermediation; (iv) services auxiliary to insurance; (v) acceptance of deposits; (vi) lending of all types; (vii) financial leasing; (viii) all payment and money transmission services; guarantees and commitments; (ix) trading for own account or for account of customers, whether on an exchange, in an over-the-counter market; (x) participation in issues of all kinds of securities, including underwriting and placement as agent (whether publicly or privately) and provision of services related to such issues; (xi) money broking; (xii) asset management, such as cash or portfolio management, all forms of collective investment management, custodial, depository and trust services; (xiii) settlement and clearing services for financial assets, including securities, derivative products, and other negotiable instruments; (xiv) provision and transfer of financial information, and financial data processing and related software; and (xv) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In LT: (i) direct insurance services (including co-insurance) for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) acceptance of deposits; (v) lending of all types; (vi) financial leasing; (vii) all payment and money transmission services; guarantees and commitments; (viii) trading for own account or for account of customers, whether on an exchange, in an over-the-counter market; (ix) participation in issues of all kinds of securities, including underwriting and placement as agent (whether publicly or privately) and provision of services related to such issues; (x) money broking; (xi) asset management, such as cash or portfolio management, all forms of collective investment management, custodial, depository and trust services; (xii) settlement and clearing services for financial assets, including securities, derivative products, and other negotiable instruments; (xiii) provision and transfer of financial information, and financial data processing and related software; and (xiv) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In LV: (i) direct insurance services (including co-insurance) for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) participation in issues of all kinds of securities, including underwriting and placement as agent (whether publicly or privately) and provision of services related to such issues; (v) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (vi) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In MT: (i) direct insurance services (including co-insurance) for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) the acceptance of deposits; (v) lending of all types; (vi) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (vii) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In PL: (i) direct insurance services (including co-insurance) for the insurance of risks relating to goods in international trade; (ii) reinsurance and retrocession of risks relating to goods in international trade; (iii) direct insurance services (including co-insurance and retrocession) and direct insurance intermediation for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (iv) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (v) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In RO: (i) direct insurance services (including co-insurance) and direct insurance intermediation for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) acceptance of deposits; (v) lending of all types; (vi) guarantees and commitments; (vii) money broking; (viii) the provision and transfer of financial information, and financial data processing and related software; and (ix) advisory and other auxiliary financial services relating to banking and other financial services as described in in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. In SI: (i) direct insurance services (including co-insurance) and direct insurance intermediation for the insurance of risks relating to: a. maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and b. goods in international transit; (ii) reinsurance and retrocession; (iii) services auxiliary to insurance; (iv) lending of all types; (v) the acceptance of guarantees and commitments from foreign credit institutions by domestic legal entities and sole proprietors; (vi) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (ix) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point. (b) Insurance and insurance-related services With respect to Cross-border trade in services – Market access, National treatment: In BG: Transport insurance, covering goods, insurance of vehicles as such and liability insurance regarding risks located in the Bulgaria may not be underwritten by foreign insurance companies directly. In DE: If a foreign insurance company has established a branch in Germany, it may conclude insurance contracts in Germany relating to international transport only through the branch established in Germany. Existing measures: DE: Luftverkehrsgesetz (LuftVG); and Luftverkehrszulassungsordnung (LuftVZO). With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In ES: Residence is required, or alternatively to have two years of experience, for the actuarial profession. With respect to Cross-border trade in services – Local presence: In FI: The supply of insurance broker services is subject to a permanent place of business in the EU. Only insurers having their head office in the European Union or having their branch in Finland may offer direct insurance services, including co-insurance. Existing measures: FI: Laki ulkomaisista vakuutusyhtiöistä (Act on Foreign Insurance Companies) (398/1995); Vakuutusyhtiölaki (Insurance Companies Act) (521/2008); Laki vakuutusten tarjoamisesta (Act on Insurance Distribution) (234/2018). In FR: Insurance of risks relating to ground transport may be underwritten only by insurance firms established in the European Union. Existing measures: FR: Code des assurances. In HU: Only legal persons of the EU and branches registered in Hungary may supply direct insurance services. Existing measures: HU: Act LX of 2003. In IT: Transport insurance of goods, insurance of vehicles and liability insurance regarding risks located in Italy may be underwritten only by insurance companies established in the European Union, except for international transport involving imports into Italy. Cross-border supply of actuarial services. Existing measures: IT: Article 29 of the code of private insurance (Legislative decree no. 209 of 7 September 2005), Law 194/1942 on the actuarial profession. In PT: Air and maritime transport insurance, covering goods, aircraft, hull and liability can be underwritten only by enterprises legal persons of the European Union. Only natural persons of, or enterprises established in, the European Union may act as intermediaries for such insurance business in Portugal. Existing measure: PT: Article 3 of Law 147/2015, Article 8 of Law 7/2019. With respect to Investment liberalisation – Market access, National treatment In SK: Foreign nationals may establish an insurance company in the form of a joint stock company or may conduct insurance business through their branches having a registered office in the Slovak Republic. The authorisation in both cases is subject to the evaluation of the supervisory authority. Existing measures: SK: Act 39/2015 on Insurance. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access In FI: At least one half of the members of the board of directors and the supervisory board, and the managing director of an insurance company providing statutory pension insurance shall have their place of residence in the EEA, unless the competent authorities have granted an exemption. Foreign insurers cannot obtain a licence in Finland as a branch to carry out statutory pension insurance. At least one auditor shall have his permanent residence in the EEA. For other insurance companies, residency in the EEA is required for at least one member of the board of directors, the supervisory board and the managing director. At least one auditor shall have his permanent residence in the EEA. The general agent of an insurance company of the United Kingdom must have his place of residence in Finland, unless the company has its head office in the European Union. Existing measures: FI: Laki ulkomaisista vakuutusyhtiöistä (Act on Foreign Insurance Companies) (398/1995); Vakuutusyhtiölaki (Insurance Companies Act) (521/2008); Laki vakuutusedustuksesta (Act on Insurance Mediation) (570/2005); Laki vakuutusten tarjoamisesta (Act on Insurance Distribution) (234/2018) and Laki työeläkevakuutusyhtiöistä (Act on Companies providing statutory pension insurance) (354/1997). (c) Banking and other Financial Services With respect to Investment liberalisation – Market access and Cross-border trade in services – Local presence: The EU: Only legal persons having their registered office in the Union can act as depositories of the assets of investment funds. The establishment of a specialised management company, having its head office and registered office in the same Member State, is required to perform the activities of management of common funds, including unit trusts, and where allowed under national law, investment companies. Existing measures: EU: Directive 2009/65/EC of the European Parliament and of the Council (2); and Directive 2011/61/EU of the European Parliament and of the Council (3). In EE: For acceptance of deposits, requirement of authorisation by the Estonian Financial Supervision Authority and registration under Estonian law as a joint-stock company, a subsidiary or a branch. Existing measures: EE: Krediidiasutuste seadus (Credit Institutions Act) § 206 and §21. In SK: Investment services can only be provided by management companies which have the legal form of a joint-stock company with equity capital according to the law. Existing measures: SK: Act 566/2001 on Securities and Investment Services; and Act 483/2001 on Banks. With respect to Investment liberalisation –National treatment, Senior management and board of directors In FI: At least one of the founders, the members of the board of directors, the supervisory board, the managing director of banking services providers and the person entitled to sign the name of the credit institution shall have their permanent residence in the EEA. At least one auditor shall have his permanent residence in the EEA. Existing measures: FI: Laki liikepankeista ja muista osakeyhtiömuotoisista luottolaitoksista (Act on Commercial Banks and Other Credit Institutions in the Form of a Limited Company) (1501/2001); Säästöpankkilaki (1502/2001) (Savings Bank Act); Laki osuuspankeista ja muista osuuskuntamuotoisista luottolaitoksista (1504/2001) (Act on Cooperative Banks and Other Credit Institutions in the Form of a Cooperative Bank); Laki hypoteekkiyhdistyksistä (936/1978) (Act on Mortgage Societies); Maksulaitoslaki (297/2010) (Act on Payment Institutions); Laki ulkomaisen maksulaitoksen toiminnasta Suomessa (298/2010) (Act on the Operation of Foreign Payment Institution in Finland); and Laki luottolaitostoiminnasta (Act on Credit Institutions) (121/2007). With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services - Local presence: In IT: Services of "consulenti finanziari" (financial consultant). In providing the activity of door-to-door selling, intermediaries must utilise authorised financial salesmen resident within the territory of a Member State. Existing measures: IT: Articles 91-111 of Consob Regulation on Intermediaries (no. 16190 of 29 October 2007). With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Local presence: In LT: Only banks having their registered office or branch in Lithuania and authorised to provide investment services in the EEA may act as the depositories of the assets of pension funds. At least one head of a bank's administration must speak the Lithuanian language. Existing measures: LT: Law on Banks of the Republic of Lithuania of 30 March 2004 No IX-2085, as amended by the Law No XIII-729 of 16 November 2017; Law on Collective Investment Undertakings of the Republic of Lithuania of 4 July 2003 No IX-1709, as amended by the Law No XIII-1872 of 20 December 2018; Law on Supplementary Voluntary Pension Accumulation of the Republic of Lithuania of 3 June 1999 No VIII-1212 (as revised in Law No XII-70 of 20 December 2012); Law on Payments of the Republic of Lithuania of 5 June 2003 No. IX-1596, last amendment 17 of October 2019 Nr. XIII-2488 Law on Payment Institutions of the Republic of Lithuania of 10 December 2009 No. XI-549 (new version of the Law: No XIII-1093 of 17 April 2018) With respect to Cross-border trade in services – Market access: In FI: For payment services, residency or domicile in Finland may be required. Reservation No. 17 - Health and social services Sector: Health and social services Industry classification: CPC 93, 931, other than 9312, part of 93191, 9311, 93192, 93193, 93199 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Health services – hospital, ambulance, residential health services (CPC 93, 931, other than 9312, part of 93191, 9311, 93192, 93193, 93199) With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of directors: The EU: For the supply of all health services which receive public funding or State support in any form. The EU: For all privately funded health services, other than privately funded hospital, ambulance, and residential health facilities services other than hospital services. The participation of private operators in the privately funded health network may be subject to concession on a non-discriminatory basis. An economic needs test may apply. Main criteria: number of and impact on existing establishments, transport infrastructure, population density, geographic spread, and creation of new employment. This reservation does not relate to the supply of all health-related professional services, including the services supplied by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, and psychologists, which are covered by other reservations (CPC 931 other than 9312, part of 93191). In AT, PL and SI: The supply of privately funded ambulance services (CPC 93192). In BE: the establishment of privately funded ambulance and residential health facilities services other than hospital services (CPC 93192, 93193). In BG, CY, CZ, FI, MT and SK: The supply of privately-funded hospital, ambulance, and residential health services other than hospital services (CPC 9311, 93192, 93193). In FI: Supply of other human health services (CPC 93199). Existing measures: CZ: Act No. 372/2011 Sb. on Health Care Services and Conditions of Their Provision. FI: Laki yksityisestä terveydenhuollosta (Act on Private Health Care) (152/1990). With respect to Investment liberalisation – Market access, National treatment, Most-favoured nation treatment, Senior management and boards of directors, Performance requirements: In DE: The supply of the Social Security System of Germany, where services may be provided by different companies or entities involving competitive elements which are thus not "Services carried out exclusively in the exercise of governmental authority". To accord better treatment in the context of a bilateral trade agreement with regard to the supply of health and social services (CPC 93). With respect to Investment liberalisation – Market access, National treatment: In DE: The ownership of hospitals run by the German Forces. To nationalise other key privately funded hospitals (CPC 93110). In FR: To the supply of privately funded laboratory analysis and testing services. With respect to Cross-border trade in services – Market access, National treatment: In FR: The supply of privately funded laboratory analysis and testing services (part of CPC 9311). Existing measures: FR: Code de la Santé Publique (b) Health and social services, including pension insurance With respect to Cross-border trade in services – Market access, National treatment, Local presence: The EU, with the exception of HU: The cross-border supply of health services, social services and activities or services forming part of a public retirement plan or statutory system of social security. This reservation does not relate to the supply of all health-related professional services, including the services provided by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, and psychologists, which are covered by other reservations (CPC 931 other than 9312, part of 93191). In HU: The cross-border supply of all hospital, ambulance, and residential health services other than hospital services, which receive public funding (CPC 9311, 93192, 93193). (c) Social services, including pension insurance With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements: The EU: The supply of all social services which receive public funding or State support in any form and activities or services forming part of a public retirement plan or statutory system of social security. The participation of private operators in the privately funded social network may be subject to concession on a non-discriminatory basis. An economic needs test may apply. Main criteria: number of and impact on existing establishments, transport infrastructure, population density, geographic spread, and creation of new employment. In BE, CY, DE, DK, EL, ES, FR, IE, IT and PT: The supply of privately funded social services other than services relating to convalescent and rest houses and old people's homes. In CZ, FI, HU, MT, PL, RO, SK, and SI: The supply of privately funded social services. In DE: The Social Security System of Germany, where services are provided by different companies or entities involving competitive elements and might therefore not fall under the definition of the "Services carried out exclusively in the exercise of governmental authority". Existing measures: FI: Laki yksityisistä sosiaalipalveluista (Private Social Services Act) (922/2011). IE: Health Act 2004 (S. 39); and Health Act 1970 (as amended –S.61A). IT: Law 833/1978 Institution of the public health system; Legislative Decree 502/1992 Organisation and discipline of the health field; and Law 328/2000 Reform of social services. Reservation No. 18 - Tourism and travel related services Sector: Tourist guides services, health and social services Industry classification: CPC 7472 Type of reservation: National treatment Most-favoured-nation treatment Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: With respect to Investment liberalisation –National treatment and Cross-border trade in services – National treatment: In FR: To require nationality of a Member State for the supply of tourist guide services. With respect to Investment liberalisation – Most-favoured-nation treatment and Cross-border trade in services – Most-favoured-nation treatment: In LT: In so far as the United Kingdom allows nationals of Lithuania to provide tourist guide services, Lithuania will allow nationals of the United Kingdom to provide tourist guide services under the same conditions. Reservation No. 19 - Recreational, cultural and sporting services Sector: Recreational, cultural and sporting services Industry classification: CPC 962, 963, 9619, 964 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Libraries, archives, museums and other cultural services (CPC963) With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of director, and Cross-border trade in services – Market access, National treatment, Local presence: The EU, with the exception of AT and, for investment liberalisation, in LT: The supply of library, archive, museum and other cultural services. In AT and LT: A licence or concession may be required for establishment. (b) Entertainment services, theatre, live bands and circus services (CPC 9619, 964 other than 96492) With respect to Cross-border trade in services – Market access, National treatment: The EU, with the exception of AT and SE: The cross-border supply of entertainment services, including theatre, live bands, circus and discotheque services. With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of director, and Cross-border trade in services – Market access, National treatment, Local presence: In CY, CZ, FI, MT, PL, RO, SI and SK: With respect to the supply of entertainment services, including theatre, live bands, circus and discotheque services. In BG: The supply of the following entertainment services: circus, amusement park and similar attraction services, ballroom, discotheque and dance instructor services, and other entertainment services. In EE: The supply of other entertainment services except for cinema theatre services. In LT and LV: The supply of all entertainment services other than cinema theatre operation services. In CY, CZ, LV, PL, RO and SK: The cross-border supply of sporting and other recreational services. (c) News and press agencies (CPC 962) With respect to Investment liberalisation – Market access, National treatment: In FR: Foreign participation in existing companies publishing publications in the French language may not exceed 20 per cent of the capital or of voting rights in the company. The establishment of press agencies of the United Kingdom is subject to conditions set out in domestic regulation. The establishment of press agencies by foreign investors is subject to reciprocity. Existing measures: FR: Ordonnance n° 45-2646 du 2 novembre 1945 portant règlementation provisoire des agences de presse; and Loi n° 86-897 du 1 août 1986 portant réforme du régime juridique de la presse. With respect to Cross-border trade in services – Market access: In HU: For supply of news and press agencies services. (d) Gambling and betting services (CPC 96492) With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of director, and Cross-border trade in services – Market access, National treatment, Local presence: The EU: The supply of gambling activities, which involve wagering a stake with pecuniary value in games of chance, including in particular lotteries, scratch cards, gambling services offered in casinos, gambling arcades or licensed premises, betting services, bingo services and gambling services operated by and for the benefit of charities or non-profit-making organisations. Reservation No. 20 - Transport services and auxiliary transport services Sector: Transport services Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Maritime transport – any other commercial activity undertaken from a ship With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services – Market access, National treatment: The EU: The nationality of the crew on a seagoing or non-seagoing vessel. With respect to Investment liberalisation – Market access, National treatment, Most-favoured nation treatment, Senior management and boards of directors: The EU, except LV and MT: Only EU natural or legal persons may register a vessel and operate a fleet under the national flag of the state of establishment (applies to all commercial marine activity undertaken from a seagoing ship, including fishing, aquaculture, and services incidental to fishing; international passenger and freight transportation (CPC 721); and services auxiliary to maritime transport). With respect to Investment liberalisation – Market access and Cross-border trade in services – Market access: In MT: Exclusive rights exist for the maritime link to mainland Europe through Italy with Malta (CPC 7213, 7214, part of 742, 745, part of 749). With respect to Cross-border trade in services – Market access, National treatment, Local presence: In SK: Foreign investors must have their principal office in the Slovak Republic in order to apply for a licence enabling them to provide a service (CPC 722). (b) Auxiliary services to maritime transport With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access, National treatment, Local presence: The EU: The supply of pilotage and berthing services. For greater certainty, regardless of the criteria which may apply to the registration of ships in a Member State of the European Union, the European Union reserves the right to require that only ships registered on the national registers of Member States of the European Union may provide pilotage and berthing services (CPC 7452). The EU, with the exception of LT and LV: Only vessels carrying the flag of a Member State of the European Union may provide pushing and towing services (CPC 7214). With respect to Investment liberalisation – Market access and Cross-border trade in services –National treatment, Local presence: In LT: Only juridical persons of Lithuania or juridical persons of a Member State of the European Union with branches in Lithuania that have a Certificate issued by the Lithuanian Maritime Safety Administration may provide pilotage and berthing, pushing and towing services (CPC 7214, 7452). With respect to Investment liberalisation – Market access and Cross-border trade in services – Market access, National treatment, Local presence: In BE: Cargo handling services can only be operated by accredited workers, eligible to work in port areas designated by royal decree (CPC 741). Existing measures: BE: Loi du 8 juin 1972 organisant le travail portuaire; Arrêté royal du 12 janvier 1973 instituant une Commission paritaire des ports et fixant sa dénomination et sa compétence; Arrêté royal du 4 septembre 1985 portant agrément d'une organisation d'employeur (Anvers); Arrêté royal du 29 janvier 1986 portant agrément d'une organisation d'employeur (Gand); Arrêté royal du 10 juillet 1986 portant agrément d'une organisation d'employeur (Zeebrugge); Arrêté royal du 1er mars 1989 portant agrément d'une organisation d'employeur (Ostende); and Arrêté royal du 5 juillet 2004 relatif à la reconnaissance des ouvriers portuaires dans les zones portuaires tombant dans le champ d'application de la loi du 8 juin 1972 organisant le travail portuaire, tel que modifié. (c) Auxiliary services to inland waterways transport With respect to Investment liberalisation – Market access, National treatment, Most-favoured nation treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services – Market access, National treatment, Local presence, Most favoured-nation treatment: The EU: Services auxiliary to inland waterways transportation. (d) Rail transport and auxiliary services to rail transport With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment, Local presence: In EU: Railway passenger transportation (CPC 7111). With respect to Investment liberalisation – Market access, and Cross-border trade in services – Market access, Local Presence: In EU: Railway freight transportation (CPC 7112). In LT: Maintenance and repair services of rail transport equipment are subject to a state monopoly (CPC 86764, 86769, part of 8868). In SE (with respect only to Market access): Maintenance and repair services of rail transport equipment are subject to an economic needs test when an investor intends to establish its own terminal infrastructure facilities. Main criteria: space and capacity constraints (CPC 86764, 86769, part of 8868). Existing measures: EU: Directive 2012/34/EU of the European Parliament and of the Council (4). SE: Planning and Building Act (2010:900). (e) Road transport (passenger transportation, freight transportation, international truck transport services) and services auxiliary to road transport With respect to Cross-border trade in services – Market access, National treatment, Local presence: The EU: For road transport services covered by Heading Three of Part Two of this Agreement and Annex 31 to this Agreement. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors: The EU: For road transport services covered by Heading Three of Part Two of this Agreement and Annex 31 to this Agreement: To limit the supply of cabotage within a Member State by foreign investors established in another Member State (CPC 712). With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access, National treatment, Local presence: The EU: For road transport services not covered by Heading Three of Part Two of this Agreement and Annex 31 to this Agreement: (i) to require establishment and to limit the cross-border supply of road transport services (CPC 712). (ii) to limit the supply of cabotage within a Member State by foreign investors established in another Member State (CPC 712). (iii) an economic needs test may apply to taxi services in the Union setting a limit on the number of service suppliers. Main criteria: local demand as provided in applicable laws (CPC 71221). With respect to Investment liberalisation – Market access: In BE: A maximum number of licences can be fixed by law (CPC 71221). In IT: An economic needs test is applied to limousine services. Main criteria: number of and impact on existing establishments, population density, geographical spread, impact on traffic conditions and creation of new employment. An economic needs test is applied to intercity bussing services. Main criteria: number of and impact on existing establishments, population density, geographical spread, impact on traffic conditions and creation of new employment. An economic needs test is applied to the supply of freight transportation services. Main criteria: local demand (CPC 712). In BG, DE: For passenger and freight transportation, exclusive rights or authorisations may only be granted to natural persons of the Union and to legal persons of the Union having their headquarters in the Union. (CPC 712). In MT: For public bus service: The entire network is subject to a concession which includes a Public Service Obligation agreement to cater for certain social sectors (such as students and the elderly) (CPC 712). With respect to Investment liberalisation – Market access, National treatment, In FI: Authorisation is required to provide road transport services, which is not extended to foreign registered vehicles (CPC 712). With respect to Investment liberalisation – Market access, National treatment: In FR: The supply of intercity bussing services (CPC 712). With respect to Investment liberalisation – Market access: In ES: For passenger transportation, an economic needs test applies to services provided under CPC 7122. Main criteria: local demand. An economic needs test applies for intercity bussing services. Main criteria: number of and impact on existing establishments, population density, geographical spread, impact on traffic conditions and creation of new employment. In SE: Maintenance and repair services of road transport equipment are subject to an economic needs test when a supplier intends to establish its own terminal infrastructure facilities. Main criteria: space and capacity constraints (CPC 6112, 6122, 86764, 86769, part of 8867). In SK: For freight transportation, an economic needs test is applied. Main criteria: local demand (CPC 712). With respect to Cross-border trade in services – Market access: In BG: To require establishment for supporting services to road transport (CPC 744). Existing measures: EU: Regulation (EC) No 1071/2009 of the European Parliament and of the Council (5); Regulation (EC) No 1072/2009 of the European Parliament and of the Council (6); and Regulation (EC) No 1073/2009 of the European Parliament and of the Council (7). FI: Laki kaupallisista tavarankuljetuksista tiellä (Act on Commercial Road Transport) 693/2006; Laki liikenteen palveluista (Act on Transport Services) 320/2017; Ajoneuvolaki (Vehicles Act) 1090/2002. IT: Legislative decree 285/1992 (Road Code and subsequent amendments) article 85; Legislative Decree 395/2000 article 8 (road transport of passengers); Law 21/1992 (Framework law on non-scheduled public road transport of passengers); Law 218/2003 article 1 (transport of passenger through rented buses with driver); and Law 151/1981 (framework law on public local transport). SE: Planning and Building Act (2010:900). (f) Space transport and rental of space craft With respect to Investment liberalisation – Market access, National treatment, Performance requirements, Senior management and boards of directors and Cross-border trade in services – Market access, National treatment, Local presence: The EU: The supply of space transport services and the supply of rental of space craft services (CPC 733, part of 734). (g) Most-favoured-nation exemptions With respect to Investment liberalisation – Most-favoured-nation treatment, and Cross-border trade in services – Most-favoured-nation treatment: — Transport (cabotage) other than maritime transport In FI: According differential treatment to a country pursuant to existing or future bilateral agreements exempting vessels registered under the foreign flag of a specified other country or foreign registered vehicles from the general prohibition from providing cabotage transport (including combined transport, road and rail) in Finland on the basis of reciprocity (part of CPC 711, part of 712, part of 722). — Supporting services for maritime transport In BG: In so far as the United Kingdom allows service suppliers from Bulgaria to supply cargo-handling services and storage and warehouse services in sea and river harbours, including services relating to containers and goods in containers, Bulgaria will allow service suppliers from the United Kingdom to supply cargo-handling services and storage and warehouse services in sea and river harbours, including services relating to containers and goods in containers under the same conditions (part of CPC 741, part of 742). — Rental or leasing of vessels In DE: Chartering-in of foreign ships by consumers resident in Germany may be subject to a condition of reciprocity (CPC 7213, 7223, 83103). — Road and rail transport The EU: To accord differential treatment to a country pursuant to existing or future bilateral agreements relating to international road haulage (including combined transport – road or rail) and passenger transport, concluded between the Union or the Member States and a third country (CPC 7111, 7112, 7121, 7122, 7123). That treatment may: (a) reserve or limit the supply of the relevant transport services between the contracting Parties or across the territory of the contracting Parties to vehicles registered in each contracting Party (8); or (b) provide for tax exemptions for such vehicles. — Road transport In BG: Measures taken under existing or future agreements, which reserve or restrict the supply of these kinds of transportation services and specify the terms and conditions of this supply, including transit permits or preferential road taxes, in the territory of Bulgaria or across the borders of Bulgaria (CPC 7121, 7122, 7123). In CZ: Measures that are taken under existing or future agreements, and which reserve or limit the supply of transport services and specify operating conditions, including transit permits or preferential road taxes of a transport services into, in, across and out of the Czech Republic to the contracting parties concerned (CPC 7121, 7122, 7123). In ES: Authorisation for the establishment of a commercial presence in Spain may be refused to service suppliers whose country of origin does not accord effective market access to service suppliers of Spain (CPC 7123). Existing measures: Ley 16/1987, de 30 de julio, de Ordenación de los Transportes Terrestres. In HR: Measures applied under existing or future agreements on international road transport and which reserve or limit the supply of transport services and specify operating conditions, including transit permits or preferential road taxes of transport services into, in, across and out of Croatia to the parties concerned (CPC 7121, 7122, 7123). In LT: Measures that are taken under bilateral agreements and which set the provisions for transport services and specify operating conditions, including bilateral transit and other transport permits for transport services into, through and out of the territory of Lithuania to the contracting parties concerned, and road taxes and levies (CPC 7121, 7122, 7123). In SK: Measures that are taken under existing or future agreements, and which reserve or limit the supply of transport services and specify operating conditions, including transit permits or preferential road taxes of a transport services into, in, across and out of the Slovak Republic to the contracting parties concerned (CPC 7121, 7122, 7123). — Rail transport In BG, CZ and SK: For existing or future agreements, and which regulate traffic rights and operating conditions, and the supply of transport services in the territory of Bulgaria, the Czech Republic and Slovakia and between the countries concerned. (CPC 7111, 7112). — Air transport - Services auxiliary to air transport The EU: According differential treatment to a third country pursuant to existing or future bilateral agreements relating to ground-handling services. — Road and rail transport In EE: when according differential treatment to a country pursuant to existing or future bilateral agreements on international road transport (including combined transport-road or rail), reserving or limiting the supply of a transport services into, in, across and out of Estonia to the contracting Parties to vehicles registered in each contracting Party, and providing for tax exemption for such vehicles (part of CPC 711, part of 712, part of 721). — All passenger and freight transport services other than maritime and air transport In PL: In so far as the United Kingdom allows the supply of transport services into and across the territory of the United Kingdom by passenger and freight transport suppliers of Poland, Poland will allow the supply of transport services by passenger and freight transport suppliers of the United Kingdom into and across the territory of Poland under the same conditions. Reservation No. 21 - Agriculture, fishing and water Sector: Agriculture, hunting, forestry; fishing, aquaculture, services incidental to fishing; collection, purification and distribution of water Industry classification: ISIC Rev. 3.1 011, ISIC Rev. 3.1 012, ISIC Rev. 3.1 013, ISIC Rev. 3.1 014, ISIC Rev. 3.1 015, CPC 8811, 8812, 8813 other than advisory and consultancy services; ISIC Rev. 3.1 0501, 0502, CPC 882 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Agriculture, hunting and forestry With respect to Investment liberalisation – Market access, National treatment: In HR: Agricultural and hunting activities. In HU: Agricultural activities (ISIC Rev. 3.1 011, 3.1 012, 3.1 013, 3.1 014, 3.1 015, CPC 8811, 8812, 8813 other than advisory and consultancy services). Existing measures: HR: Agricultural Land Act (OG 20/18, 115/18, 98/19) (b) Fishing, aquaculture and services incidental to fishing (ISIC Rev. 3.1 0501, 0502, CPC 882) With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements, Most-favoured-nation treatment and Cross-border trade in services – Market access, National treatment, Most-favoured-nation treatment, Local presence: The EU: 1. In particular within the framework of the Common Fisheries Policy, and of fishing agreements with a third country, access to and use of the biological resources and fishing grounds situated in maritime waters coming under the sovereignty or the jurisdiction of Member States, or entitlements for fishing under a Member State fishing licence, including: (a) regulating the landing of catches by vessels flying the flag of the United Kingdom or a third country with respect to the quotas allocated to them or, only with respect to vessels flying the flag of a Member State, requiring that a proportion of the total catch is landed in Union ports; (b) determining a minimum size for a company in order to preserve both artisanal and coastal fishing vessels; (c) according differential treatment pursuant to existing or future bilateral agreements relating to fisheries; and (d) requiring the crew of a vessel flying the flag of a Member State to be nationals of Member States. 2. A fishing vessel’s entitlement to fly the flag of a Member State only if: (a) it is wholly owned by: (i) companies incorporated in the Union; or (ii) Member State nationals; (b) its day-to-day operations are directed and controlled from within the Union; and (c) any charterer, manager or operator of the vessel is a company incorporated in the Union or a national of a Member State. 3. A commercial fishing licence granting the right to fish in the territorial waters of a Member State may only be granted to vessels flying the flag of a Member State. 4. The establishment of marine or inland aquaculture facilities. 5. Point (a), (b), (c) (other than with respect to most-favoured nation treatment) and (d) of paragraph 1; point (a)(i), point (b) and (c) of paragraph 2 and paragraph 3 only apply to measures which are applicable to vessels or to enterprises irrespective of the nationality of their beneficial owners. With respect to Investment liberalisation – Market access: In FR: Nationals of non-European Union countries cannot participate in French maritime State property for fish, shellfish or algae farming. With respect to Investment liberalisation – Market access, National treatment, Most-favoured nation treatment and Cross-border trade in services – Market access, National treatment: In BG: The taking of marine and river-living resources, performed by vessels in the internal marine waters, and the territorial sea of Bulgaria, shall be performed by vessels flying the flag of Bulgaria. A foreign ship may not engage in commercial fishing in the exclusive economic zone save on the basis of an agreement between Bulgaria and the flag state. While passing through the exclusive economic zone, foreign fishing ships may not maintain their fishing gear in operational mode. (c) Collection, purification and distribution of water With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment, Local presence: The EU: For activities, including services relating to the collection, purification and distribution of water to household, industrial, commercial or other users, including the supply of drinking water, and water management. Reservation No. 22 - Energy related activities Sector: Production of energy and related services Industry classification: ISIC Rev. 3.1 10, 1110, 12, 120, 1200, 13, 14, 232, 233, 2330, 40, 401, 4010, 402, 4020, part of 4030, CPC 613, 62271, 63297, 7131, 71310, 742, 7422, part of 88, 887. Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Energy services – general (ISIC Rev. 3.1 10, 1110, 13, 14, 232, 40, 401, 402, part of 403, 41; CPC 613, 62271, 63297, 7131, 742, 7422, 887 (other than advisory and consulting services)) With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services – Market access, National treatment, Local presence: The EU: Where a Member State permits foreign ownership of a gas or electricity transmission system, or an oil and gas pipeline transport system, with respect to enterprises of the United Kingdom controlled by natural or legal persons of a third country which accounts for more than 5 per cent of the Union's oil, natural gas or electricity imports, in order to guarantee the security of the energy supply of the Union as a whole, or of an individual Member State. This reservation does not apply to advisory and consultancy services provided as services incidental to energy distribution. This reservation does not apply to HR, HU and LT (for LT, only CPC 7131) with regard to the pipeline transport of fuels, nor to LV with regard to services incidental to energy distribution, nor to SI with regard to services incidental to the distribution of gas (ISIC Rev. 3.1 401, 402, CPC 7131, 887 other than advisory and consultancy services). In CY: For the manufacture of refined petroleum products in so far as the investor is controlled by a natural or juridical person of a third country which accounts for more than 5 per cent of the Union's oil or natural gas imports, as well as to the manufacture of gas, distribution of gaseous fuels through mains on own account, the production, transmission and distribution of electricity, the pipeline transportation of fuels, services incidental to electricity and natural gas distribution other than advisory and consulting services, wholesale services of electricity, retailing services of motor fuel, electricity and non-bottled gas. Nationality and residency conditions applies for electricity related services. (ISIC Rev. 3.1 232, 4010, 4020, CPC 613, 62271, 63297, 7131, and 887 other than advisory and consulting services). In FI: The transmission and distribution networks and systems of energy and of steam and hot water. In FI: The quantitative restrictions in the form of monopolies or exclusive rights for the importation of natural gas, and for the production and distribution of steam and hot water. Currently, natural monopolies and exclusive rights exist (ISIC Rev. 3.1 40, CPC 7131, 887 other than advisory and consultancy services). In FR: The electricity and gas transmission systems and oil and gas pipeline transport (CPC 7131). With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access, National treatment, Local presence: In BE: The energy distribution services, and services incidental to energy distribution (CPC 887 other than consultancy services). With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services –National treatment, Local presence: In BE: For energy transmission services, regarding the types of legal entities and to the treatment of public or private operators to whom BE has conferred exclusive rights. Establishment is required within the Union (ISIC Rev. 3.1 4010, CPC 71310). In BG: For services incidental to energy distribution (part of CPC 88). In PT: For the production, transmission and distribution of electricity, the manufacturing of gas, the pipeline transportation of fuels, wholesale services of electricity, retailing services of electricity and non-bottled gas, and services incidental to electricity and natural gas distribution. Concessions for electricity and gas sectors are assigned only to limited companies with their headquarters and effective management in PT (ISIC Rev. 3.1 232, 4010, 4020, CPC 7131, 7422, 887 other than advisory and consulting services). In SK: An authorisation is required for the production, transmission and distribution of electricity, manufacture of gas and distribution of gaseous fuels, production and distribution of steam and hot water, pipeline transportation of fuels, wholesale and retail of electricity, steam and hot water, and services incidental to energy distribution, including services in the area of energy efficiency, energy savings and energy audit. An economic needs test is applied and the application may be denied only if the market is saturated. For all those activities, an authorisation may only be granted to a natural person with permanent residency in the EEA or a legal person of the EEA. With respect to Investment liberalisation – Market access, National treatment: In BE: With the exception of the mining of metal ores and other mining and quarrying, enterprises controlled by natural or legal persons of a third country which accounts for more than 5 per cent of the European Union's oil or natural gas or electricity imports may be prohibited from obtaining control of the activity. Incorporation is required (no branching) (ISIC Rev. 3.1 10, 1110, 13, 14, 232, part of 4010, part of 4020, part of 4030). Existing measures: EU: Directive (EU) 2019/944 of the European Parliament and of the Council (9); and Directive 2009/73/EC of the European Parliament and of the Council (10). BG: Energy Act. CY: The Regulation of the Electricity Market Laws of 2003 Law 122(I)/2003 as amended; The Regulation of the Gas Market Laws of 2004, Law 183(I)/2004 as amended; The Petroleum (Pipelines) Law, Chapter 273; The Petroleum Law Chapter 272 as amended; and The Petroleum and Fuel Specifications Laws of 2003, Law 148(I)/2003 as amended. FI: Maakaasumarkkinalaki (Natural Gas Market Act) (508/2000); and Sähkömarkkinalaki (Electricity Market Act) (386/1995). Maakaasumarkkinalaki (Natural Gas Market Act) (587/2017) FR: Code de l'énergie. PT: Decree-Law 230/2012 and Decree-Law 231/2012, 26 October - Natural Gas; Decree-Law 215-A/2012, and Decree-Law 215-B/2012, 8 October – Electricity; and Decree-Law 31/2006, 15 February – Crude oil/Petroleum products. SK: Act 51/1988 on Mining, Explosives and State Mining Administration; Act 569/2007 on Geological Works; Act 251/2012 on Energy; and Act 657/2004 on Thermal Energy. (b) Electricity (ISIC Rev. 3.1 40, 401; CPC 62271, 887 (other than advisory and consulting services)) With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services – Market access, National treatment: In FI: The importation of electricity. With respect to cross-border trade, the wholesale and retail of electricity. In FR: Only companies where 100 per cent of the capital is held by the French State, by another public sector organisation or by Electricité de France (EDF), may own and operate electricity transmission or distribution systems. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In BG: For the production of electricity and the production of heat. In PT: The activities of electricity transmission and distribution are carried out through exclusive concessions of public service. With respect to Investment liberalisation – Market access, National treatment: In BE: An individual authorisation for the production of electricity of a capacity of 25 MW or above requires establishment in the Union, or in another State which has a regime similar to that enforced by Directive 96/92/EC of the European Parliament and of the Council (11) in place, and where the company has an effective and continuous link with the economy. The production of electricity within the offshore territory of BE is subject to concession and a joint venture obligation with a legal person of the Union, or with a legal person of a country having a regime similar to that of Directive 2003/54/EC of the European Parliament and of the Council (12), particularly with regard to conditions relating to the authorisation and selection. Additionally, the legal person should have its central administration or its head office in a Member State of the European Union or a country meeting the above criteria, where it has an effective and continuous link with the economy. The construction of electrical power lines which link offshore production to the transmission network of Elia requires authorisation and the company must meet the previously specified conditions, except for the joint venture requirement. With respect to Cross-border trade in services – National treatment: In BE: An authorisation is necessary for the supply of electricity by an intermediary having customers established in BE who are connected to the national grid system or to a direct line whose nominal voltage is higher than 70,000 volts. That authorisation may only be granted to a natural or legal person of the EEA. With respect to Investment liberalisation – Market access: In FR: For the production of electricity. Existing measures: BE: Arrêté Royal du 11 octobre 2000 fixant les critères et la procédure d'octroi des autorisations individuelles préalables à la construction de lignes directes; Arrêté Royal du 20 décembre 2000 relatif aux conditions et à la procédure d'octroi des concessions domaniales pour la construction et l'exploitation d'installations de production d'électricité à partir de l'eau, des courants ou des vents, dans les espaces marins sur lesquels la Belgique peut exercer sa juridiction conformément au droit international de la mer; and Arrêté Royal du 12 mars 2002 relatif aux modalités de pose de câbles d'énergie électrique qui pénètrent dans la mer territoriale ou dans le territoire national ou qui sont installés ou utilisés dans le cadre de l'exploration du plateau continental, de l'exploitation des ressources minérales et autres ressources non vivantes ou de l'exploitation d'îles artificielles, d'installations ou d'ouvrages relevant de la juridiction belge. Arrêté royal relatif aux autorisations de fourniture d'électricité par des intermédiaires et aux règles de conduite applicables à ceux-ci. Arrêté royal du 12 juin 2001 relatif aux conditions générales de fourniture de gaz naturel et aux conditions d'octroi des autorisations de fourniture de gaz naturel. FI: Maakaasumarkkinalaki (Natural Gas Market Act) (508/2000); and Sähkömarkkinalak (Electricity Market Act) 588/2013; Maakaasumarkkinalaki (Natural Gas Market Act) (587/2017) FR: Code de l'énergie. PT: Decree-Law 215-A/2012; and Decree-Law 215-B/2012, 8 October – Electricity. (c) Fuels, gas, crude oil or petroleum products (ISIC Rev. 3.1 232, 40, 402; CPC 613, 62271, 63297, 7131, 71310, 742, 7422, part of 88, 887 (other than advisory and consulting services)) With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services – Market access, National treatment: In FI: To prevent control or ownership of a liquefied natural gas (LNG) terminal (including those parts of the LNG terminal used for storage or re-gasification of LNG) by foreign natural or legal persons for energy security reasons. In FR: Only companies where 100 per cent of the capital is held by the French State, by another public sector organisation or by ENGIE, may own and operate gas transmission or distribution systems for reasons of national energy security. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In BE: For bulk storage services of gas, regarding the types of legal entities and the treatment of public or private operators to whom Belgium has conferred exclusive rights. Establishment is required within the Union for bulk storage services of gas (part of CPC 742). In BG: For pipeline transportation, storage and warehousing of petroleum and natural gas, including transit transmission (CPC 71310, part of CPC 742). In PT: For the cross-border supply of storage and warehousing services of fuels transported through pipelines (natural gas). Also, concessions relating to the transmission, distribution and underground storage of natural gas and the reception, storage and regasification terminal of LNG are awarded through contracts concession, following public calls for tenders (CPC 7131, CPC 7422). With respect to Cross-border trade in services – Market access, National treatment: In BE: The pipeline transport of natural gas and other fuels is subject to an authorisation requirement. An authorisation may only be granted to a natural or juridical person established in a Member State (in accordance with Article 3 of the AR of 14 May 2002). Where the authorisation is requested by a company: (a) the company must be established in accordance with Belgian law, or the law of another Member State, or the law of a third country, which has undertaken commitments to maintain a regulatory framework similar to the common requirements specified in Directive 98/30/EC of the European Parliament and the Council (13); and (b) the company must hold its administrative seat, its principal establishment or its head office within a Member State, or a third country, which has undertaken commitments to maintain a regulatory framework similar to the common requirements specified in Directive 98/30/EC, provided that the activity of this establishment or head office represents an effective and continuous link with the economy of the country concerned (CPC 7131). In BE: In general the supply of natural gas to customers (customers being both distribution companies and consumers whose overall combined consumption of gas arising from all points of supply attains a minimum level of one million cubic metres per year) established in Belgium is subject to an individual authorisation provided by the minister, except where the supplier is a distribution company using its own distribution network. Such an authorisation may only be granted to natural or legal persons of the European Union. In CY: For the cross-border supply of storage and warehousing services of fuels transported through pipelines, and the retail sales of fuel oil and bottled gas other than by mail order (CPC 613, CPC 62271, CPC 63297, CPC 7131, CPC 742). With respect to Investment liberalisation – Market access and Cross-border trade in services – Market access: In HU: The supply of pipeline transport services requires establishment. Services may be provided through a Contract of Concession granted by the state or the local authority. The supply of this service is regulated by the Hungarian Concession Law (CPC 7131). With respect to Cross-border trade in services – Market access: In LT: For pipeline transportation of fuels and services auxiliary to pipeline transport of goods other than fuel. Existing measures: BE: Arrêté Royal du 14 mai 2002 relatif à l'autorisation de transport de produits gazeux et autres par canalisations; and Loi du 12 avril 1965 relative au transport de produits gazeux et autres par canalisations (article 8.2). BG: Energy Act. CY: The Regulation of the Electricity Market Law of 2003, Law 122(I)/2003 as amended; The Regulating of the Gas Market Laws of 2004, Law 183(I)/2004 as amended; The Petroleum (Pipelines) Law, Chapter 273; The Petroleum Law Chapter 272 as amended; and The Petroleum and Fuel Specifications Laws of 2003, Law 148(I)/2003 as amended. FI: Maakaasumarkkinalaki (Natural Gas Market Act) (508/2000); and Maakaasumarkkinalaki (Natural Gas Market Act) (587/2017). FR: Code de l'énergie. HU: Act XVI of 1991 about Concessions. LT: Law on Natural Gas of the Republic of Lithuania of 10 October 2000 No VIII-1973. PT: Decree-Law 230/2012 and Decree-Law 231/2012, 26 October - Natural Gas; Decree-Law 215-A/2012, and Decree-Law 215-B/2012, 8 October – Electricity; and Decree-Law 31/2006, 15 February – Crude oil/Petroleum products. (d) Nuclear (ISIC Rev. 3.1 12, 3.1 23, 120, 1200, 233, 2330, 40, part of 4010, CPC 887)) With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access, National treatment: In DE: For the production, processing or transportation of nuclear material and generation or distribution of nuclear-based energy. With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, National treatment: In AT and FI: for the production, processing distribution or transportation of nuclear material and generation or distribution of nuclear-based energy. In BE: For the production, processing or transportation of nuclear material and generation or distribution of nuclear-based energy. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements: In HU and SE: For the processing of nuclear fuel and nuclear-based electricity generation. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors: In BG: For the processing of fissionable and fusionable materials or the materials from which they are derived, as well as to the trade therewith, to the maintenance and repair of equipment and systems in nuclear energy production facilities, to the transportation of those materials and the refuse and waste matter of their processing, to the use of ionising radiation, and on all other services relating to the use of nuclear energy for peaceful purposes (including engineering and consulting services and services relating to software etc.). With respect to Investment liberalisation – Market access, National treatment: In FR: These activities must respect the obligations of an Euratom Agreement. Existing measures: AT: Bundesverfassungsgesetz für ein atomfreies Österreich (Constitutional Act for a Non-nuclear Austria) BGBl. I Nr. 149/1999. BG: Safe Use of Nuclear Energy Act. FI: Ydinenergialaki (Nuclear Energy Act) (990/1987). HU: Act CXVI of 1996 on Nuclear Energy; and Government Decree Nr. 72/2000 on Nuclear Energy. SE: The Swedish Environmental Code (1998:808); and Law on Nuclear Technology Activities (1984:3). Reservation No. 23 - Other services not included elsewhere Sector: Other services not included elsewhere Industry classification: CPC 9703, part of CPC 612, part of CPC 621, part of CPC 625, part of 85990 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The EU reserves the right to adopt or maintain any measure with respect to the following: (a) Funeral, cremation services and undertaking services (CPC 9703) With respect to Investment liberalisation – Market access, National treatment: In FI: Cremation services and operation/maintenance of cemeteries and graveyards can only be performed by the state, municipalities, parishes, religious communities or non-profit foundations or societies. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access, National treatment, Local presence: In DE: Only legal persons established under public law may operate a cemetery. The creation and operation of cemeteries and services related to funerals. In PT: Commercial presence is required to provide funeral and undertaking services. EEA nationality is required in order to become a technical manager for entities providing funeral and undertaking services. In SE: Church of Sweden or local authority monopoly on cremation and funeral services. In CY, SI: Funeral, cremation and undertaking services. Existing measures: FI: Hautaustoimilaki (Act on Burial Service) (457/2003). PT: Decree-Law 10/2015, of 16 January alterado p/ Lei 15/2018, 27 março. SE: Begravningslag (1990:1144) (Act of Burials); Begravningsförordningen (1990:1147) (Ordinance of Burials). (b) Other business-related services With respect to Cross-border trade in services – Market access: In FI: Require establishment in Finland or elsewhere in the EEA in order to provide electronic identification services. Existing measures: FI: Laki vahvasta sähköisestä tunnistamisesta ja sähköisistä luottamuspalveluista 617/2009 (Act on Strong Electronic Identification and Electronic Trust Services 617/2009). (c) New services With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services – Market access, National treatment, Local presence: The EU: For the provision of new services other than those classified in the United Nations Provisional Central Product Classification (CPC), 1991. Schedule of the United Kingdom Reservation No. 1 – All sectors Reservation No. 2 – Professional services (all professions except health related) Reservation No. 3 – Professional services (health related and retail of pharmaceuticals) Reservation No. 4 – Business services (collection agency services and credit reporting services) Reservation No. 5 – Business services (placement services) Reservation No. 6 – Business services (investigation services) Reservation No. 7 – Business services (other business services) Reservation No. 8 – Education services Reservation No. 9 – Financial services Reservation No. 10 – Health and social services Reservation No. 11 – Recreational, cultural and sporting services Reservation No. 12 – Transport services and auxiliary transport services Reservation No. 13 – Fishing and water Reservation No. 14 – Energy related activities Reservation No. 15 – Other services not included elsewhere Reservation No. 1 – All sectors Sector: All sectors Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Obligations for Legal Services Chapter/ Section: Investment liberalisation, Cross-border trade in services and Regulatory framework for legal services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Commercial presence With respect to Investment liberalisation – Market access: Services considered as public utilities at a national or local level may be subject to public monopolies or to exclusive rights granted to private operators. Public utilities exist in sectors such as related scientific and technical consulting services, research and development (R&D) services on social sciences and humanities, technical testing and analysis services, environmental services, health services, transport services and services auxiliary to all modes of transport. Exclusive rights on such services are often granted to private operators, for instance operators with concessions from public authorities, subject to specific service obligations. Given that public utilities often also exist at the sub-central level, detailed and exhaustive sector-specific scheduling is not practical. This reservation does not apply to telecommunications and to computer and related services. (b) Most-favoured-nation treatment With respect to Investment liberalisation – Most favoured nation treatment and Cross-Border Trade in Services – Most favoured nation treatment and Regulatory Framework for Legal Services – Obligations: According differential treatment pursuant to any international investment treaties or other trade agreement in force or signed prior to entry into force of this Agreement. According differential treatment to a country pursuant to any existing or future bilateral or multilateral agreement which: (i) creates an internal market in services and investment; (ii) grants the right of establishment; or (iii) requires the approximation of legislation in one or more economic sectors. An internal market on services and establishment means an area without internal frontiers in which the free movement of services, capital and persons is ensured. The right of establishment means an obligation to abolish in substance all barriers to establishment among the parties to the regional economic integration agreement by the entry into force of that agreement. The right of establishment shall include the right of nationals of the parties to the regional economic integration agreement to set up and operate enterprises under the same conditions provided for nationals under the law of the country where such establishment takes place. The approximation of legislation means: (i) the alignment of the legislation of one or more of the parties to the regional economic integration agreement with the legislation of the other party or parties to that agreement; or (ii) the incorporation of common legislation into the law of the parties to the regional economic integration agreement. Such alignment or incorporation shall take place, and shall be deemed to have taken place, only at such time that it has been enacted in the law of the party or parties to the regional economic integration agreement. According differential treatment relating to the right of establishment to nationals or enterprises through existing or future bilateral agreements between the UK and any of the following countries or principalities: Andorra, Monaco, San Marino and the Vatican City State. (c) Arms, ammunitions and war material With respect to Investment liberalisation – Market access, National treatment, Most favoured nation treatment, Senior management and boards of directors, Performance requirements and Cross-Border Trade in Services – Market access, Local presence, National treatment, Most favoured nation treatment: Production or distribution of, or trade in, arms, munitions and war material. War material is limited to any product which is solely intended and made for military use in connection with the conduct of war or defence activities. Reservation No. 2 – Professional services (all professions except health related) Sector– sub-sector: Professional services - legal services, auditing services Industry classification: Part of CPC 861, part of 87902, part of 862 Type of reservation: Market access National treatment Senior management and boards of directors Local presence Obligations for Legal Services Chapter/ Section: Investment liberalisation, Cross-border trade in services and Regulatory framework for legal services Description: (a) Legal services With respect to Investment liberalisation – Market access, Senior management and boards of directors, National treatment, Cross-border trade in services – Market access, Local presence, National treatment and Regulatory framework – for legal services – Obligations: The UK reserves the right to adopt or maintain any measure with respect to the supply of legal advisory and legal authorisation, documentation, and certification services provided by legal professionals entrusted with public functions, such as notaries, and with respect to services provided by bailiffs (part of CPC 861, part of 87902). (b) Auditing services (CPC 86211, 86212 other than accounting and bookkeeping services) With respect to Cross-border trade in services – Market access, Local presence, National treatment: The UK reserves the right to adopt or maintain any measure with respect to the cross-border supply of auditing services. Existing measures: Companies Act 2006 Reservation No. 3 - Professional services (health related and retail of pharmaceuticals) Sector: Health related professional services and retail sales of pharmaceutical, medical and orthopaedic goods, other services provided by pharmacists Industry classification: CPC 63211, 85201, 9312, 9319, 93121 Type of reservation: Market access National treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Medical and dental services; services provided by midwives, nurses, physiotherapists, psychologists and paramedical personnel (CPC 63211, 85201, 9312, 9319) With respect to Investment liberalisation – Market access: Establishment for doctors under the National Health Service is subject to medical manpower planning (CPC 93121, 93122). With respect to Cross-border trade in services – Market access, Local presence, National treatment: The supply of all health-related professional services, including the services provided by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, and psychologists, requires residency. These services may only be provided by natural persons physically present in the territory of the UK (CPC 9312, part of 93191). The cross-border supply of medical, dental and midwives services and services provided by nurses, physiotherapists, psychologists and paramedical personnel (part of CPC 85201, 9312, part of 93191). For service suppliers not physically present in the territory of the UK (part of CPC 85201, 9312, part of 93191). (b) Retail sales of pharmaceutical, medical and orthopaedic goods, other services provided by pharmacists (CPC 63211) With respect to Investment liberalisation – Market access and Cross-border trade in services – Market access, Local presence: Mail order is only possible from the UK, thus establishment in the UK is required for the retail of pharmaceuticals and specific medical goods to the general public in the UK. With respect to Cross-border trade in services – Market access, Local presence, National treatment: The cross-border retail sales of pharmaceuticals and of medical and orthopaedic goods, and other services supplied by pharmacists. Reservation No. 4 – Business services (collection agency services and credit reporting services) Sector– sub-sector: Business services - collection agency services, credit reporting services Industry classification: CPC 87901, 87902 Type of reservation: Market access National treatment Local presence Chapter: Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the supply of collection agency services and credit reporting services. Reservation No. 5 – Business services (placement services) Sector– sub-sector: Business Services – placement services Industry classification: CPC 87202, 87204, 87205, 87206, 87209 Type of reservation: Market access National treatment Senior management and boards of directors Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: The supply of placement services of domestic help personnel, other commercial or industrial workers, nursing and other personnel (CPC 87204, 87205, 87206, 87209). To require establishment and to prohibit the cross-border supply of placement services of office support personnel and other workers. Reservation No. 6 – Business services (investigation services) Sector – sub-sector: Business Services – investigation services Industry classification: CPC 87301 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the supply of investigation services (CPC 87301). Reservation No. 7 – Business services (other business services) Sector– sub-sector: Business services – other business services Industry classification: CPC 86764, 86769, 8868, part of 8790 Type of reservation: Market access National treatment Most favoured nation treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Maintenance and repair of vessels, rail transport equipment and aircraft and parts thereof (part of CPC 86764, CPC 86769, CPC 8868) With respect to Cross-border trade in services – Market access, Local presence, National treatment: To require establishment or physical presence in its territory and prohibiting the cross-border supply of maintenance and repair services of rail transport equipment from outside its territory. To require establishment or physical presence in its territory and prohibiting the cross-border supply of maintenance and repair services of internal waterways transport vessels from outside its territory. To require establishment or physical presence in its territory and prohibiting the cross-border supply of maintenance and repair services of maritime vessels from outside its territory. To require establishment or physical presence in its territory and prohibiting the cross-border supply of maintenance and repair services of aircraft and parts thereof from outside its territory (part of CPC 86764, CPC 86769, CPC 8868). Only recognised organisations authorised by the UK may carry out statutory surveys and certification of ships on behalf of the UK. Establishment may be required. Existing measures: Regulation (EC) 391/2009 of the European Parliament and the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations as retained in UK law by the European Union (Withdrawal) Act 2018, and as amended by the Merchant Shipping (Recognised Organisations) (Amendment) (EU Exit) Regulations 2019. (b) Other business services related to aviation With respect to Investment liberalisation - Most favoured nation treatment and Cross-border trade in Services – Most favoured nation treatment: According differential treatment to a third country pursuant to existing or future bilateral agreements relating to the following services: (i) aircraft repair and maintenance services; (ii) rental or leasing of aircraft without crew; (iii) computer reservation system (CRS) services; (iv) the following services provided using a manned aircraft, subject to compliance with the Parties' respective laws and regulations governing the admission of aircrafts to, departure from and operation within, their territory: aerial fire-fighting, flight training, spraying, surveying, mapping, photography, and other airborne agricultural, industrial and inspection services; and (v) the selling and marketing of air transport services. Reservation No. 8 – Education services Sector: Education services Industry classification: CPC 92 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: All educational services which receive public funding or State support in any form, and are therefore not considered to be privately funded. Where the supply of privately funded education services by a foreign provider is permitted, participation of private operators in the education system may be subject to the granting of a concession allocated on a non-discriminatory basis. The supply of privately funded other education services, which means other than those classified as being primary, secondary, higher and adult education services (CPC 929). Reservation No. 9 – Financial services Sector: Financial services Industry classification: Type of reservation: Market access National treatment Most-favoured-nation treatment Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) All financial services With respect to Investment liberalisation – Market access: To require a financial service supplier, other than a branch, when establishing in the UK to adopt a specific legal form, on a non-discriminatory basis. With respect to Investment liberalisation – Most favoured nation treatment and Cross-border trade in services – Most favoured nation treatment: According differential treatment to an investor or a financial services supplier of a third country pursuant to any bilateral or multilateral international investment treaty or other trade agreement. (b) Insurance and insurance-related services With respect to Cross-border trade in services – Market access, National treatment, Local presence: For the supply of insurance and insurance-related services except for: (i) direct insurance services (including co-insurance) and direct insurance intermediation for the insurance of risks relating to: — maritime transport and commercial aviation and space launching and freight (including satellites), with such insurance to cover any or all of the following: the goods being transported, the vehicle transporting the goods, and any liability deriving therefrom; and — goods in international transit; (ii) Reinsurance and retrocession; and (iii) Services auxiliary to insurance. (c) Banking and other financial services With respect to Investment liberalisation – Market access and Cross-border trade in services – Local presence: Only firms having their registered office in the UK can act as depositories of the assets of investment funds. The establishment of a specialised management company, having its head office and registered office in the UK, is required to perform the activities of management of common funds, including unit trusts, and where allowed under national law, investment companies. With respect to Cross-border trade in services – Market access, National treatment, Local presence: For the supply of banking and other financial services, except for: (i) the provision and transfer of financial information, and financial data processing and related software by suppliers of other financial services; and (ii) advisory and other auxiliary financial services relating to banking and other financial services as described in point (L) of the definition of banking and other financial services (excluding insurance) in Article 183(a)(ii) of this Agreement, but not intermediation as described in that point; Reservation No. 10 – Health and social services Sector: Health and social services Industry classification: CPC 931 other than 9312, part of 93191 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Health services – hospital, ambulance, residential health services (CPC 931 other than 9312, part of 93191) With respect to Investment liberalisation - Market access, National treatment, Performance requirements, Senior management and boards of directors: For the supply of all health services which receive public funding or State support in any form, and are therefore not considered to be privately funded. All privately funded health services other than hospital services. The participation of private operators in the privately funded health network may be subject to concession on a non-discriminatory basis. An economic needs test may apply. Main criteria: number of and impact on existing establishments, transport infrastructure, population density, geographic spread, and creation of new employment. This reservation does not relate to the supply of all health-related professional services, including the services supplied by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, and psychologists, which are covered by other reservations (CPC 931 other than 9312, part of 93191). (b) Health and social services, including pension insurance With respect to Cross-border trade in services – Market access, Local presence, National treatment: Requiring establishment or physical presence in its territory of suppliers and restricting the cross-border supply of health services from outside its territory, the cross-border supply of social services from outside its territory, as well as activities or services forming part of a public retirement plan or statutory system of social security. This reservation does not relate to the supply of all health-related professional services, including the services provided by professionals such as medical doctors, dentists, midwives, nurses, physiotherapists, paramedics, and psychologists, which are covered by other reservations (CPC 931 other than 9312, part of 93191). (c) Social services, including pension insurance With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements: The supply of all social services which receive public funding or State support in any form, and are therefore not considered to be privately funded, and activities or services forming part of a public retirement plan or statutory system of social security. The participation of private operators in the privately funded social network may be subject to concession on a non-discriminatory basis. An economic needs test may apply. Main criteria: number of and impact on existing establishments, transport infrastructure, population density, geographic spread, and creation of new employment. The supply of privately funded social services other than services relating to convalescent and rest houses and old people's homes. Reservation No. 11 – Recreational, cultural and sporting services Sector: Recreational, cultural and sporting services Industry classification: CPC 963, 9619, 964 Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Libraries, archives, museums and other cultural services (CPC 963) The supply of library, archive, museum and other cultural services. (b) Entertainment services, theatre, live bands and circus services (CPC 9619, 964 other than 96492) The cross-border supply of entertainment services, including theatre, live bands, circus and discotheque services. (c) Gambling and betting services (CPC 96492) The supply of gambling activities, which involve wagering a stake with pecuniary value in games of chance, including in particular lotteries, scratch cards, gambling services offered in casinos, gambling arcades or licensed premises, betting services, bingo services and gambling services operated by and for the benefit of charities or non-profit-making organisations. Reservation No. 12 – Transport services and auxiliary transport services Sector: Transport services Type of reservation: Market access National treatment Most favoured nation treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Maritime transport – any other commercial activity undertaken from a ship With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services – Market access, Local presence, National treatment: The nationality of the crew on a seagoing or non-seagoing vessel. With respect to Investment liberalisation – Market access, National treatment, Most favoured nation treatment, Senior management and boards of directors: For the purpose of registering a vessel and operating a fleet under the flag of the UK (all commercial marine activity undertaken from a seagoing ship, including fishing, aquaculture, and services incidental to fishing; international passenger and freight transportation (CPC 721); and services auxiliary to maritime transport). This reservation does not apply to legal persons incorporated in the UK and having an effective and continuous link to its economy. (b) Auxiliary services to maritime transport With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access, Local presence, National treatment: The supply of pilotage and berthing services. For greater certainty, regardless of the criteria which may apply to the registration of ships in the UK, the UK reserves the right to require that only ships registered on the national registers of the UK may provide pilotage and berthing services (CPC 7452). Only vessels carrying the flag of the UK may provide pushing and towing services (CPC 7214). (c) Auxiliary services to inland waterways transport With respect to Investment liberalisation – Market access, National treatment, Most favoured nation treatment, Senior management and boards of directors, Performance requirements and Cross-border trade in services – Market access, Local presence, National treatment, Most favoured nation treatment: Services auxiliary to inland waterways transportation. (d) Rail transport and auxiliary services to rail transport With respect to Investment liberalisation – Market access, National treatment and Cross-Border Trade in Services – Market access, Local presence, National treatment: Railway passenger transportation (CPC 7111). With respect to Investment liberalisation – Market access and Cross-border trade in services – Market access, Local presence: Railway freight transportation (CPC 7112). (e) Road transport (passenger transportation, freight transportation, international truck transport services) and services auxiliary to road transport With respect to Cross-border trade in services – Market access, National treatment, Local presence: For road transport services covered by Heading Three of Part Two of this Agreement and Annex 31 to this Agreement. With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors and Cross-border trade in services – Market access, Local presence, National treatment: For road transport services not covered by Heading Three of Part Two of this Agreement and Annex 31 to this Agreement: (i) to require establishment and to limit the cross-border supply of road transport services (CPC 712); (ii) an economic needs test may apply to taxi services in the UK setting a limit on the number of service suppliers. Main criteria: Local demand as provided in applicable laws (CPC 71221). Existing measures: Regulation (EC) No 1071/2009 of the European Parliament and of the Council of 21 October 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing Council Directive 96/26/EC as retained in UK law by the European Union (Withdrawal) Act 2018 and as amended by the Licensing of Operators and International Road Haulage (Amendment etc.) (EU Exit) Regulations 2019; Regulation (EC) No 1072/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international road haulage market as retained in UK law by the European Union (Withdrawal) Act 2018 and as amended by the Licensing of Operators and International Road Haulage (Amendment etc.) (EU Exit) Regulations 2019; and Regulation (EC) No 1073/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international market for coach and bus services, and amending Regulation (EC) No 561/2006 as retained in UK law by the European Union (Withdrawal) Act 2018 and as amended by the Common Rules for Access to the International Market for Coach and Bus Services (Amendment etc.) (EU Exit) Regulations 2019. (f) Space transport and rental of space craft With respect to Investment Liberalisation – Market access, National treatment, Performance requirements, Senior management and boards of directors and Cross-border trade in services – Market access, Local presence, National treatment: Transportation services via space and the rental of space craft (CPC 733, part of 734). (g) Most-favoured-nation exemptions With respect to Investment liberalisation – Most favoured nation treatment, and Cross-border trade in services – Most favoured nation treatment: (i) Road and rail transport To accord differential treatment to a country pursuant to existing or future bilateral agreements relating to international road haulage (including combined transport – road or rail) and passenger transport, concluded between the UK and a third country (CPC 7111, 7112, 7121, 7122, 7123). That treatment may: — reserve or limit the supply of the relevant transport services between the contracting parties or across the territory of the contracting parties to vehicles registered in each contracting party; or — provide for tax exemptions for such vehicles. (ii) Air transport - Services auxiliary to air transport According differential treatment to a third country pursuant to existing or future bilateral agreements relating to ground-handling services. Reservation No. 13 – Fishing and water Sector: Fishing, aquaculture, services incidental to fishing; collection, purification and distribution of water Industry classification: ISIC Rev. 3.1 0501, 0502, CPC 882, ISIC Rev. 3.1 41 Type of reservation: Market access National treatment Most-favoured-nation treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the following: (a) Fishing, aquaculture and services incidental to fishing (ISIC Rev. 3.1 0501, 0502, CPC 882) With respect to Investment liberalisation – Market access, National treatment, Senior management and boards of directors, Performance requirements, Most favoured nation treatment and Cross-border trade in services – Market access, National treatment, Local presence, Most favoured nation treatment: 1. In particular within the framework of United Kingdom fisheries policy, and of fishing agreements with a third country, access to and use of biological resources and fishing grounds situated in the maritime waters coming under the sovereignty or jurisdiction of the United Kingdom, or entitlements for fishing under a United Kingdom fishing licence, including: (a) regulating the landing of catches by vessels flying the flag of a Member State or a third country with respect to the quotas allocated to them or, only with respect to vessels flying the flag of the United Kingdom, requiring that a proportion of the total catch is landed in United Kingdom ports; (b) determining a minimum size for a company in order to preserve both artisanal and coastal fishing vessels; (c) according differential treatment pursuant to existing or future international agreements relating to fisheries; and (d) requiring the crew of a vessel flying the flag of the United Kingdom to be United Kingdom nationals. 2. A fishing vessel’s entitlement to fly the flag of the United Kingdom only if: (a) it is wholly owned by: (i) companies incorporated in the United Kingdom; or (ii) United Kingdom nationals; (b) its day-to-day operations are directed and controlled from within the United Kingdom; and (c) any charterer, manager or operator of the vessel is a company incorporated in the United Kingdom or a United Kingdom national. 3. A commercial fishing licence granting the right to fish in the territorial waters of the United Kingdom may only be granted to vessels flying the flag of the United Kingdom. 4. The establishment of marine or inland aquaculture facilities. 5. Point (a), (b), (c) (other than with respect to most-favoured nation treatment) and (d) of paragraph 1, point (a)(i), point (b) and (c) of paragraph 2 and paragraph 3 only apply to measures which are applicable to vessels or to enterprises irrespective of the nationality of their beneficial owners. (b) Collection, purification and distribution of water With respect to Investment liberalisation – Market access, National treatment and Cross-border trade in services – Market access, Local presence, National treatment: For activities, including services relating to the collection, purification and distribution of water to household, industrial, commercial or other users, including the supply of drinking water, and water management. Reservation No. 14 – Energy related activities Sector: Production of energy and related services Industry classification: ISIC Rev. 3.1 401, 402, CPC 7131, CPC 887 (other than advisory and consulting services). Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure, where the UK permits foreign ownership of a gas or electricity transmission system, or an oil and gas pipeline transport system, with respect to enterprises of the Union controlled by natural persons or enterprises of a third country which accounts for more than 5 per cent of the UK's oil, natural gas or electricity imports, in order to guarantee the security of the energy supply of the UK. This reservation does not apply to advisory and consultancy services provided as services incidental to energy distribution. Reservation No. 15 – Other services not included elsewhere Sector: Other services not included elsewhere Type of reservation: Market access National treatment Senior management and boards of directors Performance requirements Local presence Chapter: Investment liberalisation and Cross-border trade in services Description: The UK reserves the right to adopt or maintain any measure with respect to the provision of new services other than those classified in the United Nations Provisional Central Product Classification (CPC), 1991. (1) Regulation (EC) No 391/2009 of the European Parliament and the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations (OJ EU L 131 28.5.2009, p. 11). (2) Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ EU L 302, 17.11.2009, p. 32). (3) Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ EU L 174, 1.7.2011, p. 1). (4) Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ EU L 343 14.12.2012, p. 32). (5) Regulation (EC) No 1071/2009 of the European Parliament and of the Council of 21 October 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing Council Directive 96/26/EC (OJ EU L 300, 14.11.2009, p. 51). (6) Regulation (EC) No 1072/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international road haulage market (OJ EU L 300, 14.11.2009, p. 72). (7) Regulation (EC) No 1073/2009 of the European Parliament and of the Council of 21 October 2009 on common rules for access to the international market for coach and bus services, and amending Regulation (EC) No 561/2006 (OJ EU L 300 14.11.2009, p. 88). (8) With regard to Austria the part of the most-favoured-nation treatment exemption regarding traffic rights covers all countries with whom bilateral agreements on road transport or other arrangements relating to road transport exist or may be considered in future. (9) Directive (EU) 2019/944 of the European Parliament and of the Council of 5 June 2019 on common rules for the internal market for electricity and amending Directive 2012/27/EU (OJ EU L 158, 14.6.2019, p. 125). (10) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ EU L 211, 14.8.2009, p. 94). (11) Directive 96/92/EC of the European Parliament and of the Council of 19 December 1996 concerning common rules for the internal market in electricity (OJ EU L 27, 30.1.1997, p. 20). (12) Directive 2003/54/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in electricity and repealing Directive 96/92/EC (OJ EU L 176, 15.7.2003, p. 37). (13) Directive 98/30/EC of the European Parliament and the Council of 22 June 1998 concerning common rules for the internal market in natural gas (OJ EU L 204, 21.7.1998, p. 1). ANNEX 21 BUSINESS VISITORS FOR ESTABLISHMENT PURPOSES, INTRA-CORPORATE TRANSFEREES AND SHORT-TERM BUSINESS VISITORS 1. A measure listed in this Annex may be maintained, continued, promptly renewed, or amended, provided that the amendment does not decrease the conformity of the measure with Articles 141 and 142 of this Agreement, as it existed immediately before the amendment. 2. Articles 141 and 142 of this Agreement do not apply to any existing non-conforming measure listed in this Annex, to the extent of the non-conformity. 3. The schedules in paragraphs 6, 7 and 8 apply only to the territories of the United Kingdom and the Union in accordance with Article 520(2) and Article 774 of this Agreement and are only relevant in the context of trade relations between the Union and its Member States with the United Kingdom. They do not affect the rights and obligations of the Member States under Union law. 4. For greater certainty, for the Union, the obligation to grant national treatment does not entail the requirement to extend to natural or legal persons of the United Kingdom the treatment granted in a Member State, in application of the Treaty on the Functioning of the European Union, or of any measure adopted pursuant to that Treaty, including their implementation in the Member States, to: (i) natural persons or residents of another Member State; or (ii) legal persons constituted or organised under the law of another Member State or of the Union and having their registered office, central administration or principal place of business in the Union. 5. The following abbreviations are used in the paragraphs below: AT Austria BE Belgium BG Bulgaria CY Cyprus CZ Czechia DE Germany DK Denmark EE Estonia EL Greece ES Spain EU European Union, including all its Member States FI Finland FR France HR Croatia HU Hungary IE Ireland IT Italy LT Lithuania LU Luxembourg LV Latvia MT Malta NL The Netherlands PL Poland PT Portugal RO Romania SE Sweden SI Slovenia SK Slovak Republic 6. The Union's non-conforming measures are: Business visitors for establishment purposes All sectors AT, CZ: Business visitor for establishment purposes needs to work for an enterprise other than a non-profit organisation, otherwise: Unbound. SK: Business visitor for establishment purposes needs to work for an enterprise other than a non-profit organisation, otherwise: Unbound. Work permit required, including economic needs test. CY: Permissible length of stay: up to 90 days in any twelve month period. Business visitor for establishment purposes needs to work for an enterprise other than a non-profit organisation, otherwise: Unbound. Intra-corporate transferees All sectors EU: Until 31 December 2022 any charge, fee or tax imposed by a Party (other than fees associated with the processing of a visa, work permit, or residency permit application or renewal) on the grounds of being allowed to perform an activity or to hire a person who can perform such activity in the territory of a Party, unless it is a requirement consistent with Article 140(3) of this Agreement, or a health fee under national legislation in connection with an application for a permit to enter, stay, work, or reside in the territory of a Party. AT, CZ, SK: Intra-corporate transferees need to be employed by an enterprise other than a non-profit organisation, otherwise: Unbound. FI: Senior personnel needs to be employed by an enterprise other than a non-profit organisation. HU: Natural persons who have been a partner in an enterprise do not qualify to be transferred as intra-corporate transferees. Short-term business visitors All activities referred to in paragraph 8: CY, DK, HR: Work permit, including economic needs test, required in case the short-term business visitor supplies a service. LV: Work permit required for operations/activities to be performed on the basis of a contract. MT: Work permit required. No economic needs tests performed. SI: A single residency and work permit is required for the supply of services exceeding 14 days at a time and for certain activities (research and design; training seminars; purchasing; commercial transactions; translation and interpretation). An economic needs test is not required. SK: In case of supplying a service in the territory of Slovakia, a work permit, including economic needs test, is required beyond seven days in a month or 30 days in calendar year. Research and design AT: Work permit, including economic needs test, required, except for research activities of scientific and statistical researchers. Marketing research AT: Work permit required, including economic needs test. Economic needs test is waived for research and analysis activities for up to seven days in a month or 30 days in a calendar year. University degree required. CY: Work permit required, including economic needs test. Trade fairs and exhibitions AT, CY: Work permit, including economic needs test, required for activities beyond seven days in a month or 30 days in a calendar year. After-sales or after-lease service AT: Work permit required, including economic needs test. Economic needs test is waived for natural persons training workers to supply services and possessing specialisedge knowledge. CY, CZ : Work permit is required beyond seven days in a month or 30 days in calendar year. ES: Installers, repair and maintainers should be employed as such by the legal person supplying the good or service or by an enterprise which is a member of the same group as the originating legal person for at least three months immediately preceding the date of submission of an application for entry and they should possess at least 3 years of relevant professional experience, where applicable, obtained after the age of majority. FI: Depending on the activity, a residence permit may be required. SE: Work permit required, except for (i) natural persons who participate in training, testing, preparation or completion of deliveries, or similar activities within the framework of a business transaction, or (ii) fitters or technical instructors in connection with urgent installation or repair of machinery for up to two months, in the context of an emergency. No economic needs test required. Commercial transactions AT, CY: Work permit, including economic needs test, required for activities beyond seven days in a month or 30 days in a calendar year. FI: The natural person needs to be supplying services as an employee of a legal person of the other Party. Tourism personnel CY, ES, PL: Unbound. FI: The natural person needs to be supplying services as an employee of a legal person of the other Party. SE: Work permit required, except for drivers and staff of tourist buses. No economic needs test required. Translation and interpretation AT: Work permit required, including economic needs test. CY, PL: Unbound. 7. The United Kingdom's non-conforming measures are: Business visitors for establishment purposes All sectors Business visitor for establishment purposes needs to work for an enterprise other than a non-profit organisation, otherwise: Unbound. Intra-corporate transferees All sectors Intra-corporate transferees need to be employed by an enterprise other than a non-profit organisation, otherwise: Unbound. Until 31 December 2022 any charge, fee or tax imposed by a Party (other than fees associated with the processing of a visa, work permit, or residency permit application or renewal) on the grounds of being allowed to perform an activity or to hire a person who can perform such activity in the territory of a Party, unless it is a requirement consistent with Article 140(3) of this Agreement, or a health fee under national legislation in connection with an application for a permit to enter, stay, work, or reside in the territory of a Party. Short-term business visitors All activities referred to in paragraph 8: None 8. The activities Short-term business visitors are permitted to engage in are: (a) meetings and consultations: natural persons attending meetings or conferences, or engaged in consultations with business associates; (b) research and design: technical, scientific and statistical researchers conducting independent research or research for a legal person of the Party of which the Short-term business visitor is a natural person; (c) marketing research: market researchers and analysts conducting research or analysis for a legal person of the Party of which the Short-term business visitor is a natural person; (d) training seminars: personnel of an enterprise who enter the territory being visited by the Short-term business visitor to receive training in techniques and work practices which are utilised by companies or organisations in the territory being visited by the Short-term business visitor, provided that the training received is confined to observation, familiarisation and classroom instruction only; (e) trade fairs and exhibitions: personnel attending a trade fair for the purpose of promoting their company or its products or services; (f) sales: representatives of a supplier of services or goods taking orders or negotiating the sale of services or goods or entering into agreements to sell services or goods for that supplier, but not delivering goods or supplying services themselves. Short-term business visitors shall not engage in making direct sales to the general public; (g) purchasing: buyers purchasing goods or services for an enterprise, or management and supervisory personnel, engaging in a commercial transaction carried out in the territory of the Party of which the Short-term business visitor is a natural person; (h) after-sales or after-lease service: installers, repair and maintenance personnel and supervisors, possessing specialised knowledge essential to a seller's contractual obligation, supplying services or training workers to supply services pursuant to a warranty or other service contract incidental to the sale or lease of commercial or industrial equipment or machinery, including computer software, purchased or leased from a legal person of the Party of which the Short-term business visitor is a natural person throughout the duration of the warranty or service contract; (i) commercial transactions: management and supervisory personnel and financial services personnel (including insurers, bankers and investment brokers) engaging in a commercial transaction for a legal person of the Party of which the Short-term business visitor is a natural person; (j) tourism personnel: tour and travel agents, tour guides or tour operators attending or participating in conventions or accompanying a tour that has begun in the territory of the Party of which the Short-term business visitor is a natural person; and (k) translation and interpretation: translators or interpreters supplying services as employees of a legal person of the Party of which the Short-term business visitor is a natural person. ANNEX 22 CONTRACTUAL SERVICE SUPPLIERS AND INDEPENDENT PROFESSIONALS 1. Each Party shall allow the supply of services in its territory by contractual service suppliers or independent professionals of the other Party through the presence of natural persons, in accordance with Article 143 of this Agreement, for the sectors listed in this Annex and subject to the relevant limitations. 2. The list below is composed of the following elements: (a) the first column indicating the sector or sub-sector for which the category of contractual service suppliers and independent professionals is liberalised; and (b) the second column describing the applicable limitations. 3. In addition to the list of reservations in this Annex, each Party may adopt or maintain a measure relating to qualification requirements, qualification procedures, technical standards, licensing requirements or licensing procedures that does not constitute a limitation within the meaning of Article 143 of this Agreement. These measures, which include requirements to obtain a licence, obtain recognition of qualifications in regulated sectors or to pass specific examinations, such as language examinations, even if not listed in this Annex, apply in any case to contractual service suppliers or independent professionals of the Parties. 4. The Parties do not undertake any commitment for contractual service suppliers and independent professionals in economic activities which are not listed. 5. In identifying individual sectors and sub-sectors: CPC means the Central Products Classification as set out in Statistical Office of the United Nations, Statistical Papers, Series M, N° 77, CPC prov., 1991. 6. In the sectors where economic needs tests are applied, their main criteria will be the assessment of: (a) for the United Kingdom, the relevant market situation in the United Kingdom; and (b) for the Union, the relevant market situation in the Member State or the region where the service is to be provided, including with respect to the number of, and the impact on, services suppliers who are already supplying a service when the assessment is made. 7. The schedules in paragraphs 10 to 13 apply only to the territories of the United Kingdom and the Union in accordance with Article 520(2) and Article 774 of this Agreement and are only relevant in the context of trade relations between the Union and its Member States with the United Kingdom. They do not affect the rights and obligations of the Member States under Union law. 8. For greater certainty, for the Union, the obligation to grant national treatment does not entail the requirement to extend to natural or legal persons of the United Kingdom the treatment granted in a Member State, in application of the Treaty on the Functioning of the European Union, or of any measure adopted pursuant to that Treaty, including their implementation in the Member States, to: (i) natural persons or residents of another Member State; or (ii) legal persons constituted or organised under the law of another Member State or of the Union and having their registered office, central administration or principal place of business in the Union. 9. The following abbreviations are used in the lists below: AT Austria BE Belgium BG Bulgaria CY Cyprus CZ Czechia DE Germany DK Denmark EE Estonia EL Greece ES Spain EU European Union, including all its Member States FI Finland FR France HR Croatia HU Hungary IE Ireland IT Italy LT Lithuania LU Luxembourg LV Latvia MT Malta NL The Netherlands PL Poland PT Portugal RO Romania SE Sweden SI Slovenia SK Slovak Republic CSS Contractual Service Suppliers IP Independent Professionals Contractual Service Suppliers 10. Subject to the list of reservations in paragraphs 12 and 13, the Parties take commitments in accordance with Article 143 of this Agreement with respect to the mode 4 category of Contractual Service Suppliers in the following sectors or sub-sectors: (a) Legal advisory services in respect of public international law and home jurisdiction law; (b) Accounting and bookkeeping services; (c) Taxation advisory services; (d) Architectural services and urban planning and landscape architectural services; (e) Engineering services and integrated engineering services; (f) Medical and dental services; (g) Veterinary services; (h) Midwives services; (i) Services provided by nurses, physiotherapists and paramedical personnel; (j) Computer and related services; (k) Research and development services; (l) Advertising services; (m) Market research and opinion polling; (n) Management consulting services; (o) Services related to management consulting; (p) Technical testing and analysis services; (q) Related scientific and technical consulting services; (r) Mining; (s) Maintenance and repair of vessels; (t) Maintenance and repair of rail transport equipment; (u) Maintenance and repair of motor vehicles, motorcycles, snowmobiles and road transport equipment; (v) Maintenance and repair of aircrafts and parts thereof; (w) Maintenance and repair of metal products, of (non office) machinery, of (non transport and non office) equipment and of personal and household goods; (x) Translation and interpretation services; (y) Telecommunication services; (z) Postal and courier services; (aa) Construction and related engineering services; (bb) Site investigation work; (cc) Higher education services; (dd) Services relating to agriculture, hunting and forestry; (ee) Environmental services; (ff) Insurance and insurance related services advisory and consulting services; (gg) Other financial services advisory and consulting services; (hh) Transport advisory and consulting services; (ii) Travel agencies and tour operators' services; (jj) Tourist guides services; (kk) Manufacturing advisory and consulting services. Independent Professionals 11. Subject to the list of reservations in paragraphs 12 and 13, the Parties take commitments in accordance with Article 143 of this Agreement with respect to the mode 4 category of Independent Professionals in the following sectors or sub-sectors: (a) Legal advisory services in respect of public international law and home jurisdiction law; (b) Architectural services and urban planning and landscape architectural services; (c) Engineering services and integrated engineering services; (d) Computer and related services; (e) Research and development services; (f) Market research and opinion polling; (g) Management consulting services; (h) Services related to management consulting; (i) Mining; (j) Translation and interpretation services; (k) Telecommunication services; (l) Postal and courier services (m) Higher education services; (n) Insurance related services advisory and consulting services; (o) Other financial services advisory and consulting services; (p) Transport advisory and consulting services; (q) Manufacturing advisory and consulting services. 12. The Union's reservations are: Sector or sub-sector Description of reservations All sectors CSS and IP: In AT: Maximum stay shall be for a cumulative period of not more than six months in any 12 month period or for the duration of the contract, whichever is less. In CZ: Maximum stay shall be for a period of not more than 12 consecutive months or for the duration of the contract, whichever is less. Legal advisory services in respect of public international law and home jurisdiction law (part of CPC 861) CSS: In AT, BE, CY, DE, EE, EL, ES, FR, HR, IE, IT, LU, NL, PL, PT, SE: None. In BG, CZ, DK, FI, HU, LT, LV, MT, RO, SI, SK: Economic needs test. IP: In AT, CY, DE, EE, FR, HR, IE, LU, LV, NL, PL, PT, SE: None. In BE, BG, CZ, DK, EL, ES, FI, HU, IT, LT, MT, RO, SI, SK: Economic needs tests. Accounting and bookkeeping services (CPC 86212 other than "auditing services", 86213, 86219 and 86220) CSS: In AT, BE, DE, EE, ES, HR, IE, IT, LU, NL, PL, PT, SI, SE: None. In BG, CZ, CY, DK, EL, FI, FR, HU, LT, LV, MT, RO, SK: Economic needs test. IP: EU: Unbound. Taxation advisory services (CPC 863) (1) CSS: In AT, BE, DE, EE, ES, FR, HR, IE, IT, LU, NL, PL, SI, SE: None. In BG, CZ, CY, DK, EL, FI, HU, LT, LV, MT, RO, SK: Economic needs test. In PT: Unbound. IP: EU: Unbound. Architectural services and Urban planning and landscape architectural services (CPC 8671 and 8674) CSS: In BE, CY, EE, ES, EL, FR, HR, IE, IT, LU, MT, NL, PL, PT, SI, SE: None. In FI: None, except: The natural person must demonstrate that he or she possesses special knowledge relevant to the service being supplied. In BG, CZ, DE, HU, LT, LV, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. In AT: Planning services only, where: Economic needs test. IP: In CY, DE, EE, EL, FR, HR, IE, LU, LV, MT, NL, PL, PT, SI, SE: None. In FI: None, except: The natural person must demonstrate that he or she possesses special knowledge relevant to the service being supplied. In BE, BG, CZ, DK, ES, HU, IT, LT, RO, SK: Economic needs test. In AT: Planning services only, where: Economic needs test. Engineering services and Integrated engineering services (CPC 8672 and 8673) CSS: In BE, CY, EE, ES, EL, FR, HR, IE, IT, LU, MT, NL, PL, PT, SI, SE: None. In FI: None, except: The natural person must demonstrate that he or she possesses special knowledge relevant to the service being supplied. In BG, CZ, DE, HU, LT, LV, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. In AT: Planning services only, where: Economic needs test. IP: In CY, DE, EE, EL, FR, HR, IE, LU, LV, MT, NL, PL, PT, SI, SE: None. In FI: None, except: The natural person must demonstrate that he or she possesses special knowledge relevant to the service being supplied. In BE, BG, CZ, DK, ES, HU, IT, LT, RO, SK: Economic needs test. In AT: Planning services only, where: Economic needs test. Medical (including psychologists) and dental services (CPC 9312 and part of 85201) CSS: In SE: None. In CY, CZ, DE, DK, EE, ES, IE, IT, LU, MT, NL, PL, PT, RO, SI: Economic needs test. In FR: Economic needs test, except for psychologists, where: Unbound. In AT: Unbound, except for psychologists and dental services, where: Economic needs test. In BE, BG, EL, FI, HR, HU, LT, LV, SK: Unbound. IP: EU: Unbound. Veterinary services (CPC 932) CSS: In SE: None. In CY, CZ, DE, DK, EE, EL, ES, FI, FR, IE, IT, LT, LU, MT, NL, PL, PT, RO, SI: Economic needs test. In AT, BE, BG, HR, HU, LV, SK: Unbound. IP: EU: Unbound. Midwives services (part of CPC 93191) CSS: In IE, SE: None. In AT, CY, CZ, DE, DK, EE, EL, ES, FR, IT, LT, LV, LU, MT, NL, PL, PT, RO, SI: Economic needs test. In BE, BG, FI, HR, HU, SK: Unbound. IP: EU: Unbound. Services provided by nurses, physiotherapists and paramedical personnel (part of CPC 93191) CSS: In IE, SE: None. In AT, CY, CZ, DE, DK, EE, EL, ES, FR, IT, LT, LV, LU, MT, NL, PL, PT, RO, SI: Economic needs test. In BE, BG, FI, HR, HU, SK: Unbound. IP: EU: Unbound. Computer and related services (CPC 84) CSS: In BE, DE, EE, EL, ES, FR, HR, IE, IT, LU, LV, MT, NL, PL, PT, SI, SE: None. In FI: None, except: The natural person must demonstrate that he or she possesses special knowledge relevant to the service being supplied. In AT, BG, CZ, CY, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test except for CSS stays of up to three months. IP: In DE, EE, EL, FR, IE, LU, LV, MT, NL, PL, PT, SI, SE: None. In FI: None, except: The natural person must demonstrate that he or she possesses special knowledge relevant to the service being supplied. In AT, BE, BG, CZ, CY, DK, ES, HU, IT, LT, RO, SK: Economic needs test. In HR: Unbound. Research and development Services (CPC 851, 852 excluding psychologists services (2), and 853) CSS: EU except in NL, SE: A hosting agreement with an approved research organisation is required (3). EU except in CZ, DK, SK: None In CZ, DK, SK: Economic needs test. IP: EU except in NL, SE: A hosting agreement with an approved research organisation is required (4). EU except in BE, CZ, DK, IT, SK: None In BE, CZ, DK, IT, SK: Economic needs test. Advertising services (CPC 871) CSS: In BE, DE, EE, ES, FR, HR, IE, IT, LU, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, DK, EL, FI, HU, LT, LV, MT, RO, SK: Economic needs test. IP: EU: Unbound, except NL. In NL: None. Market research and opinion polling services (CPC 864) CSS: In BE, DE, EE, ES, FR, IE, IT, LU, NL, PL, SE: None. In AT, BG, CZ, CY, DK, EL, FI, HR, LV, MT, RO, SI, SK: Economic needs test. In PT: None, except for public opinion polling services (CPC 86402), where: Unbound. In HU, LT: Economic needs test, except for public opinion polling services (CPC 86402), where: Unbound. IP: In DE, EE, FR, IE, LU, NL, PL, SE: None. In AT, BE, BG, CZ, CY, DK, EL, ES, FI, HR, IT, LV, MT, RO, SI, SK: Economic needs test. In PT: None, except for public opinion polling services (CPC 86402), where: Unbound. In HU, LT: Economic needs test, except for public opinion polling services (CPC 86402), where: Unbound. Management consulting services (CPC 865) CSS: In BE, DE, EE, EL, ES, FI, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: In CY, DE, EE, EL, FI, FR, IE, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BE, BG, CZ, DK, ES, HR, HU, IT, LT, RO, SK: Economic needs test. Services related to management consulting (CPC 866) CSS: In BE, DE, EE, EL, ES, FI, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. In HU: Economic needs test, except for arbitration and conciliation services (CPC 86602), where: Unbound. IP: In CY, DE, EE, EL, FI, FR, IE, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BE, BG, CZ, DK, ES, HR, IT, LT, RO, SK: Economic needs test In HU: Economic needs test, except for arbitration and conciliation services (CPC 86602), where: Unbound. Technical testing and analysis services (CPC 8676) CSS: In BE, DE, EE, EL, ES, FR, HR, IE, IT, LU, NL, PL, SI, SE: None. In AT, BG, CZ, CY, FI, HU, LT, LV, MT, PT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: EU: Unbound, except NL. In NL: None. Related scientific and technical consulting services (CPC 8675) CSS: In BE, EE, EL, ES, HR, IE, IT, LU, NL, PL, SI, SE: None. In AT, CZ,CY, DE, DK, FI, HU, LT, LV, MT, PT, RO, SK: Economic needs test. In DE: None, except for publicly appointed surveyors, where: Unbound. In FR: None, except for "surveying" operations relating to the establishment of property rights and to land law, where: Unbound. In BG: Unbound. IP: EU: Unbound, except NL. In NL: None. Mining (CPC 883, advisory and consulting services only) CSS: In BE, DE, EE, EL, ES, FI, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ,CY, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: In DE, EE, EL, FI, FR, HR, IE, LV, LU, MT, NL, PT, SI, SE: None. In AT, BE, BG, CZ, CY, DK, ES, HU, IT, LT, PL, RO, SK: Economic needs test. Maintenance and repair of vessels (part of CPC 8868) CSS: In BE, EE, EL, ES, FR, HR, IT, LV, LU, NL, PL, PT, SI, SE: None In AT, BG, CZ, CY, DE, DK, FI, HU, IE, LT, MT, RO, SK: Economic needs test. IP: EU: Unbound, except NL. In NL: None. Maintenance and repair of rail transport equipment (part of CPC 8868) CSS: In BE, EE, EL, ES, FR, HR, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, DE, DK, FI, HU, IE, LT, RO, SK: Economic needs test. IP: EU: Unbound, except NL. In NL: None. Maintenance and repair of motor vehicles, motorcycles, snowmobiles and road transport equipment (CPC 6112, 6122, part of 8867 and part of 8868) CSS: In BE, EE, EL, ES, FR, HR, IT, LV, LU, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, DE, DK, FI, HU, IE, LT, MT, RO, SK: Economic needs test. IP: EU: Unbound, except NL. In NL: None. Maintenance and repair of aircraft and parts thereof (part of CPC 8868) CSS: In BE, EE, EL, ES, FR, HR, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, DE, DK, FI, HU, IE, LT, RO, SK: Economic needs test. IP: EU: Unbound, except NL. In NL: None. Maintenance and repair of metal products, of (non office) machinery, of (non transport and non office) equipment and of personal and household goods (5) (CPC 633, 7545, 8861, 8862, 8864, 8865 and 8866) CSS: In BE, EE, EL, ES, FR, HR, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, DE, DK, HU, IE, LT, RO, SK: Economic needs test. In FI: Unbound, except in the context of an after-sales or after-lease contract; for maintenance and repair of personal and household goods (CPC 633): Economic needs test. IP: EU: Unbound, except NL. In NL: None. Translation and interpretation services (CPC 87905, excluding official or certified activities) CSS: In BE, CY, DE, EE, EL, ES, FR, HR, IT, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, DK, FI, HU, IE, LT, LV, RO, SK: Economic needs test. IP: In CY, DE, EE, FR, LU, LV, MT, NL, PL, PT, SI, SE: None. In AT, BE, BG, CZ, DK, EL, ES, FI, HU, IE, IT, LT, RO, SK: Economic needs test. In HR: Unbound. Telecommunication services (CPC 7544, advisory and consulting services only) CSS: In BE, DE, EE, EL, ES, FI, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: In DE, EE, EL, FI, FR, HR, IE, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BE, BG, CZ, CY, DK, ES, HU, IT, LT, RO, SK: Economic needs test. Postal and courier services (CPC 751, advisory and consulting services only) CSS: In BE, DE, EE, EL, ES, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, FI, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: In DE, EE, EL, FR, HR, IE, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BE, BG, CZ, CY, DK, ES, FI, HU, IT, LT, RO, SK: Economic needs test. Construction and related engineering services (CPC 511, 512, 513, 514, 515, 516, 517 and 518. BG: CPC 512, 5131, 5132, 5135, 514, 5161, 5162, 51641, 51643, 51644, 5165 and 517) CSS: EU: Unbound except in BE, CZ, DK, ES, NL and SE. In BE, DK, ES, NL, SE: None. In CZ: Economic needs test. IP: EU: Unbound, except NL. In NL: None. Site investigation work (CPC 5111) CSS: In BE, DE, EE, EL, ES, FR, HR, IE, IT, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ,CY, FI, HU, LT, LV, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: EU: Unbound. Higher education services (CPC 923) CSS: EU except in LU, SE: Unbound. In LU: Unbound, except for university professors, where: None. In SE: None, except for publicly funded and privately funded educational services suppliers with some form of State support, where: Unbound. IP: EU except in SE: Unbound. In SE: None, except for publicly funded and privately funded educational services suppliers with some form of State support, where: Unbound. Agriculture, hunting and forestry (CPC 881, advisory and consulting services only) CSS: EU except in BE, DE, DK, ES, FI, HR and SE: Unbound In BE, DE, ES, HR, SE: None In DK: Economic needs test. In FI: Unbound, except for advisory and consulting services relating to forestry, where: None. IP: EU: Unbound. Environmental services (CPC 9401, 9402, 9403, 9404, part of 94060, 9405, part of 9406 and 9409) CSS: In BE, EE, ES, FI, FR, HR, IE, IT, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, DE, DK, EL, HU, LT, LV, RO, SK: Economic needs test. IP: EU: Unbound. Insurance and insurance related services (advisory and consulting services only) CSS: In BE, DE, EE, EL, ES, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ,CY, FI, LT, RO, SK: Economic needs test. In DK: Economic needs test except for CSS stays of up to three months. In HU: Unbound. IP: In DE, EE, EL, FR, HR, IE, LV, LU, MT, NL, PT, SI, SE: None. In AT, BE, BG, CZ, CY, DK, ES, FI, IT, LT, PL, RO, SK: Economic needs test. In HU: Unbound. Other financial services (advisory and consulting services only) CSS: In BE, DE, ES, EE, EL, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, FI, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS that stays of up to three months. In HU: Unbound. IP: In DE, EE, EL, FR, HR, IE, LV, LU, MT, NL, PT, SI, SE: None. In AT, BE, BG, CZ, CY, DK, ES, FI, IT, LT, PL, RO, SK: Economic needs test. In HU: Unbound. Transport (CPC 71, 72, 73, and 74, advisory and consulting services only) CSS: In DE, EE, EL, ES, FI, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. In BE: Unbound. IP: In CY, DE, EE, EL, FI, FR, HR, IE, LV, LU, MT, NL, PT, SI, SE: None. In AT, BG, CZ, DK, ES, HU, IT, LT, RO, SK: Economic needs test. In PL: Economic needs test, except for air transport, where: None. In BE: Unbound. Travel agencies and tour operators services (including tour managers (6)) (CPC 7471) CSS: In AT, CY, CZ, DE, EE, ES, FR, HR, IT, LU, NL, PL, SI, SE: None. In BG, EL, FI, HU, LT, LV, MT, PT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. In BE, IE: Unbound, except for tour managers, where: None. IP: EU: Unbound. Tourist guides services (CPC 7472) CSS: In NL, PT, SE: None. In AT, BE, BG, CY, CZ, DE, DK, EE, FI, FR, EL, HU, IE, IT, LV, LU, MT, RO, SK, SI: Economic needs test. In ES, HR, LT, PL: Unbound. IP: EU: Unbound. Manufacturing (CPC 884, and 885, advisory and consulting services only) CSS: In BE, DE, EE, EL, ES, FI, FR, HR, IE, IT, LV, LU, MT, NL, PL, PT, SI, SE: None. In AT, BG, CZ, CY, HU, LT, RO, SK: Economic needs test. In DK: Economic needs test, except for CSS stays of up to three months. IP: In DE, EE, EL, FI, FR, HR, IE, LV, LU, MT, NL, PT, SI, SE: None. In AT, BE, BG, CZ, CY, DK, ES, HU, IT, LT, PL, RO, SK: Economic needs test. 13. The United Kingdom's reservations are: Sector or sub-sector Description of reservations All sectors None Legal advisory services in respect of public international law and home jurisdiction law (part of CPC 861) CSS: None. IP: None. Accounting and bookkeeping services (CPC 86212 other than "auditing services", 86213, 86219 and 86220) CSS: None. IP: Unbound. Taxation advisory services (CPC 863) (7) CSS: None. IP: Unbound. Architectural services and Urban planning and landscape architectural services (CPC 8671 and 8674) CSS: None. IP: None. Engineering services and Integrated engineering services (CPC 8672 and 8673) CSS: None. IP: None. Medical (including psychologists) and dental services (CPC 9312 and part of 85201) CSS: Unbound. IP: Unbound. Veterinary services (CPC 932) CSS: Unbound. IP: Unbound. Midwives services (part of CPC 93191) CSS: Unbound. IP: Unbound. Services provided by nurses, physiotherapists and paramedical personnel (part of CPC 93191) CSS: Unbound. IP: Unbound. Computer and related services (CPC 84) CSS: UK: None. IP: None. Research and development Services (CPC 851, 852 excluding psychologists services (8), and 853) CSS: None IP: None Advertising services (CPC 871) CSS: None. IP: Unbound. Market research and opinion polling services (CPC 864) CSS: None. IP: None. Management consulting services (CPC 865) CSS: None. IP: None. Services related to management consulting (CPC 866) CSS: None. IP: None. Technical testing and analysis services (CPC 8676) CSS: None. IP: Unbound. Related scientific and technical consulting services (CPC 8675) CSS: None. IP: Unbound. Mining (CPC 883, advisory and consulting services only) CSS: None. IP: None. Maintenance and repair of vessels (part of CPC 8868) CSS: None IP: Unbound. Maintenance and repair of rail transport equipment (part of CPC 8868) CSS: None. IP: Unbound. Maintenance and repair of motor vehicles, motorcycles, snowmobiles and road transport equipment (CPC 6112, 6122, part of 8867 and part of 8868) CSS: None. IP: Unbound. Maintenance and repair of aircraft and parts thereof (part of CPC 8868) CSS: None. IP: Unbound. Maintenance and repair of metal products, of (non office) machinery, of (non transport and non office) equipment and of personal and household goods (9) (CPC 633, 7545, 8861, 8862, 8864, 8865 and 8866) CSS: None. IP: Unbound. Translation and interpretation services (CPC 87905, excluding official or certified activities) CSS: None. IP: None. Telecommunication services (CPC 7544, advisory and consulting services only) CSS: None. IP: None. Postal and courier services (CPC 751, advisory and consulting services only) CSS: None. IP: None. Construction and related engineering services (CPC 511, 512, 513, 514, 515, 516, 517 and 518. BG: CPC 512, 5131, 5132, 5135, 514, 5161, 5162, 51641, 51643, 51644, 5165 and 517) CSS: Unbound. IP: Unbound. Site investigation work (CPC 5111) CSS: None. IP: Unbound. Higher education services (CPC 923) CSS: Unbound. IP: Unbound. Agriculture, hunting and forestry (CPC 881, advisory and consulting services only) CSS: Unbound IP: Unbound. Environmental services (CPC 9401, 9402, 9403, 9404, part of 94060, 9405, part of 9406 and 9409) CSS: None. IP: Unbound. Insurance and insurance related services (advisory and consulting services only) CSS: None. IP: None. Other financial services (advisory and consulting services only) CSS: None. IP: None. Transport (CPC 71, 72, 73, and 74, advisory and consulting services only) CSS: None. IP: None. Travel agencies and tour operators services (including tour managers (10)) (CPC 7471) CSS: None. IP: Unbound. Tourist guides services (CPC 7472) CSS: None. IP: Unbound. Manufacturing (CPC 884, and 885, advisory and consulting services only) CSS: None. IP: None. (1) Does not include legal advisory and legal representational services on tax matters, which are under legal advisory services in respect of public international law and home jurisdiction law. (2) Part of CPC 85201, which is under medical and dental services. (3) For all Member States except DK, the approval of the research organisation and the hosting agreement must meet the conditions set pursuant to EU Directive 2005/71/EC of 12 October 2005. (4) For all Member States except DK, the approval of the research organisation and the hosting agreement must meet the conditions set pursuant to EU Directive 2005/71/EC of 12 October 2005. (5) Maintenance and repair services of office machinery and equipment including computers (CPC 845) are under computer services. (6) Services suppliers whose function is to accompany a tour group of a minimum of 10 natural persons, without acting as guides in specific locations. (7) Does not include legal advisory and legal representational services on tax matters, which are under legal advisory services in respect of public international law and home jurisdiction law. (8) Part of CPC 85201, which is under medical and dental services. (9) Maintenance and repair services of office machinery and equipment including computers (CPC 845) are under computer services. (10) Services suppliers whose function is to accompany a tour group of a minimum of 10 natural persons, without acting as guides in specific locations. ANNEX 23 MOVEMENT OF NATURAL PERSONS Article 1 Entry and temporary stay-related procedural commitments The Parties shall endeavour to ensure that the processing of applications for entry and temporary stay pursuant to their respective commitments in the Agreement follows good administrative practice: (a) Each Party shall ensure that fees charged by competent authorities for the processing of applications for entry and temporary stay do not unduly impair or delay trade in services under this Agreement; (b) subject to the discretion of the competent authorities of each Party, documents required from an applicant for applications for the grant of entry and temporary stay of short-term visitors for business purposes should be commensurate with the purpose for which they are collected; (c) complete applications for the grant of entry and temporary stay shall be processed by the competent authorities of each Party as expeditiously as possible; (d) the competent authorities of each Party shall endeavour to provide, without undue delay, information in response to any reasonable request from an applicant concerning the status of an application; (e) if the competent authorities of a Party require additional information from an applicant in order to process the application, they shall endeavour to notify, without undue delay, the applicant; (f) the competent authorities of each Party shall notify the applicant of the outcome of the application promptly after a decision has been taken; (g) if an application is approved, the competent authorities of each Party shall notify the applicant of the period of stay and other relevant terms and conditions; (h) if an application is denied, the competent authorities of a Party shall, upon request or upon their own initiative make available to the applicant information on any available review and appeal procedures; and (i) each Party shall endeavour to accept and process applications in electronic format. Article 2 Additional procedural commitments applying to intra-corporate transferees and their partner, children and family members (1) 1. The competent authorities of each Party shall adopt a decision on an application for an intra-corporate transferee entry or temporary stay or a renewal thereof and notify the decision to the applicant in writing, in accordance with the notification procedures under national law, as soon as possible but not later than 90 days after the date on which the complete application was submitted. 2. Where the information or documentation supplied in support of the application is incomplete, the competent authorities concerned shall endeavour to notify the applicant within a reasonable period of the additional information that is required and set a reasonable deadline for providing it. The period referred to in paragraph 1 shall be suspended until the competent authorities have received the additional information required. 3. The Union shall extend to family members of natural persons of the United Kingdom, who are intra-corporate transferees to the Union, the right of entry and temporary stay granted to family members of an intra-corporate transferee under Article 19 of Directive 2014/66/EU of the European Parliament and of the Council (2). 4. The United Kingdom shall allow the entry and temporary stay of partners and dependent children of intra-corporate transferees, as allowed under the United Kingdom's Immigration Rules. 5. The United Kingdom shall allow the partners and dependent children of intra-corporate transferees referred to in paragraph 4 to work for the duration of their visa, in an employed or self-employed capacity, and shall not require them to obtain a work permit. (1) Paragraphs 1, 2 and 3 do not apply to the Member States that are not subject to the application of Directive 2014/66/EU of the European Parliament and of the Council of 15 May 2014 on the conditions of entry and residence of third-country nationals in the framework of an intra- corporate transfer (OJ EU L 157, 27.5.2014, p. 1) (the "ICT Directive"). (2) Directive 2014/66/EU of the European Parliament and of the Council of 15 May 2014 on the conditions of entry and residence of third- country nationals in the framework of an intra-corporate transfer (OJ EU L 157, 27.5.2014, p. 1). ANNEX 24 GUIDELINES FOR ARRANGEMENTS ON THE RECOGNITION OF PROFESSIONAL QUALIFICATIONS SECTION A GENERAL PROVISIONS Introduction 1. This Annex contains guidelines for arrangements on the conditions for the recognition of professional qualifications ("arrangements"), as foreseen by Article 158 of this Agreement. 2. Pursuant to Article 158 of this Agreement, these guidelines shall be taken into account in the development of joint recommendations by professional bodies or authorities of the Parties ("joint recommendations"). 3. The guidelines are non-binding, non-exhaustive and do not modify or affect the rights and obligations of the Parties under this Agreement. They set out the typical content of arrangements, and provide general indications as to the economic value of an arrangement and the compatibility of the respective professional qualifications regimes. 4. Not all elements of these guidelines may be relevant in all cases and professional bodies and authorities are free to include in their joint recommendations any other element that they consider pertinent for the arrangements of the profession and the professional activities concerned, consistent with this Agreement. 5. The guidelines should be taken into account by the Partnership Council when deciding whether to develop and adopt arrangements. They are without prejudice to its review of the consistency of joint recommendations with Title II of Heading One of Part Two of this Agreement and its discretion to take into account the elements it deems relevant, including those contained in joint recommendations. SECTION B FORM AND CONTENT OF AN ARRANGEMENT 6. This section sets out the typical content of an arrangement, some of which is not within the remit of the professional bodies or authorities preparing joint recommendations. These aspects constitute, nonetheless, useful information to be taken into account in the preparation of joint recommendations, so that they are better adapted to the possible scope of an arrangement. 7. Matters addressed specifically in this Agreement which apply to arrangements (such as the geographical scope of an arrangement, its interaction with scheduled non-conforming measures, the system of dispute resolution, appeal mechanisms, monitoring and review mechanisms of the arrangement) should not be addressed by joint recommendations. 8. An arrangement may specify different mechanisms for the recognition of professional qualifications within a Party. It may also be limited, but not necessarily so, to setting the scope of the arrangement, the procedural provisions, the effects of recognition and additional requirements, and the administrative arrangements. 9. An arrangement which is adopted by the Partnership Council should reflect the degree of discretion that is intended to be preserved for competent authorities deciding on recognition. Scope of an Arrangement 10. The arrangement should set out: (a) the specific regulated profession(s), relevant professional title(s) and the activity or group of activities covered by the scope of practice of the regulated profession in both Parties ("scope of practice"); and (b) whether it covers the recognition of professional qualifications for the purpose of access to professional activities on a fixed-term or an indefinite basis. Conditions for recognition 11. The arrangement may specify in particular: (a) the professional qualifications necessary for recognition under the arrangement (for example, evidence of formal qualification, professional experience, or other attestation of competence); (b) the degree of discretion preserved by recognition authorities when assessing requests for recognition of these qualifications; and (c) the procedures to deal with variations and gaps between professional qualifications and means to bridge the differences, including the possibility for imposing any compensatory measures or any other relevant conditions and limitations. Procedural provisions 12. The arrangement may set out: (a) the documents required and the form in which they should be presented (for example, by electronic or other means, whether they should be supported by translations or certifications of authenticity, etc.); (b) the steps and procedures in the recognition process, including those relating to possible compensatory measures, corresponding obligations and timelines; and (c) the availability of information relevant to all aspects of the recognition processes and requirements. Effects of recognition and additional requirements 13. The arrangement may set out provisions on the effects of recognition (if relevant, also in respect of different modes of supply). 14. The arrangement may describe any additional requirements for the effective exercise of the regulated profession in the host Party. Such requirements may include: (a) registration requirements with local authorities; (b) appropriate language skills; (c) proof of good character; (d) compliance with the requirements of the host Party for use of trade or firm names; (e) compliance with the rules of ethics, independence and professional conduct requirements of the host Party; (f) need to obtain professional indemnity insurance; (g) rules on disciplinary action, financial responsibility and professional liability; and (h) requirements for continuous professional development. Administration of the arrangement 15. The arrangement should set out the terms under which it can be reviewed or revoked, and the effects of any revision or revocation. Consideration may also be given to the inclusion of provisions concerning the effects of any recognition previously accorded. SECTION C ECONOMIC VALUE OF AN ENVISAGED ARRANGEMENT 16. Pursuant to Article 158(2) of this Agreement, joint recommendations shall be supported by an evidence-based assessment of the economic value of an envisaged arrangement. This may consist of an evaluation of the economic benefits that an arrangement is expected to bring to the economies of both Parties. Such an assessment may assist the Partnership Council when developing and adopting an arrangement. 17. Aspects such as the existing level of market openness, industry needs, market trends and developments, client expectations and requirements and business opportunities would constitute useful elements. 18. The evaluation is not required to be a full and detailed economic analysis, but should provide an explanation of the interest of the profession in, and the expected benefits for the Parties ensuing from, the adoption of an arrangement. SECTION D COMPATIBILITY OF RESPECTIVE PROFESSIONAL QUALIFICATION REGIMES 19. Pursuant to Article 158(2) of this Agreement, joint recommendations shall be supported by an evidence-based assessment of the compatibility of the respective professional qualification regimes. This assessment may assist the Partnership Council when developing and adopting an arrangement. 20. The following process aims at guiding professional bodies and authorities when assessing the compatibility of the respective professional qualifications and activities with a view to simplifying and facilitating the recognition of professional qualifications. Step One: Assessment of the scope of practice and the professional qualifications required to practise the regulated profession in each Party. 21. The assessment of the scope of practice and of the professional qualifications required to practise a regulated profession in each of the Parties should be based on all relevant information. 22. The following elements should be identified: (a) activities or groups of activities covered by the scope of practice of the regulated profession in each Party; and (b) the professional qualifications required in each Party to practise the regulated profession, which may include any of the following elements: (i) the minimum education required, for example, entry requirements, level of education, length of study and contents of study; (ii) the minimum professional experience required, for example, location, length and conditions of practical training or supervised professional practice prior to registration, licensing or equivalent; (iii) examinations passed, especially examinations of professional competency; and (iv) the acquisition of a licence, or equivalent, certifying, inter alia, the fulfilment of the necessary professional qualification requirements for the pursuit of the profession. Step Two: Evaluation of the divergence between the scope of practice of, or the professional qualifications required to practise, the regulated profession in each Party. 23. The evaluation of the divergence in the scope of practice of, or in the professional qualifications required to practise, the regulated profession, in each Party, should in particular identify divergence that is substantial. 24. Substantial divergence in the scope of practice may exist if all of the following conditions are met: (a) one or more activities covered by a regulated profession in the host Party are not covered by the corresponding profession in the Party of origin; (b) such activities are subject to specific training in the host Party; (c) the training for such activities in the host Party covers matters substantially diverging from those covered by the applicant's qualification. 25. Substantial divergence in the professional qualifications required to practise a regulated profession may exist if there are divergences in the Parties' requirements with regard to the level, duration or content of the training that is required for the pursuit of activities covered by the regulated profession. Step Three: Recognition mechanisms 26. There may be different mechanisms for the recognition of professional qualifications, depending on the circumstances. There may be different mechanisms within a Party. 27. If there is no substantial divergence in the scope of practice and in the professional qualifications required to practise a regulated profession, an arrangement may provide for a simpler, more streamlined recognition process than would be the case where substantial divergence exists. 28. If there is substantial divergence, the arrangement may provide for compensatory measures which are sufficient to remedy such divergence. 29. Where compensatory measures are used to reduce substantial divergence, they should be proportionate to the divergence that they seek to address. Any practical professional experience or formally validated training could be taken into account to assess the extent of the compensatory measures needed. 30. Whether or not the divergence is substantial, the arrangement may take account of the degree of discretion that is intended to be preserved for competent authorities deciding on recognition requests. 31. Compensatory measures may take different forms, including: (a) a period of supervised practice of a regulated profession in the host Party, possibly accompanied by further training, under the responsibility of a qualified person and subject to a regulated assessment; (b) a test made or recognised by the relevant authorities of the host Party to assess the applicant's ability to practice a regulated profession in that Party; or (c) a temporary limitation of the scope of practice; or a combination of those. 32. The arrangement could envisage that a choice be given to applicants between different compensatory measures where this could limit the administrative burden for applicants and such measures are equivalent. ANNEX 25 PUBLIC PROCUREMENT SECTION A RELEVANT PROVISIONS OF THE GPA Articles I to III, IV.1.a, IV.2 to IV.7, VI to XV, XVI.1 to XVI.3, XVII and XVIII. SECTION B: MARKET ACCESS COMMITMENTS For the purposes of this Section, "CPC" means the Provisional Central Product Classification (Statistical Papers, Series M No. 77, Department of International Economic and Social Affairs, Statistical Office of the United Nations, New York, 1991). SUB-SECTION B1 European Union In accordance with Article 277(2) and (3) of this Agreement, Title VI of Heading One of Part Two of this Agreement applies, in addition to the procurement covered by the annexes of the European Union to Appendix I to the GPA, to the procurement covered by this Sub-section. The Notes in Annexes 1 to 7 of the European Union to Appendix I to the GPA also apply to the procurement covered by this Sub-section, unless otherwise provided for in this Sub-section. Procurement covered by this Sub-section 1. Additional procuring entities Procurement of goods and services as set out in Annexes 4 to 6 of the European Union to Appendix I to the GPA, and in paragraph 2 of this Sub-section, by the following procuring entities of the Member States: (a) all contracting entities whose procurement is covered by Directive 2014/25/EU of the European Parliament and of the Council (1) (the "EU Utilities Directive") which are contracting authorities (e.g. those covered under Annex 1 and Annex 2 to Appendix I to the GPA) or public undertakings (2) and which have as one of their activities: (i) the provision or operation of fixed networks intended to provide a service to the public in connection with the production, transport or distribution of gas or heat or the supply of gas or heat to such networks; or (ii) any combination between such activity and those referred to in Annex 3 to Appendix I to the GPA; (b) privately-owned procuring entities that have as one of their activities any of those referred to in point (a) of this paragraph, in point 1 of Annex 3 to Appendix I to the GPA, or any combination thereof and operate on the basis of special or exclusive rights granted by a competent authority of a Member State; with regard to procurement equal to or above the following thresholds: — 400 000 SDR for procurement of goods and services, — 5 000 000 SDR for procurement of construction services (CPC 51). 2. Additional services Procurement of the following services, in addition to the services listed under Annex 5 of the European Union to Appendix I to the GPA, for entities covered under Annexes 1 to 3 of the European Union to Appendix I to the GPA or under paragraph 1 of this Sub-section: — Hotel and restaurant services (CPC 641); — Food serving services (CPC 642); — Beverage serving services (CPC 643); — Telecommunication related services (CPC 754); — Real estate services on a fee or contract basis (CPC 8220); — Other business services (CPC 87901, 87903, 87905-87907); — Education services (CPC 92). Notes: 1. Hotel and restaurant services (CPC 641), food serving services (CPC 642), beverage serving services (CPC 643) and education services (CPC 92) contracts are included under the national treatment regime for the suppliers, including service providers, of the United Kingdom, provided that their value equals or exceeds EUR 750 000 when they are awarded by procuring entities covered under Annexes 1 and 2 of the European Union to Appendix I to the GPA and that their value equals or exceeds EUR 1 000 000 when they are awarded by procuring entities covered under Annex 3 of the European Union to Appendix I to the GPA or by procuring entities covered by paragraph 1 of this Sub-section. 2. The supply of gas or heat to networks which provide a service to the public by a procuring entity other than a contracting authority shall not be considered as an activity within the meaning of this Sub-section where: (a) the production of gas or heat by the entity concerned takes place because its consumption is necessary for carrying out an activity other than that referred to in this Sub-section or in paragraphs (a) to (f) of Annex 3 of the European Union to Appendix I to the GPA; and (b) the supply to the public network is aimed only at the economic exploitation of such production and amounts to not more than 20 % of the entity's turnover on the basis of the average for the preceding three years, including the current year. 3. Title VI of Heading One of Part Two of this Agreement and this Annex do not cover procurement of the following services: (a) Human health services (CPC 931); (b) Administrative healthcare services (CPC 91122); and (c) Supply services of nursing personnel and supply services of medical personnel (CPC 87206 and CPC 87209). SUB-SECTION B2 United Kingdom In accordance with Article 277 (2) and (3) of this Agreement, Title VI of Heading One of Part Two of this Agreement applies, in addition to the procurement covered by Article II of the GPA, to the procurement covered by this Sub-section. The Notes in Annexes 1 to 7 of the United Kingdom to Appendix I to the GPA also apply to the procurement covered by this Sub-section, unless otherwise provided for in this Sub-section. Procurement covered by this Sub-section 1. Additional procuring entities Procurement of goods and services as set out in Annexes 4 to 6 of the United Kingdom's Appendix I to the GPA, and in paragraph 2 of this Sub-section, by the following procuring entities of the United Kingdom: (a) all contracting entities whose procurement is covered by the Utilities Contracts Regulation 2016 and the Utilities Contracts (Scotland) Regulations 2016 which are contracting authorities (e.g. those covered under Annex 1 and Annex 2 to Appendix I to the GPA) or public undertakings (see Note:1) and which have as one of their activities: (i) the provision or operation of fixed networks intended to provide a service to the public in connection with the production, transport or distribution of gas or heat or the supply of gas or heat to such networks; or (ii) any combination between such activity and those referred to in Annex 3 to Appendix I to the GPA; (b) privately-owned procuring entities that have as one of their activities any of those referred to in point (a) of this paragraph, in point 1 of Annex 3 to Appendix I to the GPA, or any combination thereof and operate on the basis of special or exclusive rights granted by a competent authority of the United Kingdom; with regard to procurement equal to or above the following thresholds: — 400 000 SDR for procurement of goods and services, — 5 000 000 SDR for procurement of construction services (CPC 51). Notes to paragraph 1: 1. According to the Utilities Contracts Regulations 2016, a "public undertaking" means any undertaking over which contracting authorities may exercise directly or indirectly a dominant influence by virtue of: (a) their ownership of that undertaking; (b) their financial participation in that undertaking; or (c) the rules which govern that undertaking. 2. According to the Utilities Contracts (Scotland) Regulations 2016, a "public undertaking" means a person over which one or more contracting authorities are able to exercise, directly or indirectly, a dominant influence by virtue of one or more of the following: (a) their ownership of that person; (b) their financial participation in that person; (c) the rights accorded to them by the rules which govern that person. 3. According to both the Utilities Contracts Regulations 2016 and the Utilities Contracts (Scotland) Regulations 2016, a dominant influence on the part of contracting authorities is presumed in any of the following cases in which those authorities, directly or indirectly: (a) hold the majority of the undertaking's subscribed capital; (b) control the majority of the votes attaching to shares issued by the undertaking; (c) can appoint more than half of the undertaking's administrative, management or supervisory body. 2. Additional services Procurement of the following services, in addition to the services listed under Annex 5 of the United Kingdom to Appendix I to the GPA, for entities covered under Annexes 1 to 3 of the United Kingdom to Appendix I to the GPA or under paragraph 1 of this Sub-section: — Hotel and restaurant services (CPC 641); — Food serving services (CPC 642); — Beverage serving services (CPC 643); — Telecommunication related services (CPC 754); — Real estate services on a fee or contract basis (CPC 8220); — Other business services (CPC 87901, 87903, 87905-87907); — Education services (CPC 92). Notes: 1. Hotel and restaurant services (CPC 641), food serving services (CPC 642), beverage serving services (CPC 643) and education services (CPC 92) contracts are included under the national treatment regime for the suppliers, including service providers, of the European Union, provided that their value equals or exceeds GBP 663 540 when they are awarded by procuring entities covered under Annexes 1 and 2 of the United Kingdom to Appendix I to the GPA and that their value equals or exceeds GBP 884 720 when they are awarded by procuring entities covered under Annex 3 of the United Kingdom to Appendix I to the GPA or by procuring entities covered by paragraph 1 of this Section. 2. The supply of gas or heat to networks which provide a service to the public by a procuring entity other than a contracting authority shall not be considered as an activity within the meaning of this Section where: (a) the production of gas or heat by the entity concerned takes place because its consumption is necessary for carrying out an activity other than that referred to in this Section or in paragraphs (a) to (f) of Annex 3 of the United Kingdom to Appendix I to the GPA; and (b) the supply to the public network is aimed only at the economic exploitation of such production and amounts to not more than 20 % of the entity's turnover on the basis of the average for the preceding three years, including the current year. 3. Title VI of Heading One of Part Two of this Agreement and this Annex do not cover procurement of the following services: (a) Human health services (CPC 931); (b) Administrative healthcare services (CPC 91122); and (c) Supply services of nursing personnel and supply services of medical personnel (CPC 87206 and CPC 87209). (1) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ EU L 94 28.3.2014, p. 243). (2) According to the EU Utilities Directive, a public undertaking is any undertaking over which the contracting authorities may exercise directly or indirectly a dominant influence by virtue of their ownership of it, their financial participation therein, or the rules which govern it. A dominant influence on the part of the contracting authorities shall be presumed when these authorities, directly or indirectly, in relation to an undertaking: (i) hold the majority of the undertaking's subscribed capital, (ii) control the majority of the votes attaching to shares issued by the undertaking, or (iii) can appoint more than half of the undertaking's administrative, management or supervisory body. ANNEX 26 LISTS OF ENERGY GOODS, HYDROCARBONS AND RAW MATERIALS LIST OF ENERGY GOODS BY HS CODE — Natural gas, including liquefied natural gas, liquefied petroleum gas (LPG) (HS code 27.11) — Electrical energy (HS code 27.16) — Crude oil and oil products (HS code 27.09 - 27.10, 27.13-27.15) — Solid fuels (HS code 27.01, HS code 27.02, HS code 27.04) — Fuel wood and wood charcoal (HS code 44.01 and HS code 44.02 goods used for energy) — Biogas (HS code 38.25) LIST OF HYDROCARBONS BY HS CODE — Crude oil (HS code 27.09) — Natural gas (HS code 27.11) LIST OF RAW MATERIALS BY HS CHAPTER Chapter Heading 25 Salt; sulphur; earths and stone; plastering materials, lime and cement 26 Ores, slag and ash, with the exception of uranium or thorium ores or concentrates (HS code 26.12) 27 Mineral fuels, mineral oils and products of their distillation; bituminous substances; mineral waxes 28 Inorganic chemicals; organic or inorganic compounds of precious metals, of rare-earth metals; of radioactive elements or of isotopes, with the exception of radioactive chemical elements and radioactive isotopes (including the fissile or fertile chemical elements and isotopes) and their compounds; mixtures and residues containing these products (HS code 28.44); and isotopes other than those of heading no. 28.44; compounds, inorganic or organic, of such isotopes, whether or not chemically defined (HS code 28.45) 29 Organic chemicals 31 Fertilisers 71 Natural or cultured pearls, precious or semi-precious stones, precious metals, metals clad with precious metal, and articles thereof, with the exception of pearls, natural or cultured, whether or not worked or graded but not strung, mounted or set; pearls, natural or cultured, temporarily strung for the convenience of transport (HS code 7101) 72 Iron and steel 74 Copper and articles thereof 75 Nickel and articles thereof 76 Aluminium and articles thereof 78 Lead and articles thereof 79 Zinc and articles thereof 80 Tin and articles thereof 81 Other base metals; cermets; articles thereof ANNEX 27 ENERGY AND ENVIRONMENTAL SUBSIDIES As part of the principles set out in Article 367(14) of this Agreement: (1) Subsidies for electricity generation adequacy, renewable energy and cogeneration shall not undermine the ability of a Party to meet its obligations under Article 304 of this Agreement, shall not unnecessarily affect the efficient use of electricity interconnectors provided for under Article 311 of this Agreement, and, without prejudice to Article 304(3) of this Agreement, shall be determined by means of a transparent, non-discriminatory and effective competitive process; and (a) subsidies for electricity generation adequacy shall provide incentives for capacity providers to be available in times of expected system stress and may be limited to installations not exceeding specified CO2 emission limits; and (b) subsidies for renewable energy and cogeneration shall not affect beneficiaries’ obligations or opportunities to participate in electricity markets. (2) Notwithstanding point 1, provided that appropriate measures are put in place to prevent overcompensation, non-competitive procedures may be used to grant subsidies for renewable energy and cogeneration if the potential supply is insufficient to ensure a competitive process, the eligible capacity is unlikely to have a material effect on trade or investment between the Parties, or subsidies are granted for demonstration projects. (3) If partial exemptions from energy-related taxes and levies (1) in favour of energy-intensive users are introduced, such exemptions shall not exceed the total amount of the tax or levy. (4) If compensation for electricity-intensive users is granted in the event of an increase in electricity cost resulting from climate policy instruments, it shall be restricted to sectors at significant risk of carbon leakage due to the cost increase. (5) Subsidies for the decarbonisation of emissions linked to own industrial activities shall achieve an overall reduction in greenhouse gas emissions. The subsidies shall reduce the emissions directly resulting from the industrial activity. Subsidies for improvements of the energy efficiency of own industrial activities shall improve energy efficiency by reducing energy consumption, either directly or per unit of production. (1) For greater certainty, levies do not include network charges or tariffs. ANNEX 28 NON-APPLICATION OF THIRD-PARTY ACCESS AND OWNERSHIP UNBUNDLING TO INFRASTRUCTURE A Party may decide not to apply Articles 306 and 307 of this Agreement to new infrastructure or to a significant expansion of existing infrastructure where: (a) the risk attached to the investment in the infrastructure is such that the investment would not take place unless an exemption is granted; (b) the investment enhances competition or security of supply; (c) the infrastructure is owned by a natural or legal person separate, at least in terms of its legal form, from the system operators in whose systems it was or is to be built; (d) before granting the exemption, the Party has decided on the rules and mechanisms for management and allocation of capacity. ANNEX 29 ALLOCATION OF ELECTRICITY INTERCONNECTOR CAPACITY AT THE DAY-AHEAD MARKET TIMEFRAME PART 1 1. The new procedure for the allocation of capacity on electricity interconnectors at the day-ahead market timeframe shall be based on the concept of "Multi-region loose volume coupling". The overall objective of the new procedure shall be to maximise the benefits of trade. As the first step in developing the new procedure, the Parties shall ensure that transmission system operators prepare outline proposals and a cost-benefit analysis. 2. Multi-region loose volume coupling shall involve the development of a market coupling function to determine the net energy positions (implicit allocation) between: (a) bidding zones established in accordance with Regulation (EU) 2019/943, which are directly connected to the United Kingdom by an electricity interconnector; and (b) the United Kingdom. 3. The net energy positions over electricity interconnectors shall be calculated via an implicit allocation process by applying a specific algorithm to: (a) commercial bids and offers for the day-ahead market timeframe from the bidding zones established in accordance with Regulation (EU) 2019/943 which are directly connected to the United Kingdom by an electricity interconnector; (b) commercial bids and offers for the day-ahead market timeframe from relevant day-ahead markets in the United Kingdom; (c) network capacity data and system capabilities determined in accordance with the procedures agreed between transmission system operators; and (d) data on expected commercial flows of electricity interconnections between bidding zones connected to the United Kingdom and other bidding zones in the Union, as determined by Union transmission system operators using robust methodologies. This process shall be compatible with the specific characteristics of direct current electricity interconnectors, including losses and ramping requirements. 4. The market coupling function shall: (a) produce results sufficiently in advance of the operation of the Parties' respective day-ahead markets (for the Union this is single day-ahead coupling established in accordance with Commission Regulation (EU) 2015/1222 (1)) in order that such results may be used as inputs into the processes which determine the results in those markets; (b) produce results which are reliable and repeatable; (c) be a specific process to link the distinct and separate day-ahead markets in the Union and the United Kingdom; in particular, this means that the specific algorithm shall be distinct and separate from that used in single day-ahead coupling established in accordance with Regulation (EU) 2015/1222 and, in respect of commercial bids and offers of the Union, only have access to those from bidding zones which are directly connected to the United Kingdom by an electricity interconnector. 5. The calculated net energy positions shall be published following validation and verification. If the market coupling function is unable either to operate or to produce a result, electricity interconnector capacity shall be allocated by a fall-back process, and market participants shall be notified that the fall-back process will apply. 6. The costs of developing and implementing the technical procedures shall be equally shared between the relevant United Kingdom transmission system operators or other entities, on the one side, and relevant Union transmission system operators or other entities, on the other side, unless the Specialised Committee on Energy decides otherwise. PART 2 The timeline for the implementation of this Annex shall be from the entry into force of this Agreement, as follows: (a) within 3 months – cost benefit analysis and outline of proposals for technical procedures; (b) within 10 months – proposal for technical procedures; (c) within 15 months – entry into operation of technical procedures. (1) Commission Regulation (EU) 2015/1222 of 24 July 2015 establishing a guideline on capacity allocation and congestion management (OJ EU L 197, 25.7.2015, p. 24). ANNEX 30 AIRWORTHINESS AND ENVIRONMENT CERTIFICATION SECTION A GENERAL PROVISIONS Article 1 Purpose and scope 1. The objective of this Annex is the implementation of cooperation in the following areas, in accordance with Article 445(2) of this Agreement, describing the terms, conditions and methods for reciprocal acceptance of findings of compliance and certificates: (a) airworthiness certificates and monitoring of civil aeronautical products referred to in point (a) of Article 445(1) of this Agreement; (b) environmental certificates and testing of civil aeronautical products referred to in point (b) of Article 445(1) of this Agreement; and (c) design and production certificates and monitoring of design and production organisations referred to in point (c) Article 445(1) of this Agreement. 2. Notwithstanding paragraph 1, used civil aeronautical products, other than used aircraft, are excluded from the scope of this Annex. Article 2 Definitions For the purposes of this Annex, the following definitions apply: (a) "acceptance" means the recognition of certificates, approvals, changes, repairs, documents and data of one Party by the other Party without validation activities and without issuing a corresponding certificate by that other Party; (b) "authorised release certificate" means a certificate issued by an approved organisation or a competent authority of the exporting Party as a form of recognition that a new civil aeronautical product, other than an aircraft, conforms to a design approved by the exporting Party and is in a condition for safe operation; (c) "category of civil aeronautical products" means a set of products sharing common characteristics, as grouped in the technical implementation procedures, on the basis of EASA and UK CAA Certification Specifications; (d) "certificating authority" means the technical agent of the exporting Party that issues a design certificate for a civil aeronautical product in its capacity as an authority carrying out the State of Design responsibilities set out in Annex 8 to the Convention on International Civil Aviation. When a design certificate is issued by an approved organisation of the exporting Party, the technical agent of the exporting Party is considered as the certificating authority; (e) "design certificate" means a form of recognition by the technical agent or an approved organisation of a Party that the design or change to a design of a civil aeronautical product complies with airworthiness requirements, as applicable, and environmental protection requirements, in particular concerning environmental characteristics set out in laws, regulations and administrative provisions of that Party; (f) "design-related operational requirements" means the operational, including environmental, requirements affecting either the design features of the civil aeronautical product or data on the design relating to the operations, or the maintenance of that product, which make it eligible for a particular kind of operation; (g) "export" means the process by which a civil aeronautical product is released from the regulatory system for civil aviation safety of a Party to that of the other Party; (h) "export certificate of airworthiness" means a certificate issued by the competent authority of the exporting Party or, for used aircraft, by the competent authority of the State of Registry from which the product is exported as a form of recognition that an aircraft conforms to the applicable airworthiness and environmental protection requirements notified by the importing Party; (i) "exporting Party" means the Party from whose regulatory system for civil aviation safety a civil aeronautical product is released; (j) "import" means the process by which an exported civil aeronautical product from the regulatory system for civil aviation safety of a Party is introduced into that of the other Party; (k) "importing Party" means the Party into whose regulatory system for civil aviation safety a civil aeronautical product is introduced; (l) "major change" means all changes in type design other than "minor change"; (m) "minor change" means a change in type design that has no appreciable effect on the mass, balance, structural strength, reliability, operational characteristics, environmental characteristics, or other characteristics affecting the airworthiness of the civil aeronautical product; (n) "operational suitability data" means the required set of data to support and allow the type specific operational aspects of certain types of aircraft that are regulated under the regulatory system for civil aviation safety of the Union or of the United Kingdom. It must be designed by the type certificate applicant or holder for the aircraft and be part of the type certificate. Under the regulatory system for civil aviation safety of the Union or of the United Kingdom, an initial application for a type certificate or restricted type certificate shall include, or be subsequently supplemented by, the application for approval of operational suitability data, as applicable to the aircraft type; (o) "production approval" means a certificate issued by the competent authority of a Party to a manufacturer which produces civil aeronautical products, as a form of recognition that the manufacturer complies with applicable requirements set out in laws, regulations and administrative provisions of that Party for the production of the particular civil aeronautical products; (p) "technical implementation procedures" means the implementation procedures for this Annex developed by the technical agents of the Parties in accordance with Article 445(5) of this Agreement; (q) "validating authority" means the technical agent of the importing Party that accepts or validates, as specified in this Annex, a design certificate issued by the certificating authority. SECTION B CERTIFICATION OVERSIGHT BOARD Article 3 Establishment and composition 1. The Certification Oversight Board, accountable to the Specialised Committee on Aviation Safety, is hereby established under the co-chairmanship of the technical agents of the Parties, as a technical coordination body responsible for the effective implementation of this Annex. It shall be composed of representatives from the technical agent of each Party and may invite additional participants to facilitate the fulfilment of its mandate. 2. The Certification Oversight Board shall meet at regular intervals upon the request of either technical agent, and take decisions and make recommendations by consensus. It shall develop and adopt its rules of procedure. Article 4 Mandate The mandate of the Certification Oversight Board shall include in particular: (a) developing, adopting, and revising the technical implementation procedures referred to in Article 6; (b) sharing information on major safety concerns and, where appropriate, developing action plans to address them; (c) resolving technical issues falling within the responsibilities of the competent authorities and affecting the implementation of this Annex; (d) where appropriate, developing effective means of cooperation, technical support and exchange of information regarding safety and environmental protection requirements, certification systems, and quality management and standardisation systems; (e) conducting periodic reviews on the modalities of validation or acceptance of design certificates set out in Articles 10 and 13; (f) proposing amendments to this Annex to the Specialised Committee on Aviation Safety; (g) in accordance with Article 29, defining procedures to ensure the continued confidence of each Party in the reliability of the other Party's processes for findings of compliance; (h) analysing and taking action regarding the implementation of the procedures referred to in point (g); and (i) reporting unresolved issues to the Specialised Committee on Aviation Safety and ensuring the implementation of decisions taken by the Specialised Committee on Aviation Safety regarding this Annex. SECTION C IMPLEMENTATION Article 5 Competent authorities for design certification, production certification and export Certificates 1. The competent authorities for design certification are: (a) for the Union: the European Union Aviation Safety Agency; and (b) for the United Kingdom: the Civil Aviation Authority of the United Kingdom. 2. The competent authorities for production certification and export certificates are: (a) for the Union: the European Union Aviation Safety Agency and the competent authorities of the Member States. As regards an export certificate for used aircraft, it is the competent authority of the State of Registry for the aircraft from which the aircraft is exported; and (b) for the United Kingdom: the Civil Aviation Authority of the United Kingdom. Article 6 Technical implementation procedures 1. The technical implementation procedures shall be developed by the technical agents of the Parties through the Certification Oversight Board in order to provide specific procedures to facilitate the implementation of this Annex, by defining the procedures for communication activities between the competent authorities of the Parties. 2. The technical implementation procedures shall also address the differences between the Parties' civil aviation standards, rules, practices, procedures and systems related to the implementation of this Annex, as provided for in Article 445(5) of this Agreement. Article 7 Exchange and protection of confidential and proprietary data and information 1. Data and information exchanged in the implementation of this Annex shall be subject to Article 453 of this Agreement. 2. Data and information exchanged during the validation process shall be limited in nature and content to what is necessary for the purpose of compliance demonstration with applicable technical requirements, as detailed in the technical implementation procedures. 3. Any disagreement with regard to a data and information exchange between the competent authorities shall be handled as detailed in the technical implementation procedures. Each Party shall retain the right to refer the disagreement to the Certification Oversight Board for resolution. SECTION D DESIGN CERTIFICATION Article 8 General principles 1. This Section addresses all design certificates and changes thereto, where applicable, within the scope of this Annex, in particular: (a) type certificates, including restricted type certificates; (b) supplemental type certificates; (c) repair design approvals; and (d) technical standard order authorisations. 2. The validating authority shall either validate, having regard to the level of involvement referred to in Article 12, or accept a design certificate or a change that has been, or is in the process of being, issued or approved by the certificating authority, in accordance with the terms and conditions set out in this Annex and as detailed in the technical implementation procedures, including its modalities of acceptance and validation of certificates. 3. For the implementation of this Annex, each Party shall ensure that, in its regulatory system for civil aviation safety, the capability of any design organisation to assume its responsibilities is sufficiently controlled through a system of certification for design organisations. Article 9 Validation process 1. An application for the validation of a design certificate of a civil aeronautical product shall be made to the validating authority through the certificating authority as detailed in the technical implementation procedures. 2. The certificating authority shall ensure that the validating authority receives all the relevant data and information necessary for the validation of the design certificate, as detailed in the technical implementation procedures. 3. Upon receiving the application for the validation of the design certificate, the validating authority shall determine the certification basis for the validation in accordance with Article 11, as well as the level of involvement of the validating authority in the validation process in accordance with Article 12. 4. The validating authority shall, as detailed in the technical implementation procedures, base its validation to the maximum extent practicable on the technical evaluations, tests, inspections, and findings of compliance made by the certificating authority. 5. The validating authority shall, after examining relevant data and information provided by the certificating authority, issue its design certificate for the validated civil aeronautical product ("validated design certificate") when: (a) it is confirmed that the certificating authority has issued its own design certificate for the civil aeronautical product; (b) it has been stated by the certificating authority that the civil aeronautical product complies with the certification basis referred to in Article 11; (c) all issues raised during the validation process conducted by the validating authority have been resolved; and (d) additional administrative requirements, as detailed in the technical implementation procedures, have been met by the applicant. 6. Each Party shall ensure that in order to obtain and maintain a validated design certificate, the applicant holds and retains at the disposal of the certificating authority all relevant design information, drawings and test reports, including inspection records for the certified civil aeronautical product, in order to provide the information necessary to ensure the continued airworthiness and compliance with applicable environmental protection requirements of the civil aeronautical product. Article 10 Modalities of the validation of design certificates 1. Type certificates issued by the technical agent of the Union as certificating authority shall be validated by the technical agent of the United Kingdom as validating authority. The following data shall be subject to acceptance: (a) engine installation manual (for engine type certificate); (b) structural repair manual; (c) instruction for continued airworthiness of electrical wiring interconnection systems; and (d) weight balance manual. By way of technical implementation procedures, procedural detail may be established in respect of acceptance of the relevant data. Any such procedural detail must not affect the requirement of acceptance established in the first subparagraph. 2. Significant supplemental type certificates and approvals for significant major changes issued by the technical agent of the Union as certificating authority shall be validated by the technical agent of the United Kingdom as validating authority. A streamlined validation process limited to the technical familiarisation without the involvement of the validating authority in the showing of compliance activities by the applicant shall be used as a matter of principle, unless otherwise decided by the technical agents on a case-by-case basis. 3. Type certificates issued by the technical agent of the United Kingdom as certificating authority shall be validated by the technical agent of the Union as validating authority. 4. Supplemental type certificates, approvals for major changes, major repairs and technical standard order authorisations issued by the technical agent of the United Kingdom as certificating authority or by an approved organisation under laws and regulations of the United Kingdom shall be validated by the technical agent of the Union as validating authority. A streamlined validation process limited to the technical familiarisation without the involvement of the validating authority in the showing of compliance activities by the applicant may be used when decided by the technical agents on a case-by-case basis. Article 11 Certification basis for the validation 1. For the purpose of validating a design certificate of a civil aeronautical product, the validating authority shall refer to the following requirements set out in laws, regulations and administrative provisions of its Party in determining the certification basis: (a) the airworthiness requirements for a similar civil aeronautical product that were in effect on the effective application date established by the certificating authority, and complemented when applicable by additional technical conditions as detailed in the technical implementation procedures; and (b) the environmental protection requirements for the civil aeronautical product that were in effect on the date of the application for the validation to the validating authority. 2. The validating authority shall specify, when applicable, any: (a) exemption to the applicable requirements; (b) deviation from the applicable requirements; or (c) compensating factors that provide an equivalent level of safety when applicable requirements are not complied with. 3. In addition to the requirements set out in paragraphs 1 and 2, the validating authority shall specify any special condition to be applied if the related airworthiness codes, laws, regulations and administrative provisions do not contain adequate or appropriate safety requirements for the civil aeronautical product, because: (a) the civil aeronautical product has novel or unusual design features relative to the design practices on which the applicable airworthiness codes, laws, regulations and administrative provisions are based; (b) the intended use of the civil aeronautical product is unconventional; or (c) experience obtained from other, similar civil aeronautical products in service or civil aeronautical products having similar design features has shown that unsafe conditions may develop. 4. When specifying exemptions, deviations, compensating factors or special conditions, the validating authority shall give due consideration to these applied by the certificating authority and they shall not be more demanding for the civil aeronautical products to be validated than they would be for its own similar products. The validating authority shall notify the certificating authority of any such exemptions, deviations, compensating factors or special conditions. Article 12 Level of involvement of the validating authority 1. The level of involvement of the validating authority of a Party during the validation process referred to in Article 9 and as detailed in the technical implementation procedures, shall be mainly determined by: (a) the experience and records of the competent authority of the other Party as certificating authority; (b) the experience already gained by that validating authority during previous validation exercises with the competent authority of the other Party; (c) the nature of the design to be validated; (d) the performance and experience of the applicant with the validating authority; and (e) the outcome of qualification requirements assessments referred to in Articles 28 and Article 29. 2. The validating authority shall exercise special procedures and scrutiny, in particular regarding the certificating authority's processes and methods, during the first validation of any certificate, where the certificating authority has not previously issued a certificate in the category of civil aeronautical products concerned after 30 September 2004. The procedures and criteria to be applied shall be detailed in the technical implementation procedures. 3. The effective implementation of the principles set out in paragraphs 1 and 2 shall be regularly measured, monitored, reviewed by the Certification Oversight Board, using metrics as detailed in the technical implementation procedures. Article 13 Acceptance 1. For a design certificate subject to acceptance, the validating authority shall accept the design certificate issued by the certificating authority without any validation activities. In that case, the design certificate shall be recognised by the validating authority as equivalent to a certificate issued in accordance with laws, regulations and administrative provisions of its Party and the validating authority shall not issue its corresponding certificate. 2. Non-significant supplemental type certificates, non-significant major changes and technical standard order authorisations issued by the technical agent of the Union as certificating authority or by an approved organisation under Union law shall be accepted by the technical agent of the United Kingdom as validating authority. 3. Minor changes and repairs approved by the technical agent of the Union as certificating authority or by an approved organisation under Union law shall be accepted by the technical agent of the United Kingdom as validating authority. 4. Minor changes and minor repairs approved by the technical agent of the United Kingdom as certificating authority or by an approved organisation under laws and regulations of the United Kingdom shall be accepted by the technical agent of the Union as validating authority. Article 14 Implementation provisions for Articles 10 and 13 1. The minor change or major change classifications shall be made by the certificating authority in accordance with the definitions set out in this Annex and interpreted in accordance with the applicable rules and procedures of the certificating authority. 2. For classifying a supplemental type certificate or major change as significant or non-significant, the certificating authority shall consider the change in the context of all previous relevant design changes and all related revisions to the applicable certification specifications incorporated in the type certificate for the civil aeronautical product. Changes that meet either of the following criteria are automatically considered as significant: (a) the general configuration or the principles of construction are not retained; or (b) the assumptions used for certification of the product to be changed do not remain valid. Article 15 Existing design certificates For the purposes of this Annex, the following apply: (a) type certificates, supplemental type certificates, approvals for changes and repairs, as well as technical standard order authorisations and changes thereto issued by the technical agent of the Union to United Kingdom applicants, or by an approved design organisation located in the United Kingdom, on the basis of Union law and valid on 31 December 2020 are deemed to have been issued by the technical agent of the United Kingdom as certificating authority or by an approved organisation under the laws and regulations of the United Kingdom and to have been accepted by the technical agent of the Union as validating authority in accordance with Article 13(1); (b) type certificates, supplemental type certificates, approvals for changes and repairs, as well as technical standard order authorisations and changes thereto issued by the technical agent of the Union to Union applicants, or by a design organisation located in the Union, on the basis of Union law and valid on 31 December 2020 are deemed to have been accepted by the technical agent of the United Kingdom as validating authority in accordance with Article 13(1). Article 16 Transfer of a design certificate In the event that a design certificate is transferred to another entity, the certificating authority responsible for the design certificate shall promptly notify the validating authority of the transfer and apply the procedure related to the transfer of design certificates as detailed in the technical implementation procedures. Article 17 Design-related operational requirements 1. The technical agents shall ensure that, where necessary, data and information related to design-related operational requirements shall be exchanged during the validation process. 2. Subject to decision by the technical agents for some design-related operational requirements, the validating authority may accept the compliance statement of the certificating authority through the validation process. Article 18 Operational documents and data related to the type 1. Some type-specific sets of operational documents and data, including operational suitability data in the Union system and the equivalent data in the United Kingdom system, provided by the type certificate holder shall be approved or accepted by the certificating authority and, where necessary, exchanged during the validation process. 2. Operational documents and data referred to in paragraph 1 may be either accepted or validated by the validating authority as detailed in the technical implementation procedures. Article 19 Concurrent validation When decided by the applicant and the technical agents, a concurrent certification and validation process may be used, where appropriate and as detailed in the technical implementation procedures. Article 20 Continuing airworthiness 1. The competent authorities shall take action to address unsafe conditions in civil aeronautical products for which they are the certificating authority. 2. Upon request, a competent authority of a Party shall, in respect of civil aeronautical products designed or manufactured under its regulatory system, assist the competent authority of the other Party in determining any action considered to be necessary for the continued airworthiness of the civil aeronautical products. 3. When in-service difficulties or other potential safety issues affecting a civil aeronautical product within the scope of this Annex lead to an investigation conducted by the technical agent of a Party that is the certificating authority for the civil aeronautical product, the technical agent of the other Party shall, upon request, support that investigation, including by providing relevant information reported by relevant entities on failures, malfunctions, defects or other occurrences affecting that civil aeronautical product. 4. The reporting obligations of the design certificate holders to the certificating authority and the information exchange mechanism established under this Annex shall be considered to fulfil the obligation of each design certificate holder to report failures, malfunctions, defects or other occurrences affecting that civil aeronautical product to the validating authority. 5. Actions to address unsafe conditions and exchange of safety information referred to in paragraphs 1 to 4 shall be detailed in the technical implementation procedures. 6. The technical agent of a Party shall keep the technical agent of the other Party informed of all its mandatory continuing airworthiness information in relation to civil aeronautical products designed or manufactured under its oversight system, and which are within the scope of this Annex. 7. Any changes to the airworthiness status of a certificate issued by a Party's technical agent shall be communicated in a timely manner to the other Party's technical agent. SECTION E PRODUCTION CERTIFICATION Article 21 Recognition of production certification and production oversight systems 1. The importing Party shall recognise the production certification and production oversight system of the exporting Party, since the system is considered sufficiently equivalent to the system of the importing Party within the scope of this Annex, subject to the provisions of this Article. 2. The recognition of the production certification and production oversight system of the United Kingdom by the Union is limited to the recognition of the production of categories of civil aeronautical products that were already subject to that system on 31 December 2020, as detailed in the technical implementation procedures. 3. In the event that a new category of civil aeronautical products is added to the exporting Party's production certification and production oversight system, the competent authority of the exporting Party shall notify the technical agent of the importing Party. Before extending the recognition of the production certification and production oversight system to the new category of civil aeronautical products, the technical agent of the importing Party may decide to conduct an assessment to confirm that the production certification and production oversight system of the exporting Party for this category of civil aeronautical products is sufficiently equivalent to the production certification and production oversight system of the importing Party. That assessment shall be performed as detailed in the technical implementation procedures, and may include an assessment of the production approval holder under the oversight of the competent authority of the exporting Party. The process for the extension of the recognition of the production certification and production oversight system of the exporting Party to the new category of civil aeronautical products by the importing Party shall be detailed in the technical implementation procedures. 4. The recognition of the production certification and production oversight system of the exporting Party by the importing Party shall be subject to the level of safety provided by the production certification and production oversight system of the exporting Party remaining sufficiently equivalent to that provided by the system of the importing Party. The equivalence of the production certification and production oversight system shall be continuously monitored through the procedures set out in Article 29. 5. Paragraphs 1 to 3 also apply to the production of a civil aeronautical product for which the State of Design responsibilities are exercised by a country other than the exporting Party of the civil aeronautical product, provided that the competent authority of the exporting Party has established and implemented the necessary procedures with the relevant authority of the State of Design to control the interface between the design certificate holder and the production approval holder for that civil aeronautical product. Article 22 Extension of production approval 1. A production approval issued by the competent authority of the exporting Party to a manufacturer primarily located in the territory of that exporting Party and recognised under Article 21(1) may be extended to include manufacturing sites and facilities of the manufacturer located in the territory of the other Party or in the territory of a third country, irrespective of the legal status of those manufacturing sites and facilities, and irrespective of the type of civil aeronautical product manufactured in those sites and facilities. In that case, the competent authority of the exporting Party shall remain responsible for the oversight of those manufacturing sites and facilities and the competent authority of the importing Party shall not issue its own production approval to these manufacturing sites and facilities for the same civil aeronautical product. 2. If facilities and manufacturing sites for a manufacturer primarily located in the territory of the exporting Party are located in the other Party, the competent authorities of both Parties shall cooperate with each other, in the framework of Article 32, with a view to having the importing Party participating in the oversight activities of the exporting Party in relation to these facilities. Article 23 Interface between the production approval holder and the design certificate holder 1. In cases where the production approval holder for a civil aeronautical product is regulated by the competent authority of a Party, and the design certificate holder for the same civil aeronautical product is regulated by the competent authority of the other Party, the competent authorities of the Parties shall establish procedures to define the responsibilities of each Party to control the interface between the production approval holder and the design certificate holder. 2. For the purpose of export of civil aeronautical products within the framework of this Annex, when the design certificate holder and the production approval holder are not the same legal entity, the competent authorities of the Parties shall ensure that the design certificate holder establishes proper arrangements with the production approval holder to ensure satisfactory coordination between design and production and the proper support of the continued airworthiness of the civil aeronautical product. SECTION F EXPORT CERTIFICATES Article 24 Forms The exporting Party's forms are: (a) when the exporting Party is the United Kingdom, CAA Form 52 for new aircraft, export certificate of airworthiness for used aircraft, and CAA Form 1 for other new products; and (b) when the exporting Party is the Union, EASA Form 52 for new aircraft, export certificate of airworthiness for used aircraft, and EASA Form 1 for other new products. Article 25 Issuance of an export certificate 1. When issuing an export certificate, the competent authority or production approval holder of the exporting Party shall ensure that such civil aeronautical product: (a) conforms to the design automatically accepted or validated, or certified by the importing Party in accordance with this Annex and as detailed in the technical implementation procedures; (b) is in a condition for safe operation; (c) meets all additional requirements notified by the importing Party; and (d) as regards civil aircraft, aircraft engines and aircraft propellers, complies with the applicable mandatory continuing airworthiness information, including airworthiness directives of the importing Party, as notified by that Party. 2. When issuing an export certificate of airworthiness for a used aircraft registered in the exporting Party, in addition to the requirements referred to in points (a) to (d) of paragraph 1, the competent authority of the exporting Party shall ensure that such aircraft has been properly maintained using approved procedures and methods of the exporting Party during its service life, as evidenced by logbooks and maintenance records. Article 26 Acceptance of an export certificate for a new civil aeronautical product The competent authority of the importing Party shall accept an export certificate issued by the competent authority or a production approval holder of the exporting Party for a civil aeronautical product, in accordance with the terms and conditions set out in this Annex and as detailed in the technical implementation procedures. Article 27 Acceptance of an export certificate of airworthiness for a used aircraft 1. The competent authority of the importing Party shall accept an export certificate of airworthiness issued by the competent authority of the exporting Party for a used aircraft in accordance with the terms and conditions set out in this Annex and the technical implementation procedures only if a holder of either a type certificate or a restricted type certificate exists for the used aircraft to support continued airworthiness of that type of aircraft. 2. For an export certificate of airworthiness for a used aircraft manufactured under the production oversight of the exporting Party to be accepted in accordance with paragraph 1, the competent authority of the exporting Party shall assist, upon request, the competent authority of the importing Party in obtaining data and information regarding: (a) the configuration of the aircraft at the time of dispatch from the manufacturer; and (b) subsequent changes and repairs applied to the aircraft that it has approved. 3. The importing Party may request inspection and maintenance records as detailed in the technical implementation procedures. 4. If, in the process of assessing the airworthiness status of a used aircraft considered for export, the competent authority of the exporting Party is unable to satisfy all of the requirements set out in Article 25(2) and in paragraphs 1 and 2 of this Article, it shall: (a) notify the competent authority of the importing Party; (b) coordinate with the competent authority of the importing Party, as detailed in the technical implementation procedures, their acceptance or rejection of the exceptions to the applicable requirements; and (c) keep a record of any accepted exceptions when exporting. SECTION G QUALIFICATION OF COMPETENT AUTHORITIES Article 28 Qualification requirements for the acceptance of findings of compliance and certificates 1. Each Party shall maintain a structured and effective certification and oversight system for the implementation of this Annex, including: (a) a legal and regulatory framework, ensuring in particular regulatory powers over entities regulated under the regulatory system for civil aviation safety of the Party; (b) an organisational structure, including a clear description of responsibilities; (c) sufficient resources, including qualified staff with sufficient knowledge, experience and training; (d) adequate processes documented in policies and procedures; (e) documentation and records; and (f) an established inspection programme ensuring uniform level of implementation of the legal and regulatory framework among the various components of the oversight system. Article 29 Continued qualifications of the competent authorities 1. In order to maintain mutual confidence in each Party's regulatory system concerning the implementation of this Annex so that they ensure a sufficiently equivalent level of safety, the technical agent of each Party shall regularly assess the other Party's competent authorities' compliance with the qualification requirements referred to in Article 28. The modalities of such continued mutual assessments shall be detailed in the technical implementation procedures. 2. The competent authority of a Party shall cooperate with the competent authority of the other Party whenever such assessments are required and ensure that regulated entities subject to its oversight provide access to the technical agents of the Parties. 3. If the technical agent of either Party believes that the technical competence of a competent authority of the other Party is no longer adequate, or that the acceptance of findings of compliance made or certificates issued by that competent authority should be suspended as the other Party's systems concerning the implementation of this Annex no longer ensure a sufficiently equivalent level of safety to permit such acceptance, the technical agents of the Parties shall consult in order to identify remedial actions. 4. If mutual confidence is not restored through mutually acceptable means, the technical agent of each Party may refer the matter referred to in paragraph 3 to the Certification Oversight Board. 5. If the matter is not resolved by the Certification Oversight Board, each Party may refer the matter referred to in paragraph 3 to the Specialised Committee on Aviation Safety. SECTION H COMMUNICATIONS, CONSULTATIONS AND SUPPORT Article 30 Communications Subject to the exceptions decided by the technical agents of the Parties on a case-by-case basis, all communications between the competent authorities of the Parties, including documentation as detailed in the technical implementation procedures, shall be made in the English language. Article 31 Technical consultations 1. The technical agents of the Parties shall address issues concerning the implementation of this Annex through consultations. 2. If a mutually acceptable solution is not reached through consultations held pursuant to paragraph 1, the technical agent of each Party may refer an issue as referred to in paragraph 1 to the Certification Oversight Board. 3. If the issue is not resolved by the Certification Oversight Board, each Party may refer an issue as referred to in paragraph 1 to the Specialised Committee on Aviation Safety. Article 32 Support for certification and continued airworthiness oversight activities Upon request, after mutual consent, and as resources permit, the competent authority of a Party may provide technical support, data and information to the competent authority of the other Party in certification and continued airworthiness oversight activities related to design, production and environmental protection certification. The support to be provided and the process for providing such support shall be detailed in the technical implementation procedures. ANNEX 31 TRANSPORT OF GOODS BY ROAD PART A REQUIREMENTS FOR ROAD HAULAGE OPERATORS IN ACCORDANCE WITH ARTICLE 463 OF THIS AGREEMENT SECTION 1 ADMISSION TO, AND THE PURSUIT OF, THE OCCUPATION OF ROAD HAULAGE OPERATOR Article 1 Scope This Section governs admission to, and the pursuit of, the occupation of road haulage operator and shall apply to all road haulage operators of a Party engaged in the transport of goods within the scope of Article 462 of this Agreement. Article 2 Definitions For the purposes of this Section, the following definitions apply: (a) "authorisation to pursue the occupation of road haulage operator" means an administrative decision which authorises a natural or legal person who fulfils the conditions laid down in this Section to pursue the occupation of road haulage operator; (b) "competent authority" means a national, regional or local authority in a Party which, for the purpose of authorising the pursuit of the occupation of road haulage operator, verifies whether a natural or legal person fulfils the conditions laid down in this Section, and which is empowered to grant, suspend or withdraw an authorisation to pursue the occupation of road haulage operator; and (c) "normal residence" means the place where a person usually lives, that is for at least 185 days in each calendar year, because of personal ties which show close links between that person and the place where that person is living. Article 3 Requirements for engagement in the occupation of road haulage operator Natural or legal persons engaged in the occupation of road haulage operator shall: (a) have an effective and stable establishment in a Party as laid down in Article 5 of this Section; (b) be of good repute as laid down in Article 6 of this Section; (c) have appropriate financial standing as laid down in Article 7 of this Section; and (d) have the requisite professional competence as laid down in Article 8 of this Section. Article 4 Transport manager 1. A road haulage operator shall designate at least one natural person to be the transport manager, who effectively and continuously manages its transport activities and fulfils the requirements set out in points (b) and (d) of Article 3 and who: (a) has a genuine link to the road haulage operator, such as being an employee, director, owner or shareholder or administering it, or is that person; and (b) is resident in the Party in the territory of which the road haulage operator is established. 2. If a natural or legal person does not fulfil the requirement of professional competence, the competent authority may authorise the natural or legal person to engage in the occupation of road haulage operator without designating a transport manager in accordance with paragraph 1, provided that: (a) the natural or legal person designates a natural person residing in the Party of establishment of the road haulage operator who fulfils the requirements laid down in points (b) and (d) of Article 3 and who is entitled under contract to carry out duties as transport manager on behalf of the undertaking; (b) the contract linking the natural or legal person with the person referred to in point (a) specifies the tasks to be performed on an effective and continuous basis by that person and indicates that person's responsibilities as transport manager. The tasks to be specified shall comprise, in particular, those relating to vehicle maintenance management, verification of transport contracts and documents, basic accounting, the assignment of loads or services to drivers and vehicles, and the verification of safety procedures; (c) in his or her capacity as transport manager, the person referred to in point (a) may manage the transport activities of up to four different road haulage operators carried out with a combined maximum total fleet of 50 vehicles; and (d) the person referred to in point (a) performs the specified tasks solely in the interests of the natural or legal person and that person's responsibilities are exercised independently of any natural or legal persons for which it carries out transport operations. 3. A Party may decide that a transport manager designated in accordance with paragraph 1 may not in addition be designated in accordance with paragraph 2, or may only be so designated in respect of a limited number of natural or legal persons or a fleet of vehicles that is smaller than that referred to in point (c) of paragraph 2. 4. The natural or legal person shall notify the competent authority of the transport manager or managers designated. Article 5 Conditions relating to the requirement of establishment In order to fulfil the requirement of effective and stable establishment in the Party of establishment, a natural or legal person shall: (a) have premises at which it is able to access the originals of its core business documents, whether in electronic or any other form in particular its transport contracts, documents relating to the vehicles at the disposal of the natural or legal person, accounting documents, personnel management documents, labour contracts, social security documents, documents containing data on the dispatching and posting of drivers, documents containing data relating to journeys, driving time and rest periods, and any other document to which the competent authority must have access in order to verify compliance with the conditions laid down in this Section; (b) be registered in the register of commercial companies of that Party or in a similar register whenever required under national law; (c) be subject to tax on revenues and, whenever required under national law, have assigned a VAT identification number; (d) once an authorisation has been granted, have at its disposal one or more vehicles which are registered or put into circulation and authorised to be used in conformity with the legislation of that Party, regardless of whether those vehicles are wholly owned or, for example, are held under a hire-purchase agreement or under a hire or leasing contract; (e) effectively and continuously conduct its administrative and commercial activities with the appropriate equipment and facilities at premises as referred to in point (a) situated in that Party and manage effectively and continuously its transport operations using the vehicles referred to in point (f) with the appropriate technical equipment situated in that Party; and (f) on an ongoing basis, have at its regular disposal a number of vehicles complying with the conditions laid down in point (d) and drivers normally based at an operational centre in that Party, proportionate to the volume of transport operations carried out by the undertaking. Article 6 Conditions relating to the requirement of good repute 1. Subject to paragraph 2, the Parties shall determine the conditions to be met by natural or legal persons and transport managers in order to fulfil the requirement of good repute. In determining whether a natural or legal person has fulfilled that requirement, the Parties shall consider the conduct of the natural or legal person, its transport managers, executive directors and any other relevant person as may be determined by the Party. Any reference in this Article to convictions, penalties or infringements shall include convictions, penalties or infringements of the natural or legal person itself, its transport managers, executive directors and any other relevant person as may be determined by the Party. The conditions referred to in this paragraph shall include at least the following: (a) that there be no compelling grounds for doubting the good repute of the transport manager or the road haulage operator, such as convictions or penalties for any serious infringement of national rules in force in the fields of: (i) commercial law; (ii) insolvency law; (iii) pay and employment conditions in the profession; (iv) road traffic; (v) professional liability; (vi) trafficking in human beings or drugs; (vii) tax law; and (b) that the transport manager or the road haulage operator have not in one or both Parties been convicted of a serious criminal offence or incurred a penalty for a serious infringement of the rules of Title I of Heading Three of Part Two of this Agreement or of national rules relating in particular to: (i) the driving time and rest periods of drivers, working time and the installation and use of recording equipment; (ii) the maximum weights and dimensions of commercial vehicles used in international traffic; (iii) the initial qualification and continuous training of drivers; (iv) the roadworthiness of commercial vehicles, including the compulsory technical inspection of motor vehicles; (v) access to the market in international road haulage; (vi) safety in the carriage of dangerous goods by road; (vii) the installation and use of speed-limiting devices in certain categories of vehicle; (viii) driving licences; (ix) admission to the occupation; (x) animal transport; (xi) the posting of workers in road transport; (xii) the law applicable to contractual obligations; and (xiii) journeys whose points of loading and unloading are situated in the other Party. 2. For the purposes of point (b) of the third subparagraph of paragraph 1 of this Article, where the transport manager or the road haulage operator has been convicted of a serious criminal offence or has incurred a penalty for one of the most serious infringements as set out in Appendix 31-A-1-1 in one or both Parties, the competent authority in the Party of establishment shall carry out and complete in an appropriate and timely manner an administrative procedure, which shall include, if appropriate, an on-site inspection at the premises of the natural or legal person concerned. During the administrative procedure, the competent authority shall assess whether, due to specific circumstances, the loss of good repute would constitute a disproportionate response in the individual case. In that assessment, the competent authority shall take into account the number of serious infringements of the rules as referred to in the third subparagraph of paragraph 1 of this Article, as well as the number of most serious infringements as set out in Appendix 31-A-1-1 for which the transport manager or the road haulage operator have been convicted or had penalties imposed on them. Any such finding shall be duly reasoned and justified. Where the competent authority finds that the loss of good repute would be disproportionate, it shall decide that the natural or legal person concerned continues to be of good repute. Where the competent authority does not find that the loss of good repute would be disproportionate, the conviction or penalty shall lead to the loss of good repute. 3. The Specialised Committee on Road Transport shall draw up a list of categories, types and degrees of seriousness of serious infringements which, in addition to those set out in Appendix 31-A-1-1, may lead to the loss of good repute. 4. The requirement of good repute shall not be fulfilled until a rehabilitation measure or any other measure having an equivalent effect has been taken pursuant to the relevant provisions of national law of the Parties. Article 7 Conditions relating to the requirement of financial standing 1. In order to fulfil the requirement of financial standing, a natural or legal person shall, on a permanent basis, be able to meet its financial obligations in the course of the annual accounting year. The natural or legal person shall demonstrate, on the basis of annual accounts certified by an auditor or a duly accredited person, that, every year, it has at its disposal capital and reserves: (a) totalling at least EUR 9 000 / GBP 8 000 when only one motor vehicle is used, EUR 5 000 / GBP 4 500 for each additional motor vehicle or combination of vehicles used that has a permissible laden mass exceeding 3.5 tonnes and EUR 900 / GBP 800 for each additional motor vehicle or combination of vehicles that has a permissible laden mass, exceeding 2.5 tonnes but not 3.5 tonnes; (b) natural or legal persons engaged in the occupation of road haulage operator solely by means of motor vehicles or combinations of vehicles that have a permissible laden mass exceeding 2.5 tonnes but not 3.5 tonnes shall demonstrate, on the basis of annual accounts certified by an auditor or a duly accredited person, that, every year, they have at their disposal capital and reserves totalling at least EUR 1 800 / GBP 1 600 when only one vehicle is used and EUR 900 / GBP 800 for each additional vehicle used. 2. By way of derogation from paragraph 1, the competent authority may agree or require that an undertaking demonstrate its financial standing by means of a certificate determined by the competent authority, such as a bank guarantee or an insurance, including a professional liability insurance from one or more banks or other financial institutions including insurance companies or another binding document providing a joint and several guarantee for the undertaking in respect of the amounts specified in point (a) of paragraph 1. 3. By way of derogation from paragraph 1, in the absence of certified annual accounts for the year of an undertaking's registration, the competent authority shall agree that an undertaking is to demonstrate its financial standing by means of a certificate, such as a bank guarantee, a document issued by a financial institution establishing access to credit in the name of the undertaking, or another binding document as determined by the competent authority proving that the undertaking has at its disposal the amounts specified in point (a) of paragraph 1. 4. The annual accounts referred to in paragraph 1, and the guarantee referred to in paragraph 2, which are to be verified, are those of the economic entity established in the Party in which an authorisation has been applied for and not those of any other entity established in the other Party. Article 8 Conditions relating to the requirement of professional competence 1. In order to satisfy the requirement of professional competence, the person or persons concerned shall possess knowledge corresponding to the level provided for in Part I of Appendix 31-A-1-2 in the subjects listed therein. That knowledge shall be demonstrated by means of a compulsory written examination which, if a Party so decides, may be supplemented by an oral examination. Those examinations shall be organised in accordance with Part II of Appendix 31-A-1-2. To this end, a Party may decide to impose training prior to the examination. 2. The persons concerned shall sit the examination in the Party in which they have their normal residence. 3. Only the authorities or bodies duly authorised for this purpose by a Party, in accordance with criteria defined by it, may organise and certify the written and oral examinations referred to in paragraph 1 of this Article. The Parties shall regularly verify that the conditions under which those authorities or bodies organise the examinations are in accordance with Appendix 31-A-1-2. 4. A Party may exempt the holders of certain higher education qualifications or technical education qualifications issued in that Party, specifically designated to this end and entailing knowledge of all the subjects listed in Appendix 31-A-1-2 from the examination in the subjects covered by those qualifications. The exemption shall only apply to those Sections of Part I of Appendix 31-A-1-2 for which the qualification covers all subjects listed under the heading of each Section. A Party may exempt from specified parts of the examinations holders of certificates of professional competence valid for national transport operations in that Party. Article 9 Exemption from examination For the purpose of granting a licence to a road haulage operator which only operates motor vehicles or combinations of vehicles the permissible laden mass of which does not exceed 3.5 tonnes, a Party may decide to exempt from the examinations referred to in Article 8(1) persons who provide proof that they have continuously managed, for the period of ten years before 20 August 2020, a natural or legal person of the same type. Article 10 Procedure for the suspension and withdrawal of authorisations 1. Where a competent authority establishes that a natural or legal person runs the risk of no longer fulfilling the requirements laid down in Article 3, it shall notify the natural or legal person thereof. Where a competent authority establishes that one or more of those requirements is no longer satisfied, it may set one of the following time limits for the natural or legal person to rectify the situation: (a) a time limit not exceeding 6 months, which may be extended by 3 months in the event of the death or physical incapacity of the transport manager, for the recruitment of a replacement transport manager where the transport manager no longer satisfies the requirement as to good repute or professional competence; (b) a time limit not exceeding 6 months where the natural or legal person has to rectify the situation by demonstrating that the natural or legal person has an effective and stable establishment; or (c) a time limit not exceeding 6 months where the requirement of financial standing is not satisfied, in order to demonstrate that that requirement is again satisfied on a permanent basis. 2. The competent authority may require a natural or legal person whose authorisation has been suspended or withdrawn to ensure that its transport managers have passed the examinations referred to in Article 8(1) prior to any rehabilitation measure being taken. 3. If the competent authority establishes that the natural or legal person no longer satisfies one or more of the requirements laid down in Article 3, it shall suspend or withdraw the authorisation to engage in the occupation of road haulage operator within the time limits referred to in paragraph 1 of this Article. Article 11 Declaration of unfitness of the transport manager 1. Where a transport manager loses good repute in accordance with Article 6, the competent authority shall declare that transport manager unfit to manage the transport activities of a road haulage operator. The competent authority shall not rehabilitate the transport manager earlier than one year from the date of the loss of good repute and before the transport manager has demonstrated to have followed appropriate training for a period of at least 3 months or an exam on the subjects listed in Part I of Appendix 31-A-1-2. 2. Where a transport manager loses good repute in accordance with Article 6, an application for rehabilitation may be introduced after no less than one year from the date of the loss of good repute. Article 12 Examination and registration of applications 1. The competent authorities in each Party shall record in the national electronic registers referred to in Article 13(1) the data relating to undertakings which they authorise. 2. When assessing the good repute of an undertaking, the competent authorities shall verify, whether at the time of the application the designated transport manager or managers are declared, in one of the Parties, unfit to manage the transport activities of an undertaking pursuant to Article 11. 3. The competent authorities shall regularly monitor whether undertakings which they have authorised to engage in the occupation of road haulage operators continue to fulfil the requirements referred to in Article 3. To that end, the competent authorities shall carry out checks, including, where appropriate, on-site inspections at the premises of the undertaking concerned, targeting those undertakings which are classed as posing an increased risk. Article 13 National electronic registers 1. The competent authorities shall keep a national electronic register of road transport undertakings which have been authorised to engage in the occupation of road haulage operator. 2. The Specialised Committee on Road Transport shall establish the data contained in the national registers of road transport undertakings and the conditions of access to this data. Article 14 Administrative cooperation between the competent authorities 1. The competent authorities in each Party shall designate a national contact point responsible for the exchange of information with the competent authorities of the other Party with regard to the application of this Section. 2. The competent authorities in each Party shall cooperate closely and shall swiftly provide one another with mutual assistance and with any other relevant information in order to facilitate the implementation and enforcement of this Section. 3. The competent authorities in each Party shall carry out individual checks to verify whether an undertaking meets the conditions governing admission to the occupation of road haulage operator whenever a competent authority in the other Party so requests in duly justified cases. It shall inform the competent authority in the other Party of the results of such checks and of the measures taken if it is established that the undertaking no longer fulfils the requirements laid down in this Section. 4. The competent authorities in each Party shall exchange information on convictions and penalties for any serious infringements referred to in Article 6(2). 5. The Specialised Committee on Road Transport shall establish detailed rules on the modalities of the exchange of information referred to in paragraphs 3 and 4. Appendix 31-A-1-1 MOST SERIOUS INFRINGEMENTS FOR THE PURPOSE OF ARTICLE 6(2) OF SECTION 1 OF PART A OF ANNEX 31 1. Exceeding time limits as follows: (a) exceeding the maximum 6-day or fortnightly driving time limits by margins of 25 % or more; (b) exceeding, during a daily working period, the maximum daily driving time limit by a margin of 50 % or more. 2. Not having a tachograph and/or speed limiter, or having in the vehicle and/or using a fraudulent device able to modify the records of the recording equipment and/or the speed limiter or falsifying record sheets or data downloaded from the tachograph and/or the driver card. 3. Driving without a valid roadworthiness certificate and/or driving with a very serious deficiency of, inter alia, the braking system, the steering linkages, the wheels/tyres, the suspension or chassis that would create such an immediate risk to road safety that it leads to a decision to immobilise the vehicle. 4. Transporting dangerous goods that are prohibited for transport or transporting such goods in a prohibited or non-approved means of containment or without identifying them on the vehicle as dangerous goods, thus endangering lives or the environment to such extent that it leads to a decision to immobilise the vehicle. 5. Carrying goods without holding a valid driving licence or carrying by an undertaking not holding a valid operator's licence as referred to in Article 463 of this Agreement. 6. Driving with a driver card that has been falsified, or with a card of which the driver is not the holder, or which has been obtained on the basis of false declarations and/or forged documents. 7. Carrying goods exceeding the maximum permissible laden mass by 20 % or more for vehicles the permissible laden weight of which exceeds 12 tonnes, and by 25 % or more for vehicles the permissible laden weight of which does not exceed 12 tonnes. Appendix 31-A-1-2 PART I LIST OF SUBJECTS REFERRED TO IN ARTICLE 8 OF SECTION 1 OF PART A OF ANNEX 31 The knowledge to be taken into consideration for the official recognition of professional competence by the Parties must cover at least the subjects listed below. In relation to those subjects, applicant road haulage operators must have the levels of knowledge and practical aptitude necessary for the management of a transport undertaking. The minimum level of knowledge, as indicated below, must correspond at least to the level of knowledge acquired during the course of compulsory education, which is supplemented either by vocational training and supplementary technical training or by secondary school or other technical training. A. Civil law The applicant must, in particular: (a) be familiar with the main types of contract used in road transport and with the rights and obligations arising therefrom; (b) be capable of negotiating a legally valid transport contract, notably with regard to conditions of carriage; (c) be able to consider a claim by the applicant's principal regarding compensation for loss of or damage to goods during transportation or for their late delivery, and to understand how such a claim affects the applicant's contractual liability; and (d) be familiar with the rules and obligations arising from the CMR Convention on the Contract for the International Carriage of Goods by Road, done in Geneva on 19 May 1956. B. Commercial law The applicant must, in particular: (a) be familiar with the conditions and formalities laid down for plying the trade, the general obligations incumbent upon transport operators (registration, record keeping, etc.) and the consequences of bankruptcy; and (b) have appropriate knowledge of the various forms of commercial companies and the rules governing their constitution and operation. C. Social law The applicant must, in particular, be familiar with the following: (a) the role and function of the various social institutions which are concerned with road transport (trade unions, works councils, shop stewards, labour inspectors, etc.); (b) the employers' social security obligations; (c) the rules governing work contracts for the various categories of worker employed by road transport undertakings (form of the contracts, obligations of the parties, working conditions and working hours, paid leave, remuneration, breach of contract, etc.); (d) the rules applicable to driving time, rest periods and working time, and the practical measures for applying those provisions; and (e) the rules applicable to the initial qualification and continuous training of drivers laid down in Section 1 of Part B of this Annex. D. Fiscal law The applicant must, in particular, be familiar with the rules governing: (a) value added tax (VAT) on transport services; (b) motor-vehicle tax; (c) the taxes on certain road haulage vehicles and tolls and infrastructure user charges; and (d) income tax. E. Business and financial management The applicant must, in particular: (a) be familiar with the laws and practices regarding the use of cheques, bills of exchange, promissory notes, credit cards and other means or methods of payment; (b) be familiar with the various forms of credit (bank credit, documentary credit, guarantee deposits, mortgages, leasing, renting, factoring, etc.) and the charges and obligations arising therefrom; (c) know what a balance sheet is, how it is set out and how to interpret it; (d) be able to read and interpret a profit and loss account; (e) be able to assess the undertaking's profitability and financial position, in particular on the basis of financial ratios; (f) be able to prepare a budget; (g) be familiar with the cost elements of the undertaking (fixed costs, variable costs, working capital, depreciation, etc.), and be able to calculate costs per vehicle, per kilometre, per journey or per tonne; (h) be able to draw up an organisation chart relating to the undertaking's personnel as a whole and to organise work plans, etc.; (i) be familiar with the principles of marketing, publicity and public relations, including transport services, sales promotion and the preparation of customer files, etc.; (j) be familiar with the different types of insurance relating to road transport (liability, accidental injury/life insurance, non-life and luggage insurance) and the guarantees and obligations arising therefrom; (k) be familiar with the applications of electronic data transmission in road transport; (l) be able to apply the rules governing the invoicing of road haulage services and know the meaning and implications of Incoterms; and (m) be familiar with the different categories of transport auxiliaries, their role, their functions and, where appropriate, their status. F. Access to the market The applicant must, in particular, be familiar with the following: (a) the occupational regulations governing road transport, industrial vehicle rental and subcontracting, and in particular the rules governing the official organisation of the occupation, admission to the occupation, authorisations for road transport operations, inspections and penalties; (b) the rules for setting up a road transport undertaking; (c) the various documents required for operating road transport services and the introduction of checking procedures to ensure that the approved documents relating to each transport operation, and in particular those relating to the vehicle, the driver, the goods and luggage are kept both in the vehicle and on the premises of the undertaking; (d) the rules on the organisation of the market in road haulage services, as well as the rules on freight handling and logistics; and (e) border formalities, the role and scope of T documents and TIR carnets, and the obligations and responsibilities arising from their use. G. Technical standards and technical aspects of operation The applicant must, in particular: (a) be familiar with the rules concerning the weights and dimensions of vehicles in the Parties and the procedures to be followed in the case of abnormal loads which constitute an exception to these rules; (b) be able to choose vehicles and their components (chassis, engine, transmission system, braking system, etc.) in accordance with the needs of the undertaking; (c) be familiar with the formalities relating to the type approval, registration and technical inspection of these vehicles; (d) understand what measures must be taken to reduce noise and to combat air pollution by motor vehicle exhaust emissions; (e) be able to draw up periodic maintenance plans for the vehicles and their equipment; (f) be familiar with the different types of cargo-handling and loading devices (tailboards, containers, pallets, etc.) and be able to introduce procedures and issue instructions for loading and unloading goods (load distribution, stacking, stowing, blocking and chocking, etc.); (g) be familiar with the various techniques of "piggy-back" and roll-on roll-off combined transport; (h) be able to implement procedures to comply with the rules on the carriage of dangerous goods and waste; (i) be able to implement procedures to comply with the rules on the carriage of perishable foodstuffs, notably those arising from the Agreement on the International Carriage of Perishable Foodstuffs and on the Special Equipment to be used for such Carriage (ATP); and (j) be able to implement procedures to comply with the rules on the transport of live animals. H. Road safety The applicant must, in particular: (a) know what qualifications are required for drivers (driving licence, medical certificates, certificates of fitness, etc.); (b) be able to take the necessary steps to ensure that drivers comply with the traffic rules, prohibitions and restrictions in force in the Parties (speed limits, priorities, waiting and parking restrictions, use of lights, road signs, etc.); (c) be able to draw up instructions for drivers to check their compliance with the safety requirements concerning the condition of the vehicles, their equipment and cargo, and concerning preventive measures to be taken; (d) be able to lay down procedures to be followed in the event of an accident and to implement appropriate procedures to prevent the recurrence of accidents or serious traffic offences; and (e) be able to implement procedures to properly secure goods and be familiar with the corresponding techniques. PART II ORGANISATION OF THE EXAMINATION 1. The Parties will organise a compulsory written examination which they may supplement by an optional oral examination to establish whether applicant road haulage operators have achieved the required level of knowledge in the subjects listed in Part I and in particular their capacity to use the instruments and techniques relating to those subjects and to fulfil the corresponding executive and coordination duties. (a) The compulsory written examination will involve two tests, namely: (i) written questions consisting of either multiple choice questions (each with four possible answers), questions requiring direct answers or a combination of both systems; and (ii) written exercises/case studies. The minimum duration of each test will be two hours. (b) Where an oral examination is organised, the Parties may stipulate that participation is subject to the successful completion of the written examination. 2. Where the Parties also organise an oral examination, they must provide, in respect of each of the three tests, for a weighting of marks of a minimum of 25 % and a maximum of 40 % of the total number of marks to be given. Where the Parties organise only a written examination, they must provide, in respect of each test, for a weighting of marks of a minimum of 40 % and a maximum of 60 % of the total number of marks to be given. 3. With regard to all the tests, applicants must obtain an average of at least 60 % of the total number of marks to be given, achieving in any given test not less than 50 % of the total number of marks possible. In one test only, a Party may reduce that mark from 50 % to 40 %. Appendix 31-A-1-3 PART A LICENCE MODEL FOR THE UNION EUROPEAN COMMUNITY (a) (Colour Pantone light blue 290, or as close as possible to this colour, format DIN A4 cellulose paper 100 g/m2 or more) (First page of the licence) (Text in (one of) the official language(s) of the Member State issuing the licence) Distinguishing sign of the Member State( 1 ) issuing the licence Name of the competent authority or body LICENCE No ... or CERTIFIED TRUE COPY No ... for the international carriage of goods by road for hire or reward This licence entitles( 2 ) … … … to engage in the international carriage of goods by road for hire or reward by any route, for journeys or parts of journeys carried out for hire or reward within the territory of the Community, as laid down in Regulation (EC) No 1072/2009 of the European Parliament and of the Council of 21 October 2009 (OJ EU L 300, 14.11.2009, p. 72) on common rules for access to the international road haulage market and in accordance with the general provisions of this licence. Particular remarks: … … This licence is valid from …. to .… Issued in …, on … … ( 3 ) ______________ (1) The distinguishing signs of the Member States are: (B) Belgium, (BG) Bulgaria, (CZ) Czech Republic, (DK) Denmark, (D) Germany, (EST) Estonia, (IRL) Ireland, (GR) Greece, (E) Spain, (F) France, (HR) Croatia, (I) Italy, (CY) Cyprus, (LV) Latvia, (LT) Lithuania, (L) Luxembourg, (H) Hungary, (MT) Malta, (NL) Netherlands, (A) Austria, (PL) Poland, (P) Portugal, (RO) Romania, (SLO) Slovenia, (SK) Slovakia, (FIN) Finland, (S) Sweden. (2) Name or business name and full address of the haulier. (3) Signature and seal of the issuing competent authority or body. (b) (Second page of the licence) (Text in (one of) the official language(s) of the Member State issuing the licence) GENERAL PROVISIONS This licence is issued under Regulation (EC) No 1072/2009. It entitles the holder to engage in the international carriage of goods by road for hire or reward by any route for journeys or parts of journeys carried out within the territory of the Community and, where appropriate, subject to the conditions laid down herein: — where the point of departure and the point of arrival are situated in two different Member States, with or without transit through one or more Member States or third countries, — from a Member State to a third country or vice versa, with or without transit through one or more Member States or third countries, — between third countries with transit through the territory of one or more Member States, and unladen journeys in connection with such carriage. In the case of carriage from a Member State to a third country or vice versa, this licence is valid for that part of the journey carried out within the territory of the Community. It shall be valid in the Member State of loading or unloading only after the conclusion of the necessary agreement between the Community and the third country in question in accordance with Regulation (EC) No 1072/2009. The licence is personal to the holder and is non-transferable. It may be withdrawn by the competent authority of the Member State which issued it, notably where the holder has: — not complied with all the conditions for using the licence, — supplied incorrect information with regard to the data needed for the issue or extension of the licence. The original of the licence must be kept by the haulage undertaking. A certified copy of the licence must be kept in the vehicle( 1 ). In the case of a coupled combination of vehicles it must accompany the motor vehicle. It covers the coupled combination of vehicles even if the trailer or semi-trailer is not registered or authorised to use the roads in the name of the licence holder or if it is registered or authorised to use the roads in another State. The licence must be presented at the request of any authorised inspecting officer. Within the territory of each Member State, the holder must comply with the laws, regulations and administrative provisions in force in that State, in particular with regard to transport and traffic. __________________ (1) "Vehicle" means a motor vehicle registered in a Member State, or a coupled combination of vehicles the motor vehicle of which at least is registered in a Member State, used exclusively for the carriage of goods. PART B LICENCE MODEL FOR THE UNITED KINGDOM UK Licence for the Community (a) (Colour Pantone light blue, format DIN A4 cellulose paper 100 g/m2 or more) (First page of the licence) (Text in English or Welsh) UK NAME OF THE UK COMPETENT AUTHORITY ( 1 ) LICENCE No: Or CERTIFIED TRUE COPY No: for the international carriage of goods by road for hire or reward This licence entitles( 2 ) … … … to engage in the international carriage of goods by road for hire or reward by any route, for journeys or parts of journeys carried out for hire or reward within the territory of a Member State as laid down in Regulation (EC) No 1072/2009( 3 ). Particular remarks: … … This licence is valid from …. to … Issued in … on … ___________________________ (1) Competent authority for the relevant region for which the certificate is issued. (2) Name or business name and full address of the haulier. (3) Regulation (EC) No 1072/2009 as retained in UK law by Section 3 of the European Union (Withdrawal) Act 2018 and as amended by regulations made under Section 8 of that Act. (b) (Second page of the licence) (Text in English or Welsh) GENERAL PROVISIONS This licence is issued under Regulation (EC) No 1072/2009( 1 ). It entitles the holder to engage in the international carriage of goods by road for hire or reward by any route for journeys or parts of journeys carried out within the territory of a Member State permitted by any international agreement between the United Kingdom and the European Union or a Member State. In the case of carriage from the United Kingdom to a third country or vice versa, this licence is valid for that part of the journey carried out within the territory of any Member State. The licence is personal to the holder and is non-transferable. It may be withdrawn by a traffic commissioner or the Department for Infrastructure (Northern Ireland), for example, where the holder has: — not complied with all the conditions for using the licence, — supplied incorrect information with regard to the data needed for the issue or extension of the licence. The original of the licence must be kept by the haulage undertaking. A certified copy of the licence must be kept in the vehicle( 2 ). In the case of a coupled combination of vehicles it must accompany the motor vehicle. It covers the coupled combination of vehicles even if the trailer or semi-trailer is not registered or authorised to use the roads in the name of the licence holder or if it is registered or authorised to use the roads in another State. The licence must be presented at the request of any authorised inspecting officer. Within the territory of the United Kingdom or each Member State, the holder must comply with the laws, regulations and administrative provisions in force in that State, in particular with regard to transport and traffic. _______________________ (1) Regulation (EC) No 1072/2009 as retained in UK law by Section 3 of the European Union (Withdrawal) Act 2018 and as amended by regulations made under Section 8 of that Act. (2) "Vehicle" means a motor vehicle registered in the United Kingdom or a Member State, or a coupled combination of motor vehicles the motor vehicle of which at least is registered in the United Kingdom or a Member State, used exclusively for the carriage of goods. Appendix 31-A-1-4 SECURITY FEATURES OF THE LICENCE The licence must have at least two of the following security features: — a hologram; — special fibres in the paper which become visible under UV-light; — at least one microprint line (printing visible only with a magnifying glass and not reproduced by photocopying machines); — tactile characters, symbols or patterns; — double numbering: serial number of the licence, of the certified copy thereof as well as, in each case, the issue number; — a security design background with fine guilloche patterns and rainbow printing. SECTION 2 POSTING OF DRIVERS Article 1 Subject matter This Section lays down requirements for road haulage operators established in one of the Parties which, in the framework of the transport of goods, post drivers to the territory of the other Party in accordance with Article 3 of this Section. Nothing in this Section shall prevent a Party from applying measures to regulate the entry of natural persons into, or their temporary stay in, its territory, including measures necessary to protect the integrity of its borders and to ensure the orderly movement of natural persons across them, provided that such measures are not applied in such a manner as to nullify or impair the benefits accruing to the other Party under the terms of this Section. The sole fact of requiring a visa for natural persons of certain countries and not for those of others shall not be regarded as nullifying or impairing benefits under this Section. Nothing in this Section shall affect the application on the Union territory of the Union rules on the posting of drivers in road transport to Union road haulage operators. Article 2 Definitions For the purposes of this Section, "posted driver" means a driver who, for a limited period, carries out his or her work in the territory of a Party other than the Party in which the driver normally works. Article 3 Principles 1. The provisions of this Section apply to the extent that the road haulage operator posts drivers to the territory of the other Party on its account and under its direction, under a contract concluded between the road haulage operator making the posting and the party for whom the transport services are intended, and those drivers operate in the territory of that Party, provided that there is an employment relationship between the road haulage operator making the posting and the driver during the period of posting. 2. For the purposes of paragraph 1, a posting shall be considered to start when the driver enters the territory of the other Party for the loading and/or unloading of goods and to end when the driver leaves the territory of that Party. For the purposes of paragraph 1, in the case of posting in the Union, a posting shall, be considered to start when the driver enters the territory of a Member State for the loading and/or unloading of goods in that Member State and to end when the driver leaves the territory of that Member State. 3. Notwithstanding the paragraphs 1 and 2, a driver shall not be considered to be posted when performing transport operations, based on a transport contract, as defined in point (a) of Article 462(1) of this Agreement. 4. A driver shall not be considered to be posted in the United Kingdom where the driver transits through the territory of the United Kingdom without loading or unloading of goods. For the Union, a driver shall not be considered to be posted in a Member State when the driver transits through the territory of that Member State without loading or unloading of goods. Article 4 Terms and conditions of employment 1. Each Party shall ensure, irrespective of which law applies to the employment relationship, that road haulage operators guarantee, on the basis of equality of treatment, to drivers who are posted to their territory the terms and conditions of employment covering the following matters which, in the Party or, in the case of the Union, in the Member State where the work is carried out, are laid down: — by law, regulation or administrative provision, and/or — by collective agreements or arbitration awards which have been declared universally applicable or otherwise apply in accordance with paragraph 4: (a) maximum work periods and minimum rest periods; (b) minimum paid annual leave; (c) remuneration, including overtime rates; this point does not apply to supplementary occupational retirement pension schemes; (d) health, safety and hygiene at work; (e) protective measures with regard to the terms and conditions of employment of pregnant women or women who have recently given birth, of children and of young people; and (f) equality of treatment between men and women and other provisions on non-discrimination. 2. For the purposes of this Section, the concept of remuneration shall be determined by the national law and/or practice of the Party and, in the case of the Union, by the national law and/or practice of the Member State, to whose territory the driver is posted and means all the constituent elements of remuneration rendered mandatory by national law, regulation or administrative provision, or by collective agreements or arbitration awards which, in that Party or in that Member State, have been declared universally applicable or otherwise apply in accordance with paragraph 4. 3. Allowances specific to the posting shall be considered to be part of remuneration, unless they are paid in reimbursement of expenditure actually incurred on account of the posting, such as expenditure on travel, board and lodging. The road haulage operator shall reimburse the posted driver for such expenditure in accordance with the law and/or practice applicable to the employment relationship. Where the terms and conditions of employment applicable to the employment relationship do not determine which elements of the allowance specific to the posting are paid in reimbursement of expenditure actually incurred on account of the posting or which are part of remuneration, then the entire allowance shall be considered to be paid in reimbursement of expenditure. 4. For the purpose of this Section, "collective agreements or arbitration awards which have been declared universally applicable" means collective agreements or arbitration awards which must be observed by all undertakings in the geographical area and in the profession or industry concerned. In the absence of, or in addition to, a system for declaring collective agreements or arbitration awards to be of universal application within the meaning of the first subparagraph, each Party, or each Member State in the case of the Union, may, if they so decide, base themselves on: — collective agreements or arbitration awards which are generally applicable to all similar undertakings in the geographical area and in the profession or industry concerned; and/or — collective agreements which have been concluded by the most representative employers' and labour organisations at national level and which are applied throughout national territory. Equality of treatment, within the meaning of paragraph 1, shall be deemed to exist where national undertakings in a similar position: (i) are subject, in the place in question or in the sector concerned, to the same obligations as posting undertakings as regards the matters listed in the first subparagraph of paragraph 1; and (ii) are required to fulfil such obligations with the same effects. Article 5 Improved access to information 1. Each Party or, in the case of the Union, each Member State shall publish the information on the terms and conditions of employment, in accordance with national law and/or practice, without undue delay and in a transparent manner, on a single official national website, including the constituent elements of remuneration as referred to in Article 4(2) and all the terms and conditions of employment in accordance with Article 4(1). Each Party or, in the case of the Union, each Member State shall ensure that the information provided on the single official national website is accurate and up to date. 2. Each Party or, in the case of the Union, each Member State shall take the appropriate measures to ensure that the information mentioned in paragraph 1 is made generally available free of charge in a clear, transparent, comprehensive and easily accessible way at a distance and by electronic means, in formats and in accordance with web accessibility standards that ensure access to persons with disabilities and to ensure that competent national bodies are in a position to carry out their tasks effectively. 3. Where, in accordance with national law, traditions and practice, including respect for the autonomy of social partners, the terms and conditions of employment referred to in Article 4 are laid down in collective agreements in accordance with Article 4(1), each Party or, in the case of the Union, each Member State shall ensure that those terms and conditions are made available in an accessible and transparent way to service providers from the other Party and to posted drivers, and shall seek the involvement of the social partners in that respect. The relevant information should, in particular, cover the different minimum rates of pay and their constituent elements, the method used to calculate the remuneration due and, where relevant, the qualifying criteria for classification in the different wage categories. 4. Where, contrary to paragraph 1, the information on the single official national website does not indicate which terms and conditions of employment are to be applied, that circumstance shall be taken into account in accordance with national law and/or practice in determining penalties in the event of infringements to this Section, to the extent necessary to ensure the proportionality of those penalties. 5. Each Party or, in the case of the Union, each Member State shall indicate the bodies and authorities to which drivers and road haulage operators can turn for general information on national law and practice applicable to them concerning their rights and obligations within their territory. Article 6 Administrative requirements, control and enforcement 1. Each Party or, in the case of the Union, each Member State may only impose the following administrative requirements and control measures with respect to the posting of drivers: (a) an obligation for the operator established in the other Party to submit a posting declaration to the national competent authorities of the Party or, in the case of the Union, of the Member State to which the driver is posted at the latest at the commencement of the posting, using from 2 February 2022 a multilingual standard form of the public interface connected to the EU Internal Market Information System (1) for administrative cooperation (IMI); that posting declaration shall consist of the following information: (i) the identity of the operator, at least in the form of the number of the valid licence where this number is available; (ii) the contact details of a transport manager or other contact person in the Party of establishment or, in the case of the Union, in the Member State of establishment to liaise with the competent authorities of the host Party or in, the case of the Union, of the Member State in which the services are provided and to send out and receive documents or notices; (iii) the identity, the address of the residence and the number of the driving licence of the driver; (iv) the start date of the driver's contract of employment, and the law applicable to it; (v) the envisaged start and end date of the posting; and (vi) the number plates of the motor vehicles; (b) an obligation for the operator to ensure that the driver has at his or her disposal in paper or electronic form and an obligation for the driver to keep and make available when requested at the roadside: (i) a copy of the posting declaration submitted, via the IMI system from 2 February 2022; (ii) evidence of the transport operations taking place in the host Party, such as an electronic consignment note (e-CMR); and (iii) the tachograph records and in particular the country symbols of the Party or, in the case of the Union, of the Member State in which the driver was present when carrying out transport operations, in accordance with registration and record-keeping requirements under Section 2 of Part B and Section 4 of Part B; (c) an obligation for the operator to send, from 2 February 2022 via the public interface connected to the IMI system, after the period of posting, at the direct request of the competent authorities of the other Party or, in the case of the Union, of a Member State where the posting took place, copies of documents referred to in point (b)(ii) and (iii) of this paragraph as well as documentation relating to the remuneration of the driver in respect of the period of posting, the employment contract or an equivalent document, time-sheets relating to the driver's work, and proof of payments. The operator shall send the documentation, from 2 February 2022 via the public interface connected to the IMI system, no later than eight weeks from the date of the request. If the operator fails to submit the requested documentation within that time period, the competent authorities of the Party or, in the case of the Union, the Member State where the posting took place may request, from 2 February 2022 via the IMI system, the assistance of the competent authorities of the Party of establishment or, in the case of the Union, the Member State of establishment. When such a request for mutual assistance is made, the competent authorities of the Party of establishment or, in the case of the Union, the Member State of establishment of the operator shall have access to the posting declaration and other relevant information submitted by the operator, from 2 February 2022 via the public interface connected to the IMI system. The competent authorities of the Party of establishment or, in the case of the Union, of the Member State of establishment shall ensure that they provide the requested documentation to the competent authorities of the Party or, in the case of the Union, to the competent authorities of the Member State where the posting took place, from 2 February 2022 via the IMI system, within 25 working days from the day of the request for mutual assistance. Each Party shall ensure that the information exchanged by the competent national authorities or transmitted to them shall be used only in respect of the matter or matters for which it was requested. Mutual administrative cooperation and assistance shall be provided free of charge. A request for information shall not preclude the competent authorities from taking measures to investigate and prevent alleged breaches of this Section. 3. For the purpose of ascertaining whether a driver is not to be considered to be posted pursuant to Article 1, each Party may only impose as a control measure an obligation for the driver to keep and make available, where requested at the roadside check, in paper or electronic form, the evidence of the relevant transport operations, such as an electronic consignment note (e-CMR), and tachograph records, as referred to in point (b)(iii) of paragraph 2 of this Article. 4. For the purposes of control, the operator shall keep the posting declarations referred to in point (a) of paragraph 2 up to date, from 2 February 2022 in the public interface connected to IMI. 5. The information from the posting declarations shall be saved, from 2 February 2022, in the IMI repository for the purpose of checks for a period of 24 months. 6. The Party or, in the case of the Union, the Member State to whose territory the driver is posted and the Party or, in the case of the Union, the Member State from which the driver is posted shall be responsible for the monitoring, control and enforcement of the obligations laid down in this Section and shall take appropriate measures in the event of failure to comply with this Section. 7. Each Party or, in the case of the Union, the Member States shall ensure that inspections and controls of compliance under this Article are not discriminatory and/or disproportionate, whilst taking into account the relevant provisions of this Section. 8. For the enforcement of the obligations under this Section, each Party or, in the case of the Union, the Member States shall ensure that there are effective mechanisms for posted drivers to lodge complaints against their employers directly, as well as the right to institute judicial or administrative proceedings, also in the Party in whose territory the drivers are or were posted, where such drivers consider they have sustained loss or damage as a result of a failure to apply the applicable rules, even after the relationship in which the failure is alleged to have occurred has ended. 9. Paragraph 8 shall apply without prejudice to the jurisdiction of the courts of each Party or, in case of the Union, the Member States as laid down, in particular, in the relevant instruments of Union law and/or international conventions. 10. Each Party or, in the case of the Union, the Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Section and shall take all measures necessary to ensure that they are implemented and complied with. The penalties provided for shall be effective, proportionate and dissuasive. Each Party shall notify those provisions to the other Party by 30 June 2021. They shall notify without delay any subsequent amendments to them. Article 7 Use of the IMI system 1. As from 2 February 2022, information, including personal data, referred to in Article 6 shall be exchanged and processed in the IMI system, provided that the following conditions are fulfilled: (a) the Parties provide safeguards that data processed in the IMI system are only used for the purpose for which they were initially exchanged; (b) any transfer of personal data to the United Kingdom under this Article may only take place in accordance with point (c) of Article 23(1) of Regulation (EU) No 1024/2012 of the European Parliament and of the Council (2); and (c) any transfer of personal data to the Union under this Article may only take place in accordance with the data protection rules on international transfers of the United Kingdom. 2. The competent authorities in each Party shall grant and revoke appropriate access rights to IMI users. 3. IMI users are allowed to access personal data processed in the IMI system only on a need-to-know basis and exclusively for the purpose of implementation and enforcement of this Section. 4. Each Party or, in the case of the Union, each Member State, may allow the competent authority to provide national social partners by other means than the IMI system with relevant information available in the IMI system to the extent necessary for the purpose of checking compliance with posting rules and in accordance with national law and practices, provided that: (a) the information relates to a posting to the territory of the Party or, in the case of the Union, of the Member State, concerned; and (b) the information is used exclusively for the purpose of enforcing the posting rules. 5. The Specialised Committee on Road Transport shall set the technical and procedural specifications of the use of the IMI system by the United Kingdom. 6. Each Party shall participate in the operating costs of the IMI system. The Specialised Committee on Road Transport shall determine the costs to be borne by each Party. PART B REQUIREMENTS FOR DRIVERS INVOLVED IN THE TRANSPORT OF GOODS IN ACCORDANCE WITH ARTICLE 465 OF THIS AGREEMENT SECTION 1 CERTIFICATE OF PROFESSIONAL COMPETENCE Article 1 Scope This Section applies to the activity of driving by anyone employed or used by a road haulage operator of a Party undertaking journeys referred to in Article 462 of this Agreement and using vehicles for which a driving licence of category C1, C1+E, C or C+E, or a driving licence recognised as equivalent by the Specialised Committee on Road Transport, is required. Article 2 Exemptions A certificate of professional competence (CPC) is not required for drivers of vehicles: (a) with a maximum authorised speed not exceeding 45 km/h; (b) used by, or under the control of, the armed forces, civil defence, the fire service, forces responsible for maintaining public order, and emergency ambulance services, when the carriage is undertaken as a consequence of the tasks assigned to those services; (c) undergoing road tests for technical development, repair or maintenance purposes, or the drivers of new or rebuilt vehicles which have not yet been put into service; (d) used in states of emergency or assigned to rescue missions; (e) carrying material, equipment or machinery to be used by the drivers in the course of their work, provided that driving the vehicles is not the drivers' principal activity; or (f) used, or hired without a driver, by agricultural, horticultural, forestry, farming or fishery undertakings for carrying goods as part of their own entrepreneurial activity, except if driving is part of the driver's principal activity or the driving exceeds a distance set in national law from the base of the undertaking which owns, hires or leases the vehicle. Article 3 Qualification and training 1. The activity of driving as defined in Article 1 shall be subject to a compulsory initial qualification and to compulsory periodic training. To that end the Parties shall provide for: (a) a system of initial qualification corresponding to one of the following two options: (i) option combining both course attendance and a test In accordance with Section 2(2.1) of Appendix 31-B-1-1, this type of initial qualification involves compulsory course attendance for a specific period. It shall conclude with a test. Upon successful completion of the test, the qualification shall be certified by a CPC as provided for in point (a) of Article 6(1); (ii) option involving only tests In accordance with Section 2(2.2) of Appendix 31-B-1-1, this type of initial qualification does not involve compulsory course attendance but only theoretical and practical tests. Upon successful completion of the tests, the qualification shall be certified by a CPC as provided for in point (b) of Article 6(1). However, a Party may authorise a driver to drive within its territory before obtaining a CPC, where the driver is undergoing a national vocational training course of at least six months, for a maximum period of three years. In the context of that vocational training course, the tests referred to in points (i) and (ii) of this point may be completed in stages; (b) a system of periodic training In accordance with Section 4 of Appendix 31-B-1-1, periodic training involves compulsory course attendance. It shall be certified by a CPC as provided for in Article 8(1). 2. A Party may also provide for a system of accelerated initial qualification so that a driver may drive in the cases referred to in points (a)(ii) and (b) of Article 5(2). In accordance with Section 3 of Appendix 31-B-1-1, the accelerated initial qualification shall involve compulsory course attendance. It shall conclude with a test. Upon successful completion of the test, the qualification shall be certified by a CPC as provided for in Article 6(2). 3. A Party may exempt drivers who have obtained the certificate of professional competence provided for in Article 8 of Section 1 of Part A from the tests referred to in points (a)(i) and (ii) of paragraph 1 and in paragraph 2 of this Article in the subjects covered by the test provided for in that part of this Annex and, where appropriate, from attending the part of the course corresponding thereto. Article 4 Acquired rights Drivers who hold a category C1, C1+E, C or C+E licence, or a licence recognised as equivalent by the Specialised Committee on Road Transport, issued no later than 10 September 2009, shall be exempted from the need to obtain an initial qualification. Article 5 Initial qualification 1. Access to an initial qualification shall not require the corresponding driving licence to be obtained beforehand. 2. Drivers of a vehicle intended for the carriage of goods may drive: (a) from the age of 18: (i) a vehicle in licence categories C and C+E, provided they hold a CPC as referred to in Article 6(1); and (ii) a vehicle in licence categories C1 and C1+E, provided they hold a CPC as referred to in Article 6(2); (b) from the age of 21, a vehicle in licence categories C and C+E, provided they hold a CPC as referred to in Article 6(2). 3. Without prejudice to the age limits specified in paragraph 2, drivers undertaking carriage of goods who hold a CPC as provided for in Article 6 for one of the categories provided for in paragraph 2 of this Article shall be exempted from obtaining such a CPC for any other of the categories of vehicles referred to in that paragraph. 4. Drivers undertaking carriage of goods who broaden or modify their activities in order to carry passengers, or vice versa, and who hold a CPC as provided for in Article 6, shall not be required to repeat the common parts of the initial qualification, but rather only the parts specific to the new qualification. Article 6 CPC certifying the initial qualification 1. CPC certifying an initial qualification (a) CPC awarded on the basis of course attendance and a test In accordance with point (a)(i) of Article 3(1), the Parties shall require trainee drivers to attend courses in a training centre approved by the competent authorities in accordance with Section 5 of Appendix 31-B-1-1, hereinafter referred to as "approved training centre". Those courses shall cover all the subjects referred to in Section 1 of Appendix 31-B-1-1. That training shall conclude with successful completion of the test provided for in Section 2(2.1) of Appendix 31-B-1-1. That test shall be organised by the competent authorities in the Parties or an entity designated by them and shall serve to check whether, for the aforementioned subjects, the trainee driver has the level of knowledge required in Section 1 of Appendix 31-B-1-1. The said authorities or entities shall supervise the test and, upon successful completion, issue the drivers with a CPC certifying an initial qualification. (b) CPC awarded on the basis of tests In accordance with point (a)(ii) of Article 3(1), the Parties shall require trainee drivers to pass the theoretical and practical tests referred to in Section 2(2.2) of Appendix 31-B-1-1. Those tests shall be organised by the competent authorities in the Parties or an entity designated by them and shall serve to check whether, for all the aforementioned subjects, the trainee driver has the level of knowledge required in Section 1 of Appendix 31-B-1-1. The said authorities or entities shall supervise the tests and, upon successful completion, issue the drivers with a CPC certifying an initial qualification. 2. CPC certifying an accelerated initial qualification In accordance with Article 3(2), the Parties shall require trainee drivers to attend courses in an approved training centre. Those courses shall cover all the subjects referred to in Section 1 of Appendix 31-B-1-1. That training shall conclude with the test provided for in Section 3 of Appendix 31-B-1-1. That test shall be organised by the competent authorities in the Parties or an entity designated by them and shall serve to check whether, for the aforementioned subjects, the trainee driver has the level of knowledge required in Section 1 of Appendix 31-B-1-1. The said authorities or entities shall supervise the test and, upon successful completion, issue the drivers with a CPC certifying an accelerated initial qualification. Article 7 Periodic training Periodic training shall consist of training to enable holders of a CPC to update the knowledge which is essential for their work, with specific emphasis on road safety, health and safety at work, and the reduction of the environmental impact of driving. That training shall be organised by an approved training centre, in accordance with Section 5 of Appendix 31-B-1-1. Training shall consist of classroom teaching, practical training and, if available, training by means of information and communication technology (ICT) tools or on top-of-the-range simulators. If a driver moves to another undertaking, the periodic training already undergone must be taken into account. Periodic training shall be designed to expand on, and to revise, some of the subjects referred in Section 1 of Appendix 31-B-1-1. It shall cover a variety of subjects and shall always include at least one road safety related subject. The training subjects shall take into account developments in the relevant legislation and technology, and shall, as far as possible, take into account the specific training needs of the driver. Article 8 CPC certifying periodic training 1. When a driver has completed the periodic training referred to in Article 7, the competent authorities in the Parties or the approved training centre shall issue him or her with a CPC certifying periodic training. 2. The following drivers shall undergo a first course of periodic training: (a) holders of a CPC as referred to in Article 6, within five years of the issue of that CPC; and (b) the drivers referred to in Article 4, within five years of 10 September 2009. A Party may reduce or extend the periods of time referred to in point (a) or (b) by a maximum of two years. 3. A driver who has completed a first course of periodic training as referred to in paragraph 2 of this Article shall undergo periodic training every five years, before the end of the period of validity of the CPC certifying periodic training. 4. Holders of the CPC as referred to in Article 6 or the CPC as referred to in paragraph 1 of this Article and the drivers referred to in Article 4 who have ceased pursuit of the occupation and do not meet the requirements of paragraphs 1, 2 and 3 of this Article, shall undergo a course of periodic training before resuming pursuit of the occupation. 5. Drivers undertaking the carriage of goods by road who have completed courses of periodic training for one of the licence categories provided for in Article 5(2) shall be exempt from the obligation to undergo further periodic training for another of the categories provided for in that paragraph. Article 9 Enforcement The competent authorities in a Party shall either affix directly on the driver's driving permit (licence), beside the corresponding categories of licence, a distinguishing sign attesting to the possession of a CPC and indicating the date of expiry, or introduce a special driver qualification card which should be drawn up in accordance with the model reproduced in Appendix 31-B-1-2. Any other model may be acceptable provided that it is recognised as equivalent by the Specialised Committee on Road Transport. The driver qualification card or any equivalent document as specified above issued by the competent authorities in a Party shall be recognised by the other Party for the purposes of this Section. Drivers must be able to present, at the request of any authorised inspecting officer, a driving permit (licence) or a specific driver qualification card or equivalent document bearing the distinguishing sign confirming possession of a CPC. Appendix 31-B-1-1 MINIMUM QUALIFICATION AND TRAINING REQUIREMENTS To ensure that the rules governing the transport of goods by road covered by Title I of Heading Three of Part Two of this Agreement are as harmonised as possible, the minimum requirements for driver qualification and training as well as the approval of training centres are set out in Sections 1 to 5 of this Appendix. Any other content for this qualification or training may be acceptable provided that it is considered as equivalent by the Specialised Committee on Road Transport. SECTION 1 LIST OF SUBJECTS The knowledge to be taken into account by the Parties when establishing the driver's initial qualification and periodic training must include at least the subjects in this list. Trainee drivers must reach the level of knowledge and practical competence necessary to drive in all safety vehicles of the relevant licence category. The minimum level of knowledge may not be less than the level reached during compulsory education, supplemented by professional training. 1. Advanced training in rational driving based on safety regulations 1.1 Objective: to know the characteristics of the transmission system in order to make the best possible use of it: curves relating to torque, power, and specific consumption of an engine, area of optimum use of revolution counter, gearbox-ratio cover diagrams. 1.2 Objective: to know the technical characteristics and operation of the safety controls in order to control the vehicle, minimise wear and tear, and prevent disfunctioning: limits to the use of brakes and retarder, combined use of brakes and retarder, making better use of speed and gear ratio, making use of vehicle inertia, using ways of slowing down and braking on downhill stretches, action in the event of failure, use of electronic and mechanical devices such as Electronic Stability Program (ESP), Advanced Emergency Braking Systems (AEBS), Anti-Lock Braking System (ABS), traction control systems (TCS) and in vehicle monitoring systems (IVMS) and other, approved for use, driver assistance or automation devices. 1.3 Objective: ability to optimise fuel consumption: optimisation of fuel consumption by applying know-how as regards points 1.1 and 1.2, importance of anticipating traffic flow, appropriate distance to other vehicles and use of the vehicle's momentum, steady speed, smooth driving style and appropriate tyre pressure, and familiarity with intelligent transport systems that improve driving efficiency and assist in route planning. 1.4 Objective: ability to anticipate, assess and adapt to risks in traffic: to be aware of and adapt to different road, traffic and weather conditions, anticipate forthcoming events; to understand how to prepare and plan a journey during abnormal weather conditions; to be familiar with the use of related safety equipment and to understand when a journey has to be postponed or cancelled due to extreme weather conditions; to adapt to the risks of traffic, including dangerous behaviour in traffic or distracted driving (through the use of electronic devices, eating, drinking, etc.); to recognise and adapt to dangerous situations and to be able to cope with stress deriving therefrom, in particular related to size and weight of the vehicles and vulnerable road users, such as pedestrians, cyclists and powered two wheelers; to identify possible hazardous situations and properly interpret how those potentially hazardous situations may turn into situations where crashes can no longer be averted and selecting and implementing actions that increase the safety margins to such an extent that a crash can still be averted in case the potential hazards should occur. 1.5 Objective: ability to load the vehicle with due regard for safety rules and proper vehicle use: forces affecting vehicles in motion, use of gearbox ratios according to vehicle load and road profile, use of automatic transmission systems, calculation of payload of vehicle or assembly, calculation of total volume, load distribution, consequences of overloading the axle, vehicle stability and centre of gravity, types of packaging and pallets; main categories of goods needing securing, clamping and securing techniques, use of securing straps, checking of securing devices, use of handling equipment, placing and removal of tarpaulins. 2. Application of regulations 2.1 Objective: to know the social environment of road transport and the rules governing it: maximum working periods specific to the transport industry; principles, application and consequences of the rules related to the driving times and rest periods and those related to the tachograph; penalties for failure to use, improper use of and tampering with the tachograph; knowledge of the social environment of road transport: rights and duties of drivers as regards initial qualification and periodic training. 2.2 Objective: to know the regulations governing the carriage of goods: transport operating licences, documents to be carried in the vehicle, bans on using certain roads, road-use fees, obligations under standard contracts for the carriage of goods, drafting of documents which form the transport contract, international transport permits, obligations under the CMR Convention on the Contract for the International Carriage of Goods by Road, done in Geneva on 19 May 1956, drafting of the international consignment note, crossing borders, freight forwarders, special documents accompanying goods. 3. Health, road and environmental safety, service, logistics 3.1 Objective: to make drivers aware of the risks of the road and of accidents at work: types of accidents at work in the transport sector, road accident statistics, involvement of lorries/coaches, human, material and financial consequences. 3.2 Objective: ability to prevent criminality and trafficking in illegal immigrants: general information, implications for drivers, preventive measures, check list, legislation on transport operator liability. 3.3 Objective: ability to prevent physical risks: ergonomic principles; movements and postures which pose a risk, physical fitness, handling exercises, personal protection. 3.4 Objective: awareness of the importance of physical and mental ability: principles of healthy, balanced eating, effects of alcohol, drugs or any other substance likely to affect behaviour, symptoms, causes, effects of fatigue and stress, fundamental role of the basic work/rest cycle. 3.5 Objective: ability to assess emergency situations: behaviour in an emergency situation: assessment of the situation, avoiding complications of an accident, summoning assistance, assisting casualties and giving first aid, reaction in the event of fire, evacuation of occupants of a lorry, reaction in the event of aggression; basic principles for the drafting of an accident report. 3.6 Objective: ability to adopt behaviour to help enhance the image of the company: behaviour of the driver and company image: importance for the company of the standard of service provided by the driver, the roles of the driver, people with whom the driver will be dealing, vehicle maintenance, work organisation, commercial and financial effects of a dispute. 3.7 Objective: to know the economic environment of road haulage and the organisation of the market: road transport in relation to other modes of transport (competition, shippers), different road transport activities (transport for hire or reward, own account, auxiliary transport activities), organisation of the main types of transport company and auxiliary transport activities, different transport specialisations (road tanker, controlled temperature, dangerous goods, animal transport, etc.), changes in the industry (diversification of services provided, rail-road, subcontracting, etc.). SECTION 2 COMPULSORY INITIAL QUALIFICATION PROVIDED FOR IN POINT (a) OF ARTICLE 3(1) OF SECTION 1 OF PART B A Party may count specific other training related to the transport of goods by road required under its legislation as part of the training under this Section and under Section 3 of this Appendix. 2.1. Option combining both course attendance and a test Initial qualification must include the teaching of all subjects in the list under Section 1 of this Appendix. The duration of that initial qualification must be 280 hours. Each trainee driver must drive for at least 20 hours individually in a vehicle of the category concerned which meets at least the requirements for test vehicles. When driving individually, the trainee driver must be accompanied by an instructor, employed by an approved training centre. Each trainee driver may drive for a maximum of eight hours of the 20 hours of individual driving on special terrain or on a top-of-the-range simulator so as to assess training in rational driving based on safety regulations, in particular with regard to vehicle handling in different road conditions and the way they change with different atmospheric conditions, the time of day or night, and the ability to optimise fuel consumption. A Party and, in the case of the Union, a Member State may allow part of the training to be delivered by the approved training centre by means of ICT tools, such as e-learning, while ensuring that the high quality and the effectiveness of the training are maintained, and by selecting the subjects where ICT tools can most effectively be deployed. Reliable user identification and appropriate means of control shall be required in such a case. For the drivers referred to in Article 5(4) of Section 1 of Part B the length of the initial qualification must be 70 hours, including five hours of individual driving. At the end of that training, the competent authorities in the Parties or the entity designated by them shall give the driver a written or oral test. The test must include at least one question on each of the objectives in the list of subjects under Section 1 of this Appendix. 2.2 Option involving a test The competent authorities in the Parties or the entity designated by them shall organise the aforementioned theoretical and practical tests to check whether the trainee driver has the level of knowledge required in Section 1 of this Appendix for the subjects and objectives listed there. (a) The theoretical test shall consist of at least two parts: (i) questions including multiple-choice questions, questions requiring a direct answer, or a combination of both; and (ii) case studies. The minimum duration of the theoretical test must be four hours. (b) The practical test shall consist of two parts: (i) a driving test aimed at assessing training in rational driving based on safety regulations. The test must take place, whenever possible, on roads outside built-up areas, on fast roads and on motorways (or similar), and on all kinds of urban highways presenting the different types of difficulties that a driver is liable to encounter. It would be desirable for that test to take place in different traffic density conditions. The driving time on the road must be used optimally in order to assess the candidate in all traffic areas likely to be encountered. The minimum duration of that test must be 90 minutes; (ii) a practical test covering at least points 1.5, 3.2, 3.3 and 3.5 of Section 1 of this Appendix. The minimum duration of that test must be 30 minutes. The vehicle used for the practical test must meet at least the requirements for test vehicles. The practical test may be supplemented by a third test taking place on special terrain or on a top-of the-range simulator so as to assess training in rational driving based on safety regulations, in particular with regard to vehicle handling in different road conditions and the way they change with different atmospheric conditions and the time of day or night. The duration of that optional test is not fixed. Should the driver undergo such a test, its duration may be deducted from the 90 minutes of the driving test referred to under point (i), but the time deducted may not exceed 30 minutes. For the drivers referred to in Article 5(4) of Section 1 of Part B, the theoretical test must be limited to the subjects, referred to in Section 1 of this Appendix, which are relevant to the vehicles to which the new initial qualification applies. However, such drivers must undergo the whole practical test. SECTION 3 ACCELERATED INITIAL QUALIFICATION PROVIDED FOR IN ARTICLE 3(2) OF SECTION 1 OF PART B OF ANNEX 31 Accelerated initial qualification must include the teaching of all subjects in the list in Section 1 of this Appendix. Its duration must be 140 hours. Each trainee driver must drive for at least 10 hours individually in a vehicle of the category concerned which meets at least the requirements for test vehicles. When driving individually, the trainee driver must be accompanied by an instructor, employed by an approved training centre. Each trainee driver may drive for a maximum of four hours of the 10 hours of individual driving on special terrain or on a top-of-the-range simulator so as to assess training in rational driving based on safety regulations, in particular with regard to vehicle handling in different road conditions and the way those road conditions change with different atmospheric conditions, the time of day or night, and the ability to optimise fuel consumption. The provisions of the fourth paragraph of point 2.1 of Section 2 of this Appendix shall also apply to the accelerated initial qualification. For the drivers referred to in Article 5(4) of Section 1 of Part B, the length of the accelerated initial qualification must be 35 hours, including two-and-a-half hours of individual driving. At the end of that training, the competent authorities in the Parties or the entity designated by them shall give the driver a written or oral test. The test must include at least one question on each of the objectives in the list of subjects under Section 1 of this Appendix. A Party may count specific other training related to the transport of goods by road required under its legislation as part of the training under this Section. SECTION 4 COMPULSORY PERIODIC TRAINING PROVIDED FOR IN POINT (b) OF ARTICLE 3(1) OF SECTION 1 OF PART B OF ANNEX 31 Compulsory periodic training courses must be organised by an approved training centre. Their duration must be of 35 hours every five years, given in periods of at least seven hours, which may be split over two consecutive days. Whenever e- learning is used, the approved training centre shall ensure that the proper quality of the training is maintained, including by selecting the subjects where ICT tools can most effectively be deployed. In particular, the Parties shall require reliable user identification and appropriate means of control. The maximum duration of the e-learning training shall not exceed 12 hours. At least one of the training course periods shall cover a road safety related subject. The content of the training shall take into account training needs specific to the transport operations carried out by the driver and relevant legal and technological developments and should, as far as possible, take into account specific training needs of the driver. A range of different subjects should be covered over the 35 hours, including repeat training where it is shown that the driver needs specific remedial training. A Party and, in the case of the Union, a Member State may count specific other training related to the transport of goods by road required under its legislation as part of the training under this Section. SECTION 5 APPROVAL OF THE INITIAL QUALIFICATION AND PERIODIC TRAINING 5.1. The training centres taking part in the initial qualification and periodic training must be approved by the competent authorities in the Parties. Approval may be given only in response to a written application. The application must be accompanied by documents including: 5.1.1. a suitable qualification and training programme specifying the subjects taught and setting out the proposed implementing plan and teaching methods; 5.1.2. the instructors' qualifications and fields of activity; 5.1.3. information about the premises where the courses are given, the teaching materials, the resources made available for the practical work, and the vehicle fleet used; 5.1.4. the conditions regarding participation in the courses (number of participants). 5.2. The competent authority must give approval in writing subject to the following conditions: 5.2.1. the training must be given in accordance with the documents accompanying the application; 5.2.2. the competent authority must be entitled to send authorised persons to assist in the training courses of the approved centres, and must be entitled to monitor such centres, with regard to the resources used and the proper running of the training courses and tests; 5.2.3. the approval may be withdrawn or suspended if the conditions of approval are no longer complied with. The approved centre must guarantee that the instructors have a sound knowledge of the most recent regulations and training requirements. As part of a specific selection procedure, the instructors must provide certification showing a knowledge of both the subject material and teaching methods. As regards the practical part of the training, instructors must provide certification of experience as professional drivers or similar driving experience, such as that of driving instructors for heavy vehicles. The programme of instruction must be in accordance with the approval and must cover the subjects in the list in Section 1. Appendix 31-B-1-2 MODEL OF A DRIVER QUALIFICATION CARD REFERRED TO IN ARTICLE 9 OF SECTION 1 OF PART B OF THIS ANNEX SECTION 2 DRIVING TIMES, BREAKS AND REST PERIODS Article 1 Scope 1. This Section lays down the rules on driving time, breaks and rest periods for drivers referred to in point (b) of Article 465(1) of this Agreement undertaking journeys referred to in Article 462 of this Agreement. 2. Where a driver undertakes a journey referred to in Article 462 of this Agreement, the rules in this Section apply to any road transport operation undertaken by that driver between the territories of the Parties and between Member States. 3. This Section applies: (a) where the maximum permissible mass of the vehicle, including any trailer, or semitrailer, exceeds 3.5 tonnes; or (b) from 1 July 2026, where the maximum permissible mass of the vehicle, including any trailer, or semi-trailer, exceeds 2.5 tonnes. 4. This Section does not apply to transport by: (a) vehicles or combinations of vehicles with a maximum permissible mass not exceeding 7.5 tonnes used for: (i) carrying materials, equipment or machinery for the driver's use in the course of the driver's work, or (ii) for delivering goods which are produced on a craft basis, only within a 100 km radius from the base of the undertaking and on the condition that driving the vehicle does not constitute the driver's main activity and transport is not carried out for hire or reward; (b) vehicles with a maximum authorised speed not exceeding 40 km/h; (c) vehicles owned or hired without a driver by the armed services, civil defence services, fire services, and forces responsible for maintaining public order when the transport is undertaken as a consequence of the tasks assigned to those services and is under their control; (d) vehicles used in emergencies or rescue operations; (e) specialised vehicles used for medical purposes; (f) specialised breakdown vehicles operating within a 100 km radius of their base; (g) vehicles undergoing road tests for technical development, repair or maintenance purposes, and new or rebuilt vehicles which have not yet been put into service; (h) vehicles with a maximum permissible mass, including any trailer, or semi-trailer exceeding 2.5 tonnes but not exceeding 3.5 tonnes that are used for the transport of goods, where the transport is not effected for hire or reward, but on the own account of the company or the driver, and where driving does not constitute the main activity of the person driving the vehicle; (i) commercial vehicles, which have a historic status according to the legislation of the Member State in which they are being driven and which are used for the non-commercial transport of goods. Article 2 Definitions For the purposes of this Section, the following definitions apply: (a) "transport by road" means any journey made entirely or in part on roads open to the public by a vehicle, whether laden or not; (b) "break" means any period during which a driver may not carry out any driving or any other work and which is used exclusively for recuperation; (c) "other work" means all activities which are defined as working time in point (a) of Article 2(1) of Section 3 of Part B except "driving", including any work for the same or another employer, within or outside of the transport sector; (d) "rest" means any uninterrupted period during which a driver may freely dispose of his or her time; (e) "daily rest period" means the daily period during which a driver may freely dispose of his or her time and covers a "regular daily rest period" and a "reduced daily rest period": (i) "regular daily rest period" means any period of rest of at least 11 hours, which may be taken in two periods, the first of which must be an uninterrupted period of at least 3 hours and the second an uninterrupted period of at least nine hours; and (ii) "reduced daily rest period" means any period of rest of at least nine hours but less than 11 hours; (f) "weekly rest period" means the weekly period during which a driver may freely dispose of his or her time and covers a "regular weekly rest period" and a "reduced weekly rest period": (i) "regular weekly rest period" means any period of rest of at least 45 hours; and (ii) "reduced weekly rest period" means any period of rest of less than 45 hours, which may, subject to the conditions laid down in Article 6(6) and 6(7), be shortened to a minimum of 24 consecutive hours; (g) "a week" means the period of time between 00.00 on Monday and 24.00 on Sunday; (h) "driving time" means the duration of driving activity recorded: (i) automatically or semi-automatically by the tachograph as defined in points (e), (f), (g) and (h) of Article 2 of Section 4 of Part B of this Annex; or (ii) manually as required by Article 9(2) and Article 11 of Section 4 of Part B of this Annex; (i) "daily driving time" means the total accumulated driving time between the end of one daily rest period and the beginning of the following daily rest period or between a daily rest period and a weekly rest period; (j) "weekly driving time" means the total accumulated driving time during a week; (k) "maximum permissible mass" means the maximum authorised operating mass of a vehicle when fully laden; (l) "multi-manning" means the situation where, during each period of driving between any two consecutive daily rest periods, or between a daily rest period and a weekly rest period, there are at least two drivers in the vehicle to do the driving for the first hour of multimanning the presence of another driver or drivers is optional but for the remainder of the period it is compulsory; (m) "driving period" means the accumulated driving time from when a driver commences driving following a rest period or a break until the driver takes a rest period or a break; the driving period may be continuous or broken. Article 3 Requirement for drivers’ mates The minimum age for drivers' mates shall be 18 years. However, each Party and, in the case of the Union, a Member State may reduce the minimum age for drivers' mates to 16 years, provided that the reduction is for the purposes of vocational training and there is compliance with the limits imposed by the United Kingdom and, for the Union, the Member State's national rules on employment matters. Article 4 Driving times 1. The daily driving time shall not exceed nine hours. However, the daily driving time may be extended to at most 10 hours not more than twice during the week. 2. The weekly driving time shall not exceed 56 hours and shall not result in the maximum weekly working time of 60 hours being exceeded. 3. The total accumulated driving time during any two consecutive weeks shall not exceed 90 hours. 4. Daily and weekly driving times shall include all driving time on the territory of the Parties. 5. A driver shall record as other work any time spent as described in point (c) of Article 2 of this Section as well as any time spent driving a vehicle used for commercial operations where a driver is not required to record driving time, and shall record any periods of availability, as defined in point (2) of Article 2 of Section 3 of Part B, in accordance with point (b)(iii) of Article 6(5) of Section 4 of Part B. This record shall be entered either manually on a record sheet or printout or by use of manual input facilities on recording equipment. Article 5 Breaks After a driving period of four and a half hours a driver shall take an uninterrupted break of not less than 45 minutes, unless the driver takes a rest period. That break may be replaced by a break of at least 15 minutes followed by a break of at least 30 minutes each distributed over the period in such a way as to comply with the provisions of the first paragraph. A driver engaged in multi-manning may take a break of 45 minutes in a vehicle driven by another driver provided that the driver taking the break is not involved in assisting the driver driving the vehicle. Article 6 Rests 1. A driver shall take daily and weekly rest periods. 2. Within each period of 24 hours after the end of the previous daily rest period or weekly rest period a driver shall have taken a new daily rest period. If the portion of the daily rest period which falls within that 24-hour period is at least nine hours but less than 11 hours, then the daily rest period in question shall be regarded as a reduced daily rest period. 3. A daily rest period may be extended to make a regular weekly rest period or a reduced weekly rest period. 4. A driver may have at most three reduced daily rest periods between any two weekly rest periods. 5. By way of derogation from paragraph 2, within 30 hours of the end of a daily or weekly rest period, a driver engaged in multi-manning must have taken a new daily rest period of at least nine hours. 6. In any two consecutive weeks a driver shall take at least: (a) two regular weekly rest periods; or (b) one regular weekly rest period and one reduced weekly rest period of at least 24 hours. A weekly rest period shall start no later than at the end of six 24-hour periods from the end of the previous weekly rest period. 7. By way of derogation from paragraph 6, a driver engaged in international transport of goods may, outside the territory of the Party of the road haulage operator or, for drivers of Union road haulage operators, outside the territory of the Member State of the road haulage operator, take two consecutive reduced weekly rest periods provided that the driver in any four consecutive weeks takes at least four weekly rest periods, of which at least two shall be regular weekly rest periods. For the purpose of this paragraph, a driver shall be considered to be engaged in international transport where the driver starts the two consecutive reduced weekly rest periods outside the territory of the Party of the road haulage operator and drivers' place of residence or, for the Union, outside the territory of the Member State of the road haulage operator and the country of the drivers' place of residence. Any reduction in weekly rest period shall be compensated by an equivalent period of rest taken en bloc before the end of the third week following the week in question. Where two reduced weekly rest periods have been taken consecutively in accordance with the third subparagraph, the next weekly rest period shall be preceded by a rest period taken as compensation for those two reduced weekly rest periods. 8. Any rest taken as compensation for a reduced weekly rest period shall be attached to another rest period of at least nine hours. 9. The regular weekly rest periods and any weekly rest period of more than 45 hours taken in compensation for previous reduced weekly rest periods shall not be taken in a vehicle. They shall be taken in suitable gender-friendly accommodation with adequate sleeping and sanitary facilities. Any costs for accommodation outside the vehicle shall be covered by the employer. 10. Transport undertakings shall organise the work of drivers in such a way that the drivers are able to return to the employer's operational centre where the driver is normally based and where the driver's weekly rest period begins, in the United Kingdom and, in the case of the Union, the Member State of the employer's establishment, or to return to the drivers' place of residence, within each period of four consecutive weeks, in order to spend at least one regular weekly rest period or a weekly rest period of more than 45 hours taken in compensation for reduced weekly rest period. However, where the driver has taken two consecutive reduced weekly rest periods in accordance with paragraph 7, the transport undertaking shall organise the work of the driver in such a way that the driver is able to return before the start of the regular weekly rest period of more than 45 hours taken in compensation. The undertaking shall document how it fulfils that obligation and shall keep the documentation at its premises in order to present it at the request of control authorities. 11. A weekly rest period that falls in two weeks may be counted in either week, but not in both. 12. By way of derogation, where a driver accompanies a vehicle which is transported by ferry or train and takes a regular daily rest period or a reduced weekly rest period, that period may be interrupted not more than twice by other activities not exceeding one hour in total. During that regular daily rest or reduced weekly rest period the driver shall have access to a sleeper cabin, bunk or couchette at their disposal. With regard to regular weekly rest periods, that derogation shall only apply to ferry or train journeys where: (a) the journey is scheduled for 8 hours or more; and (b) the driver has access to a sleeper cabin in the ferry or on the train. 13. Any time spent travelling to a location to take charge of a vehicle falling within the scope of this Section, or to return from that location, when the vehicle is neither at the driver's home nor at the employer's operational centre where the driver is normally based, shall not be counted as a rest or break unless the driver is on a ferry or train and has access to a sleeper cabin, bunk or couchette. 14. Any time spent by a driver driving a vehicle which falls outside the scope of this Section to or from a vehicle which falls within the scope of this Section, which is not at the driver's home or at the employer's operational centre where the driver is normally based, shall count as other work. Article 7 Liability of road haulage operators 1. A road haulage operator of a Party shall not give drivers it employs or who are put at its disposal any payment, even in the form of a bonus or wage supplement, related to distances travelled, the speed of delivery and/or the amount of goods carried if that payment is of such a kind as to endanger road safety and/or encourages infringement of this Section. 2. A road haulage operator of a Party shall organise road transport operations and properly instruct crew members so that they are able to comply with the provisions of this Section. 3. A road haulage operator of a Party shall be liable for infringements committed by drivers of the operator, even if the infringement was committed on the territory of the other Party. Without prejudice to the right of the Parties to hold road haulage operators fully liable, the Parties may make this liability conditional on the operator's infringement of paragraphs 1 and 2. The Parties may consider any evidence that the road haulage operator cannot reasonably be held responsible for the infringement committed. 4. Road haulage operators, consignors, freight forwarders, principal contractors, subcontractors and driver employment agencies shall ensure that contractually agreed transport time schedules respect this Section. 5. A road haulage operator which uses vehicles that are fitted with recording equipment complying with point (f), (g) or (h) of Article 2 of Section 4 of Part B and that fall within the scope of this Section, shall: (i) ensure that all data are downloaded from the vehicle unit and driver card as regularly as is stipulated by the Party and that relevant data are downloaded more frequently so as to ensure that all data concerning activities undertaken by or for that road haulage operator are downloaded; and (ii) ensure that all data downloaded from both the vehicle unit and driver card are kept for at least 12 months following recording and, should an inspecting officer request it, such data are accessible, either directly or remotely, from the premises of the road haulage operator. For the purposes of this paragraph 'downloaded' shall be interpreted in accordance with the definition laid down in point (h) of Article 2(2) of Section 2 of Part C. The maximum period within which the relevant data shall be downloaded under point (i) of this paragraph shall be 90 days for data from the vehicle unit and 28 days for data from the driver card. Article 8 Exceptions 1. Provided that road safety is not thereby jeopardised and to enable the vehicle to reach a suitable stopping place, the driver may depart from Articles 4, 5 and 6 to the extent necessary to ensure the safety of persons, of the vehicle or its load. The driver shall indicate the reason for such departure manually on the record sheet of the recording equipment or on a printout from the recording equipment or in the duty roster, at the latest on arrival at the suitable stopping place. 2. Provided that road safety is not thereby jeopardised, in exceptional circumstances, the driver may also depart from Article 4(1) and (2) and from Article 6(2) by exceeding the daily and weekly driving time by up to one hour in order to reach the employer's operational centre or the driver's place of residence to take a weekly rest period. Under the same conditions, the driver may exceed the daily and weekly driving time by up to two hours, provided that an uninterrupted break of 30 minutes was taken immediately prior to the additional driving in order to reach the employer's operational centre or the driver's place of residence for taking a regular weekly rest period. The driver shall indicate the reason for such departure manually on the record sheet of the recording equipment, or on a printout from the recording equipment or in the duty roster, at the latest on arrival at the destination or the suitable stopping place. Any period of extension shall be compensated by an equivalent period of rest taken en bloc with any rest period, by the end of the third week following the week in question. 3. Provided that road safety is not thereby jeopardised, each Party and, in the case of the Union, a Member State may grant exceptions from Articles 3 to 6 and make such exceptions subject to individual conditions on its own territory or, with the agreement of the other Party, on the territory of the other Party, applicable to transport by the following: (a) vehicles owned or hired, without a driver, by public authorities to undertake transport by road which do not compete with private road haulage operators; (b) vehicles used or hired, without a driver, by agricultural, horticultural, forestry, farming or fishery undertakings for carrying goods as part of their own entrepreneurial activity within a radius of up to 100 km from the base of the undertaking; (c) agricultural tractors and forestry tractors used for agricultural or forestry activities, within a radius of up to 100 km from the base of the undertaking which owns, hires or leases the vehicle; (d) vehicles or combinations of vehicles with a maximum permissible mass not exceeding 7.5 tonnes used by universal service providers to deliver items as part of the universal service. Those vehicles shall be used only within a 100 km radius from the base of the undertaking, and on condition that driving the vehicles does not constitute the driver's main activity; (e) vehicles operating exclusively on islands not exceeding 2 300 square kilometres in area which are not linked to the rest of the national territory by a bridge, ford or tunnel open for use by motor vehicles; (f) vehicles used for the transport of goods within a 100 km radius from the base of the undertaking and propelled by means of natural or liquefied gas or electricity, the maximum permissible mass of which, including the mass of a trailer or semi-trailer, does not exceed 7.5 tonnes; (g) vehicles used in connection with sewerage, flood protection, water, gas and electricity maintenance services, road maintenance and control, door-to-door household refuse collection and disposal, telegraph and telephone services, radio and television broadcasting, and the detection of radio or television transmitters or receivers; (h) specialised vehicles transporting circus and funfair equipment; (i) specially fitted mobile project vehicles, the primary purpose of which is use as an educational facility when stationary; (j) vehicles used for milk collection from farms and/or for the return to farms of milk containers or milk products intended for animal feed; (k) specialised vehicles transporting money and/or valuables; (l) vehicles used for carrying animal waste or carcasses which are not intended for human consumption; (m) vehicles used exclusively on roads inside hub facilities such as ports, interports and railway terminals; (n) vehicles used for the transport of live animals from farms to local markets and vice versa or from markets to local slaughterhouses within a radius of up to 100 km; (o) vehicles or combinations of vehicles carrying construction machinery for a construction undertaking, up to a radius of 100 km from the base of the undertaking, provided that driving the vehicles does not constitute the driver's main activity; and (p) vehicles used for the delivery of ready-mixed concrete. 4. Provided that working conditions of drivers and road safety are not thereby jeopardised and that the limits set out in Article 3 of Section 3 of Part B are complied with, a Party, and in the case of the Union, a Member State, may grant temporary exceptions from the application of Articles 4, 5 and 6 of this Section to transport operations carried out in exceptional circumstances, in accordance with the procedure applicable in the Party. The temporary exceptions shall be duly reasoned and notified immediately to the other Party. The Specialised Committee on Road Transport shall specify the modalities of that notification. Each Party shall immediately publish that information on a public website and shall ensure that its enforcement activities to take into account an exception granted by the other Party. SECTION 3 WORKING TIME OF MOBILE WORKERS Article 1 Scope 1. This Section applies to mobile workers employed by road haulage operators of the Parties, undertaking journeys referred to in Article 462 of this Agreement. This Section shall also apply to self-employed drivers. 2. In so far as this Section contains more specific provisions as regards mobile workers performing road transport activities it shall take precedence over the relevant provisions of Article 387 of this Agreement. 3. This Section shall supplement the provisions of Section 2 of Part B which take precedence over the provisions of this Section. 4. A Party may disapply the application of this Section for mobile workers and self-employed drivers undertaking no more than two return journeys in accordance with Article 462 of this Agreement in a calendar month. 5. Where a Party disapplies the application of this Section under paragraph 4, that Party shall notify the other Party. Article 2 Definitions For the purposes of this Section, the following definitions apply: (1) "working time" means: (a) in the case of mobile workers: the time from the beginning to the end of work, during which the mobile worker is at his or her workstation, at the disposal of the employer and exercising his or her functions or activities, that is to say: — the time devoted to all road transport activities, in particular, the following: (i) driving; (ii) loading and unloading; (iii) assisting passengers boarding and disembarking from the vehicle; (iv) cleaning and technical maintenance; and (v) all other work intended to ensure the safety of the vehicle and its cargo or to fulfil the legal or regulatory obligations directly linked to the specific transport operation under way, including monitoring of loading and unloading, administrative formalities with police, customs, immigration officers etc., — the times during which driver cannot dispose freely of his or her time and is required to be at his or her workstation, ready to take up normal work, with certain tasks associated with being on duty, in particular during periods awaiting loading or unloading where their foreseeable duration is not known in advance, that is to say either before departure or just before the actual start of the period in question, or under the general conditions negotiated between the social partners and/or under the terms of the legislation of the Parties; (b) in the case of self-employed drivers, the same definition applies to the time from the beginning to the end of work, during which the self-employed driver is at his or her workstation, at the disposal of the client and exercising his or her functions or activities other than general administrative work that is not directly linked to the specific transport operation under way. The break times referred to in Article 4, the rest times referred to in Article 5 and, without prejudice to the legislation of the Parties or agreements between the social partners providing that such periods should be compensated or limited, the periods of availability referred to in point (2) of this Article, shall be excluded from working time; (2) "periods of availability" means: — periods other than those relating to break times and rest times during which the mobile worker is not required to remain at his or her workstation, but must be available to answer any calls to start or resume driving or to carry out other work. In particular such periods of availability shall include periods during which the mobile worker is accompanying a vehicle being transported by ferryboat or by train as well as periods of waiting at frontiers and those due to traffic prohibitions. — Those periods and their foreseeable duration shall be known in advance by the mobile worker, that is to say either before departure or just before the actual start of the period in question, or under the general conditions negotiated between the social partners and/or under the terms of the legislation of the Parties, — for mobile workers driving in a team, the time spent sitting next to the driver or on the couchette while the vehicle is in motion; (3) "workstation" means: — the location of the main place of business of the road haulage operator for which the person performing mobile road transport activities carries out duties, together with its various subsidiary places of business, regardless of whether they are located in the same place as its head office or main place of business, — the vehicle which the person performing mobile road transport activities uses when that person carries out duties, and — any other place in which activities connected with transportation are carried out; (4) "mobile worker" means, for the purpose of this Section, any worker forming part of the travelling staff, including trainees and apprentices, who is in the service of an undertaking which operates transport services for passengers or goods by road on the territory of the other Party; (5) "self-employed driver" means anyone whose main occupation is to transport of goods by road for hire or reward, who is entitled to work for himself and who is not tied to an employer by an employment contract or by any other type of working hierarchical relationship, who is free to organise the relevant working activities, whose income depends directly on the profits made and who has the freedom to, individually or through a cooperation between self-employed drivers, have commercial relations with several customers. For the purposes of this Section, those drivers who do not satisfy those criteria shall be subject to the same obligations and benefit from the same rights as those provided for mobile workers by this Section; (6) "person performing mobile road transport activities" means any mobile worker or self-employed driver who performs such activities; (7) "week" means the period between 00.00 hours on Monday and 24.00 hours on Sunday; (8) "night time" means a period of at least four hours, as defined by national law, between 00.00 hours and 07.00 hours; and (9) "night work" means any work performed during night time. Article 3 Maximum weekly working time 1. Each Party shall take the measures necessary to ensure that the average weekly working time may not exceed 48 hours. The maximum weekly working time may be extended to 60 hours only if, over four months, an average of 48 hours a week is not exceeded. 2. Each Party shall take the measures necessary to ensure that working time for different employers is the sum of the working hours. The employer shall ask the mobile worker concerned in writing for an account of time worked for another employer. The mobile worker shall provide such information in writing. Article 4 Breaks Each Party shall take the measures necessary to ensure that, without prejudice to the provisions of Section 2 of Part B of this Annex, persons performing mobile road transport activities, in no circumstances work for more than six consecutive hours without a break. Working time shall be interrupted by a break of at least 30 minutes, if working hours total between six and nine hours, and of at least 45 minutes, if working hours total more than nine hours. Breaks may be subdivided into periods of at least 15 minutes each. Article 5 Rest periods For the purposes of this Section, apprentices and trainees who are in the service of an undertaking which operates transport services for passengers or goods by road journeys on the territory of the other Party shall be covered by the same provisions on rest time as other mobile workers pursuant to Section 2 of Part B of this Annex. Article 6 Night work Each Party shall take the measures necessary to ensure that: (a) if night work is performed, the daily working time does not exceed ten hours in each 24 period, and (b) compensation for night work is given in accordance with national legislative measures, collective agreements, agreements between the two sides of industry and/or national practice, on condition that such compensation is not liable to endanger road safety. Article 7 Derogations 1. Derogations from Articles 3 and 6 may, for objective or technical reasons or reasons concerning the organisation of work, be adopted by means of collective agreements, agreements between the social partners, or if that is not possible, by laws, regulations or administrative provisions provided that there is consultation of the representatives of the employers and workers concerned and efforts are made to encourage all relevant forms of social dialogue. 2. The option to derogate from Article 3 may not result in the establishment of a reference period exceeding six months, for calculation of the average maximum weekly working time of forty-eight hours. 3. The Specialised Committee on Road Transport shall be informed of the derogations applied by a Party in accordance with paragraph 1. Article 8 Information and records Each Party shall ensure that: (a) mobile workers are informed of the relevant national requirements, the internal rules of the road haulage operator and agreements between the two sides of industry, in particular collective agreements and any company agreements, reached on the basis of this Section; and (b) the working time of persons performing mobile road transport activities is recorded. Records shall be kept for at least two years after the end of the period covered. Employers shall be responsible for recording the working time of mobile workers. Employers shall upon request provide mobile workers with copies of the records of hours worked. Article 9 More favourable provisions This Section shall not affect the right of each Party to apply or introduce laws, regulations or administrative provisions more favourable to the protection of the health and safety of persons performing mobile road transport activities, or their right to facilitate or permit the application of collective agreements or other agreements concluded between the two sides of industry which are more favourable to the protection of the health and safety of mobile workers. Those rules shall be applied in a non-discriminatory manner. SECTION 4 USE OF TACHOGRAPHS BY DRIVERS Article 1 Subject matter and principles This Section lays down requirements for drivers falling within the scope of Section 2 of Part B regarding the use of tachographs referred to in point (b) of Article 465(1) of this Agreement. Article 2 Definitions 1. For the purposes of this Section, the definitions set out in Article 2 of Section 2 of Part B apply. 2. In addition to the definitions referred to in paragraph 1, for the purposes of this Section the following definitions apply: (a) "tachograph" or "recording equipment" means the equipment intended for installation in road vehicles to display, record, print, store and output automatically or semi-automatically details of the movement, including the speed, of such vehicles and details of certain periods of activity of their drivers; (b) "record sheet" means a sheet designed to accept and retain recorded data, to be placed in an analogue tachograph, and on which the marking devices of the analogue tachograph continuously inscribe the information to be recorded; (c) "tachograph card" means a smart card, intended for use with the tachograph, which allows identification by the tachograph of the role of the cardholder and allows data transfer and storage; (d) "driver card" means a tachograph card, issued by the competent authorities in a Party to a particular driver, which identifies the driver and allows for the storage of driver activity data; (e) "analogue tachograph" means a tachograph complying with the specifications in Annex I to Regulation (EU) No 165/2014 of the European Parliament and of the Council (3), as adapted by Appendix 31-B-4-1; (f) "digital tachograph" means a tachograph complying with one of the following set of specifications, as adapted by Appendix 31-B-4-2: — Annex IB to Regulation (EEC) No 3821/85 applicable until 30 September 2011; — Annex IB to Regulation (EEC) No 3821/85 applicable from 1 October 2011; or — Annex IB to Regulation (EEC) No 3821/85 applicable from 1 October 2012; (g) "smart tachograph 1" means a tachograph complying with Annex IC to Commission Implementing Regulation (EU) 2016/799 (4) applicable from 15 June 2019, as adapted by Appendix 31-B-4-3; (h) "smart tachograph 2" means a tachograph complying with the following requirements: — automatic recording of the border crossing; — recording of loading and unloading activities; — recording whether the vehicle is used for carriage of goods or passengers; and — with the specifications to be set out in the implementing acts referred to in the first paragraph of Article 11 of Regulation (EU) No 165/2014 of the European Parliament and of the Council (5), as adapted by a decision of the Specialised Committee on Road Transport; (i) "event" means an abnormal operation detected by the digital tachograph which may result from a fraud attempt; (j) "non-valid card" means a card detected as faulty, or whose initial authentication failed, or whose start of validity date is not yet reached, or whose expiry date has passed. Article 3 Use of driver cards 1. The driver card is personal. 2. A driver may hold no more than one valid driver card, and is only authorised to use his or her own personalised driver card. A driver shall not use a driver card which is defective or which has expired. Article 4 Issuing of driver cards 1. Driver cards shall be requested to the competent authority in the Party where the driver has his or her normal residence. 2. For the purposes of this Article, "normal residence" means the place where a person usually lives, that is for at least 185 days in each calendar year, because of personal and occupational ties, or, in the case of a person with no occupational ties, because of personal ties which show close links between that person and the place where that person is living. However, the normal residence of a person whose occupational ties are in a place different from their personal ties and who consequently lives in turn in different places situated in the two Parties shall be regarded as being the place of their personal ties, provided that such person returns there regularly. This last condition does not need to be complied with where the person is living in a Party in order to carry out a fixed-term assignment. 3. Drivers shall give proof of their normal residence by any appropriate means, such as their identity card or any other valid document. Article 5 Renewal of driver cards Where a driver wishes to renew his or her driver card, the driver shall apply to the competent authorities in the Party of his or her normal residence not later than 15 working days before the expiry date of the card. Article 6 Use of driver cards and record sheets 1. Drivers shall use record sheets or driver cards every day on which they drive, starting from the moment they take over the vehicle. The record sheet or driver card shall not be withdrawn before the end of the daily working period unless its withdrawal is otherwise authorised or is necessary in order to enter the symbol of the country after having crossed a border. No record sheet or driver card may be used to cover a period longer than that for which it is intended. 2. Drivers shall adequately protect the record sheets or driver cards, and shall not use dirty or damaged record sheets or driver cards. The driver shall ensure that, taking into account the length of the period of service, the printing of data from the tachograph at the request of a control officer can be carried out correctly in the event of an inspection. 3. When, as a result of being away from the vehicle, a driver is unable to use the tachograph fitted to the vehicle, the periods of time referred to in points (b)(ii), (b)(iii) and (b)(iv) of paragraph 5 shall: (a) if the vehicle is fitted with an analogue tachograph, be entered on the record sheet, either manually, by automatic recording or other means, legibly and without dirtying the record sheet; or (b) if the vehicle is fitted with a digital, smart 1 or smart 2 tachograph, be entered onto the driver card using the manual entry facility provided for in the tachograph. Each Party shall not impose on drivers a requirement to present forms attesting to their activities while away from the vehicle. 4. Where there is more than one driver on board a vehicle fitted with a digital, a smart 1 or smart 2 tachograph, each driver shall ensure that his or her driver card is inserted into the correct slot in the tachograph. Where there is more than one driver on board a vehicle fitted with an analogue tachograph, the drivers shall amend the record sheets as necessary, so that the relevant information is recorded on the record sheet of the driver who is actually driving. 5. Drivers shall: (a) ensure that the time recorded on the record sheet corresponds to the official time in the country of registration of the vehicle; (b) operate the switch mechanisms enabling the following periods of time to be recorded separately and distinctly: (i) under the sign: driving time, (ii) under the sign: "other work", which means any activity other than driving, as defined in point (a) of Article 2 of Section 3 of Part B, and also any work for the same or another employer within or outside of the transport sector, (iii) under the sign: "availability", as defined in point (b) of Article 2 of Section 3 of Part B, (iv) under the sign: breaks, rest, annual leave or sick leave, and (v) under the sign for "ferry/train": In addition to the sign: the rest period spent on a ferry or train as required in paragraph 12 of Article 6 of Section 2 of Part B. 6. Each driver of a vehicle fitted with an analogue tachograph shall enter the following information on his or her record sheet: (a) on beginning to use the record sheet — the driver's surname and first name; (b) the date and place where use of the record sheet begins and the date and place where such use ends; (c) the registration number of each vehicle to which the driver is assigned, both at the start of the first journey recorded on the record sheet and then, in the event of a change of vehicle, during use of the record sheet; (d) the odometer reading: (i) at the start of the first journey recorded on the record sheet, (ii) at the end of the last journey recorded on the record sheet, (iii) in the event of a change of vehicle during a working day, the reading on the first vehicle to which the driver was assigned and the reading on the next vehicle; (e) the time of any change of vehicle; and (f) the symbols of the countries in which the daily working period started and finished. The driver shall also enter the symbol of the country that the driver enters after crossing a border of an EU Member State and of the United Kingdom at the beginning of the driver's first stop in that Member State or the United Kingdom. That first stop shall be made at the nearest possible stopping place at or after the border. Where the crossing of the border takes place on a ferry or train, the driver shall enter the symbol of the country at the port or station of arrival. 7. The driver shall enter in the digital tachograph the symbols of the countries in which the daily working period started and finished. From 2 February 2022, the driver shall also enter the symbol of the country that the driver enters after crossing a border of a Member State and of the United Kingdom at the beginning of the driver's first stop in that Member State or the United Kingdom. That first stop shall be made at the nearest possible stopping place at or after the border. Where the crossing of the border takes place on a ferry or train, the driver shall enter the symbol of the country at the port or station of arrival. A Member State or the United Kingdom may require drivers of vehicles engaged in transport operations inside their territory to add more detailed geographic specifications to the country symbol, provided that each Party notifies in advance the other Party about those detailed geographic specifications. It shall not be necessary for drivers to enter the information referred to in the first sentence of the first subparagraph if the tachograph is automatically recording that location data. Article 7 Correct use of tachographs 1. Transport undertakings and drivers shall ensure the correct functioning and proper use of digital tachographs and driver cards. Transport undertakings and drivers using analogue tachographs shall ensure their correct functioning and the proper use of record sheets. 2. It shall be forbidden to falsify, conceal, suppress or destroy data recorded on the record sheet or stored in the tachograph or on the driver card, or print-outs from the tachograph. Any manipulation of the tachograph, record sheet or driver card which could result in data and/or printed information being falsified, suppressed or destroyed shall also be prohibited. No device which could be used to that effect shall be present on the vehicle. Article 8 Stolen, lost or defective driver cards 1. Issuing authorities of the Parties shall keep records of issued, stolen, lost or defective driver cards for a period at least equivalent to their period of validity. 2. If a driver card is damaged or if it malfunctions, the driver shall return it to the competent authority in the country of the driver's normal residence. Theft of the driver card shall be formally declared to the competent authorities of the State where the theft occurred. 3. Any loss of the driver card shall be reported in a formal declaration to the competent authorities in the issuing Party and to the competent authorities in the Party of the driver's normal residence if that is different. 4. If the driver card is damaged, malfunctions or is lost or stolen, the driver shall, within seven days, apply for its replacement to the competent authorities in the Party of the driver's normal residence. 5. In the circumstances set out in paragraph 4, the driver may continue to drive without a driver card for a maximum period of 15 days or for a longer period if that is necessary for the vehicle to return to the premises where it is based, provided that the driver can prove the impossibility of producing or using the card during that period. Article 9 Damaged driver cards and record sheets 1. In the event of damage to a record sheet bearing recordings or to a driver card, drivers shall keep the damaged record sheet or driver card together with any spare record sheet used to replace it. 2. Where a driver card is damaged, malfunctions, or is lost or stolen, the driver shall: (a) at the start of his or her journey, print out the details of the vehicle that the driver is driving, and enter on that printout: (i) details that enable the driver to be identified (name, driver card or driving licence number), including the driver's signature; and (ii) the periods referred to in points (b)(ii), (b)(iii) and (b)(iv) of Article 6(5); (b) at the end of the journey, print out the information relating to periods of time recorded by the tachograph, record any periods of other work, availability and rest taken since the printout made at the start of the journey, where not recorded by the tachograph, and mark on that document details enabling the driver to be identified (name, driver card or driving licence number), including the driver's signature. Article 10 Records to be carried by the driver 1. Where a driver drives a vehicle fitted with an analogue tachograph, the driver shall be able to produce, whenever an authorised control officer so requests: (i) the record sheets for the current day and the preceding 28 days; (ii) the driver card, if one is held; and (iii) any manual records and printouts made during the current day and the previous 28 days. 2. Where the driver drives a vehicle fitted with a digital, a smart 1 or smart 2 tachograph, the driver shall be able to produce, whenever an authorised control officer so requests: (i) the driver's driver card; (ii) any manual records and printouts made during the current day and the previous 28 days; and (iii) the record sheets corresponding to the same period as that referred to in point (ii) during which the driver drove a vehicle fitted with an analogue tachograph. From 31 December 2024, the period of 28 days referred to in points (i) and (iii) of paragraph 1 and in point (ii) of paragraph 2 shall be replaced by 56 days. 3. An authorised control officer may check compliance with Section 2 of Part B by analysis of the record sheets, of the displayed, printed or downloaded data which have been recorded by the tachograph or by the driver card or, failing that, of any other supporting document that justifies non-compliance with a provision of that Section. Article 11 Procedures for drivers in the event of malfunctioning equipment While the tachograph is unserviceable or malfunctioning, the driver shall mark data enabling him to be identified (name, driver card or driving licence number), including a signature, as well as the information for the various periods of time which are no longer recorded or printed out correctly by the tachograph: (a) on the record sheet or sheets; or (b) on a temporary sheet to be attached to the record sheet or to be kept together with the driver card. Article 12 Enforcement measures 1. Each Party shall adopt all appropriate measures to ensure observance of the provisions of Sections 2, 3 and 4 of Part B, in particular by ensuring annually an adequate level of roadside checks and checks performed at the premises of undertakings covering a large and representative cross-section of mobile workers, drivers, undertakings and vehicles of all transport categories falling within the scope of those Sections. The competent authorities in each Party shall organise the checks so that: (i) during each calendar year, a minimum of 3 % of the days worked by the drivers of vehicles falling within the scope of Section 2 of Part B applies shall be checked; and (ii) at least 30 % of the total number of working days checked shall be checked at the roadside and at least 50 % at the premises of undertakings. The elements of roadside checks shall include: (i) daily and weekly driving periods, interruptions and daily and weekly rest periods; (ii) the record sheets of the preceding days, which shall be on board the vehicle, and/or the data stored for the same period on the driver card and/or in the memory of the tachograph and/or on the printouts, when required; and (iii) the correct functioning of the tachograph. Those checks shall be carried out without discrimination among vehicles, undertakings and drivers whether resident or not, and regardless of the origin or destination of the journey or type of tachograph. The elements of checks on the premises of undertakings shall include, in addition to the elements subject to roadside checks: (i) weekly rest periods and driving periods between those rest periods; (ii) fortnightly driving limits; (iii) compensation for reduced weekly rest periods in accordance with Article 6(6) and (7) of Section 2 of Part B; and (iv) use of record sheets and/or vehicle unit and driver card data and printouts and/or the organisation of drivers' working time. 2. If the findings of a roadside check on the driver of a vehicle registered in the territory of the other Party provide grounds to believe that infringements have been committed which cannot be detected during the check due to lack of necessary data, the competent authorities in each Party shall assist each other to clarify the situation. In cases where, to that end, the competent authorities in a Party carry out a check at the premises of the undertaking, the results of that check shall be communicated to the competent authorities of the other Party. 3. The competent authorities in the Parties shall work in cooperation with each other in the organisation of concerted roadside checks. 4. Each Party shall introduce a risk rating system for undertakings based on the relative number and severity of any infringements, as set out in Appendix 31-A-1-1 and of any infringements included in the list drawn up by the Specialised Committee on Road Transport under Article 6(3) of Section 1 of Part A, that an individual undertaking has committed. 5. Undertakings with a high risk rating shall be checked more closely and more often. 6. Each Party and, in the case of the Union, each Member State, shall enable its competent authorities to impose a penalty on a road haulage operator and/or a driver for an infringement of the applicable provisions on driving time, breaks and rest periods detected on its territory and for which a penalty has not already been imposed, even where that infringement has been committed on the territory of the other Party or, in the case of the Union, the territory of a Member State or of a third country. Appendix 31-B-4-1 ADAPTATIONS TO THE TECHNICAL SPECIFICATIONS OF THE ANALOGUE TACHOGRAPH Annex I to Regulation (EU) No 165/2014 is adapted for the purpose of this Section as follows: (a) In Section III (Construction requirements for recording equipment), in paragraph 4.1 of subsection (c) (Recording instruments), for "points (ii), (iii) and (iv) of Article 34(5)(b) of this Regulation" substitute "points (ii), (iii) and (iv) of point (b) of Article 6(5) of Section 4 of Part B of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part." (b) In Section III (Construction requirements for recording equipment), in paragraph 4.2 of subsection (c) (Recording instruments), for "Article 34 of this Regulation" substitute "Article 6(5) of Section 4 of Part B of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part." (c) In Section IV (Record sheets), in the third subparagraph of paragraph 1 of subsection (a) (General points), for "Article 34 of this Regulation" substitute "Article 6(6) of Section 4 of Part B of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part. (d) In Section V (Installation of recording equipment), in the first subparagraph of paragraph 5, for "this Regulation" substitute "Section 4 of Part B and Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part". (e) In Section V (Installation of recording equipment), in the third subparagraph of paragraph 5, for "Part A of Annex II to Directive 2007/46/EC of the European Parliament and of the Council" substitute "the Consolidated Resolution on the Construction of Vehicles (R.E.3)" and for "this Regulation" substitute "Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part". (f) In Section VI (Checks and inspections), in the text before paragraph 1, after "Member States" insert "and the United Kingdom". (g) In Section VI (Checks and inspections), in the second subparagraph of paragraph 1 (Certification of new or repaired instruments), after "Member States" insert "and the United Kingdom", and for "this Regulation" substitute "Section 4 of Part B and Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part". (h) In Section VI (Checks and inspections), in subparagraph (b) of paragraph 3 (Periodic inspections), after "Member State" insert "and the United Kingdom". Appendix 31-B-4-2 ADAPTATIONS TO THE TECHNICAL SPECIFICATIONS OF THE DIGITAL TACHOGRAPH Annex IB to Regulation (EEC) No 3821/85, including the appendixes introduced by Council Regulation (EC) No 2135/98 (6), is adapted for the purpose of this Section as follows: 1. In the case of the United Kingdom, the references to "Member State" are replaced by "Party", except for the references in subsection IV (Construction and functional requirements for tachograph cards), paragraph 174 and subsection VII (Card issuing), paragraph 268a; 2. For "Council Regulation (EEC) No 3820/85" and "Regulation (EC) No 561/2006" substitute "Section 2 of Part B of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part"; Section I (Definitions) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 3. Point (u) is replaced by the following: "(u) 'effective circumference of the wheels' means the average of the distances travelled by each of the wheels moving the vehicle (driving wheels) in the course of one complete rotation. The measurement of those distances shall be made under standard test conditions as defined under requirement 414 and is expressed in the form 'l = … mm'. Vehicle manufacturers may replace the measurement of those distances by a theoretical calculation which takes into account the distribution of the weight on the axles, vehicle unladen in normal running order, namely with coolant fluid, lubricants, fuel, tools, spare-wheel and driver. The methods for such theoretical calculation are subject to approval by the competent authority in a Party and can take place only before tachograph activation;" 4. In point (bb), the reference to "Council Directive 92/6/EEC" is replaced by "the applicable law of each Party". 5. Point (ii) is replaced by the following: "'security certification' means: process to certify, by a Common Criteria certification body, that the recording equipment (or component) or the tachograph card under investigation fulfils the security requirements defined in Appendix 10 (Generic security targets);" 6. In point (mm), the reference to "Directive 92/23/EEC" is replaced by "UNECE Regulation No 54". 7. In point (nn), footnote 17 is replaced by the following: "'Vehicle Identification Number' means a fixed combination of characters assigned to each vehicle by the manufacturer, which consists of two sections: the first, composed of not more than six characters (letters or figures), identifying the general characteristics of the vehicle, in particular the type and model; the second, composed of eight characters of which the first four may be letters or figures and the other four figures only, providing, in conjunction with the first section, clear identification of a particular vehicle." 8. In point (rr), the first indent is replaced by the following: "– installed and used only in M1 and N1 type vehicles as defined in the Consolidated Resolution on the Construction of Vehicles (R.E.3)", Section II (General characteristics and functions of the recording equipment) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 9. In paragraph 004, the last subparagraph is deleted. Section III (Construction and functional requirements for recording equipment) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 10. In paragraph 065, the reference to "Directive 2007/46/EC" is replaced by "the Consolidated Resolution on the Construction of Vehicles (R.E.3)." 11. In paragraph 162, the reference to "Commission Directive 95/54/EC of 31 October 1995 adapting to technical progress Council Directive 72/245/EEC" is replaced by "UNECE Regulation No 10". Section IV (Construction and functional requirements for tachograph cards) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 12. In paragraph 174, the reference to "UK: The United Kingdom" is replaced by "For the United Kingdom, the distinguishing sign shall be the UK." 13. In paragraph 185, the reference to "Community territory" is replaced by "the territory of the Union and of the United Kingdom". 14. In paragraph 188, the reference to "Commission Directive 95/54/EC of 31 October 1995" is replaced by "UNECE Regulation No 10". 15. In paragraph 189, the last subparagraph is deleted. Section V (Installation of recording equipment) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 16. In paragraph 250a, the reference to "Regulation (EC) No 68/2009" is replaced by "Appendix 12 of this Annex." Section VI (Checks, inspections and repairs) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 17. The introductory sentence is replaced by the following: "Requirements on the circumstances in which seals may be removed, as referred to in Article 5(5) of Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, are defined in Chapter V(3) of this Annex" 18. Under subsection 1 (Approval of fitters or workshops), the reference to "Article 12(1) of this Regulation" is replaced by "Articles 5(1) and 8 of Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part". Section VII (Card issuing) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 19. In paragraph 268a, after "Member States", wherever it occurs, insert "and the United Kingdom". Section VIII (Type approval of recording equipment and tachograph cards) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 20. In paragraph 271, omit "in accordance with Article 5 of this Regulation". Appendix 1 (Data dictionary) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 21. In point 2.111, the reference to "Directive 92/23 (EEC) 31.3.1992, OJ L 129, p. 95" is replaced by "UNECE Regulation No 54". Appendix 9 (Type approval List of minimum required tests) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 22. In subpoint 5.1 of Section 2 (Vehicle unit functional tests), the reference to "Directive 95/54/EC" is replaced by "UNECE Regulation No 10". 23. In subpoint 5.1 of Section 3 (Motion sensor functional tests), the reference to "Directive 95/54/EC" is replaced by "UNECE Regulation No 10". Appendix 12 (Adaptor for M1 and N1 category vehicles) of Annex IB to Regulation (EEC) No 3821/85 is adapted for the purpose of this Section as follows: 24. In Section 4 (Construction and functional requirements for the adaptor) in paragraph 4.5 (performance characteristics) in ADA_023, for "Commission Directive 2006/28/EC adapting to technical progress Council Directive 72/245/EEC" substitute "UNECE Regulation No 10". 25. In point 5.1 of the table under subsection 7.2 (Functional certificate), for "Directive 2006/28/EC" substitute "UNECE Regulation No 10". Appendix 31-B-4-3 ADAPTATIONS TO THE TECHNICAL SPECIFICATIONS OF THE SMART TACHOGRAPH Commission Implementing Regulation (EU) 2016/799, including its annexes and appendixes, is adapted for the purpose of this Section as follows: 1. In the case of the United Kingdom, the references to "Member State" are replaced by "Party", except for the references in point (229) of subsection 4.1 and in point (424) of Section 7; 2. For "Regulation (EEC) No 3820/85" and "Regulation (EC) No 561/2006" substitute "Section 2 of Part B of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part"; 3. For "Regulation (EU) No 165/2014" substitute "Section 4 of Part B and Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, except for the references in point (402) of subsection 5.3 and in point (424) of Section 7"; 4. For "Directive (EU) 2015/719" and for "Council Directive 96/53/EC" substitute "Section 1 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part". Section 1 (Definitions) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 5. Point (u) is replaced by the following: "(u) 'effective circumference of the wheels' means: the average of the distances travelled by each of the wheels moving the vehicle (driving wheels) in the course of one complete rotation. The measurement of those distances shall be made under standard test conditions as defined under requirement 414 and is expressed in the form 'l = … mm'. Vehicle manufacturers may replace the measurement of those distances by a theoretical calculation which takes into account the distribution of the weight on the axles, vehicle unladen in normal running order, namely with coolant fluid, lubricants, fuel, tools, spare-wheel and driver. The methods for such theoretical calculation are subject to approval by the competent authority in a Party and can take place only before tachograph activation;"; 6. In point (hh), the reference to "Council Directive 92/6/EEC" is replaced by "the applicable law of each Party"; 7. In point (uu), the reference to "Directive 92/23/EEC" is replaced by "UNECE Regulation No 54"; 8. In point (vv), footnote 9 is replaced by the following: "'Vehicle Identification Number' means a fixed combination of characters assigned to each vehicle by the manufacturer, which consists of two sections: the first, composed of not more than six characters (letters or figures), identifying the general characteristics of the vehicle, in particular the type and model; the second, composed of eight characters of which the first four may be letters or figures and the other four figures only, providing, in conjunction with the first section, clear identification of a particular vehicle."; 9. In point (yy), the first indent is replaced by the following: "– installed and used only in M1 and N1 type vehicles as defined in the Consolidated Resolution on the Construction of Vehicles (R.E.3);"; 10. Point (aaa) is deleted; 11. In point (ccc), the first paragraph is replaced by "15 June 2019". Section 2 (General characteristics and functions of the recording equipment) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 12. The last subparagraph of paragraph (7) of subsection 2.1 is deleted. Section 3 (Construction and functional requirements for recording equipment) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 13. In point (200) of subsection 3.20, the second sentence of the third subparagraph is deleted. 14. Point (201) of subsection 3.20 is replaced by the following: "The vehicle unit may also be able to output the following data using an appropriate dedicated serial link independent from an optional CAN bus connection (ISO 11898 Road vehicles — Interchange of digital information — Controller Area Network (CAN) for high speed communication), to allow their processing by other electronic units installed in the vehicle: — current UTC date and time, — speed of the vehicle, — total distance travelled by the vehicle (odometer), — currently selected driver and co-driver activity, — information if any tachograph card is currently inserted in the driver slot and in the co-driver slot and (if applicable) information about the corresponding cards identification (card number and issuing country). Other data may also be output in addition to that minimum list. When the ignition of the vehicle is ON, those data shall be permanently broadcast. When the ignition of the vehicle is OFF, at least any change of driver or co-driver activity and/or any insertion or withdrawal of a tachograph card shall generate a corresponding data output. In the event that data output has been withheld whilst the ignition of the vehicle is OFF, that data shall be made available once the ignition of the vehicle is ON again. The driver consent shall be required in case personal data are transmitted." Section 4 (Construction and functional requirements for tachograph cards) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 15. In Point (229) of the subsection 4.1, the following subparagraph is added: "For the United Kingdom, the distinguishing sign shall be the UK."; 16. In point (237), for "Article 26.4 of Regulation (EU) No. 165/2014" substitute "Article 9(2) of Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part"; 17. In point (241) of subsection 4.4 of Chapter 4 of this Annex, the word "Community territory" is replaced by "the territory of the Union and of the United Kingdom"; 18. Point (246) in subsection 4.5 is deleted. Section 5 (Installation of recording equipment) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 19. The first paragraph of point (397) in subsection 5.2 is replaced by the following: "(397) For M1 and N1 vehicles only, and which are fitted with an adaptor in conformity with Appendix 16 of this Annex and where it is not possible to include all the information necessary, as described in Requirement 396, a second, additional, plaque may be used. In such cases, this additional plaque shall contain at least the last four indents described in Requirement 396."; 20. In point (402) of subsection 5.3, for "Article 22(3) of Regulation (EU) No 165/2014" substitute "Article 5(3) of Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part.". Section 6 (Checks, inspections and repairs) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 21. The introductory sentence is replaced by the following: "Requirements on the circumstances in which seals may be removed are defined in Chapter 5.3 of this Annex."; Section 7 (Card issuing) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 22. In point (424), after the reference to "Member States" insert "and the United Kingdom", and for the reference to "Article 31 of Regulation (EU) No 165/2014" substitute "Article 13 of Section 2 of Part C of Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part". Appendix 1 (Data dictionary) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 23. In point 2.163, for "Directive 92/23/EEC" substitute "UNECE Regulation No 54". Appendix 11 (Common security mechanisms) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 24. In point 9.1.4 (Equipment Level: Vehicle Units), in the first note below CSM_78, for "Regulation (EU) No 581/2010" substitute "Article 7(5) of Section 2 of Part B Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part". 25. In point 9.1.5 (Equipment level: Tachograph Cards), in the note below CSM_89, for "Regulation (EU) No 581/2010" substitute "Article 7(5) of Section 2 of Part B Annex 31 to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part". Appendix 12 (Positioning based on Global Navigation Satellite System (GNSS)) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 26. The second subparagraph of Section 1 (Introduction) is deleted. 27. In Section 2 (Specification of the GNSS receiver), the reference to "compatibility with the services provided by the Galileo and European Geostationary Navigation Overlay Service (EGNOS) programmes as set out in Regulation (EU) No 1285/2013 of the European Parliament and of the Council", is replaced by "compatibility with Satellite Based Augmentation Systems (SBAS)". Appendix 16 (Adaptor for M1 and N1 category vehicles) of Annex IC to Commission Implementing Regulation (EU) 2016/799 is adapted for the purpose of this Section as follows: 28. In point 5.1 in the table under Section (7) (Type approval of recording equipment when an adaptor is used), the reference to "Directive 2006/28/EC" is replaced by "UNECE Regulation No 10". PART C REQUIREMENTS FOR VEHICLES USED FOR THE TRANSPORT OF GOODS IN ACCORDANCE WITH ARTICLE 466 OF THIS AGREEMENT SECTION 1 WEIGHTS AND DIMENSIONS Article 1 Subject matter and principles The maximum weights and dimensions of the vehicles that may be used for journeys referred to in Article 462 of this Agreement are those set out in Appendix 31-C-1-1. Article 2 Definitions For the purposes of this Section, the following definitions apply: (a) "motor vehicle" means any power-driven vehicle which travels on the road by its own means; (b) "trailer" means any vehicle intended to be coupled to a motor vehicle excluding semitrailers, and constructed and equipped for the carriage of goods; (c) "semi-trailer" means any vehicle intended to be coupled to a motor vehicle in such a way that part of it rests on the motor vehicle with a substantial part of its weight and of the weight of its load being borne by the motor vehicle, and constructed and equipped for the carriage of goods; (d) "vehicle combination" means either: — a road train consisting of a motor vehicle coupled to a trailer; or — an articulated vehicle consisting of a motor vehicle coupled to a semi-trailer; (e) "conditioned vehicle" means any vehicle whose fixed or movable superstructures are specially equipped for the carriage of goods at controlled temperatures and whose side walls, inclusive of insulation, are each at least 45 mm thick; (f) "maximum authorised dimensions" means the maximum dimensions for use of a vehicle; (g) "maximum authorised weight" means the maximum weight for use of a laden vehicle; (h) "maximum authorised axle weight" means the maximum weight for use of a laden axle or group of axles; (i) "tonne" means the weight executed by the mass of a tonne and shall correspond to 9.8 kilonewtons (kN); (j) "indivisible load" means a load that cannot, for the purpose of carriage by road, be divided into two or more loads without undue expense or risk of damage and which owing to its dimensions or mass cannot be carried by a motor vehicle, trailer, road train or articulated vehicle complying with this Section in all respects; (k) "alternative fuels" means fuels or power sources which serve, at least partly, as a substitute for fossil oil sources in the energy supply to transport and which have the potential to contribute to its decarbonisation and enhance the environmental performance of the transport sector, consisting of: (i) electricity consumed in all types of electric vehicles; (ii) hydrogen; (iii) natural gas, including biomethane, in gaseous form (Compressed Natural Gas — CNG) and liquefied form (Liquefied Natural Gas — LNG); (iv) Liquefied Petroleum Gas (LPG); (v) mechanical energy from on-board storage/on-board sources, including waste heat, (l) "alternatively fuelled vehicle" means a motor vehicle powered wholly or in part by an alternative fuel; (m) "zero-emission vehicle" means a heavy goods vehicle without an internal combustion engine, or with an internal combustion engine that emits less than 1 g CO2/kWh; and (n) "intermodal transport operation" means the transport of one or more containers or swap bodies, with a length of no more than 45 feet, where the lorry, trailer, semi-trailer (with or without tractor unit), swap body or container uses the road on the initial and/or final leg of the journey and, on the other leg, rail or inland waterway or maritime services. Article 3 Special permits A vehicle or vehicle combination which exceeds the maximum weights or dimensions set out in Appendix 31-C-1-1 may only be allowed to circulate on the basis of a special permit issued without discrimination by the competent authorities, or on the basis of similar non-discriminatory arrangements agreed on a case-by-case basis with those authorities, where these vehicles or vehicle combinations carry or are intended to carry indivisible loads. Article 4 Local restrictions This Section shall not preclude the non-discriminatory application of road traffic provisions in force in each Party which permit the weight and/or dimensions of vehicles on certain roads or civil engineering structures to be limited. This includes the possibility to impose local restrictions on maximum authorised dimensions and/or weights of vehicles that may be used in specified areas or on specified roads, where the infrastructure is not suitable for long and heavy vehicles, such as city centres, small villages or places of special natural interest. Article 5 Aerodynamic devices attached to the rear of vehicles or vehicle combinations 1. Vehicles or vehicle combinations equipped with aerodynamic devices may exceed the maximum lengths provided for in point 1.1 of Appendix 31-C-1-1, to allow the addition of such devices to the rear of vehicles or vehicle combinations. Vehicles or vehicle combinations equipped with such devices shall comply with point 1.5 of Appendix 31-C-1-1, and any exceeding of the maximum lengths shall not result in an increase in the loading length of those vehicles or vehicle combinations. 2. The aerodynamic devices referred to in paragraph 1 shall fulfil the following operational conditions: (a) in circumstances where the safety of other road users or of the driver is at risk, they shall be folded, retracted or removed by the driver; (b) when aerodynamic devices and equipment exceed 500 mm in length in the in-use position they shall be retractable or foldable; (c) their use on urban and inter urban road infrastructures shall take into account the special characteristics of areas where the speed limit is less than or equal to 50 km/h and where vulnerable road users are more likely to be present; and (d) when retracted/folded, they shall not exceed the maximum authorised length by more than 20 cm. Article 6 Aerodynamic cabins Vehicles or vehicle combinations may exceed the maximum lengths laid down in point 1.1 of Appendix 31-C-1-1 provided that their cabs deliver improved aerodynamic performance, energy efficiency and safety performance. Vehicles or vehicle combinations equipped with such cabs shall comply with point 1.5 of Appendix 31-C-1-1 and any exceeding of the maximum lengths shall not result in an increase in the load capacity of those vehicles. Article 7 Intermodal transport operations 1. The maximum lengths laid down in point 1.1 of Appendix 31-C-1-1, subject where applicable to Article 6, and the maximum distance laid down in point 1.6 of Appendix 31-C-1-1, may be exceeded by 15 cm for vehicles or vehicle combinations engaged in the transport of 45-foot containers or 45-foot swap bodies, empty or loaded, provided that the road transport of the container or swap body in question is part of an intermodal transport operation carried out according to the conditions set by each Party. 2. For intermodal transport operations, the maximum authorised vehicle weight for articulate vehicles with five or six axles may be exceeded by two tonnes in the combination set out in point 2.2.2(a) of Appendix 31-C-1-1 and by four tonnes in the combination set out in point 2.2.2(b) of Appendix 31-C-1-1. The maximum authorised vehicle weight of these vehicles may not exceed 44 tonnes. Article 8 Proof of compliance 1. As proof of compliance with this Section, vehicles covered by it shall carry one of the following proofs: (a) a combination of the following two plates: — the manufacturer's statutory plate, which is a plate or label, affixed by the manufacturer on a vehicle that provides the main technical characteristics which are necessary for the identification of the vehicle and provides the competent authorities with the relevant information concerning the permissible maximum laden masses; and — a plate relating to dimensions as far as possible affixed next to the manufacturer's statutory plate and containing the following information: (i) name of the manufacturer; (ii) vehicle identification number; (iii) length of the motor vehicle, trailer or semi-trailer (L); (iv) width of the motor vehicle, trailer or semi-trailer (W); and (v) data for the measurement of the length of vehicle combinations: — the distance (a) between the front of the motor vehicle and the centre of the coupling device (coupling hook or fifth wheel); in the case of a fifth wheel with several coupling points, the minimum and maximum values must be given (amin and amax); — the distance (b) between the centre of the coupling device of the trailer (fifth wheel ring) or of the semi-trailer (king pin) and the rear of the trailer or of the semi-trailer; in the case of a device with several coupling points, the minimum and maximum values must be given (bmin and bmax); The length of vehicle combinations is the length of the motor vehicle and trailer or semi-trailer placed in a straight line behind each other. (b) a single plate containing the information on the two plates referred to in point (a); or (c) a single document issued by the competent authorities of a Party or, in the case of the Union, the Member State where the vehicle is registered or put into circulation containing the same information as the plates referred to in point (a). It shall be kept in a place easily accessible to inspection and shall be adequately protected. 2. If the characteristics of the vehicle no longer correspond to those indicated on the proof of compliance, the Party or, in the case of the Union, the Member State in which the vehicle is registered or put into circulation shall take the necessary steps to ensure that the proof of compliance is altered. 3. The plates and documents referred to in paragraph 1 shall be recognised by the Parties as the proof of vehicle compliance provided for in this Section. Article 9 Enforcement 1. Each Party shall take specific measures to identify vehicles or vehicle combinations in circulation that are likely to have exceeded the maximum authorised weight and that shall therefore be checked by the competent authorities of the Parties in order to ensure compliance with the requirements of this Section. This can be done with the aid of automatic systems set up on the road infrastructure, or by means of on-board weighing equipment installed in vehicles. Such on-board weighing equipment shall be accurate and reliable, fully interoperable and compatible with all vehicle types. 2. A Party shall not require on-board weighing equipment to be installed on vehicles or vehicle combinations which are registered in the other Party. 3. Where automatic systems are used to establish infringements of this Section and to impose penalties, such automatic systems shall be certified. Where automatic systems are used only for identification purposes, they need not be certified. 4. The Parties shall, in accordance with Article 14 of Section 1 of Part A, ensure that their competent authorities exchange information about infringements and penalties relating to this Article. Appendix 31-C-1-1 MAXIMUM WEIGHTS AND DIMENSIONS AND RELATED CHARACTERISTICS OF VEHICLES 1. Maximum authorised dimensions for vehicles (in metre; "m") 1.1 Maximum length: — motor vehicle 12.00 m — trailer 12.00 m — articulated vehicle 16.50 m — road train 18.75 m 1.2 Maximum width: (a) all vehicles except the vehicles referred to in point (b) 2.55 m (b) superstructures of conditioned vehicles or conditioned containers or swap bodies transported by vehicles 2.60 m 1.3 Maximum height (any vehicle) 4.00 m 1.4 Removable superstructures and standardised freight items such as containers are included in the dimensions specified in points 1.1, 1.2, 1.3, 1.6, 1.7, 1.8 and 4.4 1.5 Any motor vehicle or vehicle combination which is in motion must be able to turn within a swept circle having an outer radius of 12.50 m and an inner radius of 5.30 m 1.6 Maximum distance between the axis of the fifth-wheel king pin and the rear of a semi-trailer 12.00 m 1.7 Maximum distance measured parallel to the longitudinal axis of the road train from the foremost external point of the loading area behind the cabin to the rearmost external point of the trailer of the combination, minus the distance between the rear of the drawing vehicle and the front of the trailer 15.65 m 1.8 Maximum distance measured parallel to the longitudinal axis of the road train from the foremost external point of the loading area behind the cabin to the rearmost external point of the trailer of the combination 16.40 m 2. Maximum authorised vehicle weight (in tonnes) 2.1 Vehicles forming part of a vehicle combination 2.1.1 Two-axle trailer 18 tonnes 2.1.2 Three-axle trailer 24 tonnes 2.2 Vehicle combinations In the case of vehicle combinations including alternatively fuelled or zero-emission vehicles, the maximum authorised weights provided for in this Section are increased by the additional weight of the alternative fuel or zero-emission technology with a maximum of 1 tonne and 2 tonnes respectively. 2.2.1 Road trains with five or six axles (a) two-axle motor vehicle with three-axle trailer 40 tonnes (b) three-axle motor vehicle with two or three-axle trailer 40 tonnes 2.2.2 Articulated vehicles with five or six axles (a) two-axle motor vehicle with three-axle semi-trailer 40 tonnes (b) three-axle motor vehicle with two or three-axle semi-trailer 40 tonnes 2.2.3 Road trains with four axles consisting of a two-axle motor vehicle and a two-axle trailer 36 tonnes 2.2.4 Articulated vehicles with four axles consisting of a two-axle motor vehicle and a two-axle semi-trailer, if the distance between the axles of the semi-trailer: — is 1.3 m or greater but not more than 1.8 m 36 tonnes — is greater than 1.8 m 36 tonnes (+ 2 tonnes margin when the maximum authorised weight (MAW) of the motor vehicle (18 tonnes) and the MAW of the tandem axle of the semi-trailer (20 tonnes) are respected and the driving axle is fitted with twin tyres and air suspension or equivalent suspension) 2.3 Motor vehicles In the case of alternatively fuelled motor vehicles or zero-emission vehicles, the maximum authorised weights provided for in subsections 2.3.1 and 2.3.2 are increased by the additional weight of the alternative fuel or zero-emission technology with a maximum of 1 tonne and 2 tonnes respectively. 2.3.1 Two-axle motor vehicles 18 tonnes 2.3.2 Three-axle motor vehicles 25 tonnes (26 tonnes where the driving axle is fitted with twin tyres and air suspension or equivalent suspension, or where each driving axle is fitted with twin tyres and the maximum weight of each axle does not exceed 9.5 tonnes) 2.3.3 Four-axle motor vehicles with two steering axles 32 tonnes where the driving axle is fitted with twin tyres and air suspension or equivalent suspension, or where each driving axle is fitted with twin tyres and the maximum weight of each axle does not exceed 9.5 tonnes 3. Maximum authorised axle weight of the vehicles (in tonnes) 3.1 Single axles Single non-driving axle 10 tonnes 3.2 Tandem axles of trailers and semi-trailers The sum of the axle weights per tandem axle must not exceed, if the distance (d) between the axles is: — less than 1 m (d < 1.0) 11 tonnes — between 1.0 m and less than 1.3 m (1.0 ≤ d < 1.3) 16 tonnes — between 1.3 m and less than 1.8 m (1.3 ≤ d < 1.8) 18 tonnes — 1.8 m or more (1.8 ≤ d) 20 tonnes 3.3 Tri-axles of trailers and semi-trailers The sum of the axle weights per tri-axle must not exceed, if the distance (d) between the axles is: 1.3 m or less (d ≤ 1.3) 21 tonnes over 1.3 m and up to 1.4 m (1.3 <d ≤ 1.4) 24 tonnes 3.4 Driving axle Driving axle of the vehicles referred to in points 2.2 and 2.3 11.5 tonnes 3.5 Tandem axles of motor vehicles The sum of the axle weights per tandem axle must not exceed, if the distance (d) between the axles is: — less than 1 m (d < 1.0) 11.5 tonnes — 1.0 m or greater but less than 1.3 m (1.0 ≤ d < 1.3) 16 tonnes — 1.3 m or greater but less than 1.8 m (1.3 ≤ d < 1.8) 18 tonnes (19 tonnes where the driving axle is fitted with twin tyres and air suspension or equivalent suspension, or where each driving axle is fitted with twin tyres and where the maximum weight for each axle does not exceed 9.5 tonnes) 4. Other characteristics of the vehicles 4.1 All vehicles The weight borne by the driving axle or driving axles of a vehicle or vehicle combination must not be less than 25 % of the total laden weight of the vehicle or vehicle combination. 4.2 Road trains The distance between the rear axle of a motor vehicle and the front axle of a trailer must not be less than 3.00 m. 4.3 Maximum authorised weight depending on the wheelbase The maximum authorised weight in tonnes of a four-axle motor vehicle may not exceed five times the distance in metres between the axes of the foremost and rearmost axles of the vehicle. 4.4 Semi-trailers The distance measured horizontally between the axis of the fifth-wheel king pin and any point at the front of the semi-trailer must not exceed 2.04 m. SECTION 2 REQUIREMENTS FOR TACHOGRAPHS, DRIVERS' CARDS AND WORKSHOP CARDS Article 1 Subject-matter and principles This Section lays down the requirements for vehicles within the scope of Section 2 of Part B of this Annex regarding the installation, testing, and control of tachographs, as referred to in Article 466(2) of this Agreement. Article 2 Definitions 1. For the purposes of this Section, the definitions set out in Article 2 of Section 2 and in Article 2 of Section 4 of Part B of this Annex apply. 2. In addition to the definitions referred to in paragraph 1, for the purposes of this Section the following definitions apply: (a) "vehicle unit" means the tachograph excluding the motion sensor and the cables connecting the motion sensor. The vehicle unit may be a single unit or several units distributed in the vehicle, provided that it complies with the security requirements of this Section; the vehicle unit includes, among other things, a processing unit, a data memory, a time measurement function, two smart card interface devices for driver and co-driver, a printer, a display, connectors and facilities for entering the user's inputs; (b) "motion sensor" means a part of the tachograph providing a signal representative of vehicle speed and/or distance travelled; (c) "control card" means a tachograph card issued by the authorities of a Party to a national competent control authority which identifies the control body and, optionally, the control officer, and which allows access to the data stored in the data memory or in the driver cards and, optionally, in the workshop cards for reading, printing and/or downloading; (d) "workshop card" means a tachograph card issued by the authorities of a Party to designated staff of a tachograph manufacturer, a fitter, a vehicle manufacturer or a workshop, approved by that Party, which identifies the cardholder and allows for the testing, calibration and activation of tachographs, and/or downloading from them; (e) "activation" means the phase in which the tachograph becomes fully operational and implements all functions, including security functions, through the use of a workshop card; (f) "calibration" means, with regard to the digital tachograph, updating or confirming vehicle parameters, including vehicle identification and vehicle characteristics, to be held in the data memory through the use of a workshop card; (g) "downloading" from a digital or smart tachograph means the copying, together with the digital signature, of a part, or of a complete set, of data files recorded in the data memory of the vehicle unit or in the memory of a tachograph card, provided that this process does not alter or delete any stored data; (h) "fault" means an abnormal operation detected by the digital tachograph which may result from an equipment malfunction or failure; (i) "installation" means the mounting of a tachograph in a vehicle; (j) "periodic inspection" means a set of operations performed to check that the tachograph works properly, that its settings correspond to the vehicle parameters, and that no manipulation devices are attached to the tachograph; (k) "repair" means any repair of a motion sensor or of a vehicle unit that requires the disconnection of its power supply, or its disconnection from other tachograph components, or the opening of the motion sensor or vehicle unit; (l) "interoperability" means the capacity of systems and the underlying business processes to exchange data and to share information; (m) "interface" means a facility between systems which provides the media through which they can connect and interact; (n) "time measurement" means a permanent digital record of the coordinated universal date and time (UTC); and (o) "TACHOnet messaging system" means the messaging system complying with the technical specifications laid down in Annexes I to VII of Commission Implementing Regulation (EU) 2016/68 (7). Article 3 Installation 1. Tachographs as referred to in paragraph 2 shall be installed in vehicles: (a) where the maximum permissible mass of the vehicle, including any trailer, or semitrailer, exceeds 3.5 tonnes; or (b) from 1 July 2026, where the maximum permissible mass of the vehicle, including any trailer, or semi-trailer, exceeds 2.5 tonnes. 2. The tachographs are: (a) for vehicles put into service for the first time before 1 May 2006, an analogue tachograph; (b) for vehicles put into service for the first time between 1 May 2006 and 30 September 2011, the first version of the digital tachograph; (c) for vehicles put into service for the first time between 1 October 2011 and 30 September 2012, the second version of the digital tachograph; (d) for vehicles put into service for the first time between 1 October 2012 and 14 June 2019, the third version of the digital tachograph; (e) for vehicles registered for the first time from 15 June 2019 and until 2 years after the entry into force of the detailed specifications referred to in Article 2(2)(g) of Section 4 of Part B, a smart tachograph 1; and (f) for vehicles registered for the first time more than 2 years after the entry into force of the detailed specifications referred to in Article 2(2)(h) of Section 4 of Part B, a smart tachograph 2. 3. Each Party may exempt from the application of this Section the vehicles mentioned in Article 8(3) of Section 2 of Part B of this Annex. 4. Each Party may exempt from the application of this Section vehicles used for transport operations which have been granted an exception in accordance with Article 8(4) of Section 2 of Part B of this Annex. Each Party shall immediately notify each other when making use of this paragraph. 5. No later than three years from the end of the year of entry into force of the detailed technical specifications of the smart tachograph 2, vehicles mentioned in point (a) of paragraph 1 which are equipped with an analogue tachograph or a digital tachograph shall be fitted with a smart tachograph 2 when operating on the territory of a Party other than the one where they are registered. 6. No later than four years after the entry into force of the detailed technical specifications of the smart tachograph 2, vehicles mentioned in point (a) of paragraph 1 equipped with a smart tachograph 1, shall be equipped with a smart tachograph 2 when operating on the territory of a Party other than the one where they are registered. 7. From 1 July 2026, vehicles mentioned in point (b) of paragraph 1 shall be equipped with a smart tachograph 2 when operating on the territory of a Party other than the one where they are registered. 8. Nothing in this Section shall affect the application on the Union territory of the Union rules on recording equipment in road transport to Union road haulage operators. Article 4 Data protection 1. Each Party shall ensure that the processing of personal data in the context of this Section is carried out solely for the purpose of verifying compliance with this Section. 2. Each Party shall, in particular, ensure that personal data are protected against uses other than the one strictly referred to in paragraph 1 in relation to: (a) the use of a global navigation satellite system (GNSS) for the recording of location data as referred to in the technical specification for smart tachograph 1 and smart tachograph 2; (b) the electronic exchange of information on driver cards as referred to in Article 13, and in particular any cross-border exchanges of such data with third Parties; and (c) the keeping of records by road haulage operators as referred to in Article 15. 3. Digital tachographs shall be designed in such a way as to ensure privacy. Only data necessary for the purposes referred to in paragraph 1 shall be processed. 4. Owners of vehicles, road haulage operators and any other entity concerned shall comply with the relevant provisions on the protection of personal data. Article 5 Installation and repair 1. Tachographs may be installed or repaired only by fitters, workshops or vehicle manufacturers approved by the competent authorities in a Party for that purpose in accordance with Article 7. 2. Approved fitters, workshops or vehicle manufacturers shall seal the tachograph after having verified that it is functioning properly, and, in particular, in such a way as to ensure that no manipulation device can tamper with or alter the data recorded. 3. The approved fitter, workshop or vehicle manufacturer shall place a special mark on the seals which it affixes and, in addition, for digital, smart 1 and smart 2 tachographs, shall enter the electronic security data for carrying out authentication checks. Each Party shall keep and publish a register of the marks and electronic security data used and the necessary information related to the electronic security data used. 4. For the purpose of certifying that the installation of the tachograph took place in accordance with the requirements of this Section, an installation plaque shall be affixed in such a way as to be clearly visible and easily accessible. 5. Tachograph components shall be sealed. Any connections to the tachograph which are potentially vulnerable to tampering, including the connection between the motion sensor and the gearbox, and the installation plaque where relevant, shall be sealed. A seal shall be removed or broken only: — by fitters or workshops approved by the competent authorities under Article 7 for repair, maintenance or recalibration purposes of the tachograph, or by control officers properly trained and, where required authorised, for control purposes; or — for the purpose of vehicle repair or modification which affects the seal. In such cases, a written statement stating the date and time at which the seal was broken and giving the reasons for the seal removal shall be kept on board the vehicle. The removed or broken seals shall be replaced by an approved fitter or a workshop without undue delay and at the latest within seven days of their removal or breaking. When the seals have been removed or broken for control purposes, they may be replaced by a control officer equipped with sealing equipment and a unique special mark without undue delay. When a control officer removes a seal, the control card shall be inserted in the tachograph from the moment of the removal of the seal until the inspection is finished, including in the case of the placement of a new seal. The control officer shall issue a written statement containing at least the following information: — vehicle identification number; — name of the officer; — control authority and country; — number of the control card; — number of the removed seal; — date and time of seal removal; and — number of the new seal, where the control officer has placed a new seal. Before replacing the seals, a check and calibration of the tachograph shall be performed by an approved workshop, except where a seal has been removed or broken for control purposes and replaced by a control officer. Article 6 Inspections of tachographs 1. Tachographs shall be subject to regular inspection by approved workshops. Regular inspections shall be carried out at least every two years. 2. The inspections referred to in paragraph 1 shall check at least the following: — the tachograph is correctly fitted and appropriate for the vehicle; — the tachograph is working properly; — the tachograph carries the type-approval mark; — the installation plaque is affixed; — all seals are intact and effective; — there are no manipulation devices attached to the tachograph or traces of the use of such devices; and — the tyre size and the actual circumference of the tyres. 3. Workshops shall draw up an inspection report in cases where irregularities in the functioning of the tachograph had to be remedied, whether as a result of a periodic inspection or of an inspection carried out at the specific request of the national competent authority. They shall keep a list of all inspection reports drawn up. 4. Inspection reports shall be retained for a minimum period of two years from the time the report was made. Each Party shall decide whether inspection reports are to be retained or sent to the competent authority during that period. In cases where the inspection reports are kept by the workshop, upon request from the competent authority, the workshop shall make available the reports of inspections and calibrations carried out during that period. Article 7 Approval of fitters, workshops and vehicle manufacturers 1. Each Party or, in the case of the Union, each Member State shall approve, regularly control and certify the fitters, workshops and vehicle manufacturers which may carry out installations, checks, inspections and repairs of tachographs. 2. Each Party or, in the case of the Union, each Member State shall ensure that fitters, workshops and vehicle manufacturers are competent and reliable. For that purpose, they shall establish and publish a set of clear national procedures and shall ensure that the following minimum criteria are met: (a) the staff are properly trained; (b) the equipment necessary to carry out the relevant tests and tasks is available; and (c) the fitters, workshops and vehicle manufacturers are of good repute. 3. Audits of approved fitters or workshops shall be carried out as follows: (a) approved fitters or workshops shall be subject, at least every two years, to an audit of the procedures they apply when handling tachographs. The audit shall focus in particular on the security measures taken and the handling of workshop cards. Parties or, in the case of the Union, Member States may carry out these audits without conducting a site visit; and (b) unannounced technical audits of approved fitters or workshops shall also take place in order to check the calibrations, inspections and installations carried out. Those audits shall cover at least 10 % of the approved fitters and workshops annually. 4. Each Party and their competent authorities shall take appropriate measures to prevent conflicts of interests between fitters or workshops and road haulage operators. In particular, where there is a serious risk of a conflict of interests, additional specific measures shall be taken to ensure that the fitter or workshop complies with this Section. 5. The competent authorities of each Party shall withdraw approvals, either temporarily or permanently, from fitters, workshops and vehicle manufacturers which fail to meet their obligations under this Section. Article 8 Workshop cards 1. The period of validity of workshop cards shall not exceed one year. When renewing the workshop card, the competent authority shall ensure that the criteria listed in Article 7(2) are met by the fitter, workshop or vehicle manufacturer. 2. The competent authority shall renew a workshop card within 15 working days after receipt of a valid renewal request and all the necessary documentation. If a workshop card is damaged, malfunctions, or is lost or stolen, the competent authority shall supply a replacement card within five working days of receiving a detailed request to that effect. Competent authorities shall maintain a register of lost, stolen or defective cards. 3. If a Party or, in the case of the Union, a Member State withdraws the approval of a fitter, workshop or vehicle manufacturer as provided for in Article 7, it shall also withdraw the workshop cards issued thereto. 4. Each Party shall take all necessary measures to prevent the workshop cards distributed to approved fitters, workshops and vehicle manufacturers from being falsified. Article 9 Issuing of driver cards 1. Driver cards shall be issued, at the request of the driver, by the competent authority in a Party where the driver has his normal residence. Where the competent authorities in a Party issuing the driver card have doubts as to the validity of a statement as to normal residence, or for the purpose of certain specific controls, they may request any additional information or evidence from the driver. For the purposes of this Article, "normal residence" means the place where a person usually lives, that is for at least 185 days in each calendar year, because of personal and occupational ties, or, in the case of a person with no occupational ties, because of personal ties which show close links between that person and the place where he is living. However, the normal residence of a person whose occupational ties are in a place different from their personal ties and who consequently lives in turn in different places situated in the two Parties shall be regarded as being the place of their personal ties, provided that such person returns there regularly. This last condition need not be complied with where the person is living in a Party in order to carry out a fixed-term assignment. 2. In duly justified and exceptional cases, each Party or, in the case of the Union, a Member State may issue a temporary and non-renewable driver card valid for a maximum period of 185 days to a driver who does not have his normal residence in a Party, provided that such driver is in a labour law relationship with an undertaking established in the issuing Party and, in so far, presents a driver attestation when required. 3. The competent authorities of the issuing Party shall take appropriate measures to ensure that an applicant does not already hold a valid driver card and shall personalise the driver card, ensuring that its data are visible and secure. 4. The driver card shall not be valid for more than five years. 5. A valid driver card shall not be withdrawn or suspended unless the competent authorities of a Party find that the card has been falsified, or the driver is using a card of which he is not the holder, or the card held has been obtained on the basis of false declarations and/or forged documents. If such suspension or withdrawal measures are taken by a Party or, in the case of the Union, a Member State other than the issuing Party or, in the case of the Union, other than the issuing Member State, the former shall return the card to the authorities of the Party or, in the case of the Union, the authorities of the Member State which issued it, as soon as possible, indicating the reasons for the withdrawal or suspension. If the return of the card is expected to take longer than two weeks, the suspending or withdrawing Party or, in the case of the Union, the suspending or withdrawing Member State shall inform the issuing Party or, in the case of the Union, the issuing Member State within those two weeks of the reasons for suspension or withdrawal. 6. The competent authority of the issuing Party may require a driver to replace the driver card by a new one if this is necessary to comply with the relevant technical specifications. 7. Each Party shall take all necessary measures to prevent driver cards from being falsified. 8. This Article shall not prevent a Party or, in the case of the Union, a Member State from issuing a driver card to a driver who has his normal residence in a part of that Party's territory, to which this Annex does not apply, provided that the relevant provisions of this Section are applied in such cases. Article 10 Renewal of driver cards 1. Where, in the case of renewals, the Party of the driver's normal residence is different from that which issued his current card, and where the authorities of the former Party are requested to renew the driver card, they shall inform the authorities which issued the earlier card of the reasons for its renewal. 2. In the event of a request for the renewal of a card which is imminently about to expire, the competent authority shall supply a new card before the expiry date, provided that the request was sent within the time-limits laid down in Article 5 of Section 4 of Part B. Article 11 Stolen, lost or defective driver cards 1. Issuing authorities shall keep records of issued, stolen, lost or defective driver cards for a period at least equivalent to their period of validity. 2. If the driver card is damaged, malfunctions or is lost or stolen, the competent authorities in the Party of his normal residence shall supply a replacement card within eight working days after their receipt of a detailed request to that effect. Article 12 Mutual acceptance of driver cards 1. Each Party shall accept the driver cards issued by the other Party. 2. Where the holder of a valid driver card issued by a Party has established his normal residence in the other Party and has asked for his card to be exchanged for an equivalent driver card, it shall be the responsibility of the Party or, in the case of the Union, the Member State which carries out the exchange to verify whether the card produced is still valid. 3. Parties or, in the case of the Union, Member States carrying out an exchange shall return the old card to the authorities of the issuing Party or, in the case of the Union, the issuing Member State and indicate the reasons for so doing. 4. Where a Party or, in the case of the Union, a Member State replaces or exchanges a driver card, the replacement or exchange, and any subsequent replacement or exchange, shall be registered in that Party or, in the case of the Union, in that Member State. Article 13 Electronic exchange of information on driver cards 1. In order to ensure that an applicant does not already hold a valid driver card, Parties or, in the case of the Union, Member States shall maintain national electronic registers containing the following information on driver cards for a period at least equivalent to the period of validity of those cards: — surname and first name of the driver; — birth date and, if available, place of birth of the driver; — valid driving licence number and country of issue of the driving licence (if applicable); — status of the driver card; and — driver card number. 2. The electronic registers of the Parties or, in the case of the Union, the Member States shall be interconnected and accessible throughout the territory of the Parties, using the TACHOnet messaging system or a compatible system. In the case of the use of a compatible system, the exchange of electronic data with the other Party shall be possible through the TACHOnet messaging system. 3. When issuing, replacing and, where necessary, renewing a driver card, Parties or, in the case of the Union, Member States shall verify through electronic data exchange that the driver does not already hold another valid driver card. The data exchanged shall be limited to the data necessary for the purpose of this verification. 4. Control officers may have access to the electronic register in order to check the status of a driver card. Article 14 Settings of tachographs 1. Digital tachographs shall not be set in such a way that they automatically switch to a specific category of activity when the vehicle's engine or ignition is switched off, unless the driver remains able to choose manually the appropriate category of activity. 2. Vehicles shall not be fitted with more than one tachograph, except for the purposes of field tests. 3. Each Party shall forbid the production, distribution, advertising and/or selling of devices constructed and/or intended for the manipulation of tachographs. Article 15 Responsibility of road haulage operators 1. Road haulage operators shall be responsible for ensuring that their drivers are properly trained and instructed as regards the correct functioning of tachographs, whether digital, smart or analogue, shall make regular checks to ensure that their drivers make correct use thereof, and shall not give to their drivers any direct or indirect incentives that could encourage the misuse of tachographs. Road haulage operators shall issue a sufficient number of record sheets to drivers of vehicles fitted with analogue tachographs, taking into account the fact that record sheets are personal in character, the length of the period of service and the possible need to replace record sheets which are damaged or have been taken by an authorised control officer. Road haulage operators shall issue to drivers only record sheets of an approved model suitable for use in the equipment installed in the vehicle. The road haulage operator shall ensure that, taking into account the length of the period of service, the printing of data from the tachograph at the request of a control officer can be carried out correctly in the event of an inspection. 2. Road haulage operators shall keep record sheets and printouts, whenever printouts have been made to comply with Article 9 of Section 4 of Part B of this Annex, in chronological order and in a legible form, for at least a year after their use, and shall give copies to the drivers concerned who request them. Road haulage operators shall also give copies of data downloaded from driver cards to the drivers concerned who request them, together with printed paper versions of those copies. Record sheets, printouts and downloaded data shall be produced or handed over at the request of any authorised control officer. 3. Road haulage operators shall be liable for infringements of this Section and of Section 4 of Part B of this Annex committed by their drivers or by drivers at their disposal. However, each Party may make such liability conditional on the road haulage operator's infringement of the first subparagraph of paragraph 1 of this Article and Article 7(1) and (2) of Section 2 of Part B of this Annex. Article 16 Procedures for road haulage operators in the event of malfunctioning equipment 1. In the event of the breakdown or faulty operation of a tachograph, the road haulage operator shall have it repaired by an approved fitter or workshop, as soon as circumstances permit. 2. If the vehicle is unable to return to the road haulage operator's premises within a period of one week calculated from the day of the breakdown or of the discovery of defective operation, the repair shall be carried out en route. 3. Each Party or, in the case of the Union, the Member States shall give the competent authorities power to prohibit the use of the vehicle in cases where the breakdown or faulty operation has not been remedied as provided in paragraphs 1 and 2 in so far as this is in accordance with the national legislation in the Party concerned. Article 17 Procedure for the issuing of tachograph cards The European Commission shall provide to the competent authorities of the United Kingdom the cryptographic material for the issuing of tachograph cards for drivers, workshops and control authorities, in accordance with the European Root Certification Authority (ERCA) certificate policy and the certificate policy of the United Kingdom. (1) Established by Regulation (EU) No 1024/2012 of the European Parliament and of the Council of 25 October 2012 on administrative cooperation through the Internal Market Information System and repealing Commission Decision 2008/49/EC ("the IMI Regulation") (OJ EU L 316, 14.11.2012, p. 1). (2) Regulation (EU) No 1024/2012 of the European Parliament and of the Council of 25 October 2012 on administrative cooperation through the Internal Market Information System and repealing Commission Decision 2008/49/EC ("the IMI Regulation") (OJ EU L 316, 14.11.2012, p. 1). (3) Regulation (EU) No 165/2014 of the European Parliament and of the Council of 4 February 2014 on tachographs in road transport, repealing Council Regulation (EEC) No 3821/85 on recording equipment in road transport and amending Regulation (EC) No 561/2006 of the European Parliament and of the Council on the harmonisation of certain social legislation relating to road transport (OJ EU L 60, 28.2.2014, p. 1). (4) Commission Implementing Regulation (EU) 2016/799 of 18 March 2016 implementing Regulation (EU) No 165/2014 of the European Parliament and of the Council laying down the requirements for the construction, testing, installation, operation and repair of tachographs and their components (OJ EU L 139, 26.5.2016, p. 1). (5) Regulation (EU) No 165/2014 of the European Parliament and of the Council of 4 February 2014 on tachographs in road transport, repealing Council Regulation (EEC) No 3821/85 on recording equipment in road transport and amending Regulation (EC) No 561/2006 of the European Parliament and of the Council on the harmonisation of certain social legislation relating to road transport (OJ EU L 60, 28.2.2014, p. 1). (6) Council Regulation (EC) No 2135/98 of 24 September 1998 amending Regulation (EEC) No 3821/85 on recording equipment in road transport and Directive 88/599/EEC concerning the application of Regulations (EEC) No 3820/84 and (EEC) No 3821/85 (OJ EC L 274, 9.10.1998, p. 1). (7) Commission Implementing Regulation (EU) 2016/68 of 21 January 2016 on common procedures and specifications necessary for the interconnection of electronic registers of driver cards (OJ EU L 15, 22.1.2016, p. 51). ANNEX 32 MODEL OF AUTHORISATION FOR AN INTERNATIONAL REGULAR AND SPECIAL REGULAR SERVICE (First page of authorisation) (Orange paper – DIN A4) (To be worded in the official language(s) or one of the official languages of the Party where the request is made) Authorisation In accordance with Title II of Heading Three of Part Two of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, ISSUING STATE: … Authorising authority: … Issuing State distinguishing sign: … (1) AUTHORISATION No.: … for a regular service ☐ ( 2 ) for a special regular service ☐ (2) by coach and bus between the Parties to the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, To: … … Last name, first name or trade name of the operator or of the managing operator in the case of a group of undertakings or in the case of a partnership: Address: … … Telephone and fax or e-mail: … … (Second page of authorisation) Name, address, telephone and fax or e-mails of the operator, or, in the case of groups of operators or partnerships, the names of all operators of the group or of the partnership; in addition, names of any subcontractors, to be identified as such: (1) … (2) … (3) … (4) … (5) … List attached, if appropriate Validity of the authorisation: From: … To: … Place and date of issue: … Signature and stamp of the issuing authority or agency: … 1. Route: … … (a) Place of departure of service: … … (b) Place of destination of service: … … Principal itinerary, with passenger pick-up and set-down points underlined: … … 2. Timetable: … (attached to this authorisation) 3. Special regular service: (a) Category of passengers: … … 4. Other conditions or special points … … … Stamp of authority issuing the authorisation Important notice: (1) This authorisation is valid for the entire journey. (2) The authorisation or a true copy certified by the issuing authorising authority shall be kept on the vehicle for the duration of the journey and shall be presented to enforcement officials on request. (3) The departure or destination shall take place in the territory of the Party where the operator is established and the coaches and buses registered. (Third page of authorisation) GENERAL CONSIDERATIONS (1) The road passenger transport operator shall begin the transport service within the period indicated in the decision of the authorising authority granting the authorisation. (2) Except in the event of force majeure, the operator of an international regular or special regular service shall take all measures to guarantee a transport service that complies with the conditions as stipulated in the authorisation. (3) The operator shall make the information about the route, the stopping points, the timetable, the fares and the conditions of transport publicly available. (4) Without prejudice to documents pertaining to the vehicle and driver (such as the vehicle registration certificate and driving licence), the following documents shall serve as control documents required under Article 477 of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part and shall be kept in the vehicle and presented at the request of any authorised inspecting officer: — the authorisation or a certified true copy thereof to carry out international regular or special regular services; — the operator's licence or a certified true copy thereof for the international carriage of passengers by road provided for according to the United Kingdom or Union legislation; — when operating an international special regular service, the contract between the organiser and the transport operator or a certified true copy thereof as well as a document evidencing that the passengers constitute a specific category to the exclusion of other passengers for the purposes of a special regular service; — when the operator of a regular or special regular service uses additional vehicles to deal with temporary and exceptional situations, in addition to the relevant documents mentioned above, a copy of the contract between the operator of the international regular or special regular service and the undertaking providing the additional vehicles or an equivalent document. (Fourth page of authorisation) GENERAL CONSIDERATIONS (cont.) (5) Operators operating an international regular service, with the exclusion of special regular service, shall issue transport tickets confirming the rights of the passenger to be transported and serving as a control document evidencing of the conclusion of the contract of carriage between the passenger and the transport operator, either individual or collective. The tickets that can also be electronic shall indicate: (a) the name of the operator; (b) the points of departure and destination and, if applicable, the return journey; (c) the period of validity of the ticket and, if applicable, the date and time of departure; (d) the price of transport. The transport ticket shall be presented, by the passenger, at the request of any authorised inspection officer. (6) Operators operating international regular or special regular passenger transport services shall allow all inspections intended to ensure that operations are being conducted correctly, in particular as regards driving and rest periods and road safety and emissions. (1) Austria (A), Belgium (B), Bulgaria (BG), Cyprus (CY), Croatia (HR), Czech Republic (CZ), Denmark (DK), Estonia (EST), Finland (FIN), France (F), Germany (D), Greece (GR), Hungary (H), Ireland (IRL), Italy (I), Latvia (LV), Lithuania (LT), Luxembourg (L), Malta (MT), Netherlands (NL), Poland (PL), Portugal (P), Romania (RO), Slovak Republic (SK), Slovenia (SLO), Spain (E), Sweden (S), United Kingdom (UK), to be completed/ (2) Tick or complete as appropriate. ANNEX 33 MODEL OF APPLICATION FOR AN AUTHORISATION FOR AN INTERNATIONAL REGULAR AND SPECIAL REGULAR SERVICE (White paper – DIN A4) (To be worded in the official language(s) or one of the official languages of the Party where the request is made) APPLICATION FORM FOR AN AUTHORISATION OR RENEWAL OF AN AUTHORISATION TO CARRY OUT AN INTERNATIONAL REGULAR SERVICE OR AN INTERNATIONAL SPECIAL REGULAR SERVICE (1) To start a regular service ☐ To start a special regular service ☐ To renew authorisation for a service ☐ To alter the conditions of authorisation for a service ☐ carried out by coach and bus between Parties in accordance with the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, … (Authorising authority) 1. Name and first name or trade name of the applicant operator; in the case of an application by a group of operators or by a partnership, the name of the operator entrusted by the other operators for the purposes of submitting the application: … … 2. Services to be carried out(1) By an operator ☐ by a group of operators ☐ by a partnership ☐ by a subcontractor ☐ 3. Names and addresses of the operator or, in the case of a group of operators or of a partnership, the names of all operators of the group or of the partnership; in addition, any subcontractors shall be identified by their names (2) 3.1 …. tel. … 3.2 …. tel. … 3.3 …. tel. … 3.4 …. tel. … (Second page of the application for authorisation or renewal of authorisation) 4 In the case of a special regular service: 4.1 Category of passengers: (3) workers ☐ school pupils/students ☐ other ☐ 5 Duration of authorisation requested or date on which the service ends: … 6 Principal route of service (underline passenger pick-up and set-down points, with full addresses): (4) … … … 7 Period of operation: … … … 8 Frequency (daily, weekly, etc.): … 9 Fares … Annex attached. 10 Enclose a driving schedule to permit verification of compliance with the international rules on driving times and rest time periods. 11 Number of authorisations or of certified true copies of authorisations requested: (5) … 12 Any additional information: … (Place and date) (Signature of applicant) … The attention of the applicant is drawn to the fact that, since the authorisation or its certified true copy has to be kept on board the vehicle, the number of authorisations or certified true copies, issued by the authorising authority, which the applicant must have should correspond to the number of vehicles needed for carrying out the service requested at the same time. Important notice In particular the following must be attached to the application: (a) the timetable including the time slots for controls at relevant border crossings; (b) a certified true copy of the operator's (or operators') licence(s) for the international carriage of passengers by road provided for according to national or Union legislation; (c) a map on an appropriate scale on which are marked the route and the stopping points at which passengers are to be taken up or set down; (d) a driving schedule to permit verification of compliance with the international rules on driving times and rest periods; (e) any appropriate information concerning coach and bus terminals. (1) Tick or complete as appropriate. (2) Attach list if applicable. (3) Tick or complete as appropriate. (4) The authorising authority may request a full list of passenger pick-up and set-down points with full addresses to be attached separately to this application form. (5) Complete as appropriate/ ANNEX 34 MODEL OF JOURNEY FORM FOR OCCASIONAL SERVICES JOURNEY FORM No … of Book No … (colour Pantone 358 (light green), or as close as possible to this colour, format DIN A4 uncoated paper) OCCASIONAL SERVICES WITH CABOTAGE AND OCCASIONAL SERVICES WITH TRANSIT (Each item, if necessary, can be supplemented on a separate sheet) 1 Registration number of the coach … Place, date and signature of the carrier 2 1. … 2. … 3. … Carrier and, where appropriate, subcontractor or group of carriers 3 1. … 2. … 3. … Name of driver(s) 4 Organisation of person responsible for the occasional service 1. … 2. … 3. … 4. …. 5 Type of service ☐ Occasional service with cabotage ☐ Occasional service with transit 6 Place of departure of service: … Country: … Place of destination of service: … Country: … 7 Journey Route/Daily stages and/or passenger pick-up or set-down points Number of passengers Empty (mark with an X ) Planned km Dates From To 8 Connection points, if any, with another carrier in the same group Number of passengers set down Final destination of the passengers set down Carrier picking up the passengers 9 Unforeseen changes … … ANNEX 35 # Code Common Name ICES Areas Shares 2021 2022 2023 2024 2025 2026 onwards EU UK EU UK EU UK EU UK EU UK EU UK 1 ALF/3X14- Alfonsinos (3,4,5,6,7,8,9, 10,12,14) UK, Union and international waters of 3, 4, 5, 6, 7, 8, 9, 10, 12 and 14 96.95 3.05 96.95 3.05 96.95 3.05 96.95 3.05 96.95 3.05 96.95 3.05 2 ANF/07. Anglerfish (7) 7 78.78 21.22 78.24 21.76 77.70 22.30 77.05 22.95 76.62 23.38 76.62 23.38 3 ANF/2AC4-C Anglerfish (North Sea) UK and Union waters 4; UK waters of 2a 13.74 86.26 12.92 87.08 12.11 87.89 11.13 88.87 10.48 89.52 10.48 89.52 4 ANF/56-14 Anglerfish (West of Scotland) 6; UK and international waters of 5b; international waters of 12 and 14 60.99 39.01 59.62 40.38 58.25 41.75 56.60 43.40 55.50 44.50 55.50 44.50 5 ARU/1/2. Greater Silver Smelt (1,2) UK and international waters of 1 and 2 56.90 43.10 56.90 43.10 56.90 43.10 56.90 43.10 56.90 43.10 56.90 43.10 6 ARU/3A4-C Greater Silver Smelt (North Sea) UK and Union waters of 4; Union waters of 3a 98.40 1.60 98.40 1.60 98.40 1.60 98.40 1.60 98.40 1.60 98.40 1.60 7 ARU/567. Greater Silver Smelt (Western) 6 and 7; UK and international waters of 5 94.41 5.59 94.41 5.59 94.41 5.59 94.41 5.59 94.41 5.59 94.41 5.59 8 BLI/12INT- Blue Ling (International 12) International waters of 12 99.14 0.86 99.14 0.86 99.14 0.86 99.14 0.86 99.14 0.86 99.14 0.86 9 BLI/24- Blue Ling (North Sea) UK and international waters of 2; UK and Union waters of 4 73.19 26.81 73.19 26.81 73.19 26.81 73.19 26.81 73.19 26.81 73.19 26.81 10 BLI/5B67- Blue Ling (Western) 6 and 7; UK and international waters of 5 77.31 22.69 76.73 23.27 76.16 23.84 75.46 24.54 75.00 25.00 75.00 25.00 11 BOR/678- Boarfish (Western) 6, 7 and 8 93.65 6.36 93.65 6.36 93.65 6.36 93.65 6.36 93.65 6.36 93.65 6.36 12 BSF/56712- Black Scabbardfish (Western) 6 and 7; UK and international waters of 5; international waters of 12 94.31 5.69 94.31 5.69 94.31 5.69 94.31 5.69 94.31 5.69 94.31 5.69 13 COD/07A. Cod (Irish Sea) 7a 56.05 43.95 55.84 44.16 55.63 44.37 55.37 44.63 55.20 44.80 55.20 44.80 14 COD/07D. Cod (Eastern Channel) 7d 90.75 9.25 90.75 9.25 90.75 9.25 90.75 9.25 90.75 9.25 90.75 9.25 15 COD/5BE6A Cod (West of Scotland) 6a; UK and international waters of 5b east of 12°00' W 30.23 69.77 27.37 72.63 24.51 75.49 21.08 78.92 18.79 81.21 18.79 81.21 16 COD/5W6-14 Cod (Rockall) 6b; UK and international waters of 5b west of 12°00' W and of 12 and 14 33.95 66.05 31.71 68.29 29.47 70.53 26.78 73.22 24.99 75.01 24.99 75.01 17 COD/7XAD34 Cod (Celtic Sea) 7b, 7c, 7e-k, 8, 9 and 10; Union waters of CECAF 34.1.1 90.70 9.30 90.47 9.53 90.23 9.77 89.95 10.05 89.76 10.24 89.76 10.24 18 DGS/15X14 Spurdog (Western) 6, 7 and 8; UK and international waters of 5; international waters of 1, 12 and 14 57.53 42.47 56.61 43.39 55.69 44.31 54.58 45.42 53.84 46.16 53.84 46.16 19 DWS/56789- Deep-sea Sharks (Western) 6, 7, 8 and 9; UK and international waters of 5 100.00 0.00 100.00 0.00 100.00 0.00 100.00 0.00 100.00 0.00 100.00 0.00 20 HAD/07A. Haddock (Irish Sea) 7a 47.24 52.76 46.42 53.58 45.61 54.39 44.63 55.37 43.98 56.02 43.98 56.02 21 HAD/5BC6A. Haddock (West of Scotland) 6a; UK and international waters of 5b 19.39 80.61 19.39 80.61 19.39 80.61 19.39 80.61 19.39 80.61 19.39 80.61 22 HAD/6B1214 Haddock (Rockall) UK, Union and international waters of 6b; international waters 12 and 14 16.76 83.24 16.32 83.68 15.88 84.12 15.35 84.65 15.00 85.00 15.00 85.00 23 HAD/7X7A34 Haddock (Celtic Sea) 7b-k, 8, 9 and 10; Union waters of CECAF 34.1.1 84.00 16.00 83.00 17.00 82.00 18.00 80.80 19.20 80.00 20.00 80.00 20.00 24 HER/07A/MM Herring (Irish Sea) 7a north of 52°30’N 11.01 88.99 8.50 91.50 6.00 94.00 2.99 97.01 0.99 99.01 0.99 99.01 25 HER/5B6ANB Herring (West of Scotland) 6b and 6aN; UK and international waters 5b 35.95 64.05 35.34 64.66 34.74 65.26 34.01 65.99 33.53 66.47 33.53 66.47 26 HER/7EF. Herring (Western Channel and Bristol Channel) 7e and 7f 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 27 HER/7G-K. Herring (Celtic Sea) 7a south of 52°30’N, 7g, 7h, 7j and 7k 99.88 0.12 99.88 0.12 99.88 0.12 99.88 0.12 99.88 0.12 99.88 0.12 28 HKE/2AC4-C Hake (North Sea) UK and Union waters 4; UK waters of 2a 60.67 39.33 57.11 42.89 53.56 46.44 49.29 50.71 46.45 53.55 46.45 53.55 29 HKE/571214 Hake (Western) 6 and 7; UK and international waters of 5b; international waters of 12 and 14 80.33 19.67 80.05 19.95 79.77 20.23 79.43 20.57 79.20 20.80 79.20 20.80 30 JAX/2A-14 Horse Mackerel (Western) UK and Union waters of 4a; 6, 7a-c, e-k; 8a-b, d-e; UK and international waters of 2a and 5b; international waters of 12 and 14 90.61 9.39 90.61 9.39 90.61 9.39 90.61 9.39 90.61 9.39 90.61 9.39 31 JAX/4BC7D Horse Mackerel (Southern North Sea and Eastern Channel) UK and Union waters of 4b, 4c and 7d 71.46 28.54 68.60 31.40 65.73 34.27 62.29 37.71 60.00 40.00 60.00 40.00 32 L/W/2AC4-C Lemon Sole and Witch (North Sea)* UK and Union waters of 4; UK waters of 2a 35.97 64.03 35.48 64.52 34.98 65.02 34.39 65.61 34.00 66.00 34.00 66.00 33 LEZ/07. Megrims (7) 7 81.37 18.63 80.65 19.35 79.93 20.07 79.07 20.93 78.50 21.50 78.50 21.50 34 LEZ/2AC4-C Megrims (North Sea) UK and Union waters 4; UK waters of 2a 3.74 96.26 3.74 96.26 3.74 96.26 3.74 96.26 3.74 96.26 3.74 96.26 35 LEZ/56-14 Megrims (West of Scotland) 6; UK and international waters of 5b; international waters of 12 and 14 60.84 39.16 59.55 40.45 58.25 41.75 56.69 43.31 55.65 44.35 55.65 44.35 36 LIN/03A-C. Ling (3a) Union waters of 3a 92.65 7.35 92.65 7.35 92.65 7.35 92.65 7.35 92.65 7.35 92.65 7.35 37 LIN/04-C. Ling (North Sea) UK and Union waters of 4 21.22 78.78 20.92 79.08 20.61 79.39 20.24 79.76 20.00 80.00 20.00 80.00 38 LIN/6X14. Ling (Western) 6, 7, 8, 9 and 10; international waters of 12 and 14 63.67 36.33 63.25 36.75 62.83 37.17 62.33 37.67 62.00 38.00 62.00 38.00 39 NEP/*07U16 Nephrops (Porcupine Bank) Functional Unit 16 of ICES Subarea 7 85.32 14.68 85.32 14.68 85.32 14.68 85.32 14.68 85.32 14.68 85.32 14.68 40 NEP/07. Nephrops (7) 7 61.68 38.32 60.76 39.24 59.84 40.16 58.74 41.26 58.00 42.00 58.00 42.00 41 NEP/2AC4-C Nephrops (North Sea) UK and Union waters 4; UK waters of 2a 13.38 86.62 13.38 86.62 13.38 86.62 13.38 86.62 13.38 86.62 13.38 86.62 42 NOP/2A3A4. Norway Pout (North Sea) 3a; UK and Union waters and 4; UK waters of 2a 85.00 15.00 82.50 17.50 80.00 20.00 77.00 23.00 75.00 25.00 75.00 25.00 43 PLE/07A. Plaice (Irish Sea) 7a 48.89 51.11 48.89 51.11 48.89 51.11 48.89 51.11 48.89 51.11 48.89 51.11 44 PLE/56-14 Plaice (West of Scotland) 6; UK and international waters of 5b; international waters of 12 and 14 39.23 60.77 39.23 60.77 39.23 60.77 39.23 60.77 39.23 60.77 39.23 60.77 45 PLE/7DE. Plaice (English Channel)* 7d and 7e 70.36 29.64 70.27 29.73 70.18 29.82 70.07 29.93 70.00 30.00 70.00 30.00 46 PLE/7FG. Plaice (7fg) 7f and 7g 74.86 25.14 74.58 25.42 74.30 25.70 73.96 26.04 73.74 26.26 73.74 26.26 47 PLE/7HJK. Plaice (7hjk) 7h, 7j and 7k 84.25 15.75 83.71 16.29 83.17 16.83 82.52 17.48 82.09 17.91 82.09 17.91 48 POK/56-14 Saithe (West of Scotland) 6; UK and international waters of 5b, 12 and 14 62.32 37.68 58.99 41.01 55.66 44.34 51.66 48.34 49.00 51.00 49.00 51.00 49 POK/7/3411 Saithe (Celtic Sea) 7, 8, 9 and 10; Union waters of CECAF 34.1.1 84.86 15.14 84.90 15.10 84.93 15.07 84.97 15.03 85.00 15.00 85.00 15.00 50 POL/07. Pollack (7) 7 78.03 21.97 77.27 22.73 76.51 23.49 75.61 24.39 75.00 25.00 75.00 25.00 51 POL/56-14 Pollack (West of Scotland) 6; UK and international waters of 5b; international waters of 12 and 14 63.38 36.62 63.38 36.62 63.38 36.62 63.38 36.62 63.38 36.62 63.38 36.62 52 PRA/2AC4-C Northern Prawn (North Sea) UK and Union waters 4; UK waters of 2a 77.99 22.01 77.99 22.01 77.99 22.01 77.99 22.01 77.99 22.01 77.99 22.01 53 RJE/7FG. Small-eyed Ray (7fg) 7f and 7g 56.36 43.64 53.39 46.61 50.42 49.58 46.86 53.14 44.49 55.51 44.49 55.51 54 RJU/7DE. Undulate Ray (English Channel) 7d and 7e 69.12 30.88 68.09 31.91 67.06 32.94 65.82 34.18 65.00 35.00 65.00 35.00 55 RNG/5B67- Roundnose Grenadier (Western) 6 and 7; UK and international waters of 5b 95.16 4.84 95.16 4.84 95.16 4.84 95.16 4.84 95.16 4.84 95.16 4.84 56 RNG/8X14- Roundnose Grenadier (8,9,10,12,14) 8, 9 and 10; international waters of 12 and 14 99.71 0.29 99.71 0.29 99.71 0.29 99.71 0.29 99.71 0.29 99.71 0.29 57 SAN/2A3A4. Sandeels (North Sea, All Banks) UK and Union waters of 4; UK waters of 2a; Union waters of 3a 97.26 2.74 97.14 2.86 97.03 2.97 96.89 3.11 96.80 3.20 96.80 3.20 58 SBR/678- Red Seabream (Western) 6, 7 and 8 90.00 10.00 90.00 10.00 90.00 10.00 90.00 10.00 90.00 10.00 90.00 10.00 59 SOL/07A. Sole (Irish Sea) 7a 77.15 22.86 77.03 22.97 76.92 23.08 76.79 23.21 76.70 23.30 76.70 23.30 60 SOL/07D. Sole (Eastern Channel) 7d 80.31 19.69 80.23 19.77 80.15 19.85 80.06 19.94 80.00 20.00 80.00 20.00 61 SOL/07E. Sole (Western Channel) 7e 38.97 61.03 38.60 61.40 38.24 61.76 37.79 62.21 37.50 62.50 37.50 62.50 62 SOL/24-C. Sole (North Sea) UK and Union waters 4; UK waters of 2a 88.09 11.91 86.81 13.19 85.54 14.46 84.02 15.98 83.00 17.00 83.00 17.00 63 SOL/56-14 Sole (West of Scotland) 6; UK and international waters of 5b; international waters of 12 and 14 80.00 20.00 80.00 20.00 80.00 20.00 80.00 20.00 80.00 20.00 80.00 20.00 64 SOL/7FG. Sole (7fg) 7f and 7g 69.35 30.65 68.93 31.07 68.51 31.49 68.01 31.99 67.67 32.33 67.67 32.33 65 SOL/7HJK. Sole (7hjk) 7h, 7j and 7k 83.33 16.67 83.33 16.67 83.33 16.67 83.33 16.67 83.33 16.67 83.33 16.67 66 SPR/2AC4-C Sprat (North Sea) UK and Union waters 4; UK waters of 2a 96.18 3.82 96.18 3.82 96.18 3.82 96.18 3.82 96.18 3.82 96.18 3.82 67 SPR/7DE. Sprat (English Channel) 7d and 7e 28.60 71.40 25.45 74.55 22.30 77.70 18.52 81.48 16.00 84.00 16.00 84.00 68 SRX/07D. Skates and Rays (Eastern Channel) 7d 84.51 15.49 84.44 15.56 84.36 15.64 84.27 15.73 84.21 15.79 84.21 15.79 69 SRX/2AC4-C Skates and Rays (North Sea) UK and Union waters 4; UK waters of 2a 32.73 67.27 32.29 67.71 31.86 68.14 31.35 68.65 31.00 69.00 31.00 69.00 70 SRX/67AKXD Skates and Rays (Western) UK and Union waters of 6a, 6b, 7a-c and 7e-k 71.06 28.94 70.54 29.46 70.02 29.98 69.40 30.60 68.99 31.01 68.99 31.01 71 T/B/2AC4-C Turbot and Brill (North Sea)* UK and Union waters of 4; UK waters of 2a 81.82 18.18 81.37 18.63 80.91 19.09 80.36 19.64 80.00 20.00 80.00 20.00 72 USK/04-C. Tusk (North Sea) UK and Union waters of 4 59.46 40.54 59.46 40.54 59.46 40.54 59.46 40.54 59.46 40.54 59.46 40.54 73 USK/567EI. Tusk (Western) 6 and 7; UK and international waters of 5 70.73 29.27 70.55 29.45 70.37 29.63 70.15 29.85 70.00 30.00 70.00 30.00 74 WHG/07A. Whiting (Irish Sea) 7a 42.27 57.73 41.45 58.55 40.63 59.37 39.65 60.35 39.00 61.00 39.00 61.00 75 WHG/56-14 Whiting (West of Scotland) 6; UK and international waters of 5b; international waters of 12 and 14 37.53 62.47 36.67 63.33 35.81 64.19 34.78 65.22 34.09 65.91 34.09 65.91 76 WHG/7X7A-C Whiting (Celtic Sea)* 7b, 7c, 7d, 7e, 7f, 7g, 7h, 7j and 7k 88.95 11.05 88.89 11.11 88.84 11.16 88.77 11.23 88.73 11.27 88.73 11.27 ANNEX 36 A. UK-EU-NO trilateral stocks # Code Common Name ICES Areas Shares 2021 2022 2023 2024 2025 2026 onwards EU UK EU UK EU UK EU UK EU UK EU UK 77 COD/2A3AX4 Cod (North Sea) 4; UK waters of 2a; that part of 3a not covered by the Skagerrak and Kattegat 47.03 52.97 46.02 53.98 45.02 54.99 43.81 56.19 43.00 57.00 43.00 57.00 78 HAD/2AC4. Haddock (North Sea) 4; UK waters of 2a 18.45 81.55 17.80 82.20 17.14 82.86 16.35 83.65 15.83 84.17 15.83 84.17 79 HER/2A47DX Herring (North Sea bycatch) 4 and 7d; UK waters of 2a 98.18 1.82 98.18 1.82 98.18 1.82 98.18 1.82 98.18 1.82 98.18 1.82 80 HER/4AB. Herring (North Sea) UK, Union and Norwegian waters of 4 north of 53° 30' N 71.33 28.67 70.42 29.58 69.50 30.50 68.41 31.59 67.68 32.32 67.68 32.32 81 HER/4CXB7D Herring (Southern North Sea and Eastern Channel) 4c, 7d excluding Blackwater 88.76 11.24 88.48 11.52 88.21 11.79 87.87 12.13 87.65 12.35 87.65 12.35 82 PLE/2A3AX4 Plaice (North Sea) 4; UK waters of 2a; that part of 3a not covered by the Skagerrak and the Kattegat 71.54 28.46 71.54 28.46 71.54 28.46 71.54 28.46 71.54 28.46 71.54 28.46 83 POK/2C3A4 Saithe (North Sea) 3a and 4; UK waters of 2a 77.71 22.29 76.78 23.22 75.85 24.15 74.74 25.26 74.00 26.00 74.00 26.00 84 WHG/2AC4. Whiting (North Sea) 4; UK waters of 2a 34.78 65.22 32.71 67.29 30.63 69.37 28.13 71.87 26.47 73.53 26.47 73.53 B. Coastal States Stocks # Code Common Name ICES Areas Shares 2021 2022 2023 2024 2025 2026 onwards EU UK EU UK EU UK EU UK EU UK EU UK 85 MAC/2A34. Mackerel (North Sea) 3a and 4; UK waters of 2a; Union waters of 3b, 3c and Subdivisions 22-32 93.91 6.09 93.78 6.22 93.65 6.35 93.50 6.50 93.40 6.60 93.40 6.60 86 MAC/2CX14- Mackerel (Western) 6, 7, 8a, 8b, 8d and 8e; UK and international waters of 5b; international waters of 2a, 12 and 14 35.15 64.85 34.06 65.94 32.98 67.02 31.67 68.33 30.80 69.20 30.80 69.20 87 WHB/1X14 Blue Whiting (Northern) UK, Union and international waters of 1, 2, 3, 4, 5, 6, 7, 8a, 8b, 8d, 8e, 12 and 14 79.47 20.53 79.35 20.65 79.24 20.76 79.09 20.91 79.00 21.00 79.00 21.00 C. ICCAT Stocks # Code Common Name Area Shares EU UK 88 ALB/AN05N Albacore (North Atlantic) Atlantic Ocean, north of 5° N 98.48 1.52 89 BFT/AE45WM Bluefin Tuna (Northeast Atlantic) Atlantic Ocean, east of 45° W, and Mediterranean 99.75 0.25 90 BSH/AN05N Blue Shark (North Atlantic) Atlantic Ocean, north of 5° N 99.90 0.10 91 SWO/AN05N Swordfish (North Atlantic) Atlantic Ocean, North of 5° N 99.99 0.01 D. NAFO Stocks # Code Common Name Area Shares EU UK 92 COD/N3M. Cod (NAFO 3M) NAFO 3M 83.66 16.34 E. Special Cases # Code Common Name ICES Areas Shares EU UK 93 COD/1/2B. Cod (Svalbard) 1 and 2b 75.00 25.00 F. Stocks that are only present in one Party's waters # Code Common Name ICES Areas Shares EU UK 94 GHL/2A C46 Greenland Halibut (North Sea and West of Scotland) 6; UK and Union waters of 4; UK waters of 2a; UK and international waters of 5b 27.35 72.65 95 HER/06ACL. Herring (Clyde) 6 Clyde 0.00 100.00 96 HER/1/2- Herring (ASH) UK, Faroese, Norwegian and international waters of 1 and 2 70.00 30.00 97 LIN/05EI. Ling (5) UK and international waters of 5 81.48 18.52 98 LIN/1/2. Ling (1,2) UK and international waters of 1 and 2 77.78 22.22 99 NEP/5BC6. Nephrops (West of Scotland) 6; UK and international waters of 5b 2.36 97.64 100 RED/51214D Redfish [Deep Pelagic] (5,12,14) UK and international waters of 5; international waters of 12 and 14 98.00 2.00 101 RED/51214S Redfish [Shallow Pelagic] (5,12,14) UK and international waters of 5; international waters of 12 and 14 98.00 2.00 102 SBR/10- Red Seabream (Azores) Union and international waters of 10 99.12 0.88 103 SRX/89-C. Skates and Rays (8,9) UK and Union waters of 8; Union waters of 9 99.78 0.22 104 USK/1214EI Tusk (1,2,14) UK and international waters of 1, 2 and 14 71.43 28.57 ANNEX 37 # Stock Code Common Name ICES Areas 105 ANF/8ABDE. Anglerfish (8) 8a, 8b, 8d and 8e 106 BLI/03A- Blue Ling (3a) Union waters of 3a 107 BSF/8910- Black Scabbardfish (8,9,10) 8, 9 and 10 108 COD/03AN. Cod (Skagerrak) Skagerrak 109 HAD/03A. Haddock (3a) 3a 110 HER/03A. Herring (3a) 3a 111 HER/03A-BC Herring (3a bycatch) 3a 112 HER/6AS7BC Herring (West of Ireland) 6aS, 7b and 7c 113 HKE/03A. Hake (3a) 3a 114 HKE/8ABDE. Hake (8) 8a, 8b, 8d and 8e 115 JAX/08C. Horse Mackerel (8c) 8c 116 LEZ/8ABDE. Megrims (8) 8a, 8b, 8d and 8e 117 MAC/2A4A-N Mackerel (Denmark allocation in Norwegian waters) Norwegian waters of 2a and 4a 118 MAC/8C3411 Mackerel (Southern Component) 8c, 9 and 10; Union waters of CECAF 34.1.1 119 PLE/03AN. Plaice (Skagerrak) Skagerrak 120 SPR/03A. Sprat (3a) 3a 121 SRX/03A-C. Skates and Rays (3a) Union waters of 3a 122 USK/03A. Tusk (3a) 3a 123 WHB/8C3411 Blue Whiting (Southern Component) 8c, 9 and 10; Union waters of CECAF 34.1.1 ANNEX 38 PROTOCOL ON ACCESS TO WATERS The United Kingdom and the Union AFFIRMING the sovereign rights and obligations of independent coastal States exercised by the Parties; EMPHASISING that the right of each Party to grant vessels of the other Party access to fish in its waters is ordinarily to be exercised in annual consultations following the determination of TACs for a given year in annual consultations; NOTING the social and economic benefits of a further period of stability, during which fishers would be permitted until 30 June 2026 to continue to access the waters of the other Party as before the entry into force of this Agreement; HAVE AGREED as follows: Article 1 An adjustment period is hereby established. The adjustment period shall last from 1 January 2021 until 30 June 2026. Article 2 1. By way of derogation from Article 500(1), (3), (4), (5), (6) and (7) of this Agreement, during the adjustment period each Party shall grant to vessels of the other Party full access to its waters to fish: (a) stocks listed in Annex 35 and in tables A, B and F of Annex 36 at a level that is reasonably commensurate with the Parties’ respective shares of the fishing opportunities; (b) non quota stocks at a level that equates to the average tonnage fished by that Party in the waters of the other Party during the period 2012-2016; (c) for qualifying vessels to the zone in the waters of the Parties between six and twelve nautical miles from the baselines in ICES divisions 4c and 7d-g to the extent that each Party's qualifying vessels had access to that zone on 31 December 2020. For the purposes point (c), "qualifying vessel" means a vessel of a Party, which fished in the zone mentioned in the previous sentence in at least four years between 2012 and 2016, or its direct replacement. 2. The Parties shall notify the other Party of any change in the level and conditions of access to waters that will apply from 1 July 2026. 3. Article 501 of this Agreement shall apply mutatis mutandis in relation to any change under paragraph 2 of this Article in respect of the period from 1 July 2026 to 31 December 2026. ANNEX 39 EXCHANGES OF DNA, FINGERPRINTS AND VEHICLE REGISTRATION DATA CHAPTER 0 GENERAL PROVISIONS Article 1 Aim The aim of this Annex is to lay down the necessary data protection, administrative and technical provisions for the implementation of Title II of Part Three of this Agreement. Article 2 Technical specifications States shall observe common technical specifications in connection with all requests and answers related to searches and comparisons of DNA profiles, dactyloscopic data and vehicle registration data. These technical specifications are laid down in Chapters 1 to 3. Article 3 Communications network The electronic exchange of DNA data, dactyloscopic data and vehicle registration data between States shall take place using the Trans European Services for Telematics between Administrations (TESTA II) communications network and further developments thereof. Article 4 Availability of automated data exchange States shall take all necessary measures to ensure that automated searching or comparison of DNA data, dactyloscopic data and vehicle registration data is possible 24 hours a day and seven days a week. In the event of a technical fault, the States' national contact points shall immediately inform each other and shall agree on temporary alternative information exchange arrangements in accordance with the legal provisions applicable. Automated data exchange shall be re-established as quickly as possible. Article 5 Reference numbers for DNA data and dactyloscopic data The reference numbers referred to in Articles 529 and 533 of this Agreement shall consist of a combination of the following: (a) a code allowing the States, in the case of a match, to retrieve personal data and other information in their databases in order to supply it to one, several or all of the States in accordance with Article 536 of this Agreement; (b) a code to indicate the national origin of the DNA profile or dactyloscopic data; and (c) with respect to DNA data, a code to indicate the type of DNA profile. Article 6 Principles of DNA data exchange 1. States shall use existing standards for DNA data exchange, such as the European Standard Set (ESS) or the Interpol Standard Set of Loci (ISSOL). 2. The transmission procedure, in the case of automated searching and comparison of DNA profiles, shall take place within a decentralised structure. 3. Appropriate measures shall be taken to ensure confidentiality and integrity of data being sent to other States, including their encryption. 4. States shall take the necessary measures to guarantee the integrity of the DNA profiles made available or sent for comparison to the other States and to ensure that those measures comply with international standards such as ISO 17025. 5. States shall use State codes in accordance with the ISO 3166-1 alpha-2 standard. Article 7 Rules for requests and answers in connection with DNA data 1. A request for an automated search or comparison, as referred to in Article 530 or 531 of this Agreement, shall include only the following information: (a) the State code of the requesting State; (b) the date, time and indication number of the request; (c) DNA profiles and their reference numbers; (d) the types of DNA profiles transmitted (unidentified DNA profiles or reference DNA profiles); and (e) information required for controlling the database systems and quality control for the automatic search processes. 2. The answer (matching report) to the request referred to in paragraph 1 shall contain only the following information: (a) an indication as to whether there were one or more matches (HITs) or no matches (No-HITs); (b) the date, time and indication number of the request; (c) the date, time and indication number of the answer; (d) the State codes of the requesting and requested States; (e) the reference numbers of the requesting and requested States; (f) the type of DNA profiles transmitted (unidentified DNA profiles or reference DNA profiles); (g) the requested and matching DNA profiles; and (h) information required for controlling the database systems and quality control for the automatic search processes. 3. Automated notification of a match shall only be provided if the automated search or comparison has resulted in a match of a minimum number of loci. That minimum is set out in Chapter 1. 4. The States shall ensure that requests comply with declarations issued pursuant to Article 529(3) of this Agreement. Article 8 Transmission procedure for automated searching of unidentified DNA profiles in accordance with Article 530 1. If, in a search with an unidentified DNA profile, no match has been found in the national database or a match has been found with an unidentified DNA profile, the unidentified DNA profile may then be transmitted to all other States' databases and if, in a search with this unidentified DNA profile, matches are found with reference DNA profiles and/or unidentified DNA profiles in other States' databases, these matches shall be automatically communicated and the DNA reference data transmitted to the requesting State; if no matches can be found in other States' databases, it shall be automatically communicated to the requesting State. 2. If, in a search with an unidentified DNA profile, a match is found in other States' databases, each State concerned may insert a note to that effect in its national database. Article 9 Transmission procedure for automated search of reference DNA profiles in accordance with Article 530 If, in a search with a reference DNA profile, no match has been found in the national database with a reference DNA profile or a match has been found with an unidentified DNA profile, this reference DNA profile may then be transmitted to all other States' databases and if, in a search with this reference DNA profile, matches are found with reference DNA profiles and/or unidentified DNA profiles in other States' databases, these matches shall be automatically communicated and the DNA reference data transmitted to the requesting State; if no matches can be found in other States' databases, it shall be automatically communicated to the requesting State. Article 10 Transmission procedure for automated comparison of unidentified DNA profiles in accordance with Article 531 1. If, in a comparison with unidentified DNA profiles, matches are found in other States' databases with reference DNA profiles and/or unidentified DNA profiles, these matches shall be automatically communicated and the DNA reference data transmitted to the requesting State. 2. If, in a comparison with unidentified DNA profiles, matches are found in other States' databases with unidentified DNA profiles or reference DNA profiles, each State concerned may insert a note to that effect in its national database. Article 11 Principles for the exchange of dactyloscopic data 1. The digitalisation of dactyloscopic data and their transmission to the other States shall be carried out in accordance with the uniform data format specified in Chapter 2. 2. Each State shall ensure that the dactyloscopic data it transmits are of sufficient quality for a comparison by the automated fingerprint identification systems (AFIS). 3. The transmission procedure for the exchange of dactyloscopic data shall take place within a decentralised structure. 4. Appropriate measures shall be taken to ensure the confidentiality and integrity of dactyloscopic data being sent to other States, including their encryption. 5. The States shall use State codes in accordance with the ISO 3166-1 alpha-2 standard. Article 12 Search capacities for dactyloscopic data 1. Each State shall ensure that its search requests do not exceed the search capacities specified by the requested State. The United Kingdom shall declare their maximum search capacities per day for dactyloscopic data of identified persons and for dactyloscopic data of persons not yet identified. 2. The maximum numbers of candidates accepted for verification per transmission are set out in Chapter 2. Article 13 Rules for requests and answers in connection with dactyloscopic data 1. The requested State shall check the quality of the transmitted dactyloscopic data without delay by a fully automated procedure. Should the data be unsuitable for an automated comparison, the requested State shall inform the requesting State without delay. 2. The requested State shall conduct searches in the order in which requests are received. Requests shall be processed within 24 hours by a fully automated procedure. The requesting State may, if its domestic law so prescribes, ask for accelerated processing of its requests and the requested State shall conduct these searches without delay. If deadlines cannot be met for reasons of force majeure, the comparison shall be carried out without delay as soon as the impediments have been removed. Article 14 Principles of automated searching of vehicle registration data 1. For automated searching of vehicle registration data States shall use a version of the European Vehicle and Driving Licence Information System (Eucaris) software application especially designed for the purposes of Article 537 of this Agreement, and amended versions of that software. 2. Automated searching of vehicle registration data shall take place within a decentralised structure. 3. The information exchanged via the Eucaris system shall be transmitted in encrypted form. 4. The data elements of the vehicle registration data to be exchanged are specified in Chapter 3. 5. In the implementation of Article 537 of this Agreement, States may give priority to searches related to combating serious crime. Article 15 Costs Each State shall bear the costs arising from the administration, use and maintenance of the Eucaris software application referred to in Article 14(1). Article 16 Purpose 1. Processing of personal data by the receiving State shall be permitted solely for the purposes for which the data have been supplied in accordance with Title II of Part Three of this Agreement. Processing for other purposes shall be permitted solely with the prior authorisation of the State administering the file and subject only to the domestic law of the receiving State. Such authorisation may be granted provided that processing for such other purposes is permitted under the domestic law of the State administering the file. 2. Processing of data supplied pursuant to Articles 530, 531 and 534 of this Agreement by the searching or comparing State shall be permitted solely in order to: (a) establish whether the compared DNA profiles or dactyloscopic data match; (b) prepare and submit a police or judicial request for legal assistance in compliance with domestic law if those data match; (c) record within the meaning of Article 19 of this Chapter. 3. The State administering the file may process the data supplied to it in accordance with Articles 530, 531 and 534 of this Agreement solely where this is necessary for the purposes of comparison, providing automated replies to searches or recording pursuant to Article 19 of this Chapter. The supplied data shall be deleted immediately following data comparison or automated replies to searches unless further processing is necessary for the purposes referred to in points (b) and (c) of paragraph 2 of this Article. 4. Data supplied in accordance with Article 537 of this Agreement may be used by the State administering the file solely where this is necessary for the purpose of providing automated replies to search procedures or recording pursuant to Article 19 of this Chapter. The data supplied shall be deleted immediately following automated replies to searches unless further processing is necessary for recording pursuant to Article 19 of this Chapter. The Member State may use data received in a reply solely for the procedure for which the search was made. Article 17 Accuracy, current relevance and storage time of data 1. The States shall ensure the accuracy and current relevance of personal data. The receiving State shall be notified without delay if it transpires ex officio, or from a notification by the data subject, that incorrect data or data which should not have been supplied have been supplied. The State(s) concerned shall be obliged to correct or delete the data. Moreover, personal data supplied shall be corrected if they are found to be incorrect. If the receiving body has reason to believe that the supplied data are incorrect or should be deleted, the supplying body shall be informed forthwith. 2. Data, the accuracy of which the data subject contests and the accuracy or inaccuracy of which cannot be established shall, in accordance with the domestic law of the States, be marked with a flag at the request of the data subject. If a flag exists, this may be removed subject to the domestic law of the States and only with the permission of the data subject or on the basis of a decision of the competent court or independent data protection authority. 3. Personal data supplied which should not have been supplied or received shall be deleted. Data which are lawfully supplied and received shall be deleted: (a) if they are not or no longer necessary for the purpose for which they were supplied; if personal data have been supplied without request, the receiving body shall immediately check if they are necessary for the purposes for which they were supplied; (b) following the expiry of the maximum period for keeping data laid down in the domestic law of the supplying State, where the supplying body informed the receiving body of that maximum period at the time of supplying the data. 4. Where there is reason to believe that deletion would prejudice the interests of the data subject, the data shall be blocked instead of being deleted in compliance with domestic law. Blocked data may be supplied or used solely for the purpose which prevented their deletion. Article 18 Technical and organisational measures to ensure data protection and data security 1. The supplying and receiving bodies shall take steps to ensure that personal data is effectively protected against accidental or unauthorised destruction, accidental loss, unauthorised access, unauthorised or accidental alteration and unauthorised disclosure. 2. The features of the technical specification of the automated search procedure are regulated in the implementing measures as referred to in Article 539 of this Agreement which guarantee that: (a) state-of-the-art technical measures are taken to ensure data protection and data security, in particular data confidentiality and integrity; (b) encryption and authorisation procedures recognised by the competent authorities are used when having recourse to generally accessible networks; and (c) the admissibility of searches in accordance with paragraphs 2, 5 and 6 of Article 19 of this Chapter can be checked. Article 19 Logging and recording: special rules governing automated and non-automated supply 1. Each State shall guarantee that every non-automated supply and every non-automated receipt of personal data by the body administering the file and by the searching body is logged in order to verify the admissibility of the supply. Logging shall contain the following information: (a) the reason for the supply; (b) the data supplied; (c) the date of the supply; and (d) the name or reference code of the searching body and of the body administering the file. 2. The following shall apply to automated searches for data based on Articles 530, 534 and 537 of this Agreement and to automated comparison pursuant to Article 531 of this Agreement: (a) only specially authorised officers of the national contact points may carry out automated searches or comparisons; the list of officers authorised to carry out automated searches or comparisons shall be made available upon request to the supervisory authorities referred to in paragraph 6 and to the other States; (b) each State shall ensure that each supply and receipt of personal data by the body administering the file and the searching body is recorded, including notification of whether or not a HIT exists; recording shall include the following information: (i) the data supplied; (ii) the date and exact time of the supply; and (iii) the name or reference code of the searching body and of the body administering the file. 3. The searching body shall also record the reason for the search or supply as well as an identifier for the official who carried out the search and the official who ordered the search or supply. 4. The recording body shall immediately communicate the recorded data upon request to the competent data protection authorities of the relevant State at the latest within four weeks following receipt of the request; recorded data may be used solely for the following purposes: (a) monitoring data protection; (b) ensuring data security. 5. The recorded data shall be protected with suitable measures against inappropriate use and other forms of improper use and shall be kept for two years. After the conservation period, the recorded data shall be deleted immediately. 6. Responsibility for legal checks on the supply or receipt of personal data lies with the independent data protection authorities or, as appropriate, the judicial authorities of the respective States. Anyone can request those authorities to check the lawfulness of the processing of data in respect of their person in compliance with domestic law. Independently of such requests, those authorities and the bodies responsible for recording shall carry out random checks on the lawfulness of supply, based on the files involved. 7. The results of such checks shall be kept for inspection for 18 months by the independent data protection authorities. After that period, they shall be immediately deleted. Each data protection authority may be requested by the independent data protection authority of another State to exercise its powers in accordance with domestic law. The independent data protection authorities of the States shall perform the inspection tasks necessary for mutual cooperation, in particular by exchanging relevant information. Article 20 Data subjects' rights to damages Where a body of one State has supplied personal data under Title II of Part Three of this Agreement, the receiving body of the other State cannot use the inaccuracy of the data supplied as grounds to evade its liability vis-à-vis the injured party under domestic law. If damages are awarded against the receiving body because of its use of inaccurate transfer data, the body which supplied the data shall refund the amount paid in damages to the receiving body in full. Article 21 Information requested by the States The receiving State shall inform the supplying State on request of the processing of supplied data and the result obtained. Article 22 Declarations and designations 1. The United Kingdom shall communicate its declarations pursuant to Article 529(3) of this Agreement, and Article 12(1) of this Chapter, as well as its designations pursuant to Articles 535(1) and 537(3) of this Agreement to the Specialised Committee on Law Enforcement and Judicial Cooperation. 2. Factual information provided by the United Kingdom through these declarations and designations, and by Member States in accordance with Article 539(3) of this Agreement, are included in the Manual as referred to in Article 18(2) of Decision 2008/616/JHA. 3. States may amend declarations and designations submitted in accordance with paragraph 1 at any time by means of a notification submitted to the Specialised Committee on Law Enforcement and Judicial Cooperation. The Specialised Committee on Law Enforcement and Judicial Cooperation shall forward any declarations received to the General Secretariat of the Council. 4. The General Secretariat of the Council shall communicate any changes in the Manual referred to in paragraph 2 to the Specialised Committee on Law Enforcement and Judicial Cooperation. Article 23 Preparation of decisions as referred to in Article 540 1. The Council shall take a decision as referred to in Article 540 of this Agreement on the basis of an evaluation report which shall be based on a questionnaire. 2. With respect to the automated data exchange in accordance with Title II of Part Three of this Agreement, the evaluation report shall also be based on an evaluation visit and a pilot run that shall be carried out if required when the United Kingdom has informed the Specialised Committee on Law Enforcement and Judicial Cooperation that they have implemented the obligations imposed on them under Title II of Part Three of this Agreement and submit the declarations provided for in Article 22 of this Chapter. Further details of the procedure are set out in Chapter 4 of this Annex. Article 24 Statistics and reporting 1. An evaluation of the administrative, technical and financial application of the data exchange pursuant to Title II of Part Three of this Agreement shall be carried out on a regular basis. The evaluation shall be carried out with respect to the data categories for which data exchange has started among the States concerned. The evaluation shall be based on reports of the respective States. 2. Each State shall compile statistics on the results of the automated data exchange. In order to ensure comparability, the model for statistics will be compiled by the relevant Council Working Group. These statistics will be forwarded annually to the Specialised Committee on Law Enforcement and Judicial Cooperation. 3. In addition, States will be requested on a regular basis not to exceed once per year to provide further information on the administrative, technical and financial implementation of automated data exchange as needed to analyse and improve the process. 4. Statistics and reporting made by Member States in accordance with Decisions 2008/615/JHA and 2008/616/JHA shall apply in relation to this Article. CHAPTER 1 EXCHANGE OF DNA-DATA 1. DNA related forensic issues, matching rules and algorithms 1.1. Properties of DNA-profiles The DNA profile may contain 24 pairs of numbers representing the alleles of 24 loci which are also used in the DNA-procedures of Interpol. The names of those loci are provided in the following table: VWA TH01 D21S11 FGA D8S1179 D3S1358 D18S51 Amelogenin TPOX CSF1P0 D13S317 D7S820 D5S818 D16S539 D2S1338 D19S433 Penta D Penta E FES F13A1 F13B SE33 CD4 GABA The seven grey loci in the top row are both the present ESS and the ISSOL. Inclusion Rules: The DNA-profiles made available by the States for searching and comparison as well as the DNA-profiles sent out for searching and comparison shall contain at least six full designated (1) loci and may contain additional loci or blanks depending on their availability. The reference DNA profiles shall contain at least six of the seven ESS of loci. In order to raise the accuracy of matches, all available alleles shall be stored in the indexed DNA profile database and be used for searching and comparison. Each State should implement as soon as practically possible any new ESS of loci adopted by the EU. Mixed profiles are not allowed, so that the allele values of each locus will consist of only two numbers, which may be the same in the case of homozygosity at a given locus. Wild-cards and Micro-variants are to be dealt with using the following rules: — Any non-numerical value except amelogenin contained in the profile (e.g. "o", "f", "r", "na", "nr" or "un") has to be automatically converted for the export to a wild card (*) and searched against all, — Numerical values "0", "1" or "99" contained in the profile have to be automatically converted for the export to a wild card (*) and searched against all, — If three alleles are provided for one locus the first allele will be accepted and the remaining two alleles have to be automatically converted for the export to a wild card (*) and searched against all, — When wild card values are provided for allele 1 or 2 then both permutations of the numerical value given for the locus will be searched (e.g. 12, * could match against 12,14 or 9,12), — Pentanucleotide (Penta D, Penta E and CD4) micro-variants will be matched according to the following: — x.1 = x, x.1, x.2 — x.2 = x.1, x.2, x.3 — x.3 = x.2, x.3, x.4 — x.4 = x.3, x.4, x + 1, — Tetranucleotide (the rest of the loci are tetranucleotides) micro-variants will be matched according to the following: — x.1 = x, x.1, x.2 — x.2 = x.1, x.2, x.3 — x.3 = x.2, x.3, x + 1. 1.2. Matching rules The comparison of two DNA-profiles will be performed on the basis of the loci for which a pair of allele values is available in both DNA-profiles. At least six full designated loci (exclusive of amelogenin) must match between both DNA-profiles before a HIT response is provided. A full match (Quality 1) is defined as a match, when all allele values of the compared loci commonly contained in the requesting and requested DNA-profiles are the same. A near match is defined as a match, when the value of only one of all the compared alleles is different in the two DNA profiles (Quality 2, 3 and 4). A near match is only accepted if there are at least six full designated matched loci in the two compared DNA profiles. The reason for a near match may be: — a human typing error at the point of entry of one of the DNA-profiles in the search request or the DNA-database, — an allele-determination or allele-calling error during the generation procedure of the DNA-profile. 1.3. Reporting rules Full matches, near matches and "No-HITs" will all be reported. The matching report will be sent to the requesting national contact point and will also be made available to the requested national contact point (to enable it to estimate the nature and number of possible follow-up requests for further available personal data and other information associated with the DNA-profile corresponding to the HIT in accordance with Article 536 of this Agreement. 2. State code number table In accordance with Title II of Part Three of this Agreement, ISO 3166-1 alpha-2 code are used for setting up the domain names and other configuration parameters required in the Prüm DNA data exchange applications over a closed network. ISO 3166-1 alpha-2 codes are the following two-letter State codes: State names Code State names Code Belgium BE Lithuania LT Bulgaria BG Luxemburg LU Czech Republic CZ Hungary HU Denmark DK Malta MT Germany DE Netherlands NL Estonia EE Austria AT Ireland IE Poland PL Greece EL Portugal PT Spain ES Romania RO France FR Slovakia SK Croatia HR Slovenia SI Italy IT Finland FI Cyprus CY Sweden SE Latvia LV United Kingdom UK 3. Functional analysis 3.1. Availability of the system Requests pursuant to Article 530 of this Agreement should reach the targeted database in the chronological order that each request was sent; responses should be dispatched to reach the requesting State within 15 minutes of the arrival of requests. 3.2. Second step When a State receives a report of a match, its national contact point is responsible for comparing the values of the profile submitted as a question and the values of the profile(s) received as an answer to validate and check the evidential value of the profile. National contact points can contact each other directly for validation purposes. Legal assistance procedures start after validation of an existing match between two profiles, on the basis of a "full match" or a "near match" obtained during the automated consultation phase. 4. DNA interface control document 4.1. Introduction 4.1.1. Objectives This Chapter defines the requirements for the exchange of DNA profile information between the DNA database systems of all States. The header fields are defined specifically for the Prüm DNA exchange; the data part is based on the DNA profile data part in the XML schema defined for the Interpol DNA exchange gateway. Data are exchanged by Simple Mail Transfer Protocol (SMTP) and other state-of-the-art technologies, using a central relay mail server provided by the network provider. The XML file is transported as mail body. 4.1.2. Scope This ICD defines the content of the message (or "mail") only. All network-specific and mail-specific topics are defined uniformly in order to allow a common technical base for the DNA data exchange. This includes: — the format of the subject field in the message to enable/allow for an automated processing of the messages, — whether content encryption is necessary and if yes which methods should be chosen, — the maximum length of messages. 4.1.3. XML structure and principles The XML message is structured into: — the header part, which contains information about the transmission, and — the data part, which contains profile specific information, as well as the profile itself. The same XML schema shall be used for request and response. For the purpose of complete checks of unidentified DNA profiles, as provided for in Article 531 of this Agreement, it shall be possible to send a batch of profiles in one message. A maximum number of profiles within one message must be defined. The number depends on the maximum allowed mail size and shall be defined after selection of the mail server. XML example: <?version="1.0" standalone="yes"?> <PRUEMDNAx xmlns:msxsl="urn:schemas-microsoft-com:xslt" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"> <header> (…) </header> <datas> (…) </datas> [<datas> datas structure repeated, if multiple profiles sent by (…) a single SMTP message, only allowed for Article 531 of this Agreement cases </datas>] </PRUEMDNA> 4.2. XML structure definition The following definitions are for documentation purposes and better readability; the real binding information is provided by an XML schema file (PRUEM DNA.xsd). 4.2.1. Schema PRUEMDNAx It contains the following fields: Fields Type Description header PRUEM_header Occurs: 1 datas PRUEM_datas Occurs: 1 … 500 4.2.2. Content of header structure 4.2.2.1. PRUEM header This is a structure describing the XML file header. It contains the following fields: Fields Type Description direction PRUEM_header_dir Direction of message flow ref String Reference of the XML file generator String Generator of XML file schema_version String Version number of schema to use requesting PRUEM_header_info Requesting State info requested PRUEM_header_info Requested State info 4.2.2.2. PRUEM_header dir Type of data contained in message, value can be: Value Description R Request A Answer 4.2.2.3. PRUEM header info Structure to describe State as well as message date/time. It contains the following fields: Fields Type Description source_isocode String ISO 3166-2 code of the requesting State destination_isocode String ISO 3166-2 code of the requested State request_id String unique Identifier for a request date Date Date of creation of message time Time Time of creation of message 4.2.3. Content of PRUEM Profile data 4.2.3.1. PRUEM_datas This is a structure describing the XML profile data part. It contains the following fields: Fields Type Description reqtype PRUEM request type Type of request (Article 530 or 531) date Date Date profile stored type PRUEM_datas_type Type of profile result PRUEM_datas_result Result of request agency String Name of corresponding unit responsible for the profile profile_ident String Unique State profile ID message String Error Message, if result = E profile IPSG_DNA_profile If direction = A (Answer) AND result ≠ H (HIT) empty match_id String In case of a HIT PROFILE_ID of the requesting profile quality PRUEM_hitquality_type Quality of HIT hitcount Integer Count of matched Alleles rescount Integer Count of matched profiles. If direction = R (Request), then empty. If quality!=0 (the original requested profile), then empty. 4.2.3.2. PRUEM_request_type Type of data contained in message, value can be: Value Description 3 Requests pursuant to Article 530 4 Requests pursuant to Article 531 4.2.3.3. PRUEM_hitquality_type Value Description 0 Referring original requesting profile: Case "No-HIT": original requesting profile sent back only; Case "HIT": original requesting profile and matched profiles sent back. 1 Equal in all available alleles without wildcards 2 Equal in all available alleles with wildcards 3 HIT with Deviation (Microvariant) 4 HIT with mismatch 4.2.3.4. PRUEM_data_type Type of data contained in message, value can be: Value Description P Person profile S Stain 4.2.3.5. PRUEM_data_result Type of data contained in message, value can be: Value Description U Undefined, If direction = R (request) H HIT N No-HIT E Error 4.2.3.6. IPSG_DNA_profile Structure describing a DNA profile. It contains the following fields: Fields Type Description ess_issol IPSG_DNA_ISSOL Group of loci corresponding to the ISSOL (standard group of Loci of Interpol) additional_loci IPSG_DNA_additional_loci Other loci marker String Method used to generate of DNA profile_id String Unique identifier for DNA profile 4.2.3.7. IPSG_DNA_ISSOL Structure containing the loci of ISSOL (Standard Group of Interpol loci). It contains the following fields: Fields Type Description vwa IPSG_DNA_locus Locus vwa th01 IPSG_DNA_locus Locus th01 d21s11 IPSG_DNA_locus Locus d21s11 fga IPSG_DNA_locus Locus fga d8s1179 IPSG_DNA_locus Locus d8s1179 d3s1358 IPSG_DNA_locus Locus d3s1358 d18s51 IPSG_DNA_locus Locus d18s51 amelogenin IPSG_DNA_locus Locus amelogin 4.2.3.8. IPSG_DNA_additional_loci Structure containing the other loci. It contains the following fields: Fields Type Description tpox IPSG_DNA_locus Locus tpox csf1po IPSG_DNA_locus Locus csf1po d13s317 IPSG_DNA_locus Locus d13s317 d7s820 IPSG_DNA_locus Locus d7s820 d5s818 IPSG_DNA_locus Locus d5s818 d16s539 IPSG_DNA_locus Locus d16s539 d2s1338 IPSG_DNA_locus Locus d2s1338 d19s433 IPSG_DNA_locus Locus d19s433 penta_d IPSG_DNA_locus Locus penta_d penta_e IPSG_DNA_locus Locus penta_e fes IPSG_DNA_locus Locus fes f13a1 IPSG_DNA_locus Locus f13a1 f13b IPSG_DNA_locus Locus f13b se33 IPSG_DNA_locus Locus se33 cd4 IPSG_DNA_locus Locus cd4 gaba IPSG_DNA_locus Locus gaba 4.2.3.9. IPSG_DNA_locus Structure describing a locus. It contains the following fields: Fields Type Description low_allele String Lowest value of an allele high_allele String Highest value of an allele 5. Application, security and communication architecture 5.1. Overview In implementing applications for the DNA data exchange within the framework of Title II of Part Three of this Agreement, a common communication network shall be used, which will be logically closed among the States. In order to exploit this common communication infrastructure of sending requests and receiving replies in a more effective way, an asynchronous mechanism to convey DNA and dactyloscopic data requests in a wrapped SMTP e-mail message is adopted. In fulfilment of security concerns, the mechanism s/MIME as extension to the SMTP functionality will be used to establish a true end-to-end secure tunnel over the network. The operational Trans European Services for Telematics between Administrations (TESTA) is used as the communication network for data exchange among the States. TESTA is under the responsibility of the European Commission. Taking into account that national DNA databases and the current national access points of TESTA may be located on different sites in the States, access to TESTA may be set up either by: 1. using the existing national access point or establishing a new national TESTA access point; or 2. setting up a secure local link from the site where the DNA database is located and managed by the competent national agency to the existing national TESTA access point. The protocols and standards deployed in the implementation of Title II of Part Three of this Agreement applications comply with the open standards and meet the requirements imposed by national security policy makers of the States. 5.2. Upper Level Architecture In the scope of Title II of Part Three of this Agreement, each State will make its DNA data available to be exchanged with and/or searched by other States in conformity with the standardised common data format. The architecture is based upon an any-to-any communication model. There exists neither a central computer server nor a centralised database to hold DNA profiles. In addition to the fulfilment of domestic legal constraints at States' sites, each State may decide what kind of hardware and software should be deployed for the configuration at its site to comply with the requirements set out in Title II of Part Three of this Agreement. 5.3. Security Standards and Data Protection Three levels of security concerns have been considered and implemented. 5.3.1. Data Level DNA profile data provided by each State shall have to be prepared in compliance with a common data protection standard, so that requesting States will receive an answer mainly to indicate HIT or No-HIT along with an identification number in case of a HIT, which does not contain any personal information. The further investigation after the notification of a HIT will be conducted at bilateral level pursuant to the existing domestic legal and organisational regulations of the respective States' sites. 5.3.2. Communication Level Messages containing DNA profile information (requesting and replying) will be encrypted by means of a state-of-the-art mechanism in conformity with open standards, such as s/MIME, before they are forwarded to the sites of other States. 5.3.3. Transmission Level All encrypted messages containing DNA profile information will be forwarded onto other States' sites through a virtual private tunnelling system administered by a trusted network provider at the international level and the secure links to this tunnelling system under national responsibility. This virtual private tunnelling system does not have a connection point with the open Internet. 5.4. Protocols and Standards to be used for encryption mechanism: s/MIME and related packages The open standard s/MIME as extension to de facto e-mail standard SMTP will be deployed to encrypt messages containing DNA profile information. The protocol s/MIME (V3) allows signed receipts, security labels, and secure mailing lists and is layered on Cryptographic Message Syntax (CMS), an Internet Engineering Task Force (IETF) specification for cryptographic protected messages. It can be used to digitally sign, digest, authenticate or encrypt any form of digital data. The underlying certificate used by the s/MIME mechanism has to be in compliance with X.509 standard. In order to ensure common standards and procedures with other Prüm applications, the processing rules for s/MIME encryption operations or to be applied under various Commercial Product of the Shelves (COTS) environments, are as follows: — the sequence of the operations is: first encryption and then signing, — the encryption algorithm AES (Advanced Encryption Standard) with 256 bit key length and RSA with 1024 bit key length shall be applied for symmetric and asymmetric encryption respectively, — the hash algorithm SHA-1 shall be applied. s/MIME functionality is built into the vast majority of modern e-mail software packages including Outlook, Mozilla Mail as well as Netscape Communicator 4.x and inter-operates among all major e-mail software packages. Because of s/MIME's easy integration into national IT infrastructure at all States' sites, it is selected as a viable mechanism to implement the communication security level. For achieving the goal "Proof of Concept" in a more efficient way and reducing costs the open standard JavaMail API is however chosen for prototyping DNA data exchange. JavaMail API provides simple encryption and decryption of e-mails using s/MIME and/or OpenPGP. The intent is to provide a single, easy-to-use API for e-mail clients that want to send and receive encrypted e-mail in either of the two most popular e-mail encryption formats. Therefore any state-of-the-art implementations to JavaMail API will suffice for the requirements set by Title II of Part Three of this Agreement, such as the product of Bouncy Castle JCE (Java Cryptographic Extension), which will be used to implement s/MIME for prototyping DNA data exchange among all States. 5.5. Application Architecture Each State will provide the other States with a set of standardised DNA profile data which are in conformity with the current common ICD. This can be done either by providing a logical view over individual national database or by establishing a physical exported database (indexed database). The four main components: E-mail server/s/MIME, Application Server, Data Structure Area for fetching/feeding data and registering incoming/outgoing messages, and Match Engine implement the whole application logic in a product-independent way. In order to provide all States with an easy integration of the components into their respective national sites, the specified common functionality has been implemented by means of open source components, which could be selected by each State depending on its national IT policy and regulations. Because of the independent features to be implemented to get access to indexed databases containing DNA profiles covered by Title II of Part Three of this Agreement, each State can freely select its hardware and software platform, including database and operating systems. A prototype for the DNA Data Exchange has been developed and successfully tested over the existing common network. The version 1.0 has been deployed in the productive environment and is used for daily operations. States may use the jointly developed product but may also develop their own products. The common product components will be maintained, customised and further developed according to changing IT, forensic and/or functional police requirements. 5.6. Protocols and Standards to be used for application architecture: 5.6.1. XML The DNA data exchange will fully exploit XML-schema as attachment to SMTP e-mail messages. The eXtensible Markup Language (XML) is a W3C-recommended general-purpose markup language for creating special-purpose markup languages, capable of describing many different kinds of data. The description of the DNA profile suitable for exchange among all States has been done by means of XML and XML schema in the ICD document. 5.6.2. ODBC Open DataBase Connectivity provides a standard software API method for accessing database management systems and making it independent of programming languages, database and operating systems. ODBC has, however, certain drawbacks. Administering a large number of client machines can involve a diversity of drivers and DLLs. This complexity can increase system administration overhead. 5.6.3. JDBC Java DataBase Connectivity (JDBC) is an API for the Java programming language that defines how a client may access a database. In contrast to ODBC, JDBC does not require to use a certain set of local DLLs at the Desktop. The business logic of processing DNA profile requests and replies at each States' site is described in the following diagram. Both requesting and replying flows interact with a neutral data area comprising different data pools with a common data structure. 5.7. Communication Environment 5.7.1. Common Communication Network: TESTA and its follow-up infrastructure The application DNA data exchange will exploit the e-mail, an asynchronous mechanism, to send requests and to receive replies among the States. As all States have at least one national access point to the TESTA network, the DNA data exchange will be deployed over the TESTA network. TESTA provides a number of added-value services through its e-mail relay. In addition to hosting TESTA specific e-mail boxes, the infrastructure can implement mail distribution lists and routing policies. This allows TESTA to be used as a clearing house for messages addressed to administrations connected to the EU wide Domains. Virus check mechanisms may also be put in place. The TESTA e-mail relay is built on a high availability hardware platform located at the central TESTA application facilities and protected by firewall. The TESTA Domain Name Systems (DNS) will resolve resource locators to IP addresses and hide addressing issues from the user and from applications. 5.7.2. Security Concern The concept of a Virtual Private Network (VPN) has been implemented within the framework of TESTA. Tag Switching Technology used to build this VPN will evolve to support Multi-Protocol Label Switching (MPLS) standard developed by the IETF. MPLS is an IETF standard technology that speeds up network traffic flow by avoiding packet analysis by intermediate routers (hops). This is done on the basis of so-called labels that are attached to packet by the edge routers of the backbone, on the basis of information stored in the forwarding information base (FIB). Labels are also used to implement VPNs. MPLS combines the benefits of layer 3 routing with the advantages of layer 2 switching. Because IP addresses are not evaluated during transition through the backbone, MPLS does not impose any IP addressing limitations. Furthermore, e-mail messages over the TESTA will be protected by s/MIME driven encryption mechanism. Without knowing the key and possessing the right certificate, nobody can decrypt messages over the network. 5.7.3. Protocols and Standards to be used over the communication network 5.7.3.1. SMTP SMTP is the de facto standard for e-mail transmission across the Internet. SMTP is a relatively simple, text-based protocol, where one or more recipients of a message are specified and then the message text is transferred. SMTP uses TCP port 25 upon the specification by the IETF. To determine the SMTP server for a given domain name, the MX (Mail eXchange) DNS (Domain Name Systems) record is used. Since this protocol started as purely ASCII text-based it did not deal well with binary files. Standards such as MIME were developed to encode binary files for transfer through SMTP. Today, most SMTP servers support the 8BITMIME and s/MIME extension, permitting binary files to be transmitted almost as easily as plain text. The processing rules for s/MIME operations are described in the section s/MIME (see Section 5.4). SMTP is a "push" protocol that does not allow one to "pull" messages from a remote server on demand. To do this a mail client shall use POP3 or IMAP. Within the framework of implementing DNA data exchange it is decided to use the protocol POP3. 5.7.3.2. POP Local e-mail clients use the Post Office Protocol version 3 (POP3), an application-layer Internet standard protocol, to retrieve e-mail from a remote server over a TCP/IP connection. By using the SMTP Submit profile of the SMTP protocol, e-mail clients send messages across the Internet or over a corporate network. MIME serves as the standard for attachments and non-ASCII text in e-mail. Although neither POP3 nor SMTP requires MIME-formatted e-mail, essentially Internet e-mail comes MIME-formatted, so POP clients must also understand and use MIME. The whole communication environment of Title II of Part Three of this Agreement will therefore include the components of POP. 5.7.4. Network Address Assignment Operative environment A dedicated block half B class subnet has currently been allocated by the European IP registration authority (RIPE) to TESTA. The assignment of IP addresses to States is based upon a geographical schema in Europe. The data exchange among States within the framework of Title II of Part Three of this Agreement is operated over a European wide logically closed IP network. Testing Environment In order to provide a smooth running environment for the daily operation among all connected States, it is necessary to establish a testing environment over the closed network for new States which prepare to join the operations. A sheet of parameters including IP addresses, network settings, e-mail domains as well as application user accounts has been specified and should be set up at the corresponding State's site. Moreover, a set of pseudo DNA profiles has been constructed for test purposes. 5.7.5. Configuration Parameters A secure e-mail system is set up using the eu-admin.net domain. That domain with the associated addresses will not be accessible from a location not on the TESTA EU wide domain, because the names are only known on the TESTA central DNS server, which is shielded from the Internet. The mapping of these TESTA site addresses (host names) to their IP addresses is done by the TESTA DNS service. For each Local Domain, a Mail entry will be added to this TESTA central DNS server, relaying all e-mail messages sent to TESTA Local Domains to the TESTA central Mail Relay. That TESTA central Mail Relay will then forward them to the specific Local Domain e-mail server using the Local Domain e-mail addresses. By relaying the e-mail in this way, critical information contained in e-mails will only pass the Europe-wide closed network infrastructure and not the insecure Internet. It is necessary to establish sub-domains (bold italics) at the sites of all States upon the following syntax: "application-type.State-code.pruem.testa.eu", where: "State-code" takes the value of one of the two letter-code State codes (i.e. AT, BE, etc.); "application-type" takes one of the values: DNA, FP and CAR. By applying the above syntax, the sub domains for the States are shown in the following table: States' sub domains syntax State Sub Domains Comments BE dna.be.pruem.testa.eu fp.be.pruem.testa.eu car.be.pruem.testa.eu test.dna.be.pruem.testa.eu test.fp.be.pruem.testa.eu test.car.be.pruem.testa.eu BG dna.bg.pruem.testa.eu fp.bg.pruem.testa.eu car.bg.pruem.testa.eu test.dna.bg.pruem.testa.eu test.fp.bg.pruem.testa.eu test.car.bg.pruem.testa.eu CZ dna.cz.pruem.testa.eu fp.cz.pruem.testa.eu car.cz.pruem.testa.eu test.dna.cz.pruem.testa.eu test.fp.cz.pruem.testa.eu test.car.cz.pruem.testa.eu DK dna.dk.pruem.testa.eu fp.dk.pruem.testa.eu car.dk.pruem.testa.eu test.dna.dk.pruem.testa.eu test.fp.dk.pruem.testa.eu test.car.dk.pruem.testa.eu DE dna.de.pruem.testa.eu fp.de.pruem.testa.eu car.de.pruem.testa.eu test.dna.de.pruem.testa.eu test.fp.de.pruem.testa.eu test.car.de.pruem.testa.eu EE dna.ee.pruem.testa.eu fp.ee.pruem.testa.eu car.ee.pruem.testa.eu test.dna.ee.pruem.testa.eu test.fp.ee.pruem.testa.eu test.car.ee.pruem.testa.eu IE dna.ie.pruem.testa.eu fp.ie.pruem.testa.eu car.ie.pruem.testa.eu test.dna.ie.pruem.testa.eu test.fp.ie.pruem.testa.eu test.car.ie.pruem.testa.eu EL dna.el.pruem.testa.eu fp.el.pruem.testa.eu car.el.pruem.testa.eu test.dna.el.pruem.testa.eu test.fp.el.pruem.testa.eu test.car.el.pruem.testa.eu ES dna.es.pruem.testa.eu fp.es.pruem.testa.eu car.es.pruem.testa.eu test.dna.es.pruem.testa.eu test.fp.es.pruem.testa.eu test.car.es.pruem.testa.eu FR dna.fr.pruem.testa.eu fp.fr.pruem.testa.eu car.fr.pruem.testa.eu test.dna.fr.pruem.testa.eu test.fp.fr.pruem.testa.eu test.car.fr.pruem.testa.eu HR dna.hr.pruem.testa.eu fp.hr.pruem.testa.eu car.hr.pruem.testa.eu test.dna.hr.pruem.testa.eu test.fp.hr.pruem.testa.eu test.car.hr.pruem.testa.eu IT dna.it.pruem.testa.eu fp.it.pruem.testa.eu car.it.pruem.testa.eu test.dna.it.pruem.testa.eu test.fp.it.pruem.testa.eu test.car.it.pruem.testa.eu CY dna.cy.pruem.testa.eu fp.cy.pruem.testa.eu car.cy.pruem.testa.eu test.dna.cy.pruem.testa.eu test.fp.cy.pruem.testa.eu test.car.cy.pruem.testa.eu LV dna.lv.pruem.testa.eu fp.lv.pruem.testa.eu car.lv.pruem.testa.eu test.dna.lv.pruem.testa.eu test.fp.lv.pruem.testa.eu test.car.lv.pruem.testa.eu LT dna.lt.pruem.testa.eu fp.lt.pruem.testa.eu car.lt.pruem.testa.eu test.dna.lt.pruem.testa.eu test.fp.lt.pruem.testa.eu test.car.lt.pruem.testa.eu LU dna.lu.pruem.testa.eu fp.lu.pruem.testa.eu car.lu.pruem.testa.eu test.dna.lu.pruem.testa.eu test.fp.lu.pruem.testa.eu test.car.lu.pruem.testa.eu HU dna.hu.pruem.testa.eu fp.hu.pruem.testa.eu car.hu.pruem.testa.eu test.dna.hu.pruem.testa.eu test.fp.hu.pruem.testa.eu test.car.hu.pruem.testa.eu MT dna.mt.pruem.testa.eu fp.mt.pruem.testa.eu car.mt.pruem.testa.eu test.dna.mt.pruem.testa.eu test.fp.mt.pruem.testa.eu test.car.mt.pruem.testa.eu NL dna.nl.pruem.nl.testa.eu fp.nl.pruem.testa.eu car.nl.pruem.testa.eu test.dna.nl.pruem.testa.eu test.fp.nl.pruem.testa.eu test.car.nl.pruem.testa.eu AT dna.at.pruem.testa.eu fp.at.pruem.testa.eu car.at.pruem.testa.eu test.dna.at.pruem.testa.eu test.fp.at.pruem.testa.eu test.car.at.pruem.testa.eu PL dna.pl.pruem.testa.eu fp.pl.pruem.testa.eu car.pl.pruem.testa.eu test.dna.pl.pruem.testa.eu test.fp.pl.pruem.testa.eu test.car.pl.pruem.testa.eu PT dna.pt.pruem.testa.eu fp.pt.pruem.testa.eu car.pt.pruem.testa.eu test.dna.pt.pruem.testa.eu test.fp.pt.pruem.testa.eu test.car.pt.pruem.testa.eu RO dna.ro.pruem.testa.eu fp.ro.pruem.testa.eu car.ro.pruem.testa.eu test.dna.ro.pruem.testa.eu test.fp.ro.pruem.testa.eu test.car.ro.pruem.testa.eu SI dna.si.pruem.testa.eu fp.si.pruem.testa.eu car.si.pruem.testa.eu test.dna.si.pruem.testa.eu test.fp.si.pruem.testa.eu test.car.si.pruem.testa.eu SK dna.sk.pruem.testa.eu fp.sk.pruem.testa.eu car.sk.pruem.testa.eu test.dna.sk.pruem.testa.eu test.fp.sk.pruem.testa.eu test.car.sk.pruem.testa.eu FI dna.fi.pruem.testa.eu fp.fi.pruem.testa.eu car.fi.pruem.testa.eu test.dna.fi.pruem.testa.eu test.fp.fi.pruem.testa.eu test.car.fi.pruem.testa.eu SE dna.se.pruem.testa.eu fp.se.pruem.testa.eu car.se.pruem.testa.eu test.dna.se.pruem.testa.eu test.fp.se.pruem.testa.eu test.car.se.pruem.testa.eu UK dna.uk.pruem.testa.eu fp.uk.pruem.testa.eu car.uk.pruem.testa.eu test.dna.uk.pruem.testa.eu test.fp.uk.pruem.testa.eu test.car.uk.pruem.testa.eu CHAPTER 2 EXCHANGE OF DACTYLOSCOPIC DATA (INTERFACE CONTROL DOCUMENT) The purpose of the following document interface Control Document is to define the requirements for the exchange of dactyloscopic information between the Automated Fingerprint Identification Systems (AFIS) of the States. It is based on the Interpol-Implementation of ANSI/NIST-ITL 1-2000 (INT-I, Version 4.22b). This version shall cover all basic definitions for Logical Records Type-1, Type-2, Type-4, Type-9, Type-13 and Type-15 required for image- and minutiæ-based dactyloscopic processing. 1. File Content Overview A dactyloscopic file consists of several logical records. There are sixteen types of record specified in the original ANSI/NIST-ITL 1-2000 standard. Appropriate ASCII separation characters are used between each record and the fields and subfields within the records. Only 6 record types are used to exchange information between the originating and the destination agency: Type-1 → Transaction information Type-2 → Alphanumeric persons/case data Type-4 → High resolution greyscale dactyloscopic images Type-9 → Minutiæ Record Type-13 → Variable resolution latent image record Type-15 → Variable resolution palmprint image record 1.1. Type-1 — File header This record contains routing information and information describing the structure of the rest of the file. This record type also defines the types of transaction which fall under the following broad categories: 1.2. Type-2 — Descriptive text This record contains textual information of interest to the sending and receiving agencies. 1.3. Type-4 — High resolution greyscale image This record is used to exchange high resolution greyscale (eight bit) dactyloscopic images sampled at 500 pixels/inch. The dactyloscopic images shall be compressed using the WSQ algorithm with a ratio of not more than 15:1. Other compression algorithms or uncompressed images shall not be used. 1.4. Type-9 — Minutiæ record Type-9 records are used to exchange ridge characteristics or minutiæ data. Their purpose is partly to avoid unnecessary duplication of AFIS encoding processes and partly to allow the transmission of AFIS codes which contain less data than the corresponding images. 1.5. Type-13 — Variable-Resolution Latent Image Record This record shall be used to exchange variable-resolution latent fingerprint and latent palmprint images together with textural alphanumerical information. The scanning resolution of the images shall be 500 pixels/inch with 256 grey-levels. If the quality of the latent image is sufficient it shall be compressed using WSQ-algorithm. If necessary the resolution of the images may be expanded to more than 500 pixels/inch and more than 256 grey-levels by mutual agreement. In that case, it is strongly recommended to use JPEG 2000 (see Appendix 39-7). 1.6. Variable-Resolution Palmprint Image Record Type-15 tagged field image records shall be used to exchange variable-resolution palmprint images together with textural alphanumerical information. The scanning resolution of the images shall be 500 pixels/inch with 256 grey-levels. To minimise the amount of data, all palmprint images shall be compressed using WSQ-algorithm. If necessary the resolution of the images may be expanded to more than 500 pixels/inch and more than 256 grey-levels by mutual agreement. In that case, it is strongly recommended to use JPEG 2000 (see Appendix 39-7). 2. Record format A transaction file shall consist of one or more logical records. For each logical record contained in the file, several information fields appropriate to that record type shall be present. Each information field may contain one or more basic single-valued information items. Taken together these items are used to convey different aspects of the data contained in that field. An information field may also consist of one or more information items grouped together and repeated multiple times within a field. Such a group of information items is known as a subfield. An information field may therefore consist of one or more subfields of information items. 2.1. Information separators In the tagged-field logical records, mechanisms for delimiting information are implemented by use of four ASCII information separators. The delimited information may be items within a field or subfield, fields within a logical record, or multiple occurrences of subfields. These information separators are defined in the standard ANSI X3.4. These characters are used to separate and qualify information in a logical sense. Viewed in a hierarchical relationship, the File Separator "FS" character is the most inclusive followed by the Group Separator "GS", the Record Separator "RS", and finally the Unit Separator "US" characters. Table 1 lists these ASCII separators and a description of their use within this standard. Information separators should be functionally viewed as an indication of the type data that follows. The "US" character shall separate individual information items within a field or subfield. This is a signal that the next information item is a piece of data for that field or subfield. Multiple subfields within a field separated by the "RS" character signals the start of the next group of repeated information item(s). The "GS" separator character used between information fields signals the beginning of a new field preceding the field identifying number that shall appear. Similarly, the beginning of a new logical record shall be signalled by the appearance of the "FS" character. The four characters are only meaningful when used as separators of data items in the fields of the ASCII text records. There is no specific meaning attached to these characters occurring in binary image records and binary fields — they are just part of the exchanged data. Normally, there should be no empty fields or information items and therefore only one separator character should appear between any two data items. The exception to this rule occurs for those instances where the data in fields or information items in a transaction are unavailable, missing, or optional, and the processing of the transaction is not dependent upon the presence of that particular data. In those instances, multiple and adjacent separator characters shall appear together rather than requiring the insertion of dummy data between separator characters. For the definition of a field that consists of three information items, the following applies. If the information for the second information item is missing, then two adjacent "US" information separator characters would occur between the first and third information items. If the second and third information items were both missing, then three separator characters should be used — two "US" characters in addition to the terminating field or subfield separator character. In general, if one or more mandatory or optional information items are unavailable for a field or subfield, then the appropriate number of separator character should be inserted. It is possible to have side-by-side combinations of two or more of the four available separator characters. When data are missing or unavailable for information items, subfields, or fields, there shall be one separator character less than the number of data items, subfields, or fields required. Table 1 Separators Used Code Type Description Hexadecimal Value Decimal Value US Unit Separator Separates information items 1F 31 RS Record Separator Separates subfields 1E 30 GS Group Separator Separates fields 1D 29 FS File Separator Separates logical records 1C 28 2.2. Record layout For tagged-field logical records, each information field that is used shall be numbered in accordance with this standard. The format for each field shall consist of the logical record type number followed by a period ".", a field number followed by a colon ":", followed by the information appropriate to that field. The tagged-field number can be any one-to-nine digit number occurring between the period "." and the colon ":". It shall be interpreted as an unsigned integer field number. This implies that a field number of "2.123:" is equivalent to and shall be interpreted in the same manner as a field number of "2.000000123:". For purposes of illustration throughout this document, a three-digit number shall be used for enumerating the fields contained in each of the tagged-field logical records described herein. Field numbers will have the form of "TT.xxx:" where the "TT" represents the one- or two-character record type followed by a period. The next three characters comprise the appropriate field number followed by a colon. Descriptive ASCII information or the image data follows the colon. Logical Type-1 and Type-2 records contain only ASCII textual data fields. The entire length of the record (including field numbers, colons, and separator characters) shall be recorded as the first ASCII field within each of these record types. The ASCII File Separator "FS" control character (signifying the end of the logical record or transaction) shall follow the last byte of ASCII information and shall be included in the length of the record. In contrast to the tagged-field concept, the Type-4 record contains only binary data recorded as ordered fixed-length binary fields. The entire length of the record shall be recorded in the first four-byte binary field of each record. For this binary record, neither the record number with its period, nor the field identifier number and its following colon, shall be recorded. Furthermore, as all the field lengths of this record is either fixed or specified, none of the four separator characters ("US", "RS", "GS", or "FS") shall be interpreted as anything other than binary data. For the binary record, the "FS" character shall not be used as a record separator or transaction terminating character. 3. Type-1 Logical Record: the File Header This record describes the structure of the file, the type of the file, and other important information. The character set used for Type-1 fields shall contain only the 7-bit ANSI code for information interchange. 3.1. Fields for Type-1 Logical Record 3.1.1. Field 1.001: Logical Record Length (LEN) This field contains the total count of the number of bytes in the whole Type-1 logical record. The field begins with "1.001:", followed by the total length of the record including every character of every field and the information separators. 3.1.2. Field 1.002: Version Number (VER) To ensure that users know which version of the ANSI/NIST standard is being used, this four byte field specifies the version number of the standard being implemented by the software or system creating the file. The first two bytes specify the major version reference number, the second two the minor revision number. For example, the original 1986 Standard would be considered the first version and designated "0100" while the present ANSI/NIST-ITL 1-2000 standard is "0300". 3.1.3. Field 1.003: File Content (CNT) This field lists each of the records in the file by record type and the order in which the records appear in the logical file. It consists of one or more subfields, each of which in turn contains two information items describing a single logical record found in the current file. The subfields are entered in the same order in which the records are recorded and transmitted. The first information item in the first subfield is "1", to refer to this Type-1 record. It is followed by a second information item which contains the number of other records contained in the file. This number is also equal to the count of the remaining subfields of field 1.003. Each of the remaining subfields is associated with one record within the file, and the sequence of subfields corresponds to the sequence of records. Each subfield contains two items of information. The first is to identify the Type of the record. The second is the record's IDC. The "US" character shall be used to separate the two information items. 3.1.4. Field 1.004: Type of Transaction (TOT) This field contains a three letter mnemonic designating the type of the transaction. These codes may be different from those used by other implementations of the ANSI/NIST standard. CPS: Criminal Print-to-Print Search. This transaction is a request for a search of a record relating to a criminal offence against a prints database. The person's prints shall be included as WSQ-compressed images in the file. In case of a No-HIT, the following logical records will be returned: — 1 Type-1 Record, — 1 Type-2 Record. In case of a HIT, the following logical records will be returned: — 1 Type-1 Record, — 1 Type-2 Record, — 1-14 Type-4 Record. The CPS TOT is summarised in Table A.6.1 (Appendix 39-6). PMS: Print-to-Latent Search. This transaction is used when a set of prints is searched against an Unidentified Latent database. The response will contain the HIT/No-HIT decision of the destination AFIS search. If multiple unidentified latents exist, multiple SRE transactions will be returned, with one latent per transaction. The person's prints shall be included as WSQ-compressed images in the file. In case of a No-HIT, the following logical records will be returned: — 1 Type-1 Record, — 1 Type-2 Record. In case of a HIT, the following logical records will be returned: — 1 Type-1 Record, — 1 Type-2 Record, — 1 Type-13 Record. The PMS TOT is summarised in Table A.6.1 (Appendix 39-6). MPS: Latent-to-Print Search. This transaction is used when a latent is to be searched against a Prints database. The latent minutiæ information and the image (WSQ-compressed) shall be included in the file. In case of a No-HIT, the following logical records will be returned: — 1 Type-1 Record, — 1 Type-2 Record. In case of a HIT, the following logical records will be returned: — 1 Type-1 Record, — 1 Type-2 Record, — 1 Type-4 or Type-15 Record. The MPS TOT is summarised in Table A.6.4 (Appendix 39-6). MMS: Latent-to-Latent Search. In this transaction the file contains a latent which is to be searched against an Unidentified Latent database in order to establish links between various scenes of crime. The latent minutiæ information and the image (WSQ-compressed) must be included in the file. In case of a No-HIT, the following logical records will be returned: — 1 Type-1 Record, — 1 Type-2 Record. In case of a HIT, the following logical records will be returned: — 1 Type-1 Record, — 1 Type-2 Record, — 1 Type-13 Record. The MMS TOT is summarised in Table A.6.4 (Appendix 39-6). SRE: This transaction is returned by the destination agency in response to dactyloscopic submissions. The response will contain the HIT/No-HIT decision of the destination AFIS search. If multiple candidates exist, multiple SRE transactions will be returned, with one candidate per transaction. The SRE TOT is summarised in Table A.6.2 (Appendix 39-6). ERR: This transaction is returned by the destination AFIS to indicate a transaction error. It includes a message field (ERM) indicating the error detected. The following logical records will be returned: — 1 Type-1 Record, — 1 Type-2 Record. The ERR TOT is summarised in Table A.6.3 (Appendix 39-6). Table 2 Permissible Codes in Transactions Transaction Type Logical Record Type 1 2 4 9 13 15 CPS M M M — — — SRE M M C — (C in case of latent HITs) C C MPS M M — M (1*) M — MMS M M — M (1*) M — PMS M M M* — — M* ERR M M — — — — Key: M = Mandatory, M* = Only one of both record-types may be included, O = Optional, C = Conditional on whether data is available, — = Not allowed, 1* = Conditional depending on legacy systems. 3.1.5. Field 1.005: Date of Transaction (DAT) This field indicates the date on which the transaction was initiated and shall conform to the ISO standard notation of: YYYYMMDD where YYYY is the year, MM is the month and DD is the day of the month. Leading zeros are used for single figure numbers. For example, "19931004" represents 4 October 1993. 3.1.6. Field 1.006: Priority (PRY) This optional field defines the priority, on a level of 1 to 9, of the request. "1" is the highest priority and "9" the lowest. Priority "1" transactions shall be processed immediately. 3.1.7. Field 1.007: Destination Agency Identifier (DAI) This field specifies the destination agency for the transaction. It consists of two information items in the following format: CC/agency. The first information item contains the Country Code, defined in ISO 3166, two alpha-numeric characters long. The second item, agency, is a free text identification of the agency, up to a maximum of 32 alpha-numeric characters. 3.1.8. Field 1.008: Originating Agency Identifier (ORI) This field specifies the file originator and has the same format as the DAI (Field 1.007). 3.1.9. Field 1.009: Transaction Control Number (TCN) This is a control number for reference purposes. It should be generated by the computer and have the following format: YYSSSSSSSSA where YY is the year of the transaction, SSSSSSSS is an eight-digit serial number, and A is a check character generated by following the procedure given in Appendix 39-2. Where a TCN is not available, the field, YYSSSSSSSS, is filled with zeros and the check character generated as above. 3.1.10. Field 1.010: Transaction Control Response (TCR) Where a request was sent out, to which this is the response, this optional field will contain the transaction control number of the request message. It therefore has the same format as TCN (Field 1.009). 3.1.11. Field 1.011: Native Scanning Resolution (NSR) This field specifies the normal scanning resolution of the system supported by the originator of the transaction. The resolution is specified as two numeric digits followed by the decimal point and then two more digits. For all transactions pursuant to Articles 533 and 534 of this Agreement the sampling rate shall be 500 pixels/inch or 19,68 pixels/mm. 3.1.12. Field 1.012: Nominal Transmitting Resolution (NTR) This five-byte field specifies the nominal transmitting resolution for the images being transmitted. The resolution is expressed in pixels/mm in the same format as NSR (Field 1.011). 3.1.13. Field 1.013: Domain name (DOM) This mandatory field identifies the domain name for the user-defined Type-2 logical record implementation. It consists of two information items and shall be "INT-I{}{US}}4.22{}{GS}}". 3.1.14. Field 1.014: Greenwich mean time (GMT) This mandatory field provides a mechanism for expressing the date and time in terms of universal Greenwich Mean Time (GMT) units. If used, the GMT field contains the universal date that will be in addition to the local date contained in Field 1.005 (DAT). Use of the GMT field eliminates local time inconsistencies encountered when a transaction and its response are transmitted between two places separated by several time zones. The GMT provides a universal date and 24-hour clock time independent of time zones. It is represented as "CCYYMMDDHHMMSSZ", a 15-character string that is the concatenation of the date with the GMT and concludes with a "Z". The "CCYY" characters shall represent the year of the transaction, the "MM" characters shall be the tens and units values of the month, and the "DD" characters shall be the tens and units values of the day of the month, the "HH" characters represent the hour, the "MM" the minute, and the "SS" represents the second. The complete date shall not exceed the current date. 4. Type-2 Logical Record: Descriptive Text The structure of most of this record is not defined by the original ANSI/NIST standard. The record contains information of specific interest to the agencies sending or receiving the file. To ensure that communicating dactyloscopic systems are compatible, it is required that only the fields listed below are contained within the record. This document specifies which fields are mandatory and which optional, and also defines the structure of the individual fields. 4.1. Fields for Type-2 Logical Record 4.1.1. Field 2.001: Logical Record Length (LEN) This mandatory field contains the length of this Type-2 record, and specifies the total number of bytes including every character of every field contained in the record and the information separators. 4.1.2. Field 2.002: Image Designation Character (IDC) The IDC contained in this mandatory field is an ASCII representation of the IDC as defined in the File Content field (CNT) of the Type-1 record (Field 1.003). 4.1.3. Field 2.003: System Information (SYS) This field is mandatory and contains four bytes which indicate which version of the INT-I this particular Type-2 record complies with. The first two bytes specify the major version number, the second two the minor revision number. For example, this implementation is based on INT-I version 4 revision 22 and would be represented as "0422". 4.1.4. Field 2.007: Case Number (CNO) This is a number assigned by the local dactyloscopic bureau to a collection of latents found at a scene-of-crime. The following format is adopted: CC/number where CC is the Interpol Country Code, two alpha-numeric characters in length, and the number complies with the appropriate local guidelines and may be up to 32 alpha-numeric characters long. This field allows the system to identify latents associated with a particular crime. 4.1.5. Field 2.008: Sequence Number (SQN) This specifies each sequence of latents within a case. It can be up to four numeric characters long. A sequence is a latent or series of latents which are grouped together for the purposes of filing and/or searching. This definition implies that even single latents will still have to be assigned a sequence number. This field together with MID (Field 2.009) may be included to identify a particular latent within a sequence. 4.1.6. Field 2.009: Latent Identifier (MID) This specifies the individual latent within a sequence. The value is a single letter or two letters, with "A" assigned to the first latent, "B" to the second, and so on up to a limit of "ZZ". This field is used analogue to the latent sequence number discussed in the description for SQN (Field 2.008). 4.1.7. Field 2.010: Criminal Reference Number (CRN) This is a unique reference number assigned by a national agency to an individual who is charged for the first time with committing an offence. Within one country no individual ever has more than one CRN, or shares it with any other individual. However, the same individual may have Criminal Reference Numbers in several countries, which will be distinguishable by means of the country code. The following format is adopted for CRN field: CC/number where CC is the Country Code, defined in ISO 3166, two alpha-numeric characters in length, and the number complies with the appropriate national guidelines of the issuing agency, and may be up to 32 alpha-numeric characters long. For transactions pursuant to Articles 533 and 534 of this Agreement this field will be used for the national criminal reference number of the originating agency which is linked to the images in Type-4 or Type-15 Records. 4.1.8. Field 2.012: Miscellaneous Identification Number (MN1) This fields contains the CRN (Field 2.010) transmitted by a CPS or PMS transaction without the leading country code. 4.1.9. Field 2.013: Miscellaneous Identification Number (MN2) This fields contains the CNO (Field 2.007) transmitted by an MPS or MMS transaction without the leading country code. 4.1.10. Field 2.014: Miscellaneous Identification Number (MN3) This fields contains the SQN (Field 2.008) transmitted by an MPS or MMS transaction. 4.1.11. Field 2.015: Miscellaneous Identification Number (MN4) This fields contains the MID (Field 2.009) transmitted by an MPS or MMS transaction. 4.1.12. Field 2.063: Additional Information (INF) In case of an SRE transaction to a PMS request this field gives information about the finger which caused the possible HIT. The format of the field is: NN where NN is the finger position code defined in Table 5, two digits in length. In all other cases the field is optional. It consists of up to 32 alpha-numeric characters and may give additional information about the request. 4.1.13. Field 2.064: Respondents List (RLS) This field contains at least two subfields. The first subfield describes the type of search that has been carried out, using the three-letter mnemonics which specify the transaction type in TOT (Field 1.004). The second subfield contains a single character. An "I" shall be used to indicate that a HIT has been found and an "N" shall be used to indicate that no matching cases have been found (No-HIT). The third subfield contains the sequence identifier for the candidate result and the total number of candidates separated by a slash. Multiple messages will be returned if multiple candidates exist. In case of a possible HIT the fourth subfield shall contain the score up to six digits long. If the HIT has been verified the value of this subfield is defined as "999999". Example: "CPS{}{RS}}I{}{RS}}001/001{}{RS}}999999{}{GS}}" If the remote AFIS does not assign scores, then a score of zero should be used at the appropriate point. 4.1.14. Field 2.074: Status/Error Message Field (ERM) This field contains error messages resulting from transactions, which will be sent back to the requester as part of an Error Transaction. Table 3 Error messages Numeric code (1-3) Meaning (5-128) 003 ERROR: UNAUTHORISED ACCESS 101 Mandatory field missing 102 Invalid record type 103 Undefined field 104 Exceed the maximum occurrence 105 Invalid number of subfields 106 Field length too short 107 Field length too long 108 Field is not a number as expected 109 Field number value too small 110 Field number value too big 111 Invalid character 112 Invalid date 115 Invalid item value 116 Invalid type of transaction 117 Invalid record data 201 ERROR: INVALID TCN 501 ERROR: INSUFFICIENT FINGERPRINT QUALITY 502 ERROR: MISSING FINGERPRINTS 503 ERROR: FINGERPRINT SEQUENCE CHECK FAILED 999 ERROR: ANY OTHER ERROR. FOR FURTHER DETAILS CALL DESTINATION AGENCY. Error messages in the range between 100 and 199: These error messages are related to the validation of the ANSI/NIST records and defined as: <error_code 1>: IDC <idc_number 1> FIELD <field_id 1> <dynamic text 1> LF <error_code 2>: IDC <idc_number 2> FIELD <field_id 2> <dynamic text 2>… where — error_code is a code uniquely related to a specific reason (see Table 3), — field_id is the ANSI/NIST field number of the incorrect field (e.g. 1.001, 2.001, …) in the format <record_type>.<field_id>.<sub_field_id>, — dynamic text is a more detailed dynamic description of the error, — LF is a Line Feed separating errors if more than one error is encountered, — for type-1 record the ICD is defined as "-1". Example: 201: IDC - 1 FIELD 1.009 WRONG CONTROL CHARACTER {}{LF}} 115: IDC 0 FIELD 2.003 INVALID SYSTEM INFORMATION This field is mandatory for error transactions. 4.1.15. Field 2.320: Expected Number of Candidates (ENC) This field contains the maximum number of candidates for verification expected by the requesting agency. The value of ENC shall not exceed the values defined in Table 11. 5. Type-4 Logical Record: High Resolution GreyScale Image It should be noted that Type-4 records are binary rather than ASCII in nature. Therefore each field is assigned a specific position within the record, which implies that all fields are mandatory. The standard allows both image size and resolution to be specified within the record. It requires Type-4 Logical Records to contain dactyloscopic image data that are being transmitted at a nominal pixel density of 500 to 520 pixels per inch. The preferred rate for new designs is at a pixel density of 500 pixels per inch or 19,68 pixels per mm. 500 pixels per inch is the density specified by the INT-I, except that similar systems may communicate with each other at a non-preferred rate, within the limits of 500 to 520 pixels per inch. 5.1. Fields for Type-4 Logical Record 5.1.1. Field 4.001: Logical Record Length (LEN) This four-byte field contains the length of this Type-4 record, and specifies the total number of bytes including every byte of every field contained in the record. 5.1.2. Field 4.002: Image Designation Character (IDC) This is the one-byte binary representation of the IDC number given in the header file. 5.1.3. Field 4.003: Impression Type (IMP) The impression type is a single-byte field occupying the sixth byte of the record. Table 4 Finger Impression Type Code Description 0 Live-scan of plain fingerprint 1 Live-scan of rolled fingerprint 2 Non-live scan impression of plain fingerprint captured from paper 3 Non-live scan impression of rolled fingerprint captured from paper 4 Latent impression captured directly 5 Latent tracing 6 Latent photo 7 Latent lift 8 Swipe 9 Unknown 5.1.4. Field 4.004: Finger Position (FGP) This fixed-length field of six bytes occupies the seventh through twelfth byte positions of a Type-4 record. It contains possible finger positions beginning in the left most byte (byte seven of the record). The known or most probable finger position is taken from Table 5. Up to five additional fingers may be referenced by entering the alternate finger positions in the remaining five bytes using the same format. If fewer than five finger position references are to be used the unused bytes are filled with binary 255. To reference all finger positions code 0, for unknown, is used. Table 5 Finger position code and maximum size Finger position Finger code Width (mm) Length (mm) Unknown 0 40,0 40,0 Right thumb 1 45,0 40,0 Right index finger 2 40,0 40,0 Right middle finger 3 40,0 40,0 Right ring finger 4 40,0 40,0 Right little finger 5 33,0 40,0 Left thumb 6 45,0 40,0 Left index finger 7 40,0 40,0 Left middle finger 8 40,0 40,0 Left ring finger 9 40,0 40,0 Left little finger 10 33,0 40,0 Plain right thumb 11 30,0 55,0 Plain left thumb 12 30,0 55,0 Plain right four fingers 13 70,0 65,0 Plain left four fingers 14 70,0 65,0 For scene of crime latents only the codes 0 to 10 should be used. 5.1.5. Field 4.005: Image Scanning Resolution (ISR) This one-byte field occupies the 13th byte of a Type-4 record. If it contains "0" then the image has been sampled at the preferred scanning rate of 19,68 pixels/mm (500 pixels per inch). If it contains "1" then the image has been sampled at an alternative scanning rate as specified in the Type-1 record. 5.1.6. Field 4.006: Horizontal Line Length (HLL) This field is positioned at bytes 14 and 15 within the Type-4 record. It specifies the number of pixels contained in each scan line. The first byte will be the most significant. 5.1.7. Field 4.007: Vertical Line Length (VLL) This field records in bytes 16 and 17 the number of scan lines present in the image. The first byte is the most significant. 5.1.8. Field 4.008: Greyscale Compression Algorithm (GCA) This one-byte field specifies the greyscale compression algorithm used to encode the image data. For this implementation, a binary code 1 indicates that WSQ compression (Appendix 39-7) has been used. 5.1.9. Field 4.009: The Image This field contains a byte stream representing the image. Its structure will obviously depend on the compression algorithm used. 6. Type-9 Logical Record: Minutiæ Record Type-9 records shall contain ASCII text describing minutiæ and related information encoded from a latent. For latent search transaction, there is no limit for these Type-9 records in a file, each of which shall be for a different view or latent. 6.1. Minutiæ extraction 6.1.1. Minutia type identification This standard defines three identifier numbers that are used to describe the minutia type. These are listed in Table 6. A ridge ending shall be designated Type 1. A bifurcation shall be designated Type 2. If a minutia cannot be clearly categorised as one of the above two types, it shall be designated as "other", Type 0. Table 6 Minutia types Type Description 0 Other 1 Ridge ending 2 Bifurcation 6.1.2. Minutia placement and type For templates to be compliant with Section 5 of the ANSI INCITS 378-2004 standard, the following method, which enhances the current INCITS 378-2004 standard, shall be used for determining placement (location and angular direction) of individual minutiæ. The position or location of a minutia representing a ridge ending shall be the point of forking of the medial skeleton of the valley area immediately in front of the ridge ending. If the three legs of the valley area were thinned down to a single-pixel-wide skeleton, the point of the intersection is the location of the minutia. Similarly, the location of the minutia for a bifurcation shall be the point of forking of the medial skeleton of the ridge. If the three legs of the ridge were each thinned down to a single-pixel-wide skeleton, the point where the three legs intersect is the location of the minutia. After all ridge endings have been converted to bifurcations, all of the minutiæ of the dactyloscopic image are represented as bifurcations. The X and Y pixel coordinates of the intersection of the three legs of each minutia can be directly formatted. Determination of the minutia direction can be extracted from each skeleton bifurcation. The three legs of every skeleton bifurcation shall be examined and the endpoint of each leg determined. Figure 6.1.2 illustrates the three methods used for determining the end of a leg that is based on a scanning resolution of 500 ppi. The ending is established according to the event that occurs first. The pixel count is based on a scan resolution of 500 ppi. Different scan resolutions would imply different pixel counts. — a distance of 0,064" (the 32nd pixel), — the end of skeleton leg that occurs between a distance of 0,02" and 0,064" (the 10th through the 32nd pixels); shorter legs are not used, — a second bifurcation is encountered within a distance of 0,064" (before the 32nd pixel). The angle of the minutiæ is determined by constructing three virtual rays originating at the bifurcation point and extending to the end of each leg. The smallest of the three angles formed by the rays is bisected to indicate the minutiæ direction. 6.1.3. Coordinate system The coordinate system used to express the minutiæ of a fingerprint shall be a Cartesian coordinate system. Minutiæ locations shall be represented by their x and y coordinates. The origin of the coordinate system shall be the upper left corner of the original image with x increasing to the right and y increasing downward. Both x and y coordinates of a minutiæ shall be represented in pixel units from the origin. It should be noted that the location of the origin and units of measure is not in agreement with the convention used in the definitions of the Type 9 in the ANSI/NIST-ITL 1-2000. 6.1.4. Minutiæ direction Angles are expressed in standard mathematical format, with zero degrees to the right and angles increasing in the counter clockwise direction. Recorded angles are in the direction pointing back along the ridge for a ridge ending and toward the centre of the valley for a bifurcation. This convention is 180 degrees opposite of the angle convention described in the definitions of the Type 9 in the ANSI/NIST-ITL 1-2000. 6.2. Fields for Type-9 Logical record INCITS-378 Format All fields of the Type-9 records shall be recorded as ASCII text. No binary fields are permissible in this tagged-field record. 6.2.1. Field 9.001: Logical record length (LEN) This mandatory ASCII field shall contain the length of the logical record specifying the total number of bytes, including every character of every field contained in the record. 6.2.2. Field 9.002: Image designation character (IDC) This mandatory two-byte field shall be used for the identification and location of the minutiæ data. The IDC contained in this field shall match the IDC found in the file content field of the Type-1 record. 6.2.3. Field 9.003: Impression type (IMP) This mandatory one-byte field shall describe the manner by which the dactyloscopic image information was obtained. The ASCII value of the proper code as selected from Table 4 shall be entered in this field to signify the impression type. 6.2.4. Field 9.004: Minutiæ format (FMT) This field shall contain a "U" to indicate that the minutiæ are formatted in M1-378 terms. Even though information may be encoded in accordance with the M1-378 standard, all data fields of the Type-9 record shall remain as ASCII text fields. 6.2.5. Field 9.126: CBEFF information This field shall contain three information items. The first information item shall contain the value "27" (0x1B). This is the identification of the CBEFF Format Owner assigned by the International Biometric Industry Association (IBIA) to INCITS Technical Committee M1. The <US> character shall delimit this item from the CBEFF Format Type that is assigned a value of "513" (0x0201) to indicate that this record contains only location and angular direction data without any Extended Data Block information. The <US> character shall delimit this item from the CBEFF Product Identifier (PID) that identifies the "owner" of the encoding equipment. The vendor establishes this value. It can be obtained from the IBIA website (www.ibia.org) if it is posted. 6.2.6. Field 9.127: Capture equipment identification This field shall contain two information items separated by the <US> character. The first shall contain "APPF" if the equipment used originally to acquire the image was certified to comply with Appendix F (IAFIS Image Quality Specification, 29 January 1999) of CJIS-RS-0010, the Federal Bureau of Investigation's Electronic Fingerprint Transmission Specification. If the equipment did not comply, it will contain the value of "NONE". The second information item shall contain the Capture Equipment ID which is a vendor-assigned product number of the capture equipment. A value of "0" indicates that the capture equipment ID is unreported. 6.2.7. Field 9.128: Horizontal line length (HLL) This mandatory ASCII field shall contain the number of pixels contained on a single horizontal line of the transmitted image. The maximum horizontal size is limited to 65534 pixels. 6.2.8. Field 9.129: Vertical line length (VLL) This mandatory ASCII field shall contain the number of horizontal lines contained in the transmitted image. The maximum vertical size is limited to 65534 pixels. 6.2.9. Field 9.130: Scale units (SLC) This mandatory ASCII field shall specify the units used to describe the image sampling frequency (pixel density). A "1" in this field indicates pixels per inch, or a "2" indicates pixels per centimetre. A "0" in this field indicates no scale is given. In this case, the quotient of HPS/VPS gives the pixel aspect ratio. 6.2.10. Field 9.131: Horizontal pixel scale (HPS) This mandatory ASCII field shall specify the integer pixel density used in the horizontal direction providing the SLC contains a "1" or a "2". Otherwise, it indicates the horizontal component of the pixel aspect ratio. 6.2.11. Field 9.132: Vertical pixel scale (VPS) This mandatory ASCII field shall specify the integer pixel density used in the vertical direction providing the SLC contains a "1" or a "2". Otherwise, it indicates the vertical component of the pixel aspect ratio. 6.2.12. Field 9.133: Finger view This mandatory field contains the view number of the finger associated with this record's data. The view number begins with "0" and increments by one to "15". 6.2.13. Field 9.134: Finger position (FGP) This field shall contain the code designating the finger position that produced the information in this Type-9 record. A code between 1 and 10 taken from Table 5 or the appropriate palm code from Table 10 shall be used to indicate the finger or palm position. 6.2.14. Field 9.135: Finger quality The field shall contain the quality of the overall finger minutiæ data and shall be between 0 and 100. This number is an overall expression of the quality of the finger record, and represents quality of the original image, of the minutia extraction and any additional operations that may affect the minutiæ record. 6.2.15. Field 9.136: number of minutiæ The mandatory field shall contain a count of the number of minutiæ recorded in this logical record. 6.2.16. Field 9.137: Finger minutiæ data This mandatory field has six information items separated by the <US> character. It consists of several subfields, each containing the details of single minutiae. The total number of minutiae subfields must agree with the count found in field 136. The first information item is the minutiae index number, which shall be initialised to "1" and incremented by "1" for each additional minutia in the fingerprint. The second and third information items are the "x" coordinate and "y" coordinates of the minutiae in pixel units. The fourth information item is the minutiae angle recorded in units of two degrees. This value shall be nonnegative between 0 and 179. The fifth information item is the minutiae type. A value of "0" is used to represent minutiae of type "OTHER", a value of "1" for a ridge ending and a value of "2" for a ridge bifurcation. The sixth information item represents the quality of each minutiae. This value shall range from 1 as a minimum to 100 as a maximum. A value of "0" indicates that no quality value is available. Each subfield shall be separated from the next with the use of the <RS> separator character. 6.2.17. Field 9.138: Ridge count information This field consists of a series of subfields each containing three information items. The first information item of the first subfield shall indicate the ridge count extraction method. A "0" indicates that no assumption shall be made about the method used to extract ridge counts, nor their order in the record. A "1" indicates that for each centre minutiæ, ridge count data was extracted to the nearest neighbouring minutiæ in four quadrants, and ridge counts for each centre minutia are listed together. A "2" indicates that for each centre minutiæ, ridge count data was extracted to the nearest neighbouring minutiæ in eight octants, and ridge counts for each centre minutia are listed together. The remaining two information items of the first subfield shall both contain "0". Information items shall be separated by the <US> separator character. Subsequent subfields will contain the centre minutiæ index number as the first information item, the neighbouring minutiæ index number as the second information item, and the number of ridges crossed as the third information item. Subfields shall be separated by the <RS> separator character. 6.2.18. Field 9.139: Core information This field will consist of one subfield for each core present in the original image. Each subfield consists of three information items. The first two items contain the "x" and "y" coordinate positions in pixel units. The third information item contains the angle of the core recorded in units of 2 degrees. The value shall be a nonnegative value between 0 and 179. Multiple cores will be separated by the <RS> separator character. 6.2.19. Field 9.140: Delta information This field will consist of one subfield for each delta present in the original image. Each subfield consists of three information items. The first two items contain the "x" and "y" coordinate positions in pixel units. The third information item contains the angle of the delta recorded in units of 2 degrees. The value shall be a nonnegative value between 0 and 179. Multiple cores will be separated by the <RS> separator character. 7. Type-13 variable-resolution latent image record The Type-13 tagged-field logical record shall contain image data acquired from latent images. These images are intended to be transmitted to agencies that will automatically extract or provide human intervention and processing to extract the desired feature information from the images. Information regarding the scanning resolution used, the image size, and other parameters required to process the image, are recorded as tagged-fields within the record. Table 7 Type-13 variable-resolution latent record layout Ident Cond. code Field Number Field name Char type Field size per occurrence Occur count Max byte count min. max. min max LEN M 13.001 LOGICAL RECORD LENGTH N 4 8 1 1 15 IDC M 13.002 IMAGE DESIGNATION CHARACTER N 2 5 1 1 12 IMP M 13.003 IMPRESSION TYPE A 2 2 1 1 9 SRC M 13.004 SOURCE AGENCY/ORI AN 6 35 1 1 42 LCD M 13.005 LATENT CAPTURE DATE N 9 9 1 1 16 HLL M 13.006 HORIZONTAL LINE LENGTH N 4 5 1 1 12 VLL M 13.007 VERTICAL LINE LENGTH N 4 5 1 1 12 SLC M 13.008 SCALE UNITS N 2 2 1 1 9 HPS M 13.009 HORIZONTAL PIXEL SCALE N 2 5 1 1 12 VPS M 13.010 VERTICAL PIXEL SCALE N 2 5 1 1 12 CGA M 13.011 COMPRESSION ALGORITHM A 5 7 1 1 14 BPX M 13.012 BITS PER PIXEL N 2 3 1 1 10 FGP M 13.013 FINGER POSITION N 2 3 1 6 25 RSV 13.014 RESERVED FOR FUTURE DEFINITION — — — — — — 13.019 COM O 13.020 COMMENT A 2 128 0 1 135 RSV 13.021 RESERVED FOR FUTURE DEFINITION — — — — — — 13.199 UDF O 13.200 USER-DEFINED FIELDS — — — — — — 13.998 DAT M 13.999 IMAGE DATA B 2 — 1 1 — Key for character type: N = Numeric; A = Alphabetic; AN = Alphanumeric; B = Binary 7.1. Fields for the Type-13 logical record The following paragraphs describe the data contained in each of the fields for the Type-13 logical record. Within a Type-13 logical record, entries shall be provided in numbered fields. It is required that the first two fields of the record are ordered, and the field containing the image data shall be the last physical field in the record. For each field of the Type-13 record, Table 7 lists the "condition code" as being mandatory "M" or optional "O", the field number, the field name, character type, field size, and occurrence limits. Based on a three digit field number, the maximum byte count size for the field is given in the last column. As more digits are used for the field number, the maximum byte count will also increase. The two entries in the "field size per occurrence" include all character separators used in the field. The "maximum byte count" includes the field number, the information, and all the character separators including the "GS" character. 7.1.1. Field 13.001: Logical record length (LEN) This mandatory ASCII field shall contain the total count of the number of bytes in the Type-13 logical record. Field 13.001 shall specify the length of the record including every character of every field contained in the record and the information separators. 7.1.2. Field 13.002: Image designation character (IDC) This mandatory ASCII field shall be used to identify the latent image data contained in the record. This IDC shall match the IDC found in the file content (CNT) field of the Type-1 record. 7.1.3. Field 13.003: Impression type (IMP) This mandatory one- or two-byte ASCII field shall indicate the manner by which the latent image information was obtained. The appropriate latent code choice selected from Table 4 (finger) or Table 9 (palm) shall be entered in this field. 7.1.4. Field 13.004: Source agency/ORI (SRC) This mandatory ASCII field shall contain the identification of the administration or organisation that originally captured the facial image contained in the record. Normally, the Originating Agency Identifier (ORI) of the agency that captured the image will be contained in this field. It consists of two information items in the following format: CC/agency. The first information item contains the Interpol Country Code, two alpha-numeric characters long. The second item, agency, is a free text identification of the agency, up to a maximum of 32 alpha-numeric characters. 7.1.5. Field 13.005: Latent capture date (LCD) This mandatory ASCII field shall contain the date that the latent image contained in the record was captured. The date shall appear as eight digits in the format CCYYMMDD. The CCYY characters shall represent the year the image was captured; the MM characters shall be the tens and unit values of the month; and the DD characters shall be the tens and unit values of the day in the month. For example, 20000229 represents 29 February 2000. The complete date shall be a legitimate date. 7.1.6. Field 13.006: Horizontal line length (HLL) This mandatory ASCII field shall contain the number of pixels contained on a single horizontal line of the transmitted image. 7.1.7. Field 13.007: Vertical line length (VLL) This mandatory ASCII field shall contain the number of horizontal lines contained in the transmitted image. 7.1.8. Field 13.008: Scale units (SLC) This mandatory ASCII field shall specify the units used to describe the image sampling frequency (pixel density). A "1" in this field indicates pixels per inch, or a "2" indicates pixels per centimetre. A "0" in this field indicates no scale is given. In this case, the quotient of HPS/VPS gives the pixel aspect ratio. 7.1.9. Field 13.009: Horizontal pixel scale (HPS) This mandatory ASCII field shall specify the integer pixel density used in the horizontal direction providing the SLC contains a "1" or a "2". Otherwise, it indicates the horizontal component of the pixel aspect ratio. 7.1.10. Field 13.010: Vertical pixel scale (VPS) This mandatory ASCII field shall specify the integer pixel density used in the vertical direction providing the SLC contains a "1" or a "2". Otherwise, it indicates the vertical component of the pixel aspect ratio. 7.1.11. Field 13.011: Compression algorithm (CGA) This mandatory ASCII field shall specify the algorithm used to compress greyscale images. See Appendix 39-7 for the compression codes. 7.1.12. Field 13.012: Bits per pixel (BPX) This mandatory ASCII field shall contain the number of bits used to represent a pixel. This field shall contain an entry of "8" for normal greyscale values of "0" to "255". Any entry in this field greater than "8" shall represent a greyscale pixel with increased precision. 7.1.13. Field 13.013: Finger/palm position (FGP) This mandatory tagged-field shall contain one or more of the possible finger or palm positions that may match the latent image. The decimal code number corresponding to the known or most probable finger position shall be taken from Table 5 or the most probable palm position from Table 10 and entered as a one- or two-character ASCII subfield. Additional finger and/or palm positions may be referenced by entering the alternate position codes as subfields separated by the "RS" separator character. The code "0", for "Unknown Finger", shall be used to reference every finger position from one through ten. The code "20", for "Unknown Palm", shall be used to reference every listed palmprint position. 7.1.14. Field 13.014-019: Reserved for future definition (RSV) These fields are reserved for inclusion in future revisions of this standard. None of these fields are to be used at this revision level. If any of these fields are present, they are to be ignored. 7.1.15. Field 13.020: Comment (COM) This optional field may be used to insert comments or other ASCII text information with the latent image data. 7.1.16. Field 13.021-199: Reserved for future definition (RSV) These fields are reserved for inclusion in future revisions of this standard. None of these fields are to be used at this revision level. If any of these fields are present, they are to be ignored. 7.1.17. Fields 13.200-998: User-defined fields (UDF) These fields are user-definable fields and will be used for future requirements. Their size and content shall be defined by the user and be in accordance with the receiving agency. If present they shall contain ASCII textual information. 7.1.18. Field 13.999: Image data (DAT) This field shall contain all data from a captured latent image. It shall always be assigned field number 999 and shall be the last physical field in the record. For example, "13.999:" is followed by image data in a binary representation. Each pixel of uncompressed greyscale data shall normally be quantised to eight bits (256 grey levels) contained in a single byte. If the entry in BPX Field 13.012 is greater or less than "8", the number of bytes required to contain a pixel will be different. If compression is used, the pixel data shall be compressed in accordance with the compression technique specified in the GCA field. 7.2. End of Type-13 variable-resolution latent image record For the sake of consistency, immediately following the last byte of data from Field 13.999 an "FS" separator shall be used to separate it from the next logical record. This separator shall be included in the length field of the Type-13 record. 8. Type-15 variable-resolution palmprint image record The Type-15 tagged-field logical record shall contain and be used to exchange palmprint image data together with fixed and user-defined textual information fields pertinent to the digitised image. Information regarding the scanning resolution used, the image size and other parameters or comments required to process the image are recorded as tagged-fields within the record. Palmprint images transmitted to other agencies will be processed by the recipient agencies to extract the desired feature information required for matching purposes. The image data shall be acquired directly from a subject using a live-scan device, or from a palmprint card or other media that contains the subject's palmprints. Any method used to acquire the palmprint images shall be capable of capturing a set of images for each hand. This set shall include the writer's palm as a single scanned image, and the entire area of the full palm extending from the wrist bracelet to the tips of the fingers as one or two scanned images. If two images are used to represent the full palm, the lower image shall extend from the wrist bracelet to the top of the interdigital area (third finger joint) and shall include the thenar, and hypothenar areas of the palm. The upper image shall extend from the bottom of the interdigital area to the upper tips of the fingers. This provides an adequate amount of overlap between the two images that are both located over the interdigital area of the palm. By matching the ridge structure and details contained in this common area, an examiner can confidently state that both images came from the same palm. As a palmprint transaction may be used for different purposes, it may contain one or more unique image areas recorded from the palm or hand. A complete palmprint record set for one individual will normally include the writer's palm and the full palm image(s) from each hand. Since a tagged-field logical image record may contain only one binary field, a single Type-15 record will be required for each writer's palm and one or two Type-15 records for each full palm. Therefore, four to six Type-15 records will be required to represent the subject's palmprints in a normal palmprint transaction. 8.1. Fields for the Type-15 logical record The following paragraphs describe the data contained in each of the fields for the Type-15 logical record. Within a Type-15 logical record, entries shall be provided in numbered fields. It is required that the first two fields of the record are ordered, and the field containing the image data shall be the last physical field in the record. For each field of the Type-15 record, Table 8 lists the "condition code" as being mandatory "M" or optional "O", the field number, the field name, character type, field size, and occurrence limits. Based on a three digit field number, the maximum byte count size for the field is given in the last column. As more digits are used for the field number, the maximum byte count will also increase. The two entries in the "field size per occurrence" include all character separators used in the field. The "maximum byte count" includes the field number, the information, and all the character separators including the "GS" character. 8.1.1. Field 15.001: Logical record length (LEN) This mandatory ASCII field shall contain the total count of the number of bytes in the Type-15 logical record. Field 15.001 shall specify the length of the record including every character of every field contained in the record and the information separators. 8.1.2. Field 15.002: Image designation character (IDC) This mandatory ASCII field shall be used to identify the palmprint image contained in the record. This IDC shall match the IDC found in the file content (CNT) field of the Type-1 record. 8.1.3. Field 15.003: Impression type (IMP) This mandatory one-byte ASCII field shall indicate the manner by which the palmprint image information was obtained. The appropriate code selected from Table 9 shall be entered in this field. 8.1.4. Field 15.004: Source agency/ORI (SRC) This mandatory ASCII field shall contain the identification of the administration or organisation that originally captured the facial image contained in the record. Normally, the Originating Agency Identifier (ORI) of the agency that captured the image will be contained in this field. It consists of two information items in the following format: CC/agency. The first information item contains the Interpol Country Code, two alpha-numeric characters long. The second item, agency, is a free text identification of the agency, up to a maximum of 32 alpha-numeric characters. 8.1.5. Field 15.005: Palmprint capture date (PCD) This mandatory ASCII field shall contain the date that the palmprint image was captured. The date shall appear as eight digits in the format CCYYMMDD. The CCYY characters shall represent the year the image was captured; the MM characters shall be the tens and unit values of the month; and the DD characters shall be the tens and units values of the day in the month. For example, the entry 20000229 represents 29 February 2000. The complete date shall be a legitimate date. 8.1.6. Field 15.006: Horizontal line length (HLL) This mandatory ASCII field shall contain the number of pixels contained on a single horizontal line of the transmitted image. 8.1.7. Field 15.007: Vertical line length (VLL) This mandatory ASCII field shall contain the number of horizontal lines contained in the transmitted image. 8.1.8. Field 15.008: Scale units (SLC) This mandatory ASCII field shall specify the units used to describe the image sampling frequency (pixel density). A "1" in this field indicates pixels per inch, or a "2" indicates pixels per centimetre. A "0" in this field indicates no scale is given. In this case, the quotient of HPS/VPS gives the pixel aspect ratio. 8.1.9. Field 15.009: Horizontal pixel scale (HPS) This mandatory ASCII field shall specify the integer pixel density used in the horizontal direction providing the SLC contains a "1" or a "2". Other-wise, it indicates the horizontal component of the pixel aspect ratio. 8.1.10. Field 15.010: Vertical pixel scale (VPS) This mandatory ASCII field shall specify the integer pixel density used in the vertical direction providing the SLC contains a "1" or a "2". Otherwise, it indicates the vertical component of the pixel aspect ratio. Table 8 Type-15 variable-resolution palmprint record layout Ident Cond. code Field number Field name Char type Field size per occurrence Occur count Max byte count min. max. min max LEN M 15.001 LOGICAL RECORD LENGTH N 4 8 1 1 15 IDC M 15.002 IMAGE DESIGNATION CHARACTER N 2 5 1 1 12 IMP M 15.003 IMPRESSION TYPE N 2 2 1 1 9 SRC M 15.004 SOURCE AGENCY/ORI AN 6 35 1 1 42 PCD M 15.005 PALMPRINT CAPTURE DATE N 9 9 1 1 16 HLL M 15.006 HORIZONTAL LINE LENGTH N 4 5 1 1 12 VLL M 15.007 VERTICAL LINE LENGTH N 4 5 1 1 12 SLC M 15.008 SCALE UNITS N 2 2 1 1 9 HPS M 15.009 HORIZONTAL PIXEL SCALE N 2 5 1 1 12 VPS M 15.010 VERTICAL PIXEL SCALE N 2 5 1 1 12 CGA M 15.011 COMPRESSION ALGORITHM AN 5 7 1 1 14 BPX M 15.012 BITS PER PIXEL N 2 3 1 1 10 PLP M 15.013 PALMPRINT POSITION N 2 3 1 1 10 RSV 15.014 RESERVED FOR FUTURE INCLUSION — — — — — — 15.019 COM O 15.020 COMMENT AN 2 128 0 1 128 RSV 15.021 RESERVED FOR FUTURE INCLUSION — — — — — — 15.199 UDF O 15.200 USER-DEFINED FIELDS — — — — — — 15.998 DAT M 15.999 IMAGE DATA B 2 — 1 1 — Table 9 Palm Impression Type Description Code Live-scan palm 10 Nonlive-scan palm 11 Latent palm impression 12 Latent palm tracing 13 Latent palm photo 14 Latent palm lift 15 8.1.11. Field 15.011: Compression algorithm (CGA) This mandatory ASCII field shall specify the algorithm used to compress greyscale images. An entry of "NONE" in this field indicates that the data contained in this record are uncompressed. For those images that are to be compressed, this field shall contain the preferred method for the compression of tenprint fingerprint images. Valid compression codes are defined in Appendix 39-7. 8.1.12. Field 15.012: Bits per pixel (BPX) This mandatory ASCII field shall contain the number of bits used to represent a pixel. This field shall contain an entry of "8" for normal greyscale values of "0" to "255". Any entry in this field greater than or less than "8" shall represent a greyscale pixel with increased or decreased precision respectively. Table 10 Palm Codes, Areas and Sizes Palm Position Palm code Image area (mm2) Width (mm) Height (mm) Unknown Palm 20 28387 139,7 203,2 Right Full Palm 21 28387 139,7 203,2 Right Writer s Palm 22 5645 44,5 127,0 Left Full Palm 23 28387 139,7 203,2 Left Writer s Palm 24 5645 44,5 127,0 Right Lower Palm 25 19516 139,7 139,7 Right Upper Palm 26 19516 139,7 139,7 Left Lower Palm 27 19516 139,7 139,7 Left Upper Palm 28 19516 139,7 139,7 Right Other 29 28387 139,7 203,2 Left Other 30 28387 139,7 203,2 8.1.13. Field 15.013: Palmprint position (PLP) This mandatory tagged-field shall contain the palmprint position that matches the palmprint image. The decimal code number corresponding to the known or most probable palmprint position shall be taken from Table 10 and entered as a two-character ASCII subfield. Table 10 also lists the maximum image areas and dimensions for each of the possible palmprint positions. 8.1.14. Field 15.014-019: Reserved for future definition (RSV) These fields are reserved for inclusion in future revisions of this standard. None of these fields are to be used at this revision level. If any of these fields are present, they are to be ignored. 8.1.15. Field 15.020: Comment (COM) This optional field may be used to insert comments or other ASCII text information with the palmprint image data. 8.1.16. Field 15.021-199: Reserved for future definition (RSV) These fields are reserved for inclusion in future revisions of this standard. None of these fields are to be used at this revision level. If any of these fields are present, they are to be ignored. 8.1.17. Fields 15.200-998: User-defined fields (UDF) These fields are user-definable fields and will be used for future requirements. Their size and content shall be defined by the user and be in accordance with the receiving agency. If present, they shall contain ASCII textual information. 8.1.18. Field 15.999: Image data (DAT) This field shall contain all of the data from a captured palmprint image. It shall always be assigned field number 999 and shall be the last physical field in the record. For example, "15.999:" is followed by image data in a binary representation. Each pixel of uncompressed greyscale data shall normally be quantised to eight bits (256 grey levels) contained in a single byte. If the entry in BPX Field 15.012 is greater or less than 8, the number of bytes required to contain a pixel will be different. If compression is used, the pixel data shall be compressed in accordance with the compression technique specified in the CGA field. 8.2. End of Type-15 variable-resolution palmprint image record For the sake of consistency, immediately following the last byte of data from Field 15.999 an "FS" separator shall be used to separate it from the next logical record. This separator shall be included in the length field of the Type-15 record. 8.3. Additional Type-15 variable-resolution palmprint image records Additional Type-15 records may be included in the file. For each additional palmprint image, a complete Type-15 logical record together with the "FS" separator is required. Table 11 Maximum numbers of candidates accepted for verification per transmission Type of AFIS Search TP/TP LT/TP LP/PP TP/UL LT/UL PP/ULP LP/ULP Maximum Number of Candidates 1 10 5 5 5 5 5 Search types: TP/TP: ten-print against ten-print LT/TP: fingerprint latent against ten-print LP/PP: palmprint latent against palmprint TP/UL: ten-print against unsolved fingerprint latent LT/UL: fingerprint latent against unsolved fingerprint latent PP/ULP: palmprint against unsolved palmprint latent LP/ULP: palmprint latent against unsolved palmprint latent 9. Appendices to Chapter 2 (exchange of dactyloscopic data) 9.1. Appendix 39-1: ASCII Separator Codes ASCII Position (2) Description LF 1/10 Separates error codes in Field 2.074 FS 1/12 Separates logical records of a file GS 1/13 Separates fields of a logical record RS 1/14 Separates the subfields of a record field US 1/15 Separates individual information items of the field or subfield 9.2. Appendix 39-2: Calculation of Alpha-Numeric Check Character For TCN and TCR (Fields 1.09 and 1.10): The number corresponding to the check character is generated using the following formula: (YY * 108 + SSSSSSSS) Modulo 23 Where YY and SSSSSSSS are the numerical values of the last two digits of the year and the serial number respectively. The check character is then generated from the look-up table given below. For CRO (Field 2.010) The number corresponding to the check character is generated using the following formula: (YY * 106 + NNNNNN) Modulo 23 Where YY and NNNNNN are the numerical values of the last two digits of the year and the serial number respectively. The check character is then generated from the look-up table given below. Check Character Look-up Table 1-A 9-J 17-T 2-B 10-K 18-U 3-C 11-L 19-V 4-D 12-M 20-W 5-E 13-N 21-X 6-F 14-P 22-Y 7-G 15-Q 0-Z 8-H 16-R 9.3. Appendix 39-3: Character Codes 7-bit ANSI code for information interchange ASCII Character Set + 0 1 2 3 4 5 6 7 8 9 30 ! ’ # $ % & ‘ 40 ( ) * + , - . / 0 1 50 2 3 4 5 6 7 8 9 : ; 60 < = > ? @ A B C D E 70 F G H I J K L M N O 80 P Q R S T U V W X Y 90 Z [ \ ] ^ _ ` a b c 100 d e f g h i j k l m 110 n o p q r s t u v w 120 x y z {}{ | }} ~ 9.4. Appendix 39-4: Transaction Summary Type 1 Record (mandatory) Identifier Field number Field name CPS/PMS SRE ERR LEN 1.001 Logical Record Length M M M VER 1.002 Version Number M M M CNT 1.003 File Content M M M TOT 1.004 Type of Transaction M M M DAT 1.005 Date M M M PRY 1.006 Priority M M M DAI 1.007 Destination Agency M M M ORI 1.008 Originating Agency M M M TCN 1.009 Transaction Control Number M M M TCR 1.010 Transaction Control Reference C M M NSR 1.011 Native Scanning Resolution M M M NTR 1.012 Nominal Transmitting Resolution M M M DOM 1.013 Domain name M M M GMT 1.014 Greenwich mean time M M M Under the Condition Column: O = Optional; M = Mandatory; C = Conditional if transaction is a response to the origin agency Type 2 Record (mandatory) Identifier Field number Field name CPS/PMS MPS/MMS SRE ERR LEN 2.001 Logical Record Length M M M M IDC 2.002 Image Designation Character M M M M SYS 2.003 System Information M M M M CNO 2.007 Case Number — M C — SQN 2.008 Sequence Number — C C — MID 2.009 Latent Identifier — C C — CRN 2.010 Criminal Reference Number M — C — MN1 2.012 Miscellaneous Identification Number — — C C MN2 2.013 Miscellaneous Identification Number — — C C MN3 2.014 Miscellaneous Identification Number — — C C MN4 2.015 Miscellaneous Identification Number — — C C INF 2.063 Additional Information O O O O RLS 2.064 Respondents List — — M — ERM 2.074 Status/Error Message Field — — — M ENC 2.320 Expected Number of Candidates M M — — Under the Condition Column: O = Optional; M = Mandatory; C = Conditional if data is available * = if the transmission of the data is in accordance with domestic law (not covered by Articles 533 and 534 of this Agreement) 9.5. Appendix 39-5: Type-1 Record Definitions Identifier Condition Field number Field name Character type Example data LEN M 1.001 Logical Record Length N 1.001:230{}{GS}} VER M 1.002 Version Number N 1.002:0300{}{GS}} CNT M 1.003 File Content N 1.003:1{}{US}}15{}{RS}}2{}{US}}00{}{RS}}4{}{US}}01{}{RS}}4{}{US}}02{}{RS}}4{}{US}}03{}{RS}}4{}{US}}04{}{RS}}4{}{US}}05{}{RS}}4{}{US}}06{}{RS}}4{}{US}}07{}{RS}}4{}{US}}08{}{RS}}4{}{US}}09{}{RS}}4{}{US}}10{}{RS}}4{}{US}}11{}{RS}}4{}{US}}12{}{RS}}4{}{US}}13{}{RS}}4{}{US}}14{}{GS}} TOT M 1.004 Type of Transaction A 1.004:CPS{}{GS}} DAT M 1.005 Date N 1.005:20050101{}{GS}} PRY M 1.006 Priority N 1.006:4{}{GS}} DAI M 1.007 Destination Agency 1* 1.007:DE/BKA{}{GS}} ORI M 1.008 Originating Agency 1* 1.008:NL/NAFIS{}{GS}} TCN M 1.009 Transaction Control Number AN 1.009:0200000004F{}{GS}} TCR C 1.010 Transaction Control Reference AN 1.010:0200000004F{}{GS}} NSR M 1.011 Native Scanning Resolution AN 1.011:19.68{}{GS}} NTR M 1.012 Nominal Transmitting Resolution AN 1.012:19,68{}{GS}} DOM M 1.013 Domain Name AN 1.013: INT-I{}{US}}4,22{}{GS}} GMT M 1.014 Greenwich Mean Time AN 1.014:20050101125959Z Under the Condition Column: O = Optional, M = Mandatory, C = Conditional Under the Character Type Column: A = Alpha, N = Numeric, B = Binary 1* allowed characters for agency name are ["0..9", "A..Z", "a..z", "_", ".", "", "-"] 9.6. Appendix 39-6: Type-2 Record Definitions Table A.6.1 CPS- and PMS-Transaction Identifier Condition Field number Field name Character type Example data LEN M 2.001 Logical Record Length N 2.001:909{}{GS}} IDC M 2.002 Image Designation Character N 2.002:00{}{GS}} SYS M 2.003 System Information N 2.003:0422{}{GS}} CRN M 2.010 Criminal Reference Number AN 2.010:DE/E999999999{}{GS}} INF O 2.063 Additional Information 1* 2.063:Additional Information 123{}{GS}} ENC M 2.320 Expected Number of Candidates N 2.320:1{}{GS}} Table A.6.2 SRE-Transaction Identifier Condition Field number Field name Character type Example data LEN M 2.001 Logical Record Length N 2.001:909{}{GS}} IDC M 2.002 Image Designation Character N 2.002:00{}{GS}} SYS M 2.003 System Information N 2.003:0422{}{GS}} CRN C 2.010 Criminal Reference Number AN 2.010:NL/2222222222{}{GS}} MN1 C 2.012 Miscellaneous Identification Number AN 2.012:E999999999{}{GS}} MN2 C 2.013 Miscellaneous Identification Number AN 2.013:E999999999{}{GS}} MN3 C 2.014 Miscellaneous Identification Number N 2.014:0001{}{GS}} MN4 C 2.015 Miscellaneous Identification Number A 2.015:A{}{GS}} INF O 2.063 Additional Information 1* 2.063:Additional Information 123{}{GS}} RLS M 2.064 Respondents List AN 2.064:CPS{}{RS}}I{}{RS}}001/001{}{RS}}999999{}{GS}} Table A.6.3 ERR-Transaction Identifier Condition Field number Field name Character type Example data LEN M 2.001 Logical Record Length N 2.001:909{}{GS}} IDC M 2.002 Image Designation Character N 2.002:00{}{GS}} SYS M 2.003 System Information N 2.003:0422{}{GS}} MN1 M 2.012 Miscellaneous Identification Number AN 2.012:E999999999{}{GS}} MN2 C 2.013 Miscellaneous Identification Number AN 2.013:E999999999{}{GS}} MN3 C 2.014 Miscellaneous Identification Number N 2.014:0001{}{GS}} MN4 C 2.015 Miscellaneous Identification Number A 2.015:A{}{GS}} INF O 2.063 Additional Information 1* 2.063:Additional Information 123{}{GS}} ERM M 2.074 Status/Error Message Field AN 2.074: 201: IDC - 1 FIELD 1.009 WRONG CONTROL CHARACTER {}{LF}} 115: IDC 0 FIELD 2.003 INVALID SYSTEM INFORMATION {}{GS}} Table A.6.4 MPS- and MMS-Transaction Identifier Condition Field number Field name Character type Example data LEN M 2.001 Logical Record Length N 2.001:909{}{GS}} IDC M 2.002 Image Designation Character N 2.002:00{}{GS}} SYS M 2.003 System Information N 2.003:0422{}{GS}} CNO M 2.007 Case Number AN 2.007:E999999999{}{GS}} SQN C 2.008 Sequence Number N 2.008:0001{}{GS}} MID C 2.009 Latent Identifier A 2.009:A{}{GS}} INF O 2.063 Additional Information 1* 2.063:Additional Information 123{}{GS}} ENC M 2.320 Expected Number of Candidates N 2.320:1{}{GS}} Under the Condition Column: O = Optional, M = Mandatory, C = Conditional Under the Character Type Column: A = Alpha, N = Numeric, B = Binary 1* allowed characters are ["0..9", "A..Z", "a..z", "_", ".", "", "-", ","] 9.7. Appendix 39-7: Greyscale Compression Codes Compression Codes Compression Value Remarks Wavelet Scalar Quantisation Greyscale Fingerprint Image Compression Specification IAFIS-IC-0010(V3), dated 19 December 1997 WSQ Algorithm to be used for the compression of greyscale images in Type-4, Type-7 and Type-13 to Type-15 records. Shall not be used for resolutions > 500 dpi. JPEG 2000 [ISO 15444/ITU T.800] J2K To be used for lossy and losslessly compression of greyscale images in Type-13 to Type-15 records. Strongly recommended for resolutions > 500 dpi 9.8. Appendix 39-8: Mail specification To improve the internal workflow the mail subject of a PRUEM transaction has to be filled with the country code (CC) of the State that send the message and the Type of Transaction (TOT Field 1.004). Format: CC/type of transaction Example: "DE/CPS" The mail body can be empty. CHAPTER 3 EXCHANGE OF VEHICLE REGISTRATION DATA 1. Common data-set for automated search of vehicle registration data 1.1. Definitions The definitions of mandatory and optional data elements set out in Article 14(4) of Chapter 0 are as follows: Mandatory (M): The data element has to be communicated when the information is available in a State's national register. Therefore there is an obligation to exchange the information when available. Optional (O): The data element may be communicated when the information is available in a State's national register. Therefore there is no obligation to exchange the information even when the information is available. An indication (Y) is given for each element in the data set where the element is specifically identified as important in relation with Article 537 of this Agreement. 1.2. Vehicle/owner/holder search 1.2.1. Triggers for the search There are two different ways to search for the information as defined in the next paragraph: — by Chassis Number (VIN), Reference Date and Time (optional), — by License Plate Number, Chassis Number (VIN) (optional), Reference Date and Time (optional). By means of these search criteria, information related to one and sometimes more vehicles will be returned. If information for only one vehicle has to be returned, all the items are returned in one response. If more than one vehicle is found, the requested State itself can determine which items will be returned; all items or only the items to refine the search (e.g. because of privacy reasons or because of performance reasons). The items necessary to refine the search are pictured in paragraph 1.2.2.1. In paragraph 1.2.2.2 the complete information set is described. When the search is done by Chassis Number, Reference Date and Time, the search can be done in one or all of the participating States. When the search is done by License Number, Reference Data and Time, the search has to be done in one specific State. Normally the actual Date and Time is used to make a search, but it is possible to conduct a search with a Reference Date and Time in the past. When a search is made with a Reference Date and Time in the past and historical information is not available in the register of the specific State because no such information is registered at all, the actual information can be returned with an indication that the information is actual information. 1.2.2. Data set 1.2.2.1. Items to be returned necessary for the refinement of the search Item M/O (3) Remarks Prüm Y/N (4) Data relating to vehicles Licence number M Y Chassis number/VIN M Y Country of registration M Y Make M (D.1 (5)) e.g. Ford, Opel, Renault, etc. Y Commercial type of the vehicle M (D.3) e.g. Focus, Astra, Megane Y EU Category Code M (J) mopeds, motorbikes, cars, etc. Y 1.2.2.2. Complete data set Item M/O (6) Remarks Prüm Y/N Data relating to holders of the vehicle (C.1 (7)) The data refer to the holder of the specific registration certificate. Registration holders' (company) name M (C.1.1.) separate fields will be used for surname, infixes, titles, etc., and the name in printable format will be communicated Y First name M (C.1.2) separate fields for first name(s) and initials will be used, and the name in printable format will be communicated Y Address M (C.1.3) separate fields will be used for Street, House number and Annex, Zip code, Place of residence, Country of residence, etc., and the Address in printable format will be communicated Y Gender M Male, female Y Date of birth M Y Legal entity M individual, association, company, firm, etc. Y Place of Birth O Y ID Number O An identifier that uniquely identifies the person or the company. N Type of ID Number O The type of ID Number (e.g. passport number). N Start date holdership O Start date of the holdership of the car. This date will often be the same as printed under (I) on the registration certificate of the vehicle. N End date holdership O End data of the holdership of the car. N Type of holder O If there is no owner of the vehicle (C.2) the reference to the fact that the holder of the registration certificate: — is the vehicle owner, — is not the vehicle owner, — is not identified by the registration certificate as being the vehicle owner. N Data relating to owners of the vehicle (C.2) Owners' (company) name M (C.2.1) Y First name M (C.2.2) Y Address M (C.2.3) Y Gender M male, female Y Date of birth M Y Legal entity M individual, association, company, firm, etc. Y Place of Birth O Y ID Number O An identifier that uniquely identifies the person or the company. N Type of ID Number O The type of ID Number (e.g. passport number). N Start date ownership O Start date of the ownership of the car. N End date ownership O End data of the ownership of the car. N Data relating to vehicles Licence number M Y Chassis number/VIN M Y Country of registration M Y Make M (D.1) e.g. Ford, Opel, Renault, etc. Y Commercial type of the vehicle M (D.3) e.g. Focus, Astra, Megane. Y Nature of the vehicle/EU Category Code M (J) mopeds, motorbikes, cars, etc. Y Date of first registration M (B) Date of first registration of the vehicle somewhere in the world. Y Start date (actual) registration M (I) Date of the registration to which the specific certificate of the vehicle refers. Y End date registration M End data of the registration to which the specific certificate of the vehicle refers. It is possible this date indicates the period of validity as printed on the document if not unlimited (document abbreviation = H). Y Status M Scrapped, stolen, exported, etc. Y Start date status M Y End date status O N kW O (P.2) Y Capacity O (P.1) Y Type of licence number O Regular, transito, etc. Y Vehicle document id 1 O The first unique document ID as printed on the vehicle document. Y Vehicle document id 2 (8) O A second document ID as printed on the vehicle document. Y Data relating to insurances Insurance company name O Y Begin date insurance O Y End date insurance O Y Address O Y Insurance number O Y ID number O An identifier that uniquely identifies the company. N Type of ID number O The type of ID number (e.g. number of the Chamber of Commerce) N 2. Data Security 2.1. Overview The Eucaris software application handles secure communication to the other States and communicates to the back-end legacy systems of States using XML. States exchange messages by directly sending them to the recipient. The data centre of a State is connected to the TESTA network. The XML-messages sent over the network are encrypted. The technique to encrypt these messages is SSL. The messages sent to the back-end are plain text XML-messages since the connection between the application and the back-end shall be in a protected environment. A client application is provided which can be used within a State to query their own register or other States' registers. The clients will be identified by means of user-id/password or a client certificate. The connection to a user may be encrypted, but this is the responsibility of each individual State. 2.2. Security Features related to message exchange The security design is based on a combination of HTTPS and XML signature. This alternative uses XML-signature to sign all messages sent so the server and can authenticate the sender of the message by checking the signature. 1-sided SSL (only a server certificate) is used to protect the confidentiality and integrity of the message in transit and provides protection against deletion/replay and insertion attacks. Instead of bespoke software development to implement 2-sided SSL, XML-signature is implemented. Using XML-signature is closer to the web services roadmap than 2-sided SSL and therefore more strategic. The XML-signature can be implemented in several ways but the chosen approach is to use XML Signature as part of the Web Services Security (WSS). WSS specifies how to use XML-signature. Since WSS builds upon the SOAP standard, it is logical to adhere to the SOAP standard as much as possible. 2.3. Security features not related to message exchange 2.3.1. Authentication of users The users of the Eucaris web application authenticate themselves using a username and password. Since standard Windows authentication is used, States can enhance the level of authentication of users if needed by using client certificates. 2.3.2. User roles The Eucaris software application supports different user roles. Each cluster of services has its own authorisation. E.g. (exclusive) users of the "'Treaty of Eucaris' — functionality" may not use the "'Prüm' — functionality". Administrator services are separated from the regular end-user roles. 2.3.3. Logging and tracing of message exchange Logging of all message types is facilitated by the Eucaris software application. An administrator function allows the national administrator to determine which messages are logged: requests from end-users, incoming requests from other States, provided information from the national registers, etc. The application can be configured to use an internal database for this logging, or an external (Oracle) database. The decision on what messages have to be logged clearly depends on logging facilities elsewhere in the legacy systems and connected client applications. The header of each message contains information on the requesting State, the requesting organisation within that State and the user involved. Also the reason of the request is indicated. By means of the combined logging in the requesting and responding State complete tracing of any message exchange is possible (e.g. on request of a citizen involved). Logging is configured through the Eucaris web client (menu Administration, Logging configuration). The logging functionality is performed by the Core System. When logging is enabled, the complete message (header and body) is stored in one logging record. Per defined service, and per message type that passes along the Core System, the logging level can be set. Logging Levels The following logging levels are possible: Private — Message is logged: The logging is NOT available to the extract logging service but is available on a national level only, for audits and problem solving. None — Message is not logged at all. Message Types Information exchange between States consists of several messages, of which a schematic representation is given in Figure 5 below. The possible message types (in Figure 5 shown for the Eucaris Core System of State X) are the following: 1. Request to Core System_Request message by Client; 2. Request to Other State_Request message by Core System of this State; 3. Request to Core System of this State_Request message by Core System of other State; 4. Request to Legacy Register_Request message by Core System; 5. Request to Core System_Request message by Legacy Register; 6. Response from Core System_Request message by Client; 7. Response from Other State_Request message by Core System of this State; 8. Response from Core System of this State_Request message by other State; 9. Response from Legacy Register_Request message by Core System; 10. Response from Core System_Request message by Legacy Register. The following information exchanges are shown in Figure 5: — Information request from State X to State Y — blue arrows. This request and response consists of message types 1, 2, 7 and 6, respectively, — Information request from State Z to State X — red arrows. This request and response consists of message types 3, 4, 9 and 8, respectively, — Information request from the legacy register to its core system (this route also includes a request from a custom client behind the legacy register) — green arrows. This kind of request consists of message types 5 and 10. 2.3.4. Hardware Security Module A Hardware Security Module is not used. A Hardware Security Module (HSM) provides good protection for the key used to sign messages and to identify servers. This adds to the overall level of security but an HSM is expensive to buy/maintain and there are no requirements to decide for a FIPS 140-2 level 2 or level 3 HSM. Since a closed network is used that mitigates threats effectively, it is decided not to use an HSM initially. If an HSM is necessary e.g. to obtain accreditation, it can be added to the architecture. 3. Technical conditions of the data exchange 3.1. General description of the Eucaris application 3.1.1. Overview The Eucaris application connects all participating States in a mesh network where each State communicates directly to another State. There is no central component needed for the communication to be established. The Eucaris application handles secure communication to the other States and communicates to the back-end legacy systems of States using XML. The following picture visualises this architecture. States exchange messages by directly sending them to the recipient. The data centre of a State is connected to the network used for the message exchange (TESTA). To access the TESTA network, States connect to TESTA via their national gate. A firewall shall be used to connect to the network and a router connects the Eucaris application to the firewall. Depending on the alternative chosen to protect the messages, a certificate is used either by the router or by the Eucaris application. A client application is provided which can be used within a State to query its own register or other States' registers. The client application connects to Eucaris. The clients will be identified by means of user-id/password or a client certificate. The connection to a user in an external organisation (e.g. police) may be encrypted but this is the responsibility of each individual State. 3.1.2. Scope of the system The scope of the Eucaris system is limited to the processes involved in the exchange of information between the Registration Authorities in the States and a basic presentation of this information. Procedures and automated processes in which the information is to be used, are outside the scope of the system. States can choose either to use the Eucaris client functionality or to set up their own customised client application. The table below describes which aspects of the Eucaris system are mandatory to use and/or prescribed and which are optional to use and/or free to determine by the States. Eucaris aspects M/O (9) Remark Network concept M The concept is an "any-to-any" communication. Physical network M TESTA Core application M The core application of Eucaris has to be used to connect to the other States. The following functionality is offered by the core: — Encrypting and signing of the messages; — Checking of the identity of the sender; — Authorisation of States and local users; — Routing of messages; — Queuing of asynchronous messages if the recipient service is temporally unavailable; — Multiple country inquiry functionality; — Logging of the exchange of messages; — Storage of incoming messages Client application O In addition to the core application the Eucaris II client application can be used by a State. When applicable, the core and client application are modified under auspices of the Eucaris organisation. Security concept M The concept is based on XML-signing by means of client certificates and SSL-encryption by means of service certificates. Message specifications M Every State has to comply with the message specifications as set by the Eucaris organisation and this Chapter. The specifications can only be changed by the Eucaris organisation in consultation with the States. Operation and Support M The acceptance of new States or a new functionality is under auspices of the Eucaris organisation. Monitoring and help desk functions are managed centrally by an appointed State. 3.2. Functional and Non-Functional Requirements 3.2.1. Generic functionality In this section the main generic functions have been described in general terms. No Description 1. The system allows the Registration Authorities of the States to exchange request and response messages in an interactive way. 2. The system contains a client application, enabling end-users to send their requests and presenting the response information for manual processing 3. The system facilitates "broadcasting", allowing a State to send a request to all other States. The incoming responses are consolidated by the core application in one response message to the client application (this functionality is called a "Multiple Country Inquiry"). 4. The system is able to deal with different types of messages. User roles, authorisation, routing, signing and logging are all defined per specific service. 5. The system allows the States to exchange batches of messages or messages containing a large number of requests or replies. These messages are dealt with in an asynchronous way. 6. The system queues asynchronous messages if the recipient State is temporarily unavailable and guarantees the deliverance as soon as the recipient is up again. 7. The system stores incoming asynchronous messages until they can be processed. 8. The system only gives access to Eucaris applications of other States, not to individual organisations within those other States, i.e. each Registration Authority acts as the single gateway between its national end-users and the corresponding Authorities in the other States. 9. It is possible to define users of different States on one Eucaris server and to authorise them following the rights of that State. 10. Information on the requesting State, organisation and end user are included in the messages. 11. The system facilitates logging of the exchange of messages between the different States and between the core application and the national registration systems. 12. The system allows a specific secretary, which is an organisation or State explicitly appointed for this task, to gather logged information on messages sent/received by all the participating States, in order to produce statistical reports. 13. Each State indicates itself what logged information is made available for the secretary and what information is "private". 14. The system allows the National Administrators of each State to extract statistics of use. 15. The system enables addition of new States through simple administrative tasks. 3.2.2. Usability No Description 16. The system provides an interface for automated processing of messages by back-end systems/legacy and enables the integration of the user interface in those systems (customised user-interface). 17. The system is easy to learn, self-explanatory and contains help-text. 18. The system is documented to assist States in integration, operational activities and future maintenance (e.g. reference guides, functional/technical documentation, operational guide, …). 19. The user interface is multi-lingual and offers facilities for the end-user to select a preferred language. 20. The user interface contains facilities for a Local Administrator to translate both screen-items and coded information to the national language. 3.2.3. Reliability No Description 21. The system is designed as a robust and dependable operational system which is tolerant to operator errors and which will recover cleanly from power cuts or other disasters. It shall be possible to restart the system with no or minimal loss of data. 22. The system shall give stable and reproducible results. 23. The system has been designed to function reliably. It is possible to implement the system in a configuration that guarantees an availability of 98 % (by redundancy, the use of back-up servers, etc.) in each bilateral communication. 24. It is possible to use part of the system, even during failure of some components (if State C is down, States A and B are still able to communicate). The number of single points of failure in the information chain should be minimised. 25. The recovery time after a severe failure should be less than one day. It should be possible to minimise down-time by using remote support, e.g. by a central service desk. 3.2.4. Performance No Description 26. The system can be used 24x7. This time-window (24x7) is then also required from the States' legacy systems. 27. The system responds rapidly to user requests irrespective of any background tasks. This is also required from the Parties legacy systems to ensure acceptable response time. An overall response time of 10 seconds maximum for a single request is acceptable. 28. The system has been designed as a multi-user system and in such a way that background tasks can continue while the user performs foreground tasks. 29. The system has been designed to be scaleable in order to support the potential increase of number of messages when new functionality is added or new organisations or States are added. 3.2.5. Security No Description 30. The system is suited (e.g. in its security measures) for the exchange of messages containing privacy-sensitive personal data (e.g. car owner/holders), classified as EU restricted. 31. The system is maintained in such a way that unauthorised access to the data is prevented. 32. The system contains a service for the management of the rights and permissions of national end-users. 33. States are able to check the identity of the sender (at State level), by means of XML-signing. 34. States shall explicitly authorise other States to request specific information. 35. The system provides at application level a full security and encryption policy compatible with the level of security required in such situations. Exclusiveness and integrity of the information is guaranteed by the use of XML-signing and encryption by means of SSL-tunnelling. 36. All exchange of messages can be traced by means of logging. 37. Protection is provided against deletion attacks (a third party deletes a message) and replay or insertion attacks (a third party replays or inserts a message). 38. The system makes use of certificates of a Trusted Third Party (TTP). 39. The system is able to handle different certificates per State, depending on the type of message or service. 40. The security measures at application level are sufficient to allow the use of non-accredited networks. 41. The system is able to use novice security techniques such as an XML-firewall. 3.2.6. Adaptability No Description 42. The system is extensible with new messages and new functionality. The costs of adaptations are minimal. Due to the centralised development of application components. 43. States are able to define new message types for bilateral use. Not all States are required to support all message types. 3.2.7. Support and Maintenance No Description 44. The system provides monitoring facilities for a central service-desk and/or operators concerning the network and servers in the different States. 45. The system provides facilities for remote support by a central service-desk. 46. The system provides facilities for problem analysis. 47. The system can be expanded to new States. 48. The application can easily be installed by staff with a minimum of IT-qualifications and experience. The installation procedure shall be as much as possible automated. 49. The system provides a permanent testing and acceptance environment. 50. The annual costs of maintenance and support has been minimised by adherence to market standards and by creating the application in such a way that as little support as possible from a central service-desk is required. 3.2.8. Design requirements No Description 51. The system is designed and documented for an operational lifetime of many years. 52. The system has been designed in such a way that it is independent of the network provider. 53. The system is compliant with the existing HW/SW in the States by interacting with those registration systems using open standard web service technology (XML, XSD, SOAP, WSDL, HTTP(s), Web services, WSS, X.509, etc.). 3.2.9. Applicable standards No Description 54. The system is compliant with data protection issues as stated in Regulation (EC) No 45/2001 (Articles 21, 22 and 23) and Directive 95/46/EC. 55. The system complies with the IDA Standards. 56. The system supports UTF8. CHAPTER 4 EVALUATION PROCEDURE REFERRED TO IN ARTICLE 540 Article 1 Questionnaire 1. The relevant Working Group of the Council of the European Union (the "Council Working Group") shall draw up a questionnaire concerning each of the automated data exchanges set out in Articles 527 to 539 of this Agreement. 2. As soon as the United Kingdom considers that it fulfils the prerequisites for sharing data in the relevant data category, it shall answer the relevant questionnaire. Article 2 Pilot run 1. If required, and with a view to evaluating the results of the questionnaire, the United Kingdom shall carry out a pilot run together with one or more other Member States already sharing data under Decision 2008/615/JHA. The pilot run takes place shortly before or shortly after the evaluation visit. 2. The conditions and arrangements for this pilot run shall be identified by the relevant Council Working Group and be based upon prior individual agreement with the United Kingdom. The States taking part in the pilot run shall decide on the practical details. Article 3 Evaluation visit 1. With a view to evaluating the results of the questionnaire, an evaluation visit shall take place. 2. The conditions and arrangement for this visit shall be identified by the relevant Council Working Group and be based upon prior individual agreement between the United Kingdom and the evaluation team. The United Kingdom shall enable the evaluation team to check the automated exchange of data in the data category or categories to be evaluated, in particular by organising a programme for the visit, which takes into account the requests of the evaluation team. 3. Within one month of the visit, the evaluation team shall produce a report on the evaluation visit and shall forward it to the United Kingdom for its comments. If appropriate, this report may be revised by the evaluation team on the basis of the United Kingdom's comments. 4. The evaluation team shall consist of no more than three experts, designated by the Member States taking part in the automated data exchange in the data categories to be evaluated, who have experience regarding the concerned data category, have the appropriate national security clearance to deal with these matters and are willing to take part in at least one evaluation visit in another State. The evaluation team shall also include a representative of the Commission. 5. The members of the evaluation team shall respect the confidential nature of the information they acquire when carrying out their task. Article 4 Evaluations carried out under Council Decisions 2008/615/JHA and 2008/616/JHA When carrying out the evaluation procedure as referred to in Article 540 of this Agreement and this Chapter, the Council, through the relevant Council Working Group, will take into account the results of the evaluation procedures, carried out in the context of the adoption of Council Implementing Decisions (EU) 2019/968 (10) and (EU) 2020/1188 (11). The relevant Council Working Group will decide on the necessity of carrying out the pilot run referred to in Article 540(1) of this Agreement, in Article 23(2) of Chapter 0 of this Annex, and in Article 2 of this Chapter. Article 5 Report to the Council An overall evaluation report, summarising the results of the questionnaires, the evaluation visit and, where applicable, the pilot run, shall be presented to the Council for its decision pursuant to Article 540 of this Agreement. (1) "Full designated" means the handling of rare allelle values is included. (2) This is the position as defined in the ASCII standard. (3) M = mandatory when available in national register, O = optional. (4) All the attributes specifically allocated by the States are indicated with Y. (5) Harmonised document abbreviation, see Council Directive 1999/37/EC of 29 April 1999. (6) M = mandatory when available in national register, O = optional. (7) Harmonised document abbreviation, see Council Directive 1999/37/EC of 29 April 1999. (8) In Luxembourg two separate vehicle registration document ID's are used. (9) M = mandatory to use or to comply with O = optional to use or to comply with. (10) Council Implementing Decision (EU) 2019/968 of 6 June 2019 on the launch of automated data exchange with regard to DNA data in the United Kingdom (OJ EU L 156, 13.6.2019, p. 8). (11) Council Implementing Decision (EU) 2020/1188 of 6 August 2020 on the launch of automated data exchange with regard to dactyloscopic data in the United Kingdom (OJ EU L 265, 12.8.2020, p. 1). ANNEX 40 PASSENGER NAME RECORD DATA Passenger name record data elements (as far as collected by air carriers): 1. PNR record locator; 2. Date of reservation/issue of ticket; 3. Date or dates of intended travel; 4. Name or names; 5. Address, telephone number and electronic contact information of the passenger, the persons who made the flight reservation for the passenger, persons through whom an air passenger may be contacted and persons who are to be informed in the event of an emergency; 6. All available payment/billing information (covering information relating solely to the payment methods for, and billing of, the air ticket, to the exclusion of any other information not directly relating to the flight); 7. Complete travel itinerary for specific PNR; 8. Frequent flyer information (the designator of the airline or vendor that administers the program, frequent flyer traveller number, membership level, tier description and alliance code); 9. Travel agency/travel agent; 10. Travel status of passenger, including confirmations, check-in status, no-show or go-show information; 11. Split/divided PNR information; 12. Other Supplementary Information (OSI), Special Service Information (SSI) and Special Service Request (SSR) information; 13. Ticketing field information, including ticket number, date of ticket issuance and one-way tickets, automated ticket fare quote fields; 14. Seat information, including seat number; 15. Code share information; 16. All baggage information; 17. The names of other passengers on the PNR and number of passengers on the PNR travelling together; 18. Any advance passenger information (API) data collected (type, number, country of issuance and expiry date of any identity document, nationality, family name, given name, gender, date of birth, airline, flight number, departure date, arrival date, departure port, arrival port, departure time and arrival time); 19. All historical changes to the PNR listed in points 1 to 18. ANNEX 41 FORMS OF CRIME FOR WHICH EUROPOL IS COMPETENT — Terrorism, — Organised crime, — Drug trafficking, — Money-laundering activities, — Crime connected with nuclear and radioactive substances, — Immigrant smuggling, — Trafficking in human beings, — Motor vehicle crime, — Murder and grievous bodily injury, — Illicit trade in human organs and tissue, — Kidnapping, illegal restraint and hostage-taking, — Racism and xenophobia, — Robbery and aggravated theft, — Illicit trafficking in cultural goods, including antiquities and works of art, — Swindling and fraud, — Crime against the financial interests of the Union, — Insider dealing and financial market manipulation, — Racketeering and extortion, — Counterfeiting and product piracy, — Forgery of administrative documents and trafficking therein, — Forgery of money and means of payment, — Computer crime, — Corruption, — Illicit trafficking in arms, ammunition and explosives, — Illicit trafficking in endangered animal species, — Illicit trafficking in endangered plant species and varieties, — Environmental crime, including ship-source pollution, — Illicit trafficking in hormonal substances and other growth promoters, — Sexual abuse and sexual exploitation, including child abuse material and solicitation of children for sexual purposes, — Genocide, crimes against humanity and war crimes. ANNEX 42 FORMS OF SERIOUS CRIME FOR WHICH EUROJUST IS COMPETENT — Terrorism, — Organised crime, — Drug trafficking, — Money-laundering activities, — Crime connected with nuclear and radioactive substances, — Immigrant smuggling, — Trafficking in human beings, — Motor vehicle crime, — Murder and grievous bodily injury, — Illicit trade in human organs and tissue, — Kidnapping, illegal restraint and hostage taking, — Racism and xenophobia, — Robbery and aggravated theft, — Illicit trafficking in cultural goods, including antiquities and works of art, — Swindling and fraud, — Crime against the financial interests of the Union, — Insider dealing and financial market manipulation, — Racketeering and extortion, — Counterfeiting and product piracy, — Forgery of administrative documents and trafficking therein, — Forgery of money and means of payment, — Computer crime, — Corruption, — Illicit trafficking in arms, ammunition and explosives, — Illicit trafficking in endangered animal species, — Illicit trafficking in endangered plant species and varieties, — Environmental crime, including ship source pollution, — Illicit trafficking in hormonal substances and other growth promoters, — Sexual abuse and sexual exploitation, including child abuse material and solicitation of children for sexual purposes, — Genocide, crimes against humanity and war crimes. ANNEX 43 ARREST WARRANT This warrant has been issued by a competent judicial authority. I request that the person mentioned below be arrested and surrendered for the purposes of conducting a criminal prosecution or executing a custodial sentence or detention order. (1) (a) Information regarding the identity of the requested person: Name: Forename(s): Maiden name, where applicable: Aliases, where applicable: Sex: Nationality: Date of birth: Place of birth: Residence and/or known address: Language(s) which the requested person understands (if known): Distinctive marks/description of the requested person: Photo and fingerprints of the requested person, if they are available and can be transmitted, or contact details of the person to be contacted in order to obtain such information or a DNA profile (where this evidence can be supplied but has not been included) (b) Decision on which the warrant is based: 1. Arrest warrant or judicial decision having the same effect: Type: 2. Enforceable judgement: Reference: (c) Indications on the length of the sentence: 1. Maximum length of the custodial sentence or detention order which may be imposed for the offence(s): 2. Length of the custodial sentence or detention order imposed: Remaining sentence to be served: (d) Indicate if the person appeared in person at the trial resulting in the decision: 1. ☐ Yes, the person appeared in person at the trial resulting in the decision. 2. ☐ No, the person did not appear in person at the trial resulting in the decision. 3. If you have ticked the box under point 2, please confirm the existence of one of the following, if applicable: ☐ 3.1a. the person was summoned in person on … (day/month/year) and thereby informed of the scheduled date and place of the trial which resulted in the decision and was informed that a decision may be handed down if he or she does not appear for the trial; OR ☐ 3.1b. the person was not summoned in person but by other means actually received official information of the scheduled date and place of the trial which resulted in the decision, in such a manner that it was unequivocally established that he or she was aware of the scheduled trial, and was informed that a decision may be handed down if he or she does not appear for the trial; OR ☐ 3.2. being aware of the scheduled trial, the person had given a mandate to a legal counsellor, who was either appointed by the person concerned or by the State, to defend him or her at the trial, and was indeed defended by that counsellor at the trial; OR ☐ 3.3. the person was served with the decision on … (day/month/year) and was expressly informed about the right to a retrial or appeal, in which he or she has the right to participate and which allows the merits of the case, including fresh evidence, to be re-examined, and which may lead to the original decision being reversed, and ☐ the person expressly stated that he or she does not contest this decision; OR ☐ the person did not request a retrial or appeal within the applicable timeframe; OR ☐ 3.4. the person was not personally served with the decision, but — the person will be personally served with this decision without delay after the surrender; and — when served with the decision, the person will be expressly informed of his or her right to a retrial or appeal, in which he or she has the right to participate and which allows the merits of the case, including fresh evidence, to be re-examined, and which may lead to the original decision being reversed; and — the person will be informed of the timeframe within which he or she has to request a retrial or appeal, which will be …… days. 4. If you have ticked the box under point 3.1b, 3.2 or 3.3 above, please provide information about how the relevant condition has been met: … (e) Offences: This warrant relates to in total: offences Description of the circumstances in which the offence(s) was (were) committed, including the time, place and degree of participation in the offence(s) by the requested person: Nature and legal classification of the offence(s) and the applicable statutory provision/code: I. The following applies only in case both the issuing and the executing State have made a notification under Article 599(4) of the Agreement: if applicable, tick one or more of the following offences, as defined by the law of the issuing State, punishable in the issuing State by a custodial sentence or detention order for a maximum period of at least three years: ☐ participation in a criminal organisation, ☐ terrorism as defined in Annex 45 to the Agreement, ☐ trafficking in human beings, ☐ sexual exploitation of children and child pornography, ☐ illicit trafficking in narcotic drugs and psychotropic substances, ☐ illicit trafficking in weapons, munitions and explosives, ☐ corruption, including bribery, ☐ fraud, including that affecting the financial interests of the United Kingdom, of a Member State or of the Union, ☐ laundering of the proceeds of crime, ☐ counterfeiting of currency, ☐ computer-related crime, ☐ environmental crime, including illicit trafficking in endangered animal species and in endangered plant species and varieties, ☐ facilitation of unauthorised entry and residence, ☐ murder, grievous bodily injury, ☐ illicit trade in human organs and tissue, ☐ kidnapping, illegal restraint and hostage-taking, ☐ racism and xenophobia, ☐ organised or armed robbery, ☐ illicit trafficking in cultural goods, including antiques and works of art, ☐ swindling, ☐ racketeering and extortion, ☐ counterfeiting and piracy of products, ☐ forgery of administrative documents and trafficking therein, ☐ forgery of means of payment, ☐ illicit trafficking in hormonal substances and other growth promoters, ☐ illicit trafficking in nuclear or radioactive materials, ☐ trafficking in stolen vehicles, ☐ rape, ☐ arson, ☐ crimes within the jurisdiction of the International Criminal Court, ☐ unlawful seizure of aircraft, ships or spacecraft, ☐ sabotage. II. Full descriptions of offence(s) not covered by Section I above: (f) Other circumstances relevant to the case (optional information): (NB: This could cover remarks on extraterritoriality, interruption of periods of time limitation and other consequences of the offence) (g) This warrant pertains also to the seizure and handing over of property which may be required as evidence: This warrant pertains also to the seizure and handing over of property acquired by the requested person as a result of the offence: Description of the property (and location) (if known): (h) The offence(s) on the basis of which this warrant has been issued is (are) punishable by/has(have) led to a custodial life sentence or lifetime detention order: the issuing State will upon request by the executing State give an assurance that it will: ☐ review the penalty or measure imposed – on request or at least after 20 years, and/or ☐ encourage the application of measures of clemency to which the person is entitled to apply for under the law or practice of the issuing State, aiming at a non-execution of such penalty or measure. (i) The judicial authority which issued the warrant: Official name: Name of its representative: (2) Post held (title/grade): File reference: Address: Tel. No.: (country code) (area/city code) Fax No. (country code) (area/city code) E-mail: Contact details of the person to contact to make necessary practical arrangements for the surrender: Where a central authority has been made responsible for the transmission and administrative reception of arrest warrants: Name of the central authority: Contact person, if applicable (title/grade and name): Address: Tel. No.: (country code) (area/city code) Fax No. (country code) (area/city code) E-mail: Signature of the issuing judicial authority and/or its representative: Name: Post held (title/grade): Date: Official stamp (if available): (1) This warrant must be written in, or translated into, one of the official languages of the executing State, when that State is known, or any other language accepted by that State. (2) In the different language versions a reference to the "holder" of the judicial authority will be included. ANNEX 44 EXCHANGE OF CRIMINAL RECORD INFORMATION – TECHNICAL AND PROCEDURAL SPECIFICATIONS CHAPTER 1 GENERAL PROVISIONS Article 1 Objective The objective of this Annex is to lay down the necessary procedural and technical provisions for the implementation of Title IX of Part Three of this Agreement. Article 2 Communications network 1. The electronic exchange of information extracted from the criminal record between, on the one side, a Member State and, on the other side, the United Kingdom shall take place using a common communication infrastructure that provides for encrypted communications. 2. The common communication infrastructure shall be the Trans European Services for Telematics between Administrations (TESTA) communications network. Any further developments thereof or any alternative secure network shall ensure that the common communication infrastructure in place continues to fulfil the security requirements adequate for the exchange of criminal record information. Article 3 Interconnection software 1. The States shall use a standardised interconnection software enabling the connection of their central authorities to the common communication infrastructure in order to exchange the information extracted from the criminal record with the other States electronically in accordance with the provisions of Title IX of Part Three of this Agreement and this Annex. 2. For the Member States, the interconnection software shall be the ECRIS reference implementation software or their national ECRIS implementation software, if necessary adapted for the purposes of information exchange with the United Kingdom as set out in this Agreement. 3. The United Kingdom shall be responsible for the development and operation of its own interconnection software. For that purpose, at the latest before the entry into force of this Agreement, the United Kingdom shall ensure that its national interconnection software functions in accordance with the protocols and technical specifications established for the ECRIS reference implementation software, and with any further technical requirements established by eu-LISA. 4. The United Kingdom shall also ensure the implementation of any subsequent technical adaptations to its national interconnection software required by any changes to the technical specifications established for the ECRIS reference implementation software, or changes to any further technical requirements established by eu-LISA, without undue delay. To that end, the Union shall ensure that the United Kingdom is informed without undue delay of any planned changes to the technical specifications or requirements and is provided with any information necessary for the United Kingdom to comply with its obligations under this Annex. Article 4 Information to be transmitted in notifications, requests and replies 1. All notifications referred to in Article 646 of this Agreement shall include the following obligatory information: (a) information on the convicted person (full name, date of birth, place of birth (town and State), gender, nationality and – if applicable – previous name(s)); (b) information on the nature of the conviction (date of conviction, name of the court, date on which the decision became final); (c) information on the offence giving rise to the conviction (date of the offence underlying the conviction and name or legal classification of the offence as well as reference to the applicable legal provisions); and (d) information on the contents of the conviction (notably the sentence as well as any supplementary penalties, security measures and subsequent decisions modifying the enforcement of the sentence). 2. The following optional information shall be transmitted in notifications if that information has been entered in the criminal record (points (a) to (d)) or is available to the central authority (points (e) to (h)): (a) the convicted person's parents' names; (b) the reference number of the conviction; (c) the place of the offence; (d) disqualifications arising from the conviction; (e) the convicted person's identity number, or the type and number of the person's identification document; (f) fingerprints, which have been taken from that person; (g) if applicable, pseudonym and/or alias(es); (h) facial image. In addition, any other information concerning convictions entered in the criminal record may be transmitted. 3. All requests for information referred to in Article 648 of this Agreement shall be submitted in a standardised electronic format according to the model form set out in Chapter 2 of this Annex, in one of the official languages of the requested State. 4. All replies to requests referred to in Article 649 of this Agreement shall be submitted in a standardised electronic format in accordance with the model form set out in Chapter 2 of this Annex, and accompanied by a list of convictions, as provided for by national law. The requested State shall reply either in one of its official languages or in any other language accepted by both Parties. The United Kingdom, on the one side, and the Union, on behalf of any of its Member States, on the other side, may notify to the Specialised Committee on Law Enforcement and Judicial Cooperation which language(s) it accepts in addition to the official language(s) of that State. 5. The Specialised Committee on Law Enforcement and Judicial Cooperation shall adopt any modifications to the forms in Chapter 2 of this Annex referred to in paragraphs 3 and 4 as may be necessary. Article 5 Format of transmission of information 1. When transmitting information in accordance with Article 646 and Article 649 of this Agreement relating to the name or legal classification of the offence and to the applicable legal provisions, the States shall refer to the corresponding code for each of the offences referred to in the transmission, as provided for in the table of offences in Chapter 3 of this Annex. By way of exception, if the offence does not correspond to any specific sub-category, the "open category" code of the relevant or closest category of offences or, in the absence of the latter, an "other offences" code, shall be used for that particular offence. 2. The States may also provide available information relating to the level of completion and the level of participation in the offence and, if applicable, to the existence of total or partial exemption from criminal responsibility, or to recidivism. 3. When transmitting information in accordance with Article 646 and Article 649 of this Agreement relating to the contents of the conviction, notably the sentence as well as any supplementary penalties, security measures and subsequent decisions modifying the enforcement of the sentence, the States shall refer to the corresponding code for each of the penalties and measures referred to in the transmission, as provided for in the table of penalties and measures in Chapter 3 of this Annex. By way of exception, if the penalty or measure does not correspond to any specific sub-category, the "open category" code of the relevant or closest category of penalties and measures or, in the absence of the latter, an "other penalties and measures" code, shall be used for that particular penalty or measure. 4. The States shall also provide, if applicable, available information relating to the nature and/or conditions of execution of the penalty or measure imposed as provided for in the table of parameters of Chapter 3 of this Annex. The parameter "non-criminal ruling" shall be indicated only in cases where information on such a ruling is provided on a voluntary basis by the State of nationality of the person concerned, when replying to a request for information on convictions. 5. The following information shall be provided by the States to the Specialised Committee on Law Enforcement and Judicial Cooperation, with a view in particular to disseminating this information to other States: (a) the list of national offences in each of the categories referred to in the table of offences in Chapter 3 of this Annex. The list shall include the name or legal classification of the offence and reference to the applicable legal provisions. It may also include a short description of the constitutive elements of the offence; (b) the list of types of sentences, possible supplementary penalties and security measures and possible subsequent decisions modifying the enforcement of the sentence as defined in national law, in each of the categories referred to in the table of penalties and measures in Chapter 3 of this Annex. It may also include a short description of the specific penalty or measure. 6. The lists and descriptions referred to in paragraph 5 shall be regularly updated by the States. Updated information shall be sent to the Specialised Committee on Law Enforcement and Judicial Cooperation. 7. The Specialised Committee on Law Enforcement and Judicial Cooperation shall adopt any modifications to the tables in Chapter 3 of this Annex referred to in paragraphs 1 to 4 as may be necessary. Article 6 Continuity of transmission If the electronic mode of transmission of information is temporarily not available, the States shall transmit information by any means capable of producing a written record under conditions allowing the central authority of the requested State to establish the authenticity thereof, for the entire period of such unavailability. Article 7 Statistics and reporting 1. An evaluation of the electronic exchange of information extracted from criminal records pursuant to Title IX of Part Three of this Agreement shall be carried out on a regular basis. The evaluation shall be based on the statistics and reports of the respective States. 2. Each State shall compile statistics on the exchange generated by the interconnection software and shall forward them every month to the Specialised Committee on Law Enforcement and Judicial Cooperation and to eu-LISA. The States shall also provide the Specialised Committee on Law Enforcement and Judicial Cooperation and eu-LISA with the statistics on the number of nationals of other States convicted on their territory and on the number of such convictions. Article 8 Technical specifications The States shall observe common technical specifications on the electronic exchange of information extracted from the criminal record as provided by eu-LISA in the implementation of this Agreement and shall adapt their systems as appropriate without undue delay. CHAPTER 2 FORMS Request for information extracted from the criminal record (a) Information on the requesting State: State: Central authority(ies): Contact person: Telephone (with STD code): Fax (with STD code): E-mail address: Correspondence address: File reference, if known: (b) Information on the identity of the person concerned by the request( 1 ): Full name (forenames and all surnames) Previous names: Pseudonym and/or alias, if any: Gender: M ☐ F ☐ Nationality: Date of birth (in figures: dd/mm/yyyy): Place of birth (town and State): Father's name: Mother's name: Residence or known address: Person's identity number or type and number of the person's identification document: Fingerprints: Facial image: Other available identification information: (c) Purpose of the request: Please tick the appropriate box (1) ☐ criminal proceedings (please identify the authority before which the proceedings are pending and, if available, the case reference number) … … (2) ☐ request outside the context of criminal proceedings (please identify the authority before which the proceedings are pending and, if available, the case reference number, while ticking the relevant box): (i) ☐ from a judicial authority … … (ii) ☐ from a competent administrative authority … … (iii) ☐ from the person concerned for information on own criminal record … … Purpose for which the information is requested: Requesting authority: ☐ the person concerned does not consent for this information to be divulged (if the person concerned was asked for his or her consent in accordance with the law of the requesting State). Contact person for any further information needed: Name: Telephone: E-mail address: Other information (e.g. urgency of the request): Reply to the request Information relating to the person concerned Please tick the appropriate box The undersigned authority confirms that: ☐ there is no information on convictions in the criminal record of the person concerned ☐ there is information on convictions entered in the criminal record of the person concerned; a list of convictions is attached ☐ there is other information entered in the criminal record of the person concerned; such information is attached (optional) ☐ there is information on convictions entered in the criminal record of the person concerned but the convicting State intimated that the information about these convictions may not be retransmitted for any purposes other than that of criminal proceedings. The request for more information may be sent directly to … (please indicate the convicting State) ☐ in accordance with the national law of the requested State, requests made for any purposes other than that of criminal proceedings may not be dealt with. Contact person for any further information needed: Name: Telephone: E-mail address: Other information (limitations of use of the data concerning requests outside the context of criminal proceedings): Please indicate the number of pages attached to the reply form: Done at on Signature and official stamp (if appropriate): Name and position/organisation: If appropriate, please attach a list of convictions and send the complete package to the requesting State. It is not necessary to translate the form or the list into the language of the requesting State. _______________ (1) To facilitate the identification of the person as much information as possible is to be provided. CHAPTER 3 STANDARISED FORMAT OF TRANSMISSION OF INFORMATION Common table of offences categories, with a table of parameters, referred to in Article 5(1) and (2) of Chapter 1 Code Categories and sub-categories of offences 0100 00 open category Crimes within the jurisdiction of the International Criminal Court 0101 00 Genocide 0102 00 Crimes against humanity 0103 00 War crimes 0200 00 open category Participation in a criminal organisation 0201 00 Directing a criminal organisation 0202 00 Knowingly taking part in the criminal activities of a criminal organisation 0203 00 Knowingly taking part in the non-criminal activities of a criminal organisation 0300 00 open category Terrorism 0301 00 Directing a terrorist group 0302 00 Knowingly participating in the activities of a terrorist group 0303 00 Financing of terrorism 0304 00 Public provocation to commit a terrorist offence 0305 00 Recruitment or training for terrorism 0400 00 open category Trafficking in human beings 0401 00 Trafficking in human beings for the purposes of labour or services exploitation 0402 00 Trafficking in human beings for the purposes of the exploitation of the prostitution of others or other forms of sexual exploitation 0403 00 Trafficking in human beings for the purposes of organ or human tissue removal 0404 00 Trafficking in human beings for the purposes of slavery, practices similar to slavery or servitude 0405 00 Trafficking in human beings for the purposes of labour or services exploitation of a minor 0406 00 Trafficking in human beings for the purposes of the exploitation of the prostitution of minors or other forms of their sexual exploitation 0407 00 Trafficking in human beings for the purposes of organ or human tissue removal of a minor 0408 00 Trafficking in human beings for the purposes of slavery, practices similar to slavery or servitude of a minor 0500 00 open category Illicit trafficking( 1 ) and other offences related to weapons, firearms, their parts and components, ammunition and explosives 0501 00 Illicit manufacturing of weapons, firearms, their parts and components, ammunition and explosives 0502 00 Illicit trafficking of weapons, firearms, their parts and components ammunition and explosives at national level( 2 ) 0503 00 Illicit exportation or importation of weapons, firearms, their parts and components, ammunition and explosives 0504 00 Unauthorised possession or use of weapons, firearms, their parts and components, ammunition and explosives 0600 00 open category Environmental crime 0601 00 Destroying or damaging protected fauna and flora species 0602 00 Unlawful discharges of polluting substances or ionising radiation into air, soil or water 0603 00 Offences related to waste, including hazardous waste 0604 00 Offences related to illicit trafficking( 1 ) in protected fauna and flora species or parts thereof 0605 00 Unintentional environmental offences 0700 00 open category Offences related to drugs or precursors, and other offences against public health 0701 00 Offences related to illicit trafficking( 3 ) in narcotic drugs, psychotropic substances and precursors not exclusively for own personal consumption 0702 00 Illicit consumption of drugs and their acquisition, possession, manufacture or production exclusively for own personal consumption 0703 00 Aiding or inciting others to use narcotic drugs or psychotropic substances illicitly 0704 00 Manufacture or production of narcotic drugs not exclusively for personal consumption 0800 00 open category Crimes against the person 0801 00 Intentional killing 0802 00 Aggravated cases of intentional killing( 4 ) 0803 00 Unintentional killing 0804 00 Intentional killing of a new-born by his/her mother 0805 00 Illegal abortion 0806 00 Illegal euthanasia 0807 00 Offences related to committing suicide 0808 00 Violence causing death 0809 00 Causing grievous bodily injury, disfigurement or permanent disability 0810 00 Unintentionally causing grievous bodily injury, disfigurement or permanent disability 0811 00 Causing minor bodily injury 0812 00 Unintentionally causing minor bodily injury 0813 00 Exposing to danger of loss of life or grievous bodily injury 0814 00 Torture 0815 00 Failure to offer aid or assistance 0816 00 Offences related to organ or tissue removal without authorisation or consent 0817 00 Offences related to illicit trafficking( 3 ) in human organs and tissue 0818 00 Domestic violence or threat 0900 00 open category Offences against personal liberty, dignity and other protected interests, including racism and xenophobia 0901 00 Kidnapping, kidnapping for ransom, illegal restraint 0902 00 Unlawful arrest or deprivation of liberty by public authority 0903 00 Hostage-taking 0904 00 Unlawful seizure of an aircraft or ship 0905 00 Insults, slander, defamation, contempt 0906 00 Threats 0907 00 Duress, pressure, stalking, harassment or aggression of a psychological or emotional nature 0908 00 Extortion 0909 00 Aggravated extortion 0910 00 Illegal entry into private property 0911 00 Invasion of privacy other than illegal entry into private property 0912 00 Offences against protection of personal data 0913 00 Illegal interception of data or communication 0914 00 Discrimination on grounds of gender, race, sexual orientation, religion or ethnic origin 0915 00 Public incitement to racial discrimination 0916 00 Public incitement to racial hatred 0917 00 Blackmail 1000 00 open category Sexual offences 1001 00 Rape 1002 00 Aggravated rape( 5 ) other than rape of a minor 1003 00 Sexual assault 1004 00 Procuring for prostitution or sexual act 1005 00 Indecent exposure 1006 00 Sexual harassment 1007 00 Soliciting by a prostitute 1008 00 Sexual exploitation of children 1009 00 Offences related to child pornography or indecent images of minors 1010 00 Rape of a minor 1011 00 Sexual assault of a minor 1100 00 open category Offences against family law 1101 00 Illicit sexual relations between close family members 1102 00 Polygamy 1103 00 Evading the alimony or maintenance obligation 1104 00 Neglect or desertion of a minor or a disabled person 1105 00 Failure to comply with an order to produce a minor or removal of a minor 1200 00 open category Offences against the State, public order, course of justice or public officials 1201 00 Espionage 1202 00 High treason 1203 00 Offences related to elections and referendum 1204 00 Attempt against life or health of the Head of State 1205 00 Insult of the State, Nation or State symbols 1206 00 Insult or resistance to a representative of public authority 1207 00 Extortion, duress, pressure towards a representative of public authority 1208 00 Assault or threat on a representative of public authority 1209 00 Public order offences, breach of the public peace 1210 00 Violence during sports events 1211 00 Theft of public or administrative documents 1212 00 Obstructing or perverting the course of justice, making false allegations in the course of criminal or judicial proceedings, perjury 1213 00 Unlawful impersonation of a person or an authority 1214 00 Escape from lawful custody 1300 00 open category Offences against public property or public interests 1301 00 Public, social security or family benefit fraud 1302 00 Fraud affecting European benefits or allowances 1303 00 Offences related to illegal gambling 1304 00 Obstructing of public tender procedures 1305 00 Active or passive corruption of a civil servant, a person holding public office or public authority 1306 00 Embezzlement, misappropriation or other diversion of property by a public official 1307 00 Abuse of a function by a public official 1400 00 open category Tax and customs offences 1401 00 Tax offences 1402 00 Customs offences 1500 00 open category Economic and trade related offences 1501 00 Bankruptcy or fraudulent insolvency 1502 00 Breach of accounting regulation, embezzlement, concealment of assets or unlawful increase in a company's liabilities 1503 00 Violation of competition rules 1504 00 Laundering of proceeds from crime 1505 00 Active or passive corruption in the private sector 1506 00 Revealing a secret or breaching an obligation of secrecy 1507 00 "Insider trading" 1600 00 open category Offences against property or causing damage to goods 1601 00 Unlawful appropriation 1602 00 Unlawful appropriation or diversion of energy 1603 00 Fraud, including swindling 1604 00 Dealing in stolen goods 1605 00 Illicit trafficking( 6 ) in cultural goods, including antiques and works of art 1606 00 Intentional damage or destruction of property 1607 00 Unintentional damage or destruction of property 1608 00 Sabotage 1609 00 Offences against industrial or intellectual property 1610 00 Arson 1611 00 Arson causing death or injury to persons 1612 00 Forest arson 1700 00 open category Theft offences 1701 00 Theft 1702 00 Theft after unlawful entry into property 1703 00 Theft, using violence or weapons, or using threat of violence or weapons against person 1704 00 Forms of aggravated theft which do not involve use of violence or weapons, or use of threat of violence or weapons, against persons. 1800 00 open category Offences against information systems and other computer-related crime 1801 00 Illegal access to information systems 1802 00 Illegal system interference 1803 00 Illegal data interference 1804 00 Production, possession, dissemination of or trafficking in computer devices or data enabling commitment of computer-related offences 1900 00 open category Forgery of means of payment 1901 00 Counterfeiting or forging currency 1902 00 Counterfeiting of non-cash means of payment 1903 00 Counterfeiting or forging public fiduciary documents 1904 00 Putting into circulation/using counterfeited or forged currency, non-cash means of payment or public fiduciary documents 1905 00 Possession of a device for the counterfeiting or forgery of currency or public fiduciary documents 2000 00 open category Falsification of documents 2001 00 Falsification of a public or administrative document by a private individual 2002 00 Falsification of a document by a civil servant or a public authority 2003 00 Supply or acquisition of a forged public or administrative document; supply or acquisition of a forged document by a civil servant or a public authority 2004 00 Using forged public or administrative documents 2005 00 Possession of a device for the falsification of public or administrative documents 2006 00 Forgery of private documents by a private individual 2100 00 open category Offences against traffic regulations 2101 00 Dangerous driving 2102 00 Driving under the influence of alcohol or narcotic drugs 2103 00 Driving without a licence or while disqualified 2104 00 Failure to stop after a road accident 2105 00 Avoiding a road check 2106 00 Offences related to road transport 2200 00 open category Offences against labour law 2201 00 Unlawful employment 2202 00 Offences relating to remuneration, including social security contributions 2203 00 Offences relating to working conditions, health and safety at work 2204 00 Offences relating to access to or exercise of a professional activity 2205 00 Offences relating to working hours and rest time 2300 00 open category Offences against migration law 2301 00 Unauthorised entry or residence 2302 00 Facilitation of unauthorised entry and residence 2400 00 open category Offences against military obligations 2500 00 open category Offences related to hormonal substances and other growth promoters 2501 00 Illicit importation, exportation or supply of hormonal substances and other grown promoters 2600 00 open category Offences related to nuclear materials or other hazardous radioactive substances 2601 00 Illicit importation, exportation, supply or acquisition of nuclear or radioactive materials 2700 00 open category Other offences 2701 00 Other intentional offences 2702 00 Other unintentional offences _______________ (1) Unless otherwise specified in this category, "trafficking" means import, export, acquisition, sale, delivery, movement or transfer. (2) For the purposes of this sub-category trafficking includes acquisition, sale, delivery, movement or transfer. (3) For the purposes of this sub-category trafficking includes import, export, acquisition, sale, delivery, movement or transfer. (4) For example: particularly grave circumstances. (5) For example rape with particular cruelty. (6) Trafficking includes import, export, acquisition, sale, delivery, movement or transfer. Parameters Level of completion: Completed act C Attempt or preparation A Non-transmitted element Ø Level of participation: Perpetrator M Aider and abettor or instigator/organiser, conspirator H Non-transmitted element Ø Exemption from criminal responsibility: Insanity or diminished responsibility S Recidivism R Common table of penalties and measures categories, with a table of parameters, referred to in Article 5(3) and (4) of Chapter 1 Code Categories and sub-categories of penalties and measures 1000 open category Deprivation of freedom 1001 Imprisonment 1002 Life imprisonment 2000 open category Restriction of personal freedom 2001 Prohibition from frequenting some places 2002 Restriction to travel abroad 2003 Prohibition to stay in some places 2004 Prohibition from entry to a mass event 2005 Prohibition to enter in contact with certain persons through whatever means 2006 Placement under electronic surveillance( 1 ) 2007 Obligation to report at specified times to a specific authority 2008 Obligation to stay/reside in a certain place 2009 Obligation to be at the place of residence on the set time 2010 Obligation to comply with the probation measures ordered by the court, including the obligation to remain under supervision 3000 open category Prohibition of a specific right or capacity 3001 Disqualification from function 3002 Loss/suspension of capacity to hold or to be appointed to public office 3003 Loss/suspension of the right to vote or to be elected 3004 Incapacity to contract with public administration 3005 Ineligibility to obtain public subsidies 3006 Cancellation of the driving licence( 2 ) 3007 Suspension of driving licence 3008 Prohibition to drive certain vehicles 3009 Loss/suspension of the parental authority 3010 Loss/suspension of right to be an expert in court proceedings/witness under oath/juror 3011 Loss/suspension of right to be a legal guardian( 3 ) 3012 Loss/suspension of right of decoration or title 3013 Prohibition to exercise professional, commercial or social activity 3014 Prohibition from working or activity with minors 3015 Obligation to close an establishment 3016 Prohibition to hold or to carry weapons 3017 Withdrawal of a hunting/fishing license 3018 Prohibition to issue cheques or to use payment/credit cards 3019 Prohibition to keep animals 3020 Prohibition to possess or use certain items other than weapons 3021 Prohibition to play certain games/sports 4000 open category Prohibition or expulsion from territory 4001 Prohibition from national territory 4002 Expulsion from national territory 5000 open category Personal obligation 5001 Submission to medical treatment or other forms of therapy 5002 Submission to a social-educational programme 5003 Obligation to be under the care/control of the family 5004 Educational measures 5005 Socio-judicial probation 5006 Obligation of training/working 5007 Obligation to provide judicial authorities with specific information 5008 Obligation to publish the judgment 5009 Obligation to compensate for the prejudice caused by the offence 6000 open category Penalty on personal property 6001 Confiscation 6002 Demolition 6003 Restoration 7000 open category Placing in an institution 7001 Placing in a psychiatric institution 7002 Placing in a detoxification institution 7003 Placing in an educational institution 8000 open category Financial penalty 8001 Fine 8002 Day-fine( 4 ) 8003 Fine for the benefit of a special recipient( 5 ) 9000 open category Working penalty 9001 Community service or work 9002 Community service or work accompanied with other restrictive measures 10000 open category Military penalty 10001 Loss of military rank( 6 ) 10002 Expulsion from professional military service 10003 Military imprisonment 11000 open category Exemption/deferment of sentence/penalty, warning 12000 open category Other penalties and measures Parameters (to be specified where applicable) ø Penalty m Measure a Suspended penalty/measure b Partially suspended penalty/measure c Suspended penalty/measure with probation/supervision d Partially suspended penalty/measure with probation/supervision e Conversion of penalty/measure f Alternative penalty/measure imposed as principal penalty g Alternative penalty/measure imposed initially in case of non-respect of the principal penalty h Revocation of suspended penalty/measure i Subsequent formation of an overall penalty j Interruption of enforcement/postponement of the penalty/measure( 7 ) k Remission of the penalty l Remission of the suspended penalty n End of penalty o Pardon p Amnesty q Release on parole (liberation of a person before end of the sentence under certain conditions) r Rehabilitation (with or without the deletion of penalty from criminal records) s Penalty or measure specific to minors t Non-criminal ruling( 8 ) _______________ (1) Fixed or mobile placement. (2) Reapplication in order to obtain a new driving licence is necessary. (3) Legal guardian for a person who is legally incompetent or for a minor. (4) Fine expressed in daily units. (5) E.g.: for an institution, association, foundation or a victim. (6) Military demotion. (7) Does not lead to avoidance of enforcement of penalty. (8) This parameter will be indicated only when such information is provided in reply to the request received by the State of nationality of the person concerned. ANNEX 45 DEFINITION OF TERRORISM 1. Scope For the purposes of Title IX of Part Three, point (b) of Article 599(3), Article 599(4), point (c) of Article 602(2) and point (a) of Article 670(2) of this Agreement, Annex 43 and Annex 46,"terrorism" means the offences as defined in paragraphs 3 to 14 of this Annex. 2. Definitions of terrorist group and structured group 2.1 "Terrorist group" means a structured group of more than two persons, established for a period of time and acting in concert to commit terrorist offences. 2.2 "Structured group" means a group that is not randomly formed for the immediate commission of an offence and that does not need to have formally defined roles for its members, continuity of its membership or a developed structure. 3. Terrorist offences 3.1 Intentional acts, as defined as offences under domestic law, which, given their nature or context may seriously damage a country or an international organisation where committed with one of the aims listed in paragraph 3.2: (a) attacks upon a person's life which may cause death; (b) attacks upon the physical integrity of a person; (c) kidnapping or hostage-taking; (d) causing extensive destruction to a government or public facility, a transport system, an infrastructure facility, including an information system, a fixed platform located on the continental shelf, a public place or private property likely to endanger human life or result in major economic loss; (e) seizure of aircraft, ships or other means of public or goods transport; (f) manufacture, possession, acquisition, transport, supply or use of explosives or weapons, including chemical, biological, radiological or nuclear weapons, as well as research into, and development of, chemical, biological, radiological or nuclear weapons; (g) release of dangerous substances, or causing fires, floods or explosions, the effect of which is to endanger human life; (h) interfering with or disrupting the supply of water, power or any other fundamental natural resource, the effect of which is to endanger human life; (i) seriously hindering or interrupting the functioning of an information system by inputting computer data, by transmitting, damaging, deleting, deteriorating, altering or suppressing such data, or by rendering such data inaccessible, intentionally and without right, in cases where: (i) a significant number of information systems have been affected through the use of a tool designed or adapted primarily for that purpose; (ii) the offence causes serious damage; (iii) the offence is committed against a critical infrastructure information system; (j) deleting, damaging, deteriorating, altering or suppressing computer data on an information system, or rendering such data inaccessible, intentionally and without right, in cases where the offence is committed against a critical infrastructure information system; (k) threatening to commit any of the acts listed in points (a) to (j). 3.2 The aims referred to in paragraph 3.1 are: (a) seriously intimidating a population; (b) unduly compelling a government or an international organisation to perform or abstain from performing any act; (c) seriously destabilising or destroying the fundamental political, constitutional, economic or social structures of a country or an international organisation. 4. Offences relating to a terrorist group The following intentional acts: (a) directing a terrorist group; (b) participating in the activities of a terrorist group, including by supplying information or material resources, or by funding its activities in any way, with knowledge of the fact that such participation will contribute to the criminal activities of the terrorist group. 5. Public provocation to commit a terrorist offence The distribution, or otherwise making available by any means, whether online or offline, of a message to the public, with the intent to incite the commission of one of the offences listed in points (a) to (j) of paragraph 3.1 where such conduct, directly or indirectly, such as by the glorification of terrorist acts, advocates the commission of terrorist offences, thereby causing a danger that one or more such offences may be committed when committed intentionally. 6. Recruitment for terrorism Soliciting another person to commit or contribute to the commission of one of the offences listed in points (a) to (j) of paragraph 3.1, or in paragraph 4 when committed intentionally. 7. Providing training for terrorism Providing instruction on the making or use of explosives, firearms or other weapons or noxious or hazardous substances, or on other specific methods or techniques, for the purpose of committing, or contributing to the commission of, one of the offences listed in points (a) to (j) of paragraph 3.1, knowing that the skills provided are intended to be used for this purpose when committed intentionally. 8. Receiving training for terrorism Receiving instruction on the making or use of explosives, firearms or other weapons or noxious or hazardous substances, or on other specific methods or techniques, for the purpose of committing, or contributing to the commission of, one of the offences listed in points (a) to (j) of paragraph 3.1 when committed intentionally. 9. Travelling for the purpose of terrorism 9.1 Travelling to a country other than that State for the purpose of committing, or contributing to the commission of, a terrorist offence as referred to in paragraph 3, for the purpose of the participation in the activities of a terrorist group with knowledge of the fact that such participation will contribute to the criminal activities of such a group as referred to in paragraph 4, or for the purpose of providing or receiving training for terrorism as referred to in paragraphs 7 and 8 when committed intentionally. 9.2 In addition, the following conduct when committed intentionally: (a) travelling to that State for the purpose of committing, or contributing to the commission of, a terrorist offence as referred to in paragraph 3, for the purpose of the participation in the activities of a terrorist group with knowledge of the fact that such participation will contribute to the criminal activities of such a group as referred to in paragraph 4, or for the purpose of providing or receiving training for terrorism as referred to in paragraphs 7 and 8; or (b) preparatory acts undertaken by a person entering that State with the intention to commit, or contribute to the commission of, a terrorist offence as referred to in paragraph 3.1. 10. Organising or otherwise facilitating travelling for the purpose of terrorism Any act of organisation or facilitation that assists any person in travelling for the purpose of terrorism, as referred to in paragraph 9.1 and point (a) of paragraph 9.2, knowing that the assistance thus rendered is for that purpose when committed intentionally. 11. Terrorist financing 11.1 Providing or collecting funds, by any means, directly or indirectly, with the intention that they be used, or in the knowledge that they are to be used, in full or in part, to commit, or to contribute to the commission of, any of the offences referred to in paragraphs 3 to 10 when committed intentionally. 11.2 Where the terrorist financing referred to in paragraph 11.1 concerns any of the offences laid down in paragraphs 3, 4 and 9, it shall not be necessary that the funds be in fact used, in full or in part, to commit, or to contribute to the commission of, any of those offences, nor shall it be required that the offender knows for which specific offence or offences the funds are to be used. 12. Other offences related to terrorist activities The following intentional acts: (a) aggravated theft with a view to committing one of the offences listed in paragraph 3; (b) extortion with a view to committing one of the offences listed in paragraph 3; (c) drawing up or using false administrative documents with a view to committing one of the offences listed points (a) to (j) of paragraph 3.1, point (b) of paragraph 4, and paragraph 9. 13. Relationship to terrorist offences For an offence referred to in paragraphs 4 to 12 to be considered terrorism as referred to in paragraph 1, it shall not be necessary that a terrorist act be actually committed, nor shall it be necessary, insofar as the offences referred to in paragraphs 5 to 10 and 12 are concerned, to establish a link to another specific offence laid down in this Annex. 14. Aiding and abetting, inciting and attempting The following acts: (a) aiding and abetting an offence referred to in paragraphs 3 to 8, 11 and 12; (b) inciting an offence referred to in paragraphs 3 to 12; and (c) attempting to commit an offence referred to in paragraphs 3, 6 and 7, paragraph 9.1, point (a) of paragraph 9.2, and paragraphs 11 and 12, with the exception of possession as provided for in point (f) of paragraph 3.1 and the offence referred to in point (k) of paragraph 3.1. ANNEX 46 FREEZING AND CONFISCATION Freezing / Provisional Measures Request Form SECTION A Requesting State: … Requested State: … SECTION B: Urgency Grounds for urgency and/or requested date of execution: Time limits for execution of the freezing request are set out in Article 663 of the Agreement. However, if a shorter or specific time limit is necessary, please provide the date and explain the reason for this: SECTION C: Relevant persons State all information, as far as known, regarding the identity of the (1) natural or (2) legal person(s) concerned in the freezing request or of the person(s) that owns/own the property that is covered by the freezing request (if more than one person is concerned, please provide the information for each person): 1. Natural person: Name: First name(s): Other relevant name(s), if applicable: Aliases, if applicable: Sex: Nationality: Identity number or social security number: Type and number of the identity document(s) (ID card, passport), if available: Date of birth: Place of birth: Residence and/or known address; if address not known, state the last known address: Language(s) which the person understands: Please indicate whether this person has the freezing request directed against him or her or owns the property that is covered by the freezing request: 2. Legal person: Name: Form of legal person: Shortened name, commonly used name or trading name, if applicable: Registered seat: Registration number: Address of the legal person: Name of the legal person's representative: Please indicate whether this legal person has the freezing request directed against it or owns the property that is covered by the freezing request: If different from the address above, please give the location where the freezing measure is to be carried out: 3. Third parties: (i) Third parties whose rights in relation to the property that is covered by the freezing request are directly prejudiced by the request (identity and grounds), if applicable: (ii) In case third parties have had the opportunity to claim rights, attach documents demonstrating that this has been the case. 4. Provide any other information that will assist with the execution of the freezing request: SECTION D: Relevant Property State all information, as far as known, regarding the assets subject of the freezing request. Please provide details of all property and individual items where applicable: 1. If relating to an amount of money: (i) Grounds for believing that the person has property/income in the requested State (ii) Description and location of the property/source of income of that person (iii) Exact location of the property/source of income of that person (iv) Details of the bank account of that person (if known) 2. If the freezing request concerns specific item(s) of property (or property of equivalent value to such property): (i) Grounds for believing that the specific item(s) of property is located in the requested State (ii) Description and location of the specific item(s) of property (iii) Other relevant information 3. Total amount requested for freezing or execution in the requested State (in figures and words, indicate currency): SECTION E: Grounds for request or issuing freezing order (if applicable) Summary of the facts: 1. Set out the reasons for the freezing request or why the order has been issued, including a summary of the underlying facts and grounds for freezing, a description of the criminal offence(s) charged, under investigation or subject to proceedings, the stage the investigation or proceedings have reached, the reasons for any risk factors and any other relevant information. 2. Nature and legal classification of the criminal offence(s) in relation to which the freezing request relates or the order was issued and the applicable legal provision(s). 3. The following applies only in the case(s) where both the requesting and requested State have made a notification under Article 670(2) of the Agreement: if applicable, tick one or more of the following offences, as defined by the law of the requesting State, punishable in the requesting State by a custodial sentence or detention order for a maximum period of at least three years. Where the freezing request or order concerns several criminal offences, please indicate numbers in the list of criminal offences below (corresponding to the criminal offences as described under points 1 and 2 above): ☐ participation in a criminal organisation ☐ terrorism as defined in Annex 45 ☐ trafficking in human beings ☐ sexual exploitation of children and child pornography ☐ illicit trafficking in narcotic drugs and psychotropic substances ☐ illicit trafficking in weapons, munitions and explosives ☐ corruption, including bribery ☐ fraud, including that affecting the financial interests of the United Kingdom, a Member State or the Union ☐ laundering of the proceeds of crime ☐ counterfeiting currency ☐ computer-related crime ☐ environmental crime, including illicit trafficking in endangered animal species and endangered plant species and varieties ☐ facilitation of unauthorised entry and residence ☐ murder ☐ grievous bodily injury ☐ illicit trade in human organs and tissue ☐ kidnapping, illegal restraint and hostage-taking ☐ racism and xenophobia ☐ organised or armed robbery ☐ illicit trafficking in cultural goods, including antiques and works of art ☐ swindling ☐ racketeering and extortion ☐ counterfeiting and piracy of products ☐ forgery of administrative documents and trafficking therein ☐ forgery of means of payment ☐ illicit trafficking in hormonal substances and other growth promoters ☐ illicit trafficking in nuclear or radioactive materials ☐ trafficking in stolen vehicles ☐ rape ☐ arson ☐ crimes within the jurisdiction of the International Criminal Court ☐ unlawful seizure of aircraft, ships or spacecraft ☐ sabotage 4. Any other relevant information (e.g. relation between the property and the criminal offence): SECTION F: Confidentiality ☐ Need to maintain the information in the request confidential after execution: ☐ Need for specific formalities at the time of execution: SECTION G: Requests to more than one State Where a freezing request has been transmitted to more than one State, provide the following information: 1. A freezing request has been transmitted to the following other State(s) (State and authority): 2. Please indicate the reasons for transmitting freezing requests to multiple States: 3. Value of assets, if known, in each requested State: 4. Please indicate any specific needs: SECTION H: Relation to earlier freezing requests or orders If applicable, provide information relevant to identify previous or related freezing requests: 1. Date of request or issue and transmission of order: 2. Authority to which it was transmitted: 3. Reference given by the issuing and executing authorities: SECTION I: Confiscation This freezing request is accompanied by a confiscation order issued in the requesting State (reference number of the confiscation order): ☐ Yes, reference number: ☐ No The property shall remain frozen in the requested State pending the transmission and execution of the confiscation order (estimated date for submission of the confiscation order, if possible): SECTION J: Legal remedies (if applicable) Please indicate if a legal remedy can be sought in the requesting State against the issuing of a freezing request/order, and if so please provide further details (description of the legal remedy, including necessary steps to take and deadlines): SECTION K: Issuing Authority If there is a freezing order in the requesting state upon which this freezing request is based, please provide the following details: 1. Type of issuing authority: ☐ judge, court, public prosecutor ☐ another competent authority designated by the requesting State 2. Contact details: Official name of the issuing authority: Name of its representative: Post held (title/grade): File no: Address: Tel. No: (country code) (area/city code) Fax No: (country code) (area/city code) E-mail: Languages in which it is possible to communicate with the issuing authority: Signature of the issuing authority and/or its representative certifying the content of the Freezing/Provisional Measures Request Form as accurate and correct: Name: Post held (title/grade): Date: Official stamp (if available): SECTION L: Validating Authority Please indicate the type of authority which has validated the Freezing/Provisional Measures Request Form, if applicable: ☐ judge, court, public prosecutor ☐ another competent authority designated by the requesting State Official name of the validating authority: Name of its representative: Post held (title/grade): File no: Address: Tel. No: (country code) (area/city code) Fax No: (country code) (area/city code) E-mail: Languages in which it is possible to communicate with the competent authority: SECTION M: Central Authority Please indicate the central authority responsible for the administrative transmission and receipt of freezing requests in the requesting State: Official name of the central authority: Name of its representative: Post held (title/grade): File no: Address: Tel. No: (country code) (area/city code) Fax No: (country code) (area/city code) E-mail: Languages in which it is possible to communicate with the competent authority: SECTION N: Further information 1. Please indicate if the main contact point in the requesting State should be the: ☐ issuing authority ☐ competent authority ☐ central authority 2. If different from above, please provide the contact details of the person(s) to contact for additional information regarding this freezing request: Name/Title/Organisation: Address: E-mail/Contact Phone No: SECTION O: Annexes The original or duly authenticated copy of the freezing order must be provided with the Freezing/Provisional Measures Request Form if a freezing order has been issued in the requesting State. Confiscation Request Form SECTION A Requesting State: … Requested State: … SECTION B: Confiscation order Date of issue: … Date order became final: … Reference number: … Total amount of order in figures and words, indicate currency Amount requested for execution in requested State, or if specific type(s) of property, description and location of property Please provide details of the court findings in relation to the confiscation order: ☐ property is the proceeds of an offence, or equivalent to the full or part of the value of such proceeds ☐ property constitutes instrumentalities of such an offence ☐ property is liable to extended confiscation ☐ property is subject to confiscation under any other provisions relating to powers of confiscation, including confiscation without a final conviction, under the law of the requesting State following proceedings in relation to a criminal offence SECTION C: Affected persons State all information, as far as known, regarding the identity of the (1) natural or (2) legal person(s) affected by the confiscation request (if more than one person is concerned, please provide the information for each person): 1. Natural person: Name: First name(s): Other relevant name(s), if applicable: Aliases, if applicable: Sex: Nationality: Identity number or social security number: Type and number of the identity document(s) (ID card, passport), if available: Date of birth: Place of birth: Residence and/or known address; if address not known, state the last known address: Language(s) which the person understands: Please indicate whether this person has the confiscation request directed against him or her or owns the property that is covered by the confiscation request: 2. Legal person: Name: Form of legal person: Shortened name, commonly used name or trading name, if applicable: Registered seat: Registration number: Address of the legal person: Name of the legal person's representative: If different from the address above, please give the location where the confiscation request is to be carried out: 3. Third parties: (i) Third parties whose rights in relation to the property that is covered by the confiscation request are directly prejudiced by the request (identity and grounds), if known/applicable: (ii) In case third parties have had the opportunity to claim rights, attach documents demonstrating that this has been the case. 4. Provide any other information that will assist with the execution of the confiscation request: SECTION D: Affected Property State all information, as far as known, regarding the assets subject to the confiscation. Please provide details of all property and individual items where applicable: 1. If relating to amount of money: (i) Grounds for believing that the person has property/income in the requested State: (ii) Description and location of the property/source of income: 2. If the request concerns specific item(s) of property: (i) Grounds for believing that the specific item(s) of property is/are located in the requested State: (ii) Description and location of the specific item(s) of property: 3. Value of property: (i) Total amount of request (approximate amount): (ii) Total amount requested for execution in the requested State (approximate amount): (iii) If specific type(s) of property, description and location of property: SECTION E: Grounds for confiscation Summary of the facts: 1. Set out the reasons why a confiscation order has been issued, including a summary of the underlying facts and grounds for confiscation, a description of offences, the reasons for any risk factors and any other relevant information (such as date, place and circumstances of the offence): 2. Nature and legal classification of the offence(s) in relation to which the confiscation order was issued and the applicable legal provision(s): 3. The following applies only in the case where both the requesting and requested State have made a notification under Article 670(2) of the Agreement: if applicable, tick one or more of the following offences, as defined by the law of the requesting State, punishable in the requesting State by a custodial sentence or detention order for a maximum period of at least three years. Where the confiscation order concerns several criminal offences, please indicate numbers in the list of criminal offences below (corresponding to the criminal offences as described under points 1 and 2 above): ☐ participation in a criminal organisation ☐ terrorism as defined in Annex 45 ☐ trafficking in human beings ☐ sexual exploitation of children and child pornography ☐ illicit trafficking in narcotic drugs and psychotropic substances ☐ illicit trafficking in weapons, munitions and explosives ☐ corruption, including bribery ☐ fraud, including that affecting the financial interests of the United Kingdom, a Member State or the Union ☐ laundering of the proceeds of crime ☐ counterfeiting currency ☐ computer-related crime ☐ environmental crime, including illicit trafficking in endangered animal species and endangered plant species and varieties ☐ facilitation of unauthorised entry and residence ☐ murder ☐ grievous bodily injury ☐ illicit trade in human organs and tissue ☐ kidnapping, illegal restraint and hostage-taking ☐ racism and xenophobia ☐ organised or armed robbery ☐ illicit trafficking in cultural goods, including antiques and works of art ☐ swindling ☐ racketeering and extortion ☐ counterfeiting and piracy of products ☐ forgery of administrative documents and trafficking therein ☐ forgery of means of payment ☐ illicit trafficking in hormonal substances and other growth promoters ☐ illicit trafficking in nuclear or radioactive materials ☐ trafficking in stolen vehicles ☐ rape ☐ arson ☐ crimes within the jurisdiction of the International Criminal Court ☐ unlawful seizure of aircraft, ships or spacecraft ☐ sabotage 4. Any other relevant information (e.g. relation between the property and the criminal offence): SECTION F: Confidentiality ☐ Need to maintain the information in the request or part of it confidential Please indicate any relevant information: SECTION G: Requests to more than one State Where a confiscation request has been transmitted to more than one State, provide the following information: 1. A confiscation request has been transmitted to the following other State(s) (State and authority): 2. Reasons for transmitting confiscation request to multiple States (select appropriate reasons): (i) If a request concerns specific items of property: ☐ Different items of property covered by the request are believed to be located in different States ☐ The confiscation request relates to a specific item of property and requires action in more than one State (ii) If the confiscation request concerns an amount of money: ☐ The estimated value of the property which may be confiscated in the requesting State and in any one requested State is not likely to be sufficient to cover the full amount set out in the order ☐ Other specific needs: 3. Value of assets, if known, in each requested State: 4. If confiscation of the specific item(s) of property requires action in more than one State, description of the action to be taken in the requested State: SECTION H: Conversion and transfer of property 1. If the confiscation request concerns a specific item of property, confirm whether the requesting State allows for the confiscation in the requested State to take the form of a requirement to pay a sum of money corresponding to the value of the property: ☐ Yes ☐ No 2. If the confiscation concerns an amount of money, state whether property, other than money obtained from the execution of the confiscation request, may be transferred to the requesting State: ☐ Yes ☐ No SECTION I: Imprisonment in default or other measures restricting the liberty of a person Please indicate whether the requesting State allows for the application by the requested State of imprisonment in default or other measures restricting the liberty of a person where it is not possible to execute the confiscation request, either wholly or partially: ☐ Yes ☐ No SECTION J: Restitution or victim compensation 1. Please indicate, where relevant: ☐ An issuing authority or another competent authority of the requesting State has issued a decision to compensate the victim with, or restitute to the victim, the following sum of money: ☐ An issuing authority or another competent authority of the requesting State has issued a decision to restitute the following property other than money to the victim: 2. Details of the decision to restitute property to, or compensate, the victim: Issuing authority (official name): Date of the decision: Reference number of the decision (if available): Description of the property to be restituted or amount awarded in compensation: Name of the victim: Address of the victim: SECTION K: Legal remedies Please indicate if a legal remedy has already been sought against the issuing of a confiscation order, and if so please provide further details (description of the legal remedy, including necessary steps to take and deadlines): SECTION L: Issuing Authority Please provide details on the authority which issued the confiscation request in the requesting State: 1. Type of the issuing authority: ☐ judge, court, public prosecutor ☐ another competent authority designated by the requesting State 2. Contact details: Official name of the issuing authority: Name of its representative: Post held (title/grade): File no: Address: Tel. No: (country code) (area/city code) Fax No: (country code) (area/city code) E-mail: Languages in which it is possible to communicate with the issuing authority: Signature of the issuing authority and/or its representative certifying the content of the Confiscation Request Form as accurate and correct: Name: Post held (title/grade): Date: Official stamp (if available): SECTION M: Validating Authority Please indicate the type of authority which has validated the Confiscation Request Form, if applicable: ☐ judge, court, public prosecutor ☐ another competent authority designated by the issuing State Official name of the validating authority: Name of its representative: Post held (title/grade): File no: Address: Tel. No: (country code) (area/city code) Fax No: (country code) (area/city code) E-mail: Languages in which it is possible to communicate with the competent authority: SECTION N: Central Authority Please indicate the central authority responsible for the administrative transmission and receipt of the Confiscation Request Form in the requesting State: Official name of the central authority: Name of its representative: Post held (title/grade): File no: Address: Tel. No: (country code) (area/city code) Fax No: (country code) (area/city code) E-mail: Languages in which it is possible to communicate with the competent authority: SECTION O: Further information 1. Please indicate if the main contact point in the requesting State should be the: ☐ issuing authority ☐ competent authority ☐ central authority 2. If different from above, please provide the contact details of the person(s) to contact for additional information regarding this Confiscation Request Form: Name/ Title/ Organisation: Address: E-mail/Contact Phone No: SECTION P: Annexes The original or duly authenticated copy of the confiscation order must be provided with the Confiscation Request Form. ANNEX 47 IMPLEMENTATION OF THE FINANCIAL CONDITIONS 1. The Commission shall communicate to the United Kingdom, as soon as possible and at the latest on 16 April of the financial year, the following information for each Union programme, activity, or part thereof, in which the United Kingdom participates: (a) the amounts in commitment appropriations in the Union budget definitively adopted for the year in question for the budget lines covering participation of the United Kingdom in accordance with the Protocol referred to in Article 710 of this Agreement and, if relevant, the amount of external assigned revenue appropriations that do not result from financial contribution from other donors on these budget lines; (b) the amount of the participation fee referred to in Article 714(4) of this Agreement; (c) from year N + 1 of implementation of a programme included in the Protocol referred to in Article 710 of this Agreement, the implementation of commitment appropriations corresponding to budgetary year N and the level of decommitment; (d) for programmes to which Article 716 of this Agreement applies, for the part of the programmes where such information is necessary to calculate the automatic correction, the level of commitments entered into in favour of United Kingdom entities broken down according to the corresponding year of budgetary appropriations and the related total level of commitments. On the basis of its Draft Budget, the Commission shall provide an estimate of information under points (a) and (b) as soon as possible, and, at the latest, by 1 September of the financial year. 2. The Commission shall issue, at the latest on 16 April and on 16 July of each financial year, a call for funds to the United Kingdom that corresponds to the contribution of the United Kingdom under this Agreement for each of the programmes, activities, or parts thereof, in which the United Kingdom participates. 3. The United Kingdom shall pay the amount indicated in the call for funds at the latest 60 days after the call for funds is issued. The United Kingdom may make separate payments for each programme and activity. 4. By derogation from paragraphs 2 and 3, for the year 2021 in which the Protocol referred to in Article 710 of this Agreement is concluded, the Commission shall issue a call for funds at the latest on 16 April 2021 if the Protocol is signed on or before 31 March 2021, or at the latest on the 16th of the month following the month in which the Protocol was signed if it is signed after 31 March 2021. If that call for funds is issued after 16 July of the year in question, there shall be a single call for funds for this year. The United Kingdom shall pay the amount indicated in the call for funds at the latest 60 days after the call for funds is issued. The United Kingdom may make separate payments for each programme and activity. 5. The call for funds for a given year shall have the value established by dividing the annual amount calculated in application of Article 714 of this Agreement, including any adjustment under Article 714(8), Article 716 or 717 of this Agreement, by the number of calls for funds for that year pursuant to paragraphs 2 and 4 of this Annex. 6. By way of derogation from paragraph 5, in relation to the contribution to Horizon Europe for the multiannual financial framework 2021-2027, the call for funds for a given year N shall have the value established by dividing: (a) the annual amount calculated (i) by applying the following payment schedule for payments if year N is: — 2021: 50 % paid in 2021, 50 % paid in 2026 — 2022: 50 % paid in 2022, 50 % paid in 2027 (ii) on the amount resulting from the application of Articles 714 and 716 of this Agreement, including any adjustment under Article 714(8) or Article 716 of this Agreement for that year N, by (b) the number of calls for funds for that year N pursuant to paragraphs 2 and 4: The application of this paragraph has no bearing on establishing the calculation of the automatic correction under Articles 716 and 721. For all the calculations of other amounts related to Part V of this Agreement, the annual contribution of the United Kingdom shall take into account this paragraph . 7. Where the participation of the United Kingdom is terminated pursuant to Article 719 or Article 720 of this Agreement any payments in relation to the period before the termination takes effect, which were postponed in accordance with paragraph 6 of this Annex, shall become due. The Commission shall issue a call for funds in relation to the amount due at the latest one month after the termination takes effect. The United Kingdom shall pay this due amount within 60 days of the issue of the call for funds. 8. The Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (1) ("Financial Regulation") applicable to the general budget of the European Union shall apply to the management of the appropriations. 9. In the absence of payment by the United Kingdom by the due date, the Commission shall send a formal letter of reminder. Any delay in the payment of the contribution shall give rise to the payment of default interest by the United Kingdom on the outstanding amount as from the due date until the day on which that outstanding amount is paid in full. The interest rate for amounts receivable but not paid on the due date shall be the rate applied by the European Central Bank to its principal refinancing operations, as published in the C series of the Official Journal of the European Union, in force on the first day of the month in which the due date falls, or 0 per cent, whichever is higher, plus three and a half percentage points. (1) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ EU L 193, 30.7.2018, p. 1). ANNEX 48 RULES OF PROCEDURE FOR DISPUTE SETTLEMENT I. Definitions 1. For the purposes of Title I of Part Six of this Agreement and of these Rules of Procedure, the following definitions apply: (a) "administrative staff", in respect of an arbitrator, means individuals under the direction and control of an arbitrator, other than assistants; (b) "adviser" means an individual retained by a Party to advise or assist that Party in connection with the arbitration proceedings; (c) "arbitration tribunal" means a tribunal established under Article 740 of this Agreement; (d) "arbitrator" means a member of the arbitration tribunal; (e) "assistant" means an individual who, under the terms of appointment and under the direction and control of an arbitrator, conducts research or provides assistance to that arbitrator; (f) "complaining Party" means any Party that requests the establishment of an arbitration tribunal under Article 739 of this Agreement; (g) "registry" means an external body with relevant expertise appointed by the Parties to provide administrative support for the proceedings; (h) "respondent Party" means the Party that is alleged to be in violation of the covered provisions; and (i) "representative of a Party" means an employee or any individual appointed by a government department, agency or any other public entity of a Party who represents the Party for the purposes of a dispute under this Agreement or any supplementing agreement. II. Notifications 2. Any request, notice, written submission or other document of: (a) the arbitration tribunal shall be sent to both Parties at the same time; (b) a Party, which is addressed to the arbitration tribunal, shall be copied to the other Party at the same time; and (c) a Party, which is addressed to the other Party, shall be copied to the arbitration tribunal at the same time, as appropriate. 3. Any notification referred to in rule 2 shall be made by e-mail or, where appropriate, any other means of telecommunication that provides a record of the sending thereof. Unless proven otherwise, such notification shall be deemed to be delivered on the date of its sending. 4. All notifications shall be addressed to the Legal Service of the European Commission and to the Legal Adviser of the Foreign, Commonwealth & Development Office of the United Kingdom, respectively. 5. Minor errors of a clerical nature in a request, notice, written submission or other document related to the arbitration tribunal proceedings may be corrected by delivery of a new document clearly indicating the changes. 6. If the last day for delivery of a document falls on a non-working day of the institutions of the Union or of the government of the United Kingdom, the time period for the delivery of the document shall end on the first following working day. III. Appointment of arbitrators 7. If pursuant to Article 740 of this Agreement, an arbitrator is selected by lot, the co-chair of the Partnership Council of the complaining Party shall promptly inform the co-chair of the respondent Party of the date, time and venue of the lot. The respondent Party may, if it so chooses, be present during the lot. In any event, the lot shall be carried out with the Party or Parties that are present. 8. The co-chair of the complaining Party shall notify, in writing, each individual who has been selected to serve as an arbitrator of his or her appointment. Each individual shall confirm his or her availability to both Parties within five days from the date on which he or she was informed of his or her appointment. 9. The co-chair of the Partnership Council of the complaining Party shall select by lot the arbitrator or chairperson, within five days from the expiry of the time period referred to in Article 740(2) of this Agreement, if any of the sub-lists referred in Article 752(1) of this Agreement: (a) is not established, amongst those individuals who have been formally proposed by one or both Parties for the establishment of that particular sub-list; or (b) no longer contains at least five individuals, amongst those individuals who remain on that particular sub-list. 10. The Parties may appoint a registry to assist in the organisation and conduct of specific dispute settlement proceedings on the basis of ad-hoc arrangements or on the basis of arrangements adopted by the Partnership Council pursuant to Article 759 of this Agreement. To that end, the Partnership Council shall consider no later than 180 days after the entry into force of this Agreement whether there are any necessary amendments to these Rules of Procedure. IV. Organisational Meeting 11. Unless the Parties agree otherwise, they shall meet the arbitration tribunal within seven days of its establishment in order to determine such matters that the Parties or the arbitration tribunal deem to be appropriate, including: (a) if not determined earlier, the remuneration and expenses to be paid to the arbitrators, which shall in any case be in accordance with WTO standards; (b) the remuneration to be paid to assistants; the total amount of the remuneration of an assistant or assistants of each arbitrator shall not exceed 50 % of the remuneration of that arbitrator; (c) the timetable of the proceedings; and (d) ad-hoc procedures to protect confidential information. Arbitrators and representatives of the Parties may take part in this meeting via telephone or video conference. V. Written Submissions 12. The complaining Party shall deliver its written submission no later than 20 days after the date of establishment of the arbitration tribunal. The respondent Party shall deliver its written submission no later than 20 days after the date of delivery of the written submission of the complaining Party. VI. Operation of the arbitration tribunal 13. The chairperson of the arbitration tribunal shall preside at all its meetings. The arbitration tribunal may delegate to the chairperson the authority to make administrative and procedural decisions. 14. Unless otherwise provided in Title I of Part Six of this Agreement or in these Rules of Procedure, the arbitration tribunal may conduct its activities by any means, including telephone, facsimile transmissions or computer links. 15. Only arbitrators may take part in the deliberations of the arbitration tribunal, but the arbitration tribunal may permit their assistants to be present at its deliberations. 16. The drafting of any ruling, decision and report shall remain the exclusive responsibility of the arbitration tribunal and shall not be delegated. 17. Where a procedural question arises that is not covered by Title I of Part Six of this Agreement and its Annexes, the arbitration tribunal, after consulting the Parties, may adopt an appropriate procedure that is compatible with those provisions. 18. When the arbitration tribunal considers that there is a need to modify any of the time periods for the proceedings other than the time periods set out in Title I of Part Six of this Agreement or to make any other procedural or administrative adjustment, it shall inform the Parties, in writing and after consultation of the Parties, of the reasons for the change or adjustment and of the time period or adjustment needed. VII. Replacement 19. When a Party considers that an arbitrator does not comply with the requirements of Annex 49 and for that reason should be replaced, that Party shall notify the other Party within 15 days from when it obtained sufficient evidence of the arbitrator's alleged failure to comply with the requirements of that Annex. 20. The Parties shall consult within 15 days of the notification referred to in rule 19. They shall inform the arbitrator of his or her alleged failure and they may request the arbitrator to take steps to ameliorate the failure. They may also, if they so agree, remove the arbitrator and select a new arbitrator in accordance with Article 740 of this Agreement. 21. If the Parties fail to agree on the need to replace the arbitrator, other than the chairperson of the arbitration tribunal, either Party may request that this matter be referred to the chairperson of the arbitration tribunal, whose decision shall be final. If the chairperson of the arbitration tribunal finds that the arbitrator does not comply with the requirements of Annex 49, the new arbitrator shall be selected in accordance with Article 740 of this Agreement. 22. If the Parties fail to agree on the need to replace the chairperson, either Party may request that this matter be referred to one of the remaining members of the pool of individuals from the sub-list of chairpersons established under Article 752 of this Agreement. His or her name shall be drawn by lot by the co-chair of the Partnership Council from the requesting Party, or the chair's delegate. The decision by the selected person on the need to replace the chairperson shall be final. If this person finds that the chairperson does not comply with the requirements of Annex 49, the new chairperson shall be selected in accordance with Article 740 of this Agreement. VIII. Hearings 23. On the basis of the timetable determined pursuant to rule 11, after consulting with the Parties and the other arbitrators, the chairperson of the arbitration tribunal shall notify the Parties of the date, time and venue of the hearing. That information shall be made publicly available by the Party in which the hearing takes place, unless the hearing is closed to the public. 24. Unless the Parties agree otherwise, the hearing shall be held in London if the complaining Party is the Union and in Brussels if the complaining Party is the United Kingdom. The respondent Party shall bear the expenses derived from the logistical administration of the hearing. 25. The arbitration tribunal may convene additional hearings if the Parties so agree. 26. All arbitrators shall be present during the entirety of the hearing. 27. Unless the Parties agree otherwise, the following persons may attend the hearing, irrespective of whether the hearing is open to the public or not: (a) representatives of a Party; (b) advisers; (c) assistants and administrative staff; (d) interpreters, translators and court reporters of the arbitration tribunal; and (e) experts, as decided by the arbitration tribunal pursuant to Article 751(2) of this Agreement. 28. No later than five days before the date of a hearing, each Party shall deliver to the arbitration tribunal and to the other Party a list of the names of persons who will make oral arguments or presentations at the hearing on behalf of that Party and of other representatives and advisers who will be attending the hearing. 29. The arbitration tribunal shall conduct the hearing in the following manner, ensuring that the complaining Party and the respondent Party are afforded equal time in both argument and rebuttal argument: Argument (a) argument of the complaining Party; (b) argument of the respondent Party. Rebuttal Argument (a) reply of the complaining Party; (b) counter-reply of the respondent Party. 30. The arbitration tribunal may direct questions to either Party at any time during the hearing. 31. The arbitration tribunal shall arrange for a transcript of the hearing to be prepared and delivered to the Parties as soon as possible after the hearing. The Parties may comment on the transcript and the arbitration tribunal may consider those comments. 32. Each Party may deliver a supplementary written submission concerning any matter that arises during the hearing within 10 days after the date of the hearing. IX. Questions in Writing 33. The arbitration tribunal may at any time during the proceedings submit questions in writing to one or both Parties. Any questions submitted to one Party shall be copied to the other Party. 34. Each Party shall provide the other Party with a copy of its responses to the questions submitted by the arbitration tribunal. The other Party shall have an opportunity to provide comments in writing on the Party's responses within five days after the delivery of such copy. X. Confidentiality 35. Each Party and the arbitration tribunal shall treat as confidential any information submitted by the other Party to the arbitration tribunal that the other Party has designated as confidential. When a Party submits to the arbitration tribunal a written submission which contains confidential information, it shall also provide, within 15 days, a submission without the confidential information which shall be disclosed to the public. 36. Nothing in these Rules of Procedure shall preclude a Party from disclosing statements of its own positions to the public to the extent that, when making reference to information submitted by the other Party, it does not disclose any information designated by the other Party as confidential. 37. The arbitration tribunal shall hold the relevant parts of the session in private when the submission and arguments of a Party contains confidential information. The Parties shall maintain the confidentiality of the arbitration tribunal hearings when the hearings are held in closed session. XI. Ex parte contacts 38. The arbitration tribunal shall not meet or communicate with a Party in the absence of the other Party. 39. An arbitrator shall not discuss any aspect of the subject matter of the proceedings with a Party or both Parties in the absence of the other arbitrators. XII. Amicus curiae submissions 40. Unless the Parties agree otherwise within five days of the date of the establishment of the arbitration tribunal, the arbitration tribunal may receive unsolicited written submissions from natural persons of a Party or legal persons established in the territory of a Party that are independent from the governments of the Parties, provided that they: (a) are received by the arbitration tribunal within 10 days of the date of the establishment of the arbitration tribunal; (b) are concise and in no case longer than 15 pages, including any annexes, typed at double space; (c) are directly relevant to a factual or a legal issue under consideration by the arbitration tribunal; (d) contain a description of the person making the submission, including for a natural person his or her nationality and for a legal person its place of establishment, the nature of its activities, its legal status, general objectives and its source of financing; (e) specify the nature of the interest that the person has in the arbitration proceedings; and (f) are drafted in English. 41. The submissions shall be delivered to the Parties for their comments. The Parties may submit comments, within 10 days of the delivery, to the arbitration tribunal. 42. The arbitration tribunal shall list in its report all the submissions it has received pursuant to rule 40. The arbitration tribunal shall not be obliged to address in its report the arguments made in such submissions, however, if it does, it shall also take into account any comments made by the Parties pursuant to rule 41. XIII. Urgent cases 43. In cases of urgency referred to in Article 744 of this Agreement, the arbitration tribunal, after consulting the Parties, shall adjust, as appropriate, the time periods referred to in these Rules of Procedure. The arbitration tribunal shall notify the Parties of such adjustments. XIV. Translation and interpretation 44. The language of proceedings before the arbitration tribunal shall be English. Rulings, reports and decisions of the arbitration tribunal shall be issued in English. 45. Each party shall bear its own costs of the translation of any documents submitted to the arbitration tribunal which are not originally drafted in English, as well as any costs relating to interpretation during the hearing related to its representatives or advisers. XV. Other Procedures 46. The time periods laid down in these Rules of Procedure shall be adjusted in accordance with the special time periods provided for the adoption of a report or decision by the arbitration tribunal in the proceedings provided for in Articles 747 to 750 of this Agreement. ANNEX 49 CODE OF CONDUCT FOR ARBITRATORS I. Definitions 1. For the purposes of this Code of Conduct, the following definitions apply: (a) "administrative staff" means, in respect of an arbitrator, individuals under the direction and control of an arbitrator, other than assistants; (b) "arbitrator" means a member of an arbitration tribunal; (c) "assistant" means an individual who, under the terms of appointment of an arbitrator, conducts research or provides assistance to that arbitrator; and (d) "candidate" means an individual whose name is on a list of arbitrators referred to in Article 752 of this Agreement or who is under consideration for selection as an arbitrator under Article 740 of this Agreement. II. Governing Principles 2. In order to preserve the integrity and impartiality of the dispute settlement mechanism, each candidate and arbitrator shall: (a) get acquainted with this Code of Conduct; (b) be independent and impartial; (c) avoid direct or indirect conflicts of interest; (d) avoid impropriety and the appearance of impropriety or bias; (e) observe high standards of conduct; and (f) not be influenced by self-interest, outside pressure, political considerations, public clamour, and loyalty to a Party or fear of criticism. 3. An arbitrator shall not, directly or indirectly, incur any obligation or accept any benefit that would in any way interfere, or appear to interfere, with the proper performance of his or her duties. 4. An arbitrator shall not use his or her position on the arbitration tribunal to advance any personal or private interests. An arbitrator shall avoid actions that may create the impression that others are in a special position to influence him or her. 5. An arbitrator shall not allow past or existing financial, business, professional, personal, or social relationships or responsibilities to influence his or her conduct or judgement. 6. An arbitrator shall avoid entering into any relationship or acquiring any financial interest that is likely to affect his or her impartiality or that might reasonably create an appearance of impropriety or bias. III. Disclosure obligations 7. Prior to the acceptance of his or her appointment as an arbitrator under Article 740 of this Agreement, a candidate requested to serve as an arbitrator shall disclose any interest, relationship or matter that is likely to affect his or her independence or impartiality or that might reasonably create an appearance of impropriety or bias in the proceedings. To that end, a candidate shall make all reasonable efforts to become aware of any such interests, relationships and matters, including financial interests, professional interests, or employment or family interests. 8. The disclosure obligation under paragraph 7 is a continuing duty which requires an arbitrator to disclose any such interests, relationships or matters that may arise during any stage of the proceedings. 9. A candidate or an arbitrator shall communicate to the Partnership Council for consideration by the Parties any matters concerning actual or potential violations of this Code of Conduct at the earliest time he or she becomes aware of them. IV. Duties of Arbitrators 10. Upon acceptance of his or her appointment, an arbitrator shall be available to perform and shall perform his or her duties thoroughly and expeditiously throughout the proceedings, and with fairness and diligence. 11. An arbitrator shall consider only the issues raised in the proceedings and which are necessary for a decision and shall not delegate that duty to any other person. 12. An arbitrator shall take all appropriate steps to ensure that his or her assistants and administrative staff are aware of, and comply with, the obligations incurred by arbitrators under Parts II, III, IV and VI of this Code of Conduct. V. Obligations of Former Arbitrators 13. Each former arbitrator shall avoid actions that may create the appearance that he or she was biased in carrying out the duties or derived advantage from the decision of the arbitration tribunal. 14. Each former arbitrator shall comply with the obligations in Part VI of this Code of Conduct. VI. Confidentiality 15. An arbitrator shall not, at any time, disclose any non-public information concerning the proceedings or acquired during the proceedings for which he or she has been appointed. An arbitrator shall not, in any case, disclose or use such information to gain personal advantage or advantage for others or to adversely affect the interests of others. 16. An arbitrator shall not disclose a decision of the arbitration tribunal or parts thereof prior to its publication in accordance with Title I of Part Six of this Agreement. 17. An arbitrator shall not, at any time, disclose the deliberations of an arbitration tribunal, or any arbitrator's view, nor make any statements on the proceedings for which he or she has been appointed or on the issues in dispute in the proceedings. VII. Expenses 18. Each arbitrator shall keep a record and render a final account of the time devoted to the proceedings and of his or her expenses, as well as the time and expenses of his or her assistants and administrative staff. PROTOCOL ON ADMINISTRATIVE COOPERATION AND COMBATING FRAUD IN THE FIELD OF VALUE ADDED TAX AND ON MUTUAL ASSISTANCE FOR THE RECOVERY OF CLAIMS RELATING TO TAXES AND DUTIES TITLE I GENERAL PROVISIONS Article PVAT.1 Objective The objective of this Protocol is to establish the framework for administrative cooperation between the Member States and the United Kingdom, in order to enable their authorities to assist each other in ensuring compliance with VAT legislation and in protecting VAT revenue and in recovering claims relating to taxes and duties. Article PVAT.2 Scope 1. This Protocol lays down rules and procedures for cooperation: (a) to exchange any information that may help to effect a correct assessment of VAT, monitor the correct application of VAT, and combat VAT fraud; and (b) for the recovery of: (i) claims relating to VAT, customs duties and excise duties, levied by or on behalf of a State or its territorial or administrative subdivisions, excluding the local authorities, or on behalf of the Union; (ii) administrative penalties, fines, fees and surcharges relating to the claims referred to in point (i) imposed by the administrative authorities that are competent to levy the taxes or duties concerned or carry out administrative enquiries with regard to them, or confirmed by administrative or judicial bodies at the request of those administrative authorities; and (iii) interest and costs relating to the claims referred to in points (i) and (ii). 2. This Protocol does not affect the application of the rules on administrative cooperation and combating fraud in the field of VAT and assistance for the recovery of claims between Member States. 3. This Protocol does not affect the application of the rules on mutual assistance in criminal matters. Article PVAT.3 Definitions For the purpose of this Protocol, the following definitions apply: (a) "administrative enquiry" means all the controls, checks and other action taken by the States in the performance of their duties with a view to ensuring the proper application of the VAT legislation; (b) "applicant authority" means a central liaison office or a liaison department of a State which makes a request under Title III; (c) "automatic exchange" means the systematic communication of predefined information to another State, without prior request; (d) "by electronic means" means using electronic equipment for the processing (including digital compression) and storage of data, and employing wires, radio transmission, optical technologies or other electromagnetic means; (e) "CCN/CSI network" means the common platform based on the common communication network ("CCN") and common system interface ("CSI"), developed by the Union to ensure all transmissions by electronic means between competent authorities in the area of taxation; (f) "central liaison office" means the office designated pursuant to Article PVAT.4(2) with the principal responsibility for contacts for the application of Title II or Title III; (g) "competent authority" means the authority designated pursuant to Article PVAT.4(1); (h) "competent official" means any official designated pursuant to Article PVAT.4(4) who can directly exchange information under Title II; (i) "customs duties" means the duty payable on goods entering or leaving the customs territory of each Party in accordance with the rules set out in the customs legislation of the respective Parties; (j) "excise duties" means those duties and charges defined as such under the domestic legislation of the State in which the applicant authority is located; (k) "liaison department" means any office other than the central liaison office designated as such pursuant to Article PVAT.4(3) to request or grant mutual assistance under Title II or Title III; (l) "person" means any person as defined in point (l) of Article 512 of this Agreement; (1) (m) "requested authority" means the central liaison office, the liaison department or, as far as cooperation under Title II is concerned, the competent official who receives a request from a requesting or an applicant authority; (n) "requesting authority" means a central liaison office, a liaison department or a competent official who makes a request for assistance under Title II, on behalf of a competent authority; (o) "simultaneous control" means the coordinated checking of the tax situation of a taxable person or of two or more related taxable persons organised by two or more States with common or complementary interests; (p) "Specialised Committee" means the Trade Specialised Committee on Administrative Cooperation in VAT and Recovery of Taxes and Duties; (q) "spontaneous exchange" means the non-systematic communication, at any moment and without prior request, of information to another State; (r) "State" means a Member State or the United Kingdom, as the context requires; (s) "third country" means a country that is neither a Member State nor the United Kingdom; (t) "VAT" means value added tax pursuant to Council Directive 2006/112/EC on the common system of value added tax for the Union and means value added tax pursuant to the Value Added Tax Act 1994 for the United Kingdom. Article PVAT.4 Organisation 1. Each State shall designate a competent authority responsible for the application of this Protocol. 2. Each State shall designate: (a) one central liaison office with the principal responsibility for the application of Title II of this Protocol; and (b) one central liaison office with the principal responsibility for the application of Title III of this Protocol. 3. Each competent authority may designate, directly or by delegation: (a) liaison departments to exchange directly information under Title II of this Protocol; (b) liaison departments to request or grant mutual assistance under Title III of this Protocol, in relation to their specific territorial or operational competences. 4. Each competent authority may designate, directly or by delegation, competent officials who can directly exchange information on the basis of Title II of this Protocol 5. Each central liaison office shall keep the list of liaison departments and competent officials up-to-date and make it available to the other central liaison offices. 6. Where a liaison department or a competent official sends or receives a request for assistance under this Protocol, it shall inform its central liaison office thereof. 7. Where a central liaison office, a liaison department or a competent official receives a request for mutual assistance requiring action outside its competence, it shall forward the request without delay to the competent central liaison office or liaison department, and shall inform the requesting or applicant authority thereof. In such a case, the period laid down in Article PVAT.8 shall start the day after the request for assistance has been forwarded to the competent central liaison office or the competent liaison department. 8. Each Party shall inform the Specialised Committee of its competent authorities for the purposes of this Protocol within one month of the signature of this Agreement and of any changes regarding those competent authorities without delay. The Specialised Committee shall keep the list of competent authorities updated. Article PVAT.5 Service level agreement A service level agreement ensuring the technical quality and quantity of the services for the functioning of the communication and information exchange systems shall be concluded according to a procedure established by the Specialised Committee. Article PVAT.6 Confidentiality 1. Any information obtained by a State under this Protocol shall be treated as confidential and shall be protected in the same manner as information obtained under its domestic law. 2. Such information may be disclosed to persons or authorities (including courts and administrative or supervisory bodies) concerned with the application of VAT laws and for the purpose of a correct assessment of VAT as well as for the purpose of applying enforcement measures including recovery or precautionary measures with regard to claims referred to in point (b) of Article PVAT.2(1). 3. The information referred to in paragraph 1 may also be used for assessment of other taxes and for assessment and enforcement, including recovery or precautionary measures, with regard to claims relating to compulsory social security contributions. If the information exchanged reveals or helps to prove the existence of breaches of the tax law, it may also be used for imposing administrative or criminal sanctions. Only the persons or authorities mentioned in paragraph 2 may use the information and then only for purposes set out in the preceding sentences of this paragraph. They may disclose it in public court proceedings or in judicial decisions. 4. Notwithstanding paragraphs 1 and 2, the State providing the information shall, on the basis of a reasoned request, permit its use for purposes other than those referred to in Article PVAT.2(1) by the State which receives the information if, under the legislation of the State providing the information, the information may be used for similar purposes. The requested authority shall accept or refuse any such request within one month. 5. Reports, statements and any other documents, or certified true copies or extracts thereof, obtained by a State under the assistance provided by this Protocol may be invoked as evidence in that State on the same basis as similar documents provided by another authority of that State. 6. Information provided by a State to another State may be transmitted by the latter to another State, subject to prior authorisation by the competent authority from which the information originated. The State of origin of the information may oppose such a sharing of information within ten working days of the date on which it received the communication from the State wishing to share the information. 7. The States may transmit information obtained in accordance with this Protocol to third countries subject to the following conditions: (a) the competent authority from which the information originates has consented to that transmission; and (b) the transmission is permitted by assistance arrangements between the State transmitting the information and that particular third country. 8. When a State receives information from a third country, the States may exchange that information, in so far as permitted by the assistance arrangements with that particular third country. 9. Each State shall immediately notify the other States concerned regarding any breach of confidentiality, and any sanctions and remedial actions consequently imposed. 10. Persons duly accredited by the Security Accreditation Authority of the European Commission may have access to this information only in so far as it is necessary for care, maintenance and development of the electronic systems hosted by the Commission and used by the States to implement this Protocol. TITLE II ADMINISTRATIVE COOPERATION AND COMBATING VAT FRAUD CHAPTER ONE EXCHANGE OF INFORMATION ON REQUEST Article PVAT.7 Exchange of information and administrative enquiries 1. At the request of the requesting authority, the requested authority shall communicate the information referred to in point (a) of Article PVAT.2(1), including any information relating to a specific case or cases. 2. For the purpose of forwarding the information referred to in paragraph 1, the requested authority shall arrange for the conduct of any administrative enquiries necessary to obtain such information. 3. The request referred to in paragraph 1 may contain a reasoned request for a specific administrative enquiry. The requested authority shall undertake the administrative enquiry in consultation with the requesting authority where necessary. If the requested authority takes the view that no administrative enquiry is necessary, it shall immediately inform the requesting authority of the reasons thereof. 4. Where the requested authority refuses to undertake an administrative enquiry into amounts that were declared or amounts that should have been declared by a taxable person established in the State of the requested authority in connection with supplies of goods or services and imports of goods which are made by that taxable person and which are taxable in the State of the requesting authority, the requested authority shall at least provide to the requesting authority the dates and values of any relevant supplies and imports made by the taxable person in the State of the requesting authority over the previous two years, unless the requested authority does not hold and is not required to hold this information under domestic legislation. 5. In order to obtain the information sought or to conduct the administrative enquiry requested, the requested authority or the administrative authority to which it has recourse shall proceed as though acting on its own account or at the request of another authority in its own State. 6. At the request of the requesting authority, the requested authority shall communicate to it any pertinent information it obtains or has in its possession as well as the results of administrative enquiries, in the form of reports, statements and any other documents, or certified true copies or extracts thereof. 7. Original documents shall be provided only where this is not contrary to the provisions in force in the State of the requested authority. Article PVAT.8 Time limit for providing information 1. The requested authority shall provide the information referred to in Article PVAT.7 as quickly as possible and no later than 90 days following the date of receipt of the request. However, where the requested authority is already in possession of that information, the time limit shall be reduced to a maximum period of 30 days. 2. In certain special categories of cases, time limits which are different from those provided for in paragraph 1 may be agreed between the requested and the requesting authorities. 3. Where the requested authority is unable to respond to the request within the time limits referred to in paragraphs 1 and 2, it shall forthwith inform the requesting authority in writing of the reasons for its failure to do so, and when it considers it would be likely to be able to respond. CHAPTER TWO EXCHANGE OF INFORMATION WITHOUT PRIOR REQUEST Article PVAT.9 Types of exchange of information The exchange of information without prior request shall either be spontaneous exchanges, as provided for in Article PVAT.10, or automatic exchanges, as provided for in Article PVAT.11. Article PVAT.10 Spontaneous exchange of information The competent authority of a State shall, without prior request, forward to the competent authority of another State the information referred to in point (a) of Article PVAT.2(1) which has not been forwarded under the automatic exchange referred to in Article PVAT.11 and of which it is aware of in the following cases: (a) where taxation is deemed to take place in another State and information is necessary for the effectiveness of the control system of that State; (b) where a State has grounds to believe that a breach of VAT legislation has been committed or is likely to have been committed in the other State; (c) where there is a risk of tax loss in the other State. Article PVAT.11 Automatic exchange of information 1. The categories of information subject to automatic exchange shall be determined by the Specialised Committee in accordance with Article PVAT.39. 2. A State may abstain from taking part in the automatic exchange of one or more categories of information referred to in paragraph 1 where the collection of information for such exchange would require the imposition of new obligations on persons liable for VAT or would impose a disproportionate administrative burden on that State. 3. Each State shall notify the Specialised Committee in writing of its decision taken in accordance with the previous paragraph. CHAPTER THREE OTHER FORMS OF COOPERATION Article PVAT.12 Administrative notification 1. The requested authority shall, at the request of the requesting authority and in accordance with the rules governing the notification of similar instruments and decisions in the State of the requested authority, notify the addressee of all instruments and decisions which have been sent from the requesting authorities and concern the application of VAT legislation in the State of the requesting authority. 2. Requests for notification, mentioning the subject of the instrument or decision to be notified, shall indicate the name, address and any other relevant information for identifying the addressee. 3. The requested authority shall inform the requesting authority immediately of its response to the request for notification and notify it, in particular, of the date of notification of the decision or instrument to the addressee. Article PVAT.13 Presence in administrative offices and participation in administrative enquiries 1. By agreement between the requesting authority and the requested authority, and in accordance with the arrangements laid down by the latter, the requested authority may allow officials authorised by the requesting authority to be present in the offices of the requested authority, or any other place where those authorities carry out their duties, with a view to exchanging the information referred to in point (a) of Article PVAT.2(1). Where the requested information is contained in documentation to which the officials of the requested authority have access, the officials of the requesting authority shall be given copies thereof on request. 2. By agreement between the requesting authority and the requested authority, and in accordance with the arrangements laid down by the latter, the requested authority may allow officials authorised by the requesting authority to be present during the administrative enquiries carried out in the territory of the State of the requested authority, with a view to exchanging the information referred to in point (a) of Article PVAT.2(1). Such administrative enquiries shall be carried out exclusively by the officials of the requested authority. The officials of the requesting authority shall not exercise the powers of inspection conferred on officials of the requested authority. They may, however, have access to the same premises and documents as the latter, through the intermediation of the officials of the requested authority and for the sole purpose of carrying out the administrative enquiry. 3. By agreement between the requesting authorities and the requested authority, and in accordance with the arrangements laid down by the latter, officials authorised by the requesting authorities may take part in the administrative enquiries carried out in the territory of the requested State with a view to collecting and exchanging the information referred to in point (a) of Article PVAT.2(1). Such administrative enquiries shall be carried out jointly by the officials of the requesting and requested authorities and shall be conducted under the direction and according to the legislation of the requested State. The officials of the requesting authorities shall have access to the same premises and documents as the officials of the requested authority and, in so far as it is permitted under the legislation of the requested State for its officials, shall be able to interview taxable persons. Where it is permitted under the legislation of the requested State, the officials of the requesting States shall exercise the same inspection powers as those conferred on officials of the requested State. The inspection powers of the officials of the requesting authorities shall be exercised for the sole purpose of carrying out the administrative enquiry. By agreement between the requesting authorities and the requested authority and in accordance with the arrangements laid down by the requested authority, the participating authorities may draft a common enquiry report. 4. The officials of the requesting authority present in another State in accordance with paragraphs 1, 2 and 3 must at all times be able to produce written authority stating their identity and their official capacity. Article PVAT.14 Simultaneous controls 1. The States may agree to conduct simultaneous controls whenever they consider such controls to be more effective than controls carried out by only one State. 2. A State shall identify independently the taxable persons which it intends to propose for a simultaneous control. The competent authority of that State shall notify the competent authority of the other State concerned of the cases proposed for a simultaneous control. It shall give reasons for its choice, as far as possible, by providing the information which led to its decision. It shall specify the period of time during which such controls should be conducted. 3. A competent authority that receives the proposal for a simultaneous control shall confirm its agreement or communicate its reasoned refusal to the counterpart authority, in principle within two weeks of receipt of the proposal, but within a month of receipt of the proposal at the latest. 4. Each competent authority concerned shall appoint a representative to be responsible for supervising and coordinating the control operation. CHAPTER FOUR GENERAL PROVISIONS Article PVAT.15 Conditions governing the exchange of information 1. The requested authority shall provide a requesting authority with the information referred to in point (a) of Article PVAT.2(1) or carry out an administrative notification referred to in Article PVAT.12, provided that: (a) the number and nature of the requests for information or administrative notification made by the requesting authority do not impose a disproportionate administrative burden on that requested authority; and (b) the requesting authority has exhausted the usual sources of information which it could have used in the circumstances to obtain the information requested or measures which it could reasonably have taken to carry out the administrative notification requested, without running the risk of jeopardising the achievement of the desired end. 2. This Protocol shall impose no obligation to have enquiries carried out or to provide information on a particular case if the laws or administrative practices of the State which would have to supply the information do not authorise that State to carry out those enquiries or collect or use that information for its own purposes. 3. A requested authority may refuse to provide information where the requesting authority is unable, for legal reasons, to provide similar information. The requested authority shall inform the Specialised Committee of the grounds for the refusal. 4. The provision of information may be refused where it would lead to the disclosure of a commercial, industrial or professional secret or of a commercial process, or of information whose disclosure would be contrary to public policy. 5. Paragraphs 2, 3 and 4 should in no case be interpreted as authorising the requested authority to refuse to supply information on the sole grounds that this information is held by a bank, other financial institution, nominee or person acting in an agency or fiduciary capacity or because it relates to ownership interests in a legal person. 6. The requested authority shall inform the requesting authority of the grounds for refusing a request for assistance. Article PVAT.16 Feedback Where a competent authority provides information pursuant to Article PVAT.7 or PVAT.10, it may request the competent authority which receives the information to give feedback thereon. If such request is made, the competent authority which receives the information shall, without prejudice to the rules on tax secrecy and data protection applicable in its State, send feedback as soon as possible, provided that this does not impose a disproportionate administrative burden on it. Article PVAT.17 Language Requests for assistance, including requests for notification and attached documents, shall be made in a language agreed between the requested and requesting authority. Article PVAT.18 Statistical data 1. By 30 June each year, the Parties shall communicate by electronic means to the Specialised Committee statistical data on the application of this Title. 2. The content and format of the statistical data to be communicated under paragraph 1 shall be determined by the Specialised Committee. Article PVAT.19 Standard forms and means of communication 1. Any information communicated pursuant to Articles PVAT.7, PVAT.10, PVAT.11, PVAT.12 and PVAT.16 and the statistics communicated pursuant to Article PVAT.18 shall be provided using a standard form referred to in point (d) of Article PVAT.39(2), except in the cases referred to in Article PVAT.6(7) and (8) or in specific cases where the respective competent authorities deem other secure means more appropriate and agree to use those means. 2. The standard forms shall be transmitted, in so far as possible, by electronic means. 3. Where the request has not been lodged completely through the electronic systems, the requested authority shall confirm receipt of the request by electronic means without delay and, in any event, no later than five working days after receipt. 4. Where an authority has received a request or information of which it is not the intended recipient, it shall send a message by electronic means to the sender without delay and, in any event, no later than five working days after receipt. 5. Pending the adoption by the Specialised Committee of the decisions referred to in Article PVAT.39(2), the competent authorities shall make use of the rules set out in the Annex to this Protocol, including the standard forms. TITLE III RECOVERY ASSISTANCE CHAPTER ONE EXCHANGE OF INFORMATION Article PVAT.20 Request for information 1. At the request of the applicant authority, the requested authority shall provide any information which is foreseeably relevant to the applicant authority in the recovery of its claims as referred to in point (b) of Article PVAT.2(1). The request for information shall include, where available, the name and any other data relevant to the identification of the persons concerned. For the purpose of providing that information, the requested authority shall arrange for the carrying-out of any administrative enquiries necessary to obtain it. 2. The requested authority shall not be obliged to supply information: (a) which it would not be able to obtain for the purpose of recovering similar claims on its own behalf; (b) which would disclose any commercial, industrial or professional secrets; or (c) the disclosure of which would be liable to prejudice the security of or be contrary to the public policy of the State of the requested authority. 3. Paragraph 2 shall in no case be construed as permitting a requested authority to decline to supply information solely because this information is held by a bank, other financial institution, nominee or person acting in an agency or a fiduciary capacity or because it relates to ownership interests in a legal person. 4. The requested authority shall inform the applicant authority of the grounds for refusing a request for information. Article PVAT.21 Exchange of information without prior request Where a refund of taxes or duties relates to a person established or resident in another State, the State from which the refund is to be made may inform the State of establishment or residence of the pending refund. Article PVAT.22 Presence in administrative offices and participation in administrative enquiries 1. By agreement between the applicant authority and the requested authority, and in accordance with the arrangements laid down by the latter, officials authorised by the applicant authority may, with a view to promoting mutual assistance provided for in this Title: (a) be present in the offices where officials of the requested State carry out their duties; (b) be present during administrative enquiries carried out in the territory of the requested State; and (c) assist the competent officials of the requested State during court proceedings in that State. 2. In so far as it is permitted under applicable legislation in the requested State, the agreement referred to in point (b) of paragraph 1 may provide that officials of the applicant authority may interview individuals and examine records. 3. Officials authorised by the applicant authority who make use of the possibility offered by paragraphs 1 and 2 must at all times be able to produce written authority stating their identity and their official capacity. CHAPTER TWO ASSISTANCE FOR THE NOTIFICATION OF DOCUMENTS Article PVAT.23 Request for notification of certain documents relating to claims 1. At the request of the applicant authority, the requested authority shall notify to the addressee all documents, including those of a judicial nature, which have been sent from the State of the applicant authority and which relate to a claim as referred to in point (b) of Article PVAT.2(1) or to its recovery. The request for notification shall be accompanied by a standard form containing at least the following information: (a) name, address and other data relevant to the identification of the addressee; (b) the purpose of the notification and the period within which notification should be effected; (c) a description of the attached document and the nature and amount of the claim concerned; and (d) name, address and other contact details regarding: (i) the office responsible with regard to the attached document; and (ii) if different, the office where further information can be obtained concerning the notified document or concerning the possibilities for contesting the payment obligation. 2. The applicant authority shall make a request for notification pursuant to this Article only when it is unable to notify in accordance with the rules governing the notification of the document concerned in its own State or when such notification would give rise to disproportionate difficulties. 3. The requested authority shall forthwith inform the applicant authority of any action taken on its request for notification and in particular of the date of notification of the document to the addressee. Article PVAT.24 Means of notification 1. The requested authority shall ensure that notification in the requested State is effected in accordance with the applicable national laws, regulations and administrative practices. 2. Paragraph 1 is without prejudice to any other form of notification made by a competent authority of the applicant State in accordance with the rules in force in that State. A competent authority established in the applicant State may notify any document directly by registered mail or electronically to a person within the territory of another State. CHAPTER THREE RECOVERY OR PRECAUTIONARY MEASURES Article PVAT.25 Request for recovery 1. At the request of the applicant authority, the requested authority shall recover claims which are the subject of an instrument permitting enforcement in the State of the applicant authority. 2. As soon as any relevant information relating to the matter which gave rise to the request for recovery comes to the knowledge of the applicant authority, it shall forward it to the requested authority. Article PVAT.26 Conditions governing a request for recovery 1. The applicant authority may not make a request for recovery if and as long as the claim or the instrument permitting its enforcement are contested in the State of the applicant authority, except in cases where the third subparagraph of Article PVAT.29(4) applies. 2. Before the applicant authority makes a request for recovery, appropriate recovery procedures available in the State of the applicant authority shall be applied, except in the following situations: (a) where it is obvious that there are no assets for recovery in that State or that such procedures will not result in the payment of a substantial amount, and the applicant authority has specific information indicating that the person concerned has assets in the State of the requested authority; (b) where recourse to such procedures in the State of the applicant authority would give rise to disproportionate difficulty. Article PVAT.27 Instrument permitting enforcement in the State of the requested authority and other accompanying documents 1. Any request for recovery shall be accompanied by a uniform instrument permitting enforcement in the State of the requested authority. This uniform instrument permitting enforcement shall reflect the substantial contents of the initial instrument permitting enforcement in the State of the applicant authority, and constitute the sole basis for recovery and precautionary measures in the State of the requested authority. No act of recognition, supplementing or replacement shall be required in that State. The uniform instrument permitting enforcement shall contain at least the following information: (a) information relevant to the identification of the initial instrument permitting enforcement, a description of the claim, including its nature, the period covered by the claim, any dates of relevance to the enforcement process, and the amount of the claim and its different components such as principal, interest accrued, etc.; (b) name and other data relevant to the identification of the debtor; and (c) name, address and other contact details regarding: (i) the office responsible for the assessment of the claim; and (ii) if different, the office where further information can be obtained concerning the claim or the possibilities for contesting the payment obligation. 2. The request for recovery of a claim may be accompanied by other documents relating to the claim issued by the State of the applicant authority. Article PVAT.28 Execution of the request for recovery 1. For the purpose of the recovery in the State of the requested authority, any claim in respect of which a request for recovery has been made shall be treated as if it was a claim of that State, except where otherwise provided for in this Protocol. The requested authority shall make use of the powers and procedures provided under the laws, regulations or administrative provisions of that State applying to its claims except where otherwise provided for in this Protocol. The State of the requested authority shall not be obliged to grant to claims whose recovery is requested preferences accorded to similar claims arising in the State of the requested authority, except where otherwise agreed or provided under the law of that State. The State of the requested authority shall recover the claim in its own currency. 2. The requested authority shall inform the applicant authority with due diligence of any action it has taken on the request for recovery. 3. From the date on which the recovery request is received, the requested authority shall charge interest for late payment in accordance with the laws, regulations and administrative provisions applicable to its own claims. 4. The requested authority may, where the applicable laws, regulations or administrative provisions so permit, allow the debtor time to pay or authorise payment by instalment and it may charge interest in that respect. It shall inform the applicant authority of any such decision. 5. Without prejudice to Article PVAT.35(1), the requested authority shall remit to the applicant authority the amounts recovered with respect to the claim and the interest referred to in paragraphs 3 and 4 of this Article. Article PVAT.29 Disputed claims and enforcement measures 1. Disputes concerning the claim, the initial instrument permitting enforcement in the State of the applicant authority or the uniform instrument permitting enforcement in the State of the requested authority and disputes concerning the validity of a notification made by an applicant authority shall fall within the competence of the competent bodies of the State of the applicant authority. If, in the course of the recovery procedure, the claim, the initial instrument permitting enforcement in the State of the applicant authority or the uniform instrument permitting enforcement in the State of the requested authority is contested by an interested party, the requested authority shall inform that party that such an action must be brought by the latter before the competent body of the State of the applicant authority in accordance with the laws in force there. 2. Disputes concerning enforcement measures taken in the State of the requested authority or concerning the validity of a notification made by an authority of the requested State shall be brought before the competent body of that State in accordance with its laws and regulations. 3. Where an action as referred to in paragraph 1 has been brought, the applicant authority shall inform the requested authority thereof and shall indicate the extent to which the claim is not contested. 4. As soon as the requested authority has received the information referred to in paragraph 3, either from the applicant authority or from the interested party, it shall suspend the enforcement procedure, as far as the contested part of the claim is concerned, pending the decision of the body competent in the matter, unless the applicant authority requests otherwise in accordance with the third subparagraph of this paragraph. At the request of the applicant authority, or where otherwise deemed to be necessary by the requested authority, and without prejudice to Article PVAT.31, the requested authority may take precautionary measures to guarantee recovery in so far as the applicable laws or regulations allow. The applicant authority may, in accordance with the laws, regulations and administrative practices in force in its State, ask the requested authority to recover a contested claim or the contested part of a claim, in so far as the laws, regulations and administrative practices in force in the State of the requested authority allow. Any such request shall be reasoned. If the result of contestation is subsequently favourable to the debtor, the applicant authority shall be liable for reimbursing any sums recovered, together with any compensation due, in accordance with the laws in force in the State of the requested authority. If a mutual agreement procedure has been initiated between the State of the applicant authority and the State of requested authority, and the outcome of the procedure may affect the claim in respect of which assistance has been requested, the recovery measures shall be suspended or stopped until that procedure has been terminated, unless it concerns a case of immediate urgency because of fraud or insolvency. If the recovery measures are suspended or stopped, the second subparagraph shall apply. Article PVAT.30 Amendment or withdrawal of the request for recovery assistance 1. The applicant authority shall inform the requested authority immediately of any subsequent amendment to its request for recovery or of the withdrawal of its request, indicating the reasons for amendment or withdrawal. 2. If the amendment of the request is caused by a decision of the competent body referred to in Article PVAT.29(1), the applicant authority shall communicate this decision together with a revised uniform instrument permitting enforcement in the State of the requested authority. The requested authority shall then proceed with further recovery measures on the basis of the revised instrument. Recovery or precautionary measures already taken on the basis of the original uniform instrument permitting enforcement in the State of the requested authority may be continued on the basis of the revised instrument, unless the amendment of the request is due to invalidity of the initial instrument permitting enforcement in the State of the applicant authority or the original uniform instrument permitting enforcement in the State of the requested authority. Articles PVAT.27 and PVAT.29 shall apply in relation to the revised instrument. Article PVAT.31 Request for precautionary measures 1. At the request of the applicant authority, the requested authority shall take precautionary measures, if allowed by its national law and in accordance with its administrative practices, to ensure recovery where a claim or the instrument permitting enforcement in the State of the applicant authority is contested at the time when the request is made, or where the claim is not yet the subject of an instrument permitting enforcement in the State of the applicant authority, in so far as precautionary measures are possible in a similar situation under the law and administrative practices of the State of the applicant authority. The document drawn up for permitting precautionary measures in the State of the applicant authority and relating to the claim for which mutual assistance is requested, if any, shall be attached to the request for precautionary measures in the State of the requested authority. This document shall not be subject to any act of recognition, supplementing or replacement in the State of the requested authority. 2. The request for precautionary measures may be accompanied by other documents relating to the claim. Article PVAT.32 Rules governing the request for precautionary measures In order to give effect to Article PVAT.31, Article PVAT.25(2), Article PVAT.28(1) and (2), Article PVAT.29 and Article PVAT.30 shall apply mutatis mutandis to requests under Article PVAT.31. Article PVAT.33 Limits to the requested authority's obligation 1. The requested authority shall not be obliged to grant the assistance provided for in Articles PVAT.25 to PVAT.31 if recovery of the claim would, because of the situation of the debtor, create serious economic or social difficulties in the State of the requested authority, in so far as the laws, regulations and administrative practices in force in that State allow such exception for national claims. 2. The requested authority shall not be obliged to grant the assistance provided for in Articles PVAT.25 to PVAT.31 where the costs or administrative burdens for the requested State would be clearly disproportionate to the monetary benefit to be derived by the applicant State. 3. The requested authority shall not be obliged to grant the assistance provided for in Article PVAT.20 and Articles PVAT.22 to PVAT.31 if the initial request for assistance pursuant to Article PVAT.20, PVAT.22, PVAT.23, PVAT.25 or PVAT.31 is made in respect of claims which are more than 5 years old, dating from the due date of the claim in the State of the applicant authority to the date of the initial request for assistance. However, in cases where the claim or the initial instrument permitting enforcement in the State of the applicant authority is contested, the 5-year period shall be deemed to begin from the moment when it is established in the State of the applicant authority that the claim or the instrument permitting enforcement may no longer be contested. Moreover, in cases where a postponement of the payment or payment by instalments arrangement has been granted by the State of the applicant authority, the 5-year period shall be deemed to begin from the moment when the entire extended payment period has come to its end. However, in those cases the requested authority shall not be obliged to grant assistance in respect of claims which are more than 10 years old, dating from the due date of the claim in the State of the applicant authority. 4. A State shall not be obliged to grant assistance if the total amount for which assistance is requested is less than GBP 5 000. 5. The requested authority shall inform the applicant authority of the grounds for refusing a request for assistance. Article PVAT.34 Questions on limitation 1. Questions concerning periods of limitation shall be governed solely by the laws in force in the State of the applicant authority. 2. In relation to the suspension, interruption or prolongation of periods of limitation, any steps taken in the recovery of claims by or on behalf of the requested authority in pursuance of a request for assistance which have the effect of suspending, interrupting or prolonging the period of limitation according to the laws in force in the State of the requested authority shall have the same effect in the State of the applicant authority, on condition that the corresponding effect is provided for under the law of the latter State. If suspension, interruption or prolongation of the period of limitation is not possible under the laws in force in the State of the requested authority, any steps taken in the recovery of claims by or on behalf of the requested authority in pursuance of a request for assistance which, if they had been carried out by or on behalf of the applicant authority in its own State, would have had the effect of suspending, interrupting or prolonging the period of limitation according to the laws of that State shall be deemed to have been taken in the latter State, in so far as that effect is concerned. The first and second subparagraphs shall not affect the right of the State of the applicant authority to take measures which have the effect of suspending, interrupting or prolonging the period of limitation in accordance with the laws in force in that State. 3. The applicant authority and the requested authority shall inform each other of any action which interrupts, suspends or prolongs the limitation period of the claim for which the recovery or precautionary measures were requested, or which may have this effect. Article PVAT.35 Costs 1. In addition to the amounts referred to in Article PVAT.28(5), the requested authority shall seek to recover from the person concerned and retain the costs linked to the recovery that it incurred, in accordance with the laws and regulations of its State. The States shall renounce all claims on each other for the reimbursement of costs arising from any mutual assistance they grant each other pursuant to this Protocol. 2. However, where recovery creates a specific problem, concerns a very large amount in costs or relates to organised crime, the applicant and requested authorities may agree reimbursement arrangements specific to the cases in question. 3. Notwithstanding paragraph 2, the State of the applicant authority shall be liable to the State of the requested authority for any costs and any losses incurred as a result of actions held to be unfounded, as far as either the substance of the claim or the validity of the instrument permitting enforcement and/or precautionary measures issued by the applicant authority are concerned. CHAPTER FOUR GENERAL RULES GOVERNING ALL TYPES OF RECOVERY ASSISTANCE REQUESTS Article PVAT.36 Use of languages 1. All requests for assistance, standard forms for notification and uniform instruments permitting enforcement in the State of the requested authority shall be sent in, or shall be accompanied by a translation into, the official language, or one of the official languages, of the State of the requested authority. The fact that certain parts thereof are written in a language other than the official language, or one of the official languages, of that State, shall not affect their validity or the validity of the procedure, in so far as that other language is one agreed between the States concerned. 2. The documents for which notification is requested pursuant to Article PVAT.23 may be sent to the requested authority in an official language of the State of the applicant authority. 3. Where a request is accompanied by documents other than those referred to in paragraphs 1 and 2, the requested authority may, where necessary, require from the applicant authority a translation of such documents into the official language, or one of the official languages of the State of the requested authority, or into any other language agreed between the States concerned. Article PVAT.37 Statistical data on recovery assistance 1. By 30 June each year, the Parties shall communicate by electronic means to the Specialised Committee the statistical data on the application of this Title. 2. The content and format of the statistical data to be communicated under paragraph 1 shall be determined by the Specialised Committee. Article PVAT.38 Standard forms and means of communication for recovery assistance 1. Requests pursuant to Article PVAT.20(1) for information, requests pursuant to Article PVAT.23(1) for notification, requests pursuant to Article PVAT.25(1) for recovery or requests pursuant to Article PVAT.31(1) for precautionary measures, and communication of statistical data pursuant to Article PVAT.37 shall be sent by electronic means, using a standard form, unless this is impracticable for technical reasons. As far as possible, these forms shall also be used for any further communication with regard to the request. The uniform instrument permitting enforcement in the State of the requested authority, the document permitting precautionary measures in the State of the applicant authority and the other documents referred to in Articles PVAT.27 and PVAT.31 shall also be sent by electronic means, unless this is impracticable for technical reasons. Where appropriate, the standard forms may be accompanied by reports, statements and any other documents, or certified true copies or extracts thereof, which shall also be sent by electronic means, unless this is impracticable for technical reasons. Standard forms and communication by electronic means may also be used for the exchange of information pursuant to Article PVAT.21. 2. Paragraph 1 shall not apply to the information and documentation obtained through the presence of officials in administrative offices in another State or through participation in administrative enquiries in another State, in accordance with Article PVAT.22. 3. If communication is not made by electronic means or with use of standard forms, this shall not affect the validity of the information obtained or of the measures taken in the execution of a request for assistance. 4. The electronic communication network and the standard forms adopted for the implementation of this Protocol may also be used for recovery assistance regarding other claims than the claims referred to in point (b) of Article PVAT.2(1), if such recovery assistance is possible under other bilateral or multilateral legally binding instruments on administrative cooperation between the States. 5. Pending the adoption by the Specialised Committee of the decisions referred to in Article PVAT.39(2), the competent authorities shall make use of the rules set out in the Annex to this Protocol, including the standard forms. 6. The State of the requested authority shall use its official currency for the transfer of the recovered amounts to the State of the applicant authority, unless otherwise agreed between the States concerned. TITLE IV IMPLEMENTATION AND APPLICATION Article PVAT.39 Trade Specialised Committee on Administrative Cooperation in VAT and Recovery of Taxes and Duties 1. The Specialised Committee shall: (a) hold regular consultations; and (b) review the operation and effectiveness of this Protocol at least every 5 years. 2. The Specialised Committee shall adopt decisions or recommendations to: (a) determine the frequency of, the practical arrangements for and the exact categories of information subject to automatic exchange referred to in Article PVAT.11; (b) review the result of the automatic exchange of information for each category established pursuant to point (a) so as to ensure that this type of exchange takes place only where it is the most efficient means for the exchange of information; (c) establish new categories of information to be exchanged pursuant to Article PVAT.11, should the automatic exchange be the most efficient means of cooperation; (d) define the standard forms for the communications pursuant to Articles PVAT.19(1) and PVAT.38(1); (e) review the availability, collection, and processing of statistical data referred to in Articles PVAT.18 and PVAT.37, so as to ensure that the obligations set out in those Articles do not impose a disproportionate administrative burden on the Parties; (f) establish what shall be transmitted via the CCN/CSI network or other means; (g) determine the amount and the modalities of the financial contribution to be made by the United Kingdom to the general budget of the Union in respect of the cost generated by its participation in the European information systems, taking into account the decisions referred to in points (d) and (f); (h) establish implementing rules on the practical arrangements with regard to the organisation of the contacts between the central liaison offices and liaison departments referred to in Article PVAT.4(2) and (3); (i) establish the practical arrangements between the central liaison offices for the implementation of Article PVAT.4(5); (j) establish implementing rules for Title III, including rules on the conversion of the sums to be recovered and the transfer of sums recovered; and (k) establish the procedure for concluding the service level agreement referred to in Article PVAT.5 and also conclude that service level agreement. TITLE V FINAL PROVISIONS Article PVAT.40 Execution of on-going requests 1. Where requests for information and for administrative enquiries sent in accordance with Regulation (EU) No 904/2010 in relation to the transactions covered by Article 99(1) of the Withdrawal Agreement are not yet closed within four years after the end of the transition period, the requested State shall ensure that those requests are executed in accordance with the rules of this Protocol. 2. Where assistance requests relating to taxes and duties within the scope of Article PVAT.2 of this Protocol sent in accordance with Directive 2010/24/EU in relation to the claims referred to in Article 100(1) of the Withdrawal Agreement are not closed within five years after the end of the transition period, the requested State shall ensure that those assistance requests are executed in accordance with the rules of this Protocol. The standard uniform form for notification or the instrument permitting enforcement in the requested State established in accordance with the legislation referred to in this paragraph shall retain its validity for the purposes of such execution. A revised uniform instrument permitting enforcement in the requested State may be established after the end of that five year period in relation to claims for which assistance was requested before that time. Such revised uniform instruments shall refer to the legal basis used for the initial assistance request. Article PVAT.41 Relation to other agreements or arrangements This Protocol shall take precedence over the provisions of any bilateral or multilateral agreements or arrangements on administrative cooperation in the field of VAT, or on recovery assistance relating to the claims covered by this Protocol, which have been concluded between Member States and the United Kingdom, insofar as their provisions are incompatible with those of this Protocol. (1) For greater certainty and in particular for the purposes of this Protocol, it is understood that the term "person" includes any association of persons lacking the legal status of a legal person but recognized under applicable law as having the capacity to perform legal acts. It also includes any other legal arrangement of whatever nature and form, having legal personality or not, which conducts transactions which are subject to VAT or which is liable for the payment of the claims referred to in point (b) of Article PVAT.2(1) of this Protocol. ANNEX TO THE PROTOCOL ON ADMINISTRATIVE COOPERATION AND COMBATING FRAUD IN THE FIELD OF VALUE ADDED TAX AND ON MUTUAL ASSISTANCE FOR THE RECOVERY OF CLAIMS RELATING TO TAXES AND DUTIES SECTION 1 Pending the adoption by the Specialised Committee of the decisions referred to in Article PVAT.39(2) of this Protocol, the following rules and standard forms apply. SECTION 2 ORGANISATION OF CONTACTS 2.1. Until further notice, the central liaison offices having the principal responsibility for the application of Title II of this Protocol are: (a) for the United Kingdom: Her Majesty's Revenue and Customs, UK VAT Central Liaison Office; (b) for the Member States: the central liaison offices designated for administrative cooperation between the Member States in the area of VAT. 2.2. Until further notice, the central liaison offices having the principal responsibility for the application of Title III of this Protocol are: (a) for the United Kingdom: Her Majesty's Revenue and Customs, Debt Management; (b) for the Member States: the central liaison offices designated for recovery assistance between the Member States. SECTION 3 ADMINISTRATIVE COOPERATION AND COMBATING FRAUD IN THE FIELD OF VALUE ADDED TAX 3.1. Communication The communication of information under Title II of this Protocol shall be done, as far as possible, by electronic means and via the Common Communication Network (CCN), between the respective mailboxes of the States for the exchange of information on administrative cooperation or the mailboxes for combating fraud in the field of VAT. 3.2. Standard form For the exchange of information under Title II of this Protocol, the States shall use the following model: Standard form for requests for information, for spontaneous exchange of information and for feedback between EU Member States and the United Kingdom under the Protocol on administrative cooperation and combating fraud in the area of VAT Exchange of information reference: A) BASIC INFORMATION A1 Requesting State: Requested State: Requesting authority: Requested authority: A2 Official dealing with the request/exchange in the requesting authority: Official dealing with the reply to the request/exchange in the requested authority: Name: Name: Email: Email: Telephone: Telephone: Language: Language: A3 Requesting authority national reference: Requested authority national reference: Space reserved for the requesting authority: Space reserved for the requested authority: A4 Date of transmission of the request/exchange: Date of transmission of the reply: A5 No of attachments to the request/exchange: No of attachments to the reply: A6 A7 o General request/exchange ☐ I, requested authority, will not be able to reply within the following deadlines: o Request for information o 3 months o Spontaneous exchange of information o 1 month for information that is already in my possession ☐ Feedback on spontaneous exchange of information is requested Reason for delay: o Anti-fraud request/exchange o Request for information o Missing Trader Fraud - Registration control/Business activity o Spontaneous supply of information ☐ Feedback on spontaneous information is requested ☐ Expected time of reply: ☐ The requested authority of the State authorises the transmission of the information to another State (Article PVAT.6(6) of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties) ☐ Feedback on the reply is requested Pursuant to Article PVAT.6(4) of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties, the State providing the information shall, on the basis of a reasoned request, permit the use of the information received for purposes other than those referred to in Article 2(1) of that Protocol. B) REQUEST FOR GENERAL INFORMATION Requesting authority Requested authority Requested authority (1) B1 VAT identification number (if not, tax identification number) B1 VAT identification number (if not, tax identification number) o Please fill in o Please confirm o I confirm o I do not confirm VAT number: VAT number: VAT number: ☐ VAT number not available ☐ VAT number not available ☐ VAT number not available Tax identification number: Tax identification number: Tax identification number: B2 Name B2 Name o Please fill in o Please confirm o I confirm o I do not confirm Name: B3 Trading name B3 Trading name o Please fill in o Please confirm o I confirm o I do not confirm Trading name: B4 Address B4 Address o Please fill in o Please confirm o I confirm o I do not confirm Address: B5 The following dates in the format (YYYY/MM/DD): B5 The following dates in the format (YYYY/MM/DD): o Please fill in o Please confirm o I confirm o I do not confirm (a) issue of the VAT/tax identification number (a) issue of the VAT/tax identification number (a) issue of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (c) Incorporation (c) Incorporation (c) Incorporation B6 Date of commencement of activity B6 Date of commencement of activity o Please fill in o Please confirm o I confirm o I do not confirm Date of commencement of activity Date of commencement of activity B7 Date of cessation of activity B7 Date of cessation of activity o Please fill in o Please confirm o I confirm o I do not confirm Date of cessation of activity Date of cessation of activity B8 Names of the managers/directors B8 Names of the managers/directors o Please fill in o Please confirm o I confirm o I do not confirm B9 Names of the owners, proprietors, associates, partners, agents, stakeholders or persons having other rights in the business B9 Names of the owners, proprietors, associates, partners, agents, stakeholders or persons having other rights in the business o Please fill in o Please confirm o I confirm o I do not confirm B10 Nature of the activity B10 Nature of the activity o Please fill in o Please confirm o I confirm o I do not confirm (a) Legal status of the business (a) Legal status of the business (a) Legal status of the business (b) Actual principal activity (2) (b) Actual principal activity (b) Actual principal activity B11 Nature of the transaction Nature of the transaction B11 Goods/services involved o Please fill in Nature of the transaction B11 Goods/services involved o Please confirm o I confirm o I do not confirm Period and amount to which the request/exchange relates B12 Supply of goods from one country to another From Period Period To Amount Amount Sources: ☐ VAT information exchange system (VIES) ☐ Other B13 Supply of services from one country to another From Period Period To Amount Amount Sources: ☐ VIES ☐ Other C) ADDITIONAL INFORMATION Registration ☐ C1 The taxable person in the requested State (☐)/ the taxable person in the requesting State (☐) is currently not identified for VAT purposes. According to the VIES or other sources, supplies have been made after the date of cessation of the activity. Please explain. ☐ C2 The taxable person in the requested State (☐) / the taxable person in the requesting State (☐) is not identified for VAT purposes. According to the VIES or other sources, supplies have been made before the date of registration. Please explain. Transactions of goods/services Goods ☐ C3 According to the VIES or other sources, the taxable person in the requested State made supplies of goods but the taxable person in the requesting State either: o did not declare a purchase of the goods; o denies receipt of the goods; o declared a purchase for a different amount and the declared amount is: Please investigate and explain. ☐ I attach copies of documents in my possession. ☐ C4 The purchase declared by the taxable person in the requesting State does not correspond with the information from VIES or other sources. Please investigate and explain. ☐ C5 Please provide the addresses where the goods were delivered. Addresses: ☐ C6 The taxable person in the requesting State claims to have made supply to a person in the requested State. Please confirm that the goods were received and whether they were: ☐ accounted for: o Yes o No ☐ declared/paid by a taxable person in the requested State o Yes o No Name and/or VAT identification number of the taxable person in the requested State. Prior/onward movement of the goods ☐ C7 From whom were the goods purchased? Please provide names, trading names and VAT numbers in box C41. ☐ C8 To whom were the goods sold on? Please provide names, trading names and VAT numbers in box C41. Services ☐ C9 According to the VIES or other sources, the taxable person in the requested State made supplies of services taxable in the requesting State but the taxable person in the requesting State either: o did not declare the service; o denies having received the service; o declared having receiving the service for a different amount and the declared amount is: Please investigate and explain. ☐ I attach copies of documents in my possession. ☐ C10 The a purchase declared by the taxable person in the requesting State do not correspond with the information from the VIES or other sources. Please investigate and explain. ☐ C11 Please provide the addresses where the services were provided. Addresses: ☐ C12 The taxable person in the requesting State claims to have made supply to a person in the requested State. Please confirm that the services were provided and whether they were: ☐ accounted for: o Yes o No ☐ declared/paid by a taxable person in the requested State o Yes o No Name and/or VAT identification number of the taxable person in the requested State. Transport of goods ☐ C13 Please provide the name/VAT identification number and the address of the transporter. Name and/or VAT identification number and address: ☐ C14 Who ordered and paid the transportation of the goods? Name and/or VAT identification number and address: ☐ C15 Who is the owner of the means of transport used? Name and/or VAT identification number and address: Invoices ☐ C16 Please provide the amount invoiced and currency. Payment ☐ C17 Please provide the amount paid and currency. ☐ C18 Please provide the name of the bank account holder and the number of the account from which and/or to which the payment was made. From: Name of the account holder: IBAN number or account number: Bank: To: Name of the account holder: IBAN number or account number: Bank: ☐ C19 Please provide the following details where the payment was made in cash: ☐ Who handed over the money, to whom, where and when? ☐ What document (cash receipt, etc.) was issued confirming the payment? ☐ C20 Is there any evidence of third party payments? If yes, please provide additional information in box C41 o Yes o No Placing of an order ☐ C21 Please furnish all available details of the person placing the order, how the order was placed and how the contact was established between the supplier and the customer. Goods covered by special schemes/particular procedures Please tick the appropriate box and enter your question in box C40 ☐ C22 Triangular transactions. ☐ C23 Margin scheme. ☐ C24 Distance sales of goods ☐ covered by the Union scheme ☐ covered by the Import scheme ☐ C25 New means of transport sold to non-taxable persons. ☐ C26 Exemption under Customs Procedure 42XX / 63XX. ☐ C27 Gas and electricity. ☐ C28 Call-off stock arrangements. ☐ C29 Others: Services covered by particular provisions Please tick the appropriate box and enter your question in box C40 ☐ C30 Supply of services provided by an intermediary. ☐ C31 Supply of services connected to immovable property. ☐ C32 Supplies of passenger transport. ☐ C33 Supplies of transport of goods. ☐ C34 Supply of cultural, artistic, sporting, scientific, educational, entertainment and similar services, ancillary transport services and valuations of and work on movable tangible property. ☐ C35 Supply of restaurant and catering services other than as provided for at C37. ☐ C36 Supply of transport hire. ☐ C37 Supply of restaurant and catering services for consumption on board of ships, aircraft or trains. ☐ C38 Supply of services ☐ covered by the non-Union scheme ☐ covered by the Union scheme ☐ C39 Services for which effective use and enjoyment rules are applied. ☐ C40 Background information and further questions C41 Free text reply box D) REQUEST FOR DOCUMENTS Please provide copies of the following documents (where applicable see amount and period in part B12 and B13) ☐ D1 Invoices o Provided o Not available ☐ D2 Contracts o Provided o Not available ☐ D3 Orders o Provided o Not available ☐ D4 Evidence of payments o Provided o Not available ☐ D5 Transport documentation o Provided o Not available ☐ D6 Creditor's ledger for the taxable person in the requested State o Provided o Not available ☐ D7 Debtor's ledger for the taxable person in the requested State o Provided o Not available ☐ D8 Call-off stock registers From To o Provided o Not available ☐ D9 One-stop-shop/import one-stop-shop records From To o Provided o Not available ☐ D10 Bank account statements From To o Provided o Not available ☐ D11 Others o Provided o Not available E) SPONTANEOUS SUPPLY OF INFORMATION (GENERAL) ☐ E1 Based on the records of the taxable person in the sending State, it appears that they should be registered in the receiving State. ☐ E2 According to the records of the taxable person in the sending State, ☐ goods / ☐ services were supplied to them by a taxable person in the receiving State, but no information is available via the VIES/Customs or other sources data. ☐ E3 According to the records of the taxable person in the sending State, VAT is to be paid on goods supplied to the receiving State, but no data was entered into VIES/Customs or other sources data. ☐ E4 According to the VIES/Customs or other sources data, the taxable person in the receiving State made supplies to a taxable person in the sending State but the latter taxable person either: ☐ did not declare a purchase of ☐ goods / receipt of ☐ services; ☐ denies the purchase of the ☐ goods / receipt of ☐ services. ☐ E5 According to the records of the taxable person in the sending State, VAT is to be paid on services supplied in the receiving State. ☐ E6 Background and additional information: ☐ E7 I attach copies of invoices in my possession. F) MISSING TRADER FRAUD: REGISTRATION CONTROL / BUSINESS ACTIVITY (A) Identification of the business Requesting authority Requested authority Requested authority (3) F1 VAT identification number (if not, tax identification number) F1 VAT identification number (if not, tax identification number) o Please fill in o Please confirm o I confirm o I do not confirm VAT number: VAT number: VAT number: ☐ VAT number not available ☐ VAT number not available ☐ VAT number not available Tax identification number: Tax identification number: Tax identification number: F2 Name F2 Name o Please fill in o Please confirm o I confirm o I do not confirm Name: F3 Address F3 Address o Please fill in o Please confirm o I confirm o I do not confirm Address: F4 The following dates in the format (YYYY/MM/DD): F4 The following dates in the format (YYYY/MM/DD): o Please fill in o Please confirm o I confirm o I do not confirm (a) issue of the VAT/tax identification number (a) issue of the VAT/tax identification number (a) issue of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (c) Incorporation (c) Incorporation (c) Incorporation F5 Owners, proprietors, associates, partners, agents, stakeholders or persons having other rights in the business F5 Owners, proprietors, associates, partners, agents, stakeholders or persons having other rights in the business o Please fill in o Please confirm o I confirm o I do not confirm (a) Name (a) Name (a) Name (b) Address (b) Address (b) Address (c) Date of birth (c) Date of birth (c) Date of birth (d) Nationality (d) Nationality (d) Nationality F6 Managers/directors F6 Managers/directors o Please fill in o Please confirm o I confirm o I do not confirm (a) Name (a) Name (a) Name (b) Address (b) Address (b) Address (c) Date of birth (c) Date of birth (c) Date of birth (d) Nationality (d) Nationality (d) Nationality (B) Information requested ☐ F7 Are the persons referred to in F5 and F6 (with date of birth if known) contained in any of your databases? o Yes o No ☐ F8 Do those persons referred to in F5 and F6 have a financial criminal record? ☐ The information cannot be given for legal reasons. o Yes o No ☐ F9 Do those persons referred to in F5 and F6 have a history of involvement in missing trader fraud or other type of fraud? ☐ The information cannot be given for legal reasons. o Yes o No ☐ F10 Are those persons referred to in F5 and F6 either resident at or connected with the address given? o Yes o No ☐ F11 Is the stated address residential/business/temporary accommodation/accountant/other? o Yes o No ☐ F12 What is the business activity? ☐ F13 Is the business's tax compliance suspect? o Yes o No ☐ F14 What is the reason for the cancellation of the VAT number? ☐ F15 Please advise of any associated business (4) including their VAT identification numbers and any views as to their credibility. ☐ F16 Please provide details of known bank accounts of the business in the requested State and any associated businesses. ☐ F17 Please provide information from recapitulative statements or from Customs declarations on the supplies/purchases of goods/services for the year(s): ☐ F18 Please provide information from VAT declarations/about payments for the year(s): ☐ F19 Any additional comments: G) SPONTANEOUS SUPPLY OF INFORMATION (MISSING TRADER FRAUD) Sending authority Receiving authority Identification of the business G1 VAT identification number (if not, tax identification number) Identification of the business G1 VAT identification number (if not, tax identification number) VAT number: VAT number: ☐ VAT number not available ☐ VAT number not available Tax identification number: Tax identification number: G2 Name G2 Name G3 Address G3 Address G4 The following dates in the format (YYYY/MM/DD): G4 The following dates in the format (YYYY/MM/DD): (a) issue of the VAT/tax identification number (a) issue of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (b) cancellation of the VAT/tax identification number (c) Incorporation (c) Incorporation G5 Owners, proprietors, associates, partners, agents, stakeholders or persons having other rights in the business G5 Owners, proprietors, associates, partners, agents, stakeholders or persons having other rights in the business (a) Name (a) Name (b) Address (b) Address (c) Date of birth (c) Date of birth (d) Nationality (d) Nationality G6 Managers, directors G6 Managers, directors (a) Name (a) Name (b) Address (b) Address (c) Date of birth (c) Date of birth (d) Nationality (d) Nationality Any additional comments H) FEEDBACK (5) Results related to the information provided: 1) The information provided: ☐ Resulted in an additional assessment of VAT or of other taxes. Please provide details on the type and amount of tax assessed: Type of tax: Additional assessment: Penalty: ☐ Resulted in VAT registration. ☐ Resulted in VAT deregistration. ☐ Resulted in the cancellation of a VAT number from VIES or from VAT registered taxpayer's database. ☐ Resulted in the correction of VAT declarations. ☐ Led to a desk enquiry. ☐ Led to a new audit procedure or was used as part of an on-going audit. ☐ Led to a fraud investigation. ☐ Resulted in a request for information. ☐ Led to a presence in administrative office or to participation in administrative enquiry. ☐ Led to Multilateral control (MLC). ☐ Resulted in other actions: ☐ Did not result in any substantial action. 2) Other comments: Date of transmission: SECTION 4 RECOVERY ASSISTANCE Article 4.1 Communication A request sent by electronic means for the application of Title III of this Protocol shall be sent between the CCN mailboxes that are set up for the type of tax or duty to which the request relates, unless the central liaison offices of the applicant and requested States agree that one of the mailboxes can be used for requests concerning different types of taxes or duties. However, if a request for notification of documents relates to more than one type of tax or duty, the applicant authority shall send that request to a mailbox set up for at least one of the types of claims mentioned in the documents to be notified. Article 4.2 Implementing rules relating to the uniform instrument permitting enforcement in the requested State 1. The administrative penalties, fines, fees and surcharges and the interest and costs referred to in point (b) of Article PVAT.2(1) of this Protocol which, in accordance with the rules in force in the applicant State, may be due from the date of the initial instrument permitting enforcement until the day before the date on which the recovery request is sent, may be added in the uniform instrument permitting enforcement in the requested State. 2. A single uniform instrument permitting enforcement in the requested State may be issued in respect of several claims and several persons, corresponding to the initial instrument or instruments permitting enforcement in the applicant State. 3. In so far as initial instruments permitting enforcement for several claims in the applicant State have already been replaced by a global instrument permitting enforcement for all those claims in that State, the uniform instrument permitting enforcement in the requested State may be based on the initial instruments permitting enforcement in the applicant State or on that global instrument regrouping those initial instruments in the applicant State. 4. Where the initial instrument referred to in paragraph 2 or the global instrument referred to in paragraph 3 contains several claims, one or more of which have already been collected or recovered, the uniform instrument permitting enforcement in the requested State shall only refer to those claims for which recovery assistance is requested. 5. Where the initial instrument referred to in paragraph 2 or the global instrument referred to in paragraph 3 contains several claims, the applicant authority may list those claims in different uniform instruments permitting enforcement in the requested State, in line with the tax type related division of competences of the respective recovery offices in the requested State. 6. If a request cannot be transmitted by CCN network and is transmitted by post, the uniform instrument permitting enforcement in the requested State shall be signed by a duly authorised official of the applicant authority. Article 4.3 Conversion of the sums to be recovered 1. The applicant authority shall express the amount of the claim to be recovered in the currency of the applicant State and in the currency of the requested State. 2. For requests sent to the United Kingdom, the exchange rate to be used for the purposes of the recovery assistance shall be the exchange rate published by the European Central Bank on the day before the date on which the request is sent. Where there is no such rate available on that date, the exchange rate used shall be the latest exchange rate published by the European Central Bank before the date the request is sent. For requests sent to a Member State, the exchange rate to be used for the purposes of the recovery assistance shall be the exchange rate published by the Bank of England on the day before the date on which the request is sent. Where there is no such rate available on that date, the exchange rate used shall be the latest exchange rate published by the Bank of England before the date the request is sent. 3. In order to convert the amount of the claim resulting from the adjustment referred to in Article PVAT.30(2) of this Protocol into the currency of the State of the requested authority, the applicant authority shall use the exchange rate used in its initial request. Article 4.4 Transfer of recovered amounts 1. The transfer of the recovered amounts shall take place within two months of the date on which recovery was effected, unless otherwise agreed between the States. 2. However, if recovery measures applied by the requested authority are contested for a reason not falling within the responsibility of the applicant State, the requested authority may wait to transfer any sums recovered in relation to the applicant State's claim, until the dispute is settled, if the following conditions are simultaneously fulfilled: (a) the requested authority finds it likely that the outcome of this contestation will be favourable to the party concerned; and (b) the applicant authority has not declared that it will reimburse the sums already transferred if the outcome of that contestation is favourable to the party concerned. 3. If the applicant authority has made a declaration to reimburse in accordance with point (b) of the paragraph 2, it shall return the recovered amounts already transferred by the requested authority within one month of the receipt of the request for reimbursement. Any other compensation due shall, in that case, be borne solely by the requested authority. Article 4.5 Reimbursement of recovered amounts The requested authority shall notify any action taken in the requested State for reimbursement of sums recovered or for compensation in relation to recovery of contested claims to the applicant authority immediately after the requested authority has been informed of such action. The requested authority shall as far as possible involve the applicant authority in the procedures for settling the amount to be reimbursed and the compensation due. Upon receipt of a reasoned request from the requested authority, the applicant authority shall transfer the sums reimbursed and the compensation paid within two months of the receipt of that request. Article 4.6 Standard forms 1. For the uniform notification form accompanying the request for notification, referred to in Article PVAT.23 of this Protocol, the States shall use the form established in accordance with model A. 2. For the uniform instrument permitting enforcement in the requested State, referred to in Article PVAT.27 of this Protocol, accompanying the request for recovery or the request for precautionary measures, or the revised uniform instrument permitting enforcement in the requested State, referred to in Article PVAT.30(2) of this Protocol, the States shall use the form established in accordance with model B. 3. For the request for information referred to in Article PVAT.20 of this Protocol, the States shall use the form established in accordance with model C. 4. For the request for notification referred to in Article PVAT.23 of this Protocol, the States shall use the form established in accordance with model D. 5. For the request for recovery or for precautionary measures referred to in Articles PVAT.25 and PVAT.31 of this Protocol, the States shall use the form established in accordance with model E. 6. Where forms are transmitted by electronic means, their structure and lay-out may be adapted to the requirements and possibilities of the electronic communication system, provided that the set of data and information contained therein is not substantially altered when compared to the models set out below. Model A Uniform notification form providing information about notified document(s) (to be transmitted to the addressee of the notification)( 1 ) This document accompanies document(s) hereby notified by the competent authority of the following State: [name of requested State]. This notification concerns documents of the competent authorities of the following State: [name of applicant State], which asked for notification assistance, in accordance with Article PVAT.23 of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties between the European Union and the United Kingdom. A. ADDRESSEE OF THE NOTIFICATION – Name – Address (known or assumed) – Other data relevant to the identification of the addressee B. PURPOSE OF THE NOTIFICATION This notification is intended: ☐ to inform the addressee about the document(s) to which this document is attached ☐ to interrupt the period of limitation with regard to the claim(s) mentioned in the notified document(s). ☐ to confirm to the addressee, his/her obligation to pay the amounts mentioned under point D. Please note that in case of non-payment, the authorities may take enforcement and/or precautionary measures to ensure the recovery of the claim(s). This may cause extra costs charged to the addressee. You are the addressee of this notification, as you are considered to be: ☐ the principal debtor ☐ a co-debtor ☐ a person other than the (co-)debtor, liable for settlement of the taxes, duties and other measures, or for other claims relating to these taxes, duties and other measures, under the laws in force in the applicant State ☐ a person other than the (co-)debtor, holding assets belonging to, or having debts towards, the (co-)debtor or to any other person liable ☐ a third party which may become affected by enforcement measures concerning other persons (The following information will appear if the addressee of the notification is a person other than the (co-)debtor, holding assets belonging to, or having debts towards, the (co-)debtor or to any other person liable, or a third party which may become affected by enforcement measures concerning other persons: The notified documents concern claims relating to taxes and duties, for which the following person(s) is (are) liable as ☐ the principal debtor: [name and address (known or assumed)] ☐ a co-debtor: [name and address (known or assumed)] ☐ a person other than the (co-)debtor, liable for settlement of the taxes, duties and other measures, or for other claims relating to these taxes, duties and other measures, under the laws in force in the applicant State: [name and address (known or assumed)]). The applicant authority of the applicant State [name of the applicant State] invited the competent authorities of the requested State [name of the requested State] to make this notification before [date]. Please note that this date is not specifically related to any period of limitation. C. OFFICE(S) RESPONSIBLE FOR THE NOTIFIED DOCUMENT(S) Office responsible with regard to the attached document(s): – Name: – Address: – Other contact details: – Language(s) in which this office can be contacted: Further information about ☐ the notified document(s) ☐ and/or the possibility of contesting the obligations can be obtained ☐ at the abovementioned office responsible with regard to the attached document(s), and/or ☐ from the following office: – Name: – Address: – Other contact details: – Language(s) in which this office can be contacted: D. DESCRIPTION OF THE NOTIFIED DOCUMENT(S) Document [number] – Reference number: – Date of establishment: – Nature of the notified document: ☐ Tax assessment ☐ Payment order ☐ Decision following an administrative appeal ☐ Other administrative document: ☐ Judgment or order of: ☐ Other judicial document: – Name of the claim(s) concerned (in the language of the applicant State): – Nature of the claim(s) concerned: – Amount of the claim(s) concerned: ☐ Principal amount: ☐ Administrative penalties and fines: ☐ Interest up to [date]: ☐ Costs up to [date]: ☐ Fees for certificates and similar documents issued in connection with administrative procedures related to the claim mentioned under point [x]: ☐ Total amount for this (these) claim(s): – The amount mentioned under point [x] should be paid: ☐ before: ☐ within [number] days following the date of this notification ☐ without any further delay – This payment should be made to: – Holder of the bank account: – International Bank Account Number (IBAN): – Bank Identification Code (BIC): – Name of the bank: – Reference to be used for the payment: – The addressee can reply to the document(s) that is (are) hereby notified. ☐ Last day for replying: ☐ Time period for replying: – Name and address of the authority to whom a reply can be sent: – Possibility of contesting: ☐ The period to contest the claim or the notified document(s) has already come to its end. ☐ Last day for contesting the claim: ☐ Time period to contest the claim: [number of days] following ☐ the date of this notification. ☐ the establishment of the notified document(s) ☐ another date: – Name and address of the authority where a contestation has to be submitted: Please note that disputes concerning the claim, the instrument permitting enforcement or any other document originating from the authorities of the applicant State [name of applicant State], fall within the competence of the competent bodies of the applicant State [name of applicant State], in accordance with Article PVAT.29 of the above Protocol between the European Union and the United Kingdom. Any such dispute is governed by the procedural and language rules applying in the applicant State [name of applicant State]. ☐ Please note that the recovery may begin before the end of the period within which the claim may be contested. – Other information: ______________ (1) The elements in italics are optional. Model B Uniform instrument permitting enforcement of claims covered by Article PVAT.27 of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties between the European Union and the United Kingdom(1) ☐ UNIFORM INSTRUMENT PERMITTING ENFORCEMENT OF CLAIMS – Date of issue: – Reference number: ☐ REVISED UNIFORM INSTRUMENT PERMITTING ENFORCEMENT OF CLAIMS – Date of issue of the original uniform instrument: – Date of revision: – Reason for the revision: ☐ judgment or order of [name of the Court] of [date] ☐ administrative decision of [date] – Reference number: State where this document is issued: [name of applicant State] Recovery measures taken by the requested State are based on: ☐ a uniform instrument permitting enforcement, in accordance with Article PVAT.27 of the above Protocol. ☐ a revised uniform instrument permitting enforcement, in accordance with Article PVAT.30 of the above Protocol (to take account of the decision of the competent body referred to in Article PVAT.29(1) of that Protocol). This document is the uniform instrument permitting enforcement (including precautionary measures). It concerns the claim(s) mentioned below, which remain(s) unpaid in the applicant State [name of applicant State]. The initial instrument for the enforcement of this/these claim(s) has been notified in so far as required under the national law of the applicant State [name of applicant State]. Disputes concerning the claim(s) fall exclusively within the competence of the competent bodies of the applicant State [name of applicant State], in accordance with Article PVAT.29 of the above Protocol. Any such action shall be brought before them in accordance with the procedural and language rules in force in the applicant State [name of applicant State]. DESCRIPTION OF THE CLAIM(S) AND THE PERSON(S) CONCERNED Identification of the claim(s) [number] 1. Reference: 2. Nature of the claim(s) concerned: 3. Name of the tax/duty concerned: 4. Period or date concerned: 5. Date of establishment of the claim: 6. Date on which enforcement becomes possible: 7. Amount of the claim still due: ☐ principal amount: ☐ administrative penalties and fines: ☐ interest till date before the day the request is sent: ☐ costs till date before the day the request is sent: ☐ total amount of this claim: 8. Date of notification of the initial instrument permitting enforcement in the applicant State: [name of the applicant State]: ☐ Date: ☐ No date available 9. Office responsible for the assessment of the claim: – Name: – Address: – Other contact details: – Language(s) in which this office can be contacted: 10. Further information concerning the claim or the possibilities for contesting the payment obligation can be obtained from: ☐ the office indicated above ☐ the following office responsible for the Uniform instrument permitting enforcement: – Name: – Address: – Other contact details: – Language(s) in which this office can be contacted: Identification of the person(s) concerned in the national instrument(s) permitting enforcement (a) The following person is mentioned in the national instrument(s) permitting enforcement ☐ natural person ☐ other – Name – Address (known or assumed) – Other data relevant to the identification of the addressee ☐ Legal representative – Name – Address (known or assumed) – Other data relevant to the identification of the addressee Cause of liability: ☐ principal debtor ☐ a co-debtor ☐ a person other than the (co-)debtor, liable for settlement of the taxes, duties and other measures, or for other claims relating to these taxes, duties and other measures under the laws in force in the applicant State (b) the following person(s) is (are) also mentioned in the national instrument(s) permitting enforcement: ☐ natural person ☐ other – Name: – Address (known or assumed): – Other data relevant to the identification of the addressee: ☐ Legal representative – Name: – Address (known or assumed): – Other data relevant to the identification of the addressee: Cause of liability: ☐ principal debtor ☐ a co-debtor ☐ a person other than the (co-)debtor, liable for settlement of the taxes, duties and other measures, or for other claims relating to these taxes, duties and other measures under the laws in force in the applicant State Other information Overall total amount of the claim(s) – in the currency of the applicant State: – in the currency of the requested State: _____________ (1) The elements in italics are optional. Model form C – request for information REQUEST FOR INFORMATION Based on Article PVAT.20 of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties between the European Union and the United Kingdom Reference: AA_RA_aaaaaaaaaaa_rrrrrrrrrrrr_20YYMMDD_xxxxxxx_RI Nature of the claim(s): 1. STATE OF THE APPLICANT AUTHORITY A. Applicant authority Country: Name: Telephone: Reference of the file: Name of the official dealing with the request: Language skills B. Office initiating the request Name: Address: Postcode: Town: Telephone: E-mail: Reference of the file: Name of the official dealing with the request: 2. STATE OF THE REQUESTED AUTHORITY A. Requested authority Country: Name: Telephone: Reference of the file: Name of the official dealing with the request: Language skills B. Office handling the request Name: Address: Postcode: Town: Telephone: E-mail: Reference of the file: Name of the official dealing with the request: 3. INFORMATION RELATING TO THE REQUEST ☐ I, applicant authority, ask the requested authority not to inform the person(s) concerned about this request. ☐ I, applicant authority, confirm that the information to be received will be subject to the secrecy provisions defined in the legal basis quoted above. 4. INFORMATIONRELATING TO THE PERSON CONCERNED A. Information is requested with regard to: ☐ For natural persons: First name(s): Surname: Maiden name (name at birth): Date of birth: Place of birth: VAT number: Tax Identification Number: Other identification data: Address of this person: ☐ known — ☐ assumed — Street and number: — Details of address: — Postcode and town: — Country: ☐ Or for legal entities: Company name: Legal status: VAT number: Tax Identification Number: Other identification data: Address of this legal entity: ☐ known — ☐ assumed — Street and number: — Details of address: — Postcode and town: — Country: ☐ Legal representative Name: Address of this legal representative: ☐ known — ☐ assumed — Street and number: — Details of address: — Postcode and town: — Country: B. Liability: the person concerned is: ☐ the principal debtor ☐ a co-debtor ☐ a person other than the (co-)debtor, liable for settlement of the taxes, duties and other measures, or for other claims relating to these taxes, duties and other measures under the laws in force in the applicant State; ☐ a person other than the (co-)debtor, holding assets belonging to, or having debts towards, the (co-)debtor or to any other person liable. ☐ a third party which may become affected by enforcement measures concerning other persons. C. Other relevant information concerning the above persons: ☐ Bank account number(s) — Bank account number (IBAN): — Bank identification code (BIC): — Name of the bank: ☐ Car information on 20YY/MM/DD — car plate number: — car brand: — colour of the car: ☐ Estimated or provisional or ☐ precise amount of the claim(s): ☐ Other: 5. INFORMATION REQUESTED ☐ Information about the identity of the person concerned (for natural persons: full name, date and place of birth; for legal entities: company name and legal status) ☐ Information about the address ☐ Information about the income and assets for recovery ☐ Information about the heirs and/or legal successors ☐ Other: 6. FOLLOW-UP OF THE REQUEST FOR INFORMATION Date Nr Message Applicant authority Requested authority date 1 ☐ I, requested authority, acknowledge receipt of the request. date ☐ To be combined with acknowledgment 2 ☐ I, requested authority, invite the applicant authority to complete the request with the following additional information: date 3 ☐ I, requested authority, have not yet received the additional information required and will close your request if I do not receive this information before 20YY/MM/DD. date 4 I, applicant authority, ☐ a provide on request the following additional information: ☐ b am not able to provide the requested additional information (because:) date 5 ☐ I, requested authority, acknowledge receipt of the additional information and am now in a position to proceed. date 6 I, requested authority, do not provide assistance and close the case because: ☐ a I do not have competence for any of the claims to which the request relates. ☐ b the claim is older than foreseen in the Protocol. ☐ c the amount of the claim is below the threshold. ☐ d I am not able to obtain this information for the purpose of recovering similar national claims. ☐ e this would disclose a commercial, industrial or professional secret. ☐ f the disclosure of this information would be liable to prejudice the security or be contrary to the public policy of the State. ☐ g the applicant authority did not provide all the required additional information ☐ h other reason: date 7 ☐ I, applicant authority, ask to be informed about the present status of my request. date 8 I, requested authority, cannot provide the information now because: ☐ I have asked information from other public bodies. ☐ I have asked information from a third party. ☐ I am arranging a personal call. ☐ other reason: date 9 The requested information cannot be obtained because: ☐ a the person concerned is not known. ☐ b insufficient data for identification of person concerned. ☐ c the person concerned has moved away, address unknown. ☐ d the requested information is not available. ☐ e other reason: date 10 ☐ I, requested authority, transmit the following part of the requested information: date 11 I, requested authority, transmit all (or the final part of) the requested information: ☐ a Identity confirmed ☐ b Address confirmed ☐ c The following data about the identity of the person concerned have changed (or are added): For natural persons: ☐ First name(s): ☐ Surname: ☐ Maiden name: ☐ Date of birth: ☐ Place of birth: For legal entities: ☐ Legal Status: ☐ Company name: ☐ d The following address data have changed (or are added): ☐ Street and no.: ☐ Details of address: ☐ Postcode and town: ☐ Country: ☐ Telephone: ☐ Fax: ☐ E-mail: ☐ e Financial situation: ☐ Bank account(s) known: Bank account number (IBAN): … Bank identification code (BIC): … Name of the bank: … ☐ Employment details: ☐ Employee —☐ Self-employed — ☐ Unemployed ☐ It seems that the person concerned has no means to settle the debt/no assets to cover recovery ☐ The person concerned is bankrupt/insolvent: — Date of order: — Date of release: — Liquidators details: Name: Street and no: Details of address: Postcode and town: Country: ☐ It seems that the person concerned has: ☐ limited means to partially settle the debt ☐ sufficient means/assets for recovery ☐ Comments: ☐ f Debt disputed ☐ person concerned has been advised to contest the claim in the State of the applicant authority ☐ references of the dispute, if available: ☐ further details attached ☐ g Debtor deceased on YYYY/MM/DD ☐ h Name and address of heirs/will executor: ☐ i Other comments: ☐ j I recommend proceeding with recovery procedures ☐ k I recommend not proceeding with recovery procedures date 12 ☐ I, applicant authority, withdraw my request for information. date 13 ☐ Other: comment from o applicant authority or o requested authority: Model form D – request for notification REQUEST FOR NOTIFICATION Based on Article PVAT.23 of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties between the European Union and the United Kingdom Reference: AA_RA_aaaaaaaaaaa_rrrrrrrrrrrr_20YYMMDD_xxxxxxx_RN Nature of the claim(s): 1. STATE OF THE APPLICANT AUTHORITY A. Applicant authority Country: Name: Telephone: Reference of the file: Name of the official dealing with the request: Language skills: B. Office initiating the request Name: Address: Postcode: Town: Telephone: E-mail: Reference of the file: Name of the official dealing with the request: 2. STATE OF THE REQUESTED AUTHORITY A. Requested authority Country: Name: Telephone: Reference of the file: Name of the official dealing with the request: Language skills: B. Office handling the request Name: Address: Postcode: Town: Telephone: E-mail: Reference of the file: Name of the official dealing with the request: 3. INFORMATION RELATING TO THE REQUEST ☐ Final date for notification of these documents in order to avoid problems with the limitation period (if necessary): 20YY/MM/DD ☐ Other comments: 4. IDENTIFICATION OF THE ADDRESSEE OF THE NOTIFICATION A. The notification should be made to: ☐ For natural persons: First name(s): Surname: Maiden name (name at birth): Date of birth: Place of birth: VAT number: Tax Identification Number: Other identification data: Address of this person: ☐ known — ☐ assumed: Street and number: Details of address: Postcode and town: Country: ☐ Or for legal entities: Company name: Legal status: VAT number: Tax Identification Number: Other identification data: Address of this legal entity: ☐ known — ☐ assumed Street and number: Details of address: Postcode and town: Country: ☐ Legal representative Name: Address of this legal representative: ☐ known — ☐ assumed Street and number: Details of address: Postcode and town: Country: B. Other relevant information concerning the above persons: 5 PURPOSE OF THE NOTIFICATION: see the attached uniform notification form. 6 DESCRIPTION OF THE NOTIFIED DOCUMENT(S): see the attached uniform notification form. 7. FOLLOW-UP OF THE REQUEST FOR NOTIFICATION Date Nr Message Applicant authority Requested authority date 1 ☐ I, requested authority, acknowledge receipt of the request. date 2 ☐ I, requested authority, invite the applicant authority to complete the request with the following additional information: date 3 ☐ I, requested authority, have not yet received the additional information required and will close your request if I do not receive this information before 20YY/MM/DD. date 4 I, applicant authority, ☐ a provide on request the following additional information: ☐ b I am not able to provide the requested additional information (because: ) date 5 ☐ I, requested authority, acknowledge receipt of the additional information and am now in a position to proceed. date 6 ☐ ☐ ☐ ☐ ☐ I, requested authority, do not provide assistance and close the case because: a I do not have competence for any of the taxes to which the request relates. b the claim(s) is/are older than foreseen in the Protocol. c the amount of the claim(s) is below the threshold. d the applicant authority did not provide all the required additional information e Other reason: date 7 ☐ I, applicant authority, ask to be informed about the present status of my request. date 8 I, requested authority, certify: ☐ a that the document(s) has (have) been notified to the addressee, with legal effect according to the national legislation of the State of the requested authority, on 20YY/MM/DD. The notification was made in the following manner: ☐ to the addressee in person ☐ by mail ☐ by electronic mail ☐ by registered mail ☐ by bailiff ☐ by another procedure ☐ b that the above-mentioned document(s) could not be notified to the person concerned for the following reasons: ☐ addressee(s) not known ☐ addressee(s) deceased ☐ addressee(s) has (have) left the State. New address: ☐ other: date 9 ☐ I, applicant authority, withdraw my request for notification. date 10 ☐ Other: comment from o applicant authority or o requested authority Model form E – request for recovery or precautionary measures REQUEST FOR ☐ RECOVERY MEASURES Based on Article PVAT.25 of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties between the European Union and the United Kingdom AND/OR ☐ PRECAUTIONARY MEASURES Based on Article PVAT.31 of the Protocol on administrative cooperation and combating fraud in the field of Value Added Tax and on mutual assistance for the recovery of claims relating to taxes and duties between the European Union and the United Kingdom Reference: AA_RA_aaaaaaaaaaa_rrrrrrrrrrrr_20YYMMDD_xxxxxxx_RR(RP) Nature of the claim(s): 1. STATE OF THE APPLICANT AUTHORITY A. Applicant authority Country: Name: Telephone: Reference of the file: Name of the official dealing with the request: Language skills: B. Office initiating the request Name: Address: Postcode: Town: Telephone: E-mail: Reference of the file: Name of the official dealing with the request: 2. STATE OF THE REQUESTED AUTHORITY A. Requested authority Country: Name: Telephone: Reference of the file: Name of the official dealing with the request: Language skills: B. Office handling the request Name: Address: Postcode: Town: Telephone: E-mail: Reference of the file: Name of the official dealing with the request: 3. INFORMATION ABOUT THE REQUEST ☐ The claim(s) is (are) the subject of an instrument permitting enforcement in the applicant State. ☐ The claim(s) is (are) not yet subject of an instrument permitting enforcement in the applicant State. ☐ The claim(s) is (are) not contested. ☐ The claim(s) may no longer be contested by an administrative appeal/by an appeal to the courts. ☐ The claim(s) is (are) contested but the laws, regulations and administrative practices in force in the State of the applicant authority allow recovery of a contested claim. ☐ The total amount of the claims for which assistance is requested, is not less than GBP 5 000 . ☐ This request relates to claims that fulfil the age requirement applying under the Protocol. ☐ This request for precautionary measures is based on the reasons described in the attached document(s). ☐ This request is accompanied by an instrument permitting precautionary measures in the applicant state. ☐ I request not to inform the debtor/other person concerned prior to the precautionary measures. ☐ Please contact me if the following specific situation occurs (by using the free text field at the end of the request form: ☐ I, applicant authority will reimburse the sums already transferred if the outcome of the contestation is favourable to the party concerned. ☐ Sensitive case: 4. PAYMENT INSTRUCTIONS A. Please remit the amount of the claim recovered to: — Bank account number (IBAN): — Bank identification code (BIC): — Name of the bank: — Name of the account holder: — Address of the account holder: — Payment reference to be used at the transfer of the money: B. Payment by instalment is: ☐ acceptable without further consultation ☐ only acceptable after consultation (Please use box 7, point 20 for this consultation) ☐ not acceptable 5. INFORMATION ABOUT THE PERSON CONCERNED BY THE REQUEST A Recovery/precautionary measures are requested with regard to: ☐ For natural persons: First name(s): Surname: Maiden name (name at birth): Date of birth: Place of birth: VAT number: Tax Identification Number: Other identification data: Address of this person/legal entity: ☐ known — ☐ assumed Street and number: Details of address: Postcode and town: ☐ Or for legal entities: Legal status: Company name: VAT number: Tax Identification Number: Other identification data: Address of this person/legal entity: ☐ known — ☐ assumed Street and number: Details of address: Postcode and town: — other information concerning this person: — ☐ Legal representative — Name: — Details of address: ☐ known — ☐ assumed — Street and number: — Postcode and town: — Country: B Other relevant information concerning this request and/or person 1 ☐ The following person(s) is (are) co-debtor(s): [It should be possible to add more than 1 name of such persons] — Identity of this person: ☐ For natural persons: — Name: — Date of birth: — VAT number: — Tax Identification Number: — Street and number: — Details of address: — Postcode and town: ☐ Or for legal entities: — Legal status: — Company name: — VAT number: — Tax Identification Number: — Street and number: — Details of address: — Postcode and town: — other information concerning this (these) co-debtor(s): 2 ☐ The following person(s) is (are) holding assets belonging to the person concerned by this request: [It should be possible to add more than 1 name of such persons] — Identity of this person: ☐ For natural persons: — Name: — Date of birth: — VAT number: — Tax Identification Number: — Street and number: — Details of address: — Postcode and town: ☐ Or for legal entities: — Legal status: — Company name: — VAT number: — Tax Identification Number: — Street and number: — Details of address: — Postcode and town: — assets held by this other person: 3 ☐ The following person(s) is (are) having debts towards the person concerned by this request: [It should be possible to add more than 1 name of such persons] — Identity of this person: ☐ For natural persons: — Name: — Date of birth: — VAT number: — Tax Identification Number: — Street and number: — Details of address: — Postcode and town: ☐ Or for legal entities: — Legal status: — Company name: — VAT number — Tax Identification Number: — Street and number: — Details of address: — Postcode and town: — (future) debts of this other person: 4 ☐ There (is) are (an)other person(s) than the person concerned by this request, who (is) are liable for settlement of the taxes, duties and other measures, or for other claims relating to these taxes, duties and other measures under the laws of the applicant State. [It should be possible to add more than 1 name of such persons] — Identity of this person: ☐ For natural persons: — Name: — Date of birth: — VAT number: — Tax Identification Number: — Street and number: — Details of address: — Postcode and town: ☐ Or for legal entities: — Legal status: — Company name: — VAT number: — Tax Identification Number: — Street and number: — Details of address: — Postcode and town: — Reason or nature of the liability of this other person: 6. DESCRIPTION OF THE CLAIM(S): see the attached uniform instrument permitting enforcement in the requested State. 7. FOLLOW-UP OF THE REQUEST Applicant authority Requested authority date 1 ☐ I, requested authority, acknowledge receipt of the request. date ☐ To be combined with acknowledgment 2 ☐ I, requested authority, invite the applicant authority to complete the request with the following additional information: date 3 ☐ I, requested authority, have not yet received the additional information required and will close your request if I do not receive this information before 20YY/MM/DD. date 4 I, applicant authority, ☐ a provide on request the following additional information: ☐ b am not able to provide the requested additional information (because: ) date 5 ☐ I, requested authority, acknowledge receipt of the additional information and am now in a position to proceed. date 6 I, requested authority, do not provide assistance and close the case because: ☐ a I do not have competence for the claims to which your request relates. ☐ b I do not have competence for the following claim(s) of your request: ☐ c the claim(s) is/are older than foreseen in the Protocol. ☐ d the total amount is less than the threshold foreseen in the Protocol. ☐ e the applicant authority did not provide all the required additional information. ☐ f Other reason: date 7 ☐ I, applicant authority, ask to be informed about the present status of my request. date 8 I, requested authority, will not take the requested action(s), for the following reasons: ☐ a my national legislation and practice does not allow recovery measures for claims that are contested. ☐ b my national legislation and practice does not allow precautionary measures for claims that are contested. 9 I, requested authority, have conducted the following procedures for recovery and/or precautionary measures: date ☐ a I established contact with the debtor and requested payment on 20YY/MM/DD. date ☐ b I am negotiating payment by instalment. date ☐ c I have commenced enforcement procedures on 20YY/MM/DD. The following actions have been taken: ☐ d I have commenced precautionary measures on 20YY/MM/DD. The following actions have been taken: ☐ e I, requested authority, inform the applicant authority that the measures which I have taken (described under point c and/or d above) have the following effect on the period of limitation: ☐ suspension ☐ interruption ☐ prolongation ☐ till 20YY/MM/DD – ☐ with xx years/months/weeks/days I ask the applicant State to inform me if the same effect is not provided for under the laws in force in the applicant State. ☐ f I, requested authority, inform the applicant authority that suspension, interruption or prolongation of the period of limitation is not possible under the laws of the requested State. I ask the applicant State to confirm whether the measures which I have taken (described under point c and/or d above) have interrupted, suspended or prolonged the time limit for recovery and, if so, what the new time limit is. date 10 ☐ Procedures are still going on. I, requested authority, will inform applicant authority when changes occur. date 11 ☐ a I, applicant authority, confirm that: as a result of the action mentioned under point 9, the time limit has been changed. The new time limit is: … ☐ b My national laws do not provide for the suspension, interruption or prolongation of the period of limitation. 12 I, requested authority, inform the applicant authority that: date ☐ a the claim has been fully recovered on 20YY/MM/DD — of which the following amount (indicate the currency of the State of the requested authority) relates to the claim as mentioned in the request: — of which the following amount relates to the interest charged under the laws of the State of the requested authority: date ☐ b the claim has been partly recovered on 20YY/MM/DD, — for the amount of (indicate the currency of the State of the requested authority): — of which the following amount relates to the claim as mentioned in the request: — of which the following amount relates to the interest charged under the laws of the State of the requested authority: ☐ I will take no further action. ☐ I will continue recovery procedures. date ☐ c precautionary measures have been taken. (The requested authority is invited to indicate the nature of these measures:) date ☐ d the following payment by instalment has been agreed: date 13 I, requested authority, confirm that all or part of the claim could not be recovered/ precautionary measures will not be taken, and the case will be closed because: ☐ a The person concerned is not known. ☐ b The person concerned is known, but moved to: ☐ c The person concerned is known, but moved to an unknown address. ☐ d The person concerned is deceased on YYYY/MM/DD. ☐ e Debtor/co-debtor is insolvent. ☐ f Debtor/co-debtor is bankrupt and the claim has been lodged. Date of order: … --- Date of release: … ☐ g Debtor/co-debtor is bankrupt / no recovery possible ☐ h Others: date 14 ☐ I, applicant authority, confirm that the case is closed. date 15 ☐ I, requested authority, inform the applicant authority that I have received notification that an action has been launched contesting the claim or the instrument permitting its enforcement and will suspend enforcement procedures. Further, ☐ a I have taken precautionary measures to ensure recovery of the claim on …. ☐ b I ask the applicant authority to inform me whether I should recover the claim. ☐ c I inform the applicant authority that the laws, regulations and administrative practices in force in the State in which I am situated do not permit (continued) recovery of the claim as long as it is contested. date 16 I, applicant authority, having been informed that an action has been launched contesting the claim or the instrument permitting its enforcement, ☐ a ask the requested authority to suspend any action which it has undertaken. ☐ b ask the requested authority to take precautionary measures to ensure recovery of the claim. ☐ c ask the requested authority to (continue to) recover the claim. date 17 ☐ I, requested authority, inform the applicant authority that the laws, regulations and administrative practices in force in the State in which I am situated do not permit the action requested: ☐ under point 16(b). ☐ under point 16(c). date 18 I, applicant authority, ☐ a amend the request for recovery/precautionary measures ☐ in accordance with the decision about the contested claim, [this information about the decision will be put in box 6A] ☐ because part of the claim was paid directly to the applicant authority; ☐ for another reason: …. ☐ b ask the requested authority to resume enforcement procedures since the contestation was not favourable to the debtor (decision of the body competent in this matter of …). date 19 I, applicant authority, withdraw this request for recovery/precautionary measures because: ☐ a the amount was paid directly to the applicant authority. ☐ b the time limit for recovery action has elapsed. ☐ c the claim(s) has (have) been annulled by a national court or by an administrative body. ☐ d the instrument permitting enforcement has been annulled. ☐ e other reason: … date 20 ☐ Other: comment from o applicant authority or o requested authority (Please start each comment by indicating the date) (1) In this third column, the requested authority either fills in the information requested by the requesting authority (box "please fill in" ticked in the second column) or confirms the veracity of the information provided by the requesting authority (box "please confirm" ticked and information provided in the second column). (2) Actual principal activity means the real main activity carried out by the business (as opposed to another possibly declared one). (3) In this third column, the requested authority either fills in the information requested by the requesting authority (box "please fill in" ticked in the second column) or confirms the veracity of the information provided by the requesting authority (box "please confirm" ticked and information provided in the second column). (4) This is any business with common directors or other legal, economic or financial links with the business referred to in Heading A. (5) To be provided by the competent authority receiving the information. PROTOCOL ON MUTUAL ADMINISTRATIVE ASSISTANCE IN CUSTOMS MATTERS Article PCUST.1 Definitions 1. For the purposes of this Protocol: (a) "applicant authority" means a competent administrative authority which has been designated by a Party for this purpose and which makes a request for assistance on the basis of this Protocol; (b) "operations in breach of customs legislation" means any violation or attempted violation of customs legislation; (c) "requested authority" means a competent administrative authority which has been designated by a Party for this purpose and which receives a request for assistance on the basis of this Protocol. 2. Unless otherwise provided in this Protocol, the definitions of Chapter 5 of Title I of Heading One of Part Two of this Agreement also apply to this Protocol. Article PCUST.2 Scope 1. The Parties shall assist each other in the areas within their competence, in the manner and under the conditions laid down in this Protocol, to ensure the correct application of customs legislation, in particular by preventing, investigating and combating operations in breach of that legislation. 2. The provisions on assistance in customs matters provided for in this Protocol apply to any administrative authority of either Party which is competent for the application of this Protocol. That assistance shall neither prejudice the provisions governing mutual assistance in criminal matters nor shall it cover information obtained under powers exercised at the request of a judicial authority, except where communication of such information is authorised by that authority. 3. Assistance in the recovery of duties, taxes or fines is covered by the Protocol on administrative cooperation and combating fraud in the field of value added tax and on mutual assistance for the recovery of claims relating to taxes and duties. Article PCUST.3 Assistance on request 1. At the request of the applicant authority, the requested authority shall provide the applicant authority with all relevant information which may enable the applicant authority to ensure that customs legislation is correctly applied, including information related to activities noted or planned which are or could be operations in breach of customs legislation. 2. At the request of the applicant authority, the requested authority shall in particular inform it whether: (a) goods exported from the territory of one of the Parties have been properly imported into the territory of the other Party, specifying, where appropriate, the customs procedure applied to the goods; (b) goods imported into the territory of one of the Parties have been properly exported from the territory of the other Party, specifying, where appropriate, the customs procedure applied to the goods. 3. At the request of the applicant authority, the requested authority shall take the necessary steps in accordance with its applicable laws and regulations to ensure special surveillance of and to provide the applicant authority with information on: (a) natural or legal persons in respect of whom there are reasonable grounds for believing that they are or have been involved in operations in breach of customs legislation; (b) goods that are or may be transported in such a way that there are reasonable grounds for believing that they have been or are intended to be used in operations in breach of customs legislation; (c) places where stocks of goods have been or may be stored or assembled in such a way that there are reasonable grounds for believing that these goods have been or are intended to be used in operations in breach of customs legislation; (d) means of transport that are or may be used in such a way that there are reasonable grounds for believing that they are intended to be used in operations in breach of customs legislation; and (e) premises suspected by the applicant authority of being used to commit breaches of customs legislation. Article PCUST.4 Spontaneous assistance Wherever possible, on their own initiative, the Parties shall assist each other in accordance with their laws and regulations by providing information on concluded, planned or ongoing activities which constitute or appear to constitute operations in breach of customs legislation and which may be of interest to the other Party. The information shall focus in particular on: (a) goods known to be subject to operations in breach of customs legislation; (b) persons in respect of whom there are reasonable grounds for believing they are or have been involved in operations in breach of customs legislation; (c) means of transport in respect of which there are reasonable grounds for believing that they have been, are, or may be used in operations in breach of customs legislation; and (d) new means or methods employed in carrying out operations in breach of customs legislation. Article PCUST.5 Form and substance of requests for assistance 1. Requests pursuant to this Protocol shall be made in writing either in print or electronic format. They shall be accompanied by the documents necessary to enable compliance with the request. In case of urgency, the requested authority may accept oral requests, but such oral requests shall be confirmed by the applicant authority in writing promptly. 2. Requests pursuant to paragraph 1 shall include the following information: (a) the applicant authority and requesting official; (b) the information or type of assistance requested; (c) the object of and the reason for the request; (d) the laws and regulations and other legal elements involved; (e) indications as exact and comprehensive as possible on the goods or persons who are the target of the investigations; (f) a summary of the relevant facts and of the enquiries already carried out; and (g) any additional available details to enable the requested authority to comply with the request. 3. Requests shall be submitted in an official language of the requested authority or in a language acceptable to that authority, English always being an acceptable language. This requirement does not apply to any documents that accompany the request under paragraph 1. 4. If a request does not meet the formal requirements set out in this Article, the requested authority may require the correction or the completion of the request; pending such correction or completion, precautionary measures may be ordered. Article PCUST.6 Execution of requests 1. In order to comply with a request for assistance, the requested authority shall proceed promptly, within the limits of its competence, as though it was acting on its own account or at the request of another authority of that same Party, by supplying information already in its possession, by carrying out appropriate enquiries or by arranging for those enquiries to be carried out. This provision shall also apply to any other authority to which the request has been addressed by the requested authority when the latter cannot act on its own. In providing any such assistance the requested authority shall give appropriate consideration to the urgency of the request. 2. Requests for assistance shall be executed in accordance with the laws and regulations of the requested Party. Article PCUST.7 Form in which information is to be communicated 1. The requested authority shall communicate results of enquiries conducted pursuant to a request made under this Protocol to the applicant authority in writing, together with relevant documents, certified copies of documents or other items. This information may be provided in electronic format. 2. Original documents shall be transmitted according to each Party's legal constraints, only at the request of the applicant authority, in cases where certified copies would be insufficient. The applicant authority shall return those originals at the earliest opportunity. 3. Under the provisions referred to in paragraph 2, the requested authority shall deliver to the applicant authority any information related to the authenticity of the documents issued or certified by official agencies within its territory in support of a goods declaration. Article PCUST.8 Presence of officials of one Party in the territory of another 1. Duly authorised officials of a Party may, with the agreement of the other Party and subject to the conditions laid down by the latter, be present in the offices of the requested authority or any other concerned authority referred to in Article PCUST.6(1) to obtain information relating to activities that are or could be operations in breach of customs legislation which the applicant authority needs for the purposes of this Protocol. 2. With the agreement of the requested Party, and subject to the conditions it may specify, duly authorised officials of the other Party may be present at enquiries carried out in the requested Party's territory. Article PCUST.9 Delivery and notification 1. At the request of the applicant authority, the requested authority shall take all necessary measures in accordance with its applicable laws and regulations in order to deliver any documents or to notify any decisions of the applicant authority that fall within the scope of this Protocol, to an addressee residing or established in the territory of the requested authority. 2. Such requests for the delivery of documents or the notification of decisions shall be made in writing in an official language of the requested authority or in a language acceptable to that authority. Article PCUST.10 Automatic exchange of information 1. The Parties may, by mutual arrangement in accordance with Article PCUST.15 of this Protocol: (a) exchange any information covered by this Protocol on an automatic basis; (b) exchange specific information in advance of the arrival of consignments in the territory of the other Party. 2. The Parties may establish arrangements on the type of information they wish to exchange, the format and the frequency of transmission to implement the exchanges under points (a) and (b) of paragraph 1. Article PCUST.11 Exceptions to the obligation to provide assistance 1. Assistance under this Protocol may be refused or may be subject to the satisfaction of certain conditions or requirements in cases where a Party is of the opinion that such assistance would: (a) be likely to prejudice the sovereignty of the United Kingdom or that of a Member State which has been requested to provide assistance under this Protocol; (b) be likely to prejudice public policy, security or other essential interests; or (c) violate an industrial, commercial or professional secret. 2. The requested authority may postpone the assistance on the grounds that such assistance will interfere with ongoing investigations, prosecutions or proceedings. In such a case, the requested authority shall consult with the applicant authority to determine if assistance can be given subject to such terms or conditions as the requested authority may require. 3. Where the applicant authority seeks assistance which it would itself be unable to provide if so requested, it shall draw attention to that fact in its request. It shall then be for the requested authority to decide how to respond to such a request. 4. In the cases referred to in paragraphs 1 and 2, the requested authority shall communicate its decision and the reasons for that decision to the applicant authority without delay. Article PCUST.12 Information exchange and confidentiality 1. The information received under this Protocol shall be used solely for the purposes established in this Protocol. 2. The use of information obtained under this Protocol in administrative or judicial proceedings instituted in respect of operations in breach of customs legislation is considered to be for the purposes of this Protocol. Therefore, the Parties may use information obtained and documents consulted in accordance with the provisions of this Protocol as evidence in their records of evidence, reports and testimonies and in proceedings and charges brought before the courts or tribunals. The requested authority may subject the supply of information or the granting of access to documents to the condition that it is notified of such use. 3. Where one of the Parties wishes to use such information for other purposes, it shall obtain the prior written consent of the authority which provided the information. Such use shall then be subject to any restrictions laid down by that authority. 4. Any information communicated in whatsoever form pursuant to this Protocol shall be considered to be of a confidential or restricted nature, in accordance with the laws and regulations applicable in each Party. That information shall be covered by the obligation of professional secrecy and shall enjoy the protection granted to similar information under the relevant laws and regulations of the receiving Party, unless the Party which provided the information gives its prior consent to the disclosure of such information. The Parties shall communicate to each other information on their applicable laws and regulations. Article PCUST.13 Experts and witnesses The requested authority may authorise its officials to appear, within the limitations of the authorisation granted, as experts or witnesses in judicial or administrative proceedings regarding the matters covered by this Protocol, and produce such objects, documents or confidential or certified copies thereof, as may be needed for the proceedings. The request for appearance must indicate specifically before which judicial or administrative authority the official will have to appear, on what matters and by virtue of what title or qualification the official will be questioned. Article PCUST.14 Assistance expenses 1. Subject to paragraphs 2 and 3, the Parties shall waive any claims on each other for reimbursements of expenses incurred in the execution of this Protocol. 2. Expenses and allowances paid to experts, witnesses, interpreters and translators, other than public service employees, shall be borne as appropriate by the requesting Party. 3. If expenses of a substantial or extraordinary nature are or will be required to execute the request, the Parties shall consult to determine the terms and conditions under which the request is to be executed, as well as the manner in which the costs are to be borne. Article PCUST.15 Implementation 1. The implementation of this Protocol shall be entrusted on the one hand to the customs authorities of the United Kingdom and on the other hand to the competent services of the European Commission and the customs authorities of the Member States of the Union, as appropriate. They shall decide on all practical measures and arrangements necessary for the implementation of this Protocol, taking into consideration their respective applicable laws and regulations, in particular for the protection of personal data. 2. Each Party shall keep the other Party informed of the detailed implementation measures which it adopts in accordance with the provisions of this Protocol, in particular with respect to the duly authorised services and officials designated as competent to send and receive the communications provided for in this Protocol. 3. In the Union, the provisions of this Protocol shall not affect the communication of any information obtained under this Protocol between the competent services of the European Commission and the customs authorities of the Member States. Article PCUST.16 Other agreements The provisions of this Protocol shall take precedence over the provisions of any bilateral agreement on mutual administrative assistance in customs matters which has been or may be concluded between individual Member States of the Union and the United Kingdom insofar as the provisions of those bilateral agreements are incompatible with those of this Protocol. Article PCUST.17 Consultations In respect of the interpretation and implementation of this Protocol, the Parties shall consult each other to resolve the matter in the framework of the Trade Specialised Committee on Customs Cooperation and Rules of Origin. Article PCUST.18 Future developments With a view to supplementing the levels of mutual assistance provided for in this Protocol, the Trade Specialised Committee on customs cooperation and rules of origin may adopt a decision to expand this Protocol by establishing arrangements on specific sectors or matters in accordance with the Parties' respective customs legislation. PROTOCOL ON SOCIAL SECURITY COORDINATION TITLE I GENERAL PROVISIONS Article SSC.1 Definitions For the purposes of this Protocol, the following definitions apply: (a) "activity as an employed person" means any activity or equivalent situation treated as such for the purposes of the social security legislation of the State in which such activity or equivalent situation exists; (b) "activity as a self-employed person" means any activity or equivalent situation treated as such for the purposes of the social security legislation of the State in which such activity or equivalent situation exists; (c) "assisted reproduction services" means any medical, surgical or obstetric services provided for the purpose of assisting a person to carry a child; (d) "benefits in kind" means: (i) for the purposes of Chapter 1 of Title III, benefits in kind provided for under the legislation of a State which are intended to supply, make available, pay directly or reimburse the cost of medical care and products and services ancillary to that care; (ii) for the purposes of Chapter 2 of Title III, all benefits in kind relating to accidents at work and occupational diseases as defined in point (i) and provided for under the States' accidents at work and occupational diseases schemes; (e) "child-raising period" refers to any period which is credited under the pension legislation of a State or which provides a supplement to a pension explicitly for the reason that a person has raised a child, irrespective of the method used to calculate those periods and whether they accrue during the time of child-raising or are acknowledged retroactively; (f) "civil servant" means a person considered to be such or treated as such by the State to which the administration employing them is subject; (g) "competent authority" means, in respect of each State, the Minister, Ministers or other equivalent authority responsible for social security schemes throughout or in any part of the State in question; (h) "competent institution" means: (i) the institution with which the person concerned is insured at the time of the application for benefit; or (ii) the institution from which the person concerned is or would be entitled to benefits if that person or a member or members of their family resided in the State in which the institution is situated; or (iii) the institution designated by the competent authority of the State concerned; or (iv) in the case of a scheme relating to an employer's obligations in respect of the benefits set out in Article SSC.3(1), either the employer or the insurer involved or, in default thereof, the body or authority designated by the competent authority of the State concerned; (i) "competent State" means the State in which the competent institution is situated; (j) "death grant" means any one-off payment in the event of death, excluding the lump-sum benefits referred to in point (w); (k) "family benefit" means all benefits in kind or in cash intended to meet family expenses; (l) "frontier worker" means any person pursuing an activity as an employed or self-employed person in a State and who resides in another State to which that person returns as a rule daily or at least once a week; (m) "home base" means the place from where the crew member normally starts and ends a duty period or a series of duty periods, and where, under normal conditions, the operator/airline is not responsible for the accommodation of the crew member concerned; (n) "institution" means, in respect of each State, the body or authority responsible for applying all or part of the legislation; (o) "institution of the place of residence" and "institution of the place of stay" mean, respectively, the institution which is competent to provide benefits in the place where the person concerned resides and the institution which is competent to provide benefits in the place where the person concerned is staying, in accordance with the legislation administered by that institution or, where no such institution exists, the institution designated by the competent authority of the State concerned; (p) "insured person", in relation to the social security branches covered by Chapters 1 and 3 of Title III, means any person satisfying the conditions required under the legislation of the State competent under Title II in order to have the right to benefits, taking into account the provisions of this Protocol; (q) "legislation" means, in respect of each State, laws, regulations and other statutory provisions and all other implementing measures relating to the social security branches covered by Article SSC.3(1), but excludes contractual provisions other than those which serve to implement an insurance obligation arising from the laws and regulations referred to in this point or which have been the subject of a decision by the public authorities which makes them obligatory or extends their scope, provided that the State concerned makes a declaration to that effect, notified to the Specialised Committee on Social Security Coordination. The European Union shall publish such a declaration in the Official Journal of the European Union; (r) "long-term care benefit" means a benefit in kind or in cash the purpose of which is to address the care needs of a person who, on account of impairment, requires considerable assistance, including but not limited to assistance from another person or persons to carry out essential activities of daily living for an extended period of time in order to support their personal autonomy; this includes benefits granted for the same purpose to a person providing such assistance; (s) "member of the family" means: (i) (A) any person defined or recognised as a member of the family or designated as a member of the household by the legislation under which benefits are provided; (B) with regard to benefits in kind pursuant to Chapter 1 of Title III, any person defined or recognised as a member of the family or designated as a member of the household by the legislation of the State in which that person resides; (ii) if the legislation of a State which is applicable under point (i) does not make a distinction between the members of the family and other persons to whom it is applicable, the spouse, minor children, and dependent children who have reached the age of majority shall be considered members of the family; (iii) if, under the legislation which is applicable under points (i) and (ii), a person is considered a member of the family or member of the household only if that person lives in the same household as the insured person or pensioner, this condition shall be considered satisfied if the person in question is mainly dependent on the insured person or pensioner; (t) "period of employment" or "period of self-employment" mean periods so defined or recognised by the legislation under which they were completed, and all periods treated as such, where they are regarded by that legislation as equivalent to periods of employment or to periods of self-employment; (u) "period of insurance" means periods of contribution, employment or self-employment as defined or recognised as periods of insurance by the legislation under which they were completed or considered as completed, and all periods treated as such, where they are regarded by that legislation as equivalent to periods of insurance; (v) "period of residence" means periods so defined or recognised by the legislation under which they were completed or considered as completed; (w) "pension" covers not only pensions but also lump-sum benefits which can be substituted for them and payments in the form of reimbursement of contributions and, subject to the provisions of Title III, revaluation increases or supplementary allowances; (x) "pre-retirement benefit" means all cash benefits, other than an unemployment benefit or an early old-age benefit, provided from a specified age to workers who have reduced, ceased or suspended their remunerative activities until the age at which they qualify for an old-age pension or an early retirement pension, the receipt of which is not conditional upon the person concerned being available to the employment services of the competent State; "early old-age benefit" means a benefit provided before the normal pension entitlement age is reached and which either continues to be provided once the said age is reached or is replaced by another old-age benefit; (y) "refugee" has the meaning assigned to it in Article 1 of the Convention relating to the Status of Refugees, signed in Geneva on 28 July 1951; (z) "registered office or place of business" means the registered office or place of business where the essential decisions of the undertaking are adopted and where the functions of its central administration are carried out; (aa) "residence" means the place where a person habitually resides; (bb) "special non-contributory cash benefits" means those non-contributory cash benefits which: (i) are intended to provide either: (A) supplementary, substitute or ancillary cover against the risks covered by the branches of social security referred to in Article SSC.3(1), and which guarantee the persons concerned a minimum subsistence income having regard to the economic and social situation in the State concerned; or (B) solely specific protection for the disabled, closely linked to the said person's social environment in the State concerned, and (ii) where the financing exclusively derives from compulsory taxation intended to cover general public expenditure and the conditions for providing and for calculating the benefits are not dependent on any contribution in respect of the beneficiary. However, benefits provided to supplement a contributory benefit shall not be considered to be contributory benefits for this reason alone; (cc) "special scheme for civil servants" means any social security scheme which is different from the general social security scheme applicable to employed persons in the State concerned and to which all, or certain categories of, civil servants are directly subject; (dd) " stateless person" has the meaning assigned to it in Article 1 of the Convention relating to the Status of Stateless Persons, signed in New York on 28 September 1954; (ee) "stay" means temporary residence. Article SSC.2 Persons covered This Protocol applies to persons, including stateless persons and refugees, who are or have been subject to the legislation of one or more States, as well as to the members of their families and their survivors. Article SSC.3 Matters covered 1. This Protocol applies to the following branches of social security: (a) sickness benefits; (b) maternity and equivalent paternity benefits; (c) invalidity benefits; (d) old-age benefits; (e) survivors' benefits; (f) benefits in respect of accidents at work and occupational diseases; (g) death grants; (h) unemployment benefits; (i) pre-retirement benefits. 2. Unless otherwise provided for in Annex SSC-6, this Protocol applies to general and special social security schemes, whether contributory or non-contributory, and to schemes relating to the obligations of an employer or ship-owner. 3. The provisions of Title III do not, however, affect the legislative provisions of any State concerning a ship-owner's obligations. 4. This Protocol does not apply to: (a) special non-contributory cash benefits which are listed in Part 1 of Annex SSC-1; (b) social and medical assistance; (c) benefits in relation to which a State assumes the liability for damages to persons and provides for compensation, such as those for victims of war and military action or their consequences; victims of crime, assassination or terrorist acts; victims of damage occasioned by agents of the State in the course of their duties; or victims who have suffered a disadvantage for political or religious reasons or for reasons of descent; (d) long-term care benefits which are listed in Part 2 of Annex SSC-1; (e) assisted reproduction services; (f) payments which are connected to a branch of social security listed in paragraph 1 and which are: (i) paid to meet expenses for heating in cold weather; and (ii) listed in Part 3 of Annex SSC-1; (g) family benefits. Article SSC.4 Non-discrimination between Member States 1. Social security coordination arrangements established in this Protocol shall be based on the principle of non-discrimination between the Member States. 2. This Article is without prejudice to any arrangements made between the United Kingdom and Ireland concerning the Common Travel Area. Article SSC.5 Equality of treatment 1. Unless otherwise provided for in this Protocol, as regards the branches of social security covered by Article SSC.3(1), persons to whom this Protocol applies shall enjoy the same benefits and be subject to the same obligations under the legislation of any State as the nationals thereof. 2. This provision does not apply to the matters referred to in Article SSC.3(4). Article SSC.6 Equal treatment of benefits, income, facts or events Unless otherwise provided for in this Protocol, the States shall ensure the application of the principle of equal treatment of benefits, income, facts or events in the following manner: (a) where, under the legislation of the competent State, the receipt of social security benefits and other income has certain legal effects, the relevant provisions of that legislation shall also apply to the receipt of equivalent benefits acquired under the legislation of another State or to income acquired in another State; (b) where, under the legislation of the competent State, legal effects are attributed to the occurrence of certain facts or events, that State shall take account of like facts or events that have occurred in any other State as though they had taken place in its own territory. Article SSC.7 Aggregation of periods Unless otherwise provided for in this Protocol, the competent institution of a State shall, to the extent necessary, take into account periods of insurance, employment, self-employment or residence completed under the legislation of any other State as though they were periods completed under the legislation which it applies, where its legislation makes conditional upon the completion of periods of insurance, employment, self-employment or residence: (a) the acquisition, retention, duration or recovery of the right to benefits; (b) the coverage by legislation; or (c) the access to or the exemption from compulsory, optional continued or voluntary insurance. Article SSC.8 Waiving of residence rules The States shall ensure the application of the principle of exportability of cash benefits in accordance with points (a) and (b): (a) Cash benefits payable under the legislation of a State or under this Protocol shall not be subject to any reduction, amendment, suspension, withdrawal or confiscation on account of the fact that the beneficiary or the members of their family reside in a State other than that in which the institution responsible for providing benefits is situated. (b) Point (a) does not apply to the cash benefits covered by points (c) and (h) of Article SSC.3(1). Article SSC.9 Preventing of overlapping of benefits Unless otherwise provided, this Protocol shall neither confer nor maintain the right to several benefits of the same kind for one and the same period of compulsory insurance. TITLE II DETERMINATION OF THE LEGISLATION APPLICABLE Article SSC.10 General rules 1. Persons to whom this Protocol applies shall be subject to the legislation of a single State only. Such legislation shall be determined in accordance with this Title. 2. For the purposes of this Title, persons receiving cash benefits because or as a consequence of their activity as an employed or self-employed person shall be considered to be pursuing the said activity. This shall not apply to invalidity, old-age or survivors' pensions or to pensions in respect of accidents at work or occupational diseases or to sickness benefits in cash covering treatment for an unlimited period. 3. Subject to Articles SSC.11, SSC.12 and SSC.13: (a) a person pursuing an activity as an employed or self-employed person in a State shall be subject to the legislation of that State; (b) a civil servant shall be subject to the legislation of the State to which the administration employing them is subject; (c) any other person to whom points (a) and (b) do not apply shall be subject to the legislation of the State of residence, without prejudice to other provisions of this Protocol guaranteeing them benefits under the legislation of one or more other States. 4. For the purposes of this Title, an activity as an employed or self-employed person normally pursued on board a vessel at sea flying the flag of a State shall be deemed to be an activity pursued in the said State. However, a person employed on board a vessel flying the flag of a State and remunerated for such activity by an undertaking or a person whose registered office or place of business is in another State shall be subject to the legislation of the latter State if that person resides in that State. The undertaking or person paying the remuneration shall be considered as the employer for the purposes of the said legislation. 5. An activity as a flight crew or cabin crew member performing air passenger or freight services shall be deemed to be an activity pursued in the State where the home base is located. Article SSC.11 Detached workers 1. By way of derogation from Article SSC.10(3) and as a transitional measure in relation to the situation that existed before the entry into force of this Agreement, the following rules as regards the applicable legislation apply between the Member States listed in Category A of Annex SSC-8 and the United Kingdom: (a) a person who pursues an activity as an employed person in a State for an employer which normally carries out its activities there and who is sent by that employer to another State to perform work on that employer's behalf shall continue to be subject to the legislation of the first State, provided that: (i) the duration of such work does not exceed 24 months; and (ii) that person is not sent to replace another detached worker. (b) a person who normally pursues an activity as a self-employed person in a State who goes to pursue a similar activity in another State shall continue to be subject to the legislation of the first State, provided that the anticipated duration of such activity does not exceed 24 months. 2. By the date of entry into force of this Agreement, the Union shall notify the United Kingdom which of the following categories each Member State falls under: (a) Category A: The Member State has notified the Union that it wishes to derogate from Article SSC.10 in accordance with this Article; (b) Category B: The Member State has notified the Union that it does not wish to derogate from Article SSC.10; or (c) Category C: The Member State has not indicated whether it wishes to derogate from Article SSC.10. 3. The document referred to in paragraph 2 shall become the content of Annex SSC-8 on the date of entry into force of this Agreement. 4. For Member States which are listed in Category A on the date of entry into force of this Agreement, points (a) and (b) of paragraph 1 shall apply. 5. For Member States which are listed in Category C on the date of entry into force of this Agreement, points (a) and (b) of paragraph 1 shall apply as though that Member State was listed in Category A for one month after the date of entry into force of this Agreement. The Specialised Committee on Social Security Coordination shall move a Member State from Category C to Category A if the Union notifies the Specialised Committee on Social Security Coordination that that Member State wishes to be so moved. 6. A month after the date of entry into force of this Agreement, Categories B and C will cease to exist. The Parties shall publish an updated Annex SSC-8 as soon as possible thereafter. For the purpose of paragraph 1, Annex SSC-8 will be considered as containing only Category A Member States as from the date of that publication. 7. Where a person is in a situation referred to in paragraph 1 involving a Category C Member State before the publication of an updated Annex SSC-8 in accordance with paragraph 6, paragraph 1 shall continue to apply to that person for the duration of their activities under paragraph 1. 8. The Union shall notify the Specialised Committee on Social Security Coordination if a Member State wishes to be removed from Category A of Annex SSC-8 and the Specialised Committee on Social Security Coordination shall, at the request of the Union, remove that Member State from Category A of Annex SSC-8. The Parties shall publish an updated Annex SSC-8 which shall apply as from the first day of the second month following the receipt of the request by the Specialised Committee on Social Security Coordination. 9. Where a person is in a situation referred to in paragraph 1 before the publication of an updated Annex SSC-8 in accordance with paragraph 8, paragraph 1 shall continue to apply to that person for the duration of that person's activities under paragraph 1. Article SSC.12 Pursuit of activities in two or more States 1. A person who normally pursues an activity as an employed person in one or more Member States as well as in the United Kingdom shall be subject to: (a) the legislation of the State of residence if that person pursues a substantial part of their activity in that State; or (b) if that person does not pursue a substantial part of their activity in the State of residence: (i) the legislation of the State in which the registered office or place of business of the undertaking or employer is situated if that person is employed by one undertaking or employer; or (ii) the legislation of the State in which the registered office or place of business of the undertakings or employers is situated if that person is employed by two or more undertakings or employers which have their registered office or place of business in only one State; or (iii) the legislation of the State in which the registered office or place of business of the undertaking or employer is situated other than the State of residence if that person is employed by two or more undertakings or employers, which have their registered office or place of business in a Member State and the United Kingdom, one of which is the State of residence; or (iv) the legislation of the State of residence if that person is employed by two or more undertakings or employers, at least two of which have their registered office or place of business in different States other than the State of residence. 2. A person who normally pursues an activity as a self-employed person in one or more Member States as well as in the United Kingdom shall be subject to: (a) the legislation of the State of residence if that person pursues a substantial part of their activity in that State; or (b) the legislation of the State in which the centre of interest of their activities is situated, if that person does not reside in one of the States in which that person pursues a substantial part of their activity. 3. A person who normally pursues an activity as an employed person and an activity as a self-employed person in two or more States shall be subject to the legislation of the State in which that person pursues an activity as an employed person or, if that person pursues such an activity in two or more States, to the legislation determined in accordance with paragraph 1. 4. A person who is employed as a civil servant by a State and who pursues an activity as an employed person or as a self-employed person in one or more other States shall be subject to the legislation of the State to which the administration employing that person is subject. 5. A person who normally pursues an activity as an employed person in two or more Member States (and not in the United Kingdom) shall be subject to the legislation of the United Kingdom if that person does not pursue a substantial part of that activity in the State of residence and that person: (a) is employed by one or more undertakings or employers, all of which have their registered office or place of business in the United Kingdom; (b) resides in a Member State and is employed by two or more undertakings or employers, all of which have their registered office or place of business in the United Kingdom and the Member State of residence; (c) resides in the United Kingdom and is employed by two or more undertakings or employers, at least two of which have their registered office or place of business in different Member States; or (d) resides in the United Kingdom and is employed by one or more undertakings or employers, none of which have a registered office or place of business in another State. 6. A person who normally pursues an activity as a self-employed person in two or more Member States (and not in the United Kingdom), without pursuing a substantial part of that activity in the State of residence, shall be subject to the legislation of the United Kingdom if the centre of interest of their activity is situated in the United Kingdom. 7. Paragraph 6 shall not apply in the case of a person who normally pursues an activity as an employed person and as a self-employed person in two or more Member States. 8. Persons referred to in paragraphs 1 to 6 shall be treated, for the purposes of the legislation determined in accordance with these provisions, as though they were pursuing all their activities as employed or self-employed persons and were receiving all their income in the State concerned. Article SSC.13 Voluntary insurance or optional continued insurance 1. Articles SSC.10, SSC.11 and SSC.12 do not apply to voluntary insurance or to optional continued insurance unless, in respect of one of the branches referred to in Article SSC.3, only a voluntary scheme of insurance exists in a State. 2. Where, by virtue of the legislation of a State, the person concerned is subject to compulsory insurance in that State, that person may not be subject to a voluntary insurance scheme or an optional continued insurance scheme in another State. In all other cases in which, for a given branch, there is a choice between several voluntary insurance schemes or optional continued insurance schemes, the person concerned shall join only the scheme of their choice. 3. However, in respect of invalidity, old-age and survivors' benefits, the person concerned may join the voluntary or optional continued insurance scheme of a State, even if that person is compulsorily subject to the legislation of another State, provided that that person has been subject, at some stage in his or her career, to the legislation of the first State because or as a consequence of an activity as an employed or self-employed person and if such overlapping is explicitly or implicitly allowed under the legislation of the first State. 4. Where the legislation of a State makes admission to voluntary insurance or optional continued insurance conditional upon residence in that State or upon previous activity as an employed or self-employed person, point (b) of Article SSC.6 shall apply only to persons who have been subject, at some earlier stage, to the legislation of that State on the basis of an activity as an employed or self-employed person. Article SSC.14 Obligations of the employer 1. An employer who has its registered office or place of business outside the competent State shall fulfil all the obligations laid down by the legislation applicable to its employees, notably the obligation to pay the contributions provided for by that legislation, as if it had its registered office or place of business in the competent State. 2. An employer who does not have a place of business in the State whose legislation is applicable and the employee may agree that the latter may fulfil the employer's obligations on its behalf as regards the payment of contributions without prejudice to the employer's underlying obligations. The employer shall send notice of such an arrangement to the competent institution of that State. TITLE III SPECIAL PROVISIONS CONCERNING THE VARIOUS CATEGORIES OF BENEFITS CHAPTER 1 SICKNESS, MATERNITY AND EQUIVALENT PATERNITY BENEFITS SECTION 1 INSURED PERSONS AND MEMBERS OF THEIR FAMILIES EXCEPT PENSIONERS AND MEMBERS OF THEIR FAMILIES Article SSC.15 Residence in a State other than the competent State An insured person or members of their family who reside in a State other than the competent State shall receive in the State of residence benefits in kind provided, on behalf of the competent institution, by the institution of the place of residence, in accordance with the legislation it applies, as though the persons concerned were insured under the said legislation. Article SSC.16 Stay in the competent State when residence is in another State – special rules for the members of the families of frontier workers 1. Unless otherwise provided for by paragraph 2, the insured person and the members of their family referred to in Article SSC.15 shall also be entitled to benefits in kind while staying in the competent State. The benefits in kind shall be provided by the competent institution and at its own expense, in accordance with the legislation it applies, as though the persons concerned resided in that State. 2. The members of the family of a frontier worker shall be entitled to benefits in kind during their stay in the competent State. Where the competent State is listed in Annex SSC-2 however, the members of the family of a frontier worker who reside in the same State as the frontier worker shall be entitled to benefits in kind in the competent State only under the conditions laid down in Article SSC.17(1). Article SSC.17 Stay outside the competent State 1. Unless otherwise provided for by paragraph 2, an insured person and the members of their family staying in a State other than the competent State shall be entitled to benefits in kind, provided on behalf of the competent institution by the institution of the place of stay in accordance with the legislation it applies, as though the persons concerned were insured under that legislation, where: (a) the benefits in kind become necessary on medical grounds during their stay, in the opinion of the provider of the benefits in kind, taking into account the nature of the benefits and the expected length of the stay; (b) the person did not travel to that State with the purpose of receiving the benefits in kind, unless the person is a passenger or member of the crew on a vessel or aircraft travelling to that State and the benefits in kind became necessary on medical grounds during the voyage or flight; and (c) a valid entitlement document is presented in accordance with Article SSCI.22(1) of Annex SSC-7. 2. Appendix SSCI-2 to Annex SSC-7 lists benefits in kind which, in order to be provided during a stay in another State, require for practical reasons a prior agreement between the person concerned and the institution providing the care. Article SSC.18 Travel with the purpose of receiving benefits in kind – authorisation to receive appropriate treatment outside the State of residence 1. Unless otherwise provided for in this Protocol, an insured person travelling to another State with the purpose of receiving benefits in kind during the stay shall seek authorisation from the competent institution. 2. An insured person who is authorised by the competent institution to go to another State with the purpose of receiving the treatment appropriate to their condition shall receive the benefits in kind provided, on behalf of the competent institution, by the institution of the place of stay, in accordance with the legislation it applies, as though that person were insured under the said legislation. The authorisation shall be accorded where the treatment in question is among the benefits provided for by the legislation in the State where the person concerned resides and where that person cannot be given such treatment within a time limit which is medically justifiable, taking into account their current state of health and the probable course of their illness. 3. Paragraphs 1 and 2 apply mutatis mutandis to the members of the family of an insured person. 4. If the members of the family of an insured person reside in a State other than the State in which the insured person resides, and this State has opted for reimbursement on the basis of fixed amounts, the cost of the benefits in kind referred to in paragraph 2 shall be borne by the institution of the place of residence of the members of the family. In this case, for the purposes of paragraph 1, the institution of the place of residence of the members of the family shall be considered to be the competent institution. Article SSC.19 Cash benefits 1. An insured person and members of their family residing or staying in a State other than the competent State shall be entitled to cash benefits provided by the competent institution in accordance with the legislation it applies. By agreement between the competent institution and the institution of the place of residence or stay, such benefits may, however, be provided by the institution of the place of residence or stay at the expense of the competent institution in accordance with the legislation of the competent State. 2. The competent institution of a State whose legislation stipulates that the calculation of cash benefits shall be based on average income or on an average contribution basis shall determine such average income or average contribution basis exclusively by reference to the incomes confirmed as having been paid, or contribution bases applied, during the periods completed under the said legislation. 3. The competent institution of a State whose legislation provides that the calculation of cash benefits shall be based on standard income shall take into account exclusively the standard income or, where appropriate, the average of standard incomes for the periods completed under the said legislation. 4. Paragraphs 2 and 3 apply mutatis mutandis to cases where the legislation applied by the competent institution lays down a specific reference period which corresponds in the case in question either wholly or partly to the periods which the person concerned has completed under the legislation of one or more other States. Article SSC.20 Pension claimants 1. An insured person who, on making a claim for a pension, or during the investigation thereof, ceases to be entitled to benefits in kind under the legislation of the State last competent, shall remain entitled to benefits in kind under the legislation of the State in which that person resides, provided that the pension claimant satisfies the insurance conditions of the legislation of the State referred to in paragraph 2. The right to benefits in kind in the State of residence shall also apply to the members of the family of the pension claimant. 2. The benefits in kind shall be chargeable to the institution of the State which, in the event of a pension being awarded, would become competent under Articles SSC.21, SSC.22 and SSC.23. SECTION 2 SPECIAL PROVISIONS FOR PENSIONERS AND MEMBERS OF THEIR FAMILIES Article SSC.21 Right to benefits in kind under the legislation of the State of residence A person who receives a pension or pensions under the legislation of two or more States, of which one is the State of residence, and who is entitled to benefits in kind under the legislation of that State, shall, with the members of their family, receive such benefits in kind from and at the expense of the institution of the place of residence, as though that person were a pensioner whose pension was payable solely under the legislation of that State. Article SSC.22 No right to benefits in kind under the legislation of the State of residence 1. A person who: (a) resides in a State; (b) receives a pension or pensions under the legislation of one or more States; and (c) is not entitled to benefits in kind under the legislation of the State of residence, shall nevertheless receive such benefits for themselves and the members of their family, insofar as the pensioner would be entitled to them under the legislation of the State competent in respect of their pension or at least one of the States competent, if that person resided in that State. The benefits in kind shall be provided at the expense of the institution referred to in paragraph 2 by the institution of the place of residence, as though the person concerned were entitled to a pension and entitled to benefits in kind under the legislation of that State. 2. In the cases covered by paragraph 1, the cost of the benefits in kind shall be borne by the institution as determined in accordance with the following rules: (a) where the pensioner is treated as if he or she were entitled to benefits in kind under the legislation of one State, the cost of those benefits shall be borne by the competent institution of that State; (b) where the pensioner is treated as if he or she were entitled to benefits in kind under the legislation of two or more States, the cost of those benefits shall be borne by the competent institution of the State to whose legislation the person has been subject for the longest period of time; (c) if the application of the rule in point (b) would result in several institutions being responsible for the cost of those benefits, the cost shall be borne by the competent institution of the State to whose legislation the pensioner was last subject. Article SSC.23 Pensions under the legislation of one or more States other than the State of residence, where there is a right to benefits in kind in the latter State Where a person receiving a pension or pensions under the legislation of one or more States resides in a State under whose legislation the right to receive benefits in kind is not subject to conditions of insurance, or conditions of activity as an employed or self-employed person, and that person does not receive a pension from the State of residence, the cost of benefits in kind provided to them and to members of their family shall be borne by the institution of one of the States competent in respect of the person's pensions determined in accordance with Article SSC.22(2), to the extent that the person and the members of their family would be entitled to such benefits if they resided in that State. Article SSC.24 Residence of members of the family in a State other than the one in which the pensioner resides Where a person: (a) receives a pension or pensions under the legislation of one or more States; and (b) resides in a State other than the one in which members of his or her family reside, those members of that person's family shall be entitled to receive benefits in kind from the institution of the place of their residence in accordance with the legislation it applies insofar as the pensioner is entitled to benefits in kind under the legislation of a State. The costs shall be borne by the competent institution responsible for the costs of the benefits in kind provided to the pensioner in their State of residence. Article SSC.25 Stay of the pensioner or the members of their family in a State other than the State of residence – stay in the competent State – authorisation for appropriate treatment outside the State of residence 1. Article SSC.17 applies mutatis mutandis to: (a) a person receiving a pension or pensions under the legislation of one or more States and who is entitled to benefits in kind under the legislation of one of the States which provide their pension(s); (b) the members of their family, who are staying in a State other than the one in which they reside. 2. Article SSC.16(1) applies mutatis mutandis to the persons described in paragraph 1 when they stay in the State in which is situated the competent institution responsible for the cost of the benefits in kind provided to the pensioner in his or her State of residence and that State has opted for this and is listed in Annex SSC-3. 3. Article SSC.18 applies mutatis mutandis to a pensioner or members of his or her family who are staying in a State other than the one in which they reside with the purpose of receiving in that State the treatment appropriate to their condition. 4. Unless otherwise provided for by paragraph 5, the cost of the benefits in kind referred to in paragraphs 1 to 3 shall be borne by the competent institution responsible for the cost of benefits in kind provided to the pensioner in their State of residence. 5. The cost of the benefits in kind referred to in paragraph 3 shall be borne by the institution of the place of residence of the pensioner or of the members of their family, if these persons reside in a State which has opted for reimbursement on the basis of fixed amounts. In these cases, for the purposes of paragraph 3, the institution of the place of residence of the pensioner or of the members of their family shall be considered to be the competent institution. Article SSC.26 Cash benefits for pensioners 1. Cash benefits shall be paid to a person receiving a pension or pensions under the legislation of one or more States by the competent institution of the State in which is situated the competent institution responsible for the cost of benefits in kind provided to the pensioner in their State of residence. Article SSC.19 applies mutatis mutandis. 2. Paragraph 1 also applies to the members of a pensioner's family. Article SSC.27 Contributions by pensioners 1. The institution of a State which is responsible under the legislation it applies for making deductions in respect of contributions for sickness, maternity and equivalent paternity benefits, may request and recover such deductions, calculated in accordance with the legislation it applies, only to the extent that the cost of the benefits pursuant to Articles SSC.21 to SSC.24 is to be borne by an institution of that State. 2. Where, in the cases referred to in Article SSC.23, the acquisition of sickness, maternity and equivalent paternity benefits is subject to the payment of contributions or similar payments under the legislation of a State in which the pensioner concerned resides, these contributions shall not be payable by virtue of such residence. SECTION 3 COMMON PROVISIONS Article SSC.28 General provisions Articles SSC.21 to SSC.27 do not apply to a pensioner or the members of the pensioner's family who are entitled to benefits under the legislation of a State on the basis of an activity as an employed or self-employed person. In such cases, the person concerned shall be subject, for the purposes of this Chapter, to Articles SSC.15 to SSC.19. Article SSC.29 Prioritising of the right to benefits in kind – special rule for the right of members of the family to benefits in the State of residence 1. Unless otherwise provided for by paragraphs 2 and 3, where a member of the family has an independent right to benefits in kind based on the legislation of a State or on this Chapter such right shall take priority over a derivative right to benefits in kind for members of the family. 2. Unless otherwise provided for by paragraph 3, where the independent right in the State of residence exists directly and solely on the basis of the residence of the person concerned in that State, a derivative right to benefits in kind shall take priority over the independent right. 3. Notwithstanding paragraphs 1 and 2, benefits in kind shall be provided to the members of the family of an insured person at the expense of the competent institution in the State in which they reside, where: (a) those members of the family reside in a State under whose legislation the right to benefits in kind is not subject to conditions of insurance or activity as an employed or self-employed person; and (b) the spouse or the person caring for the children of the insured person pursues an activity as an employed or self-employed person in that State, or receives a pension from that State on the basis of an activity as an employed or self-employed person. Article SSC.30 Reimbursements between institutions 1. The benefits in kind provided by the institution of a State on behalf of the institution of another State under this Chapter shall give rise to full reimbursement. 2. The reimbursements referred to in paragraph 1 shall be determined and effected in accordance with the arrangements set out in Annex SSC-7, either on production of proof of actual expenditure, or on the basis of fixed amounts for States whose legal or administrative structures are such that the use of reimbursement on the basis of actual expenditure is not appropriate. 3. The States, and their competent authorities, may provide for other methods of reimbursement or waive all reimbursement between the institutions coming under their jurisdiction. CHAPTER 2 BENEFITS IN RESPECT OF ACCIDENTS AT WORK AND OCCUPATIONAL DISEASES Article SSC.31 Right to benefits in kind and in cash 1. Without prejudice to any more favourable provisions in paragraphs 2 and 3 of this Article, Article SSC.15 and Articles SSC.16(1), SSC.17(1) and SSC.18(1) also apply to benefits relating to accidents at work or occupational diseases. 2. A person who has sustained an accident at work or has contracted an occupational disease and who resides or stays in a State other than the competent State shall be entitled to the special benefits in kind of the scheme covering accidents at work and occupational diseases provided, on behalf of the competent institution, by the institution of the place of residence or stay in accordance with the legislation which it applies, as though that person were insured under that legislation. 3. The competent institution may not refuse to grant the authorisation provided for in Article SSC.18(1) to a person who has sustained an accident at work or who has contracted an occupational disease and is entitled to benefits chargeable to that institution, where the treatment appropriate to his or her condition cannot be given in the State in which that person resides within a time limit which is medically justifiable, taking into account that person's current state of health and the probable course of the illness. 4. Article SSC.19 also applies to benefits falling within this Chapter. Article SSC.32 Costs of transport 1. The competent institution of a State whose legislation provides for meeting the costs of transporting a person who has sustained an accident at work or is suffering from an occupational disease, either to their place of residence or to a hospital, shall meet such costs to the corresponding place in the State where the person resides, provided that that institution gives prior authorisation for such transport, duly taking into account the reasons justifying it. Such authorisation shall not be required in the case of a frontier worker. 2. The competent institution of a State whose legislation provides for meeting the costs of transporting the body of a person killed in an accident at work to the place of burial shall, in accordance with the legislation it applies, meet such costs to the corresponding place in the State where the person was residing at the time of the accident. Article SSC.33 Benefits for an occupational disease where the person suffering from such a disease has been exposed to the same risk in several States When a person who has contracted an occupational disease has, under the legislation of two or more States, pursued an activity which by its nature is likely to cause the said disease, the benefits that that person or his or her survivors may claim shall be provided exclusively under the legislation of the last of those States whose conditions are satisfied. Article SSC.34 Aggravation of an occupational disease In the event of aggravation of an occupational disease for which a person suffering from such a disease has received or is receiving benefits under the legislation of a State, the following rules shall apply: (a) if the person concerned, while in receipt of benefits, has not pursued, under the legislation of another State, an activity as an employed or self-employed person likely to cause or aggravate the disease in question, the competent institution of the first State shall bear the cost of the benefits under the provisions of the legislation which it applies, taking into account the aggravation; (b) if the person concerned, while in receipt of benefits, has pursued such an activity under the legislation of another State, the competent institution of the first State shall bear the cost of the benefits under the legislation it applies without taking the aggravation into account. The competent institution of the second State shall grant a supplement to the person concerned, the amount of which shall be equal to the difference between the amount of benefits due after the aggravation and the amount which would have been due prior to the aggravation under the legislation it applies, if the disease in question had occurred under the legislation of that State; (c) the rules concerning reduction, suspension or withdrawal laid down by the legislation of a State shall not be invoked against persons receiving benefits provided by institutions of two States in accordance with point (b). Article SSC.35 Rules for taking into account the special features of certain legislation 1. If there is no insurance against accidents at work or occupational diseases in the State in which the person concerned resides or stays, or if such insurance exists but there is no institution responsible for providing benefits in kind, those benefits shall be provided by the institution of the place of residence or stay responsible for providing benefits in kind in the event of sickness. 2. If there is no insurance against accidents at work or occupational diseases in the competent State, the provisions of this Chapter concerning benefits in kind shall nevertheless be applied to a person who is entitled to those benefits in the event of sickness, maternity or equivalent paternity under the legislation of that State if that person sustains an accident at work or suffers from an occupational disease during a residence or stay in another State. Costs shall be borne by the institution that is competent for the benefits in kind under the legislation of the competent State. 3. Article SSC.6 applies to the competent institution in a State as regards the equivalence of accidents at work and occupational diseases which either have occurred or have been confirmed subsequently under the legislation of another State when assessing the degree of incapacity, the right to benefits or the amount thereof, on condition that: (a) no compensation is due in respect of an accident at work or an occupational disease which had occurred or had been confirmed previously under the legislation it applies; and (b) no compensation is due in respect of an accident at work or an occupational disease which had occurred or had been confirmed subsequently, under the legislation of the other State under which the accident at work or the occupational disease had occurred or been confirmed. Article SSC.36 Reimbursements between institutions 1. Article SSC.30 also applies to benefits falling within this Chapter, and reimbursement shall be made on the basis of actual costs. 2. The States, or their competent authorities, may provide for other methods of reimbursement or waive all reimbursement between the institutions under their jurisdiction. CHAPTER 3 DEATH GRANTS Article SSC.37 Right to grants where death occurs in, or where the person entitled resides in, a State other than the competent one 1. When an insured person or a member of their family dies in a State other than the competent State, the death shall be deemed to have occurred in the competent State. 2. The competent institution shall be obliged to provide death grants payable under the legislation it applies, even if the person entitled resides in a State other than the competent State. 3. Paragraphs 1 and 2 shall also apply when the death is the result of an accident at work or an occupational disease. Article SSC.38 Provision of benefits in the event of the death of a pensioner 1. In the event of the death of a pensioner who was entitled to a pension under the legislation of one State, or to pensions under the legislations of two or more States, when that pensioner was residing in a State other than that of the institution responsible for the cost of benefits in kind provided under Articles SSC.22 and SSC.23, the death grants payable under the legislation administered by that institution shall be provided at its own expense as though the pensioner had been residing at the time of their death in the State in which that institution is situated. 2. Paragraph 1 applies mutatis mutandis to the members of the family of a pensioner. CHAPTER 4 INVALIDITY BENEFITS Article SSC.39 Calculation of invalidity benefits Without prejudice to Article SSC.7, where, under the legislation of the State competent under Title II of this Protocol, the amount of invalidity benefits is dependent on the duration of the periods of insurance, employment, self-employment or residence, the competent State is not required to take into account any such periods completed under the legislation of another State for the purposes of calculating the amount of invalidity benefit payable. Article SSC.40 Special provisions on aggregation of periods The competent institution of a State whose legislation makes the acquisition, retention or recovery of the right to benefits conditional upon the completion of periods of insurance or residence shall, where necessary, apply Article SSC.46 mutatis mutandis. Article SSC.41 Aggravation of invalidity In the case of aggravation of an invalidity for which a person is receiving benefits under the legislation of a State in accordance with this Protocol, the benefit shall continue to be provided in accordance with this Chapter, taking the aggravation into account. Article SSC.42 Conversion of invalidity benefits into old-age benefits 1. Where provided for in the legislation of the State paying invalidity benefit in accordance with this Protocol, invalidity benefits shall be converted into old-age benefits under the conditions laid down by the legislation under which they are provided and in accordance with Chapter 5 of Title III. 2. Where a person receiving invalidity benefits can establish a claim to old-age benefits under the legislation of one or more other States, in accordance with Article SSC.45, any institution which is responsible for providing invalidity benefits under the legislation of a State shall continue to provide such a person with the invalidity benefits to which he or she is entitled under the legislation it applies until paragraph 1 becomes applicable in respect of that institution, or otherwise for as long as the person concerned satisfies the conditions for such benefits. Article SSC.43 Special provisions for civil servants Articles SSC.7, SSC.39, SSC.41, SSC.42 and Article SSC.55(2) and (3) apply mutatis mutandis to persons covered by a special scheme for civil servants. CHAPTER 5 OLD-AGE AND SURVIVORS' PENSIONS Article SSC.44 Taking into account child-raising periods 1. Where, under the legislation of the State which is competent under Title II, no child-raising period is taken into account, the institution of the State whose legislation, according to Title II, was applicable to the person concerned on the grounds that he or she was pursuing an activity as an employed or self-employed person at the date when, under that legislation, the child-raising period started to be taken into account for the child concerned, shall remain responsible for taking into account that period as a child-raising period under its own legislation, as if such child-raising took place in its own territory. 2. Paragraph 1 shall not apply if the person concerned is, or becomes, subject to the legislation of another State due to the pursuit of an employed or self-employed activity. Article SSC.45 General provisions 1. All the competent institutions shall determine entitlement to benefit, under all the legislations of the States to which the person concerned has been subject, when a request for award has been submitted, unless the person concerned expressly requests deferment of the award of old age benefits under the legislation of one or more States. 2. If at a given moment the person concerned does not satisfy, or no longer satisfies, the conditions laid down by all the legislations of the States to which that person has been subject, the institutions applying legislation the conditions of which have been satisfied shall not take into account, when performing the calculation in accordance with point (a) or (b) of Article SSC.47(1), the periods completed under the legislations the conditions of which have not been satisfied, or are no longer satisfied, where this gives rise to a lower amount of benefit. 3. Paragraph 2 shall apply mutatis mutandis when the person concerned has expressly requested deferment of the award of old-age benefits. 4. A new calculation shall be performed automatically as and when the conditions to be fulfilled under the other legislations are satisfied or when a person requests the award of an old-age benefit deferred in accordance with paragraph 1, unless the periods completed under the other legislations have already been taken into account by virtue of paragraph 2 or 3. Article SSC.46 Special provisions on aggregation of periods 1. Where the legislation of a State makes the granting of certain benefits conditional upon the periods of insurance having been completed only in a specific activity as an employed or self-employed person or in an occupation which is subject to a special scheme for employed or self-employed persons, the competent institution of that State shall take into account periods completed under the legislation of other States only if completed under a corresponding scheme or, failing that, in the same occupation, or where appropriate, in the same activity as an employed or self-employed person. If, account having been taken of the periods thus completed, the person concerned does not satisfy the conditions for receipt of the benefits of a special scheme, these periods shall be taken into account for the purposes of providing the benefits of the general scheme or, failing that, of the scheme applicable to manual or clerical workers, as the case may be, provided that the person concerned had been affiliated to one or other of those schemes. 2. The periods of insurance completed under a special scheme of a State shall be taken into account for the purposes of providing the benefits of the general scheme or, failing that, of the scheme applicable to manual or clerical workers, as the case may be, of another State, provided that the person concerned had been affiliated to one or other of those schemes, even if those periods have already been taken into account in the latter State under a special scheme. 3. Where the legislation or specific scheme of a State makes the acquisition, retention or recovery of the right to benefits conditional upon the person concerned being insured at the time of the materialisation of the risk, this condition shall be regarded as having been satisfied if that person has been previously insured under the legislation or specific scheme of that State and is, at the time of the materialisation of the risk, insured under the legislation of another State for the same risk or, failing that, if a benefit is due under the legislation of another State for the same risk. The latter condition shall, however, be deemed to be fulfilled in the cases referred to in Article SSC.52. Article SSC.47 Award of benefits 1. The competent institution shall calculate the amount of the benefit that would be due: (a) under the legislation it applies, only where the conditions for entitlement to benefits have been satisfied exclusively under national law (independent benefit); (b) by calculating a theoretical amount and subsequently an actual amount (pro rata benefit), as follows: (i) the theoretical amount of the benefit is equal to the benefit which the person concerned could claim if all the periods of insurance and/or of residence which have been completed under the legislations of the other States had been completed under the legislation it applies on the date of the award of the benefit. If, under this legislation, the amount does not depend on the duration of the periods completed, that amount shall be regarded as being the theoretical amount; (ii) the competent institution shall then establish the actual amount of the pro rata benefit by applying to the theoretical amount the ratio between the duration of the periods completed before materialisation of the risk under the legislation it applies and the total duration of the periods completed before materialisation of the risk under the legislations of all the States concerned. 2. Where appropriate, the competent institution shall apply, to the amount calculated in accordance with points (a) and (b) of paragraph 1, all the rules relating to reduction, suspension or withdrawal, under the legislation it applies, within the limits provided for by Articles SSC.48, SSC.49 and SSC.50. 3. The person concerned shall be entitled to receive from the competent institution of each State the higher of the amounts calculated in accordance with points (a) and (b) of paragraph 1. 4. Where the calculation pursuant to point (a) of paragraph 1 in one State invariably results in the independent benefit being equal to or higher than the pro rata benefit, calculated in accordance with point (b) of paragraph 1, the competent institution shall waive the pro rata calculation, provided that: (a) such a situation is set out in Part 1 of Annex SSC-4; (b) no legislation containing rules against overlapping, as referred to in Articles SSC.49 and SSC.50, is applicable unless the conditions laid down in Article SSC.50(2) are fulfilled; and (c) Article SSC.52 is not applicable in relation to periods completed under the legislation of another State in the specific circumstances of the case. 5. Notwithstanding paragraphs 1, 2 and 3, the pro rata calculation shall not apply to schemes providing benefits in respect of which periods of time are of no relevance to the calculation, subject to such schemes being listed in Part 2 of Annex SSC-4. In such cases, the person concerned shall be entitled to the benefit calculated in accordance with the legislation of the State concerned. Article SSC.48 Rules to prevent overlapping 1. Any overlapping of old-age and survivors' benefits calculated or provided on the basis of periods of insurance or residence completed by the same person shall be considered to be overlapping of benefits of the same kind. 2. Overlapping of benefits which cannot be considered to be of the same kind within the meaning of paragraph 1 shall be considered to be overlapping of benefits of a different kind. 3. The following provisions shall be applicable for the purposes of rules to prevent overlapping laid down by the legislation of a State in the case of overlapping of a benefit in respect of old age or survivors with a benefit of the same kind or a benefit of a different kind or with other income: (a) the competent institution shall take into account the benefits or incomes acquired in another State only where the legislation it applies provides for benefits or income acquired abroad to be taken into account; (b) the competent institution shall take into account the amount of benefits to be paid by another State before deduction of tax, social security contributions and other individual levies or deductions, unless the legislation it applies provides for the application of rules to prevent overlapping after such deductions, under the conditions and the procedures laid down in Annex SSC-7; (c) the competent institution shall not take into account the amount of benefits acquired under the legislation of another State on the basis of voluntary insurance or continued optional insurance; (d) if a single State applies rules to prevent overlapping because the person concerned receives benefits of the same or of a different kind under the legislation of other States or income acquired in other States, the benefit due may be reduced solely by the amount of such benefits or such income. Article SSC.49 Overlapping of benefits of the same kind 1. Where benefits of the same kind due under the legislation of two or more States overlap, the rules to prevent overlapping laid down by the legislation of a State shall not be applicable to a pro rata benefit. 2. The rules to prevent overlapping shall apply to an independent benefit only if the benefit concerned is: (a) a benefit the amount of which does not depend on the duration of periods of insurance or residence; or (b) a benefit the amount of which is determined on the basis of a credited period deemed to have been completed between the date on which the risk materialised and a later date, overlapping with: (i) a benefit of the same type, except where an agreement has been concluded between two or more States to avoid the same credited period being taken into account more than once; or (ii) a benefit referred to in point (a). The benefits and agreements referred to in points (a) and (b) are listed in Annex SSC-5. Article SSC.50 Overlapping of benefits of a different kind 1. If the receipt of benefits of a different kind or other income requires the application of the rules to prevent overlapping provided for by the legislation of the States concerned regarding: (a) two or more independent benefits, the competent institutions shall divide the amounts of the benefit or benefits or other income, as they have been taken into account, by the number of benefits subject to the said rules; however, the application of this point cannot deprive the person concerned of their status as a pensioner for the purposes of the other chapters of this Title under the conditions and the procedures laid down in Annex SSC-7; (b) one or more pro rata benefits, the competent institutions shall take into account the benefit or benefits or other income and all the elements stipulated for applying the rules to prevent overlapping as a function of the ratio between the periods of insurance and/or residence established for the calculation referred to in point (b)(ii) of Article SSC.47(1); (c) one or more independent benefits and one or more pro-rata benefits, the competent institutions shall apply mutatis mutandis point (a) as regards independent benefits and point (b) as regards pro rata benefits. 2. The competent institution shall not apply the division stipulated in respect of independent benefits, if the legislation it applies provides for account to be taken of benefits of a different kind or other income and all other elements for calculating part of their amount determined as a function of the ratio between periods of insurance and/or residence referred to in point (b)(ii) of Article SSC.47(1). 3. Paragraphs 1 and 2 shall apply mutatis mutandis where the legislation of one or more States provides that a right to a benefit cannot be acquired in the case where the person concerned is in receipt of a benefit of a different kind, payable under the legislation of another State, or of other income. Article SSC.51 Additional provisions for the calculation of benefits 1. For the calculation of the theoretical and pro rata amounts referred to in point (b) of Article SSC.47(1), the following rules apply: (a) where the total length of the periods of insurance and/or residence completed before the risk materialised under the legislations of all the States concerned is longer than the maximum period required by the legislation of one of these States for receipt of full benefit, the competent institution of that State shall take into account this maximum period instead of the total length of the periods completed; this method of calculation shall not result in the imposition on that institution of the cost of a benefit greater than the full benefit provided for by the legislation it applies. This provision shall not apply to benefits the amount of which does not depend on the length of insurance; (b) the procedure for taking into account overlapping periods is laid down in Annex SSC-7; (c) if the legislation of a State provides that the benefits are to be calculated on the basis of incomes, contributions, bases of contributions, increases, earnings, other amounts or a combination of more than one of them (average, proportional, fixed or credited), the competent institution shall: (i) determine the basis for calculation of the benefits in accordance only with periods of insurance completed under the legislation it applies; (ii) use, in order to determine the amount to be calculated in accordance with the periods of insurance and/or residence completed under the legislation of the other States, the same elements determined or recorded for the periods of insurance completed under the legislation it applies; where necessary in accordance with the procedures laid down in Annex SSC-6 for the State concerned; (d) in the event that point (c) is not applicable because the legislation of a State provides for the benefit to be calculated on the basis of elements other than periods of insurance or residence which are not linked to time, the competent institution shall take into account, in respect of each period of insurance or residence completed under the legislation of any other State, the amount of the capital accrued, the capital which is considered as having been accrued or any other element for the calculation under the legislation it administers divided by the corresponding units of periods in the pension scheme concerned. 2. The provisions of the legislation of a State concerning the revalorisation of the elements taken into account for the calculation of benefits shall apply, as appropriate, to the elements to be taken into account by the competent institution of that State, in accordance with paragraph 1, in respect of the periods of insurance or residence completed under the legislation of other States. Article SSC.52 Periods of insurance or residence of less than one year 1. Notwithstanding point (b) of Article SSC.47(1), the institution of a State shall not be required to provide benefits in respect of periods completed under the legislation it applies which are taken into account when the risk materialises, if: (a) the duration of the said periods is less than one year; and (b) taking only these periods into account no right to benefit is acquired under that legislation. For the purposes of this Article, "periods" shall mean all periods of insurance, employment, self-employment or residence which either qualify for, or directly increase, the benefit concerned. 2. The competent institution of each of the States concerned shall take into account the periods referred to in paragraph 1, for the purposes of point (b)(i) of Article SSC.47(1). 3. If the effect of applying paragraph 1 would be to relieve all the institutions of the States concerned of their obligations, benefits shall be provided exclusively under the legislation of the last of those States whose conditions are satisfied, as if all the periods of insurance and residence completed and taken into account in accordance with Article SSC.7 and Article SSC.46(1) and (2) had been completed under the legislation of that State. 4. This Article does not apply to schemes listed in Part 2 of Annex SSC-4. Article SSC.53 Award of a supplement 1. A recipient of benefits to whom this Chapter applies may not, in the State of residence and under whose legislation a benefit is payable to them, be provided with a benefit which is less than the minimum benefit fixed by that legislation for a period of insurance or residence equal to all the periods taken into account for the payment in accordance with this Chapter. 2. The competent institution of that State shall pay them throughout the period of their residence in its territory a supplement equal to the difference between the total of the benefits due under this Chapter and the amount of the minimum benefit. Article SSC.54 Recalculation and revaluation of benefits 1. If the method for determining benefits or the rules for calculating benefits are altered under the legislation of a State, or if the personal situation of the person concerned undergoes a relevant change which, under that legislation, would lead to an adjustment of the amount of the benefit, a recalculation shall be carried out in accordance with Article SSC.47. 2. On the other hand, if, by reason of an increase in the cost of living or changes in the level of income or other grounds for adjustment, the benefits of the State concerned are altered by a percentage or fixed amount, such percentage or fixed amount shall be applied directly to the benefits determined in accordance with Article SSC.47, without the need for a recalculation. Article SSC.55 Special provisions for civil servants 1. Articles SSC.7 and SSC.45, Article SSC.46(3) and Articles SSC.47 to SSC.54 apply mutatis mutandis to persons covered by a special scheme for civil servants. 2. However, if the legislation of a competent State makes the acquisition, liquidation, retention or recovery of the right to benefits under a special scheme for civil servants subject to the condition that all periods of insurance be completed under one or more special schemes for civil servants in that State, or be regarded by the legislation of that State as equivalent to such periods, the competent institution of that State shall take into account only the periods which can be recognised under the legislation it applies. If, account having been taken of the periods thus completed, the person concerned does not satisfy the conditions for the receipt of these benefits, these periods shall be taken into account for the award of benefits under the general scheme or, failing that, the scheme applicable to manual or clerical workers, as the case may be. 3. Where, under the legislation of a State, benefits under a special scheme for civil servants are calculated on the basis of the last salary or salaries received during a reference period, the competent institution of that State shall take into account, for the purposes of the calculation, only those salaries, duly revalued, which were received during the period or periods for which the person concerned was subject to that legislation. CHAPTER 6 UNEMPLOYMENT BENEFITS Article SSC.56 Special provisions on aggregation of periods of insurance, employment or self-employment 1. The competent institution of a State whose legislation makes the acquisition, retention, recovery or duration of the right to benefits conditional upon the completion of either periods of insurance, employment or self-employment shall, to the extent necessary, take into account periods of insurance, employment or self-employment completed under the legislation of any other State as though they were completed under the legislation it applies. However, when the applicable legislation makes the right to benefits conditional on the completion of periods of insurance, the periods of employment or self-employment completed under the legislation of another State shall not be taken into account unless such periods would have been considered to be periods of insurance had they been completed in accordance with the applicable legislation. 2. The application of paragraph 1 of this Article shall be conditional on the person concerned having the most recently completed, in accordance with the legislation under which the benefits are claimed: (a) periods of insurance, if that legislation requires periods of insurance; (b) periods of employment, if that legislation requires periods of employment; or (c) periods of self-employment, if that legislation requires periods of self-employment. Article SSC.57 Calculation of unemployment benefits 1. Where the calculation of unemployment benefits is based on the amount of the previous salary or professional income of the person concerned, the competent State shall take into account the salary or professional income received by the person concerned based exclusively on their last activity as an employed or self-employed person under the legislation of the competent State. 2. Where the legislation applied by the competent State provides for a specific reference period for the determination of the salary or professional income used to calculate the amount of benefit, and the person concerned was subject to the legislation of another State for all or part of that reference period, the competent State shall only take into account the salary or professional income received during their last activity as an employed or self-employed person under that legislation. CHAPTER 7 PRE-RETIREMENT BENEFITS Article SSC.58 Benefits When the applicable legislation makes the right to pre-retirement benefits conditional on the completion of periods of insurance, of employment or of self-employment, Article SSC.7 shall not apply. TITLE IV MISCELLANEOUS PROVISIONS Article SSC.59 Cooperation 1. The competent authorities of the States shall notify the Specialised Committee on Social Security Coordination of any changes to their legislation as regards the branches of social security covered by Article SSC.3 which are relevant to or may affect the implementation of this Protocol. 2. Unless this Protocol requires such information to be notified to the Specialised Committee on Social Security Coordination, the competent authorities of the States shall communicate to each other measures taken to implement this Protocol that are not notified under paragraph 1 and that are relevant for the implementation of this Protocol. 3. For the purposes of this Protocol, the authorities and institutions of the States shall lend one another their good offices and act as though implementing their own legislation. The administrative assistance given by those authorities and institutions shall, as a rule, be free of charge. However, the Specialised Committee on Social Security Coordination shall establish the nature of reimbursable expenses and the limits above which their reimbursement is due. 4. The authorities and institutions of the States may, for the purposes of this Protocol, communicate directly with one another and with the persons involved or their representatives. 5. The institutions and persons covered by this Protocol shall have a duty of mutual information and cooperation to ensure the correct implementation of this Protocol. The institutions, in accordance with the principle of good administration, shall respond to all queries within a reasonable period of time and shall in this connection provide the persons concerned with any information required for exercising the rights conferred on them by this Protocol. The persons concerned must inform the institutions of the competent State and of the State of residence as soon as possible of any change in their personal or family situation which affects their right to benefits under this Protocol. 6. Failure to respect the obligation of information referred to in the third subparagraph of paragraph 5 may result in the application of proportionate measures in accordance with national law. Nevertheless, these measures shall be equivalent to those applicable to similar situations under domestic law and shall not make it impossible or excessively difficult in practice for claimants to exercise the rights conferred on them by this Protocol. 7. In the event of difficulties in the interpretation or application of this Protocol which could jeopardise the rights of a person covered by it, the institution of the competent State or of the State of residence of the person concerned, shall contact the institution(s) of the State(s) concerned. If a solution cannot be found within a reasonable period, a Party may request to hold consultations in the framework of the Specialised Committee on Social Security Coordination. 8. The authorities, institutions and tribunals of one State may not reject applications or other documents submitted to them on the grounds that they are written in an official language of the Union, including in English. Article SSC.60 Data processing 1. The States shall progressively use new technologies for the exchange, access and processing of the data required to apply this Protocol. 2. Each State shall be responsible for managing its own part of the data-processing services. 3. An electronic document sent or issued by an institution in conformity with this Protocol and Annex SSC-7 may not be rejected by any authority or institution of another State on the grounds that it was received by electronic means, once the receiving institution has declared that it can receive electronic documents. Reproduction and recording of such documents shall be presumed to be a correct and accurate reproduction of the original document or representation of the information it relates to, unless there is proof to the contrary. 4. An electronic document shall be considered valid if the computer system on which the document is recorded contains the safeguards necessary in order to prevent any alteration, disclosure or unauthorised access to the recording. It shall at any time be possible to reproduce the recorded information in an immediately readable form. Article SSC.61 Exemptions 1. Any exemption from or reduction of taxes, stamp duty, notarial or registration fees provided for under the legislation of one State in respect of certificates or documents required to be produced in application of the legislation of that State shall be extended to similar certificates or documents required to be produced in application of the legislation of another State or of this Protocol. 2. All statements, documents and certificates of any kind whatsoever required to be produced in application of this Protocol shall be exempt from authentication by diplomatic or consular authorities. Article SSC.62 Claims, declarations or appeals Any claim, declaration or appeal which should have been submitted, in application of the legislation of one State, within a specified period to an authority, institution or tribunal of that State shall be admissible if it is submitted within the same period to a corresponding authority, institution or tribunal of another State. In such a case, the authority, institution or tribunal receiving the claim, declaration or appeal shall forward it without delay to the competent authority, institution or tribunal of the former State either directly or through the competent authorities of the States concerned. The date on which such claims, declarations or appeals were submitted to the authority, institution or tribunal of the second State shall be considered as the date of their submission to the competent authority, institution or tribunal. Article SSC.63 Medical examinations 1. Medical examinations provided for by the legislation of one State may be carried out, at the request of the competent institution, in the territory of another State, by the institution of the place of stay or residence of the person entitled to benefits, under the conditions laid down in Annex SSC-7 or agreed between the competent authorities of the States concerned. 2. Medical examinations carried out under the conditions laid down in paragraph 1 shall be considered as having been carried out in the territory of the competent State. Article SSC.64 Collection of contributions and recovery of benefits 1. Collection of contributions due to an institution of one State and recovery of benefits provided by the institution of one State but not due, may be effected in another State in accordance with the procedures and with the guarantees and privileges applicable to the collection of contributions due to the corresponding institution of the latter and the recovery of benefits provided by it but not due. 2. Enforceable decisions of the judicial and administrative authorities relating to the collection of contributions, interest and any other charges or to the recovery of benefits provided but not due under the legislation of one State shall be recognised and enforced at the request of the competent institution in another State within the limits and in accordance with the procedures laid down by the legislation and any other procedures applicable to similar decisions of the latter. Such decisions shall be declared enforceable in that State insofar as the legislation and any other procedures of that State so require. 3. Claims of an institution of one State shall in enforcement, bankruptcy or settlement proceedings in another State enjoy the same privileges as the legislation that the latter accords to claims of the same kind. 4. The procedure for implementing this Article, including costs reimbursement, shall be governed by Annex SSC-7 or, where necessary and as a complementary measure, by means of agreements between the States. Article SSC.65 Rights of institutions 1. If a person receives benefits under the legislation of a State in respect of an injury resulting from events occurring in another State, any rights of the institution responsible for providing benefits against a third party liable to provide compensation for the injury shall be governed by the following rules: (a) where the institution responsible for providing benefits is, under the legislation it applies, subrogated to the rights which the beneficiary has against the third party, such subrogation shall be recognised by each State; (b) where the institution responsible for providing benefits has a direct right against the third party, each State shall recognise such rights. 2. If a person receives benefits under the legislation of one State in respect of an injury resulting from events occurring in another State, the provisions of the said legislation which determine the cases in which the civil liability of employers or of their employees is to be excluded shall apply with regard to the said person or to the competent institution. Paragraph 1 shall also apply to any rights of the institution responsible for providing benefits against employers or their employees in cases where their liability is not excluded. 3. Where, in accordance with Article SSC.30(3) or SSC.36(2), two or more States or their competent authorities have concluded an agreement to waive reimbursement between institutions under their jurisdiction, or, where reimbursement does not depend on the amount of benefits actually provided, any rights arising against a liable third party shall be governed by the following rules: (a) where the institution of the State of residence or stay grants benefits to a person in respect of an injury sustained in its territory, that institution, in accordance with the provisions of the legislation it applies, shall exercise the right to subrogation or direct action against the third party liable to provide compensation for the injury; (b) for the application of point (a): (i) the person receiving benefits shall be deemed to be insured with the institution of the place of residence or stay, and (ii) that institution shall be deemed to be the institution responsible for providing benefits; (c) paragraphs 1 and 2 shall remain applicable in respect of any benefits not covered by the waiver agreement or a reimbursement which does not depend on the amount of benefits actually provided. Article SSC.66 Implementation of legislation Special provisions for implementing the legislation of a certain State are referred to in Annex SSC-6 to the Protocol. TITLE V FINAL PROVISIONS Article SSC.67 Protection of individual rights 1. The Parties shall ensure in accordance with their domestic legal orders that the provisions of the Protocol on Social Security Coordination have the force of law, either directly or through domestic legislation giving effect to those provisions, so that legal or natural persons can invoke those provisions before domestic courts, tribunals and administrative authorities. 2. The Parties shall ensure the means for legal and natural persons to effectively protect their rights under this Protocol, such as the possibility to address complaints to administrative bodies or to bring legal action before a competent court or tribunal in an appropriate judicial procedure, in order to seek an adequate and timely remedy. Article SSC.68 Amendments The Specialised Committee on Social Security Coordination may amend the Annexes and Appendices to this Protocol. Article SSC.69 Termination of this Protocol Without prejudice to Article 779 of this Agreement, each Party may at any moment terminate this Protocol, by written notification through diplomatic channels. In that event, this Protocol shall cease to be in force on the first day of the ninth month following the date of notification. Article SSC.70 Sunset clause 1. This Protocol shall cease to apply fifteen years after the entry into force of this Agreement. 2. Not less than 12 months before this Protocol ceases to apply in accordance with paragraph 1, either Party shall notify the other Party of its wish to enter into negotiations with a view to concluding an updated Protocol. Article SSC.71 Post-termination arrangements When this Protocol ceases to apply pursuant to Article SSC.69, Article SSC.70 or Article 779 of this Agreement, the rights of insured persons regarding entitlements which are based on periods completed or facts or events that occurred before this Protocol ceases to apply shall be retained. The Partnership Council may lay down additional arrangements setting out appropriate consequential and transitional arrangements in good time before this Protocol ceases to apply. ANNEX SSC-1 CERTAIN BENEFITS IN CASH TO WHICH THIS PROTOCOL SHALL NOT APPLY PART 1 SPECIAL NON-CONTRIBUTORY CASH BENEFITS (Point (a) of Article SSC.3(4) of this Protocol) (i) UNITED KINGDOM (a) State Pension Credit (State Pension Credit Act 2002 and State Pension Credit Act (Northern Ireland) 2002); (b) Income-based allowances for jobseekers (Jobseekers Act 1995 and Jobseekers (Northern Ireland) Order 1995); (c) Disability Living Allowance, mobility component (Social Security Contributions and Benefits Act 1992 and Social Security Contributions and Benefits (Northern Ireland) Act 1992); (d) Personal Independence Payment, mobility component (Welfare Reform Act 2012 (Part 4) and Welfare Reform (Northern Ireland) Order 2015 (Part 5)); (e) Employment and Support Allowance Income-related (Welfare Reform Act 2007 and Welfare Reform Act (Northern Ireland) 2007); (f) Best Start Foods payment (Welfare Foods (Best Start Foods) (Scotland) Regulations 2019 (SSI 2019/193)); (g) Best Start Grants (pregnancy and baby grant, early learning grant, school-age grant) (The Early Years Assistance (Best Start Grants) (Scotland) Regulations 2018 (SSI 2018/370)); (h) Funeral Support Payment (Funeral Expense Assistance (Scotland) Regulations 2019 (SSI 2019/292)). (ii) MEMBER STATES AUSTRIA Compensatory supplement (Federal Act of 9 September 1955 on General Social Insurance — ASVG, Federal Act of 11 October 1978 on Social insurance for persons engaged in trade and commerce — GSVG and Federal Act of 11 October 1978 on Social insurance for farmers — BSVG). BELGIUM (a) Income replacement allowance (Law of 27 February 1987); (b) Guaranteed income for elderly persons (Law of 22 March 2001). BULGARIA Social Pension for old age (Article 89 of the Social Insurance Code). CYPRUS (a) Social Pension (Social Pension Law of 1995 (Law 25(I)/95), as amended); (b) Severe motor disability allowance (Council of Ministers' Decisions Nos 38210 of 16 October 1992, 41370 of 1 August 1994, 46183 of 11 June 1997 and 53675 of 16 May 2001); (c) Special grant to blind persons (Special Grants Law of 1996 (Law 77(I)/96), as amended). CZECH REPUBLIC Social allowance (State Social Support Act No 117/1995 Sb.). DENMARK Accommodation expenses for pensioners (Law on individual accommodation assistance, consolidated by Law No 204 of 29 March 1995). ESTONIA (a) Disabled adult allowance (Social Benefits for Disabled Persons Act of 27 January 1999); (b) State unemployment allowance (Labour Market Services and Support Act of 29 September 2005). FINLAND (a) Housing allowance for pensioners (Act concerning the Housing Allowance for pensioners, 571/2007); (b) Labour market support (Act on Unemployment Benefits 1290/2002); (c) Special assistance for immigrants (Act on Special Assistance for Immigrants, 1192/2002). FRANCE (a) Supplementary allowances of: (i) the Special Invalidity Fund; and (ii) the Old Age Solidarity Fund in respect of acquired rights (Law of 30 June 1956, codified in Book VIII of the Social Security Code); (b) Disabled adults' allowance (Law of 30 June 1975, codified in Book VIII of the Social Security Code); (c) Special allowance (Law of 10 July 1952, codified in Book VIII of the Social Security Code) in respect of acquired rights; (d) Old-age solidarity allowance (ordinance of 24 June 2004, codified in Book VIII of the Social Security Code) as of 1 January 2006. GERMANY (a) Basic subsistence income for the elderly and for persons with reduced earning capacity under Chapter 4 of Book XII of the Social Code; (b) Benefits to cover subsistence costs under the basic provision for jobseekers unless, with respect to these benefits, the eligibility requirements for a temporary supplement following receipt of unemployment benefit (Article 24(1) of Book II of the Social Code) are fulfilled. GREECE Special benefits for the elderly (Law 1296/82). HUNGARY (a) Invalidity annuity (Decree No 83/1987 (XII 27) of the Council of Ministers on Invalidity Annuity); (b) Non-contributory old age allowance (Act III of 1993 on Social Administration and Social Benefits); (c) Transport allowance (Government Decree No 164/1995 (XII 27) on Transport Allowances for Persons with Severe Physical Handicap). IRELAND (a) Jobseekers' allowance (Social Welfare Consolidation Act 2005, Part 3, Chapter 2); (b) State pension (non-contributory) (Social Welfare Consolidation Act 2005, Part 3, Chapter 4); (c) Widow's (non-contributory) pension and widower's (non-contributory) pension (Social Welfare Consolidation Act 2005, Part 3, Chapter 6); (d) Disability allowance (Social Welfare Consolidation Act 2005, Part 3, Chapter 10); (e) Mobility allowance (Health Act 1970, Section 61); (f) Blind pension (Social Welfare Consolidation Act 2005, Part 3, Chapter 5). ITALY (a) Social pensions for persons without means (Law No 153 of 30 April 1969); (b) Pensions and allowances for the civilian disabled or invalids (Laws No 118 of 30 March 1971, No 18 of 11 February 1980 and No 508 of 21 November 1988); (c) Pensions and allowances for the deaf and dumb (Laws No 381 of 26 May 1970 and No 508 of 21 November 1988); (d) Pensions and allowances for the civilian blind (Laws No 382 of 27 May 1970 and No 508 of 21 November 1988); (e) Benefits supplementing the minimum pensions (Laws No 218 of 4 April 1952, No 638 of 11 November 1983 and No 407 of 29 December 1990); (f) Benefits supplementing disability allowances (Law No 222 of 12 June 1984); (g) Social allowance (Law No 335 of 8 August 1995); (h) Social increase (Article 1(1) and (12) of Law No 544 of 29 December 1988 and successive amendments). LATVIA (a) State Social Security Benefit (Law on State Social Benefits of 1 January 2003); (b) Allowance for the compensation of transportation expenses for disabled persons with restricted mobility (Law on State Social Benefits of 1 January 2003). LITHUANIA (a) Social assistance pension (Law of 2005 on State Social Assistance Benefits, Article 5); (b) Relief compensation (Law of 2005 on State Social Assistance Benefits, Article 15); (c) Transport compensation for the disabled who have mobility problems (Law of 2000 on Transport Compensation, Article 7). LUXEMBOURG Income for the seriously disabled (Article 1(2), Law of 12 September 2003), with the exception of persons recognised as being disabled workers and employed on the mainstream labour market or in a sheltered environment. MALTA (a) Supplementary allowance (Section 73 of the Social Security Act (Cap. 318) 1987); (b) Age pension (Social Security Act (Cap. 318) 1987). NETHERLANDS (a) Work and Employment Support for Disabled Young Persons Act of 24 April 1997 (Wet Wajong). (b) Supplementary Benefits Act of 6 November 1986 (TW). POLAND Social pension (Act of 27 June 2003 on social pensions). PORTUGAL (a) Non-contributory State old-age and invalidity pension (Decree-Law No 464/80 of 13 October 1980); (b) Non-contributory widowhood pension (Regulatory Decree No 52/81 of 11 November 1981); (c) Solidarity supplement for the elderly (Decree – Law No 232/2005 of 29 December 2005, amended by Decree – Law No 236/2006 of 11 December 2006). SLOVAKIA (a) Adjustment awarded before 1 January 2004 to pensions constituting the sole source of income; (b) Social pension which has been awarded before 1 January 2004. SLOVENIA (a) State pension (Pension and Disability Insurance Act of 23 December 1999); (b) Income support for pensioners (Pension and Disability Insurance Act of 23 December 1999); (c) Maintenance allowance (Pension and Disability Insurance Act of 23 December 1999). SPAIN (a) Minimum income guarantee (Law No 13/82 of 7 April 1982); (b) Cash benefits to assist the elderly and invalids unable to work (Royal Decree No 2620/81 of 24 July 1981): (i) Non-contributory invalidity and retirement pensions as provided for in Chapter II of Title VI of the Consolidated Text of the General Law on Social Security, approved by Royal Legislative Decree No 8/2015 of 30 October 2015; and (ii) the benefits which supplement the above pensions, as provided for in the legislation of the Comunidades Autonómas, where such supplements guarantee a minimum subsistence income having regard to the economic and social situation in the Comunidades Autonómas concerned; (c) Allowances to promote mobility and to compensate for transport costs (Law No 13/1982 of 7 April 1982). SWEDEN (a) Housing supplements for persons receiving a pension (Law 2001:761); (b) Financial support for the elderly (Law 2001:853). PART 2 LONG-TERM CARE BENEFITS (Point (d) of Article SSC.3(4) of this Protocol) (i) UNITED KINGDOM (a) Attendance Allowance (Social Security Contributions and Benefits Act 1992, Social Security (Attendance Allowance) Regulations 1991, Social Security Contributions and Benefits (Northern Ireland) Act 1992 and Social Security (Attendance Allowance) Regulations (Northern Ireland) 1992); (b) Carer's Allowance (Social Security Contributions and Benefits Act 1992, The Social Security (Invalid Care Allowance) Regulations 1976, Social Security Contributions and Benefits (Northern Ireland) Act 1992) and The Social Security (Invalid Care Allowance) Regulations 1976 (Northern Ireland); (c) Disability Living Allowance, care component (Social Security Contributions and Benefits Act 1992, Social Security (Disability Living Allowance) Regulations 1991, Social Security Contributions and Benefits (Northern Ireland) Act 1992 and Social Security (Disability Living Allowance) Regulations (Northern Ireland) 1992); (d) Personal Independence Payment, daily living component (Welfare Reform Act 2012 (Part 4), Social Security (Personal Independence Payment) Regulations 2013, The Personal Independence Payment (Transitional Provisions) Regulations 2013, Personal Independence Payment (Transitional Provisions) (Amendment) Regulations 2019, Welfare Reform (Northern Ireland) Order 2015 (Part 5), The Personal Independence Payment Regulations (Northern Ireland) 2016, The Personal Independence Payment (Transitional Provisions) Regulations (Northern Ireland) 2016 and Personal Independence Payment (Transitional Provisions) (Amendment) Regulations (Northern Ireland) 2019; (e) Carer's Allowance Supplement (The Social Security (Scotland) Act 2018); (f) Young Carer's Grant (The Carer's Assistance (Young Carer Grants) (Scotland) Regulations 2020 (as amended)). (ii) MEMBER STATES AUSTRIA (a) Federal Long-term care allowance Act (Bundespflegegeldgesetz, BPGG), original version BGBl. no. 110/1993, last amendment BGBl- I no. 100/2016 (b) Regulation on the staging of the Federal long-term care allowance (Einstufungsverordnung zum Bundespflegegeldgesetz (EinstV)): (c) Regulation of the Federal minister for Labour, Social affairs and Consumer protection on needs assessments of care for children and young people in accordance with the Federal Nursing Care Act. (Bundespflegegeldgesetz, Kinder-EinstV) (d) Numerous applicable statutory bases, e.g. Agreement between the Federal Government and the Länder on joint measures for persons in need of care. Social Assistance Acts and Disability Acts of the Länder. (e) Care Fund Law (Pflegefondsgesetz, PFG), Original version: Official Journal (BGBI. I) No. 57/2011. (f) Care Services Statistics Ordinance 2012 (Pflegedienstleistungsstatistik-Verordnung 2012) (g) Support for the 24-hour care: Federal Long-term care allowance Act (Bundespflegegeldgesetz, BPGG): (h) Guidelines for the support of the 24-hour care (§ 21b of the Federal Long-term care allowance Act (Bundespflegegeldgesetz)) (i) Guidelines for granting benefits to support caring family members (§ 21a of the Federal Long-term care allowance Act (Bundespflegegeldgesetz)) (j) Care recourse interdiction (k) Federal Act on a specific supplement due to the abolition of access to funds when housing people in inpatient care facilities (l) Federal Act on a specific supplement due to the abolition of access to funds when housing people in inpatient care facilities for 2019 and 2020, BGBl. I No 95/2019. BELGIUM (a) Health Care and Sickness Benefit Compulsory Insurance Act (Loi relative à l'assurance obligatoire soins de santé et indemnités/Wet betreffende de verplichte verzekering voor geneeskundige verzorging en uitkeringen), coordinated on 14 July 1994 (b) Act of 27 February 1987 on allowances for persons with disabilities (Loi relative aux allocations aux personnes handicapées/Wet betreffende de tegemoetkomingen aan gehandicapten). (c) Flemish social protection (Vlaamse sociale bescherming): Decree of the Flemish Parliament of 18 May 2018 on the organisation of Flemish social protection (Decreet houdende Vlaamse sociale bescherming/) and Orders of the Flemish government of 30 November 2018. (d) Walloon Code for Social Action and Health (Code wallon de l'Action sociale et de la Santé), decretal part. Part 1, book IIIter, instituted by Decree of 8 November 2018 (e) Walloon Regulatory Code for Social Action and Health, part I/1 instituted by Walloon Government Decree of 21 December 2018 (f) Decree of 13 December 2018 on offers to elderly or dependent persons as well as on palliative care (Dekret über die Angebote für Senioren und Personen mit Unterstützungsbedarf sowie über die Palliativpflege) (g) Decree of 4 June 2007 on psychiatric nursing homes (Dekret über die psychiatrischen Pflegewohnheime) (h) Government Decree of 20 June 2017 on mobility aids (Erlass über die Mobilitätshilfen) (i) Decree of 13 December 2016 on the establishment of a German Community Office for self-determined life (Dekret zur Schaffung einer Dienststelle der Deutschsprachigen Gemeinschaft für selbstbestimmtes Leben) (j) Royal Decree of 5 March 1990 on the allowance for assistance to the elderly (Arrêté royal du 5 mars 1990 relatif à l'allocation pour l'aide aux personnes âgées) (k) Government Decree of 19 December 2019 on transitional arrangements relating to the procedure for obtaining a prior authorization or an approval for the coverage or the sharing of costs of long-term rehabilitation abroad (Erlass der Regierung zur übergansweisen Regelung des Verfahrens zur Erlangung einer Vorabgeehmigung oder Zustimmung zwecks Kostenübernahme oder Kostenbeteiligung für eine Langzeitrehabilitation im Ausland). (l) Order of 21 December 2018 on Brussels health insurance bodies in the field of health care and assistance to people (Ordonnance du 21 décembre 2018 relative aux organismes assureurs bruxellois dans le domaine des soins de santé et de l'aide aux personnes) (m) Cooperation between federated entities: (n) Cooperation agreement of 31 December 2018 between the Flemish Community, the Walloon Region, the French Community Commission, the Joint Community Commission and the German-speaking Community concerning mobility aids (o) Cooperation agreement of 31 December 2018 between the Flemish Community, the Walloon Region, the French Community, the Joint Community Commission, the French Community Commission and the German-speaking Community concerning the financing of care when using care institutions located outside the limits of the federated entity. BULGARIA (a) Social Insurance Code (Кодекс за социално осигуряване), 1999 title amended 2003. (b) Law on Social Assistance (Закон за социално подпомагане), 1998. (c) Regulation on the Implementation of the Law on Social Assistance (Правилник за прилагане на Закона за социално подпомагане), 1998. (d) Law on Integration of People with Disabilities 2019 (Закон за хората с увреждания), 2019. (e) Personal Assistance Act 2019 (Закон за личната помощ) 2019 which entered into force on 1 September 2019. (f) Regulation on the Implementation of the Law on Integration of People with Disabilities (Правилник за прилагане на Закона за интеграция на хората с увреждания), 2004. (g) Ordinance on the medical expertise (Наредба за медицинската експертиза) 2010. (h) Tariff of the Fees for Social Services Financed by the State Budget (Тарифа за таксите за социални услуги, финансирани от държавния бюджет), 2003. CROATIA (a) Social Welfare Act (Zakon o socijalnoj skrbi) of 2013, OJ no. 157/13, 152/14, 99/15, 52/16, 16/17, 130/17 and 98/19) (b) Foster Families Act (Zakon o udomiteljstvu) OJ no. 90/11 and 78/12, as amended. (c) Ordinance on minimum requirements for delivery of social services (Pravilnik o minimalnim uvjetima za pružanje socijalnih usluga) of 2014, OJ no 40/14 and 66/15. (d) Ordinance on participation and method of payment of beneficiaries in the maintenance costs of accommodation outside the family (Pravilnik o sudjelovanju i načinu plaćanja korisnika I drugih obveznika uzdržavanja u troškovima smještaja izvan vlastite obitelji) of 1998, OJ no. 112/98 and 05/02, as amended. (e) Ordinance on the content and manner of keeping records of individuals who are professionally engaged in social services delivery as a profession (Pravilnik o sadržaju I načinu vođenja evidencije fizičkih osoba koje profesionalno pružaju socijalne usluge) of 2015, OJ no. 66/15. CYPRUS (a) Social Welfare Services (Υπηρεσίες Κοινωνικής Ευημερίας): (b) The Guaranteed Minimum Income and in General the Social Benefits (Emergency Needs and Care Needs) Regulations and Decrees as they are amended or superseded. Homes for the Elderly and Disabled Persons Laws (Οι περί Στεγών για Ηλικιωμένους και Αναπήρους Νόμοι) of 1991 - 2011.[L. 222/91 and L. 65(I)/2011]. (c) Adult Day-Care Centres Laws (Οι περί Κέντρων Ενηλίκων Νόμοι)(L. 38(Ι)/1997 and L.64(Ι)/2011). (d) State Aid Scheme, under the Regulation 360/2012 for the provision of services of general economic interest (De minimis) [Σχέδιο Κρατικών Ενισχύσεων ‘Ησσονος Σημασίας, βαση του Κανονισμού 360/2012 για την παροχή υπηρεσιών γενικού οικονομικού συμφέροντος]. (e) Welfare Benefits Administration Service (Υπηρεσία Διαχείρισης Επιδομάτων Πρόνοιας): (f) The Guaranteed Minimum Income and generally for Welfare Benefits Law of 2014 as it is amended or superseded. (g) The Guaranteed Minimum Income and generally for Welfare Benefits Regulations and Decrees as they are amended or superseded. CZECH REPUBLIC (a) Act. No. 108/2006 on social services (Zákon o sociálních službách). (b) Act No. 372/2011 on Health Services (Zákon o zdravotních službách). (c) Act No. 48/1997 on Public Health Insurance (Zákon o veřejném zdravotním pojištění). DENMARK (a) Consolidated Act No 988 of 17 August 2017 on Social Services (om social service). (b) Consolidated Act No 119 of 1 February 2019 on Social Housing (om almene boliger). ESTONIA Social Welfare Act (Sotsiaalhoolekande seadus) 2016. FINLAND (a) Services and Assistance for the Disabled Act (Laki vammaisuuden perusteella järjestettävistä palveluista ja tukitoimista) of 3 April 1987. (b) Act on Supporting the Functional Capacity of the Ageing Population and on Social and Health Care Services for Older People (Laki ikääntyneen väestön toimintakyvyn tukemisesta sekä iäkkäiden sosiaali- ja terveyspalveluista) of 28 December 2012. (c) Social Welfare Act (Sosiaalihuoltolaki) of 30 December 2014. (d) Health Care Act (Terveydenhuoltolaki) of 30 December 2010. (e) Primary Health Care Act (Kansanterveyslaki) of 28 January 1972. (f) Act on Informal Care Support (Laki omaishoidon tuesta) of 2 December 2005. (g) Family Care Act (Perhehoitolaki) of 20 March 2015. FRANCE (a) Supplement for a third party (majoration pour tierce personne, MTP): Articles L. 341-4 and L. 355-1 of the Social Security Code (Code de la sécurité sociale). (b) Supplementary benefit for recourse to a third party (prestation complémentaire pour recours à tierce personne): Article L. 434-2 of the Social Security Code. (c) Special education supplement for a disabled child (complément d'allocation d'éducation de l'enfant handicapé): Article L. 541-1 of the Social Security Code. (d) Disability compensation allowance (prestation de compensation du handicap, PCH): Articles L. 245-1 to L. 245-14 of the Social action and Family Code (Code de l'action sociale et des familles). (e) Allowance for loss of autonomy (allocation personnalisée d'autonomie, APA): Articles L. 232-1 to L. 232-28 of the Social action and Family Code (Code de l'action sociale et des familles). GERMANY (a) Long-term care insurance (Pflegeversicherung): (b) Social long-term care insurance for persons insured under statutory sickness insurance and private compulsory long-term care insurance for persons insured under private sickness insurance: Social CodeSozialgesetzbuch, Book XI (SGB XI), last amended by Article 2 of the Act of 21 December 2019 (BGBl. I p. 2913). GREECE (a) Law No. 1140/1981, as amended. (b) Legislative Decree No. 162/73 and Joint Ministerial Decision No. Π4β/5814/1997. (c) Ministerial Decision No. Π1γ/ΑΓΠ/οικ.14963 of 9 October 2001. (d) Law No. 4025/2011. (e) Law No. 4109/2013. (f) Law No. 4199/2013 art. 127. (g) Law No. 4368/2016 art. 334. (h) Law No. 4483/2017 art. 153. (i) Law No. 498/1-11-2018, art. 28, 30 and 31, for the "Unified Health Benefits Regulation" of the National Service Provider Organization Health (EOPYY). HUNGARY (a) Long-term care services providing personal social care (social services): (b) Act III of 1993 on Social Administration and Social Assistance (törvény a szociális igazgatásról és szociális ellátásokról) supplemented by Government and Ministerial decrees. IRELAND (a) Health Act 1970 (No. 1 of 1970). (b) Nursing Homes Support Scheme Act 2009 (No. 15 of 2009). (c) Social Welfare Consolidation Act 2005: (d) Constant Attendance Allowance; (e) Carer's Benefit; (f) Carer's Allowance; (g) Carer's Support Grant; (h) Domiciliary Care Allowance. ITALY (a) Law No. 118 of 30 March 1971 on civilian invalidity benefits (Legge 30 Marzo 1971, n. 118 - Conversione in Legge del D.L. 30 gennaio 1971, n. 5 e nuove norme in favore dei mutilati ed invalidi civili). (b) Law No. 18 of 11 February 1980 on Constant attendance allowance (Legge 11 Febbraio 1980, n. 18 - Indennità di accompagnamento agli invalidi civili totalmente inabili). (c) Law No. 104 of 5 February 1992, Article 33 (Framework law on disability) (Legge 5 Febbraio 1992, n. 104 - Legge-quadro per l'assistenza, l'integrazione sociale e i diritti delle persone handicappate). (d) Legislative Decree No. 112 of 31 March 1998 on the transfer of legislative tasks and administrative competences from the State to the Regions and local entities (Decreto Legislativo 31 Marzo 1998, n. 112 - Conferimento di funzioni e compiti amministrativi dello Stato alle regioni ed agli enti locali, in attuazione del capo I della Legge 15 Marzo 1997, n. 59). (e) Regulation (CE) 883/04 on social security coordination of the European Parliament and Council (Regolamento (CE) 883 del 29 aprile 2004 del Parlamento Europeo e del Consiglio, relativo al coordinamento dei sistemi di sicurezza sociale - SNCB – art 70 and Annex X). (f) Law No. 183 of 4 November 2010, Article 24, modifying the rules regarding the permits for the assistance to disabled persons in difficult situations (Legge n. 183 del 4 Novembre 2010, art. 24 - Modifiche alla disciplina in materia di permessi per l'assistenza a portatori di handicap in situazione di gravità). (g) Law No. 147 of 27 December 2013 containing provisions for drawing up the annual and pluri-annual budget of the State – Stability Law 2014 (Disposizioni per la formazione del bilancio annuale e pluriennale dello Stato - Legge di stabilità 2014). LATVIA (a) Law on Social Services and Social Assistance (Sociālo pakalpojumu un sociālās palīdzības likums) 31/10/2002. (b) Medical Treatment Law (Ārstniecības likums) 12/06/1997. (c) Law on Patient Rights (Pacientu tiesību likums) 30/12/2009 (d) Regulations of the Cabinet of Ministers No. 555 on Health care organisation and payment procedure (Ministru kabineta 2018. gada 28.augusta noteikumi Nr.555 “Veselības aprūpes pakalpojumu organizēšanas un samaksas kārtība”) 28/08/2018. (e) Regulations of the Cabinet of Ministers No. 275 on Procedures for Payment of Social Care and Social Rehabilitation Services and the Procedures for Covering Service Costs from a Local Government Budget (Ministru kabineta 2003.gada 27.maija noteikumi Nr.275 „Sociālās aprūpes un sociālās rehabilitācijas pakalpojumu samaksas kārtība un kārtība, kādā pakalpojuma izmaksas tiek segtas no pašvaldības budžeta”) 27/05/2003. (f) Regulations of the Cabinet of Ministers No. 138 on Receiving of Social Services and Social Assistance (Ministru kabineta 2019.gada 2.aprīļa noteikumi Nr 138 "Noteiku mi par sociālo pakalpojumu un sociālās palīdzības saņemšanu") 02/04/2019. LITHUANIA (a) Law on Target compensations (Tikslinių kompensacijų įstatymas) of 29 June 2016 (No. XII-2507). (b) Law on Social Services (Socialinių paslaugų įstatymas) of 19 January 2006 (No. X-493). (c) Law on Health Insurance (Sveikatos draudimo įstatymas) of 21 May 1996 (No I-1343). (d) Law on Healthcare system (Sveikatos sistemos įstatymas) of 19 July 1994 (No I-552). (e) Law on Health Care Institutions (Sveikatos priežiūros įstaigų įstatymas) of 6 June 1996 (No. I-1367). LUXEMBOURG Law of 19 June 1998 introducing the dependency insurance, amended by the Law of 23 December 2005 and the Law of 29 August 2017. MALTA (a) Social Security Act (Att dwar is-Sigurta' Socjali) (Cap. 318). (b) Subsidiary Legislation 318.19: State-Owned Institutions and Hostels Rates Regulations (Regolamenti dwar it-Trasferiment ta' Fondi għal Hostels Statali Indikati). (c) Subsidiary Legislation 318.17: Transfer of Funds (Government Financed Beds) Regulations (Regolamenti dwar it-Trasferiment ta' Fondi għal Sodod Iffinanzjati mill-Gvern). (d) Subsidiary Legislation 318.13: State Financed Residential Services Rates Regulations (Regolamenti dwar Rati għal Servizzi Residenzjali Finanzjali mill-Istat). THE NETHERLANDS Long term care act (Wet langdurige zorg (WLZ)), Law of 3 December 2014. POLAND (a) Law on Health Care Services financed from Public Means (Ustawa o świadczeniach opieki zdrowotnej finansowanych ze środków publicznych) of 27 August 2004. (b) Law on Social Assistance (Ustawa o pomocy społecznej) of 12 March 2004. (c) Law on Family Benefits (Ustawa o świadczeniach rodzinnych) of 28 November 2003. (d) Law on Social Pension (Ustawa o rencie socjalnej) of 27 June 2003. (e) Law on Social Insurance Fund Pensions (Ustawa o emeryturach i rentach z Funduszu Ubezpieczeń Społecznych) of 17 December 1998. (f) Law on Vocational and Social Rehabilitation and Employment of Disabled Persons (Ustawa o rehabilitacji zawodowej i społecznej oraz zatrudnianiu osób niepełnosprawnych) of 27 August 1997. (g) Law on support for pregnant women and their families "For life" (Ustawa o wsparciu kobiet w ciąży i rodzin “Za życiem”) of 4 November 2016. (h) Law on supplementary benefit for persons unable to live independently (Ustawa o świadczeniu uzupełniającym dla osób niezdolnych do samodzielnej egzystencji) of 31 July 2019. PORTUGAL (a) Social insurance and guaranteeing sufficient resources: (b) Statutory Decree 265/99 of 14 July 1999 on the long-term care supplement (complemento por dependência), as amended on several occasions. (c) Act 90/2009 of 31 August 2009 on the special protection system in case of disability (regime especial de proteção na invalidez), re-published in consolidated version by Statutory Decree 246/2015 of 20 October 2015, amended. (d) Social security system and National Health Service: (e) Statutory Decree 101/06 of 6 June 2006 on the National network of integrated continuing care (rede de cuidados continuados integrados), re-published in a consolidated version in Statutory Decree 136/2015 of 28 July 2015. (f) Decree-Law n° 8/2010 of 28 January 2010, amended and republished by Decree-Law n° 22/2011 of 10 February 2011 on the creation of units and teams for integrated continuous care in mental health (unidades e equipas de cuidados continuados integrados de saúde mental). (g) Decree n° 343/.2015 of 12 October 2015 on standards governing hospital and ambulatory paediatric care as well as the discharge management teams and the paediatric care teams within the framework of the national network of long-term integrated care (condições de instalação e funcionamento das unidades de internamento de cuidados integrados pediátricos e de ambulatório pediátricas, bem como as condições a que devem obedecer as equipas de gestão de altas e as equipas de cuidados continuados integrados destinadas a cuidados pediátricos da Rede Nacional de Cuidados Continuados Integrados). (h) Law n° 6/2009 of 6 September on the status of informal carer (Estatuto do cuidador informal). ROMANIA (a) Law 17 of 6 March 2000 on Social Assistance of Senior Persons (Legea privind asistența socială a persoanelor vârstnice), with subsequent amendments. (b) Law 448 of 6 December 2006 on Protection and Promotion of the Rights of Persons with Disability (Legea privind protecția și promovarea drepturilor persoanelor cu handicap), with subsequent amendments. (c) Social Assistance Law (Legea asistenței sociale) No. 292 of 20 December 2011. SLOVAKIA (a) Law on Social Services (Zákon o sociálnych službách) No. 448/2008. (b) Law on Financial Benefits for Compensation of Disabled Persons (Zákon o peňažných príspevkoch na kompenzáciu ťažkého zdravotného postihnutia) No. 447/2008. (c) Law on Health Care and Services Related to Health Care (Zákon o zdravotnej starostlivosti a službách súvisiacich s poskytovaním zdravotnej starostlivosti) No. 576/2004. (d) Law on Health Care Providers, Medical Workers and Professional Medical Associations (Zákon o poskytovateľoch zdravotnej starostlivosti, zdravotníckych pracovníkoch a stavovských organizáciách v zdravotníctve) No. 578/2004. (e) Law on Subsistence Minimum (Zákon o životnom minime) No. 601/2003. (f) Law on Family (Zákon o rodine) No. 36/2005 (g) Law on Social and legal protection of children and social guardianship (Zákon o sociálno-právnej ochrane detí a sociálnej kuratele) No. 305/2005 (h) Law on Social Work (Zákon o sociálnej práci) No. 219/2014. SLOVENIA No specific law related to long-term care. Long-term care benefits are included in the following acts: (a) Pension and Disability Insurance Act (Zakon o pokojninskem in invalidskem zavarovanju) (Official Gazette of the Republic of Slovenia, no. 96/2012, and subsequent amendments). (b) Financial Social Assistance Act (Zakon o socialno vartsvenih prejemkih) (Official Gazette of the Republic of Slovenia, no. 61/2010, and subsequent amendments). (c) Exercise of Rights to Public Funds Act (Zakon o uveljavljanju pravic iz javnih sredstev) (Official Gazette of the Republic of Slovenia, no. 62/2010, and subsequent amendments). (d) Social Protection Act (Zakon o socialnem varstvu) (Official Gazette of the Republic of Slovenia, no. 3/2004 – official consolidated text, and subsequent amendments). (e) Parental Care and Family Benefits Act (Zakon o starševskem varstvu in družinskih prejemkih) (Official Gazette of the Republic of Slovenia, no. 110/2006 – official consolidated text, and subsequent amendments). (f) Mentally and Physically Handicapped Persons Act (Zakon o družbenem varstvu duševno in telesno prizadetih oseb) (Official Gazette of the Republic of Slovenia, no. 41/83, and subsequent amendments). (g) Health Care and Health Insurance Act (Zakon o zdravstvenem varstvu in zdravstvenem zavarovanju) (Official Gazette of the Republic of Slovenia, no. 72/2006 – official consolidated text, and subsequent amendments). (h) War Veterans Act (Zakon o vojnih veteranih) (Official Gazette of the Republic of Slovenia, no 59/06 official consolidated text, and subsequent amendments) (i) War Disability Act (Zakon o vojnih invalidih) (Official Gazette of the Republic of Slovenia, no 63/59 official consolidated text, and subsequent amendments) (j) Fiscal Balance Act (Zakon za uravnoteženje javnih finance (ZUJF)) (Official Gazette of the Republic of Slovenia, no. 40/2012, and subsequent amendments). (k) Act Regulating Adjustments of Transfers to Individuals and Households in the Republic of Slovenia (Zakon o usklajevanju transferjev posameznikom in gospodinjstvom v Republiki Sloveniji) (Official Gazette of the Republic of Slovenia, no. 114/2006 – official consolidated text, and subsequent amendments). SPAIN (a) Law No. 39/2006 on the Promotion of Personal Autonomy and Assistance to persons in situations of dependence of 14 December 2006, as amended. (b) Ministerial Order of 15 April 1969. (c) Royal Decree No. 1300/95 of 21 July 1995, as amended. (d) Royal Decree No. 1647/97 of 31 October 1997, as amended. SWEDEN (a) Social Services Act (Socialtjänstlagen (2001:453)) of 2001. (b) The Health Care Act (Hälso- och sjukvårdslag (2017:30)) of 2017. PART 3 PAYMENTS WHICH ARE CONNECTED TO A BRANCH OF SOCIAL SECURITY LISTED IN ARTICLE SSC.3(1) OF THIS PROTOCOL AND WHICH ARE PAID TO MEET EXPENSES FOR HEATING IN COLD WEATHER (Point (f) of Article SSC.3(4) of this Protocol) (i) UNITED KINGDOM Winter Fuel Payment (Social Security Contributions and Benefits Act 1992, Social Fund Winter Fuel Payment Regulations 2000, Social Security Contributions and Benefits (Northern Ireland) Act 1992 and Social Fund Winter Fuel Payment Regulations (Northern Ireland) 2000). (ii) MEMBER STATES DENMARK (a) Act on Social and state pensions, LBK no. 983 of 23/09/2019 (b) Regulations on social and state pensions, BEK no. 1602 of 27/12/2019. ANNEX SSC-2 RESTRICTION OF RIGHTS TO BENEFITS IN KIND FOR MEMBERS OF THE FAMILY OF A FRONTIER WORKER (referred to in Article SSC.16(2) of this Protocol) CROATIA DENMARK IRELAND FINLAND SWEDEN UNITED KINGDOM ANNEX SSC-3 MORE RIGHTS FOR PENSIONERS RETURNING TO THE COMPETENT STATE (Article SSC.25(2) of this Protocol) AUSTRIA BELGIUM BULGARIA CYPRUS CZECH REPUBLIC FRANCE GERMANY GREECE HUNGARY LUXEMBOURG THE NETHERLANDS POLAND SLOVENIA SPAIN SWEDEN ANNEX SSC-4 CASES IN WHICH THE PRO RATA CALCULATION SHALL BE WAIVED OR SHALL NOT APPLY (Article SSC.47(4) and (5) of this Protocol) PART 1 CASES IN WHICH THE PRO RATA CALCULATION SHALL BE WAIVED PURSUANT TO ARTICLE SSC.47(4) AUSTRIA (a) All applications for benefits under the Federal Act of 9 September 1955 on General Social Insurance – ASVG, the Federal Act of 11 October 1978 on social insurance for self-employed persons engaged in trade and commerce – GSVG, the Federal Act of 11 October 1978 on social insurance for self-employed farmers – BSVG and the Federal Act of 30 November 1978 on social insurance for the self-employed in the liberal professions (FSVG); (b) All applications for survivors' pensions based on a pension account pursuant to the General Pensions Act (APG) of 18 November 2004, with the exception of cases under Part 2; (c) All applications for survivors' pensions of the Austrian Provincial Chambers of Physicians (Landesärztekammer) based on basic provision (basic and any supplementary benefit, or basic pension); (d) All applications for survivors' support from the pension fund of the Austrian Chamber of Veterinary Surgeons; (e) All applications for benefits from widows and orphans pensions according to the statutes of the welfare institutions of the Austrian bar associations, Part A; (f) All applications for benefits under the Notary Insurance Act of 3 February 1972 – NVG 1972. CYPRUS All applications for old age, widow's and widower's pensions. DENMARK All applications for pensions referred to in the law on social pensions, except for pensions mentioned in Annex SSC-5 to this Protocol. IRELAND All applications for state pension (transition), state pension (contributory), widow's (contributory) pension and widower's (contributory) pension. LATVIA All applications for survivor's pensions (Law on State pensions of 1 January 1996; Law on State funded pensions of 1 July 2001). LITHUANIA All applications for State social insurance survivor's pensions calculated on the basis of the basic amount of survivor's pension (Law on State Social Insurance Pensions). NETHERLANDS All applications for old-age pensions under the law on general old-age insurance (AOW). POLAND All applications for old-age under the defined benefits scheme and survivors' pensions, except for the cases where the totalised periods of insurance completed under the legislation of more than one country are equal to or longer than 20 years for women and 25 years for men but the national periods of insurance are inferior to these limits (and not less than 15 years for women and 20 years for men), and the calculation is made under Articles 27 and 28 of the Act of 17 December 1998 (O.J. 2015, item 748). PORTUGAL All applications for old-age and survivors' pension claims, except for the cases where the totalised periods of insurance completed under the legislation of more than one country are equal to or longer than 21 calendar years but the national periods of insurance are equal or inferior to 20 years, and the calculation is made under Articles 32 and 33 of Decree-Law No 187/2007 of 10 May 2007. SLOVAKIA (a) All applications for survivors' pension (widow's pension, widower's and orphan's pension) calculated according to the legislation in force before 1 January 2004, the amount of which is derived from a pension formerly paid to the deceased; (b) All applications for pensions calculated pursuant to Act No 461/2003 Coll. on social security as amended. SWEDEN (a) Applications for an old-age pension in the form of a guaranteed pension (Chapters 66 and 67 of the Social Insurance Code). (b) Applications for an old-age pension in the form of a supplementary pension (Chapter 63 of the Social Insurance Code). UNITED KINGDOM All applications for retirement pension, state pension pursuant to Part 1 of the Pensions Act 2014, widows' and bereavement benefits, with the exception of those for which during a tax year beginning on or after 6 April 1975: (i) the party concerned had completed periods of insurance, employment or residence under the legislation of the United Kingdom and a Member State; and one (or more) of the tax years was not considered a qualifying year within the meaning of the legislation of the United Kingdom; (ii) the periods of insurance completed under the legislation in force in the United Kingdom for the periods prior to 5 July 1948 would be taken into account for the purposes of point (b) of Article SSC.47(1) of this Protocol by application of the periods of insurance, employment or residence under the legislation of a Member State. All applications for additional pension pursuant to the Social Security Contributions and Benefits Act 1992, section 44, and the Social Security Contributions and Benefits (Northern Ireland) Act 1992, section 44. PART 2 CASES IN WHICH ARTICLE SSC.47(5) APPLIES AUSTRIA (a) Old-age pensions and survivor's pensions derived thereof based on a pension account pursuant to the General Pensions Act (APG) of 18 November 2004; (b) Compulsory allowances under Article 41 of the Federal Law of 28 December 2001, BGBl I Nr. 154 on the general salary fund of Austrian pharmacists (Pharmazeutische Gehaltskasse für Österreich); (c) Retirement and early retirement pensions of the Austrian Provincial Chambers of Physicians based on basic provision (basic and any supplementary benefit, or basic pension), and all pension benefits of the Austrian Provincial Chambers of Physicians based on additional provision (additional or individual pension); (d) Old-age support from the pension fund of the Austrian Chamber of Veterinary Surgeons; (e) Benefits according to the statutes of the welfare institutions of the Austrian bar associations, Parts A and B, with the exception of applications for benefits from widows' and orphans' pensions according to the statutes of the welfare institutions of the Austrian bar associations, Part A; (f) Benefits by the welfare institutions of the Federal Chamber of Architects and Consulting Engineers under the Austrian Civil Engineers' Chamber Act (Ziviltechnikerkammergesetz) 1993 and the statutes of the welfare institutions, with the exception of benefits on grounds of survivors' benefits deriving from the last-named benefits; (g) Benefits according to the statute of the welfare institution of the Federal Chamber of Professional Accountants and Tax Advisors under the Austrian Professional Accountants and Tax Advisors' Act (Wirtschaftstreuhandberufsgesetz). BULGARIA Old age pensions from the Supplementary Compulsory Pension Insurance, under Part II, Title II, of the Social Insurance Code. CROATIA Pensions from the compulsory insurance scheme based on the individual capitalised savings according to the Compulsory and Voluntary Pension Funds Act (OG 49/99, as amended) and the Act on Pension Insurance Companies and Payment of Pensions Based on Individual Capitalised Savings (OG 106/99, as amended), except in the cases provided by Articles 47 and 48 of the Compulsory and Voluntary Pension Funds Act and survivor's pension). CZECH REPUBLIC Pensions paid from the Second Pillar scheme established by Act No 426/2011 Coll., on pension savings. DENMARK (a) Personal pensions; (b) Benefits in the event of death (accrued based on contributions to Arbejdsmarkedets Tillægspension related to the time before 1 January 2002); (c) Benefits in the event of death (accrued based on contributions to Arbejdsmarkedets Tillægspension related to the time after 1 January 2002) referred to in the Consolidated Act on Labour Market Supplementary Pension (Arbejdsmarkedets Tillægspension) 942:2009. ESTONIA Mandatory funded old-age pension scheme. FRANCE Basic or supplementary schemes in which old-age benefits are calculated on the basis of retirement points. HUNGARY Pension benefits based on membership of private pension funds. LATVIA Old-age pensions (Law on State pensions of 1 January 1996; Law on State funded pensions of 1 July 2001). POLAND Old-age pensions under the defined contribution scheme. PORTUGAL Supplementary pensions granted pursuant to Decree-Law No 26/2008 of 22 February 2008 (public capitalisation scheme). SLOVAKIA Mandatory old-age pension saving. SLOVENIA Pension from compulsory supplementary pension insurance. SWEDEN Old-age pension in the form of an income pension and a premium pension (Chapters 62 and 64 of the Social Insurance Code). UNITED KINGDOM Graduated retirement benefits paid pursuant to the National Insurance Act 1965, sections 36 and 37, and the National Insurance Act (Northern Ireland) 1966, sections 35 and 36. ANNEX SSC-5 BENEFITS AND AGREEMENTS WHICH ALLOW THE APPLICATION OF ARTICLE SSC.49 I. Benefits referred to in point (a) of Article SSC.49(2) of this Protocol, the amount of which is independent of the length of periods of insurance or residence completed DENMARK The full Danish national old-age pension acquired after 10 years' residence by persons who will have been awarded a pension by 1 October 1989 FINLAND National pensions and spouse's pensions determined according to the transitional rules and awarded prior to 1 January 1994 (Act on Enforcement of the National Pensions Act, 569/2007) The additional amount of child's pension when calculating independent benefit according to the National Pension Act (the National Pension Act, 568/2007) FRANCE Widower's or widow's invalidity pension under the general social security system or under the agricultural workers scheme where it is calculated on the basis of the deceased spouse's invalidity pension settled in accordance with point (a) of Article SSC.47(1). GREECE Benefits under Law No 4169/1961 relating to the agricultural insurance scheme (OGA) NETHERLANDS General Surviving Relatives Act of 21 December 1995 (ANW) The Work and Income according to Labour Capacity Act of 10 November 2005 (WIA) SPAIN Survivors' pensions granted under the general and special schemes, with the exception of the Special Scheme for Civil Servants SWEDEN Income-related sickness compensation and income-related activity compensation (Chapter 34 of the Social Insurance Code) Guaranteed pension and guaranteed compensation which replaced the full state pensions provided under the legislation on the state pension which applied before 1 January 1993, and the full state pension awarded under the transitional rules of the legislation applying from that date II. Benefits referred to in point (b) of Article SSC.49(2) of this Protocol, the amount of which is determined by reference to a credited period deemed to have been completed between the date on which the risk materialised and a later date FINLAND Employment pensions for which account is taken of future periods according to the national legislation GERMANY Survivors' pensions, for which account is taken of a supplementary period Old-age pensions, for which account is taken of a supplementary period already acquired ITALY Italian pensions for total incapacity for work (inabilità) LATVIA Survivors' pension calculated on the basis of assumed insurance periods (Article 23(8) of the Law on State Pensions of 1 January 1996) LITHUANIA (a) State social insurance work incapacity pensions, paid under the Law on State Social Insurance Pensions (b) State social insurance survivors' and orphans' pensions, calculated on the basis of the work incapacity pension of the deceased under the Law on State Social Insurance Pensions LUXEMBOURG Survivors' pensions SLOVAKIA Slovak survivors' pension derived from the invalidity pension. SPAIN The pensions for retirement under the Special Scheme for Civil Servants due under Title I of the consolidated text of the Law on State Pensioners if at the time of materialisation of the risk the beneficiary was an active civil servant or treated as such; death and survivors' (widows'/widowers', orphans' and parents') pensions due under Title I of the consolidated text of the Law on State Pensioners if at the time of death the civil servant was active or treated as such SWEDEN Sickness compensation and activity compensation in the form of guarantee compensation (Chapter 35 of the Social Insurance Code) Survivors' pension calculated on the basis of credited insurance periods (Chapters 76-85 of the Social Insurance Code) III. Agreements referred to in point (b)(i) of Article SSC.49(2) of this Protocol intended to prevent the same credited period being taken into account two or more times: The Social Security Agreement of 28 April 1997 between the Republic of Finland and the Federal Republic of Germany The Social Security Agreement of 10 November 2000 between the Republic of Finland and the Grand Duchy of Luxembourg Nordic Convention on social security of 18 August 2003. ANNEX SSC-6 SPECIAL PROVISIONS FOR THE APPLICATION OF THE LEGISLATION OF THE MEMBER STATES AND OF THE UNITED KINGDOM (Article SSC.3(2), Article SSC.51(1) and Article SSC.66) AUSTRIA 1. For the purpose of acquiring periods in the pension insurance, attendance at a school or comparable educational establishment in another State shall be regarded as equivalent to attendance at a school or educational establishment pursuant to Articles 227(1)(1) and 228(1)(3) of the Allgemeines Sozialversicherungsgesetz (ASVG) (General Social Security Act), Article 116(7) of the Gewerbliches Sozialversicherungsgesetz (GSVG) (Federal Act on Social Insurance for Persons engaged in Trade and Commerce) and Article 107(7) of the Bauern-Sozialversicherungsgesetz (BSVG) (Social Security Act for Farmers), when the person concerned was subject at some time to Austrian legislation on the grounds that he pursued an activity as an employed or self-employed person, and the special contributions provided for under Article 227(3) of the ASVG, Article 116(9) of the GSVG and Article 107(9) of the BSGV for the purchase of such periods of education, are paid. 2. For the calculation of the pro rata benefit referred to in point (b) of Article SSC.47(1) of this Protocol, special increments for contributions for supplementary insurance and the miners' supplementary benefit under Austrian legislation shall be disregarded. In those cases the pro rata benefit calculated without those contributions shall, if appropriate, be increased by unreduced special increments for contributions for supplementary insurance and the miners' supplementary benefit. 3. Where pursuant to Article SSC.7 of this Protocol substitute periods under an Austrian pension insurance scheme have been completed but cannot form a basis for calculation pursuant to Articles 238 and 239 of the ASVG, Articles 122 and 123 of the GSVG and Articles 113 and 114 of the BSVG, the calculation basis for periods of childcare pursuant to Article 239 of the ASVG, Article 123 of the GSVG and Article 114 of the BSVG shall be used. BULGARIA Article 33(1) of the Bulgarian Health Insurance Act applies to all persons for whom Bulgaria is the competent Member State under Chapter 1 of Title III of this Protocol. CYPRUS For the purpose of applying the provisions of Articles SSC.7, SSC.46 and SSC.56 of this Protocol, for any period commencing on or after 6 October 1980, a week of insurance under the legislation of the Republic of Cyprus is determined by dividing the total insurable earnings for the relevant period by the weekly amount of the basic insurable earnings applicable in the relevant contribution year, provided that the number of weeks so determined shall not exceed the number of calendar weeks in the relevant period. CZECH REPUBLIC For the purposes of defining members of the family in accordance with point (s) of Article SSC.1 of this Protocol, "spouse" includes registered partners as defined in the Czech act no. 115/2006 Coll., on registered partnership. DENMARK 1. (a) For the purpose of calculating the pension under the "lov om social pension" (Social Pension Act), periods of activity as an employed or self-employed person completed under Danish legislation by a frontier worker or a worker who has gone to Denmark to do work of a seasonal nature are regarded as periods of residence completed in Denmark by the surviving spouse in so far as, during those periods, the surviving spouse was linked to the abovementioned worker by marriage without separation from bed and board or de facto separation on grounds of incompatibility, and provided that, during those periods, the spouse resided in the territory of another State. For the purposes of this point, "work of a seasonal nature" means work which, being dependent on the succession of the seasons, automatically recurs each year. (b) For the purpose of calculating the pension under the "lov om social pension" (Social Pension Act), periods of activity as an employed or self-employed person completed under Danish legislation before 1 January 1984 by a person to whom point (a) does not apply shall be regarded as periods of residence completed in Denmark by the surviving spouse, in so far as, during those periods, the surviving spouse was linked to that person by marriage without separation from bed and board or de facto separation on grounds of incompatibility, and provided that, during those periods, the spouse resided in the territory of another State. (c) Periods to be taken into account under points (a) and (b) shall not be taken into consideration if they coincide with the periods taken into account for the calculation of the pension due to the person concerned under the legislation on compulsory insurance of another State, or with the periods during which the person concerned received a pension under such legislation. Those periods shall, however, be taken into consideration if the annual amount of the said pension is less than half the basic amount of the social pension. 2. (a) Notwithstanding the provisions of Article SSC.7 of this Protocol, persons who have not been gainfully employed in one or more States are entitled to a Danish social pension only if they have been, or have previously been, permanent residents of Denmark for at least 3 years, subject to the age limits prescribed by Danish legislation. Subject to Article SSC.5 of this Protocol, Article SSC.8 of this Protocol does not apply to a Danish social pension to which entitlement has been acquired by such persons. (b) The provisions referred to in point (a) do not apply to Danish social pension entitlement for the members of the family of persons who are or have been gainfully employed in Denmark, or for students or the members of their families. 3. The temporary benefit for unemployed persons who have been admitted to the ledighedsydelse (flexible job' scheme) (Law No 455 of 10 June 1997) is covered by Chapter 6 of Title III of this Protocol. 4. Where the beneficiary of a Danish social pension is also entitled to a survivor's pension from another State, those pensions for the implementation of Danish legislation shall be regarded as benefits of the same kind within the meaning of Article SSC.48(1), subject to the condition, however, that the person whose periods of insurance or of residence serve as the basis for the calculation of the survivor's pension had also acquired a right to a Danish social pension. ESTONIA For the purpose of calculating parental benefits, periods of employment in States other than Estonia shall be considered to be based on the same average amount of Social Tax as paid during the periods of employment in Estonia with which they are aggregated. If during the reference year the person has been employed only in other States, the calculation of the benefit shall be considered to be based on the average Social Tax paid in Estonia between the reference year and the maternity leave. FINLAND 1. For the purposes of determining entitlement and of calculating the amount of the Finnish national pension under Articles SSC.47, SSC.48 and SSC.49 of this Protocol, pensions acquired under the legislation of another State are treated in the same way as pensions acquired under Finnish legislation. 2. When applying point (b)(i) of Article SSC.47(1) of this Protocol for the purpose of calculating earnings for the credited period under Finnish legislation on earnings-related pensions, where an individual has pension insurance periods based on activity as an employed or self-employed person in another State for part of the reference period under Finnish legislation, the earnings for the credited period shall be equivalent to the sum of earnings obtained during the part of the reference period in Finland, divided by the number of months for which there were insurance periods in Finland during the reference period. FRANCE 1. For persons receiving benefits in kind in France pursuant to Article SSC.15 or SSC.24 of this Protocol who are resident in the French departments of Haut-Rhin, Bas-Rhin or Moselle, benefits in kind provided on behalf of the institution of another State which is responsible for bearing their cost include benefits provided by both the general sickness insurance scheme and the obligatory supplementary local sickness insurance scheme of Alsace-Moselle. 2. French legislation applicable to a person engaged, or formerly engaged, in an activity as an employed or self-employed person for the application of Chapter 5 of Title III of this Protocol includes both the basic old-age insurance scheme(s) and the supplementary retirement scheme(s) to which the person concerned was subject. GERMANY 1. Notwithstanding point (a) of Article SSC.6 of this Protocol and point 1 of Article 5(4) of the Sozialgesetzbuch VI (Volume VI of the Social Code), a person who receives a full old-age pension under the legislation of another State may request to be compulsorily insured under the German pension insurance scheme. 2. Notwithstanding point (a) of Article SSC.6 of this Protocol and Article 7 of the Sozialgesetzbuch VI (Volume VI of the Social Code), a person who is compulsorily insured in another State, or receives an old-age pension under the legislation of another State may join the voluntary insurance scheme in Germany. 3. For the purpose of granting cash benefits under §47(1) of SGB V, §47(1) of SGB VII and §200(2) of the Reichsversicherungsordnung to insured persons who live in another State, German insurance schemes calculate net pay, which is used to assess benefits, as if the insured person lived in Germany, unless the insured person requests an assessment on the basis of the net pay which he actually receives. 4. Nationals of other States whose place of residence or usual abode is outside Germany and who fulfil the general conditions of the German pension insurance scheme may pay voluntary contributions only if they had been voluntarily or compulsorily insured in the German pension insurance scheme at some time previously; this also applies to stateless persons and refugees whose place of residence or usual abode is in another State. 5. The pauschale Anrechnungszeit (fixed credit period) pursuant to Article 253 of the Sozialgesetzbuch VI (Volume VI of the Social Code) shall be determined exclusively with reference to German periods. 6. In cases where the German pension legislation, in force on 31 December 1991, is applicable for the recalculation of a pension, only the German legislation applies for the purposes of crediting German Ersatzzeiten (substitute periods). 7. The German legislation on accidents at work and occupational diseases to be compensated for under the law governing foreign pensions and on benefits for insurance periods which can be credited under the law governing foreign pensions in the territories named in paragraph 1(2)(3) of the Act on affairs of displaced persons and refugees (Bundesvertriebenengesetz) continues to apply within the scope of application of this Protocol, notwithstanding the provisions of paragraph 2 of the Act on foreign pensions (Fremdrentengesetz). 8. For the calculation of the theoretical amount referred to in point (b)(i) of Article SSC.47(1) of this Protocol, in pension schemes for liberal professions, the competent institution shall take as a basis, in respect of each of the years of insurance completed under the legislation of any other State, the average annual pension entitlement acquired during the period of membership of the competent institution through the payment of contributions. GREECE 1. Law No 1469/84 concerning voluntary affiliation to the pension insurance scheme for Greek nationals and foreign nationals of Greek origin is applicable to nationals of other States, stateless persons and refugees, where the persons concerned, regardless of their place of residence or stay, have at some time in the past been compulsorily or voluntarily affiliated to the Greek pension insurance scheme. 2 Notwithstanding point (a) of Article SSC.6 of this Protocol and Article 34 of Law 1140/1981, a person who receives a pension in respect of accidents at work or occupational diseases under the legislation of another State may request to be compulsorily insured under the legislation applied by OGA, to the extent that they pursue an activity falling within the scope of that legislation. IRELAND 1. Notwithstanding Article SSC.19(2) and Article SSC.57 of this Protocol, for the purposes of calculating the prescribed reckonable weekly earnings of an insured person for the grant of sickness or unemployment benefit under Irish legislation, an amount equal to the average weekly wage of employed persons in the relevant prescribed year shall be credited to that insured person in respect of each week of activity as an employed person under the legislation of another State during that prescribed year. MALTA Special provisions for civil servants (a) Solely for the purposes of the application of Articles SSC.43 and SSC.55 of this Protocol, persons employed under the Malta Armed Forces Act (Chapter 220 of the Laws of Malta), the Police Act (Chapter 164 of the Laws of Malta) and the Prisons Act (Chapter 260 of the Laws of Malta) shall be treated as civil servants. (b) Pensions payable under the above Acts and under the Pensions Ordinance (Chapter 93 of the Laws of Malta) shall, solely for the purposes of point (cc) of Article SSC.1 of this Protocol, be considered as "special schemes for civil servants". NETHERLANDS 1. Health care insurance (a) As regards entitlement to benefits in kind under Dutch legislation, persons entitled to benefits in kind for the purpose of the implementation of Chapters 1 and 2 of Title III of this Protocol shall mean: (i) persons who, under Article 2 of the Zorgverzekeringswet (Health Care Insurance Act), are obliged to take out insurance under a health care insurer; and (ii) in so far as they are not already included under point (i), members of the family of active military personnel who are living in another State and persons who are resident in another State and who, under this Protocol, are entitled to health care in their state of residence, the costs being borne by the Netherlands. (b) The persons referred to in point 1(a)(i) must, in accordance with the provisions of the Zorgverzekeringswet (Health Care Insurance Act), take out insurance with a health care insurer, and the persons referred to in point 1(a)(ii) must register with the College voor zorgverzekeringen (Health Care Insurance Board). (c) The provisions of the Zorgverzekeringswet (Health Care Insurance Act) and the Algemene Wet Bijzondere Ziektekosten (General Act on Exceptional Medical Expenses) concerning liability for the payment of contributions shall apply to the persons referred to in point (a) and the members of their families. In respect of members of the family, the contributions shall be levied on the person from whom the right to health care is derived with the exception of the members of the family of military personnel living in another State, who shall be levied directly. (d) The provisions of the Zorgverzekeringswet (Health Care Insurance Act) concerning late insurance shall apply mutatis mutandis in the event of late registration with the College voor zorgverzekeringen (Health Care Insurance Board) in respect of the persons referred to in point (a)(ii). (e) Persons entitled to benefits in kind by virtue of the legislation of a State other than the Netherlands who reside in the Netherlands or stay temporarily in the Netherlands shall be entitled to benefits in kind in accordance with the policy offered to insured persons in the Netherlands by the institution of the place of residence or the place of stay, taking into account Article 11(1), (2) and (3) and Article 19(1) of the Zorgverzekeringswet (Health Care Insurance Act), as well as to benefits in kind provided for by the Algemene Wet Bijzondere Ziektekosten (General Act on Exceptional Medical Expenses). (f) For the purposes of Articles SSC.21 to SSC.27 of this Protocol, the following benefits, in addition to pensions covered by Chapters 4 and 5 of Title III of this Protocol, shall be treated as pensions due under Dutch legislation: — pensions awarded under the Law of 6 January 1966 on pensions for civil servants and their survivors (Algemene burgerlijke pensioenwet) (Netherlands Civil Service Pensions Act), — pensions awarded under the Law of 6 October 1966 on pensions for military personnel and their survivors (Algemene militaire pensioenwet) (Military Pensions Act), — benefits for incapacity for work awarded under the Law of 7 June 1972 on benefits for incapacity for work for military personnel (Wetarbeidsongeschiktheidsvoorziening militairen) (Military Personnel Incapacity for Work Act), — pensions awarded under the Law of 15 February 1967 on pensions for employees of the NV Nederlandse Spoorwegen (Dutch Railway Company) and their survivors (Spoorwegpensioenwet) (Railway Pensions Act), — pensions awarded under the Reglement Dienstvoorwaarden Nederlandse Spoorwegen (governing conditions of employment of the Netherlands Railway Company), — benefits awarded to retired persons before reaching the pensionable age of 65 years under a pension designed to provide income for former employed persons in their old age, or benefits provided in the event of premature exit from the labour market under a scheme set up by the state or by an industrial agreement for persons aged 55 or over, — benefits awarded to military personnel and civil servants under a scheme applicable in the event of redundancy, superannuation and early retirement. (g) For the purposes of Article SSC.16(1) of this Protocol, the persons referred to in point (a)(ii) of this paragraph who stay temporarily in the Netherlands shall be entitled to benefits in kind in accordance with the policy offered to insured persons in the Netherlands by the institution of the place of stay, taking into account Article 11(1), (2) and (3) and Article 19(1) of the Zorgverzekeringswet (Health Care Insurance Act), as well as to benefits in kind provided for by the Algemene Wet Bijzondere Ziektekosten (General Act on Exceptional Medical Expenses). 2. Application of the Algemene Ouderdomswet (AOW) (General Old Age Pensions Act) (a) The reduction referred to in Article 13(1) of the AOW (General Old Age Pensions Act) shall not be applied for calendar years before 1 January 1957 during which a recipient not satisfying the conditions for having such years treated as periods of insurance: — resided in the Netherlands between the ages of 15 and 65, — while residing in another State, worked in the Netherlands for an employer established in the Netherlands, or — worked in another State during periods regarded as periods of insurance under the Dutch social security system. By way of derogation from Article 7 of the AOW, anyone who resided or worked in the Netherlands in accordance with the above conditions only prior to 1 January 1957 shall also be regarded as being entitled to a pension. (b) The reduction referred to in Article 13(1) of the AOW shall not apply to calendar years prior to 2 August 1989 during which a person, between the ages of 15 and 65, who is or was married was not insured under the above legislation, while being resident in the territory of a State other than the Netherlands, if these calendar years coincide with periods of insurance completed by the person's spouse under the above legislation or with calendar years to be taken into account under point 2(a), provided that the couple's marriage subsisted during that time. By way of derogation from Article 7 of the AOW, such a person shall be regarded as being entitled to a pension. (c) The reduction referred to in Article 13(2) of the AOW shall not apply to calendar years before 1 January 1957 during which a pensioner's spouse who fails to satisfy the conditions for having such years treated as periods of insurance: — resided in the Netherlands between the ages of 15 and 65, or — while residing in another State, worked in the Netherlands for an employer established in the Netherlands, or — worked in another State during periods regarded as periods of insurance under the Netherlands social security system. (d) The reduction referred to in Article 13(2) of the AOW shall not apply to calendar years prior to 2 August 1989 during which a pensioner's spouse resident in a State other than the Netherlands, between the ages of 15 and 65, was not insured under the AOW, if those calendar years coincide with periods of insurance completed by the pensioner under that legislation or with calendar years to be taken into account under point 2(a), provided that the couple's marriage subsisted during that time. (e) Points 2(a), 2(b), 2(c) and 2(d) shall not apply to periods which coincide with: — periods which may be taken into account for calculating pension rights under the old-age insurance legislation of a State other than the Netherlands, or — periods for which the person concerned has drawn an old-age pension under such legislation. Periods of voluntary insurance under the system of another State shall not be taken into account for the purposes of this point. (f) Points 2(a), 2(b), 2(c) and 2(d) shall apply only if the person concerned has resided in one or more States for 6 years after the age of 59 and only for such time as that person is resident in one of those States. (g) By way of derogation from Chapter IV of the AOW, anyone resident in a State other than the Netherlands whose spouse is covered by compulsory insurance under that legislation shall be authorised to take out voluntary insurance under that legislation for periods during which the spouse is compulsorily insured. This authorisation shall not cease where the spouse's compulsory insurance is terminated as a result of their death and where the survivor receives only a pension under the Algemene nabestaandenwet (General Surviving Relatives Act). In any event, the authorisation in respect of voluntary insurance ceases on the date on which the person reaches the age of 65. The contribution to be paid for voluntary insurance shall be set in accordance with the provisions relating to the determination of the contribution for voluntary insurance under the AOW. However, if the voluntary insurance follows on from a period of insurance as referred to in point 2(b), the contribution shall be set in accordance with the provisions relating to the determination of the contribution for compulsory insurance under the AOW, with the income to be taken into account being deemed to have been received in the Netherlands. (h) The authorisation referred to in point 2(g) shall not be granted to anyone insured under another State's legislation on pensions or survivors' benefits. (i) Anyone wishing to take out voluntary insurance under point 2(g) shall be required to apply for it to the Social Insurance Bank (Sociale Verzekeringsbank) not later than 1 year after the date on which the conditions for participation are fulfilled. 3. Application of the Algemene nabestaandenwet (ANW) (General Surviving Relatives Act) (a) Where the surviving spouse is entitled to a survivor's pension under the ANW (General Surviving Relatives Act) pursuant to Article SSC.46(3) of this Protocol, that pension shall be calculated in accordance with point (b) of Article SSC.47(1) of this Protocol. For the application of these provisions, periods of insurance prior to 1 October 1959 shall also be regarded as periods of insurance completed under Dutch legislation if during those periods the insured person, after the age of 15: — resided in the Netherlands; or — while resident in another State, worked in the Netherlands for an employer established in the Netherlands; or — worked in another State during periods regarded as periods of insurance under the Dutch social security system. (b) Account shall not be taken of the periods to be taken into consideration under point 3(a) which coincide with periods of compulsory insurance completed under the legislation of another State in respect of survivor's pensions. (c) For the purposes of point (b) of Article SSC.47(1) of this Protocol, only periods of insurance completed under Dutch legislation after the age of 15 shall be taken into account as periods of insurance. (d) By way of derogation from Article 63a(1) of the ANW, a person resident in a State other than the Netherlands whose spouse is compulsorily insured under the ANW shall be authorised to take out voluntary insurance under the ANW provided that such insurance has already begun by the date of application of this Protocol, but only for periods during which the spouse is compulsorily insured. That authorisation shall cease as from the date of termination of the spouse's compulsory insurance under the ANW, unless the spouse's compulsory insurance is terminated as a result of their death and where the survivor only receives a pension under the ANW. In any event, the authorisation in respect of voluntary insurance ceases on the date on which the person reaches the age of 65. The contribution to be paid for voluntary insurance shall be set in accordance with the provisions relating to the determination of contributions for voluntary insurance under the ANW. However, if the voluntary insurance follows on from a period of insurance as referred to in point 2(b), the contribution shall be set in accordance with the provisions relating to the determination of contributions for compulsory insurance under the ANW, with the income to be taken into account being deemed to have been received in the Netherlands. 4. Application of Dutch legislation relating to incapacity for work In calculating benefits under either the WAO, WIA or the WAZ, the Netherlands institutions shall take account of: — periods of paid employment, and periods treated as such, completed in the Netherlands before 1 July 1967, — periods of insurance completed under the WAO, — periods of insurance completed by the person concerned, after the age of 15, under the Algemene Arbeidsongeschiktheidswet (General Act on Incapacity for Work), in so far as they do not coincide with the periods of insurance completed under the WAO, — periods of insurance completed under the WAZ, — periods of insurance completed under the WIA. SPAIN 1. For the purpose of implementing point (1)(b) of Article SSC.47(1) of this Protocol, the years which the worker lacks to reach the pensionable or compulsory retirement age as stipulated under Article 31(4) of the consolidated version of the Ley de Clases Pasivas del Estado (Law on State Pensioners) shall be taken into account as actual years of service to the State only if at the time of the event in respect of which death pensions are due, the beneficiary was covered by Spain's special scheme for civil servants or was performing an activity assimilated under the scheme, or if, at the time of the event in respect of which the pensions are due, the beneficiary was performing an activity that would have required the person concerned to be included under the State's special scheme for civil servants, the armed forces or the judiciary, had the activity been performed in Spain. 2. (a) Under point (c) of Article SSC.51(1), the calculation of the theoretical Spanish benefit shall be carried out on the basis of the actual contributions of the person during the years immediately preceding payment of the last contribution to Spanish social security. Where, in the calculation of the basic amount for the pension, periods of insurance and/or residence under the legislation of other States have to be taken into account, the contribution basis in Spain which is closest in time to the reference periods shall be used for those periods, taking into account the development of the retail price index. (b) The amount of the pension obtained shall be increased by the amount of the increases and revaluations calculated for each subsequent year for pensions of the same nature. 3. Periods completed in other States which must be calculated in the special scheme for civil servants, the armed forces and the judicial administration, will be treated in the same way, for the purposes of Article SSC.51 of this Protocol, as the periods closest in time covered as a civil servant in Spain. 4. The additional amounts based on age referred to in the Second Transitional Provision of the General Law on Social Security shall be applicable to all beneficiaries under this Protocol who have contributions to their name under the Spanish legislation prior to 1 January 1967; it shall not be possible, by application of Article SSC.6 of this Protocol, to treat periods of insurance credited in another State prior to 1 January 1967 as being the same as contributions paid in Spain, solely for the purposes of this Protocol. The date corresponding to 1 January 1967 shall be 1 August 1970 for the Special Scheme for Seafarers and 1 April 1969 for the Special Social Security Scheme for Coal Mining. SWEDEN 1. The provisions of this Protocol on the aggregation of insurance periods and periods of residence shall not apply to the transitional provisions in the Swedish legislation on entitlement to guarantee pension for persons born in or before 1937 who have been resident in Sweden for a specified period before applying for a pension (Act 2000:798). 2. For the purpose of calculating income for notional income-related sickness compensation and income-related activity compensation in accordance with Chapter 8 of the Lag (1962:381) om allmän försäkring (the National Insurance Act), the following shall apply: (a) where the insured person, during the reference period, has also been subject to the legislation of one or more other States on account of activity as an employed or self-employed person, income in the State(s) concerned shall be deemed to be equivalent to the insured person's average gross income in Sweden during the part of the reference period in Sweden, calculated by dividing the earnings in Sweden by the number of years over which those earnings accrued; 3. (a) For the purpose of calculating notional pension assets for income-based survivor's pension (Act 2000:461), if the requirement in Swedish legislation for pension entitlement in respect of at least three out of the 5 calendar years immediately preceding the insured person's death (reference period) is not met, account shall also be taken of insurance periods completed in other States as if they had been completed in Sweden. Insurance periods in other States shall be regarded as based on the average Swedish pension base. If the person concerned has only 1 year in Sweden with a pension base, each insurance period in another State shall be regarded as constituting the same amount. (b) For the purpose of calculating notional pension credits for widows' pensions relating to deaths on or after 1 January 2003, if the requirement in Swedish legislation for pension credits in respect of at least two out of the 4 years immediately preceding the insured person's death (reference period) is not met and insurance periods were completed in another State during the reference period, those years shall be regarded as being based on the same pension credits as the Swedish year. UNITED KINGDOM 1. Where, in accordance with United Kingdom legislation, a person may be entitled to a retirement pension if: (a) the contributions of a former spouse are taken into account as if they were that person's own contributions; or (b) the relevant contribution conditions are satisfied by that person's spouse or former spouse, then provided, in each case, that the spouse or former spouse is or had been exercising an activity as an employed or self-employed person, and had been subject to the legislation of two or more States, the provisions of Chapter 5 of Title III of this Protocol shall apply in order to determine entitlement under United Kingdom legislation. In that case, references in Articles SSC.44 to SSC.55 of this Protocol to "periods of insurance" shall be construed as references to periods of insurance completed by: (i) a spouse or former spouse where a claim is made by: — a married woman, or — a person whose marriage has terminated otherwise than by the death of the spouse; or (ii) a former spouse, where a claim is made by: — a widower who immediately before pensionable age is not entitled to a widowed parent's allowance, or — a widow who immediately before pensionable age is not entitled to a widowed mother's allowance, widowed parent's allowance or widow's pension, or who is only entitled to an age-related widow's pension calculated pursuant to point (b) of Article SSC.47(1) of this Protocol, and for this purpose ‘age related widow's pension’ means a widow's pension payable at a reduced rate in accordance with section 39(4) of the Social Security Contributions and Benefits Act 1992. 2. For the purposes of Article SSC.8 of this Protocol in the case of old-age or survivors' cash benefits, pensions for accidents at work or occupational diseases and death grants, any beneficiary under United Kingdom legislation who is staying in the territory of another State shall, during that stay, be considered as if they resided in the territory of that other State. 3. (1) For the purpose of calculating an earnings factor in order to determine entitlement to benefits under United Kingdom legislation, for each week of activity as an employed person under the legislation of a Member State, and which commenced during the relevant income tax year within the meaning of United Kingdom legislation, the person concerned shall be deemed to have paid contributions as an employed earner, or have earnings on which contributions have been paid, on the basis of earnings equivalent to two-thirds of that year's upper earnings limit. (2) For the purposes of point (b) of Article SSC.47(1) of this Protocol, where: (a) in any income tax year starting on or after 6 April 1975, a person carrying out activity as an employed person has completed periods of insurance, employment or residence exclusively in a Member State, and the application of point (1) of this paragraph results in that year being counted as a qualifying year within the meaning of United Kingdom legislation for the purposes of point (b)(i) of Article SSC.47(1) of this Protocol, they shall be deemed to have been insured for 52 weeks in that year in that Member State; (b) any income tax year starting on or after 6 April 1975 does not count as a qualifying year within the meaning of United Kingdom legislation for the purposes of point (b)(i) of Article SSC.47(1) of this Protocol, any periods of insurance, employment or residence completed in that year shall be disregarded. (3) For the purpose of converting an earnings factor into periods of insurance, the earnings factor achieved in the relevant income tax year within the meaning of United Kingdom legislation shall be divided by that year's lower earnings limit. The result shall be expressed as a whole number, any remaining fraction being ignored. The figure so calculated shall be treated as representing the number of weeks of insurance completed under United Kingdom legislation during that year, provided that such figure shall not exceed the number of weeks during which in that year the person was subject to that legislation. ANNEX SSC-7 IMPLEMENTING PART TITLE I GENERAL PROVISIONS CHAPTER 1 Article SSCI.1 Definitions 1. For the purposes of this Annex, the definitions set out in Article SSC.1 of this Protocol apply. 2. In addition to the definitions referred to in paragraph 1: (a) "access point" means an entity providing: (i) an electronic contact point; (ii) automatic routing based on the address; and (iii) intelligent routing based on software that enables automatic checking and routing (for example, an artificial intelligence application) or human intervention; (b) "liaison body" means any body designated by the competent authority of a State for one or more of the branches of social security referred to in Article SSC.3 of this Protocol to respond to requests for information and assistance for the purposes of the application of this Protocol and of this Annex and which has to fulfil the tasks assigned to it under Title IV of this Annex; (c) "document" means a set of data, irrespective of the medium used, structured in such a way that it can be exchanged electronically and which must be communicated in order to enable the operation of this Protocol and this Annex; (d) "Structured Electronic Document" means any structured document in a format designed for the electronic exchange of information between States; (e) "transmission by electronic means" means the transmission of data using electronic equipment for the processing (including digital compression) of data and employing wires, radio transmission, optical technologies or any other electromagnetic means; (f) "fraud" means any deliberate act or deliberate omission to act, carried out with the intention to either: (i) receive social security benefits, or enable another person to receive social security benefits, when the conditions of entitlement to such benefits under the law of the State(s) concerned or this Protocol are not met; or (ii) avoid paying social security contributions, or enable another person to avoid paying social security contributions, when such contributions are required under the law of the State(s) concerned or this Protocol. CHAPTER 2 PROVISIONS CONCERNING COOPERATION AND EXCHANGES OF DATA Article SSCI.2 Scope and rules for exchanges between institutions 1. For the purposes of this Annex, exchanges between authorities of the States and institutions and persons covered by this Protocol shall be based on the principles of public service, efficiency, active assistance, rapid delivery and accessibility, including e-accessibility, in particular for the disabled and the elderly. 2. The institutions shall without delay provide or exchange all data necessary for establishing and determining the rights and obligations of persons to whom this Protocol applies. Such data shall be transferred between the States directly by the institutions themselves or indirectly via the liaison bodies. 3. Where a person has mistakenly submitted information, documents or claims to an institution in the territory of a State other than that in which the institution designated, in accordance with this Annex, is situated, the information, documents or claims shall be resubmitted without delay by the former institution to the institution designated in accordance with this Annex, indicating the date on which they were initially submitted. That date shall be binding on the latter institution. The institutions of the States shall not, however, be held liable, or be deemed to have taken a decision by virtue of their failure to act as a result of the late transmission of information, documents or claims by States' institutions. 4. Where data are transferred indirectly via the liaison body of the State of destination, time limits for responding to claims shall start from the date when that liaison body received the claim, as if it had been received by the institution in that State. Article SSCI.3 Scope and rules for exchanges between the persons concerned and institutions 1. The States shall ensure that the necessary information is made available to the persons concerned in order to inform them of the provisions introduced by this Protocol and this Annex to enable them to assert their rights. They shall also provide for user-friendly services. 2. Persons to whom this Protocol applies shall be required to forward to the relevant institution the information, documents or supporting evidence necessary to establish their situation or that of their families, to establish or maintain their rights and obligations and to determine the applicable legislation and their obligations under it. 3. To the extent necessary for the application of this Protocol and this Annex, the relevant institutions shall forward the information and issue the documents to the persons concerned without delay and in all cases within any time limits specified under the legislation of the State in question. The relevant institution shall notify the claimant residing or staying in another State of its decision directly or through the liaison body of the State of residence or stay. When refusing the benefits, it shall also indicate the reasons for refusal, the remedies and periods allowed for appeals. A copy of this decision shall be sent to other involved institutions. Article SSCI.4 Forms, documents and methods of exchanging data 1. Subject to Article SSCI.75 and Appendix SSCI-2, the structure, content and format of forms and documents issued on behalf of the States for the purposes of implementing this Protocol shall be agreed by the Specialised Committee on Social Security Coordination. 2. The transmission of data between the institutions or the liaison bodies may, subject to the approval of the Specialised Committee on Social Security Coordination, be carried out via the Electronic Exchange of Social Security Information. To the extent the forms and documents referred to in paragraph 1 are exchanged via the Electronic Exchange of Social Security Information, they shall respect the rules applicable to that system. Where the transmission of data between institutions or the liaison bodies is not carried out via the Electronic Exchange of Social Security Information, the relevant institutions and liaison bodies shall use the arrangements appropriate to each case, and favour the use of electronic means as far as possible. 3. In their communications with the persons concerned, the relevant institutions shall use the arrangements appropriate to each case, and favour the use of electronic means as far as possible. Article SSCI.5 Legal value of documents and supporting evidence issued in another State 1. Documents issued by the institution of a State and showing the position of a person for the purposes of the application of this Protocol and this Annex, and supporting evidence on the basis of which the documents have been issued, shall be accepted by the institutions of the other States for as long as they have not been withdrawn or declared to be invalid by the State in which they were issued. 2. Where there is doubt about the validity of a document or the accuracy of the facts on which the particulars contained therein are based, the institution of the State that receives the document shall ask the issuing institution for the necessary clarification and, where appropriate, the withdrawal of that document. The issuing institution shall reconsider the grounds for issuing the document and, if necessary, withdraw it. 3. Pursuant to paragraph 2, where there is doubt about the information provided by the persons concerned, the validity of a document or supporting evidence or the accuracy of the facts on which the particulars contained therein are based, the institution of the place of stay or residence shall, insofar as this is possible, at the request of the competent institution, proceed to the necessary verification of this information or document. 4. Where no agreement is reached between the institutions concerned, the matter may be brought before the Specialised Committee on Social Security Coordination by the competent authorities no earlier than one month following the date on which the institution that received the document submitted its request. The Specialised Committee on Social Security Coordination shall endeavour to reconcile the points of view within six months of the date on which the matter was brought before it. Article SSCI.6 Provisional application of legislation and provisional granting of benefits 1. Unless otherwise provided for in this Annex, where there is a difference of views between the institutions or authorities of two or more States concerning the determination of the applicable legislation, the person concerned shall be made provisionally subject to the legislation of one of those States, the order of priority being determined as follows: (a) the legislation of the State where the person actually pursues their employment or self-employment, if the employment or self-employment is pursued in only one State; (b) the legislation of the State of residence if the person concerned pursues employment or self-employment in two or more States and performs part of their activity or activities in the State of residence, or if the person concerned is neither employed nor self-employed; (c) in all other cases, the legislation of the State the application of which was first requested if the person pursues an activity, or activities, in two or more States. 2. Where there is a difference of views between the institutions or authorities of two or more States about which institution should provide the benefits in cash or in kind, the person concerned who could claim benefits if there was no dispute shall be entitled, on a provisional basis, to the benefits provided for by the legislation applied by the institution of that person's place of residence or, if that person does not reside on the territory of one of the States concerned, to the benefits provided for by the legislation applied by the institution to which the request was first submitted. 3. Where no agreement is reached between the institutions or authorities concerned, the matter may be brought before the Specialised Committee on Social Security Coordination by a Party no earlier than one month after the date on which the difference of views, as referred to in paragraph 1 or 2, arose. The Specialised Committee on Social Security Coordination shall seek to reconcile the points of view within six months of the date on which the matter was brought before it. 4. Where it is established either that the applicable legislation is not that of the State of provisional membership, or the institution which granted the benefits on a provisional basis was not the competent institution, the institution identified as being competent shall be deemed retroactively to have been so, as if that difference of views had not existed, at the latest from either the date of provisional membership or of the first provisional granting of the benefits concerned. 5. If necessary, the institution identified as being competent and the institution which provisionally paid the cash benefits or provisionally received contributions shall settle the financial situation of the person concerned as regards contributions and cash benefits paid provisionally, where appropriate, in accordance with Chapter 2 of Title IV of this Annex. Benefits in kind granted provisionally by an institution in accordance with paragraph 2 shall be reimbursed by the competent institution in accordance with Title IV of this Annex. Article SSCI.7 Provisional calculation of benefits and contributions 1. Unless otherwise provided for in this Annex, where a person is eligible for a benefit, or is liable to pay a contribution in accordance with this Protocol, and the competent institution does not have all the information concerning the situation in another State which is necessary to calculate definitively the amount of that benefit or contribution, that institution shall, on request of the person concerned, award this benefit or calculate this contribution on a provisional basis, if such a calculation is possible on the basis of the information at the disposal of that institution. 2. The benefit or the contribution concerned shall be recalculated once all the necessary supporting evidence or documents are provided to the institution concerned. CHAPTER 3 OTHER GENERAL PROVISIONS FOR THE APPLICATION OF THIS PROTOCOL Article SSCI.8 Other procedures between authorities and institutions 1. Two or more States, or their competent authorities, may agree procedures other than those provided for by this Annex, provided that such procedures do not adversely affect the rights or obligations of the persons concerned. 2. Any agreements concluded to this end shall be notified to the Specialised Committee on Social Security Coordination and listed in Appendix SSCI-1. 3. Provisions contained in implementing agreements concluded between two or more States with the same purpose as, or which are similar to, those referred to in paragraph 2, which are in force on the day preceding the entry into force of this Agreement, shall continue to apply, for the purposes of relations between those States, provided they are also included in Appendix SSCI-1 to this Protocol. Article SSCI.9 Prevention of overlapping of benefits Notwithstanding other provisions in this Protocol, when benefits due under the legislation of two or more States are mutually reduced, suspended or withdrawn, any amounts that would not be paid in the event of strict application of the rules concerning reduction, suspension or withdrawal laid down by the legislation of the State concerned shall be divided by the number of benefits subjected to reduction, suspension or withdrawal. Article SSCI.10 Elements for determining residence 1. Where there is a difference of views between the institutions of two or more States about the determination of the residence of a person to whom this Protocol applies, these institutions shall establish by common agreement the centre of interests of the person concerned, based on an overall assessment of all available information relating to relevant facts, which may include, as appropriate: (a) the duration and continuity of presence on the territory of the States concerned; (b) that person's situation, including: (i) the nature and the specific characteristics of any activity pursued, in particular the place where such activity is habitually pursued, the stability of the activity, and the duration of any work contract; (ii) that person's family status and family ties; (iii) the exercise of any non-remunerated activity; (iv) in the case of students, the source of that student's income; (v) that person's housing situation, in particular how permanent it is; (vi) the State in which that person is deemed to reside for taxation purposes. 2. Where the consideration of the various criteria based on relevant facts as set out in paragraph 1 does not lead to agreement between the institutions concerned, the person's intention, as it appears from such facts and circumstances, especially the reasons that led the person to move, shall be considered to be decisive for establishing that person's actual place of residence. 3. The centre of interests of a student who goes to another State to pursue a full-time course of study shall not be considered as being in the State of study for the entire duration of the course of study in that State, without prejudice to the possibility of rebutting this presumption. 4. Paragraph 3 applies mutatis mutandis to the family members of the student. Article SSCI.11 Aggregation of periods 1. For the purposes of applying Article SSC.7, the competent institution shall contact the institutions of the States to whose legislation the person concerned has also been subject in order to determine all the periods completed under their legislation. 2. The respective periods of insurance, employment, self-employment or residence completed under the legislation of a State shall be added to those completed under the legislation of any other State, insofar as necessary for the purposes of applying Article SSC.7, provided that these periods do not overlap. 3. Where a period of insurance or residence which is completed in accordance with compulsory insurance under the legislation of a State coincides with a period of insurance completed on the basis of voluntary insurance or continued optional insurance under the legislation of another State, only the period completed on the basis of compulsory insurance shall be taken into account. 4. Where a period of insurance or residence other than an equivalent period completed under the legislation of a State coincides with an equivalent period on the basis of the legislation of another State, only the period other than an equivalent period shall be taken into account. 5. Any period regarded as equivalent under the legislation of two or more States shall be taken into account only by the institution of the State to whose legislation the person concerned was last compulsorily subject before that period. In the event that the person concerned was not compulsorily subject to the legislation of a State before that period, the latter shall be taken into account by the institution of the State to whose legislation the person concerned was compulsorily subject for the first time after that period. 6. In the event that the time in which certain periods of insurance or residence were completed under the legislation of a State cannot be determined precisely, it shall be presumed that these periods do not overlap with periods of insurance or residence completed under the legislation of another State, and account shall be taken thereof, where advantageous to the person concerned, insofar as they can reasonably be taken into consideration. Article SSCI.12 Rules for conversion of periods 1. Where periods completed under the legislation of a State are expressed in units different from those provided for by the legislation of another State, the conversion needed for the purpose of aggregation under Article SSC.7 shall be carried out under the following rules: (a) the period to be used as the basis for the conversion shall be that communicated by the institution of the State under whose legislation the period was completed; (b) in the case of schemes where the periods are expressed in days the conversion from days to other units, and vice versa, as well as between different schemes based on days shall be calculated according to the following table: Scheme based on 1 day corresponds to 1 week corresponds to 1 month corresponds to 1 quarter corresponds to Maximum of days in one calendar year 5 days 9 hours 5 days 22 days 66 days 264 days 6 days 8 hours 6 days 26 days 78 days 312 days 7 days 6 hours 7 days 30 days 90 days 360 days (c) in the case of schemes where the periods are expressed in units other than days, (i) three months or 13 weeks shall be equivalent to one quarter, and vice versa; (ii) one year shall be equivalent to four quarters, 12 months or 52 weeks, and vice versa; (iii) for the conversion of weeks into months, and vice versa, weeks and months shall be converted into days in accordance with the conversion rules for the schemes based on six days in the table in point (b); (d) in the case of periods expressed in fractions, those figures shall be converted into the next smaller integer unit applying the rules laid down in points (b) and (c). Fractions of years shall be converted into months unless the scheme involved is based on quarters; (e) if the conversion under this paragraph results in a fraction of a unit, the next higher integer unit shall be taken as the result of the conversion under this paragraph. 2. The application of paragraph 1 shall not have the effect of producing, for the total sum of the periods completed during one calendar year, a total exceeding the number of days indicated in the last column in the table in point (b) of paragraph 1, 52 weeks, 12 months or four quarters. If the periods to be converted correspond to the maximum annual amount of periods under the legislation of the State in which they have been completed, the application of paragraph 1 shall not result within one calendar year in periods that are shorter than the possible maximum annual amount of periods provided under the legislation concerned. 3. The conversion shall be carried out either in one single operation covering all those periods which were communicated as an aggregate, or for each year, if the periods were communicated on a year-by-year basis. 4. Where an institution communicates periods expressed in days, it shall at the same time indicate whether the scheme it administers is based on five days, six days or seven days. TITLE II DETERMINATION OF THE LEGISLATION APPLICABLE Article SSCI.13 Details relating to Articles SSC.11 and SSC.12 of this Protocol 1. For the purposes of the application of point (a) of Article SSC.11(1), a "person who pursues an activity as an employed person in a State for an employer which normally carries out its activities there and who is sent by that employer to another State" shall include a person who is recruited with a view to being sent to another State, provided that, immediately before the start of that person's employment, the person concerned is already subject to the legislation of the State in which their employer is established. 2. For the purposes of the application of point (a) of Article SSC.11(1) of this Protocol, the words "which normally carries out its activities there" shall refer to an employer that ordinarily performs substantial activities, other than purely internal management activities, in the territory of the State in which it is established, taking account of all criteria characterising the activities carried out by the undertaking in question. The relevant criteria must be suited to the specific characteristics of each employer and the real nature of the activities carried out. 3. For the purposes of the application of point (b) of Article SSC.11(1) of this Protocol, the words "who normally pursues an activity as a self-employed person" shall refer to a person who habitually carries out substantial activities in the territory of the State in which that person is established. In particular, that person must have already pursued their activity for some time before the date when they wish to take advantage of the provisions of that Article and, during any period of temporary activity in another State, must continue to fulfil, in the State where they are established, the requirements for the pursuit of their activity in order to be able to pursue it on their return. 4. For the purposes of the application of point (b) of Article SSC.11(1) of this Protocol, the criterion for determining whether the activity that a self-employed person goes to pursue in another State is "similar" to the self-employed activity normally pursued shall be that of the actual nature of the activity, rather than of the designation of employed or self-employed activity that may be given to this activity by the other State. 5. For the purposes of the application of Article SSC.12(1) and (5) of this Protocol, a person who "normally pursues an activity as an employed person" in "one or more Member States as well as in the United Kingdom", or in "two or more Member States" respectively, shall refer to a person who simultaneously, or in alternation, for the same undertaking or employer or for various undertakings or employers, exercises one or more separate activities in such States. 6. For the purposes of Article SSC.12(1) and (5) of this Protocol, an employed flight crew or cabin crew member normally pursuing air passenger or freight services in two or more States shall be subject to the legislation of the State where the home base, as defined in Article SSC.1 of this Protocol, is located. 7. Marginal activities shall be disregarded for the purposes of determining the applicable legislation under Article SSC.12 of this Protocol. Article SSCI.15 shall apply to all cases under this Article. 8. For the purposes of the application of Article SSC.12(2) and (6) of this Protocol, a person who "normally pursues an activity as a self-employed person" in "one or more Member States as well as in the United Kingdom", or in "two or more Member States" respectively, shall refer, in particular, to a person who simultaneously or in alternation pursues one or more separate self-employed activities, irrespective of the nature of those activities, in such States. 9. For the purposes of distinguishing the activities under paragraphs 5 and 8 of this Article from the situations described in Article SSC.11(1) of this Protocol, the duration of the activity in one or more States (whether it is permanent or of an ad hoc or temporary nature) shall be decisive. For these purposes, an overall assessment shall be made of all the relevant facts including, in particular, in the case of an employed person, the place of work as defined in the employment contract. 10. For the purposes of the application of Article SSC.12(1), (2), (5) and (6) of this Protocol, a "substantial part of employed or self-employed activity" pursued in a State shall mean a quantitatively substantial part of all the activities of the employed or self-employed person pursued there, without this necessarily being the major part of those activities. 11. To determine whether a substantial part of the activities is pursued in a State, the following indicative criteria shall be taken into account: (a) in the case of an employed activity, the working time or the remuneration; and (b) in the case of a self-employed activity, the turnover, working time, number of services rendered or income. In the framework of an overall assessment, a share of less than 25 % in respect of the criteria mentioned above shall be an indicator that a substantial part of the activities is not being pursued in the relevant State. 12. For the purposes of the application of point (b) of Article SSC.12(2) of this Protocol, the "centre of interest" of the activities of a self-employed person shall be determined by taking account of all the aspects of that person's occupational activities, notably the place where the person's fixed and permanent place of business is located, the habitual nature or the duration of the activities pursued, the number of services rendered, and the intention of the person concerned as revealed by all the circumstances. 13. For the determination of the applicable legislation under paragraphs 10, 11 and 12, the institutions concerned shall take into account the situation projected for the following 12 calendar months. 14. If a person pursues his or her activity as an employed person in two or more States on behalf of an employer established outside the territory of the States, and if this person resides in a State without pursuing substantial activity there, they shall be subject to the legislation of the State of residence. Article SSCI.14 Procedures for the application of point (b) of Article SSC.10(3), Article SSC.10(4) and Article SSC.11 of this Protocol (on the provision of information to the institutions concerned) 1. Unless otherwise provided for by Article SSCI.15 of this Annex, where a person pursues their activity outside the competent State, the employer or, in the case of a person who does not pursue an activity as an employed person, the person concerned shall inform the competent institution of the State whose legislation is applicable thereof, whenever possible in advance. That institution shall issue the attestation referred to in Article SSCI.16(2) of this Annex to the person concerned and shall without delay make information concerning the legislation applicable to that person, pursuant to point (b) of Article SSC.10(3) or Article SSC.11 of this Protocol, available to the institution designated by the competent authority of the State in which the activity is pursued. 2. An employer within the meaning of Article SSC.10(4) of this Protocol who has an employee on board a vessel flying the flag of another State shall inform the competent institution of the State whose legislation is applicable thereof whenever possible in advance. That institution shall, without delay, make information concerning the legislation applicable to the person concerned, pursuant to Article SSC.10(4) of this Protocol, available to the institution designated by the competent authority of the State whose flag, the vessel on which the employee is to perform the activity, is flying. Article SSCI.15 Procedure for the application of Article SSC.12 of this Protocol 1. A person who pursues activities in two or more States, or where Article SSC.12(5) or (6) applies, shall inform the institution designated by the competent authority of the State of residence thereof. 2. The designated institution of the place of residence shall without delay determine the legislation applicable to the person concerned, having regard to Article SSC.12 of this Protocol and Article SSCI.13 of this Annex. That initial determination shall be provisional. The institution shall inform the designated institutions of each State in which an activity is pursued of its provisional determination. 3. The provisional determination of the applicable legislation, as provided for in paragraph 2, shall become definitive within two months of the institutions designated by the competent authorities of the State(s) concerned being informed of it, in accordance with paragraph 2, unless the legislation has already been definitively determined on the basis of paragraph 4, or at least one of the institutions concerned informs the institution designated by the competent authority of the State of residence by the end of this two-month period that it cannot yet accept the determination or that it takes a different view on this. 4. Where uncertainty about the determination of the applicable legislation requires contacts between the institutions or authorities of two or more States, at the request of one or more of the institutions designated by the competent authorities of the State(s) concerned, or of the competent authorities themselves, the legislation applicable to the person concerned shall be determined by common agreement, having regard to Article SSC.12 of this Protocol and the relevant provisions of Article SSCI.13 of this Annex. Where there is a difference of views between the institutions or competent authorities concerned, those bodies shall seek agreement in accordance with the conditions set out above and Article SSCI.6 shall apply. 5. The competent institution of the State whose legislation is determined to be applicable either provisionally or definitively shall without delay inform the person concerned. 6. If the person concerned fails to provide the information referred to in paragraph 1, this Article shall be applied at the initiative of the institution designated by the competent authority of the State of residence as soon as it is appraised of that person's situation, possibly via another institution concerned. Article SSCI.16 Provision of information to persons concerned and employers 1. The competent institution of the State whose legislation becomes applicable pursuant to Title II of this Protocol shall inform the person concerned and, where appropriate, their employer(s) of the obligations laid down in that legislation. It shall provide them with the necessary assistance to complete the formalities required by that legislation. 2. At the request of the person concerned or of the employer, the competent institution of the State whose legislation is applicable pursuant to Title II shall provide an attestation that such legislation is applicable and shall indicate, where appropriate, until what date and under what conditions. Article SSCI.17 Cooperation between institutions 1. The relevant institutions shall communicate to the competent institution of the State whose legislation is applicable to a person pursuant to Title II of this Protocol the necessary information required to establish the date on which that legislation becomes applicable and the contributions which that person and his or her employer(s) are liable to pay under that legislation. 2. The competent institution of the State whose legislation becomes applicable to a person pursuant to Title II of this Protocol shall make the information indicating the date on which the application of that legislation takes effect available to the institution designated by the competent authority of the State to whose legislation that person was last subject. Article SSCI.18 Cooperation in case of doubts about the validity of issued documents concerning the applicable legislation 1. Where there is doubt about the validity of a document showing the position of the person for the purposes of the applicable legislation or the accuracy of the facts on which the document is based, the institution of the State that receives the document shall ask the issuing institution for the necessary clarification and, where appropriate, the withdrawal or rectification of that document. The requesting institution shall substantiate its request and provide the relevant supporting documentation that gave rise to the request. 2. When receiving such a request, the issuing institution shall reconsider the grounds for issuing the document and, where an error is detected, withdraw it or rectify it within 30 working days from the receipt of the request. The withdrawal or rectification shall have retroactive effect. However, in cases where there is a risk of disproportionate outcome, and in particular, of the loss of status as an insured person for the whole or part of the relevant period in the State(s) concerned, the States shall consider a more proportionate arrangement in such case. When the available evidence permits the issuing institution to find that the applicant of the document has committed fraud, it shall withdraw or rectify the document without delay and with retroactive effect. TITLE III SPECIAL PROVISIONS CONCERNING THE VARIOUS CATEGORIES OF BENEFITS CHAPTER 1 SICKNESS, MATERNITY AND EQUIVALENT PATERNITY BENEFITS Article SSCI.19 General implementing provisions 1. The competent authorities or institutions shall ensure that any necessary information is made available to insured persons regarding the procedures and conditions for the granting of benefits in kind where such benefits are received in the territory of a State other than that of the competent institution. 2. Notwithstanding point (a) of Article SSC.6 of this Protocol, a State may become responsible for the cost of benefits in accordance with Article SSC.20 of this Protocol only if, either the insured person has made a claim for a pension under the legislation of that State, or in accordance with Articles SSC.21 to SSC.27 of this Protocol, they receive a pension under the legislation of that State. Article SSCI.20 Regime applicable in the event of the existence of more than one regime in the State of residence or stay If the legislation of the State of residence or stay comprises more than one scheme of sickness, maternity and paternity insurance for more than one category of insured persons, the provisions applicable under Articles SSC.15, SSC.17(1), SSC.18, SSC.20, SSC.22 and SSC.24 of this Protocol shall be those of the legislation on the general scheme for employed persons. Article SSCI.21 Residence in a State other than the competent State Procedure and scope of right 1. For the purposes of the application of Article SSC.15 of this Protocol, the insured person or members of that person's family shall be obliged to register promptly with the institution of the place of residence. Their right to benefits in kind in the State of residence shall be certified by a document issued by the competent institution upon request of the insured person or upon request of the institution of the place of residence. 2. The document referred to in paragraph 1 shall remain valid until the competent institution informs the institution of the place of residence of its cancellation. The institution of the place of residence shall inform the competent institution of any registration under paragraph 1 and of any change or cancellation of that registration. 3. This Article applies mutatis mutandis to the persons referred to in Articles SSC.20, SSC.22, SSC.23 and SSC.24 of this Protocol. Reimbursement 4. Where a person or the members of that person's family: (a) have been issued with the document referred to in paragraph 1; (b) have registered that document with the institution of the place of residence in accordance with paragraph 1; and (c) a health fee has been paid by or on behalf of the person or members of their family to the State of residence as part of an application for a permit to enter, stay, work or reside in that State, that person or members of that person's family may apply to the institution of the State of residence for reimbursement (in whole or part, as the case may be) of the health fee paid. 5. Where a claim is made in accordance with paragraph 1, the institution of the State of residence shall determine that claim within three calendar months, starting on the day the claim was received, and shall make any reimbursement in accordance with this Article. 6. Where the period of validity of the document referred to in paragraph 1 is less than the period of time in respect of which the health fee has been paid, the amount reimbursed shall not exceed that portion of the health fee which corresponds to the period for which the document had been issued. 7. Where the health fee was paid by another person on behalf of a person to whom this Article applies, reimbursement may be made to that other person. Article SSCI.22 Stay in a State other than the competent State Procedure and scope of right 1. For the purposes of the application of Article SSC.17 of this Protocol, the insured person shall present to the health care provider in the State of stay an entitlement document issued by the competent institution indicating his entitlement to benefits in kind. If the insured person does not have such a document, the institution of the place of stay, upon request or if otherwise necessary, shall contact the competent institution in order to obtain one. 2. That document shall indicate that the insured person is entitled to benefits in kind under the conditions laid down in Article SSC.17 of this Protocol on the same terms as those applicable to persons insured under the legislation of the State of stay, and shall satisfy the requirements in Appendix SSCI-2. 3. The benefits in kind referred to in Article SSC.17(1) of this Protocol shall refer to the benefits in kind which are provided in the State of stay, in accordance with its legislation, and which become necessary on medical grounds with a view to preventing an insured person from being forced to return, before the end of the planned duration of stay, to the competent State to obtain the necessary treatment. Procedure and arrangements for meeting the costs and providing reimbursement of benefits in kind 4. If the insured person has actually borne the costs of all or part of the benefits in kind provided within the framework of Article SSC.17 of this Protocol and if the legislation applied by the institution of the place of stay enables reimbursement of those costs to an insured person, they may send an application for reimbursement to the institution of the place of stay. In that case, that institution shall reimburse directly to that person the amount of the costs corresponding to those benefits within the limits of and under the conditions of the reimbursement rates laid down in its legislation. 5. If the reimbursement of such costs has not been requested directly from the institution of the place of stay, the costs incurred shall be reimbursed to the person concerned by the competent institution in accordance with the reimbursement rates administered by the institution of the place of stay or the amounts which would have been subject to reimbursement to the institution of the place of stay, if Article SSCI.47 had applied in the case concerned. The institution of the place of stay shall provide the competent institution, upon request, with all necessary information about these rates or amounts. 6. By way of derogation from paragraph 5, the competent institution may undertake the reimbursement of the costs incurred within the limits of and under the conditions of the reimbursement rates laid down in its legislation, provided that the insured person has agreed to this provision being applied to them. 7. If the legislation of the State of stay does not provide for reimbursement pursuant to paragraphs 4 and 5 in the case concerned, the competent institution may reimburse the costs within the limits of and under the conditions of the reimbursement rates laid down in its legislation, without the agreement of the insured person. 8. The reimbursement to the insured person shall not, in any event, exceed the amount of costs actually incurred by them. 9. In the case of substantial expenditure, the competent institution may pay the insured person an appropriate advance as soon as that person submits the application for reimbursement to it. Family Members 10. Paragraphs 1 to 9 apply mutatis mutandis to the members of the family of the insured person. Reimbursement for students 11. Where a person: (a) holds a valid entitlement document referred to in Appendix SSCI-2 issued by the competent institution; (b) has been accepted by a higher education institution in a State other than the competent State ("State of study") to pursue a full-time course of study leading to a higher education qualification recognised by that State, including diplomas, certificates or doctoral degrees at a higher education institution, which may cover a preparatory course prior to such education, in accordance with national law, or compulsory training; (c) does not exercise, or has not exercised, an activity as an employed or self-employed person in the State of study during the period to which the health fee relates; and (d) a health fee has been paid by or on behalf of that person to the State of study as part of an application for a permit to enter, stay or reside for the purposes of pursuing a full-time course of study in that State; that person may apply to the institution of the State of study for reimbursement (in whole or part, as the case may be) of the health fee paid. 12. Where a claim is made in accordance with paragraph 11, the institution of the State of study shall process and settle that claim within a reasonable period but not later than six calendar months starting on the day the claim was received and make any reimbursement in accordance with this Article. 13. Where the period of validity of the entitlement document referred to in point (a) of paragraph 11 is less than the period of time in respect of which the health fee has been paid, the amount of the health fee reimbursed shall be the amount paid which corresponds to the period of validity of that document. 14. Where the health fee was paid by another person on behalf of a person to whom this Article applies, reimbursement may be made to that other person. 15. Paragraphs 11 to 14 apply mutatis mutandis to the members of the family of that person. 16. This Article shall enter into force 12 months after the date of entry into force of this Agreement. 17. A person who satisfied the conditions in paragraph 11 in the period between the entry into force of this Agreement and the date specified in paragraph 16 may, upon the entry into force of this Article, make a claim for reimbursement under paragraph 11 in relation to that period. 18. By way of derogation from Article SSC.5(1), charges may be imposed by the State of study in accordance with its national law in respect of benefits in kind that do not fulfil the criteria set out in point (a) of Article SSC.17(1) and which are provided to a person in respect of whom reimbursement has been made during that person's stay for the period to which that reimbursement relates. Article SSCI.23 Scheduled treatment Authorisation procedure 1. For the purposes of the application of Article SSC.18(1) of this Protocol, the insured person shall present a document issued by the competent institution to the institution of the place of stay. For the purposes of this Article, the competent institution shall mean the institution which bears the cost of the scheduled treatment; in the cases referred to in Articles SSC.18(4) and SSC.25(5) of this Protocol, in which the benefits in kind provided in the State of residence are reimbursed on the basis of fixed amounts, the competent institution shall mean the institution of the place of residence. 2. If an insured person does not reside in the competent State, they shall request authorisation from the institution of the place of residence, which shall forward it to the competent institution without delay. In that event, the institution of the place of residence shall certify in a statement whether the conditions set out in the second sentence of Article SSC.18(2) of this Protocol are met in the State of residence. The competent institution may refuse to grant the requested authorisation only if, in accordance with the assessment of the institution of the place of residence, the conditions set out in the second sentence of Article SSC.18(2) of this Protocol are not met in the State of residence of the insured person, or if the same treatment can be provided in the competent State itself, within a time-limit which is medically justifiable, taking into account the current state of health and the probable course of illness of the person concerned. The competent institution shall inform the institution of the place of residence of its decision. In the absence of a reply within the deadlines set by its national legislation, the authorisation shall be considered to have been granted by the competent institution. 3. If an insured person who does not reside in the competent Party is in need of urgent vitally necessary treatment, and the authorisation cannot be refused in accordance with the second sentence of Article SSC.18(2) of this Protocol, the authorisation shall be granted by the institution of the place of residence on behalf of the competent institution, which shall be immediately informed by the institution of the place of residence. The competent institution shall accept the findings and the treatment options of the doctors approved by the institution of the place of residence that issues the authorisation, concerning the need for urgent vitally necessary treatment. 4. At any time during the procedure granting the authorisation, the competent institution shall retain the right to have the insured person examined by a doctor of its own choice in the Party of stay or residence. 5. The institution of the place of stay shall, without prejudice to any decision regarding authorisation, inform the competent institution if it appears medically appropriate to supplement the treatment covered by the existing authorisation. Meeting the cost of benefits in kind incurred by the insured person 6. Without prejudice to paragraph 7, Article SSCI.22(4) and (5) apply mutatis mutandis. 7. If the insured person has actually borne all or part of the costs for the authorised medical treatment themselves and the costs which the competent institution is obliged to reimburse to the institution of the place of stay or to the insured person according to paragraph 6 (actual cost) are lower than the costs which it would have had to assume for the same treatment in the competent State (notional cost), the competent institution shall reimburse, upon request, the cost of treatment incurred by the insured person up to the amount by which the notional cost exceeds the actual cost. The reimbursed sum may not, however, exceed the costs actually incurred by the insured person and may take account of the amount which the insured person would have had to pay if the treatment had been delivered in the competent State. Meeting the costs of travel and stay as part of scheduled treatment 8. Where the national legislation of the competent institution provides for the reimbursement of the costs of travel and stay which are inseparable from the treatment of the insured person, such costs for the person concerned and, if necessary, for a person who must accompany them, shall be assumed by this institution when an authorisation is granted in the case of treatment in another State. Family members 9. Paragraphs 1 to 8 apply mutatis mutandis to the members of the family of the insured person. Article SSCI.24 Cash benefits relating to incapacity for work in the event of stay or residence in a State other than the competent State Procedure to be followed by the insured person 1. If the legislation of the competent State requires that the insured person presents a certificate in order to be entitled to cash benefits relating to incapacity for work pursuant to Article SSC.19(1) of this Protocol, the insured person shall ask the doctor of the State of residence who established that person's state of health to certify his or her incapacity for work and its probable duration. 2. The insured person shall send the certificate to the competent institution within the time limit laid down by the legislation of the competent State. 3. Where the doctors providing treatment in the State of residence do not issue certificates of incapacity for work, and where such certificates are required under the legislation of the competent State, the person concerned shall apply directly to the institution of the place of residence. That institution shall immediately arrange for a medical assessment of the person's incapacity for work and for the certificate referred to in paragraph 1 to be drawn up. The certificate shall be forwarded to the competent institution forthwith. 4. The forwarding of the document referred to in paragraphs 1, 2 and 3 shall not exempt the insured person from fulfilling the obligations provided for by the applicable legislation, in particular with regard to that person's employer. Where appropriate, the employer or the competent institution may call upon the employee to participate in activities designed to promote and assist his or her return to employment. Procedure to be followed by the institution of the State of residence 5. At the request of the competent institution, the institution of the place of residence shall carry out any necessary administrative checks or medical examinations of the person concerned in accordance with the legislation applied by this latter institution. The report of the examining doctor concerning, in particular, the probable duration of the incapacity for work, shall be forwarded without delay by the institution of the place of residence to the competent institution. Procedure to be followed by the competent institution 6. The competent institution shall reserve the right to have the insured person examined by a doctor of its choice. 7. Without prejudice to the second sentence of Article SSC.19(1) of this Protocol, the competent institution shall pay the cash benefits directly to the person concerned and shall, where necessary, inform the institution of the place of residence thereof. 8. For the purposes of the application of Article SSC.19(1) of this Protocol, the particulars of the certificate of incapacity for work of an insured person drawn up in another State on the basis of the medical findings of the examining doctor or institution shall have the same legal value as a certificate drawn up in the competent State. 9. If the competent institution refuses the cash benefits, it shall notify its decision to the insured person and at the same time to the institution of the place of residence. Procedure in the event of a stay in a State other than the competent State 10. Paragraphs 1 to 9 apply mutatis mutandis when the insured person stays in a State other than the competent State. Article SSCI.25 Contributions by pensioners If a person receives a pension from more than one State, the amount of contributions deducted from all the pensions paid shall, under no circumstances, be greater than the amount deducted in respect of a person who receives the same amount of pension from the competent State. Article SSCI.26 Special implementing measures 1. When a person or a group of persons are exempted upon request from compulsory sickness insurance and such persons are thus not covered by a sickness insurance scheme to which this Protocol applies, the institution of a State shall not, solely because of this exemption, become responsible for bearing the costs of benefits in kind or in cash provided to such persons or to a member of their family under Articles SSC.15 to SSC.30 of this Protocol. 2. When the persons referred to in paragraph 1 and the members of their families reside in a State where the right to receive benefits in kind is not subject to conditions of insurance, or of activity as an employed or self-employed person, they shall be liable to pay the full costs of benefits in kind provided in their State of residence. CHAPTER 2 BENEFITS IN RESPECT OF ACCIDENTS AT WORK AND OCCUPATIONAL DISEASES Article SSCI.27 Right to benefits in kind and in cash in the event of residence or stay in a State other than the competent State 1. For the purposes of the application of Article SSC.31 of this Protocol, the procedures laid down in Articles SSCI.21 to SSCI.24 of this Annex apply mutatis mutandis. 2. When providing special benefits in kind in connection with accidents at work and occupational diseases under the national legislation of the State of stay or residence, the institution of that State shall without delay inform the competent institution. Article SSCI.28 Procedure in the event of an accident at work or occupational disease which occurs in a State other than the competent State 1. If an accident at work occurs or an occupational disease is diagnosed for the first time in a State other than the competent State, the declaration or notification of the accident at work or the occupational disease, where the declaration or notification exists under national legislation, shall be carried out in accordance with the legislation of the competent State, without prejudice, where appropriate, to any other applicable legal provisions in force in the State in which the accident at work occurred or in which the first medical diagnosis of the occupational disease was made, which remain applicable in such cases. The declaration or notification shall be addressed to the competent institution. 2. The institution of the State in the territory of which the accident at work occurred or in which the occupational disease was first diagnosed, shall notify the competent institution of medical certificates drawn up in the territory of that State. 3. Where, as a result of an accident while travelling to or from work which occurs in the territory of a State other than the competent State, an inquiry is necessary in the territory of the first State in order to determine any entitlement to relevant benefits, a person may be appointed for that purpose by the competent institution, which shall inform the authorities of that State. The institutions shall cooperate with each other in order to assess all relevant information and to consult the reports and any other documents relating to the accident. 4. Following treatment, a detailed report accompanied by medical certificates relating to the permanent consequences of the accident or disease, in particular the injured person's present state and the recovery or stabilisation of injuries, shall be sent upon request of the competent institution. The relevant fees shall be paid by the institution of the place of residence or of stay, where appropriate, at the rate applied by that institution to the charge of the competent institution. 5. At the request of the institution of the place of residence or stay, where appropriate, the competent institution shall notify it of the decision setting the date for the recovery or stabilisation of injuries and, where appropriate, the decision concerning the granting of a pension. Article SSCI.29 Disputes concerning the occupational nature of the accident or disease 1. Where the competent institution disputes the application of the legislation relating to accidents at work or occupational diseases under Article SSC.31(2) of this Protocol, it shall without delay inform the institution of the place of residence or stay which provided the benefits in kind, which will then be considered as sickness insurance benefits. 2. When a final decision has been taken on that subject, the competent institution shall, without delay, inform the institution of the place of residence or stay which provided the benefits in kind. Where an accident at work or occupational disease is not established, benefits in kind shall continue to be provided as sickness benefits if the person concerned is entitled to them. Where an accident at work or occupational disease is established, sickness benefits in kind provided to the person concerned shall be considered as accident at work or occupational disease benefits from the date on which the accident at work occurred or the occupational disease was first medically diagnosed. 3. The second subparagraph of Article SSCI.6(5) applies mutatis mutandis. Article SSCI.30 Procedure in the event of exposure to the risk of an occupational disease in two or more States 1. In the case referred to in Article SSC.33 of this Protocol, the declaration or notification of the occupational disease shall be sent to the competent institution for occupational diseases of the last State under the legislation of which the person concerned pursued an activity likely to cause that disease. When the institution to which the declaration or notification was sent establishes that an activity likely to cause the occupational disease in question was last pursued under the legislation of another State, it shall send the declaration or notification and all accompanying certificates to the equivalent institution in that State. 2. Where the institution of the last State under the legislation of which the person concerned pursued an activity likely to cause the occupational disease in question establishes that the person concerned or his survivors do not meet the requirements of that legislation, inter alia, because the person concerned had never pursued in that State an activity which caused the occupational disease or because that State does not recognise the occupational nature of the disease, that institution shall forward without delay the declaration or notification and all accompanying certificates, including the findings and reports of medical examinations performed by the first institution to the institution of the previous State under the legislation of which the person concerned pursued an activity likely to cause the occupational disease in question. 3. Where appropriate, the institutions shall reiterate the procedure set out in paragraph 2 going back as far as the equivalent institution in the State under whose legislation the person concerned first pursued an activity likely to cause the occupational disease in question. Article SSCI.31 Exchange of information between institutions and advance payments in the event of an appeal against rejection 1. In the event of an appeal against a decision to refuse benefits taken by the institution of a State under the legislation of which the person concerned pursued an activity likely to cause the occupational disease in question, that institution shall inform the institution to which the declaration or notification was sent, in accordance with the procedure provided for in Article SSCI.30(2), and shall subsequently inform it when a final decision is reached. 2. Where a person is entitled to benefits under the legislation applied by the institution to which the declaration or notification was sent, that institution shall make the advance payments, the amount of which shall be determined, where appropriate, after consulting the institution which made the decision against which the appeal was lodged, and in such a way that overpayments are avoided. The latter institution shall reimburse the advance payments made if, as a result of the appeal, it is obliged to provide those benefits. That amount will then be deducted from the benefits due to the person concerned, in accordance with the procedure provided for in Articles SSCI.56 and SSCI.57. 3. The second subparagraph of Article SSCI.6(5) applies mutatis mutandis. Article SSCI.32 Aggravation of an occupational disease In the cases covered by Article SSC.34 of this Protocol, the claimant must provide the institution in the State from which they are claiming entitlement to benefits with details concerning benefits previously granted for the occupational disease in question. That institution may contact any other previously competent institution in order to obtain the information it considers necessary. Article SSCI.33 Assessment of the degree of incapacity in the event of occupational accidents or diseases which occurred previously or subsequently Where a previous or subsequent incapacity for work was caused by an accident which occurred when the person concerned was subject to the legislation of a State which makes no distinction according to the origin of the incapacity to work, the competent institution or the body designated by the competent authority of the State in question shall: (a) upon request by the competent institution of another State, provide information concerning the degree of the previous or subsequent incapacity for work, and where possible, information making it possible to determine whether the incapacity is the result of an accident at work within the meaning of the legislation applied by the institution in the other State; (b) take into account the degree of incapacity caused by these previous or subsequent cases when determining the right to benefits and the amount, in accordance with the applicable legislation. Article SSCI.34 Submission and investigation of claims for pensions or supplementary allowances In order to receive a pension or supplementary allowance under the legislation of a State, the person concerned or their survivors residing in the territory of another State shall submit, where appropriate, a claim either to the competent institution or to the institution of the place of residence, which shall send it to the competent institution. The claim shall contain the information required under the legislation applied by the competent institution. CHAPTER 3 DEATH GRANTS Article SSCI.35 Claim for death grants For the purposes of Articles SSC.37 and SSC.38 of this Protocol, the claim for death grants shall be sent either to the competent institution or to the institution of the claimant's place of residence, which shall send it to the competent institution. The claim shall contain the information required under the legislation applied by the competent institution. CHAPTER 4 INVALIDITY BENEFITS AND OLD-AGE AND SURVIVORS' PENSIONS Article SSCI.36 Additional provisions for the calculation of the benefit 1. For the purposes of calculating the theoretical amount and the actual amount of the benefit in accordance with point (b) of Article SSC.47(1) of this Protocol, the rules provided for in Article SSCI.11(3), (4), (5) and (6) of this Annex apply. 2. Where periods of voluntary or optional continued insurance have not been taken into account under Article SSCI.11(3) of this Annex, the institution of the State under whose legislation those periods were completed shall calculate the amount corresponding to those periods under the legislation it applies. The actual amount of the benefit, calculated in accordance with point (b) of Article SSC.47(1) of this Protocol, shall be increased by the amount corresponding to periods of voluntary or optional continued insurance. 3. The institution of each State shall calculate, under the legislation it applies, the amount due corresponding to periods of voluntary or optional continued insurance which, under point (c) of Article SSC.48(3) of this Protocol, shall not be subject to the another State's rules relating to withdrawal, reduction or suspension. Where the legislation applied by the competent institution does not allow it to determine this amount directly, on the grounds that that legislation allocates different values to insurance periods, a notional amount may be established. The Specialised Committee on Social Security Coordination shall lay down the detailed arrangements for the determination of that notional amount. Article SSCI.37 Claims for benefits Submission of claims for old-age and survivors' pensions 1. The claimant shall submit a claim to the institution of his place of residence or to the institution of the last State whose legislation was applicable. If the person concerned was not, at any time, subject to the legislation applied by the institution of the place of residence, that institution shall forward the claim to the institution of the last State whose legislation was applicable. 2. The date of submission of the claim shall apply in all the institutions concerned. 3. By way of derogation from paragraph 2, if the claimant does not, despite having been asked to do so, notify the fact that he or she has been employed or has resided in other States, the date on which the claimant completes his or her initial claim or submits a new claim for his or her missing periods of employment or/and residence in a State shall be considered as the date of submission of the claim to the institution applying the legislation in question, subject to more favourable provisions of that legislation. Article SSCI.38 Certificates and information to be submitted with the claim by the claimant 1. The claim shall be submitted by the claimant in accordance with the provisions of the legislation applied by the institution referred to in Article SSCI.37(1) and be accompanied by the supporting documents required by that legislation. In particular, the claimant shall supply all available relevant information and supporting documents relating to periods of insurance (institutions, identification numbers), employment (employers) or self-employment (nature and place of activity) and residence (addresses) which may have been completed under other legislation, as well as the length of those periods. 2. Where, in accordance with Article SSC.45(1) of this Protocol, the claimant requests deferment of the award of old-age benefits under the legislation of one or more States, the claimant shall state that in their claim and specify under which legislation the deferment is requested. In order to enable the claimant to exercise that right, the institutions concerned shall, upon the request of the claimant, notify them of all the information available to them so that he or she can assess the consequences of concurrent or successive awards of benefits which they might claim. 3. Should the claimant withdraw a claim for benefits provided for under the legislation of a particular State, that withdrawal shall not be considered as a concurrent withdrawal of claims for benefits under the legislation of another State. Article SSCI.39 Investigation of claims by the institutions concerned Contact institution 1. The institution to which the claim for benefits is submitted or forwarded in accordance with Article SSCI.37(1) shall be referred to hereinafter as the "contact institution". The institution of the place of residence shall not be referred to as the contact institution if the person concerned has not, at any time, been subject to the legislation which that institution applies. In addition to investigating the claim for benefits under the legislation which it applies, that institution shall, in its capacity as contact institution, promote the exchange of data, the communication of decisions and the operations necessary for the investigation of the claim by the institutions concerned, and supply the claimant, upon request, with any information relevant to the aspects of the investigation which arise under this Protocol, and keep the claimant informed of its progress. Investigation of claims for old-age and survivors pensions 2. The contact institution shall, without delay, send claims for benefits and all the documents which it has available and, where appropriate, the relevant documents supplied by the claimant to all the institutions in question so that they can all start the investigation of the claim concurrently. The contact institution shall notify the other institutions of periods of insurance or residence subject to its legislation. It shall also indicate which documents shall be submitted at a later date and supplement the claim as soon as possible. 3. Each of the institutions in question shall notify the contact institution and the other institutions in question, as soon as possible, of the periods of insurance or residence subject to their legislation. 4. Each of the institutions in question shall calculate the amount of benefits in accordance with Article SSC.47 of this Protocol and shall notify the contact institution and the other institutions concerned of its decision, of the amount of benefits due and of any information required for the purposes of Articles SSC.48 to SSC.50 of this Protocol. 5. Should an institution establish, on the basis of the information referred to in paragraphs 2 and 3 of this Article, that Article SSC.52(2) or (3) of this Protocol is applicable, it shall inform the contact institution and the other institutions concerned. Article SSCI.40 Notification of decisions to the claimant 1. Each institution shall notify the claimant of the decision it has taken in accordance with the applicable legislation. Each decision shall specify the remedies and periods allowed for appeals. Once the contact institution has been notified of all decisions taken by each institution, it shall send the claimant and the other institutions concerned a summary of those decisions. A model summary shall be drawn up by the Specialised Committee on Social Security Coordination. The summary shall be sent to the claimant in the language of the institution or, at the request of the claimant, in any language of their choice, including English, recognised as an official language of the Union. 2. Where it appears to the claimant following receipt of the summary that his or her rights may have been adversely affected by the interaction of decisions taken by two or more institutions, the claimant shall have the right to a review of the decisions by the institutions concerned within the time limits laid down in the respective national legislation. The time limits shall commence on the date of receipt of the summary. The claimant shall be notified of the result of the review in writing. Article SSCI.41 Determination of the degree of invalidity Each institution shall, in accordance with its legislation, have the possibility of having the claimant examined by a medical doctor or other expert of its choice to determine the degree of invalidity. However, the institution of a State shall take into consideration documents, medical reports and administrative information collected by the institution of any other State as if they had been drawn up in its own territory. Article SSCI.42 Provisional instalments and advance payment of a benefit 1. Notwithstanding Article SSCI.7 of this Annex, any institution which establishes, while investigating a claim for benefits, that the claimant is entitled to an independent benefit under the applicable legislation, in accordance with point (a) of Article SSC.47(1) of this Protocol, shall pay that benefit without delay. That payment shall be considered provisional if the amount might be affected by the result of the claim investigation procedure. 2. Whenever it is evident from the information available that the claimant is entitled to a payment from an institution under point (b) of Article SSC.47(1) of this Protocol, that institution shall make an advance payment, the amount of which shall be as close as possible to the amount which will probably be paid under point (b) of Article SSC.47(1) of this Protocol. 3. Each institution which is obliged to pay the provisional benefits or advance payment under paragraph 1 or 2 shall inform the claimant without delay, specifically drawing the claimant's attention to the provisional nature of the measure and any rights of appeal in accordance with its legislation. Article SSCI.43 New calculation of benefits 1. Where there is a new calculation of benefits in accordance with Articles SSC.45(4) and SSC.54(1) of this Protocol, Article SSCI.42 of this Annex shall be applicable mutatis mutandis. 2. Where there is a new calculation, withdrawal or suspension of the benefit, the institution which took the decision shall inform the person concerned without delay and shall inform each of the institutions in respect of which the person concerned has an entitlement. Article SSCI.44 Measures intended to accelerate the pension calculation process 1. In order to facilitate and accelerate the investigation of claims and the payment of benefits, the institutions to whose legislation a person has been subject shall: (a) exchange with or make available to institutions of other States the elements for identifying persons who change from one applicable national legislation to another, and together ensure that those identification elements are retained and correspond, or, failing that, provide those persons with the means to access their identification elements directly; (b) sufficiently in advance of the minimum age for commencing pension rights or before an age to be determined by national legislation, exchange with or make available to the person concerned and to institutions of other States information (periods completed or other important elements) on the pension entitlements of persons who have changed from one applicable legislation to another or, failing that, inform those persons of, or provide them with, the means of familiarising themselves with their prospective benefit entitlement. 2. For the purposes of paragraph 1, the Specialised Committee on Social Security Coordination shall determine the elements of information to be exchanged or made available and shall establish the appropriate procedures and mechanisms, taking account of the characteristics, administrative and technical organisation, and the technological means at the disposal of national pension schemes. The Specialised Committee on Social Security Coordination shall ensure the implementation of those pension schemes by organising a follow-up to the measures taken and their application. 3. For the purposes of paragraph 1, the institution in the first State where a person is allocated a Personal Identification Number (PIN) for the purposes of social security administration should be provided with the information referred to in this Article. Article SSCI.45 Coordination measures in the States 1. Without prejudice to Article SSC.46 of this Protocol, where national legislation includes rules for determining the institution responsible or the scheme applicable or for designating periods of insurance to a specific scheme, those rules shall be applied, taking into account only periods of insurance completed under the legislation of the State concerned. 2. Where national legislation includes rules for the coordination of special schemes for civil servants and the general scheme for employed persons, those rules shall not be affected by the provisions of this Protocol and of this Annex. CHAPTER 5 UNEMPLOYMENT BENEFITS Article SSCI.46 Aggregation of periods and calculation of benefits 1. Article SSCI.11(1) of this Annex applies mutatis mutandis to Article SSC.56 of this Protocol. Without prejudice to the underlying obligations of the institutions involved, the person concerned may submit to the competent institution a document issued by the institution of the State to whose legislation they were subject in respect of that person's last activity as an employed or self-employed person specifying the periods completed under that legislation. 2. For the purpose of applying Article SSC.57 of this Protocol, the competent institution of a State whose legislation provides that the calculation of benefits varies with the number of members of the family shall also take into account the members of the family of the person concerned residing in another State as if they resided in the competent State. This provision shall not apply where, in the State of residence of members of the family, another person is entitled to unemployment benefits calculated on the basis of the number of members of the family. TITLE IV FINANCIAL PROVISIONS CHAPTER 1 REIMBURSEMENT OF THE COST OF BENEFITS IN APPLICATION OF ARTICLE SSC.30 AND ARTICLE SSC.36 OF THIS PROTOCOL SECTION 1 REIMBURSEMENT ON THE BASIS OF ACTUAL EXPENDITURE Article SSCI.47 Principles 1. For the purpose of applying Article SSC.30 and Article SSC.36 of this Protocol, the actual amount of the expenses for benefits in kind, as shown in the accounts of the institution that provided them, shall be reimbursed to that institution by the competent institution, except where Article SSCI.57 of this Annex is applicable. 2. If any or part of the actual amount of the expenses for benefits referred to in paragraph 1 is not shown in the accounts of the institution that provided them, the amount to be refunded shall be determined on the basis of a lump-sum payment calculated from all the appropriate references obtained from the data available. The Specialised Committee on Social Security Coordination shall assess the bases to be used for calculation of the lump-sum payment and shall decide the amount thereof. 3. Higher rates than those applicable to the benefits in kind provided to insured persons subject to the legislation applied by the institution providing the benefits referred to in paragraph 1 may not be taken into account in the reimbursement. SECTION 2 REIMBURSEMENT ON THE BASIS OF FIXED AMOUNTS Article SSCI.48 Identification of the State(s) concerned 1. The States referred to in Article SSC.30(2) of this Protocol, whose legal or administrative structures are such that the use of reimbursement on the basis of actual expenditure is not appropriate, are listed in Appendix SSCI-3 to this Annex. 2. In the case of the States listed in Appendix SSCI-3, the amount of benefits in kind supplied to: (a) family members who do not reside in the same State as the insured person, as provided for in Article SSC.15 of this Protocol; and to (b) pensioners and members of their family, as provided for in Article SSC.22(1), Articles SSC.23 and SSC.24 of this Protocol; shall be reimbursed by the competent institutions to the institutions providing those benefits, on the basis of a fixed amount established for each calendar year. This fixed amount shall be as close as possible to actual expenditure. Article SSCI.49 Calculation method of the monthly fixed amounts and the total fixed amount 1. For each creditor State, the monthly fixed amount per person (Fi) for a calendar year shall be determined by dividing the annual average cost per person (Yi), broken down by age group (i), by 12 and by applying a reduction (X) to the result in accordance with the following formula: Fi = Yi*1/12*(1-X) Where: — the index (i = 1, 2 and 3) represents the three age groups used for calculating the fixed amounts: — i = 1: persons aged under 20, — i = 2: persons aged from 20 to 64, — i = 3: persons aged 65 and over, — Yi represents the annual average cost per person in age group i, as defined in paragraph 2, — the coefficient X (0.20 or 0.15) represents the reduction as defined in paragraph 3. 2. The annual average cost per person (Yi) in age group i shall be obtained by dividing the annual expenditure on all benefits in kind provided by the institutions of the creditor State to all persons in the age group concerned subject to its legislation and residing within its territory by the average number of persons concerned in that age group in the calendar year in question. The calculation shall be based on the expenditure under the schemes referred to in Article SSCI.20. 3. The reduction to be applied to the monthly fixed amount shall, in principle, be equal to 20 % (X = 0.20). It shall be equal to 15 % (X = 0.15) for pensioners and members of their family where the competent State is not listed in Annex SSC-3 to this Protocol. 4. For each debtor State, the total fixed amount for a calendar year shall be the sum of the products obtained by multiplying, in each age group i, the determined monthly fixed amounts per person by the number of months completed by the persons concerned in the creditor State in that age group. The number of months completed by the persons concerned in the creditor State shall be the sum of the calendar months in a calendar year during which the persons concerned were, because of their residence in the territory of the creditor State, eligible to receive benefits in kind in that territory at the expense of the debtor State. Those months shall be determined from an inventory kept for that purpose by the institution of the place of residence, based on documentary evidence of the entitlement of the beneficiaries supplied by the competent institution. 5. The Specialised Committee on Social Security Coordination may present a proposal containing any amendments which may prove necessary in order to ensure that the calculation of fixed amounts comes as close as possible to the actual expenditure incurred and the reductions referred to in paragraph 3 do not result in unbalanced payments or double payments for the States. 6. The Specialised Committee on Social Security Coordination shall establish the methods for determining the elements for calculating the fixed amounts referred to in this Article. Article SSCI.50 Notification of annual average costs The annual average cost per person in each age group for a specific year shall be notified to the Specialised Committee on Social Security Coordination at the latest by the end of the second year following the year in question. If the notification is not made by this deadline, the annual average cost per person which the Specialised Committee on Social Security Coordination has last determined for a previous year will be taken. SECTION 3 COMMON PROVISIONS Article SSCI.51 Procedure for reimbursement between institutions 1. Reimbursements between the States shall be made as promptly as possible. Every institution concerned shall be obliged to reimburse claims before the deadlines mentioned in this Section, as soon as it is in a position to do so. A dispute concerning a particular claim shall not hinder the reimbursement of another claim or other claims. 2. The reimbursements between the institutions of the Member States and the United Kingdom, provided for in Articles SSC.30 and SSC.36 of this Protocol, shall be made via the liaison body. There may be a separate liaison body for reimbursements under Article SSC.30 and Article SSC.36 of this Protocol. Article SSCI.52 Deadlines for the introduction and settlement of claims 1. Claims based on actual expenditure shall be introduced to the liaison body of the debtor State within 12 months of the end of the calendar half-year during which those claims were recorded in the accounts of the creditor institution. 2. Claims for fixed amounts for a calendar year shall be introduced to the liaison body of the debtor State within the 12-month period following the month during which the average costs for the year concerned were approved by the Specialised Committee on Social Security Coordination. The inventories referred to Article SSCI.49(4) shall be presented by the end of the year following the reference year. 3. In the case referred to in the second subparagraph of Article SSCI.7(5), the deadline set out in paragraphs 1 and 2 of this Article shall not start before the competent institution has been identified. 4. Claims introduced after the deadlines specified in paragraphs 1 and 2 shall not be considered. 5. The claims shall be paid to the liaison body of the creditor State referred to in Article SSCI.51, by the debtor institution within 18 months of the end of the month during which they were introduced to the liaison body of the debtor State. This does not apply to the claims which the debtor institution has rejected for a relevant reason within that period. 6. Any disputes concerning a claim shall be settled, at the latest, within 36 months following the month in which the claim was introduced. 7. The Specialised Committee on Social Security Coordination shall facilitate the final closing of accounts in cases where a settlement cannot be reached within the period set out in paragraph 6, and, upon a reasoned request by one of the parties in the dispute, shall give its opinion on a dispute within six months following the month in which the matter was referred to it. Article SSCI.53 Interest on late payments and down payments 1. From the end of the 18-month period set out in Article SSCI.52(5), interest can be charged by the creditor institution on outstanding claims, unless the debtor institution has made, within six months of the end of the month during which the claim was introduced, a down payment of at least 90 % of the total claim introduced pursuant to Article SSCI.52(1) or (2). For those parts of the claim not covered by the down payment, interest may be charged only from the end of the 36-month period set out in Article SSCI.52(6). 2. The interest shall be calculated on the basis of the reference rate applied by the financial institution designated for this purpose by the Specialised Committee on Social Security Coordination to its main refinancing operations. The reference rate applicable shall be that in force on the first day of the month on which the payment is due. 3. No liaison body shall be obliged to accept a down payment as provided for in paragraph 1. If however, a liaison body declines such an offer, the creditor institution shall no longer be entitled to charge interest on late payments related to the claims in question other than under the second sentence of paragraph 1. Article SSCI.54 Statement of Annual Accounts 1. The Partnership Council shall establish the claims situation for each calendar year on the basis of the report of the Specialised Committee on Social Security Coordination. To this end, the liaison bodies shall notify the Specialised Committee on Social Security Coordination, by the deadlines and according to the procedures laid down by the latter, of the amount of the claims introduced, settled or contested (creditor position) and the amount of claims received, settled or contested (debtor position). 2. The Partnership Council may perform any appropriate checks on the statistical and accounting data used as the basis for drawing up the annual statement of claims provided for in paragraph 1 in order, in particular, to ensure that they comply with the rules laid down under this Title. CHAPTER 2 RECOVERY OF BENEFITS PROVIDED BUT NOT DUE, RECOVERY OF PROVISIONAL PAYMENTS AND CONTRIBUTIONS, OFFSETTING AND ASSISTANCE WITH RECOVERY SECTION 1 PRINCIPLES Article SSCI.55 Common provisions For the purposes of applying Article SSC.64 of this Protocol and within the framework defined therein, the recovery of claims shall, wherever possible, be by way of offsetting either between the institutions of the Member State concerned and of the United Kingdom, or vis-à-vis the natural or legal person concerned in accordance with Articles SSCI.56 to SSCI.58 of this Annex. If it is not possible to recover all or any of the claim via this offsetting procedure, the remainder of the amount due shall be recovered in accordance with Articles SSCI.59 to SSCI.69 of this Annex. SECTION 2 OFFSETTING Article SSCI.56 Benefits received unduly 1. If the institution of a State has paid undue benefits to a person, that institution may, within the terms and limits laid down in the legislation it applies, request the institution of the State responsible for paying benefits to the person concerned to deduct the undue amount from arrears or on-going payments owed to the person concerned regardless of the social security branch under which the benefit is paid. The institution of the latter State shall deduct the amount concerned subject to the conditions and limits applying to this kind of offsetting procedure in accordance with the legislation it applies in the same way as if it had made the overpayments itself, and shall transfer the amount deducted to the institution that has paid undue benefits. 2. By way of derogation from paragraph 1, if, when awarding or reviewing benefits in respect of invalidity benefits, old-age and survivors' pensions pursuant to Chapters 3 and 4 of Title III of this Protocol, the institution of a State has paid to a person benefits of undue sum, that institution may request the institution of the State responsible for the payment of corresponding benefits to the person concerned to deduct the amount overpaid from the arrears payable to the person concerned. After the latter institution has informed the institution that has paid an undue sum of these arrears, the institution which has paid the undue sum shall within two months communicate the amount of the undue sum. If the institution which is due to pay arrears receives that communication within the deadline it shall transfer the amount deducted to the institution which has paid undue sums. If the deadline expires, that institution shall without delay pay out the arrears to the person concerned. 3. If a person has received social welfare assistance in one State during a period in which they were entitled to benefits under the legislation of another State, the body which provided the assistance may, if it is legally entitled to reclaim the benefits due to the person concerned, request the institution of any other State responsible for paying benefits in favour of the person concerned to deduct the amount of assistance paid from the amounts which that State pays to the person concerned. This provision applies mutatis mutandis to any family member of a person concerned who has received assistance in the territory of a State during a period in which the insured person was entitled to benefits under the legislation of another State in respect of that family member. The institution of a State which has paid an undue amount of assistance shall send a statement of the amount due to the institution of the other State, which shall then deduct the amount, subject to the conditions and limits laid down for this kind of offsetting procedure in accordance with the legislation it applies, and transfer the amount without delay to the institution that has paid the undue amount. Article SSCI.57 Provisionally paid benefits in cash or contributions 1. For the purposes of applying Article SSCI.6, at the latest three months after the applicable legislation has been determined or the institution responsible for paying the benefits has been identified, the institution which provisionally paid the cash benefits shall draw up a statement of the amount provisionally paid and shall send it to the institution identified as being competent. The institution identified as being competent for paying the benefits shall deduct the amount due in respect of the provisional payment from the arrears of the corresponding benefits it owes to the person concerned and shall without delay transfer the amount deducted to the institution which provisionally paid the cash benefits. If the amount of provisionally paid benefits exceeds the amount of arrears, or if arrears do not exist, the institution identified as being competent shall deduct this amount from ongoing payments subject to the conditions and limits applying to this kind of offsetting procedure under the legislation it applies, and without delay transfer the amount deducted to the institution which provisionally paid the cash benefits. 2. The institution which has provisionally received contributions from a legal or natural person shall not reimburse the amounts in question to the person who paid them until it has ascertained from the institution identified as being competent the sums due to it under Article SSCI.6(4). Upon request of the institution identified as being competent, which shall be made at the latest three months after the applicable legislation has been determined, the institution that has provisionally received contributions shall transfer them to the institution identified as being competent for that period for the purpose of settling the situation concerning the contributions owed by the legal or natural person to it. The contributions transferred shall be retroactively deemed as having been paid to the institution identified as being competent. If the amount of provisionally paid contributions exceeds the amount the legal or natural person owes to the institution identified as being competent, the institution which provisionally received contributions shall reimburse the amount in excess to the legal or natural person concerned. Article SSCI.58 Costs related to offsetting No costs are payable where the debt is recovered via the offsetting procedure provided for in Articles SSCI.56 and SSCI.57. SECTION 3 RECOVERY Article SSCI.59 Definitions and common provisions 1. For the purposes of this Section: (a) "claim" means all claims relating to contributions or to benefits paid or provided unduly, including interest, fines, administrative penalties and all other charges and costs connected with the claim in accordance with the legislation of the State making the claim; (b) "applicant party" means, in respect of each State, any institution which makes a request for information, notification or recovery concerning a claim as defined above; (c) "requested party" means, in respect of each State, any institution to which a request for information, notification or recovery can be made. 2. Requests and any related communications between the States shall, in general, be addressed via designated institutions. 3. Practical implementation measures, including, among others, those related to Article SSCI.4 and to setting a minimum threshold for the amounts for which a request for recovery can be made, shall be taken by the Specialised Committee on Social Security Coordination. Article SSCI.60 Requests for information 1. At the request of the applicant party, the requested party shall provide any information which would be useful to the applicant party in the recovery of its claim. 2. In order to obtain that information, the requested party shall make use of the powers provided for under the laws, regulations or administrative practices applying to the recovery of similar claims arising in its own State. The request for information shall indicate the name, last known address, and any other relevant information relating to the identification of the legal or natural person concerned to whom the information to be provided relates and the nature and amount of the claim in respect of which the request is made. 3. The requested party shall not be obliged to supply information: (a) which it would not be able to obtain for the purpose of recovering similar claims arising in its own territory; (b) which would disclose any commercial, industrial or professional secrets; or (c) the disclosure of which would be liable to prejudice the security of or be contrary to the public policy of a State. 4. The requested party shall inform the applicant party of the grounds for refusing a request for information. Article SSCI.61 Notification 1. The requested party shall, at the request of the applicant party, and in accordance with the rules in force for the notification of similar instruments or decisions in its own territory, notify the addressee of all instruments and decisions, including those of a judicial nature, which come from the State of the applicant party and which relate to a claim or to its recovery. 2. The request for notification shall indicate the name, address and any other relevant information relating to the identification of the addressee concerned to which the applicant party normally has access, the nature and the subject of the instrument or decision to be notified and, if necessary the name, address and any other relevant information relating to the identification of the debtor and the claim to which the instrument or decision relates, and any other useful information. 3. The requested party shall without delay inform the applicant party of the action taken on its request for notification and, particularly, of the date on which the decision or instrument was forwarded to the addressee. Article SSCI.62 Request for recovery 1. At the request of the applicant party, the requested party shall recover claims that are the subject of an instrument permitting enforcement issued by the applicant party to the extent permitted by and in accordance with the laws and administrative practices in force in the State of the requested party. 2. The applicant party may only make a request for recovery if: (a) it also provides to the requested party an official or certified copy of the instrument permitting enforcement of the claim in the State of the applicant party, except in cases where Article SSCI.64(3) is applied; (b) the claim or instrument permitting its enforcement are not contested in its own State; (c) it has, in its own State, applied appropriate recovery procedures available to it on the basis of the instrument referred to in paragraph 1, and the measures taken will not result in the payment in full of the claim; (d) the period of limitation according to its own legislation has not expired. 3. The request for recovery shall indicate: (a) the name, address and any other relevant information relating to the identification of the natural or legal person concerned or to the identification of any third party holding that person's assets; (b) the name, address and any other relevant information relating to the identification of the applicant party; (c) a reference to the instrument permitting its enforcement, issued in the State of the applicant party; (d) the nature and amount of the claim, including the principal, interest, fines, administrative penalties and all other charges and costs due indicated in the currencies of the State(s) of the applicant and requested parties; (e) the date of notification of the instrument to the addressee by the applicant party or by the requested party; (f) the date from which and the period during which enforcement is possible under the laws in force in the State of the applicant party; (g) any other relevant information. 4. The request for recovery shall also contain a declaration by the applicant party confirming that the conditions laid down in paragraph 2 have been fulfilled. 5. The applicant party shall forward to the requested party any relevant information relating to the matter which gave rise to the request for recovery, as soon as this comes to its knowledge. Article SSCI.63 Instrument permitting enforcement of recovery 1. In accordance with Article SSC.64(2) of this Protocol, the instrument permitting enforcement of the claim shall be directly recognised and treated automatically as an instrument permitting the enforcement of a claim of the State of the requested party 2. Notwithstanding paragraph 1, the instrument permitting enforcement of the claim may, where appropriate and in accordance with the provisions in force in the State of the requested party, be accepted as, recognised as, supplemented with, or replaced by an instrument authorising enforcement in the territory of that State. Within three months of the date of receipt of the request for recovery, the State(s) shall endeavour to complete the acceptance, recognition, supplementing or replacement, except in cases where the third subparagraph of this paragraph applies. States may not refuse to complete these actions where the instrument permitting enforcement is properly drawn up. The requested party shall inform the applicant party of the grounds for exceeding the three-month period. If any of these actions should give rise to a dispute in connection with the claim or the instrument permitting enforcement issued by the applicant party, Article SSCI.65 shall apply. Article SSCI.64 Payment arrangements and deadline 1. Claims shall be recovered in the currency of the State of the requested party. The entire amount of the claim that is recovered by the requested party shall be remitted by the requested party to the applicant party. 2. The requested party may, where the laws, regulations or administrative provisions in force in its own State so permit, and after consulting the applicant party, allow the debtor time to pay or authorise payment by instalment. Any interest charged by the requested party in respect of such extra time to pay shall also be remitted to the applicant party. 3. From the date on which the instrument permitting enforcement of the recovery of the claim has been directly recognised in accordance with Article SSCI.63(1) or accepted, recognised, supplemented or replaced in accordance with Article SSCI.63(2), interest shall be charged for late payment under the laws, regulations and administrative provisions in force in the State of the requested party and shall also be remitted to the applicant party. Article SSCI.65 Contestation concerning the claim or the instrument permitting enforcement of its recovery and contestation concerning enforcement measures 1. If, in the course of the recovery procedure, the claim or the instrument permitting its enforcement issued in the State of the applicant party are contested by an interested party, the action shall be brought by this party before the appropriate authorities of the State of the applicant party, in accordance with the laws in force in that State. The applicant party shall without delay notify the requested party of this action. The interested party may also inform the requested party of the action. 2. As soon as the requested party has received the notification or information referred to in paragraph 1 either from the applicant party or from the interested party, it shall suspend the enforcement procedure pending the decision of the appropriate authority in the matter, unless the applicant party requests otherwise in accordance with the second subparagraph of this paragraph. Should the requested party deem it necessary, and without prejudice to Article SSCI.68, it may take precautionary measures to guarantee recovery insofar as the laws or regulations in force in its own State allow such action for similar claims. Notwithstanding the first subparagraph, the applicant party may, in accordance with the laws, regulations and administrative practices in force in its own State, request the requested party to recover a contested claim, insofar as the relevant laws, regulations and administrative practices in force in the requested party's State allow such action. If the result of the contestation is subsequently favourable to the debtor, the applicant party shall be liable for the reimbursement of any sums recovered, together with any compensation due, in accordance with the legislation in force in the requested party's State. 3. Where the contestation concerns enforcement measures taken in the State of the requested party, the action shall be brought before the appropriate authority of that State in accordance with its laws and regulations. 4. Where the appropriate authority before which the action is brought in accordance with paragraph 1 is a judicial or administrative tribunal, the decision of that tribunal, insofar as it is favourable to the applicant party and permits recovery of the claim in the State of the applicant party, shall constitute the "instrument permitting enforcement" within the meaning of Articles SSCI.62 and SSCI.63 and the recovery of the claim shall proceed on the basis of that decision. Article SSCI.66 Limits applying to assistance 1. The requested party shall not be obliged: (a) to grant the assistance provided for in Articles SSCI.62 to SSCI.65, if recovery of the claim would, because of the situation of the debtor, create serious economic or social difficulties in the State of the requested party, insofar as the laws, regulations or administrative practices in force in the State of the requested party allow such action for similar national claims; (b) to grant the assistance provided for in Articles SSCI.60 to SSCI.65, if the initial request under Articles SSCI.60 to SSCI.62 applies to claims more than five years old, dating from the moment the instrument permitting the recovery was established in accordance with the laws, regulations or administrative practices in force in the State of the applicant party at the date of the request. However, if the claim or instrument is contested, the time limit begins from the moment that the State of the applicant party establishes that the claim or the enforcement order permitting recovery may no longer be contested. 2. The requested party shall inform the applicant party of the grounds for refusing a request for assistance. Article SSCI.67 Periods of limitation 1. Questions concerning periods of limitation shall be governed as follows: (a) by the laws in force in the State of the applicant party, insofar as they concern the claim or the instrument permitting its enforcement; and (b) by the laws in force in the State of the requested party, insofar as they concern enforcement measures in the requested State. Periods of limitation according to the laws in force in the State of the requested party shall start from the date of direct recognition or from the date of acceptance, recognition, supplementing or replacement in accordance with Article SSCI.63. 2. Steps taken in the recovery of claims by the requested party in pursuance of a request for assistance, which, if they had been carried out by the applicant party, would have had the effect of suspending or interrupting the period of limitation according to the laws in force in the State of the applicant party, shall be deemed to have been taken in the latter, insofar as that effect is concerned. Article SSCI.68 Precautionary measures Upon reasoned request by the applicant party, the requested party shall take precautionary measures to ensure recovery of a claim insofar as the laws and regulations in force in the State of the requested party so permit. For the purposes of implementing the first paragraph, the provisions and procedures laid down in Articles SSCI.62, SSCI.63, SSCI.65 and SSCI.66 apply mutatis mutandis. Article SSCI.69 Costs related to recovery 1. The requested party shall recover from the natural or legal person concerned and retain any costs linked to recovery which it incurs, in accordance with the laws and regulations of the State of the requested party that apply to similar claims. 2. Mutual assistance afforded under this Section shall, as a rule, be free of charge. However, where recovery poses a specific problem or concerns a very large amount in costs, the applicant and the requested parties may agree on reimbursement arrangements specific to the cases in question. The State of the applicant party shall remain liable to the State of the requested party for any costs and any losses incurred as a result of actions held to be unfounded, as far as either the substance of the claim or the validity of the instrument issued by the applicant party is concerned. TITLE V MISCELLANEOUS, TRANSITIONAL AND FINAL PROVISIONS Article SSCI.70 Medical examination and administrative checks 1. Without prejudice to other provisions, where a recipient or a claimant of benefits, or a member of that person's family, is staying or residing within the territory of a State other than that in which the debtor institution is located, the medical examination shall be carried out, at the request of that institution, by the institution of the beneficiary's place of stay or residence in accordance with the procedures laid down by the legislation applied by that institution. The debtor institution shall inform the institution of the place of stay or residence of any special requirements, if necessary, to be followed and points to be covered by the medical examination. 2. The institution of the place of stay or residence shall forward a report to the debtor institution that requested the medical examination. This institution shall be bound by the findings of the institution of the place of stay or residence. The debtor institution shall reserve the right to have the beneficiary examined by a doctor of its choice. However, the beneficiary may be asked to return to the State of the debtor institution only if the beneficiary is able to make the journey without prejudice to the beneficiary's health and the cost of travel and accommodation is paid for by the debtor institution. 3. Where a recipient or a claimant of benefits, or a member of that person's family, is staying or residing in the territory of a State other than that in which the debtor institution is located, the administrative check shall, at the request of the debtor institution, be performed by the institution of the beneficiary's place of stay or residence. Paragraph 2 shall also apply in this case. 4. As an exception to the principle of free-of-charge mutual administrative cooperation in Article SSC.59(3) of this Protocol, the effective amount of the expenses of the checks referred to in this Article shall be refunded to the institution which was requested to carry them out by the debtor institution which requested them. Article SSCI.71 Notifications 1. The States shall notify the Specialised Committee on Social Security Coordination of the details of the bodies and entities defined in Article SSC.1 of this Protocol and points (a) and (b) of Article SSCI.1(2) of this Annex, and of the institutions designated in accordance with this Annex. 2. The bodies specified in paragraph 1 shall be provided with an electronic identity in the form of an identification code and electronic address. 3. The Specialised Committee on Social Security Coordination shall establish the structure, content and detailed arrangements, including the common format and model, for notification of the details specified in paragraph 1. 4. For the purposes of implementing this Protocol, the United Kingdom may take part in the Electronic Exchange of Social Security Information and bear the related costs. 5. The States shall be responsible for keeping the information specified in paragraph 1 up to date. Article SSCI.72 Information The Specialised Committee on Social Security Coordination shall prepare the information needed to ensure that the parties concerned are aware of their rights and the administrative formalities required in order to assert them. This information shall, where possible, be disseminated electronically via publication online on sites accessible to the public. The Specialised Committee on Social Security Coordination shall ensure that the information is regularly updated and monitor the quality of services provided to customers. Article SSCI.73 Currency conversion For the purposes of this Protocol and this Annex, the exchange rate between two currencies shall be the reference rate published by the financial institution designated for this purpose by the Specialised Committee on Social Security Coordination. The date to be taken into account for determining the exchange rate shall be fixed by the Specialised Committee on Social Security Coordination. Article SSCI.74 Implementing provisions The Specialised Committee on Social Security Coordination may adopt further guidance on the implementation of this Protocol and of this Annex. Article SSCI.75 Interim provisions for forms and documents 1. For an interim period, the end date of which shall be agreed by the Specialised Committee on Social Security Coordination, all forms and documents issued by the competent institutions in the format used immediately before this Protocol comes into force shall be valid for the purposes of implementing this Protocol and, where appropriate, shall continue to be used for the exchange of information between competent institutions. All such forms and documents issued before and during that interim period shall be valid until their expiry or cancellation. 2. The forms and documents valid in accordance with paragraph 1 include: (a) European Health Insurance Cards issued on behalf of the United Kingdom, which shall be valid entitlement documents for the purposes of Article SSC.17 and Article SSC.25(1) of this Protocol and Article SSCI.22 of this Annex; and (b) portable documents which certify a person's social security situation as required to give effect to this Protocol. Appendix SSCI-1 ADMINISTRATIVE ARRANGEMENTS BETWEEN TWO OR MORE STATES (referred to in Article SSCI.8 of this Annex) BELGIUM — UNITED KINGDOM The Exchange of Letters of 4 May and 14 June 1976 regarding Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs of administrative checks and medical examinations) The Exchange of Letters of 18 January and 14 March 1977 regarding Article 36(3) of Regulation (EEC) No 1408/71 (arrangement for reimbursement or waiving of reimbursement of the costs of benefits in kind provided under the terms of Chapter 1 of Title III of Regulation (EEC) No 1408/71) as amended by the Exchange of Letters of 4 May and 23 July 1982 (agreement for reimbursement of costs incurred under Article 22(1)(a) of Regulation (EEC) No 1408/71) DENMARK — UNITED KINGDOM The Exchange of Letters of 30 March and 19 April 1977 as modified by an Exchange of Letters of 8 November 1989 and of 10 January 1990 on agreement of waiving of reimbursement of the costs of benefits in kind and administrative checks and medical examinations ESTONIA — UNITED KINGDOM The Arrangement finalised on 29 March 2006 between the Competent Authorities of the Republic of Estonia and of the United Kingdom under Article 36(3) and 63(3) of Regulation (EEC) No 1408/71 establishing other methods of reimbursement of the costs of benefits in kind provided under Regulation (EC) No 883/2004 by both countries with effect from 1 May 2004 FINLAND — UNITED KINGDOM The Exchange of Letters 1 and 20 June 1995 concerning Article 36(3) and 63(3) of Regulation (EEC) No 1408/71 (reimbursement or waiving of reimbursement of the cost of benefits in kind) and Article 105(2) of Regulation (EEC) 574/72 (waiving of reimbursement of the cost of administrative checks and medical examinations) FRANCE — UNITED KINGDOM The Exchange of Letters of 25 March and 28 April 1997 regarding Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs of administrative checks and medical examinations) The Agreement of 8 December 1998 on the specific methods of determining the amounts to be reimbursed for benefits in kind pursuant to Regulations (EEC) No 1408/71 and (EEC) No 574/72 HUNGARY — UNITED KINGDOM The Arrangement finalised on 1 November 2005 between the Competent Authorities of the Republic of Hungary and of the United Kingdom under Article 35(3) and 41(2) of Regulation (EEC) No 883/2004 establishing other methods of reimbursement of the costs of benefits in kind provided under that Regulation by both countries with effect from 1 May 2004 IRELAND — UNITED KINGDOM The Exchange of Letters of 9 July 1975 regarding Article 36(3) and 63(3) of Regulation (EEC) No 1408/71 (arrangement for reimbursement or waiving of reimbursement of the costs of benefits in kind provided under the terms of Chapter 1 or 4 of Title III of Regulation (EEC) No 1408/71) and Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs of administrative checks and medical examinations) ITALY — UNITED KINGDOM The Arrangement signed on 15 December 2005 between the Competent Authorities of the Italian Republic and of the United Kingdom under Article 36(3) and 63(3) of Regulation (EEC) No 1408/71 establishing other methods of reimbursement of the costs of benefits in kind provided under Regulation (EC) No 883/2004 by both countries with effect from 1 January 2005 LUXEMBOURG — UNITED KINGDOM The Exchange of Letters of 18 December 1975 and 20 January 1976 regarding Article 105(2) of Regulation (EEC) No 574/72 (waiving of reimbursement of the costs entailed in administrative checks and medical examinations referred to in Article 105 of Regulation (EEC) No 574/72) MALTA — UNITED KINGDOM The Arrangement finalised on 17 January 2007 between the Competent Authorities of Malta and of the United Kingdom under Article 35(3) and 41(2) of Regulation (EEC) No 883/2004 establishing other methods of reimbursement of the costs of benefits in kind provided under that Regulation by both countries with effect from 1 May 2004 NETHERLANDS — UNITED KINGDOM The second sentence of Article 3 of the Administrative Arrangement of 12 June 1956 on the implementation of the Convention of 11 August 1954 PORTUGAL — UNITED KINGDOM The Arrangement of 8 June 2004 establishing other methods of reimbursement of the costs of benefits in kind provided by both countries with effect from 1 January 2003 SPAIN — UNITED KINGDOM The Agreement of 18 June 1999 on the reimbursement of costs for benefits in kind granted pursuant to the provisions of Regulations (EEC) No 1408/71 and (EEC) No 574/72 SWEDEN — UNITED KINGDOM The Arrangement of 15 April 1997 concerning Article 36(3) and Article 63(3) of Regulation (EEC) No 1408/71 (reimbursement or waiving of reimbursement of the cost of benefits in kind) and Article 105(2) of Regulation (EEC) No 574/72 (waiving of refunds of the costs of administrative checks and medical examinations) Appendix SSCI-2 ENTITLEMENT DOCUMENT (Article SSC.17 and Article SSC.25(1) of this Protocol and Article SSCI.22 of this Annex) 1. Entitlement documents issued for the purposes of Article SSC.17 and Article SSC.25(1) of this Protocol by the competent institutions of Member States shall comply with Decision No S2 of 12 June 2009 of the Administrative Commission concerning the technical specifications of the European Health Insurance Card. 2. Entitlement documents issued for the purposes of Article SSC.17 and Article SSC.25(1) by the competent institutions of the United Kingdom shall contain the following data: (a) surname and forename of the document holder; (b) personal identification number of the document holder; (c) date of birth of the document holder; (d) expiry date of the document; (e) the code "UK" in lieu of the ISO code of the United Kingdom; (f) identification number and acronym of the United Kingdom institution issuing the document; (g) logical number of the document; (h) in the case of a provisional document, the date of issue and date of delivery of the document, and the signature and stamp of the United Kingdom institution. 3. The technical specifications of entitlement documents issued by the United Kingdom shall be notified without delay to the Specialised Committee on Social Security Coordination in order to facilitate the acceptance of the respective documents by institutions of the Member States providing the benefits in kind. BENEFITS IN KIND REQUIRING PRIOR AGREEMENT (Article SSC.17 and Article SSC.25(1) of this Protocol) 1. The benefits in kind to be provided under Article SSC.17 and Article SSC.25(1) of this Protocol shall include benefits provided in conjunction with chronic or existing illnesses as well as in conjunction with pregnancy and childbirth. 2. Benefits in kind, including those in conjunction with chronic or existing illnesses or in conjunction with childbirth, are not covered by these provisions when the objective of the stay in another State is to receive these treatments. 3. Any vital medical treatment which is only accessible in a specialised medical unit or given by specialised staff or equipment must be subject to a prior agreement between the insured person and the unit providing the treatment in order to ensure that the treatment is available during the insured person's stay in a State other than the competent State or the one of residence. 4. A non-exhaustive list of the treatments which fulfil these criteria is the following: (a) kidney dialysis; (b) oxygen therapy; (c) special asthma treatment; (d) echocardiography in case of chronic autoimmune diseases; (e) chemotherapy. Appendix SSCI-3 STATES CLAIMING THE REIMBURSEMENT OF THE COST OF BENEFITS IN KIND ON THE BASIS OF FIXED AMOUNTS (referred to in Article SSCI.48(1) of this Annex) IRELAND SPAIN CYPRUS PORTUGAL SWEDEN UNITED KINGDOM ANNEX SSC-8 TRANSITIONAL PROVISIONS REGARDING THE APPLICATION OF ARTICLE SSC.11 MEMBER STATES

EU-UK Trade and Cooperation agreement EU-UK Trade and Cooperation agreement SUMMARY OF: Trade and cooperation agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information Decision (EU) 2020/2252 on the signing, on behalf of the Union, of the EU-UK Trade and Cooperation Agreement and of the Agreement concerning security procedures for exchanging and protecting classified information Decision (Euratom) 2020/2253 approving the conclusion of the Agreement between the Government of the United Kingdom of Great Britain and Northern Ireland and the European Atomic Energy Community for Cooperation on the Safe and Peaceful Uses of Nuclear Energy and of the Trade and Cooperation Agreement Declarations referred to in the Council Decision on the conclusion, on behalf of the Union, of the Trade and Cooperation Agreement and of the Agreement concerning security procedures for exchanging and protecting classified information Decision (EU) 2021/689 on the conclusion, on behalf of the Union, of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, and of the Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information Notice concerning the entry into force of the EU-UK Trade and Cooperation Agreement and of the Agreement concerning security procedures for exchanging and protecting classified information WHAT IS THE AIM OF THE DECISIONS, THE AGREEMENTS AND THE DECLARATIONS? The decisions cover the signing and application of the free trade agreement between the United Kingdom and the EU and the EU Member States. The agreement is designed to go further than a traditional free trade agreement and provide a solid basis to preserve friendship and cooperation in the future. It reflects the fact that the UK is leaving the EU’s system of common rules, supervision and enforcement mechanisms, and will no longer enjoy the benefits of the EU’s single market. The declarations set out political decisions agreed between the 2 parties on a number of specific issues and policy areas. KEY POINTS The agreement is divided into 7 parts followed by 3 protocols and more than 600 pages of annexes. Part 1: Common and institutional rules This part lays out the aims of the agreement, rules for supplementary agreements between the parties and sets out the institutional structure, including the Partnership Council committees and working groups designed to ensure the proper functioning of the agreement. Part 2: Trade, transport, fisheries and other arrangements This part is subdivided into several headings: 1.Trade — this heading covers a number of areas including: trade in goods — including an agreement for zero tariffs or quotas on goods traded, mutual recognition of trusted traders programmes, and rules of origin; services and investments — includes an agreement for equal treatment for EU service suppliers and investors in the UK and vice versa; digital trade — includes the removal of unjustified barriers to digital trade, including prohibition of data localisation requirements, while respecting data protection rules; energy — includes guarantees on security of energy supply, offshore energy cooperation in the North Sea, enforceable commitments towards the Paris Agreement and non-regression on climate change and carbon pricing; a level playing field for open and fair competition and sustainable development. 2. Aviation — the agreement includes: unlimited point-to-point traffic between EU and UK airports; cooperation on aviation safety, security and air traffic management; rules on ground-handling and slots (non-discrimination and access), and passenger rights. 3. Road transport — the agreement includes: unlimited point-to-point access for hauliers carrying loads between the EU and the UK and full transit rights across each other’s territories; rules on working conditions, road safety, fair competition, and a level playing field regarding the environment, social issues and competition. 4. Social security coordination and visas for short term visits — the agreement includes: coordination of some social security benefits (old-age and survivors’ pensions, pre-retirement, healthcare, maternity and paternity, accidents at work) making it easier to work abroad and not lose rights; non-discrimination clause ensures equal treatment of EU citizens for short-term visas. 5. Fisheries — the agreement includes: new arrangements ensure sustainable management of shared fish stocks in EU and UK waters, respecting both parties’ rights and obligations as independent coastal states; a transition period of five and a half years during which reciprocal access rights to fish in each other’s waters remain unchanged, with a gradual transfer of EU quotas to the UK. Part 3: Law enforcement and judicial cooperation in criminal matters The agreement ensures that the parties will work together in a number of ways including: continued cooperation between UK, Europol and Eurojust; arrangements for close cooperation between national police and judicial authorities of the UK and EU Member States, including on surrender; mechanisms for swift exchanges of Passenger Name Record (PNR) data, of DNA, fingerprints and vehicle registration data (Prüm), and of criminal record information; cooperation on money-laundering and terrorist financing. Part 4: Thematic cooperation The agreement ensures cooperation on certain other issues including: cross-border health security threats; sharing classified information and best practice in the field of cyber security, including the opportunity for the UK to take part in the EU Agency for Cyber Security (ENISA). Part 5: Participation in EU programmes, sound financial management and financial provisions The UK will take part in 5 EU programmes open to non-EU country participation (subject to its financial contribution): Horizon Europe (research and innovation); Euratom Research and Training programme; ITER (fusion test facility); Copernicus (Earth monitoring system); Access to EU satellite surveillance & tracking (SST) services. Part 6: Dispute settlement and horizontal rules If a solution to a disagreement cannot be found between the parties, an independent arbitration tribunal can be set up to settle the matter through a binding ruling. This dispute settlement mechanism covers most areas of the agreement, including the level playing field and fisheries. The mechanism is accompanied by enforcement and safeguard mechanisms including the possibility to suspend market access commitments, e.g. by reintroducing tariffs and/or quotas in the affected area. Both parties will also be able to cross-retaliate* if the other does not comply with a ruling of an independent arbitration tribunal. Any substantial breach of obligations deemed ‘essential elements’ (fighting climate change, respecting democratic values and fundamental rights, or non-proliferation) can trigger the suspension or termination of all or part of the entire agreement. Part 7: Final provisions The agreement does not apply to Gibraltar nor to British overseas territories. The agreement and any supplementary agreements will be reviewed every 5 years. Annexes and protocols There are numerous annexes to the agreement covering issues such as: rules of procedure of the Partnership Council and committees; rules of origin; motor vehicles, equipment and parts; medical products; rules for authorised economic operators; guidelines for the recognition of professional qualifications. The are 3 protocols attached to the agreement: Protocol on administrative cooperation and combating fraud in the field of value added tax and for mutual assistance for the recovery of claims related to tax and duties — this protocol sets out the rules and procedures for cooperation in this field. Protocol on mutual administrative assistance in customs matters — this protocol is designed to enable the two parties to assist each other in ensuring the correct application of customs legislation, in particular by preventing, investigating and combating operations in breach of that legislation. Protocol on social security coordination — this protocol sets out the rules for coordination on: sickness benefits;maternity and paternity benefits;invalidity benefits;old-age benefits. Declarations The declarations cover a wide range of issues including: financial service regulatory cooperation; countering harmful tax regimes; monetary policy and subsidy control; road hauliers; asylum and returns; various aspects of law enforcement and judicial cooperation on criminal matters; exchange and protection of classified information; UK participation in EU programmes and access to programme services; a draft protocol on the programmes and activities in which the UK will participate. FROM WHEN DO THE DECISIONS AND AGREEMENT APPLY? Decisions (EU) 2020/2252 and (Euratom) 2020/2253 have applied since 29 December 2020. Following the consent of the European Parliament on 27 April 2021 and the Council decision on 29 April 2021, the EU-UK Trade and Cooperation Agreement and the Agreement on security of information entered into force on 1 May 2021. BACKGROUND The Trade and Cooperation Agreement follows on from the Withdrawal Agreement agreed between the UK and the EU which entered into force on 1 February 2020. The Withdrawal Agreement covered issues such as: citizens’ rights — both of EU citizens living in the UK and vice versa; separation issues — steps to ensure an orderly withdrawal of the UK; a transition period from 1 February to 31 December 2020 — to enable a Trade and Cooperation Agreement to be negotiated, and during which the UK was treated in most respects as a Member State; the financial settlement — ensuring that the UK honoured its financial obligations as a Member State. KEY TERMS Cross-retaliation: retaliation by means such as tariffs, in one sector of trade, such as agriculture, to counter unfair actions or violations of agreements affecting trade in another sector. MAIN DOCUMENTS Trade and cooperation agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part (OJ L 149, 30.4.2021, pp. 10-2539) Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information (OJ L 149, 30.4.2021, pp. 2540-2548) Council Decision (EU) 2020/2252 of 29 December 2020 on the signing, on behalf of the Union, and on provisional application of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, and of the Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information (OJ L 444, 31.12.2020, pp. 2-10) Council Decision (Euratom) 2020/2253 of 29 December 2020 approving the conclusion, by the European Commission, of the Agreement between the Government of the United Kingdom of Great Britain and Northern Ireland and the European Atomic Energy Community for Cooperation on the Safe and Peaceful Uses of Nuclear Energy and the conclusion, by the European Commission, on behalf of the European Atomic Energy Community, of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part (OJ L 444, 31.12.2020, pp. 11-13) Declarations referred to in the Council Decision on the conclusion, on behalf of the Union, of the Trade and Cooperation Agreement and of the Agreement concerning security procedures for exchanging and protecting classified information (OJ L 149, 30.4.2021, pp. 2549-2559) Council Decision (EU) 2021/689 of 29 April 2021 on the conclusion, on behalf of the Union, of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, and of the Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information (OJ L 149, 30.4.2021, pp. 2-9) Notice concerning the entry into force of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, and of the Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information (OJ L 149, 30.4.2021, p. 2560) RELATED DOCUMENT Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (OJ C 384I, 12.11.2019, pp. 1-177) last update 27.05.2021

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17.12.2018 EN Official Journal of the European Union L 321/36 DIRECTIVE (EU) 2018/1972 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 establishing the European Electronic Communications Code (Recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Directives 2002/19/EC (4), 2002/20/EC (5), 2002/21/EC (6) and 2002/22/EC (7) of the European Parliament and of the Council have been substantially amended. Since further amendments are to be made, those Directives should be recast in the interests of clarity. (2) The functioning of the five Directives which are part of the existing regulatory framework for electronic communications networks and services, namely Directives 2002/19/EC, 2002/20/EC, 2002/21/EC and 2002/22/EC, and Directive 2002/58/EC of the European Parliament and of the Council (8), is subject to periodic review by the Commission, with a view, in particular, to determining the need for modification in light of technological and market developments. (3) In its communication or 6 May 2015 setting out a Digital Single Market Strategy for Europe, the Commission stated that its review of the telecommunications framework would focus on measures that aim to provide incentives for investment in high-speed broadband networks, bring a more consistent internal market approach to radio spectrum policy and management, deliver conditions for a true internal market by tackling regulatory fragmentation, ensure effective protection of consumers, a level playing field for all market players and consistent application of the rules, as well as provide a more effective regulatory institutional framework. (4) This Directive is part of a ‘Regulatory Fitness’ (REFIT) exercise, the scope of which includes four Directives, namely 2002/19/EC, 2002/20/EC, 2002/21/EC and 2002/22/EC, and Regulation (EC) No 1211/2009 of the European Parliament and of the Council (9). Each of those Directives contains measures applicable to providers of electronic communications networks and of electronic communications services, consistently with the regulatory history of the sector under which undertakings were vertically integrated, namely, active in both the provision of networks and of services. The review offers an occasion to recast the four Directives in order to simplify the current structure with a view to reinforcing its consistency and accessibility in relation to the REFIT objective. It also offers the possibility to adapt the structure to the new market reality, where the provision of communications services is no longer necessarily bundled to the provision of a network. As provided in the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts (10), recasting consists in the adoption of a new legal act which incorporates in a single text both the substantive amendments which it makes to an earlier act and the unchanged provisions of that act. The proposal for recasting deals with the substantive amendments which it makes to an earlier act, and on a secondary level, includes the codification of the unchanged provisions of the earlier act with those substantive amendments. (5) This Directive creates a legal framework to ensure freedom to provide electronic communications networks and services, subject only to the conditions laid down in this Directive and to any restrictions in accordance with Article 52(1) of the Treaty on the Functioning of the European Union (TFEU), in particular measures regarding public policy, public security and public health, and consistent with Article 52(1) of the Charter of Fundamental Rights of the European Union (the ‘Charter’). (6) This Directive is without prejudice to the possibility for each Member State to take the necessary measures to ensure the protection of its essential security interests, to safeguard public policy and public security, and to permit the investigation, detection and prosecution of criminal offences, taking into account that any limitation to the exercise of the rights and freedoms recognised by the Charter, in particular in Articles 7, 8 and 11 thereof, such as limitations regarding the processing of data, are to be provided for by law, respect the essence of those rights and freedoms and be subject to the principle of proportionality, in accordance with Article 52(1) of the Charter. (7) The convergence of the telecommunications, media and information technology sectors means that all electronic communications networks and services should be covered to the extent possible by a single European electronic communications code established by means of a single Directive, with the exception of matters better dealt with through directly applicable rules established by means of regulations. It is necessary to separate the regulation of electronic communications networks and services from the regulation of content. Therefore, this Directive does not cover the content of services delivered over electronic communications networks using electronic communications services, such as broadcasting content, financial services and certain information society services, and is without prejudice to measures taken at Union or national level in respect of such services, in accordance with Union law, in order to promote cultural and linguistic diversity and to ensure the defence of media pluralism. The content of television programmes is covered by Directive 2010/13/EU of the European Parliament and of the Council (11). The regulation of audiovisual policy and content aims at achieving general interest objectives, such as freedom of expression, media pluralism, impartiality, cultural and linguistic diversity, social inclusion, consumer protection and the protection of minors. The separation between the regulation of electronic communications and the regulation of content does not affect the taking into account of the links existing between them, in particular in order to guarantee media pluralism, cultural diversity and consumer protection. Within the limits of their competences, competent authorities should contribute to ensuring the implementation of policies aiming to promote those objectives. (8) This Directive does not affect the application to radio equipment of Directive 2014/53/EU of the European Parliament and of the Council (12), but does cover car radio and consumer radio receivers, and consumer digital television equipment. (9) In order to allow national regulatory and other competent authorities to meet the objectives set out in this Directive, in particular concerning end-to-end interoperability, the scope of the Directive should cover certain aspects of radio equipment as defined in Directive 2014/53/EU and consumer equipment used for digital television, in order to facilitate access for end-users with disabilities. It is important for national regulatory and other competent authorities to encourage network operators and equipment manufacturers to cooperate in order to facilitate access by end-users with disabilities to electronic communications services. The non-exclusive use of radio spectrum for the self-use of radio terminal equipment, although not related to an economic activity, should also be the subject of this Directive in order to ensure a coordinated approach with regard to their authorisation regime. (10) Certain electronic communications services under this Directive could also fall within the scope of the definition of ‘information society service’ set out in Article 1 of Directive (EU) 2015/1535 of the European Parliament and of the Council (13). The provisions of that Directive that govern information society services apply to those electronic communications services to the extent that this Directive or other Union legal acts do not contain more specific provisions applicable to electronic communications services. However, electronic communications services such as voice telephony, messaging services and electronic mail services are covered by this Directive. The same undertaking, for example an internet service provider, can offer both an electronic communications service, such as access to the internet, and services not covered by this Directive, such as the provision of web-based and not communications-related content. (11) The same undertaking, for example a cable operator, can offer both an electronic communications service, such as the conveyance of television signals, and services not covered under this Directive, such as the commercialisation of an offer of sound or television broadcasting content services, and therefore additional obligations can be imposed on such an undertaking in relation to its activity as a content provider or distributor, in accordance with provisions other than those of this Directive, without prejudice to the conditions laid in an annex to this Directive. (12) The regulatory framework should cover the use of radio spectrum by all electronic communications networks, including the emerging self-use of radio spectrum by new types of networks consisting exclusively of autonomous systems of mobile radio equipment that is connected via wireless links without a central management or centralised network operator, and not necessarily within the exercise of any specific economic activity. In the developing 5G wireless communications environment, such networks are likely to develop in particular outside buildings and on the roads, for transport, energy, research and development, eHealth, public protection and disaster relief, the Internet of Things, machine-to-machine and connected cars. As a result, the application by Member States, based on Article 7 of Directive 2014/53/EU, of additional national requirements regarding the putting into service or use of such radio equipment, or both, in relation to the effective and efficient use of radio spectrum and avoidance of harmful interference should reflect the principles of the internal market. (13) The requirements concerning the capabilities of electronic communications networks are constantly increasing. While in the past the focus was mainly on growing bandwidth available overall and to each individual user, other parameters such as latency, availability and reliability are becoming increasingly important. The current response towards that demand is to bring optical fibre closer and closer to the user, and future ‘very high capacity networks’ require performance parameters which are equivalent to those that a network based on optical fibre elements at least up to the distribution point at the serving location can deliver. In the case of fixed-line connection, this corresponds to network performance equivalent to that achievable by an optical fibre installation up to a multi-dwelling building, considered to be the serving location. In the case of wireless connection, this corresponds to network performance similar to that achievable based on an optical fibre installation up to the base station, considered to be the serving location. Variations in end-users’ experience which are due to the different characteristics of the medium by which the network ultimately connects with the network termination point should not be taken into account for the purposes of establishing whether a wireless network could be considered as providing similar network performance. In accordance with the principle of technology neutrality, other technologies and transmission media should not be excluded, where they compare with that baseline scenario in terms of their capabilities. The roll-out of such ‘very high capacity networks’ is likely to further increase the capabilities of networks and pave the way for the roll-out of future wireless network generations based on enhanced air interfaces and a more densified network architecture. (14) Definitions need to be adjusted to ensure that they are in line with the principle of technology neutrality and to keep pace with technological development, including new forms of network management such as through software emulation or software-defined networks. Technological and market evolution has brought networks to move to internet protocol (IP) technology, and enabled end-users to choose between a range of competing voice service providers. Therefore, the term ‘publicly available telephone service’, which is exclusively used in Directive 2002/22/EC and widely perceived as referring to traditional analogue telephone services, should be replaced by the more current and technological neutral term ‘voice communications service’. Conditions for the provision of a service should be separated from the actual definitional elements of a voice communications service, namely, a publicly available electronic communications service for originating and receiving, directly or indirectly, national or national and international calls through a number or numbers in a national or international numbering plan, whether such a service is based on circuit switching or packet switching technology. It is the nature of such a service that it is bidirectional, enabling both parties to communicate. A service which does not fulfil all those conditions, such as for example a ‘click-through’ application on a customer service website, is not such a service. Voice communications services also include means of communication specifically intended for end-users with disabilities using text relay or total conversation services. (15) The services used for communications purposes, and the technical means of their delivery, have evolved considerably. End-users increasingly substitute traditional voice telephony, text messages (SMS) and electronic mail conveyance services by functionally equivalent online services such as Voice over IP, messaging services and web-based e-mail services. In order to ensure that end-users and their rights are effectively and equally protected when using functionally equivalent services, a future-oriented definition of electronic communications services should not be purely based on technical parameters but rather build on a functional approach. The scope of necessary regulation should be appropriate to achieve its public interest objectives. While ‘conveyance of signals’ remains an important parameter for determining the services falling into the scope of this Directive, the definition should cover also other services that enable communication. From an end-user’s perspective it is not relevant whether a provider conveys signals itself or whether the communication is delivered via an internet access service. The definition of electronic communications services should therefore contain three types of services which may partly overlap, that is to say internet access services as defined in point (2) of Article 2 of Regulation (EU) 2015/2120 of the European Parliament and of the Council (14), interpersonal communications services as defined in this Directive, and services consisting wholly or mainly in the conveyance of signals. The definition of electronic communications service should eliminate ambiguities observed in the implementation of the definition as it existed prior to the adoption of this Directive and allow a calibrated provision-by-provision application of the specific rights and obligations contained in the framework to the different types of services. The processing of personal data by electronic communications services, whether as remuneration or otherwise, should comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (15). (16) In order to fall within the scope of the definition of electronic communications service, a service needs to be provided normally in exchange for remuneration. In the digital economy, market participants increasingly consider information about users as having a monetary value. Electronic communications services are often supplied to the end-user not only for money, but increasingly and in particular for the provision of personal data or other data. The concept of remuneration should therefore encompass situations where the provider of a service requests and the end-user knowingly provides personal data within the meaning of Regulation (EU) 2016/679 or other data directly or indirectly to the provider. It should also encompass situations where the end-user allows access to information without actively supplying it, such as personal data, including the IP address, or other automatically generated information, such as information collected and transmitted by a cookie. In line with the case-law of the Court of Justice of the European Union (Court of Justice) on Article 57 TFEU (16), remuneration also exists within the meaning of the TFEU if the service provider is paid by a third party and not by the service recipient. The concept of remuneration should therefore also encompass situations in which the end-user is exposed to advertisements as a condition for gaining access to the service, or situations in which the service provider monetises personal data it has collected in accordance with Regulation (EU) 2016/679. (17) Interpersonal communications services are services that enable interpersonal and interactive exchange of information, covering services like traditional voice calls between two individuals but also all types of emails, messaging services, or group chats. Interpersonal communications services only cover communications between a finite, that is to say not potentially unlimited, number of natural persons, which is determined by the sender of the communication. Communications involving legal persons should fall within the scope of the definition where natural persons act on behalf of those legal persons or are involved at least on one side of the communication. Interactive communication entails that the service allows the recipient of the information to respond. Services which do not meet those requirements, such as linear broadcasting, video on demand, websites, social networks, blogs, or exchange of information between machines, should not be considered to be interpersonal communications services. In exceptional circumstances a service should not be considered to be an interpersonal communications service if the interpersonal and interactive communication facility is a minor and purely ancillary feature to another service and for objective technical reasons cannot be used without that principal service, and its integration is not a means to circumvent the applicability of the rules governing electronic communications services. As elements of an exemption from the definition the terms ‘minor’ and ‘purely ancillary’ should be interpreted narrowly and from an objective end-user’s perspective. An interpersonal communications feature could be considered to be minor where its objective utility for an end-user is very limited and where it is in reality barely used by end-users. An example of a feature that could be considered to fall outside the scope of the definition of interpersonal communications services might be, in principle, a communication channel in online games, depending on the features of the communication facility of the service. (18) Interpersonal communications services using numbers from national and international numbering plans connect with publicly assigned numbering resources. Those number-based interpersonal communications services comprise both services to which end-users numbers are assigned for the purpose of ensuring end-to-end connectivity and services enabling end-users to reach persons to whom such numbers have been assigned. The mere use of a number as an identifier should not be considered to be equivalent to the use of a number to connect with publicly assigned numbers and should therefore, in itself, not be considered to be sufficient to qualify a service as a number-based interpersonal communications service. Number-independent interpersonal communications services should be subject to obligations only where public interests require that specific regulatory obligations apply to all types of interpersonal communications services, regardless of whether they use numbers for the provision of their service. It is justified to treat number-based interpersonal communications services differently, as they participate in, and hence also benefit from, a publicly assured interoperable ecosystem. (19) The network termination point represents a boundary for regulatory purposes between the regulatory framework for electronic communications networks and services and the regulation of telecommunications terminal equipment. Defining the location of the network termination point is the responsibility of the national regulatory authority. In light of the practice of national regulatory authorities, and given the variety of fixed and wireless topologies, the Body of European Regulators for Electronic Communications (‘BEREC’) should, in close cooperation with the Commission, adopt guidelines on common approaches to the identification of the network termination point, in accordance with this Directive, in various concrete circumstances. (20) Technical developments make it possible for end-users to access emergency services not only by voice calls but also by other interpersonal communications services. The concept of emergency communication should therefore cover all interpersonal communications services that allow such emergency services access. It builds on the emergency system elements already enshrined in Union law, namely a public safety answering point (‘PSAP’) and a most appropriate PSAP as defined in Regulation (EU) 2015/758 of the European Parliament and of the Council (17), and on emergency services as defined in Commission Delegated Regulation (EU) No 305/2013 (18). (21) National regulatory and other competent authorities should have a harmonised set of objectives and principles to underpin their work, and should, where necessary, coordinate their actions with the authorities of other Member States and with BEREC in carrying out their tasks under this regulatory framework. (22) The tasks assigned to competent authorities by this Directive contribute to the fulfilment of broader policies in the areas of culture, employment, the environment, social cohesion and town and country planning. (23) The regulatory framework should, in addition to the existing three primary objectives of promoting competition, the internal market and end-user interests, pursue an additional connectivity objective, articulated in terms of outcomes: widespread access to and take-up of very high capacity networks for all citizens of the Union and Union businesses on the basis of reasonable price and choice, effective and fair competition, open innovation, efficient use of radio spectrum, common rules and predictable regulatory approaches in the internal market and the necessary sector-specific rules to safeguard the interests of citizens of the Union. For the Member States, the national regulatory and other competent authorities and the stakeholders, that connectivity objective translates, on the one hand, into aiming for the highest capacity networks and services economically sustainable in a given area, and, on the other, into pursuing territorial cohesion, in the sense of convergence in capacity available in different areas. (24) Progress towards the achievement of the general objectives of this Directive should be supported by a robust system of continuous assessment and benchmarking by the Commission of Member States with respect to the availability of very high capacity networks in all major socio-economic drivers such as schools, transport hubs and major providers of public services, and highly digitised businesses, the availability of uninterrupted 5G coverage for urban areas and major terrestrial transport paths, and the availability to all households in each Member State of electronic communications networks which are capable of providing at least 100 Mbps, and which are promptly upgradeable to gigabit speeds. To that end, the Commission should continue monitoring the performance of Member States, including, by way of an example, indexes that summarise relevant indicators on the Union’s digital performance and track the evolution of Member States in digital competitiveness, such as the Digital Economy and Society Index, and, where necessary, establish new methods and new objective, concrete and quantifiable criteria for benchmarking the effectiveness of Member States. (25) The principle that Member States should apply Union law in a technologically neutral fashion, that is to say that a national regulatory or other competent authority should neither impose nor discriminate in favour of the use of a particular type of technology, does not preclude the taking of proportionate steps to promote certain specific services where justified in order to attain the objectives of the regulatory framework, for example digital television as a means for increasing radio spectrum efficiency. Furthermore, that principle does not preclude taking into account that certain transmission media have physical characteristics and architectural features that can be superior in terms of quality of service, capacity, maintenance cost, energy efficiency, management flexibility, reliability, robustness and scalability, and, ultimately, performance, which can be reflected in actions taken with a view to pursuing the various regulatory objectives. (26) Both efficient investment and competition should be encouraged in tandem, in order to increase economic growth, innovation and consumer choice. (27) Competition can best be fostered through an economically efficient level of investment in new and existing infrastructure, complemented by regulation, where necessary, to achieve effective competition in retail services. An efficient level of infrastructure-based competition is the extent of infrastructure duplication at which investors can reasonably be expected to make a fair return based on reasonable expectations about the evolution of market shares. (28) It is necessary to give appropriate incentives for investment in new very high capacity networks that support innovation in content-rich internet services and strengthen the international competitiveness of the Union. Such networks have enormous potential to deliver benefits to consumers and businesses across the Union. It is therefore vital to promote sustainable investment in the development of those new networks, while safeguarding competition, as bottlenecks and barriers to entry remain at the infrastructure level, and boosting consumer choice through regulatory predictability and consistency. (29) This Directive aims to progressively reduce ex ante sector-specific rules as competition in the markets develops and, ultimately, to ensure that electronic communications are governed only by competition law. Considering that the markets for electronic communications have shown strong competitive dynamics in recent years, it is essential that ex ante regulatory obligations are imposed only where there is no effective and sustainable competition on the markets concerned. The objective of ex ante regulatory intervention is to produce benefits for end-users by making retail markets effectively competitive on a sustainable basis. Obligations at wholesale level should be imposed where otherwise one or more retail markets are not likely to become effectively competitive in the absence of those obligations. It is likely that national regulatory authorities are gradually, through the process of market analysis, able to find retail markets to be competitive even in the absence of wholesale regulation, especially taking into account expected improvements in innovation and competition. In such a case, the national regulatory authority should conclude that regulation is no longer needed at wholesale level, and assess the corresponding relevant wholesale market with a view to withdrawing ex ante regulation. In doing so, the national regulatory authority should take into account any leverage effects between wholesale and related retail markets which might require the removal of barriers to entry at the infrastructure level in order to ensure long-term competition at the retail level. (30) Electronic communications are becoming essential for an increasing number of sectors. The Internet of Things is an illustration of how the radio signal conveyance underpinning electronic communications continues to evolve and shape societal and business reality. To derive the greatest benefit from those developments, the introduction and accommodation of new wireless communications technologies and applications in radio spectrum management is essential. As other technologies and applications relying on radio spectrum are equally subject to growing demand, and can be enhanced by integrating or combining them with electronic communications, radio spectrum management should adopt, where appropriate, a cross-sectorial approach to improve the efficient use of radio spectrum. (31) Strategic planning, coordination and, where appropriate, harmonisation at Union level can help ensure that radio spectrum users derive the full benefits of the internal market and that Union interests can be effectively defended globally. For those purposes it should be possible to adopt multiannual radio spectrum policy programmes, where appropriate. The first such programme was established by Decision No 243/2012/EU of the European Parliament and of the Council (19), setting out policy orientations and objectives for the strategic planning and harmonisation of the use of radio spectrum in the Union. It should be possible for those policy orientations and objectives to refer to the availability and efficient use of radio spectrum necessary for the establishment and functioning of the internal market, in accordance with this Directive. (32) National borders are increasingly irrelevant in determining optimal radio spectrum use. Undue fragmentation amongst national policies result in increased costs and lost market opportunities for radio spectrum users and slows down innovation to the detriment of the proper functioning of the internal market and prejudice to consumers and the economy as a whole. (33) The radio spectrum management provisions of this Directive should be consistent with the work of international and regional organisations dealing with radio spectrum management, such as the International Telecommunications Union (ITU) and the European Conference of Postal and Telecommunications Administrations (CEPT), in order to ensure the effective management of and harmonisation of the use of radio spectrum across the Union and between the Member States and other members of the ITU. (34) In accordance with the principle of the separation of regulatory and operational functions, Member States should guarantee the independence of the national regulatory and other competent authorities with a view to ensuring the impartiality of their decisions. This requirement of independence is without prejudice to the institutional autonomy and constitutional obligations of the Member States or to the principle of neutrality with regard to the rules in Member States governing the system of property ownership laid down in Article 345 TFEU. National regulatory and other competent authorities should be in possession of all the necessary resources, in terms of staffing, expertise, and financial means, for the performance of their tasks. (35) Certain tasks pursuant to the Directive, such as ex ante market regulation, including the imposition of obligations for access and interconnection, and the resolution of disputes between undertakings are tasks which should be undertaken only by national regulatory authorities, namely, bodies which are independent both from the sector and from any external intervention or political pressure. Unless otherwise provided, Member States should be able to assign other regulatory tasks provided for in this Directive either to the national regulatory authorities or to other competent authorities. In the course of transposition, Member States should promote the stability of competences of the national regulatory authorities with regard to the assignment of tasks which resulted from the transposition of the Union electronic communications regulatory framework as amended in 2009, in particular those related to market competition or market entry. Where tasks are assigned to other competent authorities, those other competent authorities should seek to consult the national regulatory authorities before taking a decision. Pursuant to the principle of good cooperation, national regulatory and other competent authorities should exchange information for the exercise of their tasks. (36) This Directive does not include substantive provisions on open internet access or roaming and is without prejudice to the allocation of competences to national regulatory authorities in Regulation (EU) No 531/2012 of the European Parliament and of the Council (20) and in Regulation (EU) 2015/2120. However, this Directive provides, in addition, for national regulatory authorities to be competent for assessing and monitoring closely market access and competition issues which potentially affect the rights of end-users to an open internet access. (37) The independence of the national regulatory authorities was strengthened in the review of the electronic communications regulatory framework completed in 2009 in order to ensure a more effective application of the regulatory framework and to increase their authority and the predictability of their decisions. To that end, express provision had to be made in national law to ensure that, in the exercise of its tasks, a national regulatory authority is protected against external intervention or political pressure liable to jeopardise its independent assessment of matters coming before it. Such outside influence makes a national legislative body unsuited to act as a national regulatory authority under the regulatory framework. For that purpose, rules had to be laid down at the outset regarding the grounds for the dismissal of the head of the national regulatory authority in order to remove any reasonable doubt as to the neutrality of that body and its imperviousness to external factors. In order to avoid arbitrary dismissals, dismissed members should have the right to request that the competent courts verify the existence of a valid reason to dismiss, among those provided for in this Directive. Such dismissals should relate only to the personal or professional qualifications of the head or member. It is important that national regulatory authorities have their own budget allowing them, in particular, to recruit a sufficient number of qualified staff. In order to ensure transparency, that budget should be published annually. Within the limits of their budget, they should have autonomy in managing their resources, human and financial. In order to ensure impartiality, Member States that retain ownership of, or control, undertakings contributing to the budget of the national regulatory or other competent authorities through administrative charges should ensure that there is effective structural separation of activities associated with the exercise of ownership or control from the exercise of control over the budget. (38) There is a need to further reinforce the independence of the national regulatory authorities to ensure the imperviousness of its head and members to external pressure, by providing minimum appointment qualifications, and a minimum duration for their mandate. Furthermore, to address the risk of regulatory capture, ensure continuity and enhance independence, Member States should consider limiting the possibility of renewing the mandates of the head or members of the board and set up an appropriate rotation scheme for the board and the top management. This could be arranged, for instance, by appointing the first members of the collegiate body for different periods in order for their mandates, as well as that of their successors, not to lapse at the same moment. (39) National regulatory authorities should be accountable for, and should be required to report on, the way in which they are exercising their tasks. That obligation should normally take the form of an annual reporting obligation rather than ad hoc reporting requests, which, if disproportionate, could limit their independence or hinder them in the exercise of their tasks. Indeed, according to the case-law of the Court of Justice (21), extensive or unconditional reporting obligations may indirectly affect the independence of an authority. (40) Member States should notify the Commission of the identity of the national regulatory and other competent authorities. For authorities competent for granting rights of way, it should be possible to fulfil the notification requirement by a reference to the single information point established pursuant to Directive 2014/61/EU of the European Parliament and of the Council (22). (41) The least onerous authorisation system possible should be used to allow the provision of electronic communications networks and services in order to stimulate the development of new communications services and pan-European communications networks and services and to allow service providers and consumers to benefit from the economies of scale of the internal market. (42) The benefits of the internal market to service providers and end-users can be best achieved by general authorisation of electronic communications networks and of electronic communications services other than number-independent interpersonal communications services, without requiring any explicit decision or administrative act by the national regulatory authority and by limiting any procedural requirements to a declaratory notification only. Where Member States require notification by providers of electronic communications networks or services when they start their activities, such notification should not entail administrative cost for the providers and could be made available via an entry point at the website of the competent authorities. In order to support effective cross-border coordination, in particular for pan-European operators, BEREC should establish and maintain a database of such notifications. Competent authorities should transmit only complete notifications to BEREC. Member States should not impede the provision of networks or services in any way, including on grounds of incompleteness of a notification. (43) Notifications should entail a mere declaration of the provider’s intention to commence the provision of electronic communications networks and services. A provider should be required to complement that declaration only with the information set out in this Directive. Member States should not impose additional or separate notification requirements. (44) Contrary to the other categories of electronic communications networks and services as defined in this Directive, number-independent interpersonal communications services do not benefit from the use of public numbering resources and do not participate in a publicly assured interoperable ecosystem. It is therefore not appropriate to subject those types of services to the general authorisation regime. (45) When granting rights of use for radio spectrum, for numbering resources or rights to install facilities, the competent authorities should inform the undertakings to which they grant such rights of the relevant conditions. Member States should be able to lay down such conditions for the use of radio spectrum in individual rights of use or in the general authorisation. (46) General authorisations should contain only conditions which are specific to the electronic communications sector. They should not be made subject to conditions which are already applicable by virtue of other existing national law, in particular regarding consumer protection, which is not specific to the communications sector. For instance, competent authorities should be able to inform undertakings about the applicable environmental and town-and-country-planning requirements. Conditions imposed under the general authorisation do not affect the determination of applicable law pursuant to Regulation (EC) No 593/2008 of the European Parliament and of the Council (23). (47) The conditions that could be attached to general authorisations should cover specific conditions governing accessibility for end-users with disabilities and the need of public authorities and emergency services to communicate between themselves and with the general public before, during and after major disasters. (48) It is necessary to include the rights and obligations of undertakings under general authorisations explicitly in such authorisations in order to ensure a level playing field throughout the Union and to facilitate cross-border negotiation of interconnection between public electronic communications networks. (49) General authorisations entitle undertakings providing electronic communications networks and services to the public to negotiate interconnection under the conditions of this Directive. Undertakings providing electronic communications networks and services other than to the public can negotiate interconnection on commercial terms. (50) Competent authorities should duly take into account, when attaching conditions to general authorisations and applying administrative charges, situations in which electronic communications networks or services are provided by natural persons on a not-for-profit basis. In the case of electronic communications networks and services not provided to the public it is appropriate to impose fewer and lighter conditions, if any, than are justified for electronic communications networks and services provided to the public. (51) Specific obligations imposed on undertakings providing electronic communications networks and electronic communications services in accordance with Union law by virtue of their designation as having significant market power as defined in this Directive should be imposed separately from the general rights and obligations under the general authorisation. (52) It is possible that undertakings providing electronic communications networks and services need confirmation of their rights under the general authorisation with respect to interconnection and rights of way, in particular to facilitate negotiations with other, regional or local, levels of government or with service providers in other Member States. To that end competent authorities should provide declarations to undertakings either upon request or alternatively as an automatic response to a notification under the general authorisation. Such declarations should not by themselves constitute entitlements to rights, nor should any rights under the general authorisation, rights of use or the exercise of such rights depend upon a declaration. (53) It should be possible to impose administrative charges on undertakings providing electronic communications services in order to finance the activities of the national regulatory or other competent authority in managing the general authorisation system and the granting of rights of use. Such charges should be limited to cover the actual administrative costs for those activities. To that end, transparency should be ensured in the income and expenditure of national regulatory and other competent authorities by means of annual reporting about the total sum of charges collected and the administrative costs incurred, in order to allow undertakings to verify that they are in balance. (54) Systems for administrative charges should not distort competition or create barriers to market entry. A general authorisation system renders it impossible to attribute administrative costs and hence charges to individual undertakings, except for the granting of rights of use for numbering resources, radio spectrum and for rights to install facilities. Any applicable administrative charges should be in line with the principles of a general authorisation system. An example of a fair, simple and transparent alternative for those charge attribution criteria could be a turnover related distribution key. Where administrative charges are very low, flat rate charges, or charges combining a flat rate basis with a turnover related element could also be appropriate. To the extent that the general authorisation system extends to undertakings with very small market shares, such as community-based network providers, or to service providers the business model of which generates very limited revenues even in the case of significant market penetration in terms of volumes, Member States should assess the possibility to establish an appropriate de minimis threshold for the imposition of administrative charges. (55) Member States might need to amend rights, conditions, procedures, charges and fees relating to general authorisations and rights of use where this is objectively justified. Such proposed amendments should be duly notified to all interested parties in good time, giving them adequate opportunity to express their views. Unnecessary procedures should be avoided in the case of minor amendments to existing rights to install facilities or rights of use for radio spectrum or for numbering resources when such amendments do not have an impact on third parties’ interests. Minor amendments to rights and obligations are amendments which are mainly administrative, do not change the substantial nature of the general authorisations and the individual rights of use and thus cannot generate any competitive advantage over other undertakings. (56) Considering the importance of ensuring legal certainty and in order to promote regulatory predictability to provide a safe environment for investments, in particular for new wireless broadband communications, any restriction or withdrawal of any existing rights of use for radio spectrum or for numbering resources or right to install facilities should be subject to predictable and transparent justifications and procedures. Hence, stricter requirements or a notification mechanism could be imposed in particular where rights of use have been assigned pursuant to competitive or comparative procedures and in the case of harmonised radio spectrum bands to be used for wireless broadband electronic communications services (‘wireless broadband services’). Justifications referring to effective and efficient use of radio spectrum and technological evolution could rely on technical implementing measures adopted under Decision No 676/2002/EC of the European Parliament and of the Council (24). Furthermore, except where proposed amendments are minor, where general authorisations and individual rights of use for radio spectrum need to be restricted, withdrawn or amended without the consent of the holder of the right, this can take place after consulting interested parties. As restrictions or withdrawals of general authorisations or rights may have significant consequences for their holders, the competent authorities should take particular care and assess in advance the potential harm that such measures may cause before adopting such measures. (57) National regulatory authorities, other competent authorities and BEREC need to gather information from market players in order to carry out their tasks effectively, including assessing the compliance of general terms and conditions with this Directive without suspending the applicability of those terms and conditions during the assessment. It may, by way of exception, also be necessary to gather information from other undertakings active in sectors that are closely related to the electronic communications services sector, such as content providers, that hold information which could be necessary for them to exercise their tasks under Union law. It might also be necessary to gather such information on behalf of the Commission, to allow it to fulfil its respective obligations under Union law. Requests for information should be proportionate and not impose an undue burden on undertakings. Information gathered by national regulatory and other competent authorities should be publicly available, except in so far as it is confidential in accordance with national rules on public access to information and subject to Union and national rules on commercial confidentiality. (58) In order to ensure that national regulatory authorities carry out their regulatory tasks in an effective manner, the data which they gather should include accounting data on the retail markets that are associated with wholesale markets where an undertaking is designated as having significant market power and as such are regulated by the national regulatory authority. The data should also include data which enable the national regulatory authority to assess compliance with conditions attached to rights of use, the possible impact of planned upgrades or changes to network topology on the development of competition or on wholesale products made available to other parties. Information regarding compliance with coverage obligations attached to rights of use for radio spectrum is key to ensure completeness of the geographical surveys of network deployments. In that respect, the competent authority should be able to require that information is provided at disaggregated local level with a granularity adequate to conduct a geographical survey of networks. (59) To alleviate the burden of reporting and information obligations for network and service providers and the competent authority concerned, such obligations should be proportionate, objectively justified and limited to what is strictly necessary. In particular, duplication of requests for information by the competent authority and by BEREC, and the systematic and regular proof of compliance with all conditions under a general authorisation or a right of use, should be avoided. Undertakings should be aware of the intended use of the information sought. Provision of information should not be a condition for market access. For statistical purposes, a notification may be required from providers of electronic communications networks or services when they cease activities. (60) Member States’ obligations to provide information for the defence of Union interests under international agreements as well as reporting obligations under law that is not specific to the electronic communications sector such as competition law should not be affected. (61) It should be possible to exchange information that is considered to be confidential by a competent authority, in accordance with Union and national rules on commercial confidentiality and on the protection of personal data, with the Commission, BEREC and any other authorities where such exchange is necessary for the application of national law transposing this Directive. The information exchanged should be limited to that which is relevant and proportionate to the purpose of such an exchange. (62) Electronic communications broadband networks are becoming increasingly diverse in terms of technology, topology, medium used and ownership. Therefore, regulatory intervention must rely on detailed information regarding network roll-out in order to be effective and to target the areas where it is needed. That information is essential for the purpose of promoting investment, increasing connectivity across the Union and providing information to all relevant authorities and citizens. It should include surveys regarding both deployment of very high capacity networks, as well as significant upgrades or extensions of existing copper or other networks which might not match the performance characteristics of very high capacity networks in all respects, such as roll-out of fibre to the cabinet coupled with active technologies like vectoring. The relevant forecasts should concern periods of up to three years. The level of detail and territorial granularity of the information that competent authorities should gather should be guided by the specific regulatory objective, and should be adequate for the regulatory purposes that it serves. Therefore, the size of the territorial unit will also vary between Member States, depending on the regulatory needs in the specific national circumstances, and on the availability of local data. Level 3 in the Nomenclature of Territorial Units for Statistics (NUTS) is unlikely to be a sufficiently small territorial unit in most circumstances. National regulatory and other competent authorities should be guided by BEREC guidelines on best practice to approach such a task, and such guidelines will be able to rely on the existing experience of national regulatory and/or other competent authorities in conducting geographical surveys of networks roll-out. Without prejudice to commercial confidentiality requirements, competent authorities should, where the information is not already available on the market, make data directly accessible in an open format in accordance with Directive 2003/98/EC of the European Parliament and of the Council (25) and without restrictions on reuse the information gathered in such surveys and should make available tools to end-users as regards quality of service to contribute towards the improvement of their awareness of the available connectivity services. In gathering any of that information, all authorities concerned should respect the principle of confidentiality, and should avoid causing a competitive disadvantage to any undertaking. (63) Bridging the digital divide in the Union is essential to enable all citizens of the Union to have access to the internet and digital services. To that end, in the case of specific and well-defined areas, the relevant authorities should have the possibility to invite undertakings and public authorities to declare their intention to deploy very high capacity networks in these areas, allowing them sufficient time to provide a thoroughly considered response. The information included in the forecasts should reflect the economic prospects of the electronic communications networks sector and investment intentions of undertakings at the time when the data are gathered, in order to allow the identification of available connectivity in different areas. Where an undertaking or public authority declares an intention to deploy in an area, the national regulatory or other competent authority should be able to require other undertakings and public authorities to declare whether or not they intend to deploy very high capacity networks, or significantly upgrade or extend their network to a performance of at least 100 Mbps download speeds in this area. That procedure will create transparency for undertakings and public authorities that have expressed their interest in deploying in this area, so that, when designing their business plans, they can assess the likely competition that they will face from other networks. The positive effect of such transparency relies on market participants responding truthfully and in good faith. (64) While market participants can change their deployment plans for unforeseen, objective and justifiable reasons, competent authorities should intervene, including if public funding is affected, and, where appropriate, impose penalties if they have been provided, knowingly or due to gross negligence, by an undertaking or public authority with misleading erroneous or incomplete information. For the purpose of the relevant provisions on penalties, gross negligence should refer to a situation where an undertaking or a public authority provides misleading, erroneous or incomplete information due to its behaviour or internal organisation which falls significantly below due diligence regarding the information provided. Gross negligence should not require that the undertaking or public authority knows that the information provided is misleading, erroneous or incomplete, but, rather, that it would have known, had it acted or been organised with due diligence. It is important that the penalties are sufficiently dissuasive in light of the negative impact on competition and on publicly funded projects. The provisions on penalties should be without prejudice to any rights to claim compensation for damages in accordance with national law. (65) In the interests of predictable investment conditions, competent authorities should be able to share information with undertakings and public authorities expressing interest in deploying very high capacity networks on whether other types of network upgrades, including those below 100 Mbps download speed, are present or foreseen in the area in question. (66) It is important that national regulatory and other competent authorities consult all interested parties on proposed decisions, give them sufficient time to the complexity of the matter to provide their comments, and take account of their comments before adopting a final decision. In order to ensure that decisions at national level do not have an adverse effect on the functioning of the internal market or other TFEU objectives, national regulatory authorities should also notify certain draft decisions to the Commission and other national regulatory authorities to give them the opportunity to comment. It is appropriate for competent authorities to consult interested parties in the cases defined in this Directive on all draft measures which have an effect on trade between Member States. (67) In the context of a competitive environment, the views of interested parties, including users and consumers, should be taken into account. In order to appropriately address the interests of citizens, Member States should put in place an appropriate consultation mechanism. Such a mechanism could take the form of a body which would, independently of the national regulatory authority and service providers, carry out research into consumer-related issues, such as consumer behaviour and mechanisms for changing suppliers, and which would operate in a transparent manner and contribute to the existing mechanisms for stakeholder consultation. Furthermore, a mechanism could be established for the purpose of enabling appropriate cooperation on issues relating to the promotion of lawful content. Any cooperation procedures agreed pursuant to such a mechanism should, however, not allow for the systematic surveillance of internet use. (68) Out-of-court dispute resolution procedures may constitute a fast and cost-efficient way for end-users to enforce their rights, in particular for consumers and microenterprises and small enterprises as defined in the Annex to Commission Recommendation 2003/361/EC (26). Member States should enable the national regulatory authority or another competent authority responsible for, or at least one independent body with proven expertise in dealing with, end-user rights to act as an alternative dispute resolution entity. With respect to such dispute resolutions, those authorities should not be subject to any instructions. As many Member States have established dispute resolution procedures also for end-users other than consumers, to whom Directive 2013/11/EU of the European Parliament and of the Council (27) does not apply, it is reasonable to maintain the sector-specific dispute resolution procedure for both consumers and, where Member States extend it, also for other end-users, in particular microenterprises and small enterprises. In relation to out-of-court dispute resolution, Member States should be able to maintain or introduce rules that go beyond those laid down by Directive 2013/11/EU in order to ensure a higher level of consumer protection. (69) In the event of a dispute between undertakings in the same Member State in an area covered by this Directive, for example relating to obligations for access and interconnection or to the means of transferring end-user lists, an aggrieved party that has negotiated in good faith but failed to reach agreement should be able to call on the national regulatory authority to resolve the dispute. National regulatory authorities should be able to impose a solution on the parties. The intervention of a national regulatory authority in the resolution of a dispute between providers of electronic communications networks or services or associated facilities in a Member State should seek to ensure compliance with the obligations arising under this Directive. (70) In addition to the rights of recourse granted under Union or national law, there is a need for a simple procedure to be initiated at the request of either party in a dispute, to resolve cross-border disputes between undertakings providing, or authorised to provide, electronic communications networks or services in different Member States. (71) One important task assigned to BEREC is to adopt, where appropriate, opinions in relation to cross-border disputes. National regulatory authorities should therefore fully reflect any opinion submitted by BEREC in their measures imposing any obligation on an undertaking or otherwise resolving the dispute in such cases. (72) Lack of coordination between Member States when organising the use of radio spectrum in their territory can, if not solved through bilateral Member States negotiations, create large-scale interference issues severely impacting on the development of the Digital Single Market. Member States should take all necessary measures to avoid cross-border and harmful interference between them. The Radio Spectrum Policy Group (RSPG) established by Commission Decision 2002/622/EC (28) should be tasked with supporting the necessary cross-border coordination and be the designated forum for resolving disputes between Member States on cross border issues. Building on the RSPG’s proposed solution, an implementing measure is required in some circumstances to resolve cross-border interference definitively or to enforce under Union law a coordinated solution agreed by two or several Member States in bilateral negotiations. Lack of coordination between Member States and countries neighbouring the Union can also create large-scale interference issues. Member States should take appropriate measures to avoid cross-border and harmful interference with countries neighbouring the Union, and cooperate with each other to that end. Upon the request of Member States affected by cross-border interference from third countries, the Union should provide its full support for those Member States. (73) The RSPG is a Commission high-level advisory group which was created by Decision 2002/622/EC to contribute to the development of the internal market and to support the development of a Union-level radio spectrum policy, taking into account economic, political, cultural, strategic, health and social considerations, as well as technical parameters. It should be composed of the heads of the bodies that have overall political responsibility for strategic radio spectrum policy. It should assist and advise the Commission with respect to radio spectrum policy. This should further increase the visibility of radio spectrum policy in the various Union policy areas and help to ensure cross-sectorial consistency at Union and national and level. It should also provide advice to the European Parliament and to the Council upon their request. Moreover, the RSPG should also be the forum for the coordination of implementation by Member States of their obligations related to radio spectrum under this Directive and should play a central role in fields essential for the internal market such as cross-border coordination or standardisation. Technical or expert working groups could also be created to assist plenary meetings, at which strategic policy is framed through senior-level representatives of the Member States and the Commission. The Commission has indicated its intention to amend Decision 2002/622/EC within six months of the entry into force of this Directive, in order to reflect the new tasks conferred on the RSPG by this Directive. (74) Competent authorities should monitor and secure compliance with the terms and conditions of the general authorisation and rights of use, and in particular to ensure effective and efficient use of radio spectrum and compliance with coverage and quality of service obligations, through administrative penalties including financial penalties and injunctions and withdrawals of rights of use in the event of breaches of those terms and conditions. Undertakings should provide the most accurate and complete information possible to competent authorities to allow them to fulfil their surveillance tasks. (75) The conditions attached to general authorisations and individual rights of use should be limited to those strictly necessary to ensure compliance with requirements and obligations under national law and Union law. (76) Any party subject to a decision of a competent authority should have the right to appeal to a body that is independent of the parties involved and of any external intervention or political pressure which could jeopardise its independent assessment of matters coming before it. That body can be a court. Furthermore, any undertaking which considers that its applications for the granting of rights to install facilities have not been dealt with in accordance with the principles set out in this Directive should be entitled to appeal against such decisions. That appeal procedure should be without prejudice to the division of competences within national judicial systems and to the rights of legal entities or natural persons under national law. In any case, Member States should grant effective judicial review against such decisions. (77) In order to ensure legal certainty for market players, appeal bodies should carry out their functions effectively. In particular, appeal proceedings should not be unduly lengthy. Interim measures suspending the effect of the decision of a competent authority should be granted only in urgent cases in order to prevent serious and irreparable damage to the party applying for those measures and if the balance of interests so requires. (78) There has been a wide divergence in the manner in which appeal bodies have applied interim measures to suspend the decisions of the national regulatory or other competent authorities. In order to achieve greater consistency of approach common standards should be applied in line with the case law of the Court of Justice. Appeal bodies should also be entitled to request available information published by BEREC. Given the importance of appeals for the overall operation of the regulatory framework, a mechanism should be set up, in all the Member States, for collecting information on appeals and decisions to suspend decisions taken by the competent authorities and for the reporting of that information to the Commission and to BEREC. That mechanism should ensure that the Commission or BEREC can retrieve from Member States the text of the decisions and judgments with a view to developing a database. (79) Transparency in the application of the Union mechanism for consolidating the internal market for electronic communications should be increased in the interest of citizens and stakeholders and to enable parties concerned to make their views known, including by way of requiring national regulatory authorities to publish any draft measure at the same time as it is communicated to the Commission, to BEREC, and to the national regulatory authorities in other Member States. Any such draft measure should be reasoned and should contain a detailed analysis. (80) The Commission should be able, after taking utmost account of the opinion of BEREC, to require a national regulatory authority to withdraw a draft measure where it concerns the definition of relevant markets or the designation of undertakings as having significant market power, and where such decisions would create a barrier to the internal market or would be incompatible with Union law and in particular the policy objectives that national regulatory authorities should follow. This procedure is without prejudice to the notification procedure provided for in Directive (EU) 2015/1535 and the Commission’s prerogatives under TFEU in respect of infringements of Union law. (81) The national consultation of interested parties should be conducted prior to the consultation at Union level for the purposes of consolidating the internal market for electronic communications and within the procedure for the consistent application of remedies, in order to allow the views of interested parties to be reflected in the consultation at Union level. This would also avoid the need for a second consultation at Union level in the event of changes to a planned measure as a result of the national consultation. (82) It is important that the regulatory framework is implemented in a timely manner. When the Commission has taken a decision requiring a national regulatory authority to withdraw a planned measure, national regulatory authorities should withdraw its draft measure or submit a revised measure to the Commission. A deadline should be laid down for the notification of the revised measure to the Commission in order to inform market players of the duration of the market review and in order to increase legal certainty. (83) The Union mechanism allowing the Commission to require national regulatory authorities to withdraw planned measures concerning market definition and the designation of undertakings as having significant market power has contributed significantly to a consistent approach in identifying the circumstances in which ex ante regulation may be applied and those in which the undertakings are subject to such regulation. The experience of the procedures under Articles 7 and 7a of Directive 2002/21/EC has shown that inconsistencies in the national regulatory authorities’ application of remedies under similar market conditions undermine the internal market in electronic communications. Therefore, the Commission and BEREC should participate in ensuring, within their respective responsibilities, a higher level of consistency in the application of remedies concerning draft measures proposed by national regulatory authorities. In addition, for draft measures relating to the extension of obligations beyond the first concentration or distribution point, where needed to address high and non-transitory economic or physical barriers to replication, on undertakings irrespective of a designation as having significant market power, or to the regulatory treatment of new very high-capacity network elements where BEREC shares the Commission’s concerns, the Commission should be able to require a national regulatory authority to withdraw a draft measure. In order to benefit from the expertise of national regulatory authorities on the market analysis, the Commission should consult BEREC prior to adoption of its decisions or recommendations. (84) Having regard to the short time-limits in the consultation mechanism at Union level, powers should be conferred on the Commission to adopt recommendations or guidelines to simplify the procedures for exchanging information between the Commission and national regulatory authorities, for example in cases concerning stable markets, or involving only minor changes to previously notified measures. Powers should also be conferred on the Commission in order to allow for the introduction of a notification exemption in order to streamline procedures in certain cases. (85) National regulatory authorities should be required to cooperate with each other, with BEREC and with the Commission, in a transparent manner, to ensure the consistent application, in all Member States, of this Directive. (86) The discretion of national regulatory authorities needs to be reconciled with the development of consistent regulatory practices and the consistent application of the regulatory framework in order to contribute effectively to the development and completion of the internal market. National regulatory authorities should therefore support the internal market activities of the Commission and of BEREC. (87) Measures that could affect trade between Member States are measures that could have an influence, direct or indirect, actual or potential, on the pattern of trade between Member States in a manner which might create a barrier to the internal market. They comprise measures that have a significant impact on undertakings or users in other Member States, which include: measures which affect prices for users in other Member States; measures which affect the ability of an undertaking established in another Member State to provide an electronic communications service, and in particular measures which affect the ability to offer services on a transnational basis; and measures which affect market structure or access, leading to repercussions for undertakings in other Member States. (88) A more convergent use and definition of elements of selection procedures and the conditions attached to the rights of use for radio spectrum which have a significant impact on market conditions and the competitive situation, including conditions for entry and expansion, would be enhanced by a coordination mechanism whereby the RSPG, at the request of the national regulatory or other competent authority or, exceptionally, on its own initiative, convenes a Peer Review Forum to examine draft measures in advance of the granting of rights of use by a given Member State with a view to exchanging best practices. The Peer Review Forum is an instrument of peer learning. It should contribute to a better exchange of best practices between Member States and increase the transparency of the competitive or comparative selection procedures. The Peer Review Process should not be a formal condition of national authorisation procedures. The exchange of views should be based on information provided by the national regulatory or other competent authority that requests the Peer Review Forum and should be a subset of a wider national measure, which may more broadly consist of the granting, trade and lease, duration, renewal or the amendment of rights of use. Therefore, the national regulatory or other competent authority should also be able to provide information on other draft national measures or aspects thereof related to the relevant selection procedure for limiting rights of use for radio spectrum which are not covered by the peer review mechanism. To reduce administrative burden, the national regulatory or other competent authority should be able to submit such information by way of a common reporting format, where available, for transmission to the RSPG members. (89) Where the harmonised assignment of radio spectrum to particular undertakings has been agreed at Union level, Member States should strictly implement such agreements in the granting of rights of use for radio spectrum from the National Frequency Allocation Plan. (90) Member States should be able to consider joint authorisation processes as an option when issuing rights of use where the expected usage covers cross-border situations. (91) Any Commission decision to ensure the harmonised application of this Directive should be limited to regulatory principles, approaches and methodologies. For the avoidance of doubt, it should not prescribe any detail normally required to reflect national circumstances, and it should not prohibit alternative approaches which can reasonably be expected to have equivalent effect. Such a decision should be proportionate and should not have an effect on decisions taken by national regulatory or other competent authorities that do not create a barrier to the internal market. (92) The Union and the Member States have entered into commitments in relation to standards and the regulatory framework of telecommunications networks and services in the World Trade Organization. (93) Standardisation should remain primarily a market-driven process. However there may still be situations where it is appropriate to require compliance with specified standards at Union level in order to improve interoperability, freedom of choice for users and encourage interconnectivity in the internal market. At national level, Member States are subject to Directive (EU) 2015/1535. Standardisation procedures under this Directive are without prejudice to Directives 2014/30/EU (29) and 2014/35/EU (30) of the European Parliament and of the Council, and Directive 2014/53/EU. (94) Providers of public electronic communications networks or publicly available electronic communications services, or of both, should be required to take measures to safeguard the security of their networks and services, respectively, and to prevent or minimise the impact of security incidents. Having regard to the state of the art, those measures should ensure a level of security of networks and services appropriate to the risks posed. Security measures should take into account, as a minimum, all the relevant aspects of the following elements: as regards security of networks and facilities: physical and environmental security, security of supply, access control to networks and integrity of networks; as regards handling of security incidents: handling procedures, security incident detection capability, security incident reporting and communication; as regards business continuity management: service continuity strategy and contingency plans, disaster recovery capabilities; as regards monitoring, auditing and testing: monitoring and logging policies, exercise contingency plans, network and service testing, security assessments and compliance monitoring; and compliance with international standards. (95) Given the growing importance of number-independent interpersonal communications services, it is necessary to ensure that they are also subject to appropriate security requirements in accordance with their specific nature and economic importance. Providers of such services should thus also ensure a level of security appropriate to the risk posed. Given that providers of number-independent interpersonal communications services normally do not exercise actual control over the transmission of signals over networks, the degree of risk for such services can be considered in some respects to be lower than for traditional electronic communications services. Therefore, where justified on the basis of the actual assessment of the security risks involved, the measures taken by providers of number-independent interpersonal communications services should be lighter. The same approach should apply mutatis mutandis to interpersonal communications services which make use of numbers and which do not exercise actual control over signal transmission. (96) Providers of public electronic communications networks or of publicly available electronic communications services should inform users of particular and significant security threats and of measures they can take to protect the security of their communications, for instance by using specific types of software or encryption technologies. The requirement to inform users of such threats should not discharge a service provider from the obligation to take, at its own expense, appropriate and immediate measures to remedy any security threats and restore the normal security level of the service. The provision of such information about security threats to the user should be free of charge. (97) In order to safeguard security of networks and services, and without prejudice to the Member States’ powers to ensure the protection of their essential security interests and public security, and to permit the investigation, detection and prosecution of criminal offences, the use of encryption for example, end-to-end where appropriate, should be promoted and, where necessary, encryption should be mandatory in accordance with the principles of security and privacy by default and by design. (98) Competent authorities should ensure that the integrity and availability of public electronic communications networks are maintained. The European Union Agency for Network and Information Security (‘ENISA’) should contribute to an enhanced level of security of electronic communications by, inter alia, providing expertise and advice, and promoting the exchange of best practices. The competent authorities should have the necessary means to perform their duties, including powers to request the information necessary to assess the level of security of networks or services. They should also have the power to request comprehensive and reliable data about actual security incidents that have had a significant impact on the operation of networks or services. They should, where necessary, be assisted by Computer Security Incident Response Teams (‘CSIRTs’) established by Directive (EU) 2016/1148 of the European Parliament and of the Council (31). In particular, CSIRTs may be required to provide competent authorities with information about risks and security incidents affecting public electronic communications networks and publicly available electronic communications services, and recommend ways to address them. (99) Where the provision of electronic communications relies on public resources the use of which is subject to specific authorisation, Member States should be able to grant the authority competent for issuance thereof the right to impose fees to ensure optimal use of those resources, in accordance with the procedures envisaged in this Directive. In line with the case-law of the Court of Justice, Member States cannot levy any charges or fees in relation to the provision of networks and electronic communications services other than those provided for by this Directive. In that regard, Member States should have a consistent approach in establishing those charges or fees in order not to provide an undue financial burden linked to the general authorisation procedure or rights of use for providers of electronic communications networks and services. (100) To ensure optimal use of resources, fees should reflect the economic and technical situation of the market concerned as well as any other significant factor determining their value. At the same time, fees should be set in a manner that ensures efficient assignment and use of radio spectrum. This Directive is without prejudice to the purpose for which fees for rights of use and rights to install facilities are employed. It should be possible, for example, to use such fees to finance activities of national regulatory and other competent authorities that cannot be covered by administrative charges. Where, in the case of competitive or comparative selection procedures, fees for rights of use for radio spectrum consist entirely or partly of a one-off amount, payment arrangements should ensure that such fees do not in practice lead to selection on the basis of criteria unrelated to the objective of ensuring optimal use of radio spectrum. The Commission should be able to publish, on a regular basis, benchmark studies and, as appropriate, other guidance with regard to best practices for the assignment of radio spectrum, the assignment of numbering resources or the granting of rights of way. (101) Fees imposed on undertakings for rights of use for radio spectrum can influence decisions about whether to seek such rights and put into use radio spectrum resources. With a view to ensuring optimal use of radio spectrum, Member States should therefore set reserve prices in a way that leads to the efficient assignment of those rights, irrespective of the type of selection procedure used. Member States could also take into account possible costs associated with the fulfilment of authorisation conditions imposed to further policy objectives. In doing so, regard should also be had to the competitive situation of the market concerned including the possible alternative uses of the resources. (102) Optimal use of radio spectrum resources depends on the availability of appropriate networks and associated facilities. In that regard, Member States should aim to ensure that, where national regulatory or other competent authorities apply fees for rights of use for radio spectrum and for rights to install facilities, they take into consideration the need to facilitate continuous infrastructure development with a view to achieving the most efficient use of the resources. Member States should seek to ensure the application, to the best extent possible, of arrangements for the payment of the fees for rights of use for radio spectrum linked with the actual availability of the resource in a manner that supports the investments necessary to promote such infrastructure development and the provision of related services. The payment arrangements should be specified in an objective, transparent, proportionate and non-discriminatory manner before opening procedures for the granting of rights of use for radio spectrum. (103) It should be ensured that procedures exist for the granting of rights to install facilities that are timely, non-discriminatory and transparent, in order to guarantee the conditions for fair and effective competition. This Directive is without prejudice to national provisions governing the expropriation or use of property, the normal exercise of property rights, the normal use of the public domain, or to the principle of neutrality with regard to the rules in Member States governing the system of property ownership. (104) Permits issued to providers of electronic communications networks and services allowing them to gain access to public or private property are essential factors for the establishment of electronic communications networks or new network elements. Unnecessary complexity and delay in the procedures for granting rights of way may therefore represent important obstacles to the development of competition. Consequently, the acquisition of rights of way by authorised undertakings should be simplified. Competent authorities should coordinate the acquisition of rights of way, making relevant information accessible on their websites. (105) It is necessary to strengthen the powers of the Member States as regards holders of rights of way to ensure the entry or roll-out of a new network in a fair, efficient and environmentally responsible way and independently of any obligation on an undertaking designated as having significant market power to grant access to its electronic communications network. Improving facility sharing can lower the environmental cost of deploying electronic communications infrastructure and serve public health, public security and meet town and country planning objectives. Competent authorities should be empowered to require that the undertakings which have benefitted from rights to install facilities on, over or under public or private property share such facilities or property, including physical co-location, after an appropriate period of public consultation, during which all interested parties should be given the opportunity to state their views, in the specific areas where such general interest reasons impose such sharing. That can be the case for instance where the subsoil is highly congested or where a natural barrier needs to be crossed. Competent authorities should in particular be able to impose the sharing of network elements and associated facilities, such as ducts, conduits, masts, manholes, cabinets, antennae, towers and other supporting constructions, buildings or entries into buildings, and a better coordination of civil works on environmental or other public policy grounds. On the contrary, it should be for national regulatory authorities to define rules for apportioning the costs of the facility or property sharing, to ensure that there is an appropriate reward of risk for the undertakings concerned. In light of the obligations imposed by Directive 2014/61/EU, the competent authorities, in particular, local authorities, should also establish appropriate coordination procedures, in cooperation with national regulatory authorities, with respect to public works and other appropriate public facilities or property which should be able to include procedures that ensure that interested parties have information concerning appropriate public facilities or property and ongoing and planned public works, that they are notified in a timely manner of such works, and that sharing is facilitated to the maximum extent possible. (106) Where mobile operators are required to share towers or masts for environmental reasons, such mandated sharing could lead to a reduction in the maximum transmitted power levels allowed for each operator for reasons of public health, and this in turn could require operators to install more transmission sites to ensure national coverage. Competent authorities should seek to reconcile the environmental and public health considerations in question, taking due account of the precautionary approach set out in Council Recommendation 1999/519/EC (32). (107) Radio spectrum is a scarce public resource with an important public and market value. It is an essential input for radio-based electronic communications networks and services and, insofar as it relates to such networks and services, should therefore be efficiently allocated and assigned by national regulatory or other competent authorities in accordance with harmonised objectives and principles governing their action as well as to objective, transparent and non-discriminatory criteria, taking into account the democratic, social, linguistic and cultural interests related to the use of radio spectrum. Decision No 676/2002/EC establishes a framework for harmonisation of radio spectrum. (108) Radio spectrum policy activities in the Union should be without prejudice to measures taken, at Union or national level, in accordance with Union law, to pursue general interest objectives, in particular with regard to public governmental and defence networks, content regulation and audiovisual and media policies, and the right of Member States to organise and use their radio spectrum for public order, public security and defence. (109) Ensuring widespread connectivity in each Member State is essential for economic and social development, participation in public life and social and territorial cohesion. As connectivity and the use of electronic communications become an integral element to European society and welfare, Member States should strive to ensure Union-wide wireless broadband coverage. Such coverage should be achieved by relying on the imposition by Member States of appropriate coverage requirements, which should be adapted to each area served and limited to proportionate burdens in order not to hinder deployment by service providers. Given the major role systems such as radio local area networks (RLANs) play in providing high-speed wireless broadband indoors, measures should aim to ensure the release of sufficient radio spectrum in bands which are particularly valuable assets for the cost-efficient deployment of wireless networks with universal coverage, in particular indoors. Moreover, consistent and coordinated measures for high-quality terrestrial wireless coverage across the Union, building on best national practices for operators’ licence obligations, should aim to meet the radio spectrum policy programme objective that all citizens of the Union should have access both indoors and outdoors, to the fastest broadband speeds of not less than 30 Mbps by 2020, and should aim to achieve an ambitious vision for a gigabit society in the Union. Such measures will promote innovative digital services and ensure long-term socioeconomic benefits. Seamless coverage of the territory as well as connectivity across Member States should be maximised and reliable, with a view to promoting in-border and cross-border services and applications such as connected cars and e-health. (110) The need to ensure that citizens are not exposed to electromagnetic fields at a level harmful to public health is imperative. Member States should pursue consistency across the Union to address this issue, having particular regard to the precautionary approach taken in Recommendation 1999/519/EC, in order to work towards ensuring more consistent deployment conditions. Member States should apply the procedure set out in Directive (EU) 2015/1535, where relevant, with a view also to providing transparency to stakeholders and to allow other Member States and the Commission to react. (111) Radio spectrum harmonisation and coordination, and equipment regulation supported by standardisation, are complementary and need to be coordinated closely to meet their joint objectives effectively, with the support of the RSPG. Coordination between the content and timing of mandates to CEPT under Decision No 676/2002/EC and standardisation requests to standardisation bodies, such as the European Telecommunications Standards Institute, including with regard to radio receivers parameters, should facilitate the introduction of future systems, support radio spectrum sharing opportunities and ensure efficient radio spectrum management. (112) The demand for harmonised radio spectrum is not uniform in all parts of the Union. Where there is lack of demand for all or part of a harmonised band at regional or national level, Member States could, by way of exception, allow an alternative use of the band, for example to cover lack of market supply for certain uses, for as long as such lack of demand persists and provided that the alternative use does not prejudice the harmonised use of the band by other Member States and that it ceases when demand for the harmonised use materialises. (113) Flexibility in radio spectrum management and access to radio spectrum has been established through technology and service-neutral authorisations to allow radio spectrum users to choose the best technologies and services to apply in radio spectrum bands declared available for electronic communications services in the relevant National Frequency Allocation Plans in accordance with Union law (‘the principle of technology neutrality and the principle of service neutrality’). The administrative determination of technologies and services should apply only when general interest objectives are at stake and should be clearly justified and subject to regular review. (114) Restrictions to the principle of technology neutrality should be appropriate and justified by the need to avoid harmful interference, for example by imposing emission masks and power levels, to ensure the protection of public health by limiting public exposure to electromagnetic fields, to ensure the proper functioning of services through an adequate level of technical quality of service, while not necessarily precluding the possibility of using more than one service in the same radio spectrum band, to ensure proper sharing of radio spectrum, in particular where its use is subject only to general authorisations, to safeguard efficient use of radio spectrum, or to fulfil a general interest objective in accordance with Union law. (115) Radio spectrum users should also be able to choose freely the services they wish to offer over the radio spectrum. On the other hand, measures should be allowed which require the provision of a specific service to meet clearly defined general interest objectives such as safety of life, the need to promote social, regional and territorial cohesion, or the avoidance of the inefficient use of radio spectrum to be permitted where necessary and proportionate. Those objectives should include the promotion of cultural and linguistic diversity and media pluralism, as defined by Member States in accordance with Union law. Except where necessary to protect safety of life or, by way of exception, to fulfil other general interest objectives as defined by Member States in accordance with Union law, exceptions should not result in certain services having exclusive use, but should rather grant them priority so that, insofar as possible, other services or technologies could coexist in the same radio spectrum band. It lies within the competence of the Member States to define the scope and nature of any exception regarding the promotion of cultural and linguistic diversity and media pluralism. (116) As the allocation of radio spectrum to specific technologies or services is an exception to the principles of technology and service neutrality and reduces the freedom to choose the service provided or technology used, any proposal for such allocation should be transparent and subject to public consultation. (117) Where Member States decide, by way of exception, to limit the freedom to provide electronic communications networks and services based on grounds of public policy, public security or public health, Member States should explain the reasons for such a limitation. (118) Radio spectrum should be managed in a manner that ensures the avoidance of harmful interference. The basic concept of harmful interference should therefore be properly defined to ensure that regulatory intervention is limited to the extent necessary to prevent such interference, having regard also to the need to take into consideration advanced methods for protection against harmful interference, with the aim of applying those technologies and radio spectrum management methods in order to avoid, to the extent possible, the application of the non-interference and non-protection principle. Transport has a strong cross-border element and its digitalisation brings challenges. Vehicles (such as metro, bus, cars, trucks, trains,) are becoming increasingly autonomous and connected. In the internal market, vehicles travel beyond national borders more easily. Reliable communications, and avoiding harmful interference, are critical for the safe and good operation of vehicles and their on-board communications systems. (119) With growing radio spectrum demand and new varying applications and technologies which necessitate more flexible access and use of radio spectrum, Member States should promote the shared use of radio spectrum by determining the most appropriate authorisation regimes for each scenario and by establishing appropriate and transparent rules and conditions therefor. Shared use of radio spectrum increasingly ensures its effective and efficient use by allowing several independent users or devices to access the same radio spectrum band under various types of legal regimes in order to make additional radio spectrum resources available, raise usage efficiency and facilitate radio spectrum access for new users. Shared use can be based on general authorisations or licence-exempt use allowing, under specific sharing conditions, several users to access and use the same radio spectrum in different geographic areas or at different moments in time. It can also be based on individual rights of use under arrangements such as licensed shared access where all users (with an existing user and new users) agree on the terms and conditions for shared access, under the supervision of the competent authorities, in such a way as to ensure a minimum guaranteed radio transmission quality. When allowing shared use under different authorisation regimes, Member States should not set widely diverging durations for such use under different authorisation regimes. (120) General authorisations for the use of radio spectrum may facilitate the most effective use of radio spectrum and foster innovation in some cases and are pro-competitive, whereas individual rights of use for radio spectrum in other cases may be the most appropriate authorisation regime in the presence of certain specific circumstances. Individual rights of use should be considered, for example, when favourable propagation characteristics of the radio spectrum or the envisaged power level of the transmission imply that general authorisations cannot address the interference concerns in light of the required quality of service. Technical measures such as solutions to improve receiver resilience might enable the use of general authorisations or radio spectrum sharing, and possibly avoid systematic recourse to the non-interference and non-protection principle. (121) In order to ensure predictability and preserve legal certainty and investment stability, Member States should establish, in advance, appropriate criteria to determine compliance with the objective of efficient use of radio spectrum by the holders of the rights when implementing the conditions attached to individual rights of use and general authorisations. Interested parties should be involved in the definition of such conditions and informed, in a transparent manner, about how the fulfilment of their obligations will be assessed. (122) In order to avoid the creation of barriers to market entry, namely through anti-competitive hoarding, enforcement of conditions attached to radio spectrum rights by Member States should be effective and all competent authorities should participate where necessary. Enforcement conditions should include the application of a ‘use it or lose it’ clause. In order to ensure legal certainty in respect of the possible exposure to any penalty for failure to use radio spectrum, thresholds of use, including in terms of time, quantity or identity of radio spectrum, should be established in advance. Trading and leasing of radio spectrum should ensure the effective use by the original holder of the right. (123) Where harmonised conditions for a radio spectrum band are established under Decision No 676/2002/EC, competent authorities are to decide on the most appropriate authorisation regime to be applied in that band or parts thereof. Where all Member States are likely to face similar problems for which diverging solutions could fragment the internal market in equipment, and thereby delay the rollout of 5G systems, it may be necessary for the Commission, taking utmost account of the opinion of the RSPG, to recommend common solutions, acknowledging technical harmonisation measures in force. This could provide a common toolbox for Member States which they could take into account when identifying appropriate consistent authorisation regimes to be applied to a band, or part of a band, depending on factors such as population density, propagation characteristics of the bands, divergence between urban and rural uses, the possible need to protect existing services and the resulting implications for economies of scale in manufacturing. (124) Network infrastructure sharing, and in some instances radio spectrum sharing, can allow for a more effective and efficient use of radio spectrum and ensure the rapid deployment of networks, especially in less densely populated areas. When establishing the conditions to be attached to rights of use for radio spectrum, competent authorities should also consider authorising forms of sharing or coordination between undertakings with a view to ensuring effective and efficient use of radio spectrum or compliance with coverage obligations, in accordance with competition law principles. (125) The requirement to respect the principles of technology and service neutrality in granting rights of use, together with the possibility to transfer rights between undertakings, underpin the freedom and means to deliver electronic communications services to the public, thereby also facilitating the achievement of general interest objectives. This Directive is without prejudice whether radio spectrum is assigned directly to providers of electronic communications networks or services or to entities that use those networks or services. Such entities may be radio or television broadcast content providers. The responsibility for compliance with the conditions attached to the right of use for radio spectrum and the relevant conditions attached to the general authorisation should in any case lie with the undertaking to which the right of use for radio spectrum has been granted. Certain obligations imposed on broadcasters for the delivery of audiovisual media services may require the use of specific criteria and procedures for the granting of radio spectrum usage rights to meet a specific general interest objective set out by Member States in accordance with Union law. However, the procedure for the granting of such right should in any event be objective, transparent, non-discriminatory and proportionate. (126) The case-law of the Court of Justice requires that any national restrictions to the rights guaranteed by Article 56 TFEU should be objectively justified and proportionate and should not exceed those necessary to achieve their objectives. Moreover, radio spectrum granted without following an open procedure should not be used for purposes other than the general interest objective for which they were granted. In such a case, the interested parties should be given the opportunity to comment within a reasonable period. As part of the application procedure for granting rights, Member States should verify whether the applicant is able to comply with the conditions to be attached to such rights. Those conditions should be reflected in eligibility criteria set out in objective, transparent, proportionate and non-discriminatory terms prior to the launch of any competitive selection procedure. For the purpose of applying such criteria, the applicant may be requested to submit the necessary information to prove his ability to comply with those conditions. Where such information is not provided, the application for the right of use for radio spectrum may be rejected. (127) Member States should, prior to the granting of the right, impose only the verification of elements that can reasonably be demonstrated by an applicant exercising ordinary care, taking due account of the important public and market value of radio spectrum as a scarce public resource. This is without prejudice to the possibility for subsequent verification of the fulfilment of eligibility criteria, for example through milestones, where criteria could not reasonably be met initially. To preserve effective and efficient use of radio spectrum, Member States should not grant rights where their review indicates applicants' inability to comply with the conditions, without prejudice to the possibility of facilitating time-limited experimental use. Sufficiently long duration of authorisations for the use of radio spectrum should increase investment predictability to contribute to faster network roll-out and better services, as well as stability to support radio spectrum trading and leasing. Unless use of radio spectrum is authorised for an unlimited period, such a duration should both take account of the objectives pursued and be sufficient to facilitate recoupment of the investments made. While a longer duration can ensure investment predictability, measures to ensure effective and efficient use of radio spectrum, such as the power of the competent authority to amend or withdraw the right in the case of non-compliance with the conditions attached to the rights of use, or the facilitation of radio spectrum tradability and leasing, will serve to prevent inappropriate accumulation of radio spectrum and support greater flexibility in distributing radio spectrum resources. Greater recourse to annualised fees is also a means to ensure a continuous assessment of the use of the radio spectrum by the holder of the right. (128) Considering the importance of technical innovation, Member States should be able to provide for rights to use radio spectrum for experimental purposes, subject to specific restrictions and conditions strictly justified by the experimental nature of such rights. (129) In deciding whether to renew already granted rights of use for harmonised radio spectrum, competent authorities should take into account the extent to which renewal would further the objectives of the regulatory framework and other objectives under Union and national law. Any such decision should be subject to an open, non-discriminatory and transparent procedure and based on a review of how the conditions attached to the rights concerned have been fulfilled. When assessing the need to renew rights of use, Member States should weigh the competitive impact of renewing assigned rights against the promotion of more efficient exploitation or of innovative new uses that might result if the band were opened to new users. Competent authorities should be able to make their determination in this regard by allowing for only a limited duration for renewal in order to prevent severe disruption of established use. While decisions on whether to renew rights assigned prior to the applicability of this Directive should respect any rules already applicable, Member States should also ensure that they do not prejudice the objectives of this Directive. (130) When renewing existing rights of use for harmonised radio spectrum, Member States should, together with the assessment of the need to renew the right, review the fees attached thereto with a view to ensuring that those fees continue to promote optimal use, taking account, inter alia, of market developments and technological evolution. For reasons of legal certainty, it is appropriate for any adjustments to the existing fees to be based on the same principles as those applicable to the award of new rights of use. (131) Effective management of radio spectrum can be ensured by facilitating the continued efficient use of radio spectrum that has already been assigned. In order to ensure legal certainty to holders of the rights, the possibility of renewal of rights of use should be considered within an appropriate time-span prior to the expiry of the rights concerned, for example, where rights have been assigned for 15 years or more, at least two years before expiry of those rights, unless the possibility of renewal was explicitly excluded at the time of assignment of the rights. In the interest of continuous resource management, competent authorities should be able to undertake such consideration at their own initiative as well as in response to a request from the assignee. The renewal of the right to use should not be granted contrary to the will of the assignee. (132) Transfer of rights of use for radio spectrum can be an effective means of increasing the efficient use of spectrum. For the sake of flexibility and efficiency, and to allow valuation of radio spectrum by the market, Member States should by default allow radio spectrum users to transfer or lease their rights of use for radio spectrum to third parties following a simple procedure and subject to the conditions attached to such rights and to competition rules, under the supervision of the national regulatory authorities responsible. In order to facilitate such transfers or leases, provided that technical implementing measures adopted under Decision No 676/2002/EC are respected, Member States should also consider requests to have radio spectrum rights partitioned or disaggregated and conditions for use reviewed. (133) Measures taken specifically to promote competition when granting or renewing rights of use for radio spectrum should be decided by national regulatory and other competent authorities, which have the necessary economic, technical and market knowledge. Radio spectrum assignment conditions can influence the competitive situation in electronic communications markets and conditions for entry. Limited access to radio spectrum, in particular when radio spectrum is scarce, can create a barrier to entry or hamper investment, network roll-out, the provision of new services or applications, innovation and competition. New rights of use, including those acquired through transfer or leasing, and the introduction of new flexible criteria for radio spectrum use can also influence existing competition. Where unduly applied, certain conditions used to promote competition, can have other effects; for example, radio spectrum caps and reservations can create artificial scarcity, wholesale access obligations can unduly constrain business models in the absence of market power, and limits on transfers can impede the development of secondary markets. Therefore, a consistent and objective competition test for the imposition of such conditions is necessary and should be applied consistently. The use of such measures should therefore be based on a thorough and objective assessment, by national regulatory and other competent authorities, of the market and the competitive conditions thereof. National competent authorities should, however, always ensure the effective and efficient use of radio spectrum and avoid distortion of competition through anti-competitive hoarding. (134) Building on opinions from the RSPG, the adoption of a common deadline for allowing the use of a radio spectrum band which has been harmonised under Decision No 676/2002/EC can be necessary to avoid cross-border interference and beneficial to ensure release of the full benefits of the related technical harmonisation measures for equipment markets and for the deployment of very high capacity networks and services. Allowing the use of a radio spectrum band entails assigning radio spectrum under a general authorisation regime or individual rights of use in order to permit the use of radio spectrum as soon as the assignment process is completed. In order to assign radio spectrum bands, it might be necessary to release a band occupied by other users and to compensate them. Implementation of a common deadline for allowing the use of harmonised bands for electronic communications services, including for 5G, might however be affected in a particular Member State by problems relating to unresolved cross-border coordination issues between Member States or with third countries, to the complexity of ensuring the technical migration of existing users of a band; a restriction to the use of the band based on a general interest objective, to the safeguarding of national security and defence or to force majeure. In any case, Member States should take all measures to reduce any delay to the minimum in terms of geographical coverage, timing and radio spectrum range. Moreover, Member States should be able, where appropriate in light of their assessment of the relevant circumstances, to request the Union to provide legal, political and technical support to resolve radio spectrum coordination issues with countries neighbouring the Union, including candidate and acceding countries, in such a way that the Member States concerned can observe their obligations under Union law. (135) In order to ensure increased coordinated availabilities of radio spectrum by 2020 to achieve very high speed fixed and wireless networks in the context of 5G, the 3,4-3,8 GHz and the 24,25-27,5 GHz bands have been identified by the RSPG as priority bands suitable to fulfil the objectives of the 5G Action Plan by 2020. The 40,5-43,5 GHz and 66-71 GHz bands have also been identified for further study. It is therefore necessary to ensure that, by 31 December 2020, the 3,4-3,8 GHz and the 24,25-27,5 GHz bands or parts thereof are available for terrestrial systems capable of providing wireless broadband services under harmonised conditions established by technical implementing measures adopted in accordance with Article 4 of Decision No 676/2002/EC, complementing Decision (EU) 2017/899 of the European Parliament and of the Council (33), as those bands have specific qualities, in terms of coverage and data capacity, which allow them to be combined appropriately to meet 5G requirements. Member States could, however, be affected by interference likely to arise from third countries which, in accordance with the ITU Radio Regulations, have identified those bands for services other than international mobile telecommunications. This might have an effect on the obligation to meet a common implementation date. Future use of the 26 GHz band for 5G terrestrial wireless services is likely, inter alia, to target urban areas and sub-urban hotspot areas, while some deployment can be foreseen along major roads and railway tracks in rural areas. This provides the opportunity to use the 26 GHz band for services other than 5G wireless outside those geographic areas, for example, for business specific communications or indoor use, and therefore allows Member States to designate and make that band available on a non-exclusive basis. (136) Where demand for a radio spectrum band exceeds the availability and, as a result, a Member State concludes that the rights of use for radio spectrum is to be limited, appropriate and transparent procedures should apply for the granting of such rights to avoid any discrimination and optimise the use of the scarce resource. Such limitation should be justified, proportionate and based on a thorough assessment of market conditions, giving due weight to the overall benefits for users and to national and internal market objectives. The objectives governing any limitation procedure should be clearly established in advance. When considering the most appropriate selection procedure, and in accordance with coordination measures taken at Union level, Member States should, in a timely and transparent manner, consult all interested parties on the justification, objectives and conditions of the procedure. Member States should be able to use, inter alia, competitive or comparative selection procedures for the assignment of radio spectrum or of numbering resources with exceptional economic value. In administering such schemes, competent authorities should take into account the objectives of this Directive. If a Member State finds that further rights can be made available in a band, it should start the process therefor. (137) Massive growth in radio spectrum demand, and in end-user demand for wireless broadband capacity, calls for solutions allowing alternative, complementary, spectrally efficient access solutions, including low-power wireless access systems with a small-area operating range, such as RLANs and networks of low-power small-size cellular access points. Such complementary wireless access systems, in particular publicly accessible RLAN access points, increase access to the internet for end-users and mobile traffic off-loading for mobile operators. RLANs use harmonised radio spectrum without requiring an individual authorisation or a right of use for radio spectrum. To date, most RLAN access points are used by private users as local wireless extension of their fixed broadband connection. End-users, within the limits of their own internet subscription, should not be prevented from sharing access to their RLAN with others, in order to increase the number of available access points, in particular, in densely populated areas, maximise wireless data capacity through radio spectrum re-use and create a cost-effective complementary wireless broadband infrastructure accessible to other end-users. Therefore, unnecessary restrictions to the deployment and interlinkage of RLAN access points should also be removed. (138) Public authorities or public service providers that use RLANs in their premises for their personnel, visitors or clients, for example to facilitate access to e-Government services or for information on public transport or road traffic management, could also provide access to such access points for general use by citizens as an ancillary service to services they offer to the public on such premises, to the extent allowed by competition and public procurement rules. Moreover, the provider of such local access to electronic communications networks within or around a private property or a limited public area on a non-commercial basis or as an ancillary service to another activity that is not dependent on such access, such as RLAN hotspots made available to customers of other commercial activities or to the general public in that area, can be subject to compliance with general authorisations for rights of use for radio spectrum but should not be subject to any conditions or requirements attached to general authorisations applicable to providers of public electronic communications networks or services or to obligations regarding end-users or interconnection. However, such a provider should remain subject to the liability rules set out in Directive 2000/31/EC of the European Parliament and of the Council (34). Further technologies, such as LiFi, are emerging and will complement current radio spectrum capabilities of RLANs and wireless access point to include optical visible light-based access points and lead to hybrid local area networks allowing optical wireless communication. (139) Since low power small-area wireless access points, such as femtocells, picocells, metrocells or microcells, can be very small and make use of unobtrusive equipment similar to that of domestic RLAN routers, which do not require any permits beyond those necessary for the use of radio spectrum, and considering the positive impact of such access points on the use of radio spectrum and on the development of wireless communications, any restriction to their deployment should be limited to the greatest extent possible. As a result, in order to facilitate the deployment of small-area wireless access points, and without prejudice to any applicable requirement related to radio spectrum management, Member States should not subject to any individual permits the deployment of such devices on buildings which are not officially protected as part of a designated environment or because of their special architectural or historical merit, except for reasons of public safety. To that end, their characteristics, such as maximum size, weight and emission characteristics, should be specified at Union level in a proportionate way for local deployment and to ensure a high level of protection of public health, as laid down in Recommendation 1999/519/EC. For the operation of small-area wireless access points, Article 7 of Directive 2014/53/EU should apply. This is without prejudice to private property rights set out in Union or national law. The procedure for considering permit applications should be streamlined and without prejudice to any commercial agreements and any administrative charge involved should be limited to the administrative costs relating to the processing of the application. The process of assessing a request for a permit should take as little time as possible, and in principle no longer than four months. (140) Public buildings and other public infrastructure are visited and used daily by a significant number of end-users who need connectivity to consume eGovernment, eTransport and other services. Other public infrastructure, such as street lamps, traffic lights, offer very valuable sites for deploying small cells, for instance, due to their density. Without prejudice to the possibility for competent authorities to subject the deployment of small-area wireless access points to individual prior permits, operators should have the right to access to those public sites for the purpose of adequately serving demand. Member States should therefore ensure that such public buildings and other public infrastructure are made available on reasonable conditions for the deployment of small-cells with a view to complementing Directive 2014/61/EU and without prejudice to the principles set out in this Directive. Directive 2014/61/EU follows a functional approach and imposes obligations of access to physical infrastructure only when it is part of a network and only if it is owned or used by a network operator, thereby leaving many buildings owned or used by public authorities outside its scope. On the contrary, a specific obligation is not necessary for physical infrastructure, such as ducts or poles, used for intelligent transport systems, which are owned by network operators (providers of transport services or providers of public electronic communications networks), and host parts of a network, thus falling within the scope of Directive 2014/61/EU. (141) The provisions of this Directive as regards access and interconnection apply to public electronic communications networks. Providers of electronic communications networks other than to the public do not have access or interconnection obligations under this Directive except where, in benefiting from access to public networks, they may be subject to conditions laid down by Member States. (142) The term ‘access’ has a wide range of meanings, and it is therefore necessary to define precisely how that term is used in this Directive, without prejudice to how it is used in other Union measures. An operator may own the underlying network or facilities or may rent some or all of them. (143) In an open and competitive market, there should be no restrictions that prevent undertakings from negotiating access and interconnection arrangements between themselves, in particular on cross-border agreements, subject to the competition rules laid down in the TFEU. In the context of achieving a more efficient, truly pan-European market, with effective competition, more choice and competitive services to end-users, undertakings which receive requests for access or interconnection from other undertakings that are subject to general authorisation in order to provide electronic communications networks or services to the public should in principle conclude such agreements on a commercial basis, and negotiate in good faith. (144) In markets where there continue to be large differences in negotiating power between undertakings, and where some undertakings rely on infrastructure provided by others for delivery of their services, it is appropriate to establish a regulatory framework to ensure that the market functions effectively. National regulatory authorities should have the power to secure, where commercial negotiation fails, adequate access and interconnection and interoperability of services in the interest of end-users. In particular, they can ensure end-to-end connectivity by imposing proportionate obligations on undertakings that are subject to the general authorisation and that control access to end-users. Control of means of access may entail ownership or control of the physical link to the end-user (either fixed or mobile), or the ability to change or withdraw the national number or numbers needed to access an end-user’s network termination point. This would be the case for example if network operators were to restrict unreasonably end-user choice for access to internet portals and services. (145) In light of the principle of non-discrimination, national regulatory authorities should ensure that all undertakings, irrespective of their size and business model, whether vertically integrated or separated, can interconnect on reasonable terms and conditions, with a view to providing end-to-end connectivity and access to the internet. (146) National legal or administrative measures that link the terms and conditions for access or interconnection to the activities of the party seeking interconnection, and specifically to the degree of its investment in network infrastructure, and not to the interconnection or access services provided, may cause market distortion and may therefore not be compatible with competition rules. (147) Network operators who control access to their own customers do so on the basis of unique numbers or addresses from a published numbering or addressing range. Other network operators need to be able to deliver traffic to those customers, and so need to be able to interconnect directly or indirectly to each other. It is therefore appropriate to lay down rights and obligations to negotiate interconnection. (148) Interoperability is of benefit to end-users and is an important aim of that regulatory framework. Encouraging interoperability is one of the objectives for national regulatory and other competent authorities as set out in that framework. That framework also provides for the Commission to publish a list of standards or specifications covering the provision of services, technical interfaces or network functions, as the basis for encouraging harmonisation in electronic communications. Member States should encourage the use of published standards or specifications to the extent strictly necessary to ensure interoperability of services and to improve freedom of choice for users. (149) Currently both end-to-end connectivity and access to emergency services depend on end-users using number-based interpersonal communications services. Future technological developments or an increased use of number-independent interpersonal communications services could entail a lack of sufficient interoperability between communications services. As a consequence, significant barriers to market entry and obstacles to further onward innovation could emerge and appreciably threaten effective end-to-end connectivity between end-users. (150) Where such interoperability issues arise, the Commission should be able to request a BEREC report which should provide a factual assessment of the market situation at Union and Member State level. Taking utmost account of the BEREC report and other available evidence and taking into account the effects on the internal market, the Commission should decide whether there is a need for regulatory intervention by national regulatory or other competent authorities. If the Commission considers that such regulatory intervention should be considered by national regulatory or other competent authorities, it should be able to adopt implementing measures specifying the nature and scope of possible regulatory interventions by national regulatory or other competent authorities, including in particular obligations to publish and allow the use, modification and redistribution of relevant information by the authorities and other providers and measures to impose the mandatory use of standards or specifications on all or specific providers. (151) National regulatory or other competent authorities should assess, in light of the specific national circumstances, whether any intervention is necessary and justified to ensure end-to-end-connectivity, and if so, impose proportionate obligations, in accordance with the Commission’s implementing measures, on those providers of number-independent interpersonal communications services with a significant level of coverage and user-uptake. The term significant should be interpreted in the sense that the geographic coverage and the number of end-users of the provider concerned represent a critical mass with a view to achieving the goal of ensuring end-to-end connectivity between end-users. Providers with a limited number of end-users or limited geographic coverage which would contribute only marginally to achieving that goal, should normally not be subject to such interoperability obligations. (152) In situations where undertakings are deprived of access to viable alternatives to non-replicable wiring, cables and associated facilities inside buildings or up to the first concentration or distribution point and in order to promote competitive outcomes in the interest of end-users, national regulatory authorities should be empowered to impose access obligations on all undertakings, irrespective of a designation as having significant market power. In that regard, national regulatory authorities should take into consideration all technical and economic barriers to future replication of networks. However, as such obligations can in certain cases be intrusive, can undermine incentives for investments, and can have the effect of strengthening the position of dominant players, they should be imposed only where justified and proportionate to achieving sustainable competition in the relevant markets. The mere fact that more than one such infrastructure already exists should not necessarily be interpreted as showing that its assets are replicable. If necessary in combination with such access obligations, undertakings should also be able to rely on the obligations to provide access to physical infrastructure on the basis of Directive 2014/61/EU. Any obligations imposed by the national regulatory authority under this Directive and decisions taken by other competent authorities under Directive 2014/61/EU to ensure access to in-building physical infrastructure or to physical infrastructure up to the access point should be consistent. (153) National regulatory authorities should be able, to the extent necessary, to impose obligations on undertakings to provide access to the facilities referred to in an annex to this Directive, namely application programming interfaces (APIs) and electronic programme guides (EPGs), to ensure not only accessibility for end-users to digital radio and television broadcast services but also to related complementary services. Such complementary services should be able to include programme related services which are specifically designed to improve accessibility for end-users with disabilities, and programme related connected television services. (154) It is important that when national regulatory authorities assess the concentration or distribution point up to which they intend to impose access, they choose a point in accordance with BEREC guidelines. Selecting a point nearer to end-users will be more beneficial to infrastructure competition and the roll-out of very high capacity networks. In this way the national regulatory authority should first consider choosing a point in a building or just outside a building. It could be justified to extend access obligations to wiring and cables beyond the first concentration or distribution point while confining such obligations to points as close as possible to end-users capable of hosting a sufficient number of end-users, where it is demonstrated that replication faces high and non-transitory physical or economic barriers, leading to important competition problems or market failures at the retail level to the detriment of end-users. The assessment of the replicability of network elements requires a market review which is different from an analysis assessing significant market power, and so the national regulatory authority does not need to establish significant market power in order to impose these obligations. On the other hand, such review requires a sufficient economic assessment of market conditions, to establish whether the criteria necessary to impose obligations beyond the first concentration or distribution point are met. Such extended access obligations are more likely to be necessary in geographical areas where the business case for alternative infrastructure rollout is more risky, for example because of low population density or because of the limited number of multi-dwelling buildings. Conversely, a high concentration of households might indicate that the imposition of such obligations is unnecessary. National regulatory authorities should also consider whether such obligations have the potential to strengthen the position of undertakings designated as having significant market power. National regulatory authorities should be able to impose access to active or virtual network elements used for service provision on such infrastructure if access to passive elements would be economically inefficient or physically impracticable, and if the national regulatory authority considers that, absent such an intervention, the purpose of the access obligation would be circumvented. In order to enhance consistent regulatory practice across the Union, the Commission should be able to require the national regulatory authority to withdraw its draft measures extending access obligations beyond the first concentration or distribution point, where BEREC shares the Commission’s serious doubts as to the compatibility of the draft measure with Union law and in particular the regulatory objectives of this Directive. (155) In such cases, in order to comply with the principle of proportionality, it can be appropriate for national regulatory authorities to exempt certain categories of owners or undertakings, or both, from obligations going beyond the first concentration or distribution point, which should be determined by national regulatory authorities, on the grounds that an access obligation not based on an undertaking’s designation as having significant market power would risk compromising their business case for recently deployed network elements, in particular by small local projects. Wholesale-only undertakings should not be subject to such access obligations if they offer an effective alternative access on a commercial basis to a very high capacity network, on fair, non-discriminatory and reasonable terms and conditions, including as regards price. It should be possible to extend that exemption to other providers on the same terms. The exemption may not be appropriate for providers that are in receipt of public funding. (156) Sharing of passive infrastructure used in the provision of wireless electronic communications services in compliance with competition law principles can be particularly useful to maximise very high capacity connectivity throughout the Union, especially in less dense areas where replication is impracticable and end-users risk being deprived of such connectivity. National regulatory or other competent authorities should, by way of exception, be able to impose such sharing or localised roaming access, in accordance with Union law, if that possibility has been clearly established in the original conditions for the granting of the right of use and they demonstrate the benefits of such sharing in terms of overcoming insurmountable economic or physical obstacles and access to networks or services is therefore severely deficient or absent, and taking into account several factors, including in particular the need for coverage along major transport paths, choice and a higher quality of service for end-users as well as the need to maintain infrastructure roll-out incentives. In circumstances where there is no access by end-users, and sharing of passive infrastructure alone does not suffice to address the situation, the national regulatory authorities should be able to impose obligations on the sharing of active infrastructure. In so doing, national regulatory or other competent authorities retain the flexibility to choose the most appropriate sharing or access obligation which should be proportionate and justified based on the nature of the problem identified. (157) While it is appropriate in some circumstances for a national regulatory or other competent authority to impose obligations on undertakings irrespective of a designation of significant market power in order to achieve goals such as end-to-end connectivity or interoperability of services, it is necessary to ensure that such obligations are imposed in accordance with the regulatory framework and, in particular, its notification procedures. Such obligations should be imposed only where justified in order to secure the objectives of this Directive, and where they are objectively justified, transparent, proportionate and non-discriminatory for the purpose of promoting efficiency, sustainable competition, efficient investment and innovation, and giving the maximum benefit to end-users, and imposed in accordance with the relevant notification procedures. (158) In order to overcome insurmountable economic or physical obstacles for providing end-users with services or networks which rely on the use of radio spectrum and where mobile coverage gaps persist, their closing may require the access and sharing of passive infrastructure, or, where this is not sufficient, the sharing of active infrastructure, or localised roaming access agreements. Without prejudice to sharing obligations attached to the rights of use on the basis of other provisions of this Directive, and in particular measures to promote competition, where national regulatory or other competent authorities intend to take measures to impose the sharing of passive infrastructure, or when passive access and sharing are not sufficient, active infrastructure sharing or localised roaming access agreements, they may, however, also be called to consider the possible risk for market participants in underserved areas. (159) Competition rules alone may not always be sufficient to ensure cultural diversity and media pluralism in the area of digital television. Technological and market developments make it necessary to review obligations to provide conditional access on fair, reasonable and non-discriminatory terms on a regular basis, by a Member State for its national market, in particular to determine whether it is justified to extend obligations to EPGs and APIs, to the extent necessary to ensure accessibility for end-users to specified digital broadcasting services. Member States should be able to specify the digital broadcasting services to which access by end-users is to be ensured by any legislative, regulatory or administrative means that they consider to be necessary. (160) Member States should also be able to permit their national regulatory authority to review obligations in relation to conditional access to digital broadcasting services in order to assess through a market analysis whether to withdraw or amend conditions for undertakings that do not have significant market power on the relevant market. Such a withdrawal or amendment should not adversely affect access for end-users to such services or the prospects for effective competition. (161) There is a need for ex ante obligations in certain circumstances in order to ensure the development of a competitive market, the conditions of which favour the deployment and take-up of very high capacity networks and services, and the maximisation of end-user benefits. The definition of significant market power used in this Directive is equivalent to the concept of dominance as defined in the case-law of the Court of Justice. (162) Two or more undertakings can be found to enjoy a joint dominant position not only where there exist structural or other links between them but also where the structure of the relevant market is conducive to coordinated effects, that is, it encourages parallel or aligned anti-competitive behaviour on the market. (163) It is essential that ex ante regulatory obligations should be imposed on a wholesale market only where there are one or more undertakings with significant market power, with a view to ensuring sustainable competition and where Union and national competition law remedies are not sufficient to address the problem. The Commission has drawn up guidelines at Union level in accordance with the principles of competition law for national regulatory authorities to follow in assessing whether competition is effective in a given market and in assessing significant market power. National regulatory authorities should analyse whether a given product or service market is effectively competitive in a given geographical area, which could be the whole or a part of the territory of the Member State concerned or neighbouring parts of territories of Member States considered together. An analysis of effective competition should include an analysis as to whether the market is prospectively competitive, and thus whether any lack of effective competition is durable. Those guidelines should also address the issue of newly emerging markets, where de facto the market leader is likely to have a substantial market share but should not be subjected to inappropriate obligations. The Commission should review the guidelines regularly, in particular on the occasion of a review of the existing law, taking into account the case-law of the Court of Justice, economic thinking and actual market experience and with a view to ensuring that they remain appropriate in a rapidly developing market. National regulatory authorities will need to cooperate with each other where the relevant market is found to be transnational. (164) In determining whether an undertaking has significant market power in a specific market, national regulatory authorities should act in accordance with Union law and take utmost account of the Commission guidelines on market analysis and the assessment of significant market power. (165) National regulatory authorities should define relevant geographic markets within their territory taking into utmost account the Commission Recommendation on relevant product and service markets (the ‘Recommendation’) adopted pursuant to this Directive and taking into account national and local circumstances. Therefore, national regulatory authorities should at least analyse the markets that are contained in the Recommendation, including those markets that are listed but no longer regulated in the specific national or local context. National regulatory authorities should also analyse markets that are not contained in that Recommendation, but that are regulated within the territory of their jurisdiction on the basis of previous market analyses, or other markets, if they have sufficient grounds to consider that the three criteria provided in this Directive are met. (166) Transnational markets can be defined when it is justified by the geographic market definition, taking into account all supply-side and demand-side factors in accordance with competition law principles. BEREC is the most appropriate body to undertake such analysis, benefiting from the extensive collective experience of national regulatory authorities when defining markets on a national level. National circumstances should be taken into account when an analysis of potential transnational markets is undertaken. If transnational markets are defined and warrant regulatory intervention, concerned national regulatory authorities should cooperate to identify the appropriate regulatory response, including in the process of notification to the Commission. They can also cooperate in the same manner where transnational markets are not identified but on their territories market conditions are sufficiently homogeneous to benefit from a coordinated regulatory approach, such as for example in terms of similar costs, market structures or operators, or in the case of transnational or comparable end-user demand. (167) In some circumstances geographic markets are defined as national or sub-national, for example due to the national or local nature of network roll-out which determines the boundaries of undertakings’ potential market power in respect of wholesale supply, but there is still a significant transnational demand from one or more categories of end-users. That can in particular be the case for demand from business end-users with multisite facility operations in different Member States. If that transnational demand is not sufficiently met by suppliers, for example if they are fragmented along national borders or locally, a potential internal market barrier arises. Therefore, BEREC should be empowered to provide guidelines to national regulatory authorities on common regulatory approaches to ensure that transnational demand can be met in a satisfactory way, providing a basis for the interoperability of wholesale access products across the Union and permitting efficiencies and economies of scale despite the fragmented supply side. BEREC’s guidelines should shape the choices of national regulatory authorities in pursuing the internal market objective when imposing regulatory obligations on undertakings designated as having significant market power at national level while providing guidance for the harmonisation of technical specifications of wholesale access products capable of meeting such identified transnational demand, in the interest of the internal market. (168) The objective of any ex ante regulatory intervention is ultimately to produce benefits for end-users in terms of price, quality and choice by making retail markets effectively competitive on a sustainable basis. It is likely that national regulatory authorities will gradually be able to find many retail markets to be competitive even in the absence of wholesale regulation, especially taking into account expected improvements in innovation and competition. (169) For national regulatory authorities, the starting point for the identification of wholesale markets susceptible to ex ante regulation is the analysis of corresponding retail markets. The analysis of effective competition at the retail and at the wholesale level is conducted from a forward-looking perspective over a given time horizon, and is guided by competition law, including, as appropriate, the relevant case law of the Court of Justice. If it is concluded that a retail market would be effectively competitive in the absence of ex ante wholesale regulation on the corresponding relevant markets, this should lead the national regulatory authority to conclude that regulation is no longer needed at the relevant wholesale level. (170) During the gradual transition to deregulated markets, commercial agreements, including for co-investment and access between operators will gradually become more common, and if they are sustainable and improve competitive dynamics, they can contribute to the conclusion that a particular wholesale market does not warrant ex ante regulation. A similar logic would apply in reverse, to the unforeseeable termination of commercial agreements on a deregulated market. The analysis of such agreements should take into account that the prospect of regulation can be a motive for network owners to enter into commercial negotiations. With a view to ensuring adequate consideration of the impact of regulation imposed on related markets when determining whether a given market warrants ex ante regulation, national regulatory authorities should ensure markets are analysed in a consistent manner and where possible, at the same time or as close as possible to each other in time. (171) When assessing wholesale regulation to solve problems at the retail level, national regulatory authorities should take into account the fact that several wholesale markets can provide wholesale upstream inputs for a particular retail market, and, conversely, that a single wholesale market can provide wholesale upstream inputs for a variety of retail markets. Furthermore, competitive dynamics in a particular market can be influenced by markets that are contiguous but not in a vertical relationship, such as can be the case between certain fixed and mobile markets. National regulatory authorities should conduct that assessment for each individual wholesale market considered for regulation, starting with remedies for access to civil infrastructure, as such remedies are usually conducive to more sustainable competition including infrastructure competition, and thereafter analysing any wholesale markets considered susceptible to ex ante regulation in order of their likely suitability to address identified competition problems at retail level. When deciding on the specific remedy to be imposed, national regulatory authorities should assess its technical feasibility and carry out a cost-benefit analysis, having regard to its degree of suitability to address the identified competition problems at retail level, and enabling competition based on differentiation and technology neutrality. National regulatory authorities should consider the consequences of imposing any specific remedy which, if feasible only on certain network topologies, could constitute a disincentive for the deployment of very high capacity networks in the interest of end-users. (172) Without prejudice to the principle of technology neutrality, the national regulatory authorities should provide incentives through the remedies imposed, and, where possible, before the roll-out of infrastructure, for the development of flexible and open network architecture, which would reduce eventually the burden and complexity of remedies imposed at a later stage. At each stage of the assessment, before the national regulatory authority determines whether any additional, more burdensome, remedy should be imposed on the undertaking designated as having significant market power, it should seek to determine whether the retail market concerned would be effectively competitive, also taking into account any relevant commercial arrangements or other wholesale market circumstances, including other types of regulation already in force, such as for example general access obligations to non-replicable assets or obligations imposed pursuant to Directive 2014/61/EU, and of any regulation already considered to be appropriate by the national regulatory authority for an undertaking designated as having significant market power. Such an assessment, aiming to ensure that only the most appropriate remedies necessary to effectively address any problems identified in the market analysis are imposed, does not preclude a national regulatory authority from finding that a mix of such remedies together, even if of differing intensity, in line with the proportionality principle, offers the least intrusive way of addressing the problem. Even if such differences do not result in the definition of distinct geographic markets, they should be able to justify differentiation in the appropriate remedies imposed in light of the differing intensity of competitive constraints. (173) Ex ante regulation imposed at the wholesale level, which is in principle less intrusive than retail regulation, is considered to be sufficient to tackle potential competition problems on the related downstream retail market or markets. The advances in the functioning of competition since the regulatory framework for electronic communications has been in place are demonstrated by the progressive deregulation of retail markets across the Union. Furthermore, the rules relating to the imposition of ex ante remedies on undertakings designated as having significant market power should, where possible, be simplified and be made more predictable. Therefore, the imposition of ex ante regulatory controls based on an undertaking’s designation as having significant market power in wholesale markets should prevail. (174) When a national regulatory authority withdraws wholesale regulation, it should define an appropriate notice period to ensure a sustainable transition to a de-regulated market. In defining such a notice period, the national regulatory authority should take into account the existing agreements between access providers and access seekers that have been entered into on the basis of the imposed regulatory obligations. In particular, such agreements can provide a contractual legal protection to access seekers for a determined period. The national regulatory authority should also take into account the effective possibility for market participants to take up any commercial wholesale access or co-investment offers which can be present in the market and the need to avoid an extended period of possible regulatory arbitrage. Transition arrangements established by the national regulatory authority should consider the extent and timing of regulatory oversight of pre-existing agreements, once the notice period starts. (175) In order to provide market players with certainty as to regulatory conditions, a time limit for market reviews is necessary. It is important to conduct a market analysis on a regular basis and within a reasonable and appropriate time-frame. There is a risk that failure by a national regulatory authority to analyse a market within the time-limit jeopardises the internal market, and normal infringement proceedings do not produce their desired effect on time. Alternatively, the national regulatory authority concerned should be able to request the assistance of BEREC to complete the market analysis. Such assistance could, for example, take the form of a specific task force composed of representatives of other national regulatory authorities. (176) Due to the high level of technological innovation and highly dynamic markets in the electronic communications sector, there is a need to adapt regulation rapidly in a coordinated and harmonised way at Union level, as experience has shown that divergence among the national regulatory authorities in the implementation of the regulatory framework may create a barrier to the internal market. (177) However, in the interest of greater stability and predictability of regulatory measures, the maximum period allowed between market analyses should be extended from three to five years, provided market changes in the intervening period do not require a new analysis. In determining whether a national regulatory authority has complied with its obligation to analyse markets and notified the corresponding draft measure at a minimum every five years, only a notification including a new assessment of the market definition and of significant market power will be considered to be starting a new five-year market cycle. A mere notification of new or amended regulatory remedies, imposed on the basis of a previous and unrevised market analysis will not be considered to have satisfied that obligation. Non-compliance by a national regulatory authority with the obligation to conduct market analysis at regular intervals laid down in this Directive should not be considered, in itself, to be a ground for the invalidity or inapplicability of existing obligations imposed by that national regulatory authority in the market in question. (178) The imposition of a specific obligation on an undertaking designated as having significant market power does not require an additional market analysis but rather a justification that the obligation in question is appropriate and proportionate in relation to the nature of the problem identified on the market in question, and on the related retail market. (179) When assessing the proportionality of the obligations and conditions to be imposed, national regulatory authorities should take into account the different competitive conditions existing in the different areas within their Member States having regard in particular to the results of the geographical survey conducted in accordance with this Directive. (180) When considering whether to impose remedies to control prices, and if so in what form, national regulatory authorities should seek to allow a fair return for the investor on a particular new investment project. In particular, there are risks associated with investment projects specific to new access networks which support products for which demand is uncertain at the time the investment is made. (181) Reviews of obligations imposed on undertakings designated as having significant market power during the timeframe of a market analysis should allow national regulatory authorities to take into account the impact on competitive conditions of new developments, for instance of newly concluded voluntary agreements between undertakings, such as access and co-investment agreements, thus providing the flexibility which is particularly necessary in the context of longer regulatory cycles. A similar logic should apply in the case of an unforeseeable breach or termination of a commercial agreement, or if such an agreement has effects diverging from the market analysis. If the termination of an existing agreement occurs in a deregulated market, it is possible that a new market analysis is required. In the absence of a single important change in the market but in the case of dynamic markets, it may be necessary to conduct a market analysis more often than every five years, for example not earlier than every three years as was the case until the date of application of this Directive. Markets should be considered to be dynamic if the technological evolution and end-user demand patterns are likely to evolve in such a way that the conclusions of the analysis would be superseded within the medium term for a significant group of geographic areas or of end-users within the geographic and product market defined by the national regulatory authority. (182) Transparency of terms and conditions for access and interconnection, including prices, serve to speed up negotiation, avoid disputes and give confidence to market players that a service is not being provided on discriminatory terms. Openness and transparency of technical interfaces can be particularly important in ensuring interoperability. Where a national regulatory authority imposes obligations to make information public, it should also be able to specify the manner in which the information is to be made available, and whether it is free of charge, taking into account the nature and purpose of the information concerned. (183) In light of the variety of network topologies, access products and market circumstance that have arisen since 2002, the objectives of Annex II to Directive 2002/19/EC, concerning local loop unbundling, and access products for providers of digital television and radio services, can be better achieved and in a more flexible manner, by providing guidelines on the minimum criteria for a reference offer to be developed by and periodically updated by BEREC. That Annex should therefore be deleted. (184) The principle of non-discrimination ensures that undertakings with significant market power do not distort competition, in particular where they are vertically integrated undertakings that supply services to undertakings with whom they compete on downstream markets. (185) In order to address and prevent non-price related discriminatory behaviour, equivalence of inputs (EoI) is in principle the surest way of achieving effective protection from discrimination. On the other hand, providing regulated wholesale inputs on an EoI basis is likely to trigger higher compliance costs than other forms of non-discrimination obligations. Those higher compliance costs should be measured against the benefits of more vigorous competition downstream, and of the relevance of non-discrimination guarantees in circumstances where the undertaking designated as having significant market power is not subject to direct price controls. In particular, national regulatory authorities might consider that the provision of wholesale inputs over new systems on an EoI basis is more likely to create sufficient net benefits, and thus be proportionate, given the comparatively lower incremental compliance costs to ensure that newly built systems are EoI-compliant. On the other hand, national regulatory authorities should also consider whether obligations are proportionate for affected undertakings, for example, by taking into account implementation costs and weigh up possible disincentives to the deployment of new systems, relative to more incremental upgrades, in the event that the former would be subject to more restrictive regulatory obligations. In Member States with a high number of small-scale undertakings designated as having significant market power, the imposition of EoI on each of those undertakings can be disproportionate. (186) Accounting separation allows internal price transfers to be rendered visible, and allows national regulatory authorities to check compliance with obligations for non-discrimination where applicable. In this regard the Commission published Recommendation 2005/698/EC (35). (187) Civil engineering assets that can host an electronic communications network are crucial for the successful roll-out of new networks because of the high cost of duplicating them, and the significant savings that can be made when they can be reused. Therefore, in addition to the rules on physical infrastructure laid down in Directive 2014/61/EU, a specific remedy is necessary in those circumstances where civil engineering assets are owned by an undertaking designated as having significant market power. Where civil engineering assets exist and are reusable, the positive effect of achieving effective access to them on the roll-out of competing infrastructure is very high, and it is therefore necessary to ensure that access to such assets can be used as a self-standing remedy for the improvement of competitive and deployment dynamics in any downstream market, to be considered before assessing the need to impose any other potential remedies, and not just as an ancillary remedy to other wholesale products or services or as a remedy limited to undertakings availing themselves of such other wholesale products or services. National regulatory authorities should value reusable legacy civil engineering assets on the basis of the regulatory accounting value net of the accumulated depreciation at the time of calculation, indexed by an appropriate price index, such as the retail price index, and excluding those assets which are fully depreciated, over a period of not less than 40 years, but still in use. (188) National regulatory authorities should, when imposing obligations for access to new and enhanced infrastructures, ensure that access conditions reflect the circumstances underlying the investment decision, taking into account, inter alia, the roll-out costs, the expected rate of take up of the new products and services and the expected retail price levels. Moreover, in order to provide planning certainty to investors, national regulatory authorities should be able to set, if applicable, terms and conditions for access which are consistent over appropriate review periods. In the event that price controls are considered to be appropriate, such terms and conditions can include pricing arrangements which depend on volumes or length of contract in accordance with Union law and provided they have no discriminatory effect. Any access conditions imposed should respect the need to preserve effective competition in services to consumers and businesses. (189) Mandating access to network infrastructure can be justified as a means of increasing competition, but national regulatory authorities need to balance the rights of an infrastructure owner to exploit its infrastructure for its own benefit, and the rights of other service providers to access facilities that are essential for the provision of competing services. (190) In markets where an increased number of access networks can be expected on a forward-looking basis, end-users are more likely to benefit from improvements in network quality, by virtue of infrastructure-based competition, compared to markets where only one network persists. The adequacy of competition on other parameters, such as price and choice, is likely to depend on the national and local competitive circumstances. In assessing the adequacy of competition on such parameters and the need for regulatory intervention, national regulatory authorities should also take into account whether wholesale access is available to any interested undertaking on reasonable commercial terms permitting sustainable competitive outcomes for end-users on the retail market. The application of general competition rules in markets characterised by sustainable and effective infrastructure-based competition should be sufficient. (191) Where obligations are imposed on undertakings that require them to meet reasonable requests for access to and use of networks elements and associated facilities, such requests should be refused only on the basis of objective criteria such as technical feasibility or the need to maintain network integrity. Where access is refused, the aggrieved party should be able to submit the case to the dispute resolutions procedures under this Directive. An undertaking with mandated access obligations cannot be required to provide types of access which it is not within its power to provide. The imposition by national regulatory authorities of mandated access that increases competition in the short term should not reduce incentives for competitors to invest in alternative facilities that will secure more sustainable competition or higher performance and end-user benefits in the long term. When choosing the least intrusive regulatory intervention, and in line with the principle of proportionality, national regulatory authorities could, for example, decide to review the obligations imposed on undertakings designated as having significant market power and amend any previous decision, including by withdrawing obligations, imposing or not imposing new access obligations if this is in the interests of users and sustainable service competition. National regulatory authorities should be able to impose technical and operational conditions on the provider or beneficiaries of mandated access in accordance with Union law. In particular the imposition of technical standards should comply with Directive (EU) 2015/1535. (192) Price control may be necessary when market analysis in a particular market reveals inefficient competition. In particular, undertakings designated as having significant market power should avoid a price squeeze whereby the difference between their retail prices and the interconnection or access prices charged to competitors who provide similar retail services is not adequate to ensure sustainable competition. When a national regulatory authority calculates costs incurred in establishing a service mandated under this Directive, it is appropriate to allow a reasonable return on the capital employed including appropriate labour and building costs, with the value of capital adjusted where necessary to reflect the current valuation of assets and efficiency of operations. The method of cost recovery should be appropriate to the circumstances taking account of the need to promote efficiency, sustainable competition and deployment of very high capacity networks and thereby maximise end-user benefits, and should take in account the need to have predictable and stable wholesale prices for the benefit of all operators seeking to deploy new and enhanced networks, in accordance with Commission Recommendation 2013/466/EU (36). (193) Due to uncertainty regarding the rate of materialisation of demand for the provision of next-generation broadband services, it is important in order to promote efficient investment and innovation to allow those operators investing in new or upgraded networks a certain degree of pricing flexibility. National regulatory authorities should be able to decide to maintain or not to impose regulated wholesale access prices on next-generation networks if sufficient competition safeguards are present. More specifically, to prevent excessive prices in markets where there are undertakings designated as having significant market power, pricing flexibility should be accompanied by additional safeguards to protect competition and end-user interests, such as strict non-discrimination obligations, measures to ensure technical and economic replicability of downstream products, and a demonstrable retail price constraint resulting from infrastructure competition or a price anchor stemming from other regulated access products, or both. Those competitive safeguards do not prejudice the identification by national regulatory authorities of other circumstances under which it would be appropriate not to impose regulated access prices for certain wholesale inputs, such as where high price elasticity of end-user demand makes it unprofitable for the undertaking designated as having significant market power to charge prices appreciably above the competitive level or where lower population density reduces the incentives for the development of very high capacity networks and the national regulatory authority establishes that effective and non-discriminatory access is ensured through obligations imposed in accordance with this Directive. (194) Where a national regulatory authority imposes obligations to implement a cost-accounting system in order to support price controls, it should be able to undertake an annual audit to ensure compliance with that cost-accounting system, provided that it has the necessary qualified staff, or to require such an audit to be carried out by another qualified body, independent of the undertaking concerned. (195) The charging system in the Union for wholesale voice call termination is based on Calling Party Network Pays. An analysis of demand and supply substitutability shows that currently or in the foreseeable future, there are no substitutes at wholesale level which might constrain the setting of charges for termination in a given network. Taking into account the two-way access nature of termination markets, further potential competition problems include cross-subsidisation between operators. Those potential competition problems are common to both fixed and mobile voice call termination markets. Therefore, in light of the ability and incentives of terminating operators to raise prices substantially above cost, cost orientation is considered to be the most appropriate intervention to address this concern over the medium term. Future market developments may alter the dynamics of those markets to the extent that regulation would no longer be necessary. (196) In order to reduce the regulatory burden in addressing the competition problems relating to wholesale voice call termination consistently across the Union, the Commission should establish, by means of a delegated act, a single maximum voice termination rate for mobile services and a single maximum voice termination rate for fixed services that apply Union-wide. (197) This Directive should lay down the detailed criteria and parameters on the basis of which the values of voice call termination rates are set. Termination rates across the Union have decreased consistently and are expected to continue to do so. When the Commission determines the maximum termination rates in the first delegated act that it adopts pursuant to this Directive, it should disregard any unjustified exceptional national deviation from that trend. (198) Due to current uncertainty regarding the rate of materialisation of demand for very high capacity broadband services as well as general economies of scale and density, co-investment agreements offer significant benefits in terms of pooling of costs and risks, enabling smaller-scale undertakings to invest on economically rational terms and thus promoting sustainable, long-term competition, including in areas where infrastructure-based competition might not be efficient. Such co-investments can take different forms, including co-ownership of network assets or long-term risk sharing through co-financing or through purchase agreements. In that context, purchase agreements which constitute co-investments entail the acquisition of specific rights to capacity of a structural character, involving a degree of co-determination and enabling co-investors to compete effectively and sustainably in the long term in downstream markets in which the undertaking designated as having significant market power is active. By contrast, commercial access agreements that are limited to the rental of capacity do not give rise to such rights and therefore should not be considered to be co-investments. (199) Where an undertaking designated as having significant market power makes an offer for co-investment on fair, reasonable and non-discriminatory terms in very high capacity networks that consist of optical fibre elements up to the end-user premises or the base station, providing an opportunity to undertakings of different sizes and financial capacity to become infrastructure co-investors, the national regulatory authority should be able to refrain from imposing obligations pursuant to this Directive on the new very high capacity network if at least one potential co-investor has entered into a co-investment agreement with that undertaking. Where a national regulatory authority decides to make binding a co-investment offer that has not resulted in an agreement, and decides, not to impose additional regulatory obligations, it can do so, subject to the condition that such an agreement is to be concluded before the deregulatory measure takes effect. Where it is technically impracticable to deploy optical fibre elements up to the end-user’s premises, very high capacity networks consisting of optical fibre elements up to the immediate proximity of, meaning just outside, such premises should also be able to benefit from the same regulatory treatment. (200) When making a determination to refrain from imposing obligations, the national regulatory authority should take such steps after ensuring that the co-investment offers comply with the necessary criteria and are made in good faith. The differential regulatory treatment of new very high capacity networks should be subject to review in subsequent market analyses which, in particular after some time has elapsed, may require adjustments to the regulatory treatment. In duly justified circumstances, national regulatory authorities should be able to impose obligations on such new network elements when they establish that certain markets would, in the absence of regulatory intervention, face significant competition problems. In particular, when there are multiple downstream markets that have not reached the same degree of competition, national regulatory authorities could require specific asymmetric remedies to promote effective competition, for instance, but not limited to, niche retail markets, such as electronic communications products for business end-users. To maintain the competitiveness of the markets, national regulatory authorities should also safeguard the rights of access seekers who do not participate in a given co-investment. This should be achieved through the maintenance of existing access products or, where legacy network elements are dismantled in due course, through the imposition of access products with at least comparable functionality and quality to those previously available on the legacy infrastructure, in both cases subject to an appropriate adaptable mechanism validated by the national regulatory authority that does not undermine the incentives for co-investors. (201) In order to enhance the consistent regulatory practice across the Union, where national regulatory authorities conclude that the conditions of the co-investment offer are met, the Commission should be able to require the national regulatory authority to withdraw its draft measures either refraining from imposing obligations or intervening with regulatory obligations in order to address significant competition problems, where BEREC shares the Commission’s serious doubts as to the compatibility of the draft measure with Union law and in particular the regulatory objectives of this Directive. In the interest of efficiency, a national regulatory authority should be able to submit a single notification to the Commission of a draft measure that relates to a co-investment scheme that meets the relevant conditions. Where the Commission does not exercise its powers to require the withdrawal of the draft measure, it would be disproportionate for subsequent simplified notifications of individual draft decisions of the national regulatory authority on the basis of the same scheme, including in addition evidence of actual conclusion of an agreement with at least one co-investor, to be subject to a decision requiring withdrawal in the absence of a change in circumstances. Furthermore, obligations imposed on undertakings, irrespective of whether they are designated as having significant market power, pursuant to this Directive or to Directive 2014/61/EU continue to apply. Obligations in relation to co-investment agreements are without prejudice to the application of Union law. (202) The purpose of functional separation, whereby the vertically integrated undertaking is required to establish operationally separate business entities, is to ensure the provision of fully equivalent access products to all downstream operators, including the operator’s own vertically integrated downstream divisions. Functional separation has the capacity to improve competition in several relevant markets by significantly reducing the incentive for discrimination and by making it easier to verify and enforce compliance with non-discrimination obligations. In exceptional cases, it should be possible for functional separation to be justified as a remedy where there has been persistent failure to achieve effective non-discrimination in several of the markets concerned, and where there is little or no prospect of infrastructure competition within a reasonable time-frame after recourse to one or more remedies previously considered to be appropriate. However, it is very important to ensure that its imposition preserves the incentives of the undertaking concerned to invest in its network and that it does not entail any potential negative effects on consumer welfare. Its imposition requires a coordinated analysis of different relevant markets related to the access network, in accordance with the market analysis procedure. When undertaking the market analysis and designing the details of that remedy, national regulatory authorities should pay particular attention to the products to be managed by the separate business entities, taking into account the extent of network roll-out and the degree of technological progress, which may affect the substitutability of fixed and wireless services. In order to avoid distortions of competition in the internal market, proposals for functional separation should be approved in advance by the Commission. (203) The implementation of functional separation should not prevent appropriate coordination mechanisms between the different separate business entities in order to ensure that the economic and management supervision rights of the parent company are protected. (204) Where a vertically integrated undertaking chooses to transfer a substantial part or all of its local access network assets to a separate legal entity under different ownership or by establishing a separate business entity for dealing with access products, the national regulatory authority should assess the effect of the intended transaction, including any access commitments offered by this undertaking, on all existing regulatory obligations imposed on the vertically integrated undertaking in order to ensure the compatibility of any new arrangements with this Directive. The national regulatory authority concerned should undertake a new analysis of the markets in which the segregated entity operates, and impose, maintain, amend or withdraw obligations accordingly. To that end, the national regulatory authority should be able to request information from the undertaking. (205) It is already possible today in some markets that as part of the market analysis the undertakings designated as having significant market power are able to offer commitments which aim to address competition problems identified by the national regulatory authority and which the national regulatory authority then takes into account in deciding on the appropriate regulatory obligations. Any new market developments should be taken into account in deciding on the most appropriate remedies. However, and without prejudice to the provisions on regulatory treatment of co-investments, the nature of the commitments offered as such does not limit the discretion accorded to the national regulatory authority to impose remedies on undertakings designated as having significant market power. In order to enhance transparency and to provide legal certainty across the Union, the procedure for undertakings to offer commitments and for the national regulatory authorities to assess them, taking into account the views of market participants by means of a market test, and if appropriate to make them binding on the committing undertaking and enforceable by the national regulatory authority, should be laid down in this Directive. Unless the national regulatory authority has made commitments on co-investments binding and decided not to impose obligations, that procedure is without prejudice to the application of the market analysis procedure and the obligation to impose appropriate and proportionate remedies to address the identified market failure. (206) National regulatory authorities should be able to make the commitments binding, wholly or in part, for a specific period which should not exceed the period for which they are offered, after having conducted a market test by means of a public consultation of interested parties. Where the commitments have been made binding, the national regulatory authority should consider the consequences of this decision in its market analysis and take them into account when choosing the most appropriate regulatory measures. National regulatory authorities should consider the commitments made from a forward-looking perspective of sustainability, in particular when choosing the period for which they are made binding, and should have regard to the value placed by stakeholders in the public consultation on stable and predictable market conditions. Binding commitments related to voluntary separation by a vertically integrated undertaking which has been designated as having significant market power in one or more relevant markets can add predictability and transparency to the process, by setting out the process of implementation of the planned separation, for example by providing a roadmap for implementation with clear milestones and predictable consequences if certain milestones are not met. (207) The commitments can include the appointment of a monitoring trustee, whose identity and mandate should be approved by the national regulatory authority, and the obligation on the undertaking offering them to provide periodic implementation reports. (208) Network owners whose business model is limited to the provision of wholesale services to others, can be beneficial to the creation of a thriving wholesale market, with positive effects on retail competition downstream. Furthermore, their business model can be attractive to potential financial investors in less volatile infrastructure assets and with longer term perspectives on deployment of very high capacity networks. Nevertheless, the presence of a wholesale-only undertaking does not necessarily lead to effectively competitive retail markets, and wholesale-only undertakings can be designated as having significant market power in particular product and geographic markets. Certain competition risks arising from the behaviour of undertakings following wholesale-only business models might be lower than for vertically integrated undertakings, provided the wholesale-only model is genuine and no incentives to discriminate between downstream providers exist. The regulatory response should therefore be commensurately less intrusive, but should preserve in particular the possibility to introduce obligations in relation to fair and reasonable pricing. On the other hand, national regulatory authorities should be able to intervene if competition problems have arisen to the detriment of end-users. An undertaking active on a wholesale market that supplies retail services solely to business users larger than small and medium-sized enterprises should be regarded as a wholesale-only undertaking. (209) To facilitate the migration from legacy copper networks to next-generation networks, which is in the interests of end-users, national regulatory authorities should be able to monitor network operators’ own initiatives in this respect and to establish, where necessary, the conditions for an appropriate migration process, for example by means of prior notice, transparency and availability of alternative access products of at least comparable quality, once the network owner has demonstrated the intent and readiness to switch to upgraded networks. In order to avoid unjustified delays to the migration, national regulatory authorities should be empowered to withdraw access obligations relating to the copper network once an adequate migration process has been established and compliance with conditions and process for migration from legacy infrastructure is ensured. However, network owners should be able to decommission legacy networks. Access seekers migrating from an access product based on legacy infrastructure to an access product based on a more advanced technology or medium should be able to upgrade their access to any regulated product with higher capacity, but should not be required to do so. In the case of an upgrade, access seekers should adhere to the regulatory conditions for access to the higher capacity access product, as determined by the national regulatory authority in its market analysis. (210) The liberalisation of the telecommunications sector and increasing competition and choice for communications services go hand in hand with parallel action to create a harmonised regulatory framework which secures the delivery of universal service. The concept of universal service should evolve to reflect advances in technology, market developments and changes in user demand. (211) Under Article 169 TFEU, the Union is to contribute to the protection of consumers. (212) Universal service is a safety net to ensure that a set of at least the minimum services is available to all end-users and at an affordable price to consumers, where a risk of social exclusion arising from the lack of such access prevents citizens from full social and economic participation in society. (213) Basic broadband internet access is virtually universally available across the Union and very widely used for a broad range of activities. However, the overall take-up rate is lower than availability as there are still those who are disconnected due to reasons related to awareness, cost, skills and due to choice. Affordable adequate broadband internet access has become of crucial importance to society and the wider economy. It provides the basis for participation in the digital economy and society through essential online internet services. (214) A fundamental requirement of universal service is to ensure that all consumers have access at an affordable price to an available adequate broadband internet access and voice communications services, at a fixed location. Member States should also have the possibility to ensure affordability of adequate broadband internet access and voice communications services other than at a fixed location to citizens on the move, where they consider that this is necessary to ensure consumers' full social and economic participation in society. Particular attention should be paid in that context to ensuring that end-users with disabilities have equivalent access. There should be no limitations on the technical means by which the connection is provided, allowing for wired or wireless technologies, nor any limitations on the category of providers which provide part or all of universal service obligations. (215) The speed of internet access experienced by a given user depends on a number of factors, including the providers of internet connectivity as well as the given application for which a connection is being used. It is for the Member States, taking into account BEREC’s report on best practices, to define adequate broadband internet access in light of national conditions and the minimum bandwidth enjoyed by the majority of consumers within a Member State’s territory in order to allow an adequate level of social inclusion and participation in the digital economy and society in their territory. The affordable adequate broadband internet access service should have sufficient bandwidth to support access to and use of at least a minimum set of basic services that reflect the services used by the majority of end-users. To that end, the Commission should monitor the development in the use of the internet to identify those online services used by a majority of end-users across the Union and necessary for social and economic participation in society and update the list accordingly. The requirements of Union law on open internet access, in particular of Regulation (EU) 2015/2120, should apply to any adequate broadband internet access service. (216) Consumers should not be obliged to access services they do not want and it should therefore be possible for eligible consumers to restrict, on request, the affordable universal service to voice communications services. (217) Member States should be able to extend measures related to affordability and control of expenditure measures to microenterprises and small and medium-sized enterprises and not-for-profit organisations, provided they fulfil the relevant conditions. (218) National regulatory authorities in coordination with other competent authorities should be able to monitor the evolution and level of retail tariffs for services that fall within the scope of universal service obligations. Such monitoring should be carried out in such a way that it would not represent an excessive administrative burden for either national regulatory and other competent authorities or providers of such services. (219) An affordable price means a price defined by Member States at national level in light of specific national conditions. Where Member States establish that retail prices for adequate broadband internet access and voice communications services are not affordable to consumers with low-income or special social needs, including older people, end-users with disabilities and consumers living in rural or geographically isolated areas, they should take appropriate measures. To that end, Member States could provide those consumers with direct support for communication purposes, which could be part of social allowances or vouchers for, or direct payments to, those consumers. This can be an appropriate alternative having regard to the need to minimise market distortions. Alternatively, or in addition, Member States could require providers of such services to offer basic tariff options or packages to those consumers. (220) Ensuring affordability may involve special tariff options or packages to deal with the needs of low-income users or users with special social needs. Such offers should be provided with basic features, in order to avoid distortion of the functioning of the market. Affordability for individual consumers should be founded upon their right to contract with a provider, availability of a number, continued connection of service and their ability to monitor and control their expenditure. (221) Where a Member State requires providers to offer to consumers with a low-income or special social needs tariff options or packages different from those provided under normal commercial conditions, those tariff options or packages should be provided by all providers of internet access and voice communication services. In accordance with the principle of proportionality, requiring all providers of internet access and voice communication services to offer tariff options or packages should not result in excessive administrative or financial burden for those providers or Member States. Where a Member State demonstrates such an excessive administrative or financial burden, on the basis of an objective assessment, it might exceptionally decide to impose the obligation to offer specific tariff options or packages only on designated providers. The objective assessment should also consider the benefits arising for consumers with a low-income or special social needs from a choice of providers and the benefits for all providers being able to benefit from being a universal service provider. Where a Member State exceptionally decides to impose the obligation to offer specific tariff options or packages only on designated providers, they should ensure that consumers with low income or special needs have a choice of providers offering social tariffs. However, in certain situations Member States might not be able to guarantee a choice of providers, for example where only one undertaking provides services in the area of residence of the beneficiary, or if providing a choice would put an excessive additional organisational and financial burden on the Member State. (222) Affordability should no longer be a barrier to consumers’ access to the minimum set of connectivity services. A right to contract with a provider should mean that consumers who might face refusal, in particular those with a low-income or special social needs, should have the possibility to enter into a contract for the provision of affordable adequate broadband internet access and voice communications services at least at a fixed location with any provider of such services in that location or a designated provider, where a Member State has exceptionally decided to designate one or more providers to offer those tariff options or packages. In order to minimise the financial risks such as non-payment of bills, providers should be free to provide the contract under pre-payment terms, on the basis of affordable individual pre-paid units. (223) In order to ensure that citizens are reachable by voice communications services, Member States should ensure the availability of a number for a reasonable period also during periods of non-use of voice communications services. Providers should be able to put in place mechanisms to check the continued interest of the consumer in keeping the availability of the number. (224) Compensating providers of such services in such circumstances need not result in the distortion of competition, provided that such providers are compensated for the specific net cost involved and provided that the net cost burden is recovered in a competitively neutral way. (225) In order to assess the need for affordability measures, national regulatory authorities in coordination with other competent authorities should be able to monitor the evolution and details of offers of tariff options or packages for consumers with a low-income or special social needs. (226) Member States should introduce measures to promote the creation of a market for affordable products and services incorporating facilities for consumers with disabilities, including equipment with assistive technologies. This can be achieved, inter alia, by referring to European standards, or by supporting the implementation of requirements under Union law harmonising accessibility requirements for products and services. Member States should introduce appropriate measures in accordance with national circumstances, which gives flexibility for Member States to take specific measures for instance if the market is not delivering affordable products and services incorporating facilities for consumers with disabilities under normal economic conditions. Those measures could include direct financial support to end-users. The cost to consumers with disabilities of relay services should be equivalent to the average cost of voice communications services. (227) Relay services refer to services which enable two-way communication between remote end-users of different modes of communication (for example text, sign, speech) by providing conversion between those modes of communication, normally by a human operator. Real time text is defined in accordance with Union law harmonising accessibility requirements for products and services and refers to form of text conversation in point to point situations or in multipoint conferencing where the text being entered is sent in such a way that the communication is perceived by the user as being continuous on a character-by-character basis. (228) For data communications at data rates that are sufficient to permit an adequate broadband internet access, fixed-line connections are nearly universally available and used by a majority of citizens of the Union. The standard fixed broadband coverage and availability in the Union stood at 97 % of homes in 2015, with an average take-up rate of 72 %, and services based on wireless technologies have even greater reach. However, there are differences between Member States as regards availability and affordability of fixed broadband across urban and rural areas. (229) The market has a leading role to play in ensuring availability of broadband internet access with constantly growing capacity. In areas where the market would not deliver, other public policy tools to support availability of adequate broadband internet access connections appear, in principle, more cost-effective and less market-distortive than universal service obligations, for example recourse to financial instruments such as those available under the European Fund for Strategic Investments and Connecting Europe Facility, the use of public funding from the European structural and investment funds, attaching coverage obligations to rights of use for radio spectrum to support the deployment of broadband networks in less densely populated areas and public investment in accordance with Union State aid rules. (230) If, after carrying out a due assessment, taking into account the results of the geographical survey of networks deployment conducted by the competent authority, or the latest information available to the Member States before the results of the first geographical survey are available, it is shown that neither the market nor public intervention mechanisms are likely to provide end-users in certain areas with a connection capable of delivering adequate broadband internet access service as defined by Member States and voice communications services at a fixed location, the Member State should be able to exceptionally designate different providers or sets of providers of those services in the different relevant parts of the national territory. In addition to the geographical survey, Member States should be able to use, where necessary, any additional evidence to establish to what extent adequate broadband internet access and voice communications services are available at a fixed location. That additional evidence could include data available to the national regulatory authorities through the market analysis procedure and data collected from users. Member States should be able to restrict universal service obligations in support of availability of adequate broadband internet access services to the end-user’s primary location or residence. There should be no constraints on the technical means by which the adequate broadband internet access and voice communications services at a fixed location are provided, allowing for wired or wireless technologies, nor any constraints on which undertakings provide part or all of universal service obligations. (231) In accordance with the principle of subsidiarity, it is for the Member States to decide on the basis of objective criteria which undertakings are designated as universal service providers, where appropriate taking into account the ability and the willingness of undertakings to accept all or part of the universal service obligations. This does not preclude Member States from including, in the designation process, specific conditions justified on grounds of efficiency, including grouping geographical areas or components or setting minimum periods for the designation. (232) The costs of ensuring the availability of a connection capable of delivering an adequate broadband internet access service as identified in accordance with this Directive and voice communications services at a fixed location at an affordable price within the universal service obligations should be estimated, in particular by assessing the expected financial burden for providers and users in the electronic communications sector. (233) A priori, requirements to ensure nation-wide territorial coverage imposed in the designation procedure are likely to exclude or dissuade certain undertakings from applying for being designated as universal service providers. Designating providers with universal service obligations for an excessive or indefinite period might also lead to an a priori exclusion of certain providers. Where a Member State decides to designate one or more providers for affordability purposes, it should be possible for those providers to be different from those designated for the availability element of universal service. (234) When a provider that is, on an exceptional basis, designated to provide tariff options or packages different from those provided under normal commercial conditions, as identified in accordance with this Directive or to ensure the availability at a fixed location of an adequate broadband internet access service or voice communications services, as identified in accordance with this Directive, chooses to dispose of a substantial part, viewed in light of its universal service obligations, or all, of its local access network assets in the national territory to a separate legal entity under different ultimate ownership, the competent authority should assess the effects of the transaction in order to ensure the continuity of universal service obligations in all or parts of the national territory. To that end, the competent authority which imposed the universal service obligations should be informed by the provider in advance of the disposal. The assessment of the competent authority should not prejudice the completion of the transaction. (235) In order to provide stability and support a gradual transition, Member States should be able to continue to ensure the provision of universal service in their territory, other than adequate broadband internet access and voice communications services at a fixed location, that are included in the scope of their universal service obligations on the basis of Directive 2002/22/EC on the date of entry into force of this Directive, provided the services or comparable services are not available under normal commercial circumstances. Allowing the continuation of the provision of public payphones to the general public by use of coins, credit or debit cards, or pre-payment cards, including cards for use with dialling codes, directories and directory enquiry services under the universal service regime, for as long as the need is demonstrated, would give Member States the flexibility necessary to duly take into account the varying national circumstances. This can include providing public pay telephones in the main entry points of the country, such as airports or train and bus stations, as well as places used by people in the case of an emergency, such as hospitals, police stations and highway emergency areas, to meet the reasonable needs of end-users, including in particular end-users with disabilities. (236) Member States should monitor the situation of consumers with respect to their use of adequate broadband internet access and voice communications services and in particular with respect to affordability. The affordability of adequate broadband internet access and voice communications services is related to the information which users receive regarding usage expenses as well as the relative cost of usage compared to other services, and is also related to their ability to control expenditure. Affordability therefore means giving power to consumers through obligations imposed on providers. Those obligations include a specified level of itemised billing, the possibility for consumers selectively to block certain calls, such as high-priced calls to premium services, to control expenditure via pre-payment means, and to offset up-front connection fees. Such measures may need to be reviewed and changed in light of market developments. Itemised bills on the usage of internet access should indicate only the time, duration and amount of consumption during a usage session but not indicate the websites or internet end-points connected to during such a usage session. (237) Except in cases of persistent late payment or non-payment of bills, consumers entitled to affordable tariffs should, pending resolution of the dispute, be protected from immediate disconnection from the network on the grounds of an unpaid bill and, in particular, in the case of disputes over high bills for premium-rate services, continue to have access to essential voice communications services and a minimum service level of internet access as defined by Member States. It should be possible for Member States to decide that such access is to continue to be provided only if the subscriber continues to pay line rental or basic internet access charges. (238) Where the provision of adequate broadband internet access and voice communications services or the provision of other services in accordance with this Directive result in an unfair burden on a provider, taking due account of the costs and revenues as well as the intangible benefits resulting from the provision of the services concerned, that unfair burden can be included in any net cost calculation of universal service obligations. (239) Member States should, where necessary, establish mechanisms for financing the net cost of universal service obligations where it is demonstrated that the obligations can only be provided at a loss or at a net cost which falls outside normal commercial standards. It is important to ensure that the net cost of universal service obligations is properly calculated and that any financing is undertaken with minimum distortion to the market and to undertakings, and is compatible with Articles 107 and 108 TFEU. (240) Any calculation of the net cost of universal service obligations should take due account of costs and revenues, as well as the intangible benefits resulting from providing universal service, but should not hinder the general aim of ensuring that pricing structures reflect costs. Any net costs of universal service obligations should be calculated on the basis of transparent procedures. (241) Taking into account intangible benefits means that an estimate in monetary terms, of the indirect benefits that an undertaking derives by virtue of its position as universal service provider, should be deducted from the direct net cost of universal service obligations in order to determine the overall cost burden. (242) When a universal service obligation represents an unfair burden on a provider, it is appropriate to allow Member States to establish mechanisms for efficiently recovering net costs. Recovery via public funds constitutes one method of recovering the net costs of universal service obligations. Sharing the net costs of universal service obligations between providers of electronic communications networks and services is another method. Member States should be able to finance the net costs of different elements of universal service through different mechanisms, or to finance the net costs of some or all elements from either of the mechanisms or a combination of both. Adequate broadband internet access brings benefits not only to the electronic communications sector but also to the wider online economy and to society as a whole. Providing a connection which supports broadband speeds to an increased number of end-users enables them to use online services and so actively to participate in the digital society. Ensuring such connections on the basis of universal service obligations serves both the public interest and the interests of electronic communications providers. Those facts should be taken into account by Member States when choosing and designing mechanisms for recovering net costs. (243) In the case of cost recovery by means of sharing the net cost of universal service obligations between providers of electronic communications networks and services, Member States should ensure that the method of allocation amongst providers is based on objective and non-discriminatory criteria and is in accordance with the principle of proportionality. This principle does not prevent Member States from exempting new entrants which have not achieved any significant market presence. Any funding mechanism should ensure that market participants only contribute to the financing of universal service obligations and not to other activities which are not directly linked to the provision of the universal service obligations. Recovery mechanisms should respect the principles of Union law, and in particular in the case of sharing mechanisms those of non-discrimination and proportionality. Any funding mechanism should ensure that users in one Member State do not contribute to the costs of providing universal service in another Member State. It should be possible to share the net cost of universal service obligations between all or certain specified classes of providers. Member States should ensure that the sharing mechanism respects the principles of transparency, least market distortion, non-discrimination and proportionality. Least market distortion means that contributions should be recovered in a way that as far as possible minimises the impact of the financial burden falling on end-users, for example by spreading contributions as widely as possible. (244) Providers benefiting from universal service funding should provide national regulatory authorities with a sufficient level of detail of the specific elements requiring such funding in order to justify their request. Member States’ schemes for the costing and financing of universal service obligations should be communicated to the Commission for verification of compatibility with the TFEU. Member States should ensure effective transparency and control of amounts charged to finance universal service obligations. Calculation of the net costs of providing universal service should be based on an objective and transparent methodology to ensure the most cost-effective provision of universal service and promote a level playing field for market participants. Making the methodology intended to be used to calculate the net costs of individual universal service elements known in advance before implementing the calculation could help to achieve increased transparency. (245) Member States are not permitted to impose on market participants financial contributions which relate to measures which are not part of the universal service obligations. Individual Member States remain free to impose special measures (outside the scope of universal service obligations) and finance them in accordance with Union law but not by means of contributions from market participants. (246) In order to effectively support the free movement of goods, services and persons within the Union, it should be possible to use certain national numbering resources, in particular certain non-geographic numbers, in an extraterritorial manner, that is to say outside the territory of the assigning Member State. In light of the considerable risk of fraud with respect to interpersonal communications, such extraterritorial use should be allowed only for the provision of electronic communications services other than interpersonal communications services. Enforcement of relevant national laws, in particular consumer protection rules and other rules related to the use of numbering resources should be ensured by Member States independently of where the rights of use have been granted and where the numbering resources are used within the Union. Member States remain competent to apply their national law to numbering resources used in their territory, including where rights have been granted in another Member State. (247) The national regulatory or other competent authorities of the Member States where numbering resources from another Member State are used, do not have control over those numbering resources. It is therefore essential that the national regulatory or other competent authority of the Member State which grants the rights of extraterritorial use should also ensure the effective protection of the end-users in the Member States where those numbers are used. In order to achieve effective protection, national regulatory or other competent authority granting rights of extraterritorial use should attach conditions in accordance with this Directive regarding the respect by the provider of consumer protection rules and other rules related to the use of numbering resources in those Member States where those resources will be used. (248) The national regulatory or other competent authorities of those Member States where numbering resources are used should be able to request the support of the national regulatory or other competent authorities that granted the rights of use for the numbering resources to assist in enforcing its rules. Enforcement measures by the national regulatory or other competent authorities that granted the rights of use should include dissuasive penalties, in particular in the case of a serious breach the withdrawal of the right of extraterritorial use for the numbering resources assigned to the undertaking concerned. The requirements on extraterritorial use should be without prejudice to Member States’ powers to block, on a case-by-case basis, access to numbers or services where that is justified by reasons of fraud or misuse. The extraterritorial use of numbering resources should be without prejudice to Union rules related to the provision of roaming services, including those relative to preventing anomalous or abusive use of roaming services which are subject to retail price regulation and which benefit from regulated wholesale roaming rates. Member States should continue to be able to enter into specific agreements on extraterritorial use of numbering resources with third countries. (249) Member States should promote over-the-air provisioning of numbering resources to facilitate switching of electronic communications providers. Over-the-air provisioning of numbering resources enables the reprogramming of communications equipment identifiers without physical access to the devices concerned. This feature is particularly relevant for machine-to-machine services, that is to say services involving an automated transfer of data and information between devices or software-based applications with limited or no human interaction. Providers of such machine-to-machine services might not have recourse to physical access to their devices due to their use in remote conditions, or to the large number of devices deployed or to their usage patterns. In light of the emerging machine-to-machine market and new technologies, Member States should strive to ensure technology neutrality in promoting over-the-air provisioning. (250) Access to numbering resources on the basis of transparent, objective and non-discriminatory criteria is essential for undertakings to compete in the electronic communications sector. Member States should be able to grant rights of use for numbering resources to undertakings other than providers of electronic communications networks or services in light of the increasing relevance of numbers for various Internet of Things services. All elements of national numbering plans should be managed by national regulatory or other competent authorities, including point codes used in network addressing. Where there is a need for harmonisation of numbering resources in the Union to support the development of pan-European services or cross-border services, in particular new machine-to-machine-based services such as connected cars, and where the demand could not be met on the basis of the existing numbering resources in place, the Commission can take implementing measures with the assistance of BEREC. (251) It should be possible to fulfil the requirement to publish decisions on the granting of rights of use for numbering resources by making those decisions publicly accessible via a website. (252) Considering the particular aspects related to the reporting of missing children, Member States should maintain their commitment to ensure that a well-functioning service for reporting missing children is actually available in their territories under the number ‘116000’. Member States should take appropriate measures to ensure that a sufficient level of service quality in operating the ‘116000’ number is achieved. (253) In parallel with the missing children hotline number ‘116000’, many Member States also ensure that children have access to a child-friendly service operating a helpline that helps children in need of care and protection through the use of the ‘116111’ number. Such Member States and the Commission should ensure that awareness is raised among citizens, and in particular among children and among national child protection systems, about the existence of the ‘116111’ helpline. (254) An internal market implies that end-users are able to access all numbers included in the national numbering plans of other Member States and to access services using non-geographic numbers, including freephone and premium-rate numbers, within the Union, except where the called end-user has chosen, for commercial reasons, to limit access from certain geographical areas. End-users should also be able to access numbers from the Universal International Freephone Numbers (UIFN). Cross-border access to numbering resources and associated services should not be prevented, except in objectively justified cases, for example to combat fraud or abuse (for example, in connection with certain premium-rate services), when the number is defined as having a national scope only (for example, a national short code) or when it is economically unfeasible. Tariffs charged to parties calling from outside the Member State concerned need not be the same as for those parties calling from inside that Member State. Users should be fully informed in advance and in a clear manner of any charges applicable to freephone numbers, such as international call charges for numbers accessible through standard international dialling codes. Where interconnection or other service revenues are withheld by providers of electronic communications services for reasons of fraud or misuse, Member States should ensure that retained service revenues are refunded to the end-users affected by the relevant fraud or misuse where possible. (255) In accordance with the principle of proportionality, a number of provisions on end-user rights in this Directive should not apply to microenterprises which provide only number-independent interpersonal communications services. According to the case law of the Court of Justice, the definition of small and medium-sized enterprises, which includes microenterprises, is to be interpreted strictly. In order to include only enterprises that are genuinely independent microenterprises, it is necessary to examine the structure of microenterprises which form an economic group, the power of which exceeds the power of a microenterprise, and to ensure that the definition of microenterprise is not circumvented by purely formal means. (256) The completion of the single market for electronic communications requires the removal of barriers for end-users to have cross-border access to electronic communications services across the Union. Providers of electronic communications to the public should not deny or restrict access or discriminate against end-users on the basis of their nationality, or Member State of residence or of establishment. Differentiation should, however, be possible on the basis of objectively justifiable differences in costs and risks, not limited to the measures provided for in Regulation (EU) No 531/2012 in respect of abusive or anomalous use of regulated retail roaming services. (257) Divergent implementation of the rules on end-user protection has created significant internal market barriers affecting both providers of electronic communications services and end-users. Those barriers should be reduced by the applicability of the same rules ensuring a high common level of protection across the Union. A calibrated full harmonisation of the end-user rights covered by this Directive should considerably increase legal certainty for both end-users and providers of electronic communications services, and should significantly lower entry barriers and unnecessary compliance burden stemming from the fragmentation of the rules. Full harmonisation helps to overcome barriers to the functioning of the internal market resulting from such national provisions concerning end-user rights which at the same time protect national providers against competition from other Member States. In order to achieve a high common level of protection, several provisions concerning end-user rights should be reasonably enhanced in this Directive in light of best practices in Member States. Full harmonisation of their rights increases the trust of end-users in the internal market as they benefit from an equally high level of protection when using electronic communications services, not only in their Member State but also while living, working or travelling in other Member States. Full harmonisation should extend only to the subject matters covered by the provisions on end-user rights in this Directive. Therefore, it should not affect national law with respect to those aspects of end-user protection, including some aspects of transparency measures which are not covered by those provisions. For example, measures relating to transparency obligations which are not covered by this Directive should be considered to be compatible with the principle of full harmonisation whereas additional requirements regarding transparency issues covered by this Directive, such as publication of information, should be considered to be incompatible. Moreover, Member States should be able to maintain or introduce national provisions on issues not specifically addressed in this Directive, in particular in order to address newly emerging issues. (258) Contracts are an important tool for end- users to ensure transparency of information and legal certainty. Most service providers in a competitive environment will conclude contracts with their customers for reasons of commercial desirability. In addition to this Directive, the requirements of existing Union consumer protection law relating to contracts, in particular Council Directive 93/13/EEC (37) and Directive 2011/83/EU of the European Parliament and of the Council (38), apply to consumer transactions relating to electronic communications networks and services. The inclusion of information requirements in this Directive, which might also be required pursuant to Directive 2011/83/EU, should not lead to duplication of the information within pre-contractual and contractual documents. Relevant information provided in respect of this Directive, including any more prescriptive and more detailed informational requirements, should be considered to fulfil the corresponding requirements pursuant to Directive 2011/83/EU. (259) Some of those end-user protection provisions which a priori apply only to consumers, namely those on contract information, maximum contract duration and bundles, should benefit not only consumers, but also microenterprises and small enterprises, and not-for-profit organisations as defined in national law. The bargaining position of those categories of enterprises and organisations is comparable to that of consumers and they should therefore benefit from the same level of protection unless they explicitly waive those rights. Obligations on contract information in this Directive, including those of Directive 2011/83/EU that are referred to in this Directive, should apply irrespective of whether any payment is made and of the amount of the payment to be made by the customer. The obligations on contract information, including those contained in Directive 2011/83/EU, should apply automatically to microenterprises, small enterprises and not-for-profit organisations unless they prefer negotiating individualised contract terms with providers of electronic communications services. As opposed to microenterprises, small enterprises and not-for-profit organisations, larger enterprises usually have stronger bargaining power and do, therefore, not depend on the same contractual information requirements as consumers. Other provisions, such as number portability, which are important also for larger enterprises should continue to apply to all end-users. Not-for-profit organisations are legal entities that do not earn a profit for their owners or members. Typically, not-for-profit organisations are charities or other types of public interest organisations. Hence, in light of the comparable situation, it is legitimate to treat such organisations in the same way as microenterprises or small enterprises under this Directive, insofar as end-user rights are concerned. (260) The specificities of the electronic communications sector require, beyond horizontal contract rules, a limited number of additional end-user protection provisions. End-users should be informed, inter alia, of any quality of service levels offered, conditions for promotions and termination of contracts, applicable tariff plans and tariffs for services subject to particular pricing conditions. That information is relevant for providers of publicly available electronic communications services other than transmission services used for the provision of machine-to-machine services. Without prejudice to the applicable rules on the protection of personal data, a provider of publicly available electronic communications services should not be subject to the obligations on information requirements for contracts where that provider, and affiliated companies or persons, do not receive any remuneration directly or indirectly linked to the provision of electronic communications services, such as where a university gives visitors free access to its Wi-Fi network on campus without receiving any remuneration, whether through payment from the users or through advertising revenues. (261) In order to enable the end-user to make a well-informed choice, it is essential that the required relevant information is provided prior to the conclusion of the contract and in clear and understandable language and on a durable medium or, where not feasible and without prejudice to the definition of durable medium set out in Directive 2011/83/EU, in a document, made available by the provider and notified to the user, that is easy to download, open and consult on devices commonly used by consumers. In order to facilitate choice, providers should also present a summary of the essential contract terms. In order to facilitate comparability and reduce compliance cost, the Commission should, after consulting BEREC, adopt a template for such contract summaries. The pre-contractually provided information as well as the summary template should constitute an integral part of the final contract. The contract summary should be concise and easily readable, ideally no longer than the equivalent of one single-sided A4 page or, where a number of different services are bundled into a single contract, the equivalent of up to three single-sided A4 pages. (262) Following the adoption of Regulation (EU) 2015/2120, the provisions in this Directive regarding information on conditions limiting access to, or the use of, services and applications as well as information on traffic shaping became obsolete and should be repealed. (263) With respect to terminal equipment, the customer contract should specify any conditions imposed by the provider on the use of the equipment, such as by way of ‘SIM-locking’ mobile devices, if such conditions are not prohibited under national law, and any charges due on termination of the contract, whether before or on the agreed expiry date, including any cost imposed in order to retain the equipment. Where the end-user chooses to retain terminal equipment bundled at the moment of the contract conclusion, any compensation due should not exceed its pro rata temporis value calculated on the basis of the value at the moment of the contract conclusion, or on the remaining part of the service fee until the end of the contract, whichever amount is smaller. Member States should be able to choose other methods of calculating the compensation rate, where such a rate is equal to or less than that compensation calculated. Any restriction to the usage of terminal equipment on other networks should be lifted, free of charge, by the provider at the latest upon payment of such compensation. (264) Without prejudice to the substantive obligation on the provider related to security by virtue of this Directive, the contract should specify the type of action the provider might take in the case of security incidents, threats or vulnerabilities. In addition, the contract should also specify any compensation and refund arrangements available if a provider responds inadequately to a security incident, including if a security incident, notified to the provider, takes place due to known software or hardware vulnerabilities, for which patches have been issued by the manufacturer or developer and the service provider has not applied those patches or taken any other appropriate counter-measure. (265) The availability of transparent, up-to-date and comparable information on offers and services is a key element for consumers in competitive markets where several providers offer services. End-users should be able to compare the prices of various services offered on the market easily on the basis of information published in an easily accessible form. In order to allow them to make price and service comparisons easily, competent authorities in coordination, where relevant, with national regulatory authorities should be able to require from providers of internet access services or publicly available interpersonal communication services greater transparency as regards information, including tariffs, quality of service, conditions on terminal equipment supplied, and other relevant statistics. Any such requirements should take due account of the characteristics of those networks or services. They should also ensure that third parties have the right to use, without charge, publicly available information published by such undertakings, with a view to providing comparison tools. (266) End-users are often not aware of the cost of their consumption behaviour or have difficulties in estimating their time or data consumption when using electronic communications services. In order to increase transparency and to allow for better control of their communications budget, it is important to provide end-users with facilities that enable them to track their consumption in a timely manner. In addition, Member States should be able to maintain or introduce provisions on consumption limits protecting end-users against ‘bill-shocks’, including in relation to premium rate services and other services subject to particular pricing conditions. This allows competent authorities to require information about such prices to be provided prior to providing the service and does not prejudice the possibility of Member States to maintain or introduce general obligations for premium rate services to ensure the effective protection of end-users. (267) Independent comparison tools, such as websites, are an effective means for end-users to assess the merits of different providers of internet access services and interpersonal communications services, where provided against recurring or consumption-based direct monetary payments, and to obtain impartial information, in particular by comparing prices, tariffs, and quality parameters in one place. Such tools should be operationally independent from service providers and no service provider should be given favourable treatment in search results. Such tools should aim to provide information that is both clear and concise, and complete and comprehensive. They should also aim to include the broadest possible range of offers, in order to give a representative overview and cover a significant part of the market. The information given on such tools should be trustworthy, impartial and transparent. End-users should be informed of the availability of such tools. Member States should ensure that end-users have free access to at least one such tool in their respective territories. Where there is only one tool in a Member State and that tool ceases to operate or ceases to comply with the quality criteria, the Member State should ensure that end-users have access within a reasonable time to another comparison tool at national level. (268) Independent comparison tools can be operated by private undertakings, or by or on behalf of competent authorities, however they should be operated in accordance with specified quality criteria including the requirement to provide details of their owners, provide accurate and up-to-date information, state the time of the last update, set out clear, objective criteria on which the comparison will be based, and include a broad range of offers covering a significant part of the market. Member States should be able to determine how often comparison tools are required to review and update the information they provide to end-users, taking into account the frequency with which providers of internet access services and of publicly available interpersonal communications services, generally update their tariff and quality information. (269) In order to address public interest issues with respect to the use of internet access services and publicly available number-based interpersonal communications services and to encourage protection of the rights and freedoms of others, Member States should be able to produce and disseminate or have disseminated, with the aid of providers of such services, public-interest information related to the use of such services. It should be possible for such information to include public-interest information regarding the most common infringements and their legal consequences, for instance regarding copyright infringement, other unlawful uses and the dissemination of harmful content, and advice and means of protection against risks to personal security, for example those arising from disclosure of personal information in certain circumstances, as well as risks to privacy and personal data, and the availability of easy-to-use and configurable software or software options allowing protection for children or vulnerable persons. The information could be coordinated by way of the cooperation procedure established in this Directive. Such public-interest information should be updated where necessary and should be presented in easily comprehensible formats, as determined by each Member State, and on national public authority websites. Member States should be able to oblige providers of internet access services and publicly available number-based interpersonal communications services to disseminate this standardised information to all of their customers in a manner considered to be appropriate by the national public authorities. Dissemination of such information should, however, not impose an excessive burden on providers. If it does so, Member States should require such dissemination by the means used by providers in communications with end-users made in the ordinary course of business. (270) In the absence of relevant rules of Union law, content, applications and services are considered to be lawful or harmful in accordance with national substantive and procedural law. It is a task for the Member States, not for providers of electronic communications networks or services, to decide, in accordance with due process, whether content, applications or services are lawful or harmful. This Directive and Directive 2002/58/EC are without prejudice to Directive 2000/31/EC, which, inter alia, contains a ‘mere conduit’ rule for intermediary service providers, as defined therein. (271) National regulatory authorities in coordination with other competent authorities, or where relevant, other competent authorities in co-ordination with national regulatory authorities should be empowered to monitor the quality of services and to collect systematically information on the quality of services offered by providers of internet access services and of publicly available interpersonal communications services, to the extent that the latter are able to offer minimum levels of service quality either through control of at least some elements of the network or by virtue of a service level agreement to that end, including the quality related to the provision of services to end-users with disabilities. That information should be collected on the basis of criteria which allow comparability between service providers and between Member States. Providers of such electronic communications services, operating in a competitive environment, are likely to make adequate and up-to-date information on their services publicly available for reasons of commercial advantage. National regulatory authorities in coordination with other competent authorities, or where relevant, other competent authorities in co-ordination with national regulatory authorities should nonetheless be able to require publication of such information where it is demonstrated that such information is not effectively available to the public. Where the quality of services of publicly available interpersonal communication services depends on any external factors, such as control of signal transmission or network connectivity, national regulatory authorities in coordination with other competent authorities should be able to require providers of such services to inform their consumers accordingly. (272) National regulatory authorities in coordination with other competent authorities should also set out the measurement methods to be applied by the service providers in order to improve the comparability of the data provided. In order to facilitate comparability across the Union and to reduce compliance cost, BEREC should adopt guidelines on relevant quality of service parameters which national regulatory authorities in coordination with other competent authorities should take into utmost account. (273) In order to take full advantage of the competitive environment, consumers should be able to make informed choices and to change providers when it is in their best interest to do so. It is essential to ensure that they are able to do so without being hindered by legal, technical or practical obstacles, including contractual conditions, procedures and charges. That does not preclude providers from setting reasonable minimum contractual periods of up to 24 months in consumer contracts. However, Member States should have the possibility to maintain or introduce provisions for a shorter maximum duration and to permit consumers to change tariff plans or terminate the contract within the contract period without incurring additional costs in light of national conditions, such as levels of competition and stability of network investments. Independently from the electronic communications service contract, consumers might prefer and benefit from a longer reimbursement period for physical connections. Such consumer commitments can be an important factor in facilitating deployment of very high capacity networks up to or very close to end-user premises, including through demand aggregation schemes which enable network investors to reduce initial take-up risks. However, the rights of consumers to switch between providers of electronic communications services, as established in this Directive, should not be restricted by such reimbursement periods in contracts on physical connections and such contracts should not cover terminal or internet access equipment, such as handsets, routers or modems. Member States should ensure the equal treatment of entities, including operators, financing the deployment of a very high capacity physical connection to the premises of an end-user, including where such financing is by way of an instalment contract. (274) Automatic prolongation of contracts for electronic communications services is also possible. In those cases, end-users should be able to terminate their contract without incurring any costs after the expiry of the contract term. (275) Any changes to the contractual conditions proposed by providers of publicly available electronic communications services other than number-independent interpersonal communications services, which are not to the benefit of the end-user, for example in relation to charges, tariffs, data volume limitations, data speeds, coverage, or the processing of personal data, should give rise to the right of the end-user to terminate the contract without incurring any costs, even if they are combined with some beneficial changes. Any change to the contractual conditions by the provider should therefore entitle the end-user to terminate the contract unless each change is in itself beneficial to the end-user, or the changes are of a purely administrative nature, such as a change in the provider’s address, and have no negative effect on the end-user, or the changes are strictly imposed by legislative or regulatory changes, such as new contract information requirements imposed by Union or national law. Whether a change is exclusively to the benefit of the end-user should be assessed on the basis of objective criteria. The end-user’s right to terminate the contract should be excluded only if the provider is able to demonstrate that all contract changes are exclusively to the benefit of the end-user or are of a purely administrative nature without any negative effect on the end-user. (276) End-users should be notified of any changes to the contractual conditions by means of a durable medium. End-users other than consumers, microenterprises or small enterprises, or not-for-profit organisations should not benefit from the termination rights in the case of contract modification, insofar as transmission services used for machine-to-machine services are concerned. Member States should be able to provide for specific end-user protections regarding contract termination where the end-users change their place of residence. The provisions on contract termination should be without prejudice to other provisions of Union or national law concerning the grounds on which contracts can be terminated or on which contractual terms and conditions can be changed by the service provider or by the end-user. (277) The possibility of switching between providers is key for effective competition in a competitive environment. The availability of transparent, accurate and timely information on switching should increase the end-users’ confidence in switching and make them more willing to engage actively in the competitive process. Service providers should ensure continuity of service so that end-users are able to switch providers without being hindered by the risk of a loss of service and, where technically possible, allow for switching on the date requested by end-users. (278) Number portability is a key facilitator of consumer choice and effective competition in competitive electronic communications markets. End-users who so request should be able to retain their numbers independently of the provider of service and for a limited time between the switching of providers of service. The provision of this facility between connections to the public telephone network at fixed and non-fixed locations is not covered by this Directive. However, Member States should be able to apply provisions for porting numbers between networks providing services at a fixed location and mobile networks. (279) The impact of number portability is considerably strengthened when there is transparent tariff information, both for end-users who port their numbers and for end-users who call those who have ported their numbers. National regulatory authorities should, where feasible, facilitate appropriate tariff transparency as part of the implementation of number portability. (280) When ensuring that pricing for interconnection related to the provision of number portability is cost-oriented, national regulatory authorities should also be able to take account of prices available in comparable markets. (281) Number portability is a key facilitator of consumer choice and effective competition in competitive markets for electronic communications and should be implemented with the minimum delay, so that the number is functionally activated within one working day and the end-user does not experience a loss of service lasting longer than one working day from the agreed date. The right to port the number should be attributed to the end-user who has the relevant (pre- or post-paid) contract with the provider. In order to facilitate a one-stop-shop enabling a seamless switching experience for end- users, the switching process should be led by the receiving provider of electronic communications to the public. National regulatory or, where relevant, other competent authorities should be able to prescribe the global process of the switching and of the porting of numbers, taking into account national provisions on contracts and technological developments. This should include, where available, a requirement for the porting to be completed though over-the-air provisioning, unless an end-user requests otherwise. Experience in certain Member States has shown that there is a risk of end-users being switched to another provider without having given their consent. While that is a matter that should primarily be addressed by law enforcement authorities, Member States should be able to impose such minimum proportionate measures regarding the switching process, including appropriate penalties, as are necessary to minimise such risks, and to ensure that end-users are protected throughout the switching process without making the process less attractive for them. The right to port numbers should not be restricted by contractual conditions. (282) In order to ensure that switching and porting take place within the time-limits provided for in this Directive, Member States should provide for the compensation of end-users by providers in an easy and timely manner where an agreement between a provider and an end-user is not respected. Such measures should be proportionate to the length of the delay in complying with the agreement. End-users should at least be compensated for delays exceeding one working day in activation of service, porting of a number, or loss of service, and where providers miss agreed service or installation appointments. Additional compensation could also be in the form of an automatic reduction of the remuneration where the transferring provider is to continue providing its services until the services of the receiving provider are activated. (283) Bundles comprising at least either an internet access service or a publicly available number-based interpersonal communications service, as well as other services, such as publicly available number-independent interpersonal communications services, linear broadcasting and machine-to-machine services, or terminal equipment, have become increasingly widespread and are an important element of competition. For the purposes of this Directive, a bundle should be considered to exist in situations where the elements of the bundle are provided or sold by the same provider under the same or a closely related or linked contract. While bundles often bring about benefits for consumers, they can make switching more difficult or costly and raise risks of contractual ‘lock-in’. Where different services and terminal equipment within a bundle are subject to divergent rules on contract termination and switching or on contractual commitments regarding the acquisition of terminal equipment, consumers are effectively hampered in their rights under this Directive to switch to competitive offers for the entire bundle or parts of it. Certain essential provisions of this Directive regarding contract summary information, transparency, contract duration and termination and switching should, therefore, apply to all elements of a bundle, including terminal equipment, other services such as digital content or digital services, and electronic communications services which are not directly covered by the scope of those provisions. All end-user obligations applicable under this Directive to a given electronic communications service when provided or sold as a stand-alone service should also be applicable when it is part of a bundle with at least an internet access service or a publicly available number-based interpersonal communications service. Other contractual issues, such as the remedies applicable in the event of non-conformity with the contract, should be governed by the rules applicable to the respective element of the bundle, for instance by the rules of contracts for the sales of goods or for the supply of digital content. However, a right to terminate any element of a bundle comprising at least an internet access service or a publicly available number-based interpersonal communications service before the end of the agreed contract term because of a lack of conformity or a failure to supply should give a consumer the right to terminate all elements of the bundle. Also, in order to maintain their capacity to switch easily providers, consumers should not be locked in with a provider by means of a contractual de facto extension of the initial contract period. (284) Providers of number-based interpersonal communications services have an obligation to provide access to emergency services through emergency communications. In exceptional circumstances, namely due to a lack of technical feasibility, they might not be able to provide access to emergency services or caller location, or to both. In such cases, they should inform their customers adequately in the contract. Such providers should provide their customers with clear and transparent information in the initial contract and update it in the event of any change in the provision of access to emergency services, for example in invoices. That information should include any limitations on territorial coverage, on the basis of the planned technical operating parameters of the communications service and the available infrastructure. Where the service is not provided over a connection which is managed to give a specified quality of service, the information should also include the level of reliability of the access and of caller location information compared to a service that is provided over such a connection, taking into account current technology and quality standards, as well as any quality of service parameters specified under this Directive. (285) End-users should be able to access emergency services through emergency communications free of charge and without having to use any means of payment, from any device which enables number-based interpersonal communications services, including when using roaming services in a Member State. Emergency communications are a means of communication that includes not only voice communications services, but also SMS, messaging, video or other types of communications, for example real time text, total conversation and relay services. Member States, taking into account the capabilities and technical equipment of the PSAPs, should be able to determine which number-based interpersonal communications services are appropriate for emergency services, including the possibility to limit those options to voice communications services and their equivalent for end-users with disabilities, or to add additional options as agreed with national PSAPs. Emergency communication can be triggered on behalf of a person by an in-vehicle emergency call or an eCall as defined in Regulation (EU) 2015/758. (286) Member States should ensure that providers of number-based interpersonal communications services provide reliable and accurate access to emergency services, taking into account national specifications and criteria and the capabilities of national PSAPs. Member States should consider the PSAP’s ability to handle emergency communications in more than one language. Where the number-based interpersonal communications service is not provided over a connection which is managed to give a specified quality of service, the service provider might not be able to ensure that emergency calls made through their service are routed to the most appropriate PSAP with the same reliability. For such network-independent providers, namely providers which are not integrated with a provider of public electronic communications networks, providing caller location information may not always be technically feasible. Member States should ensure that standards ensuring accurate and reliable routing and connection to the emergency services are implemented as soon as possible in order to allow network-independent providers of number-based interpersonal communications services to fulfil the obligations related to access to emergency services and caller location information provision at a level comparable to that required of other providers of such communications services. Where such standards and the related PSAP systems have not been implemented, network-independent number-based interpersonal communications services should not be required to provide access to emergency services except in a manner that is technically feasible or economically viable. This may, for example, include the designation by a Member State of a single, central PSAP for receiving emergency communications. Nonetheless, such providers should inform end-users when access to the single European emergency number ‘112’ or to caller location information is not supported. (287) In order to improve the reporting and performance measurement by Member States with respect to the answering and handling of emergency calls, the Commission should, every two years, report to the European Parliament and to the Council on the effectiveness of the implementation of the single European emergency number ‘112’. (288) Member States should take specific measures to ensure that emergency services, including the single European emergency number ‘112’, are equally accessible to end-users with disabilities, in particular deaf, hearing-impaired, speech-impaired and deaf-blind end-users and in accordance with Union law harmonising accessibility requirements for products and services. This could involve the provision of special terminal devices for end-users with disabilities when other ways of communication are not suitable for them. (289) It is important to increase awareness of the single European emergency number ‘112’ in order to improve the level of protection and security of citizens travelling in the Union. To that end, citizens should be made fully aware, when travelling in any Member State, in particular through information provided in international bus terminals, train stations, ports or airports and in telephone directories, end-user and billing material, that the single European emergency number ‘112’ can be used as a single emergency number throughout the Union. This is primarily the responsibility of the Member States, but the Commission should continue both to support and to supplement initiatives of the Member States to heighten awareness of the single European emergency number ‘112’ and periodically to evaluate the public’s awareness of it. (290) Caller location information, which applies to all emergency communications, improves the level of protection and the security of end-users and assists the emergency services in the discharge of their duties, provided that the transfer of emergency communication and associated data to the emergency services concerned is guaranteed by the national system of PSAPs. The reception and use of caller location information, which includes both network-based location information and where available, enhanced handset caller location information, should comply with relevant Union law on the processing of personal data and security measures. Undertakings that provide network-based location should make caller location information available to emergency services as soon as the call reaches that service, independently of the technology used. However, handset-based location technologies have proven to be significantly more accurate and cost effective due to the availability of data provided by the European Geostationary Navigation Overlay Service and Galileo Satellite system and other Global Navigation Satellite Systems and Wi-Fi data. Therefore, handset-derived caller location information should complement network-based location information even if the handset-derived location becomes available only after the emergency communication is set up. Member States should ensure that, where available, the handset-derived caller location information is made available to the most appropriate PSAP. This might not be always possible, for example when the location is not available on the handset or through the interpersonal communications service used, or when it is not technically feasible to obtain that information. Furthermore, Member States should ensure that the PSAPs are able to retrieve and manage the caller location information available, where feasible. The establishment and transmission of caller location information should be free of charge for both the end-user and the authority handling the emergency communication irrespective of the means of establishment, for example through the handset or the network, or the means of transmission, for example through voice channel, SMS or IP-based. (291) In order to respond to technological developments concerning accurate caller location information, equivalent access for end-users with disabilities and call routing to the most appropriate PSAP, the Commission should be empowered to adopt by means of a delegated act measures necessary to ensure the compatibility, interoperability, quality, reliability and continuity of emergency communications in the Union, such as functional provisions determining the role of various parties within the communications chain, for example number-based interpersonal communications service providers, network operators and PSAPs, as well as technical provisions determining the technical means to fulfil the functional provisions. Such measures should be without prejudice to the organisation of emergency services of Member States. (292) A citizen in one Member State who needs to contact the emergency services in another Member State cannot do so because the emergency services may not have any contact information for emergency services in other Member States. A Union-wide, secure database of numbers for a lead emergency service in each country should therefore be introduced. To that end, BEREC should maintain a secure database of E.164 numbers of Member State emergency service numbers, if such a database is not maintained by another organisation, in order to ensure that the emergency services in one Member State can be contacted by the emergency services in another. (293) Diverging national law has developed in relation to the transmission by electronic communications services of public warnings regarding imminent or developing major emergencies and disasters. In order to approximate law in that area, this Directive should therefore provide that, when public warning systems are in place, public warnings should be transmitted by providers of mobile number-based interpersonal communication services to all end-users concerned. The end-users concerned should be considered to be those who are located in the geographic areas potentially being affected by imminent or developing major emergencies and disasters during the warning period, as determined by the competent authorities. (294) Where the effective reach of all end-users concerned, independently of their place or Member State of residence, is ensured and fulfils the highest level of data security, Member States should be able to provide for the transmission of public warnings by publicly available electronic communications services other than mobile number-based interpersonal communications services and other than transmission services used for broadcasting or by mobile application transmitted via internet access services. In order to inform end-users entering a Member State of the existence of such a public warning system, that Member State should ensure that those end-users receive, automatically by means of SMS, without undue delay and free of charge, easily understandable information on how to receive public warnings, including by means of mobile terminal equipment not enabled for internet access services. Public warnings other than those relying on mobile number-based interpersonal communications services should be transmitted to end-users in an easily receivable manner. Where a public warning system relies on an application, it should not require end-users to log in or register with the authorities or the application provider. End-users’ location data should be used in accordance with Directive 2002/58/EC. The transmission of public warnings should be free of charge for end-users. In its review of the implementation of this Directive, the Commission could also assess whether it is possible in accordance with Union law, and feasible to set up a single Union-wide public warning system in order to alert the public in the event of an imminent or developing disaster or major state of emergency across different Member States. (295) Member States should be able to determine if proposals for alternative systems, other than through mobile number-based interpersonal communication services, are truly equivalent to such services, taking utmost account of the corresponding BEREC guidelines. Such guidelines should be developed after consulting national authorities in charge of PSAPs in order to ensure that emergency experts have a role in their development and that there is a common understanding between different Member State authorities as to what is needed to ensure full implementation of such public warning systems within the Member States while ensuring that the citizens of the Union are effectively protected while travelling in another Member State. (296) In line with the objectives of the Charter and the obligations enshrined in the United Nations Convention on the Rights of Persons with Disabilities, the regulatory framework should ensure that all end-users, including end-users with disabilities, older people, and users with special social needs, have easy and equivalent access to affordable high quality services regardless of their place of residence within the Union. Declaration 22 annexed to the final Act of Amsterdam provides that the institutions of the Union are to take account of the needs of persons with disabilities in drawing up measures under Article 114 TFEU. (297) In order to ensure that end-users with disabilities benefit from competition and the choice of service providers enjoyed by the majority of end-users, competent authorities should specify, where appropriate and in light of national conditions, and after consulting end-users with disabilities, consumer protection requirements for end-users with disabilities to be met by providers of publicly available electronic communications services. Such requirements can include, in particular, that providers ensure that end-users with disabilities take advantage of their services on equivalent terms and conditions, including prices, tariffs and quality, as those offered to their other end-users, irrespective of any additional costs incurred by those providers. Other requirements can relate to wholesale arrangements between providers. In order to avoid creating an excessive burden on service providers competent authorities should verify, whether the objectives of equivalent access and choice can be achieved without such measures. (298) In addition to Union law harmonising accessibility requirements for products and services, this Directive sets out new enhanced affordability and availability requirements on related terminal equipment and specific equipment and specific services for end-users with disabilities. Therefore, the corresponding obligation in Directive 2002/22/EC that required Member States to encourage the availability of terminal equipment for end-users with disabilities has become obsolete and should be repealed. (299) Effective competition has developed in the provision of directory enquiry services and directories pursuant, inter alia, to Article 5 of Commission Directive 2002/77/EC (39). In order to maintain that effective competition, all providers of number-based interpersonal communications services which attribute numbers from a numbering plan to their end-users should continue to be obliged to make relevant information available in a fair, cost-oriented and non-discriminatory manner. (300) End-users should be informed about their right to determine whether they want to be included in a directory. Providers of number-based interpersonal communications services should respect the end-users’ decision when making data available to directory service providers. Article 12 of Directive 2002/58/EC ensures the end-users’ right to privacy with regard to the inclusion of their personal information in a public directory. (301) Measures at wholesale level ensuring the inclusion of end-user data in databases should comply with the safeguards for the protection of personal data under Regulation (EU) 2016/679 and Article 12 of Directive 2002/58/EC. The cost-oriented supply of that data to service providers, with the possibility for Member States to establish a centralised mechanism for providing comprehensive aggregated information to directory providers, and the provision of network access under reasonable and transparent conditions, should be put in place in order to ensure that end-users benefit fully from competition, which has largely allowed the enabling of the removal of retail regulation from these services and the provision of offers of directory services under reasonable and transparent conditions. (302) Following the abolition of the universal service obligation for directory services and given the existence of a functioning market for such services, the right to access directory enquiry services is no longer necessary. However, the national regulatory authorities should still be able to impose obligations and conditions on undertakings that control access to end-users in order to maintain access and competition in that market. (303) End-users should be able to enjoy a guarantee of interoperability in respect of all equipment sold in the Union for the reception of radio in new vehicles of category M and of digital television. Member States should be able to require minimum harmonised standards in respect of such equipment. Such standards could be adapted from time to time in light of technological and market developments. (304) Where Member States decide to adopt measures in accordance with Directive (EU) 2015/1535 for the interoperability of consumer radio receivers, they should be capable of receiving and reproducing radio services provided via digital terrestrial radio broadcasting or via IP networks, in order to ensure that interoperability is maintained. This may also improve public safety, by enabling users to rely on a wider set of technologies for accessing and receiving emergency information in the Member States. (305) It is desirable to enable consumers to achieve the fullest connectivity possible to digital television sets. Interoperability is an evolving concept in dynamic markets. Standardisation bodies should do their utmost to ensure that appropriate standards evolve along with the technologies concerned. It is likewise important to ensure that connectors are available on digital television sets that are capable of passing all the necessary elements of a digital signal, including the audio and video streams, conditional access information, service information, API information and copy protection information. This Directive should therefore ensure that the functionality associated to or implemented in connectors is not limited by network operators, service providers or equipment manufacturers and continues to evolve in line with technological developments. For display and presentation of connected television services, the realisation of a common standard through a market-driven mechanism is recognised as a consumer benefit. Member States and the Commission should be able to take policy initiatives, consistent with the Treaties, to encourage this development. (306) The provisions on interoperability of consumer radio and television equipment do not prevent car radio receivers in new vehicles of category M from being capable of receiving and reproducing radio services provided via analogue terrestrial radio broadcasting and those provisions do not prevent Member States from imposing obligations to ensure that digital radio receivers are capable of receiving and reproducing analogue terrestrial radio broadcasts. (307) Without prejudice to Union law, this Directive does not prevent Member States from adopting technical regulations related to digital terrestrial television equipment, to prepare the migration of consumers to new terrestrial broadcasting standards, and avoid the supply of equipment that would not be compliant with the standards to be rolled out. (308) Member States should be able to lay down proportionate ‘must carry’ obligations on undertakings under their jurisdiction, in the interest of legitimate public policy considerations, but such obligations should only be imposed where they are necessary to meet general interest objectives clearly defined by Member States in accordance with Union law and should be proportionate and transparent. It should be possible to apply ‘must carry’ obligations to specified radio and television broadcast channels and complementary services supplied by a specified media service provider. Obligations imposed by Member States should be reasonable, that is they should be proportionate and transparent in light of clearly defined general interest objectives. Member States should provide an objective justification for the ‘must carry’ obligations that they impose in their national law in order to ensure that such obligations are transparent, proportionate and clearly defined. The obligations should be designed in a way which provides sufficient incentives for efficient investment in infrastructure. (309) ‘Must carry’ obligations should be subject to periodic review at least every five years in order to keep them up-to-date with technological and market evolution and in order to ensure that they continue to be proportionate to the objectives to be achieved. Such obligations could, where appropriate, entail a provision for proportionate remuneration which should be set out in national law. Where that is the case, national law should also determine the applicable methodology for calculating appropriate remuneration. That methodology should avoid inconsistency with access remedies that may be imposed by national regulatory authorities on providers of transmission services used for broadcasting which have been designated as having significant market power. However, where a fixed-term contract signed before 20 December 2018 provides for a different methodology, it should be possible to continue to apply that methodology for the duration of the contract. In the absence of a national provision on remuneration, providers of radio or television broadcast channels and providers of electronic communications networks used for the transmission of those radio or television broadcast channels should be able to agree contractually on a proportionate remuneration. (310) Electronic communications networks and services used for the distribution of radio or television broadcasts to the public include cable, IPTV, satellite and terrestrial broadcasting networks. They might also include other networks to the extent that a significant number of end-users use such networks as their principal means to receive radio and television broadcasts. ‘Must carry’ obligations related to analogue television broadcast transmissions should be considered only where the lack of such an obligation would cause significant disruption for a significant number of end-users or where there are no other means of transmission for specified television broadcast channels. ‘Must carry’ obligations can include the transmission of services specifically designed to enable equivalent access by end-users with disabilities. Accordingly complementary services include services designed to improve accessibility for end-users with disabilities, such as videotext, subtitling for end-users who are deaf or hard of hearing, audio description, spoken subtitles and sign language interpretation, and could include access to the related raw-data where necessary. In light of the growing provision and reception of connected television services and the continued importance of EPGs for end-user choice the transmission of programme-related data necessary to support connected television and EPG functionalities can be included in ‘must carry’ obligations. It should be possible for such programme-related data to include information about the programme content and how to access it, but not the programme content itself. (311) Calling line identification facilities are normally available on modern telephone exchanges and can therefore increasingly be provided at little or no expense. Member States are not required to impose obligations to provide these facilities when they are already available. Directive 2002/58/EC safeguards the privacy of users with regard to itemised billing, by giving them the means to protect their right to privacy when calling line identification is implemented. The development of those services on a pan-European basis would benefit consumers and is encouraged by this Directive. A common practice by providers of internet access services is to provide customers with an e-mail address using their commercial name or trade mark. In order to ensure end-users do not suffer lock-in effects related to the risk of losing access to e-mails when changing internet access services, Member States should be able to impose obligations on providers of such services, on request, either to provide access to their e-mails, or to transfer e-mails sent to the relevant e-mail account(s). The facility should be provided free of charge and for a duration that is considered to be appropriate by the national regulatory authority. (312) The publication of information by Member States will ensure that market players and potential market entrants understand their rights and obligations, and know where to find the relevant detailed information. Publication in the national gazette helps interested parties in other Member States to find the relevant information. (313) In order to ensure that the pan-European electronic communications market is effective and efficient, the Commission should monitor and publish information on charges which contribute to determining prices to end-users. (314) In order to determine the correct application of Union law, the Commission needs to know which undertakings have been designated as having significant market power and which obligations have been placed upon market players by national regulatory authorities. In addition to publication of that information at national level, it is therefore necessary for Member States to submit that information to the Commission. Where Member States are required to send information to the Commission, they should be able to do so by electronic means, subject to agreement on appropriate authentication procedures. (315) In order to take account of market, social and technological developments, including evolution of technical standards, to manage the risks posed to security of networks and services and to ensure effective access to emergency services through emergency communications, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of setting a single maximum Union-wide voice termination rate in fixed and mobile markets; adopting measures related to emergency communications in the Union; and adapting the annexes to this Directive. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (40). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (316) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission to adopt decisions to resolve cross-border harmful interference between Member States; to identify a harmonised or coordinated approach for the purpose of addressing inconsistent implementation of general regulatory approaches by national regulatory authorities on the regulation of electronic communications markets, as well as numbering, including number ranges, portability of numbers and identifiers, number and address translation systems, and access to emergency services through the single European emergency number ‘112’; to make the implementation of standards or specifications compulsory, or remove standards or specifications from the compulsory part of the list of standards; to adopt the technical and organisational measures to appropriately manage the risks posed to security of networks and services, as well as the circumstances, format and procedures applicable to notification of security incidents; to specify relevant details relating to tradable individual rights publicly available in a standardised electronic format when the rights of use for radio spectrum are created to specify the physical and technical characteristics of small-area wireless access points; to authorise or prevent a national regulatory authority from imposing on undertakings designated as having significant market power certain obligations for access or interconnection; to harmonise specific numbers or numbering ranges to address unmet cross-border or pan-European demand for numbering resources; and to specify the contract summary template to be provided to consumers. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (41). (317) Finally, the Commission should be able to adopt, as necessary, having taken utmost account of the opinion of BEREC, recommendations in relation to the identification of the relevant product and service markets, the notifications under the procedure for consolidating the internal market and the harmonised application of the provisions of the regulatory framework. (318) The Commission should review the functioning of this Directive periodically, in particular with a view to determining the need for amendments in light of changing technological or market conditions. (319) In carrying out its review of the functioning of this Directive, the Commission should assess whether, in light of developments in the market and with regard to both competition and consumer protection, there is a continued need for the provisions on sector-specific ex ante regulation or whether those provisions should be amended or repealed. As this Directive introduces novel approaches to the regulation of electronic communications sectors, such as the possibility to extend the application of symmetric obligations beyond the first concentration or distribution point and the regulatory treatment of co-investments, a particular regard should be given in assessing their functioning. (320) Future technological and market developments, in particular changes in the use of different electronic communications services and their ability to ensure effective access to emergency services, might jeopardise the achievement of the objectives of this Directive on end-users’ rights. BEREC should therefore monitor those developments in Member States and regularly publish an opinion including an assessment of the impact of such developments on the application in practice of the provisions of this Directive relating to end-users. The Commission, taking outmost account of BEREC’s opinion, should publish a report and submit a legislative proposal where it considers it to be necessary to ensure that the objectives of this Directive are achieved. (321) Directives 2002/19/EC, 2002/20/EC, 2002/21/EC, 2002/22/EC and Article 5 of Decision No 243/2012/EU should be repealed. (322) The Commission should monitor the transition from the existing framework to the new framework. (323) Since the objective of this Directive, namely achieving a harmonised and simplified framework for the regulation of electronic communications networks, electronic communications services, associated facilities and associated services, of the conditions for the authorisation of networks and services, of radio spectrum use and of numbering resources, of access to and interconnection of electronic communications networks and associated facilities and of end-user protection cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (324) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (42), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified. (325) The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive amendment as compared to the repealed Directives. The obligation to transpose the provisions which are unchanged arises under the repealed Directives. (326) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for the transposition into national law and the dates of application of the Directives set out in Annex XII, Part B, HAVE ADOPTED THIS DIRECTIVE: PART I FRAMEWORK (GENERAL RULES FOR THE ORGANISATION OF THE SECTOR) TITLE I SCOPE, AIM AND OBJECTIVES, DEFINITIONS CHAPTER I Subject matter, aim and definitions Article 1 Subject matter, scope and aims 1. This Directive establishes a harmonised framework for the regulation of electronic communications networks, electronic communications services, associated facilities and associated services, and certain aspects of terminal equipment. It lays down tasks of national regulatory authorities and, where applicable, of other competent authorities, and establishes a set of procedures to ensure the harmonised application of the regulatory framework throughout the Union. 2. The aims of this Directive are to: (a) implement an internal market in electronic communications networks and services that results in the deployment and take-up of very high capacity networks, sustainable competition, interoperability of electronic communications services, accessibility, security of networks and services and end-user benefits; and (b) ensure the provision throughout the Union of good quality, affordable, publicly available services through effective competition and choice, to deal with circumstances in which the needs of end-users, including those with disabilities in order to access the services on an equal basis with others, are not satisfactorily met by the market and to lay down the necessary end-user rights. 3. This Directive is without prejudice to: (a) obligations imposed by national law in accordance with Union law or by Union law in respect of services provided using electronic communications networks and services; (b) measures taken at Union or national level, in accordance with Union law, to pursue general interest objectives, in particular relating to the protection of personal data and privacy, content regulation and audiovisual policy; (c) actions taken by Member States for public order and public security purposes and for defence; (d) Regulations (EU) No 531/2012 and (EU) 2015/2120 and Directive 2014/53/EU. 4. The Commission, the Body of European Regulators for Electronic Communications (‘BEREC’) and the authorities concerned shall ensure compliance of their processing of personal data with Union data protection rules. Article 2 Definitions For the purposes of this Directive, the following definitions apply: (1) ‘electronic communications network’ means transmission systems, whether or not based on a permanent infrastructure or centralised administration capacity, and, where applicable, switching or routing equipment and other resources, including network elements which are not active, which permit the conveyance of signals by wire, radio, optical or other electromagnetic means, including satellite networks, fixed (circuit- and packet-switched, including internet) and mobile networks, electricity cable systems, to the extent that they are used for the purpose of transmitting signals, networks used for radio and television broadcasting, and cable television networks, irrespective of the type of information conveyed; (2) ‘very high capacity network’ means either an electronic communications network which consists wholly of optical fibre elements at least up to the distribution point at the serving location, or an electronic communications network which is capable of delivering, under usual peak-time conditions, similar network performance in terms of available downlink and uplink bandwidth, resilience, error-related parameters, and latency and its variation; network performance can be considered similar regardless of whether the end-user experience varies due to the inherently different characteristics of the medium by which the network ultimately connects with the network termination point; (3) ‘transnational markets’ means markets identified in accordance with Article 65, which cover the Union or a substantial part thereof located in more than one Member State; (4) ‘electronic communications service’ means a service normally provided for remuneration via electronic communications networks, which encompasses, with the exception of services providing, or exercising editorial control over, content transmitted using electronic communications networks and services, the following types of services: (a) ‘internet access service’ as defined in point (2) of the second paragraph of Article 2 of Regulation (EU) 2015/2120; (b) interpersonal communications service; and (c) services consisting wholly or mainly in the conveyance of signals such as transmission services used for the provision of machine-to-machine services and for broadcasting; (5) ‘interpersonal communications service’ means a service normally provided for remuneration that enables direct interpersonal and interactive exchange of information via electronic communications networks between a finite number of persons, whereby the persons initiating or participating in the communication determine its recipient(s) and does not include services which enable interpersonal and interactive communication merely as a minor ancillary feature that is intrinsically linked to another service; (6) ‘number-based interpersonal communications service’ means an interpersonal communications service which connects with publicly assigned numbering resources, namely, a number or numbers in national or international numbering plans, or which enables communication with a number or numbers in national or international numbering plans; (7) ‘number-independent interpersonal communications service’ means an interpersonal communications service which does not connect with publicly assigned numbering resources, namely, a number or numbers in national or international numbering plans, or which does not enable communication with a number or numbers in national or international numbering plans; (8) ‘public electronic communications network’ means an electronic communications network used wholly or mainly for the provision of publicly available electronic communications services which support the transfer of information between network termination points; (9) ‘network termination point’ means the physical point at which an end-user is provided with access to a public electronic communications network, and which, in the case of networks involving switching or routing, is identified by means of a specific network address, which may be linked to an end-user’s number or name; (10) ‘associated facilities’ means associated services, physical infrastructures and other facilities or elements associated with an electronic communications network or an electronic communications service which enable or support the provision of services via that network or service, or have the potential to do so, and include buildings or entries to buildings, building wiring, antennae, towers and other supporting constructions, ducts, conduits, masts, manholes, and cabinets; (11) ‘associated service’ means a service associated with an electronic communications network or an electronic communications service which enables or supports the provision, self-provision or automated-provision of services via that network or service, or has the potential to do so, and includes number translation or systems offering equivalent functionality, conditional access systems and electronic programme guides (EPGs), as well as other services such as identity, location and presence service; (12) ‘conditional access system’ means any technical measure, authentication system and/or arrangement whereby access to a protected radio or television broadcasting service in intelligible form is made conditional upon subscription or another form of prior individual authorisation; (13) ‘user’ means a natural or legal person using or requesting a publicly available electronic communications service; (14) ‘end-user’ means a user not providing public electronic communications networks or publicly available electronic communications services; (15) ‘consumer’ means any natural person who uses or requests a publicly available electronic communications service for purposes which are outside his or her trade, business, craft or profession; (16) ‘provision of an electronic communications network’ means the establishment, operation, control or making available of such a network; (17) ‘enhanced digital television equipment’ means set-top boxes intended for connection to television sets or integrated digital television sets, able to receive digital interactive television services; (18) ‘application programming interface’ or ‘API’ means the software interface between applications, made available by broadcasters or service providers, and the resources in the enhanced digital television equipment for digital television and radio services; (19) ‘radio spectrum allocation’ means the designation of a given radio spectrum band for use by one or more types of radio communications services, where appropriate, under specified conditions; (20) ‘harmful interference’ means interference which endangers the functioning of a radio navigation service or of other safety services or which otherwise seriously degrades, obstructs or repeatedly interrupts a radio communications service operating in accordance with the applicable international, Union or national regulations; (21) ‘security of networks and services’ means the ability of electronic communications networks and services to resist, at a given level of confidence, any action that compromises the availability, authenticity, integrity or confidentiality of those networks and services, of stored or transmitted or processed data, or of the related services offered by, or accessible via, those electronic communications networks or services; (22) ‘general authorisation’ means a legal framework established by a Member State ensuring rights for the provision of electronic communications networks or services and laying down sector-specific obligations that may apply to all or to specific types of electronic communications networks and services, in accordance with this Directive; (23) ‘small-area wireless access point’ means low-power wireless network access equipment of a small size operating within a small range, using licenced radio spectrum or licence-exempt radio spectrum or a combination thereof, which may be used as part of a public electronic communications network, which may be equipped with one or more low visual impact antennae, and which allows wireless access by users to electronic communications networks regardless of the underlying network topology, be it mobile or fixed; (24) ‘radio local area network’ or ‘RLAN’ means low-power wireless access system, operating within a small range, with a low risk of interference with other such systems deployed in close proximity by other users, using, on a non-exclusive basis, harmonised radio spectrum; (25) ‘harmonised radio spectrum’ means radio spectrum for which harmonised conditions relating to its availability and efficient use have been established by way of technical implementing measures in accordance with Article 4 of Decision No 676/2002/EC; (26) ‘shared use of radio spectrum’ means access by two or more users to use the same radio spectrum bands under a defined sharing arrangement, authorised on the basis of a general authorisation, individual rights of use for radio spectrum or a combination thereof, including regulatory approaches such as licensed shared access aiming to facilitate the shared use of a radio spectrum band, subject to a binding agreement of all parties involved, in accordance with sharing rules as included in their rights of use for radio spectrum in order to guarantee to all users predictable and reliable sharing arrangements, and without prejudice to the application of competition law; (27) ‘access’ means the making available of facilities or services to another undertaking, under defined conditions, either on an exclusive or a non-exclusive basis, for the purpose of providing electronic communications services, including when they are used for the delivery of information society services or broadcast content services; it covers, inter alia: access to network elements and associated facilities, which may involve the connection of equipment, by fixed or non-fixed means (in particular this includes access to the local loop and to facilities and services necessary to provide services over the local loop); access to physical infrastructure including buildings, ducts and masts; access to relevant software systems including operational support systems; access to information systems or databases for pre-ordering, provisioning, ordering, maintaining and repair requests, and billing; access to number translation or systems offering equivalent functionality; access to fixed and mobile networks, in particular for roaming; access to conditional access systems for digital television services and access to virtual network services; (28) ‘interconnection’ means a specific type of access implemented between public network operators by means of the physical and logical linking of public electronic communications networks used by the same or a different undertaking in order to allow the users of one undertaking to communicate with users of the same or another undertaking, or to access services provided by another undertaking where such services are provided by the parties involved or other parties who have access to the network; (29) ‘operator’ means an undertaking providing or authorised to provide a public electronic communications network or an associated facility; (30) ‘local loop’ means the physical path used by electronic communications signals connecting the network termination point to a distribution frame or equivalent facility in the fixed public electronic communications network; (31) ‘call’ means a connection established by means of a publicly available interpersonal communications service allowing two-way voice communication; (32) ‘voice communications service’ means a publicly available electronic communications service for originating and receiving, directly or indirectly, national or national and international calls through a number or numbers in a national or international numbering plan; (33) ‘geographic number’ means a number from the national numbering plan where part of its digit structure contains geographic significance used for routing calls to the physical location of the network termination point; (34) ‘non-geographic number’ means a number from the national numbering plan that is not a geographic number, such as mobile, freephone and premium-rate numbers; (35) ‘total conversation service’ means a multimedia real time conversation service that provides bidirectional symmetric real time transfer of motion video, real time text and voice between users in two or more locations; (36) ‘public safety answering point’ or ‘PSAP’ means a physical location where an emergency communication is first received under the responsibility of a public authority or a private organisation recognised by the Member State; (37) ‘most appropriate PSAP’ means a PSAP established by responsible authorities to cover emergency communications from a certain area or for emergency communications of a certain type; (38) ‘emergency communication’ means communication by means of interpersonal communications services between an end-user and the PSAP with the goal to request and receive emergency relief from emergency services; (39) ‘emergency service’ means a service, recognised as such by the Member State, that provides immediate and rapid assistance in situations where there is, in particular, a direct risk to life or limb, to individual or public health or safety, to private or public property, or to the environment, in accordance with national law; (40) ‘caller location information’ means, in a public mobile network, the data processed, derived from network infrastructure or handsets, indicating the geographic position of an end-user’s mobile terminal equipment, and, in a public fixed network, the data about the physical address of the network termination point; (41) ‘terminal equipment’ means terminal equipment as defined in point (1) of Article 1 of Commission Directive 2008/63/EC (43); (42) ‘security incident’ means an event having an actual adverse effect on the security of electronic communications networks or services. CHAPTER II Objectives Article 3 General objectives 1. Member States shall ensure that in carrying out the regulatory tasks specified in this Directive, the national regulatory and other competent authorities take all reasonable measures which are necessary and proportionate for achieving the objectives set out in paragraph 2. Member States, the Commission, the Radio Spectrum Policy Group (‘RSPG’), and BEREC shall also contribute to the achievement of those objectives. National regulatory and other competent authorities shall contribute within their competence to ensuring the implementation of policies aimed at the promotion of freedom of expression and information, cultural and linguistic diversity, as well as media pluralism. 2. In the context of this Directive, the national regulatory and other competent authorities as well as BEREC, the Commission and the Member States shall pursue each of the following general objectives, which are not listed in order of priority: (a) promote connectivity and access to, and take-up of, very high capacity networks, including fixed, mobile and wireless networks, by all citizens and businesses of the Union; (b) promote competition in the provision of electronic communications networks and associated facilities, including efficient infrastructure-based competition, and in the provision of electronic communications services and associated services; (c) contribute to the development of the internal market by removing remaining obstacles to, and facilitating convergent conditions for, investment in, and the provision of, electronic communications networks, electronic communications services, associated facilities and associated services, throughout the Union, by developing common rules and predictable regulatory approaches, by favouring the effective, efficient and coordinated use of radio spectrum, open innovation, the establishment and development of trans-European networks, the provision, availability and interoperability of pan-European services, and end-to-end connectivity; (d) promote the interests of the citizens of the Union, by ensuring connectivity and the widespread availability and take-up of very high capacity networks, including fixed, mobile and wireless networks, and of electronic communications services, by enabling maximum benefits in terms of choice, price and quality on the basis of effective competition, by maintaining the security of networks and services, by ensuring a high and common level of protection for end-users through the necessary sector-specific rules and by addressing the needs, such as affordable prices, of specific social groups, in particular end-users with disabilities, elderly end-users and end-users with special social needs, and choice and equivalent access for end-users with disabilities. 3. Where the Commission establishes benchmarks and reports on the effectiveness of Member States’ measures towards achieving the objectives referred to in paragraph 2, the Commission shall, where necessary, be assisted by Member States, national regulatory authorities, BEREC and the RSPG. 4. The national regulatory and other competent authorities shall, in pursuit of the policy objectives referred to in paragraph 2 and specified in this paragraph, inter alia: (a) promote regulatory predictability by ensuring a consistent regulatory approach over appropriate review periods and through cooperation with each other, with BEREC, with the RSPG and with the Commission; (b) ensure that, in similar circumstances, there is no discrimination in the treatment of providers of electronic communications networks and services; (c) apply Union law in a technologically neutral fashion, to the extent that this is consistent with the achievement of the objectives set out in paragraph 2; (d) promote efficient investment and innovation in new and enhanced infrastructures, including by ensuring that any access obligation takes appropriate account of the risk incurred by the investing undertakings and by permitting various cooperative arrangements between investors and parties seeking access to diversify the risk of investment, while ensuring that competition in the market and the principle of non-discrimination are preserved; (e) take due account of the variety of conditions relating to infrastructure, competition, the circumstances of end-users and, in particular, consumers in the various geographic areas within a Member State, including local infrastructure managed by natural persons on a not-for-profit basis; (f) impose ex ante regulatory obligations only to the extent necessary to secure effective and sustainable competition in the interest of end-users and relax or lift such obligations as soon as that condition is fulfilled. Member States shall ensure that the national regulatory and other competent authorities act impartially, objectively, transparently and in a non-discriminatory and proportionate manner. Article 4 Strategic planning and coordination of radio spectrum policy 1. Member States shall cooperate with each other and with the Commission in the strategic planning, coordination and harmonisation of the use of radio spectrum in the Union in accordance with Union policies for the establishment and functioning of the internal market in electronic communications. To that end, they shall take into consideration, inter alia, the economic, safety, health, public interest, freedom of expression, cultural, scientific, social and technical aspects of Union policies, as well as the various interests of radio spectrum user communities, with the aim of optimising the use of radio spectrum and avoiding harmful interference. 2. By cooperating with each other and with the Commission, Member States shall promote the coordination of radio spectrum policy approaches in the Union and, where appropriate, harmonised conditions with regard to the availability and efficient use of radio spectrum necessary for the establishment and functioning of the internal market in electronic communications. 3. Member States shall, through the RSPG, cooperate with each other and with the Commission in accordance with paragraph 1, and upon their request with the European Parliament and with the Council, in support of the strategic planning and coordination of radio spectrum policy approaches in the Union, by: (a) developing best practices on radio spectrum related matters, with a view to implementing this Directive; (b) facilitating the coordination between Member States with a view to implementing this Directive and other Union law and to contributing to the development of the internal market; (c) coordinating their approaches to the assignment and authorisation of use of radio spectrum and publishing reports or opinions on radio spectrum related matters. BEREC shall participate on issues concerning its competence relating to market regulation and competition related to radio spectrum. 4. The Commission, taking utmost account of the opinion of the RSPG, may submit legislative proposals to the European Parliament and to the Council for the purpose of establishing multiannual radio spectrum policy programmes, setting out the policy orientations and objectives for the strategic planning and harmonisation of the use of radio spectrum in accordance with this Directive, as well as for the purpose of releasing harmonised radio spectrum for shared use or for use not subject to individual rights. TITLE II INSTITUTIONAL SET-UP AND GOVERNANCE CHAPTER I National regulatory and other competent authorities Article 5 National regulatory and other competent authorities 1. Member States shall ensure that each of the tasks laid down in this Directive is undertaken by a competent authority. Within the scope of this Directive, the national regulatory authorities shall be responsible at least for the following tasks: (a) implementing ex ante market regulation, including the imposition of access and interconnection obligations; (b) ensuring the resolution of disputes between undertakings; (c) carrying out radio spectrum management and decisions or, where those tasks are assigned to other competent authorities, providing advice regarding the market-shaping and competition elements of national processes related to the rights of use for radio spectrum for electronic communications networks and services; (d) contributing to the protection of end-user rights in the electronic communications sector, in coordination, where relevant, with other competent authorities; (e) assessing and monitoring closely market-shaping and competition issues regarding open internet access; (f) assessing the unfair burden and calculating the net cost of the provision of universal service; (g) ensuring number portability between providers; (h) performing any other task that this Directive reserves to national regulatory authorities. Member States may assign other tasks provided for in this Directive and other Union law to national regulatory authorities, in particular, those related to market competition or market entry, such as general authorisation, and those related to any role conferred on BEREC. Where those tasks related to market competition or market entry are assigned to other competent authorities, they shall seek to consult the national regulatory authority before taking a decision. For the purposes of contributing to BEREC's tasks, national regulatory authorities shall be entitled to collect necessary data and other information from market participants. Member States may also assign to national regulatory authorities other tasks on the basis of national law, including national law implementing Union law. Member States shall, in particular, promote stability of competences of the national regulatory authorities when transposing this Directive with regard to the attribution of tasks resulting from the Union electronic communications regulatory framework as amended in 2009. 2. National regulatory and other competent authorities of the same Member State or of different Member States shall, where necessary, enter into cooperative arrangements with each other to foster regulatory cooperation. 3. Member States shall publish the tasks to be undertaken by national regulatory and other competent authorities in an easily accessible form, in particular where those tasks are assigned to more than one body. Member States shall ensure, where appropriate, consultation and cooperation between those authorities, and between those authorities and national authorities entrusted with the implementation of competition law or consumer law, on matters of common interest. Where more than one authority has competence to address such matters, Member States shall ensure that the respective tasks of each authority are published in an easily accessible form. 4. Member States shall notify to the Commission all national regulatory and other competent authorities that are assigned tasks under this Directive, and their respective responsibilities, as well as any change thereof. Article 6 Independence of national regulatory and other competent authorities 1. Member States shall guarantee the independence of national regulatory authorities and of other competent authorities by ensuring that they are legally distinct from, and functionally independent of, any natural or legal person providing electronic communications networks, equipment or services. Member States that retain ownership or control of undertakings providing electronic communications networks or services shall ensure effective structural separation of the regulatory function from activities associated with ownership or control. 2. Member States shall ensure that national regulatory and other competent authorities exercise their powers impartially, transparently and in a timely manner. Member States shall ensure that they have adequate technical, financial and human resources to carry out the tasks assigned to them. Article 7 Appointment and dismissal of members of national regulatory authorities 1. The head of a national regulatory authority, or, where applicable, the members of the collegiate body fulfilling that function within a national regulatory authority or their alternates, shall be appointed for a term of office of at least three years from among persons of recognised standing and professional experience, on the basis of merit, skills, knowledge and experience and following an open and transparent selection procedure. Member States shall ensure continuity of decision-making. 2. Member States shall ensure that the head of a national regulatory authority, or where applicable, members of the collegiate body fulfilling that function within a national regulatory authority or their alternates may be dismissed during their term only if they no longer fulfil the conditions required for the performance of their duties which are laid down in national law before their appointment. 3. The decision to dismiss the head of the national regulatory authority concerned, or where applicable members of the collegiate body fulfilling that function, shall be made public at the time of dismissal. The dismissed head of the national regulatory authority or, where applicable, members of the collegiate body fulfilling that function shall receive a statement of reasons. In the event that the statement of reasons is not published, it shall be published upon that person’s request. Member States shall ensure that this decision is subject to review by a court, on points of fact as well as on points of law. Article 8 Political independence and accountability of the national regulatory authorities 1. Without prejudice to Article 10, national regulatory authorities shall act independently and objectively, including in the development of internal procedures and the organisation of staff, shall operate in a transparent and accountable manner in accordance with Union law, and shall not seek or take instructions from any other body in relation to the exercise of the tasks assigned to them under national law implementing Union law. This shall not prevent supervision in accordance with national constitutional law. Only appeal bodies set up in accordance with Article 31 shall have the power to suspend or overturn decisions of the national regulatory authorities. 2. National regulatory authorities shall report annually, inter alia, on the state of the electronic communications market, on the decisions they issue, on their human and financial resources and how those resources are attributed, as well as on future plans. Their reports shall be made public. Article 9 Regulatory capacity of national regulatory authorities 1. Member States shall ensure that national regulatory authorities have separate annual budgets and have autonomy in the implementation of the allocated budget. Those budgets shall be made public. 2. Without prejudice to the obligation to ensure that national regulatory authorities have adequate financial and human resources to carry out the task assigned to them, financial autonomy shall not prevent supervision or control in accordance with national constitutional law. Any control on the budget of the national regulatory authorities shall be exercised in a transparent manner and made public. 3. Member States shall also ensure that national regulatory authorities have adequate financial and human resources to enable them to actively participate in and contribute to BEREC. Article 10 Participation of national regulatory authorities in BEREC 1. Member States shall ensure that the goals of BEREC of promoting greater regulatory coordination and consistency are actively supported by their respective national regulatory authorities. 2. Member States shall ensure that national regulatory authorities take utmost account of guidelines, opinions, recommendations, common positions, best practices and methodologies adopted by BEREC when adopting their own decisions for their national markets. Article 11 Cooperation with national authorities National regulatory authorities, other competent authorities under this Directive, and national competition authorities shall provide each other with the information necessary for the application of this Directive. In respect of the information exchanged, Union data protection rules shall apply, and the receiving authority shall ensure the same level of confidentiality as that of the originating authority. CHAPTER II General authorisation Section 1 General part Article 12 General authorisation of electronic communications networks and services 1. Member States shall ensure the freedom to provide electronic communications networks and services, subject to the conditions set out in this Directive. To this end, Member States shall not prevent an undertaking from providing electronic communications networks or services, except where this is necessary for the reasons set out in Article 52(1) TFEU. Any such limitation to the freedom to provide electronic communications networks and services shall be duly reasoned and shall be notified to the Commission. 2. The provision of electronic communications networks or services, other than number-independent interpersonal communications services, may, without prejudice to the specific obligations referred to in Article 13(2) or rights of use referred to in Articles 46 and 94, be subject only to a general authorisation. 3. Where a Member State considers that a notification requirement is justified for undertakings subject to a general authorisation, that Member State may require such undertakings only to submit a notification to the national regulatory or other competent authority. The Member State shall not require such undertakings to obtain an explicit decision or any other administrative act by such authority or by any other authority before exercising the rights derived from the general authorisation. Upon notification, when required, an undertaking may start the activity, where necessary subject to the provisions on the rights of use under this Directive. 4. The notification referred to in paragraph 3 shall not entail more than a declaration by a natural or legal person to the national regulatory or other competent authority of the intention to start the provision of electronic communications networks or services and the submission of the minimal information which is required to allow BEREC and that authority to keep a register or list of providers of electronic communications networks and services. That information shall be limited to: (a) the name of the provider; (b) the provider’s legal status, form and registration number, where the provider is registered in a trade or other similar public register in the Union; (c) the geographical address of the provider’s main establishment in the Union, if any, and, where applicable, any secondary branch in a Member State; (d) the provider’s website address, where applicable, associated with the provision of electronic communications networks or services; (e) a contact person and contact details; (f) a short description of the networks or services intended to be provided; (g) the Member States concerned; and (h) an estimated date for starting the activity. Member States shall not impose any additional or separate notification requirements. In order to approximate notification requirements, BEREC shall publish guidelines for the notification template and maintain a Union database of the notifications transmitted to the competent authorities. To that end, the competent authorities shall, by electronic means, forward each notification received to BEREC without undue delay. Notifications made to the competent authorities before 21 December 2020 shall be forwarded to BEREC by 21 December 2021. Article 13 Conditions attached to the general authorisation and to the rights of use for radio spectrum and for numbering resources, and specific obligations 1. The general authorisation for the provision of electronic communications networks or services and the rights of use for radio spectrum and rights of use for numbering resources may be subject only to the conditions listed in Annex I. Such conditions shall be non-discriminatory, proportionate and transparent. In the case of rights of use for radio spectrum, such conditions shall ensure the effective and efficient use thereof and be in accordance with Articles 45 and 51, and, in the case of rights of use for numbering resources, shall be in accordance with Article 94. 2. Specific obligations which may be imposed on undertakings providing electronic communications networks and services under Article 61(1) and (5) and Articles 62, 68 and 83 or on those designated to provide universal service under this Directive shall be legally separate from the rights and obligations under the general authorisation. In order to achieve transparency, the criteria and procedures for imposing such specific obligations on individual undertakings shall be referred to in the general authorisation. 3. The general authorisation shall contain only conditions which are specific for that sector and are set out in Parts A, B and C of Annex I and shall not duplicate conditions which are applicable to undertakings by virtue of other national law. 4. Member States shall not duplicate the conditions of the general authorisation where they grant the right of use for radio spectrum or for numbering resources. Article 14 Declarations to facilitate the exercise of rights to install facilities and rights of interconnection Competent authorities shall, within one week of the request of an undertaking, issue standardised declarations confirming, where applicable, that the undertaking has submitted a notification under Article 12(3). Those declarations shall detail the circumstances under which any undertaking providing electronic communications networks or services under the general authorisation has the right to apply for rights to install facilities, negotiate interconnection, and obtain access or interconnection, in order to facilitate the exercise of those rights, for instance at other levels of government or in relation to other undertakings. Where appropriate, such declarations may also be issued as an automatic reply following the notification referred to in Article 12(3). Section 2 General authorisation rights and obligations Article 15 Minimum list of rights derived from the general authorisation 1. Undertakings subject to the general authorisation pursuant to Article 12, shall have the right to: (a) provide electronic communications networks and services; (b) have their application for the necessary rights to install facilities considered in accordance with Article 43; (c) use, subject to Articles 13, 46 and 55, radio spectrum in relation to electronic communications networks and services; (d) have their application for the necessary rights of use for numbering resources considered in accordance with Article 94. 2. Where such undertakings provide electronic communications networks or services to the public, the general authorisation shall give them the right to: (a) negotiate interconnection with and, where applicable, obtain access to, or interconnection from, other providers of public electronic communications networks or publicly available electronic communications services covered by a general authorisation in the Union in accordance with this Directive; (b) be given an opportunity to be designated to provide different elements of the universal service or to cover different parts of the national territory in accordance with Article 86 or 87. Article 16 Administrative charges 1. Any administrative charges imposed on undertakings providing electronic communications networks or services under the general authorisation or to which a right of use has been granted shall: (a) cover, in total, only the administrative costs incurred in the management, control and enforcement of the general authorisation system and of the rights of use and of specific obligations as referred to in Article 13(2), which may include costs for international cooperation, harmonisation and standardisation, market analysis, monitoring compliance and other market control, as well as regulatory work involving preparation and enforcement of secondary legislation and administrative decisions, such as decisions on access and interconnection; and (b) be imposed upon the individual undertakings in an objective, transparent and proportionate manner which minimises additional administrative costs and associated charges. Member States may choose not to apply administrative charges to undertakings the turnover of which is below a certain threshold or the activities of which do not reach a minimum market share or have a very limited territorial scope. 2. Where national regulatory or other competent authorities impose administrative charges, they shall publish an annual overview of their administrative costs and of the total sum of the charges collected. Where there is a difference between the total sum of the charges and the administrative costs, appropriate adjustments shall be made. Article 17 Accounting separation and financial reports 1. Member States shall require undertakings providing public electronic communications networks or publicly available electronic communications services which have special or exclusive rights for the provision of services in other sectors in the same or another Member State to: (a) keep separate accounts for the activities associated with the provision of electronic communications networks or services, to the extent that would be required if those activities were carried out by legally independent entities, in order to identify all elements of cost and revenue, with the basis of their calculation and the detailed attribution methods used, related to such activities, including an itemised breakdown of fixed assets and structural costs; or (b) have structural separation for the activities associated with the provision of electronic communications networks or services. Member States may choose not to apply the requirements referred to in the first subparagraph to undertakings which have an annual turnover of less than EUR 50 million in activities associated with electronic communications networks or services in the Union. 2. Where undertakings providing public electronic communications networks or publicly available electronic communications services are not subject to the requirements of company law and do not satisfy the small and medium-sized enterprise criteria of Union law accounting rules, their financial reports shall be drawn up and submitted to independent audit and published. The audit shall be carried out in accordance with the relevant Union and national rules. The first subparagraph of this paragraph shall also apply to the separate accounts required under point (a) of the first subparagraph of paragraph 1. Section 3 Amendment and withdrawal Article 18 Amendment of rights and obligations 1. Member States shall ensure that the rights, conditions and procedures concerning general authorisations and rights of use for radio spectrum or for numbering resources or rights to install facilities may be amended only in objectively justified cases and in a proportionate manner, taking into consideration, where appropriate, the specific conditions applicable to transferable rights of use for radio spectrum or for numbering resources. 2. Except where proposed amendments are minor and have been agreed with the holder of the rights or of the general authorisation, notice shall be given in an appropriate manner of the intention to make such amendments. Interested parties, including users and consumers, shall be allowed a sufficient period of time to express their views on the proposed amendments. That period shall be no less than four weeks except in exceptional circumstances. Amendments shall be published, together with the reasons therefor. Article 19 Restriction or withdrawal of rights 1. Without prejudice to Article 30(5) and (6), Member States shall not restrict or withdraw rights to install facilities or rights of use for radio spectrum or for numbering resources before the expiry of the period for which they were granted, except where justified pursuant to paragraph 2 of this Article, and, where applicable, in accordance with Annex I, and to relevant national provisions regarding compensation for the withdrawal of rights. 2. In line with the need to ensure the effective and efficient use of radio spectrum, or the implementation of the technical implementing measures adopted under Article 4 of Decision No 676/2002/EC, Member States may allow the restriction or withdrawal of rights of use for radio spectrum, including the rights referred to in Article 49 of this Directive, based on pre-established and clearly defined procedures, in accordance with the principles of proportionality and non-discrimination. In such cases, the holders of the rights may, where appropriate and in accordance with Union law and relevant national provisions, be compensated appropriately. 3. A modification in the use of radio spectrum as a result of the application of Article 45(4) or (5) shall not alone constitute grounds to justify the withdrawal of a right of use for radio spectrum. 4. Any intention to restrict or withdraw rights under the general authorisation or individual rights of use for radio spectrum or for numbering resources without the consent of the holder of the rights shall be subject to consultation of the interested parties in accordance with Article 23. CHAPTER III Provision of information, surveys and consultation mechanism Article 20 Information request to undertakings 1. Member States shall ensure that undertakings providing electronic communications networks and services, associated facilities, or associated services, provide all the information, including financial information, necessary for national regulatory authorities, other competent authorities and BEREC to ensure conformity with the provisions of, or decisions or opinions adopted in accordance with, this Directive and Regulation (EU) 2018/1971 of the European Parliament and of the Council (44). In particular, national regulatory authorities and, where necessary for performing their tasks, other competent authorities shall have the power to require those undertakings to submit information concerning future network or service developments that could have an impact on the wholesale services that they make available to competitors, as well as information on electronic communications networks and associated facilities, which is disaggregated at local level and sufficiently detailed to enable the geographical survey and designation of areas in accordance with Article 22. Where the information collected in accordance with the first subparagraph is insufficient for national regulatory authorities, other competent authorities and BEREC to carry out their regulatory tasks under Union law, such information may be inquired from other relevant undertakings active in the electronic communications or closely related sectors. Undertakings designated as having significant market power on wholesale markets may also be required to submit accounting data on the retail markets that are associated with those wholesale markets. National regulatory and other competent authorities may request information from the single information points established pursuant to Directive 2014/61/EU. Any request for information shall be proportionate to the performance of the task and shall be reasoned. Undertakings shall provide the information requested promptly and in accordance with the timescales and level of detail required. 2. Member States shall ensure that national regulatory and other competent authorities provide the Commission, after a reasoned request, with the information necessary for it to carry out its tasks under the TFEU. The information requested by the Commission shall be proportionate to the performance of those tasks. Where the information provided refers to information previously provided by undertakings at the request of the authority, such undertakings shall be informed thereof. To the extent necessary, and unless the authority that provides the information has made an explicit and reasoned request to the contrary, the Commission shall make the information provided available to another such authority in another Member State. Subject to the requirements of paragraph 3, Member States shall ensure that the information submitted to one authority can be made available to another such authority in the same or different Member State and to BEREC, after a substantiated request, where necessary to allow either authority, or BEREC, to fulfil its responsibilities under Union law. 3. Where information gathered pursuant to paragraph 1, including information gathered in the context of a geographical survey, is considered to be confidential by a national regulatory or other competent authority in accordance with Union and national rules on commercial confidentiality, the Commission, BEREC and any other competent authorities concerned shall ensure such confidentiality. Such confidentiality shall not prevent the sharing of information between the competent authority, the Commission, BEREC and any other competent authorities concerned in a timely manner for the purposes of reviewing, monitoring and supervising the application of this Directive. 4. Member States shall ensure that, acting in accordance with national rules on public access to information and subject to Union and national rules on commercial confidentiality and protection of personal data, national regulatory and other competent authorities publish information that contributes to an open and competitive market. 5. National regulatory and other competent authorities shall publish the terms of public access to information as referred to in paragraph 4, including the procedures for obtaining such access. Article 21 Information required with regard to the general authorisation, rights of use and specific obligations 1. Without prejudice to any information requested pursuant to Article 20 and information and reporting obligations under national law other than the general authorisation, national regulatory and other competent authorities may require undertakings to provide information with regard to the general authorisation, the rights of use or the specific obligations referred to in Article 13(2), which is proportionate and objectively justified in particular for the purposes of: (a) verifying, on a systematic or case-by-case basis, compliance with condition 1 of Part A, conditions 2 and 6 of Part D, and conditions 2 and 7 of Part E, of Annex I and of compliance with obligations as referred to in Article 13(2); (b) verifying, on a case-by-case basis, compliance with conditions as set out in Annex I where a complaint has been received or where the competent authority has other reasons to believe that a condition is not complied with or in the case of an investigation by the competent authority on its own initiative; (c) carrying out procedures for and the assessment of requests for granting rights of use; (d) publishing comparative overviews of quality and price of services for the benefit of consumers; (e) collating clearly defined statistics, reports or studies; (f) carrying out market analyses for the purposes of this Directive, including data on the downstream or retail markets associated with or related to the markets which are the subject of the market analysis; (g) safeguarding the efficient use and ensuring the effective management of radio spectrum and of numbering resources; (h) evaluating future network or service developments that could have an impact on wholesale services made available to competitors, on territorial coverage, on connectivity available to end-users or on the designation of areas pursuant to Article 22; (i) conducting geographical surveys; (j) responding to reasoned requests for information by BEREC. The information referred to in points (a) and (b), and (d) to (j) of the first subparagraph shall not be required prior to, or as a condition for, market access. BEREC may develop templates for information requests, where necessary, to facilitate consolidated presentation and analysis of the information obtained. 2. As regards the rights of use for radio spectrum, the information referred to in paragraph 1 shall refer in particular to the effective and efficient use of radio spectrum as well as to compliance with any coverage and quality of service obligations attached to the rights of use for radio spectrum and their verification. 3. Where national regulatory or other competent authorities require undertakings to provide information as referred to in paragraph 1, they shall inform them of the specific purpose for which this information is to be used. 4. National regulatory or other competent authorities shall not duplicate requests of information already made by BEREC pursuant to Article 40 of Regulation (EU) 2018/1971 where BEREC has made the information received available to those authorities. Article 22 Geographical surveys of network deployments 1. National regulatory and/or other competent authorities shall conduct a geographical survey of the reach of electronic communications networks capable of delivering broadband (‘broadband networks’) by 21 December 2023 and shall update it at least every three years thereafter. The geographical survey shall include a survey of the current geographic reach of broadband networks within their territory, as required for the tasks of national regulatory and/or other competent authorities under this Directive and for the surveys required for the application of State aid rules. The geographical survey may also include a forecast for a period determined by the relevant authority of the reach of broadband networks, including very high capacity networks, within their territory. Such forecast shall include all relevant information, including information on planned deployments by any undertaking or public authority, of very high capacity networks and significant upgrades or extensions of networks to at least 100 Mbps download speeds. For this purpose, national regulatory and/or other competent authorities shall request undertakings and public authorities to provide such information to the extent that it is available and can be provided with reasonable effort. The national regulatory authority shall decide, with respect to tasks specifically attributed to it under this Directive, the extent to which it is appropriate to rely on all or part of the information gathered in the context of such forecast. Where a geographical survey is not conducted by the national regulatory authority, it shall be done in cooperation with that authority to the extent it may be relevant for its tasks. The information collected in the geographical survey shall be at an appropriate level of local detail and shall include sufficient information on the quality of service and parameters thereof and shall be treated in accordance with Article 20(3). 2. National regulatory and/or other competent authorities may designate an area with clear territorial boundaries where, on the basis of the information gathered and any forecast prepared pursuant to paragraph 1, it is determined that, for the duration of the relevant forecast period, no undertaking or public authority has deployed or is planning to deploy a very high capacity network or significantly upgrade or extend its network to a performance of at least 100 Mbps download speeds. National regulatory and/or other competent authorities shall publish the designated areas. 3. Within a designated area, the relevant authorities may invite undertakings and public authorities to declare their intention to deploy very high capacity networks over the duration of the relevant forecast period. Where this invitation results in a declaration by an undertaking or public authority of its intention to do so, the relevant authority may require other undertakings and public authorities to declare any intention to deploy very high capacity networks, or significantly upgrade or extend its network to a performance of at least 100 Mbps download speeds in this area. The relevant authority shall specify the information to be included in such submissions, in order to ensure at least a similar level of detail as that taken into consideration in any forecast pursuant to paragraph 1. It shall also inform any undertaking or public authority expressing its interest whether the designated area is covered or likely to be covered by a next-generation access network offering download speeds below 100 Mbps on the basis of the information gathered pursuant to paragraph 1. 4. Measures pursuant to paragraph 3 shall be taken in accordance with an efficient, objective, transparent and non-discriminatory procedure, whereby no undertaking is excluded a priori. 5. Member States shall ensure that national regulatory and other competent authorities, and local, regional and national authorities with responsibility for the allocation of public funds for the deployment of electronic communications networks, for the design of national broadband plans, for defining coverage obligations attached to rights of use for radio spectrum and for verifying availability of services falling within the universal service obligations in their territory take into account the results of the geographical survey and of any designated areas pursuant to paragraphs 1, 2 and 3. Member States shall ensure that the authorities conducting the geographical survey shall supply those results subject to the receiving authority ensuring the same level of confidentiality and protection of business secrets as the originating authority and inform the parties which provided the information. Those results shall also be made available to BEREC and the Commission upon their request and under the same conditions. 6. If the relevant information is not available on the market, competent authorities shall make data from the geographical surveys which are not subject to commercial confidentiality directly accessible in accordance with Directive 2003/98/EC to allow for its reuse. They shall also, where such tools are not available on the market, make available information tools enabling end-users to determine the availability of connectivity in different areas, with a level of detail which is useful to support their choice of operator or service provider. 7. By 21 June 2020, in order to contribute to the consistent application of geographical surveys and forecasts, BEREC shall, after consulting stakeholders and in close cooperation with the Commission and relevant national authorities, issue guidelines to assist national regulatory and/or other competent authorities on the consistent implementation of their obligations under this Article. Article 23 Consultation and transparency mechanism 1. Except in cases falling within Article 26 or 27 or Article 32(10), Member States shall ensure that, where national regulatory or other competent authorities intend to take measures in accordance with this Directive, or where they intend to provide for restrictions in accordance with Article 45(4) and (5), which have a significant impact on the relevant market, they give interested parties the opportunity to comment on the draft measure within a reasonable period, having regard to the complexity of the matter and, except in exceptional circumstances, in any event not shorter than 30 days. 2. For the purposes of Article 35, the competent authorities shall inform the RSPG at the moment of publication about any draft measure which falls within the scope of the comparative or competitive selection procedure pursuant to Article 55(2) and relates to the use of radio spectrum for which harmonised conditions have been set by technical implementing measures in accordance with Decision No 676/2002/EC in order to enable its use for wireless broadband electronic communications networks and services (‘wireless broadband networks and services’). 3. National regulatory and other competent authorities shall publish their national consultation procedures. Member States shall ensure the establishment of a single information point through which all current consultations can be accessed. 4. The results of the consultation procedure shall be made publicly available, except in the case of confidential information in accordance with Union and national rules on commercial confidentiality. Article 24 Consultation of interested parties 1. Member States shall ensure, as appropriate, that competent authorities in coordination, where relevant, with national regulatory authorities take account of the views of end-users, in particular consumers, and end-users with disabilities, manufacturers and undertakings that provide electronic communications networks or services on issues related to all end-user and consumer rights, including equivalent access and choice for end-users with disabilities, concerning publicly available electronic communications services, in particular where they have a significant impact on the market. Member States shall ensure that competent authorities in coordination, where relevant, with national regulatory authorities establish a consultation mechanism, accessible for end-users with disabilities, ensuring that in their decisions on issues related to end-user and consumer rights concerning publicly available electronic communications services, due consideration is given to consumer interests in electronic communications. 2. Interested parties may develop, with the guidance of competent authorities in coordination, where relevant, with national regulatory authorities, mechanisms, involving consumers, user groups and service providers, to improve the general quality of service provision by, inter alia, developing and monitoring codes of conduct and operating standards. 3. Without prejudice to national rules in accordance with Union law promoting cultural and media policy objectives, such as cultural and linguistic diversity and media pluralism, competent authorities in coordination, where relevant, with national regulatory authorities may promote cooperation between undertakings providing electronic communications networks or services and sectors interested in the promotion of lawful content in electronic communications networks and services. That cooperation may also include coordination of the public-interest information to be provided pursuant to Article 103(4). Article 25 Out-of-court dispute resolution 1. Member States shall ensure that the national regulatory authority or another competent authority responsible for, or at least one independent body with proven expertise in, the application of Articles 102 to 107 and Article 115 of this Directive is listed as an alternative dispute resolution entity in accordance with Article 20(2) of Directive 2013/11/EU with a view to resolving disputes between providers and consumers arising under this Directive and relating to the performance of contracts. Member States may extend access to alternative dispute resolution procedures provided by that authority or body to end-users other than consumers, in particular microenterprises and small enterprises. 2. Without prejudice to Directive 2013/11/EU, where such disputes involve parties in different Member States, Member States shall coordinate their efforts with a view to bringing about a resolution of the dispute. Article 26 Dispute resolution between undertakings 1. In the event of a dispute arising in connection with existing obligations under this Directive between providers of electronic communications networks or services in a Member State, or between such undertakings and other undertakings in the Member State benefiting from obligations of access or interconnection or between providers of electronic communications networks or services in a Member State and providers of associated facilities, the national regulatory authority concerned shall, at the request of either party, and without prejudice to paragraph 2, issue a binding decision to resolve the dispute in the shortest possible time-frame on the basis of clear and efficient procedures, and in any case within four months except in exceptional circumstances. The Member State concerned shall require that all parties cooperate fully with the national regulatory authority. 2. Member States may make provision for national regulatory authorities to decline to resolve a dispute where other mechanisms, including mediation, exist that would better contribute to resolution of the dispute in a timely manner in accordance with the objectives set out in Article 3. The national regulatory authority shall inform the parties thereof without delay. If, after four months, the dispute is not resolved, and if the dispute has not been brought before the courts by the party seeking redress, the national regulatory authority shall issue, at the request of either party, a binding decision to resolve the dispute in the shortest possible time-frame and in any case within four months. 3. In resolving a dispute, the national regulatory authority shall take decisions aimed at achieving the objectives set out in Article 3. Any obligations imposed on an undertaking by the national regulatory authority in resolving a dispute shall comply with this Directive. 4. The decision of the national regulatory authority shall be made available to the public, having regard to the requirements of commercial confidentiality. The national regulatory authority shall provide the parties concerned with a full statement of the reasons on which the decision is based. 5. The procedure referred to in paragraphs 1, 3 and 4 shall not preclude either party from bringing an action before the courts. Article 27 Resolution of cross-border disputes 1. In the event of a dispute arising under this Directive between undertakings in different Member States, paragraphs 2, 3 and 4 of this Article shall apply. Those provisions shall not apply to disputes relating to radio spectrum coordination covered by Article 28. 2. Any party may refer the dispute to the national regulatory authority or authorities concerned. Where the dispute affects trade between Member States, the competent national regulatory authority or authorities shall notify the dispute to BEREC in order to bring about a consistent resolution of the dispute, in accordance with the objectives set out in Article 3. 3. Where such a notification has been made, BEREC shall issue an opinion inviting the national regulatory authority or authorities concerned to take specific action in order to resolve the dispute or to refrain from action, in the shortest possible time-frame, and in any case within four months except in exceptional circumstances. 4. The national regulatory authority or authorities concerned shall await BEREC's opinion before taking any action to resolve the dispute. In exceptional circumstances, where there is an urgent need to act, in order to safeguard competition or protect the interests of end-users, any of the competent national regulatory authorities may, either at the request of the parties or on its own initiative, adopt interim measures. 5. Any obligations imposed on an undertaking by the national regulatory authority as part of the resolution of the dispute shall comply with this Directive, take the utmost account of the opinion adopted by BEREC, and be adopted within one month of such opinion. 6. The procedure referred to in paragraph 2 shall not preclude either party from bringing an action before the courts. Article 28 Radio Spectrum Coordination among Member States 1. Member States and their competent authorities shall ensure that the use of radio spectrum is organised on their territory in a way that no other Member State is prevented from allowing on its territory the use of harmonised radio spectrum in accordance with Union law, especially due to cross-border harmful interference between Member States. Member States shall take all necessary measures to this effect without prejudice to their obligations under international law and relevant international agreements such as the ITU Radio Regulations and the ITU Radio Regional Agreements. 2. Member States shall cooperate with each other, and, where appropriate, through the RSPG, in the cross-border coordination of the use of radio spectrum in order to: (a) ensure compliance with paragraph 1; (b) resolve any problem or dispute in relation to cross-border coordination or cross-border harmful interference between Member States, as well as with third countries, which prevent Member States from using the harmonised radio spectrum in their territory. 3. In order to ensure compliance with paragraph 1, any affected Member State may request the RSPG to use its good offices to address any problem or dispute in relation to cross-border coordination or cross-border harmful interference. Where appropriate, the RSPG may issue an opinion proposing a coordinated solution regarding such a problem or dispute. 4. Where the actions referred to in paragraph 2 or 3 have not resolved the problem or dispute, and at the request of any affected Member State, the Commission may, taking utmost account of any opinion of the RSPG recommending a coordinated solution pursuant to paragraph 3, adopt decisions addressed to the Member States concerned by the unresolved harmful interference issue by means of implementing acts to resolve cross-border harmful interference between two or more Member States which prevent them from using the harmonised radio spectrum in their territory. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 118(4). 5. The Union shall, upon the request of any affected Member State, provide legal, political and technical support to resolve radio spectrum coordination issues with countries neighbouring the Union, including candidate and acceding countries, in such a way that the Member States concerned can observe their obligations under Union law. In the provision of such assistance, the Union shall promote the implementation of Union policies. TITLE III IMPLEMENTATION Article 29 Penalties 1. Member States shall lay down rules on penalties, including, where necessary, fines and non-criminal predetermined or periodic penalties, applicable to infringements of national provisions adopted pursuant to this Directive or of any binding decision adopted by the Commission, the national regulatory or other competent authority pursuant to this Directive, and shall take all measures necessary to ensure that they are implemented. Within the limits of national law, national regulatory and other competent authorities shall have the power to impose such penalties. The penalties provided for shall be appropriate, effective, proportionate and dissuasive. 2. Member States shall provide for penalties in the context of the procedure referred to in Article 22(3) only where an undertaking or public authority knowingly or grossly negligently provides misleading, erroneous or incomplete information. When determining the amount of fines or periodic penalties imposed on an undertaking or public authority for knowingly or grossly negligently providing misleading, erroneous or incomplete information in the context of the procedure referred to in Article 22(3), regard shall be had, inter alia, to whether the behaviour of the undertaking or public authority has had a negative impact on competition and, in particular, whether, contrary to the information originally provided or any update thereof, the undertaking or public authority either has deployed, extended or upgraded a network, or has not deployed a network and has failed to provide an objective justification for that change of plan. Article 30 Compliance with the conditions of the general authorisation or of rights of use for radio spectrum and for numbering resources and compliance with specific obligations 1. Member States shall ensure that their relevant competent authorities monitor and supervise compliance with the conditions of the general authorisation or of rights of use for radio spectrum and for numbering resources, with the specific obligations referred to in Article 13(2) and with the obligation to use radio spectrum effectively and efficiently in accordance with Article 4, Article 45(1) and Article 47. Competent authorities shall have the power to require undertakings subject to the general authorisation or benefitting from rights of use for radio spectrum or for numbering resources to provide all information necessary to verify compliance with the conditions of the general authorisation or of rights of use for radio spectrum and for numbering resources or with the specific obligations referred to in Article 13(2) or Article 47, in accordance with Article 21. 2. Where a competent authority finds that an undertaking does not comply with one or more of the conditions of the general authorisation or of rights of use for radio spectrum and for numbering resources, or with the specific obligations referred to in Article 13(2), it shall notify the undertaking of those findings and give the undertaking the opportunity to state its views, within a reasonable time limit. 3. The competent authority shall have the power to require the cessation of the breach referred to in paragraph 2 either immediately or within a reasonable time limit and shall take appropriate and proportionate measures aimed at ensuring compliance. In this regard, Member States shall empower the competent authorities to impose: (a) where appropriate, dissuasive financial penalties which may include periodic penalties with retroactive effect; and (b) orders to cease or delay provision of a service or bundle of services which, if continued, would result in significant harm to competition, pending compliance with access obligations imposed following a market analysis carried out in accordance with Article 67. The competent authorities shall communicate the measures and the reasons on which they are based to the undertaking concerned without delay and shall stipulate a reasonable period for the undertaking to comply with the measures. 4. Notwithstanding paragraphs 2 and 3 of this Article, Member States shall empower the competent authority to impose, where appropriate, financial penalties on undertakings for failure to provide information, in accordance with the obligations imposed under point (a) or (b) of the first subparagraph of Article 21(1) and Article 69, within a reasonable period set by the competent authority. 5. In the case of a serious breach or repeated breaches of the conditions of the general authorisation or of the rights of use for radio spectrum and for numbering resources, or of the specific obligations referred to in Article 13(2) or Article 47(1) or (2), where measures aimed at ensuring compliance as referred to in paragraph 3 of this Article have failed, Member States shall empower competent authorities to prevent an undertaking from continuing to provide electronic communications networks or services or suspend or withdraw those rights of use. Member States shall empower the competent authority to impose penalties which are effective, proportionate and dissuasive. Such penalties may be applied to cover the period of any breach, even if the breach has subsequently been rectified. 6. Notwithstanding paragraphs 2, 3 and 5 of this Article, the competent authority may take urgent interim measures to remedy the situation in advance of reaching a final decision, where it has evidence of a breach of the conditions of the general authorisation, of the rights of use for radio spectrum and for numbering resources, or of the specific obligations referred to in Article 13(2) or Article 47(1) or (2) which represents an immediate and serious threat to public safety, public security or public health or risks creating serious economic or operational problems for other providers or users of electronic communications networks or services or other users of the radio spectrum. The competent authority shall give the undertaking concerned a reasonable opportunity to state its views and propose any remedies. Where appropriate, the competent authority may confirm the interim measures, which shall be valid for a maximum of three months, but which may, in circumstances where enforcement procedures have not been completed, be extended for a further period of up to three months. 7. Undertakings shall have the right to appeal against measures taken under this Article in accordance with the procedure referred to in Article 31. Article 31 Right of appeal 1. Member States shall ensure that effective mechanisms exist at national level under which any user or undertaking providing electronic communications networks or services or associated facilities who is affected by a decision of a competent authority has the right of appeal against that decision to an appeal body that is independent of the parties involved and of any external intervention or political pressure liable to jeopardise its independent assessment of matters coming before it. This body, which may be a court, shall have the appropriate expertise to enable it to carry out its functions effectively. Member States shall ensure that the merits of the case are duly taken into account. Pending the outcome of the appeal, the decision of the competent authority shall stand, unless interim measures are granted in accordance with national law. 2. Where the appeal body referred to in paragraph 1 of this Article is not judicial in character, it shall always give written reasons for its decision. Furthermore, in such a case, its decision shall be subject to review by a court or a tribunal within the meaning of Article 267 TFEU. Member States shall ensure that the appeal mechanism is effective. 3. Member States shall collect information on the general subject matter of appeals, the number of requests for appeal, the duration of the appeal proceedings and the number of decisions to grant interim measures. Member States shall provide such information, as well as the decisions or judgments, to the Commission and to BEREC upon their reasoned request. TITLE IV INTERNAL MARKET PROCEDURES CHAPTER I Article 32 Consolidating the internal market for electronic communications 1. In carrying out their tasks under this Directive, national regulatory authorities shall take the utmost account of the objectives set out in Article 3. 2. National regulatory authorities shall contribute to the development of the internal market by working with each other and with the Commission and BEREC, in a transparent manner, in order to ensure the consistent application, in all Member States, of this Directive. To this end, they shall, in particular, work with the Commission and BEREC to identify the types of instruments and remedies best suited to address particular types of situations in the market. 3. Except where otherwise provided in recommendations or guidelines adopted pursuant to Article 34 upon completion of the public consultation, if required under Article 23, where a national regulatory authority intends to take a measure which: (a) falls within the scope of Article 61, 64, 67, 68 or 83; and (b) would affect trade between Member States, it shall publish the draft measure and communicate it to the Commission, to BEREC, and to the national regulatory authorities in other Member States, at the same time, stating the reasons for the measure, in accordance with Article 20(3). National regulatory authorities, BEREC and the Commission may comment on that draft measure within one month. The one-month period shall not be extended. 4. The draft measure referred to in paragraph 3 of this Article shall not be adopted for a further two months, where that measure aims to: (a) define a relevant market which is different from those defined in the recommendation referred to in Article 64(1); or (b) designate an undertaking as having, either individually or jointly with others, significant market power, under Article 67(3) or (4); and it would affect trade between Member States, and the Commission has indicated to the national regulatory authority that it considers that the draft measure would create a barrier to the internal market or if it has serious doubts as to its compatibility with Union law and in particular the objectives referred to in Article 3. That two-month period shall not be extended. The Commission shall inform BEREC and national regulatory authorities of its reservations in such a case and simultaneously make them public. 5. BEREC shall publish an opinion on the Commission’s reservations referred to in paragraph 4, indicating whether it considers that the draft measure should be maintained, amended or withdrawn and shall, where appropriate, provide specific proposals to that end. 6. Within the two-month period referred to in paragraph 4, the Commission may either: (a) take a decision requiring the national regulatory authority concerned to withdraw the draft measure; or (b) take a decision to lift its reservations referred to in paragraph 4. The Commission shall take utmost account of the opinion of BEREC before taking a decision. Decisions referred to in point (a) of the first subparagraph shall be accompanied by a detailed and objective analysis of why the Commission considers that the draft measure is not to be adopted, together with specific proposals for amending it. 7. Where the Commission has adopted a decision in accordance with point (a) of the first subparagraph of paragraph 6 of this Article requiring the national regulatory authority to withdraw a draft measure, the national regulatory authority shall amend or withdraw the draft measure within six months of the date of the Commission’s decision. Where the draft measure is amended, the national regulatory authority shall undertake a public consultation in accordance with Article 23, and shall notify the amended draft measure to the Commission in accordance with paragraph 3 of this Article. 8. The national regulatory authority concerned shall take the utmost account of comments of other national regulatory authorities, of BEREC and of the Commission and may, except in the cases covered by paragraph 4 and point (a) of paragraph 6, adopt the resulting draft measure and shall, where it does so, communicate it to the Commission. 9. The national regulatory authority shall communicate to the Commission and to BEREC all adopted final measures which fall under points (a) and (b) of paragraph 3. 10. In exceptional circumstances, where a national regulatory authority considers that there is an urgent need to act, in order to safeguard competition and protect the interests of users, by way of derogation from the procedure set out in paragraphs 3 and 4, it may immediately adopt proportionate and provisional measures. It shall, without delay, communicate those measures, with full reasons, to the Commission, to the other national regulatory authorities, and to BEREC. A decision of the national regulatory authority to render such measures permanent or extend the period for which they are applicable shall be subject to paragraphs 3 and 4. 11. A national regulatory authority may withdraw a draft measure at any time. Article 33 Procedure for the consistent application of remedies 1. Where an intended measure covered by Article 32(3) aims to impose, amend or withdraw an obligation on an undertaking in application of Article 61 or 67 in conjunction with Articles 69 to 76 and Article 83, the Commission may, within the one-month period referred to in Article 32(3), notify the national regulatory authority concerned and BEREC of its reasons for considering that the draft measure would create a barrier to the internal market or of its serious doubts as to its compatibility with Union law. In such a case, the draft measure shall not be adopted for a further three months following the Commission's notification. In the absence of such notification, the national regulatory authority concerned may adopt the draft measure, taking utmost account of any comments made by the Commission, BEREC or any other national regulatory authority. 2. Within the three-month period referred to in paragraph 1 of this Article, the Commission, BEREC and the national regulatory authority concerned shall cooperate closely to identify the most appropriate and effective measure in light of the objectives laid down in Article 3, whilst taking due account of the views of market participants and the need to ensure the development of consistent regulatory practice. 3. Within six weeks from the beginning of the three-month period referred to in paragraph 1, BEREC shall issue an opinion on the Commission’s notification referred to in paragraph 1, indicating whether it considers that the draft measure should be amended or withdrawn and, where appropriate, provide specific proposals to that end. That opinion shall provide reasons and be made public. 4. If in its opinion, BEREC shares the serious doubts of the Commission, it shall cooperate closely with the national regulatory authority concerned to identify the most appropriate and effective measure. Before the end of the three-month period referred to in paragraph 1, the national regulatory authority may either: (a) amend or withdraw its draft measure taking utmost account of the Commission’s notification referred to in paragraph 1 and of BEREC’s opinion; or (b) maintain its draft measure. 5. The Commission may, within one month following the end of the three-month period referred to in paragraph 1 and taking utmost account of the opinion of BEREC, if any: (a) issue a recommendation requiring the national regulatory authority concerned to amend or withdraw the draft measure, including specific proposals to that end and providing reasons for its recommendation, in particular where BEREC does not share the Commission’s serious doubts; (b) take a decision to lift its reservations indicated in accordance with paragraph 1; or (c) for draft measures falling under the second subparagraph of Article 61(3) or under Article 76(2), take a decision requiring the national regulatory authority concerned to withdraw the draft measure, where BEREC shares the serious doubts of the Commission, accompanied by a detailed and objective analysis of why the Commission considers that the draft measure should not be adopted, together with specific proposals for amending the draft measure, subject to the procedure referred to in Article 32(7), which shall apply mutatis mutandis. 6. Within one month of the Commission issuing the recommendation in accordance with point (a) of paragraph 5 or lifting its reservations in accordance with point (b) of paragraph 5, the national regulatory authority concerned shall communicate to the Commission and to BEREC the adopted final measure. That period may be extended to allow the national regulatory authority to undertake a public consultation in accordance with Article 23. 7. Where the national regulatory authority decides not to amend or withdraw the draft measure on the basis of the recommendation issued under point (a) of paragraph 5, it shall provide reasons. 8. The national regulatory authority may withdraw the proposed draft measure at any stage of the procedure. Article 34 Implementing provisions After public consultation and after consulting the national regulatory authorities and taking utmost account of the opinion of BEREC, the Commission may adopt recommendations or guidelines in relation to Article 32 that lay down the form, content and level of detail to be given in the notifications required in accordance with Article 32(3), the circumstances in which notifications would not be required, and the calculation of the time-limits. CHAPTER II Consistent radio spectrum assignment Article 35 Peer review process 1. Where the national regulatory or other competent authority intends to undertake a selection procedure in accordance with Article 55(2) in relation to radio spectrum for which harmonised conditions have been set by technical implementing measures in accordance with Decision No 676/2002/EC in order to enable its use for wireless broadband networks and services, it shall, pursuant to Article 23, inform the RSPG about any draft measure which falls within the scope of the comparative or competitive selection procedure pursuant to Article 55(2) and indicate whether and when it is to request the RSPG to convene a Peer Review Forum. When requested to do so, the RSPG shall organise a Peer Review Forum in order to discuss and exchange views on the draft measures transmitted and shall facilitate the exchange of experiences and best practices on those draft measures. The Peer Review Forum shall be composed of the members of the RSPG and organised and chaired by a representative of the RSPG. 2. At the latest during the public consultation conducted pursuant to Article 23, the RSPG may exceptionally take the initiative to convene a Peer Review Forum in accordance with the rules of procedure for organising it in order to exchange experiences and best practices on a draft measure relating to a selection procedure where it considers that the draft measure would significantly prejudice the ability of the national regulatory or other competent authority to achieve the objectives set in Articles 3, 45, 46 and 47. 3. The RSPG shall define in advance and make public the objective criteria for the exceptional convening of the Peer Review Forum. 4. During the Peer Review Forum, the national regulatory authority or other competent authority shall provide an explanation on how the draft measure: (a) promotes the development of the internal market, the cross-border provision of services, as well as competition, and maximises the benefits for the consumer, and overall achieves the objectives set in Articles 3, 45, 46 and 47 of this Directive, as well as in Decisions No 676/2002/EC and No 243/2012/EU; (b) ensures effective and efficient use of radio spectrum; and (c) ensures stable and predictable investment conditions for existing and prospective radio spectrum users when deploying networks for the provision of electronic communications services which rely on radio spectrum. 5. The Peer Review Forum shall be open to voluntary participation by experts from other competent authorities and from BEREC. 6. The Peer Review Forum shall be convened only once during the overall national preparation and consultation process of a single selection procedure concerning one or several radio spectrum bands, unless the national regulatory or other competent authority requests that it is reconvened. 7. At the request of the national regulatory or other competent authority that requested the meeting, the RSPG may adopt a report on how the draft measure achieves the objectives provided in paragraph 4, reflecting the views exchanged in the Peer Review Forum. 8. The RSPG shall publish in February each year a report concerning the draft measures discussed pursuant to paragraphs 1 and 2. The report shall indicate experiences and best practices noted. 9. Following the Peer Review Forum, at the request of the national regulatory or other competent authority that requested the meeting, the RSPG may adopt an opinion on the draft measure. Article 36 Harmonised assignment of radio spectrum Where the use of radio spectrum has been harmonised, access conditions and procedures have been agreed, and undertakings to which the radio spectrum shall be assigned have been selected in accordance with international agreements and Union rules, Member States shall grant the right of use for such radio spectrum in accordance therewith. Provided that all national conditions attached to the right to use the radio spectrum concerned have been satisfied in the case of a common selection procedure, Member States shall not impose any further conditions, additional criteria or procedures which would restrict, alter or delay the correct implementation of the common assignment of such radio spectrum. Article 37 Joint authorisation process to grant individual rights of use for radio spectrum Two or several Member States may cooperate with each other and with the RSPG, taking into account any interest expressed by market participants, by jointly establishing the common aspects of an authorisation process and, where appropriate, also jointly conducting the selection process to grant individual rights of use for radio spectrum. When designing the joint authorisation process, Members States may take into consideration the following criteria: (a) the individual national authorisation processes shall be initiated and implemented by the competent authorities in accordance with a jointly agreed schedule; (b) it shall provide, where appropriate, for common conditions and procedures for the selection and granting of individual rights of use for radio spectrum among the Member States concerned; (c) it shall provide, where appropriate, for common or comparable conditions to be attached to the individual rights of use for radio spectrum among the Member States concerned, inter alia allowing users to be assigned similar radio spectrum blocks; (d) it shall be open at any time to other Member States until the joint authorisation process has been conducted. Where, in spite of the interest expressed by market participants, Member States do not act jointly, they shall inform those market participants of the reasons explaining their decision. CHAPTER III Harmonisation procedures Article 38 Harmonisation procedures 1. Where the Commission finds that divergences in the implementation by the national regulatory or other competent authorities of the regulatory tasks specified in this Directive could create a barrier to the internal market, the Commission may, taking the utmost account of the opinion of BEREC or, where relevant, the RSPG, adopt recommendations or, subject to paragraph 3 of this Article, decisions by means of implementing acts to ensure the harmonised application of this Directive and in order to further the achievement of the objectives set out in Article 3. 2. Member States shall ensure that national regulatory and other competent authorities take the utmost account of the recommendations referred to in paragraph 1 in carrying out their tasks. Where a national regulatory or other competent authority chooses not to follow a recommendation, it shall inform the Commission, giving the reasons for its position. 3. The decisions adopted pursuant to paragraph 1 shall include only the identification of a harmonised or coordinated approach for the purpose of addressing the following matters: (a) the inconsistent implementation of general regulatory approaches by national regulatory authorities on the regulation of electronic communications markets in the application of Articles 64 and 67, where it creates a barrier to the internal market; such decisions shall not refer to specific notifications issued by the national regulatory authorities pursuant to Article 32; in such a case, the Commission shall propose a draft decision only: (i) after at least two years following the adoption of a Commission recommendation dealing with the same matter; and (ii) taking utmost account of an opinion from BEREC on the case for adoption of such a decision, which shall be provided by BEREC within three months of the Commission’s request; (b) numbering, including number ranges, portability of numbers and identifiers, number and address translation systems, and access to emergency services through the single European emergency number ‘112’. 4. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 118(4). 5. BEREC may, on its own initiative, advise the Commission on whether a measure should be adopted pursuant to paragraph 1. 6. If the Commission has not adopted a recommendation or a decision within one year from the date of adoption of an opinion by BEREC indicating the existence of divergences in the implementation by the national regulatory or other competent authorities of the regulatory tasks specified in this Directive that could create a barrier to the internal market, it shall inform the European Parliament and the Council of its reasons for not doing so, and make those reasons public. Where the Commission has adopted a recommendation in accordance with paragraph 1, but the inconsistent implementation creating barriers to the internal market persists for two years thereafter, the Commission shall, subject to paragraph 3, adopt a decision by means of implementing acts in accordance with paragraph 4. Where the Commission has not adopted a decision within a further year from any recommendation adopted pursuant to the second subparagraph, it shall inform the European Parliament and the Council of its reasons for not doing so, and make those reasons public. Article 39 Standardisation 1. The Commission shall draw up and publish in the Official Journal of the European Union a list of non-compulsory standards or specifications to serve as a basis for encouraging the harmonised provision of electronic communications networks, electronic communications services and associated facilities and associated services. Where necessary, the Commission may, following consultation of the Committee established by Directive (EU) 2015/1535, request that standards be drawn up by the European standardisation organisations (European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardisation (Cenelec), and European Telecommunications Standards Institute (ETSI)). 2. Member States shall encourage the use of the standards or specifications referred to in paragraph 1 for the provision of services, technical interfaces or network functions, to the extent strictly necessary to ensure interoperability of services, end-to-end connectivity, facilitation of provider switching and portability of numbers and identifiers, and to improve freedom of choice for users. In the absence of publication of standards or specifications in accordance with paragraph 1, Member States shall encourage the implementation of standards or specifications adopted by the European standardisation organisations. In the absence of such standards or specifications, Member States shall encourage the implementation of international standards or recommendations adopted by the International Telecommunication Union (ITU), the European Conference of Postal and Telecommunications Administrations (CEPT), the International Organisation for Standardisation (ISO) and the International Electrotechnical Commission (IEC). Where international standards exist, Member States shall encourage the European standardisation organisations to use them, or the relevant parts of them, as a basis for the standards they develop, except where such international standards or relevant parts would be ineffective. Any standards or specifications referred to in paragraph 1 or in this paragraph shall not prevent access as may be required under this Directive, where feasible. 3. If the standards or specifications referred to in paragraph 1 have not been adequately implemented so that interoperability of services in one or more Member States cannot be ensured, the implementation of such standards or specifications may be made compulsory under the procedure laid down in paragraph 4, to the extent strictly necessary to ensure such interoperability and to improve freedom of choice for users. 4. Where the Commission intends to make the implementation of certain standards or specifications compulsory, it shall publish a notice in the Official Journal of the European Union and invite public comment by all parties concerned. The Commission shall, by means of implementing acts, make implementation of the relevant standards compulsory by making reference to them as compulsory standards in the list of standards or specifications published in the Official Journal of the European Union. 5. Where the Commission considers that the standards or specifications referred to in paragraph 1 no longer contribute to the provision of harmonised electronic communications services, no longer meet consumers’ needs or hamper technological development, it shall remove them from the list of standards or specifications referred to in paragraph 1. 6. Where the Commission considers that the standards or specifications referred to in paragraph 4 no longer contribute to the provision of harmonised electronic communications services, no longer meet consumers’ needs, or hamper technological development, it shall, by means of implementing acts, remove those standards or specifications from the list of standards or specifications referred to in paragraph 1. 7. The implementing acts referred to in paragraphs 4 and 6 of this Article shall be adopted in accordance with the examination procedure referred to in Article 118(4). 8. This Article does not apply in respect of any of the essential requirements, interface specifications or harmonised standards to which Directive 2014/53/EU applies. TITLE V SECURITY Article 40 Security of networks and services 1. Member States shall ensure that providers of public electronic communications networks or of publicly available electronic communications services take appropriate and proportionate technical and organisational measures to appropriately manage the risks posed to the security of networks and services. Having regard to the state of the art, those measures shall ensure a level of security appropriate to the risk presented. In particular, measures, including encryption where appropriate, shall be taken to prevent and minimise the impact of security incidents on users and on other networks and services. The European Union Agency for Network and Information Security (‘ENISA’) shall facilitate, in accordance with Regulation (EU) No 526/2013 of the European Parliament and of the Council (45), the coordination of Member States to avoid diverging national requirements that may create security risks and barriers to the internal market. 2. Member States shall ensure that providers of public electronic communications networks or of publicly available electronic communications services notify without undue delay the competent authority of a security incident that has had a significant impact on the operation of networks or services. In order to determine the significance of the impact of a security incident, where available the following parameters shall, in particular, be taken into account: (a) the number of users affected by the security incident; (b) the duration of the security incident; (c) the geographical spread of the area affected by the security incident; (d) the extent to which the functioning of the network or service is affected; (e) the extent of impact on economic and societal activities. Where appropriate, the competent authority concerned shall inform the competent authorities in other Member States and ENISA. The competent authority concerned may inform the public or require the providers to do so, where it determines that disclosure of the security incident is in the public interest. Once a year, the competent authority concerned shall submit a summary report to the Commission and to ENISA on the notifications received and the action taken in accordance with this paragraph. 3. Member States shall ensure that in the case of a particular and significant threat of a security incident in public electronic communications networks or publicly available electronic communications services, providers of such networks or services shall inform their users potentially affected by such a threat of any possible protective measures or remedies which can be taken by the users. Where appropriate, providers shall also inform their users of the threat itself. 4. This Article is without prejudice to Regulation (EU) 2016/679 and Directive 2002/58/EC. 5. The Commission, taking utmost account of ENISA’s opinion, may adopt implementing acts detailing the technical and organisational measures referred to in paragraph 1, as well as the circumstances, format and procedures applicable to notification requirements pursuant to paragraph 2. They shall be based on European and international standards to the greatest extent possible, and shall not prevent Member States from adopting additional requirements in order to pursue the objectives set out in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 118(4). Article 41 Implementation and enforcement 1. Member States shall ensure that, in order to implement Article 40, the competent authorities have the power to issue binding instructions, including those regarding the measures required to remedy a security incident or prevent one from occurring when a significant threat has been identified and time-limits for implementation, to providers of public electronic communications networks or publicly available electronic communications services. 2. Member States shall ensure that competent authorities have the power to require providers of public electronic communications networks or publicly available electronic communications services to: (a) provide information needed to assess the security of their networks and services, including documented security policies; and (b) submit to a security audit carried out by a qualified independent body or a competent authority and make the results thereof available to the competent authority; the cost of the audit shall be paid by the provider. 3. Member States shall ensure that the competent authorities have all the powers necessary to investigate cases of non-compliance and the effects thereof on the security of the networks and services. 4. Member States shall ensure that, in order to implement Article 40, the competent authorities have the power to obtain the assistance of a Computer Security Incident Response Team (‘CSIRT’) designated pursuant to Article 9 of Directive (EU) 2016/1148 in relation to issues falling within the tasks of the CSIRTs pursuant to point 2 of Annex I to that Directive. 5. The competent authorities shall, where appropriate and in accordance with national law, consult and cooperate with the relevant national law enforcement authorities, the competent authorities within the meaning of Article 8(1) of Directive (EU) 2016/1148 and the national data protection authorities. PART II NETWORKS TITLE I MARKET ENTRY AND DEPLOYMENT CHAPTER I Fees Article 42 Fees for rights of use for radio spectrum and rights to install facilities 1. Member States may allow the competent authority to impose fees for the rights of use for radio spectrum or rights to install facilities on, over or under public or private property that are used for the provision of electronic communications networks or services and associated facilities which ensure the optimal use of those resources. Member States shall ensure that such fees are objectively justified, transparent, non-discriminatory and proportionate in relation to their intended purpose and shall take into account the general objectives of this Directive. 2. With respect to rights of use for radio spectrum, Member States shall seek to ensure that applicable fees are set at a level which ensures efficient assignment and use of radio spectrum, including by: (a) setting reserve prices as minimum fees for rights of use for radio spectrum by having regard to the value of those rights in their possible alternative uses; (b) taking into account costs entailed by conditions attached to those rights; and (c) applying, to the extent possible, payment arrangements linked to the actual availability for use of the radio spectrum. CHAPTER II Access to land Article 43 Rights of way 1. Member States shall ensure that, when a competent authority considers an application for the granting of rights: — to install facilities on, over or under public or private property to an undertaking authorised to provide public electronic communications networks, or — to install facilities on, over or under public property to an undertaking authorised to provide electronic communications networks other than to the public, that competent authority: (a) acts on the basis of simple, efficient, transparent and publicly available procedures, applied without discrimination and without delay, and in any event makes its decision within six months of the application, except in the case of expropriation; and (b) follows the principles of transparency and non-discrimination in attaching conditions to any such rights. The procedures referred to in points (a) and (b) may differ depending on whether the applicant is providing public electronic communications networks or not. 2. Member States shall ensure that, where public or local authorities retain ownership or control of undertakings providing public electronic communications networks or publicly available electronic communications services, there is an effective structural separation of the function responsible for granting the rights referred to in paragraph 1 from the activities associated with ownership or control. Article 44 Co-location and sharing of network elements and associated facilities for providers of electronic communications networks 1. Where an operator has exercised the right under national law to install facilities on, over or under public or private property, or has taken advantage of a procedure for the expropriation or use of property, competent authorities may impose co-location and sharing of the network elements and associated facilities installed on that basis, in order to protect the environment, public health, public security or to meet town- and country-planning objectives. Co-location or sharing of network elements and facilities installed and sharing of property may be imposed only after an appropriate period of public consultation, during which all interested parties shall be given an opportunity to express their views and only in the specific areas where such sharing is considered to be necessary with a view to pursuing the objectives provided in the first subparagraph. Competent authorities may impose the sharing of such facilities or property, including land, buildings, entries to buildings, building wiring, masts, antennae, towers and other supporting constructions, ducts, conduits, manholes, cabinets or measures facilitating the coordination of public works. Where necessary, a Member State may designate a national regulatory or other competent authority for one or more of the following tasks: (a) coordinating the process provided for in this Article; (b) acting as a single information point; (c) setting down rules for apportioning the costs of facility or property sharing and of civil works coordination. 2. Measures taken by a competent authority in accordance with this Article shall be objective, transparent, non-discriminatory, and proportionate. Where relevant, these measures shall be carried out in coordination with the national regulatory authorities. CHAPTER III Access to radio spectrum Section 1 Authorisations Article 45 Management of radio spectrum 1. Taking due account of the fact that radio spectrum is a public good that has an important social, cultural and economic value, Member States shall ensure the effective management of radio spectrum for electronic communications networks and services in their territory in accordance with Articles 3 and 4. They shall ensure that the allocation of, the issuing of general authorisations in respect of, and the granting of individual rights of use for radio spectrum for electronic communications networks and services by competent authorities are based on objective, transparent, pro-competitive, non-discriminatory and proportionate criteria. In applying this Article, Member States shall respect relevant international agreements, including the ITU Radio Regulations and other agreements adopted in the framework of the ITU applicable to radio spectrum, such as the agreement reached at the Regional Radiocommunications Conference of 2006, and may take public policy considerations into account. 2. Member States shall promote the harmonisation of use of radio spectrum by electronic communications networks and services across the Union, consistent with the need to ensure effective and efficient use thereof and in pursuit of benefits for the consumer such as competition, economies of scale and interoperability of networks and services. In so doing, they shall act in accordance with Article 4 of this Directive and with Decision No 676/2002/EC, inter alia, by: (a) pursuing wireless broadband coverage of their national territory and population at high quality and speed, as well as coverage of major national and European transport paths, including trans-European transport network as referred to in Regulation (EU) No 1315/2013 of the European Parliament and of the Council (46); (b) facilitating the rapid development in the Union of new wireless communications technologies and applications, including, where appropriate, in a cross-sectoral approach; (c) ensuring predictability and consistency in the granting, renewal, amendment, restriction and withdrawal of rights of use for radio spectrum in order to promote long-term investments; (d) ensuring the prevention of cross-border or national harmful interference in accordance with Articles 28 and 46 respectively, and taking appropriate pre-emptive and remedial measures to that end; (e) promoting the shared use of radio spectrum between similar or different uses of radio spectrum in accordance with competition law; (f) applying the most appropriate and least onerous authorisation system possible in accordance with Article 46 in such a way as to maximise flexibility, sharing and efficiency in the use of radio spectrum; (g) applying rules for the granting, transfer, renewal, modification and withdrawal of rights of use for radio spectrum that are clearly and transparently laid down in order to guarantee regulatory certainty, consistency and predictability; (h) pursuing consistency and predictability throughout the Union regarding the way the use of radio spectrum is authorised in protecting public health taking into account Recommendation 1999/519/EC. For the purpose of the first subparagraph, and in the context of the development of technical implementing measures for a radio spectrum band under Decision No 676/2002/EC, the Commission may request the RSPG to issue an opinion recommending the most appropriate authorisation regimes for the use of radio spectrum in that band or parts thereof. Where appropriate and taking utmost account of such opinion, the Commission may adopt a recommendation with a view to promoting a consistent approach in the Union with regard to the authorisation regimes for the use of that band. Where the Commission is considering the adoption of measures in accordance with Article 39(1), (4), (5) and (6), it may request the opinion of the RSPG with regard to the implications of any such standard or specification for the coordination, harmonisation and availability of radio spectrum. The Commission shall take utmost account of the RSPG’s opinion in taking any subsequent steps. 3. In the case of a national or regional lack of market demand for the use of a band in the harmonised radio spectrum, Member States may allow an alternative use of all or part of that band, including the existing use, in accordance with paragraphs 4 and 5 of this Article, provided that: (a) the finding of a lack of market demand for the use of such a band is based on a public consultation in accordance with Article 23, including a forward-looking assessment of market demand; (b) such alternative use does not prevent or hinder the availability or the use of such a band in other Member States; and (c) the Member State concerned takes due account of the long-term availability or use of such a band in the Union and the economies of scale for equipment resulting from using the harmonised radio spectrum in the Union. Any decision to allow alternative use on an exceptional basis shall be subject to a regular review and shall in any event be reviewed promptly upon a duly justified request by a prospective user to the competent authority for use of the band in accordance with the technical implementing measure. The Member State shall inform the Commission and the other Member States of the decision taken, together with the reasons therefor, as well as of the outcome of any review. 4. Without prejudice to the second subparagraph, Member States shall ensure that all types of technology used for the provision of electronic communications networks or services may be used in the radio spectrum declared available for electronic communications services in their National Frequency Allocation Plan in accordance with Union law. Member States may, however, provide for proportionate and non-discriminatory restrictions to the types of radio network or wireless access technology used for electronic communications services where this is necessary to: (a) avoid harmful interference; (b) protect public health against electromagnetic fields, taking utmost account of Recommendation 1999/519/EC; (c) ensure technical quality of service; (d) ensure maximisation of radio spectrum sharing; (e) safeguard efficient use of radio spectrum; or (f) ensure the fulfilment of a general interest objective in accordance with paragraph 5. 5. Without prejudice to the second subparagraph, Member States shall ensure that all types of electronic communications services may be provided in the radio spectrum declared available for electronic communications services in their National Frequency Allocation Plan in accordance with Union law. Member States may, however, provide for proportionate and non-discriminatory restrictions to the types of electronic communications services to be provided, including, where necessary, to fulfil a requirement under the ITU Radio Regulations. Measures that require an electronic communications service to be provided in a specific band available for electronic communications services shall be justified in order to ensure the fulfilment of a general interest objective as laid down by the Member States in accordance with Union law, including, but not limited to: (a) safety of life; (b) the promotion of social, regional or territorial cohesion; (c) the avoidance of inefficient use of radio spectrum; or (d) the promotion of cultural and linguistic diversity and media pluralism, for example the provision of radio and television broadcasting services. A measure which prohibits the provision of any other electronic communications service in a specific band may be provided for only where justified by the need to protect the safety of life services. Member States may, on an exceptional basis, also extend such a measure in order to fulfil other general interest objectives as laid down by the Member States in accordance with Union law. 6. Member States shall regularly review the necessity of the restrictions referred to in paragraphs 4 and 5, and shall make the results of those reviews public. 7. Restrictions established prior to 25 May 2011 shall comply with paragraphs 4 and 5 by 20 December 2018. Article 46 Authorisation of the use of radio spectrum 1. Member States shall facilitate the use of radio spectrum, including shared use, under general authorisations and limit the granting of individual rights of use for radio spectrum to situations where such rights are necessary to maximise efficient use in light of demand and taking into account the criteria set out in the second subparagraph. In all other cases, they shall set out the conditions for the use of radio spectrum in a general authorisation. To that end, Member States shall decide on the most appropriate regime for authorising the use of radio spectrum, taking account of: (a) the specific characteristics of the radio spectrum concerned; (b) the need to protect against harmful interference; (c) the development of reliable conditions for radio spectrum sharing, where appropriate; (d) the need to ensure technical quality of communications or service; (e) objectives of general interest as laid down by Member States in accordance with Union law; (f) the need to safeguard efficient use of radio spectrum. When considering whether to issue general authorisations or to grant individual rights of use for the harmonised radio spectrum, taking into account technical implementing measures adopted in accordance with Article 4 of Decision No 676/2002/EC, Member States shall seek to minimise problems of harmful interference, including in cases of shared use of radio spectrum on the basis of a combination of general authorisation and individual rights of use. Where appropriate, Member States shall consider the possibility to authorise the use of radio spectrum based on a combination of general authorisation and individual rights of use, taking into account the likely effects of different combinations of general authorisations and individual rights of use and of gradual transfers from one category to the other on competition, innovation and market entry. Member States shall seek to minimise restrictions on the use of radio spectrum by taking appropriate account of technological solutions for managing harmful interference in order to impose the least onerous authorisation regime possible. 2. When taking a decision pursuant to paragraph 1 with a view to facilitating the shared use of radio spectrum, the competent authorities shall ensure that the conditions for the shared use of radio spectrum are clearly set out. Such conditions shall facilitate efficient use of radio spectrum, competition and innovation. Article 47 Conditions attached to individual rights of use for radio spectrum 1. Competent authorities shall attach conditions to individual rights of use for radio spectrum in accordance with Article 13(1) in such a way as to ensure optimal and the most effective and efficient use of radio spectrum. They shall, before the assignment or renewal of such rights, clearly establish any such conditions, including the level of use required and the possibility to fulfil that requirement through trading or leasing, in order to ensure the implementation of those conditions in accordance with Article 30. Conditions attached to renewals of right of use for radio spectrum shall not provide undue advantages to existing holders of those rights. Such conditions shall specify the applicable parameters, including any deadline for exercising the rights of use, the non-fulfilment of which would entitle the competent authority to withdraw the right of use or impose other measures. Competent authorities shall, in a timely and transparent manner, consult and inform interested parties regarding conditions attached to individual rights of use before their imposition. They shall determine in advance and inform interested parties, in a transparent manner, of the criteria for the assessment of the fulfilment of those conditions. 2. When attaching conditions to individual rights of use for radio spectrum, competent authorities may, in particular with a view to ensuring effective and efficient use of radio spectrum or promoting coverage, provide for the following possibilities: (a) sharing passive or active infrastructure which relies on radio spectrum or radio spectrum; (b) commercial roaming access agreements; (c) joint roll-out of infrastructures for the provision of networks or services which rely on the use of radio spectrum. Competent authorities shall not prevent the sharing of radio spectrum in the conditions attached to the rights of use for radio spectrum. Implementation by undertakings of conditions attached pursuant to this paragraph shall remain subject to competition law. Section 2 Rights of use Article 48 Granting of individual rights of use for radio spectrum 1. Where it is necessary to grant individual rights of use for radio spectrum, Member States shall grant such rights, upon request, to any undertaking for the provision of electronic communications networks or services under the general authorisation referred to in Article 12, subject to Article 13, to point (c) of Article 21(1) and to Article 55 and to any other rules ensuring the efficient use of those resources in accordance with this Directive. 2. Without prejudice to specific criteria and procedures adopted by Member States to grant individual rights of use for radio spectrum to providers of radio or television broadcast content services with a view to pursuing general interest objectives in accordance with Union law, the individual rights of use for radio spectrum shall be granted through open, objective, transparent, non-discriminatory and proportionate procedures, and in accordance with Article 45. 3. An exception to the requirement of open procedures may apply where the granting of individual rights of use for radio spectrum to the providers of radio or television broadcast content services is necessary to achieve a general interest objective as laid down by Member States in accordance with Union law. 4. Competent authorities shall consider applications for individual rights of use for radio spectrum in the context of selection procedures pursuant to objective, transparent, proportionate and non-discriminatory eligibility criteria that are set out in advance and reflect the conditions to be attached to such rights. Competent authorities shall be able to request all necessary information from applicants in order to assess, on the basis of those criteria, their ability to comply with those conditions. Where the competent authority concludes that an applicant does not possess the required ability, it shall provide a duly reasoned decision to that effect. 5. When granting individual rights of use for radio spectrum, Member States shall specify whether those rights can be transferred or leased by the holder of the rights, and under which conditions. Articles 45 and 51 shall apply. 6. The competent authority shall take, communicate and make public the decisions on the granting of individual rights of use for radio spectrum as soon as possible after the receipt of the complete application and within six weeks in the case of radio spectrum declared available for electronic communications services in their National Frequency Allocation Plan. That time limit shall be without prejudice to Article 55(7) and to any applicable international agreements relating to the use of radio spectrum or of orbital positions. Article 49 Duration of rights 1. Where Member States authorise the use of radio spectrum through individual rights of use for a limited period, they shall ensure that the right of use is granted for a period that is appropriate in light of the objectives pursued in accordance with Article 55(2), taking due account of the need to ensure competition, as well as, in particular, effective and efficient use of radio spectrum, and to promote innovation and efficient investments, including by allowing for an appropriate period for investment amortisation. 2. Where Member States grant individual rights of use for radio spectrum for which harmonised conditions have been set by technical implementing measures in accordance with Decision No 676/2002/EC in order to enable its use for wireless broadband electronic communications services (‘wireless broadband services’) for a limited period, they shall ensure regulatory predictability for the holders of the rights over a period of at least 20 years regarding conditions for investment in infrastructure which relies on the use of such radio spectrum, taking account of the requirements referred to in paragraph 1 of this Article. This Article is subject, where relevant, to any modification of the conditions attached to those rights of use in accordance with Article 18. To that end, Member States shall ensure that such rights are valid for a duration of at least 15 years and include, where necessary to comply with the first subparagraph, an adequate extension thereof, under the conditions laid down in this paragraph. Member States shall make available the general criteria for an extension of the duration of rights of use, in a transparent manner, to all interested parties in advance of granting rights of use, as part of the conditions laid down under Article 55(3) and (6). Such general criteria shall relate to: (a) the need to ensure the effective and efficient use of the radio spectrum concerned, the objectives pursued in points (a) and (b) of Article 45(2), or the need to fulfil general interest objectives related to ensuring safety of life, public order, public security or defence; and (b) the need to ensure undistorted competition. At the latest two years before the expiry of the initial duration of an individual right of use, the competent authority shall conduct an objective and forward-looking assessment of the general criteria laid down for extension of the duration of that right of use in light of point (c) of Article 45(2). Provided that the competent authority has not initiated enforcement action for non-compliance with the conditions of the rights of use pursuant to Article 30, it shall grant the extension of the duration of the right of use unless it concludes that such an extension would not comply with the general criteria laid down in point (a) or (b) of the third subparagraph of this paragraph. On the basis of that assessment, the competent authority shall notify the holder of the right as to whether the extension of the duration of the right of use is to be granted. If such extension is not to be granted, the competent authority shall apply Article 48 for granting rights of use for that specific radio spectrum band. Any measure under this paragraph shall be proportionate, non-discriminatory, transparent and reasoned. By way of derogation from Article 23, interested parties shall have the opportunity to comment on any draft measure pursuant to the third and the fourth subparagraphs of this paragraph for a period of at least three months. This paragraph is without prejudice to the application of Articles 19 and 30. When establishing fees for rights of use, Member States shall take account of the mechanism provided for under this paragraph. 3. Where duly justified, Member States may derogate from paragraph 2 of this Article in the following cases: (a) in limited geographical areas, where access to high-speed networks is severely deficient or absent and this is necessary to ensure achievement of the objectives of Article 45(2); (b) for specific short-term projects; (c) for experimental use; (d) for uses of radio spectrum which, in accordance with Article 45(4) and (5), can coexist with wireless broadband services; or (e) for alternative use of radio spectrum in accordance with Article 45(3). 4. Member States may adjust the duration of rights of use laid down in this Article to ensure the simultaneous expiry of the duration of rights in one or several bands. Article 50 Renewal of individual rights of use for harmonised radio spectrum 1. National regulatory or other competent authorities shall take a decision on the renewal of individual rights of use for harmonised radio spectrum in a timely manner before the duration of those rights expired, except where, at the time of assignment, the possibility of renewal has been explicitly excluded. For that purpose, those authorities shall assess the need for such renewal at their own initiative or upon request by the holder of the right, in the latter case not earlier than five years prior to expiry of the duration of the rights concerned. This shall be without prejudice to renewal clauses applicable to existing rights. 2. In taking a decision pursuant to paragraph 1 of this Article, competent authorities shall consider, inter alia: (a) the fulfilment of the objectives set out in Article 3, Article 45(2) and Article 48(2), as well as public policy objectives under Union or national law; (b) the implementation of a technical implementing measure adopted in accordance with Article 4 of Decision No 676/2002/EC; (c) the review of the appropriate implementation of the conditions attached to the right concerned; (d) the need to promote, or avoid any distortion of, competition in line with Article 52; (e) the need to render the use of radio spectrum more efficient in light of technological or market evolution; (f) the need to avoid severe service disruption. 3. When considering possible renewal of individual rights of use for harmonised radio spectrum for which the number of rights of use is limited pursuant to paragraph 2 of this Article, competent authorities shall conduct an open, transparent and non-discriminatory procedure, and shall, inter alia: (a) give all interested parties the opportunity to express their views through a public consultation in accordance with Article 23; and (b) clearly state the reasons for such possible renewal. The national regulatory or other competent authority shall take into account any evidence arising from the consultation pursuant to the first subparagraph of this paragraph of market demand from undertakings other than those holding rights of use for radio spectrum in the band concerned when deciding whether to renew the rights of use or to organise a new selection procedure in order to grant the rights of use pursuant to Article 55. 4. A decision to renew the individual rights of use for harmonised radio spectrum may be accompanied by a review of the fees as well as of the other terms and conditions attached thereto. Where appropriate, national regulatory or other competent authorities may adjust the fees for the rights of use in accordance with Article 42. Article 51 Transfer or lease of individual rights of use for radio spectrum 1. Member States shall ensure that undertakings may transfer or lease to other undertakings individual rights of use for radio spectrum. Member States may determine that this paragraph does not apply where the undertaking’s individual right of use for radio spectrum was initially granted free of charge or assigned for broadcasting. 2. Member States shall ensure that an undertaking’s intention to transfer or lease rights of use for radio spectrum, as well as the effective transfer thereof is notified in accordance with national procedures to the competent authority and is made public. In the case of harmonised radio spectrum, any such transfer shall comply with such harmonised use. 3. Member States shall allow the transfer or lease of rights of use for radio spectrum where the original conditions attached to the rights of use are maintained. Without prejudice to the need to ensure the absence of a distortion of competition, in particular in accordance with Article 52, Member States shall: (a) submit transfers and leases to the least onerous procedure possible; (b) not refuse the lease of rights of use for radio spectrum where the lessor undertakes to remain liable for meeting the original conditions attached to the rights of use; (c) not refuse the transfer of rights of use for radio spectrum unless there is a clear risk that the new holder is unable to meet the original conditions for the right of use. Any administrative charge imposed on undertakings in connection with processing an application for the transfer or lease of rights of use for radio spectrum shall comply with Article 16. Points (a), (b) and (c) of the first subparagraph are without prejudice to the Member States’ competence to enforce compliance with the conditions attached to the rights of use at any time, both with regard to the lessor and the lessee, in accordance with their national law. Competent authorities shall facilitate the transfer or lease of rights of use for radio spectrum by giving consideration to any request to adapt the conditions attached to the rights in a timely manner and by ensuring that those rights or the relevant radio spectrum may to the best extent be partitioned or disaggregated. In light of any transfer or lease of rights of use for radio spectrum, competent authorities shall make relevant details relating to tradable individual rights publicly available in a standardised electronic format when the rights are created and keep those details for as long as the rights exist. The Commission may adopt implementing acts specifying those relevant details. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 118(4). Article 52 Competition 1. National regulatory and other competent authorities shall promote effective competition and avoid distortions of competition in the internal market when deciding to grant, amend or renew rights of use for radio spectrum for electronic communications networks and services in accordance with this Directive. 2. When Member States grant, amend or renew rights of use for radio spectrum, their national regulatory or other competent authorities upon the advice provided by national regulatory authority may take appropriate measures such as: (a) limiting the amount of radio spectrum bands for which rights of use are granted to any undertaking, or, in justified circumstances, attaching conditions to such rights of use, such as the provision of wholesale access, national or regional roaming, in certain bands or in certain groups of bands with similar characteristics; (b) reserving, if appropriate and justified with regard to a specific situation in the national market, a certain part of a radio spectrum band or group of bands for assignment to new entrants; (c) refusing to grant new rights of use for radio spectrum or to allow new radio spectrum uses in certain bands, or attaching conditions to the grant of new rights of use for radio spectrum or to the authorisation of new uses of radio spectrum, in order to avoid the distortion of competition by any assignment, transfer or accumulation of rights of use; (d) including conditions prohibiting, or imposing conditions on, transfers of rights of use for radio spectrum, not subject to Union or national merger control, where such transfers are likely to result in significant harm to competition; (e) amending the existing rights in accordance with this Directive where this is necessary to remedy ex post a distortion of competition by any transfer or accumulation of rights of use for radio spectrum. National regulatory and other competent authorities shall, taking into account market conditions and available benchmarks, base their decisions on an objective and forward-looking assessment of the market competitive conditions, of whether such measures are necessary to maintain or achieve effective competition, and of the likely effects of such measures on existing and future investments by market participants in particular for network roll-out. In doing so, they shall take into account the approach to market analysis as set out in Article 67(2). 3. When applying paragraph 2 of this Article, national regulatory and other competent authorities shall act in accordance with the procedures provided in Articles 18, 19, 23 and 35. Section 3 Procedures Article 53 Coordinated timing of assignments 1. Member States shall cooperate in order to coordinate the use of harmonised radio spectrum for electronic communications networks and services in the Union taking due account of the different national market situations. This may include identifying one, or, where appropriate, several common dates by which the use of specific harmonised radio spectrum is to be authorised. 2. Where harmonised conditions have been set by technical implementing measures in accordance with Decision No 676/2002/EC in order to enable the radio spectrum use for wireless broadband networks and services, Member States shall allow the use of that radio spectrum, as soon as possible and at the latest 30 months after the adoption of that measure, or as soon as possible after the lifting of any decision to allow alternative use on an exceptional basis pursuant to Article 45(3) of this Directive. This is without prejudice to Decision (EU) 2017/899 and to the Commission’s right of initiative to propose legislative acts. 3. A Member State may delay the deadline provided for in paragraph 2 of this Article for a specific band under the following circumstances: (a) to the extent justified by a restriction to the use of that band based on the general interest objective provided in point (a) or (d) of Article 45(5); (b) in the case of unresolved cross-border coordination issues resulting in harmful interference with third countries, provided the affected Member State has, where appropriate, requested Union assistance pursuant to Article 28(5); (c) safeguarding national security and defence; or (d) force majeure. The Member State concerned shall review such a delay at least every two years. 4. A Member State may delay the deadline provided for in paragraph 2 for a specific band to the extent necessary and up to 30 months in the case of: (a) unresolved cross-border coordination issues resulting in harmful interference between Member States, provided that the affected Member State takes all necessary measures in a timely manner pursuant to Article 28(3) and (4); (b) the need to ensure, and the complexity of ensuring, the technical migration of existing users of that band. 5. In the event of a delay under paragraph 3 or 4, the Member State concerned shall inform the other Member States and the Commission in a timely manner, stating the reasons. Article 54 Coordinated timing of assignments for specific 5G bands 1. By 31 December 2020, for terrestrial systems capable of providing wireless broadband services, Member States shall, where necessary in order to facilitate the roll-out of 5G, take all appropriate measures to: (a) reorganise and allow the use of sufficiently large blocks of the 3,4-3,8 GHz band; (b) allow the use of at least 1 GHz of the 24,25-27,5 GHz band, provided that there is clear evidence of market demand and of the absence of significant constraints for migration of existing users or band clearance. 2. Member States may, however, extend the deadline laid down in paragraph 1 of this Article, where justified, in accordance with Article 45(3) or Article 53(2), (3) or (4). 3. Measures taken pursuant paragraph 1 of this Article shall comply with the harmonised conditions set by technical implementing measures in accordance with Article 4 of Decision No 676/2002/EC. Article 55 Procedure for limiting the number of rights of use to be granted for radio spectrum 1. Without prejudice to Article 53, where a Member State concludes that a right to use radio spectrum cannot be subject to a general authorisation and where it considers whether to limit the number of rights of use to be granted for radio spectrum, it shall, inter alia: (a) clearly state the reasons for limiting the rights of use, in particular by giving due weight to the need to maximise benefits for users and to facilitate the development of competition, and review, as appropriate, the limitation at regular intervals or at the reasonable request of affected undertakings; (b) give all interested parties, including users and consumers, the opportunity to express their views on any limitation through a public consultation in accordance with Article 23. 2. When a Member State concludes that the number of rights of use is to be limited, it shall clearly establish, and give reasons for, the objectives pursued by means of a competitive or comparative selection procedure under this Article, and where possible quantify them, giving due weight to the need to fulfil national and internal market objectives. The objectives that the Member State may set out with a view to designing the specific selection procedure shall, in addition to promoting competition, be limited to one or more of the following: (a) promoting coverage; (b) ensuring the required quality of service; (c) promoting efficient use of radio spectrum, including by taking into account the conditions attached to the rights of use and the level of fees; (d) promoting innovation and business development. The national regulatory or other competent authority shall clearly define and justify the choice of the selection procedure, including any preliminary phase to access the selection procedure. It shall also clearly state the outcome of any related assessment of the competitive, technical and economic situation of the market and provide reasons for the possible use and choice of measures pursuant to Article 35. 3. Member States shall publish any decision on the selection procedure chosen and the related rules, clearly stating the reasons therefor. It shall also publish the conditions that are to be attached to the rights of use. 4. After having determined the selection procedure, the Member State shall invite applications for rights of use. 5. Where a Member State concludes that additional rights of use for radio spectrum or a combination of general authorisation and individual rights of use can be granted, it shall publish that conclusion and initiate the process of granting such rights. 6. Where the granting of rights of use for radio spectrum needs to be limited, Member States shall grant such rights on the basis of selection criteria and a selection procedure which are objective, transparent, non-discriminatory and proportionate. Any such selection criteria shall give due weight to the achievement of the objectives and requirements of Articles 3, 4, 28 and 45. 7. Where competitive or comparative selection procedures are to be used, Member States may extend the maximum period of six weeks referred to in Article 48(6) for as long as necessary to ensure that such procedures are fair, reasonable, open and transparent to all interested parties, but by no longer than eight months, subject to any specific timetable established pursuant to Article 53. Those time limits shall be without prejudice to any applicable international agreements relating to the use of radio spectrum and satellite coordination. 8. This Article is without prejudice to the transfer of rights of use for radio spectrum in accordance with Article 51. CHAPTER IV Deployment and use of wireless network equipment Article 56 Access to radio local area networks 1. Competent authorities shall allow the provision of access through RLANs to a public electronic communications network, as well as the use of the harmonised radio spectrum for that provision, subject only to applicable general authorisation conditions relating to radio spectrum use as referred to in Article 46(1). Where that provision is not part of an economic activity or is ancillary to an economic activity or a public service which is not dependent on the conveyance of signals on those networks, any undertaking, public authority or end-user providing such access shall not be subject to any general authorisation for the provision of electronic communications networks or services pursuant to Article 12, to obligations regarding end-users rights pursuant to Title II of Part III, or to obligations to interconnect their networks pursuant to Article 61(1). 2. Article 12 of Directive 2000/31/EC shall apply. 3. Competent authorities shall not prevent providers of public electronic communications networks or publicly available electronic communications services from allowing access to their networks to the public, through RLANs, which may be located at an end-user’s premises, subject to compliance with the applicable general authorisation conditions and the prior informed agreement of the end-user. 4. In accordance in particular with Article 3(1) of Regulation (EU) 2015/2120, competent authorities shall ensure that providers of public electronic communications networks or publicly available electronic communications services do not unilaterally restrict or prevent end-users from: (a) accessing RLANs of their choice provided by third parties; or (b) allowing reciprocally or, more generally, accessing the networks of such providers by other end-users through RLANs, including on the basis of third-party initiatives which aggregate and make publicly accessible the RLANs of different end-users. 5. Competent authorities shall not limit or prevent end-users from allowing access, reciprocally or otherwise, to their RLANs by other end-users, including on the basis of third-party initiatives which aggregate and make the RLANs of different end-users publicly accessible. 6. Competent authorities shall not unduly restrict the provision of access to RLANs to the public: (a) by public sector bodies or in public spaces close to premises occupied by such public sector bodies, when that provision is ancillary to the public services provided on those premises; (b) by initiatives of non-governmental organisations or public sector bodies to aggregate and make reciprocally or more generally accessible the RLANs of different end-users, including, where applicable, the RLANs to which public access is provided in accordance with point (a). Article 57 Deployment and operation of small-area wireless access points 1. Competent authorities shall not unduly restrict the deployment of small-area wireless access points. Member States shall seek to ensure that any rules governing the deployment of small-area wireless access points are nationally consistent. Such rules shall be published in advance of their application. In particular, competent authorities shall not subject the deployment of small-area wireless access points complying with the characteristics laid down pursuant to paragraph 2 to any individual town planning permit or other individual prior permits. By way of derogation from the second subparagraph of this paragraph, competent authorities may require permits for the deployment of small-area wireless access points on buildings or sites of architectural, historical or natural value protected in accordance with national law or where necessary for public safety reasons. Article 7 of Directive 2014/61/EU shall apply to the granting of those permits. 2. The Commission shall, by means of implementing acts, specify the physical and technical characteristics, such as maximum size, weight, and where appropriate emission power of small-area wireless access points. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 118(4). The first such implementing act shall be adopted by 30 June 2020. 3. This Article is without prejudice to the essential requirements laid down in Directive 2014/53/EU and to the authorisation regime applicable for the use of the relevant radio spectrum. 4. Member States shall, by applying, where relevant, the procedures adopted in accordance with Directive 2014/61/EU, ensure that operators have the right to access any physical infrastructure controlled by national, regional or local public authorities, which is technically suitable to host small-area wireless access points or which is necessary to connect such access points to a backbone network, including street furniture, such as light poles, street signs, traffic lights, billboards, bus and tramway stops and metro stations. Public authorities shall meet all reasonable requests for access on fair, reasonable, transparent and non-discriminatory terms and conditions, which shall be made public at a single information point. 5. Without prejudice to any commercial agreements, the deployment of small-area wireless access points shall not be subject to any fees or charges going beyond the administrative charges in accordance with Article 16. Article 58 Technical regulations on electromagnetic fields The procedures laid down in Directive (EU) 2015/1535 shall apply with respect to any draft measure by a Member State that would impose on the deployment of small-area wireless access points different requirements with respect to electromagnetic fields than those provided for in Recommendation 1999/519/EC. TITLE II ACCESS CHAPTER I General provisions, access principles Article 59 General framework for access and interconnection 1. Member States shall ensure that there are no restrictions which prevent undertakings in the same Member State or in different Member States from negotiating between themselves agreements on technical and commercial arrangements for access or interconnection, in accordance with Union law. The undertaking requesting access or interconnection does not need to be authorised to operate in the Member State where access or interconnection is requested, if it is not providing services and does not operate a network in that Member State. 2. Without prejudice to Article 114, Member States shall not maintain legal or administrative measures which require undertakings, when granting access or interconnection, to offer different terms and conditions to different undertakings for equivalent services or measures imposing obligations that are not related to the actual access and interconnection services provided without prejudice to the conditions set out in Annex I. Article 60 Rights and obligations of undertakings 1. Operators of public electronic communications networks shall have a right and, when requested by other undertakings so authorised in accordance with Article 15, an obligation to negotiate with each other interconnection for the purpose of providing publicly available electronic communications services, in order to ensure provision and interoperability of services throughout the Union. Operators shall offer access and interconnection to other undertakings on terms and conditions consistent with obligations imposed by the national regulatory authority pursuant to Articles 61, 62 and 68. 2. Without prejudice to Article 21, Member States shall require that undertakings which acquire information from another undertaking before, during or after the process of negotiating access or interconnection arrangements use that information solely for the purpose for which it was supplied and respect at all times the confidentiality of information transmitted or stored. Such undertakings shall not pass on the received information to any other party, in particular other departments, subsidiaries or partners, for whom such information could provide a competitive advantage. 3. Member States may provide for negotiations to be conducted through neutral intermediaries when conditions of competition so require. CHAPTER II Access and interconnection Article 61 Powers and responsibilities of the national regulatory and other competent authorities with regard to access and interconnection 1. National regulatory authorities or other competent authorities in the case of points (b) and (c) of the first subparagraph of paragraph 2 of this Article shall, acting in pursuit of the objectives set out in Article 3, encourage and, where appropriate, ensure, in accordance with this Directive, adequate access and interconnection, and the interoperability of services, exercising their responsibility in a way that promotes efficiency, sustainable competition, the deployment of very high capacity networks, efficient investment and innovation, and gives the maximum benefit to end-users. They shall provide guidance and make publicly available the procedures applicable to gain access and interconnection to ensure that small and medium-sized enterprises and operators with a limited geographical reach can benefit from the obligations imposed. 2. In particular, without prejudice to measures that may be taken regarding undertakings designated as having significant market power in accordance with Article 68, national regulatory authorities, or other competent authorities in the case of points (b) and (c) of this subparagraph, shall be able to impose: (a) to the extent necessary to ensure end-to-end connectivity, obligations on undertakings subject to general authorisation that control access to end-users, including, in justified cases, the obligation to interconnect their networks where this is not already the case; (b) in justified cases and to the extent necessary, obligations on undertakings subject to general authorisation that control access to end-users to make their services interoperable; (c) in justified cases, where end-to-end connectivity between end-users is endangered due to a lack of interoperability between interpersonal communications services, and to the extent necessary to ensure end-to-end connectivity between end-users, obligations on relevant providers of number-independent interpersonal communications services which reach a significant level of coverage and user uptake, to make their services interoperable; (d) to the extent necessary to ensure accessibility for end-users to digital radio and television broadcasting services and related complementary services specified by the Member State, obligations on operators to provide access to the other facilities referred to in Part II of Annex II on fair, reasonable and non-discriminatory terms. The obligations referred to in point (c) of the first subparagraph shall be imposed only: (i) to the extent necessary to ensure interoperability of interpersonal communications services and may include proportionate obligations on providers of those services to publish and allow the use, modification and redistribution of relevant information by the authorities and other providers, or to use and implement standards or specifications listed in Article 39(1) or of any other relevant European or international standards; (ii) where the Commission, after consulting BEREC and taking utmost account of its opinion, has found an appreciable threat to end-to-end connectivity between end-users throughout the Union or in at least three Member States and has adopted implementing measures specifying the nature and scope of any obligations that may be imposed. The implementing measures referred to in point (ii) of the second subparagraph shall be adopted in accordance with the examination procedure referred to in Article 118(4). 3. In particular, and without prejudice to paragraphs 1 and 2, national regulatory authorities may impose obligations, upon reasonable request, to grant access to wiring and cables and associated facilities inside buildings or up to the first concentration or distribution point as determined by the national regulatory authority, where that point is located outside the building. Where it is justified on the grounds that replication of such network elements would be economically inefficient or physically impracticable, such obligations may be imposed on providers of electronic communications networks or on the owners of such wiring and cables and associated facilities, where those owners are not providers of electronic communications networks. The access conditions imposed may include specific rules on access to such network elements and to associated facilities and associated services, on transparency and non-discrimination and on apportioning the costs of access, which, where appropriate, are adjusted to take into account risk factors. Where a national regulatory authority concludes, having regard, where applicable, to the obligations resulting from any relevant market analysis, that the obligations imposed in accordance with the first subparagraph do not sufficiently address high and non-transitory economic or physical barriers to replication which underlie an existing or emerging market situation significantly limiting competitive outcomes for end-users, it may extend the imposition of such access obligations, on fair and reasonable terms and conditions, beyond the first concentration or distribution point, to a point that it determines to be the closest to end-users, capable of hosting a sufficient number of end-user connections to be commercially viable for efficient access seekers. In determining the extent of the extension beyond the first concentration or distribution point, the national regulatory authority shall take utmost account of relevant BEREC guidelines. If justified on technical or economic grounds, national regulatory authorities may impose active or virtual access obligations. National regulatory authorities shall not impose obligations in accordance with the second subparagraph on providers of electronic communications networks where they determine that: (a) the provider has the characteristics listed in Article 80(1) and makes available a viable and similar alternative means of reaching end-users by providing access to a very high capacity network to any undertaking, on fair, non-discriminatory and reasonable terms and conditions; national regulatory authorities may extend that exemption to other providers offering, on fair, non-discriminatory and reasonable terms and conditions, access to a very high capacity network; or (b) the imposition of obligations would compromise the economic or financial viability of a new network deployment, in particular by small local projects. By way of derogation from point (a) of the third subparagraph, national regulatory authorities may impose obligations on providers of electronic communications networks fulfilling the criteria laid down in that point where the network concerned is publicly funded. By 21 December 2020, BEREC shall publish guidelines to foster a consistent application of this paragraph, by setting out the relevant criteria for determining: (a) the first concentration or distribution point; (b) the point, beyond the first concentration or distribution point, capable of hosting a sufficient number of end-user connections to enable an efficient undertaking to overcome the significant replicability barriers identified; (c) which network deployments can be considered to be new; (d) which projects can be considered to be small; and (e) which economic or physical barriers to replication are high and non-transitory. 4. Without prejudice to paragraphs 1 and 2, Member States shall ensure that competent authorities have the power to impose on undertakings providing or authorised to provide electronic communications networks obligations in relation to the sharing of passive infrastructure or obligations to conclude localised roaming access agreements, in both cases if directly necessary for the local provision of services which rely on the use of radio spectrum, in accordance with Union law and provided that no viable and similar alternative means of access to end-users is made available to any undertaking on fair and reasonable terms and conditions. Competent authorities may impose such obligations only where this possibility is clearly provided for when granting the rights of use for radio spectrum and where justified on the grounds that, in the area subject to such obligations, the market-driven deployment of infrastructure for the provision of networks or services which rely on the use of radio spectrum is subject to insurmountable economic or physical obstacles and therefore access to networks or services by end-users is severely deficient or absent. In those circumstances where access and sharing of passive infrastructure alone does not suffice to address the situation, national regulatory authorities may impose obligations on sharing of active infrastructure. Competent authorities shall have regard to: (a) the need to maximise connectivity throughout the Union, along major transport paths and in particular territorial areas, and to the possibility to significantly increase choice and higher quality of service for end-users; (b) the efficient use of radio spectrum; (c) the technical feasibility of sharing and associated conditions; (d) the state of infrastructure-based as well as service-based competition; (e) technological innovation; (f) the overriding need to support the incentive of the host to roll out the infrastructure in the first place. In the event of dispute resolution, competent authorities may, inter alia, impose on the beneficiary of the sharing or access obligation, the obligation to share radio spectrum with the infrastructure host in the relevant area. 5. Obligations and conditions imposed in accordance with paragraphs 1 to 4 of this Article shall be objective, transparent, proportionate and non-discriminatory, they shall be implemented in accordance with the procedures referred to in Articles 23, 32 and 33. The national regulatory and other competent authorities which have imposed such obligations and conditions shall assess the results thereof by five years after the adoption of the previous measure adopted in relation to the same undertakings and assess whether it would be appropriate to withdraw or amend them in light of evolving conditions. Those authorities shall notify the outcome of their assessment in accordance with the procedures referred to in Articles 23, 32 and 33. 6. For the purpose of paragraphs 1 and 2 of this Article, Member States shall ensure that the national regulatory authority is empowered to intervene on its own initiative where justified in order to secure the policy objectives of Article 3, in accordance with this Directive and, in particular, with the procedures referred to in Articles 23 and 32. 7. By 21 June 2020 in order to contribute to a consistent definition of the location of network termination points by national regulatory authorities, BEREC shall, after consulting stakeholders and in close cooperation with the Commission, adopt guidelines on common approaches to the identification of the network termination point in different network topologies. National regulatory authorities shall take utmost account of those guidelines when defining the location of network termination points. Article 62 Conditional access systems and other facilities 1. Member States shall ensure that the conditions laid down in Part I of Annex II apply in relation to conditional access to digital television and radio services broadcast to viewers and listeners in the Union, irrespective of the means of transmission. 2. Where, as a result of a market analysis carried out in accordance with Article 67(1), a national regulatory authority finds that one or more undertakings do not have significant market power on the relevant market, it may amend or withdraw the conditions with respect to those undertakings, in accordance with the procedures referred to in Articles 23 and 32, only to the extent that: (a) accessibility for end-users to radio and television broadcasts and broadcasting channels and services specified in accordance with Article 114 would not be adversely affected by such amendment or withdrawal; and (b) the prospects for effective competition in the following markets would not be adversely affected by such amendment or withdrawal: (i) retail digital television and radio broadcasting services; and (ii) conditional access systems and other associated facilities. An appropriate notice period shall be given to parties affected by such amendment or withdrawal of conditions. 3. Conditions applied in accordance with this Article are without prejudice to the ability of Member States to impose obligations in relation to the presentational aspect of EPGs and similar listing and navigation facilities. 4. Notwithstanding paragraph 1 of this Article, Member States may allow their national regulatory authority, as soon as possible after 20 December 2018 and periodically thereafter, to review the conditions applied in accordance with this Article, by undertaking a market analysis in accordance with Article 67(1) to determine whether to maintain, amend or withdraw the conditions applied. CHAPTER III Market analysis and significant market power Article 63 Undertakings with significant market power 1. Where this Directive requires national regulatory authorities to determine whether undertakings have significant market power in accordance with the procedure referred to in Article 67, paragraph 2 of this Article shall apply. 2. An undertaking shall be deemed to have significant market power if, either individually or jointly with others, it enjoys a position equivalent to dominance, namely a position of economic strength affording it the power to behave to an appreciable extent independently of competitors, customers and ultimately consumers. In particular, national regulatory authorities shall, when assessing whether two or more undertakings are in a joint dominant position in a market, act in accordance with Union law and take into the utmost account the guidelines on market analysis and the assessment of significant market power published by the Commission pursuant to Article 64. 3. Where an undertaking has significant market power on a specific market, it may also be designated as having significant market power on a closely related market, where the links between the two markets allow the market power held on the specific market to be leveraged into the closely related market, thereby strengthening the market power of the undertaking. Consequently, remedies aiming to prevent such leverage may be applied in the closely related market pursuant to Articles 69, 70, 71 and 74. Article 64 Procedure for the identification and definition of markets 1. After public consultation including with national regulatory authorities and taking the utmost account of the opinion of BEREC, the Commission shall adopt a Recommendation on Relevant Product and Service Markets (‘the Recommendation’). The Recommendation shall identify those product and service markets within the electronic communications sector the characteristics of which may be such as to justify the imposition of regulatory obligations set out in this Directive, without prejudice to markets that may be defined in specific cases under competition law. The Commission shall define markets in accordance with the principles of competition law. The Commission shall include product and service markets in the Recommendation where, after observing overall trends in the Union, it finds that each of the three criteria listed in Article 67(1) is met. The Commission shall review the Recommendation by 21 December 2020 and regularly thereafter. 2. After consulting BEREC, the Commission shall publish guidelines for market analysis and the assessment of significant market power (‘the SMP guidelines’) which shall be in accordance with the relevant principles of competition law. The SMP guidelines shall include guidance to national regulatory authorities on the application of the concept of significant market power to the specific context of ex ante regulation of electronic communications markets, taking account of the three criteria listed in Article 67(1). 3. National regulatory authorities shall, taking the utmost account of the Recommendation and the SMP guidelines, define relevant markets appropriate to national circumstances, in particular relevant geographic markets within their territory by taking into account, inter alia, the degree of infrastructure competition in those areas, in accordance with the principles of competition law. National regulatory authorities shall, where relevant, also take into account the results of the geographical survey conducted in accordance with Article 22(1). They shall follow the procedures referred to in Articles 23 and 32 before defining the markets that differ from those identified in the Recommendation. Article 65 Procedure for the identification of transnational markets 1. If the Commission or at least two national regulatory authorities concerned submit a reasoned request, including supporting evidence, BEREC shall conduct an analysis of a potential transnational market. After consulting stakeholders and taking utmost account of the analysis carried out by BEREC, the Commission may adopt decisions identifying transnational markets in accordance with the principles of competition law and taking utmost account of the Recommendation and SMP guidelines adopted in accordance with Article 64. 2. In the case of transnational markets identified in accordance with paragraph 1 of this Article, the national regulatory authorities concerned shall jointly conduct the market analysis taking the utmost account of the SMP guidelines and, in a concerted fashion, shall decide on any imposition, maintenance, amendment or withdrawal of regulatory obligations referred to in Article 67(4). The national regulatory authorities concerned shall jointly notify to the Commission their draft measures regarding the market analysis and any regulatory obligations pursuant to Articles 32 and 33. Two or more national regulatory authorities may also jointly notify their draft measures regarding the market analysis and any regulatory obligations in the absence of transnational markets, where they consider that market conditions in their respective jurisdictions are sufficiently homogeneous. Article 66 Procedure for the identification of transnational demand 1. BEREC shall conduct an analysis of transnational end-user demand for products and services that are provided within the Union in one or more of the markets listed in the Recommendation, if it receives a reasoned request providing supporting evidence from the Commission or from at least two of the national regulatory authorities concerned indicating that there is a serious demand problem to be addressed. BEREC may also conduct such analysis if it receives a reasoned request from market participants providing sufficient supporting evidence and considers that there is a serious demand problem to be addressed. BEREC’s analysis is without prejudice to any findings of transnational markets in accordance with Article 65(1) and to any findings of national or sub-national geographical markets by national regulatory authorities in accordance with Article 64(3). That analysis of transnational end-user demand may include products and services that are supplied within product or service markets that have been defined in different ways by one or more national regulatory authorities when taking into account national circumstances, provided that those products and services are substitutable to those supplied in one of the markets listed in the Recommendation. 2. If BEREC concludes that a transnational end-user demand exists, is significant and is not sufficiently met by supply provided on a commercial or regulated basis, it shall, after consulting stakeholders and in close cooperation with the Commission, issue guidelines on common approaches for national regulatory authorities to meet the identified transnational demand, including, where appropriate, when they impose remedies in accordance with Article 68. National regulatory authorities shall take into utmost account those guidelines when performing their regulatory tasks within their jurisdiction. Those guidelines may provide the basis for interoperability of wholesale access products across the Union and may include guidance for the harmonisation of technical specifications of wholesale access products capable of meeting such identified transnational demand. Article 67 Market analysis procedure 1. National regulatory authorities shall determine whether a relevant market defined in accordance with Article 64(3) is such as to justify the imposition of the regulatory obligations set out in this Directive. Member States shall ensure that an analysis is carried out, where appropriate, in collaboration with the national competition authorities. National regulatory authorities shall take utmost account of the SMP guidelines and shall follow the procedures referred to in Articles 23 and 32 when conducting such analysis. A market may be considered to justify the imposition of regulatory obligations set out in this Directive if all of the following criteria are met: (a) high and non-transitory structural, legal or regulatory barriers to entry are present; (b) there is a market structure which does not tend towards effective competition within the relevant time horizon, having regard to the state of infrastructure-based competition and other sources of competition behind the barriers to entry; (c) competition law alone is insufficient to adequately address the identified market failure(s). Where a national regulatory authority conducts an analysis of a market that is included in the Recommendation, it shall consider that points (a), (b) and (c) of the second subparagraph have been met, unless the national regulatory authority determines that one or more of such criteria is not met in the specific national circumstances. 2. Where a national regulatory authority conducts the analysis required by paragraph 1, it shall consider developments from a forward-looking perspective in the absence of regulation imposed on the basis of this Article in that relevant market, and taking into account all of the following: (a) market developments affecting the likelihood of the relevant market tending towards effective competition; (b) all relevant competitive constraints, at the wholesale and retail levels, irrespective of whether the sources of such constraints are considered to be electronic communications networks, electronic communications services, or other types of services or applications which are comparable from the perspective of the end-user, and irrespective of whether such constraints are part of the relevant market; (c) other types of regulation or measures imposed and affecting the relevant market or related retail market or markets throughout the relevant period, including, without limitation, obligations imposed in accordance with Articles 44, 60 and 61; (d) regulation imposed on other relevant markets on the basis of this Article. 3. Where a national regulatory authority concludes that a relevant market does not justify the imposition of regulatory obligations in accordance with the procedure in paragraphs 1 and 2 of this Article, or where the conditions set out in paragraph 4 of this Article are not met, it shall not impose or maintain any specific regulatory obligations in accordance with Article 68. Where there already are sector specific regulatory obligations imposed in accordance with Article 68, it shall withdraw such obligations placed on undertakings in that relevant market. National regulatory authorities shall ensure that parties affected by such a withdrawal of obligations receive an appropriate notice period, defined by balancing the need to ensure a sustainable transition for the beneficiaries of those obligations and end-users, end-user choice, and that regulation does not continue for longer than necessary. When setting such a notice period, national regulatory authorities may determine specific conditions and notice periods in relation to existing access agreements. 4. Where a national regulatory authority determines that, in a relevant market the imposition of regulatory obligations in accordance with paragraphs 1 and 2 of this Article is justified, it shall identify any undertakings which individually or jointly have a significant market power on that relevant market in accordance with Article 63. The national regulatory authority shall impose on such undertakings appropriate specific regulatory obligations in accordance with Article 68 or maintain or amend such obligations where they already exist if it considers that the outcome for end-users would not be effectively competitive in the absence of those obligations. 5. Measures taken in accordance with paragraphs 3 and 4 of this Article shall be subject to the procedures referred to in Articles 23 and 32. National regulatory authorities shall carry out an analysis of the relevant market and notify the corresponding draft measure in accordance with Article 32: (a) within five years from the adoption of a previous measure where the national regulatory authority has defined the relevant market and determined which undertakings have significant market power; that five-year period may, on an exceptional basis, be extended for up to one year, where the national regulatory authority has notified a reasoned proposal for an extension to the Commission no later than four months before the expiry of the five-year period, and the Commission has not objected within one month of the notified extension; (b) within three years from the adoption of a revised Recommendation on relevant markets, for markets not previously notified to the Commission; or (c) within three years from their accession, for Member States which have newly joined the Union. 6. Where a national regulatory authority considers that it may not complete or has not completed its analysis of a relevant market identified in the Recommendation within the time limit laid down in paragraph 5 of this Article, BEREC shall, upon request, provide assistance to the national regulatory authority concerned in completing the analysis of the specific market and the specific obligations to be imposed. With this assistance, the national regulatory authority concerned shall, within six months of the limit laid down in paragraph 5 of this Article, notify the draft measure to the Commission in accordance with Article 32. CHAPTER IV Access remedies imposed on undertakings with significant market power Article 68 Imposition, amendment or withdrawal of obligations 1. Member States shall ensure that national regulatory authorities are empowered to impose the obligations set out in Articles 69 to 74 and Articles 76 to 81. 2. Where an undertaking is designated as having significant market power on a specific market as a result of a market analysis carried out in accordance with Article 67, national regulatory authorities shall, as appropriate, impose any of the obligations set out in Articles 69 to 74 and Articles 76 and 80. In accordance with the principle of proportionality, a national regulatory authority shall choose the least intrusive way of addressing the problems identified in the market analysis. 3. National regulatory authorities shall impose the obligations set out in Articles 69 to 74 and Articles 76 and 80 only on undertakings that have been designated as having significant market power in accordance with paragraph 2 of this Article, without prejudice to: (a) Articles 61 and 62; (b) Articles 44 and 17 of this Directive, Condition 7 in Part D of Annex I as applied by virtue of Article 13(1) of this Directive, Articles 97 and 106 of this Directive and the relevant provisions of Directive 2002/58/EC containing obligations on undertakings other than those designated as having significant market power; or (c) the need to comply with international commitments. In exceptional circumstances, where a national regulatory authority intends to impose on undertakings designated as having significant market power obligations for access or interconnection other than those set out in Articles 69 to 74 and Articles 76 and 80, it shall submit a request to the Commission. The Commission shall, taking utmost account of the opinion of BEREC, adopt decisions by means of implementing acts, authorising or preventing the national regulatory authority from taking such measures. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 118(3). 4. Obligations imposed in accordance with this Article shall be: (a) based on the nature of the problem identified by a national regulatory authority in its market analysis, where appropriate taking into account the identification of transnational demand pursuant to Article 66; (b) proportionate, having regard, where possible, to the costs and benefits; (c) justified in light of the objectives laid down in Article 3; and (d) imposed following consultation in accordance with Articles 23 and 32. 5. In relation to the need to comply with international commitments referred to in paragraph 3 of this Article, national regulatory authorities shall notify decisions to impose, amend or withdraw obligations on undertakings to the Commission, in accordance with the procedure referred to in Article 32. 6. National regulatory authorities shall consider the impact of new market developments, such as in relation to commercial agreements, including co-investment agreements, influencing competitive dynamics. If those developments are not sufficiently important to require a new market analysis in accordance with Article 67, the national regulatory authority shall assess without delay whether it is necessary to review the obligations imposed on undertakings designated as having significant market power and amend any previous decision, including by withdrawing obligations or imposing new obligations, in order to ensure that such obligations continue to meet the conditions set out in paragraph 4 of this Article. Such amendments shall be imposed only after consultations in accordance with Articles 23 and 32. Article 69 Obligation of transparency 1. National regulatory authorities may, in accordance with Article 68, impose obligations of transparency in relation to interconnection or access, requiring undertakings to make public specific information, such as accounting information, prices, technical specifications, network characteristics and expected developments thereof, as well as terms and conditions for supply and use, including any conditions altering access to or use of services and applications, in particular with regard to migration from legacy infrastructure, where such conditions are allowed by Member States in accordance with Union law. 2. In particular, where an undertaking has obligations of non-discrimination, national regulatory authorities may require that undertaking to publish a reference offer, which shall be sufficiently unbundled to ensure that undertakings are not required to pay for facilities which are not necessary for the service requested. That offer shall contain a description of the relevant offerings broken down into components according to market needs, and the associated terms and conditions, including prices. The national regulatory authority may, inter alia, impose changes to reference offers to give effect to obligations imposed under this Directive. 3. National regulatory authorities may specify the precise information to be made available, the level of detail required and the manner of publication. 4. By 21 December 2019, in order to contribute to the consistent application of transparency obligations, BEREC shall, after consulting stakeholders and in close cooperation with the Commission, issue guidelines on the minimum criteria for a reference offer and shall review them where necessary in order to adapt them to technological and market developments. In providing such minimum criteria, BEREC shall pursue the objectives in Article 3, and shall have regard to the needs of the beneficiaries of access obligations and of end-users that are active in more than one Member State, as well as to any BEREC guidelines identifying transnational demand in accordance with Article 66 and to any related decision of the Commission. Notwithstanding paragraph 3 of this Article, where an undertaking has obligations under Article 72 or 73 concerning wholesale access to network infrastructure, national regulatory authorities shall ensure the publication of a reference offer taking utmost account of the BEREC guidelines on the minimum criteria for a reference offer, shall ensure that key performance indicators are specified, where relevant, as well as corresponding service levels, and closely monitor and ensure compliance with them. In addition, national regulatory authorities may, where necessary, predetermine the associated financial penalties in accordance with Union and national law. Article 70 Obligations of non-discrimination 1. A national regulatory authority may, in accordance with Article 68, impose obligations of non-discrimination, in relation to interconnection or access. 2. Obligations of non-discrimination shall ensure, in particular, that the undertaking applies equivalent conditions in equivalent circumstances to other providers of equivalent services, and provides services and information to others under the same conditions and of the same quality as it provides for its own services, or those of its subsidiaries or partners. National regulatory authorities may impose on that undertaking obligations to supply access products and services to all undertakings, including to itself, on the same timescales, terms and conditions, including those relating to price and service levels, and by means of the same systems and processes, in order to ensure equivalence of access. Article 71 Obligation of accounting separation 1. A national regulatory authority may, in accordance with Article 68, impose obligations for accounting separation in relation to specified activities related to interconnection or access. In particular, a national regulatory authority may require a vertically integrated undertaking to make transparent its wholesale prices and its internal transfer prices, inter alia to ensure compliance where there is an obligation of non-discrimination under Article 70 or, where necessary, to prevent unfair cross-subsidy. National regulatory authorities may specify the format and accounting methodology to be used. 2. Without prejudice to Article 20, to facilitate the verification of compliance with obligations of transparency and non-discrimination, national regulatory authorities shall have the power to require that accounting records, including data on revenues received from third parties, are provided on request. National regulatory authorities may publish information that would contribute to an open and competitive market, while complying with Union and national rules on commercial confidentiality. Article 72 Access to civil engineering 1. A national regulatory authority may, in accordance with Article 68, impose obligations on undertakings to meet reasonable requests for access to, and use of, civil engineering including, but not limited to, buildings or entries to buildings, building cables, including wiring, antennae, towers and other supporting constructions, poles, masts, ducts, conduits, inspection chambers, manholes, and cabinets, in situations where, having considered the market analysis, the national regulatory authority concludes that denial of access or access given under unreasonable terms and conditions having a similar effect would hinder the emergence of a sustainable competitive market and would not be in the end-user’s interest. 2. National regulatory authorities may impose obligations on an undertaking to provide access in accordance with this Article, irrespective of whether the assets that are affected by the obligation are part of the relevant market in accordance with the market analysis, provided that the obligation is necessary and proportionate to meet the objectives of Article 3. Article 73 Obligations of access to, and use of, specific network elements and associated facilities 1. National regulatory authorities may, in accordance with Article 68, impose obligations on undertakings to meet reasonable requests for access to, and use of, specific network elements and associated facilities, in situations where the national regulatory authorities consider that denial of access or unreasonable terms and conditions having a similar effect would hinder the emergence of a sustainable competitive market at the retail level, and would not be in the end-user’s interest. National regulatory authorities may require undertakings inter alia: (a) to give third parties access to, and use of, specific physical network elements and associated facilities, as appropriate, including unbundled access to the local loop and sub-loop; (b) to give third parties access to specific active or virtual network elements and services; (c) to negotiate in good faith with undertakings requesting access; (d) not to withdraw access to facilities already granted; (e) to provide specific services on a wholesale basis for resale by third parties; (f) to grant open access to technical interfaces, protocols or other key technologies that are indispensable for the interoperability of services or virtual network services; (g) to provide co-location or other forms of associated facilities sharing; (h) to provide specific services needed to ensure interoperability of end-to-end services to users, or roaming on mobile networks; (i) to provide access to operational support systems or similar software systems necessary to ensure fair competition in the provision of services; (j) to interconnect networks or network facilities; (k) to provide access to associated services such as identity, location and presence service. National regulatory authorities may subject those obligations to conditions covering fairness, reasonableness and timeliness. 2. Where national regulatory authorities consider the appropriateness of imposing any of the possible specific obligations referred to in paragraph 1 of this Article, and in particular where they assess, in accordance with the principle of proportionality, whether and how such obligations are to be imposed, they shall analyse whether other forms of access to wholesale inputs, either on the same or on a related wholesale market, would be sufficient to address the identified problem in the end-user’s interest. That assessment shall include commercial access offers, regulated access pursuant to Article 61, or existing or planned regulated access to other wholesale inputs pursuant to this Article. National regulatory authorities shall take account in particular of the following factors: (a) the technical and economic viability of using or installing competing facilities, in light of the rate of market development, taking into account the nature and type of interconnection or access involved, including the viability of other upstream access products, such as access to ducts; (b) the expected technological evolution affecting network design and management; (c) the need to ensure technology neutrality enabling the parties to design and manage their own networks; (d) the feasibility of providing the access offered, in relation to the capacity available; (e) the initial investment by the facility owner, taking account of any public investment made and the risks involved in making the investment, with particular regard to investments in, and risk levels associated with, very high capacity networks; (f) the need to safeguard competition in the long term, with particular attention to economically efficient infrastructure-based competition and innovative business models that support sustainable competition, such as those based on co-investment in networks; (g) where appropriate, any relevant intellectual property rights; (h) the provision of pan-European services. Where a national regulatory authority considers, in accordance with Article 68, imposing obligations on the basis of Articles 72 or of this Article, it shall examine whether the imposition of obligations in accordance with Article 72 alone would be a proportionate means by which to promote competition and the end-user's interest. 3. When imposing obligations on an undertaking to provide access in accordance with this Article, national regulatory authorities may lay down technical or operational conditions to be met by the provider or the beneficiaries of such access, where necessary to ensure normal operation of the network. Obligations to follow specific technical standards or specifications shall comply with the standards and specifications laid down in accordance with Article 39. Article 74 Price control and cost accounting obligations 1. A national regulatory authority may, in accordance with Article 68, impose obligations relating to cost recovery and price control, including obligations for cost orientation of prices and obligations concerning cost-accounting systems, for the provision of specific types of interconnection or access, in situations where a market analysis indicates that a lack of effective competition means that the undertaking concerned may sustain prices at an excessively high level, or may apply a price squeeze, to the detriment of end-users. In determining whether price control obligations would be appropriate, national regulatory authorities shall take into account the need to promote competition and long-term end-user interests related to the deployment and take-up of next-generation networks, and in particular of very high capacity networks. In particular, to encourage investments by the undertaking, including in next-generation networks, national regulatory authorities shall take into account the investment made by the undertaking. Where the national regulatory authorities consider price control obligations to be appropriate, they shall allow the undertaking a reasonable rate of return on adequate capital employed, taking into account any risks specific to a particular new investment network project. National regulatory authorities shall consider not imposing or maintaining obligations pursuant to this Article, where they establish that a demonstrable retail price constraint is present and that any obligations imposed in accordance with Articles 69 to 73, including, in particular, any economic replicability test imposed in accordance with Article 70, ensures effective and non-discriminatory access. When national regulatory authorities consider it appropriate to impose price control obligations on access to existing network elements, they shall also take account of the benefits of predictable and stable wholesale prices in ensuring efficient market entry and sufficient incentives for all undertakings to deploy new and enhanced networks. 2. National regulatory authorities shall ensure that any cost recovery mechanism or pricing methodology that is mandated serves to promote the deployment of new and enhanced networks, efficiency and sustainable competition and maximises sustainable end-user benefits. In this regard, national regulatory authorities may also take account of prices available in comparable competitive markets. 3. Where an undertaking has an obligation regarding the cost orientation of its prices, the burden of proof that charges are derived from costs, including a reasonable rate of return on investment, shall lie with the undertaking concerned. For the purpose of calculating the cost of efficient provision of services, national regulatory authorities may use cost accounting methods independent of those used by the undertaking. National regulatory authorities may require an undertaking to provide full justification for its prices, and may, where appropriate, require prices to be adjusted. 4. National regulatory authorities shall ensure that, where implementation of a cost-accounting system is mandated in order to support price control, a description of the cost-accounting system is made publicly available, showing at least the main categories under which costs are grouped and the rules used for the allocation of costs. A qualified independent body shall verify compliance with the cost-accounting system and shall publish annually a statement concerning compliance. Article 75 Termination rates 1. By 31 December 2020, the Commission shall, taking utmost account of the opinion of BEREC, adopt a delegated act in accordance with Article 117 supplementing this Directive by setting a single maximum Union-wide mobile voice termination rate and a single maximum Union-wide fixed voice termination rate (together referred to as ‘the Union-wide voice termination rates’), which are imposed on any provider of mobile voice termination or fixed voice termination services, respectively, in any Member State. To that end, the Commission shall: (a) comply with the principles, criteria and parameters provided in Annex III; (b) when setting the Union-wide voice termination rates for the first time, take into account the weighted average of efficient costs in fixed and mobile networks established in accordance with the principles provided in Annex III, applied across the Union; the Union-wide voice termination rates in the first delegated act shall not be higher than the highest rate among the rates that were in force six months before the adoption of that delegated act in all Member States, after any necessary adjustment for exceptional national circumstances; (c) take into account the total number of end-users in each Member State, in order to ensure a proper weighting of the maximum termination rates, as well as national circumstances which result in significant differences between Member States when determining the maximum termination rates in the Union; (d) take into account market information provided by BEREC, national regulatory authorities or, directly, by undertakings providing electronic communications networks and services; and (e) consider the need to allow for a transitional period of no longer than 12 months in order to allow adjustments in Member States where this is necessary on the basis of rates previously imposed. 2. Taking utmost account of the opinion of BEREC, the Commission shall review the delegated act adopted pursuant to this Article every five years and shall consider on each such occasion, by applying the criteria listed in Article 67(1), whether setting Union-wide voice termination rates continue to be necessary. Where the Commission decides, following its review in accordance with this paragraph, not to impose a maximum mobile voice termination rate or a maximum fixed voice termination rate, or neither, national regulatory authorities may conduct market analyses of voice termination markets in accordance with Article 67, to assess whether the imposition of regulatory obligations is necessary. If a national regulatory authority imposes, as a result of such analysis, cost-oriented termination rates in a relevant market, it shall follow the principles, criteria and parameters set out in Annex III and its draft measure shall be subject to the procedures referred to in Articles 23, 32 and 33. 3. National regulatory authorities shall closely monitor, and ensure compliance with, the application of the Union-wide voice termination rates by providers of voice termination services. National regulatory authorities may, at any time, require a provider of voice termination services to amend the rate it charges to other undertakings if it does not comply with the delegated act referred to in paragraph 1. National regulatory authorities shall annually report to the Commission and to BEREC with regard to the application of this Article. Article 76 Regulatory treatment of new very high capacity network elements 1. Undertakings which have been designated as having significant market power in one or several relevant markets in accordance with Article 67 may offer commitments, in accordance with the procedure set out in Article 79 and subject to the second subparagraph of this paragraph, to open the deployment of a new very high capacity network that consists of optical fibre elements up to the end-user premises or base station to co-investment, for example by offering co-ownership or long-term risk sharing through co-financing or through purchase agreements giving rise to specific rights of a structural character by other providers of electronic communications networks or services. When the national regulatory authority assesses those commitments, it shall determine, in particular, whether the offer to co-invest complies with all of the following conditions: (a) it is open at any moment during the lifetime of the network to any provider of electronic communications networks or services; (b) it would allow other co-investors which are providers of electronic communications networks or services to compete effectively and sustainably in the long term in downstream markets in which the undertaking designated as having significant market power is active, on terms which include: (i) fair, reasonable and non-discriminatory terms allowing access to the full capacity of the network to the extent that it is subject to co-investment; (ii) flexibility in terms of the value and timing of the participation of each co-investor; (iii) the possibility to increase such participation in the future; and (iv) reciprocal rights awarded by the co-investors after the deployment of the co-invested infrastructure; (c) it is made public by the undertaking in a timely manner and, if the undertaking does not have the characteristics listed in Article 80(1), at least six months before the start of the deployment of the new network; that period may be prolonged based on national circumstances; (d) access seekers not participating in the co-investment can benefit from the outset from the same quality, speed, conditions and end-user reach as were available before the deployment, accompanied by a mechanism of adaptation over time confirmed by the national regulatory authority in light of developments on the related retail markets, that maintains the incentives to participate in the co-investment; such mechanism shall ensure that access seekers have access to the very high capacity elements of the network at a time, and on the basis of transparent and non-discriminatory terms, which reflect appropriately the degrees of risk incurred by the respective co-investors at different stages of the deployment and take into account the competitive situation in retail markets; (e) it complies at a minimum with the criteria set out in Annex IV and is made in good faith. 2. If the national regulatory authority concludes, taking into account the results of the market test conducted in accordance with Article 79(2), that the co-investment commitment offered complies with the conditions set out in paragraph 1 of this Article, it shall make that commitment binding pursuant to Article 79(3), and shall not impose any additional obligations pursuant to Article 68 as regards the elements of the new very high capacity network that are subject to the commitments, if at least one potential co-investor has entered into a co-investment agreement with the undertaking designated as having significant market power. The first subparagraph shall be without prejudice to the regulatory treatment of circumstances that do not comply with the conditions set out in paragraph 1 of this Article, taking into account the results of any market test conducted in accordance with Article 79(2), but that have an impact on competition and are taken into account for the purposes of Articles 67 and 68. By way of derogation from the first subparagraph of this paragraph, a national regulatory authority may, in duly justified circumstances, impose, maintain or adapt remedies in accordance with Articles 68 to 74 as regards new very high capacity networks in order to address significant competition problems on specific markets, where the national regulatory authority establishes that, given the specific characteristics of these markets, those competition problems would not otherwise be addressed. 3. National regulatory authorities shall, on an ongoing basis, monitor compliance with the conditions set out in paragraph 1 and may require the undertaking designated as having significant market power to provide it with annual compliance statements. This Article shall be without prejudice to the power of a national regulatory authority to take decisions pursuant to Article 26(1) in the event of a dispute arising between undertakings in connection with a co-investment agreement considered by it to comply with the conditions set out in paragraph 1 of this Article. 4. BEREC, after consulting stakeholders and in close cooperation with the Commission, shall publish guidelines to foster the consistent application by national regulatory authorities of the conditions set out in paragraph 1, and the criteria set out in Annex IV. Article 77 Functional separation 1. Where the national regulatory authority concludes that the appropriate obligations imposed under Articles 69 to 74 have failed to achieve effective competition and that there are important and persisting competition problems or market failures identified in relation to the wholesale provision of certain access product markets, it may, on an exceptional basis, in accordance with the second subparagraph of Article 68(3), impose an obligation on vertically integrated undertakings to place activities related to the wholesale provision of relevant access products in a business entity operating independently. That business entity shall supply access products and services to all undertakings, including to other business entities within the parent company, on the same timescales, terms and conditions, including those relating to price and service levels, and by means of the same systems and processes. 2. When a national regulatory authority intends to impose an obligation of functional separation, it shall submit a request to the Commission that includes: (a) evidence justifying the conclusions of the national regulatory authority as referred to in paragraph 1; (b) a reasoned assessment concluding that there is no or little prospect of effective and sustainable infrastructure-based competition within a reasonable time-frame; (c) an analysis of the expected impact on the national regulatory authority, on the undertaking, in particular on the workforce of the separated undertaking, and on the electronic communications sector as a whole, and on incentives to invest therein, in particular with regard to the need to ensure social and territorial cohesion, and on other stakeholders including, in particular, the expected impact on competition and any potential resulting effects on consumers; (d) an analysis of the reasons justifying that this obligation would be the most efficient means to enforce remedies aimed at addressing the competition problems or the markets failures identified. 3. The draft measure shall include the following elements: (a) the precise nature and level of separation, specifying in particular the legal status of the separate business entity; (b) an identification of the assets of the separate business entity, and the products or services to be supplied by that entity; (c) the governance arrangements to ensure the independence of the staff employed by the separate business entity, and the corresponding incentive structure; (d) rules for ensuring compliance with the obligations; (e) rules for ensuring transparency of operational procedures, in particular towards other stakeholders; (f) a monitoring programme to ensure compliance, including the publication of an annual report. Following the Commission’s decision taken in accordance with Article 68(3) on that draft measure, the national regulatory authority shall conduct a coordinated analysis of the different markets related to the access network in accordance with the procedure set out in Article 67. On the basis of that analysis, the national regulatory authority shall impose, maintain, amend or withdraw obligations, in accordance with the procedures set out in Articles 23 and 32. 4. An undertaking on which functional separation has been imposed may be subject to any of the obligations referred to in Articles 69 to 74 in any specific market where it has been designated as having significant market power in accordance with Article 67, or any other obligations authorised by the Commission pursuant to Article 68(3). Article 78 Voluntary separation by a vertically integrated undertaking 1. Undertakings which have been designated as having significant market power in one or several relevant markets in accordance with Article 67 shall inform the national regulatory authority at least three months before any intended transfer of their local access network assets or a substantial part thereof to a separate legal entity under different ownership, or establishment of a separate business entity in order to provide all retail providers, including its own retail divisions, with fully equivalent access products. Those undertakings shall also inform the national regulatory authority of any change of that intent, as well as the final outcome of the process of separation. Such undertakings may also offer commitments regarding access conditions that are to apply to their network during an implementation period after the proposed form of separation is implemented, with a view to ensuring effective and non-discriminatory access by third parties. The offer of commitments shall include sufficient details, including in terms of timing of implementation and duration, in order to allow the national regulatory authority to conduct its tasks in accordance with paragraph 2 of this Article. Such commitments may extend beyond the maximum period for market reviews set out in Article 67(5). 2. The national regulatory authority shall assess the effect of the intended transaction, together with the commitments offered, where applicable, on existing regulatory obligations under this Directive. For that purpose, the national regulatory authority shall conduct an analysis of the different markets related to the access network in accordance with the procedure set out in Article 67. The national regulatory authority shall take into account any commitments offered by the undertaking, having regard in particular to the objectives set out in Article 3. In so doing, the national regulatory authority shall consult third parties in accordance with Article 23, and shall address, in particular, those third parties which are directly affected by the intended transaction. On the basis of its analysis, the national regulatory authority shall impose, maintain, amend or withdraw obligations, in accordance with the procedures set out in Articles 23 and 32, applying, if appropriate, Article 80. In its decision, the national regulatory authority may make the commitments binding, wholly or in part. By way of derogation from Article 67(5), the national regulatory authority may make the commitments binding, wholly or in part, for the entire period for which they are offered. 3. Without prejudice to Article 80, the legally or operationally separate business entity that has been designated as having significant market power in any specific market in accordance with Article 67 may be subject, as appropriate, to any of the obligations referred to in Articles 69 to 74 or any other obligations authorised by the Commission pursuant to Article 68(3), where any commitments offered are insufficient to meet the objectives set out in Article 3. 4. The national regulatory authority shall monitor the implementation of the commitments offered by the undertakings that it has made binding in accordance with paragraph 2 and shall consider their extension when the period for which they are initially offered has expired. Article 79 Commitments procedure 1. Undertakings designated as having significant market power may offer to the national regulatory authority commitments regarding conditions for access, co-investment, or both, applicable to their networks in relation, inter alia, to: (a) cooperative arrangements relevant to the assessment of appropriate and proportionate obligations pursuant to Article 68; (b) co-investment in very high capacity networks pursuant to Article 76; or (c) effective and non-discriminatory access by third parties pursuant to Article 78, both during an implementation period of voluntary separation by a vertically integrated undertaking and after the proposed form of separation is implemented. The offer for commitments shall be sufficiently detailed including as to the timing and scope of their implementation and their duration, to allow the national regulatory authority to undertake its assessment pursuant to paragraph 2 of this Article. Such commitments may extend beyond the periods for carrying out market analysis provided in Article 67(5). 2. In order to assess any commitments offered by an undertaking pursuant to paragraph 1 of this Article, the national regulatory authority shall, except where such commitments clearly do not fulfil one or more relevant conditions or criteria, perform a market test, in particular on the offered terms, by conducting a public consultation of interested parties, in particular third parties which are directly affected. Potential co-investors or access seekers may provide views on the compliance of the commitments offered with the conditions provided, as applicable, in Article 68, 76 or 78 and may propose changes. As regards the commitments offered under this Article, the national regulatory authority shall, when assessing obligations pursuant to Article 68(4), have particular regard to: (a) evidence regarding the fair and reasonable character of the commitments offered; (b) the openness of the commitments to all market participants; (c) the timely availability of access under fair, reasonable and non-discriminatory conditions, including to very high capacity networks, before the launch of related retail services; and (d) the overall adequacy of the commitments offered to enable sustainable competition on downstream markets and to facilitate cooperative deployment and take-up of very high capacity networks in the interest of end-users. Taking into account all the views expressed in the consultation, and the extent to which such views are representative of different stakeholders, the national regulatory authority shall communicate to the undertaking designated as having significant market power its preliminary conclusions whether the commitments offered comply with the objectives, criteria and procedures set out in this Article and, as applicable, in Article 68, 76 or 78, and under which conditions it may consider making the commitments binding. The undertaking may revise its initial offer to take account of the preliminary conclusions of the national regulatory authority and with a view to satisfying the criteria set out in this Article and, as applicable, in Article 68, 76 or 78. 3. Without prejudice to first subparagraph of Article 76(2), the national regulatory authority may issue a decision to make the commitments binding, wholly or in part. By way of derogation from Article 67(5), the national regulatory authority may make some or all commitments binding for a specific period, which may be the entire period for which they are offered, and in the case of co-investment commitments made binding pursuant to first subparagraph of Article 76(2), it shall make them binding for a period of minimum seven years. Subject to Article 76, this Article is without prejudice to the application of the market analysis procedure pursuant to Article 67 and the imposition of obligations pursuant to Article 68. Where the national regulatory authority makes commitments binding pursuant to this Article, it shall assess under Article 68 the consequences of that decision for market development and the appropriateness of any obligation that it has imposed or would, absent those commitments, have considered imposing pursuant to that Article or Articles 69 to 74. When notifying the relevant draft measure under Article 68 in accordance with Article 32, the national regulatory authority shall accompany the notified draft measure with the commitments decision. 4. The national regulatory authority shall monitor, supervise and ensure compliance with the commitments that it has made binding in accordance with paragraph 3 of this Article in the same way in which it monitors, supervises and ensures compliance with obligations imposed under Article 68 and shall consider the extension of the period for which they have been made binding when the initial period expires. If the national regulatory authority concludes that an undertaking has not complied with the commitments that have been made binding in accordance with paragraph 3 of this Article, it may impose penalties on such undertaking in accordance with Article 29. Without prejudice to the procedure for ensuring compliance of specific obligations under Article 30, the national regulatory authority may reassess the obligations imposed in accordance with Article 68(6). Article 80 Wholesale-only undertakings 1. A national regulatory authority that designates an undertaking which is absent from any retail markets for electronic communications services as having significant market power in one or several wholesale markets in accordance with Article 67 shall consider whether that undertaking has the following characteristics: (a) all companies and business units within the undertaking, all companies that are controlled but not necessarily wholly owned by the same ultimate owner, and any shareholder capable of exercising control over the undertaking, only have activities, current and planned for the future, in wholesale markets for electronic communications services and therefore do not have activities in any retail market for electronic communications services provided to end-users in the Union; (b) the undertaking is not bound to deal with a single and separate undertaking operating downstream that is active in any retail market for electronic communications services provided to end-users, because of an exclusive agreement, or an agreement which de facto amounts to an exclusive agreement. 2. If the national regulatory authority concludes that the conditions laid down in paragraph 1 of this Article are fulfilled, it may impose on that undertaking only obligations pursuant to Articles 70 and 73 or relative to fair and reasonable pricing if justified on the basis of a market analysis including a prospective assessment of the likely behaviour of the undertaking designated as having significant market power. 3. The national regulatory authority shall review obligations imposed on the undertaking in accordance with this Article at any time if it concludes that the conditions laid down in paragraph 1 of this Article are no longer met and it shall, as appropriate, apply Articles 67 to 74. The undertakings shall, without undue delay, inform the national regulatory authority of any change of circumstance relevant to points (a) and (b) of paragraph 1 of this Article. 4. The national regulatory authority shall also review obligations imposed on the undertaking in accordance with this Article if on the basis of evidence of terms and conditions offered by the undertaking to its downstream customers, the authority concludes that competition problems have arisen or are likely to arise to the detriment of end-users which require the imposition of one or more obligations provided in Article 69, 71, 72 or 74, or the amendment of the obligations imposed in accordance with paragraph 2 of this Article. 5. The imposition of obligations and their review in accordance with this Article shall be implemented in accordance with the procedures referred to in Articles 23, 32 and 33. Article 81 Migration from legacy infrastructure 1. Undertakings which have been designated as having significant market power in one or several relevant markets in accordance with Article 67 shall notify the national regulatory authority in advance and in a timely manner when they plan to decommission or replace with a new infrastructure parts of the network, including legacy infrastructure necessary to operate a copper network, which are subject to obligations pursuant to Articles 68 to 80. 2. The national regulatory authority shall ensure that the decommissioning or replacement process includes a transparent timetable and conditions, including an appropriate notice period for transition, and establishes the availability of alternative products of at least comparable quality providing access to the upgraded network infrastructure substituting the replaced elements if necessary to safeguard competition and the rights of end-users. With regard to assets which are proposed for decommissioning or replacement, the national regulatory authority may withdraw the obligations after having ascertained that the access provider: (a) has established the appropriate conditions for migration, including making available an alternative access product of at least comparable quality as was available using the legacy infrastructure enabling the access seekers to reach the same end-users; and (b) has complied with the conditions and process notified to the national regulatory authority in accordance with this Article. Such withdrawal shall be implemented in accordance with the procedures referred to in Articles 23, 32 and 33. 3. This Article shall be without prejudice to the availability of regulated products imposed by the national regulatory authority on the upgraded network infrastructure in accordance with the procedures set out in Articles 67 and 68. Article 82 BEREC guidelines on very high capacity networks By 21 December 2020, BEREC shall, after consulting stakeholders and in close cooperation with the Commission, issue guidelines on the criteria that a network is to fulfil in order to be considered a very high capacity network, in particular in terms of down- and uplink bandwidth, resilience, error-related parameters, and latency and its variation. The national regulatory authorities shall take those guidelines into utmost account. BEREC shall update the guidelines by 31 December 2025, and regularly thereafter. CHAPTER V Regulatory control of retail services Article 83 Regulatory control of retail services 1. Member States may ensure that national regulatory authorities impose appropriate regulatory obligations on undertakings identified as having significant market power on a given retail market in accordance with Article 63, where: (a) as a result of a market analysis carried out in accordance with Article 67, a national regulatory authority determines that a given retail market identified in accordance with Article 64 is not effectively competitive; and (b) the national regulatory authority concludes that obligations imposed under Articles 69 to 74 would not result in the achievement of the objectives set out in Article 3. 2. Obligations imposed under paragraph 1 of this Article shall be based on the nature of the problem identified and be proportionate and justified in light of the objectives laid down in Article 3. The obligations imposed may include requirements that the identified undertakings do not charge excessive prices, inhibit market entry or restrict competition by setting predatory prices, show undue preference to specific end-users or unreasonably bundle services. National regulatory authorities may apply to such undertakings appropriate retail price cap measures, measures to control individual tariffs, or measures to orient tariffs towards costs or prices on comparable markets, in order to protect end-user interests whilst promoting effective competition. 3. National regulatory authorities shall ensure that, where an undertaking is subject to retail tariff regulation or other relevant retail controls, the necessary and appropriate cost-accounting systems are implemented. National regulatory authorities may specify the format and accounting methodology to be used. Compliance with the cost-accounting system shall be verified by a qualified independent body. National regulatory authorities shall ensure that a statement concerning compliance is published annually. 4. Without prejudice to Articles 85 and 88, national regulatory authorities shall not apply retail control mechanisms under paragraph 1 of this Article to geographical or retail markets where they are satisfied that there is effective competition. PART III SERVICES TITLE I UNIVERSAL SERVICE OBLIGATIONS Article 84 Affordable universal service 1. Member States shall ensure that all consumers in their territories have access at an affordable price, in light of specific national conditions, to an available adequate broadband internet access service and to voice communications services at the quality specified in their territories, including the underlying connection, at a fixed location. 2. In addition, Member States may also ensure the affordability of the services referred to in paragraph 1 that are not provided at a fixed location where they consider this to be necessary to ensure consumers’ full social and economic participation in society. 3. Each Member State shall, in light of national conditions and the minimum bandwidth enjoyed by the majority of consumers within the territory of that Member State, and taking into account the BEREC report on best practices, define the adequate broadband internet access service for the purposes of paragraph 1 with a view to ensuring the bandwidth necessary for social and economic participation in society. The adequate broadband internet access service shall be capable of delivering the bandwidth necessary for supporting at least the minimum set of services set out in Annex V. By 21 June 2020, BEREC shall, in order to contribute towards a consistent application of this Article, after consulting stakeholders and in close cooperation with the Commission, taking into account available Commission (Eurostat) data, draw up a report on Member States’ best practices to support the defining of adequate broadband internet access service pursuant to the first subparagraph. That report shall be updated regularly to reflect technological advances and changes in consumer usage patterns. 4. When a consumer so requests, the connection referred to in paragraph 1 and, where applicable, in paragraph 2 may be limited to support voice communications services. 5. Member States may extend the scope of application of this Article to end-users that are microenterprises and small and medium-sized enterprises and not-for-profit organisations. Article 85 Provision of affordable universal service 1. National regulatory authorities in coordination with other competent authorities shall monitor the evolution and level of retail prices of the services referred to in Article 84(1) available on the market, in particular in relation to national prices and national consumer income. 2. Where Member States establish that, in light of national conditions, retail prices for the services referred to in Article 84(1) are not affordable, because consumers with a low income or special social needs are prevented from accessing such services, they shall take measures to ensure affordability for such consumers of adequate broadband internet access service and voice communications services at least at a fixed location. To that end, Member States may ensure that support is provided to such consumers for communication purposes or require providers of such services to offer to those consumers tariff options or packages different from those provided under normal commercial conditions, or both. For that purpose, Member States may require such providers to apply common tariffs, including geographic averaging, throughout the territory. In exceptional circumstances, in particular where the imposition of obligations under the second subparagraph of this paragraph on all providers would result in a demonstrated excessive administrative or financial burden for providers or the Member State, a Member State may, on an exceptional basis, decide to impose the obligation to offer those specific tariff options or packages only on designated undertakings. Article 86 shall apply to such designations mutatis mutandis. Where a Member State designates undertakings, it shall ensure that all consumers with a low-income or special social needs benefit from a choice of undertakings offering tariff options addressing their needs, unless ensuring such choice is impossible or would create an excessive additional organisational or financial burden. Member States shall ensure that consumers entitled to such tariff options or packages have a right to conclude a contract either with a provider of the services referred to in Article 84(1), or with an undertaking designated in accordance with this paragraph, and that their number remains available to them for an adequate period and unwarranted disconnection of the service is avoided. 3. Member States shall ensure that undertakings which provide tariff options or packages to consumers with a low income or special social needs pursuant to paragraph 2 keep the national regulatory and other competent authorities informed of the details of such offers. National regulatory authorities in coordination with other competent authorities shall ensure that the conditions under which undertakings provide tariff options or packages pursuant to paragraph 2 are fully transparent and are published and applied in accordance with the principle of non-discrimination. National regulatory authorities in coordination with other competent authorities may require such tariff options or packages to be modified or withdrawn. 4. Member States shall ensure, in light of national conditions, that support is provided, as appropriate, to consumers with disabilities, and that other specific measures are taken, where appropriate, with a view to ensuring that related terminal equipment, and specific equipment and specific services that enhance equivalent access, including where necessary total conversation services and relay services, are available and affordable. 5. When applying this Article, Member States shall seek to minimise market distortions. 6. Member States may extend the scope of application of this Article to end-users that are microenterprises and small and medium-sized enterprises and not-for-profit organisations. Article 86 Availability of universal service 1. Where a Member State has established, taking into account the results, where available, of the geographical survey conducted in accordance with Article 22(1), and any additional evidence where necessary, that the availability at a fixed location of an adequate broadband internet access service as defined in accordance with Article 84(3) and of voice communications services cannot be ensured under normal commercial circumstances or through other potential public policy tools in its national territory or different parts thereof, it may impose appropriate universal service obligations to meet all reasonable requests by end-users for accessing those services in the relevant parts of its territory. 2. Member States shall determine the most efficient and appropriate approach for ensuring the availability at a fixed location of an adequate broadband internet access service as defined in accordance with Article 84(3) and of voice communications services, whilst respecting the principles of objectivity, transparency, non-discrimination and proportionality. Member States shall seek to minimise market distortions, in particular the provision of services at prices or subject to other terms and conditions which depart from normal commercial conditions, whilst safeguarding the public interest. 3. In particular, where Member States decide to impose obligations to ensure for end-users the availability at a fixed location of an adequate broadband internet access service as defined in accordance with Article 84(3) and of voice communications services, they may designate one or more undertakings to guarantee such availability throughout the national territory. Member States may designate different undertakings or sets of undertakings to provide an adequate broadband internet access service and voice communications services at a fixed location or to cover different parts of the national territory. 4. When Member States designate undertakings in part or all of the national territory to ensure availability of services in accordance with paragraph 3 of this Article, they shall use an efficient, objective, transparent and non-discriminatory designation mechanism, whereby no undertaking is a priori excluded from being designated. Such designation methods shall ensure that an adequate broadband internet access service and voice communications services at a fixed location are provided in a cost-effective manner and may be used as a means of determining the net cost of the universal service obligations in accordance with Article 89. 5. When an undertaking designated in accordance with paragraph 3 of this Article intends to dispose of a substantial part or all of its local access network assets to a separate legal entity under different ownership, it shall inform the national regulatory or other competent authority in advance and in a timely manner, in order to allow that authority to assess the effect of the intended transaction on the provision at a fixed location of an adequate broadband internet access service as defined in accordance with Article 84(3) and of voice communications services. The national regulatory or other competent authority may impose, amend or withdraw specific obligations in accordance with Article 13(2). Article 87 Status of the existing universal service Member States may continue to ensure the availability or affordability of other services than adequate broadband internet access service as defined in accordance with Article 84(3) and voice communications services at a fixed location that were in force on 20 December 2018, if the need for such services is established in light of national circumstances. When Member States designate undertakings in part or all of the national territory for the provision of those services, Article 86 shall apply. Financing of those obligations shall comply with Article 90. Member States shall review the obligations imposed pursuant to this Article by 21 December 2021, and every three years thereafter. Article 88 Control of expenditure 1. Member States shall ensure that, in providing facilities and services additional to those referred to in Article 84, providers of an adequate broadband internet access service and of voice communications services in accordance with Articles 84 to 87 establish terms and conditions in such a way that the end-user is not obliged to pay for facilities or services which are not necessary or not required for the service requested. 2. Member States shall ensure that the providers of an adequate broadband internet access service and of voice communications services referred to in Article 84 that provide services pursuant to Article 85 offer the specific facilities and services set out in Part A of Annex VI as applicable, in order that consumers can monitor and control expenditure. Member States shall ensure that such providers put in place a system to avoid unwarranted disconnection of voice communications services or of an adequate broadband internet access service with regard to consumers as referred to in Article 85, including an appropriate mechanism to check continued interest in using the service. Member States may extend the scope of application of this paragraph to end-users that are microenterprises and small and medium-sized enterprises and not-for-profit organisations. 3. Each Member State shall ensure that the competent authority is able to waive the requirements of paragraph 2 in all or part of its national territory if the competent authority is satisfied that the facility is widely available. Article 89 Cost of universal service obligations 1. Where national regulatory authorities consider that the provision of an adequate broadband internet access service as defined in accordance with Article 84(3) and of voice communications services as set out in Articles 84, 85 and 86 or the continuation of the existing universal service as set out in Article 87 may represent an unfair burden on providers of such services that request compensation, national regulatory authorities shall calculate the net costs of such provision. For that purpose, national regulatory authorities shall: (a) calculate the net cost of the universal service obligations, taking into account any market benefit which accrues to a provider of an adequate broadband internet access service as defined in accordance with Article 84(3) and voice communications services as set out in Articles 84, 85 and 86 or the continuation of the existing universal service as set out in Article 87, in accordance with Annex VII; or (b) make use of the net costs of providing universal service identified by a designation mechanism in accordance with Article 86(4). 2. The accounts and other information serving as the basis for the calculation of the net cost of universal service obligations under point (a) of the second subparagraph of paragraph 1 shall be audited or verified by the national regulatory authority or a body independent of the relevant parties and approved by the national regulatory authority. The results of the cost calculation and the conclusions of the audit shall be publicly available. Article 90 Financing of universal service obligations 1. Where, on the basis of the net cost calculation referred to in Article 89, national regulatory authorities find that a provider is subject to an unfair burden, Member States shall, upon request from the provider concerned, decide to do one or both of the following: (a) introduce a mechanism to compensate that provider for the determined net costs under transparent conditions from public funds; (b) share the net cost of universal service obligations between providers of electronic communications networks and services. 2. Where the net cost is shared in accordance with point (b) of paragraph 1 of this Article, Member States shall establish a sharing mechanism administered by the national regulatory authority or a body independent from the beneficiaries under the supervision of the national regulatory authority. Only the net cost, as determined in accordance with Article 89, of the obligations laid down in Articles 84 to 87 may be financed. The sharing mechanism shall respect the principles of transparency, least market distortion, non-discrimination and proportionality, in accordance with the principles set out in Part B of Annex VII. Member States may choose not to require contributions from undertakings the national turnover of which is less than a set limit. Any charges related to the sharing of the cost of universal service obligations shall be unbundled and identified separately for each undertaking. Such charges shall not be imposed on, or collected from, undertakings that are not providing services in the territory of the Member State that has established the sharing mechanism. Article 91 Transparency 1. Where the net cost of universal service obligations is to be calculated in accordance with Article 89, national regulatory authorities shall ensure that the principles for net cost calculation, including the details of methodology to be used are publicly available. Where a mechanism for sharing the net cost of universal service obligations as referred to in Article 90(2) is established, national regulatory authorities shall ensure that the principles for cost sharing and compensation of the net cost are publicly available. 2. Subject to Union and national rules on commercial confidentiality, national regulatory authorities shall publish an annual report providing the details of calculated cost of universal service obligations, identifying the contributions made by all undertakings involved, including any market benefits that may have accrued to the undertakings pursuant to universal service obligations laid down in Articles 84 to 87. Article 92 Additional mandatory services Member States may decide to make services additional to those included in the universal service obligations referred to in Articles 84 to 87, publicly available on their territories. In such cases, no compensation mechanism involving specific undertakings shall be imposed. TITLE II NUMBERING RESOURCES Article 93 Numbering resources 1. Member States shall ensure that national regulatory or other competent authorities control the granting of rights of use for all national numbering resources and the management of the national numbering plans and that they provide adequate numbering resources for the provision of publicly available electronic communications services. Member States shall ensure that objective, transparent and non-discriminatory procedures for granting rights of use for national numbering resources are established. 2. National regulatory or other competent authorities may also grant rights of use for numbering resources from the national numbering plans for the provision of specific services to undertakings other than providers of electronic communications networks or services, provided that adequate numbering resources are made available to satisfy current and foreseeable future demand. Those undertakings shall demonstrate their ability to manage the numbering resources and to comply with any relevant requirements set out pursuant to Article 94. National regulatory or other competent authorities may suspend the further granting of rights of use for numbering resources to such undertakings if it is demonstrated that there is a risk of exhaustion of numbering resources. By 21 June 2020, in order to contribute to the consistent application of this paragraph, BEREC shall adopt, after consulting stakeholders and in close cooperation with the Commission, guidelines on common criteria for the assessment of the ability to manage numbering resources and of the risk of exhaustion of numbering resources. 3. National regulatory or other competent authorities shall ensure that national numbering plans and procedures are applied in a manner that gives equal treatment to all providers of publicly available electronic communications services and the undertakings eligible in accordance with paragraph 2. In particular, Member States shall ensure that an undertaking to which the right of use for numbering resources has been granted does not discriminate against other providers of electronic communications services as regards the numbering resources used to give access to their services. 4. Each Member State shall ensure that national regulatory or other competent authorities make available a range of non-geographic numbers which may be used for the provision of electronic communications services other than interpersonal communications services, throughout the territory of the Union, without prejudice to Regulation (EU) No 531/2012 and Article 97(2) of this Directive. Where rights of use for numbering resources have been granted in accordance with paragraph 2 of this Article to undertakings other than providers of electronic communications networks or services, this paragraph shall apply to the specific services for the provision of which the rights of use have been granted. National regulatory or other competent authorities shall ensure that the conditions listed in Part E of Annex I that may be attached to the rights of use for numbering resources used for the provision of services outside the Member State of the country code, and their enforcement, are as stringent as the conditions and enforcement applicable to services provided within the Member State of the country code, in accordance with this Directive. National regulatory or other competent authorities shall also ensure in accordance with Article 94(6) that providers using numbering resources of their country code in other Member States comply with consumer protection and other national rules related to the use of numbering resources applicable in those Member States where the numbering resources are used. This obligation is without prejudice to the enforcement powers of the competent authorities of those Member States. BEREC shall assist national regulatory or other competent authorities, at their request, in coordinating their activities to ensure the efficient management of numbering resources with a right of extraterritorial use within the Union. In order to facilitate the monitoring by the national regulatory or other competent authorities of compliance with the requirements of this paragraph, BEREC shall establish a database on the numbering resources with a right of extraterritorial use within the Union. For this purpose, national regulatory or other competent authorities shall transmit the relevant information to BEREC. Where numbering resources with a right of extraterritorial use within the Union are not granted by the national regulatory authority, the competent authority responsible for their granting or management shall consult the national regulatory authority. 5. Member States shall ensure that the ‘00’ code is the standard international access code. Special arrangements for the use of number-based interpersonal communications services between locations adjacent to one another across borders between Member States may be established or continued. Member States may agree to share a common numbering plan for all or specific categories of numbers. End-users affected by such arrangements or agreements shall be fully informed. 6. Without prejudice to Article 106, Member States shall promote over-the-air provisioning, where technically feasible, to facilitate switching of providers of electronic communications networks or services by end-users, in particular providers and end-users of machine-to-machine services. 7. Member States shall ensure that the national numbering plans, and all subsequent additions or amendments thereto, are published, subject only to limitations imposed on the grounds of national security. 8. Member States shall support the harmonisation of specific numbers or numbering ranges within the Union where it promotes both the functioning of the internal market and the development of pan-European services. Where necessary to address unmet cross-border or pan-European demand for numbering resources, the Commission shall, taking utmost account of the opinion of BEREC, adopt implementing acts harmonising specific numbers or numbering ranges. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 118(4). Article 94 Procedure for granting of rights of use for numbering resources 1. Where it is necessary to grant individual rights of use for numbering resources, national regulatory or other competent authorities shall grant such rights, upon request, to any undertaking for the provision of electronic communications networks or services covered by a general authorisation referred to in Article 12, subject to Article 13 and to point (c) of Article 21(1) and to any other rules ensuring the efficient use of those numbering resources in accordance with this Directive. 2. The rights of use for numbering resources shall be granted through open, objective, transparent, non-discriminatory and proportionate procedures. When granting rights of use for numbering resources, national regulatory or other competent authorities shall specify whether those rights can be transferred by the holder of the rights, and under which conditions. Where national regulatory or other competent authorities grant rights of use for numbering resources for a limited period, the duration of that period shall be appropriate for the service concerned with a view to the objective pursued, taking due account of the need to allow for an appropriate period for investment amortisation. 3. National regulatory or other competent authorities shall take decisions on the granting of rights of use for numbering resources as soon as possible after receipt of the complete application and within three weeks in the case of numbering resources that have been allocated for specific purposes within the national numbering plan. Such decisions shall be made public. 4. Where national regulatory or other competent authorities have determined, after consulting interested parties in accordance with Article 23, that rights of use for numbering resources of exceptional economic value are to be granted through competitive or comparative selection procedures, national regulatory or other competent authorities may extend the three-week period referred to in paragraph 3 of this Article by up to a further three weeks. 5. National regulatory or other competent authorities shall not limit the number of individual rights of use to be granted, except where this is necessary to ensure the efficient use of numbering resources. 6. Where the rights of use for numbering resources include their extraterritorial use within the Union in accordance with Article 93(4), national regulatory or other competent authorities shall attach to those rights of use specific conditions in order to ensure compliance with all the relevant national consumer protection rules and national law related to the use of numbering resources applicable in the Member States where the numbering resources are used. Upon request from a national regulatory or other competent authority of a Member State where the numbering resources are used, demonstrating a breach of relevant consumer protection rules or national laws related to the use of numbering resources of that Member State, the national regulatory or other competent authorities of the Member State where the rights of use for the numbering resources have been granted shall enforce the conditions attached under the first subparagraph of this paragraph in accordance with Article 30, including, in serious cases, by withdrawing the rights of extraterritorial use for the numbering resources granted to the undertaking concerned. BEREC shall facilitate and coordinate the exchange of information between the competent authorities of the different Member States involved and ensure the appropriate coordination of work among them. 7. This Article shall also apply where national regulatory or other competent authorities grant rights of use for numbering resources to undertakings other than providers of electronic communications networks or services in accordance with Article 93(2). Article 95 Fees for rights of use for numbering resources Member States may allow national regulatory or other competent authorities to impose fees for the rights of use for numbering resources which reflect the need to ensure the optimal use of those resources. Member States shall ensure that such fees are objectively justified, transparent, non-discriminatory and proportionate in relation to their intended purpose and shall take into account the objectives set out in Article 3. Article 96 Missing children and child helpline hotlines 1. Member States shall ensure that end-users have access free of charge to a service operating a hotline to report cases of missing children. The hotline shall be available on the number ‘116000’. 2. Member States shall ensure that end-users with disabilities are able to access services provided under the number ‘116000’ to the greatest extent possible. Measures taken to facilitate access by end-users with disabilities to such services whilst travelling in other Member States shall be based on compliance with relevant standards or specifications laid down in accordance with Article 39. 3. Member States shall take appropriate measures to ensure that the authority or undertaking to which the number ‘116000’ has been assigned allocates the necessary resources to operate the hotline. 4. Member States and the Commission shall ensure that end-users are adequately informed of the existence and use of services provided under the numbers ‘116000’ and, where appropriate, ‘116111’. Article 97 Access to numbers and services 1. Member States shall ensure that, where economically feasible, except where a called end-user has chosen for commercial reasons to limit access by calling parties located in specific geographical areas, national regulatory or other competent authorities take all necessary steps to ensure that end-users are able to: (a) access and use services using non-geographic numbers within the Union; and (b) access all numbers provided in the Union, regardless of the technology and devices used by the operator, including those in the national numbering plans of Member States and Universal International Freephone Numbers (UIFN). 2. Member States shall ensure that national regulatory or other competent authorities are able to require providers of public electronic communications networks or publicly available electronic communications services to block, on a case-by-case basis, access to numbers or services where this is justified by reasons of fraud or misuse and to require that in such cases providers of electronic communications services withhold relevant interconnection or other service revenues. TITLE III END-USER RIGHTS Article 98 Exemption of certain microenterprises With the exception of Articles 99 and 100, this Title shall not apply to microenterprises providing number-independent interpersonal communications services unless they also provide other electronic communications services. Member States shall ensure that end-users are informed of an exemption under the first paragraph before concluding a contract with a microenterprise benefitting from such an exemption. Article 99 Non-discrimination Providers of electronic communications networks or services shall not apply any different requirements or general conditions of access to, or use of, networks or services to end-users, for reasons related to the end-user’s nationality, place of residence or place of establishment, unless such different treatment is objectively justified. Article 100 Fundamental rights safeguard 1. National measures regarding end-users’ access to, or use of, services and applications through electronic communications networks shall respect the Charter of Fundamental Rights of the Union (the ‘Charter’) and general principles of Union law. 2. Any measure regarding end-users’ access to, or use of, services and applications through electronic communications networks liable to limit the exercise of the rights or freedoms recognised by the Charter shall be imposed only if it is provided for by law and respects those rights or freedoms, is proportionate, necessary, and genuinely meets general interest objectives recognised by Union law or the need to protect the rights and freedoms of others in line with Article 52(1) of the Charter and with general principles of Union law, including the right to an effective remedy and to a fair trial. Accordingly, such measures shall be taken only with due respect for the principle of the presumption of innocence and the right to privacy. A prior, fair and impartial procedure shall be guaranteed, including the right to be heard of the person or persons concerned, subject to the need for appropriate conditions and procedural arrangements in duly substantiated cases of urgency in accordance with the Charter. Article 101 Level of harmonisation 1. Member States shall not maintain or introduce in their national law end-user protection provisions diverging from Articles 102 to 115, including more, or less, stringent provisions to ensure a different level of protection, unless otherwise provided for in this Title. 2. Until 21 December 2021, Member States may continue to apply more stringent national consumer protection provisions diverging from those laid down in Articles 102 to 115, provided that those provisions were in force on 20 December 2018 and any restrictions to the functioning of the internal market resulting therefrom are proportionate to the objective of consumer protection. Member States shall notify the Commission by 21 December 2019 of any national provisions to be applied on the basis of this paragraph. Article 102 Information requirements for contracts 1. Before a consumer is bound by a contract or any corresponding offer, providers of publicly available electronic communications services other than transmission services used for the provision of machine-to-machine services shall provide the information referred to in Articles 5 and 6 of Directive 2011/83/EU, and, in addition, the information listed in Annex VIII of this Directive to the extent that that information relates to a service they provide. The information shall be provided in a clear and comprehensible manner on a durable medium as defined in point (10) of Article 2 of Directive 2011/83/EU or, where provision on a durable medium is not feasible, in an easily downloadable document made available by the provider. The provider shall expressly draw the consumer’s attention to the availability of that document and the importance of downloading it for the purposes of documentation, future reference and unchanged reproduction. The information shall, upon request, be provided in an accessible format for end-users with disabilities in accordance with Union law harmonising accessibility requirements for products and services. 2. The information referred to in paragraphs 1, 3 and 5 shall also be provided to end-users that are microenterprises or small enterprises or not-for-profit organisations, unless they have explicitly agreed to waive all or parts of those provisions. 3. Providers of publicly available electronic communications services other than transmission services used for the provision of machine-to-machine services shall provide consumers with a concise and easily readable contract summary. That summary shall identify the main elements of the information requirements in accordance with paragraph 1. Those main elements shall include at least: (a) the name, address and contact information of the provider and, if different, the contact information for any complaint; (b) the main characteristics of each service provided; (c) the respective prices for activating the electronic communications service and for any recurring or consumption-related charges, where the service is provided for direct monetary payment; (d) the duration of the contract and the conditions for its renewal and termination; (e) the extent to which the products and services are designed for end-users with disabilities; (f) with respect to internet access services, a summary of the information required pursuant to points (d) and (e) of Article 4(1) of Regulation (EU) 2015/2120. By 21 December 2019, the Commission shall, after consulting BEREC, adopt implementing acts specifying a contract summary template to be used by the providers to fulfil their obligations under this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 118(4). Providers subject to the obligations under paragraph 1 shall duly complete that contract summary template with the required information and provide the contract summary free of charge to consumers, prior to the conclusion of the contract, including distance contracts. Where, for objective technical reasons, it is impossible to provide the contract summary at that moment, it shall be provided without undue delay thereafter, and the contract shall become effective when the consumer has confirmed his or her agreement after reception of the contract summary. 4. The information referred to in paragraphs 1 and 3 shall become an integral part of the contract and shall not be altered unless the contracting parties expressly agree otherwise. 5. Where internet access services or publicly available interpersonal communications services are billed on the basis of either time or volume consumption, their providers shall offer consumers the facility to monitor and control the usage of each of those services. This facility shall include access to timely information on the level of consumption of services included in a tariff plan. In particular, providers shall notify consumers before any consumption limit, as established by competent authorities in coordination, where relevant, with national regulatory authorities, included in their tariff plan, is reached and when a service included in their tariff plan is fully consumed. 6. Member States may maintain or introduce in their national law provisions requiring providers to provide additional information on the consumption level and temporarily prevent further use of the relevant service in excess of a financial or volume limit determined by the competent authority. 7. Member States shall remain free to maintain or introduce in their national law provisions relating to aspects not regulated by this Article, in particular in order to address newly emerging issues. Article 103 Transparency, comparison of offers and publication of information 1. Competent authorities in coordination, where relevant, with national regulatory authorities shall ensure that, where providers of internet access services or publicly available interpersonal communication services make the provision of those services subject to terms and conditions, the information referred to in Annex IX is published in a clear, comprehensive, machine-readable manner and in an accessible format for end-users with disabilities in accordance with Union law harmonising accessibility requirements for products and services, by all such providers, or by the competent authority itself in coordination, where relevant, with the national regulatory authority. Such information shall be updated regularly. Competent authorities in coordination, where relevant, with national regulatory authorities may specify additional requirements regarding the form in which such information is to be published. That information shall, on request, be supplied to the competent authority and, where relevant, to the national regulatory authority before its publication. 2. Competent authorities shall, in coordination, where relevant, with national regulatory authorities, ensure that end-users have access free of charge to at least one independent comparison tool which enables them to compare and evaluate different internet access services and publicly available number-based interpersonal communications services, and, where applicable, publicly available number-independent interpersonal communications services, with regard to: (a) prices and tariffs of services provided against recurring or consumption-based direct monetary payments; and (b) the quality of service performance, where minimum quality of service is offered or the undertaking is required to publish such information pursuant to Article 104. 3. The comparison tool referred to in paragraph 2 shall: (a) be operationally independent from the providers of such services, thereby ensuring that those providers are given equal treatment in search results; (b) clearly disclose the owners and operators of the comparison tool; (c) set out clear and objective criteria on which the comparison is to be based; (d) use plain and unambiguous language; (e) provide accurate and up-to-date information and state the time of the last update; (f) be open to any provider of internet access services or publicly available interpersonal communications services making available the relevant information, and include a broad range of offers covering a significant part of the market and, where the information presented is not a complete overview of the market, a clear statement to that effect, before displaying results; (g) provide an effective procedure to report incorrect information; (h) include the possibility to compare prices, tariffs and quality of service performance between offers available to consumers and, if required by Member States, between those offers and the standard offers publicly available to other end-users. Comparison tools fulfilling the requirements in points (a) to (h) shall, upon request by the provider of the tool, be certified by competent authorities in coordination, where relevant, with national regulatory authorities. Third parties shall have a right to use, free of charge and in open data formats, the information published by providers of internet access services or publicly available interpersonal communications services, for the purposes of making available such independent comparison tools. 4. Member States may require that providers of internet access services or publicly available number-based interpersonal communications services, or both, distribute public interest information free of charge to existing and new end-users, where appropriate, by the means that they ordinarily use in their communications with end-users. In such a case, that public interest information shall be provided by the relevant public authorities in a standardised format and shall, inter alia, cover the following topics: (a) the most common uses of internet access services and publicly available number-based interpersonal communications services to engage in unlawful activities or to disseminate harmful content, in particular where it may prejudice respect for the rights and freedoms of others, including infringements of data protection rights, copyright and related rights, and their legal consequences; and (b) the means of protection against risks to personal security, privacy and personal data when using internet access services and publicly available number-based interpersonal communications services. Article 104 Quality of service related to internet access services and publicly available interpersonal communications services 1. National regulatory authorities in coordination with other competent authorities may require providers of internet access services and of publicly available interpersonal communications services to publish comprehensive, comparable, reliable, user-friendly and up-to-date information for end-users on the quality of their services, to the extent that they control at least some elements of the network either directly or by virtue of a service level agreement to that effect, and on measures taken to ensure equivalence in access for end-users with disabilities. National regulatory authorities in coordination with other competent authorities may also require providers of publicly available interpersonal communication services to inform consumers if the quality of the services they provide depends on any external factors, such as control of signal transmission or network connectivity. That information shall, on request, be supplied to the national regulatory and, where relevant, to other competent authorities before its publication. The measures to ensure quality of service shall comply with Regulation (EU) 2015/2120. 2. National regulatory authorities in coordination with other competent authorities shall specify, taking utmost account of BEREC guidelines, the quality of service parameters to be measured, the applicable measurement methods, and the content, form and manner of the information to be published, including possible quality certification mechanisms. Where appropriate, the parameters, definitions and measurement methods set out in Annex X shall be used. By 21 June 2020, in order to contribute to a consistent application of this paragraph and of Annex X, BEREC shall, after consulting stakeholders and in close cooperation with the Commission, adopt guidelines detailing the relevant quality of service parameters, including parameters relevant for end-users with disabilities, the applicable measurement methods, the content and format of publication of the information, and quality certification mechanisms. Article 105 Contract duration and termination 1. Member States shall ensure that conditions and procedures for contract termination do not act as a disincentive to changing service provider and that contracts concluded between consumers and providers of publicly available electronic communications services other than number-independent interpersonal communications services and other than transmission services used for the provision of machine-to-machine services, do not mandate a commitment period longer than 24 months. Member States may adopt or maintain provisions which mandate shorter maximum contractual commitment periods. This paragraph shall not apply to the duration of an instalment contract where the consumer has agreed in a separate contract to instalment payments exclusively for deployment of a physical connection, in particular to very high capacity networks. An instalment contract for the deployment of a physical connection shall not include terminal equipment, such as a router or modem, and shall not preclude consumers from exercising their rights under this Article. 2. Paragraph 1 shall also apply to end-users that are microenterprises, small enterprises or not-for-profit organisations, unless they have explicitly agreed to waive those provisions. 3. Where a contract or national law provides for automatic prolongation of a fixed duration contract for electronic communications services other than number-independent interpersonal communications services and other than transmission services used for the provision of machine-to-machine services, Member States shall ensure that, after such prolongation, end-users are entitled to terminate the contract at any time with a maximum one-month notice period, as determined by Member States, and without incurring any costs except the charges for receiving the service during the notice period. Before the contract is automatically prolonged, providers shall inform end-users, in a prominent and timely manner and on a durable medium, of the end of the contractual commitment and of the means by which to terminate the contract. In addition, and at the same time, providers shall give end-users best tariff advice relating to their services. Providers shall provide end-users with best tariff information at least annually. 4. End-users shall have the right to terminate their contract without incurring any further costs upon notice of changes in the contractual conditions proposed by the provider of publicly available electronic communications services other than number-independent interpersonal communications services, unless the proposed changes are exclusively to the benefit of the end-user, are of a purely administrative nature and have no negative effect on the end-user, or are directly imposed by Union or national law. Providers shall notify end-users at least one month in advance of any change in the contractual conditions, and shall simultaneously inform them of their right to terminate the contract without incurring any further costs if they do not accept the new conditions. The right to terminate the contract shall be exercisable within one month after notification. Member States may extend that period by up to three months. Member States shall ensure that notification is made in a clear and comprehensible manner on a durable medium. 5. Any significant continued or frequently recurring discrepancy between the actual performance of an electronic communications service, other than an internet access service or a number-independent interpersonal communications service, and the performance indicated in the contract shall be considered to be a basis for triggering the remedies available to the consumer in accordance with national law, including the right to terminate the contract free of cost. 6. Where an end-user has the right to terminate a contract for a publicly available electronic communications service, other than a number-independent interpersonal communications service, before the end of the agreed contract period pursuant to this Directive or to other provisions of Union or national law, no compensation shall be due by the end-user other than for retained subsidised terminal equipment. Where the end-user chooses to retain terminal equipment bundled at the moment of the contract conclusion, any compensation due shall not exceed its pro rata temporis value as agreed at the moment of the conclusion of the contract or the remaining part of the service fee until the end of the contract, whichever is the smaller. Member States may determine other methods to calculate the compensation rate, provided that such methods do not result in a level of compensation exceeding that calculated in accordance with the second subparagraph. The provider shall lift any condition on the use of that terminal equipment on other networks free of charge at a time specified by Member States and at the latest upon payment of the compensation. 7. As far as transmission services used for machine-to-machine services are concerned, the rights mentioned in paragraphs 4 and 6 shall benefit only end-users that are consumers, microenterprises, small enterprises or not-for-profit organisations. Article 106 Provider switching and number portability 1. In the case of switching between providers of internet access services, the providers concerned shall provide the end-user with adequate information before and during the switching process and ensure continuity of the internet access service, unless technically not feasible. The receiving provider shall ensure that the activation of the internet access service occurs within the shortest possible time on the date and within the timeframe expressly agreed with the end-user. The transferring provider shall continue to provide its internet access service on the same terms until the receiving provider activates its internet access service. Loss of service during the switching process shall not exceed one working day. National regulatory authorities shall ensure the efficiency and simplicity of the switching process for the end-user. 2. Member States shall ensure that all end-users with numbers from the national numbering plan have the right to retain their numbers, upon request, independently of the undertaking providing the service, in accordance with Part C of Annex VI. 3. Where an end-user terminates a contract, Member States shall ensure that the end-user can retain the right to port a number from the national numbering plan to another provider for a minimum of one month after the date of termination, unless that right is renounced by the end-user. 4. National regulatory authorities shall ensure that pricing among providers related to the provision of number portability is cost-oriented, and that no direct charges are applied to end-users. 5. The porting of numbers and their subsequent activation shall be carried out within the shortest possible time on the date explicitly agreed with the end-user. In any case, end-users who have concluded an agreement to port a number to a new provider shall have that number activated within one working day from the date agreed with the end-user. In the case of failure of the porting process, the transferring provider shall reactivate the number and related services of the end-user until the porting is successful. The transferring provider shall continue to provide its services on the same terms and conditions until the services of the receiving provider are activated. In any event, the loss of service during the process of provider switching and the porting of numbers shall not exceed one working day. Operators whose access networks or facilities are used by either the transferring or the receiving provider, or both, shall ensure that there is no loss of service that would delay the switching and porting process. 6. The receiving provider shall lead the switching and porting processes set out in paragraphs 1 and 5 and both the receiving and transferring providers shall cooperate in good faith. They shall not delay or abuse the switching and porting processes, nor shall they port numbers or switch end-users without the end-users’ explicit consent. The end-users’ contracts with the transferring provider shall be terminated automatically upon conclusion of the switching process. National regulatory authorities may establish the details of the switching and porting processes, taking into account national provisions on contracts, technical feasibility and the need to maintain continuity of service to the end-users. This shall include, where technically feasible, a requirement for the porting to be completed through over-the-air provisioning, unless an end-user requests otherwise. National regulatory authorities shall also take appropriate measures ensuring that end-users are adequately informed and protected throughout the switching and porting processes and are not switched to another provider without their consent. Transferring providers shall refund, upon request, any remaining credit to the consumers using pre-paid services. Refund may be subject to a fee only if provided for in the contract. Any such fee shall be proportionate and commensurate with the actual costs incurred by the transferring provider in offering the refund. 7. Member States shall lay down rules on penalties in the case of the failure of a provider to comply with the obligations laid down in this Article, including delays in, or abuses of, porting by, or on behalf of, a provider. 8. Member States shall lay down rules on the compensation of end-users by their providers in an easy and timely manner in the case of the failure of a provider to comply with the obligations laid down in this Article, as well as in the case of delays in, or abuses of, porting and switching processes, and missed service and installation appointments. 9. In addition to the information required under Annex VIII, Member States shall ensure that end-users are adequately informed about the existence of the rights to compensation referred to in paragraphs 7 and 8. Article 107 Bundled offers 1. If a bundle of services or a bundle of services and terminal equipment offered to a consumer comprises at least an internet access service or a publicly available number-based interpersonal communications service, Article 102(3), Article 103(1), Article 105 and Article 106(1) shall apply to all elements of the bundle including, mutatis mutandis, those not otherwise covered by those provisions. 2. Where the consumer has, under Union law, or national law in accordance with Union law, a right to terminate any element of the bundle as referred to in paragraph 1 before the end of the agreed contract term because of a lack of conformity with the contract or a failure to supply, Member States shall provide that the consumer has the right to terminate the contract with respect to all elements of the bundle. 3. Any subscription to additional services or terminal equipment provided or distributed by the same provider of internet access services or of publicly available number-based interpersonal communications services shall not extend the original duration of the contract to which such services or terminal equipment are added, unless the consumer expressly agrees otherwise when subscribing to the additional services or terminal equipment. 4. Paragraphs 1 and 3 shall also apply to end-users that are microenterprises, small enterprises, or not-for-profit organisations, unless they have explicitly agreed to waive all or parts of those provisions. 5. Member States may also apply paragraph 1 as regards other provisions laid down in this Title. Article 108 Availability of services Member States shall take all necessary measures to ensure the fullest possible availability of voice communications services and internet access services provided over public electronic communications networks in the event of catastrophic network breakdown or in cases of force majeure. Member States shall ensure that providers of voice communications services take all necessary measures to ensure uninterrupted access to emergency services and uninterrupted transmission of public warnings. Article 109 Emergency communications and the single European emergency number 1. Member States shall ensure that all end-users of the services referred to in paragraph 2, including users of public pay telephones, are able to access the emergency services through emergency communications free of charge and without having to use any means of payment, by using the single European emergency number ‘112’ and any national emergency number specified by Member States. Member States shall promote the access to emergency services through the single European emergency number ‘112’ from electronic communications networks which are not publicly available but which enable calls to public networks, in particular when the undertaking responsible for that network does not provide an alternative and easy access to an emergency service. 2. Member States shall, after consulting national regulatory authorities and emergency services and providers of electronic communications services, ensure that providers of publicly available number-based interpersonal communications services, where those services allow end-users to originate calls to a number in a national or international numbering plan, provide access to emergency services through emergency communications to the most appropriate PSAP. 3. Member States shall ensure that all emergency communications to the single European emergency number ‘112’ are appropriately answered and handled in the manner best suited to the national organisation of emergency systems. Such emergency communications shall be answered and handled at least as expeditiously and effectively as emergency communications to the national emergency number or numbers, where those continue to be in use. 4. By 21 December 2020 and every two years thereafter, the Commission shall submit a report to the European Parliament and to the Council on the effectiveness of the implementation of the single European emergency number ‘112’. 5. Member States shall ensure that access for end-users with disabilities to emergency services is available through emergency communications and is equivalent to that enjoyed by other end-users, in accordance with Union law harmonising accessibility requirements for products and services. The Commission and the national regulatory or other competent authorities shall take appropriate measures to ensure that, whilst travelling in another Member State, end-users with disabilities can access emergency services on an equivalent basis with other end-users, where feasible without any pre-registration. Those measures shall seek to ensure interoperability across Member States and shall be based, to the greatest extent possible, on European standards or specifications laid down in accordance with Article 39. Such measures shall not prevent Member States from adopting additional requirements in order to pursue the objectives set out in this Article. 6. Member States shall ensure that caller location information is made available to the most appropriate PSAP without delay after the emergency communication is set up. This shall include network-based location information and, where available, handset-derived caller location information. Member States shall ensure that the establishment and the transmission of the caller location information are free of charge for the end-user and the PSAP with regard to all emergency communications to the single European emergency number ‘112’. Member States may extend that obligation to cover emergency communications to national emergency numbers. Competent regulatory authorities, if necessary after consulting BEREC, shall lay down criteria for the accuracy and reliability of the caller location information provided. 7. Member States shall ensure that end-users are adequately informed about the existence and the use of the single European emergency number ‘112’, as well as its accessibility features, including through initiatives specifically targeting persons travelling between Member States and end-users with disabilities. That information shall be provided in accessible formats, addressing different types of disabilities. The Commission shall support and complement Member States’ action. 8. In order to ensure effective access to emergency services through emergency communications to the single European emergency number ‘112’ in the Member States, the Commission shall, after consulting BEREC, adopt delegated acts in accordance with Article 117 supplementing paragraphs 2, 5 and 6 of this Article on the measures necessary to ensure the compatibility, interoperability, quality, reliability and continuity of emergency communications in the Union with regard to caller location information solutions, access for end-users with disabilities and routing to the most appropriate PSAP. The first such delegated act shall be adopted by 21 December 2022. Those delegated acts shall be adopted without prejudice to, and shall have no impact on, the organisation of emergency services, which remains in the exclusive competence of Member States. BEREC shall maintain a database of E.164 numbers of Member State emergency services to ensure that they are able to contact each other from one Member State to another, if such a database is not maintained by another organisation. Article 110 Public warning system 1. By 21 June 2022, Member States shall ensure that, when public warning systems regarding imminent or developing major emergencies and disasters are in place, public warnings are transmitted by providers of mobile number-based interpersonal communications services to the end-users concerned. 2. Notwithstanding paragraph 1, Member States may determine that public warnings be transmitted through publicly available electronic communications services other than those referred to in paragraph 1, and other than broadcasting services, or through a mobile application relying on an internet access service, provided that the effectiveness of the public warning system is equivalent in terms of coverage and capacity to reach end-users, including those only temporarily present in the area concerned, taking utmost account of BEREC guidelines. Public warnings shall be easy for end-users to receive. By 21 June 2020, and after consulting the authorities in charge of PSAPs, BEREC shall publish guidelines on how to assess whether the effectiveness of public warning systems under this paragraph is equivalent to the effectiveness of those under paragraph 1. Article 111 Equivalent access and choice for end-users with disabilities 1. Member States shall ensure that the competent authorities specify requirements to be met by providers of publicly available electronic communications services to ensure that end-users with disabilities: (a) have access to electronic communications services, including the related contractual information provided pursuant to Article 102, equivalent to that enjoyed by the majority of end-users; and (b) benefit from the choice of undertakings and services available to the majority of end-users. 2. In taking the measures referred to in paragraph 1 of this Article, Member States shall encourage compliance with the relevant standards or specifications laid down in accordance with Article 39. Article 112 Directory enquiry services 1. Member States shall ensure that all providers of number-based interpersonal communications services which attribute numbers from a numbering plan meet all reasonable requests to make available, for the purposes of the provision of publicly available directory enquiry services and directories, the relevant information in an agreed format, on terms which are fair, objective, cost oriented and non-discriminatory. 2. National regulatory authorities shall be empowered to impose obligations and conditions on undertakings that control access to end-users, for the provision of directory enquiry services, in accordance with Article 61. Such obligations and conditions shall be objective, equitable, non-discriminatory and transparent. 3. Member States shall not maintain any regulatory restrictions which prevent end-users in one Member State from accessing directly the directory enquiry service in another Member State by voice call or SMS, and shall take measures to ensure such access in accordance with Article 97. 4. This Article shall apply subject to the requirements of Union law on the protection of personal data and privacy and, in particular, Article 12 of Directive 2002/58/EC. Article 113 Interoperability of car radio and consumer radio receivers and consumer digital television equipment 1. Member States shall ensure the interoperability of car radio receivers and consumer digital television equipment in accordance with Annex XI. 2. Member States may adopt measures to ensure the interoperability of other consumer radio receivers, while limiting the impact on the market for low-value radio broadcast receivers and ensuring that such measures are not applied to products where a radio receiver is purely ancillary, such as smartphones, and to equipment used by radio amateurs. 3. Member States shall encourage providers of digital television services to ensure, where appropriate, that the digital television equipment that they provide to their end-users is interoperable so that, where technically feasible, the digital television equipment is reusable with other providers of digital television services. Without prejudice to Article 5(2) of Directive 2012/19/EU of the European Parliament and of the Council (47), Member States shall ensure that, upon termination of their contract, end-users have the possibility to return the digital television equipment through a free and easy process, unless the provider demonstrates that it is fully interoperable with the digital television services of other providers, including those to which the end-user has switched. Digital television equipment which complies with harmonised standards the references of which have been published in the Official Journal of the European Union, or with parts thereof, shall be considered to comply with the requirement of interoperability set out in the second subparagraph covered by those standards or parts thereof. Article 114 ‘Must carry’ obligations 1. Member States may impose reasonable ‘must carry’ obligations for the transmission of specified radio and television broadcast channels and related complementary services, in particular accessibility services to enable appropriate access for end-users with disabilities and data supporting connected television services and EPGs, on undertakings under their jurisdiction providing electronic communications networks and services used for the distribution of radio or television broadcast channels to the public, where a significant number of end-users of such networks and services use them as their principal means to receive radio and television broadcast channels. Such obligations shall be imposed only where they are necessary to meet general interest objectives as clearly defined by each Member State and shall be proportionate and transparent. 2. By 21 December 2019 and every five years thereafter, Member States shall review the obligations referred to in the paragraph 1, except where Member States have carried out such a review within the previous four years. 3. Neither paragraph 1 of this Article nor Article 59(2) shall prejudice the ability of Member States to determine appropriate remuneration, if any, in respect of measures taken in accordance with this Article while ensuring that, in similar circumstances, there is no discrimination in the treatment of providers of electronic communications networks and services. Where remuneration is provided for, Member States shall ensure that the obligation to remunerate is clearly set out in national law, including, where relevant, the criteria for calculating such remuneration. Member States shall also ensure that it is applied in a proportionate and transparent manner. Article 115 Provision of additional facilities 1. Without prejudice to Article 88(2), Member States shall ensure that competent authorities in coordination, where relevant, with national regulatory authorities are able to require all providers of internet access services or publicly available number-based interpersonal communications services to make available free of charge all or part of the additional facilities listed in Part B of Annex VI, subject to technical feasibility, as well as all or part of the additional facilities listed in Part A of Annex VI. 2. When applying paragraph 1, Member States may go beyond the list of additional facilities in Parts A and B of Annex VI in order to ensure a higher level of consumer protection. 3. A Member State may decide to waive the application of paragraph 1 in all or part of its territory if it considers, after taking into account the views of interested parties, that there is sufficient access to those facilities. Article 116 Adaptation of annexes The Commission is empowered to adopt delegated acts in accordance with Article 117 amending Annexes V, VI, IX, X, and XI in order to take account of technological and social developments or changes in market demand. PART IV FINAL PROVISIONS Article 117 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 75, 109 and 116 shall be conferred on the Commission for a period of five years from 20 December 2018. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 75, 109 and 116 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 75, 109 and 116 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 118 Committee 1. The Commission shall be assisted by a committee (‘the Communications Committee’). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. For the implementing acts referred to in the second subparagraph of Article 28(4), the Commission shall be assisted by the Radio Spectrum Committee established pursuant to Article 3(1) of Decision No 676/2002/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 3. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a committee member so requests. In such a case, the chair shall convene a committee meeting within a reasonable time. 4. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply, having regard to Article 8 thereof. Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a committee member so requests. In such a case, the chair shall convene a committee meeting within a reasonable time. Article 119 Exchange of information 1. The Commission shall provide all relevant information to the Communications Committee on the outcome of regular consultations with the representatives of network operators, service providers, users, consumers, manufacturers and trade unions, as well as third countries and international organisations. 2. The Communications Committee shall, taking account of the Union’s electronic communications policy, foster the exchange of information between the Member States and between the Member States and the Commission on the situation and the development of regulatory activities regarding electronic communications networks and services. Article 120 Publication of information 1. Member States shall ensure that up-to-date information regarding the implementation of this Directive is made publicly available in a manner that guarantees all interested parties easy access to that information. They shall publish a notice in their national official gazette describing how and where the information is published. The first such notice shall be published before 21 December 2020 and thereafter a notice shall be published where there is any change in the information contained therein. 2. Member States shall submit to the Commission a copy of all such notices at the time of publication. The Commission shall distribute the information to the Communications Committee as appropriate. 3. Member States shall ensure that all relevant information on rights, conditions, procedures, charges, fees and decisions concerning general authorisations, rights of use and rights to install facilities is published and kept up to date in an appropriate manner in order to provide easy access to that information for all interested parties. 4. Where information referred to in paragraph 3 is held at different levels of government, in particular information regarding procedures and conditions on rights to install facilities, the competent authority shall make all reasonable efforts, having regard to the costs involved, to create a user-friendly overview of all such information, including information on the relevant levels of government and the responsible authorities, in order to facilitate applications for rights to install facilities. 5. Member States shall ensure that the specific obligations imposed on undertakings under this Directive are published and that the specific product and service, and geographical markets are identified. Subject to the need to protect commercial confidentiality, they shall ensure that up-to-date information is made publicly available in a manner that guarantees all interested parties easy access to that information. 6. Member States shall provide the Commission with information that they make publicly available pursuant to paragraph 5. The Commission shall make that information available in a readily accessible form, and shall distribute the information to the Communications Committee as appropriate. Article 121 Notification and monitoring 1. National regulatory authorities shall notify to the Commission by 21 December 2020, and immediately following any change thereafter, the names of undertakings designated as having universal service obligations under Article 85(2), Article 86 or 87. 2. National regulatory authorities shall notify to the Commission the names of undertakings designated as having significant market power for the purposes of this Directive, and the obligations imposed upon them under this Directive. Any changes affecting the obligations imposed upon undertakings or of the undertakings affected under this Directive shall be notified to the Commission without delay. Article 122 Review procedures 1. By 21 December 2025 and every five years thereafter, the Commission shall review the functioning of this Directive and report to the European Parliament and to the Council. Those reviews shall evaluate in particular the market implications of Article 61(3) and Articles 76, 78 and 79 and whether the ex ante and other intervention powers pursuant to this Directive are sufficient to enable national regulatory authorities to address uncompetitive oligopolistic market structures, and to ensure that competition in electronic communications markets continues to thrive to the benefit of end-users. To that end, the Commission may request information from the Member States, which shall be supplied without undue delay. 2. By 21 December 2025, and every five years thereafter, the Commission shall review the scope of universal service, in particular with a view to proposing to the European Parliament and to the Council that the scope be changed or redefined. That review shall be undertaken in light of social, economic and technological developments, taking into account, inter alia, mobility and data rates in light of the prevailing technologies used by the majority of end-users. The Commission shall submit a report to the European Parliament and to the Council regarding the outcome of the review. 3. BEREC shall, by 21 December 2021 and every three years thereafter, publish an opinion on the national implementation and functioning of the general authorisation, and on their impact on the functioning of the internal market. The Commission may, taking utmost account of the BEREC opinion, publish a report on the application of Chapter II of Title II of Part I and of Annex I, and may submit a legislative proposal to amend those provisions where it considers this to be necessary for the purpose of addressing obstacles to the proper functioning of the internal market. Article 123 Specific review procedure on end-user rights 1. BEREC shall monitor the market and technological developments regarding the different types of electronic communications services and shall, by 21 December 2021 and every three years thereafter, or upon a reasoned request from at least two of its Member State members, publish an opinion on such developments and on their impact on the application of Title III of Part III. In that opinion, BEREC shall assess to what extent Title III of Part III meets the objectives set out in Article 3. The opinion shall in particular take into account the scope of Title III of Part III as regards the types of electronic communications services covered. As a basis for the opinion, BEREC shall in particular analyse: (a) to what extent end-users of all electronic communications services are able to make free and informed choices, including on the basis of complete contractual information, and are able to switch easily their provider of electronic communications services; (b) to what extent any lack of abilities referred to in point (a) has resulted in market distortions or end-user harm; (c) to what extent effective access to emergency services is appreciably threatened, in particular due to an increased use of number-independent interpersonal communications services, by a lack of interoperability or technological developments; (d) the likely cost of any potential readjustments of obligations in Title III of Part III or impact on innovation for providers of electronic communications services. 2. The Commission, taking utmost account of the BEREC opinion, shall publish a report on the application of Title III of Part III and shall submit a legislative proposal to amend that Title where it considers this to be necessary to ensure that the objectives set out in Article 3 continue to be met. Article 124 Transposition 1. Member States shall adopt and publish, by 21 December 2020, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately communicate the text of those measures to the Commission. Member States shall apply those measures from 21 December 2020. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directives repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated. 2. By way of derogation from paragraph 1 of this Article, Article 53(2), (3) and (4) of this Directive shall apply from 20 December 2018 where harmonised conditions have been set by technical implementing measures in accordance with Decision No 676/2002/EC in order to enable the radio spectrum use for wireless broadband networks and services. In relation to radio spectrum bands for which harmonised conditions have not been set by 20 December 2018, Article 53(2), (3) and (4) of this Directive shall apply from the date of the adoption of the technical implementing measures in accordance with Article 4 of Decision No 676/2002/EC. By way of derogation from paragraph 1 of this Article, Member States shall apply the measures necessary to comply with Article 54 from 31 December 2020. 3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article 125 Repeal Directives 2002/19/EC, 2002/20/EC, 2002/21/EC, 2002/22/EC, as listed in Annex XII, Part A, are repealed with effect from 21 December 2020, without prejudice to the obligations of the Member States relating to the time-limits for the transposition into national law and the dates of application of the Directives set out in Annex XII, Part B. Article 5 of Decision No 243/2012/EU is deleted with effect from 21 December 2020. References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex XIII. Article 126 Entry into force This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 127 Addressees This Directive is addressed to the Member States. Done at Strasbourg, 11 December 2018. For the European Parliament The President A. TAJANI For the Council The President J. BOGNER-STRAUSS (1) OJ C 125, 21.4.2017, p. 56. (2) OJ C 207, 30.6.2017, p. 87. (3) Position of the European Parliament of 14 November 2018 (not yet published in the Official Journal) and decision of the Council of 4 December 2018. (4) Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities (Access Directive) (OJ L 108, 24.4.2002, p. 7). (5) Directive 2002/20/EC of the European Parliament and of the Council of 7 March 2002 on the authorisation of electronic communications networks and services (Authorisation Directive) (OJ L 108, 24.4.2002, p. 21). (6) Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive) (OJ L 108, 24.4.2002, p. 33) (7) Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users’ rights relating to electronic communications networks and services (Universal Service Directive) (OJ L 108, 24.4.2002, p. 51). (8) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37). (9) Regulation (EC) No 1211/2009 of the European Parliament and of the Council of 25 November 2009 establishing the Body of European Regulators for Electronic Communications (BEREC) and the Office (OJ L 337, 18.12.2009, p. 1). (10) OJ C 77, 28.3.2002, p. 1. (11) Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 95, 15.4.2010, p. 1). (12) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). (13) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (14) Regulation (EU) 2015/2120 of the European Parliament and of the Council of 25 November 2015 laying down measures concerning open internet access and amending Directive 2002/22/EC on universal service and users’ rights relating to electronic communications networks and services and Regulation (EU) No 531/2012 on roaming on public mobile communications networks within the Union (OJ L 310, 26.11.2015, p. 1). (15) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (16) Judgment of the Court of Justice of 26 April 1988, Bond van Adverteerders and Others v The Netherlands State, C-352/85, ECLI: EU:C:1988:196. (17) Regulation (EU) 2015/758 of the European Parliament and of the Council of 29 April 2015 concerning type-approval requirements for the deployment of the eCall in-vehicle system based on the 112 service and amending Directive 2007/46/EC (OJ L 123, 19.5.2015, p 77). (18) Commission Regulation (EU) No 305/2013 of 26 November 2012 supplementing Directive 2010/40/EU of the European Parliament and of the Council with regard to the harmonised provision for an interoperable EU-wide eCall (OJ L 91, 3.4.2013, p. 1). (19) Decision No 243/2012/EU of the European Parliament and of the Council of 14 March 2012 establishing a multiannual radio spectrum policy programme (OJ L 81, 21.3.2012, p. 7). (20) Regulation (EU) No 531/2012 of the European Parliament and of the Council of 13 June 2012 on roaming on public mobile communications networks within the Union (OJ L 172, 30.6.2012, p. 10). (21) in particular the judgment of the Court of Justice of 16 October 2012, European Commission v Republic of Austria, Case C-614/10, ECLI:EU:C:2012:631. (22) Directive 2014/61/EU of the European Parliament and of the Council of 15 May 2014 on measures to reduce the cost of deploying high-speed electronic communications networks (OJ L 155, 23.5.2014, p. 1). (23) Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) (OJ L 177, 4.7.2008, p. 6). (24) Decision No 676/2002/EC of the European Parliament and of the Council of 7 March 2002 on a regulatory framework for radio spectrum policy in the European Community (Radio Spectrum Decision) (OJ L 108, 24.4.2002, p. 1). (25) Directive 2003/98/EC of the European Parliament and of the Council of 17 November 2003 on the re-use of public sector information (OJ L 345, 31.12.2003, p. 90). (26) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (27) Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Directive on consumer ADR) (OJ L 165, 18.6.2013, p. 63). (28) Commission Decision 2002/622/EC of 26 July 2002 establishing a Radio Spectrum Policy Group (OJ L 198, 27.7.2002, p. 49). (29) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79). (30) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357). (31) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1). (32) Council Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz) (OJ L 199, 30.7.1999, p. 59). (33) Decision (EU) 2017/899 of the European Parliament and of the Council of 17 May 2017 on the use of the 470-790 MHz frequency band in the Union (OJ L 138, 25.5.2017, p. 131). (34) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1). (35) Commission Recommendation 2005/698/EC of 19 September 2005 on accounting separation and cost accounting systems under the regulatory framework for electronic communications (OJ L 266, 11.10.2005, p. 64). (36) Commission Recommendation 2013/466/EU of 11 September 2013 on consistent non-discrimination obligations and costing methodologies to promote competition and enhance the broadband investment environment (OJ L 251, 21.9.2013, p. 13). (37) Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29). (38) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). (39) Commission Directive 2002/77/EC of 16 September 2002 on competition in the markets for electronic communications networks and services (OJ L 249, 17.9.2002, p. 21). (40) OJ L 123, 12.5.2016, p. 1. (41) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (42) OJ C 369, 17.12.2011, p. 14. (43) Commission Directive 2008/63/EC of 20 June 2008 on competition in the markets in telecommunications terminal equipment (OJ L 162, 21.6.2008, p. 20). (44) Regulation (EU) 2018/1971 of the European Parliament and of the Council of 11 December 2018 establishing the Body of European Regulators for Electronic Communications (BEREC) and the Agency for Support for BEREC (BEREC Office), amending Regulation (EU) 2015/2120 and repealing Regulation (EC) No 1211/2009 (see page 1 of this Official Journal). (45) Regulation (EU) No 526/2013 of the European Parliament and of the Council of 21 May 2013 concerning the European Union Agency for Network and Information Security (ENISA) and repealing Regulation (EC) No 460/2004 (OJ L 165, 18.6.2013, p. 41). (46) Regulation (EU) No 1315/2013 of the European Parliament and of the Council of 11 December 2013 on Union guidelines for the development of the trans-European transport network and repealing Decision No 661/2010/EU (OJ L 348 20.12.2013, p. 1). (47) Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38). ANNEX I LIST OF CONDITIONS WHICH MAY BE ATTACHED TO GENERAL AUTHORISATIONS, RIGHTS OF USE FOR RADIO SPECTRUM AND RIGHTS OF USE FOR NUMBERING RESOURCES This Annex provides for the maximum list of conditions which may be attached to general authorisations for electronic communications networks and services, except number-independent interpersonal communications services (Part A), electronic communications networks (Part B), electronic communications services, except number-independent interpersonal communications services (Part C), rights of use for radio spectrum (Part D), and rights of use for numbering resources (Part E) A. General conditions which may be attached to a general authorisation 1. Administrative charges in accordance with Article 16. 2. Personal data and privacy protection specific to the electronic communications sector in accordance with Directive 2002/58/EC 3. Information to be provided under a notification procedure in accordance with Article 12 and for other purposes as included in Article 21. 4. Enabling of legal interception by competent national authorities in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC. 5. Terms of use for communications from public authorities to the general public for warning the public of imminent threats and for mitigating the consequences of major catastrophes. 6. Terms of use during major disasters or national emergencies to ensure communications between emergency services and authorities. 7. Access obligations other than those provided for in Article 13 applying to undertakings providing electronic communications networks or services. 8. Measures designed to ensure compliance with the standards or specifications referred to in Article 39. 9. Transparency obligations on providers of public electronic communications network providing publicly available electronic communications services to ensure end-to-end connectivity, in accordance with the objectives and principles set out in Article 3 and, where necessary and proportionate, access by competent authorities to such information needed to verify the accuracy of such disclosure. B. Specific conditions which may be attached to a general authorisation for the provision of electronic communications networks 1. Interconnection of networks in accordance with this Directive. 2. ‘Must carry’ obligations in accordance with this Directive. 3. Measures for the protection of public health against electromagnetic fields caused by electronic communications networks in accordance with Union law, taking utmost account of Recommendation 1999/519/EC. 4. Maintenance of the integrity of public electronic communications networks in accordance with this Directive including by conditions to prevent electromagnetic interference between electronic communications networks or services in accordance with Directive 2014/30/EU. 5. Security of public networks against unauthorised access in accordance with Directive 2002/58/EC. 6. Conditions for the use of radio spectrum, in accordance with Article 7(2) of Directive 2014/53/EU, where such use is not made subject to the granting of individual rights of use in accordance with Article 46(1) and Article 48 of this Directive. C. Specific conditions which may be attached to a general authorisation for the provision of electronic communications services, except number-independent interpersonal communications services 1. Interoperability of services in accordance with this Directive. 2. Accessibility by end-users of numbers from the national numbering plan, numbers from the UIFN and, where technically and economically feasible, from numbering plans of other Member States, and conditions in accordance with this Directive. 3. Consumer protection rules specific to the electronic communications sector. 4. Restrictions in relation to the transmission of illegal content in accordance with Directive 2000/31/EC and restrictions in relation to the transmission of harmful content in accordance with Directive 2010/13/EU. D. Conditions which may be attached to rights of use for radio spectrum 1. Obligation to provide a service or to use a type of technology within the limits of Article 45 including, where appropriate, coverage and quality of service requirements. 2. Effective and efficient use of radio spectrum in accordance with this Directive. 3. Technical and operational conditions necessary for the avoidance of harmful interference and for the protection of public health against electromagnetic fields, taking utmost account of Recommendation 1999/519/EC where such conditions are different from those included in the general authorisation. 4. Maximum duration in accordance with Article 49, subject to any changes in the National Frequency Allocation Plan. 5. Transfer or leasing of rights at the initiative of the holder of the rights and conditions for such transfer in accordance with this Directive. 6. Fees for rights of use in accordance with Article 42. 7. Any commitments which the undertaking obtaining the rights of use has made in the framework of an authorisation or authorisation renewal process prior to the authorisation being granted or, where applicable, to the invitation for application for rights of use. 8. Obligations to pool or share radio spectrum or allow access to radio spectrum for other users in specific regions or at national level. 9. Obligations under relevant international agreements relating to the use of radio spectrum bands. 10. Obligations specific to an experimental use of radio spectrum bands. E. Conditions which may be attached to rights of use for numbering resources 1. Designation of service for which the number shall be used, including any requirements linked to the provision of that service and, for the avoidance of doubt, tariff principles and maximum prices that can apply in the specific number range for the purposes of ensuring consumer protection in accordance with point (d) of Article 3(2). 2. Effective and efficient use of numbering resources in accordance with this Directive. 3. Number portability requirements in accordance with this Directive. 4. Obligation to provide public directory end-user information for the purposes of Article 112. 5. Maximum duration in accordance with Article 94, subject to any changes in the national numbering plan. 6. Transfer of rights at the initiative of the holder of the rights and conditions for such transfer in accordance with this Directive, including any condition that the right of use for a number be binding on all the undertakings to which the rights are transferred. 7. Fees for rights of use in accordance with Article 95. 8. Any commitments which the undertaking obtaining the rights of use has made in the course of a competitive or comparative selection procedure. 9. Obligations under relevant international agreements relating to the use of numbers. 10. Obligations concerning the extraterritorial use of numbers within the Union to ensure compliance with consumer protection and other number-related rules in Member States other than that of the country code. ANNEX II CONDITIONS FOR ACCESS TO DIGITAL TELEVISION AND RADIO SERVICES BROADCAST TO VIEWERS AND LISTENERS IN THE UNION Part I Conditions for conditional access systems to be applied in accordance with Article 62(1) In relation to conditional access to digital television and radio services broadcast to viewers and listeners in the Union, irrespective of the means of transmission, Member States shall ensure in accordance with Article 62 that the following conditions apply: (a) all undertakings providing conditional access services, irrespective of the means of transmission, which provide access services to digital television and radio services and the access services of which broadcasters depend on to reach any group of potential viewers or listeners are to: — offer to all broadcasters, on a fair, reasonable and non-discriminatory basis compatible with Union competition law, technical services enabling the broadcasters’ digitally-transmitted services to be received by viewers or listeners authorised by means of decoders administered by the service operators, and comply with Union competition law, — keep separate financial accounts regarding their activity as conditional access providers. (b) when granting licences to manufacturers of consumer equipment, holders of industrial property rights to conditional access products and systems are to ensure that this is done on fair, reasonable and non-discriminatory terms. Taking into account technical and commercial factors, holders of rights are not to subject the granting of licences to conditions prohibiting, deterring or discouraging the inclusion in the same product of: — a common interface allowing connection with several other access systems, or — means specific to another access system, provided that the licensee complies with the relevant and reasonable conditions ensuring, as far as he is concerned, the security of transactions of conditional access system operators. Part II Other facilities to which conditions may be applied under point (D) of Article 61(2) (a) Access to APIs; (b) Access to EPGs. ANNEX III CRITERIA FOR THE DETERMINATION OF WHOLESALE VOICE TERMINATION RATES Principles, criteria and parameters for the determination of rates for wholesale voice termination on fixed and mobile markets referred to in Article 75(1): (a) rates shall be based on the recovery of costs incurred by an efficient operator; the evaluation of efficient costs shall be based on current cost values; the cost methodology to calculate efficient costs shall be based on a bottom-up modelling approach using long-run incremental traffic-related costs of providing the wholesale voice termination service to third parties; (b) the relevant incremental costs of the wholesale voice termination service shall be determined by the difference between the total long-run costs of an operator providing its full range of services and the total long-run costs of that operator not providing a wholesale voice termination service to third parties; (c) only those traffic-related costs which would be avoided in the absence of a wholesale voice termination service being provided shall be allocated to the relevant termination increment; (d) costs related to additional network capacity shall be included only to the extent that they are driven by the need to increase capacity for the purpose of carrying additional wholesale voice termination traffic; (e) radio spectrum fees shall be excluded from the mobile voice termination increment; (f) only those wholesale commercial costs shall be included which are directly related to the provision of the wholesale voice termination service to third parties; (g) all fixed network operators shall be considered to provide voice termination services at the same unit costs as the efficient operator, regardless of their size; (h) for mobile network operators, the minimum efficient scale shall be set at a market share not below 20 %; (i) the relevant approach for asset depreciation shall be economic depreciation; and (j) the technology choice of the modelled networks shall be forward looking, based on an IP core network, taking into account the various technologies likely to be used over the period of validity of the maximum rate; in the case of fixed networks, calls shall be considered to be exclusively packet switched. ANNEX IV CRITERIA FOR ASSESSING CO-INVESTMENT OFFERS When assessing a co-investment offer pursuant to Article 76(1), the national regulatory authority shall verify whether the following criteria have at a minimum been met. National regulatory authorities may consider additional criteria to the extent they are necessary to ensure accessibility of potential investors to the co-investment, in light of specific local conditions and market structure: (a) The co-investment offer shall be open to any undertaking over the lifetime of the network built under a co-investment offer on a non-discriminatory basis. The undertaking designated as having significant market power may include in the offer reasonable conditions regarding the financial capacity of any undertaking, so that for instance potential co-investors need to demonstrate their ability to deliver phased payments on the basis of which the deployment is planned, the acceptance of a strategic plan on the basis of which medium-term deployment plans are prepared, and so on. (b) The co-investment offer shall be transparent: — the offer shall be available and easily identified on the website of the undertaking designated as having significant market power; — full detailed terms shall be made available without undue delay to any potential bidder that has expressed an interest, including the legal form of the co-investment agreement and, when relevant, the heads of term of the governance rules of the co-investment vehicle; and — the process, like the road map for the establishment and development of the co-investment project shall be set in advance, shall be clearly explained in writing to any potential co-investor, and all significant milestones shall be clearly communicated to all undertakings without any discrimination. (c) The co-investment offer shall include terms to potential co-investors which favour sustainable competition in the long term, in particular: — All undertakings shall be offered fair, reasonable and non-discriminatory terms and conditions for participation in the co-investment agreement relative to the time they join, including in terms of financial consideration required for the acquisition of specific rights, in terms of the protection awarded to the co-investors by those rights both during the building phase and during the exploitation phase, for example by granting indefeasible rights of use (IRUs) for the expected lifetime of the co-invested network and in terms of the conditions for joining and potentially terminating the co-investment agreement. Non-discriminatory terms in this context do not entail that all potential co-investors shall be offered exactly the same terms, including financial terms, but that all variations of the terms offered shall be justified on the basis of the same objective, transparent, non-discriminatory and predictable criteria such as the number of end-user lines committed for. — The offer shall allow flexibility in terms of the value and timing of the commitment provided by each co-investor, for example by means of an agreed and potentially increasing percentage of the total end-user lines in a given area, to which co-investors have the possibility to commit gradually and which is set at a unit level enabling smaller co-investors with limited resources to enter the co-investment at a reasonably minimum scale and to gradually increase their participation while ensuring adequate levels of initial commitment. The determination of the financial consideration to be provided by each co-investor needs to reflect the fact that early investors accept greater risks and engage capital sooner. — A premium increasing over time shall be considered to be justified for commitments made at later stages and for new co-investors entering the co-investment after the commencement of the project, to reflect diminishing risks and to counteract any incentive to withhold capital in the earlier stages. — The co-investment agreement shall allow the assignment of acquired rights by co-investors to other co-investors, or to third parties willing to enter into the co-investment agreement subject to the transferee undertaking being obliged to fulfil all original obligations of the transferor under the co-investment agreement. — Co-investors shall grant each other reciprocal rights on fair and reasonable terms and conditions to access the co-invested infrastructure for the purposes of providing services downstream, including to end-users, in accordance with transparent conditions which are to be made transparent in the co-investment offer and subsequent agreement, in particular where co-investors are individually and separately responsible for the deployment of specific parts of the network. If a co-investment vehicle is created, it shall provide access to the network to all co-investors, whether directly or indirectly, on an equivalence of inputs basis and in accordance with fair and reasonable terms and conditions, including financial conditions that reflect the different levels of risk accepted by the individual co-investors. (d) The co-investment offer shall ensure a sustainable investment likely to meet future needs, by deploying new network elements that contribute significantly to the deployment of very high capacity networks. ANNEX V MINIMUM SET OF SERVICES WHICH THE ADEQUATE BROADBAND INTERNET ACCESS SERVICE IN ACCORDANCE WITH ARTICLE 84(3) SHALL BE CAPABLE OF SUPPORTING (1) E-mail (2) search engines enabling search and finding of all type of information (3) basic training and education online tools (4) online newspapers or news (5) buying or ordering goods or services online (6) job searching and job searching tools (7) professional networking (8) internet banking (9) eGovernment service use (10) social media and instant messaging (11) calls and video calls (standard quality) ANNEX VI DESCRIPTION OF FACILITIES AND SERVICES REFERRED TO IN ARTICLE 88 (CONTROL OF EXPENDITURE), ARTICLE 115 (ADDITIONAL FACILITIES) AND ARTICLE 106 (PROVIDER SWITCHING AND NUMBER PORTABILITY) Part A Facilities and services referred to in Articles 88 and 115 When applied on the basis of Article 88, Part A is applicable to consumers and other categories of end-users where Member States have extended the beneficiaries of Article 88(2). When applied on the basis of Article 115, Part A is applicable to the categories of end-users determined by Member States, except for points (c), (d) and (g) of this Part which are applicable only to consumers. (a) Itemised billing Member States shall ensure that competent authorities in coordination, where relevant, with national regulatory authorities, subject to the requirements of relevant law on the protection of personal data and privacy, may lay down the basic level of itemised bills which are to be offered by providers to end-users free of charge in order that they can: (i) allow verification and control of the charges incurred in using internet access services or voice communications services, or number-based interpersonal communications services in the case of Article 115; and (ii) adequately monitor their usage and expenditure and thereby exercise a reasonable degree of control over their bills. Where appropriate, additional levels of detail may be offered to end-users at reasonable tariffs or at no charge. Such itemised bills shall include an explicit mention of the identity of the supplier and of the duration of the services charged by any premium numbers unless the end-user has requested that information not to be mentioned. Calls which are free of charge to the calling end-users, including calls to helplines, shall not be required to be identified in the calling end-user’s itemised bill. National regulatory authorities may require operators to provide calling-line identification free of charge. (b) Selective barring for outgoing calls or premium SMS or MMS, or, where technically feasible, other kinds of similar applications, free of charge namely, the facility whereby the end-users can, on request to the providers of voice communications services, or number-based interpersonal communications services in the case of Article 115, bar outgoing calls or premium SMS or MMS or other kinds of similar applications of defined types or to defined types of numbers free of charge. (c) Pre-payment systems Member States shall ensure that competent authorities in coordination, where relevant, with national regulatory authorities may require providers to offer means for consumers to pay for access to the public electronic communications network and use of voice communications services, or internet access services, or number-based interpersonal communications services in the case of Article 115, on pre-paid terms. (d) Phased payment of connection fees Member States shall ensure that competent authorities in coordination, where relevant, with national regulatory authorities may require providers to allow consumers to pay for connection to the public electronic communications network on the basis of payments phased over time. (e) Non-payment of bills Member States shall authorise specified measures, which are to be proportionate, non-discriminatory and published, to cover non-payment of bills issued by providers. Those measures are to ensure that due warning of any consequent service interruption or disconnection is given to the end-users beforehand. Except in cases of fraud, persistent late payment or non-payment, those measures shall ensure, as far as is technically feasible, that any service interruption is confined to the service concerned. Disconnection for non-payment of bills shall take place only after due warning is given to the end-users. Member States may allow a period of limited service prior to complete disconnection, during which only calls that do not incur a charge to the end-users (for example, calls to the ‘112’ number) and minimum service level of internet access services, defined by Member States in light of national conditions, are permitted. (f) Tariff advice namely, the facility whereby end-users may request the provider to offer information regarding alternative lower-cost tariffs, if available. (g) Cost control namely, the facility whereby providers offer other means, if determined to be appropriate by competent authorities in coordination, where relevant, with national regulatory authorities, to control the costs of voice communications services or internet access services, or number-based interpersonal communications services in the case of Article 115, including free-of-charge alerts to consumers in the case of abnormal or excessive consumption patterns. (h) facility to deactivate third party billing namely, the facility for end-users to deactivate the ability for third party service providers to use the bill of a provider of an internet access service or a provider of a publicly available interpersonal communications service to charge for their products or services. Part B Facilities referred to in Article 115 (a) Calling-line identification namely, the calling party’s number is presented to the called party prior to the call being established. This facility shall be provided in accordance with relevant law on protection of personal data and privacy, in particular Directive 2002/58/EC. To the extent technically feasible, operators shall provide data and signals to facilitate the offering of calling-line identity and tone dialling across Member State boundaries. (b) E-mail forwarding or access to e-mails after termination of the contract with a provider of an internet access service. This facility shall, on request and free-of-charge, enable end-users who terminate their contract with a provider of an internet access service to either access their e-mails received on the e-mail address(es) based on the commercial name or trade mark of the former provider, during a period that the national regulatory authority considers necessary and proportionate, or to transfer e-mails sent to that (or those) address(es) during that period to a new email address specified by the end-user. Part C Implementation of the number portability provisions referred to in Article 106 The requirement that all end-users with numbers from the national numbering plan, who so request can retain their numbers independently of the undertaking providing the service shall apply: (a) in the case of geographic numbers, at a specific location; and (b) in the case of non-geographic numbers, at any location. This Part does not apply to the porting of numbers between networks providing services at a fixed location and mobile networks. ANNEX VII CALCULATING THE NET COST, IF ANY, OF UNIVERSAL SERVICE OBLIGATIONS AND ESTABLISHING ANY COMPENSATION OR SHARING MECHANISM IN ACCORDANCE WITH ARTICLES 89 AND 90 Part A Calculation of net cost Universal service obligations refer to those obligations placed upon an undertaking by a Member State which concern the provision of universal service as set out in Articles 84 to 87. National regulatory authorities are to consider all means to ensure appropriate incentives for undertakings (designated or not) to provide universal service obligations cost efficiently. In undertaking a calculation exercise, the net cost of universal service obligations is to be calculated as the difference between the net cost for any undertaking operating with the universal service obligations and operating without the universal service obligations. Due attention is to be given to correctly assessing the costs that any undertaking would have chosen to avoid had there been no universal service obligations. The net cost calculation shall assess the benefits, including intangible benefits, to the universal service provider. The calculation is to be based upon the costs attributable to: (i) elements of the identified services which can only be provided at a loss or provided under cost conditions falling outside normal commercial standards. This category may include service elements such as access to emergency telephone services, provision of certain public pay telephones, provision of certain services or equipment for end-users with disabilities, and so on; (ii) specific end-users or groups of end-users who, taking into account the cost of providing the specified network and service, the revenue generated and any geographical averaging of prices imposed by the Member State, can only be served at a loss or under cost conditions falling outside normal commercial standards. This category includes those end-users or groups of end-users which would not be served by a commercial provider which did not have an obligation to provide universal service. The calculation of the net cost of specific aspects of universal service obligations is to be made separately and in order to avoid the double counting of any direct or indirect benefits and costs. The overall net cost of universal service obligations to any undertaking is to be calculated as the sum of the net costs arising from the specific components of universal service obligations, taking account of any intangible benefits. The responsibility for verifying the net cost lies with the national regulatory authority. Part B Compensation of net costs of universal service obligations The recovery or financing of any net costs of universal service obligations may require undertakings with universal service obligations to be compensated for the services they provide under non-commercial conditions. Because such a compensation involves financial transfers, Member States are to ensure that those are undertaken in an objective, transparent, non-discriminatory and proportionate manner. This means that the transfers result in the least distortion to competition and to user demand. In accordance with Article 90(3), a sharing mechanism based on a fund shall use a transparent and neutral means for collecting contributions that avoids the danger of a double imposition of contributions falling on both outputs and inputs of undertakings. The independent body administering the fund is to be responsible for collecting contributions from undertakings which are assessed as liable to contribute to the net cost of universal service obligations in the Member State and is to oversee the transfer of sums due or administrative payments to the undertakings entitled to receive payments from the fund. ANNEX VIII INFORMATION REQUIREMENTS TO BE PROVIDED IN ACCORDANCE WITH ARTICLE 102 (INFORMATION REQUIREMENTS FOR CONTRACTS) A. Information requirements for providers of publicly available electronic communications services other than transmission services used for the provision of machine-to-machine services Providers of publicly available electronic communications services other than transmission services used for the provision of machine-to-machine services shall provide the following information: (1) as part of the main characteristics of each service provided, any minimum levels of quality of service to the extent that those are offered and, for services other than internet access services, the specific quality parameters assured. Where no minimum levels of quality of service are offered, a statement to this effect shall be made; (2) as part of the information on price, where and to the extent applicable, the respective prices for activating the electronic communications service and for any recurring or consumption-related charges; (3) as part of the information on the duration of the contract and the conditions for renewal and termination of the contract, including possible termination fees, to the extent that such conditions apply: (i) any minimum use or duration required to benefit from promotional terms; (ii) any charges related to switching and compensation and refund arrangements for delay or abuse of switching, as well as information about the respective procedures; (iii) information on the right of consumers using pre-paid services to a refund, upon request, of any remaining credit in the event of switching, as set out in Article 106(6); (iv) any fees due on early termination of the contract, including information on unlocking the terminal equipment and any cost recovery with respect to terminal equipment; (4) any compensation and refund arrangements, including, where applicable, explicit reference to rights of consumers, which apply if contracted levels of quality of service are not met or if the provider responds inadequately to a security incident, threat or vulnerability; (5) the type of action that might be taken by the provider in reaction to security incidents or threats or vulnerabilities. B. Information requirements for providers of internet access services and publicly available interpersonal communications services I. In addition to the requirements set out in Part A, providers of internet access services and publicly available interpersonal communications services shall provide the following information: (1) as part of the main characteristics of each service provided: (i) any minimum levels of quality of service to the extent that these are offered, and taking utmost account of the BEREC guidelines adopted in accordance with Article 104(2) regarding: — for internet access services: at least latency, jitter, packet loss, — for publicly available interpersonal communications services, where they exert control over at least some elements of the network or have a service level agreement to that effect with undertakings providing access to the network: at least the time for the initial connection, failure probability, call signalling delays in accordance with Annex X; and (ii) without prejudice to the right of end-users to use terminal equipment of their choice in accordance with Article 3(1) of Regulation (EU) 2015/2120, any conditions, including fees, imposed by the provider on the use of terminal equipment supplied; (2) as part of the information on price, where and to the extent applicable, the respective prices for activating the electronic communications service and for any recurring or consumption-related charges: (i) details of specific tariff plan or plans under the contract and, for each such tariff plan the types of services offered, including where applicable, the volumes of communications (such as MB, minutes, messages) included per billing period, and the price for additional communication units; (ii) in the case of tariff plan or plans with a pre-set volume of communications, the possibility for consumers to defer any unused volume from the preceding billing period to the following billing period, where this option is included in the contract; (iii) facilities to safeguard bill transparency and monitor the level of consumption; (iv) tariff information regarding any numbers or services subject to particular pricing conditions; with respect to individual categories of services, competent authorities in coordination, where relevant, with national regulatory authorities may require in addition such information to be provided immediately prior to connecting the call or to connecting to the provider of the service; (v) for bundled services and bundles including both services and terminal equipment the price of the individual elements of the bundle to the extent they are also marketed separately; (vi) details and conditions, including fees, of any after-sales service, maintenance, and customer assistance; and (vii) the means by which up-to-date information on all applicable tariffs and maintenance charges may be obtained; (3) as part of the information on the duration of the contract for bundled services and the conditions for renewal and termination of the contract, where applicable, the conditions of termination of the bundle or of elements thereof; (4) without prejudice to Article 13 of the Regulation (EU) 2016/679, information on what personal data shall be provided before the performance of the service or collected in the context of the provision of the service; (5) details on products and services designed for end-users with disabilities and how updates on this information can be obtained; (6) the means of initiating procedures for the resolution of disputes including national and cross-border disputes in accordance with Article 25. II. In addition to the requirements set out in Part A and under Point I, providers of publicly available number-based interpersonal communications services shall also provide the following information: (1) any constraints on access to emergency services or caller location information due to a lack of technical feasibility insofar as the service allows end-users to originate calls to a number in a national or international numbering plan; (2) the end-user’s right to determine whether to include his or her personal data in a directory, and the types of data concerned, in accordance with Article 12 of Directive 2002/58/EC; III. In addition to the requirements set out in Part A and under Point I, providers of internet access services shall also provide the information required pursuant to Article 4(1) of Regulation (EU) 2015/2120. ANNEX IX INFORMATION TO BE PUBLISHED IN ACCORDANCE WITH ARTICLE 103 (TRANSPARENCY AND PUBLICATION OF INFORMATION) The competent authority in coordination, where relevant, with the national regulatory authority is responsible for ensuring that the information in this Annex is published, in accordance with Article 103. The competent authority in coordination, where relevant, with the national regulatory authority shall decide which information is relevant to be published by the providers of internet access services or publicly available interpersonal communications services, and which information is to be published by the competent authority itself in coordination, where relevant, with the national regulatory authority, in order to ensure that all end-users are able to make informed choices. If considered to be appropriate, competent authorities in coordination, where relevant, with national regulatory authorities may promote self- or co-regulatory measures prior to imposing any obligation. 1. Contact details of the undertaking 2. Description of the services offered 2.1. Scope of the services offered and the main characteristics of each service provided, including any minimum levels of quality of service where offered and any restrictions imposed by the provider on the use of terminal equipment supplied. 2.2. Tariffs of the services offered, including information on communications volumes (such as restrictions of data usage, numbers of voice minutes, numbers of messages) of specific tariff plans and the applicable tariffs for additional communication units, numbers or services subject to particular pricing conditions, charges for access and maintenance, all types of usage charges, special and targeted tariff schemes and any additional charges, as well as costs with respect to terminal equipment. 2.3. After-sales, maintenance and customer assistance services offered and their contact details. 2.4. Standard contract conditions, including contract duration, charges due on early termination of the contract, rights related to the termination of bundled offers or of elements thereof, and procedures and direct charges related to the portability of numbers and other identifiers, if relevant. 2.5. If the undertaking is a provider of number-based interpersonal communications services, information on access to emergency services and caller location, or any limitation on the latter. If the undertaking is a provider of number-independent interpersonal communications services, information on the degree to which access to emergency services may be supported or not. 2.6. Details of products and services, including any functions, practices, policies and procedures and alterations in the operation of the service, specifically designed for end-users with disabilities, in accordance with Union law harmonising accessibility requirements for products and services. 3. Dispute resolution mechanisms, including those developed by the undertaking. ANNEX X QUALITY OF SERVICE PARAMETERS Quality-of-Service Parameters, Definitions and Measurement Methods referred to in Article 104 For providers of access to a public electronic communications network PARAMETER (Note 1) DEFINITION MEASUREMENT METHOD Supply time for initial connection ETSI EG 202 057 ETSI EG 202 057 Fault rate per access line ETSI EG 202 057 ETSI EG 202 057 Fault repair time ETSI EG 202 057 ETSI EG 202 057 For providers of interpersonal communications services who exert control over at least some elements of the network or have a service level agreement to that effect with undertakings providing access to the network PARAMETER (Note 2) DEFINITION MEASUREMENT METHOD Call set up time ETSI EG 202 057 ETSI EG 202 057 Bill correctness complaints ETSI EG 202 057 ETSI EG 202 057 Voice connection quality ETSI EG 202 057 ETSI EG 202 057 Dropped call ratio ETSI EG 202 057 ETSI EG 202 057 Unsuccessful call ratio (Note 2) ETSI EG 202 057 ETSI EG 202 057 Failure probability Call signalling delays Version number of ETSI EG 202 057-1 is 1.3.1 (July 2008) For providers of internet access services PARAMETER DEFINITION MEASUREMENT METHOD Latency (delay) ITU-T Y.2617 ITU-T Y.2617 Jitter ITU-T Y.2617 ITU-T Y.2617 Packet loss ITU-T Y.2617 ITU-T Y.2617 Note 1 Parameters shall allow for performance to be analysed at a regional level (namely, no less than level 2 in the Nomenclature of Territorial Units for Statistics (NUTS) established by Eurostat). Note 2 Member States may decide not to require up-to-date information concerning the performance for those two parameters to be kept if evidence is available to show that performance in those two areas is satisfactory. ANNEX XI INTEROPERABILITY OF CAR RADIO RECEIVERS AND CONSUMER DIGITAL TELEVISION EQUIPMENT REFERRED TO IN ARTICLE 113 1. Common scrambling algorithm and free-to-air reception All consumer equipment intended for the reception of digital television signals (namely, broadcasting via terrestrial, cable or satellite transmission), for sale or rent or otherwise made available in the Union, capable of descrambling digital television signals, is to possess the capability to: (a) allow the descrambling of such signals in accordance with a common European scrambling algorithm as administered by a recognised European standardisation organisation (currently ETSI); (b) display signals that have been transmitted in the clear, provided that, in the event that such equipment is rented, the renter complies with the relevant rental agreement. 2. Interoperability for digital television sets Any digital television set with an integral screen of visible diagonal larger than 30 cm which is put on the market for sale or rent in the Union is to be fitted with at least one open interface socket (either standardised by, or conforming to a standard adopted by, a recognised European standardisation organisation, or conforming to an industry-wide specification) permitting simple connection of peripherals, and able to pass all relevant elements of a digital television signal, including information relating to interactive and conditionally accessed services. 3. Interoperability for car radio receivers Any car radio receiver integrated in a new vehicle of category M which is made available on the market for sale or rent in the Union from 21 December 2020 shall comprise a receiver capable of receiving and reproducing at least radio services provided via digital terrestrial radio broadcasting. Receivers which are in accordance with harmonised standards the references of which have been published in the Official Journal of the European Union or with parts thereof shall be considered to comply with that requirement covered by those standards or parts thereof. ANNEX XII Part A Repealed Directives with list of the successive amendments thereto (referred to in Article 125) Directive 2002/21/EC of the European Parliament and of the Council (OJ L 108, 24.4.2002, p. 33) Directive 2009/140/EC of the European Parliament and of the Council (OJ L 337, 18.12.2009, p. 37) Article 1 Regulation (EC) No 544/2009 of the European Parliament and of the Council (OJ L 167, 29.6.2009, p. 12) Article 2 Regulation (EC) No 717/2007 of the European Parliament and of the Council (OJ L 171, 29.6.2007, p. 32) Article 10 Directive 2002/20/EC of the European Parliament and of the Council (OJ L 108, 24.4.2002, p. 21) Directive 2009/140/EC of the European Parliament and of the Council (OJ L 337, 18.12.2009, p. 37) Article 3 and Annex Directive 2002/19/EC of the European Parliament and of the Council (OJ L 108, 24.4.2002, p. 7) Directive 2009/140/EC of the European Parliament and of the Council (OJ L 337, 18.12.2009, p. 37) Article 2 Directive 2002/22/EC of the European Parliament and of the Council (OJ L 108, 24.4.2002, p. 51) Directive 2009/136/EC of the European Parliament and of the Council (OJ L 337, 18.12.2009, p. 11) Article 1 and Annex I Regulation (EU) 2015/2120 of the European Parliament and of the Council (OJ L 310, 26.11.2015, p. 1) Article 8 Part B Time-limits for transposition into national law and dates of application (referred to in Article 125) Directive Time-limit for transposition Date of application 2002/19/EC 24 July 2003 25 July 2003 2002/20/EC 24 July 2003 25 July 2003 2002/21/EC 24 July 2003 25 July 2003 2002/22/EC 24 July 2003 25 July 2003 ANNEX XIII CORRELATION TABLE Directive 2002/21/EC Directive 2002/20/EC Directive 2002/19/EC Directive 2002/22/EC This Directive Article 1(1), (2) and (3) Article 1(1), (2) and (3) Article 1(3a) Article 1(4) Article 1(4) and (5) Article 1(5) and (6) Point (a) of Article 2 Point (1) of Article 2 — — — — Point (2) of Article 2 Point (b) of Article 2 Point (3) of Article 2 Point (c) of Article 2 Point (4) of Article 2 — — — — Point (5) of Article 2 — — — — Point (6) of Article 2 — — — — Point (7) of Article 2 Point (d) of Article 2 Point (8) of Article 2 Point (da) of Article 2 Point (9) of Article 2 Point (e) of Article 2 Point (10) of Article 2 Point (ea) of Article 2 Point (11) of Article 2 Point (f) of Article 2 Point (12) of Article 2 Point (g) of Article 2 — Point (h) of Article 2 Point (13) of Article 2 Point (i) of Article 2 Point (14) of Article 2 Point (j) of Article 2 — Point (k) of Article 2 — Point (l) of Article 2 — Point (m) of Article 2 Point (15) of Article 2 Point (n) of Article 2 Point (16) of Article 2 Point (o) of Article 2 Point (17) of Article 2 Point (p) of Article 2 Point (18) of Article 2 Point (q) Article 2 Point (19) of Article 2 Point (r) Article 2 Point (20) of Article 2 Point (s) Article 2 Point (31) of Article 2 — — — — Point (22) of Article 2 Article 3(1) Article 5(1) — — — — Article 5(2) Article 3(2) Article 6(1) Article 3(3) Article 6(2) Article 3(3a) first subparagraph Article 8(1) — — — — Article 8(2) — — — — Article 7(1) Article 3(3a) second subparagraph Article 7(2) and (3) Article 3(3a) third subparagraph Article 9(1) and (3) — — — — Article 9(2) Article 3(3b) Article 10(1) Article 3(3c) Article 10(2) Article 3(4) Article 5(3) Article 3(5) Article 11 Article 3(6) Article 5(4) Article 4 Article 31 Article 5 Article 20 — — — — Article 22 Article 6 Article 23 Article 7 Article 32 Article 7a Article 33 — — — — Point (c) of Article 33(5) Article 8(1) and (2) Article 3(1) and (2) Article 8(5) Article 3(3) Article 8a(1) and (2) Article 4(1) and (2) — — — — Article 4(3) Article 8a(3) Article 4(4) — — — — Article 29 Article 9(1) and (2) Article 45(1) and (2) — — — — Article 45(3) Article 9(3) Article 45(4) Article 9(4) and (5) Article 45(5) and (6) Article 9(6) and (7) — Article 9a — Article 9b(1) and (2) Article 51(1) and (2) Article 9b(3) Article 51(4) — — — — Article 51(3) Article 10(1) Article 95(1) Article 10(2) Article 95(3) — — — — Article 95(2) — — — — Article 95(4) — — — — Article 95(5) — — — — Article 95(6) Article 10(3) Article 95(7) Article 10(4) Article 95(8) Article 10(5) — Article 11 Article 43 Article 12(1) Article 44(1) Article 12(2) — Article 12(3) Article 61(2) Article 12(4) — Article 12(5) Article 44(2) Article 13 Article 17 Article 13a(1), (2) and (3) Article 40(1), (2) and (3) Article 13a(4) — — Article 40(5) — — — — Article 40(4) Article 13b(1), (2) and (3) Article 41(1), (2) and (3) — — — — Article 41(4) Article 13b(4) Article 41(7) — — — — Article 41(5) — — — — Article 41(6) Article 14 Article 63 Article 15(1),(2),(3) Article 64(1), (2), (3) Article 15 (4) — — — — — — — — Article 66 Article 16 Article 67 Article 17 Article 39 Article 18 — Article 19 Article 38 Article 20 Article 26 Article 21(1) Article 27(1) Article 21(2) first and second subparagraphs Article 27(2) Article 21(2) third subparagraph Article 27(3) Article 21(2) fourth and fifth subparagraphs Article 27(4) — Article 27(5) Article 21(3) — Article 21(4) Article 27(6) Article 21a Article 29 Article 22(1) Article 118(1) Article 22(2) Article 118(3) Article 22(3) Article 118(4) — — — — Article 11(2) — — — — Article 118(5) — — — — Article 117 Article 23 Article 119 Article 24 Article 120(1) and (2) Article 25 Article 122(1) Article 26 Article 125 Article 28 Article 124 Article 29 Article 127 Article 30 Article 128 Annex II — Article 1 Article 1(1) Article 2(1) — Article 2(2) Point (22) of Article 2 — — — — Point (23) of Article 2 — — — — Point (24) of Article 2 — — — — Point (25) of Article 2 — — — — Point (26) of Article 2 Article 3(1) Article 12(1) Article 3(2) first sentence Article 12(2) Article 3(2) 2nd, 3rd and 4th sentences Article 12(3) Article 3(3) Article 12(4) — — — — Article 4 Article 15 Article 5(1) Article 46(1) — — — — Article 46(2) and (3) Article 5(2) first subparagraph Article 48(1) Article 5(2) second subparagraph first sentence Article 48(2) Article 5(2) third subparagraph Article 48(5) Article 5(2) second subparagraph second sentence Article 48(3) — — — — Article 48(4) Article 5(3) Article 48(6) Article 5(4) and (5) Article 93(4) and (5) Article 5(6) Article 52 — — — — Article 93 Article 6(1),(2),(3) and (4) Article 13 — — — — Article 47 Article 7 — — Article 55 Article 8 Article 36 Article 9 Article 14 Article 10 Article 30 — — — — Article 11 Article 21 Article 12 Article 16 Article 13 Article 42 — — — — Article 94 Article 14(1) Article 18 Article 14(2) Article 19 Article 15 Article 120(3) and (4) Article 16 — Article 17 — Article 18 — Article 19 — Article 20 — Annex Annex I Article 1 (1 and 2) Article 1(2) and (3) Point (a) of Article 2 Point (27) of Article 2 Point (b) of Article 2 Point (28) of Article 2 Point (c) of Article 2 Point (29) of Article 2 Point (d) of Article 2 — Point (e) of Article 2 Point (30) of Article 2 Article 3 Article 59 Article 4 Article 60 Article 5 Article 61 Article 6 Article 62 — Article 8 Article 68 Article 9 Article 69 Article 10 Article 70 Article 11 Article 71 — — — — Article 72 Article 12 Article 73 Article 13 Article 74 — — — — Article 75 — — — — Article 76 Article 13a Article 77 Article 13b Article 78 — — — — Article 80 — — — — Article 81 Article 14 — Article 15 Article 120(5) Article 16(1) — Article 16(2) Article 121(4) Article 17 — Article 18 — Article 19 — Article 20 — Annex I Annex II Annex II — — — — — Annex III Article 1 Article 1(4) and (5) Point (a) of Article 2 — Point (c) of Article 2 Point (32) of Article 2 Point (d) of Article 2 Point (33) of Article 2 Point (f) of Article 2 Point (34) of Article 2 — — — — Point (35) of Article 2 — — — — Point (37) of Article 2 — — — — Point (38) of Article 2 — — — — Point (39) of Article 2 — — — — Article 84 — — — — Article 85 Article 3 Article 86(1) and (2) Article 4 — Article 5 — Article 6 — Article 7 — Article 8(1) Article 86(3) Article 8(2) Article 86(4) Article 8(3) Article 86(5) Article 9 — — — — — Article 87 Article 10 Article 88 Article 11 — Article 12 Article 89 Article 13 Article 90 Article 14 Article 91 Article 15 Article 122(2) and (3) Article 17 — — — — — Article 99 — — — — Article 101 Article 20(1) Article 102 Article 20(2) Article 105(3) Article 21 Article 103 Article 22 Article 104 Article 23 Article 108 Article 23a Article 111 Article 24 Article 113 Article 25 Article 112 Article 26 Article 109 Article 27 — Article 27a Article 96 Article 28 Article 97 Article 29 Article 115 Article 30(1) Article 106(2) Article 30(2) Article 106(4) Article 30(3) Article 106(4) Article 30(4) Article 106(5) Article 30(5) Article 105(1) Article 31 Article 114 Article 32 Article 92 Article 33 Article 24 Article 34 Article 25 Article 35 Article 116 Article 36 Article 121 Article 37 — Article 38 — Article 39 — Article 40 — Annex I Annex V Annex II Annex VII Annex III Annex IX Annex IV Annex VI Annex V — Annex VI Annex X Annex IV

European Electronic Communications Code European Electronic Communications Code SUMMARY OF: Directive (EU) 2018/1972 establishing the European Electronic Communications Code WHAT IS THE AIM OF THE DIRECTIVE? The directive: establishes a set of updated rules to regulate electronic communications (telecoms) networks, telecoms services, and associated facilities and services; sets out tasks for national regulatory authorities and other competent authorities, and establishes a set of procedures to ensure that the regulatory framework is harmonised throughout the EU; aims to stimulate competition and increased investment in 5G* and very high capacity networks, so that every citizen and business in the EU can enjoy high quality connectivity, a high level of consumer protection and an increased choice of innovative digital services. KEY POINTS The directive establishes a European Electronic Communications Code, a comprehensive set of new or revised rules for the telecoms sector as part of a package of telecom laws, including Regulation (EU) 2018/1971 establishing the Body of European Regulators for Electronic Communications (BEREC) and the Agency for Support for BEREC (BEREC Office). It replaces and repeals Directives 2002/19/EC, 2002/20/EC and 2002/21/EC, as well as Article 5 of Decision No 243/2012/EU. The review of Directive 2002/58/EC (Directive on privacy and electronic communications) is carried out separately. General objectives promote connectivity and take-up of very high capacity networks, including fixed, mobile and wireless networks, for all EU citizens and businesses; promote the interests of EU citizens by enabling maximum benefits in terms of choice, price and quality through effective competitionmaintaining network and services securityensuring protection for consumers through specific rules andaddressing the needs of specific social groups, in particular people with disabilities, older people and people with special social needs; facilitate market entry and promote competition in the delivery of telecoms networks and associated facilities; contribute to the development of the internal market in telecoms networks and services in the EU, by developing common rules and predictable regulation featuring: the effective, efficient and coordinated use of radio spectrum;open innovation;the development of trans-European networks;the availability and interoperability of Europe-wide services; andend-to-end connectivity. Responsibility of EU countries cooperate with each other and with the European Commission in the strategic planning and coordination of radio spectrum policy, avoiding harmful interference, through the Radio Spectrum Policy Group; ensure that tasks set out in the directive are undertaken by a competent authority; guarantee that national regulatory authorities and other competent authorities are independent of telecoms equipment manufacturers and service providers; ensure that the national regulatory authorities are protected against external intervention or political pressure which mightjeopardise their independent assessment andhave budget autonomy and adequate financial and human resources to carry out the tasks assigned to them. New objectives and tasks In addition to replacing and repealing existing legislation, the directive introduces a series of new objectives and tasks: Strengthened consumer rules aim to make it easier to switch between service providers and offer better protection, for example, for people who subscribe to bundled services. Consumers will benefit from a similar, higher level of protection across the EU. Telecoms services now include services provided over the internet which do not use calling numbers, such as messaging apps and email. A review mechanism aims to ensure that consumerrights remain robust and up-to-date as business models and consumer behaviour change. Affordable and adequate broadband internet access must be available to all consumers, irrespective of their location or income. People with disabilities should have equivalent access to telecoms services. EU countries will set up a public warning system to send alerts to citizens on their mobile phones in the event of a natural disaster or other major emergency in their area. EU countries must provide operators with predictable regulationfor radio spectrum licensing for wireless broadband for at least 20 years to promote investment, in particular in 5G connectivity; increased convergence of national selection procedures through a Peer Review Forum. New frequency bands for 5G connectivity for faster internet connections and better connectivity, as well as coordinated timing of spectrum licensing and a lighter regulatory regime for small mobile network equipment deployment. Rules on operator access to networks to encourage competition make it easier for companies to invest in new, very high capacity infrastructure (download speeds of 100 Mbps or more), including in remote areas, while ensuring effective market regulation. New tools will address issues that may arise in certain market circumstances. Symmetric regulation* will apply to electronic communications network providers in some very specific situations to ensure competition. FROM WHEN DOES THIS DIRECTIVE APPLY? It entered into force on 20 December 2018. Directive (EU) 2018/1972 recasts and replaces Directives 2002/19/EC, 2002/20/EC and 2002/21/EC (and their subsequent amendments) which had to become law in the EU countries by 2003. The new rules contained in Directive (EU) 2018/1972 apply and have to become law in the EU countries by 21 December 2020 BACKGROUND See also: Press release on EU’s telecoms rules (European Commission) Political agreement on the rules shaping the telecommunication markets in the 5G era (European Commission) Factsheet: Spectrum in the EU (European Commission) Factsheet: More and better internet connectivity requires investments in high speed and quality networks (European Commission) Digital Economy and Society Index (DESI) (European Commission) Connectivity for a European Gigabit Society (European Commission) Electronic communications laws (European Commission). KEY TERMS 5G: the latest generation of cellular mobile communication, characterised by a high data rate, reduced latency, energy saving, cost reduction, higher system capacity and greater device connectivity. Symmetric regulation: the same regulation of all network providers (as opposed to asymmetric regulation which differentiates between providers, generally to provide a level playing field between providers of lesser and greater importance). MAIN DOCUMENT Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (Recast) (OJ L 321, 17.12.2018, pp. 36-214) RELATED DOCUMENTS Regulation (EU) 2018/1971 of the European Parliament and of the Council of 11 December 2018 establishing the Body of European Regulators for Electronic Communications (BEREC) and the Agency for Support for BEREC (BEREC Office), amending Regulation (EU) 2015/2120 and repealing Regulation (EC) No 1211/2009 (OJ L 321, 17.12.2018, pp. 1-35) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, pp. 1-30) Regulation (EU) 2015/2120 of the European Parliament and of the Council of 25 November 2015 laying down measures concerning open internet access and amending Directive 2002/22/EC on universal service and users’ rights relating to electronic communications networks and services and Regulation (EU) No 531/2012 on roaming on public mobile communications networks within the Union (OJ L 310, 26.11.2015, pp. 1-18) Successive amendments to Regulation (EU) 2015/2120 have been incorporated into the original document. This consolidated version is of documentary value only. Regulation (EU) 2015/758 of the European Parliament and of the Council of 29 April 2015 concerning type-approval requirements for the deployment of the eCall in-vehicle system based on the 112 service and amending Directive 2007/46/EC (OJ L 123, 19.5.2015, pp. 77-89) See consolidated version. Directive 2014/61/EU of the European Parliament and of the Council of 15 May 2014 on measures to reduce the cost of deploying high-speed electronic communications networks (OJ L 155, 23.5.2014, pp. 1-14) Regulation (EU) No 531/2012 of the European Parliament and of the Council of 13 June 2012 on roaming on public mobile communications networks within the Union (OJ L 172, 30.6.2012, pp. 10-35) See consolidated version. Decision No 243/2012/EU of the European Parliament and of the Council of 14 March 2012 establishing a multiannual radio spectrum policy programme (OJ L 81, 21.3.2012, pp. 7-17) Decision No 676/2002/EC of the European Parliament and of the Council of 7 March 2002 on a regulatory framework for radio spectrum policy in the European Community (Radio Spectrum Decision) (OJ L 108, 24.4.2002, pp. 1-6) Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities (Access Directive) (OJ L 108, 24.4.2002, pp. 7-20) See consolidated version. Directive 2002/20/EC of the European Parliament and of the Council of 7 March 2002 on the authorisation of electronic communications networks and services (Authorisation Directive) (OJ L 108, 24.4.2002, pp. 21-32) See consolidated version. Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive) (OJ L 108, 24.4.2002, pp. 33-50) See consolidated version. Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, pp. 37-47) See consolidated version. last update 05.06.2019

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5.5.2017 EN Official Journal of the European Union L 117/176 REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Directive 98/79/EC of the European Parliament and of the Council (3) constitutes the Union regulatory framework for in vitro diagnostic medical devices. However, a fundamental revision of that Directive is needed to establish a robust, transparent, predictable and sustainable regulatory framework for in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation. (2) This Regulation aims to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on the market and putting into service of in vitro diagnostic medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods. As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for in vitro diagnostic medical devices by ensuring, among other things, that data generated in performance studies are reliable and robust and that the safety of subjects participating in performance studies is protected. (3) This Regulation does not seek to harmonise rules relating to the further making available on the market of in vitro diagnostic medical devices after they have already been put into service, such as in the context of second-hand sales. (4) Key elements of the existing regulatory approach, such as the supervision of notified bodies, risk classification, conformity assessment procedures, performance evaluation and performance studies, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding in vitro diagnostic medical devices should be introduced, to improve health and safety. (5) To the extent possible, guidance developed for in vitro diagnostic medical devices at international level, in particular in the context of the Global Harmonization Task Force and its follow-up initiative, the International Medical Devices Regulators Forum, should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical documentation, classification rules, conformity assessment procedures and clinical evidence. (6) There are specific features of in vitro diagnostic medical devices, in particular in terms of risk classification, conformity assessment procedures and clinical evidence, and of the in vitro diagnostic medical device sector which require the adoption of specific legislation, distinct from the legislation on other medical devices, whereas the horizontal aspects common to both sectors should be aligned. (7) The scope of application of this Regulation should be clearly delimited from other legislation concerning products, such as medical devices, general laboratory products and products for research use only. (8) It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regard across all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own initiative or at the duly substantiated request of a Member State, having consulted the Medical Device Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of this Regulation. When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation of the European Medicines Agency, the European Chemicals Agency and the European Food Safety Authority, as relevant. (9) It appears that it is possible that divergent national rules regarding the provision of information and counselling in relation to genetic testing might only have an impact on the smooth functioning of the internal market to a limited extent. Therefore, it is appropriate to lay down only limited requirements in this regard in this Regulation, having regard to the need to ensure constant respect of the principles of proportionality and subsidiarity. (10) It should be made clear that all tests that provide information on the predisposition to a medical condition or a disease, such as genetic tests, and tests that provide information to predict treatment response or reactions, such as companion diagnostics, are in vitro diagnostic medical devices. (11) Companion diagnostics are essential for defining patients' eligibility for specific treatment with a medicinal product through the quantitative or qualitative determination of specific markers identifying subjects at a higher risk of developing an adverse reaction to the medicinal product in question or identifying patients in the population for whom the therapeutic product has been adequately studied, and found safe and effective. Such biomarker or biomarkers can be present in healthy subjects and/or in patients. (12) Devices that are used with a view to monitoring treatment with a medicinal product in order to ensure that the concentration of relevant substances in the human body is within the therapeutic window are not considered to be companion diagnostics. (13) The requirement to reduce risks as far as possible should be fulfilled taking into account the generally acknowledged state of the art in the field of medicine. (14) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (4) are an integral part of the general safety and performance requirements laid down in this Regulation for devices. Consequently, this Regulation should be considered a lex specialis in relation to that Directive. (15) This Regulation should include requirements regarding the design and manufacture of devices emitting ionizing radiation without affecting the application of Council Directive 2013/59/Euratom (5) which pursues other objectives. (16) This Regulation should include requirements for devices' safety and performance characteristics which are developed in such a way as to prevent occupational injuries, including protection from radiation. (17) It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of an in vitro diagnostic medical device, qualifies as an in vitro diagnostic medical device, while software for general purposes, even when used in a healthcare setting, or software intended for well-being purposes is not an in vitro diagnostic medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device. (18) The definitions in this Regulation regarding the devices themselves, the making available of devices, economic operators, users and specific processes, the conformity assessment, clinical evidence, post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should be aligned with well-established practice in the field at Union and international level in order to enhance legal certainty. (19) It should be made clear that it is essential that devices offered to persons in the Union by means of information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council (6) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union comply with the requirements of this Regulation, where the product in question is placed on the market or the service is provided in the Union. (20) To recognise the important role of standardisation in the field of in vitro diagnostic medical devices, compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (7) should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements, such as those relating to quality and risk management, laid down in this Regulation. (21) Directive 98/79/EC allows the Commission to adopt common technical specifications for specific categories of in vitro diagnostic medical devices. In areas where no harmonised standards exist or where they are insufficient, the Commission should be empowered to lay down common specifications which provide a means of complying with the general safety and performance requirements and the requirements for performance studies and performance evaluation and/or post-market follow-up, laid down in this Regulation. (22) Common specifications (‘CS’) should be developed after consulting the relevant stakeholders and taking account of the European and international standards. (23) The rules applicable to devices should be aligned, where appropriate, with the New Legislative Framework for the Marketing of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the Council (8) and Decision No 768/2008/EC of the European Parliament and of the Council (9). (24) The rules on Union market surveillance and control of products entering the Union market laid down in Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States from choosing the competent authorities to carry out those tasks. (25) It is appropriate to set out clearly the general obligations of the different economic operators, including importers and distributors, building on the New Legislative Framework for the Marketing of Products, without prejudice to the specific obligations laid down in the various parts of this Regulation, to enhance understanding of the requirements laid down in this Regulation and thus to improve regulatory compliance by the relevant operators. (26) For the purpose of this Regulation, the activities of distributors should be deemed to include acquisition, holding and supplying of devices. (27) Several of the obligations on manufacturers, such as performance evaluation or vigilance reporting, that were set out only in the Annexes to Directive 98/79/EC, should be incorporated into the enacting provisions of this Regulation to facilitate its application. (28) To ensure the highest level of health protection, the rules governing in vitro diagnostic medical devices, manufactured and used within a single health institution only, should be clarified and strengthened. That use should be understood to include measurement and delivery of results. (29) Health institutions should have the possibility of manufacturing, modifying and using devices in-house and thereby addressing, on a non-industrial scale, the specific needs of target patient groups which cannot be met at the appropriate level of performance by an equivalent device available on the market. In that context, it is appropriate to provide that certain rules of this Regulation, as regards devices manufactured and used only within health institutions, including hospitals as well as institutions, such as laboratories and public health institutes that support the health care system and/or address patient needs, but which do not treat or care for patients directly, should not apply, since the aims of this Regulation would still be met in a proportionate manner. It should be noted that the concept of ‘health institution’ does not cover establishments primarily claiming to pursue health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a result, the exemption applicable to health institutions does not apply to such establishments. (30) In view of the fact that natural or legal persons can claim compensation for damage caused by a defective device in accordance with applicable Union and national law, it is appropriate to require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability under Council Directive 85/374/EEC (10). Such measures should be proportionate to the risk class, type of device and the size of the enterprise. In this context, it is also appropriate to lay down rules concerning the facilitation, by a competent authority, of the provision of information to persons who may have been injured by a defective device. (31) To ensure that devices manufactured in series production continue to be in conformity with the requirements of this Regulation and that experience from the use of the devices they manufacture is taken into account for the production process, all manufacturers should have a quality management system and a post-market surveillance system in place which should be proportionate to the risk class and the type of the device in question. In addition, in order to minimize risks or prevent incidents related to devices, manufacturers should establish a system for risk management and a system for reporting incidents and field safety corrective actions. (32) The risk management system should be carefully aligned with and reflected in the performance evaluation process for the device, including the clinical risks to be addressed as part of performance studies, performance evaluation and post-market performance follow-up. The risk management and performance evaluation processes should be inter-dependent and should be regularly updated. (33) It should be ensured that supervision and control of the manufacture of devices, as well as post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer's organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification. (34) For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations. The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer. The tasks of an authorised representative should be defined in a written mandate. Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer's person responsible for regulatory compliance. (35) To ensure legal certainty in respect of the obligations incumbent on economic operators, it is necessary to clarify when a distributor, importer or other person is to be considered the manufacturer of a device. (36) Parallel trade in products already placed on the market is a lawful form of trade within the internal market on the basis of Article 34 TFEU subject to the limitations arising from the need for protection of health and safety and from the need for protection of intellectual property rights provided for under Article 36 TFEU. Application of the principle of parallel trade is, however, subject to different interpretations in the Member States. The conditions, in particular the requirements for relabelling and repackaging, should therefore be specified in this Regulation, taking into account the case-law of the Court of Justice (11) in other relevant sectors and existing good practice in the field of in vitro diagnostic medical devices. (37) Devices should, as a general rule, bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the Union and be put into service in accordance with their intended purpose. Member States should not create obstacles to the placing on the market or putting into service of devices that comply with the requirements laid down in this Regulation. However, Member States should be allowed to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation. (38) The traceability of devices by means of a Unique Device Identification system (UDI system) based on international guidance should significantly enhance the effectiveness of the post-market safety-related activities for devices, which is owing to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against falsified devices. Use of the UDI system should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators and, where possible, be compatible with other authentication systems already in place in those settings. (39) The UDI system should apply to all devices placed on the market except devices for performance studies, and be based on internationally recognised principles including definitions that are compatible with those used by major trade partners. In order for the UDI system to become functional in time for the application of this Regulation, detailed rules should be laid down in this Regulation and in Regulation (EU) 2017/745 of the European Parliament and of the Council (12). (40) Transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system. (41) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical devices (Eudamed) that should integrate different electronic systems to collate and process information regarding devices on the market and the relevant economic operators, certain aspects of conformity assessment, notified bodies, certificates, performance studies, vigilance and market surveillance. The objectives of the database are to enhance overall transparency, including through better access to information for the public and healthcare professionals, to avoid multiple reporting requirements, to enhance coordination between Member States and to streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission. Within the internal market, this can be ensured effectively only at Union level and the Commission should therefore further develop and manage the European databank on medical devices set up by Commission Decision 2010/227/EU (13). (42) To facilitate the functioning of Eudamed, an internationally recognised medical device nomenclature should be available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. Furthermore, that nomenclature should be available, where reasonably practicable, free of charge also to other stakeholders. (43) Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public to be adequately informed about devices on the Union market. The electronic system on performance studies should serve as a tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and to report serious adverse events, device deficiencies and related updates. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of the evaluation of such incidents and events by competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities. (44) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the European Parliament and of the Council (14) applies to the processing of personal data carried out in the Member States, under the supervision of the Member States' competent authorities, in particular the public independent authorities designated by the Member States. Regulation (EC) No 45/2001 of the European Parliament and of the Council (15) applies to the processing of personal data carried out by the Commission within the framework of this Regulation, under the supervision of the European Data Protection Supervisor. In accordance with Regulation (EC) No 45/2001, the Commission should be designated as the controller of Eudamed and its electronic systems. (45) For class C and D devices, manufacturers should summarise the main safety and performance aspects of the device and the outcome of the performance evaluation in a document that should be publicly available. (46) The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and citizens' confidence in the system. Designation and monitoring of notified bodies by the Member States, in accordance with detailed and strict criteria, should therefore be subject to controls at Union level. (47) Notified bodies' assessments of manufacturers' technical documentation, in particular documentation on performance evaluation, should be critically evaluated by the authority responsible for notified bodies. That evaluation should be part of the risk-based approach to the oversight and monitoring activities of notified bodies and should be based on sampling of the relevant documentation. (48) The position of notified bodies vis-à-vis manufacturers should be strengthened, including with regard to their right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to ensure continuous compliance by manufacturers after receipt of the original certification. (49) To increase transparency with regard to the oversight of notified bodies by national authorities, the authorities responsible for notified bodies should publish information on the national measures governing the assessment, designation and monitoring of notified bodies. In accordance with good administrative practice, this information should be kept up to date by those authorities in particular to reflect relevant, significant or substantive changes to the procedures in question. (50) The Member State in which a notified body is established should be responsible for enforcing the requirements of this Regulation with regard to that notified body. (51) In view, in particular, of the responsibility of Member States for the organisation and delivery of health services and medical care, they should be allowed to lay down additional requirements on notified bodies designated for the conformity assessment of devices and established on their territory as far as issues that are not regulated in this Regulation are concerned. Any such additional requirements laid down should not affect more specific horizontal Union legislation on notified bodies and equal treatment of notified bodies. (52) For class D devices, competent authorities should be informed about certificates granted by notified bodies and be given the right to scrutinise the assessment conducted by notified bodies. (53) For class D devices for which no CS exist it is appropriate to provide that where it is the first certification for that specific type of device and there is no similar device on the market having the same intended purpose and based on similar technology, notified bodies should, in addition to the laboratory testing of the performance claimed by the manufacturer and the compliance of the device by the EU reference laboratories, be obliged to request expert panels to scrutinise their performance evaluation assessment reports. The consultation of expert panels in relation to the performance evaluation should lead to a harmonised evaluation of high-risk in vitro diagnostic medical devices by sharing expertise on performance aspects and developing CS on categories of devices that have undergone that consultation process. (54) To enhance patient safety and to take due account of technological progress, the current classification system for devices set out in Directive 98/79/EC should be fundamentally changed, in line with international practice, and the corresponding conformity assessment procedures should be accordingly adapted. (55) It is necessary, in particular for the purpose of the conformity assessment procedures, to classify devices in four risk classes and to establish a set of robust risk-based classification rules, in line with international practice. (56) The conformity assessment procedure for class A devices should be carried out, as a general rule, under the sole responsibility of manufacturers, since such devices pose a low risk to patients. For class B, class C and class D devices, an appropriate level of involvement of a notified body should be compulsory. (57) The conformity assessment procedures for devices should be further strengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field. (58) It is appropriate that certificates of free sale contain information that makes it possible to use Eudamed in order to obtain information on the device, in particular with regard to whether it is on the market, withdrawn from the market or recalled, and on any certificate on its conformity. (59) It is necessary to clarify the requirements regarding batch release verification for the highest risk devices. (60) EU reference laboratories should be enabled to verify by laboratory testing the performance claimed by the manufacturer and the compliance of devices presenting the highest risk with the applicable CS, when such CS are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. (61) To ensure a high level of safety and performance, demonstration of compliance with the general safety and performance requirements laid down in this Regulation should be based on clinical evidence. It is necessary to clarify the requirements for the demonstration of the clinical evidence, that is based on data on scientific validity, and the analytical performance and clinical performance of the device. To allow for a structured and transparent process, generating reliable and robust data, sourcing and assessment of available scientific information and data generated in performance studies should be based on a performance evaluation plan. (62) As a general rule, clinical evidence should be sourced from performance studies that have been carried out under the responsibility of a sponsor. It should be possible both for the manufacturer and for another natural or legal person to be the sponsor taking responsibility for the performance study. (63) It is necessary to ensure that the clinical evidence of devices is updated throughout their lifecycle. Such updating entails the planned monitoring of scientific developments and changes in medical practice by the manufacturer. Relevant new information should then trigger a reassessment of the clinical evidence of the device thus ensuring safety and performance through a continuous process of performance evaluation. (64) It should be recognised that the concept of clinical benefit for in vitro diagnostic medical devices is fundamentally different from that which applies in the case of pharmaceuticals or of therapeutic medical devices, since the benefit of in vitro diagnostic medical devices lies in providing accurate medical information on patients, where appropriate, assessed against medical information obtained through the use of other diagnostic options and technologies, whereas the final clinical outcome for the patient is dependent on further diagnostic and/or therapeutic options which could be available. (65) Where specific devices have no analytical or clinical performance or specific performance requirements are not applicable, it is appropriate to justify in the performance evaluation plan, and related reports, omissions relating to such requirements. (66) The rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects, so as to make it easier for the results of performance studies conducted in the Union to be accepted as documentation outside the Union and to make it easier for the results of performance studies conducted outside the Union in accordance with international guidelines to be accepted within the Union. In addition, the rules should be in line with the most recent version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects. (67) It should be left to the Member State where a performance study is to be conducted to determine the appropriate authority to be involved in the assessment of the application to conduct a performance study and to organise the involvement of ethics committees within the timelines for the authorisation of that performance study as set out in this Regulation. Such decisions are a matter of internal organisation for each Member State. In that context, Member States should ensure the involvement of laypersons, in particular patients or patients' organisations. They should also ensure that the necessary expertise is available. (68) An electronic system should be set up at Union level to ensure that every interventional clinical performance study and other performance study involving risks for the subjects of the studies is recorded and reported in a publicly accessible database. To protect the right to protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union (‘the Charter’), no personal data of subjects participating in a performance study should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on performance studies should be interoperable with the EU database to be set up for clinical trials on medicinal products for human use. (69) Where an interventional clinical performance study or another performance study involving risks for the subjects is to be conducted in more than one Member State, the sponsor should have the possibility of submitting a single application in order to reduce administrative burden. In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety-related aspects of the device for performance study and of the scientific design of that performance study, the procedure for the assessment of such single application should be coordinated between the Member States under the direction of a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically national, local and ethical aspects of a performance study, including informed consent. For an initial period of seven years from the date of application of this Regulation, Member States should be able to participate on a voluntary basis in the coordinated assessment. After that period, all Member States should be obliged to participate in the coordinated assessment. The Commission, based on the experience gained from the voluntary coordination between Member States, should draw up a report on the application of the relevant provisions regarding the coordinated assessment procedure. In the event that the findings of the report are negative, the Commission should submit a proposal to extend the period of participation on a voluntary basis in the coordinated assessment procedure. (70) Sponsors should report certain adverse events and device deficiencies that occur during interventional clinical performance studies and other performance studies involving risks for the subjects to the Member States in which those studies are being conducted. Member States should have the possibility of terminating or suspending the studies or revoking the authorisation for those studies, if considered necessary to ensure a high level of protection of the subjects participating in such studies. Such information should be communicated to the other Member States. (71) The sponsor of a performance study should submit a summary of results of the performance study that is easily understandable for the intended user together with the performance study report, where applicable, within the timelines laid down in this Regulation. Where it is not possible to submit the summary of the results within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results will be submitted. (72) With exemption of some general requirements, this Regulation should only cover performance studies intended to gather scientific data for the purpose of demonstrating conformity of devices. (73) It is necessary to clarify that performance studies using left-over specimens need not be authorised. Nevertheless, the general requirements and other additional requirements with regard to data protection and the requirements applicable to procedures that are performed in accordance with national law such as ethical review should continue to apply to all performance studies, including when using left-over specimens. (74) The principles of replacement, reduction and refinement in the area of animal experimentation laid down in the Directive 2010/63/EU of the European Parliament and the Council (16) should be observed. In particular, the unnecessary duplication of tests and studies should be avoided. (75) Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national competent authorities in charge of vigilance and market surveillance activities. To that end, manufacturers should establish a comprehensive post-market surveillance system, set up under their quality management system and based on a post-market surveillance plan. Relevant data and information gathered through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective actions, should be used to update any relevant part of technical documentation, such as those relating to risk assessment and performance evaluation, and should also serve the purposes of transparency. (76) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance for devices should be made more effective by creating a central portal at Union level for reporting serious incidents and field safety corrective actions. (77) Member States should take appropriate measures to raise awareness among healthcare professionals, users and patients about the importance of reporting incidents. Healthcare professionals, users and patients should be encouraged and enabled to report suspected serious incidents at national level using harmonised formats. The national competent authorities should inform manufacturers of any suspected serious incident and, where a manufacturer confirms that such an incident might have occurred, the authorities concerned should ensure that appropriate follow-up action is taken in order to minimise recurrence of such incidents. (78) The evaluation of reported serious incidents and field safety corrective actions should be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corrective actions have to be carried out in more than one Member State, with the objective of sharing resources and ensuring consistency regarding the corrective action. (79) In the context of the investigation of incidents, the competent authorities should take into account, where appropriate, the information provided by and views of relevant stakeholders, including patient and healthcare professionals' organisations and manufacturers' associations. (80) The reporting of serious adverse events or device deficiencies during interventional clinical performance studies and other performance studies involving risks for the subjects, and the reporting of serious incidents occurring after a device has been placed on the market should be clearly distinguished to avoid double reporting. (81) Rules on market surveillance should be included in this Regulation to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures. (82) Any statistically significant increase in the number or severity of incidents that are not serious or in expected erroneous results that could have a significant impact on the benefit-risk analysis and which could lead to unacceptable risks should be reported to the competent authorities in order to permit their assessment and the adoption of appropriate measures. (83) An expert committee, the MDCG, composed of persons designated by the Member States based on their role and expertise in the field of medical devices including in vitro diagnostic medical devices, should be established in accordance with the conditions and modalities defined in Regulation (EU) 2017/745 to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) 2017/745, to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation. The MDCG should be able to establish subgroups in order to have access to necessary in-depth technical expertise in the field of medical devices including in vitro diagnostic medical devices. When establishing subgroups, appropriate consideration should be given to the possibility of involving existing groups at Union level in the field of medical devices. (84) Closer coordination between national competent authorities through information exchange and coordinated assessments under the direction of a coordinating authority is essential for ensuring a uniform high level of health and safety protection within the internal market, in particular in the areas of performance studies and vigilance. The principle of coordinated exchange and assessment should also apply across other authority activities described in this Regulation, such as the designation of notified bodies and should be encouraged in the area of market surveillance of devices. Joint working, coordination and communication of activities should also lead to more efficient use of resources and expertise at national level. (85) The Commission should provide scientific, technical and corresponding logistical support to coordinating national authorities and ensure that the regulatory system for devices is effectively and uniformly implemented at Union level based on sound scientific evidence. (86) The Union and, where appropriate, the Member States should actively participate in international regulatory cooperation in the field of devices to facilitate the exchange of safety-related information regarding devices and foster the further development of international regulatory guidelines that promote the adoption in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that set by this Regulation. (87) Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement. (88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level, Member States should, in order to ensure transparency, inform the Commission and the other Member States before they decide on the level and structure of such fees. In order to further ensure transparency, the structure and level of the fees should be publicly available on request. (89) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter and in particular human dignity, the integrity of the person, the protection of personal data, the freedom of art and science, the freedom to conduct business and the right to property. This Regulation should be applied by the Member States in accordance with those rights and principles. (90) The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in order to amend certain non-essential provisions of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law Making (17). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with preparation of delegated acts. (91) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (18). (92) The advisory procedure should be used for implementing acts that set out the form and presentation of the data elements of manufacturers' summaries of safety and performance, and that establish the model for certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an impact on health and safety at Union level. (93) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the extension to the territory of the Union of a national derogation from the applicable conformity assessment procedures, imperative grounds of urgency so require. (94) In order to enable it to designate issuing entities and EU reference laboratories, implementing powers should be conferred on the Commission. (95) To allow economic operators, especially SMEs, notified bodies, Member States and the Commission to adapt to the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements that are to be made. However, certain parts of the Regulation that directly affect Member States and the Commission should be implemented as soon as possible. It is also particularly important that, by the date of application of this Regulation, a sufficient number of notified bodies be designated in accordance with the new requirements so as to avoid any shortage of devices on the market. Nonetheless, it is necessary that any designation of a notified body in accordance with the requirements of this Regulation prior to the date of its application be without prejudice to the validity of the designation of those notified bodies under Directive 98/79/EC and to their capacity to continue issuing valid certificates under that Directive until the date of application of this Regulation. (96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the obligation to submit the relevant information to the electronic systems set up at Union level pursuant to this Regulation should, in the event that the corresponding IT systems are developed according to plan, only become fully effective from 18 months after the date of application of this Regulation. During this transitional period, certain provisions of Directive 98/79/EC should remain in force. However, in order to avoid multiple registrations, economic operators and notified bodies who register in the relevant electronic systems set up at Union level pursuant to this Regulation should be considered to be in compliance with the registration requirements adopted by the Member States pursuant to those provisions. (97) In order to provide for a smooth introduction of the UDI system, the moment of application of the obligation to place the UDI carrier on the label of the device should vary from one to five years after the date of application of this Regulation depending upon the class of the device concerned. (98) Directive 98/79/EC should be repealed to ensure that only one set of rules applies to the placing of in vitro diagnostic medical devices on the market and the related aspects covered by this Regulation. Manufacturers' obligations as regards the making available of documentation regarding devices they placed on the market and manufacturers' and Member States' obligations as regards vigilance activities for devices placed on the market pursuant to that Directive should however continue to apply. While it should be left to Member States to decide how to organise vigilance activities, it is desirable for them to have the possibility of reporting adverse incidents related to devices placed on the market pursuant to that Directive using the same tools as those for reporting on devices placed on the market pursuant to this Regulation. However, Decision 2010/227/EU adopted in implementation of that Directive and Council Directives 90/385/EEC (19) and 93/42/EEC (20) should also be repealed as from the date when Eudamed becomes fully functional. (99) The requirements of this Regulation should be applicable to all devices placed on the market or put into service from the date of application of this Regulation. However, in order to provide for a smooth transition it should be possible, for a limited period of time from that date, for devices to be placed on the market or put into service by virtue of a valid certificate issued pursuant to Directive 98/79/EC. (100) The European Data Protection Supervisor has given an opinion (21) pursuant to Article 28(2) of Regulation (EC) No 45/2001. (101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the internal market as regards medical devices and to ensure high standards of quality and safety for in vitro diagnostic medical devices, thus ensuring a high level of protection of health and safety of patients, users and other persons, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS REGULATION: CHAPTER I INTRODUCTORY PROVISIONS Section 1 Scope and definitions Article 1 Subject matter and scope 1. This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of in vitro diagnostic medical devices for human use and accessories for such devices in the Union. This Regulation also applies to performance studies concerning such in vitro diagnostic medical devices and accessories conducted in the Union. 2. For the purposes of this Regulation, in vitro diagnostic medical devices and accessories for in vitro diagnostic medical devices shall hereinafter be referred to as ‘devices’. 3. This Regulation does not apply to: (a) products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; (b) invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen; (c) internationally certified reference materials; (d) materials used for external quality assessment schemes. 4. Any device which, when placed on the market or put into service, incorporates, as an integral part, a medical device as defined in point 1 of Article 2 of Regulation (EU) 2017/745 shall be governed by that Regulation. The requirements of this Regulation shall apply to the in vitro diagnostic medical device part. 5. This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU. 6. Devices which are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (22) shall, where a hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those requirements are more specific than the general safety and performance requirements set out in Chapter II of Annex I to this Regulation. 7. This Regulation shall not affect the application of Directive 2013/59/Euratom. 8. This Regulation shall not affect the right of a Member State to restrict the use of any specific type of device in relation to aspects not covered by this Regulation. 9. This Regulation shall not affect national law concerning the organisation, delivery or financing of health services and medical care, such as the requirement that certain devices may only be supplied on a medical prescription, the requirement that only certain health professionals or health care institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling. 10. Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under Article 11 of the Charter of Fundamental Rights of the European Union. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘medical device’ means ‘medical device’ as defined in point (1) of Article 2 of Regulation (EU) 2017/745; (2) ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following: (a) concerning a physiological or pathological process or state; (b) concerning congenital physical or mental impairments; (c) concerning the predisposition to a medical condition or a disease; (d) to determine the safety and compatibility with potential recipients; (e) to predict treatment response or reactions; (f) to define or monitoring therapeutic measures. Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices; (3) ‘specimen receptacle’ means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination; (4) ‘accessory for an in vitro diagnostic medical device’ means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the in vitro diagnostic medical device(s) in terms of its/their intended purpose(s); (5) ‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services; (6) ‘device for near-patient testing’ means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional; (7) ‘companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to: (a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or (b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product; (8) ‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics; (9) ‘single-use device’ means a device that is intended to be used during a single procedure; (10) ‘falsified device’ means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights; (11) ‘kit’ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof; (12) ‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation; (13) ‘label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices; (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken; (15) ‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market; (16) ‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm; (17) ‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer; (18) ‘compatibility’ is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to: (a) perform without losing or compromising the ability to perform as intended, and/or (b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or (c) be used together without conflict/interference or adverse reaction; (19) ‘interoperability’ is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to: (a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or (b) communicate with each other, and/or (c) work together as intended; (20) ‘making available on the market’ means any supply of a device, other than a device for performance study, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (21) ‘placing on the market’ means the first making available of a device, other than a device for performance study, on the Union market; (22) ‘putting into service’ means the stage at which a device, other than a device for performance study, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose; (23) ‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark; (24) ‘fully refurbishing’, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device; (25) ‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation; (26) ‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market; (27) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service; (28) ‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor; (29) ‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health; (30) ‘user’ means any healthcare professional or lay person who uses a device; (31) ‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline; (32) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled; (33) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection; (34) ‘notified body’ means a conformity assessment body designated in accordance with this Regulation; (35) ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing; (36) ‘clinical evidence’ means clinical data and performance evaluation results, pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer; (37) ‘clinical benefit’ means the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health; (38) ‘scientific validity of an analyte’ means the association of an analyte with a clinical condition or a physiological state; (39) ‘performance of a device’ means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose; (40) ‘analytical performance’ means the ability of a device to correctly detect or measure a particular analyte; (41) ‘clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user; (42) ‘performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device; (43) ‘performance study plan’ means a document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study; (44) ‘performance evaluation’ means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device; (45) ‘device for performance study’ means a device intended by the manufacturer to be used in a performance study. A device intended to be used for research purposes, without any medical objective, shall not be deemed to be a device for performance study; (46) ‘interventional clinical performance study’ means a clinical performance study where the test results may influence patient management decisions and/or may be used to guide treatment; (47) ‘subject’ means an individual who participates in a performance study and whose specimen(s) undergo in vitro examination by a device for performance study and/or by a device used for control purposes; (48) ‘investigator’ means an individual responsible for the conduct of a performance study at a performance study site; (49) ‘diagnostic specificity’ means the ability of a device to recognise the absence of a target marker associated with a particular disease or condition; (50) ‘diagnostic sensitivity’ means the ability of a device to identify the presence of a target marker associated with a particular disease or condition; (51) ‘predictive value’ means the probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition; (52) ‘positive predictive value’ means the ability of a device to separate true positive results from false positive results for a given attribute in a given population; (53) ‘negative predictive value’ means the ability of a device to separate true negative results from false negative results for a given attribute in a given population; (54) ‘likelihood ratio’ means the likelihood of a given result arising in an individual with the target clinical condition or physiological state compared to the likelihood of the same result arising in an individual without that clinical condition or physiological state; (55) ‘calibrator’ means a measurement reference material used in the calibration of a device; (56) ‘control material’ means a substance, material or article intended by its manufacturer to be used to verify the performance characteristics of a device; (57) ‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the performance study; (58) ‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular performance study, after having been informed of all aspects of the performance study that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the performance study; (59) ‘ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations; (60) ‘adverse event’ means any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a performance study, whether or not related to the device for performance study; (61) ‘serious adverse event’ means any adverse event that led to any of the following: (a) a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring, (b) death, (c) serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or prolongation of patient hospitalisation, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, (v) chronic disease, (d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect; (62) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance study, including malfunction, use errors or inadequacy in information supplied by the manufacturer; (63) ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions; (64) ‘market surveillance’ means the activities carried out and measures taken by public authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection; (65) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user; (66) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market; (67) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device; (68) ‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat; (69) ‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time; (70) ‘corrective action’ means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation; (71) ‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market; (72) ‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action; (73) ‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012; (74) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system. Section 2 Regulatory status of products and counselling Article 3 Regulatory status of products 1. Upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device Coordination Group established under Article 103 of Regulation (EU) 2017/745 (MDCG), by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘in vitro diagnostic medical device’ or ‘accessory for an in vitro diagnostic medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3) of this Regulation. 2. The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 3. The Commission shall ensure that Member States share expertise in the fields of in vitro diagnostic medical devices, medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products, in order to determine the appropriate regulatory status of a product, or category or group of products. 4. When deliberating on the possible regulatory status as a device of products involving medicinal products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency and the European Food Safety Authority, as relevant. Article 4 Genetic information, counselling and informed consent 1. Member States shall ensure that where a genetic test is used on individuals, in the context of healthcare as defined in point (a) of Article 3 of Directive 2011/24/EU of the European Parliament and of the Council (23) and for the medical purposes of diagnostics, improvement of treatment, predictive or prenatal testing, the individual being tested or, where applicable, his or her legally designated representative is provided with relevant information on the nature, the significance and the implications of the genetic test, as appropriate. 2. In the context of the obligations referred to in paragraph 1, Member States shall, in particular, ensure that there is appropriate access to counselling in the case of the use of genetic tests that provide information on the genetic predisposition for medical conditions and/or diseases which are generally considered to be untreatable according to the state of science and technology. 3. Paragraph 2 shall not apply in cases where a diagnosis of a medical condition and/or a disease which the individual being tested is already known to have is confirmed by a genetic test or in cases where a companion diagnostic is used. 4. Nothing in this Article shall prevent Member States from adopting or maintaining measures at national level which are more protective of patients, more specific or which deal with informed consent. CHAPTER II MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, CE MARKING, FREE MOVEMENT Article 5 Placing on the market and putting into service 1. A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose. 2. A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose. 3. Demonstration of conformity with the general safety and performance requirements shall include a performance evaluation in accordance with Article 56. 4. Devices that are manufactured and used within health institutions, with the exception of devices for performance studies, shall be considered as having been put into service. 5. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met: (a) the devices are not transferred to another legal entity; (b) manufacture and use of the devices occur under appropriate quality management systems; (c) the laboratory of the health institution is compliant with standard EN ISO 15189 or where applicable national provisions, including national provisions regarding accreditation; (d) the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market; (e) the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use; (f) the health institution draws up a declaration which it shall make publicly available, including: (i) the name and address of the manufacturing health institution, (ii) the details necessary to identify the devices, (iii) a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor; (g) as regards class D devices in accordance with the rules set out in Annex VIII, the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met. Member States may apply this provision also to class A, B or C devices in accordance with the rules set out in Annex VIII; (h) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (g); and (i) the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions. Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions. This paragraph shall not apply to devices that are manufactured on an industrial scale. 6. In order to ensure the uniform application of Annex I, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 6 Distance sales 1. A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation. 2. Without prejudice to national law regarding the exercise of the medical profession, a device that is not placed on the market but used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, or by other means of communication, directly or through intermediaries, to a natural or legal person established in the Union shall comply with this Regulation. 3. Upon request by a competent authority, any natural or legal person offering a device in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity of the device concerned. 4. A Member State may, on grounds of protection of public health, require a provider of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity. Article 7 Claims In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: (a) ascribing functions and properties to the device which the device does not have; (b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have; (c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; (d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out. Article 8 Use of harmonised standards 1. Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, performance studies, clinical evidence or post-market performance follow-up (‘PMPF’). References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union. 2. References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, provided that references to those monographs have been published in the Official Journal of the European Union. Article 9 Common specifications 1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the performance evaluation and PMPF set out in Annex XIII or the requirements regarding performance studies set out in Annex XIII. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 2. Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS. 3. Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto. Article 10 General obligations of manufacturers 1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation. 2. Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I. 3. Manufacturers shall conduct a performance evaluation in accordance with the requirements set out in Article 56 and Annex XIII, including a PMPF. 4. Manufacturers shall draw up and keep up to date the technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the light of technical progress, the Annexes II and III. 5. Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than devices for performance study, shall draw up an EU declaration of conformity in accordance with Article 17, and affix the CE marking of conformity in accordance with Article 18. 6. Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 24 and with the registration obligations referred to in Article 26 and 28. 7. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof. A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available. 8. Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in product design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a product is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than devices for performance study, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device. The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation. The quality management system shall address at least the following aspects: (a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system; (b) identification of applicable general safety and performance requirements and exploration of options to address those requirements; (c) responsibility of the management; (d) resource management, including selection and control of suppliers and sub-contractors; (e) risk management as set out in Section 3 of Annex I; (f) performance evaluation, in accordance with Article 56 and Annex XIII, including PMPF; (g) product realisation, including planning, design, development, production and service provision; (h) verification of the UDI assignments made in accordance with Article 24(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 26; (i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 78; (j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders; (k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance; (l) management of corrective and preventive actions and verification of their effectiveness; (m) processes for monitoring and measurement of output, data analysis and product improvement. 9. Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 78. 10. Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient. The information supplied in accordance with Section 20 of Annex I with devices for self-testing or near-patient testing shall be easily understandable and provided in the official Union language(s) determined by the Member State in which the device is made available to the user or patient. 11. Manufacturers that consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly. Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where applicable, the notified body that issued a certificate for the device in accordance with Article 51, in particular, of the non-compliance and of any corrective action taken. 12. Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 82 and 83. 13. Manufacturers shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned. The competent authority of the Member State in which the manufacturer has its registered place of business may require that the manufacturer provide samples of the device free of charge or, where that is impracticable, grant access to the device. Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market or put into service. If the manufacturer fails to cooperate or the information and documentation provided is incomplete or incorrect, the competent authority may, in order to ensure the protection of public health and patient safety, take all appropriate measures to prohibit or restrict the device's being made available on its national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete and correct information. If a competent authority considers or has reason to believe that a device has caused damage, it shall, upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's successor in title, the patient's or user's health insurance company or other third parties affected by the damage caused to the patient or user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights. The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal proceedings. 14. Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 27(1). 15. Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law. Article 11 Authorised representative 1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative. 2. The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group. 3. The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request. The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers: (a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer; (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51, at the disposal of competent authorities for the period referred to in Article 10(7); (c) comply with the registration obligations laid down in Article 28 and verify that the manufacturer has complied with the registration obligations laid down in Article 26; (d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned; (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device; (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices; (g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated; (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation. 4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11). 5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. 6. An authorised representative who terminates its mandate on the grounds referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor. 7. Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business. Article 12 Change of authorised representative The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the following aspects: (a) the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative; (b) the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material; (c) the transfer of documents, including confidentiality aspects and property rights; (d) the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative. Article 13 General obligations of importers 1. Importers shall place on the Union market only devices that are in conformity with this Regulation. 2. In order to place a device on the market, importers shall verify that: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up; (b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer; (c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use; (d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 24. Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established. 3. Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer. 4. Importers shall verify that the device is registered in the electronic system in accordance with Article 26. Importers shall add their details to the registration in accordance with Article 28. 5. Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available. 6. Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints. 7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative. Importers shall co-operate with the manufacturer, the manufacturer's authorised representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it, is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 51 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken. 8. Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative. 9. Importers shall, for the period referred to in Article 10(7), keep a copy of the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51. 10. Importers shall cooperate with competent authorities, at the latters' request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market. Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device. Article 14 General obligations of distributors 1. When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable. 2. Before making a device available on the market, distributors shall verify that all of the following requirements are met: (a) the device has been CE marked and the EU declaration of conformity of the device has been drawn up; (b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(10); (c) for imported devices, the importer has complied with the requirements set out in Article 13(3); (d) that, where applicable, a UDI has been assigned by the manufacturer. In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor. Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established. 3. Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer. 4. Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable the manufacturer's authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken. 5. Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request. 6. Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device. Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device. Article 15 Person responsible for regulatory compliance 1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices. The requisite expertise shall be demonstrated by either of the following qualifications: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices; (b) four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices. 2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (24) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal. 3. The person responsible for regulatory compliance shall at least be responsible for ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(9); (d) the reporting obligations referred to in Articles 82 to 86 are fulfilled; (e) in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued. 4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing. 5. The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation. 6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for in vitro diagnostic medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices; (b) four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices. Article 16 Cases in which obligations of manufacturers apply to importers, distributors or other persons 1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following: (a) makes available on the market a device under its own name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation; (b) changes the intended purpose of a device already placed on the market or put into service; (c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected. The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (23) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose. 2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements: (a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 20 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State; (b) changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging. 3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established. Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation. 4. At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities referred to in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or a mock-up of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3. Article 17 EU declaration of conformity 1. The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available. 2. Where, concerning aspects not covered by this Regulation, devices are subject to other Union legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the device. The declaration shall contain all the information required for identification of the Union legislation to which the declaration relates. 3. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device. 4. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress. Article 18 CE marking of conformity 1. Devices, other than devices for performance studies, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V. 2. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. 3. The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging. 4. The CE marking shall be affixed before the device is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use. 5. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 48. The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking. 6. Where devices are subject to other Union legislation which also provides for the affixing of the CE marking, the CE marking shall indicate that the devices also fulfil the requirements of that other legislation. Article 19 Devices for special purposes 1. Member States shall not create obstacles to devices for performance study being supplied for that purpose to laboratories or other institutions, if they meet the conditions laid down in Articles 57 to 76, and in the implementing acts adopted pursuant to Article 77. 2. The devices referred to in paragraph 1 shall not bear the CE marking, with the exception of the devices referred to in Article 70. 3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the showing of devices which do not comply with this Regulation, provided that a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation. Article 20 Parts and components 1. Any natural or legal person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence shall be kept available for the competent authorities of the Member States. 2. An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Regulation. Article 21 Free movement Except where otherwise provided for in this Regulation, Member States shall not refuse, prohibit or restrict the making available on the market or putting into service within their territory of devices which comply with the requirements of this Regulation. CHAPTER III IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES Article 22 Identification within the supply chain 1. Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices. 2. Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(7): (a) any economic operator to whom they have directly supplied a device; (b) any economic operator who has directly supplied them with a device; (c) any health institution or healthcare professional to which they have directly supplied a device. Article 23 Medical devices nomenclature To facilitate the functioning of the European database on medical devices (Eudamed) as referred to in Article 33 of Regulation (EU) 2017/745, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission shall also endeavour to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable. Article 24 Unique Device Identification system 1. The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than devices for performance studies, and shall consist of the following: (a) production of a UDI that comprises the following: (i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI; (ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI; (b) placing of the UDI on the label of the device or on its packaging; (c) storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 respectively; (d) establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with Article 28 of Regulation (EU) 2017/745. 2. The Commission shall, by means of implementing acts, designate one or several entities to operate a system for assignment of UDIs pursuant to this Regulation (‘issuing entity’). That entity or those entities shall satisfy all of the following criteria: (a) the entity is an organisation with legal personality; (b) its system for the assignment of UDIs is adequate to identify a device throughout its distribution and use in accordance with the requirements of this Regulation; (c) its system for the assignment of UDIs conforms to the relevant international standards; (d) the entity gives access to its system for the assignment of UDIs to all interested users in accordance with a set of predetermined and transparent terms and conditions; (e) the entity undertakes to do the following: (i) operate its system for the assignment of UDIs for at least 10 years after its designation; (ii) make available to the Commission and to the Member States, upon request, information concerning its system for the assignment of UDIs; (iii) remain in compliance with the criteria for designation and the terms of designation. When designating issuing entities, the Commission shall endeavour to ensure that UDI carriers, as defined in Part C of Annex VI, are universally readable regardless of the system used by the issuing entity, with a view to minimising financial and administrative burdens for economic operators, health institutions and healthcare professionals. 3. Before placing a device, other than a device for performance study, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2. Before a device, other than a device for performance study, is placed on the market the manufacturer must ensure that the information referred to in Part B of Annex V of the device in question are correctly submitted and transferred to the UDI database referred to in Article 25. 4. UDI carriers shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging shall not be understood to include shipping containers. 5. The UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 82. 6. The Basic UDI-DI, as defined in Part C of Annex VI of the device shall appear on the EU declaration of conformity referred to in Article 17. 7. As part of the technical documentation referred to in Annex II, the manufacturer shall keep up-to-date a list of all UDIs that it has assigned. 8. Economic operators shall store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 11. 9. Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied. Member States shall encourage, and may require, health care professionals to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied with. 10. The Commission is empowered to adopt delegated acts in accordance with Article 108: (a) amending the list of information set out in Part B of Annex VI in the light of technical progress; and (b) amending Annex VI in the light of international developments and technical progress in the field of Unique Device Identification. 11. The Commission may, by means of implementing acts, specify the detailed arrangements and the procedural aspects for the UDI system with a view to ensuring its harmonised application in relation to any of the following: (a) determining the devices, categories or groups of devices to which the obligation laid down in paragraph 8 is to apply; (b) specifying the data to be included in the UDI-PI of specific devices or device groups. The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 107(3). 12. When adopting the measures referred to in paragraph 11, the Commission shall take into account all of the following: (a) confidentiality and data protection as referred to in Articles 102 and 103 respectively; (b) the risk-based approach; (c) the cost-effectiveness of the measures; (d) the convergence of UDI systems developed at international level; (e) the need to avoid duplications in the UDI system; (f) the needs of the health care systems of the Member States, and where possible, compatibility with other medical device identification systems that are used by stakeholders. Article 25 UDI database The Commission, after consulting the MDCG, shall set up and manage a UDI database in accordance with the conditions and detailed arrangements provided for in Article 28 of Regulation (EU) 2017/745. Article 26 Registration of devices 1. Before placing a device on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 24(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device. 2. For devices that are the subject of a conformity assessment as referred to in Article 48(3) and (4), the second subparagraph of Article 48(7), Article 48(8) and the second subparagraph of Article 48(9), the assignment of a Basic UDI-DI referred to in paragraph 1 of this Article shall be done before the manufacturer applies to a notified body for that assessment. For the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI on the certificate issued in accordance with point (a) of Section 4 of Annex XII and confirm in Eudamed that the information referred to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device. 3. Before placing a device on the market, the manufacturer shall enter or, if already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2 thereof, and thereafter shall keep the information updated. Article 27 Electronic system for registration of economic operators 1. The Commission, after consulting the MDCG, shall set up and manage an electronic system to create the single registration number referred to in Article 28(2) and to collate and process information that is necessary and proportionate to identify the manufacturer and, where applicable, the authorised representative and the importer. The details regarding the information to be provided to that electronic system by the economic operators are laid down in Section 1 of Part A of Annex VI. 2. Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory. 3. Within two weeks of placing a device on the market, importers shall verify that the manufacturer or authorised representative has provided to the electronic system the information referred to in paragraph 1. Where applicable, importers shall inform the relevant authorised representative or manufacturer if the information referred to in paragraph 1 is not included or is incorrect. Importers shall add their details to the relevant entry/entries. Article 28 Registration of manufacturers, authorised representatives and importers 1. Before placing a device on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article. In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 48, the information referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the notified body. 2. After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 27 and issue it to the manufacturer, the authorised representative or the importer. 3. The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 26. 4. Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 27. 5. Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation. 6. Without prejudice to the economic operator's responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI. 7. The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 27 shall be accessible to the public. 8. The competent authority may use the data to charge the manufacturer, the authorised representative or the importer a fee pursuant to Article 104. Article 29 Summary of safety and performance 1. For class C and D devices, other than devices for performance studies, the manufacturer shall draw up a summary of safety and performance. The summary of safety and performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed. The draft of the summary of safety and performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 48 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available. 2. The summary of safety and performance shall include at least the following aspects: (a) the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN; (b) the intended purpose of the device and any indications, contra-indications and target populations; (c) a description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device; (d) reference to any harmonised standards and CS applied; (e) the summary of the performance evaluation as referred to in Annex XIII, and relevant information on the PMPF; (f) the metrological traceability of assigned values; (g) suggested profile and training for users; (h) information on any residual risks and any undesirable effects, warnings and precautions. 3. The Commission may, by means of implementing acts, set out the form and the presentation of the data elements to be included in the summary of safety and performance. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2). Article 30 European database on medical devices 1. The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) in accordance with the conditions and detailed arrangements established by Articles 33 and 34 of Regulation (EU) 2017/745. 2. Eudamed shall include the following electronic systems: (a) the electronic system for registration of devices referred to in Article 26; (b) the UDI database referred to in Article 25; (c) the electronic system on registration of economic operators referred to in Article 27; (d) the electronic system on notified bodies and on certificates referred to in Article 52; (e) the electronic system on performance studies referred to in Article 69, (f) the electronic system on vigilance and post-market surveillance referred to in Article 87; (g) the electronic system on market surveillance referred to in Article 95. CHAPTER IV NOTIFIED BODIES Article 31 Authorities responsible for notified bodies 1. Any Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out conformity assessment activities under this Regulation shall appoint an authority (the ‘authority responsible for notified bodies’), which may consist of separate constituent entities under national law and shall be responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, including subcontractors and subsidiaries of those bodies. 2. The authority responsible for notified bodies shall be established, organised and operated so as to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interests with conformity assessment bodies. 3. The authority responsible for notified bodies shall be organised in a manner such that each decision relating to designation or notification is taken by personnel different from those who carried out the assessment. 4. The authority responsible for notified bodies shall not perform any activities that notified bodies perform on a commercial or competitive basis. 5. The authority responsible for notified bodies shall safeguard the confidential aspects of the information it obtains. However, it shall exchange information on notified bodies with other Member States, the Commission and, when required, with other regulatory authorities. 6. The authority responsible for notified bodies shall have a sufficient number of competent personnel permanently available for the proper performance of its tasks. Where the authority responsible for notified bodies is a different authority from the national competent authority for in vitro diagnostic medical devices, it shall ensure that the national authority responsible for in vitro diagnostic medical devices is consulted on relevant matters. 7. Member States shall make publicly available general information on their measures governing the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and on changes which have a significant impact on such tasks. 8. The authority responsible for notified bodies shall participate in peer-review activities provided for in Article 44. Article 32 Requirements relating to notified bodies 1. Notified bodies shall fulfil the tasks for which they are designated in accordance with this Regulation. They shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil those tasks. In particular, notified bodies shall comply with Annex VII. In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent availability of sufficient administrative, technical and scientific personnel in accordance with Section 3.1.1 of Annex VII, and personnel with relevant clinical expertise in accordance with Section 3.2.4 of Annex VII, where possible employed by the notified body itself. The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified body itself and shall not be external experts or subcontractors. 2. Notified bodies shall make available and submit upon request all relevant documentation, including the manufacturer's documentation, to the authority responsible for notified bodies to allow it to conduct its assessment, designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined in this Chapter. 3. In order to ensure the uniform application of the requirements set out in Annex VII, the Commission may adopt implementing acts, to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 33 Subsidiaries and subcontracting 1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the authority responsible for notified bodies accordingly. 2. Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontractors or subsidiaries. 3. Notified bodies shall make publicly available a list of their subsidiaries. 4. Conformity assessment activities may be subcontracted or carried out by a subsidiary provided that the legal or natural person that applied for conformity assessment has been informed accordingly. 5. Notified bodies shall keep at the disposal of the authority responsible for notified bodies all relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation. Article 34 Application by conformity assessment bodies for designation 1. Conformity assessment bodies shall submit an application for designation to the authority responsible for notified bodies. 2. The application shall specify the conformity assessment activities as defined in this Regulation, and the types of devices for which the body is applying to be designated, and shall be supported by documentation demonstrating compliance with Annex VII. In respect of the organisational and general requirements and the quality management requirements set out in Sections 1 and 2 of Annex VII, a valid accreditation certificate and the corresponding evaluation report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008 may be submitted and shall be taken into consideration during the assessment described in Article 35. However, the applicant shall make available all the documentation referred to in the first subparagraph to demonstrate compliance with those requirements upon request. 3. The notified body shall update the documentation referred to in paragraph 2 whenever relevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements set out in Annex VII. Article 35 Assessment of the application 1. The authority responsible for notified bodies shall within 30 days check that the application referred to in Article 34 is complete and shall request the applicant to provide any missing information. Once the application is complete that national authority shall send it to the Commission. The authority responsible for notified bodies shall review the application and supporting documentation in accordance with its own procedures and shall draw up a preliminary assessment report. 2. The authority responsible for notified bodies shall submit the preliminary assessment report to the Commission which shall immediately transmit it to the MDCG. 3. Within 14 days of the submission referred to in paragraph 2 of this Article, the Commission, in conjunction with the MDCG, shall appoint a joint assessment team made up of three experts, unless the specific circumstances require a different number of experts, chosen from the list referred to in Article 36. One of the experts shall be a representative of the Commission who shall coordinate the activities of the joint assessment team. The other two experts shall come from Member States other than the one in which the applicant conformity assessment body is established. The joint assessment team shall be comprised of competent experts who are competent to assess the conformity assessment activities and the types of devices which are the subject of the application or, in particular when the assessment procedure is initiated in accordance with Article 43(3) to ensure that the specific concern can be appropriately assessed. 4. Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the application in accordance with Article 34. The joint assessment team may provide feedback to, or require clarification from, the authority responsible for notified bodies on the application and on the planned on-site assessment. The authority responsible for notified bodies together with the joint assessment team shall plan and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located inside or outside the Union, to be involved in the conformity assessment process. The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies. 5. Findings regarding non-compliance of an applicant conformity assessment body with the requirements set out in Annex VII shall be raised during the assessment process and discussed between the authority responsible for notified bodies and the joint assessment team with a view to reaching consensus and resolving any diverging opinions, with respect to the assessment of the application. At the end of the on-site assessment, the authority responsible for notified bodies shall list for the applicant conformity assessment body the non-compliances resulting from the assessment and summarise of the assessment by the joint assessment team. Within a specified timeframe, the applicant conformity assessment body shall submit to the national authority a corrective and preventive action plan to address the non-compliances. 6. The joint assessment team shall document any remaining diverging opinions with respect to the assessment within 30 days of completion of the on-site assessment and send them to the authority responsible for notified bodies. 7. The authority responsible for notified bodies shall, following receipt of a corrective and preventive action plan from the applicant body, assess whether non-compliances identified during the assessment have been appropriately addressed. This plan shall indicate the root cause of the identified non-compliances and shall include a timeframe for implementation of the actions therein. The authority responsible for notified bodies shall, having confirmed the corrective and preventive action plan, forward it and its opinion thereon to the joint assessment team. The joint assessment team may request of the authority responsible for notified bodies further clarification and modifications. The authority responsible for notified bodies shall draw up its final assessment report which shall include: — the result of the assessment, — confirmation that the corrective and preventive actions have been appropriately addressed and, where required, implemented, — any remaining diverging opinion with the joint assessment team, and, where applicable, — the recommended scope of designation. 8. The authority responsible for notified bodies shall submit its final assessment report and, if applicable, the draft designation to the Commission, the MDCG and the joint assessment team. 9. The joint assessment team shall provide a final opinion regarding the assessment report prepared by the authority responsible for notified bodies and, if applicable, the draft designation within 21 days of receipt of those documents to the Commission which shall immediately submit that final opinion to the MDCG. Within 42 days of receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft designation, which the authority responsible for notified bodies shall duly take into consideration for its decision on the designation of the notified body. 10. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements specifying procedures and reports for the application for designation referred to in Article 34 and the assessment of the application set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 36 Nomination of experts for joint assessment of applications for notification 1. The Member States and the Commission shall nominate experts qualified in the assessment of conformity assessment bodies in the field of in vitro diagnostic medical devices to participate in the activities referred to in Articles 35 and 44. 2. The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article, together with information on their specific field of competence and expertise. That list shall be made available to Member States competent authorities through the electronic system referred to in Article 52. Article 37 Language requirements All documents required pursuant to Articles 34 and 35 shall be drawn up in a language or languages which shall be determined by the Member State concerned. Member States, in applying the first paragraph, shall consider accepting and using a commonly understood language in the medical field, for all or part of the documentation concerned. The Commission shall provide translations of the documentation pursuant to Articles 34 and 35, or parts thereof into an official Union language, such as is necessary for that documentation to be readily understood by the joint assessment team appointed in accordance with Article 35(3). Article 38 Designation and notification procedure 1. Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 35 was completed and which comply with Annex VII. 2. Member States shall notify the Commission and the other Member States of the conformity assessment bodies they have designated, using the electronic notification tool within the database of notified bodies developed and managed by the Commission (NANDO). 3. The notification shall clearly specify, using the codes referred to in paragraph 13 of this Article, the scope of the designation indicating the conformity assessment activities as defined in this Regulation, and the types of devices which the notified body is authorised to assess and, without prejudice to Article 40, any conditions associated with the designation. 4. The notification shall be accompanied by the final assessment report of the authority responsible for notified bodies, the final opinion of the joint assessment team referred to in Article 35(9) and the recommendation of the MDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it shall provide a duly substantiated justification. 5. The notifying Member State shall, without prejudice to Article 40, inform the Commission and the other Member States of any conditions associated with the designation and provide documentary evidence regarding the arrangements in place to ensure that the notified body will be monitored regularly and will continue to satisfy the requirements set out in Annex VII. 6. Within 28 days of the notification referred to in paragraph 2, a Member State or the Commission may raise written objections, setting out its arguments, with regard either to the notified body or to its monitoring by the authority responsible for notified bodies. Where no objection is raised, the Commission shall publish in NANDO the notification within 42 days of its having been notified as referred to in paragraph 2. 7. When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall bring the matter before the MDCG within 10 days of the expiry of the period referred to in paragraph 6. After consulting the parties involved, the MDCG shall give its opinion at the latest within 40 days of the matter having been brought before it. Where the MDCG is of the opinion that the notification can be accepted, the Commission shall publish in NANDO the notification within 14 days. 8. Where the MDCG, after having been consulted in accordance with paragraph 7, confirms the existing objection or raises another objection, the notifying Member State shall provide a written response to the MDCG opinion within 40 days of its receipt. The response shall address the objections raised in the opinion, and set out the reasons for the notifying Member State's decision to designate or not designate the conformity assessment body. 9. Where the notifying Member State decides to uphold its decision to designate the conformity assessment body, having given its reasons in accordance with paragraph 8, the Commission shall publish in NANDO the notification within 14 days of being informed thereof. 10. When publishing the notification in NANDO, the Commission shall add to the electronic system referred to in Article 52 the information relating to the notification of the notified body along with the documents mentioned in paragraph 4 of this Article and the opinion and response referred to in paragraphs 7 and 8 of this Article. 11. The designation shall become valid the day after the notification is published in NANDO. The published notification shall state the scope of lawful conformity assessment activity of the notified body. 12. The conformity assessment body concerned may perform the activities of a notified body only after the designation has become valid in accordance with paragraph 11. 13 The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of codes and corresponding types of devices for the purpose of specifying the scope of the designation of notified bodies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). The Commission, after consulting the MDCG, may update this list based, inter alia, on information arising from the coordination activities described in Article 44. Article 39 Identification number and list of notified bodies 1. The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 38(11). It shall assign a single identification number even when the body is notified under several Union acts. If they are successfully designated in accordance with this Regulation, bodies notified pursuant to Directive 98/79/EC shall retain the identification number assigned to them pursuant to that Directive. 2. The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities as defined in this Regulation and the types of devices for which they have been notified, accessible to the public in NANDO. It shall also make this list available on the electronic system referred to in Article 52. The Commission shall ensure that the list is kept up to date. Article 40 Monitoring and re-assessment of notified bodies 1. Notified bodies shall, without delay, and at the latest within 15 days, inform the authority responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out in Annex VII or their ability to conduct the conformity assessment activities relating to the devices for which they have been designated. 2. The authorities responsible for notified bodies shall monitor the notified bodies established on their territory and their subsidiaries and subcontractors to ensure ongoing compliance with the requirements and the fulfilment of its obligations set out in this Regulation. Notified bodies shall, upon request by their authority responsible for notified bodies, supply all relevant information and documents, required to enable the authority, the Commission and other Member States to verify compliance. 3. Where the Commission or the authority of a Member State submits a request to a notified body established on the territory of another Member State relating to a conformity assessment carried out by that notified body, it shall send a copy of that request to the authority responsible for notified bodies of that other Member State. The notified body concerned shall respond without delay and within 15 days at the latest to the request. The authority responsible for notified bodies of the Member State in which the body is established shall ensure that requests submitted by authorities of any other Member State or by the Commission are resolved by the notified body unless there is a legitimate reason for not doing so in which case the matter may be referred to the MDCG. 4. At least once a year, the authorities responsible for notified bodies shall re-assess whether the notified bodies established on their respective territory and, where appropriate, the subsidiaries and subcontractors under the responsibility of those notified bodies still satisfy the requirements and fulfil their obligations set out in Annex VII. That review shall include an on-site audit of each notified body and, where necessary, of its subsidiaries and subcontractors. The authority responsible for notified bodies shall conduct its monitoring and assessment activities according to an annual assessment plan to ensure that it can effectively monitor the continued compliance of the notified body with the requirements of this Regulation. That plan shall provide a reasoned schedule for the frequency of assessment of the notified body and, in particular, associated subsidiaries and subcontractors. The authority shall submit its annual plan for monitoring or assessment for each notified body for which it is responsible to the MDCG and to the Commission. 5. The monitoring of notified bodies by the authority responsible for notified bodies shall include observed audits of notified body personnel, including where necessary any personnel from subsidiaries and subcontractors, as that personnel in the process of conducting quality management system assessments at a manufacturer's facility. 6. The monitoring of notified bodies conducted by the authority responsible for notified bodies shall consider data arising from market surveillance, vigilance and post-market surveillance to help guide its activities. The authority responsible for notified bodies shall provide for a systematic follow-up of complaints and other information, including from other Member States, which may indicate non-fulfilment of the obligations by a notified body or its deviation from common or best practice. 7. The authority responsible for notified bodies may in addition to regular monitoring or on-site assessments conduct short-notice, unannounced or ‘for-cause’ reviews if needed to address a particular issue or to verify compliance. 8. The authority responsible for notified bodies shall review the assessments by notified bodies of manufacturers' technical documentation, in particular the performance evaluation documentation as further outlined in Article 41. 9. The authority responsible for notified bodies shall document and record any findings regarding non-compliance of the notified body with the requirements set out in Annex VII and shall monitor the timely implementation of corrective and preventive actions. 10. Three years after notification of a notified body, and again every fourth year thereafter, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII shall be conducted by the authority responsible for notified bodies of the Member State in which the body is established and by a joint assessment team appointed for the purpose of the procedure described in Articles 34 and 35. 11. The Commission is empowered to adopt delegated acts in accordance with Article 108 in order to amend paragraph 10 of this Article to modify the frequency at which the complete re-assessment referred to in that paragraph is to be carried out. 12. The Member States shall report to the Commission and to the MDCG, at least once a year, on their monitoring and on-site assessment activities regarding notified bodies and, where applicable, subsidiaries and subcontractors. The report shall provide details of the outcome of those activities, including activities pursuant to paragraph 7, and shall be treated as confidential by the MDCG and the Commission; however, it shall contain a summary which shall be made publicly available. The summary of the report shall be uploaded to the electronic system referred to in Article 52. Article 41 Review of notified body assessment of technical documentation and performance evaluation documentation 1. The authority responsible for notified bodies, as part of its ongoing monitoring of notified bodies, shall review an appropriate number of notified body assessments of manufacturers' technical documentation, in particular the performance evaluation documentation to verify the conclusions drawn by the notified body based on the information presented by the manufacturer. The reviews by the authority responsible for notified bodies shall be conducted both off-site and on-site. 2. The sampling of files to be reviewed in accordance with paragraph 1 shall be planned and representative of the types and risk of devices certified by the notified body, in particular high-risk devices, and be appropriately justified and documented in a sampling plan, which shall be made available by the authority responsible for notified bodies to the MDCG upon request. 3. The authority responsible for notified bodies shall review whether the assessment by the notified body was conducted appropriately and shall check the procedures used, associated documentation and the conclusions drawn by the notified body. Such checking shall include the technical documentation and performance evaluation documentation of the manufacturer upon which the notified body has based its assessment. Such reviews shall be conducted utilising CS. 4. Those reviews shall also form part of the re-assessment of notified bodies in accordance with Article 40(10) and the joint assessment activities referred to in Article 43(3). The reviews shall be conducted utilising appropriate expertise. 5. Based on the reports of the reviews and assessments by the authority responsible for notified bodies or joint assessment teams, on input from the market surveillance, vigilance and post-market surveillance activities described in Chapter VII, or on the continuous monitoring of technical progress, or on the identification of concerns and emerging issues concerning the safety and performance of devices, the MDCG may recommend that the sampling carried out under this Article cover a greater or lesser proportion of the technical documentation and performance evaluation documentation assessed by a notified body. 6. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements, associated documents for, and coordination of, the review of assessments of technical documentation and performance evaluation documentation, as referred to in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 42 Changes to designations and notifications 1. The authority responsible for notified bodies shall notify the Commission and the other Member States of any relevant changes to the designation of a notified body. The procedures described in Article 35 and in Article 38 shall apply to extensions of the scope of the designation. For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs shall apply. 2. The Commission shall immediately publish the amended notification in NANDO. The Commission shall immediately enter information on the changes to the designation of the notified body in the electronic system referred to in Article 52. 3. Where a notified body decides to cease its conformity assessment activities it shall inform the authority responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine months after cessation of the notified body's activities on condition that another notified body has confirmed in writing that it will assume responsibilities for the devices covered by those certificates. The new notified body shall complete a full assessment of the devices affected by the end of that period before issuing new certificates for those devices. Where the notified body has ceased its activity, the authority responsible for notified bodies shall withdraw the designation. 4. Where a authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or partially withdraw the designation, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same period. The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of any suspension, restriction or withdrawal of a designation. 5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days. 6. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them available to authorities in other Member States responsible for notified bodies and to authorities responsible for market surveillance at their request. 7 In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall: (a) assess the impact on the certificates issued by the notified body; (b) submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation; (c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued to ensure the safety of devices on the market; (d) enter in the electronic system referred to in Article 52 information in relation to certificates of which it has required their suspension or withdrawal; (e) inform the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer has its registered place of business through the electronic system referred to in Article 52 of the certificates for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or others. 8. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in the following circumstances: (a) the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction and the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy the suspension or restriction; or (b) the authority responsible for notified bodies has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor, and remain responsible for, existing certificates issued for the period of the suspension or restriction. In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the manufacturer shall provide, to the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction. 9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances: (a) where the competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and (b) another notified body has confirmed in writing that it will assume immediate responsibilities for those devices and will have completed assessment of them within twelve months of the withdrawal of the designation. In the circumstances referred to in the first subparagraph, the national competent authority for in vitro diagnostic medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months. The authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof. Article 43 Challenge to the competence of notified bodies 1. The Commission, in conjunction with the MDCG, shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body, or of one or more of its subsidiaries or subcontractors, of the requirements set out in Annex VII or the obligations to which they are subject. It shall ensure that the relevant authority responsible for notified bodies is informed and is given an opportunity to investigate those concerns. 2. The notifying Member State shall provide the Commission, on request, with all information regarding the designation of the notified body concerned. 3. The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment procedure described in Article 35(3) and (5) where there is reasonable concern about the ongoing compliance of a notified body or a subsidiary or subcontractor of the notified body with the requirements set out in Annex VII and where the investigation by the authority responsible for notified bodies is not deemed to have fully addressed the concerns or upon request of the authority responsible for notified bodies. The reporting and outcome of that assessment shall follow the principles of Article 35. Alternatively, depending on the severity of the issue, the Commission, in conjunction with the MDCG, may request that the authority responsible for notified bodies allow the participation of up to two experts from the list established pursuant to Article 36 in an on-site assessment as part of the planned monitoring and assessment activities in accordance with Article 40 and as outlined in the annual assessment plan described in Article 40(4) therein. 4. Where the Commission ascertains that a notified body no longer meets the requirements for its designation, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the designation if necessary. Where the Member State fails to take the necessary corrective measures, the Commission may, by means of implementing acts, suspend, restrict or withdraw the designation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). It shall notify the Member State concerned of its decision and update NANDO and the electronic system referred to in Article 52. 5. The Commission shall ensure that all confidential information obtained in the course of its investigations is treated accordingly. Article 44 Peer review and exchange of experience between authorities responsible for notified bodies 1. The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the authorities responsible for notified bodies. Such exchange shall cover elements including: (a) development of best practice documents relating to the activities of the authorities responsible for notified bodies; (b) development of guidance documents for notified bodies in relation to the implementation of this Regulation; (c) training and qualification of the experts referred to in Article 36; (d) monitoring of trends relating to changes to notified body designations and notifications, and trends in certificate withdrawals and transfers between notified bodies; (e) monitoring of the application and applicability of scope codes referred to in Article 38(13); (f) development of a mechanism for peer reviews between authorities and the Commission; (g) methods of communication to the public on the monitoring and surveillance activities of authorities and the Commission on notified bodies. 2. The authorities responsible for notified bodies shall participate in a peer review every third year through the mechanism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be conducted in parallel with the on-site joint assessments described in Article 35. Alternatively, a national authority may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 40. 3. The Commission shall participate in the organisation and provide support to the implementation of the peer review mechanism. 4. The Commission shall compile an annual summary report of the peer review activities, which shall be made publicly available. 5. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements and related documents for the peer review mechanisms and training and qualification as referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 45 Coordination of notified bodies The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of the coordination group of notified bodies, as referred to in Article 49 of Regulation (EU) 2017/745. The bodies notified under this Regulation shall participate in the work of that group. Article 46 List of standard fees Notified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available. CHAPTER V CLASSIFICATION AND CONFORMITY ASSESSMENT Section 1 Classification Article 47 Classification of devices 1. Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII. 2. Any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State in which the authorised representative referred to in the last indent of point (b) of the second paragraph of Section 2.2. of Annex IX has its registered place of business. Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after consultation with the competent authority of the Member State that designated the notified body. The competent authority of the Member State in which the manufacturer has its registered place of business shall notify the MDCG and the Commission of its decision. The decision shall be made available upon request. 3. At the request of a Member State, the Commission shall after consulting the MDCG, decide, by means of implementing acts, on the following: (a) application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices; (b) that a device, or category or group of devices, shall for reasons of public health based on new scientific evidence, or based on any information which becomes available in the course of the vigilance and market surveillance activities be reclassified, by way of derogation from Annex VIII. 4. The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in points (a) and (b) of paragraph 3. 5. In order to ensure the uniform application of Annex VIII, and taking account of the relevant scientific opinions of the relevant scientific committees, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. 6. The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted in accordance with the examination procedure referred to in Article 107(3). Section 2 Conformity assessment Article 48 Conformity assessment procedures 1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI. 2. Prior to putting into service a device that is not placed on the market, with the exception of in-house devices manufactured pursuant to Article 5(5), manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI. 3. Manufacturers of class D devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I, II except for Section 5, and in Chapter III of Annex IX. In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX. In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics, the notified body shall consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council (25) or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX. 4. Manufacturers of class D devices, other than devices for performance study, may, instead of the conformity assessment procedure applicable pursuant to paragraph 3, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI. For companion diagnostics, the notified body shall in particular consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X. 5. In particular, and without prejudice to any of the obligations pursuant to the other procedures referred to in paragraphs 3 and 4, for devices for which one or more EU reference laboratories have been designated in accordance with Article 100, the notified body performing the conformity assessment shall request one of the EU reference laboratories to verify by laboratory testing the performance claimed by the manufacturer and the compliance of the device with the applicable CS, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in Section 4.9 of Annex IX and in point (j) of Section 3 of Annex X. Laboratory tests performed by an EU reference laboratory shall in particular focus on analytical and diagnostic sensitivity using the best available reference materials. 6. In addition to the procedure applicable pursuant to paragraphs 3 and 4, where no CS are available for class D devices and where it is also the first certification for that type of device, the notified body shall consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 on the performance evaluation report of the manufacturer. To that end, the notified body shall provide the performance evaluation report of the manufacturer to the expert panel within five days of receiving it from the manufacturer. The relevant experts shall, under the supervision of the Commission, provide their views, in accordance with Section 4.9 of Annex IX or point (j) of Section 3 of Annex X, as applicable, to the notified body within the deadline for delivery of the scientific opinion by the EU reference laboratory as specified therein. 7. Manufacturers of class C devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including an assessment of the technical documentation as specified in Sections 4.4 to 4.8 of that Annex of at least one representative device per generic device group. In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX. In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics the notified body shall for every device follow the procedure for technical documentation assessment laid down in Section 5.2 of Annex IX, and shall apply the procedure for technical documentation assessment laid down in Sections 4.1 to 4.8 of Annex IX and shall consult the competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX. 8. Manufacturers of class C devices, other than devices for performance study, may, instead of the conformity assessment procedure pursuant to paragraph 7, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI except its Section 5. For companion diagnostics the notified body shall in particular for every device consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X. 9. Manufacturers of class B devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Sections 4.4 to 4.8 of that Annex for at least one representative device per category of devices. In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for assessment of the technical documentation set out in Section 5.1 of Annex IX. 10. Manufacturers of class A devices, other than devices for performance study, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17, after drawing up the technical documentation set out in Annexes II and III. However, if those devices are placed on the market in sterile condition, the manufacturer shall apply the procedures set out in Annex IX or in Annex XI. Involvement of the notified body shall be limited to the aspects relating to establishing, securing and maintaining sterile conditions. 11. Devices for performance studies shall be subject to the requirements set out in Articles 57 to 77. 12. The Member State in which the notified body is established may require that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the procedures referred to in paragraphs 1 to 10 be made available in an official Union language(s) determined by that Member State. In the absence of such requirement, those documents shall be available in any official Union language acceptable to the notified body. 13. The Commission may, by means of implementing acts, specify the detailed arrangements and procedural aspects with a view to ensuring the harmonised application of the conformity assessment procedures by the notified bodies, for any of the following aspects: (a) the frequency and the sampling basis of the assessment of the technical documentation on a representative basis as set out in third paragraph of Section 2.3. and in Section 3.5 of Annex IX, in the case of class C devices; (b) the minimum frequency of unannounced on-site audits and sample tests to be conducted by notified bodies in accordance with Section 3.4 of Annex IX, taking into account the risk-class and the type of device; (c) the frequency of samples of the manufactured devices or batches of class D devices to be sent to an EU reference laboratory designated under Article 100 in accordance with Section 4.12 of Annex IX and Section 5.1 of Annex XI; or (d) the physical, laboratory or other tests to be carried out by notified bodies in the context of sample tests, assessment of technical documentation and type examination in accordance with Sections 3.4 and 4.3 of Annex IX and points (f) and (g) of Section 3. of Annex X. The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 49 Involvement of notified bodies in conformity assessment procedures 1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for conformity assessment activities related to the types of devices concerned. The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure. 2. The notified body concerned shall, by means of the electronic system referred to in Article 52, inform the other notified bodies of any manufacturer that withdraws its application prior to the notified body's decision regarding the conformity assessment. 3. When applying to a notified body under paragraph 1, manufacturers shall declare whether they have withdrawn an application with another notified body prior to the decision of that notified body and provide information about any previous application for the same conformity assessment that has been refused by another notified body. 4. The notified body may require any information or data from the manufacturer, which is necessary in order to properly conduct the chosen conformity assessment procedure. 5. Notified bodies and the personnel of notified bodies shall carry out their conformity assessment activities with the highest degree of professional integrity and the requisite technical and scientific competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups with an interest in the results of those activities. Article 50 Mechanism for scrutiny of conformity assessments of class D devices 1. A notified body shall notify the competent authority of certificates it has granted for class D devices, with the exception of applications to supplement or renew existing certificates. Such notification shall take place through the electronic system referred to in Article 52 and shall include the instructions for use referred to in Section 20.4 of Annex I, the summary of safety and performance referred to in Article 29, the assessment report by the notified body, and, where applicable, the laboratory tests and the scientific opinion by the EU reference laboratory pursuant to the second subparagraph of Article 48(3), and where applicable the views expressed in accordance with Article 48(4) by the experts referred to in Article 106 of Regulation (EU) 2017/745. In the case of divergent views between the notified body and the experts, a full justification shall also be included. 2. A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further procedures in accordance with Article 40, 41, 42, 43 or 89 and, where deemed necessary, take appropriate measures in accordance with to Articles 90 and 92. 3. The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice from the expert panels in relation to the safety and performance of any device. Article 51 Certificates of conformity 1. The certificates issued by the notified bodies in accordance with Annexes IX, X and XI shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body. The minimum content of the certificates shall be as set out in Annex XII. 2. The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid as long as the certificate which it supplements is valid. 3. Notified bodies may impose restrictions to the intended purpose of a device to certain groups of patients or users or require manufacturers to undertake specific PMPF studies pursuant to Part B of Annex XIII. 4. Where a notified body finds that the requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision. 5. The notified body shall enter in the electronic system referred to in Article 52 any information regarding certificates issued, including amendments and supplements thereto, and regarding suspended, reinstated, withdrawn or refused certificates and restrictions imposed on certificates. Such information shall be accessible to the public. 6. In the light of technical progress, the Commission is empowered to adopt delegated acts in accordance with Article 108 amending the minimum content of the certificates set out in Annex XII. Article 52 Electronic system on notified bodies and on certificates of conformity For the purposes of this Regulation, the following information shall be collated and processed pursuant to Article 57 of Regulation (EU) 2017/745 in the electronic system set up in accordance with that Article: (a) the list of subsidiaries referred to in Article 33(2); (b) the list of experts referred to in Article 36(2); (c) the information relating to the notification referred to in Article 38(10) and the amended notifications referred to in Article 42(2); (d) the list of notified bodies referred to in Article 39(2); (e) the summary of the report referred to in Article 40(12); (f) the notifications for conformity assessments and certificates referred to in Article 50(1); (g) withdrawal or refusals of applications for the certificates as referred to in Article 49(2) and Section 4.3 of Annex VII; (h) the information regarding certificates referred to in Article 51(5); (i) the summary of safety and performance referred to in Article 29. Article 53 Voluntary change of notified body 1. In cases where a manufacturer terminates its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects: (a) the date on which the certificates issued by the outgoing notified body become invalid; (b) the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material; (c) the transfer of documents, including confidentiality aspects and property rights; (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to the incoming notified body; (e) the last serial number or lot number for which the outgoing notified body is responsible. 2. The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date on which they become invalid. Article 54 Derogation from the conformity assessment procedures 1. By way of derogation from Article 48, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service, within the territory of the Member State concerned, of a specific device for which the procedures referred to in that Article have not been carried out but use of which is in the interest of public health or patient safety or health. 2. The Member State shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient. 3. Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the Union and set the conditions under which the device may be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 107(4). Article 55 Certificate of free sale 1. For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State in which the manufacturer or the authorised representative has its registered place of business shall issue a certificate of free sale declaring that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE-marking in accordance with this Regulation may be marketed in the Union. The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 26. Where a notified body has issued a certificate pursuant to Article 51, the certificate of free sale shall set out the unique number identifying the certificate issued by the notified body, as referred to in Section 3 of Chapter II of Annex XII. 2. The Commission may, by means of implementing acts, establish a model for certificates of free sale, taking into account international practice as regards the use of certificates of free sale. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2). CHAPTER VI CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES Article 56 Performance evaluation and clinical evidence 1. Confirmation of conformity with relevant general safety and performance requirements set out in Annex I, in particular those concerning the performance characteristics referred to in Chapter I and Section 9 of Annex I, under the normal conditions of the intended use of the device, and the evaluation of the interference(s) and cross-reaction(s) and of the acceptability of the benefit-risk ratio referred to in Sections 1 and 8 of Annex I, shall be based on scientific validity, analytical and clinical performance data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III. The manufacturer shall specify and justify the level of the clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose. To that end, manufacturers shall plan, conduct and document a performance evaluation in accordance with this Article and with Part A of Annex XIII. 2. The clinical evidence shall support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan. 3. A performance evaluation shall follow a defined and methodologically sound procedure for the demonstration of the following, in accordance with this Article and with Part A of Annex XIII: (a) scientific validity; (b) analytical performance; (c) clinical performance. The data and conclusions drawn from the assessment of those elements shall constitute the clinical evidence for the device. The clinical evidence shall be such as to scientifically demonstrate, by reference to the state of the art in medicine, that the intended clinical benefit(s) will be achieved and that the device is safe. The clinical evidence derived from the performance evaluation shall provide scientifically valid assurance, that the relevant general safety and performance requirements set out in Annex I, are fulfilled, under normal conditions of use. 4. Clinical performance studies in accordance with Section 2 of Part A of Annex XIII shall be carried out unless it is duly justified to rely on other sources of clinical performance data. 5. The scientific validity data, the analytical performance data and the clinical performance data, their assessment and the clinical evidence derived therefrom, shall be documented in the performance evaluation report referred to in Section 1.3.2 of Part A of Annex XIII. The performance evaluation report shall be part of the technical documentation, referred to in Annex II, relating to the device concerned. 6. The performance evaluation and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from implementation of the manufacturer's PMPF plan in accordance with Part B of Annex XIII and the post-market surveillance plan referred to in Article 79. The performance evaluation report for class C and D devices shall be updated when necessary, but at least annually, with the data referred to in the first subparagraph. The summary of safety and performance referred to in Article 29(1) shall be updated as soon as possible, where necessary. 7. Where necessary to ensure the uniform application of Annex XIII, the Commission may, having due regard to technical and scientific progress, adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 57 General requirements regarding performance studies 1. The manufacturer shall ensure that a device for performance study complies with the general safety and performance requirements set out in Annex I apart from the aspects covered by the performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient, user and other persons. 2. Where appropriate, performance studies shall be performed in circumstances similar to the normal conditions of use of the device. 3. Performance studies shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in such performance studies are protected and prevail over all other interests and the data generated are scientifically valid, reliable and robust. Performance studies, including performance studies that use left-over samples, shall be conducted in accordance with applicable law on data protection. Article 58 Additional requirements for certain performance studies 1. Any performance study: (a) in which surgically invasive sample-taking is done only for the purpose of the performance study; (b) that is an interventional clinical performance study as defined in point (46) of Article 2; or (c) where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies, shall, in addition to meeting the requirements set out in Article 57 and Annex XIII, be designed, authorised, conducted, recorded and reported in accordance with this Article and Articles 59 to 77 and Annex XIV. 2. Performance studies involving companion diagnostics shall be subject to the same requirements as the performance studies listed in paragraph 1. This does not apply to performance studies involving companion diagnostics using only left-over samples. Such studies shall however be notified to the competent authority. 3. Performance studies shall be subject to scientific and ethical review. The ethical review shall be performed by an ethics committee in accordance with national law. Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a performance study. At least one lay person shall participate in the ethical review. 4. Where the sponsor of a performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor. Member States may choose not to apply the first subparagraph to performance studies to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that performance study who shall be the addressee for all communications with the sponsor provided for in this Regulation. 5. A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions are met: (a) the performance study is the subject of an authorisation by the Member State(s) in which the performance study is to be conducted, in accordance with this Regulation, unless otherwise stated; (b) an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the performance study, which is valid for that entire Member State under its national law; (c) the sponsor or its legal representative or a contact person pursuant to paragraph 4 is established in the Union; (d) vulnerable populations and subjects are appropriately protected in accordance with Articles 59 to 64; (e) the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored; (f) the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent, in accordance with Article 59; (g) the subject or, where the subject is not able to give informed consent, his or her legally designated representative, has been provided with the contact details of an entity where further information can be received in case of need; (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with Directive 95/46/EC are safeguarded; (i) the performance study has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the performance study plan and constantly monitored; (j) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, any other person entitled by national law to provide the relevant patient care under performance study conditions; (k) no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his or her legally designated representatives, to participate in the performance study; (l) where appropriate, biological safety testing reflecting the latest scientific knowledge or any other test deemed necessary in the light of the device's intended purpose has been conducted; (m) in the case of clinical performance studies, the analytical performance has been demonstrated, taking into consideration the state of the art; (n) in the case of interventional clinical performance studies, the analytical performance and scientific validity has been demonstrated, taking into consideration the state of the art. Where, for companion diagnostics, the scientific validity is not established, the scientific rationale for the use of the biomarker shall be provided; (o) the technical safety of the device with regard to its use has been proven, taking into consideration the state of the art as well as provisions in the field of occupational safety and accident prevention; (p) the requirements of Annex XIV are fulfilled. 6. Any subject, or, where the subject is not able to give informed consent, his or her legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the performance study at any time by revoking his or her informed consent. Without prejudice to Directive 95/46/EC, the withdrawal of the informed consent shall not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal. 7. The investigator shall be a person exercising a profession which is recognised in the Member State concerned, as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care or laboratory medicine. Other personnel involved in conducting a performance study shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks. 8. Where appropriate, the facilities where the performance study involving subjects is to be conducted shall be suitable for the performance study and shall be similar to the facilities where the device is intended to be used. Article 59 Informed consent 1. Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subject or, where the subject is not able to give informed consent, his or her legally designated representative after having been duly informed in accordance with paragraph 2. Where the subject is unable to write, consent may be given and recorded through appropriate alternative means in the presence of at least one impartial witness. In that case, the witness shall sign and date the informed consent document. The subject or, where the subject is not able to give informed consent, his or her legally designated representative shall be provided with a copy of the document or the record, as appropriate, by which informed consent has been given. The informed consent shall be documented. Adequate time shall be given for the subject or his or her legally designated representative to consider his or her decision to participate in the performance study. 2. Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent shall: (a) enable the subject or his or her legally designated representative to understand: (i) the nature, objectives, benefits, implications, risks and inconveniences of the performance study; (ii) the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the performance study at any time without any resulting detriment and without having to provide any justification; (iii) the conditions under which the performance study is to be conducted, including the expected duration of the subject's participation in the performance study; and (iv) the possible treatment alternatives, including the follow-up measures if the participation of the subject in the performance study is discontinued; (b) be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her legally designated representative; (c) be provided in a prior interview with a member of the investigating team who is appropriately qualified under national law; and (d) include information about the applicable damage compensation system referred to in Article 65; (e) include the Union-wide unique single identification number for the performance study referred to in Article 66(1) and information about the availability of the performance study results in accordance with paragraph 6 of this Article. 3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative. 4. In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information. 5. In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information. 6. The subject shall be informed that a report of the performance study and a summary presented in terms understandable to the intended user will be made available pursuant to Article 73(5) in the electronic system on performance studies referred to in Article 69, irrespective of the outcome of the performance study, and shall be informed, to the extent possible, when they have become available. 7. This Regulation is without prejudice to national law requiring that, in addition to the informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to him or her, shall also assent in order to participate in a performance study. Article 60 Performance studies on incapacitated subjects 1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a performance study may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met: (a) the informed consent of their legally designated representative has been obtained; (b) the incapacitated subjects have received the information referred to in Article 59(2) in a way that is adequate in view of their capacity to understand it; (c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator; (d) no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the performance study; (e) the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in performance studies on persons able to give informed consent, or by other research methods; (f) the performance study relates directly to a medical condition from which the subject suffers; (g) there are scientific grounds for expecting that participation in the performance study will produce: (i) a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or (ii) some benefit for the population represented by the incapacitated subject concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned in comparison with the standard treatment of the incapacitated subject's condition. 2. The subject shall as far as possible take part in the informed consent procedure. 3. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens involved. Article 61 Performance studies on minors 1. A performance study on minors may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met: (a) the informed consent of their legally designated representative has been obtained; (b) the minors have received the information referred to in Article 59(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children; (c) the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator; (d) no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the performance study; (e) the performance study is intended to investigate treatments for a medical condition that only occurs in minors or the performance study is essential with respect to minors to validate data obtained in performance studies on persons able to give informed consent or by other research methods; (f) the performance study either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors; (g) there are scientific grounds for expecting that participation in the performance study will produce: (i) a direct benefit to the minor subject outweighing the risks and burdens involved; or (ii) some benefit for the population represented by the minor concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard treatment of the minor's condition; (h) the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity; (i) if during a performance study the minor reaches the age of legal competence to give informed consent as defined in the national law, his or her express informed consent shall be obtained before that subject can continue to participate in the performance study. 2. Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on minors, where there are no scientific grounds to expect that participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens involved. Article 62 Performance studies on pregnant or breastfeeding women A performance study on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met: (a) the performance study has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved; (b) if such a performance study has no direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, it can be conducted only if: (i) a performance study of comparable effectiveness cannot be carried out on women who are not pregnant or breastfeeding; (ii) the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding women or other women in relation to reproduction or other embryos, foetuses or children; and (iii) the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding woman concerned, her embryo, foetus or child after birth; (c) where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child; (d) no incentives or financial inducements are given to subjects, except for compensation for expenses and loss of earnings directly related to the participation in the performance study. Article 63 Additional national measures Member States may maintain additional measures regarding persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in performance studies, or persons in residential care institutions. Article 64 Performance studies in emergency situations 1. By way of derogation from point (f) of Article 58(5), from points (a) and (b) of Article 60(1) and from points (a) and (b) of Article 61(1), informed consent to participate in a performance study may be obtained, and information on the performance studies may be given, after the decision to include the subject in the performance study, provided that that decision is taken at the time of the first intervention on the subject, in accordance with the clinical performance study plan for that performance study and that all of the following conditions are fulfilled: (a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide prior informed consent and to receive prior information on the performance study; (b) there are scientific grounds to expect that participation of the subject in the performance study will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering and/or improving the health of the subject, or in the diagnosis of its condition; (c) it is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from his or her legally designated representative; (d) the investigator certifies that he or she is not aware of any objections to participate in the performance study previously expressed by the subject; (e) the performance study relates directly to the subject's medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative and to supply prior information, and the performance study is of such a nature that it may be conducted exclusively in emergency situations; (f) the performance study poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject's condition. 2. Following an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with Article 59 shall be sought to continue the participation of the subject in the performance study, and information on the performance study shall be given, in accordance with the following requirements: (a) regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator from his or her legally designated representative without undue delay and the information referred to in Article 59(2) shall be given as soon as possible to the subject and to his or her legally designated representative; (b) regarding other subjects, the informed consent shall be sought by the investigator without undue delay from the subject or his or her legally designated representative, whichever can be done sooner, and the information referred to in Article 59(2) shall be given as soon as possible to the subject or his or her legally designated representative, as applicable. For the purposes of point (b) where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the performance study shall be obtained from the subject as soon as he or she is capable of giving informed consent. 3. If the subject or, where applicable, his or her legally designated representative does not give consent, he or she shall be informed of the right to object to the use of data obtained from the performance study. Article 65 Damage compensation 1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a performance study conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk. 2. The sponsor and the investigator shall make use of the system referred to in paragraph 1 in the form appropriate for the Member State in which the performance study is conducted. Article 66 Application for performance studies 1. The sponsor of a performance study referred to in Article 58(1) and (2) shall enter and submit an application to the Member State(s) in which the performance study is to be conducted (referred to for the purposes of this Article as ‘Member State concerned’) accompanied by the documentation referred to in Sections 2 and 3 of Annex XIII and in Annex XIV. The application shall be submitted by means of the electronic system referred to in Article 69, which shall generate a Union-wide unique single identification number for the performance study which shall be used for all relevant communication in relation to that performance study. Within 10 days of receiving the application, the Member State concerned shall notify the sponsor as to whether the performance study falls within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter I of Annex XIV. 2. Within one week of any change occurring in relation to the documentation referred to in Chapter I of Annex XIV, the sponsor shall update the relevant data in the electronic system referred to in Article 69 and make that change to the documentation clearly identifiable. The Member State concerned shall be notified of the update by means of that electronic system. 3. Where the Member State concerned finds that the performance study applied for does not fall within the scope of this Regulation or that the application is not complete, it shall inform the sponsor thereof and shall set a time limit of maximum 10 days for the sponsor to comment or to complete the application by means of the electronic system referred to in Article 69. The Member State concerned may extend this period by a maximum of 20 days where appropriate. Where the sponsor has not provided comments nor completed the application within the time limit referred to in the first subparagraph, the application shall be deemed to have lapsed. Where the sponsor considers that the application falls under the scope of this Regulation and/or is complete but the Member State concerned does not agree, the application shall be considered to have been rejected. The Member State concerned shall provide for an appeal procedure in respect of such refusal. The Member State concerned shall notify the sponsor within five days of receipt of the comments or of the requested additional information, whether the performance study is considered as falling within the scope of this Regulation and the application is complete. 4. The Member State concerned may also extend the period referred to in paragraphs 1 and 3 each by a further five days. 5. For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the periods referred to in paragraphs 1, 3 and 4 respectively. 6. During the period when the application is being assessed the Member State may request additional information from the sponsor. The expiry of the deadline pursuant to the point (b) of paragraph 7 shall be suspended from the date of the first request until such time as the additional information has been received. 7. The sponsor may start the performance study in the following circumstances: (a) in the case of performance studies carried out pursuant to point (a) of Article 58(1) and where the specimen collection does not represent a major clinical risk to the subject of the study, unless otherwise stated by national law, immediately after the validation date of application described in paragraph 5 of this Article, provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study; (b) in the case of performance studies carried out pursuant to points (b) and (c) of Article 58(1) and Article 58(2) or performance studies other than those referred to in point (a) of this paragraph, as soon as the Member State concerned has notified the sponsor of its authorisation and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study. The Member State shall notify the sponsor of the authorisation within 45 days of the validation date of the application referred to in paragraph 5. The Member State may extend this period by a further 20 days for the purpose of consulting with experts. 8. The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the light of technical progress and global regulatory developments, the requirements laid down in Chapter I of Annex XIV. 9. In order to assure the uniform application of the requirements laid down in Chapter I of Annex XIV, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 67 Assessment by Member States 1. Member States shall ensure that the persons validating and assessing the application, or deciding on it, do not have conflicts of interest, are independent of the sponsor, the investigators involved and of natural or legal persons financing the performance study, as well as free of any other undue influence. 2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. 3. Member States shall assess whether the performance study is designed in such a way that potential remaining risks to subjects or third persons, after risk minimization, are justified, when weighed against the clinical benefits to be expected. They shall, while taking into account applicable CS or harmonised standards, examine in particular: (a) the demonstration of compliance of the device(s) for performance study with the applicable general safety and performance requirements, apart from the aspects covered by the performance study, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, in case of performance studies, the evaluation of the analytical performance, and in case of interventional clinical performance studies, the evaluation of the analytical performance, clinical performance and scientific validity, taking into consideration the state of the art; (b) whether the risk-minimisation solutions employed by the sponsor are described in harmonised standards and, in those cases where the sponsor does not use harmonised standards, whether the risk-minimisation solutions provide a level of protection that is equivalent to that provided by harmonised standards; (c) whether the measures planned for the safe installation, putting into service and maintenance of the device for performance study are adequate; (d) the reliability and robustness of the data generated in the performance study, taking account of statistical approaches, design of the performance study and methodological aspects, including sample size, comparator and endpoints; (e) whether the requirements of Annex XIV are met. 4. Member States shall refuse the authorisation of the performance study if: (a) the application dossier submitted pursuant to Article 66(3) remains incomplete; (b) the device or the submitted documents, especially the performance study plan and the investigator's brochure, do not correspond to the state of scientific knowledge, and the performance study, in particular, is not suitable for providing evidence for the safety, performance characteristics or benefit of the device on subjects or patients; (c) the requirements of Article 58 are not met; or (d) any assessment under paragraph 3 is negative. Member States shall provide for an appeal procedure in respect of a refusal pursuant to the first subparagraph. Article 68 Conduct of a performance study 1. The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the approved performance study plan. 2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the performance study is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the performance study including the following: (a) the objective and methodology of the performance study; and (b) the degree of deviation of the intervention from normal clinical practice. 3. All performance study information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection. 4. Appropriate technical and organisational measures shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves transmission over a network. 5. Member States shall inspect, at an appropriate level, performance study site(s) to check that performance studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan. 6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the study. Article 69 Electronic system on performance studies 1. The Commission shall, in collaboration with the Member States, set up, manage and maintain an electronic system: (a) to create the single identification numbers for performance studies referred to in Article 66(1); (b) to be used as an entry point for the submission of all applications or notifications for performance studies referred to in Articles 66, 70, 71 and 74 and for all other submission of data, or processing of data in this context; (c) for the exchange of information relating to performance studies in accordance with this Regulation between the Member States and between them and the Commission including the exchange of information referred to in to Articles 72 and 74; (d) for information to be provided by the sponsor in accordance with Article 73, including the performance study report and its summary as required in paragraph 5 of that Article; (e) for reporting on serious adverse events and device deficiencies, and related updates referred to in Article 76. 2. When setting up the electronic system referred to in paragraph 1 of this Article, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of the Council (26) as concerns performance studies of companion diagnostics. 3. The information referred to in point (c) of paragraph 1 shall only be accessible to the Member States and the Commission. The information referred to in the other points of that paragraph shall be accessible to the public, unless, for all or parts of that information, confidentiality of the information is justified on any of the following grounds: (a) protection of personal data in accordance with Regulation (EC) No 45/2001; (b) protection of commercially confidential information, especially in the investigators brochure, in particular through taking into account the status of the conformity assessment for the device, unless there is an overriding public interest in disclosure; (c) effective supervision of the conduct of the performance study by the Member State(s) concerned. 4. No personal data of subjects shall be publicly available. 5. The user interface of the electronic system referred to in paragraph 1 shall be available in all official languages of the Union. Article 70 Performance studies regarding devices bearing the CE marking 1. Where a performance study is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 18(1) (‘PMPF study’), and where the performance study would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days prior to its commencement by means of the electronic system referred to in Article 69. The sponsor shall include the documentation referred to in Section 2 of Part A of Annex XIII and in Annex XIV. Points (b) to (l) and (p) of Article 58(5), and Articles 71, 72 and 73 Article 76(5) and the relevant provisions of Annexes XIII and XIV shall apply to PMPF studies. 2. Where a performance study is to be conducted to assess, outside the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 18(1), Articles 58 to 77 shall apply. Article 71 Substantial modifications to performance studies 1. If a sponsor intends to introduce modifications to a performance study that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the study, it shall notify, within one week, by means of the electronic system referred to in Article 69, the Member State(s) in which the performance study is being or is to be conducted of the reasons for and the nature of those modifications. The sponsor shall include an updated version of the relevant documentation referred to in Annex XIV as part of the notification. Changes to the relevant documentation shall be clearly identifiable. 2. The Member State shall assess any substantial modification to the performance study in accordance with the procedure laid down in Article 67. 3. The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days after the notification referred to in paragraph 1, unless: (a) the Member State in which the performance study is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 67(4) or on considerations of public health, of subject and user safety or health, or of public policy; or (b) an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the performance study, which, in accordance with national law, is valid for that entire Member State. 4. The Member State(s) concerned may extend the period referred to in paragraph 3 by a further seven days, for the purpose of consulting with experts. Article 72 Corrective measures to be taken by Member States and information exchange between Member States on performance studies 1. Where a Member State in which a performance study is being or is to be conducted has grounds for considering that the requirements set out in this Regulation are not met, it may take at least any of the following measures on its territory: (a) revoke the authorisation for the performance study; (b) suspend or terminate the performance study; (c) require the sponsor to modify any aspect of the performance study. 2. Before the Member State concerned takes any of the measures referred to in paragraph 1 it shall, except where immediate action is required, ask the sponsor or the investigator or both for their opinion. That opinion shall be delivered within seven days. 3. Where a Member State has taken a measure referred to in paragraph 1 of this Article, or has refused a performance study, or has been notified by the sponsor of the early termination of a performance study on safety grounds, that Member State shall communicate the corresponding decision and the grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 69. 4. Where an application is withdrawn by the sponsor prior to a decision by a Member State, that information shall be made available through the electronic system referred to in Article 69 to all Member States and the Commission. Article 73 Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination 1. If the sponsor has temporarily halted a performance study or has terminated a performance study early, it shall inform within 15 days the Member States in which that performance study has been temporarily halted or terminated early, through the electronic system referred to in Article 69, of the temporary halt or early termination. In the event that the sponsor has temporarily halted or terminated early the performance study on safety grounds, it shall inform all Member States in which that performance study is being conducted thereof within 24 hours. 2. The end of a performance study shall be deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in the performance study plan. 3. The sponsor shall notify each Member State in which that performance study was being conducted of the end of that performance study in that Member State. That notification shall be made within 15 days of the end of the performance study in relation to that Member State. 4. If a study is conducted in more than one Member State, the sponsor shall notify all Member States in which that performance study was conducted of the end of the performance study in all Member States. That notification shall be made within 15 days of that end of the performance study. 5. Irrespective of the outcome of the performance study, within one year of the end of the performance study or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a performance study was conducted a performance study report as referred to in Section 2.3.3. of Part A of Annex XIII. The performance study report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. Both the report and summary shall be submitted by the sponsor by means of the electronic system referred to in Article 69. Where, for scientific reasons, it is not possible to submit the performance study report within one year of the end of the study, it shall be submitted as soon as it is available. In such case, the clinical performance study plan referred to in Section 2.3.2. of Part A of Annex XIII shall specify when the results of the performance study are going to be available, together with a justification. 6. The Commission shall issue guidelines regarding the content and structure of the summary of the performance study report. In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis. Those guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of performance studies. 7. The summary and the performance study report referred to in paragraph 5 of this Article shall become publicly accessible through the electronic system referred to in Article 69, at the latest when the device is registered in accordance with Article 26 and before it is placed on the market. In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission. If the device is not registered in accordance with Article 26 within one year of the summary and the performance study report having been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become publicly accessible at that point in time. Article 74 Coordinated assessment procedure for performance studies 1. By means of the electronic system referred to in Article 69, the sponsor of a performance study to be conducted in more than one Member State may submit, for the purpose of Article 66, a single application that, upon receipt, is transmitted electronically to all Member States in which the performance study is to be conducted. 2. The sponsor shall propose in the single application referred to in paragraph 1 that one of the Member States in which the performance study is to be conducted acts as coordinating Member State. The Member States in which the performance study is to be conducted shall, within six days of submission of the application, agree on one of them taking the role of the coordinating Member State. If they do not agree on a coordinating Member State, the coordinating Member State proposed by the sponsor shall assume that role. 3. Under the direction of the coordinating Member State referred to in paragraph 2, the Member States concerned shall coordinate their assessment of the application, in particular of the documentation referred to in Chapter I of Annex XIV. However, the completeness of the documentation referred to in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV and point (c) of Section 2.3.2. of Part A of Annex XIII shall be assessed separately by each Member State concerned in accordance with Article 66(1) to (5). 4. With regard to documentation other than that referred to in the second subparagraph of paragraph 3, the coordinating Member State shall: (a) within six days of receipt of the single application, notify the sponsor that it is the coordinating Member State (‘notification date’); (b) for the purpose of the validation of the application, take into account any considerations submitted within seven days of the notification date by any Member State concerned; (c) within 10 days of the notification date, assess whether the performance study falls within the scope of this Regulation and whether the application is complete and shall notify the sponsor accordingly. Article 66(1) and (3) to (5) shall apply to the coordinating Member State in relation to that assessment; (d) establish the results of its assessment in a draft assessment report to be transmitted within 26 days of the validation date to the Member States concerned. By day 38 after the validation date, the other Member States concerned shall transmit their comments and proposals on the draft assessment report and the underlying application to the coordinating Member State which shall take due account of those comments and proposals in its finalisation of the final assessment report, to be transmitted within 45 days of the validation date to the sponsor and the other Member States concerned. The final assessment report shall be taken into account by all Member States concerned when deciding on the sponsor's application in accordance with Article 66(7). 5. As regards the assessment of the documentation referred to in the second subparagraph of paragraph 3, each Member State concerned may request, on a single occasion, additional information from the sponsor. The sponsor shall submit the requested additional information within the period set by the Member State concerned, which shall not exceed 12 days from the receipt of the request. The expiry of the last deadline pursuant to point (d) of paragraph 4 shall be suspended from the date of the request until such time as the additional information has been received. 6. For class C and D devices, the coordinating Member State may also extend the periods referred to in paragraph 4 by a further 50 days, for the purpose of consulting with experts. 7. The Commission may, by means of implementing acts, further specify the procedures and timescales for coordinated assessments to be taken into account by Member States concerned when deciding on the sponsor's application. Such implementing acts may also set out the procedures and timescales for coordinated assessment in the case of substantial modifications pursuant to paragraph 12 of this Article and in the case of reporting of adverse events pursuant to Article 76(4) and in the case of performance studies involving companion diagnostics, where the medicinal products are under a concurrent coordinated assessment of a clinical trial under Regulation (EU) No 536/2014. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 8. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the conduct of the performance study is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of all Member State(s) concerned. Notwithstanding the first subparagraph, a Member State concerned may only disagree with the conclusion of the coordinating Member State concerning the area of coordinated assessment on the following grounds: (a) when it considers that participation in the performance study would lead to a subject receiving treatment inferior to that received in normal clinical practice in that Member State concerned; (b) infringement of national law; or (c) considerations as regards subject safety and data reliability and robustness submitted under point (d) of paragraph 4. Where one of the Member States concerned disagrees with the conclusion on the basis of the second subparagraph of this paragraph, it shall communicate its disagreement, together with a detailed justification, through the electronic system referred to in Article 69 to the Commission, to all other Member States concerned, and to the sponsor. 9. Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the performance study is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned. 10. A Member State concerned shall refuse to authorise a performance study if it disagrees with the conclusion of the coordinating Member State as regards any of the grounds referred to in the second subparagraph of paragraph 8, or if it finds, on duly justified grounds, that the aspects addressed in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV are not complied with, or where an ethics committee has issued a negative opinion in relation to that performance study which is valid in accordance with national law for that entire Member State. That Member State shall provide for an appeal procedure in respect of such refusal. 11. Each Member State concerned shall notify the sponsor through the electronic system referred to in Article 69 as to whether the performance study is authorised, whether it is authorised subject to conditions, or whether authorisation has been refused. Notification shall be done by way of one single decision within five days of the transmission, pursuant to point (d) of paragraph 4 of this Article, by the coordinating Member State of the final assessment report. Where an authorisation of a performance study is subject to conditions, those conditions may only be such that, by their nature, they cannot be fulfilled at the time of that authorisation. 12. Any substantial modifications as referred to in Article 71 shall be notified to the Member States concerned by means of the electronic system referred to in Article 69. Any assessment as to whether there are grounds for disagreement as referred to in the second subparagraph of paragraph 8 of this Article shall be carried out under the direction of the coordinating Member State, except for substantial modifications concerning sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV and point (c) of Section 2.3.2 of Part A of Annex XIII, which shall be assessed separately by each Member State concerned. 13. The Commission shall provide administrative support to the coordinating Member State in the accomplishment of its tasks under this Chapter. 14. The procedure set out in this Article shall, until 27 May 2029, be applied only by those of the Member States in which the performance studies are to be conducted which have agreed to apply it. After 27 May 2029, all Member States shall be required to apply that procedure. Article 75 Review of the coordinated assessment procedure By 27 May 2028, the Commission shall submit to the European Parliament and to the Council a report on the experience gained from the application of Article 74 and, if necessary, propose a review of Article 74(14) and point (g) of Article 113(3). Article 76 Recording and reporting of adverse events that occur during performance studies 1. The sponsor shall fully record all of the following: (a) any adverse event of a type identified in the performance study plan as being critical to the evaluation of the results of that performance study; (b) any serious adverse event; (c) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate; (d) any new findings in relation to any event referred to in points (a) to (c). 2. The sponsor shall report without delay to all Member States in which a performance study is being conducted all of the following by means of the electronic system referred to in Article 69: (a) any serious adverse event that has a causal relationship with the device, the comparator or the study procedure or where such causal relationship is reasonably possible; (b) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate; (c) any new findings in relation to any event referred to in points (a) and (b). The period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report. Upon request by any Member State in which the performance study is being conducted, the sponsor shall provide all information referred to in paragraph 1. 3. The sponsor shall also report to the Member States in which the performance study is being conducted any event referred to in paragraph 2 of this Article that occurred in third countries in which a performance study is performed under the same clinical performance study plan as the one applying to a performance study covered by this Regulation by means of the electronic system referred to in Article 69. 4. In the case of a performance study for which the sponsor has used the single application referred to in Article 74, the sponsor shall report any event as referred to in paragraph 2 of this Article by means of the electronic system referred to in Article 69. Upon receipt, this report shall be transmitted electronically to all Member States in which the performance study is being conducted. Under the direction of the coordinating Member State referred to in Article 74(2), the Member States shall coordinate their assessment of serious adverse events and device deficiencies to determine whether to modify, suspend or terminate the performance study or whether to revoke the authorisation for that performance study. This paragraph shall not affect the rights of the other Member States to perform their own evaluation and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating Member State and the Commission shall be kept informed of the outcome of any such evaluation and the adoption of any such measures. 5. In the case of PMPF studies referred to in Article 70(1), the provisions on vigilance laid down in Articles 82 to 85 and in the implementing acts adopted pursuant to Article 86 shall apply instead of this Article. 6. Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the serious adverse event and the preceding performance study has been established. Article 77 Implementing acts The Commission may, by means of implementing acts, establish the detailed arrangements and procedural aspects necessary for the implementation of this Chapter, as regards the following: (a) harmonised electronic forms for the application for performance studies and their assessment as referred to in Articles 66 and 74, taking into account specific categories or groups of devices; (b) the functioning of the electronic system referred to in Article 69; (c) harmonised electronic forms for the notification of PMPF studies as referred to in Article 70(1), and of substantial modifications as referred to in Article 71; (d) the exchange of information between Member States as referred to in Article 72; (e) harmonised electronic forms for the reporting of serious adverse events and device deficiencies as referred to in Article 76; (f) the timelines for the reporting of serious adverse events and device deficiencies, taking into account the severity of the event to be reported as referred to in Article 76; (g) uniform application of the requirements regarding the clinical evidence/data needed to demonstrate compliance with the general safety and performance requirements set out in Annex I. The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in Article 107(3). CHAPTER VII POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE Section 1 Post-market surveillance Article 78 Post-market surveillance system of the manufacturer 1. For each device manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer's quality management system referred to in Article 10(8). 2. The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions. 3. Data gathered by the manufacturer's post-market surveillance system shall in particular be used: (a) to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I; (b) to update the design and manufacturing information, the instructions for use and the labelling; (c) to update the performance evaluation; (d) to update the summary of safety and performance referred to in Article 29; (e) for the identification of needs for preventive, corrective or field safety corrective action; (f) for the identification of options to improve the usability, performance and safety of the device; (g) when relevant, to contribute to the post-market surveillance of other devices; and (h) to detect and report trends in accordance with Article 83. The technical documentation shall be updated accordingly. 4. If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 82. Article 79 Post-market surveillance plan The post-market surveillance system referred to in Article 78 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1 of Annex III. The post-market surveillance plan shall be part of the technical documentation specified in Annex II. Article 80 Post-market surveillance report Manufacturers of class A and B devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the notified body and the competent authority upon request. Article 81 Periodic safety update report 1. Manufacturers of class C and class D devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out: (a) the conclusions of the benefit-risk determination; (b) the main findings of the PMPF; and (c) the volume of sales of the device and an estimate of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device. Manufacturers of class C and D devices shall update the PSUR at least annually. That PSUR shall be part of the technical documentation as specified in Annexes II and III. 2. Manufacturers of class D devices shall submit PSUR by means of the electronic system referred to in Article 87 to the notified body involved in the conformity assessment of such devices in accordance with Article 48. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSUR and the evaluation by the notified body shall be made available to competent authorities through that electronic system. 3. For class C devices, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities. Section 2 Vigilance Article 82 Reporting of serious incidents and field safety corrective actions 1. Manufacturers of devices, made available on the Union market, other than devices for performance study, shall report, to the relevant competent authorities, in accordance with Articles 87(5) and (7), the following: (a) any serious incident involving devices made available on the Union market, except expected erroneous results which are clearly documented and quantified in the product information and in the technical documentation and are subject to trend reporting pursuant to Article 83; (b) any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country. The reports referred to in the first subparagraph shall be submitted through the electronic system referred to in Article 87. 2. As a general rule, the period for the reporting referred to in paragraph 1 shall take account of the severity of the serious incident. 3. Manufacturers shall report any serious incident as referred to in point (a) immediately after they have established a causal relationship between that incident and their device or that such causal relationship is reasonably possible, and not later than 15 days after they become aware of the incident. 4. Notwithstanding paragraph 3, in the event of a serious public health threat the report referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat. 5. Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person's state of health the report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident. 6. Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is incomplete followed up by a complete report. 7. If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about whether the incident is reportable, it shall nevertheless submit a report within the timeframe required in accordance with paragraphs 2 to 5. 8. Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in point (b) of paragraph 1, in advance of the field safety corrective action being undertaken. 9. For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident reports, on condition that the coordinating competent authority referred to in Article 84(9), in consultation with the competent authorities referred to in points (a) and (b) of Article 87(8), has agreed with the manufacturer on the format, content and frequency of the periodic summary reporting. Where a single competent authority is referred to in points (a) and (b) of Article 87(8), the manufacturer may provide periodic summary reports following agreement with that competent authority. 10. The Member States shall take appropriate measures such as organising targeted information campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent authorities suspected serious incidents referred to in point (a) of paragraph 1. The competent authorities shall record centrally at national level reports they receive from healthcare professionals, users and patients. 11. Where a competent authority of a Member State obtains such reports on suspected serious incidents referred to in point (a) of paragraph 1 from healthcare professionals, users or patients, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the suspected serious incident without delay. Where the manufacturer of the device concerned considers that the incident is a serious incident, it shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the competent authority of the Member State in which that serious incident occurred and shall take the appropriate follow-up action in accordance with Article 84. Where the manufacturer of the device concerned considers that the incident is not a serious incident or is to be treated as an increase in expected erroneous results, which will be covered by trend reporting in accordance with to Article 83, it shall provide an explanatory statement. If the competent authority does not agree with the conclusion of the explanatory statement, it may require the manufacturer to provide a report in accordance with paragraphs 1 to 5 of this Article and require it to ensure that appropriate follow-up action is taken in accordance with Article 84. Article 83 Trend reporting 1. Manufacturers shall report by means of the electronic system referred to in Article 87 any statistically significant increase in the frequency or severity of incidents that are not serious incidents that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons or of any significant increase in expected erroneous results established in comparison to the stated performance of the device as referred to in points (a) and (b) of Section 9.1 of Annex I and specified in the technical documentation and product information. The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such events or change in performance, as well as the observation period, in the post-market surveillance plan referred to in Article 79. 2. The competent authorities may conduct their own assessments on the trend reports referred to in paragraph 1 and require the manufacturer to adopt appropriate measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. Each competent authority shall inform the Commission, the other competent authorities and the notified body that issued the certificate, of the results of such assessment and of the adoption of such measures. Article 84 Analysis of serious incidents and field safety corrective actions 1. Following the reporting of a serious incident pursuant to Article 82(1), the manufacturer shall, without delay, perform the necessary investigations in relation to the serious incident and the devices concerned. This shall include risk assessment of the incident and field safety corrective action taking into account the criteria as referred to in paragraph 3 of this Article as appropriate. The manufacturer shall co-operate with the competent authorities and where relevant with the notified body concerned during the investigations referred to in the first subparagraph and shall not perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action. 2. Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory, or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 82 is evaluated centrally at national level by their competent authority, if possible together with the manufacturer, and, where relevant, the notified body concerned. 3. In the context of the evaluation referred to in paragraph 2, the competent authority shall evaluate the risks arising from the reported serious incident and evaluate any field safety corrective actions, taking into account the protection of public health and criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of direct or indirect harm, the severity of that harm, the clinical benefit of the device, intended and potential users, and the population affected. The competent authority shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for, and kind of, any other corrective action, in particular taking into account the principle of inherent safety contained in Annex I. Upon request by the national competent authority, manufacturers shall provide for all documents necessary for the risk assessment. 4. The competent authority shall monitor the manufacturer's investigation of a serious incident. Where necessary, a competent authority may intervene in a manufacturer's investigation or initiate an independent investigation. 5. The manufacturer shall provide a final report to the competent authority setting out its findings from the investigation by means of the electronic system referred to in Article 87. The report shall set out conclusions and where relevant indicate corrective actions to be taken. 6. In the case of companion diagnostic, the evaluating competent authority or the coordinating competent authority referred to in paragraph 9 of this Article shall, depending on whether the relevant competent authority of the Member State that authorised the medicinal products or the EMA was consulted by the notified body in accordance with the procedures set out in Section 5.2 of Annex IX and Section 3.11 of Annex X, inform that national competent authority or the EMA, as appropriate. 7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the evaluating competent authority shall, through the electronic system referred to in Article 87, inform without delay the other competent authorities of the corrective action taken or envisaged by the manufacturer or required of it to minimise the risk of recurrence of the serious incident, including information on the underlying serious incidents and the outcome of its assessment. 8. The manufacturer shall ensure that information about the field safety corrective action taken is brought without delay to the attention of users of the device in question by means of a field safety notice. The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken. Except in cases of urgency, the content of the draft field safety notice shall be submitted to the evaluating competent authority or, in the cases referred to in paragraph 9, to the coordinating competent authority to allow them to make comments. Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States. The field safety notice shall allow the correct identification of the device or devices involved, in particular by including the relevant UDIs, and the correct identification, in particular by including the SRN, if already issued, of the manufacturer that has undertaken the field safety corrective action. The field safety notice shall explain, in a clear manner, without understating the level of risk, the reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or other persons and shall clearly indicate all the actions to be taken by users. The manufacturer shall enter the field safety notice in the electronic system referred to in Article 87 through which that notice shall be accessible to the public. 9. The competent authorities shall actively participate in a procedure in order to coordinate their assessments referred to in paragraph 3 in the following cases: (a) where there is concern regarding a particular serious incident or cluster of serious incidents relating to the same device or type of device of the same manufacturer in more than one Member State; (b) where the appropriateness of a field safety corrective action that is proposed by a manufacturer in more than one Member State is in question. That coordinated procedure shall cover the following: — designation of a coordinating competent authority on a case by case basis, when required; — defining the coordinated assessment process, including the tasks and responsibilities of the coordinating competent authority and the involvement of other competent authorities. Unless otherwise agreed between the competent authorities, the coordinating competent authority shall be the competent authority of the Member State in which the manufacturer has its registered place of business. The coordinating competent authority shall, through the electronic system referred to in Article 87, inform the manufacturer, the other competent authorities and the Commission that it has assumed the role of coordinating authority. 10. The designation of a coordinating competent authority shall not affect the rights of the other competent authorities to perform their own assessment and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. The coordinating competent authority and the Commission shall be kept informed of the outcome of any such assessment and the adoption of any such measures. 11. The Commission shall provide administrative support to the coordinating competent authority in the accomplishment of its tasks under this Chapter. Article 85 Analysis of vigilance data The Commission shall, in collaboration with the Member States, put in place systems and processes to actively monitor the data available in the electronic system referred to in Article 87, in order to identify trends, patterns or signals in the data that may reveal new risks or safety concerns. Where a previously unknown risk is identified or the frequency of an anticipated risk significantly and adversely changes the benefit-risk determination, the competent authority or, where appropriate, the coordinating competent authority shall inform the manufacturer, or where applicable the authorised representative, which shall then take the necessary corrective actions. Article 86 Implementing acts The Commission may, by means of implementing acts, and after consultation of the MDCG, adopt the detailed arrangements and procedural aspects necessary for the implementation of Articles 80 to 85 and 87 as regards the following: (a) the typology of serious incidents and field safety corrective actions in relation to specific devices, or categories or groups of devices; (b) the reporting of serious incidents and field safety corrective actions and field safety notices, and the provision of periodic summary reports, post-market surveillance reports, PSURs and trend reports by manufacturers as referred to in Articles 80, 81, 82, 83 and 84 respectively; (c) standard structured forms for electronic and non-electronic reporting, including a minimum data set for reporting of suspected serious incidents by healthcare professionals, users and patients; (d) timelines for the reporting of field safety corrective actions, and for the provision by manufacturers of periodic summary reports and trend reports, taking into account the severity of the incident to be reported as referred to in Article 82; (e) harmonised forms for the exchange of information between competent authorities as referred to in Article 84; (f) procedures for the designation of a coordinating competent authority; the coordinated evaluation process, including tasks and responsibilities of the coordinating competent authority and involvement of other competent authorities in this process. The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 87 Electronic system on vigilance and post-market surveillance 1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information: (a) reports by manufacturers on serious incidents and field safety corrective actions referred to in Article 82(1) and Article 84(5); (b) the periodic summary reports by manufacturers referred to in Article 82(9); (c) the reports by manufacturers on trends referred to in Article 83; (d) the PSURs referred to in Article 81; (e) the field safety notices by manufacturers referred to in Article 84(8); (f) the information to be exchanged between the competent authorities of the Member States and between them and the Commission in accordance with Article 84(7) and (9). That electronic system shall include relevant links to the UDI database. 2. The information referred to in paragraph 1 of this Article shall be made available through the electronic system to the competent authorities of the Member States and to the Commission. The notified bodies shall also have access to that information to the extent that it relates to devices for which they issued a certificate in accordance with Article 49. 3. The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to the electronic system referred to in paragraph 1. 4. On the basis of arrangements between the Commission and competent authorities of third countries or international organisations, the Commission may grant those competent authorities or international organisations access to the electronic system referred to in paragraph 1 at the appropriate level. Those arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent to those applicable in the Union. 5. The reports on serious incidents referred to in point (a) of Article 82(1), shall be automatically transmitted, upon receipt, via the electronic system referred to in paragraph 1 of this Article, to the competent authority of the Member State in which the incident occurred. 6. The trend reports referred to in Article 83(1) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the Member States in which the incidents occurred. 7. The reports on field safety corrective actions referred to in point (b) of Article 82(1) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the following Member States: (a) the Member State in which the field safety corrective action is being or is to be undertaken; (b) the Member State in which the manufacturer has its registered place of business. 8. The periodic summary reports referred to in Article 82(9) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authority of: (a) the Member State or Member States participating in the coordination procedure in accordance with Article 84(9) and which have agreed on the periodic summary report; (b) the Member State in which the manufacturer has its registered place of business. 9. The information referred to in paragraphs 5 to 8 of this Article shall be automatically transmitted, upon receipt, through the electronic system referred to in paragraph 1 of this Article, to the notified body that issued the certificate for the device in question in accordance with Article 51. Section 3 Market surveillance Article 88 Market surveillance activities 1. The competent authorities shall perform appropriate checks on the conformity characteristics and performance of devices including, where appropriate, a review of documentation and physical or laboratory checks on the basis of adequate samples. The competent authorities shall, in particular, take account of established principles regarding risk assessment and risk management, vigilance data and complaints. 2. The competent authorities shall draw up annual surveillance activity plans and allocate a sufficient number of material and competent human resources in order to carry out those activities taking into account the European market surveillance programme developed by the MDCG pursuant to Article 99 and local circumstances. 3. In order to fulfil the obligations laid down in paragraph 1, the competent authorities: (a) may require economic operators to, inter alia, make available the documentation and information necessary for the purpose of carrying out the authorities' activities and, where justified, to provide the necessary samples of devices or access to devices free of charge; and (b) shall carry out both announced and, if necessary, unannounced inspections of the premises of economic operators, as well as suppliers and/or subcontractors, and, where necessary, at the facilities of professional users. 4. The competent authorities shall prepare an annual summary of the results of their surveillance activities and make it accessible to other competent authorities by means of the electronic system referred to in Article 95. 5. The competent authorities may confiscate, destroy or otherwise render inoperable devices that present an unacceptable risk or falsified devices where they deem it necessary to do so in the interests of the protection of public health. 6. Following each inspection carried out for the purposes referred to in paragraph 1, the competent authority shall draw up a report on the findings of the inspection that concern compliance with the legal and technical requirements applicable under this Regulation. The report shall set out any corrective actions needed. 7. The competent authority which carried out the inspection shall communicate the content of the report referred to in paragraph 6 of this Article to the economic operator that has been the subject of the inspection. Before adopting the final report, the competent authority shall give that economic operator the opportunity to submit comments. That final inspection report shall be entered in the electronic system provided for in Article 95. 8. The Member States shall review and assess the functioning of their market surveillance activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission. Each Member State shall make a summary of the results accessible to the public by means of the electronic system referred to in Article 95. 9. The competent authorities of the Member States shall coordinate their market surveillance activities, cooperate with each other and share with each other and with the Commission the results thereof, to provide for a harmonised and high level of market surveillance in all Member States. Where appropriate, the competent authorities of the Member States shall agree on work-sharing, joint market surveillance activities and specialisation. 10. Where more than one authority in a Member State is responsible for market surveillance and external border controls, those authorities shall cooperate with each other, by sharing information relevant to their role and functions. 11. Where appropriate, the competent authorities of the Member States shall cooperate with the competent authorities of third countries with a view to exchanging information and technical support and promoting activities relating to market surveillance. Article 89 Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance Where the competent authorities of a Member State, based on data obtained by vigilance or market surveillance activities or on other information, have reason to believe that a device: (a) may present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health; or (b) otherwise does not comply with the requirements laid down in this Regulation, they shall carry out an evaluation of the device concerned covering all requirements laid down in this Regulation relating to the risk presented by the device or to any other non-compliance of the device. The relevant economic operators shall cooperate with the competent authorities. Article 90 Procedure for dealing with devices presenting an unacceptable risk to health and safety 1. Where, having performed an evaluation pursuant to Article 89, the competent authorities find that the device presents an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, they shall without delay require the manufacturer of the devices concerned, its authorised representative and all other relevant economic operators to take all appropriate and duly justified corrective action to bring the device into compliance with the requirements of this Regulation relating to the risk presented by the device and, in a manner that is proportionate to the nature of the risk, to restrict the making available of the device on the market, to subject the making available of the device to specific requirements, to withdraw the device from the market, or to recall it, within a reasonable period that is clearly defined and communicated to the relevant economic operator. 2. The competent authorities shall, without delay, notify the Commission, the other Member States and, where a certificate has been issued in accordance with Article 51 for the device concerned, the notified body that issued that certificate, of the results of the evaluation and of the actions which they have required the economic operators to take, by means of the electronic system referred to in Article 95. 3. The economic operators as referred to in paragraph 1 shall, without delay, ensure that all appropriate corrective action is taken throughout the Union in respect of all the devices concerned that they have made available on the market. 4. Where the economic operator as referred to in paragraph 1 does not take adequate corrective action within the period referred to in paragraph 1, the competent authorities shall take all appropriate measures to prohibit or restrict the making available of the device on their national market, to withdraw the device from that market or to recall it. The competent authorities shall notify the Commission, the other Member States and the notified body referred to in paragraph 2 of this Article, without delay, of those measures, by means of the electronic system referred to in Article 95. 5. The notification referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification and tracing of the non-compliant device, the origin of the device, the nature of and the reasons for the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. 6. Member States other than the Member State initiating the procedure shall, without delay, inform the Commission and the other Member States, by means of the electronic system referred to in Article 95, of any additional relevant information at their disposal relating to the non-compliance of the device concerned and of any measures adopted by them in relation to the device concerned. In the event of disagreement with the notified national measure, they shall, without delay, inform the Commission and the other Member States of their objections, by means of the electronic system referred to in Article 95. 7. Where, within two months of receipt of the notification referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of any measures taken by a Member State, those measures shall be deemed to be justified. In that case, all Member States shall ensure that corresponding appropriate restrictive or prohibitive measures, including withdrawing, recalling or limiting the availability of the device on their national market are taken without delay in respect of the device concerned. Article 91 Procedure for evaluating national measures at Union level 1. Where, within two months of receipt of the notification referred to in Article 90(4), objections are raised by a Member State against a measure taken by another Member State, or where the Commission considers the measure to be contrary to Union law, the Commission shall, after consulting the competent authorities concerned and, where necessary, the economic operators concerned, evaluate that national measure. On the basis of the results of that evaluation, the Commission may decide, by means of implementing acts, whether or not the national measure is justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 2. Where the Commission considers the national measure to be justified as referred to in paragraph 1 of this Article, the second subparagraph of Article 90(7) shall apply. If the Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure. Where the Commission does not adopt a decision pursuant to paragraph 1 of this Article within eight months of receipt of the notification referred to in Article 90(4), the national measure shall be considered to be justified. 3. Where a Member State or the Commission considers that the risk to health and safety emanating from a device cannot be mitigated satisfactorily by means of measures taken by the Member State or Member States concerned, the Commission, at the request of a Member State or on its own initiative, may take, by means of implementing acts, the necessary and duly justified measures to ensure the protection of health and safety, including measures restricting or prohibiting the placing on the market and putting into service of the device concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 92 Other non-compliance 1. Where, having performed an evaluation pursuant to Article 89, the competent authorities of a Member State find that a device does not comply with the requirements laid down in this Regulation but does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, they shall require the relevant economic operator to bring the non-compliance concerned to an end within a reasonable period that is clearly defined and communicated to the economic operator and that is proportionate to the non-compliance. 2. Where the economic operator does not bring the non-compliance to an end within the period referred to in paragraph 1 of this Article, the Member State concerned shall without delay take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market. That Member State shall inform the Commission and the other Member States without delay of those measures, by means of the electronic system referred to in Article 95. 3. In order to ensure the uniform application of this Article, the Commission may, by means of implementing acts, specify appropriate measures to be taken by competent authorities to address given types of non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 93 Preventive health protection measures 1. Where a Member State, after having performed an evaluation, which indicates a potential risk related to a device or a specific category or group of devices considers that, in order to protect the health and safety of patients, users or other persons or other aspects of public health, the making available on the market or putting into service of a device or a specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled, it may take any necessary and justified measures. 2. The Member State referred to in paragraph 1 shall immediately notify the Commission and all other Member States, giving the reasons for its decision, by means of the electronic system referred to in Article 95. 3. The Commission, in consultation with the MDCG and, where necessary, the economic operators concerned, shall assess the national measures taken. The Commission may decide, by means of implementing acts, whether the national measures are justified or not. In the absence of a Commission decision within six months of their notification, the national measures shall be considered to be justified. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 4. Where the assessment referred to in paragraph 3 of this Article demonstrates that the making available on the market or putting into service of a device, specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled in all Member States in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission may adopt implementing acts) to take the necessary and duly justified measures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 94 Good administrative practice 1. Any measure adopted by the competent authorities of the Member States pursuant to Articles 90 to 93 shall state the exact grounds on which it is based. Where such a measure is addressed to a specific economic operator, the competent authority shall notify without delay the economic operator concerned of that measure, and shall at the same time inform that economic operator of the remedies available under the law or the administrative practice of the Member State concerned and of the time limits to which such remedies are subject. Where the measure is of general applicability, it shall be appropriately published. 2. Except in cases where immediate action is necessary for reasons of unacceptable risk to human health or safety, the economic operator concerned shall be given the opportunity to make submissions to the competent authority within an appropriate period of time that is clearly defined before any measure is adopted. Where action has been taken without the economic operator having had the opportunity to make submissions as referred to in the first subparagraph, it shall be given the opportunity to make submissions as soon as possible and the action taken shall be reviewed promptly thereafter. 3. Any measure adopted shall be immediately withdrawn or amended upon the economic operator's demonstrating that it has taken effective corrective action and that the device is in compliance with the requirements of this Regulation. 4. Where a measure adopted pursuant to Articles 90 to 93 concerns a device for which a notified body has been involved in the conformity assessment, the competent authorities shall by means of the electronic system referred to in Article 95 inform the relevant notified body and the authority responsible for the notified body of the measure taken. Article 95 Electronic system on market surveillance 1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information: (a) summaries of the results of the surveillance activities referred to in Article 88(4); (b) the final inspection report as referred to in Article 88(7); (c) information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article 90(2), (4) and (6); (d) information in relation to non-compliance of products as referred to in Article 92(2); (e) information in relation to the preventive health protection measures referred to in Article 93(2); (f) summaries of the results of the reviews and assessments of the market surveillance activities of the Member States referred to in Article 88(8). 2. The information referred to in paragraph 1 of this Article shall be immediately transmitted through the electronic system to all competent authorities concerned and, where applicable, to the notified body that issued a certificate in accordance with Article 51 for the device concerned and be accessible to the Member States and to the Commission. 3. Information exchanged between Member States shall not be made public where to do so might impair market surveillance activities and co-operation between Member States. CHAPTER VIII COOPERATION BETWEEN MEMBER STATES, MEDICAL DEVICE COORDINATION GROUP, EU REFERENCE LABORATORIES AND DEVICE REGISTERS Article 96 Competent authorities The Member States shall designate the competent authority or authorities responsible for the implementation of this Regulation. They shall entrust their authorities with the powers, resources, equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation. The Member States shall communicate the names and contact details of the competent authorities to the Commission which shall publish a list of competent authorities. Article 97 Cooperation 1. The competent authorities of the Member States shall cooperate with each other and with the Commission. The Commission shall provide for the organisation of exchanges of information necessary to enable this Regulation to be applied uniformly. 2. Member States shall with the support of the Commission participate, where appropriate, in initiatives developed at international level with the aim of ensuring cooperation between regulatory authorities in the field of medical devices. Article 98 Medical Device Coordination Group The Medical Device Coordination Group (MDCG) established in accordance with the conditions and detailed arrangements referred to in Article 103 and 107 of Regulation (EU) 2017/745 shall carry out, with the support of the Commission as provided in Article 104 of Regulation (EU) 2017/745, the tasks conferred on it under this Regulation as well as those under Regulation (EU) 2017/745. Article 99 Tasks of the MDCG Under this Regulation, the MDCG shall have the following tasks: (a) to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV; (b) to advise the Commission, at its request, in matters concerning the coordination group of notified bodies as established pursuant to Article 45; (c) to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of performance evaluations by manufacturers, assessment by notified bodies and vigilance activities; (d) to contribute to the continuous monitoring of technical progress and assessment of whether the general safety and performance requirements laid down in this Regulation and Regulation (EU) 2017/745 are adequate to ensure safety and performance of devices, and thereby contribute to identifying whether there is a need to amend Annex I to this Regulation; (e) to contribute to the development of device standards and of CS; (f) to assist the competent authorities of the Member States in their coordination activities in particular in the fields of classification and the determination of the regulatory status of devices, performance studies, vigilance and market surveillance including the development and maintenance of a framework for a European market surveillance programme with the objective of achieving efficiency and harmonisation of market surveillance in the Union, in accordance with Article 88; (g) to provide advice, either on its own initiative or at request of the Commission, in the assessment of any issue related to the implementation of this Regulation; (h) to contribute to harmonised administrative practice with regard to devices in the Member States. Article 100 The European Union reference laboratories 1. For specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices, the Commission may designate, by means of implementing acts, one or more European Union reference laboratories (the ‘EU reference laboratories’), that satisfy the criteria set out in paragraph 4. The Commission shall only designate the EU reference laboratories for which a Member State or the Commission's Joint Research Centre have submitted an application for designation. 2. Within the scope of their designation, the EU reference laboratories shall, where appropriate, have the following tasks: (a) to verify the performance claimed by the manufacturer and the compliance of class D devices with the applicable CS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as provided for in the third subparagraph of Article 48(3); (b) to carry out appropriate tests on samples of manufactured class D devices or batches of class D devices, as provided for in the Section 4.12 of Annex IX and in Section 5.1 of Annex XI; (c) to provide scientific and technical assistance to the Commission, the MDCG, the Member States and notified bodies in relation to the implementation of this Regulation; (d) to provide scientific advice regarding the state of the art in relation to specific devices, or a category or group of devices; (e) to set up and manage a network of national reference laboratories after consulting with the national authorities and publish a list of the participating national reference laboratories and their respective tasks; (f) to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures and market surveillance; (g) to collaborate with notified bodies in the development of best practices for the performance of conformity assessment procedures; (h) to provide recommendations on suitable reference materials and reference measurement procedures of higher metrological order; (i) to contribute to the development of CS and of international standards; (j) to provide scientific opinions in response to consultations by notified bodies in accordance with this Regulation and publish them by electronic means having considered national provisions on confidentiality. 3. At the request of a Member State, the Commission may also designate the EU reference laboratories where that Member State wishes to have recourse to such laboratories to ensure the verification of the performance claimed by the manufacturer and the compliance of class C devices with the applicable CS when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. 4. The EU reference laboratories shall satisfy the following criteria: (a) have adequate and appropriately qualified staff with adequate knowledge and experience in the field of the in vitro diagnostic medical devices for which they are designated; (b) possess the necessary equipment and reference material to carry out the tasks assigned to them; (c) have the necessary knowledge of international standards and best practices; (d) have an appropriate administrative organisation and structure; (e) ensure that their staff observe the confidentiality of information and data obtained in carrying out their tasks; (f) act in the public interest and in an independent manner; (g) ensure that their staff do not have financial or other interests in the in vitro diagnostic medical device industry which could affect their impartiality, declare any other direct and indirect interests they may have in the in vitro diagnostic medical device industry and update this declaration whenever a relevant change occurs. 5. The EU reference laboratories shall form a network in order to coordinate and harmonise their working methods as regards testing and assessment. That coordination and harmonisation shall involve: (a) applying coordinated methods, procedures and processes; (b) agreeing on the use of same reference materials and common test samples and seroconversion panels; (c) establishing common assessment and interpretation criteria; (d) using common testing protocols and assessing the test results using standardised and coordinated evaluation methods; (e) using standardised and coordinated test reports; (f) developing, applying and maintaining a peer review system; (g) organizing regular quality assessment tests (including mutual checks on the quality and comparability of test results); (h) agreeing on joint guidelines, instructions, procedural instructions or standard operational procedures; (i) coordinating the introduction of testing methods for new technologies and according to new or amended CS; (j) reassessing the state of the art on the basis of comparative test results or by further studies, as requested by a Member State or by the Commission. 6. The EU reference laboratories may be granted a Union financial contribution. The Commission may adopt, by means of implementing acts, the detailed arrangements and the amount of a Union financial contribution to the EU reference laboratories, taking into account the objectives of health and safety protection, support of innovation and cost-effectiveness. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 7. Where notified bodies or Member States request scientific or technical assistance or a scientific opinion from an EU reference laboratory, they may be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task according to predetermined and transparent terms and conditions. 8. The Commission shall specify by means of implementing acts: (a) detailed rules to facilitate the application of paragraph 2 of this Article and detailed rules to ensure compliance with the criteria referred to in paragraph 4 of this Article. (b) the structure and the level of the fees referred to in paragraph 7 of this Article which may be levied by an EU reference laboratory for providing scientific opinions in response to consultations by notified bodies and Member States in accordance with this Regulation, taking into account the objectives of human health and safety protection, support of innovation and cost-effectiveness. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). 9. The EU reference laboratories shall be subject to controls, including on-site visits and audits, by the Commission to verify compliance with the requirements of this Regulation. If those controls find that an EU reference laboratory is not complying with the requirements for which it has been designated, the Commission, by means of implementing acts, shall take appropriate measures, including the restriction, suspension or withdrawal of the designation. 10. The provisions in Article 107(1) of Regulation (EU) 2017/745 shall apply to the staff of the EU reference laboratories. Article 101 Device registers and databanks The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers and databanks for specific types of devices setting common principles to collect comparable information. Such registers and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices. CHAPTER IX CONFIDENTIALITY, DATA PROTECTION, FUNDING AND PENALTIES Article 102 Confidentiality 1. Unless otherwise provided for in this Regulation and without prejudice to existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: (a) personal data in accordance with Article 103; (b) commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights unless disclosure is in the public interest; (c) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits. 2. Without prejudice to paragraph 1, information exchanged on a confidential basis between competent authorities and between competent authorities and the Commission shall not be disclosed without the prior agreement of the originating authority. 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and notified bodies with regard to exchange of information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law. 4. The Commission and Member States may exchange confidential information with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. Article 103 Data protection 1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation. 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation. Article 104 Levying of fees 1. This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities set out in this Regulation, provided that the level of the fees is set in a transparent manner and on the basis of cost-recovery principles. 2. Member States shall inform the Commission and the other Member States at least three months before the structure and level of fees is to be adopted. The structure and level of fees shall be made publicly available on request. Article 105 Funding of activities related to designation and monitoring of notified bodies The costs associated with joint assessment activities shall be covered by the Commission. The Commission shall, by means of implementing acts, lay down the scale and structure of recoverable costs and other necessary implementing rules. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3). Article 106 Penalties The Member States shall lay down the rules on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate, and dissuasive. The Member States shall notify the Commission of those rules and of those measures by 25 February 2022 and shall notify it without delay of any subsequent amendment affecting them. CHAPTER X FINAL PROVISIONS Article 107 Committee procedure 1. The Commission shall be assisted by the Committee on Medical Devices established by Article 114 of Regulation (EU) 2017/745. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 or 5 thereof, as appropriate, shall apply. Article 108 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 10(4), 17(4), 24(10), 51(6) and 66(8) shall be conferred on the Commission for a period of five years from 25 May 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 10(4), 17(4), 24(10), 51(6) and 66(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 10(4), 17(4), 24(10), 51(6) and 66(8) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council. Article 109 Separate delegated acts for different delegated powers The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation. Article 110 Transitional provisions 1. From 26 May 2022, any publication of a notification in respect of a notified body in accordance with Directive 98/79/EC shall become void. 2. Certificates issued by notified bodies in accordance with Directive 98/79/EC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex VI to Directive 98/79/EC which shall become void at the latest on 27 May 2024. Certificates issued by notified bodies in accordance with Directive 98/79/EC from 25 May 2017 shall become void by 27 May 2024. 3. By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with that Directive, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply and replace the corresponding requirements in that Directive. Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all applicable requirements relating to the devices it has certified. 4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025. 5. By way of derogation from Directive 98/79/EC, devices which comply with this Regulation may be placed on the market before 26 May 2022. 6. By way of derogation from Directive 98/79/EC, conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2022. Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2022. 7. As regards devices subject to the procedures laid down in Article 48(3) and (4), paragraph 5 of this Article applies provided that the necessary appointments to the MDCG and expert panels and of EU reference laboratories have been made. 8. By way of derogation from Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to in point (f) of Article 113(3) and ending 18 months later, comply with Article 27(3) and Article 28(1) and Article 51(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC as specified in Decision 2010/227/EU. 9. Authorisations granted by the competent authorities of the Member States in accordance with Article 9(12) of Directive 98/79/EC shall keep the validity indicated in the authorisation. 10. Until the Commission has designated, pursuant to Article 24(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities. Article 111 Evaluation By 27 May 2027, the Commission shall assess the application of this Regulation and produce an evaluation report on the progress towards achievement of the objectives contained herein including an assessment of the resources required to implement this Regulation. Special attention shall be given to the traceability of devices through the storage, pursuant to Article 24, of the UDI by economic operators, health institutions and health professionals. The evaluation shall also include a review on the functioning of Article 4. Article 112 Repeal Without prejudice to Articles 110 (3) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and the obligations of manufacturers as regards the making available of documentation, under Directive 98/79/EC, that Directive is repealed with effect from 26 May 2022 with the exception of: (a) Article 11, point (c) of Article 12(1) and Article 12(2) and (3) of Directive 98/79/EC, and the obligations relating to vigilance and performance studies provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation; and (b) Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, and the obligations relating to registration of devices and economic operators, and certificate notifications provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation. As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply until 27 May 2025 to the extent necessary for the application of those paragraphs. Decision 2010/227/EU adopted in implementation of Directives 90/385/EEC, 93/42/EEC and 98/79/EC shall be repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation. References to the repealed Directive shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XV. Article 113 Entry into force and date of application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 26 May 2022. 3. By way of derogation from paragraph 2: (a) Article 27(3) and Article 51(5) shall apply from 27 November 2023; (b) Articles 31 to 46 and Article 96 shall apply from 26 November 2017. However, from that date until 26 May 2022 the obligations on notified bodies pursuant to Articles 31 to 46 shall apply only to those bodies which submit an application for designation in accordance with Article 34; (c) Article 97 shall apply from 26 May 2018; (d) Article 100 shall apply from 25 November 2020; (e) for class D devices, Article 24(4) shall apply from 26 May 2023. For class B and class C devices Article 24(4) shall apply from 26 May 2025. For class A devices Article 24(4) shall apply from 26 May 2027; (f) without prejudice to the obligations on the Commission pursuant to Article 34 of Regulation (EU) 2017/745, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1) of that Regulation, Eudamed is not fully functional on 26 May 2022, the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3) of that Regulation. The provisions referred to in the preceding sentence are: — Article 26, — Article 28, — Article 29, — the second sentence of Article 36(2), — Article 38(10), — Article 39(2), — the second subparagraph of Article 40(12), — points (d) and (e) of Article 42(7), — Article 49(2), — Article 50(1), — Articles 66 to 73, — paragraphs 1 to 13 of Article 74, — Articles 75 to 77, — Article 81(2), — Articles 82 and 83, — Article 84(5) and (7) and the third subparagraph of Article 84(8), — Article 85, — Article 88(4), (7) and (8), — Article 90(2) and (4), — the last sentence of Article 92(2), — Article 94(4), — the second sentence of the first subparagraph of Article 110(3). Until Eudamed is fully functional the corresponding provisions of Directive 98/79/EC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding performance studies, vigilance reporting, registration of devices and economic operators, and certificate notifications. (g) The procedure set out in Article 74 shall, apply from 26 May 2027 without prejudice to Article 74(14). (h) Article 110(10) shall apply from 26 May 2019. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 5 April 2017. For the European Parliament The President A. TAJANI For the Council The President I. BORG (1) Opinion of 14 February 2013 (OJ C 133, 9.5.2013, p. 52). (2) Position of the European Parliament of 2 April 2014 (not yet published in the Official Journal) and position of the Council at first reading of 7 March 2017 (not yet published in the Official Journal). (3) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1). (4) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79). (5) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1). (6) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (7) Regulation (EU) No 1025/2012 of 25 October 2012 of the European Parliament and of the Council on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). (8) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (9) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82). (10) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29). (11) Judgment of 28 July 2011 in Orifarm and Paranova, joined cases C-400/09 and C-207/10, ECLI:EU:C:2011:519. (12) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (see page 1 of this Official Journal). (13) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45). (14) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (15) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (16) Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010. p. 33). (17) OJ L 123, 12.5.2016, p. 1. (18) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (19) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17) (20) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) (21) OJ C 358, 7.12.2013, p. 10. (22) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery (OJ L 157, 9.6.2006, p. 24). (23) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). (24) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (25) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). (26) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1). ANNEXES I General safety and performance requirements II Technical documentation III Technical documentation on post-market surveillance IV EU declaration of conformity V CE marking of conformity VI Information to be submitted upon the registration of devices and economic operators in accordance with Articles 26(3) and 28, core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 25 and 26 and the UDI system VII Requirements to be met by notified bodies VIII Classification rules IX Conformity assessment based on a quality management system and on assessment of technical documentation X Conformity assessment based on type examination XI Conformity assessment based on production quality assurance XII Certificates issued by a notified body XIII Performance evaluation, performance studies and post-market performance follow-up XIV Interventional clinical performance studies and certain other performance studies XV Correlation table ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS CHAPTER I GENERAL REQUIREMENTS 1. Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. 2. The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio. 3. Manufacturers shall establish, implement, document and maintain a risk management system. Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. In carrying out risk management manufacturers shall: (a) establish and document a risk management plan for each device; (b) identify and analyse the known and foreseeable hazards associated with each device; (c) estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse; (d) eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4; (e) evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, the benefit-risk ratio and risk acceptability; and (f) based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Section 4. 4. Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, the manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority: (a) eliminate or reduce risks as far as possible through safe design and manufacture; (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users. Manufacturers shall inform users of any residual risks. 5. In eliminating or reducing risks related to use error, the manufacturer shall: (a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and (b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users). 6. The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions. 7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer. 8. All known and foreseeable risks, and any undesirable effects shall be minimised and be acceptable when weighed against the evaluated potential benefits to the patients and/or the user arising from the intended performance of the device during normal conditions of use. CHAPTER II REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE 9. Performance characteristics 9.1. Devices shall be designed and manufactured in such a way that they are suitable for the purposes referred to in point (2) of Article 2, as specified by the manufacturer, and suitable with regard to the performance they are intended to achieve, taking account of the generally acknowledged state of the art. They shall achieve the performances, as stated by the manufacturer and in particular, where applicable: (a) the analytical performance, such as, analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and quantitation, measuring range, linearity, cut-off, including determination of appropriate criteria for specimen collection and handling and control of known relevant endogenous and exogenous interference, cross-reactions; and (b) the clinical performance, such as diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, likelihood ratio, expected values in normal and affected populations. 9.2. The performance characteristics of the device shall be maintained during the lifetime of the device as indicated by the manufacturer. 9.3. Where the performance of devices depends on the use of calibrators and/or control materials, the metrological traceability of values assigned to calibrators and/or control materials shall be assured through suitable reference measurement procedures and/or suitable reference materials of a higher metrological order. Where available, metrological traceability of values assigned to calibrators and control materials shall be assured to certified reference materials or reference measurement procedures. 9.4. The characteristics and performances of the device shall be specifically checked in the event that they may be affected when the device is used for the intended use under normal conditions: (a) for devices for self-testing, performances obtained by laypersons; (b) for devices for near-patient testing, performances obtained in relevant environments (for example, patient home, emergency units, ambulances). 10. Chemical, physical and biological properties 10.1. Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in Chapter I are fulfilled. Particular attention shall be paid to the possibility of impairment of analytical performance due to physical and/or chemical incompatibility between the materials used and the specimens, analyte or marker to be detected (such as biological tissues, cells, body fluids and micro-organisms), taking account of the intended purpose of the device. 10.2. Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure. 10.3. Devices shall be designed and manufactured in such a way as to reduce to a level as low as reasonably practicable the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (1), and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2). 10.4. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the unintentional ingress of substances into the device, taking into account the device and the nature of the environment in which it is intended to be used. 11. Infection and microbial contamination 11.1. Devices and their manufacturing processes shall be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the user or, where applicable, other persons. The design shall: (a) allow easy and safe handling; (b) reduce as far as possible any microbial leakage from the device and/or microbial exposure during use; and, where necessary (c) prevent microbial contamination of the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen. 11.2. Devices labelled either as sterile or as having a specific microbial state shall be designed, manufactured and packaged to ensure that their sterile condition or microbial state is maintained under the transport and storage conditions specified by the manufacturer until that packaging is opened at the point of use, unless the packaging which maintains their sterile condition or microbial state is damaged. 11.3. Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means of appropriate, validated methods. 11.4. Devices intended to be sterilised shall be manufactured and packaged in appropriate and controlled conditions and facilities. 11.5. Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer. 11.6. The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile. 12. Devices incorporating materials of biological origin Where devices include tissues, cells and substances of animal, human or microbial origin, the selection of sources, the processing, preservation, testing and handling of tissues, cells and substances of such origin and control procedures shall be carried out so as to provide safety for user or other person. In particular, safety with regard to microbial and other transmissible agents shall be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process. This might not apply to certain devices if the activity of the microbial and other transmissible agent are integral to the intended purpose of the device or when such elimination or inactivation process would compromise the performance of the device. 13. Construction of devices and interaction with their environment 13.1. If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system, shall be safe and shall not impair the specified performances of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use. 13.2. Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible: (a) the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features; (b) risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in pressure and acceleration or radio signal interferences; (c) the risks associated with the use of the device when it comes into contact with materials, liquids, and substances, including gases, to which it is exposed during normal conditions of use; (d) the risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts; (e) the risks of accidental ingress of substances into the device; (f) the risk of incorrect identification of specimens and the risk of erroneous results due to, for example, confusing colour and/or numeric and/or character codings on specimen receptacles, removable parts and/or accessories used with devices in order to perform the test or assay as intended; (g) the risks of any foreseeable interference with other devices. 13.3. Devices shall be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention shall be paid to devices the intended use of which includes exposure to or use in association with flammable or explosive substances or substances which could cause combustion. 13.4. Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance can be done safely and effectively. 13.5. Devices that are intended to be operated together with other devices or products shall be designed and manufactured in such a way that the interoperability and compatibility are reliable and safe. 13.6. Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by users, or other person. To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use. Such procedures shall be described in the instructions for use. 13.7 The measuring, monitoring or display scale (including colour change and other visual indicators) shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used. 14. Devices with a measuring function 14.1. Devices having a primary analytical measuring function shall be designed and manufactured in such a way as to provide appropriate analytical performance in accordance with point (a) of Section 9.1 of Annex I, taking into account the intended purpose of the device. 14.2. The measurements made by devices with a measuring function shall be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC (3). 15. Protection against radiation 15.1. Devices shall be designed, manufactured and packaged in such a way that exposure of users or other persons to radiation (intended, unintended, stray or scattered) is reduced as far as possible and in a manner that is compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for diagnostic purposes. 15.2. When devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing radiation, they shall as far as possible be: (a) designed and manufactured in such a way as to ensure that the characteristics and the quantity of radiation emitted can be controlled and/or adjusted; and (b) fitted with visual displays and/or audible warnings of such emissions. 15.3. The operating instructions for devices emitting hazardous or potentially hazardous radiation shall contain detailed information as to the nature of the emitted radiation, the means of protecting the user, and on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate. Information regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure shall also be specified. 16. Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves 16.1. Devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks or impairment of performance. 16.2. For devices that incorporate software or for software that are devices in themselves, the software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation. 16.3. Software referred to in this Section that is intended to be used in combination with mobile computing platforms shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards level of light or noise). 16.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended. 17. Devices connected to or equipped with an energy source 17.1. For devices connected to or equipped with an energy source, in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks. 17.2. Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of determining the state of the power supply and an appropriate warning or indication for when the capacity of the power supply becomes critical. If necessary, such warning or indication shall be given prior to the power supply becoming critical. 17.3. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks of creating electromagnetic interference which could impair the operation of the device in question or other devices or equipment in the intended environment. 17.4. Devices shall be designed and manufactured in such a way as to provide a level of intrinsic immunity to electromagnetic interference such that is adequate to enable them to operate as intended. 17.5. Devices shall be designed and manufactured in such a way as to avoid as far as possible the risk of accidental electric shocks to the user, or other person both during normal use of the device and in the event of a single fault condition in the device, provided the device is installed and maintained as indicated by the manufacturer. 18. Protection against mechanical and thermal risks 18.1. Devices shall be designed and manufactured in such a way as to protect users and other persons against mechanical risks. 18.2. Devices shall be sufficiently stable under the foreseen operating conditions. They shall be suitable to withstand stresses inherent to the foreseen working environment, and to retain this resistance during the expected lifetime of the devices, subject to any inspection and maintenance requirements as indicated by the manufacturer. 18.3. Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means shall be incorporated. Any guards or other means included with the device to provide protection, in particular against moving parts, shall be secure and shall not interfere with access for the normal operation of the device, or restrict routine maintenance of the device as intended by the manufacturer. 18.4. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance. 18.5. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance. 18.6. Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user or other person has to handle, shall be designed and constructed in such a way as to minimise all possible risks. 18.7. Errors likely to be made when fitting or refitting certain parts which could be a source of risk shall be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings. The same information shall be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk. 18.8. Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings shall not attain potentially dangerous temperatures under normal conditions of use. 19. Protection against the risks posed by devices intended for self-testing or near-patient testing 19.1. Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to the intended user and the influence resulting from variation that can be reasonably anticipated in the intended user's technique and environment. The information and instructions provided by the manufacturer shall be easy for the intended user to understand and apply in order to correctly interpret the result provided by the device and to avoid misleading information. In the case of near-patient testing, the information and the instructions provided by the manufacturer shall make clear the level of training, qualifications and/or experience required by the user. 19.2. Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way as to: (a) ensure that the device can be used safely and accurately by the intended user at all stages of the procedure if necessary after appropriate training and/or information; and (b) reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable, the specimen, and also in the interpretation of the results. 19.3. Devices intended for self-testing and near-patient testing shall, where feasible, include a procedure by which the intended user: (a) can verify that, at the time of use, the device will perform as intended by the manufacturer; and (b) be warned if the device has failed to provide a valid result. CHAPTER III REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE 20. Label and instructions for use 20.1. General requirements regarding the information supplied by the manufacturer Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following: (a) The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams. (b) The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit. If individual full labelling of each unit is not practicable, the information shall be set out on the packaging of multiple devices. (c) Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification or bar codes. (d) Instructions for use shall be provided together with devices. However, in duly justified and exceptional cases instructions for use shall not be required or may be abbreviated if the device can be used safely and as intended by the manufacturer without any such instructions for use. (e) Where multiple devices, with the exception of devices intended for self-testing or near-patient testing, are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge. (f) When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic), except when the device is intended for near-patient testing. (g) Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer. (h) Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols, taking into account the intended users. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device. (i) In the case of devices containing a substance or a mixture which may be considered as being dangerous, taking account of the nature and quantity of its constituents and the form under which they are present, relevant hazard pictograms and labelling requirements of Regulation (EC) No 1272/2008 shall apply. Where there is insufficient space to put all the information on the device itself or on its label, the relevant hazard pictograms shall be put on the label and the other information required by Regulation (EC) No 1272/2008 shall be given in the instructions for use. (j) The provisions of Regulation (EC) No 1907/2006 on the safety data sheet shall apply, unless all relevant information, as appropriate, is already made available in the instructions for use. 20.2. Information on the label The label shall bear all of the following particulars: (a) the name or trade name of the device; (b) the details strictly necessary for a user to identify the device and, where it is not obvious for the user, the intended purpose of the device; (c) the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business; (d) if the manufacturer has its registered place of business outside the Union, the name of its authorised representative and the address of the registered place of business of the authorised representative; (e) an indication that the device is an in vitro diagnostic medical device, or if the device is a ‘device for performance study’, an indication of that fact; (f) the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate; (g) the UDI carrier as referred to in Article 24 and Part C of Annex VI; (h) an unambiguous indication of the time limit for using the device safely, without degradation of performance, expressed at least in terms of year and month and, where relevant, the day, in that order; (i) where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable; (j) where relevant, an indication of the net quantity of contents, expressed in terms of weight or volume, numerical count, or any combination of thereof, or other terms which accurately reflect the contents of the package; (k) an indication of any special storage and/or handling condition that applies; (l) where appropriate, an indication of the sterile state of the device and the sterilisation method, or a statement indicating any special microbial state or state of cleanliness; (m) warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device or to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users; (n) if the instructions for use are not provided in paper form in accordance with point (f) of Section 20.1, a reference to their accessibility (or availability), and where applicable the website address where they can be consulted; (o) where applicable, any particular operating instructions; (p) if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union; (q) if the device is intended for self-testing or near-patient testing, an indication of that fact; (r) where rapid assays are not intended for self-testing or near-patient testing, the explicit exclusion hereof; (s) where device kits include individual reagents and articles that are made available as separate devices, each of those devices shall comply with the labelling requirements contained in this Section and with the requirements of this Regulation; (t) the devices and separate components shall be identified, where applicable in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components. As far as practicable and appropriate, the information shall be set out on the device itself and/or, where appropriate, on the sales packaging; (u) the label for devices for self-testing shall bear the following particulars: (i) the type of specimen(s) required to perform the test (e.g. blood, urine or saliva); (ii) the need for additional materials for the test to function properly; (iii) contact details for further advice and assistance. The name of devices for self-testing shall not reflect an intended purpose other than that specified by the manufacturer. 20.3. Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’): The following particulars shall appear on the sterile packaging: (a) an indication permitting the sterile packaging to be recognised as such, (b) a declaration that the device is in a sterile condition, (c) the method of sterilisation, (d) the name and address of the manufacturer, (e) a description of the device, (f) the month and year of manufacture, (g) an unambiguous indication of the time limit for using the device safely, expressed at least in terms of year and month and, where relevant, the day, in that order, (h) an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use. 20.4. Information in the instructions for use 20.4.1. The instructions for use shall contain all of the following particulars: (a) the name or trade name of the device; (b) the details strictly necessary for the user to uniquely identify the device; (c) the device's intended purpose: (i) what is detected and/or measured; (ii) its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic); (iii) the specific information that is intended to be provided in the context of: — a physiological or pathological state; — congenital physical or mental impairments; — the predisposition to a medical condition or a disease; — the determination of the safety and compatibility with potential recipients; — the prediction of treatment response or reactions; — the definition or monitoring of therapeutic measures; (iv) whether it is automated or not; (v) whether it is qualitative, semi-quantitative or quantitative; (vi) the type of specimen(s) required; (vii) where applicable, the testing population; and (viii) for companion diagnostics, the International Non-proprietary Name (INN) of the associated medicinal product for which it is a companion test. (d) an indication that the device is an in vitro diagnostic medical device, or, if the device is a ‘device for performance study’, an indication of that fact; (e) the intended user, as appropriate (e.g. self-testing, near patient and laboratory professional use, healthcare professionals); (f) the test principle; (g) a description of the calibrators and controls and any limitation upon their use (e.g. suitable for a dedicated instrument only); (h) a description of the reagents and any limitation upon their use (e.g. suitable for a dedicated instrument only) and the composition of the reagent product by nature and amount or concentration of the active ingredient(s) of the reagent(s) or kit as well as a statement, where appropriate, that the device contains other ingredients which might influence the measurement; (i) a list of materials provided and a list of special materials required but not provided; (j) for devices intended for use in combination with or installed with or connected to other devices and/or general purpose equipment: — information to identify such devices or equipment, in order to obtain a validated and safe combination, including key performance characteristics, and/or — information on any known restrictions to combinations of devices and equipment. (k) an indication of any special storage (e.g. temperature, light, humidity, etc.) and/or handling conditions which apply; (l) in-use stability which may include the storage conditions, and shelf life following the first opening of the primary container, together with the storage conditions and stability of working solutions, where this is relevant; (m) if the device is supplied as sterile, an indication of its sterile state, the sterilisation method and instructions in the event of the sterile packaging being damaged before use; (n) information that allows the user to be informed of any warnings, precautions, measures to be taken and limitations of use regarding the device. That information shall cover, where appropriate: (i) warnings, precautions and/or measures to be taken in the event of malfunction of the device or its degradation as suggested by changes in its appearance that may affect performance, (ii) warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature, (iii) warnings, precautions and/or measures to be taken as regards the risks of interference posed by the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other equipment, (iv) precautions related to materials incorporated into the device that contain or consist of CMR substances, or endocrine disrupting substances or that could result in sensitisation or an allergic reaction by the patient or user, (v) if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union, (vi) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, decontamination, packaging and, where appropriate, the validated method of re-sterilisation. Information shall be provided to identify when the device should no longer be reused, such as signs of material degradation or the maximum number of allowable reuses; (o) any warnings and/or precautions related to potentially infectious material that is included in the device; (p) where relevant, requirements for special facilities, such as a clean room environment, or special training, such as on radiation safety, or particular qualifications of the intended user; (q) conditions for collection, handling, and preparation of the specimen; (r) details of any preparatory treatment or handling of the device before it is ready for use, such as sterilisation, final assembly, calibration, etc., for the device to be used as intended by the manufacturer; (s) the information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant: — details of the nature, and frequency, of preventive and regular maintenance, including cleaning and disinfection; — identification of any consumable components and how to replace them; — information on any necessary calibration to ensure that the device operates properly and safely during its intended lifetime; — methods for mitigating the risks encountered by persons involved in installing, calibrating or servicing devices. (t) where applicable, recommendations for quality control procedures; (u) the metrological traceability of values assigned to calibrators and control materials, including identification of applied reference materials and/or reference measurement procedures of higher order and information regarding maximum (self-allowed) batch to batch variation provided with relevant figures and units of measure; (v) assay procedure including calculations and interpretation of results and where relevant if any confirmatory testing shall be considered; where applicable, the instructions for use shall be accompanied by information regarding batch to batch variation provided with relevant figures and units of measure; (w) analytical performance characteristics, such as analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and measurement range, (information needed for the control of known relevant interferences, cross-reactions and limitations of the method), measuring range, linearity and information about the use of available reference measurement procedures and materials by the user; (x) clinical performance characteristics as defined in Section 9.1 of this Annex; (y) the mathematical approach upon which the calculation of the analytical result is made; (z) where relevant, clinical performance characteristics, such as threshold value, diagnostic sensitivity and diagnostic specificity, positive and negative predictive value; (aa) where relevant, reference intervals in normal and affected populations; (ab) information on interfering substances or limitations (e.g. visual evidence of hyperlipidaemia or haemolysis, age of specimen) that may affect the performance of the device; (ac) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories, and the consumables used with it, if any. This information shall cover, where appropriate: (i) infection or microbial hazards, such as consumables contaminated with potentially infectious substances of human origin; (ii) environmental hazards such as batteries or materials that emit potentially hazardous levels of radiation); (iii) physical hazards such as explosion. (ad) the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business at which he can be contacted and its location be established, together with a telephone number and/or fax number and/or website address to obtain technical assistance; (ae) date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use, with a clear indication of the introduced modifications; (af) a notice to the user that any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the competent authority of the Member State in which the user and/or the patient is established; (ag) where device kits include individual reagents and articles that may be made available as separate devices, each of these devices shall comply with the instructions for use requirements contained in this Section and with the requirements of this Regulation; (ah) for devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended. 20.4.2 In addition, the instructions for use for devices intended for self-testing shall comply with all of the following principles: (a) details of the test procedure shall be given, including any reagent preparation, specimen collection and/or preparation and information on how to run the test and interpret the results; (b) specific particulars may be omitted provided that the other information supplied by the manufacturer is sufficient to enable the user to use the device and to understand the result(s) produced by the device; (c) the device's intended purpose shall provide sufficient information to enable the user to understand the medical context and to allow the intended user to make a correct interpretation of the results; (d) the results shall be expressed and presented in a way that is readily understood by the intended user; (e) information shall be provided with advice to the user on action to be taken (in case of positive, negative or indeterminate result), on the test limitations and on the possibility of false positive or false negative result. Information shall also be provided as to any factors that can affect the test result such as age, gender, menstruation, infection, exercise, fasting, diet or medication; (f) the information provided shall include a statement clearly directing that the user should not take any decision of medical relevance without first consulting the appropriate healthcare professional, information on disease effects and prevalence, and, where available, information specific to the Member State(s) where the device is placed on the market on where a user can obtain further advice such as national helplines, websites; (g) for devices intended for self-testing used for the monitoring of a previously diagnosed existing disease or condition, the information shall specify that the patient should only adapt the treatment if he has received the appropriate training to do so. (1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). (2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 136, 29.5.2007, p. 3). (3) Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40). ANNEX II TECHNICAL DOCUMENTATION The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex. 1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES 1.1. Device description and specification (a) product or trade name and a general description of the device including its intended purpose and intended users; (b) the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, as soon as identification of this device becomes based on a UDI system, or otherwise a clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability; (c) the intended purpose of the device which may include information on: (i) what is to be detected and/or measured; (ii) its function such as screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic; (iii) the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate; (iv) whether it is automated or not; (v) whether it is qualitative, semi-quantitative or quantitative; (vi) the type of specimen(s) required; (vii) where applicable, the testing population; (viii) the intended user; (ix) in addition, for companion diagnostics, the relevant target population and the associated medicinal product(s). (d) the description of the principle of the assay method or the principles of operation of the instrument; (e) the rationale for the qualification of the product as a device; (f) the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII; (g) the description of the components and where appropriate, the description of the reactive ingredients of relevant components such as antibodies, antigens, nucleic acid primers; and where applicable: (h) the description of the specimen collection and transport materials provided with the device or descriptions of specifications recommended for use; (i) for instruments of automated assays: the description of the appropriate assay characteristics or dedicated assays; (j) for automated assays: a description of the appropriate instrumentation characteristics or dedicated instrumentation; (k) a description of any software to be used with the device; (l) a description or complete list of the various configurations/variants of the device that are intended to be made available on the market; (m) a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with the device. 1.2. Reference to previous and similar generations of the device (a) an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist; (b) an overview of identified similar devices available on the Union or international markets, where such devices exist. 2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER A complete set of (a) the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in the case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold; (b) the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold. 3. DESIGN AND MANUFACTURING INFORMATION 3.1. Design information Information to allow the design stages applied to the device to be understood shall include: (a) a description of the critical ingredients of the device such as antibodies, antigens, enzymes and nucleic acid primers provided or recommended for use with the device; (b) for instruments, a description of major subsystems, analytical technology such as operating principles and control mechanisms, dedicated computer hardware and software; (c) for instruments and software, an overview of the entire system; (d) for software, a description of the data interpretation methodology, namely the algorithm; (e) for devices intended for self-testing or near-patient testing, a description of the design aspects that make them suitable for self-testing or near-patient testing. 3.2. Manufacturing information (a) information to allow the manufacturing processes such as production, assembly, final product testing, and packaging of the finished device to be understood. More detailed information shall be provided for the audit of the quality management system or other applicable conformity assessment procedures; (b) identification of all sites, including suppliers and sub-contractors, where manufacturing activities are performed. 4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall also include: (a) the general safety and performance requirements that apply to the device and an explanation as to why others do not apply; (b) the method or methods used to demonstrate conformity with each applicable general safety and performance requirement; (c) the harmonised standards, CS or other solutions applied; (d) the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation. 5. BENFIT-RISK ANALYSIS AND RISK MANAGEMENT The documentation shall contain information on: (a) the benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and (b) the solutions adopted and the results of the risk management referred to in Section 3 of Annex I. 6. PRODUCT VERIFICATION AND VALIDATION The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements. This includes: 6.1. Information on analytical performance of the device 6.1.1. Specimen type This Section shall describe the different specimen types that can be analysed, including their stability such as storage, where applicable specimen transport conditions and, with a view to time-critical analysis methods, information on the timeframe between taking the specimen and its analysis and storage conditions such as duration, temperature limits and freeze/thaw cycles. 6.1.2. Analytical performance characteristics 6.1.2.1. Accuracy of measurement (a) Trueness of measurement This Section shall provide information on the trueness of the measurement procedure and summarise the data in sufficient detail to allow an assessment of the adequacy of the means selected to establish the trueness. Trueness measures apply to both quantitative and qualitative assays only when a certified reference material or certified reference method is available. (b) Precision of measurement This Section shall describe repeatability and reproducibility studies. 6.1.2.2. Analytical sensitivity This Section shall include information about the study design and results. It shall provide a description of specimen type and preparation including matrix, analyte levels, and how levels were established. The number of replicates tested at each concentration shall also be provided as well as a description of the calculation used to determine assay sensitivity. 6.1.2.3. Analytical specificity This Section shall describe interference and cross reactivity studies performed to determine the analytical specificity in the presence of other substances/agents in the specimen. Information shall be provided on the evaluation of potentially interfering and cross-reacting substances or agents on the assay, on the tested substance or agent type and its concentration, specimen type, analyte test concentration, and results. Interferents and cross-reacting substances or agents, which vary greatly depending on the assay type and design, could derive from exogenous or endogenous sources such as: (a) substances used for patient treatment such as medicinal products; (b) substances ingested by the patient such as alcohol, foods; (c) substances added during specimen preparation such as preservatives, stabilisers; (d) substances encountered in specific specimen types such as haemoglobin, lipids, bilirubin, proteins; (e) analytes of similar structure such as precursors, metabolites or medical conditions unrelated to the test condition including specimens negative for the assay but positive for a condition that can mimic the test condition. 6.1.2.4. Metrological traceability of calibrator and control material values 6.1.2.5. Measuring range of the assay This Section shall include information on the measuring range regardless of whether the measuring systems are linear or non-linear, including the limit of detection and describe information on how the range and detection limit were established. This information shall include a description of specimen type, number of specimens, number of replicates, and specimen preparation including information on the matrix, analyte levels and how levels were established. If applicable, a description of any high dose hook effect and the data supporting the mitigation such as dilution steps shall be added. 6.1.2.6. Definition of assay cut-off This Section shall provide a summary of analytical data with a description of the study design including methods for determining the assay cut-off, such as: (a) the population(s) studied: demographics, selection, inclusion and exclusion criteria, number of individuals included; (b) method or mode of characterisation of specimens; and (c) statistical methods such as Receiver Operator Characteristic (ROC) to generate results and if applicable, define grey-zone/equivocal zone. 6.1.3. The analytical performance report referred to in Annex XIII. 6.2. Information on clinical performance and clinical evidence. Performance Evaluation Report The documentation shall contain the performance evaluation report, which includes the reports on the scientific validity, the analytical and the clinical performance, as referred to in Annex XIII, together with an assessment of those reports. The clinical performance study documents referred to in Section 2 of Part A of Annex XIII shall be included and/or fully referenced in the technical documentation. 6.3. Stability (excluding specimen stability) This Section shall describe claimed shelf life, in use stability and shipping stability studies. 6.3.1. Claimed shelf-life This Section shall provide information on stability testing studies to support the shelf life that is claimed for the device. Testing shall be performed on at least three different lots manufactured under conditions that are essentially equivalent to routine production conditions. The three lots do not need to be consecutive. Accelerated studies or extrapolated data from real time data are acceptable for initial shelf life claims but shall be followed up with real time stability studies. Such detailed information shall include: (a) the study report including the protocol, number of lots, acceptance criteria and testing intervals; (b) where accelerated studies have been performed in anticipation of the real time studies, the method used for accelerated studies shall be described; (c) the conclusions and claimed shelf life. 6.3.2. In-use stability This Section shall provide information on in-use stability studies for one lot reflecting actual routine use of the device, regardless of whether real or simulated. This may include open vial stability and/or, for automated instruments, on board stability. In the case of automated instrumentation, if calibration stability is claimed, supporting data shall be included. Such detailed information shall include: (a) the study report (including the protocol, acceptance criteria and testing intervals); (b) the conclusions and claimed in-use stability. 6.3.3. Shipping stability This Section shall provide information on shipping stability studies for one lot of devices to evaluate the tolerance of devices to the anticipated shipping conditions. Shipping studies may be done under real and/or simulated conditions and shall include variable shipping conditions such as extreme heat and/or cold. Such information shall describe: (a) the study report (including the protocol, acceptance criteria); (b) the method used for simulated conditions; (c) the conclusion and recommended shipping conditions. 6.4. Software verification and validation The documentation shall contain evidence of the validation of the software, as it is used in the finished device. Such information shall typically include the summary results of all verification, validation and testing performed in-house and applicable in an actual user environment prior to final release. It shall also address all of the different hardware configurations and, where applicable, operating systems identified in the labelling. 6.5. Additional information required in specific cases (a) In the case of devices placed on the market in a sterile or defined microbiological condition, a description of the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with regard to packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues. (b) In the case of devices containing tissues, cells and substances of animal, human or microbial origin, information on the origin of such material and on the conditions in which it was collected. (c) In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications. (d) If the device is to be connected to other equipment in order to operate as intended, a description of the resulting combination including proof that it conforms to the general safety and performance requirements set out in Annex I when connected to any such equipment having regard to the characteristics specified by the manufacturer. ANNEX III TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 78 to 81 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex. 1. The post-market surveillance plan drawn up in accordance with Article 79. The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 78. (a) The post-market surveillance plan shall address the collection and utilisation of available information, in particular: — information concerning serious incidents, including information from PSURs, and field safety corrective actions, — records referring to non-serious incidents and data on any undesirable side-effects, — information from trend reporting, — relevant specialist or technical literature, databases and/or registers, — information, including feedbacks and complaints, provided by users, distributors and importers, and — publicly-available information about similar medical devices. (b) The post-market surveillance plan shall cover at least: — a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market; — effective and appropriate methods and processes to assess the collected data; — suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I; — effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field; — methods and protocols to manage the events subject to the trend report as provided for in Article 83, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period; — methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users; — reference to procedures to fulfil the manufacturers obligations laid down in Articles 78, 79 and 81; — systematic procedures to identify and initiate appropriate measures including corrective actions; — effective tools to trace and identify devices for which corrective actions might be necessary; and — a PMPF plan as referred to in Part B of Annex XIII, or a justification as to why a PMPF is not applicable. 2. The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80. ANNEX IV EU DECLARATION OF CONFORMITY The EU declaration of conformity shall contain the following information: 1. Name, registered trade name or registered trade mark and, if already issued, SRN referred to in Article 28 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established; 2. A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer; 3. The Basic UDI-DI as referred to in Part C of Annex VI; 4. Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3; 5. Risk class of the device in accordance with the rules set out in Annex VIII; 6. A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity; 7. References to any CS used and in relation to which conformity is declared; 8. Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued; 9. Where applicable, additional information; 10. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature. ANNEX V CE MARKING OF CONFORMITY 1. The CE marking shall consist of the initials ‘CE’ taking the following form: 2. If the CE marking is reduced or enlarged the proportions given in the above graduated drawing shall be respected. 3. The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices. ANNEX VI INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 AND THE UDI SYSTEM PART A INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 26(3) AND 28 Manufacturers or, when applicable, authorised representatives, and, when applicable, importers shall submit the information referred to in Section 1 and shall ensure that the information on their devices referred to in Section 2 is complete, correct and updated by the relevant party. 1. Information relating to the economic operator 1.1. type of economic operator (manufacturer, authorised representative, or importer), 1.2. name, address and contact details of the economic operator, 1.3. where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person, 1.4. name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15, 2. Information relating to the device 2.1. Basic UDI-DI, 2.2. type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body and the link to the information that appears on the certificate and was entered by the notified body in the electronic system on notified bodies and certificates, 2.3. Member State in which the device shall or has been placed on the market in the Union, 2.4. in the case of class B, class C or class D devices: Member States where the device is or is to be made available, 2.5. presence of tissues, cells, or, their derivatives, of human origin (y/n), 2.6. presence of tissues, cells or their derivatives of animal origin as referred to in Regulation (EU) No 722/2012(y/n), 2.7. presence of cells or substances of microbial origin (y/n), 2.8. risk class of the device, 2.9. where applicable, the single identification number of the performance study, 2.10. in the case of devices designed and manufactured by another legal or natural person as referred in Article 10(14), the name, address and contact details of that legal or natural person, 2.11. in the case of class C or D devices, the summary of safety and performance, 2.12. status of the device (on the market, no longer placed on the market, recalled, field safety corrective Action initiated), 2.13. indication as to whether the device is a ‘new’ device. A device shall be considered to be ‘new’ if: (a) there has been no such device continuously available on the Union market during the previous three years for the relevant analyte or other parameter; (b) the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Union market during the previous three years. 2.14. indication as to whether the device is intended for self-testing or near-patient testing. PART B CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 25 AND 26 The manufacturer shall provide to the UDI database the UDI-DI and the following information relating to the manufacturer and the device: 1. quantity per package configuration, 2. the Basic UDI-DI as referred to in Article 24(6) and any additional UDI-DIs, 3. the manner in which production of the device is controlled (expiry date or manufacturing date, lot number, serial number), 4. if applicable, the ‘unit of use’ UDI-DI (where a UDI is not labelled on the device at the level of its ‘unit of use’, a ‘unit of use’ UDI-DI shall be assigned so as to associate the use of a device with a patient), 5. name and address of the manufacturer, as indicated on the label, 6. the SRN issued in accordance with Article 28(2), 7. if applicable, name and address of the authorised representative (as indicated on the label), 8. the medical device nomenclature code as provided for in Article 23, 9. risk class of the device, 10. if applicable, name or trade name, 11. if applicable, device model, reference, or catalogue number, 12. additional product description (optional), 13. if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use), 14. if applicable, additional trade names of the device, 15. labelled as a single use device (y/n), 16. if applicable, the maximum number of reuses, 17. device labelled sterile (y/n), 18. need for sterilisation before use (y/n), 19. URL for additional information, such as electronic instructions for use (optional), 20. if applicable, critical warnings or contra-indications, 21. status of the device (on the market, no longer placed on the market, recalled, field safety action initiated). PART C THE UDI SYSTEM 1. Definitions Automatic identification and data capture (‘AIDC’) AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart cards, biometrics and RFID. Basic UDI-DI The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity. Unit of Use DI The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together. Configurable device A configurable device is a device that consists of several components which can be assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves. Configuration Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose. The combination of items may be modified, adjusted or customised to meet specific needs. UDI-DI The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database. Human Readable Interpretation (HRI) HRI is a legible interpretation of the data characters encoded in the UDI carrier. Packaging levels Packaging levels means the various levels of device packaging that contain a fixed quantity of devices, such as a carton or case. Production Identifier (UDI-PI) The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PI(s) include serial number, lot number, software identification and manufacturing or expiry date or both types of date. Radio Frequency Identification (‘RFID’) RFID is a technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification. Shipping containers A shipping container is a container in relation to which traceability is controlled by a process specific to logistics systems. Unique Device Identifier (‘UDI’) The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific device on the market. The UDI is comprised of the UDI-DI and the UDI-PI. The word ‘Unique’ does not imply serialisation of individual production units. UDI carrier The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, its HRI. UDI carriers include, inter alia, ID/linear bar code, 2D/Matrix bar code, RFID. 2. General requirements 2.1. The affixing of the UDI is an additional requirement — it does not replace any other marking or labelling requirements laid down in Annex I to this Regulation. 2.2. The manufacturer shall assign and maintain unique UDIs for its devices. 2.3. Only the manufacturer may place the UDI on the device or its packaging. 2.4. Only coding standards provided by issuing entities designated by the Commission pursuant to Article 24(2) may be used. 3. The UDI 3.1. A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI. 3.2. Shipping containers shall be exempted from the requirement in Section 3.1. By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements. 3.3. The UDI shall contain two parts: a UDI-DI and a UDI-PI. 3.4. The UDI-DI shall be unique at each level of device packaging. 3.5. If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI. 3.6. Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI. 3.7. Kits shall be assigned and bear their own UDI. 3.8. The manufacturer shall assign the UDI to a device following the relevant coding standard. 3.9. A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, any change of one of the following UDI database data elements shall require a new UDI-DI: (a) Name or trade name, (b) device version or model, (c) labelled as single use, (d) packaged sterile, (e) need for sterilization before use, (f) quantity of devices provided in a package, (g) critical warnings or contra-indications. 3.10. Manufacturers that repackage or relabel devices with their own label shall retain a record of the original device manufacturer's UDI. 4. UDI carrier 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label and on all higher levels of device packaging. Higher levels do not include shipping containers. 4.2. In the event of there being significant space constraints on the unit of use packaging the UDI carrier may be placed on the next higher packaging level. 4.3. For single use class A and class B devices packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging e.g. a carton containing several packages. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging. 4.4. For devices exclusively intended for retail point of sale, the UDI-PIs in AIDC shall not be required to appear on the point of sale packaging. 4.5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be readily identifiable. 4.6. If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable. 4.7. If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label. For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC. 4.8. The HRI format shall follow the rules of the UDI code-issuing entity. 4.9. If the manufacturer is using RFID technology, a linear or 2D bar code in line with the standard provided by the issuing entities shall also be provided on the label. 4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. 4.11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device. 4.12. If the UDI carrier is readily readable or scannable through the device's packaging, the placing of the UDI carrier on the packaging shall not be required. 4.13. In the case of single finished devices made up of multiple parts that must be assembled before first use, it shall be sufficient to place the UDI carrier on only one part of each device. 4.14. The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal operation or storage. 4.15. Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to operate or other data. 5. General principles of the UDI database 5.1. The UDI database shall support the use of all core UDI database data elements referred to in Part B of this Annex. 5.2. Manufacturers shall be responsible for the initial submission and updates of the identifying information and other device data elements in the UDI database. 5.3. Appropriate methods/procedures for validation of the data provided shall be implemented. 5.4. Manufacturers shall periodically verify the correctness of all of the data relevant to devices they have placed on the market, except for devices that are no longer available on the market. 5.5. The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the device is in conformity with this Regulation. 5.6. The database shall allow for the linking of all the packaging levels of the device. 5.7. The data for new UDI-DIs shall be available at the time the device is placed on the market. 5.8. Manufacturers shall update the relevant UDI database record within 30 days of a change being made to an element, which does not require a new UDI-DI. 5.9. Internationally accepted standards for data submission and updates shall, wherever possible, be used by the UDI database. 5.10. The user interface of the UDI database shall be available in all official languages of the Union. The use of free-text fields shall, however, be minimised in order to reduce translations. 5.11. Data relating to devices that are no longer available on the market shall be retained in the UDI database. 6. Rules for specific device types 6.1. Reusable devices that are part of kits and that require cleaning, disinfection, sterilisation or refurbishing between uses 6.1.1. The UDI of such devices shall be placed on the device and shall be readable after each procedure to make the device ready for the next use; 6.1.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer. 6.2. Device software 6.2.1. UDI assignment Criteria The UDI shall be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement. The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI. 6.2.2. A new UDI-DI shall be required whenever there is a modification that changes: (a) the original performance, (b) the safety or the intended use of the software. (c) interpretation of data. Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability. 6.2.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI: Minor software revisions are generally associated with bug fixes, usability enhancements that are not for safety purposes, security patches or operating efficiency. Minor software revisions shall be identified by a manufacturer-specific form of identification. 6.2.4. UDI placement criteria for software (a) where the software is delivered on a physical medium, for example via a CD or DVD, each packaging level shall bear the human readable and AIDC representation of the complete UDI. The UDI that is applied to the physical medium containing the software and its packaging shall be identical to the UDI assigned to the system level software; (b) the UDI shall be provided on a readily accessible screen for the user in an easily-readable plain-text format such as an ‘about’ file, or included on the start-up screen; (c) software lacking a user interface such as middleware for image conversion, shall be capable of transmitting the UDI through an application programming interface (API); (d) only the human readable portion of the UDI shall be required in electronic displays of the software. The marking of UDI using AIDC shall not be required in the electronic displays such as ‘about’ menu, splash screen, etc.; (e) the human readable format of the UDI for the software shall include the application identifiers (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI and determining which standard is being used to create the UDI. ANNEX VII REQUIREMENTS TO BE MET BY NOTIFIED BODIES 1. ORGANISATIONAL AND GENERAL REQUIREMENTS 1.1. Legal status and organisational structure 1.1.1. Each notified body shall be established under the national law of a Member State, or under the law of a third country with which the Union has concluded an agreement in this respect. Its legal personality and status shall be fully documented. Such documentation shall include information about ownership and the legal or natural persons exercising control over the notified body. 1.1.2. If the notified body is a legal entity that is part of a larger organisation, the activities of that organisation as well as its organisational structure and governance, and the relationship with the notified body shall be clearly documented. In such cases, the requirements of Section 1.2 are applicable to both the notified body and the organisation to which it belongs. 1.1.3. If a notified body wholly or partly owns legal entities established in a Member State or in a third country or is owned by another legal entity, the activities and responsibilities of those entities, as well as their legal and operational relationships with the notified body, shall be clearly defined and documented. Personnel of those entities performing conformity assessment activities under this Regulation shall be subject to the applicable requirements of this Regulation. 1.1.4. The organisational structure, allocation of responsibilities, reporting lines and operation of the notified body shall be such that they ensure that there is confidence in the performance by the notified body and in the results of the conformity assessment activities it conducts. 1.1.5. The notified body shall clearly document its organisational structure and the functions, responsibilities and authority of its top-level management and of other personnel who may have an influence upon the performance by the notified body upon the results of its conformity assessment activities. 1.1.6. The notified body shall identify the persons in top-level management that have overall authority and responsibility for each of the following: (a) provision of adequate resources for conformity assessment activities; (b) development of procedures and policies for the operation of the notified body; (c) supervision of implementation of the procedures, policies and quality management systems of the notified body; (d) supervision of the notified body's finances; (e) activities and decisions taken by the notified body, including contractual agreements; (f) delegation of authority to personnel and/or committees, where necessary, for the performance of defined activities; (g) interaction with the authority responsible for notified bodies and the obligations regarding communications with other competent authorities, the Commission and other notified bodies. 1.2. Independence and impartiality 1.2.1. The notified body shall be a third-party body that is independent of the manufacturer of the device in relation to which it performs conformity assessment activities. The notified body shall also be independent of any other economic operator having an interest in the device as well as of any competitors of the manufacturer. This does not preclude the notified body from carrying out conformity assessment activities for competing manufacturers. 1.2.2. The notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities. The notified body shall document and implement a structure and procedures for safeguarding impartiality and for promoting and applying the principles of impartiality throughout its organisation, personnel and assessment activities. Such procedures shall provide for the identification, investigation and resolution of any case in which a conflict of interest may arise including involvement in consultancy services in the field of devices prior to taking up employment with the notified body. The investigation, outcome and its resolution shall be documented. 1.2.3. The notified body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not: (a) be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which they assess, nor the authorised representative of any of those parties. Such restriction shall not preclude the purchase and use of assessed devices that are necessary for the operations of the notified body and the conduct of the conformity assessment, or the use of such devices for personal purposes; (b) be involved in the design, manufacture or construction, marketing, installation and use, or maintenance of the devices for which they are designated, nor represent the parties engaged in those activities; (c) engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are designated; (d) offer or provide any service which may jeopardise the confidence in their independence, impartiality or objectivity. In particular, they shall not offer or provide consultancy services to the manufacturer, its authorised representative, a supplier or a commercial competitor as regards the design, construction, marketing or maintenance of the devices or processes under assessment; and (e) be linked to any organisation which itself provides consultancy services as referred to in the point (d). Such restriction shall not preclude general training activities that are not client specific and that relate to regulation of devices s or to related standards. 1.2.4. Involvement in consultancy services in the field of devices prior to taking up employment with a notified body shall be fully documented at the time of employment, and potential conflicts of interests shall be monitored and resolved in accordance with this Annex. Personnel who were formerly employed by a specific client, or provided consultancy services in the field of devices to that specific client prior to taking up employment with a notified body, shall not be assigned for conformity assessment activities for that specific client or companies belonging to the same group for a period of three years. 1.2.5. The impartiality of notified bodies, of their top-level management and of the assessment personnel shall be guaranteed. The level of the remuneration of the top-level management and assessment personnel of a notified body and subcontractors involved in assessment activities shall not depend on the results of the assessments. Notified bodies shall make publicly available the declarations of interest of their top-level management. 1.2.6. If a notified body is owned by a public entity or institution, independence and absence of any conflict of interests shall be ensured and documented between, on the one hand, the authority responsible for notified bodies and/or the competent authority and, on the other hand, the notified body. 1.2.7. The notified body shall ensure and document that the activities of its subsidiaries or subcontractors or of any associated body, including the activities of its owners do not affect its independence, impartiality or the objectivity of its conformity assessment activities. 1.2.8. The notified body shall operate in accordance with a set of consistent, fair and reasonable terms and conditions, taking into account the interests of small and medium-sized enterprises as defined in Recommendation 2003/361/EC in relation to fees. 1.2.9. The requirements laid down in this Section shall in no way preclude exchanges of technical information and regulatory guidance between a notified body and a manufacturer applying for conformity assessment. 1.3. Confidentiality 1.3.1. The notified body shall have documented procedures in place ensuring that its personnel, committees, subsidiaries, subcontractors, and any associated body or personnel of external bodies respect the confidentiality of the information which comes into its possession during the performance of the conformity assessment activities, except when disclosure is required by law. 1.3.2. The personnel of a notified body shall observe professional secrecy in carrying out their tasks under this Regulation or any provision of national law giving effect to it, except in relation to the authorities responsible for notified bodies, competent authorities for devices in the Member States or the Commission. Proprietary rights shall be protected. The notified body shall have documented procedures in place in respect of the requirement of this Section. 1.4. Liability 1.4.1. The notified body shall take out appropriate liability insurance for its conformity assessment activities, unless liability is assumed by the Member State in question in accordance with national law or that Member State is directly responsible for their conformity assessment. 1.4.2. The scope and overall financial value of the liability insurance shall correspond to the level and geographic scope of activities of the notified body and be commensurate with the risk profile of the devices certified by the notified body. The liability insurance shall cover cases where the notified body may be obliged to withdraw, restrict or suspend certificates. 1.5. Financial requirements The notified body shall have at its disposal the financial resources required to conduct its conformity assessment activities within its scope of designation and related business operations. It shall document and provide evidence of its financial capacity and its long-term economic viability, taking into account, where relevant, any specific circumstances during an initial start-up phase. 1.6. Participation in coordination activities 1.6.1. The notified body shall participate in, or ensure that its assessment personnel is informed of any relevant standardisation activities and in the activities of the notified body coordination group referred to in Article 49 of Regulation (EU) 2017/745 and that its assessment and decision-making personnel are informed of all relevant legislation, guidance and best practice documents adopted in the framework of this Regulation. 1.6.2. The notified body shall take into consideration guidance and best practice documents. 2. QUALITY MANAGEMENT REQUIREMENTS 2.1. The notified body shall establish, document, implement, maintain and operate a quality management system that is appropriate to the nature, area and scale of its conformity assessment activities and is capable of supporting and demonstrating the consistent fulfilment of the requirements of this Regulation. 2.2. The quality management system of the notified body shall address at least the following: (a) management system structure and documentation, including policies and objectives for its activities; (b) policies for assignment of activities and responsibilities to personnel; (c) assessment and decision-making processes in accordance with the tasks, responsibilities and role of the notified body's personnel and top-level management; (d) the planning, conduct, evaluation and, if necessary, adaptation of its conformity assessment procedures; (e) control of documents; (f) control of records; (g) management reviews; (h) internal audits; (i) corrective and preventive actions; (j) complaints and appeals; (k) continuous training. Where documents are used in various languages, the notified body shall ensure and control that they have the same content. 2.3. The top-level management of the notified body shall ensure that the quality management system is fully understood, implemented and maintained throughout the notified body organisation including subsidiaries and subcontractors involved in conformity assessment activities pursuant to this Regulation. 2.4. The notified body shall require all personnel to formally commit themselves by a signature or equivalent to comply with the procedures defined by the notified body. That commitment shall cover aspects relating to confidentiality and to independence from commercial and other interests, and any existing or prior association with clients. The personnel shall be required to complete written statements indicating their compliance with confidentiality, independence and impartiality principles. 3. RESOURCE REQUIREMENTS 3.1. General 3.1.1. Notified bodies shall be capable of carrying out all the tasks falling to them under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility. In particular, notified bodies shall have the necessary personnel and possess or have access to all equipment, facilities and competence needed to perform properly the technical, scientific and administrative tasks entailed in the conformity assessment activities in relation to which they have been designated. Such requirement presupposes at all times and for each conformity assessment procedure and each type of devices in relation to which they have been designated, that the notified body has permanent availability of sufficient administrative, technical and scientific personnel who possess experience and knowledge relating to the relevant devices and the corresponding technologies. Such personnel shall be in sufficient numbers to ensure that the notified body in question can perform the conformity assessment tasks, including the assessment of the medical functionality, performance evaluations and the performance and safety of devices, for which it has been designated, having regard to the requirements of this Regulation, in particular those set out in Annex I. A notified body's cumulative competences shall be such as to enable it to assess the types of devices for which it is designated. The notified body shall have sufficient internal competence to critically evaluate assessments conducted by external expertise. Tasks which a notified body is precluded from subcontracting are set out in Section 4.1. Personnel involved in the management of the operation of a notified body's conformity assessment activities for devices shall have appropriate knowledge to set up and operate a system for the selection of assessment and verification staff, for verification of their competence, for authorisation and allocation of their tasks, for organisation of their initial and ongoing training, and for their assignment of their duties and monitoring of those staff, in order to ensure that personnel who carry out and perform assessment and verification operations are competent to fulfil the tasks required of them. The notified body shall identify at least one individual within its top-level management as having overall responsibility for all conformity assessment activities in relation to devices. 3.1.2. The notified body shall ensure that personnel involved in conformity assessment activities maintain their qualification and expertise by implementing a system for exchange of experience and a continuous training and education programme. 3.1.3. The notified body shall clearly document the extent and limits of duties and responsibilities and the level of authorisation of to the personnel, including any subcontractors and external experts involved in conformity assessment activities and inform those personnel accordingly. 3.2. Qualification criteria in relation to personnel 3.2.1. The notified body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities, including as regards knowledge, experience and other competence required, and the required initial and ongoing training. The qualification criteria shall address the various functions within the conformity assessment process, such as auditing, product evaluation or testing, technical documentation review, decision-making, and batch release, as well as the devices, technologies and areas, such as biocompatibility, sterilisation, self and near patient-testing, companion diagnostics and performance evaluation, covered by the scope of designation. 3.2.2. The qualification criteria referred to in Section 3.2.1 shall refer to the scope of the notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 38(3), providing a sufficient level of detail for the required qualification within the subdivisions of the scope description. Specific qualification criteria shall be defined at least for the assessment of: — biological safety, — performance evaluation, — devices for self and near patient testing, — companion diagnostics, — functional safety, — software, — packaging, and — the different types of sterilisation processes. 3.2.3. The personnel responsible for establishing qualification criteria and for authorising other personnel to perform specific conformity assessment activities shall be employed by the notified body itself and shall not be external experts or subcontracted. They shall have proven knowledge and experience in all of the following: — Union devices legislation and relevant guidance documents; — the conformity assessment procedures provided for in this Regulation; — a broad base of knowledge of device technologies and the design and manufacture of devices; — the notified body's quality management system, related procedures and the required qualification criteria; — training relevant to personnel involved in conformity assessment activities in relation to devices; — adequate experience in conformity assessments under this Regulation or previously applicable law within a notified body. 3.2.4. The notified body shall have permanent availability of personnel with relevant clinical expertise and where possible such personnel shall be employed by the notified body itself. Such personnel shall be integrated throughout the notified body's assessment and decision-making process in order to: — identify when specialist input is required for the assessment of the performance evaluation conducted by the manufacturer and identify appropriately qualified experts; — appropriately train external clinical experts in the relevant requirements of this Regulation, CS, guidance and harmonised standards and ensure that the external clinical experts are fully aware of the context and implications of their assessment and the advice they provide; — be able to review and scientifically challenge the clinical data contained within the performance evaluation, and any associated performance study, and appropriately guide external clinical experts in the assessment of the performance evaluation presented by the manufacturer; — be able to scientifically evaluate and, if necessary, challenge the performance evaluation presented, and the results of the external clinical experts' assessment of the manufacturer's performance evaluation; — be able to ascertain the comparability and consistency of the assessments of performance evaluation conducted by clinical experts; — be able to make an assessment of the manufacturer's performance evaluation and a clinical judgement of the opinion provided by any external expert and make a recommendation to the notified body's decision maker; and — be able to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out. 3.2.5. The personnel responsible for carrying out product-related reviews, (product reviewers), such as technical documentation reviews or type examination, including aspects such as performance evaluation, biological safety, sterilisation and software validation, shall have all the following proven qualifications: — successful completion of a university or a technical college degree or an equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences; — four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing or use of devices or technology to be assessed or related to the scientific aspects to be assessed; — knowledge of device legislation, including the general safety and performance requirements set out in Annex I; — appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents; — appropriate knowledge and experience of risk management and related device standards and guidance documents; — appropriate knowledge and experience of performance evaluation; — appropriate knowledge of the devices which they are assessing; — appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those assessments; — the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out. 3.2.6. The personnel responsible for carrying out audits of the manufacturer's quality management system (site auditors) shall have all of the following proven qualifications: — successful completion of a university or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences; — four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the area of quality management; — appropriate knowledge of devices legislation as well as related harmonised standards, CS and guidance documents; — appropriate knowledge and experience of risk management and related device standards and guidance documents; — appropriate knowledge of quality management systems and related l devices standards and guidance documents; — appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those audits; — training in auditing techniques enabling them to challenge quality management systems; — the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out. 3.2.7. The personnel with overall responsibility for final reviews and decision-making on certification shall be employed by the notified body itself and shall not be external experts or be subcontracted. Those personnel, as a group, shall have proven knowledge and comprehensive experience of all of the following: — devices legislation and relevant guidance documents; — device conformity assessments relevant to this Regulation; — the types of qualifications, experience and expertise relevant to device conformity assessment; — a broad base of knowledge of device technologies, including sufficient experience of the conformity assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices; — the notified body's quality system, related procedures and the required qualifications for personnel involved; — the ability to draw up records and reports demonstrating that the conformity assessment activities have been appropriately carried out. 3.3. Documentation of qualification, training and authorisation of personnel 3.3.1. The notified body shall have a procedure in place to fully document the qualification of each member of personnel involved in conformity assessment activities and the satisfaction of the qualification criteria referred to in Section 3.2. Where, in exceptional circumstances, the fulfilment of the qualification criteria set out in Section 3.2 cannot be fully demonstrated, the notified body shall justify to the authority responsible for notified bodies the authorisation of those members of personnel to carry out specific conformity assessment activities. 3.3.2. For all of its personnel referred to in Sections 3.2.3 to 3.2.7, the notified body shall establish and maintain up to date: — a matrix detailing the authorisations and responsibilities of the personnel in respect of conformity assessment activities; — records attesting to the required knowledge and experience for the conformity assessment activity for which they are authorised. The records shall contain a rationale for defining the scope of the responsibilities for each of the assessment personnel and records of the conformity assessment activities carried out by each of them. 3.4. Subcontractors and external experts 3.4.1. Notified bodies may, without prejudice to Section 3.2, subcontract certain clearly defined component parts of a conformity assessment activity. The subcontracting of the auditing of quality management systems or of product-related reviews as a whole shall not be permitted, nevertheless parts of those activities may be conducted by subcontractors and external auditors and experts working on behalf of the notified body. The notified body in question shall retain full responsibility for being able to produce appropriate evidence of the competence of subcontractors and experts to fulfil their specific tasks, for making a decision based on a subcontractor's assessment and for the work conducted by subcontractors and experts on its behalf. The following activities may not be subcontracted by notified bodies: — review of the qualifications and monitoring of the performance of external experts; — auditing and certification activities where the subcontracting in question is to auditing or certification organisations; — allocation of work to external experts for specific conformity assessment activities; — final review and decision-making functions. 3.4.2. Where a notified body subcontracts certain conformity assessment activities either to an organisation or an individual, it shall have a policy describing the conditions under which subcontracting may take place, and shall ensure that: — the subcontractor meets the relevant requirements of this Annex; — subcontractors and external experts do not further subcontract work to organisations or personnel; — the natural or legal person that applied for conformity assessment has been informed of the requirements referred to in the first and second indent. Any subcontracting or consultation of external personnel shall be properly documented, shall not involve any intermediaries, and shall be subject to a written agreement covering, among other things, confidentiality and conflicts of interest. The notified body in question shall take full responsibility for the tasks performed by subcontractors. 3.4.3. Where subcontractors or external experts are used in the context of a conformity assessment, in particular regarding novel devices or technologies, the notified body in question shall have adequate internal competence in each product area for which it is designated that is adequate for the purpose of leading the overall conformity assessment, verifying the appropriateness and validity of expert opinions and making decisions on certification. 3.5. Monitoring of competences, training and exchange of experience 3.5.1. The notified body shall establish procedures for the initial evaluation and on-going monitoring of the competence, conformity assessment activities and performance of all internal and external personnel and subcontractors, involved in conformity assessment activities. 3.5.2. Notified bodies shall review at regular intervals, the competence of their personnel, identify training needs and draw up a training plan to maintain the required level of qualification and knowledge of individual personnel. That review shall as a minimum, verify that personnel: — are aware of the Union and national law in force on devices, relevant harmonised standards, CS, guidance documents and the results of the coordination activities referred to in Section 1.6; — take part in the internal exchange of experience and the continuous training and education programme referred to in Section 3.1.2. 4. PROCESS REQUIREMENTS 4.1. General The notified body shall have in place documented processes and sufficiently detailed procedures for the conduct of each conformity assessment activity for which it is designated, comprising the individual steps from pre-application activities up to decision making and surveillance and taking into account, when necessary, the respective specificities of the devices. The requirements laid down in Sections 4.3, 4.4, 4.7 and 4.8 shall be fulfilled as part of the internal activities of notified bodies and shall not be subcontracted. 4.2. Notified body quotations and pre-application activities The notified body shall (a) publish a publicly available description of the application procedure by which manufacturers can obtain certification from it. That description shall include which languages are acceptable for submission of documentation and for any related correspondence; (b) have documented procedures relating to, and documented details about, fees charged for specific conformity assessment activities and any other financial conditions relating to notified bodies' assessment activities for devices;, (c) have documented procedures in relation to advertising of its conformity assessment services. Those procedures shall ensure that advertising or promotional activities in no way imply or are capable of leading to an inference that their conformity assessment will offer manufacturers earlier market access or be quicker, easier or less stringent than that of other notified bodies; (d) have documented procedures requiring the review of pre-application information including the preliminary verification that the product is covered by this Regulation and its classification prior to issuing any quotation to the manufacturer relating to a specific conformity assessment; (e) ensure that all contracts relating to the conformity assessment activities covered by this Regulation are concluded directly between the manufacturer and the notified body and not with any other organisation. 4.3. Application review and contract The notified body shall require a formal application signed by a manufacturer or an authorised representative containing all of the information and the manufacturer's declarations required by the relevant conformity assessment as referred to in Annexes IX to XI. The contract between a notified body and a manufacturer shall take the form of a written agreement signed by both parties. It shall be kept by the notified body. This contract shall have clear terms and conditions and contain obligations that enable the notified body to act as required under this Regulation, including an obligation on the manufacturer to inform the notified body of vigilance reports, the right of the notified body to suspend, restrict or withdraw certificates issued and the duty of the notified body to fulfil its information obligations. The notified body shall have documented procedures to review applications, addressing: (a) the completeness of those applications with respect to the requirements of the relevant conformity assessment procedure, as referred to in the corresponding Annex, under which approval has been sought, (b) the verification of the qualification of products covered by those applications as devices and their respective classifications, (c) whether the conformity assessment procedures chosen by the applicant are applicable to the device in question under this Regulation, (d) the ability of the notified body to assess the application based on its designation, and (e) the availability of sufficient and appropriate resources. The outcome of each review of an application shall be documented. Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 52 and shall be accessible to other notified bodies. 4.4. Allocation of resources The notified body shall have documented procedures to ensure that all conformity assessment activities are conducted by appropriately authorised and qualified personnel who are sufficiently experienced in the evaluation of the devices, systems and processes and related documentation that are subject to conformity assessment. For each application, the notified body shall determine the resources needed and identify one individual responsible for ensuring that the assessment of that application is conducted in accordance with the relevant procedures and for ensuring that the appropriate resources including personnel are utilised for each of the tasks of the assessment. The allocation of tasks required to be carried out as part of the conformity assessment and any changes subsequently made to this allocation shall be documented. 4.5. Conformity assessment activities 4.5.1. General The notified body and its personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical and scientific competence in the specific fields. The notified body shall have expertise, facilities and documented procedures that are sufficient to effectively conduct the conformity assessment activities for which the notified body in question is designated, taking account of the relevant requirements set out in Annexes IX to XI and in particular the following requirements: — to appropriately plan the conduct of each individual project, — to ensure that the composition of the assessment teams is such that there is sufficient experience in relation to the technology concerned, and that there is continuous objectivity and independence, and to provide for rotation of the members of the assessment team at appropriate intervals, — to specify the rationale for fixing time limits for completion of conformity assessment activities, — to assess the manufacturer's technical documentation and the solutions adopted to meet the requirements laid down in Annex I, — to review the manufacturer's procedures and documentation relating to performance evaluation, — to address the interface between the manufacturer's risk management process and its appraisal and analysis of the performance evaluation and to evaluate their relevance for the demonstration of conformity with the relevant requirements in Annex I, — to carry out the ‘specific procedures’ referred to in Section 5 of Annex IX, — in the case of class B or C devices, to assess the technical documentation of devices selected on a representative basis, — to plan and periodically carry out appropriate surveillance audits and assessments, to carry out or request certain tests to verify the proper functioning of the quality management system and to perform unannounced on site audits, — relating to the sampling of devices verify that the manufactured device is in conformity with the technical documentation; such requirements shall define the relevant sampling criteria and testing procedure prior to sampling, — to evaluate and verify a manufacturer's compliance with relevant Annexes. The notified body shall, where relevant, take into consideration available CS, guidance and best practice documents and harmonised standards, even if the manufacturer does not claim to be in compliance. 4.5.2. Quality management system auditing (a) As part of the assessment of the quality management system a, a notified body shall prior to an audit and in accordance with its documented procedures: — assess the documentation submitted in accordance with the relevant conformity assessment Annex, and draw up an audit programme which clearly identifies the number and sequence of activities required to demonstrate complete coverage of a manufacturer's quality management system and to determine whether it meets the requirements of this Regulation, — identify links between and allocation of responsibilities among, the various manufacturing sites, and identify relevant suppliers and/or subcontractors of the manufacturer, and consider the need to specifically audit any of those suppliers or subcontractors or both, — clearly define, for each audit identified in the audit programme, the objectives, criteria and scope of the audit, and draw up an audit plan that adequately addresses and takes account of the specific requirements for the devices, technologies and processes involved, — draw up and keep up to date, for class B and class C devices, a sampling plan for the assessment of technical documentation as referred to in Annexes II and III covering the range of such devices covered by the manufacturer's application. That plan shall ensure that all devices covered by the certificate are sampled over the period of validity of the certificate, — select and assign appropriately qualified and authorised personnel for conducting the individual audits. The respective roles, responsibilities and authorities of the team members shall be clearly defined and documented. (b) Based on the audit programme it has drawn up, the notified body shall, in accordance with its documented procedures: — audit the manufacturer's quality management system in order to verify that the quality management system ensures that the devices covered conform to the relevant provisions of this Regulation which apply to devices at every stage, from design through final quality control to ongoing surveillance, and shall determine whether the requirements of this Regulation are met, — based on relevant technical documentation, and in order to determine whether the manufacturer meets the requirements referred to in the relevant conformity assessment Annex, review and audit the manufacturer's processes and subsystems,– in particular for: — design and development, — production and process controls, — product documentation, — purchasing controls including verification of purchased devices, — corrective and preventive actions including for post-market surveillance, and — PMPF, — and review and audit requirements and provisions adopted by the manufacturer, including those in relation to fulfilling the general safety and performance requirements set out in Annex I, — the documentation shall be sampled in such as a manner as to reflect the risks associated with the intended use of the device, the complexity of the manufacturing technologies, the range and classes of devices produced and any available post-market surveillance information, — if not already covered by the audit programme, audit the control of processes on the premises of the manufacturer's suppliers, when the conformity of finished devices is significantly influenced by the activity of suppliers and, in particular when the manufacturer cannot demonstrate sufficient control over its suppliers, — conduct assessments of the technical documentation based on its sampling plan and taking account of Section 4.5.4. for performance evaluation, — the notified body shall ensure that audit findings are appropriately and consistently classified in accordance with the requirements of this Regulation and with relevant standards, or with best practice documents developed or adopted by the MDCG. 4.5.3. Product verification Assessment of the technical documentation For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX, notified bodies shall have sufficient expertise, facilities and documented procedures for: — the allocation of appropriately qualified and authorised personnel for the examination of individual aspects, such as use of the device, biocompatibility, performance evaluation, risk management and sterilisation, and — the assessment of conformity of the design with this Regulation, and taking account of Sections 4.5.4. and 4.5.5. This assessment shall include the examination of the implementation by manufacturers of incoming, in-process and final checks and the results thereof. If further tests or other evidence is required for the assessment of conformity with the requirements of this Regulation, the notified body in question shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests. Type-examinations The notified body shall have documented procedures, sufficient expertise and facilities for the type-examination of devices in accordance with Annex X including the capacity to: — examine and assess the technical documentation, taking account of Sections 4.5.4. and 4.5.5, and verify that the type has been manufactured in conformity with that documentation; — establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility; — document its rationale for the selection of those parameters; — carry out the appropriate examinations and tests in order to verify that the solutions adopted by the manufacturer meet the general safety and performance requirements set out in Annex I. Such examinations and tests shall include all tests necessary to verify that the manufacturer has in fact applied the relevant standards it has opted to use; — agree with the applicant as to where the necessary tests will be performed if they are not to be carried out directly by the notified body; — assume full responsibility for test results. Test reports submitted by the manufacturer shall only be taken into account if they have been issued by conformity assessment bodies which are competent and independent of the manufacturer. Verification by examination and testing of every product batch The notified body shall: (a) have documented procedures, sufficient expertise and facilities for the verification by examination and testing of every product batch in accordance with Annexes IX and XI; (b) establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility in order to: — verify, for class C devices, the conformity of the device with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to those devices, — confirm, for class B devices, the conformity with the technical documentation referred to in Annexes II and III and with the requirements of this Regulation which apply to those devices, (c) document its rationale for the selection of the parameters referred to in point (b); (d) have documented procedures to carry out the appropriate assessments and tests in order to verify the conformity of the device with the requirements of this Regulation by examining and testing every product batch as specified in Section 5 of Annex XI; (e) have documented procedures providing for the reaching of an agreement with the applicant concerning when and where necessary tests that are not to be carried out by the notified body itself are to be performed; (f) assume full responsibility for test results in accordance with documented procedures; test reports submitted by the manufacturer shall only be taken into account if they have been issued by conformity assessment bodies which are competent and independent of the manufacturer. 4.5.4. Performance evaluation assessment The assessment by notified bodies of procedures and documentation shall address the results of literature searches and all validation, verification and testing performed and conclusions drawn, and shall typically include considering the use of alternative materials and substances and take account of the packaging, stability including shelf life of the finished device. Where no new testing has been undertaken by a manufacturer or where there have been deviations from procedures, the notified body in question shall critically examine the justification presented by the manufacturer. The notified body shall have documented procedures in place relating to the assessment of a manufacturer's procedures and documentation relating to performance evaluation both for initial conformity assessment and on an ongoing basis. The notified body shall examine, validate and verify that the manufacturer's procedures and documentation adequately address: (a) the planning, conduct, assessment, reporting and updating of the performance evaluation as referred to in Annex XIII, (b) post-market surveillance and post-market performance follow up, (c) the interface with the risk management process, (d) the appraisal and analysis of the available data and its relevance with regard to demonstrating conformity with the relevant requirements in Annex I, (e) the conclusions drawn with regard to the clinical evidence and drawing up of the performance evaluation report. The procedures referred to in the second paragraph shall take into consideration available CS, guidance and best practice documents. The notified body's assessment of performance evaluations as referred to in Annex XIII shall cover: — the intended use specified by the manufacturer and claims for the device defined by it, — the planning of the performance evaluation, — the methodology for the literature search, — relevant documentation from the literature search, — the performance studies, — post-market surveillance and post-market performance follow up, — validity of equivalence claimed in relation to other devices, the demonstration of equivalence, the suitability and conclusions data from equivalent and similar devices, — the performance evaluation report, — justifications in relation to non-performance of performance studies or PMPF. In relation to data from performance studies included within the performance evaluation, the notified body in question shall ensure that the conclusions drawn by the manufacturer are valid in the light of the approved performance study plan. The notified body shall ensure that the performance evaluation adequately addresses the relevant safety and performance requirements provided for in Annex I, that it is appropriately aligned with the risk management requirements and that it is conducted in accordance with Annex XIII and that it is appropriately reflected in the information provided relating to the device. 4.5.5. Specific Procedures The notified body shall have documented procedures, sufficient expertise and facilities for the procedures referred to in Section 5 of Annex IX, for which they are designated. In the case of companion diagnostics, the notified body shall have documented procedures in place that aim to fulfil the requirements of this Regulation in relation to consultation of the EMA or a medicinal products competent authority during its assessment of such types of device. 4.6. Reporting The notified body shall: — ensure that all steps of the conformity assessment are documented so that the conclusions of the assessment are clear and demonstrate compliance with the requirements of this Regulation and can represent objective evidence of such compliance to persons that are not themselves involved in the assessment, for example personnel in designating authorities, — ensure that records that are sufficient to provide a discernible audit trail are available for quality management system audits, — clearly document the conclusions of its assessment of performance evaluation in a performance evaluation assessment report, — for each specific project, provide a detailed report which shall be based on a standard format containing a minimum set of elements determined by the MDCG. The report of the notified body shall: — clearly document the outcome of its assessment and draw clear conclusions from the verification of the manufacturer's conformity with the requirements of this Regulation, — make a recommendation for a final review and for a final decision to be taken by the notified body; this recommendation shall be signed off by the member of personnel responsible in the notified body, — be provided to the manufacturer in question. 4.7. Final review The notified body shall prior to making a final decision: — ensure that the personnel assigned for the final review and decision making on specific projects are appropriately authorised and are different from the personnel who have conducted the assessments, — verify that the report or reports and supporting documentation needed for decision making, including concerning resolution of non-conformities noted during assessment, are complete and sufficient with respect to the scope of the application, and — verify whether there are any unresolved non-conformities preventing issuance of a certificate. 4.8. Decisions and certifications The notified body shall have documented procedures for decision-making including as regards the allocation of responsibilities for the issuance, suspension, restriction and withdrawal of certificates. Those procedures shall include the notification requirements laid down in Chapter V of this Regulation. The procedures shall allow the notified body in question to: — decide, based on the assessment documentation and additional information available whether the requirements of this Regulation are fulfilled, — decide, based on the results of its assessment of the performance evaluation and risk management whether the post-market surveillance plan, including the PMPF plan, is adequate, — decide on specific milestones for further review by the notified body of the up to date performance evaluation, — decide whether specific conditions or provisions need to be defined for the certification, — decide, based on the novelty, risk classification, performance evaluation and conclusions from the risk analysis of the device, on a period of certification not exceeding five years, — clearly document decision making and approval steps including approval by signature of the members of personnel responsible, — clearly document responsibilities and mechanisms for communication of decisions, in particular, where the final signatory of a certificate differs from the decision maker or decision makers or does not fulfil the requirements laid down in Section 3.2.7., — issue a certificate or certificates in accordance with the minimum requirements laid down in Annex XII for a period of validity not exceeding five years and shall indicate whether there are specific conditions or limitations associated with the certification, — issue a certificate or certificates for the applicant alone and shall not issue certificates covering multiple entities, — ensure that the manufacturer is notified of the outcome of the assessment and the resultant decision and that they are entered into the electronic system referred to in Article 52. 4.9. Changes and modifications The notified body shall have documented procedures and contractual arrangements with manufacturers in place relating to the manufacturers' information obligations and the assessment of changes to: — the approved quality management system or systems or to the product-range covered, — the approved design of a device, — the approved type of a device, — any substance incorporated in or utilised for the manufacturing of a device and being subject to the specific procedures in accordance with Section 4.5.5. The procedures and contractual arrangements referred to in the first paragraph shall include measures for checking the significance of the changes referred to in the first paragraph. In accordance with its documented procedures, the notified body in question shall: — ensure that manufacturers submit for prior approval plans for changes as referred to in the first paragraph and relevant information relating to such changes, — assess the changes proposed and verify whether, after these changes, the quality management system, or the design of a device or type of a device, still meets the requirements of this Regulation, — notify the manufacturer of its decision and provide a report or, as applicable, a supplementary report, which shall contain the justified conclusions of its assessment. 4.10. Surveillance activities and post-certification monitoring The notified body shall have documented procedures: — defining how and when surveillance activities of manufacturers are to be conducted. Those procedures shall include arrangements for unannounced on-site audits of manufacturers and, where applicable, subcontractors and suppliers carrying out product tests and the monitoring of compliance with any conditions binding manufacturers and associated with certification decisions, such as updates to clinical data at defined intervals, — for screening relevant sources of scientific and clinical data and post-market information relating to the scope of their designation. Such information shall be taken into account in the planning and conduct of surveillance activities, — to review vigilance data to which they have access under to Article 87 in order to estimate its impact, if any, on the validity of existing certificates. The results of the evaluation and any decisions taken shall be thoroughly documented. The notified body in question shall, upon receipt of information about vigilance cases from a manufacturer or competent authorities, decide on which of the following options to apply: — not to take action on the basis that the vigilance case is clearly not related to the certification granted, — observe the manufacturer's and competent authorities' activities and the results of the manufacturer's investigation so as to determine whether the certification granted is at risk or whether adequate corrective action has been taken, — perform extraordinary surveillance measures, such as document reviews, short-notice or unannounced audits and product testing, where it is likely that the certification granted is at risk, — increase the frequency of surveillance audits, — review specific products or processes on the occasion of the next audit of the manufacturer, or — take any other relevant measure. In relation to surveillance audits of manufacturers, the notified body shall have documented procedures to: — conduct surveillance audits of the manufacturer on at least an annual basis which shall be planned and conducted in line with the relevant requirements in Section 4.5., — ensure that it adequately assesses the manufacturer's documentation on, and application of, the provisions on vigilance, the post-market surveillance and PMPF, — sample and test devices and technical documentation, during audits, according to pre-defined sampling criteria and testing procedures to ensure that the manufacturer continuously applies the approved quality management system, — ensure that the manufacturer complies with the documentation and information obligations laid down in the relevant Annexes and that its procedures take into account best practices in the implementation of quality management systems, — ensure that the manufacturer does not use quality management system or device approvals in a misleading manner, — gather sufficient information to determine if the quality management system continues to comply with the requirements of this Regulation, — ask the manufacturer, if non-conformities are detected, for corrections, corrective actions, and where applicable preventive actions, and — where necessary, impose specific restrictions on the relevant certificate, or suspend or withdraw it. The notified body shall, if listed as part of the conditions for certification: — conduct an in-depth review of the performance evaluation as most recently updated by the manufacturer based on the manufacturer's post-market surveillance, on its PMPF and on clinical literature relevant to the condition being treated with the device or on clinical literature relevant to similar devices, — clearly document the outcome of the in-depth review and address any specific concerns to the manufacturer or impose any specific conditions on it, — ensure that the performance evaluation as most recently updated is appropriately reflected in the instructions for use and, where applicable, the summary of safety and performance. 4.11. Re-certification The notified body shall have documented procedures in place relating to the re-certification reviews and the renewal of certificates. Re-certification of approved quality management systems or EU technical documentation assessment certificates or EU type-examination certificates shall occur at least every five years. The notified body shall have documented procedures relating to renewals of EU technical documentation assessment certificates and EU type-examination certificates and those procedures shall require the manufacturer in question to submit a summary of changes and scientific findings for the device, including: (a) all changes to the originally approved device, including changes not yet notified, (b) experience gained from post-market surveillance, (c) experience from risk-management, (d) experience from updating the proof of compliance with the general safety and performance requirements set out in Annex I, (e) experience from reviews of the performance evaluation, including the results of any performance studies and PMPF, (f) changes to the requirements, to components of the device or to the scientific or regulatory environment, (g) changes to applied or new harmonised standards, CS or equivalent documents, and (h) changes in medical, scientific and technical knowledge, such as: — new treatments, — changes in test methods, — new scientific findings on materials and components, including findings on their biocompatibility, — experience from studies on comparable devices, — data from registers and registries, — experience from performance studies with comparable devices. The notified body shall have documented procedures to assess the information referred to in the second paragraph and shall pay particular attention to clinical data from post-market surveillance and PMPF activities undertaken since the previous certification or re-certification, including appropriate updates to manufacturers' performance evaluation reports. For the decision on the re-certification, the notified body in question shall use the same methods and principles as for the initial certification decision. If necessary, separate forms shall be established for re-certification taking into account the steps to be taken for certification, such as application and application review. ANNEX VIII CLASSIFICATION RULES 1. IMPLEMENTING RULES 1.1. Application of the classification rules shall be governed by the intended purpose of the devices. 1.2. If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. 1.3. Accessories for an in vitro diagnostic medical device shall be classified in their own right separately from the device with which they are used. 1.4. Software, which drives a device or influences the use of a device, shall fall within the same class as the device. If the software is independent of any other device, it shall be classified in its own right. 1.5. Calibrators intended to be used with a device shall be classified in the same class as the device. 1.6. Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes shall be classified in the same class as the device. 1.7. The manufacturer shall take into consideration all classification and implementation rules in order to establish the proper classification for the device. 1.8. Where a manufacturer states multiple intended purposes for a device, and as a result the device falls into more than one class, it shall be classified in the higher class. 1.9. If several classification rules apply to the same device, the rule resulting in the higher classification shall apply. 1.10. Each of the classification rules shall apply to first line assays, confirmatory assays and supplemental assays. 2. CLASSIFICATION RULES 2.1. Rule 1 Devices intended to be used for the following purposes are classified as class D: — detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration; — detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation; — determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management. 2.2. Rule 2 Devices intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration, are classified as class C, except when intended to determine any of the following markers: — ABO system [A (ABO1), B (ABO2), AB (ABO3)]; — Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]; — Kell system [Kel1 (K)]; — Kidd system [JK1 (Jka), JK2 (Jkb)]; — Duffy system [FY1 (Fya), FY2 (Fyb)]; in which case they are classified as class D. 2.3. Rule 3 Devices are classified as class C if they are intended: (a) for detecting the presence of, or exposure to, a sexually transmitted agent; (b) for detecting the presence in cerebrospinal fluid or blood of an infectious agent without a high or suspected high risk of propagation; (c) for detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested, or to the individual's offspring; (d) for pre-natal screening of women in order to determine their immune status towards transmissible agents; (e) for determining infective disease status or immune status, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring; (f) to be used as companion diagnostics; (g) to be used for disease staging, where there is a risk that an erroneous result would lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring; (h) to be used in screening, diagnosis, or staging of cancer; (i) for human genetic testing; (j) for monitoring of levels of medicinal products, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in a life-threatening situation for the patient or for the patient's offspring; (k) for management of patients suffering from a life-threatening disease or condition; (l) for screening for congenital disorders in the embryo or foetus; (m) for screening for congenital disorders in new-born babies where failure to detect and treat such disorders could lead to life-threatening situations or severe disabilities. 2.4. Rule 4 (a) Devices intended for self-testing are classified as class C, except for devices for the detection of pregnancy, for fertility testing and for determining cholesterol level, and devices for the detection of glucose, erythrocytes, leucocytes and bacteria in urine, which are classified as class B. (b) Devices intended for near-patient testing are classified in their own right. 2.5. Rule 5 The following devices are classified as class A: (a) products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination; (b) instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures; (c) specimen receptacles. 2.6. Rule 6 Devices not covered by the above-mentioned classification rules are classified as class B. 2.7. Rule 7 Devices which are controls without a quantitative or qualitative assigned value are classified as class B. ANNEX IX CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION CHAPTER I QUALITY MANAGEMENT SYSTEM 1. The manufacturer shall establish, document and implement a quality management system, as described in Article 10(8), and maintain its effectiveness throughout the life cycle of the devices concerned. The manufacturer shall ensure the application of the quality management system as specified in Section 2, and shall be subject to audit as laid down in Sections 2.3 and 2.4 and to surveillance as specified in Section 3. 2. Quality management system assessment 2.1. The manufacturer shall lodge an application for assessment of its quality management system with a notified body. The application shall include: — the name of the manufacturer and address of its registered place of business and any additional manufacturing site covered by the quality management system, and, if the manufacturer's application is lodged by its authorised representative the name of the authorised representative and the address of the authorised representative's registered place of business, — all relevant information on the device or group of devices covered by the quality management system, — a written declaration that no application has been lodged with any other notified body for the same device-related quality management system, or information about any previous application for the same device-related quality management system, — a draft of an EU declaration of conformity in accordance with Article 17 and Annex IV for the device model covered by the conformity assessment procedure, — the documentation on the manufacturer's quality management system, — a documented description of the procedures in place to fulfil the obligations arising from by the quality management system and required under this Regulation and of the undertaking by the manufacturer in question to apply those procedures, — a description of the procedures in place to ensure that the quality management system remains adequate and effective, and the undertaking by the manufacturer to apply those procedures, — the documentation on the manufacturer's post-market surveillance system, and, where applicable, on the PMPF plan, and the procedures put in place to ensure compliance with the obligations resulting from the provisions on vigilance set out in Articles 82 to 87, — a description of the procedures in place to keep up to date the post-market surveillance system and, where applicable, the PMPF plan, and the procedures ensuring compliance with the obligations resulting from the provisions on vigilance set out in Articles 82 to 87, as well as the undertaking by the manufacturer to apply those procedures, — documentation on the performance evaluation plan, and — a description of the procedures in place to keep up to date the performance evaluation plan, taking into account the state of the art. 2.2. Implementation of the quality management system shall ensure compliance with this Regulation. All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be documented in a systematic and orderly manner in the form of a quality manual and written policies and procedures, such as quality programmes, quality plans and quality records. Moreover, the documentation to be submitted for the assessment of the quality management system shall include an adequate description of, in particular: (a) the manufacturer's quality objectives; (b) the organisation of the business and in particular: — the organisational structures with the assignment of staff responsibilities in relation to critical procedures, the responsibilities of the managerial staff and their organisational authority, — the methods of monitoring whether the operation of the quality management system is efficient and in particular the ability of that system to achieve the desired design and device quality, including control of devices which fail to conform, — where the design, manufacture, and/or final verification and testing of the devices, or parts of any of those processes, is carried out by another party, the methods of monitoring the efficient operation of the quality management system and in particular the type and extent of control applied to the other party, — where the manufacturer does not have a registered place of business in a Member State, the draft mandate for the designation of an authorised representative and a letter of intention from the authorised representative to accept the mandate; (c) the procedures and techniques for monitoring, verifying, validating and controlling the design of the devices, and the corresponding documentation as well as the data and records arising from those procedures and techniques. Those procedures and techniques shall specifically cover: — the strategy for regulatory compliance, including processes for identification of relevant legal requirements, qualification, classification, handling of equivalence, choice of, and compliance with, conformity assessment procedures, — identification of applicable general safety and performance requirements and solutions to fulfil those requirements, taking applicable CS into account and, where opted for, harmonised standards, — risk management as referred to in Section 3 of Annex I, — the performance evaluation, pursuant to Article 56 and Annex XIII, including PMPF, — solutions for fulfilling the applicable specific requirements regarding design and construction, including appropriate pre-clinical evaluation, in particular the requirements of Chapter II of Annex I, — solutions for fulfilling the applicable specific requirements regarding the information to be supplied with the device, in particular the requirements of Chapter III of Annex I, — the device identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture, and — management of design or quality management system changes; (d) the verification and quality assurance techniques at the manufacturing stage and in particular the processes and procedures which are to be used, particularly as regards sterilisation, and the relevant documents, and (e) the appropriate tests and trials which are to be carried out before, during and after manufacture, the frequency with which they are to take place, and the test equipment to be used; it shall be possible to trace back adequately the calibration of that test equipment. In addition, the manufacturer shall grant the notified body access to the technical documentation referred to in Annexes II and III. 2.3. Audit The notified body shall audit the quality management system to determine whether it meets the requirements referred to in Section 2.2. Where the manufacturer uses a harmonised standard or CS related to a quality management system, the notified body shall assess conformity with those standards or CS. The notified body shall assume that a quality management system which satisfies the relevant harmonised standards or CS conforms to the requirements covered by those standards or CS, unless it duly substantiate not doing so. The audit team of the notified body shall include at least one member with past experience of assessments of the technology concerned in accordance with Sections 4.3. to 4.5. of Annex VII. In circumstances where such experience is not immediately obvious or applicable, the notified body shall provide a documented rationale for the composition of that team. The assessment procedure shall include an audit on the manufacturer's premises and, if appropriate, on the premises of the manufacturer's suppliers and/or subcontractors to verify the manufacturing and other relevant processes. Moreover, in the case of class C devices, the quality management system assessment shall be accompanied by the assessment of the technical documentation for devices selected on a representative basis in accordance with provisions in Sections 4.4 to 4.8. In choosing representative samples the notified body shall take into account the published guidance developed by the MDCG pursuant to Article 99 and in particular, the novelty of the technology, the potential impact on the patient and standard medical practice, similarities in design, technology, manufacturing and, where applicable, sterilisation methods, the intended purpose and the results of any previous relevant assessments that have been carried out in accordance with this Regulation. The notified body in question shall document its rationale for the samples taken. If the quality management system conforms to the relevant provisions of this Regulation, the notified body shall issue an EU quality management system certificate. The notified body shall notify the manufacturer of tits decision to issue the certificate. The decision shall contain the conclusions of the audit and a reasoned report. 2.4. The manufacturer in question shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system, or the device-range covered. The notified body shall assess the changes proposed, determine the need for additional audits and verify whether, after those changes, the quality management system still meets the requirements referred to in Section 2.2. It shall notify the manufacturer of its decision which shall contain the conclusions of the assessment, and where applicable, conclusions of additional audits. The approval of any substantial change to the quality management system or the device-range covered shall take the form of a supplement to the EU quality management system certificate. 3. Surveillance assessment applicable to class C and class D devices 3.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality management system. 3.2. The manufacturer shall give authorisation to the notified body to carry out all the necessary audits, including on-site audits, and supply it with all relevant information, in particular: — the documentation on its quality management system, — the documentation on any findings and conclusions resulting from the application of the post-market surveillance plan, including the PMPF plan, for a representative sample of devices, and of the provisions on vigilance set out in Articles 82 to 87, — the data stipulated in the part of the quality management system relating to design, such as the results of analyses, calculations, tests and the solutions adopted regarding the risk-management as referred to in Section 4 of Annex I, — the data stipulated in the part of the quality management system relating to manufacture, such as quality control reports and test data, calibration data, and records on the qualifications of the personnel concerned. 3.3. Notified bodies shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer in question applies the approved quality management system and the post-market surveillance plan. Those audits and assessments shall include audits on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors. At the time of such on-site audits, the notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly. It shall provide the manufacturer with a surveillance audit report and, if a test has been carried out, with a test report. 3.4. The notified body shall randomly perform at least once every five years unannounced audits on the site of the manufacturer and, where appropriate, the site of the manufacturer's suppliers and/or subcontractors, which may be combined with the periodic surveillance assessment referred to in Section 3.3 or be performed in addition to that surveillance assessment. The notified body shall establish a plan for such unannounced on-site audits but shall not disclose it to the manufacturer. Within the context of such unannounced on-site audits, the notified body shall test an adequate sample of the devices produced or an adequate sample from the manufacturing process to verify that the manufactured device is in conformity with the technical documentation. Prior to unannounced on-site audits, the notified body shall specify the relevant sampling criteria and testing procedure. Instead of, or in addition to, sampling referred to in the second paragraph, notified bodies shall take samples of devices from the market to verify that the manufactured device is in conformity with the technical documentation. Prior to the sampling, the notified body in question shall specify the relevant sampling criteria and testing procedure. The notified body shall provide the manufacturer in question with an on-site audit report which shall include, if applicable, the result of the sample test. 3.5. In the case of class C devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 of for the device or devices concerned on the basis of further representative samples chosen in accordance with the rationale documented by the notified body in accordance with the third paragraph of Section 2.3. 3.6. Notified bodies shall ensure that the composition of the assessment team is such that there is sufficient experience with the evaluation of the devices, systems and processes concerned, continuous objectivity and neutrality; this shall include a rotation of the members of the assessment team at appropriate intervals. As a general rule, a lead auditor shall neither lead nor attend audits for more than three consecutive years in respect of the same manufacturer. 3.7. If the notified body finds a divergence between the sample taken from the devices produced or from the market and the specifications laid down in the technical documentation or the approved design, it shall suspend or withdraw the relevant certificate or impose restrictions on it. CHAPTER II ASSESSMENT OF THE TECHNICAL DOCUMENTATION 4. Assessment of the technical documentation of class B, C and D devices and batch verification applicable to class D devices 4.1. In addition to the obligation laid down in Section 2, the manufacturer of devices shall lodge with the notified body an application for the assessment of the technical documentation relating to the device which it plans to place on the market or put into service and which is covered by the quality management system referred to in Section 2. 4.2. The application shall describe the design, manufacture and performance of the device in question. It shall include the technical documentation as referred to in Annexes II and III. In the case of devices for self-testing or near-patient testing, the application shall also include the aspects referred to in point (b) of Section 5.1. 4.3. The notified body shall examine the application by using staff, employed by it, with proven knowledge and experience in the evaluation of the technology, and the devices concerned and the evaluation of clinical evidence. The notified body may require the application to be completed by having further tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant requirements of this Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests. 4.4. The notified body shall review the clinical evidence presented by the manufacturer in the performance evaluation report and the related performance evaluation that was conducted. The notified body shall use employed device reviewers with sufficient clinical expertise and including external clinical experts with direct and current experience relating to the clinical application of the device in question for the purposes of that review. 4.5. The notified body shall, in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity. 4.6. The notified body shall verify that the clinical evidence and the performance evaluation are adequate and shall verify the conclusions drawn by the manufacturer on the conformity with the relevant general safety and performance requirements. That verification shall include consideration of the adequacy of the benefit-risk determination, the risk management, the instructions for use, the user training and the manufacturer's post-market surveillance plan, and include a review of the need for, and the adequacy of, the PMPF plan proposed, where applicable. 4.7. Based on its assessment of the clinical evidence, the notified body shall consider the performance evaluation and the benefit-risk determination, and whether specific milestones need to be defined to allow the notified body to review updates to the clinical evidence that result from post-market surveillance and PMPF data. 4.8. The notified body shall clearly document the outcome of its assessment in the performance evaluation assessment report. 4.9. Before issuing an EU technical documentation assessment certificate, the notified body shall request an EU reference laboratory, where designated in accordance with Article 100, to verify the performance claimed by the manufacturer and the compliance of the device with the CS, where available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The verification shall include laboratory tests by the EU reference laboratory as referred to in Article 48(5). In addition, the notified body shall, in the cases referred to in Article 48(6) of this Regulation, consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 in accordance with the procedure laid down in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer. The EU reference laboratory shall provide a scientific opinion within 60 days. The scientific opinion of the EU reference laboratory and, where applicable, the views of the experts consulted, pursuant to the procedure laid down in Article 48(6), and any possible updates shall be included in the documentation of the notified body concerning the device. The notified body shall, when making its decision, give due consideration to the views expressed in the scientific opinion of the EU reference laboratory, and, where applicable, to the views expressed by the experts consulted pursuant to Article 48(6). The notified body shall not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable. 4.10. The notified body shall provide the manufacturer with a report on the technical documentation assessment, including a performance evaluation assessment report. If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU technical documentation assessment certificate. The certificate shall contain the conclusions of the technical documentation assessment, the conditions of the certificate's validity, the data needed for identification of the approved device, and, where appropriate, a description of the intended purpose of the device. 4.11. Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate, where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce any of the above-mentioned changes it shall inform the notified body which issued the EU technical documentation assessment certificate thereof. The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 48 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide it with a supplement to the EU technical documentation assessment certificate. Where the changes could affect compliance with the CS or with other solutions chosen by the manufacturer which were approved through the EU technical documentation assessment certificate, the notified body shall consult the EU reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CS or with other solutions chosen by the manufacturer, to ensure a level of safety and performance that is at least equivalent, is maintained. The EU reference laboratory shall provide a scientific opinion within 60 days. 4.12. To verify conformity of manufactured class D devices, the manufacturer shall carry out tests on each manufactured batch of devices. After the conclusion of the controls and tests, it shall forward to the notified body, without delay, the relevant reports on those tests. Furthermore, the manufacturer shall make the samples of manufactured batches of devices available to the notified body in accordance with pre-agreed conditions and detailed arrangements which shall include that the notified body or the manufacturer shall send samples of the manufactured batches of devices to the EU reference laboratory, where such a laboratory has been designated in accordance with Article 100, to carry out appropriate tests. The EU reference laboratory shall inform the notified body about its findings. 4.13. The manufacturer may place the devices on the market, unless the notified body communicates to the manufacturer within the agreed timeframe, but not later than 30 days after reception of the samples, any other decision, including in particular any condition of validity of delivered certificates. 5. Assessment of the technical documentation of specific types of devices 5.1. Assessment of the technical documentation of class B, C and D devices for self-testing and near-patient testing (a) The manufacturer of class B, C and D devices for self-testing and near-patient testing shall lodge with the notified body an application for the assessment of the technical documentation. (b) The application shall enable the design of the device characteristics and performance(s) to be understood and shall enable conformity with the design-related requirements of this Regulation to be assessed. It shall include: (i) test reports, including results of studies carried out with intended users; (ii) where practicable, an example of the device; if required, the device shall be returned on completion of the technical documentation assessment; (iii) data showing the suitability of the device in view of its intended purpose for self-testing or near patient-testing; (iv) the information to be provided with the device on its label and its instructions for use. The notified body may require the application to be completed by carrying out further tests or by providing further proof to allow assessment of conformity with the requirements of this Regulation. (c) The notified body shall verify the compliance of the device with the relevant requirements set out in Annex I of this Regulation. (d) The notified body shall assess the application, by using staff, employed by it, with proven knowledge and experience regarding the technology concerned and the intended purpose of the device and provide the manufacturer with a technical documentation assessment report. (e) If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU technical documentation assessment certificate. The certificate shall contain the conclusions of the assessment, the conditions of its validity, the data needed for the identification of the approved devices and, where appropriate, a description of the intended purpose of the device. (f) Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate, where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device. Where the manufacturer plans to introduce any of the above-mentioned changes, it shall inform the notified body which issued the EU technical documentation assessment certificate thereof. The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 48 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified body shall assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide it with a supplement to the EU technical documentation assessment certificate. 5.2. Assessment of the technical documentation of companion diagnostics (a) The manufacturer of a companion diagnostic shall lodge with the notified body an application for the assessment of the technical documentation. The notified body shall assess that application in accordance with the procedure laid down in Sections 4.1 to 4.8 of this Annex. (b) The application shall enable the characteristics and performance of the device to be understood, and shall enable conformity with the design-related requirements of this Regulation to be assessed, in particular, with regard to the suitability of the device in relation to the medicinal product concerned. (c) The notified body shall, before issuing an EU technical documentation assessment certificate for the companion diagnostic and on the basis of the draft summary of safety and performance and the draft instructions for use, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this point, regarding the suitability of the device in relation to the medicinal product concerned. Where the medicinal product falls exclusively within the scope of the Annex to Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), the notified body shall seek the opinion of the EMA. If the medicinal product concerned is already authorised, or if an application for its authorisation has been submitted, the notified body shall consult the medicinal products authority, or the EMA, that is responsible for the authorisation. (d) The medicinal products authority consulted shall provide its opinion, within 60 days of receipt of all the necessary documentation. This 60-day period may be extended once for a further 60 days on justified grounds. The opinion and any possible update shall be included in the documentation of the notified body concerning the device. (e) The notified body shall give due consideration to the scientific opinion referred to in point (d) when making its decision. The notified body shall convey its final decision to the medicinal products authority consulted. The EU technical documentation assessment certificate shall be delivered in accordance with point (e) of Section 5.1. (f) Before changes affecting the performance and/or the intended use and/or the suitability of the device in relation to the medicinal product concerned are made, the manufacturer shall inform the notified body of the changes. The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 48 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified body shall assess the changes and seek the opinion of the medicinal products authority consulted. The medicinal products authority consulted shall give its opinion within 30 days of receipt of the all the necessary documentation regarding the changes. A supplement to the EU technical documentation assessment certificate shall be issued in accordance with point (f) of Section 5.1. CHAPTER III ADMINISTRATIVE PROVISIONS 6. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, it's authorised representative shall, for a period ending no sooner than 10 years after the last device has been placed on the market, keep at the disposal of the competent authorities: — the EU declaration of conformity, — the documentation referred to in the fifth indent of Section 2.1. and, in particular, the data and records arising from the procedures referred to in point (c) of the second paragraph of Section 2.2., — information on the changes referred to in Section 2.4., — the documentation referred to in Sections 4.2. and point (b) of Section 5.1., and — the decisions and reports from the notified body as referred to in this Annex. 7. Each Member State shall require that the documentation referred to in Section 6 is kept at the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of that period. (1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). ANNEX X CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION 1. EU type-examination is the procedure whereby a notified body ascertains and certifies that a device, including its technical documentation and relevant life cycle processes and a corresponding representative sample of the device production envisaged, fulfils the relevant provisions of this Regulation. 2. Application The manufacturer shall lodge an application for assessment with a notified body. The application shall include: — the name of the manufacturer and the address of its registered place of business and, if the application is lodged by the authorised representative, the name of the authorised representative and the address of its registered place of business, — the technical documentation referred to in Annexes II and III. The applicant shall make a representative sample of the device production envisaged (‘type’) available to the notified body. The notified body may request other samples as necessary, — in the case of devices for self-testing or near-patient testing, test reports, including results of studies carried out with intended users, and data showing the handling suitability of the device in relation to its intended purpose for self-testing or near patient-testing, — where practicable, an example of the device. If required, the device shall be returned on completion of the technical documentation assessment; — data showing the suitability of the device in relation to its intended purpose for self-testing or near-patient testing, — the information to be provided with the device on its label and its instructions for use, and — a written declaration that no application has been lodged with any other notified body for the same type, or information about any previous application for the same type that was refused by another notified body or was withdrawn by the manufacturer or its authorised representative before that other notified body made its final assessment. 3. Assessment The notified body shall: (a) examine the application, by using staff with proven knowledge and experience in the evaluation of the technology, and the devices concerned and the evaluation of clinical evidence. The notified body may require the application to be completed by having further tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant requirements of this Regulation. The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests; (b) examine and assess the technical documentation for conformity with the requirements of this Regulation that are applicable to the device and verify that the type has been manufactured in conformity with that documentation; it shall also record the items designed in conformity with the applicable standards referred to in Article 8 or with applicable CS, and record items not designed on the basis of the relevant standards referred to in Article 8 or of the relevant CS; (c) review the clinical evidence presented by the manufacturer in the performance evaluation report in accordance with Section 1.3.2 of Annex XIII. The notified body shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the clinical application of the device in question for the purposes of that review; (d) in circumstances in which the clinical evidence is partly or totally based on data from devices which are claimed to be similar or equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity; (e) clearly document the outcome of its assessment in the performance evaluation assessment report referred to in Section 4.8 of Annex IX; (f) carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether the solutions adopted by the manufacturer meet the general safety and performance requirements laid down in this Regulation in the event that the standards referred to in Article 8 or the CS have not been applied. Where the device has to be connected to another device or devices in order to operate as intended, proof shall be provided that it conforms to the general safety and performance requirements when connected to any such device or devices having the characteristics specified by the manufacturer; (g) carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether, in the event that the manufacturer has chosen to apply the relevant harmonised standards, those standards have actually been applied; (h) agree with the applicant on the place where the necessary assessments and tests are to be carried out; (i) draw up an EU type-examination report on the results of the assessments and tests carried out under points (a) to (g); (j) in the case of class D devices, request the EU reference laboratory, where designated in accordance with Article 100, to verify the performance claimed by the manufacturer and the compliance of the device with the CS, where available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent. The verification shall include laboratory tests by the EU reference laboratory in accordance with Article 48(5). In addition, the notified body shall, in the cases referred to in Article 48(6) of this Regulation, consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 following the procedure laid down in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer. The EU reference laboratory shall provide a scientific opinion within 60 days. The scientific opinion of the EU reference laboratory and, where the procedure laid down in Article 48(6) is applicable, the views of the experts consulted, and any possible updates shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the views expressed in the scientific opinion of the EU reference laboratory, and, where applicable, to the views expressed by the experts consulted in accordance with Article 48(6), when making its decision. The notified body shall not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable; (k) for companion diagnostics, seek the opinion, on the basis of the draft summary of safety and performance and the draft instructions for use, of one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMA (either of which to be hereinafter referred to as ‘the medicinal products authority consulted’ depending on which has been consulted under this point) on the suitability of the device in relation to the medicinal product concerned. Where the medicinal product falls exclusively within the scope of the Annex of Regulation (EC) No 726/2004, the notified body shall consult the EMA. If the medicinal product concerned is already authorised, or if an application for its authorisation has been submitted, the notified body shall consult the medicinal products competent authority, or the EMA, that is responsible for the authorisation. The medicinal products authority consulted shall deliver its opinion within 60 days of receipt of all the necessary documentation. This 60-day period may be extended once for a further 60 days on justified grounds. The opinion of the medicinal products authority consulted and any possible update shall be included in the documentation of the notified body concerning the device. The notified body shall give due consideration to the opinion expressed by the medicinal products authority consulted when making its decision. It shall convey its final decision to the medicinal products authority consulted; and (l) draw up an EU type-examination report on the results of the assessments and tests carried out, and scientific opinions provided under, points (a) to (k), including a performance evaluation assessment report for class C or class D devices or covered by the third indent of Section 2. 4. Certificate If the type conforms to this Regulation, the notified body shall issue an EU type-examination certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of the type examination assessment, the conditions of certificate's validity and the data needed for identification of the type approved. The certificate shall be drawn up in accordance with Annex XII. The relevant parts of the documentation shall be annexed to the certificate and a copy kept by the notified body. 5. Changes to the type 5.1. The applicant shall inform the notified body which issued the EU type-examination certificate of any planned change to the approved type or of its intended purpose and conditions of use. 5.2. Changes to the approved device including limitations of its intended purpose and conditions of use shall require further approval from the notified body which issued the EU type-examination certificate where such changes may affect conformity with the general safety and performance requirements or with the conditions prescribed for use of the product. The notified body shall examine the planned changes, notify the manufacturer of its decision and provide him with a supplement to the EU type-examination report. The approval of any change to the approved type shall take the form of a supplement to the EU type-examination certificate. 5.3. Changes to the intended purpose and conditions of use of the approved device, with the exception of limitations of the intended purpose and conditions of use, shall necessitate a new application for a conformity assessment. 5.4. Where the changes could affect the performance claimed by the manufacturer or compliance with the CS or with other solutions chosen by the manufacturer which were approved through the EU type-examination certificate, the notified body shall consult the EU reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent are maintained. The EU reference laboratory shall provide a scientific opinion within 60 days. 5.5. Where the changes affect the performance or the intended use of a companion diagnostic approved through the EU type-examination certificate or its suitability in relation to a medicinal product, the notified body shall consult the medicinal products competent authority that was involved in the initial consultation or the EMA. The medicinal products authority consulted shall give its opinion, if any, within 30 days after receipt of the valid documentation regarding the changes. The approval of any change to the approved type shall take the form of a supplement to the initial EU type-examination certificate. 6. Administrative provisions The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representative shall, for a period ending no sooner than 10 years, after the last device has been placed on the market, keep at the disposal of the competent authorities: — the documentation referred to in the second indent of Section 2, — information on the changes referred to in Section 5, — copies of EU type-examination certificates, scientific opinions and reports and their additions/supplements. Section 7 of Annex IX shall apply. ANNEX XI CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE 1. The manufacturer shall ensure that the quality management system approved for the manufacture of the devices concerned is implemented, shall carry out final verification, as specified in Section 3, and shall be subject to the surveillance referred to in Section 4. 2. When the manufacturer fulfils the obligations laid down in Section 1, it shall draw up and keep an EU declaration of conformity in accordance with Article 17 and Annex IV for the device covered by the conformity assessment procedure. By issuing an EU declaration of conformity, the manufacturer shall be deemed to ensure, and to declare, that the device concerned meets the requirements of this Regulation which apply to the device, and in the case of class C and class D devices that undergo a type examination, conforms to the type described in the EU type-examination certificate. 3. Quality management system 3.1. The manufacturer shall lodge an application for assessment of its quality management system with a notified body. The application shall include: — all elements listed in Section 2.1 of Annex IX, — the technical documentation referred to in Annexes II and III for the types approved, — a copy of the EU type-examination certificates referred to in Section 4 of Annex X; if the EU type-examination certificates have been issued by the same notified body with which the application is lodged, a reference to the technical documentation and its updates and the certificates issued shall also be included in the application. 3.2. Implementation of the quality management system shall be such as to ensure that there is compliance with the type described in the EU type-examination certificate and with the provisions of this Regulation which apply to the devices at each stage. All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be documented in a systematic and orderly manner in the form of a quality manual and written policies and procedures, such as quality programmes, quality plans and quality records. That documentation shall, in particular, include an adequate description of all elements listed in points (a), (b), (d) and (e) of Section 2.2. of Annex IX. 3.3. The first and second paragraphs of Section 2.3 of Annex IX shall apply. If the quality management system is such that it ensures that the devices conform to the type described in the EU type-examination certificate and conform to the relevant provisions of this Regulation, the notified body shall issue an EU production quality assurance certificate. The notified body shall notify the manufacturer of its decision to issue the certificate. That decision shall contain the conclusions of the notified body's audit and a reasoned assessment. 3.4. Section 2.4 of Annex IX shall apply. 4. Surveillance Section 3.1, the first, second and fourth indents of Section 3.2, Sections 3.3, 3.4, 3.6 and 3.7 of Annex IX shall apply. 5. Verification of manufactured class D devices 5.1. In the case of class D devices, the manufacturer shall carry out tests on each manufactured batch of devices. After the conclusion of the controls and tests, it shall forward to the notified body without delay the relevant reports on those tests. Furthermore, the manufacturer shall make samples of manufactured devices or batches of devices available to the notified body in accordance with pre-agreed conditions and detailed arrangements which shall include that the notified body or the manufacturer, shall send samples of the manufactured devices or batches of devices to an EU reference laboratory, where such a laboratory has been designated in accordance with Article 100, to carry out appropriate laboratory tests. The EU reference laboratory shall inform the notified body about its findings. 5.2. The manufacturer may place the devices on the market, unless the notified body communicates to the manufacturer within the agreed timeframe, but not later than 30 days after reception of the samples, any other decision, including in particular any condition of validity of delivered certificates. 6. Administrative provisions The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representative shall, for a period ending no sooner than 10 years after the last device has been placed on the market, keep at the disposal of the competent authorities: — the EU declaration of conformity, — the documentation referred to in the fifth indent of Section 2.1 of Annex IX, — the documentation referred to in the eighth indent of Section 2.1 of Annex IX, including the EU type-examination certificate referred to in Annex X, — information on the changes referred to in Section 2.4 of Annex IX, and — the decisions and reports from the notified body as referred to in Sections 2.3., 3.3. and 3.4. of Annex IX. Section 7 of Annex IX shall apply. ANNEX XII CERTIFICATES ISSUED BY A NOTIFIED BODY CHAPTER I GENERAL REQUIREMENTS 1. Certificates shall be drawn up in one of the official languages of the Union. 2. Each certificate shall refer to only one conformity assessment procedure. 3. Certificates shall only be issued to one manufacturer. The name and address of the manufacturer included in the certificate shall be the same as that registered in the electronic system referred to in Article 27. 4. The scope of the certificates shall unambiguously describe the device or devices covered: (a) EU technical documentation assessment certificates and EU type-examination certificates shall include a clear identification, including the name, model and type, of the device or devices, the intended purpose as indicated by the manufacturer in the instructions for use and in relation to which the device has been assessed in the conformity assessment procedure, risk classification and the Basic UDI-DI as referred to in Article 24(6). (b) EU quality management system certificates and EU production quality assurance certificates shall include the identification of the devices or groups of devices, the risk classification and the intended purpose. 5. The notified body shall be able to demonstrate on request, which (individual) devices are covered by the certificate. The notified body shall set up a system that enables the determination of the devices, including their classification, covered by the certificate. 6. Certificates shall contain, if applicable, a note that, for the placing on the market of the device or devices it covers, another certificate issued in accordance with this Regulation is required. 7. EU quality management system certificates and EU production quality assurance certificates for class A sterile devices shall include a statement that the audit by the notified body was limited to the aspects of manufacture concerned with securing and maintaining sterile conditions. 8. Where a certificate is supplemented, modified or re-issued, the new certificate shall contain a reference to the preceding certificate and its date of issue with identification of the changes. CHAPTER II MINIMUM CONTENT OF THE CERTIFICATES 1. name, address and identification number of the notified body; 2. name and address of the manufacturer and, if applicable, of the authorised representative; 3. unique number identifying the certificate; 4. if already issued, the SRN of the manufacturer referred to in Article 28(2); 5. date of issue; 6. date of expiry; 7. data needed for the unambiguous identification of the device or devices where applicable as specified in Section 4 of this Annex; 8. if applicable, reference to any previous certificate as specified in Section 8 of Chapter I; 9. reference to this Regulation and the relevant Annex in accordance with which the conformity assessment has been carried out; 10. examinations and tests performed, e.g. reference to relevant CS, harmonised standards, test reports and audit report(s); 11. if applicable, reference to the relevant parts of the technical documentation or other certificates required for the placing on the market of the device or devices covered; 12. if applicable, information about the surveillance by the notified body; 13. conclusions of the notified body's conformity assessment with regard to the relevant Annex; 14. conditions for or limitations to the validity of the certificate; 15. legally binding signature of the notified body in accordance with the applicable national law. ANNEX XIII PERFORMANCE EVALUATION, PERFORMANCE STUDIES AND POST-MARKET PERFORMANCE FOLLOW-UP PART A PERFORMANCE EVALUATION AND PERFORMANCE STUDIES 1. PERFORMANCE EVALUATION Performance evaluation of a device is a continuous process by which data are assessed and analysed to demonstrate the scientific validity, analytical performance and clinical performance of that device for its intended purpose as stated by the manufacturer. To plan, continuously conduct and document a performance evaluation, the manufacturer shall establish and update a performance evaluation plan. The performance evaluation plan shall specify the characteristics and the performance of the device and the process and criteria applied to generate the necessary clinical evidence. The performance evaluation shall be thorough and objective, considering both favourable and unfavourable data. Its depth and extent shall be proportionate and appropriate to the characteristics of the device including the risks, risk class, performance and its intended purpose. 1.1. Performance evaluation plan As a general rule, the performance evaluation plan shall include at least: — a specification of the intended purpose of the device; — a specification of the characteristics of the device as described in Section 9 of Chapter II of Annex I and in point (c) of Section 20.4.1. of Chapter III of Annex I; — a specification of the analyte or marker to be determined by the device; — a specification of the intended use of the device; — identification of certified reference materials or reference measurement procedures to allow for metrological traceability; — a clear identification of specified target patient groups with clear indications, limitations and contra-indications; — an identification of the general safety and performance requirements as laid down in Sections 1 to 9 of Annex I that require support from relevant scientific validity and analytical and clinical performance data; — a specification of methods, including the appropriate statistical tools, used for the examination of the analytical and clinical performance of the device and of the limitations of the device and information provided by it; — a description of the state of the art, including an identification of existing relevant standards, CS, guidance or best practices documents; — an indication and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the intended purpose or purposes and for the analytical and clinical performance of the device; — for software qualified as a device, an identification and specification of reference databases and other sources of data used as the basis for its decision making; — an outline of the different development phases including the sequence and means of determination of the scientific validity, the analytical and clinical performance, including an indication of milestones and a description of potential acceptance criteria; — the PMPF planning as referred to in Part B of this Annex. Where any of the above mentioned elements are not deemed appropriate in the Performance Evaluation Plan due to the specific device characteristics a justification shall be provided in the plan. 1.2. Demonstration of the scientific validity and the analytical and clinical performance: As a general methodological principle the manufacturer shall: — identify through a systematic scientific literature review the available data relevant to the device and its intended purpose and identify any remaining unaddressed issues or gaps in the data; — appraise all relevant data by evaluating their suitability for establishing the safety and performance of the device; — generate any new or additional data necessary to address outstanding issues. 1.2.1. Demonstration of the scientific validity The manufacturer shall demonstrate the scientific validity based on one or a combination of the following sources: — relevant information on the scientific validity of devices measuring the same analyte or marker; — scientific (peer-reviewed) literature; — consensus expert opinions/positions from relevant professional associations; — results from proof of concept studies; — results from clinical performance studies. The scientific validity of the analyte or marker shall be demonstrated and documented in the scientific validity report. 1.2.2. Demonstration of the analytical performance The manufacturer shall demonstrate the analytical performance of the device in relation to all the parameters described in point (a) of Section 9.1 of Annex I, unless any omission can be justified as not applicable. As a general rule, the analytical performance shall always be demonstrated on the basis of analytical performance studies. For novel markers or other markers without available certified reference materials or reference measurement procedures, it may not be possible to demonstrate trueness. If there are no comparative methods, different approaches may be used if demonstrated to be appropriate, such as comparison to some other well-documented methods or the composite reference standard. In the absence of such approaches, a clinical performance study comparing performance of the novel device to the current clinical standard practice is required. Analytical performance shall be demonstrated and documented in the analytical performance report. 1.2.3. Demonstration of the clinical performance The manufacturer shall demonstrate the clinical performance of the device in relation to all the parameters described in point (b) of Section 9.1. of Annex I, unless any omission can be justified as not applicable. Demonstration of the clinical performance of a device shall be based on one or a combination of the following sources: — clinical performance studies; — scientific peer-reviewed literature; — published experience gained by routine diagnostic testing. Clinical performance studies shall be performed unless due justification is provided for relying on other sources of clinical performance data. Clinical performance shall be demonstrated and documented in the clinical performance report. 1.3. Clinical evidence and performance evaluation report 1.3.1. The manufacturer shall assess all relevant scientific validity, analytical and clinical performance data to verify the conformity of its device with the general safety and performance requirements as referred to in Annex I. The amount and quality of that data shall allow the manufacturer to make a qualified assessment whether the device will achieve the intended clinical benefit or benefits and safety, when used as intended by the manufacturer. The data and conclusions drawn from this assessment shall constitute the clinical evidence for the device. The clinical evidence shall scientifically demonstrate that the intended clinical benefit or benefits and safety will be achieved according to the state of the art in medicine. 1.3.2. Performance evaluation report The clinical evidence shall be documented in a performance evaluation report. This report shall include the scientific validity report, the analytical performance report, the clinical performance report and an assessment of those reports allowing demonstration of the clinical evidence. The performance evaluation report shall in particular include: — the justification for the approach taken to gather the clinical evidence; — the literature search methodology and the literature search protocol and literature search report of a literature review; — the technology on which the device is based, the intended purpose of the device and any claims made about the device's performance or safety; — the nature and extent of the scientific validity and the analytical and clinical performance data that has been evaluated; — the clinical evidence as the acceptable performances against the state of the art in medicine; — any new conclusions derived from PMPF reports in accordance with Part B of this Annex. 1.3.3. The clinical evidence and its assessment in the performance evaluation report shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer's PMPF plan in accordance with Part B of this Annex, as part of the performance evaluation and the post-market surveillance system referred to in Article 10(9). The performance evaluation report shall be part of the technical documentation. Both favourable and unfavourable data considered in the performance evaluation shall be included in the technical documentation. 2. CLINICAL PERFORMANCE STUDIES 2.1. Purpose of clinical performance studies The purpose of clinical performance studies is to establish or confirm aspects of device performance which cannot be determined by analytical performance studies, literature and/or previous experience gained by routine diagnostic testing. This information is used to demonstrate compliance with the relevant general safety and performance requirements with respect to clinical performance. When clinical performance studies are conducted, the data obtained shall be used in the performance evaluation process and be part of the clinical evidence for the device. 2.2. Ethical considerations for clinical performance studies Each step in the clinical performance study, from the initial consideration of the need for and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles. 2.3. Methods for clinical performance studies 2.3.1. Clinical performance study design type Clinical performance studies shall be designed in such a way as to maximize the relevance of the data while minimising potential bias. 2.3.2. Clinical performance study plan Clinical performance studies shall be performed on the basis of a clinical performance study plan (CPSP). The CPSP shall define the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical performance study. It shall contain in particular the following information: (a) the single identification number of the clinical performance study, as referred to in Article 66(1); (b) identification of the sponsor, including the name, address of the registered place of business and contact details of the sponsor and, if applicable, the name, address of the registered place of business and contact details of its contact person or legal representative pursuant to Article 58(4) established in the Union; (c) information on the investigator or investigators, namely principal, coordinating or other investigator; qualifications; contact details, and investigation site or sites, such as number, qualification, contact details and, in the case of devices for self-testing, the location and number of lay persons involved; (d) the starting date and scheduled duration for the clinical performance study; (e) identification and description of the device, its intended purpose, the analyte or analytes or marker or markers, the metrological traceability, and the manufacturer; (f) information about the type of specimens under investigation; (g) overall synopsis of the clinical performance study, its design type, such as observational, interventional, together with the objectives and hypotheses of the study, reference to the current state of the art in diagnosis and/or medicine; (h) a description of the expected risks and benefits of the device and of the clinical performance study in the context of the state of the art in clinical practice, and with the exception of studies using left-over samples, the medical procedures involved and patient management; (i) the instructions for use of the device or test protocol, the necessary training and experience of the user, the appropriate calibration procedures and means of control, the indication of any other devices, medical devices, medicinal product or other articles to be included or excluded and the specifications on any comparator or comparative method used as reference; (j) description of and justification for the design of the clinical performance study, its scientific robustness and validity, including the statistical design, and details of measures to be taken to minimise bias, such as randomisation, and management of potential confounding factors; (k) the analytical performance in accordance with point (a) of Section 9.1 of Chapter I of Annex I with justification for any omission; (l) parameters of clinical performance in accordance with point (b) of Section 9.1 of Annex I to be determined, with justification for any omission; and with the exception of studies using left-over samples the specified clinical outcomes/endpoints (primary/secondary) used with a justification and the potential implications for individual health and/or public health management decisions; (m) information on the performance study population: specifications of the subjects, selection criteria, size of performance study population, representativity of target population and, if applicable, information on vulnerable subjects involved, such as children, pregnant women, immuno-compromised or elderly subjects; (n) information on use of data out of left over specimens banks, genetic or tissue banks, patient or disease registries etc. with description of reliability and representativity and statistical analysis approach; assurance of relevant method for determining the true clinical status of patient specimens; (o) monitoring plan; (p) data management; (q) decision algorithms; (r) policy regarding any amendments, including those in accordance with Article 71, to or deviations from the CPSP, with a clear prohibition of use of waivers from the CPSP; (s) accountability regarding the device, in particular control of access to the device, follow-up in relation to the device used in the clinical performance study and the return of unused, expired or malfunctioning devices; (t) statement of compliance with the recognised ethical principles for medical research involving humans and the principles of good clinical practice in the field of clinical performance studies as well as with the applicable regulatory requirements; (u) description of the informed consent process, including a copy of the patient information sheet and consent forms; (v) procedures for safety recording and reporting, including definitions of recordable and reportable events, and procedures and timelines for reporting; (w) criteria and procedures for suspension or early termination of the clinical performance study; (x) criteria and procedures for follow up of subjects following completion of a performance study, procedures for follow up of subjects in the case of suspension or early termination, procedures for follow up of subjects who have withdrawn their consent and procedures for subjects lost to follow up; (y) procedures for communication of test results outside the study, including communication of test results to the performance study subjects; (z) policy as regards the establishment of the clinical performance study report and publication of results in accordance with the legal requirements and the ethical principles referred to in Section 2.2; (aa) list of the technical and functional features of the device indicating those that are covered by the performance study; (ab) bibliography. If part of the information referred to in the second paragraph is submitted in a separate document, it shall be referenced in the CPSP. For studies using left-over samples, points (u), (x), (y) and (z) shall not apply. Where any of the elements referred to in the second paragraph are not deemed appropriate for inclusion in the CPSP due to the specific study design chosen, such as use of left-over samples versus interventional clinical performance studies, a justification shall be provided. 2.3.3. Clinical performance study report A clinical performance study report, signed by a medical practitioner or any other authorised person responsible, shall contain documented information on the clinical performance study protocol plan, results and conclusions of the clinical performance study, including negative findings. The results and conclusions shall be transparent, free of bias and clinically relevant. The report shall contain sufficient information to enable it to be understood by an independent party without reference to other documents. The report shall also include as appropriate any protocol amendments or deviations, and data exclusions with the appropriate rationale. 3. OTHER PERFORMANCE STUDIES By analogy, the performance study plan referred to in Section 2.3.2, and the performance study report, referred to in Section 2.3.3, shall be documented for other performance studies than clinical performance studies. PART B POST-MARKET PERFORMANCE FOLLOW-UP 4. PMPF shall be understood to be a continuous process that updates the performance evaluation referred to in Article 56 and Part A of this Annex and shall be specifically addressed in the manufacturer's post-market surveillance plan. When conducting PMPF, the manufacturer shall proactively collect and evaluate performance and relevant scientific data from the use of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety, performance and scientific validity throughout the expected lifetime of the device, of ensuring the continued acceptability of the benefit-risk ratio and of detecting emerging risks on the basis of factual evidence. 5. PMPF shall be performed pursuant to a documented method laid down in a PMPF plan. 5.1. The PMPF plan shall specify the methods and procedures for proactively collecting and evaluating safety, performance and scientific data with the aim of: (a) confirming the safety and performance of the device throughout its expected lifetime, (b) identifying previously unknown risks or limits to performance and contra-indications, (c) identifying and analysing emergent risks on the basis of factual evidence, (d) ensuring the continued acceptability of the clinical evidence and of the benefit-risk ratio referred to in Sections 1 and 8 of Chapter I of Annex I, and (e) identifying possible systematic misuse. 5.2. The PMPF plan shall include at least: (a) the general methods and procedures of the PMPF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of performance or scientific data; (b) the specific methods and procedures of PMPF to be applied, such as ring trials and other quality assurance activities, epidemiological studies, evaluation of suitable patient or disease registers, genetic databanks or post-market clinical performance studies; (c) a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b); (d) a reference to the relevant parts of the performance evaluation report referred to in Section 1.3 of this Annex and to the risk management referred to in Section 3 of Annex I; (e) the specific objectives to be addressed by the PMPF; (f) an evaluation of the performance data relating to equivalent or similar devices, and the current state of the art; (g) reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMPF, and; (h) a detailed and adequately justified time schedule for PMPF activities, such as analysis of PMPF data and reporting, to be undertaken by the manufacturer. 6. The manufacturer shall analyse the findings of the PMPF and document the results in a PMPF evaluation report that shall update the performance evaluation report and be part of the technical documentation. 7. The conclusions of the PMPF evaluation report shall be taken into account for the performance evaluation referred to in Article 56 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMPF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them. 8. If PMPF is not deemed appropriate for a specific device then a justification shall be provided and documented within the performance evaluation report. ANNEX XIV INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES CHAPTER I DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES For devices intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects of the studies, the sponsor shall draw up and submit the application in accordance with Article 58 accompanied by the following documents: 1. Application form The application form shall be duly filled in, containing the following information: 1.1. name, address and contact details of the sponsor and, if applicable, name, address and contact details of its contact person or legal representative in accordance with Article 58(4) established in the Union; 1.2. if different from those in Section 1.1, name, address and contact details of the manufacturer of the device intended for performance evaluation and, if applicable, of its authorised representative; 1.3. title of the performance study; 1.4. single identification number in accordance with Article 66(1); 1.5. status of the performance study, such as. the first submission, resubmission, significant amendment; 1.6. details and/ or reference to the performance study plan, such as including details of the design phase of the performance study; 1.7. if the application is a resubmission with regard to a device for which an application has been already submitted, the date or dates and reference number or numbers of the earlier application or in the case of significant amendment, reference to the original application. The sponsor shall identify all of the changes from the previous application together with a rationale for those changes, in particular, whether any changes have been made to address conclusions of previous competent authority or ethics committee reviews; 1.8. if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial; 1.9. identification of the Member States and third countries in which the clinical performance study is to be conducted as part of a multicentre or multinational study at the time of application; 1.10. brief description of the device for performance study, its classification and other information necessary for the identification of the device and device type; 1.11. summary of the performance study plan; 1.12. if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device; 1.13. evidence from the sponsor that the clinical investigator and the investigational site are capable of conducting the clinical performance study in accordance with the performance study plan; 1.14. details of the anticipated start date and duration of the performance study; 1.15. details to identify the notified body, if already involved at the stage of application for the performance study; 1.16. confirmation that the sponsor is aware that the competent authority may contact the ethics committee that is assessing or has assessed the application; 1.17. the statement referred to in Section 4.1. 2. Investigator's brochure The investigator's brochure (IB) shall contain the information on the device for performance study that is relevant for the study and available at the time of application. Any updates to the IB or other relevant information that is newly available shall be brought to the attention of the investigators in a timely manner. The IB shall be clearly identified and contain in particular the following information: 2.1. Identification and description of the device, including information on the intended purpose, the risk classification and applicable classification rule pursuant to Annex VIII, design and manufacturing of the device and reference to previous and similar generations of the device. 2.2. Manufacturer's instructions for installation, maintenance, maintaining hygiene standards and for use, including storage and handling requirements, as well as, to the extent that such information is available, information to be placed the label, and instructions for use to be provided with the device when placed on the market. In addition, information relating to any relevant training required. 2.3. Analytical performance. 2.4. Existing clinical data, in particular: — from relevant peer-reviewed scientific literature and available consensus expert opinions or positions from relevant professional associations relating to the safety, performance, clinical benefits to patients, design characteristics, scientific validity, clinical performance and intended purpose of the device and/or of equivalent or similar devices; — other relevant clinical data available relating to the safety, scientific validity, clinical performance, clinical benefits to patients, design characteristics and intended purpose of similar devices, including details of their similarities and differences with the device in question. 2.5. Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks and warnings. 2.6. In the case of devices that include tissues, cells and substances of human, animal or microbial origins detailed information on the tissues, cells and substances, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to those tissues, cells and substances. 2.7. A list detailing the fulfilment of the relevant general safety and performance requirements set out in Annex I, including the standards and CS applied, in full or in part, as well as a description of the solutions for fulfilling the relevant general safety and performance requirements, in so far as those standards and CS have not or have only been partly fulfilled or are lacking. 2.8. A detailed description of the clinical procedures and diagnostic tests used in the course of the performance study and in particular information on any deviation from normal clinical practice. 3. Performance study plan as referred to in Sections 2 and 3 of Annex XIII. 4. Other information 4.1. A signed statement by the natural or legal person responsible for the manufacture of the device for performance study that the device in question conforms to the general safety and performance requirements laid down in Annex I apart from the aspects covered by the clinical performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject. 4.2. Where applicable according to national law, a copy of the opinion or opinions of the ethics committee or committees concerned. Where under national law the opinion or opinions of the ethics committee or committees is not required at the time of the submission of the application, a copy of the opinion or opinions shall be submitted as soon as available. 4.3. Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article 65 and the corresponding national law. 4.4. Documents to be used to obtain informed consent, including the patient information sheet and the informed consent document. 4.5 Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data, in particular: — organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure, dissemination, alteration or loss of information and personal data processed; — a description of measures that will be implemented to ensure confidentiality of records and personal data of subjects; — a description of measures that will be implemented in case of a data security breach in order to mitigate the possible adverse effects. 4.6. Full details of the available technical documentation, for example detailed risk analysis/management documentation or specific test reports shall be submitted to the competent authority reviewing an application upon request. CHAPTER II OTHER OBLIGATIONS OF THE SPONSOR 1. The sponsor shall undertake to keep available for the competent national authorities any documentation necessary to provide evidence for the documentation referred to in Chapter I of this Annex. If the sponsor is not the natural or legal person responsible for the manufacture of the device intended for performance study, that obligation may be fulfilled by that person on behalf of the sponsor. 2. The sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 76(2) are reported by the investigator or investigators to the sponsor in a timely manner. 3. The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clinical performance study with the device in question has ended, or, in the event that the device is subsequently placed on the market, for at least 10 years after the last device has been placed on the market. Each Member State shall require that the documentation referred to in this Annex is kept at the disposal of the competent authorities for the period indicated in the first subparagraph in case the sponsor, or his contact person, established within its territory, goes bankrupt or ceases its activity prior to the end of this period. 4. The sponsor shall appoint a monitor that is independent of the investigation site to ensure that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the principles of good clinical practice and this Regulation. 5. The sponsor shall complete the follow-up of investigation subjects. ANNEX XV CORRELATION TABLE Directive 98/79/EC This Regulation Article 1(1) Article 1(1) Article 1(2) Article 2 Article 1(3) points (54) and (55) of Article 2 Article 1(4) — Article 1(5) Article 5(4) and (5) Article 1(6) Article 1(9) Article 1(7) Article 1(5) Article 2 Article 5(1) Article 3 Article 5(2) Article 4(1) Article 21 Article 4(2) Article 19(1) and (2) Article 4(3) Article 19(3) Article 4(4) Article 10(10) Article 4(5) Article 18(6) Article 5(1) Article 8(1) Article 5(2) — Article 5(3) Article 9 Article 6 — Article 7 Article 107 Article 8 Articles 89 and 92 Article 9(1) first subparagraph Article 48(10) first subparagraph Article 9(1) second subparagraph Article 48(3) second subparagraph, Article 48(7) second subparagraph and Article 48(9) second subparagraph Article 9(2) Article 48(3) to (6) Article 9(3) Article 48(3) to (9) Article 9(4) Article 5(6) Article 9(5) — Article 9(6) Article 11(3) and (4) Article 9(7) Article 10(7) Article 9(8) Article 49(1) Article 9(9) Article 49(4) Article 9(10) Article 51(2) Article 9(11) Article 48(12) Article 9(12) Article 54(1) Article 9(13) Article 48(2) Article 10(1) and (2), second sentence of Article 10(3) and Article 10(4) Articles 26(3), 27 and 28 Article 10(3), first sentence Article 11(1) Article 11(1) Articles 82(1) and 84(2) Article 11(2) Article 82(10) and Article 82(11) first subparagraph Article 11(3) Article 84(7) Article 11(4) — Article 11(5) Article 86 Article 12 Article 30 Article 13 Article 93 Article 14(1)(a) — Article 14(1)(b) Article 47(3) and (6) Article 14(2) — Article 14(3) — Article 15(1) Article 38 and Article 39 Article 15(2) Article 32 Article 15(3) Article 40(2) and (4) Article 15(4) — Article 15(5) Article 51(5) Article 15(6) Article 51(4) Article 15(7) Article 34(2) and Article 40(2) Article 16 Article 18 Article 17 Articles 89 to 92 Article 18 Article 94 Article 19 Article 102 Article 20 Article 97 Article 21 — Article 22 — Article 23 — Article 24 —

Ensuring the safety and performance of in vitro diagnostic medical devices Ensuring the safety and performance of in vitro diagnostic medical devices SUMMARY OF: Regulation (EU) 2017/746 on in vitro diagnostic medical devices WHAT IS THE AIM OF THE REGULATION? It updates the rules on placing on the EU market, making available and putting into service in vitro diagnostic (IVD) medical devices * for human use and their accessories. It also contains rules on the conduct of performance studies * that are carried out in the EU concerning IVD medical devices (or accessories). It aims to improve patient safety by introducing stricter procedures for conformity assessment (to ensure that unsafe or non-compliant devices do not end up on the market) and post-market surveillance. KEY POINTS Scope It covers IVD medical devices for human use and their accessories. However, devices manufactured and used in the same healthcare centre are exempted from the rules laid down by this regulation, other than the relevant general safety and performance requirements, so long as a number of conditions are fulfilled. Classification system The classification system for IVD medical devices has been adapted to the rapid scientific progress in the field and to the international guidance. They are classified according to their intended purpose and their inherent risks (classes A, B, C and D — for more details, see the regulation’s Annex VIII). Notified bodies The regulation tightens the rules concerning how the independent notified bodies — which assess the conformity of medium- and high-risk medical devices before they are placed on the market — are designated, organised and monitored. These bodies have to meet the same high-quality standards throughout the EU and must have the required staff to successfully perform their conformity assessment tasks. On-site inspections of manufacturers, of which some are unannounced, must be carried out. Clinical data The regulation specifies what is required in the data collection of performance studies on IVD medical devices. These have been aligned with those applicable for clinical trials on medicinal products. These include rules on informed consent and protecting vulnerable subjects (e.g. people under the age of 18, pregnant women or the incapacitated). Performance studies conducted in more than one EU country will be subject to a coordinated assessment. Manufacturers’ obligations Manufacturers have clearer and more stringent obligations to monitor the quality, performance and safety of devices. They are required to have measures in place that correspond to the level of risk, type of device and size of company. They must ensure they have sufficient financial coverage with respect to their potential liability under the product liability directive as well as quality management and post-market surveillance systems. In the event of damages due to defective devices, a manufacturer’s authorised representative is jointly and severally liable. Traceability The regulation introduces a system for registering devices and manufacturers, importers and authorised representatives to ensure the traceability of devices throughout the supply chain by means of a unique device identification system. This will ensure that, should problems arise, measures can be taken rapidly. High-risk devices In the event of the first certification for class D IVD devices, and when common specifications are not available, designated reference laboratories will check the performance claimed by their manufacturers and an expert panel will be consulted on innovative devices of the same class. Although the notified body is not bound by the panel’s opinion, it has to provide a justification for not following it. Nevertheless, the notified body shall not deliver this first certificate if the scientific opinion of the EU reference laboratory is negative. Genetic counselling Patients tested with a genetic test must be provided with all relevant information on its nature, significance and implications. They must be given appropriate access to counselling in cases where a test provides information on the genetic predisposition for medical conditions and/or diseases which are generally considered to be untreatable. Incident reporting In addition to the obligation for manufacturers to report serious incidents (resulting in death or a serious deterioration in a person’s health) and trends in non-serious incidents (for example, side-effects from the use of a device), the regulation introduces the obligation for EU countries to encourage and enable healthcare professionals, users and patients to report suspected incidents at national level. Market surveillance Competent EU authorities are responsible for ensuring that any unsafe device is withdrawn from the market. Eudamed A centralised database, called the European Databank on Medical Devices (Eudamed) will be developed to provide EU countries, businesses, patients, healthcare professionals and the public with information on medical devices available in the EU. Repeal of existing legislation — Directive 98/79/EC and Commission Decision 2010/227/EU The regulation repeals Directive 98/79/EC and Decision 2010/227/EU from 26 May 2022, with some exceptions laid down in Article 112. FROM WHEN DOES THE REGULATION APPLY? It entered into force on 25 May 2017 and applies from 26 May 2022. Dates of application for some of the regulation’s articles vary and are detailed in Articles 110 and 113. BACKGROUND This regulation is one of 2 adopted by the EU to overhaul its laws on medical devices. The second regulation (Regulation (EU) 2017/745) concerns medical devices. For more information, see: Medical devices (European Commission).Following the COVID-19 outbreak and introducing measures to cope with the impact of the crisis, the European Commission adopted:Communication from the Commission — Guidelines on COVID-19 in vitro diagnostic tests and their performance KEY TERMS In vitro diagnostic medical devices: term covering a wide variety of devices used for providing information on: (a) a physiological or pathological process or state; (b) a congenital physical or mental impairment; (c) the predisposition to a medical condition or disease; (d) the safety and compatibility between the materials used and the specimens of the body intended to be used; (e) treatment response or reactions; (f) defining or monitoring therapeutic measures. Examples range from self-tests for pregnancy through to tests for highly transmissible substances using specimens taken from the human body. Performance studies: studies that demonstrate that an IVD medical device complies with the necessary regulatory requirements through conformity assessment procedures. MAIN DOCUMENT Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, pp. 176-332) RELATED DOCUMENTS Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, pp. 1-175) Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, pp. 45-48) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, pp. 1-37) Successive amendments to Directive 98/79/EC have been incorporated into the original text. This consolidated version is of documentary value only. last update 10.06.2020

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14.11.2019 EN Official Journal of the European Union L 295/1 REGULATION (EU) 2019/1896 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 77(2)(b) and (d) and Article 79(2)(c) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The objective of Union policy in the field of external border management is to develop and implement European integrated border management at national and Union level, which is a necessary corollary to the free movement of persons within the Union and is a fundamental component of an area of freedom, security and justice. European integrated border management is central to improving migration management. The aim is to manage the crossing of the external borders efficiently and address migratory challenges and potential future threats at those borders, thereby contributing to addressing serious crime with a cross-border dimension and ensuring a high level of internal security within the Union. At the same time, it is necessary to act in full respect for fundamental rights and in a manner that safeguards the free movement of persons within the Union. (2) The European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union was established by Council Regulation (EC) No 2007/2004 (4). Since taking up its responsibilities on 1 May 2005, it has been successful in assisting Member States with implementing the operational aspects of external border management through joint operations and rapid border interventions, risk analysis, information exchange, relations with third countries and the return of returnees. (3) The European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union has been renamed the European Border and Coast Guard Agency (the ‘Agency’), commonly referred to as Frontex, and its tasks have been expanded with full continuity in all its activities and procedures. The key roles of the Agency should be: to establish a technical and operational strategy as part of the implementation of the multiannual strategic policy cycle for European integrated border management; to oversee the effective functioning of border control at the external borders; to carry out risk analysis and vulnerability assessments; to provide increased technical and operational assistance to Member States and third countries through joint operations and rapid border interventions; to ensure the practical execution of measures in a situation requiring urgent action at the external borders; to provide technical and operational assistance in the support of search and rescue operations for persons in distress at sea; and to organise, coordinate and conduct return operations and return interventions. (4) Since the beginning of the migratory crisis in 2015, the Commission has taken up important initiatives and has proposed a series of measures with a view to strengthening the protection of the external borders and restoring the normal functioning of the Schengen area. A proposal for significantly enhancing the mandate of the European Agency for the Management of Operational Cooperation at the External Borders was presented in December 2015 and negotiated swiftly in 2016. The resulting regulation, Regulation (EU) 2016/1624 of the European Parliament and of the Council (5), entered into force on 6 October 2016. (5) However, the Union framework in the areas of external border control, return, combating cross-border crime, and asylum still needs to be further improved. To that end, and to further underpin the current and future envisaged operational efforts, the European Border and Coast Guard should be reformed by giving the Agency a stronger mandate and, in particular, by providing it with the necessary capabilities in the form of a European Border and Coast Guard standing corps (the ‘standing corps’). The standing corps should gradually but swiftly reach the strategic target of having a capacity of 10 000 operational staff, as set out in Annex I, with executive powers, where applicable, to effectively support Member States on the ground in their efforts to protect the external borders, to fight cross-border crime and to significantly step up the effective and sustainable return of irregular migrants. Such a capacity of 10 000 operational staff represents the maximum available capacity required to effectively address existing and future operational needs for border and return operations in the Union and third countries, including a rapid reaction capacity to face future crises. (6) The Commission should carry out a review of the overall number and composition of the standing corps, including the size of individual Member States' contributions thereto, as well as of its training, expertise and professionalism. By March 2024, the Commission should, where necessary, submit appropriate proposals to amend Annexes I, II, III and IV. Where the Commission does not present a proposal, it should explain the reason therefor. (7) The implementation of this Regulation, in particular the establishment of the standing corps, including after the Commission's review of the standing corps, should be subject to the multiannual financial framework. (8) In its conclusions of 28 June 2018, the European Council called for further strengthening of the supportive role of the Agency, including in cooperation with third countries, through increased resources and an enhanced mandate, with a view to ensuring effective external border control and significantly stepping up the effective return of irregular migrants. (9) It is necessary to monitor the crossing of the external borders efficiently, to address migratory challenges and potential future threats at the external borders, to ensure a high level of internal security within the Union, to safeguard the functioning of the Schengen area and to respect the overarching principle of solidarity. Those actions and objectives should be accompanied by the proactive management of migration, including the necessary measures in third countries. To that end, it is necessary to consolidate the European Border and Coast Guard and to further expand the mandate of the Agency. (10) When implementing European integrated border management, coherence with other policy objectives should be ensured. (11) European integrated border management, based on the four-tier access control model, comprises measures in third countries, such as under the common visa policy, measures with neighbouring third countries, border control measures at the external borders, risk analysis and measures within the Schengen area and return. (12) European integrated border management should be implemented as a shared responsibility of the Agency and the national authorities responsible for border management, including coast guards to the extent that they carry out maritime border surveillance operations and any other border control tasks, as well as the national authorities responsible for return. While Member States retain the primary responsibility for the management of their external borders in their interest and in the interest of all Member States and are responsible for issuing return decisions, the Agency should support the application of Union measures relating to the management of the external borders and return by reinforcing, assessing and coordinating the actions of the Member States which implement those measures. The activities of the Agency should complement the efforts of the Member States. (13) To ensure the effective implementation of European integrated border management and increase the efficiency of Union return policy, a European Border and Coast Guard should be established. It should be provided with the requisite financial and human resources and equipment. The European Border and Coast Guard should be composed of the Agency and the national authorities responsible for border management, including coast guards to the extent that they carry out border control tasks, as well as the national authorities responsible for return. As such it will rely upon the common use of information, capabilities and systems at national level and the response of the Agency at Union level. (14) European integrated border management does not alter the respective competences of the Commission and the Member States in the customs area, in particular regarding controls, risk management and the exchange of information. (15) The development of policy and law on external border control and return, including the development of a multiannual strategic policy for European integrated border management, remains a responsibility of the Union institutions. Close coordination between the Agency and those institutions should be guaranteed. (16) The effective implementation of European integrated border management by the European Border and Coast Guard should be ensured by means of a multiannual strategic policy cycle. The multiannual cycle should set out an integrated, unified and continuous process for providing strategic guidelines to all the relevant actors at Union level and at national level in the area of border management and return so that those actors are able to implement European integrated border management in a coherent manner. It should also address all relevant interactions of the European Border and Coast Guard with the Commission and other Union institutions, bodies, offices and agencies, and cooperation with other relevant partners, including third countries and third parties as appropriate. (17) European integrated border management requires integrated planning between the Member States and the Agency for border and return operations in order to prepare responses to challenges at the external borders, for contingency planning and for coordinating the long-term development of capabilities both in terms of recruitment and training and in terms of the acquisition and development of equipment. (18) The Agency should develop technical standards for information exchange as provided for in this Regulation. In addition, for the effective implementation of Regulation (EU) 2016/399 of the European Parliament and of the Council (6), common minimum standards for external border surveillance should be developed. To that end, the Agency should be able to contribute to the development of common minimum standards in line with the respective competences of the Member States and the Commission. Those common minimum standards should be developed taking into account the type of borders, the impact levels attributed by the Agency to each external border section and other factors such as geographical particularities. When developing those common minimum standards, possible limitations deriving from national law should be taken into account. (19) The technical standards for information systems and software applications should be aligned with the standards used by the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) for other IT systems in the area of freedom, security and justice. (20) The implementation of this Regulation does not affect the division of competence between the Union and the Member States or the obligations of Member States under the United Nations Convention on the Law of the Sea, the International Convention for the Safety of Life at Sea, the International Convention on Maritime Search and Rescue, the United Nations Convention against Transnational Organized Crime and its Protocol against the Smuggling of Migrants by Land, Sea and Air, the 1951 Convention relating to the Status of Refugees, the 1967 Protocol thereto, the European Convention for the Protection of Human Rights and Fundamental Freedoms, the United Nations Convention relating to the Status of Stateless Persons and other relevant international instruments. (21) The implementation of this Regulation does not affect Regulation (EU) No 656/2014 of the European Parliament and of the Council (7). Sea operations should be carried out in a way that, in all instances, ensures the safety of the persons intercepted or rescued, the safety of the units that take part in the sea operation in question and the safety of third parties. (22) The Agency should carry out its tasks in accordance with the principle of subsidiarity and without prejudice to the responsibilities of the Member States with regard to maintaining law and order and safeguarding internal security. (23) The Agency should carry out its tasks without prejudice to the competence of the Member States as regards defence. (24) The extended tasks and competence of the Agency should be balanced with strengthened fundamental rights safeguards and increased accountability and liability, in particular in terms of the exercise of executive powers by the statutory staff. (25) The Agency relies on the cooperation of Member States to be able to perform its tasks effectively. In that respect, it is important for the Agency and the Member States to act in good faith and to exchange accurate information in a timely manner. No Member State should be obliged to supply information the disclosure of which it considers contrary to the essential interests of its security. (26) Member States should also, in their own interest and in the interest of the other Member States, contribute relevant data necessary for the activities carried out by the Agency, including for the purposes of situational awareness, risk analysis, vulnerability assessments and integrated planning. Equally, they should ensure that the data are accurate and up-to-date and are obtained and entered lawfully. Where those data include personal data, Union law on data protection should apply in full. (27) The communication network established under this Regulation should be based on and replace the EUROSUR communication network developed in the framework of Regulation (EU) No 1052/2013 of the European Parliament and of the Council (8). The communication network established under this Regulation should be used for all secured information exchanges within the European Border and Coast Guard. The level of accreditation of the communication network should be increased to the classification level of CONFIDENTIEL UE/EU CONFIDENTIAL in order to improve information assurance between the Member States and with the Agency. (28) EUROSUR is necessary for the European Border and Coast Guard to be able to provide a framework for the exchange of information and the operational cooperation between Member States' national authorities and with the Agency. EUROSUR provides national authorities and the Agency with the infrastructure and tools needed to improve their situational awareness and to increase reaction capability at the external borders for the purpose of detecting, preventing and combating illegal immigration and cross-border crime, thereby contributing to saving the lives of migrants and ensuring their protection. (29) Member States should establish national coordination centres to improve the exchange of information and cooperation between Member States and with the Agency with respect to border surveillance and the carrying out of border checks. It is essential for the proper functioning of EUROSUR that all national authorities with a responsibility for external border surveillance under national law cooperate via national coordination centres. (30) The role of the national coordination centre to coordinate and exchange information among all authorities with a responsibility for external border control at national level is without prejudice to the competence established at national level with regard to planning and implementing border control. (31) This Regulation should not hinder Member States from also making their national coordination centres responsible for coordinating the exchange of information and for cooperation with regard to other components of European integrated border management. (32) The quality of the information exchanged between the Member States and the Agency and the timeliness of the exchange of such information are prerequisites for the proper functioning of European integrated border management. Building on the success of EUROSUR, that quality should be ensured through standardisation, the automation of the information exchange across networks and systems, information assurance and control of the quality of the data and information transmitted. (33) The Agency should provide the necessary assistance for the development and operation of EUROSUR, including the interoperability of systems, in particular by establishing, maintaining and coordinating EUROSUR. (34) EUROSUR should provide an exhaustive situational picture not only at the external borders but also within the Schengen area and in the pre-frontier area. It should cover land, sea and air border surveillance and border checks. The provision of situational awareness within the Schengen area should not lead to operational activities of the Agency at the internal borders of the Member States. (35) Air border surveillance should be an element of border management since both commercial and private flights and remotely piloted aircraft systems are used for illegal activities related to immigration and cross-border crime. Air border surveillance aims to detect and monitor such suspicious flights crossing or intending to cross the external borders and to perform related risk analysis with a view to triggering reaction capabilities by the competent authorities of the Union and the Member States. For that purpose, inter-agency cooperation at Union level should be promoted between the Agency, the Network Manager of the European Air Traffic Management Network (EATMN) and the European Union Aviation Safety Agency (EASA). Where relevant, Member States should be able to receive information on suspicious external flights and react accordingly. The Agency should monitor and support research and innovation activities in that area. (36) The reporting of events related to unauthorised secondary movements in EUROSUR will contribute to the monitoring by the Agency of migratory flows towards and within the Union for the purpose of risk analysis and situational awareness. The implementing act laying down the details of the information layers of the situational pictures and the rules for the establishment of specific situational pictures should further define the type of reporting to best meet this objective. (37) The EUROSUR fusion services supplied by the Agency should be based on the common application of surveillance tools and inter-agency cooperation at Union level, including the provision of Copernicus security services. EUROSUR fusion services should provide the Member States and the Agency with value-added information services related to European integrated border management. EUROSUR fusion services should be expanded to support border checks, air border surveillance and the monitoring of migration flows. (38) The practice of travelling in small and unseaworthy vessels has dramatically increased the number of migrants drowning at the southern maritime external borders. EUROSUR should considerably improve the operational and technical ability of the Agency and the Member States to detect such small vessels and to improve the reaction capability of the Member States, thereby contributing to reducing the loss of lives of migrants, including in the framework of search and rescue operations. (39) It is recognised in this Regulation that migratory routes are also taken by persons in need of international protection. (40) The Agency should prepare general and tailored risk analyses based on a common integrated risk analysis model, to be applied by the Agency itself and by Member States. The Agency should, based also on information provided by Member States, provide adequate information covering all aspects relevant to European integrated border management, especially border control, return, the phenomenon of unauthorised secondary movements of third-country nationals within the Union in terms of trends, volume and routes, prevention of cross-border crime including facilitation of unauthorised border crossings, trafficking in human beings, terrorism and threats of a hybrid nature, as well as the situation in relevant third countries, so as to allow for appropriate measures to be taken or to tackle identified threats and risks with a view to improving the integrated management of the external borders. (41) Given its activities at the external borders, the Agency should contribute to preventing and detecting cross-border crime, such as migrant smuggling, trafficking in human beings and terrorism, where it is appropriate for it to act and where it has obtained relevant information through its activities. It should coordinate its activities with Europol, which is the agency responsible for supporting and strengthening Member States' actions and their cooperation in preventing and combating serious crime affecting two or more Member States. The cross-border dimension is characterised by crimes that are directly linked to unauthorised crossings of the external borders, including trafficking in human beings or smuggling of migrants. In accordance with Council Directive 2002/90/EC (9), Member States are able to decide not to impose sanctions where the aim of the behaviour is to provide humanitarian assistance to migrants. (42) In a spirit of shared responsibility, the role of the Agency should be to monitor regularly the management of the external borders, including the respect for fundamental rights in the border management and return activities of the Agency. The Agency should ensure proper and effective monitoring not only through situational awareness and risk analysis, but also through the presence of experts from its own staff in Member States. The Agency should therefore be able to deploy liaison officers to Member States for a period of time during which the liaison officer reports to the executive director. The reports of the liaison officers should form part of the vulnerability assessment. (43) The Agency should carry out a vulnerability assessment based on objective criteria to assess the capacity and readiness of the Member States to face challenges at their external borders and to contribute to the standing corps and technical equipment pool. The vulnerability assessment should include an assessment of the equipment, infrastructure, staff, budget and financial resources of Member States as well as their contingency plans to address possible crises at the external borders. Member States should take measures to address any deficiencies identified in that assessment. The executive director should identify the measures to be taken and recommend them to the Member State concerned. The executive director should also set a time limit within which those measures should be taken and closely monitor their timely implementation. Where the necessary measures are not taken within the set time limit, the matter should be referred to the management board for a further decision. (44) If the Agency is not provided with the accurate and timely information necessary for carrying out a vulnerability assessment, it should be able to take that fact into account when performing the vulnerability assessment, unless duly justified reasons are provided for withholding the data. (45) The vulnerability assessment and the Schengen evaluation mechanism established by Council Regulation (EU) No 1053/2013 (10) are two complementary mechanisms for guaranteeing Union quality control on the proper functioning of the Schengen area and ensuring constant preparedness at both Union and national levels to respond to any challenges at the external borders. While the Schengen evaluation mechanism is the primary method for evaluating the implementation of and compliance with Union law in the Member States, the synergies between the vulnerability assessment and the Schengen evaluation mechanism should be maximised with a view to establishing an improved situational picture of the functioning of the Schengen area, avoiding, to the extent possible, duplication of efforts on the Member States' side, and ensuring the better-coordinated use of the relevant Union financial instruments supporting the management of the external borders. For that purpose, the regular exchange of information between the Agency and the Commission on the results of both mechanisms should be established. (46) Given that the Member States establish border sections, to which the Agency attributes impact levels, and that the reaction capabilities of the Member States and of the Agency should be linked to those impact levels, a fourth impact level — the critical impact level — should be established to be attributed to a border section on a temporary basis where the Schengen area is at risk and where the Agency should intervene. (47) Where a high or critical impact level is attributed to a maritime border section due to an increase of illegal immigration, the Member States concerned should take that increase into account for the planning and conducting of search and rescue operations since such a situation could generate an increase in requests for assistance for persons in distress at sea. (48) The Agency should organise appropriate technical and operational assistance to Member States in order to reinforce their capacity to implement their obligations with regard to external border control and to face challenges at the external borders resulting from an increased number of arrivals of irregular migrants or cross-border crime. Such assistance should be without prejudice to the relevant national authorities' competence to initiate criminal investigations. In that respect, the Agency should, either on its own initiative and with the agreement of the Member State concerned or at the request of that Member State, organise and coordinate joint operations for one or more Member States, deploy border management teams, migration management support teams and return teams (collectively referred to as ‘teams’) from the standing corps and provide the necessary technical equipment. (49) Where there is a specific and disproportionate challenge at the external borders, the Agency should, either on its own initiative and with the agreement of the Member State concerned or at the request of that Member State, organise and coordinate rapid border interventions and deploy both teams from the standing corps and technical equipment, including from the rapid reaction equipment pool. The rapid reaction equipment pool should contain a limited number of items of equipment needed for possible rapid border interventions. Rapid border interventions should provide reinforcement for a limited period of time in situations where an immediate response is required and where such an intervention would provide an effective response. To ensure that such intervention is effective, Member States should make staff that they second to the Agency, provide to the Agency for short-term deployment and deploy for the purposes of the reserve for rapid reaction available to form relevant teams and provide the necessary technical equipment. Where the crew deployed with the technical equipment of a Member State originates in that Member State, it should count as part of that Member State's contribution to the standing corps. The Agency and the Member State concerned should agree upon an operational plan. (50) Where a Member State faces specific and disproportionate migratory challenges at particular areas of its external borders characterised by large, inward, mixed migratory flows, the Member States should be able to rely on increased technical and operational reinforcements. Those reinforcements should be provided in hotspot areas by migration management support teams. Those teams should be composed of operational staff to be deployed from the standing corps and experts from the European Asylum Support Office (EASO), Europol and, where relevant, the European Union Agency for Fundamental Rights, other Union bodies, offices and agencies, and Member States. The Commission should ensure the necessary coordination of the assessment of needs submitted by Member States. The Agency should assist the Commission in the coordination among the different agencies on the ground. The Commission should, in cooperation with the host Member State and relevant Union agencies, establish the terms of cooperation at hotspot areas. The Commission should ensure the cooperation of the relevant agencies within their respective mandates and be responsible for coordinating the activities of the migration management support teams. (51) Member States should ensure that any authorities which are likely to receive applications for international protection, such as the police, border guards, immigration authorities and personnel of detention facilities, have the relevant information. They should also ensure that such authorities' personnel receive the necessary level of training which is appropriate to their tasks and responsibilities and instructions to inform applicants as to where and how applications for international protection may be lodged and instructions as to how to refer persons in a vulnerable situation to the appropriate referral mechanisms. (52) In its conclusions of 28 June 2018, the European Council reconfirmed the importance of relying on a comprehensive approach to migration and considered that migration is a challenge not only for one Member State but also for Europe as a whole. In that respect, it highlighted the importance for the Union of providing full support to ensure an orderly management of migration flows. (53) The Agency and EASO should cooperate closely in order to address effectively migratory challenges characterised by large inward mixed migratory flows, in particular at the external borders. In particular, the Agency and EASO should coordinate their activities and support Member States to facilitate procedures regarding international protection and the return procedure with regard to third-country nationals whose applications for international protection are rejected. The Agency and EASO should also cooperate in other common operational activities such as shared risk analysis, the collection of statistical data, training, and support to Member States in connection with contingency planning. (54) National authorities carrying out coast guard functions are responsible for a wide range of tasks, which may include maritime safety, security, search and rescue, border control, fisheries control, customs control, general law enforcement and environmental protection. The Agency, the European Fisheries Control Agency (EFCA) and the European Maritime Safety Agency (EMSA) should therefore strengthen their cooperation both with each other and with the national authorities carrying out coast guard functions to increase maritime situational awareness and to support coherent and cost-efficient action. Synergies between the various actors in the maritime environment should be in line with European integrated border management and maritime security strategies. (55) In hotspot areas, the Member States should cooperate with the relevant Union agencies, which should act within their respective mandates and powers, under the coordination of the Commission. The Commission, in cooperation with the relevant Union agencies, should ensure that activities in hotspot areas comply with relevant Union law and fundamental rights. (56) Where justified by the results of the vulnerability assessment or risk analysis or where a critical impact level has been temporarily attributed to one or more border sections, the executive director of the Agency should recommend to the Member State concerned to initiate and carry out joint operations or rapid border interventions. (57) Where external border control is rendered ineffective to such an extent that it risks jeopardising the functioning of the Schengen area, either because a Member State does not take the necessary measures in line with a vulnerability assessment or because a Member State facing specific and disproportionate challenges at the external borders has not requested sufficient support from the Agency or is not implementing such support, a unified, rapid and effective response should be delivered at Union level. For the purpose of mitigating these risks, and to ensure better coordination at Union level, the Commission should propose to the Council a decision that identifies the measures to be implemented by the Agency and requires the Member State concerned to cooperate with the Agency in the implementation of those measures. The implementing power to adopt such a decision should be conferred on the Council because of the potentially politically sensitive nature of the measures to be decided, which are likely to touch on national executive and enforcement powers. The Agency should then determine the actions to be taken for the practical execution of the measures indicated in the Council decision. The Agency should draw up an operational plan with the Member State concerned. The Member State concerned should facilitate the implementation of the Council decision and the operational plan by fulfilling, inter alia, its obligations as provided for in this Regulation. If a Member State does not comply with that Council decision within 30 days and does not cooperate with the Agency in the implementation of the measures contained in that decision, the Commission should be able to trigger the specific procedure provided for in Article 29 of Regulation (EU) 2016/399 to address exceptional circumstances putting the overall functioning of the area without internal border control at risk. (58) The standing corps should be composed of four categories of operational staff, namely statutory staff, staff seconded to the Agency by the Member States for a long term, staff provided by Member States for short-term deployments and staff forming part of the reserve for rapid reaction for rapid border interventions. Operational staff should consist of border guards, return escorts, return specialists, and other relevant staff. The standing corps should be deployed in the framework of teams. The actual number of operational staff deployed from the standing corps should depend on operational needs. (59) Operational staff deployed as members of the teams should have all the necessary powers to carry out border control and return tasks, including the tasks requiring executive powers, set out in relevant national law or in this Regulation. Where statutory staff exercise executive powers, the Agency should be liable for any damage caused. (60) Member States should contribute to the standing corps in accordance with Annex II for long-term secondments and Annex III for short-term deployments. The individual contributions of Member States should be established on the basis of the distribution key agreed during the negotiations in 2016 on Regulation (EU) 2016/1624 for the purposes of the rapid reaction pool and set out in Annex I to that Regulation. That distribution key should be proportionally adapted to the size of the standing corps. Those contributions should also be established in a proportionate way for the Schengen associated countries. (61) When selecting the numbers and profiles of staff to be indicated in the decision of the management board, the executive director should apply the principles of equal treatment and proportionality, in particular with regard to the national capabilities of Member States. (62) The exact timing for short-term deployments from the standing corps and for making available technical equipment co-financed under the specific actions of the Internal Security Fund or any other dedicated Union funding should be agreed between each Member State and the Agency through annual bilateral negotiations, taking into account capacity and proportionality. When requesting national contributions to the standing corps, the executive director should apply as a general rule the principles of proportionality and equal treatment of Member States with the aim of preventing situations that would substantially affect the discharge of national tasks in one Member State by requesting the deployment of the annual contributions of that Member State in one particular period of four months. Such arrangements should include the possibility for Member States to fulfil their obligations regarding deployment periods by means of non-consecutive periods. With regard to short-term deployments from the standing corps, Member States should also be able to fulfil their obligations for short-term deployment in a cumulative manner, by deploying more staff for shorter periods or by deploying the individual staff members for more than four months in accordance with the planning agreed through annual bilateral negotiations. (63) Without prejudice to the timely conclusion of the operational plan regarding sea operations, the Agency should provide participating Member States, at the earliest possible stage, with specific information on the relevant jurisdiction and applicable law, in particular on the prerogatives of the commanders of ships and aircraft, the conditions of the use of force and the imposition of restrictive or custodial measures. (64) The long-term development of human resources to secure the contributions of the Member States to the standing corps should be supported by a financial support system. For that purpose, it is appropriate to authorise the Agency to use the award of grants to the Member States without a call for proposals under financing not linked to costs subject to the fulfilment of the conditions set out in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (11). The financial support should enable Member States to hire and train additional staff to provide them with the necessary flexibility to comply with the mandatory contributions to the standing corps. The financial support system should take into account the time required for recruitment and training, and it should therefore be based on the N + 2 rule. The dedicated financing system should strike the right balance between the risks of irregularities and fraud and costs of control. This Regulation sets the essential conditions for triggering the financial support, namely the recruitment and training of the adequate number of border guards or other specialists corresponding to the number of officers seconded to the Agency for a long term or the effective deployment of officers during the Agency's operational activities for a consecutive or non-consecutive period of at least four months or on a pro-rata basis for deployments for a consecutive or a non-consecutive period of less than four months. Given the lack of relevant and comparable data on actual costs across Member States, the development of a cost-based financing scheme would be overly complex and would not address the need for a simple, fast, efficient and effective financing scheme. For the purpose of fixing the amount of such financing to different Member States, it is appropriate to use as a reference amount the annual salary of contractual agents in function group III, grade 8, step 1 of the institutions of the Union, adjusted by a corrective coefficient per Member State in line with the principle of sound financial management and in the spirit of equal treatment. When implementing such financial support, the Agency and Member States should ensure that the principles of co-financing and no double funding are complied with. (65) In order to alleviate the possible impact on the national services related to the recruitment of statutory staff for the standing corps, support should be provided to the relevant services of Member States to cover training investments for new personnel replacing such departing personnel. (66) In view of the deployment of the standing corps on the territories of third countries, the Agency should develop the capabilities for its own command and control structures as well as a procedure to ensure that the members of the teams can be held civilly and criminally liable. (67) In order to allow for effective deployments from the standing corps beginning on 1 January 2021, certain decisions and implementing measures should be taken and put in place as soon as possible. Therefore, the Agency, together with the Member States and the Commission, should engage in the preparation of such implementing measures and decisions for adoption by the management board. Such a preparatory process should encompass the relevant recruitment by the Agency and the Member States as referred to in this Regulation. (68) In order to ensure the continuity of the support for operational activities organised by the Agency, however, all deployments, including under the rapid reaction pool, to be made by 31 December 2020 should be planned and implemented in accordance with Regulation (EU) 2016/1624 and in accordance with the annual bilateral negotiations carried out in 2019. To that end, the relevant provisions of that Regulation should only be repealed with effect from 1 January 2021. (69) The Agency's workforce should consist of staff performing the tasks devoted to the Agency, either in the Agency's headquarters or as part of the standing corps. Statutory staff within the standing corps should primarily be deployed as members of the teams. It should be possible to recruit only a limited and clearly defined number of statutory staff to perform supportive functions for the establishment of the standing corps, in particular at headquarters. (70) To overcome the persistent gaps in the voluntary pooling of technical equipment from Member States, in particular as regards large-scale assets, the Agency should have its own necessary equipment to be deployed in joint operations or rapid border interventions or any other operational activities. Those assets should be authorised by the Member States as being on government service. While the Agency has been legally able to acquire or lease its own technical equipment since 2011, that possibility was significantly hindered by the lack of budgetary resources. (71) Consequently, in order to match the level of ambition underlying the establishment of the standing corps, the Commission earmarked a significant envelope under the 2021-2027 multiannual financial framework to allow the Agency to acquire, maintain and operate the necessary air, sea and land assets corresponding to its operational needs. While the acquisition of the necessary assets could be a lengthy process, especially for large assets, the Agency's own equipment should ultimately become the backbone of the operational deployments with additional contributions by Member States to be called upon in exceptional circumstances. The Agency's equipment should be largely operated by the Agency's technical crews that are part of the standing corps. In order to ensure the effective use of the proposed financial resources, the acquisition of the necessary assets should be based on a multiannual strategy decided as early as possible by the management board. It is necessary to ensure the sustainability of the Agency by means of future multiannual financial frameworks and to maintain comprehensive European integrated border management. (72) In the implementation of this Regulation, the Agency and the Member States should make the best possible use of existing capabilities in terms of human resources as well as technical equipment, both at Union and national level. (73) The long-term development of new capabilities within the European Border and Coast Guard should be coordinated between the Member States and the Agency in line with the multiannual strategic policy cycle for European integrated border management, taking into account the long duration of certain processes. That includes the recruitment and training of new border guards, which, during their career, could serve both in Member States and as part of the standing corps, the acquisition, maintenance and disposal of equipment, for which opportunities for interoperability and economies of scale should be sought, and the development of new equipment and related technologies, including through research. (74) The capability roadmap should converge the capability development plans of Member States and the multiannual planning of the Agency's resources to optimise long-term investment to best protect the external borders. (75) Taking into account the enhanced mandate of the Agency, the setting up of the standing corps and its strengthened presence on the ground at the external borders and its increased engagement in the field of return, it should be possible for the Agency to establish antenna offices situated at locations in the proximity of its significant operational activities for the duration of those activities, to act as an interface between the Agency and the host Member State, to deal with coordination and logistical and support tasks and to facilitate cooperation between the Agency and the host Member State. (76) In light of the fact that inter-agency cooperation forms part of European integrated border management, the Agency should closely cooperate with all relevant Union bodies, offices and agencies, in particular with Europol and EASO. Such cooperation should take place at the level of headquarters, in operational areas and, where relevant, at the level of antenna offices. (77) The Agency and the Member States, in particular their training academies, should cooperate closely with respect to the training of the standing corps, while ensuring that training programmes are harmonised and foster the common values enshrined in the Treaties. The Agency should be able, after obtaining the approval of the management board, to set up an Agency training centre to facilitate further the inclusion of a common European culture in the training provided. (78) The Agency should further develop common core curricula and adequate training tools for border management and return, including specific training on the protection of vulnerable persons, including children. It should also offer additional training courses and seminars related to integrated border management tasks, including for officers of the competent national bodies. The Agency should provide the members of the standing corps with specialised training relevant to their tasks and powers. That should include training on relevant Union and international law and on fundamental rights. The Agency should be authorised to organise training activities in cooperation with Member States and third countries on their territories. (79) The return of third-country nationals who do not fulfil or who no longer fulfil the conditions for entry, stay or residence in the Member States, in accordance with Directive 2008/115/EC of the European Parliament and of the Council (12), is an essential component of the comprehensive efforts to tackle illegal immigration and represents an important issue of substantial public interest. (80) The Agency should step up its assistance to Member States for returning third-country nationals, subject to Union return policy and in compliance with Directive 2008/115/EC. In particular, the Agency should coordinate and organise return operations from one or more Member States and organise and conduct return interventions to reinforce the return systems of Member States that require increased technical and operational assistance to comply with their obligation to return third-country nationals in accordance with that Directive. (81) The Agency should, in full respect for fundamental rights and without prejudice to the Member States' responsibility for issuing return decisions, provide technical and operational assistance to Member States in the return process, including in the identification of third-country nationals and in other pre-return and return-related activities of the Member States. In addition, the Agency should assist Member States in the acquisition of travel documents for return, in cooperation with the authorities of the relevant third countries. (82) The Agency should allow, subject to the agreement of the Member State concerned, the European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment of the Council of Europe to conduct visits to where it carries out return operations, within the framework of the monitoring mechanism established by the members of the Council of Europe under the European Convention for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment. (83) The assistance to Member States in carrying out return procedures should include the provision of practical information on third countries of return relevant for the implementation of this Regulation, such as the provision of contact details or other logistical information necessary for the smooth and dignified conduct of return operations. The assistance should also include the operation and maintenance of a platform for the exchange of data and information necessary for the Agency to provide technical and operational assistance in accordance with this Regulation. That platform should have a communication infrastructure enabling the automated transmission of statistical data by the Member States' return management systems. (84) The possible existence of an arrangement between a Member State and a third country does not absolve the Agency or the Member States from their obligations or liability under Union or international law, in particular as regards compliance with the principle of non-refoulement and the prohibition of torture and inhuman or degrading treatment. (85) Member States should be able to cooperate at operational level with other Member States or third countries at the external borders, including as regards military operations with a law enforcement purpose, to the extent that that cooperation is compatible with the actions of the Agency. (86) The Agency should improve the exchange of information and cooperation with other Union bodies, offices and agencies, such as Europol, EASO, EMSA, the European Union Satellite Centre, EASA and the Network Manager of the EATMN in order to make the best use of information, capabilities and systems which are already available at European level, such as Copernicus, the Union Earth observation and monitoring programme. (87) Cooperation with third countries is an important element of European integrated border management. It should serve to promote European border management and return standards, to exchange information and risk analysis, and to facilitate the implementation of returns with a view to increasing their efficiency and to supporting third countries in the area of border management and migration, including through the deployment of the standing corps where such support is required to protect external borders and the effective management of the Union's migration policy. (88) Where the Commission recommends that the Council authorise it to negotiate a status agreement with a third country, the Commission should assess the fundamental rights situation relevant to the areas covered by the status agreement in that third country and inform the European Parliament thereof. (89) Cooperation with third countries should take place in the framework of the external action of the Union and in line with the principles and objectives laid down in Article 21 of the Treaty on European Union (TEU). The Commission should ensure consistency between European integrated border management and other Union policies in the field of the Union's external action and, in particular, the Common Security and Defence Policy. The Commission should be assisted by the High Representative of the Union for Foreign Affairs and Security Policy. Such cooperation should take place with regard to, in particular, the activities of the Agency taking place on the territory of third countries or involving the officials of third countries in areas such as risk analysis, planning and conduct of operations, training, information exchange and cooperation. (90) In order to ensure that the information contained in EUROSUR is as complete and up to date as possible, in particular with regard to the situation in third countries, the Agency should cooperate with the authorities of third countries either in the framework of bilateral and multilateral agreements between the Member States and third countries, including regional networks, or through working arrangements concluded between the Agency and the relevant authorities of third countries. For those purposes, the European External Action Service and Union delegations and offices should provide all information that could be relevant for EUROSUR. (91) This Regulation includes provisions on cooperation with third countries because well-structured and permanent exchange of information and cooperation with such countries, including but not limited to neighbouring third countries, are key factors for achieving the objectives of European integrated border management. It is essential that any exchange of information and any cooperation between Member States and third countries take place in full compliance with fundamental rights. (92) The assistance to third countries should complement the Agency's support for Member States in the application of Union measures relating to the implementation of European integrated border management. (93) It should be possible for the bilateral and multilateral agreements concluded by Member States with third countries in the areas covered by European integrated border management to contain security sensitive information. Where notified to the Commission, such information should be handled by the Commission in accordance with the applicable security rules. (94) To establish a comprehensive situational picture and risk analysis covering the pre-frontier area, the Agency and the national coordination centres should collect information and coordinate with immigration liaison officers deployed in third countries by Member States, the Commission, the Agency or other Union bodies, offices and agencies. (95) The False and Authentic Documents Online (‘FADO’) system was established by Council Joint Action 98/700/JHA (13) within the General Secretariat of the Council enabling Member States' authorities to have at their disposal information on any new forgery methods that are detected and on the new genuine documents that are in circulation. (96) In its conclusions of 27 March 2017, the Council stated that the management of the FADO system is outdated and that a change of its legal basis is required in order to continue meeting the requirements of justice and home affairs policies. The Council also noted that synergies could be exploited in that regard using the Agency's expertise in the area of document fraud and the work the Agency has already been carrying out in the field. It is therefore intended that the Agency take over the administration and the operational and technical management of the FADO system from the General Secretariat of the Council as soon as the European Parliament and the Council have adopted the relevant legal act on the FADO system replacing Joint Action 98/700/JHA. (97) Prior to the adoption of the relevant legal act on the FADO system, it is desirable to ensure that the FADO system is fully operational until the transfer is effectively carried out and the existing data are transferred to the new system. The ownership of the existing data would then be transferred to the Agency. (98) Any processing of personal data by the Agency within the framework of this Regulation should be conducted in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (14). (99) Any processing of personal data by Member States within the framework of this Regulation should be conducted in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (15) or Directive (EU) 2016/680 of the European Parliament and of the Council (16), as applicable. (100) In the context of return, third-country nationals frequently do not hold any identification documents and do not cooperate as regards the establishment of their identity by withholding information or providing incorrect personal data. Given the particular policy need for expedient return procedures, it is necessary for the Agency to be able to restrict certain rights of data subjects so as to prevent the abuse of such rights from impeding the proper implementation of return procedures and the successful enforcement of return decisions by the Member States or from preventing the Agency from performing its tasks efficiently. In particular, the exercise of the right to the restriction of processing could significantly delay and obstruct the carrying out of the return operations. Furthermore, in some cases, the right of access by the third-country national could jeopardise a return operation by increasing the risk of absconding should the third-country national learn that the Agency is processing his or her data in the context of a planned return operation. The right to rectification could increase the risk that the third-country national in question will mislead the authorities by providing incorrect data. In order to enable the Agency to restrict certain rights of data subjects, it should be able to adopt internal rules on such restrictions. (101) In order to properly implement its tasks in the area of return, including by assisting Member States in the proper implementation of return procedures and the successful enforcement of return decisions, as well as to facilitate return operations, the Agency might need to transfer the personal data of returnees to third countries. The third countries of return are not often subject to adequacy decisions adopted by the Commission under Article 45 of Regulation (EU) 2016/679 or under Article 36 of Directive (EU) 2016/680, and have often not concluded or do not intend to conclude a readmission agreement with the Union or otherwise provide for appropriate safeguards within the meaning of Article 48 of Regulation (EU) 2018/1725 or within the meaning of the national provisions transposing Article 37 of Directive (EU) 2016/680. However, despite the extensive efforts of the Union in cooperating with the main countries of origin of illegally staying third-country nationals subject to an obligation to return, it is not always possible to ensure that such third countries systematically comply with the obligation established by international law to readmit their own nationals. Readmission agreements concluded or being negotiated by the Union or the Member States which provide for appropriate safeguards for personal data cover a limited number of such third countries. Where such agreements do not yet exist, personal data should be transferred by the Agency for the purposes of facilitating the return operations of the Union, provided that the conditions laid down in point (d) of Article 50(1) of Regulation (EU) 2018/1725 are met. (102) Any transfer of personal data by Member States to third countries should be carried out in accordance with Regulation (EU) 2016/679 and Directive (EU) 2016/680, as applicable. In the absence of readmission agreements, and as an exception to the requirement that adequacy decisions have been adopted or appropriate safeguards have been provided for, it should be possible for Member States to transfer personal data to the authorities of third countries for the purposes of implementing Union return policy. It should be possible to use the derogation for specific situations provided for in Article 49 of Regulation (EU) 2016/679 and Article 38 of Directive (EU) 2016/680, as applicable, subject to the conditions set out in those articles. (103) This Regulation respects the fundamental rights and observes the principles recognised by Articles 2 and 6 TEU and by the Charter of Fundamental Rights of the European Union (‘the Charter’), in particular respect for human dignity, the right to life, the prohibition of torture and inhuman or degrading treatment or punishment, the prohibition of trafficking in human beings, the right to liberty and security, the right to the protection of personal data, the right of access to documents, the right to asylum and to protection against removal and expulsion, non-refoulement, non-discrimination and the rights of the child. (104) This Regulation should establish a complaints mechanism for the Agency in cooperation with the fundamental rights officer, to safeguard the respect for fundamental rights in all the activities of the Agency. This should be an administrative mechanism whereby the fundamental rights officer should be responsible for handling complaints received by the Agency in accordance with the right to good administration. The fundamental rights officer should review the admissibility of a complaint, register admissible complaints, forward all registered complaints to the executive director, forward complaints concerning members of the teams to the home Member State, and register the follow-up by the Agency or that Member State. The mechanism should be effective, ensuring that complaints are properly followed up. The complaints mechanism should be without prejudice to access to administrative and judicial remedies and not constitute a requirement for seeking such remedies. Criminal investigations should be conducted by the Member States. In order to increase transparency and accountability, the Agency should report on the complaints mechanism in its annual report. The report should cover in particular the number of complaints it has received, the types of fundamental rights violations involved, the operations concerned and, where possible, the follow-up measures taken by the Agency and Member States. The fundamental rights officer should have access to all information concerning respect for fundamental rights in relation to all the activities of the Agency. The fundamental rights officer should be provided with the resources and staff necessary to enable him or her to effectively perform all his or her tasks in accordance with this Regulation. The staff provided to the fundamental rights officer should have the skills and seniority that correspond to the expansion of activities and powers of the Agency. (105) The Agency should be independent as regards technical and operational matters and have legal, administrative and financial autonomy. To that end, it is necessary and appropriate that it should be a Union body having legal personality and exercising the implementing powers that are conferred upon it by this Regulation. (106) The Commission and the Member States should be represented within a management board to exercise oversight over the Agency. The management board should, where possible, consist of the operational heads of the national services responsible for border management or their representatives. The parties represented in the management board should make efforts to limit turnover of their representatives in order to ensure continuity of the management board's work. The management board should be entrusted with the necessary powers to establish the Agency's budget, verify its execution, adopt appropriate financial rules, establish transparent working procedures for decision-making by the Agency and appoint the executive director and three deputy executive directors, each of whom should be assigned responsibilities in a certain field of competence of the Agency, such as managing the standing corps, overseeing the Agency's tasks regarding returns or managing the Agency's involvement in large-scale IT systems. The Agency should be governed and operated taking into account the principles of the common approach on Union decentralised agencies adopted on 19 July 2012 by the European Parliament, the Council and the Commission. (107) Given the involvement of the European Parliament in the matters governed by this Regulation, the chairperson of the management board should be able to invite an expert of the European Parliament to attend the meetings of the management board. (108) Each year, the management board should prepare a single programming document. When preparing that document, the management board should take into account the recommendations of the Interinstitutional Working Group on decentralised agencies' resources. (109) In order to guarantee the autonomy of the Agency, it should be granted a stand-alone budget with a revenue which comes mostly from a contribution from the Union. The Agency's budget should be prepared in accordance with the principle of performance-based budgeting, taking into account the Agency's objectives and the expected results of its tasks. The Union budgetary procedure should be applicable as far as the Union contribution and any other subsidies chargeable to the general budget of the Union are concerned. The auditing of accounts should be undertaken by the Court of Auditors. In exceptional situations where the available budget is deemed insufficient and the budgetary procedure does not allow an adequate response to fast-developing situations, the Agency should have the possibility of receiving grants from Union funds to fulfil its tasks. (110) The executive director, in his or her capacity as an authorising officer, should assess the financial risks related to the Agency's activities on a regular basis and take the necessary mitigating measures in accordance with the financial framework applicable to the Agency and inform the management board accordingly. (111) The Agency is expected to face challenging circumstances in the coming years as regards fulfilling exceptional needs for recruiting and retaining qualified staff from the broadest possible geographical basis. (112) In the spirit of shared responsibility, the Agency should require the staff it employs, in particular the statutory staff of the standing corps, including statutory staff deployed in operational activities, to possess the same level of training, special expertise and professionalism as staff seconded or employed by the Member States. Therefore, the Agency should review and evaluate whether its statutory staff conduct themselves properly in operational activities in the field of border control and return. (113) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (17) should apply without restriction to the Agency, which should accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-Fraud Office (OLAF) (18). (114) In accordance with Council Regulation (EU) 2017/1939 (19), the European Public Prosecutor's Office should be able to investigate and prosecute fraud and other criminal offences affecting the Union's financial interests as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (20). (115) Regulation (EC) No 1049/2001 of the European Parliament and of the Council (21) should apply to the Agency. The Agency should be as transparent as possible about its activities, without jeopardising the attainment of the objective of its operations. It should make public the information about all of its activities. It should likewise ensure that the public and any interested party are rapidly given information with regard to its work. (116) The Agency should also report on its activities to the European Parliament, to the Council and to the Commission to the fullest extent. (117) The Commission should carry out an evaluation of this Regulation. That evaluation should assess, inter alia, the attractiveness of the Agency as an employer for the recruitment of statutory staff with a view to ensuring the quality of the candidates and geographical balance. (118) The external borders referred to in this Regulation are those to which the provisions of Title II of Regulation (EU) 2016/399 apply, which includes the external borders of Schengen Member States in accordance with Protocol No 19 on the Schengen acquis integrated into the framework of the European Union, annexed to the TEU and to the Treaty on the Functioning of the European Union (TFEU). (119) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (22). (120) Since the objectives of this Regulation, namely the development and implementation of a system of integrated management of the external borders to ensure the proper functioning of the Schengen area, cannot be sufficiently achieved by the Member States acting in an uncoordinated manner but can rather, by reason of the absence of controls at internal borders, the significant migratory challenges at the external borders, the need to monitor efficiently the crossing of those borders, and the need to contribute to a high level of internal security within the Union, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (121) As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters' association with the implementation, application and development of the Schengen acquis (23), which fall within the area referred to in Article 1, point A of Council Decision 1999/437/EC (24). The Arrangement between the European Community and the Republic of Iceland and the Kingdom of Norway on the modalities of the participation by those States in the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (25) provides for rules on the participation by those countries in the work of the Agency, including provisions on financial contributions and staff. (122) As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (26) which fall within the area referred to in Article 1, point A of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (27). (123) As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (28) which fall within the area referred to in Article 1, point A of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (29). (124) The Arrangement between the European Community, of the one part, and the Swiss Confederation and the Principality of Liechtenstein, of the other part, on the modalities of the participation by those States in the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (30) provides for rules on the participation by those countries in the work of the Agency, including provisions on financial contributions and staff. (125) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it, or subject to its application. Given that this Regulation builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Regulation whether it will implement it in its national law. (126) This Regulation constitutes a development of provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (31); the United Kingdom is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (127) This Regulation constitutes a development of provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (32); Ireland is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (128) The Agency should facilitate the organisation of specific activities in which the Member States may avail themselves of the expertise and facilities which Ireland and the United Kingdom may be willing to offer, on terms to be decided on a case-by-case basis by the management board. To that end, representatives of Ireland may be invited to attend meetings of the management board which allow them to participate fully in the preparation of such specific activities. Representatives of the United Kingdom may be invited to attend the meetings of the management board until the day on which the Treaties cease to apply to the United Kingdom pursuant to Article 50(3) TEU. (129) Although the United Kingdom does not participate in this Regulation, it has been granted the possibility to cooperate with the European Border and Coast Guard in view of its position as a Member State. In view of the submission by the United Kingdom of the notification of its intention to withdraw from the Union pursuant to Article 50 TEU, special arrangements applicable to the operational cooperation with the United Kingdom on the basis of this Regulation should be applicable until the day on which the Treaties cease to apply to the United Kingdom pursuant to Article 50(3) TEU or provided that a withdrawal agreement concluded with the United Kingdom in accordance with Article 50 TEU that regulates such special arrangements has entered into force. (130) A controversy exists between the Kingdom of Spain and the United Kingdom on the demarcation of the borders of Gibraltar. (131) The suspension of the applicability of this Regulation to the borders of Gibraltar does not imply any change in the respective positions of the States concerned. (132) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (33) on 7 November 2018 and delivered an opinion on 30 November 2018. (133) This Regulation aims to amend and expand the provisions of Regulations (EU) 2016/1624 and (EU) No 1052/2013. Since the amendments to be made are substantial in number and nature, those legal acts should, for the sake of clarity, be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I EUROPEAN BORDER AND COAST GUARD Article 1 Subject matter This Regulation establishes a European Border and Coast Guard to ensure European integrated border management at the external borders with a view to managing those borders efficiently in full compliance with fundamental rights and to increasing the efficiency of the Union return policy. This Regulation addresses migratory challenges and potential future challenges and threats at the external borders. It ensures a high level of internal security within the Union in full respect of fundamental rights, while safeguarding the free movement of persons within the Union. It contributes to the detection, prevention and combating of cross-border crime at the external borders. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘external borders’ means external borders as defined in point 2 of Article 2 of Regulation (EU) 2016/399; (2) ‘border crossing point’ means border crossing point as defined in point 8 of Article 2 of Regulation (EU) 2016/399; (3) ‘border control’ means border control as defined in point 10 of Article 2 of Regulation (EU) 2016/399; (4) ‘border checks’ means border checks as defined in point 11 of Article 2 of Regulation (EU) 2016/399; (5) ‘border surveillance’ means border surveillance as defined in point 12 of Article 2 of Regulation (EU) 2016/399; (6) ‘air border surveillance’ means the surveillance of any flight of a manned or unmanned aircraft and its passengers or cargo to or from the territory of the Member States which is not an internal flight as defined in point 3 of Article 2 of Regulation (EU) 2016/399; (7) ‘situational awareness’ means the ability to monitor, detect, identify, track and understand illegal cross-border activities in order to find reasoned grounds for reaction measures on the basis of combining new information with existing knowledge, and to be better able to reduce the loss of lives of migrants at, along or in the proximity of the external borders; (8) ‘reaction capability’ means the ability to perform actions aimed at countering illegal cross-border activities at, along or in the proximity of the external borders, including the means and timelines to react adequately; (9) ‘EUROSUR’ means the framework for information exchange and cooperation between the Member States and the European Border and Coast Guard Agency; (10) ‘situational picture’ means an aggregation of geo-referenced near-real-time data and information received from different authorities, sensors, platforms and other sources which is transmitted across secured communication and information channels and can be processed and selectively displayed and shared with other relevant authorities in order to achieve situational awareness and support the reaction capability at, along or in the proximity of the external borders and the pre-frontier area; (11) ‘external border section’ means the whole or a part of the external border of a Member State, as defined by national law or as determined by the national coordination centre or any other responsible national authority; (12) ‘cross-border crime’ means any serious crime with a cross-border dimension that is committed or attempted at, along or in the proximity of the external borders; (13) ‘pre-frontier area’ means the geographical area beyond the external borders which is relevant for managing the external borders through risk analysis and situational awareness; (14) ‘incident’ means a situation relating to illegal immigration, cross-border crime, or a risk to the lives of migrants at, along or in the proximity of, the external borders; (15) ‘statutory staff’ means staff employed by the European Border and Coast Guard Agency in accordance with the Staff Regulations of Officials of the European Union (the ‘Staff Regulations’) and the Conditions of Employment of Other Servants of the Union (the ‘Conditions of Employment’) laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (34); (16) ‘operational staff’ means border guards, return escorts, return specialists and other relevant staff constituting the European Border and Coast Guard standing corps in accordance with the four categories set out in Article 54(1), acting as members of the teams having executive powers, where applicable, and the statutory staff responsible for the functioning of the European Travel Information and Authorisation System (ETIAS) Central Unit that are not deployable as members of the teams; (17) ‘member of the teams’ means a member of the European Border and Coast Guard standing corps deployed through border management teams, migration management support teams and return teams; (18) ‘border management teams’ means teams formed from the European Border and Coast Guard standing corps to be deployed during joint operations at the external borders and rapid border interventions in Member States and third countries; (19) ‘migration management support teams’ means teams of experts which provide technical and operational reinforcement to Member States, including at hotspot areas, composed of operational staff, experts from the European Asylum Support Office (EASO) and Europol and, where relevant, experts from the European Union Agency for Fundamental Rights (FRA), other Union bodies, offices and agencies and Member States; (20) ‘host Member State’ means a Member State in which a joint operation or a rapid border intervention, a return operation or a return intervention takes place, or from which it is launched, or in which a migration management support team is deployed; (21) ‘home Member State’ means the Member State from which a staff member is deployed or seconded to the European Border and Coast Guard standing corps; (22) ‘participating Member State’ means a Member State which participates in a joint operation, rapid border intervention, return operation, return intervention or in a deployment of a migration management support team, by providing technical equipment or staff of the European Border and Coast Guard standing corps, as well as a Member State which participates in return operations or return interventions by providing technical equipment or staff, but which is not a host Member State; (23) ‘hotspot area’ means an area created at the request of the host Member State in which the host Member State, the Commission, relevant Union agencies and participating Member States cooperate, with the aim of managing an existing or potential disproportionate migratory challenge characterised by a significant increase in the number of migrants arriving at the external borders; (24) ‘return’ means return as defined in point 3 of Article 3 of Directive 2008/115/EC; (25) ‘return decision’ means an administrative or judicial decision or act stating or declaring the stay of a third-country national to be illegal and imposing or stating an obligation to return that respects Directive 2008/115/EC; (26) ‘returnee’ means an illegally staying third-country national who is the subject of an enforceable return decision; (27) ‘return operation’ means an operation that is organised or coordinated by the European Border and Coast Guard Agency and involves technical and operational reinforcement provided to one or more Member States under which returnees from one or more Member States are returned, either on a forced or voluntary basis, irrespective of the means of transport; (28) ‘return intervention’ means an activity of the European Border and Coast Guard Agency providing Member States with enhanced technical and operational assistance consisting of the deployment of return teams and the organisation of return operations; (29) ‘return teams’ means teams formed from the European Border and Coast Guard standing corps to be deployed during return operations, return interventions in Member States or other operational activities linked to the implementation of return-related tasks; (30) ‘immigration liaison officer’ means immigration liaison officer as defined in point 1 of Article 2 of Regulation (EU) 2019/1240 of the European Parliament and of the Council (35). Article 3 European integrated border management 1. European integrated border management shall consist of the following components: (a) border control, including measures to facilitate legitimate border crossings and, where appropriate: measures related to the prevention and detection of cross-border crime at the external borders, in particular migrant smuggling, trafficking in human beings, and terrorism; and mechanisms and procedures for the identification of vulnerable persons and unaccompanied minors, and for the identification of persons who are in need of international protection or wish to apply for such protection, the provision of information to such persons, and the referral of such persons; (b) search and rescue operations for persons in distress at sea launched and carried out in accordance with Regulation (EU) No 656/2014 and with international law, taking place in situations which may arise during border surveillance operations at sea; (c) analysis of the risks for internal security and analysis of the threats that may affect the functioning or security of the external borders; (d) information exchange and cooperation between Member States in the areas covered by this Regulation, as well as information exchange and cooperation between Member States and the European Border and Coast Guard Agency, including the support coordinated by the European Border and Coast Guard Agency; (e) inter-agency cooperation among the national authorities in each Member State which are responsible for border control or for other tasks carried out at the border, as well as between authorities responsible for return in each Member State, including the regular exchange of information through existing information exchange tools, including, where appropriate, cooperation with national bodies in charge of protecting fundamental rights; (f) cooperation among the relevant Union institutions, bodies, offices and agencies in the areas covered by this Regulation, including through regular exchange of information; (g) cooperation with third countries in the areas covered by this Regulation, focusing in particular on neighbouring third countries and on those third countries which have been identified through risk analysis as being countries of origin or transit for illegal immigration; (h) technical and operational measures within the Schengen area which are related to border control and designed to address illegal immigration and to counter cross-border crime better; (i) the return of third-country nationals who are the subject of return decisions issued by a Member State; (j) the use of state-of-the-art technology including large-scale information systems; (k) a quality control mechanism, in particular the Schengen evaluation mechanism, the vulnerability assessment and possible national mechanisms, to ensure the implementation of Union law in the area of border management; (l) solidarity mechanisms, in particular Union funding instruments. 2. Fundamental rights, education and training, as well as research and innovation shall be overarching components in the implementation of European integrated border management. Article 4 European Border and Coast Guard The national authorities of Member States responsible for border management, including coast guards to the extent that they carry out border control tasks, the national authorities responsible for return and the European Border and Coast Guard Agency (‘the Agency’) shall constitute the European Border and Coast Guard. Article 5 European Border and Coast Guard Agency 1. The Agency shall be governed by this Regulation. 2. The Agency shall include the European Border and Coast Guard standing corps (‘the standing corps’) referred to in Article 54 with a capacity of up to 10 000 operational staff in accordance with Annex I. 3. To ensure coherent European integrated border management, the Agency shall facilitate and render more effective the application of Union measures relating to the management of the external borders, in particular Regulation (EU) 2016/399, and of Union measures relating to return. 4. The Agency shall contribute to the continuous and uniform application of Union law, including the Union acquis on fundamental rights, in particular the Charter of Fundamental Rights of the European Union (‘the Charter’), at external borders. Its contribution shall include the exchange of good practices. Article 6 Accountability The Agency shall be accountable to the European Parliament and to the Council in accordance with this Regulation. Article 7 Shared responsibility 1. The European Border and Coast Guard shall implement European integrated border management as a shared responsibility of the Agency and of the national authorities responsible for border management, including coast guards to the extent that they carry out maritime border surveillance operations and any other border control tasks. Member States shall retain primary responsibility for the management of their sections of the external borders. 2. The Agency shall provide technical and operational assistance in the implementation of measures relating to return as referred to in Article 48 of this Regulation, upon request of the Member State concerned or on its own initiative and with the agreement of the Member State concerned. Member States shall retain sole responsibility for issuing return decisions and for adopting the measures pertaining to the detention of returnees in accordance with Directive 2008/115/EC. 3. Member States shall ensure the management of their external borders and the enforcement of return decisions, in close cooperation with the Agency, in their own interests and in the common interest of all Member States in full compliance with Union law, including respect for fundamental rights, and in accordance with the multiannual strategic policy cycle for European integrated border management referred to in Article 8. 4. The Agency shall support the application of Union measures relating to the management of the external borders and the enforcement of return decisions by reinforcing, assessing and coordinating the actions of Member States and by providing technical and operational assistance in the implementation of those measures and in return matters. The Agency shall not support any measures or be involved in any activities related to controls at internal borders. The Agency shall be fully responsible and accountable for any decision it takes and for any activity for which it is solely responsible under this Regulation. 5. Member States may cooperate at an operational level with other Member States or third countries, where such cooperation is compatible with the tasks of the Agency. Member States shall refrain from any activity which could jeopardise the functioning of the Agency or the attainment of its objectives. Member States shall report to the Agency on that operational cooperation with other Member States or third countries at the external borders and in the field of return. The executive director shall inform the management board of such matters on a regular basis and at least once a year. Article 8 Multiannual strategic policy cycle for European integrated border management 1. The Commission and the European Border and Coast Guard shall ensure the effectiveness of European integrated border management by means of a multiannual strategic policy cycle that is adopted in accordance with the procedure laid down in paragraph 4. 2. The multiannual strategic policy for the European integrated border management shall set out how the challenges in the area of border management and return are to be addressed in a coherent, integrated and systematic manner. It shall set out the policy priorities and provide strategic guidelines for a period of five years in relation to the components set out in Article 3. 3. The multiannual strategic policy cycle for European integrated border management shall consist of four stages as set out in paragraphs 4 to 7. 4. On the basis of the strategic risk analysis for European integrated border management referred to in Article 29(2), the Commission shall prepare a policy document developing a multiannual strategic policy for European integrated border management. The Commission shall submit that policy document to the European Parliament and to the Council for discussion. Following that discussion, the Commission shall adopt a communication establishing the multiannual strategic policy for European integrated border management. 5. In order to implement the multiannual strategic policy for European integrated border management, the Agency shall, by a decision of the management board, on the basis of a proposal from the executive director that is prepared in close cooperation with the Member States and the Commission, establish a technical and operational strategy for European integrated border management. Where justified, the Agency shall take into account the specific situations of the Member States, in particular their geographical locations. The technical and operational strategy shall be in line with Article 3 and the multiannual strategic policy for European integrated border management. It shall promote and support the implementation of European integrated border management in all Member States. 6. In order to implement the multiannual strategic policy for European integrated border management, the Member States shall establish national strategies for European integrated border management through close cooperation between all national authorities responsible for the management of external borders and return. Those national strategies shall be in line with Article 3, the multiannual strategic policy for European integrated border management and the technical and operational strategy. 7. Four years after the adoption of the multiannual strategic policy for European integrated border management, the Commission shall carry out a thorough evaluation of its implementation. The results of that evaluation shall be taken into account in the preparation of the following multiannual strategic policy cycle. Member States and the Agency shall provide the Commission with the necessary information in a timely manner for the carrying out of that evaluation. The Commission shall communicate the results of that evaluation to the European Parliament and to the Council. 8. Where the situation at the external borders or in the area of return requires a change of the policy priorities, the Commission shall amend the multiannual strategic policy for European integrated border management or relevant parts thereof in accordance with the procedure set out in paragraph 4. Where the Commission amends the multiannual strategic policy as provided for in the first subparagraph, the technical and operational strategy and the national strategies shall, where necessary, be adapted. Article 9 Integrated planning 1. On the basis of the multiannual strategic policy cycle for European integrated border management, the European Border and Coast Guard shall establish an integrated planning process for border management and return, including operational planning, contingency planning and capability development planning processes. That integrated planning process shall be established in accordance with paragraphs 2, 3 and 4 of this Article. 2. Member States and the Agency shall adopt operational plans for border management and return. The operational plans of Member States related to border sections with high and critical impact levels shall be coordinated with neighbouring Member States and with the Agency with a view to implementing the necessary cross-border measures and providing for support by the Agency. For the activities of the Agency, operational planning processes for the following year shall be set out in an annex to the single programming document referred to in Article 102. For each specific operational activity, operational planning processes shall result in the operational plans referred to in Article 38 and Article 74(3). The operational plans or parts thereof may be classified where appropriate, in accordance with Article 92. 3. Member States shall each adopt a contingency plan for the management of their borders and return. In line with national integrated border management strategies, the contingency plans shall describe all the necessary measures and resources for the possible reinforcement of capabilities, including logistics and support both at national level and from the Agency. The part of the contingency plans that requires additional support from the European Border and Coast Guard shall be jointly prepared by the Member State concerned and the Agency, in close coordination with neighbouring Member States. 4. Member States shall adopt national capability development plans for border management and return in line with their national integrated border management strategies. Those national capability development plans shall describe the medium- to long-term evolution of the national capabilities for border management and return. The national capability development plans shall address the development of each component of European integrated border management, in particular the recruitment and training policy of border guards and return specialists, the acquisition and maintenance of equipment, necessary research and development activities, and the corresponding funding requirements and sources. 5. The contingency plans and national capability development plans referred to in paragraphs 3 and 4 shall be based on scenarios that are derived from risk analysis. Those scenarios shall reflect the possible evolution of the situation at the external borders and in the area of illegal immigration and the challenges identified in the multiannual strategic policy cycle for European integrated border management. Those scenarios shall be set out in the contingency plans and national capability development plans to which they relate. 6. The methodology and the procedure for establishing the plans referred to in paragraphs 3 and 4 shall be adopted by the management board, after consultation with the Member States, on the basis of a proposal of the executive director. 7. The Agency shall prepare an overview of the national capability development plans and a multiannual strategy for the acquisition of the Agency's equipment referred to in Article 63 and the multiannual planning for profiles of staff for the standing corps. The Agency shall share that overview with the Member States and with the Commission with a view to identifying possible synergies and opportunities for cooperation in the various areas covered by the national capability development plans, including joint procurement. On the basis of the identified synergies, the Agency may invite the Member States to participate in follow-up actions for cooperation. 8. The management board shall meet at least once a year to discuss and approve the capability roadmap of the European Border and Coast Guard. The capability roadmap shall be proposed by the executive director on the basis of the overview of the national capability development plans, taking into account, inter alia, the results of the risk analysis and vulnerability assessments carried out in accordance with Articles 29 and 32 and the Agency's own multiannual plans. Once the capability roadmap is approved by the management board, it shall be annexed to the technical and operational strategy referred to in Article 8(5). CHAPTER II FUNCTIONING OF THE EUROPEAN BORDER AND COAST GUARD SECTION 1 Tasks of the European Border and Coast Guard Agency Article 10 Tasks of the European Border and Coast Guard Agency 1. The Agency shall perform the following tasks: (a) monitor migratory flows and carry out risk analysis as regards all aspects of integrated border management; (b) monitor the operational needs of Member States related to the implementation of returns, including by collecting operational data; (c) carry out vulnerability assessments, including assessments of the capacity and readiness of Member States to face threats and challenges at the external borders; (d) monitor the management of the external borders through liaison officers of the Agency in Member States; (e) monitor compliance with fundamental rights in all of its activities at the external borders and in return operations; (f) support the development and operation of EUROSUR; (g) assist Member States in circumstances requiring increased technical and operational assistance at the external borders by coordinating and organising joint operations, taking into account that some situations may involve humanitarian emergencies and rescue at sea in accordance with Union and international law; (h) assist Member States in circumstances requiring increased technical and operational assistance at the external borders by launching rapid border interventions at the external borders of those Member States facing specific and disproportionate challenges, taking into account that some situations may involve humanitarian emergencies and rescue at sea in accordance with Union and international law; (i) provide technical and operational assistance to Member States and third countries in accordance with Regulation (EU) No 656/2014 and international law, in support of search and rescue operations for persons in distress at sea which may arise during border surveillance operations at sea; (j) deploy the standing corps in the framework of border management teams, migration management support teams and return teams (collectively referred to as ‘teams’) during joint operations, as well as in rapid border interventions, return operations and return interventions; (k) set up a technical equipment pool, including a rapid reaction equipment pool, to be deployed in joint operations, in rapid border interventions and in the framework of migration management support teams, as well as in return operations and return interventions; (l) develop and manage, with the support of an internal quality control mechanism, its own human and technical capabilities to contribute to the standing corps, including to the recruitment and training of the members of its staff acting as members of the teams, and the technical equipment pool; (m) within the framework of the migration management support teams at hotspot areas: (i) deploy operational staff and technical equipment to provide assistance in screening, debriefing, identification and fingerprinting; (ii) establish a procedure for referring and providing initial information to persons who are in need of international protection or wish to apply for such protection, including a procedure for the identification of vulnerable groups, in cooperation with EASO and competent national authorities; (n) provide assistance at all stages of the return process without entering into the merits of return decisions, which remain the sole responsibility of the Member States, assist with the coordination and organisation of return operations and provide technical and operational support to implement the obligation to return returnees and technical and operational support to return operations and interventions, including in circumstances requiring increased assistance; (o) set up a pool of forced-return monitors; (p) deploy return teams during return interventions; (q) within the respective mandates of the agencies concerned, cooperate with Europol and Eurojust and provide support to Member States in circumstances requiring increased technical and operational assistance at the external borders in the fight against cross-border crime and terrorism; (r) cooperate with EASO within their respective mandates, in particular to facilitate measures in cases where third-country nationals whose applications for international protection have been rejected by means of a final decision are subject to return; (s) cooperate with the FRA, within their respective mandates, in order to ensure the continuous and uniform application of the Union acquis on fundamental rights; (t) cooperate with the European Fisheries Control Agency (EFCA) and the European Maritime Safety Agency (EMSA), within their respective mandates, in order to support national authorities carrying out coast guard functions, as set out in Article 69, including the saving of lives at sea, by providing services, information, equipment and training, as well as by coordinating multipurpose operations; (u) cooperate with third countries in relation to the areas covered by this Regulation, including through the possible operational deployment of border management teams in third countries; (v) assist Member States and third countries in the context of technical and operational cooperation between them in the matters covered by this Regulation; (w) assist Member States and third countries in the training of national border guards, other relevant staff and experts on return, including through the establishment of common training standards and programmes, including on fundamental rights; (x) participate in the development and management of research and innovation activities relevant for the control of the external borders, including the use of advanced surveillance technology, and develop its own pilot projects, where necessary, for the carrying out of activities as provided for in this Regulation; (y) develop technical standards for information exchange; (z) support the development of technical standards for equipment in the area of border control and return, including for the interconnection of systems and networks, and support, as appropriate, the development of common minimum standards for external border surveillance, in line with the respective competences of the Member States and of the Commission; (aa) establish and maintain the communication network referred to in Article 14; (ab) develop and operate, in accordance with Regulation (EU) 2018/1725, information systems that enable swift and reliable exchanges of information regarding emerging risks in the management of the external borders, illegal immigration and return, in close cooperation with the Commission, Union bodies, offices and agencies as well as the European Migration Network established by Council Decision 2008/381/EC (36); (ac) provide the necessary assistance for the development of a common information-sharing environment, including interoperability of systems, as appropriate; (ad) follow high standards for border management allowing for transparency and public scrutiny in full respect of the applicable law and ensuring respect for, and protection and promotion of, fundamental rights; (ae) manage and operate the False and Authentic Documents Online system referred to in Article 79 and support the Member States by facilitating the detection of document fraud; (af) fulfil the tasks and obligations entrusted to the Agency under Regulation (EU) 2018/1240 of the European Parliament and of the Council (37) and ensure the setting up and operation of the ETIAS Central Unit in accordance with Article 7 of that Regulation; (ag) assist Member States in facilitating persons to cross the external borders. 2. The Agency shall communicate on matters falling within its mandate. It shall provide the public with accurate, detailed, timely and comprehensive information about its activities. Such communication shall not be detrimental to the tasks referred to in paragraph 1 of this Article, and in particular shall not reveal operational information which, if made public, would jeopardise attainment of the objective of operations. The Agency shall communicate without prejudice to Article 92 and in accordance with relevant communication and dissemination plans adopted by the management board and in close cooperation, where appropriate, with other bodies, offices and agencies. SECTION 2 Information exchange and cooperation Article 11 Duty to cooperate in good faith The Agency, the national authorities responsible for border management, including coast guards to the extent that they carry out border control tasks, and the national authorities responsible for return shall be subject to a duty to cooperate in good faith and an obligation to exchange information. Article 12 Obligation to exchange information 1. In order to perform the tasks conferred on them by this Regulation, the Agency, the national authorities responsible for border management, including coast guards to the extent that they carry out border control tasks, and the national authorities responsible for return shall, in accordance with this Regulation and other relevant Union and national law regarding the exchange of information, share in a timely and accurate manner all necessary information. 2. The Agency shall take appropriate measures to facilitate the exchange of information relevant to its tasks with the Commission and the Member States. Where information is relevant to the performance of its tasks, the Agency shall exchange that information with other relevant Union bodies, offices and agencies for the purpose of risk analysis, collecting statistical data, assessing the situation in third countries, training and the support to Member States in connection with contingency planning. For that purpose, the necessary tools and structures shall be developed between the Union bodies, offices and agencies. 3. The Agency shall take all necessary measures to facilitate the exchange of information relevant for its tasks with Ireland and the United Kingdom where that information relates to the activities in which they participate in accordance with Article 70 and Article 100(5). Article 13 National contact points 1. Each Member State shall appoint a national contact point for communication with the Agency on all matters pertaining to the activities of the Agency, without prejudice to the role of the national coordination centres. The national contact points shall be reachable at all times and shall ensure the timely dissemination of all information from the Agency to all the relevant authorities within the Member State concerned, in particular the members of the management board and the national coordination centre. 2. Member States may designate up to two staff members representing their national contact point to be assigned to the Agency as liaison officers. The liaison officers shall facilitate communication between the national contact point and the Agency and may, where necessary, attend relevant meetings. 3. The Agency shall provide liaison officers with the necessary premises within its headquarters and with adequate support for the performance of their duties. All other costs that arise in connection with the deployment of liaison officers shall be covered by the Member State. The management board shall specify the rules and conditions of the deployment, as well as the rules concerning adequate support to be provided. Article 14 Communication network 1. The Agency shall establish and maintain a communication network in order to provide communication and analytical tools and allow for the exchange of sensitive non-classified and classified information in a secure manner and in near real time with, and among, the national coordination centres. Any system or application using the communication network shall comply with Union law on data protection throughout its life cycle. The communication network shall be operational twenty-four hours a day and seven days a week and shall allow for: (a) bilateral and multilateral information exchange in near real time; (b) audio and video conferencing; (c) secure handling, storing, transmission and processing of sensitive non-classified information; (d) secure handling, storing, transmission and processing of EU classified information up to the level of CONFIDENTIEL UE/EU CONFIDENTIAL or equivalent national classification levels, ensuring that classified information is handled, stored, transmitted and processed in a separate and duly accredited part of the communication network. 2. The Agency shall provide technical support and ensure that the communication network is permanently available and can support the communication and information system managed by the Agency. Article 15 Information exchange systems and applications managed by the Agency 1. The Agency may take all necessary measures to facilitate the exchange of information relevant to its tasks with the European Parliament, the Council, the Commission, the Member States and, where appropriate, other Union institutions, and the Union bodies, offices and agencies and international organisations listed in Article 68(1) and third countries as referred to in Article 71. 2. The Agency shall develop, deploy and operate an information system capable of exchanging classified and sensitive non-classified information with the actors referred to in paragraph 1 of this Article, and of exchanging personal data referred to in Articles 86 to 91 in accordance with Article 92. 3. The Agency shall deploy the information systems referred to in paragraph 2 of this Article on the communication network referred to in Article 14 as appropriate. Article 16 Technical standards for information exchange The Agency shall develop technical standards in cooperation with the Member States in order to: (a) interconnect the communication network referred to in Article 14 with national networks used for establishing the national situational pictures referred to in Article 25 and other relevant information systems for the purpose of this Regulation; (b) develop, and establish interfaces between, relevant information exchange systems and software applications of the Agency and of the Member States for the purpose of this Regulation; (c) broadcast situational pictures and, as appropriate, specific situational pictures as referred to in Article 27 and ensure communication between relevant units and centres of competent national authorities and with the teams deployed by the Agency by using various means of communication such as satellite communications and radio networks; (d) report the position of own assets, making the best possible use of the technological development of the satellite navigation system established under the Galileo programme in accordance with Regulation (EU) No 1285/2013 of the European Parliament and of the Council (38). Article 17 Information assurance Member States shall ensure via their national coordination centre and under the supervision of the competent national authorities that their national authorities, agencies and other bodies, when using the communication network referred to in Article 14 and the information exchange systems of the Agency: (a) have proper and continuous access to the relevant systems and networks of the Agency or to systems and networks connected to them; (b) comply with the relevant technical standards referred to in Article 16; (c) apply equivalent security rules and standards as those applied by the Agency for the handling of classified information; (d) exchange, process and store sensitive non-classified and classified information in compliance with Article 92. SECTION 3 EUROSUR Article 18 EUROSUR This Regulation establishes EUROSUR as an integrated framework for the exchange of information and for operational cooperation within the European Border and Coast Guard in order to improve situational awareness and to increase reaction capability for the purposes of border management, including the detection, prevention and combating of illegal immigration and cross-border crime and contributing to ensuring the protection and saving the lives of migrants. Article 19 Scope of EUROSUR 1. EUROSUR shall be used for border checks at authorised border crossing points and for external land, sea and air border surveillance, including the monitoring, detection, identification, tracking, prevention and interception of unauthorised border crossings for the purpose of detecting, preventing and combating illegal immigration and cross-border crime and contributing to ensuring the protection and saving the lives of migrants. 2. EUROSUR shall not be used for any legal or administrative measure taken once the competent authorities of a Member State have intercepted cross-border criminal activities or unauthorised crossings by persons of the external borders. Article 20 EUROSUR components 1. Member States and the Agency shall use EUROSUR for the exchange of information and for the cooperation in the field of border control, taking into account existing information exchange and cooperation mechanisms. EUROSUR shall consist of the following components: (a) national coordination centres as referred to in Article 21; (b) national situational pictures as referred to in Article 25; (c) a European situational picture as referred to in Article 26, including information on external border sections with corresponding impact levels; (d) specific situational pictures as referred to in Article 27; (e) EUROSUR fusion services as referred to in Article 28; (f) integrated planning as referred to in Article 9. 2. The national coordination centres shall provide the Agency, via the communication network referred to in Article 14 and relevant systems, with information from their national situational pictures and, as appropriate, from specific situational pictures, which is required for the establishment and maintenance of the European situational picture. 3. The Agency shall give the national coordination centres, via the communication network, unlimited access twenty-four hours a day, seven days a week, to specific situational pictures and to the European situational picture. Article 21 National coordination centres 1. Each Member State shall designate, operate and maintain a national coordination centre which shall coordinate, and exchange information among, all authorities having responsibility for external border control at national level, as well as with the other national coordination centres and the Agency. Each Member State shall notify the establishment of its national coordination centre to the Commission, which shall forthwith inform the other Member States and the Agency thereof. 2. Without prejudice to Article 13 and within the framework of EUROSUR, the national coordination centre shall be the single point of contact for the exchange of information and for the cooperation with other national coordination centres and with the Agency. 3. The national coordination centres shall: (a) ensure the timely exchange of information and timely cooperation between all national authorities having responsibility for external border control at national level, as well as with other national coordination centres and the Agency; (b) ensure the timely exchange of information with search and rescue, law enforcement, asylum and immigration authorities and manage the dissemination of relevant information at national level; (c) contribute to an effective and efficient management of resources and personnel; (d) establish and maintain the national situational pictures in accordance with Article 25; (e) support the coordination, planning and implementation of national border control; (f) coordinate the national border control systems, in accordance with national law; (g) contribute to regularly measuring the effects of national border control for the purposes of this Regulation; (h) coordinate operational measures with other Member States and third countries, without prejudice to the competences of the Agency and of the other Member States; (i) exchange relevant information with the immigration liaison officers of their Member State, where designated, through appropriate structures established at national level, with a view to contributing to the European situational picture and supporting border control operations; (j) under the supervision of the competent national authorities, contribute to the information assurance of national information systems and the Agency's information systems. 4. Member States may charge regional, local, functional or other authorities which are in a position to take operational decisions with ensuring situational awareness and reaction capability in their respective areas of competence, including the tasks and competences listed in points (c), (e) and (f) of paragraph 3. 5. The decision of a Member State to allocate tasks in accordance with paragraph 4 shall not affect the national coordination centre in its ability to cooperate and exchange information with other national coordination centres and the Agency. 6. In pre-defined cases, as determined at national level, a national coordination centre may authorise an authority referred to in paragraph 4 to communicate and exchange information with the regional authorities or the national coordination centre of another Member State or the competent authorities of a third country on condition that such authorised authority regularly informs its own national coordination centre of such communication and exchange of information. 7. The national coordination centre shall operate twenty-four hours a day, seven days a week. Article 22 EUROSUR Handbook 1. The Commission shall, in close cooperation with the Agency and any other relevant Union body, office or agency, adopt and make available a practical handbook for the implementation and management of EUROSUR (the ‘EUROSUR Handbook’). The EUROSUR Handbook shall provide technical and operational guidelines, recommendations and best practices, including in relation to cooperation with third countries. The Commission shall adopt the EUROSUR Handbook in the form of a recommendation. 2. The Commission may decide, after consultation with Member States and the Agency, to classify parts of the EUROSUR Handbook as RESTREINT UE/EU RESTRICTED in compliance with the rules laid down in the Rules of Procedure of the Commission. Article 23 Monitoring of EUROSUR 1. The Agency and the Member States shall ensure that procedures are in place to monitor the technical and operational functioning of EUROSUR against the objectives of achieving an adequate situational awareness and reaction capability at the external borders. 2. The Agency shall continuously monitor the quality of the service offered by the communication network referred to in Article 14 and the quality of the data shared in the European situational picture. 3. The Agency shall transmit information collected as part of the monitoring under paragraph 2 to the national coordination centres and the relevant command and control structures used for the Agency's operations as part of the EUROSUR fusion services. Such information shall be classified RESTREINT UE/EU RESTRICTED. SECTION 4 Situational awareness Article 24 Situational pictures 1. The national situational pictures, the European situational picture and the specific situational pictures shall be produced through the collection, evaluation, collation, analysis, interpretation, generation, visualisation and dissemination of information. The situational pictures referred to in the first subparagraph shall consist of the following information layers: (a) an events layer that includes events and incidents related to unauthorised border crossings and cross-border crime and, where available, information on unauthorised secondary movements, for the purpose of understanding migratory trends, volume and routes; (b) an operational layer that contains information on operations, including the deployment plan, area of operations, and the position, time, status and type of assets participating as provided for in the operational plan; (c) an analysis layer that contains analysed information which is relevant for the purposes of this Regulation and, in particular, is relevant to the attribution of impact levels to the external border sections, such as imagery and geo-data, key developments and indicators, analytical reports, and other relevant supporting information. 2. The situational pictures referred to in paragraph 1 shall allow for the identification and tracing of events, operations and corresponding analysis relating to situations where human lives are at risk. 3. The Commission shall adopt an implementing act laying down the details of the information layers of the situational pictures and the rules for the establishment of specific situational pictures. The implementing act shall specify the type of information to be provided, the entities responsible for collecting, processing, archiving and transmitting specific information, the maximum time limits for reporting, the data security and data protection rules and related quality control mechanisms. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 122(2). Article 25 National situational pictures 1. Each national coordination centre shall establish and maintain a national situational picture in order to provide all authorities having responsibility for external border control at national level with effective, accurate and timely information. 2. The national situational picture shall be composed of information collected from the following sources: (a) the national border surveillance system in accordance with national law; (b) stationary and mobile sensors operated by national authorities having responsibility for external border surveillance; (c) patrols on border surveillance and other monitoring missions; (d) local, regional and other coordination centres; (e) other relevant national authorities and systems, including immigration liaison officers, operational centres and contact points; (f) border checks; (g) the Agency; (h) national coordination centres in other Member States; (i) authorities of third countries, on the basis of bilateral or multilateral agreements and regional networks referred to in Article 72; (j) ship reporting systems in accordance with their respective legal bases; (k) other relevant European and international organisations (l) other sources. 3. Each national coordination centre shall attribute a single indicative impact level, ranging from ‘low’ and ‘medium’ to ‘high’ and ‘very high’, to each incident in the events layer of the national situational picture. All incidents shall be shared with the Agency. 4. Each national coordination centre may decide, at the request of the competent national authorities, to restrict access to information related to national security, including military assets, on a need-to-know basis. 5. The national coordination centres of neighbouring Member States may share with each other, directly and in near real time, the situational picture of neighbouring external border sections, including the positions, status and type of own assets operating in the neighbouring external border sections. Article 26 European situational picture 1. The Agency shall establish and maintain a European situational picture in order to provide the national coordination centres and the Commission with effective, accurate and timely information and analysis, covering the external borders, the pre-frontier area and unauthorised secondary movements. 2. The European situational picture shall be composed of information collected from the following sources: (a) national coordination centres, and national situational pictures and information and reports received from immigration liaison officers to the extent required by this Article; (b) the Agency, including the information and reports provided by its liaison officers in accordance with Articles 31 and 77; (c) Union delegations and Common Security and Defence Policy (CSDP) missions and operations as provided for in point (j) of the second subparagraph of Article 68(1); (d) other relevant Union bodies, offices and agencies and international organisations listed in Article 68(1); (e) authorities of third countries, on the basis of bilateral or multilateral agreements and regional networks as referred to in Article 72, and working arrangements as referred to in Article 73(4); (f) other sources. 3. The events layer of the European situational picture shall include information relating to: (a) incidents and other events contained in the events layer of the national situational pictures; (b) incidents and other events contained in the specific situational pictures as provided for in Article 27; (c) incidents in the operational area of a joint operation or rapid intervention coordinated by the Agency, or in a hotspot. 4. The operational layer of the European situational picture shall contain information on the joint operations and rapid interventions coordinated by the Agency and on hotspots, and shall include the mission statements, locations, status, duration, information on the Member States and other actors involved, daily and weekly situational reports, statistical data and information packages for the media. 5. Information on own assets in the operational layer of the European situational picture may, where appropriate, be classified as RESTREINT UE/EU RESTRICTED. 6. In the European situational picture, the Agency shall take into account the impact levels that were assigned to specific incidents in national situational pictures by the national coordination centres. For any incident in the pre-frontier area, the Agency shall assign a single indicative impact level and shall inform the national coordination centres thereof. Article 27 Specific situational pictures 1. The Agency and the Member States may establish and maintain specific situational pictures in order to support specific operational activities at the external borders or to share information with Union institutions, bodies, offices and agencies and international organisations listed in Article 68(1) or third countries as provided for in Article 75. 2. The specific situational pictures shall be composed of a subset of information of the national and European situational pictures. 3. The detailed rules for establishing and sharing the specific situational pictures shall be set out in an operational plan for the operational activities concerned and in a bilateral or multilateral agreement where a specific situational picture is established in the framework of bilateral or multilateral cooperation with third countries. Any sharing of information under this paragraph shall be carried out in accordance with the principle of originator's consent. Article 28 EUROSUR fusion services 1. The Agency shall coordinate the EUROSUR Fusion Services in order to supply the national coordination centres, the Commission and itself with information on the external borders and on the pre-frontier area on a regular, reliable and cost-efficient basis. 2. The Agency shall provide a national coordination centre, at its request, with information on the external borders of the Member State to which it belongs and on the pre-frontier area which may be derived from: (a) the selective monitoring of designated third-country ports and coasts which have been identified through risk analysis and information as being embarkation or transit points for vessels or other craft used for illegal immigration or cross-border crime; (b) the tracking of vessels or other craft over high seas and the tracking of aircraft, where those vessels, other craft or aircraft are suspected of, or have been identified as, being used for illegal immigration or cross-border crime, including in the case of persons in distress at sea, with a view to transmitting that information to the relevant authorities that are competent for search and rescue operations; (c) monitoring of designated areas in the maritime domain in order to detect, identify and track vessels and other craft being used for, or suspected of being used for, illegal immigration or cross-border crime, including in the case of persons in distress at sea with a view to transmitting that information to the relevant authorities that are competent for search and rescue operations; (d) monitoring of designated areas of air borders in order to detect, identify and track aircraft and other forms of equipment being used for, or suspected of being used for, illegal immigration or cross-border crime; (e) environmental assessment of designated areas in the maritime domain and at the external land and air borders in order to optimise monitoring and patrolling activities; (f) selective monitoring of designated pre-frontier areas at the external borders which have been identified through risk analysis and information as being potential departure or transit areas for illegal immigration or cross-border crime; (g) monitoring migratory flows towards and within the Union in terms of trends, volume and routes; (h) media monitoring, open source intelligence and analysis of internet activities in line with Directive (EU) 2016/680 or Regulation (EU) 2016/679, as applicable, for the purpose of preventing illegal immigration or cross-border crime; (i) analysis of information derived from large-scale information systems for the purpose of detecting changing routes and methods used for illegal immigration and cross-border crime. 3. The Agency may refuse a request from a national coordination centre for technical, financial or operational reasons. The Agency shall notify the national coordination centre in due time of the reasons for such a refusal. 4. The Agency may use, on its own initiative, the surveillance tools referred to in paragraph 2 for collecting information on the pre-frontier area, which is relevant for the European situational picture. SECTION 5 Risk analysis Article 29 Risk analysis 1. The Agency shall monitor migratory flows towards the Union, and within the Union in terms of migratory trends, volume and routes, and other trends or possible challenges at the external borders and with regard to return. For that purpose, the Agency shall, by a decision of the management board based on a proposal from the executive director, establish a common integrated risk analysis model, which shall be applied by the Agency and the Member States. The common integrated risk analysis model shall be established and updated, where needed, on the basis of the outcome of the evaluation of the implementation of the multiannual strategic policy cycle for European integrated border management referred to in Article 8(7). 2. The Agency shall prepare general annual risk analyses, which shall be submitted to the European Parliament, to the Council and to the Commission applying the security rules adopted in accordance with Article 92, and tailored risk analyses for operational activities. Every two years, the Agency, in close consultation with the Member States, shall prepare and submit to the European Parliament, to the Council and to the Commission a strategic risk analysis for European integrated border management. Such strategic risk analyses shall be taken into account for the preparation of the multiannual strategic policy cycle for European integrated border management. The Agency shall prepare such general annual risk analyses and strategic risk analyses on the basis of information received, including from the Member States. Personal data shall be anonymised in the results of such risk analyses. 3. The risk analyses referred to in paragraph 2 shall cover all aspects relevant to European integrated border management with a view to developing a pre-warning mechanism. 4. The Agency shall publish comprehensive information on the common integrated risk analysis model. 5. Member States shall provide the Agency with all necessary information regarding the situation, trends and possible threats at the external borders and in the field of return. Member States shall regularly, or upon the request of the Agency, provide it with all relevant information such as statistical and operational data collected in relation to European integrated border management that is included in the list of mandatory information and data to be exchanged with the Agency as referred to in point (e) of Article 100(2), as well as information from the analysis layers of the national situational pictures as provided for in Article 25. 6. The results of the risk analysis shall be submitted to the management board and shared with the competent authorities of the Member States in a timely and accurate manner. 7. Member States shall take results of the risk analysis into account when planning their operations and activities at the external borders and their activities with regard to return. 8. The Agency shall incorporate the results of a common integrated risk analysis model in its development of common core curricula for training as referred to in Article 62. SECTION 6 Prevention and responsiveness Article 30 Determination of external border sections For the purposes of this Regulation, each Member State shall divide its external borders into external border sections. Those sections shall consist of land, sea and, where a Member State so decides, air border sections. Each Member State shall notify such external border sections to the Agency. Member States shall notify any change of external border sections to the Agency in a timely manner to ensure the continuity of risk analysis by the Agency. Article 31 Agency liaison officers in Member States 1. The Agency shall ensure the regular monitoring of all Member States' management of the external borders and return through liaison officers of the Agency. The Agency may decide that a liaison officer covers up to four Member States which are geographically close to each other. 2. The executive director shall appoint experts from the statutory staff to be deployed as liaison officers. The executive director shall, on the basis of risk analysis and in consultation with the Member States concerned, make a proposal on the nature and terms of the deployment, the Member State or region to which a liaison officer may be deployed and possible tasks not covered by paragraph 3. The proposal from the executive director shall be subject to approval by the management board. The executive director shall notify the Member State concerned of the appointment and shall determine, together with that Member State, the location of deployment. 3. The liaison officers shall act on behalf of the Agency, and their role shall be to foster cooperation and dialogue between the Agency and the national authorities responsible for border management, including coast guards to the extent that they carry out border control tasks, as well as the national authorities responsible for return. The liaison officers shall, in particular: (a) act as an interface between the Agency and the national authorities responsible for border management, including coast guards to the extent that they carry out border control tasks, as well as the national authorities responsible for return; (b) support the collection of information required by the Agency for the monitoring of illegal immigration and risk analyses referred to in Article 29; (c) support the collection of information referred to in Article 32 and required by the Agency to carry out vulnerability assessments and prepare a report for that purpose; (d) monitor the measures taken by the Member State at external border sections to which a high or critical impact level has been attributed in accordance with Article 34; (e) contribute to promoting the application of the Union acquis relating to the management of the external borders and return, including with regard to respect for fundamental rights; (f) cooperate with the fundamental rights officer, where necessary, with a view to promoting respect for fundamental rights in the work of the Agency in line with point (e); (g) where possible, assist the Member States in preparing their contingency plans concerning border management; (h) facilitate the communication between the Member State concerned and the Agency, share relevant information from the Agency with the Member State concerned, including information about ongoing operations; (i) report regularly and directly to the executive director on the situation at the external borders and the capacity of the Member State concerned to deal effectively with the situation at the external borders; report also on the execution of return operations towards relevant third countries; (j) monitor the measures taken by the Member State with regard to a situation requiring urgent action at the external borders as referred to in Article 42; (k) monitor the measures taken by the Member State with regard to return and support the collection of information required by the Agency to carry out the activities referred to in Article 48. 4. If the reporting by the liaison officer referred to in point (i) of paragraph 3 raises concerns about one or more aspects relevant for the Member State concerned, the executive director shall inform that Member State without delay. 5. For the purposes of paragraph 3, the liaison officer shall, in compliance with the national and Union security and data protection rules: (a) receive information from the national coordination centre concerned and the relevant national situational picture established in accordance with Article 25; (b) keep regular contacts with national authorities which are responsible for border management, including coast guards to the extent that they carry out border control tasks, as well as the national authorities responsible for return, whilst informing the national contact point concerned. 6. The report of the liaison officer referred to in point (c) of paragraph 3 of this Article shall form part of the vulnerability assessment referred to in Article 32. The report shall be transmitted to the Member State concerned. 7. In carrying out their duties, the liaison officers shall take instructions only from the Agency. Article 32 Vulnerability assessment 1. The Agency shall establish a common vulnerability assessment methodology by decision of the management board, on the basis of a proposal from the executive director prepared in close cooperation with the Member States and the Commission. That methodology shall include objective criteria against which the Agency shall carry out the vulnerability assessment, the frequency of such assessments, how consecutive vulnerability assessments are to be carried out, and arrangements for an effective system for monitoring the implementation of recommendations of the executive director as referred to in paragraph 7. 2. The Agency shall monitor and assess the availability of the technical equipment, systems, capabilities, resources, infrastructure and adequately skilled and trained staff of Member States necessary for border control as referred to in point (a) of Article 3(1). In that context, the Agency shall assess the national capability development plans referred to in Article 9(4) as regards the capacity to perform border control taking into account the fact that some national capabilities may be partially used for purposes other than border control. For future planning, the Agency shall carry out such monitoring and assessment as a preventive measure on the basis of the risk analyses prepared in accordance with Article 29(2). The Agency shall carry out such monitoring and assessment at least once a year, unless the executive director, on the basis of risk analysis or a previous vulnerability assessment, decides otherwise. In any event, each Member State shall be subject to monitoring and assessment at least once every three years. 3. Without prejudice to Article 9, Member States shall, at the request of the Agency, provide information as regards technical equipment, staff and, to the extent possible, the financial resources available at national level to carry out border control. Member States shall also provide information on their contingency plans on border management at the Agency's request. 4. The aim of the vulnerability assessment is for the Agency: to assess the capacity and readiness of Member States to face present and upcoming challenges at the external borders; to identify, especially for those Member States facing specific and disproportionate challenges, possible immediate consequences at the external borders and subsequent consequences on the functioning of the Schengen area; to assess their capacity to contribute to the standing corps and to the technical equipment pool, including the rapid reaction equipment pool; and to assess the hosting capacity of Member States with regard to support from the European Border and Coast Guard in line with Article 9(3). That assessment shall be without prejudice to the Schengen evaluation mechanism. 5. In the vulnerability assessment, the Agency shall assess, in qualitative and quantitative terms, the Member States' capacity to carry out all border management tasks, including their capacity to deal with the potential arrival of large numbers of persons on their territory. 6. The preliminary results of the vulnerability assessment shall be submitted to the Member States concerned. The Member States concerned may comment on that assessment. 7. Where necessary, the executive director, in consultation with the Member State concerned, shall make a recommendation setting out the necessary measures to be taken by the Member State concerned and the time limit within which such measures are to be implemented. The executive director shall invite the Member States concerned to take the necessary measures on the basis of an action plan developed by the Member State in consultation with the executive director. 8. The executive director shall base the measures to be recommended to the Member States concerned on the results of the vulnerability assessment, taking into account the Agency's risk analysis, the comments of the Member State concerned and the results of the Schengen evaluation mechanism. The recommended measures shall be aimed at eliminating the vulnerabilities identified in the assessment in order for Member States to increase their readiness to face present and upcoming challenges at the external borders by enhancing or improving their capabilities, technical equipment, systems, resources and contingency plans. The executive director may offer the technical expertise of the Agency to the Member States to support the implementation of the recommended measures. 9. The executive director shall monitor the implementation of the recommended measures by means of regular reports to be submitted by the Member States on the basis of the action plans referred to in paragraph 7. Where there is a risk that a Member State will not implement a recommended measure within the time limit set in accordance with paragraph 7, the executive director shall immediately inform the member of the management board from the Member State concerned and the Commission. In consultation with the member of the management board from the Member State concerned, the executive director shall enquire of the relevant authorities of that Member State about the reasons for the delay and offer support by the Agency to facilitate the implementation of the measure recommended. 10. Where a Member State does not implement the necessary measures of the recommendation within the time limit set in accordance with paragraph 7 of this Article, the executive director shall refer the matter to the management board and notify the Commission. The management board shall adopt a decision on the basis of a proposal from the executive director, setting out the necessary measures to be taken by the Member State concerned and the time limit within which such measures are to be implemented. The decision of the management board shall be binding on the Member State. If the Member State does not implement the measures within the time limit provided for in that decision, the management board shall notify the Council and the Commission and further action may be taken in accordance with Article 42. 11. The vulnerability assessment, including a detailed description of the outcome of the vulnerability assessment, the measures taken by the Member States in response to the vulnerability assessment and the status of the implementation of any measures previously recommended, shall be transmitted, in accordance with Article 92, on a regular basis and at least once a year to the European Parliament, to the Council and to the Commission. Article 33 Synergies between the vulnerability assessment and the Schengen evaluation mechanism 1. The synergies between the vulnerability assessment and the Schengen evaluation mechanism shall be maximised in order to establish an improved situational picture on the functioning of the Schengen area, avoiding, to the extent possible, the duplication of efforts on the Member States' side, and ensuring a better coordinated use of the relevant Union financial instruments supporting the management of the external borders. 2. For the purpose referred to in paragraph 1, the Commission and the Agency shall establish the necessary arrangements to share with each other in a regular, secured and timely manner all information related to the results of vulnerability assessments and the results of the evaluations carried out within the framework of the Schengen evaluation mechanism in the area of border management. Those information-sharing arrangements shall cover the reports of vulnerability assessments and reports of Schengen evaluation visits, subsequent recommendations, action plans and any updates on the implementation of the action plans provided by the Member States. 3. For the purposes of the Schengen evaluation mechanism as it relates to external border management, the Commission shall share the results of the vulnerability assessments with all the members of the Schengen evaluation teams involved in the evaluation of the Member State concerned. Such information shall be considered sensitive within the meaning of Regulation (EU) No 1053/2013 and shall be treated accordingly. 4. The arrangements referred to in paragraph 2 shall cover results of the evaluations carried out within the framework of the Schengen evaluation mechanism in the area of return to ensure the full awareness of the Agency of the identified deficiencies in view of enabling it to propose appropriate measures to support Member States concerned in that regard. Article 34 Attribution of impact levels to external border sections 1. On the basis of the Agency's risk analysis and vulnerability assessment and in agreement with the Member State concerned, the Agency shall attribute the following impact levels to each external border section or change such levels: (a) low impact level where the incidents related to illegal immigration or cross-border crime occurring at the relevant border section have an insignificant impact on border security; (b) medium impact level where the incidents related to illegal immigration or cross-border crime occurring at the relevant border section have a moderate impact on border security; (c) high impact level where the incidents related to illegal immigration or cross-border crime occurring at the relevant border section have a significant impact on border security. 2. In order to swiftly address a crisis situation at a particular external border section, where the Agency's risk analysis shows that incidents related to illegal immigration or cross-border crime occurring at the relevant external border section have a decisive impact on border security to such an extent that they risk jeopardising the functioning of the Schengen area, the Agency shall, in agreement with the Member State concerned, temporarily attribute a ‘critical’ impact level to that external border section. 3. Where there is no agreement between the Member State concerned and the Agency on the attribution of an impact level to an external border section, the impact level that was previously attributed to that border section shall remain unchanged. 4. The national coordination centre shall constantly assess in close cooperation with other competent national authorities whether there is a need to change the impact level of any of the external border sections by taking into account the information contained in the national situational picture and inform the Agency accordingly. 5. The Agency shall indicate the impact levels attributed to the external border sections in the European situational picture. Article 35 Reaction corresponding to impact levels 1. The Member States shall ensure that border control at the external border sections corresponds to the attributed impact levels in the following manner: (a) where a low impact level is attributed to an external border section, the national authorities responsible for external border control shall organise regular border control on the basis of risk analysis and ensure that sufficient personnel and resources are being kept available for that border section; (b) where a medium impact level is attributed to an external border section, the national authorities responsible for external border control shall, in addition to the measures taken under point (a) of this paragraph, ensure that appropriate border control measures are being taken at that border section; where such border control measures are taken, the national coordination centre shall be notified accordingly; the national coordination centre shall coordinate any support given in accordance with Article 21(3); (c) where a high impact level is attributed to an external border section, the Member State concerned, in addition to the measures taken under point (b) of this paragraph, shall ensure, through the national coordination centre, that the national authorities operating at that border section are given the necessary support and that reinforced border control measures are taken; that Member State may request support from the Agency subject to the conditions for initiating joint operations or rapid border interventions as laid down in Article 36; (d) where a critical impact level is attributed to an external border section, the Agency shall notify the Commission thereof; the executive director, in addition to the measures taken under point (c) of this paragraph, shall issue a recommendation in accordance with Article 41(1), taking into account the ongoing support by the Agency; the Member State concerned shall respond to the recommendation in accordance with Article 41(2). 2. The national coordination centres shall regularly inform the Agency of the measures taken at national level pursuant to points (c) and (d) of paragraph 1. 3. Where a medium, high or critical impact level is attributed to an external border section which is adjacent to the border section of another Member State or of a third country with which agreements, arrangements or regional networks, as referred to in Articles 72 and 73, are in place, the national coordination centre shall contact the national coordination centre of the neighbouring Member State or the competent authority of the neighbouring third country and shall endeavour to coordinate together with the Agency the necessary cross-border measures. 4. The Agency shall, together with the Member State concerned, evaluate the attribution of impact levels and the corresponding measures taken at national and Union level. That evaluation shall contribute to the vulnerability assessment to be carried out by the Agency in accordance with Article 32. SECTION 7 Action by the Agency at the external borders Article 36 Actions by the Agency at the external borders 1. A Member State may request the Agency's assistance in implementing its obligations with regard to external border control. The Agency shall also carry out measures in accordance with Articles 41 and 42. 2. The Agency shall organise the appropriate technical and operational assistance for the host Member State and it may, acting in accordance with the relevant Union and international law, including the principle of non-refoulement, take one or more of the following measures: (a) coordinate joint operations for one or more Member States and deploy the standing corps and technical equipment; (b) organise rapid border interventions and deploy the standing corps and technical equipment; (c) coordinate activities for one or more Member States and third countries at the external borders, including joint operations with third countries; (d) deploy the standing corps in the framework of the migration management support teams to, inter alia, hotspot areas in order to provide technical and operational assistance, including, where necessary, in return activities; (e) within the framework of operations referred to in points (a), (b) and (c) of this paragraph and in accordance with Regulation (EU) No 656/2014 and international law, provide technical and operational assistance to Member States and third countries in support of search and rescue operations for persons in distress at sea which may arise during border surveillance operations at sea; (f) give priority treatment to the EUROSUR fusion services. 3. The Agency shall finance or co-finance the activities referred to in paragraph 2 from its budget in accordance with the financial rules applicable to the Agency. 4. If the Agency has substantial additional financial needs due to a situation at the external borders, it shall inform the European Parliament, the Council and the Commission thereof without delay. Article 37 Initiating joint operations and rapid border interventions at the external borders 1. A Member State may request that the Agency launch joint operations to face upcoming challenges, including illegal immigration, present or future threats at its external borders or cross-border crime, or provide increased technical and operational assistance when implementing its obligations with regard to external border control. As part of such a request, a Member State may also indicate the profiles of operational staff needed for the joint operation in question, including those staff having executive powers, as applicable. 2. At the request of a Member State faced with a situation of specific and disproportionate challenges, especially the arrival at points of the external borders of large numbers of third-country nationals trying to enter the territory of that Member State without authorisation, the Agency may deploy a rapid border intervention for a limited period of time on the territory of that host Member State. 3. The executive director shall evaluate, approve and coordinate proposals made by Member States for joint operations or rapid border interventions. Joint operations and rapid border interventions shall be preceded by a thorough reliable and up-to-date risk analysis, thereby enabling the Agency to set an order of priority for the proposed joint operations and rapid border interventions, taking into account the impact levels attributed to external border sections in accordance with Article 34 and the availability of resources. 4. The objectives of a joint operation or rapid border intervention may be achieved as part of a multipurpose operation. Such operations may involve coast guard functions and the prevention of cross-border crime, focusing on the fight against migrant smuggling or trafficking in human beings, and migration management, focusing on identification, registration, debriefing and return. Article 38 Operational plans for joint operations 1. In preparation of a joint operation the executive director, in cooperation with the host Member State, shall draw up a list of technical equipment, staff and profiles of staff needed, including those staff having executive powers, as applicable, to be authorised in accordance with Article 82(2). That list shall be drawn up taking into account the host Member State's available resources and the host Member State's request under Article 37. On the basis of those elements, the Agency shall define a package of technical and operational reinforcement as well as capacity-building activities to be included in the operational plan. 2. The executive director shall draw up an operational plan for joint operations at the external borders. The executive director and the host Member State, in close and timely consultation with the participating Member States, shall agree on the operational plan detailing the organisational and procedural aspects of the joint operation. 3. The operational plan shall be binding on the Agency, the host Member State and the participating Member States. It shall cover all aspects considered necessary for carrying out the joint operation, including the following: (a) description of the situation, with modus operandi and objectives of the deployment, including the operational aim; (b) the estimated time that the joint operation is expected to last in order to achieve its objectives; (c) the geographical area where the joint operation will take place; (d) a description of the tasks, including those requiring executive powers, responsibilities, including with regard to the respect for fundamental rights and data protection requirements, and special instructions for the teams, including on permissible consultation of databases and permissible service weapons, ammunition and equipment in the host Member State; (e) the composition of the teams as well as the deployment of other relevant staff; (f) command and control provisions, including the names and ranks of the border guards of the host Member State responsible for cooperating with the members of the teams and the Agency, in particular the names and ranks of those border guards who are in command during the period of deployment, and the place of the members of the teams in the chain of command; (g) the technical equipment to be deployed during the joint operation, including specific requirements such as conditions for use, requested crew, transport and other logistics, and financial provisions; (h) detailed provisions on immediate incident reporting by the Agency to the management board and to relevant national authorities; (i) a reporting and evaluation scheme containing benchmarks for the evaluation report, including with regard to the protection of fundamental rights, and final date of submission of the final evaluation report; (j) regarding sea operations, specific information on the application of the relevant jurisdiction and applicable law in the geographical area where the joint operation takes place, including references to national, international and Union law regarding interception, rescue at sea and disembarkation; in that regard the operational plan shall be established in accordance with Regulation (EU) No 656/2014; (k) the terms of cooperation with third countries, other Union bodies, offices and agencies or international organisations; (l) general instructions on how to ensure the safeguarding of fundamental rights during the operational activity of the Agency; (m) procedures whereby persons in need of international protection, victims of trafficking in human beings, unaccompanied minors and persons in a vulnerable situation are directed to the competent national authorities for appropriate assistance; (n) procedures setting out a mechanism to receive and transmit to the Agency complaints against any person participating in an operational activity of the Agency, including border guards or other relevant staff of the host Member State and members of the teams, alleging breaches of fundamental rights in the context of their participation in an operational activity of the Agency; (o) logistical arrangements, including information on working conditions and the environment of the areas in which the joint operation is to take place. 4. Any amendments to or adaptations of the operational plan shall require the agreement of the executive director and the host Member State, after consultation of the participating Member States. A copy of the amended or adapted operational plan shall immediately be sent by the Agency to the participating Member States. 5. This Article shall apply mutatis mutandis to all operations of the Agency. Article 39 Procedure for launching a rapid border intervention 1. A request by a Member State to launch a rapid border intervention shall include a description of the situation, possible aims and envisaged needs, and the profiles of staff needed, including those staff having executive powers, as applicable. If required, the executive director may immediately send experts from the Agency to assess the situation at the external borders of the Member State concerned. 2. The executive director shall immediately inform the management board of a Member State's request to launch a rapid border intervention. 3. When deciding on the request of a Member State, the executive director shall take into account the findings of the Agency's risk analyses and the analysis layer of the European situational picture as well as the outcome of the vulnerability assessment referred to in Article 32 and any other relevant information provided by the Member State concerned or another Member State. 4. The executive director shall immediately assess the possibilities for redeployment of available members of the teams within the standing corps, in particular statutory staff and staff seconded to the Agency by the Member States, present in other operational areas. The executive director shall also assess the additional need to deploy operational staff in accordance with Article 57 and, once staff within the required profiles have been exhausted, to activate the reserve for rapid reaction in accordance with Article 58. 5. The executive director shall take a decision on the request to launch a rapid border intervention within two working days from the date of receipt of the request. The executive director shall simultaneously notify the Member State concerned and the management board in writing of the decision. The decision shall state the main reasons on which it is based. 6. When taking the decision referred to in paragraph 5 of this Article, the executive director shall inform the Member States about the possibility of requesting additional operational staff in accordance with Article 57 and, where applicable, Article 58 by indicating possible numbers and profiles of staff to be provided by each Member State. 7. If the executive director decides to launch a rapid border intervention, he or she shall deploy available border management teams from the standing corps and equipment from the technical equipment pool in accordance with Article 64, and where necessary, he or she shall decide on the immediate reinforcement by one or more border management teams, in accordance with Article 57. 8. The executive director together with the host Member State shall draw up and agree upon an operational plan as referred to in Article 38(2) immediately and, in any event, no later than three working days from the date of the decision. 9. As soon as the operational plan has been agreed upon and provided to the Member States, the executive director shall immediately deploy the operational staff available through redeployments from other operational areas or other duties. 10. In parallel to the deployment referred to in paragraph 9, and where necessary to secure the immediate reinforcement of the border management teams redeployed from other areas or duties, the executive director shall request from each Member State the number and profiles of additional staff to be additionally deployed from their national lists for short-term deployments as referred to in Article 57. 11. If a situation arises where the border management teams referred to in paragraph 7 and the staff referred to in paragraph 10 of this Article are insufficient, the executive director may activate the reserve for rapid reaction by requesting from each Member State the number and profiles of additional staff to be deployed as provided for in Article 58. 12. The information referred to paragraphs 10 and 11 shall be provided in writing to the national contact points and shall indicate the date on which the deployments of staff from each category are to take place. A copy of the operational plan shall also be provided to the national contact points. 13. Member States shall ensure that the number and profiles of staff are immediately made available to the Agency to guarantee a complete deployment in accordance with Article 57 and, if applicable, Article 58. 14. The deployment of the first border management teams redeployed from other areas and other duties shall take place no later than five working days after the date on which the operational plan is agreed between the executive director and the host Member State. Additional deployment of border management teams shall take place, where necessary, no later than 12 working days after the date on which the operational plan is agreed. 15. Where the rapid border intervention is to take place, the executive director shall, in consultation with the management board, immediately consider the priorities with regard to the Agency's ongoing and planned joint operations at other external borders in order to provide for possible reallocation of resources to the areas of the external borders where a strengthened deployment is most needed. Article 40 Migration management support teams 1. Where a Member State faces disproportionate migratory challenges at particular hotspot areas of its external borders characterised by large inward mixed migratory flows, that Member State may request technical and operational reinforcement by migration management support teams composed of experts from relevant Union bodies, offices and agencies that shall operate in accordance with their mandates. That Member State shall submit a request for reinforcement and an assessment of its needs to the Commission. On the basis of that assessment of needs, the Commission shall transmit the request, as appropriate, to the Agency, to EASO, to Europol and to other relevant Union bodies, offices and agencies. 2. The relevant Union bodies, offices and agencies shall examine, in accordance with their respective mandates, the Member State's request for reinforcement and the assessment of its needs for the purpose of defining a comprehensive reinforcement package consisting of various activities coordinated by the relevant Union bodies, offices and agencies, to be agreed upon by the Member State concerned. The Commission shall coordinate that process. 3. The Commission, in cooperation with the host Member State and the relevant Union bodies, offices and agencies in accordance with their respective mandates, shall establish the terms of cooperation at the hotspot area and shall be responsible for the coordination of the activities of the migration management support teams. 4. The technical and operational reinforcement provided, with full respect for fundamental rights, by the standing corps in the framework of migration management support teams may include the provision of: (a) assistance, with full respect for fundamental rights, in the screening of third-country nationals arriving at the external borders, including the identification, registration, and debriefing of those third-country nationals and, where requested by the Member State, the fingerprinting of third-country nationals and providing information regarding the purpose of these procedures; (b) initial information to persons who wish to apply for international protection and the referral of those persons to the competent national authorities of the Member State concerned or to the experts deployed by EASO; (c) technical and operational assistance in the field of return in accordance with Article 48, including the preparation and organisation of return operations; (d) necessary technical equipment. 5. Migration management support teams shall include, where necessary, staff with expertise in child protection, trafficking in human beings, protection against gender-based persecution or fundamental rights. Article 41 Proposed actions at the external borders 1. On the basis of the results of the vulnerability assessment or where a critical impact level is attributed to one or more external border sections and taking into account the relevant elements in the Member State's contingency plans, the Agency's risk analysis and the analysis layer of the European situational picture, the executive director shall recommend to the Member State concerned to request that the Agency initiate, carry out or adjust joint operations, rapid border interventions or any other relevant actions by the Agency as set out in Article 36. 2. The Member State concerned shall respond to the recommendation of the executive director referred to in paragraph 1 within six working days. In the event of a negative response to the recommendation, the Member State shall also provide the justifications underlying that response. The executive director shall notify the management board and the Commission without delay about the recommended actions and the justifications for the negative response, with a view to assessing whether urgent action may be required in accordance with Article 42. Article 42 Situation at the external borders requiring urgent action 1. Where external border control is rendered ineffective to such an extent that it risks jeopardising the functioning of the Schengen area because: (a) a Member State does not implement the necessary measures in accordance with a decision of the management board referred to in Article 32(10); or (b) a Member State facing specific and disproportionate challenges at the external borders has either not requested sufficient support from the Agency under Article 37, 39 or 40 or is not taking the necessary steps to implement actions under those Articles or under Article 41; the Council, on the basis of a proposal from the Commission, may adopt without delay a decision by means of an implementing act to identify measures to mitigate those risks to be implemented by the Agency and requiring the Member State concerned to cooperate with the Agency in the implementation of those measures. The Commission shall consult the Agency before making its proposal. 2. Where a situation requiring urgent action arises, the European Parliament shall be informed of that situation without delay as well as of any subsequent measures and decisions taken in response. 3. To mitigate the risk of putting the Schengen area in jeopardy, the Council decision referred to in paragraph 1 shall provide for one or more of the following measures to be taken by the Agency: (a) organise and coordinate rapid border interventions and deploy the standing corps, including teams from the reserve for rapid reaction; (b) deploy the standing corps in the framework of the migration management support teams, in particular at hotspot areas; (c) coordinate activities for one or more Member States and third countries at the external borders, including joint operations with third countries; (d) deploy technical equipment; (e) organise return interventions. 4. The executive director shall, within two working days from the date of adoption of the Council decision referred to in paragraph 1: (a) determine the actions to be taken for the practical execution of the measures identified in that decision, including the technical equipment and the number and profiles of the operational staff needed to meet the objectives of that decision; (b) draw up a draft operational plan and submit it to the Member States concerned. 5. The executive director and the Member State concerned shall agree on the operational plan referred to in point (b) of paragraph 4 within three working days from the date of its submission. 6. The Agency shall, without delay, and in any case within five working days from the establishment of the operational plan, deploy the necessary operational staff from the standing corps for the practical execution of the measures identified in the Council decision referred to in paragraph 1. Additional teams shall be deployed as necessary at a second stage, and in any case within 12 working days from the establishment of the operational plan. 7. The Agency and the Member States shall, without delay, and in any case within 10 working days from the establishment of the operational plan, send the necessary technical equipment and competent staff to the destination of deployment for the practical execution of the measures identified in the Council decision referred to in paragraph 1. Additional technical equipment shall be deployed as necessary at a second stage in accordance with Article 64. 8. The Member State concerned shall comply with the Council decision referred to in paragraph 1. For that purpose, it shall immediately cooperate with the Agency and take the necessary action to facilitate the implementation of that decision and the practical execution of the measures set out in that decision and in the operational plan agreed upon with the executive director, in particular by implementing the obligations provided for in Articles 43, 82 and 83. 9. In accordance with Article 57 and, where relevant, Article 39, the Member States shall make available the operational staff determined by the executive director in accordance with paragraph 4 of this Article. 10. The Commission shall monitor the implementation of the measures identified in the Council decision referred to in paragraph 1 and the actions that the Agency takes for that purpose. If the Member State concerned does not comply with the Council decision referred to in paragraph 1 of this Article within 30 days and does not cooperate with the Agency in accordance with to paragraph 8 of this Article, the Commission may trigger the procedure provided for in Article 29 of Regulation (EU) 2016/399. Article 43 Instructions to the teams 1. During the deployment of border management teams, return teams and migration management support teams, the host Member State or, in the case of cooperation with a third country in accordance with a status agreement, the third country concerned, shall issue instructions to the teams in accordance with the operational plan. 2. The Agency, through its coordinating officer, may communicate its views to the host Member State on the instructions given to the teams. In that case, the host Member State shall take those views into consideration and follow them to the extent possible. 3. In cases where the instructions issued to the teams are not in compliance with the operational plan, the coordinating officer shall immediately report to the executive director, who may, if appropriate, take action in accordance with Article 46(3). 4. Members of the teams shall, in the performance of their tasks and in the exercise of their powers, fully respect fundamental rights, including access to asylum procedures and human dignity, and shall pay particular attention to vulnerable persons. Any measures taken in the performance of their tasks and in the exercise of their powers shall be proportionate to the objectives pursued by such measures. While performing their tasks and exercising their powers, they shall not discriminate against persons on the basis of any grounds such as sex, race, colour, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation in line with Article 21 of the Charter. 5. Members of the teams who are not statutory staff shall remain subject to the disciplinary measures of their home Member State. The home Member State shall provide for appropriate disciplinary or other measures in accordance with its national law regarding violations of fundamental rights or international protection obligations in the course of any operational activity by the Agency. 6. Statutory staff deployed as members of the teams shall be subject to disciplinary measures as provided for in the Staff Regulations and the Conditions of Employment and measures of a disciplinary nature provided for in the supervisory mechanism referred to in point (a) of Article 55(5). Article 44 Coordinating officer 1. The Agency shall ensure the operational implementation of all the organisational aspects of joint operations, pilot projects or rapid border interventions, including the presence of statutory staff. 2. Without prejudice to Article 60, the executive director shall appoint one or more experts from the statutory staff to be deployed as a coordinating officer for each joint operation or rapid border intervention. The executive director shall notify the host Member State of the appointment. 3. The coordinating officer shall act on behalf of the Agency in all aspects of the deployment of the teams. The role of the coordinating officer shall be to foster cooperation and coordination among host and participating Member States. At least one fundamental rights monitor shall assist and advise the coordinating officer. In particular, the coordinating officer shall: (a) act as an interface between the Agency, the host Member State and the members of the teams, providing assistance, on behalf of the Agency, on all issues relating to the conditions of the deployment to the teams; (b) monitor the correct implementation of the operational plan, including, in cooperation with the fundamental rights monitors, as regards the protection of fundamental rights and report to the executive director on this; (c) act on behalf of the Agency in all aspects of the deployment of the teams and report to the Agency on all those aspects; (d) report to the executive director where the instructions issued to the teams by the host Member States are not in compliance with the operational plan, in particular as regards fundamental rights and, where appropriate, suggest that the executive director consider taking a decision in accordance with Article 46. 4. In the context of joint operations or rapid border interventions, the executive director may authorise the coordinating officer to assist in resolving any disagreement on the execution of the operational plan and deployment of the teams. Article 45 Costs 1. The Agency shall fully cover the following costs incurred by Member States in making available their staff for the purposes of deploying them from the standing corps as members of the teams to the Member States and to third countries for a short term in accordance with Article 57 or to the Member States through the reserve for rapid reaction in accordance with Article 58: (a) travel costs from the home Member State to the host Member State, from the host Member State to the home Member State, within the host Member State for the purposes of deployment or redeployment within that host Member State or to another host Member State, and for the purposes of deployments to, and redeployments within or to, another third country; (b) costs related to vaccinations; (c) costs related to special insurance needs; (d) costs related to health care, including psychological assistance; (e) daily subsistence allowances, including accommodation costs. 2. On the basis of a proposal of the executive director, the management board shall adopt detailed rules as regards the reimbursement of the costs incurred by staff deployed for a short term in accordance with Articles 57 and 58, and shall update them as necessary. To ensure compliance with the applicable legal framework, the executive director shall make such proposal after receiving the positive opinion of the Commission. The detailed rules shall be based to the extent possible on simplified cost options in accordance with points (c), (d) and (e) of Article 125(1) of Regulation (EU, Euratom) 2018/1046. Where relevant, the management board shall ensure consistency with the rules applicable to mission expenses of statutory staff. Article 46 Decisions to suspend, terminate or not launch activities 1. The executive director shall terminate any activity of the Agency if the conditions to conduct those activities are no longer fulfilled. The executive director shall inform the Member State concerned prior to such termination. 2. The Member States participating in an operational activity by the Agency may request that the executive director terminate that operational activity. The executive director shall inform the management board of such request. 3. The executive director may, after informing the Member State concerned, withdraw the financing of an activity or suspend or terminate it if the operational plan is not respected by the host Member State. 4. The executive director shall, after consulting the fundamental rights officer and informing the Member State concerned, withdraw the financing for any activity by the Agency, or suspend or terminate any activity by the Agency, in whole or in part, if he or she considers that there are violations of fundamental rights or international protection obligations related to the activity concerned that are of a serious nature or are likely to persist. 5. The executive director shall, after consulting the fundamental rights officer, decide not to launch any activity by the Agency where he or she considers that there would already be serious reasons at the beginning of the activity to suspend or terminate it because it could lead to violations of fundamental rights or international protection obligations of a serious nature. The executive director shall inform the Member State concerned of that decision. 6. The decisions referred to in paragraphs 4 and 5 shall be based on duly justified grounds. When taking such decisions, the executive director shall take into account relevant information such as the number and substance of registered complaints that have not been resolved by a national competent authority, reports of serious incidents, reports from coordinating officers, relevant international organisations and Union institutions, bodies, offices and agencies in the areas covered by this Regulation. The executive director shall inform the management board of such decisions and provide it with justifications therefor. 7. If the executive director decides to suspend or terminate deployment by the Agency of a migration management support team, he or she shall inform the other relevant bodies, offices and agencies active in the hotspot area of that decision. Article 47 Evaluation of activities The executive director shall evaluate the results of all the Agency's operational activities. He or she shall transmit detailed evaluation reports to the management board within 60 days following the end of those activities, together with the observations of the fundamental rights officer. The executive director shall make a comprehensive analysis of those results with a view to enhancing the quality, coherence and effectiveness of future activities, and shall include that analysis in the Agency's annual activity report. The executive director shall ensure that the Agency takes the analysis of those results into account in future operational activities. SECTION 8 Action by the Agency in the area of return Article 48 Return 1. Without entering into the merits of return decisions, which remain the sole responsibility of the Member States, and in accordance with the respect for fundamental rights, general principles of Union law and international law, including international protection, the respect for the principle of non-refoulement and children's rights, with regard to return, the Agency shall: (a) provide technical and operational assistance to Member States in the area of return, including in: (i) the collection of information necessary for issuing return decisions, the identification of third-country nationals subject to return procedures and other pre-return, return-related and post-arrival and post-return activities of the Member States, to achieve an integrated system of return management among competent authorities of the Member States, with the participation of relevant authorities of third countries and other relevant stakeholders; (ii) the acquisition of travel documents, including by means of consular cooperation, without disclosing information relating to the fact that an application for international protection has been made or any other information that is not necessary for the purpose of the return; (iii) the organisation and coordination of return operations and provide assistance in relation to voluntary returns in cooperation with the Member States; (iv) assisted voluntary returns from the Member States, providing assistance to returnees during the pre-return, return-related and post-arrival and post-return phases, taking into account the needs of vulnerable persons; (b) provide technical and operational assistance to Member States experiencing challenges with regard to their return systems; (c) develop, in consultation with the fundamental rights officer, a non-binding reference model for national IT systems for return case management which describes the structure of such systems, as well as provide technical and operational assistance to Member States in developing such systems compatible with the model; (d) operate and further develop an integrated return management platform and a communication infrastructure that enables the linking of the return management systems of the Member States with the platform for the purpose of exchanging data and information, including the automated transmission of statistical data, and provide technical and operational assistance to Member States in connecting to the communication infrastructure; (e) organise, promote and coordinate activities enabling the exchange of information and the identification and pooling of best practices in return matters between the Member States; (f) finance or co-finance from its budget, in accordance with the financial rules applicable to the Agency, the operations, interventions and activities referred to in this Chapter, including reimbursing the costs incurred for the necessary adaptation of the national IT systems for return case management for the purpose of ensuring secure communication to the integrated return management platform. 2. The technical and operational assistance referred to in point (b) of paragraph 1 shall include activities to help Member States carry out return procedures by the competent national authorities by providing, in particular: (a) interpreting services; (b) practical information, including the analysis of such information, and recommendations by the Agency on third countries of return relevant for the implementation of this Regulation, in cooperation, where appropriate, with other Union bodies, offices and agencies, in particular EASO; (c) advice on the implementation and management of return procedures in compliance with Directive 2008/115/EC; (d) advice on and assistance in the implementation of measures taken by Member States in compliance with Directive 2008/115/EC and international law that are necessary to ensure the availability of returnees for return purposes and to prevent returnees from absconding and advice on and assistance in relation to alternatives to detention; (e) equipment, resources and expertise for the implementation of return decisions and for the identification of third-country nationals. 3. The Agency shall aim at building synergies and connecting Union-funded networks and programmes in the field of return in close cooperation with the Commission and with the support of relevant stakeholders, including the European Migration Network. Article 49 Information exchange systems and management of return 1. The Agency shall operate and further develop, in accordance with point (d) of Article 48(1), an integrated return management platform for processing information, including personal data transmitted by the Member States' return management systems, that is necessary for the Agency to provide technical and operational assistance. Personal data shall only include biographic data or passenger lists. Personal data shall be transmitted only where they are necessary for the Agency to assist in the coordination or organisation of return operations to third countries, irrespective of the means of transport. Such personal data shall be transmitted to the platform only once a decision to launch a return operation has been taken, and shall be erased as soon as the operation is terminated. Biographic data shall only be transmitted to the platform where they cannot be accessed by members of teams in accordance with Article 17(3) of Regulation (EU) 2018/1860 of the European Parliament and of the Council (39). The Agency may also use the platform for the purpose of securely transmitting biographic or biometric data, including all types of documents which can be considered as proof or prima facie evidence of the nationality of third-country nationals subject to return decisions, where the transmission of such personal data is necessary for the Agency to provide assistance, at the request of a Member State, in confirming the identity and nationality of third-country nationals in individual cases. Such data shall not be stored on the platform and shall be erased immediately following a confirmation of receipt. 2. The Agency shall develop, deploy and operate information systems and software applications allowing for the exchange of information for the purpose of return within the European Border and Coast Guard and for the purpose of exchanging personal data. 3. Personal data shall be processed in accordance with Articles 86, 87, 88 and 91, as applicable. Article 50 Return operations 1. Without entering into the merits of return decisions, which remain the sole responsibility of the Member States, the Agency shall provide Member States with technical and operational assistance and shall ensure the coordination or the organisation of return operations, including through the chartering of aircraft for the purpose of such operations and organising returns on scheduled flights or by other means of transport. The Agency may, on its own initiative and with the agreement of the Member State concerned, coordinate or organise return operations. 2. Member States shall provide operational data on returns necessary for the assessment of return needs by the Agency through the platform referred to in Article 49(1) and shall inform the Agency of their indicative planning as regards the number of returnees and the third countries of return, both with respect to relevant national return operations, and of their needs for assistance or coordination by the Agency. The Agency shall draw up and maintain a rolling operational plan to provide the requesting Member States with the necessary operational assistance and reinforcements, including through technical equipment. The Agency may, either on its own initiative and with the agreement of the Member State concerned or at the request of a Member State, include in the rolling operational plan the dates and destinations of return operations it considers necessary, based on a needs assessment. The management board shall decide, on the basis of a proposal from the executive director, on the modus operandi of the rolling operational plan. The Member State concerned shall confirm to the Agency that all returnees covered by a return operation organised or coordinated by the Agency are the subject of an enforceable return decision. Where members of the teams are deployed, they shall consult the Schengen Information System prior to the return of any returnee in order to check whether the return decision issued in relation to that returnee has been suspended or whether its enforcement has been postponed. The rolling operational plan shall contain the elements necessary for carrying out a return operation, including those concerning the respect for fundamental rights, and shall refer to, inter alia, relevant codes of conduct and procedures for monitoring, reporting and the complaints mechanism. 3. The Agency may provide technical and operational assistance to the Member States and may also, either on its own initiative and with the agreement of the Member State concerned or at the request of the participating Member States, ensure the coordination or the organisation of return operations for which the means of transport and return escorts are provided by a third country of return (‘collecting return operations’). The participating Member States and the Agency shall ensure that the respect for fundamental rights, the principle of non-refoulement, the proportionate use of means of constraints and the dignity of the returnee are guaranteed during the entire return operation. At least one Member State representative, and one forced-return monitor from the pool established under Article 51 or from the monitoring system of the participating Member State, shall be present throughout the entire return operation until arrival at the third country of return. 4. The executive director shall draw up a return plan for collecting return operations without delay. The executive director and any participating Member State shall agree on the plan detailing the organisational and procedural aspects of the collecting return operation, taking account of the implications for the fundamental rights and risks of such operations. Any amendment to or adaptation of that plan shall require the agreement of the parties referred to in paragraph 3 and in this paragraph. The return plan for collecting return operations shall be binding on the Agency and any participating Member State. It shall cover all the necessary steps for carrying out collecting return operations. 5. Every return operation organised or coordinated by the Agency shall be monitored in accordance with Article 8(6) of Directive 2008/115/EC. The monitoring of forced-return operations shall be carried out by the forced-return monitor on the basis of objective and transparent criteria and shall cover the whole return operation from the pre-departure phase until the handover of the returnees in the third country of return. The forced-return monitor shall submit a report on each forced-return operation to the executive director, the fundamental rights officer and to the competent national authorities of all the Member States involved in the given operation. If necessary, appropriate follow-up shall be ensured by the executive director and competent national authorities respectively. 6. If the Agency has concerns regarding the respect of fundamental rights at any stage of a return operation, it shall communicate them to the participating Member States and to the Commission. 7. The executive director shall evaluate the results of the return operations and shall transmit every six months a detailed evaluation report to the European Parliament, to the Council, to the Commission and to the management board covering all return operations conducted in the previous semester, together with the observations of the fundamental rights officer. The executive director shall make a comprehensive comparative analysis of those results with a view to enhancing the quality, coherence and effectiveness of future return operations. The executive director shall include that analysis in the Agency's annual activity report. 8. The Agency shall finance or co-finance return operations from its budget, in accordance with the financial rules applicable to the Agency, giving priority to those conducted by more than one Member State, or from hotspot areas. Article 51 Pool of forced-return monitors 1. The Agency shall, after taking due account of the opinion of the fundamental rights officer, constitute a pool of forced-return monitors from competent bodies of the Member States who carry out forced-return monitoring activities in accordance with Article 8(6) of Directive 2008/115/EC and who have been trained in accordance with Article 62 of this Regulation. 2. The management board shall, on the basis of a proposal from the executive director, determine the profile and the number of forced-return monitors to be made available to that pool. The same procedure shall apply with regard to any subsequent changes in the profile and overall numbers. Member States shall be responsible for contributing to the pool by nominating forced-return monitors corresponding to the defined profile, without prejudice to the independence of those monitors under national law, where national law so provides. The Agency shall also contribute fundamental rights monitors as referred to in Article 110 to the pool. Forced-return monitors with specific expertise in child protection shall be included in the pool. 3. Member States' contribution of forced-return monitors to return operations and interventions for the following year shall be planned on the basis of annual bilateral negotiations and agreements between the Agency and Member States. In accordance with those agreements, Member States shall make the forced-return monitors available for deployment at the request of the Agency, unless they are faced with an exceptional situation substantially affecting the discharge of national tasks. Such a request shall be made at least 21 working days before the intended deployment, or five working days in the case of a rapid return intervention. 4. The Agency shall make the forced-return monitors available upon request to participating Member States to monitor, on their behalf, the correct implementation of the return operations and return interventions throughout their duration. It shall make available forced-return monitors with specific expertise in child protection for any return operation involving children. 5. Forced-return monitors shall remain subject to the disciplinary measures of their home Member State in the course of a return operation or return intervention. Statutory staff deployed as forced-return monitors shall be subject to the disciplinary measures provided for in the Staff Regulations and the Conditions of Employment. Article 52 Return teams 1. The Agency may deploy return teams either on its own initiative and with the agreement of the Member State concerned or at the request of that Member State. The Agency may deploy such return teams during return interventions, in the framework of migration management support teams or as necessary to provide additional technical and operational assistance in the area of return. Where necessary, return teams shall contain officers with specific expertise in child protection. 2. Article 40(2) to (5) and Articles 43, 44 and 45 shall apply mutatis mutandis to the return teams. Article 53 Return interventions 1. Where a Member State is facing a burden when implementing the obligation to return returnees, the Agency shall provide the appropriate technical and operational assistance in the form of a return intervention, either on its own initiative and with the agreement of the Member State concerned or at the request of that Member State. Such intervention may consist in the deployment of return teams to the host Member State providing assistance in the implementation of return procedures and the organisation of return operations from the host Member State. Article 50 shall apply also to return operations organised or coordinated by the Agency in the framework of return interventions. 2. Where a Member State is facing specific and disproportionate challenges when implementing its obligation to return returnees, the Agency shall provide the appropriate technical and operational assistance in the form of a rapid return intervention, either on its own initiative and with the agreement of the Member State concerned or at the request of that Member State. A rapid return intervention may consist in the rapid deployment of return teams to the host Member State providing assistance in the implementation of return procedures and the organisation of return operations from the host Member State. 3. In the context of a return intervention, the executive director shall draw up an operational plan without delay, in agreement with the host Member State and the participating Member States. The provisions of Article 38 shall apply mutatis mutandis. 4. The executive director shall take a decision on the operational plan as soon as possible and, in the case referred to in paragraph 2, within five working days. The decision shall be immediately notified, in writing, to the Member States concerned and to the management board. 5. The Agency shall finance or co-finance return interventions from its budget in accordance with the financial rules applicable to the Agency. SECTION 9 Capabilities Article 54 European Border and Coast Guard standing corps 1. A European Border and Coast Guard standing corps with the capacity set out in Annex I shall be part of the Agency. The standing corps shall be composed of the following four categories of operational staff in accordance with the annual availability scheme set out in Annex I: (a) category 1: statutory staff deployed as members of the teams in operational areas in accordance with Article 55, as well as staff responsible for the functioning of the ETIAS Central Unit; (b) category 2: staff seconded from Member States to the Agency for a long term as part of the standing corps in accordance with Article 56; (c) category 3: staff from Member States who are ready to be provided to the Agency for a short-term deployment as part of the standing corps in accordance with Article 57; and (d) category 4: the reserve for rapid reaction consisting of staff from the Member States who are ready to be deployed in accordance with Article 58 for the purposes of rapid border interventions in accordance with Article 39. 2. The Agency shall deploy members of the standing corps as members of the border management teams, migration management support teams and return teams in joint operations, rapid border interventions, return interventions or any other relevant operational activities in the Member States or in third countries. Such activities shall only be carried out with the authorisation of the Member State or the third country concerned. The actual number of staff deployed from the standing corps shall depend on the operational needs. Deployment of the standing corps shall be complementary to the efforts undertaken by the Member States. 3. When providing support to the Member States, the members of the standing corps deployed as members of the teams shall have the ability to carry out border control or return tasks, including tasks requiring executive powers provided for in the relevant national law or, in the case of statutory staff, the tasks requiring executive powers set out in Article 55(7). The members of the standing corps shall meet the requirements for specialised training and professionalism as provided for in the third subparagraph of Article 16(1) of Regulation (EU) 2016/399 or other relevant instruments. 4. On the basis of a proposal from the executive director taking into account the Agency's risk analysis, the results of the vulnerability assessment and the multiannual strategic policy cycle for European integrated border management, and building on the numbers and profiles of staff available to the Agency through its statutory staff and ongoing secondments, by 31 March of each year the management board shall adopt a decision: (a) defining the profiles of, and setting out the requirements for, operational staff; (b) on the number of staff per specific profile of categories 1, 2 and 3 staff to form teams in the following year, based on the expected operational needs for the following year; (c) specifying further the contributions set out in Annexes II and III by setting the specific numbers and profiles of staff per Member State to be seconded to the Agency in accordance with Article 56 and to be nominated in accordance with Article 57 in the following year; (d) specifying further the contributions set out in Annex IV by setting the specific numbers and profiles of staff per Member State under the reserve for rapid reaction to be provided in the following year in the event of rapid border interventions in accordance with Articles 39 and 58; and (e) setting out an indicative multiannual planning of profiles for the subsequent years to facilitate the long-term planning for the Member States' contributions and the recruitment of statutory staff. 5. The crew for technical equipment provided in accordance with Article 64 shall be taken into account as part of the contributions for short-term deployments provided by the Member States pursuant to Article 57 for the following year. With a view to preparing the relevant management board decision referred to in paragraph 4 of this Article, the Member State concerned shall inform the Agency about its intention to deploy the technical equipment with the corresponding crew by the end of January of each year. 6. For the purpose of Article 73, the Agency shall develop and ensure the command and control structures for the effective deployment of the standing corps on the territory of third countries. 7. The Agency may recruit a sufficient number of statutory staff, which may account for up to 4 % of the total number of the standing corps set out in Annex I, for supportive or monitoring functions for the establishment of the standing corps, for the planning and management of its operations and for the acquisition of the Agency's own equipment. 8. The staff referred to in paragraph 7 and the staff responsible for the functioning of the ETIAS Central Unit shall not be deployed as members of the teams, but shall nevertheless be counted as category 1 staff for the purposes of Annex I. Article 55 Statutory staff in the standing corps 1. The Agency shall contribute members of its statutory staff (category 1) to the standing corps to be deployed in operational areas as members of the teams with the tasks and powers provided for in Article 82, including the task of operating the Agency's own equipment. 2. When recruiting staff, the Agency shall ensure that only candidates who demonstrate a high level of professionalism, adhere to high ethical values and possess appropriate language skills are selected. 3. In accordance with Article 62(2), following their recruitment, the statutory staff to be deployed as members of the teams shall undergo necessary border-guard or return-related training, including on fundamental rights, as relevant to the profiles of staff decided by the management board in accordance with Article 54(4), taking into account their previously acquired qualifications and professional experience in the relevant areas. The training referred to in the first subparagraph shall be conducted in the framework of dedicated training programmes designed by the Agency, and, on the basis of agreements with selected Member States, implemented in their specialised institutions for training and education, including the Agency's partnership academies in Member States. Adequate training maps shall be designed for each staff member after his or her recruitment to ensure that he or she is always professionally qualified to fulfil border guard or return-related tasks. Training maps shall be regularly updated. The Agency shall cover the full cost of training. Statutory staff who act as technical crew operating the Agency's own equipment shall not need to undergo full border guard or return-related training. 4. Throughout their employment, the Agency shall ensure that its statutory staff discharge their duties as members of the teams in accordance with the highest standards and in full compliance with fundamental rights. 5. On the basis of a proposal from the executive director, the management board shall: (a) establish an appropriate supervisory mechanism to monitor the application of the provisions on use of force by statutory staff, including rules on reporting and specific measures, such as those of a disciplinary nature, with regard to the use of force during deployments; (b) establish rules for the executive director to authorise statutory staff to carry and use weapons in accordance with Article 82 and Annex V, including on mandatory cooperation with the competent national authorities, in particular of the Member State of nationality, the Member State of residence, and the Member State of the initial training; those rules shall also address how the executive director ensures that the conditions for issuing such authorisations continue to be met by statutory staff, in particular as regards handling weapons including the performance of regular shooting tests; (c) establish specific rules to facilitate the storage of weapons, ammunition and other equipment in secured facilities and their transportation to the operational areas. In relation to the rules referred to in point (a) of the first subparagraph of this paragraph, the Commission shall give an opinion on their compliance with the Staff Regulations and Conditions of Employment, in accordance with Article 110(2) of the Staff Regulations. The fundamental rights officer shall be consulted on the proposal from the executive director with regard to those rules. 6. Agency staff who are not qualified to perform border guard or return-related tasks shall only be deployed during joint operations for coordination, monitoring of fundamental rights and other related tasks. They shall not form part of the teams. 7. The statutory staff to be deployed as members of the teams shall be able to perform, in accordance with Article 82, the following tasks requiring executive powers, in accordance with the profiles of staff and relevant training: (a) the verification of the identity and nationality of persons, including consultation of relevant Union and national databases; (b) the authorisation of entry where the entry conditions, as laid down in Article 6 of Regulation (EU) 2016/399, are fulfilled; (c) the refusal of entry in accordance with Article 14 of Regulation (EU) 2016/399; (d) the stamping of travel documents in accordance with Article 11 of Regulation (EU) 2016/399; (e) the issuing or refusing of visas at the border in accordance with Article 35 of Regulation (EC) No 810/2009 of the European Parliament and of the Council (40) and introducing relevant data in the Visa Information System; (f) border surveillance, including patrolling between border crossing points to prevent unauthorised border crossings, to counter cross-border crime and to take measures against persons who have crossed the border illegally, including interception or apprehension; (g) the registering of fingerprints of persons apprehended in connection with the irregular crossing of an external border in Eurodac in accordance with Chapter III of Regulation (EU) No 603/2013 of the European Parliament and of the Council (41); (h) liaising with third countries with a view to identifying and obtaining travel documents for returnees; (i) escorting third-country nationals subject to forced-return procedures. Article 56 Member States' participation in the standing corps through long-term secondment 1. The Member States shall contribute to the standing corps by seconding operational staff to the Agency as members of the teams (category 2). The duration of individual secondments shall be 24 months. With the agreement of the home Member State and the Agency, individual secondments may be prolonged once for another 12 or 24 months. In order to facilitate the implementation of the financial support system referred to in Article 61, secondments shall, as a general rule, start at the beginning of a calendar year. 2. Each Member State shall be responsible for ensuring the continuous contribution of operational staff as seconded members of the teams in accordance with Annex II. The payment of costs incurred by staff deployed under this Article shall be made in accordance with the rules adopted pursuant to Article 95(6). 3. The operational staff seconded to the Agency shall have the tasks and powers of the members of the teams in accordance with Article 82. The Member State that has seconded those operational staff shall be considered to be their home Member State. During the secondment, the locations and duration of the deployments of seconded members of the teams shall be decided by the executive director in accordance with the operational needs. The Agency shall ensure the continuous training of the operational staff during their secondment. 4. By 30 June of each year, each Member State shall indicate the candidates for secondment among their operational staff in accordance with the specific numbers and profiles of staff decided by the management board for the following year as referred to in Article 54(4). The Agency shall verify whether the operational staff proposed by Member States correspond to the defined profiles of staff and possess the necessary language skills. By 15 September of each year, the Agency shall accept the proposed candidates or, in cases of non-compliance with the required profiles, insufficient language skills, misconduct or infringement of the applicable rules during previous deployments, shall refuse the candidates in question and request that the Member State propose other candidates for secondment. 5. Where, due to force majeure, an individual operational staff member cannot be seconded or is unable to continue his or her secondment, the Member State concerned shall ensure that that staff member is replaced by another operational staff member having the required profile. Article 57 Member States' participation in the standing corps through short-term deployments 1. In addition to the secondments under Article 56, by 30 June of each year, the Member States shall contribute to the standing corps by nominating border guards and other relevant staff to the preliminary national list of available operational staff for short-term deployments (category 3) in accordance with the contributions set out in Annex III and in accordance with the specific numbers and profiles of staff decided by the management board for the following year as referred to in Article 54(4). The preliminary national lists of nominated operational staff shall be communicated to the Agency. The final composition of the annual list shall be confirmed to the Agency after the conclusion of the annual bilateral negotiations by 1 December of that year. 2. Each Member State shall ensure that nominated operational staff are available at the request of the Agency in accordance with the arrangements set out in this Article. Each staff member shall be available for a period of up to four months within a calendar year. However, Member States may decide to deploy an individual staff member beyond four months. Such an extension shall be counted as a separate contribution of that Member State for the same profile or another required profile if the staff member possesses the necessary skills. The payment of the costs incurred by staff deployed under this Article shall be made in accordance with the rules adopted pursuant to Article 45(2). 3. The operational staff deployed under this Article shall have the tasks and powers of the members of the teams in accordance with Article 82. 4. The Agency may verify whether the operational staff nominated for short-term deployments by Member States correspond to the defined profiles of staff and possess the necessary language skills. The Agency shall refuse nominated operational staff in cases of insufficient language skills, misconduct or infringement of the applicable rules during previous deployments. The Agency shall also refuse nominated operational staff in the event of non-compliance with the required profiles unless the operational staff member in question qualifies for another profile allocated to that Member State. In the event of the refusal of a staff member by the Agency, the Member State concerned shall ensure that that staff member is replaced by another operational staff member having the required profile. 5. By 31 July of each year, the Agency shall request that Member States contribute specific individual operational staff members for deployment as part of joint operations for the following year within the required numbers and profiles. The periods of individual deployment shall be decided in the annual bilateral negotiations and agreements between the Agency and Member States. 6. Following the annual bilateral negotiations, Member States shall make the operational staff from the national lists referred to in paragraph 1 available for specific deployments within the numbers and profiles specified in the request of the Agency. 7. Where, due to force majeure, an individual operational staff member cannot be deployed in accordance with the agreements, the Member State concerned shall ensure that such staff member is replaced by another staff member from the list with the required profile. 8. In the event of an increased need for the reinforcement of an ongoing joint operation, a need to launch a rapid border intervention or a new joint operation not specified in the relevant annual work programme or in the corresponding result of annual bilateral negotiations, the deployment shall be carried out within the limits set out in Annex III. The executive director shall inform the Member States without delay about the additional needs by indicating possible numbers and profiles of operational staff to be provided by each Member State. Once an amended operational plan or, where relevant, a new operational plan is agreed upon by the executive director and the host Member State, the formal request for the number and profiles of operational staff shall be made by the executive director. The members of the teams shall be deployed from each Member State within 20 working days from that formal request without prejudice to Article 39. 9. Where the risk analysis or any available vulnerability assessment shows that a Member State is faced with a situation that would substantially affect the discharge of its national tasks, that Member State shall contribute operational staff in accordance with the requests referred to in paragraph 5 or 8 of this Article. However, those contributions shall not cumulatively exceed half of that Member State's contribution for the year in question as set out in Annex III. Where a Member State invokes such an exceptional situation, it shall provide comprehensive reasons and information on the situation to the Agency in writing, the content of which shall be included in the report referred to in Article 65. 10. The duration of the deployment for a specific operation shall be determined by the home Member State but in any event shall not be less than 30 days, except where the operation of which the deployment is a part has a duration shorter than 30 days. 11. The technical crew taken into account for the contributions of Member States in accordance with Article 54(5) shall only be deployed in accordance with the agreements arising from the annual bilateral negotiations for the corresponding items of technical equipment referred to Article 64(9). By way of derogation from paragraph 1 of this Article, Member States shall include in their annual lists the technical crew referred to in the first subparagraph of this paragraph only after the conclusion of the annual bilateral negotiations. Member States may adjust the relevant annual lists in the event of any changes of the technical crew during the year in question. Member States shall notify those changes to the Agency. The verification referred to in paragraph 4 of this Article shall not concern the competence to operate the technical equipment. Crew members having exclusively technical duties shall only be indicated by function on national annual lists. The duration of deployment of technical crews shall be determined in accordance with Article 64. Article 58 Member States' participation in the standing corps through the reserve for rapid reaction 1. The Member States shall contribute operational staff to the standing corps by means of a reserve for rapid reaction (category 4) to be activated for rapid border interventions in accordance with Article 37(2) and Article 39, provided that the operational staff in category 1, 2 and 3 have already been fully deployed for the rapid border intervention in question. 2. Each Member State shall be responsible for ensuring that operational staff are available in the numbers and with the corresponding profiles decided by the management board for the following year as referred to in Article 54(4), at the request of the Agency within the limits set out in Annex IV and in accordance with the arrangements set out in this Article. Each operational staff member shall be available for a period of up to four months within a calendar year. 3. The specific deployments in the framework of rapid border interventions from the reserve for rapid reaction shall take place in accordance with Article 39(11) and (13). Article 59 Review of the standing corps 1. By 31 December 2023, in particular on the basis of the reports referred to in Article 62(10) and Article 65, the Commission shall present to the European Parliament and to the Council a review of the overall number and composition of the standing corps, including the size of individual Member States' contributions to the standing corps, as well as of the expertise and professionalism of the standing corps and of the training it receives. The review shall also examine whether it is necessary to maintain the reserve for rapid reaction as part of the standing corps. The review shall describe and take into account existing and potential operational needs for the standing corps covering rapid reaction capacities, significant circumstances affecting the capability of Member States to contribute to the standing corps and the evolution of the statutory staff as regards the contribution of the Agency to the standing corps. 2. By 29 February 2024, the Commission shall, where necessary, submit appropriate proposals to amend Annexes I, II, III and IV. Where the Commission does not submit a proposal, it shall explain the reasons therefor. Article 60 Antenna offices 1. Subject to an agreement with the host Member State or the explicit inclusion of this possibility in the status agreement concluded with the host third country, the Agency may establish antenna offices on the territory of that Member State or third country in order to facilitate and improve coordination of operational activities, including in the field of return, organised by the Agency in that Member State, in the neighbouring region, or in that third country and in order to ensure the effective management of the human and technical resources of the Agency. The antenna offices shall be established in accordance with operational needs for the period of time necessary for the Agency to carry out significant operational activities in that specific Member State, in the neighbouring region, or in the third country concerned. That period of time may be prolonged, if necessary. Before an antenna office is established, all budgetary consequences shall be carefully assessed and calculated and the relevant amounts shall be budgeted in advance. 2. The Agency and the host Member State or host third country in which the antenna office is established shall make the necessary arrangements to provide the best possible conditions needed to fulfil the tasks assigned to the antenna office. The place of employment for the staff working in antenna offices shall be set in accordance with Article 95(2). 3. The antenna offices shall, where applicable: (a) provide operational and logistical support and ensure the coordination of Agency's activities in the operational areas concerned; (b) provide operational support to the Member State or the third country in the operational areas concerned; (c) monitor the activities of the teams and regularly report to the Agency's headquarters; (d) cooperate with the host Member State or host third country on all issues related to the practical implementation of the operational activities organised by the Agency in that Member State or third country, including any additional issues that might have occurred in the course of these activities; (e) support the coordinating officer referred to in Article 44 in his or her cooperation with the participating Member States on all issues related to their contribution to the operational activities organised by the Agency and, where necessary, liaise with the Agency's headquarters; (f) support the coordinating officer and fundamental rights monitors assigned to monitor an operational activity in facilitating, where necessary, the coordination and communication between the Agency's teams and the relevant authorities of the host Member State or host third country as well any relevant tasks; (g) organise logistical support relating to the deployment of the members of the teams and the deployment and use of technical equipment; (h) provide all other logistical support regarding the operational area for which a given antenna office is responsible, with a view to facilitating the smooth running of the operational activities organised by the Agency; (i) support the Agency's liaison officer, without prejudice to his or her tasks and functions referred to in Article 31, in identifying any current or future challenges for the border management of the area for which a given antenna office is responsible, for the implementation of the return acquis and regularly report to the Agency's headquarters; (j) ensure the effective management of the Agency's own equipment in the areas covered by its activities, including the possible registration and long-term maintenance of that equipment and any logistical support needed. 4. Each antenna office shall be managed by a representative of the Agency appointed by the executive director as a head of an antenna office. The head of the antenna office shall oversee the overall work of the office and shall act as its single point of contact with the Agency's headquarters. 5. On the basis of a proposal from the executive director, the management board shall decide on the establishing, composition, duration and, where needed, possible prolongation of the duration of the operation of an antenna office taking into account the opinion of the Commission and the agreement of the host Member State or the host third country. 6. The host Member State shall provide the Agency with assistance to ensure operational capacity. 7. The executive director shall report to the management board on a quarterly basis on the activities of antenna offices. The activities of the antenna offices shall be described in a separate section of the annual activity report. Article 61 Financial support for the development of the standing corps 1. Member States shall be entitled to receive funding on a yearly basis in the form of financing not linked to costs, in order to support the development of human resources to secure their contributions to the standing corps as set out in Annexes II, III and IV, in accordance with point (a) of Article 125(1) of Regulation (EU, Euratom) 2018/1046. That financing shall be payable after the end of the year concerned and upon fulfilment of conditions laid down in paragraphs 3 and 4 of this Article. That financing shall be based on a reference amount as set in paragraph 2 of this Article and shall amount to, where applicable: (a) 100 % of the reference amount multiplied by the number of operational staff indicated for the year N + 2 for secondment in accordance with Annex II; (b) 37 % of the reference amount multiplied by the number of operational staff effectively deployed in accordance with Article 57 within the limit set in Annex III and in accordance with Article 58 within the limit set in Annex IV, as applicable; (c) a one-off payment of 50 % of the reference amount multiplied by the number of operational staff recruited by the Agency as statutory staff; that payment shall apply to staff departing from national services, being in active service no longer than 15 years at the time of recruitment by the Agency. 2. The reference amount shall be equivalent to the annual basic salary for a contract agent in function group III, grade 8, step 1 as set out in Article 93 of the Conditions of Employment and subject to a correction co-efficient applicable in the Member State concerned. 3. The annual payment of the amount referred to in point (a) of paragraph 1 of this Article shall only become due provided that the Member States increase their respective overall national border guard staffing accordingly through the recruitment of new staff in the period concerned. The relevant information for the purpose of reporting shall be provided to the Agency in the annual bilateral negotiations and shall be verified through the vulnerability assessment in the following year. The annual payment of the amount referred to in point (b) of paragraph 1 of this Article shall be due in full in relation to the number of staff effectively deployed for a consecutive or non-consecutive period of four months in accordance with Article 57 within the limit set in Annex III and in accordance with Article 58 within the limit set in Annex IV. For effective deployments referred to in point (b) of paragraph 1 of this Article, the payments shall be calculated on a pro rata basis with a reference period of four months. The Agency shall grant an advance payment linked to the annual payments of the amounts referred to in points (a) and (b) of paragraph 1 of this Article in accordance with the implementing act referred to in paragraph 4 of this Article following the submission of a specific and justified request by the contributing Member State. 4. The Commission shall adopt an implementing act laying down detailed rules for the annual payment and the monitoring of the applicable conditions provided in paragraph 3 of this Article. Those rules shall include arrangements for advanced payments upon fulfilment of the conditions set out in paragraph 3 of this Article, as well as the arrangements for pro-rata calculations, including with respect to cases where the deployment of technical crew would exceptionally exceed the maximum national contributions set out in Annex III. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 122(2). 5. When implementing the financial support under this Article, the Agency and the Member States shall ensure compliance with the principles of co-financing and no double funding. Article 62 Training 1. The Agency shall, taking into account the capability roadmap referred to in Article 9(8), where available, and in cooperation with the appropriate training entities of the Member States, and, where appropriate, EASO, FRA, the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) and the European Union Agency for Law Enforcement Training (CEPOL), develop specific training tools, including specific training in the protection of children and other persons in a vulnerable situation. Training content shall take into account relevant research outcomes and best practices. The Agency shall provide border guards, return specialists, return escorts and other relevant staff who are members of the standing corps as well as forced-return monitors and fundamental rights monitors with specialised training relevant to their tasks and powers. The Agency shall conduct regular exercises with those border guards and other members of the teams in accordance with the specialised training schedule referred to in the annual work programme of the Agency. 2. The Agency shall ensure that, in addition to the training referred to in Article 55(3), all statutory staff to be deployed as members of the teams have received adequate training in relevant Union and international law, including on fundamental rights, access to international protection, guidelines for the purpose of identifying persons seeking protection and directing them towards the appropriate procedures, guidelines for addressing the special needs of children, including unaccompanied minors, victims of trafficking in human beings, persons in need of urgent medical assistance and other particularly vulnerable persons, and, where it is intended that they participate in sea operations, search and rescue, prior to their initial deployment in operational activities organised by the Agency. Such training shall also cover the use of force in accordance with Annex V. 3. For the purpose of paragraph 2, the Agency, on the basis of agreements with selected Member States, shall implement the necessary training programmes in those Member States' specialised institutions for training and education, including the Agency's partnership academies in Member States. The Agency shall ensure that the training follows the common core curricula, is harmonised and fosters mutual understanding and a common culture based on the values enshrined in the Treaties. The Agency shall cover the full cost of training. The Agency, after obtaining the approval of the management board, may set up an Agency training centre to further facilitate the inclusion of a common European culture in the training provided. 4. The Agency shall take the necessary initiatives to ensure that all staff of the Member States who participate in the teams from the standing corps have received the training referred to in the first subparagraph of paragraph 2. 5. The Agency shall take the necessary initiatives to ensure training for staff involved in return-related tasks who are allocated to the standing corps or to the pool referred to in Article 51. The Agency shall ensure that statutory staff and all staff who participate in return operations or return interventions have received training in relevant Union and international law, including on fundamental rights, access to international protection and on referral of vulnerable persons, prior to their participation in operational activities organised by the Agency. 6. The Agency shall establish and further develop common core curricula for the training of border guards and provide training at European level for instructors of the border guards of Member States, including with regard to fundamental rights, access to international protection and relevant maritime law, as well as a common curriculum for the training of staff involved in return-related tasks. The common core curricula shall aim to promote the highest standards and best practices in the implementation of Union border management and return law. The Agency shall draw up the common core curricula after consulting the consultative forum referred to in Article 108 (the ‘consultative forum’) and the fundamental rights officer. Member States shall integrate the common core curricula into the training they provide to their national border guards and staff involved in return-related tasks. 7. The Agency shall also offer additional training courses and seminars on subjects related to external border control and return of third-country nationals for officers of the competent services of Member States and, where appropriate, of third countries. 8. The Agency may organise training activities in cooperation with Member States and third countries on their territory. 9. The Agency shall establish an exchange programme enabling border guards participating in its teams and staff participating in the return intervention teams to acquire knowledge or specific know-how from experience and good practices abroad by working with border guards and staff involved in return-related tasks in a Member State other than their own. 10. The Agency shall establish and further develop an internal quality control mechanism to ensure a high level of training, expertise and professionalism of statutory staff, in particular statutory staff who participate in the operational activities of the Agency. On the basis of the implementation of the quality control mechanism, the Agency shall prepare an annual evaluation report which shall be annexed to the annual activity report. Article 63 Acquisition or leasing of technical equipment 1. The Agency may acquire, either on its own or as co-owner with a Member State, or lease technical equipment to be deployed during joint operations, pilot projects, rapid border interventions, activities in the area of return, including return operations and return interventions, migration management support team deployments or technical assistance projects in accordance with the financial rules applicable to the Agency. 2. On the basis of a proposal from the executive director, the management board shall adopt a comprehensive multiannual strategy on how the Agency's own technical capabilities are to be developed taking into account the multiannual strategic policy cycle for European integrated border management, including the capability roadmap referred to in Article 9(8), where available, and the budgetary resources made available for that purpose in the multiannual financial framework. To ensure compliance with the applicable legal, financial and policy frameworks, the executive director shall only make the proposal after receiving the positive opinion of the Commission. The multiannual strategy shall be accompanied by a detailed implementation plan specifying the timeline for acquisition or leasing, procurement planning and risk mitigation. If the management board, when adopting the strategy and the plan, decides to depart from the opinion of the Commission, it shall provide the Commission with a justification for doing so. Following the adoption of the multiannual strategy, the implementation plan shall become part of the multiannual programming component of the single programing document referred to in point (k) of Article 100(2). 3. The Agency may acquire technical equipment by decision of the executive director in consultation with the management board in accordance with the applicable procurement rules. Any acquisition or leasing of equipment entailing significant costs to the Agency shall be preceded by a thorough needs and cost-benefit analysis. Any expenditure related to such acquisition or leasing shall be provided for in the Agency's budget adopted by the management board. 4. Where the Agency acquires or leases major technical equipment such as aircraft, service vehicles or vessels, the following conditions shall apply: (a) in the case of an acquisition by the Agency or co-ownership, the Agency shall agree with one Member State that that Member State is to provide that the equipment be registered as being on government service in accordance with the applicable law of that Member State, including prerogatives and immunities for such technical equipment under international law; (b) in the case of leasing, the equipment shall be registered in a Member State. 5. On the basis of a model agreement drawn up by the Agency and approved by the management board, the Member State of registration and the Agency shall agree on terms ensuring the operability of the equipment. In the case of co-owned assets, the terms shall also cover the periods of full availability of the assets for the Agency and determine the use of those assets, including specific provisions on rapid deployment during rapid border interventions and the financing of those assets. 6. Where the Agency does not have the required qualified statutory staff, the Member State of registration or the supplier of technical equipment shall provide the necessary experts and technical crew to operate the technical equipment in a legally sound and safe manner in accordance with the model agreement referred to in paragraph 5 of this Article and planned on the basis of the annual bilateral negotiations and agreements referred to in Article 64(9). In such a case, technical equipment owned solely by the Agency shall be made available to the Agency upon its request and the Member State of registration may not invoke the exceptional situation referred to in Article 64(9). When requesting a Member State to provide technical equipment and staff, the Agency shall take into account the particular operational challenges facing that Member State at the time of the request. Article 64 Technical equipment pool 1. The Agency shall set up and keep centralised records of equipment in a technical equipment pool composed of equipment owned either by the Member States or by the Agency and equipment co-owned by the Member States and by the Agency for its operational activities. 2. Equipment solely owned by the Agency shall be fully available for deployment at any time. 3. Equipment co-owned by the Agency at a share of more than 50 % shall also be available for deployment in accordance with an agreement between a Member State and the Agency, concluded in accordance with Article 63(5). 4. The Agency shall ensure the compatibility and interoperability of the equipment listed in the technical equipment pool. 5. For the purposes of paragraph 4, the Agency, in close cooperation with the Member States and the Commission, shall define technical standards for the equipment to be deployed in the activities of the Agency, where necessary. Equipment that is acquired by the Agency, whether as sole or co-owner, and equipment owned by Member States which is listed in the technical equipment pool shall meet those standards. 6. On the basis of a proposal from the executive director taking into account the Agency's risk analysis and the results of vulnerability assessments, the management board shall decide, by 31 March of each year, on the minimum number of items of technical equipment required to meet the needs of the Agency in the following year, in particular as regards carrying out joint operations, migration management support team deployments, rapid border interventions, activities in the area of return, including return operations and return interventions. The Agency's own equipment shall be included in the minimum number of items of technical equipment. That decision shall establish rules relating to the deployment of technical equipment in the operational activities. If the minimum number of items of technical equipment proves to be insufficient to carry out the operational plan agreed for such activities, the Agency shall revise that minimum number on the basis of justified needs and of an agreement with the Member States. 7. The technical equipment pool shall contain the minimum number of items of equipment identified as needed by the Agency per type of technical equipment. The equipment listed in the technical equipment pool shall be deployed during joint operations, migration management support team deployments, pilot projects, rapid border interventions, return operations or return interventions. 8. The technical equipment pool shall include a rapid reaction equipment pool containing a limited number of items of equipment needed for possible rapid border interventions. The contributions of Member States to the rapid reaction equipment pool shall be planned in accordance with the annual bilateral negotiations and agreements referred in paragraph 9 of this Article. For the equipment on the list of the items in that pool, Member States may not invoke the exceptional situation referred to in paragraph 9 of this Article. The Member State concerned shall send the equipment on that list, together with the necessary experts and technical crew, to the destination for deployment as soon as possible, and, in any event, no later than 10 days after the date on which the operational plan is agreed. The Agency shall contribute to this pool with equipment at the Agency's disposal as referred to in Article 63(1). 9. Member States shall contribute to the technical equipment pool. The contribution by Member States to the pool and deployment of the technical equipment for specific operations shall be planned on the basis of annual bilateral negotiations and agreements between the Agency and Member States. In accordance with those agreements and to the extent that it forms part of the minimum number of items of technical equipment for a given year, Member States shall make their technical equipment available for deployment at the request of the Agency, unless they are faced with an exceptional situation substantially affecting the discharge of national tasks. If a Member State invokes such an exceptional situation, it shall provide, in writing, comprehensive reasons and information on the situation to the Agency, the content of which shall be included in the report referred to in Article 65(1). The Agency's request shall be made at least 45 days before the intended deployment of major technical equipment and 30 days before the intended deployment of other equipment. The contributions to the technical equipment pool shall be reviewed annually. 10. On the basis of a proposal from the executive director, the management board shall decide, on a yearly basis, on the rules relating to technical equipment, including the required overall minimum numbers of items per type of technical equipment and the terms for the deployment and reimbursement of costs as well as on the limited number of items of technical equipment for a rapid reaction equipment pool. For budgetary purposes that decision shall be taken by the management board by 31 March of each year. 11. Where a rapid border intervention takes place, Article 39(15) shall apply accordingly. 12. Where unexpected needs for technical equipment for a joint operation or a rapid border intervention arise after the minimum number of items of technical equipment has been set and those needs cannot be met from the technical equipment pool or the rapid reaction equipment pool, Member States shall, where possible, on an ad hoc basis, make the necessary technical equipment available for deployment to the Agency upon its request. 13. The executive director shall regularly report to the management board on the composition and the deployment of equipment which is part of the technical equipment pool. Where the minimum number of items of technical equipment required in the pool has not been met, the executive director shall inform the management board without delay. The management board shall take a decision on the prioritisation of the deployment of the technical equipment urgently and take the appropriate steps to remedy the shortfall. The management board shall inform the Commission of the shortfall and the steps it has taken. The Commission shall subsequently inform the European Parliament and the Council thereof and of its own assessment. 14. Member States shall register in the technical equipment pool all the means of transport and operating equipment purchased under the specific actions of the Internal Security Fund in accordance with Article 7(1) of Regulation (EU) No 515/2014 of the European Parliament and of the Council (42) or, where relevant, any other future dedicated Union funding made available to the Member States with the clear objective of increasing the operational capacity of the Agency. That technical equipment shall form part of the minimum number of items of technical equipment for a given year. Upon a request made by the Agency in the framework of the annual bilateral negotiations, the Member States shall make technical equipment co-financed under the specific actions of the Internal Security Fund or by any other future dedicated Union funding as specified in the first subparagraph of this paragraph available for deployment to the Agency. Each item of equipment shall be made available for a period of up to four months as planned in the annual bilateral negotiations. Member States may decide to deploy an item of equipment beyond four months. In the case of an operational activity referred to in Article 39 or 42 of this Regulation, Member States may not invoke the exceptional situation referred to in paragraph 9 of this Article. 15. The Agency shall manage the records of the technical equipment pool as follows: (a) classification by type of equipment and by type of operation; (b) classification by owner (Member State, Agency, other); (c) overall numbers of items of equipment required; (d) crew requirements if applicable; (e) other information, such as registration details, transportation and maintenance requirements, national applicable export regimes, technical instructions, or other information relevant to appropriate use of the equipment; (f) indication as to whether an item of equipment was financed from Union funding. 16. The Agency shall finance 100 % of the deployment of technical equipment which forms part of the minimum number of items of technical equipment provided by a given Member State for a given year. The deployment of technical equipment which does not form part of the minimum number of items of technical equipment shall be co-financed by the Agency, up to a maximum of 100 % of the eligible expenses, taking into account the particular circumstances of the Member States deploying such technical equipment. Article 65 Reporting on the Agency's capabilities 1. On the basis of a proposal from the executive director, the management board shall adopt and submit to the European Parliament, to the Council and to the Commission an annual report on the implementation of Articles 51, 55, 56, 57, 58, 63 and 64 (‘annual implementation report’). 2. The annual implementation report shall include, in particular: (a) the number of staff that each Member State has committed to the standing corps, including through the reserve for rapid reaction, and to the pool of forced-return monitors; (b) the number of statutory staff that the Agency has committed to the standing corps; (c) the number of staff actually deployed from the standing corps, by each Member State and by the Agency per profile in the previous year; (d) the number of items of technical equipment that each Member State and the Agency has committed to the technical equipment pool; (e) the number of items of technical equipment deployed by each Member State and the Agency in the previous year from the technical equipment pool; (f) commitments to and deployments of equipment from the rapid reaction equipment pool; (g) the development of the Agency's own human and technical capabilities. 3. The annual implementation report shall list the Member States that invoked the exceptional situation referred to in Article 57(9) and Article 64(9) in the previous year and include the reasons and information provided by the Member State concerned. 4. To ensure transparency, the executive director shall inform the management board on a quarterly basis on the elements listed in paragraph 2 in relation to the ongoing year. Article 66 Research and innovation 1. The Agency shall proactively monitor and contribute to research and innovation activities relevant for European integrated border management including the use of advanced border control technology, taking into account the capability roadmap referred to in Article 9(8). The Agency shall disseminate the results of that research to the European Parliament, to the Member States and to the Commission in accordance with Article 92. It may use those results as appropriate in joint operations, rapid border interventions, return operations and return interventions. 2. The Agency, taking into account the capability roadmap referred to in Article 9(8), shall assist the Member States and the Commission in identifying key research themes. The Agency shall assist Member States and the Commission in drawing up and implementing the relevant Union framework programmes for research and innovation activities. 3. The Agency shall implement the parts of the Framework Programme for Research and Innovation which relate to border security. For that purpose, and where the Commission has delegated the relevant powers to it, the Agency shall have the following tasks: (a) managing some stages of programme implementation and some phases in the lifetime of specific projects on the basis of the relevant work programmes adopted by the Commission; (b) adopting the instruments of budget execution for revenue and expenditure and carrying out all the operations necessary for the management of the programme; (c) providing support in programme implementation. 4. The Agency may plan and implement pilot projects regarding matters covered by this Regulation. 5. The Agency shall make public information on its research projects, including demonstration projects, the cooperation partners involved and the project budget. SECTION 10 The European Travel Information and Authorisation System (ETIAS) Article 67 ETIAS Central Unit The Agency shall ensure the setting-up and operation of an ETIAS Central Unit as referred to in Article 7 of Regulation (EU) 2018/1240. SECTION 11 Cooperation Article 68 Cooperation of the Agency with Union institutions, bodies, offices, agencies, and international organisations 1. The Agency shall cooperate with Union institutions, bodies, offices and agencies, and may cooperate with international organisations, within their respective legal frameworks, and shall make use of existing information, resources and systems available in the framework of EUROSUR. In accordance with the first subparagraph, the Agency shall cooperate, in particular, with: (a) the Commission and the European External Action Service (EEAS); (b) Europol; (c) EASO; (d) FRA; (e) Eurojust; (f) the European Union Satellite Centre; (g) EFCA and EMSA; (h) eu-LISA; (i) the European Union Aviation Safety Agency (EASA) and the Network Manager of the European Air Traffic Management Network (EATMN); (j) CSDP missions and operations, in accordance with their mandates, with a view to ensuring the following: (i) the promotion of European integrated border management standards; (ii) situational awareness and risk analysis. The Agency may also cooperate with the following international organisations, as relevant to its tasks, within their respective legal frameworks: (a) the United Nations through its relevant offices, agencies, organisations and other entities, in particular the Office of the United Nations High Commissioner for Refugees, the Office of the High Commissioner for Human Rights, the International Organization for Migration, the United Nations Office on Drugs and Crime and the International Civil Aviation Organization; (b) the International Criminal Police Organization (Interpol); (c) the Organisation for Security and Cooperation in Europe; (d) the Council of Europe and the Commissioner for Human Rights of the Council of Europe; (e) the Maritime Analysis and Operations Centre — Narcotics (MAOC-N). 2. The cooperation referred to in paragraph 1 shall take place within the framework of working arrangements concluded with the entities referred to in paragraph 1. Such arrangements shall be subject to the Commission's prior approval. The Agency shall inform the European Parliament and the Council of any such arrangements. 3. As regards the handling of classified information, the working arrangements referred to in paragraph 2 shall provide that the Union body, office or agency or international organisation concerned comply with security rules and standards equivalent to those applied by the Agency. An assessment visit shall be conducted prior to the conclusion of an arrangement and the Commission shall be informed of the outcome of the assessment visit. 4. Although outside the scope of this Regulation, the Agency shall also engage in cooperation with the Commission and, where relevant, with Member States and the EEAS in activities relating to the customs area, including risk management, where those activities support each other. That cooperation shall be without prejudice to the existing competence of the Commission, of the High Representative of the Union for Foreign Affairs and Security Policy and of the Member States. 5. Union institutions, bodies, offices, agencies, and the international organisations referred to in paragraph 1, shall use information received from the Agency only within the limits of their competence and insofar as they respect fundamental rights, including data protection requirements. Any transmission of personal data processed by the Agency to other Union institutions, bodies, offices and agencies under points (c) and (d) of Article 87(1) shall be subject to specific working arrangements regarding the exchange of personal data. The working arrangements referred to in the second subparagraph shall include a provision ensuring that personal data transmitted to Union institutions, bodies, offices and agencies by the Agency may be processed for another purpose only if authorised by the Agency and if compatible with the initial purpose for which the data were collected and transmitted by the Agency. Those Union institutions, bodies, offices and agencies shall keep written records of a case-by-case compatibility assessment. Any transfer of personal data by the Agency to international organisations under point (c) of Article 87(1) shall be in accordance with the data protection provisions laid down in Section 2 of Chapter IV. In particular, the Agency shall ensure that any working arrangement concluded with international organisations regarding the exchange of personal data under point (c) of Article 87(1) complies with Chapter V of Regulation (EU) 2018/1725 and is subject to the authorisation of the European Data Protection Supervisor, where provided for by that Regulation. The Agency shall ensure that personal data transferred to international organisations are only processed for the purposes for which they were transferred. 6. The exchange of information between the Agency and Union institutions, bodies, offices and agencies, and international organisations referred to in paragraph 1, shall be conducted via the communication network referred to in Article 14 or via other accredited information exchange systems which fulfil the criteria of availability, confidentiality and integrity. Article 69 European cooperation on coast guard functions 1. Without prejudice to EUROSUR, the Agency shall, in cooperation with EFCA and EMSA, support national authorities carrying out coast guard functions at national and Union level and, where appropriate, at international level by: (a) sharing, fusing and analysing information available in ship reporting systems and other information systems hosted by or accessible to those agencies, in accordance with their respective legal bases and without prejudice to the ownership of data by Member States; (b) providing surveillance and communication services based on state-of-the-art technology, including space-based and ground infrastructure and sensors mounted on any kind of platform; (c) building capacity by drawing up guidelines and recommendations and by establishing best practices as well as by providing training and exchange of staff; (d) enhancing the exchange of information and cooperation on coast guard functions, including by analysing operational challenges and emerging risks in the maritime domain; (e) sharing capacity by planning and implementing multipurpose operations and by sharing assets and other capabilities, to the extent that those activities are coordinated by those agencies and are agreed to by the competent authorities of the Member States concerned. 2. The precise forms of cooperation on coast guard functions between the Agency, EFCA and EMSA shall be determined in a working arrangement in accordance with their respective mandates and with the financial rules applicable to those agencies. Such an arrangement shall be approved by the management board of the Agency and the administrative boards of EFCA and EMSA. The Agency, EFCA and EMSA shall use information received in the context of their cooperation only within the limits of their legal framework and in compliance with fundamental rights, including data protection requirements. 3. The Commission shall, in close cooperation with the Member States, the Agency, EFCA and EMSA, make available a practical handbook on European cooperation on coast guard functions. That handbook shall contain guidelines, recommendations and best practices for the exchange of information. The Commission shall adopt the handbook in the form of a recommendation. Article 70 Cooperation with Ireland and the United Kingdom 1. The Agency shall facilitate operational cooperation of the Member States with Ireland and the United Kingdom in specific activities. 2. For the purposes of EUROSUR, the exchange of information and cooperation with Ireland and the United Kingdom may take place on the basis of bilateral or multilateral agreements between Ireland or the United Kingdom respectively and one or several neighbouring Member States or through regional networks based on those agreements. The national coordination centres shall be the contact points for the exchange of information with the corresponding authorities of Ireland and the United Kingdom within EUROSUR. 3. The agreements referred to in paragraph 2 shall be limited to the following exchanges of information between a national coordination centre and the corresponding authority of Ireland or the United Kingdom: (a) information contained in the national situational picture of the Member State, to the extent such information was transmitted to the Agency for the purposes of the European situational picture; (b) information collected by Ireland or the United Kingdom which is relevant for the purposes of the European situational picture; (c) information as referred to in Article 25(5). 4. Information provided in the context of EUROSUR by the Agency or by a Member State which is not party to an agreement as referred to in paragraph 2 shall not be shared with Ireland or the United Kingdom without the prior approval of the Agency or that Member State. The Member States and the Agency shall be bound by the refusal to share that information with Ireland or the United Kingdom. 5. The onward transmission or other communication of information exchanged under this Article to third countries or to third parties shall be prohibited. 6. The agreements referred to in paragraph 2 shall include provisions on the financial costs arising from the participation of Ireland or the United Kingdom in the implementation of those agreements. 7. Support to be provided by the Agency pursuant to points (n), (o) and (p) of Article 10(1) shall cover the organisation of return operations of Member States in which Ireland or the United Kingdom also participates. 8. The application of this Regulation to the borders of Gibraltar shall be suspended until the date on which an agreement is reached on the scope of the measures concerning the crossing by persons of the external borders. Article 71 Cooperation with third countries 1. The Member States and the Agency shall cooperate with third countries for the purpose of European integrated border management and migration policy in accordance with point (g) of Article 3(1). 2. On the basis of the policy priorities set out in accordance with Article 8(4), the Agency shall provide technical and operational assistance to third countries within the framework of the external action policy of the Union, including with regard to the protection of fundamental rights and personal data and with regard to the principle of non-refoulement. 3. The Agency and Member States shall comply with Union law, including norms and standards which form part of the Union acquis, including where cooperation with third countries takes place on the territory of those third countries. 4. The establishment of cooperation with third countries shall serve to promote European integrated border management standards. Article 72 Cooperation of Member States with third countries 1. Member States may cooperate at an operational level with one or more third countries in relation to the areas covered by this Regulation. Such cooperation may include the exchange of information and may take place on the basis of bilateral or multilateral agreements, other forms of arrangements, or through regional networks established on the basis of those agreements. 2. When concluding the bilateral and multilateral agreements referred to in paragraph 1 of this Article, Member States may include provisions concerning the exchange of information and cooperation for the purposes of EUROSUR in accordance with Articles 75 and 89. 3. The bilateral and multilateral agreements and other forms of arrangements referred to in paragraph 1 shall comply with Union and international law on fundamental rights and on international protection, including the Charter, the European Convention for the Protection of Human Rights and Fundamental Freedoms and the 1951 Convention relating to the Status of Refugees, the 1967 Protocol thereto, and in particular the principle of non-refoulement. When implementing such agreements and arrangements, Member States shall assess and take into account the general situation in the third country on a regular basis, and shall have regard to Article 8. Article 73 Cooperation between the Agency and third countries 1. The Agency may cooperate, to the extent required for the fulfilment of its tasks, with the authorities of third countries competent in matters covered by this Regulation. The Agency shall comply with Union law, including norms and standards which form part of the Union acquis, including where cooperation with third countries takes place on the territory of those third countries. 2. When cooperating with the authorities of third countries, as referred to in paragraph 1 of this Article, the Agency shall act within the framework of the external action policy of the Union, including with regard to the protection of fundamental rights and personal data, the principle of non-refoulement, the prohibition of arbitrary detention and the prohibition of torture and inhuman or degrading treatment or punishment, with the support of, and in coordination with, Union delegations and, where relevant, CSDP missions and operations in accordance with point (j) of the second subparagraph of Article 68(1). 3. In circumstances requiring the deployment of border management teams from the standing corps to a third country where the members of the teams will exercise executive powers, a status agreement drawn up on the basis of the model status agreement referred to in Article 76(1) shall be concluded by the Union with the third country concerned on the basis of Article 218 of the Treaty on the Functioning of the European Union (TFEU). The status agreement shall cover all aspects that are necessary for carrying out the actions. It shall set out, in particular, the scope of the operation, provisions on civil and criminal liability, the tasks and powers of the members of the teams, measures related to the establishment of an antenna office and practical measures related to the respect of fundamental rights. The status agreement shall ensure that fundamental rights are fully respected during those operations and shall provide for a complaints mechanism. The European Data Protection Supervisor shall be consulted on the provisions of the status agreement related to the transfer of data if those provisions differ substantially from the model status agreement. 4. Where available, the Agency shall also act within the framework of working arrangements concluded with the authorities of third countries referred to in paragraph 1 of this Article in accordance with Union law and policy, in accordance with Article 76(4). The working arrangements referred to in the first subparagraph of this paragraph shall specify the scope, nature and purpose of the cooperation and shall be related to the management of operational cooperation. Such working arrangements may include provisions concerning the exchange of sensitive non-classified information and cooperation in the framework of EUROSUR in accordance with Article 74(3). The Agency shall ensure that the third countries to which information is transferred only process that information for the purposes for which it was transferred. Any working arrangements on exchanging classified information shall be concluded in accordance with Article 76(4) of this Regulation. The Agency shall request prior authorisation from the European Data Protection Supervisor where those working arrangements provide for the transfer of personal data and where provided for by Regulation (EU) 2018/1725. 5. The Agency shall contribute to the implementation of the Union external policy on return and readmission within the framework of the external action policy of the Union and regarding matters covered by this Regulation. 6. The Agency may receive Union funding in accordance with the provisions of the relevant instruments supporting third countries and activities relating to them. It may launch and finance technical assistance projects in third countries regarding matters covered by this Regulation and in accordance with the financial rules applicable to the Agency. Such projects shall be included in the single programming document referred to in Article 102. 7. The Agency shall inform the European Parliament, the Council and the Commission of activities conducted pursuant to this Article and, in particular, of the activities related to technical and operational assistance in the field of border management and return in third countries, and the deployment of liaison officers, and shall provide them with detailed information on compliance with fundamental rights. The Agency shall make public the agreements, working arrangements, pilot projects and technical assistance projects with third countries in accordance with Article 114(2). 8. The Agency shall include an assessment of the cooperation with third countries in its annual reports. Article 74 Technical and operational assistance provided by the Agency to third countries 1. The Agency may coordinate operational cooperation between Member States and third countries and provide technical and operational assistance to third countries in the context of European integrated border management. 2. The Agency may carry out actions related to European integrated border management on the territory of a third country subject to the agreement of that third country. 3. Operations on the territory of a third country shall be included in the annual work programme adopted by the management board in accordance with Article 102, and shall be carried out on the basis of an operational plan agreed between the Agency and the third country concerned and in consultation with the participating Member States. Where a Member State or Member States neighbour the third country or border the operational area of the third country, the operational plan and any amendments thereto shall be subject to the agreement of that Member State or those Member States. Articles 38, 43, 46, 47 and 54 to 57 shall apply mutatis mutandis to deployments in third countries. 4. The executive director shall ensure the security of the staff deployed in third countries. For the purpose of the first subparagraph, Member States shall inform the executive director of any concern related to the security of their nationals should they be deployed on the territory of certain third countries. Where the security of any staff member deployed in third countries cannot be guaranteed, the executive director shall take appropriate measures by suspending or terminating the corresponding aspects of the technical and operational assistance provided by the Agency to that third country. 5. Without prejudice to the deployment of the members of the standing corps in accordance with Articles 54 to 58, the participation of Member States in operations on the territory of third countries shall be voluntary. In addition to the relevant mechanism referred to in Article 57(9) and paragraph 4 of this Article, where the security of its participating staff cannot be guaranteed to the satisfaction of the Member State, that Member State may opt out of its respective contribution to the operation in the third country in question. Where a Member State invokes such an exceptional situation, it shall provide comprehensive reasons and information on the situation to the Agency in writing, the content of which shall be included in the report referred to in Article 65. Such reasons and information shall be provided during the annual bilateral negotiations or no later than 21 days prior to the deployment. The deployment of staff seconded in accordance with Article 56 shall be subject to the consent of the home Member Sate communicated upon notification by the Agency and no later than 21 days prior to the deployment. 6. Operational plans as referred to in paragraph 3 may include provisions concerning the exchange of information and cooperation for the purpose of EUROSUR in accordance with Articles 75 and 89. Article 75 Exchange of information with third countries in the framework of EUROSUR 1. The national coordination centres and, where relevant, the Agency shall be the contact points for the exchange of information and cooperation with third countries for the purposes of EUROSUR. 2. The provisions concerning exchange of information and cooperation for the purposes of EUROSUR contained in the bilateral or multilateral agreements referred to in Article 72(2) shall address: (a) the specific situational pictures shared with third countries; (b) the data originating from third countries which can be shared in the European situational picture and the procedures for sharing those data; (c) the procedures and conditions by which EUROSUR fusion services can be provided to third countries' authorities; (d) the detailed rules regarding cooperation and the exchange of information with third-country observers for the purpose of EUROSUR. 3. Information provided in the context of EUROSUR by the Agency or by a Member State which is not party to an agreement as referred to in Article 72(1) shall not be shared with a third country under that agreement without the prior approval of the Agency or of that Member State. The Member States and the Agency shall be bound by the refusal to share that information with the third country concerned. Article 76 Role of the Commission with regard to cooperation with third countries 1. The Commission, after consulting the Member States, the Agency, FRA and the European Data Protection Supervisor, shall draw up a model status agreement for actions conducted on the territory of third countries. 2. The Commission, in cooperation with the Member States and the Agency, shall draw up model provisions for the exchange of information in the framework of EUROSUR in accordance with Articles 70(2) and 72(2). The Commission, after consulting the Agency and other relevant Union bodies, offices or agencies, including FRA and the European Data Protection Supervisor, shall draw up a model for the working arrangements referred to in Article 73(4). That model shall include provisions related to fundamental rights and data protection safeguards addressing practical measures. 3. Before a new bilateral or multilateral agreement as referred to in Article 72(1) is concluded, the Member States concerned shall notify the Commission of the draft provisions related to border management and return. The Member States concerned shall notify the provisions of such existing and new bilateral and multilateral agreements related to border management and return to the Commission, which shall inform the Council and the Agency thereof. 4. Before the management board approves any working arrangements between the Agency and competent authorities of third countries, the Agency shall notify them to the Commission, which shall give its prior approval. Before any such working arrangement is concluded, the Agency shall provide the European Parliament with detailed information as regards the parties to the working arrangement and its envisaged content. 5. The Agency shall notify the operational plans referred to in Article 74(3) to the Commission. Any decision to deploy liaison officers to third countries in accordance with Article 77 shall be subject to receiving the prior opinion of the Commission. The European Parliament shall be kept fully informed of those activities without delay. Article 77 Liaison officers in third countries 1. The Agency may deploy experts from its statutory staff and other experts as liaison officers, who should enjoy the highest possible protection when carrying out their duties in third countries. They shall form part of the local or regional cooperation networks of immigration liaison officers and security experts of the Union and of the Member States, including the network set up pursuant to Regulation (EU) 2019/1240. By decision of the management board, the Agency may lay down the specific profiles of liaison officers, depending on the operational needs with regard to the third country concerned. 2. Within the framework of the external action policy of the Union, priority for the deployment of liaison officers shall be given to those third countries which, on the basis of a risk analysis, constitute a country of origin or transit regarding illegal immigration. The Agency may receive liaison officers posted by those third countries on a reciprocal basis. The management board shall, on the basis of a proposal from the executive director, adopt the list of priorities on a yearly basis. The deployment of liaison officers shall be approved by the management board following the opinion of the Commission. 3. The tasks of the Agency's liaison officers shall include establishing and maintaining contacts with the competent authorities of the third country to which they are assigned with a view to contributing to the prevention of and fight against illegal immigration and the return of returnees, including by providing technical assistance in the identification of third-country nationals and the acquisition of travel documents. Such tasks shall be carried out in compliance with Union law and shall respect fundamental rights. The Agency's liaison officers shall coordinate closely with Union delegations, with Member States in accordance with Regulation (EU) 2019/1240 and, where relevant, with CSDP missions and operations as set out in point (j) of the second subparagraph of Article 68(1). Wherever possible, they shall have their offices in the same premises as the Union delegations. 4. In third countries where return liaison officers are not deployed by the Agency, the Agency may support a Member State in deploying a return liaison officer to provide support to the Member States, as well as to support the Agency's activities, in accordance with Article 48. Article 78 Observers participating in the Agency's activities 1. The Agency may, with the agreement of the Member States concerned, invite observers of Union institutions, bodies, offices, agencies or international organisations and CSDP missions and operations referred to in point (j) of the second subparagraph of Article 68(1) to participate in its activities, in particular in joint operations and pilot projects, risk analysis and training, to the extent that their presence is in accordance with the objectives of those activities, may contribute to the improvement of cooperation and the exchange of best practices, and does not affect the overall safety and security of those activities. The participation of such observers in risk analysis and training may take place only with the agreement of the Member States concerned. As regards joint operations and pilot projects, the participation of observers shall be subject to the agreement of the host Member State. Detailed rules on the participation of observers shall be included in the operational plan. Those observers shall receive appropriate training from the Agency prior to their participation. 2. The Agency may, with the agreement of the Member States concerned, invite observers from third countries to participate in its activities at the external borders, return operations, return interventions and training, as referred to in Article 62, to the extent that their presence is in accordance with the objectives of those activities, may contribute to improving cooperation and the exchange of best practices, and does not affect the overall safety of those activities or the safety of third-country nationals. Detailed rules on the participation of observers shall be included in the operational plan. Those observers shall receive appropriate training from the Agency prior to their participation. They shall be required to adhere to the codes of conduct of the Agency while participating in its activities. 3. The Agency shall ensure that the presence of observers does not pose any risk related to respect for fundamental rights. CHAPTER III FALSE AND AUTHENTIC DOCUMENTS ONLINE (FADO) Article 79 The Agency shall take over and operate the False and Authentic Documents Online (‘FADO’) system established in accordance with Joint Action 98/700/JHA. CHAPTER IV GENERAL PROVISIONS SECTION 1 General rules Article 80 Protection of fundamental rights and a fundamental rights strategy 1. The European Border and Coast Guard shall guarantee the protection of fundamental rights in the performance of its tasks under this Regulation in accordance with relevant Union law, in particular the Charter, and relevant international law, including the 1951 Convention relating to the Status of Refugees, the 1967 Protocol thereto, the Convention on the Rights of the Child and obligations related to access to international protection, in particular the principle of non-refoulement. For that purpose, the Agency, with the contribution of and subject to the endorsement by the fundamental rights officer, shall draw up, implement and further develop a fundamental rights strategy and action plan, including an effective mechanism for monitoring respect for fundamental rights in all the activities of the Agency. 2. In the performance of its tasks, the European Border and Coast Guard shall ensure that no person, in contravention of the principle of non-refoulement, be forced to disembark in, forced to enter, or conducted to a country, or be otherwise handed over or returned to the authorities of a country where there is, inter alia, a serious risk that he or she would be subjected to the death penalty, torture, persecution, or other inhuman or degrading treatment or punishment, or where his or her life or freedom would be threatened on account of his or her race, religion, nationality, sexual orientation, membership of a particular social group or political opinion, or from which there is a risk of expulsion, removal, extradition or return to another country in contravention of the principle of non-refoulement. 3. In the performance of its tasks, the European Border and Coast Guard shall take into account the special needs of children, unaccompanied minors, persons with disabilities, victims of trafficking in human beings, persons in need of medical assistance, persons in need of international protection, persons in distress at sea and other persons in a particularly vulnerable situation, and shall address those needs within its mandate. The European Border and Coast Guard shall in all its activities pay particular attention to children's rights and ensure that the best interests of the child are respected. 4. In the performance of its tasks, in its relations with Member States and in its cooperation with third countries, the Agency shall take into account the reports of the consultative forum referred to in Article 108 and the reports of the fundamental rights officer. Article 81 Code of conduct 1. The Agency shall, in cooperation with the consultative forum, draw up and further develop a code of conduct which shall apply to all border control operations coordinated by the Agency and all persons participating in the activities of the Agency. The code of conduct shall lay down procedures intended to guarantee the principles of the rule of law and respect for fundamental rights with particular focus on vulnerable persons, including children, unaccompanied minors and other persons in a vulnerable situation, as well as on persons seeking international protection. 2. The Agency shall, in cooperation with the consultative forum, draw up and further develop a code of conduct for return operations and return interventions, which shall apply during all return operations and return interventions coordinated or organised by the Agency. That code of conduct shall describe common standardised procedures to simplify the organisation of return operations and return interventions, and shall assure return in a humane manner and with full respect for fundamental rights, in particular the principles of human dignity, the prohibition of torture and of inhuman or degrading treatment or punishment, the right to liberty and security and the right to the protection of personal data and non-discrimination. 3. The code of conduct for return shall in particular pay attention to the obligation of Member States to provide for an effective forced-return monitoring system as set out in Article 8(6) of Directive 2008/115/EC and to the fundamental rights strategy. Article 82 Tasks and powers of the members of the teams 1. Members of the teams shall have the capacity to perform tasks and exercise powers for border control and return as well as those which are necessary for the realisation of the objectives of Regulations (EU) No 656/2014 and (EU) 2016/399 and Directive 2008/115/EC. 2. The performance of tasks and the exercise of powers by members of the teams, in particular those requiring executive powers, shall be subject to the authorisation of the host Member State on its territory as well as to applicable Union, national or international law, in particular Regulation (EU) No 656/2014, as described in the operational plans referred to in Article 38. 3. While performing their tasks and exercising their powers, members of the teams shall fully ensure respect for fundamental rights and shall comply with Union and international law and the national law of the host Member State. 4. Without prejudice to Article 95(1) as regards statutory staff, members of the teams shall only perform tasks and exercise powers under instructions from and, as a general rule, in the presence of border guards or staff involved in return-related tasks of the host Member State. The host Member State may authorise members of the teams to act on its behalf. 5. The host Member State may report incidents related to non-compliance with the operational plan by members of the teams, including in relation to fundamental rights, to the Agency via the coordinating officer for possible follow-up, which may include disciplinary measures. 6. Statutory staff who are members of the teams shall wear the uniform of the standing corps while performing their tasks and exercising their powers. Members of the teams who are seconded from Member States for a long term or who are deployed for a short term shall wear their own uniform while performing their tasks and exercising their powers. By way of derogation from the first subparagraph of this paragraph, the decision of the management board referred to in point (a) of Article 54(4) shall indicate the profiles to which the obligation to wear a uniform does not apply due to the specific nature of the operational activity. All members of the teams shall wear visible personal identification and a blue armband with the insignias of the Union and of the Agency on their uniforms, identifying them as participating in a joint operation, migration management support team deployment, pilot project, rapid border intervention, return operation or return intervention. For the purposes of identification vis-à-vis the national authorities of the host Member State, members of the teams shall at all times carry an accreditation document, which they shall present upon request. The design and specifications for the uniforms of the statutory staff shall be established by a decision of the management board, on the basis of a proposal from the executive director made after receiving the opinion of the Commission. 7. For staff who are seconded to the Agency or deployed from a Member State for a short term, the ability to carry and use service weapons, ammunition and equipment shall be subject to the home Member State's national law. The ability to carry and use service weapons, ammunition and equipment by the statutory staff who are deployed as members of the teams shall be subject to the framework and detailed rules laid down in this Article and Annex V. For the purpose of implementing this paragraph, the executive director may authorise statutory staff to carry and use weapons in accordance with the rules adopted by the management board, in line with point (b) of Article 55(5). 8. Members of the teams, including statutory staff, shall be authorised for the relevant profiles by the host Member State to perform tasks during a deployment that require the use of force, including the carrying and use of service weapons, ammunition and equipment, and shall be subject to the consent of either the home Member State or, for statutory staff, the Agency. The use of force, including the carrying and use of service weapons, ammunition and equipment, shall be exercised in accordance with the national law of the host Member State and in the presence of border guards of the host Member State. The host Member State may, with the consent of the home Member State or the Agency, where appropriate, authorise members of the teams to use force on its territory in the absence of border guards of the host Member State. The host Member State may prohibit the carrying of certain service weapons, ammunition and equipment, provided that its own law applies the same prohibition to its own border guards or staff when involved in return-related tasks. The host Member State, in advance of the deployment of the members of the teams, shall inform the Agency of the permissible service weapons, ammunition and equipment and of the conditions for their use. The Agency shall make this information available to Member States. 9. Service weapons, ammunition and equipment may be used in legitimate self-defence and in legitimate defence of members of the teams or of other persons in accordance with the national law of the host Member State in line with relevant principles of international human rights law and the Charter. 10. For the purpose of this Regulation, the host Member State shall authorise members of the teams to consult Union databases, the consultation of which is necessary for fulfilling operational aims specified in the operational plan on border checks, border surveillance and return, through their national interfaces or another form of access provided in the Union legal acts establishing such databases, as applicable. The host Member State may also authorise members of the teams to consult its national databases where necessary for the same purpose. Member States shall ensure that they provide such database access in an efficient and effective manner. Members of the teams shall consult only those data which are strictly necessary for performing their tasks and exercising their powers. The host Member State shall, in advance of the deployment of the members of the teams, inform the Agency of the national and Union databases which may be consulted. The Agency shall make this information available to all Member States participating in the deployment. That consultation shall be carried out in accordance with Union data protection law and the national data protection law of the host Member State. 11. Decisions to refuse entry in accordance with Article 14 of Regulation (EU) 2016/399 and decisions refusing visas at the border in accordance with Article 35 of Regulation (EC) No 810/2009 shall be taken only by border guards of the host Member State or by members of the teams if they are authorised by the host Member State to act on its behalf. Article 83 Accreditation document 1. The Agency shall, in cooperation with the host Member State, issue a document in the official language of the host Member State and another official language of the institutions of the Union to the members of the teams for the purpose of identifying them and as proof of the holder's rights to perform tasks and exercise powers as referred to in Article 82. That document shall include the following features of each member of the teams: (a) name and nationality; (b) rank or job title; (c) a recent digitised photograph; and (d) tasks authorised to be performed during the deployment. 2. The document shall be returned to the Agency at the end of each joint operation, migration management support team deployment, pilot project, rapid border intervention, return operation or return intervention. Article 84 Civil liability of the members of the team 1. Without prejudice to Article 95, where members of the teams are operating in a host Member State, that Member State shall be liable in accordance with its national law for any damage caused by them during their operations. 2. Where such damage is caused by the gross negligence or wilful misconduct of the members of the teams seconded or deployed by the Member States, the host Member State may request the home Member State to reimburse it for any sums that the host Member State has paid to the injured parties or persons entitled to receive such sums on behalf of the injured parties. Where such damage is caused by gross negligence or wilful misconduct by the statutory staff, the host Member State may request the Agency to reimburse it for any sums that the host Member State has paid to the injured parties or persons entitled to receive such sums on behalf of the injured parties. This shall be without prejudice to any action before the Court of Justice of the European Union (the ‘Court of Justice’) against the Agency in accordance with Article 98. 3. Without prejudice to the exercise of its rights vis-à-vis third parties, each Member State shall waive all its claims against the host Member State or any other Member State for any damage it has sustained, except in cases of gross negligence or wilful misconduct. 4. Any dispute between Member States, or between a Member State and the Agency, relating to the application of paragraphs 2 and 3 of this Article which cannot be resolved by negotiations between them shall be submitted by them to the Court of Justice. 5. Without prejudice to the exercise of its rights vis-à-vis third parties, the Agency shall bear the costs of damage to its equipment during deployment, except in cases of gross negligence or wilful misconduct. Article 85 Criminal liability of the members of the teams Without prejudice to Article 95, during a joint operation, pilot project, migration management support team deployment, rapid border intervention, return operation or return intervention, members of the teams in the territory of the host Member State, including statutory staff, shall be treated in the same way as officials of the host Member State with regard to any criminal offences that might be committed against them or by them. SECTION 2 Processing of personal data by the European Border and Coast Guard Article 86 General rules on processing of personal data by the Agency 1. The Agency shall apply Regulation (EU) 2018/1725 when processing personal data. 2. The management board shall adopt internal rules on the application of Regulation (EU) 2018/1725 by the Agency, including rules concerning the data protection officer of the Agency. The Agency may, in accordance with Article 25 of Regulation (EU) 2018/1725, adopt internal rules restricting the application of Articles 14 to 22, 35 and 36 of that Regulation. In particular, the Agency may, for the performance of its tasks in the area of return, provide for internal rules restricting the application of those provisions on a case-by-case basis as long as the application of those provisions would risk jeopardising return procedures. Such restrictions shall respect the essence of the fundamental rights and freedoms, shall be necessary and proportionate to the objectives pursued and shall contain specific provisions, where relevant, as referred to in Article 25(2) of Regulation (EU) 2018/1725. 3. The Agency may transfer the personal data referred to in Articles 49, 88 and 89 to a third country or to an international organisation in accordance with Chapter V of Regulation (EU) 2018/1725 insofar as such transfer is necessary for the performance of the Agency's tasks. The Agency shall ensure that personal data that are transferred to a third country or to an international organisation are only processed for the purpose for which they were provided. The Agency shall indicate, at the moment of transferring personal data to a third country or to an international organisation, any restrictions on access to or use of those data, in general or specific terms, including as regards transfer, erasure or destruction. Where the need for such restrictions becomes apparent after the transfer of personal data, the Agency shall inform the third country or the international organisation accordingly. The Agency shall ensure that the third country or international organisation concerned complies with such restrictions. 4. Transfers of personal data to third countries shall not prejudice the rights of applicants for international protection and of beneficiaries of international protection, in particular as regards non-refoulement and the prohibition against disclosing or obtaining information set out in Article 30 of Directive 2013/32/EU of the European Parliament and of the Council (43). 5. Member States and the Agency, as appropriate, shall ensure that information that is transferred or disclosed to third countries pursuant to this Regulation is not transmitted onward to other third countries or third parties. Provisions to that effect shall be included in any agreement or arrangement concluded with a third country providing for the exchange of information. Article 87 Purposes of processing of personal data 1. The Agency may process personal data only for the following purposes: (a) performing its tasks of organising and coordinating joint operations, pilot projects, rapid border interventions and in the framework of the migration management support teams as referred to in Articles 37 to 40; (b) performing its tasks of supporting Member States and third countries in pre-return and return activities, operating return management systems, as well as coordinating or organising return operations and providing technical and operational assistance to Member States and third countries in accordance with Article 48; (c) facilitating the exchange of information with Member States, the Commission, the EEAS and the following Union bodies, offices and agencies and international organisations: EASO, the European Union Satellite Centre, EFCA, EMSA, EASA and the Network Manager of the EATMN, in accordance with Article 88; (d) facilitating the exchange of information with the law enforcement authorities of the Member States, Europol or Eurojust in accordance with Article 90; (e) risk analysis by the Agency in accordance with Article 29; (f) performing its tasks in the framework of EUROSUR in accordance with Article 89; (g) operating the FADO system in accordance with Article 79; (h) administrative tasks. 2. Member States and their law enforcement authorities, the Commission, the EEAS, and those Union bodies, offices and agencies and international organisations referred to in points (c) and (d) of paragraph 1, that provide personal data to the Agency shall determine the purpose or the purposes for which those data are to be processed as referred to in paragraph 1. The Agency may decide to process such personal data for a different purpose which also falls under paragraph 1 only on a case-by-case basis after having determined that such processing is compatible with the initial purpose for which the data were collected and if authorised by the provider of the personal data. The Agency shall keep written records of case-by-case compatibility assessments. 3. The Agency, the Member States and their law enforcement authorities, the Commission, the EEAS, and those Union bodies, offices and agencies and international organisations referred to in points (c) and (d) of paragraph 1, may indicate, at the moment of transmitting personal data, any restrictions on access to those data or use of such data, in general or specific terms, including as regards the transfer, erasure or destruction of such data. Where the need for such restrictions becomes apparent after the transfer of personal data, they shall inform the recipients accordingly. The recipients shall comply with such restrictions. Article 88 Processing of personal data collected during joint operations, return operations, return interventions, pilot projects, rapid border interventions, and migration management support team deployments 1. Before each joint operation, return operation, return intervention, pilot project, rapid border intervention or migration management support team deployment, the Agency and the host Member State shall determine in a transparent manner the responsibilities for compliance with the data protection obligations. When the purpose and the means of processing are jointly determined by the Agency and the host Member State, they shall be joint controllers by means of concluding an arrangement between them. For the purposes referred to in points (a), (b), (c), (e) and (f) of Article 87(1), the Agency shall only process the following categories of personal data collected by the Member States, by members of the teams, by its staff or by EASO that have been transmitted to it in the context of joint operations, return operations, return interventions, pilot projects, rapid border interventions, and migration management support team deployments: (a) the personal data of persons who cross the external borders without authorisation; (b) personal data that are necessary to confirm the identity and nationality of third-country nationals within the framework of the return activities, including passenger lists; (c) licence plate numbers, vehicle identification numbers, telephone numbers or ship and aircraft identification numbers which are linked to the persons referred to in point (a), and which are necessary for analysing routes and methods used for illegal immigration. 2. The personal data referred to in paragraph 1 may be processed by the Agency in the following cases: (a) where the transmission of those data to the authorities of the relevant Member States which are responsible for border control, migration, asylum or return, or to relevant Union bodies, offices and agencies, is necessary for those authorities or Union bodies, offices and agencies to fulfil their tasks in accordance with Union and national law; (b) where transmission of those data to the authorities of relevant Member States, relevant Union bodies, offices and agencies, third countries of return or international organisations is necessary for the purpose of identifying third-country nationals, acquiring travel documents or enabling or supporting return; (c) where necessary for the preparation of risk analyses. Article 89 Processing of personal data in the framework of EUROSUR 1. Where the national situational picture requires the processing of personal data, those data shall be processed in accordance with Regulation (EU) 2016/679 and, where applicable, Directive (EU) 2016/680. Each Member State shall designate the authority which is to be considered as controller within the meaning of point 7 of Article 4 of Regulation (EU) 2016/679 or point (8) of Article 3 of Directive (EU) 2016/680, as applicable, and which shall have central responsibility for the processing of personal data by that Member State. Each Member State shall notify the details of that authority to the Commission. 2. Ship and aircraft identification numbers shall be the only personal data that are permitted to be accessed in the European situational and specific situational pictures and the EUROSUR fusion services. 3. Where the processing of information in EUROSUR exceptionally requires the processing of personal data other than ship and aircraft identification numbers, any such processing shall be strictly limited to what is necessary for the purposes of EUROSUR in accordance with Article 18. 4. Any exchange of personal data with third countries in the framework of EUROSUR shall be strictly limited to what is absolutely necessary for the purposes of this Regulation. It shall be carried out in accordance with Chapter V of Regulation (EU) 2018/1725 by the Agency, and in accordance with Chapter V of Regulation (EU) 2016/679, with Chapter V of Directive (EU) 2016/680, as applicable, and with the relevant national provisions on data protection transposing that Directive, by the Member States. 5. Any exchange of information under Articles 72(2), 73(3) and 74(3) which provides a third country with data that could be used to identify persons or groups of persons whose request for access to international protection is under examination or who are under a serious risk of being subjected to torture, inhuman and degrading treatment or punishment, or any other violation of fundamental rights, shall be prohibited. 6. Member States and the Agency shall keep records of processing activities in accordance with, Article 30 of Regulation (EU) 2016/679, Article 24 of Directive (EU) 2016/680, and Article 31 of Regulation (EU) 2018/1725, as applicable. Article 90 Processing of operational personal data 1. Where the Agency, in the performance of its tasks under point (q) of Article 10(1) of this Regulation, processes personal data which it has collected while monitoring migratory flows, carrying out risk analyses or in the course of operations for the purpose of identifying suspects of cross-border crime, it shall process such personal data in accordance with Chapter IX of Regulation (EU) 2018/1725. Personal data processed for that purpose, including licence plate numbers, vehicle identification numbers, telephone numbers and ship or aircraft identification numbers which are linked to such persons, shall relate to natural persons whom the competent authorities of the Member States, Europol, Eurojust, or the Agency have reasonable grounds to suspect are involved in cross-border crime. Such personal data may include personal data of victims or witnesses where those personal data supplement the personal data of suspects processed by the Agency in accordance with this Article. 2. The Agency shall only exchange personal data as referred to in paragraph 1 of this Article with: (a) Europol or Eurojust where they are strictly necessary for the performance of their respective mandates and in accordance with Article 68; (b) the competent law enforcement authorities of the Member States where they are strictly necessary for those authorities for the purposes of preventing, detecting, investigating or prosecuting serious cross-border crime. Article 91 Data retention 1. The Agency shall delete personal data as soon as they have been transmitted to the competent authorities of Member States, other Union bodies, offices and agencies, in particular EASO, or transferred to third countries or international organisations or used for the preparation of risk analyses. The retention period shall, in any event, not exceed 90 days after the date of the collection of those data. Data shall be anonymised in the results of risk analyses. 2. Personal data processed for the purpose of performing return-related tasks shall be deleted as soon as the purpose for which they have been collected has been achieved, and shall be deleted no later than 30 days after the end of those tasks. 3. Operational personal data processed for the purposes of Article 90 shall be deleted as soon as the purpose for which they have been collected has been achieved by the Agency. The Agency shall continuously review the necessity of storing such data, in particular the personal data of victims and witnesses. In any case, the Agency shall review the necessity of storing such data no later than three months after the start of initial processing of such data, and every six months thereafter. The Agency shall decide on the continued storage of personal data, in particular the personal data of victims and witnesses, until the following review, only if such storage is still necessary for the performance of the Agency's tasks under Article 90. 4. This Article does not apply to personal data collected in the context of the FADO system. Article 92 Security rules on the protection of classified information and sensitive non-classified information 1. The Agency shall adopt its own security rules that shall be based on the principles and rules laid down in the Commission's security rules for protecting European Union classified information (EUCI) and sensitive non-classified information including, inter alia, provisions for the exchange of such information with third countries, and processing and storage of such information as set out in Commission Decisions (EU, Euratom) 2015/443 (44) and (EU, Euratom) 2015/444 (45). Any administrative arrangement on the exchange of classified information with the relevant authorities of a third country or, in the absence of such arrangement, any exceptional ad hoc release of EUCI to those authorities, shall be subject to the Commission's prior approval. 2. The management board shall adopt the Agency's security rules following approval by the Commission. When assessing the proposed security rules, the Commission shall ensure that they are compatible with Decisions (EU, Euratom) 2015/443 and (EU, Euratom) 2015/444. 3. Classification shall not preclude information being made available to the European Parliament. The transmission and handling of information and documents transmitted to the European Parliament in accordance with this Regulation shall comply with the rules concerning the forwarding and handling of classified information which are applicable between the European Parliament and the Commission. SECTION 3 General framework and organisation of the Agency Article 93 Legal status and location 1. The Agency shall be a body of the Union. It shall have legal personality. 2. In each of the Member States, the Agency shall enjoy the most extensive legal capacity accorded to legal persons under their laws. It may, in particular, acquire or dispose of movable and immovable property and may be party to legal proceedings. 3. The Agency shall be independent in implementing its technical and operational mandate. 4. The Agency shall be represented by its executive director. 5. The seat of the Agency shall be Warsaw, Poland. Article 94 Headquarters agreement 1. The necessary arrangements concerning the accommodation to be provided for the Agency in the Member State in which the Agency has its seat and the facilities to be made available by that Member State, as well as the specific rules applicable to the executive director, the deputy executive directors, the members of the management board, Agency staff and members of their families in that Member State shall be laid down in a headquarters agreement between the Agency and the Member State in which the Agency has its seat. 2. The headquarters agreement shall be concluded after obtaining the approval of the management board. 3. The Member State in which the Agency has its seat shall provide the best possible conditions to ensure the proper functioning of the Agency, including multilingual, European-oriented schooling and appropriate transport connections. Article 95 Staff 1. The Staff Regulations, the Conditions of Employment and the rules adopted in agreement between the institutions of the Union for giving effect to those Staff Regulations and those Conditions of Employment shall apply to statutory staff. 2. The place of employment shall in principle be the Member State where the Agency's seat is located. 3. Statutory staff who are subject to the Conditions of Employment shall in principle be engaged initially for a fixed period of five years. Their contracts may in principle be renewed only once, for a fixed period of a maximum of five years. Any further renewal shall be for an indefinite period. 4. For the purpose of implementing Articles 31 and 44, only statutory staff who are subject to the Staff Regulations or to Title II of the Conditions of Employment may be appointed as liaison officers or coordinating officers. For the purpose of implementing Article 55, only statutory staff who are subject to the Staff Regulations or of the Conditions of Employment may be deployed as members of the teams. 5. The management board shall adopt implementing rules for giving effect to the Staff Regulations and Conditions of Employment in agreement with the Commission pursuant to Article 110(2) of the Staff Regulations. 6. Subject to prior approval by the Commission, the management board shall adopt rules related to staff from Member States to be seconded to the Agency in accordance with Article 56 and update them as necessary. Those rules shall include, in particular, the financial arrangements related to those secondments, including insurance, and training. Those rules shall take into account the fact that the staff are seconded to be deployed as members of the teams and are to have the tasks and powers provided for in Article 82. Such rules shall include provisions on the conditions of deployment. Where relevant, the management board shall aim to ensure consistency with the rules applicable to reimbursement of the mission expenses of the statutory staff. Article 96 Privileges and immunities Protocol No 7 on the Privileges and Immunities of the European Union annexed to the Treaty on European Union (TEU) and to the TFEU shall apply to the Agency and its statutory staff. Article 97 Liability 1. Without prejudice to Articles 84 and 85, the Agency shall be liable for any activities it has undertaken in accordance with this Regulation. 2. The contractual liability of the Agency shall be governed by the law applicable to the contract in question. 3. The Court of Justice shall have jurisdiction to give judgment pursuant to any arbitration clause contained in a contract concluded by the Agency. 4. In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its departments or by its staff in the performance of their duties, including those related to the use of executive powers. 5. The Court of Justice shall have jurisdiction in disputes relating to compensation for the damage referred to in paragraph 4. 6. The personal liability of statutory staff towards the Agency shall be governed by the provisions laid down in the Staff Regulations and Conditions of Employment applicable to them. Article 98 Actions before the Court of Justice 1. Proceedings may be brought before the Court of Justice for the annulment of acts of the Agency that are intended to produce legal effects vis-à-vis third parties, in accordance with Article 263 TFEU, and for failure to act, in accordance with Article 265 TFEU, for non-contractual liability for damages caused by the Agency and, pursuant to an arbitration clause, contractual liability for damages caused by acts of the Agency, in accordance with Article 340 TFEU. 2. The Agency shall take the necessary measures to comply with judgments of the Court of Justice. Article 99 Administrative and management structure of the Agency The administrative and management structure of the Agency shall include: (a) a management board; (b) an executive director; (c) deputy executive directors; and (d) a fundamental rights officer; A consultative forum shall assist the Agency as an advisory body. Article 100 Functions of the management board 1. The management board shall be responsible for taking the strategic decisions of the Agency in accordance with this Regulation. 2. The management board shall: (a) appoint the executive director on the basis of a proposal from the Commission in accordance with Article 107; (b) appoint the deputy executive directors on the basis of a proposal from the Commission in accordance with Article 107; (c) adopt decisions on establishing antenna offices or prolonging the duration of their operation in accordance with Article 60(5) by a majority of two thirds of the members with a right to vote; (d) adopt decisions on conducting the vulnerability assessment in accordance with Article 32(1) and (10), with the decisions setting out measures adopted under Article 32(10) being passed by a majority of two thirds of the members with a right to vote; (e) adopt decisions on the lists of mandatory information and data to be exchanged with the Agency by the national authorities responsible for border management, including coast guards to the extent that they carry out border control tasks, as well as the national authorities responsible for return, to enable the Agency to perform its tasks, without prejudice to obligations established by this Regulation, in particular by Articles 49 and 86 to 89; (f) adopt decisions on the establishment of a common integrated risk analysis model in accordance with Article 29(1); (g) adopt decisions on the nature and terms of the deployment of liaison officers in Member States in accordance with Article 31(2); (h) adopt a technical and operational strategy for European integrated border management in accordance with Article 8(5); (i) adopt decisions on the profiles and the numbers of operational staff for the management of borders and migration within the standing corps, in accordance with Article 54(4); (j) adopt the Agency's annual activity report for the previous year and transmit it, by 1 July of each year at the latest, to the European Parliament, to the Council, to the Commission and to the Court of Auditors; (k) before 30 November of each year, and after duly taking into account the opinion of the Commission, adopt, by a majority of two thirds of the members with a right to vote, a single programming document containing, inter alia, the Agency's multiannual programming and its work programme for the following year and forward it to the European Parliament, to the Council and to the Commission; (l) establish procedures for the executive director to take decisions relating to the technical and operational tasks of the Agency; (m) adopt, by a majority of two thirds of the members with a right to vote, the annual budget of the Agency and exercise other functions in respect of the Agency's budget pursuant to Section 4 of this Chapter; (n) exercise disciplinary authority over the executive director and, in consultation with the executive director, over the deputy executive directors; (o) establish its rules of procedure; (p) establish the organisational structure of the Agency and adopt the Agency's staff policy; (q) adopt an anti-fraud strategy that is proportionate to the risk of fraud, taking into account the costs and benefits of the measures to be implemented; (r) adopt internal rules for the prevention and management of conflicts of interest in respect of its members; (s) exercise, in accordance with paragraph 8, with respect to statutory staff, the powers conferred by the Staff Regulations on the Appointing Authority and by the Conditions of Employment on the Authority Empowered to Conclude a Contract of Employment (the ‘appointing-authority powers’); (t) adopt implementing rules for giving effect to the Staff Regulations and the Conditions of Employment in accordance with Article 110(2) of the Staff Regulations; (u) ensure adequate follow-up to findings and recommendations stemming from the internal or external audit reports and evaluations, as well as from investigations of the European Anti-Fraud Office (OLAF); (v) adopt and regularly update the communication and dissemination plans referred to in the second subparagraph of Article 10(2); (w) appoint an accounting officer, subject to the Staff Regulations and the Conditions of Employment, who shall be completely independent in the performance of his or her duties; (x) decide on a common vulnerability assessment methodology, including the objective criteria against which the Agency shall carry out the vulnerability assessment, the frequency of such assessments and how consecutive vulnerability assessments are to be carried out; (y) decide on enhanced assessment and monitoring of a Member State as referred to in Article 32(2); (z) appoint the fundamental rights officer and a deputy fundamental rights officer in accordance with Article 109; (aa) establish special rules in order to guarantee the independence of the fundamental rights officer in the performance of his or her duties; (ab) approve the working arrangements with third countries; (ac) subject to the prior approval of the Commission, adopt the security rules of the Agency on protecting EUCI and sensitive non-classified information as referred to in Article 92; (ad) appoint a security officer, subject to the Staff Regulations and the Conditions of Employment, who shall be responsible for the security within the Agency, including for the protection of classified information and sensitive non-classified information; (ae) decide on any other matter where provided for in this Regulation. The annual activity report referred to in point (j) shall be made public. 3. Proposals for decisions of the management board, as referred to in paragraph 2, on specific activities of the Agency to be carried out at, or in the immediate vicinity of, the external borders of any particular Member State or on working arrangements with third countries as referred to in Article 73(4) shall require a vote in favour of their adoption by the member of the management board representing that particular Member State or the Member State neighbouring that third country, respectively. 4. The management board may advise the executive director on any matter related to the development of operational management of the external borders and training, including activities related to research. 5. Should Ireland or the United Kingdom request to participate in specific activities, the management board shall decide thereon. The management board shall take its decisions on a case-by-case basis. In its decisions, the management board shall consider whether the participation of Ireland or the United Kingdom contributes to the achievement of the activity in question. The decisions shall set out the financial contribution of Ireland or the United Kingdom to the activity for which the request for participation has been made. 6. The management board shall forward annually to the European Parliament and to the Council (‘the budgetary authority’) any information relevant to the outcome of the evaluation procedures conducted by the Agency. 7. The management board may establish an executive board composed of up to four representatives of the management board, including its chairperson, and a representative of the Commission, to assist it and the executive director with regard to the preparation of the decisions, programmes and activities to be adopted by the management board and to take certain provisional, urgent decisions on behalf of the management board when necessary. The executive board shall not take decisions that must be passed by a majority of two thirds of the management board. The management board may delegate certain clearly defined tasks to the executive board, in particular where this improves the efficiency of the Agency. It may not delegate to the executive board tasks related to decisions that must be passed by a majority of two thirds of the management board. 8. The management board shall adopt, in accordance with Article 110 of the Staff Regulations, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment, delegating relevant appointing-authority powers to the executive director and setting out the conditions under which this delegation of powers can be suspended. The executive director shall be authorised to sub-delegate those powers. Where exceptional circumstances so require, the management board may by way of a decision temporarily suspend the delegation of the appointing-authority powers to the executive director and those sub-delegated by the latter. It may then exercise them itself or delegate them to one of its members or to a statutory staff member other than the executive director. Article 101 Composition of the management board 1. Without prejudice to paragraph 3, the management board shall be composed of one representative of each Member State and two representatives of the Commission, each with a right to vote. To this effect, each Member State shall appoint a member of the management board as well as an alternate who will represent the member in his or her absence. The Commission shall appoint two members and two alternates. The duration of the terms of office shall be four years. The terms of office shall be extendable. 2. The management board members shall be appointed on the basis of the degree of their relevant high-level experience, their expertise in the field of operational cooperation on border management and return, and their relevant managerial, administrative and budgetary skills. Member States and the Commission shall aim to achieve a gender-balanced representation on the management board. 3. Countries associated with the implementation, application and development of the Schengen acquis shall participate in the Agency. They shall each have one representative and one alternate on the management board. The arrangements developed under the relevant provisions of their association agreements that specify the nature and extent of, and the detailed rules for, the participation by those countries in the work of the Agency, including provisions on financial contributions and staff, shall apply. Article 102 Multiannual programming and annual work programmes 1. The management board shall, by 30 November of each year, adopt a single programming document containing, inter alia, the Agency's multiannual programming and annual programming for the following year, on the basis of a draft put forward by the executive director and endorsed by the management board. The single programming document shall be adopted taking into account a positive opinion of the Commission and, as regards the multiannual programming, after having consulted the European Parliament and the Council. If the management board decides not to take into account elements of the opinion of the Commission, it shall provide a thorough justification. The obligation to provide a thorough justification shall also apply to the elements raised by the European Parliament and the Council during the consultation. The management board shall forward the document to the European Parliament, to the Council and to the Commission without delay. 2. The document referred to in paragraph 1 shall become definitive after the final adoption of the general budget. It shall be adjusted accordingly where necessary. 3. In line with the multiannual strategic policy cycle for European integrated border management, the multiannual programming shall set out overall strategic programming for the medium and long term, which shall include objectives, expected results, performance indicators and resource planning, including the multiannual budget, staff and the development of the Agency's own capabilities, including indicative multiannual planning of the profiles of staff for the standing corps. The multiannual programming shall set out the strategic areas of intervention and what needs to be done to achieve the objectives. It shall include strategic actions for the implementation of the fundamental rights strategy referred to in Article 80(1) and a strategy for relations with third countries and international organisations as well as the actions linked to that strategy. 4. The multiannual programming shall be implemented by means of annual work programmes and shall, where appropriate, be updated following the outcome of an evaluation conducted pursuant to Article 121. The conclusion of those evaluations shall also be reflected, where appropriate, in the annual work programme for the following year. 5. The annual work programme shall contain a description of the activities to be financed, comprising detailed objectives and expected results, including performance indicators. It shall also contain an indication of the financial and human resources allocated to each activity, in accordance with the principles of activity-based budgeting and management. The annual work programme shall be consistent with the multiannual programming. It shall clearly indicate tasks that have been added, changed or deleted compared with the previous financial year. 6. The annual work programme shall be adopted in accordance with the Union legislative programme in relevant areas of the management of the external borders and return. 7. Where, after adoption of an annual work programme, a new task is assigned to the Agency, the management board shall amend the annual work programme. 8. Any substantial amendment to the annual work programme, especially a modification resulting in a reallocation of the budgetary resources above 2 % of the annual budget, shall be adopted by the same procedure as that applicable to adoption of the initial annual work programme. The management board may delegate to the executive director the power to make non-substantial amendments to the annual work programme. Article 103 Chair of the management board 1. The management board shall elect a chairperson and a deputy chairperson from among its members with a right to vote. The chairperson and the deputy chairperson shall be elected by a majority of two thirds of the members of the management board with a right to vote. The deputy chairperson shall ex officio replace the chairperson in the event of his or her being prevented from attending to his or her duties. 2. The terms of office of the chairperson and deputy chairperson shall expire when their respective membership of the management board ceases. Subject to this provision, the terms of office of the chairperson or deputy chairperson shall be four years. Those terms of office shall be extendable once. Article 104 Meetings of the management board 1. Meetings of the management board shall be convened by its chairperson. 2. The executive director shall take part in the deliberations without the right to vote. 3. The management board shall hold at least two ordinary meetings a year. In addition, it shall meet at the initiative of the chairperson, at the request of the Commission, or at the request of at least one third of the members of the management board. Where necessary, the management board may hold joint meetings with the management boards of EASO and Europol. 4. Ireland shall be invited to attend the meetings of the management board. 5. The United Kingdom shall be invited to attend meetings of the management board that take place before the day on which the Treaties cease to apply to the United Kingdom pursuant to Article 50(3) TEU. 6. Representatives of EASO and Europol shall be invited to attend the meetings of the management board. A representative of FRA shall be invited to attend meetings of the management board where points relevant to the protection of fundamental rights are on the agenda. 7. The chairperson of the management board may also invite an expert of the European Parliament to attend the meetings of the management board. The management board may also invite representatives of other relevant Union institutions, bodies, offices and agencies. The management board may invite, in accordance with its rules of procedure, any other person whose opinion may be of interest to attend its meetings as an observer. 8. The members of the management board may, subject to the provisions of its rules of procedure, be assisted by advisers or experts. 9. The secretariat for the management board shall be provided by the Agency. Article 105 Voting 1. Without prejudice to points (c), (d), (k) and (m) of Article 100(2), Article 103(1), and Article 107(2) and (4), the management board shall take its decisions by an absolute majority of its members with a right to vote. 2. Each member shall have one vote. In the absence of a member, his or her alternate shall be entitled to exercise his or her right to vote. The executive director shall not vote. 3. The rules of procedure shall set out the voting arrangements in greater detail. Those rules shall include the conditions for a member to act on behalf of another member as well as any quorum requirements. 4. Representatives of countries associated with the implementation, application and development of the Schengen acquis shall have limited voting rights corresponding to their respective arrangements. In order to allow the associated countries to exercise their right to vote, the Agency shall detail the agenda identifying the points for which a limited voting right has been granted. Article 106 Functions and powers of the executive director 1. The Agency shall be managed by its executive director, who shall be completely independent in the performance of his or her duties. Without prejudice to the respective competencies of the Union institutions and the management board, the executive director shall neither seek nor take instructions from any government or from any other body. 2. The European Parliament or the Council may invite the executive director to report on the carrying out of his or her tasks. This includes reporting on the activities of the Agency, the implementation and monitoring of the fundamental rights strategy, the annual activity report of the Agency for the previous year, the work programme for the following year and the Agency's multiannual programming and any other matter related to the activities of the Agency. The executive director shall also make a statement before the European Parliament, if requested, and shall answer in writing any question put forward by a Member of the European Parliament within 15 calendar days from receipt of such question. The executive director shall report regularly to the appropriate bodies and committees of the European Parliament. 3. Except where specific deadlines are provided for in this Regulation, the executive director shall ensure that reports are transmitted to the European Parliament, to the Council and to the Commission as soon as possible, and in any event within six months of the end of the reporting period, unless the executive director duly justifies a delay in writing. 4. The executive director shall be responsible for the preparation and implementation of the strategic decisions taken by the management board and for the taking of decisions related to the operational activities of the Agency in accordance with this Regulation. The executive director shall have the following functions and powers: (a) to propose, prepare and implement the strategic decisions and programmes and activities adopted by the management board within the limits set out in this Regulation, its implementing rules and any applicable law; (b) to take all necessary steps, including the adoption of internal administrative instructions and the publication of notices, to ensure the day-to-day administration and functioning of the Agency in accordance with this Regulation; (c) to prepare each year the draft single programming document and to submit it to the management board for endorsement before that draft is sent to the European Parliament, to the Council and to the Commission by 31 January; (d) to prepare each year the annual activity report on the Agency's activities and submit it to the management board; (e) to draw up a draft statement of estimates of the revenues and expenditure of the Agency as part of the single programming document pursuant to Article 115(3), and implement the budget pursuant to Article 116(1); (f) to delegate his or her powers to other statutory staff members subject to rules to be adopted in accordance with point (o) of Article 100(2); (g) to adopt a recommendation on measures in accordance with Article 32(7), including decisions proposing that Member States initiate and carry out joint operations, rapid border interventions or other actions referred to in Article 36(2); (h) to evaluate, approve and coordinate proposals made by Member States for joint operations or rapid border interventions in accordance with Article 37(3); (i) to evaluate, approve and coordinate requests made by Member States for return operations and return interventions in accordance with Articles 50 and 53; (j) to ensure the implementation of the operational plans referred to in Article 38, Article 42 and Article 53(3); (k) to ensure the implementation of the Council decision referred to in Article 42(1); (l) to withdraw financing of activities in accordance with Article 46; (m) to assess, prior to any operational activity of the Agency, whether there are violations of fundamental rights or international protection obligations that are of a serious nature or are likely to persist in accordance with Article 46(4) and (5); (n) to evaluate the results of activities in accordance with Article 47; (o) to identify the minimum number of items of technical equipment required to meet the Agency's needs, in particular as regards carrying out joint operations, migration management support team deployments, rapid border interventions, return operations and return interventions, in accordance with Article 64(6); (p) to propose the establishment of antenna offices or the prolongation of the duration of their operation in accordance with Article 60(5); (q) to appoint the heads of the antenna offices in accordance with Article 60(4); (r) to prepare an action plan following up on the conclusions of internal or external audit reports and evaluations, as well as on investigations by OLAF, and to report on progress to the Commission twice a year and to the management board on a regular basis; (s) to protect the financial interests of the Union by applying preventive measures against fraud, corruption and any other illegal activities by means of effective checks and, if irregularities are detected, by recovering amounts that were wrongly paid and, where appropriate, imposing effective, proportionate and dissuasive administrative and financial penalties; (t) to prepare an anti-fraud strategy for the Agency and present it to the management board for approval. 5. The executive director shall be accountable for his or her activities to the management board. 6. The executive director shall be the legal representative of the Agency. Article 107 Appointment of the executive director and the deputy executive directors 1. The Commission shall propose at least three candidates for the post of executive director and for the posts of each of the deputy executive directors on the basis of a list, following the publication of the post in the Official Journal of the European Union and, as appropriate, other press or internet sites. 2. On the basis of a proposal from the Commission, as provided for in paragraph 1, the management board shall appoint the executive director on the grounds of merit and documented high-level administrative and management skills, including relevant senior professional experience in the field of management of the external borders and return. Before appointment, the candidates proposed by the Commission shall be invited to make a statement before the competent committee or committees of the European Parliament and answer questions put by its or their members. Following such statements, the European Parliament shall adopt an opinion setting out its views and may indicate a preferred candidate. The management board shall appoint the executive director taking those views into account. The management board shall take its decision by a majority of two thirds of the members with a right to vote. If the management board takes a decision to appoint a candidate other than the candidate whom the European Parliament indicated as its preferred candidate, the management board shall inform the European Parliament and the Council in writing of the manner in which the opinion of the European Parliament was taken into account. The power to dismiss the executive director shall lie with the management board, acting on a proposal from the Commission. 3. The executive director shall be assisted by three deputy executive directors. Each deputy executive director shall be assigned a specific area of responsibility. If the executive director is absent or indisposed, one of the deputy executive directors shall take his or her place. 4. On the basis of a proposal from the Commission, as provided for in paragraph 1, the management board shall appoint the deputy executive directors on the grounds of merit and appropriate administrative and management skills, including relevant professional experience in the field of management of the external borders and return. The executive director shall be involved in the selection process. The management board shall take its decision by a majority of two thirds of the members with a right to vote. The management board shall have the power to dismiss the deputy executive directors in accordance with the procedure set out in the first subparagraph. 5. The term of office of the executive director shall be five years. By the end of that period, the Commission shall undertake an assessment that takes into account an evaluation of the executive director's performance and the Agency's future tasks and challenges. 6. The management board, acting on a proposal from the Commission that takes into account the assessment referred to in paragraph 5, may extend the term of office of the executive director once for another period of up to five years. 7. The term of office of the deputy executive directors shall be five years. The management board, acting on a proposal from the Commission, may extend that term once for another period of up to five years. 8. The executive director and the deputy executive directors shall be engaged as temporary agents of the Agency under point (a) of Article 2 of the Conditions of Employment. Article 108 Consultative forum 1. A consultative forum shall be established by the Agency to assist it by providing independent advice in fundamental rights matters. The executive director and the management board, in coordination with the fundamental rights officer, may consult the consultative forum on any matter related to fundamental rights. 2. The Agency shall invite EASO, FRA, the United Nations High Commissioner for Refugees and other relevant organisations to participate in the consultative forum. On the basis of a proposal from the fundamental rights officer that was made after consulting the executive director, the management board shall decide on the composition of the consultative forum and the terms of the transmission of information to the consultative forum. The consultative forum shall, after consulting the management board and the executive director, define its working methods and set up its work programme. 3. The consultative forum shall be consulted on the further development and implementation of the fundamental rights strategy, on the functioning of the complaints mechanism, on codes of conduct and on the common core curricula. The Agency shall inform the consultative forum of the follow-up to its recommendations. 4. The consultative forum shall prepare an annual report of its activities. That report shall be made publicly available. 5. Without prejudice to the tasks of the fundamental rights officer, the consultative forum shall be provided with effective access in a timely and effective manner to all information concerning the respect for fundamental rights, including by carrying out on-the-spot visits to joint operations or rapid border interventions subject to the agreement of the host Member State or the third country, as applicable, to hotspot areas and to return operations and return interventions, including in third countries. Where the host Member State does not agree to an on-the-spot visit by the consultative forum to a joint operation or to a rapid border intervention carried out on its territory, it shall provide the Agency with duly justified reasons in writing. Article 109 Fundamental rights officer 1. A fundamental rights officer shall be appointed by the management board on the basis of a list of three candidates, after consultation with the consultative forum. The fundamental rights officer shall have the necessary qualifications, expert knowledge and professional experience in the field of fundamental rights. 2. The fundamental rights officer shall perform the following tasks: (a) contributing to the Agency's fundamental rights strategy and the corresponding action plan, including by issuing recommendations for improving them; (b) monitoring the Agency's compliance with fundamental rights, including by conducting investigations into any of its activities; (c) promoting the Agency's respect of fundamental rights; (d) advising the Agency where he or she deems it necessary or where requested on any activity of the Agency without delaying those activities; (e) providing opinions on the operational plans drawn up for the operational activities of the Agency, on pilot projects and on technical assistance projects in third countries; (f) providing opinions on working arrangements; (g) carrying out on-the-spot visits to any joint operation, rapid border intervention, pilot project, migration management support team deployment, return operation or return intervention, including in third countries; (h) providing the secretariat of the consultative forum; (i) informing the executive director about possible violations of fundamental rights during activities of the Agency; (j) selecting and managing the fundamental rights monitors; (k) performing any other tasks, where provided for by this Regulation. The secretariat referred to in point (h) of the first subparagraph shall receive instructions directly from the consultative forum. 3. For the purposes of point (j) of the first subparagraph of paragraph 2, the fundamental rights officer shall, in particular: (a) appoint the fundamental rights monitors; (b) assign fundamental rights monitors to operations and activities as provided for in Article 110(3); (c) nominate fundamental rights monitors as forced-return monitors for the pool referred to in Article 51; (d) ensure that fundamental rights monitors are adequately trained; (e) report to the executive director on possible violations of fundamental rights reported to him or her by the fundamental rights monitors as the fundamental rights officer deems necessary; The executive director shall reply to the fundamental rights officer as to how concerns regarding possible violations of fundamental rights as referred to in point (e) of the first subparagraph have been addressed. The fundamental rights officer may entrust any of the tasks provided for in points (a) to (i) and (k) of the first subparagraph of paragraph 2 to one of the fundamental rights monitors. 4. The management board shall lay down special rules applicable to the fundamental rights officer in order to guarantee that the fundamental rights officer and his or her staff are independent in the performance of their duties. The fundamental rights officer shall report directly to the management board and shall cooperate with the consultative forum. The management board shall ensure that action is taken with regard to recommendations of the fundamental rights officer. In addition, the fundamental rights officer shall publish annual reports on his or her activities and on the extent to which the activities of the Agency respect fundamental rights. Those reports shall include information on the complaints mechanism and the implementation of the fundamental rights strategy. 5. The Agency shall ensure that the fundamental rights officer is able to act autonomously and is able to be independent in the conduct of his or her duties. The fundamental rights officer shall have sufficient and adequate human and financial resources at his or her disposal necessary for the fulfilment of his or her tasks. The fundamental rights officer shall select his or her staff, and that staff shall only report to him or her. 6. The fundamental rights officer shall be assisted by a deputy fundamental rights officer. The deputy fundamental rights officer shall be appointed by the management board from a list of at least three candidates presented by the fundamental rights officer. The deputy fundamental rights officer shall have the necessary qualifications and experience in the field of fundamental rights and shall be independent in the conduct of his or her duties. If the fundamental rights officer is absent or indisposed, the deputy fundamental rights officer shall assume the fundamental rights officer's duties and responsibilities. 7. The fundamental rights officer shall have access to all information concerning respect for fundamental rights in all the activities of the Agency. Article 110 Fundamental rights monitors 1. Fundamental rights monitors, employed as statutory staff, shall constantly assess the fundamental rights compliance of operational activities, provide advice and assistance in that regard and contribute to the promotion of fundamental rights as part of European integrated border management. 2. Fundamental rights monitors shall have the following tasks: (a) monitoring compliance with fundamental rights and providing advice and assistance on fundamental rights in the preparation, conduct and evaluation of the operational activities of the Agency which the fundamental rights officer has assigned to them to monitor; (b) acting as forced-return monitors; (c) contributing to the training activities of the Agency on fundamental rights as provided for in Article 62, including by providing training on fundamental rights. For the purposes of point (a) of the first subparagraph, fundamental rights monitors shall, in particular: (a) follow the preparation of operational plans and report to the fundamental rights officer to enable him or her to fulfil his or her tasks as provided for in point(e) of Article 109(2); (b) conduct visits, including long-term visits, where operational activities take place; (c) cooperate and liaise with the coordinating officer as provided for in Article 44 and provide advice and assistance to him or her; (d) inform the coordinating officer and report to the fundamental rights officer on any concerns related to possible violation of fundamental rights within the Agency's operational activities; and (e) contribute to the evaluation of activities as referred to in Article 47. 3. Without prejudice to paragraph 4, the fundamental rights officer shall assign at least one fundamental rights monitor to each operation. The fundamental rights officer may also decide to assign fundamental rights monitors to monitor any other operational activity he or she considers relevant. Fundamental rights monitors shall have access to all areas in which the operational activity of the Agency takes place and to all its documents relevant for the implementation of that activity. 4. Fundamental rights monitors may be nominated by the fundamental rights officer as forced-return monitors for the pool referred to in Article 51. Where fundamental rights monitors act as forced-return monitors, Article 50(5) and Article 51 shall apply, mutatis mutandis. 5. The fundamental rights officer shall appoint the fundamental rights monitors and they shall be under his or her hierarchical supervision. Fundamental rights monitors shall be independent in the performance of their duties. When present in an operational area, fundamental rights monitors shall wear insignia that clearly allow for their identification as fundamental rights monitors. 6. The Agency shall ensure that by 5 December 2020 at least 40 fundamental rights monitors are recruited by the Agency. The executive director shall assess on an annual basis whether the number of fundamental rights monitors needs to be increased in consultation with the fundamental rights officer. Following that assessment, the executive director shall, where necessary, propose an increase in the number of fundamental rights monitors to the management board for the following year depending on operational needs. 7. Following their recruitment, fundamental rights monitors shall undergo enhanced fundamental rights training, taking into account previously acquired qualifications and professional experience in the relevant areas. Throughout their employment, the Agency shall ensure that fundamental rights monitors discharge their duties in accordance with the highest standards. Adequate training maps shall be designed for each fundamental rights monitor to ensure their continuous professional development to enable them to fulfil their role as fundamental rights monitors. Article 111 Complaints mechanism 1. The Agency shall, in cooperation with the fundamental rights officer, take the necessary measures to set up and further develop an independent and effective complaints mechanism in accordance with this Article to monitor and ensure respect for fundamental rights in all the activities of the Agency. 2. Any person who is directly affected by the actions or failure to act on the part of staff involved in a joint operation, pilot project, rapid border intervention, migration management support team deployment, return operation, return intervention or an operational activity of the Agency in a third country, and who considers himself or herself to have been the subject of a breach of his or her fundamental rights due to those actions or that failure to act, or any party representing such a person, may submit a complaint in writing to the Agency. 3. Only complaints that are substantiated and involve concrete fundamental rights violations shall be admissible. 4. The fundamental rights officer shall be responsible for handling complaints received by the Agency in accordance with the right to good administration. For that purpose, the fundamental rights officer shall review the admissibility of a complaint, register admissible complaints, forward all registered complaints to the executive director and forward complaints concerning members of the teams to the home Member State, including the relevant authority or body competent for fundamental rights in a Member State for further action in accordance with their mandate. The fundamental rights officer shall also register and ensure the follow-up by the Agency or that Member State. 5. In accordance with the right to good administration, if a complaint is admissible, complainants shall be informed that the complaint has been registered, that an assessment has been initiated and that a response may be expected as soon as it becomes available. If a complaint is forwarded to national authorities or bodies, the complainant shall be provided with their contact details. If a complaint is declared inadmissible, the complainant shall be informed of the reasons and, if possible, provided with further options for addressing their concerns. The Agency shall provide for an appropriate procedure in cases where a complaint is declared inadmissible or unfounded. Any decision shall be in written form and reasoned. The fundamental rights officer shall reassess the complaint if the complainant submits new evidence in situations where the complaint has been declared inadmissible or unfounded. 6. In the case of a registered complaint concerning a staff member of the Agency, the fundamental rights officer shall recommend appropriate follow-up, including disciplinary measures, to the executive director and, where appropriate, referral for the initiation of civil or criminal justice proceedings in accordance with this Regulation and national law. The executive director shall ensure the appropriate follow-up and shall report back to the fundamental rights officer within a determined timeframe and, if necessary, at regular intervals thereafter, as to the findings, the implementation of disciplinary measures, and follow-up by the Agency in response to a complaint. If a complaint is related to data protection issues, the executive director shall consult the data protection officer of the Agency before taking a decision on the complaint. The fundamental rights officer and the data protection officer shall establish, in writing, a memorandum of understanding specifying their division of tasks and cooperation as regards complaints received. 7. In the case of a registered complaint concerning a member of the teams from a host Member State or from another participating Member State, including a seconded member of the teams or seconded national expert, the home Member State shall ensure appropriate follow-up, including disciplinary measures, referral for the initiation of civil or criminal justice proceedings as necessary, and other measures in accordance with national law. The relevant Member State shall report back to the fundamental rights officer within a determined time period as to the findings and follow-up to the complaint, and, if necessary, at regular intervals thereafter. The Agency shall follow up on the matter if no report is received from the relevant Member State. Where the relevant Member State, within the determined time period, does not report back or provides only an inconclusive response, the fundamental rights officer shall inform the executive director and the management board. 8. Where a member of the teams is found to have violated fundamental rights or international protection obligations, the Agency shall request that the Member State remove that member immediately from the activity of the Agency or the standing corps. 9. The fundamental rights officer shall include information on the complaints mechanism in his or her annual report, as referred to in Article 109(4), including specific references to the Agency's and Member States' findings and the follow-up to complaints. 10. The fundamental rights officer shall, in accordance with paragraphs 1 to 9 and after consulting the consultative forum, draw up a standardised complaint form requiring detailed and specific information concerning the alleged breach of fundamental rights. The fundamental rights officer shall also draw up any further detailed rules as necessary. The fundamental rights officer shall submit that form and such further detailed rules to the executive director and to the management board. The Agency shall ensure that information about the possibility and procedure for making a complaint is readily available, including for vulnerable persons. The standardised complaint form shall be made available on the Agency's website and in hardcopy during all activities of the Agency in languages that third-country nationals understand or are reasonably believed to understand. The standardised complaint form shall be easily accessible, including on mobile devices. The Agency shall ensure that further guidance and assistance on the complaints procedure is provided to complainants. Complaints shall be considered by the fundamental rights officer even when they have not been submitted in the standardised complaint form. 11. Any personal data contained in a complaint shall be handled and processed by the Agency, including the fundamental rights officer, in accordance with Regulation (EU) 2018/1725 and by Member States in accordance with Regulation (EU) 2016/679 and Directive (EU) 2016/680. Where a complainant submits a complaint, that complainant shall be understood to consent to the processing of his or her personal data by the Agency and the fundamental rights officer within the meaning of point (d) of Article 5(1) of Regulation (EU) 2018/1725. In order to safeguard the interests of the complainants, complaints shall be dealt with confidentially by the fundamental rights officer in accordance with national and Union law unless the complainant explicitly waives his or her right to confidentiality. When complainants waive their right to confidentiality, it shall be understood that they consent to the fundamental rights officer or the Agency disclosing their identity to the competent authorities or bodies in relation to the matter under complaint, where necessary. Article 112 Interparliamentary cooperation 1. In order to address the specific nature of the European Border and Coast Guard, in that it is composed of national authorities and the Agency, and to ensure that the scrutiny functions of the European Parliament over the Agency and of the national parliaments over their respective national authorities are effectively exercised, as provided for in the Treaties and by national law respectively, the European Parliament and the national parliaments may cooperate in the framework of Article 9 of Protocol No 1 on the Role of National Parliaments in the European Union annexed to the TEU and to the TFEU. 2. When invited by the European Parliament and the national parliaments meeting within the context of paragraph 1, the executive director and the chairperson of the management board shall attend such meetings. 3. The Agency shall transmit its annual activity report to the national parliaments. Article 113 Language arrangements 1. Regulation No 1 (46) shall apply to the Agency. 2. Without prejudice to decisions taken on the basis of Article 342 TFEU, the annual activity report and the work programme shall be produced in all official languages of the Union. 3. The translation services required for the functioning of the Agency shall be provided by the Translation Centre for the Bodies of the European Union. Article 114 Transparency and communication 1. The Agency shall be subject to Regulation (EC) No 1049/2001 when handling applications for access to documents held by it. 2. The Agency shall communicate on matters falling within the scope of its tasks on its own initiative. It shall make public relevant information, including the annual activity report, the annual work programme, the code of conduct, strategic risk analyses, and comprehensive information on past and current joint operations, rapid border interventions, pilot projects, technical assistance projects with third countries, migration management support team deployments, return operations or return interventions, including in third countries, and working arrangements, and shall ensure, without prejudice to Article 92, in particular that the public and any interested party are rapidly given objective, detailed, comprehensive, reliable and easily understandable information with regard to its work. It shall do so without revealing operational information which, if made public, would jeopardise attainment of the objectives of operations. 3. The management board shall lay down the practical arrangements for the application of paragraphs 1 and 2. 4. Any natural or legal person shall be entitled to address written correspondence to the Agency in any of the official languages of the Union. He or she shall have the right to receive an answer in the same language. 5. Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may give rise to a complaint being lodged with the European Ombudsman or to an action before the Court of Justice, under the conditions laid down in Articles 228 and 263 TFEU respectively. SECTION 4 Financial requirements Article 115 Budget 1. The revenue of the Agency shall consist, without prejudice to other types of income, of: (a) a contribution from the Union entered in the general budget of the European Union (Commission section); (b) a contribution from the countries associated with the implementation, application and development of the Schengen acquis, as established in the respective arrangements that specify their financial contribution; (c) Union funding in the form of contribution agreements or ad-hoc grants in accordance with the Agency's financial rules referred to in Article 120 and with the provisions of the relevant instruments supporting the policies of the Union; (d) fees for services provided; (e) any voluntary contribution from the Member States. 2. The expenditure of the Agency shall include its administrative, infrastructure, operational and staff-related expenses. 3. The executive director shall draw up a draft statement of estimates of the Agency's revenue and expenditure for the following financial year, including an establishment plan, and shall forward it to the management board. 4. Revenue and expenditure shall be balanced. 5. The management board shall, on the basis of the draft statement of estimates drawn up by the executive director, adopt a provisional draft estimate of the Agency's revenue and expenditure, including the provisional establishment plan. The management board shall forward them to the European Parliament, to the Council and to the Commission by 31 January every year, as part of the draft single programming document. 6. The management board shall send the final draft estimates of the Agency's revenue and expenditure including the draft establishment plan accompanied by the preliminary work programme to the Commission by 31 March every year. 7. The estimate shall be forwarded by the Commission to the budgetary authority together with the draft general budget of the European Union. 8. On the basis of the estimate, the Commission shall enter in the draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the contribution to be charged to the general budget, which it shall place before the budgetary authority in accordance with Articles 313 and 314 TFEU. 9. The budgetary authority shall authorise appropriations for the contribution to the Agency. 10. The budgetary authority shall adopt the establishment plan for the Agency. 11. The management board shall adopt the Agency's budget. It shall become final following final adoption of the general budget of the European Union. Where appropriate, it shall be adjusted accordingly. 12. Any modification to the budget, including the establishment plan, shall follow the same procedure. 13. For any building project likely to have significant implications for the budget of the Agency, the provisions of Commission Delegated Regulation (EU) 2019/715 (47) shall apply. 14. To finance the deployment of rapid border interventions and return interventions, the budget of the Agency adopted by the management board shall include a financial operational reserve amounting to at least 2 % of the allocation provided jointly for joint operations at the external borders and operational activities in the area of return. After the end of each month, the executive director may decide to reallocate a sum equivalent to one twelfth of the appropriations of the reserve to other operational activities of the Agency. In such a case, the executive director shall inform the management board. 15. Budgetary commitments for actions extending over more than one financial year may be broken down over several years into annual instalments. Article 116 Implementation and control of the budget 1. The executive director shall implement the Agency's budget. 2. By 1 March of a financial year N + 1, the Agency's accounting officer shall communicate the provisional accounts for the financial year N to the Commission's accounting officer and to the Court of Auditors. The Commission's accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 245 of Regulation (EU, Euratom) 2018/1046. 3. The Agency shall send a report on the budgetary and financial management for year N to the European Parliament, to the Council and to the Court of Auditors by 31 March of year N + 1. 4. The Commission's accounting officer shall send the Agency's provisional accounts for year N, consolidated with the Commission's accounts, to the Court of Auditors by 31 March of year N + 1. 5. On receipt of the Court of Auditors' observations on the Agency's provisional accounts for year N, pursuant to Article 246 of Regulation (EU, Euratom) 2018/1046, the executive director shall draw up the Agency's final accounts under his or her own responsibility and forward them to the management board for an opinion. 6. The management board shall deliver an opinion on the Agency's final accounts for year N. 7. By 1 July of year N + 1, the executive director shall send the final accounts, together with the opinion of the management board, to the European Parliament, to the Council, to the Commission and to the Court of Auditors. 8. The final accounts for year N shall be published in the Official Journal of the European Union by 15 November of year N + 1. 9. The executive director shall send the Court of Auditors a reply to its observations by 30 September of year N + 1. He or she shall also send this reply to the management board. 10. The executive director shall submit to the European Parliament, at the latter's request, any information required for the smooth application of the discharge procedure for year N, in accordance with Article 261(3) of Regulation (EU, Euratom) 2018/1046. 11. On a recommendation from the Council acting by qualified majority, the European Parliament shall, before 15 May of the year N + 2, give a discharge to the executive director in respect of the implementation of the budget for the year N. Article 117 Combating fraud 1. In order to combat fraud, corruption and other illegal activities, the provisions of Regulation (EU, Euratom) No 883/2013 shall apply without restriction. The Agency shall accede to the Interinstitutional Agreement of 25 May 1999 concerning internal investigations by the European Anti-Fraud Office (OLAF) and shall adopt, without delay, the appropriate provisions applicable to all staff of the Agency using the template set out in the Annex to that Agreement. 2. The Court of Auditors shall have the power of audit, on the basis of documents and of on-the-spot inspections, over all grant beneficiaries, contractors and subcontractors who have received Union funds from the Agency. 3. OLAF may carry out administrative investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 and Council Regulation (Euratom, EC) No 2185/96 (48) with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded by the Agency. 4. In accordance with Regulation (EU) 2017/1939, the European Public Prosecutor's Office (EPPO) may investigate and prosecute fraud and other illegal activities affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371. 5. Without prejudice to paragraphs 1 to 4, working arrangements with third countries and with international organisations, grant agreements, grant decisions and contracts of the Agency shall contain provisions expressly empowering the Court of Auditors, OLAF and EPPO to conduct such audits and investigations, in accordance with their respective competences. Article 118 Prevention of conflicts of interest The Agency shall adopt internal rules requiring the members of its bodies and its staff to avoid any situation liable to give rise to a conflict of interest during their employment or term of office and to report such situations. The Agency shall ensure that there is transparency as regards lobbying by means of a transparency register and by disclosing all its meetings with third-party stakeholders. The transparency register shall include all meetings and contacts between third-party stakeholders and the executive director, deputy executive directors and heads of division in matters concerning procurements and tenders for services, equipment or outsourced projects and studies. The Agency shall keep a record of all meetings of its staff with third-party stakeholders in matters concerning procurements and tenders for services, equipment or outsourced projects and studies. Article 119 Administrative inquiries The activities of the Agency shall be subject to the inquiries of the European Ombudsman in accordance with Article 228 TFEU. Article 120 Financial provision The financial rules applicable to the Agency shall be adopted by the management board after consulting the Commission. They shall not depart from Delegated Regulation (EU) No 1271/2013 unless such a departure is specifically required for the Agency's operation and the Commission has given its prior consent. In this framework, the management board shall adopt specific financial rules applicable to the Agency's activities in the area of cooperation with third countries in the field of return. Article 121 Evaluation 1. Without prejudice to Article 59, by 5 December 2023, and every four years thereafter, the Commission shall carry out an evaluation of this Regulation. The evaluation shall assess in particular: (a) the results achieved by the Agency, having regard to its objectives, mandate, resources and tasks; (b) the impact, effectiveness and efficiency of the Agency's performance and its working practices in relation to its objectives, mandate and tasks; (c) inter-agency cooperation at the European level, including the implementation of European cooperation on coast guard functions; (d) the possible need to modify the mandate of the Agency; (e) the financial implications of any such modification; (f) the functioning of the standing corps and, as from the second evaluation, its overall number and composition; (g) the level of training, specialised expertise and professionalism of the standing corps. The evaluation shall include a specific analysis on the way the Charter and other relevant Union law has been complied with in the application of this Regulation. 2. The evaluation shall also assess the attractiveness of the Agency as an employer for the recruitment of statutory staff, with a view of ensuring quality of the candidates and geographical balance. 3. When carrying out the evaluation, the Commission shall seek input from relevant stakeholders, including the consultative forum and FRA. 4. The Commission shall send the evaluation reports together with its conclusions on the reports to the European Parliament, to the Council and to the management board. The management board may issue recommendations regarding changes to this Regulation to the Commission. The evaluation reports and the conclusions on the reports shall be made public. The Member States and the Agency shall provide the Commission with the information necessary to draft the evaluation reports. Where necessary, the evaluation reports shall be accompanied by legislative proposals. 5. The Agency shall submit a report to the European Parliament and to the Council on the functioning of EUROSUR by 1 December 2021 and every two years thereafter. Member States shall provide the Agency with the information necessary to draft those reports. 6. As part of the evaluation referred to in paragraph 1, the Commission shall provide an overall evaluation of EUROSUR accompanied, where necessary, by appropriate proposals to improve its functioning. The Member States and the Agency shall provide the Commission with the information necessary to produce the overall evaluation referred to in the first subparagraph. When carrying out the overall evaluation referred to in the first subparagraph, the Commission shall seek input from relevant stakeholders, including the consultative forum and FRA. CHAPTER V FINAL PROVISIONS Article 122 Committee procedure 1. The Commission shall be assisted by a committee (‘the European Board and Coast Guard Committee’). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 123 Repeal and transitional provisions 1. Regulation (EU) No 1052/2013 is repealed with the exception of Article 9(3), (5), (7) to (10) and Article 10(5) and (7) thereof, which are repealed with effect from the date of the entry into force of the implementing act referred to in Article 24(3) of this Regulation. 2. Regulation (EU) 2016/1624 is repealed with the exception of Articles 20, 30 and 31 thereof, which are repealed with effect from 1 January 2021. 3. Deployments in accordance with Article 54 to 58 shall take place as of 1 January 2021. 4. For the deployments in 2021, the management board shall adopt the decisions referred to Article 54(4) and Article 64(6) by 31 March 2020. 5. For the purpose of supporting the development of human resources to secure the contributions of the Member States to the standing corps, Member States shall be entitled to receive funding in 2020 in accordance with point (a) of Article 61(1). The numbers in Annex II for 2022 shall be used as a reference for the relevant funding in 2020. 6. In order to effectively contribute the required numbers of statutory staff to the first deployments of the standing corps and the setting up of the ETIAS Central Unit, the Agency shall launch the necessary preparations, including recruitment and training, as of 4 December 2019 and in accordance with the budgetary rules. 7. Until 5 December 2021, Member States may provide information to EUROSUR on border checks and air border surveillance on a voluntary basis. 8. References to the repealed acts shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VI to this Regulation. Article 124 Entry into force and applicability 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. Article 79 shall apply from the date of the effective transfer of the system referred to in that Article. 3. Article 12(3), Article 70 and Article 100(5), insofar as they concern the cooperation with the United Kingdom, shall apply until the day on which the Treaties cease to apply to the United Kingdom pursuant to Article 50(3) TEU or, provided that a withdrawal agreement concluded with the United Kingdom in accordance with Article 50(2) TEU has entered into force by that date, until the end of the transition period set in that withdrawal agreement. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Brussels, 13 November 2019. For the European Parliament The President D. M. SASSOLI For the Council The President T. TUPPURAINEN (1) OJ C 110, 22.3.2019, p. 62. (2) OJ C 168, 16.5.2019, p. 74. (3) Position of the European Parliament of 17 April 2019 (not yet published in the Official Journal) and decision of the Council of 8 November 2019. (4) Council Regulation (EC) No 2007/2004 of 26 October 2004 establishing a European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (OJ L 349, 25.11.2004, p. 1). (5) Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, p. 1). (6) Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1). (7) Regulation (EU) No 656/2014 of the European Parliament and of the Council of 15 May 2014 establishing rules for the surveillance of the external sea borders in the context of operational cooperation coordinated by the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (OJ L 189, 27.6.2014, p. 93). (8) Regulation (EU) No 1052/2013 of the European Parliament and of the Council of 22 October 2013 establishing the European Border Surveillance System (Eurosur) (OJ L 295, 6.11.2013, p. 11). (9) Council Directive 2002/90/EC of 28 November 2002 defining the facilitation of unauthorised entry, transit and residence (OJ L 328, 5.12.2002, p. 17). (10) Council Regulation (EU) No 1053/2013 of 7 October 2013 establishing an evaluation and monitoring mechanism to verify the application of the Schengen acquis and repealing the Decision of the Executive Committee of 16 September 1998 setting up a Standing Committee on the evaluation and implementation of Schengen (OJ L 295, 6.11.2013, p. 27). (11) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (12) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, p. 98). (13) Joint Action 98/700/JHA of 3 December 1998 adopted by the Council on the basis of Article K.3 of the Treaty on European Union concerning the setting up of a European Image Archiving System (FADO) (OJ L 333, 9.12.1998, p. 4). (14) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (15) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (16) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (17) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (18) OJ L 136, 31.5.1999, p. 15. (19) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor's Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1). (20) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union's financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (21) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (22) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (23) OJ L 176, 10.7.1999, p. 36. (24) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31). (25) OJ L 188, 20.7.2007, p. 19. (26) OJ L 53, 27.2.2008, p. 52. (27) Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1). (28) OJ L 160, 18.6.2011, p. 21. (29) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19). (30) OJ L 243, 16.9.2010, p. 4. (31) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43). (32) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20). (33) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (34) OJ L 56, 4.3.1968, p. 1. (35) Regulation (EU) 2019/1240 of the European Parliament and of the Council of 20 June 2019 on the creation of a European network of immigration liaison officers (OJ L 198, 25.7.2019, p. 88). (36) Council Decision 2008/381/EC of 14 May 2008 establishing a European Migration Network (OJ L 131, 21.5.2008, p. 7). (37) Regulation (EU) 2018/1240 of the European Parliament and of the Council of 12 September 2018 establishing a European Travel Information and Authorisation System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014, (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, p. 1). (38) Regulation (EU) No 1285/2013 of the European Parliament and of the Council of 11 December 2013 on the implementation and exploitation of European satellite navigation systems and repealing Council Regulation (EC) No 876/2002 and Regulation (EC) No 683/2008 of the European Parliament and of the Council (OJ L 347, 20.12.2013, p. 1). (39) Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals (OJ L 312, 7.12.2018, p. 1). (40) Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1). (41) Regulation (EU) No 603/2013 of the European Parliament and of the Council of 26 June 2013 on the establishment of ‘Eurodac’ for the comparison of fingerprints for the effective application of Regulation (EU) No 604/2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person and on requests for the comparison with Eurodac data by Member States' law enforcement authorities and Europol for law enforcement purposes, and amending Regulation (EU) No 1077/2011 establishing a European Agency for the operational management of large-scale IT systems in the area of freedom, security and justice (OJ L 180, 29.6.2013, p. 1). (42) Regulation (EU) No 515/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for external borders and visa and repealing Decision No 574/2007/EC (OJ L 150, 20.5.2014, p. 143). (43) Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60). (44) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41). (45) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). (46) Regulation No 1 of 15 April 1958 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385). (47) Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (OJ L 122, 10.5.2019, p. 1). (48) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). ANNEX I Capacity of the standing corps per year and category in accordance with Article 54 Category/Year Category 1 Statutory staff Category 2 Operational staff for long-term secondments Category 3 Operational staff for short-term deployments Category 4 Reserve for rapid reaction Total for the standing corps 2021 1 000 400 3 600 1 500 6 500 2022 1 000 500 3 500 1 500 6 500 2023 1 500 500 4 000 1 500 7 500 2024 1 500 750 4 250 1 500 8 000 2025 2 000 1 000 5 000 0 8 000 2026 2 500 1 250 5 250 0 9 000 2027 and beyond 3 000 1 500 5 500 0 10 000 ANNEX II Annual contributions to be provided by Member States to the standing corps through the long-term secondment of staff in accordance with Article 56 Country/Year 2021 2022 2023 2024 2025 2026 2027 and beyond Belgium 8 10 10 15 20 25 30 Bulgaria 11 13 13 20 27 33 40 Czech Republic 5 7 7 10 13 17 20 Denmark 8 10 10 15 19 24 29 Germany 61 73 73 110 152 187 225 Estonia 5 6 6 9 12 15 18 Greece 13 17 17 25 33 42 50 Spain 30 37 37 56 74 93 111 France 46 56 56 83 114 141 170 Croatia 17 22 22 33 43 54 65 Italy 33 42 42 63 83 104 125 Cyprus 2 3 3 4 5 7 8 Latvia 8 10 10 15 20 25 30 Lithuania 10 13 13 20 26 33 39 Luxembourg 2 3 3 4 5 7 8 Hungary 17 22 22 33 43 54 65 Malta 2 2 2 3 4 5 6 Netherlands 13 17 17 25 33 42 50 Austria 9 11 11 17 23 28 34 Poland 27 33 33 50 67 83 100 Portugal 8 10 10 15 20 25 30 Romania 20 25 25 38 50 63 75 Slovenia 9 12 12 18 23 29 35 Slovakia 9 12 12 18 23 29 35 Finland 8 10 10 15 20 25 30 Sweden 9 11 11 17 23 28 34 Switzerland 4 5 5 8 11 13 16 Iceland 1 1 1 1 1 2 2 Liechtenstein (*1) 0 0 0 0 0 0 0 Norway 5 7 7 10 13 17 20 TOTAL 400 500 500 750 1 000 1 250 1 500 (*1) Liechtenstein will contribute through proportional financial support. ANNEX III Annual contributions to be provided by Member States to the standing corps for short-term deployments of staff in accordance with Article 57 Country/Year 2021 2022 2023 2024 2025 2026 2027 and beyond Belgium 72 70 80 85 100 105 110 Bulgaria 96 93 107 113 133 140 147 Czech Republic 48 47 53 57 67 70 73 Denmark 70 68 77 82 97 102 106 Germany 540 523 602 637 748 785 827 Estonia 43 42 48 51 60 63 66 Greece 120 117 133 142 167 175 183 Spain 266 259 296 315 370 389 407 France 408 396 454 481 566 593 624 Croatia 156 152 173 184 217 228 238 Italy 300 292 333 354 417 438 458 Cyprus 19 19 21 23 27 28 29 Latvia 72 70 80 85 100 105 110 Lithuania 94 91 104 111 130 137 143 Luxembourg 19 19 21 23 27 28 29 Hungary 156 152 173 184 217 228 238 Malta 14 14 16 17 20 21 22 Netherlands 120 117 133 142 167 175 183 Austria 82 79 91 96 113 119 125 Poland 240 233 267 283 333 350 367 Portugal 72 0 80 85 100 105 110 Romania 180 175 200 213 250 263 275 Slovenia 84 82 93 99 117 123 128 Slovakia 84 82 93 99 117 123 128 Finland 72 70 80 85 100 105 110 Sweden 82 79 91 96 113 119 125 Switzerland 38 37 43 45 53 56 59 Iceland 5 5 5 6 7 7 7 Liechtenstein (*1) 0 0 0 0 0 0 0 Norway 48 47 53 57 67 70 73 TOTAL 3 600 3 500 4 000 4 250 5 000 5 250 5 500 (*1) Liechtenstein will contribute through proportional financial support. ANNEX IV Contributions to be provided by Member States to the standing corps through the reserve for rapid reaction in accordance with Article 58 Country Number Belgium 30 Bulgaria 40 Czech Republic 20 Denmark 29 Germany 225 Estonia 18 Greece 50 Spain 111 France 170 Croatia 65 Italy 125 Cyprus 8 Latvia 30 Lithuania 39 Luxembourg 8 Hungary 65 Malta 6 Netherlands 50 Austria 34 Poland 100 Portugal 30 Romania 75 Slovenia 35 Slovakia 35 Finland 30 Sweden 34 Switzerland 16 Iceland 2 Liechtenstein (*1) 0 Norway 20 TOTAL 1 500 (*1) Liechtenstein will contribute through proportional financial support. ANNEX V Rules on the use of force, including training and the supply, control and use of service weapons and non-lethal equipment, applicable to statutory staff deployed as members of the teams 1. General Principles Governing the Use of Force and Weapons For the purposes of this Regulation, ‘use of force’ refers to recourse by statutory staff deployed as members of the teams to physical means for the purposes of performing their functions or ensuring self-defence, which includes the use of hands and body and the use of any instruments, weapons, including firearms, or equipment. Weapons, ammunition and equipment shall only be carried and used during operations. Carrying or using weapons, ammunition and equipment during off duty periods shall be prohibited. In accordance with Article 82(8), the use of force and weapons by statutory staff deployed as members of the teams shall be exercised in accordance with the national law of the host Member State, in the presence of border guards of the host Member State. Without prejudice to the authorisation by the host Member State and the applicability of its national law to the use of force during operations, the use of force and weapons by statutory staff deployed as members of the teams shall comply with the principles of necessity, proportionality and precaution (the ‘core principles’) as set out below. The operational plan agreed between the executive director and the host Member State shall define the conditions for carrying and using weapons in accordance with national law or operating procedures during operations. The Principle of Necessity The use of force, whether through direct physical contact or by the use of weapons or equipment, shall be exceptional and shall only take place where it is strictly necessary to ensure the performance of the Agency’s duties or in self-defence. Force shall only be used as a last resort, after every reasonable effort has been made to resolve a situation using non-violent means, including by means of persuasion, negotiation, or mediation. The use of force or coercive measures shall never be arbitrary or abusive. The Principle of Proportionality Whenever the lawful use of force or firearms is unavoidable, statutory staff deployed as members of the teams shall act in proportion to the seriousness of the situation and the legitimate objective to be achieved. During operational activities, the proportionality principle shall guide both the nature of the force used (e.g. the need for the use of weapons) as well as the extent of the force applied. Statutory staff deployed as members of the teams shall not use more force than is absolutely necessary to achieve the legitimate law enforcement objective. If a firearm is used, statutory staff deployed as members of the teams shall ensure that such use causes the least possible injury and minimises injury and damage to the greatest possible extent. Where the measures lead to an unacceptable result, statutory staff deployed as members of the teams may waive the measure. The principle of proportionality requires the Agency to provide equipment and self-defensive tools to statutory staff deployed as members of the teams which are necessary to enable the appropriate level of force to be applied. The Duty of Precaution Operational activities carried out statutory staff deployed as members of the teams shall fully respect and aim to preserve human life and human dignity. All necessary steps that can minimise the risk of injury and damage during operations shall be taken. This obligation includes a general obligation for statutory staff deployed as members of the teams to give clear warnings of their intention to use force, unless giving such a warning would unduly place the members of the teams at risk or would create a risk of death or serious harm to others, or would be clearly inappropriate or ineffective in the particular circumstances. 2. Specific rules for the most commonly used instruments of force (equipment of statutory staff deployed as members of the teams) In accordance with the core principles, the use of force shall only be permissible to the extent that the use of force is necessary for achieving the immediate law enforcement aim, and only after: — attempts to resolve a potentially violent confrontation by means of persuasion, negotiation, mediation have been exhausted and failed, — a warning of the intention to use force has been given. Where it is necessary to escalate the level of intervention (for example, using a weapon or a different kind of weapon), clear warning of such an escalation shall also be given unless giving such a warning would unduly place members of teams at risk or would create a risk of death or serious harm to others, or would be clearly inappropriate or ineffective in the particular circumstances. Firearms Statutory staff deployed as members of the teams shall not use firearms against persons, except in the following circumstances, and only when less extreme means are insufficient to achieve the necessary objectives: — the use of firearms by statutory staff deployed as members of the teams is a last resort in an extreme emergency, especially if there is any risk that bystanders might be endangered, — the use of firearms by statutory staff deployed as members of the teams is necessary to defend themselves or others against an imminent threat of death or serious injury, — the use of firearms by statutory staff deployed as members of the teams is to prevent an imminent threat of death or serious injury, — the use of firearms by statutory staff deployed as members of the teams is to repel an actual attack or prevent an impending dangerous attack on essential institutions, services or facilities. Prior to the use of firearms, statutory staff deployed as members of the teams must give a clear warning of their intention to use such firearms. Warnings may be given orally or by the firing of warning shots. Non-lethal weapons Baton Approved batons may be used as a means of defence or as a weapon, as appropriate, in line with the core principles, as follows: — when lesser use of force is considered clearly unsuitable for the purpose, — to avert an actual or impending attack on property. Prior to the use of batons, statutory staff deployed as members of the teams must give a clear warning of their intention to use batons. In using batons, statutory staff deployed as members of the teams shall always aim to minimise the risk of injury suffered and avoid contact with the head. Lachrymatory agents (e.g. pepper spray) Approved lachrymatory agents may be used as a means of defence or as a weapon, as appropriate, in line with the core principles, as follows: — when lesser use of force is considered clearly unsuitable for the purpose, — to avert an actual or impending attack. Other equipment Handcuffs Handcuffs shall only be placed on persons who are considered to present a danger to themselves or to others, in order to ensure their safe detention or transportation and to ensure the safety of statutory staff deployed as members of the teams and other members of the teams. Handcuffs shall only be used for the shortest time possible and only where strictly necessary. 3. Practical rules on the use of force, service weapons, ammunition and equipment during operations General practical rules on the use of force, weapons and other equipment during operations In accordance with Article 82(8), statutory staff deployed as members of the teams are to exercise their executive power, including the use of force, under the command and control of the host Member State, and shall only use force, including using weapons, ammunition and equipment, in the presence of the border guards of the host Member State following the authorisation of the competent authorities of the host Member State. Nevertheless, the competent authorities of the host Member State may authorise statutory staff deployed as members of the teams, with the consent of the Agency, to use force in the absence of officers of the host Member State. The host Member State may prohibit the carrying of certain service weapons, ammunition and equipment in accordance with the second subparagraph of Article 82(8). Without prejudice to the authorisation by the host Member State and the applicability of its national law to the use of force during operations, the use of force and weapons by statutory staff deployed as members of the teams shall: (a) comply with the core principles and specific rules referred to in Part 2; (b) respect fundamental rights as guaranteed under international and Union law, including, in particular, under the Charter, the European Convention for the Protection of Human Rights and Fundamental Freedoms, the United Nations Basic Principles on the Use of Force and Firearms by Law Enforcement Officials, and the United Nations Code of Conduct for Law Enforcement Officials; (c) comply with the Agency’s code of conduct. 4. Control Mechanism The Agency shall provide the following safeguards in relation to the use of force, weapons, ammunition and equipment, and shall provide a stocktaking in its annual report. Training The training provided in accordance with Article 62(2) shall cover theoretical and practical aspects in relation to the prevention of and use of force. The theoretical training shall incorporate psychological training, including training in resilience and working in situations of high pressure, as well as techniques for avoiding the use of force, such as negotiation and mediation. The theoretical training shall be followed by obligatory and adequate theoretical and practical training on the use of force, weapons, ammunition and equipment and on applicable fundamental rights safeguards. In order to ensure a common practical understanding and approach, the practical training shall end with a simulation relevant to the activities to be carried out during the deployment and shall include a practical simulation involving the operationalisation of fundamental rights safeguards. The Agency shall provide statutory staff deployed as members of the teams with annual ongoing training on the use of force. Such training shall take place as per the training provided for in Article 62(2). In order for statutory staff deployed as members of the teams to be permitted to carry service weapons and to use force, they shall be required to have successfully completed the annual ongoing training. The annual ongoing training shall cover theoretical and practical aspects as described in the first paragraph. The annual ongoing training shall last at least 24 hours in total, with the theoretical training taking at least 8 hours and the practical training taking at least 16 hours. The practical training shall be divided into at least 8 hours for physical training, using physical restraint techniques, and at least 8 hours for the use of firearms. Use of narcotics, drugs and alcohol consumption Statutory staff deployed as members of the teams shall not consume or be under the influence of alcohol while on duty. Statutory staff deployed as members of the teams shall not possess or use narcotics or drugs, unless prescribed on medical grounds. Statutory staff deployed as members of the teams requiring drugs for medical purposes shall immediately inform their immediate superior of such a requirement. Their participation in operational activities may be reviewed having regard to potential effects and side-effects associated with the use of the substance. The Agency shall establish a control mechanism to ensure that its statutory staff deployed as members of the teams do not carry out their functions under the influence of narcotics, drugs or alcohol. That mechanism shall be based on regular medical testing of statutory staff deployed as members of the teams in order to identify any possible consumption of narcotics, drugs or alcohol. Any positive test results shall be immediately reported to the executive director. Reporting Any incidents involving the use of force shall be immediately reported through the chain of command to the coordination structure relevant for each operation and to the fundamental rights officer and the executive director. The report shall provide full details of the circumstances in which such use arose. Duty to cooperate and inform Statutory staff deployed as members of the teams and any other participants in operations shall cooperate in the gathering of facts related to any incident which was reported during an operational activity. Supervisory mechanism The Agency shall establish a supervisory mechanism as referred to in point (a) of Article 55(5). Complaints mechanism Any person may report suspected breaches by statutory staff deployed as members of the teams of the rules on the use of force applicable under this Annex through the complaints mechanism provided for in Article 111. Sanctions Without prejudice to Article 85, where the Agency establishes that a member of its statutory staff deployed as a member of the teams has performed activities in breach of the rules applicable under this Regulation, including fundamental rights protected under the Charter, the European Convention for the Protection of Human Rights and Fundamental Freedoms and international law, the executive director shall take adequate measures, which may include the immediate recall of that statutory staff member from the operational activity, and any disciplinary measures in accordance with the Staff Regulations, including the removal of the statutory staff member from the Agency. Role of the fundamental rights officer The fundamental rights officer shall verify and provide feedback on the content of induction and refresher training paying special regard to aspects relating to fundamental rights and how fundamental rights can be protected in situations where the use of force is necessary, and ensure relevant preventive techniques are included. The fundamental rights officer shall report on the respect for fundamental rights within the law enforcement practices of the host Member State or host third country. That report shall be submitted to the executive director and shall be taken into account in the design of the operational plan. The fundamental rights officer shall ensure that incidents related to the use of force and use of weapons, ammunition and equipment are thoroughly investigated and reported without delay to the executive director. The results of such investigations shall be transmitted to the consultative forum. All activities related to the use of force, weapons, ammunition and equipment shall be regularly monitored by the fundamental rights officer, and all incidents shall be reported in the fundamental rights officer’s reports as well in the annual report of the Agency. 5. Provision of service weapons Authorisation of weapons For the purposes of determining the exact service weapons, ammunition and other equipment to be used by statutory staff deployed as members of the teams, the Agency shall establish an exhaustive list of items to be included in personal equipment sets. Personal equipment sets shall be used by all statutory staff deployed as members of the teams. The Agency may also complement personal equipment sets with additional weapons, ammunition or other equipment specific for the purpose of carrying out specific tasks within one or two types of teams. The Agency shall ensure that all weapons, including firearms, ammunition and equipment provided to statutory staff deployed as members of the teams comply with all the necessary technical standards. Weapons, ammunition and equipment that are authorised for use shall be listed in the operational plan in line with the requirements on admissible and prohibited weapons of the host Member State. Instructions for duty period Weapons, ammunition and equipment may be carried during operations and shall be used only as measures of last resort. Carrying or using weapons, ammunition and equipment during off-duty periods shall not be allowed. The Agency shall establish specific rules and measures to facilitate the storage of weapons, ammunition and other equipment of statutory staff deployed as members of the teams during off-duty periods in secured facilities as referred to in point (c) of Article 55(5). ANNEX VI Correlation Table Regulation (EU) 2016/1624 Regulation (EU) No 1052/2013 This Regulation Article 1, first sentence — Article 1, first paragraph Article 1, second sentence — Article 1, second paragraph Article 2, point (1) — Article 2, point 1 — — Article 2, points (2), (4), (5), (6), (9)(15), (16), (17), (18), (29), and (30) Article 2, point (2) — Article 2, point (3) — Article 3, points (b), (c), (d), (f) and (g) Article 2, points (7), (8), (10), (11), and (13) Article 2, point (16) Article 3, point (e) Article 2, point (12) — Article 3, point (i) Article 2, point (14) Article 2, point (9) — Article 2, point (19) Article 2, points (5) to (7) — Article 2, points (20) to (22) Article 2, points (10) to (15) — Article 2, points (23) to (28) Article 4, points (a) to (d) — Article 3(1), points (a) to (d) Article 4, point (e) — Article 3(1), points (e) and (f) Article 4, points (f) to (k) — Article 3(1), points (g) to (l) — — Article 3(2) Article 3(1) — Article 4 Article 6 — Article 5 Article 7 — Article 6 Article 5(1) — Article 7(1) — — Article 7(2) Article 5(2) and (3) — Article 7(3) and (4) Article 8(2) — Article 7(5) — — Article 8(1) to (4) Article 3(2) — Article 8(5) Article 3(3) — Article 8(6) — — Article 8(7) and (8) — — Article 9 Article 8(1), point (a) — Article 10(1), point (a) — — Article 10(1), point (b) Article 8(1), point (b) — Article 10(1), point (c) Article 8(1), point (c) — Article 10(1), point (d) — — Article 10(1), point (e) Article 8(1), point (s) — Article 10(1), point (f) Article 8(1), point (d) — Article 10(1), point (g) Article 8(1), point (e) — Article 10(1), point (h) Article 8(1), point (f) — Article 10(1), point (i) Article 8(1), point (g) — Article 10(1), point (j) Article 8(1), point (h) — Article 10(1), point (k) — — Article 10(1), point (l) Article 8(1), point (i) — Article 10(1), point (m) Article 8(1), point (l) — Article 10(1), point (n) Article 8(1), point (n) — Article 10(1), point (o) Article 8(1), point (o) — Article 10(1), point (p) Article 8(1), point (m) — Article 10(1), point (q) — — Article 10(1), points (r) and (s) Article 8(1), point (t) — Article 10(1), point (t) — — Article 10(1), point (u) Article 8(1), point (u) — Article 10(1), point (v) Article 8(1), point (p) — Article 10(1), point (w) Article 8(1), point (q) — Article 10(1), point (x) — — Article 10(1), point (y) Article 8(1), point (j) — Article 10(1), point (z) — Article 6(1), point (a) Article 10(1), point (aa) Article 8(1), point (r) — Article 10(1), point (ab) Article 8(1), point (s) — Article 10(1), point (ac) — — Article 10(1), points (ad) to (ag) Article 8(3) — Article 10(2) Article 9 — Article 11 Article 10 — Article 12(1) — — Article 12(2) and (3) Article 23 — Article 13(1), (first sentence) — — Article 13(1), second sentence — — Article 13(2) and (3) — Article 7(1) Article 14(1) — Article 7(2) Article 14(2) Article 44(1) — Article 15(1) and (2) — — Article 15(3) — — Article 16 — — Article 17 — Article 1 Article 18 — Article 2(1) and (2) Article 19(1) — Article 2(3) Article 19(2) — Article 4(1), points (a) and (b) Article 20(1), points (a) and (b) — Article 4(1), point (d) Article 20(1), point (c) — — Article 20(1), points (d), (e) and (f) — Article 4(2) and (3) Article 20(2) and (3) — Article 5(1), (2) and (3) Article 21(1), (2) and (3), points (a) to (h) — — Article 21(3), points (i) and (j) — Article 17(1), (2), and (3) Article 21(4), (5), and (6) — Article 5(4) Article 21(7) — Article 21 Article 22 — Article 22(1) Article 23(1) — — Article 23(2) and (3) — Article 8(1) and (2) Article 24(1) — — Article 24(2) — — Article 24(3) — Article 9(1) Article 25(1) — Article 9(2), points (a) to (e) Article 25(2), points (a) to (e) — — Article 25(2), point (f) — Article 9(2), point (f) Article 25(2), point (g) — Article 9(2), point (g) Article 25(2), point (h) — Article 9(2), point (h) Article 25(2), point (i) — Article 9(2), point (i) Article 25(2), point (j) — Article 9(2), point (j) Article 25(2), point (k) — Article 9(2), point (k) Article 25(2), point (l) — Article 9(4) Article 25(3) — Article 9(5), point (a), second sentence Article 25(4) — Article 9(10) Article 25(5) — Article 10(1) Article 26(1) — Article 10(2), points (a) and (b) Article 26(2), points (a) and (b) — Article 10(2), point (d) Article 26(2), point (c) — Article 10(2), point (e) Article 26(2), point (d) — — Article 26(2), point (e) — Article 10(2), point (f) Article 26(2), point (f) — Article 10(3), point (a) Article 26(3), point (a) — — Article 26(3), point (b) — Article 10(3), point (c) Article 26(3), point (c) — Article 10(5) Article 26(4) — Article 10(6) Article 26(5) — Article 10(4) Article 26(6) — — Article 27 — Article 12(1) Article 28(1) — Article 12(2), points (a), (b), and (c) Article 28(2), points (a), (b) and (c) — — Article 28(2), point (d) — Article 12(2), point (d) Article 28(2), point (e) — Article 12(2), point (e) Article 28(2), point (f) — — Article 28(2), points (g), (h) and (i) — Article 12(4) and (5) Article 28(3) and (4) Article 11 — Article 29(1), (2), (3) and (5) to (8) — — Article 29(4) — Article 14 Article 30 Article 12 — Article 31(1), (2) and (4) to (7), and Article 31(3), points (a) to (e), and (g) to (j) — — Article 31(3), points (f) and (k) Article 13 — Article 32(1) to (8), (10) and (11) — — Article 32(9) — — Article 33 — Article 15(1) Article 34(1) — — Article 34(2) — — Article 34(3) — Article 15(2) Article 34(4) — Article 15(3) Article 34(5) — Article 16(1), (2), and (3) Article 35(1), points (a), (b) and (c) and Article 35(2)and (3) — — Article 35(1), point (d) — Article 16(5) Article 35(4) Article 14 — Article 36(1), (3) and (4) and Article 36(2) points (a) to (e) — Article 16(4), point (a) Article 36(2), point (f) Article 15(1), (2), and (3) — Article 37(1), (2), and (3) Article 15(5) — Article 37(4) Article 16 — Article 38(1), (2) and (4) and Article 38(3), points (a) to (k) and points (m) to (o) — — Article 38(3), point (l) and Article 38(5) Article 17 — Article 39(1), (2), (3), (5), (7) to (10) and (13) to (15) — — Article 39(4), (6), (11) and (12) Article 18 — Article 40(1), (2), (3) and (5) and Article 40(4), points (a), (b) and (c) — — Article 40(4), point (d) Article 15(4) — Article 41(1) — — Article 41(2) Article 19 — Article 42 Article 21 — Article 43(1) to (5) — — Article 43(6) Article 22 — Article 44 Article 24(1), points (a) to (e) and Article 24(2) — Article 45(1) — — Article 45(2) Article 25 — Article 46(1) to (4) and (7) — — Article 46(5) and (6) Article 26 — Article 47 Article 27(1), point (a) — Article 48(1), point (a)(i) Article 27(1), point (c) — Article 48(1), point (a) (ii) and(iii) — — Article 48(1), point (a)(iv) Article 27(1), point (b) — Article 48(1), point (b) — — Article 48(1), points (c) and (d) Article 27(1), point (d) — Article 48(1), point (e) Article 27(1), point (e) — Article 48(1), point (f) Article 27(2) — Article 48(2), points (a) to (d) — — Article 48(2), point (e) Article 27(3) — Article 48(3) — — Article 49 Article 28 — Article 50 Article 29 — Article 51 — — Article 52(1) Article 32(2) — Article 52(2) Article 33 — Article 53 — — Article 54 — — Article 55 — — Article 56 — — Article 57 — — Article 58 — — Article 59 — — Article 60 — — Article 61 Article 36(1) — Article 62(1) — — Article 62(2) and (3) Article 36(2) — Article 62(4) Article 36(4) to (8) — Article 62(5) to (9) — — Article 62(10) Article 38(1) — Article 63(1) — — Article 63(2) Article 38(2) to (5) — Article 63(3) to (6) Article 39(1) to (12) and (14) to (16) — Article 64 — — Article 65(1) and (2) Article 20(12), Article 39(13) — Article 65(3) — — Article 65(4) Article 37 — Article 66(1) to (4) — — Article 66(5) — — Article 67 Article 52(1) Article 18(1), (2) and (3) Article 68(1), first subparagraph and second subparagraph, points (a) to (g) — — Article 68(1), point (i) and (j) — — Article 68(1), third subparagraph, points (a) to (d) — Article 18(3) Article 68(1), third subparagraph, point (e) Article 52(2) Article 18(5) Article 68(2) Article 52(4) Article 18(5) Article 68(3) Article 52(3) — Article 68(4) Article 52(4) Article 18(6) Article 68(5) — Article 18(4) Article 68(6) Article 53 — Article 69 Article 51(1) — Article 70(1) — Article 19 Article 70(2) to (6) Article 51(2) and (3) — Article 70(7) and (8) Article 54(1) and (2) — Article 71(1), (2) and (3) — — Article 71(4) — Article 20(1) Article 72(1) — — Article 72(2) — Article 20(3) Article 72(3) Article 54(2) — Article 73(1) and (2) Article 54(4) — Article 73(3) and (4) Article 54(8) — Article 73(5) Article 54(9) — Article 73(6) Article 54(11) — Article 73(7) and (8) Article 54(3) — Article 74(1), (2) and (3) — — Article 74(4), (5) and (6) — Article 20(1) Article 75(1) and (2) — Article 20(7) Article 75(3) Article 54(5) — Article 76(1) — — Article 76(2), (3) and (4) Article 55(4) — Article 76(5) Article 55(1), (2) and (3) — Article 77(1), (2) and (3) — — Article 77(4) Article 52(5) — Article 78(1) Article 54(7) — Article 78(2) — — Article 78(3) — — Article 79 Article 34 — Article 80 Article 35 — Article 81 Article 40 — Article 82(1), (3), (4) and (6) to (11) — — Article 82(2) and (5) Article 41 — Article 83 Article 42 — Article 84 Article 43 — Article 85 Article 45(1) and (2) — Article 86(1) and (2) — — Article 86(3), (4) and (5) Article 46(1) — Article 87(1), points (a), (b), (c), (e), (f), and (h) — — Article 87(1), points (d) and (g) Article 46(3) and (4) — Article 87(2) and (3) — — Article 88(1), first subparagraph Article 47(1), points (b) and (c) — Article 88(1), second subparagraph, points (a) and (c) — — Article 88(1), second subparagraph, point (b) Article 47(2) — Article 88(2), points (a) and (c) — — Article 88(2), point (b) — Article 13 Article 89(1) and (2) — — Article 89(3) — Article 20(4) and (5) Article 89(4) and (5) — — Article 89(6) — — Article 90 — — Article 91 Article 50 — Article 92 Article 56 — Article 93 Article 57 — Article 94 Article 58 — Article 95(1), (4), (5) and (6) — — Article 95(2) and (3) Article 59 — Article 96 Article 60 — Article 97 — — Article 98 Article 61 — Article 99 Article 62(1) and (3) to (8) — Article 100(1) and (3) to (8) Article 62(2), first subparagraph, points (a) to (g) and points (i) to (z) — Article 100(2), first subparagraph, points (a), (b), (d), (f) to (z) and point (ab) — — Article 100(2), first subparagraph, points (c), (e), (aa), (ac), (ad), (ae) Article 62(2), second subparagraph — Article 100(2), second subparagraph Article 63 — Article 101 Article 64 — Article 102 Article 65 — Article 103 Article 66 — Article 104(1) to (5) and (7) to (9) — — Article 104(6) Article 67 — Article 105 Article 68(1), (2) and (3), points (a) to (j) and points (l) to (r) — Article 106(1), (2), (5) and (6) and Article 106(4), points (a) to (l), (n), (o), (r), (s) and (t) — — Article 106(3) — — Article 106(4), points (m), (p) and (q) Article 69 — Article 107(1) to (7) — — Article 107(8) Article 70 — Article 108 Article 71 — Article 109(1), (4) and (7) — — Article 109(2), (3), (5)and (6) — — Article 110 Article 72 — Article 111 — — Article 112 Article 73 — Article 113 Article 74 — Article 114 Article 75 — Article 115(1) to (14) — — Article 115(15) Article 76 — Article 116 Article 77 — Article 117(1), (2), (3) and (5) — — Article 117(4) Article 78 — Article 118 — — Article 119 Article 79 — Article 120 Article 81(1) — Article 121(1), first subparagraph, points (a) to (e) and Article 121(1), second subparagraph — — Article 121(1), first subparagraph, points (f) and (g) — — Article 121(2) and (3) Article 81(2) — Article 121(4) — Article 22(2) Article 121(5) — Article 22(3) and (4) Article 121(6) — — Article 122 Article 82 — Article 123 Article 83 — Article 124 Article 2, points (3) and (4) — — Article 8(1), point (k) — — Article 8(1), points (t) and (u) — — Article 20(3) to (11) — — Article 27(1), point (c) — — Article 27(4) — — Article 30 — — Article 31 — — Article 32(1) — — Article 36(3) — — Article 44(2) — — Article 45(3) and (4) — — Article 46(2), (3) and (4) — — Article 47(3) — — Article 48 — — Article 49 — — Article 62(2), first subparagraph, point (h) — — — Article 2(4) — — Article 3, point (a) — — Article 3, point, (h) — — Article 4(1), points (c), (e) and (f) — — Article 4(4) — — Article 6(1), points (b), (c), (d) — — Article 6(2) — — Article 7(3), (4) and (5) — — Article 9(2), point (k) — — Article 9(5), point (b) — — Article 9(6) — — Article 9(7) — — Article 9(8) — — Article 9(9) — — Article 9(10) — — Article 10(2), points (c) and (f) — — Article 10(7) — — Article 11 — — Article 12(3) — — Article 16(4) — — Article 20(2) — — Article 20(6) — — Article 20(8) — — Article 20(9) — — Article 23 — — Article 24 —

European Border and Coast Guard European Border and Coast Guard SUMMARY OF: Regulation (EU) 2019/1896 on the European Border and Coast Guard WHAT IS THE AIM OF THE REGULATION? It establishes a European Border and Coast Guard agency to: assure European integrated management at the EU’s border; manage border crossing efficiently; and make the EU’s return* policy more effective as a key component of sustainable migration management. It aims to address migratory challenges and potential future threats at the borders, combat serious international crime, and ensure internal EU security while fully respecting fundamental rights and safeguarding free movement. KEY POINTS A standing corps of 10,000 border guards: will ensure that the agency can support EU Member States whenever and wherever needed; will bring together agency staff, as well as border guards and return experts seconded or deployed by Member States, who will support the over 100,000 national border guards in their tasks. In addition, the agency will have a budget to acquire its own equipment, such as vessels, planes and vehicles. Executive powers The standing corps will be able to carry out border control and return tasks, such as identity checks, authorising entry at the external borders, and carrying out border surveillance — only with the agreement of the host Member State. More support on return In addition to organising and financing joint return operations, the agency will now also be able to support Member States at all stages of return process with Member States remaining responsible for taking return decisions. This support can now also include, for example, providing assistance to returnees before, during and post-arrival, as well as identifying non-EU nationals with no right to stay or acquiring travel documents. Stronger cooperation with non-EU countries The agency will be able — subject to prior agreement of the country concerned — to launch joint operations and deploy staff outside the EU, beyond countries neighbouring the EU, to provide support on border management. Antenna offices The agency will be able to set up antenna offices in Member States and in a non-EU country (subject to a status agreement) to support logistically its operational activities and guarantee the smooth running of operations. European Border Surveillance System (Eurosur) To improve Eurosur’s operation, the regulation incorporates it in the functioning of the European Border and Coast Guard. The regulation enlarges Eurosur’s scope to cover most of the components of European integrated border management. This means being able to better detect, anticipate and react to crisis situations at the EU’s external borders and in non-EU countries. A European Commission implementing act, Implementing Regulation (EU) 2021/581 sets out the rules concerning information exchange and cooperation for the purposes of Eurosur including situational awareness, risk analysis and for supporting the planning and conduct of border control operations. It lays down: the rules for reporting in Eurosur, including the type of information to be provided and the time limits for reporting; the details of the information layers * of the situational pictures *; the procedures for establishing specific situational pictures; the responsibilities related to the reporting, to managing the situational pictures and for operating and maintaining the various technical systems and networks that support Eurosur; Eurosur’s data security and data protection rules; quality control mechanisms. Repeal It repeals Regulations (EU) No 1052/2013 on Eurosur from 4 December 2019 and (EU) 2016/1624 from 31 December 2020. FROM WHEN DOES THE REGULATION APPLY? It has applied since 4 December 2019. BACKGROUND For more information, see: European Border and Coast Guard: The Commission welcomes agreement on a standing corps of 10,000 border guards by 2027 — press release (European Commission) EU Protects: European Border and Coast Guard — YouTube (European Commission). KEY TERMS Return: the process of a non-EU national going back voluntarily or enforced to their country of origin, an agreed country of transit, or another Member State to which the person concerned voluntarily decides to return and where they will be accepted. Information layers: situational pictures (see next entry) comprise 3 information layers: an events layer (reports on events likely to have an impact on the external border); an operational layer (reports on Member States’ own assets, reports on operational plans, as well as reports on environmental information including, in particular, meteorological and oceanographic information); and an analysis layer, based on risks analysis reports. Analysis reports aim to enhance the understanding of events at the external border which can facilitate the forecasting of trends, the planning and conduct of border control operations, as well as strategic risk analysis. Situational pictures: these contain information on the situation at European borders and the pre-frontier area. MAIN DOCUMENT Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ L 295, 14.11.2019, pp. 1-131) RELATED DOCUMENTS Commission Implementing Regulation (EU) 2021/581 of 9 April 2021 on the situational pictures of the European Border Surveillance System (EUROSUR) (OJ L 124, 12.4.2021, pp. 3-39) Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, pp. 1-52) Successive amendments to Regulation (EU) 2016/399 have been incorporated into the original text. This consolidated version is of documentary value only. last update 29.05.2021

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22.11.2019 EN Official Journal of the European Union L 302/1 RULES OF PROCEDURE 9th parliamentary term July 2019 Note to the reader: In accordance with Parliament's decisions on the use of gender-neutral language in its documents, the Rules of Procedure have been adapted to take account of the guidelines on that subject approved by the High Level Group on Gender Equality and Diversity on 11 April 2018. Interpretations of the Rules (pursuant to Rule 236) are shown in italic script. CONTENTS TITLE I MEMBERS, PARLIAMENT BODIES AND POLITICAL GROUPS 11 CHAPTER 1 MEMBERS OF THE EUROPEAN PARLIAMENT 11 Rule 1 European Parliament 11 Rule 2 Independent mandate 12 Rule 3 Verification of credentials 12 Rule 4 Term of office of Members 13 Rule 5 Privileges and immunities 13 Rule 6 Waiver of immunity 14 Rule 7 Defence of privileges and immunity 14 Rule 8 Urgent action by the President to assert immunity 15 Rule 9 Procedures on immunity 15 Rule 10 Standards of conduct 16 Rule 11 Members' financial interests and Transparency register 17 Rule 12 Internal investigations conducted by the European Anti-Fraud Office (OLAF) 18 Rule 13 Observers 18 CHAPTER 2 OFFICERS OF PARLIAMENT 18 Rule 14 Provisional Chair 18 Rule 15 Nominations and general provisions 18 Rule 16 Election of President — opening address 19 Rule 17 Election of Vice-Presidents 19 Rule 18 Election of Quaestors 19 Rule 19 Term of office of Officers 19 Rule 20 Vacancies 20 Rule 21 Early termination of an office 20 CHAPTER 3 BODIES AND DUTIES 20 Rule 22 Duties of the President 20 Rule 23 Duties of the Vice-Presidents 20 Rule 24 Composition of the Bureau 21 Rule 25 Duties of the Bureau 21 Rule 26 Composition of the Conference of Presidents 22 Rule 27 Duties of the Conference of Presidents 22 Rule 28 Duties of the Quaestors 23 Rule 29 Conference of Committee Chairs 23 Rule 30 Conference of Delegation Chairs 23 Rule 31 Continuity of an office during the election period 23 Rule 32 Accountability of the Bureau and the Conference of Presidents 23 CHAPTER 4 POLITICAL GROUPS 23 Rule 33 Establishment and dissolution of political groups 23 Rule 34 Activities and legal situation of the political groups 24 Rule 35 Intergroups 25 Rule 36 Non-attached Members 25 Rule 37 Allocation of seats in the Chamber 25 TITLE II LEGISLATIVE, BUDGETARY, DISCHARGE AND OTHER PROCEDURES 26 CHAPTER 1 LEGISLATIVE PROCEDURES — GENERAL PROVISIONS 26 Rule 38 Annual programming 26 Rule 39 Respect for fundamental rights 26 Rule 40 Verification of legal basis 27 Rule 41 Delegation of legislative powers and conferral of implementing powers 27 Rule 42 Verification of financial compatibility 27 Rule 43 Examination of respect for the principles of subsidiarity and proportionality 28 Rule 44 Access to documents and provision of information to Parliament 28 Rule 45 Representation of Parliament in Council meetings 28 Rule 46 Right of Parliament to submit proposals 28 Rule 47 Requests to the Commission for submission of proposals 29 Rule 48 Consideration of legally binding acts 29 Rule 49 Acceleration of legislative procedures 30 Rule 50 Legislative procedures on initiatives originating from institutions other than the Commission or from Member States 30 CHAPTER 2 PROCEDURE IN COMMITTEE 30 Rule 51 Legislative reports 30 Rule 52 Simplified procedure 31 Rule 53 Non-legislative reports 31 Rule 54 Own-initiative reports 31 Rule 55 Drafting of reports 32 Rule 56 Opinions of committees 32 Rule 57 Associated committee procedure 33 Rule 58 Joint committee procedure 34 CHAPTER 3 ORDINARY LEGISLATIVE PROCEDURE 34 SECTION 1 — FIRST READING 34 Rule 59 Vote in Parliament — first reading 34 Rule 60 Referral back to the committee responsible 35 Rule 61 Renewed referral to Parliament 36 Rule 62 First-reading agreement 36 SECTION 2 — SECOND READING 36 Rule 63 Communication of the Council's position 36 Rule 64 Extension of time limits 36 Rule 65 Procedure in the committee responsible 37 Rule 66 Submission to Parliament 37 Rule 67 Vote in Parliament — second reading 37 Rule 68 Admissibility of amendments to the Council's position 38 Rule 69 Second-reading agreement 38 SECTION 3 — INTERINSTITUTIONAL NEGOTIATIONS DURING THE ORDINARY LEGISLATIVE PROCEDURE 39 Rule 70 General provisions 39 Rule 71 Negotiations ahead of Parliament's first reading 39 Rule 72 Negotiations ahead of Council's first reading 39 Rule 73 Negotiations ahead of Parliament's second reading 39 Rule 74 Conduct of negotiations 40 SECTION 4 — CONCILIATION AND THIRD READING 40 Rule 75 Extension of time limits 40 Rule 76 Convening of the Conciliation Committee 40 Rule 77 Delegation to the Conciliation Committee 40 Rule 78 Joint text 41 SECTION 5 — CONCLUSION OF THE PROCEDURE 41 Rule 79 Signing and publication of adopted acts 41 CHAPTER 4 PROVISIONS SPECIFIC TO THE CONSULTATION PROCEDURE 41 Rule 80 Modified proposal for a legally binding act 41 Rule 81 Commission position on amendments 42 Rule 82 Vote in Parliament 42 Rule 83 Follow-up to Parliament's position 42 Rule 84 Renewed referral to Parliament 42 CHAPTER 5 CONSTITUTIONAL MATTERS 42 Rule 85 Ordinary Treaty revision 42 Rule 86 Simplified Treaty revision 43 Rule 87 Accession treaties 43 Rule 88 Withdrawal from the Union 43 Rule 89 Breach by a Member State of fundamental principles and values 44 Rule 90 Composition of Parliament 44 Rule 91 Enhanced cooperation between Member States 44 CHAPTER 6 BUDGETARY PROCEDURES 45 Rule 92 Multiannual financial framework 45 Rule 93 Annual budgetary procedure 45 Rule 94 Parliament's position on the draft budget 45 Rule 95 Budgetary conciliation 46 Rule 96 Definitive adoption of the budget 46 Rule 97 Provisional twelfths system 46 Rule 98 Implementation of the budget 47 Rule 99 Discharge to the Commission in respect of implementation of the budget 47 Rule 100 Other discharge procedures 47 Rule 101 Interinstitutional cooperation 47 CHAPTER 7 INTERNAL BUDGETARY PROCEDURES 47 Rule 102 Estimates of Parliament 47 Rule 103 Procedure to be applied when drawing up Parliament's estimates 48 Rule 104 Power to incur and settle expenditure, to approve accounts and to grant discharge 48 CHAPTER 8 CONSENT PROCEDURE 48 Rule 105 Consent procedure 48 CHAPTER 9 OTHER PROCEDURES 49 Rule 106 Procedure for delivering opinions on derogations to the adoption of the euro 49 Rule 107 Procedures relating to dialogue between management and labour 49 Rule 108 Procedures for scrutiny of envisaged voluntary agreements 49 Rule 109 Codification 50 Rule 110 Recasting 50 CHAPTER 10 DELEGATED AND IMPLEMENTING ACTS 51 Rule 111 Delegated acts 51 Rule 112 Implementing acts and measures 52 Rule 113 Consideration under the associated committee procedure or the joint committee procedure 53 TITLE III EXTERNAL RELATIONS 53 CHAPTER 1 INTERNATIONAL AGREEMENTS 53 Rule 114 International agreements 53 Rule 115 Provisional application or suspension of the application of international agreements or establishment of the Union's position in a body set up by an international agreement 54 CHAPTER 2 EXTERNAL REPRESENTATION OF THE UNION AND THE COMMON FOREIGN AND SECURITY POLICY 55 Rule 116 Special representatives 55 Rule 117 International representation 55 CHAPTER 3 RECOMMENDATIONS ON THE UNION'S EXTERNAL ACTION 55 Rule 118 Recommendations on the Union's external policies 55 Rule 119 Consultation of, and provision of information to, Parliament within the framework of the common foreign and security policy 56 Rule 120 Breach of human rights 56 TITLE IV TRANSPARENCY OF BUSINESS 56 Rule 121 Transparency of Parliament's activities 56 Rule 122 Public access to documents 56 Rule 123 Access to Parliament 57 TITLE V RELATIONS WITH OTHER INSTITUTIONS AND BODIES 58 CHAPTER 1 APPOINTMENTS 58 Rule 124 Election of the President of the Commission 58 Rule 125 Election of the Commission 58 Rule 126 Multiannual programming 59 Rule 127 Motion of censure on the Commission 59 Rule 128 Nomination of Judges and Advocates-General at the Court of Justice of the European Union 60 Rule 129 Appointment of the Members of the Court of Auditors 60 Rule 130 Appointment of the Members of the Executive Board of the European Central Bank 60 Rule 131 Appointments to the economic governance bodies 60 CHAPTER 2 STATEMENTS 61 Rule 132 Statements by the Commission, Council and European Council 61 Rule 133 Statements explaining Commission decisions 61 Rule 134 Statements by the Court of Auditors 62 Rule 135 Statements by the European Central Bank 62 CHAPTER 3 PARLIAMENTARY QUESTIONS 62 Rule 136 Questions for oral answer with debate 62 Rule 137 Question Time 63 Rule 138 Questions for written answer 63 Rule 139 Major interpellations for written answer 64 Rule 140 Questions for written answer to the European Central Bank 64 Rule 141 Questions for written answer concerning the Single Supervisory Mechanism and the Single Resolution Mechanism 64 CHAPTER 4 REPORTS OF OTHER INSTITUTIONS AND BODIES 65 Rule 142 Annual and other reports of other institutions or bodies 65 CHAPTER 5 RESOLUTIONS AND RECOMMENDATIONS 65 Rule 143 Motions for resolutions 65 Rule 144 Debates on cases of breaches of human rights, democracy and the rule of law 66 CHAPTER 6 CONSULTATION OF OTHER INSTITUTIONS AND BODIES 67 Rule 145 Consultation of the European Economic and Social Committee 67 Rule 146 Consultation of the Committee of the Regions 67 Rule 147 Requests to European Agencies 67 CHAPTER 7 INTERINSTITUTIONAL AGREEMENTS 67 Rule 148 Interinstitutional agreements 67 CHAPTER 8 REFERRALS TO THE COURT OF JUSTICE OF THE EUROPEAN UNION 68 Rule 149 Proceedings before the Court of Justice of the European Union 68 TITLE VI RELATIONS WITH NATIONAL PARLIAMENTS 69 Rule 150 Exchange of information, contacts and reciprocal facilities 69 Rule 151 Conference of Parliamentary Committees for Union Affairs (COSAC) 69 Rule 152 Conferences of parliaments 69 TITLE VII SESSIONS 70 CHAPTER 1 SESSIONS OF PARLIAMENT 70 Rule 153 Parliamentary term, sessions, part-sessions, sittings 70 Rule 154 Convening of Parliament 70 Rule 155 Venue of sittings and meetings 70 Rule 156 Attendance of Members at sittings 70 CHAPTER 2 ORDER OF BUSINESS OF PARLIAMENT 71 Rule 157 Draft agenda 71 Rule 158 Adopting and amending the agenda 71 Rule 159 Procedure in plenary without amendment and debate 71 Rule 160 Short presentation 72 Rule 161 Extraordinary debate 72 Rule 162 Topical debate requested by a political group 72 Rule 163 Urgent procedure 73 Rule 164 Joint debate 73 Rule 165 Time limits 73 CHAPTER 3 GENERAL RULES FOR THE CONDUCT OF SITTINGS 73 Rule 166 Access to the Chamber 73 Rule 167 Languages 73 Rule 168 Transitional arrangement 74 Rule 169 Distribution of documents 74 Rule 170 Electronic handling of documents 74 Rule 171 Allocation of speaking time and list of speakers 74 Rule 172 One-minute speeches 75 Rule 173 Personal statements 76 Rule 174 Prevention of obstruction 76 CHAPTER 4 MEASURES TO BE TAKEN IN THE EVENT OF NON-COMPLIANCE WITH THE STANDARDS OF CONDUCT OF MEMBERS 76 Rule 175 Immediate measures 76 Rule 176 Penalties 77 Rule 177 Internal appeal procedures 78 CHAPTER 5 QUORUM, AMENDMENTS AND VOTING 78 Rule 178 Quorum 78 Rule 179 Thresholds 78 Rule 180 Tabling and presenting amendments 79 Rule 181 Admissibility of amendments 80 Rule 182 Voting procedure 81 Rule 183 Order of voting on amendments 81 Rule 184 Committee filter of plenary amendments 82 Rule 185 Split voting 82 Rule 186 Right to vote 82 Rule 187 Voting 82 Rule 188 Final vote 83 Rule 189 Tied votes 83 Rule 190 Voting by roll call 83 Rule 191 Voting by secret ballot 84 Rule 192 Use of electronic voting system 84 Rule 193 Disputes on voting 84 Rule 194 Explanations of votes 84 CHAPTER 6 POINTS OF ORDER AND PROCEDURAL MOTIONS 85 Rule 195 Points of order 85 Rule 196 Procedural motions 85 Rule 197 Motions calling for a matter to be declared inadmissible 86 Rule 198 Referral back to committee 86 Rule 199 Closure of a debate 86 Rule 200 Adjournment of a debate or vote 86 Rule 201 Suspension or closure of the sitting 87 CHAPTER 7 PUBLIC RECORD OF PROCEEDINGS 87 Rule 202 Minutes 87 Rule 203 Texts adopted 87 Rule 204 Verbatim reports 88 Rule 205 Audiovisual record of proceedings 88 TITLE VIII COMMITTEES AND DELEGATIONS 88 CHAPTER 1 COMMITTEES 88 Rule 206 Setting-up of standing committees 88 Rule 207 Special committees 88 Rule 208 Committees of inquiry 89 Rule 209 Composition of committees 90 Rule 210 Duties of committees 91 Rule 211 Questions of competence 91 Rule 212 Subcommittees 91 Rule 213 Committee bureaux 91 Rule 214 Committee coordinators 92 Rule 215 Shadow Rapporteurs 92 Rule 216 Committee meetings 92 Rule 217 Minutes of committee meetings 93 Rule 218 Voting in committee 93 Rule 219 Provisions concerning plenary sittings applicable in committee 93 Rule 220 Question Time in committee 93 Rule 221 Procedure for the consultation by a committee of confidential information in a committee meeting in camera 94 Rule 222 Public hearings and debates on citizens' initiatives 94 CHAPTER 2 INTERPARLIAMENTARY DELEGATIONS 95 Rule 223 Setting-up and duties of interparliamentary delegations 95 Rule 224 Joint parliamentary committees 96 Rule 225 Cooperation with the Parliamentary Assembly of the Council of Europe 96 TITLE IX PETITIONS 96 Rule 226 Right of petition 96 Rule 227 Examination of petitions 98 Rule 228 Fact-finding visits 98 Rule 229 Notice of petitions 99 Rule 230 Citizens' initiative 99 TITLE X OMBUDSMAN 99 Rule 231 Election of the Ombudsman 99 Rule 232 Activities of the Ombudsman 100 Rule 233 Dismissal of the Ombudsman 100 TITLE XI PARLIAMENT'S SECRETARIAT 101 Rule 234 Parliament's Secretariat 101 TITLE XII POWERS AND RESPONSIBILITIES RELATING TO EUROPEAN POLITICAL PARTIES AND EUROPEAN POLITICAL FOUNDATIONS 101 Rule 235 Powers and responsibilities relating to European political parties and European political foundations 101 TITLE XIII APPLICATION AND AMENDMENT OF THE RULES OF PROCEDURE 102 Rule 236 Application of the Rules of Procedure 102 Rule 237 Amendment of the Rules of Procedure 103 TITLE XIV MISCELLANEOUS PROVISIONS 103 Rule 238 The symbols of the Union 103 Rule 239 Gender Mainstreaming 103 Rule 240 Unfinished business 103 Rule 241 Corrigenda 104 ANNEX I CODE OF CONDUCT FOR MEMBERS OF THE EUROPEAN PARLIAMENT WITH RESPECT TO FINANCIAL INTERESTS AND CONFLICTS OF INTEREST 105 ANNEX II CODE OF APPROPRIATE BEHAVIOUR FOR MEMBERS OF THE EUROPEAN PARLIAMENT IN EXERCISING THEIR DUTIES 109 ANNEX III CRITERIA FOR QUESTIONS FOR WRITTEN ANSWER UNDER RULES 138, 140 AND 141 110 ANNEX IV GUIDELINES AND GENERAL PRINCIPLES TO BE FOLLOWED WHEN CHOOSING THE SUBJECTS TO BE INCLUDED ON THE AGENDA FOR THE DEBATE ON CASES OF BREACHES OF HUMAN RIGHTS, DEMOCRACY AND THE RULE OF LAW PROVIDED FOR UNDER RULE 144 111 ANNEX V PROCEDURE FOR THE CONSIDERATION AND ADOPTION OF DECISIONS ON THE GRANTING OF DISCHARGE 112 ANNEX VI POWERS AND RESPONSIBILITIES OF STANDING COMMITTEES 115 ANNEX VII APPROVAL OF THE COMMISSION AND MONITORING OF COMMITMENTS MADE DURING THE HEARINGS 124 ANNEX VIII REQUIREMENTS FOR THE DRAFTING OF ACTS ADOPTED IN ACCORDANCE WITH THE ORDINARY LEGISLATIVE PROCEDURE 128 TITLE I MEMBERS, PARLIAMENT BODIES AND POLITICAL GROUPS CHAPTER 1 Members of the European Parliament Rule 1 European Parliament 1. The European Parliament is the assembly elected pursuant to the Treaties, the Act of 20 September 1976 concerning the election of the members of the European Parliament by direct universal suffrage and national legislation deriving from the Treaties. 2. Persons elected to the European Parliament shall be referred to as: ‘Членове на Европейския парламент’ in Bulgarian, ‘Diputados al Parlamento Europeo’ in Spanish, ‘Poslanci Evropského parlamentu’ in Czech, ‘Medlemmer af Europa-Parlamentet’ in Danish, ‘Mitglieder des Europäischen Parlaments’ in German, ‘Euroopa Parlamendi liikmed’ in Estonian, ‘Βoυλευτές τoυ Ευρωπαϊκoύ Κoιvoβoυλίoυ’ in Greek, ‘Members of the European Parliament’ in English, ‘Députés au Parlement européen’ in French, ‘Feisirí de Pharlaimint na hEorpa’ in Irish, ‘Zastupnici u Europskom parlamentu’ in Croatian, ‘Deputati al Parlamento europeo’ in Italian, ‘Eiropas Parlamenta deputāti’ in Latvian, ‘Europos Parlamento nariai’ in Lithuanian, ‘Európai Parlamenti Képviselők’ in Hungarian, ‘Membri tal-Parlament Ewropew’ in Maltese, ‘Leden van het Europees Parlement’ in Dutch, ‘Posłowie do Parlamentu Europejskiego’ in Polish, ‘Deputados ao Parlamento Europeu’ in Portuguese, ‘Deputaţi în Parlamentul European’ in Romanian, ‘Poslanci Európskeho parlamentu’ in Slovak, ‘Poslanci Evropskega parlamenta’ in Slovenian, ‘Euroopan parlamentin jäsenet’ in Finnish, ‘Ledamöter av Europaparlamentet’ in Swedish. Rule 2 Independent mandate In accordance with Article 6(1) of the Act of 20 September 1976 and with Article 2(1) and Article 3(1) of the Statute for Members of the European Parliament, Members shall exercise their mandate freely and independently, shall not be bound by any instructions and shall not receive a binding mandate. Rule 3 Verification of credentials 1. Following general elections to the European Parliament, the President shall invite the competent authorities of the Member States to notify Parliament without delay of the names of the elected Members so that all Members may take their seats in Parliament with effect from the opening of the first sitting following the elections. At the same time, the President shall draw the attention of those authorities to the relevant provisions of the Act of 20 September 1976 and invite them to take the necessary measures to avoid any incompatibility with the office of Member of the European Parliament. 2. Members whose election has been notified to Parliament shall declare in writing, before taking their seat in Parliament, that they do not hold any office incompatible with that of Member of the European Parliament within the meaning of Article 7(1) or (2) of the Act of 20 September 1976. Following general elections, the declaration shall be made, where possible, no later than six days prior to Parliament's first sitting following the elections. Until such time as Members' credentials have been verified or a ruling has been given on any dispute, and provided that they have previously signed the above-mentioned written declaration, they shall take their seat in Parliament and on its bodies and shall enjoy all the rights attaching thereto. Where it is established from facts verifiable from sources available to the public that a Member holds an office incompatible with that of Member of the European Parliament, within the meaning of Article 7(1) or (2) of the Act of 20 September 1976, Parliament, on the basis of the information provided by its President, shall establish that there is a vacancy. 3. On the basis of a report by the committee responsible, Parliament shall verify credentials without delay and rule on the validity of the mandate of each of its newly elected Members and also on any disputes referred to it pursuant to the provisions of the Act of 20 September 1976, other than those which, under that Act, fall exclusively under the national provisions to which that Act refers. The committee's report shall be based on the official notification by each Member State of the full results of the election, specifying the names of the candidates elected and those of any substitutes, together with their ranking in accordance with the results of the vote. The validity of the mandate of a Member may not be confirmed unless the written declarations required under this Rule and Annex I to these Rules of Procedure have been made. 4. On the basis of a proposal by the committee responsible, Parliament shall, without delay, verify the credentials of individual Members who are replacing outgoing Members and may at any time rule on any dispute as to the validity of the mandate of any of its Members. 5. Where the appointment of a Member is due to the withdrawal of candidates from the same list, the committee responsible shall ensure that the withdrawal in question has taken place in accordance with the spirit and the letter of the Act of 20 September 1976 and Rule 4(2). 6. The committee responsible shall ensure that any information which may affect the eligibility of the Member or the eligibility or the ranking of the substitutes is forwarded to Parliament without delay by the authorities of the Member States or of the Union, with, in the case of an appointment, an indication of the date on which it will take effect. Should the competent authorities of the Member States initiate a procedure which might lead to the disqualification of a Member from holding office, the President shall ask them to keep him or her regularly informed of the stage reached in the procedure and shall refer the matter to the committee responsible. On a proposal from that committee, Parliament may adopt a position on the matter. Rule 4 Term of office of Members 1. A Member's term of office begins and ends as laid down in Articles 5 and 13 of the Act of 20 September 1976. 2. Members who resign shall notify the President of their resignation and of the date on which that resignation is to take effect, which may not be more than three months after notification. This notification shall take the form of an official record drawn up in the presence of the Secretary-General or his or her representative, signed by the latter and by the Member concerned and immediately submitted to the committee responsible, which shall enter it on the agenda of its first meeting following receipt of the document. If the committee responsible considers that the resignation is in compliance with the Act of 20 September 1976, a vacancy shall be declared with effect from the date indicated by the resigning Member in the official record, and the President shall inform Parliament thereof. If the committee responsible considers that the resignation is not in compliance with the Act of 20 September 1976, it shall propose to Parliament that it not declare a vacancy. 3. Where no meeting of the committee responsible is scheduled before the next part-session, the rapporteur of the committee responsible shall immediately examine any resignation that has been duly notified. Where delay in considering the notification would be prejudicial, the rapporteur shall refer the matter to the committee Chair, requesting, pursuant to paragraph 2, that: — the President be informed on behalf of the committee that a vacancy may be declared, or — an extraordinary meeting of the committee be convened to examine specific difficulties noted by the rapporteur. 4. Where either the competent authorities of the Member States or of the Union or the Member concerned notifies the President of an appointment or election to an office that is incompatible with the office of Member of the European Parliament within the meaning of Article 7(1) or (2) of the Act of 20 September 1976, the President shall inform Parliament thereof, and Parliament shall declare that a vacancy exists from the date of the incompatibility. Where the competent authorities of the Member States notify the President of the end of the term of office of a Member of the European Parliament as a result either of an additional incompatibility established by the law of that Member State in accordance with Article 7(3) of the Act of 20 September 1976 or of the withdrawal of the Member's mandate pursuant to Article 13(3) of that Act, the President shall inform Parliament that the term of office of that Member ended on the date communicated by competent authorities of the Member State. Where no such date is communicated, the date of the end of the term of office shall be the date of the notification by that Member State. 5. Where the authorities of the Member States or of the Union inform the President of an assignment they intend to entrust to a Member, the President shall refer to the committee responsible the question of the compatibility of the proposed assignment with the Act of 20 September 1976 and shall inform Parliament, the Member and the authorities concerned of the conclusions reached by that committee. 6. When Parliament has established a vacancy, the President shall inform the Member State concerned thereof, and invite it to fill the seat without delay. 7. Where acceptance or termination of office appears to be based on material inaccuracy or vitiated consent, Parliament may declare the appointment under consideration to be invalid or may refuse to establish the vacancy. Rule 5 Privileges and immunities 1. Members enjoy the privileges and immunities laid down in the Protocol No 7 on the Privileges and Immunities of the European Union. 2. In exercising its powers on privileges and immunities, Parliament shall act to uphold its integrity as a democratic legislative assembly and to ensure the independence of its Members in the performance of their duties. Parliamentary immunity is not a Member's personal privilege but a guarantee of the independence of Parliament as a whole, and of its Members. 3. A laissez-passer of the European Union allowing a Member to circulate freely in the Member States and in other countries which recognise it as a valid travel document shall be issued by the European Union to a Member at his or her request, on condition that the President of the Parliament gives his or her authorisation. 4. For the purpose of performing their parliamentary duties, all Members shall have the right to participate actively in the work of Parliament's committees and delegations in accordance with the provisions of these Rules of Procedure. 5. Members shall be entitled to inspect any files held by Parliament or a committee, other than personal files and accounts, which only the Members concerned shall be allowed to inspect. Exceptions to this rule, concerning the handling of documents to which public access may be denied, pursuant to Regulation (EC) No 1049/2001 of the European Parliament and of the Council (1), are laid down in Rule 221. With the approval of the Bureau, a Member may, on the basis of a reasoned decision, be denied the right to inspect a Parliament document if, after hearing the Member concerned, the Bureau comes to the conclusion that such an inspection would cause unacceptable damage to Parliament's institutional interests or to the public interest, and that the Member concerned is seeking to inspect the document for private and personal reasons. The Member may lodge a written appeal against such a decision within one month of the notification thereof. In order to be admissible, written appeals must include reasons. Parliament shall reach a decision on the appeal without debate during the part-session that follows its lodging. Access to confidential information is subject to the rules laid down in interinstitutional agreements concluded by Parliament relating to the treatment of confidential information (2) and to the internal rules for their implementation adopted by Parliament's competent bodies (3). Rule 6 Waiver of immunity 1. Any request for waiver of immunity shall be evaluated in accordance with Articles 7, 8 and 9 of the Protocol No 7 on the Privileges and Immunities of the European Union and with the principles referred to in Rule 5(2). 2. Where Members are required to appear as witnesses or expert witnesses, there is no need to request a waiver of immunity, provided: — that they will not be obliged to appear on a date or at a time which prevents them from performing their parliamentary duties, or makes it difficult for them to perform those duties, or that they will be able to provide a statement in writing or in any other form which does not make it difficult for them to perform their parliamentary duties, and — that they are not obliged to testify concerning information obtained confidentially in the performance of their parliamentary duties which they do not see fit to disclose. Rule 7 Defence of privileges and immunity 1. In cases where it is alleged that an infringement of the privileges and immunities of a Member or former Member by the authorities of a Member State has occurred or is about to occur, a request for a Parliament decision as to whether those privileges and immunities have been or are likely to be breached may be made in accordance with Rule 9(1). 2. In particular, such a request for the defence of privileges and immunities may be made if it is considered that the circumstances would constitute an administrative or other restriction on the free movement of Members travelling to or from the place of meeting of Parliament or an administrative or other restriction on an opinion expressed or a vote cast in the performance of their duties, or that the circumstances would fall within the scope of Article 9 of the Protocol No 7 on the Privileges and Immunities of the European Union. 3. A request for the defence of the privileges and immunities of a Member shall not be admissible if a request for the waiver or defence of that Member's immunity has already been received in respect of the same facts, whether or not that earlier request led to a decision. 4. No further consideration shall be given to a request for the defence of the privileges and immunities of a Member if a request for the waiver of that Member's immunity is received in respect of the same facts. 5. In cases where a decision has been taken not to defend the privileges and immunities of a Member, the Member may exceptionally make a request for reconsideration of the decision, by submitting new evidence in accordance with Rule 9(1). The request for reconsideration shall be inadmissible if proceedings have been instituted against the decision under Article 263 of the Treaty on the Functioning of the European Union, or if the President considers that the new evidence submitted is insufficiently substantiated to warrant reconsideration. Rule 8 Urgent action by the President to assert immunity 1. As a matter of urgency, in circumstances where a Member is arrested or has his or her freedom of movement curtailed in apparent breach of his or her privileges and immunities, the President may, after consulting the Chair and rapporteur of the committee responsible, take an initiative to assert the privileges and immunities of the Member concerned. The President shall notify the committee of that initiative and inform Parliament. 2. When the President makes use of the powers conferred on him or her by paragraph 1, the committee shall take cognisance of the President's initiative at its next meeting. Where the committee deems it necessary, it may prepare a report for submission to Parliament. Rule 9 Procedures on immunity 1. Any request addressed to the President by a competent authority of a Member State for the immunity of a Member to be waived, or by a Member or a former Member for privileges and immunities to be defended, shall be announced in Parliament and referred to the committee responsible. 2. With the agreement of the Member or the former Member concerned, the request may be made by another Member, who shall be permitted to represent the Member or former Member concerned at all stages of the procedure. The Member representing the Member or the former Member concerned shall not be involved in the decisions taken by the committee. 3. The committee shall consider, without delay but having regard to their relative complexity, requests for the waiver of immunity or requests for the defence of privileges and immunities. 4. The committee shall make a proposal for a reasoned decision which recommends the adoption or rejection of the request for the waiver of immunity or for the defence of privileges and immunities. Amendments shall not be admissible. If a proposal is rejected, the contrary decision shall be deemed to have been adopted. 5. The committee may ask the authority concerned to provide any information or explanation which the committee deems necessary in order for it to form an opinion on whether immunity should be waived or defended. 6. The Member concerned shall be given an opportunity to be heard and may present any documents or other written evidence deemed by that Member to be relevant. The Member concerned shall not be present during debates on the request for waiver or defence of his or her immunity, except for the hearing itself. The Chair of the committee shall invite the Member to be heard, indicating a date and time. The Member concerned may renounce the right to be heard. If the Member concerned fails to attend the hearing pursuant to that invitation, he or she shall be deemed to have renounced the right to be heard, unless he or she has asked to be excused from being heard on the date and at the time proposed, and has given his or her reasons. The Chair of the committee shall rule on whether such a request to be excused is to be accepted in view of the reasons given. The Member concerned shall not be permitted to appeal that ruling. If the Chair of the committee grants the request to be excused, he or she shall invite the Member concerned to be heard at a new date and time. If the Member concerned fails to comply with the second invitation to be heard, the procedure shall continue without the Member being heard. No further requests to be excused, or to be heard, may then be accepted. 7. Where the request seeks the waiver or the defence of immunity on several counts, each of these may be the subject of a separate decision. The committee's report may, exceptionally, propose that the waiver or the defence of immunity should apply solely to prosecution proceedings and that, until a final sentence is passed, the Member should be immune from any form of detention or remand or any other measure which prevents that Member from performing the duties proper to the mandate. 8. The committee may offer a reasoned opinion as to the competence of the authority in question and the admissibility of the request, but shall not, under any circumstances, pronounce on the guilt, or otherwise, of the Member, nor shall it pronounce on whether or not the opinions or acts attributed to the Member justify prosecution, even if the committee, in considering the request, acquires detailed knowledge of the facts of the case. 9. The committee's proposal for a decision shall be placed on the agenda of the first sitting following the day on which it was tabled. No amendments may be tabled to such a proposal. Discussion shall be confined to the reasons for and against each proposal to waive or uphold immunity, or to defend a privilege or immunity. Without prejudice to Rule 173, the Member whose privileges or immunities are under consideration shall not speak in the debate. The proposal or proposals for a decision contained in the report shall be put to the vote at the first voting time following the debate. After Parliament has considered the matter, a separate vote shall be taken on each of the proposals contained in the report. If a proposal is rejected, the contrary decision shall be deemed to have been adopted. 10. The President shall immediately communicate Parliament's decision to the Member concerned and to the competent authority of the Member State concerned, with a request that the President be informed of any developments and judicial rulings in the relevant proceedings. When the President receives this information, he or she shall transmit it to Parliament in the way he or she considers most appropriate, if necessary after consulting the committee responsible. 11. The committee shall treat these matters, and handle any documents received with the utmost confidentiality. The committee shall always consider requests relating to procedures on immunity in camera. 12. Parliament shall only examine requests for the waiver of a Member's immunity that have been transmitted to it by the judicial authorities or by the Permanent Representations of the Member States. 13. The committee shall lay down principles for the application of this Rule. 14. Any inquiry as to the scope of Members' privileges or immunities made by a competent authority shall be dealt with in accordance with the above rules. Rule 10 Standards of conduct 1. The conduct of Members shall be characterised by mutual respect and shall be based on the values and principles laid down in the Treaties, and particularly in the Charter of Fundamental Rights. Members shall respect Parliament's dignity and shall not harm its reputation. 2. Members shall not compromise the smooth conduct of parliamentary business and shall not compromise the maintenance of security and order on Parliament's premises or the functioning of its equipment. 3. Members shall not disrupt the good order of the Chamber and shall refrain from improper behaviour. They shall not display banners. 4. In parliamentary debates in the Chamber, Members shall not resort to offensive language. The assessment of whether the language used by a Member in a parliamentary debate is offensive or not should take into consideration, inter alia, the identifiable intentions of the speaker, the perception of the statement by the public, the extent to which it harms the dignity and reputation of Parliament, and the freedom of speech of the Member concerned. By way of example, defamatory language, ‘hate speech’ and incitement to discrimination based, in particular, on any ground referred to in Article 21 of the Charter of Fundamental Rights, would ordinarily constitute cases of ‘offensive language’ within the meaning of this Rule. 5. Members shall comply with Parliament's rules on the treatment of confidential information. 6. Members shall refrain from any type of psychological or sexual harassment and shall respect the Code of appropriate behaviour for Members of the European Parliament in exercising their duties which is attached to these Rules of Procedure as an annex (4). Members may not be elected as office-holders of Parliament or one of its bodies, be appointed as rapporteur or participate in an official delegation or interinstitutional negotiations, if they have not signed the declaration relating to that Code. 7. Where a person working for a Member, or another person for whom the Member has arranged access to Parliament's premises or equipment, fails to comply with the standards of conduct set out in this Rule, this behaviour may, where appropriate, be imputable to the Member concerned. 8. The application of this Rule shall not otherwise detract from the liveliness of parliamentary debates, nor shall it undermine Members' freedom of speech. 9. This Rule shall apply, mutatis mutandis, in Parliament's bodies, committees and delegations. Rule 11 Members' financial interests and Transparency register 1. Parliament shall lay down rules governing the transparency of its Members' financial interests in the form of a Code of Conduct which shall be adopted by a majority of its component Members and attached to these Rules of Procedure as an annex (5). Those rules shall not otherwise prejudice or restrict Members in the exercise of their office or of any related political or other activity. 2. Members should adopt the systematic practice of only meeting interest representatives that have registered in the Transparency Register established by means of the Agreement between the European Parliament and the European Commission (6). 3. Members should publish online all scheduled meetings with interest representatives falling under the scope of the Transparency register. Without prejudice to Article 4(6) of Annex I, rapporteurs, shadow rapporteurs and committee chairs shall, for each report, publish online all scheduled meetings with interest representatives falling under the scope of the Transparency register. The Bureau shall provide for necessary infrastructure on Parliament's website. 4. The Bureau shall provide the necessary infrastructure on Members' online page on Parliament's website for those Members who wish to publish a voluntary audit or confirmation, as provided for under the applicable rules of the Statute for Members and its implementing rules, that their use of the General Expenditure Allowance complies with the applicable rules of the Statute for Members and its implementing measures. 5. These rules shall not otherwise prejudice or restrict Members in the exercise of their office or of any related political or other activity. 6. The code of conduct and the rights and privileges of former Members shall be laid down by a decision of the Bureau. No distinction shall be made in the treatment of former Members. Rule 12 Internal investigations conducted by the European Anti-Fraud Office (OLAF) The common rules laid down in the Interinstitutional Agreement concerning internal investigations by the European Anti-Fraud Office (OLAF) (7) comprising the measures that are needed to facilitate the smooth running of investigations conducted by the Office shall be applicable within Parliament, pursuant to Parliament Decision of 18 November 1999 (8). Rule 13 Observers 1. Where a Treaty on the accession of a State to the European Union has been signed, the President may, after obtaining the agreement of the Conference of Presidents, invite the parliament of the acceding State to appoint, from among its own members, a number of observers equal to the number of seats in the European Parliament to be allocated to that State upon accession. 2. Those observers shall take part in the proceedings of Parliament pending the entry into force of the Treaty of Accession, and shall have a right to speak in committees and political groups. They shall not have the right to vote or to stand for election to positions in Parliament, nor shall they represent the Parliament externally. Their participation shall not have any legal effect on Parliament's proceedings. 3. Their treatment shall be assimilated to that of a Member as regards the use of Parliament's facilities and the reimbursement of travel and subsistence expenses incurred in their activities as observers. CHAPTER 2 Officers of Parliament Rule 14 Provisional Chair (9) 1. At the sitting provided for under Rule 154(2), and at any other sitting held for the purpose of electing the President and the Bureau, the outgoing President or, failing him or her, one of the outgoing Vice-Presidents, determined in accordance with their order of precedence, or, in the absence of any of them, the Member having held office for the longest period shall take the chair until the President has been elected. 2. No business shall be transacted while a Member is provisionally in the chair by virtue of paragraph 1 unless it concerns the election of the President or the verification of credentials under the second subparagraph of Rule 3(2). Any other matter relating to the verification of credentials raised when he or she is in the chair shall be referred to the committee responsible. Rule 15 Nominations and general provisions (10) 1. The President shall be elected by secret ballot, followed by the Vice-Presidents and the Quaestors, in accordance with Rule 191. Nominations shall be with consent of the nominee, and may only be made by a political group or Members reaching at least the low threshold. New nominations may be handed in before each ballot. If the number of nominations does not exceed the number of seats to be filled, the candidates shall be elected by acclamation, unless Members or a political group or groups reaching at least the high threshold request a secret ballot. In the event of a single ballot for more than one officer, the ballot paper shall only be valid if more than half of the available votes have been cast. 2. When electing the President, Vice-Presidents and Quaestors, account should be taken of the need to ensure an overall fair representation of political views, as well as gender and geographical balance. Rule 16 Election of President — opening address (11) 1. Nominations for President shall be handed to the Member provisionally in the chair by virtue of Rule 14, who shall announce them to Parliament. If after three ballots no candidate has obtained an absolute majority of the votes cast, the fourth ballot shall, by way of derogation from Rule 15(1), be confined to the two Members who have obtained the highest number of votes in the third ballot. In the event of a tie, the older candidate shall be declared to have been elected. 2. As soon as the President has been elected, the Member who is provisionally in the chair by virtue of Rule 14 shall vacate the chair. Only the elected President may deliver an opening address. Rule 17 Election of Vice-Presidents 1. The Vice-Presidents shall then be elected on a single ballot. Those who on the first ballot, up to the number of 14, secure an absolute majority of the votes cast shall be declared to have been elected in order of the number of votes obtained. If the number of candidates elected is less than the number of seats to be filled, a second ballot shall be held under the same conditions to fill the remaining seats. If a third ballot is necessary, a relative majority shall suffice for election to the remaining seats. In the event of a tie, the oldest candidates shall be declared to have been elected. 2. Subject to the provisions of Rule 20(1), the Vice-Presidents shall take precedence in the order in which they were elected and, in the event of a tie, by age. If Vice-Presidents are elected by acclamation, a secret ballot shall be held to determine their order of precedence. Rule 18 Election of Quaestors Parliament shall elect five Quaestors by the same procedure as that used for the election of the Vice-Presidents. Rule 19 Term of office of Officers (12) 1. The term of office of the President, Vice-Presidents and Quaestors shall be two-and-a-half years. When Members change political groups they shall retain, for the remainder of their two-and-a- half-year term of office, any seat they hold in the Bureau or as Quaestors. 2. If a vacancy for one of these positions occurs before the expiry of this term of office, the Member elected shall serve only the remaining period of his or her predecessor's term of office. Rule 20 Vacancies (13) 1. If it becomes necessary for the President, a Vice-President or a Quaestor to be replaced, a successor shall be elected in accordance with the respective rules for elections to the office concerned. A newly elected Vice-President shall take the place of his or her predecessor in the order of precedence. 2. If the office of President becomes vacant, a Vice-President, determined in accordance with the order of precedence, shall act as President until a new President is elected. Rule 21 Early termination of an office The Conference of Presidents may, acting by a majority of three-fifths of the votes cast, representing at least three political groups, propose to Parliament that it bring to an end the term of office of the President, a Vice-President, a Quaestor, a Chair or Vice-Chair of a committee, a Chair or Vice-Chair of an interparliamentary delegation, or of any other office holder elected within the Parliament, where it considers that the Member in question has been guilty of serious misconduct. Parliament shall take a decision on that proposal by a majority of two-thirds of the votes cast, constituting a majority of its component Members. Where a rapporteur breaches the provisions of the Code of Conduct for Members of the European Parliament with respect to financial interests and conflicts of interest (14), the committee which appointed him or her may, at the initiative of the President and on a proposal by the Conference of Presidents, terminate the holding of that office. The majorities laid down in the first paragraph shall apply mutatis mutandis to each stage of this procedure. CHAPTER 3 Bodies and duties Rule 22 Duties of the President 1. The President shall direct all the activities of Parliament and its bodies in accordance with these Rules and shall enjoy all powers that are necessary to preside over the proceedings of Parliament and to ensure that they are properly conducted. 2. The duties of the President shall be to open, suspend and close sittings; to rule on the admissibility of amendments and other texts put to the vote, as well as on the admissibility of parliamentary questions; to ensure observance of these Rules; to maintain order; to call upon speakers; to close debates; to put matters to the vote and to announce the results of votes; as well as to refer to committees any communications that concern them. 3. The President may speak in a debate only to sum up or to call speakers to order. Should the President wish to take part in a debate, he or she shall vacate the chair and shall not reoccupy it until the debate is over. 4. Parliament shall be represented in international relations, on ceremonial occasions and in administrative, legal and financial matters by the President, who may delegate these powers. 5. The President is responsible for the security and the inviolability of the premises of the European Parliament. Rule 23 Duties of the Vice-Presidents 1. If the President is absent or unable to discharge his or her duties, or if the President wishes to take part in a debate pursuant to Rule 22(3), he or she shall be replaced by one of the Vice-Presidents determined in accordance with the order of precedence. 2. The Vice-Presidents shall also carry out the duties conferred upon them under Rules 25, 27(3) and (5), and 77(3). 3. The President may delegate any duties to the Vice-Presidents, such as representing Parliament at specific ceremonies or acts. In particular, the President may designate a Vice-President to carry out the duties of the President laid down in Rules 137 and 138(2). Rule 24 Composition of the Bureau 1. The Bureau shall consist of the President and the 14 Vice-Presidents of Parliament. 2. The Quaestors shall be members of the Bureau in an advisory capacity. 3. If voting in the Bureau results in a tie, the President shall have the casting vote. Rule 25 Duties of the Bureau 1. The Bureau shall carry out the duties assigned to it under these Rules of Procedure. 2. The Bureau shall take financial, organisational and administrative decisions on matters concerning the internal organisation of Parliament, its Secretariat and its bodies. 3. The Bureau shall take financial, organisational and administrative decisions on matters concerning Members on a proposal of the Secretary-General or of a political group. 4. The Bureau shall take decisions on matters relating to the conduct of sittings. 5. The Bureau shall adopt the provisions referred to in Rule 36 concerning non-attached Members. 6. The Bureau shall decide the establishment plan of the Parliament's Secretariat and shall lay down regulations concerning the administrative and financial situation of officials and other servants. 7. The Bureau shall draw up Parliament's preliminary draft budget estimates. 8. The Bureau shall adopt the guidelines for the Quaestors, and may request that they carry out certain tasks. 9. The Bureau shall be the authority responsible for authorising meetings or missions of committees away from the usual places of work, hearings as well as study and fact-finding journeys by rapporteurs. Where such meetings or missions are authorised, the language arrangements shall be determined on the basis of the Code of Conduct on multilingualism adopted by the Bureau. The same rule shall apply to delegations. 10. The Bureau shall appoint the Secretary-General in accordance with Rule 234. 11. The Bureau shall lay down the implementing rules relating to the regulations governing political parties and foundations at European level and the rules regarding their funding. 12. The Bureau shall lay down rules concerning the treatment of confidential information by Parliament and its bodies, office-holders and other Members, taking into account any interinstitutional agreement concluded on such matters. Those rules shall be published in the Official Journal of the European Union. 13. The President and/or the Bureau may entrust one or more members of the Bureau with general or specific tasks lying within the competence of the President and/or the Bureau. At the same time the ways and means of carrying them out shall be laid down. 14. The Bureau shall nominate two Vice-Presidents who shall be entrusted with the implementation of relations with the national parliaments. 15. The Bureau shall nominate a Vice-President who shall be entrusted with the implementation of structured consultation with European civil society on major topics. 16. The Bureau shall be responsible for the application of the Statute for Members and shall decide on the amounts of the allowances on the basis of the annual budget. Rule 26 Composition of the Conference of Presidents 1. The Conference of Presidents shall consist of the President of Parliament and the Chairs of the political groups. The Chair of a political group may arrange to be represented by a member of that group. 2. The President of Parliament shall, after giving the opportunity to non-attached Members to express their views, invite one of them to attend meetings of the Conference of Presidents, without the right to vote. 3. The Conference of Presidents shall endeavour to reach a consensus on the matters referred to it. Where a consensus cannot be reached, the matter shall be put to a vote subject to a weighting based on the number of Members in each political group. Rule 27 Duties of the Conference of Presidents 1. The Conference of Presidents shall carry out the duties assigned to it under these Rules of Procedure. 2. The Conference of Presidents shall take decisions on the organisation of Parliament's work and on matters of legislative planning. 3. The Conference of Presidents shall be the authority responsible for matters concerning Parliament's relations with the other institutions and bodies of the European Union and with the national parliaments of Member States. Decisions concerning the mandate and composition of the delegation from Parliament which is to participate in consultations within the Council and in other European Union Institutions on fundamental issues concerning the development of the European Union (Sherpa process) shall be taken on the basis of relevant positions adopted by Parliament and taking into account the diversity of political views represented within Parliament. The Vice-Presidents who have been entrusted with the implementation of Parliament's relations with the national parliaments shall regularly report back to the Conference of Presidents on their activities in that regard. 4. The Conference of Presidents shall be the authority responsible for matters concerning relations with non-member countries and with non-Union institutions and organisations. 5. The Conference of Presidents shall be responsible for organising structured consultation with European civil society on major topics. That consultation may include holding public debates on subjects of general European interest in which interested citizens may participate. The Vice-President responsible for the implementation of such consultation shall report back regularly to the Conference of Presidents on his or her activities in this regard. 6. The Conference of Presidents shall draw up the draft agenda of Parliament's part-sessions. 7. The Conference of Presidents shall make proposals to Parliament concerning the composition and competence of committees, committees of inquiry, joint parliamentary committees and standing delegations. The Conference of Presidents shall be responsible for authorising ad hoc delegations. 8. The Conference of Presidents shall decide pursuant to Rule 37 how seats in the Chamber are to be allocated. 9. The Conference of Presidents shall be the authority responsible for authorising the drawing up of own-initiative reports. 10. The Conference of Presidents shall submit to the Bureau proposals on administrative and budgetary matters concerning the political groups. Rule 28 Duties of the Quaestors The Quaestors shall be responsible for administrative and financial matters directly concerning Members, in accordance with guidelines laid down by the Bureau, as well as for other tasks entrusted to them. Rule 29 Conference of Committee Chairs 1. The Conference of Committee Chairs shall consist of the Chairs of all standing or special committees. It shall elect its chair. 2. In the absence of the Chair, the meeting of the Conference shall be chaired by the oldest Member present. 3. The Conference of Committee Chairs may make recommendations to the Conference of Presidents about the work of committees and the drafting of the agendas of part-sessions. 4. The Bureau and the Conference of Presidents may instruct the Conference of Committee Chairs to carry out specific tasks. Rule 30 Conference of Delegation Chairs 1. The Conference of Delegation Chairs shall consist of the Chairs of all standing interparliamentary delegations. It shall elect its chair. 2. In the absence of the Chair, the meeting of the Conference shall be chaired by the oldest Member present. 3. The Conference of Delegation Chairs may make recommendations to the Conference of Presidents about the work of the delegations. 4. The Bureau and the Conference of Presidents may instruct the Conference of Delegation Chairs to carry out specific tasks. Rule 31 Continuity of an office during the election period When a new Parliament is elected, all bodies and office holders of the outgoing Parliament shall continue to be in office until the first sitting of the new Parliament. Rule 32 Accountability of the Bureau and the Conference of Presidents 1. The minutes of the Bureau and the Conference of Presidents shall be translated into the official languages and distributed to all Members of Parliament. They shall be accessible to the public, unless the Bureau or the Conference of Presidents exceptionally, for reasons of confidentiality, subject to Article 4(1) to (4) of Regulation (EC) No 1049/2001, decides otherwise with regard to certain items of the minutes. 2. Any Member of Parliament may ask questions concerning the performance by the Bureau, the Conference of Presidents and the Quaestors of their respective duties. Such questions shall be submitted to the President in writing, notified to Members and published on Parliament's website within 30 days of tabling, together with the answers given. CHAPTER 4 Political groups Rule 33 Establishment and dissolution of political groups 1. Members may form themselves into groups according to their political affinities. Parliament need not normally evaluate the political affinity of members of a group. In forming a group together under this Rule, the Members concerned accept by definition that they have political affinity. Only when this is denied by the Members concerned is it necessary for Parliament to evaluate whether the group has been constituted in accordance with the Rules. 2. A political group shall consist of Members elected in at least one-quarter of the Member States. The minimum number of Members required to form a political group shall be 25. 3. If a group falls below one of the required thresholds, the President, with the agreement of the Conference of Presidents, may allow it to continue to exist until Parliament's next constitutive sitting, provided the following conditions are met: — the members continue to represent at least one-fifth of the Member States; — the group has been in existence for a period that is longer than a year. The President shall not apply this derogation where there is sufficient evidence to suspect that it is being abused. 4. A Member may not belong to more than one political group. 5. The President shall be notified in a statement when a political group is set up. That statement shall specify: — the name of the group, — a political declaration, setting out the purpose of the group, and The political declaration of a group shall set out the values that the group stands for and the main political objectives which its members intend to pursue together in the framework of the exercise of their mandate. The declaration shall describe the common political orientation of the group in a substantial, distinctive and genuine way. — the names of its members and bureau members. All members of the group shall declare in writing in an annex to the statement that they share the same political affinity. 6. The statement shall be annexed to the minutes of the part-session during which the announcement of the establishment of the political group is made. 7. The President shall announce the establishment of political groups in Parliament. Such announcement shall have retroactive legal effect from the moment when the group notified its establishment to the President in accordance with this Rule. The President shall also announce the dissolution of political groups in Parliament. Such an announcement will take legal effect on the day following that on which the political group no longer met the conditions for existence. Rule 34 Activities and legal situation of the political groups 1. The political groups shall carry out their duties as part of the activities of the Union, including the tasks allocated to them by these Rules of Procedure. The political groups shall be provided with a secretariat on the basis of the establishment plan of the Parliament's Secretariat, with administrative facilities and with the appropriations entered for that purpose in Parliament's budget. 2. At the beginning of each parliamentary term, the Conference of Presidents shall endeavour to agree procedures for reflecting the political diversity of Parliament in the committees and delegations, as well as in the decision-making bodies. 3. The Bureau shall, having regard to any proposal made by the Conference of Presidents, lay down the rules relating to the provision, implementation and monitoring of the facilities and appropriations referred to in paragraph 1, as well as to the related delegations of budget implementation powers and the consequences of any failure to respect those rules. 4. Those rules shall determine the administrative and financial consequences in the event of the dissolution of a political group. Rule 35 Intergroups 1. Individual Members may form Intergroups or other unofficial groupings of Members, for the purpose of holding informal exchanges of views on specific issues across different political groups, drawing on members of different parliamentary committees, and of promoting contact between Members and civil society. 2. Intergroups as well as other unofficial groupings shall be fully transparent in their actions and shall not engage in any activities which might result in confusion with the official activities of Parliament or of its bodies. They may not organise events in third countries that coincide with a mission of an official Parliament body, including an official election observation delegation. 3. Provided that the conditions laid down in Parliament's internal rules governing the establishment of such groupings are complied with, a political group may facilitate their activities by providing them with logistical support. 4. Intergroups shall be required to make an annual declaration of any support, whether in cash or in kind (e.g. secretarial assistance), which, if offered to Members as individuals, would have had to be declared under Annex I. Other unofficial groupings shall also be required to declare, by the end of the following month, any support, whether in cash or in kind, which Members have not declared individually in accordance with their obligations under Annex I. 5. Only interest representatives who are registered in the Transparency register may participate in intergroup or other unofficial grouping activities organised on Parliament's premises, for instance by attending meetings or events of the intergroup or other unofficial grouping, by offering support to it, or by co-hosting its events. 6. The Quaestors shall keep a register of the declarations referred to in paragraph 4. The Quaestors shall adopt detailed rules on those declarations and their publication on Parliament's website. 7. The Quaestors shall ensure the effective enforcement of this Rule. Rule 36 Non-attached Members 1. Members who do not belong to a political group shall be provided with a secretariat. The detailed arrangements concerning such provision of secretariats shall be laid down by the Bureau on a proposal from the Secretary-General. 2. The Bureau shall determine the status and parliamentary rights of non-attached Members. 3. The Bureau shall lay down the rules relating to the provision, implementation and auditing of appropriations entered in Parliament's budget to cover the secretarial expenses and administrative facilities for non-attached Members. Rule 37 Allocation of seats in the Chamber The Conference of Presidents shall decide how seats in the Chamber are to be allocated to the political groups, the non-attached Members and the institutions of the Union. TITLE II LEGISLATIVE, BUDGETARY, DISCHARGE AND OTHER PROCEDURES CHAPTER 1 Legislative procedures — general provisions Rule 38 Annual programming 1. Parliament shall work together with the Commission and the Council to determine the legislative planning of the Union. Parliament and the Commission shall cooperate in preparing the Commission Work Programme — which is the Commission's contribution to the Union's annual and multiannual programming — in accordance with the timetable and arrangements agreed between the two institutions (15). 2. After the adoption of the Commission Work Programme, the Parliament, the Council and the Commission will, pursuant to paragraph 7 of the Interinstitutional Agreement on Better Law-Making (16), exchange views and agree on a joint declaration on annual interinstitutional programming that sets out broad objectives and priorities. Before negotiating with the Council and the Commission on the joint declaration, the President shall hold an exchange of views with the Conference of Presidents and the Conference of Committee Chairs regarding Parliament's broad objectives and priorities. Before signing the joint declaration, the President shall seek the approval of the Conference of Presidents. 3. The President shall forward any resolution adopted by Parliament concerning legislative planning and priorities to the other institutions which participate in the Union's legislative procedure and to the parliaments of the Member States. 4. If the Commission intends to withdraw a proposal, the relevant Commissioner shall be invited by the committee responsible to a meeting to discuss that intention. The Presidency of the Council may also be invited to that meeting. If the committee responsible disagrees with the intended withdrawal, it may request that the Commission make a statement to Parliament. Rule 132 shall apply. Rule 39 Respect for fundamental rights 1. In all of its activities, Parliament shall fully respect the rights, freedoms and principles recognised by Article 6 of the Treaty on European Union, and the values enshrined in Article 2 thereof. 2. Where the committee responsible for the subject matter, a political group or Members reaching at least the low threshold are of the opinion that a proposal for a legislative act, in whole or in part, does not comply with the fundamental rights of the European Union, the matter shall, at their request, be referred to the committee responsible for the protection of fundamental rights. 3. That request shall be submitted within four working weeks of the announcement in Parliament of the referral to the committee responsible for the subject matter. 4. The opinion of the committee responsible for the protection of fundamental rights shall be annexed to the report of the committee responsible for the subject-matter. Rule 40 Verification of legal basis 1. When a proposal for a legally binding act is referred to the committee responsible for the subject-matter, that committee shall first verify its legal basis. 2. If that committee disputes the validity or the appropriateness of the legal basis, including in the context of the verification of compliance with Article 5 of the Treaty on European Union, it shall request the opinion of the committee responsible for legal affairs. 3. In addition, the committee responsible for legal affairs may, on its own initiative, take up at any stage of the legislative procedure questions concerning the legal basis. In such cases it shall duly inform the committee responsible for the subject-matter. 4. If, where appropriate after the exchange of views with the Council and the Commission in accordance with the arrangements agreed at interinstitutional level (17), the committee responsible for legal affairs decides to dispute the validity or the appropriateness of the legal basis, it shall report its conclusions to Parliament. Without prejudice to Rule 61, Parliament shall vote on this before voting on the substance of the proposal. 5. If the committee responsible for the subject-matter or the committee responsible for legal affairs have not disputed the validity or appropriateness of the legal basis, amendments tabled in Parliament to change the legal basis shall be inadmissible. Rule 41 Delegation of legislative powers and conferral of implementing powers 1. When scrutinising a proposal for a legislative act which delegates powers to the Commission as provided for in Article 290 of the Treaty on the Functioning of the European Union, Parliament shall pay particular attention to the objectives, content, scope and duration of the delegation, and to the conditions to which it is subject. 2. When scrutinising a proposal for a legislative act which confers implementing powers pursuant to Article 291 of the Treaty on the Functioning of the European Union, Parliament shall pay particular attention to the fact that, in exercising an implementing power, the Commission may neither amend nor supplement the legislative act, even in respect of its non-essential elements. 3. The committee responsible for the subject-matter may at any time request the opinion of the committee that is responsible for the interpretation and application of Union law. 4. In addition, the committee responsible for the interpretation and application of Union law may, on its own initiative, take up questions concerning the delegation of legislative powers and the conferral of implementing powers. In such cases, it shall duly inform the committee responsible for the subject-matter. Rule 42 Verification of financial compatibility 1. Where a proposal for a legally binding act has financial implications, Parliament shall establish whether sufficient financial resources are provided. 2. The committee responsible for the subject-matter shall check that any proposal for a legally binding act is financially compatible with the multiannual financial framework regulation. 3. When the committee responsible for the subject-matter amends the financial endowment of the act it is considering, it shall request the opinion of the committee responsible for budgetary issues. 4. In addition, the committee responsible for budgetary issues may, on its own initiative, take up questions concerning the financial compatibility of proposals for legally binding acts. In such cases, it shall duly inform the committee responsible for the subject-matter. 5. If the committee responsible for budgetary issues decides to dispute the financial compatibility of the proposal, it shall report its conclusions to Parliament before Parliament votes on the proposal. Rule 43 Examination of respect for the principles of subsidiarity and proportionality 1. During the examination of a proposal for a legislative act, Parliament shall pay particular attention to whether that proposal respects the principles of subsidiarity and proportionality. 2. Only the committee responsible for respect for the principle of subsidiarity may make recommendations, for the attention of the committee responsible for the subject-matter, in respect of a proposal for a legislative act. 3. Except in the cases of urgency referred to in Article 4 of Protocol No 1 on the role of national parliaments in the European Union, the committee responsible for the subject-matter shall not proceed to its final vote before the expiry of the deadline of eight weeks laid down in Article 6 of Protocol No 2 on the application of the principles of subsidiarity and proportionality. 4. If a national parliament sends the President a reasoned opinion in accordance with Article 3 of Protocol No 1, that document shall be referred to the committee responsible for the subject-matter and forwarded, for information, to the committee responsible for respect for the principle of subsidiarity. 5. Where reasoned opinions on the non-compliance of a proposal for a legislative act with the principle of subsidiarity represent at least one third of all the votes allocated to the national parliaments in accordance with the second subparagraph of Article 7(1) of Protocol No 2, or a quarter in the case of a proposal for a legislative act submitted on the basis of Article 76 of the Treaty on the Functioning of the European Union, Parliament shall not take a decision until the author of the proposal has stated how it intends to proceed. 6. Where, under the ordinary legislative procedure, reasoned opinions on the non-compliance of a proposal for a legislative act with the principle of subsidiarity represent at least a simple majority of the votes allocated to the national parliaments in accordance with the second subparagraph of Article 7(1) of Protocol No 2, the committee responsible for the subject-matter, having considered the reasoned opinions submitted by the national parliaments and the Commission, and having heard the views of the committee responsible for respect for the principle of subsidiarity, may recommend to Parliament that it reject the proposal on the grounds of infringement of the principle of subsidiarity or submit to Parliament any other recommendation, which may include suggestions for amendments related to respect of the principle of subsidiarity. The opinion given by the committee responsible for respect for the principle of subsidiarity shall be annexed to any such recommendation. The recommendation shall be submitted to Parliament for debate and a vote. If a recommendation to reject the proposal is adopted by a majority of the votes cast, the President shall declare the procedure to be closed. Where Parliament does not reject the proposal, the procedure shall continue, taking into account any recommendations approved by Parliament. Rule 44 Access to documents and provision of information to Parliament 1. Throughout the legislative procedure, Parliament and its committees shall request access to all documents relating to proposals for legislative acts under the same conditions as the Council and its working parties. 2. During the examination of a proposal for a legislative act, the committee responsible shall ask the Commission and the Council to keep it informed of the progress of that proposal in the Council and its working parties, and in particular to inform it of any emerging compromises which would substantially amend the original proposal or of the author's intention to withdraw its proposal. Rule 45 Representation of Parliament in Council meetings When the Council invites Parliament to take part in a Council meeting, the President shall ask the Chair or rapporteur of the committee responsible for the subject matter, or another Member designated by that committee, to represent Parliament. Rule 46 Right of Parliament to submit proposals In cases where the Treaties confer a right of initiative on Parliament, the committee responsible may decide to draw up an own-initiative report in accordance with Rule 54. The report shall include: (a) a motion for a resolution; (b) a draft proposal; (c) an explanatory statement including, where appropriate, a financial statement. Where the adoption of an act by Parliament requires the approval or the consent of the Council and the opinion or the consent of the Commission, Parliament may, following the vote on the proposed act, and on a proposal by the rapporteur, decide to postpone the vote on the motion for a resolution until the Council or the Commission have stated their position. Rule 47 Requests to the Commission for submission of proposals 1. Parliament may request the Commission, pursuant to Article 225 of the Treaty on the Functioning of the European Union, to submit any appropriate proposal to it for the adoption of a new act or the amendment of an existing act. Parliament shall do so by adopting a resolution on the basis of an own-initiative report drawn up by the committee responsible in accordance with Rule 54. The resolution shall be adopted by a majority of the component Members of Parliament in the final vote. Parliament may, at the same time, set a deadline for the submission of such a proposal. 2. Any Member may table a proposal for a Union act on the basis of the right of initiative granted to Parliament pursuant to Article 225 of the Treaty on the Functioning of the European Union. Such a proposal may be tabled jointly by up to 10 Members. The proposal shall indicate the legal basis on which it is made and may be accompanied by an explanatory statement of no more than 150 words. The proposal shall be submitted to the President, who shall verify whether the legal requirements are fulfilled. The President may refer the proposal for an opinion on the appropriateness of the legal basis to the committee responsible for such verification. If the President declares the proposal to be admissible, he or she shall announce it in plenary and refer it to the committee responsible for the subject matter. Before such referral to the committee responsible for the subject matter, the proposal shall be translated into those official languages which the Chair of that committee considers to be necessary in order for summary consideration to be possible. The committee responsible for the subject matter shall take a decision on further action within three months of the referral, after giving the authors of the proposal the opportunity to address the committee. The authors of the proposal shall be named in the title of the report. 3. Parliament's resolution shall indicate the appropriate legal basis and shall be accompanied by recommendations concerning the content of the required proposal. 4. Where a proposal has financial implications, Parliament shall indicate how sufficient financial resources can be provided. 5. The committee responsible for the subject matter shall monitor the progress of preparation of any proposed Union legal act drawn up following a particular request by Parliament. 6. The Conference of Committee Chairs shall regularly monitor whether the Commission is complying with paragraph 10 of the Interinstitutional Agreement on Better Law-Making, according to which the Commission is to reply to requests for the submission of proposals within three months by adopting a specific communication stating the intended follow-up actions to be taken. The Conference of Committee Chairs shall regularly report on the results of such monitoring to the Conference of Presidents. Rule 48 Consideration of legally binding acts 1. The President shall refer proposals for legally binding acts received from other institutions or Member States to the committee responsible, for consideration. 2. In cases of doubt, the President may, before the announcement in Parliament of a referral to the committee responsible, submit a question concerning competence to the Conference of Presidents. The Conference of Presidents shall adopt its decision on the basis of a recommendation from the Conference of Committee Chairs, or the chair of the Conference of Committee Chairs, in accordance with Rule 211(2). 3. The committee responsible may, at any time, decide to appoint a rapporteur to follow the preparatory phase of a proposal. It shall give particular consideration to doing so where the proposal is listed in the Commission Work Programme. 4. In the event of a conflict between a provision of the Rules of Procedure relating to the second and third readings and any other provision of the Rules, the provision relating to the second and third readings shall take precedence. Rule 49 Acceleration of legislative procedures The acceleration of legislative procedures in coordination with the Council and Commission regarding specific proposals, selected in particular from among those identified as priorities in the joint declaration on annual interinstitutional programming pursuant to Rule 38(2), may be agreed by the committee or committees responsible. Rule 50 Legislative procedures on initiatives originating from institutions other than the Commission or from Member States 1. When dealing with initiatives originating from institutions other than the Commission or originating from Member States, the committee responsible may invite representatives of the institutions or those originating Member States to present their initiative to the committee. The representatives of the originating Member States may be accompanied by the Presidency of the Council. 2. Before the committee responsible proceeds to the vote, it shall ask the Commission whether it is preparing an opinion on the initiative, or if it intends to submit an alternative proposal within a short period of time. If the answer that it receives is in the affirmative, the committee shall not adopt its report before receiving that opinion or alternative proposal. 3. When two or more proposals originating from the Commission and/or another institution and/or the Member States with the same legislative objective have been submitted to Parliament simultaneously or within a short period of time, Parliament shall deal with them in a single report. In its report, the committee responsible shall indicate to which text it has proposed amendments and it shall refer to all other texts in the legislative resolution. CHAPTER 2 Procedure in committee Rule 51 Legislative reports 1. The Chair of the committee to which a proposal for a legally binding act is referred shall propose to the committee the procedure to be followed. 2. After taking a decision on the procedure to be followed, and if the simplified procedure under Rule 52 does not apply, the committee shall appoint a rapporteur on the proposal for a legally binding act from among its members or permanent substitutes if it has not yet done so on the basis of Rule 48(3). 3. The committee's report shall include: (a) amendments, if any, to the proposal, accompanied, if appropriate, by short justifications, which shall be the responsibility of the author and which shall not be put to the vote; (b) a draft legislative resolution, in accordance with Rule 59(5); (c) if appropriate, an explanatory statement including, where necessary, a financial statement which establishes the magnitude of the financial impact of the report, if any, and its compatibility with the multiannual financial framework; (d) if available, a reference to the Impact Assessment by Parliament. Rule 52 Simplified procedure 1. Following a first discussion of a proposal for a legally binding act, the Chair may propose that it be approved without amendment. Unless members or a political group or groups reaching at least the medium threshold in the committee object, the proposed procedure shall be deemed to have been approved. The Chair, or, if one has been appointed, the rapporteur, shall present to Parliament a report approving the proposal. The second subparagraph of Rule 159(1) and Rule 159(2) and (4) shall apply. 2. Alternatively, the Chair may propose that a set of amendments be drafted by the Chair or by the rapporteur reflecting the committee's discussion. Unless members or a political group or groups reaching at least the medium threshold in the committee object, the proposed procedure shall be deemed to have been approved and the amendments shall be sent to the members of the committee. Unless members or a political group or groups reaching at least the medium threshold in the committee object to the amendments within a set time limit, which shall not be less than 10 working days from the date of dispatch, the report shall be deemed to have been adopted by the committee. In this case, the draft legislative resolution and the amendments shall be submitted to Parliament without debate pursuant to the second subparagraph of Rule 159(1) and Rule 159(2) and (4). If members or a political group or groups reaching at least the medium threshold in the committee object to the amendments, they shall be put to the vote at the next meeting of the committee. 3. With the exception of the provisions concerning the submission to Parliament, this Rule shall apply mutatis mutandis to committee opinions within the meaning of Rule 56. Rule 53 Non-legislative reports 1. Where a committee draws up a non-legislative report, it shall appoint a rapporteur from among its members or permanent substitutes. 2. The committee's report shall include: (a) a motion for a resolution; (b) an explanatory statement including, where necessary, a financial statement which establishes the magnitude of the financial impact of the report, if any, and its compatibility with the multiannual financial framework; (c) the texts of any motions for resolutions to be included under Rule 143(7). Rule 54 Own-initiative reports 1. A committee intending to draw up a non-legislative report or a report under Rule 46 or 47 on a subject within its competence on which no referral has taken place, may do so only with the authorisation of the Conference of Presidents. The Conference of Presidents shall take a decision on requests for authorisation to draw up reports submitted pursuant to the first subparagraph on the basis of implementing provisions, which it shall lay down. 2. Where the Conference of Presidents decides to withhold such authorisation, it shall state its reasons for doing so. Where the subject matter of the report falls within Parliament's right of initiative referred to in Rule 46, the Conference of Presidents may only decide to withhold such authorisation if the conditions set out in the Treaties are not met. 3. In the cases referred to in Rules 46 and 47, the Conference of Presidents shall take a decision within two months. 4. Motions for resolutions submitted to Parliament shall be examined under the short presentation procedure set out in Rule 160. Amendments to such motions for resolutions and requests for split votes or separate votes shall only be admissible for consideration in plenary if they are tabled either by the rapporteur, in order to take account of new information, or by at least one-tenth of the Members. Political groups may table alternative motions for resolutions in accordance with Rule 181(3). Rule 190 shall apply to the committee's motion for a resolution and amendments thereto. Rule 190 shall also apply to the single vote on alternative motions for resolutions. 5. Paragraph 4 shall not apply where the subject of the report qualifies for a key debate in plenary, where the report is drawn up pursuant to the right of initiative referred to in Rule 46 or 47, or where the report has been authorised as a strategic report (18). Rule 55 Drafting of reports 1. The rapporteur shall be responsible for preparing the committee's report and for presenting it to Parliament on behalf of that committee. 2. The explanatory statement shall be the responsibility of the rapporteur and shall not be put to the vote. It must, however, accord with the text of the motion for a resolution as adopted and any amendments proposed by the committee. If it fails to do so, the Chair of the committee may delete the explanatory statement. 3. The report shall state the result of the vote taken on the report as a whole and shall indicate, in line with Rule 218(3), how each member voted. 4. Minority positions may be expressed when the vote on the text as a whole is taken and may, at the request of their authors, be the subject of a written declaration not exceeding 200 words in length, which shall be annexed to the explanatory statement. The Chair shall settle any disputes which may arise as a result of the application of this paragraph. 5. On a proposal from its Chair, the committee may set a deadline within which the rapporteur must submit the draft report. This deadline may be extended or a new rapporteur appointed. 6. Once the deadline has expired, the committee may instruct its Chair to ask for the matter that has been referred to it to be placed on the agenda of one of the next sittings of Parliament. The debates and votes may then be conducted on the basis of an oral report by the committee concerned. Rule 56 Opinions of committees 1. If the committee to which a matter was first referred wishes to hear the views of another committee, or if another committee wishes to make known its views to the committee to which a matter was first referred, such committees may ask the President in accordance with Rule 210(2) for one committee to be named as the committee responsible and the other as the opinion-giving committee. The opinion giving committee may appoint a rapporteur for opinion from among its members or permanent substitutes or send its views in the form of a letter from the Chair. 2. Where the opinion concerns a proposal for a legally binding act, it shall consist of amendments to the text referred to the committee, accompanied, where appropriate, by short justifications. Such justifications shall be the responsibility of their author and shall not be put to the vote. If necessary, the opinion-giving committee may submit a short written justification for the opinion as a whole. That short written justification shall be the responsibility of the rapporteur for the opinion. Where the opinion does not concern a proposal for a legally binding act, it shall consist of suggestions for parts of the motion for a resolution submitted by the committee responsible. The committee responsible shall put these amendments or suggestions to the vote. The opinions shall deal solely with those matters that fall within the areas of responsibility of the opinion-giving committee. 3. The committee responsible shall set a deadline within which the opinion-giving committee must deliver its opinion if it is to be taken into account by the committee responsible. Any changes to the announced timetable shall be immediately communicated by the committee responsible to the opinion-giving committee or opinion giving committees. The committee responsible shall not reach its final conclusions before that time-limit has expired. 4. Alternatively, the opinion-giving committee may decide to present its position in the form of amendments to be tabled directly in the committee responsible following their adoption. These amendments shall be tabled by the Chair or the rapporteur on behalf of the opinion-giving committee. 5. The opinion-giving committee shall table the amendments referred to in paragraph 4 within the deadline for amendments set by the committee responsible. 6. All opinions and amendments adopted by the opinion-giving committee shall be annexed to the report of the committee responsible. 7. Opinion-giving committees within the meaning of this Rule cannot table amendments for consideration by Parliament. 8. The Chair and rapporteur of the opinion-giving committee shall be invited to take part in an advisory capacity in meetings of the committee responsible, insofar as these relate to the matter of common concern. Rule 57 Associated committee procedure 1. Where a question of competence is referred to the Conference of Presidents pursuant to Rule 211, and the Conference of Presidents, on the basis of Annex VI, considers that the matter falls almost equally within the competence of two or more committees, or that different parts of the matter fall within the competence of two or more committees, Rule 56 shall apply with the following additional provisions: — the timetable shall be jointly agreed by the committees concerned, — the rapporteurs concerned shall keep each other informed and shall endeavour to agree on the texts they propose to their committees and on their position regarding amendments, — the Chairs and rapporteurs concerned are bound by the principle of good and sincere cooperation; they shall jointly identify areas of the text falling within their exclusive or shared competence and agree on the precise arrangements for their cooperation; in the event of disagreement about the delimitation of competences the matter shall be submitted, at the request of one of the committees involved, to the Conference of Presidents; the Conference of Presidents may decide on the question of the respective competences or decide that the joint committee procedure under Rule 58 is to apply; it shall take its decision in accordance with the procedure and within the deadline set out in Rule 211, — the committee responsible shall accept without a vote amendments from an associated committee where they concern matters which fall within the exclusive competence of that associated committee; if the committee responsible fails to respect the exclusive competence of the associated committee, that associated committee may table amendments directly in plenary; if amendments on matters which fall within the shared competence of the committee responsible and an associated committee are not adopted by the committee responsible, the associated committee may table those amendments directly in plenary, — in the event of a conciliation procedure in respect of the proposal, Parliament's delegation shall include the rapporteur of any associated committee. A decision by the Conference of Presidents to apply the associated committee procedure applies at all stages of the procedure in question. The rights attaching to the status of ‘committee responsible’ are exercised by the lead committee. In exercising those rights, the lead committee must take due account of the prerogatives of the associated committee. In particular, the lead committee must comply with the obligation to observe the principle of sincere cooperation as regards the timetable and respect the right of the associated committee to determine the amendments submitted in plenary which fall within its exclusive competence. 2. The procedure laid down in this Rule shall not apply to the recommendations to be adopted by the committee responsible under Rule 105. Rule 58 Joint committee procedure 1. When a question of competence is referred to it pursuant to Rule 211, the Conference of Presidents may decide that the procedure with joint meetings of committees and a joint vote is to be applied, provided that: — by virtue of Annex VI, the matter falls indissociably within the competences of several committees, and — it is satisfied that the question is of major importance. 2. In that event, the respective rapporteurs shall draw up a single draft report, which shall be examined and voted on by the committees involved, under the joint chairmanship of the committee Chairs. At all stages of the procedure, the rights attaching to the status of committee responsible may be exercised by the committees involved only when they are acting jointly. The committees involved may set up working groups to prepare the meetings and votes. 3. At the second-reading stage of the ordinary legislative procedure, the Council position shall be considered at a joint meeting of the committees involved, which, should no agreement be reached between their Chairs, shall be held on the Wednesday of the first week set aside for meetings of parliamentary bodies following the communication of the Council's position to Parliament. If no agreement is reached on the convening of a further meeting, any such meeting shall be convened by the Chair of the Conference of Committee Chairs. The vote on the recommendation for second reading shall be taken at a joint meeting on the basis of a joint text drafted by the respective rapporteurs of the committees involved or, in the absence of a joint text, on the basis of the amendments tabled in the committees involved. At the third-reading stage of the ordinary legislative procedure, the Chairs and rapporteurs of the committees involved shall be members ex officio of the delegation to the Conciliation Committee. CHAPTER 3 Ordinary legislative procedure SECTION 1 — FIRST READING Rule 59 Vote in Parliament — first reading 1. Parliament may approve, amend or reject the draft legislative act. 2. Parliament shall first vote on any proposal for the immediate rejection of the draft legislative act that has been tabled in writing by the committee responsible, a political group or Members reaching at least the low threshold. If that proposal for rejection is adopted, the President shall ask the originating institution to withdraw the draft legislative act. If the originating institution does so, the President shall declare the procedure closed. If the originating institution does not withdraw the draft legislative act, the President shall announce that the first reading of Parliament is concluded, unless, on a proposal of the Chair or rapporteur of the committee responsible or of a political group or Members reaching at least the low threshold, Parliament decides to refer the matter back to the committee responsible for reconsideration. If that proposal for rejection is not adopted, Parliament shall then proceed in accordance with paragraphs 3, 4 and 5. 3. Any provisional agreement tabled by the committee responsible under Rule 74(4) shall be given priority in voting and shall be put to a single vote, unless, at the request of a political group or Members reaching at least the low threshold, Parliament decides instead to proceed with the vote on amendments in accordance with paragraph 4. In that case, Parliament shall also decide whether to hold the vote on the amendments immediately. If not, Parliament shall set a new deadline for amendments and the vote shall take place at a subsequent sitting. If, in that single vote, the provisional agreement is adopted, the President shall announce that the first reading of Parliament has been concluded. If, in that single vote, the provisional agreement fails to secure the majority of the votes cast, the President shall set a new deadline for amendments to the draft legislative act. Such amendments shall then be put to the vote at a subsequent sitting in order for Parliament to conclude its first reading. 4. Save where a proposal for rejection has been adopted in accordance with paragraph 2 or a provisional agreement has been adopted in accordance with paragraph 3, any amendments to the draft legislative act shall then be put to the vote, including, where applicable, individual parts of the provisional agreement where requests have been made for split or separate votes, or competing amendments have been tabled. Before Parliament votes on the amendments, the President may ask the Commission to state its position and the Council to comment. After it has voted on those amendments, Parliament shall vote on the whole draft legislative act, amended or otherwise. If the whole draft legislative act, amended or otherwise, is adopted, the President shall announce that the first reading has been concluded, unless, on a proposal of the Chair or the rapporteur of the committee responsible or of a political group or Members reaching at least the low threshold, Parliament decides to refer the matter back to the committee responsible, for interinstitutional negotiations in accordance with Rules 60 and 74. If the whole draft legislative act, as amended or otherwise, fails to secure a majority of the votes cast, the President shall announce that the first reading has been concluded, unless, on a proposal of the Chair or rapporteur of the committee responsible or of a political group or Members reaching at least the low threshold, Parliament decides to refer the matter back to the committee responsible for reconsideration. 5. After the votes taken under paragraphs 2, 3 and 4, and the votes subsequently taken on amendments to the draft legislative resolution relating to procedural requests, if any, the legislative resolution shall be deemed to have been adopted. If necessary, the legislative resolution shall be modified pursuant to Rule 203(2), in order to reflect the outcome of the votes taken under paragraphs 2, 3 and 4. The text of the legislative resolution and of Parliament's position shall be forwarded, by the President, to the Council and the Commission, as well as, where the draft legislative act originates from them, to the originating group of Member States, the Court of Justice or the European Central Bank. Rule 60 Referral back to the committee responsible If, in accordance with Rule 59, a matter is referred back to the committee responsible for reconsideration or for interinstitutional negotiations in accordance with Rule 74, the committee responsible shall, orally or in writing, report to Parliament within four months. That period may be extended by the Conference of Presidents. Following a referral back to committee, the lead committee must, before taking a decision on the procedure to be followed, allow an associated committee, as Rule 57 provides, to make choices as to the amendments which fall within its exclusive competence, and in particular to choose which amendments are to be resubmitted in plenary. Nothing prevents Parliament from deciding to hold, if appropriate, a concluding debate following the report by the committee responsible, to which the matter was referred back. Rule 61 Renewed referral to Parliament 1. The President shall, at the request of the committee responsible, ask the Commission to refer its proposal again to Parliament where: — the Commission replaces, substantially amends or intends to substantially amend its initial proposal after Parliament has adopted its position, except where this is done in order to take account of Parliament's position, — the nature of the problem with which the proposal is concerned substantially changes as a result of the passage of time or changes in circumstances, or — new elections to Parliament have taken place since it adopted its position, and the Conference of Presidents considers it desirable. 2. If a modification of the legal basis of a proposal is envisaged which would result in the ordinary legislative procedure no longer applying to that proposal, the Parliament, Council and Commission will, pursuant to paragraph 25 of the Interinstitutional Agreement on Better Law Making, acting through their respective Presidents or their representatives, exchange views thereon. 3. Following the exchange of views referred to in paragraph 2, the President shall, at the request of the committee responsible, ask the Council to refer the draft legally binding act to Parliament again, where the Commission or the Council intends to modify the legal basis provided for in Parliament's position at first reading, with the result that the ordinary legislative procedure would no longer apply. Rule 62 First-reading agreement Where, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, the Council has informed Parliament that it has approved Parliament's position, the President, following finalisation in accordance with Rule 203, shall announce in Parliament that the legislative act has been adopted in the wording which corresponds to the position of Parliament. SECTION 2 — SECOND READING Rule 63 Communication of the Council's position 1. Communication of the Council's position pursuant to Article 294 of the Treaty on the Functioning of the European Union takes place when it is announced by the President in Parliament. The President shall make the announcement after receiving the documents which contain the position itself, all declarations made in the Council minutes when it adopted the position, the reasons which led the Council to adopt its position, and the Commission's position, duly translated into the official languages of the European Union. The President's announcement shall be made during the part-session following the receipt of those documents. Before making the announcement, the President establishes, after consulting the Chair of the committee responsible, or the rapporteur, or both of them, that the text received is indeed Council's first reading position and that the circumstances described in Rule 61 do not apply. Failing this, the President, together with the committee responsible and, where possible, in agreement with the Council, seeks an appropriate solution. 2. On the day of its announcement in Parliament, the Council's position shall be deemed to have been referred automatically to the committee responsible at first reading. 3. A list of such communications shall be published in the minutes of the sitting together with the names of the committees responsible. Rule 64 Extension of time limits 1. The President shall, at the request of the Chair of the committee responsible, extend the time-limits for second reading in accordance with Article 294(14) of the Treaty on the Functioning of the European Union. 2. The President shall notify Parliament of any extension of time limits under Article 294(14) of the Treaty on the Functioning of the European Union, whether such extensions occur at the initiative of Parliament or of the Council. Rule 65 Procedure in the committee responsible 1. The Council's position shall be entered as a priority item on the agenda of the first meeting of the committee responsible to take place after its communication. The Council may be invited to present its position. 2. Unless the committee responsible decides otherwise, the rapporteur at second reading shall be the same as the rapporteur at first reading. 3. The provisions of Rule 68(2) and (3) that concern the admissibility of the amendments to the Council's position shall apply to the proceedings in the committee responsible; only members or permanent substitutes of that committee may table proposals for rejection and amendments. The committee shall decide by a majority of the votes cast. 4. The committee responsible shall submit a recommendation for second reading, proposing the approval, amendment or rejection of the position adopted by the Council. The recommendation shall include a short justification for the decision proposed. 5. Rules 51, 52, 56 and 198 shall not apply during second reading. Rule 66 Submission to Parliament The Council's position and, where available, the committee responsible's recommendation for second reading shall be automatically placed on the draft agenda for the part-session the Wednesday of which falls before and closest to the day that the three month period or, if extended in accordance with Rule 64, the four month period, expires, unless the matter has been dealt with at an earlier part-session. Rule 67 Vote in Parliament — second reading 1. Parliament shall first vote on any proposal for the immediate rejection of Council's position that has been tabled in writing by the committee responsible, a political group or Members reaching at least the low threshold. For it to be adopted, such a proposal for rejection shall require the votes of a majority of the component Members of Parliament. If that proposal for rejection is adopted, the Council's position is rejected and the President shall announce in Parliament that the legislative procedure is closed. If that proposal for rejection is not adopted, Parliament shall then proceed in accordance with paragraphs 2 to 5. 2. Any provisional agreement tabled under Rule 74(4) by the committee responsible shall be given priority in voting and put to a single vote, unless, at the request of a political group or Members reaching at least the low threshold, Parliament decides to proceed immediately with the vote on amendments in accordance with paragraph 3. If, in a single vote, the provisional agreement secures the votes of a majority of the component Members of Parliament, the President shall announce in Parliament that the second reading of Parliament has been concluded. If, in a single vote, the provisional agreement fails to secure the majority of the component Members of Parliament, Parliament shall then proceed in accordance with paragraphs 3, 4 and 5. 3. Except where a proposal for rejection has been adopted in accordance with paragraph 1 or a provisional agreement has been adopted in accordance with paragraph 2, any amendments to the Council's position, including those contained in the provisional agreement tabled in accordance with Rule 74(4) by the committee responsible, shall then be put to the vote. Any amendment to the Council's position shall be adopted only if it secures the votes of a majority of the component Members of Parliament. Before voting on the amendments, the President may ask the Commission to state its position and the Council to comment. 4. Notwithstanding a vote by Parliament against the initial proposal to reject the Council's position under paragraph 1, Parliament may, on the proposal of the Chair or the rapporteur of the committee responsible or of a political group or Members reaching at least the low threshold, consider a further proposal for rejection after voting on the amendments under paragraphs 2 or 3. For it to be adopted, such a proposal shall require the votes of a majority of the component Members of Parliament. If the Council's position is rejected, the President shall announce in Parliament that the legislative procedure is closed. 5. After the votes taken under paragraphs 1 to 4 and the votes subsequently taken on amendments to the draft legislative resolution relating to procedural requests, the President shall announce that the second reading of Parliament has been concluded and the legislative resolution shall be deemed to have been adopted. If necessary, the legislative resolution shall be modified, pursuant to Rule 203(2), in order to reflect the outcome of the votes taken under paragraphs 1 to 4 or the application of Rule 69. The text of the legislative resolution and of Parliament's position, if any, shall be forwarded by the President to the Council and to the Commission. Where no proposal to reject or amend the Council's position has been tabled, it shall be deemed to have been approved. Rule 68 Admissibility of amendments to the Council's position 1. The committee responsible, a political group or Members reaching at least the low threshold may table amendments to the Council's position for consideration in Parliament. 2. An amendment to the Council's position shall be admissible only if it complies with Rules 180 and 181 and seeks: (a) to restore wholly or partly the position adopted by Parliament at its first reading; or (b) to reach a compromise between the Council and Parliament; or (c) to amend a part of the text of a Council position which was not included in — or differs in content from — the proposal submitted at first reading; or (d) to take account of a new fact or legal situation which has arisen since the adoption of Parliament's position at first reading. The President's discretion to declare an amendment admissible or inadmissible may not be questioned. 3. If new elections have taken place since the first reading, but Rule 61 has not been invoked, the President may decide to waive the restrictions on admissibility laid down in paragraph 2. Rule 69 Second-reading agreement Where no proposal to reject the Council's position and no amendments to that position have been tabled under Rules 67 and 68 within the time limits set for tabling and voting on amendments or on proposals to reject, the President shall announce in Parliament that the proposed act has been adopted. SECTION 3 — INTERINSTITUTIONAL NEGOTIATIONS DURING THE ORDINARY LEGISLATIVE PROCEDURE Rule 70 General provisions Negotiations with the other institutions aimed at reaching an agreement in the course of a legislative procedure may only be entered into following a decision taken in accordance with Rule 71, Rule 72 or Rule 73 or following a referral back by Parliament for interinstitutional negotiations. Such negotiations shall be conducted having regard to the Code of Conduct laid down by the Conference of Presidents (19). Rule 71 Negotiations ahead of Parliament's first reading 1. Where a committee has adopted a legislative report pursuant to Rule 51, it may decide, by a majority of its members, to enter into negotiations on the basis of that report. 2. Decisions to enter into negotiations shall be announced at the beginning of the part-session following their adoption in committee. By the end of the day following the announcement in Parliament, Members or a political group or groups reaching at least the medium threshold may request in writing that a committee decision to enter into negotiations be put to the vote. Parliament shall then proceed to that vote during the same part-session. If no such request is received by the expiry of the deadline laid down in the first subparagraph, the President shall inform Parliament that this is the case. If a request is made, the President may, immediately prior to the vote, give the floor to one speaker in favour of the committee's decision to enter into negotiations and to one speaker against that decision. Each speaker may make a statement lasting no more than two minutes. 3. If Parliament rejects the committee's decision to enter into negotiations, the draft legislative act and the report of the committee responsible shall be placed on the agenda of the following part-session, and the President shall set a deadline for amendments. Rule 59(4) shall apply. 4. Negotiations may start at any time after the deadline laid down in the first subparagraph of paragraph 2 has expired without a request for a vote in Parliament on the decision to enter into negotiations having been made. If such a request has been made, negotiations may start at any time after the committee decision to enter into negotiations has been approved in Parliament. Rule 72 Negotiations ahead of Council's first reading Where Parliament has adopted its position at first reading, that position shall constitute the mandate for any negotiations with other institutions. The committee responsible may decide, by a majority of its members, to enter into negotiations at any time thereafter. Such decisions shall be announced in Parliament during the part-session following the vote in committee and a reference to them shall be included in the minutes. Rule 73 Negotiations ahead of Parliament's second reading Where the Council position at first reading has been referred to the committee responsible, Parliament's position at first reading shall, subject to Rule 68, constitute the mandate for any negotiations with other institutions. The committee responsible may decide to enter into negotiations at any time thereafter. Where the Council position at first reading contains elements not covered by the draft legislative act or by Parliament's position at first reading, the committee may adopt guidelines, including in the form of amendments to the Council position, for the negotiating team. Rule 74 Conduct of negotiations 1. Parliament's negotiating team shall be led by the rapporteur and shall be presided over by the Chair of the committee responsible or by a Vice-Chair designated by the Chair. It shall at least consist of the shadow rapporteurs from each political group that wishes to participate. 2. Any document intended to be discussed at a meeting with the Council and the Commission (‘trilogue’) shall be circulated to the negotiating team at least 48 hours or, in cases of urgency, at least 24 hours in advance of that trilogue. 3. After each trilogue, the Chair of the negotiating team and the rapporteur shall, on behalf of the negotiating team, report back to the next meeting of the committee responsible. Where it is not feasible to convene a meeting of the committee in a timely manner, the Chair of the negotiating team and the rapporteur shall, on behalf of the negotiating team, report back to a meeting of the committee coordinators. 4. If negotiations lead to a provisional agreement, the committee responsible shall be informed without delay. Documents reflecting the outcome of the concluding trilogue shall be made available to the committee responsible and shall be published. The provisional agreement shall be submitted to the committee responsible, which shall decide, by way of a single vote by a majority of the votes cast, whether to approve it. If approved, it shall be tabled for consideration by Parliament, in a presentation which clearly indicates the modifications to the draft legislative act. 5. In the event of a disagreement between the committees concerned under Rules 57 and 58, the detailed rules for the opening of negotiations and the conduct of such negotiations shall be determined by the Chair of the Conference of Committee Chairs in accordance with the principles set out in those Rules. SECTION 4 — CONCILIATION AND THIRD READING Rule 75 Extension of time limits 1. The President shall, at the request of Parliament's delegation to the conciliation committee, extend the time limits for third reading in accordance with Article 294(14) of the Treaty on the Functioning of the European Union. 2. The President shall notify Parliament of any extension of time limits under Article 294(14) of the Treaty on the Functioning of the European Union, whether such extensions occur on the initiative of Parliament or of the Council. Rule 76 Convening of the Conciliation Committee Where the Council informs Parliament that it is unable to approve all of Parliament's amendments to the Council's position, the President shall, together with the Council, agree on a time and place for a first meeting of the Conciliation Committee. The six-week, or, if extended, eight-week, deadline provided for in Article 294(10) of the Treaty on the Functioning of the European Union shall run from the day on which the Committee first meets. Rule 77 Delegation to the Conciliation Committee 1. Parliament's delegation to the Conciliation Committee shall consist of a number of members equal to the number of members of the Council delegation. 2. The political composition of the delegation shall correspond to the composition of Parliament by political groups. The Conference of Presidents shall determine the exact number of Members from each political group that are to serve as members of Parliament's delegation. 3. The members of the delegation shall be appointed by the political groups for each conciliation case, preferably from among the members of the committee responsible, except for three members who shall be appointed as permanent members of successive delegations for a period of 12 months. The three permanent members shall be appointed by the political groups from among the Vice-Presidents and shall represent at least two different political groups. The Chair and the rapporteur in second reading of the committee responsible as well as the rapporteur of any associated committee shall in each case be members of the delegation. 4. The political groups represented on the delegation shall appoint substitutes. 5. Political groups not represented on the delegation may each send one representative to any internal preparatory meeting of the delegation. If the delegation does not include any non-attached Members, one non-attached Member may attend any internal preparatory meetings of the delegation. 6. The delegation shall be led by the President or by one of the three permanent members. 7. The delegation shall decide by a majority of its members. Its deliberations shall not be public. The Conference of Presidents shall lay down further procedural guidelines for the work of the delegation to the Conciliation Committee. 8. The delegation shall report back the results of the conciliation to Parliament. Rule 78 Joint text 1. Where agreement on a joint text is reached within the Conciliation Committee, the matter shall be placed on the agenda of a sitting of Parliament to be held within six or, if extended, eight weeks of the date of approval of the joint text by the Conciliation Committee. 2. The Chair or another designated member of Parliament's delegation to the Conciliation Committee shall make a statement on the joint text, which shall be accompanied by a report. 3. No amendments may be tabled to the joint text. 4. The joint text as a whole shall be the subject of a single vote. The joint text shall be approved if it secures a majority of the votes cast. 5. If no agreement is reached on a joint text within the Conciliation Committee, the Chair or another designated member of Parliament's delegation to the Conciliation Committee shall make a statement. That statement shall be followed by a debate. 6. During the conciliation procedure between Parliament and the Council following the second reading, no referral back to committee shall take place. 7. Rules 51, 52 and 56 shall not apply during third reading. SECTION 5 — CONCLUSION OF THE PROCEDURE Rule 79 Signing and publication of adopted acts After finalisation of the text adopted in accordance with Rule 203 and Annex VIII and once it has been verified that all the procedures have been duly completed, acts adopted in accordance with the ordinary legislative procedure shall be signed by the President and the Secretary-General. After signature of the act, the Secretaries-General of Parliament and of the Council shall arrange for its publication in the Official Journal of the European Union. CHAPTER 4 Provisions specific to the consultation procedure Rule 80 Modified proposal for a legally binding act If the Commission intends to replace or modify its proposal for a legally binding act, the committee responsible may postpone its examination of the matter until it has received the new proposal or the amendments of the Commission. Rule 81 Commission position on amendments Before the committee responsible proceeds to the final vote on a proposal for a legally binding act, it may ask the Commission to state its position on all the amendments to the proposal that the committee has adopted. If appropriate, that position shall be included in the report. Rule 82 Vote in Parliament Rule 59(1), (2), (4) and (5) shall apply mutatis mutandis. Rule 83 Follow-up to Parliament's position 1. In the period following the adoption by Parliament of its position on a draft legally binding act, the Chair and the rapporteur of the committee responsible shall monitor the progress of that draft act over the course of the procedure leading to its adoption by the Council, in particular in order to ensure that any undertakings given by the Council or the Commission to Parliament concerning its position are properly observed. The Chair and the rapporteur of the committee responsible shall report back to the committee regularly. 2. The committee responsible may invite the Commission and the Council to discuss the matter with it. 3. At any stage of the follow-up procedure, the committee responsible may, if it deems it to be necessary, table a motion for a resolution recommending that Parliament: — call upon the Commission to withdraw its proposal, — call upon the Commission or the Council to refer the matter to Parliament once again, pursuant to Rule 84, or call upon the Commission to present a new proposal, or — decide to take any other action that it deems to be appropriate. Such motion shall be placed on the draft agenda of the part-session following the adoption of the motion by the committee. Rule 84 Renewed referral to Parliament 1. At the request of the committee responsible, the President shall call on the Council to reconsult Parliament in the same circumstances and under the same conditions as those set out in Rule 61(1). At the request of the committee responsible, the President shall also call on the Council to reconsult Parliament where the Council substantially amends or intends to substantially amend the draft legally binding act on which Parliament originally delivered its position, except where this is done in order to incorporate Parliament's amendments. 2. The President shall also request that a draft legally binding act be referred again to Parliament in the circumstances defined in this Rule where, on a proposal from a political group or Members reaching at least the low threshold, Parliament so decides. CHAPTER 5 Constitutional matters Rule 85 Ordinary Treaty revision 1. In accordance with Rules 46 and 54, the committee responsible may submit to Parliament a report containing proposals, addressed to the Council, for the amendment of the Treaties. 2. Where Parliament is consulted, in accordance with Article 48(3) of the Treaty on European Union, on a proposal for a decision of the European Council in favour of examining amendments to the Treaties, the matter shall be referred to the committee responsible. The committee shall draw up a report comprising: — a motion for a resolution which states whether Parliament approves or rejects the proposed decision and which may contain proposals for the attention of the Convention or of the conference of representatives of the governments of the Member States, — if appropriate, an explanatory statement. 3. If the European Council decides to convene a Convention, Parliament shall, on a proposal by the Conference of Presidents, appoint Parliament's representatives to that Convention. Parliament's delegation shall elect its leader and its candidates for membership of any steering group or bureau set up by the Convention. 4. Where the European Council requests Parliament's consent to a decision not to convene a Convention for the examination of proposed amendments of the Treaties, this request shall be referred to the committee responsible in accordance with Rule 105. Rule 86 Simplified Treaty revision 1. In accordance with Rules 46 and 54, the committee responsible may submit to Parliament, in accordance with the procedure laid down in Article 48(6) of the Treaty on European Union, a report containing proposals, addressed to the European Council, for the revision of all or part of the provisions of Part Three of the Treaty on the Functioning of the European Union. 2. Where Parliament is consulted, in accordance with Article 48(6) of the Treaty on European Union, on a proposal for a decision of the European Council amending Part Three of the Treaty on the Functioning of the European Union, Rule 85(2) shall apply mutatis mutandis. In that event, the motion for a resolution may contain proposals for amendments only of provisions of Part Three of the Treaty on the Functioning of the European Union. Rule 87 Accession treaties 1. Any application by a European State to become a member of the European Union, in accordance with Article 49 of the Treaty on European Union, shall be referred for consideration to the committee responsible. 2. Parliament may, on a proposal from the committee responsible, a political group or Members reaching at least the low threshold, decide to request the Commission and the Council to take part in a debate before any accession negotiations with the applicant State commence. 3. The committee responsible shall request the Commission and the Council to provide it with full and regular information about the progress of the accession negotiations, if necessary on a confidential basis. 4. At any stage of the accession negotiations, Parliament may, on the basis of a report from the committee responsible, adopt recommendations and require that those recommendations be taken into account before the conclusion of a Treaty for the accession of an applicant State to the European Union. 5. When the accession negotiations have been completed, but before any agreement is signed, the draft agreement shall be submitted to Parliament for its consent, in accordance with Rule 105. In accordance with Article 49 of the Treaty on European Union, the consent of Parliament shall require the votes of a majority of its component members. Rule 88 Withdrawal from the Union If a Member State decides, pursuant to Article 50 of the Treaty on European Union, to withdraw from the Union, the matter shall be referred to the committee responsible. Rule 87 shall apply mutatis mutandis. Parliament shall decide whether to give its consent to an agreement on the withdrawal by a majority of the votes cast. Rule 89 Breach by a Member State of fundamental principles and values 1. Parliament may, on the basis of a specific report of the committee responsible drawn up in accordance with Rules 46 and 54: (a) vote on a reasoned proposal calling on the Council to act pursuant to Article 7(1) of the Treaty on European Union; (b) vote on a proposal calling on the Commission or the Member States to submit a proposal pursuant to Article 7(2) of the Treaty on European Union; (c) vote on a proposal calling on the Council to act pursuant to Article 7(3) or, subsequently, Article 7(4) of the Treaty on European Union. 2. Any request from the Council for consent in relation to a proposal submitted pursuant to Article 7(1) and (2) of the Treaty on European Union shall, along with any observations submitted by the Member State in question, be announced to Parliament and referred to the committee responsible, in accordance with Rule 105. Except in urgent and justified circumstances, Parliament shall take its decision on a proposal from the committee responsible. 3. In accordance with Article 354 of the Treaty on the Functioning of the European Union, the adoption by Parliament of decisions on proposals referred to in paragraphs 1 and 2 of this Rule shall require a two-thirds majority of the votes cast, representing a majority of its component Members. 4. Subject to the authorisation of the Conference of Presidents, the committee responsible may submit an accompanying motion for a resolution. That motion for a resolution shall set out Parliament's views on a serious breach by a Member State, on the appropriate measures to be taken and on varying or revoking those measures. 5. The committee responsible shall ensure that Parliament is kept fully informed and, where necessary, asked for its views on all follow-up measures to its consent as given pursuant to paragraph 3. The Council shall be invited to outline developments as appropriate. On a proposal from the committee responsible, drawn up with the authorisation of the Conference of Presidents, Parliament may adopt recommendations for the Council. Rule 90 Composition of Parliament In good time before the end of a parliamentary term, Parliament may, on the basis of a report drawn up by its committee responsible, in accordance with Article 14(2) of the Treaty on European Union and with Rules 46 and 54, make a proposal to modify its composition. The European Council's draft decision establishing the composition of Parliament shall be examined by Parliament in accordance with Rule 105. Rule 91 Enhanced cooperation between Member States 1. Requests for the introduction of enhanced cooperation between Member States pursuant to Article 20 of the Treaty on European Union shall be referred by the President to the committee responsible for consideration. Rule 105 shall apply. 2. The committee responsible shall verify compliance with Article 20 of the Treaty on European Union and Articles 326 to 334 of the Treaty on the Functioning of the European Union. 3. Acts subsequently proposed under enhanced cooperation, once it is established, shall be dealt with in Parliament in accordance with the same procedures as those which would have applied if no enhanced cooperation had been established. Rule 48 shall apply. CHAPTER 6 Budgetary procedures Rule 92 Multiannual financial framework Where the Council requests Parliament's consent to the proposal for a regulation laying down the multiannual financial framework, the matter shall be dealt with in accordance with Rule 105. In accordance with the first subparagraph of Article 312(2) of the Treaty on the Functioning of the European Union, Parliament's consent shall require the votes of a majority of its component Members. Rule 93 Annual budgetary procedure The committee responsible may decide to draw up any report that is deemed to be appropriate concerning the budget, having regard to the Annex to the Interinstitutional Agreement on budgetary discipline, on cooperation in budgetary matters and on sound financial management (20). Any other committee may deliver an opinion within the time limit set by the committee responsible. Rule 94 Parliament's position on the draft budget 1. Individual Members may table amendments to the Council's position on the draft budget in the committee responsible. A political group or Members reaching at least the low threshold or a committee may table in Parliament amendments to the Council's position on the draft budget. 2. Amendments shall be presented and justified in writing, bear the signature of their authors and specify the budget line to which they refer. 3. The President shall set the time limit for the tabling of amendments. 4. The committee responsible shall vote on the amendments before they are discussed in Parliament. 5. Amendments tabled in Parliament which have been rejected in the committee responsible may only be put to the vote if this has been requested in writing, before a deadline to be set by the President, by a committee or by a political group or Members reaching at least the low threshold. That deadline shall not be less than 24 hours before the start of the vote. 6. In the case of amendments to the estimates of Parliament which are similar to those already rejected by Parliament at the time when the estimates were drawn up, Parliament shall discuss them only where the committee responsible has delivered a favourable opinion. 7. Parliament shall take successive votes: — on the amendments to Council's position on the draft budget, section by section, — on a motion for a resolution concerning the draft budget. However, Rule 183(4) to (10) shall apply. 8. Articles, chapters, titles and sections of the draft budget in respect of which no amendments have been tabled shall be deemed to have been adopted. 9. In accordance with Article 314(4)(c) of the Treaty on the Functioning of the European Union, amendments shall require for adoption the votes of a majority of the component Members of Parliament. 10. If Parliament has amended the Council's position on the draft budget, the position as amended shall be forwarded to the Council and the Commission, together with the justifications and the minutes of the sitting at which the amendments were adopted. Rule 95 Budgetary conciliation 1. The President shall convene the Conciliation Committee in accordance with Article 314(4) of the Treaty on the Functioning of the European Union. 2. The delegation representing Parliament at meetings of the Conciliation Committee in the budgetary procedure shall consist of a number of members equal to that of the Council delegation. 3. Each year, prior to Parliament's vote on the Council's position, the political groups shall appoint the members of Parliament's delegation to the Conciliation Committee, preferably from amongst the members of the committee responsible for budgetary issues and other committees concerned. The delegation shall be led by the President of Parliament. The President may delegate this role to a Vice-President who has experience of budgetary matters or to the Chair of the committee responsible for budgetary issues. 4. Rule 77(2), (4), (5), (7) and (8) shall apply. 5. Where agreement on a joint text is reached within the Conciliation Committee, the matter shall be placed on the agenda of a sitting of Parliament to be held within 14 days from the date of that agreement. The joint text shall be made available to all Members. Rule 78(2) and (3) shall apply. 6. The joint text as a whole shall be put to a single vote. The vote shall be taken by roll-call vote. The joint text shall be deemed to have been approved unless it is rejected by a majority of the component Members of Parliament. 7. If Parliament approves the joint text whilst the Council rejects it, the committee responsible may table all or some of Parliament's amendments to the Council's position for a confirmation in accordance with point (d) of Article 314(7) of the Treaty on the Functioning of the European Union. The vote on the confirmation shall be placed on the agenda of a sitting of Parliament to be held within 14 days from the date of the communication by the Council of its rejection of the joint text. The amendments shall be deemed to be confirmed if they are approved by a majority of the component Members of Parliament and three fifths of the votes cast. Rule 96 Definitive adoption of the budget Where the President considers that the budget has been adopted in accordance with the provisions of Article 314 of the Treaty on the Functioning of the European Union, he or she shall declare in Parliament that the budget has been definitively adopted. The President shall arrange for its publication in the Official Journal of the European Union. Rule 97 Provisional twelfths system 1. Any decision by the Council authorising expenditure in excess of the provisional one twelfth of the budget appropriations for the preceding financial year shall be referred to the committee responsible. 2. The committee responsible may table a draft decision to reduce the expenditure referred to in paragraph 1. Parliament shall decide on it within 30 days after the adoption of the Council's decision. 3. Parliament shall act by a majority of its component Members. Rule 98 Implementation of the budget 1. Parliament shall monitor the implementation of the current year's budget. It shall entrust this task to the committees responsible for the budget and budgetary control and to the other committees concerned. 2. Each year, before its reading of the draft budget for the following financial year, Parliament shall consider the problems involved in the implementation of the current budget, where appropriate on the basis of a motion for a resolution tabled by its committee responsible. Rule 99 Discharge to the Commission in respect of implementation of the budget The provisions governing the procedure for granting discharge to the Commission in respect of the implementation of the budget in accordance with the financial provisions of the Treaty on the Functioning of the European Union and Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (21) (the ‘Financial Regulation’) are attached to these Rules as an annex (22). Rule 100 Other discharge procedures The provisions governing the procedure for granting discharge to the Commission in accordance with Article 319 of the Treaty on the Functioning of the European Union, in respect of the implementation of the budget, shall also apply to the procedure for granting discharge to: — the President of the European Parliament in respect of the implementation of the budget of the European Parliament; — the persons responsible for the implementation of the budgets of other institutions and bodies of the European Union such as the Council, the Court of Justice of the European Union, the Court of Auditors, the European Economic and Social Committee and the Committee of the Regions; — the Commission in respect of the implementation of the budget of the European Development Fund; — the bodies responsible for the budgetary management of legally independent entities which carry out Union tasks, insofar as their activities are subject to legal provisions requiring discharge by the European Parliament. Rule 101 Interinstitutional cooperation In accordance with Article 324 of the Treaty on the Functioning of the European Union, the President shall participate in regular meetings between the Presidents of the European Parliament, the Council and the Commission convened, on the initiative of the Commission, under the budgetary procedures referred to in Title II of Part Six of the Treaty on the Functioning of the European Union. The President shall take all the necessary steps to promote consultation and the reconciliation of the positions of the institutions in order to facilitate the implementation of the procedures aforementioned. The President of Parliament may delegate this task to a Vice-President who has experience of budgetary matters or to the Chair of the committee responsible for budgetary issues. CHAPTER 7 Internal budgetary procedures Rule 102 Estimates of Parliament 1. The Bureau shall draw up the preliminary draft estimates on the basis of a report prepared by the Secretary-General. 2. The President shall forward the preliminary draft estimates to the committee responsible, which shall draw up the draft estimates and report to Parliament. 3. The President shall set a time limit for tabling amendments to the draft estimates. The committee responsible shall give its opinion on these amendments. 4. Parliament shall adopt the estimates. 5. The President shall forward the estimates to the Commission and the Council. 6. The foregoing provisions shall also apply to estimates for amending budgets. Rule 103 Procedure to be applied when drawing up Parliament's estimates 1. As regards Parliament's budget, the Bureau and the committee responsible for budgetary issues shall take decisions in successive stages on: (a) the establishment plan; (b) the preliminary draft and the draft estimates. 2. The decisions concerning the establishment plan will be taken in accordance with the following procedure: (a) the Bureau shall draw up the establishment plan for each financial year; (b) a conciliation procedure between the Bureau and the committee responsible for budgetary issues shall be opened in cases where the opinion of that committee diverges from the initial decisions taken by the Bureau; (c) at the end of the procedure, the Bureau shall take the final decision on the estimates for the establishment plan, in accordance with Rule 234(3), without prejudice to decisions taken pursuant to Article 314 of the Treaty on the Functioning of the European Union. 3. As regards the estimates proper, the procedure for drawing up the estimates will begin as soon as the Bureau has taken a final decision on the establishment plan. The stages of that procedure will be those laid down in Rule 102. A conciliation procedure shall be opened in cases where the positions of the committee responsible for budgetary issues and of the Bureau are widely divergent. Rule 104 Power to incur and settle expenditure, to approve accounts and to grant discharge 1. The President shall incur and settle, or cause to be incurred and settled, the expenditure covered by the internal financial regulations issued by the Bureau after consulting the appropriate committee. 2. The President shall forward the draft annual accounts to the committee responsible. 3. On the basis of a report by the committee responsible, Parliament shall approve its accounts and decide on the granting of a discharge. CHAPTER 8 Consent procedure Rule 105 Consent procedure 1. Where Parliament is asked to give its consent to a legally binding act, the committee responsible shall submit to Parliament a recommendation to approve or reject the proposed act. The recommendation shall include citations but shall not include recitals. Amendments in committee shall be admissible only if they aim to reverse the recommendation proposed by the rapporteur. The recommendation may be accompanied by a short explanatory statement. That statement shall be the sole responsibility of the rapporteur and shall not be put to the vote. Rule 55(2) shall apply mutatis mutandis. 2. The committee responsible may also, if necessary, table a report, including a motion for a non-legislative resolution setting out the reasons why Parliament should give or refuse its consent and, where appropriate, making recommendations for the implementation of the proposed act. 3. The committee responsible shall deal with the request for consent without undue delay. If the committee responsible has not adopted its recommendation within six months after the request for consent was referred to it, the Conference of Presidents may either place the matter on the agenda for consideration at a subsequent part-session or, in duly justified cases, decide to extend the six-month period. 4. Parliament shall decide on the proposed act by means of a single vote on consent, regardless of whether the recommendation from the committee responsible is to approve or reject the act, and no amendments may be tabled. If the majority required is not obtained, the proposed act shall be deemed to have been rejected. 5. Where Parliament's consent is required, the committee responsible may, at any time, present an interim report to Parliament, including a motion for a resolution containing recommendations for the modification or the implementation of the proposed act. CHAPTER 9 Other procedures Rule 106 Procedure for delivering opinions on derogations to the adoption of the euro 1. When Parliament is consulted pursuant to Article 140(2) of the Treaty on the Functioning of the European Union, the committee responsible shall submit a report to Parliament advocating approval or rejection of the proposed act on the basis of which Parliament shall deliberate. 2. Parliament shall take a single vote on the proposed act, to which no amendments may be tabled. Rule 107 Procedures relating to dialogue between management and labour 1. The President shall refer any document drawn up by the Commission pursuant to Article 154 of the Treaty on the Functioning of the European Union or agreements reached by management and labour pursuant to Article 155(1) of that Treaty, as well as any proposals submitted by the Commission under Article 155(2) of that Treaty, to the committee responsible, for consideration. 2. Where management and labour inform the Commission of their wish to initiate the process provided for in Article 155 of the Treaty on the Functioning of the European Union, the committee responsible may draw up a report on the substantive issue in question. 3. Where management and labour have reached an agreement and have requested jointly that their agreement be implemented by a Council decision on a proposal from the Commission in accordance with Article 155(2) of the Treaty on the Functioning of the European Union, the committee responsible shall table a motion for a resolution recommending the adoption or rejection of the request. Rule 108 Procedures for scrutiny of envisaged voluntary agreements 1. Where the Commission informs Parliament of its intention to explore the use of voluntary agreements as an alternative to legislation, the committee responsible may draw up a report on the substantive issue in question pursuant to Rule 54. 2. Where the Commission announces that it intends to enter into a voluntary agreement, the committee responsible may table a motion for a resolution recommending that Parliament approve or reject the proposal, and under what conditions. Rule 109 Codification 1. When a proposal for codification of Union legislation is submitted to Parliament, it shall be referred to the committee responsible for legal affairs. That committee shall examine the proposal in accordance with the arrangements agreed at interinstitutional level (23) in order to ascertain that the proposal is a straightforward codification, with no changes of a substantive nature. 2. The committee which was responsible for the acts to be codified may, at its own request or at the request of the committee responsible for legal affairs, be asked to deliver an opinion on the desirability of codification. 3. Amendments to the text of the proposal shall be inadmissible. However, the Chair of the committee responsible for legal affairs may, at the rapporteur's request, submit, for that committee's approval, technical adaptations, provided that those adaptations do not involve any substantive change to the proposal and are necessary in order to ensure that the proposal complies with the codification rules. 4. If the committee responsible for legal affairs concludes that the proposal does not entail any substantive change to Union legislation, it shall refer it to Parliament for approval. If the committee responsible for legal affairs takes the view that the proposal entails a substantive change, it shall propose that Parliament reject the proposal. In either of those two cases, Parliament shall adopt a decision by means of a single vote, without amendment or debate. Rule 110 Recasting 1. Where a proposal recasting Union legislation is submitted to Parliament, it shall be referred to the committee responsible for legal affairs and to the committee responsible for the subject-matter. 2. The committee responsible for legal affairs shall examine the proposal in accordance with the arrangements agreed at interinstitutional level (24) in order to check that it entails no substantive changes other than those identified as such in the proposal. For the purpose of that examination, amendments to the text of the proposal shall be inadmissible. However, the second subparagraph of Rule 109(3) shall apply to provisions which remain unchanged in the recasting proposal. 3. If the committee responsible for legal affairs considers that the proposal does not entail any substantive changes other than those identified as such in the proposal, it shall inform the committee responsible for the subject matter thereof. In such a case, over and above the conditions laid down in Rules 180 and 181, amendments shall be admissible within the committee responsible for the subject-matter only if they concern those parts of the proposal which contain changes. However, amendments to parts of the proposal which remain unchanged may, by way of exception and on a case-by-case basis, be accepted by the Chair of the committee responsible for the subject matter if he or she considers that this is necessary for pressing reasons relating to the internal logic of the text or because the amendments are inextricably linked to other admissible amendments. Such reasons must be stated in a written justification to the amendments. 4. If the committee responsible for legal affairs considers that the proposal entails substantive changes other than those which have been identified as such in the proposal, it shall propose that Parliament reject the proposal and shall inform the committee responsible for the subject-matter that it has done so. In such a case the President shall ask the Commission to withdraw it. If the Commission does so, the President shall declare that the procedure in Parliament is superfluous and shall inform the Council accordingly. If the Commission does not withdraw its proposal, Parliament shall refer it back to the committee responsible for the subject-matter, which shall consider it in accordance with the normal procedure. CHAPTER 10 Delegated and implementing acts Rule 111 Delegated acts 1. When the Commission forwards a delegated act to Parliament, the President shall refer it to the committee responsible for the basic legislative act, which may decide to designate one of its members to consider one or more delegated acts. 2. During the part-session following its reception, the President shall announce to Parliament the date on which the delegated act was received in all the official languages and the period during which objections may be raised. The period in question shall commence on the date of reception. The announcement shall be published in the minutes of the sitting, together with the name of the committee responsible. 3. In accordance with the provisions of the basic legislative act and — if the committee responsible considers it appropriate to do so — after consulting any other committees concerned, the committee responsible may table a reasoned motion for a resolution objecting to the delegated act. If, 10 working days before the start of the part-session of which the Wednesday falls before and closest to the day of expiry of the deadline referred to in paragraph 5, the committee responsible has not tabled such a motion for a resolution, a political group or Members reaching at least the low threshold may table a motion for a resolution on the matter for inclusion on the agenda for the part-session referred to above. 4. Any motion for a resolution tabled in accordance with paragraph 3 shall state the reasons for Parliament's objections and may incorporate a request calling on the Commission to submit a new delegated act which takes account of Parliament's recommendations. 5. Parliament shall approve such a motion by the deadline laid down in the basic legislative act and, in accordance with the second subparagraph of Article 290(2) of the Treaty on the Functioning of the European Union, by a majority of its component Members. Where the committee responsible considers that it is appropriate to extend the deadline for raising objections to the delegated act in accordance with the provisions of the basic legislative act, the committee Chair shall notify the Council and the Commission, on behalf of Parliament, of that extension. 6. If the committee responsible recommends that, prior to the expiry of the deadline set in the basic legislative act, Parliament should declare that it has no objections to the delegated act: — the committee responsible shall inform the Chair of the Conference of Committee Chairs by means of a letter setting out its reasons and table a recommendation to that effect, — if no objections are raised at the next meeting of the Conference of Committee Chairs, or, on grounds of urgency, by written procedure, the Chair of that body shall inform the President of Parliament, who shall in turn inform the plenary as soon as possible, — if, within 24 hours following the announcement in Parliament, a political group or Members reaching at least the low threshold object to the recommendation, it shall be put to the vote, — if, within the same period, no objections are raised, the proposed recommendation shall be deemed to have been approved, — the adoption of such a recommendation shall render inadmissible any subsequent proposal objecting to the delegated act. 7. The committee responsible may, in accordance with the provisions of the basic legislative act, submit to Parliament a motion for a resolution revoking, in full or in part, that delegation of powers or opposing the tacit extension of that delegation of powers. In accordance with the second subparagraph of Article 290(2) of the Treaty on the Functioning of the European Union, a decision to revoke the delegation of powers shall require the votes of a majority of Parliament's component Members. 8. The President shall inform the Council and Commission of the positions taken under this Rule. Rule 112 Implementing acts and measures 1. When the Commission forwards a draft implementing act or measure to Parliament, the President shall refer it to the committee responsible for the basic legislative act, which may decide to designate one of its members to consider one or more draft implementing acts or measures. 2. The committee responsible may table a reasoned motion for a resolution stating that a draft implementing act or measure goes beyond the implementing powers conferred in the basic legislative act or is not consistent with Union law in other respects. 3. The motion for a resolution may incorporate a request to the Commission to withdraw the draft implementing act or measure, to amend it in keeping with the objections raised by Parliament, or to submit a new legislative proposal. The President shall inform the Council and the Commission of the decision taken. 4. If the implementing acts envisaged by the Commission fall under the regulatory procedure with scrutiny provided for by Council Decision 1999/468/EC (25), the following additional provisions shall apply: (a) the time for scrutiny shall start to run when the draft implementing measure has been submitted to Parliament in all the official languages. Where the shorter time limit for scrutiny provided for in Article 5a(5)(b) of Decision 1999/468/EC applies, and in the urgent cases provided for in Article 5a(6) of that Decision, the time for scrutiny shall, unless the Chair of the committee responsible objects, start to run from the date of receipt by Parliament of the final draft implementing measure in the language versions submitted to the members of the committee set up in accordance with that Decision. Rule 167 shall not apply in the two instances mentioned in the previous sentence; (b) if the draft implementing measure is based on paragraph 5 or 6 of Article 5a of Decision 1999/468/EC, which prescribes curtailed time limits for opposition by Parliament, a motion for a resolution opposing the adoption of the draft measure may be tabled by the Chair of the committee responsible if that committee has not been able to meet in the time available; (c) Parliament, acting by a majority of its component Members, may adopt a resolution opposing the adoption of the draft implementing measure and indicating that the draft exceeds the implementing powers conferred in the basic act, is not compatible with the aim or the content of the basic act or does not respect the principles of subsidiarity or proportionality. If, 10 working days prior to the start of the part-session of which the Wednesday falls before and closest to the day of expiry of the deadline for opposing the adoption of the draft implementing measure, the committee responsible has not tabled a motion for such a resolution, a political group or Members reaching at least the low threshold may table a motion for a resolution on the matter for inclusion on the agenda for the part-session referred to above; (d) if the committee responsible recommends, by means of a letter to the Chair of the Conference of Committee Chairs setting out its reasons, that Parliament should declare that it has no objections to the proposed measure prior to the expiry of the normal time limit laid down in Article 5a(3)(c) and/or Article 5a(4)(e) of Decision 1999/468/EC, the procedure provided for in Rule 111(6) shall apply (26). Rule 113 Consideration under the associated committee procedure or the joint committee procedure 1. If the basic legislative act was adopted by Parliament under the procedure provided for in Rule 57, the following additional provisions shall apply to the consideration of the delegated acts or draft implementing acts or measures: — the delegated act or draft implementing act or measure shall be forwarded to the committee responsible and to the associated committee, — the Chair of the committee responsible shall set a deadline by which the associated committee may draw up proposals on matters falling within its exclusive competence or within the joint competence of the two committees, — if the delegated act or draft implementing act or measure falls mainly within the exclusive competence of the associated committee, the committee responsible shall accept its proposals without a vote; if the committee responsible fails to respect this rule, the President may authorise the associated committee to table a motion for a resolution in plenary. 2. If the basic legislative act was adopted by Parliament under the procedure provided for in Rule 58, the following additional provisions shall apply to the consideration of delegated acts and draft implementing acts or measures: — upon receipt of the delegated act or draft implementing act or measure, the President shall determine which committee is responsible or which committees are jointly responsible for it, in accordance with the criteria laid down in Rule 58 and with any agreements reached between the Chairs of the committees concerned, — if a delegated act or a draft implementing act or measure has been forwarded for consideration under the joint committee procedure, each committee may request that a joint meeting be convened to consider a motion for a resolution. If the Chairs of the committees concerned fail to reach agreement, the joint meeting shall be convened by the Chair of the Conference of Committee Chairs. TITLE III EXTERNAL RELATIONS CHAPTER 1 International agreements Rule 114 International agreements 1. When it is intended to open negotiations on the conclusion, renewal or amendment of an international agreement, the committee responsible may decide to draw up a report or otherwise monitor the preparatory phase. It shall inform the Conference of Committee Chairs of its decision. 2. The committee responsible shall, as soon as possible, ascertain from the Commission the chosen legal basis for concluding the international agreements referred to in paragraph 1. The committee responsible shall verify that chosen legal basis in accordance with Rule 40. 3. Parliament may, on a proposal from the committee responsible, a political group or Members reaching at least the low threshold, ask the Council not to authorise the opening of negotiations until Parliament has stated its position on the proposed negotiating mandate on the basis of a report from the committee responsible. 4. At any stage of the negotiations and from the end of the negotiations to the conclusion of the international agreement, Parliament may, on the basis of a report from the committee responsible, drawn up by that committee on its own initiative or after considering any relevant proposal tabled by a political group or Members reaching at least the low threshold, adopt recommendations to the Council, the Commission or the Vice President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy and require them to be taken into account before the conclusion of that agreement. 5. Requests by the Council for Parliament's consent or opinion shall be referred by the President to the committee responsible for consideration in accordance with Rule 105 or Rule 48(1). 6. At any time before Parliament votes on a request for consent or opinion, the committee responsible or at least one-tenth of Parliament's component Members may propose that Parliament seek an opinion from the Court of Justice on the compatibility of an international agreement with the Treaties. Before Parliament votes on that proposal, the President may request the opinion of the committee responsible for legal affairs, which shall report its conclusions to Parliament. If Parliament approves the proposal to seek an opinion from the Court of Justice, the vote on a request for consent or opinion shall be adjourned until the Court has delivered its opinion. 7. Where the Council requests that Parliament give its consent to the conclusion, renewal or amendment of an international agreement, Parliament shall decide by a single vote in accordance with Rule 105. If Parliament declines to give its consent, the President shall inform the Council that the agreement in question cannot be concluded, renewed or amended. Without prejudice to Rule 105(3), Parliament may decide, on the basis of a recommendation from the committee responsible, to postpone its decision on the consent procedure for no longer than one year. 8. Where the Council requests that Parliament gives its opinion on the conclusion, renewal or amendment of an international agreement, no amendments to the text of the agreement shall be admissible. Without prejudice to Rule 181(1), amendments to the draft Council decision shall be admissible. If that opinion adopted by Parliament is unfavourable, the President shall ask the Council not to conclude the agreement in question. 9. The Chairs and rapporteurs of the committee responsible, and of any associated committees, shall jointly check that, in accordance with Article 218(10) of the Treaty on the Functioning of the European Union, the Council, the Commission and the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy immediately and regularly provide Parliament with full information, if necessary on a confidential basis, at all stages of the preparations for the negotiation, the negotiation and the conclusion of international agreements, including information on the draft and the finally adopted text of negotiating directives, as well as information relating to the implementation of those agreements. Rule 115 Provisional application or suspension of the application of international agreements or establishment of the Union's position in a body set up by an international agreement Where the Commission or the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy informs Parliament and the Council of its intention to propose the provisional application or suspension of an international agreement, Parliament may invite the Council, the Commission or the Vice-President/High Representative to make a statement, following which there shall be a debate. Parliament may issue recommendations on the basis of a report by the committee responsible or pursuant to Rule 118, which may include, in particular, a request to the Council not to provisionally apply an agreement until the Parliament has given consent. That procedure shall also apply when the Commission or the Vice-President/High Representative proposes positions to be adopted on the Union's behalf in a body set up by an international agreement. CHAPTER 2 External representation of the Union and the common foreign and security policy Rule 116 Special representatives 1. Where the Council intends to appoint a special representative under Article 33 of the Treaty on European Union, the President, at the request of the committee responsible, shall invite the Council to make a statement, and to answer questions, concerning the mandate, the objectives and other relevant matters relating to the tasks and role to be performed by the special representative. 2. After the special representative has been appointed, but before he or she has taken up that position, he or she may be invited to appear before the committee responsible to make a statement and answer questions. 3. Within two months after the hearing, the committee responsible may make recommendations to the Council, to the Commission or to the Vice President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy relating directly to the appointment. 4. The special representative shall be invited to keep Parliament fully and regularly informed concerning the practical implementation of the mandate. Rule 117 International representation 1. Before appointment, the nominee for a post of head of a Union external delegation may be invited to appear before the committee responsible in order to make a statement and to answer questions. 2. Within two months of the hearing provided for in paragraph 1, the committee responsible may adopt a resolution or make a recommendation, as appropriate, relating directly to the appointment. CHAPTER 3 Recommendations on the Union's external action Rule 118 Recommendations on the Union's external policies 1. The committee responsible may draw up draft recommendations for the Council, for the Commission or for the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy on subjects under Title V of the Treaty on European Union (the Union's external action), or in cases where an international agreement falling within the scope of Rule 114 has not been referred to Parliament or Parliament has not been informed thereof under Rule 115. 2. In urgent cases, the President may authorise an emergency meeting of the committee concerned. 3. During the procedure for adopting those draft recommendations at committee stage, it shall be necessary for a written text to be put to the vote. 4. In the urgent cases referred to in paragraph 2, Rule 167 shall not apply at committee stage, and oral amendments shall be admissible. Members may not object to oral amendments being put to the vote in committee. 5. The draft recommendations drawn up by the committee shall be included on the agenda for the next part-session. In urgent cases decided upon by the President, recommendations may be included on the agenda for a current part-session. 6. Recommendations shall be deemed to have been adopted unless, before the beginning of the part-session, a political group or Members reaching at least the low threshold submit a written objection. Where such an objection is submitted, the committee's draft recommendations shall be included on the agenda of the same part-session. Such recommendations shall be the subject of a debate, and any amendment tabled by a political group or Members reaching at least the low threshold shall be put to the vote. Rule 119 Consultation of, and provision of information to, Parliament within the framework of the common foreign and security policy 1. When Parliament is consulted pursuant to Article 36 of the Treaty on European Union, the matter shall be referred to the committee responsible, which may draw up draft recommendations pursuant to Rule 118. 2. The committees concerned shall seek to ensure that the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy provides them, regularly and in a timely manner, with information on the development and implementation of the Union's common foreign and security policy, on the costs envisaged each time that a decision entailing expenditure is adopted under that policy and on any other financial considerations relating to the implementation of actions under that policy. Exceptionally, at the request of the Vice-President/High Representative, a committee may decide to hold its proceedings in camera. 3. Twice a year, a debate shall be held on the consultative document drawn up by the Vice-President/High Representative on the main aspects and basic choices of the common foreign and security policy, including the common security and defence policy and the financial implications for the Union budget. The procedures laid down in Rule 132 shall apply. 4. The Vice-President/High Representative shall be invited to every plenary debate that involves either foreign, security or defence policy. Rule 120 Breach of human rights At each part-session, the committees responsible may, without requiring authorisation, each table a motion for a resolution under the same procedure as that laid down in Rule 118(5) and (6) concerning cases of breaches of human rights. TITLE IV TRANSPARENCY OF BUSINESS Rule 121 Transparency of Parliament's activities 1. Parliament shall ensure that its activities are conducted with the utmost transparency, in accordance with the second paragraph of Article 1 of the Treaty on European Union, Article 15 of the Treaty on the Functioning of the European Union and Article 42 of the Charter of Fundamental Rights of the European Union. 2. Debates in Parliament shall be public. 3. Committees shall normally meet in public. At the latest when the agenda for a meeting is adopted, they may, however, decide to divide that agenda into items open to the public and items closed to the public. However, if a meeting is held in camera, the committee may decide to make documents from the meeting available for public access. Rule 122 Public access to documents 1. Any citizen of the Union and any natural or legal person residing or having its registered office in a Member State has a right of access to Parliament documents in accordance with Article 15 of the Treaty on the Functioning of the European Union. Such access to Parliament documents is subject to the principles, conditions and limits laid down in Regulation (EC) No 1049/2001. Access to Parliament documents shall as far as possible be granted to other natural or legal persons in the same way. 2. For the purpose of access to documents, the term ‘Parliament documents’ means any content within the meaning of Article 3(a) of Regulation (EC) No 1049/2001 which has been drawn up or received by officers of Parliament within the meaning of Title I, Chapter 2, of these Rules, by Parliament's governing bodies, committees or interparliamentary delegations, or by Parliament's Secretariat. In accordance with Article 4 of the Statute for Members of the European Parliament, documents drawn up by individual Members or political groups are Parliament documents for the purposes of access to documents only if they are tabled in accordance with the Rules of Procedure. The Bureau shall lay down rules to ensure that all Parliament documents are registered. 3. Parliament shall establish a public register website for Parliament documents. Legislative documents and certain other categories of documents shall, in accordance with Regulation (EC) No 1049/2001, be made directly accessible through Parliament's public register website. References to other Parliament documents shall, as far as possible, be included in Parliament's public register website. The categories of documents which are to be directly accessible through Parliament's public register website shall be set out in a list adopted by the Bureau and published on Parliament's public register website. That list shall not restrict the right of access to documents not falling within the categories listed; those documents may be made available on written application in accordance with Regulation (EC) No 1049/2001. The Bureau shall adopt rules for access to documents, pursuant to Regulation (EC) No 1049/2001, which shall be published in the Official Journal of the European Union 4. The Bureau shall designate the bodies responsible for the handling of initial applications (Article 7 of Regulation (EC) No 1049/2001) and for the adoption of decisions on confirmatory applications (Article 8 of that Regulation) and on applications for access to sensitive documents (Article 9 of that Regulation). 5. One of the Vice-Presidents shall be responsible for supervising the handling of applications for access to documents. 6. The Bureau shall adopt the annual report referred to in Article 17(1) of Regulation (EC) No 1049/2001. 7. Parliament's committee responsible shall regularly examine the transparency of Parliament's activities and shall submit a report with its conclusions and recommendations to the plenary. The committee responsible may also examine and evaluate the reports adopted by the other institutions and agencies in accordance with Article 17 of Regulation (EC) No 1049/2001. 8. The Conference of Presidents shall designate Parliament's representatives on the interinstitutional committee established pursuant to Article 15(2) of Regulation (EC) No 1049/2001. Rule 123 Access to Parliament 1. Access badges for Members, Members' assistants and third persons shall be issued on the basis of the rules laid down by the Bureau. Those rules shall also govern the use and withdrawal of access badges. 2. Badges shall not be issued to individuals within a Member's entourage who fall within the scope of the Agreement between the European Parliament and the European Commission on the transparency register. 3. Entities listed in the transparency register, and their representatives who have been issued with long-term access badges to the European Parliament must respect: — the Code of Conduct for Registrants annexed to the agreement, — the procedures and other obligations laid down by the agreement, and — the provisions implementing this Rule. Without prejudice to the applicability of the general rules governing the withdrawal or temporary de-activation of long-term access badges, and unless there are significant arguments to the contrary, the Secretary-General shall, with the authorisation of the Quaestors, withdraw or de- activate a long-term access badge where its holder has been disbarred from the transparency register for a breach of the Code of Conduct for Registrants, has been guilty of a serious breach of the obligations laid down in this paragraph, or has refused, without offering a sufficient justification, to comply with a formal summons to attend a hearing or committee meeting or to cooperate with a committee of inquiry. 4. The Quaestors may determine to what extent the Code of Conduct referred to in paragraph 3 is applicable to persons who, whilst in possession of a long-term access badge, do not fall within the scope of the agreement. 5. The Bureau, acting on a proposal from the Secretary-General, shall lay down the measures needed to implement the transparency register, in accordance with the provisions of the agreement on the establishment of that register. TITLE V RELATIONS WITH OTHER INSTITUTIONS AND BODIES CHAPTER 1 Appointments Rule 124 Election of the President of the Commission 1. When the European Council proposes a candidate for President of the Commission, the President shall request the candidate to make a statement and to present his or her political guidelines to Parliament. The statement shall be followed by a debate. The European Council shall be invited to take part in the debate. 2. In accordance with Article 17(7) of the Treaty on European Union, Parliament shall elect the President of the Commission by a majority of its component Members. The vote shall be taken by secret ballot. 3. If the candidate is elected, the President shall inform the Council accordingly, asking it and the President-elect of the Commission to propose, by common accord, the nominees for the various posts of Commissioners. 4. If the candidate does not obtain the required majority, the President shall invite the European Council to propose a new candidate within one month for election in accordance with the same procedure. Rule 125 Election of the Commission 1. The President shall invite the President-elect of the Commission to inform Parliament about the allocation of responsibilities (portfolios) in the proposed College of Commissioners in accordance with the political guidelines of the President-elect. 2. The President shall, after consulting the President-elect of the Commission, request the nominees proposed by the President-elect of the Commission and by the Council for the various posts of Commissioner to appear before the appropriate committees or bodies according to their prospective fields of responsibility. 3. The hearings shall be conducted by the committees. Exceptionally, a hearing may be carried out in a different format when the responsibilities of a Commissioner-designate are primarily horizontal in nature, provided that such a hearing involves the committees responsible. The hearings shall be held in public. 4. The appropriate committee or committees shall invite the Commissioner-designate to make a statement and to answer questions. The hearings shall be organised in such a way as to enable Commissioners-designate to disclose to Parliament all relevant information. Provisions relating to the organisation of such hearings shall be laid down in an annex to these Rules of Procedure (27). 5. The President-elect shall be invited to present the college of Commissioners and their programme at a sitting of Parliament. The President of the European Council and the President of the Council shall be invited to attend. The statement shall be followed by a debate. 6. In order to wind up that debate, a political group or Members reaching at least the low threshold may table a motion for a resolution. Rule 132(3) to (8) shall apply. 7. Following the vote on the motion for a resolution, Parliament shall elect or reject the Commission by a majority of the votes cast, by roll call. Parliament may defer the vote until the next sitting. 8. The President shall inform the Council of the election or rejection of the Commission. 9. In the event of a substantial portfolio change or a change in the composition of the Commission during the Commission's term of office, the Commissioners concerned or any other Commissioners designate shall be invited to participate in a hearing held in accordance with paragraphs 3 and 4. 10. In the event of a change in the Commissioner's portfolio or in the financial interests of a Commissioner during his or her term of office, this situation shall be subject to scrutiny by Parliament in accordance with Annex VII. If a conflict of interests is identified during a Commissioner's term of office and the President of the Commission fails to implement Parliament's recommendations for resolving that conflict of interests, Parliament may ask the President of the Commission to withdraw confidence in the Commissioner in question, pursuant to paragraph 5 of the Framework agreement on relations between the European Parliament and the European Commission and, where appropriate, to take action with a view to depriving the Commissioner in question of his or her right to a pension or other benefits in lieu of pension in accordance with the second paragraph of Article 245 of the Treaty on the Functioning of the European Union. Rule 126 Multiannual programming Upon the appointment of a new Commission, the Parliament, the Council and the Commission will, pursuant to paragraph 5 of the Interinstitutional Agreement on Better Law-Making, exchange views and agree on joint conclusions on multiannual programming. To that effect, and before negotiating with the Council and the Commission on the joint conclusions on multiannual programming, the President shall hold an exchange of views with the Conference of Presidents regarding the principal policy objectives and priorities for the new legislative term. This exchange of views will take into consideration, inter alia, the priorities presented by the President-elect of the Commission, as well as the replies given by Commissioners-designate during the hearings provided for in Rule 125. Before signing the joint conclusions, the President shall seek the approval of the Conference of Presidents. Rule 127 Motion of censure on the Commission 1. A motion of censure in respect of the Commission may be submitted to the President by one tenth of the component Members of Parliament. If a motion of censure has been voted on in the preceding two months, any new one tabled by less than one fifth of the component Members of Parliament shall be inadmissible. 2. The motion shall be called a ‘motion of censure’ and shall state reasons. It shall be forwarded to the Commission. 3. The President shall announce to Members that a motion of censure has been tabled immediately after he or she has received it. 4. The debate on censure shall not take place until at least 24 hours after the receipt of a motion of censure is announced to Members. 5. The vote on the motion shall be by roll call and shall not be taken until at least 48 hours after the beginning of the debate. 6. Without prejudice to paragraphs 4 and 5, the debate and the vote shall take place, at the latest, during the part-session following the submission of the motion. 7. In accordance with Article 234 of the Treaty on the Functioning of the European Union, the motion of censure shall be adopted if it secures a two-thirds majority of the votes cast, representing a majority of the component Members of Parliament. The President of the Council and the President of the Commission shall be notified of the result of the vote. Rule 128 Nomination of Judges and Advocates-General at the Court of Justice of the European Union On a proposal from the committee responsible, Parliament shall appoint its nominee to the panel of seven persons charged with scrutinising the suitability of candidates to hold the office of Judge or Advocate-General of the Court of Justice and the General Court. The committee responsible shall select the nominee that it wishes to propose by holding a vote by simple majority. For that purpose, the coordinators of that committee shall establish a shortlist of candidates. Rule 129 Appointment of the Members of the Court of Auditors 1. Candidates nominated as Members of the Court of Auditors shall be invited to make a statement before the committee responsible and to answer questions put by its members. The committee shall vote on each nomination separately by secret ballot. 2. The committee responsible shall make a recommendation to Parliament as to whether the nomination should be approved. 3. The vote in plenary shall take place within two months of receipt of the nomination unless Parliament, at the request of the committee responsible, a political group or Members reaching at least the low threshold, decides otherwise. Parliament shall vote on each nomination separately by secret ballot. 4. If the opinion, adopted by Parliament, on an individual nomination, is unfavourable, the President shall ask the Council to withdraw its nomination and to submit a new nomination to Parliament. Rule 130 Appointment of the Members of the Executive Board of the European Central Bank 1. The candidate nominated as President, Vice-President or Member of the Executive Board of the European Central Bank shall be invited to make a statement before the committee responsible and to answer questions put by its members. 2. The committee responsible shall make a recommendation to Parliament as to whether the nomination should be approved. 3. The vote shall take place within two months of receipt of the nomination unless Parliament, at the request of the committee responsible, a political group or Members reaching at least the low threshold, decides otherwise. Parliament shall vote on each nomination separately, by secret ballot. 4. If the opinion adopted by Parliament on a nomination is unfavourable, the President shall ask for the withdrawal of the nomination and for the submission to Parliament of a new nomination. Rule 131 Appointments to the economic governance bodies 1. This Rule shall apply to the appointment of: — the Chair and the Vice-Chair of the Supervisory Board of the European Central Bank, — the Chair, the Vice-Chair and the full-time members of the Single Resolution Board of the Single Resolution Mechanism, — the Chairs and Executive Directors of the European Supervisory Authority (European Banking Authority, European Securities and Markets Authority, European Insurance and Occupational Pensions Authority), and — the Managing Director and Deputy Managing Director of the European Fund for Strategic Investments. 2. Each candidate shall be invited to make a statement before the committee responsible and to answer questions put by its members. 3. The committee responsible shall make a recommendation to Parliament on each proposal for appointment. 4. The vote shall take place within two months of receipt of the proposal for appointment unless Parliament, at the request of the committee responsible, a political group or Members reaching at least the low threshold, decides otherwise. Parliament shall vote on each appointment separately, by secret ballot. 5. If the decision adopted by Parliament on a proposal for appointment is unfavourable, the President shall ask for its withdrawal and for the submission to Parliament of a new proposal. CHAPTER 2 Statements Rule 132 Statements by the Commission, Council and European Council 1. Members of the Commission, the Council and the European Council may, at any time, ask the President of Parliament for permission to make a statement. The President of the European Council shall make a statement after each of its meetings. The President of Parliament shall decide when the statement may be made and whether it is to be followed by a full debate or by a period of brief and concise questions from Members lasting 30 minutes. 2. When placing a statement with debate on its agenda, Parliament shall decide whether or not to wind up the debate with a resolution. It shall not do so if a report on the same matter is scheduled for the same or the next part-session, unless the President, for exceptional reasons, proposes otherwise. If Parliament decides to wind up a debate with a resolution, a committee, a political group or Members reaching at least the low threshold may table a motion for a resolution. 3. Motions for resolutions shall be put to the vote at the earliest possible voting time. The President shall decide on any exceptions. Explanations of vote shall be admissible. 4. A joint motion for a resolution shall replace the motions for resolutions tabled previously by its signatories, but not those tabled by other committees, political groups or Members. 5. If a joint motion for a resolution is tabled by political groups representing a clear majority, the President may put that motion to the vote first. 6. After a resolution has been adopted, no further motions may be put to the vote unless the President, in exceptional circumstances, decides otherwise. 7. The author or authors of a motion for a resolution tabled under paragraph 2 or Rule 144(2) shall be entitled to withdraw it before the final vote. 8. A motion for a resolution which has been withdrawn may be taken over and retabled immediately by a group, a committee or the same number of Members as is entitled to table it. This paragraph and paragraph 7 shall also apply to resolutions tabled under Rules 111 and 112. Rule 133 Statements explaining Commission decisions The President shall invite the President of the Commission, the Commissioner responsible for relations with the European Parliament or, by agreement, another Commissioner, to make a statement to Parliament, after each meeting of the Commission, explaining the main decisions taken, unless, for timetabling reasons or because of the relative political relevance of the subject- matter, the Conference of Presidents decides that this is not necessary. The statement shall be followed by a debate of at least 30 minutes in which Members may put brief and concise questions. Rule 134 Statements by the Court of Auditors 1. In the context of the discharge procedure or of Parliament's activities in the sphere of budgetary control, the President of the Court of Auditors may be invited to make a statement to Parliament in order to present the comments contained in the Annual Report, special reports or opinions of the Court, or in order to explain the Court's work programme. 2. Parliament may decide to hold a separate debate, with the participation of the Commission and the Council, on any questions raised in such statements in particular when irregularities in financial management have been reported. Rule 135 Statements by the European Central Bank 1. The President of the European Central Bank shall be invited to present to Parliament the Bank's Annual Report on the activities of the European System of Central Banks and on the monetary policy of both the previous and the current year. 2. This presentation shall be followed by a general debate. 3. The President of the European Central Bank shall be invited to attend meetings of the committee responsible at least four times a year in order to make a statement and to answer questions. 4. If they or Parliament so request, the President, Vice-President and other Members of the Executive Board of the European Central Bank shall be invited to attend additional meetings. 5. A verbatim report of the proceedings under paragraphs 3 and 4 shall be drawn up. CHAPTER 3 Parliamentary questions Rule 136 Questions for oral answer with debate 1. Questions to the Council, to the Commission or to the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy may be put by a committee, a political group or Members reaching at least the low threshold, accompanied with a request that they be placed on the agenda of Parliament. Such questions shall be submitted in writing to the President. The President shall immediately refer them to the Conference of Presidents. The Conference of Presidents shall decide whether or not to place those questions on the draft agenda in accordance with Rule 157. Questions not placed on Parliament's draft agenda within three months of being submitted shall lapse. 2. Questions to the Commission and to the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy shall be referred to the addressee at least one week before the sitting on the agenda of which they are to appear and questions to the Council at least three weeks before that date. 3. Where the questions concern the common security and defence policy, the time limits provided for in paragraph 2 shall not apply, and the reply must be given sufficiently promptly for Parliament to be kept properly informed. 4. A Member designated in advance by the questioners shall move the question in Parliament. If that Member is not present, the question shall lapse. The addressee shall answer. 5. Rule 132(2) to (8) concerning the tabling and voting of motions for resolutions shall apply mutatis mutandis. Rule 137 Question Time 1. Question Time with the Commission may be held at each part-session for a duration of up to 90 minutes on one or more specific horizontal themes to be decided upon by the Conference of Presidents one month in advance of the part-session. 2. The Commissioners invited to participate by the Conference of Presidents shall have a portfolio related to the specific horizontal theme or themes on which questions are to be put to them. The number of Commissioners to be invited shall be limited to two per part-session. However, it shall be possible to invite a third Commissioner, depending on the specific horizontal theme or themes chosen for the Question Time. 3. In accordance with guidelines established by the Conference of Presidents, specific question hours may be held with the Council, with the President of the Commission, with the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy and with the President of the Eurogroup. 4. Question time shall not be specifically allocated in advance. The President shall, as far as possible, ensure that Members that hold different political views and that come from different Member States are given the opportunity to put a question in turn. 5. The Member shall be given one minute in which to formulate the question and the Commissioner two minutes in which to reply. That Member may put a supplementary question, lasting no longer than 30 seconds and having a direct bearing on the main question. The Commissioner shall then be given two minutes in which to give a supplementary reply. Questions and supplementary questions must be directly related to the specific horizontal theme decided under paragraph 1. The President may rule on their admissibility. Rule 138 Questions for written answer 1. Any Member, a political group or a committee may put questions for written answer to the President of the European Council, to the Council, to the Commission or to the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy in accordance with criteria laid down in an annex to these Rules of Procedure (28). The content of questions shall be the sole responsibility of their authors. 2. Questions shall be submitted in electronic form to the President. Issues concerning the admissibility of a question shall be decided by the President. The President's decision shall not be based exclusively on the provisions of the annex referred to in paragraph 1 but on the provisions of these Rules of Procedure in general. The questioner shall be notified of the President's reasoned decision. 3. Each Member, political group or committee may submit a maximum of twenty questions over a rolling period of three months. As a general rule, the questions shall be answered by the addressee within six weeks of being forwarded to it. However, any Member, political group or committee may every month designate one of its questions as a ‘priority question’ to be answered by the addressee within three weeks of being forwarded to it. 4. A question may be supported by Members other than the author. Such questions shall only count towards the author's and not the supporter's maximum number of questions under paragraph 3. 5. If a question was not answered by the addressee within the deadline provided for in paragraph 3, the committee responsible may decide to place it on the agenda for its next meeting. 6. Questions, and answers, including their related annexes, thereto, shall be published on Parliament's website. Rule 139 Major interpellations for written answer 1. Major interpellations shall consist of questions for written answer put to the Council, the Commission or the Vice-President of the Commission/High-Representative of the Union for Foreign Affairs and Security Policy by a political group. 2. The major interpellation shall be of general interest and shall be submitted in writing to the President. It shall not exceed 500 words. Provided that the major interpellation is in accordance with the provisions of the Rules in general, the President shall immediately transmit it to the addressee for a written answer. 3. There shall be maximum 30 major interpellations every year. The Conference of Presidents shall ensure a fair distribution of such interpellations among the political groups, and no political group shall submit more than one per month. 4. If the addressee fails to answer the major interpellation within six weeks of being forwarded to it, the interpellation shall, at the request of the author, be placed on the final draft agenda of Parliament in accordance with the procedure provided for in Rule 157 and subject to paragraph 6. 5. On receipt of the written answer, if Members or a political group or groups reaching at least the medium threshold so request, the major interpellation shall be placed on the final draft agenda of Parliament in accordance with the procedure provided for in Rule 157 and subject to paragraph 6. 6. The number of major interpellations debated during the same part-session shall not exceed three. If debates are requested for more than three major interpellations during the same part-session, the Conference of Presidents shall include them in the final draft agenda in the order it has received those requests for debate. 7. A Member designated in advance by the author, or by those requesting the debate in accordance with paragraph 5, shall move the major interpellation in Parliament. If that Member is not present, the major interpellation shall lapse. The addressee shall answer. Rule 132(2) to (8) concerning the tabling of, and voting on, motions for resolutions shall apply mutatis mutandis. 8. Such interpellations, as well as the answers to them, shall be published on Parliament's website. Rule 140 Questions for written answer to the European Central Bank 1. Any Member may put a maximum of six questions for written answer per month to the European Central Bank in accordance with criteria laid down in an annex to these Rules of Procedure (29). The content of questions shall be the sole responsibility of their authors. 2. Such questions shall be submitted in writing to the Chair of the committee responsible. On receiving such questions, the Chair of the committee responsible shall notify them to the European Central Bank. Issues concerning the admissibility of a question shall be decided by the Chair of the committee responsible. The questioner shall be notified of any such decision. 3. Such questions, as well as the answers to them, shall be published on Parliament's website. 4. If a question for written answer has not received a reply within six weeks, it may, at the request of its author, be included on the agenda for the next meeting of the committee responsible with the President of the European Central Bank. Rule 141 Questions for written answer concerning the Single Supervisory Mechanism and the Single Resolution Mechanism 1. Rule 140 (1), (2) and (3) shall, with regard to questions for written answer concerning the Single Supervisory Mechanism and the Single Resolution Mechanism, apply mutatis mutandis. The number of such questions shall be subtracted from the maximum of six per month provided for in Rule 140(1). 2. If a question for written answer has not received a reply within five weeks, it may, at the request of its author, be included on the agenda for the next meeting of the committee responsible with the Chair of the Board of the addressee. CHAPTER 4 Reports of other institutions and bodies Rule 142 Annual and other reports of other institutions or bodies 1. Annual and other reports of other institutions or bodies in respect of which the Treaties provide for consultation of Parliament, or in respect of which other legal provisions require an opinion by Parliament, shall be dealt with in a report submitted to the plenary. 2. Annual and other reports of other institutions or bodies not covered by paragraph 1 shall be referred to the committee responsible, which shall examine them, and which may submit a short motion for resolution to Parliament or propose the drawing up of a report under Rule 54 if it considers that Parliament should take a position on an important matter covered in the reports. CHAPTER 5 Resolutions and recommendations Rule 143 Motions for resolutions 1. Any Member may table a motion for a resolution on a matter falling within the spheres of activity of the European Union. That motion may not be more than 200 words long. 2. Such a motion may not: — contain any decision on matters for which other specific procedures and competences are laid down in these Rules of Procedure, in particular Rule 47, or — deal with the subject of ongoing proceedings in Parliament. 3. Each Member may table no more than one such motion per month. 4. The motion for a resolution shall be submitted to the President, who shall verify whether it fulfils the applicable criteria. If the President declares the motion to be admissible, he or she shall announce it in plenary and refer it to the committee responsible. 5. The committee responsible shall decide what procedure is to be followed, which may include the combination of the motion for a resolution with other motions for a resolution or with reports; the adoption of an opinion, which may take the form of a letter; or the drawing up of a report under Rule 54. The committee responsible may also decide not to follow up the motion for a resolution. 6. The authors of a motion for a resolution shall be informed of the decisions of the President, of the committee and of the Conference of Presidents. 7. The report referred to in paragraph 5 shall contain the text of the motion for a resolution. 8. Opinions in the form of a letter referred to in paragraph 5 that are addressed to other institutions of the European Union shall be forwarded to them by the President. 9. A motion for a resolution tabled in accordance with paragraph 1 may be withdrawn by its author or authors or by its first signatory before the committee responsible has decided, in accordance with paragraph 5, to draw up a report on it. Once that motion for a resolution has been thus taken over by the committee responsible, only that committee shall have the power to withdraw it. The committee responsible shall retain that power of withdrawal until the opening of the final vote in plenary. Rule 144 Debates on cases of breaches of human rights, democracy and the rule of law 1. A committee, an interparliamentary delegation, a political group or Members reaching at least the low threshold may ask the President in writing for a debate to be held on an urgent case of a breach of human rights, democracy and the rule of law. 2. The Conference of Presidents shall draw up a list of subjects to be included in the final draft agenda for the next debate on cases of breaches of human rights, democracy and the rule of law on the basis of the requests referred to in paragraph 1 and in accordance with the provisions of Annex IV. The total number of subjects included in the agenda shall not exceed three, including sub-chapters. In accordance with Rule 158, Parliament may abandon a topic due to be debated and replace it with an unscheduled topic. Motions for resolutions on the subjects chosen may be tabled by a committee, a political group or Members reaching at least the low threshold by the evening of the day on which the agenda is adopted. The President shall set the precise deadline for tabling such motions for resolutions. 3. The total speaking time for the political groups and non-attached Members shall be allocated in accordance with the procedure laid down in Rule 171(4) and (5), up to a maximum time for debates of 60 minutes per part-session. Any time remaining after the time required to introduce the motions for resolutions and any speaking time allocated to the Commission and Council has been deducted shall be divided among the political groups and the non-attached Members. 4. At the end of the debate there shall be an immediate vote. Rule 194, concerning explanations of vote, shall not apply. Votes taken under this Rule may be organised on a collective basis under the responsibility of the President and the Conference of Presidents. 5. If two or more motions for resolutions are tabled on the same subject, the procedure set out in Rule 132(4) and (5) shall apply. 6. The President and the Chairs of the political groups may decide that a motion for a resolution is to be put to the vote without debate. Such a decision shall require the unanimous agreement of all the Chairs of the political groups. The provisions of Rules 197 and 198 do not apply to motions for resolutions included on the agenda for a debate on cases of breaches of human rights, democracy and the rule of law. Motions for resolutions are tabled for a debate on cases of breaches of human rights, democracy and the rule of law only after the list of subjects has been adopted. Motions for resolutions that cannot be dealt with in the time allocated for the debate lapse. The same applies to motions for resolutions for which it is established, following a request under Rule 178(3), that a quorum is not present. The authors are entitled to retable such motions either for consideration in committee under Rule 143 or for the debate on cases of breaches of human rights, democracy and the rule of law at the next part-session. A subject may not be included on the agenda for a debate on cases of breaches of human rights, democracy and the rule of law if it is already on the agenda for that part-session. There are no provisions in the Rules to allow a joint debate on a motion for a resolution, tabled in accordance with the second subparagraph of paragraph 2, and a committee report on the same subject. When a request is made under Rule 178(3) to establish whether a quorum is present, that request shall be valid only for the motion for a resolution which is to be put to the vote and not for those which follow. CHAPTER 6 Consultation of other institutions and bodies Rule 145 Consultation of the European Economic and Social Committee 1. Where the Treaty on the Functioning of the European Union provides for the consultation of the Economic and Social Committee, the President shall initiate the consultation procedure and inform Parliament thereof. 2. A committee may request that the European Economic and Social Committee be consulted on matters of a general nature or on specific points. The committee shall indicate, in its request, the deadline for delivery by the European Economic and Social Committee of its opinion. A request for consultation of the European Economic and Social Committee shall be announced to Parliament at its next part-session and shall be deemed to have been approved, unless, within 24 hours from the announcement, a political group or Members reaching at least the low threshold request that it be put to the vote. 3. Opinions forwarded by the Economic and Social Committee shall be referred to the committee responsible. Rule 146 Consultation of the Committee of the Regions 1. Where the Treaty on the Functioning of the European Union provides for the consultation of the Committee of the Regions, the President shall initiate the consultation procedure and inform Parliament thereof. 2. A committee may request that the Committee of the Regions be consulted on matters of a general nature or on specific points. The committee shall indicate, in its request, the deadline for delivery by the Committee of the Regions of its opinion. A request for consultation of the Committee of the Regions shall be announced to Parliament at its next part-session and shall be deemed to have been approved, unless within 24 hours from the announcement a political group or Members reaching at least the low threshold request that it be put to the vote. 3. Opinions forwarded by the Committee of the Regions shall be referred to the committee responsible. Rule 147 Requests to European Agencies 1. Where Parliament has the right to submit a request to a European Agency, any Member may submit that request in writing to the President of Parliament. Such requests shall be on matters that fall within the remit of the Agency concerned and shall be accompanied by background information explaining the issue and the Union interest. 2. The President shall, after consulting the committee responsible, either forward the request to the Agency or take any other appropriate course of action. The Member submitting the request shall be notified immediately. Any request sent by the President to an Agency shall include a time-limit for response. 3. If the Agency considers itself to be unable to respond to the request as formulated, or seeks to have it modified, it shall forthwith inform the President, who shall take any appropriate course of action, after consulting the committee responsible if necessary. CHAPTER 7 Interinstitutional agreements Rule 148 Interinstitutional agreements 1. Parliament may enter into agreements with other institutions in the context of the application of the Treaties, or in order to improve or clarify procedures. Such agreements may take the form of joint declarations, exchanges of letters, codes of conduct or other appropriate instruments. After they have been examined by the committee responsible for constitutional affairs and approved by Parliament, they shall be signed by the President. 2. Where such agreements necessitate changes to existing procedural rights or obligations, establish new procedural rights or obligations for Members or bodies of Parliament, or otherwise necessitate amendment or interpretation of the Rules of Procedure, the matter shall be referred to the committee responsible for the subject matter for its consideration in accordance with Rule 236(2) to (6) before the agreement is signed. CHAPTER 8 Referrals to the Court of Justice of the European Union Rule 149 Proceedings before the Court of Justice of the European Union 1. Parliament shall, within the time limits specified, by the Treaties and the Statute of the Court of Justice of the European Union, for action by the institutions of the Union and by natural or legal persons, examine Union legislation and its implementation in order to ensure that the Treaties have been fully complied with, in particular where Parliament's rights are concerned. 2. If it suspects a breach of Union law, the committee responsible for legal affairs shall report to Parliament, orally if necessary. Where appropriate, the committee responsible for legal affairs may hear the views of the committee responsible for the subject matter. 3. The President shall bring an action on behalf of Parliament in accordance with the recommendation of the committee responsible for legal affairs. At the start of the following part-session, the President may ask Parliament to decide whether the action should be maintained. If Parliament rules against the action by a majority of the votes cast, the President shall withdraw the action. If the President brings an action contrary to the recommendation of the committee responsible for legal affairs, he or she shall, at the start of the following part-session, ask Parliament to decide whether the action should be maintained. 4. The President shall, after consulting the committee responsible for legal affairs, submit observations or intervene in court proceedings on behalf of Parliament. If the President intends to depart from the recommendation of the committee responsible for legal affairs, he or she shall inform the committee accordingly and shall refer the matter to the Conference of Presidents, stating his or her reasons. If the Conference of Presidents takes the view that Parliament should, exceptionally, not submit observations or intervene in a case before the Court of Justice of the European Union in which the legal validity of an act of Parliament is being questioned, the matter shall be submitted to Parliament without delay. Nothing in the Rules prevents the committee responsible for legal affairs from deciding on appropriate procedural arrangements for the timely transmission of its recommendation in urgent cases. Where it is necessary to take a decision as to whether Parliament should exercise its rights vis-à-vis the Court of Justice of the European Union, and the act in question is not covered by Rule 149 of these Rules of Procedure, the procedure provided for in this rule should apply mutatis mutandis. 5. In urgent cases, the President may, after consulting, where possible, the Chair and the rapporteur of the committee responsible for legal affairs, take precautionary action in order to comply with the relevant time-limits. In such cases, the procedures provided for in paragraphs 3 or 4 shall, as applicable, be implemented at the earliest opportunity. 6. The committee responsible for legal affairs shall lay down the principles that it will use in its application of this Rule. TITLE VI RELATIONS WITH NATIONAL PARLIAMENTS Rule 150 Exchange of information, contacts and reciprocal facilities 1. Parliament shall keep the national parliaments of the Member States regularly informed of its activities. 2. The organisation and promotion of effective and regular interparliamentary cooperation within the Union, pursuant to Article 9 of the Protocol No 1 on the role of national parliaments in the European Union, shall be negotiated on the basis of a mandate given by the Conference of Presidents, after consulting the Conference of Committee Chairs. Parliament shall approve any agreements on such matters in accordance with the procedure set out in Rule 148. 3. A committee may directly engage in dialogue with national parliaments at committee level within the limits of the budgetary appropriations set aside for that purpose. This may include appropriate forms of pre-legislative and post-legislative cooperation. 4. Any document concerning a legislative procedure at Union level that is officially transmitted by a national parliament to the European Parliament shall be forwarded to the committee responsible for the subject-matter dealt with in that document. 5. The Conference of Presidents may give a mandate to the President to negotiate facilities for the national parliaments of the Member States, on a reciprocal basis, and to propose any other measures to facilitate contacts with those national parliaments. Rule 151 Conference of Parliamentary Committees for Union Affairs (COSAC) 1. On a proposal from the President, the Conference of Presidents shall name the members of, and may grant a mandate to, Parliament's delegation to COSAC. The delegation shall be headed by a Vice-President of the European Parliament who is responsible for the implementation of relations with the national parliaments and by the Chair of the committee responsible for constitutional affairs. 2. The other members of the delegation shall be chosen in the light of the subjects to be discussed at the COSAC meeting and shall include, as far as possible, representatives of the committees responsible for those subjects. 3. When choosing members of the delegation, due account shall be taken of the overall political balance within Parliament. 4. The delegation shall, after each COSAC meeting, submit a report to the Conference of Presidents. Rule 152 Conferences of parliaments The Conference of Presidents shall designate the members of Parliament's delegation to any conference or similar body attended by representatives of parliaments and shall grant a mandate to that delegation that conforms to any relevant Parliament resolutions. The delegation shall elect its Chair and, where appropriate, one or more Vice-Chairs. TITLE VII SESSIONS CHAPTER 1 Sessions of Parliament Rule 153 Parliamentary term, sessions, part-sessions, sittings 1. The parliamentary term shall run concurrently with the term of office of Members provided for in the Act of 20 September 1976. 2. The session shall be the annual period prescribed by the Act and the Treaties. 3. The part-session shall be the meeting of Parliament convened as a rule each month and subdivided into daily sittings. Sittings of Parliament held on the same day shall be deemed to be a single sitting. Rule 154 Convening of Parliament 1. In accordance with the first paragraph of Article 229 of the Treaty on the Functioning of the European Union, Parliament shall meet, without requiring to be convened, on the second Tuesday in March each year. It shall itself determine the duration of adjournments of the session. 2. In addition, Parliament shall meet, without requiring to be convened, on the first Tuesday after expiry of an interval of one month from the end of the period referred to in Article 10(1) of the Act of 20 September 1976. 3. The Conference of Presidents, stating its reasons, may alter the duration of the adjournments decided pursuant to paragraph 1 at least two weeks before the date previously fixed by Parliament for resuming the session. The resumption of the session shall not, however, be postponed by more than two weeks. 4. At the request of a majority of its component Members or at the request of the Commission or the Council, the President shall, after consulting the Conference of Presidents, convene Parliament on an exceptional basis. The President shall have the right, with the approval of the Conference of Presidents, to convene Parliament on an exceptional basis in cases of urgency. Rule 155 Venue of sittings and meetings 1. Parliament shall hold its sittings and its committee meetings in accordance with the provisions of the Treaties. Proposals for additional part-sessions in Brussels and any amendments thereto will require only a majority of the votes cast. 2. Any committee may decide to request that one or more meetings be held elsewhere. Such a request, which shall be supported by reasons, shall be made to the President, who shall place it before the Bureau. If the matter is urgent, the President may take the decision himself or herself. If the request is rejected by the Bureau or the President, the reasons for the rejection shall be stated. Rule 156 Attendance of Members at sittings 1. An attendance register shall be open for signature by Members at each sitting. 2. The names of the Members recorded as being present in the attendance register shall be indicated in the minutes of each sitting as ‘present’. The names of the Members excused by the President shall be indicated in the minutes of each sitting as ‘excused’. CHAPTER 2 Order of business of Parliament Rule 157 Draft agenda 1. Before each part-session the draft agenda shall be drawn up by the Conference of Presidents on the basis of recommendations by the Conference of Committee Chairs. The Commission and the Council may, at the invitation of the President, attend the deliberations of the Conference of Presidents on the draft agenda. 2. The draft agenda may indicate voting times for certain items down for consideration. 3. The final draft agenda shall be made available to Members at least three hours before the beginning of the part-session. Rule 158 Adopting and amending the agenda 1. At the beginning of each part-session, Parliament shall adopt its agenda. Amendments to the final draft agenda may be proposed by a committee, a political group or Members reaching at least the low threshold. Any such proposals must be received by the President at least one hour before the opening of the part-session. The President may give the floor to the mover and to one speaker against, and in each case for not more than one minute. 2. Once adopted, the agenda may not be amended, except pursuant to Rules 163, 197, 198, 199, 200 or 201, or on a proposal from the President. If a procedural motion to amend the agenda is rejected, it may not be tabled again during the same part-session. The drafting or amendment of the title of a resolution tabled to wind up a debate under Rules 132, 136 or 144 does not constitute a change to the agenda, provided that the title remains within the scope of the subject being debated. 3. Before closing the sitting, the President shall announce the date, time and agenda of the next sitting. Rule 159 Procedure in plenary without amendment and debate 1. Where a report was adopted in committee with fewer than one tenth of the members of the committee voting against, it shall be placed on the draft agenda of Parliament for vote without amendment. The item shall then be subject to a single vote unless, before the drawing up of the final draft agenda, Members or a political group or groups reaching at least the medium threshold have requested in writing that the item be open to amendment, in which case the President shall set a deadline for tabling amendments. 2. Items placed on the final draft agenda for vote without amendment shall also be put to the vote without debate unless Parliament, when adopting its agenda at the start of a part-session, decides otherwise on a proposal from the Conference of Presidents or at the request of a political group or Members reaching at least the low threshold. 3. When drawing up the final draft agenda for a part-session, the Conference of Presidents may propose that other items be put to the vote without amendment or without debate. When adopting its agenda, Parliament may not accept any such proposal if a political group or Members reaching at least the low threshold have tabled their opposition in writing at least one hour before the opening of the part-session. 4. When an item is put to the vote without debate, the rapporteur or the Chair of the committee responsible may, immediately prior to the vote, make a statement, which shall last no more than two minutes. Rule 160 Short presentation At the request of the rapporteur or on a proposal from the Conference of Presidents, Parliament may also decide that an item that does not need a full debate will be dealt with by means of a short presentation in plenary by the rapporteur. In that event, the Commission shall have the opportunity to respond, followed by up to ten minutes of debate in which the President may give the floor, for up to one minute each, to Members who catch his or her eye. Rule 161 Extraordinary debate 1. A political group or Members reaching at least the low threshold may request that an extraordinary debate on a matter of major interest relating to European Union policy be placed on Parliament's agenda. As a rule, no more than one extraordinary debate shall be held during each part-session. 2. The request shall be submitted to the President in writing at least three hours before the start of the part-session at which the extraordinary debate is to take place. The vote on this request shall be taken at the start of the part-session when Parliament adopts its agenda. 3. In response to events that take place after the adoption of the agenda for a part-session, the President, after consulting the Chairs of the political groups, may propose an extraordinary debate. Any such proposal shall be voted on at the start of a sitting or at a scheduled voting time. Members shall be notified of any such proposal for an extraordinary debate at least one hour before the vote. 4. The President shall determine the time at which such a debate is to be held. The overall duration of the debate shall not exceed 60 minutes. Speaking time shall be allocated to the political groups and the non-attached Members in accordance with Rule 171(4) and (5). 5. The debate shall be wound up without the adoption of a resolution. Rule 162 Topical debate requested by a political group 1. At each part-session, one or two periods of at least 60 minutes each shall be set aside in the draft agenda for debates on a topical matter of major interest for European Union policy. 2. Each political group shall have the right to propose a topical matter of its choice for at least one such debate per year. The Conference of Presidents shall ensure, over a rolling period of one year, a fair distribution among the political groups of the exercise of that right. 3. The political groups shall transmit the topical matter of their choice to the President in writing before the drawing up of the final draft agenda by the Conference of Presidents. Rule 39(1) concerning the rights, freedoms and principles recognised by Article 6 of the Treaty on European Union and the values enshrined in its Article 2 shall be fully respected. 4. The Conference of Presidents shall determine the time at which such a debate is to be held. It may, by a majority representing four-fifths of the Parliament Members, decide to reject a matter put forward by a group. 5. The debate shall be introduced by a representative of the political group having proposed the topical matter. Speaking time following this introduction shall be allocated in accordance with Rule 171 (4) and (5). 6. The debate shall be wound up without the adoption of a resolution. Rule 163 Urgent procedure 1. A request to treat a debate on a proposal submitted to Parliament pursuant to Rule 48(1) as urgent may be made to Parliament by the President, a committee, a political group, Members reaching at least the low threshold, the Commission or the Council. Such requests shall be made in writing and supported by reasons. 2. As soon as the President has received a request for urgent debate this shall be announced in Parliament. The vote on the request shall be taken at the beginning of the sitting following that during which the announcement was made, provided that the proposal to which the request relates has been distributed to Members in the official languages. Where there are several requests for urgent debate on the same subject, the approval or rejection of the request for urgent debate shall apply to all such requests that are on the same subject. 3. Before the vote, only the mover, and one speaker against may be heard, along with the Chair or rapporteur of the committee responsible, or both. None of those speakers may speak for more than three minutes. 4. Questions to be dealt with by urgent procedure shall be given priority over other items on the agenda. The President shall determine the time of the debate and vote. 5. An urgent procedure may be held without a report or, exceptionally, on the basis of an oral report by the committee responsible. Where an urgent procedure is used and interinstitutional negotiations take place, Rules 70 and 71 shall not apply. Rule 74 shall apply mutatis mutandis. Rule 164 Joint debate A decision may be taken at any time for similar or factually related items of business to be debated jointly. Rule 165 Time limits Except in the cases of urgency referred to in Rules 144 and 163, a debate and vote shall not be held on a text unless it has been made available to Members at least 24 hours earlier. CHAPTER 3 General rules for the conduct of sittings Rule 166 Access to the Chamber 1. No person may enter the Chamber except Members of Parliament, Members of the Commission or Council, the Secretary-General of Parliament, members of staff whose duties require them to be there, and any person invited by the President. 2. Only holders of an admission card duly issued by the President or Secretary-General of Parliament shall be admitted to the galleries. 3. Members of the public admitted to the galleries shall remain seated and keep silent. Any person expressing approval or disapproval shall immediately be removed by the ushers. Rule 167 Languages 1. All documents of Parliament shall be drawn up in the official languages. 2. All Members shall have the right to speak in Parliament in the official language of their choice. Speeches delivered in one of the official languages shall be simultaneously interpreted into the other official languages and into any other language that the Bureau may consider to be necessary. 3. Interpretation shall be provided in committee and delegation meetings from and into the official languages that are used and requested by the members and substitutes of that committee or delegation. 4. At committee and delegation meetings away from the usual places of work, interpretation shall be provided from and into the languages of those members who have confirmed that they will attend the meeting. These arrangements may exceptionally be made more flexible. The Bureau shall adopt the necessary provisions. 5. After the result of a vote has been announced, the President shall rule on any requests concerning alleged discrepancies between the different language versions. Rule 168 Transitional arrangement 1. During a transitional period expiring at the end of the ninth parliamentary term (30), derogations from Rule 167 shall be permissible if and to the extent that, despite adequate precautions having been taken, interpreters or translators for an official language are not available in sufficient numbers. 2. The Bureau, on a proposal from the Secretary-General and having due regard to the arrangements referred to in paragraph 3, shall ascertain with respect to each of the official languages concerned whether the conditions set out in paragraph 1 are fulfilled. The Bureau shall, on the basis of a progress report from the Secretary-General, review its decision to permit a derogation at six-monthly intervals. The Bureau shall adopt the necessary implementing rules. 3. The temporary special arrangements adopted by the Council on the basis of the Treaties concerning the drafting of legal acts shall apply. 4. Parliament may, on the basis of a reasoned recommendation from the Bureau, decide at any time to repeal this Rule early or, at the end of the period indicated in paragraph 1, to extend it. Rule 169 Distribution of documents The documents that form the basis for Parliament's debates and decisions shall be made available to Members. Without prejudice to the first paragraph, Members and political groups shall have direct access to the European Parliament's internal computer system for the purpose of consulting any non-confidential preparatory document (draft report, draft recommendation, draft opinion, working document, amendments tabled in committee). Rule 170 Electronic handling of documents Parliament documents may be prepared, signed and distributed in electronic form. The Bureau shall decide on the technical specifications, and on the presentation, of the electronic form. Rule 171 Allocation of speaking time and list of speakers (31) 1. The Conference of Presidents may propose to Parliament that speaking time be allocated for a particular debate. Parliament shall decide on this proposal without debate. 2. Members may not speak unless called upon to do so by the President. Members shall speak from their places and shall address the President. If speakers depart from the subject matter of the debate, the President shall call them to order. 3. The President may draw up, for the first part of a particular debate, a list of speakers that includes one or more rounds of speakers from each political group wishing to speak, in the order of the relative size of those political groups. 4. Speaking time for this part of a debate shall be allocated in accordance with the following criteria: (a) a first fraction of speaking time shall be divided equally among all the political groups; (b) a second fraction shall be divided among the political groups in proportion to the total number of their members; (c) the non-attached Members shall be allocated an overall speaking time based on the fractions allocated to each political group under points (a) and (b); (d) the allocation of speaking time in the plenary shall take into consideration the fact that Members with disabilities might need more time. 5. Where a total speaking time is allocated for several items on the agenda, the political groups shall inform the President of the fractions of their speaking time to be used for each individual item. The President shall ensure that these speaking times are respected. 6. The remaining part of the time for a debate shall not be specifically allocated in advance. Instead, the President may call on Members to speak, as a general rule for no more than one minute. The President shall, as far as possible, ensure that speakers who hold different political views and who come from different Member States are heard in turn. 7. On request, the President may give priority to the Chair and to the rapporteur of the committee responsible, as well as to those Chairs of political groups who wish to speak on their groups' behalf, or to speakers who are deputising for them. 8. The President may give the floor to Members who indicate, by raising a blue card, their wish to put to another Member, during that Member's speech, a question of no longer than half a minute's duration related to what that Member has said. The President shall only do so if the speaker agrees to the question and if the President is satisfied that this will lead neither to disruption of the debate nor, through the putting of successive questions by raising a blue card, to a gross imbalance in the political group affinities of Members speaking in that debate. 9. No Member may speak for more than one minute on any of the following subject matters: the minutes of the sitting, procedural motions, or amendments to the final draft agenda or the agenda. 10. In the debate on a report, the Commission and the Council shall, as a rule, be heard immediately after the presentation, by the rapporteur, of his or her report. The Commission, the Council and the rapporteur may be heard again, in particular in order to respond to the statements made by Members. 11. Members who have not spoken in a debate may, no more than once per part-session, hand in a written statement of not more than 200 words, which shall be appended to the verbatim report of the debate. 12. Having due regard to Article 230 of the Treaty on the Functioning of the European Union, the President shall seek to reach an understanding with the Commission, the Council and the President of the European Council on an appropriate allocation to them of speaking time. Rule 172 One-minute speeches For a period of not more than 30 minutes during the first sitting of each part-session, the President shall call Members who wish to draw Parliament's attention to a matter of political importance to speak. Speaking time for each Member shall not exceed one minute. The President may allow a further such period later during the same part-session. Rule 173 Personal statements 1. Members who ask to make a personal statement shall be heard at the end of the discussion of the agenda item which is being dealt with, or when the minutes of the sitting to which the request for leave to speak refers are considered for approval. The Members concerned may not speak on substantive matters but shall confine their observations to rebutting any remarks that have been made concerning their person in the course of the debate or opinions that have been attributed to them, or correcting observations that they themselves have made. 2. Unless Parliament decides otherwise, no personal statement shall last for more than three minutes. Rule 174 Prevention of obstruction (32) The President shall have the power to put an end to the excessive use of motions such as points of order, procedural motions or explanations of vote, or of requests for separate, split or roll-call votes, where he or she is convinced that those motions or requests are manifestly intended to cause, and would result in, a prolonged and serious obstruction of the procedures of Parliament or the rights of the Members. CHAPTER 4 Measures to be taken in the event of non-compliance with the standards of conduct of members Rule 175 Immediate measures 1. The President shall call to order any Member who breaches the standards of conduct defined in Rule 10 (3) or (4). 2. If the breach is repeated, the President shall call the Member to order a second time, and the fact shall be recorded in the minutes. 3. If the breach continues, or if a further breach is committed, the Member may be denied the right to speak and may be excluded from the Chamber by the President for the remainder of the sitting. In cases of exceptional seriousness, the President may also resort to exclusion of the Member concerned from the Chamber for the remainder of the sitting immediately and without a second call to order. The Secretary-General shall, without delay, see to it that such disciplinary measures are carried out, with the assistance of the ushers and, if necessary, of Parliament's Security Service. 4. Should disturbances threaten to obstruct the business of the House, the President shall close or suspend the sitting for a specific period in order to restore order. If the President cannot make himself or herself heard, he or she shall leave the chair; this shall have the effect of suspending the sitting. The President shall reconvene the sitting. 5. The President may decide to interrupt the live broadcasting of the sitting in the case of a breach of Rule 10 (3) or (4) by a Member. 6. The President may order the deletion from the audiovisual record of the proceedings of those parts of a speech by a Member that breach Rule 10 (3) or (4). That order shall take immediate effect. It shall, however, be subject to confirmation by the Bureau not later than four weeks thereafter, or, if the Bureau does not meet during that period, at its next meeting. 7. The powers provided for in paragraphs 1 to 6 shall be vested, mutatis mutandis, in the presiding officers of bodies, committees and delegations as provided for in the Rules of Procedure. 8. Where appropriate, and bearing in mind the seriousness of the breach of the standards of conduct of Members, the Member in the chair of a part-session, body, committee or delegation may, no later than the following part-session or the following meeting of the body, committee or delegation concerned, ask the President to apply Rule 176. Rule 176 Penalties 1. In serious cases of breach of Rule 10 (2) to (9), the President shall adopt a reasoned decision imposing upon the Member concerned the appropriate penalty in accordance with this Rule. In relation to Rule 10 (3) or (4), the President may adopt a reasoned decision under this Rule regardless of whether or not an immediate measure within the meaning of Rule 175 had previously been imposed upon the Member concerned. In relation to Rule 10 (6), the President may only adopt a reasoned decision under this Rule following the establishment of the occurrence of a harassment in accordance with the applicable internal administrative procedure on harassment and its prevention. The President may impose a penalty upon a Member in cases in which provision is made, by these Rules of Procedure or by a decision adopted by the Bureau under Rule 25, for the application of this Rule. 2. The Member concerned shall be invited by the President to submit written observations before the decision is adopted. The President may decide to convene an oral hearing instead whenever it is more appropriate. The decision imposing the penalty shall be notified to the Member concerned by registered letter or, in urgent cases, via the ushers. After that decision has been notified to the Member concerned, any penalty imposed on a Member shall be announced by the President in Parliament. The presiding officers of the bodies, committees and delegations on which the Member serves shall be informed. Once the penalty becomes final, it shall be published prominently on Parliament's website, and shall remain there for the rest of the parliamentary term. 3. When assessing the conduct observed, account shall be taken of its exceptional, recurrent or permanent nature and of its seriousness. Account shall also be taken, if applicable, of possible damage inflicted on the dignity and reputation of Parliament. 4. The penalty may consist of one or more of the following measures: (a) a reprimand; (b) forfeiture of entitlement to the daily subsistence allowance for a period of between two and thirty days; (c) without prejudice to the right to vote in plenary, and subject, in this instance, to strict compliance with the Members' standards of conduct, temporary suspension from participation in all or some of the activities of Parliament for a period of between two and thirty days on which Parliament or any of its bodies, committees or delegations meet; (d) prohibition of the Member from representing the Parliament on an inter-parliamentary delegation, inter-parliamentary conference or any interinstitutional forum, for up to one year; (e) in the case of a breach of confidentiality, a limitation in the rights to access confidential or classified information for up to one year. 5. The measures laid down in points (b) to (e) of paragraph 4 may be doubled in the case of repeated breaches, or if the Member refuses to comply with a measure taken under Rule 175(3). 6. In addition, the President may submit a proposal to the Conference of Presidents for the suspension or removal of the Member from one or more of the offices held by that Member in Parliament, in accordance with the procedure laid down in Rule 21. Rule 177 Internal appeal procedures The Member concerned may lodge an internal appeal with the Bureau within two weeks of notification of the penalty imposed by the President by virtue of Rule 176(1) to (5). Such an appeal shall have the effect of suspending the application of that penalty. The Bureau may, not later than four weeks after the lodging of the appeal or, if it does not meet in that period, at its next meeting, annul, confirm or modify the penalty imposed, without prejudice to the external rights of appeal open to the Member concerned. If the Bureau fails to take a decision within the time limit laid down, the penalty shall be deemed to be null and void. CHAPTER 5 Quorum, amendments and voting Rule 178 Quorum 1. Parliament may deliberate, settle its agenda and approve its minutes, irrespective of the number of Members present. 2. A quorum shall exist when one third of the component Members of Parliament are present in the Chamber. 3. All votes shall be valid whatever the number of Members voting unless the President, on a request made by at least 40 Members before voting began, establishes that a quorum is not present. If the number of Members required to make up a quorum is not present, the President shall declare that a quorum is not present, and the vote shall be placed on the agenda for the next sitting. The electronic voting system may be used in order to check the threshold of 40 Members, but it may not be used for checking the quorum. The doors of the Chamber may not be closed. 4. Members who ask for the quorum to be established must be present in the Chamber when the request is made, and shall be counted as being present within the meaning of paragraphs 2 and 3, even if they then leave the Chamber. 5. If fewer than 40 Members are present, the President may rule that there is no quorum. Rule 179 Thresholds (33) 1. For the purposes of these Rules, and unless specified otherwise, the following definitions shall apply: (a) ‘low threshold’ means one-twentieth of Parliament's component Members or a political group; (b) ‘medium threshold’ means one-tenth of Parliament's component Members, made up of one or more political groups or individual Members, or a combination of the two; (c) ‘high threshold’ means one-fifth of Parliament's component Members made up of one or more political groups or individual Members, or a combination of the two. 2. Where, for the purpose of determining whether an applicable threshold has been reached, a Member's signature is required, that signature may be either handwritten or in electronic form, in which case it shall be produced by the electronic signature system of Parliament. Within the relevant time-limits, a Member may withdraw, but may not subsequently renew, his or her signature. 3. Where the support of a political group is necessary in order for a threshold to be reached, the group shall act through its Chair or through a person duly designated by him or her for that purpose. 4. For the application of the medium and high thresholds, the support of a political group shall be counted as follows: — where a Rule laying down such a threshold is invoked in the course of a sitting or meeting: all Members who belong to the supporting group and are physically present, — in all other cases: all Members who belong to the supporting group. Rule 180 Tabling and presenting amendments (34) 1. Amendments for consideration in Parliament may be tabled by the committee responsible, a political group or Members reaching at least the low threshold. The names of all co-signatories shall be published. Amendments shall be tabled in writing and signed by their authors. Amendments to proposals for legally binding acts may be accompanied by a short justification. Such justifications shall be the responsibility of the author and shall not be put to the vote. 2. Subject to the limitations laid down in Rule 181, an amendment may seek to change any part of a text. It may be directed to deleting, adding or replacing words or figures. In this Rule and Rule 181, the term ‘text’ means the whole of a motion for a resolution/draft legislative resolution, of a proposal for a decision or of a proposal for a legally binding act. 3. The President shall set a deadline for the tabling of amendments. 4. An amendment may be presented during the debate by its author or by any other Member appointed by the author to replace him or her. 5. Where an amendment is withdrawn by its author, it shall fall unless it is immediately taken over by another Member. 6. Amendments shall be put to the vote only after they have been made available in all the official languages, unless Parliament decides otherwise. Parliament may not decide otherwise if at least 40 Members object. Parliament shall avoid taking decisions which would place Members who use a particular language at an unacceptable disadvantage. Where fewer than 100 Members are present, Parliament may not decide otherwise if at least one tenth of the Members present object. On a proposal from the President, an oral amendment, or any other oral modification, shall be treated in the same way as an amendment not made available in all the official languages. If the President considers that it is admissible under Rule 181(2), and save in the case of objection under Rule 180(6), it shall be put to the vote in accordance with the order of voting established. In committee, the number of votes needed to object to such an amendment or such a modification is established on the basis of Rule 219 proportionally to that applicable in plenary, rounded up, where necessary, to the nearest complete number. Rule 181 Admissibility of amendments (35) 1. Without prejudice to the additional conditions laid down in Rule 54(4) concerning own initiative reports and Rule 68(2) concerning amendments to the Council's position, no amendment shall be admissible if: (a) it does not directly relate to the text which it seeks to amend; (b) it seeks to delete or replace the whole of a text; (c) it seeks to amend more than one of the individual articles or paragraphs of the text to which it relates with the exception of compromise amendments and amendments which seek to make identical changes to a particular form of words throughout the text; (d) it seeks to amend a proposal for codification of Union legislation; however, the second subparagraph of Rule 109(3) shall apply mutatis mutandis; (e) it seeks to amend those parts of a proposal recasting Union legislation which remain unchanged in such proposal; however, the second subparagraph of Rule 110(2) and the third subparagraph of Rule 110(3) shall apply mutatis mutandis; (f) it only seeks to ensure the linguistic correctness, or address the terminological consistency, of the text in the language in which the amendment is tabled; in this case, the President shall seek a suitable linguistic remedy together with those concerned. 2. The President shall decide whether amendments are admissible. The President's decision under paragraph 2 concerning the admissibility of amendments is not based exclusively on the provisions of paragraph 1 of this Rule but on the provisions of the Rules in general. 3. A political group or Members reaching at least the low threshold may table an alternative motion for a resolution seeking to replace a motion for a non-legislative resolution contained in a committee report. In such a case, the group or the Members concerned may not table amendments to the motion for a resolution by the committee responsible. The alternative motion for a resolution may not be longer than the committee's motion for a resolution. It shall be put to a single vote in Parliament without amendment. Rule 132(4) and (5) concerning joint motions for resolutions shall apply mutatis mutandis. 4. With the agreement of the President, amendments may, exceptionally, be tabled after the close of the deadline for amendments if they are compromise amendments, or if there are technical problems. The President shall decide on the admissibility of such amendments. The President shall obtain the agreement of Parliament to do so before putting such amendments to the vote. The following general criteria for admissibility of compromise amendments may be applied: — as a general rule, the compromise amendments relate to parts of the text which have been the subject of amendments prior to the deadline for tabling amendments, — as a general rule, the compromise amendments are tabled by political groups representing a majority in Parliament, the Chairs or rapporteurs of the committees concerned or the authors of other amendments, — as a general rule, the compromise amendments entail the withdrawal of other amendments to the same passage. Only the President may propose that a compromise amendment be considered. In order for a compromise amendment to be put to the vote, the President must obtain the agreement of Parliament by asking whether there are any objections to such a vote being held. If an objection is raised, Parliament shall decide on the matter by a majority of the votes cast. Rule 182 Voting procedure (36) 1. Save where these Rules specifically provide otherwise, the following voting procedure shall apply to texts submitted to Parliament: (a) first, where applicable, voting any amendment to the proposal for a legally binding act; (b) second, where applicable, voting on that proposal as a whole, amended or otherwise; If the proposal for a legally binding act, as amended or otherwise, does not secure a majority of the votes cast in committee, then the committee shall propose to Parliament that the proposal be rejected. (c) third, voting on any amendment to the motion for a resolution/draft legislative resolution; (d) finally, voting on the motion for a resolution as a whole (final vote). Parliament shall not vote on any explanatory statement contained in a report. 2. In voting on proposals for legally binding acts and on motions for non-legislative resolutions, votes relating to substantive parts shall be taken first, followed by votes relating to citations and recitals. 3. An amendment shall fall if it is inconsistent with decisions previously taken on the text during the same vote. 4. The only Member permitted to speak during the vote shall be the rapporteur, or, in his or her place, the Chair of the committee. He or she shall have the opportunity of expressing briefly the views of the committee responsible on the amendments put to the vote. Rule 183 Order of voting on amendments (37) 1. Amendments shall have priority over the text to which they relate and shall be put to the vote before that text. 2. If two or more mutually exclusive amendments have been tabled to the same part of a text, the amendment that departs furthest from the original text shall have priority and shall be put to the vote first. If it is adopted, the other amendments shall be deemed to have been rejected; if it is rejected, the amendment next in priority shall be put to the vote, and this procedure shall be repeated for each of the remaining amendments. Where there is a doubt as to priority, the President shall decide. If all amendments are rejected, the original text shall be deemed to have been adopted unless a separate vote has been requested within the deadline specified. 3. However, where the President considers that this will facilitate the vote, he or she may put the original text to the vote first, or put an amendment that is closer to the original text to the vote before the amendment that departs furthest from the original text. If either of these secures a majority, all other amendments tabled to the same part of the text shall fall. 4. Where compromise amendments are put to the vote, they shall be given priority in voting. 5. A split vote shall not be admissible in the case of a vote on a compromise amendment. 6. Where the committee responsible has tabled a set of amendments to the text with which the report is concerned, the President shall put them to the vote collectively, unless on particular points a political group or Members reaching at least the low threshold have requested separate or split votes or unless other competing amendments have been tabled. 7. The President may put other amendments to the vote collectively where they are complementary, unless a political group or Members reaching at least the low threshold have requested separate or split votes. Authors of amendments may also propose collective votes on their amendments. 8. The President may decide, following the adoption or rejection of a particular amendment, that several other amendments of similar content or with similar objectives shall be put to the vote collectively. The President may seek the agreement of Parliament before doing so. Such a set of amendments may relate to different parts of the original text. 9. Where two or more identical amendments are tabled by different authors, they shall be put to the vote as one. 10. Amendments in respect of which a roll-call vote has been requested shall be put to the vote separately from other amendments. Rule 184 Committee filter of plenary amendments When more than 50 amendments or requests for a split or separate vote have been tabled concerning a text tabled by a committee for consideration in Parliament, the President may, after consulting its Chair, ask that committee to meet to vote on each of those amendments or requests. Any amendment or request for a split or separate vote that does not receive votes in favour at this stage from at least one-third of the members of the committee shall not be put to the vote in Parliament. Rule 185 Split voting (38) 1. Where the text to be put to the vote contains two or more provisions or references to two or more points, or lends itself to division into two or more parts that have a distinct meaning and/or normative value, a split vote may be requested by a political group or Members reaching at least the low threshold. 2. The request shall be made at the latest on the evening before the vote, unless the President sets a different deadline. The President shall decide on the request. Rule 186 Right to vote (39) The right to vote is a personal right. Members shall cast their votes individually and in person. Any infringement of this Rule is considered a serious breach of Rule 10(3). Rule 187 Voting (40) 1. As a general rule, Parliament shall vote by show of hands. However, the President may, at any time, decide that the voting operations will be carried out by means of the electronic voting system. 2. The President shall declare votes open and closed. Once the President has declared a vote open, no-one except the President shall be allowed to speak until the vote is declared to be closed. 3. In calculating whether a text has been adopted or rejected, account shall be taken only of votes cast for and against, except in those cases for which the Treaties lay down a specific majority. 4. If the President decides that the result of a vote by show of hands is doubtful, a fresh vote shall be taken using the electronic voting system and, if the latter is not working, by sitting and standing. 5. The President shall establish the result of the vote and announce it. 6. The result of the vote shall be recorded. Rule 188 Final vote When deciding on the basis of a report, Parliament shall take any single and/or final vote by roll call in accordance with Rule 190(3). The provisions of Rule 188 on voting by roll call do not apply to the reports provided for in Rule 8(2) and Rule 9(4), (7) and (9) in the context of procedures relating to the immunity of a Member. Rule 189 Tied votes (41) 1. In the event of a tied vote under Rule 182(1)(b) or (d), the text as a whole shall be referred back to committee. This shall also apply to votes under Rules 3 and 9. 2. In the event of a tied vote on a text put to a split vote under Rule 185, the text shall be deemed to have been adopted. 3. In all other cases where there is a tied vote, without prejudice to those Rules which require qualified majorities, the text or proposal shall be deemed to have been rejected. Rule 189(3) is to be interpreted as meaning that, where there is a tied vote on a draft recommendation under Rule 149(4) not to intervene in proceedings before the Court of Justice of the European Union, such a tie does not signify the adoption of a recommendation according to which Parliament should intervene in those proceedings. In such a case, the committee responsible is to be deemed not to have expressed any recommendation. The President may vote, but shall not have a casting vote. Rule 190 Voting by roll call (42) 1. In addition to the cases provided for in these Rules, the vote shall be taken by roll call if this is requested in writing by a political group or Members reaching at least the low threshold at the latest the evening before the vote unless the President sets a different deadline. The provisions of Rule 190 on voting by roll call do not apply to the reports provided for in Rule 8(2) and Rule 9(4), (7) and (9) in the context of procedures relating to the immunity of a Member. 2. Each political group may table no more than one hundred requests for roll call votes per part-session. 3. The roll call vote shall be taken using the electronic voting system. Where the latter cannot be used for technical reasons, the roll may be called in alphabetical order, beginning with the name of a Member drawn by lot. The President shall be the last to be called to vote. Voting shall be oral and shall be expressed by saying the words ‘Yes’, ‘No’, or ‘I abstain’. 4. Votes shall be recorded in the minutes of the sitting by political group in the alphabetical order of Members' names, with an indication of how they voted. Rule 191 Voting by secret ballot (43) 1. In the case of appointments, voting shall be by secret ballot without prejudice to Rules 15(1) and 213(2), first subparagraph. Only ballot papers bearing the names of candidates who have been nominated shall be taken into account in calculating the number of votes cast. 2. Voting shall also be by secret ballot if this is requested by Members or a political group or groups reaching at least the high threshold. Such requests must be made before voting begins. 3. A request for a secret ballot shall take priority over a request for a vote by roll call. 4. Between two and eight Members chosen by lot shall count the votes cast in a secret ballot, unless an electronic vote is taken. In the case of votes under paragraph 1, candidates shall not act as tellers. The names of Members who have taken part in a secret ballot shall be recorded in the minutes of the sitting at which the ballot was held. Rule 192 Use of electronic voting system (44) 1. The technical arrangements for using the electronic voting system shall be governed by instructions from the Bureau. 2. Where an electronic vote is taken, unless it concerns a roll call vote, only the numerical result of the vote shall be recorded. 3. The President may at any time decide to use the electronic voting system in order to check a threshold. Rule 193 Disputes on voting (45) 1. Points of order concerning the validity of a vote may be raised after the President has declared that vote to be closed. 2. After the result of a vote by show of hands has been announced, a Member may request that that result be checked using the electronic voting system. 3. The President shall decide whether the result announced is valid. His or her decision shall be final. Rule 194 Explanations of votes 1. Once the voting session has been concluded, any Member may give an oral explanation on the single and/or final vote on an item submitted to Parliament for not longer than one minute. Each Member may give a maximum of three oral explanations of vote per part-session. Any Member may, on such vote, hand in a written explanation of vote of no more than 200 words which shall be included on the Member's page on Parliament's website. Any political group may give an explanation of vote lasting not more than two minutes. No further requests to give explanations of votes shall be accepted once the first explanation of vote on the first item has begun. Explanations of votes are admissible on the single and/or final vote on any item submitted to Parliament. For the purposes of this Rule, the term ‘final vote’ does not refer to the type of vote, but means the last vote on any item. 2. Explanations of votes shall not be admissible in the case of secret ballot or votes on procedural matters. 3. Where an item has been included on the agenda of Parliament without amendments or without debate, Members may only submit written explanations of votes in accordance with paragraph 1. Explanations of votes given either orally or in writing must have a direct bearing on the item submitted to Parliament. CHAPTER 6 Points of order and procedural motions Rule 195 Points of order (46) 1. Members may be allowed to speak in order to draw the attention of the President to any failure to comply with Parliament's Rules of Procedure. They shall first specify to which Rule they are referring. 2. A request to raise a point of order shall take precedence over all other requests to speak or procedural motions. 3. Speaking time shall not exceed one minute. 4. The President shall take an immediate decision on points of order in accordance with the Rules of Procedure and shall announce it immediately after the point of order has been raised. No vote shall be taken concerning the President's decision. 5. Exceptionally, the President may state that he or she will announce the decision later, but the President shall not do so more than 24 hours after the point of order was raised. Postponement of the ruling shall not entail the adjournment of the debate. The President may refer the matter to the committee responsible. A request to raise a point of order must relate to the agenda item under discussion. The President may take a point of order concerning a different matter at an appropriate time, e.g. after the discussion of the agenda item in question is closed or before the sitting is suspended. Rule 196 Procedural motions 1. Requests to move a procedural motion, namely: (a) the inadmissibility of a matter (Rule 197); (b) referral back to committee (Rule 198); (c) the closure of a debate (Rule 199); (d) the adjournment of a debate or vote (Rule 200); or (e) the suspension or closure of the sitting (Rule 201); shall take precedence over other requests to speak. In addition to the mover, only the following Members shall be heard on these motions: one speaker against and the Chair or rapporteur of the committee responsible. 2. The speaking time shall not exceed one minute. Rule 197 Motions calling for a matter to be declared inadmissible 1. At the beginning of the debate on a specific item on the agenda, a political group or Members reaching at least the low threshold may present a motion calling for it to be declared inadmissible. Such a motion shall be put to the vote immediately. The intention to present an inadmissibility motion shall be notified at least 24 hours in advance to the President who shall inform Parliament immediately. 2. If the motion is carried, Parliament shall immediately proceed to the next item on the agenda. Rule 198 Referral back to committee 1. Referral back to committee may be requested by a political group or Members reaching at least the low threshold when the agenda is fixed or before the start of the debate. The intention to present a motion calling for referral back to committee shall be notified at least 24 hours in advance to the President, who shall inform Parliament immediately. 2. A motion calling for referral back to committee may also be presented by a political group or Members reaching at least the low threshold before or during a vote. Such a motion shall be put to the vote immediately. 3. Such a motion may be made only once at each of the procedural stages referred to in paragraphs 1 and 2. 4. Referral back to committee shall entail suspension of the consideration of the item. 5. Parliament may set a time limit for the committee to report its conclusions. Rule 199 Closure of a debate 1. A debate may, on a proposal from the President or at the request of a political group or Members reaching at least the low threshold, be closed before the list of speakers has been exhausted. Such a proposal or request shall be put to the vote immediately. 2. If the proposal or request is carried, one Member only may speak from each political group which has not yet provided a speaker in that debate. 3. After the speeches referred to in paragraph 2, the debate shall be closed and Parliament shall vote on the matter under debate, except where the time for the vote has been set in advance. 4. If the proposal or request is rejected, it may not be tabled again during the same debate, except by the President. Rule 200 Adjournment of a debate or vote (47) 1. At the start of a debate on an item on the agenda, a political group or Members reaching at least the low threshold may move that the debate be adjourned to a specific date and time. Such a motion shall be put to the vote immediately. The intention to move adjournment shall be notified to the President at least 24 hours in advance. The President shall immediately inform Parliament of any notification. 2. If the motion is carried, Parliament shall proceed to the next item on the agenda. The adjourned debate shall be resumed at the specified date and time. 3. If the motion is rejected, it may not be tabled again during the same part-session. 4. Before or during a vote, a political group or Members reaching at least the low threshold may present a motion calling for the vote to be adjourned. Such a motion shall be put to the vote immediately. Rule 201 Suspension or closure of the sitting (48) The sitting may be suspended or closed during a debate or a vote if Parliament so decides on a proposal from the President or at the request of Members or a political group or groups reaching at least the high threshold. Such a proposal or request shall be put to the vote immediately. If a request to suspend or close the sitting is presented, the procedure to vote on that request is to be initiated without undue delay. The usual means of announcing plenary votes should be used and, in accordance with existing practice, sufficient time should be given for Members to reach the Chamber. By analogy with the second subparagraph of Rule 158(2), if such a request has been rejected, a similar request cannot be tabled again during the same day. In accordance with Rule 174, the President has the right to put an end to excessive use of requests presented under this Rule. CHAPTER 7 Public record of proceedings Rule 202 Minutes 1. The minutes of each sitting, detailing the proceedings, the names of speakers and the decisions of Parliament, including the result of any vote on any amendment, shall be made available at least half an hour before the beginning of the afternoon period of the next sitting. 2. A list of documents forming the basis for Parliament's debates and decisions shall be published in the minutes. 3. At the beginning of the afternoon period of each sitting, the President shall place before Parliament, for its approval, the minutes of the previous sitting. 4. If any objections to the minutes are raised, Parliament shall, if necessary, decide whether the changes requested should be taken into account. No Member may speak on the subject for more than one minute. 5. The minutes shall be signed by the President and the Secretary-General and preserved in the records of Parliament. They shall be published in the Official Journal of the European Union. Rule 203 Texts adopted 1. Texts adopted by Parliament shall be published immediately after the vote. They shall be placed before Parliament in conjunction with the minutes of the relevant sitting and preserved in the records of Parliament. 2. Texts adopted by Parliament shall be subject to legal-linguistic finalisation, under the responsibility of the President. Where such texts are adopted on the basis of an agreement reached between Parliament and the Council, such finalisation shall be carried out by those two institutions, acting in close cooperation and by mutual agreement. 3. The procedure laid down in Rule 241 shall apply where, in order to ensure the coherence and quality of the text in accordance with the will expressed by Parliament, adaptations are required which go beyond corrections of typographical errors or corrections necessary to ensure the concordance of all language versions, their linguistic correctness and their terminological consistency. 4. Positions adopted by Parliament under the ordinary legislative procedure shall take the form of a consolidated text. Where the vote in Parliament is not based on an agreement with the Council, the consolidated text shall identify any amendments that were adopted. 5. After finalisation, the texts adopted shall be signed by the President and the Secretary-General and published in the Official Journal of the European Union. Rule 204 Verbatim reports (49) 1. A verbatim report of the proceedings of each sitting shall be drawn up as a multilingual document in which all oral contributions appear in the original official language. 2. Without prejudice to his or her other disciplinary powers, the President may cause to be deleted from the verbatim reports the speeches of Members who have not been called upon to speak or who continue to speak beyond the time allotted to them. 3. Speakers may make corrections to typescripts of their oral contributions within five working days. Corrections shall be sent within that deadline to the Secretariat. 4. The multilingual verbatim report shall be published as an annex to the Official Journal of the European Union and preserved in the records of Parliament. 5. A translation into any official language of an extract from the verbatim report shall be made if it is requested by a Member. If necessary, the translation shall be provided at short notice. Rule 205 Audiovisual record of proceedings 1. The proceedings of Parliament in the languages in which they are conducted, as well as the multilingual soundtrack from all active interpretation booths, shall be broadcast in real time on its website. 2. Immediately after the sitting, an indexed audiovisual record of the proceedings in the languages in which they were conducted, as well as the multilingual soundtrack from all active interpretation booths, shall be produced and made available on Parliament's website for the remainder of the parliamentary term and during the following parliamentary term, after which it shall be preserved in the records of Parliament. That audiovisual record shall be linked to the multilingual verbatim reports of the proceedings as soon as they are available. TITLE VIII COMMITTEES AND DELEGATIONS CHAPTER 1 Committees Rule 206 Setting-up of standing committees Parliament shall, on a proposal from the Conference of Presidents, set up standing committees. Their responsibilities shall be defined in an annex to these Rules of Procedure (50). That annex shall be adopted by a majority of the votes cast. Their members shall be appointed during the first part-session following the re-election of Parliament. The responsibilities of standing committees can also be redefined at a time other than that at which the committee is set up. Rule 207 Special committees 1. On a proposal from the Conference of Presidents, Parliament may, at any time, set up special committees, the responsibilities, numerical strength and term of office of which shall be defined at the same time as the decision to set them up is taken. 2. The term of office of special committees may not exceed 12 months except where Parliament extends that period before its expiry. Unless otherwise decided in Parliament's decision setting up the special committee, its term of office shall start running from the date of its constitutive meeting. 3. Special committees shall not have the right to deliver opinions to other committees. Rule 208 Committees of inquiry 1. In accordance with Article 226 of the Treaty on the Functioning of the European Union and Article 2 of Decision 95/167/EC, Euratom, ECSC of the European Parliament, the Council and the Commission (51), Parliament may, at the request of one quarter of its component Members, set up a committee of inquiry to investigate alleged contraventions or maladministration in implementation of Union law which would appear to be the act of an institution or body of the European Union, of a public administrative body of a Member State, or of persons empowered by Union law to implement that law. The subject of the inquiry, as defined by one quarter of Parliament's component Members, and the period laid down in paragraph 11 shall not be open to amendments. 2. The decision to set up a committee of inquiry shall be published in the Official Journal of the European Union within one month of being taken. 3. The modus operandi of a committee of inquiry shall be governed by the provisions of the Rules relating to committees, save as otherwise specifically provided for in this Rule and in Decision 95/167/EC, Euratom, ECSC. 4. The request to set up a committee of inquiry must precisely specify the subject of the inquiry and include a detailed statement of the grounds for it. Parliament, on a proposal from the Conference of Presidents, shall decide whether to set up a committee and, if so, its numerical strength. 5. Committees of inquiry shall not have the right to deliver opinions to other committees. 6. At any stage of its proceedings, only full members or, in their absence, substitutes may vote in a committee of inquiry. 7. A committee of inquiry shall elect its Chair and Vice-Chairs and appoint one or more rapporteurs. The committee may also assign responsibilities, duties or specific tasks to its members who must subsequently report to the committee in detail thereon. 8. In the interval between one meeting and another, the coordinators of the committee shall, in cases of urgency or need, exercise the committee's powers, subject to ratification by that committee at its next meeting. 9. With regard to the languages used, a committee of inquiry shall apply the provisions of Rule 167. However, the bureau of the committee: — may restrict interpretation to the official languages of those members of the committee taking part in the deliberations, if it deems this to be necessary for reasons of confidentiality, — shall decide about the translation of the documents received in such a way as to ensure that the committee can carry out its deliberations efficiently and rapidly, as well as to ensure that the necessary secrecy and confidentiality are respected. 10. Where alleged contraventions or maladministration in the implementation of Union law suggest that a body or authority of a Member State could be responsible, the committee of inquiry may ask the parliament of the Member State concerned to cooperate in the investigation. 11. A committee of inquiry shall conclude its work by presenting to Parliament a report on the results of its work within no more than 12 months from its constitutive meeting. Parliament may twice decide to extend this period by three months. The report may, if appropriate, contain minority positions in accordance with the conditions laid down in Rule 55. The report shall be published. At the request of the committee of inquiry, Parliament shall hold a debate on the report at the part- session following its submission. 12. The committee may also submit to Parliament a draft recommendation addressed to institutions or bodies of the European Union or to the Member States. 13. The President shall instruct the committee responsible under Annex VI to monitor the action taken on the results of the work of the committee of inquiry and, if appropriate, to report thereon. The President shall take any further steps which are deemed to be appropriate in order to ensure that the conclusions of the inquiry are acted upon in practice. Rule 209 Composition of committees 1. Members of committees, special committees and committees of inquiry shall be appointed by the political groups and the non-attached Members. The Conference of Presidents shall set a deadline by which political groups and the non-attached Members are to communicate their appointments to the President, who shall then announce them to Parliament. 2. The composition of the committees shall, as far as possible, reflect the composition of Parliament. The distribution of committee seats among political groups must be either the nearest whole number above or the nearest whole number below the proportional calculation. Where there is no agreement among the political groups on their proportional weight within one or more specific committees, the Conference of Presidents shall decide. 3. If a political group decides not to take seats on a committee, or fails to appoint its members within the deadline set by the Conference of Presidents, the seats in question shall remain vacant. Exchange of seats between political groups is not allowed. 4. Where a Member's change of political group has the effect of disturbing the proportional distribution of committee seats as defined in paragraph 2, and there is no agreement among political groups to ensure compliance with the principles set out therein, the Conference of Presidents shall take the necessary decisions. 5. Any modifications decided to the appointments by political groups and non-attached Members shall be communicated to the President, who shall announce them to Parliament at the latest at the beginning of the next sitting. These decisions shall take effect from the day of the announcement. 6. The political groups and the non-attached Members may appoint a number of substitutes for each committee which shall not exceed the number of full members that the political group or the non-attached Members are entitled to appoint in the committee. The President shall be informed accordingly. These substitutes shall be entitled to attend and to speak at committee meetings and, if the full member is absent, to take part in the vote. 7. In the absence of the full member and where substitutes either have not been appointed or are absent, the full member may arrange to be represented at meetings by another member of the same political group, or, where the member is a non-attached Member, by another non-attached Member, who shall be entitled to vote. The Chair of the committee shall be notified at the latest by the beginning of the voting session. The advance notification provided for in the last sentence of paragraph 7 must be given before the end of the debate or before the opening of the vote on the item or items for which the full member is to be replaced. In accordance with this Rule: — the status of a full or substitute member of a committee shall depend exclusively on membership of a given political group, — if the number of a political group's full members in a committee changes, the maximum number of permanent substitutes which it can appoint to that committee shall change accordingly, — Members who change their political group may not keep the status of full or substitute member of a committee which they had as members of their original group, — a committee member may not under any circumstances be a substitute for a colleague who belongs to another political group. Rule 210 Duties of committees 1. Standing committees shall examine questions referred to them by Parliament or, during an adjournment of the session, the President on behalf of the Conference of Presidents. 2. Should two or more standing committees be competent to deal with a question, one committee shall be named as the committee responsible and the others as committees asked for opinions. A question shall not, however, be referred simultaneously to more than three committees, unless it is decided to depart from this rule under the conditions laid down in paragraph 1. 3. Any two or more committees or subcommittees may jointly consider matters falling within their competence, but they may not take a decision jointly, except where Rule 58 applies. 4. Any committee may, with the agreement of Parliament's relevant bodies, instruct one or more of its members to undertake a study or fact-finding mission. Rule 211 Questions of competence 1. If a standing committee declares itself not to be competent to consider an item, or if a conflict arises over the competence of two or more standing committees, the question of competence shall be submitted to the Conference of Committee Chairs within four weeks of the announcement in Parliament of the referral to committee. 2. The Conference of Presidents shall take a decision within six weeks after the submission of the question on the basis of a recommendation from the Conference of Committee Chairs, or, if no such recommendation is forthcoming, from the latter's Chair. If the Conference of Presidents fails to take a decision within that period, the recommendation shall be deemed to have been approved. 3. The committee Chairs may enter into agreements with other committee Chairs concerning the allocation of an item to a particular committee, subject, where necessary, to the authorisation of an associated committee procedure under Rule 57. Rule 212 Subcommittees 1. Subcommittees may be set up in accordance with Rule 206. A standing or special committee may also, in the interests of its work and subject to prior authorisation by the Conference of Presidents, appoint one or more subcommittees, at the same time determining their composition, in accordance with the relevant provisions laid down in Rule 209, as well as their areas of responsibility, which must fall within the areas of responsibility of the parent committee. Subcommittees shall report to their parent committee. 2. Unless otherwise specified in these Rules, the procedure for subcommittees shall be the same as for committees. 3. Full members of a subcommittee shall be chosen from among the members of the parent committee. 4. Substitutes shall be allowed to sit on subcommittees under the same conditions as on committees. 5. The Chair of the parent committee may involve the Chairs of the subcommittees in the work of the coordinators or may allow them to chair debates in the parent committee on issues specifically dealt with by the subcommittees in question, provided that this way of proceeding is submitted to the committee bureau for its consideration and approved. Rule 213 Committee bureaux 1. At the first committee meeting after the appointment of committee members pursuant to Rule 209, and again two and a half years thereafter, the committee shall elect a bureau consisting of a Chair and of Vice-Chairs from among its full members in separate ballots. The number of Vice-Chairs to be elected shall be determined by Parliament upon a proposal by the Conference of Presidents. The diversity of Parliament must be reflected in the composition of the bureau of each committee; it shall not be permissible to have an all male or all female bureau or for all of the Vice-Chairs to come from the same Member State. 2. Where the number of nominations corresponds to the number of seats to be filled, the election shall take place by acclamation. However, if there is more than one candidate on a given ballot, or members or a political group or groups reaching at least the high threshold in the committee requested a vote, the election shall take place by secret ballot. If there is only one candidate, the election shall be by an absolute majority of the votes cast, for and against. If there is more than one candidate, the candidate who obtains an absolute majority of the votes cast at the first ballot shall be elected. At the second ballot, the candidate who obtains the highest number of votes shall be elected. In the event of a tie, the oldest candidate shall be elected. 3. The following Rules concerning the Officers of Parliament shall apply mutatis mutandis to committees: Rule 14 (Provisional Chair), Rule 15 (Nominations and general provisions), Rule 16 (Election of President — opening address), Rule 19 (Term of office of Officers) and Rule 20 (Vacancies). Rule 214 Committee coordinators 1. The political groups may designate one of their members in each committee to be a coordinator. 2. A meeting of the committee coordinators shall if necessary be convened by the committee Chair to prepare decisions to be taken by the committee, in particular decisions on procedure and on the appointment of rapporteurs. The committee may delegate the power to take certain decisions to the coordinators, with the exception of decisions concerning the adoption of reports, motions for resolutions, opinions or amendments. The Vice-Chairs may be invited to participate in the meetings of committee coordinators in a consultative role. When consensus cannot be attained, the coordinators may only act by a majority that clearly represents a large majority of the committee, having regard to the respective strengths of the various political groups. The Chair shall announce in committee all decisions and recommendations of the coordinators, which shall be deemed to have been adopted if they have not been contested. They shall be duly mentioned in the minutes of the committee meeting. Non-attached Members do not constitute a political group within the meaning of Rule 33 and they cannot therefore designate coordinators, who are the only Members entitled to attend coordinator meetings. In all cases, non-attached Members must be guaranteed access to information, in accordance with the principle of non-discrimination, through the supply of information and the presence of a member of the non-attached Members' secretariat at coordinator meetings. Rule 215 Shadow Rapporteurs The political groups may designate a shadow rapporteur for each report to follow the progress of the relevant report and find compromises within the committee on behalf of the group. Their names shall be communicated to the committee Chair. Rule 216 Committee meetings 1. A committee shall meet when convened by its Chair or at the request of the President. When convening the meeting, the Chair shall submit a draft agenda. The committee shall take a decision on the agenda at the beginning of the meeting. 2. The Commission, the Council and other Union institutions may take the floor in committee meetings if invited to do so on behalf of a committee by its Chair. By decision of a committee, any other person may be invited to attend and to take the floor at a meeting. The committee responsible may, subject to approval by the Bureau, organise a hearing of experts if it considers such a hearing to be essential for the effective conduct of its work on a particular subject. 3. Without prejudice to Rule 56(8) and unless the committee concerned decides otherwise, Members who attend meetings of committees to which they do not belong, may not take part in their deliberations. They may, however, be allowed by the committee to take part in its meetings in an advisory capacity. 4. Rule 171(2) on allocation of speaking time shall apply mutatis mutandis to committees. 5. Where a verbatim report is drawn up, Rule 204 (2), (3) and (5) shall apply mutatis mutandis. Rule 217 Minutes of committee meetings The minutes of each meeting of a committee shall be made available to all its members and submitted to the committee for its approval. Rule 218 Voting in committee 1. Without prejudice to Rule 65(3) on second readings, amendments or draft proposals for rejection tabled for consideration in committee shall always be signed by a full or substitute member of the committee concerned or co-signed by at least one such member. 2. A committee may validly vote when one quarter of its members are actually present. However, if so requested by members or a political group or groups reaching at least the high threshold in the committee before voting begins, the vote shall be valid only if the majority of its members have taken part in it. 3. Any single and/or final vote in committee on a report or opinion shall be taken by roll call in accordance with Rule 190(3) and (4). The vote on amendments and other votes shall be taken by a show of hands, unless the Chair decides to proceed to an electronic vote or members or a political group or groups reaching at least the high threshold in the committee request a vote by roll call. The provisions of Rule 218(3) on voting by roll call do not apply to the reports provided for in Rule 8(2) and Rule 9(4), (7) and (9) in the context of procedures relating to the immunity of a Member. 4. In the light of the amendments tabled, the committee may, instead of proceeding to a vote, ask the rapporteur to submit a new draft taking account of as many of the amendments as possible. A new deadline shall then be set for amendments. Rule 219 Provisions concerning plenary sittings applicable in committee The following Rules concerning voting, points of order and procedural motions shall apply mutatis mutandis to committees: Rule 174 (Prevention of obstruction), Rule 179 (Thresholds), Rule 180 (Tabling and presenting amendments), Rule 181 (Admissibility of amendments), Rule 182 (Voting procedure), Rule 183 (Order of voting on amendments), Rule 185(1) (Split voting), Rule 186 (Right to vote), Rule 187 (Voting), Rule 189 (Tied votes), Rule 190(3) and (4) (Voting by roll call), Rule 191 (Voting by secret ballot), Rule 192 (Use of electronic voting system), Rule 193 (Disputes on voting), Rule 195 (Points of order), Rule 200 (Adjournment of a debate or vote) and Rule 201 (Suspension or closure of the sitting). Rule 220 Question Time in committee Question Time may be held in committee if a committee so decides. Each committee shall decide on its own rules for the conduct of Question Time. Rule 221 Procedure for the consultation by a committee of confidential information in a committee meeting in camera 1. When Parliament is under a legal obligation to treat information received as confidential information, the Chair of the committee responsible shall automatically apply the confidential procedure laid down in paragraph 3. 2. Without prejudice to paragraph 1, in the absence of any legal obligation to treat the information received as confidential information, any committee may apply the confidential procedure laid down in paragraph 3 on its own motion to an item of information or a document indicated by one of its members in a written or oral request. A majority of two-thirds of the members present shall be required for the adoption of a decision to apply the confidential procedure in such a case. 3. Once the Chair of the committee has declared that the confidential procedure is to be applied, the meeting shall be in camera and may be attended only by members of the committee, including substitute members. The committee may decide, in compliance with the applicable inter-institutional legal framework, that other Members may attend the meeting pursuant to Rule 216(3). The meeting may also be attended by those persons who have been designated in advance by the Chair, as having a need-to-know, in due respect of any restrictions stemming from the applicable rules governing the treatment of confidential information by Parliament. As regards the consultation of classified information at the level of CONFIDENTIEL UE/EU CONFIDENTIAL and above, or in case of specific limitations of access stemming from the interinstitutional legal framework, additional restrictions may apply. The documents shall be distributed at the beginning of the meeting and collected again at the end. They shall be numbered. No notes and no photocopies may be taken. The minutes of the meeting shall make no mention of the discussion of the item dealt with under the confidential procedure. Only the relevant decision, if any, may be recorded. 4. Without prejudice to the applicable rules on breach of confidentiality in general, Members or a political group or groups reaching at least the medium threshold in the committee which has applied the confidential procedure may request consideration of a breach of confidentiality. This request may be placed on the agenda of the next committee meeting. By a majority of its members, the committee may decide to submit the matter to the President for further consideration under Rules 10 and 176. This Rule applies to the extent that the applicable legal framework relating to the treatment of confidential information provides for the possibility of consulting the confidential information at a meeting in camera outside the secure facilities. Rule 222 Public hearings and debates on citizens' initiatives 1. When the Commission has published a citizens' initiative in the relevant register pursuant to point (a) of Article 10(1) of Regulation (EU) No 211/2011 of the European Parliament and of the Council (52), the President of the European Parliament, on a proposal from the Chair of the Conference of Committee Chairs: (a) shall task the committee responsible for the subject-matter according to Annex VI with organising the public hearing provided for in Article 11 of Regulation (EU) No 211/2011; the committee responsible for petitions shall be automatically associated under Rule 57; (b) may, where two or more citizens' initiatives published in the relevant register pursuant to point (a) of Article 10(1) of Regulation (EU) No 211/2011 have a similar subject-matter, decide, after consulting the organisers, that a joint public hearing is to be organised at which all of the citizens' initiatives involved shall be dealt with on an equal footing. 2. The committee responsible for the subject-matter: (a) shall ascertain whether the Commission has received the organisers at an appropriate level in accordance with point (b) of Article 10(1) of Regulation (EU) No 211/2011; (b) shall ensure, if necessary with the support of the Conference of Committee Chairs, that the Commission is properly involved in organising the public hearing and that it is represented at an appropriate level at the hearing. 3. The Chair of the committee responsible for the subject-matter shall convene the public hearing at an appropriate date within three months of the submission of the initiative to the Commission pursuant to Article 9 of Regulation (EU) No 211/2011. 4. The committee responsible for the subject matter shall organise the public hearing at Parliament, if appropriate together with such other institutions and bodies of the Union that wish to participate. It may invite other stakeholders to attend. The committee responsible for the subject matter shall invite a representative group of organisers, including at least one of the contact persons referred to in the second subparagraph of Article 3(2) of Regulation (EU) No 211/2011, to present the initiative at the hearing. 5. The Bureau shall, in accordance with the arrangements agreed with the Commission, adopt rules concerning the reimbursement of incurred costs. 6. The President of Parliament and the Chair of the Conference of Committee Chairs may delegate their powers under this Rule to a Vice-President and another committee Chair respectively. 7. If the conditions laid down in Rule 57 or Rule 58 are met, those provisions shall also apply, mutatis mutandis, to other committees. Rules 210 and 211 shall also apply. Rule 25(9) shall not apply to public hearings on citizens' initiatives. 8. Parliament shall hold a debate on a citizens' initiative published in the relevant register pursuant to point (a) of Article 10(1) of Regulation (EU) No 211/2011, at a part-session following the public hearing and shall, when placing the debate on its agenda, decide whether or not to wind up the debate with a resolution. It shall not wind up the debate with a resolution if a report on an identical or similar subject matter is scheduled for the same or the next part-session, unless the President, for exceptional reasons, proposes otherwise. If Parliament decides to wind up a debate with a resolution, the committee responsible for the subject matter or a political group or Members reaching at least the low threshold may table a motion for a resolution. Rule 132(3) to (8) concerning the tabling and voting of motions for resolutions shall apply mutatis mutandis. 9. Following the Commission's communication setting out its legal and political conclusions on a specific citizens' initiative, Parliament shall assess the actions taken by the Commission as a result of such communication. In the event that the Commission fails to submit an appropriate proposal on a citizens' initiative, the committee responsible for the subject matter may organise a hearing in consultation with the citizens' initiative organisers. Furthermore, Parliament may decide whether to hold a plenary debate and whether to wind up this debate with a resolution. The procedure set out in paragraph 8 shall apply mutatis mutandis. Parliament may also decide to exercise the right conferred on it by Article 225 of the Treaty on the Functioning of the European Union, thereby activating the procedure laid down in Rule 47. CHAPTER 2 Interparliamentary delegations Rule 223 Setting-up and duties of interparliamentary delegations 1. On a proposal from the Conference of Presidents, Parliament shall set up standing interparliamentary delegations and decide on their nature and the number of their members in the light of their duties. The members shall be appointed by the political groups and the non-attached Members during the first or second part-session following the re-election of Parliament for the duration of the parliamentary term. 2. The political groups shall ensure as far as possible that Member States, political views and gender are fairly represented. It shall not be permissible for more than one third of the members of a delegation to have the same nationality. Rule 209 shall apply mutatis mutandis. 3. The bureaux of the delegations shall be constituted in accordance with the procedure laid down for the standing committees in Rule 213. 4. Parliament shall determine the general powers of the individual delegations. It may at any time decide to increase or restrict those powers. 5. The implementing provisions needed to enable the delegations to carry out their work shall be adopted by the Conference of Presidents on a proposal from the Conference of Delegation Chairs. 6. The Chair of a delegation shall regularly report back to the committee responsible for foreign affairs on the activities of the delegation. 7. The Chair of a delegation shall be given an opportunity to be heard by a committee when an item on the agenda touches on the delegation's area of responsibility. The same shall apply to the Chair or rapporteur of that committee in the case of meetings of the delegation. Rule 224 Joint parliamentary committees 1. The European Parliament may set up joint parliamentary committees with the parliaments of States associated with the Union or States with which the Union has commenced accession negotiations. Such committees may formulate recommendations for the parliaments involved. In the case of the European Parliament, these recommendations shall be referred to the committee responsible, which shall put forward proposals on the action to be taken. 2. The general responsibilities of the various joint parliamentary committees shall be defined by the European Parliament, in accordance with the agreements with the third countries. 3. Joint parliamentary committees shall be governed by the procedures laid down in the relevant agreement. Such procedures shall be based on the principle of parity between the delegation of the European Parliament and that of the parliament involved. 4. Joint parliamentary committees shall draw up their own rules of procedure and submit them for approval, within the European Parliament to its Bureau, and within the third country parliament involved to the latter's relevant body. 5. The appointment of the members of the European Parliament's delegations to joint parliamentary committees and the constitution of the bureaux of these delegations shall take place in accordance with the procedure laid down for interparliamentary delegations. Rule 225 Cooperation with the Parliamentary Assembly of the Council of Europe 1. Parliament's bodies, and in particular its committees, shall cooperate with their counterparts at the Parliamentary Assembly of the Council of Europe in fields of mutual interest, with the aim in particular of improving the efficiency of their work and avoiding duplication of effort. 2. The Conference of Presidents, in agreement with the competent authorities of the Parliamentary Assembly of the Council of Europe, shall decide on the arrangements for that cooperation. TITLE IX PETITIONS Rule 226 Right of petition 1. In accordance with Article 227 of the Treaty on the Functioning of the European Union, any citizen of the European Union and any natural or legal person residing or having its registered office in a Member State shall have the right to address, individually or in association with other citizens or persons, a petition to Parliament on a matter which comes within the European Union's fields of activity and which affects him, her or it directly. 2. Petitions to Parliament shall show the name and the permanent address of each petitioner. 3. Submissions to Parliament that are clearly not intended to be a petition shall not be registered as petitions; instead, they shall be forwarded without delay to the appropriate service for further treatment. 4. Where a petition is signed by several natural or legal persons, the signatories shall designate a representative and deputy representatives who shall be regarded as the petitioners for the purposes of this Title. If no such representatives have been designated the first signatory or another appropriate person shall be regarded as the petitioner. 5. Each petitioner may at any time withdraw his, her or its signature from the petition. If all petitioners withdraw their signatures, the petition shall become null and void. 6. Petitions must be written in an official language of the European Union. Petitions written in any other language will be considered only if the petitioner has attached a translation in an official language. Parliament's correspondence with the petitioner shall employ the official language in which the translation is drawn up. The Bureau may decide that petitions and correspondence with petitioners may be drafted in other languages which, in accordance with the constitutional order of the Member States concerned, enjoy official status in all or part of their territory. 7. Petitions can be submitted either by post or through the Petitions portal, which shall be made available on Parliament's website and which shall guide the petitioner to formulate the petition in a manner that complies with paragraphs 1 and 2. 8. Where several petitions are received on a similar subject matter, they may be dealt with jointly. 9. Petitions shall be entered in a register in the order in which they are received if they comply with the conditions laid down in paragraph 2. Petitions that do not comply with those conditions shall be filed, and the petitioner shall be informed of the reasons for this. 10. Petitions entered in the register shall be forwarded by the President to the committee responsible for petitions, which shall first establish the admissibility of the petition in accordance with Article 227 of the Treaty on the Functioning of the European Union. If the committee fails to reach a consensus on the admissibility of the petition, it shall, at the request of at least one-third of the members of the committee, be declared admissible. 11. Petitions that have been declared inadmissible by the committee shall be filed. The petitioner shall be informed of the decision and the reasons for it. Where possible, alternative means of redress may be recommended. 12. Petitions, once registered, shall become public documents, and the name of the petitioner, possible co-petitioners and possible supporters and the contents of the petition may be published by Parliament for reasons of transparency. The petitioner, co-petitioners and supporters shall be informed accordingly. 13. Notwithstanding paragraph 12, the petitioner, a co-petitioner or a supporter may request that his, her or its name be withheld in order to protect his, her or its privacy, in which case Parliament shall comply with the request. Where the petitioner's complaint cannot be investigated because of the petitioner's anonymity, the petitioner shall be consulted on the further steps to be taken. 14. In order to protect the rights of third parties, Parliament may, on its own motion or at the request of the third party concerned, anonymise a petition and/or other data contained therein, if it sees fit to do so. 15. Petitions addressed to Parliament by natural or legal persons who are neither citizens of the European Union nor reside in a Member State nor have their registered office in a Member State shall be registered and filed separately. The President shall send a monthly record of such petitions received during the previous month, indicating their subject-matter, to the committee. The committee may ask to see those which it wishes to consider. Rule 227 Examination of petitions 1. Admissible petitions shall be considered by the committee responsible for petitions in the course of its normal activity, either through discussion at a regular meeting or by written procedure. Petitioners may be invited to participate in meetings of the committee if their petition is to be the subject of discussion, or they may ask to be present. The right to speak shall be granted to petitioners at the discretion of the Chair. 2. With regard to an admissible petition, the committee may decide to submit a short motion for a resolution to Parliament, provided that the Conference of Committee Chairs is informed in advance and there is no objection by the Conference of Presidents. Such motions for resolutions shall be placed on the draft agenda of the part-session to be held no later than eight weeks after the adoption of those motions for resolutions in the committee. They shall be put to a single vote. The Conference of Presidents may propose to apply Rule 160, failing which those motions for resolutions shall be put to the vote without debate. 3. Where, with regard to an admissible petition, the committee intends to draw up under Rule 54(1) an own initiative report dealing with, in particular, the application or interpretation of Union law or proposed changes to existing law, the committee responsible for the subject-matter shall be associated in accordance with Rule 56 and Rule 57. The committee shall without a vote accept suggestions for parts of the motion for a resolution received from the committee responsible for the subject-matter where those suggestions deal with the application or interpretation of Union law or changes to existing law. If the committee does not accept such suggestions, the committee responsible for the subject matter may table them directly in plenary. 4. Signatories may lend support to, or withdraw support from, an admissible petition on the Petitions Portal. That portal shall be made available on Parliament's website. 5. The committee may request assistance from the Commission particularly in the form of information on the application of, or compliance with, Union law and information or documents relevant to the petition. Representatives of the Commission shall be invited to attend meetings of the committee. 6. The committee may ask the President to forward its opinion or recommendation to the Commission, the Council or the Member State authority concerned for its action or response. 7. The committee shall report to Parliament annually on the outcome of its deliberations and, where appropriate, on the measures taken by the Council or the Commission on petitions referred to them by Parliament. When consideration of an admissible petition has been concluded, it shall be declared closed by a decision of the committee. 8. The petitioner shall be informed of all relevant decisions taken by the committee and the reasons thereof. 9. A petition may be re-opened by committee decision, if relevant new facts relating to the petition have been brought to its attention and the petitioner so requests. 10. By a majority of its members, the committee shall adopt guidelines for the treatment of petitions in accordance with these Rules of Procedure. Rule 228 Fact-finding visits 1. When investigating petitions, establishing facts or seeking solutions the committee may organise fact-finding visits to the Member State or region that are concerned by admissible petitions that have been already debated in the committee. As a general rule, fact-finding visits shall cover issues raised in several petitions. The Bureau Rules governing committee delegations within the European Union shall apply. 2. Members elected in the Member State of destination shall not be part of the delegation. They may be allowed to accompany the fact-finding visit delegation in an ex officio capacity. 3. After each visit, a mission report shall be drafted by the official members of the delegation. The Head of the delegation shall coordinate the drafting of the report and shall seek consensus on its content among the official members on an equal footing. Failing such a consensus, the mission report shall set out the divergent assessments. Members taking part in the delegation ex officio shall not participate in the drafting of the report. 4. The mission report, including possible recommendations, shall be submitted to the committee. Members may table amendments to the recommendations, but not to the parts of the report concerning the facts established by the delegation. The committee shall first vote on the amendments to the recommendations, if any, then on the mission report as a whole. The mission report, if approved, shall be forwarded to the President, for information. Rule 229 Notice of petitions 1. Notice shall be given in Parliament of the petitions entered in the register referred to in Rule 226(9) and the main decisions on the procedure to be followed in relation to specific petitions. Such announcements shall be entered in the minutes of proceedings. 2. The title and a summary of the texts of petitions entered in the register, together with the texts of the opinions and the most important decisions forwarded in connection with the examination of the petitions, shall be made available to the public on the Petitions Portal on Parliament's website. Rule 230 Citizens' initiative 1. When Parliament is informed that the Commission has been invited to submit a proposal for a legal act under Article 11(4) of the Treaty on European Union and in accordance with Regulation (EU) No 211/2011, the committee responsible for petitions shall ascertain whether this is likely to affect its work and, if need be, shall inform those petitioners who have addressed petitions on related subjects. 2. Proposed citizens' initiatives which have been registered in accordance with Article 4 of Regulation (EU) No 211/2011, but which cannot be submitted to the Commission in accordance with Article 9 of that Regulation since not all the relevant procedures and conditions laid down have been complied with, may be examined by the committee responsible for petitions if it considers that follow-up is appropriate. Rules 226, 227, 228 and 229 shall apply mutatis mutandis. TITLE X OMBUDSMAN Rule 231 Election of the Ombudsman 1. At the start of each parliamentary term or in the case of death, resignation or dismissal of the Ombudsman, the President shall call for nominations for the office of Ombudsman and set a time limit for their submission. A notice calling for nominations shall be published in the Official Journal of the European Union. 2. Nominations must have the support of at least 40 Members who are nationals of at least two Member States. Each Member may support only one nomination. Nominations shall include all the supporting documents needed to show conclusively that the nominee fulfils the conditions laid down in Article 6(2) of Decision 94/262/ECSC, EC, Euratom of the European Parliament (53). 3. Nominations shall be forwarded to the committee responsible. A full list of the Members who have given their support to the nominees shall be made available to the public in due time. 4. The committee responsible may ask to hear the nominees. Such hearings shall be open to all Members. 5. A list of admissible nominations in alphabetical order shall then be submitted to the vote of Parliament. 6. The Ombudsman shall be elected by a majority of the votes cast. If no candidate is elected after the first two ballots, only the two candidates obtaining the largest number of votes in the second ballot may continue to stand. In the event of any tie the oldest candidate shall be appointed. 7. Before opening the vote, the President shall ensure that at least half of Parliament's component Members are present. 8. The Ombudsman shall exercise his or her duties until his or her successor takes office, except in the case of his or her death or dismissal. Rule 232 Activities of the Ombudsman 1. The committee responsible shall examine cases of maladministration that it has been informed of by the Ombudsman pursuant to Article 3(6) and (7) of Decision 94/262/ECSC, EC, Euratom, following which it may decide to draw up a report under Rule 54. The committee responsible shall examine the report submitted by the Ombudsman at the end of each annual session on the outcome of his or her inquiries, in accordance with Article 3(8) of Decision 94/262/ECSC, EC, Euratom. The committee responsible may submit a motion for resolution to Parliament if it considers that Parliament needs to take a position in respect of any aspect of that report. 2. The Ombudsman may also provide the committee responsible with information at its request, or be heard by it on his or her own initiative. Rule 233 Dismissal of the Ombudsman 1. One tenth of Parliament's component Members may request the dismissal of the Ombudsman if he or she no longer fulfils the conditions required for the performance of his or her duties or is guilty of serious misconduct. Where such a request for dismissal has been voted on in the preceding two months, a new one may only be tabled by one fifth of the component Members of Parliament. 2. The request shall be forwarded to the Ombudsman and to the committee responsible, which, if it decides by a majority of its members that the reasons are well founded, shall submit a report to Parliament. If he or she so requests, the Ombudsman shall be heard before the report is put to the vote. Parliament shall, following a debate, take a decision by secret ballot. 3. Before taking the vote, the President shall ensure that at least half of Parliament's component Members are present. 4. If the vote is in favour of the Ombudsman's dismissal and he or she does not resign, the President shall, at the latest by the part-session following that at which the vote was held, apply to the Court of Justice to have the Ombudsman dismissed and request that a ruling be given without delay. Resignation by the Ombudsman shall terminate the procedure. TITLE XI PARLIAMENT'S SECRETARIAT Rule 234 Parliament's Secretariat 1. Parliament shall be assisted by a Secretary-General appointed by the Bureau. The Secretary-General shall give a solemn undertaking before the Bureau to perform his or her duties conscientiously and with absolute impartiality. 2. The Secretary-General shall head a Secretariat the composition and organisation of which shall be determined by the Bureau. 3. The Bureau shall decide on the establishment plan of Parliament's Secretariat and lay down regulations relating to the administrative and financial situation of officials and other servants. The President of Parliament shall inform the appropriate institutions of the European Union accordingly. TITLE XII POWERS AND RESPONSIBILITIES RELATING TO EUROPEAN POLITICAL PARTIES AND EUROPEAN POLITICAL FOUNDATIONS Rule 235 Powers and responsibilities relating to European political parties and European political foundations (54) 1. Where, in accordance with Article 65(1) of the Financial Regulation, Parliament decides to reserve to itself the right to authorise expenditure, it shall act through its Bureau. On this basis, the Bureau shall be competent to adopt decisions under Articles 17, 18, 24, 27(3) and 30 of Regulation (EU, Euratom) No 1141/2014 of the European Parliament and of the Council (55). Individual decisions adopted by the Bureau on the basis of this paragraph shall be signed by the President on its behalf and shall be notified to the applicant or to the beneficiary in accordance with Article 297 of the Treaty on the Functioning of the European Union. Individual decisions shall state the reasons on which they are based in accordance with the second paragraph of Article 296 of that Treaty. The Bureau may at any time consult the Conference of Presidents. 2. At the request of one quarter of the component Members of Parliament representing at least three political groups, Parliament shall vote on the decision to request, in accordance with Article 10(3) of Regulation (EU, Euratom) No 1141/2014, the Authority for European Political Parties and European Political Foundations to verify whether a registered European political party or a registered European political foundation complies with the conditions laid down in point (c) of Article 3(1) and point (c) of Article 3(2) of Regulation (EU, Euratom) No 1141/2014. 3. On the basis of the first subparagraph of Article 10(3) of Regulation (EU, Euratom) No 1141/2014, a group of at least 50 citizens may submit a reasoned request inviting Parliament to request the verification mentioned in paragraph 2. That reasoned request shall not be launched or signed by Members. It shall include substantial factual evidence showing that the European political party or European political foundation in question does not comply with the conditions referred to in paragraph 2. The President shall forward admissible requests from groups of citizens to the committee responsible for further examination. Following that examination, which should take place within four months from the President's referral, the committee responsible may, by a majority of its component members representing at least three political groups, submit a proposal to follow up the request and inform the President thereof. The group of citizens shall be informed of the outcome of the committee's examination. Upon reception of the committee proposal, the President shall communicate the request to Parliament. Following such a communication, Parliament shall, by a majority of the votes cast, decide on whether or not to lodge a request to the Authority for European Political Parties and European Political Foundations. The committee shall adopt guidelines for the treatment of such requests from groups of citizens. 4. At the request of one quarter of the component Members of Parliament representing at least three political groups, Parliament shall vote on a proposal for a reasoned decision to object, pursuant to Article 10(4) of Regulation (EU, Euratom) No 1141/2014, to the decision of the Authority for European Political Parties and European Political Foundations to deregister a European political party or a European political foundation within three months of the communication of the decision. The committee responsible shall submit a proposal for a reasoned decision. If this proposal is rejected, the contrary decision shall be deemed to have been adopted. 5. On the basis of a proposal by the committee responsible, the Conference of Presidents shall appoint two members of the committee of independent eminent persons pursuant to Article 11(1) of Regulation (EU, Euratom) No 1141/2014. TITLE XIII APPLICATION AND AMENDMENT OF THE RULES OF PROCEDURE Rule 236 Application of the Rules of Procedure 1. If doubt arises over the application or interpretation of these Rules of Procedure, the President may refer the matter to the committee responsible for examination. Committee Chairs may do so when such a doubt arises in the course of the committee's work and is related to it. 2. The committee shall decide whether it is necessary to propose an amendment to the Rules of Procedure. If this should be the case, it shall proceed in accordance with Rule 237. 3. If the committee decides that an interpretation of the existing Rules is sufficient, it shall forward its interpretation to the President, who shall inform Parliament thereof at its next part-session. 4. If a political group or Members reaching at least the low threshold contest the committee's interpretation within a period of 24 hours following its announcement, the matter shall be put to the vote in Parliament. Adoption of the text shall be by a majority of the votes cast, provided that at least one third of Parliament's component Members are present. In the event of rejection, the matter shall be referred back to the committee. 5. Uncontested interpretations and interpretations adopted by Parliament shall be appended in italic print as explanatory notes to the appropriate Rule or Rules. 6. Interpretations shall constitute precedents for the future application and interpretation of the Rules concerned. 7. The Rules of Procedure and interpretations shall be reviewed regularly by the committee responsible. 8. Where these Rules confer rights on a specific number of Members, that number shall be automatically adjusted to the nearest whole number representing the same percentage of Parliament's membership whenever the total size of Parliament is modified, in particular following enlargements of the European Union. Rule 237 Amendment of the Rules of Procedure 1. Any Member may propose amendments to these Rules and to their annexes accompanied, where appropriate, by short justifications. The committee responsible shall examine them and decide whether to submit them to Parliament. For the purpose of applying Rules 180, 181 and 183 to consideration of such proposed amendments in Parliament, references made in those Rules to the ‘original text’ or the proposal for a legally binding act shall be considered as referring to the provision in force at the time. 2. In accordance with Article 232 of the Treaty on the Functioning of the European Union, amendments to these Rules shall be adopted only if they secure the votes of a majority of the component Members of Parliament. 3. Unless otherwise specified when the vote is taken, amendments to these Rules and to their annexes shall enter into force on the first day of the part-session following that of their adoption. TITLE XIV MISCELLANEOUS PROVISIONS Rule 238 The symbols of the Union 1. Parliament shall recognise and espouse the following symbols of the Union: — the flag showing a circle of twelve golden stars on a blue background, — the anthem based on the ‘Ode to Joy’ from the Ninth Symphony by Ludwig van Beethoven, — the motto ‘United in diversity’. 2. Parliament shall celebrate Europe Day on 9 May. 3. The flag shall be flown at all Parliament premises and on the occasion of official events. The flag shall be used in each meeting room of the Parliament. 4. The anthem shall be performed at the opening of each constitutive sitting and at other solemn sittings, particularly those to welcome heads of State or government or to greet new Members following enlargements. 5. The motto shall be reproduced on Parliament's official documents. 6. The Bureau shall examine the further use of the symbols within the Parliament. The Bureau shall lay down detailed provisions for the implementation of this Rule. Rule 239 Gender Mainstreaming The Bureau shall adopt a gender action plan aimed at incorporating a gender perspective in all Parliament's activities, at all levels and all stages. The gender action plan shall be monitored bi-annually and reviewed at least every five years. Rule 240 Unfinished business At the end of the last part-session before elections, all Parliament's unfinished business shall be deemed to have lapsed, subject to the provisions of the second paragraph. At the beginning of each parliamentary term, the Conference of Presidents shall take a decision on reasoned requests from parliamentary committees and other institutions to resume or continue the consideration of such unfinished business. These provisions shall not apply to petitions, citizens' initiatives and communications that do not require a decision. Rule 241 Corrigenda 1. If an error is identified in a text adopted by Parliament, the President shall, where appropriate, refer a draft corrigendum to the committee responsible. 2. If an error is identified in a text adopted by Parliament and agreed with other institutions, the President shall seek the agreement of those institutions on the necessary corrections before proceeding in accordance with paragraph 1. 3. The committee responsible shall examine the draft corrigendum and submit it to Parliament if it is satisfied that an error has occurred which can be corrected in the proposed manner. 4. The corrigendum shall be announced at the following part-session. It shall be deemed to have been approved unless, not later than 24 hours after its announcement, a request is made by a political group or Members reaching at least the low threshold that it be put to the vote. If the corrigendum is not approved, it shall be referred back to the committee responsible. The committee responsible may propose an amended corrigendum or close the procedure. 5. Approved corrigenda shall be published in the same way as the text to which they refer. Rule 79 shall apply mutatis mutandis. (1) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (2) Interinstitutional Agreement of 20 November 2002 between the European Parliament and the Council concerning access by the European Parliament to sensitive information of the Council in the field of security and defence policy (OJ C 298, 30.11.2002, p. 1). Framework Agreement of 20 October 2010 on relations between the European Parliament and the European Commission (OJ L 304, 20.11.2010, p. 47). Interinstitutional Agreement of 12 March 2014 between the European Parliament and the Council concerning the forwarding to and handling by the European Parliament of classified information held by the Council on matters other than those in the area of the common foreign and security policy (OJ C 95, 1.4.2014, p. 1). (3) Decision of the European Parliament of 23 October 2002 on the implementation of the Interinstitutional Agreement governing European Parliament access to sensitive Council information in the sphere of security and defence policy (OJ C 298, 30.11.2002, p. 4). Decision of the Bureau of 15 April 2013 concerning the rules governing the treatment of confidential information by the European Parliament (OJ C 96, 1.4.2014, p. 1). (4) See Annex II. (5) See Annex I. (6) Agreement of 16 April 2014 between the European Parliament and the European Commission on the transparency register for organisations and self-employed individuals engaged in EU policy-making and policy implementation (OJ L 277, 19.9.2014, p. 11). (7) Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-fraud Office (OLAF) (OJ L 136, 31.5.1999, p. 15). (8) Parliament Decision of 18 November 1999 concerning the terms and conditions for internal investigations in relation to the prevention of fraud corruption and any illegal activity detrimental to the Communities' interests. (9) Rule 14 applies mutatis mutandis to committees (see Rule 213(3)). (10) Rule 15 applies mutatis mutandis to committees (see Rule 213(3)). (11) Rule 16 applies mutatis mutandis to committees (see Rule 213(3)). (12) Rule 19 applies mutatis mutandis to committees (see Rule 213(3)). (13) Rule 20 applies mutatis mutandis to committees (see Rule 213(3)). (14) See Annex I. (15) Framework Agreement of 20 October 2010 on relations between the European Parliament and the European Commission (OJ L 304, 20.11.2010, p. 47). (16) Interinstitutional Agreement of 13 April 2016 between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making (OJ L 123, 12.5.2016, p. 1). (17) Interinstitutional Agreement on Better-Law Making, paragraph 25. (18) See the relevant decision of the Conference of Presidents. (19) Code of Conduct for negotiating in the context of the ordinary legislative procedures. (20) Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (OJ C 373, 20.12.2013, p. 1). (21) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (22) See Annex V. (23) Interinstitutional Agreement of 20 December 1994, Accelerated working method for official codification of legislative texts, point 4 (OJ C 102, 4.4.1996, p. 2). (24) Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts (OJ C 77, 28.3.2002, p. 1), point 9. (25) Council Decision 1999/468/EC of 28 June 1999 laying down procedures for the exercise of the implementing powers conferred on the Commission (OJ L 184, 17.7.1999, p. 23). (26) Rule 112(4) shall be deleted from the Rules of Procedure as soon as the regulatory procedure with scrutiny has been totally removed from existing legislation. (27) See Annex VII. (28) See Annex III. (29) See Annex III. (30) Extended by Parliament's decision of 12 March 2019. (31) Rule 171(2) applies mutatis mutandis to committees (see Rule 216(4)). (32) Rule 174 applies mutatis mutandis to committees (see Rule 219). (33) Rule 179 applies mutatis mutandis to committees (see Rule 219). (34) Rule 180 applies mutatis mutandis to committees (see Rule 219). (35) Rule 181 applies mutatis mutandis to committees (see Rule 219). (36) Rule 182 applies mutatis mutandis to committees (see Rule 219). (37) Rule 183 applies mutatis mutandis to committees (see Rule 219). (38) Rule 185(1) applies mutatis mutandis to committees (see Rule 219). (39) Rule 186 applies mutatis mutandis to committees (see Rule 219). (40) Rule 187 applies mutatis mutandis to committees (see Rule 219). (41) Rule 189 applies mutatis mutandis to committees (see Rule 219). (42) Rule 190(3) and (4) applies mutatis mutandis to committees (see Rule 219). (43) Rule 191 applies mutatis mutandis to committees (see Rule 219). (44) Rule 192 applies mutatis mutandis to committees (see Rule 219). (45) Rule 193 applies mutatis mutandis to committees (see Rule 219). (46) Rule 195 applies mutatis mutandis to committees (see Rule 219). (47) Rule 200 applies mutatis mutandis to committees (see Rule 219). (48) Rule 201 applies mutatis mutandis to committees (see Rule 219). (49) Rule 204 (2), (3) and (5) applies mutatis mutandis to committees where a verbatim report is drawn up (see Rule 216(5)). (50) See Annex VI. (51) Decision 95/167/EC, Euratom, ECSC of the European Parliament, the Council and the Commission of 19 April 1995 on the detailed provisions governing the exercise of the European Parliament's right of inquiry (OJ L 113, 19.5.1995, p. 1.). (52) Regulation (EU) No 211/2011 of the European Parliament and of the Council of 16 February 2011 on the citizens' initiative (OJ L 65, 11.3.2011, p. 1). (53) Decision 94/262/ECSC, EC, Euratom of the European Parliament of 9 March 1994 on the regulations and general conditions governing the performance of the Ombudsman's duties (OJ L 113, 4.5.1994, p. 15). (54) Rule 235 shall only apply to European political parties and European political foundations within the meaning of Article 2 (3) and (4) of Regulation (EU, Euratom) No 1141/2014. (55) Regulation (EU, Euratom) No 1141/2014 of the European Parliament and of the Council of 22 October 2014 on the statute and funding of European political parties and European political foundations (OJ L 317, 4.11.2014, p. 1). ANNEX I CODE OF CONDUCT FOR MEMBERS OF THE EUROPEAN PARLIAMENT WITH RESPECT TO FINANCIAL INTERESTS AND CONFLICTS OF INTEREST Article 1 Guiding principles In exercising their duties, Members of the European Parliament: (a) are guided by and observe the following general principles of conduct: disinterest, integrity, openness, diligence, honesty, accountability and respect for Parliament's reputation; (b) act solely in the public interest and refrain from obtaining or seeking to obtain any direct or indirect financial benefit or other reward. Article 2 Main duties of Members In exercising their duties, Members of the European Parliament shall: (a) not enter into any agreement to act or vote in the interest of any other legal or natural person that would compromise their voting freedom, as enshrined in Article 6 of the Act of 20 September 1976 concerning the election of the members of the European Parliament by direct universal suffrage and Article 2 of the Statute for Members of the European Parliament; (b) not solicit, accept or receive any direct or indirect benefit or other reward, whether in cash or in kind, in exchange for specific behaviour in the scope of the Member's parliamentary work, and shall consciously seek to avoid any situation which might imply bribery, corruption, or undue influence; (c) not engage in paid professional lobbying directly linked to the Union decision-making process. Article 3 Conflicts of interest 1. A conflict of interest exists where a Member of the European Parliament has a personal interest that could improperly influence the performance of his or her duties as a Member. A conflict of interest does not exist where a Member benefits only as a member of the general public or of a broad class of persons. 2. Any Member who finds that he or she has a conflict of interest shall immediately take the necessary steps to address it, in accordance with the principles and provisions of this Code of Conduct. If the Member is unable to resolve the conflict of interest, he or she shall report this to the President in writing. In cases of ambiguity, the Member may seek advice in confidence from the Advisory Committee on the Conduct of Members, established under Article 7. 3. Without prejudice to paragraph 2, Members shall disclose, before speaking or voting in plenary or in one of Parliament's bodies, or if proposed as a rapporteur, any actual or potential conflict of interest in relation to the matter under consideration, where such conflict is not evident from the information declared pursuant to Article 4. Such disclosure shall be made in writing or orally to the chair during the parliamentary proceedings in question. Article 4 Declaration by Members 1. For reasons of transparency, Members of the European Parliament shall be personally responsible for submitting a declaration of financial interests to the President by the end of the first part-session after elections to the European Parliament (or within 30 days of taking up office with the Parliament in the course of a parliamentary term), in accordance with a form to be adopted by the Bureau pursuant to Article 9. They shall notify the President of any changes that have an influence on their declaration by the end of the month following each change occurring. 2. The declaration of financial interests shall contain the following information, which shall be provided in a precise manner: (a) the Member's occupation or occupations during the three-year period before he or she took up office with the Parliament, and his or her membership during that period of any boards or committees of companies, non-governmental organisations, associations or other bodies established in law; (b) any salary which the Member receives for the exercise of a mandate in another parliament; (c) any regular remunerated activity which the Member undertakes alongside the exercise of his or her office, whether as an employee or as a self-employed person; (d) membership of any boards or committees of any companies, non-governmental organisations, associations or other bodies established in law, or any other relevant outside activity that the Member undertakes, whether the membership or activity in question is remunerated or unremunerated; (e) any occasional remunerated outside activity (including writing, lecturing or the provision of expert advice), if the total remuneration of all the Member's occasional outside activities exceeds EUR 5 000 in a calendar year; (f) any holding in any company or partnership, where there are potential public policy implications or where that holding gives the Member significant influence over the affairs of the body in question; (g) any support, whether financial or in terms of staff or material, additional to that provided by Parliament and granted to the Member in connection with his or her political activities by third parties, whose identity shall be disclosed; (h) any other financial interests which might influence the performance of the Member's duties. For any item to be declared in accordance with the first subparagraph, Members shall, where appropriate, indicate whether it is remunerated or not; for items (a), (c), (d), (e) and (f), Members shall also indicate one of the following income categories: — Unremunerated, — EUR 1 to EUR 499 a month, — EUR 500 to EUR 1 000 a month, — EUR 1 001 to EUR 5 000 a month, — EUR 5 001 to EUR 10 000 a month, — above EUR 10 000 a month, with an indication of the nearest EUR 10 000 amount. Any income that Members receive in respect of each item declared in accordance with the first subparagraph, but not on a regular basis, shall be calculated on an annual basis, divided by twelve and placed in one of the categories set out in the second subparagraph. 3. The information provided to the President in accordance with this Article shall be published on Parliament's website in an easily accessible manner. 4. Members may not be elected as office-holders of Parliament or of one of its bodies, be appointed as a rapporteur or participate in an official delegation or interinstitutional negotiations, if they have not submitted their declaration of financial interests. 5. If the President receives information, which leads him or her to believe that the declaration of financial interests of a Member is substantially incorrect or out of date, the President may consult the advisory committee provided for in Article 7. Where appropriate, the President shall request the Member to correct his or her declaration within 10 days. The Bureau may adopt a decision applying paragraph 4 to Members who do not comply with the President's correction request. 6. Rapporteurs may voluntarily list in the explanatory statement to their report outside interests who have been consulted on matters pertaining to the subject of the report (1). Article 5 Gifts or similar benefits 1. Members of the European Parliament shall refrain from accepting, in the performance of their duties, any gifts or similar benefits, other than those with an approximate value of less than EUR 150 given in accordance with courtesy usage or those given to them in accordance with courtesy usage when they are representing Parliament in an official capacity. 2. Any gifts presented to Members in accordance with paragraph 1 when they are representing Parliament in an official capacity shall be handed over to the President and dealt with in accordance with implementing measures to be laid down by the Bureau pursuant to Article 9. 3. The provisions of paragraphs 1 and 2 shall not apply to the reimbursement of travel, accommodation and subsistence expenses of Members, or to the direct payment of such expenses by third parties, when Members attend, pursuant to an invitation and in the performance of their duties, at any events organised by third parties. The scope of this paragraph, and in particular the rules designed to ensure transparency, shall be specified in the implementing measures to be laid down by the Bureau pursuant to Article 9. Article 6 Activities of former Members Former Members of the European Parliament who engage in professional lobbying or representational activities directly linked to the European Union decision-making process should inform the European Parliament thereof and may not, throughout the period in which they engage in those activities, benefit from the facilities granted to former Members under the rules laid down by the Bureau to that effect (2). Article 7 Advisory Committee on the Conduct of Members 1. An Advisory Committee on the Conduct of Members (‘the Advisory Committee’) is hereby established. 2. The Advisory Committee shall be composed of five members, appointed by the President at the beginning of his or her term of office from amongst the members of the Committee on Constitutional Affairs and the Committee on Legal Affairs, taking due account of the Members' experience and of political balance. Each member of the Advisory Committee shall serve as chair for six months on a rotating basis. 3. The President shall also, at the beginning of his or her term of office, appoint reserve members for the Advisory Committee, one for each political group not represented in the Advisory Committee. In the event of an alleged breach of this Code of Conduct by a member of a political group not represented in the Advisory Committee, the relevant reserve member shall serve as a sixth full member of the Advisory Committee for the purposes of investigation of that alleged breach. 4. Upon request by a Member, the Advisory Committee shall give him or her, in confidence and within 30 calendar days, guidance on the interpretation and implementation of the provisions of this Code of Conduct. The Member in question shall be entitled to rely on such guidance. At the request of the President, the Advisory Committee shall also assess alleged breaches of this Code of Conduct and advise the President on possible action to be taken. 5. The Advisory Committee may, after consulting the President, seek advice from outside experts. 6. The Advisory Committee shall publish an annual report of its work. Article 8 Procedure in the event of possible breaches of the Code of Conduct 1. Where there is reason to think that a Member of the European Parliament may have breached this Code of Conduct, the President shall, except in manifestly vexatious cases, refer the matter to the Advisory Committee. 2. The Advisory Committee shall examine the circumstances of the alleged breach, and may hear the Member concerned. Based on its findings, it shall make a recommendation to the President concerning a possible decision. In case of an alleged breach of the Code of Conduct by a permanent member or by a reserve member of the Advisory Committee, the member or reserve member concerned shall refrain from taking part in the proceedings of the Advisory Committee on that alleged breach. 3. If, taking into account that recommendation, and having invited the Member concerned to submit written observations, the President concludes that the Member concerned has breached the Code of Conduct, he or she shall adopt a reasoned decision laying down a penalty. The President shall notify that Member of the reasoned decision. The penalty may consist of one or more of the measures listed in Rule 176(4) to (6) of the Rules of Procedure. 4. The internal appeal procedures defined in Rule 177 of the Rules of Procedure shall be available to the Member concerned. Article 9 Implementation The Bureau shall lay down implementing measures for this Code of Conduct, including a monitoring procedure, and shall, when necessary, update the amounts referred to in Articles 4 and 5. The Bureau may bring forward proposals for revision of this Code of Conduct. (1) See Bureau Decision of 12 September 2016 on the implementation of the Inter-Institutional Agreement on the Transparency Register. (2) Bureau Decision of 12 April 1999 on facilities granted to former Members of the European Parliament. ANNEX II CODE OF APPROPRIATE BEHAVIOUR FOR MEMBERS OF THE EUROPEAN PARLIAMENT IN EXERCISING THEIR DUTIES 1. In exercising their duties, Members of the European Parliament will behave towards everyone working in the European Parliament with dignity, courtesy and respect and without prejudice or discrimination. 2. In exercising their duties, Members will behave in a professional manner and must refrain, in their relations with staff, from, in particular, degrading, insulting, offensive or discriminatory language or any other actions which are unethical, demeaning or unlawful. 3. Members may not, by their actions, incite or encourage staff to violate, circumvent or ignore the legislation in force, Parliament’s internal rules or this Code, or tolerate such behaviour by staff under their responsibility. 4. With the aim of ensuring that the European Parliament functions effectively, Members will seek to ensure, exercising appropriate discretion, that any disagreements or conflicts involving staff under their responsibility are handled promptly, fairly and effectively. 5. Where necessary, Members will cooperate promptly and fully with the procedures in place for managing situations of conflict or harassment (psychological or sexual), including responding promptly to any allegations of harassment. Members should take part in specialised training organised for them on preventing conflict and harassment in the workplace and on good office management. 6. Members will sign a declaration confirming their commitment to complying with this Code. All declarations, whether signed or not, will be published on Parliament’s website. 7. Members who have not signed the declaration relating to this Code may not be elected as office-holders of Parliament or of one of its bodies, be appointed as a rapporteur or participate in an official delegation or interinstitutional negotiations. ANNEX III CRITERIA FOR QUESTIONS FOR WRITTEN ANSWER UNDER RULES 138, 140 AND 141 1. Questions for written answer shall: — clearly specify the addressee to whom they are to be transmitted through the usual interinstitutional channels, — fall exclusively within the limits of the competences of the addressee, as laid down in the relevant Treaties or in legal acts of the Union, or within its sphere of activity, — be of general interest, — be concise and contain an understandable interrogation, — not exceed 200 words, — not contain offensive language, — not relate to strictly personal matters, — not contain more than three sub-questions. 2. Questions to the Council may not deal with the subject of an ongoing ordinary legislative procedure or with Council’s budgetary functions. 3. Upon request, the Secretariat shall provide authors with advice on how to comply in an individual case with the criteria laid down in paragraph 1. 4. If an identical or similar question has been put and answered during the preceding six months, or to the extent that a question merely seeks information on the follow-up to a specific resolution of Parliament of a kind which the Commission has already provided in a written follow-up communication during the preceding six months, the Secretariat shall transmit to the author a copy of the previous question and answer or follow-up communication. The renewed question shall not be forwarded to the addressee unless the President so decides in the light of significant new developments and in response to a reasoned request by the author. 5. If a question seeks factual or statistical information that is already available to Parliament’s research services, it shall not be forwarded to the addressee but rather to those services, unless the President decides otherwise upon request by the author. 6. Questions concerning related matters may be merged into a single question by the Secretariat and answered together. ANNEX IV GUIDELINES AND GENERAL PRINCIPLES TO BE FOLLOWED WHEN CHOOSING THE SUBJECTS TO BE INCLUDED ON THE AGENDA FOR THE DEBATE ON CASES OF BREACHES OF HUMAN RIGHTS, DEMOCRACY AND THE RULE OF LAW PROVIDED FOR UNDER RULE 144 Fundamental principles 1. Priority shall be given to motions for resolutions intended to lead to a vote in Parliament addressed to the Council, the Commission, the Member States, third countries or international bodies, before a particular event, provided that the current part-session is the only part-session of the European Parliament at which a vote can be held in time. 2. Motions for resolutions shall not exceed 500 words. 3. Subjects relating to the responsibilities of the European Union as laid down by the Treaties shall be given priority, provided they are of major importance. 4. The number of subjects chosen shall be such as to allow a debate commensurate with their importance and should not exceed three, including sub-chapters. Practical details 5. The fundamental principles applied in determining the choice of subjects to be included in the debate on cases of breaches of human rights, democracy and the rule of law shall be notified to Parliament and the political groups. Limitation and allocation of speaking time 6. In order to make better use of the time available, the President, after consulting the political group Chairs, shall reach agreement with the Council and the Commission on the limitation of the speaking time for their respective statements, if any, in the debate on cases of breaches of human rights, democracy and the rule of law. Deadline for tabling amendments 7. The deadline for tabling amendments shall allow sufficient time between their distribution in the official languages and the time set for the debate on the motions for resolutions to enable Members and political groups to give them due consideration. ANNEX V PROCEDURE FOR THE CONSIDERATION AND ADOPTION OF DECISIONS ON THE GRANTING OF DISCHARGE Article 1 Documents 1. The following documents shall be printed and distributed: (a) the revenue and expenditure account, the financial analysis and the balance sheet forwarded by the Commission; (b) the Annual Report and special reports of the Court of Auditors, accompanied by the Institutions' answers; (c) the statement of assurance as to the reliability of the accounts and the legality and regularity of the underlying transactions provided by the Court of Auditors pursuant to Article 287 of the Treaty on the Functioning of the European Union; (d) the Council recommendation. 2. These documents shall be referred to the committee responsible. Any committee concerned may deliver an opinion. 3. If other committees wish to deliver opinions, the President shall set the time-limit within which these shall be communicated to the committee responsible. Article 2 Consideration of report 1. Parliament shall consider a report from the committee responsible concerning discharge by 30 April of the year following the adoption of the Court of Auditors' Annual Report as required by the Financial Regulation. 2. Parliament's Rules relating to amendments and voting shall apply unless otherwise provided in this Annex. Article 3 Content of the Report 1. The discharge report drawn up by the committee responsible shall comprise: (a) a proposal for a decision granting discharge or postponing the discharge decision (April part-session vote) or a proposal for a decision granting or refusing to grant discharge (October part-session vote); (b) a proposal for a decision closing the accounts of all the Union's revenue, expenditure, assets and liabilities; (c) a motion for a resolution containing comments accompanying the proposal for a decision referred to in point (a) including both an assessment of the Commission's budgetary management over the financial year and observations relating to the implementation of expenditure for the future; (d) as an Annex, a list of the documents received from the Commission and those requested but not received; (e) the opinions of the committees concerned. 2. If the committee responsible proposes postponing the discharge decision, the relevant motion for a resolution shall also set out, inter alia: (a) the reasons for postponement; (b) the further action that the Commission is expected to take and the deadlines for doing so; (c) the documents required for Parliament to take an informed decision. Article 4 Consideration and vote in Parliament 1. Any report by the committee responsible concerning the discharge shall be included on the agenda of the first part-session following its tabling. 2. Amendments shall be admissible only to the motion for a resolution tabled in accordance with Article 3(1)(c). 3. Unless otherwise stipulated in Article 5, the vote on the proposals for decisions and the motion for a resolution shall follow the order of Article 3. 4. Parliament shall decide by a majority of the votes cast, in accordance with Article 231 of the Treaty on the Functioning of the European Union. Article 5 Procedural variants 1. April part-session vote In the first instance, the discharge report shall propose either to grant or to postpone discharge. (a) If a proposal to grant discharge secures a majority, discharge is granted. This shall also constitute closure of the accounts. If a proposal to grant discharge fails to secure a majority, discharge shall be deemed to have been postponed and the committee responsible shall table a new report within six months containing a new proposal to grant or refuse to grant discharge. (b) If a proposal to postpone discharge is adopted, the committee responsible shall table a new report within six months containing a new proposal to grant or refuse to grant discharge. In this case the closure of accounts shall also be postponed and retabled with the new report. If a proposal to postpone discharge fails to secure a majority, discharge shall be deemed to have been granted. In this instance the decision shall also constitute closure of the accounts. The motion for resolution may still be put to the vote. 2. October part-session vote In the second instance, the discharge report shall propose either to grant or to refuse to grant discharge. (a) If a proposal to grant discharge secures a majority, discharge is granted. This shall also constitute closure of the accounts. If a proposal to grant discharge fails to secure a majority, this shall constitute refusal of discharge. A formal proposal to close the accounts for the year in question shall be submitted at a subsequent part-session at which the Commission shall be invited to make a statement. (b) If a proposal to refuse discharge secures a majority, a formal proposal to close the accounts for the year in question shall be submitted at a subsequent part-session at which the Commission shall be invited to make a statement. If a proposal to refuse discharge fails to secure a majority, discharge shall be deemed to have been granted. In this instance the decision shall also constitute closure of accounts. The motion for resolution may still be put to the vote. 3. In the event that the motion for resolution or the proposal on closure contains provisions which contradict Parliament's vote on the discharge, the President, after consulting the Chair of the committee responsible, may postpone that vote and fix a new deadline for tabling amendments. Article 6 Implementation of discharge decisions 1. The President shall forward any decision or resolution of Parliament adopted pursuant to Article 3 to the Commission and to each of the other institutions and shall arrange for their publication in the Official Journal of the European Union in the series appropriate to acts of a legislative character. 2. The committee responsible shall report to Parliament at least annually on the action taken by the institutions in response to the comments accompanying the discharge decisions and the other comments contained in Parliament's resolutions concerning the implementation of expenditure. 3. On the basis of a report by the committee responsible for budgetary control, the President, acting on behalf of Parliament, may bring an action before the Court of Justice of the European Union against the institution concerned, pursuant to Article 265 of the Treaty on the Functioning of the European Union, for failure to comply with the obligations deriving from the comments accompanying the discharge decision or the other resolutions concerning implementation of expenditure. ANNEX VI POWERS AND RESPONSIBILITIES OF STANDING COMMITTEES (1) I. Committee on Foreign Affairs Committee responsible for the promotion, implementation and monitoring of the Union's foreign policy as regards: 1. the common foreign and security policy (CFSP) and the common security and defence policy (CSDP); in this context the committee is assisted by a subcommittee on security and defence; 2. relations with other Union institutions and bodies, the UNO and other international organisations and interparliamentary assemblies for matters falling under its responsibility; 3. oversight of the European External Action Service; 4. the strengthening of political relations with third countries by means of comprehensive cooperation and assistance programmes or international agreements such as association and partnership agreements; 5. the opening, monitoring and concluding of negotiations concerning the accession of European States to the Union; 6. all legislation, programming and scrutiny of actions carried out under the European Instrument for Democracy and Human Rights, the European Neighbourhood Instrument, the Instrument for Pre-Accession Assistance, the Instrument contributing to Stability and Peace and the Partnership Instrument for cooperation with third countries, and the policies underpinning them; 7. the monitoring and follow-up of, inter alia, the European Neighbourhood Policy (ENP), in particular with regard to ENP Annual Progress Reports; 8. issues concerning democracy, the rule of law, human rights, including the rights of minorities, in third countries and the principles of international law; in this context the committee is assisted by a subcommittee on human rights, which should ensure coherence between all the Union's external policies and its human rights policy; without prejudice to the relevant rules, members from other committees and bodies with responsibilities in this field shall be invited to attend the meetings of the subcommittee. 9. Parliament's involvement in election observation missions, where appropriate in cooperation with other relevant committees and delegations. The committee provides political oversight to, and coordinates the work of, joint parliamentary committees and parliamentary cooperation committees as well as that of the interparliamentary delegations and ad hoc delegations falling within its remit. II. Committee on Development Committee responsible for: 1. the promotion, implementation and monitoring of the development and cooperation policy of the Union, notably: (a) political dialogue with developing countries, bilaterally and in the relevant international organisations and interparliamentary for a; (b) aid to, and cooperation agreements with, developing countries, notably oversight of effective aid funding and evaluation of output, including in relation to poverty eradication; (c) monitoring of the relationship between the policies of the Member States and those implemented at Union level; (d) promotion of democratic values, good governance and human rights in developing countries; (e) the implementation, monitoring and advancement of policy coherence with regard to development policy; 2. all legislation, programming and scrutiny of actions carried out under the Development Cooperation Instrument (DCI), the European Development Fund (EDF) — in close cooperation with national parliaments — and the Humanitarian Aid Instrument, as well as all matters related to humanitarian aid in developing countries and the policy underpinning them; 3. matters relating to the ACP-EU Partnership Agreement and relations with the relevant bodies; 4. matters relating to Overseas Countries and Territories (OCTs); 5. Parliament's involvement in election observation missions, when appropriate in cooperation with other relevant committees and delegations. The committee coordinates the work of the interparliamentary delegations and ad hoc delegations falling within its remit. III. Committee on International Trade Committee responsible for matters relating to the establishment, implementation and monitoring of the Union's common commercial policy and its external economic relations, in particular: 1. financial, economic and trade relations with third countries and regional organisations; 2. the common external tariff and trade facilitation as well as the external aspects of customs provisions and management; 3. the opening, monitoring, conclusion and follow-up of bilateral, multilateral and plurilateral trade agreements governing economic, trade and investment relations with third countries and regional organisations; 4. measures of technical harmonisation or standardisation in fields covered by instruments of international law; 5. relations with the relevant international organisations and international fora on trade-related matters, and with organisations promoting regional economic and commercial integration outside the Union; 6. relations with the WTO, including its parliamentary dimension. The committee liaises with the relevant interparliamentary and ad hoc delegations for the economic and trade aspects of relations with third countries. IV. Committee on Budgets Committee responsible for: 1. the multiannual financial framework of the Union's revenue and expenditure and the Union's system of own resources; 2. Parliament's budgetary prerogatives, namely the budget of the Union as well as the negotiation and implementation of interinstitutional agreements in this field; 3. Parliament's estimates according to the procedure defined in the Rules; 4. the budget of the decentralised bodies; 5. the financial activities of the European Investment Bank which are not part of European economic governance; 6. the budgetisation of the European Development Fund, without prejudice to the powers of the committee responsible for the ACP-EU Partnership Agreement; 7. financial implications and compatibility with the multiannual financial framework of all Union acts, without prejudice to the powers of the relevant committees; 8. keeping track of and assessing the implementation of the current budget notwithstanding Rule 98(1), transfers of appropriations, procedures relating to the establishment plans, administrative appropriations and opinions concerning buildings-related projects with significant financial implications; 9. the Financial Regulation, excluding matters relating to the implementation, management and control of the budget. V. Committee on Budgetary Control Committee responsible for: 1. the control of the implementation of the budget of the Union and of the European Development Fund, and the decisions on discharge to be taken by Parliament, including the internal discharge procedure and all other measures accompanying or implementing such decisions; 2. the closure, presenting and auditing of the accounts and balance sheets of the Union, its institutions and any bodies financed by it, including the establishment of appropriations to be carried over and the settling of balances; 3. the control of the financial activities of the European Investment Bank; 4. monitoring of the cost-effectiveness of the various forms of Union financing in the implementation of the Union's policies, involving, upon the Committee on Budgetary Control's request, the specialised committees and acting, upon the Committee on Budgetary Control's request, in cooperation with the specialised committees for the examination of special reports of the Court of Auditors; 5. relations with the European Anti-Fraud Office (OLAF), consideration of fraud and irregularities in the implementation of the budget of the Union, measures aimed at preventing and prosecuting such cases, the strict protection of the Union's financial interests and the relevant actions by the European Public Prosecutor in this field; 6. relations with the Court of Auditors, the appointment of its members and consideration of its reports; 7. the Financial Regulation as far as the implementation, management and control of the budget are concerned. VI. Committee on Economic and Monetary Affairs Committee responsible for: 1. the economic and monetary policies of the Union, the functioning of Economic and Monetary Union and the European monetary and financial system (including relations with the relevant institutions or organisations); 2. the free movement of capital and payments (cross-border payments, single payment area, balance of payments, capital movements and borrowing and lending policy, control of movements of capital originating in third countries, measures to encourage the export of the Union's capital); 3. the international monetary and financial system (including relations with financial and monetary institutions and organisations); 4. rules on competition and State or public aid; 5. tax provisions; 6. the regulation and supervision of financial services, institutions and markets including financial reporting, auditing, accounting rules, corporate governance and other company law matters specifically concerning financial services; 7. the relevant financial activities of the European Investment Bank as part of European economic governance in the euro area. VII. Committee on Employment and Social Affairs Committee responsible for: 1. employment policy and all aspects of social policy including working conditions, social security, social inclusion and social protection; 2. workers' rights; 3. health and safety measures at the workplace; 4. the European Social Fund; 5. vocational training policy, including professional qualifications; 6. the free movement of workers and pensioners; 7. social dialogue; 8. all forms of discrimination at the workplace and in the labour market except those based on sex; 9. relations with: — the European Centre for the Development of Vocational Training (Cedefop), — the European Foundation for the Improvement of Living and Working Conditions, — the European Training Foundation, — the European Agency for Safety and Health at Work; as well as relations with other relevant Union bodies and international organisations. VIII. Committee on the Environment, Public Health and Food Safety Committee responsible for: 1. environmental policy and environmental protection measures, in particular concerning: (a) climate change; (b) air, soil and water pollution, waste management and recycling, dangerous substances and preparations, noise levels and the protection of biodiversity; (c) sustainable development; (d) international and regional measures and agreements aimed at protecting the environment; (e) restoration of environmental damage; (f) civil protection; (g) the European Environment Agency; (h) the European Chemicals Agency; 2. public health, in particular: (a) programmes and specific actions in the field of public health; (b) pharmaceutical and cosmetic products; (c) health aspects of bioterrorism; (d) the European Medicines Agency and the European Centre for Disease Prevention and Control; 3. food safety issues, including in particular: (a) the labelling and safety of foodstuffs; (b) veterinary legislation concerning protection against risks to human health; public health checks on foodstuffs and food production systems; (c) the European Food Safety Authority and the European Food and Veterinary Office. IX. Committee on Industry, Research and Energy Committee responsible for: 1. the Union's industrial policy and related measures, and the application of new technologies, including measures related to SMEs; 2. the Union's research and innovation policy, including science and technology as well as the dissemination and exploitation of research findings; 3. European space policy; 4. the activities of the Joint Research Centre, the European Research Council, the European Institute of Innovation and Technology and the Institute for Reference Materials and Measurements, as well as JET, ITER and other projects in the same area; 5. Union measures relating to energy policy in general and in the context of the establishment and functioning of the internal energy market, including measures relating to: (a) the security of energy supply in the Union; (b) the promotion of energy efficiency and energy saving and the development of new and renewable forms of energy; (c) the promotion of interconnection of energy networks and energy efficiency including the establishment and development of trans-European networks in the energy infrastructure sector; 6. the Euratom Treaty and Euratom Supply Agency; nuclear safety, decommissioning and waste disposal in the nuclear sector; 7. the information society, information technology and communications networks and services, including technologies and security aspects and the establishment and development of trans-European networks in the telecommunication infrastructure sector as well as the activities of the European Union Agency for Network and Information Security (ENISA). X. Committee on the Internal Market and Consumer Protection Committee responsible for: 1. coordination at Union level of national legislation in the sphere of the internal market and for the customs union, in particular: (a) the free movement of goods including the harmonisation of technical standards; (b) the right of establishment; (c) freedom to provide services except in the financial and postal sectors; 2. the functioning of the Single Market, including measures aimed at the identification and removal of potential obstacles to the implementation of the Single Market, including the Digital Single Market; 3. the promotion and protection of the economic interests of consumers, except for public health and food safety issues; 4. policy and legislation regarding the enforcement of Single Market rules and consumer rights. XI. Committee on Transport and Tourism Committee responsible for: 1. matters relating to the development of a common policy for rail, road, inland waterway, maritime and air transport, in particular: (a) common rules applicable to transport within the European Union; (b) the establishment and development of trans-European networks in the area of transport infrastructure; (c) the provision of transport services and relations in the field of transport with third countries; (d) transport safety; (e) relations with international transport bodies and organisations; (f) the European Maritime Safety Agency, the European Union Agency for Railways, the European Union Aviation Safety Agency and the SESAR Joint Undertaking; 2. postal services; 3. tourism. XII. Committee on Regional Development Committee responsible for: 1. the operation and development of the Union's regional development and cohesion policy, as established in the Treaties; 2. the European Regional Development Fund, the Cohesion Fund and the other instruments of the Union's regional policy; 3. assessment of the impact of other Union policies on economic and social cohesion; 4. coordination of the Union's structural instruments; 5. the urban dimension of the cohesion policy; 6. outermost regions and islands as well as trans-frontier and interregional cooperation; 7. relations with the Committee of the Regions, interregional cooperation organisations and local and regional authorities. XIII. Committee on Agriculture and Rural Development Committee responsible for: 1. the operation and development of the common agricultural policy; 2. rural development, including the activities of the relevant financial instruments; 3. legislation on: (a) veterinary and plant-health matters and animal feeding stuffs provided such measures are not intended to protect against risks to human health; (b) animal husbandry and welfare; 4. improvement of the quality of agricultural products; 5. supplies of agricultural raw materials; 6. the Community Plant Variety Office; 7. forestry and agroforestry. XIV. Committee on Fisheries Committee responsible for: 1. the operation and development of the common fisheries policy and its management; 2. the conservation of fishery resources, the management of fisheries and fleets exploiting such resources and marine and applied fisheries research; 3. the common organisation of the market in fishery and aquaculture products and the processing and marketing thereof; 4. structural policy in the fisheries and aquaculture sectors, including the financial instruments and funds for fisheries guidance to support these sectors; 5. the integrated maritime policy as regards fishing activities; 6. sustainable fisheries partnership agreements, regional fisheries organisations and the implementation of international obligations in the field of fisheries. XV. Committee on Culture and Education Committee responsible for: 1. the cultural aspects of the European Union, and in particular: (a) improving the knowledge and dissemination of culture; (b) the protection and promotion of cultural and linguistic diversity; (c) the conservation and safeguarding of cultural heritage, cultural exchanges and artistic creation; 2. the Union's education policy, including the European higher education area, the promotion of the system of European schools and lifelong learning; 3. audiovisual policy and the cultural and educational aspects of the information society; 4. youth policy; 5. the development of a sports and leisure policy; 6. information and media policy; 7. cooperation with third countries in the areas of culture and education and relations with the relevant international organisations and institutions. XVI. Committee on Legal Affairs Committee responsible for: 1. the interpretation, application and monitoring of Union law and compliance of Union acts with primary law, notably the choice of legal bases and respect for the principles of subsidiarity and proportionality; 2. the interpretation and application of international law, in so far as the European Union is affected; 3. better law-making and the simplification of Union law; 4. the legal protection of Parliament's rights and prerogatives, including its involvement in actions before the Court of Justice of the European Union; 5. Union acts which affect the Member States' legal order, namely in the fields of: (a) civil and commercial law; (b) company law; (c) intellectual property law; (d) procedural law; 6. measures concerning judicial and administrative cooperation in civil matters; 7. environmental liability and sanctions against environmental crime; 8. ethical questions related to new technologies, applying the associated committee procedure with the relevant committees; 9. the Statute for Members and the Staff Regulations of the European Union; 10. privileges and immunities as well as verification of Members' credentials; 11. the organisation and statute of the Court of Justice of the European Union; 12. the European Union Intellectual Property Office. XVII. Committee on Civil Liberties, Justice and Home Affairs Committee responsible for: 1. the protection within the territory of the Union of citizens' rights, human rights and fundamental rights, including the protection of minorities, as laid down in the Treaties and in the Charter of Fundamental Rights of the European Union; 2. the measures needed to combat all forms of discrimination other than those based on sex or those occurring at the workplace and in the labour market; 3. legislation in the areas of transparency and of the protection of natural persons with regard to the processing of personal data; 4. the establishment and development of an area of freedom, security and justice while respecting the principles of subsidiarity and proportionality, in particular: (a) measures concerning the entry and movement of persons, asylum and migration; (b) measures concerning an integrated management of the common borders; (c) measures relating to police and judicial cooperation in criminal matters, including terrorism, and substantive and procedural measures relating to the development of a more coherent Union approach to criminal law; 5. the European Monitoring Centre for Drugs and Drug Addiction and the European Union Agency for Fundamental Rights, Europol, Eurojust, CEPOL, the European Public Prosecutor's Office and other bodies and agencies in the same area; 6. the determination of a clear risk of a serious breach by a Member State of the principles common to the Member States. XVIII. Committee on Constitutional Affairs Committee responsible for: 1. the institutional aspects of the European integration process, in particular the preparation, initiation and proceedings of ordinary and simplified Treaty revision procedures; 2. the implementation of the Treaties and the assessment of their operation; 3. the institutional consequences of enlargement negotiations of or withdrawal from the Union; 4. interinstitutional relations, including, with a view to their approval by Parliament, examination of interinstitutional agreements pursuant to Rule 148(2) of the Rules of Procedure; 5. uniform electoral procedure; 6. political parties and political foundations at European level, without prejudice to the competences of the Bureau; 7. the determination of the existence of a serious and persistent breach by a Member State of the principles common to the Member States; 8. the interpretation and application of the Rules of Procedure and proposals for amendments thereto. XIX. Committee on Women's Rights and Gender Equality Committee responsible for: 1. the definition, promotion and protection of women's rights in the Union and related Union measures; 2. the promotion of women's rights in third countries; 3. equal opportunities policy, including the promotion of equality between men and women with regard to labour market opportunities and treatment at work; 4. the removal of all forms of violence and discrimination based on sex; 5. the implementation and further development of gender mainstreaming in all policy sectors; 6. the follow-up and implementation of international agreements and conventions involving the rights of women; 7. the encouragement of awareness of women's rights. XX. Committee on Petitions Committee responsible for: 1. petitions; 2. the organisation of public hearings on citizens' initiatives pursuant to Rule 222; 3. relations with the European Ombudsman. (1) Adopted by decision of Parliament of 15 January 2014. ANNEX VII APPROVAL OF THE COMMISSION AND MONITORING OF COMMITMENTS MADE DURING THE HEARINGS Part I — Parliament's consent with regard to the entire College of the Commission Article 1 Basis for assessment 1. Parliament shall evaluate Commissioners-designate based on their general competence, European commitment and personal independence. It shall assess knowledge of their prospective portfolio and their communication skills. 2. Parliament shall have particular regard to gender balance. It may express itself on the allocation of portfolio responsibilities by the President-elect. 3. Parliament may seek any information relevant to its reaching a decision on the aptitude of the Commissioners-designate. It shall expect full disclosure of information relating to their financial interests. The declarations of interest of the Commissioners-designate shall be sent for scrutiny to the committee responsible for legal affairs. Article 2 Examination of declaration of financial interests 1. The committee responsible for legal affairs shall examine the declarations of financial interests and assess whether the content of the declaration made by a commissioner-designate is accurate and complete and whether it is possible to infer a conflict of interests. 2. The confirmation by the committee responsible for legal affairs of the absence of any conflict of interests is an essential precondition for the holding of the hearing by the committee responsible for the subject matter. In the absence of such confirmation, the procedure for appointing the Commissioner-designate shall be suspended while the procedure laid down in paragraph 3(c) is followed. 3. The following guidelines shall be applied when the declarations of financial interests are scrutinised by the committee responsible for legal affairs: (a) if, when scrutinising a declaration of financial interests, the committee responsible for legal affairs deems, on the basis of the documents presented, the declaration to be accurate, complete and to contain nothing indicating an actual or potential conflict of interests in connection with the portfolio of the Commissioner-designate, its Chair shall send a letter confirming this finding to the committees responsible for the hearing or to the committees involved in the event of a procedure taking place during a Commissioner's term of office; (b) if the committee responsible for legal affairs considers that the declaration of interests of a Commissioner-designate contains information which is incomplete or contradictory, or that there is a need for further information, it shall, pursuant to the Framework Agreement on relations between the European Parliament and the European Commission, request the Commissioner-designate to provide supplementary information without undue delay and shall consider and properly analyse it before making its decision; the committee responsible for legal affairs may decide, where appropriate, to invite the Commissioner-designate to a discussion; (c) if the committee responsible for legal affairs identifies a conflict of interests based on the declaration of financial interests or the supplementary information supplied by the Commissioner-designate, it shall draw up recommendations aimed at resolving the conflict of interests; the recommendations may include renouncing the financial interests in question or changes to the portfolio of the Commissioner-designate by the President of the Commission; in more serious cases, if no solution is found to the conflict of interests, and as a last resort, the committee responsible for legal affairs may conclude that the Commissioner-designate is unable to exercise his or her functions in accordance with the Treaties and the Code of Conduct; the President of Parliament shall then ask the President of the Commission what further steps the latter intends to take. Article 3 Hearings 1. Each Commissioner-designate shall be invited to appear before the appropriate committee or committees for a single hearing. 2. The hearings shall be organised by the Conference of Presidents on a recommendation of the Conference of Committee Chairs. The Chair and coordinators of each committee shall be responsible for the detailed arrangements. Rapporteurs may be appointed. 3. Appropriate arrangements shall be made to associate relevant committees where portfolios are mixed. There are three options: (a) if the portfolio of the Commissioner-designate falls within the remit of a single committee, the Commissioner-designate shall be heard by that committee alone (the committee responsible); (b) if the portfolio of the Commissioner-designate falls more or less equally within the remit of more than one committee, the Commissioner-designate shall be heard jointly by those committees (joint committees); and (c) if the portfolio of the Commissioner-designate falls mainly within the remit of one committee and only to a small extent within the remit of at least one other committee, the Commissioner-designate shall be heard by the committee mainly responsible, with the association of the other committee or committees (associated committees). 4. The President-elect of the Commission shall be fully consulted on the arrangements. 5. The committees shall submit written questions to the Commissioners-designate in good time before the hearings. For each Commissioner-designate there shall be two common questions drafted by the Conference of Committee Chairs, the first relating to the issues of general competence, European commitment and personal independence, and the second relating to the management of the portfolio and cooperation with Parliament. The committee responsible shall submit five other questions; sub-questions shall not be allowed. In the case of joint committees, they shall each be given the right to submit three questions. The curriculum vitae of the Commissioners-designate and their response to the written questions shall be published on Parliament's website in advance of the hearing. 6. Each hearing shall be scheduled to last three hours. Hearings shall take place in circumstances, and under conditions, in which Commissioners-designate enjoy an equal and fair opportunity to present themselves and their opinions. 7. Commissioners-designate shall be invited to make an opening oral statement of no longer than 15 minutes. Up to 25 questions, grouped together by theme whenever possible, shall be put during the course of the hearing. One follow up question may be asked immediately within the allocated time. The bulk of the speaking time shall be allotted to political groups, mutatis mutandis in accordance with Rule 171. The conduct of the hearings shall aim to develop a pluralistic political dialogue between the Commissioners-designate and the Members. Before the end of the hearing, the Commissioners-designate shall be given the opportunity to make a brief closing statement. 8. There shall be a live audio-visual transmission of the hearings made available free of charge to the public and media. An indexed recording of the hearings shall be made available to the public within 24 hours. Article 4 Evaluation 1. The Chair and coordinators shall meet without delay after the hearing to evaluate the individual Commissioners-designate. Those meetings shall be held in camera. The coordinators shall be invited to state whether, in their opinion, the Commissioners-designate are qualified both to be members of the College and to carry out the particular duties they have been assigned. The Conference of Committee Chairs shall design a pro forma template to assist the evaluation. 2. In the case of joint committees the Chair and the coordinators of the committees concerned shall act jointly throughout the procedure. 3. There shall be a single evaluation letter for each Commissioner-designate. The opinions of all the committees associated with the hearing shall be included. 4. The following principles shall apply to the coordinators' evaluation: (a) If the coordinators unanimously approve the Commissioner-designate, the Chair shall submit a letter of approval on their behalf. (b) If the coordinators unanimously reject the Commissioner-designate, the Chair shall submit a letter of rejection on their behalf. (c) If coordinators representing a majority of at least two-thirds of the committee membership approve the Commissioner-designate, the Chair shall submit a letter on their behalf stating that a large majority approve the Commissioner-designate. Minority views shall be mentioned upon request. (d) If coordinators cannot reach a majority of at least two-thirds of the committee membership to approve the candidate, they shall — first request additional information through further written questions, — if coordinators are still dissatisfied, request a resumed hearing of 1,5 hours subject to the approval of the Conference of Presidents; (e) If, further to the application of point (d), coordinators representing a majority of at least two-thirds of the committee membership approve the Commissioner-designate, the Chair shall submit a letter on their behalf stating that a large majority approve the Commissioner-designate. Minority views shall be mentioned upon request. (f) If, further to the application of point (d), there is still no majority of coordinators representing at least two-thirds of the committee membership to approve the Commissioner-designate, the Chair shall convene a committee meeting and put to vote the two questions mentioned in paragraph 1. The Chair shall submit a letter stating the committee's evaluation. 5. The committees' letters of evaluation shall be transmitted within 24 hours after the completion of the evaluation process. The letters shall be examined by the Conference of Committee Chairs and conveyed subsequently to the Conference of Presidents. Unless it decides to seek further information, the Conference of Presidents, following an exchange of views, shall declare the hearings closed and authorise the publication of all letters of evaluation. Article 5 Presentation of the college 1. The President-elect of the Commission shall be invited to present the whole College of Commissioners-designate and their programme at a sitting of Parliament which the President of the European Council and the President of the Council shall be invited to attend. The presentation shall be followed by a debate. In order to wind up the debate, a political group or Members reaching at least the low threshold may table a motion for resolution. Rule 132(3) to (8) shall apply. 2. Following the vote on the motion for resolution, Parliament shall vote on whether or not to give its consent to the appointment, as a body, of the President-elect and Commissioners-designate. Parliament shall decide by a majority of the votes cast, by roll call. It may defer the vote until the following sitting. Article 6 Monitoring of commitments made during the hearings The commitments made and priorities referred to by Commissioners-designate during the hearings shall be reviewed, throughout his or her mandate, by the committee responsible in the context of the annual structured dialogue with the Commission undertaken in accordance with paragraph 1 of Annex 4 to the Framework Agreement on relations between the European Parliament and the European Commission. Part II — Substantial portfolio change or change in the composition of the College of Commissioners during its term of office Article 7 Vacancy When a vacancy caused by resignation, compulsory retirement or death is to be filled, Parliament, acting with dispatch, shall invite the Commissioner-designate to participate in a hearing under the same conditions as those laid down in Part I. Article 8 Accession of a new Member State In the event of the accession of a new Member State, Parliament shall invite the Commissioner-designate to participate in a hearing under the same conditions as those laid down in Part I. Article 9 Substantial portfolio change In the event of a substantial portfolio change during the Commission's term of office, the Commissioners affected shall be invited to participate in a hearing under the same conditions as those laid down in Part I before taking up their new responsibilities Article 10 Vote in plenary By way of derogation from the procedure laid down in Rule 125(7), when the vote in plenary concerns the appointment of a single Commissioner, the vote shall be by secret ballot. ANNEX VIII REQUIREMENTS FOR THE DRAFTING OF ACTS ADOPTED IN ACCORDANCE WITH THE ORDINARY LEGISLATIVE PROCEDURE 1. Acts shall indicate the type of the act followed by the reference number, the names of both institutions which adopted it, the date of their signature and an indication of their subject-matter. 2. Acts shall contain the following: (a) ‘The European Parliament and the Council of the European Union’; (b) a reference to the provisions under which the act is adopted, preceded by the words ‘Having regard to’; (c) a citation containing a reference to proposals submitted, opinions obtained and consultations held; (d) a statement of the reasons on which the act is based, introduced by the word ‘Whereas’; (e) a phrase such as ‘have adopted this Regulation’ or ‘have adopted this Directive’ or ‘have adopted this Decision’, followed by the body of the act. 3. Acts shall be divided into articles, if appropriate grouped into parts, titles, chapters and sections. 4. The last article of an act shall specify the date of entry into force, where that date is before or after the twentieth day following publication. 5. The last article of an act shall be followed by: — the appropriate formulation, according to the relevant provisions of the Treaties, as to its applicability, — ‘Done at …’, followed by the date on which the act was signed, — ‘For the European Parliament The President’, ‘For the Council The President’, followed by the name of the President of Parliament and of the President-in-Office of the Council at the time when the act was signed.

European Parliament Rules of Procedure European Parliament Rules of Procedure SUMMARY OF: Rules of Procedure — 9th parliamentary term WHAT IS THE AIM OF THE RULES? They establish the internal organisation and workings of the EU’s only pan-European directly-elected institution. Under Article 232 of the Treaty on the Functioning of the European Union, the European Parliament has the power to adopt its own Rules of Procedure. The document covers all procedural aspects of parliamentary works. KEY POINTS The rules cover the following aspects of parliamentary life: Members of the European Parliament (MEPs): must exercise their mandate independently; enjoy certain privileges and immunities; must respect the MEPs’ statute and several other legal obligations, including rules on the transparency of their financial interests. Parliamentary officers MEPs elect the President, 14 Vice-Presidents and 5 Questors by secret ballot for a term of 2.5 years. The President: has overall direction of the Parliament and its various operations;represents Parliament;ensures observance of the rules and maintains order;opens, suspends and closes sittings, chairs the debates and supervises voting;rules on the admissibility of amendments, of other texts put to the vote and of parliamentary questions; andrefers to parliamentary committees matters that concern them. Vice-Presidents have specific responsibilities and replace the President when necessary. Questors are responsible for administrative and financial matters directly concerning MEPs. The Bureau consists of the President and 14 Vice-Presidents. It decides on financial, organisational and administrative matters affecting the Parliament. The Conference of Presidents consists of the President and the Chairs of the political groups (see below). It organises the Parliament’s political work and decides legislative planning. The Conference of Committee Chairs consists of the chairs of all standing and special parliamentary committees. It may make recommendations on committee work and plenary session agendas. The Conference of Delegation Chairs consists of the chairs of all Parliament delegations to parliaments elsewhere in the world. It may make recommendations on the work of delegations. Political groups are formed by MEPs on the basis of their political affinities. A minimum of 23 MEPs, elected in at least a quarter of EU Member States, is required to form a group. They receive financial and administrative support depending on their size. Some MEPs do not belong to a political group. They receive support for their parliamentary activities.Individual MEPs from different political groups may form a cross-party intergroup on specific issues such as animal welfare or public health. Legislative procedures ordinary legislative procedures (1st, 2nd and 3rd readings), where Parliament acts as co-legislator with the Council; consultation procedures, where Parliament submits an opinion on a draft legal act; consent procedures, where Parliament’s agreement is necessary before adoption of a legal act. In the course of those legislative procedures, Parliament pays specific attention to issues like the respect for fundamental rights, the legal basis, the delegation of legislative powers, the financial compatibility and the respect for subsidiarity. Own-initiative procedures In the case of legislative own-initiative reports, Parliament requests the European Commission to submit proposals (Rule 47) or submits proposals in the cases provided for by the Treaties (Rule 46). Non-legislative reports Parliament can also prepare non-legislative own-initiative reports on specific subject matters: Constitutional matters, where rules cover the Parliament’s role when the EU’s treaties are amended, a new country joins the EU or an EU Member State decides to leave the EU. Budgetary procedures, where rules cover both the consideration of the annual EU budget and its multiannual financial framework. International agreements, where the Parliament’s approval or opinion is required for international agreements. It may also be consulted on aspects of the EU’s common foreign and security policy. Relations with other EU institutions and bodies The Parliament: elects the Commission President and the whole Commission; may adopt a motion of censure against the Commission; is involved in appointments to institutions like the European Central Bank and the Court of Auditors. Parliamentary questions MEPs may table written questions to the: the Council; the Commission; or the Vice-President of the Commission/High Representative of the Union for Foreign Affairs and Security Policy. They can also table oral questions, which are followed by a debate, to the Council or the Commission. Relations with national parliaments Parliament keeps national parliaments regularly informed of its activities. MEPs and national MPs meet occasionally in the Conference of Parliamentary Committees for Union Affairs. Sessions of Parliament Parliament holds 4-day plenary part-sessions 12 times a year in Strasbourg and additional part-sessions in Brussels. Detailed rules cover issues such as: speaking time;use of languages;distribution of documents;voting. Committees Standing committees prepare Parliament’s decisions at plenary level by submitting reports and other documents in their specific field of competence. Special committees may be established for a given term and a specific subject area. Committees of inquiry may be set up to investigate alleged contraventions of EU law or possible maladministration. Interparliamentary delegations Parliament establishes joint committees with national parliaments around the world and cooperates with the Parliamentary Assembly of the Council of Europe. Petitions Any EU citizen may address a petition to Parliament on a matter which comes within the EU’s fields of activity and which affects the petitioner directly. DATE OF ENTRY INTO FORCE They entered into force on 2 July 2019. BACKGROUND For the latest iteration of the rules of procedure, see: Rules of Procedure of the European Parliament (European Parliament) For more information, see: Compendium of the main legal acts related to the Rules of Procedure (European Parliament). MAIN DOCUMENTS Rules of Procedure — 9th parliamentary term — July 2019 (OJ L 302, 22.11.2019, pp. 1-128) Rules of Procedure of the European Parliament 9th parliamentary term — June 2020 last update 03.07.2020

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21.12.2018 EN Official Journal of the European Union L 328/82 DIRECTIVE (EU) 2018/2001 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 on the promotion of the use of energy from renewable sources (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 194(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Directive 2009/28/EC of the European Parliament and of the Council (4) has been substantially amended several times (5). Since further amendments are to be made, that Directive should be recast in the interests of clarity. (2) In accordance with Article 194(1) of the Treaty on the Functioning of the European Union (TFEU), promoting renewable forms of energy is one of the goals of the Union energy policy. That goal is pursued by this Directive. The increased use of energy from renewable sources or ‘renewable energy’ constitutes an important part of the package of measures needed to reduce greenhouse gas emissions and comply with the Union's commitment under the 2015 Paris Agreement on Climate Change following the 21st Conference of the Parties to the United Nations Framework Convention on Climate Change (the ‘Paris Agreement’), and with the Union 2030 energy and climate framework, including the Union's binding target to cut emissions by at least 40 % below 1990 levels by 2030. The Union's binding renewable energy target for 2030 and Member States' contributions to that target, including their baseline shares in relation to their national overall targets for 2020, are among the elements which have an overarching importance for the Union's energy and environmental policy. Other such elements are contained in the framework set out in this Directive, for instance, for the development of renewable heating and cooling and the development of renewable transport fuels. (3) The increased use of energy from renewable sources also has a fundamental part to play in promoting the security of energy supply, sustainable energy at affordable prices, technological development and innovation as well as technological and industrial leadership while providing environmental, social and health benefits as well as major opportunities for employment and regional development, especially in rural and isolated areas, in regions or territories with low population density or undergoing partial deindustrialisation. (4) In particular, reducing energy consumption, increasing technological improvements, incentives for the use and expansion of public transport, the use of energy efficiency technologies and the promotion of the use of renewable energy in the electricity sector, the heating and cooling sector and the transport sector are effective tools, together with energy efficiency measures, for reducing greenhouse gas emissions in the Union and the Union's energy dependence. (5) Directive 2009/28/EC established a regulatory framework for the promotion of the use of energy from renewable sources which set binding national targets on the share of renewable energy in energy consumption and in the transport sector to be met by 2020. The Commission Communication of 22 January 2014 entitled ‘A policy framework for climate and energy in the period from 2020 to 2030’, established a framework for future Union energy and climate policies and promoted a common understanding of how to develop those policies after 2020. The Commission proposed that the Union 2030 target for the share of renewable energy consumed in the Union should be at least 27 %. That proposal was endorsed by the European Council in its conclusions of 23 and 24 October 2014, which indicated that Member States should be able to set their own, more ambitious, national targets in order to deliver their planned contributions to the Union 2030 target and exceed them. (6) In its resolutions of 5 February 2014 entitled ‘A 2030 framework for climate and energy policies’ and of 23 June 2016 entitled ‘The renewable energy progress report’, the European Parliament went further than the Commission proposal or the European Council conclusions, stressing that, in light of the Paris Agreement and the recent renewable technology cost reductions, it was desirable to be significantly more ambitious. (7) The ambition set out in the Paris Agreement as well as technological developments, including cost reductions for investments in renewable energy, should therefore be taken into account. (8) It is thus appropriate to establish a binding Union target of a share of at least 32 % of renewable energy. Moreover, the Commission should assess whether that target should be reviewed upwards in light of substantial cost reductions in the production of renewable energy, the Union's international commitments for decarbonisation, or in the case of a significant decrease in energy consumption in the Union. Member States should establish their contribution to the achievement of that target as part of their integrated national energy and climate plans pursuant to the governance process laid down in Regulation (EU) 2018/1999 of the European Parliament and of the Council (6). (9) The establishment of a binding Union renewable energy target for 2030 would continue to encourage the development of technologies which produce renewable energy and provide certainty for investors. A target defined at Union level would leave greater flexibility for Member States to meet their greenhouse gas reduction targets in the most cost-effective manner in accordance with their specific circumstances, energy mix and capacity to produce renewable energy. (10) In order to ensure consolidation of the results achieved under Directive 2009/28/EC, the national targets set for 2020 should constitute Member States' minimum contributions to the new 2030 framework. Under no circumstances should the national shares of renewable energy fall below those contributions. If they do, the relevant Member States should take appropriate measures as provided for in Regulation (EU) 2018/1999 to ensure that that baseline share is regained. If a Member State does not maintain its baseline share over a 12-month period, it should, within 12 months of the end of that period, take additional measures to regain that baseline share. Where a Member State has effectively taken such additional measures and has fulfilled its obligation to regain the baseline share, it should be deemed to have complied with the mandatory baseline share requirements under this Directive and under Regulation (EU) 2018/1999 for the entire period in question. The Member State in question cannot therefore be considered to have failed to fulfil its obligation to maintain its baseline share for the period in time where the gap occurred. Both the 2020 and 2030 frameworks serve the environmental and energy policy objectives of the Union. (11) Member States should take additional measures in the event that the share of renewable energy at Union level does not meet the Union trajectory towards the renewable energy target of at least 32 %. Under Regulation (EU) 2018/1999 the Commission may take measures at Union level in order to ensure achievement of the target if an ambition gap is identified by the Commission during the assessment of the integrated national energy and climate plans. If the Commission identifies a delivery gap during its assessment of the integrated national energy and climate progress reports, Member States should apply the measures provided for in Regulation (EU) 2018/1999 to close that gap. (12) In order to support Member States' ambitious contributions to the Union target, a financial framework aiming to facilitate investments in renewable energy projects in those Member States should be established, including through the use of financial instruments. (13) The Commission should focus the allocation of funds on the reduction of the cost of capital of renewable energy projects since such cost has a material impact on the cost of renewable energy projects and on their competitiveness, as well as on the development of essential infrastructure for an enhanced technically feasible and economically affordable uptake of renewable energy such as transmission and distribution grid infrastructure, intelligent networks and interconnections. (14) The Commission should facilitate the exchange of best practices between the competent national or regional authorities or bodies, for instance through regular meetings, to find a common approach to promote a higher uptake of cost-efficient renewable energy projects. The Commission should also encourage investments in new, flexible and clean technologies, and establish an adequate strategy to manage the retirement of technologies which do not contribute to the reduction of emissions or deliver sufficient flexibility, based on transparent criteria and reliable market price signals. (15) Regulation (EC) No 1099/2008 of the European Parliament and of the Council (7), Directives 2001/77/EC (8) and 2003/30/EC (9) of the European Parliament and of the Council, and Directive 2009/28/EC established definitions for different types of energy from renewable sources. Union law on the internal market for energy establishes definitions for the electricity sector in general. In the interests of clarity and legal certainty it is appropriate to apply those definitions in this Directive. (16) Support schemes for electricity from renewable sources or ‘renewable electricity’ have been demonstrated to be an effective way of fostering deployment of renewable electricity. If and when Member States decide to implement support schemes, such support should be provided in a form that is as non-distortive as possible for the functioning of electricity markets. To that end, an increasing number of Member States allocate support in a form by means of which support is granted in addition to market revenues and introduce market-based systems to determine the necessary level of support. Together with steps by which to make the market fit for increasing shares of renewable energy, such support is a key element of increasing the market integration of renewable electricity, while taking into account the different capabilities of small and large producers to respond to market signals. (17) Small-scale installations can be of great benefit to increase public acceptance and to ensure the rollout of renewable energy projects, in particular at local level. In order to ensure participation of such small-scale installations, specific conditions, including feed-in tariffs, might therefore still be necessary to ensure a positive cost-benefit ratio, in accordance with Union law relating to the electricity market. The definition of small-scale installations for the purposes of obtaining such support is important to provide legal certainty for investors. State aid rules contain definitions of small-scale installations. (18) Pursuant to Article 108 TFEU, the Commission has exclusive competence to assess the compatibility of State aid measures with the internal market which the Member States may put in place for deployment of energy from renewable sources. That assessment is carried out on the basis of Article 107(3) TFEU and in accordance with the relevant provisions and guidelines which the Commission may adopt to that effect. This Directive is without prejudice to the Commission's exclusive competence granted by the TFEU. (19) Electricity from renewable sources should be deployed at the lowest possible cost to consumers and taxpayers. When designing support schemes and when allocating support, Member States should seek to minimise the overall system cost of deployment along the decarbonisation pathway towards the objective of a low-carbon economy by the year 2050. Market-based mechanisms, such as tendering procedures, have been demonstrated to reduce support cost effectively in competitive markets in many circumstances. However, in specific circumstances, tendering procedures may not necessarily lead to efficient price discovery. Balanced exemptions may therefore need to be considered to ensure cost-effectiveness and minimise overall support cost. In particular, Member States should be allowed to grant exemptions from tendering procedures and direct marketing to small-scale installations and demonstration projects in order to take into account their more limited capabilities. Since the Commission assesses the compatibility of support for renewable energy with the internal market on a case-by-case basis, such exemptions should comply with the relevant thresholds set out in the latest Commission Guidelines on State aid for environmental protection and energy. In the Guidelines for 2014 to 2020, those thresholds are set at 1 MW (and 6 MW or 6 generation units for wind energy) and 500 kW (and 3 MW or 3 generation units for wind energy) in terms of exemptions from, respectively, tendering procedures and direct marketing. To increase the effectiveness of tendering procedures to minimise overall support costs, tendering procedures should, in principle, be open to all producers of electricity from renewable sources on a non-discriminatory basis. While Member States develop their support schemes, they may limit tendering procedures to specific technologies where this is needed to avoid sub-optimal results with regard to network constraints and grid stability, system integration costs, the need to achieve diversification of the energy mix, and the long-term potential of technologies. (20) In its conclusions of 23 and 24 October 2014 on the ‘2030 Climate and Energy Policy Framework’, the European Council stressed the importance of a more interconnected internal energy market and the need for sufficient support to integrate ever increasing levels of variable renewable energy and thus allow the Union to fulfil its leadership ambitions for the energy transition. It is therefore important and urgent to increase the level of interconnection and to make progress towards the European Council's objectives, in order to maximise the Energy Union's full potential. (21) When developing support schemes for renewable sources of energy, Member States should consider the available sustainable supply of biomass and take due account of the principles of the circular economy and of the waste hierarchy established in Directive 2008/98/EC of the European Parliament and of the Council (10) in order to avoid unnecessary distortions of raw materials markets. Waste prevention and recycling of waste should be the priority option. Member States should avoid creating support schemes which would be counter to targets on treatment of waste and which would lead to the inefficient use of recyclable waste. (22) Member States have different renewable energy potentials and operate different support schemes at national level. The majority of Member States apply support schemes that grant benefits solely to energy from renewable sources that is produced on their territory. For the proper functioning of national support schemes, it is vital that Member States continue to be able to control the effect and costs of their national support schemes in accordance with their different potentials. One important means by which to achieve the aim of this Directive remains to guarantee the proper functioning of national support schemes under Directives 2001/77/EC and 2009/28/EC, in order to maintain investor confidence and allow Member States to design effective national measures for their respective contributions to the Union's 2030 target for renewable energy and for the national targets that they have set for themselves. This Directive should facilitate cross-border support for renewable energy without affecting national support schemes in a disproportionate manner. (23) The opening of support schemes to cross-border participation limits negative impacts on the internal energy market and can, under certain conditions, help Member States achieve the Union target more cost-efficiently. Cross-border participation is also the natural corollary to the development of the Union renewable energy policy, fostering convergence and cooperation to contribute to the Union's binding target. It is therefore appropriate to encourage Member States to open support to projects located in other Member States, and define several ways in which such progressive opening may be implemented, ensuring compliance with the TFEU, in particular Articles 30, 34 and 110 thereof. As electricity flows cannot be traced, it is appropriate to link the opening of support schemes to cross-border participation to shares representing an aspiration towards actual levels of physical interconnection and to allow Member States to restrict their open support schemes to Member States with which they have a direct network connection as a practical proxy for demonstrating the existence of physical flows between the Member States. This should not, however, in any way affect the cross-zonal or cross-border functioning of the electricity markets. (24) In order to ensure that the opening of support schemes is reciprocal and brings mutual benefits, cooperation agreements should be signed between participating Member States. Member States should retain control over the pace of deployment of renewable electricity capacity on their territory in order, in particular, to take account of associated integration costs and required grid investments. Member States should thus be allowed to limit the participation of installations located on their territory to tenders opened to them by other Member States. Those cooperation agreements should address all relevant aspects, such as accounting for costs relating to a project built by one Member State on the territory of another, including the expenditure relating to strengthening networks, energy transfer, storage and back-up capacity, as well as possible congestions in the network. In those agreements Member States should also take into account measures that may allow for the cost-effective integration of such additional renewable electricity capacity, whether they are of a regulatory nature (for instance related to market design) or provide for additional investments in various sources of flexibility (for instance interconnections, storage, demand response or flexible generation). (25) Member States should avoid distortive situations resulting in the extensive importation of resources from third countries. A life-cycle approach should be considered and promoted in that respect. (26) Member States should ensure that renewable energy communities can participate in available support schemes on an equal footing with large participants. To that end, Member States should be allowed to take measures, such as providing information, providing technical and financial support, reducing administrative requirements, including community-focused bidding criteria, creating tailored bidding windows for renewable energy communities, or allowing renewable energy communities to be remunerated through direct support where they comply with requirements of small installations. (27) The planning of the infrastructure needed for the production of electricity from renewable sources should take into account policies relating to the participation of those affected by the projects, in particular local populations. (28) Consumers should be provided with comprehensive information, including information on the energy performance of heating and cooling systems and on the lower running costs of electric vehicles, to allow them to make individual consumer choices with regard to renewable energy and avoid technology lock-in. (29) Without prejudice to Articles 107 and 108 TFEU, policies supporting renewable energy should be predictable and stable and should avoid frequent or retroactive changes. Policy unpredictability and instability have a direct impact on capital financing costs, on the costs of project development and therefore on the overall cost of deploying renewable energy in the Union. Member States should prevent the revision of any support granted to renewable energy projects from having a negative impact on their economic viability. In that context, Member States should promote cost-effective support policies and ensure their financial sustainability. Moreover, a long-term indicative schedule covering the main aspects of the expected support should be published, without affecting the ability of Member States to decide on budget allocation in the years covered by the schedule. (30) Member States' obligations to draft renewable energy action plans and progress reports and the Commission's obligation to report on Member States' progress are essential in order to increase transparency, provide clarity to investors and consumers and allow for effective monitoring. Regulation (EU) 2018/1999 integrates those obligations in the Energy Union governance system, where planning, reporting and monitoring obligations in the energy and climate fields are streamlined. The transparency platform on renewable energy is also integrated in the broader e-platform established in that Regulation. (31) It is necessary to provide for transparent and unambiguous rules for calculating the share of energy from renewable sources and for defining those sources. (32) In calculating the contribution of hydropower and wind power for the purposes of this Directive, the effects of climatic variation should be smoothed through the use of a normalisation rule. Further, electricity produced in pumped storage units from water that has previously been pumped uphill should not be considered to be renewable electricity. (33) In order to function, heat pumps enabling the use of ambient and geothermal energy at a useful temperature level or systems providing cooling need electricity or other auxiliary energy. The energy used to drive those systems should therefore be deducted from the total usable energy or energy removed from the area. Only heating and cooling systems where the output or energy removed from an area significantly exceeds the primary energy needed to drive them should be taken into account. Cooling systems contribute to energy use in Member States and it is therefore appropriate that the calculation methods take into account the share of renewable energy used in such systems in all end-use sectors. (34) Passive energy systems use building design to harness energy. This is considered to be saved energy. To avoid double counting, energy harnessed in this way should not be taken into account for the purposes of this Directive. (35) Some Member States have a large share of aviation in their gross final consumption of energy. In view of the current technological and regulatory constraints that prevent the commercial use of biofuels in aviation, it is therefore appropriate to provide those Member States with a partial exemption within the calculation of the gross final consumption of energy in the national air transport sector in order to allow them to exclude from that calculation the amount by which they exceed one-and-a-half times the Union average gross final consumption of energy in aviation in 2005, as assessed by Eurostat, namely, 6,18 %. Due to their insular and peripheral character, Cyprus and Malta rely in particular on aviation as a mode of transport, which is essential for their citizens and their economy. As a result, their gross final consumption of energy in the national air transport sector is disproportionally high, namely, more than three times the Union average in 2005. They are thus disproportionately affected by the current technological and regulatory constraints. It is therefore appropriate to provide that they benefit from an exemption covering the amount by which they exceed the Union average gross final consumption of energy in aviation in 2005 as assessed by Eurostat, namely, 4,12 %. (36) The communication of the Commission of 20 July 2016 entitled ‘A European Strategy for Low-Emission Mobility’, highlighted the particular importance, in the medium term, of advanced biofuels and renewable liquid and gaseous fuels of non-biological origin for aviation. (37) In order to ensure that the list of feedstock to produce advanced biofuels, other biofuels and biogas, as set out in an annex to this Directive, takes into account the principles of the waste hierarchy established in Directive 2008/98/EC, the Union sustainability criteria, and the need to ensure that that annex does not create additional demand for land while promoting the use of wastes and residues, the Commission, when regularly evaluating that annex, should consider the inclusion of additional feedstock that does not cause significant distortive effects on markets for (by-)products, wastes or residues. (38) To create opportunities for reducing the cost of meeting the Union target laid down in this Directive and to give flexibility to Member States to comply with their obligation not to fall below their 2020 national targets after 2020, it is appropriate both to facilitate the consumption in Member States of energy produced from renewable sources in other Member States, and to enable Member States to count energy from renewable sources consumed in other Member States towards their own renewable energy share. For that reason, the Commission should put in place a Union renewable development platform (‘URDP’), enabling trading renewable energy shares between Member States, in addition to bilateral cooperation agreements. The URDP is intended to complement the voluntary opening of support schemes to projects located in other Member States. The agreements between Member States include statistical transfers, joint projects between Member States or joint support schemes. (39) Member States should be encouraged to pursue all appropriate forms of cooperation in relation to the objectives set out in this Directive and to inform citizens about the benefits stemming from the use of cooperation mechanisms. Such cooperation can take place at all levels, bilaterally or multilaterally. Apart from the mechanisms which have an effect on target renewable energy share calculation and target compliance, and which are exclusively provided for in this Directive, namely statistical transfers between Member States –whether put in place bilaterally or through the URDP – joint projects and joint support schemes, cooperation can also take the form of, for example, exchanges of information and best practices, as provided for, in particular, in the e-platform established by Regulation (EU) 2018/1999, and other voluntary coordination between all types of support schemes. (40) It should be possible for imported electricity produced from renewable sources outside the Union to count towards Member States' renewable energy shares. In order to guarantee an adequate effect of renewable energy replacing non-renewable energy in the Union as well as in third countries, it is appropriate to ensure that such imports can be tracked and accounted for in a reliable way. Agreements with third countries concerning the organisation of such trade in renewable electricity will be considered. If, by virtue of a decision taken under the Energy Community Treaty (11) to that effect, the contracting parties thereto are bound by the relevant provisions of this Directive, the measures of cooperation between Member States provided for in this Directive should be applicable to them. (41) When Member States undertake joint projects with one or more third countries regarding the production of renewable electricity, it is appropriate that those joint projects relate only to newly constructed installations or to installations with newly increased capacity. This will help ensure that the proportion of energy from renewable sources in the third country's total energy consumption is not reduced due to the importation of energy from renewable sources into the Union. (42) In addition to establishing a Union framework for the promotion of energy from renewable sources, this Directive also contributes to the potential positive impact which the Union and the Member States can have in boosting the development of the renewable energy sector in third countries. The Union and the Member States should promote research, development and investment in the production of renewable energy in developing and other partner countries while fully respecting international law, thereby strengthening their environmental and economic sustainability and their export capacity of renewable energy. (43) The procedure used for the authorisation, certification and licensing of renewable energy plants should be objective, transparent, non-discriminatory and proportionate when applying the rules to specific projects. In particular, it is appropriate to avoid any unnecessary burden that could arise by classifying renewable energy projects under installations which represent a high risk to health. (44) For the benefit of the rapid deployment of energy from renewable sources and in view of their overall high sustainable and environmental beneficial quality, Member States should, when applying administrative rules or planning structures and legislation which are designed for licensing installations with respect to pollution reduction and control of industrial plants, for combating air pollution, or for the prevention or minimisation of the discharge of dangerous substances in the environment, take into account the contribution of energy from renewable sources towards meeting environmental and climate change objectives, in particular when compared to non-renewable energy installations. (45) The coherence between the objectives of this Directive and the Union's other environmental law should be ensured. In particular, during assessment, planning or licensing procedures for renewable energy installations, Member States should take account of all Union environmental law and the contribution made by energy from renewable sources towards meeting environmental and climate change objectives, in particular when compared to non-renewable energy installations. (46) Geothermal energy is an important local renewable energy source which usually has considerably lower emissions than fossil fuels, and certain types of geothermal plants produce near-zero emission. However, depending on the geological characteristics of an area, the production of geothermal energy may release greenhouse gases and other substances from underground fluids, and other subsoil geological formations, which are harmful for health and the environment. The Commission should therefore facilitate only the deployment of geothermal energy with a low environmental impact and resulting in greenhouse gas emissions savings compared to non-renewable sources. (47) At national, regional and where applicable local level, rules and obligations for minimum requirements for the use of energy from renewable sources in new and renovated buildings have led to considerable increases in the use of energy from renewable sources. Those measures should be encouraged in a wider Union context, while promoting the use of more energy-efficient applications of energy from renewable sources in combination with energy-savings and energy-efficiency measures through building regulations and codes. (48) In order to facilitate and accelerate the setting of minimum levels for the use of energy from renewable sources in buildings, the calculation of those minimum levels in new and existing buildings subject to major renovation should provide a sufficient basis for assessing whether the inclusion of minimum levels of renewable energy is technically, functionally and economically feasible. Member States should allow, inter alia, the use of efficient district heating and cooling or, where district heating and cooling systems are not available, other energy infrastructure to fulfil those requirements. (49) To ensure that national measures for developing renewable heating and cooling are based on comprehensive mapping and analysis of the national renewable and waste energy potential and that such measures provide for increased integration of renewable energy, by supporting, inter alia, innovative technologies such as heat pumps, geothermal and solar thermal technologies, and waste heat and cold, it is appropriate to require that Member States carry out an assessment of their potential of energy from renewable sources and the use of waste heat and cold in the heating and cooling sector, in particular to promote energy from renewable sources in heating and cooling installations and promote competitive and efficient district heating and cooling. To ensure consistency with energy efficiency requirements for heating and cooling and reduce administrative burden, that assessment should be included in the comprehensive assessments carried out and notified in accordance with Article 14 of Directive 2012/27/EU of the European Parliament and of the Council (12). (50) The lack of transparent rules and coordination between the different authorisation bodies has been shown to hinder the deployment of energy from renewable sources. Providing guidance to applicants throughout their administrative permit application and granting processes by means of an administrative contact point is intended to reduce complexity for project developers and increase efficiency and transparency, including for renewables self-consumers and renewable energy communities. Such guidance is to be provided at an appropriate level of governance, taking into account the specificities of Member States. The single contact points should guide the applicant and facilitate through the entire administrative process so that the applicant is not obliged to contact other administrative bodies in order to complete the permit-granting process, unless the applicant prefers to do so. (51) Lengthy administrative procedures constitute a major administrative barrier and are costly. The simplification of administrative permit granting processes, and clear time-limits for decisions to be taken by the authorities competent for issuing the authorisation for the electricity generation installation on the basis of a completed application, should stimulate a more efficient handling of procedures, thereby reducing administrative costs. A manual of procedures should be made available to facilitate the understanding of procedures for project developers and citizens wishing to invest in renewable energy. In order to foster the uptake of renewable energy by microenterprises and small and medium-sized enterprises (SMEs) and individual citizens, in accordance with the objectives set out in this Directive, a simple-notification procedure for grid connections to the competent body should be established for small renewable energy projects, including those that are decentralised, such as rooftop solar installations. In order to respond to the increasing need for the repowering of existing renewable energy plants, streamlined permit-granting procedures should be provided for. This Directive, in particular the provisions on the organisation and duration of the administrative permit granting process, should apply without prejudice to international and Union law, including provisions to protect the environment and human health. Where duly justified on the grounds of extraordinary circumstances, it should be possible to extend the initial timeframes by up to one year. (52) Information and training gaps, especially in the heating and cooling sector, should be removed in order to encourage the deployment of energy from renewable sources. (53) In so far as the access or pursuit of the profession of installer is a regulated profession, the preconditions for the recognition of professional qualifications are laid down in Directive 2005/36/EC of the European Parliament and of the Council (13). This Directive therefore applies without prejudice to Directive 2005/36/EC. (54) While Directive 2005/36/EC lays down requirements for the mutual recognition of professional qualifications, including for architects, there is also a need to ensure that planners and architects properly consider an optimal combination of renewable energy and high-efficiency technologies in their plans and designs. Member States should therefore provide clear guidance in that regard. This should be done without prejudice to that Directive and in particular Articles 46 and 49 thereof. (55) Guarantees of origin issued for the purposes of this Directive have the sole function of showing to a final customer that a given share or quantity of energy was produced from renewable sources. A guarantee of origin can be transferred, independently of the energy to which it relates, from one holder to another. However, with a view to ensuring that a unit of renewable energy is disclosed to a customer only once, double counting and double disclosure of guarantees of origin should be avoided. Energy from renewable sources in relation to which the accompanying guarantee of origin has been sold separately by the producer should not be disclosed or sold to the final customer as energy from renewable sources. It is important to distinguish between green certificates used for support schemes and guarantees of origin. (56) It is appropriate to allow the consumer market for renewable electricity to contribute to the development of energy from renewable sources. Member States should therefore require electricity suppliers who disclose their energy mix to final customers pursuant to Union law on the internal market for electricity, or who market energy to consumers with a reference to the consumption of energy from renewable sources, to use guarantees of origin from installations producing energy from renewable sources. (57) It is important to provide information on how supported electricity is allocated to final customers. In order to improve the quality of that information to consumers, Member States should ensure that guarantees of origin are issued for all units of renewable energy produced, except where they decide not to issue guarantees of origin to producers that also receive financial support. If Member States decide to issue guarantees of origin to producers that also receive financial support or not to issue guarantees of origin directly to producers, they should be able to choose by which means and mechanisms to take into account the market value of those guarantees of origin. Where renewable energy producers also receive financial support, the market value of the guarantees of origin for the same production should be appropriately taken into account in the relevant support scheme. (58) Directive 2012/27/EU provides for guarantees of origin for proving the origin of electricity produced from high-efficiency cogeneration plants. However, no use is specified for such guarantees of origin, so their use may also be enabled when disclosing the use of energy from high-efficiency cogeneration. (59) Guarantees of origin which are currently in place for renewable electricity should be extended to cover renewable gas. Extending the guarantees of origin system to energy from non-renewable sources should be an option for Member States. This would provide a consistent means of proving to final customers the origin of renewable gas such as biomethane and would facilitate greater cross-border trade in such gas. It would also enable the creation of guarantees of origin for other renewable gas such as hydrogen. (60) There is a need to support the integration of energy from renewable sources into the transmission and distribution grid and the use of energy storage systems for integrated variable production of energy from renewable sources, in particular as regards the rules regulating dispatch and access to the grid. The framework for the integration of renewable electricity is provided for in other Union law relating to the internal electricity market. However, that framework does not include provisions on the integration of gas from renewable sources into the gas grid. It is therefore necessary to include such provisions in this Directive. (61) The opportunities for establishing economic growth through innovation and a sustainable competitive energy policy have been recognised. Production of energy from renewable sources often depends on local or regional SMEs. The opportunities for local business development, sustainable growth and high-quality employment that investments in regional and local production of energy from renewable sources bring about in the Member States and their regions are important. The Commission and the Member States should therefore foster and support national and regional development measures in those areas, encourage the exchange of best practices in production of energy from renewable sources between local and regional development initiatives and enhance the provision of technical assistance and training programmes, in order to strengthen regulatory, technical and financial expertise and foster knowledge on available funding possibilities, including a more targeted use of Union funds, such as the use of cohesion policy funding in that area. (62) Regional and local authorities often set more ambitious renewable targets that exceed national targets. Regional and local commitments to stimulating development of renewable energy and energy efficiency are currently supported through networks, such as the Covenant of Mayors, Smart Cities or Smart Communities initiatives, and the development of sustainable energy action plans. Such networks are essential and should be expanded, as they raise awareness and facilitate exchanges of best practices and available financial support. In that context, the Commission should support interested innovative regions and local authorities to work across borders by assisting in setting up cooperation mechanisms, such as the European Grouping of Territorial Cooperation, which enables public authorities of various Member States to collaborate and deliver joint services and projects, without requiring a prior international agreement to be signed and ratified by national parliaments. Other innovative measures to attract more investment into new technologies, such as energy-performance contracts and standardisation processes in public financing, should also be considered. (63) When favouring the development of the market for energy from renewable sources, it is necessary to take into account the positive impact on regional and local development opportunities, export prospects, social cohesion and employment opportunities, in particular as concerns SMEs and independent energy producers, including renewables self-consumers and renewable energy communities. (64) The specific situation of the outermost regions is recognised in Article 349 TFEU. The energy sector in the outermost regions is often characterised by isolation, limited supply and dependence on fossil fuels while those regions benefit from significant local renewable sources of energy. The outermost regions could thus serve as examples of the application of innovative energy technologies for the Union. It is therefore necessary to promote the uptake of renewable energy in order to achieve a higher degree of energy autonomy for those regions and recognise their specific situation in terms of renewable energy potential and public support needs. Provision should be made for a derogation of limited local impact that allows Member States to adopt specific criteria in order to ensure eligibility for financial support for the consumption of certain biomass fuels. Member States should be able to adopt such specific criteria for installations using biomass fuels and located in an outermost region as referred to in Article 349 TFEU, as well as for biomass that is used as fuel in such installations and that does not comply with the harmonised sustainability, energy efficiency and greenhouse gas emissions saving criteria set out in this Directive. Such specific criteria for biomass fuels should apply irrespective of whether the place of origin of that biomass is a Member State or a third country. Moreover, any specific criteria should be objectively justified on the grounds of energy independence of the outermost region concerned and of ensuring a smooth transition to the sustainability criteria, the energy efficiency criteria and the greenhouse gas emissions saving criteria for biomass fuels of this Directive in such an outermost region. Considering that the energy mix for electricity generation for the outermost regions is made up to a large extent of fuel oil, it is necessary to allow an appropriate consideration of greenhouse gas emissions saving criteria in those regions. It would therefore be appropriate to provide for a specific fossil fuel comparator for the electricity produced in the outermost regions. Member States should ensure effective compliance with their specific criteria. Finally, Member States should, without prejudice to support granted in accordance with support schemes in accordance with this Directive, not refuse to take into account, on other sustainability grounds, biofuels and bioliquids obtained in accordance with this Directive. This prohibition is intended to ensure that biofuels and bioliquids that comply with the harmonised criteria provided for in this Directive continue to benefit from the trade facilitation objectives of this Directive, including as regards the outermost regions concerned. (65) It is appropriate to allow for the development of decentralised renewable energy technologies and storage under non-discriminatory conditions and without hampering the financing of infrastructure investments. The move towards decentralised energy production has many benefits, including the utilisation of local energy sources, increased local security of energy supply, shorter transport distances and reduced energy transmission losses. Such decentralisation also fosters community development and cohesion by providing income sources and creating jobs locally. (66) With the growing importance of self-consumption of renewable electricity, there is a need for a definition of ‘renewables self-consumers’ and of ‘jointly acting renewables self-consumers’. It is also necessary to establish a regulatory framework which would empower renewables self-consumers to generate, consume, store, and sell electricity without facing disproportionate burdens. Citizens living in apartments for example should be able to benefit from consumer empowerment to the same extent as households in single family homes. However, Member States should be allowed to differentiate between individual renewables self-consumers and jointly acting renewables self-consumers due to their different characteristics to the extent that any such differentiation is proportionate and duly justified. (67) Empowering jointly acting renewables self-consumers also provides opportunities for renewable energy communities to advance energy efficiency at household level and helps fight energy poverty through reduced consumption and lower supply tariffs. Member States should take appropriate advantage of that opportunity by, inter alia, assessing the possibility to enable participation by households that might otherwise not be able to participate, including vulnerable consumers and tenants. (68) Renewables self-consumers should not face discriminatory or disproportionate burdens or costs and should not be subject to unjustified charges. Their contribution to the achievement of the climate and energy target and the costs and benefits that they bring about in the wider energy system should be taken into account. Member States should therefore generally not apply charges to electricity produced and consumed within the same premises by renewables self-consumers. However, Member States should be allowed to apply non-discriminatory and proportionate charges to such electricity if necessary to ensure the financial sustainability of the electricity system, to limit the support to what is objectively needed and to make efficient use of their support schemes. At the same time, Member States should ensure that renewables self-consumers contribute in a balanced and adequate way to the overall cost-sharing system of producing, distributing and consuming electricity, when electricity is fed into the grid. (69) To that end, Member States should as a general principle not apply charges to electricity individually produced and consumed by renewables self-consumers within the same premises. However, in order to prevent that incentive from affecting the financial stability of support schemes for renewable energy, that incentive could be limited to small installations with an electrical capacity of 30 kW or less. In certain cases, Member States should be allowed to apply charges to renewables self-consumers for self-consumed electricity, where they make efficient use of their support schemes and apply non-discriminatory and effective access to their support schemes. Member States should also be able to apply partial exemptions from charges, levies, or a combination thereof and support, up to the level needed to ensure the economic viability of such projects. (70) The participation of local citizens and local authorities in renewable energy projects through renewable energy communities has resulted in substantial added value in terms of local acceptance of renewable energy and access to additional private capital which results in local investment, more choice for consumers and greater participation by citizens in the energy transition. Such local involvement is all the more crucial in a context of increasing renewable energy capacity. Measures to allow renewable energy communities to compete on an equal footing with other producers also aim to increase the participation of local citizens in renewable energy projects and therefore increase acceptance of renewable energy. (71) The specific characteristics of local renewable energy communities in terms of size, ownership structure and the number of projects can hamper their competition on an equal footing with large-scale players, namely competitors with larger projects or portfolios. Therefore, it should be possible for Member States to choose any form of entity for renewable energy communities, provided that such an entity may, acting in its own name, exercise rights and be subject to obligations. To avoid abuse and to ensure broad participation, renewable energy communities should be capable of remaining autonomous from individual members and other traditional market actors that participate in the community as members or shareholders, or who cooperate through other means such as investment. Participation in renewable energy projects should be open to all potential local members based on objective, transparent and non-discriminatory criteria. Measures to offset the disadvantages relating to the specific characteristics of local renewable energy communities in terms of size, ownership structure and the number of projects include enabling renewable energy communities to operate in the energy system and easing their market integration. Renewable energy communities should be able to share between themselves energy that is produced by their community-owned installations. However, community members should not be exempt from relevant costs, charges, levies and taxes that would be borne by final consumers who are not community members, producers in a similar situation, or where public grid infrastructure is used for those transfers. (72) Household consumers and communities engaging in renewables self-consumption should maintain their rights as consumers, including the rights to have a contract with a supplier of their choice and to switch supplier. (73) Representing around half of the final energy consumption of the Union, the heating and cooling sector is considered to be a key sector in accelerating the decarbonisation of the energy system. Moreover, it is also a strategic sector in terms of energy security, as around 40 % of the renewable energy consumption by 2030 is projected to come from renewable heating and cooling. However, the absence of a harmonised strategy at Union level, the lack of internalisation of external costs and the fragmentation of heating and cooling markets have, to date, led to relatively slow progress in the sector. (74) Several Member States have implemented measures in the heating and cooling sector to reach their 2020 renewable energy target. However, in the absence of binding national targets post-2020, the remaining national incentives may not be sufficient to reach the long-term decarbonisation goals for 2030 and 2050. In order to meet such goals, reinforce investor certainty and foster the development of a Union-wide renewable heating and cooling market, while respecting the energy efficiency first principle, it is appropriate to encourage the efforts of Member States in the supply of renewable heating and cooling to contribute to the progressive increase of the share of renewable energy. Given the fragmented nature of some heating and cooling markets, it is of utmost importance to ensure flexibility in designing such an effort. It is also important to ensure that a potential uptake of renewable heating and cooling does not have detrimental environmental side-effects or lead to disproportionate overall costs. In order to minimise that risk, the increase of the share of renewable energy in the heating and cooling sector should take into account the situation of those Member States where the share is already very high, or where waste heat and cold is not used, such as in Cyprus and Malta. (75) District heating and cooling currently represents around 10 % of the heat demand across the Union, with large discrepancies between Member States. The Commission's heating and cooling strategy has recognised the potential for decarbonisation of district heating through increased energy efficiency and renewable energy deployment. (76) The Energy Union strategy also recognised the role of the citizen in the energy transition, where citizens take ownership of the energy transition, benefit from new technologies to reduce their bills, and participate actively in the market. (77) The potential synergies between an effort to increase the uptake of renewable heating and cooling and the existing schemes under Directive 2010/31/EU of the European Parliament and of the Council (14) and Directive 2012/27/EU should be emphasised. Member States should, to the extent possible, have the possibility to use existing administrative structures to implement such effort, in order to mitigate the administrative burden. (78) In the area of district heating, it is therefore crucial to enable the fuel-switching to energy from renewable sources and prevent regulatory and technology lock-in and technology lock-out through reinforced rights for renewable energy producers and final consumers, and bring the tools to final consumers to facilitate their choice between the highest energy-performance solutions that take into account future heating and cooling needs in accordance with expected building performance criteria. Final consumers should be given transparent and reliable information on the efficiency of district heating and cooling systems and the share of energy from renewable sources in their specific heating or cooling supply. (79) In order to protect consumers of district heating and cooling systems that are not efficient district heating and cooling systems and to allow them to produce their heating or cooling from renewable sources and with significantly better energy performance, consumers should be entitled to disconnect and thus discontinue the heating or cooling service from non-efficient district heating and cooling systems at a whole building level by terminating their contract or, where the contract covers several buildings, by modifying the contract with the district heating or cooling operator. (80) To prepare for the transition towards advanced biofuels and minimise the overall direct and indirect land-use change impacts, it is appropriate to limit the amount of biofuels and bioliquids produced from cereal and other starch-rich crops, sugars and oil crops that can be counted towards the targets laid down in this Directive, without restricting the overall possibility of using such biofuels and bioliquids. The establishment of a limit at Union level should not prevent Member States from providing for lower limits to the amount of biofuels and bioliquids produced from cereal and other starch-rich crops, sugars and oil crops that can be counted at national level towards the targets laid down in this Directive, without restricting the overall possibility of using such biofuels and bioliquids. (81) Directive 2009/28/EC introduced a set of sustainability criteria, including criteria protecting land with high biodiversity value and land with high-carbon stock, but did not cover the issue of indirect land-use change. Indirect land-use change occurs when the cultivation of crops for biofuels, bioliquids and biomass fuels displaces traditional production of crops for food and feed purposes. Such additional demand increases the pressure on land and can lead to the extension of agricultural land into areas with high-carbon stock, such as forests, wetlands and peatland, causing additional greenhouse gas emissions. Directive (EU) 2015/1513 of the European Parliament and of the Council (15) recognises that the magnitude of greenhouse gas emissions-linked indirect land-use change is capable of negating some or all greenhouse gas emissions savings of individual biofuels, bioliquids or biomass fuels. While there are risks arising from indirect land-use change, research has shown that the scale of the effect depends on a variety of factors, including the type of feedstock used for fuel production, the level of additional demand for feedstock triggered by the use of biofuels, bioliquids and biomass fuels, and the extent to which land with high-carbon stock is protected worldwide. While the level of greenhouse gas emissions caused by indirect land-use change cannot be unequivocally determined with the level of precision required to be included in the greenhouse gas emission calculation methodology, the highest risks of indirect land-use change have been identified for biofuels, bioliquids and biomass fuels produced from feedstock for which a significant expansion of the production area into land with high-carbon stock is observed. It is therefore appropriate, in general, to limit food and feed crops-based biofuels, bioliquids and biomass fuels promoted under this Directive and, in addition, to require Member States to set a specific and gradually decreasing limit for biofuels, bioliquids and biomass fuels produced from food and feed crops for which a significant expansion of the production area into land with high-carbon stock is observed. Low indirect land-use change-risk biofuels, bioliquids and biomass fuels should be exempt from the specific and gradually decreasing limit. (82) Yield increases in agricultural sectors by means of improved agricultural practices, investments in better machinery and knowledge transfer, beyond levels which would have prevailed in the absence of productivity-promoting schemes for food and feed crop-based biofuels, bioliquids and biomass fuels, as well as the cultivation of crops on land not previously used for the cultivation of crops, can mitigate indirect land-use change. Where there is evidence that such measures have led to an increase of production going beyond the expected increase in productivity, biofuels, bioliquids and biomass fuels produced from such additional feedstock should be considered to be low indirect land-use change-risk biofuels, bioliquids and biomass fuels. Annual yield fluctuations should be taken into account in that context. (83) Directive (EU) 2015/1513 called on the Commission to submit, without delay, a comprehensive proposal for a cost-effective and technology-neutral post-2020 policy in order to create a long-term perspective for investment in sustainable biofuels with a low risk of causing indirect land-use change with a headline target of decarbonising the transport sector. An obligation on Member States to require fuel suppliers to deliver an overall share of fuels from renewable sources can provide certainty for investors and encourage the continuous development of alternative renewable transport fuels including advanced biofuels, renewable liquid and gaseous transport fuels of non-biological origin, and renewable electricity in the transport sector. Since renewable alternatives might not be available or cost-efficient to all fuel suppliers, it is appropriate to allow Member States to distinguish between fuel suppliers and to exempt, if necessary, particular types of fuel supplier from the obligation. As transport fuels are traded easily, fuel suppliers in Member States with low supplies of the relevant resources are likely easily to obtain renewable fuels from other sources. (84) A Union database should be put in place to ensure transparency and traceability of renewable fuels. While Member States should be allowed to continue to use or establish national databases, those national databases should be linked to the Union database, in order to ensure instant data transfers and harmonisation of data flows. (85) Advanced biofuels and other biofuels and biogas produced from feedstock listed in an annex to this Directive, renewable liquid and gaseous transport fuels of non-biological origin, and renewable electricity in the transport sector can contribute to low carbon emissions, stimulating the decarbonisation of the Union transport sector in a cost-effective manner, and improving, inter alia, energy diversification in the transport sector while promoting innovation, growth and jobs in the Union economy and reducing reliance on energy imports. An obligation on Member States to require fuel suppliers to ensure a minimum share of advanced biofuels and certain biogases, is intended to encourage continuous development of advanced fuels, including biofuels. It is important to ensure that that obligation also promotes improvements in the greenhouse gas performance of the fuels supplied to meet it. The Commission should assess the greenhouse gas performance, technical innovation and sustainability of those fuels. (86) With regard to Intelligent Transport, it is important to increase the development and deployment of electric mobility for road, as well as to accelerate the integration of advanced technologies into innovative rail. (87) Electromobility is expected to constitute a substantial part of the renewable energy in the transport sector by the year 2030. Further incentives should be provided considering the swift development of electromobility and the potential of that sector in terms of growth and jobs in the Union. Multipliers for renewable electricity supplied for the transport sector should be used for the promotion of renewable electricity in the transport sector and in order to reduce the comparative disadvantage in energy statistics. Since it is not possible to account for all electricity supplied for road vehicles in statistics through dedicated metering, such as charging at home, multipliers should be used in order to ensure that the positive impacts of electrified renewable energy-based transport are properly accounted for. Options should be explored to ensure that the new demand for electricity in the transport sector is met with additional generation capacity of energy from renewable sources. (88) In light of climatic constraints that limit the possibility of consuming certain types of biofuels due to environmental, technical or health concerns, and due to the size and structure of their fuel markets, it is appropriate that Cyprus and Malta, for the purposes of demonstrating compliance with national renewable energy obligations placed on fuel suppliers, be allowed to take into account those inherent limitations. (89) The promotion of recycled carbon fuels can contribute towards the policy objectives of energy diversification and decarbonisation of the transport sector where they fulfil the appropriate minimum greenhouse gas emissions savings threshold. It is therefore appropriate to include those fuels in the obligation on fuel supplier, whilst giving Member States the option not to consider those fuels in the obligation if they do not wish to do so. Since those fuels are not renewable, they should not be counted towards the overall Union target for energy from renewable sources. (90) Renewable liquid and gaseous transport fuels of non-biological origin are important to increase the share of renewable energy in sectors that are expected to rely on liquid fuels in the long term. To ensure that renewable fuels of non-biological origin contribute to greenhouse gas reduction, the electricity used for the fuel production should be of renewable origin. The Commission should develop, by means of delegated acts, a reliable Union methodology to be applied where such electricity is taken from the grid. That methodology should ensure that there is a temporal and geographical correlation between the electricity production unit with which the producer has a bilateral renewables power purchase agreement and the fuel production. For example, renewable fuels of non-biological origin cannot be counted as fully renewable if they are produced when the contracted renewable generation unit is not generating electricity. Another example is the case of electricity grid congestion, where fuels can be counted as fully renewable only when both the electricity generation and the fuel production plants are located on the same side in respect of the congestion. Furthermore, there should be an element of additionality, meaning that the fuel producer is adding to the renewable deployment or to the financing of renewable energy. (91) Feedstock which has low indirect land-use change impacts when used for biofuels, should be promoted for its contribution to the decarbonisation of the economy. Feedstock for advanced biofuels and biogas for transport, for which technology is more innovative and less mature and therefore needs a higher level of support, should, in particular, be included in an annex to this Directive. In order to ensure that it is updated in accordance with the latest technological developments while avoiding unintended negative effects, the Commission should review that annex in order to assess whether new feedstock should be added. (92) The costs of connecting new producers of gas from renewable sources to the gas grids should be based on objective, transparent and non-discriminatory criteria and due account should be taken of the benefit that embedded local producers of gas from renewable sources bring to the gas grids. (93) In order to exploit the full potential of biomass, which does not include peat or material embedded in geological formations and/or transformed to fossil, to contribute to the decarbonisation of the economy through its uses for materials and energy, the Union and the Member States should promote greater sustainable mobilisation of existing timber and agricultural resources and the development of new forestry and agriculture production systems, provided that sustainability and greenhouse gas emissions saving criteria are met. (94) Biofuels, bioliquids and biomass fuels should always be produced in a sustainable manner. Biofuels, bioliquids and biomass fuels used for compliance with the Union target laid down in this Directive, and those which benefit from support schemes, should therefore be required to fulfil sustainability and greenhouse gas emissions saving criteria. The harmonisation of those criteria for biofuels and bioliquids is essential for the achievement of the energy policy objectives of the Union as set out in Article 194(1) TFEU. Such harmonisation ensures the functioning of the internal energy market and thus facilitates, especially with regard to the obligation of Member States not to refuse to take into account, on other sustainability grounds, biofuels and bioliquids obtained in accordance with this Directive, trade between Member States in compliant biofuels and bioliquids. The positive effects of the harmonisation of those criteria on the smooth functioning of the internal energy market and on the avoidance of distortion of competition in the Union cannot be frustrated. For biomass fuels, Member States should be allowed to establish additional sustainability and greenhouse gas emissions saving criteria. (95) The Union should take appropriate steps in the context of this Directive, including the promotion of sustainability and greenhouse gas emissions saving criteria for biofuels, and for bioliquids and biomass fuels. (96) The production of agricultural raw material for biofuels, bioliquids and biomass fuels, and the incentives provided for in this Directive to promote their use, should not have the effect of encouraging the destruction of biodiverse lands. Such finite resources, recognised in various international instruments to be of universal value, should be preserved. It is therefore necessary to provide sustainability and greenhouse gas emissions saving criteria ensuring that biofuels, bioliquids and biomass fuels qualify for the incentives only where it is guaranteed that agricultural raw material does not originate from biodiverse areas or, in the case of areas designated for nature protection purposes or for the protection of rare, threatened or endangered ecosystems or species, the relevant competent authority demonstrates that the production of the agricultural raw material does not interfere with such purposes. (97) Forests should be considered to be biodiverse in accordance with the sustainability criteria where they are primary forests in accordance with the definition used by the Food and Agriculture Organisation of the United Nations (FAO) in its Global Forest Resource Assessment, or where they are protected by national nature protection law. Areas where the collection of non-wood forest products occurs should be considered to be biodiverse forests, provided that the human impact is small. Other types of forest as defined by the FAO, such as modified natural forests, semi-natural forests and plantations, should not be considered to be primary forests. Having regard, furthermore, to the highly biodiverse nature of certain grasslands, both temperate and tropical, including highly biodiverse savannahs, steppes, scrublands and prairies, biofuels, bioliquids and biomass fuels made from agricultural raw materials originating in such lands should not qualify for the incentives provided for by this Directive. In order to establish appropriate criteria to define such highly biodiverse grassland in accordance with the best available scientific data and relevant international standards, implementing powers should be conferred on the Commission. (98) Land should not be converted to accommodate the production of agricultural raw material for biofuels, bioliquids and biomass fuels if its carbon stock loss upon conversion could not, within a reasonable period, taking into account the urgency of tackling climate change, be compensated for by the greenhouse gas emission savings resulting from the production and use of biofuels, bioliquids and biomass fuels. This would prevent unnecessary, burdensome research by economic operators and the conversion of high-carbon-stock land that are demonstrated to be ineligible for producing agricultural raw materials for biofuels bioliquids and biomass fuels. Inventories of worldwide carbon stocks indicate that wetlands and continuously forested areas with a canopy cover of more than 30 % should be included in that category. (99) In the framework of the Common Agricultural Policy, Union farmers should comply with a comprehensive set of environmental requirements in order to receive direct support. Compliance with those requirements can be most effectively verified in the context of agricultural policy. Including those requirements in the sustainability scheme is not appropriate as the sustainability criteria for bioenergy should set out rules that are objective and apply globally. Verification of compliance under this Directive would also risk causing an unnecessary administrative burden. (100) Agricultural feedstock for the production of biofuels, bioliquids and biomass fuels should be produced using practices that are consistent with the protection of soil quality and soil organic carbon. Soil quality and soil carbon should therefore be included in monitoring systems of operators or national authorities. (101) It is appropriate to introduce Union-wide sustainability and greenhouse gas emissions saving criteria for biomass fuels used in the electricity sector and in the heating and cooling sector, in order to continue to ensure high greenhouse gas emissions savings compared to fossil fuel alternatives, to avoid unintended sustainability impacts, and to promote the internal market. The outermost regions should be able to use the potential of their resources in order to increase the production of renewable energy and their energy independence. (102) To ensure that, despite the growing demand for forest biomass, harvesting is carried out in a sustainable manner in forests where regeneration is ensured, that special attention is given to areas explicitly designated for the protection of biodiversity, landscapes and specific natural elements, that biodiversity resources are preserved and that carbon stocks are tracked, woody raw material should emanate only from forests that are harvested in accordance with the principles of sustainable forest management that are developed under international forest processes such as Forest Europe and that are implemented through national law or the best management practices at sourcing area level. Operators should take the appropriate steps in order to minimise the risk of using unsustainable forest biomass for the production of bioenergy. To that end, operators should put in place a risk-based approach. In this context, it is appropriate for the Commission to develop operational guidance on the verification of compliance with the risk-based approach by means of implementing acts, after consulting the Committee on the Sustainability of Biofuels, Bioliquids and Biomass fuels. (103) Harvesting for energy purposes has increased and is expected to continue to grow, resulting in higher imports of raw materials from third countries as well as an increase of the production of those materials within the Union. It should be ensured that harvesting is sustainable. (104) In order to minimise the administrative burden, the Union sustainability and greenhouse gas emissions saving criteria should apply only to electricity and heating from biomass fuels produced in installations with a total rated thermal input equal to or exceeding 20 MW. (105) Biomass fuels should be converted into electricity and heat in an efficient way in order to maximise energy security and greenhouse gas emissions savings, as well as to limit emissions of air pollutants and minimise the pressure on limited biomass resources. (106) The minimum greenhouse gas emissions savings threshold for biofuels, bioliquids and biogas for transport produced in new installations should be increased in order to improve their overall greenhouse gas balance and to discourage further investments in installations with a low greenhouse gas emission savings performance. That increase provides investment safeguards for biofuels, bioliquids and biogas for transport production capacity. (107) Based on experience in the practical implementation of the Union sustainability criteria, it is appropriate to strengthen the role of voluntary international and national certification schemes for verification of compliance with the sustainability criteria in a harmonised manner. (108) It is in the interests of the Union to encourage the development of voluntary international or national schemes that set standards for the production of sustainable biofuels, bioliquids and biomass fuels and that certify that the production of biofuels, bioliquids and biomass fuels meets those standards. For that reason, provision should be made for schemes to be recognised as providing reliable evidence and data where they meet adequate standards of reliability, transparency and independent auditing. In order to ensure that compliance with the sustainability and greenhouse gas emissions saving criteria is verified in a robust and harmonised manner and in particular to prevent fraud, the Commission should be empowered to adopt detailed implementing rules, including adequate standards of reliability, transparency and independent auditing to be applied by the voluntary schemes. (109) Voluntary schemes play an increasingly important role in providing evidence of compliance with the sustainability and greenhouse gas emissions saving criteria for biofuels, bioliquids and biomass fuels. It is therefore appropriate for the Commission to require voluntary schemes, including those already recognised by the Commission, to report regularly on their activity. Such reports should be made public in order to increase transparency and to improve supervision by the Commission. Furthermore, such reporting would provide the necessary information for the Commission to report on the operation of the voluntary schemes with a view to identifying best practices and submitting, if appropriate, a proposal to further promote such best practices. (110) To facilitate the functioning of the internal market, evidence regarding the sustainability and greenhouse gas emissions criteria for biofuels, bioliquids and biomass fuels that have been obtained in accordance with a scheme that has been recognised by the Commission should be accepted in all Member States. Member States should contribute towards ensuring the correct implementation of the certification principles of voluntary schemes by supervising the operation of certification bodies that are accredited by the national accreditation body and by informing the voluntary schemes about relevant observations. (111) In order to avoid a disproportionate administrative burden, a list of default values should be laid down for common biofuel, bioliquid and biomass fuel production pathways and that list should be updated and expanded when further reliable data are available. Economic operators should always be entitled to claim the level of greenhouse gas emissions savings for biofuels, bioliquids and biomass fuels established by that list. Where the default value for greenhouse gas emissions savings from a production pathway lies below the required minimum level of greenhouse gas emissions savings, producers wishing to demonstrate their compliance with that minimum level should be required to show that the actual greenhouse gas emissions from their production process are lower than those that were assumed when calculating the default values. (112) It is necessary to lay down clear rules based on objective and non-discriminatory criteria, for the calculation of greenhouse gas emissions savings from biofuels, bioliquids and biomass fuels and their fossil fuel comparators. (113) In accordance with current technical and scientific knowledge, the greenhouse gas emissions accounting methodology should take into account the transformation of solid and gaseous biomass fuels into final energy in order to be consistent with the calculation of renewable energy for the purposes of counting towards the Union target laid down in this Directive. The allocation of greenhouse gas emissions to co-products, as distinct from wastes and residues, should also be reviewed in cases where electricity or heating and cooling are produced in co-generation or multi-generation plants. (114) If land with high stocks of carbon in its soil or in its vegetation is converted for the cultivation of raw materials for biofuels, bioliquids and biomass fuels, some of the stored carbon will generally be released into the atmosphere, leading to the formation of carbon dioxide (CO2). The resulting negative greenhouse gas impact can offset the positive greenhouse gas impact of the biofuels, bioliquids or biomass fuels, in some cases by a wide margin. The full carbon effects of such conversion should therefore be taken into account in calculating the greenhouse gas emissions savings of particular biofuels, bioliquids and biomass fuels. This is necessary to ensure that the greenhouse gas emissions saving calculation takes into account the totality of the carbon effects of the use of biofuels, bioliquids and biomass fuels. (115) In calculating the greenhouse gas impact of land conversion, economic operators should be able to use actual values for the carbon stocks associated with the reference land use and the land use after conversion. They should also be able to use standard values. The methodology of the Intergovernmental Panel on Climate Change (IPCC) is the appropriate basis for such standard values. That work is not currently expressed in a form that is immediately applicable by economic operators. The Commission should therefore revise its guidelines of 10 June 2010 for the calculation of land carbon stocks for the purposes of the rules for calculating the greenhouse gas impact of biofuels, bioliquids and their fossil fuel comparators, which are set out in an annex to this Directive, while ensuring consistency with Regulation (EU) No 525/2013 of the European Parliament and of the Council (16). (116) Co-products from the production and use of fuels should be taken into account in the calculation of greenhouse gas emissions. The substitution method is appropriate for the purposes of policy analysis, but not for the regulation of individual economic operators and individual consignments of transport fuels. In those cases, the energy allocation method is the most appropriate method, as it is easy to apply, is predictable over time, minimises counter-productive incentives and produces results that are generally comparable with those produced by the substitution method. For the purposes of policy analysis, the Commission should also, in its reporting, present results using the substitution method. (117) Co-products are different from residues and agricultural residues, as they are the primary aim of the production process. It is therefore appropriate to clarify that agricultural crop residues are residues and not co-products. This has no implications on the existing methodology but clarifies the existing provisions. (118) The established method of using energy allocation as a rule for dividing greenhouse gas emissions between co-products has worked well and should be continued. It is appropriate to align the methodology for calculating greenhouse gas emissions coming from the use of combined heat and power (CHP) when the CHP is used in processing biofuels, bioliquids and biomass fuels to the methodology applied to a CHP being the end-use. (119) The methodology takes into account the reduced greenhouse gas emissions arising from the use of CHP, compared to the use of electricity plants and heat-only plants, by taking into account the utility of heat compared to electricity, and the utility of heat at different temperatures. It follows that higher temperature should bear a larger part of the total greenhouse gas emissions than heat at low temperature, when the heat is co-produced with electricity. The methodology takes into account the whole pathway to final energy, including conversion to heat or electricity. (120) It is appropriate for the data used in the calculation of the default values to be obtained from independent, scientifically expert sources and to be updated as appropriate as those sources progress their work. The Commission should encourage those sources to address, when they update their work, emissions from cultivation, the effects of regional and climatological conditions, the effects of cultivation using sustainable agricultural and organic farming methods, and the scientific contributions of producers in the Union and in third countries, and civil society. (121) Global demand for agricultural commodities is growing. Part of that increase in demand is likely to be met through an increase in the amount of land devoted to agriculture. The restoration of land that has been severely degraded and therefore cannot otherwise be used for agricultural purposes is a way of increasing the amount of land available for cultivation. The sustainability scheme should promote the use of such restored land because the promotion of biofuels, bioliquids and biomass fuels will contribute to the growth in demand for agricultural commodities. (122) In order to ensure the harmonised implementation of the greenhouse gas emissions calculation methodology and to align to the latest scientific evidence, implementing powers should be conferred on the Commission to adapt the methodological principles and values necessary for assessing whether greenhouse gas emissions saving criteria have been fulfilled and to assess whether reports submitted by Member States and third countries contain accurate data on cultivation emissions of feedstock. (123) European gas grids are becoming more integrated. The promotion of the production and use of biomethane, its injection into a natural gas grid and cross-border trade create a need to ensure proper accounting of renewable energy as well as avoiding double incentives resulting from support schemes in different Member States. The mass balance system related to verification of bioenergy sustainability and the new Union database are intended to help address those issues. (124) The achievement of the objectives of this Directive requires that the Union and Member States dedicate a significant amount of financial resources to research and development in relation to renewable energy technologies. In particular, the European Institute of Innovation and Technology should give high priority to the research and development of renewable energy technologies. (125) The implementation of this Directive should, where relevant, reflect the Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters, in particular as implemented through Directive 2003/4/EC of the European Parliament and of the Council (17). (126) In order to amend or supplement non-essential elements of this Directive, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of establishing the methodology for calculating the quantity of renewable energy used for cooling and district cooling and amending the methodology for calculating energy from heat pumps; establishing the URDP and setting the conditions for finalising transactions of statistical transfer between Member States via the URDP; establishing appropriate minimum thresholds for greenhouse gas emissions savings of recycled carbon fuels; adopting, and if appropriate amending, the criteria for certification of low indirect land-use change-risk biofuels, bioliquids and biomass fuels and for determining the high indirect land-use change-risk feedstock for which significant expansion of the production into land with high-carbon stock is observed and the gradual decrease in their contribution to the targets laid down in this Directive; adapting the energy content of transport fuels to scientific and technical progress; establishing the Union methodology for setting the rules by which economic operators are to comply with the requirements for counting electricity as fully renewable when used for the production of renewable liquid and gaseous transport fuels of non-biological origin or when taken from the grid; specifying the methodology by which to determine the share of biofuel, and biogas for transport, resulting from biomass being processed with fossil fuels in a common process and the methodology by which to assess the greenhouse gas emissions savings from renewable liquid and gaseous transport fuels of non-biological origin and from recycled carbon fuels in order to ensure that credits from greenhouse gas emissions savings are given only once; amending by adding to, but not removing from, the lists of feedstock for the production of advanced biofuels and other biofuels and biogas; and supplementing or amending the rules for calculating the greenhouse gas impact of biofuels, bioliquids and their fossil fuel comparators. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (18). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (127) The measures necessary for the implementation of this Directive should be adopted in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (19). (128) Since the objective of this Directive, namely to achieve a share of at least 32 % of energy from renewable sources in the Union's gross final consumption of energy by 2030, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (129) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (20), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified. (130) The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive amendment as compared to Directive 2009/28/EC. The obligation to transpose provisions which are unchanged arises under that Directive. (131) This Directive should be without prejudice to the obligations of the Member States relating to the time-limit for the transposition into national law of Council Directive 2013/18/EU (21) and Directive (EU) 2015/1513, HAVE ADOPTED THIS DIRECTIVE: Article 1 Subject matter This Directive establishes a common framework for the promotion of energy from renewable sources. It sets a binding Union target for the overall share of energy from renewable sources in the Union's gross final consumption of energy in 2030. It also lays down rules on financial support for electricity from renewable sources, on self-consumption of such electricity, on the use of energy from renewable sources in the heating and cooling sector and in the transport sector, on regional cooperation between Member States, and between Member States and third countries, on guarantees of origin, on administrative procedures and on information and training. It also establishes sustainability and greenhouse gas emissions saving criteria for biofuels, bioliquids and biomass fuels. Article 2 Definitions For the purposes of this Directive, the relevant definitions in Directive 2009/72/EC of the European Parliament and of the Council (22) apply. The following definitions also apply: (1) ‘energy from renewable sources’ or ‘renewable energy’ means energy from renewable non-fossil sources, namely wind, solar (solar thermal and solar photovoltaic) and geothermal energy, ambient energy, tide, wave and other ocean energy, hydropower, biomass, landfill gas, sewage treatment plant gas, and biogas; (2) ‘ambient energy’ means naturally occurring thermal energy and energy accumulated in the environment with constrained boundaries, which can be stored in the ambient air, excluding in exhaust air, or in surface or sewage water; (3) ‘geothermal energy’ means energy stored in the form of heat beneath the surface of solid earth; (4) ‘gross final consumption of energy’ means the energy commodities delivered for energy purposes to industry, transport, households, services including public services, agriculture, forestry and fisheries, the consumption of electricity and heat by the energy branch for electricity, heat and transport fuel production, and losses of electricity and heat in distribution and transmission; (5) ‘support scheme’ means any instrument, scheme or mechanism applied by a Member State, or a group of Member States, that promotes the use of energy from renewable sources by reducing the cost of that energy, increasing the price at which it can be sold, or increasing, by means of a renewable energy obligation or otherwise, the volume of such energy purchased, including but not restricted to, investment aid, tax exemptions or reductions, tax refunds, renewable energy obligation support schemes including those using green certificates, and direct price support schemes including feed-in tariffs and sliding or fixed premium payments; (6) ‘renewable energy obligation’ means a support scheme requiring energy producers to include a given share of energy from renewable sources in their production, requiring energy suppliers to include a given share of energy from renewable sources in their supply, or requiring energy consumers to include a given share of energy from renewable sources in their consumption, including schemes under which such requirements may be fulfilled by using green certificates; (7) ‘financial instrument’ means a financial instrument as defined in point (29) of Article 2 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (23); (8) ‘SME’ means a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC (24); (9) ‘waste heat and cold’ means unavoidable heat or cold generated as by-product in industrial or power generation installations, or in the tertiary sector, which would be dissipated unused in air or water without access to a district heating or cooling system, where a cogeneration process has been used or will be used or where cogeneration is not feasible; (10) ‘repowering’ means renewing power plants that produce renewable energy, including the full or partial replacement of installations or operation systems and equipment for the purposes of replacing capacity or increasing the efficiency or capacity of the installation; (11) ‘distribution system operator’ means an operator as defined in point (6) of Article 2 of Directive 2009/72/EC and in point (6) of Article 2 of Directive 2009/73/EC of the European Parliament and of the Council (25); (12) ‘guarantee of origin’ means an electronic document which has the sole function of providing evidence to a final customer that a given share or quantity of energy was produced from renewable sources; (13) ‘residual energy mix’ means the total annual energy mix for a Member State, excluding the share covered by cancelled guarantees of origin; (14) ‘renewables self-consumer’ means a final customer operating within its premises located within confined boundaries or, where permitted by a Member State, within other premises, who generates renewable electricity for its own consumption, and who may store or sell self-generated renewable electricity, provided that, for a non-household renewables self-consumer, those activities do not constitute its primary commercial or professional activity; (15) ‘jointly acting renewables self-consumers’ means a group of at least two jointly acting renewables self-consumers in accordance with point (14) who are located in the same building or multi-apartment block; (16) ‘renewable energy community’ means a legal entity: (a) which, in accordance with the applicable national law, is based on open and voluntary participation, is autonomous, and is effectively controlled by shareholders or members that are located in the proximity of the renewable energy projects that are owned and developed by that legal entity; (b) the shareholders or members of which are natural persons, SMEs or local authorities, including municipalities; (c) the primary purpose of which is to provide environmental, economic or social community benefits for its shareholders or members or for the local areas where it operates, rather than financial profits; (17) ‘renewables power purchase agreement’ means a contract under which a natural or legal person agrees to purchase renewable electricity directly from an electricity producer; (18) ‘peer-to-peer trading’ of renewable energy means the sale of renewable energy between market participants by means of a contract with pre-determined conditions governing the automated execution and settlement of the transaction, either directly between market participants or indirectly through a certified third-party market participant, such as an aggregator. The right to conduct peer-to-peer trading shall be without prejudice to the rights and obligations of the parties involved as final customers, producers, suppliers or aggregators; (19) ‘district heating’ or ‘district cooling’ means the distribution of thermal energy in the form of steam, hot water or chilled liquids, from central or decentralised sources of production through a network to multiple buildings or sites, for the use of space or process heating or cooling; (20) ‘efficient district heating and cooling’ means efficient district heating and cooling as defined in point (41) of Article 2 of Directive 2012/27/EU; (21) ‘high-efficiency cogeneration’ means high-efficiency cogeneration as defined in point (34) of Article 2 of Directive 2012/27/EU; (22) ‘energy performance certificate’ means energy performance certificate as defined in point (12) of Article 2 of Directive 2010/31/EU; (23) ‘waste’ means waste as defined in point (1) of Article 3 of Directive 2008/98/EC, excluding substances that have been intentionally modified or contaminated in order to meet this definition; (24) ‘biomass’ means the biodegradable fraction of products, waste and residues from biological origin from agriculture, including vegetal and animal substances, from forestry and related industries, including fisheries and aquaculture, as well as the biodegradable fraction of waste, including industrial and municipal waste of biological origin; (25) ‘agricultural biomass’ means biomass produced from agriculture; (26) ‘forest biomass’ means biomass produced from forestry; (27) ‘biomass fuels’ means gaseous and solid fuels produced from biomass; (28) ‘biogas’ means gaseous fuels produced from biomass; (29) ‘biowaste’ means biowaste as defined in point (4) of Article 3 of Directive 2008/98/EC; (30) ‘sourcing area’ means the geographically defined area from which the forest biomass feedstock is sourced, from which reliable and independent information is available and where conditions are sufficiently homogeneous to evaluate the risk of the sustainability and legality characteristics of the forest biomass; (31) ‘forest regeneration’ means the re-establishment of a forest stand by natural or artificial means following the removal of the previous stand by felling or as a result of natural causes, including fire or storm; (32) ‘bioliquids’ means liquid fuel for energy purposes other than for transport, including electricity and heating and cooling, produced from biomass; (33) ‘biofuels’ means liquid fuel for transport produced from biomass; (34) ‘advanced biofuels’ means biofuels that are produced from the feedstock listed in Part A of Annex IX; (35) ‘recycled carbon fuels’ means liquid and gaseous fuels that are produced from liquid or solid waste streams of non-renewable origin which are not suitable for material recovery in accordance with Article 4 of Directive 2008/98/EC, or from waste processing gas and exhaust gas of non-renewable origin which are produced as an unavoidable and unintentional consequence of the production process in industrial installations; (36) ‘renewable liquid and gaseous transport fuels of non-biological origin’ means liquid or gaseous fuels which are used in the transport sector other than biofuels or biogas, the energy content of which is derived from renewable sources other than biomass; (37) ‘low indirect land-use change-risk biofuels, bioliquids and biomass fuels’ means biofuels, bioliquids and biomass fuels, the feedstock of which was produced within schemes which avoid displacement effects of food and feed-crop based biofuels, bioliquids and biomass fuels through improved agricultural practices as well as through the cultivation of crops on areas which were previously not used for cultivation of crops, and which were produced in accordance with the sustainability criteria for biofuels, bioliquids and biomass fuels laid down in Article 29; (38) ‘fuel supplier’ means an entity supplying fuel to the market that is responsible for passing fuel through an excise duty point or, in the case of electricity or where no excise is due or where duly justified, any other relevant entity designated by a Member State; (39) ‘starch-rich crops’ means crops comprising mainly cereals, regardless of whether the grains alone or the whole plant, such as in the case of green maize, are used; tubers and root crops, such as potatoes, Jerusalem artichokes, sweet potatoes, cassava and yams; and corm crops, such as taro and cocoyam; (40) ‘food and feed crops’ means starch-rich crops, sugar crops or oil crops produced on agricultural land as a main crop excluding residues, waste or ligno-cellulosic material and intermediate crops, such as catch crops and cover crops, provided that the use of such intermediate crops does not trigger demand for additional land; (41) ‘ligno-cellulosic material’ means material composed of lignin, cellulose and hemicellulose, such as biomass sourced from forests, woody energy crops and forest-based industries' residues and wastes; (42) ‘non-food cellulosic material’ means feedstock mainly composed of cellulose and hemicellulose, and having a lower lignin content than ligno-cellulosic material, including food and feed crop residues, such as straw, stover, husks and shells; grassy energy crops with a low starch content, such as ryegrass, switchgrass, miscanthus, giant cane; cover crops before and after main crops; ley crops; industrial residues, including from food and feed crops after vegetal oils, sugars, starches and protein have been extracted; and material from biowaste, where ley and cover crops are understood to be temporary, short-term sown pastures comprising grass-legume mixture with a low starch content to obtain fodder for livestock and improve soil fertility for obtaining higher yields of arable main crops; (43) ‘residue’ means a substance that is not the end product(s) that a production process directly seeks to produce; it is not a primary aim of the production process and the process has not been deliberately modified to produce it; (44) ‘agricultural, aquaculture, fisheries and forestry residues’ means residues that are directly generated by agriculture, aquaculture, fisheries and forestry and that do not include residues from related industries or processing; (45) ‘actual value’ means the greenhouse gas emissions savings for some or all of the steps of a specific biofuel, bioliquid or biomass fuel production process, calculated in accordance with the methodology laid down in Part C of Annex V or Part B of Annex VI; (46) ‘typical value’ means an estimate of the greenhouse gas emissions and greenhouse gas emissions savings for a particular biofuel, bioliquid or biomass fuel production pathway, which is representative of the Union consumption; (47) ‘default value’ means a value derived from a typical value by the application of pre-determined factors and that may, in circumstances specified in this Directive, be used in place of an actual value. Article 3 Binding overall Union target for 2030 1. Member States shall collectively ensure that the share of energy from renewable sources in the Union's gross final consumption of energy in 2030 is at least 32 %. The Commission shall assess that target with a view to submitting a legislative proposal by 2023 to increase it where there are further substantial costs reductions in the production of renewable energy, where needed to meet the Union's international commitments for decarbonisation, or where a significant decrease in energy consumption in the Union justifies such an increase. 2. Member States shall set national contributions to meet, collectively, the binding overall Union target set in paragraph 1 of this Article as part of their integrated national energy and climate plans in accordance with Articles 3 to 5 and 9 to 14 of Regulation (EU) 2018/1999. In preparing their draft integrated national energy and climate plans, Member States may consider the formula referred to in Annex II to that Regulation. If, on the basis of the assessment of the draft integrated national energy and climate plans submitted pursuant to Article 9 of Regulation (EU) 2018/1999, the Commission concludes that the national contributions of the Member States are insufficient for the collective achievement of the binding overall Union target, it shall follow the procedure laid down in Articles 9 and 31 of that Regulation. 3. Member States shall ensure that their national policies, including the obligations deriving from Articles 25 to 28 of this Directive, and their support schemes, are designed with due regard to the waste hierarchy as set out in Article 4 of Directive 2008/98/EC to aim to avoid undue distortive effects on the raw material markets. Member States shall grant no support for renewable energy produced from the incineration of waste if the separate collection obligations laid down in that Directive have not been complied with. 4. From 1 January 2021, the share of energy from renewable sources in each Member State's gross final consumption of energy shall not be lower than the baseline share shown in the third column of the table in Part A of Annex I to this Directive. Member States shall take the necessary measures to ensure compliance with that baseline share. If a Member State does not maintain its baseline share as measured over any one-year period, the first and second subparagraphs of Article 32(4) of Regulation (EU) 2018/1999 shall apply. 5. The Commission shall support the high ambition of Member States through an enabling framework comprising the enhanced use of Union funds, including additional funds to facilitate a just transition of carbon intensive regions towards increased shares of renewable energy, in particular financial instruments, especially for the following purposes: (a) reducing the cost of capital for renewable energy projects; (b) developing projects and programmes for integrating renewable sources into the energy system, for increasing flexibility of the energy system, for maintaining grid stability and for managing grid congestions; (c) developing transmission and distribution grid infrastructure, intelligent networks, storage facilities and interconnections, with the objective of arriving at a 15 % electricity interconnection target by 2030, in order to increase the technically feasible and economically affordable level of renewable energy in the electricity system; (d) enhancing regional cooperation between Member States and between Member States and third countries, through joint projects, joint support schemes and the opening of support schemes for renewable electricity to producers located in other Member States. 6. The Commission shall establish a facilitative platform in order to support Member States that use cooperation mechanisms to contribute to the binding overall Union target set in paragraph 1. Article 4 Support schemes for energy from renewable sources 1. In order to reach or exceed the Union target set in Article 3(1), and each Member State's contribution to that target set at a national level for the deployment of renewable energy, Member States may apply support schemes. 2. Support schemes for electricity from renewable sources shall provide incentives for the integration of electricity from renewable sources in the electricity market in a market-based and market-responsive way, while avoiding unnecessary distortions of electricity markets as well as taking into account possible system integration costs and grid stability. 3. Support schemes for electricity from renewable sources shall be designed so as to maximise the integration of electricity from renewable sources in the electricity market and to ensure that renewable energy producers are responding to market price signals and maximise their market revenues. To that end, with regard to direct price support schemes, support shall be granted in the form of a market premium, which could be, inter alia, sliding or fixed. Member States may exempt small-scale installations and demonstration projects from this paragraph, without prejudice to the applicable Union law on the internal market for electricity. 4. Member States shall ensure that support for electricity from renewable sources is granted in an open, transparent, competitive, non-discriminatory and cost-effective manner. Member States may exempt small-scale installations and demonstration projects from tendering procedures. Member States may also consider establishing mechanisms to ensure the regional diversification in the deployment of renewable electricity, in particular to ensure cost-efficient system integration. 5. Member States may limit tendering procedures to specific technologies where opening support schemes to all producers of electricity from renewable sources would lead to a suboptimal result, in view of: (a) the long-term potential of a particular technology; (b) the need to achieve diversification; (c) grid integration costs; (d) network constraints and grid stability; (e) for biomass, the need to avoid distortions of raw materials markets. 6. Where support for electricity from renewable sources is granted by means of a tendering procedure, Member States shall, in order to ensure a high project realisation rate: (a) establish and publish non-discriminatory and transparent criteria to qualify for the tendering procedure and set clear dates and rules for delivery of the project; (b) publish information about previous tendering procedures, including project realisation rates. 7. In order to increase the generation of energy from renewable sources in the outermost regions and small islands, Member States may adapt financial support schemes for projects located in those regions in order to take into account the production costs associated with their specific conditions of isolation and external dependence. 8. By 31 December 2021 and every three years thereafter, the Commission shall report to the European Parliament and to the Council on the performance of support for electricity from renewable sources granted by means of tendering procedures in the Union, analysing in particular the ability of tendering procedures to: (a) achieve cost-reduction; (b) achieve technological improvement; (c) achieve high realisation rates; (d) provide non-discriminatory participation of small actors and, where applicable, local authorities; (e) limit environmental impact; (f) ensure local acceptability; (g) ensure security of supply and grid integration. 9. This Article shall apply without prejudice to Articles 107 and 108 TFEU. Article 5 Opening of support schemes for electricity from renewable sources 1. Member States shall have the right, in accordance with Articles 7 to 13 of this Directive, to decide to which extent they support electricity from renewable sources which is produced in another Member State. However, Member States may open participation in support schemes for electricity from renewable sources to producers located in other Member States, subject to the conditions laid down in this Article. When opening participation in support schemes for electricity from renewable sources, Member States may provide that support for an indicative share of the newly-supported capacity, or of the budget allocated thereto, in each year is open to producers located in other Member States. Such indicative shares may, in each year, amount to at least 5 % from 2023 to 2026 and at least 10 % from 2027 to 2030, or, where lower, to the level of interconnectivity of the Member State concerned in any given year. In order to acquire further implementation experience, Member States may organise one or more pilot schemes where support is open to producers located in other Member States. 2. Member States may require proof of physical import of electricity from renewable sources. To that end, Member States may limit participation in their support schemes to producers located in Member States with which there is a direct connection via interconnectors. However, Member States shall not change or otherwise affect cross-zonal schedules and capacity allocation due to producers participating in cross-border support schemes. Cross-border electricity transfers shall be determined only by the outcome of capacity allocation pursuant to Union law on the internal market in electricity. 3. If a Member State decides to open participation in support schemes to producers located in other Member States, the relevant Member States shall agree on the principles of such participation. Such agreements shall cover at least the principles of allocation of renewable electricity that is the subject of cross-border support. 4. The Commission shall, upon the request of the relevant Member States, assist them throughout the negotiation process with the setting up of cooperation arrangements by providing information and analysis, including quantitative and qualitative data on the direct and indirect costs and benefits of cooperation, as well as with guidance and technical expertise. The Commission may encourage or facilitate the exchange of best practices and may develop templates for cooperation agreements in order to facilitate the negotiation process. The Commission shall assess, by 2025, the costs and benefits of the deployment of electricity from renewable sources in the Union pursuant to this Article. 5. By 2023, the Commission shall carry out an evaluation of the implementation of this Article. That evaluation shall assess the need to introduce an obligation on Member States partially to open participation in their support schemes for electricity from renewable sources to producers located in other Member States with a view to a 5 % opening by 2025 and a 10 % opening by 2030. Article 6 Stability of financial support 1. Without prejudice to adaptations necessary to comply with Articles 107 and 108 TFEU, Member States shall ensure that the level of, and the conditions attached to, the support granted to renewable energy projects are not revised in a way that negatively affects the rights conferred thereunder and undermines the economic viability of projects that already benefit from support. 2. Member States may adjust the level of support in accordance with objective criteria, provided that such criteria are established in the original design of the support scheme. 3. Member States shall publish a long-term schedule anticipating the expected allocation of support, covering, as a reference, at least the following five years, or, in the case of budgetary planning constraints, the following three years, including the indicative timing, the frequency of tendering procedures where appropriate, the expected capacity and budget or maximum unitary support expected to be allocated, and the expected eligible technologies, if applicable. That schedule shall be updated on an annual basis or, where necessary, to reflect recent market developments or expected allocation of support. 4. Member States shall, at least every five years, assess the effectiveness of their support schemes for electricity from renewable sources and their major distributive effects on different consumer groups, and on investments. That assessment shall take into account the effect of possible changes to the support schemes. The indicative long-term planning governing the decisions of the support and design of new support shall take into account the results of that assessment. Member States shall include the assessment in the relevant updates of their integrated national energy and climate plans and progress reports in accordance with Regulation (EU) 2018/1999. Article 7 Calculation of the share of energy from renewable sources 1. The gross final consumption of energy from renewable sources in each Member State shall be calculated as the sum of: (a) gross final consumption of electricity from renewable sources; (b) gross final consumption of energy from renewable sources in the heating and cooling sector; and (c) final consumption of energy from renewable sources in the transport sector. With regard to point (a), (b), or (c) of the first subparagraph, gas, electricity and hydrogen from renewable sources shall be considered only once for the purposes of calculating the share of gross final consumption of energy from renewable sources. Subject to the second subparagraph of Article 29(1), biofuels, bioliquids and biomass fuels that do not fulfil the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10) shall not be taken into account. 2. For the purposes of point (a) of the first subparagraph of paragraph 1, gross final consumption of electricity from renewable sources shall be calculated as the quantity of electricity produced in a Member State from renewable sources, including the production of electricity from renewables self-consumers and renewable energy communities and excluding the production of electricity in pumped storage units from water that has previously been pumped uphill. In multi-fuel plants using renewable and non-renewable sources, only the part of electricity produced from renewable sources shall be taken into account. For the purposes of that calculation, the contribution of each energy source shall be calculated on the basis of its energy content. The electricity generated by hydropower and wind power shall be accounted for in accordance with the normalisation rules set out in Annex II. 3. For the purposes of point (b) of the first subparagraph of paragraph 1, gross final consumption of energy from renewable sources in the heating and cooling sector shall be calculated as the quantity of district heating and cooling produced in a Member State from renewable sources, plus the consumption of other energy from renewable sources in industry, households, services, agriculture, forestry and fisheries, for heating, cooling and processing purposes. In multi-fuel plants using renewable and non-renewable sources, only the part of heating and cooling produced from renewable sources shall be taken into account. For the purposes of that calculation, the contribution of each energy source shall be calculated on the basis of its energy content. Ambient and geothermal energy used for heating and cooling by means of heat pumps and district cooling systems shall be taken into account for the purposes of point (b) of the first subparagraph of paragraph 1, provided that the final energy output significantly exceeds the primary energy input required to drive the heat pumps. The quantity of heat or cold to be considered to be energy from renewable sources for the purposes of this Directive shall be calculated in accordance with the methodology set out in Annex VII and shall take into account energy use in all end-use sectors. Thermal energy generated by passive energy systems, under which lower energy consumption is achieved passively through building design or from heat generated by energy from non-renewable sources, shall not be taken into account for the purposes of point (b) of the first subparagraph of paragraph 1. By 31 December 2021, the Commission shall adopt delegated acts in accordance with Article 35 to supplement this Directive by establishing a methodology for calculating the quantity of renewable energy used for cooling and district cooling and to amend Annex VII. That methodology shall include minimum seasonal performance factors for heat pumps operating in reverse mode. 4. For the purposes of point (c) of the first subparagraph of paragraph 1, the following requirements shall apply: (a) Final consumption of energy from renewable sources in the transport sector shall be calculated as the sum of all biofuels, biomass fuels and renewable liquid and gaseous transport fuels of non-biological origin consumed in the transport sector. However, renewable liquid and gaseous transport fuels of non-biological origin that are produced from renewable electricity shall be considered to be part of the calculation pursuant to point (a) of the first subparagraph of paragraph 1 only when calculating the quantity of electricity produced in a Member State from renewable sources. (b) For the calculation of final consumption of energy in the transport sector, the values regarding the energy content of transport fuels, as set out in Annex III, shall be used. For the determination of the energy content of transport fuels not included in Annex III, Member States shall use the relevant European Standards Organisation (ESO) standards in order to determine the calorific values of fuels. Where no ESO standard has been adopted for that purpose, Member States shall use the relevant International Organization for Standardisation (ISO) standards. 5. The share of energy from renewable sources shall be calculated as the gross final consumption of energy from renewable sources divided by the gross final consumption of energy from all energy sources, expressed as a percentage. For the purposes of the first subparagraph of this paragraph, the sum referred to in the first subparagraph of paragraph 1 of this Article shall be adjusted in accordance with Articles 8, 10, 12 and 13. In calculating a Member State's gross final consumption of energy for the purposes of measuring its compliance with the targets and indicative trajectory laid down in this Directive, the amount of energy consumed in aviation shall, as a proportion of that Member State's gross final consumption of energy, be considered to be no more than 6,18 %. For Cyprus and Malta the amount of energy consumed in aviation shall, as a proportion of those Member States' gross final consumption of energy, be considered to be no more than 4,12 %. 6. The methodology and definitions used in the calculation of the share of energy from renewable sources shall be those provided for in Regulation (EC) No 1099/2008. Member States shall ensure coherence of the statistical information used in calculating those sectoral and overall shares and of the statistical information reported to the Commission pursuant to that Regulation. Article 8 Union renewable development platform and statistical transfers between Member States 1. Member States may agree on the statistical transfer of a specified amount of energy from renewable sources from one Member State to another Member State. The transferred quantity shall be: (a) deducted from the amount of energy from renewable sources that is taken into account in calculating the renewable energy share of the Member State making the transfer for the purposes of this Directive; and (b) added to the amount of energy from renewable sources that is taken into account in calculating the renewable energy share of the Member State accepting the transfer for the purposes of this Directive. 2. In order to facilitate the achievement of the Union target set in Article 3(1) of this Directive and of each Member State's contribution to that target in accordance with Article 3(2) of this Directive, and to facilitate statistical transfers in accordance with paragraph 1 of this Article, the Commission shall establish a Union renewable development platform (‘URDP’). Member States may, on a voluntary basis, submit to the URDP annual data on their national contributions to the Union target or any benchmark set for monitoring progress in Regulation (EU) 2018/1999, including the amount by which they expect to fall short of or exceed their contribution, and an indication of the price at which they would accept to transfer any excess production of energy from renewable sources from or to another Member State. The price of those transfers shall be set on a case-by-case basis based on the URDP demand-and-supply matching mechanism. 3. The Commission shall ensure that the URDP is able to match the demand for and supply of the amounts of energy from renewable sources that are taken into account in the calculation of the renewable energy share of a Member State based on prices or other criteria specified by the Member State accepting the transfer. The Commission is empowered to adopt delegated acts in accordance with Article 35 to supplement this Directive by establishing the URDP and setting the conditions for the finalisation of transfers as referred to in paragraph 5 of this Article. 4. The arrangements referred to in paragraphs 1 and 2 may have a duration of one or more calendar years. Such arrangements shall be notified to the Commission or finalised on the URDP not later than 12 months after the end of each year in which they have effect. The information sent to the Commission shall include the quantity and price of the energy involved. For transfers finalised on the URDP, the parties involved and the information on the particular transfer shall be disclosed to the public. 5. Transfers shall become effective after all Member States involved in the transfer have notified the transfer to the Commission or after all clearing conditions are met on the URDP, as applicable. Article 9 Joint projects between Member States 1. Two or more Member States may cooperate on all types of joint projects with regard to the production of electricity, heating or cooling from renewable sources. Such cooperation may involve private operators. 2. Member States shall notify the Commission of the proportion or amount of electricity, heating or cooling from renewable sources produced by any joint project in their territory that became operational after 25 June 2009, or by the increased capacity of an installation that was refurbished after that date, which is to be regarded as counting towards the renewable energy share of another Member State for the purposes of this Directive. 3. The notification referred to in paragraph 2 shall: (a) describe the proposed installation or identify the refurbished installation; (b) specify the proportion or amount of electricity or heating or cooling produced from the installation which is to be regarded as counting towards the renewable energy share of the other Member State; (c) identify the Member State in whose favour the notification is being made; and (d) specify the period, in whole calendar years, during which the electricity or heating or cooling produced by the installation from renewable sources is to be regarded as counting towards the renewable energy share of the other Member State. 4. The duration of a joint project as referred to in this Article may extend beyond 2030. 5. A notification made under this Article shall not be varied or withdrawn without the joint agreement of the Member State making the notification and the Member State identified in accordance with point (c) of paragraph 3. 6. The Commission shall, upon the request of the Member States concerned, facilitate the establishment of joint projects between Member States, in particular via dedicated technical assistance and project development assistance. Article 10 Effects of joint projects between Member States 1. Within three months of the end of each year falling within the period referred to in point (d) of Article 9(3), the Member State that made the notification under Article 9 shall issue a letter of notification stating: (a) the total amount of electricity or heating or cooling produced from renewable sources during that year by the installation which was the subject of the notification under Article 9; and (b) the amount of electricity or heating or cooling produced from renewable sources during that year by that installation which is to count towards the renewable energy share of another Member State in accordance with the terms of the notification. 2. The notifying Member State shall submit the letter of notification to the Member State in whose favour the notification was made and to the Commission. 3. For the purposes of this Directive, the amount of electricity or heating or cooling from renewable sources notified in accordance with point (b) of paragraph 1 shall be: (a) deducted from the amount of electricity or heating or cooling from renewable sources that is taken into account in calculating the renewable energy share of the Member State issuing the letter of notification pursuant to paragraph 1; and (b) added to the amount of electricity or heating or cooling from renewable sources that is taken into account in calculating the renewable energy share of the Member State receiving the letter of notification pursuant to paragraph 2. Article 11 Joint projects between Member States and third countries 1. One or more Member States may cooperate with one or more third countries on all types of joint projects with regard to the production of electricity from renewable sources. Such cooperation may involve private operators and shall take place in full respect of international law. 2. Electricity from renewable sources produced in a third country shall be taken into account for the purposes of calculating the renewable energy shares of the Member States only where the following conditions are met: (a) the electricity is consumed in the Union, which is deemed to be met where: (i) an equivalent amount of electricity to the electricity accounted for has been firmly nominated to the allocated interconnection capacity by all responsible transmission system operators in the country of origin, the country of destination and, if relevant, each third country of transit; (ii) an equivalent amount of electricity to the electricity accounted for has been firmly registered in the schedule of balance by the responsible transmission system operator on the Union side of an interconnector; and (iii) the nominated capacity and the production of electricity from renewable sources by the installation referred to in point (b) refer to the same period of time; (b) the electricity is produced by an installation that became operational after 25 June 2009 or by the increased capacity of an installation that was refurbished after that date, under a joint project as referred to in paragraph 1; (c) the amount of electricity produced and exported has not received support from a support scheme of a third country other than investment aid granted to the installation; and (d) the electricity has been produced in accordance with international law, in a third country that is a signatory to the Council of Europe Convention for the Protection of Human Rights and Fundamental Freedoms, or other international conventions or treaties on human rights. 3. For the purposes of paragraph 4, Member States may apply to the Commission for account to be taken of electricity from renewable sources produced and consumed in a third country, in the context of the construction of an interconnector with a very long lead-time between a Member State and a third country where the following conditions are met: (a) construction of the interconnector started by 31 December 2026; (b) it is not possible for the interconnector to become operational by 31 December 2030; (c) it is possible for the interconnector to become operational by 31 December 2032; (d) after it becomes operational, the interconnector will be used for the export to the Union, in accordance with paragraph 2, of electricity from renewable sources; (e) the application relates to a joint project that fulfils the criteria set out in points (b) and (c) of paragraph 2 and that will use the interconnector after it becomes operational, and to a quantity of electricity that is no greater than the quantity that will be exported to the Union after the interconnector becomes operational. 4. The proportion or amount of electricity produced by any installation in the territory of a third country, which is to be regarded as counting towards the renewable energy share of one or more Member States for the purposes of this Directive, shall be notified to the Commission. When more than one Member State is concerned, the distribution between Member States of that proportion or amount shall be notified to the Commission. The proportion or amount shall not exceed the proportion or amount actually exported to, and consumed in, the Union, shall correspond to the amount referred to in point (a)(i) and (ii) of paragraph 2 and shall meet the conditions set out in point (a) of that paragraph. The notification shall be made by each Member State towards whose overall national target the proportion or amount of electricity is to count. 5. The notification referred to in paragraph 4 shall: (a) describe the proposed installation or identify the refurbished installation; (b) specify the proportion or amount of electricity produced from the installation which is to be regarded as counting towards the renewable energy share of a Member State as well as, subject to confidentiality requirements, the corresponding financial arrangements; (c) specify the period, in whole calendar years, during which the electricity is to be regarded as counting towards the renewable energy share of the Member State; and (d) include a written acknowledgement of points (b) and (c) by the third country in whose territory the installation is to become operational and an indication of the proportion or amount of electricity produced by the installation which will be used domestically by that third country. 6. The duration of a joint project as referred to in this Article may extend beyond 2030. 7. A notification made under this Article shall be varied or withdrawn only where there is a joint agreement between the Member State making the notification and the third country that has acknowledged the joint project in accordance with point (d) of paragraph 5. 8. Member States and the Union shall encourage the relevant bodies of the Energy Community to take, in conformity with the Energy Community Treaty, the measures necessary to allow the Contracting Parties to apply the provisions on cooperation between Member States laid down in this Directive. Article 12 Effects of joint projects between Member States and third countries 1. Within 12 months of the end of each year falling within the period specified under point (c) of Article 11(5), the notifying Member State shall issue a letter of notification stating: (a) the total amount of electricity produced from renewable sources during that year by the installation which was the subject of the notification under Article 11; (b) the amount of electricity produced from renewable sources during that year by that installation which is to count towards its renewable energy share in accordance with the terms of the notification under Article 11; and (c) evidence of compliance with the conditions laid down in Article 11(2). 2. The Member State referred to in paragraph 1 shall submit the letter of notification to the Commission and to the third country that has acknowledged the project in accordance with point (d) of Article 11(5). 3. For the purposes of calculating the renewable energy shares under this Directive, the amount of electricity from renewable sources notified in accordance with point (b) of paragraph 1 shall be added to the amount of energy from renewable sources that is taken into account in calculating the renewable energy shares of the Member State issuing the letter of notification. Article 13 Joint support schemes 1. Without prejudice to the obligations of Member States under Article 5, two or more Member States may decide, on a voluntary basis, to join or partly coordinate their national support schemes. In such cases, a certain amount of energy from renewable sources produced in the territory of one participating Member State may count towards the renewable energy share of another participating Member State, provided that the Member States concerned: (a) make a statistical transfer of specified amounts of energy from renewable sources from one Member State to another Member State in accordance with Article 8; or (b) set up a distribution rule agreed by participating Member States that allocates amounts of energy from renewable sources between the participating Member States. A distribution rule as referred to in point (b) of the first subparagraph shall be notified to the Commission not later than three months after the end of the first year in which it takes effect. 2. Within three months of the end of each year, each Member State that has made a notification under the second subparagraph of paragraph 1 shall issue a letter of notification stating the total amount of electricity or heating or cooling from renewable sources produced during the year which is to be the subject of the distribution rule. 3. For the purposes of calculating the renewable energy shares under this Directive, the amount of electricity or heating or cooling from renewable sources notified in accordance with paragraph 2 shall be reallocated between the Member States concerned in accordance with the notified distribution rule. 4. The Commission shall disseminate guidelines and best practices, and, upon the request of the Member States concerned, facilitate the establishment of joint support schemes between Member States. Article 14 Capacity increases For the purposes of Article 9(2) and point (b) of Article 11(2), units of energy from renewable sources imputable to an increase in the capacity of an installation shall be treated as if they were produced by a separate installation becoming operational at the moment at which the increase of capacity occurred. Article 15 Administrative procedures, regulations and codes 1. Member States shall ensure that any national rules concerning the authorisation, certification and licensing procedures that are applied to plants and associated transmission and distribution networks for the production of electricity, heating or cooling from renewable sources, to the process of transformation of biomass into biofuels, bioliquids, biomass fuels or other energy products, and to renewable liquid and gaseous transport fuels of non-biological origin are proportionate and necessary and contribute to the implementation of the energy efficiency first principle. Member States shall, in particular, take the appropriate steps to ensure that: (a) administrative procedures are streamlined and expedited at the appropriate administrative level and predictable timeframes are established for the procedures referred to in the first subparagraph; (b) rules concerning authorisation, certification and licensing are objective, transparent and proportionate, do not discriminate between applicants and take fully into account the particularities of individual renewable energy technologies; (c) administrative charges paid by consumers, planners, architects, builders and equipment and system installers and suppliers are transparent and cost-related; and (d) simplified and less burdensome authorisation procedures, including a simple-notification procedure, are established for decentralised devices, and for producing and storing energy from renewable sources. 2. Member States shall clearly define any technical specifications which are to be met by renewable energy equipment and systems in order to benefit from support schemes. Where European standards exist, including eco-labels, energy labels and other technical reference systems established by the European standardisation bodies, such technical specifications shall be expressed in terms of those standards. Such technical specifications shall not prescribe where the equipment and systems are to be certified and shall not impede the proper functioning of the internal market. 3. Member States shall ensure that their competent authorities at national, regional and local level include provisions for the integration and deployment of renewable energy, including for renewables self-consumption and renewable energy communities, and the use of unavoidable waste heat and cold when planning, including early spatial planning, designing, building and renovating urban infrastructure, industrial, commercial or residential areas and energy infrastructure, including electricity, district heating and cooling, natural gas and alternative fuel networks. Member States shall, in particular, encourage local and regional administrative bodies to include heating and cooling from renewable sources in the planning of city infrastructure where appropriate, and to consult the network operators to reflect the impact of energy efficiency and demand response programs as well as specific provisions on renewables self-consumption and renewable energy communities, on the infrastructure development plans of the operators. 4. Member States shall introduce appropriate measures in their building regulations and codes in order to increase the share of all kinds of energy from renewable sources in the building sector. In establishing such measures or in their support schemes, Member States may take into account, where applicable, national measures relating to substantial increases in renewables self-consumption, in local energy storage and in energy efficiency, relating to cogeneration and relating to passive, low-energy or zero-energy buildings. Member States shall, in their building regulations and codes or by other means with equivalent effect, require the use of minimum levels of energy from renewable sources in new buildings and in existing buildings that are subject to major renovation in so far as technically, functionally and economically feasible, and reflecting the results of the cost-optimal calculation carried out pursuant to Article 5(2) of Directive 2010/31/EU, and in so far as this does not negatively affect indoor air quality. Member States shall permit those minimum levels to be fulfilled, inter alia, through efficient district heating and cooling using a significant share of renewable energy and waste heat and cold. The requirements laid down in the first subparagraph shall apply to the armed forces only to the extent that its application does not cause any conflict with the nature and primary aim of the activities of the armed forces and with the exception of material used exclusively for military purposes. 5. Member States shall ensure that new public buildings, and existing public buildings that are subject to major renovation, at national, regional and local level, fulfil an exemplary role in the context of this Directive from 1 January 2012. Member States may, inter alia, allow that obligation to be fulfilled by complying with nearly zero-energy building provisions as required in Directive 2010/31/EU, or by providing for the roofs of public or mixed private-public buildings to be used by third parties for installations that produce energy from renewable sources. 6. With respect to their building regulations and codes, Member States shall promote the use of renewable heating and cooling systems and equipment that achieve a significant reduction of energy consumption. To that end, Member States shall use energy or eco-labels or other appropriate certificates or standards developed at national or Union level, where these exist, and ensure the provision of adequate information and advice on renewable, highly energy efficient alternatives as well as eventual financial instruments and incentives available in the case of replacement, with a view to promoting an increased replacement rate of old heating systems and an increased switch to solutions based on renewable energy in accordance with Directive 2010/31/EU. 7. Member States shall carry out an assessment of their potential of energy from renewable sources and of the use of waste heat and cold in the heating and cooling sector. That assessment shall, where appropriate, include spatial analysis of areas suitable for low-ecological-risk deployment and the potential for small-scale household projects and shall be included in the second comprehensive assessment required pursuant to Article 14(1) of Directive 2012/27/EU for the first time by 31 December 2020 and in the subsequent updates of the comprehensive assessments. 8. Member States shall assess the regulatory and administrative barriers to long-term renewables power purchase agreements, and shall remove unjustified barriers to, and facilitate the uptake of, such agreements. Member States shall ensure that those agreements are not subject to disproportionate or discriminatory procedures or charges. Member States shall describe policies and measures facilitating the uptake of renewables power purchase agreements in their integrated national energy and climate plans and progress reports pursuant to Regulation (EU) 2018/1999. Article 16 Organisation and duration of the permit-granting process 1. Member States shall set up or designate one or more contact points. Those contact points shall, upon request by the applicant, guide through and facilitate the entire administrative permit application and granting process. The applicant shall not be required to contact more than one contact point for the entire process. The permit-granting process shall cover the relevant administrative permits to build, repower and operate plants for the production of energy from renewable sources and assets necessary for their connection to the grid. The permit-granting process shall comprise all procedures from the acknowledgment of the receipt of the application to the transmission of the outcome of the procedure referred to in paragraph 2. 2. The contact point shall guide the applicant through the administrative permit application process in a transparent manner up to the delivery of one or several decisions by the responsible authorities at the end of the process, provide the applicant with all necessary information and involve, where appropriate, other administrative authorities. Applicants shall be allowed to submit relevant documents also in digital form. 3. The contact point shall make available a manual of procedures for developers of renewable energy production projects and shall provide that information also online, addressing distinctly also small-scale projects and renewables self-consumers projects. The online information shall indicate the contact point relevant to the applicant's application. If a Member State has more than one contact point, the online information shall indicate the contact point relevant to the applicant's application. 4. Without prejudice to paragraph 7, the permit-granting process referred to in paragraph 1 shall not exceed two years for power plants, including all relevant procedures of competent authorities. Where duly justified on the grounds of extraordinary circumstances, that two-year period may be extended by up to one year. 5. Without prejudice to paragraph 7, the permit-granting process shall not exceed one year for installations with an electrical capacity of less than 150 kW. Where duly justified on the grounds of extraordinary circumstances, that one-year period may be extended by up to one year. Member States shall ensure that applicants have easy access to simple procedures for the settlement of disputes concerning the permit-granting process and the issuance of permits to build and operate renewable energy plants, including, where applicable, alternative dispute resolution mechanisms. 6. Member States shall facilitate the repowering of existing renewable energy plants by ensuring a simplified and swift permit-granting process. The length of that process shall not exceed one year. Where duly justified on the grounds of extraordinary circumstances, such as on grounds of overriding safety reasons where the repowering project impacts substantially on the grid or the original capacity, size or performance of the installation, that one-year period may be extended by up to one year. 7. The deadlines established in this Article shall apply without prejudice to obligations under applicable Union environmental law, to judicial appeals, remedies and other proceedings before a court or tribunal, and to alternative dispute resolution mechanisms, including complaints procedures, non-judicial appeals and remedies, and may be extended for the duration of such procedures. 8. Member States may establish a simple-notification procedure for grid connections for repowering projects as referred to in Article 17(1). Where Member States do so, repowering shall be permitted following notification to the relevant authority where no significant negative environmental or social impact is expected. That authority shall decide within six months of receipt of a notification whether this is sufficient. Where the relevant authority decides that a notification is sufficient, it shall automatically grant the permit. Where that authority decides that the notification is not sufficient, it shall be necessary to apply for a new permit and the time-limits referred to in paragraph 6 shall apply. Article 17 Simple-notification procedure for grid connections 1. Member States shall establish a simple-notification procedure for grid connections whereby installations or aggregated production units of renewables self-consumers and demonstration projects, with an electrical capacity of 10,8 kW or less, or equivalent for connections other than three-phase connections, are to be connected to the grid following a notification to the distribution system operator. The distribution system operator may, within a limited period following the notification, reject the requested grid connection or propose an alternative grid connection point on justified grounds of safety concerns or technical incompatibility of the system components. In the case of a positive decision by the distribution system operator, or in the absence of a decision by the distribution system operator within one month following the notification, the installation or aggregated production unit may be connected. 2. Member States may allow a simple-notification procedure for installations or aggregated production units with an electrical capacity of above 10,8 kW and up to 50 kW, provided that grid stability, grid reliability and grid safety are maintained. Article 18 Information and training 1. Member States shall ensure that information on support measures is made available to all relevant actors, such as consumers including low-income, vulnerable consumers, renewables self-consumers, renewable energy communities, builders, installers, architects, suppliers of heating, cooling and electricity equipment and systems, and suppliers of vehicles compatible with the use of renewable energy and of intelligent transport systems. 2. Member States shall ensure that information on the net benefits, cost and energy efficiency of equipment and systems for the use of heating, cooling and electricity from renewable sources is made available either by the supplier of the equipment or system or by the competent authorities. 3. Member States shall ensure that certification schemes or equivalent qualification schemes are available for installers of small-scale biomass boilers and stoves, solar photovoltaic and solar thermal systems, shallow geothermal systems and heat pumps. Those schemes may take into account existing schemes and structures as appropriate, and shall be based on the criteria laid down in Annex IV. Each Member State shall recognise the certification awarded by other Member States in accordance with those criteria. 4. Member States shall make information on certification schemes or equivalent qualification schemes as referred to in paragraph 3 available to the public. Member States may also make the list of installers who are qualified or certified in accordance with paragraph 3 available to the public. 5. Member States shall ensure that guidance is made available to all relevant actors, in particular to planners and architects so that they are able properly to consider the optimal combination of energy from renewable sources, of high-efficiency technologies, and of district heating and cooling when planning, designing, building and renovating industrial, commercial or residential areas. 6. Member States, where appropriate with the participation of local and regional authorities, shall develop suitable information, awareness-raising, guidance or training programmes in order to inform citizens of how to exercise their rights as active customers, and of the benefits and practicalities, including technical and financial aspects, of developing and using energy from renewable sources, including by renewables self-consumption or in the framework of renewable energy communities. Article 19 Guarantees of origin for energy from renewable sources 1. For the purposes of demonstrating to final customers the share or quantity of energy from renewable sources in an energy supplier's energy mix and in the energy supplied to consumers under contracts marketed with reference to the consumption of energy from renewable sources, Member States shall ensure that the origin of energy from renewable sources can be guaranteed as such within the meaning of this Directive, in accordance with objective, transparent and non-discriminatory criteria. 2. To that end, Member States shall ensure that a guarantee of origin is issued in response to a request from a producer of energy from renewable sources, unless Member States decide, for the purposes of accounting for the market value of the guarantee of origin, not to issue such a guarantee of origin to a producer that receives financial support from a support scheme. Member States may arrange for guarantees of origin to be issued for energy from non-renewable sources. Issuance of guarantees of origin may be made subject to a minimum capacity limit. A guarantee of origin shall be of the standard size of 1 MWh. No more than one guarantee of origin shall be issued in respect of each unit of energy produced. Member States shall ensure that the same unit of energy from renewable sources is taken into account only once. Member States shall ensure that when a producer receives financial support from a support scheme, the market value of the guarantee of origin for the same production is taken into account appropriately in the relevant support scheme. It shall be presumed that the market value of the guarantee of origin has been taken into account appropriately in any of the following cases: (a) where the financial support is granted by way of a tendering procedure or a tradable green certificate system; (b) where the market value of the guarantees of origin is administratively taken into account in the level of financial support; or (c) where the guarantees of origin are not issued directly to the producer but to a supplier or consumer who buys the energy from renewable sources either in a competitive setting or in a long-term renewables power purchase agreement. In order to take into account the market value of the guarantee of origin, Member States may, inter alia, decide to issue a guarantee of origin to the producer and immediately cancel it. The guarantee of origin shall have no function in terms of a Member State's compliance with Article 3. Transfers of guarantees of origin, separately or together with the physical transfer of energy, shall have no effect on the decision of Member States to use statistical transfers, joint projects or joint support schemes for compliance with Article 3 or on the calculation of the gross final consumption of energy from renewable sources in accordance with Article 7. 3. For the purposes of paragraph 1, guarantees of origin shall be valid for 12 months after the production of the relevant energy unit. Member States shall ensure that all guarantees of origin that have not been cancelled expire at the latest 18 months after the production of the energy unit. Member States shall include expired guarantees of origin in the calculation of their residual energy mix. 4. For the purposes of disclosure referred to in paragraphs 8 and 13, Member States shall ensure that energy companies cancel guarantees of origin at the latest six months after the end of the validity of the guarantee of origin. 5. Member States or designated competent bodies shall supervise the issuance, transfer and cancellation of guarantees of origin. The designated competent bodies shall not have overlapping geographical responsibilities, and shall be independent of production, trade and supply activities. 6. Member States or the designated competent bodies shall put in place appropriate mechanisms to ensure that guarantees of origin are issued, transferred and cancelled electronically and are accurate, reliable and fraud-resistant. Member States and designated competent bodies shall ensure that the requirements they impose comply with the standard CEN - EN 16325. 7. A guarantee of origin shall specify at least: (a) the energy source from which the energy was produced and the start and end dates of production; (b) whether it relates to: (i) electricity; (ii) gas, including hydrogen; or (iii) heating or cooling; (c) the identity, location, type and capacity of the installation where the energy was produced; (d) whether the installation has benefited from investment support and whether the unit of energy has benefited in any other way from a national support scheme, and the type of support scheme; (e) the date on which the installation became operational; and (f) the date and country of issue and a unique identification number. Simplified information may be specified on guarantees of origin from installations of less than 50 kW. 8. Where an electricity supplier is required to demonstrate the share or quantity of energy from renewable sources in its energy mix for the purposes of point (a) of Article 3(9) of Directive 2009/72/EC, it shall do so by using guarantees of origin except: (a) as regards the share of its energy mix corresponding to non-tracked commercial offers, if any, for which the supplier may use the residual mix; or (b) where a Member State decides not to issue guarantees of origin to a producer that receives financial support from a support scheme. Where Member States have arranged to have guarantees of origin for other types of energy, suppliers shall use for disclosure the same type of guarantees of origin as the energy supplied. Likewise, guarantees of origin created pursuant to Article 14(10) of Directive 2012/27/EU may be used to substantiate any requirement to demonstrate the quantity of electricity produced from high-efficiency cogeneration. For the purposes of paragraph 2 of this Article, where electricity is generated from high-efficiency cogeneration using renewable sources, only one guarantee of origin specifying both characteristics may be issued. 9. Member States shall recognise guarantees of origin issued by other Member States in accordance with this Directive exclusively as evidence of the elements referred to in paragraph 1 and points (a) to (f) of the first subparagraph of paragraph 7. A Member State may refuse to recognise a guarantee of origin only where it has well-founded doubts about its accuracy, reliability or veracity. The Member State shall notify the Commission of such a refusal and its justification. 10. If the Commission finds that a refusal to recognise a guarantee of origin is unfounded, the Commission may adopt a decision requiring the Member State in question to recognise it. 11. Member States shall not recognise guarantees of origins issued by a third country except where the Union has concluded an agreement with that third country on mutual recognition of guarantees of origin issued in the Union and compatible guarantees of origin systems established in that third country, and only where there is direct import or export of energy. 12. A Member State may, in accordance with Union law, introduce objective, transparent and non-discriminatory criteria for the use of guarantees of origin in accordance with the obligations laid down in Article 3(9) of Directive 2009/72/EC. 13. The Commission shall adopt a report assessing options to establish a Union-wide green label with a view to promoting the use of renewable energy coming from new installations. Suppliers shall use the information contained in guarantees of origin to demonstrate compliance with the requirements of such a label. Article 20 Access to and operation of the grids 1. Where relevant, Member States shall assess the need to extend existing gas network infrastructure to facilitate the integration of gas from renewable sources. 2. Where relevant, Member States shall require transmission system operators and distribution system operators in their territory to publish technical rules in accordance with Article 8 of Directive 2009/73/EC, in particular regarding network connection rules that include gas quality, gas odoration and gas pressure requirements. Member States shall also require transmission and distribution system operators to publish the connection tariffs to connect gas from renewable sources based on objective, transparent and non-discriminatory criteria. 3. Subject to their assessment included in the integrated national energy and climate plans in accordance with Annex I to Regulation (EU) 2018/1999 on the necessity to build new infrastructure for district heating and cooling from renewable sources in order to achieve the Union target set in Article 3(1) of this Directive, Member States shall, where relevant, take the necessary steps with a view to developing a district heating and cooling infrastructure to accommodate the development of heating and cooling from large biomass, solar energy, ambient energy and geothermal energy facilities and from waste heat and cold. Article 21 Renewables self-consumers 1. Member States shall ensure that consumers are entitled to become renewables self-consumers, subject to this Article. 2. Member States shall ensure that renewables self-consumers, individually or through aggregators, are entitled: (a) to generate renewable energy, including for their own consumption, store and sell their excess production of renewable electricity, including through renewables power purchase agreements, electricity suppliers and peer-to-peer trading arrangements, without being subject: (i) in relation to the electricity that they consume from or feed into the grid, to discriminatory or disproportionate procedures and charges, and to network charges that are not cost-reflective; (ii) in relation to their self-generated electricity from renewable sources remaining within their premises, to discriminatory or disproportionate procedures, and to any charges or fees; (b) to install and operate electricity storage systems combined with installations generating renewable electricity for self-consumption without liability for any double charge, including network charges, for stored electricity remaining within their premises; (c) to maintain their rights and obligations as final consumers; (d) to receive remuneration, including, where applicable, through support schemes, for the self-generated renewable electricity that they feed into the grid, which reflects the market value of that electricity and which may take into account its long-term value to the grid, the environment and society. 3. Member States may apply non-discriminatory and proportionate charges and fees to renewables self-consumers, in relation to their self-generated renewable electricity remaining within their premises in one or more of the following cases: (a) if the self-generated renewable electricity is effectively supported via support schemes, only to the extent that the economic viability of the project and the incentive effect of such support are not undermined; (b) from 1 December 2026, if the overall share of self-consumption installations exceeds 8 % of the total installed electricity capacity of a Member State, and if it is demonstrated, by means of a cost-benefit analysis performed by the national regulatory authority of that Member State, which is conducted by way of an open, transparent and participatory process, that the provision laid down in point (a)(ii) of paragraph 2 either results in a significant disproportionate burden on the long-term financial sustainability of the electric system, or creates an incentive exceeding what is objectively needed to achieve cost-effective deployment of renewable energy, and that such burden or incentive cannot be minimised by taking other reasonable actions; or (c) if the self-generated renewable electricity is produced in installations with a total installed electrical capacity of more than 30 kW. 4. Member States shall ensure that renewables self-consumers located in the same building, including multi-apartment blocks, are entitled to engage jointly in activities referred to in paragraph 2 and that they are permitted to arrange sharing of renewable energy that is produced on their site or sites between themselves, without prejudice to the network charges and other relevant charges, fees, levies and taxes applicable to each renewables self-consumer. Member States may differentiate between individual renewables self-consumers and jointly acting renewables self-consumers. Any such differentiation shall be proportionate and duly justified. 5. The renewables self-consumer's installation may be owned by a third party or managed by a third party for installation, operation, including metering and maintenance, provided that the third party remains subject to the renewables self-consumer's instructions. The third party itself shall not be considered to be a renewables self-consumer. 6. Member States shall put in place an enabling framework to promote and facilitate the development of renewables self-consumption based on an assessment of the existing unjustified barriers to, and of the potential of, renewables self-consumption in their territories and energy networks. That enabling framework shall, inter alia: (a) address accessibility of renewables self-consumption to all final customers, including those in low-income or vulnerable households; (b) address unjustified barriers to the financing of projects in the market and measures to facilitate access to finance; (c) address other unjustified regulatory barriers to renewables self-consumption, including for tenants; (d) address incentives to building owners to create opportunities for renewables self-consumption, including for tenants; (e) grant renewables self-consumers, for self-generated renewable electricity that they feed into the grid, non-discriminatory access to relevant existing support schemes as well as to all electricity market segments; (f) ensure that renewables self-consumers contribute in an adequate and balanced way to the overall cost sharing of the system when electricity is fed into the grid. Member States shall include a summary of the policies and measures under the enabling framework and an assessment of their implementation respectively in their integrated national energy and climate plans and progress reports pursuant to Regulation (EU) 2018/1999. 7. This Article shall apply without prejudice to Articles 107 and 108 TFEU. Article 22 Renewable energy communities 1. Member States shall ensure that final customers, in particular household customers, are entitled to participate in a renewable energy community while maintaining their rights or obligations as final customers, and without being subject to unjustified or discriminatory conditions or procedures that would prevent their participation in a renewable energy community, provided that for private undertakings, their participation does not constitute their primary commercial or professional activity. 2. Member States shall ensure that renewable energy communities are entitled to: (a) produce, consume, store and sell renewable energy, including through renewables power purchase agreements; (b) share, within the renewable energy community, renewable energy that is produced by the production units owned by that renewable energy community, subject to the other requirements laid down in this Article and to maintaining the rights and obligations of the renewable energy community members as customers; (c) access all suitable energy markets both directly or through aggregation in a non-discriminatory manner. 3. Member States shall carry out an assessment of the existing barriers and potential of development of renewable energy communities in their territories. 4. Member States shall provide an enabling framework to promote and facilitate the development of renewable energy communities. That framework shall ensure, inter alia, that: (a) unjustified regulatory and administrative barriers to renewable energy communities are removed; (b) renewable energy communities that supply energy or provide aggregation or other commercial energy services are subject to the provisions relevant for such activities; (c) the relevant distribution system operator cooperates with renewable energy communities to facilitate energy transfers within renewable energy communities; (d) renewable energy communities are subject to fair, proportionate and transparent procedures, including registration and licensing procedures, and cost-reflective network charges, as well as relevant charges, levies and taxes, ensuring that they contribute, in an adequate, fair and balanced way, to the overall cost sharing of the system in line with a transparent cost-benefit analysis of distributed energy sources developed by the national competent authorities; (e) renewable energy communities are not subject to discriminatory treatment with regard to their activities, rights and obligations as final customers, producers, suppliers, distribution system operators, or as other market participants; (f) the participation in the renewable energy communities is accessible to all consumers, including those in low-income or vulnerable households; (g) tools to facilitate access to finance and information are available; (h) regulatory and capacity-building support is provided to public authorities in enabling and setting up renewable energy communities, and in helping authorities to participate directly; (i) rules to secure the equal and non-discriminatory treatment of consumers that participate in the renewable energy community are in place. 5. The main elements of the enabling framework referred to in paragraph 4, and of its implementation, shall be part of the updates of the Member States' integrated national energy and climate plans and progress reports pursuant to Regulation (EU) 2018/1999. 6. Member States may provide for renewable energy communities to be open to cross-border participation. 7. Without prejudice to Articles 107 and 108 TFEU, Member States shall take into account specificities of renewable energy communities when designing support schemes in order to allow them to compete for support on an equal footing with other market participants. Article 23 Mainstreaming renewable energy in heating and cooling 1. In order to promote the use of renewable energy in the heating and cooling sector, each Member State shall endeavour to increase the share of renewable energy in that sector by an indicative 1,3 percentage points as an annual average calculated for the periods 2021 to 2025 and 2026 to 2030, starting from the share of renewable energy in the heating and cooling sector in 2020, expressed in terms of national share of final energy consumption and calculated in accordance with the methodology set out in Article 7, without prejudice to paragraph 2 of this Article. That increase shall be limited to an indicative 1,1 percentage points for Member States where waste heat and cold is not used. Member States shall, where appropriate, prioritise the best available technologies. 2. For the purposes of paragraph 1, when calculating its share of renewable energy in the heating and cooling sector and its average annual increase in accordance with that paragraph, each Member State: (a) may count waste heat and cold, subject to a limit of 40 % of the average annual increase; (b) where its share of renewable energy in the heating and cooling sector is above 60 %, may count any such share as fulfilling the average annual increase; and (c) where its share of renewable energy in the heating and cooling sector is above 50 % and up to 60 %, may count any such share as fulfilling half of the average annual increase. When deciding which measures to adopt for the purposes of deploying energy from renewable sources in the heating and cooling sector, Member States may take into account cost-effectiveness reflecting structural barriers arising from the high share of natural gas or cooling, or from a dispersed settlement structure with low population density. Where those measures would result in a lower average annual increase than that referred to in paragraph 1 of this Article, Member States shall make it public, for instance by the means of their integrated national energy and climate progress reports pursuant to Article 20 of Regulation (EU) 2018/1999, and provide the Commission with reasons, including of choice of measures as referred to the second subparagraph of this paragraph. 3. On the basis of objective and non-discriminatory criteria, Member States may establish and make public a list of measures and may designate and make public the implementing entities, such as fuel suppliers, public or professional bodies, which are to contribute to the average annual increase referred to in paragraph 1. 4. Member States may implement the average annual increase referred to in paragraph 1 by means, inter alia, of one or more of the following options: (a) physical incorporation of renewable energy or waste heat and cold in the energy and energy fuel supplied for heating and cooling; (b) direct mitigation measures such as the installation of highly efficient renewable heating and cooling systems in buildings, or the use of renewable energy or waste heat and cold in industrial heating and cooling processes; (c) indirect mitigation measures covered by tradable certificates proving compliance with the obligation laid down in paragraph 1 through support to indirect mitigation measures, carried out by another economic operator such as an independent renewable technology installer or energy service company providing renewable installation services; (d) other policy measures, with an equivalent effect, to reach the average annual increase referred to in paragraph 1, including fiscal measures or other financial incentives. When adopting and implementing the measures referred to in the first subparagraph, Member States shall aim to ensure the accessibility of measures to all consumers, in particular those in low-income or vulnerable households, who would not otherwise possess sufficient up-front capital to benefit. 5. Member States may use the structures established under the national energy savings obligations set out in Article 7 of Directive 2012/27/EU to implement and monitor the measures referred to in paragraph 3 of this Article. 6. Where entities are designated under paragraph 3, Member States shall ensure that the contribution by those designated entities is measurable and verifiable and that the designated entities report annually on: (a) the total amount of energy supplied for heating and cooling; (b) the total amount of renewable energy supplied for heating and cooling; (c) the amount of waste heat and cold supplied for heating and cooling; (d) the share of renewable energy and waste heat and cold in the total amount of energy supplied for heating and cooling; and (e) the type of renewable energy source. Article 24 District heating and cooling 1. Member States shall ensure that information on the energy performance and the share of renewable energy in their district heating and cooling systems is provided to final consumers in an easily accessible manner, such as on the suppliers' websites, on annual bills or upon request. 2. Member States shall lay down the necessary measures and conditions to allow customers of district heating or cooling systems which are not efficient district heating and cooling systems, or which are not such a system by 31 December 2025 on the basis of a plan approved by the competent authority, to disconnect by terminating or modifying their contract in order to produce heating or cooling from renewable sources themselves. Where the termination of a contract is linked to physical disconnection, such a termination may be made conditional on compensation for the costs directly incurred as a result of the physical disconnection and for the undepreciated portion of assets needed to provide heat and cold to that customer. 3. Member States may restrict the right to disconnect by terminating or modifying a contract in accordance with paragraph 2 to customers who can demonstrate that the planned alternative supply solution for heating or cooling results in a significantly better energy performance. The energy-performance assessment of the alternative supply solution may be based on the energy performance certificate. 4. Member States shall lay down the necessary measures to ensure that district heating and cooling systems contribute to the increase referred to in Article 23(1) of this Directive by implementing at least one of the two following options: (a) Endeavour to increase the share of energy from renewable sources and from waste heat and cold in district heating and cooling by at least one percentage point as an annual average calculated for the period 2021 to 2025 and for the period 2026 to 2030, starting from the share of energy from renewable sources and from waste heat and cold in district heating and cooling in 2020, expressed in terms of share of final energy consumption in district heating and cooling, by implementing measures that can be expected to trigger that average annual increase in years with normal climatic conditions. Member States with a share of energy from renewable sources and from waste heat and cold in district heating and cooling above 60 % may count any such share as fulfilling the average annual increase referred to in the first subparagraph of this point. Member States shall lay down the necessary measures to implement the average annual increase referred to in the first subparagraph of this point in their integrated national energy and climate plans pursuant to Annex I to Regulation (EU) 2018/1999. (b) Ensure that operators of district heating or cooling systems are obliged to connect suppliers of energy from renewable sources and from waste heat and cold or are obliged to offer to connect and purchase heat or cold from renewable sources and from waste heat and cold from third-party suppliers based on non-discriminatory criteria set by the competent authority of the Member State concerned, where they need to do one or more of the following: (i) meet demand from new customers; (ii) replace existing heat or cold generation capacity; (iii) expand existing heat or cold generation capacity. 5. Where a Member State exercises the option referred to in point (b) of paragraph 4, an operator of a district heating or cooling system may refuse to connect and to purchase heat or cold from a third-party supplier where: (a) the system lacks the necessary capacity due to other supplies of waste heat and cold, of heat or cold from renewable sources or of heat or cold produced by high-efficiency cogeneration; (b) the heat or cold from the third-party supplier does not meet the technical parameters necessary to connect and ensure the reliable and safe operation of the district heating and cooling system; or (c) the operator can demonstrate that providing access would lead to an excessive heat or cold cost increase for final customers compared to the cost of using the main local heat or cold supply with which the renewable source or waste heat and cold would compete. Member States shall ensure that, when an operator of a district heating or cooling system refuses to connect a supplier of heating or cooling pursuant to the first subparagraph, information on the reasons for the refusal, as well as the conditions to be met and measures to be taken in the system in order to enable the connection, is provided by that operator to the competent authority in accordance with paragraph 9. 6. Where a Member State exercises the option referred to in point (b) of paragraph 4, it may exempt operators of the following district heating and cooling systems from the application of that point: (a) efficient district heating and cooling; (b) efficient district heating and cooling that exploits high-efficiency cogeneration; (c) district heating and cooling that, on the basis of a plan approved by the competent authority, is efficient district heating and cooling by 31 December 2025; (d) district heating and cooling with a total rated thermal input below 20 MW. 7. The right to disconnect by terminating or modifying a contract in accordance with paragraph 2 may be exercised by individual customers, by joint undertakings formed by customers or by parties acting on behalf of customers. For multi-apartment blocks, such disconnection may be exercised only at a whole building level in accordance with the applicable housing law. 8. Member States shall require electricity distribution system operators to assess at least every four years, in cooperation with the operators of district heating or cooling systems in their respective area, the potential for district heating or cooling systems to provide balancing and other system services, including demand response and storing of excess electricity from renewable sources, and whether the use of the identified potential would be more resource- and cost-efficient than alternative solutions. 9. Member States shall ensure that the rights of consumers and the rules for operating district heating and cooling systems in accordance with this Article are clearly defined and enforced by the competent authority. 10. A Member State shall not be required to apply paragraphs 2 to 9 of this Article where: (a) its share of district heating and cooling is less than or equal to 2 % of the overall consumption of energy in heating and cooling on 24 December 2018; (b) its share of district heating and cooling is increased above 2 % by developing new efficient district heating and cooling based on its integrated national energy and climate plan pursuant to Annex I to Regulation (EU) 2018/1999 or the assessment referred to in Article 15(7) of this Directive; or (c) its share of systems referred to in paragraph 6 of this Article constitutes over 90 % of total sales of its district heating and cooling. Article 25 Mainstreaming renewable energy in the transport sector 1. In order to mainstream the use of renewable energy in the transport sector, each Member State shall set an obligation on fuel suppliers to ensure that the share of renewable energy within the final consumption of energy in the transport sector is at least 14 % by 2030 (minimum share) in accordance with an indicative trajectory set by the Member State and calculated in accordance with the methodology set out in this Article and in Articles 26 and 27. The Commission shall assess that obligation, with a view to submitting, by 2023, a legislative proposal to increase it in the event of further substantial costs reductions in the production of renewable energy, where necessary to meet the Union's international commitments for decarbonisation, or where justified on the grounds of a significant decrease in energy consumption in the Union. Member States may exempt, or distinguish between, different fuel suppliers and different energy carriers when setting the obligation on the fuel suppliers, ensuring that the varying degrees of maturity and the cost of different technologies are taken into account. For the calculation of the minimum share referred to in the first subparagraph, Member States: (a) shall take into account renewable liquid and gaseous transport fuels of non-biological origin also when they are used as intermediate products for the production of conventional fuels; and (b) may take into account recycled carbon fuels. Within the minimum share referred to in the first subparagraph, the contribution of advanced biofuels and biogas produced from the feedstock listed in Part A of Annex IX as a share of final consumption of energy in the transport sector shall be at least 0,2 % in 2022, at least 1 % in 2025 and at least 3,5 % in 2030. Member States may exempt fuel suppliers supplying fuel in the form of electricity or renewable liquid and gaseous transport fuels of non-biological origin from the requirement to comply with the minimum share of advanced biofuels and biogas produced from the feedstock listed in Part A of Annex IX with respect to those fuels. When setting the obligation referred to in the first and fourth subparagraphs to ensure the achievement of the share set out therein, Member States may do so, inter alia, by means of measures targeting volumes, energy content or greenhouse gas emissions, provided that it is demonstrated that the minimum shares referred to in the first and fourth subparagraphs are achieved. 2. The greenhouse gas emissions savings from the use of renewable liquid and gaseous transport fuels of non-biological origin shall be at least 70 % from 1 January 2021. By 1 January 2021, the Commission shall adopt a delegated act in accordance with Article 35 to supplement this Directive by establishing appropriate minimum thresholds for greenhouse gas emissions savings of recycled carbon fuels through a life-cycle assessment that takes into account the specificities of each fuel. Article 26 Specific rules for biofuels, bioliquids and biomass fuels produced from food and feed crops 1. For the calculation of a Member State's gross final consumption of energy from renewable sources referred to in Article 7 and the minimum share referred to in the first subparagraph of Article 25(1), the share of biofuels and bioliquids, as well as of biomass fuels consumed in transport, where produced from food and feed crops, shall be no more than one percentage point higher than the share of such fuels in the final consumption of energy in the road and rail transport sectors in 2020 in that Member State, with a maximum of 7 % of final consumption of energy in the road and rail transport sectors in that Member State. Where that share is below 1 % in a Member State, it may be increased to a maximum of 2 % of the final consumption of energy in the road and rail transport sectors. Member States may set a lower limit and may distinguish, for the purposes of Article 29(1), between different biofuels, bioliquids and biomass fuels produced from food and feed crops, taking into account best available evidence on indirect land-use change impact. Member States may, for example, set a lower limit for the share of biofuels, bioliquids and biomass fuels produced from oil crops. Where the share of biofuels and bioliquids, as well as of biomass fuels consumed in transport, produced from food and feed crops in a Member State is limited to a share lower than 7 % or a Member State decides to limit the share further, that Member State may reduce the minimum share referred to in the first subparagraph of Article 25(1) accordingly, by a maximum of 7 percentage points. 2. For the calculation of a Member State's gross final consumption of energy from renewable sources referred to in Article 7 and the minimum share referred to in the first subparagraph of Article 25(1), the share of high indirect land-use change-risk biofuels, bioliquids or biomass fuels produced from food and feed crops for which a significant expansion of the production area into land with high-carbon stock is observed shall not exceed the level of consumption of such fuels in that Member State in 2019, unless they are certified to be low indirect land-use change-risk biofuels, bioliquids or biomass fuels pursuant to this paragraph. From 31 December 2023 until 31 December 2030 at the latest, that limit shall gradually decrease to 0 %. By 1 February 2019, the Commission shall submit to the European Parliament and to the Council a report on the status of worldwide production expansion of the relevant food and feed crops. By 1 February 2019, the Commission shall adopt a delegated act in accordance with Article 35 to supplement this Directive by setting out the criteria for certification of low indirect land-use change-risk biofuels, bioliquids and biomass fuels and for determining the high indirect land-use change-risk feedstock for which a significant expansion of the production area into land with high-carbon stock is observed. The report and the accompanying delegated act shall be based on the best available scientific data. By 1 September 2023, the Commission shall review the criteria laid down in the delegated act referred to in the fourth subparagraph based on the best available scientific data and shall adopt delegated acts in accordance with Article 35 to amend such criteria, where appropriate, and to include a trajectory to gradually decrease the contribution to the Union target set in Article 3(1) and to the minimum share referred to in the first subparagraph of Article 25(1), of high indirect land-use change-risk biofuels, bioliquids and biomass fuels produced from feedstock for which a significant expansion of the production into land with high-carbon stock is observed. Article 27 Calculation rules with regard to the minimum shares of renewable energy in the transport sector 1. For the calculation of the minimum shares referred to in the first and fourth subparagraphs of Article 25(1), the following provisions shall apply: (a) for the calculation of the denominator, that is the energy content of road- and rail- transport fuels supplied for consumption or use on the market, petrol, diesel, natural gas, biofuels, biogas, renewable liquid and gaseous transport fuels of non-biological origin, recycled carbon fuels and electricity supplied to the road and rail transport sectors, shall be taken into account; (b) for the calculation of the numerator, that is the amount of energy from renewable sources consumed in the transport sector for the purposes of the first subparagraph of Article 25(1), the energy content of all types of energy from renewable sources supplied to all transport sectors, including renewable electricity supplied to the road and rail transport sectors, shall be taken into account. Member States may also take into account recycled carbon fuels. For the calculation of the numerator, the share of biofuels and biogas produced from the feedstock listed in Part B of Annex IX shall, except for in Cyprus and Malta, be limited to 1,7 % of the energy content of transport fuels supplied for consumption or use on the market. Member States may, where justified, modify that limit, taking into account the availability of feedstock. Any such modification shall be subject to approval by the Commission; (c) for the calculation of both numerator and denominator, the values regarding the energy content of transport fuels set out in Annex III shall be used. For the determination of the energy content of transport fuels not included in Annex III, the Member States shall use the relevant ESO standards for the determination of the calorific values of fuels. Where no ESO standard has been adopted for that purpose, the relevant ISO standards shall be used. The Commission is empowered to adopt delegated acts in accordance with Article 35 to amend this Directive by adapting the energy content of transport fuels, as set out in Annex III, in accordance with scientific and technical progress. 2. For the purposes of demonstrating compliance with the minimum shares referred to in Article 25(1): (a) the share of biofuels and biogas for transport produced from the feedstock listed in Annex IX may be considered to be twice its energy content; (b) the share of renewable electricity shall be considered to be four times its energy content when supplied to road vehicles and may be considered to be 1,5 times its energy content when supplied to rail transport; (c) with the exception of fuels produced from food and feed crops, the share of fuels supplied in the aviation and maritime sectors shall be considered to be 1,2 times their energy content. 3. For the calculation of the share of renewable electricity in the electricity supplied to road and rail vehicles for the purposes of paragraph 1 of this Article, Member States shall refer to the two-year period before the year in which the electricity is supplied in their territory. By way of derogation from the first subparagraph of this paragraph, to determine the share of electricity for the purposes of paragraph 1 of this Article, in the case of electricity obtained from a direct connection to an installation generating renewable electricity and supplied to road vehicles, that electricity shall be fully counted as renewable. In order to ensure that the expected increase in demand for electricity in the transport sector beyond the current baseline is met with additional renewable energy generation capacity, the Commission shall develop a framework on additionality in the transport sector and shall develop different options with a view to determining the baseline of Member States and measuring additionality. For the purposes of this paragraph, where electricity is used for the production of renewable liquid and gaseous transport fuels of non-biological origin, either directly or for the production of intermediate products, the average share of electricity from renewable sources in the country of production, as measured two years before the year in question, shall be used to determine the share of renewable energy. However, electricity obtained from direct connection to an installation generating renewable electricity may be fully counted as renewable electricity where it is used for the production of renewable liquid and gaseous transport fuels of non-biological origin, provided that the installation: (a) comes into operation after, or at the same time as, the installation producing the renewable liquid and gaseous transport fuels of non-biological origin; and (b) is not connected to the grid or is connected to the grid but evidence can be provided that the electricity concerned has been supplied without taking electricity from the grid. Electricity that has been taken from the grid may be counted as fully renewable provided that it is produced exclusively from renewable sources and the renewable properties and other appropriate criteria have been demonstrated, ensuring that the renewable properties of that electricity are claimed only once and only in one end-use sector. By 31 December 2021, the Commission shall adopt a delegated act in accordance with Article 35 to supplement this Directive by establishing a Union methodology setting out detailed rules by which economic operators are to comply with the requirements laid down in the fifth and sixth subparagraphs of this paragraph. Article 28 Other provisions on renewable energy in the transport sector 1. With a view to minimising the risk of single consignments being claimed more than once in the Union, Member States and the Commission shall strengthen cooperation among national systems and between national systems and voluntary schemes and verifiers established pursuant to Article 30, including, where appropriate, the exchange of data. Where the competent authority of one Member State suspects or detects a fraud, it shall, where appropriate, inform the other Member States. 2. The Commission shall ensure that a Union database is put in place to enable the tracing of liquid and gaseous transport fuels that are eligible for being counted towards the numerator referred to in point (b) of Article 27(1) or that are taken into account for the purposes referred to in points (a), (b), and (c) of the first subparagraph of Article 29(1). Member States shall require the relevant economic operators to enter into that database information on the transactions made and the sustainability characteristics of those fuels, including their life-cycle greenhouse gas emissions, starting from their point of production to the fuel supplier that places the fuel on the market. A Member State may set up a national database that is linked to the Union database ensuring that information entered is instantly transferred between the databases. Fuel suppliers shall enter the information necessary to verify compliance with the requirements laid down in the first and fourth subparagraphs of Article 25(1) into the relevant database. 3. By 31 December 2021, Member States shall take measures to ensure the availability of fuels from renewable sources for transport including with regard to publicly accessible high-power recharging points and other refuelling infrastructure as provided for in their national policy frameworks in accordance with Directive 2014/94/EU. 4. Member States shall have access to the Union database referred to in paragraph 2 of this Article. They shall take measures to ensure that economic operators enter accurate information into the relevant database. The Commission shall require the schemes that are the subject of a decision pursuant to Article 30(4) of this Directive to verify compliance with that requirement when checking compliance with the sustainability criteria for biofuels, bioliquids and biomass fuels. It shall publish, every two years, aggregated information from the Union database pursuant to Annex VIII to Regulation (EU) 2018/1999. 5. By 31 December 2021, the Commission shall adopt delegated acts in accordance with Article 35 to supplement this Directive by specifying the methodology to determine the share of biofuel, and biogas for transport, resulting from biomass being processed with fossil fuels in a common process, and by specifying the methodology for assessing greenhouse gas emissions savings from renewable liquid and gaseous transport fuels of non-biological origin and from recycled carbon fuels, which shall ensure that credit for avoided emissions is not given for CO2 the capture of which has already received an emission credit under other provisions of law. 6. By 25 June 2019 and every two years thereafter, the Commission shall review the list of feedstock set out in Parts A and B of Annex IX with a view to adding feedstock in accordance with the principles set out in the third subparagraph. The Commission is empowered to adopt delegated acts in accordance with Article 35 to amend the list of feedstock set out in Parts A and B of Annex IX by adding, but not removing, feedstock. Feedstock that can be processed only with advanced technologies shall be added to Part A of Annex IX. Feedstock that can be processed into biofuels, or biogas for transport, with mature technologies shall be added to Part B of Annex IX. Such delegated acts shall be based on an analysis of the potential of the raw material as feedstock for the production of biofuels and biogas for transport, taking into account all of the following: (a) the principles of the circular economy and of the waste hierarchy established in Directive 2008/98/EC; (b) the Union sustainability criteria laid down in Article 29(2) to (7); (c) the need to avoid significant distortive effects on markets for (by-)products, wastes or residues; (d) the potential for delivering substantial greenhouse gas emissions savings compared to fossil fuels based on a life-cycle assessment of emissions; (e) the need to avoid negative impacts on the environment and biodiversity; (f) the need to avoid creating an additional demand for land. 7. By 31 December 2025, in the context of the biennial assessment of progress made pursuant to Regulation (EU) 2018/1999, the Commission shall assess whether the obligation relating to advanced biofuels and biogas produced from feedstock listed in Part A of Annex IX laid down in the fourth subparagraph of Article 25(1) effectively stimulates innovation and ensures greenhouse gas emissions savings in the transport sector. The Commission shall analyse in that assessment whether the application of this Article effectively avoids double accounting of renewable energy. The Commission shall, if appropriate, submit a proposal to amend the obligation relating to advanced biofuels and biogas produced from feedstock listed in Part A of Annex IX laid down in the fourth subparagraph of Article 25(1). Article 29 Sustainability and greenhouse gas emissions saving criteria for biofuels, bioliquids and biomass fuels 1. Energy from biofuels, bioliquids and biomass fuels shall be taken into account for the purposes referred to in points (a), (b) and (c) of this subparagraph only if they fulfil the sustainability and the greenhouse gas emissions saving criteria laid down in paragraphs 2 to 7 and 10: (a) contributing towards the Union target set in Article 3(1) and the renewable energy shares of Member States; (b) measuring compliance with renewable energy obligations, including the obligation laid down in Article 25; (c) eligibility for financial support for the consumption of biofuels, bioliquids and biomass fuels. However, biofuels, bioliquids and biomass fuels produced from waste and residues, other than agricultural, aquaculture, fisheries and forestry residues, are required to fulfil only the greenhouse gas emissions saving criteria laid down in paragraph 10 in order to be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph. This subparagraph shall also apply to waste and residues that are first processed into a product before being further processed into biofuels, bioliquids and biomass fuels. Electricity, heating and cooling produced from municipal solid waste shall not be subject to the greenhouse gas emissions saving criteria laid down in paragraph 10. Biomass fuels shall fulfil the sustainability and greenhouse gas emissions saving criteria laid down in paragraphs 2 to 7 and 10 if used in installations producing electricity, heating and cooling or fuels with a total rated thermal input equal to or exceeding 20 MW in the case of solid biomass fuels, and with a total rated thermal input equal to or exceeding 2 MW in the case of gaseous biomass fuels. Member States may apply the sustainability and greenhouse gas emissions saving criteria to installations with lower total rated thermal input. The sustainability and the greenhouse gas emissions saving criteria laid down in paragraphs 2 to 7 and 10 shall apply irrespective of the geographical origin of the biomass. 2. Biofuels, bioliquids and biomass fuels produced from waste and residues derived not from forestry but from agricultural land shall be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 only where operators or national authorities have monitoring or management plans in place in order to address the impacts on soil quality and soil carbon. Information about how those impacts are monitored and managed shall be reported pursuant to Article 30(3). 3. Biofuels, bioliquids and biomass fuels produced from agricultural biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall not be made from raw material obtained from land with a high biodiversity value, namely land that had one of the following statuses in or after January 2008, whether or not the land continues to have that status: (a) primary forest and other wooded land, namely forest and other wooded land of native species, where there is no clearly visible indication of human activity and the ecological processes are not significantly disturbed; (b) highly biodiverse forest and other wooded land which is species-rich and not degraded, or has been identified as being highly biodiverse by the relevant competent authority, unless evidence is provided that the production of that raw material did not interfere with those nature protection purposes; (c) areas designated: (i) by law or by the relevant competent authority for nature protection purposes; or (ii) for the protection of rare, threatened or endangered ecosystems or species recognised by international agreements or included in lists drawn up by intergovernmental organisations or the International Union for the Conservation of Nature, subject to their recognition in accordance with the first subparagraph of Article 30(4), unless evidence is provided that the production of that raw material did not interfere with those nature protection purposes; (d) highly biodiverse grassland spanning more than one hectare that is: (i) natural, namely grassland that would remain grassland in the absence of human intervention and that maintains the natural species composition and ecological characteristics and processes; or (ii) non-natural, namely grassland that would cease to be grassland in the absence of human intervention and that is species-rich and not degraded and has been identified as being highly biodiverse by the relevant competent authority, unless evidence is provided that the harvesting of the raw material is necessary to preserve its status as highly biodiverse grassland. The Commission may adopt implementing acts further specifying the criteria by which to determine which grassland are to be covered by point (d) of the first subparagraph of this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). 4. Biofuels, bioliquids and biomass fuels produced from agricultural biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall not be made from raw material obtained from land with high-carbon stock, namely land that had one of the following statuses in January 2008 and no longer has that status: (a) wetlands, namely land that is covered with or saturated by water permanently or for a significant part of the year; (b) continuously forested areas, namely land spanning more than one hectare with trees higher than five metres and a canopy cover of more than 30 %, or trees able to reach those thresholds in situ; (c) land spanning more than one hectare with trees higher than five metres and a canopy cover of between 10 % and 30 %, or trees able to reach those thresholds in situ, unless evidence is provided that the carbon stock of the area before and after conversion is such that, when the methodology laid down in Part C of Annex V is applied, the conditions laid down in paragraph 10 of this Article would be fulfilled. This paragraph shall not apply if, at the time the raw material was obtained, the land had the same status as it had in January 2008. 5. Biofuels, bioliquids and biomass fuels produced from agricultural biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall not be made from raw material obtained from land that was peatland in January 2008, unless evidence is provided that the cultivation and harvesting of that raw material does not involve drainage of previously undrained soil. 6. Biofuels, bioliquids and biomass fuels produced from forest biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall meet the following criteria to minimise the risk of using forest biomass derived from unsustainable production: (a) the country in which forest biomass was harvested has national or sub-national laws applicable in the area of harvest as well as monitoring and enforcement systems in place ensuring: (i) the legality of harvesting operations; (ii) forest regeneration of harvested areas; (iii) that areas designated by international or national law or by the relevant competent authority for nature protection purposes, including in wetlands and peatlands, are protected; (iv) that harvesting is carried out considering maintenance of soil quality and biodiversity with the aim of minimising negative impacts; and (v) that harvesting maintains or improves the long-term production capacity of the forest; (b) when evidence referred to in point (a) of this paragraph is not available, the biofuels, bioliquids and biomass fuels produced from forest biomass shall be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 if management systems are in place at forest sourcing area level ensuring: (i) the legality of harvesting operations; (ii) forest regeneration of harvested areas; (iii) that areas designated by international or national law or by the relevant competent authority for nature protection purposes, including in wetlands and peatlands, are protected unless evidence is provided that the harvesting of that raw material does not interfere with those nature protection purposes; (iv) that harvesting is carried out considering the maintenance of soil quality and biodiversity with the aim of minimising negative impacts; and (v) that harvesting maintains or improves the long-term production capacity of the forest. 7. Biofuels, bioliquids and biomass fuels produced from forest biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall meet the following land-use, land-use change and forestry (LULUCF) criteria: (a) the country or regional economic integration organisation of origin of the forest biomass: (i) is a Party to the Paris Agreement; (ii) has submitted a nationally determined contribution (NDC) to the United Nations Framework Convention on Climate Change (UNFCCC), covering emissions and removals from agriculture, forestry and land use which ensures that changes in carbon stock associated with biomass harvest are accounted towards the country's commitment to reduce or limit greenhouse gas emissions as specified in the NDC; or (iii) has national or sub-national laws in place, in accordance with Article 5 of the Paris Agreement, applicable in the area of harvest, to conserve and enhance carbon stocks and sinks, and providing evidence that reported LULUCF-sector emissions do not exceed removals; (b) where evidence referred to in point (a) of this paragraph is not available, the biofuels, bioliquids and biomass fuels produced from forest biomass shall be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 if management systems are in place at forest sourcing area level to ensure that carbon stocks and sinks levels in the forest are maintained, or strengthened over the long term. 8. By 31 January 2021, the Commission shall adopt implementing acts establishing the operational guidance on the evidence for demonstrating compliance with the criteria laid down in paragraphs 6 and 7 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). 9. By 31 December 2026, the Commission shall assess whether the criteria laid down in paragraphs 6 and 7 effectively minimise the risk of using forest biomass derived from unsustainable production and address LULUCF criteria, on the basis of the available data. The Commission shall, if appropriate, submit a legislative proposal to amend the criteria laid down in paragraphs 6 and 7 for the period after 2030. 10. The greenhouse gas emission savings from the use of biofuels, bioliquids and biomass fuels taken into account for the purposes referred to in paragraph 1 shall be: (a) at least 50 % for biofuels, biogas consumed in the transport sector, and bioliquids produced in installations in operation on or before 5 October 2015; (b) at least 60 % for biofuels, biogas consumed in the transport sector, and bioliquids produced in installations starting operation from 6 October 2015 until 31 December 2020; (c) at least 65 % for biofuels, biogas consumed in the transport sector, and bioliquids produced in installations starting operation from 1 January 2021; (d) at least 70 % for electricity, heating and cooling production from biomass fuels used in installations starting operation from 1 January 2021 until 31 December 2025, and 80 % for installations starting operation from 1 January 2026. An installation shall be considered to be in operation once the physical production of biofuels, biogas consumed in the transport sector and bioliquids, and the physical production of heating and cooling and electricity from biomass fuels has started. The greenhouse gas emission savings from the use of biofuels, biogas consumed in the transport sector, bioliquids and biomass fuels used in installations producing heating, cooling and electricity shall be calculated in accordance with Article 31(1). 11. Electricity from biomass fuels shall be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 only if it meets one or more of the following requirements: (a) it is produced in installations with a total rated thermal input below 50 MW; (b) for installations with a total rated thermal input from 50 to 100 MW, it is produced applying high-efficiency cogeneration technology, or, for electricity-only installations, meeting an energy efficiency level associated with the best available techniques (BAT-AEELs) as defined in Commission Implementing Decision (EU) 2017/1442 (26); (c) for installations with a total rated thermal input above 100 MW, it is produced applying high-efficiency cogeneration technology, or, for electricity-only installations, achieving an net-electrical efficiency of at least 36 %; (d) it is produced applying Biomass CO2 Capture and Storage. For the purposes of points (a), (b) and (c) of the first subparagraph of paragraph 1 of this Article, electricity-only-installations shall be taken into account only if they do not use fossil fuels as a main fuel and only if there is no cost-effective potential for the application of high-efficiency cogeneration technology according to the assessment in accordance with Article 14 of Directive 2012/27/EU. For the purposes of points (a) and (b) of the first subparagraph of paragraph 1 of this Article, this paragraph shall apply only to installations starting operation or converted to the use of biomass fuels after 25 December 2021. For the purposes of point (c) of the first subparagraph of paragraph 1 of this Article, this paragraph shall be without prejudice to support granted under support schemes in accordance with Article 4 approved by 25 December 2021. Member States may apply higher energy efficiency requirements than those referred in the first subparagraph to installations with lower rated thermal input. The first subparagraph shall not apply to electricity from installations which are the object of a specific notification by a Member State to the Commission based on the duly substantiated existence of risks for the security of supply of electricity. Upon assessment of the notification, the Commission shall adopt a decision taking into account the elements included therein. 12. For the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 of this Article, and without prejudice to Articles 25 and 26, Member States shall not refuse to take into account, on other sustainability grounds, biofuels and bioliquids obtained in compliance with this Article. This paragraph shall be without prejudice to public support granted under support schemes approved before 24 December 2018. 13. For the purposes referred to in point (c) of the first subparagraph of paragraph 1 of this Article, Member States may derogate, for a limited period of time, from the criteria laid down in paragraphs 2 to 7 and 10 and 11 of this Article by adopting different criteria for: (a) installations located in an outermost region as referred to in Article 349 TFEU to the extent that such facilities produce electricity or heating or cooling from biomass fuels; and (b) biomass fuels used in the installations referred to in point (a) of this subparagraph, irrespective of the place of origin of that biomass, provided that such criteria are objectively justified on the grounds that their aim is to ensure, for that outermost region, a smooth phase-in of the criteria laid down in paragraphs 2 to 7 and 10 and 11 of this Article and thereby incentivise the transition from fossil fuels to sustainable biomass fuels. The different criteria referred to in this paragraph shall be subject to a specific notification by the relevant Member State to the Commission. 14. For the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1, Member States may establish additional sustainability criteria for biomass fuels. By 31 December 2026, the Commission shall assess the impact of such additional criteria on the internal market, accompanied, if necessary, by a proposal to ensure harmonisation thereof. Article 30 Verification of compliance with the sustainability and greenhouse gas emissions saving criteria 1. Where biofuels, bioliquids and biomass fuels, or other fuels that are eligible for counting towards the numerator referred to in point (b) of Article 27(1), are to be taken into account for the purposes referred to in Articles 23 and 25 and in points (a), (b) and (c) of the first subparagraph of Article 29(1), Member States shall require economic operators to show that the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10) have been fulfilled. For those purposes, they shall require economic operators to use a mass balance system which: (a) allows consignments of raw material or fuels with differing sustainability and greenhouse gas emissions saving characteristics to be mixed for instance in a container, processing or logistical facility, transmission and distribution infrastructure or site; (b) allows consignments of raw material with differing energy content to be mixed for the purposes of further processing, provided that the size of consignments is adjusted according to their energy content; (c) requires information about the sustainability and greenhouse gas emissions saving characteristics and sizes of the consignments referred to in point (a) to remain assigned to the mixture; and (d) provides for the sum of all consignments withdrawn from the mixture to be described as having the same sustainability characteristics, in the same quantities, as the sum of all consignments added to the mixture and requires that this balance be achieved over an appropriate period of time. The mass balance system shall ensure that each consignment is counted only once in point (a), (b) or (c) of the first subparagraph of Article 7(1) for the purposes of calculating the gross final consumption of energy from renewable sources and shall include information on whether support has been provided for the production of that consignment, and if so, on the type of support scheme. 2. Where a consignment is processed, information on the sustainability and greenhouse gas emissions saving characteristics of the consignment shall be adjusted and assigned to the output in accordance with the following rules: (a) when the processing of a consignment of raw material yields only one output that is intended for the production of biofuels, bioliquids or biomass fuels, renewable liquid and gaseous transport fuels of non-biological origin, or recycled carbon fuels, the size of the consignment and the related quantities of sustainability and greenhouse gas emissions saving characteristics shall be adjusted applying a conversion factor representing the ratio between the mass of the output that is intended for such production and the mass of the raw material entering the process; (b) when the processing of a consignment of raw material yields more than one output that is intended for the production of biofuels, bioliquids or biomass fuels, renewable liquid and gaseous transport fuels of non-biological origin, or recycled carbon fuels, for each output a separate conversion factor shall be applied and a separate mass balance shall be used. 3. Member States shall take measures to ensure that economic operators submit reliable information regarding the compliance with the greenhouse gas emissions savings thresholds set in, and adopted pursuant to, Article 25(2), and with the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10), and that economic operators make available to the relevant Member State, upon request, the data that were used to develop the information. Member States shall require economic operators to arrange for an adequate standard of independent auditing of the information submitted, and to provide evidence that this has been done. In order to comply with point (a) of Article 29(6) and point (a) of Article 29(7), the first or second party auditing may be used up to the first gathering point of the forest biomass. The auditing shall verify that the systems used by economic operators are accurate, reliable and protected against fraud, including verification ensuring that materials are not intentionally modified or discarded so that the consignment or part thereof could become a waste or residue. It shall evaluate the frequency and methodology of sampling and the robustness of the data. The obligations laid down in this paragraph shall apply regardless of whether the biofuels, bioliquids, biomass fuels, renewable liquid and gaseous transport fuels of non-biological origin, or recycled carbon fuels are produced within the Union or are imported. Information about the geographic origin and feedstock type of biofuels, bioliquids and biomass fuels per fuel supplier shall be made available to consumers on the websites of operators, suppliers or the relevant competent authorities and shall be updated on an annual basis. Member States shall submit to the Commission, in aggregated form, the information referred to in the first subparagraph of this paragraph. The Commission shall publish that information on the e-reporting platform referred to in Article 28 of Regulation (EU) 2018/1999 in summary form preserving the confidentiality of commercially sensitive information. 4. The Commission may decide that voluntary national or international schemes setting standards for the production of biofuels, bioliquids or biomass fuels, or other fuels that are eligible for counting towards the numerator referred to in point (b) of Article 27(1), provide accurate data on greenhouse gas emission savings for the purposes of Article 25(2) and Article 29(10), demonstrate compliance with Article 27(3) and Article 28(2) and (4), or demonstrate that consignments of biofuels, bioliquids or biomass fuels comply with the sustainability criteria laid down in Article 29(2) to (7). When demonstrating that the criteria laid down in Article 29(6) and (7) are met, the operators may provide the required evidence directly at sourcing area level. The Commission may recognise areas for the protection of rare, threatened or endangered ecosystems or species recognised by international agreements or included in lists drawn up by intergovernmental organisations or the International Union for the Conservation of Nature for the purposes of point (c)(ii) of the first subparagraph of Article 29(3). The Commission may decide that those schemes contain accurate information on measures taken for soil, water and air protection, for the restoration of degraded land, for the avoidance of excessive water consumption in areas where water is scarce, and for certification of biofuels, bioliquids and biomass fuels with low indirect land-use change-risk. 5. The Commission shall adopt decisions under paragraph 4 of this Article by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). Such decisions shall be valid for a period of no more than five years. The Commission shall require that each voluntary scheme on which a decision has been adopted under paragraph 4 submit annually by 30 April a report to the Commission covering each of the points set out in Annex IX to Regulation (EU) 2018/1999. The report shall cover the preceding calendar year. The requirement to submit a report shall apply only to voluntary schemes that have operated for at least 12 months. The Commission shall make the reports drawn up by the voluntary schemes available, in an aggregated form or in full if appropriate, on the e-reporting platform referred to in Article 28 of Regulation (EU) 2018/1999. 6. Member States may set up national schemes where compliance with the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10) and with the greenhouse gas emissions savings thresholds for renewable liquid and gaseous transport fuels of non-biological origin and recycled carbon fuels set in, and adopted pursuant to, Article 25(2) and in accordance with Article 28(5) is verified throughout the entire chain of custody involving competent national authorities. A Member State may notify such a national scheme to the Commission. The Commission shall give priority to the assessment of such a scheme in order to facilitate mutual bilateral and multilateral recognition of schemes for verification of compliance with the sustainability and greenhouse gas emissions saving criteria for biofuels, bioliquids and biomass fuels and with the greenhouse gas emissions savings thresholds for other fuels that are eligible for counting towards the numerator referred to in point (b) of Article 27(1). The Commission may decide, by means of implementing acts, whether such a notified national scheme complies with the conditions laid down in this Directive. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). Where the decision is positive, schemes established in accordance with this Article shall not refuse mutual recognition with that Member State's scheme, as regards verification of compliance with the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10) and the greenhouse gas emissions savings thresholds set in, and adopted pursuant to, Article 25(2). 7. The Commission shall adopt decisions under paragraph 4 of this Article only if the scheme in question meets adequate standards of reliability, transparency and independent auditing and provides adequate assurances that no materials have been intentionally modified or discarded so that the consignment or part thereof would fall under Annex IX. In the case of schemes to measure greenhouse gas emissions savings, such schemes shall also comply with the methodological requirements set out in Annex V or VI. Lists of areas of high biodiversity value as referred to in point (c)(ii) of the first subparagraph of Article 29(3) shall meet adequate standards of objectivity and coherence with internationally recognised standards and provide for appropriate appeal procedures. The voluntary schemes referred to in paragraph 4 shall, at least annually, publish a list of their certification bodies used for independent auditing, indicating for each certification body by which entity or national public authority it was recognised and which entity or national public authority is monitoring it. 8. In order to ensure that compliance with the sustainability and greenhouse gas emissions saving criteria as well as with the provisions on low or high direct and indirect land-use change-risk biofuels, bioliquids and biomass fuels is verified in an efficient and harmonised manner and in particular to prevent fraud, the Commission shall adopt implementing acts specifying detailed implementing rules, including adequate standards of reliability, transparency and independent auditing and require all voluntary schemes to apply those standards. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). In those implementing acts, the Commission shall pay particular attention to the need to minimise administrative burden. The implementing acts shall set a time frame by which voluntary schemes are required to implement the standards. The Commission may repeal decisions recognising voluntary schemes pursuant to paragraph 4 in the event that those schemes fail to implement such standards in the time frame provided for. Where a Member State raises concerns that a voluntary scheme does not operate in accordance with the standards of reliability, transparency and independent auditing that constitute the basis for decisions under paragraph 4, the Commission shall investigate the matter and take appropriate action. 9. Where an economic operator provides evidence or data obtained in accordance with a scheme that has been the subject of a decision pursuant to paragraph 4 or 6 of this Article, to the extent covered by that decision, a Member State shall not require the supplier to provide further evidence of compliance with the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10). Competent authorities of the Member States shall supervise the operation of certification bodies that are conducting independent auditing under a voluntary scheme. Certification bodies shall submit, upon the request of competent authorities, all relevant information necessary to supervise the operation, including the exact date, time and location of audits. Where Member States find issues of non-conformity, they shall inform the voluntary scheme without delay. 10. At the request of a Member State, which may be based on the request of an economic operator, the Commission shall, on the basis of all available evidence, examine whether the sustainability and greenhouse gas emissions saving criteria laid down in Article 29(2) to (7) and (10) in relation to a source of biofuels, bioliquids and biomass fuels, and the greenhouse gas emissions savings thresholds set in, and adopted pursuant to, Article 25(2), have been met. Within six months of receipt of such a request and in accordance with the examination procedure referred to in Article 34(3), the Commission shall, by means of implementing acts, decide whether the Member State concerned may either: (a) take into account biofuels, bioliquids, biomass fuels and other fuels that are eligible for counting towards the numerator referred to in point (b) of Article 27(1) from that source for the purposes referred to in points (a), (b) and (c) of the first subparagraph of Article 29(1); or (b) by way of derogation from paragraph 9 of this Article, require suppliers of the source of biofuels, bioliquids, biomass fuels and other fuels that are eligible for counting towards the numerator referred to in point (b) of Article 27(1) to provide further evidence of compliance with those sustainability and greenhouse gas emissions saving criteria and those greenhouse gas emissions savings thresholds. Article 31 Calculation of the greenhouse gas impact of biofuels, bioliquids and biomass fuels 1. For the purposes of Article 29(10), the greenhouse gas emissions saving from the use of biofuel, bioliquids and biomass fuels shall be calculated in one of the following ways: (a) where a default value for greenhouse gas emissions saving for the production pathway is laid down in Part A or B of Annex V for biofuels and bioliquids and in Part A of Annex VI for biomass fuels where the el value for those biofuels or bioliquids calculated in accordance with point 7 of Part C of Annex V and for those biomass fuels calculated in accordance with point 7 of Part B of Annex VI is equal to or less than zero, by using that default value; (b) by using an actual value calculated in accordance with the methodology laid down in Part C of Annex V for biofuels and bioliquids and in Part B of Annex VI for biomass fuels; (c) by using a value calculated as the sum of the factors of the formulas referred to in point 1 of Part C of Annex V, where disaggregated default values in Part D or E of Annex V may be used for some factors, and actual values, calculated in accordance with the methodology laid down in Part C of Annex V, are used for all other factors; (d) by using a value calculated as the sum of the factors of the formulas referred to in point 1 of Part B of Annex VI, where disaggregated default values in Part C of Annex VI may be used for some factors, and actual values, calculated in accordance with the methodology laid down in Part B of Annex VI, are used for all other factors. 2. Member States may submit to the Commission reports including information on the typical greenhouse gas emissions from the cultivation of agricultural raw materials of the areas on their territory classified as level 2 in the nomenclature of territorial units for statistics (NUTS) or as a more disaggregated NUTS level in accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council (27). Those reports shall be accompanied by a description of the method and data sources used to calculate the level of emissions. That method shall take into account soil characteristics, climate and expected raw material yields. 3. In the case of territories outside the Union, reports equivalent to those referred to in paragraph 2 and drawn up by competent bodies may be submitted to the Commission. 4. The Commission may, by means of implementing acts, decide that the reports referred to in paragraphs 2 and 3 of this Article contain accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of agriculture biomass feedstock produced in the areas included in such reports for the purposes of Article 29(10). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). Those data may, pursuant to such decisions, be used instead of the disaggregated default values for cultivation laid down in Part D or E of Annex V for biofuels and bioliquids and in Part C of Annex VI for biomass fuels. 5. The Commission shall review Annexes V and VI with a view, where justified, to adding or revising values for biofuel, bioliquid and biomass fuel production pathways. Those reviews shall also consider modifying the methodology laid down in Part C of Annex V and in Part B of Annex VI. The Commission is empowered to adopt delegated acts pursuant to Article 35 to amend, where appropriate, Annexes V and VI by adding or revising the default values or modifying the methodology. In the case of an adaptation of, or addition to, the list of default values in Annexes V and VI: (a) where the contribution of a factor to overall emissions is small, where there is limited variation, or where the cost or difficulty of establishing actual values is high, the default values shall be typical of normal production processes; (b) in all other cases, the default values shall be conservative compared to normal production processes. 6. Where necessary in order to ensure the uniform application of Part C of Annex V and Part B of Annex VI, the Commission may adopt implementing acts setting out detailed technical specifications including definitions, conversion factors, the calculation of annual cultivation emissions or emission savings caused by changes above and below-ground carbon stocks on already cultivated land, the calculation of emission savings from CO2 capture, CO2 replacement and CO2 geological storage. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). Article 32 Implementing acts The implementing acts referred to in the second subparagraph of Article 29(3), Article 29(8), the first subparagraph of Article 30(5), the second subparagraph of Article 30(6), the first subparagraph of Article 30(8), the first subparagraph of Article 31(4) and Article 31(6) of this Directive, shall take full account of the provisions relating to greenhouse gas emissions reductions in accordance with Article 7a of Directive 98/70/EC of the European Parliament and of the Council (28). Article 33 Monitoring by the Commission 1. The Commission shall monitor the origin of biofuels, bioliquids and biomass fuels consumed in the Union and the impact of their production, including the impact as a result of displacement, on land use in the Union and in the main third countries of supply. Such monitoring shall be based on Member States' integrated national energy and climate plans and corresponding progress reports pursuant to Articles 3, 17 and 20 of Regulation (EU) 2018/1999, and those of relevant third countries, intergovernmental organisations, scientific studies and any other relevant pieces of information. The Commission shall also monitor the commodity price changes associated with the use of biomass for energy and any associated positive and negative effects on food security. 2. The Commission shall maintain a dialogue and exchange information with third countries and biofuel, bioliquid and biomass fuel producers, consumer organisations and civil society concerning the general implementation of the measures in this Directive relating to biofuels, bioliquids and biomass fuels. It shall, within that framework, pay particular attention to the impact that biofuel, bioliquid and biomass fuel production may have on food prices. 3. In 2026, the Commission shall submit, if appropriate, a legislative proposal on the regulatory framework for the promotion of energy from renewable sources for the period after 2030. That proposal shall take into account the experience of the implementation of this Directive, including its sustainability and greenhouse gas emissions saving criteria, and technological developments in energy from renewable sources. 4. In 2032, the Commission shall publish a report reviewing the application of this Directive. Article 34 Committee procedure 1. The Commission shall be assisted by the Energy Union Committee established by Article 44 of Regulation (EU) 2018/1999. 2. Notwithstanding paragraph 1, for matters relating to the sustainability of biofuels, bioliquids and biomass fuels, the Commission shall be assisted by the Committee on the Sustainability of Biofuels, Bioliquids and Biomass fuels. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 35 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in the second subparagraph of Article 8(3), the second subparagraph of Article 25(2), the fourth subparagraph of Article 26(2), the fifth subparagraph of Article 26(2), point (c) of Article 27(1), the seventh subparagraph of Article 27(3), Article 28(5), the second subparagraph of Article 28(6), and the second subparagraph of Article 31(5) shall be conferred on the Commission for a period of five years from 24 December 2018. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The power to adopt delegated acts referred to in the fifth subparagraph of Article 7(3) shall be conferred on the Commission for a period of two years from 24 December 2018. 4. The delegation of power referred to in the fifth subparagraph of Article 7(3), the second subparagraph of Article 8(3), the second subparagraph of Article 25(2), the fourth subparagraph of Article 26(2), the fifth subparagraph of Article 26(2), point (c) of Article 27(1), the seventh subparagraph of Article 27(3), Article 28(5), the second subparagraph of Article 28(6), and the second subparagraph of Article 31(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 5. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 6. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 7. A delegated act adopted pursuant to the fifth subparagraph of Article 7(3), the second subparagraph of Article 8(3), the second subparagraph of Article 25(2), the fourth subparagraph of Article 26(2), the fifth subparagraph of Article 26(2), point (c) of Article 27(1), the seventh subparagraph of Article 27(3), Article 28(5), the second subparagraph of Article 28(6), and the second subparagraph of Article 31(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 36 Transposition 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Articles 2 to 13, 15 to 31 and 37 and Annexes II, III and V to IX, by 30 June 2021. They shall immediately communicate the text of those measures to the Commission. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. 3. This Directive shall not affect the application of the derogations pursuant to Union law on the internal market for electricity. Article 37 Repeal Directive 2009/28/EC, as amended by the Directives listed in Part A of Annex X, is repealed with effect from 1 July 2021, without prejudice to the obligations of the Member States relating to the time-limits for the transposition into national law of the Directives set out in Part B of Annex X and without prejudice to the obligations of Member States in 2020 as laid down in Article 3(1) and set out in Part A of Annex I to Directive 2009/28/EC. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex XI. Article 38 Entry into force This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Union. Article 39 Addressees This Directive is addressed to the Member States. Done at Strasbourg, 11 December 2018. For the European Parliament The President A. TAJANI For the Council The President J. BOGNER-STRAUSS (1) OJ C 246, 28.7.2017, p. 55. (2) OJ C 342, 12.10.2017, p. 79. (3) Position of the European Parliament of 13 November 2018 (not yet published in the Official Journal) and decision of the Council of 4 December 2018. (4) Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140, 5.6.2009, p. 16). (5) See Annex X, Part A. (6) Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (see page 1 of this Official Journal). (7) Regulation (EC) No 1099/2008 of the European Parliament and of the Council of 22 October 2008 on energy statistics (OJ L 304, 14.11.2008, p. 1). (8) Directive 2001/77/EC of the European Parliament and of the Council of 27 September 2001 on the promotion of electricity produced from renewable energy sources in the internal electricity market (OJ L 283, 27.10.2001, p. 33). (9) Directive 2003/30/EC of the European Parliament and of the Council of 8 May 2003 on the promotion of the use of biofuels or other renewable fuels for transport (OJ L 123, 17.5.2003, p. 42). (10) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3). (11) OJ L 198, 20.7.2006, p. 18. (12) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1). (13) Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, p. 22). (14) Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings (OJ L 153, 18.6.2010, p. 13). (15) Directive (EU) 2015/1513 of the European Parliament and of the Council of 9 September 2015 amending Directive 98/70/EC relating to the quality of petrol and diesel fuels and amending Directive 2009/28/EC on the promotion of the use of energy from renewable sources (OJ L 239, 15.9.2015, p. 1). (16) Regulation (EU) No 525/2013 of the European Parliament and of the Council of 21 May 2013 on a mechanism for monitoring and reporting greenhouse gas emissions and for reporting other information at national and Union level relevant to climate change and repealing Decision No 280/2004/EC (OJ L 165, 18.6.2013, p. 13). (17) Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26). (18) OJ L 123, 12.5.2016, p. 1. (19) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (20) OJ C 369, 17.12.2011, p. 14. (21) Council Directive 2013/18/EU of 13 May 2013 adapting Directive 2009/28/EC of the European Parliament and of the Council on the promotion of the use of energy from renewable sources, by reason of the accession of the Republic of Croatia (OJ L 158, 10.6.2013, p. 230). (22) Directive 2009/72/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in electricity and repealing Directive 2003/54/EC (OJ L 211, 14.8.2009, p. 55). (23) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (24) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (25) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ L 211, 14.8.2009, p. 94). (26) Commission Implementing Decision (EU) 2017/1442 of 31 July 2017 establishing best available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council, for large combustion plants (OJ L 212, 17.8.2017, p. 1). (27) Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the establishment of a common classification of territorial units for statistics (NUTS) (OJ L 154, 21.6.2003, p. 1). (28) Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L 350, 28.12.1998, p. 58). ANNEX I NATIONAL OVERALL TARGETS FOR THE SHARE OF ENERGY FROM RENEWABLE SOURCES IN GROSS FINAL CONSUMPTION OF ENERGY IN 2020 (1) A. National overall targets Share of energy from renewable sources in gross final consumption of energy, 2005 (S2005) Target for share of energy from renewable sources in gross final consumption of energy, 2020 (S2020) Belgium 2,2 % 13 % Bulgaria 9,4 % 16 % Czech Republic 6,1 % 13 % Denmark 17,0 % 30 % Germany 5,8 % 18 % Estonia 18,0 % 25 % Ireland 3,1 % 16 % Greece 6,9 % 18 % Spain 8,7 % 20 % France 10,3 % 23 % Croatia 12,6 % 20 % Italy 5,2 % 17 % Cyprus 2,9 % 13 % Latvia 32,6 % 40 % Lithuania 15,0 % 23 % Luxembourg 0,9 % 11 % Hungary 4,3 % 13 % Malta 0,0 % 10 % Netherlands 2,4 % 14 % Austria 23,3 % 34 % Poland 7,2 % 15 % Portugal 20,5 % 31 % Romania 17,8 % 24 % Slovenia 16,0 % 25 % Slovak Republic 6,7 % 14 % Finland 28,5 % 38 % Sweden 39,8 % 49 % United Kingdom 1,3 % 15 % (1) In order to be able to achieve the national objectives set out in this Annex, it is underlined that the State aid guidelines for environmental protection recognise the continued need for national mechanisms of support for the promotion of energy from renewable sources. ANNEX II NORMALISATION RULE FOR ACCOUNTING FOR ELECTRICITY GENERATED FROM HYDROPOWER AND WIND POWER The following rule shall be applied for the purposes of accounting for electricity generated from hydropower in a given Member State: (QN(norm))(CN[(/(i)(N 14))(QiCi)] 15) where: N = reference year; QN(norm) = normalised electricity generated by all hydropower plants of the Member State in year N, for accounting purposes; Qi = the quantity of electricity actually generated in year i by all hydropower plants of the Member State measured in GWh, excluding production from pumped storage units using water that has previously been pumped uphill; Ci = the total installed capacity, net of pumped storage, of all hydropower plants of the Member State at the end of year i, measured in MW. The following rule shall be applied for the purposes of accounting for electricity generated from onshore wind power in a given Member State: (QN(norm))((CN CN 12)((/(i)(Nn))Qi(/(j)(Nn))(Cj Cj 12))) where: N = reference year; QN(norm) = normalised electricity generated by all onshore wind power plants of the Member State in year N, for accounting purposes; Qi = the quantity of electricity actually generated in year i by all onshore wind power plants of the Member State measured in GWh; Cj = the total installed capacity of all the onshore wind power plants of the Member State at the end of year j, measured in MW; n = 4 or the number of years preceding year N for which capacity and production data are available for the Member State in question, whichever is lower. The following rule shall be applied for the purposes of accounting for electricity generated from offshore wind power in a given Member State: (QN(norm))((CN CN 12)((/(i)(Nn))Qi(/(j)(Nn))(Cj Cj 12))) where: N = reference year; QN(norm) = normalised electricity generated by all offshore wind power plants of the Member State in year N, for accounting purposes; Qi = the quantity of electricity actually generated in year i by all offshore wind power plants of the Member State measured in GWh; Cj = the total installed capacity of all the offshore wind power plants of the Member State at the end of year j, measured in MW; n = 4 or the number of years preceding year N for which capacity and production data are available for the Member State in question, whichever is lower. ANNEX III ENERGY CONTENT OF FUELS Fuel Energy content by weight (lower calorific value, MJ/kg) Energy content by volume (lower calorific value, MJ/l) FUELS FROM BIOMASS AND/OR BIOMASS PROCESSING OPERATIONS Bio-Propane 46 24 Pure vegetable oil (oil produced from oil plants through pressing, extraction or comparable procedures, crude or refined but chemically unmodified) 37 34 Biodiesel - fatty acid methyl ester (methyl-ester produced from oil of biomass origin) 37 33 Biodiesel - fatty acid ethyl ester (ethyl-ester produced from oil of biomass origin) 38 34 Biogas that can be purified to natural gas quality 50 — Hydrotreated (thermochemically treated with hydrogen) oil of biomass origin, to be used for replacement of diesel 44 34 Hydrotreated (thermochemically treated with hydrogen) oil of biomass origin, to be used for replacement of petrol 45 30 Hydrotreated (thermochemically treated with hydrogen) oil of biomass origin, to be used for replacement of jet fuel 44 34 Hydrotreated oil (thermochemically treated with hydrogen) of biomass origin, to be used for replacement of liquefied petroleum gas 46 24 Co-processed oil (processed in a refinery simultaneously with fossil fuel) of biomass or pyrolysed biomass origin to be used for replacement of diesel 43 36 Co-processed oil (processed in a refinery simultaneously with fossil fuel) of biomass or pyrolysed biomass origin, to be used to replace petrol 44 32 Co-processed oil (processed in a refinery simultaneously with fossil fuel) of biomass or pyrolysed biomass origin, to be used to replace jet fuel 43 33 Co-processed oil (processed in a refinery simultaneously with fossil fuel) of biomass or pyrolysed biomass origin, to be used to replace liquefied petroleum gas 46 23 RENEWABLE FUELS THAT CAN BE PRODUCED FROM VARIOUS RENEWABLE SOURCES, INCLUDING BIOMASS Methanol from renewable sources 20 16 Ethanol from renewable sources 27 21 Propanol from renewable sources 31 25 Butanol from renewable sources 33 27 Fischer-Tropsch diesel (a synthetic hydrocarbon or mixture of synthetic hydrocarbons to be used for replacement of diesel) 44 34 Fischer-Tropsch petrol (a synthetic hydrocarbon or mixture of synthetic hydrocarbons produced from biomass, to be used for replacement of petrol) 44 33 Fischer-Tropsch jet fuel (a synthetic hydrocarbon or mixture of synthetic hydrocarbons produced from biomass, to be used for replacement of jet fuel) 44 33 Fischer-Tropsch liquefied petroleum gas (a synthetic hydrocarbon or mixture of synthetic hydrocarbons, to be used for replacement of liquefied petroleum gas 46 24 DME (dimethylether) 28 19 Hydrogen from renewable sources 120 — ETBE (ethyl-tertio-butyl-ether produced on the basis of ethanol) 36 (of which 37 % from renewable sources) 27 (of which 37 % from renewable sources) MTBE (methyl-tertio-butyl-ether produced on the basis of methanol) 35 (of which 22 % from renewable sources) 26 (of which 22 % from renewable sources) TAEE (tertiary-amyl-ethyl-ether produced on the basis of ethanol) 38 (of which 29 % from renewable sources) 29 (of which 29 % from renewable sources) TAME (tertiary-amyl-methyl-ether produced on the basis of methanol) 36 (of which 18 % from renewable sources) 28 (of which 18 % from renewable sources) THxEE (tertiary-hexyl-ethyl-ether produced on the basis of ethanol) 38 (of which 25 % from renewable sources) 30 (of which 25 % from renewable sources) THxME (tertiary-hexyl-methyl-ether produced on the basis of methanol) 38 of which 14 % from renewable sources) 30 (of which 14 % from renewable sources) FOSSIL FUELS Petrol 43 32 Diesel 43 36 ANNEX IV CERTIFICATION OF INSTALLERS The certification schemes or equivalent qualification schemes referred to in Article 18(3) shall be based on the following criteria: 1. The certification or qualification process shall be transparent and clearly defined by the Member States or by the administrative body that they appoint. 2. Installers of biomass, heat pump, shallow geothermal and solar photovoltaic and solar thermal energy shall be certified by an accredited training programme or training provider. 3. The accreditation of the training programme or provider shall be effected by Member States or by the administrative body that they appoint. The accrediting body shall ensure that the training programme offered by the training provider has continuity and regional or national coverage. The training provider shall have adequate technical facilities to provide practical training, including some laboratory equipment or corresponding facilities to provide practical training. The training provider shall also offer in addition to the basic training, shorter refresher courses on topical issues, including on new technologies, to enable life-long learning in installations. The training provider may be the manufacturer of the equipment or system, institutes or associations. 4. The training leading to certification or qualification of an installer shall include theoretical and practical parts. At the end of the training, the installer must have the skills required to install the relevant equipment and systems to meet the performance and reliability needs of the customer, incorporate quality craftsmanship, and comply with all applicable codes and standards, including energy and eco-labelling. 5. The training course shall end with an examination leading to a certificate or qualification. The examination shall include a practical assessment of successfully installing biomass boilers or stoves, heat pumps, shallow geothermal installations, solar photovoltaic or solar thermal installations. 6. The certification schemes or equivalent qualification schemes referred to in Article 18(3) shall take due account of the following guidelines: (a) Accredited training programmes should be offered to installers with work experience, who have undergone, or are undergoing, the following types of training: (i) in the case of biomass boiler and stove installers: training as a plumber, pipe fitter, heating engineer or technician of sanitary and heating or cooling equipment as a prerequisite; (ii) in the case of heat pump installers: training as a plumber or refrigeration engineer and have basic electrical and plumbing skills (cutting pipe, soldering pipe joints, gluing pipe joints, lagging, sealing fittings, testing for leaks and installation of heating or cooling systems) as a prerequisite; (iii) in the case of a solar photovoltaic or solar thermal installer: training as a plumber or electrician and have plumbing, electrical and roofing skills, including knowledge of soldering pipe joints, gluing pipe joints, sealing fittings, testing for plumbing leaks, ability to connect wiring, familiar with basic roof materials, flashing and sealing methods as a prerequisite; or (iv) a vocational training scheme to provide an installer with adequate skills corresponding to a three years education in the skills referred to in point (a), (b) or (c), including both classroom and workplace learning. (b) The theoretical part of the biomass stove and boiler installer training should give an overview of the market situation of biomass and cover ecological aspects, biomass fuels, logistics, fire protection, related subsidies, combustion techniques, firing systems, optimal hydraulic solutions, cost and profitability comparison as well as the design, installation and maintenance of biomass boilers and stoves. The training should also provide good knowledge of any European standards for technology and biomass fuels, such as pellets, and biomass related national and Union law. (c) The theoretical part of the heat pump installer training should give an overview of the market situation for heat pumps and cover geothermal resources and ground source temperatures of different regions, soil and rock identification for thermal conductivity, regulations on using geothermal resources, feasibility of using heat pumps in buildings and determining the most suitable heat pump system, and knowledge about their technical requirements, safety, air filtering, connection with the heat source and system layout. The training should also provide good knowledge of any European standards for heat pumps, and of relevant national and Union law. The installer should demonstrate the following key competences: (i) a basic understanding of the physical and operation principles of a heat pump, including characteristics of the heat pump circle: context between low temperatures of the heat sink, high temperatures of the heat source, and the efficiency of the system, determination of the coefficient of performance and seasonal performance factor (SPF); (ii) an understanding of the components and their function within a heat pump circle, including the compressor, expansion valve, evaporator, condenser, fixtures and fittings, lubricating oil, refrigerant, superheating and sub-cooling and cooling possibilities with heat pumps; and (iii) the ability to choose and size the components in typical installation situations, including determining the typical values of the heat load of different buildings and for hot water production based on energy consumption, determining the capacity of the heat pump on the heat load for hot water production, on the storage mass of the building and on interruptible current supply; determine the buffer tank component and its volume and integration of a second heating system. (d) The theoretical part of the solar photovoltaic and solar thermal installer training should give an overview of the market situation of solar products and cost and profitability comparisons, and cover ecological aspects, components, characteristics and dimensioning of solar systems, selection of accurate systems and dimensioning of components, determination of the heat demand, fire protection, related subsidies, as well as the design, installation and maintenance of solar photovoltaic and solar thermal installations. The training should also provide good knowledge of any European standards for technology, and certification such as Solar Keymark, and related national and Union law. The installer should demonstrate the following key competences: (i) the ability to work safely using the required tools and equipment and implementing safety codes and standards and to identify plumbing, electrical and other hazards associated with solar installations; (ii) the ability to identify systems and their components specific to active and passive systems, including the mechanical design, and to determine the components' location and system layout and configuration; (iii) the ability to determine the required installation area, orientation and tilt for the solar photovoltaic and solar water heater, taking account of shading, solar access, structural integrity, the appropriateness of the installation for the building or the climate and to identify different installation methods suitable for roof types and the balance of system equipment required for the installation; and (iv) for solar photovoltaic systems in particular, the ability to adapt the electrical design, including determining design currents, selecting appropriate conductor types and ratings for each electrical circuit, determining appropriate size, ratings and locations for all associated equipment and subsystems and selecting an appropriate interconnection point. (e) The installer certification should be time restricted, so that a refresher seminar or event would be necessary for continued certification. ANNEX V RULES FOR CALCULATING THE GREENHOUSE GAS IMPACT OF BIOFUELS, BIOLIQUIDS AND THEIR FOSSIL FUEL COMPARATORS A. TYPICAL AND DEFAULT VALUES FOR BIOFUELS IF PRODUCED WITH NO NET CARBON EMISSIONS FROM LAND-USE CHANGE Biofuel production pathway Greenhouse gas emissions saving – typical value Greenhouse gas emissions saving – default value sugar beet ethanol (no biogas from slop, natural gas as process fuel in conventional boiler) 67 % 59 % sugar beet ethanol (with biogas from slop, natural gas as process fuel in conventional boiler) 77 % 73 % sugar beet ethanol (no biogas from slop, natural gas as process fuel in CHP plant (*)) 73 % 68 % sugar beet ethanol (with biogas from slop, natural gas as process fuel in CHP plant (*)) 79 % 76 % sugar beet ethanol (no biogas from slop, lignite as process fuel in CHP plant (*)) 58 % 47 % sugar beet ethanol (with biogas from slop, lignite as process fuel in CHP plant (*)) 71 % 64 % corn (maize) ethanol (natural gas as process fuel in conventional boiler) 48 % 40 % corn (maize) ethanol, (natural gas as process fuel in CHP plant (*)) 55 % 48 % corn (maize) ethanol (lignite as process fuel in CHP plant (*)) 40 % 28 % corn (maize) ethanol (forest residues as process fuel in CHP plant (*)) 69 % 68 % other cereals excluding maize ethanol (natural gas as process fuel in conventional boiler) 47 % 38 % other cereals excluding maize ethanol (natural gas as process fuel in CHP plant (*)) 53 % 46 % other cereals excluding maize ethanol (lignite as process fuel in CHP plant (*)) 37 % 24 % other cereals excluding maize ethanol (forest residues as process fuel in CHP plant (*)) 67 % 67 % sugar cane ethanol 70 % 70 % the part from renewable sources of ethyl-tertio-butyl-ether (ETBE) Equal to that of the ethanol production pathway used the part from renewable sources of tertiary-amyl-ethyl-ether (TAEE) Equal to that of the ethanol production pathway used rape seed biodiesel 52 % 47 % sunflower biodiesel 57 % 52 % soybean biodiesel 55 % 50 % palm oil biodiesel (open effluent pond) 32 % 19 % palm oil biodiesel (process with methane capture at oil mill) 51 % 45 % waste cooking oil biodiesel 88 % 84 % animal fats from rendering biodiesel (**) 84 % 78 % hydrotreated vegetable oil from rape seed 51 % 47 % hydrotreated vegetable oil from sunflower 58 % 54 % hydrotreated vegetable oil from soybean 55 % 51 % hydrotreated vegetable oil from palm oil (open effluent pond) 34 % 22 % hydrotreated vegetable oil from palm oil (process with methane capture at oil mill) 53 % 49 % hydrotreated oil from waste cooking oil 87 % 83 % hydrotreated oil from animal fats from rendering (**) 83 % 77 % pure vegetable oil from rape seed 59 % 57 % pure vegetable oil from sunflower 65 % 64 % pure vegetable oil from soybean 63 % 61 % pure vegetable oil from palm oil (open effluent pond) 40 % 30 % pure vegetable oil from palm oil (process with methane capture at oil mill) 59 % 57 % pure oil from waste cooking oil 98 % 98 % (*) Default values for processes using CHP are valid only if all the process heat is supplied by CHP. (**) Applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1), for which emissions related to hygenisation as part of the rendering are not considered. B. ESTIMATED TYPICAL AND DEFAULT VALUES FOR FUTURE BIOFUELS THAT WERE NOT ON THE MARKET OR WERE ON THE MARKET ONLY IN NEGLIGIBLE QUANTITIES IN 2016, IF PRODUCED WITH NO NET CARBON EMISSIONS FROM LAND-USE CHANGE Biofuel production pathway Greenhouse gas emissions saving - typical value Greenhouse gas emissions saving - default value wheat straw ethanol 85 % 83 % waste wood Fischer-Tropsch diesel in free-standing plant 85 % 85 % farmed wood Fischer-Tropsch diesel in free-standing plant 82 % 82 % waste wood Fischer-Tropsch petrol in free-standing plant 85 % 85 % farmed wood Fischer-Tropsch petrol in free-standing plant 82 % 82 % waste wood dimethylether (DME) in free-standing plant 86 % 86 % farmed wood dimethylether (DME) in free-standing plant 83 % 83 % waste wood methanol in free-standing plant 86 % 86 % farmed wood methanol in free-standing plant 83 % 83 % Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 89 % 89 % Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 89 % 89 % dimethylether (DME) from black-liquor gasification integrated with pulp mill 89 % 89 % Methanol from black-liquor gasification integrated with pulp mill 89 % 89 % the part from renewable sources of methyl-tertio-butyl-ether (MTBE) Equal to that of the methanol production pathway used C. METHODOLOGY 1. Greenhouse gas emissions from the production and use of transport fuels, biofuels and bioliquids shall be calculated as follows: (a) greenhouse gas emissions from the production and use of biofuels shall be calculated as: E = eec + el + ep + etd + eu – esca – eccs – eccr, where E = total emissions from the use of the fuel; eec = emissions from the extraction or cultivation of raw materials; el = annualised emissions from carbon stock changes caused by land-use change; ep = emissions from processing; etd = emissions from transport and distribution; eu = emissions from the fuel in use; esca = emission savings from soil carbon accumulation via improved agricultural management; eccs = emission savings from CO2 capture and geological storage; and eccr = emission savings from CO2 capture and replacement. Emissions from the manufacture of machinery and equipment shall not be taken into account. (b) Greenhouse gas emissions from the production and use of bioliquids shall be calculated as for biofuels (E), but with the extension necessary for including the energy conversion to electricity and/or heat and cooling produced, as follows: (i) For energy installations delivering only heat: (ii) For energy installations delivering only electricity: where ECh,el = Total greenhouse gas emissions from the final energy commodity. E = Total greenhouse gas emissions of the bioliquid before end-conversion. ηel = The electrical efficiency, defined as the annual electricity produced divided by the annual bioliquid input based on its energy content. ηh = The heat efficiency, defined as the annual useful heat output divided by the annual bioliquid input based on its energy content. (iii) For the electricity or mechanical energy coming from energy installations delivering useful heat together with electricity and/or mechanical energy: (iv) For the useful heat coming from energy installations delivering heat together with electricity and/or mechanical energy: where: ECh,el = Total greenhouse gas emissions from the final energy commodity. E = Total greenhouse gas emissions of the bioliquid before end-conversion. ηel = The electrical efficiency, defined as the annual electricity produced divided by the annual fuel input based on its energy content. ηh = The heat efficiency, defined as the annual useful heat output divided by the annual fuel input based on its energy content. Cel = Fraction of exergy in the electricity, and/or mechanical energy, set to 100 % (Cel = 1). Ch = Carnot efficiency (fraction of exergy in the useful heat). The Carnot efficiency, Ch, for useful heat at different temperatures is defined as: where Th = Temperature, measured in absolute temperature (kelvin) of the useful heat at point of delivery. T0 = Temperature of surroundings, set at 273,15 kelvin (equal to 0 °C) If the excess heat is exported for heating of buildings, at a temperature below 150 °C (423,15 kelvin), Ch can alternatively be defined as follows: Ch = Carnot efficiency in heat at 150 °C (423,15 kelvin), which is: 0,3546 For the purposes of that calculation, the following definitions apply: (a) ‘cogeneration’ means the simultaneous generation in one process of thermal energy and electricity and/or mechanical energy; (b) ‘useful heat’ means heat generated to satisfy an economical justifiable demand for heat, for heating and cooling purposes; (c) ‘economically justifiable demand’ means the demand that does not exceed the needs for heat or cooling and which would otherwise be satisfied at market conditions. 2. Greenhouse gas emissions from biofuels and bioliquids shall be expressed as follows: (a) greenhouse gas emissions from biofuels, E, shall be expressed in terms of grams of CO2 equivalent per MJ of fuel, g CO2eq/MJ. (b) greenhouse gas emissions from bioliquids, EC, in terms of grams of CO2 equivalent per MJ of final energy commodity (heat or electricity), g CO2eq/MJ. When heating and cooling are co-generated with electricity, emissions shall be allocated between heat and electricity (as under 1(b)), irrespective if the heat is used for actual heating purposes or for cooling (2). Where the greenhouse gas emissions from the extraction or cultivation of raw materials eec are expressed in unit g CO2eq/dry-ton of feedstock, the conversion to grams of CO2 equivalent per MJ of fuel, g CO2eq/MJ, shall be calculated as follows (3): where Emissions per dry-ton feedstock shall be calculated as follows: 3. Greenhouse gas emissions savings from biofuels and bioliquids shall be calculated as follows: (a) greenhouse gas emissions savings from biofuels: SAVING = (EF(t) – EB)/EF(t), where EB = total emissions from the biofuel; and EF(t) = total emissions from the fossil fuel comparator for transport (b) greenhouse gas emissions savings from heat and cooling, and electricity being generated from bioliquids: SAVING = (ECF(h&c,el) – ECB(h&c,el))/ECF(h&c,el), where ECB(h&c,el) = total emissions from the heat or electricity; and ECF(h&c,el) = total emissions from the fossil fuel comparator for useful heat or electricity. 4. The greenhouse gases taken into account for the purposes of point 1 shall be CO2, N2O and CH4. For the purposes of calculating CO2 equivalence, those gases shall be valued as follows: CO2 : 1 N2O : 298 CH4 : 25 5. Emissions from the extraction or cultivation of raw materials, eec, shall include emissions from the extraction or cultivation process itself; from the collection, drying and storage of raw materials; from waste and leakages; and from the production of chemicals or products used in extraction or cultivation. Capture of CO2 in the cultivation of raw materials shall be excluded. Estimates of emissions from agriculture biomass cultivation may be derived from the use of regional averages for cultivation emissions included in the reports referred to in Article 31(4) or the information on the disaggregated default values for cultivation emissions included in this Annex, as an alternative to using actual values. In the absence of relevant information in those reports it is allowed to calculate averages based on local farming practises based for instance on data of a group of farms, as an alternative to using actual values. 6. For the purposes of the calculation referred to in point 1(a), greenhouse gas emissions savings from improved agriculture management, esca, such as shifting to reduced or zero-tillage, improved crop/rotation, the use of cover crops, including crop residue management, and the use of organic soil improver (e.g. compost, manure fermentation digestate), shall be taken into account only if solid and verifiable evidence is provided that the soil carbon has increased or that it is reasonable to expect to have increased over the period in which the raw materials concerned were cultivated while taking into account the emissions where such practices lead to increased fertiliser and herbicide use (4). 7. Annualised emissions from carbon stock changes caused by land-use change, el, shall be calculated by dividing total emissions equally over 20 years. For the calculation of those emissions, the following rule shall be applied: el = (CSR – CSA) × 3,664 × 1/20 × 1/P – eB, (5) where el = annualised greenhouse gas emissions from carbon stock change due to land-use change (measured as mass (grams) of CO2-equivalent per unit of biofuel or bioliquid energy (megajoules)). ‘Cropland’ (6) and ‘perennial cropland’ (7) shall be regarded as one land use; CSR = the carbon stock per unit area associated with the reference land-use (measured as mass (tonnes) of carbon per unit area, including both soil and vegetation). The reference land-use shall be the land-use in January 2008 or 20 years before the raw material was obtained, whichever was the later; CSA = the carbon stock per unit area associated with the actual land-use (measured as mass (tonnes) of carbon per unit area, including both soil and vegetation). In cases where the carbon stock accumulates over more than one year, the value attributed to CSA shall be the estimated stock per unit area after 20 years or when the crop reaches maturity, whichever the earlier; P = the productivity of the crop (measured as biofuel or bioliquid energy per unit area per year) and eB = bonus of 29 g CO2eq/MJ biofuel or bioliquid if biomass is obtained from restored degraded land under the conditions laid down in point 8. 8. The bonus of 29 g CO2eq/MJ shall be attributed if evidence is provided that the land: (a) was not in use for agriculture or any other activity in January 2008; and (b) is severely degraded land, including such land that was formerly in agricultural use. The bonus of 29 g CO2eq/MJ shall apply for a period of up to 20 years from the date of conversion of the land to agricultural use, provided that a steady increase in carbon stocks as well as a sizable reduction in erosion phenomena for land falling under (b) are ensured. 9. ‘Severely degraded land’ means land that, for a significant period of time, has either been significantly salinated or presented significantly low organic matter content and has been severely eroded. 10. The Commission shall review, by 31 December 2020, guidelines for the calculation of land carbon stocks (8) drawing on the 2006 IPCC Guidelines for National Greenhouse Gas Inventories – volume 4 and in accordance with Regulation (EU) No 525/2013 and Regulation (EU) 2018/841 of the European Parliament and of the Council (9). The Commission guidelines shall serve as the basis for the calculation of land carbon stocks for the purposes of this Directive. 11. Emissions from processing, ep, shall include emissions from the processing itself; from waste and leakages; and from the production of chemicals or products used in processing including the CO2 emissions corresponding to the carbon contents of fossil inputs, whether or not actually combusted in the process. In accounting for the consumption of electricity not produced within the fuel production plant, the greenhouse gas emissions intensity of the production and distribution of that electricity shall be assumed to be equal to the average emission intensity of the production and distribution of electricity in a defined region. By way of derogation from this rule, producers may use an average value for an individual electricity production plant for electricity produced by that plant, if that plant is not connected to the electricity grid. Emissions from processing shall include emissions from drying of interim products and materials where relevant. 12. Emissions from transport and distribution, etd, shall include emissions from the transport of raw and semi-finished materials and from the storage and distribution of finished materials. Emissions from transport and distribution to be taken into account under point 5 shall not be covered by this point. 13. Emissions of the fuel in use, eu, shall be taken to be zero for biofuels and bioliquids. Emissions of non-CO2 greenhouse gases (N2O and CH4) of the fuel in use shall be included in the eu factor for bioliquids. 14. Emission savings from CO2 capture and geological storage, eccs, that have not already been accounted for in ep, shall be limited to emissions avoided through the capture and storage of emitted CO2 directly related to the extraction, transport, processing and distribution of fuel if stored in compliance with Directive 2009/31/EC of the European Parliament and of the Council (10). 15. Emission savings from CO2 capture and replacement, eccr, shall be related directly to the production of biofuel or bioliquid they are attributed to, and shall be limited to emissions avoided through the capture of CO2 of which the carbon originates from biomass and which is used to replace fossil-derived CO2 in production of commercial products and services. 16. Where a cogeneration unit – providing heat and/or electricity to a fuel production process for which emissions are being calculated – produces excess electricity and/or excess useful heat, the greenhouse gas emissions shall be divided between the electricity and the useful heat according to the temperature of the heat (which reflects the usefulness (utility) of the heat). The useful part of the heat is found by multiplying its energy content with the Carnot efficiency, Ch, calculated as follows: where Th = Temperature, measured in absolute temperature (kelvin) of the useful heat at point of delivery. T0 = Temperature of surroundings, set at 273,15 kelvin (equal to 0 °C) If the excess heat is exported for heating of buildings, at a temperature below 150 °C (423,15 kelvin), Ch can alternatively be defined as follows: Ch = Carnot efficiency in heat at 150 °C (423,15 kelvin), which is: 0,3546 For the purposes of that calculation, the actual efficiencies shall be used, defined as the annual mechanical energy, electricity and heat produced respectively divided by the annual energy input. For the purposes of that calculation, the following definitions apply: (a) ‘cogeneration’ shall mean the simultaneous generation in one process of thermal energy and electrical and/or mechanical energy; (b) ‘useful heat’ shall mean heat generated to satisfy an economical justifiable demand for heat, for heating or cooling purposes; (c) ‘economically justifiable demand’ shall mean the demand that does not exceed the needs for heat or cooling and which would otherwise be satisfied at market conditions. 17. Where a fuel production process produces, in combination, the fuel for which emissions are being calculated and one or more other products (co-products), greenhouse gas emissions shall be divided between the fuel or its intermediate product and the co-products in proportion to their energy content (determined by lower heating value in the case of co-products other than electricity and heat). The greenhouse gas intensity of excess useful heat or excess electricity is the same as the greenhouse gas intensity of heat or electricity delivered to the fuel production process and is determined from calculating the greenhouse intensity of all inputs and emissions, including the feedstock and CH4 and N2O emissions, to and from the cogeneration unit, boiler or other apparatus delivering heat or electricity to the fuel production process. In the case of cogeneration of electricity and heat, the calculation is performed following point 16. 18. For the purposes of the calculation referred to in point 17, the emissions to be divided shall be eec + el + esca + those fractions of ep, etd, eccs, and eccr that take place up to and including the process step at which a co-product is produced. If any allocation to co-products has taken place at an earlier process step in the life-cycle, the fraction of those emissions assigned in the last such process step to the intermediate fuel product shall be used for those purposes instead of the total of those emissions. In the case of biofuels and bioliquids, all co-products shall be taken into account for the purposes of that calculation. No emissions shall be allocated to wastes and residues. Co-products that have a negative energy content shall be considered to have an energy content of zero for the purposes of the calculation. Wastes and residues, including tree tops and branches, straw, husks, cobs and nut shells, and residues from processing, including crude glycerine (glycerine that is not refined) and bagasse, shall be considered to have zero life-cycle greenhouse gas emissions up to the process of collection of those materials irrespectively of whether they are processed to interim products before being transformed into the final product. In the case of fuels produced in refineries, other than the combination of processing plants with boilers or cogeneration units providing heat and/or electricity to the processing plant, the unit of analysis for the purposes of the calculation referred to in point 17 shall be the refinery. 19. For biofuels, for the purposes of the calculation referred to in point 3, the fossil fuel comparator EF(t) shall be 94 g CO2eq/MJ. For bioliquids used for the production of electricity, for the purposes of the calculation referred to in point 3, the fossil fuel comparator ECF(e) shall be 183 g CO2eq/MJ. For bioliquids used for the production of useful heat, as well as for the production of heating and/or cooling, for the purposes of the calculation referred to in point 3, the fossil fuel comparator ECF(h&c) shall be 80 g CO2eq/MJ. D. DISAGGREGATED DEFAULT VALUES FOR BIOFUELS AND BIOLIQUIDS Disaggregated default values for cultivation: ‘eec’ as defined in Part C of this Annex, including soil N2O emissions Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) sugar beet ethanol 9,6 9,6 corn (maize) ethanol 25,5 25,5 other cereals excluding corn (maize) ethanol 27,0 27,0 sugar cane ethanol 17,1 17,1 the part from renewable sources of ETBE Equal to that of the ethanol production pathway used the part from renewable sources of TAEE Equal to that of the ethanol production pathway used rape seed biodiesel 32,0 32,0 sunflower biodiesel 26,1 26,1 soybean biodiesel 21,2 21,2 palm oil biodiesel 26,2 26,2 waste cooking oil biodiesel 0 0 animal fats from rendering biodiesel (**) 0 0 hydrotreated vegetable oil from rape seed 33,4 33,4 hydrotreated vegetable oil from sunflower 26,9 26,9 hydrotreated vegetable oil from soybean 22,1 22,1 hydrotreated vegetable oil from palm oil 27,4 27,4 hydrotreated oil from waste cooking oil 0 0 hydrotreated oil from animal fats from rendering (**) 0 0 pure vegetable oil from rape seed 33,4 33,4 pure vegetable oil from sunflower 27,2 27,2 pure vegetable oil from soybean 22,2 22,2 pure vegetable oil from palm oil 27,1 27,1 pure oil from waste cooking oil 0 0 Disaggregated default values for cultivation: ‘eec’ – for soil N2O emissions only (these are already included in the disaggregated values for cultivation emissions in the ‘eec’ table) Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) sugar beet ethanol 4,9 4,9 corn (maize) ethanol 13,7 13,7 other cereals excluding corn (maize) ethanol 14,1 14,1 sugar cane ethanol 2,1 2,1 the part from renewable sources of ETBE Equal to that of the ethanol production pathway used the part from renewable sources of TAEE Equal to that of the ethanol production pathway used rape seed biodiesel 17,6 17,6 sunflower biodiesel 12,2 12,2 soybean biodiesel 13,4 13,4 palm oil biodiesel 16,5 16,5 waste cooking oil biodiesel 0 0 animal fats from rendering biodiesel (**) 0 0 hydrotreated vegetable oil from rape seed 18,0 18,0 hydrotreated vegetable oil from sunflower 12,5 12,5 hydrotreated vegetable oil from soybean 13,7 13,7 hydrotreated vegetable oil from palm oil 16,9 16,9 hydrotreated oil from waste cooking oil 0 0 hydrotreated oil from animal fats from rendering (**) 0 0 pure vegetable oil from rape seed 17,6 17,6 pure vegetable oil from sunflower 12,2 12,2 pure vegetable oil from soybean 13,4 13,4 pure vegetable oil from palm oil 16,5 16,5 pure oil from waste cooking oil 0 0 Disaggregated default values for processing: ‘ep’ as defined in Part C of this Annex Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) sugar beet ethanol (no biogas from slop, natural gas as process fuel in conventional boiler) 18,8 26,3 sugar beet ethanol (with biogas from slop, natural gas as process fuel in conventional boiler) 9,7 13,6 sugar beet ethanol (no biogas from slop, natural gas as process fuel in CHP plant (*1)) 13,2 18,5 sugar beet ethanol (with biogas from slop, natural gas as process fuel in CHP plant (*1)) 7,6 10,6 sugar beet ethanol (no biogas from slop, lignite as process fuel in CHP plant (*1)) 27,4 38,3 sugar beet ethanol (with biogas from slop, lignite as process fuel in CHP plant (*1)) 15,7 22,0 corn (maize) ethanol (natural gas as process fuel in conventional boiler) 20,8 29,1 corn (maize) ethanol, (natural gas as process fuel in CHP plant (*1)) 14,8 20,8 corn (maize) ethanol (lignite as process fuel in CHP plant (*1)) 28,6 40,1 corn (maize) ethanol (forest residues as process fuel in CHP plant (*1)) 1,8 2,6 other cereals excluding maize ethanol (natural gas as process fuel in conventional boiler) 21,0 29,3 other cereals excluding maize ethanol (natural gas as process fuel in CHP plant (*1)) 15,1 21,1 other cereals excluding maize ethanol (lignite as process fuel in CHP plant (*1)) 30,3 42,5 other cereals excluding maize ethanol (forest residues as process fuel in CHP plant (*1)) 1,5 2,2 sugar cane ethanol 1,3 1,8 the part from renewable sources of ETBE Equal to that of the ethanol production pathway used the part from renewable sources of TAEE Equal to that of the ethanol production pathway used rape seed biodiesel 11,7 16,3 sunflower biodiesel 11,8 16,5 soybean biodiesel 12,1 16,9 palm oil biodiesel (open effluent pond) 30,4 42,6 palm oil biodiesel (process with methane capture at oil mill) 13,2 18,5 waste cooking oil biodiesel 9,3 13,0 animal fats from rendering biodiesel (*2) 13,6 19,1 hydrotreated vegetable oil from rape seed 10,7 15,0 hydrotreated vegetable oil from sunflower 10,5 14,7 hydrotreated vegetable oil from soybean 10,9 15,2 hydrotreated vegetable oil from palm oil (open effluent pond) 27,8 38,9 hydrotreated vegetable oil from palm oil (process with methane capture at oil mill) 9,7 13,6 hydrotreated oil from waste cooking oil 10,2 14,3 hydrotreated oil from animal fats from rendering (*2) 14,5 20,3 pure vegetable oil from rape seed 3,7 5.2 pure vegetable oil from sunflower 3,8 5,4 pure vegetable oil from soybean 4,2 5,9 pure vegetable oil from palm oil (open effluent pond) 22,6 31,7 pure vegetable oil from palm oil (process with methane capture at oil mill) 4,7 6,5 pure oil from waste cooking oil 0,6 0,8 Disaggregated default values for oil extraction only (these are already included in the disaggregated values for processing emissions in the ‘ep’ table) Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) rape seed biodiesel 3,0 4,2 sunflower biodiesel 2,9 4,0 soybean biodiesel 3,2 4,4 palm oil biodiesel (open effluent pond) 20,9 29,2 palm oil biodiesel (process with methane capture at oil mill) 3,7 5,1 waste cooking oil biodiesel 0 0 animal fats from rendering biodiesel (**) 4,3 6,1 hydrotreated vegetable oil from rape seed 3,1 4,4 hydrotreated vegetable oil from sunflower 3,0 4,1 hydrotreated vegetable oil from soybean 3,3 4,6 hydrotreated vegetable oil from palm oil (open effluent pond) 21,9 30,7 hydrotreated vegetable oil from palm oil (process with methane capture at oil mill) 3,8 5,4 hydrotreated oil from waste cooking oil 0 0 hydrotreated oil from animal fats from rendering (**) 4,3 6,0 pure vegetable oil from rape seed 3,1 4,4 pure vegetable oil from sunflower 3,0 4,2 pure vegetable oil from soybean 3,4 4,7 pure vegetable oil from palm oil (open effluent pond) 21,8 30,5 pure vegetable oil from palm oil (process with methane capture at oil mill) 3,8 5,3 pure oil from waste cooking oil 0 0 Disaggregated default values for transport and distribution: ‘etd’ as defined in Part C of this Annex Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) sugar beet ethanol (no biogas from slop, natural gas as process fuel in conventional boiler) 2,3 2,3 sugar beet ethanol (with biogas from slop, natural gas as process fuel in conventional boiler) 2,3 2,3 sugar beet ethanol (no biogas from slop, natural gas as process fuel in CHP plant (*3)) 2,3 2,3 sugar beet ethanol (with biogas from slop, natural gas as process fuel in CHP plant (*3)) 2,3 2,3 sugar beet ethanol (no biogas from slop, lignite as process fuel in CHP plant (*3)) 2,3 2,3 sugar beet ethanol (with biogas from slop, lignite as process fuel in CHP plant (*3)) 2,3 2,3 corn (maize) ethanol (natural gas as process fuel in CHP plant (*3)) 2,2 2,2 corn (maize) ethanol (natural gas as process fuel in conventional boiler) 2,2 2,2 corn (maize) ethanol (lignite as process fuel in CHP plant (*3)) 2,2 2,2 corn (maize) ethanol (forest residues as process fuel in CHP plant (*3)) 2,2 2,2 other cereals excluding maize ethanol (natural gas as process fuel in conventional boiler) 2,2 2,2 other cereals excluding maize ethanol (natural gas as process fuel in CHP plant (*3)) 2,2 2,2 other cereals excluding maize ethanol (lignite as process fuel in CHP plant (*3)) 2,2 2,2 other cereals excluding maize ethanol (forest residues as process fuel in CHP plant (*3)) 2,2 2,2 sugar cane ethanol 9,7 9,7 the part from renewable sources of ETBE Equal to that of the ethanol production pathway used the part from renewable sources of TAEE Equal to that of the ethanol production pathway used rape seed biodiesel 1,8 1,8 sunflower biodiesel 2,1 2,1 soybean biodiesel 8,9 8,9 palm oil biodiesel (open effluent pond) 6,9 6,9 palm oil biodiesel (process with methane capture at oil mill) 6,9 6,9 waste cooking oil biodiesel 1,9 1,9 animal fats from rendering biodiesel (*4) 1,7 1,7 hydrotreated vegetable oil from rape seed 1,7 1,7 hydrotreated vegetable oil from sunflower 2,0 2,0 hydrotreated vegetable oil from soybean 9,2 9,2 hydrotreated vegetable oil from palm oil (open effluent pond) 7,0 7,0 hydrotreated vegetable oil from palm oil (process with methane capture at oil mill) 7,0 7,0 hydrotreated oil from waste cooking oil 1,7 1,7 hydrotreated oil from animal fats from rendering (*4) 1,5 1,5 pure vegetable oil from rape seed 1,4 1,4 pure vegetable oil from sunflower 1,7 1,7 pure vegetable oil from soybean 8,8 8,8 pure vegetable oil from palm oil (open effluent pond) 6,7 6,7 pure vegetable oil from palm oil (process with methane capture at oil mill) 6,7 6,7 pure oil from waste cooking oil 1,4 1,4 Disaggregated default values for transport and distribution of final fuel only. These are already included in the table of ‘transport and distribution emissions etd’ as defined in Part C of this Annex, but the following values are useful if an economic operator wishes to declare actual transport emissions for crops or oil transport only). Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) sugar beet ethanol (no biogas from slop, natural gas as process fuel in conventional boiler) 1,6 1,6 sugar beet ethanol (with biogas from slop, natural gas as process fuel in conventional boiler) 1,6 1,6 sugar beet ethanol (no biogas from slop, natural gas as process fuel in CHP plant (*5)) 1,6 1,6 sugar beet ethanol (with biogas from slop, natural gas as process fuel in CHP plant (*5)) 1,6 1,6 sugar beet ethanol (no biogas from slop, lignite as process fuel in CHP plant (*5)) 1,6 1,6 sugar beet ethanol (with biogas from slop, lignite as process fuel in CHP plant (*5)) 1,6 1,6 corn (maize) ethanol (natural gas as process fuel in conventional boiler) 1,6 1,6 corn (maize) ethanol (natural gas as process fuel in CHP plant (*5)) 1,6 1,6 corn (maize) ethanol (lignite as process fuel in CHP plant (*5)) 1,6 1,6 corn (maize) ethanol (forest residues as process fuel in CHP plant (*5)) 1,6 1,6 other cereals excluding maize ethanol (natural gas as process fuel in conventional boiler) 1,6 1,6 other cereals excluding maize ethanol (natural gas as process fuel in CHP plant (*5)) 1,6 1,6 other cereals excluding maize ethanol (lignite as process fuel in CHP plant (*5)) 1,6 1,6 other cereals excluding maize ethanol (forest residues as process fuel in CHP plant (*5)) 1,6 1,6 sugar cane ethanol 6,0 6,0 the part of ethyl-tertio-butyl-ether (ETBE) from renewable ethanol Will be considered to be equal to that of the ethanol production pathway used the part of tertiary-amyl-ethyl-ether (TAEE) from renewable ethanol Will be considered to be equal to that of the ethanol production pathway used rape seed biodiesel 1,3 1,3 sunflower biodiesel 1,3 1,3 soybean biodiesel 1,3 1,3 palm oil biodiesel (open effluent pond) 1,3 1,3 palm oil biodiesel (process with methane capture at oil mill) 1,3 1,3 waste cooking oil biodiesel 1,3 1,3 animal fats from rendering biodiesel (*6) 1,3 1,3 hydrotreated vegetable oil from rape seed 1,2 1,2 hydrotreated vegetable oil from sunflower 1,2 1,2 hydrotreated vegetable oil from soybean 1,2 1,2 hydrotreated vegetable oil from palm oil (open effluent pond) 1,2 1,2 hydrotreated vegetable oil from palm oil (process with methane capture at oil mill) 1,2 1,2 hydrotreated oil from waste cooking oil 1,2 1,2 hydrotreated oil from animal fats from rendering (*6) 1,2 1,2 pure vegetable oil from rape seed 0,8 0,8 pure vegetable oil from sunflower 0,8 0,8 pure vegetable oil from soybean 0,8 0,8 pure vegetable oil from palm oil (open effluent pond) 0,8 0,8 pure vegetable oil from palm oil (process with methane capture at oil mill) 0,8 0,8 pure oil from waste cooking oil 0,8 0,8 Total for cultivation, processing, transport and distribution Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) sugar beet ethanol (no biogas from slop, natural gas as process fuel in conventional boiler) 30,7 38,2 sugar beet ethanol (with biogas from slop, natural gas as process fuel in conventional boiler) 21,6 25,5 sugar beet ethanol (no biogas from slop, natural gas as process fuel in CHP plant (*7)) 25,1 30,4 sugar beet ethanol (with biogas from slop, natural gas as process fuel in CHP plant (*7)) 19,5 22,5 sugar beet ethanol (no biogas from slop, lignite as process fuel in CHP plant (*7)) 39,3 50,2 sugar beet ethanol (with biogas from slop, lignite as process fuel in CHP plant (*7)) 27,6 33,9 corn (maize) ethanol (natural gas as process fuel in conventional boiler) 48,5 56,8 corn (maize) ethanol, (natural gas as process fuel in CHP plant (*7)) 42,5 48,5 corn (maize) ethanol (lignite as process fuel in CHP plant (*7)) 56,3 67,8 corn (maize) ethanol (forest residues as process fuel in CHP plant (*7)) 29,5 30,3 other cereals excluding maize ethanol (natural gas as process fuel in conventional boiler) 50,2 58,5 other cereals excluding maize ethanol (natural gas as process fuel in CHP plant (*7)) 44,3 50,3 other cereals excluding maize ethanol (lignite as process fuel in CHP plant (*7)) 59,5 71,7 other cereals excluding maize ethanol (forest residues as process fuel in CHP plant (*7)) 30,7 31.4 sugar cane ethanol 28,1 28.6 the part from renewable sources of ETBE Equal to that of the ethanol production pathway used the part from renewable sources of TAEE Equal to that of the ethanol production pathway used rape seed biodiesel 45,5 50,1 sunflower biodiesel 40,0 44,7 soybean biodiesel 42,2 47,0 palm oil biodiesel (open effluent pond) 63,5 75,7 palm oil biodiesel (process with methane capture at oil mill) 46,3 51,6 waste cooking oil biodiesel 11,2 14,9 animals fats from rendering biodiesel (*8) 15,3 20,8 hydrotreated vegetable oil from rape seed 45,8 50,1 hydrotreated vegetable oil from sunflower 39,4 43,6 hydrotreated vegetable oil from soybean 42,2 46,5 hydrotreated vegetable oil from palm oil (open effluent pond) 62,2 73,3 hydrotreated vegetable oil from palm oil (process with methane capture at oil mill) 44,1 48,0 hydrotreated oil from waste cooking oil 11,9 16,0 hydrotreated oil from animal fats from rendering (*8) 16,0 21,8 pure vegetable oil from rape seed 38,5 40,0 pure vegetable oil from sunflower 32,7 34,3 pure vegetable oil from soybean 35,2 36,9 pure vegetable oil from palm oil (open effluent pond) 56,3 65,4 pure vegetable oil from palm oil (process with methane capture at oil mill) 38,4 57,2 pure oil from waste cooking oil 2,0 2,2 E. ESTIMATED DISAGGREGATED DEFAULT VALUES FOR FUTURE BIOFUELS AND BIOLIQUIDS THAT WERE NOT ON THE MARKET OR WERE ONLY ON THE MARKET IN NEGLIGIBLE QUANTITIES IN 2016 Disaggregated default values for cultivation: ‘eec’ as defined in Part C of this Annex, including N2O emissions (including chipping of waste or farmed wood) Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) wheat straw ethanol 1,8 1,8 waste wood Fischer-Tropsch diesel in free-standing plant 3,3 3,3 farmed wood Fischer-Tropsch diesel in free-standing plant 8,2 8,2 waste wood Fischer-Tropsch petrol in free-standing plant 8,2 8,2 farmed wood Fischer-Tropsch petrol in free-standing plant 12,4 12,4 waste wood dimethylether (DME) in free-standing plant 3,1 3,1 farmed wood dimethylether (DME) in free-standing plant 7,6 7,6 waste wood methanol in free-standing plant 3,1 3,1 farmed wood methanol in free-standing plant 7,6 7,6 Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 2,5 2,5 Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 2,5 2,5 dimethylether (DME) from black-liquor gasification integrated with pulp mill 2,5 2,5 Methanol from black-liquor gasification integrated with pulp mill 2,5 2,5 the part from renewable sources of MTBE Equal to that of the methanol production pathway used Disaggregated default values for soil N2O emissions (included in disaggregated default values for cultivation emissions in the ‘eec’ table) Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) wheat straw ethanol 0 0 waste wood Fischer-Tropsch diesel in free-standing plant 0 0 farmed wood Fischer-Tropsch diesel in free-standing plant 4,4 4,4 waste wood Fischer-Tropsch petrol in free-standing plant 0 0 farmed wood Fischer-Tropsch petrol in free-standing plant 4,4 4,4 waste wood dimethylether (DME) in free-standing plant 0 0 farmed wood dimethylether (DME) in free-standing plant 4,1 4,1 waste wood methanol in free-standing plant 0 0 farmed wood methanol in free-standing plant 4,1 4,1 Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 0 0 Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 0 0 dimethylether (DME) from black-liquor gasification integrated with pulp mill 0 0 Methanol from black-liquor gasification integrated with pulp mill 0 0 the part from renewable sources of MTBE Equal to that of the methanol production pathway used Disaggregated default values for processing: ‘ep’ as defined in Part C of this Annex Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) wheat straw ethanol 4,8 6,8 waste wood Fischer-Tropsch diesel in free-standing plant 0,1 0,1 farmed wood Fischer-Tropsch diesel in free-standing plant 0,1 0,1 waste wood Fischer-Tropsch petrol in free-standing plant 0,1 0,1 farmed wood Fischer-Tropsch petrol in free-standing plant 0,1 0,1 waste wood dimethylether (DME) in free-standing plant 0 0 farmed wood dimethylether (DME) in free-standing plant 0 0 waste wood methanol in free-standing plant 0 0 farmed wood methanol in free-standing plant 0 0 Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 0 0 Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 0 0 dimethylether (DME) from black-liquor gasification integrated with pulp mill 0 0 methanol from black-liquor gasification integrated with pulp mill 0 0 the part from renewable sources of MTBE Equal to that of the methanol production pathway used Disaggregated default values for transport and distribution: ‘etd’ as defined in Part C of this Annex Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) wheat straw ethanol 7,1 7,1 waste wood Fischer-Tropsch diesel in free-standing plant 10,3 10,3 farmed wood Fischer-Tropsch diesel in free-standing plant 8,4 8,4 waste wood Fischer-Tropsch petrol in free-standing plant 10,3 10,3 farmed wood Fischer-Tropsch petrol in free-standing plant 8,4 8,4 waste wood dimethylether (DME) in free-standing plant 10,4 10,4 farmed wood dimethylether (DME) in free-standing plant 8,6 8,6 waste wood methanol in free-standing plant 10,4 10,4 farmed wood methanol in free-standing plant 8,6 8,6 Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 7,7 7,7 Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 7,9 7,9 dimethylether (DME) from black-liquor gasification integrated with pulp mill 7,7 7,7 methanol from black-liquor gasification integrated with pulp mill 7,9 7,9 the part from renewable sources of MTBE Equal to that of the methanol production pathway used Disaggregated default values for transport and distribution of final fuel only. These are already included in the table of ‘transport and distribution emissions etd’ as defined in Part C of this Annex, but the following values are useful if an economic operator wishes to declare actual transport emissions for feedstock transport only). Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) wheat straw ethanol 1,6 1,6 waste wood Fischer-Tropsch diesel in free-standing plant 1,2 1,2 farmed wood Fischer-Tropsch diesel in free-standing plant 1,2 1,2 waste wood Fischer-Tropsch petrol in free-standing plant 1,2 1,2 farmed wood Fischer-Tropsch petrol in free-standing plant 1,2 1,2 waste wood dimethylether (DME) in free-standing plant 2,0 2,0 farmed wood dimethylether (DME) in free-standing plant 2,0 2,0 waste wood methanol in free-standing plant 2,0 2,0 farmed wood methanol in free-standing plant 2,0 2,0 Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 2,0 2,0 Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 2,0 2,0 dimethylether (DME) from black-liquor gasification integrated with pulp mill 2,0 2,0 methanol from black-liquor gasification integrated with pulp mill 2,0 2,0 the part from renewable sources of MTBE Equal to that of the methanol production pathway used Total for cultivation, processing, transport and distribution Biofuel and bioliquid production pathway Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) wheat straw ethanol 13,7 15,7 waste wood Fischer-Tropsch diesel in free-standing plant 13,7 13,7 farmed wood Fischer-Tropsch diesel in free-standing plant 16,7 16,7 waste wood Fischer-Tropsch petrol in free-standing plant 13,7 13,7 farmed wood Fischer-Tropsch petrol in free-standing plant 16,7 16,7 waste wood dimethylether (DME) in free-standing plant 13,5 13,5 farmed wood dimethylether (DME) in free-standing plant 16,2 16,2 waste wood methanol in free-standing plant 13,5 13,5 farmed wood methanol in free-standing plant 16,2 16,2 Fischer-Tropsch diesel from black-liquor gasification integrated with pulp mill 10,2 10,2 Fischer-Tropsch petrol from black-liquor gasification integrated with pulp mill 10,4 10,4 dimethylether (DME) from black-liquor gasification integrated with pulp mill 10,2 10,2 methanol from black-liquor gasification integrated with pulp mill 10,4 10,4 the part from renewable sources of MTBE Equal to that of the methanol production pathway used (1) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1). (2) Heat or waste heat is used to generate cooling (chilled air or water) through absorption chillers . Therefore, it is appropriate to calculate only the emissions associated to the heat produced per MJ of heat, irrespectively if the end-use of the heat is actual heating or cooling via absorption chillers. (3) The formula for calculating greenhouse gas emissions from the extraction or cultivation of raw materials eec describes cases where feedstock is converted into biofuels in one step. For more complex supply chains, adjustments are needed for calculating greenhouse gas emissions from the extraction or cultivation of raw materials eec for intermediate products. (4) Measurements of soil carbon can constitute such evidence, e.g. by a first measurement in advance of the cultivation and subsequent ones at regular intervals several years apart. In such a case, before the second measurement is available, increase in soil carbon would be estimated on the basis of representative experiments or soil models. From the second measurement onwards, the measurements would constitute the basis for determining the existence of an increase in soil carbon and its magnitude. (5) The quotient obtained by dividing the molecular weight of CO2 (44,010 g/mol) by the molecular weight of carbon (12,011 g/mol) is equal to 3,664. (6) Cropland as defined by IPCC. (7) Perennial crops are defined as multi-annual crops, the stem of which is usually not annually harvested such as short rotation coppice and oil palm. (8) Commission Decision 2010/335/EU of 10 June 2010 on guidelines for the calculation of land carbon stocks for the purpose of Annex V to Directive 2009/28/EC (OJ L 151, 17.6.2010, p. 19). (9) Regulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (OJ L 156, 19.6.2018, p. 1). (10) Directive 2009/31/EC of the European Parliament and of the Council of 23 April 2009 on the geological storage of carbon dioxide and amending Council Directive 85/337/EEC, European Parliament and Council Directives 2000/60/EC, 2001/80/EC, 2004/35/EC, 2006/12/EC, 2008/1/EC and Regulation (EC) No 1013/2006 (OJ L 140, 5.6.2009, p. 114). (**) Applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. (**) Note: applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. (*1) Default values for processes using CHP are valid only if all the process heat is supplied by CHP. (*2) Note: applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. (**) Note: applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. (*3) Default values for processes using CHP are valid only if all the process heat is supplied by CHP. (*4) Note: applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. (*5) Default values for processes using CHP are valid only if all the process heat is supplied by CHP. (*6) Note: applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. (*7) Default values for processes using CHP are valid only if all the process heat is supplied by CHP. (*8) Note: applies only to biofuels produced from animal by-products classified as category 1 and 2 material in accordance with Regulation (EC) No 1069/2009, for which emissions related to hygenisation as part of the rendering are not considered. ANNEX VI RULES FOR CALCULATING THE GREENHOUSE GAS IMPACT OF BIOMASS FUELS AND THEIR FOSSIL FUEL COMPARATORS A. Typical and default values of greenhouse gas emissions savings for biomass fuels if produced with no net-carbon emissions from land-use change WOODCHIPS Biomass fuel production system Transport distance Greenhouse gas emissions savings –typical value Greenhouse gas emissions savings – default value Heat Electricity Heat Electricity Woodchips from forest residues 1 to 500 km 93 % 89 % 91 % 87 % 500 to 2 500 km 89 % 84 % 87 % 81 % 2 500 to 10 000 km 82 % 73 % 78 % 67 % Above 10 000 km 67 % 51 % 60 % 41 % Woodchips from short rotation coppice (Eucalyptus) 2 500 to 10 000 km 77 % 65 % 73 % 60 % Woodchips from short rotation coppice (Poplar – Fertilised) 1 to 500 km 89 % 83 % 87 % 81 % 500 to 2 500 km 85 % 78 % 84 % 76 % 2 500 to 10 000 km 78 % 67 % 74 % 62 % Above 10 000 km 63 % 45 % 57 % 35 % Woodchips from short rotation coppice (Poplar – No fertilisation) 1 to 500 km 91 % 87 % 90 % 85 % 500 to 2 500 km 88 % 82 % 86 % 79 % 2 500 to 10 000 km 80 % 70 % 77 % 65 % Above 10 000 km 65 % 48 % 59 % 39 % Woodchips from stemwood 1 to 500 km 93 % 89 % 92 % 88 % 500 to 2 500 km 90 % 85 % 88 % 82 % 2 500 to 10 000 km 82 % 73 % 79 % 68 % Above 10 000 km 67 % 51 % 61 % 42 % Woodchips from industry residues 1 to 500 km 94 % 92 % 93 % 90 % 500 to 2 500 km 91 % 87 % 90 % 85 % 2 500 to 10 000 km 83 % 75 % 80 % 71 % Above 10 000 km 69 % 54 % 63 % 44 % WOOD PELLETS (*1) Biomass fuel production system Transport distance Greenhouse gas emissions savings – typical value Greenhouse gas emissions savings – default value Heat Electricity Heat Electricity Wood briquettes or pellets from forest residues Case 1 1 to 500 km 58 % 37 % 49 % 24 % 500 to 2 500 km 58 % 37 % 49 % 25 % 2 500 to 10 000 km 55 % 34 % 47 % 21 % Above 10 000 km 50 % 26 % 40 % 11 % Case 2a 1 to 500 km 77 % 66 % 72 % 59 % 500 to 2 500 km 77 % 66 % 72 % 59 % 2 500 to 10 000 km 75 % 62 % 70 % 55 % Above 10 000 km 69 % 54 % 63 % 45 % Case 3a 1 to 500 km 92 % 88 % 90 % 85 % 500 to 2 500 km 92 % 88 % 90 % 86 % 2 500 to 10 000 km 90 % 85 % 88 % 81 % Above 10 000 km 84 % 76 % 81 % 72 % Wood briquettes or pellets from short rotation coppice (Eucalyptus) Case 1 2 500 to 10 000 km 52 % 28 % 43 % 15 % Case 2a 2 500 to 10 000 km 70 % 56 % 66 % 49 % Case 3a 2 500 to 10 000 km 85 % 78 % 83 % 75 % Wood briquettes or pellets from short rotation coppice (Poplar – Fertilised) Case 1 1 to 500 km 54 % 32 % 46 % 20 % 500 to 10 000 km 52 % 29 % 44 % 16 % Above 10 000 km 47 % 21 % 37 % 7 % Case 2a 1 to 500 km 73 % 60 % 69 % 54 % 500 to 10 000 km 71 % 57 % 67 % 50 % Above 10 000 km 66 % 49 % 60 % 41 % Case 3a 1 to 500 km 88 % 82 % 87 % 81 % 500 to 10 000 km 86 % 79 % 84 % 77 % Above 10 000 km 80 % 71 % 78 % 67 % Wood briquettes or pellets from short rotation coppice (Poplar – No fertilisation) Case 1 1 to 500 km 56 % 35 % 48 % 23 % 500 to 10 000 km 54 % 32 % 46 % 20 % Above 10 000 km 49 % 24 % 40 % 10 % Case 2a 1 to 500 km 76 % 64 % 72 % 58 % 500 to 10 000 km 74 % 61 % 69 % 54 % Above 10 000 km 68 % 53 % 63 % 45 % Case 3a 1 to 500 km 91 % 86 % 90 % 85 % 500 to 10 000 km 89 % 83 % 87 % 81 % Above 10 000 km 83 % 75 % 81 % 71 % Stemwood Case 1 1 to 500 km 57 % 37 % 49 % 24 % 500 to 2 500 km 58 % 37 % 49 % 25 % 2 500 to 10 000 km 55 % 34 % 47 % 21 % Above 10 000 km 50 % 26 % 40 % 11 % Case 2a 1 to 500 km 77 % 66 % 73 % 60 % 500 to 2 500 km 77 % 66 % 73 % 60 % 2 500 to 10 000 km 75 % 63 % 70 % 56 % Above 10 000 km 70 % 55 % 64 % 46 % Case 3a 1 to 500 km 92 % 88 % 91 % 86 % 500 to 2 500 km 92 % 88 % 91 % 87 % 2 500 to 10 000 km 90 % 85 % 88 % 83 % Above 10 000 km 84 % 77 % 82 % 73 % Wood briquettes or pellets from wood industry residues Case 1 1 to 500 km 75 % 62 % 69 % 55 % 500 to 2 500 km 75 % 62 % 70 % 55 % 2 500 to 10 000 km 72 % 59 % 67 % 51 % Above 10 000 km 67 % 51 % 61 % 42 % Case 2a 1 to 500 km 87 % 80 % 84 % 76 % 500 to 2 500 km 87 % 80 % 84 % 77 % 2 500 to 10 000 km 85 % 77 % 82 % 73 % Above 10 000 km 79 % 69 % 75 % 63 % Case 3a 1 to 500 km 95 % 93 % 94 % 91 % 500 to 2 500 km 95 % 93 % 94 % 92 % 2 500 to 10 000 km 93 % 90 % 92 % 88 % Above 10 000 km 88 % 82 % 85 % 78 % AGRICULTURE PATHWAYS Biomass fuel production system Transport distance Greenhouse gas emissions savings – typical value Greenhouse gas emissions savings – default value Heat Electricity Heat Electricity Agricultural Residues with density < 0,2 t/m3 (*2) 1 to 500 km 95 % 92 % 93 % 90 % 500 to 2 500 km 89 % 83 % 86 % 80 % 2 500 to 10 000 km 77 % 66 % 73 % 60 % Above 10 000 km 57 % 36 % 48 % 23 % Agricultural Residues with density > 0,2 t/m3 (*3) 1 to 500 km 95 % 92 % 93 % 90 % 500 to 2 500 km 93 % 89 % 92 % 87 % 2 500 to 10 000 km 88 % 82 % 85 % 78 % Above 10 000 km 78 % 68 % 74 % 61 % Straw pellets 1 to 500 km 88 % 82 % 85 % 78 % 500 to 10 000 km 86 % 79 % 83 % 74 % Above 10 000 km 80 % 70 % 76 % 64 % Bagasse briquettes 500 to 10 000 km 93 % 89 % 91 % 87 % Above 10 000 km 87 % 81 % 85 % 77 % Palm Kernel Meal Above 10 000 km 20 % -18 % 11 % -33 % Palm Kernel Meal (no CH4 emissions from oil mill) Above 10 000 km 46 % 20 % 42 % 14 % BIOGAS FOR ELECTRICITY (*4) Biogas production system Technological option Greenhouse gas emissions savings – typical value Greenhouse gas emissions savings – default value Wet manure (1) Case 1 Open digestate (2) 146 % 94 % Close digestate (3) 246 % 240 % Case 2 Open digestate 136 % 85 % Close digestate 227 % 219 % Case 3 Open digestate 142 % 86 % Close digestate 243 % 235 % Maize whole plant (4) Case 1 Open digestate 36 % 21 % Close digestate 59 % 53 % Case 2 Open digestate 34 % 18 % Close digestate 55 % 47 % Case 3 Open digestate 28 % 10 % Close digestate 52 % 43 % Biowaste Case 1 Open digestate 47 % 26 % Close digestate 84 % 78 % Case 2 Open digestate 43 % 21 % Close digestate 77 % 68 % Case 3 Open digestate 38 % 14 % Close digestate 76 % 66 % BIOGAS FOR ELECTRICITY – MIXTURES OF MANURE AND MAIZE Biogas production system Technological option Greenhouse gas emissions savings – typical value Greenhouse gas emissions savings – default value Manure – Maize 80 % - 20 % Case 1 Open digestate 72 % 45 % Close digestate 120 % 114 % Case 2 Open digestate 67 % 40 % Close digestate 111 % 103 % Case 3 Open digestate 65 % 35 % Close digestate 114 % 106 % Manure – Maize 70 % - 30 % Case 1 Open digestate 60 % 37 % Close digestate 100 % 94 % Case 2 Open digestate 57 % 32 % Close digestate 93 % 85 % Case 3 Open digestate 53 % 27 % Close digestate 94 % 85 % Manure – Maize 60 % - 40 % Case 1 Open digestate 53 % 32 % Close digestate 88 % 82 % Case 2 Open digestate 50 % 28 % Close digestate 82 % 73 % Case 3 Open digestate 46 % 22 % Close digestate 81 % 72 % BIOMETHANE FOR TRANSPORT (*5) Biomethane production system Technological options Greenhouse gas emissions savings – typical value Greenhouse gas emissions savings – default value Wet manure Open digestate, no off-gas combustion 117 % 72 % Open digestate, off-gas combustion 133 % 94 % Close digestate, no off-gas combustion 190 % 179 % Close digestate, off-gas combustion 206 % 202 % Maize whole plant Open digestate, no off-gas combustion 35 % 17 % Open digestate, off-gas combustion 51 % 39 % Close digestate, no off-gas combustion 52 % 41 % Close digestate, off-gas combustion 68 % 63 % Biowaste Open digestate, no off-gas combustion 43 % 20 % Open digestate, off-gas combustion 59 % 42 % Close digestate, no off-gas combustion 70 % 58 % Close digestate, off-gas combustion 86 % 80 % BIOMETHANE – MIXTURES OF MANURE AND MAIZE (*6) Biomethane production system Technological options Greenhouse gas emissions savings – typical value Greenhouse gas emissions savings – default value Manure – Maize 80 % - 20 % Open digestate, no off-gas combustion (5) 62 % 35 % Open digestate, off-gas combustion (6) 78 % 57 % Close digestate, no off-gas combustion 97 % 86 % Close digestate, off-gas combustion 113 % 108 % Manure – Maize 70 % - 30 % Open digestate, no off-gas combustion 53 % 29 % Open digestate, off-gas combustion 69 % 51 % Close digestate, no off-gas combustion 83 % 71 % Close digestate, off-gas combustion 99 % 94 % Manure – Maize 60 % - 40 % Open digestate, no off-gas combustion 48 % 25 % Open digestate, off-gas combustion 64 % 48 % Close digestate, no off-gas combustion 74 % 62 % Close digestate, off-gas combustion 90 % 84 % B. METHODOLOGY 1. Greenhouse gas emissions from the production and use of biomass fuels, shall be calculated as follows: (a) Greenhouse gas emissions from the production and use of biomass fuels before conversion into electricity, heating and cooling, shall be calculated as: E = eec + el + ep + etd + eu – esca – eccs – eccr, Where E = total emissions from the production of the fuel before energy conversion; eec = emissions from the extraction or cultivation of raw materials; el = annualised emissions from carbon stock changes caused by land-use change; ep = emissions from processing; etd = emissions from transport and distribution; eu = emissions from the fuel in use; esca = emission savings from soil carbon accumulation via improved agricultural management; eccs = emission savings from CO2 capture and geological storage; and eccr = emission savings from CO2 capture and replacement. Emissions from the manufacture of machinery and equipment shall not be taken into account. (b) In the case of co-digestion of different substrates in a biogas plant for the production of biogas or biomethane, the typical and default values of greenhouse gas emissions shall be calculated as: where E = greenhouse gas emissions per MJ biogas or biomethane produced from co-digestion of the defined mixture of substrates Sn = Share of feedstock n in energy content En = Emission in g CO2/MJ for pathway n as provided in Part D of this Annex (*) where Pn = energy yield [MJ] per kilogram of wet input of feedstock n (**) Wn = weighting factor of substrate n defined as: where: In = Annual input to digester of substrate n [tonne of fresh matter] AMn = Average annual moisture of substrate n [kg water/kg fresh matter] SMn = Standard moisture for substrate n (***). (*) For animal manure used as substrate, a bonus of 45 g CO2eq/MJ manure (– 54 kg CO2eq/t fresh matter) is added for improved agricultural and manure management. (**) The following values of Pn shall be used for calculating typical and default values: P(Maize): 4,16 [MJbiogas/kg wet maize @ 65 % moisture] P(Manure): 0,50 [MJbiogas/kg wet manure @ 90 % moisture] P(Biowaste) 3,41 [MJbiogas/kg wet biowaste @ 76 % moisture] (***) The following values of the standard moisture for substrate SMn shall be used: SM(Maize): 0,65 [kg water/kg fresh matter] SM(Manure): 0,90 [kg water/kg fresh matter] SM(Biowaste): 0,76 [kg water/kg fresh matter] (c) In the case of co-digestion of n substrates in a biogas plant for the production of electricity or biomethane, actual greenhouse gas emissions of biogas and biomethane are calculated as follows: where E = total emissions from the production of the biogas or biomethane before energy conversion; Sn = Share of feedstock n, in fraction of input to the digester; eec,n = emissions from the extraction or cultivation of feedstock n; etd,feedstock,n = emissions from transport of feedstock n to the digester; el,n = annualised emissions from carbon stock changes caused by land-use change, for feedstock n; esca = emission savings from improved agricultural management of feedstock n (*); ep = emissions from processing; etd,product = emissions from transport and distribution of biogas and/or biomethane; eu = emissions from the fuel in use, that is greenhouse gases emitted during combustion; eccs = emission savings from CO2 capture and geological storage; and eccr = emission savings from CO2 capture and replacement. (*) For esca a bonus of 45 g CO2eq/MJ manure shall be attributed for improved agricultural and manure management in the case animal manure is used as a substrate for the production of biogas and biomethane. (d) Greenhouse gas emissions from the use of biomass fuels in producing electricity, heating and cooling, including the energy conversion to electricity and/or heat or cooling produced, shall be calculated as follows: (i) For energy installations delivering only heat: (ii) For energy installations delivering only electricity: where ECh,el = Total greenhouse gas emissions from the final energy commodity. E = Total greenhouse gas emissions of the fuel before end-conversion. ηel = The electrical efficiency, defined as the annual electricity produced divided by the annual fuel input, based on its energy content. ηh = The heat efficiency, defined as the annual useful heat output divided by the annual fuel input, based on its energy content. (iii) For the electricity or mechanical energy coming from energy installations delivering useful heat together with electricity and/or mechanical energy: (iv) For the useful heat coming from energy installations delivering heat together with electricity and/or mechanical energy: where: ECh,el = Total greenhouse gas emissions from the final energy commodity. E = Total greenhouse gas emissions of the fuel before end-conversion. ηel = The electrical efficiency, defined as the annual electricity produced divided by the annual energy input, based on its energy content. ηh = The heat efficiency, defined as the annual useful heat output divided by the annual energy input, based on its energy content. Cel = Fraction of exergy in the electricity, and/or mechanical energy, set to 100 % (Cel = 1). Ch = Carnot efficiency (fraction of exergy in the useful heat). The Carnot efficiency, Ch, for useful heat at different temperatures is defined as: where: Th = Temperature, measured in absolute temperature (kelvin) of the useful heat at point of delivery. T0 = Temperature of surroundings, set at 273,15 kelvin (equal to 0 °C). If the excess heat is exported for heating of buildings, at a temperature below 150 °C (423,15 kelvin), Ch can alternatively be defined as follows: Ch = Carnot efficiency in heat at 150 °C (423,15 kelvin), which is: 0,3546 For the purposes of that calculation, the following definitions apply: (i) ‘cogeneration’ shall mean the simultaneous generation in one process of thermal energy and electricity and/or mechanical energy; (ii) ‘useful heat’ shall mean heat generated to satisfy an economical justifiable demand for heat, for heating or cooling purposes; (iii) ‘economically justifiable demand’ shall mean the demand that does not exceed the needs for heat or cooling and which would otherwise be satisfied at market conditions. 2. Greenhouse gas emissions from biomass fuels shall be expressed as follows: (a) greenhouse gas emissions from biomass fuels, E, shall be expressed in terms of grams of CO2 equivalent per MJ of biomass fuel, g CO2eq/MJ; (b) greenhouse gas emissions from heating or electricity, produced from biomass fuels, EC, shall be expressed in terms of grams of CO2 equivalent per MJ of final energy commodity (heat or electricity), g CO2eq/MJ. When heating and cooling are co-generated with electricity, emissions shall be allocated between heat and electricity (as under point 1(d)), irrespective if the heat is used for actual heating purposes or for cooling. (7) Where the greenhouse gas emissions from the extraction or cultivation of raw materials eec are expressed in unit g CO2eq/dry-ton of feedstock, the conversion to grams of CO2 equivalent per MJ of fuel, g CO2eq /MJ, shall be calculated as follows (8): Where Emissions per dry-ton feedstock shall be calculated as follows: 3. Greenhouse gas emissions savings from biomass fuels shall be calculated as follows: (a) greenhouse gas emissions savings from biomass fuels used as transport fuels: SAVING = (EF(t) – EB)/EF(t) where EB = total emissions from biomass fuels used as transport fuels; and EF(t) = total emissions from the fossil fuel comparator for transport (b) greenhouse gas emissions savings from heat and cooling, and electricity being generated from biomass fuels: SAVING = (ECF(h&c,el) – ECB(h&c,el))/ECF (h&c,el), where ECB(h&c,el) = total emissions from the heat or electricity, ECF(h&c,el) = total emissions from the fossil fuel comparator for useful heat or electricity. 4. The greenhouse gases taken into account for the purposes of point 1 shall be CO2, N2O and CH4. For the purposes of calculating CO2 equivalence, those gases shall be valued as follows: CO2: 1 N2O: 298 CH4: 25 5. Emissions from the extraction, harvesting or cultivation of raw materials, eec, shall include emissions from the extraction, harvesting or cultivation process itself; from the collection, drying and storage of raw materials; from waste and leakages; and from the production of chemicals or products used in extraction or cultivation. Capture of CO2 in the cultivation of raw materials shall be excluded. Estimates of emissions from agriculture biomass cultivation may be derived from the regional averages for cultivation emissions included in the reports referred to in Article 31(4) of this Directive or the information on the disaggregated default values for cultivation emissions included in this Annex, as an alternative to using actual values. In the absence of relevant information in those reports it is allowed to calculate averages based on local farming practises based for instance on data of a group of farms, as an alternative to using actual values. Estimates of emissions from cultivation and harvesting of forestry biomass may be derived from the use of averages for cultivation and harvesting emissions calculated for geographical areas at national level, as an alternative to using actual values. 6. For the purposes of the calculation referred to in point 1(a), emission savings from improved agriculture management, esca, such as shifting to reduced or zero-tillage, improved crop/rotation, the use of cover crops, including crop residue management, and the use of organic soil improver (e.g. compost, manure fermentation digestate), shall be taken into account only if solid and verifiable evidence is provided that the soil carbon has increased or that it is reasonable to expect to have increased over the period in which the raw materials concerned were cultivated while taking into account the emissions where such practices lead to increased fertiliser and herbicide use (9). 7. Annualised emissions from carbon stock changes caused by land-use change, el, shall be calculated by dividing total emissions equally over 20 years. For the calculation of those emissions the following rule shall be applied: el = (CSR – CSA) × 3,664 × 1/20 × 1/P – eB, (10) where el = annualised greenhouse gas emissions from carbon stock change due to land-use change (measured as mass of CO2-equivalent per unit biomass fuel energy). ‘Cropland’ (11) and ‘perennial cropland’ (12) shall be regarded as one land use; CSR = the carbon stock per unit area associated with the reference land use (measured as mass (tonnes) of carbon per unit area, including both soil and vegetation). The reference land use shall be the land use in January 2008 or 20 years before the raw material was obtained, whichever was the later; CSA = the carbon stock per unit area associated with the actual land use (measured as mass (tonnes) of carbon per unit area, including both soil and vegetation). In cases where the carbon stock accumulates over more than one year, the value attributed to CSA shall be the estimated stock per unit area after 20 years or when the crop reaches maturity, whichever the earlier; P = the productivity of the crop (measured as biomass fuel energy per unit area per year); and eB = bonus of 29 g CO2eq/MJ biomass fuel if biomass is obtained from restored degraded land under the conditions laid down in point 8. 8. The bonus of 29 g CO2eq/MJ shall be attributed if evidence is provided that the land: (a) was not in use for agriculture in January 2008 or any other activity; and (b) is severely degraded land, including such land that was formerly in agricultural use. The bonus of 29 g CO2eq/MJ shall apply for a period of up to 20 years from the date of conversion of the land to agricultural use, provided that a steady increase in carbon stocks as well as a sizable reduction in erosion phenomena for land falling under (b) are ensured. 9. ‘Severely degraded land’ means land that, for a significant period of time, has either been significantly salinated or presented significantly low organic matter content and has been severely eroded. 10. In accordance with point 10 of Part C of Annex V to this Directive, Commission Decision 2010/335/EU (13), which provides for guidelines for the calculation of land carbon stocks in relation to this Directive, drawing on the 2006 IPCC Guidelines for National Greenhouse Gas Inventories – volume 4, and in accordance with Regulations (EU) No 525/2013 and (EU) 2018/841, shall serve as the basis for the calculation of land carbon stocks. 11. Emissions from processing, ep, shall include emissions from the processing itself; from waste and leakages; and from the production of chemicals or products used in processing, including the CO2 emissions corresponding to the carbon contents of fossil inputs, whether or not actually combusted in the process. In accounting for the consumption of electricity not produced within the solid or gaseous biomass fuel production plant, the greenhouse gas emissions intensity of the production and distribution of that electricity shall be assumed to be equal to the average emission intensity of the production and distribution of electricity in a defined region. By way of derogation from this rule, producers may use an average value for an individual electricity production plant for electricity produced by that plant, if that plant is not connected to the electricity grid. Emissions from processing shall include emissions from drying of interim products and materials where relevant. 12. Emissions from transport and distribution, etd, shall include emissions from the transport of raw and semi-finished materials and from the storage and distribution of finished materials. Emissions from transport and distribution to be taken into account under point 5 shall not be covered by this point. 13. Emissions of CO2 from fuel in use, eu, shall be taken to be zero for biomass fuels. Emissions of non-CO2 greenhouse gases (CH4 and N2O) from the fuel in use shall be included in the eu factor. 14. Emission savings from CO2 capture and geological storage, eccs, that have not already been accounted for in ep, shall be limited to emissions avoided through the capture and storage of emitted CO2 directly related to the extraction, transport, processing and distribution of biomass fuel if stored in compliance with Directive 2009/31/EC. 15. Emission savings from CO2 capture and replacement, eccr, shall be related directly to the production of biomass fuel they are attributed to, and shall be limited to emissions avoided through the capture of CO2 of which the carbon originates from biomass and which is used to replace fossil-derived CO2 in production of commercial products and services. 16. Where a cogeneration unit – providing heat and/or electricity to a biomass fuel production process for which emissions are being calculated – produces excess electricity and/or excess useful heat, the greenhouse gas emissions shall be divided between the electricity and the useful heat according to the temperature of the heat (which reflects the usefulness (utility) of the heat). The useful part of the heat is found by multiplying its energy content with the Carnot efficiency, Ch, calculated as follows: where Th = Temperature, measured in absolute temperature (kelvin) of the useful heat at point of delivery. T0 = Temperature of surroundings, set at 273,15 kelvin (equal to 0 °C). If the excess heat is exported for heating of buildings, at a temperature below 150 °C (423,15 kelvin), Ch can alternatively be defined as follows: Ch = Carnot efficiency in heat at 150 °C (423,15 kelvin), which is: 0,3546 For the purposes of that calculation, the actual efficiencies shall be used, defined as the annual mechanical energy, electricity and heat produced respectively divided by the annual energy input. For the purposes of that calculation, the following definitions apply: (a) ‘cogeneration’ shall mean the simultaneous generation in one process of thermal energy and electrical and/or mechanical energy; (b) ‘useful heat’ shall mean heat generated to satisfy an economical justifiable demand for heat, for heating or cooling purposes; (c) ‘economically justifiable demand’ shall mean the demand that does not exceed the needs for heat or cooling and which would otherwise be satisfied at market conditions. 17. Where a biomass fuel production process produces, in combination, the fuel for which emissions are being calculated and one or more other products (‘co-products’), greenhouse gas emissions shall be divided between the fuel or its intermediate product and the co-products in proportion to their energy content (determined by lower heating value in the case of co-products other than electricity and heat). The greenhouse gas intensity of excess useful heat or excess electricity is the same as the greenhouse gas intensity of heat or electricity delivered to the biomass fuel production process and is determined from calculating the greenhouse gas intensity of all inputs and emissions, including the feedstock and CH4 and N2O emissions, to and from the cogeneration unit, boiler or other apparatus delivering heat or electricity to the biomass fuel production process. In the case of cogeneration of electricity and heat, the calculation is performed following point 16. 18. For the purposes of the calculations referred to in point 17, the emissions to be divided shall be eec + el + esca + those fractions of ep, etd, eccs and eccr that take place up to and including the process step at which a co-product is produced. If any allocation to co-products has taken place at an earlier process step in the life-cycle, the fraction of those emissions assigned in the last such process step to the intermediate fuel product shall be used for those purposes instead of the total of those emissions. In the case of biogas and biomethane, all co-products that do not fall under the scope of point 7 shall be taken into account for the purposes of that calculation. No emissions shall be allocated to wastes and residues. Co-products that have a negative energy content shall be considered to have an energy content of zero for the purposes of the calculation. Wastes and residues, including tree tops and branches, straw, husks, cobs and nut shells, and residues from processing, including crude glycerine (glycerine that is not refined) and bagasse, shall be considered to have zero life-cycle greenhouse gas emissions up to the process of collection of those materials irrespectively of whether they are processed to interim products before being transformed into the final product. In the case of biomass fuels produced in refineries, other than the combination of processing plants with boilers or cogeneration units providing heat and/or electricity to the processing plant, the unit of analysis for the purposes of the calculation referred to in point 17 shall be the refinery. 19. For biomass fuels used for the production of electricity, for the purposes of the calculation referred to in point 3, the fossil fuel comparator ECF(el) shall be 183 g CO2eq/MJ electricity or 212 g CO2eq/MJ electricity for the outermost regions. For biomass fuels used for the production of useful heat, as well as for the production of heating and/or cooling, for the purposes of the calculation referred to in point 3, the fossil fuel comparator ECF(h) shall be 80 g CO2eq/MJ heat. For biomass fuels used for the production of useful heat, in which a direct physical substitution of coal can be demonstrated, for the purposes of the calculation referred to in point 3, the fossil fuel comparator ECF(h) shall be 124 g CO2eq/MJ heat. For biomass fuels used as transport fuels, for the purposes of the calculation referred to in point 3, the fossil fuel comparator EF(t) shall be 94 g CO2eq/MJ. C. DISAGGREGATED DEFAULT VALUES FOR BIOMASS FUELS Wood briquettes or pellets Biomass fuel production system Transport distance Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) Cultivation Processing Transport Non-CO2 emissions from the fuel in use Cultivation Processing Transport Non-CO2 emissions from the fuel in use Wood chips from forest residues 1 to 500 km 0,0 1,6 3,0 0,4 0,0 1,9 3,6 0,5 500 to 2 500 km 0,0 1,6 5,2 0,4 0,0 1,9 6,2 0,5 2 500 to 10 000 km 0,0 1,6 10,5 0,4 0,0 1,9 12,6 0,5 Above 10 000 km 0,0 1,6 20,5 0,4 0,0 1,9 24,6 0,5 Wood chips from SRC (Eucalyptus) 2 500 to 10 000 km 4,4 0,0 11,0 0,4 4,4 0,0 13,2 0,5 Wood chips from SRC (Poplar – fertilised) 1 to 500 km 3,9 0,0 3,5 0,4 3,9 0,0 4,2 0,5 500 to 2 500 km 3,9 0,0 5,6 0,4 3,9 0,0 6,8 0,5 2 500 to 10 000 km 3,9 0,0 11,0 0,4 3,9 0,0 13,2 0,5 Above 10 000 km 3,9 0,0 21,0 0,4 3,9 0,0 25,2 0,5 Wood chips from SRC (Poplar – Not fertilised) 1 to 500 km 2,2 0,0 3,5 0,4 2,2 0,0 4,2 0,5 500 to 2 500 km 2,2 0,0 5,6 0,4 2,2 0,0 6,8 0,5 2 500 to 10 000 km 2,2 0,0 11,0 0,4 2,2 0,0 13,2 0,5 Above 10 000 km 2,2 0,0 21,0 0,4 2,2 0,0 25,2 0,5 Wood chips from stemwood 1 to 500 km 1,1 0,3 3,0 0,4 1,1 0,4 3,6 0,5 500 to 2 500 km 1,1 0,3 5,2 0,4 1,1 0,4 6,2 0,5 2 500 to 10 000 km 1,1 0,3 10,5 0,4 1,1 0,4 12,6 0,5 Above 10 000 km 1,1 0,3 20,5 0,4 1,1 0,4 24,6 0,5 Wood chips from wood industry residues 1 to 500 km 0,0 0,3 3,0 0,4 0,0 0,4 3,6 0,5 500 to 2 500 km 0,0 0,3 5,2 0,4 0,0 0,4 6,2 0,5 2 500 to 10 000 km 0,0 0,3 10,5 0,4 0,0 0,4 12,6 0,5 Above 10 000 km 0,0 0,3 20,5 0,4 0,0 0,4 24,6 0,5 Wood briquettes or pellets Biomass fuel production system Transport distance Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) Cultivation Processing Transport & distribution Non-CO2 emissions from the fuel in use Cultivation Processing Transport & distribution Non-CO2 emissions from the fuel in use Wood briquettes or pellets from forest residues (case 1) 1 to 500 km 0,0 25,8 2,9 0,3 0,0 30,9 3,5 0,3 500 to 2 500 km 0,0 25,8 2,8 0,3 0,0 30,9 3,3 0,3 2 500 to 10 000 km 0,0 25,8 4,3 0,3 0,0 30,9 5,2 0,3 Above 10 000 km 0,0 25,8 7,9 0,3 0,0 30,9 9,5 0,3 Wood briquettes or pellets from forest residues (case 2a) 1 to 500 km 0,0 12,5 3,0 0,3 0,0 15,0 3,6 0,3 500 to 2 500 km 0,0 12,5 2,9 0,3 0,0 15,0 3,5 0,3 2 500 to 10 000 km 0,0 12,5 4,4 0,3 0,0 15,0 5,3 0,3 Above 10 000 km 0,0 12,5 8,1 0,3 0,0 15,0 9,8 0,3 Wood briquettes or pellets from forest residues (case 3a) 1 to 500 km 0,0 2,4 3,0 0,3 0,0 2,8 3,6 0,3 500 to 2 500 km 0,0 2,4 2,9 0,3 0,0 2,8 3,5 0,3 2 500 to 10 000 km 0,0 2,4 4,4 0,3 0,0 2,8 5,3 0,3 Above 10 000 km 0,0 2,4 8,2 0,3 0,0 2,8 9,8 0,3 Wood briquettes from short rotation coppice (Eucalyptus – case 1) 2 500 to 10 000 km 3,9 24,5 4,3 0,3 3,9 29,4 5,2 0,3 Wood briquettes from short rotation coppice (Eucalyptus – case 2a) 2 500 to 10 000 km 5,0 10,6 4,4 0,3 5,0 12,7 5,3 0,3 Wood briquettes from short rotation coppice (Eucalyptus – case 3a) 2 500 to 10 000 km 5,3 0,3 4,4 0,3 5,3 0,4 5,3 0,3 Wood briquettes from short rotation coppice (Poplar – Fertilised – case 1) 1 to 500 km 3,4 24,5 2,9 0,3 3,4 29,4 3,5 0,3 500 to 10 000 km 3,4 24,5 4,3 0,3 3,4 29,4 5,2 0,3 Above 10 000 km 3,4 24,5 7,9 0,3 3,4 29,4 9,5 0,3 Wood briquettes from short rotation coppice (Poplar – Fertilised – case 2a) 1 to 500 km 4,4 10,6 3,0 0,3 4,4 12,7 3,6 0,3 500 to 10 000 km 4,4 10,6 4,4 0,3 4,4 12,7 5,3 0,3 Above 10 000 km 4,4 10,6 8,1 0,3 4,4 12,7 9,8 0,3 Wood briquettes from short rotation coppice (Poplar – Fertilised – case 3a) 1 to 500 km 4,6 0,3 3,0 0,3 4,6 0,4 3,6 0,3 500 to 10 000 km 4,6 0,3 4,4 0,3 4,6 0,4 5,3 0,3 Above 10 000 km 4,6 0,3 8,2 0,3 4,6 0,4 9,8 0,3 Wood briquettes from short rotation coppice (Poplar – no fertilisation – case 1) 1 to 500 km 2,0 24,5 2,9 0,3 2,0 29,4 3,5 0,3 500 to 2 500 km 2,0 24,5 4,3 0,3 2,0 29,4 5,2 0,3 2 500 to 10 000 km 2,0 24,5 7,9 0,3 2,0 29,4 9,5 0,3 Wood briquettes from short rotation coppice (Poplar – no fertilisation – case 2a) 1 to 500 km 2,5 10,6 3,0 0,3 2,5 12,7 3,6 0,3 500 to 10 000 km 2,5 10,6 4,4 0,3 2,5 12,7 5,3 0,3 Above 10 000 km 2,5 10,6 8,1 0,3 2,5 12,7 9,8 0,3 Wood briquettes from short rotation coppice (Poplar – no fertilisation– case 3a) 1 to 500 km 2,6 0,3 3,0 0,3 2,6 0,4 3,6 0,3 500 to 10 000 km 2,6 0,3 4,4 0,3 2,6 0,4 5,3 0,3 Above 10 000 km 2,6 0,3 8,2 0,3 2,6 0,4 9,8 0,3 Wood briquettes or pellets from stemwood (case 1) 1 to 500 km 1,1 24,8 2,9 0,3 1,1 29,8 3,5 0,3 500 to 2 500 km 1,1 24,8 2,8 0,3 1,1 29,8 3,3 0,3 2 500 to 10 000 km 1,1 24,8 4,3 0,3 1,1 29,8 5,2 0,3 Above 10 000 km 1,1 24,8 7,9 0,3 1,1 29,8 9,5 0,3 Wood briquettes or pellets from stemwood (case 2a) 1 to 500 km 1,4 11,0 3,0 0,3 1,4 13,2 3,6 0,3 500 to 2 500 km 1,4 11,0 2,9 0,3 1,4 13,2 3,5 0,3 2 500 to 10 000 km 1,4 11,0 4,4 0,3 1,4 13,2 5,3 0,3 Above 10 000 km 1,4 11,0 8,1 0,3 1,4 13,2 9,8 0,3 Wood briquettes or pellets from stemwood (case 3a) 1 to 500 km 1,4 0,8 3,0 0,3 1,4 0,9 3,6 0,3 500 to 2 500 km 1,4 0,8 2,9 0,3 1,4 0,9 3,5 0,3 2 500 to 10 000 km 1,4 0,8 4,4 0,3 1,4 0,9 5,3 0,3 Above 10 000 km 1,4 0,8 8,2 0,3 1,4 0,9 9,8 0,3 Wood briquettes or pellets from wood industry residues (case 1) 1 to 500 km 0,0 14,3 2,8 0,3 0,0 17,2 3,3 0,3 500 to 2 500 km 0,0 14,3 2,7 0,3 0,0 17,2 3,2 0,3 2 500 to 10 000 km 0,0 14,3 4,2 0,3 0,0 17,2 5,0 0,3 Above 10 000 km 0,0 14,3 7,7 0,3 0,0 17,2 9,2 0,3 Wood briquettes or pellets from wood industry residues (case 2a) 1 to 500 km 0,0 6,0 2,8 0,3 0,0 7,2 3,4 0,3 500 to 2 500 km 0,0 6,0 2,7 0,3 0,0 7,2 3,3 0,3 2 500 to 10 000 km 0,0 6,0 4,2 0,3 0,0 7,2 5,1 0,3 Above 10 000 km 0,0 6,0 7,8 0,3 0,0 7,2 9,3 0,3 Wood briquettes or pellets from wood industry residues (case 3a) 1 to 500 km 0,0 0,2 2,8 0,3 0,0 0,3 3,4 0,3 500 to 2 500 km 0,0 0,2 2,7 0,3 0,0 0,3 3,3 0,3 2 500 to 10 000 km 0,0 0,2 4,2 0,3 0,0 0,3 5,1 0,3 Above 10 000 km 0,0 0,2 7,8 0,3 0,0 0,3 9,3 0,3 Agriculture pathways Biomass fuel production system Transport distance Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) Cultivation Processing Transport & distribution Non-CO2 emissions from the fuel in use Cultivation Processing Transport & distribution Non-CO2 emissions from the fuel in use Agricultural Residues with density < 0,2 t/m3 1 to 500 km 0,0 0,9 2,6 0,2 0,0 1,1 3,1 0,3 500 to 2 500 km 0,0 0,9 6,5 0,2 0,0 1,1 7,8 0,3 2 500 to 10 000 km 0,0 0,9 14,2 0,2 0,0 1,1 17,0 0,3 Above 10 000 km 0,0 0,9 28,3 0,2 0,0 1,1 34,0 0,3 Agricultural Residues with density > 0,2 t/m3 1 to 500 km 0,0 0,9 2,6 0,2 0,0 1,1 3,1 0,3 500 to 2 500 km 0,0 0,9 3,6 0,2 0,0 1,1 4,4 0,3 2 500 to 10 000 km 0,0 0,9 7,1 0,2 0,0 1,1 8,5 0,3 Above 10 000 km 0,0 0,9 13,6 0,2 0,0 1,1 16,3 0,3 Straw pellets 1 to 500 km 0,0 5,0 3,0 0,2 0,0 6,0 3,6 0,3 500 to 10 000 km 0,0 5,0 4,6 0,2 0,0 6,0 5,5 0,3 Above 10 000 km 0,0 5,0 8,3 0,2 0,0 6,0 10,0 0,3 Bagasse briquettes 500 to 10 000 km 0,0 0,3 4,3 0,4 0,0 0,4 5,2 0,5 Above 10 000 km 0,0 0,3 8,0 0,4 0,0 0,4 9,5 0,5 Palm Kernel Meal Above 10 000 km 21,6 21,1 11,2 0,2 21,6 25,4 13,5 0,3 Palm Kernel Meal (no CH4 emissions from oil mill) Above 10 000 km 21,6 3,5 11,2 0,2 21,6 4,2 13,5 0,3 Disaggregated default values for biogas for the production of electricity Biomass fuel production system Technology TYPICAL VALUE [g CO2eq/MJ] DEFAULT VALUE [g CO2eq/MJ] Cultivation Processing Non-CO2 emissions from the fuel in use Transport Manure credits Cultivation Processing Non-CO2 emissions from the fuel in use Transport Manure credits Wet manure (14) case 1 Open digestate 0,0 69,6 8,9 0,8 – 107,3 0,0 97,4 12,5 0,8 – 107,3 Close digestate 0,0 0,0 8,9 0,8 – 97,6 0,0 0,0 12,5 0,8 – 97,6 case 2 Open digestate 0,0 74,1 8,9 0,8 – 107,3 0,0 103,7 12,5 0,8 – 107,3 Close digestate 0,0 4,2 8,9 0,8 – 97,6 0,0 5,9 12,5 0,8 – 97,6 case 3 Open digestate 0,0 83,2 8,9 0,9 – 120,7 0,0 116,4 12,5 0,9 – 120,7 Close digestate 0,0 4,6 8,9 0,8 – 108,5 0,0 6,4 12,5 0,8 – 108,5 Maize whole plant (15) case 1 Open digestate 15,6 13,5 8,9 0,0 (16) — 15,6 18,9 12,5 0,0 — Close digestate 15,2 0,0 8,9 0,0 — 15,2 0,0 12,5 0,0 — case 2 Open digestate 15,6 18,8 8,9 0,0 — 15,6 26,3 12,5 0,0 — Close digestate 15,2 5,2 8,9 0,0 — 15,2 7,2 12,5 0,0 — case 3 Open digestate 17,5 21,0 8,9 0,0 — 17,5 29,3 12,5 0,0 — Close digestate 17,1 5,7 8,9 0,0 — 17,1 7,9 12,5 0,0 — Biowaste case 1 Open digestate 0,0 21,8 8,9 0,5 — 0,0 30,6 12,5 0,5 — Close digestate 0,0 0,0 8,9 0,5 — 0,0 0,0 12,5 0,5 — case 2 Open digestate 0,0 27,9 8,9 0,5 — 0,0 39,0 12,5 0,5 — Close digestate 0,0 5,9 8,9 0,5 — 0,0 8,3 12,5 0,5 — case 3 Open digestate 0,0 31,2 8,9 0,5 — 0,0 43,7 12,5 0,5 — Close digestate 0,0 6,5 8,9 0,5 — 0,0 9,1 12,5 0,5 — Disaggregated default values for biomethane Biomethane production system Technological option TYPICAL VALUE [g CO2eq/MJ] DEFAULT VALUE [g CO2eq/MJ] Cultivation Processing Upgrading Transport Compression at filling station Manure credits Cultivation Processing Upgrading Transport Compression at filling station Manure credits Wet manure Open digestate no off-gas combustion 0,0 84,2 19,5 1,0 3,3 – 124,4 0,0 117,9 27,3 1,0 4,6 – 124,4 off-gas combustion 0,0 84,2 4,5 1,0 3,3 – 124,4 0,0 117,9 6,3 1,0 4,6 – 124,4 Close digestate no off-gas combustion 0,0 3,2 19,5 0,9 3,3 – 111,9 0,0 4,4 27,3 0,9 4,6 – 111,9 off-gas combustion 0,0 3,2 4,5 0,9 3,3 – 111,9 0,0 4,4 6,3 0,9 4,6 – 111,9 Maize whole plant Open digestate no off-gas combustion 18,1 20,1 19,5 0,0 3,3 — 18,1 28,1 27,3 0,0 4,6 — off-gas combustion 18,1 20,1 4,5 0,0 3,3 — 18,1 28,1 6,3 0,0 4,6 — Close digestate no off-gas combustion 17,6 4,3 19,5 0,0 3,3 — 17,6 6,0 27,3 0,0 4,6 — off-gas combustion 17,6 4,3 4,5 0,0 3,3 — 17,6 6,0 6,3 0,0 4,6 — Biowaste Open digestate no off-gas combustion 0,0 30,6 19,5 0,6 3,3 — 0,0 42,8 27,3 0,6 4,6 — off-gas combustion 0,0 30,6 4,5 0,6 3,3 — 0,0 42,8 6,3 0,6 4,6 — Close digestate no off-gas combustion 0,0 5,1 19,5 0,5 3,3 — 0,0 7,2 27,3 0,5 4,6 — off-gas combustion 0,0 5,1 4,5 0,5 3,3 — 0,0 7,2 6,3 0,5 4,6 — D. TOTAL TYPICAL AND DEFAULT VALUES FOR BIOMASS FUEL PATHWAYS Biomass fuel production system Transport distance Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) Woodchips from forest residues 1 to 500 km 5 6 500 to 2 500 km 7 9 2 500 to 10 000 km 12 15 Above 10 000 km 22 27 Woodchips from short rotation coppice (Eucalyptus) 2 500 to 10 000 km 16 18 Woodchips from short rotation coppice (Poplar – Fertilised) 1 to 500 km 8 9 500 to 2 500 km 10 11 2 500 to 10 000 km 15 18 Above 10 000 km 25 30 Woodchips from short rotation coppice (Poplar – No fertilisation) 1 to 500 km 6 7 500 to 2 500 km 8 10 2 500 to 10 000 km 14 16 Above 10 000 km 24 28 Woodchips from stemwood 1 to 500 km 5 6 500 to 2 500 km 7 8 2 500 to 10 000 km 12 15 Above 10 000 km 22 27 Woodchips from industry residues 1 to 500 km 4 5 500 to 2 500 km 6 7 2 500 to 10 000 km 11 13 Above 10 000 km 21 25 Wood briquettes or pellets from forest residues (case 1) 1 to 500 km 29 35 500 to 2 500 km 29 35 2 500 to 10 000 km 30 36 Above 10 000 km 34 41 Wood briquettes or pellets from forest residues (case 2a) 1 to 500 km 16 19 500 to 2 500 km 16 19 2 500 to 10 000 km 17 21 Above 10 000 km 21 25 Wood briquettes or pellets from forest residues (case 3a) 1 to 500 km 6 7 500 to 2 500 km 6 7 2 500 to 10 000 km 7 8 Above 10 000 km 11 13 Wood briquettes or pellets from short rotation coppice (Eucalyptus – case 1) 2 500 to 10 000 km 33 39 Wood briquettes or pellets from short rotation coppice (Eucalyptus – case 2a) 2 500 to 10 000 km 20 23 Wood briquettes or pellets from short rotation coppice (Eucalyptus – case 3a) 2 500 to 10 000 km 10 11 Wood briquettes or pellets from short rotation coppice (Poplar – Fertilised – case 1) 1 to 500 km 31 37 500 to 10 000 km 32 38 Above 10 000 km 36 43 Wood briquettes or pellets from short rotation coppice (Poplar – Fertilised – case 2a) 1 to 500 km 18 21 500 to 10 000 km 20 23 Above 10 000 km 23 27 Wood briquettes or pellets from short rotation coppice (Poplar – Fertilised – case 3a) 1 to 500 km 8 9 500 to 10 000 km 10 11 Above 10 000 km 13 15 Wood briquettes or pellets from short rotation coppice (Poplar – no fertilisation – case 1) 1 to 500 km 30 35 500 to 10 000 km 31 37 Above 10 000 km 35 41 Wood briquettes or pellets from short rotation coppice (Poplar – no fertilisation – case 2a) 1 to 500 km 16 19 500 to 10 000 km 18 21 Above 10 000 km 21 25 Wood briquettes or pellets from short rotation coppice (Poplar – no fertilisation – case 3a) 1 to 500 km 6 7 500 to 10 000 km 8 9 Above 10 000 km 11 13 Wood briquettes or pellets from stemwood (case 1) 1 to 500 km 29 35 500 to 2 500 km 29 34 2 500 to 10 000 km 30 36 Above 10 000 km 34 41 Wood briquettes or pellets from stemwood (case 2a) 1 to 500 km 16 18 500 to 2 500 km 15 18 2 500 to 10 000 km 17 20 Above 10 000 km 21 25 Wood briquettes or pellets from stemwood (case 3a) 1 to 500 km 5 6 500 to 2 500 km 5 6 2 500 to 10 000 km 7 8 Above 10 000 km 11 12 Wood briquettes or pellets from wood industry residues (case 1) 1 to 500 km 17 21 500 to 2 500 km 17 21 2 500 to 10 000 km 19 23 Above 10 000 km 22 27 Wood briquettes or pellets from wood industry residues (case 2a) 1 to 500 km 9 11 500 to 2 500 km 9 11 2 500 to 10 000 km 10 13 Above 10 000 km 14 17 Wood briquettes or pellets from wood industry residues (case 3a) 1 to 500 km 3 4 500 to 2 500 km 3 4 2 500 to 10 000 5 6 Above 10 000 km 8 10 Case 1 refers to processes in which a Natural Gas boiler is used to provide the process heat to the pellet mill. Process electricity is purchased from the grid. Case 2a refers to processes in which a boiler fuelled with wood chips is used to provide the process heat to the pellet mill. Process electricity is purchased from the grid. Case 3a refers to processes in which a CHP, fuelled with wood chips, is used to provide heat and electricity to the pellet mill. Biomass fuel production system Transport distance Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) Agricultural Residues with density < 0,2 t/m3 (17) 1 to 500 km 4 4 500 to 2 500 km 8 9 2 500 to 10 000 km 15 18 Above 10 000 km 29 35 Agricultural Residues with density > 0,2 t/m3 (18) 1 to 500 km 4 4 500 to 2 500 km 5 6 2 500 to 10 000 km 8 10 Above 10 000 km 15 18 Straw pellets 1 to 500 km 8 10 500 to 10 000 km 10 12 Above 10 000 km 14 16 Bagasse briquettes 500 to 10 000 km 5 6 Above 10 000 km 9 10 Palm Kernel Meal Above 10 000 km 54 61 Palm Kernel Meal (no CH4 emissions from oil mill) Above 10 000 km 37 40 Typical and default values – biogas for electricity Biogas production system Technological option Typical value Default value Greenhouse gas emissions (g CO2eq/MJ) Greenhouse gas emissions (g CO2eq/MJ) Biogas for electricity from wet manure Case 1 Open digestate (19) – 28 3 Close digestate (20) – 88 – 84 Case 2 Open digestate – 23 10 Close digestate – 84 – 78 Case 3 Open digestate – 28 9 Close digestate – 94 – 89 Biogas for electricity from maize whole plant Case 1 Open digestate 38 47 Close digestate 24 28 Case 2 Open digestate 43 54 Close digestate 29 35 Case 3 Open digestate 47 59 Close digestate 32 38 Biogas for electricity from biowaste Case 1 Open digestate 31 44 Close digestate 9 13 Case 2 Open digestate 37 52 Close digestate 15 21 Case 3 Open digestate 41 57 Close digestate 16 22 Typical and default values for biomethane Biomethane production system Technological option Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) Biomethane from wet manure Open digestate, no off-gas combustion (21) – 20 22 Open digestate, off-gas combustion (22) – 35 1 Close digestate, no off-gas combustion – 88 – 79 Close digestate, off-gas combustion – 103 – 100 Biomethane from maize whole plant Open digestate, no off-gas combustion 58 73 Open digestate, off-gas combustion 43 52 Close digestate, no off-gas combustion 41 51 Close digestate, off-gas combustion 26 30 Biomethane from biowaste Open digestate, no off-gas combustion 51 71 Open digestate, off-gas combustion 36 50 Close digestate, no off-gas combustion 25 35 Close digestate, off-gas combustion 10 14 Typical and default values – biogas for electricity – mixtures of manure and maize: greenhouse gas emissions with shares given on a fresh mass basis Biogas production system Technological options Greenhouse gas emissions – typical value (g CO2eq/MJ) Greenhouse gas emissions – default value (g CO2eq/MJ) Manure – Maize 80 % - 20 % Case 1 Open digestate 17 33 Close digestate – 12 – 9 Case 2 Open digestate 22 40 Close digestate – 7 – 2 Case 3 Open digestate 23 43 Close digestate – 9 – 4 Manure – Maize 70 % - 30 % Case 1 Open digestate 24 37 Close digestate 0 3 Case 2 Open digestate 29 45 Close digestate 4 10 Case 3 Open digestate 31 48 Close digestate 4 10 Manure – Maize 60 % - 40 % Case 1 Open digestate 28 40 Close digestate 7 11 Case 2 Open digestate 33 47 Close digestate 12 18 Case 3 Open digestate 36 52 Close digestate 12 18 Comments Case 1 refers to pathways in which electricity and heat required in the process are supplied by the CHP engine itself. Case 2 refers to pathways in which the electricity required in the process is taken from the grid and the process heat is supplied by the CHP engine itself. In some Member States, operators are not allowed to claim the gross production for subsidies and case 1 is the more likely configuration. Case 3 refers to pathways in which the electricity required in the process is taken from the grid and the process heat is supplied by a biogas boiler. This case applies to some installations in which the CHP engine is not on-site and biogas is sold (but not upgraded to biomethane). Typical and default values – biomethane - mixtures of manure and maize: greenhouse gas emissions with shares given on a fresh mass basis Biomethane production system Technological options Typical value Default value (g CO2eq/MJ) (g CO2eq/MJ) Manure – Maize 80 % - 20 % Open digestate, no off-gas combustion 32 57 Open digestate, off-gas combustion 17 36 Close digestate, no off-gas combustion – 1 9 Close digestate, off-gas combustion – 16 – 12 Manure – Maize 70 % - 30 % Open digestate, no off-gas combustion 41 62 Open digestate, off-gas combustion 26 41 Close digestate, no off-gas combustion 13 22 Close digestate, off-gas combustion – 2 1 Manure – Maize 60 % - 40 % Open digestate, no off-gas combustion 46 66 Open digestate, off-gas combustion 31 45 Close digestate, no off-gas combustion 22 31 Close digestate, off-gas combustion 7 10 Where biomethane is used as Compressed Biomethane as a transport fuel, a value of 3,3 g CO2eq/MJ biomethane needs to be added to the typical values and a value of 4,6 g CO2eq/MJ biomethane to the default values. (*1) Case 1 refers to processes in which a natural gas boiler is used to provide the process heat to the pellet mill. Electricity for the pellet mill is supplied from the grid; Case 2a refers to processes in which a woodchips boiler, fed with pre-dried chips, is used to provide process heat. Electricity for the pellet mill is supplied from the grid; Case 3a refers to processes in which a CHP, fed with pre-dried woodchips, is used to provide electricity and heat to the pellet mill. (*2) This group of materials includes agricultural residues with a low bulk density and it comprises materials such as straw bales, oat hulls, rice husks and sugar cane bagasse bales (not exhaustive list). (*3) The group of agricultural residues with higher bulk density includes materials such as corn cobs, nut shells, soybean hulls, palm kernel shells (not exhaustive list). (*4) Case 1 refers to pathways in which electricity and heat required in the process are supplied by the CHP engine itself. Case 2 refers to pathways in which the electricity required in the process is taken from the grid and the process heat is supplied by the CHP engine itself. In some Member States, operators are not allowed to claim the gross production for subsidies and case 1 is the more likely configuration. Case 3 refers to pathways in which the electricity required in the process is taken from the grid and the process heat is supplied by a biogas boiler. This case applies to some installations in which the CHP engine is not on-site and biogas is sold (but not upgraded to biomethane). (1) The values for biogas production from manure include negative emissions for emissions saved from raw manure management. The value of esca considered is equal to – 45 g CO2eq/MJ manure used in anaerobic digestion. (2) Open storage of digestate accounts for additional emissions of CH4 and N2O. The magnitude of those emissions changes with ambient conditions, substrate types and the digestion efficiency. (3) Close storage means that the digestate resulting from the digestion process is stored in a gas-tight tank and that the additional biogas released during storage is considered to be recovered for production of additional electricity or biomethane. No greenhouse gas emissions are included in that process. (4) Maize whole plant means maize harvested as fodder and ensiled for preservation. (*5) The greenhouse gas emissions savings for biomethane only refer to compressed biomethane relative to the fossil fuel comparator for transport of 94 g CO2eq/MJ. (*6) The greenhouse gas emissions savings for biomethane only refer to compressed biomethane relative to the fossil fuel comparator for transport of 94 g CO2eq/MJ. (5) This category includes the following categories of technologies for biogas upgrade to biomethane: Pressure Swing Adsorption (PSA), Pressure Water Scrubbing (PWS), Membranes, Cryogenic, and Organic Physical Scrubbing (OPS). It includes an emission of 0,03 MJ CH4/MJ biomethane for the emission of methane in the off-gases. (6) This category includes the following categories of technologies for biogas upgrade to biomethane: Pressure Water Scrubbing (PWS) when water is recycled, Pressure Swing Adsorption (PSA), Chemical Scrubbing, Organic Physical Scrubbing (OPS), Membranes and Cryogenic upgrading. No methane emissions are considered for this category (the methane in the off-gas is combusted, if any). (7) Heat or waste heat is used to generate cooling (chilled air or water) through absorption chillers. Therefore, it is appropriate to calculate only the emissions associated to the heat produced, per MJ of heat, irrespectively if the end-use of the heat is actual heating or cooling via absorption chillers. (8) The formula for calculating greenhouse gas emissions from the extraction or cultivation of raw materials eec describes cases where feedstock is converted into biofuels in one step. For more complex supply chains, adjustments are needed for calculating greenhouse gas emissions from the extraction or cultivation of raw materials eec for intermediate products. (9) Measurements of soil carbon can constitute such evidence, e.g. by a first measurement in advance of the cultivation and subsequent ones at regular intervals several years apart. In such a case, before the second measurement is available, increase in soil carbon would be estimated on the basis of representative experiments or soil models. From the second measurement onwards, the measurements would constitute the basis for determining the existence of an increase in soil carbon and its magnitude. (10) The quotient obtained by dividing the molecular weight of CO2 (44,010 g/mol) by the molecular weight of carbon (12,011 g/mol) is equal to 3,664. (11) Cropland as defined by IPCC. (12) Perennial crops are defined as multi-annual crops, the stem of which is usually not annually harvested such as short rotation coppice and oil palm. (13) Commission Decision 2010/335/EU of 10 June 2010 on guidelines for the calculation of land carbon stocks for the purpose of Annex V to Directive 2009/28/EC (OJ L 151, 17.6.2010, p. 19). (14) The values for biogas production from manure include negative emissions for emissions saved from raw manure management. The value of esca considered is equal to – 45 g CO2eq/MJ manure used in anaerobic digestion. (15) Maize whole plant means maize harvested as fodder and ensiled for preservation. (16) Transport of agricultural raw materials to the transformation plant is, according to the methodology provided in the Commission's report of 25 February 2010 on sustainability requirements for the use of solid and gaseous biomass sources in electricity, heating and cooling, included in the ‘cultivation’ value. The value for transport of maize silage accounts for 0,4 g CO2eq/MJ biogas. (17) This group of materials includes agricultural residues with a low bulk density and it comprises materials such as straw bales, oat hulls, rice husks and sugar cane bagasse bales (not exhaustive list). (18) The group of agricultural residues with higher bulk density includes materials such as corn cobs, nut shells, soybean hulls, palm kernel shells (not exhaustive list). (19) Open storage of digestate accounts for additional emissions of methane which change with the weather, the substrate and the digestion efficiency. In these calculations the amounts are taken to be equal to 0,05 MJ CH4/MJ biogas for manure, 0,035 MJ CH4/MJ biogas for maize and 0,01 MJ CH4/MJ biogas for biowaste. (20) Close storage means that the digestate resulting from the digestion process is stored in a gas tight tank and the additional biogas released during storage is considered to be recovered for production of additional electricity or biomethane. (21) This category includes the following categories of technologies for biogas upgrade to biomethane: Pressure Swing Adsorption (PSA), Pressure Water Scrubbing (PWS), Membranes, Cryogenic, and Organic Physical Scrubbing (OPS). It includes an emission of 0,03 MJ CH4/MJ biomethane for the emission of methane in the off-gases. (22) This category includes the following categories of technologies for biogas upgrade to biomethane: Pressure Water Scrubbing (PWS) when water is recycled, Pressure Swing Adsorption (PSA), Chemical Scrubbing, Organic Physical Scrubbing (OPS), Membranes and Cryogenic upgrading. No methane emissions are considered for this category (the methane in the off-gas is combusted, if any). ANNEX VII ACCOUNTING OF ENERGY FROM HEAT PUMPS The amount of aerothermal, geothermal or hydrothermal energy captured by heat pumps to be considered to be energy from renewable sources for the purposes of this Directive, ERES, shall be calculated in accordance with the following formula: ERES = Qusable * (1 – 1/SPF) where — = Qusable = the estimated total usable heat delivered by heat pumps fulfilling the criteria referred to in Article 7(4), implemented as follows: Only heat pumps for which SPF > 1,15 * 1/η shall be taken into account, — = SPF = the estimated average seasonal performance factor for those heat pumps, — = η = the ratio between total gross production of electricity and the primary energy consumption for the production of electricity and shall be calculated as an EU average based on Eurostat data. ANNEX VIII PART A. PROVISIONAL ESTIMATED INDIRECT LAND-USE CHANGE EMISSIONS FROM BIOFUEL, BIOLIQUID AND BIOMASS FUEL FEEDSTOCK (g CO2eq/MJ) (1) Feedstock group Mean (2) Interpercentile range derived from the sensitivity analysis (3) Cereals and other starch-rich crops 12 8 to 16 Sugars 13 4 to 17 Oil crops 55 33 to 66 PART B. BIOFUELS, BIOLIQUIDS AND BIOMASS FUELS FOR WHICH THE ESTIMATED INDIRECT LAND-USE CHANGE EMISSIONS ARE CONSIDERED TO BE ZERO Biofuels, bioliquids and biomass fuels produced from the following feedstock categories will be considered to have estimated indirect land-use change emissions of zero: (1) feedstocks which are not listed under part A of this Annex. (2) feedstocks, the production of which has led to direct land-use change, namely, a change from one of the following IPCC land cover categories: forest land, grassland, wetlands, settlements, or other land, to cropland or perennial cropland (4). In such a case a direct land-use change emission value (el) should have been calculated in accordance with point 7 of part C of Annex V. (1) The mean values reported here represent a weighted average of the individually modelled feedstock values. The magnitude of the values in the Annex is sensitive to the range of assumptions (such as treatment of co-products, yield developments, carbon stocks and displacement of other commodities) used in the economic models developed for their estimation. Although it is therefore not possible to fully characterise the uncertainty range associated with such estimates, a sensitivity analysis conducted on the results based on a random variation of key parameters, a so-called Monte Carlo analysis, was conducted. (2) The mean values included here represent a weighted average of the individually modelled feedstock values. (3) The range included here reflects 90 % of the results using the fifth and ninety-fifth percentile values resulting from the analysis. The fifth percentile suggests a value below which 5 % of the observations were found (namely, 5 % of total data used showed results below 8, 4, and 33 g CO2eq/MJ). The ninety-fifth percentile suggests a value below which 95 % of the observations were found (namely, 5 % of total data used showed results above 16, 17, and 66 g CO2eq/MJ). (4) Perennial crops are defined as multi-annual crops, the stem of which is usually not annually harvested such as short rotation coppice and oil palm. ANNEX IX Part A. Feedstocks for the production of biogas for transport and advanced biofuels, the contribution of which towards the minimum shares referred to in the first and fourth subparagraphs of Article 25(1) may be considered to be twice their energy content: (a) Algae if cultivated on land in ponds or photobioreactors; (b) Biomass fraction of mixed municipal waste, but not separated household waste subject to recycling targets under point (a) of Article 11(2) of Directive 2008/98/EC; (c) Biowaste as defined in point (4) of Article 3 of Directive 2008/98/EC from private households subject to separate collection as defined in point (11) of Article 3 of that Directive; (d) Biomass fraction of industrial waste not fit for use in the food or feed chain, including material from retail and wholesale and the agro-food and fish and aquaculture industry, and excluding feedstocks listed in part B of this Annex; (e) Straw; (f) Animal manure and sewage sludge; (g) Palm oil mill effluent and empty palm fruit bunches; (h) Tall oil pitch; (i) Crude glycerine; (j) Bagasse; (k) Grape marcs and wine lees; (l) Nut shells; (m) Husks; (n) Cobs cleaned of kernels of corn; (o) Biomass fraction of wastes and residues from forestry and forest-based industries, namely, bark, branches, pre-commercial thinnings, leaves, needles, tree tops, saw dust, cutter shavings, black liquor, brown liquor, fibre sludge, lignin and tall oil; (p) Other non-food cellulosic material; (q) Other ligno-cellulosic material except saw logs and veneer logs. Part B. Feedstocks for the production of biofuels and biogas for transport, the contribution of which towards the minimum share established in the first subparagraph of Article 25(1) shall be limited and may be considered to be twice their energy content: (a) Used cooking oil; (b) Animal fats classified as categories 1 and 2 in accordance with Regulation (EC) No 1069/2009. ANNEX X PART A Repealed Directive with a list of the successive amendments thereto (referred to in Article 37) Directive 2009/28/EC of the European Parliament and of the Council (OJ L 140, 5.6.2009, p. 16) Council Directive 2013/18/EU (OJ L 158, 10.6.2013, p. 230) Directive (EU) 2015/1513 of the European Parliament and of the Council (OJ L 239, 15.9.2015, p. 1) Only Article 2 PART B Time-limits for transposition into national law (referred to in Article 36) Directive Time-limit for transposition 2009/28/EC 25 June 2009 2013/18/EU 1 July 2013 (EU) 2015/1513 10 September 2017 ANNEX XI Correlation table Directive 2009/28/EC This Directive Article 1 Article 1 Article 2, first subparagraph Article 2, first subparagraph Article 2, second subparagraph, introductory wording Article 2, second subparagraph, introductory wording Article 2, second subparagraph, point (a) Article 2, second subparagraph, point (1) Article 2, second subparagraph, point (b) — — Article 2, second subparagraph, point (2) Article 2, second subparagraph, point (c) Article 2, second subparagraph, point (3) Article 2, second subparagraph, point (d) — Article 2, second subparagraph, points (e), (f), (g), (h), (i), (j), (k), (l), (m), (n), (o), (p), (q), (r), (s), (t), (u), (v) and (w) Article 2, second subparagraph, points (24), (4), (19), (32), (33), (12), (5), (6), (45), (46), (47), (23), (39), (41), (42), (43), (36), (44) and (37) — Article 2, second subparagraph, points (7), (8), (9), (10), (11), (13), (14), (15), (16), (17), (18), (20), (21), (22), (25), (26), (27), (28), (29), (30), (31), (34), (35), (38) and (40) Article 3 — — Article 3 Article 4 — — Article 4 — Article 5 — Article 6 Article 5(1) Article 7(1) Article 5(2) — Article 5(3) Article 7(2) Article 5(4), first, second, third and fourth subparagraphs Article 7(3), first, second, third and fourth subparagraphs — Article 7(3), fifth and sixth subparagraphs — Article 7(4) Article 5(5), Article 27(1), first subparagraph, point (c) Article 5(6) and (7) Article 7(5) and (6) Article 6(1) Article 8(1) — Article 8(2) and (3) Article 6(2) and (3) Article 8(4) and (5) Article 7(1), (2), (3), (4) and (5) Article 9(1), (2), (3), (4) and (5) — Article 9(6) Article 8 Article 10 Article 9(1) Article 11(1) Article 9(2), first subparagraph, points (a), (b) and (c) Article 11(2), first subparagraph, points (a), (b) and (c) — Article 11(2), first subparagraph, point (d) Article 10 Article 12 Article 11(1), (2) and (3) Article 13(1), (2) and (3) — Article 13(4) Article 12 Article 14 Article 13(1), first subparagraph Article 15(1), first subparagraph Article 13(1), second subparagraph Article 15(1), second subparagraph Article 13(1), second subparagraph, points (a) and (b) — Article 13(1), second subparagraph, points (c), (d), (e) and (f) Article 15(1), second subparagraph, points (a), (b), (c) and (d) Article 13(2), (3), (4) and (5) Article 15(2), (3), (4) and (5) Article 13(6), first subparagraph Article 15(6), first subparagraph Article 13(6), second, third, fourth and fifth subparagraphs — — Article 15, (7) and (8) — Article 16 — Article 17 Article 14 Article 18 Article 15(1) Article 19(1) Article 15(2), first, second and third subparagraphs Article 19(2) first, second and third subparagraphs — Article 19(2), fourth and fifth subparagraphs Article 15(2), fourth subparagraph Article 19(2), sixth subparagraph Article 15(3) — — Article 19(3) and (4) Article 15(4) and (5) Article 19(5) and (6) Article 15(6), first subparagraph, point (a) Article 19(7), first subparagraph, point (a) Article 15(6), first subparagraph, point (b)(i) Article 19(7), first subparagraph, point (b)(i) — Article 19(7), first subparagraph, point (b)(ii) Article 15(6), first subparagraph, point (b)(ii) Article 19(7), first subparagraph, point (b)(iii) Article 15(6), first subparagraph, points (c), (d), (e) and (f) Article 19(7), first subparagraph, points (c), (d), (e) and (f) — Article 19(7), second subparagraph Article 15(7) Article 19(8) Article 15(8) — Article 15(9) and (10) Article 19(9) and (10) — Article 19(11) Article 15(11) Article 19(12) Article 15(12) — — Article 19(13) Article 16(1), (2), (3), (4), (5), (6), (7) and (8) — Article 16(9), (10) and (11) Article 20(1), (2) and (3) — Article 21 — Article 22 — Article 23 — Article 24 — Article 25 — Article 26 — Article 27 — Article 28 Article 17(1), first and second subparagraphs Article 29(1), first and second subparagraphs — Article 29(1), third, fourth and fifth subparagraphs — Article 29(2) Article 17(2), first and second subparagraphs — Article 17(2), third subparagraph Article 29(10), third subparagraph Article 17(3), first subparagraph, point (a) Article 29(3), first subparagraph, point (a) — Article 29(3), first subparagraph, point (b) Article 17(3), first subparagraph, points (b) and (c) Article 29(3), first subparagraph, points (c) and (d) — Article 29(3), second subparagraph Article 17(4) Article 29(4) Article 17(5) Article 29(5) Article 17(6) and (7) — — Article 29(6), (7), (8), (9), (10) and (11) Article 17(8) Article 29(12) Article 17(9) — — Article 29(13) and (14) Article 18(1), first subparagraph Article 30(1), first subparagraph Article 18(1), first subparagraph, points (a), (b) and (c) Article 30(1), first subparagraph, points (a), (c) and (d) — Article 30(1), first subparagraph, point (b) — Article 30(1), second subparagraph Article 18(2) — — Article 30(2) Article 18(3), first subparagraph Article 30(3), first subparagraph Article 18(3), second and third subparagraphs — Article 18(3), fourth and fifth subparagraphs Article 30(3), second and third subparagraphs Article 18(4), first subparagraph — Article 18(4), second and third subparagraphs Article 30(4), first and second subparagraphs Article 18(4), fourth subparagraph — Article 18(5), first and second subparagraphs Article 30(7), first and second subparagraphs Article 18(5), third subparagraph Article 30(8), first and second subparagraphs Article 18(5), fourth subparagraph Article 30(5), third subparagraph — Article 30(6), first subparagraph Article 18(5), fifth subparagraph Article 30(6), second subparagraph Article 18(6), first and second subparagraphs Article 30(5), first and second subparagraphs Article 18(6), third subparagraph — Article 18(6), fourth subparagraph Article 30(6), third subparagraph — Article 30(6), fourth subparagraph Article 18(6), fifth subparagraph Article 30(6), fifth subparagraph Article 18(7) Article 30(9), first subparagraph — Article 30(9), second subparagraph Article 18(8) and (9) — — Article 30(10) Article 19(1), first subparagraph Article 31(1), first subparagraph Article 19(1), first subparagraph, points (a), (b) and (c) Article 31(1), first subparagraph, points (a), (b) and (c) — Article 31(1), first subparagraph, point (d) Article 19(2), (3) and (4) Article 31(2), (3) and (4) Article 19(5) — Article 19(7), first subparagraph Article 31(5), first subparagraph Article 19(7), first subparagraph, first, second third and fourth indents — Article 19(7), second and third subparagraphs Article 31(5), second and third subparagraphs Article 19(8) Article 31(6) Article 20 Article 32 Article 22 — Article 23(1) and (2) Article 33(1) and (2) Article 23(3), (4), (5), (6), (7) and (8) — Article 23(9) Article 33(3) Article 23(10) Article 33(4) Article 24 — Article 25(1) Article 34(1) Article 25(2) Article 34(2) Article 25(3) Article 34(3) Article 25a(1) Article 35(1) Article 25a(2) Article 35(2) and (3) Article 25a(3) Article 35(4) — Article 35(5) Article 25a(4) and (5) Article 35(6) and (7) Article 26 — Article 27 Article 36 — Article 37 Article 28 Article 38 Article 29 Article 39 Annex I Annex I Annex II Annex II Annex III Annex III Annex IV Annex IV Annex V Annex V Annex VI — — Annex VI Annex VII Annex VII Annex VIII Annex VIII Annex IX Annex IX — Annex X — Annex XI

Renewable energy Renewable energy SUMMARY OF: Directive (EU) 2018/2001 on the promotion of the use of energy from renewable sources WHAT IS THE AIM OF THE DIRECTIVE? It recasts and repeals previous legislation (Directive 2009/28/EC, Directive (EU) 2015/1513 and Council Directive 2013/18/EU). It establishes a common system to promote energy from renewable sources* across the different sectors. In particular, it aims to: set a binding EU target for its share in the energy mix in 2030;regulate self-consumption for the first time; andestablish a common set of rules for the use of renewables in electricity, heating and cooling, and transport in the EU. The increased use of energy from renewable sources will be crucial to combat climate change, protect our environment and reduce our energy dependency, as well as to contribute to the EU’s technological and industrial leadership and the creation of jobs and growth, including in rural and isolated areas. KEY POINTS Promoting renewable forms of energy is one of the goals of EU energy policy. The increased use of energy from renewable sources is an important part of the package of measures needed to reduce greenhouse gas emissions and to comply with the 2015 Paris Agreement on Climate Change and the EU policy framework for climate and energy (2020 to 2030). This recast directive, along with the revised Energy Efficiency Directive and a new Governance Regulation, is part of the Clean Energy for All Europeans package, which aims to provide new, comprehensive rules on energy regulation for the next decade. The directive: ensures that the EU’s binding target is achieved cost-effectively; establishes a stable, market-oriented European approach to renewable electricity; provides long-term certainty for investors and speeds up procedures for permits to build projects; enables consumers to take part in the energy transition with the right to produce their own renewable energy; increasing the use of renewables in the heating and cooling and the transport sectors; strengthens EU sustainability criteria for bioenergy. The directive includes: a binding EU overall target for 2030 of at least 32% of energy from renewable sources; rules for cost-effective and market-based financial support for electricity from renewable sources; protection of support schemes from modifications which put existing projects at risk; cooperation mechanisms between EU countries, and between EU countries and non-EU countries; simplification of administrative procedures for renewables projects (including one-stop-shops, time-limits, and digitalisation); an improved guarantee of origin system, extended to all renewables; rules allowing consumers to produce their own electricity, individually or as part of renewable energy communities, without undue restrictions; in the heating and cooling sector: an annual increase of 1.3 percentage points in the share of renewable energy in the sectorthe right for consumers to disconnect from inefficient district heating and cooling systems andthird-party access for suppliers of renewables and waste heat and cooling to district heating and cooling networks; in the transport sector: a binding target of 14% witha specific sub-target for advanced biofuels of 3.5% andcaps on conventional biofuels and on high indirect land use change risk* biofuels; strengthened EU sustainability criteria for bioenergy, by extending their scope to cover all fuels produced from biomass regardless of their final energy use. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 24 December 2018 and has to become law in EU countries by 30 June 2021. BACKGROUND For more information, see: Renewable energy (European Commission). KEY TERMS Energy from renewable sources: energy from renewable non-fossil sources, such as wind, solar (thermal and photovoltaic), aerothermal, geothermal, hydrothermal, ambient heat, tide, wave and other ocean energy, hydropower, biomass, landfill gas, sewage treatment plant gas and biogases. Indirect land use change risk: changes in land use are brought about by growing more crops for ethanol or biodiesel production in response to the increased global demand for biofuels. There can be unintended consequences, including releasing more carbon emissions. MAIN DOCUMENT Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (recast) (OJ L 328, 21.12.2018, pp. 82-209) RELATED DOCUMENTS Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, pp. 1-77) Directive (EU) 2018/2002 of the European Parliament and of the Council of 11 December 2018 amending Directive 2012/27/EU on energy efficiency (OJ L 328, 21.12.2018, pp. 210-230) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, pp. 1-56) See consolidated version. Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140, 5.6.2009, pp. 16-62) last update 31.01.2019

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22.1.2021 EN Official Journal of the European Union L 22/1 REGULATION (EU) 2021/23 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national Parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the European Central Bank (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Financial markets are pivotal for the functioning of modern economies. The more integrated they are, the greater the potential for efficient allocation of economic resources will be, potentially benefitting economic performance. However, in order to improve the functioning of the single market in financial services, it is important to have procedures in place to deal with effects of market turmoil and to ensure that if a financial institution or a financial market infrastructure that is active in this market faces financial distress or is at the point of failure, such an event does not de-stabilise the entire financial market and damage growth across the wider economy. (2) Central counterparties (CCPs) are key components of global financial markets, stepping in between participants to act as the buyer to every seller and the seller to every buyer, and playing a central role in processing financial transactions and managing exposures to diverse risks inherent in those transactions. CCPs centralise the handling of transactions and positions of counterparties, honour the obligations created by the transactions, and require adequate collateral from their members as margin and as contributions to default funds. (3) The integration of Union financial markets has resulted in CCPs evolving from primarily serving domestic needs and markets to constituting critical nodes in Union financial markets more widely. CCPs authorised in the Union today clear several product classes, including listed and over-the-counter (OTC) financial and commodity derivatives, cash equities, bonds and other products such as repos. They provide services across national borders to a broad range of financial and other institutions across the Union. While some CCPs remain focused on domestic markets, they are all systemically important at least in their home markets. (4) As a significant amount of the financial risk of the Union financial system is processed by and concentrated in CCPs on behalf of clearing members and their clients, effective regulation and robust supervision of CCPs are essential. Regulation (EU) No 648/2012 of the European Parliament and of the Council (4) requires CCPs authorised in the Union to observe high prudential, organisational and conduct of business standards. Competent authorities, working together within supervisory colleges which group together relevant authorities for the specific tasks allocated to them, are tasked with the full oversight of the activities of CCPs. In accordance with commitments entered into by G20 leaders since the 2008 financial crisis, Regulation (EU) No 648/2012 also requires standardised OTC derivatives to be centrally cleared by a CCP. As the obligation to centrally clear OTC derivatives comes into effect, the volume and range of business done by CCPs is likely to increase which could, in turn, provide additional challenges for risk management strategies of CCPs. (5) Regulation (EU) No 648/2012 has contributed to the increased resilience of CCPs and of wider financial markets against the broad range of risks processed and concentrated in CCPs. However, no system of rules and practices can prevent existing resources from being inadequate in managing the risks incurred by a CCP, including one or more defaults by clearing members. Faced with a scenario of severe financial distress or impending failure, financial institutions should in principle remain subject to normal insolvency proceedings. However, as the 2008 financial crisis has shown, in particular during a period of prolonged economic instability and uncertainty, such proceedings can disrupt functions critical to the economy, jeopardising financial stability. Normal corporate insolvency procedures may not always ensure sufficient speed of intervention or adequately prioritise the continuity of the critical functions of financial institutions for the sake of preserving financial stability. In order to prevent such negative consequences of normal insolvency proceedings, it is necessary to create a special resolution framework for CCPs. (6) The 2008 financial crisis highlighted the lack of adequate tools to preserve the critical functions provided by failing financial institutions. It further demonstrated the absence of frameworks to enable cooperation and coordination amongst authorities, in particular those located in different Member States or jurisdictions, to ensure the taking of swift and decisive action. Without such tools and in the absence of cooperation and coordination frameworks, Member States were compelled to rescue financial institutions using taxpayer money in order to stem contagion and reduce panic. While CCPs were not direct recipients of extraordinary public financial support in the 2008 financial crisis, they were protected from the effects that banks failing to perform their obligations would otherwise have had on them. A recovery and resolution framework for CCPs complements the bank resolution framework adopted under Directive 2014/59/EU of the European Parliament and of the Council (5), and is therefore necessary to prevent reliance on taxpayer money in the event of their disorderly failure. Such a framework should also address the possibility of CCPs entering into resolution for reasons other than the default of one or several of their clearing members. (7) The objective of a credible recovery and resolution framework is to ensure, to the greatest extent possible, that CCPs set out measures to recover from financial distress, to maintain the critical functions of a CCP which is failing or likely to fail while winding up the remaining activities through normal insolvency proceedings, and to preserve financial stability and to avoid a significant adverse effect on the financial system and its ability to serve the real economy while minimising the cost to taxpayers of a CCP failure. A recovery and resolution framework further bolsters the preparedness of CCPs and authorities to mitigate financial distress and provide authorities with further insight into CCPs’ preparations for stress scenarios. It also provides authorities with powers to prepare for the potential resolution of a CCP and deal with the declining health of a CCP in a coordinated manner, thus contributing to the smooth functioning of financial markets. (8) Currently, there are no harmonised provisions for the recovery and resolution of CCPs across the Union. Some Member States have already enacted legislative changes that require CCPs to draw up recovery plans and that introduce mechanisms to resolve failing CCPs. Furthermore, there are considerable substantive and procedural differences between Member States on the laws, regulations and administrative provisions which govern the insolvency of CCPs. The absence of common conditions, powers and processes for the recovery and resolution of CCPs is likely to constitute a barrier to the smooth functioning of the internal market and hinder cooperation between national authorities when dealing with the failure of a CCP and applying appropriate loss allocation mechanisms on its clearing members, both in the Union and globally. This is particularly true where different approaches mean that national authorities do not have the same level of control or the same ability to resolve CCPs. Those differences in recovery and resolution regimes might affect CCPs, clearing members and the clients of clearing members differently across Member States, potentially creating competitive distortions across the internal market. The absence of common rules and tools for how financial distress or failure in a CCP should be handled can affect clearing members’ and their clients’ choice to clear and CCPs’ choice of their place of establishment, thereby preventing CCPs from fully benefiting from their fundamental freedoms within the internal market. In turn, this could discourage clearing members and their clients from accessing CCPs across borders in the internal market and hinder further integration in the Union’s capital markets. Common recovery and resolution rules in all Member States are therefore necessary to ensure that CCPs are not limited in exercising their internal market freedoms by the financial capacity of Member States and their authorities to manage their failure. (9) The review of the regulatory framework applicable to banks and to other financial institutions which has taken place in the wake of the 2008 financial crisis, and in particular the strengthening of banks’ capital and liquidity buffers, better tools for macro-prudential policies and comprehensive rules on the recovery and resolution of banks, have reduced the likelihood of future crises and enhanced the resilience of all financial institutions and market infrastructures, including CCPs, to economic stress, whether caused by systemic disturbances or by events specific to individual institutions. Since 1 January 2015, a recovery and resolution regime for banks has applied in Member States pursuant to Directive 2014/59/EU. (10) Building on the approach for bank recovery and resolution, competent authorities and resolution authorities should be prepared and have adequate tools at their disposal to handle situations involving CCP failures. However, due to their different functions and business models, the risks inherent in banks and CCPs are different. Specific tools and powers are therefore needed for CCP failure scenarios caused by the failure of the CCP’s clearing members or as a result of non-default events. (11) A regulation is the proper legal act to choose in order to complement and build on the approach established by Regulation (EU) No 648/2012, which provides for uniform prudential requirements applicable to CCPs. Setting recovery and resolution requirements in a directive could create inconsistencies by the adoption of potentially different national rules in respect of an area otherwise governed by directly applicable Union law and increasingly characterised by the cross-border provision of CCPs’ services. Therefore uniform and directly applicable rules on recovery and resolution of CCPs should also be adopted. (12) In order to ensure consistency with existing Union legislation in the area of financial services, as well as the greatest possible level of financial stability across the Union, the recovery and resolution regime laid down in this Regulation should apply to CCPs that are subject to the prudential requirements laid down in Regulation (EU) No 648/2012, regardless of whether they have a banking licence. While there might be differences in the risk profile associated with alternative corporate structures, CCPs are stand-alone entities that are required to fulfil all requirements under this Regulation and under Regulation (EU) No 648/2012 independently from their parent undertaking or other group entities. The group of which a CCP forms part does not therefore need to be subject to this Regulation. The group dimension, including, inter alia, the operational, personal and financial relations of a CCP with group entities, should, however, be taken into account in the CCP’s recovery and resolution planning insofar it could affect the recovery or resolution of the CCP or insofar recovery and resolution actions could have an impact on other entities of the group. (13) In order to ensure that resolution actions are taken efficiently and effectively, and in line with resolution objectives, Member States should appoint, as resolution authorities for the purpose of this Regulation, national central banks, competent ministries, public administrative authorities or authorities entrusted with public administrative powers to perform functions and tasks in relation to resolution, including any existing resolution authorities. Member States should also ensure that appropriate resources are allocated to those resolution authorities. In Member States where a CCP is established, adequate structural arrangements should be put in place to separate the CCP resolution functions from other functions, in particular where the authority responsible for the prudential supervision of the CCP, or prudential supervision of credit institutions or investment firms that are clearing members of the CCP, is designated as the resolution authority, to avoid any conflicts of interest and risk of regulatory forbearance. In such cases, the independence of the resolution authority’s decision-making process should be ensured, while not preventing decision-making from converging at the highest level. (14) In light of the consequences that the failure of a CCP and the subsequent actions might have on the financial system and the economy of a Member State, as well as the possible ultimate need to use public funds to resolve a crisis, the Ministries of Finance or other relevant ministries in Member States should be able to decide, in line with national democratic procedures, on the use of public funds as a last resort and should consequently be closely involved, at an early stage, in the process of recovery and resolution. Therefore, with regard to the use of public funds as a last resort, this Regulation should be without prejudice to the distribution of competences between the relevant ministries or the government and the resolution authority as provided for in the legal systems of Member States. (15) As CCPs often provide services across the Union, effective recovery and resolution requires cooperation among competent authorities and resolution authorities within supervisory and resolution colleges, notably at the preparatory stages of recovery and resolution. That includes assessing the recovery plan developed by the CCP, contributing to and reaching a joint decision on resolution plans drawn up by the resolution authority of the CCP, and addressing any impediments to resolvability of the CCP. (16) The resolution of CCPs should strike the balance between the need, on the one hand, for procedures that take into account the urgency of the situation and allow for efficient, fair and timely solutions and, on the other, the necessity to protect financial stability in the Member States where the CCP provides services. The authorities whose areas of competence would be affected by the failure of a CCP should share their views in the resolution college to achieve those objectives. This should include in particular sharing information on the preparation of clearing members and, where relevant, clients with regard to potential default management, recovery and resolution measures and the supervisory treatment of the related exposures towards the CCP. The authorities of Member States whose financial stability could be impacted by the failure of the CCP should be able to participate in the resolution college based on their assessment of the impact that the CCP’s resolution could have on financial stability in their respective Member State. Member States should have the possibility to be represented in the resolution college by the competent authorities and resolution authorities of clearing members. Member States which are not represented by clearing members’ authorities should be able to participate by choosing between participation in the college of the competent authority of clearing members’ clients and of the resolution authority of clearing members’ clients. The authorities should provide appropriate justification for their participation, based on their analysis of the negative impact that the CCP’s resolution could have on their Member States, to the resolution authority of the CCP. Similarly, in order to ensure a regular exchange of views and coordination with relevant third-country authorities, these should be invited to participate in resolution colleges as observers where necessary. (17) In order to address the potential failure of a CCP in an effective and proportionate manner, authorities should take into account a number of factors when exercising their recovery and resolution powers such as the nature of the CCP’s business, ownership structure, legal and organisational structure, risk profile, size, legal status, substitutability and interconnectedness to the financial system. The authorities should also take account of whether its failure and subsequent winding up under normal insolvency proceedings would be likely to have a significant negative effect on financial markets, on other financial institutions, or on the wider economy. (18) In order to deal in an efficient manner with failing CCPs, competent authorities should have the power to impose preparatory measures on CCPs. A minimum standard should be established as regards the contents and information to be included in recovery plans to ensure that all CCPs in the Union have sufficiently detailed recovery plans should they face financial distress. Such recovery plan should contemplate an appropriate range of scenarios, envisaging both systemic and specific stresses to the CCP, that would endanger its viability, also taking into account the potential impact of contagion in a crisis, both domestic and cross-border. The scenarios should be more severe than those used for the purposes of regular stress testing pursuant to Article 49 of Regulation (EU) No 648/2012, while remaining plausible. The recovery plan should cover a broad range of scenarios including scenarios resulting from default events, non-default events and a combination of both; and should include comprehensive arrangements for the re-establishment of a matched book, for the full allocation of losses arising from clearing member default, and adequate absorbency for all other types of losses. Recovery plans should distinguish between different types of non-default events. The recovery plan should form part of the operating rules of the CCP agreed contractually with clearing members. Those operating rules should further contain provisions to ensure the enforceability of recovery measures outlined in the recovery plan in all scenarios. Recovery plans should not assume access to extraordinary public financial support or expose taxpayers to the risk of loss. (19) CCPs should be required to draw up and regularly review and update their recovery plans. The recovery phase in that context should start when there is a significant deterioration in the CCP’s financial situation or risk of breach of its capital and prudential requirements under Regulation (EU) No 648/2012 that could lead to the infringement of its authorisation requirements that would justify the withdrawal of its authorisation pursuant to Regulation (EU) No 648/2012. This should be indicated with reference to a framework of qualitative or quantitative indicators included in the recovery plan. (20) In order to create sound incentives ex-ante and to ensure a fair allocation of losses, recovery plans should ensure that the application of recovery tools appropriately balances the allocation of losses between CCPs, clearing members and, where applicable, their clients. As a general principle, losses in recovery should be distributed between CCPs, clearing members, and, where applicable, their clients as a function of their responsibility for the risk transferred to the CCP and their ability to control and manage such risks. Recovery plans should ensure that the CCP’s capital is exposed to losses caused by both default and non-default events, before losses are allocated to clearing members. As an incentive for proper risk management and to further reduce the risks of losses for the taxpayer, the CCP should use a portion of its pre-funded dedicated own resources as referred to in Article 43 of Regulation (EU) No 648/2012, which can include any capital it holds in addition to its minimum capital requirements, to comply with the notification threshold referred to in the delegated act adopted on the basis of Article 16(3) of Regulation (EU) No 648/2012, as a recovery measure before resorting to other recovery measures requiring financial contributions from clearing members. That additional amount of pre-funded dedicated own resources, which is distinct from the pre-funded own resources referred to in Article 45(4) of Regulation (EU) No 648/2012, should not be lower than 10 % nor higher than 25 % of the risk based capital requirements calculated in accordance with Article 16(2) of Regulation (EU) No 648/2012 irrespective of whether those requirements are lower or higher than the initial capital referred to in Article 16(1) of that Regulation. (21) The CCP should submit its recovery plan to the competent authority which should without undue delay transmit the plan to the supervisory college, established under Regulation (EU) No 648/2012, for a complete assessment, to be carried out by joint decision of the college. The assessment should include whether the plan is comprehensive and whether it could feasibly restore the viability of the CCP, in a timely manner, including in periods of severe financial distress. (22) Recovery plans should comprehensively set out the actions that the CCP would take to address any unmatched outstanding obligations, uncovered loss, liquidity shortfall, or capital inadequacy, as well as the actions to replenish any depleted pre-funded financial resources and liquidity arrangements in order to restore the CCP’s viability and its continuing ability to meet its requirements for authorisation. Neither the power of the resolution authority to apply a resolution cash call nor the requirement to have a minimum contractual commitment for the recovery cash call should affect the right of the CCP to introduce recovery cash calls in its rules above the minimum obligatory contractual commitment specified in this Regulation or the risk management of the CCP. (23) Recovery plans should also consider cyber-attacks which could lead to a significant deterioration of the financial situation of the CCP or to a risk of breaching prudential requirements under Regulation (EU) No 648/2012. (24) CCPs should ensure that their recovery plan is non-discriminatory and balanced in terms of its impact and the incentives it creates. The effects of the recovery measures on clearing members and, where the relevant information is available, their clients and on the financial system of the Union or of one or more of its Member States more broadly should be proportionate. In particular, in accordance with Regulation (EU) No 648/2012 CCPs have to ensure that their clearing members have limited exposures toward the CCP. CCPs should ensure that all relevant stakeholders are involved in the drawing-up of the recovery plan through their involvement in the CCP’s risk committee, as the case might be, and by being appropriately consulted. Since opinions can be expected to differ among stakeholders, CCPs should establish clear processes to manage the diversity of stakeholders’ views as well as any conflict of interest between those stakeholders and the CCP. (25) In view of the global nature of the markets served by CCPs, the CCP’s operating rules should include contractual provisions to ensure its ability to apply the recovery options, where necessary, to contracts or assets governed by the law of a third country or to entities based in third countries. (26) Where a CCP does not present an adequate recovery plan, competent authorities should be able to require the CCP to take the measures necessary to redress the material deficiencies of the plan in order to strengthen the business of the CCP and ensure that the CCP could allocate losses, restore its capital and, where relevant, re-match its book in the event of failure. That power should allow competent authorities to take preventive action to the extent that it is necessary to address any deficiencies and, therefore, to meet the objectives of financial stability. (27) In the exceptional cases of variation margin gains haircutting following a non-default event and if recovery is successful, the competent authority should be able to require the CCP to recompense its clearing members proportionately to their loss in excess of their contractual commitments, through cash payments or, where appropriate, to require the CCP to issue instruments recognising a claim on the future profits of the CCP. (28) Resolution planning is an essential component of effective resolution. The plans should be drawn up by the resolution authority of the CCP and jointly agreed in the resolution college. The plans should cover a broad range of scenarios, distinguishing scenarios resulting from default events, non-default events and a combination of both, as well as different types of non-default events. Authorities should have all the information necessary to identify and ensure the continuity of critical functions. The content of a resolution plan should, however, be appropriate to the activities of the CCP and the types of products it clears and it should be based, inter alia, on the information provided by it. In order to facilitate the enforcement of resolution cash calls and of the reduction of the amount of any gains payable to a non-defaulting clearing member of a CCP under resolution, a reference to the power of the resolution authority to require such resolution cash calls and such reduction should be included in the operating rules of the CCP. Where needed, the operating rules of the CCP that are agreed contractually with clearing members should contain provisions to ensure the enforceability of other resolution measures by resolution authorities. (29) Resolution authorities, on the basis of the assessment of resolvability, should have the power to require changes to the legal or operational structure and organisation of CCPs directly or indirectly through the competent authority, to take measures which are necessary and proportionate to reduce or remove material impediments to the application of resolution tools and ensure their resolvability. Taking into account the diverse structure of the groups that CCPs belong to, the differences in structures compared to banking groups, and the different regulatory frameworks that apply to individual entities within such groups, the resolution authority of the CCP, in consultation with the competent authority of the CCP, should be able to assess whether enforcing changes to the legal or operational structures of the CCP, or any group entity directly or indirectly under its control, involves changes in the structures of the group that the CCP belongs to that could lead to issues of legal challenge or issues of enforceability, depending on the specific legal circumstances that apply. The resolution authority, when assessing how to remove such impediments to resolution, should be able to suggest a different set of resolvability measures than requiring changes to the legal or operational structures of the group, if the use of such alternative measures would remove the impediments to resolvability in an equivalent way. (30) As regards resolution plans and resolvability assessments day-to-day supervisory considerations are outweighed by the need to expedite and ensure swift restructuring actions in order to secure a CCP’s critical functions and safeguard financial stability. In the event of disagreement between the different members of the resolution college on decisions to be taken with regard to the CCP’s resolution plan, the assessment of the CCP’s resolvability and the decision to remove any impediments thereto, the European Supervisory Authority (European Securities and Markets Authority) (ESMA) should play a mediation role in accordance with Article 19 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (6). Such binding mediation by ESMA should nonetheless be prepared for consideration by an ESMA internal committee, in view of the competences of ESMA members to ensure financial stability and to oversee clearing members in several Member States. Certain competent authorities under the Regulation (EU) No 1093/2010 of the European Parliament and of the Council (7) should be invited to participate as observers to that ESMA internal committee in view of the fact that such authorities carry out similar tasks under Directive 2014/59/EU. Such binding mediation should not prevent non-binding mediation in accordance with Article 31 of Regulation (EU) No 1095/2010 in other cases. In accordance with Article 38 of Regulation (EU) No 1095/2010, such binding mediation may not impinge on the fiscal responsibilities of Member States. (31) It could be necessary for the recovery plan of the CCP to set out the conditions under which the provision of possible contractually binding financial support agreements, guarantees or other forms of operational support from a parent undertaking or another group entity to a CCP within the same group would be triggered. Transparency regarding such arrangements would mitigate risks to the liquidity and solvency of the group entity providing support to a CCP facing financial distress. Therefore, any change to such arrangements affecting the quality and nature of such group support should be considered a material change for the purpose of reviewing the recovery plan. (32) Given the sensitivity of the information contained in the recovery and resolution plans, those plans should be subject to appropriate confidentiality provisions. (33) Competent authorities should transmit the recovery plans and any changes thereto to the relevant resolution authorities, and the latter should transmit the resolution plans and any changes thereto to competent authorities, thus permanently keeping every relevant authority fully informed. (34) In order to preserve financial stability, it is necessary that competent authorities are able to remedy the deterioration of a CCP’s financial and economic situation before that CCP reaches a point at which authorities have no other alternative but to resolve it or to direct the CCP to change its recovery measures where they could be detrimental for overall financial stability. Competent authorities should therefore be granted early intervention powers to avoid or minimise adverse effects on financial stability or on the interests of clients that could result from the CCP’s implementation of certain measures. Early intervention powers should be conferred on competent authorities in addition to their powers provided for in the national law of Member States or under Regulation (EU) No 648/2012 for circumstances other than those considered to be early intervention. Early intervention powers should include the power to restrict or prohibit any remuneration of equity and instruments treated as equity, including dividend payments and buybacks by the CCP, to the fullest extent possible without triggering an event of default, and also the power to restrict, prohibit or freeze any payments of variable remuneration as defined by the CCP’s remuneration policy pursuant to Article 26(5) of Regulation (EU) No 648/2012, discretionary pension benefits or severance packages to senior management. (35) In the framework of early intervention powers, and in accordance with the relevant provisions under national law, the competent authority should be able to appoint a temporary administrator, either to replace or to temporarily work with the board and senior management of the CCP. The task of the temporary administrator should be to exercise any powers conferred on it, subject to any condition imposed on it upon its appointment, with a view to promoting solutions to redress the financial situation of the CCP. The appointment of the temporary administrator should not unduly interfere with the rights of the shareholders or owners or with procedural obligations established under Union or national company law and should respect international obligations of the Union and Member States, relating to investment protection. (36) During the recovery and early intervention phases, shareholders should retain their rights in full. They should lose such rights once the CCP has been put under resolution. Any remuneration of equity and instruments treated as equity, including dividend payments and buybacks by the CCP, should be restricted or prohibited in recovery, to the fullest extent possible without triggering an event of default. Equity holders of a CCP should absorb losses first in resolution in a way that minimises the risk of legal challenge by them where such losses are greater than the losses that they would have incurred under normal insolvency proceedings also known as the ‘no creditor worse off’ principle. A resolution authority should be able to deviate from the ‘no creditor worse off’ principle. However, a shareholder or a creditor incurring greater loss than it would have incurred under normal insolvency proceedings would be entitled to the payment of the difference. (37) The resolution framework should provide for timely entry into resolution before a CCP is insolvent. A CCP should be considered to be failing or likely to fail when it infringes or is likely in the near future to infringe the requirements for continuing authorisation, when its recovery has failed or is likely to fail to restore its viability, when the CCP is unable or is likely to be unable to provide a critical function, when the assets of the CCP are or are likely in the near future to be less than its liabilities, when the CCP is or is likely in the near future to be unable to pay its debts or other liabilities as they fall due, or when the CCP requires extraordinary public financial support. However, the fact that a CCP does not comply with all the requirements for authorisation should not justify by itself the entry into resolution. (38) The provision of emergency liquidity assistance from a central bank, where such a facility is available, should not be a condition that demonstrates that a CCP is or will be, in the near future, unable to pay its liabilities as they fall due. In order to preserve financial stability, in particular in the case of a systemic liquidity shortage, State guarantees on liquidity facilities provided by central banks or State guarantees of newly issued liabilities to remedy a serious disturbance in the economy of a Member State should not trigger entry into resolution, provided that a number of conditions are met. (39) Members of the European System of Central Banks (ESCB), other Member States’ bodies performing similar functions, other Union public bodies charged with or intervening in the management of the public debt, and the Bank for International Settlements as well as other entities listed in Article 1(4) and (5) of Regulation (EU) No 648/2012 can act in the capacity of a clearing member in connection with their operations. Loss allocation tools envisaged in the recovery plan of CCPs should not apply to those entities. Similarly, resolution authorities should not apply loss allocation tools with regard to those entities, in order to avoid the exposure of public money. (40) Where a CCP meets the conditions for resolution, the resolution authority of the CCP should have at its disposal a harmonised set of resolution tools and powers. They should enable the resolution authority to address scenarios caused both by default and non-default events, or a combination of both. Their exercise should be subject to common conditions, objectives, and general principles. In particular, the application of such tools or powers should not impinge on the effective resolution of cross-border groups. (41) The prime objectives of resolution should be to ensure the continuity of critical functions, to avoid adverse effects on financial stability, and to protect public funds. (42) The critical functions of a failing CCP should be maintained, although re-structured with changes to the management where appropriate, through the application of resolution tools and, to the largest extent possible, with the use of private funds and without reliance on extraordinary public financial support. That objective could be achieved by allocating outstanding losses and restoring the CCP to a matched book through application of the position and loss allocation tools in the case of default losses, or, in the case of non-default losses, through the write-down of equity instruments and the write-down and conversion to equity of unsecured liabilities to absorb losses and recapitalise the CCP. To prevent the need for the application of government stabilisation tools, the resolution authority should also be able to use the resolution cash call following a non-default event. A CCP or specific clearing service should also be able to be sold to or merged with a solvent third-party CCP that is able to conduct and manage the transferred clearing activities. In line with the objective of maintaining the critical functions of the CCP and prior to taking the actions described above, the resolution authority should generally enforce any existing and outstanding contractual obligations towards the CCP in line with how they would be called in its operating rules, including in particular any contractual obligations by clearing members to meet recovery cash calls or to take on positions of defaulting clearing members, whether through an auction or other agreed means in the CCP’s operating rules, as well as any existing and outstanding contractual obligations committing parties other than clearing members to any forms of financial support. (43) Rapid and decisive action is necessary to sustain market confidence and minimise contagion. Once the conditions for resolution have been met, the resolution authority of the CCP should not delay in taking appropriate and coordinated resolution action in the public interest. The failure of a CCP can occur in circumstances that require an immediate reaction by the relevant resolution authority. That authority should therefore be allowed to take resolution actions notwithstanding the exercise of recovery measures by the CCP or without imposing an obligation to first use the early intervention powers. (44) When taking resolution actions, the resolution authority of the CCP should take into account and follow the measures provided for in the resolution plans drawn up within the resolution college, unless the resolution authority considers, taking into account the circumstances of the case, that the resolution objectives will be achieved more effectively by taking actions which are not provided for in the resolution plans. The resolution authority should take into account the general principles of decision-making, including the need to balance the interests of different stakeholders of the CCP and to ensure transparency towards and involvement of the relevant authorities of Member States where the proposed decision or action could have implications on the financial stability or fiscal resources. In particular, the resolution authority should inform the resolution college of the planned resolution actions, including where such actions deviate from the resolution plan. (45) Interference with property rights should be proportionate to the financial stability risk. Resolution tools should therefore be applied only with respect to those CCPs that meet the conditions for resolution, specifically where it is necessary to pursue the objective of financial stability in the public interest. Resolution tools and powers could disrupt the rights of shareholders, creditors, clearing members and, where applicable, clients of clearing members. Resolution action should therefore be taken only where necessary in the public interest and any interference with those rights should be compatible with the Charter of Fundamental Rights of the European Union (‘the Charter’). (46) Affected shareholders, clearing members and other creditors of the CCP should not incur losses greater than those which they would have incurred if the resolution authority had not taken resolution action in relation to the CCP and they had instead been subject to all applicable outstanding obligations pursuant to the CCP’s default rules or other contractual arrangements in its operating rules, and the CCP had been wound up in normal insolvency proceedings (‘no creditor worse off’ principle). In the event of a partial transfer of assets of a CCP under resolution to a private purchaser or to a bridge CCP, the residual part of the CCP under resolution should be wound up under normal insolvency proceedings. (47) For the purpose of protecting the rights of shareholders, of clearing members and of other creditors, clear rules should be laid down concerning the valuation of the assets and liabilities of the CCP and the valuation of the treatment that shareholders, clearing members and other creditors would have received if the resolution authority had not taken resolution action. This should compare the treatment that shareholders, clearing members and other creditors have actually been afforded in resolution and the treatment they would have received if the resolution authority had not taken resolution action in relation to the CCP and if they had instead been subject to possible outstanding obligations pursuant to the CCP’s recovery plan or other arrangements in its operating rules and the CCP had been wound up in normal insolvency proceedings. The use of the resolution cash call, which should be included in the CCP’s operating rules, is reserved for the resolution authority. It cannot be used by the CCP, or an administrator or liquidator in insolvency and it should therefore not be part of the treatment that shareholders, clearing members and other creditors would have received if the resolution authority had not taken resolution action. Any use of the power to reduce the amount of any gains payable to a non-defaulting clearing member by the resolution authority that exceeds contractually agreed limits for such a reduction should also not be part of the treatment that shareholders, clearing members and other creditors would have received if the resolution authority had not taken resolution action. Where shareholders, clearing members and other creditors have received, in payment of, or compensation for, their claims, less than the amount that they would have received if the resolution authority had not taken resolution action in relation to the CCP and they had instead been subject to possible outstanding obligations pursuant to the CCP’s default rules or other contractual arrangements in its operating rules and the CCP had been wound up in normal insolvency proceedings, they should be entitled to the payment of the difference. Clients should only be included in that comparison and should only be entitled to the payment of any difference in treatment when there is a contractual basis for a direct claim from clients against the CCP, making them creditors of the CCP. Only in such cases can the resolution authority control the direct impact of its actions. It should be possible to challenge that comparison separately from the resolution decision. Member States should be free to decide on the procedure as to how to pay any difference of treatment that has been determined to shareholders, clearing members and other creditors. (48) Recovery and resolution actions can indirectly affect clients and indirect clients that are not creditors of the CCP, to the extent that costs of recovery and resolution have been passed to those clients and indirect clients under the applicable contractual arrangements. Therefore, the impact of a CCP recovery and resolution scenario on clients and indirect clients should also be addressed through the same contractual arrangements with the clearing members and clients that provide them with clearing services. This can be achieved by ensuring that, if contractual arrangements allow clearing members to pass on to their clients the negative consequences of the resolution tools, those contractual arrangements also include, on an equivalent and proportionate basis, the right of clients to any compensation clearing members receive from the CCP or any cash equivalent of such compensation or any proceeds they receive following a ‘no creditor worse off’ claim, to the extent that these relate to client positions. Such provisions should also apply to the contractual arrangements by clients and indirect clients offering indirect clearing services to their clients. (49) To ensure the effective resolution of a CCP, the valuation process should determine as accurately as possible any losses that need to be allocated for the CCP to re-establish a matched book of outstanding positions and to meet ongoing payment obligations. The valuation of assets and liabilities of a failing CCP should be based on fair, prudent and realistic assumptions at the moment when the resolution tools are applied. The value of liabilities should not, however, be affected in the valuation by the financial state of the CCP. It should be possible, for reasons of urgency, for resolution authorities to make a rapid valuation of the assets or the liabilities of a failing CCP. That valuation should be provisional and should apply until an independent valuation is carried out. (50) Upon entry into resolution of the CCP, the resolution authority should enforce any outstanding contractual obligations set out in the operating rules of the CCP, including outstanding recovery measures, except where the exercise of another resolution power or tool is more appropriate to mitigate adverse effects for financial stability or to secure the critical functions of the CCP in a timely manner. The resolution authority should have the right, but not the obligation, to enforce those contractual obligations still after resolution if the reasons for refraining from their enforcement no longer exist. In order to allow for the clearing members and other relevant parties to prepare for the enforcement of the remaining obligations, the resolution authority should notify the relevant clearing members and other parties in advance. That pre-notification period should be from three to six months. The resolution authority should determine, in consultation with the competent authorities and resolution authorities of the affected clearing members and any other parties committed by existing and outstanding obligations, whether the reasons for refraining from enforcing the contractual obligations have ceased to exist and whether to enforce the remaining obligations. If the reasons continue to exist, the resolution authority should refrain from enforcing those obligations. The proceeds from the delayed enforcement of the outstanding contractual obligations should be used to recover any public funds used for the payment of ‘no creditor worse off’ claims resulting from the resolutions authority’s decision to refrain from enforcing those obligations or the application of any government stabilisation tool. The resolution authority should use this power of delayed enforcement only to the extent that the ‘no creditor worse off’ safeguard is not breached with respect to the stakeholder that will be subject to the delayed enforcement. In the case of default losses, the resolution authority should restore the CCP to a matched book and allocate outstanding losses through application of position and loss allocation tools. In the case of non-default losses, losses should be absorbed by regulatory capital instruments and should be allocated to shareholders up to their capacity either through the cancellation or transfer of instruments of ownership or through severe dilution. Where those instruments are not sufficient, resolution authorities should have the power to write-down unsecured debt and liabilities, in accordance with their ranking under applicable national insolvency law, and apply loss allocation tools, to the extent necessary without jeopardising broader financial stability. (51) If, after losses have been absorbed and, where applicable, the CCP has been restored to a matched book and the pre-funded resources of the CCP remain depleted, the resolution authority should ensure that those resources are restored to the levels necessary to meet regulatory requirements, either through the continued exercise of the tools in the CCP’s operating rules or through other actions. In particular, resolution authorities should have the possibility to compensate non-defaulting clearing members that would have been entitled to a ‘no creditor worse off’ compensation payment for the application of loss allocation tools that would result in losses in excess of those that the clearing members would have borne under their obligations under the CCP’s operating rules with instruments of ownership, debt instruments or instruments recognising a claim on the CCP’s future profits. When assessing the amount and the form of compensation, the resolution authority can consider, for example, the financial soundness of the CCP, and the quality of instruments available for compensation and for meeting the ‘no creditor worse off’ safeguard. To maintain an adequate incentive structure, such compensation should reflect the extent to which a clearing member has supported the recovery of the CCP and therefore also take into account the remaining outstanding contractual obligations of the clearing members towards that CCP. Such compensation should be deducted from any entitlement to a ‘no creditor worse off’ payment. (52) Resolution authorities should also ensure that the costs of the resolution of the CCP are minimised and that creditors of the same class are treated in an equitable manner. The resolution authority should be able to take a resolution action which deviates from the principle of equal treatment of creditors if it is justified in the public interest to achieve the resolution objectives and is proportionate to the risk addressed. If the resolution authority uses such measure it should not discriminate anybody on the basis of nationality. (53) The resolution of a CCP should not entail calling on extraordinary public financial support. The outstanding recovery tools and resolution tools, in particular the write-down tool, should be applied to the fullest extent possible before or together with any public sector injection of capital or equivalent extraordinary public financial support is given to a CCP. The use of extraordinary public financial support to assist in the resolution of failing institutions is to be a last resort, be limited in time and comply with the relevant State aid provisions. (54) An effective resolution regime should minimise the costs of the resolution of a failing CCP borne by the taxpayers. It should ensure that CCPs can be resolved without jeopardising financial stability. The write-down tool and the loss and position allocation tools should achieve that objective by ensuring that shareholders and counterparties who are among the creditors of the failing CCP suffer appropriate losses and bear an appropriate part of the costs arising from the failure of the CCP. The write-down and the loss and position allocation tools therefore give shareholders and counterparties of CCPs a stronger incentive to monitor the health of a CCP during normal circumstances in accordance with the recommendations of the Financial Stability Board (FSB) provided for in its document ‘Key Attributes of Effective Resolution Regimes for Financial Institutions’. (55) In order to ensure that resolution authorities have the necessary flexibility to allocate losses and positions to counterparties in a range of circumstances, it is appropriate that those authorities should be able to apply the position and loss allocation tools both where the objective is to maintain critical clearing services within the CCP under resolution and in conjunction with the transfer of critical services to a bridge CCP or a third party after which the residual part of the CCP ceases to operate and is wound up. (56) Where the position and loss allocation tools are applied with the objective of restoring the viability of the failing CCP to enable it to continue to operate as a going concern, the resolution should be accompanied by replacement of management, except where retention of management is appropriate and necessary for the achievement of the resolution objectives, and a subsequent restructuring of the CCP and its activities in a way that addresses the reasons for its failure. That restructuring should be achieved through the implementation of a business reorganisation plan, which should be compatible with the restructuring plan that the CCP might be required to submit pursuant to the State aid framework. (57) The position and loss allocation tools should be exercised with a view to re-matching the CCP’s book, stemming any further losses and obtaining additional resources to help recapitalise the CCP and replenish its pre-funded resources. In order to ensure that they are effective and achieve their objective, they should be able to apply to as wide a range of contracts giving rise to unsecured liabilities or creating an unmatched book for the failing CCP as possible. They should provide for the possibility to auction defaulters’ positions among remaining clearing members or to forcibly allocate them to the extent that voluntary arrangements established as part of recovery plan are not exhausted upon entry into resolution, to partially or fully terminate the contracts of defaulted clearing members, of an affected clearing service or asset class and other contracts of the CCP, to further haircut outgoing variation margin payments to such members and, where applicable, their clients, to exercise any outstanding recovery cash calls set out in recovery plans, and to exercise additional resolution cash calls and write-down of capital and debt instruments issued by the CCP or other unsecured liabilities and a conversion of any debt instruments into shares. This includes the possibility to apply the loss allocation tools to contribute to the restoration of a matched book by providing the CCP with funds to accept an auction bid, enabling the CCP to allocate the defaulter’s positions or to make payments on the terminated contracts. (58) When applying the loss allocation tool that allows the reduction of the value of any gains payable by the CCP to non-defaulting clearing members, the resolution authority should rely on processing of variation margin in accordance with the CCP’s account structure, the operation of the reduction of the value of any gains payable by the CCP to non-defaulting clearing members in recovery, if applicable, and the ‘no creditor worse off’ principle. (59) With due respect for the impact on financial stability and as a last resort, resolution authorities should be able to exclude or partially exclude some contracts from position and loss allocation in a number of circumstances. Where such exclusions are applied, it should be possible to increase the level of exposure or loss applied to other contracts to take account of such exclusions subject to the ‘no creditor worse off’ principle being respected. (60) Where the resolution tools have been applied to transfer the critical functions or viable business of a CCP to a sound entity such as a private sector purchaser or bridge CCP, the residual part of the CCP should be liquidated within an appropriate time frame having regard to any need for the failing CCP to provide services or support to enable the purchaser or bridge CCP to carry out the activities or provide the services acquired by virtue of that transfer. (61) The sale of business tool should enable authorities to sell the CCP or parts of its business to one or more purchasers without the consent of shareholders. When applying the sale of business tool, authorities should make arrangements for the marketing of that CCP or part of its business in an open, transparent and non-discriminatory process, while aiming to maximise, as far as possible, the sale price. (62) Any net proceeds from the transfer of assets or liabilities of the CCP under resolution when applying the sale of business tool should benefit the entity left in the winding up proceedings. Any net proceeds from the transfer of instruments of ownership issued by the CCP under resolution when applying the sale of business tool should benefit the shareholders. Any consideration paid by the purchaser should also benefit any non-defaulting clearing members that have suffered losses. Any such net proceeds or benefit should be subject to the full recoupment of any public fund provided in resolution. Proceeds should be calculated net of the costs that have arisen from the failure of the CCP and from the resolution process. (63) In order to perform the sale of business in a timely manner and protect financial stability, the assessment of the buyer of a qualifying holding should be carried out in a timely manner that does not delay the application of the sale of business tool. The CCP, the purchaser or both, depending on the effects of the sale of business tool and the form of acquisition, should be able to exercise or maintain existing rights of membership and accessing payment and settlement systems and other linked financial market infrastructures and trading venues. Such rights should not be denied on the basis either of non-compliance with the relevant criteria for membership or participation, or of insufficient credit rating. A purchaser who does not meet those criteria can only exercise such rights for a period to be specified by the resolution authority. (64) Information concerning the marketing of a failing CCP and the negotiations with potential acquirers prior to the application of the sale-of-business tool is likely to be of systemic importance. In order to ensure financial stability, it is important that it is possible for the disclosure to the public of such information required under Regulation (EU) No 596/2014 of the European Parliament and of the Council (8) to be delayed for the time necessary to plan and structure the resolution of the CCP in accordance with delays permitted under the market abuse regime. (65) As a CCP which is wholly or partially owned by one or more public authorities or controlled by the resolution authority, a bridge CCP should have as its main purpose ensuring that essential financial services continue to be provided to the clearing members and clients of the CCP that had been placed under resolution and that essential financial activities continue to be performed. The bridge CCP should be operated as a viable going concern entity and be put back on the market when conditions are appropriate or wound up if it is no longer viable. (66) Where all other options are unavailable or demonstrably insufficient to safeguard financial stability, government participation in the shape of equity support or temporary public ownership should be possible, in accordance with applicable rules on State aid, including a restructuring of the operations of the CCP. In order to avoid moral hazard, such extraordinary public financial support should be provided only as a last resort, be temporary in nature and always be recovered over an appropriate period. Therefore, while not constituting an obstacle to applying government stabilisation tools, comprehensive and credible arrangements for the recoupment of funds should be established by Member States. The application of government stabilisation tools is without prejudice to the role of any central bank in potentially providing liquidity to the financial system, at the central bank’s exclusive discretion, even in times of stress. (67) To ensure the ability of a resolution authority to apply the loss and position allocation tools to contracts with entities based in third countries, recognition of that possibility should be included in the operating rules of the CCP. (68) Resolution authorities should have all the necessary legal powers that, in different combinations, could be exercised when applying the resolution tools. They should include the power to transfer instruments of ownership, assets, rights, obligations or liabilities of a failing CCP to another entity such as another CCP or a bridge CCP, the power to write down or cancel instruments of ownership, or write down or convert liabilities of a failing CCP, the power to write down variation margin, the power to enforce any outstanding obligations of third parties in relation to the CCP, including recovery cash calls, as set out in the CCP’s operating rules, and position allocations, the power to exercise resolution cash calls, the power to terminate contracts of the CCP partially and fully, the power to replace the management and the power to impose a temporary moratorium on the payment of claims. The CCP and the members of its board and senior management should remain liable, subject to national civil or criminal law, for the failure of the CCP. (69) The resolution framework should include procedural requirements to ensure that resolution actions are properly notified and made public. However, as information obtained by resolution authorities and their professional advisers during the resolution process is likely to be sensitive, before the resolution decision is made public, it should be subject to an effective confidentiality regime. The fact that information on the contents and details of recovery and resolution plans and the result of any assessment of those plans could have far-reaching effects, in particular on the undertakings concerned, must be taken into account. Any information provided in respect of a decision before it is taken, be it on whether the conditions for resolution are satisfied, on the application of a specific tool or of any action during the proceedings, must be presumed to have effects on the public and private interests concerned by the action. Information that the resolution authority is examining a specific CCP could be enough for there to be negative effects on that CCP. It is therefore necessary to ensure that there are appropriate mechanisms for maintaining the confidentiality of such information, such as the content and details of recovery and resolution plans and the result of any assessment carried out in that context. (70) Resolution authorities should have ancillary powers to ensure the effectiveness of the transfer of instruments of ownership or debt instruments and assets, liabilities, rights and obligations, including positions and related margins. Subject to the safeguards specified in this Regulation, those powers should include the power to remove the rights of third parties from the transferred instruments or assets and the power to enforce contracts and to provide for the continuity of arrangements vis-à-vis the recipient of the transferred assets and instruments of ownership. However, the rights of employees to terminate a contract of employment should not be affected. The right of a party to terminate a contract with a CCP under resolution, or a group entity thereof, for reasons other than the resolution of the failing CCP should not be affected either. Resolution authorities should have the ancillary power to require the residual CCP that is being wound up under normal insolvency proceedings to provide services that are necessary to enable the CCP to which assets, contracts or instruments of ownership have been transferred by virtue of the application of the sale of business tool or the bridge CCP tool to operate its business. (71) Given that crisis management measures could be required to be taken urgently due to serious financial stability risks in the Member State and the Union, any procedure under national law relating to the application for ex-ante judicial approval of a crisis management measure and the court’s consideration of such an application should be expeditious. Given the requirement for a crisis management measure to be taken urgently, the court should give its decision within 24 hours and Member States should ensure that the relevant authority can take its decision immediately after the court’s decision. This should be without prejudice to the right of interested parties to request the court to set aside the decision for a limited period after the resolution authority has taken the crisis management measure. (72) In accordance with Article 47 of the Charter, the parties concerned have the right to due process and to an effective remedy against the measures affecting them. The decisions taken by the resolution authorities should therefore be subject to the right of appeal. (73) Resolution action taken by national resolution authorities might require economic assessments and a large margin of discretion. The national resolution authorities are specifically equipped with the expertise needed for making those assessments and for determining the appropriate use of the margin of discretion. Therefore, it is important to ensure that the economic assessments made by national resolution authorities in that context are used as a basis by national courts when reviewing the crisis management measures concerned. However, the complex nature of those assessments should not prevent national courts from examining whether the evidence relied on by the resolution authority is factually accurate, reliable and consistent, whether that evidence contains all relevant information which should be taken into account in order to assess a complex situation and whether it is capable of substantiating the conclusions drawn therefrom. (74) In order to cover situations of extreme urgency and since the suspension of any decision of the resolution authorities might impede the continuity of critical functions, it is necessary to provide that the lodging of any appeal should not result in automatic suspension of the effects of the challenged decision and that the decision of the resolution authority should be immediately enforceable. (75) In addition, where necessary in order to protect third parties who have acquired assets, contracts, rights and liabilities of the CCP under resolution in good faith by virtue of the exercise of the resolution powers by the resolution authorities and to ensure the stability of the financial markets, a right of appeal should not affect any subsequent administrative act or transaction concluded on the basis of an annulled decision. In such cases, remedies for a wrongful decision should therefore be limited to the award of compensation for the damages suffered by the affected persons. (76) In the interest of efficient resolution, and in order to avoid conflicts of jurisdiction, no normal insolvency proceedings for the failing CCP should be opened or continued whilst the resolution authority is exercising its resolution powers or applying the resolution tools, except at the initiative or with the consent of the resolution authority. It is useful and necessary to suspend, for a limited period, certain contractual obligations so that the resolution authority has time to put into practice the resolution tools. However, this should not apply to obligations of a failing CCP towards systems designated under Directive 98/26/EC of the European Parliament and of the Council (9), including other CCPs and central banks. Directive 98/26/EC reduces the risk associated with participation in payment and securities settlement systems, in particular by reducing disruption in the event of the insolvency of a participant in such a system. In order to ensure that those protections apply appropriately in crisis situations, whilst maintaining appropriate certainty for operators of payment and securities settlement systems and other market participants, crisis prevention measures or resolution actions should not be deemed to be insolvency proceedings within the meaning of Directive 98/26/EC, provided that the substantive obligations under the contract continue to be performed. However, the operation of a system designated under or the right to collateral security guaranteed by, Directive 98/26/EC should not be undermined. (77) In order to ensure that resolution authorities, when transferring assets and liabilities to a private sector purchaser or bridge CCP, have an adequate period to identify contracts that need to be transferred, it might be appropriate to impose proportionate restrictions on the rights of counterparties to close out, accelerate or otherwise terminate financial contracts before the transfer is made. Such a restriction would be necessary to allow authorities to obtain a true picture of the balance sheet of the failing CCP, without the changes in value and scope that extensive exercise of termination rights would entail. In order to interfere with the contractual rights of counterparties to the minimum extent necessary, the restriction on termination rights should be limited to the shortest period possible and apply only in relation to the crisis prevention measure or resolution action, including the occurrence of any event directly linked to the application of such a measure, and the rights to terminate arising from any other default, including failure to pay or deliver margins, should remain. (78) In order to preserve legitimate capital market arrangements in the event of a transfer of some, but not all, of the assets, contracts, rights and liabilities of a failing CCP, it is appropriate to include safeguards to prevent, as appropriate, the splitting of linked liabilities, rights and contracts. Such a restriction on selected practices in relation to linked contracts and related collateral should extend to contracts with the same counterparty covered by security arrangements, title transfer financial collateral arrangements, set-off arrangements, close out netting arrangements, and structured finance arrangements. Where the safeguard applies, resolution authorities should seek to transfer all linked contracts within a protected arrangement, or leave them all with the residual failing CCP. Those safeguards should ensure that the regulatory capital treatment of exposures covered by a netting arrangement for the purposes of Directive 2013/36/EU of the European Parliament and of the Council (10) is affected to a minimum degree. (79) Union CCPs provide services to clearing members and their clients located in third countries and third-country CCPs provide services to clearing members and their clients located in the Union. Effective resolution of internationally active CCPs requires cooperation between Member States and third-country authorities. For that purpose ESMA should provide guidance on the relevant content of cooperation arrangements to be concluded with authorities of third countries. Those cooperation arrangements should ensure effective planning, decision-making and coordination in respect of internationally active CCPs. National resolution authorities should recognise and enforce third-country resolution proceedings in certain circumstances. Cooperation should also take place with regard to subsidiaries of Union or third-country CCPs and their clearing members and their clients. (80) In order to ensure the consistent application of administrative penalties across Member States for breaches of this Regulation, this Regulation should provide for a list of key administrative penalties and other administrative measures that need to be available to the resolution authorities and the competent authorities, for the power to impose those administrative penalties and other administrative measures on all persons, whether legal or natural, responsible for an infringement, and for a list of key criteria when determining the level and type of those administrative penalties and other administrative measures and for levels of administrative pecuniary penalties. Administrative penalties and other administrative measures should take into account factors such as any identified financial benefit resulting from the infringement, the gravity and duration of the infringement, any aggravating or mitigating factors, the need for administrative fines to have a deterrent effect and, where appropriate, include a discount for cooperation with the resolution authority or the competent authority. The adoption and publication of administrative penalties should respect fundamental rights as laid down in the Charter. (81) In order to ensure consistent harmonisation and adequate protection for market participants across the Union, the Commission should be empowered to adopt draft regulatory technical standards developed by ESMA by means of delegated acts pursuant to Article 290 of the Treaty on the Functioning of the European Union (TFEU), in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010 to specify the following elements: (a) the content of the written arrangements and procedures for the functioning of the resolution colleges; (b) the methodology for calculation and maintenance of the amount of the additional pre-funded dedicated own resources to be used by the CCP in recovery and the procedures, where such own resources are not available, for the CCP to resort to recovery measures that require contributions of non-defaulting clearing members and to subsequently reimburse such clearing members; (c) the assessment methodology for recovery plans; (d) the contents of resolution plans; (e) the order of allocation, maximum period and maximum share of the CCP’s annual profits under the recompense mechanism in recovery; (f) elements relevant to the conduct of valuations; (g) methodology for calculating the buffer for additional losses to be included in provisional valuations; (h) the minimum elements that should be included in a business reorganisation plan; (i) criteria that a business reorganisation plan is to fulfil; (j) the methodology for final valuation under the ‘no credit worse off’ principle; (k) the conditions for clearing members to pass on compensation to their clients in line with the contractual symmetry principle and the conditions under which it is to be considered proportionate. (82) The Commission should be able to suspend any clearing obligation established pursuant to Article 5 of Regulation (EU) No 648/2012, following a request from the resolution authority of a CCP under resolution or its competent authority, on their own initiative or at the request of the competent authority responsible for the supervision of a clearing member of the CCP under resolution, and following a non-binding opinion by ESMA, for a specific type of counterparty or for specific classes of OTC derivatives which are cleared by a CCP under resolution. The decision to suspend the clearing obligation should be adopted only if it is necessary to preserve financial stability and market confidence, in particular to avoid contagion effects and to prevent counterparties and investors having high and uncertain risk exposures to a CCP. In order to adopt its decision, the Commission should take into account the resolution objectives, the criteria stated in Regulation (EU) No 648/2012 for subjecting OTC derivatives to the clearing obligation regarding those OTC derivatives for which the suspension is requested and whether it is necessary to suspend the clearing obligation in order to preserve financial stability and the orderly functioning of financial markets in the Union. ESMA should be able to request the Commission to suspend the trading obligation laid down in Regulation (EU) No 600/2014 of the European Parliament and of the Council (11) where it considers the suspension of the clearing obligation to be a material change in the criteria for the trading obligation. The suspension should be of a temporary nature with a possibility of extension. Likewise, the role of the CCP’s risk committee, as set out in Article 28 of Regulation (EU) No 648/2012, should be enhanced to further encourage the CCP to manage its risks prudently and improve its resilience. Members of the risk committee should be able to inform the competent authority when the CCP does not follow the risk committee’s advice, and representatives of clearing members and clients on the risk committee should be able to use information provided to monitor their exposures to the CCP, in accordance with confidentiality safeguards and without prejudice to the limitations to the exchange of such information laid out in competition law. Finally, resolution authorities of CCPs should also have access to all necessary information in trade repositories. Regulation (EU) No 648/2012 and Regulation (EU) 2015/2365 of the European Parliament and of the Council (12) should therefore be amended accordingly. (83) In order to ensure the proper implementation of the interest rate benchmark reform of the FSB it is necessary to provide clarity to market participants that transactions entered into or novated before the entry into application of the clearing or margin requirements to OTC derivative transactions referencing an interest rate benchmark (legacy trades) will not be subject to the requirements as provided for in Regulation (EU) No 648/2012 when they are novated for the sole purpose of implementing or preparing for the implementation of the interest rate benchmark reform. Doing so should also prevent any risk that Union counterparties to those legacy trades find themselves unprepared when a specific benchmark is materially changed or discontinued, therefore alleviating related financial stability concerns. Such approach is in line with the international guidance from the Basel Committee on Banking Supervision (BCBS) and the International Organization of Securities Commissions (IOSCO). (84) In order to implement resolution of CCPs effectively, the safeguards provided for in Directive 2002/47/EC of the European Parliament and of the Council (13) should not apply to any restriction on the enforcement of a financial collateral arrangement or on the effect of a security financial collateral arrangement, any close-out netting or set-off provision provided for in this Regulation. (85) Directives (EU) 2017/1132 (14), 2004/25/EC (15) and 2007/36/EC (16) of the European Parliament and of the Council contain rules on the protection of shareholders and creditors of CCPs that fall within the scope of those Directives. In a situation where resolution authorities need to act rapidly under this Regulation, those rules might hinder effective resolution action and application of resolution tools and powers by resolution authorities. Derogations under Directive 2014/59/EU should therefore be extended to actions taken pursuant to this Regulation. In order to guarantee the maximum degree of legal certainty for stakeholders, the derogations should be clearly and narrowly defined, and should only be used in the public interest and when resolution triggers are met. (86) In order to avoid duplication of requirements, Directive 2014/59/EU and Regulation (EU) No 806/2014 of the European Parliament and of the Council (17) should be amended to exclude from their scope those entities that are also authorised in accordance with Regulation (EU) No 648/2012. (87) Article 54(2) of Regulation (EU) No 600/2014 provides for a transitional period during which Article 35 or 36 of that Regulation would not apply to those CCPs or trading venues which applied to their competent authority to benefit from the transitional arrangements, in respect of exchange-traded derivatives. The transitional period during which a trading venue or a CCP can be exempted by its national competent authority, in respect of exchange-traded derivatives from the application of Articles 35 and 36 of that Regulation expired on 3 July 2020. The current market environment, with a high degree of uncertainty and volatility driven by the COVID-19 pandemic, negatively impacts CCPs and trading venues’ operations by increasing their operational risks. Those increased risks, combined with limited capacity for assessing access requests and for managing the migration of transactions flows, might impact the orderly functioning of markets or financial stability. In addition, that Regulation provides for a novel exchange-traded derivatives regime on access to critical market infrastructures which aims to balance more competition amongst those infrastructures with the need to preserve their operational integrity. Therefore, while that Regulation seeks to create a competitive market for financial infrastructures, economic operators should not expect that existing rules and priorities are maintained when economic circumstances change as a consequence, in particular, of a major economic crisis. This is particularly the case in an area where the interaction between critical market infrastructures, such as trading and clearing infrastructures, requires an exceptional level of operational resilience, as any failures in such critical infrastructures would pose a high risk to financial stability. As a consequence of the COVID-19 pandemic, the application date of the new open access regime for trading venues and CCPs offering trading and clearing services in relation to exchange-traded derivatives is postponed by one year, until 3 July 2021. (88) In order to ensure that resolution authorities of CCPs are represented in all relevant fora, and to ensure that ESMA benefits from all expertise necessary to carry out the tasks related to the recovery and resolution of CCPs, Regulation (EU) No 1095/2010 should be amended in order to include national CCP resolution authorities in the concept of competent authorities established by that Regulation. (89) In order to prepare the decisions of ESMA in relation to the tasks allocated to it involving the development of draft technical standards on ex-ante and ex-post valuations and on resolution colleges and resolution plans, and of guidelines on the conditions for resolution, and on binding mediation, and to ensure the comprehensive involvement of the European Supervisory Authority (European Banking Authority) (EBA) and its members in the preparation of those decisions, ESMA should create an internal committee (the ‘ESMA Resolution Committee’) with resolution authorities as members. Where relevant, competent authorities defined in Regulation (EU) No 575/2013 of the European Parliament and of the Council (18), including the European Central Bank, and resolution authorities as defined in Directive 2014/59/EU, including the Single Resolution Board established by Regulation (EU) No 806/2014, should be invited to participate as observers. (90) The ESMA Resolution Committee should be consulted in the preparation of the conceptual framework for the assessments of the resilience of CCPs to adverse market developments, when this assessment includes the aggregate effect of CCP recovery and resolution arrangements on Union financial stability. In such cases, the ESMA Resolution Committee should also be consulted when the findings of such stress tests are being assessed. (91) This Regulation respects the fundamental rights and observes the rights, freedoms and principles recognised by the Charter. (92) When taking decisions or actions under this Regulation, competent authorities and resolution authorities should always have due regard to the impact of their decisions and actions on financial stability in other Member States and on the economic situation in other Member States where the CCP’s operations are critical or important for local financial markets, including where clearing members and, where relevant information is available, their clients are located and where linked trading venues and financial market infrastructures, including interoperable CCPs, are established. (93) Since the objective of this Regulation, namely the harmonisation of the rules and processes for the recovery and resolution of CCPs, cannot be sufficiently achieved by the Member States, but can rather, by reason of the effects of a failure of any CCPs in the whole Union, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (94) The application of this Regulation should be deferred until 12 August 2022 to establish all essential implementing measures and to allow CCPs and other market participants to take the necessary steps for compliance purposes. However, the requirement for the CCP to use dedicated own resources in recovery and the provisions to recompense clearing members in the extraordinary case of applying variation margin gains haircutting in recovery, rely on the appropriate regulatory technical standards to be in place. It is therefore appropriate to extend the deferral of the date of application for such provision until 12 February 2023. Additionally, certain provisions that apply to CCP recovery plans and the adoption and review of recovery plans, including the obligation to submit a recovery plan, should be applied from an earlier date, since all CCPs already have recovery plans, as required by the Principles for Financial Market Infrastructures published by the Committee on Payments and Market Infrastructures and the IOSCO. CCPs already authorised under Regulation (EU) No 648/2012 should take the appropriate steps to ensure that they will be able to submit their recovery plans to their competent authorities at the latest on 12 February 2022. Those provisions related to recovery plans should be applied from 12 February 2022. If the resolution authority had not been consulted on the recovery plan of the CCP, once the other provisions of this Regulation become applicable, the competent authority of the CCP should consult the resolution authority on the CCP’s recovery plan without delay. In order to ensure legal certainty for counterparties, the amendments to Regulation (EU) No 648/2012 intended to ensure the proper implementation of the FSB’s interest rate benchmark reform should apply from the date of entry into force of this Regulation. (95) In order to ensure that increased operational risks stemming from the application of the open access regime for exchange-traded derivatives do not endanger the orderly functioning of markets or financial stability and to avoid any discontinuity, it is necessary to retroactively apply the extension of such transitional periods from 4 July 2020 until 3 July 2021. (96) This Regulation should ensure that CCPs have sufficient loss-absorbing and recapitalisation capacity to ensure smooth and fast absorption of losses and recapitalisation with a minimum impact on financial stability while aiming to avoid an impact on taxpayers. Consistently with the internationally agreed principles for effective resolution regimes for financial institutions developed by the FSB, this Regulation should ensure that equity holders of a CCP absorb losses first in resolution in a way that minimises the risk of legal challenge by equity holders, on the basis that their losses in resolution are greater than the losses that they would have incurred under normal insolvency proceedings according to the ‘no creditor worse off’ principle. On 15 November 2018, the FSB published a consultation paper entitled ‘Financial resources to support CCP resolution and the treatment of CCP equity in resolution’. Based on the feedback received to that paper and further assessments, the FSB plans to issue guidance at the end of 2020 on how equity should be used in the event of resolution of CCPs in a manner that minimises the risk of legal challenge by equity holders resulting from the application of the ‘no creditor worse off’ principle. Following the publication of that guidance, the Commission should review the application of the rules laid down in this Regulation with regard to the write-down of equity in resolution by taking into account those internationally agreed standards. In addition to this specific review, the Commission should review the application of this Regulation after five years from the date of its entry into force, inter alia, by taking into account any further international developments. That general review should cover at least certain core matters related to the recovery and resolution of CCPs, such as financial resources available to resolution authorities to cover non-default losses and the CCPs’ own resources to be used in recovery and resolution, HAVE ADOPTED THIS REGULATION: TITLE I SUBJECT MATTER AND DEFINITIONS Article 1 Subject matter This Regulation lays down rules and procedures relating to the recovery and resolution of central counterparties (CCPs) authorised in accordance with Regulation (EU) No 648/2012 and rules relating to arrangements with third countries in the field of recovery and resolution of CCPs. Article 2 Definitions For the purposes of this Regulation the following definitions apply: (1) ‘CCP’ means a CCP as defined in point (1) of Article 2 of Regulation (EU) No 648/2012; (2) ‘resolution college’ means the college established pursuant to Article 4; (3) ‘resolution authority’ means an authority designated by a Member State in accordance with Article 3; (4) ‘resolution tool’ means a resolution tool as set out in Article 27(1); (5) ‘resolution power’ means any of the powers laid down in Articles 48 to 58; (6) ‘resolution objectives’ mean the resolution objectives laid down in Article 21; (7) ‘competent authority’ means an authority designated by a Member State in accordance with Article 22 of Regulation (EU) No 648/2012; (8) ‘default event’ means a scenario in which the CCP has declared in default: (a) one or more clearing members in accordance with the procedure set out in Article 48 of Regulation (EU) No 648/2012; or (b) one or more interoperable CCPs in accordance with the relevant contractual arrangements or with the procedure set out in Article 52 of Regulation (EU) No 648/2012; (9) ‘non-default event’ means a scenario in which losses are incurred by a CCP for any reason other than a default event, including but not limited to, business, custody, investment, legal or operational failures or fraud, including failures resulting from cyber-attacks; (10) ‘resolution plan’ means a resolution plan for a CCP drawn up in accordance with Article 12; (11) ‘resolution action’ means a decision to place a CCP under resolution pursuant to Article 22, the application of a resolution tool, or the exercise of one or more resolution powers; (12) ‘clearing member’ means a clearing member as defined in point 14 of Article 2 of Regulation (EU) No 648/2012; (13) ‘parent undertaking’ means a parent undertaking as defined in point (15)(a) of Article 4(1) of Regulation (EU) No 575/2013; (14) ‘third-country CCP’ means a CCP the head office of which is established in a third country; (15) ‘set-off arrangement’ means an arrangement under which two or more claims or obligations owed between the CCP under resolution and a counterparty can be set off against each other; (16) ‘financial market infrastructure’ or ‘FMI’ means a CCP, a central securities depository, a trade repository, a payment system or another system defined and designated by a Member State under point (a) of Article 2 of Directive 98/26/EC; (17) ‘trading venue’ means a trading venue as defined in point 4 of Article 2 of Regulation (EU) No 648/2012; (18) ‘client’ means a client as defined in point 15 of Article 2 of Regulation (EU) No 648/2012; (19) ‘O-SIIs’ means other systemically important institutions as referred to in Article 131(3) of Directive 2013/36/EU; (20) ‘indirect client’ means an undertaking which has established indirect clearing arrangements with a clearing member within the meaning of the second subparagraph of Article 4(3) of Regulation (EU) No 648/2012; (21) ‘interoperable CCP’ means a CCP with which an interoperability arrangement has been established; (22) ‘recovery plan’ means a recovery plan drawn up and maintained by a CCP in accordance with Article 9; (23) ‘board’ means the administrative or supervisory board, or both, set up pursuant to national company law and in accordance with Article 27(2) of Regulation (EU) No 648/2012; (24) ‘supervisory college’ means the college referred to in Article 18(1) of Regulation (EU) No 648/2012; (25) ‘capital’ means capital as defined in point 25 of Article 2 of Regulation (EU) No 648/2012; (26) ‘default waterfall’ means default waterfall in accordance with Article 45 of Regulation (EU) No 648/2012; (27) ‘critical functions’ means activities, services or operations provided to third parties external to the CCP the discontinuance of which is likely to lead to the disruption of services that are essential to the real economy or to disrupt financial stability in one or more Member States due to the size, market share, external and internal interconnectedness, complexity or cross-border activities of a CCP, with particular regard to the substitutability of those activities, services or operations; (28) ‘group’ means a group as defined in point 16 of Article 2 of Regulation (EU) No 648/2012; (29) ‘linked FMI’ means an FMI with which the CCP has entered into contractual arrangements, including interoperability arrangements; (30) ‘extraordinary public financial support’ means State aid within the meaning of Article 107(1) of the Treaty on the Functioning of the European Union (TFEU), or any other public financial support at supra-national level, which, if provided for at national level, would constitute State aid, that is provided in order to preserve or restore the viability, liquidity or solvency of a CCP; (31) ‘financial contracts’ means contracts and agreements as defined in point 100 of Article 2(1) of Directive 2014/59/EU; (32) ‘normal insolvency proceedings’ means collective insolvency proceedings which entail the partial or total divestment of a debtor and the appointment of a liquidator or an administrator normally applicable to CCPs under national law and either specific to those institutions or generally applicable to any natural or legal person; (33) ‘instruments of ownership’ means shares, other instruments that confer ownership, instruments that are convertible into or give the right to acquire shares or other instruments of ownership, and instruments representing interests in shares or other instruments of ownership; (34) ‘designated national macroprudential authority’ means the authority entrusted with the conduct of macroprudential policy referred to in Recommendation B1 of the Recommendation of the European Systemic Risk Board (ESRB) of 22 December 2011 on the macroprudential mandate of national authorities (ESRB/2011/3); (35) ‘default fund’ means a default fund maintained by a CCP in accordance with Article 42 of Regulation (EU) No 648/2012; (36) ‘pre-funded resources’ means resources which are held by and freely available to the relevant legal person; (37) ‘senior management’ means the person or persons who effectively direct the business of the CCP, and the executive member or members of the board; (38) ‘trade repository’ means a trade repository as defined in point 2 of Article 2 of Regulation (EU) No 648/2012 or in point 1 of Article 3 of Regulation (EU) 2015/2365 of the European Parliament and of the Council (19); (39) ‘Union State aid framework’ means the framework established by Articles 107, 108 and 109 TFEU and regulations and all Union acts, including guidelines, communications and notices, made or adopted pursuant to Article 108(4) or Article 109 TFEU; (40) ‘debt instruments’ means bonds or other forms of unsecured transferable debt, instruments creating or acknowledging a debt, and instruments giving rights to acquire debt instruments; (41) ‘initial margin’ means margins collected by the CCP to cover potential future exposure to clearing members providing the margin and, where relevant, interoperable CCPs in the interval between the last margin collection and the liquidation of positions following a default of a clearing member or of an interoperable CCP; (42) ‘variation margin’ means margins collected or paid out to reflect current exposures resulting from actual changes in market prices; (43) ‘resolution cash call’ means a request for cash resources to be provided by clearing members to the CCP, additional to pre-funded resources, based on statutory powers available to a resolution authority in accordance with Article 31; (44) ‘recovery cash call’ means a request for cash resources, other than a resolution cash call, to be provided by clearing members to the CCP, additional to pre-funded resources, based on contractual arrangements laid out in the operating rules of the CCP; (45) ‘transfer powers’ means the powers specified in point (c) and (d) of Article 48(1) to transfer shares, other instruments of ownership, debt instruments, assets, rights, obligations or liabilities, or any combination of those items from a CCP under resolution to a recipient; (46) ‘derivative’ means a derivative as defined in point 5 of Article 2 of Regulation (EU) No 648/2012; (47) ‘netting arrangement’ means an arrangement under which a number of claims or obligations can be converted into a single net claim, including a close-out netting arrangement under which, on the occurrence of an enforcement event (however or wherever defined), the obligations of the parties are accelerated so as to become immediately due or are terminated, and in either case are converted into or replaced by a single net claim, including a close-out netting provision as defined in point (n)(i) of Article 2(1) of Directive 2002/47/EC of the European Parliament and of the Council (20) and netting as defined in point (k) of Article 2 of Directive 98/26/EC; (48) ‘crisis prevention measure’ means the exercise of powers to require a CCP to take measures to remedy deficiencies in its recovery plan under Article 10(8) and (9), the exercise of powers to address or remove impediments to resolvability under Article 16, or the application of an early intervention measure under Article 18; (49) ‘termination right’ means a right to terminate a contract, a right to accelerate, close out, set-off or net obligations or any similar provision that suspends, modifies or extinguishes an obligation of a party to the contract or a provision that prevents an obligation under the contract from arising that would otherwise arise; (50) ‘title transfer financial collateral arrangement’ means a title transfer financial collateral arrangement as defined in point (b) of Article 2(1) of Directive 2002/47/EC; (51) ‘covered bond’ means a covered bond as defined in point (1) of Article 3 of Directive (EU) 2019/2162 of the European Parliament and of the Council (21); (52) ‘third-country resolution proceedings’ means an action under the law of a third country to manage the failure of a third-country CCP that is comparable, in terms of objectives and anticipated results, to resolution actions under this Regulation; (53) ‘relevant national authorities’ means the resolution authorities, competent authorities or competent ministries designated in accordance with this Regulation or pursuant to Article 3 of Directive 2014/59/EU or other authorities in Member States with powers in relation to assets, rights, obligations or liabilities of third-country CCPs providing clearing services in their jurisdiction; (54) ‘relevant third-country authority’ means a third-country authority responsible for carrying out functions comparable to those of resolution authorities or competent authorities pursuant to this Regulation. TITLE II AUTHORITIES, RESOLUTION COLLEGE AND PROCEDURES Section 1 Resolution authorities, resolution colleges and involvement of European Supervisory Authorities Article 3 Designation of resolution authorities and competent ministries 1. Each Member State shall designate one or more resolution authorities that are empowered to apply the resolution tools and exercise the resolution powers as set out in this Regulation. Resolution authorities shall be national central banks, competent ministries, public administrative authorities or other authorities entrusted with public administrative powers. 2. Resolution authorities shall have the expertise, resources and operational capacity to apply resolution measures and exercise their powers with the speed and flexibility that are necessary to achieve the resolution objectives. 3. Where a resolution authority designated pursuant to paragraph 1 of this Article is entrusted with other functions, adequate structural arrangements shall be in place to avoid conflicts of interest between the functions entrusted to the resolution authority pursuant to this Regulation and all other functions entrusted to that authority. In particular, arrangements shall be put in place to ensure effective operational independence, including separate staff, reporting lines and decision making process of that resolution authority, from any tasks that the resolution authority may perform pursuant to Article 22 of Regulation (EU) No 648/2012 as a competent authority of the CCP and from the tasks that the resolution authority may perform as the competent authority of the clearing members referred to in point (c) of Article 18(2) of Regulation (EU) No 648/2012. 4. The requirements expressed in paragraph 3 shall not preclude that reporting lines converge at the highest level of an organisation that subsumes different functions or authorities, or that, staff may, under predefined conditions, be shared between the other functions entrusted to the resolution authority to meet temporarily high workloads, or for the resolution authority to be able to avail itself of the expertise of shared staff. 5. Authorities exercising supervision and resolution functions under Regulation (EU) No 648/2012 and this Regulation, and persons exercising those functions on their behalf, shall cooperate closely in the preparation, planning and application of resolution decisions, both where the resolution authority and the competent authority are separate entities and where the functions are carried out by the same entity. 6. Resolution authorities shall adopt and make public the internal rules they have in place to ensure compliance with the requirements set out in paragraph 3, including rules regarding professional secrecy and information exchanges between the different functional areas. 7. Member States where no CCP has been established may derogate from the requirements set out in paragraph 3, except with regards to arrangements to avoid conflicts of interest. 8. Each Member State shall designate a single ministry which shall be responsible for exercising the functions entrusted to the competent ministry pursuant to this Regulation. 9. Where the resolution authority in a Member State is not the competent ministry, the resolution authority shall inform the competent ministry without undue delay of the decisions taken pursuant to this Regulation and, unless otherwise laid down in national law, obtain its approval before implementing decisions that will have a direct fiscal impact or systemic implications that are likely to lead to a direct fiscal impact. 10. Member States shall notify the Commission and the European Supervisory Authority (European Securities and Markets Authority) (ESMA), established by Regulation (EU) No 1095/2010, of the resolution authorities designated pursuant to paragraph 1. 11. Where a Member State designates more than one resolution authority pursuant to paragraph 1, the notification referred to in paragraph 10 shall include the following: (a) the reasons justifying that multiple designation; (b) the allocation of functions and responsibilities between those authorities; (c) the way in which coordination between them is ensured; and (d) the resolution authority designated as the contact authority for the purposes of cooperation and coordination with the relevant authorities of other Member States. 12. ESMA shall publish a list of the resolution authorities and the contact authorities notified pursuant to paragraph 10. Article 4 Resolution colleges 1. The resolution authority of the CCP shall establish, manage and chair a resolution college to carry out the tasks referred to in Articles 12, 15 and 16, and ensure cooperation and coordination with the authorities that are members of the resolution college and, where appropriate, cooperation with third-country competent authorities and resolution authorities. Resolution colleges shall provide a framework for resolution authorities and other relevant authorities to perform the following tasks: (a) exchange information relevant for drawing up resolution plans, including for taking into consideration the systemic impact of the implementation of the resolution plan, for the application of preparatory and preventative measures and for resolution; (b) draw up resolution plans pursuant to Article 12; (c) assess the resolvability of CCPs pursuant to Article 15; (d) identify, address and remove impediments to the resolvability of CCPs pursuant to Article 16; and (e) coordinate public communication about resolution plans and strategies. 2. The following shall be members of the resolution college: (a) the resolution authority of the CCP; (b) the competent authority of the CCP; (c) the competent authorities and the resolution authorities of the clearing members referred to in point (c) of Article 18(2) of Regulation (EU) No 648/2012, including, where relevant, the European Central Bank (ECB) in the framework of the tasks concerning the prudential supervision of credit institutions within the single supervisory mechanism conferred upon it in accordance with Council Regulation (EU) No 1024/2013 (22) and the Single Resolution Board (SRB) in its role as a resolution authority of credit institutions within the single resolution mechanism conferred upon it in accordance with Regulation (EU) No 806/2014; (d) the competent authorities and the resolution authorities of clearing members, other than those referred to in point (c). Those competent authorities and resolution authorities shall inform the resolution authority of the CCP and justify their participation in the college based on their assessment of the impact that the CCP’s resolution could have on the financial stability of their respective Member State; (e) the competent authorities or the resolution authorities of clearing members’ clients, provided that the college does not already have a member from their own Member State in accordance with points (c), (d), (f), (g) or (h). Those authorities shall inform the resolution authority of the CCP and justify their participation in the college based on their assessment of the impact that the CCP’s resolution could have on the financial stability of their respective Member State; (f) the competent authorities referred to in point (d) of Article 18(2) of Regulation (EU) No 648/2012; (g) the competent authorities and the resolution authorities of the CCPs referred to in point (e) of Article 18(2) of Regulation (EU) No 648/2012; (h) the competent authorities referred to in point (f) of Article 18(2) of Regulation (EU) No 648/2012; (i) the members of the European System of Central Banks (ESCB) referred to in point (g) of Article 18(2) of Regulation (EU) No 648/2012; (j) the central banks of issue referred to in point (h) of Article 18(2) of Regulation (EU) No 648/2012; (k) the central banks of issue of the Union currencies of the financial instruments cleared by the CCP, other than those referred to in point (j). Those central banks of issue shall inform the resolution authority of the CCP and justify their participation in the college based on their assessment of the impact that the CCP’s resolution could have on their respective currency of issue; (l) the competent authority of the parent undertaking, where applicable; (m) the competent ministry, where the resolution authority referred to in point (a) is not the competent ministry; (n) ESMA; and (o) the European Supervisory Authority (European Banking Authority) (EBA), established by Regulation (EU) No 1093/2010. 3. ESMA, EBA and the authorities referred to in points (d), (e), (k) and (l) of paragraph 2 shall not have voting rights in resolution colleges. Where the ECB is a member of the college pursuant to points (c) and (j) of paragraph 2, it shall have two votes in the college. 4. The competent authorities and resolution authorities of clearing members established in third countries and the competent authorities and resolution authorities of third-country CCPs with which the CCP has established interoperability arrangements may be invited to participate in the resolution college as observers. Their attendance shall be conditional on those authorities being subject to confidentiality requirements equivalent, in the opinion of the resolution authority of the CCP as the chair of the resolution college, to those laid down in Article 73. The participation of third-country authorities in the resolution college may be limited to the discussion of select cross-border enforcement issues, which may include the following: (a) effective and coordinated enforcement of resolution actions, in particular in accordance with Articles 53 and 77; (b) identification and removal of possible impediments to effective resolution action that may stem from divergent laws governing collateral, netting and set-off arrangements and different recovery and resolution powers or strategies; (c) identification and coordination of any need for new licensing, recognition or authorisation requirements, considering the need for resolution actions to be carried out in a timely fashion; (d) possible suspension of any clearing obligation for the relevant asset classes affected by the resolution of the CCP pursuant to Article 6a of Regulation (EU) No 648/2012 or to any equivalent provision under the national law of the third country concerned; (e) possible influence of different time-zones on the applicable close of business hours regarding the end of trading. 5. The resolution authority of the CCP as the chair of the resolution college shall be responsible for the following tasks: (a) establishing written arrangements and procedures for the functioning of the resolution college, after consulting the other members of the resolution college; (b) coordinating all activities of the resolution college; (c) convening and chairing all meetings of the resolution college; (d) keeping all members of the resolution college fully informed in advance of the organisation of meetings, of the main issues to be discussed in those meetings and of the items to be considered for the purposes of those discussions; (e) deciding whether and which third-country authorities are invited to attend particular meetings of the resolution college in accordance with paragraph 4; (f) enabling, promoting and coordinating the timely exchange of all relevant information between members of the resolution college; and (g) keeping all members of the resolution college informed, in a timely manner, of the decisions and outcomes of those meetings. 6. In order to facilitate the performance of the tasks assigned to the college, members of the college referred to in paragraph 2 shall be entitled to contribute to the setting of the agenda of the college meetings, in particular by adding points to the agenda of the meeting. 7. In order to ensure the consistent and coherent functioning of resolution colleges across the Union, ESMA shall develop draft regulatory technical standards in order to specify the content of the written arrangements and procedures for the functioning of the resolution colleges referred to in paragraph 1. For the purposes of preparing those regulatory standards, ESMA shall take into account the relevant provisions of the delegated acts adopted on the basis of Article 88(7) of Directive 2014/59/EU. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 5 ESMA Resolution Committee 1. ESMA shall create a resolution committee (the ‘ESMA Resolution Committee’) pursuant to Article 41 of Regulation (EU) No 1095/2010 for the purpose of preparing the decisions entrusted to ESMA in this Regulation, except for the decisions to be adopted pursuant to Article 11 of this Regulation. The ESMA Resolution Committee shall also promote the drawing up and coordination of resolution plans and develop methods for the resolution of failing CCPs. 2. The ESMA Resolution Committee shall be composed of the authorities designated pursuant to Article 3(1). Authorities referred to in points (i) and (v) of Article 4(2) of Regulation (EU) No 1093/2010 shall be invited to participate in the ESMA Resolution Committee as observers. 3. For the purposes of this Regulation, ESMA shall cooperate with the European Supervisory Authority (European Insurance and Occupational Pensions Authority) (EIOPA) established by Regulation (EU) No 1094/2010 of the European Parliament and of the Council (23) and EBA within the framework of the Joint Committee of the European Supervisory Authorities established under Article 54 of Regulation (EU) No 1093/2010, Article 54 of Regulation (EU) No 1094/2010 and Article 54 of Regulation (EU) No 1095/2010. 4. For the purposes of this Regulation, ESMA shall ensure structural separation between the ESMA Resolution Committee and other functions referred to in Regulation (EU) No 1095/2010. Article 6 Cooperation between authorities 1. Competent authorities, resolution authorities and ESMA shall cooperate closely for the purposes of this Regulation. In particular, during the recovery phase, the competent authority and the members of the supervisory college should cooperate and communicate effectively with the resolution authority, to enable the resolution authority to act in a timely manner. 2. The resolution authority of a CCP and the resolution authorities of its clearing members shall cooperate closely with the aim of ensuring that there are no impediments to resolution. 3. Competent authorities and resolution authorities shall cooperate with ESMA for the purposes of this Regulation in accordance with Regulation (EU) No 1095/2010. Competent authorities and resolution authorities shall, without delay, provide ESMA with all the information necessary to carry out its duties in accordance with Article 35 of Regulation (EU) No 1095/2010. Section 2 Decision-making and procedures Article 7 General principles regarding decision-making Competent authorities, resolution authorities and ESMA shall take account of all the following principles and aspects when making decisions and taking action pursuant to this Regulation: (a) the effectiveness and proportionality of any decision or action in relation to an individual CCP are ensured, taking into account at least the following factors: (i) the CCP’s legal form, ownership and organisational structure, including, where applicable, any interdependencies within the group to which the CCP belongs; (ii) the nature, size and complexity of the CCP’s business, in particular the size, structure and liquidity in stressed conditions of the markets it serves; (iii) the structure, nature and diversity of the CCP’s clearing membership, as well as, to the extent the information is available, of its clearing members’ network of clients and indirect clients; (iv) the substitutability of the CCP’s critical functions in the markets it serves; (v) the CCP’s interconnectedness with other FMIs, trading venues, financial institutions and with the financial system in general; (vi) whether the CCP clears any OTC derivative contract pertaining to a class of OTC derivatives that has been declared subject to the clearing obligation in accordance with Article 5(2) of Regulation (EU) No 648/2012; and (vii) the actual or potential consequences of the infringements referred to in Articles 18(1) and 22(2). (b) the imperatives of efficacy, of timeliness, of due urgency of decision-making, when required, and of keeping costs as low as possible are observed when decisions are made and action is taken, while at the same time ensuring that market disruption is mitigated to the greatest extent possible; (c) the use of extraordinary public financial support is avoided to the greatest extent possible, such support is available and used only as a last resort and in accordance with the conditions laid out in Article 45, and no expectation of public financial support is created; (d) resolution authorities, competent authorities and other authorities cooperate with each other to ensure that decisions are made and action is taken in a coordinated and efficient manner; (e) the roles and responsibilities of relevant authorities within each Member State are defined clearly; (f) the interests of the Member States where the CCP provides services and where its clearing members, and to the extent the information is available, their clients and indirect clients, including where those clients or indirect clients are designated by Member States as O-SIIs, and any linked FMIs, including interoperable CCPs, are established, and in particular the impact of any decision or action or inaction on the financial stability or fiscal resources of those Member States and the Union as a whole; (g) resolution authorities and resolution colleges cannot require Member States to provide extraordinary public financial support, nor impinge on the budgetary sovereignty and fiscal responsibilities of Member States; (h) the interests of affected clearing members, and to the extent the information is available, their clients and indirect clients, creditors and other stakeholders of the CCP in the Member States involved need to be balanced by avoiding unfairly prejudicing or unfairly protecting the interests of particular actors and avoiding unfair burden allocation within and across Member States; (i) any obligation under this Regulation to consult an authority before any decision or action is taken implies at least an obligation to consult on those elements of the proposed decision or action which have or which are likely to have an effect on the clearing members, clients, linked FMIs or trading venues or an impact on the financial stability of the Member State where the clearing members, clients, linked FMIs or trading venues are established or located; (j) where an authority raises an issue concerning the financial stability of its Member State, the resolution authority and the resolution college of the CCP consider it thoroughly and if they do not take the concerns expressed into account, explain in writing the reasons for not doing so; (k) resolution plans referred to in Article 12 are complied with unless, taking into account the circumstances of the case, deviation from those plans is necessary in order to better achieve the resolution objectives; (l) transparency is ensured towards the relevant authorities wherever possible, and in any case where a proposed decision or action is likely to have implications on the financial stability or fiscal resources of any relevant Member State; (m) they coordinate and cooperate as closely as possible, also with the goal to lower the overall cost of resolution; and (n) the following are kept to a minimum, to the extent possible: negative economic and social effects, including negative impacts on financial stability, of any decision on all the Member States where the CCP provides services and where its clearing members, and to the extent the information is available, their clients and indirect clients, including where those clients or indirect clients are designated by Member States as O-SIIs, and any linked FMIs, including interoperable CCPs, are established. Article 8 Information exchange 1. Resolution authorities, competent authorities and ESMA shall, on their own initiative or on request, provide each other in a timely manner with all the information relevant for the exercise of their tasks under this Regulation. 2. By way of derogation from paragraph 1, the resolution authorities shall only divulge confidential information provided by a third-country authority where that authority has given its prior written consent. 3. Resolution authorities shall provide the competent ministry with all information relating to decisions or measures that require notification, consultation or consent of that ministry. TITLE III PREPARATION CHAPTER I Recovery and resolution planning Section 1 Recovery planning Article 9 Recovery plans 1. CCPs shall draw up and maintain a recovery plan providing for measures to be taken in the case of both default and non-default events and combinations of both, in order to restore their financial soundness, without any extraordinary public financial support, and allow them to continue to provide critical functions following a significant deterioration of their financial situation or a risk of breaching their capital and prudential requirements under Regulation (EU) No 648/2012. 2. The measures included in the recovery plan shall: (a) comprehensively and effectively address all the risks identified in the different scenarios, including possible uncovered liquidity shortfalls; (b) in the case of losses due to a default event, ensure the re-establishment of a matched book and the full allocation of uncovered losses to clearing members, and to their clients if those clients are direct creditors of the CCP, and to shareholders, taking into account the interests of all stakeholders; (c) include loss-absorbing arrangements that are adequate to cover the losses that might arise from all types of non-default events; and (d) enable the replenishment of the CCP’s financial resources, including its own funds, to a level sufficient in order for the CCP to meet its obligations under Regulation (EU) No 648/2012 and to support the continued and timely operation of the critical functions of the CCP. 3. The recovery plan shall include a framework of indicators based on the risk profile of the CCP, that identify the circumstances under which measures in the recovery plan are to be taken. The indicators may be of either a qualitative or a quantitative nature relating to the financial soundness and operational viability of the CCP and should enable recovery measures to be taken early enough to provide sufficient time for the plan to be implemented. 4. CCPs shall put in place appropriate arrangements for the regular monitoring of the indicators referred to in paragraph 3. CCPs shall report to their competent authorities on the outcome of that monitoring. Competent authorities shall transmit information to the supervisory college, where they deem such information significant. 5. ESMA shall, in cooperation with the ESRB, by 12 February 2022, issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010 to specify the minimum list of qualitative and quantitative indicators referred to in paragraph 3 of this Article. 6. CCPs shall include provisions in their operating rules, outlining the procedures to be followed by them where, in order to achieve the goals of the recovery process, they propose to: (a) take measures provided for in their recovery plan despite the fact that the relevant indicators have not been met; or (b) refrain from taking measures provided for in their recovery plan despite the fact that the relevant indicators have been met. Any decision taken pursuant to this paragraph and its justification shall be notified to the competent authority without delay. 7. Where a CCP intends to activate its recovery plan, it shall notify the competent authority of the nature and magnitude of the problems it has identified, setting out all relevant circumstances and indicating the recovery measures or other measures it intends to take to address the situation as well as the envisaged time-frame to restore its financial soundness by use of those measures. Where the competent authority considers that a recovery measure that the CCP intends to take may cause significant adverse effects to the financial system or is unlikely to be effective, it may require the CCP to refrain from taking that measure. Following the notification received under the second subparagraph of paragraph 6 of this Article, the competent authority shall immediately assess whether the circumstances require the use of early intervention powers in accordance with Article 18. 8. The competent authority shall promptly inform the resolution authority and the supervisory college, and the resolution authority shall promptly inform the resolution college, of any notification received in accordance with the second subparagraph of paragraph 6 and with the first subparagraph of paragraph 7, and of any subsequent instruction by the competent authority in accordance with the second subparagraph of paragraph 7. Where the competent authority is informed in accordance with the first subparagraph of paragraph 7 of this Article, it shall restrict or prohibit any remuneration of equity and instruments treated as equity, including dividend payments and buybacks by the CCP, to the fullest extent possible without triggering an event of default, and it may restrict or prohibit any payments of variable remuneration as defined by the CCP’s remuneration policy pursuant to Article 26(5) of Regulation (EU) No 648/2012, discretionary pension benefits or severance packages to senior management as defined in point 29 of Article 2 of Regulation (EU) No 648/2012. 9. CCPs shall, at least annually and in any case after any change to their legal or organisational structure or business or financial situation which could have a material effect on those plans or otherwise necessitate a change to the plans, review, test and, where necessary, update their recovery plans. Competent authorities may require CCPs to update their recovery plans more frequently. 10. Recovery plans shall be drawn up in accordance with Section A of the Annex and take into account all relevant interdependencies within the group to which the CCP belongs. Competent authorities may require CCPs to include additional information in their recovery plans. Where relevant, the competent authority of the CCP shall consult the competent authority of the CCP’s parent undertaking. 11. Recovery plans shall: (a) not assume any access to or receipt of extraordinary public financial support, central bank emergency liquidity assistance or central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms; (b) consider the interests of all stakeholders that are likely to be affected by the plan, including clearing members and, to the extent that the information is available, their direct and indirect clients; and (c) ensure that clearing members do not have unlimited exposures toward the CCP and stakeholders’ potential losses and liquidity shortfalls are transparent, measurable, manageable and controllable. 12. ESMA shall, in cooperation with the ESRB, by 12 February 2022 issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010 further specifying the range of scenarios to be considered for the purposes of paragraph 1 of this Article. In issuing such guidelines, ESMA shall take into account, where appropriate, supervisory stress testing exercises. 13. Where the CCP is part of a group and contractual parental or group support agreements form part of the recovery plan, the recovery plan shall contemplate scenarios in which those agreements cannot be honoured. 14. Following a default or a non-default event, a CCP shall use an additional amount of its pre-funded dedicated own resources, prior to the use of the arrangements and measures referred to in point 15 of Section A of the Annex to this Regulation. That amount shall not be lower than 10 % nor higher than 25 % of the risk-based capital requirements calculated in accordance with Article 16(2) of Regulation (EU) No 648/2012. To comply with that requirement, the CCP may use the amount of capital it holds, in addition to its minimum capital requirements, to comply with the notification threshold referred to in the delegated act adopted on the basis of Article 16(3) of Regulation (EU) No 648/2012. 15. ESMA shall, in close cooperation with EBA and after consulting the ESCB, develop draft regulatory technical standards specifying the methodology for calculation and maintenance of the additional amount of pre-funded dedicated own resources to be used in accordance with paragraph 14. When developing those technical standards, ESMA shall take into account all of the following: (a) the structure and the internal organisation of CCPs and the nature, scope and complexity of their activities; (b) the structure of incentives of the shareholders, management and clearing members of CCPs and of the clients of clearing members; (c) the appropriateness for CCPs, depending on the currencies in which the financial instruments they clear are denominated, the currencies accepted as collateral and the risk stemming from their activities, in particular where they do not clear OTC derivatives as defined in point (7) of Article 2 of Regulation (EU) No 648/2012, to invest that additional amount of dedicated own resources in assets other than those referred to in Article 47(1) of that Regulation; and (d) the rules applying to and the practices of third-country CCPs, as well as the international developments concerning the recovery and resolution of CCPs, in order to preserve the competitiveness of internationally active Union CCPs, and the competitiveness of Union CCPs compared to third-country CCPs providing clearing services in the Union. Where ESMA concludes, on the basis of the criteria referred to in point (c) of the first subparagraph, that it is appropriate for certain CCPs to invest that additional amount of pre-funded dedicated own resources in assets other than those referred to in Article 47(1) of Regulation (EU) No 648/2012, it shall also specify: (a) the procedure through which, in the event that those resources are not immediately available, CCPs may resort to recovery measures that require the financial contribution of non-defaulting clearing members; (b) the procedure that CCPs shall follow to subsequently reimburse the non-defaulting clearing members referred to in point (a) up to the amount to be used in accordance with paragraph 14 of this Article. ESMA shall submit the draft regulatory technical standards referred to in the first subparagraph to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 16. The CCP shall develop adequate mechanisms to involve linked FMIs and stakeholders which would bear losses, incur costs or contribute to cover liquidity shortfalls in the event that the recovery plan was implemented in the process of drawing-up of that plan. 17. The board of the CCP shall assess, taking into account the advice of the risk committee in accordance with Article 28(3) of Regulation (EU) No 648/2012, and approve the recovery plan before submitting it to the competent authority. 18. Where the board of the CCP has decided not to follow the advice of the risk committee, it shall promptly inform the competent authority in accordance with Article 28(5) of Regulation (EU) No 648/2012 and explain its decision in detail to the competent authority. 19. Recovery plans shall be integrated in the corporate governance and the overall risk management framework of the CCP. 20. The measures set out in the recovery plans that create financial or contractual obligations on clearing members and, where relevant, clients and indirect clients, linked FMIs or trading venues shall form part of the operating rules of CCPs. 21. CCPs shall ensure that the measures set out in the recovery plans are enforceable at all times in all jurisdictions where the clearing members, linked FMIs or trading venues are located. 22. The obligation of CCPs to include in their recovery plans the right to make a recovery cash call and, if applicable, to reduce the value of any gains payable by the CCPs to non-defaulting clearing members shall not be applicable to the entities referred to in Articles 1(4) and 1(5) of Regulation (EU) No 648/2012. 23. Clearing members shall communicate to their clients in a clear and transparent manner if and in what way measures in the CCP’s recovery plan may affect them. Article 10 Assessment of recovery plans 1. CCPs shall submit their recovery plans to the competent authority. 2. The competent authority shall transmit each plan to the supervisory college and to the resolution authority without undue delay. The competent authority shall review the recovery plan and assess the extent to which it satisfies the requirements set out in Article 9 within six months of the submission of the plan and in coordination with the supervisory college in accordance with the procedure in Article 11. 3. When assessing the recovery plan, the competent authority and the supervisory college shall take into consideration the following factors: (a) the CCP’s capital structure, its default waterfall, the level of complexity of the organisational structure, the substitutability of its activities and the risk profile of the CCP, including in terms of financial, operational and cyber risks; (b) the overall impact that the implementation of the recovery plan would have on: (i) clearing members, and to the extent the information is available, their clients and indirect clients, including where they have been designated as O-SIIs; (ii) any linked FMIs; (iii) financial markets, including trading venues, served by the CCP; and (iv) the financial system of any Member State and the Union as a whole; (c) whether the recovery tools and their sequence specified by the recovery plan create appropriate incentives for the CCP’s owners, clearing members, and where possible their clients, as relevant, to control the amount of risk that they bring to or incur in the system, monitor the CCP’s risk-taking and risk management activities and contribute to the CCP’s default management process. 4. When assessing the recovery plan, the competent authority shall take parental support agreements into consideration as valid parts of the recovery plan only where those agreements are contractually binding. 5. The resolution authority shall examine the recovery plan in order to identify any measures which may adversely impact the resolvability of the CCP. Where any such measures are identified, the resolution authority shall bring them to the attention of the competent authority and make recommendations to the competent authority on ways to address the adverse impact of those measures on the resolvability of the CCP, within two months of the transmission of each recovery plan by the competent authority. 6. Where the competent authority decides not to act on the recommendations of the resolution authority pursuant to paragraph 5, it shall fully justify that decision to the resolution authority. 7. Where the competent authority agrees with the recommendations of the resolution authority, or considers in coordination with the supervisory college in accordance with Article 11 that there are material deficiencies in the recovery plan or material impediments to its implementation, it shall notify the CCP and shall give it the opportunity to submit its views. 8. The competent authority, taking into account the CCP’s views, may require the CCP to submit, within two months, extendable by one month with the competent authority’s approval, a revised plan demonstrating how those deficiencies or impediments are addressed. The revised plan shall be assessed in accordance with paragraphs 2 to 7. 9. Where the competent authority, after consulting the resolution authority and in coordination with the supervisory college in accordance with the procedure set out in Article 11, considers that the deficiencies and impediments have not been adequately addressed by the revised plan, or where the CCP has not submitted a revised plan, it shall require the CCP to make specific changes to the plan within a reasonable period, as defined by the competent authority. 10. Where it is not possible to adequately remedy the deficiencies or impediments through specific changes to the plan, the competent authority, after consulting the resolution authority and in coordination with the supervisory college in accordance with the procedure set out in Article 11, shall require the CCP to identify within a reasonable timeframe any changes to be made to its business in order to address the deficiencies in or impediments to the implementation of the recovery plan. Where the CCP fails to identify such changes within the timeframe set by the competent authority, or where the competent authority, after consulting the resolution authority and in coordination with the supervisory college in accordance with the procedures set out in Article 11, considers that the actions proposed would not adequately address the deficiencies or impediments to the implementation of the recovery plan, the competent authority shall require the CCP to take within a reasonable period, as defined by the competent authority, specified actions with regard to one or more of the following objectives, taking into account the seriousness of the deficiencies and impediments and the effect of the measures on the CCP’s business and ability to remain in compliance with Regulation (EU) No 648/2012: (a) to reduce the risk profile of the CCP; (b) to enhance the CCP’s ability to be recapitalised in a timely manner to meet its capital and prudential requirements; (c) to review the CCP’s strategy and structure; (d) to make changes to the default waterfall, recovery measures and other loss allocation arrangements so as to improve resolvability and the resilience of critical functions; (e) to make changes to the governance structure of the CCP. 11. The request referred to in the second subparagraph of paragraph 10 shall be reasoned and notified in writing to the CCP. 12. ESMA, in cooperation with the ESCB and the ESRB, shall develop draft regulatory technical standards further specifying the factors referred to in points (a), (b) and (c) of paragraph 3. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 11 Coordination procedure for recovery plans 1. The supervisory college shall examine the recovery plan and, where any member of the college considers that there are material deficiencies in the recovery plan or any material impediment to its implementation, that member shall make recommendations to the competent authority of the CCP with regard to those matters within two months of the transmission of the recovery plan by the competent authority. 2. The supervisory college shall reach a joint decision on all of the following issues: (a) the review and assessment of the recovery plan; (b) the application of the measures referred to in Article 10(7), (8), (9) and (10). 3. The supervisory college shall reach a joint decision on the issues referred to in paragraph 2 within four months of the date of the transmission of the recovery plan by the competent authority. ESMA may, at the request of a competent authority within the supervisory college, assist the supervisory college in reaching a joint decision in accordance with point (c) of Article 31(2) of Regulation (EU) No 1095/2010. 4. Where, after four months from the date of transmission of the recovery plan, the college has failed to reach a joint decision on the issues referred to in paragraph 2, the competent authority of the CCP shall make its own decision. The competent authority of the CCP shall make the decision referred to in the first subparagraph taking into account the views of the other college members expressed during the four-month period. The competent authority of the CCP shall notify in writing that decision to the CCP and to the other members of the college. 5. Where, by the end of that four-month period, a joint decision has not been reached and a simple majority of the voting members disagree with the competent authority’s proposal for a joint decision on a matter in relation to the assessment of recovery plans or implementation of the measures pursuant to points (a), (b) and (d) of Article 10(10) of this Regulation, any of the voting members concerned, based on that majority, may refer that matter to ESMA in accordance with Article 19 of Regulation (EU) No 1095/2010. The competent authority of the CCP shall await the decision taken by ESMA in accordance with Article 19(3) of Regulation (EU) No 1095/2010 and decide in accordance with the decision of ESMA. 6. The four-month period shall be deemed to be the conciliation phase within the meaning of Regulation (EU) No 1095/2010. ESMA shall take its decision within one month of the referral of the matter to it. The matter shall not be referred to ESMA after the end of the four-month period or after a joint decision has been reached. In the absence of an ESMA decision within one month, the decision of the competent authority of the CCP shall apply. Section 2 Resolution planning Article 12 Resolution plans 1. The resolution authority of the CCP shall, after consultation with the competent authority and in coordination with the resolution college, in accordance with the procedure set out in Article 14, draw up a resolution plan for the CCP. 2. The resolution plan shall provide for the resolution actions that the resolution authority may take where the CCP meets the conditions for resolution referred to in Article 22. 3. The resolution plan shall take into consideration at least the following: (a) the CCP’s failure, including in situations of broader financial instability or system wide events, due to one of the following or their combination: (i) default events, and (ii) non-default events; (b) the impact that the implementation of the resolution plan would have on: (i) the clearing members, and to the extent the information is available, their clients and indirect clients, including where they have been designated as O-SIIs and those likely to be subject to recovery measures or resolution actions in accordance with Directive 2014/59/EU; (ii) any linked FMIs; (iii) financial markets, including trading venues, served by the CCP; and (iv) the financial system in any Member State or the Union as a whole, and, to the extent possible, in third countries where it provides services; (c) the manner and the circumstances under which a CCP may apply for the use of central bank facilities provided under standard collateralisation, tenor and interest rate terms and the identification of the assets that would be expected to qualify as collateral. 4. The resolution plan shall not assume any of the following: (a) extraordinary public financial support; (b) central bank emergency liquidity assistance; (c) central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms. 5. The resolution plan shall make prudent assumptions regarding the financial resources available as resolution tools that may be required to achieve the resolution objectives and the resources that are expected to be available in accordance with the CCP’s rules and arrangements at the time of entering into resolution. Those prudent assumptions shall take into account the relevant findings of latest stress tests carried out in accordance with Article 32(2) of Regulation (EU) No 1095/2010, specified in point (b) of Article 24a(7) of Regulation (EU) No 648/2012, as well as scenarios of extreme market conditions beyond those in the CCP’s recovery plan. 6. The resolution authority of a CCP shall, after consultation with the competent authority and in coordination with the resolution college in accordance with the procedure in Article 14, review resolution plans and where appropriate update them, at least annually and in any case after changes to the legal or organisational structure of the CCP, its business or financial situation or any other change that materially affects the effectiveness of the plan. The CCP and the competent authority shall promptly inform the resolution authority of any such change. 7. The resolution plan shall specify the circumstances and different scenarios for applying the resolution tools and exercising the resolution powers. It shall clearly distinguish, in particular through different scenarios, between failure caused by default events, non-default events, and a combination of both, as well as between different types of non-default events. The resolution plan shall include the following, quantified whenever appropriate and possible: (a) a summary of the key elements of the plan, distinguishing between default events, non-default events and a combination of the two; (b) a summary of the material changes to the CCP that have occurred since the resolution plan was last updated; (c) a description of how the CCP’s critical functions could be legally and economically separated, to the extent necessary, from its other functions so as to ensure the continuity of its critical functions in the resolution of the CCP; (d) an estimation of the timeframe for implementing each material aspect of the plan, including for replenishing the CCP’s financial resources; (e) a detailed description of the assessment of resolvability carried out in accordance with Article 15; (f) a description of any measures required pursuant to Article 16 to address or remove impediments to resolvability identified as a result of the assessment carried out in accordance with Article 15; (g) a description of the processes for determining the value and marketability of the critical functions and assets of the CCP; (h) a detailed description of the arrangements for ensuring that the information required pursuant to Article 13 is up to date and available to the resolution authorities at all times; (i) an explanation as to how resolution actions could be financed without the assumption of the elements referred to in paragraph 4; (j) a detailed description of the different resolution strategies that could be applied according to the different possible scenarios and their related timeframes; (k) a description of critical interdependencies between the CCP and other market participants and between the CCP and critical service providers, interoperability arrangements and links with other FMIs, as well as ways to address all of those interdependencies; (l) a description of critical intra-group interdependencies as well as ways to address them; (m) a description of the different options to ensure: (i) access to payments and clearing services and other infrastructures; (ii) timely settlement of obligations due to clearing members and, where applicable, their clients and any linked FMIs; (iii) access of clearing members, and, where applicable, their clients on a transparent and non-discriminatory basis to securities or cash accounts provided by the CCP and securities or cash collateral posted to and held by the CCP that is owed to such participants; (iv) continuity in the operations of links between the CCP and other FMIs and between the CCP and trading venues; (v) preservation of the portability of the positions and related assets of direct and indirect clients; and (vi) preservation of the licenses, authorisations, recognitions and legal designations of a CCP where necessary for the continued performance of the CCP’s critical functions including its recognition for the purposes of the application of the relevant settlement finality rules and the participation in or links with other FMIs or with trading venues; (n) a description of how the resolution authority will obtain the necessary information to perform the valuation referred to in Article 24; (o) an analysis of the impact of the plan on the employees of the CCP, including an assessment of any associated costs, and a description of envisaged procedures to consult with staff during the resolution process, taking into account any national rules and systems for dialogue with social partners; (p) a plan for communicating with the media and the public so as to be as transparent as possible; (q) a description of essential operations and systems for maintaining the continuous functioning of the CCP’s operational processes; (r) a description of the arrangements for notifying the resolution college in accordance with Article 72(1); (s) a description of the measures to facilitate the portability of positions and related assets of the clearing members and clients of the defaulting CCP from the defaulting CCP to another CCP or a bridge CCP while not affecting the contractual relationships between the clearing members and their clients. 8. The information referred to in point (a) of paragraph 7 shall be disclosed to the CCP concerned. The CCP may express its opinion in writing on the resolution plan to the resolution authority. That opinion shall be included in the plan. 9. ESMA, after consulting the ESRB and taking into account the relevant provisions of the delegated acts adopted on the basis of Article 10(9) of Directive 2014/59/EU and respecting the principle of proportionality shall develop draft regulatory technical standards further specifying the contents of the resolution plan in accordance with paragraph 7 of this Article. When developing the draft regulatory technical standards, ESMA shall enable sufficient flexibility for resolution authorities to take into consideration the specificities of their national legal framework in the area of insolvency law, as well as the nature and complexity of the clearing business performed by the CCPs. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 13 CCPs’ duty to cooperate and provide information 1. CCPs shall cooperate as necessary in the drawing up of resolution plans and provide their resolution authority, either directly or through their competent authority, with all the information necessary to draw up and implement those plans, including the information and analysis specified in Section B of the Annex. Competent authorities shall provide resolution authorities with any information referred to in the first subparagraph which is already available to them. 2. Resolution authorities may require CCPs to provide them with detailed records of the contracts referred to in Article 29 of Regulation (EU) No 648/2012 to which they are a party. Resolution authorities may specify a time limit to provide those records and may specify different time limits for different types of contracts. 3. A CCP shall exchange information in a timely manner with its competent authorities in order to facilitate the assessment of the risk profiles of the CCP and the interconnectedness with other FMIs, other financial institutions and with the financial system in general as referred to in Articles 9 and 10. Competent authorities shall transmit information to the supervisory college, where they deem such information significant. Article 14 Coordination procedure for resolution plans 1. The resolution authority shall transmit to the resolution college a draft resolution plan, the information provided in accordance with Article 13 and any additional information relevant to the resolution college. 2. The resolution college shall reach a joint decision regarding the resolution plan and any changes thereto within a four-month period from the date of the transmission of that plan by the resolution authority referred to in paragraph 1. The resolution authority shall ensure that ESMA is provided with all the information that is relevant to its role in accordance with this Article. 3. The resolution authority may, in accordance with Article 4(4), decide to involve third-country authorities when drawing up and reviewing the resolution plan, provided that they meet the confidentiality requirements laid down in Article 73 and are from jurisdictions in which any of the following entities are established: (a) the CCP’s parent undertaking, where applicable; (b) the clearing members of the CCP where their contribution to the default fund of the CCP is, on an aggregate basis over a one-year period, higher than those of the third Member State with the largest contributions as referred to in point (c) of Article 18(2) of Regulation (EU) No 648/2012; (c) the CCP’s subsidiaries, where applicable; (d) other providers of critical services to the CCP; (e) interoperable CCPs. 4. ESMA may, at the request of a resolution authority, assist the resolution college in reaching a joint decision in accordance with point (c) of Article 31(2) of Regulation (EU) No 1095/2010. 5. Where, after four months from the date of transmission of the resolution plan, the resolution college has failed to reach a joint decision, the resolution authority shall make its own decision on the resolution plan. The resolution authority shall make its decision taking into account the views of the other resolution college members expressed during the four-month period. The resolution authority shall notify in writing the decision to the CCP and to the other members of the resolution college. 6. Where, by the end of the four-month period referred to in paragraph 5 of this Article, a joint decision has not been reached and a simple majority of the voting members disagree with the resolution authority’s proposal for a joint decision on a matter in relation to the resolution plan, any of the voting members concerned, based on that majority, may refer that matter to ESMA in accordance with Article 19 of Regulation (EU) No 1095/2010. The resolution authority of the CCP shall await the decision taken by ESMA in accordance with Article 19(3) of Regulation (EU) No 1095/2010 and decide in accordance with the decision of ESMA. The four-month period shall be deemed to be the conciliation phase within the meaning of Regulation (EU) No 1095/2010. ESMA shall take its decision within one month of the referral of the matter to it. The matter shall not be referred to ESMA after the end of the four-month period or after a joint decision has been reached. In the absence of an ESMA decision within one month, the decision of the resolution authority shall apply. 7. Where a joint decision is taken pursuant to paragraph 1 and any resolution authority or competent ministry considers under paragraph 6 that the subject matter of the disagreement impinges on the fiscal responsibilities of its Member State, the resolution authority of the CCP shall initiate a reassessment of the resolution plan. CHAPTER II Resolvability Article 15 Assessment of resolvability 1. The resolution authority, in coordination with the resolution college in accordance with the procedure set out in Article 17, and after consultation with the competent authority, shall assess the extent to which a CCP is resolvable without assuming any of the following: (a) extraordinary public financial support; (b) central bank emergency liquidity assistance; (c) central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms. 2. A CCP shall be deemed resolvable where the resolution authority considers it feasible and credible to either liquidate it under normal insolvency proceedings or to resolve it applying the resolution tools and exercising the resolution powers while ensuring the continuity of the CCP’s critical functions and avoiding any use of extraordinary public financial support and, to the maximum extent possible, any significant adverse effect on the financial system and the potential for undue disadvantage to affected stakeholders. The adverse effects referred to in the first subparagraph shall include broader financial instability or system wide events in any Member State. The resolution authority shall notify ESMA in a timely manner where it considers that a CCP is not resolvable. 3. Upon request by the resolution authority, a CCP shall demonstrate that: (a) there are no impediments to the reduction of the value of instruments of ownership following the exercise of resolution powers, regardless of whether outstanding contractual arrangements or other measures in the CCP’s recovery plan have been fully exhausted; and (b) the contracts of the CCP with clearing members or third parties do not enable those clearing members or third parties to successfully challenge the exercise of resolution powers by a resolution authority or otherwise avoid being subject to those powers. 4. For the purposes of the assessment of resolvability referred to in paragraph 1, the resolution authority shall, as relevant, examine the matters specified in Section C of the Annex. 5. By 12 August 2022, ESMA, in close cooperation with the ESRB, shall issue guidelines to promote the convergence of resolution practices regarding the application of Section C of the Annex to this Regulation in accordance with Article 16 of Regulation (EU) No 1095/2010. 6. The resolution authority in coordination with the resolution college shall make the resolvability assessment at the same time as drawing up and updating the resolution plan in accordance with Article 12. Article 16 Addressing or removing impediments to resolvability 1. Where, following the assessment in Article 15, the resolution authority, in coordination with the resolution college in accordance with the procedure set out in Article 17, concludes that there are material impediments to the resolvability of a CCP, the resolution authority, in cooperation with the competent authority, shall prepare and submit a report to the CCP and to the resolution college. The report referred to in the first subparagraph shall analyse the material impediments to the effective application of the resolution tools and the exercise of the resolution powers in relation to the CCP, consider their impact on the business model of the CCP and recommend targeted measures to remove those impediments. 2. The requirement laid down in Article 14 for resolution colleges to reach a joint decision on resolution plans shall be suspended following the submission of the report referred to in paragraph 1 of this Article until the measures to remove the material impediments to resolvability have been accepted by the resolution authority pursuant to paragraph 3 of this Article or alternative measures have been decided pursuant to paragraph 4 of this Article. 3. Within four months of the date of receipt of the report submitted in accordance with paragraph 1 of this Article, the CCP shall propose to the resolution authority possible measures to address or remove the material impediments identified in the report. The resolution authority shall communicate to the resolution college any measure proposed by the CCP. The resolution authority and resolution college shall assess, in accordance with point (b) of Article 17(1), whether those measures effectively address or remove those impediments. 4. Where the resolution authority in coordination with the resolution college in accordance with the procedure set out in Article 17 concludes that the measures proposed by a CCP in accordance with paragraph 3 of this Article would not effectively reduce or remove the impediments identified in the report, the resolution authority shall identify alternative measures which it shall communicate to the resolution college for joint decision in accordance with point (c) of Article 17(1). The alternative measures referred to in the first subparagraph shall take into account the following: (a) the threat to financial stability of those material impediments to the resolvability of a CCP; (b) the likely effect of the alternative measures on: (i) the CCP, including its business model and operational efficiency; (ii) its clearing members, and to the extent the information is available, their clients and indirect clients, including where they have been designated as O-SIIs; (iii) any linked FMIs; (iv) financial markets, including trading venues, served by the CCP; (v) the financial system in any Member State or the Union as a whole; and (vi) the internal market; and (c) the effects on the provision of integrated clearing services for different products and portfolio margining across asset classes. For the purposes of points (a) and (b) of the second subparagraph, the resolution authority shall consult the competent authority and the resolution college and, where appropriate, relevant designated national macroprudential authorities. 5. The resolution authority shall notify the CCP in writing, either directly or indirectly through the competent authority, of the alternative measures to take in order to achieve the objective of removing impediments to resolvability. The resolution authority shall justify why the measures proposed by the CCP would not be able to remove the material impediments to resolvability and how the alternative measures would be effective in doing so. 6. The CCP shall propose within one month a plan to comply with the alternative measures, with a reasonable timeframe for the implementation of the plan. If deemed necessary by the resolution authority, the resolution authority may shorten or extend the proposed timeframe. 7. For the purposes of paragraph 4, the resolution authority may, after consulting the competent authority and while allowing for a reasonable timeframe for implementation: (a) require the CCP to revise or draw up service agreements, whether intra-group or with third parties, to cover the provision of critical functions; (b) require the CCP to limit its maximum individual and aggregate uncovered exposures; (c) require the CCP to make changes to how it collects and holds margins pursuant to Article 41 of Regulation (EU) No 648/2012; (d) require the CCP to make changes to the composition and number of its default funds referred to in Article 42 of Regulation (EU) No 648/2012; (e) impose on the CCP specific or regular additional information requirements; (f) require the CCP to divest specific assets; (g) require the CCP to limit or cease specific existing or proposed activities; (h) require the CCP to make changes to its recovery plan, operating rules and other contractual arrangements; (i) restrict or prevent the development of new or existing business lines or provision of new or existing services; (j) require changes to legal or operational structures of the CCP or any group entity directly or indirectly under its control to ensure that critical functions may be legally and operationally separated from other functions through the application of resolutions tools; (k) require the CCP to operationally and financially segregate its different clearing services so as to isolate some specific asset classes from other asset classes and where deemed appropriate, to restrict netting sets covering different asset classes; (l) require the CCP to set up a parent undertaking in the Union; (m) require the CCP to issue liabilities that can be written down and converted or to set aside other financial resources to increase the capacity for loss absorption, recapitalisation and the replenishment of pre-funded resources; (n) require the CCP to take other steps to enable capital, other liabilities and contracts to be able to absorb losses, to recapitalise the CCP or to replenish pre-funded resources. Actions considered may include in particular attempting to renegotiate any liability the CCP has issued or to revise contractual terms, with a view to ensuring that any decision of the resolution authority to write down, convert or restructure that liability, instrument or contract would be effected under the law of the jurisdiction governing that liability or instrument; (o) where the CCP is a subsidiary, coordinate with relevant authorities with a view to requiring the parent undertaking to set up a separate holding company to control the CCP, where that measure is necessary in order to facilitate the resolution of the CCP and to avoid the adverse effects that the application of the resolution tools and the exercise of the resolution powers could have on other entities of the group; (p) restrict or prohibit interoperability links of the CCP where such a restriction or prohibition is necessary in order to avoid adverse effects on the achievement of resolution objectives. Article 17 Coordination procedure to address or remove impediments to resolvability 1. The resolution college shall reach a joint decision regarding: (a) the identification of the material impediments to resolvability pursuant to Article 15(1); (b) the assessment of the measures proposed by the CCP pursuant to Article 16(3), as necessary; (c) the alternative measures required pursuant to Article 16(4). 2. The joint decision on the identification of material impediments to resolvability referred to in point (a) of paragraph 1 of this Article shall be adopted within four months of the submission of the report referred to in Article 16(1) to the resolution college. 3. The joint decision referred to in point (b) of paragraph 1 of this Article shall be adopted within four months of submission of the CCP’s proposed measures to remove impediments to resolvability as referred to in Article 16(3). 4. The joint decision referred to in point (c) of paragraph 1 of this Article shall be adopted within four months of the communication of the alternative measures to the resolution college as referred to in Article 16(4). 5. The joint decisions referred to in paragraph 1 shall be reasoned and notified in writing by the resolution authority to the CCP and, where the resolution authority deems it relevant, its parent undertaking. 6. ESMA may, at the request of the resolution authority of the CCP, assist the resolution college in reaching a joint decision in accordance with point (c) of Article 31(2) of Regulation (EU) No 1095/2010. 7. Where, after four months from the date of transmission of the report provided for in Article 16(1), the resolution college has failed to adopt a joint decision, the resolution authority shall take its own decision on the appropriate measures to be taken in accordance with Article 16(5). The resolution authority shall take its decision having taken into account the views of the other resolution college members expressed during the four-month period. The resolution authority shall notify the decision to the CCP, to its parent undertaking where relevant, and to the other members of the resolution college in writing. 8. Where, by the end of the four-month period referred to in paragraph 7 of this Article, a joint decision has not been reached and a simple majority of the voting members disagree with the resolution authority’s proposal for a joint decision on a matter referred to in point (j), (l) or (o) of Article 16(7) of this Regulation, any of the voting members concerned, based on that majority, may refer that matter to ESMA in accordance with Article 19 of Regulation (EU) No 1095/2010. The resolution authority of the CCP shall await the decision taken by ESMA in accordance with Article 19(3) of Regulation (EU) No 1095/2010 and decide in accordance with the decision of ESMA. The four-month period shall be deemed to be the conciliation phase within the meaning of Regulation (EU) No 1095/2010. ESMA shall take its decision within one month of the referral of the matter to it. The matter shall not be referred to ESMA after the end of the four-month period or after a joint decision has been reached. In the absence of an ESMA decision within one month, the decision of the resolution authority shall apply. TITLE IV EARLY INTERVENTION Article 18 Early intervention measures 1. Where a CCP infringes, or is likely to infringe in the near future, the capital and prudential requirements of Regulation (EU) No 648/2012, or poses a risk to financial stability in the Union or in one or more of its Member States, or where the competent authority has determined that there are other indications of an emerging crisis situation that could affect the operations of the CCP, in particular, its ability to provide clearing services, the competent authority may: (a) require the CCP to update the recovery plan in accordance with Article 9(6) of this Regulation, where the circumstances that required early intervention are different from the assumptions set out in the initial recovery plan; (b) require the CCP to implement one or more of the arrangements or measures set out in the recovery plan within a specific timeframe. Where the plan is updated pursuant to point (a), those arrangements or measures shall include any updated arrangements or measures; (c) require the CCP to identify the causes of the infringement or likely infringement as mentioned in paragraph 1 and draw up an action programme, including suitable measures and timeframes; (d) require the CCP to convene a meeting of its shareholders or, if the CCP fails to comply with that requirement, convene the meeting itself. In both cases the competent authority shall set the agenda, including the decisions to be considered for adoption by the shareholders; (e) require one or more members of the board or senior management to be removed or replaced where any of those persons is found unfit to perform their duties pursuant to Article 27 of Regulation (EU) No 648/2012; (f) require changes to the business strategy of the CCP; (g) require changes to the legal or operational structures of the CCP; (h) provide the resolution authority with all the information necessary to update the CCP’s resolution plan in order to prepare for the possible resolution of the CCP and the valuation of its assets and liabilities in accordance with Article 24 of this Regulation, including any information acquired through on-site inspections; (i) require, where necessary and in accordance with paragraph 4, the implementation of the CCP’s recovery measures; (j) require the CCP to abstain from the implementation of certain recovery measures where the competent authority has determined that the implementation of those measures may have an adverse effect on financial stability in the Union or in one or more of its Member States; (k) require the CCP to replenish its financial resources in a timely manner in order to comply or maintain compliance with its capital and prudential requirements; (l) require the CCP to instruct clearing members to invite their clients to participate directly in auctions organised by the CCP when the nature of the auction justifies this exceptional participation. Clearing members shall inform their clients comprehensively about the auction following the instructions received from the CCP. In particular, the CCP shall specify the deadline after which it will not be possible to participate in the auction. Clients shall directly inform the CCP before this deadline of their willingness to participate in the auction. The CCP shall then facilitate the bidding process for those clients. A client shall only be authorised to participate in the auction if it is able to demonstrate to the CCP that it has set up the appropriate contractual relationship with a clearing member to execute and clear the transactions that may result from the auction; (m) restrict or prohibit any remuneration of equity and instruments treated as equity to the fullest extent possible without triggering an event of default, including dividend payments and buybacks by the CCP, and it may restrict, prohibit or freeze any payments of variable remuneration as defined by the CCP’s remuneration policy pursuant to Article 26(5) of Regulation (EU) No 648/2012, discretionary pension benefits or severance packages to senior management as defined in point 29 of Article 2 of Regulation (EU) No 648/2012. 2. For each of the measures referred to in paragraph 1, the competent authority shall set an appropriate deadline and evaluate the effectiveness of those measures once they have been taken. 3. The competent authority shall only apply the measures in points (a) to (m) of paragraph 1 after taking account of the impact of those measures in other Member States where the CCP operates or provides services and after informing the relevant competent authorities, in particular where the CCP’s operations are critical or important for local financial markets, including the places in which clearing members, linked trading venues and FMIs are established. 4. The competent authority shall apply the measure in point (i) of paragraph 1 only where that measure is in the public interest and is necessary to achieve any of the following objectives: (a) to maintain the financial stability in the Union or in one or more of its Member States; (b) to maintain the continuity of the critical functions of the CCP and access to critical functions on a transparent and non-discriminatory basis; (c) to maintain or restore the financial resilience of the CCP. The competent authority shall not apply the measure in point (i) of paragraph 1 in relation to measures involving the transfer of property, rights or liabilities of another CCP. 5. Where a CCP uses contributions to the default fund of the non-defaulting clearing members in accordance with Article 45(3) of Regulation (EU) No 648/2012, it shall inform the competent authority and the resolution authority without undue delay and explain whether that event reflects weaknesses or problems of that CCP. 6. Where the conditions referred to in paragraph 1 are met, the competent authority shall notify ESMA and the resolution authority and consult the supervisory college on the envisaged measures provided for in paragraph 1. Following those notifications and the consultation of the supervisory college, the competent authority shall decide whether to apply any of the measures provided for in paragraph 1. The competent authority shall notify the decision on the measures to be taken to the supervisory college, the resolution authority and ESMA. 7. The resolution authority, following the notification of the first subparagraph of paragraph 6 of this Article, may require the CCP to contact potential purchasers in order to prepare for its resolution, subject to the conditions laid down in Article 41 and the confidentiality provisions laid down in Article 73. 8. ESMA shall, by 12 February 2022, issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010 to promote the consistent application of the triggers for the use of the measures referred to in paragraph 1 of this Article. Article 19 Removal of senior management and board 1. Where there is a significant deterioration in the financial situation of a CCP, or the CCP infringes its legal requirements, including its operating rules, and other measures taken in accordance with Article 18 are not sufficient to reverse that situation, competent authorities may require total or partial removal of the senior management or board of the CCP. Where the competent authority requires complete or partial removal of the senior management or board of the CCP, it shall notify ESMA, the resolution authority and the supervisory college. 2. The appointment of the new senior management or board shall be done in accordance with Article 27 of Regulation (EU) No 648/2012 and be subject to the approval or consent of the competent authority. Where the competent authority considers that replacement of the senior management or board as referred to in this Article is insufficient, it may appoint one or more temporary administrators to the CCP to replace or to temporarily work with the board and senior management of the CCP. Any temporary administrator shall have the qualifications, ability and knowledge required to carry out his or her functions and be free of any conflict of interests. Article 20 Provision of recompense to non-defaulting clearing members 1. Without prejudice to the responsibility of clearing members to take losses which go beyond the default waterfall, where a CCP in recovery caused by a non-default event has applied the arrangements and measures to reduce the value of any gains payable by the CCP to non-defaulting clearing members set out in its recovery plan, and as a result has not entered into resolution, the competent authority of the CCP may require the CCP to recompense the clearing members for their loss through cash payments or, where appropriate, may require the CCP to issue instruments recognising a claim on the future profits of the CCP. The possibility to provide recompense to non-defaulting clearing members shall not apply to their contractually committed losses in the default management or recovery phases. The cash payments or the value of instruments recognising a claim on future profits of the CCP issued to each affected non-defaulting clearing member shall be proportionate to its loss in excess of its contractual commitments. The instruments recognising a claim on future profits of the CCP shall entitle the possessor to receive payments from the CCP on an annual basis until the loss has been recouped, if possible in full, subject to an appropriate maximum number of years from the date of issuance. If the non-defaulting clearing members have passed on the excess losses to their clients, the non-defaulting clearing members shall be obliged to pass the payments received by the CCP on to their clients, to the extent that the losses being recompensed are related to client positions. An appropriate maximum share of the CCP’s annual profits shall be used towards payments relating to those instruments. 2. ESMA shall develop draft regulatory technical standards to specify the order in which recompense must be paid, the appropriate maximum number of years and the appropriate maximum share of the CCP’s annual profits referred to in the second subparagraph of paragraph 1. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. TITLE V RESOLUTION CHAPTER I Objectives, conditions and general principles Article 21 Resolution objectives 1. When applying the resolution tools and exercising the resolution powers, the resolution authority shall have regard to all the following resolution objectives, which are of equal significance and shall balance them as appropriate to the nature and circumstances of each case: (a) to ensure the continuity of the CCP’s critical functions, in particular: (i) the timely settlement of the CCP’s obligations to its clearing members and, where applicable, their clients; (ii) continuous access of clearing members and, where applicable, their clients to securities or cash accounts provided by the CCP and collateral in the form of financial assets held by the CCP; (b) to ensure the continuity of the links with other FMIs which, if disrupted, would have a material negative impact on financial stability in the Union or in one or more of its Member States as well as the timely completion of payment, clearing, settlement and record-keeping functions; (c) to avoid a significant adverse effect on the financial system in the Union or in one or more of its Member States, in particular by preventing or mitigating contagion of financial distress to the CCP’s clearing members, their clients or to the wider financial system, including other FMIs, and by maintaining market discipline and public confidence; and (d) to protect public funds by minimising reliance on extraordinary public financial support and the potential risk of losses for taxpayers. 2. When pursuing the objectives set out in paragraph 1, the resolution authority shall seek to minimise the cost of resolution on all affected stakeholders and avoid destruction of the CCP’s value, unless such destruction is necessary to achieve the resolution objectives. Article 22 Conditions for resolution 1. The resolution authority shall take a resolution action in relation to a CCP provided that all of the following conditions are met: (a) the CCP is failing or is likely to fail as determined by any of the following: (i) the competent authority, after consulting the resolution authority; (ii) the resolution authority after consulting the competent authority, where the resolution authority has the necessary tools for reaching that conclusion; (b) there is no reasonable prospect that any alternative private sector measures, including the CCP’s recovery plan or other contractual arrangements, or supervisory action, including early intervention measures taken, would prevent the failure of the CCP within a reasonable timeframe, having regard to all relevant circumstances; (c) a resolution action is necessary in the public interest to achieve, while being proportionate to, one or more of the resolution objectives, and winding up the CCP under normal insolvency procedures would not meet those resolution objectives to the same extent. 2. For the purposes of point (a)(ii) of paragraph 1, the competent authority shall provide the resolution authority on its own initiative and without delay with any information that may give an indication that the CCP is failing or likely to fail. The competent authority shall also provide the resolution authority upon request with any other information needed in order to perform its assessment. 3. For the purposes of point (a) of paragraph 1, a CCP shall be deemed to be failing or likely to fail where one or more of the following circumstances apply: (a) the CCP infringes, or is likely to infringe, its authorisation requirements in a way that would justify the withdrawal of its authorisation pursuant to Article 20 of Regulation (EU) No 648/2012; (b) the CCP is unable, or is likely to be unable, to provide a critical function; (c) the CCP is unable, or is likely to be unable, to restore its viability through the implementation of its recovery measures; (d) the CCP is unable, or is likely to be unable, to pay its debts or other liabilities as they fall due; (e) the CCP requires extraordinary public financial support. 4. For the purposes of point (e) of paragraph 3, public financial support shall not be considered extraordinary public financial support where it meets all of the following conditions: (a) it takes the form of a State guarantee to back liquidity facilities provided by a central bank according to the central bank’s conditions, or the form of a State guarantee of newly issued liabilities; (b) the State guarantees referred to in point (a) of this paragraph are required to remedy a serious disturbance in the economy of a Member State and preserve financial stability; and (c) the State guarantees referred to in point (a) of this paragraph are confined to solvent CCPs, conditional on final approval under the Union State aid framework, are of a precautionary and temporary nature, proportionate to remedy the consequences of the serious disturbance referred to in point (b) of this paragraph and are not used to offset losses that the CCP has incurred or is likely to incur in the future. 5. The resolution authority may also take a resolution action where it considers that the CCP has applied or intends to apply recovery measures which could prevent the CCP’s failure but cause significant adverse effects to the financial system of the Union or of one of more of its Member States. 6. ESMA shall issue guidelines to promote the convergence of supervisory and resolution practices regarding the application of the circumstances under which a CCP is deemed to be failing or likely to fail by 12 February 2022, taking into consideration, as appropriate, the nature, and complexity of the services provided by CCPs established in the Union. When developing those guidelines, ESMA shall take into account the guidelines issued in accordance with Article 32(6) of Directive 2014/59/EU. Article 23 General principles regarding resolution 1. The resolution authority shall take all appropriate measures to apply the resolution tools referred to in Article 27 and exercise the resolution powers referred to in Article 48 in accordance with the following principles: (a) all contractual obligations and other arrangements in the CCP’s recovery plan are enforced, to the extent that they have not been exhausted before entry into resolution, unless the resolution authority determines that in order to achieve the resolution objectives in a timely manner any of the following or both are more appropriate: (i) to refrain from enforcing certain contractual obligations under the CCP’s recovery plan or otherwise deviate from it; (ii) to apply resolution tools or exercise the resolution powers; (b) the shareholders of the CCP under resolution bear first losses following the enforcement of all obligations and arrangements referred to in point (a) and in accordance with that point; (c) creditors of the CCP under resolution bear losses after the shareholders in accordance with the order of priority of their claims under normal insolvency proceedings, unless expressly provided otherwise in this Regulation; (d) the CCP’s creditors of the same class are treated in an equitable manner; (e) the CCP’s shareholders, clearing members and other creditors should not incur greater losses than they would have incurred in the circumstances referred to in Article 60; (f) the board and senior management of the CCP under resolution are replaced, except where the resolution authority considers that the retention of the board and senior management, in whole or in part, is necessary for the achievement of the resolution objectives; (g) resolution authorities inform and consult employee representatives in accordance with their national laws, collective agreements or practice; (h) resolution tools are applied and resolution powers are exercised without prejudice to provisions on the representation of employees in management bodies as provided for in national laws, collective agreements or practice; and (i) where a CCP is part of a group, resolution authorities take account of the impact on other group entities, in particular where such group comprises other FMIs, and on the group as a whole. 2. Resolution authorities may take a resolution action which deviates from the principles set out in points (d) or (e) of paragraph 1 of this Article where it is justified in the public interest to achieve the resolution objectives and is proportionate to the risk addressed. However, where that deviation results in a shareholder, a clearing member or any other creditor incurring greater losses than it would have incurred in the circumstances referred to in Article 60, the entitlement to payment of the difference under Article 62 shall apply. 3. The board and senior management of a CCP under resolution shall provide the resolution authority with all necessary assistance for the achievement of the resolution objectives. CHAPTER II Valuation Article 24 Objectives of valuation 1. Resolution authorities shall ensure that any resolution action is taken on the basis of a valuation ensuring a fair, prudent and realistic assessment of the assets, liabilities, rights and obligations of the CCP. 2. Before the resolution authority places a CCP under resolution, it shall ensure that a first valuation is carried out to determine whether the conditions for resolution under Article 22(1) are met. 3. After the resolution authority has decided to place a CCP under resolution, it shall ensure that a second valuation is carried out to: (a) inform the decision on the appropriate resolution action to be taken; (b) ensure that any losses on the assets and rights of the CCP are fully recognised at the moment the resolution tools are applied; (c) inform the decision on the extent of the cancellation or dilution of instruments of ownership and the decision on the value and number of instruments of ownership issued or transferred as a result of the exercise of resolution powers; (d) inform the decision on the extent of the write-down or conversion of any unsecured liabilities, including debt instruments; (e) where the loss and position allocation tools are applied, inform the decision on the extent of losses to be applied against affected creditors’ claims, outstanding obligations or positions in relation to the CCP and on the extent and necessity of a resolution cash call; (f) where the bridge CCP tool is applied, inform the decision on the assets, liabilities, rights and obligations or instruments of ownership that may be transferred to the bridge CCP and the decision on the value of any consideration that may be paid to the CCP under resolution or, where relevant, to the holders of the instruments of ownership; (g) where the sale of business tool is applied, inform the decision on the assets, liabilities, rights and obligations or instruments of ownership that may be transferred to the third party purchaser and to inform the resolution authority’s understanding of what constitutes commercial terms for the purposes of Article 40. For the purposes of point (d), the valuation shall take into account any losses that would be absorbed by the enforcement of any outstanding obligations of the clearing members or other third parties owed to the CCP and the level of conversion to be applied to debt instruments. 4. The valuations referred to in paragraphs 2 and 3 of this Article may be subject to an appeal in accordance with Article 74 only together with the decision to apply a resolution tool or to exercise a resolution power. Article 25 Requirements for valuation 1. The resolution authority shall ensure that the valuations referred to in Article 24 are carried out: (a) by a person independent from any public authority and from the CCP; or (b) by the resolution authority, where those valuations cannot be carried out by a person as referred to in point (a). 2. The valuations referred to in Article 24 shall be considered definitive where they are carried out by the person referred to in point (a) of paragraph 1 of this Article and all the requirements laid down in this Article are fulfilled. 3. Without prejudice to the Union State aid framework, where applicable, a definitive valuation shall be based on prudent assumptions and shall not assume any potential provision of extraordinary public financial support, any central bank emergency liquidity assistance or any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms to the CCP from the point in time at which resolution action is taken. The valuation shall also take account of the potential recovery of any reasonable expenses incurred by the CCP under resolution in accordance with Article 27(10). 4. A definitive valuation shall be supplemented by the following information held by the CCP: (a) an updated balance sheet and a report on the financial position of the CCP, including the remaining available pre-funded resources and outstanding financial commitments; (b) the records of cleared contracts referred to in Article 29 of Regulation (EU) No 648/2012; and (c) any information on the market and accounting values of its assets, liabilities and positions, including relevant claims and outstanding obligations owed or due to the CCP. 5. A definitive valuation shall indicate the subdivision of the creditors in classes in accordance with their priority levels under the applicable insolvency law. It shall also include an estimate of the treatment that each class of shareholders and creditors would have been expected to receive in application of the principle specified in point (e) of Article 23(1). The estimate referred to in the first subparagraph shall not prejudice the valuation referred to in Article 61. 6. ESMA, taking into account the regulatory technical standards developed in accordance with Article 36(14) and (15) of Directive 2014/59/EU and adopted pursuant to Article 36(16) thereof, shall develop draft regulatory technical standards to specify: (a) the circumstances in which a person is deemed to be independent from both the resolution authority and from the CCP for the purposes of paragraph 1 of this Article; (b) the methodology for assessing the value of the assets and liabilities of the CCP; and (c) the separation of the valuations under Articles 24 and 61 of this Regulation. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 26 Provisional valuation 1. The valuations referred to in Article 24 that do not meet the requirements laid down in Article 25(2) shall be considered to be provisional valuations. Provisional valuations shall include a buffer for additional losses and an appropriate justification for that buffer. 2. Where resolution authorities take resolution action on the basis of a provisional valuation, they shall ensure that a definitive valuation is carried out as soon as practicable. The resolution authority shall ensure that the definitive valuation referred to in the first subparagraph: (a) allows for full recognition of any losses of the CCP in its books; (b) informs a decision to write back creditors’ claims or to increase the value of the consideration paid, in accordance with paragraph 3. 3. Where the definitive valuation’s estimate of the net asset value of the CCP is higher than the provisional valuation’s estimate of the net asset value of the CCP, the resolution authority may: (a) increase the value of the claims of affected creditors which have been written down or restructured; (b) require a bridge CCP to make a further payment of consideration in respect of the assets, liabilities, rights and obligations to the CCP under resolution or, as the case may be, in respect of the instruments of ownership to the owners of those instruments. 4. ESMA, taking into account the regulatory technical standards developed in accordance with Article 36(15) of Directive 2014/59/EU and adopted pursuant to Article 36(16) thereof, shall develop draft regulatory technical standards to specify, for the purposes of paragraph 1 of this Article, the methodology for calculating the buffer for additional losses to be included in provisional valuations. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. CHAPTER III Resolution tools Section 1 General principles Article 27 General provisions on resolution tools 1. Resolution authorities shall take resolution actions referred to in Article 21 by applying any of the following resolution tools individually or in any combination: (a) the position and loss allocation tools; (b) the write-down and conversion tool; (c) the sale of business tool; (d) the bridge CCP tool. 2. In the event of a systemic crisis, a Member State may as a last resort provide extraordinary public financial support by applying government stabilisation tools in accordance with Articles 45, 46 and 47 on the condition of prior and final approval under the Union State aid framework and where credible arrangements for the timely and comprehensive recovery of the funds in accordance with paragraph 10 of this Article are provided for. 3. Prior to the application of the tools referred to in paragraph 1, the resolution authority shall enforce: (a) any existing and outstanding rights of the CCP, including any contractual obligations by clearing members to meet recovery cash calls, to provide additional resources to the CCP, or to take on positions of defaulting clearing members, whether through an auction or other agreed means in the CCP’s operating rules; (b) any existing and outstanding contractual obligation committing parties other than clearing members to any forms of financial support. The resolution authority may partially enforce the contractual obligations referred to in points (a) and (b) where it is not possible to enforce those contractual obligations in full within a reasonable timeframe. 4. By way of derogation from paragraph 3, the resolution authority may refrain from enforcing the relevant existing and outstanding obligations either partially or in full to avoid significant adverse effects on the financial system or widespread contagion, or where the application of the tools referred to in paragraph 1 is more appropriate in order to achieve the resolution objectives in a timely manner. 5. In the event that the resolution authority refrains partially or fully from enforcing existing and outstanding obligations as set out in the second subparagraph of paragraph 3 or in paragraph 4 of this Article, the resolution authority may enforce the remaining obligations within 18 months after the CCP is considered to be failing or likely to fail in accordance with Article 22, provided that the reasons for refraining from enforcing those obligations no longer exist. The resolution authority shall notify the clearing member and other party three to six months before enforcing the remaining obligation. The proceeds from the enforced remaining obligations shall be used to recover the use of public funds. The resolution authority shall, after consultation with the competent authorities and resolution authorities of the affected clearing members and any other parties committed by existing and outstanding obligations, determine whether the reasons for refraining from enforcing the existing and outstanding obligations have ceased to exist and whether to enforce remaining obligations. Where the resolution authority deviates from the views expressed by the authorities consulted, it shall provide duly justified reasons, in writing, for doing so. The requirement to meet the remaining obligations in the circumstances referred to in this paragraph shall be included in the CCP’s rules and other contractual arrangements. 6. The resolution authority may require the CCP to compensate non-defaulting clearing members for their losses stemming from the application of loss allocation tools, where those losses are in excess of the losses that the non-defaulting clearing member would have borne under their obligations under the CCP’s operating rules, provided that the non-defaulting clearing member would have been entitled to the payment of the difference referred to in Article 62. The compensation referred to in the first subparagraph may take the form of instruments of ownership, debt instruments or instruments recognising a claim on the CCP’s future profits. The amount of instruments issued to each affected non-defaulting clearing member shall be proportionate to the excess loss referred to in the first subparagraph. It shall take account of any outstanding contractual obligations of the clearing members toward the CCP and be deducted from any entitlement to the payment of the difference referred to in Article 62. The amount of instruments shall be based on the valuation conducted in accordance with Article 24(3). 7. Where one of the government stabilisation tools is applied, the resolution authority shall exercise the power to write down and convert any instruments of ownership and debt instruments or other unsecured liabilities before or together with the application of the government stabilisation tool. Where the application of a resolution tool other than the write-down and conversion tool results in financial losses being borne by clearing members, the resolution authority shall exercise the power to write down and convert any instruments of ownership and debt instruments or other unsecured liabilities immediately before or together with the application of the resolution tool, unless applying a different sequence would minimise deviations from the ‘no creditor worse off’ principle set out in Article 60 and better achieve the resolution objectives. 8. Where only the resolution tools referred to in points (c) and (d) of paragraph 1 of this Article are applied, and only part of the assets, rights, obligations or liabilities of the CCP under resolution are transferred in accordance with Articles 40 and 42, the residual part of that CCP shall be wound up in accordance with normal insolvency proceedings. 9. National insolvency law rules relating to the voidability or unenforceability of legal acts detrimental to creditors shall not apply to transfers of assets, rights, obligations or liabilities from a CCP in relation to which resolution tools or government financial stabilisation tools are applied. 10. Member States shall recover over an appropriate period any public funds used as government financial stabilisation tools as referred to in Section 7 of this Chapter and resolution authorities shall recover any reasonable expenses incurred by them in connection with the application of the resolution tools or powers. Such recovery shall, inter alia, come from: (a) the CCP under resolution, as a preferred creditor, including any of its claims against defaulting clearing members; (b) any consideration paid by the purchaser to the CCP, as a preferred creditor prior to the application of Article 40(4), where the sale of business tool has been applied; (c) any proceeds generated as a result of the termination of the bridge CCP, as a preferred creditor prior to the application of Article 42(5); (d) any proceeds generated by the application of the public equity support tool referred to in Article 46 and the temporary public ownership tool referred to in Article 47, including the proceeds generated from their sale. 11. When applying the resolution tools, resolution authorities shall ensure, on the basis of a valuation that complies with Article 25, the restoration of a matched book, the full allocation of losses, the replenishment of the pre-funded resources of the CCP or the bridge CCP, and the recapitalisation of the CCP or the bridge CCP. Resolution authorities shall ensure the replenishment of the pre-funded resources and the recapitalisation of the CCP or the bridge CCP as referred to in the first subparagraph, to an extent sufficient to restore the ability of the CCP or the bridge CCP to comply with the conditions for authorisation and to continue to carry out the critical functions of the CCP or the bridge CCP, taking into account the operating rules of the CCP or the bridge CCP. Notwithstanding the application of other resolution tools, resolution authorities may apply the tools referred to in Articles 30 and 31 to recapitalise the CCP. Section 2 Position allocation and loss allocation tools Article 28 Objective and scope of the position and loss allocation tools 1. Resolution authorities shall apply the position allocation tool in accordance with Article 29 and the loss allocation tools in accordance with Articles 30 and 31. 2. Resolution authorities shall apply the tools referred to in paragraph 1 in respect of contracts relating to clearing services and the collateral related to those services posted to the CCP. 3. Resolution authorities shall apply the position allocation tool referred to in Article 29 in order to rematch the book of the CCP or bridge CCP where relevant. Resolution authorities shall apply the loss allocation tools referred to in Articles 30 and 31 for any of the following purposes: (a) to cover the losses of the CCP assessed in accordance with Article 25; (b) to restore the ability of the CCP to meet payment obligations as they fall due; (c) to achieve the outcome referred to in points (a) and (b) in relation to a bridge CCP; (d) to support the transfer of the CCP’s business by way of the sale of business tool to a solvent third party. The loss allocation tool referred to in Article 30 may be applied by the resolution authorities in relation to losses arising from a default event and in relation to losses arising from a non-default event. If the loss allocation tool referred to in Article 30 is applied in relation to losses arising from a non-default event, it shall only be applied up to a cumulative amount equivalent to the non-defaulting clearing members’ contribution to the CCP’s default funds and distributed among clearing members proportionally to their contributions to the default funds. 4. Resolution authorities shall not apply the loss allocation tools referred to in Articles 30 and 31 of this Regulation with regard to the entities referred to in Articles 1(4) and 1(5) of Regulation (EU) No 648/2012. Article 29 Termination of contracts – partial or full 1. The resolution authority may terminate some or all of the following contracts of the CCP under resolution: (a) the contracts with the clearing member in default; (b) the contracts of the affected clearing service or asset class; (c) the other contracts of the CCP under resolution. The resolution authority shall terminate the contracts referred to in point (a) of the first subparagraph of this paragraph only where the transfer of the assets and positions resulting from those contracts has not taken place within the meaning of Article 48(5) and (6) of Regulation (EU) No 648/2012. When using the power under the first subparagraph, the resolution authority shall terminate contracts referred to under each of points (a), (b) and (c) of the first subparagraph in a similar way, without discriminating between counterparties to those contracts, with the exception of those contractual obligations that cannot be enforced in a reasonable timeframe. 2. The resolution authority shall give notice to all relevant clearing members of the date on which any contract referred to in paragraph 1 is terminated. 3. Prior to the termination of any of the contracts referred to in paragraph 1, the resolution authority shall take the following steps: (a) require the CCP under resolution to value each contract, and update the account balances of each clearing member; (b) determine the net amount payable by or to each clearing member, taking account of any due but unpaid variation margin, including variation margin due as a result of the contract valuations referred to in point (a); and (c) notify each clearing member of the determined net amounts and require the CCP to pay or collect them accordingly. The clearing members shall, without undue delay, communicate the application of such tool to their clients and the way in which such application affects them. 4. The valuation referred in point (a) of paragraph 3 shall be based, as far as possible, on a fair market price determined on the basis of the CCP’s own rules and arrangements, unless the resolution authority deems necessary the use of another appropriate price discovery method. 5. Where a non-defaulting clearing member is unable to pay the net amount determined in accordance with paragraph 3 of this Article, the resolution authority may, having regard to Article 21 of this Regulation, require the CCP to place the non-defaulting clearing member in default and use its initial margin and default fund contribution in accordance with Article 45 of Regulation (EU) No 648/2012. 6. Where the resolution authority has terminated one or more contracts of the types referred to in paragraph 1, it may temporarily prevent the CCP from clearing any new contract of the same type as the one terminated. The resolution authority may allow the CCP to resume the clearing of those types of contracts only where the following conditions are met: (a) the CCP complies with the requirements of Regulation (EU) No 648/2012; and (b) the resolution authority issues and publishes a notice to that effect using the means referred to in Article 72(3). 7. ESMA shall by 12 February 2022 issue guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010 further specifying the methodology to be used by the resolution authority for determining the valuation referred in point (a) of paragraph 3 of this Article. Article 30 Reduction of the value of any gains payable by the CCP to non-defaulting clearing members 1. The resolution authority may reduce the amount of the CCP’s payment obligations to non-defaulting clearing members where those obligations arise from gains due in accordance with the CCP’s processes for paying variation margin or a payment that has the same economic effect. 2. The resolution authority shall calculate any reduction in payment obligations referred to in paragraph 1 of this Article using an equitable allocation mechanism determined in the valuation conducted in accordance with Article 24(3) and communicated to the clearing members as soon as the resolution tool is applied. The clearing members shall, without undue delay, communicate the application of such tool to their clients and the way in which such application affects them. The total net gains to be reduced for each clearing member shall be proportional to the amounts due from the CCP. 3. The reduction in the value of gains payable shall take effect and shall be immediately binding on the CCP and affected clearing members from the moment at which the resolution authority takes the resolution action. 4. A non-defaulting clearing member shall not have any claim in any subsequent proceedings against the CCP, or its successor entity, arising from the reduction in payment obligations referred to in paragraph 1. The first subparagraph of this paragraph shall not prevent resolution authorities from requiring the CCP to reimburse clearing members, where the level of reduction based on the provisional valuation referred to in Article 26(1) is found to exceed the level of reduction required based on the definitive valuation referred to in Article 26(2). 5. Where a resolution authority reduces only in part the value of gains payable, the residual outstanding payable amount shall still be owed to the non-defaulting clearing member. 6. The CCP shall include in its operating rules reference to the power to reduce payment obligations referred to in paragraph 1 in addition to any similar arrangements provided for in those operating rules at the recovery stage and shall ensure that contractual arrangements are concluded to allow the resolution authority to exercise its powers under this Article. Article 31 Resolution cash call 1. The resolution authority may require non-defaulting clearing members to make a contribution in cash to the CCP up to twice the amount equivalent to their contribution to the CCP’s default fund. This obligation to make a contribution in cash shall also be included in the CCP’s rules and other contractual arrangements as a resolution cash call reserved to the resolution authority taking resolution action. Where the resolution authority calls for an amount in excess of the contribution to the default fund, it shall do so after assessing the impact of this tool on non-defaulting clearing members and the financial stability of Member States, in cooperation with the resolution authorities of non-defaulting clearing members. Where the CCP operates multiple default funds and the tool is applied to address a default event, the amount of the contribution in cash referred to in the first subparagraph shall refer to the contribution of the clearing member to the default fund of the affected clearing service or asset class. Where the CCP operates multiple default funds and the tool is applied to address a non-default event, the amount of the contribution in cash referred to in the first subparagraph shall refer to the sum of the contributions of the clearing member to all default funds of the CCP. The resolution authority may exercise the resolution cash call regardless of whether all contractual obligations requiring cash contributions from non-defaulting clearing members have been exhausted. The resolution authority shall determine the amount of the cash contribution of each non-defaulting clearing member in proportion to its contribution to the default fund up to the limit referred in the first subparagraph. The resolution authority may require the CCP to reimburse clearing members the possible excess amount of a resolution cash call where the level of the resolution cash call applied based on a provisional valuation according to Article 26(1) is found to exceed the required level based on the definitive valuation referred to in Article 26(2). 2. If a non-defaulting clearing member does not pay the required amount, the resolution authority may require the CCP to place that clearing member in default and use its initial margin and default fund contribution in accordance with Article 45 of Regulation (EU) No 648/2012 up to the required amount. Section 3 Write-down and conversion of instruments of ownership and debt instruments or other unsecured liabilities Article 32 Requirement to write down and convert instruments of ownership and debt instruments or other unsecured liabilities 1. The resolution authority shall apply the write-down and conversion tool in accordance with Article 33 in respect of instruments of ownership and debt instruments issued by the CCP under resolution or other unsecured liabilities in order to absorb losses, recapitalise that CCP or a bridge CCP, or to support the application of the sale of business tool. 2. Based on the valuation carried out in accordance with Article 24(3), the resolution authority shall determine the following: (a) the amount by which the instruments of ownership and debt instruments or other unsecured liabilities must be written down taking into account any losses that are to be absorbed by the enforcement of any outstanding obligations of the clearing members or other third parties owed to the CCP; and (b) the amount by which debt instruments or other unsecured liabilities must be converted into instruments of ownership in order to restore the capital requirements of the CCP or the bridge CCP. Article 33 Provisions governing the write-down or conversion of instruments of ownership and debt instruments or other unsecured liabilities 1. The resolution authority shall apply the write-down and conversion tool in accordance with the priority of claims applicable under normal insolvency proceedings. 2. Prior to reducing or converting the principal amount of debt instruments or other unsecured liabilities, the resolution authority shall reduce the nominal amount of instruments of ownership in proportion to the losses and up to their full value, where necessary. Where, in accordance with the valuation carried out pursuant to Article 24(3), the CCP maintains a positive net value after the reduction of the nominal amount of instruments of ownership, the resolution authority shall cancel or dilute, as the case may be, those instruments of ownership. 3. The resolution authority shall reduce, convert, or both, the principal amount of debt instruments or other unsecured liabilities to the extent required to achieve the resolution objectives, and up to the full value of those instruments or liabilities, where necessary. 4. The resolution authority shall not apply the write-down and conversion tool in respect of the following liabilities: (a) liabilities to employees, in relation to accrued salary, pension benefits or other fixed remuneration, except for any variable component of remuneration that is not regulated by a collective bargaining agreement; (b) liabilities to commercial or trade creditors arising from the provision to the CCP of goods or services that are critical to the daily functioning of its operations, including IT services, utilities and the rental, servicing and upkeep of premises; (c) liabilities to tax and social security authorities, provided that those liabilities are preferred liabilities under the applicable insolvency law; (d) liabilities owed to systems or operators of systems designated according to Directive 98/26/EC, to participants to the extent that the liabilities result from their participation in such systems, to other CCPs, and to central banks; (e) initial margins. 5. Where the nominal amount of an instrument of ownership or the principal amount of a debt instrument or other unsecured liabilities is reduced, the following conditions shall apply: (a) that reduction shall be permanent; (b) the holder of the instrument shall have no claim in connection with that reduction, except for any liability already accrued, any liability for damages that may arise as a result of an appeal challenging the legality of that reduction, any claim based on instruments of ownership issued or transferred pursuant to paragraph 6 of this Article, or any claim for payment in accordance with Article 62; and (c) where that reduction is only partial, the agreement that created the original liability shall continue to apply in respect of the residual amount subject to any necessary amendments of the terms of that agreement due to the reduction. Point (a) of the first subparagraph shall not prevent resolution authorities from applying a write-up mechanism to reimburse holders of debt instruments or other unsecured liabilities and then holders of instruments of ownership, where the level of write-down applied based on the provisional valuation referred to in Article 26(1) is found to exceed the amounts required based on the definitive valuation referred to in Article 26(2). 6. Where converting debt instruments or other unsecured liabilities pursuant to paragraph 3, the resolution authority may require the CCP to issue or to transfer instruments of ownership to the holders of the debt instruments or other unsecured liabilities. 7. The resolution authority shall only convert debt instruments or other unsecured liabilities pursuant to paragraph 3 where the following conditions are met: (a) the instruments of ownership are issued prior to any issuance of instruments of ownership by the CCP for the purposes of provision of own funds by the State or a government entity; and (b) the conversion rate represents appropriate compensation to the affected debt holders for any loss incurred as a result of the exercise of the write-down and conversion powers, in line with their treatment under normal insolvency proceedings. Following any conversion of debt instruments or other unsecured liabilities to instruments of ownership, the latter shall be subscribed or transferred without delay after the conversion. 8. For the purposes of paragraph 7, the resolution authority shall ensure, in the context of drawing up and maintaining the CCP’s resolution plan and as part of the powers to remove impediments to the resolvability of the CCP, that the CCP is at all times able to issue the necessary number of instruments of ownership. Article 34 Effect of write-down and conversion The resolution authority shall complete or require the completion of all the administrative and procedural tasks necessary to give effect to the application of the write-down and conversion tool, including: (a) the amendment of all relevant registers; (b) the delisting or removal from trading of instruments of ownership or debt instruments; (c) the listing or admission to trading of new instruments of ownership; and (d) the relisting or readmission of any debt instruments which have been written down, without the requirement for the issuing of a prospectus in accordance with Regulation (EU) 2017/1129 of the European Parliament and of the Council (24). Article 35 Removal of procedural obstacles for write-down and conversion 1. Where Article 32(1) is applied, the competent authority shall require the CCP to maintain at all times a sufficient amount of instruments of ownership to ensure that the CCP may issue sufficient new instruments of ownership and that the issuance of or conversion into instruments of ownership could be carried out effectively. 2. The resolution authority shall apply the write-down and conversion tool regardless of any provisions in the CCP’s instruments of incorporation or statutes, including with respect to pre-emption rights for shareholders or requirements for the consent of shareholders to an increase of capital. Article 36 Submission of a business reorganisation plan 1. CCPs shall, within one month after the application of the tools referred to in Article 32, conduct a review of the causes of its failure and submit it to the resolution authority alongside a business reorganisation plan in accordance with Article 37. Where the Union State aid framework is applicable, that plan, including following any amendments in accordance with Article 38 and as implemented in accordance with Article 39, shall be compatible with the restructuring plan that the CCP is required to submit to the Commission in accordance with that framework. Where necessary for achieving the resolution objectives, the resolution authority may extend the period referred to in the first subparagraph up to a maximum of two months. 2. Where a restructuring plan is required to be notified under the Union State aid framework, the submission of the business reorganisation plan shall be without prejudice to the deadline laid down by that framework for the submission of that restructuring plan. 3. The resolution authority shall submit the review and the business reorganisation plan, and any revised plan in accordance with Article 38, to the competent authority and to the resolution college. Article 37 Content of the business reorganisation plan 1. The business reorganisation plan referred to in Article 36 shall set out measures aiming to restore the long-term viability of the CCP or parts of its business within a reasonable timeframe. Those measures shall be based on realistic assumptions as to the economic and financial market conditions under which the CCP will operate. The business reorganisation plan shall take account of the current and potential states of the financial markets and reflect best-case and worst-case assumptions, including a combination of events to identify the CCP’s main vulnerabilities. Assumptions shall be compared with appropriate sector-wide benchmarks. 2. The business reorganisation plan shall include at least the following elements: (a) a detailed analysis of the factors and circumstances that caused the CCP to fail or to be likely to fail; (b) a description of the measures to be adopted to restore the CCP’s long-term viability; and (c) a timetable for the implementation of those measures. 3. Measures aiming to restore the long-term viability of a CCP may include: (a) the reorganisation and restructuring of the activities of the CCP; (b) changes to the CCP’s operational systems and infrastructure; (c) the sale of assets or of business lines; (d) changes to the CCP’s risk management. 4. ESMA shall by 12 February 2023 develop draft regulatory technical standards to specify further the minimum elements that should be included in a business reorganisation plan pursuant to paragraph 2. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 38 Assessment and adoption of the business reorganisation plan 1. Within one month of the submission of the business reorganisation plan by the CCP pursuant to Article 36(1), the resolution authority and the competent authority shall assess whether the measures provided for in that plan would reliably restore the long-term viability of the CCP. Where the resolution authority and the competent authority are satisfied that the plan would restore the CCP’s long-term viability, the resolution authority shall approve the plan. 2. Where the resolution authority or the competent authority are not satisfied that the measures provided for in the plan would restore the CCP’s long-term viability, the resolution authority shall notify the CCP of their concerns and require it to resubmit an amended plan addressing those concerns within two weeks of the notification. 3. The resolution authority and the competent authority shall assess the resubmitted plan and the resolution authority shall notify the CCP within one week of the reception of that plan whether the concerns are appropriately addressed or whether further amendments are required. 4. ESMA shall by 12 February 2023 develop draft regulatory technical standards to specify the criteria that a business reorganisation plan is to fulfil for approval by the resolution authority pursuant to paragraph 1. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 39 Implementation and monitoring of the business reorganisation plan 1. The CCP shall implement the business reorganisation plan and shall submit a report to the resolution authority and the competent authority as requested and, at least, every six months on its progress in implementing that plan. 2. The resolution authority, in agreement with the competent authority, may require the CCP to revise the plan where necessary to achieve the aim referred to in Article 37(1). Section 4 Sale of business tool Article 40 Sale of business tool 1. The resolution authority may transfer the following to a purchaser that is not a bridge CCP: (a) instruments of ownership issued by a CCP under resolution; (b) any assets, rights, obligations or liabilities of a CCP under resolution. The transfer referred to in the first subparagraph shall take place without obtaining the consent of the shareholders of the CCP, or any third party other than the purchaser and without complying with any procedural requirements under company or securities law other than those provided for in Article 41. 2. A transfer made pursuant to paragraph 1 shall be made on commercial terms, having regard to the circumstances, and in accordance with the Union State aid framework. For the purposes of the first subparagraph of this paragraph, the resolution authority shall take all reasonable steps to obtain commercial terms that conform to the valuation conducted under Article 24(3). 3. Subject to Article 27(10), any consideration paid by the purchaser shall benefit: (a) the owners of the instruments of ownership where the sale of business has been effected by transferring instruments of ownership issued by the CCP under resolution from the holders of those instruments to the purchaser; (b) the CCP under resolution, where the sale of business has been effected by transferring some or all of the assets or liabilities of the CCP to the purchaser; (c) any non-defaulting clearing members that have suffered losses resulting from the application of the resolution tools in resolution, proportionate to their losses in resolution. 4. The allocation of any consideration paid by the purchaser in accordance with paragraph 3 of this Article shall be carried out as follows: (a) upon the occurrence of an event covered by the CCP’s default waterfall as set out in Articles 43 and 45 of Regulation (EU) No 648/2012, in a reversal of the order in which the losses have been imposed by the CCP’s default waterfall; or (b) upon the occurrence of an event not covered by the CCP’s default waterfall as set out in Articles 43 and 45 of Regulation (EU) No 648/2012, in a reversal of the order in which the losses were allocated in accordance with any applicable rules of the CCP. The allocation of any remaining consideration shall then be carried out in accordance with the priority of claims under normal insolvency proceedings. 5. The resolution authority may exercise the transfer power referred to in paragraph 1 more than once in order to make supplemental transfers of instruments of ownership issued by the CCP or, as the case may be, the CCP’s assets, rights, obligations, or liabilities. 6. The resolution authority may, with the consent of the purchaser, transfer the assets, rights, obligations or liabilities that had been transferred to the purchaser back to the CCP under resolution, or the instruments of ownership back to their original owners. Where the resolution authority uses the transfer power referred to in the first subparagraph, the CCP under resolution or original owners shall be obliged to take back any such assets, rights, obligations or liabilities, or instruments of ownership. 7. Any transfer made pursuant to paragraph 1 shall take place irrespective of whether the purchaser is authorised to provide the services and carry out the activities resulting from the acquisition. Where the purchaser is not authorised to provide the services and carry out the activities resulting from the acquisition, the resolution authority, in consultation with the competent authority, shall conduct an appropriate due diligence assessment of the purchaser and ensure that the purchaser has the professional and technical capacity to perform the functions of the purchased CCP and that it applies for authorisation as soon as practicable and, at the latest, within one month of the application of the sale of business tool. The competent authority shall ensure that any such application for authorisation is considered in an expedited manner. 8. Where the transfer of instruments of ownership referred to in paragraph 1 of this Article results in the acquisition of or increase in a qualifying holding referred to in Article 31(2) of Regulation (EU) No 648/2012, the competent authority shall carry out the assessment referred to in that Article within a period that neither delays the application of the sale of business tool nor prevents the resolution action from achieving the relevant resolution objectives. 9. Where the competent authority has not completed the assessment referred to in paragraph 8 by the date on which the transfer of instruments of ownership takes effect, the following shall apply: (a) the transfer of instruments of ownership shall have immediate legal effect from the date on which they are transferred; (b) during the assessment period and during any divestment period provided for in point (f) of this paragraph, the purchaser’s voting rights attached to those instruments of ownership shall be suspended and vested solely in the resolution authority, which shall have no obligation to exercise them and, unless the act or omission implies gross negligence or serious misconduct, shall not be liable for exercising or refraining from exercising them; (c) during the assessment period and during any divestment period provided for in point (f) of this paragraph, any penalties provided for in Article 22(3) of Regulation (EU) No 648/2012 or measures for infringing the requirements for acquisitions or disposals of qualifying holdings provided for in Article 30 of Regulation (EU) No 648/2012 shall not apply to that transfer; (d) the competent authority shall notify the resolution authority and the purchaser in writing of the result of its assessment in accordance with Article 32 of Regulation (EU) No 648/2012 promptly after completing its assessment; (e) where the competent authority does not oppose the transfer, the voting rights attached to those instruments of ownership shall be deemed to be fully vested in the purchaser as from the notification referred to in point (d) of this paragraph; (f) where the competent authority opposes the transfer of instruments of ownership, point (b) shall continue to apply and the resolution authority may, having taken into account market conditions, establish a divestment period within which the purchaser shall divest such instruments of ownership. 10. For the purposes of exercising its right to provide services in accordance with Regulation (EU) No 648/2012, the purchaser shall be considered to be a continuation of the CCP under resolution, and may continue to exercise any such right that was exercised by the CCP under resolution in respect of the assets, rights, obligations or liabilities transferred. 11. The purchaser referred to in paragraph 1 shall not be prevented from exercising the CCP’s rights of membership and accessing the payment and settlement systems and other linked FMIs and trading venues provided that the purchaser meets the criteria for membership or participation in those systems or infrastructures or trading venues. Notwithstanding the first subparagraph, the purchaser shall not be denied access to payment and settlement systems, and other linked FMIs and trading venues, on the ground that the purchaser does not possess a rating from a credit rating agency, or that that rating is below the rating levels required to be granted access to those systems or infrastructures or trading venues. Where the purchaser does not meet the criteria referred to in the first subparagraph, the purchaser may continue to exercise the CCP’s rights of membership and accessing those systems and other infrastructures and trading venues for the period specified by the resolution authority. That period shall not exceed 12 months. 12. Unless otherwise provided for in this Regulation, shareholders, creditors, clearing members and clients of the CCP under resolution and other third parties whose assets, rights, obligations or liabilities are not transferred shall have no rights over, or in relation to, the assets, rights, obligations or liabilities transferred. Article 41 Sale of business tool: procedural requirements 1. Where applying the sale of business tool in relation to a CCP, the resolution authority shall advertise the availability, or make arrangements for the marketing, of the assets, rights, obligations, liabilities, or the instruments of ownership intended to be transferred. Pools of rights, assets, obligations and liabilities may be marketed separately. 2. Without prejudice to the Union State aid framework, where applicable, the marketing referred to in paragraph 1 shall be carried out in accordance with the following criteria: (a) it shall be as transparent as possible and not materially misrepresent the assets, rights, obligations, liabilities, or instruments of ownership of the CCP, having regard to the circumstances and in particular the need to maintain financial stability; (b) it shall not unduly favour or discriminate between potential purchasers; (c) it shall be free from any conflict of interest; (d) it shall take account of the need to effect a rapid resolution action; and (e) it shall aim to maximise, as far as possible, the sale price for the instruments of ownership, assets, rights, obligations or liabilities involved. The criteria referred to in the first subparagraph shall not prevent the resolution authority from soliciting particular potential purchasers. 3. By way of derogation from paragraphs 1 and 2, the resolution authority may apply the sale of business tool without complying with the requirement to market, or may market the assets, rights, obligations, liabilities or the instruments of ownership where it determines that compliance with that requirement or with those criteria would be likely to undermine one or more of the resolution objectives, including by creating a material threat to financial stability. Section 5 Bridge CCP tool Article 42 Bridge CCP tool 1. The resolution authority may transfer to a bridge CCP the following: (a) instruments of ownership issued by a CCP under resolution; (b) any assets, rights, obligations or liabilities of the CCP under resolution. The transfer referred to in the first subparagraph may take place without obtaining the consent of the shareholders of the CCP under resolution or any third party other than the bridge CCP and without complying with any procedural requirements under company or securities law other than those provided for in Article 43. 2. The bridge CCP shall be a legal person that: (a) is controlled by the resolution authority and is wholly or partially owned by one or more public authorities which may include the resolution authority; and (b) is established or used for the purpose of receiving and holding some or all of the instruments of ownership issued by a CCP under resolution or some or all of the assets, rights, obligations and liabilities of the CCP with a view to maintaining the critical functions of the CCP and subsequently selling the CCP. 3. When applying the bridge CCP tool, the resolution authority shall ensure that the total value of liabilities and obligations transferred to the bridge CCP does not exceed the total value of the rights and assets transferred from the CCP under resolution. 4. Subject to Article 27(10), any consideration paid by the bridge CCP shall benefit: (a) the owners of the instruments of ownership, where the transfer to the bridge CCP has been effected by transferring instruments of ownership issued by the CCP under resolution from the holders of those instruments to the bridge CCP; (b) the CCP under resolution, where the transfer to the bridge CCP has been effected by transferring some or all of the assets or liabilities of that CCP to the bridge CCP; (c) any non-defaulting clearing members that have suffered losses following the application of the resolution tools in resolution, proportionate to their losses in resolution. 5. The allocation of any consideration paid by the bridge CCP in accordance with paragraph 4 of this Article shall be carried out as follows: (a) upon the occurrence of an event covered by the CCP’s default waterfall as set out in Articles 43 and 45 of Regulation (EU) No 648/2012, in a reversal of the order in which the losses have been imposed by the CCP’s default waterfall; or (b) upon the occurrence of an event not covered by the CCP’s default waterfall as set out in Articles 43 and 45 of Regulation (EU) No 648/2012, in a reversal of the order in which the losses were allocated in accordance with any applicable rules of the CCP. The allocation of any remaining consideration shall be carried out in accordance with the priority of claims under normal insolvency proceedings. 6. The resolution authority may exercise the transfer power referred to in paragraph 1 more than once in order to make supplemental transfers of instruments of ownership issued by a CCP or of its assets, rights, obligations or liabilities. 7. The resolution authority may transfer the rights, obligations, assets or liabilities that had been transferred to the bridge CCP back to the CCP under resolution, or the instruments of ownership back to their original owners where that transfer is expressly provided for in the instrument by which the transfer referred to in paragraph 1 is made. Where the resolution authority uses the transfer power referred to in the first subparagraph, the CCP under resolution or original owners shall be obliged to take back any such assets, rights, obligations or liabilities, or instruments of ownership, provided that the conditions in the first subparagraph of this paragraph or in paragraph 8 are met. 8. Where the specific instruments of ownership, assets, rights, obligations or liabilities do not fall within the classes of, or meet the conditions for transfer of, instruments of ownership, assets, rights, obligations or liabilities specified in the instrument by which the transfer was made, the resolution authority may transfer them from the bridge CCP back to the CCP under resolution or the original owners. 9. A transfer referred to in paragraphs 7 and 8 may be made at any time, and shall comply with any other conditions stated in the instrument by which the transfer was made for the relevant purpose. 10. The resolution authority may transfer instruments of ownership or assets, rights, obligations or liabilities from the bridge CCP to a third party. 11. For the purposes of exercising its right to provide services in accordance with Regulation (EU) No 648/2012, a bridge CCP shall be considered to be a continuation of the CCP under resolution and may continue to exercise any such right that was exercised by the CCP under resolution in respect of the assets, rights, obligations or liabilities transferred. For any other purposes, resolution authorities may require that a bridge CCP be considered to be a continuation of the CCP under resolution, and be able to continue to exercise any right that was exercised by the CCP under resolution in respect of the assets, rights, obligations or liabilities transferred. 12. The bridge CCP shall not be prevented from exercising the CCP’s rights of membership and accessing payment and settlement systems and other linked FMIs and trading venues, provided that it meets the criteria for membership and participation in those systems or FMIs or trading venues. Notwithstanding the first subparagraph, the bridge CCP shall not be denied access to payment and settlement systems and other FMIs and trading venues on the ground that the bridge CCP does not possess a rating from a credit rating agency, or that that rating is below the rating levels required to be granted access to those systems or infrastructures or trading venues. Where the bridge CCP does not meet the criteria referred to in the first subparagraph, the bridge CCP may continue to exercise the CCP’s rights of membership and accessing those systems and other infrastructures and trading venues for a period specified by the resolution authority. That period shall not exceed 12 months. 13. Shareholders, creditors, clearing members and clients of the CCP under resolution and other third parties whose assets, rights, obligations or liabilities are not transferred to the bridge CCP, shall have no rights over, or in relation to, the assets, rights, obligations or liabilities transferred to the bridge CCP, or against its board or senior management. 14. The bridge CCP shall have no duty or responsibility to shareholders or creditors of the CCP under resolution, and the board or senior management of the bridge CCP shall have no liability to those shareholders or creditors for acts and omissions in the discharge of their duties, unless the act or omission is due to gross negligence or serious misconduct in accordance with applicable national law. Article 43 Bridge CCP: procedural requirements 1. The bridge CCP shall comply with all of the following requirements: (a) the bridge CCP shall seek the approval of the resolution authority for all of the following: (i) the rules of incorporation of the bridge CCP; (ii) the members of the bridge CCP’s board, where those members are not directly appointed by the resolution authority; (iii) the responsibilities and remuneration of the members of the bridge CCP’s board, where the remuneration and the responsibilities are not determined by the resolution authority; and (iv) the strategy and risk profile of the bridge CCP; and (b) the bridge CCP shall take over the authorisations of the CCP under resolution to provide the services or carry out the activities resulting from the transfer referred to in Article 42(1) of this Regulation in accordance with Regulation (EU) No 648/2012. Notwithstanding point (b) of the first subparagraph and where necessary to meet the resolution objectives, the bridge CCP may be authorised without complying with Regulation (EU) No 648/2012 for a short period at the beginning of its operation. To that end, the resolution authority shall submit a request for such authorisation to the competent authority. If the competent authority decides to grant such authorisation, it shall indicate the period for which the bridge CCP’s obligation to comply with the requirements of Regulation (EU) No 648/2012 is waived. That period shall not exceed 12 months. During that period, the bridge CCP shall be considered as a qualifying CCP as defined in point (88) of Article 4(1) of Regulation (EU) No 575/2013 for the purposes of that Regulation. Notwithstanding the period referred to in the second subparagraph, in the case of prudential requirements under Chapter 3 of Title IV of Regulation (EU) No 648/2012, the waiver shall only be for a period of up to three months. It may be extended for one or two further periods of up to three months if necessary to achieve the resolution objectives. 2. Subject to any restrictions imposed in accordance with Union or national competition rules, the management of the bridge CCP shall operate the bridge CCP with the objective of maintaining continuity of the bridge CCP’s critical functions and selling the bridge CCP or any of its assets, rights, obligations and liabilities to one or more private sector purchasers. That sale shall take place when market conditions are appropriate, and within the period specified in paragraphs 5 and, where applicable, 6. 3. The resolution authority shall take a decision that the bridge CCP is no longer a bridge CCP within the meaning of Article 42(2) in any of the following cases: (a) the resolution objectives are fulfilled; (b) the bridge CCP merges with another entity; (c) the bridge CCP ceases to meet the requirements laid down in Article 42(2); (d) the bridge CCP or substantially all of its assets, rights, obligations or liabilities have been sold in accordance with paragraphs 2 and 4 of this Article; (e) the period specified in paragraph 5 of this Article or, where applicable, paragraph 6 of this Article expires; (f) the contracts cleared by the bridge CCP have been settled, have expired or have been closed out and the CCP’s rights and obligations relating to those contracts are thereby completely discharged. 4. Before selling the bridge CCP or its assets, rights, obligations or liabilities, the resolution authority shall advertise the availability of the elements intended to be sold, and shall ensure that they are marketed openly and transparently, and that they are not materially misrepresented. The resolution authority shall carry out the sale referred to in the first subparagraph on commercial terms and shall not unduly favour or discriminate between potential purchasers. 5. The resolution authority shall terminate the operation of a bridge CCP two years after the date on which the last transfer from the CCP under resolution is made. Where the resolution authority terminates the operation of a bridge CCP, it shall request the competent authority to withdraw the bridge CCP’s authorisation. 6. The resolution authority may extend the period referred to in paragraph 5 for one or more additional one-year periods where the extension is necessary to achieve the outcomes referred to in points (a) to (d) of paragraph 3. The decision to extend the period referred to in paragraph 5 shall be reasoned and shall contain a detailed assessment of the bridge CCP’s situation in relation to relevant market conditions and market outlook. 7. Where the operations of a bridge CCP are terminated in the circumstances referred to in point (d) or (e) of paragraph 3, the bridge CCP shall be wound up under normal insolvency proceedings. Unless otherwise provided for in this Regulation, any proceeds generated as a result of the termination of the bridge CCP shall benefit its shareholders. Where a bridge CCP is used for the purpose of transferring assets and liabilities of more than one CCP under resolution, the proceeds referred to in the second subparagraph shall be attributed by reference to the assets and liabilities transferred from each of the CCPs under resolution. Section 6 Additional financing arrangements Article 44 Alternative funding means The resolution authority may enter into contracts to borrow or obtain other forms of financial support, including from pre-funded resources available in any non-depleted default funds in the CCP under resolution, where necessary to meet temporary liquidity needs in order to ensure the effective application of the resolution tools. Section 7 Government stabilisation tools Article 45 Government financial stabilisation tools 1. In the very extraordinary situation of a systemic crisis, Member States may apply the government stabilisation tools in accordance with Articles 46 and 47 for the purpose of resolving a CCP only where the following conditions are met: (a) the financial support is necessary to meet the resolution objectives referred to in Article 21; (b) the financial support is used only as a last resort in accordance with paragraph 3 of this Article after having assessed and exploited all resolution tools to the maximum extent practicable whilst maintaining financial stability; (c) the financial support is limited in time; (d) the financial support complies with the Union State aid framework; and (e) the Member State has, in advance, defined comprehensive and credible arrangements, in a manner consistent with the Union state aid framework, for recovering, over a suitable period, and in accordance with Article 27(10) the public funds deployed, to the extent not retrieved in full through the sale to private purchasers in accordance with Article 46(3) or 47(2). The application of government stabilisation tools shall be carried out in accordance with national law either under the leadership of the competent ministry or government in close cooperation with the resolution authority or under the leadership of the resolution authority. 2. To give effect to the government financial stabilisation tools, competent ministries or governments shall have the relevant resolution powers specified in Articles 48 to 58, and shall ensure that Articles 52, 54 and 72 are complied with. 3. Government financial stabilisation tools shall be deemed to be applied as a last resort for the purposes of point (b) of paragraph 1 where at least one of the following conditions is met: (a) the competent ministry or government and the resolution authority, after consulting the central bank and the competent authority, determine that the application of remaining resolution tools would not suffice to avoid a significant adverse effect on the financial system; (b) the competent ministry or government and the resolution authority determine that the application of remaining resolution tools would not suffice to protect the public interest, where extraordinary liquidity assistance from the central bank has previously been given to the CCP; (c) in respect of the temporary public ownership tool, the competent ministry or government, after consulting the competent authority and the resolution authority, determines that the application of remaining resolution tools would not suffice to protect the public interest, where public equity support through the equity support tool has previously been given to the CCP. Article 46 Public equity support tool 1. Public financial support may be provided for the recapitalisation of a CCP in exchange for instruments of ownership. 2. CCPs subject to the public equity support tool shall be managed on a commercial and professional basis. 3. The instruments of ownership referred to in paragraph 1 shall be sold to a private purchaser as soon as commercial and financial circumstances allow. Article 47 Temporary public ownership tool 1. A CCP may be taken into temporary public ownership by means of one or more transfer orders of instruments of ownership executed by a Member State to a transferee which is either of the following: (a) a nominee of the Member State; or (b) a company wholly owned by the Member State. 2. CCPs subject to the temporary public ownership tool shall be managed on a commercial and professional basis and, having regard to the possibility of recovering the cost of resolution, shall be sold to a private purchaser as soon as commercial and financial circumstances allow. In determining the timing of the sale of the CCP, the financial situation and relevant market conditions shall be taken into account. CHAPTER IV Resolution powers Article 48 General powers 1. The resolution authority shall have all the powers necessary to apply the resolution tools effectively, including all the following powers: (a) to require any person to provide the resolution authority with any information it requires to decide upon and prepare a resolution action, including updates and additional information to that provided in the resolution plan or required through on-site inspections; (b) to take control of a CCP under resolution and exercise all the rights and powers conferred upon holders of instruments of ownership and the CCP’s board including the rights and powers under the operating rules of the CCP; (c) to transfer instruments of ownership issued by a CCP under resolution; (d) to transfer to another entity, with its consent, the CCP’s rights, assets, obligations or liabilities; (e) to reduce, including to reduce to zero, the principal amount of or outstanding amount due in respect of debt instruments or other unsecured liabilities of a CCP under resolution; (f) to convert debt instruments or other unsecured liabilities of a CCP under resolution into instruments of ownership of that CCP or of a bridge CCP to which assets, rights, obligations or liabilities of the CCP under resolution have been transferred; (g) to cancel debt instruments issued by a CCP under resolution; (h) to reduce, including to reduce to zero, the nominal amount of instruments of ownership of a CCP under resolution and to cancel such instruments of ownership; (i) to require a CCP under resolution to issue new instruments of ownership, including preference shares and contingent convertible instruments; (j) with regards to debt instruments and other liabilities of the CCP, to amend or alter their maturity, amend the amount of interest payable, or amend the date on which interest becomes payable, including by suspending payment for a temporary period; (k) to close out and terminate financial contracts; (l) to remove or replace the board and senior management of a CCP under resolution; (m) to require the competent authority to assess the buyer of a qualifying holding in a timely manner by way of derogation from the time-limits laid down in Article 31 of Regulation (EU) No 648/2012; (n) to reduce, including to reduce to zero, the amount of variation margin due to a clearing member of a CCP under resolution; (o) to transfer open positions and any related assets, including relevant title transfer and security financial collateral arrangements, set-off arrangements, and netting arrangements, from the account of a defaulting clearing member to a non-defaulting clearing member in a manner consistent with Article 48 of Regulation (EU) No 648/2012; (p) to enforce any existing and outstanding contractual obligations of the clearing members of the CCP under resolution or, where necessary to achieve the resolution objectives, refrain from enforcing such contractual obligations or otherwise deviate from the CCP’s operating rules; (q) to enforce any existing and outstanding obligations of the parent undertaking of the CCP under resolution including to provide the CCP with financial support by way of guarantees or credit lines; and (r) to require clearing members to provide further contributions in cash subject to the limit referred to in Article 31. Resolution authorities may exercise the powers referred to in the first subparagraph individually or in any combination. 2. Unless otherwise provided for in this Regulation and the Union State aid framework, the resolution authority shall not be subject to any of the following requirements where it exercises the powers referred to in paragraph 1: (a) requirement to obtain approval or consent from any public or private person; (b) requirements relating to the transfer of financial instruments, rights, obligations, assets or liabilities of a CCP under resolution or a bridge CCP; (c) requirement to notify any public or private person; (d) requirement to publish any notice or prospectus; (e) requirement to file or register any document with any other authority. Article 49 Ancillary powers 1. Where a power referred to in Article 48(1) of this Regulation is exercised, the resolution authority may also exercise any of the following ancillary powers: (a) subject to Article 67, to provide for a transfer to take effect free from any liability or encumbrance affecting the financial instruments, rights, obligations, assets or liabilities transferred; (b) to remove rights to acquire further instruments of ownership; (c) to require the relevant authority to discontinue or suspend the admission to trading on a regulated market, or the official listing, of any financial instruments issued by the CCP pursuant to Directive 2001/34/EC of the European Parliament and of the Council (25); (d) to provide for the purchaser or bridge CCP, pursuant to Articles 40 and 42 respectively, to be treated as if it were the CCP under resolution, for the purposes of any rights or obligations of, or actions taken by, the CCP under resolution, including any rights or obligations relating to participation in a market infrastructure; (e) to require the CCP under resolution or the purchaser or bridge CCP, where relevant, to provide the other with information and assistance; (f) to provide for the clearing member which is a recipient of any positions allocated to it by way of the powers in points (o) and (p) of Article 48(1) to assume any rights or obligations relating to participation in the CCP in relation to those positions; (g) to cancel or modify the terms of a contract to which the CCP under resolution is a party or substitute the purchaser or bridge CCP, in place of the CCP under resolution, as a party; (h) to modify or amend the operating rules of the CCP under resolution, including as regards its terms of access to clearing for its clearing members and other participants; (i) to transfer the membership of a clearing member from the CCP under resolution to a purchaser of the CCP or a bridge CCP. Any right of compensation provided for in this Regulation shall not be considered to be a liability or an encumbrance for the purposes of point (a) of the first subparagraph. 2. The resolution authority may provide for continuity arrangements necessary to ensure that the resolution action is effective and that the business transferred may be operated by the purchaser or bridge CCP. Those continuity arrangements may include: (a) the continuity of contracts entered into by the CCP under resolution, in order for the purchaser or bridge CCP to assume the rights and liabilities of the CCP under resolution relating to any financial instrument, right, obligation, asset or liability that has been transferred and to replace the CCP under resolution, expressly or implicitly, in all relevant contractual documents; (b) the replacement of the CCP under resolution by the purchaser or bridge CCP in any legal proceedings relating to any financial instrument, right, obligation, asset or liability that has been transferred. 3. The powers provided for in point (d) of paragraph 1, and point (b) of paragraph 2, of this Article shall not affect: (a) the right of an employee of the CCP to terminate a contract of employment; nor (b) subject to Articles 55, 56 and 57, the exercise of contractual rights of a party to a contract, including the right to terminate, where provided for in the terms of the contract, due to an act or omission by the CCP prior to the transfer, or by the purchaser or bridge CCP after the transfer. Article 50 Special management 1. The resolution authority may appoint one or more special managers to replace the board of a CCP under resolution. The special manager shall be of sufficiently good repute and shall have adequate expertise in financial services, risk management and clearing services in accordance with the second subparagraph of Article 27(2) of Regulation (EU) No 648/2012. 2. The special manager shall have all the powers of the shareholders and the board of the CCP. The special manager shall only exercise those powers under the control of the resolution authority. The resolution authority may limit the actions of the special manager or require prior consent for certain acts. The resolution authority shall make public the appointment referred to in paragraph 1 and the terms and conditions attached to that appointment. 3. The special manager shall be appointed for no more than one year. The resolution authority may renew that period where necessary to achieve the resolution objectives. 4. The special manager shall take all the measures necessary to promote the resolution objectives and implement resolution actions taken by the resolution authority. In the event of inconsistency or conflict, that statutory duty shall override any other duty of management in accordance with the statutes of the CCP or national law. 5. The special manager shall draw up reports for the appointing resolution authority at regular intervals set by the resolution authority and at the beginning and the end of the mandate. Those reports shall describe in detail the financial situation of the CCP and state the reasons for the measures taken. 6. The resolution authority may remove the special manager at any time. It shall in any case remove the special manager in the following cases: (a) where the special manager is failing to perform its duties in accordance with the terms and conditions set out by the resolution authority; (b) where the objectives of resolution would be better achieved by removing or replacing that special manager; or (c) where the conditions for the appointment are no longer fulfilled. Article 51 Power to require the provision of services and facilities 1. The resolution authority may require a CCP under resolution, any entity belonging to the same group as the CCP or any of the CCP’s clearing members to provide any services or facilities that are necessary to enable a purchaser or bridge CCP to operate effectively the business transferred to it. The first subparagraph shall apply regardless of whether an entity in the same group as the CCP or one of the CCP’s clearing members has entered into normal insolvency proceedings or is itself under resolution. 2. The resolution authority may enforce obligations imposed, pursuant to paragraph 1, by resolution authorities in other Member States where those powers are exercised in relation to entities belonging to the same group as the CCP under resolution, or in relation to the clearing members of that CCP. 3. The services and facilities referred to in paragraph 1 shall not include any form of financial support. 4. The services and facilities provided pursuant to paragraph 1 shall be provided: (a) on the same commercial terms on which they were provided to the CCP immediately before the resolution action was taken, where an agreement for the purposes of providing those services and facilities exists; or (b) on reasonable commercial terms, where there is no agreement for the purposes of providing those services and facilities or where that agreement has expired. Article 52 Power to enforce crisis prevention measures or resolution actions by other Member States 1. Where instruments of ownership, assets, rights, obligations or liabilities of a CCP under resolution are located in, or governed by the law of a Member State other than the Member State of the resolution authority, any transfer or resolution action in respect of those instruments, assets, rights, obligations or liabilities shall have effect in accordance with the law of that other Member State. 2. The resolution authority of a Member State shall be provided with all necessary assistance by the authorities of other relevant Member States to ensure that any instruments of ownership, assets, rights, obligations or liabilities are transferred to the purchaser or bridge CCP or any other resolution action becomes effective in accordance with the applicable national law. 3. Shareholders, creditors and third parties that are affected by the transfer of instruments of ownership, assets, rights, obligations or liabilities referred to in paragraph 1 shall not be entitled to prevent, challenge, or set aside that transfer under the law of the Member State where the assets are located or that governs the transfer of the instruments of ownership, assets, rights, obligations or liabilities. 4. Where the resolution authority of a Member State applies the resolution tools referred to in Articles 28 to 32, and the contracts, liabilities, instruments of ownership or debt instruments of the CCP under resolution include instruments, contracts or liabilities that are governed by the law of another Member State, or liabilities owed to creditors and contracts in respect of clearing members and, where applicable, their clients located in that other Member State, the relevant authorities in that other Member State shall ensure that any action resulting from those resolution tools takes effect. For the purposes of the first subparagraph, shareholders, creditors and clearing members and, where applicable, their clients affected by those resolution tools shall be entitled to challenge the reduction of the principal or payable amount of the instrument or liability or its conversion or restructuring, as the case may be, only under the law of the Member State of the resolution authority. 5. The following rights and safeguards shall be determined in accordance with the law of the Member State of the resolution authority: (a) the right for shareholders, creditors and third parties to appeal pursuant to Article 74 against the transfer of instruments of ownership, assets, rights, obligations or liabilities referred to in paragraph 1 of this Article; (b) the right for affected creditors to appeal pursuant to Article 74 against the reduction of the principal or payable amount or the conversion or restructuring of an instrument, liability or contract covered by paragraph 4 of this Article; and (c) the safeguards for partial transfers, as referred to in Chapter V, in relation to assets, rights, obligations or liabilities referred to in paragraph 1. Article 53 Power in respect of assets, contracts, rights, liabilities, obligations and instruments of ownership of persons located in or governed by the law of third countries 1. Where a resolution action concerns assets or contracts of persons located in a third country or instruments of ownership, rights, obligations or liabilities governed by the law of a third country, the resolution authority may require that: (a) the CCP under resolution and the recipient of those assets, contracts, instruments of ownership, rights, obligations or liabilities take all necessary steps to ensure that the action becomes effective; (b) the CCP under resolution holds the instruments of ownership, assets or rights or discharges the liabilities or obligations on behalf of the recipient until the action becomes effective; (c) the reasonable expenses of the recipient properly incurred in carrying out any action required under points (a) and (b) of this paragraph are reimbursed in any of the ways referred to in Article 27(10). 2. For the purposes of paragraph 1 of this Article, the resolution authority shall require the CCP to ensure the inclusion of a provision in its contracts and other agreements with clearing members and holders of instruments of ownership and debt instruments located in or governed by the law of third countries by which they agree to be bound by any action in respect of their assets, contracts, rights, obligations and liabilities taken by the resolution authority, including the application of Articles 28, 32, 55, 56 and 57. The resolution authority may require the CCP to ensure the inclusion of such a provision in its contracts and other agreements with holders of other liabilities located in or governed by the law of third countries. The resolution authority may require the CCP to provide it with a reasoned legal opinion by an independent legal expert confirming the legal enforceability and effectiveness of such provisions. 3. Where the resolution action referred to in paragraph 1 does not become effective, that action shall be void in relation to the instruments of ownership, assets, rights, obligations or liabilities concerned. Article 54 Exclusion of certain contractual terms in early intervention and resolution 1. A crisis prevention measure or a resolution action taken in accordance with this Regulation, or any event directly linked to the application of that action, shall not be deemed to be insolvency proceedings, an enforcement event or an event of default within the meaning of Directive 98/26/EC, Directive 2002/47/EC and Regulation (EU) No 575/2013 respectively provided that the substantive obligations under the contract, including payment and delivery obligations, and the provision of collateral, continue to be performed. For the purposes of the first subparagraph of this paragraph, third-country resolution proceedings recognised pursuant to Article 77, or otherwise where the resolution authority so decides, shall be considered a resolution action taken in accordance with this Regulation. 2. A crisis prevention measure or a resolution action referred to in paragraph 1 shall not be used to: (a) exercise any termination, suspension, modification, netting or set-off rights, including in relation to a contract entered into by any entity of the group to which the CCP belongs which includes cross-default provisions or obligations which are guaranteed or otherwise supported by any group entity; (b) obtain possession, exercise control or enforce any security over any property of the CCP concerned or any group entity in relation to a contract which includes cross-default provisions; or (c) affect any contractual rights of the CCP concerned or any group entity in relation to a contract which includes cross-default provisions. Article 55 Power to suspend certain obligations 1. The resolution authority may suspend any payment or delivery obligations of both counterparties to any contract entered into by a CCP under resolution from the publication of the notice of suspension in accordance with Article 72 until the end of the working day which follows that publication. For the purposes of the first subparagraph, the end of the working day shall mean midnight in the Member State of the resolution authority. 2. Where a payment or delivery obligation would have been due during the suspension period, the payment or delivery obligation shall be due immediately upon expiry of the suspension period. 3. The resolution authority shall not exercise the power referred to in paragraph 1 to payment and delivery obligations owed to systems or operators of systems designated for the purposes of Directive 98/26/EC, other CCPs, and central banks. Article 56 Power to restrict the enforcement of security interests 1. The resolution authority may prevent secured creditors of a CCP under resolution from enforcing security interests in relation to any assets of that CCP under resolution from the publication of the notice of the restriction in accordance with Article 72 until the end of the working day which follows that publication. For the purposes of the first subparagraph, the end of the working day shall mean midnight in the Member State of the resolution authority. 2. The resolution authority shall not exercise the power referred to in paragraph 1 in relation to any security interest of systems or operators of systems designated for the purposes of Directive 98/26/EC, other CCPs, and central banks over assets pledged or provided by way of margin or collateral by the CCP under resolution. Article 57 Power to temporarily suspend termination rights 1. The resolution authority may suspend the termination rights of any party to a contract with a CCP under resolution from the publication of the notice of the termination in accordance with Article 72 until the end of the working day which follows that publication, provided that the payment and delivery obligations and the provision of collateral continue to be performed. For the purposes of the first subparagraph, the end of the working day shall mean midnight in the Member State of the resolution. 2. The resolution authority shall not exercise the power referred to in paragraph 1 in relation to systems or operators of systems designated for the purposes of Directive 98/26/EC, other CCPs and central banks. 3. A party to a contract may exercise a termination right under that contract before the end of the period referred to in paragraph 1 where that party receives notice from the resolution authority that the rights and liabilities covered by the contract shall not be: (a) transferred to another entity; or (b) subject to write-down, conversion, or the application of a resolution tool to allocate losses or positions. 4. Where the notice referred to in paragraph 3 of this Article has not been given, termination rights may be exercised on the expiry of the period of suspension, subject to Article 54, as follows: (a) where the rights and liabilities covered by the contract have been transferred to another entity, a counterparty may exercise termination rights in accordance with the terms of that contract only if the recipient entity causes the enforcement event to occur or continue; (b) where the rights and liabilities covered by the contract remain with the CCP, a counterparty may exercise termination rights in accordance with the conditions for termination as set out in the contract between the CCP and the relevant counterparty only if the enforcement event occurs or continues after the expiry of a suspension under paragraph 1 of this Article. Article 58 Power to exercise control over the CCP 1. The resolution authority may exercise control over the CCP under resolution to: (a) manage the activities and services of the CCP, exercising the powers of its shareholders and board; (b) consult the risk committee; (c) manage and dispose of the assets and property of the CCP under resolution. The control referred to in the first subparagraph of this paragraph may be exercised directly by the resolution authority or indirectly by a special manager appointed by the resolution authority in accordance with Article 50(1). 2. Where the resolution authority exercises control over the CCP, the resolution authority shall not be deemed to be a shadow director or de facto director under national law. Article 59 Exercise of powers by the resolution authorities Without prejudice to Article 74, resolution authorities shall take resolution actions through executive orders in accordance with national administrative competences and procedures. CHAPTER V Safeguards Article 60 ‘No creditor worse off’ principle Where the resolution authority applies one or more resolution tools, it shall ensure that shareholders, clearing members and other creditors do not incur greater losses than they would have incurred had the resolution authority not taken resolution action in relation to the CCP at the time the resolution authority considered that the conditions for resolution pursuant to Article 22(1) were met and had the CCP instead been wound up under normal insolvency proceedings, following the full application of the applicable contractual obligations and other arrangements in its operating rules. Article 61 Valuation for the application of the ‘no creditor worse off’ principle 1. For the purposes of assessing compliance with the ‘no creditor worse off’ principle as laid down in Article 60, the resolution authority shall ensure that a valuation is carried out by an independent person as soon as possible after the resolution action or actions have been effected. 2. The valuation referred to in paragraph 1 shall include: (a) the treatment that shareholders, clearing members and other creditors would have received had the resolution authority not taken resolution action in relation to the CCP at the time the resolution authority considered that the conditions for resolution pursuant to Article 22(1) were met and had the CCP instead been wound up under normal insolvency proceedings, following the full application of the applicable contractual obligations and other arrangements in its operating rules; (b) the actual treatment that shareholders, clearing members and other creditors, have received in the resolution of the CCP; (c) whether there is any difference between the treatment referred to in point (a) of this paragraph and the treatment referred to in point (b) of this paragraph. 3. For the purposes of calculating the treatments referred to in point (a) of paragraph 2, the valuation referred to in paragraph 1 shall: (a) disregard any provision of extraordinary public financial support to the CCP under resolution or central bank emergency liquidity assistance or any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest terms; (b) be based on the losses that would have been realistically incurred by clearing members and other creditors, had the CCP been wound up under normal insolvency proceedings, following the full application of the applicable contractual obligations and other arrangements in its operating rules; (c) take into account a commercially reasonable estimate of the direct replacement costs, including any additional margin requirements, incurred by the clearing members to reopen within an appropriate period their comparable net positions in the market by considering effective market conditions, including market depth and ability of the market to transact the relevant volume of such net positions within that period; and (d) be based on the CCP’s own pricing methodology unless such methodology for price determination does not reflect the effective market conditions. The length of the period referred to in point (c) of the first subparagraph shall reflect the implications of the applicable insolvency law and the characteristics of the relevant net positions. 4. The valuation referred to in paragraph 1 of this Article shall be distinct from the valuation carried out under Article 24(3). 5. ESMA, taking into account the regulatory technical standards adopted pursuant to Articles 49(5) and 74(4) of Directive 2014/59/EU, shall develop draft regulatory technical standards specifying the methodology for carrying out the valuation referred to in paragraph 1 of this Article including the calculation of the losses following liquidation resulting from the costs referred to in point (c) of the first subparagraph of paragraph 3 of this Article had the CCP been wound up under normal insolvency proceedings, following the full application of the applicable contractual obligations and other arrangements in its operating rules. ESMA shall submit those draft regulatory standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 62 Safeguard for shareholders, clearing members and other creditors Where, in accordance with the valuation carried out under Article 61, any shareholder, clearing member or other creditor has incurred greater losses than it would have incurred had the resolution authority not taken resolution action in relation to the CCP and had the CCP instead been wound up under normal insolvency proceedings, following the full application of the applicable contractual obligations or other arrangements in its operating rules, that shareholder, clearing member or other creditor shall be entitled to the payment of the difference. Article 63 Safeguard for clients and indirect clients 1. Contractual arrangements allowing clearing members to pass on to their clients the negative consequences of the resolution tools shall also include, on an equivalent and proportionate basis, the right of clients to any recompense or compensation clearing members receive in accordance with Article 27(6) or any cash equivalent of such recompense or compensation or any proceeds they receive following a claim made in accordance with Article 62 to the extent that such proceeds are related to client positions. Those provisions shall also apply to the contractual arrangements by clients and indirect clients offering indirect clearing services to their clients. 2. ESMA shall develop draft regulatory technical standards in order to specify, in a transparent manner, to the extent allowed by confidentiality of contractual arrangements, the conditions under which the passing on of compensation, cash equivalent of such compensation or any proceeds referred to in the paragraph 1 is required, and the conditions under which it is to be considered proportionate. ESMA shall submit those draft regulatory technical standards to the Commission by 12 February 2022. The Commission is empowered to supplement this Regulation by adopting the regulatory technical standards referred to in the first subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 64 Recoupment of payments The resolution authority shall recover, to the largest extent possible, any reasonable expenses incurred in connection with a payment as referred to in Article 62 in any of the following ways: (a) from the CCP under resolution, as a preferred creditor; (b) from any consideration paid by the purchaser where the sale of business tool has been applied; (c) from any proceeds generated as a result of the termination of the bridge CCP, as a preferred creditor. Article 65 Safeguard for counterparties in partial transfers The protections provided for in Articles 66, 67 and 68 shall apply in the following circumstances: (a) where the resolution authority transfers some but not all of the assets, rights, obligations or liabilities of a CCP under resolution to another entity or, in the application of a resolution tool, from a bridge CCP to a purchaser; and (b) where the resolution authority exercises the powers referred to in point (g) of Article 49(1). Article 66 Protection for financial collateral, set off and netting arrangements The resolution authority shall ensure that the application of a resolution tool, other than the position allocation tool referred to in Article 29, does not result in transferring some but not all of the rights and liabilities under a title transfer financial collateral arrangement, a set-off arrangement or a netting arrangement between a CCP under resolution and other parties to the arrangements, or in modifying or terminating the rights and liabilities under those arrangements through the use of ancillary powers. The arrangements referred to in the first subparagraph shall include any arrangement to which the parties are entitled to set-off or net those rights and liabilities. Article 67 Protection for security arrangements The resolution authority shall ensure that the application of a resolution tool does not result in any of the following with respect to security arrangements between a CCP under resolution and other parties to those arrangements: (a) the transfer of assets against which the liability is secured unless that liability and benefit of the security are also transferred; (b) the transfer of a secured liability unless the benefit of the security is also transferred; (c) the transfer of the benefit of the security unless the secured liability is also transferred; (d) the modification or termination of a security arrangement through the use of ancillary powers, if the effect of that modification or termination is that the liability ceases to be secured. Article 68 Protection for structured finance arrangements and covered bonds The resolution authority shall ensure that the application of a resolution tool does not result in any of the following with respect to structured finance arrangements, including covered bonds: (a) the transfer of some, but not all, of the assets, rights and liabilities which constitute or form part of a structured finance arrangement to which the CCP under resolution is a party; (b) the termination or modification through the use of ancillary powers of the assets, rights and liabilities which constitute or form part of a structured finance arrangement to which the CCP under resolution is a party. For the purposes of the first subparagraph, structured finance arrangements shall include securitisations and instruments used for hedging purposes which form an integral part of the cover pool and which according to national law are secured in a way similar to the covered bonds, which involve the granting and holding of security by a party to the arrangement or a trustee, agent or nominee. Article 69 Partial transfers: protection of trading, clearing and settlement systems 1. The resolution authority shall ensure that the application of a resolution tool does not affect the operation of systems and rules of systems covered by Directive 98/26/EC, where the resolution authority: (a) transfers some but not all of the assets, rights, obligations or liabilities of a CCP under resolution to another entity; (b) cancels or amends the terms of a contract to which the CCP under resolution is a party or substitutes a purchaser or bridge CCP as a party. 2. For the purposes of paragraph 1 of this Article, the resolution authority shall ensure that the application of a resolution tools does not result in any of the following outcomes: (a) revoking a transfer order in accordance with Article 5 of Directive 98/26/EC; (b) affecting the enforceability of transfer orders and netting as required by Articles 3 and 5 of Directive 98/26/EC; (c) affecting the use of funds, securities or credit facilities as required by Article 4 of Directive 98/26/EC; (d) affecting the protection of collateral security as required by Article 9 of Directive 98/26/EC. CHAPTER VI Procedural obligations Article 70 Notification requirements 1. The CCP shall notify the competent authority where it considers that it is failing or likely to fail as referred to in Article 22(2). 2. The competent authority shall inform the resolution authority of any notifications received under paragraph 1, and of any recovery or other measures in accordance with Title IV that the competent authority requires the CCP to take. The competent authority shall inform the resolution authority of any emergency situation referred to in Article 24 of Regulation (EU) No 648/2012 relating to a CCP and of any notification received in accordance with Article 48 of that Regulation. 3. Where a competent authority or resolution authority determines that the conditions referred to in points (a) and (b) of Article 22(1) or in Article 22(3) are met in relation to a CCP, it shall notify without undue delay the following bodies: (a) the competent authority or resolution authority for that CCP; (b) the competent authority for the parent undertaking of the CCP; (c) the central bank; (d) the competent ministry; (e) the ESRB and the designated national macro-prudential authority; and (f) the supervisory college and resolution college for that CCP. Article 71 Decision of the resolution authority 1. After a notification from the competent authority pursuant to Article 70(3), the resolution authority shall determine whether any resolution action is needed. 2. The decision whether or not to take resolution action in relation to a CCP shall contain information on the following: (a) the resolution authority’s assessment of whether the CCP meets the conditions for resolution; and (b) any action that the resolution authority intends to take, including the decision to apply for winding up, the appointment of an administrator or any other measure under applicable normal insolvency proceedings. Article 72 Procedural obligations of resolution authorities 1. The resolution authority shall notify the resolution college of the resolution actions it intends to take. That notification shall also indicate whether the resolution actions deviate from the resolution plan. As soon as practicable after taking a resolution action, the resolution authority shall notify all of the following: (a) the CCP under resolution; (b) the resolution college; (c) the designated national macroprudential authority and the ESRB; (d) the Commission, ECB, and EIOPA; and (e) the operators of the systems covered by Directive 98/26/EC in which the CCP under resolution participates. 2. The notification referred to in the second subparagraph of paragraph 1 shall include a copy of any order or instrument by which the relevant action is taken and indicate the date from which the resolution action is effective. The notification to the resolution college pursuant to second subparagraph of paragraph 1 shall provide the reasons for any deviation from the resolution plan. 3. A copy of the order or instrument by which the resolution action is taken, or a notice summarising the effects of the resolution action and, if applicable, the terms and period of suspension or restriction referred to in Articles 55, 56 and 57 of this Regulation, shall be published on all of the following: (a) the website of the resolution authority; (b) the website of the competent authority, if different from the resolution authority, and the website of ESMA; (c) the website of the CCP under resolution; and (d) where the instruments of ownership or debt instruments of the CCP under resolution are admitted to trading on a regulated market, the means used for the disclosure of regulated information concerning the CCP under resolution in accordance with Article 21(1) of Directive 2004/109/EC of the European Parliament and of the Council (26). 4. Where the instruments of ownership or debt instruments are not admitted to trading on a regulated market, the resolution authority shall ensure that the documents providing proof of the order referred to in paragraph 3 are sent to the holders of the instruments of ownership and creditors of the CCP under resolution that are known through the registers or databases of the CCP under resolution which are available to the resolution authority. Article 73 Confidentiality 1. The requirements of professional secrecy shall be binding in respect of the following persons: (a) resolution authorities; (b) competent authorities, ESMA and EBA; (c) competent ministries; (d) special managers or temporary administrators appointed under this Regulation; (e) potential acquirers that are contacted by the competent authorities or solicited by the resolution authorities, irrespective of whether that contact or solicitation was made as preparation for the application of the sale of business tool, and irrespective of whether the solicitation resulted in an acquisition; (f) auditors, accountants, legal and professional advisors, valuers and other experts directly or indirectly engaged by the resolution authorities, competent authorities, competent ministries or by the potential acquirers referred to in point (e); (g) central banks and other authorities involved in the resolution process; (h) a bridge CCP; (i) the senior management and members of the board of the CCP, and employees of the bodies or entities referred to in points (a) to (k) before, during and after their appointment; (j) all other members of the resolution college not referred to in points (a), (b), (c) and (g); and (k) any other persons who provide or have provided services directly or indirectly, permanently or occasionally, to persons referred to in points (a) to (j). 2. With a view to ensuring that the confidentiality requirements laid down in paragraphs 1 and 3 are complied with, the persons referred to in points (a), (b), (c), (g), (h) and (j) of paragraph 1 shall ensure that there are internal rules in place, including rules to secure secrecy of information between persons directly involved in the resolution process. 3. The persons referred to in paragraph 1 shall be prohibited from disclosing confidential information received during the course of their professional activities or from a competent authority or resolution authority in connection with their functions under this Regulation, to any person or authority unless it is in the exercise of their functions under this Regulation, or in summary or aggregate form such that individual CCPs cannot be identified, or with the express and prior consent of the authority or the CCP which provided the information. Before disclosing any type of information, the persons referred to in paragraph 1 shall assess the effects that the disclosure may have on the public interest as regards financial, monetary or economic policy, on the commercial interests of natural and legal persons, on the purpose of inspections, on investigations and on audits. The procedure for checking the effects of disclosing information shall include a specific assessment of the effects of any disclosure of the contents and details of recovery and resolution plans as referred to in Articles 9 and 12 and the result of any assessment carried out under Articles 10 and 15. Any person or entity referred to in paragraph 1 shall be subject to civil liability in the event of an infringement of this Article, in accordance with national law. 4. By way of derogation from paragraph 3, the persons referred to in paragraph 1 may exchange confidential information with any of the following provided that the recipient is subject to requirements of confidentiality for the purposes of that exchange: (a) any other person where necessary for the purposes of planning or carrying out a resolution action; (b) parliamentary enquiry committees in their Member State, courts of auditors in their Member State and other entities in charge of enquiries in their Member State; (c) national authorities responsible for overseeing payment systems, authorities responsible for normal insolvency proceedings, authorities entrusted with the public duty of supervising other financial sector entities, authorities responsible for the supervision of financial markets and insurance undertakings and inspectors acting on their behalf, authorities responsible for maintaining the stability of the financial system in Member States through the use of macroprudential rules, authorities responsible for protecting the stability of the financial system, and persons responsible for carrying out statutory audits. 5. This Article shall not prevent: (a) employees and experts of the bodies or entities referred to in points (a) to (g), and in point (j), of paragraph 1 from sharing information among themselves within each body or entity; (b) resolution authorities and competent authorities, including their employees and experts, from sharing information with each other and with other Union resolution authorities, other Union competent authorities, competent ministries, central banks, authorities responsible for normal insolvency proceedings, authorities responsible for maintaining the stability of the financial system in Member States through the use of macroprudential rules, persons charged with carrying out statutory audits of accounts, EBA, ESMA, or, subject to Article 80, third-country authorities that carry out equivalent functions to resolution authorities, or, subject to strict confidentiality requirements, to a potential acquirer for the purposes of planning or carrying out a resolution action. 6. This Article shall be without prejudice to national law concerning the disclosure of information for the purpose of legal proceedings in criminal or civil cases. CHAPTER VII Right of appeal and exclusion of other actions Article 74 Ex-ante judicial approval and rights of appeal 1. A decision to take a crisis prevention measure or resolution action may be subject to ex-ante judicial approval where provided in national law, where the procedure relating to that approval and the court’s consideration are expeditious. 2. All persons affected by a decision to take a crisis prevention measure or a decision to exercise any power, other than a resolution action, shall have the right of appeal against that decision. 3. All persons affected by a decision to take a resolution action shall have the right of appeal against that decision. 4. The right of appeal referred to in paragraph 3 shall be subject to the following conditions: (a) the lodging of an appeal shall not entail any automatic suspension of the effects of the challenged decision; (b) the decision of the resolution authority shall be immediately enforceable and it shall give rise to a rebuttable presumption that a suspension of its enforcement would be against the public interest; and (c) the procedure relating to the appeal shall be expeditious. 5. The court shall use the economic assessments of the facts carried out by the resolution authority as a basis for its own assessment. 6. Where necessary to protect the interests of third parties acting in good faith who have acquired instruments of ownership, assets, rights, obligations or liabilities of a CCP under resolution by virtue of a resolution action, the annulment of a decision of a resolution authority shall not affect any subsequent administrative acts or transactions concluded by the resolution authority concerned which were based on the annulled decision. For the purposes of the first subparagraph, the remedies available to the applicant where a decision of the resolution authority is annulled shall be limited to compensation for the loss suffered as a result of that decision. Article 75 Restrictions on other proceedings 1. Normal insolvency proceedings shall not be commenced in relation to a CCP except at the initiative of the resolution authority or with its consent in accordance with paragraph 3. 2. Competent authorities and resolution authorities shall be notified without delay of any application for the opening of normal insolvency proceedings in relation to a CCP, irrespective of whether the CCP is under resolution or a decision has been made public in accordance with Article 72(3). 3. The authorities responsible for normal insolvency proceedings shall only commence those proceedings after the resolution authority has notified them of its decision not to take any resolution action in relation to the CCP or where no notification has been received within seven days of the notification referred to in paragraph 2. Where necessary for the effective application of the resolution tools and powers, resolution authorities may request the court to apply a stay on any judicial action or proceeding in which a CCP under resolution is or may become a party for an appropriate period in accordance with the resolution objectives. TITLE VI RELATIONS WITH THIRD COUNTRIES Article 76 Agreements with third countries 1. In accordance with Article 218 TFEU, the Commission may submit to the Council recommendations for the negotiation of agreements with one or more third countries regarding the means of cooperation between the resolution authorities and the relevant third-country authorities in connection with recovery and resolution planning in relation to CCPs and third-country CCPs, with regard to the following situations: (a) where a third-country CCP provides services or has subsidiaries in one or more Member States; (b) where a CCP established in a Member State provides services or has one or more subsidiaries in a third country. 2. The agreements referred to in paragraph 1 of this Article shall, in particular, seek to ensure the establishment of processes and arrangements for cooperation in carrying out the tasks and exercising the powers referred to in Article 79, including the exchange of information necessary for those purposes. Article 77 Recognition and enforcement of third-country resolution proceedings 1. This Article shall apply in respect of third-country resolution proceedings unless and until an international agreement as referred to in Article 76(1) enters into force with the relevant third country. It shall also apply following the entry into force of an international agreement as referred to in Article 76(1) with the relevant third country to the extent that recognition and enforcement of third-country resolution proceedings is not governed by that agreement. 2. Relevant national authorities shall recognise third-country resolution proceedings relating to a third-country CCP in any of the following cases: (a) the third-country CCP provides services, or has subsidiaries established, in one or more Member States; (b) the third-country CCP has assets, rights, obligations or liabilities located in one or more Member States or are governed by the law of those Member States. Relevant national authorities shall ensure the enforcement of the recognised third-country resolution proceedings in accordance with their national law. 3. The relevant national authorities shall at least have the power to do the following: (a) exercise the resolution powers in relation to the following: (i) assets of a third-country CCP that are located in their Member State or governed by the law of their Member State; and (ii) rights or liabilities of a third-country CCP that are booked in their Member State or governed by the law of their Member State, or where claims in relation to such rights and liabilities are enforceable in their Member State; (b) perfect, including to require another person to take action to perfect, a transfer of instruments of ownership in a subsidiary established in the designating Member State; (c) exercise the powers in Article 55, 56 and 57 in relation to the rights of any party to a contract with an entity referred to in paragraph 2 of this Article, where such powers are necessary in order to enforce third-country resolution proceedings; and (d) render unenforceable any right to terminate, liquidate or accelerate contracts, or affect the contractual rights, of entities referred to in paragraph 2 and other group entities, where such a right arises from resolution action taken in respect of the third-country CCP, whether by the third-country resolution authority itself or otherwise pursuant to legal or regulatory requirements as to resolution arrangements in that country, provided that the substantive obligations under the contract, including payment and delivery obligations, and provision of collateral, continue to be performed. 4. The recognition and enforcement of third-country resolution proceedings shall be without prejudice to any normal insolvency proceedings applicable under national law. Article 78 Right to refuse recognition or enforcement of third-country resolution proceedings By way of derogation from Article 77(2), the relevant national authorities may refuse to recognise or to enforce third-country resolution proceedings in any of the following cases: (a) the third-country resolution proceedings would have adverse effects on financial stability in their Member State; (b) creditors, clearing members and, where applicable, their clients located in their Member State would not receive the same treatment as third-country creditors, clearing members and, where applicable, their clients with similar legal rights under the third-country home resolution proceedings; (c) recognition or enforcement of the third-country resolution proceedings would have material fiscal implications for their Member State; (d) the recognition or enforcement would be contrary to national law. Article 79 Cooperation with third-country authorities 1. This Article shall apply in respect of cooperation with a third country unless and until an international agreement as referred to in Article 76(1) enters into force with the relevant third country. It shall also apply following the entry into force of an international agreement provided for in Article 76(1) with the relevant third country to the extent that the subject matter of this Article is not governed by that agreement. 2. Competent authorities or resolution authorities, where appropriate, shall conclude cooperation arrangements with the following relevant third-country authorities, taking into account existing cooperation arrangements established pursuant to Article 25(7) of Regulation (EU) No 648/2012: (a) where a third-country CCP provides services or has subsidiaries in one or more Member States, the relevant third-country authorities where the CCP is established; (b) where a CCP provides services in or has one or more third-country subsidiaries, the relevant third-country authorities where those services are provided or where the subsidiaries are established. 3. The cooperation arrangements referred to in paragraph 2 of this Article shall establish processes and arrangements between the participating authorities for sharing the necessary information for, and cooperating in, carrying out the following tasks and exercising the following powers in relation to CCPs referred to in points (a) and (b) of that paragraph or groups including such CCPs: (a) the drawing up of resolution plans in accordance with Article 12 and similar requirements under the law of the relevant third countries; (b) the assessment of the resolvability of such institutions and groups, in accordance with Article 15 and similar requirements under the law of the relevant third countries; (c) the application of powers to address or remove impediments to resolvability pursuant to Article 16 and any similar powers under the law of the relevant third countries; (d) the application of early intervention measures pursuant to Article 18 and similar powers under the law of the relevant third countries; and (e) the application of resolution tools and exercise of resolution powers and similar powers conferred upon the relevant third-country authorities. 4. Cooperation arrangements concluded between resolution authorities and competent authorities of Member States and third countries pursuant to paragraph 2 may include provisions on the following matters: (a) the exchange of information necessary for the preparation and maintenance of resolution plans; (b) consultation and cooperation in drawing up resolution plans, including principles for the exercise of powers under Article 77 and similar powers under the law of the relevant third countries; (c) the exchange of information necessary for the application of resolution tools and exercise of resolution powers and similar powers under the law of the relevant third countries; (d) early warning to or consultation of parties to the cooperation arrangement before taking any significant action under this Regulation or relevant third-country law affecting the CCP or group to which the arrangement relates; (e) the coordination of public communication in the case of joint resolution actions; (f) procedures and arrangements for the exchange of information and cooperation under points (a) to (e) of this paragraph, including, where appropriate, through the establishment and operation of crisis management groups. In order to ensure the common, uniform and consistent application of paragraph 3, ESMA shall issue guidelines on the types and content of the provisions referred to in this paragraph by 12 August 2022. 5. Resolution authorities and competent authorities shall notify ESMA of any cooperation agreements that they have concluded in accordance with this Article. Article 80 Exchange of confidential information 1. Resolution authorities, competent authorities, competent ministries and, where applicable, other relevant national authorities shall exchange confidential information, including recovery plans, with relevant third-country authorities only if the following conditions are met: (a) those third-country authorities are subject to requirements and standards of professional secrecy at least considered to be equivalent, in the opinion of all the authorities concerned, to those imposed by Article 73; and (b) the information is necessary for the performance by the relevant third-country authorities of their functions under national law that are comparable to those under this Regulation and is not used for any other purposes. 2. In so far as the exchange of information relates to personal data, the handling and transmission of such personal data to third-country authorities shall be governed by the applicable Union and national data protection law. 3. Where confidential information originates in another Member State, resolution authorities, competent authorities and competent ministries shall not disclose that information to relevant third-country authorities unless the following conditions are met: (a) the relevant authority of the Member State where the information originated agrees to that disclosure; and (b) the information is disclosed only for the purposes permitted by the authority referred to in point (a). 4. For the purposes of this Article, information is deemed to be confidential if it is subject to confidentiality requirements under Union law. TITLE VII ADMINISTRATIVE MEASURES AND PENALTIES Article 81 Administrative penalties and other administrative measures 1. Without prejudice to the right of Member States to provide for and impose criminal penalties, Member States shall lay down rules on administrative penalties and other administrative measures applicable where this Regulation has not been complied with, and shall take all measures necessary to ensure that they are implemented. Where Member States decide not to lay down rules on administrative penalties for infringements which are subject to national criminal law, they shall communicate to the Commission and to ESMA the relevant criminal law provisions. The administrative penalties and other administrative measures shall be effective, proportionate and dissuasive. By 12 August 2022, Member States shall notify, in detail, the rules referred to in the first and second subparagraphs of this paragraph to the Commission and to ESMA. They shall notify the Commission and ESMA without delay of any subsequent amendments thereto. 2. Member States shall ensure that, where the obligations referred to in paragraph 1 apply to CCPs and clearing members, in the event of an infringement, the administrative penalties or other administrative measures referred to in that paragraph can be applied, subject to the conditions laid down in national law, to the board and the senior management of CCPs and of clearing members and to other natural persons who under national law are responsible for the infringement. 3. The powers to impose administrative penalties or other administrative measures provided for in this Regulation shall be attributed to resolution authorities or, where different, to competent authorities, depending on the type of infringement. Resolution authorities and competent authorities shall have all information-gathering and investigatory powers that are necessary for the exercise of their respective functions. In the exercise of their powers to impose penalties, resolution authorities and competent authorities shall cooperate closely to ensure that administrative penalties or other administrative measures produce the desired results and coordinate their action when dealing with cross-border cases. 4. Resolution authorities and competent authorities shall exercise their powers to impose administrative penalties or other administrative measures in accordance with this Regulation and national law in any of the following ways: (a) directly; (b) in collaboration with other authorities; (c) under their responsibility by delegation to such authorities; (d) by application to the competent judicial authorities. Article 82 Specific provisions 1. Member States shall ensure that their laws, regulations and administrative provisions provide for penalties and other administrative measures at least in respect of the following situations: (a) failure to draw up, maintain and update recovery plans, in breach of Article 9; (b) failure to provide all the information necessary for the development of resolution plans, in breach of Article 13; and (c) failure of the CCP to notify the competent authority when the CCP is failing or likely to fail, in breach of Article 70(1). 2. Member States shall ensure that, in the cases referred to in paragraph 1, the administrative penalties and other administrative measures that can be applied include at least the following: (a) a public statement which indicates the natural person, CCP, or other legal person responsible and the nature of the infringement; (b) an order requiring the natural or legal person responsible to cease the conduct and to desist from a repetition of that conduct; (c) a temporary ban against the members of the senior management of the CCP or any other natural person, who is held responsible, to exercise functions in a CCP; (d) in the case of a legal person, administrative fines of up to 10 % of the total annual turnover of that legal person in the preceding business year. Where the legal person is a subsidiary of a parent undertaking, the relevant turnover shall be the turnover resulting from the consolidated accounts of the ultimate parent undertaking in the preceding business year; (e) in the case of a natural person, administrative fines of up to EUR 5 000 000, or in the Member States where the euro is not the official currency, the corresponding value in the national currency on 11 February 2021; and (f) administrative fines of up to twice the amount of the benefit derived from the infringement where that benefit can be determined. Article 83 Publication of administrative penalties or other administrative measures 1. Resolution authorities or competent authorities shall publish on their official website any administrative penalties or administrative measures imposed by them for infringements of this Regulation where such penalties or measures have not been the subject of an appeal or where the right of appeal has been exhausted. Such publication shall take place without undue delay after the natural or legal person is informed of that penalty or measure and shall include information on the type and nature of the infringement and the identity of the natural or legal person on whom the penalty or measure is imposed. Where Member States permit publication of administrative penalties or other administrative measures against which there is an appeal, resolution authorities and competent authorities shall, without undue delay, publish on their official websites information on the status of that appeal and the outcome thereof. 2. Resolution authorities and competent authorities shall publish the administrative penalties or other administrative measures imposed by them on an anonymous basis, in a manner which is in accordance with national law, in any of the following circumstances: (a) where the administrative penalty or other administrative measure is imposed on a natural person and publication of personal data is shown to be disproportionate by an obligatory prior assessment of the proportionality of such publication; (b) where publication would jeopardise the stability of financial markets or an ongoing criminal investigation or proceedings; (c) where publication would cause, insofar as it can be determined, disproportionate damage to the CCP or natural persons involved. Alternatively, in such cases, the publication of the data in question may be postponed for a reasonable period, if it is foreseeable that the reasons for anonymous publication will cease to exist within that period. 3. Resolution authorities and competent authorities shall ensure that any publication in accordance with this Article shall remain on their official website for a period of at least five years. Personal data contained in the publication shall only be kept on the official website of the resolution authority or the competent authority for the period which is necessary in accordance with applicable data protection rules. 4. By 12 August 2022, ESMA shall submit a report to the Commission on the publication of administrative penalties and other administrative measures by Member States on an anonymous basis as provided for under paragraph 2 and in particular whether there have been significant divergences between Member States in that respect. That report shall also address any significant divergences in the duration of publication of administrative penalties or other administrative measures under national law of Member States for publication of administrative penalties and other administrative measures. Article 84 Maintenance of central database by ESMA 1. Subject to the professional secrecy requirements referred to in Article 73, resolution authorities and competent authorities shall inform ESMA of all administrative penalties imposed by them under Article 81 and of the status of any appeal against such penalties and the outcome thereof. 2. ESMA shall maintain a central database of administrative penalties reported to it solely for the purpose of exchange of information between resolution authorities which shall be accessible to resolution authorities only and shall be updated on the basis of the information provided by resolution authorities. 3. ESMA shall maintain a central database of administrative penalties reported to it solely for the purpose of exchange of information between competent authorities which shall be accessible to competent authorities only and shall be updated on the basis of the information provided by competent authorities. 4. ESMA shall maintain a webpage on its existing website with links to each resolution authority’s publication of administrative penalties and each competent authority’s publication of administrative penalties under Article 83 and indicate the period for which each Member State publishes penalties. Article 85 Exercise of powers to impose administrative penalties and other administrative measures and their effective application by competent authorities and resolution authorities Member States shall ensure that, when determining the type of administrative penalties or other administrative measures and the level of administrative fines, the competent authorities and resolution authorities take into account all relevant circumstances, including where appropriate: (a) the gravity and the duration of the infringement; (b) the degree of responsibility of the natural or legal person responsible; (c) the financial strength of the natural or legal person responsible, for example, as indicated by the total turnover of the responsible legal person or the annual income of the responsible natural person; (d) the amount of profits gained or losses avoided by the natural or legal person responsible, insofar as they can be determined; (e) the losses for third parties caused by the infringement, insofar as they can be determined; (f) the level of cooperation of the natural or legal person responsible with the competent authority and the resolution authority; (g) previous infringements by the natural or legal person responsible; (h) any potential systemic consequences of the infringement. TITLE VIII AMENDMENTS TO REGULATIONS (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 AND (EU) 2015/2365 AND DIRECTIVES 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU AND (EU) 2017/1132 Article 86 Amendments to Regulation (EU) No 1095/2010 Regulation (EU) No 1095/2010 is amended as follows: (1) in point (3) of Article 4, the following point is added: ‘(iv) with regard to Regulation (EU) 2021/23 of the European Parliament and of the Council (*), a resolution authority as defined in point (3) of Article 2 of that Regulation. (*) Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (OJ L 022, 22.1.2021, p. 1).’;" (2) in Article 40(5), the following subparagraph is added: ‘For the purpose of acting within the scope of Regulation (EU) 2021/23, the member of the Board of Supervisors referred to in point (b) of paragraph 1 may, where appropriate, be accompanied by a representative from the resolution authority in each Member State, who shall be non-voting.’. Article 87 Amendments to Regulation (EU) No 648/2012 Regulation (EU) No 648/2012 is amended as follows: (1) the following Article is inserted: ‘Article 6b Suspension of clearing obligation in the case of resolution 1. Where a CCP meets the conditions under Article 22 of Regulation (EU) 2021/23 of the European Parliament and of the Council (*), the resolution authority of the CCP designated under Article 3(1) of that Regulation or the competent authority designated in accordance with Article 22(1) of this Regulation may, on their own initiative or at the request of a competent authority responsible for the supervision of a clearing member of the CCP under resolution, request that the Commission suspend the clearing obligation referred to in Article 4(1) of this Regulation for specific classes of OTC derivatives or for a specific type of counterparty where the following conditions are met: (a) the CCP under resolution is authorised to clear the specific classes of OTC derivatives subject to the clearing obligation for which the suspension is requested; and (b) the suspension of the clearing obligation for those specific classes of OTC derivatives or for a specific type of counterparty is necessary to avoid or address a serious threat to financial stability or to the orderly functioning of financial markets in the Union in connection with the resolution of the CCP, and that suspension is proportionate to those aims. The request referred to in the first subparagraph shall be accompanied by evidence that the conditions laid down in points (a) and (b) of that subparagraph are met. The authority referred to in the first subparagraph shall notify its reasoned request to ESMA and the ESRB at the same time that the request is submitted to the Commission. 2. ESMA shall, within 24 hours of notification of the request from the authority referred to in the first subparagraph of paragraph 1 of this Article, and, to the extent possible, after consulting the ESRB, issue an opinion on the intended suspension taking into account the necessity to avoid or address a serious threat to financial stability or to the orderly functioning of financial markets in the Union, the resolution objectives laid down in Article 21 of Regulation (EU) 2021/23 and the criteria set out in Article 5(4) and (5) of this Regulation. 3. Where the suspension of the clearing obligation is considered by ESMA to be a material change in the criteria for the trading obligation to take effect referred to in Article 32(5) of Regulation (EU) No 600/2014, ESMA may request the Commission to suspend the trading obligation laid down in Article 28(1) and (2) of that Regulation for the same specific classes of OTC derivatives that are subject to the request to suspend the clearing obligation. ESMA shall submit its reasoned request to the authority referred to in the first subparagraph of paragraph 1 and the ESRB at the same time the request is submitted to the Commission. 4. The requests referred to in paragraphs 1 and 3 and the opinion referred to in paragraph 2 shall not be made public. 5. The Commission shall, without undue delay after receipt of the request referred to in paragraph 1, on the basis of the reasons and evidence provided by the authority referred to in paragraph 1, either suspend the clearing obligation for the specific classes of OTC derivatives by way of an implementing act, or reject the requested suspension. In adopting the implementing act referred to in the first subparagraph, the Commission shall take into account the opinion issued by ESMA referred to in paragraph 2 of this Article, the resolution objectives referred to in Article 21 of Regulation (EU) 2021/23, the criteria set out in Article 5(4) and (5) of this Regulation regarding those OTC derivative classes and the necessity of the suspension to avoid or address a serious threat to financial stability or the orderly functioning of financial markets in the Union. Where the Commission rejects the requested suspension, it shall provide reasons therefor in writing to the requesting authority referred to in the first subparagraph of paragraph 1 and to ESMA. The Commission shall immediately inform the European Parliament and the Council thereof and forward them the reasons provided to the requesting authority referred to in the first subparagraph of paragraph 1 and to ESMA. Such information shall not be made public. The implementing act referred to in the first subparagraph of this paragraph shall be adopted in accordance with the procedure referred to in Article 86(3). 6. Where requested by ESMA in accordance with paragraph 3 of this Article, the implementing act suspending the clearing obligation may also suspend the trading obligation laid down in Article 28(1) and (2) of Regulation (EU) No 600/2014 for the same specific classes of OTC derivatives that are subject to the suspension of the clearing obligation. 7. The suspension of the clearing obligation and, where applicable, of the trading obligation shall be communicated to the requesting authority referred to in the first subparagraph of paragraph 1 of this Article and to ESMA and shall be published in the Official Journal of the European Union, on the Commission’s website and in the public register referred to in Article 6. 8. The suspension of the clearing obligation pursuant to paragraph 5 shall be valid for an initial period of no more than three months from the date of application of that suspension. The suspension of the trading obligation referred to in paragraph 6 shall be valid for the same initial period. 9. Where the grounds for the suspension continue to apply, the Commission may, by way of an implementing act, extend the suspension referred to in paragraph 5 for additional periods of no more than three months, with the total period of the suspension of no more than 12 months. Any extensions of the suspension shall be published in accordance with paragraph 7. The implementing act referred to in the first subparagraph of this paragraph shall be adopted in accordance with the procedure referred to in Article 86(3). 10. Any of the authorities referred to in the first subparagraph of paragraph 1 may, in sufficient time before the end of the initial suspension period referred to in paragraph 5, or the extension period referred to in paragraph 9, issue a request to the Commission to extend the suspension of the clearing obligation. The request shall be accompanied by evidence that the conditions laid down in points (a) and (b) of the first subparagraph of paragraph 1 continue to be met. The authority referred to in the first subparagraph shall notify its reasoned request to ESMA and the ESRB at the same time that the request is notified to the Commission. The request referred to in the first subparagraph shall not be made public. ESMA shall without undue delay after the receipt of the notification of the request and, if it deems necessary, after consulting the ESRB, issue an opinion to the Commission on whether the grounds for the suspension continue to apply taking into account the necessity to avoid or address a serious threat to financial stability or the orderly functioning of financial markets in the Union, the resolution objectives laid down in Article 21 of Regulation (EU) 2021/23 and the criteria set out in Article 5(4) and (5) of this Regulation. ESMA shall send a copy of that opinion to the European Parliament and to the Council. That opinion shall not be made public. The implementing act extending the suspension of the clearing obligation may also extend the period of the suspension of the trading obligation referred to in paragraph 6. The extension of the suspension of the trading obligation shall be valid for the same period as the extension of the suspension of the clearing obligation. (*) Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (OJ L 022, 22.1.2021, p. 1).’;" (2) the following Article is inserted: ‘Article 13a Replacement of interest rate benchmarks in legacy trades 1. Counterparties referred to in Article 11(3) may continue to apply the risk-management procedures that they have in place at the date of application of this Regulation in respect of non-centrally cleared OTC derivative contracts entered into or novated before the date on which the obligation to have risk-management procedures pursuant to Article 11(3) takes effect where, after 11 February 2021, those contracts are novated for the sole purpose of replacing the interest rate benchmark they are referring to or of introducing fallback provisions in relation to that benchmark. 2. Transactions entered into or novated before the date on which the clearing obligation takes effect pursuant to Article 4 and which, after 11 February 2021, are subsequently novated for the sole purpose of replacing the interest rate benchmark they are referring to or of introducing fallback provisions in relation to that benchmark, shall not, for that reason, become subject to the clearing obligation referred to in Article 4.’; (3) in Article 24a(7), point (b) is replaced by the following: ‘(b) at least annually, initiate and coordinate Union-wide assessments of the resilience of CCPs to adverse market developments in accordance with Article 32(2) of Regulation (EU) No 1095/2010, taking into account, where possible, the aggregate effect of CCP recovery and resolution arrangements on Union financial stability;’; (4) in Article 28, paragraph 3 is replaced by the following: ‘3. The risk committee shall advise the board on any arrangements that may impact the risk management of the CCP, such as a significant change in its risk model, the default procedures, the criteria for accepting clearing members, the clearing of new classes of instruments, or the outsourcing of functions. The risk committee shall inform the board in a timely manner of any new risk affecting the resilience of the CCP. The advice of the risk committee is not required for the daily operations of the CCP. Reasonable efforts shall be made to consult the risk committee on developments impacting the risk management of the CCP in emergency situations, including on developments relevant to clearing members’ exposures to the CCP and interdependencies with other CCPs.’; (5) in Article 28, paragraph 5 is replaced by the following: ‘5. A CCP shall promptly inform the competent authority and the risk committee of any decision in which the board decides not to follow the advice of the risk committee and explain such decision. The risk committee or any member of the risk committee may inform the competent authority of any areas in which it considers that the advice of the risk committee has not been followed.’; (6) in Article 37(2), the following subparagraph is added: ‘The CCP shall inform the competent authority of any significant negative development regarding the risk profile of any of its clearing members determined in the context of the CCP’s assessment referred to in the first subparagraph or any other assessment with similar conclusion, including any increase in the risk that any of its clearing members brings to the CCP, which the CCP considers to have the potential of triggering a default procedure.’; (7) in Article 38, the following paragraph is added: ‘8. The clearing members of the CCP shall clearly inform their existing and potential clients of the potential losses or other costs that they may bear as a result of the application of default management procedures and loss and position allocation arrangements under the CCP’s operating rules, including the type of compensation they may receive, taking into account Article 48(7). Clients shall be provided with sufficiently detailed information to ensure that they understand the worst-case losses or other costs they could face should the CCP undertake recovery measures.’; (8) the following Article is inserted: ‘Article 45a Temporary restrictions in the case of a significant non-default event 1. In the case of a significant non-default event as defined in point (9) of Article 2 of Regulation (EU) 2021/23, the competent authority may require the CCP to refrain from any of the following actions for a period specified by the competent authority, that cannot exceed five years: (a) making a dividend distribution or give an irrevocable commitment to make a dividend distribution, except for rights to dividends specifically referred to in Regulation (EU) 2021/23 as a form of compensation; (b) buy-back of ordinary shares; (c) creating an obligation to pay variable remuneration as defined by the CCP’s remuneration policy pursuant to Article 26(5) of this Regulation, discretionary pension benefits or severance packages to senior management as defined in point 29 of Article 2 of this Regulation. The competent authority shall not restrict the CCP from undertaking any of the actions referred to in the first subparagraph, if the CCP is legally obliged to undertake that action and the obligation predates the events pursuant to the first subparagraph. 2. The competent authority may decide to waive the restrictions in paragraph 1 where it deems that waiving those restrictions would not reduce the quantity or availability of the CCP’s own resources, in particular own resources available for use as a recovery measure. 3. ESMA shall by 12 February 2022 draft guidelines in accordance with Article 16 of Regulation (EU) No 1095/2010 further specifying the circumstances in which the competent authority may require the CCP to refrain from undertaking any of the actions referred to in paragraph 1 of this Article.’; (9) in Article 81(3), first subparagraph, the following point is added: ‘(r) the resolution authorities designated under Article 3 of Regulation (EU) 2021/23.’. Article 88 Amendment to Regulation (EU) 2015/2365 In Article 12(2), the following point is added: ‘(n) the resolution authorities designated under Article 3 of Regulation (EU) 2021/23 of the European Parliament and of the Council (*). Article 89 Amendments to Directive 2002/47/EC Directive 2002/47/EC is amended as follows: (1) in Article 1, paragraph 6 is replaced by the following: ‘6. Articles 4 to 7 of this Directive shall not apply to any restriction on the enforcement of financial collateral arrangements or any restriction on the effect of a security financial collateral arrangement, any close out netting or set-off provision that is imposed by virtue of Title IV, Chapter V or VI of Directive 2014/59/EU of the European Parliament and of the Council (*), or of Title V, Chapter III, Section 3, or Chapter IV of Regulation (EU) 2021/23 of the European Parliament and of the Council (**) or to any such restriction that is imposed by virtue of similar powers in the law of a Member State to facilitate the orderly resolution of any entity referred to in point (c)(iv) or (d) of paragraph 2 of this Article which is subject to safeguards at least equivalent to those set out in Title IV, Chapter VII of Directive 2014/59/EU or in Title V, Chapter V of Regulation (EU) 2021/23. (*) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190)." (**) Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (OJ L 022, 22.1.2021, p. 1).’;" (2) Article 9a is replaced by the following: ‘Article 9a Directive 2008/48/EC, Directive 2014/59/EU and Regulation (EU) 2021/23 This Directive shall be without prejudice to Directive 2008/48/EC, Directive 2014/59/EU and Regulation (EU) 2021/23.’. Article 90 Amendment to Directive 2004/25/EC In Article 4(5), the third subparagraph is replaced by the following: ‘Member States shall ensure that Article 5(1) of this Directive does not apply in the case of application of resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU of the European Parliament and of the Council (*) or in Title V of Regulation (EU) 2021/23 of the European Parliament and of the Council (**). Article 91 Amendments to Directive 2007/36/EC Directive 2007/36/EC is amended as follows: (1) in Article 1, paragraph 4 is replaced by the following: ‘4. Member States shall ensure that this Directive does not apply in the case of the application of resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU of the European Parliament and of the Council (*) or in Title V of Regulation (EU) 2021/23 of the European Parliament and of the Council (**). (*) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190)." (**) Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (OJ L 022, 22.1.2021, p. 1).’;" (2) in Article 5, paragraph 5 is replaced by the following: ‘5. Member States shall ensure that for the purposes of Directive 2014/59/EU and Regulation (EU) 2021/23 the general meeting may, by a majority of two-thirds of the votes validly cast, issue a convocation to a general meeting, or modify the statutes to prescribe that a convocation to a general meeting is issued, at shorter notice than as laid down in paragraph 1 of this Article, to decide on a capital increase, provided that that meeting does not take place within ten calendar days of the convocation, that the conditions of Article 27 or 29 of Directive 2014/59/EU or of Article 18 of Regulation (EU) 2021/23 are met, and that the capital increase is necessary to avoid the conditions for resolution laid down in Articles 32 and 33 of Directive 2014/59/EU or in Article 22 of Regulation (EU) 2021/23.’. Article 92 Amendment to Directive (EU) 2017/1132 Directive (EU) 2017/1132 is amended as follows: (1) in Article 84, paragraph 3 is replaced by the following: ‘3. Member States shall ensure that Article 49, Article 58(1), Article 68(1), (2) and (3), the first subparagraph of Article 70(2), Articles 72 to 75, 79, 80 and 81 of this Directive do not apply in the case of application of the resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU of the European Parliament and of the Council (*) or in Title V of Regulation (EU) 2021/23 of the European Parliament and of the Council (**). (*) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190)." (**) Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (OJ L 022, 22.1.2021, p. 1).’;" (2) Article 86a is amended as follows: (a) point (b) of paragraph 3 is replaced by the following: ‘(b) the company is subject to resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU or in Title V of Regulation (EU) 2021/23.’; (b) point (c) of paragraph 4 is replaced by the following: ‘(c) the subject of crisis prevention measures as defined in point (101) of Article 2(1) of Directive 2014/59/EU or in point (48) of Article 2 of Regulation (EU) 2021/23.’; (3) in Article 87, paragraph 4 is replaced by the following: ‘4. Member States shall ensure that this Chapter does not apply to companies which are the subject of the application of resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU or in Title V of Regulation (EU) 2021/23.’; (4) Article 120 is amended as follows: (a) point (b) of paragraph 4 is replaced by the following: ‘(b) the company is subject to resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU or in Title V of Regulation (EU) 2021/23.’; (b) point (c) of paragraph 5 is replaced by the following: ‘(c) the subject of crisis prevention measures as defined in point (101) of Article 2(1) of Directive 2014/59/EU or in point (48) of Article 2 of Regulation (EU) 2021/23.’; (5) Article 160a is amended as follows: (a) point (b) of paragraph 4 is replaced by the following: ‘(b) the company is subject to resolution tools, powers and mechanisms provided for in Title IV of Directive 2014/59/EU or in Title V of Regulation (EU) 2021/23.’; (b) point (c) of paragraph 5 is replaced by the following: ‘(c) the subject of crisis prevention measures as defined in point (101) of Article 2(1) of Directive 2014/59/EU or in point (48) of Article 2 of Regulation (EU) 2021/23.’. Article 93 Amendment to Directive 2014/59/EU In Article 1, the following paragraph is added: ‘3. This Directive shall not apply to entities that are also authorised in accordance with Article 14 of Regulation (EU) No 648/2012.’. Article 94 Amendment to Regulation (EU) No 806/2014 Article 2 is amended as follows: (a) the first subparagraph is numbered as paragraph 1; (b) the following paragraph is added: ‘2. This Regulation shall not apply to entities that are also authorised in accordance with Article 14 of Regulation (EU) No 648/2012.’. Article 95 Amendment to Regulation (EU) No 600/2014 In Article 54(2), the first subparagraph is replaced by the following: ‘If the Commission assesses that there is no need to exclude exchange-traded derivatives from the scope of Articles 35 and 36 in accordance with Article 52(12), a CCP or a trading venue may, before 11 February 2021, apply to its competent authority for permission to avail itself of transitional arrangements. The competent authority, taking into account the risks resulting from the application of the access rights under Article 35 or 36 as regards exchange-traded derivatives to the orderly functioning of the relevant CCP or trading venue, may decide that Article 35 or 36 would not apply to the relevant CCP or trading venue, respectively, in respect of exchange-traded derivatives, for a transitional period until 3 July 2021. Where such a transitional period is approved, the CCP or trading venue shall not benefit from the access rights under Article 35 or 36, as regards exchange-traded derivatives for the duration of that period. The competent authority shall notify ESMA and, in the case of a CCP, the college of competent authorities for that CCP, when a transitional period is approved.’. TITLE IX FINAL PROVISIONS Article 96 Review By 12 February 2024, ESMA shall assess the staffing and resources needs arising from the assumption of its powers and duties in accordance with this Regulation and submit a report to the European Parliament, to the Council and to the Commission. By 12 February 2026, the Commission shall review the implementation of this Regulation and shall submit a report thereon to the European Parliament and to the Council. It shall assess at least the following: (a) the appropriateness and sufficiency of financial resources available to the resolution authority to cover losses arising from a non-default event; (b) the amount of own resources of the CCP to be used in recovery and in resolution and the means for its use; and (c) whether the resolution tools available to the resolution authority are adequate. Where appropriate, that report shall be accompanied by proposals for revision of this Regulation. By 31 December 2021, the Commission shall review the application of Article 27(7). The Commission shall assess in particular the need for any further amendments with regard to the application of the write-down and conversion tool in the event of resolution of CCPs in combination with other resolution tools that result in financial losses being borne by clearing members. The Commission shall submit a report thereon to the European Parliament and to the Council accompanied where appropriate by proposals for revision of this Regulation. By 12 August 2027, the Commission shall review this Regulation and its implementation and shall assess the effectiveness of the governance arrangements for the recovery and resolution of CCPs in the Union and submit a report thereon to the European Parliament and to the Council, accompanied where appropriate by proposals for revision of this Regulation. Article 97 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 12 August 2022 with the exception of: Article 95 which shall apply from 4 July 2020; Article 87(2) which shall apply from 11 February 2021; Articles 9(1), 9(2), 9(3), 9(4), 9(6), 9(7), 9(9), 9(10), 9(12), 9(13), 9(16), 9(17), 9(18), 9(19), 10(1), 10(2), 10(3), 10(8), 10(9), 10(10), 10(11), 10(12) and 11 which shall apply from 12 February 2022; Articles 9(14) and 20 which shall apply from 12 February 2023. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 16 December 2020. For the European Parliament President D. M. SASSOLI For the Council President M. ROTH (1) OJ C 209, 30.6.2017, p. 28. (2) OJ C 372, 1.11.2017, p. 6. (3) Position of the European Parliament of 27 March 2019 (not yet published in the Official Journal) and Position of the Council at first reading of 17 November 2020 (not yet published in the Official Journal). Position of the European Parliament of 14 December 2020 (not yet published in the Official Journal). (4) Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (OJ L 201, 27.7.2012, p. 1). (5) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190). (6) Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84). (7) Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12). (8) Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC (OJ L 173, 12.6.2014, p. 1). (9) Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems (OJ L 166, 11.6.1998, p. 45). (10) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338). (11) Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84). (12) Regulation (EU) 2015/2365 of the European Parliament and of the Council of 25 November 2015 on transparency of securities financing transactions and of reuse and amending Regulation (EU) No 648/2012 (OJ L 337, 23.12.2015, p. 1). (13) Directive 2002/47/EC of the European Parliament and of the Council of 6 June 2002 on financial collateral arrangements (OJ L 168, 27.6.2002, p. 43). (14) Directive (EU) 2017/1132 of the European Parliament and of the Council of 14 June 2017 relating to certain aspects of company law (OJ L 169, 30.6.2017, p. 46). (15) Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids (OJ L 142, 30.4.2004, p. 12). (16) Directive 2007/36/EC of the European Parliament and of the Council of 11 July 2007 on the exercise of certain rights of shareholders in listed companies (OJ L 184, 14.7.2007, p. 17). (17) Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (OJ L 225, 30.7.2014, p. 1). (18) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). (19) Regulation (EU) 2015/2365 of the European Parliament and of the Council of 25 November 2015 on transparency of securities financing transactions and of reuse and amending Regulation (EU) No 648/2012 (OJ L 337, 23.12.2015, p. 1). (20) Directive 2002/47/EC of the European Parliament and of the Council of 6 June 2002 on financial collateral arrangements (OJ L 168, 27.6.2002, p. 43). (21) Directive (EU) 2019/2162 of the European Parliament and of the Council of 27 November 2019 on the issue of covered bonds and covered bond public supervision and amending Directives 2009/65/EC and 2014/59/EU (OJ L 328, 18.12.2019, p. 29). (22) Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring special tasks on the European Central Bank concerning policies to the prudential supervision of credit institutions (OJ L 287, 29.10.2013, p. 63). (23) Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Insurance and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC (OJ L 331, 15.12.2010, p. 48). (24) Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (OJ L 168, 30.6.2017, p. 12). (25) Directive 2001/34/EC of the European Parliament and of the Council of 28 May 2001 on the admission of securities to official stock exchange listing and on information to be published on those securities (OJ L 184, 6.7.2001, p. 1). (26) Directive 2004/109/EC of the European Parliament and of the Council of 15 December 2004 on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC (OJ L 390, 31.12.2004, p. 38). ANNEX SECTION A Requirements for recovery plans The recovery plan shall include the following items: (1) a summary of the key elements of the plan and a summary of overall recovery capacity; (2) a summary of the material changes to the CCP since the most recently filed recovery plan; (3) a communication and disclosure plan outlining how the CCP intends to keep its competent authority informed of the recovery situation and manage any potentially negative market reactions while acting in as transparent a manner as possible; (4) a comprehensive range of capital, loss allocation, position allocation and liquidity actions required to maintain or restore the viability and financial soundness of the CCP including to restore its matched book and capital, and replenish pre-funded resources and maintain access to sufficient sources of liquidity which are necessary for the CCP to maintain its viability as a going concern and to continue providing its critical services in accordance with the delegated acts adopted on the basis of Articles 16(3) and 44(2) of Regulation (EU) No 648/2012. Loss allocation actions may include recovery cash calls and a reduction in the value of gains payable by the CCP to non-defaulting clearing members, where defined in the operating rules of the CCP, and shall not use the initial margins posted by non-defaulting clearing members to allocate losses in accordance with Article 45(4) of Regulation (EU) No 648/2012; (5) an assessment of the recovery options with respect to: (i) the impact of their implementation on the solvency, liquidity, funding positions, profitability and operations of the CCP; (ii) the external impact and systemic consequences of their implementation on critical functions, shareholders, clearing members, creditors and other stakeholders of the CCP, and where applicable, the rest of the group, and to the extent the information is available, clients and indirect clients of the CCP; (iii) the feasibility of their implementation, following a detailed analysis of risks, impediments and solutions for the impediments; and (iv) the impact of their implementation on the continuity of operations, in particular human resources and IT, and access to other financial infrastructures. (6) appropriate conditions and procedures to ensure the timely implementation of recovery actions, including an estimation of the timeframe for implementing each material aspect of the plan; (7) a detailed description of any material impediment to the effective and timely implementation of the plan, including consideration of the impact on clearing members and clients including in cases where clearing members are likely to take measures in accordance with their recovery plans as referred to in Articles 5 and 7 of Directive 2014/59/EU, and where appropriate on the rest of the group; (8) an assessment of the appropriateness of the recovery options to address each relevant recovery plan scenario, based on how those options: (i) ensure transparency and allow those who could be exposed to losses and liquidity shortfalls to measure, manage and control such potential losses and shortfalls; (ii) provide incentives to shareholders, clearing members and their clients and the financial system; and (iii) minimise negative impact on clearing members and their clients and the financial system; (9) identification of critical functions; (10) a detailed description of the processes for determining the value and marketability of the core business lines, operations and assets of the CCP; (11) a detailed description of how recovery planning is integrated into the corporate governance structure of the CCP, how it forms part of the operating rules of the CCP agreed to by clearing members, as well as the policies and procedures governing the approval of the recovery plan and identification of the persons in the organisation responsible for drawing up and implementing the plan; (12) arrangements and measures incentivising non-defaulting clearing members to bid competitively in auctions of a defaulted members’ positions; (13) arrangements and measures to ensure that the CCP has adequate access to contingency funding sources, including potential liquidity sources, to enable it to continue to carry out its operations and meet its obligations as they fall due; (14) an assessment of available collateral and an assessment of the possibility to transfer resources or liquidity across business lines; (15) arrangements and measures: (i) to reduce risk; (ii) to restructure contracts, rights, assets and liabilities; (iii) to restructure business lines; (iv) necessary to maintain continuous access to FMIs and trading venues; (v) necessary to maintain the continuous functioning of the CCP’s operational processes, including infrastructure and IT services; (vi) to partially or fully terminate contracts; (vii) to reduce the value of any gains payable by the CCP to non-defaulting clearing members, if applicable, depending on the type of instruments that the CCP clears; and (viii) to oblige non-defaulting clearing members to make a contribution in cash to the CCP up to at least each clearing member’s contribution to the default fund. This recovery cash call obligation shall also be included and referred to in the CCP’s rules and other contractual arrangements; (16) preparatory arrangements to facilitate the sale of assets or business lines in a timeframe appropriate for the restoration of financial soundness, including an assessment of the potential impact of such a sale on the operations of the CCP; (17) where other management actions or strategies to restore financial soundness are envisaged, a description of those actions or strategies and their anticipated financial effect; (18) preparatory measures that the CCP has taken or plans to take in order to facilitate the implementation of the recovery plan, including those necessary to enable the timely recapitalisation of the CCP, restoring its matched book and replenishment of its pre-funded resources as well as its enforceability across borders; (19) a framework of quantitative and qualitative indicators which identifies the points at which appropriate actions referred to in the plan may be taken; (20) where applicable, an analysis of how and when the CCP may apply, in the conditions addressed in the plan, for the use of central bank facilities and identify those assets that would be expected to qualify as collateral under the terms of the central bank facility; (21) taking into account Article 49(1) of Regulation (EU) No 648/2012, a range of scenarios that would severely affect the financial soundness or operational viability of the CCP and be relevant to the CCP’s specific conditions such as its product mix, business model and liquidity and risk governance framework, including scenarios involving system-wide events or events specific to the legal entity and any group to which it belongs and specific stress to the individual clearing members of the CCP or, where appropriate, a linked FMI; and (22) taking into account Article 34, and Article 49(1), of Regulation (EU) No 648/2012, a range of scenarios that would severely affect the financial soundness or operational viability of the CCP and result both from the stress or default of one or more of its members, including scenarios going beyond the stress or default of at least the two clearing members to which the CCP has the largest exposures under extreme but plausible market conditions, and from other reasons including losses from the CCP’s investment activities or from operational problems, including severe external threats to a CCP’s operations due to an external disruption, shock or cyber-related incident. SECTION B Information that resolution authorities may request CCPs to provide for the purposes of drawing up and maintaining resolution plans For the purposes of drawing up and maintaining resolution plans, resolution authorities may request CCPs to provide at least the following information: (1) a detailed description of the CCP’s organisational structure including a list of all legal persons; (2) identification of the direct holders and the percentage of voting and non-voting rights of each legal person; (3) the location, jurisdiction of incorporation, licensing and key management associated with each legal person; (4) a mapping of the CCP’s critical functions and core business lines, including balance sheet details of such functions and business lines, by reference to legal persons; (5) a detailed description of the components of the CCP’s and all its legal entities’ business activities, separating, at a minimum by types of services and respective amounts of cleared volumes, open interest, initial margin, variation margin flows, default funds and any associated assessment rights or other recovery actions pertaining to such business lines; (6) details of capital and debt instruments issued by the CCP and its legal entities; (7) an identification of from whom the CCP has received collateral and in what form (title transfer or security interest), and to whom it has pledged collateral and in what form and the person that holds the collateral, and in both cases the jurisdiction in which the collateral is located; (8) a description of the off balance sheet exposures of the CCP and its legal entities, including a mapping to its critical operations and core business lines; (9) the material hedges of the CCP including a mapping to legal persons; (10) identification of the relative exposures and importance of clearing members of the CCP as well as an analysis of the impact of the failure of major clearing members on the CCP; (11) each system on which the CCP conducts a material number or value amount of trades, including a mapping to the CCP’s legal persons, critical operations and core business lines; (12) each payment, clearing or settlement system of which the CCP is directly or indirectly a member, including a mapping to the CCP’s legal persons, critical operations and core business lines; (13) a detailed inventory and description of the key management information systems, including those for risk management, accounting and financial and regulatory reporting used by the CCP including a mapping to the CCP’s legal persons, critical operations and core business lines; (14) an identification of the owners of the systems identified in point (13), service level agreements related thereto, and any software and systems or licenses, including a mapping to their legal entities, critical operations and core business lines; (15) an identification and mapping of the legal persons and the interconnections and interdependencies among the different legal persons such as: (i) common or shared personnel, facilities and systems; (ii) capital, funding or liquidity arrangements; (iii) existing or contingent credit exposures; (iv) cross-guarantee agreements, cross-collateral arrangements, cross-default provisions and cross-affiliate netting arrangements; (v) risks transfers and back-to-back trading arrangements; (vi) service level agreements; (16) the competent authority and resolution authority for each legal person, if different to those designated under Article 22 of Regulation (EU) No 648/2012 and under Article 3 of this Regulation; (17) the member of the board responsible for providing the information necessary to draw up the resolution plan of the CCP as well as those responsible, if different, for the different legal persons, critical operations and core business lines; (18) a description of the arrangements that the CCP has in place to ensure that, in the event of resolution, the resolution authority will have all the necessary information, as determined by the resolution authority, for applying the resolution tools and exercising the resolution powers; (19) all the agreements entered into by the CCP and their legal entities with third parties the termination of which may be triggered by a decision of the authorities to apply a resolution tool and whether the consequences of termination may affect the application of the resolution tool; (20) a description of possible liquidity sources for supporting resolution; (21) information on asset encumbrance, liquid assets, off-balance sheet activities, hedging strategies and booking practices. SECTION C Matters that the resolution authority is to consider when assessing the resolvability of a CCP When assessing the resolvability of a CCP, the resolution authority shall consider the following: (1) the extent to which the CCP is able to map core business lines and critical operations to legal persons; (2) the extent to which legal and corporate structures are aligned with core business lines and critical operations; (3) the extent to which the legal structure of the CCP inhibits the application of the resolution tools as a result of the number of legal persons, the complexity of the group structure or the difficulty in aligning business lines to group entities; (4) the extent to which there are arrangements in place to provide for essential staff, infrastructure, funding, liquidity and capital to support and maintain the core business lines and the critical operations; (5) the existence and robustness of service level agreements; (6) the extent to which the service agreements that the CCP maintains are fully enforceable in the event of resolution of the CCP; (7) the extent to which the governance structure of the CCP is adequate for managing and ensuring compliance with the CCP’s internal policies with respect to its service level agreements; (8) the extent to which the CCP has a process for transitioning the services provided under service level agreements to third parties in the event of the separation of critical functions or of core business lines; (9) the extent to which there are contingency plans and measures in place to ensure continuity in access to payment and settlement systems; (10) the adequacy of the management information systems in ensuring that the resolution authorities are able to gather accurate and complete information regarding the core business lines and critical operations so as to facilitate rapid decision making; (11) the capacity of the management information systems to provide the information essential for the effective resolution of the CCP at all times even under rapidly changing conditions; (12) the extent to which the CCP has tested its management information systems under stress scenarios as defined by the resolution authority; (13) the extent to which the CCP can ensure the continuity of its management information systems both for the affected CCP and the new CCP in the case that the critical operations and core business lines are separated from the rest of the operations and business lines; (14) the extent to which any intra-group guarantees are provided at market conditions and the risk management systems concerning those guarantees are robust, where the CCP benefits from or is exposed to such guarantees; (15) the extent to which any intra-group transactions are performed at market conditions and the risk management systems concerning those transactions practices are robust, where the CCP engages in such transactions; (16) the extent to which the use of any intra-group guarantees or transactions increases contagion across the group; (17) the extent to which the resolution of the CCP could have a negative impact on another part of its group, in particular where such group comprises other FMIs, where applicable; (18) whether third-country authorities have the resolution tools necessary to support resolution actions by Union resolution authorities, and the scope for coordinated action between Union and third-country authorities; (19) the feasibility of applying resolution tools in such a way which meets the resolution objectives, given the tools available and the CCP’s structure; (20) any specific requirements needed to issue new instruments of ownership as referred to in Article 33(1); (21) the arrangements and means through which resolution could be hampered in the cases of CCP that have clearing members or collateral arrangements established in different jurisdictions; (22) the credibility of applying resolution tools in such a way which meets the resolution objectives, given possible impacts on clearing members and, where applicable, their clients, other counterparties and employees and possible actions that third-country authorities may take; (23) the extent to which the impact of the CCP’s resolution on the financial system and on financial market’s confidence can be adequately evaluated; (24) the extent to which the resolution of the CCP could have a significant direct or indirect adverse effect on the financial system, market confidence or the economy; (25) the extent to which contagion to other CCPs or to the financial markets could be contained through the application of the resolution tools and the exercise of the resolution powers; and (26) the extent to which the resolution of the CCP could have a significant effect on the operation of payment and settlement systems.

Recovery and resolution of central counterparties Recovery and resolution of central counterparties SUMMARY OF: Regulation (EU) 2021/23 on a framework for the recovery and resolution of central counterparties WHAT IS THE AIM OF THE REGULATION? It lays down rules and procedures for the recovery and resolution of central counterparties (CCPs)*. These are designed to ensure CCPs have measures to recover from financial distress or can continue their main tasks if they are failing, or likely to fail, while winding up other activities through normal insolvency procedures. The overall aim is to preserve financial stability and minimise the costs to taxpayers of any CCP failure. KEY POINTS Each European Union (EU) Member State has the following responsibilities. Appointing one or more resolution authorities. These:may be national central banks, ministries or public authorities with administrative powers;have the expertise, resources, operational capacity and extensive powers to act quickly and flexibly. Designating a single ministry with overall responsibility for exercising the functions entrusted to the ministries under the legislation. Applying penalties for breaches of the regulation. Resolution authorities establish, manage and chair a resolution college. This includes the relevant authorities and provides a framework to: share information; draw up resolution plans; assess a CCP’s resolvability and possible obstacles; coordinate public information about resolution plans and strategies. The European Securities and Markets Authority (ESMA): drafts various regulatory technical standards that will be adopted by the European Commission; creates the ESMA Resolution Committee that will promote the drawing up and coordination of resolution plans and develop methods for the resolution of failing CCPs; cooperates with the European Insurance and Occupational Pensions Authority and the European Banking Authority; maintains a central database of national penalties applied for breaches of the legislation. Competent authorities, resolution authorities and ESMA: cooperate closely to carry out the tasks set out in the regulation; base decisions on principles such as: proportionality in view of the CCP’s legal form, size, complexity and liquidity,the need for efficacy and timeliness, the need to keep down costs and, as far as possible, avoid use of public finance. Recovery planning requires CCPs to draw up and maintain a recovery plan. These: set out actions, with or without a default, to restore financial soundness; include measures to address all possible risks, absorb losses and replenish financial resources; contain indicators based on a CCP’s risk profile; do not assume access to public finance or central bank liquidity; consider the interests of all stakeholders; ensure clearing members do not have unlimited exposure to the CCP. It also requires the competent authority, supervisory college and resolution authority to assess the recovery plans and consider any changes. Resolution planning requires the following. The resolution authority of the CCP has to draw up a resolution plan that: sets out how it would use its resolution powers to absorb losses and ensure the continuity of the CCP’s critical functions;takes account of the impact of the plan on clearing members, financial markets and the financial system;does not assume access to public finance or central bank help;makes prudent assumptions about finance that might be available. CCPs under resolution have to cooperate with the resolution authority and provide all the necessary information; The resolution college has to agree on the plan, including any changes, within 4 months of receiving it. Assessing resolvability requires the resolution authority, coordinating with the resolution college, to: assess whether a CCP is resolvable, to enable it to continue operating its critical functions; identify any obstacles to resolvability and instruct the CCP to take action to remove them. Early intervention measures enable a competent authority to instruct a CCP it considers could be facing financial problems to: take corrective action; remove some or all of senior management or board members. Resolution authorities take special account of the following when implementing their plans. Objectives: continuity of the CCP’s critical functions; avoidance of damage to the financial system; protection of public funds. Conditions: CCP actual or likely failure; absence of alternative private sector solution; importance of protecting the public interest. Valuation: two assessments to ensure a fair, prudent and realistic appreciation of the CCP’s assets, liabilities, rights and obligations. Safeguards: shareholders, clearing members and other creditors should not lose more than if the resolution authority had not intervened (‘No creditor worse off’ principle); clients and indirect clients have the right to compensation clearing members may receive; anyone affected by a crisis prevention order or resolution action has a right of appeal. Resolution authorities can apply the following measures, individually or collectively. Position and loss allocation. Terminating contracts, reducing a CCP’s payment obligations to non-defaulting clearing members or requiring the latter to make a cash contribution to the CCP. Write-down and conversion. Reducing or converting the size of instruments of ownership, debt or other unsecured liabilities, requiring a CCP to provide and implement a business reorganisation plan. Sale of business. Selling ownership or any assets, rights, obligations or liabilities of a CCP in the resolution procedure. Bridge CCP. Transferring temporarily to another CCP (‘bridge CCP’) ownership or any assets, rights, obligations or liabilities of a CCP in the resolution procedure. Alternative funding. Contracting to borrow or obtain other forms of financing to address temporary cash flow problems. Member States may, if a CCP failure threatens a systemic crisis, inject cash or take it into public ownership (government stabilisation tools), provided the measures are temporary and comply with EU State aid rules. The regulation amends the following: Regulations (EU) No 1095/2010 (see summary), (EU) No 648/2012 (see summary), (EU) No 600/2014 (see summary), (EU) No 806/2014 (see summary) and (EU) 2015/2365 (see summary); Directives 2002/47/EC (see summary), 2004/25/EC (see summary), 2007/36/EC (see summary), 2014/59/EU (see summary) and (EU) 2017/1132 (see summary). Under the review procedure: ESMA assesses its staffing and resources needs by 12 February 2024; the Commission submits a report on the legislation to the European Parliament and the Council of the European Union by 12 February 2026. FROM WHEN DOES THE REGULATION APPLY? It entered into force on 11 February 2021 and applies from 12 August 2022 with the exception of a few articles that apply earlier. BACKGROUND Central counterparties are an essential part of the financial system as they manage a significant amount of counterparty risk and act as a link between multiple banks, other financial counterparties and corporations. The adoption of the European market infrastructure regulation, Regulation (EU) No 648/2012, ensured CCPs helped increase market transparency following the 2008 financial crisis. For further information, see: Recovery and resolution of central counterparties (CCPs) (European Commission). KEY TERMS Central counterparty. An entity that interposes itself between the counterparties to the contracts traded on one or more financial markets, becoming the buyer to every seller and the seller to every buyer. MAIN DOCUMENT Regulation (EU) 2021/23 of the European Parliament and of the Council of 16 December 2020 on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, (EU) No 600/2014, (EU) No 806/2014 and (EU) 2015/2365 and Directives 2002/47/EC, 2004/25/EC, 2007/36/EC, 2014/59/EU and (EU) 2017/1132 (OJ L 22, 22.1.2021, pp. 1–102). RELATED DOCUMENTS Directive (EU) 2017/1132 of the European Parliament and of the Council of 14 June 2017 relating to certain aspects of company law (OJ L 169, 30.6.2017, pp. 46–127). Successive amendments to Directive (EU) 2017/1132 have been incorporated in the original text. This consolidated version is of documentary value only. Regulation (EU) 2015/2365 of the European Parliament and of the Council of 25 November 2015 on transparency of securities financing transactions and of reuse and amending Regulation (EU) No 648/2012 (OJ L 337, 23.12.2015, pp. 1–34). Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (OJ L 225, 30.7.2014, pp. 1–90). See consolidated version. Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, pp. 190–348). See consolidated version. Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, pp. 84–148). See consolidated version. Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (OJ L 201, 27.7.2012, pp. 1–59). See consolidated version. Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, pp. 84–119). See consolidated version. Directive 2007/36/EC of the European Parliament and of the Council of 11 July 2007 on the exercise of certain rights of shareholders in listed companies (OJ L 184, 14.7.2007, pp. 17–24). See consolidated version. Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids (OJ L 142, 30.4.2004, pp. 12–23). See consolidated version. Directive 2002/47/EC of the European Parliament and of the Council of 6 June 2002 on financial collateral arrangements (OJ L 168, 27.6.2002, pp. 43–50). See consolidated version. last update 09.02.2022

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10.10.2013 EN Official Journal of the European Union L 269/1 REGULATION (EU) No 952/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 October 2013 laying down the Union Customs Code (recast) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 33, 114 and 207 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) A number of amendments are to be made to Regulation (EC) No 450/2008 of the European Parliament and of the Council of 23 April 2008 laying down the Community Customs Code (Modernised Customs Code) (3). In the interests of clarity, that Regulation should be recast. (2) It is appropriate to ensure that Regulation (EC) No 450/2008 is consistent with the Treaty on the Functioning of the European Union (TFEU), in particular Articles 290 and 291 thereof. It is also appropriate that the Regulation take account of the evolution of Union law and that some of its provisions are adapted in order to facilitate their application. (3) In order to supplement or amend certain non-essential elements of this Regulation, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (4) In particular, when preparing and drawing up delegated acts, the Commission should ensure that Member States' experts and the business community are consulted in a transparent manner, and well in advance. (5) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in order: to specify the format and code of the common data requirements for the purpose of the exchange of information between the customs authorities and between economic operators and customs authorities and the storage of such information and the procedural rules on the exchange and storage of information which can be made by means other than electronic data-processing techniques; to adopt decisions allowing one or several Member States to use means for the exchange and storage of information other than electronic data-processing techniques; to specify the customs authority which is responsible for the registration of economic operators and of other persons; to specify the technical arrangements for developing, maintaining and employing electronic systems; to specify the procedural rules on the conferral and proving of the entitlement for a customs representative to provide services in a Member State other than the one where he or she is established; the procedural rules on the submission and acceptance of an application for a decision relating to the application of the customs legislation, and on the taking and the monitoring of such a decision; the procedural rules on the annulment, revocation and amendment of favourable decisions; the procedural rules on the use of a decision relating to binding information after it ceases to be valid or is revoked; the procedural rules on the notification to the customs authorities that the taking of such decisions is suspended and on the withdrawal of such suspension; to adopt decisions requesting Member States to revoke decisions relating to binding information; to adopt the modalities for the application of the criteria for the granting of the status of authorised economic operator; to adopt measures to ensure uniform application of customs controls, including the exchange of risk information and analysis, common risk criteria and standards, control measures and priority control areas; to determine the ports or airports where customs controls and formalities are to be carried out on cabin and hold baggage; to lay down the rules on currency conversion; to adopt measures on the uniform management of tariff quota and tariff ceilings and the management of the surveillance of the release for free circulation or export of goods; to adopt measures to determine the tariff classification of goods; to specify the procedural rules on the provision and the verification of the proof of non-preferential origin; the procedural rules on the facilitation of the establishment in the Union of the preferential origin of goods; to adopt measures to determine the origin of specific goods; the granting of a temporary derogation from the rules on preferential origin of goods benefiting from preferential measures adopted unilaterally by the Union; the determination of the origin of specific goods; to specify the procedural rules on the determination of the customs value of goods; to specify the procedural rules on the provision of a guarantee, the determination of its amount, its monitoring and release and the revocation and cancellation of an undertaking given by a guarantor; to specify the procedural rules regarding temporary prohibitions of the use of comprehensive guarantees; to adopt measures to ensure mutual assistance between the customs authorities in the event of the incurrence of a customs debt; to specify the procedural rules on repayment and remission of an amount of import or export duty and the information to be provided to the Commission; to adopt decisions on repayment or remission of an amount of import or export duty; to specify the procedural rules on the lodging, amendment and invalidation of an entry summary declaration; to specify the time-limit within which a risk analysis is to be carried out on the basis of the entry summary declaration; to specify the procedural rules on the notification of arrival of sea-going vessels and aircraft and on the conveyance of goods to the appropriate place; to specify the procedural rules on the presentation of goods to customs; the procedural rules on the lodging, amendment and invalidation of the temporary storage declaration and on the movement of goods in temporary storage; the procedural rules for the provision and verification of the proof of the customs status of Union goods; the procedural rules on the determination of competent customs offices and on the lodging of the customs declaration where other means than electronic data processing techniques are used; the procedural rules on the lodging of a standard customs declaration and on the making available of supporting documents; the procedural rules on the lodging of a simplified declaration and a supplementary declaration; the procedural rules on the lodging of a customs declaration prior to the presentation of goods to customs, the acceptance of the customs declaration and the amendment of the customs declaration after the release of the goods; to adopt measures for the determination of the tariff subheading of the goods which are subject to the highest rate of import or export duty where a consignment is made of goods falling under different tariff subheadings; to specify the procedural rules on centralised clearance and on the waiver from the obligation for goods to be presented in that context; the procedural rules on entry in the declarant's records; the procedural rules on the customs formalities and controls to be carried out by the holder of the authorisation in the context of self-assessment; to adopt measures on the verification of the customs declaration, the examination and sampling of goods and the results of the verification; the procedural rules on the disposal of goods; the procedural rules on the provision of information establishing that the conditions for relief from import duty for returned goods are fulfilled and on the provision of evidence that the conditions for relief from import duty for products of sea-fishing and other products taken from the sea are fulfilled; the procedural rules on the examination of the economic conditions in the context of special procedures; the procedural rules on the discharge of a special procedure; the procedural rules on the transfer of rights and obligations and the movement of goods in the context of special procedures; the procedural rules on the use of equivalent goods in the context of special procedures; the procedural rules for the application of the provisions of international transit instruments in the customs territory of the Union; the procedural rules on the placing of goods under the Union transit procedure and on the end of that procedure, on the operation of the simplifications of that procedure and on the customs supervision of goods passing through the territory of a country or territory outside the customs territory of the Union under the external Union transit procedure; the procedural rules on the placing of goods under the customs warehousing or free zone procedure; to lay down the time-limit within which risk analysis is to be carried out on the basis of the pre-departure declaration; to specify the procedural rules on the exit of goods; the procedural rules on the lodging, amendment and invalidation of the exit summary declaration; the procedural rules on the lodging, amendment and invalidation of the re-export notification; to adopt a work programme supporting the development of related electronic systems and governing the setting up of transitional periods; to adopt decisions authorising Member States to test simplifications in the application of the customs legislation, especially when those simplifications are information technology (IT) related. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (4). (6) Considering the cooperation which is needed between the Member States and the Commission to develop, maintain and employ the electronic systems required for the implementation of the Union Customs Code (the Code), the Commission should not adopt the work programme supporting that development and governing the setting up of transitional periods where no opinion is delivered by the committee examining the draft implementing act. (7) The advisory procedure should be used for the adoption of: decisions allowing one or several Member States to use means for the exchange and storage of information other than electronic data-processing techniques, given that those decisions do not affect all Member States; decisions requesting Member States to revoke decisions relating to binding information, given that those decisions affect only one Member State and aim at ensuring compliance with the customs legislation; decisions on repayment or remission of an amount of import or export duty given that those decisions directly affect the applicant for that repayment or remission. (8) In duly justified cases, where imperative grounds of urgency so require, the Commission should adopt immediately applicable implementing acts relating to: measures to ensure uniform application of customs controls, including the exchange of risk information and analysis, common risk criteria and standards, control measures and priority control areas; the determination of the tariff classification of goods; the determination of the origin of specific goods; measures temporarily prohibiting the use of comprehensive guarantees. (9) The Union is based upon a customs union. It is advisable, in the interests both of economic operators and of the customs authorities in the Union, to assemble current customs legislation in a code. Based on the concept of an internal market, that code should contain the general rules and procedures which ensure the implementation of the tariff and other common policy measures introduced at Union level in connection with trade in goods between the Union and countries or territories outside the customs territory of the Union, taking into account the requirements of those common policies. Customs legislation should be better aligned on the provisions relating to the collection of import charges without change to the scope of the tax provisions in force. (10) In order to ensure effective administrative simplification, the views of economic operators should be taken into account when the customs legislation is further modernised. (11) In accordance with the Commission Communication of 9 August 2004 entitled "Protecting the Communities' financial interests - Fight against fraud - Action Plan for 2004-2005", it is appropriate to adapt the legal framework for the protection of the financial interests of the Union. (12) Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (5) was based upon integration of the customs procedures applied separately in the respective Member States during the 1980s. That Regulation has been repeatedly and substantially amended since its introduction, in order to address specific problems such as the protection of good faith or the taking into account of security requirements. Further amendments to that Regulation were introduced by Regulation (EC) No 648/2005 of the European Parliament and of the Council of 13 April 2005 (6) - and subsequently included in Regulation (EC) No 450/2008 - as a consequence of the important legal changes which have occurred in recent years, at both Union and international level, such as the expiry of the Treaty establishing the European Coal and Steel Community and the entry into force of the 2003, 2005 and 2011 Acts of Accession, as well as the amendment to the International Convention on the simplification and harmonisation of customs procedures (the Revised Kyoto Convention), the Union's accession to which was approved by Council Decision 2003/231/EC of 17 March 2003 (7). (13) It is appropriate to introduce in the Code a legal framework for the application of certain provisions of the customs legislation to trade in Union goods between parts of the customs territory to which the provisions of Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (8) or Council Directive 2008/118/EC of 16 December 2008 concerning the general arrangements for excise duty (9) apply and parts of that territory where those provisions do not apply, or to trade between parts where those provisions do not apply. Considering the fact that the goods concerned are Union goods and considering the fiscal nature of the measures at stake in that intra-Union trade, it is justified to introduce, appropriate simplifications to the customs formalities to be applied to those goods. (14) In order to take into account the special fiscal regime of certain parts of the customs territory of the Union, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the customs formalities and controls to be applied to the trade in Union goods between those parts and the rest of the customs territory of the Union. (15) The facilitation of legitimate trade and the fight against fraud require simple, rapid and standard customs procedures and processes. It is therefore appropriate, in line with the Commission Communication of 24 July 2003 entitled "A simple and paperless environment for customs and trade", to simplify customs legislation, to allow the use of modern tools and technology and to promote further the uniform application of customs legislation and modernised approaches to customs control, thus helping to ensure the basis for efficient and simple clearance procedures. Customs procedures should be merged or aligned and the number of procedures reduced to those that are economically justified, with a view to increasing the competitiveness of business. (16) The completion of the internal market, the reduction of barriers to international trade and investment and the reinforced need to ensure security and safety at the external borders of the Union have transformed the role of customs authorities giving them a leading role within the supply chain and, in their monitoring and management of international trade, making them a catalyst to the competitiveness of countries and companies. The customs legislation should therefore reflect the new economic reality and the new role and mission of customs authorities. (17) The use of information and communication technologies, as laid down in Decision No 70/2008/EC of the European Parliament and of the Council of 15 January 2008 on a paperless environment for customs and trade (10), is a key element in ensuring trade facilitation and, at the same time, the effectiveness of customs controls, thus reducing costs for business and risk for society. It is therefore necessary to establish in the Code the legal framework within which that Decision can be implemented, in particular the legal principle that all customs and trade transactions are to be handled electronically and that information and communication systems for customs operations are to offer, in each Member State, the same facilities to economic operators. (18) In order to ensure a paperless environment for customs and trade, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of common data requirements for the purpose of the exchange and storage of information using electronic data processing techniques, cases where other means may be used for such exchange and storage and registration of persons. Means other than electronic data processing techniques could be used in particular on a transitional basis, where the necessary electronic systems are not yet operational, but not beyond 31 December 2020. Insofar as centralised clearance is concerned, those transitional measures would consist, until the necessary electronic systems are operational, in maintaining the procedure currently known as the 'single authorisation for simplified procedures'. (19) Use of information and communication technologies should be accompanied by harmonised and standardised application of customs controls by the Member States, to ensure an equivalent level of customs control throughout the Union so as not to give rise to anti-competitive behaviour at the various Union entry and exit points. (20) In the interests of facilitating business, while at the same time providing for the proper levels of control of goods brought into or taken out of the customs territory of the Union, it is desirable that the information provided by economic operators be shared, taking account of the relevant data-protection provisions, between customs authorities and with other agencies involved in that control. Those controls should be harmonised, so that the economic operator need give the information only once and that goods are controlled by those authorities at the same time and at the same place. (21) In the interests of facilitating business, all persons should continue to have the right to appoint a representative in their dealings with the customs authorities. However, it should no longer be possible for that right of representation to be reserved under a law laid down by one of the Member States. Furthermore, a customs representative who complies with the criteria for the granting of the status of authorised economic operator for customs simplifications should be entitled to provide his or her services in a Member State other than the Member State where he or she is established. As a general rule, a customs representative should be established in the customs territory of the Union. That obligation should be waived where the customs representative acts on behalf of persons who are not required to be established within the customs territory of the Union or in other justified cases. (22) All decisions relating to the application of the customs legislation, including to binding information, should be covered by the same rules. Any such decisions should be valid throughout the Union and should be capable of being annulled, amended except where otherwise stipulated, or revoked where they do not conform to the customs legislation or its interpretation. (23) The streamlining of customs procedures within an electronic environment requires the sharing of responsibilities between the customs authorities of different Member States. It is necessary to ensure an appropriate level of effective, dissuasive and proportionate penalties throughout the internal market. (24) Compliant and trustworthy economic operators should enjoy the status of 'authorised economic operator' subject to the granting of an authorisation for customs simplifications or an authorisation for security and safety, or both. Depending on the type of authorisation granted, authorised economic operators should be able to take maximum advantage of widespread use of customs simplifications or benefit from facilitations relating to security and safety. They should also be given more favourable treatment in respect of customs controls, such as fewer physical and document-based controls. (25) Compliant and trustworthy economic operators should benefit from international mutual recognition of the status of 'authorised economic operator'. (26) In order to secure a balance between, on the one hand, the need for customs authorities to ensure the correct application of the customs legislation and, on the other, the right of economic operators to be treated fairly, the customs authorities should be granted extensive powers of control and economic operators a right of appeal. (27) In accordance with the Charter of Fundamental Rights of the European Union, it is necessary, in addition to the right of appeal against any decision taken by the customs authorities, to provide for the right of every person to be heard before any decision is taken which would adversely affect him or her. However, restrictions to that right may be justified in particular where the nature or the level of the threat to the security and safety of the Union and its residents, to human, animal or plant health, to the environment or to consumers so requires. (28) In order to minimise the risk to the Union, its citizens and its trading partners, the harmonised application of customs controls by the Member States should be based upon a common risk management framework and an electronic system for its implementation. The establishment of a risk management framework common to all Member States should not prevent them from controlling goods by random checks. (29) In order to ensure a consistent and equal treatment of persons concerned by customs formalities and controls, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of determining other cases where the customs representative is not obliged to be established in the customs territory of the Union and rules relating to decisions taken by the customs authorities, including those relating to binding information, authorised economic operator and simplifications. (30) It is necessary to establish the factors on the basis of which import or export duty and other measures in respect of trade in goods are applied. It is also appropriate to lay down more detailed provisions for issuing proofs of origin in the Union, where the exigencies of trade so require. (31) In order to supplement the factors on the basis of which import or export duty and other measures are applied, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of rules on origin of goods. (32) It is desirable to group together all cases of incurrence of a customs debt on import, other than following the submission of a customs declaration for release for free circulation or temporary admission with partial relief, in order to avoid difficulties in determining the legal basis on which the customs debt was incurred. The same should apply in cases of incurrence of a customs debt on export. (33) It is appropriate to establish the place where the customs debt is incurred and where the import or export duty should be recovered. (34) The rules for special procedures should allow for the use of a single guarantee for all categories of special procedures and for that guarantee to be comprehensive, covering a number of transactions. (35) A comprehensive guarantee with a reduced amount, including for customs debts and other charges which have been incurred, or a comprehensive guarantee with a guarantee waiver, should be authorised under certain conditions. A comprehensive guarantee with a reduced amount for customs debts and other charges which have been incurred should be equivalent to the provision of a guarantee for the whole amount of import or export duty payable, in particular for the purposes of the release of the goods concerned and of the entry in the accounts. (36) In order to ensure better protection of the financial interests of the Union and of the Member States, a guarantee should cover non-declared or incorrectly declared goods included in a consignment or in a declaration for which it is provided. For the same reason, the undertaking of the guarantor should also cover amounts of import or export duty which fall to be paid following post-release controls. (37) In order to safeguard the financial interests of the Union and of the Member States and to curb fraudulent practices, arrangements involving graduated measures for the application of a comprehensive guarantee are advisable. Where there is an increased risk of fraud it should be possible to prohibit temporarily the application of the comprehensive guarantee, taking account of the particular situation of the economic operators concerned. (38) It is appropriate to take account of the good faith of the person concerned in cases where a customs debt is incurred through non-compliance with the customs legislation and to minimise the impact of negligence on the part of the debtor. (39) In order to protect the financial interests of the Union and of the Member States and to supplement the rules concerning the customs debt and the guarantees, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the place of incurrence of the customs debt, the calculation of the amount of import and export duty, the guarantee of that amount and the recovery, repayment, remission and extinguishment of the customs debt. (40) It is necessary to lay down the principle of how to determine the customs status of Union goods and the circumstances pertaining to the loss of such status, and to provide a basis for determining when that status remains unaltered in cases where goods are temporarily taken out of the customs territory of the Union. (41) In order to ensure free movement of Union goods in the customs territory of the Union and customs treatment of non-Union goods brought into that territory, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the determination of the customs status of goods, the loss of the customs status of Union goods, the preservation of that status for goods temporarily leaving the customs territory of the Union and the duty relief for returned goods. (42) It is appropriate, where an economic operator has provided, in advance, the information necessary for risk-based controls on the admissibility of the goods, to ensure that quick release of goods is then the rule. Fiscal and trade policy controls should primarily be performed by the customs office competent in respect of the premises of the economic operator. (43) The rules for customs declarations and for the placing of goods under a customs procedure should be modernised and streamlined, in particular by requiring that, as a rule, customs declarations be made electronically and by providing for only one type of simplified declaration and for the possibility to lodge a customs declaration in the form of an entry in the declarant's records. (44) Since the Revised Kyoto Convention favours the lodging, registering and checking of the customs declaration prior to the arrival of the goods and, furthermore, the dissociation of the place where the declaration is lodged from the place where the goods are physically located, it is appropriate to provide for centralised clearance at the place where the economic operator is established. (45) It is appropriate to lay down at Union level the rules governing the destruction or disposal otherwise of goods by the customs authorities, since these are matters which previously required national legislation. (46) In order to supplement the rules regarding the placing of goods under a customs procedure and ensure equal treatment of the persons concerned, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the rules relating to the customs declaration and the release of goods. (47) It is appropriate to lay down common and simple rules for the special procedures, supplemented by a small set of rules for each category of special procedure, in order to make it simple for the operator to choose the right procedure, to avoid errors and to reduce the number of post-release recoveries and repayments. (48) The granting of authorisations for several special procedures with a single guarantee and a single supervising customs office should be facilitated and there should be simple rules on the incurrence of a customs debt in these cases. The basic principle should be that goods placed under a special procedure, or the products made from them, are to be assessed at the time when the customs debt is incurred. However, it should also be possible, where economically justified, to assess the goods at the time when they were placed under a special procedure. The same principles should apply to usual forms of handling. (49) In view of increased security-related measures, the placing of goods into free zones should become a customs procedure and the goods should be subject to customs controls at entry and with regard to records. (50) Given that the intention of re-export is no longer necessary, the inward processing suspension procedure should be merged with processing under customs control and the inward processing drawback procedure abandoned. This single inward processing procedure should also cover destruction, except where destruction is carried out by, or under the supervision of, customs. (51) In order to supplement the rules on special procedures and ensure equal treatment of the persons concerned, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the rules relating to cases where goods are placed under special procedures, movements, usual forms of handling and equivalence of those goods and discharge of those procedures. (52) Security-related measures relating to Union goods taken out of the customs territory of the Union should apply equally to the re-export of non-Union goods. The same rules should apply to all types of goods, with the possibility of exceptions where necessary, such as for goods only transiting through the customs territory of the Union. (53) In order to ensure the customs supervision of goods brought into and taken out of the customs territory of the Union and the application of security-related measures, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the rules relating to entry summary declaration and pre-departure declarations. (54) In order to explore further customs and trade facilitation, in particular by making use of the most recent tools and technology, Member States should be authorised, under certain conditions and upon application, to test for a limited period of time simplifications in the application of the customs legislation. That possibility should not jeopardise the application of the customs legislation or create new obligations for economic operators, who may take part in these tests on a purely voluntary basis. (55) In accordance with the principle of proportionality, as set out in Article 5 of the Treaty on European Union (TEU), it is necessary and appropriate, for the achievement of the basic objectives of enabling the customs union to function effectively and implementing the common commercial policy, to lay down the general rules and procedures applicable to goods brought into or taken out of the customs territory of the Union. In accordance with the first subparagraph of Article 5(4) TEU, this Regulation does not go beyond what is necessary in order to achieve those objectives. (56) In order to simplify and rationalise customs legislation, a number of provisions contained in autonomous Union acts have, for the sake of transparency, been incorporated into the Code. Council Regulation (EEC) No 3925/91 of 19 December 1991 concerning the elimination of controls and formalities applicable to the cabin and hold baggage of persons taking an intra-Community flight and the baggage of persons making an intra-Community sea crossing (11), Regulation (EEC) No 2913/92, Council Regulation (EC) No 1207/2001 of 11 June 2001 on procedures to facilitate the issue or the making out in the Community of proofs of origin and the issue of certain approved exporter authorisations under the provisions governing preferential trade between the European Community and certain countries (12), and Regulation (EC) No 450/2008 should therefore be repealed. (57) The provisions of this Regulation setting out the delegation of power and the conferral of implementing powers and the provisions on charges and costs should apply from the date of entry into force of this Regulation. The other provisions should apply from 1 June 2016. (58) This Regulation should be without prejudice to existing and future Union rules on access to documents adopted in accordance with Article 15(3) TFEU. It should also be without prejudice to national rules on access to documents. (59) The Commission should make every effort to ensure that the delegated and implementing acts provided for in this Regulation enter into force sufficiently in advance of the application date of the Code to allow its timely implementation by Member States, HAVE ADOPTED THIS REGULATION: TABLE OF CONTENTS TITLE I GENERAL PROVISIONS 11 CHAPTER 1 Scope of the customs legislation, mission of customs and definitions 11 CHAPTER 2 Rights and obligations of persons with regard to the customs legislation 15 Section 1 Provision of information 15 Section 2 Customs representation 18 Section 3 Decisions relating to the application of the customs legislation 19 Section 4 Authorised economic operator 24 Section 5 Penalties 25 Section 6 Appeals 26 Section 7 Control of goods 26 Section 8 Keeping of documents and other information, and charges and costs 28 CHAPTER 3 Currency conversion and time-limits 29 TITLE II FACTORS ON THE BASIS OF WHICH IMPORT OR EXPORT DUTY AND OTHER MEASURES IN RESPECT OF TRADE IN GOODS ARE APPLIED 29 CHAPTER 1 Common Customs Tariff and tariff classification of goods 29 CHAPTER 2 Origin of goods 31 Section 1 Non-preferential origin 31 Section 2 Preferential origin 31 Section 3 Determination of origin of specific goods 32 CHAPTER 3 Value of goods for customs purposes 33 TITLE III CUSTOMS DEBT AND GUARANTEES 35 CHAPTER 1 Incurrence of a customs debt 35 Section 1 Customs debt on import 35 Section 2 Customs debt on export 37 Section 3 Provisions common to customs debts incurred on import and export 38 CHAPTER 2 Guarantee for a potential or existing customs debt 39 CHAPTER 3 Recovery, payment, repayment and remission of the amount of import or export duty 42 Section 1 Determination of the amount of import or export duty, notification of the customs debt and entry in the accounts 42 Section 2 Payment of the amount of import or export duty 44 Section 3 Repayment and remission 47 CHAPTER 4 Extinguishment of a customs debt 50 TITLE IV GOODS BROUGHT INTO THE CUSTOMS TERRITORY OF THE UNION 51 CHAPTER 1 Entry summary declaration 51 CHAPTER 2 Arrival of goods 53 Section 1 Entry of goods into the customs territory of the union 53 Section 2 Presentation, unloading and examination of goods 54 Section 3 Temporary storage of goods 55 TITLE V GENERAL RULES ON CUSTOMS STATUS, PLACING GOODS UNDER A CUSTOMS PROCEDURE, VERIFICATION, RELEASE AND DISPOSAL OF GOODS 58 CHAPTER 1 Customs status of goods 58 CHAPTER 2 Placing goods under a customs procedure 59 Section 1 General provisions 59 Section 2 Standard customs declarations 60 Section 3 Simplified customs declarations 60 Section 4 Provisions applying to all customs declarations 61 Section 5 Other simplifications 63 CHAPTER 3 Verification and release of goods 65 Section 1 Verification 65 Section 2 Release 66 CHAPTER 4 Disposal of goods 66 TITLE VI RELEASE FOR FREE CIRCULATION AND RELIEF FROM IMPORT DUTY 68 CHAPTER 1 Release for free circulation 68 CHAPTER 2 Relief from import duty 68 Section 1 Returned goods 68 Section 2 Sea-fishing and products taken from the sea 69 TITLE VII SPECIAL PROCEDURES 70 CHAPTER 1 General provisions 70 CHAPTER 2 Transit 73 Section 1 External and internal transit 73 Section 2 Union transit 75 CHAPTER 3 Storage 76 Section 1 Common provisions 76 Section 2 Customs warehousing 76 Section 3 Free zones 77 CHAPTER 4 Specific use 78 Section 1 Temporary admission 78 Section 2 End-use 79 CHAPTER 5 Processing 80 Section 1 General provisions 80 Section 2 Inward processing 80 Section 3 Outward processing 81 TITLE VIII GOODS TAKEN OUT OF THE CUSTOMS TERRITORY OF THE UNION 82 CHAPTER 1 Formalities prior to the exit of goods 82 CHAPTER 2 Formalities on exit of goods 83 CHAPTER 3 Export and re-export 83 CHAPTER 4 Exit summary declaration 84 CHAPTER 5 Re-export notification 85 CHAPTER 6 Relief from export duty 86 TITLE IX ELECTRONIC SYSTEMS, SIMPLIFICATIONS, DELEGATION OF POWER, COMMITTEE PROCEDURE AND FINAL PROVISIONS 86 CHAPTER 1 Development of electronic systems 86 CHAPTER 2 Simplifications in the application of the customs legislation 86 CHAPTER 3 Delegation of power and committee procedure 87 CHAPTER 4 Final provisions 87 ANNEX CORRELATION TABLE 89 TITLE I GENERAL PROVISIONS CHAPTER 1 Scope of the customs legislation, mission of customs and definitions Article 1 Subject matter and scope 1. This Regulation establishes the Union Customs Code (the Code), laying down the general rules and procedures applicable to goods brought into or taken out of the customs territory of the Union. Without prejudice to international law and conventions and Union legislation in other fields, the Code shall apply uniformly throughout the customs territory of the Union. 2. Certain provisions of the customs legislation may apply outside the customs territory of the Union within the framework of legislation governing specific fields or of international conventions. 3. Certain provisions of the customs legislation, including the simplifications for which it provides, shall apply to the trade in Union goods between parts of the customs territory of the Union to which the provisions of Directive 2006/112/EC or of Directive 2008/118/EC apply and parts of that territory where those provisions do not apply, or to trade between parts of that territory where those provisions do not apply. Article 2 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284 specifying the provisions of the customs legislation and the simplifications thereof with respect to the customs declaration, the proof of the customs status, the use of the internal Union transit procedure insofar as it does not affect a proper application of the fiscal measures at stake, which apply to the trade in Union goods referred to in Article 1(3). Those acts may address particular circumstances pertaining to the trade in Union goods involving only one Member State. Article 3 Mission of customs authorities Customs authorities shall be primarily responsible for the supervision of the Union's international trade, thereby contributing to fair and open trade, to the implementation of the external aspects of the internal market, of the common trade policy and of the other common Union policies having a bearing on trade, and to overall supply chain security. Customs authorities shall put in place measures aimed, in particular, at the following: (a) protecting the financial interests of the Union and its Member States; (b) protecting the Union from unfair and illegal trade while supporting legitimate business activity; (c) ensuring the security and safety of the Union and its residents, and the protection of the environment, where appropriate in close cooperation with other authorities; and (d) maintaining a proper balance between customs controls and facilitation of legitimate trade. Article 4 Customs territory 1. The customs territory of the Union shall comprise the following territories, including their territorial waters, internal waters and airspace: — the territory of the Kingdom of Belgium, — the territory of the Republic of Bulgaria, — the territory of the Czech Republic, — the territory of the Kingdom of Denmark, except the Faroe Islands and Greenland, — the territory of the Federal Republic of Germany, except the Island of Heligoland and the territory of Büsingen (Treaty of 23 November 1964 between the Federal Republic of Germany and the Swiss Confederation), — the territory of the Republic of Estonia, — the territory of Ireland, — the territory of the Hellenic Republic, — the territory of the Kingdom of Spain, except Ceuta and Melilla, — the territory of the French Republic, except the French overseas countries and territories to which the provisions of Part Four of the TFEU apply, — the territory of the Republic of Croatia, — the territory of the Italian Republic, except the municipalities of Livigno and Campione d'Italia and the national waters of Lake Lugano which are between the bank and the political frontier of the area between Ponte Tresa and Porto Ceresio, — the territory of the Republic of Cyprus, in accordance with the provisions of the 2003 Act of Accession, — the territory of the Republic of Latvia, — the territory of the Republic of Lithuania, — the territory of the Grand Duchy of Luxembourg, — the territory of Hungary, — the territory of Malta, — the territory of the Kingdom of the Netherlands in Europe, — the territory of the Republic of Austria, — the territory of the Republic of Poland, — the territory of the Portuguese Republic, — the territory of Romania, — the territory of the Republic of Slovenia, — the territory of the Slovak Republic, — the territory of the Republic of Finland, — the territory of the Kingdom of Sweden, and — the territory of the United Kingdom of Great Britain and Northern Ireland and of the Channel Islands and the Isle of Man. 2. The following territories, including their territorial waters, internal waters and airspace, situated outside the territory of the Member States shall, taking into account the conventions and treaties applicable to them, be considered to be part of the customs territory of the Union: (a) FRANCE The territory of Monaco as defined in the Customs Convention signed in Paris on 18 May 1963 (Journal officiel de la République française (Official Journal of the French Republic) of 27 September 1963, p. 8679); (b) CYPRUS The territory of the United Kingdom Sovereign Base Areas of Akrotiri and Dhekelia as defined in the Treaty concerning the Establishment of the Republic of Cyprus, signed in Nicosia on 16 August 1960 (United Kingdom Treaty Series No 4 (1961) Cmnd. 1252). Article 5 Definitions For the purposes of the Code, the following definitions shall apply: (1) "customs authorities" means the customs administrations of the Member States responsible for applying the customs legislation and any other authorities empowered under national law to apply certain customs legislation; (2) "customs legislation" means the body of legislation made up of all of the following: (a) the Code and the provisions supplementing or implementing it adopted at Union or national level; (b) the Common Customs Tariff; (c) the legislation setting up a Union system of reliefs from customs duty; (d) international agreements containing customs provisions, insofar as they are applicable in the Union; (3) "customs controls" means specific acts performed by the customs authorities in order to ensure compliance with the customs legislation and other legislation governing the entry, exit, transit, movement, storage and end-use of goods moved between the customs territory of the Union and countries or territories outside that territory, and the presence and movement within the customs territory of the Union of non-Union goods and goods placed under the end-use procedure; (4) "person" means a natural person, a legal person, and any association of persons which is not a legal person but which is recognised under Union or national law as having the capacity to perform legal acts; (5) "economic operator" means a person who, in the course of his or her business, is involved in activities covered by the customs legislation; (6) "customs representative" means any person appointed by another person to carry out the acts and formalities required under the customs legislation in his or her dealings with customs authorities; (7) "risk" means the likelihood and the impact of an event occurring, with regard to the entry, exit, transit, movement or end-use of goods moved between the customs territory of the Union and countries or territories outside that territory and to the presence within the customs territory of the Union of non-Union goods, which would: (a) prevent the correct application of Union or national measures; (b) compromise the financial interests of the Union and its Member States; or (c) pose a threat to the security and safety of the Union and its residents, to human, animal or plant health, to the environment or to consumers; (8) "customs formalities" means all the operations which must be carried out by a person and by the customs authorities in order to comply with the customs legislation; (9) "entry summary declaration" means the act whereby a person informs the customs authorities, in the prescribed form and manner and within a specific time-limit, that goods are to be brought into the customs territory of the Union; (10) "exit summary declaration" means the act whereby a person informs the customs authorities, in the prescribed form and manner and within a specific time-limit, that goods are to be taken out of the customs territory of the Union; (11) "temporary storage declaration" means the act whereby a person indicates, in the prescribed form and manner, that goods are in temporary storage; (12) "customs declaration" means the act whereby a person indicates, in the prescribed form and manner, a wish to place goods under a given customs procedure, with an indication, where appropriate, of any specific arrangements to be applied; (13) "re-export declaration" means the act whereby a person indicates, in the prescribed form and manner, a wish to take non-Union goods, with the exception of those under the free zone procedure or in temporary storage, out of the customs territory of the Union; (14) "re-export notification" means the act whereby a person indicates, in the prescribed form and manner, a wish to take non-Union goods which are under the free zone procedure or in temporary storage out of the customs territory of the Union; (15) "declarant" means the person lodging a customs declaration, a temporary storage declaration, an entry summary declaration, an exit summary declaration, a re-export declaration or a re-export notification in his or her own name or the person in whose name such a declaration or notification is lodged; (16) "customs procedure" means any of the following procedures under which goods may be placed in accordance with the Code: (a) release for free circulation; (b) special procedures; (c) export; (17) 'temporary storage' means the situation of non-Union goods temporarily stored under customs supervision in the period between their presentation to customs and their placing under a customs procedure or re-export; (18) "customs debt" means the obligation on a person to pay the amount of import or export duty which applies to specific goods under the customs legislation in force; (19) "debtor" means any person liable for a customs debt; (20) "import duty" means customs duty payable on the import of goods; (21) "export duty" means customs duty payable on the export of goods; (22) "customs status" means the status of goods as Union or non-Union goods; (23) "Union goods" means goods which fall into any of the following categories: (a) goods wholly obtained in the customs territory of the Union and not incorporating goods imported from countries or territories outside the customs territory of the Union; (b) goods brought into the customs territory of the Union from countries or territories outside that territory and released for free circulation; (c) goods obtained or produced in the customs territory of the Union, either solely from goods referred to in point (b) or from goods referred to in points (a) and (b); (24) "non-Union goods" means goods other than those referred to in point 23 or which have lost their customs status as Union goods; (25) "risk management" means the systematic identification of risk, including through random checks, and the implementation of all measures necessary for limiting exposure to risk; (26) "release of goods" means the act whereby the customs authorities make goods available for the purposes specified for the customs procedure under which they are placed; (27) "customs supervision" means action taken in general by the customs authorities with a view to ensuring that customs legislation and, where appropriate, other provisions applicable to goods subject to such action are observed; (28) "repayment" means the refunding of an amount of import or export duty that has been paid; (29) "remission" means the waiving of the obligation to pay an amount of import or export duty which has not been paid; (30) "processed products" means goods placed under a processing procedure which have undergone processing operations; (31) "person established in the customs territory of the Union" means: (a) in the case of a natural person, any person who has his or her habitual residence in the customs territory of the Union; (b) in the case of a legal person or an association of persons, any person having its registered office, central headquarters or a permanent business establishment in the customs territory of the Union; (32) "permanent business establishment" means a fixed place of business, where both the necessary human and technical resources are permanently present and through which a person's customs-related operations are wholly or partly carried out; (33) "presentation of goods to customs" means the notification to the customs authorities of the arrival of goods at the customs office or at any other place designated or approved by the customs authorities and the availability of those goods for customs controls; (34) "holder of the goods" means the person who is the owner of the goods or who has a similar right of disposal over them or who has physical control of them; (35) "holder of the procedure" means: (a) the person who lodges the customs declaration, or on whose behalf that declaration is lodged; or (b) the person to whom the rights and obligations in respect of a customs procedure have been transferred; (36) "commercial policy measures" means non-tariff measures established, as part of the common commercial policy, in the form of Union provisions governing international trade in goods; (37) "processing operations" means any of the following: (a) the working of goods, including erecting or assembling them or fitting them to other goods; (b) the processing of goods; (c) the destruction of goods; (d) the repair of goods, including restoring them and putting them in order; (e) the use of goods which are not to be found in the processed products, but which allow or facilitate the production of those products, even if they are entirely or partially used up in the process (production accessories); (38) "rate of yield" means the quantity or percentage of processed products obtained from the processing of a given quantity of goods placed under a processing procedure; (39) "decision" means any act by the customs authorities pertaining to the customs legislation giving a ruling on a particular case, and having legal effects on the person or persons concerned; (40) "carrier" means: (a) in the context of entry, the person who brings the goods, or who assumes responsibility for the carriage of the goods, into the customs territory of the Union. However, (i) in the case of combined transportation, "carrier" means the person who operates the means of transport which, once brought into the customs territory of the Union, moves by itself as an active means of transport; (ii) in the case of maritime or air traffic under a vessel-sharing or contracting arrangement, "carrier" means the person who concludes a contract and issues a bill of lading or air waybill for the actual carriage of the goods into the customs territory of the Union; (b) in the context of exit, the person who takes the goods, or who assumes responsibility for the carriage of the goods, out of the customs territory of the Union. However: (i) in the case of combined transportation, where the active means of transport leaving the customs territory of the Union is only transporting another means of transport which, after the arrival of the active means of transport at its destination, will move by itself as an active means of transport, 'carrier' means the person who will operate the means of transport which will move by itself once the means of transport leaving the customs territory of the Union has arrived at its destination; (ii) in the case of maritime or air traffic under a vessel-sharing or contracting arrangement, "carrier" means the person who concludes a contract, and issues a bill of lading or air waybill, for the actual carriage of the goods out of the customs territory of the Union; (41) "buying commission" means a fee paid by an importer to an agent for representing him or her in the purchase of goods being valued. CHAPTER 2 Rights and obligations of persons with regard to the customs legislation Section 1 Provision of information Article 6 Means for the exchange and storage of information and common data requirements 1. All exchanges of information, such as declarations, applications or decisions, between customs authorities and between economic operators and customs authorities, and the storage of such information, as required under the customs legislation, shall be made using electronic data-processing techniques. 2. Common data requirements shall be drawn up for the purpose of the exchange and storage of information referred to in paragraph 1. 3. Means for the exchange and storage of information, other than the electronic data-processing techniques referred to in paragraph 1, may be used as follows: (a) on a permanent basis where duly justified by the type of traffic or where the use of electronic data-processing techniques is not appropriate for the customs formalities concerned; (b) on a temporary basis, in the event of a temporary failure of the computerised system of the customs authorities or of the economic operators. 4. By way of derogation from paragraph 1, the Commission may adopt in exceptional cases decisions allowing one or several Member States to use means for the exchange and storage of information other than electronic data-processing techniques. Such a decision on a derogation shall be justified by the specific situation of the Member State requesting it and the derogation shall be granted for a specific period of time. The derogation shall be reviewed periodically and may be extended for further specific periods of time upon further application by the Member State to which it is addressed. It shall be revoked where no longer justified. The derogation shall not affect the exchange of information between the Member State to which it is addressed and other Member States nor the exchange and storage of information in other Member States for the purpose of the application of the customs legislation. Article 7 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the following: (a) the common data requirements referred to in Article 6(2), taking into account the need to accomplish the customs formalities laid down in the customs legislation and the nature and purpose of the exchange and storage of information referred to in Article 6(1); (b) the specific cases where means for the exchange and storage of information, other than electronic data-processing techniques, may be used in accordance with point (a) of Article 6(3); (c) the type of information and the particulars that are to be contained in the records referred to in Articles 148(4) and 214(1). Article 8 Conferral of implementing powers 1. The Commission shall specify, by means of implementing acts: (a) where necessary, the format and code of the common data requirements referred to in Article 6(2); (b) the procedural rules on the exchange and storage of information which can be made by means other than the electronic data-processing techniques referred to in Article 6(3). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). 2. The Commission shall adopt the decisions on derogations referred to in Article 6(4) by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 285(2). Article 9 Registration 1. Economic operators established in the customs territory of the Union shall register with the customs authorities responsible for the place where they are established. 2. In specific cases, economic operators which are not established in the customs territory of the Union shall register with the customs authorities responsible for the place where they first lodge a declaration or apply for a decision. 3. Persons other than economic operators shall not be required to register with the customs authorities unless otherwise provided. Where persons referred to in the first subparagraph are required to register, the following shall apply: (a) where they are established in the customs territory of the Union, they shall register with the customs authorities responsible for the place where they are established; (b) where they are not established in the customs territory of the Union, they shall register with the customs authorities responsible for the place where they first lodge a declaration or apply for a decision. 4. In specific cases, the customs authorities shall invalidate the registration. Article 10 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, in order to determine: (a) the cases referred to in Article 9(2), where economic operators which are not established in the customs territory of the Union are required to register with the customs authorities; (b) the cases referred to in the first subparagraph of Article 9(3), where persons other than economic operators are required to register with the customs authorities; (c) the cases referred to in Article 9(4) where the customs authorities invalidate a registration. Article 11 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the customs authority responsible for the registration referred to in Article 9. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 12 Communication of information and data protection 1. All information acquired by the customs authorities in the course of performing their duty which is by its nature confidential or which is provided on a confidential basis shall be covered by the obligation of professional secrecy. Except as provided for in Article 47(2), such information shall not be disclosed by the competent authorities without the express permission of the person or authority that provided it. Such information may, however, be disclosed without permission where the customs authorities are obliged or authorised to do so pursuant to the provisions in force, particularly in respect of data protection, or in connection with legal proceedings. 2. Confidential information referred to in paragraph 1 may be communicated to the customs authorities and other competent authorities of countries or territories outside the customs territory of the Union for the purpose of customs cooperation with those countries or territories in the framework of an international agreement or Union legislation in the area of the common commercial policy. 3. Any disclosure or communication of information as referred to in paragraphs 1 and 2 shall ensure an adequate level of data protection in full compliance with data protection provisions in force. Article 13 Exchange of additional information between customs authorities and economic operators 1. Customs authorities and economic operators may exchange any information not specifically required under the customs legislation, in particular for the purpose of mutual cooperation in the identification and counteraction of risk. That exchange may take place under a written agreement and may include access to the computer systems of economic operators by the customs authorities. 2. Any information provided by one party to the other in the course of the cooperation referred to in paragraph 1 shall be confidential unless both parties agree otherwise. Article 14 Provision of information by the customs authorities 1. Any person may request information concerning the application of the customs legislation from the customs authorities. Such a request may be refused where it does not relate to an activity pertaining to international trade in goods that is actually envisaged. 2. Customs authorities shall maintain a regular dialogue with economic operators and other authorities involved in international trade in goods. They shall promote transparency by making the customs legislation, general administrative rulings and application forms freely available, wherever practical without charge, and through the Internet. Article 15 Provision of information to the customs authorities 1. Any person directly or indirectly involved in the accomplishment of customs formalities or in customs controls shall, at the request of the customs authorities and within any time-limit specified, provide those authorities with all the requisite documents and information, in an appropriate form, and all the assistance necessary for the completion of those formalities or controls. 2. The lodging of a customs declaration, temporary storage declaration, entry summary declaration, exit summary declaration, re-export declaration or re-export notification by a person to the customs authorities, or the submission of an application for an authorisation or any other decision, shall render the person concerned responsible for all of the following: (a) the accuracy and completeness of the information given in the declaration, notification or application; (b) the authenticity, accuracy and validity of any document supporting the declaration, notification or application; (c) where applicable, compliance with all of the obligations relating to the placing of the goods in question under the customs procedure concerned, or to the conduct of the authorised operations. The first subparagraph shall also apply to the provision of any information in any other form required by, or given to, the customs authorities. Where the declaration or notification is lodged, the application is submitted, or information is provided, by a customs representative of the person concerned, as referred to in Article 18, that customs representative shall also be bound by the obligations set out in the first subparagraph of this paragraph. Article 16 Electronic systems 1. Member States shall cooperate with the Commission to develop, maintain and employ electronic systems for the exchange of information between customs authorities and with the Commission and for the storage of such information, in accordance with the Code. 2. Member States to which a derogation has been granted in accordance with Article 6(4) shall not be required to develop, maintain and employ within the scope of that derogation the electronic systems referred to in paragraph 1 of this Article. Article 17 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the technical arrangements for developing, maintaining and employing the electronic systems referred to in Article 16(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Customs representation Article 18 Customs representative 1. Any person may appoint a customs representative. Such representation may be either direct, in which case the customs representative shall act in the name of and on behalf of another person, or indirect, in which case the customs representative shall act in his or her own name but on behalf of another person. 2. A customs representative shall be established within the customs territory of the Union. Except where otherwise provided, that requirement shall be waived where the customs representative acts on behalf of persons who are not required to be established within the customs territory of the Union. 3. Member States may determine, in accordance with Union law, the conditions under which a customs representative may provide services in the Member State where he or she is established. However, without prejudice to the application of less stringent criteria by the Member State concerned, a customs representative who complies with the criteria laid down in points (a) to (d) of Article 39 shall be entitled to provide such services in a Member State other than the one where he or she is established. 4. Member States may apply the conditions determined in accordance with the first sentence of paragraph 3 to customs representatives not established within the customs territory of the Union. Article 19 Empowerment 1. When dealing with the customs authorities, a customs representative shall state that he or she is acting on behalf of the person represented and shall specify whether the representation is direct or indirect. Persons who fail to state that they are acting as a customs representative or who state that they are acting as a customs representative without being empowered to do so shall be deemed to be acting in their own name and on their own behalf. 2. The customs authorities may require persons stating that they are acting as a customs representative to provide evidence of their empowerment by the person represented. In specific cases, the customs authorities shall not require such evidence to be provided. 3. The customs authorities shall not require a person acting as a customs representative, carrying out acts and formalities on a regular basis, to produce on every occasion evidence of empowerment, provided that such person is in a position to produce such evidence on request by the customs authorities. Article 20 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the cases where the waiver referred to in the second subparagraph of Article 18(2) does not apply; (b) the cases where the evidence of empowerment referred to in the first subparagraph of Article 19(2) is not required by the customs authorities. Article 21 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules on the conferral and proving of the entitlement referred to in Article 18(3). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 3 Decisions relating to the application of the customs legislation Article 22 Decisions taken upon application 1. Where a person applies for a decision relating to the application of the customs legislation, that person shall supply all the information required by the competent customs authorities in order to enable them to take that decision. A decision may also be applied for by, and taken with regard to, several persons, in accordance with the conditions laid down in the customs legislation. Except where otherwise provided, the competent customs authority shall be that of the place where the applicant's main accounts for customs purposes are held or accessible, and where at least part of the activities to be covered by the decision are to be carried out. 2. Customs authorities shall, without delay and at the latest within 30 days of receipt of the application for a decision, verify whether the conditions for the acceptance of that application are fulfilled. Where the customs authorities establish that the application contains all the information required in order for them to be able to take the decision, they shall communicate its acceptance to the applicant within the period specified in the first subparagraph. 3. The competent customs authority shall take a decision as referred to in paragraph 1, and shall notify the applicant without delay, and at the latest within 120 days of the date of acceptance of the application, except where otherwise provided Where the customs authorities are unable to comply with the time-limit for taking a decision, they shall inform the applicant of that fact before the expiry of that time-limit, stating the reasons and indicating the further period of time which they consider necessary in order to take a decision. Except where otherwise provided, that further period of time shall not exceed 30 days. Without prejudice to the second subparagraph, the customs authorities may extend the time-limit for taking a decision, as laid down in the customs legislation, where the applicant requests an extension to carry out adjustments in order to ensure the fulfilment of the conditions and criteria. Those adjustments and the further period of time necessary to carry them out shall be communicated to the customs authorities, which shall decide on the extension. 4. Except where otherwise specified in the decision or in the customs legislation, the decision shall take effect from the date on which the applicant receives it, or is deemed to have received it. Except in the cases provided for in Article 45(2), decisions adopted shall be enforceable by the customs authorities from that date. 5. Except where otherwise provided in the customs legislation, the decision shall be valid without limitation of time. 6. Before taking a decision which would adversely affect the applicant, the customs authorities shall communicate the grounds on which they intend to base their decision to the applicant, who shall be given the opportunity to express his or her point of view within a period prescribed from the date on which he or she receives that communication or is deemed to have received it. Following the expiry of that period, the applicant shall be notified, in the appropriate form, of the decision. The first subparagraph shall not apply in any of the following cases: (a) where it concerns a decision referred to in Article 33(1); (b) in the event of refusal of the benefit of a tariff quota where the specified tariff quota volume is reached, as referred to in the first subparagraph of Article 56(4); (c) where the nature or the level of a threat to the security and safety of the Union and its residents, to human, animal or plant health, to the environment or to consumers so requires; (d) where the decision aims at securing the implementation of another decision for which the first subparagraph has been applied, without prejudice to the law of the Member State concerned; (e) where it would prejudice investigations initiated for the purpose of combating fraud; (f) in other specific cases. 7. A decision which adversely affects the applicant shall set out the grounds on which it is based and shall refer to the right of appeal provided for in Article 44. Article 23 Management of decisions taken upon application 1. The holder of the decision shall comply with the obligations resulting from that decision. 2. The holder of the decision shall inform the customs authorities without delay of any factor arising after the decision was taken, which may influence its continuation or content. 3. Without prejudice to provisions laid down in other fields which specify the cases in which decisions are invalid or become null and void, the customs authorities which took a decision may at any time annul, amend or revoke it where it does not conform to the customs legislation. 4. In specific cases the customs authorities shall carry out the following: (a) re-assess a decision; (b) suspend a decision which is not to be annulled, revoked or amended. 5. The customs authorities shall monitor the conditions and criteria to be fulfilled by the holder of a decision. They shall also monitor compliance with the obligations resulting from that decision. Where the holder of the decision has been established for less than three years, the customs authorities shall closely monitor it during the first year after the decision is taken. Article 24 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, in order to determine: (a) the exceptions to the third subparagraph of Article 22(1); (b) the conditions for the acceptance of an application, referred to in Article 22(2); (c) the time-limit to take a specific decision, including the possible extension of that time-limit, in accordance with Article 22(3); (d) the cases, referred to in Article 22(4), where the decision takes effect from a date which is different from the date on which the applicant receives it or is deemed to have received it; (e) the cases, referred to in Article 22(5), where the decision is not valid without limitation of time; (f) the duration of the period referred to in the first subparagraph of Article 22(6); (g) the specific cases, referred to in point (f) of the second subparagraph of Article 22(6), where the applicant is given no opportunity to express his or her point of view; (h) the cases and the rules for re-assessing and suspending decisions in accordance with Article 23(4); Article 25 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) the submission and the acceptance of the application for a decision, referred to in Article 22(1) and (2); (b) taking the decision referred to in Article 22, including, where appropriate, the consultation of the Member States concerned; (c) monitoring a decision, in accordance with Article 23(5). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 26 Union-wide validity of decisions Except where the effect of a decision is limited to one or several Member States, decisions relating to the application of the customs legislation shall be valid throughout the customs territory of the Union. Article 27 Annulment of favourable decisions 1. The customs authorities shall annul a decision favourable to the holder of the decision if all the following conditions are fulfilled: (a) the decision was taken on the basis of incorrect or incomplete information; (b) the holder of the decision knew or ought reasonably to have known that the information was incorrect or incomplete; (c) if the information had been correct and complete, the decision would have been different. 2. The holder of the decision shall be notified of its annulment. 3. Annulment shall take effect from the date on which the initial decision took effect, unless otherwise specified in the decision in accordance with the customs legislation. Article 28 Revocation and amendment of favourable decisions 1. A favourable decision shall be revoked or amended where, in cases other than those referred to in Article 27: (a) one or more of the conditions for taking that decision were not or are no longer fulfilled; or (b) upon application by the holder of the decision. 2. Except where otherwise provided, a favourable decision addressed to several persons may be revoked only in respect of a person who fails to fulfil an obligation imposed under that decision. 3. The holder of the decision shall be notified of its revocation or amendment. 4. Article 22(4) shall apply to the revocation or amendment of the decision. However, in exceptional cases where the legitimate interests of the holder of the decision so require, the customs authorities may defer the date on which revocation or amendment takes effect up to one year. That date shall be indicated in the revoking or amending decision. Article 29 Decisions taken without prior application Except when a customs authority acts as a judicial authority, Article 22(4), (5), (6) and (7), Article 23(3) and Articles 26, 27 and 28 shall also apply to decisions taken by the customs authorities without prior application by the person concerned. Article 30 Limitations applicable to decisions on goods placed under a customs procedure or in temporary storage Except where the person concerned so requests, the revocation, amendment or suspension of a favourable decision shall not affect goods which, at the moment where the revocation, amendment or suspension takes effect, have already been placed and are still under a customs procedure or in temporary storage by virtue of the revoked, amended or suspended decision. Article 31 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the cases, referred to in Article 28(2), where a favourable decision addressed to several persons may be revoked also in respect of persons other than the person who fails to fulfil an obligation imposed under that decision; (b) the exceptional cases, in which the customs authorities may defer the date on which revocation or amendment takes effect in accordance with the second subparagraph of Article 28(4). Article 32 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for annulling, revoking or amending favourable decisions. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 33 Decisions relating to binding information 1. The customs authorities shall, upon application, take decisions relating to binding tariff information (BTI decisions), or decisions relating to binding origin information (BOI decisions). Such an application shall not be accepted in any of the following circumstances: (a) where the application is made, or has already been made, at the same or another customs office, by or on behalf of the holder of a decision in respect of the same goods and, for BOI decisions, under the same circumstances determining the acquisition of origin; (b) where the application does not relate to any intended use of the BTI or BOI decision or any intended use of a customs procedure. 2. BTI or BOI decisions shall be binding, only in respect of the tariff classification or determination of the origin of goods: (a) on the customs authorities, as against the holder of the decision, only in respect of goods for which customs formalities are completed after the date on which the decision takes effect; (b) on the holder of the decision, as against the customs authorities, only with effect from the date on which he or she receives, or is deemed to have received, notification of the decision. 3. BTI or BOI decisions shall be valid for a period of three years from the date on which the decision takes effect. 4. For the application of a BTI or BOI decision in the context of a particular customs procedure, the holder of the decision shall be able to prove that: (a) in the case of a BTI decision, the goods declared correspond in every respect to those described in the decision; (b) in the case of a BOI decision, the goods in question and the circumstances determining the acquisition of origin correspond in every respect to the goods and the circumstances described in the decision. Article 34 Management of decisions relating to binding information 1. A BTI decision shall cease to be valid before the end of the period referred to in Article 33(3) where it no longer conforms to the law, as a result of either of the following: (a) the adoption of an amendment to the nomenclatures referred to in points (a) and (b) of Article 56(2); (b) the adoption of measures referred to in Article 57(4); with effect from the date of application of such amendment or measures. 2. A BOI decision shall cease to be valid before the end of the period referred to in Article 33(3) in any of the following cases: (a) where a regulation is adopted or an agreement is concluded by, and becomes applicable in, the Union, and the BOI decision no longer conforms to the law thereby laid down, with effect from the date of application of that regulation or agreement; (b) where it is no longer compatible with the Agreement on Rules of Origin established in the World Trade Organisation (WTO) or with the explanatory notes or an origin opinion adopted for the interpretation of that Agreement, with effect from the date of their publication in the Official Journal of the European Union. 3. BTI or BOI decisions shall not cease to be valid with retroactive effect. 4. By way of derogation from Article 23(3) and Article 27, BTI and BOI decisions shall be annulled where they are based on inaccurate or incomplete information from the applicants. 5. BTI and BOI decisions shall be revoked in accordance with Article 23(3) and Article 28. However, such decisions shall not be revoked upon application by the holder of the decision. 6. BTI and BOI decisions may not be amended. 7. The customs authorities shall revoke BTI decisions: (a) where they are no longer compatible with the interpretation of any of the nomenclatures referred to in points (a) and (b) of Article 56(2) resulting from any of the following: (i) explanatory notes referred to in the second indent of point (a) of Article 9(1) of Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (13), with effect from the date of their publication in the Official Journal of the European Union; (ii) a judgment of the Court of Justice of the European Union, with effect from the date of publication of the operative part of the judgment in the Official Journal of the European Union; (iii) classification decisions, classification opinions or amendments of the explanatory notes to the Nomenclature of the Harmonized Commodity Description and Coding System, adopted by the Organization set-up by the Convention establishing a Customs Co-operation Council, done at Brussels on 15 December 1950, with effect from the date of publication of the Commission Communication in the 'C' series of the Official Journal of the European Union; or (b) in other specific cases. 8. BOI decisions shall be revoked: (a) where they are no longer compatible with a judgment of the Court of Justice of the European Union, with effect from the date of publication of the operative part of the judgment in the Official Journal of the European Union; or (b) in other specific cases. 9. Where point (b) of paragraph 1 or paragraphs 2, 7 or 8 apply, a BTI or BOI decision may still be used in respect of binding contracts which were based upon that decision and were concluded before it ceased to be valid or was revoked. That extended use shall not apply where a BOI decision is taken for goods to be exported. The extended use referred to in the first subparagraph shall not exceed six months from the date on which the BTI or BOI decision ceases to be valid or is revoked. However, a measure referred to in Article 57(4) or in Article 67 may exclude that extended use or lay down a shorter period of time. In the case of products for which an import or export certificate is submitted when customs formalities are carried out, the period of six months shall be replaced by the period of validity of the certificate. In order to benefit from the extended use of a BTI or BOI decision, the holder of that decision shall lodge an application to the customs authority that took the decision within 30 days of the date on which it ceases to be valid or is revoked, indicating the quantities for which a period of extended use is requested and the Member State or Member States in which goods will be cleared under the period of extended use. That customs authority shall take a decision on the extended use and notify the holder, without delay, and at the latest within 30 days of the date on which it receives all the information required in order to enable it to take that decision. 10. The Commission shall notify the customs authorities where: (a) the taking of BTI and BOI decisions, for goods whose correct and uniform tariff classification or determination of origin is not ensured, is suspended; or (b) the suspension referred to in point (a) is withdrawn. 11. The Commission may adopt decisions requesting Member States to revoke BTI or BOI decisions, to ensure a correct and uniform tariff classification or determination of the origin of goods. Article 35 Decisions relating to binding information with regard to other factors In specific cases, the customs authorities shall, upon application, take decisions relating to binding information with regard to other factors referred to in Title II, on the basis of which import or export duty and other measures in respect of trade in goods are applied. Article 36 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the specific cases referred to in point (b) of Article 34(7) and point (b) of Article 34(8), where BTI and BOI decisions are to be revoked; (b) the cases referred to in Article 35, where decisions relating to binding information are taken with regard to other factors on the basis of which import or export duty and other measures in respect of trade in goods are applied. Article 37 Conferral of implementing powers 1. The Commission shall adopt, by means of implementing acts, the procedural rules for: (a) using a BTI or BOI decision after it ceases to be valid or is revoked, in accordance with Article 34(9); (b) the Commission to notify the customs authorities in accordance with points (a) and (b) of Article 34(10); (c) using decisions referred to in Article 35 and determined in accordance with point (b) of Article 36 after they cease to be valid; (d) suspending decisions referred to in Article 35 and determined in accordance with point (b) of Article 36 and notifying the suspension or the withdrawal of the suspension to the customs authorities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). 2. The Commission shall adopt, by means of implementing acts, the decisions requesting Member States to revoke: (a) decisions referred to in Article 34(11); (b) decisions referred to in Article 35 and determined in accordance with point (b) of Article 36. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 285(2). Where the opinion of the committee referred to in Article 285(1) is to be obtained by written procedure, Article 285(6) shall apply. Section 4 Authorised economic operator Article 38 Application and authorisation 1. An economic operator who is established in the customs territory of the Union and who meets the criteria set out in Article 39 may apply for the status of authorised economic operator. The customs authorities shall, following consultation with other competent authorities if necessary, grant that status, which shall be subject to monitoring. 2. The status of authorised economic operator shall consist in the following types of authorisations: (a) that of an authorised economic operator for customs simplifications, which shall enable the holder to benefit from certain simplifications in accordance with the customs legislation; or (b) that of an authorised economic operator for security and safety that shall entitle the holder to facilitations relating to security and safety. 3. Both types of authorisations referred to in paragraph 2 may be held at the same time. 4. The status of authorised economic operator shall, subject to Articles 39, 40 and 41, be recognised by the customs authorities in all Member States. 5. Customs authorities shall, on the basis of the recognition of the status of authorised economic operator for customs simplifications and provided that the requirements related to a specific type of simplification provided for in the customs legislation are fulfilled, authorise the operator to benefit from that simplification. Customs authorities shall not re-examine those criteria which have already been examined when granting the status of authorised economic operator. 6. The authorised economic operator referred to in paragraph 2 shall enjoy more favourable treatment than other economic operators in respect of customs controls according to the type of authorisation granted, including fewer physical and document-based controls. 7. The customs authorities shall grant benefits resulting from the status of authorised economic operator to persons established in countries or territories outside the customs territory of the Union, who fulfil conditions and comply with obligations defined by the relevant legislation of those countries or territories, insofar as those conditions and obligations are recognised by the Union as equivalent to those imposed to authorised economic operators established in the customs territory of the Union. Such a granting of benefits shall be based on the principle of reciprocity unless otherwise decided by the Union, and shall be supported by an international agreement or Union legislation in the area of the common commercial policy. Article 39 Granting of status The criteria for the granting of the status of authorised economic operator shall be the following: (a) the absence of any serious infringement or repeated infringements of customs legislation and taxation rules, including no record of serious criminal offences relating to the economic activity of the applicant; (b) the demonstration by the applicant of a high level of control of his or her operations and of the flow of goods, by means of a system of managing commercial and, where appropriate, transport records, which allows appropriate customs controls; (c) financial solvency, which shall be deemed to be proven where the applicant has good financial standing, which enables him or her to fulfil his or her commitments, with due regard to the characteristics of the type of business activity concerned; (d) with regard to the authorisation referred to in point (a) of Article 38(2), practical standards of competence or professional qualifications directly related to the activity carried out; and (e) with regard to the authorisation referred to in point (b) of Article 38(2), appropriate security and safety standards, which shall be considered as fulfilled where the applicant demonstrates that he or she maintains appropriate measures to ensure the security and safety of the international supply chain including in the areas of physical integrity and access controls, logistical processes and handling of specific types of goods, personnel and identification of his or her business partners. Article 40 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the following: (a) the simplifications referred to in point (a) of Article 38(2); (b) the facilitations referred to in point (b) of Article 38(2); (c) the more favourable treatment referred to in Article 38(6). Article 41 Conferral of implementing powers The Commission shall adopt, by means of implementing acts, the modalities for the application of the criteria referred to in Article 39. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 5 Penalties Article 42 Application of penalties 1. Each Member State shall provide for penalties for failure to comply with the customs legislation. Such penalties shall be effective, proportionate and dissuasive. 2. Where administrative penalties are applied, they may take, inter alia, one or both of the following forms: (a) a pecuniary charge by the customs authorities, including, where appropriate, a settlement applied in place of and in lieu of a criminal penalty; (b) the revocation, suspension or amendment of any authorisation held by the person concerned. 3. Member States shall notify the Commission, within 180 days from the date of application of this Article, as determined in accordance with Article 288(2), of the national provisions in force, as envisaged in paragraph 1 of this Article, and shall notify it without delay of any subsequent amendment affecting those provisions. Section 6 Appeals Article 43 Decisions taken by a judicial authority Articles 44 and 45 shall not apply to appeals lodged with a view to the annulment, revocation or amendment of a decision relating to the application of the customs legislation taken by a judicial authority, or by customs authorities acting as judicial authorities. Article 44 Right of appeal 1. Any person shall have the right to appeal against any decision taken by the customs authorities relating to the application of the customs legislation which concerns him or her directly and individually. Any person who has applied to the customs authorities for a decision and has not obtained a decision on that application within the time-limits referred to in Article 22(3) shall also be entitled to exercise the right of appeal. 2. The right of appeal may be exercised in at least two steps: (a) initially, before the customs authorities or a judicial authority or other body designated for that purpose by the Member States; (b) subsequently, before a higher independent body, which may be a judicial authority or an equivalent specialised body, according to the provisions in force in the Member States. 3. The appeal shall be lodged in the Member State where the decision was taken or was applied for. 4. Member States shall ensure that the appeals procedure enables the prompt confirmation or correction of decisions taken by the customs authorities. Article 45 Suspension of implementation 1. The submission of an appeal shall not cause implementation of the disputed decision to be suspended. 2. The customs authorities shall, however, suspend implementation of such a decision in whole or in part where they have good reason to believe that the disputed decision is inconsistent with the customs legislation or that irreparable damage is to be feared for the person concerned. 3. In the cases referred to in paragraph 2, where the disputed decision has the effect of causing import or export duty to be payable, suspension of implementation of that decision shall be conditional upon the provision of a guarantee, unless it is established, on the basis of a documented assessment, that such a guarantee would be likely to cause the debtor serious economic or social difficulties. Section 7 Control of goods Article 46 Risk management and customs controls 1. The customs authorities may carry out any customs controls they deem necessary. Customs controls may in particular consist of examining goods, taking samples, verifying the accuracy and completeness of the information given in a declaration or notification and the existence, authenticity, accuracy and validity of documents, examining the accounts of economic operators and other records, inspecting means of transport, inspecting luggage and other goods carried by or on persons and carrying out official enquiries and other similar acts. 2. Customs controls, other than random checks, shall primarily be based on risk analysis using electronic data-processing techniques, with the purpose of identifying and evaluating the risks and developing the necessary counter-measures, on the basis of criteria developed at national, Union and, where available, international level. 3. Customs controls shall be performed within a common risk management framework, based upon the exchange of risk information and risk analysis results between customs administrations and establishing common risk criteria and standards, control measures and priority control areas. Controls based upon such information and criteria shall be carried out without prejudice to other controls carried out in accordance with paragraph 1 or with other provisions in force. 4. Customs authorities shall undertake risk management to differentiate between the levels of risk associated with goods subject to customs control or supervision and to determine whether the goods will be subject to specific customs controls, and if so, where. The risk management shall include activities such as collecting data and information, analysing and assessing risk, prescribing and taking action and regularly monitoring and reviewing that process and its outcomes, based on international, Union and national sources and strategies. 5. Customs authorities shall exchange risk information and risk analysis results where: (a) the risks are assessed by a customs authority as being significant and requiring customs control and the results of the control establish that the event triggering the risks has occurred; or (b) the control results do not establish that the event triggering the risks has occurred, but the customs authority concerned considers the threat to present a high risk elsewhere in the Union. 6. For the establishment of the common risk criteria and standards, the control measures and the priority control areas referred to in paragraph 3, account shall be taken of all of the following: (a) the proportionality to the risk; (b) the urgency of the necessary application of the controls; (c) the probable impact on trade flow, on individual Member States and on control resources. 7. The common risk criteria and standards referred to in paragraph 3 shall include all of the following: (a) a description of the risks; (b) the factors or indicators of risk to be used to select goods or economic operators for customs control; (c) the nature of customs controls to be undertaken by the customs authorities; (d) the duration of the application of the customs controls referred to in point (c). 8. Priority control areas shall cover particular customs procedures, types of goods, traffic routes, modes of transport or economic operators which are subject to increased levels of risk analysis and customs controls during a certain period, without prejudice to other controls usually carried out by the customs authorities. Article 47 Cooperation between authorities 1. Where, in respect of the same goods, controls other than customs controls are to be performed by competent authorities other than the customs authorities, customs authorities shall, in close cooperation with those other authorities, endeavour to have those controls performed, wherever possible, at the same time and place as customs controls (one-stop-shop), with customs authorities having the coordinating role in achieving this. 2. In the framework of the controls referred to in this Section, customs and other competent authorities may, where necessary for the purposes of minimising risk and combating fraud, exchange with each other and with the Commission data received in the context of the entry, exit, transit, movement, storage and end-use of goods, including postal traffic, moved between the customs territory of the Union and countries or territories outside the customs territory of the Union, the presence and movement within the customs territory of the Union of non-Union goods and goods placed under the end-use procedure, and the results of any control. Customs authorities and the Commission may also exchange such data with each other for the purpose of ensuring a uniform application of the customs legislation. Article 48 Post-release control For the purpose of customs controls, the customs authorities may verify the accuracy and completeness of the information given in a customs declaration, temporary storage declaration, entry summary declaration, exit summary declaration, re-export declaration or re-export notification, and the existence, authenticity, accuracy and validity of any supporting document and may examine the accounts of the declarant and other records relating to the operations in respect of the goods in question or to prior or subsequent commercial operations involving those goods after having released them. Those authorities may also examine such goods and/or take samples where it is still possible for them to do so. Such controls may be carried out at the premises of the holder of the goods or of the holder's representative, of any other person directly or indirectly involved in those operations in a business capacity or of any other person in possession of those documents and data for business purposes. Article 49 Intra-Union flights and sea crossings 1. Customs controls or formalities shall be carried out in respect of the cabin and hold baggage of persons either taking an intra-Union flight, or making an intra-Union sea crossing, only where the customs legislation provides for such controls or formalities. 2. Paragraph 1 shall apply without prejudice to either of the following: (a) security and safety checks; (b) checks linked to prohibitions or restrictions. Article 50 Conferral of implementing powers 1. The Commission shall adopt, by means of implementing acts, measures to ensure uniform application of the customs controls, including the exchange of risk information and risk analysis results, the common risk criteria and standards, the control measures and the priority control areas referred to in Article 46(3). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). On imperative grounds of urgency relating to such measures, duly justified by the need to rapidly update the common risk management framework and adapt the exchange of risk information and analysis, common risk criteria and standards, control measures and priority control areas to the evolution of risks, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 285(5). Where the opinion of the committee referred to in Article 285(1) is to be obtained by written procedure, Article 285(6) shall apply. 2. The Commission shall determine, by means of implementing acts, the ports or airports where, in accordance with Article 49, customs controls and formalities are applied to the following: (a) the cabin and hold baggage of persons: (i) taking a flight in an aircraft which comes from a non-Union airport and which, after a stopover at a Union airport, continues to another Union airport; (ii) taking a flight in an aircraft which stops over at a Union airport before continuing to a non-Union airport; (iii) using a maritime service provided by the same vessel and comprising successive legs departing from, calling at or terminating in a non-Union port; (iv) on board pleasure craft and tourist or business aircraft; (b) cabin and hold baggage: (i) arriving at a Union airport on board an aircraft coming from a non-Union airport and transferred at that Union airport to another aircraft proceeding on an intra-Union flight; (ii) loaded at a Union airport onto an aircraft proceeding on an intra-Union flight for transfer at another Union airport to an aircraft whose destination is a non-Union airport. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 8 Keeping of documents and other information, and charges and costs Article 51 Keeping of documents and other information 1. The person concerned shall, for the purposes of customs controls, keep the documents and information referred to in Article 15(1) for at least three years, by any means accessible by and acceptable to the customs authorities. In the case of goods released for free circulation in circumstances other than those referred to in the third subparagraph, or goods declared for export, that period shall run from the end of the year in which the customs declarations for release for free circulation or export are accepted. In the case of goods released for free circulation duty-free or at a reduced rate of import duty on account of their end-use, that period shall run from the end of the year in which they cease to be subject to customs supervision. In the case of goods placed under another customs procedure or of goods in temporary storage, that period shall run from the end of the year in which the customs procedure concerned has been discharged or temporary storage has ended. 2. Without prejudice to Article 103(4), where a customs control in respect of a customs debt shows that the relevant entry in the accounts has to be corrected and the person concerned has been notified of this, the documents and information shall be kept for three years beyond the time-limit provided for in paragraph 1 of this Article. Where an appeal has been lodged or where court proceedings have begun, the documents and information shall be kept for the period provided for in paragraph 1 or until the appeals procedure or court proceedings are terminated, whichever is the later. Article 52 Charges and costs 1. Customs authorities shall not impose charges for the performance of customs controls or any other application of the customs legislation during the official opening hours of their competent customs offices. 2. Customs authorities may impose charges or recover costs where specific services are rendered, in particular the following: (a) attendance, where requested, by customs staff outside official office hours or at premises other than customs premises; (b) analyses or expert reports on goods and postal fees for the return of goods to an applicant, particularly in respect of decisions taken pursuant to Article 33 or the provision of information in accordance with Article 14(1); (c) the examination or sampling of goods for verification purposes, or the destruction of goods, where costs other than the cost of using customs staff are involved; (d) exceptional control measures, where these are necessary due to the nature of the goods or to a potential risk. CHAPTER 3 Currency conversion and time-limits Article 53 Currency conversion 1. The competent authorities shall publish and/or make available on the Internet the rate of exchange applicable where the conversion of currency is necessary for one of the following reasons: (a) because factors used to determine the customs value of goods are expressed in a currency other than that of the Member State where the customs value is determined; (b) because the value of the euro is required in national currencies for the purposes of determining the tariff classification of goods and the amount of import and export duty, including value thresholds in the Common Customs Tariff. 2. Where the conversion of currency is necessary for reasons other than those referred to in paragraph 1, the value of the euro in national currencies to be applied within the framework of the customs legislation shall be fixed at least once a year. Article 54 Conferral of implementing powers The Commission shall lay down, by means of implementing acts, rules on currency conversions for the purposes referred to in Article 53(1) and (2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 55 Periods, dates and time-limits 1. Unless otherwise provided, where a period, date or time-limit is laid down in the customs legislation, such period shall not be extended or reduced and such date or time-limit shall not be deferred or brought forward. 2. The rules applicable to periods, dates and time-limits set out in Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time-limits (14) shall apply, except where otherwise provided for in the customs legislation. TITLE II FACTORS ON THE BASIS OF WHICH IMPORT OR EXPORT DUTY AND OTHER MEASURES IN RESPECT OF TRADE IN GOODS ARE APPLIED CHAPTER 1 Common Customs Tariff and tariff classification of goods Article 56 Common Customs Tariff and surveillance 1. Import and export duty due shall be based on the Common Customs Tariff. Other measures prescribed by Union provisions governing specific fields relating to trade in goods shall, where appropriate, be applied in accordance with the tariff classification of those goods. 2. The Common Customs Tariff shall comprise all of the following: (a) the Combined Nomenclature of goods as laid down in Regulation (EEC) No 2658/87; (b) any other nomenclature which is wholly or partly based on the Combined Nomenclature or which provides for further subdivisions to it, and which is established by Union provisions governing specific fields with a view to the application of tariff measures relating to trade in goods; (c) the conventional or normal autonomous customs duty applicable to goods covered by the Combined Nomenclature; (d) the preferential tariff measures contained in agreements which the Union has concluded with certain countries or territories outside the customs territory of the Union or groups of such countries or territories; (e) preferential tariff measures adopted unilaterally by the Union in respect of certain countries or territories outside the customs territory of the Union or groups of such countries or territories; (f) autonomous measures providing for a reduction in, or exemption from, customs duty on certain goods; (g) favourable tariff treatment specified for certain goods, by reason of their nature or end-use, in the framework of measures referred to under points (c) to (f) or (h); (h) other tariff measures provided for by agricultural or commercial or other Union legislation. 3. Where the goods concerned fulfil the conditions included in the measures laid down in points (d) to (g) of paragraph 2, the measures referred to in those provisions shall apply, upon application by the declarant, instead of those provided for in point (c) of that paragraph. Such application may be made retrospectively, provided that the time-limits and conditions laid down in the relevant measure or in the Code are complied with. 4. Where application of the measures referred to in points (d) to (g) of paragraph 2, or the exemption from measures referred to in point (h) thereof, is restricted to a certain volume of imports or exports, such application or exemption shall, in the case of tariff quotas, cease as soon as the specified volume of imports or exports is reached. In the case of tariff ceilings such application shall cease by virtue of a legal act of the Union. 5. The release for free circulation or the export of goods, to which the measures referred to in paragraphs 1 and 2 apply, may be made subject to surveillance. Article 57 Tariff classification of goods 1. For the application of the Common Customs Tariff, tariff classification of goods shall consist in the determination of one of the subheadings or further subdivisions of the Combined Nomenclature under which those goods are to be classified. 2. For the application of non-tariff measures, tariff classification of goods shall consist in the determination of one of the subheadings or further subdivisions of the Combined Nomenclature, or of any other nomenclature which is established by Union provisions and which is wholly or partly based on the Combined Nomenclature or which provides for further subdivisions to it, under which those goods are to be classified. 3. The subheading or further subdivision determined in accordance with paragraphs 1 and 2 shall be used for the purpose of applying the measures linked to that subheading. 4. The Commission may adopt measures to determine the tariff classification of goods in accordance with paragraphs 1 and 2. Article 58 Conferral of implementing powers 1. The Commission shall adopt, by means of implementing acts, measures on the uniform management of the tariff quotas and the tariff ceilings referred to in Article 56(4) and on the management of the surveillance of the release for free circulation or export of goods, referred to in Article 56(5). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). 2. The Commission shall adopt, by means of implementing acts, the measures referred to in Article 57(4). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). On imperative grounds of urgency relating to such measures, duly justified by the need to rapidly ensure the correct and uniform application of the Combined Nomenclature, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 285(5). Where the opinion of the committee referred to in Article 285(1) is to be obtained by written procedure, Article 285(6) shall apply. CHAPTER 2 Origin of goods Section 1 Non-preferential origin Article 59 Scope Articles 60 and 61 shall lay down rules for the determination of the non-preferential origin of goods for the purposes of applying the following: (a) the Common Customs Tariff, with the exception of the measures referred to in points (d) and (e) of Article 56(2); (b) measures, other than tariff measures, established by Union provisions governing specific fields relating to trade in goods; and (c) other Union measures relating to the origin of goods. Article 60 Acquisition of origin 1. Goods wholly obtained in a single country or territory shall be regarded as having their origin in that country or territory. 2. Goods the production of which involves more than one country or territory shall be deemed to originate in the country or territory where they underwent their last, substantial, economically-justified processing or working, in an undertaking equipped for that purpose, resulting in the manufacture of a new product or representing an important stage of manufacture. Article 61 Proof of origin 1. Where an origin has been indicated in the customs declaration pursuant to the customs legislation, the customs authorities may require the declarant to prove the origin of the goods. 2. Where proof of origin of goods is provided pursuant to the customs legislation or other Union legislation governing specific fields, the customs authorities may, in the event of reasonable doubt, require any additional evidence needed in order to ensure that the indication of origin complies with the rules laid down by the relevant Union legislation. 3. Where the exigencies of trade so require, a document proving origin may be issued in the Union in accordance with the rules of origin in force in the country or territory of destination or any other method identifying the country where the goods were wholly obtained or underwent their last substantial transformation. Article 62 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, laying down the rules under which goods, whose determination of non-preferential origin is required for the purposes of applying the Union measures referred to in Article 59, are considered as wholly obtained in a single country or territory or to have undergone their last, substantial, economically-justified processing or working, in an undertaking equipped for that purpose, resulting in the manufacture of a new product or representing an important stage of manufacture in a country or territory, in accordance with Article 60. Article 63 Conferral of implementing powers The Commission shall adopt, by means of implementing acts, the procedural rules for the provision and verification of the proof of origin referred to in Article 61. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Preferential origin Article 64 Preferential origin of goods 1. In order to benefit from the measures referred to in points (d) or (e) of Article 56(2) or from non-tariff preferential measures, goods shall comply with the rules on preferential origin referred to in paragraphs 2 to 5 of this Article. 2. In the case of goods benefiting from preferential measures contained in agreements which the Union has concluded with certain countries or territories outside the customs territory of the Union or with groups of such countries or territories, the rules on preferential origin shall be laid down in those agreements. 3. In the case of goods benefiting from preferential measures adopted unilaterally by the Union in respect of certain countries or territories outside the customs territory of the Union or groups of such countries or territories, other than those referred to in paragraph 5, the Commission shall adopt measures laying down the rules on preferential origin. Those rules shall be based either on the criterion that goods are wholly obtained or on the criterion that goods result from sufficient processing or working. 4. In the case of goods benefiting from preferential measures applicable in trade between the customs territory of the Union and Ceuta and Melilla, as contained in Protocol 2 to the 1985 Act of Accession, the rules on preferential origin shall be adopted in accordance with Article 9 of that Protocol. 5. In the case of goods benefiting from preferential measures contained in preferential arrangements in favour of the overseas countries and territories associated with the Union, the rules on preferential origin shall be adopted in accordance with Article 203 TFEU. 6. Upon its own initiative or at the request of a beneficiary country or territory, the Commission may, for certain goods, grant that country or territory a temporary derogation from the rules on preferential origin referred to in paragraph 3. The temporary derogation shall be justified by one of the following reasons: (a) internal or external factors temporarily deprive the beneficiary country or territory of the ability to comply with the rules on preferential origin; (b) the beneficiary country or territory requires time to prepare itself to comply with those rules. A request for derogation shall be made in writing to the Commission by the beneficiary country or territory concerned. The request shall state the reasons, as indicated in the second subparagraph, why derogation is required and shall contain appropriate supporting documents. The temporary derogation shall be limited to the duration of the effects of the internal or external factors giving rise to it or the length of time needed for the beneficiary country or territory to achieve compliance with the rules. Where a derogation is granted, the beneficiary country or territory concerned shall comply with any requirements laid down as to information to be provided to the Commission concerning the use of the derogation and the management of the quantities for which the derogation is granted. Article 65 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, laying down the rules on preferential origin referred to in Article 64(3). Article 66 Conferral of implementing powers The Commission shall adopt by means of implementing acts: (a) the procedural rules, referred to in Article 64(1), to facilitate the establishment in the Union of the preferential origin of goods; (b) a measure granting a beneficiary country or territory the temporary derogation referred to in Article 64(6). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 3 Determination of origin of specific goods Article 67 Measures taken by the Commission The Commission may adopt measures to determine the origin of specific goods in accordance with the rules of origin applicable to those goods. Article 68 Conferral of implementing powers The Commission shall adopt, by means of implementing acts, the measures referred to in Article 67. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). On imperative grounds of urgency relating to such measures, duly justified by the need to rapidly ensure the correct and uniform application of rules of origin, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 285(5). Where the opinion of the committee referred to in Article 285(1) is to be obtained by written procedure, Article 285(6) shall apply. CHAPTER 3 Value of goods for customs purposes Article 69 Scope The customs value of goods, for the purposes of applying the Common Customs Tariff and non-tariff measures laid down by Union provisions governing specific fields relating to trade in goods, shall be determined in accordance with Articles 70 and 74. Article 70 Method of customs valuation based on the transaction value 1. The primary basis for the customs value of goods shall be the transaction value, that is the price actually paid or payable for the goods when sold for export to the customs territory of the Union, adjusted, where necessary. 2. The price actually paid or payable shall be the total payment made or to be made by the buyer to the seller or by the buyer to a third party for the benefit of the seller for the imported goods and include all payments made or to be made as a condition of sale of the imported goods. 3. The transaction value shall apply provided that all of the following conditions are fulfilled: (a) there are no restrictions as to the disposal or use of the goods by the buyer, other than any of the following: (i) restrictions imposed or required by a law or by the public authorities in the Union; (ii) limitations of the geographical area in which the goods may be resold; (iii) restrictions which do not substantially affect the customs value of the goods; (b) the sale or price is not subject to some condition or consideration for which a value cannot be determined with respect to the goods being valued; (c) no part of the proceeds of any subsequent resale, disposal or use of the goods by the buyer will accrue directly or indirectly to the seller, unless an appropriate adjustment can be made; (d) the buyer and seller are not related or the relationship did not influence the price. Article 71 Elements of the transaction value 1. In determining the customs value under Article 70, the price actually paid or payable for the imported goods shall be supplemented by: (a) the following, to the extent that they are incurred by the buyer but are not included in the price actually paid or payable for the goods: (i) commissions and brokerage, except buying commissions; (ii) the cost of containers which are treated as being one, for customs purposes, with the goods in question; and (iii) the cost of packing, whether for labour or materials; (b) the value, apportioned as appropriate, of the following goods and services where supplied directly or indirectly by the buyer free of charge or at reduced cost for use in connection with the production and sale for export of the imported goods, to the extent that such value has not been included in the price actually paid or payable: (i) materials, components, parts and similar items incorporated into the imported goods; (ii) tools, dies, moulds and similar items used in the production of the imported goods; (iii) materials consumed in the production of the imported goods; and (iv) engineering, development, artwork, design work, and plans and sketches undertaken elsewhere than in the Union and necessary for the production of the imported goods; (c) royalties and licence fees related to the goods being valued that the buyer must pay, either directly or indirectly, as a condition of sale of the goods being valued, to the extent that such royalties and fees are not included in the price actually paid or payable; (d) the value of any part of the proceeds of any subsequent resale, disposal or use of the imported goods that accrues directly or indirectly to the seller; and (e) the following costs up to the place where goods are brought into the customs territory of the Union: (i) the cost of transport and insurance of the imported goods; and (ii) loading and handling charges associated with the transport of the imported goods. 2. Additions to the price actually paid or payable, pursuant to paragraph 1, shall be made only on the basis of objective and quantifiable data. 3. No additions shall be made to the price actually paid or payable in determining the customs value except as provided in this Article. Article 72 Elements not to be included in the customs value In determining the customs value under Article 70, none of the following shall be included: (a) the cost of transport of the imported goods after their entry into the customs territory of the Union; (b) charges for construction, erection, assembly, maintenance or technical assistance, undertaken after the entry into the customs territory of the Union of the imported goods such as industrial plants, machinery or equipment; (c) charges for interest under a financing arrangement entered into by the buyer and relating to the purchase of the imported goods, irrespective of whether the finance is provided by the seller or another person, provided that the financing arrangement has been made in writing and, where required, the buyer can demonstrate that the following conditions are fulfilled: (i) such goods are actually sold at the price declared as the price actually paid or payable; (ii) the claimed rate of interest does not exceed the level for such transactions prevailing in the country where, and at the time when, the finance was provided; (d) charges for the right to reproduce the imported goods in the Union; (e) buying commissions; (f) import duties or other charges payable in the Union by reason of the import or sale of the goods; (g) notwithstanding point (c) of Article 71(1), payments made by the buyer for the right to distribute or resell the imported goods, if such payments are not a condition of the sale for export to the Union of the goods. Article 73 Simplification The customs authorities may, upon application, authorise that the following amounts be determined on the basis of specific criteria, where they are not quantifiable on the date on which the customs declaration is accepted: (a) amounts which are to be included in the customs value in accordance with Article 70(2); and (b) the amounts referred to in Articles 71 and 72. Article 74 Secondary methods of customs valuation 1. Where the customs value of goods cannot be determined under Article 70, it shall be determined by proceeding sequentially from points (a) to (d) of paragraph 2, until the first point under which the customs value of goods can be determined. The order of application of points (c) and (d) of paragraph 2 shall be reversed if the declarant so requests. 2. The customs value, pursuant to paragraph 1, shall be: (a) the transaction value of identical goods sold for export to the customs territory of the Union and exported at or about the same time as the goods being valued; (b) the transaction value of similar goods sold for export to the customs territory of the Union and exported at or about the same time as the goods being valued; (c) the value based on the unit price at which the imported goods, or identical or similar imported goods, are sold within the customs territory of the Union in the greatest aggregate quantity to persons not related to the sellers; or (d) the computed value, consisting of the sum of: (i) the cost or value of materials and fabrication or other processing employed in producing the imported goods; (ii) an amount for profit and general expenses equal to that usually reflected in sales of goods of the same class or kind as the goods being valued which are made by producers in the country of export for export to the Union; (iii) the cost or value of the elements referred to in point (e) of Article 71(1). 3. Where the customs value cannot be determined under paragraph 1, it shall be determined on the basis of data available in the customs territory of the Union, using reasonable means consistent with the principles and general provisions of all of the following: (a) the agreement on implementation of Article VII of the General Agreement on Tariffs and Trade; (b) Article VII of the General Agreement on Tariffs and Trade; (c) this Chapter. Article 75 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the conditions for granting the authorisation referred to in Article 73. Article 76 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) determining the customs value in accordance with Articles 70(1) and (2) and Articles 71 and 72, including those for adjusting the price actually paid or payable; (b) the application of the conditions referred to in Article 70(3); (c) determining the customs value referred to in Article 74. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). TITLE III CUSTOMS DEBT AND GUARANTEES CHAPTER 1 Incurrence of a customs debt Section 1 Customs debt on import Article 77 Release for free circulation and temporary admission 1. A customs debt on import shall be incurred through the placing of non-Union goods liable to import duty under either of the following customs procedures: (a) release for free circulation, including under the end-use provisions; (b) temporary admission with partial relief from import duty. 2. A customs debt shall be incurred at the time of acceptance of the customs declaration. 3. The declarant shall be the debtor. In the event of indirect representation, the person on whose behalf the customs declaration is made shall also be a debtor. Where a customs declaration in respect of one of the procedures referred to in paragraph 1 is drawn up on the basis of information which leads to all or part of the import duty not being collected, the person who provided the information required to draw up the declaration and who knew, or who ought reasonably to have known, that such information was false shall also be a debtor. Article 78 Special provisions relating to non-originating goods 1. Where a prohibition of drawback of, or exemption from, import duty applies to non-originating goods used in the manufacture of products for which a proof of origin is issued or made out in the framework of a preferential arrangement between the Union and certain countries or territories outside the customs territory of the Union or groups of such countries or territories, a customs debt on import shall be incurred in respect of those non-originating goods, through the acceptance of the re-export declaration relating to the products in question. 2. Where a customs debt is incurred pursuant to paragraph 1, the amount of import duty corresponding to that debt shall be determined under the same conditions as in the case of a customs debt resulting from the acceptance, on the same date, of the customs declaration for release for free circulation of the non-originating goods used in the manufacture of the products in question for the purpose of ending the inward processing procedure. 3. Article 77(2) and (3) shall apply. However, in the case of non-Union goods as referred to in Article 270 the person who lodges the re-export declaration shall be the debtor. In the event of indirect representation, the person on whose behalf the declaration is lodged shall also be a debtor. Article 79 Customs debt incurred through non-compliance 1. For goods liable to import duty, a customs debt on import shall be incurred through non-compliance with any of the following: (a) one of the obligations laid down in the customs legislation concerning the introduction of non-Union goods into the customs territory of the Union, their removal from customs supervision, or the movement, processing, storage, temporary storage, temporary admission or disposal of such goods within that territory; (b) one of the obligations laid down in the customs legislation concerning the end-use of goods within the customs territory of the Union; (c) a condition governing the placing of non-Union goods under a customs procedure or the granting, by virtue of the end-use of the goods, of duty exemption or a reduced rate of import duty. 2. The time at which the customs debt is incurred shall be either of the following: (a) the moment when the obligation the non-fulfilment of which gives rise to the customs debt is not met or ceases to be met; (b) the moment when a customs declaration is accepted for the placing of goods under a customs procedure where it is established subsequently that a condition governing the placing of the goods under that procedure or the granting of a duty exemption or a reduced rate of import duty by virtue of the end-use of the goods was not in fact fulfilled. 3. In cases referred to under points (a) and (b) of paragraph 1, the debtor shall be any of the following: (a) any person who was required to fulfil the obligations concerned; (b) any person who was aware or should reasonably have been aware that an obligation under the customs legislation was not fulfilled and who acted on behalf of the person who was obliged to fulfil the obligation, or who participated in the act which led to the non-fulfilment of the obligation; (c) any person who acquired or held the goods in question and who was aware or should reasonably have been aware at the time of acquiring or receiving the goods that an obligation under the customs legislation was not fulfilled. 4. In cases referred to under point (c) of paragraph 1, the debtor shall be the person who is required to comply with the conditions governing the placing of the goods under a customs procedure or the customs declaration of the goods placed under that customs procedure or the granting of a duty exemption or reduced rate of import duty by virtue of the end-use of the goods. Where a customs declaration in respect of one of the customs procedures referred to in point (c) of paragraph 1 is drawn up, and any information required under the customs legislation relating to the conditions governing the placing of the goods under that customs procedure is given to the customs authorities, which leads to all or part of the import duty not being collected, the person who provided the information required to draw up the customs declaration and who knew, or who ought reasonably to have known, that such information was false shall also be a debtor. Article 80 Deduction of an amount of import duty already paid 1. Where a customs debt is incurred, pursuant to Article 79(1) in respect of goods released for free circulation at a reduced rate of import duty on account of their end-use, the amount of import duty paid when the goods were released for free circulation shall be deducted from the amount of import duty corresponding to the customs debt. The first subparagraph shall apply where a customs debt is incurred in respect of scrap and waste resulting from the destruction of such goods. 2. Where a customs debt is incurred, pursuant to Article 79(1) in respect of goods placed under temporary admission with partial relief from import duty, the amount of import duty paid under partial relief shall be deducted from the amount of import duty corresponding to the customs debt. Section 2 Customs debt on export Article 81 Export and outward processing 1. A customs debt on export shall be incurred through the placing of goods liable to export duty under the export procedure or the outward processing procedure. 2. The customs debt shall be incurred at the time of acceptance of the customs declaration. 3. The declarant shall be the debtor. In the event of indirect representation, the person on whose behalf the customs declaration is made shall also be a debtor. Where a customs declaration is drawn up on the basis of information which leads to all or part of the export duty not being collected, the person who provided the information required for the declaration and who knew, or who should reasonably have known, that such information was false shall also be a debtor. Article 82 Customs debt incurred through non-compliance 1. For goods liable to export duty, a customs debt on export shall be incurred through non-compliance with either of the following: (a) one of the obligations laid down in the customs legislation for the exit of the goods; (b) the conditions under which the goods were allowed to be taken out of the customs territory of the Union with total or partial relief from export duty. 2. The time at which the customs debt is incurred shall be one of the following: (a) the moment at which the goods are actually taken out of the customs territory of the Union without a customs declaration; (b) the moment at which the goods reach a destination other than that for which they were allowed to be taken out of the customs territory of the Union with total or partial relief from export duty; (c) should the customs authorities be unable to determine the moment referred to in point (b), the expiry of the time-limit set for the production of evidence that the conditions entitling the goods to such relief have been fulfilled. 3. In cases referred to under point (a) of paragraph 1, the debtor shall be any of the following: (a) any person who was required to fulfil the obligation concerned; (b) any person who was aware or should reasonably have been aware that the obligation concerned was not fulfilled and who acted on behalf of the person who was obliged to fulfil the obligation; (c) any person who participated in the act which led to the non-fulfilment of the obligation and who was aware or should reasonably have been aware that a customs declaration had not been lodged but should have been. 4. In cases referred to under point (b) of paragraph 1, the debtor shall be any person who is required to comply with the conditions under which the goods were allowed to be taken out of the customs territory of the Union with total or partial relief from export duty. Section 3 Provisions common to customs debts incurred on import and export Article 83 Prohibitions and restrictions 1. The customs debt on import or export shall be incurred even if it relates to goods which are subject to measures of prohibition or restriction on import or export of any kind. 2. However, no customs debt shall be incurred on either of the following: (a) the unlawful introduction into the customs territory of the Union of counterfeit currency; (b) the introduction into the customs territory of the Union of narcotic drugs and psychotropic substances other than where strictly supervised by the competent authorities with a view to their use for medical and scientific purposes. 3. For the purposes of penalties as applicable to customs offences, the customs debt shall nevertheless be deemed to have been incurred where, under the law of a Member State, import or export duty or the existence of a customs debt provide the basis for determining penalties. Article 84 Several debtors Where several persons are liable for payment of the amount of import or export duty corresponding to one customs debt, they shall be jointly and severally liable for payment of that amount. Article 85 General rules for calculating the amount of import or export duty 1. The amount of import or export duty shall be determined on the basis of those rules for calculation of duty which were applicable to the goods concerned at the time at which the customs debt in respect of them was incurred. 2. Where it is not possible to determine precisely the time at which the customs debt is incurred, that time shall be deemed to be the time at which the customs authorities conclude that the goods are in a situation in which a customs debt has been incurred. However, where the information available to the customs authorities enables them to establish that the customs debt had been incurred prior to the time at which they reached that conclusion, the customs debt shall be deemed to have been incurred at the earliest time that such a situation can be established. Article 86 Special rules for calculating the amount of import duty 1. Where costs for storage or usual forms of handling have been incurred within the customs territory of the Union in respect of goods placed under a customs procedure or in temporary storage, such costs or the increase in value shall not be taken into account for the calculation of the amount of import duty where satisfactory proof of those costs is provided by the declarant. However, the customs value, quantity, nature and origin of non-Union goods used in the operations shall be taken into account for the calculation of the amount of import duty. 2. Where the tariff classification of goods placed under a customs procedure changes as a result of usual forms of handling within the customs territory of the Union, the original tariff classification for the goods placed under the procedure shall be applied at the request of the declarant. 3. Where a customs debt is incurred for processed products resulting from the inward processing procedure, the amount of import duty corresponding to such debt shall, at the request of the declarant, be determined on the basis of the tariff classification, customs value, quantity, nature and origin of the goods placed under the inward processing procedure at the time of acceptance of the customs declaration relating to those goods. 4. In specific cases, the amount of import duty shall be determined in accordance with paragraphs 2 and 3 of this Article without a request of the declarant in order to avoid the circumvention of tariff measures referred to in point (h) of Article 56(2). 5. Where a customs debt is incurred for processed products resulting from the outward processing procedure or replacement products as referred to in Article 261(1), the amount of import duty shall be calculated on the basis of the cost of the processing operation undertaken outside the customs territory of the Union. 6. Where the customs legislation provides for a favourable tariff treatment of goods, or for relief or total or partial exemption from import or export duty pursuant to points (d) to (g) of Article 56(2), Articles 203, 204, 205 and 208 or Articles 259 to 262 of this Regulation or pursuant to Council Regulation (EC) No 1186/2009 of 16 November 2009 setting up a Community system of reliefs from customs duty (15) such favourable tariff treatment, relief or exemption shall also apply in cases where a customs debt is incurred pursuant to Articles 79 or 82 of this Regulation, on condition that the failure which led to the incurrence of a customs debt did not constitute an attempt at deception. Article 87 Place where the customs debt is incurred 1. A customs debt shall be incurred at the place where the customs declaration or the re-export declaration referred to in Articles 77, 78 and 81 is lodged. In all other cases, the place where a customs debt is incurred shall be the place where the events from which it arises occur. If it is not possible to determine that place, the customs debt shall be incurred at the place where the customs authorities conclude that the goods are in a situation in which a customs debt is incurred. 2. If the goods have been placed under a customs procedure which has not been discharged or when a temporary storage did not end properly, and the place where the customs debt is incurred cannot be determined pursuant to the second or third subparagraphs of paragraph 1 within a specific time-limit, the customs debt shall be incurred at the place where the goods were either placed under the procedure concerned or were introduced into the customs territory of the Union under that procedure or were in temporary storage. 3. Where the information available to the customs authorities enables them to establish that the customs debt may have been incurred in several places, the customs debt shall be deemed to have been incurred at the place where it was first incurred. 4. If a customs authority establishes that a customs debt has been incurred under Article 79 or Article 82 in another Member State and the amount of import or export duty corresponding to that debt is lower than EUR 10 000, the customs debt shall be deemed to have been incurred in the Member State where the finding was made. Article 88 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the rules for the calculation of the amount of import or export duty applicable to goods for which a customs debt is incurred in the context of a special procedure, which supplement the rules laid down in Articles 85 and 86; (b) the cases referred to in Article 86(4); (c) the time-limit referred to in Article 87(2). CHAPTER 2 Guarantee for a potential or existing customs debt Article 89 General provisions 1. This Chapter shall apply to guarantees both for customs debts which have been incurred and for those which may be incurred, unless otherwise specified. 2. Where the customs authorities require a guarantee for a potential or existing customs debt to be provided, that guarantee shall cover the amount of import or export duty and the other charges due in connection with the import or export of the goods where: (a) the guarantee is used for the placing of goods under the Union transit procedure; or (b) the guarantee may be used in more than one Member State. A guarantee which may not be used outside the Member State where it is required shall be valid only in that Member State and shall cover at least the amount of import or export duty. 3. Where the customs authorities require a guarantee to be provided, it shall be required from the debtor or the person who may become the debtor. They may also permit the guarantee to be provided by a person other than the person from whom it is required. 4. Without prejudice to Article 97, the customs authorities shall require only one guarantee to be provided in respect of specific goods or a specific declaration. The guarantee provided for a specific declaration shall apply to the amount of import or export duty corresponding to the customs debt and other charges in respect of all goods covered by or released against that declaration, whether or not that declaration is correct. If the guarantee has not been released, it may also be used, within the limits of the secured amount, for the recovery of amounts of import or export duty and other charges payable following post-release control of those goods. 5. Upon application by the person referred to in paragraph 3 of this Article, the customs authorities may, in accordance with Article 95(1), (2) and (3), authorise the provision of a comprehensive guarantee to cover the amount of import or export duty corresponding to the customs debt in respect of two or more operations, declarations or customs procedures. 6. The customs authorities shall monitor the guarantee. 7. No guarantee shall be required from States, regional and local government authorities or other bodies governed by public law, in respect of the activities in which they engage as public authorities. 8. No guarantee shall be required in any of the following situations: (a) goods carried on the Rhine, the Rhine waterways, the Danube or the Danube waterways; (b) goods carried by a fixed transport installation; (c) in specific cases where goods are placed under the temporary admission procedure; (d) goods placed under the Union transit procedure using the simplification referred to in point (e) of Article 233(4) and carried by sea or air between Union ports or between Union airports. 9. The customs authorities may waive the requirement for provision of a guarantee where the amount of import or export duty to be secured does not exceed the statistical value threshold for declarations laid down in Article 3(4) of Regulation (EC) No 471/2009 of the European Parliament and of the Council of 6 May 2009 on Community statistics relating to external trade with non-member countries (16). Article 90 Compulsory guarantee 1. Where it is compulsory for a guarantee to be provided, the customs authorities shall fix the amount of such guarantee at a level equal to the precise amount of import or export duty corresponding to the customs debt and of other charges where that amount can be established with certainty at the time when the guarantee is required. Where it is not possible to establish the precise amount, the guarantee shall be fixed at the maximum amount, as estimated by the customs authorities, of import or export duty corresponding to the customs debt and of other charges which have been or may be incurred. 2. Without prejudice to Article 95 where a comprehensive guarantee is provided for the amount of import or export duty corresponding to customs debts and other charges which vary in amount over time, the amount of such guarantee shall be set at a level enabling the amount of import or export duty corresponding to customs debts and other charges to be covered at all times. Article 91 Optional guarantee Where the provision of a guarantee is optional, such guarantee shall in any case be required by the customs authorities if they consider that the amount of import or export duty corresponding to a customs debt and other charges are not certain to be paid within the prescribed period. Its amount shall be fixed by those authorities so as not to exceed the level referred to in Article 90. Article 92 Provision of a guarantee 1. A guarantee may be provided in one of the following forms: (a) by a cash deposit or by any other means of payment recognised by the customs authorities as being equivalent to a cash deposit, made in euro or in the currency of the Member State in which the guarantee is required; (b) by an undertaking given by a guarantor; (c) by another form of guarantee which provides equivalent assurance that the amount of import or export duty corresponding to the customs debt and other charges will be paid. 2. A guarantee in the form of a cash deposit or any other equivalent means of payment shall be given in accordance with the provisions in force in the Member State in which the guarantee is required. Where a guarantee is given by making a cash deposit or any other equivalent means of payment, no interest thereon shall be payable by the customs authorities. Article 93 Choice of guarantee The person required to provide a guarantee may choose between the forms of guarantee laid down in Article 92(1). However, the customs authorities may refuse to accept the form of guarantee chosen where it is incompatible with the proper functioning of the customs procedure concerned. The customs authorities may require that the form of guarantee chosen be maintained for a specific period. Article 94 Guarantor 1. The guarantor referred to in point (b) of Article 92(1) shall be a third person established in the customs territory of the Union. The guarantor shall be approved by the customs authorities requiring the guarantee, unless the guarantor is a credit institution, financial institution or insurance company accredited in the Union in accordance with Union provisions in force. 2. The guarantor shall undertake in writing to pay the secured amount of import or export duty corresponding to a customs debt and other charges. 3. The customs authorities may refuse to approve the guarantor or the type of guarantee proposed where either does not appear certain to ensure payment within the prescribed period of the amount of import or export duty corresponding to the customs debt and of other charges. Article 95 Comprehensive guarantee 1. The authorisation referred to in Article 89(5) shall be granted only to persons who satisfy all of the following conditions: (a) they are established in the customs territory of the Union; (b) they fulfil the criteria laid down in point (a) of Article 39; (c) they are regular users of the customs procedures involved or operators of temporary storage facilities or they fulfil the criteria laid down in point (d) of Article 39. 2. Where a comprehensive guarantee is to be provided for customs debts and other charges which may be incurred, an economic operator may be authorised to use a comprehensive guarantee with a reduced amount or to have a guarantee waiver, provided that he or she fulfils the criteria laid down in points (b) and (c) of Article 39. 3. Where a comprehensive guarantee is to be provided for customs debts and other charges which have been incurred, an authorised economic operator for customs simplification shall, upon application, be authorised to use a comprehensive guarantee with a reduced amount. 4. The comprehensive guarantee with a reduced amount referred to in paragraph 3 shall be equivalent to the provision of a guarantee. Article 96 Temporary prohibitions relating to the use of comprehensive guarantees 1. In the context of special procedures or temporary storage, the Commission may decide to temporarily prohibit recourse to any of the following: (a) the comprehensive guarantee for a reduced amount or a guarantee waiver referred to in Article 95(2); (b) the comprehensive guarantee referred to in Article 95, in respect of goods which have been identified as being subject to large-scale fraud. 2. Where point (a) or point (b) of paragraph 1 of this Article applies, recourse to the comprehensive guarantee for a reduced amount or a guarantee waiver or recourse to the comprehensive guarantee referred to in Article 95 may be authorised where the person concerned fulfils either of the following conditions: (a) that person can show that no customs debt has arisen in respect of the goods in question in the course of operations which that person has undertaken in the two years preceding the decision referred to in paragraph 1; (b) where customs debts have arisen in the two years preceding the decision referred to in paragraph 1, the person concerned can show that those debts were fully paid by the debtor or debtors or the guarantor within the prescribed time-limit. To obtain authorisation to use a temporarily prohibited comprehensive guarantee, the person concerned must also fulfil the criteria laid down in points (b) and (c) of Article 39. Article 97 Additional or replacement guarantee Where the customs authorities establish that the guarantee provided does not ensure, or is no longer certain or sufficient to ensure, payment within the prescribed period of the amount of import or export duty corresponding to the customs debt and other charges, they shall require any of the persons referred to in Article 89(3) either to provide an additional guarantee or to replace the original guarantee with a new guarantee, according to his choice. Article 98 Release of the guarantee 1. The customs authorities shall release the guarantee immediately when the customs debt or liability for other charges is extinguished or can no longer arise. 2. Where the customs debt or liability for other charges has been extinguished in part, or may arise only in respect of part of the amount which has been secured, a corresponding part of the guarantee shall be released accordingly at the request of the person concerned, unless the amount involved does not justify such action. Article 99 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the specific cases, referred to in point (c) of Article 89(8), where no guarantee is required for goods placed under the temporary admission procedure; (b) the form of the guarantee, referred to in point (c) of Article 92(1), and the rules concerning the guarantor referred to in Article 94; (c) the conditions for the granting of an authorisation to use a comprehensive guarantee with a reduced amount or to have a guarantee waiver referred to in Article 95(2); (d) time-limits for the release of a guarantee. Article 100 Conferral of implementing powers 1. The Commission shall specify, by means of implementing acts, the procedural rules: (a) for determining the amount of the guarantee, including the reduced amount referred to in Article 95(2) and (3); (b) regarding the provision and the monitoring of the guarantee referred to in Article 89, the revocation and cancellation of the undertaking given by the guarantor referred to in Article 94, and the release of the guarantee referred to in Article 98; (c) regarding the temporary prohibitions referred to in Article 96. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). 2. The Commission shall adopt the measures referred to in Article 96 by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). On imperative grounds of urgency relating to such measures, duly justified by the need to rapidly enhance the protection of the financial interests of the Union and of its Member States, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 285(5). Where the opinion of the committee referred to in Article 285(1) is to be obtained by written procedure, Article 285(6) shall apply. CHAPTER 3 Recovery, payment, repayment and remission of the amount of import or export duty Section 1 Determination of the amount of import or export duty, notification of the customs debt and entry in the accounts Article 101 Determination of the amount of import or export duty 1. The amount of import or export duty payable shall be determined by the customs authorities responsible for the place where the customs debt is incurred, or is deemed to have been incurred in accordance with Article 87, as soon as they have the necessary information. 2. Without prejudice to Article 48, the customs authorities may accept the amount of import or export duty payable determined by the declarant. 3. Where the amount of import or export duty payable does not result in a whole number, that amount may be rounded. Where the amount referred in the first subparagraph is expressed in euros, rounding may not be more than a rounding up or down to the nearest whole number. A Member State whose currency is not the euro may either apply mutatis mutandis the provisions of the second subparagraph or derogate from that subparagraph, provided that the rules applicable on rounding do not have a greater financial impact than the rule set out in the second subparagraph. Article 102 Notification of the customs debt 1. The customs debt shall be notified to the debtor in the form prescribed at the place where the customs debt is incurred, or is deemed to have been incurred in accordance with Article 87. The notification referred to in the first subparagraph shall not be made in any of the following cases: (a) where, pending a final determination of the amount of import or export duty, a provisional commercial policy measure taking the form of a duty has been imposed; (b) where the amount of import or export duty payable exceeds that determined on the basis of a decision made in accordance with Article 33; (c) where the original decision not to notify the customs debt or to notify it with an amount of import or export duty at a figure less than the amount of import or export duty payable was taken on the basis of general provisions invalidated at a later date by a court decision; (d) where the customs authorities are exempted under the customs legislation from notification of the customs debt. 2. Where the amount of import or export duty payable is equal to the amount entered in the customs declaration, release of the goods by the customs authorities shall be equivalent to notifying the debtor of the customs debt. 3. Where paragraph 2 does not apply, the customs debt shall be notified to the debtor by the customs authorities when they are in a position to determine the amount of import or export duty payable and take a decision thereon. However, where the notification of the customs debt would prejudice a criminal investigation, the customs authorities may defer that notification until such time as it no longer prejudices the criminal investigation. 4. Provided that payment has been guaranteed, the customs debt corresponding to the total amount of import or export duty relating to all the goods released to one and the same person during a period fixed by the customs authorities may be notified at the end of that period. The period fixed by the customs authorities shall not exceed 31 days. Article 103 Limitation of the customs debt 1. No customs debt shall be notified to the debtor after the expiry of a period of three years from the date on which the customs debt was incurred. 2. Where the customs debt is incurred as the result of an act which, at the time it was committed, was liable to give rise to criminal court proceedings, the three-year period laid down in paragraph 1 shall be extended to a period of a minimum of five years and a maximum of 10 years in accordance with national law. 3. The periods laid down in paragraphs 1 and 2 shall be suspended where: (a) an appeal is lodged in accordance with Article 44; such suspension shall apply from the date on which the appeal is lodged and shall last for the duration of the appeal proceedings; or (b) the customs authorities communicate to the debtor, in accordance with Article 22(6), the grounds on which they intend to notify the customs debt; such suspension shall apply from the date of that communication until the end of the period within which the debtor is given the opportunity to express his or her point of view. 4. Where a customs debt is reinstated pursuant to Article 116(7), the periods laid down in paragraphs 1 and 2 shall be considered as suspended from the date on which the application for repayment or remission was submitted in accordance with Article 121, until the date on which the decision on the repayment or remission was taken. Article 104 Entry in the accounts 1. The customs authorities referred to in Article 101 shall enter in their accounts, in accordance with the national legislation, the amount of import or export duty payable as determined in accordance with that Article. The first subparagraph shall not apply in cases referred to in the second subparagraph of Article 102(1). 2. The customs authorities need not enter in the accounts amounts of import or export duty which, pursuant to Article 103, correspond to a customs debt which could no longer be notified to the debtor. 3. Member States shall determine the practical procedures for the entry in the accounts of the amounts of import or export duty. Those procedures may differ according to whether, in view of the circumstances in which the customs debt was incurred, the customs authorities are satisfied that those amounts will be paid. Article 105 Time of entry in the accounts 1. Where a customs debt is incurred as a result of the acceptance of the customs declaration of goods for a customs procedure, other than temporary admission with partial relief from import duty, or of any other act having the same legal effect as such acceptance, the customs authorities shall enter the amount of import or export duty payable in the accounts within 14 days of the release of the goods. However, provided that payment has been guaranteed, the total amount of import or export duty relating to all the goods released to one and the same person during a period fixed by the customs authorities, which may not exceed 31 days, may be covered by a single entry in the accounts at the end of that period. Such entry in the accounts shall take place within 14 days of the expiry of the period concerned. 2. Where goods may be released subject to certain conditions which govern either the determination of the amount of import or export duty payable or its collection, entry in the accounts shall take place within 14 days of the day on which the amount of import or export duty payable is determined or the obligation to pay that duty is fixed. However, where the customs debt relates to a provisional commercial policy measure taking the form of a duty, the amount of import or export duty payable shall be entered in the accounts within two months of the date of publication in the Official Journal of the European Union of the Regulation establishing the definitive commercial policy measure. 3. Where a customs debt is incurred in circumstances not covered by paragraph 1, the amount of import or export duty payable shall be entered in the accounts within 14 days of the date on which the customs authorities are in a position to determine the amount of import or export duty in question and take a decision. 4. Paragraph 3 shall apply with regard to the amount of import or export duty to be recovered or which remains to be recovered where the amount of import or export duty payable has not been entered in the accounts in accordance with paragraphs 1, 2 and 3, or has been determined and entered in the accounts at a level lower than the amount payable. 5. The time-limits for entry in the accounts laid down in paragraphs 1, 2 and 3 shall not apply in unforeseeable circumstances or in cases of force majeure. 6. The entry in the accounts may be deferred in the case referred to in the second subparagraph of Article 102(3), until such time as the notification of the customs debt no longer prejudices a criminal investigation. Article 106 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the cases referred to in point (d) of Article 102(1) where the customs authorities are exempted from notification of the customs debt. Article 107 Conferral of implementing powers The Commission shall adopt, by means of implementing acts, measures to ensure mutual assistance between the customs authorities in case of incurrence of a customs debt. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Payment of the amount of import or export duty Article 108 General time-limits for payment and suspension of the time-limit for payment 1. Amounts of import or export duty, corresponding to a customs debt notified in accordance with Article 102, shall be paid by the debtor within the period prescribed by the customs authorities. Without prejudice to Article 45(2), that period shall not exceed 10 days following notification to the debtor of the customs debt. In the case of aggregation of entries in the accounts under the conditions laid down in the second subparagraph of Article 105(1), it shall be so fixed as not to enable the debtor to obtain a longer period for payment than if he or she had been granted deferred payment in accordance with Article 110. The customs authorities may extend that period upon application by the debtor where the amount of import or export duty payable has been determined in the course of post-release control as referred to in Article 48. Without prejudice to Article 112(1), such extensions shall not exceed the time necessary for the debtor to take the appropriate steps to discharge his or her obligation. 2. If the debtor is entitled to any of the payment facilities laid down in Articles 110 to 112, payment shall be made within the period or periods specified in relation to those facilities. 3. The time-limit for payment of the amount of import or export duty corresponding to a customs debt shall be suspended in any of the following cases: (a) where an application for remission of duty is made in accordance with Article 121; (b) where goods are to be confiscated, destroyed or abandoned to the State; (c) where the customs debt was incurred pursuant to Article 79 and there is more than one debtor. Article 109 Payment 1. Payment shall be made in cash or by any other means with similar discharging effect, including by adjustment of a credit balance, in accordance with national legislation. 2. Payment may be made by a third person instead of the debtor. 3. The debtor may in any case pay all or part of the amount of import or export duty without awaiting expiry of the period he or she has been granted for payment. Article 110 Deferment of payment The customs authorities shall, upon application by the person concerned and upon provision of a guarantee, authorise deferment of payment of the duty payable in any of the following ways: (a) separately in respect of each amount of import or export duty entered in the accounts in accordance with the first subparagraph of Article 105(1), or Article 105(4); (b) globally in respect of all amounts of import or export duty entered in the accounts in accordance with the first subparagraph of Article 105(1) during a period fixed by the customs authorities and not exceeding 31 days; (c) globally in respect of all amounts of import or export duty forming a single entry in accordance with the second subparagraph of Article 105(1). Article 111 Periods for which payment is deferred 1. The period for which payment is deferred under Article 110 shall be 30 days. 2. Where payment is deferred in accordance with point (a) of Article 110, the period shall begin on the day following that on which the customs debt is notified to the debtor. 3. Where payment is deferred in accordance with point (b) of Article 110, the period shall begin on the day following that on which the aggregation period ends. It shall be reduced by the number of days corresponding to half the number of days covered by the aggregation period. 4. Where payment is deferred in accordance with point (c) of Article 110, the period shall begin on the day following the end of the period fixed for release of the goods in question. It shall be reduced by the number of days corresponding to half the number of days covered by the period concerned. 5. Where the number of days in the periods referred to in paragraphs 3 and 4 is an odd number, the number of days to be deducted from the 30-day period pursuant to those paragraphs shall be equal to half the next lowest even number. 6. Where the periods referred to in paragraphs 3 and 4 are weeks, Member States may provide that the amount of import or export duty in respect of which payment has been deferred is to be paid on the Friday of the fourth week following the week in question at the latest. If those periods are months, Member States may provide that the amount of import or export duty in respect of which payment has been deferred is to be paid by the 16th day of the month following the month in question. Article 112 Other payment facilities 1. The customs authorities may grant the debtor payment facilities other than deferred payment on condition that a guarantee is provided. 2. Where facilities are granted pursuant to paragraph 1, credit interest shall be charged on the amount of import or export duty. For a Member State whose currency is the euro, the rate of credit interest shall be equal to the interest rate as published in the Official Journal of the European Union, C series, which the European Central Bank applied to its main refinancing operations, on the first day of the month in which the due date fell, increased by one percentage point. For a Member State whose currency is not the euro, the rate of credit interest shall be equal to the rate applied on the first day of the month in question by the National Central Bank for its main refinancing operations, increased by one percentage point, or, for a Member State for which the National Central Bank rate is not available, the most equivalent rate applied on the first day of the month in question on the Member State's money market, increased by one percentage point. 3. The customs authorities may refrain from requiring a guarantee or from charging credit interest where it is established, on the basis of a documented assessment of the situation of the debtor, that this would create serious economic or social difficulties. 4. The customs authorities shall refrain from charging credit interest where the amount for each recovery action is less than EUR 10. Article 113 Enforcement of payment Where the amount of import or export duty payable has not been paid within the prescribed period, the customs authorities shall secure payment of that amount by all means available to them under the law of the Member State concerned. Article 114 Interest on arrears 1. Interest on arrears shall be charged on the amount of import or export duty from the date of expiry of the prescribed period until the date of payment. For a Member State whose currency is the euro, the rate of interest on arrears shall be equal to the interest rate as published in the Official Journal of the European Union, C series, which the European Central Bank applied to its main refinancing operations, on the first day of the month in which the due date fell, increased by two percentage points. For a Member State whose currency is not the euro, the rate of interest on arrears shall be equal to the rate applied on the first day of the month in question by the National Central Bank for its main refinancing operations, increased by two percentage points, or, for a Member State for which the National Central Bank rate is not available, the most equivalent rate applied on the first day of the month in question on the Member State's money market, increased by two percentage points. 2. Where the customs debt is incurred on the basis of Article 79 or 82, or where the notification of the customs debt results from a post-release control, interest on arrears shall be charged over and above the amount of import or export duty, from the date on which the customs debt was incurred until the date of its notification. The rate of interest on arrears shall be set in accordance with paragraph 1. 3. The customs authorities may refrain from charging interest on arrears where it is established, on the basis of a documented assessment of the situation of the debtor, that to charge it would create serious economic or social difficulties. 4. The customs authorities shall refrain from charging interest on arrears where the amount for each recovery action is less than EUR 10. Article 115 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the rules for the suspension of the time-limit for payment of the amount of import or export duty corresponding to a customs debt referred to in Article 108(3) and the period of suspension. Section 3 Repayment and remission Article 116 General provisions 1. Subject to the conditions laid down in this Section, amounts of import or export duty shall be repaid or remitted on any of the following grounds: (a) overcharged amounts of import or export duty; (b) defective goods or goods not complying with the terms of the contract; (c) error by the competent authorities; (d) equity. Where an amount of import or export duty has been paid and the corresponding customs declaration is invalidated in accordance with Article 174, that amount shall be repaid. 2. The customs authorities shall repay or remit the amount of import or export duty referred to in paragraph 1 where it is EUR 10 or more, except where the person concerned requests the repayment or remission of a lower amount. 3. Where the customs authorities consider that repayment or remission should be granted on the basis of Article 119 or 120, the Member State concerned shall transmit the file to the Commission for decision in any of the following cases: (a) where the customs authorities consider that the special circumstances are the result of the Commission failing in its obligations; (b) where the customs authorities consider that the Commission committed an error within the meaning of Article 119; (c) where the circumstances of the case relate to the findings of a Union investigation carried out under Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters (17), or under any other Union legislation or any agreement concluded by the Union with countries or groups of countries in which provision is made for carrying out such Union investigations; (d) where the amount for which the person concerned may be liable in respect of one or more import or export operations equals or exceeds EUR 500 000 as a result of an error or special circumstances. Notwithstanding the first subparagraph, files shall not be transmitted in either of the following situations: (a) where the Commission has already adopted a decision on a case involving comparable issues of fact and of law; (b) where the Commission is already considering a case involving comparable issues of fact and of law. 4. Subject to the rules of competence for a decision, where the customs authorities themselves discover within the periods referred to in Article 121(1) that an amount of import or export duty is repayable or remissible pursuant to Articles 117, 119 or 120 they shall repay or remit on their own initiative. 5. No repayment or remission shall be granted when the situation which led to the notification of the customs debt results from deception by the debtor. 6. Repayment shall not give rise to the payment of interest by the customs authorities concerned. However, interest shall be paid where a decision granting repayment is not implemented within three months of the date on which that decision was taken, unless the failure to meet the deadline was outside the control of the customs authorities. In such cases, the interest shall be paid from the date of expiry of the three-month period until the date of repayment. The rate of interest shall be established in accordance with Article 112. 7. Where the customs authorities have granted repayment or remission in error, the original customs debt shall be reinstated insofar as it is not time-barred under Article 103. In such cases, any interest paid under the second subparagraph of paragraph 5 shall be reimbursed. Article 117 Overcharged amounts of import or export duty 1. An amount of import or export duty shall be repaid or remitted insofar as the amount corresponding to the customs debt initially notified exceeds the amount payable, or the customs debt was notified to the debtor contrary to points (c) or (d) of Article 102(1). 2. Where the application for repayment or remission is based on the existence, at the time when the declaration for release for free circulation was accepted, of a reduced or zero rate of import duty on the goods under a tariff quota, a tariff ceiling or other favourable tariff measures, repayment or remission shall be granted provided that, at the time of lodging the application accompanied by the necessary documents, either of the following conditions are fulfilled: (a) in the case of a tariff quota, its volume has not been exhausted; (b) in other cases, the rate of duty normally due has not been re-established. Article 118 Defective goods or goods not complying with the terms of the contract 1. An amount of import duty shall be repaid or remitted if the notification of the customs debt relates to goods which have been rejected by the importer because, at the time of release, they were defective or did not comply with the terms of the contract on the basis of which they were imported. Defective goods shall be deemed to include goods damaged before their release. 2. Notwithstanding paragraph 3, repayment or remission shall be granted provided the goods have not been used, except for such initial use as may have been necessary to establish that they were defective or did not comply with the terms of the contract and provided they are taken out of the customs territory of the Union. 3. Repayment or remission shall not be granted where: (a) the goods, before being released for free circulation, were placed under a special procedure for testing, unless it is established that the fact that the goods were defective or did not comply with the terms of the contract could not normally have been detected in the course of such tests; (b) the defective nature of the goods was taken into consideration in drawing up the terms of the contract, in particular the price, before the goods were placed under a customs procedure involving the incurrence of a customs debt; or (c) the goods are sold by the applicant after it has been ascertained that they are defective or do not comply with the terms of the contract. 4. Instead of being taken out of the customs territory of the Union, and upon application by the person concerned, the customs authorities shall authorise that the goods be placed under the inward processing procedure, including for destruction, or the external transit, the customs warehousing or the free zone procedure. Article 119 Error by the competent authorities 1. In cases other than those referred to in the second subparagraph of Article 116(1) and in Articles 117, 118 and 120, an amount of import or export duty shall be repaid or remitted where, as a result of an error on the part of the competent authorities, the amount corresponding to the customs debt initially notified was lower than the amount payable, provided the following conditions are met: (a) the debtor could not reasonably have detected that error; and (b) the debtor was acting in good faith. 2. Where the conditions laid down in Article 117(2) are not fulfilled, repayment or remission shall be granted where failure to apply the reduced or zero rate of duty was as a result of an error on the part of the customs authorities and the customs declaration for release for free circulation contained all the particulars and was accompanied by all the documents necessary for application of the reduced or zero rate. 3. Where the preferential treatment of the goods is granted on the basis of a system of administrative cooperation involving the authorities of a country or territory outside the customs territory of the Union, the issue of a certificate by those authorities, should it prove to be incorrect, shall constitute an error which could not reasonably have been detected within the meaning of point (a) of paragraph 1. The issue of an incorrect certificate shall not, however, constitute an error where the certificate is based on an incorrect account of the facts provided by the exporter, except where it is evident that the issuing authorities were aware or should have been aware that the goods did not satisfy the conditions laid down for entitlement to the preferential treatment. The debtor shall be considered to be in good faith if he or she can demonstrate that, during the period of the trading operations concerned, he or she has taken due care to ensure that all the conditions for the preferential treatment have been fulfilled. The debtor may not rely on a plea of good faith if the Commission has published a notice in the Official Journal of the European Union stating that there are grounds for doubt concerning the proper application of the preferential arrangements by the beneficiary country or territory. Article 120 Equity 1. In cases other than those referred to in the second subparagraph of Article 116(1) and in Articles 117, 118 and 119 an amount of import or export duty shall be repaid or remitted in the interest of equity where a customs debt is incurred under special circumstances in which no deception or obvious negligence may be attributed to the debtor. 2. The special circumstances referred to in paragraph 1 shall be deemed to exist where it is clear from the circumstances of the case that the debtor is in an exceptional situation as compared with other operators engaged in the same business, and that, in the absence of such circumstances, he or she would not have suffered disadvantage by the collection of the amount of import or export duty. Article 121 Procedure for repayment and remission 1. Applications for repayment or remission in accordance with Article 116 shall be submitted to the customs authorities within the following periods: (a) in the case of overcharged, amounts of import or export duty, error by the competent authorities or equity, within three years of the date of notification of the customs debt; (b) in the case of defective goods or goods not complying with the terms of the contract, within one year of the date of notification of the customs debt; (c) in the case of invalidation of a customs declaration, within the period specified in the rules applicable to invalidation. The period specified in points (a) and (b) of the first subparagraph shall be extended where the applicant provides evidence that he or she was prevented from submitting an application within the prescribed period as a result of unforeseeable circumstances or force majeure. 2. Where the customs authorities are not in a position, on the basis of the grounds adduced, to grant repayment or remission of an amount of import or export duty, it is required to examine the merits of an application for repayment or remission in the light of the other grounds for repayment or remission referred to in Article 116. 3. Where an appeal has been lodged under Article 44 against the notification of the customs debt, the relevant period specified in the first subparagraph of paragraph 1 shall be suspended, from the date on which the appeal is lodged, for the duration of the appeal proceedings. 4. Where a customs authority grants repayment or remission in accordance with Articles 119 and 120, the Member State concerned shall inform the Commission thereof. Article 122 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, laying down the rules with which it has to comply when taking a decision referred to in Article 116(3) and in particular on the following: (a) the conditions for the acceptance of the file; (b) the time-limit to take a decision and the suspension of that time-limit; (c) the communication of the grounds on which the Commission intends to base its decision, before taking a decision which would adversely affect the person concerned; (d) the notification of the decision; (e) the consequences of a failure to take a decision or to notify such decision. Article 123 Conferral of implementing powers 1. The Commission shall specify, by means of implementing acts, the procedural rules for: (a) repayment and remission, as referred to in Article 116; (b) informing the Commission in accordance with Article 121(4) and the information to be provided. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). 2. The Commission shall adopt the decision referred to in Article 116(3) by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 285(2). Where the opinion of the committee referred to in Article 285(1) is to be obtained by written procedure, Article 285(6) shall apply. CHAPTER 4 Extinguishment of a customs debt Article 124 Extinguishment 1. Without prejudice to the provisions in force relating to non-recovery of the amount of import or export duty corresponding to a customs debt in the event of the judicially established insolvency of the debtor, a customs debt on import or export shall be extinguished in any of the following ways: (a) where the debtor can no longer be notified of the customs debt, in accordance with Article 103; (b) by payment of the amount of import or export duty; (c) subject to paragraph 5, by remission of the amount of import or export duty; (d) where, in respect of goods declared for a customs procedure entailing the obligation to pay import or export duty, the customs declaration is invalidated; (e) where goods liable to import or export duty are confiscated or seized and simultaneously or subsequently confiscated; (f) where goods liable to import or export duty are destroyed under customs supervision or abandoned to the State; (g) where the disappearance of the goods or the non-fulfilment of obligations arising from the customs legislation results from the total destruction or irretrievable loss of those goods as a result of the actual nature of the goods or unforeseeable circumstances or force majeure, or as a consequence of instruction by the customs authorities; for the purpose of this point, goods shall be considered as irretrievably lost when they have been rendered unusable by any person; (h) where the customs debt was incurred pursuant to Article 79 or 82 and where the following conditions are fulfilled: (i) the failure which led to the incurrence of a customs debt had no significant effect on the correct operation of the customs procedure concerned and did not constitute an attempt at deception; (ii) all of the formalities necessary to regularise the situation of the goods are subsequently carried out; (i) where goods released for free circulation duty-free, or at a reduced rate of import duty by virtue of their end-use, have been exported with the permission of the customs authorities; (j) where it was incurred pursuant to Article 78 and where the formalities carried out in order to enable the preferential tariff treatment referred to in that Article to be granted are cancelled; (k) where, subject to paragraph 6, the customs debt was incurred pursuant to Article 79 and evidence is provided to the satisfaction of the customs authorities that the goods have not been used or consumed and have been taken out of the customs territory of the Union. 2. In the cases referred to in point (e) of paragraph 1, the customs debt shall, nevertheless, for the purposes of penalties applicable to customs offences, be deemed not to have been extinguished where, under the law of a Member State, import or export duty or the existence of a customs debt provide the basis for determining penalties. 3. Where, in accordance with point (g) of paragraph 1, a customs debt is extinguished in respect of goods released for free circulation duty-free or at a reduced rate of import duty on account of their end-use, any scrap or waste resulting from their destruction shall be deemed to be non-Union goods. 4. The provisions in force pertaining to standard rates for irretrievable loss due to the nature of goods shall apply where the person concerned fails to show that the real loss exceeds that calculated by applying the standard rate for the goods in question. 5. Where several persons are liable for payment of the amount of import or export duty corresponding to the customs debt and remission is granted, the customs debt shall be extinguished only in respect of the person or persons to whom the remission is granted. 6. In the case referred to in point (k) of paragraph 1, the customs debt shall not be extinguished in respect of any person or persons who attempted deception. 7. Where the customs debt was incurred pursuant to Article 79, it shall be extinguished with regard to the person whose behaviour did not involve any attempt at deception and who contributed to the fight against fraud. Article 125 Application of penalties Where the customs debt is extinguished on the basis of point (h) of Article 124(1), Member States shall not be precluded from the application of penalties for failure to comply with the customs legislation. Article 126 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the list of failures with no significant effect on the correct operation of the customs procedure concerned and to supplement point (i) of point (h) of Article 124(1). TITLE IV GOODS BROUGHT INTO THE CUSTOMS TERRITORY OF THE UNION CHAPTER 1 Entry summary declaration Article 127 Lodging of an entry summary declaration 1. Goods brought into the customs territory of the Union shall be covered by an entry summary declaration. 2. The obligation referred to in paragraph 1 shall be waived: (a) for means of transport and the goods carried thereon only passing through the territorial waters or the airspace of the customs territory of the Union without a stop within that territory; and (b) in other cases, where duly justified by the type of goods or traffic, or where required by international agreements. 3. The entry summary declaration shall be lodged at the customs office of first entry within a specific time-limit, before the goods are brought into the customs territory of the Union. Customs authorities may allow the entry summary declaration to be lodged at another customs office, provided that the latter immediately communicates or makes available electronically the necessary particulars to the customs office of first entry. 4. The entry summary declaration shall be lodged by the carrier. Notwithstanding the obligations of the carrier, the entry summary declaration may be lodged instead by one of the following persons: (a) the importer or consignee or other person in whose name or on whose behalf the carrier acts; (b) any person who is able to present the goods in question or have them presented at the customs office of entry. 5. The entry summary declaration shall contain the particulars necessary for risk analysis for security and safety purposes. 6. In specific cases, where all the particulars referred to in paragraph 5 cannot be obtained from the persons referred to in paragraph 4, other persons holding those particulars and the appropriate rights to provide them may be required to provide those particulars. 7. Customs authorities may accept that commercial, port or transport information systems are used for the lodging of an entry summary declaration provided such systems contain the necessary particulars for such declaration and those particulars are available within a specific time-limit, before the goods are brought into the customs territory of the Union. 8. Customs authorities may accept, instead of the lodging of the entry summary declaration, the lodging of a notification and access to the particulars of an entry summary declaration in the economic operator's computer system. Article 128 Risk analysis The customs office referred to in Article 127(3) shall, within a specific time-limit, ensure that a risk analysis is carried out, primarily for security and safety purposes, on the basis of the entry summary declaration referred to in Article 127(1) or the particulars referred to in Article 127(8) and shall take the necessary measures based on the results of that risk analysis. Article 129 Amendment and invalidation of an entry summary declaration 1. The declarant may, upon application, be permitted to amend one or more particulars of the entry summary declaration after it has been lodged. No amendment shall be possible after any of the following: (a) the customs authorities have informed the person who lodged the entry summary declaration that they intend to examine the goods; (b) the customs authorities have established that the particulars of the entry summary declaration are incorrect; (c) the goods have already been presented to customs. 2. When the goods for which an entry summary declaration has been lodged are not brought into the customs territory of the Union, the customs authorities shall invalidate that declaration in either of the following cases: (a) upon application by the declarant; (b) within 200 days after the lodging of the declaration. Article 130 Declarations lodged instead of an entry summary declaration 1. The customs office referred to in Article 127(3) may waive the lodging of an entry summary declaration in respect of goods for which, prior to the expiry of the time-limit for lodging that declaration, a customs declaration is lodged. In that case, the customs declaration shall contain at least the particulars necessary for the entry summary declaration. Until such time as the customs declaration is accepted in accordance with Article 172, it shall have the status of an entry summary declaration. 2. The customs office referred to in Article 127(3) may waive the lodging of an entry summary declaration in respect of goods for which, prior to the expiry of the time-limit for lodging that declaration, a temporary storage declaration is lodged. That declaration shall contain at least the particulars necessary for the entry summary declaration. Until such time as the goods declared are presented to customs in accordance with Article 139, the temporary storage declaration shall have the status of an entry summary declaration. Article 131 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, in order to determine: (a) the cases where the obligation to lodge an entry summary declaration is waived, in accordance with point (c) of Article 127(2); (b) the specific time-limit referred to in Article 127(3) and (7), within which the entry summary declaration is to be lodged before the goods are brought into the customs territory of the Union, taking into account the type of goods or traffic; (c) the cases referred to in Article 127(6) and the other persons who may be required to provide particulars of the entry summary declaration in those cases. Article 132 Conferral of implementing powers The Commission shall specify, by means of implementing acts: (a) the procedural rules for lodging the entry summary declaration referred to in Article 127; (b) the procedural rules and the provision of particulars of the entry summary declaration by the other persons referred to in Article 127(6); (c) the time-limit within which a risk analysis is to be carried out and the necessary measures to be taken, in accordance with Article 128; (d) the procedural rules for amending the entry summary declaration, in accordance with Article 129(1); (e) the procedural rules for invalidating the entry summary declaration in accordance with Article 129(2), taking into account the proper management of the entry of the goods. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 2 Arrival of goods Section 1 Entry of goods into the customs territory of the Union Article 133 Notification of arrival of a sea-going vessel or of an aircraft 1. The operator of a sea-going vessel or of an aircraft entering the customs territory of the Union shall notify the arrival to the customs office of first entry upon arrival of the means of transport. Where information on arrival of a sea-going vessel or of an aircraft is available to the customs authorities they may waive the notification referred to in the first subparagraph. 2. Customs authorities may accept that port or airport systems or other available methods of information be used to notify the arrival of the means of transport. Article 134 Customs supervision 1. Goods brought into the customs territory of the Union shall, from the time of their entry, be subject to customs supervision and may be subject to customs controls. Where applicable, they shall be subject to such prohibitions and restrictions as are justified on grounds of, inter alia, public morality, public policy or public security, the protection of the health and life of humans, animals or plants, the protection of the environment, the protection of national treasures possessing artistic, historic or archaeological value and the protection of industrial or commercial property, including controls on drug precursors, goods infringing certain intellectual property rights and cash, as well as to the implementation of fishery conservation and management measures and of commercial policy measures. They shall remain under such supervision for as long as is necessary to determine their customs status and shall not be removed therefrom without the permission of the customs authorities. Without prejudice to Article 254, Union goods shall not be subject to customs supervision once their customs status is established. Non-Union goods shall remain under customs supervision until their customs status is changed, or they are taken out of the customs territory of the Union or destroyed. 2. The holder of goods under customs supervision may, with the permission of the customs authorities, at any time examine the goods or take samples, in particular in order to determine their tariff classification, customs value or customs status. Article 135 Conveyance to the appropriate place 1. The person who brings goods into the customs territory of the Union shall convey them without delay, by the route specified by the customs authorities and in accordance with their instructions, if any, to the customs office designated by the customs authorities, or to any other place designated or approved by those authorities, or into a free zone. 2. Goods brought into a free zone shall be brought into that free zone directly, either by sea or air or, if by land, without passing through another part of the customs territory of the Union, where the free zone adjoins the land frontier between a Member State and a third country. 3. Any person who assumes responsibility for the carriage of goods after they have been brought into the customs territory of the Union shall become responsible for compliance with the obligations laid down in paragraphs 1 and 2. 4. Goods which, although still outside the customs territory of the Union, may be subject to customs controls by the customs authority of a Member State as a result of an agreement concluded with the relevant country or territory outside the customs territory of the Union, shall be treated in the same way as goods brought into the customs territory of the Union. 5. Paragraphs 1 and 2 shall not preclude application of special rules with respect to goods transported within frontier zones or in pipelines and wires as well as for traffic of negligible economic importance such as letters, postcards and printed matter and their electronic equivalents held on other media or to goods carried by travellers, provided that customs supervision and customs control possibilities are not thereby jeopardised. 6. Paragraph 1 shall not apply to means of transport and goods carried thereon only passing through the territorial waters or the airspace of the customs territory of the Union without a stop within that territory. Article 136 Intra-Union air and sea services Articles 127 to 130 and 133, Article 135(1) and Articles 137, 139 to 141, and 144 to 149 shall not apply to non-Union goods and goods referred to in Article 155, which have temporarily left the customs territory of the Union while moving between two points in that territory by sea or air, provided they have been carried by direct route without a stop outside the customs territory of the Union. Article 137 Conveyance under special circumstances 1. Where, by reason of unforeseeable circumstances or force majeure, the obligation laid down in Article 135(1) cannot be complied with, the person bound by that obligation or any other person acting on that person's behalf shall inform the customs authorities of the situation without delay. Where the unforeseeable circumstances or force majeure do not result in total loss of the goods, the customs authorities shall also be informed of their precise location. 2. Where, by reason of unforeseeable circumstances or force majeure, a vessel or aircraft covered by Article 135(6) is forced to put into port or to land temporarily in the customs territory of the Union and the obligation laid down in Article 135(1) cannot be complied with, the person who brought the vessel or aircraft into the customs territory of the Union, or any other person acting on that person's behalf, shall inform the customs authorities of the situation without delay. 3. The customs authorities shall determine the measures to be taken in order to permit customs supervision of the goods referred to in paragraph 1, or of the vessel or aircraft and any goods thereon in the circumstances specified in paragraph 2, and to ensure, where appropriate, that they are subsequently conveyed to a customs office or other place designated or approved by the authorities. Article 138 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules on: (a) the notification of arrival referred to in Article 133; (b) the conveyance of goods referred to in Article 135(5). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Presentation, unloading and examination of goods Article 139 Presentation of goods to customs 1. Goods brought into the customs territory of the Union shall be presented to customs immediately upon their arrival at the designated customs office or any other place designated or approved by the customs authorities or in the free zone by one of the following persons: (a) the person who brought the goods into the customs territory of the Union; (b) the person in whose name or on whose behalf the person who brought the goods into that territory acts; (c) the person who assumed responsibility for carriage of the goods after they were brought into the customs territory of the Union. 2. Goods which are brought into the customs territory of the Union by sea or air and which remain on board the same means of transport for carriage, shall be presented to customs only at the port or airport where they are unloaded or transhipped. However, goods brought into the customs territory of the Union which are unloaded and reloaded onto the same means of transport during its voyage in order to enable the unloading or loading of other goods, shall not be presented to customs at that port or airport. 3. Notwithstanding the obligations of the person described in paragraph 1, presentation of the goods may be effected instead by one of the following persons: (a) any person who immediately places the goods under a customs procedure; (b) the holder of an authorisation for the operation of storage facilities or any person who carries out an activity in a free zone. 4. The person presenting the goods shall make a reference to the entry summary declaration or, in the cases referred to in Article 130, the customs declaration or temporary storage declaration which has been lodged in respect of the goods, except where the obligation to lodge an entry summary declaration is waived. 5. Where non-Union goods presented to customs are not covered by an entry summary declaration, and except where the obligation to lodge such declaration is waived, one of the persons referred to in Article 127(4) shall, without prejudice to Article 127(6), lodge immediately such declaration or shall instead lodge a customs declaration or temporary storage declaration. 6. Paragraph 1 shall not preclude application of special rules with respect to goods transported within frontier zones or in pipelines and wires as well as for traffic of negligible economic importance such as letters, postcards and printed matter and their electronic equivalents held on other media or to goods carried by travellers, provided that customs supervision and customs control possibilities are not thereby jeopardised. 7. Goods presented to customs shall not be removed from the place where they have been presented without the permission of the customs authorities. Article 140 Unloading and examination of goods 1. Goods shall be unloaded or trans-shipped from the means of transport carrying them solely with the authorisation of the customs authorities in places designated or approved by those authorities. However, such authorisation shall not be required in the event of an imminent danger necessitating the immediate unloading of all or part of the goods. In that case, the customs authorities shall immediately be informed accordingly. 2. The customs authorities may at any time require goods to be unloaded and unpacked for the purpose of examining them, taking samples or examining the means of transport carrying them. Article 141 Goods moved under transit 1. Article 135(2) to (6) and Articles 139, 140 and 144 to 149 shall not apply when goods already under a transit procedure are brought into the customs territory of the Union. 2. Articles 140 and 144 to 149 shall apply to non-Union goods moved under a transit procedure, once such goods have been presented to the customs office of destination in the customs territory of the Union in accordance with the rules governing the transit procedure. Article 142 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, in order to determine the conditions for approving the places referred to in Article 139(1). Article 143 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules regarding the presentation of goods to customs referred to in Article 139. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 3 Temporary storage of goods Article 144 Goods in temporary storage Non-Union goods shall be in temporary storage from the moment they are presented to customs. Article 145 Temporary storage declaration 1. Non-Union goods presented to customs shall be covered by a temporary storage declaration containing all the particulars necessary for the application of the provisions governing temporary storage. 2. Documents related to goods in temporary storage shall be provided to the customs authorities where Union legislation so requires or where necessary for customs controls. 3. The temporary storage declaration shall be lodged by one of the persons referred to in Article 139(1) or (2) at the latest at the time of the presentation of the goods to customs. 4. The temporary storage declaration shall, unless the obligation to lodge an entry summary declaration is waived, include a reference to any entry summary declaration lodged for the goods presented to customs, except where they have already been in temporary storage or have been placed under a customs procedure and have not left the customs territory of the Union. 5. Customs authorities may accept that the temporary storage declaration also takes one of the following forms: (a) a reference to any entry summary declaration lodged for the goods concerned, supplemented by the particulars of a temporary storage declaration; (b) a manifest or another transport document, provided that it contains the particulars of a temporary storage declaration, including a reference to any entry summary declaration for the goods concerned. 6. Customs authorities may accept that commercial, port or transport information systems are used to lodge a temporary storage declaration provided that they contain the necessary particulars for such declaration and these particulars are available in accordance with paragraph 3. 7. Articles 188 to 193 shall apply to the temporary storage declaration. 8. The temporary storage declaration may be used also for the purpose of: (a) the notification of arrival referred to in Article 133; or (b) the presentation of the goods to customs referred to in Article 139, insofar as it fulfils the conditions laid down in those provisions. 9. A temporary storage declaration shall not be required where, at the latest at the time of the presentation of the goods to customs, their customs status as Union goods is determined in accordance with Articles 153 to 156. 10. The temporary storage declaration shall be kept by, or be accessible to, the customs authorities for the purpose of verifying that the goods to which it relates are subsequently placed under a customs procedure or re-exported in accordance with Article 149. 11. For the purpose of paragraphs 1 to 10, where non-Union goods moved under a transit procedure are presented to customs at an office of destination within the customs territory of the Union, the particulars for the transit operation concerned shall be deemed to be the temporary storage declaration, provided they meet the requirements for that purpose. However, the holder of the goods may lodge a temporary storage declaration after the end of the transit procedure. Article 146 Amendment and invalidation of a temporary storage declaration 1. The declarant shall, upon application, be permitted to amend one or more particulars of the temporary storage declaration after it has been lodged. The amendment shall not render the declaration applicable to goods other than those which it originally covered. No amendment shall be possible after any of the following: (a) the customs authorities have informed the person who lodged the declaration that they intend to examine the goods; (b) the customs authorities have established that particulars of the declaration are incorrect. 2. Where the goods for which a temporary storage declaration has been lodged are not presented to customs, the customs authorities shall invalidate that declaration in either of the following cases: (a) upon application by the declarant; (b) within 30 days after the lodging of the declaration. Article 147 Conditions and responsibilities for the temporary storage of goods 1. Goods in temporary storage shall be stored only in temporary storage facilities in accordance with Article 148 or, where justified, in other places designated or approved by the customs authorities. 2. Without prejudice to Article 134(2), goods in temporary storage shall be subject only to such forms of handling as are designed to ensure their preservation in an unaltered state without modifying their appearance or technical characteristics. 3. The holder of the authorisation referred to in Article 148 or the person storing the goods in the cases where the goods are stored in other places designated or approved by the customs authorities, shall be responsible for all of the following: (a) ensuring that goods in temporary storage are not removed from customs supervision; (b) fulfilling the obligations arising from the storage of goods in temporary storage. 4. Where, for any reason, goods cannot be maintained in temporary storage, the customs authorities shall without delay take all measures necessary to regularise the situation of the goods in accordance with Articles 197, 198 and 199. Article 148 Authorisation for the operation of temporary storage facilities 1. An authorisation from the customs authorities shall be required for the operation of temporary storage facilities. Such authorisation shall not be required where the operator of the temporary storage facility is the customs authority itself. The conditions under which the operation of temporary storage facilities is permitted shall be set out in the authorisation. 2. The authorisation referred to in paragraph 1 shall be granted only to persons who satisfy all of the following conditions: (a) they are established in the customs territory of the Union; (b) they provide the necessary assurance of the proper conduct of the operations; an authorised economic operator for customs simplifications shall be deemed to fulfil that condition insofar as the operation of temporary storage facilities is taken into account in the authorisation referred to in point (a) of Article 38(2); (c) they provide a guarantee in accordance with Article 89. Where a comprehensive guarantee is provided, compliance with the obligations attached to that guarantee shall be monitored by appropriate audit. 3. The authorisation referred to in paragraph 1 shall be granted only where the customs authorities are able to exercise customs supervision without having to introduce administrative arrangements which are disproportionate to the economic needs involved. 4. The holder of the authorisation shall keep appropriate records in a form approved by the customs authorities. The records shall contain the information and the particulars which enable the customs authorities to supervise the operation of the temporary storage facilities, in particular with regard to the identification of the goods stored, their customs status and their movements. An authorised economic operator for customs simplifications shall be deemed to comply with the obligation referred to in the first and second subparagraphs, insofar as his or her records are appropriate for the purpose of the operation of temporary storage. 5. The customs authorities may authorise the holder of the authorisation to move goods in temporary storage between different temporary storage facilities under the condition that such movements would not increase the risk of fraud, as follows: (a) such movement takes place under the responsibility of one customs authority; (b) such movement is covered by only one authorisation, issued to an authorised economic operator for customs simplifications; or (c) in other cases of movement. 6. The customs authorities may, where an economic need exists and customs supervision will not be adversely affected, authorise the storage of Union goods in a temporary storage facility. Those goods shall not be regarded as goods in temporary storage. Article 149 End of temporary storage Non-Union goods in temporary storage shall be placed under a customs procedure or re-exported within 90 days. Article 150 Choice of a customs procedure Except where otherwise provided, the declarant shall be free to choose the customs procedure under which to place the goods, under the conditions for that procedure, irrespective of their nature or quantity, or their country of origin, consignment or destination. Article 151 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the conditions for approving the places referred to in Article 147(1); (b) the conditions for granting the authorisation for the operation of temporary storage facilities, referred to in Article 148; (c) the cases of movement referred to in point (c) of Article 148(5). Article 152 Conferral of implementing power The Commission shall specify, by means of implementing acts, the procedural rules for: (a) lodging the temporary storage declaration referred to in Article 145; (b) amending the temporary storage declaration, in accordance with Article 146(1); (c) invalidating the temporary storage declaration, in accordance with Article 146(2); (d) the movement of goods in temporary storage referred to in Article 148(5). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). TITLE V GENERAL RULES ON CUSTOMS STATUS, PLACING GOODS UNDER A CUSTOMS PROCEDURE, VERIFICATION, RELEASE AND DISPOSAL OF GOODS CHAPTER 1 Customs status of goods Article 153 Presumption of customs status of Union goods 1. All goods in the customs territory of the Union shall be presumed to have the customs status of Union goods, unless it is established that they are not Union goods. 2. In specific cases, where the presumption laid down in paragraph 1 does not apply, the customs status of Union goods shall need to be proven. 3. In specific cases, goods wholly obtained in the customs territory of the Union do not have the customs status of Union goods if they are obtained from goods in temporary storage or placed under the external transit procedure, a storage procedure, the temporary admission procedure or the inward processing procedure. Article 154 Loss of customs status of Union goods Union goods shall become non-Union goods in the following cases: (a) where they are taken out of the customs territory of the Union, insofar as the rules on internal transit do not apply; (b) where they have been placed under the external transit procedure, a storage procedure or the inward processing procedure, insofar as the customs legislation so allows; (c) where they have been placed under the end-use procedure and are either subsequently abandoned to the State, or are destroyed and waste remains; (d) where the declaration for release for free circulation is invalidated after release of the goods. Article 155 Union goods leaving the customs territory of the Union temporarily 1. In the cases referred to in points (b) to (f) of Article 227(2), goods shall keep their customs status as Union goods only if that status is established under certain conditions and by means laid down in the customs legislation. 2. In specific cases, Union goods may move, without being subject to a customs procedure, from one point to another within the customs territory of the Union and temporarily out of that territory without alteration of their customs status. Article 156 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the cases where the presumption laid down in Article 153(1) does not apply; (b) the conditions for granting facilitation in the establishment of the proof of customs status of Union goods; (c) the cases where the goods referred to in Article 153(3) do not have the customs status of Union goods; (d) the cases where the customs status of goods referred to in Article 155(2) is not altered. Article 157 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for the provision and verification of the proof of the customs status of Union goods. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 2 Placing goods under a customs procedure Section 1 General provisions Article 158 Customs declaration of goods and customs supervision of Union goods 1. All goods intended to be placed under a customs procedure, except for the free zone procedure, shall be covered by a customs declaration appropriate for the particular procedure. 2. In specific cases, other than those referred to in Article 6(2), a customs declaration may be lodged using means other than electronic data-processing techniques. 3. Union goods declared for export, internal Union transit or outward processing shall be subject to customs supervision from the time of acceptance of the declaration referred to in paragraph 1 until such time as they are taken out of the customs territory of the Union or are abandoned to the State or destroyed or the customs declaration is invalidated. Article 159 Competent customs offices 1. Except where Union legislation provides otherwise, Member States shall determine the location and competence of the various customs offices situated in their territory. 2. Member States shall ensure that official opening hours are fixed for those offices that are reasonable and appropriate, taking into account the nature of the traffic and of the goods and the customs procedures under which they are to be placed, so that the flow of international traffic is neither hindered nor distorted. 3. Except where otherwise provided, the competent customs office for placing the goods under a customs procedure shall be the customs office responsible for the place where the goods are presented to customs. Article 160 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the cases where a customs declaration may be lodged using means other than electronic data-processing techniques in accordance with Article 158(2). Article 161 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) determining the competent customs offices other than the one referred to in Article 159(3), including customs offices of entry and customs offices of exit; (b) lodging the customs declaration in the cases referred to in Article 158(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Standard customs declarations Article 162 Content of a standard customs declaration Standard customs declarations shall contain all the particulars necessary for application of the provisions governing the customs procedure for which the goods are declared. Article 163 Supporting documents 1. The supporting documents required for the application of the provisions governing the customs procedure for which the goods are declared shall be in the declarant's possession and at the disposal of the customs authorities at the time when the customs declaration is lodged. 2. Supporting documents shall be provided to the customs authorities where Union legislation so requires or where necessary for customs controls. 3. In specific cases, economic operators may draw up the supporting documents provided they are authorised to do so by the customs authorities. Article 164 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, laying down the rules for granting the authorisation referred to in Article 163(3). Article 165 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules: (a) for lodging the standard customs declaration referred to in Article 162; (b) on the making available of the supporting documents referred to in Article 163(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 3 Simplified customs declarations Article 166 Simplified declaration 1. The customs authorities may accept that a person has goods placed under a customs procedure on the basis of a simplified declaration which may omit certain of the particulars referred to in Article 162 or the supporting documents referred to in Article 163. 2. The regular use of a simplified declaration referred to in paragraph 1 shall be subject to an authorisation from the customs authorities. Article 167 Supplementary declaration 1. In the case of a simplified declaration pursuant to Article 166 or of an entry in the declarant's records pursuant to Article 182, the declarant shall lodge a supplementary declaration containing the particulars necessary for the customs procedure concerned at the competent customs office within a specific time-limit. In the case of a simplified declaration pursuant to Article 166, the necessary supporting documents shall be in the declarant's possession and at the disposal of the customs authorities within a specific time-limit. The supplementary declaration may be of a general, periodic or recapitulative nature. 2. The obligation to lodge a supplementary declaration shall be waived in the following cases: (a) where the goods are placed under a customs warehousing procedure; (b) in other specific cases. 3. The customs authorities may waive the requirement to lodge a supplementary declaration where the following conditions apply: (a) the simplified declaration concerns goods the value and quantity of which is below the statistical threshold; (b) the simplified declaration already contains all the information needed for the customs procedure concerned; and (c) the simplified declaration is not made by entry in the declarant's records. 4. The simplified declaration referred to in Article 166 or the entry in the declarant's records referred to in Article 182, and the supplementary declaration shall be deemed to constitute a single, indivisible instrument taking effect, respectively, on the date on which the simplified declaration is accepted in accordance with Article 172 and on the date on which the goods are entered in the declarant's records. 5. The place where the supplementary declaration is to be lodged shall be deemed, for the purposes of Article 87, to be the place where the customs declaration has been lodged. Article 168 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, in order to determine: (a) the conditions for granting the authorisation referred to in Article 166(2); (b) the specific time-limit referred to in the first subparagraph of Article 167(1) within which the supplementary declaration is to be lodged; (c) the specific time-limit referred to in the second subparagraph of Article 167(1) within which supporting documents are to be in the possession of the declarant; (d) the specific cases where the obligation to lodge a supplementary declaration is waived in accordance with point (b) of Article 167(2). Article 169 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for lodging: (a) the simplified declaration referred to in Article 166; (b) the supplementary declaration referred to in Article 167. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 4 Provisions applying to all customs declarations Article 170 Lodging a customs declaration 1. Without prejudice to Article 167(1), a customs declaration may be lodged by any person who is able to provide all of the information which is required for the application of the provisions governing the customs procedure in respect of which the goods are declared. That person shall also be able to present the goods in question or to have them presented to customs. However, where acceptance of a customs declaration imposes particular obligations on a specific person, that declaration shall be lodged by that person or by his or her representative. 2. The declarant shall be established in the customs territory of the Union. 3. By way of derogation from paragraph 2, the following declarants shall not be required to be established in the customs territory of the Union: (a) persons who lodge a customs declaration for transit or temporary admission; (b) persons, who occasionally lodge a customs declaration, including for end-use or inward processing, provided that the customs authorities consider this to be justified; (c) persons who are established in a country the territory of which is adjacent to the customs territory of the Union, and who present the goods to which the customs declaration refers at a Union border customs office adjacent to that country, provided that the country in which the persons are established grants reciprocal benefits to persons established in the customs territory of the Union. 4. Customs declarations shall be authenticated. Article 171 Lodging a customs declaration prior to the presentation of the goods A customs declaration may be lodged prior to the expected presentation of the goods to customs. If the goods are not presented within 30 days of lodging of the customs declaration, the customs declaration shall be deemed not to have been lodged. Article 172 Acceptance of a customs declaration 1. Customs declarations which comply with the conditions laid down in this Chapter shall be accepted by the customs authorities immediately, provided that the goods to which they refer have been presented to customs. 2. The date of acceptance of the customs declaration by the customs authorities shall, except where otherwise provided, be the date to be used for the application of the provisions governing the customs procedure for which the goods are declared and for all other import or export formalities. Article 173 Amendment of a customs declaration 1. The declarant shall, upon application, be permitted to amend one or more of the particulars of the customs declaration after that declaration has been accepted by customs. The amendment shall not render the customs declaration applicable to goods other than those which it originally covered. 2. No such amendment shall be permitted where it is applied for after any of the following events: (a) the customs authorities have informed the declarant that they intend to examine the goods; (b) the customs authorities have established that the particulars of the customs declaration are incorrect; (c) the customs authorities have released the goods. 3. Upon application by the declarant, within three years of the date of acceptance of the customs declaration, the amendment of the customs declaration may be permitted after release of the goods in order for the declarant to comply with his or her obligations relating to the placing of the goods under the customs procedure concerned. Article 174 Invalidation of a customs declaration 1. The customs authorities shall, upon application by the declarant, invalidate a customs declaration already accepted in either of the following cases: (a) where they are satisfied that the goods are immediately to be placed under another customs procedure; (b) where they are satisfied that, as a result of special circumstances, the placing of the goods under the customs procedure for which they were declared is no longer justified. However, where the customs authorities have informed the declarant of their intention to examine the goods, an application for invalidation of the customs declaration shall not be accepted before the examination has taken place. 2. The customs declaration shall not be invalidated after the goods have been released unless where otherwise provided. Article 175 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the cases where the customs declaration is invalidated after the release of the goods, as referred to in Article 174(2). Article 176 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) lodging a customs declaration in accordance with Article 171; (b) accepting a customs declaration as referred to in Article 172, including the application of those rules in the cases referred to in Article 179; (c) amending the customs declaration after the release of the goods in accordance with Article 173(3). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 5 Other simplifications Article 177 Simplification of the drawing-up of customs declarations for goods falling under different tariff subheadings 1. Where a consignment is made up of goods falling within different tariff subheadings, and dealing with each of those goods in accordance with its tariff subheading for the purpose of drawing-up the customs declaration would entail a burden of work and expense disproportionate to the import or export duty chargeable, the customs authorities may, upon application by the declarant, agree that import or export duty be charged on the whole consignment on the basis of the tariff subheading of the goods which are subject to the highest rate of import or export duty. 2. Customs authorities shall refuse the use of the simplification referred to in paragraph 1 to goods subject to prohibitions or restrictions or excise duty where the correct classification is necessary to apply the measure. Article 178 Conferral of implementing powers The Commission shall adopt, by means of implementing acts, measures for the determination of the tariff subheading for the application of Article 177(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 179 Centralised clearance 1. The customs authorities may, upon application, authorise a person to lodge at a customs office responsible for the place where such person is established, a customs declaration for goods which are presented to customs at another customs office. The requirement for the authorisation referred to in the first subparagraph may be waived where the customs declaration is lodged and the goods presented to customs offices under the responsibility of one customs authority. 2. The applicant for the authorisation referred to in paragraph 1 shall be an authorised economic operator for customs simplifications. 3. The customs office at which the customs declaration is lodged shall: (a) supervise the placing of the goods under the customs procedure concerned; (b) carry out the customs controls for the verification of the customs declaration, referred to in points (a) and (b) of Article 188; (c) where justified, request that the customs office at which the goods are presented carry out the customs controls for the verification of the customs declaration referred to in points (c) and (d) of Article 188; and (d) carry out the customs formalities for the recovery of the amount of import or export duty corresponding to any customs debt. 4. The customs office at which the customs declaration is lodged and the customs office at which the goods are presented shall exchange the information necessary for the verification of the customs declaration and for the release of the goods. 5. The customs office at which the goods are presented shall, without prejudice to its own controls pertaining to goods brought into or taken out of the customs territory of the Union, carry out the customs controls referred to in point (c) of paragraph 3 and provide the customs office at which the customs declaration is lodged with the results of these controls. 6. The customs office at which the customs declaration is lodged shall release the goods in accordance with Articles 194 and 195, taking into account: (a) the results of its own controls for the verification of the customs declaration; (b) the results of the controls carried out by the customs office at which the goods are presented for the verification of the customs declaration and the controls pertaining to goods brought into or taken out of the customs territory of the Union. Article 180 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the conditions for granting the authorisation referred to in the first subparagraph of Article 179(1). Article 181 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules concerning: (a) the centralised clearance, including the relevant customs formalities and controls, referred to in Article 179; (b) the waiver from the obligation for goods to be presented referred to in Article 182(3) in the context of centralised clearance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 182 Entry in the declarant's records 1. The customs authorities may, upon application, authorise a person to lodge a customs declaration, including a simplified declaration, in the form of an entry in the declarant's records, provided that the particulars of that declaration are at the disposal of the customs authorities in the declarant's electronic system at the time when the customs declaration in the form of an entry in the declarant's records is lodged. 2. The customs declaration shall be deemed to have been accepted at the moment at which the goods are entered in the records. 3. The customs authorities may, upon application, waive the obligation for the goods to be presented. In that case, the goods shall be deemed to have been released at the moment of entry in the declarant's records. That waiver may be granted where all of the following conditions are fulfilled: (a) the declarant is an authorised economic operator for customs simplifications; (b) the nature and flow of the goods concerned so warrant and are known by the customs authority; (c) the supervising customs office has access to all the information it considers necessary to enable it to exercise its right to examine the goods should the need arise; (d) at the time of the entry into the records, the goods are no longer subject to prohibitions or restrictions, except where otherwise provided in the authorisation. However, the supervising customs office may, in specific situations, request that the goods be presented. 4. The conditions under which the release of the goods is allowed shall be set out in the authorisation. Article 183 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the conditions for granting the authorisation referred to in Article 182(1). Article 184 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules on entry in the declarant's records referred to in Article 182, including the relevant customs formalities and controls. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 185 Self-assessment 1. Customs authorities may, upon application, authorise an economic operator to carry out certain customs formalities which are to be carried out by the customs authorities, to determine the amount of import and export duty payable, and to perform certain controls under customs supervision. 2. The applicant for the authorisation referred to in paragraph 1 shall be an authorised economic operator for customs simplifications. Article 186 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284, in order to determine: (a) the conditions for granting the authorisation referred to in Article 185(1); (b) the customs formalities and the controls to be carried out by the holder of the authorisation referred to in Article 185(1). Article 187 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules regarding the customs formalities and the controls to be carried out by the holder of the authorisation in accordance with Article 185(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 3 Verification and release of goods Section 1 Verification Article 188 Verification of a customs declaration The customs authorities may, for the purpose of verifying the accuracy of the particulars contained in a customs declaration which has been accepted: (a) examine the declaration and the supporting documents; (b) require the declarant to provide other documents; (c) examine the goods; (d) take samples for analysis or for detailed examination of the goods. Article 189 Examination and sampling of goods 1. Transport of the goods to the places where they are to be examined and where samples are to be taken, and all the handling necessitated by such examination or taking of samples, shall be carried out by or under the responsibility of the declarant. The costs incurred shall be borne by the declarant. 2. The declarant shall have the right to be present or represented when the goods are examined and when samples are taken. Where the customs authorities have reasonable grounds for so doing, they may require the declarant to be present or represented when the goods are examined or samples are taken or to provide them with the assistance necessary to facilitate such examination or taking of samples. 3. Provided that samples are taken in accordance with the provisions in force, the customs authorities shall not be liable for payment of any compensation in respect thereof but shall bear the costs of their analysis or examination. Article 190 Partial examination and sampling of goods 1. Where only part of the goods covered by a customs declaration is examined, or samples are taken, the results of the partial examination, or of the analysis or examination of the samples, shall be taken to apply to all the goods covered by the same declaration. However, the declarant may request a further examination or sampling of the goods if he or she considers that the results of the partial examination, or of the analysis or examination of the samples taken, are not valid as regards the remainder of the goods declared. The request shall be granted provided that the goods have not been released or, if they have been released, that the declarant proves that they have not been altered in any way. 2. For the purposes of paragraph 1, where a customs declaration covers goods falling under two or more items, the particulars relating to goods falling under each item shall be deemed to constitute a separate declaration. Article 191 Results of the verification 1. The results of verifying the customs declaration shall be used for the application of the provisions governing the customs procedure under which the goods are placed. 2. Where the customs declaration is not verified, paragraph 1 shall apply on the basis of the particulars contained in that declaration. 3. The results of the verification made by the customs authorities shall have the same conclusive force throughout the customs territory of the Union. Article 192 Identification measures 1. The customs authorities or, where appropriate, economic operators authorised to do so by the customs authorities, shall take the measures necessary to identify the goods where identification is required in order to ensure compliance with the provisions governing the customs procedure for which those goods have been declared. Those identification measures shall have the same legal effect throughout the customs territory of the Union. 2. Means of identification affixed to the goods, packaging or means of transport shall be removed or destroyed only by the customs authorities or, where they are authorised to do so by the customs authorities, by economic operators, unless, as a result of unforeseeable circumstances or force majeure, their removal or destruction is essential to ensure the protection of the goods or the means of transport. Article 193 Conferral of implementing powers The Commission shall specify, by means of implementing acts, measures on the verification of the customs declaration, the examination and sampling of goods and the results of the verification. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Release Article 194 Release of the goods 1. Where the conditions for placing the goods under the procedure concerned are fulfilled and provided that any restriction has been applied and the goods are not subject to any prohibition, the customs authorities shall release the goods as soon as the particulars in the customs declaration have been verified or are accepted without verification. The first subparagraph shall also apply where verification as referred to in Article 188 cannot be completed within a reasonable period of time and the goods are no longer required to be present for verification purposes. 2. All the goods covered by the same declaration shall be released at the same time. For the purposes of the first subparagraph, where a customs declaration covers goods falling under two or more items the particulars relating to goods falling under each item shall be deemed to constitute a separate customs declaration. Article 195 Release dependent upon payment of the amount of import or export duty corresponding to the customs debt or provision of a guarantee 1. Where the placing of goods under a customs procedure gives rise to a customs debt, the release of the goods shall be conditional upon the payment of the amount of import or export duty corresponding to the customs debt or the provision of a guarantee to cover that debt. However, without prejudice to the third subparagraph, the first subparagraph shall not apply to temporary admission with partial relief from import duty. Where, pursuant to the provisions governing the customs procedure for which the goods are declared, the customs authorities require the provision of a guarantee, those goods shall not be released for the customs procedure in question until such guarantee is provided. 2. In specific cases, the release of the goods shall not be conditional upon the provision of a guarantee in respect of goods which are the subject of a drawing request on a tariff quota. 3. Where a simplification as referred to in Articles 166, 182 and 185 is used and a comprehensive guarantee is provided, release of the goods shall not be conditional upon a monitoring of the guarantee by the customs authorities. Article 196 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the cases referred to in Article 195(2). CHAPTER 4 Disposal of goods Article 197 Destruction of goods Where the customs authorities have reasonable grounds for so doing, they may require goods which have been presented to customs to be destroyed and shall inform the holder of the goods accordingly. The costs of the destruction shall be borne by the holder of the goods. Article 198 Measures to be taken by the customs authorities 1. The customs authorities shall take any necessary measures, including confiscation and sale, or destruction, to dispose of goods in the following cases: (a) where one of the obligations laid down in the customs legislation concerning the introduction of non-Union goods into the customs territory of the Union has not been fulfilled, or the goods have been withheld from customs supervision; (b) where the goods cannot be released for any of the following reasons: (i) it has not been possible, for reasons attributable to the declarant, to undertake or continue examination of the goods within the period prescribed by the customs authorities; (ii) the documents which must be provided before the goods can be placed under, or released for, the customs procedure requested have not been provided; (iii) payments or a guarantee which should have been made or provided in respect of import or export duty, as the case may be, have not been made or provided within the prescribed period; (iv) the goods are subject to prohibitions or restrictions; (c) where the goods have not been removed within a reasonable period after their release; (d) where after their release, the goods are found not to have fulfilled the conditions for that release; or (e) where goods are abandoned to the State in accordance with Article 199. 2. Non-Union goods which have been abandoned to the State, seized or confiscated shall be deemed to be placed under the customs warehousing procedure. They shall be entered in the records of the customs warehousing operator, or, where they are held by the customs authorities, by the latter. Where goods to be destroyed, abandoned to the State, seized or confiscated are already subject to a customs declaration, the records shall include a reference to the customs declaration. Customs authorities shall invalidate that customs declaration. 3. The costs of the measures referred to in paragraph 1 shall be borne: (a) in the case referred to in point (a) of paragraph 1, by any person who was required to fulfil the obligations concerned or who withheld the goods from customs supervision; (b) in the cases referred to in points (b) and (c) of paragraph 1, by the declarant; (c) in the case referred to in point (d) of paragraph 1, by the person who is required to comply with the conditions governing the release of the goods; (d) in the case referred to in point (e) of paragraph 1, by the person who abandons the goods to the State. Article 199 Abandonment Non-Union goods and goods placed under the end-use procedure may with prior permission of the customs authorities be abandoned to the State by the holder of the procedure or, where applicable, the holder of the goods. Article 200 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules on: (a) the destruction of goods, referred to in Article 197; (b) the sale of goods, referred to in Article 198(1); (c) abandonment of goods to the State in accordance with Article 199. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). TITLE VI RELEASE FOR FREE CIRCULATION AND RELIEF FROM IMPORT DUTY CHAPTER 1 Release for free circulation Article 201 Scope and effect 1. Non-Union goods intended to be put on the Union market or intended for private use or consumption within the customs territory of the Union shall be placed under release for free circulation. 2. Release for free circulation shall entail the following: (a) the collection of any import duty due; (b) the collection, as appropriate, of other charges, as provided for under relevant provisions in force relating to the collection of those charges; (c) the application of commercial policy measures and prohibitions and restrictions insofar as they do not have to be applied at an earlier stage; and (d) completion of the other formalities laid down in respect of the import of the goods. 3. Release for free circulation shall confer on non-Union goods the customs status of Union goods. Article 202 Commercial policy measures 1. Where processed products obtained under inward processing are released for free circulation and the calculation of the amount of import duty is made in accordance with Article 86(3), the commercial policy measures to be applied shall be those applicable to the release for free circulation of the goods which were placed under inward processing. 2. Paragraph 1 shall not apply to waste and scrap. 3. Where processed products obtained under inward processing are released for free circulation and the calculation of the amount of import duty is made in accordance with Article 85(1), the commercial policy measures applicable to those goods shall be applied only where the goods which were placed under inward processing are subject to such measures. 4. Where Union legislation establishes commercial policy measures on release for free circulation, such measures shall not apply to processed products released for free circulation following outward processing where: (a) the processed products retain their Union origin within the meaning of Article 60; (b) the outward processing involves repair, including the standard exchange system referred to in Article 261; or (c) the outward processing follows further processing operations in accordance with Article 258. CHAPTER 2 Relief from import duty Section 1 Returned goods Article 203 Scope and effect 1. Non-Union goods which, having originally been exported as Union goods from the customs territory of the Union, are returned to that territory within a period of three years and declared for release for free circulation shall, upon application by the person concerned, be granted relief from import duty. The first subparagraph shall apply even where the returned goods represent only a part of the goods previously exported from the customs territory of the Union. 2. The three-year period referred to in paragraph 1 may be exceeded in order to take account of special circumstances. 3. Where, prior to their export from the customs territory of the Union, the returned goods had been released for free circulation duty-free or at a reduced rate of import duty because of a particular end-use, relief from duty under paragraph 1 shall be granted only if they are to be released for free circulation for the same end-use. Where the end-use for which the goods in question are to be released for free circulation is no longer the same, the amount of import duty shall be reduced by any amount collected on the goods when they were first released for free circulation. Should the latter amount exceed that levied on the release for free circulation of the returned goods, no repayment shall be granted. 4. Where Union goods have lost their customs status as Union goods pursuant to Article 154 and are subsequently released for free circulation, paragraphs 1, 2 and 3 shall apply. 5. The relief from import duty shall be granted only if goods are returned in the state in which they were exported. 6. The relief from import duty shall be supported by information establishing that the conditions for the relief are fulfilled. Article 204 Goods which benefited from measures laid down under the common agricultural policy Relief from import duty provided for in Article 203 shall not be granted to goods which have benefited from measures laid down under the common agricultural policy involving their export out of the customs territory of the Union, except where otherwise provided in specific cases. Article 205 Goods previously placed under the inward processing procedure 1. Article 203 shall apply to processed products which were originally re-exported from the customs territory of the Union subsequent to an inward processing procedure. 2. Upon application by the declarant and provided the declarant submits the necessary information, the amount of import duty on the goods covered by paragraph 1 shall be determined in accordance with Article 86(3). The date of acceptance of the re-export declaration shall be regarded as the date of release for free circulation. 3. The relief from import duty provided for in Article 203 shall not be granted for processed products which were exported in accordance with point (c) of Article 223(2), unless it is ensured that no goods will be placed under the inward processing procedure. Article 206 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the cases where goods are considered to be returned in the state in which they were exported; (b) the specific cases referred to in Article 204. Article 207 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for the provision of information referred to in Article 203(6). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Sea-fishing and products taken from the sea Article 208 Products of sea-fishing and other products taken from the sea 1. Without prejudice to Article 60(1), the following shall be granted relief from import duty when they are released for free circulation: (a) products of sea-fishing and other products taken from the territorial sea of a country or territory outside the customs territory of the Union by vessels solely registered or recorded in a Member State and flying the flag of that State; (b) products obtained from products referred to in point (a) on board factory-ships fulfilling the conditions laid down in that point. 2. The relief from import duty referred to in paragraph 1 shall be supported by evidence that the conditions laid down in that paragraph are fulfilled. Article 209 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for the provision of the evidence referred to in Article 208(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). TITLE VII SPECIAL PROCEDURES CHAPTER 1 General provisions Article 210 Scope Goods may be placed under any of the following categories of special procedures: (a) transit, which shall comprise external and internal transit; (b) storage, which shall comprise customs warehousing and free zones; (c) specific use, which shall comprise temporary admission and end-use; (d) processing, which shall comprise inward and outward processing. Article 211 Authorisation 1. An authorisation from the customs authorities shall be required for the following: (a) the use of the inward or outward processing procedure, the temporary admission procedure or the end-use procedure; (b) the operation of storage facilities for the customs warehousing of goods, except where the storage facility operator is the customs authority itself. The conditions under which the use of one or more of the procedures referred to in the first subparagraph or the operation of storage facilities is permitted shall be set out in the authorisation. 2. The customs authorities shall grant an authorisation with retroactive effect, where all of the following conditions are fulfilled: (a) there is a proven economic need; (b) the application is not related to attempted deception; (c) the applicant has proven on the basis of accounts or records that: (i) all the requirements of the procedure are met; (ii) where appropriate, the goods can be identified for the period involved; (iii) such accounts or records allow the procedure to be controlled; (d) all the formalities necessary to regularise the situation of the goods can be carried out, including, where necessary, the invalidation of the customs declarations concerned; (e) no authorisation with retroactive effect has been granted to the applicant within three years of the date on which the application was accepted; (f) an examination of the economic conditions is not required, except where an application concerns renewal of an authorisation for the same kind of operation and goods; (g) the application does not concern the operation of storage facilities for the customs warehousing of goods; (h) where an application concerns renewal of an authorisation for the same kind of operation and goods, the application is submitted within three years of expiry of the original authorisation. Customs authorities may grant an authorisation with retroactive effect also where the goods which were placed under a customs procedure are no longer available at the time when the application for such authorisation was accepted. 3. Except where otherwise provided, the authorisation referred to in paragraph 1 shall be granted only to persons who satisfy all of the following conditions: (a) they are established in the customs territory of the Union; (b) they provide the necessary assurance of the proper conduct of the operations; an authorised economic operator for customs simplifications shall be deemed to fulfil this condition, insofar as the activity pertaining to the special procedure concerned is taken into account in the authorisation referred to in point (a) of Article 38(2); (c) where a customs debt or other charges may be incurred for goods placed under a special procedure, they provide a guarantee in accordance with Article 89; (d) in the case of the temporary admission or inward processing procedure, they use the goods or arrange for their use or they carry out processing operations on the goods or arrange for them to be carried out, respectively. 4. Except where otherwise provided and in addition to paragraph 3, the authorisation referred to in paragraph 1 shall be granted only where all of the following conditions are fulfilled: (a) the customs authorities are able to exercise customs supervision without having to introduce administrative arrangements disproportionate to the economic needs involved; (b) the essential interests of Union producers would not be adversely affected by an authorisation for a processing procedure (economic conditions). 5. The essential interests of Union producers shall be deemed not to be adversely affected, as referred to in point (b) of paragraph 4, except where evidence to the contrary exists or where the economic conditions are deemed to be fulfilled. 6. Where evidence exists that the essential interests of Union producers are likely to be adversely affected, an examination of the economic conditions shall take place at Union level. Article 212 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the conditions for granting the authorisation for the procedures referred to in Article 211(1); (b) the exceptions to the conditions referred to in Article 211(3) and (4); (c) the cases in which the economic conditions are deemed to be fulfilled as referred to in Article 211(5). Article 213 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for examining the economic conditions referred to in Article 211(6). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 214 Records 1. Except for the transit procedure, or where otherwise provided, the holder of the authorisation, the holder of the procedure, and all persons carrying on an activity involving the storage, working or processing of goods, or the sale or purchase of goods in free zones, shall keep appropriate records in a form approved by the customs authorities. The records shall contain the information and the particulars which enable the customs authorities to supervise the procedure concerned, in particular with regard to identification of the goods placed under that procedure, their customs status and their movements. 2. An authorised economic operator for customs simplifications shall be deemed to comply with the obligation laid down in paragraph 1 insofar as his or her records are appropriate for the purpose of the special procedure concerned. Article 215 Discharge of a special procedure 1. In cases other than the transit procedure and without prejudice to Article 254, a special procedure shall be discharged when the goods placed under the procedure, or the processed products, are placed under a subsequent customs procedure, have been taken out of the customs territory of the Union, or have been destroyed with no waste remaining, or are abandoned to the State in accordance with Article 199. 2. The transit procedure shall be discharged by the customs authorities when they are in a position to establish, on the basis of a comparison of the data available to the customs office of departure and those available to the customs office of destination, that the procedure has ended correctly. 3. The customs authorities shall take all the measures necessary to regularise the situation of the goods in respect of which a procedure has not been discharged under the conditions prescribed. 4. The discharge of the procedure shall take place within a certain time-limit, unless otherwise provided. Article 216 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the time-limit referred to in Article 215(4). Article 217 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for the discharge of a special procedure, referred to in Article 216. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 218 Transfer of rights and obligations The rights and obligations of the holder of a procedure with regard to goods which have been placed under a special procedure other than transit may be fully or partially transferred to another person who fulfils the conditions laid down for the procedure concerned. Article 219 Movement of goods In specific cases, goods placed under a special procedure other than transit or in a free zone may be moved between different places in the customs territory of the Union. Article 220 Usual forms of handling Goods placed under customs warehousing or a processing procedure or in a free zone may undergo usual forms of handling intended to preserve them, improve their appearance or marketable quality or prepare them for distribution or resale. Article 221 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284: (a) laying down the cases and the conditions for the movement of goods placed under a special procedure other than transit or in a free zone in accordance with Article 219; (b) determining the usual forms of handling for goods placed under customs warehousing or a processing procedure or in a free zone as referred to in Article 220. Article 222 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) transferring the rights and obligations of the holder of the procedure with regard to goods which have been placed under a special procedure other than transit in accordance with Article 218; (b) the movement of goods placed under a special procedure other than transit or in a free zone in accordance with Article 219. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Article 223 Equivalent goods 1. Equivalent goods shall consist in Union goods which are stored, used or processed instead of the goods placed under a special procedure. Under the outward processing procedure, equivalent goods shall consist in non-Union goods which are processed instead of Union goods placed under the outward processing procedure. Except where otherwise provided, equivalent goods shall have the same eight-digit Combined Nomenclature code, the same commercial quality and the same technical characteristics as the goods which they are replacing. 2. The customs authorities shall, upon application, authorise the following, provided that the proper conduct of the procedure, in particular as regards customs supervision, is ensured: (a) the use of equivalent goods under customs warehousing, free zones, end-use and a processing procedure; (b) the use of equivalent goods under the temporary admission procedure, in specific cases; (c) in the case of the inward processing procedure, the export of processed products obtained from equivalent goods before the import of the goods they are replacing; (d) in the case of the outward processing procedure, the import of processed products obtained from equivalent goods before the export of the goods they are replacing. An authorised economic operator for customs simplifications shall be deemed to fulfil the condition that the proper conduct of the procedure is ensured, insofar as the activity pertaining to the use of equivalent goods for the procedure concerned is taken into account in the authorisation referred to in point (a) of Article 38(2). 3. The use of equivalent goods shall not be authorised in any of the following cases: (a) where only usual forms of handling as defined in Article 220 are carried out under the inward processing procedure; (b) where a prohibition of drawback of, or exemption from, import duty applies to non-originating goods used in the manufacture of processed products under the inward processing procedure, for which a proof of origin is issued or made out in the framework of a preferential arrangement between the Union and certain countries or territories outside the customs territory of the Union or groups of such countries or territories; (c) where it would lead to an unjustified import duty advantage or where provided for in Union legislation. 4. In the case referred to in point (c) of paragraph 2, and where the processed products would be liable to export duty if they were not being exported in the context of the inward processing procedure, the holder of the authorisation shall provide a guarantee to ensure payment of the export duty should the non-Union goods not be imported within the period referred to in Article 257(3). Article 224 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the exceptions from the third subparagraph of Article 223(1); (b) the conditions under which equivalent goods are used in accordance with Article 223(2); (c) the specific cases where equivalent goods are used under the temporary admission procedure, in accordance with point (b) of Article 223(2); (d) the cases where the use of equivalent goods is not authorised in accordance with point (c) of Article 223(3). Article 225 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for the use of equivalent goods authorised in accordance with Article 223(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 2 Transit Section 1 External and internal transit Article 226 External transit 1. Under the external transit procedure, non-Union goods may be moved from one point to another within the customs territory of the Union without being subject to any of the following: (a) import duty; (b) other charges as provided for under other relevant provisions in force; (c) commercial policy measures, insofar as they do not prohibit the entry or exit of goods into or from the customs territory of the Union. 2. In specific cases, Union goods shall be placed under the external transit procedure. 3. Movement as referred to in paragraph 1 shall take place in one of the following ways: (a) under the external Union transit procedure; (b) in accordance with the TIR Convention, provided that such movement: (i) began or is to end outside the customs territory of the Union; (ii) is effected between two points in the customs territory of the Union through the territory of a country or territory outside the customs territory of the Union; (c) in accordance with the ATA Convention/Istanbul Convention, where a transit movement takes place; (d) under cover of the Rhine Manifest (Article 9 of the Revised Convention for the Navigation of the Rhine); (e) under cover of form 302 provided for in the Agreement between the Parties to the North Atlantic Treaty regarding the Status of their Forces, signed in London on 19 June 1951; (f) under the postal system in accordance with the acts of the Universal Postal Union, when the goods are carried by or for holders of rights and obligations under such acts. Article 227 Internal transit 1. Under the internal transit procedure, and under the conditions laid down in paragraph 2, Union goods may be moved from one point to another within the customs territory of the Union, and pass through a country or territory outside that customs territory, without any change in their customs status. 2. The movement referred to in paragraph 1 shall take place in one of the following ways: (a) under the internal Union transit procedure provided that such a possibility is provided for in an international agreement; (b) in accordance with the TIR Convention; (c) in accordance with the ATA Convention/Istanbul Convention, where a transit movement takes place; (d) under cover of the Rhine Manifest (Article 9 of the Revised Convention for the Navigation of the Rhine); (e) under cover of form 302 as provided for in the Agreement between the Parties to the North Atlantic Treaty regarding the Status of their Forces, signed in London on 19 June 1951; (f) under the postal system in accordance with the acts of the Universal Postal Union, when the goods are carried by or for holders of rights and obligations under such acts. Article 228 Single territory for transit purposes Where goods are moved from one point in the customs territory of the Union to another in accordance with the TIR Convention, the ATA Convention / Istanbul Convention, under cover of form 302 or under the postal system, the customs territory of the Union shall, for the purposes of such transport, be considered to form a single territory. Article 229 Exclusion of persons from TIR operations 1. Where the customs authorities of a Member State decide to exclude a person from TIR operations under Article 38 of the TIR Convention, that decision shall apply throughout the customs territory of the Union and TIR carnets lodged by that person shall not be accepted by any customs office. 2. A Member State shall communicate its decision referred to in paragraph 1, together with the date of its application, to the other Member States and to the Commission. Article 230 Authorised consignee for TIR purposes The customs authorities may, upon application, authorise a person, referred to as an 'authorised consignee' to receive goods moved in accordance with the TIR Convention at an authorised place, so that the procedure is terminated in accordance with point (d) of Article 1 of the TIR Convention. Article 231 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the specific cases where Union goods are to be placed under the external transit procedure in accordance with Article 226(2); (b) the conditions for the granting of the authorisation referred to in Article 230. Article 232 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules to apply points (b) to (f) of Article 226(3) and points (b) to (f) of Article 227(2) in the customs territory of the Union, taking into account the needs of the Union. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Union transit Article 233 Obligations of the holder of the Union transit procedure and of the carrier and recipient of goods moving under the Union transit procedure 1. The holder of the Union transit procedure shall be responsible for all of the following: (a) presentation of the goods intact and the required information at the customs office of destination within the prescribed time-limit and in compliance with the measures taken by the customs authorities to ensure their identification; (b) observance of the customs provisions relating to the procedure; (c) unless otherwise provided for in the customs legislation, provision of a guarantee in order to ensure payment of the amount of import or export duty corresponding to any customs debt or other charges, as provided for under other relevant provisions in force, which may be incurred in respect of the goods. 2. The obligation of the holder of the procedure shall be met and the transit procedure shall end when the goods placed under the procedure and the required information are available at the customs office of destination in accordance with the customs legislation. 3. A carrier or recipient of goods who accepts goods knowing that they are moving under the Union transit procedure shall also be responsible for presentation of the goods intact at the customs office of destination within the prescribed time-limit and in compliance with the measures taken by the customs authorities to ensure their identification. 4. Upon application, the customs authorities may authorise any of the following simplifications regarding the placing of goods under the Union transit procedure or the end of that procedure: (a) the status of authorised consignor, allowing the holder of the authorisation to place goods under the Union transit procedure without presenting them to customs; (b) the status of authorised consignee, allowing the holder of the authorisation to receive goods moved under the Union transit procedure at an authorised place, to end the procedure in accordance with Article 233(2); (c) the use of seals of a special type, where sealing is required to ensure the identification of the goods placed under the Union transit procedure; (d) the use of a customs declaration with reduced data requirements to place goods under the Union transit procedure; (e) the use of an electronic transport document as customs declaration to place goods under the Union transit procedure, provided it contains the particulars of such declaration and those particulars are available to the customs authorities at departure and at destination to allow the customs supervision of the goods and the discharge of the procedure. Article 234 Goods passing through the territory of a country or territory outside the customs territory of the Union under the external Union transit procedure 1. The external Union transit procedure shall apply to goods passing through a country or a territory outside the customs territory of the Union if one of the following conditions is fulfilled: (a) provision is made to that effect under an international agreement; (b) carriage through that country or territory is effected under cover of a single transport document drawn up in the customs territory of the Union. 2. In the case referred to in point (b) of paragraph 1, the operation of the external Union transit procedure shall be suspended while the goods are outside the customs territory of the Union. Article 235 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine the conditions for granting the authorisations referred to in Article 233(4). Article 236 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules on: (a) the placing of goods under the Union transit procedure and the end of that procedure; (b) the operation of the simplifications referred to in Article 233(4); (c) the customs supervision of goods passing through the territory of a country or territory outside the customs territory of the Union under the external Union transit procedure, referred to in Article 234. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 3 Storage Section 1 Common provisions Article 237 Scope 1. Under a storage procedure, non-Union goods may be stored in the customs territory of the Union without being subject to any of the following: (a) import duty; (b) other charges as provided for under other relevant provisions in force; (c) commercial policy measures, insofar as they do not prohibit the entry or exit of goods into or from the customs territory of the Union. 2. Union goods may be placed under the customs warehousing or free zone procedure in accordance with Union legislation governing specific fields, or in order to benefit from a decision granting repayment or remission of import duty. 3. The customs authorities may, where an economic need exists and customs supervision will not be adversely affected, authorise the storage of Union goods in a storage facility for customs warehousing. Those goods shall not be regarded as being under the customs warehousing procedure. Article 238 Duration of a storage procedure 1. There shall be no limit to the length of time goods may remain under a storage procedure. 2. In exceptional circumstances, the customs authorities may set a time-limit by which a storage procedure must be discharged in particular where the type and nature of the goods may, in the case of long-term storage, pose a threat to human, animal or plant health or to the environment. Article 239 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for the placing of Union goods under the customs warehousing or free zone procedure as referred to in Article 237(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Section 2 Customs warehousing Article 240 Storage in customs warehouses 1. Under the customs warehousing procedure non-Union goods may be stored in premises or any other location authorised for that procedure by the customs authorities and under customs supervision ('customs warehouses'). 2. Customs warehouses may be available for use by any person for the customs warehousing of goods ('public customs warehouse'), or for the storage of goods by the holder of an authorisation for customs warehousing ('private customs warehouse'). 3. Goods placed under the customs warehousing procedure may be temporarily removed from the customs warehouse. Such removal shall, except in case of force majeure, be authorised in advance by the customs authorities. Article 241 Processing 1. The customs authorities may, where an economic need exists and customs supervision is not adversely affected, authorise the processing of goods under the inward processing or end-use procedure to take place in a customs warehouse, subject to the conditions provided for by those procedures. 2 The goods referred to in paragraph 1 shall not be regarded as being under the customs warehousing procedure. Article 242 Responsibilities of the holder of the authorisation or procedure 1. The holder of the authorisation and the holder of the procedure shall be responsible for the following: (a) ensuring that goods under the customs warehousing procedure are not removed from customs supervision; and (b) fulfilling the obligations arising from the storage of goods covered by the customs warehousing procedure. 2. By way of derogation from paragraph 1, where the authorisation concerns a public customs warehouse, it may provide that the responsibilities referred to in points (a) or (b) of paragraph 1 devolve exclusively upon the holder of the procedure. 3. The holder of the procedure shall be responsible for fulfilling the obligations arising from the placing of the goods under the customs warehousing procedure. Section 3 Free zones Article 243 Designation of free zones 1. Member States may designate parts of the customs territory of the Union as free zones. For each free zone the Member State shall determine the area covered and define the entry and exit points. 2. Member States shall communicate to the Commission information on their free zones which are in operation. 3. Free zones shall be enclosed. The perimeter and the entry and exit points of the area of free zones shall be subject to customs supervision. 4. Persons, goods and means of transport entering or leaving free zones may be subject to customs controls. Article 244 Buildings and activities in free zones 1. The construction of any building in a free zone shall require the prior approval of the customs authorities. 2. Subject to the customs legislation, any industrial, commercial or service activity shall be permitted in a free zone. The carrying on of such activities shall be subject to notification, in advance, to the customs authorities. 3. The customs authorities may impose prohibitions or restrictions on the activities referred to in paragraph 2, having regard to the nature of the goods in question, or the requirements of customs supervision, or security and safety requirements. 4. The customs authorities may prohibit persons who do not provide the necessary assurance of compliance with the customs provisions from carrying on an activity in a free zone. Article 245 Presentation of goods and their placing under the procedure 1. Goods brought into a free zone shall be presented to customs and undergo the prescribed customs formalities in any of the following cases: (a) where they are brought into the free zone directly from outside the customs territory of the Union; (b) where they have been placed under a customs procedure which is ended or discharged when they are placed under the free zone procedure; (c) where they are placed under the free zone procedure in order to benefit from a decision granting repayment or remission of import duty; (d) where legislation other than the customs legislation provides for such formalities. 2. Goods brought into a free zone in circumstances other than those covered by paragraph 1 shall not be presented to customs. 3. Without prejudice to Article 246, goods brought into a free zone are deemed to be placed under the free zone procedure: (a) at the moment of their entry into a free zone, unless they have already been placed under another customs procedure; or (b) at the moment when a transit procedure is ended, unless they are immediately placed under a subsequent customs procedure. Article 246 Union goods in free zones 1. Union goods may be entered, stored, moved, used, processed or consumed in a free zone. In such cases the goods shall not be regarded as being under the free zone procedure. 2. Upon application by the person concerned, the customs authorities shall establish the customs status as Union goods of any of the following goods: (a) Union goods which enter a free zone; (b) Union goods which have undergone processing operations within a free zone; (c) goods released for free circulation within a free zone. Article 247 Non-Union goods in free zones 1. Non-Union goods may, while they remain in a free zone, be released for free circulation or be placed under the inward processing, temporary admission or end-use procedure, under the conditions laid down for those procedures. In such cases the goods shall not be regarded as being under the free zone procedure. 2. Without prejudice to the provisions applicable to supplies or to victualling storage, where the procedure concerned so provides, paragraph 1 shall not preclude the use or consumption of goods of which the release for free circulation or temporary admission would not entail application of import duty or measures laid down under the common agricultural or commercial policies. In the case of such use or consumption, no customs declaration for the release for free circulation or temporary admission procedure shall be required. Such declaration shall, however, be required if such goods are subject to a tariff quota or ceiling. Article 248 Taking goods out of a free zone 1. Without prejudice to legislation in fields other than customs, goods in a free zone may be exported or re-exported from the customs territory of the Union, or brought into another part of the customs territory of the Union. 2. Articles 134 to 149 shall apply to goods taken out of a free zone into other parts of the customs territory of the Union. Article 249 Customs status Where goods are taken out of a free zone into another part of the customs territory of the Union or placed under a customs procedure, they shall be regarded as non-Union goods unless their customs status as Union goods has been proven. However, for the purposes of applying export duty and export licences or export control measures laid down under the common agricultural or commercial policies, such goods shall be regarded as Union goods, unless it is established that they do not have the customs status of Union goods. CHAPTER 4 Specific use Section 1 Temporary admission Article 250 Scope 1. Under the temporary admission procedure non-Union goods intended for re-export may be subject to specific use in the customs territory of the Union, with total or partial relief from import duty, and without being subject to any of the following: (a) other charges as provided for under other relevant provisions in force; (b) commercial policy measures, insofar as they do not prohibit the entry or exit of goods into or from the customs territory of the Union. 2. The temporary admission procedure may only be used provided that the following conditions are met: (a) the goods are not intended to undergo any change, except normal depreciation due to the use made of them; (b) it is possible to ensure that the goods placed under the procedure can be identified, except where, in view of the nature of the goods or of the intended use, the absence of identification measures is not liable to give rise to any abuse of the procedure or, in the case referred to in Article 223, where compliance with the conditions laid down in respect of equivalent goods can be verified; (c) the holder of the procedure is established outside the customs territory of the Union, except where otherwise provided; (d) the requirements for total or partial duty relief laid down in the customs legislation are met. Article 251 Period during which goods may remain under the temporary admission procedure 1. The customs authorities shall determine the period within which goods placed under the temporary admission procedure must be re-exported or placed under a subsequent customs procedure. Such period shall be long enough for the objective of authorised use to be achieved. 2. Except where otherwise provided, the maximum period during which goods may remain under the temporary admission procedure for the same purpose and under the responsibility of the same authorisation holder shall be 24 months, even where the procedure was discharged by placing the goods under another special procedure and subsequently placing them under the temporary admission procedure again. 3. Where, in exceptional circumstances, the authorised use cannot be achieved within the period referred to in paragraphs 1 and 2, the customs authorities may grant an extension, of reasonable duration of that period, upon justified application by the holder of the authorisation. 4. The overall period during which goods may remain under the temporary admission procedure shall not exceed 10 years, except in the case of an unforeseeable event. Article 252 Amount of import duty in case of temporary admission with partial relief from import duty 1. The amount of import duty in respect of goods placed under the temporary admission procedure with partial relief from import duty shall be set at 3 % of the amount of import duty which would have been payable on those goods had they been released for free circulation on the date on which they were placed under the temporary admission procedure. That amount shall be payable for every month or fraction of a month during which the goods have been placed under the temporary admission procedure with partial relief from import duty. 2. The amount of import duty shall not exceed that which would have been payable if the goods in question had been released for free circulation on the date on which they were placed under the temporary admission procedure. Article 253 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 243, in order to determine: (a) the specific use referred to in Article 250(1); (b) the requirements referred to in point (d) of Article 250(2). Section 2 End-use Article 254 End-use procedure 1. Under the end-use procedure, goods may be released for free circulation under a duty exemption or at a reduced rate of duty on account of their specific use. 2. Where the goods are at a production stage which would allow economically the prescribed end-use only, the customs authorities may establish in the authorisation the conditions under which the goods shall be deemed to have been used for the purposes laid down for applying the duty exemption or reduced rate of duty. 3. Where goods are suitable for repeated use and the customs authorities consider it appropriate in order to avoid abuse, customs supervision shall continue for a period not exceeding two years after the date of their first use for the purposes laid down for applying the duty exemption or reduced rate of duty. 4. Customs supervision under the end-use procedure shall end in any of the following cases: (a) where the goods have been used for the purposes laid down for the application of the duty exemption or reduced rate of duty; (b) where the goods have been taken out of the customs territory of the Union, destroyed or abandoned to the State; (c) where the goods have been used for purposes other than those laid down for the application of the duty exemption or reduced duty rate and the applicable import duty has been paid. 5. Where a rate of yield is required, Article 255 shall apply to the end-use procedure. 6. Waste and scrap which result from the working or processing of goods according to the prescribed end-use and losses due to natural wastage shall be considered as goods assigned to the prescribed end-use. 7. Waste and scrap resulting from the destruction of goods placed under the end-use procedure shall be deemed to be placed under the customs warehousing procedure. CHAPTER 5 Processing Section 1 General provisions Article 255 Rate of yield Except where a rate of yield has been specified in Union legislation governing specific fields, the customs authorities shall set either the rate of yield or average rate of yield of the processing operation or where appropriate, the method of determining such rate. The rate of yield or average rate of yield shall be determined on the basis of the actual circumstances in which processing operations are, or are to be, carried out. That rate may be adjusted, where appropriate, in accordance with Article 28. Section 2 Inward processing Article 256 Scope 1. Without prejudice to Article 223, under the inward processing procedure non-Union goods may be used in the customs territory of the Union in one or more processing operations without such goods being subject to any of the following: (a) import duty; (b) other charges as provided for under other relevant provisions in force; (c) commercial policy measures, insofar as they do not prohibit the entry or exit of goods into or from the customs territory of the Union. 2. The inward processing procedure may be used in cases other than repair and destruction only where, without prejudice to the use of production accessories, the goods placed under the procedure can be identified in the processed products. In the case referred to in Article 223, the procedure may be used where compliance with the conditions laid down in respect of equivalent goods can be verified. 3. In addition to paragraphs 1 and 2, the inward processing procedure may also be used for any of the following goods: (a) goods intended to undergo operations to ensure their compliance with technical requirements for their release for free circulation; (b) goods which have to undergo usual forms of handling in accordance with Article 220. Article 257 Period for discharge 1. The customs authorities shall specify the period within which the inward processing procedure is to be discharged, in accordance with Article 216. That period shall run from the date on which the non-Union goods are placed under the procedure and shall take account of the time required to carry out the processing operations and to discharge the procedure. 2. The customs authorities may grant an extension, of reasonable duration, of the period specified pursuant to paragraph 1, upon justified application by the holder of the authorisation. The authorisation may specify that a period which commences in the course of a month, quarter or semester shall end on the last day of a subsequent month, quarter or semester respectively. 3. In the case of prior export in accordance with point (c) of Article 223(2), the authorisation shall specify the period within which the non-Union goods shall be declared for the inward processing procedure, taking account of the time required for procurement and transport to the customs territory of the Union. The period referred to in the first subparagraph shall be set in months and shall not exceed six months. It shall run from the date of acceptance of the export declaration relating to the processed products obtained from the corresponding equivalent goods. 4. At the request of the holder of the authorisation, the period of six months referred to in paragraph 3 may be extended, even after its expiry, provided that the total period does not exceed 12 months. Article 258 Temporary re-export for further processing Upon application, the customs authorities may authorise some or all of the goods placed under the inward -processing procedure, or the processed products, to be temporarily re-exported for the purpose of further processing outside the customs territory of the Union, in accordance with the conditions laid down for the outward processing procedure. Section 3 Outward processing Article 259 Scope 1. Under the outward processing procedure Union goods may be temporarily exported from the customs territory of the Union in order to undergo processing operations. The processed products resulting from those goods may be released for free circulation with total or partial relief from import duty upon application by the holder of the authorisation or any other person established in the customs territory of the Union provided that that person has obtained the consent of the holder of the authorisation and the conditions of the authorisation are fulfilled. 2. Outward processing shall not be allowed for any of the following Union goods: (a) goods the export of which gives rise to repayment or remission of import duty; (b) goods which, prior to export, were released for free circulation under a duty exemption or at a reduced rate of duty by virtue of their end-use, for as long as the purposes of such end-use have not been fulfilled, unless those goods have to undergo repair operations; (c) goods the export of which gives rise to the granting of export refunds; (d) goods in respect of which a financial advantage other than refunds referred to in point (c) is granted under the common agricultural policy by virtue of the export of those goods. 3. The customs authorities shall specify the period within which goods temporarily exported must be re-imported into the customs territory of the Union in the form of processed products, and released for free circulation, in order to be able to benefit from total or partial relief from import duty. They may grant an extension, of reasonable duration, of that period, upon justified application by the holder of the authorisation. Article 260 Goods repaired free of charge 1. Where it is established to the satisfaction of the customs authorities that goods have been repaired free of charge, either because of a contractual or statutory obligation arising from a guarantee or because of a manufacturing or material defect, they shall be granted total relief from import duty. 2. Paragraph 1 shall not apply where account was taken of the manufacturing or material defect at the time when the goods in question were first released for free circulation. Article 261 Standard exchange system 1. Under the standard exchange system an imported product ('replacement product') may, in accordance with paragraphs 2 to 5, replace a processed product. 2. The customs authorities shall, upon application authorise the standard exchange system to be used where the processing operation involves the repair of defective Union goods other than those subject to measures laid down under the common agricultural policy or to the specific arrangements applicable to certain goods resulting from the processing of agricultural products. 3. Replacement products shall have the same eight-digit Combined Nomenclature code, the same commercial quality and the same technical characteristics as the defective goods had the latter undergone repair. 4. Where the defective goods have been used before export, the replacement products must also have been used. The customs authorities shall, however, waive the requirement set out in the first subparagraph if the replacement product has been supplied free of charge, either because of a contractual or statutory obligation arising from a guarantee or because of a material or manufacturing defect. 5. The provisions which would be applicable to the processed products shall apply to the replacement products. Article 262 Prior import of replacement products 1. The customs authorities shall, under the conditions they lay down, upon application by the person concerned, authorise replacement products to be imported before the defective goods are exported. In the event of such prior import of a replacement product, a guarantee shall be provided, covering the amount of the import duty that would be payable should the defective goods not be exported in accordance with paragraph 2. 2. The defective goods shall be exported within a period of two months from the date of acceptance by the customs authorities of the declaration for the release for free circulation of the replacement products. 3. Where, in exceptional circumstances, the defective goods cannot be exported within the period referred to in paragraph 2, the customs authorities may grant an extension, of a reasonable duration, of that period, upon justified application by the holder of the authorisation. TITLE VIII GOODS TAKEN OUT OF THE CUSTOMS TERRITORY OF THE UNION CHAPTER 1 Formalities prior to the exit of goods Article 263 Lodging a pre-departure declaration 1. Goods to be taken out of the customs territory of the Union shall be covered by a pre-departure declaration to be lodged at the competent customs office within a specific time-limit before the goods are taken out of the customs territory of the Union. 2. The obligation referred to in paragraph 1 shall be waived: (a) for means of transport and the goods carried thereon only passing through the territorial waters or the airspace of the customs territory of the Union without a stop within that territory; or (b) in other specific cases, where duly justified by the type of goods or traffic or where required by international agreements. 3. The pre-departure declaration shall take the form of one of the following: (a) a customs declaration, where the goods to be taken out of the customs territory of the Union are placed under a customs procedure for which such declaration is required; (b) a re-export declaration, in accordance with Article 270; (c) an exit summary declaration, in accordance with Article 271. 4. The pre-departure declaration shall contain the particulars necessary for risk analysis for security and safety purposes. Article 264 Risk analysis The customs office to which the pre-departure declaration referred to in Article 263 is lodged shall ensure that, within a specific time-limit, a risk analysis is carried out, primarily for security and safety purposes, on the basis of that declaration and shall take the necessary measures based on the results of that risk analysis. Article 265 Delegation of power The Commission shall be empowered to adopt delegated acts, in accordance with Article 284, in order to determine: (a) the specific time-limit, referred to in Article 263(1), within which the pre-departure declaration is to be lodged before the goods are taken out of the customs territory of the Union taking into account the type of traffic; (b) the specific cases where the obligation to lodge a pre-departure declaration is waived in accordance with point (c) of Article 263(2). Article 266 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the time-limit referred to in Article 264, within which risk analysis is to be carried out taking into account the time-limit referred to in Article 263(1). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 2 Formalities on exit of goods Article 267 Customs supervision and formalities on exit 1. Goods to be taken out of the customs territory of the Union shall be subject to customs supervision and may be subject to customs controls. Where appropriate, the customs authorities may determine the route to be used, and the time-limit to be respected when goods are to be taken out of the customs territory of the Union. 2. Goods to be taken out of the customs territory of the Union shall be presented to customs on exit by one of the following persons: (a) the person who takes the goods out of the customs territory of the Union; (b) the person in whose name or on whose behalf the person who takes the goods out of the customs territory of the Union acts; (c) the person who assumes responsibility for the carriage of the goods prior to their exit from the customs territory of the Union. 3. Goods to be taken out of the customs territory of the Union shall be subject, as appropriate, to the following: (a) the repayment or remission of import duty; (b) the payment of export refunds; (c) the collection of export duty; (d) the formalities required under provisions in force with regard to other charges; (e) the application of prohibitions and restrictions justified on grounds of, inter alia, public morality, public policy or public security, the protection of the health and life of humans, animals or plants, the protection of the environment, the protection of national treasures possessing artistic, historic or archaeological value and the protection of industrial or commercial property, including controls against drug precursors, goods infringing certain intellectual property rights and cash, as well as the implementation of fishery conservation and management measures and of commercial policy measures. 4. Release for exit shall be granted by the customs authorities on condition that the goods in question will be taken out of the customs territory of the Union in the same condition as when: (a) the customs or re-export declaration was accepted; or (b) the exit summary declaration was lodged. Article 268 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules on the exit referred to in Article 267. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 3 Export and re-export Article 269 Export of Union goods 1. Union goods to be taken out of the customs territory of the Union shall be placed under the export procedure. 2. Paragraph 1 shall not apply to any of the following Union goods: (a) goods placed under the outward processing procedure; (b) goods taken out of the customs territory of the Union after having been placed under the end-use procedure; (c) goods delivered, VAT or excise duty exempted, as aircraft or ship supplies, regardless of the destination of the aircraft or ship, for which a proof of such supply is required; (d) goods placed under the internal transit procedure; (e) goods moved temporarily out of the customs territory of the Union in accordance with Article 155. 3. The formalities concerning the export customs declaration laid down in the customs legislation shall apply in the cases referred to in points (a), (b) and (c) of paragraph 2. Article 270 Re-export of non-Union goods 1. Non-Union goods to be taken out of the customs territory of the Union shall be subject to a re-export declaration to be lodged at the competent customs office. 2. Articles 158 to 195 shall apply to the re-export declaration. 3. Paragraph 1 shall not apply to any of the following goods: (a) goods placed under the external transit procedure which only pass through the customs territory of the Union; (b) goods trans-shipped within, or directly re-exported from, a free zone; (c) goods in temporary storage which are directly re-exported from a temporary storage facility. CHAPTER 4 Exit summary declaration Article 271 Lodging an exit summary declaration 1. Where goods are to be taken out of the customs territory of the Union and a customs declaration or a re-export declaration is not lodged as pre-departure declaration, an exit summary declaration shall be lodged at the customs office of exit. Customs authorities may allow the exit summary declaration to be lodged at another customs office, provided that the latter immediately communicates or makes available electronically the necessary particulars to the customs office of exit. 2. The exit summary declaration shall be lodged by the carrier. Notwithstanding the obligations of the carrier, the exit summary declaration may be lodged instead by one of the following persons: (a) the exporter or consignor or other person in whose name or on whose behalf the carrier acts; (b) any person who is able to present the goods in question or have them presented at the customs office of exit. 3. Customs authorities may accept that commercial, port or transport information systems may be used to lodge an exit summary declaration, provided that they contain the necessary particulars for such declaration and that these particulars are available within a specific time-limit, before the goods are taken out of the customs territory of the Union. 4. Customs authorities may accept, instead of the lodging of the exit summary declaration, the lodging of a notification and access to the particulars of an exit summary declaration in the economic operator's computer system. Article 272 Amendment and invalidation of the exit summary declaration 1. The declarant may, upon application, be permitted to amend one or more particulars of the exit summary declaration after it has been lodged. No amendment shall be possible after any of the following: (a) the customs authorities have informed the person who lodged the exit summary declaration that they intend to examine the goods; (b) the customs authorities have established that one or more particulars of the exit summary declaration are inaccurate or incomplete; (c) the customs authorities have already granted the release of the goods for exit. 2. Where the goods for which an exit summary declaration has been lodged are not taken out of the customs territory of the Union, the customs authorities shall invalidate that declaration in either of the following cases: (a) upon application by the declarant; (b) within 150 days after the lodging of the declaration. Article 273 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) lodging the exit summary declaration referred to in Article 271; (b) amending the exit summary declaration, in accordance with the first subparagraph of Article 272(1); (c) invalidating the exit summary declaration, in accordance with Article 272(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 5 Re-export notification Article 274 Lodging a re-export notification 1. Where non-Union goods referred to in points (b) and (c) of Article 270(3) are taken out of the customs territory of the Union and the obligation to lodge an exit summary declaration for those goods is waived, a re-export notification shall be lodged. 2. The re-export notification shall be lodged at the customs office of exit of the goods by the person responsible for the presentation of goods on exit in accordance with Article 267(2). 3. The re-export notification shall contain the particulars necessary to discharge the free zone procedure or to end the temporary storage. Customs authorities may accept that commercial, port or transport information systems may be used to lodge a re-export notification, provided that they contain the necessary particulars for such notification and these particulars are available before the goods are taken out of the customs territory of the Union. 4. Customs authorities may accept, instead of the lodging of the re-export notification, the lodging of a notification and access to the particulars of a re-export notification in the economic operator's computer system. Article 275 Amendment and invalidation of the re-export notification 1. The declarant may, upon application, be permitted to amend one or more particulars of the re-export notification after it has been lodged. No amendment shall be possible after any of the following: (a) the customs authorities have informed the person who lodged the re-export notification that they intend to examine the goods; (b) the customs authorities have established that one or more particulars of the re-export notification are inaccurate or incomplete; (c) the customs authorities have already granted the release of the goods for exit. 2. Where the goods for which a re-export notification has been lodged are not taken out of the customs territory of the Union, the customs authorities shall invalidate that notification in either of the following cases: (a) upon application by the declarant; (b) within 150 days after the lodging of the notification. Article 276 Conferral of implementing powers The Commission shall specify, by means of implementing acts, the procedural rules for: (a) lodging the re-export notification referred to in Article 274; (b) amending the re-export notification, in accordance with the first sub-paragraph of Article 275(1); (c) invalidating the re-export notification in accordance with Article 275(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 6 Relief from export duty Article 277 Relief from export duty for Union goods temporarily exported Without prejudice to Article 259, Union goods which are temporarily exported from the customs territory of the Union shall benefit from export duty relief, conditional upon their re-import. TITLE IX ELECTRONIC SYSTEMS, SIMPLIFICATIONS, DELEGATION OF POWER, COMMITTEE PROCEDURE AND FINAL PROVISIONS CHAPTER 1 Development of electronic systems Article 278 Transitional measures Means for the exchange and storage of information, other than the electronic data-processing techniques referred to in Article 6(1), may be used on a transitional basis, until 31 December 2020 at the latest, where the electronic systems which are necessary for the application of the provisions of the Code are not yet operational. Article 279 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 284 specifying the rules on the exchange and storage of data in the situation referred to in Article 278. Article 280 Work programme 1. In order to support the development of the electronic systems referred to in Article 278 and govern the setting up of transitional periods, the Commission shall, by 1 May 2014, draw up a work programme relating to the development and deployment of the electronic systems referred to in Article 16(1). 2. The work programme referred to in paragraph 1 shall have the following priorities: (a) the harmonised exchange of information on the basis of internationally accepted data models and message formats; (b) the reengineering of customs and customs related processes in view of enhancing their efficiency, effectiveness and uniform application and reducing compliance costs; and (c) the offering to economic operators of a wide range of electronic customs services, enabling them to interact in the same way with the customs authorities of any Member State. 3. The work programme referred to in paragraph 1 shall be updated regularly. Article 281 Conferral of implementing powers The Commission shall adopt, by means of implementing acts, the work programme referred to in Article 280. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). Where the committee delivers no opinion, the Commission shall not adopt the implementing acts referred to in paragraph 1 and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. CHAPTER 2 Simplifications in the application of the customs legislation Article 282 Tests The Commission may authorise one or more Member States, upon application, to test for a limited period of time simplifications in the application of the customs legislation, especially when IT-related. The test shall not affect the application of the customs legislation in those Member States that are not participating in such test and shall be evaluated periodically. Article 283 Conferral of implementing powers The Commission shall adopt, by means of implementing act, the decisions referred to in Article 282. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 285(4). CHAPTER 3 Delegation of power and committee procedure Article 284 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 2, 7, 10, 20, 24, 31, 36, 40, 62, 65, 75, 88, 99, 106, 115, 122, 126, 131, 142, 151, 156, 160, 164, 168, 175, 180, 183, 186, 196, 206, 212, 213, 221, 224, 231, 235, 253, 265, and 279 shall be conferred on the Commission for a period of five years from 30 October 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 2, 7, 10, 20, 24, 31, 36, 40, 62, 65, 75, 88, 99, 106, 115, 122, 126, 131, 142, 151, 156, 160, 164, 168, 175, 180, 183, 186, 196, 206, 212, 213, 221, 224, 231, 235, 253, 265, and 279 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 2, 7, 10, 20, 24, 31, 36, 40, 62, 65, 75, 88, 99, 106, 115, 122, 126, 131, 142, 151, 156, 160, 164, 168, 175, 180, 183, 186, 196, 206, 212, 213, 221, 224, 231, 235, 253, 265, or 279 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 285 Committee procedure 1. The Commission shall be assisted by the Customs Code Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011 in conjunction with Article 4 thereof shall apply. 4. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 5. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011 in conjunction with Article 5 thereof shall apply. 6. Where the opinion of the committee is to be obtained by written procedure and reference is made to this paragraph, that procedure shall be terminated without result only when, within the time-limit for delivery of the opinion, the chair of the committee so decides. CHAPTER 4 Final provisions Article 286 Repeal and amendment of legislation in force 1. Regulation (EC) No 450/2008 is repealed. 2. Regulation (EEC) No 3925/91, Regulation (EEC) No 2913/92 and Regulation (EC) No 1207/2001 are repealed from the date referred to in Article 288(2). 3. References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation tables set out in the Annex. 4. In the sixth indent of Article 3(1) of Regulation (EEC) No 2913/92, the phrase 'and Mayotte' is deleted as from 1 January 2014. 5. The first indent of point (a) of Article 9(1) of Regulation (EEC) No 2658/87 is deleted from the date referred to in Article 288(2). Article 287 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 288 Application 1. Articles 2, 7, 8, 10, 11, 17, 20, 21, 24, 25, 31, 32, 36, 37, 40, 41, 50, 52, 54, 58, 62, 63, 65, 66, 68, 75, 76, 88, 99, 100, 106, 107, 115, 122, 123, 126, 131, 132, 138, 142, 143, 151, 152, 156, 157, 160, 161, 164, 165, 168, 169, 175, 176, 178, 180, 181, 183, 184, 186, 187, 193, 196, 200, 206, 207, 209, 212, 213, 216, 217, 221, 222, 224, 225, 231, 232, 235, 236, 239, 253, 265, 266, 268, 273, 276, 279, 280, 281, 283, 284, 285 and 286 shall apply as from 30 October 2013. 2. Articles other than those referred to in paragraph 1 shall apply as from 1 June 2016. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 9 October 2013. For the European Parliament The President M. SCHULZ For the Council The President V. LEŠKEVIČIUS (1) OJ C 229, 31.7.2012, p. 68. (2) Position of the European Parliament of 11 September 2013 (not yet published in the Official Journal) and decision of the Council of 27 September 2013. (3) OJ L 145, 4.6.2008, p. 1. (4) OJ L 55, 28.2.2011, p. 13. (5) OJ L 302, 19.10.1992, p. 1. (6) OJ L 117, 4.5.2005, p. 13. (7) OJ L 86, 3.4.2003, p. 21. (8) OJ L 347, 11.12.2006, p. 1. (9) OJ L 9, 14.1.2009, p. 12. (10) OJ L 23, 26.1.2008, p. 21. (11) OJ L 374, 31.12.1991, p. 4. (12) OJ L 165, 21.6.2001, p. 1. (13) OJ L 256, 7.9.1987, p. 1. (14) OJ L 124, 8.6.1971, p. 1. (15) OJ L 324, 10.12.2009, p. 23. (16) OJ L 152, 16.6.2009, p. 23 (17) OJ L 82, 22.3.1997, p. 1. ANNEX CORRELATION TABLE Regulation (EC) No 450/2008 This Regulation Article 1(1) and (2) Article 1(1) and (2) Article 1(3), first subparagraph Article 1(3) Article 1(3), second subparagraph Article 2 Article 2 Article 3 Article 3 Article 4 Article 4, points 1 to 8 Article 5, points 1 to 8 Article 4, point 9 Article 5, points 9 and 10 Article 4, point 10 Article 5, point 12 Article 4, points 11 and 12 Article 5, points 15 and 16 Article 4, points 13 to 17 Article 5, points 18 to 22 Article 4, point 18(a), first sentence Article 5, point 23(a) Article 4, point 18(a), second sentence Article 130(3) Article 4, point 18(b) and (c) Article 5, point 23(b) and (c) Article 4, points 19 to 26 Article 5, points 24 to 31 Article 4, point 27 to 32 Article 5, points 33 to 38 Article 4, point 33 — Article 5(1), first subparagraph Article 6(1) Article 5(1), second and third subparagraphs Articles 6(3) and 7(b) Article (5)(2) Articles 6(2), 7(a) and 8(1)(a) Article 6 Article 12 Article 7 Article 13 Article 8 Article 14 Article 9 Article 15 Article 10(1) Articles 9 and 16(1) Article 10(2) Articles 10, 11 and 17 Article 11(1), first and second subparagraphs Article 18 Article 11(1), third subparagraph Article 18(2), first subparagraph Article 11(2) Article 18(3) Article 11(3)(a) Article 18(2), second subparagraph and Article 21 Article 11(3)(b) Article 21 Article 11(3)(c) — Article 12(1) Article 19(1) Article 12(2), first subparagraph Article 19(2), first subparagraph Article 12(2), second subparagraph Article 19(2), second subparagraph and Article 20(b) Article 13(1) Article 38(1) Article 13(2) Article 38(2) and (3) Article 13(3) Article 38(4) Article 13(4) Article 38(5), first sentence Article 13(5) — Article 13(6) Article 23(2) Article 14 Article 39 Article 15(1)(a) Article 22, Article 24(a) to (g) and Article 25(a) and (b) Article 15(1)(b) Articles 23(4)(b) and 24(h) Article 15(1)(c) — Article 15(1)(d) Article 22(1), third subparagraph and 24(a) Article 15(1)(e) Article 40(b) Article 15(1)(f) Article 25(b) Article 15(1)(g) Articles 23(4)(b), 24(h), 24(c), 28, 31(b) and 32 Article 15(1)(h) — Article 15(2) — Article 16(1) Article 22(1), first and second subparagraphs Article 16(2) Article 22(3), first and second subparagraphs Article 16(3) Article 22(2) Article 16(4), first subparagraph Article 22(6), first subparagraph, first sentence Article 16(4), second subparagraph Article 22(6), first subparagraph, second sentence and Article 22(7) Article 16(5)(a) Article 22(6), second subparagraph and Article 24(g) Article 16(5)(b) Article 24(f) Article 16(6) Article 23(3) Article 16(7) Article 29 Article 17 Article 26 Article 18(1) to (3) Article 27 Article 18(4) Article 32 Article 19(1) Article 28(1)(a) Article 19(2) and (3) Article 28(2) and (3) Article 19(4) Article 28(4), first subparagraph and second subparagraph, first sentence Article 19(5) Article 31(a) Article 20(1) to (4) Article 33 Article 20(5) Article 34(4) Article 20(6), first subparagraph Article 34(5), first sentence Article 20(6), second subparagraph Article 34(6) Article 20(7) Articles 22, 23, 24, 25 and 32 Article 20(8)(a) Article 34(1) to (3) Article 20(8)(b) Article 34(9) and Article 37(1)(a) Article 20(8)(c) Article 34(11) and 37(2) Article 20(9) Articles 35, 36(b) and 37(1)(c) and (d) Article 21 Article 42 Article 22 Article 43 Article 23 Article 44 Article 24(1) and (2) Article 45(1) and (2) Article 24(3), first subparagraph Article 45(3) Article 24(3), second subparagraph — Article 25(1) Article 46(1) Article 25(2), first subparagraph Article 46(2) Article 25(2), second and third subparagraphs Article 46(3) Article 25(3) Article 46(4) to (8) and Article 50(1) Article 26 Article 47 Article 27 Article 48 Article 28(1) and (2) Article 49 Article 28(3) Article 50(2) Article 29 Article 51 Article 30(1) Article 52 Article 30(2) — Article 31(1) Article 53(1) Article 31(2) Article 53(3) Article 31(3) Article 54 Article 32 Article 55 Article 33(1) to (4) Article 56(1) to (4) Article 33(5) Articles 56(5) and 58(1) Article 34 Article 57(1),(2) and (3) Article 35 Article 59 Article 36 Article 60 Article 37 Article 61 Article 38 Articles 62, 63, 67 and 68 Article 39(1) and (2) Article 64(1) and (2) Article 39(3) Article 64(3), first subparagraph Article 39(4) and (5) Article 64(4) and (5) Article 39(6) Article 64(3), second subparagraph, Article 64(6) and Articles 63 to 68 Article 40 Article 69 Article 41 Article 70 Article 42(1) Article 74(1) Article 42(2) Article 74(2)(a) to (c) and the introductory sentence of point (d) Article 42(3) Article 74(3) Article 43(a) Articles 71, 72 and 76(a) Article 43(b) Article 74(2)(d), points (i), (ii) and (iii) Article 43(c) — Article 43(d) Articles 73 and 75 and Article 76(b) and (c) Article 44 Article 77 Article 45 Article 78 Article 46 Article 79 Article 47 Article 80 Article 48 Article 81 Article 49 Article 82 Article 50 Article 83 Article 51 Article 84 Article 52 Article 85 Article 53(1) to (3) Article 86(1) to (3) Article 53(4) Article 86(6) Article 54(a) and (b) Article 86(5) and Article 88(a) Article 54(c) Article 86(4) and Article 88(b) Article 55(1) Article 87(1) Article 55(2), first subparagraph Article 87(2) Article 55(2), second subparagraph Article 88(c) Article 55(3) and (4) Article 87(3) and (4) Article 56(1) to (5) Article 89(1) to (5) Article 56(6) Article 89(7) Article 56(7) Article 89(9) Article 56(8) Article 89(2), second subparagraph Article 56(9), first indent Article 100(1)(b) Article 56(9), second indent Articles 89(8) and 99(a) Article 56(9), third indent Article 89(2), second subparagraph Article 57(1) and (2) Article 90 Article 57(3) Article 100(1)(a) Article 58, first paragraph Article 91 Article 58, second paragraph — Article 59(1), first subparagraph Article 100(1) Article 59(1), second subparagraph Article 99(b) Article 59(2) Article 92(2) Article 60 Article 93 Article 61 Article 94 Article 62(1) and (2) Article 95(1) and (2) Article 62(3) Article 22, Article 24(a) to (g), Article 25(a) and (b) and Article 99(c) Article 63(1) and (2) — Article 63(3)(a) — Article 63(3)(b) Articles 96(1)(a), 96(2), 100(1)(c) and 100(2) Article 63(3)(c) Article 96(1)(b),96(2), 100(1)(c) and 100(2) Article 64 Article 97 Article 65(1) and (2) Article 98 Article 65(3) Articles 99(d) and 100(1)(b) Article 66 Article 101(1) and (2) Article 67(1), first and second subparagraphs Article 102(1) Article 67(1), third subparagraph Article 106 Article 67(2) and (3) Article 102(2) and (3), first subparagraph Article 68(1) and (2) Article 103(1) and (2) Article 68(3) Article 103(3)(a) Article 68(4) Article 103(4) Article 69 Article 104 Article 70 Article 105(1) to (5) Article 71 Article 105(6) Article 72(1) and (2) Article 108(1) and (2) Article 72(3) Articles 108(3) and 115 Article 73 Article 109 Article 74 Article 110 Article 75 Article 111 Article 76 — Article 77(1), first subparagraph Article 112(1) Article 77(1), second and third subparagraphs Article 112(2) Article 77(2) Article 112(3) Article 77(3) Article 112(4) Article 78(1), first subparagraph Article 113 Article 78(1), second subparagraph Articles 99(d) and 100(1)(b) Article 78(2) to (4) Article 114(1) to (3) Article 78(5) Article 114(4) Article 79(1) Article 116(1) Article 79(2) to (5) Article 116(4) to (7) Article 80 Article 117(1) Article 81(1) and (2) Article 118(1) and (2) Article 81(3) Article 118(4) Article 82(1) Article 119(1) Article 82(2) Article 119(3) Article 83 Article 120(1) Article 84(1) Article 121(1) Article 84(2) Article 121(3) Article 85, first sentence Articles 116(2), 117(2), 118(3), 119(2), 120(2), 121(2) and 123(1) Article 85, second sentence Articles 106(3), 122 and 123(2) Article 86(1) introductory sentence Article 124(1) introductory sentence and point (a) Article 86(1) (a) to (c) Article 124(1) (b) to (d) Article 86(1) (d) and (e) Article 124(1) (e) Article 86(1) (f) to (k) Article 124(1) (f) to (k) Article 86(2) and (3) Article 124(2) and (3) Article 86(4) to (6) Article 124(5) to (7) Article 86(7) Article 126 Article 87(1) Articles 127(1) and 127(2)(a) Article 87(2), first subparagraph Article 127(3), first subparagraph Article 87(2), second subparagraph Article 127(8) Article 87(3), first subparagraph, point (a) Articles 127(2)(b) and 131(a) Article 87(3), first subparagraph, points (b) and (c) Article 131(b) Article 87(3), first subparagraph, point (d) Articles 127(3) and 161(a) Article 87(3), second subparagraph — Article 88(1), first subparagraph, first sentence Article 6(1) Article 88(1), first subparagraph, second sentence Article 127(7) Article 88(1), second subparagraph Article 6(2) Article 88(2) Article 127(4), first subparagraph Article 88(3) Article 127(4), second subparagraph and (6) Article 88(4), first subparagraph Article 133(1), first subparagraph Article 88(4), second and third subparagraphs Articles 6(2) and 7(a) Article 89(1) Article 129(1) Article 89(2) — Article 90 Article 130(1) Article 91 Article 134 Article 92(1), first subparagraph Article 135(1) Article 92(1), second subparagraph Article 135(2) Article 92(1), third subparagraph — Article 92(2) to (5) Article 135(3) to (6) Article 93(1) Article 136 Article 93(2) — Article 94 Article 137 Article 95(1) Article 139(1) Article 95(2) and (3) Article 139(3) and (4) Article 95(4) Article 139(6) Article 96(1) and (2) Article 140 Article 96(3) Article 139(7) Article 97(1) Article 149 Article 97(2) Article 150 Article 98(1) Article 144 Article 98(2) Article 139(5) Article 99 Article 141(1) Article 100 Article 141(2) Article 101(1) Article 153(1) Article 101(2)(a) Articles 153(2) and 156(a) Article 101(2)(b) Articles 156(b) and 157 Article 101(2)(c) Articles 153(3) and 156(c) Article 102 Article 154 Article 103 Articles 155(2) and 156(d) Article 104(1) Article 158(1) Article 104(2) Article 158(3) Article 105(1) Article 159(1) and (2) Article 105(2)(a) and (b) Articles 159(3) and 161(a) Article 105(2)(c) Articles 22(1), third subparagraph, and 25(c) Article 106(1), first subparagraph, first sentence Article 179(1), first subparagraph Article 106(1), first subparagraph, second sentence — Article 106(2) Article 179(3) and (6) Article 106(3) Article 179(5) Article 106(4), first subparagraph, point (a) Article 22, Article 24(a) to (g) and Article 25(a) and (b) Article 106(4), first subparagraph, point (b) Articles 23(4)(a) and 24(h) Article 106(4), first subparagraph, point (c) Article 179(1), second subparagraph, Article 179(2) and Article 180 Article 106(4), first subparagraph, point (d) Article 22(1), third subparagraph and 24(a) Article 106(4), first subparagraph, point (e) Article 25(b) Article 106(4), first subparagraph, point (f) Articles 23(4)(b), 24(h), 28, 31(b) and 32 Article 106(4), first subparagraph, points (g) and (h) Article 181 Article 106(4), second subparagraph — Article 107(1), first sentence Article 6(1) Article 107(1), second sentence Article 182(1) Article 107(2) Article 158(2) Article 107(3) Articles 160, 161(b), 182(2) to (4), 183 and 184 Article 108(1), first subparagraph, first sentence Article 162 Article 108(1), first subparagraph, second and third sentences Article 170(4) Article 108(1), second subparagraph Articles 6(2), 7(a) and 8(1)(a) Article 108(2) Article 163(1) and (2) Article 108(3), first subparagraph Article 6(1) Article 108(3), second subparagraph — Article 108(4) Articles 163(3), 164 and 165(b) Article 109(1) Article 166(1) Article 109(2) Articles 166(2) and 168 (a) Article 109(3) Articles 6(2), 7(a), 8(1)(a) and 165(a) Article 110(1), first subparagraph Article 167(1), first subparagraph Article 110(1), second subparagraph Article 167(1), third subparagraph Article 110(1), third subparagraph Article 167(2) and (3) and Article 168(d) Article 110(2) and (3) Article 167(4) and (5) Article 111(1) Article 170(1) Article 111(2), first sentence Article 170(2) Article 111(2), second sentence Article 170(3)(a) and (b) Article 111(3) Articles 170(3)(c) Article 112(1), first subparagraph Article 172(1) Article 112(1), second subparagraph, first sentence Article 182(2) Article 112(1), second subparagraph, second sentence Article 182(3) Article 112(2) — Article 112(3) Article 172(2) Article 112(4) Articles 176(b) Article 113(1) and (2) Article 173(1) and (2) Article 113(3) Articles 173(3) and 176(c) Article 114(1) Article 174(1) Article 114(2), first subparagraph Article 174(2) Article 114(2), second subparagraph Article 175 Article 115, first paragraph Article 177(1) Article 115, second paragraph Articles 177(2) and 178 Article 116(1) Article 185(1) Article 116(2), first subparagraph, point (a) Article 22, Article 24(a) to (g) and Article 25(a) and (b) Article 116(2), first subparagraph, point (b) Articles 23(4)(a), 23(5), 24(h) and 25(c) Article 116(2), first subparagraph, points (c) and (d) Articles 185(2) and 186(a) Article 116(2), first subparagraph, point (e) Article 22(1), third subparagraph and 24(a) Article 116(2), first subparagraph, point (f) Article 25(b) Article 116(2), first subparagraph, point (g) Articles 23(4)(b), 24(h), 28, 31(b) and 32 Article 116(2), first subparagraph, points (h) and (i) Articles 186(b) and 187 Article 116(2), second subparagraph — Article 117 Article 188 Article 118 Article 189 Article 119(1) and (2) Article 190 Article 119(3) Article 193 Article 120 Article 191 Article 121 Article 192 Article 122 Article 193 Article 123(1) and (2) Article 194 Article 123(3) Article 179(4) Article 124(1) Article 195(1) Article 124(2) Article 195(2) and (3) and Article 196 Article 125 Article 197 Article 126(1) Article 198(1) Article 126(2) Article 198(2), first subparagraph, first sentence Article 127(1) Article 199 Article 127(2) Article 198(3)(d) Article 128 Article 198(2), first subparagraph, second sentence and second subparagraph, Article 198(3)(a) to (c) and Article 200 Article 129 Article 201 Article 130(1) Article 203(1), first subparagraph Article 130(2) to (5) Article 203(2) to (5) Article 131(a) — Article 131(b) Article 204 Article 132 Article 205 Article 133 Article 208(1) Article 134 Articles 202, 203(1), second subparagraph, 203(6), 206, 207 and 209 Article 135 Article 210 Article 136(1) Article 211(1) Article 136(2), first subparagraph, point (a) Article 22, Article 24(a) to (g) and Article 25(a) and (b) Article 136(2), first subparagraph, point (b) Articles 23(4)(a) and 24(h) Article 136(2), first subparagraph, point (c) Article 212(a) Article 136(2), first subparagraph, point (d) Article 22(1), third subparagraph and 24(a) Article 136(2), first subparagraph, point (e) Article 25(b) Article 136(2), first subparagraph, point (f) Articles 23(4)(b), 24(h), 28, 31(b) and 32 Article 136(2), first subparagraph, point (g) — Article 136(2), first subparagraph, point (h) — Article 136(2), second subparagraph — Article 136(3), first subparagraph, point (a) Article 211(3), first subparagraph, point (a) Article 136(3), first subparagraph, point (b) Article 211(3), first subparagraph, points (b) and (c) Article 136(3), first subparagraph, point (c) Article 211(3), first subparagraph, point (d) Article 136(3), second subparagraph Article 212(b) Article 136(4), first subparagraph Article 211(4) Article 136(4), second subparagraph Article 211(5) Article 136(4), third subparagraph Article 211(6) Article 136(4), fourth subparagraph, points (a) and (b) Article 213 Article 136(4), fourth subparagraph, point (c) Article 212(c) Article 136(5) Article 23(2) Article 137(1) Article 214(1) Article 137(2) Article 214(2) and Article 7(c) Article 138 Article 215(1) to (3) Article 139 Article 218 Article 140(1) Article 219 Article 140(2) Articles 221(a) and 222(b) Article 141 Article 220 Article 142(1), first, second and third subparagraphs Article 223(1) Article 142(1), fourth subparagraph Article 224(a) Article 142(2), first subparagraph, point (a) Article 223(2), first subparagraph, point (a) Article 142(2), first subparagraph, points (b) and (c) Article 223(2), first subparagraph, points (c) and (d) Article 142(2), second subparagraph Article 223(2), first subparagraph, point (b) and Article 224(c) Article 142(3), first subparagraph Article 223(3) Article 142(3), second subparagraph Article 224(d) Article 142(4) Article 223(4) Article 143 Articles 211(2), 216, 217, 221(b), 222(b), 224(b), 225, 228, 229, 230, 231(b), 232, 233(4), 235, 236, 243(2), 251(4), 254(2), (3), (6) and (7) and 257(4) Article 144(1) Article 226(1) Article 144(2) Articles 226(2) and 231(a) Article 144(3) Article 226(3) Article 144(4) — Article 145(1) and (2) Article 227 Article 145(3), first subparagraph Article 155(1) Article 145(3), second subparagraph Article 157 Article 146 Article 233(1) to (3) Article 147 Article 234 Article 148(1) Article 237(1) Article 148(2), first subparagraph Article 237(2) Article 148(2), second subparagraph Articles 237(3) and 239 Article 149 Article 242 Article 150(1) Article 238(1) Article 150(2)(a) — Article 150(2)(b) Article 238(2) Article 150(3) — Article 151(1), first subparagraph Article 144 Article 151(1), second subparagraph Article 145(3) Article 151(2) Article 145(5) and (11) Article 151(3) — Article 151(4) Article 147(4) Article 151(5) Article 145(1), (2), (4) and (6) to (10), Article 146, Article 147(3) and (4) and Article 148 and 151 Article 152 Article147(1) and (2) Article 153 Article 240 Article 154(1)(a) Article 237(3), first sentence Article 154(1)(b) Article 241(1) Article 154(2) Article 237(3), second sentence and Article 241(2) Article 155(1) Article 243(1) Article 155(2) and (3) Article 243(3) and (4) Article 156 Article 244 Article 157 Article 245 Article 158 Article 246 Article 159 Article 247 Article 160 Article 248 Article 161 Article 249 Article 162 Article 250 Article 163 Article 251(1) to (3) Article 164, first paragraph Article 253 Article 164, second paragraph — Article 165 Article 252 Article 166(1) Article 254(1) Article 166(2) and (3) Article 254(4) and (5) Article 167 Article 255 Article 168 Article 256 Article 169 Article 257(1) to (3) Article 170 Article 258 Article 171(1) and (2) Article 259(1) and (2) Article 171(3) Article 86(5) Article 171(4) Article 259(3) Article 172 Article 260 Article 173 Article 261 Article 174 Article 262 Article 175(1), first subparagraph Article 263(1) Article 175(1), second subparagraph Article 263(2)(a) Article 175(2) and (3) Article 263(3) and (4) Article 176(1)(a) and (b) Article 263(2)(b) and Article 265(b) Article 176(1)(c) and (d) Article 265(b) Article 176(1)(e) Article 161(a) Article 176(2) — Article 177(1) and (2) Article 267(1) and (3) Article 177(3) Article 267(2) Article 177(4) Article 267(2) Article 177(5) Article 268 Article 178(1) Article 269(1) Article 178(2)(a) Article 269(2)(a) and (b) Article 178(2)(b) Article 269(2)(d) and (e) Article 178(3) Articles 269(3) Article 179 Article 270 Article 180(1) Article 271(1), first subparagraph Article 180(2), first sentence Article 6(1) Article 180(2), second sentence Article 271(3) Article 180(3), first subparagraph Article 6(2) Article 180(3), second subparagraph Article 271(4) Article 180(4) Article 271(2) Article 181, first and second paragraphs Article 272(1) Article 181, second paragraph and third paragraph — Article 182(1) Article 277 Article 182(2) — Article 183(1) Articles 16(1) and 17 Article 183(2)(a) and (b) — Article 183(2)(c) Articles 280 and 283 Article 184 Article 285 Article 185 — Article 186 Article 286(2) and (3) Article 187 Article 287 Article 188(1) Article 288(1) Article 188(2) Article 288(2) Article 188(3) Article 288(1)

Union Customs Code Union Customs Code SUMMARY OF: Regulation (EU) No 952/2013 — laying down the Union Customs Code WHAT IS THE AIM OF THE REGULATION? The regulation establishes the Union Customs Code (UCC), setting out the general rules and procedures applicable to goods brought into or taken out of the customs territory of the European Union, adapted to modern trade models and communication tools. KEY POINTS The UCC and the related delegated and implementing acts (adopted by the European Commission under the regulation) aim to: offer greater legal certainty and uniformity to businesses; increase clarity for customs officials throughout the EU; complete the shift by customs to a paperless and fully electronic environment; simplify customs rules and procedures and facilitate more-efficient customs transactions in line with modern-day needs; reinforce swifter customs procedures for compliant and trustworthy businesses (authorised economic operators); safeguard the financial and economic interests of the EU and of the EU Member States, as well as the safety and security of EU citizens. Amendments The regulation has been amended on a number of occasions. The amendments include: Regulation (EU) 2016/2339, providing exemptions from customs declarations for goods that have temporarily left the EU customs territory by sea or air; Regulation (EU) 2019/474, which amended the scope of the customs territory at the request of a Member State and introduced some technical amendments; Regulation (EU) 2019/632, allowing customs authorities and businesses to continue using existing IT systems or paper-based arrangements for a limited number of customs formalities until 2025 at the latest, when new or upgraded IT systems will be in place. The delegated and implementing acts have also been amended on several occasions (see consolidated versions in the section ‘Related documents’ below). Electronic customs systems Implementing Regulation (EU) 2021/414 sets out the technical arrangements for developing, maintaining and employing electronic customs systems. As of 29 March 2021, it replaced and repealed Implementing Regulation (EU) 2019/1026. It applies to: the Customs Decisions System (CDS); the Uniform User Management and Digital Signature (UUM & DS) system; the European Binding Tariff Information (EBTI) system; the Economic Operators Registration and Identification (EORI) system; the Authorised Economic Operator (AEO) system; the Import Control System 2 (ICS2); the Automated Export System (AES); the New Computerised Transit System (NCTS); the Information Sheets for Special Procedures (INF SP) system; the Centralised Clearance for Import (CCI) system. It also applies to the following electronic systems: the European Union Customs Trader Portal; the Customs Risk Management System (CRMS). FROM WHEN DOES THE REGULATION APPLY? It has applied in its entirety since 1 May 2016. Regulation (EU) No 952/2013 revised and replaced Regulation (EC) No 450/2008 and its subsequent amendments. BACKGROUND For further information: Union Customs Code (UCC) (European Commission) EU Customs facts and figures (European Commission) UCC — Legislation (European Commission). MAIN DOCUMENT Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (recast) (OJ L 269, 10.10.2013, pp. 1-101) Successive amendments to Regulation (EU) No 952/2013 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Implementing Regulation (EU) 2021/414 of 8 March 2021 on technical arrangements for developing, maintaining and employing electronic systems for the exchange and storage of information under Regulation (EU) No 952/2013 of the European Parliament and of the Council (OJ L 81, 9.3.2021, pp. 37-64) Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee — Taking the Customs Union to the next level: a plan for action (COM(2020) 581 final, 28.9.2020) Commission staff working document — 2nd Biennial Report on Progress in Developing the EU Customs Union and its Governance (SWD(2020) 213 final, 28.9.2020) Commission Implementing Decision (EU) 2019/2151 of 13 December 2019 establishing the work programme relating to the development and deployment of the electronic systems provided for in the Union Customs Code (OJ L 325, 16.12.2019, pp. 168-182) Communication from the Commission to the Council and the European Parliament — First Biennial Report on Progress in Developing the EU Customs Union and its Governance (COM(2018) 524 final, 5.7.2018) Report from the Commission to the European Parliament and the Council on the implementation of the Union Customs Code and on the exercise of the power to adopt delegated acts pursuant to Article 284 thereunder (COM(2018) 39 final, 22.1.2018) Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee — Developing the EU Customs Union and its governance (COM(2016) 813 final, 21.12.2016) Commission Delegated Regulation (EU) 2015/2446 of 28 July 2015 supplementing Regulation (EU) No 952/2013 of the European Parliament and of the Council as regards detailed rules concerning certain provisions of the Union Customs Code (OJ L 343, 29.12.2015, pp. 1-557) See consolidated version. Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, pp. 558-893) See consolidated version. last update 17.05.2021

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14.6.2018 EN Official Journal of the European Union L 150/1 REGULATION (EU) 2018/848 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Organic production is an overall system of farm management and food production that combines best environmental and climate action practices, a high level of biodiversity, the preservation of natural resources and the application of high animal welfare standards and high production standards in line with the demand of a growing number of consumers for products produced using natural substances and processes. Organic production thus plays a dual societal role, where, on the one hand, it provides for a specific market responding to consumer demand for organic products and, on the other hand, it delivers publicly available goods that contribute to the protection of the environment and animal welfare, as well as to rural development. (2) The observance of high standards for health, the environment and animal welfare in the production of organic products is intrinsic to the high quality of those products. As underlined in the communication of the Commission of 28 May 2009 on agricultural product quality policy, organic production forms part of the Union’s agricultural product quality schemes, together with geographical indications and traditional specialities guaranteed in accordance with Regulation (EU) No 1151/2012 of the European Parliament and of the Council (4) and products of the outermost regions of the Union in accordance with Regulation (EU) No 228/2013 of the European Parliament and of the Council (5). In this sense, organic production pursues the same objectives within the common agricultural policy (‘CAP’), which are inherent to all the agricultural product quality schemes of the Union. (3) In particular, the objectives of the organic production policy are embedded in the objectives of the CAP by ensuring that farmers receive a fair return for complying with the organic production rules. In addition, the growing consumer demand for organic products creates conditions for further development and expansion of the market in those products and thus for an increase in the return of farmers engaged in organic production. (4) Furthermore, organic production is a system that contributes to the integration of environmental protection requirements into the CAP and that promotes sustainable agricultural production. This is why measures that support organic production financially have been introduced under the CAP, notably under Regulation (EU) No 1307/2013 of the European Parliament and of the Council (6), and strengthened, in particular, in the reform of the legal framework for rural development policy established by Regulation (EU) No 1305/2013 of the European Parliament and of the Council (7). (5) Organic production also contributes to the achievement of the objectives of the Union’s environmental policy, in particular those set out in the communications of the Commission of 22 September 2006 entitled ‘Thematic Strategy for Soil Protection’, of 3 May 2011 entitled ‘Our life insurance, our natural capital: an EU biodiversity strategy to 2020’ and of 6 May 2013 entitled ‘Green Infrastructure (GI) — Enhancing Europe’s Natural Capital’, and in environmental legislation such as Directives 2000/60/EC (8), 2001/81/EC (9), 2009/128/EC (10) and 2009/147/EC (11) of the European Parliament and of the Council and Council Directives 91/676/EEC (12) and 92/43/EEC (13). (6) In view of the objectives of the Union’s organic production policy, the legal framework established for implementing that policy should aim at ensuring fair competition and the proper functioning of the internal market in organic products, at maintaining and justifying consumer confidence in products labelled as organic, and at providing conditions under which the policy can progress in line with production and market developments. (7) The policy priorities of the Europe 2020 strategy, set out in the communication of the Commission of 3 March 2010 entitled ‘Europe 2020: A strategy for smart, sustainable and inclusive growth’, include achieving a competitive economy based on knowledge and innovation, fostering a high-employment economy delivering social and territorial cohesion, and supporting the shift towards a resource-efficient and low-carbon economy. The organic production policy should therefore provide operators with the right tools to better identify and promote their products while protecting them against unfair practices. (8) The organic farming sector in the Union has developed rapidly in the past years, in terms not only of the area used for organic farming but also of the number of holdings and the overall number of organic operators registered in the Union. (9) Given the dynamic evolution of the organic sector, Council Regulation (EC) No 834/2007 (14) identified the need for a future review of the Union rules on organic production, taking into account the experience gained from the application of those rules. The results of that review carried out by the Commission show that the Union legal framework governing organic production should be improved to provide for rules that correspond to the high expectations of consumers and that guarantee sufficient clarity for those to whom they are addressed. Regulation (EC) No 834/2007 should be therefore repealed and replaced by a new Regulation. (10) Experience gained so far with the application of Regulation (EC) No 834/2007 shows the need to make clear to which products this Regulation applies. Primarily, it should cover products originating from agriculture, including aquaculture and beekeeping, as listed in Annex I to the Treaty on the Functioning of the European Union (TFEU). Moreover, it should cover processed agricultural products for use as food or feed because the placing of such products on the market as organic products provides a major outlet for agricultural products and ensures that the organic nature of the agricultural products from which they are processed is visible to the consumer. Likewise, this Regulation should cover certain other products which are linked to agricultural products in a similarly close way as processed agricultural products for use as food and feed because those other products either constitute a major outlet for agricultural products or form an integral part of the production process. Finally, sea salt and other salts used for food and feed should be included in the scope of this Regulation because they may be produced by applying natural production techniques, and because their production contributes to the development of rural areas, and thus falls within the objectives of this Regulation. For reasons of clarity, such other products not listed in Annex I to the TFEU should be listed in an Annex to this Regulation. (11) In order to supplement or amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (15). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (12) In order to take into account new production methods, new materials or international commitments, the power to adopt certain acts should be delegated to the Commission in respect of enlarging the list of other products closely linked to agriculture falling within the scope of this Regulation. (13) Products covered by this Regulation but originating from hunting or fishing of wild animals should not be considered organic since their production process cannot be fully controlled. (14) Because of the local nature of mass catering operations, measures taken by Member States and private schemes in this area are considered adequate to ensure the functioning of the single market. Therefore, food prepared by mass caterers on their premises should not be subject to this Regulation and should therefore not be labelled or advertised with the organic production logo of the European Union. (15) Research projects have demonstrated that consumer confidence is crucial in the market for organic food. In the long run, rules that are not trustworthy can jeopardise public confidence and lead to market failure. Therefore, the sustainable development of organic production in the Union should be based on sound production rules which are harmonised at Union level and which meet operators’ and consumers’ expectations regarding the quality of organic products and compliance with the principles and rules laid down in this Regulation. (16) This Regulation should apply without prejudice to related legislation, in particular in the fields of safety of the food chain, animal health and welfare, plant health, plant reproductive material, labelling and the environment. (17) This Regulation should provide the basis for the sustainable development of organic production and its positive effects on the environment, while ensuring the effective functioning of the internal market in organic products and fair competition, thereby helping farmers to achieve a fair income, ensuring consumer confidence, protecting consumer interest and encouraging short distribution channels and local production. Those objectives should be achieved through compliance with general and specific principles and general and detailed production rules applicable to organic production. (18) Having regard to the particularities of the organic production systems, the choice of plant varieties should focus on agronomic performance, genetic diversity, disease resistance, longevity, and adaptation to diverse local soil and climate conditions, and should respect the natural crossing barriers. (19) The risk of non-compliance with organic production rules is considered higher in agricultural holdings which include units that are not managed under those rules. Therefore, after an appropriate conversion period, all agricultural holdings in the Union which aim to become organic should be entirely managed in compliance with the requirements applicable to organic production. However, holdings including both units managed under organic production rules and units managed under non-organic production rules should be allowed under certain conditions, including in particular the condition of clear and effective separation between organic, in-conversion and non-organic production units and between the products produced by those units. (20) Since the use of external inputs should be restricted in organic production, certain objectives should be identified for which products and substances are often used in the production of agricultural products or processed agricultural products. When normally used for those objectives, the use of products or substances should only be allowed when they have been authorised in accordance with this Regulation. However, such authorisation should only be valid as long as the use of such external inputs in non-organic production is not prohibited by Union law or by national law that is based on Union law. The use of products or substances which plant protection products contain or consist of, other than active substances, should be allowed in organic production as long as their use is authorised in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (16) and as long as neither the placing of those plant protection products on the market nor use of those plant protection products is prohibited by Member States in accordance with that Regulation. (21) When the entire holding or parts of the holding are intended to produce organic products, they should be subject to a conversion period during which they are managed under organic production rules, but cannot produce organic products. Products should only be allowed to be placed on the market as organic products once the conversion period has elapsed. That period should not start before the farmer or operator producing algae or aquaculture animals has notified that conversion to organic production to the competent authorities of the Member State where the holding is situated, and is therefore subject to the control system that is to be set up by Member States in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (17) and this Regulation. Competent authorities should only be able retroactively to recognise periods before the date of notification as conversion periods where the holding or the relevant parts thereof have been subject to agri-environmental measures supported by Union funds or are natural or agricultural areas which for a period of at least three years have not been treated with products or substances not authorised for use in organic production. (22) In order to ensure quality, traceability, compliance with this Regulation as regards organic production and adaptation to technical developments, the power to adopt certain acts should be delegated to the Commission in respect of further rules on the splitting of holdings into organic, in-conversion and non-organic production units. (23) The use of ionising radiation, animal cloning and artificially induced polyploid animals or genetically modified organisms (‘GMOs’), as well as products produced from or by GMOs, is incompatible with the concept of organic production and consumers’ perception of organic products. Such use should therefore be prohibited in organic production. (24) In order to support and facilitate compliance with this Regulation, operators should take preventive measures at every stage of production, preparation and distribution, where appropriate, to ensure the preservation of biodiversity and soil quality, to prevent and control pests and diseases and to avoid negative effects on the environment, animal health and plant health. They should also take, where appropriate, proportionate precautionary measures which are under their control to avoid contamination with products or substances that are not authorised for use in organic production in accordance with this Regulation and to avoid commingling organic, in-conversion and non-organic products. (25) Products produced during the conversion period should not be placed on the market as organic products. To avoid the risk of confusing and misleading consumers, those products also should not be marketed as in-conversion products, except in the cases of plant reproductive material, food products of plant origin and feed products of plant origin that have only one agricultural crop ingredient, in all cases subject to the condition that a conversion period of at least 12 months before the harvest has been complied with. (26) In order to ensure quality, traceability, compliance with this Regulation and adaptation to technical developments, the power to adopt certain acts should be delegated to the Commission in respect of conversion rules for further animal species. (27) Detailed production rules should be established with regard to plant, livestock and aquaculture production, including rules for the collection of wild plants and algae, and with regard to the production of processed food and feed, as well as of wine and yeast used as food or feed, to ensure harmonisation of and compliance with the objectives and principles of organic production. (28) As organic plant production is based on nourishing the plants primarily through the soil ecosystem, plants should be produced on and in living soil in connection with the subsoil and bedrock. Consequently, hydroponic production should not be allowed, nor growing plants in containers, bags or beds where the roots are not in contact with the living soil. (29) However, certain cultivation practices which are not soil-related, such as the production of sprouted seeds or chicory heads and the production of ornamentals and herbs in pots that are sold in pots to the consumers, for which the principle of soil-related crop cultivation is not adapted or for which no risk exists that the consumer is misled regarding the production method, should be allowed. In order to facilitate organic production at an earlier growing stage of plants, growing seedlings or transplants in containers for further transplanting should also be permitted. (30) The principle of land-related crop cultivation and the nourishing of plants primarily through the soil ecosystem was established by Regulation (EC) No 834/2007. Some operators have, however, developed an economic activity by growing plants in ‘demarcated beds’ and have been certified as organic under Regulation (EC) No 834/2007 by their national authorities. An agreement has been reached within the ordinary legislative procedure on 28 June 2017 that the organic production should be based on nourishing the plants primarily through the soil ecosystem and be soil-related, and that growing plants in demarcated beds should not be allowed anymore from that date. In order to give the operators who have developed such economic activity until that date the possibility to adapt, they should be allowed to maintain their production surfaces, if they were certified as organic under Regulation (EC) No 834/2007 before that date by their national authorities, for further 10 years after the date of application of this Regulation. On the basis of the information provided by Member States to the Commission, such activity had only been authorised in the Union before 28 June 2017 in Finland, Sweden and Denmark. The use of demarcated beds in organic agriculture should be subject to a report of the Commission which is to be published five years after the date of application of this Regulation. (31) Organic plant production should involve the use of production techniques that prevent or minimise any contribution to the contamination of the environment. (32) While non-organic agriculture has more external means to adapt to the environment to achieve optimal crop growth, organic plant production systems need plant reproductive material which is able to adapt to disease resistance, diverse local soil and climate conditions and to the specific cultivation practices of organic agriculture contributing to the development of the organic sector. Therefore, it is important to develop organic plant reproductive material suitable for organic agriculture. (33) Concerning soil management and fertilisation, cultivation practices allowed in organic plant production should be specified and conditions should be laid down for the use of fertilisers and conditioners. (34) The use of plant protection products should be significantly restricted. Preference should be given to measures to prevent damage by pests and weeds through techniques which do not involve the use of plant protection products, such as crop rotation. Presence of pests and weeds should be monitored to decide whether any intervention is economically and ecologically justified. However, the use of certain plant protection products should be allowed if such techniques do not provide adequate protection and only if those plant protection products have been authorised in accordance with Regulation (EC) No 1107/2009, after having been assessed and found to be compatible with the objectives and principles of organic production, including where those products have been authorised subject to restrictive conditions of use, and consequently have been authorised in accordance with this Regulation. (35) In order to ensure quality, traceability, compliance with this Regulation and adaptation to technical developments, the power to adopt certain acts should be delegated to the Commission in respect of certain derogations, the use of in-conversion or non-organic plant reproductive material, agreements between operators of agricultural holdings, further pest and weed management measures, and further detailed rules and cultivation practices for specific plants and plant production. (36) Research in the Union on plant reproductive material that does not fulfil the variety definition as regards uniformity shows that there could be benefits of using such diverse material, in particular with regard to organic production, for example to reduce the spread of diseases, to improve resilience and to increase biodiversity. (37) Therefore, plant reproductive material that does not belong to a variety, but rather belongs to a plant grouping within a single botanical taxon with a high level of genetic and phenotypic diversity between individual reproductive units, should be available for use in organic production. For that reason, operators should be allowed to market plant reproductive material of organic heterogeneous material without having to comply with the requirements for registration and without having to comply with the certification categories of pre-basic, basic and certified material or with the requirements for other categories set out in Council Directives 66/401/EEC (18), 66/402/EEC (19), 68/193/EEC (20), 98/56/EC (21), 2002/53/EC (22), 2002/54/EC (23), 2002/55/EC (24), 2002/56/EC (25), 2002/57/EC (26), 2008/72/EC (27) and 2008/90/EC (28), or in acts adopted pursuant to those Directives. That marketing should take place following a notification to the responsible bodies referred to in those Directives and, after the Commission has adopted harmonised requirements for such material, provided that it complies with those requirements. (38) In order to ensure quality, traceability, compliance with this Regulation and adaptation to technical developments, the power to adopt certain acts should be delegated to the Commission in respect of setting out certain rules for the production and marketing of plant reproductive material of organic heterogeneous material of particular genera or species. (39) In order to meet the needs of organic producers, to foster research and to develop organic varieties suitable for organic production, taking into account the specific needs and objectives of organic agriculture such as enhanced genetic diversity, disease resistance or tolerance and adaptation to diverse local soil and climate conditions, a temporary experiment should be organised in accordance with Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC. That temporary experiment should be for a term of seven years, should involve sufficient quantities of plant reproductive material and should be subject to yearly reporting. It should help to establish the criteria for the description of the characteristics of that material and to determine the production and marketing conditions for that material. (40) As livestock production naturally involves the management of agricultural land, where manure is used to nourish crop production, landless livestock production should be prohibited, except in the case of beekeeping. In the choice of breeds, the choice of characteristics that are important for organic agriculture, such as a high degree of genetic diversity, the capacity to adapt to local conditions and disease resistance, should be encouraged. (41) Organic animals are not always available in sufficient quantity and quality to meet the needs of farmers who wish to constitute a herd or a flock for the first time or to increase or renew their livestock. Under certain conditions, it should therefore be possible to bring non-organically raised animals to an organic production unit. (42) Livestock should be fed on feed materials produced in accordance with the rules of organic production, and preferably coming from the farmer’s own holding, taking into account the physiological needs of the livestock. However, farmers should be given the possibility to use also in-conversion feed coming from their own holdings, under certain conditions. In addition, in order to provide for the basic nutritional requirements of livestock, farmers should be allowed to use certain feed material of microbial or of mineral origin or certain feed additives and processing aids under well-defined conditions. (43) Animal health management should mainly be based on the prevention of disease. In addition, specific cleaning and disinfection measures should be applied. The preventive use of chemically synthesised allopathic medicinal products, including antibiotics, should not be permitted in organic production. In the event of sickness or injury of an animal requiring immediate treatment, the use of such products should be limited to the minimum necessary to re-establish the well-being of the animal. In such cases, in order to guarantee the integrity of organic production for consumers, the official withdrawal period after use of such medicinal products as specified in the relevant Union legislation should be double the normal withdrawal period and have a minimum duration of 48 hours. (44) Organic livestock housing conditions and husbandry practices should satisfy the behavioural needs of the animals and should ensure a high level of animal welfare, certain aspects of which should go beyond the Union animal welfare standards applicable to livestock production in general. In most cases, livestock should have permanent access to open-air areas for exercise. Any suffering, pain or distress should be avoided, or should be kept to a minimum at all stages of the animals’ lives. Tethering and mutilation, such as tail-docking for sheep, beak trimming in the first three days of life and disbudding, should only be possible if allowed by competent authorities, and only under certain conditions. (45) Since organic production is the most developed for bovine animals, ovine animals, caprine animals, equine animals, cervine animals and porcine animals, as well as for poultry, rabbits and bees, additional detailed production rules should apply to those species. For those species it is necessary for the Commission to lay down certain requirements that are important for the production of those animals, such as requirements for stocking density, minimum surfaces and characteristics, as well as technical requirements for housing. For other species, such requirements should be laid down once additional detailed production rules apply to those species. (46) In order to ensure quality, traceability, compliance with this Regulation and adaptation to technical developments, the power to adopt certain acts should be delegated to the Commission in respect of the reduction of the derogations concerning the origin of animals, limits on organic nitrogen linked to the total stocking density, the feeding of bee colonies, acceptable treatments for the disinfection of apiaries, methods and treatments to fight against Varroa destructor, and detailed livestock production rules for further species. (47) This Regulation reflects the objectives of the new Common Fisheries Policy as regards aquaculture, which plays a key role in ensuring sustainable, long-term food security as well as growth and employment, while reducing pressure on wild fish stocks, in the context of growing global aquatic food demand. The communication of the Commission of 29 April 2013 on Strategic Guidelines for the sustainable development of EU aquaculture highlights the main challenges faced by aquaculture in the Union and its potential for growth. That communication identifies organic aquaculture as a particularly promising sector, and highlights the competitive advantages that derive from organic certification. (48) Organic aquaculture is a relatively new field of organic production as compared to organic agriculture, where long experience exists at the farm level. Given consumers’ growing interest in organic aquaculture products, further growth in the rate of conversions of aquaculture units to organic production is likely. This will lead to increased experience, technical knowledge and development, with improvements in organic aquaculture that should be reflected in the production rules. (49) Organic aquaculture should be based on the rearing of young stock originating from organic production units. Organic aquaculture animals for breeding or on-growing purposes are not always available in sufficient quantity and quality to meet the needs of operators that produce aquaculture animals. Under certain conditions, it should be possible to bring wild caught or non-organic aquaculture animals to an organic production unit. (50) In order to ensure quality, traceability, compliance with this Regulation and adaptation to technical developments, the power to adopt certain acts should be delegated to the Commission in respect of feed for aquaculture animals and the veterinary treatment of those animals, and in respect of detailed conditions for broodstock management, breeding and juvenile production. (51) Operators producing organic food or feed should follow appropriate procedures based on the systematic identification of critical processing steps, in order to ensure that processed products comply with the organic production rules. Processed organic products should be produced using processing methods which guarantee that the organic characteristics and qualities of the products are maintained through all stages of organic production. (52) Provisions concerning the composition of processed organic food and feed should be laid down. In particular, such food should be produced mainly from organic agricultural ingredients or from other ingredients falling within the scope of this Regulation that are organic, with the limited possibility of using certain non-organic agricultural ingredients specified in this Regulation. In addition, only certain products and substances authorised in accordance with this Regulation should be allowed for use in the production of processed organic food and feed. (53) In order to ensure quality, traceability, compliance with this Regulation and adaptation to technical developments, the power to adopt certain acts should be delegated to the Commission in respect of precautionary and preventive measures to be taken by operators producing processed food or feed, in respect of the type and composition of products and substances that are allowed for use in processed food, as well as conditions under which they may be used, and in respect of the calculation of the percentage of agricultural ingredients, including the specification of the additives allowed for use in organic production that are considered as agricultural ingredients for the purpose of calculating the percentage that needs to be achieved in order to describe the product as organic in the sales description. (54) Organic wine should be subject to the relevant rules on processed organic food. However, since wine is a specific and important category of organic products, additional detailed production rules should be laid down specifically for organic wine. Organic wine should be produced entirely from organic raw material, and only certain products and substances authorised in accordance with this Regulation should be allowed to be added. The use of certain oenological practices, processes and treatments in the production of organic wine should be prohibited. Other practices, processes and treatments should be permitted under well-defined conditions. (55) In order to ensure quality, traceability, compliance with this Regulation and adaptation to technical developments, the power to adopt certain acts should be delegated to the Commission in respect of specifying additional prohibited oenological practices, processes and treatments and in respect of amending the list of permitted oenological practices, processes and treatments. (56) Initially, yeast was not considered an agricultural ingredient under Regulation (EC) No 834/2007 and therefore it did not count for the agricultural composition of organic products. However, Commission Regulation (EC) No 889/2008 (29) introduced the obligation to consider yeast and yeast products as agricultural ingredients for the purposes of organic production from 31 December 2013. Accordingly, from 1 January 2021, only organically produced substrates should be used in the production of organic yeast for use as food and feed. In addition, only certain products and substances should be allowed for use in its production, confection and formulation. (57) In order to ensure quality, traceability, compliance with this Regulation and adaptation to technical developments, the power to adopt certain acts should be delegated to the Commission in respect of additional detailed yeast production rules. (58) While this Regulation should harmonise the organic production rules in the Union for all products falling within its scope, and should lay down detailed production rules for different categories of products, it will only be possible at a later stage to adopt certain production rules, such as additional detailed production rules for further animal species or for products that do not fall within the categories for which detailed production rules have been laid down in this Regulation. In the absence of such production rules at Union level, Member States should still have the possibility to lay down national rules for their own national production, provided that those rules are not contrary to this Regulation. However, Member States should not apply those national rules to products produced or marketed in other Member States where those products comply with this Regulation. In the absence of such national detailed production rules, operators should at least comply with the general production rules and with the principles for organic production, insofar as those rules and principles could apply to the products concerned, when placing such products on the market with terms referring to organic production. (59) In order to take account of any future need to have specific production rules for products whose production does not fall within any of the categories of specific production rules laid down in this Regulation, as well as in order to ensure quality, traceability, compliance with this Regulation and, subsequently, adaptation to technical developments, the power to adopt certain acts should be delegated to the Commission in respect of laying down detailed production rules, as well as rules on the obligation to convert, for such products. (60) Exceptions from organic production rules should be provided for only in the event of catastrophic circumstances. In order to allow organic production to continue or recommence in such cases, the power to adopt certain acts should be delegated to the Commission in respect of laying down the criteria to determine whether a situation qualifies as catastrophic circumstances as well as specific rules, including possible derogation from this Regulation, on how Member States are to deal with such catastrophic circumstances and on the necessary monitoring and reporting requirements in such cases. (61) Under certain conditions organic products, in-conversion products and non-organic products can be collected and transported simultaneously. In order to duly separate organic, in-conversion and non-organic products during their handling and to avoid any commingling, specific provisions should be laid down. (62) In order to ensure the integrity of organic production and adaptation to technical developments, the power to adopt certain acts should be delegated to the Commission in respect of rules on packaging and transport of organic products. (63) The use in organic production of certain products or substances as active substances to be used in plant protection products falling within the scope of Regulation (EC) No 1107/2009, fertilisers, soil conditioners, nutrients, non-organic components of animal nutrition of various origin, feed additives, processing aids and products for cleaning and disinfection should be limited to the minimum and made subject to the specific conditions laid down in this Regulation. The same approach should be followed regarding the use of products and substances as food additives and processing aids and regarding the use of non-organic agricultural ingredients in the production of processed organic food. Therefore, any possible use of such products and substances in organic production in general, and in the production of processed organic food in particular, should be defined, subject to the principles laid down in this Regulation and to certain criteria. (64) In order to ensure quality, traceability, and compliance with this Regulation as regards organic production in general and the production of processed organic food in particular, as well as to ensure adaptation to technical developments, the power to adopt certain acts should be delegated to the Commission in respect of additional criteria for the authorisation of products and substances for use in organic production in general, and in the production of processed organic food in particular, as well as criteria for the withdrawal of such authorisations. (65) In order to ensure access to agricultural ingredients, where such ingredients are not available in organic form in sufficient quantity for the production of processed organic food, Member States should also have the possibility to allow the use of non-organic agricultural ingredients under certain conditions and for a limited period. (66) In order to foster organic production and address the need for reliable data, information and data on the availability on the market for organic and in-conversion plant reproductive material, for organic animals and for organic aquaculture juveniles needs to be collected and disseminated to farmers and operators. For that purpose, Member States should ensure that regularly updated databases and systems with such information are established on their territories, and the Commission should make such information public. (67) In order to ensure compliance with the requirements for organic production and to ensure consumer trust in this production method, it is necessary that operators inform competent authorities, or, where appropriate, control authorities or control bodies, of cases of suspicion of non-compliance with this Regulation, which is substantiated or cannot be eliminated, concerning products they produce, prepare, import or receive from other operators. Such suspicion may, inter alia, arise due to the presence of a product or substance that is not authorised for use in the production of a product that is intended to be used or marketed as an organic or in-conversion product. Operators should inform competent authorities where they are in position to substantiate a suspicion of non-compliance or where they cannot eliminate such a suspicion. In such cases, the products concerned should not be placed on the market as organic or in-conversion products for as long as the suspicion cannot be eliminated. Operators should cooperate with the competent authorities, and, where appropriate, with the control authorities or control bodies, in identifying and verifying the reasons for such non-compliance. (68) In order to avoid the contamination of organic production with products or substances that have not been authorised by the Commission for use in organic production for certain purposes, operators should take proportionate and appropriate measures which are under their control to identify and avoid risks of such contamination. Such measures should be regularly reviewed and adjusted if necessary. (69) In order to ensure a harmonised approach across the Union as regards the measures to be taken in the case of suspicion of non-compliance, especially where such suspicion arises due to the presence of non-authorised products and substances in organic or in-conversion products, and to avoid uncertainties for operators, competent authorities, or, where appropriate, control authorities or control bodies, should carry out an official investigation in accordance with Regulation (EU) 2017/625 in order to verify compliance with the requirements for organic production. In the specific case of suspicion of non-compliance due to the presence of non-authorised products or substances, the investigation should determine the source and the cause of the presence of such products or substances, in order to ensure that operators comply with the requirements for organic production and, in particular, have not used products or substances that are not authorised for use in organic production, and to ensure that those operators have taken proportionate and appropriate precautionary measures to avoid the contamination of organic production with such products and substances. Such investigations should be proportionate to the suspected non-compliance, and therefore should be completed as soon as possible within a reasonable period, taking into account the durability of the product and the complexity of the case. They could include any method and technique for official controls which is considered appropriate to efficiently eliminate or confirm, without any unnecessary delay, any suspicion of non-compliance with this Regulation, including the use of any relevant information that would permit the elimination or confirmation of any suspicion of non-compliance without an on-the spot inspection. (70) The occurrence of the presence of products or substances that are not authorised for use in organic production in products that are marketed as organic or in-conversion products, as well as the measures taken in that respect, should be subject to further observation by Member States and the Commission. The Commission should therefore present a report to the European Parliament and the Council four years after the date of application of this Regulation, based on the information collected by Member States about the cases where non-authorised products and substances in organic production have been investigated. Such report could be accompanied, if appropriate, by a legislative proposal for further harmonisation. (71) In the absence of such further harmonisation, Member States that have developed approaches to avoid products that contain a certain level of products or substances not authorised for use in organic production for certain purposes being marketed as organic or in-conversion products should have the possibility to keep applying those approaches. However, in order to ensure the free movement of organic and in-conversion products in the internal market of the Union, such approaches should not prohibit, restrict or impede the placing of products produced in other Member States in compliance with this Regulation on the market. Such approaches should therefore only be applied to products produced on the territory of the Member State that has chosen to continue to apply that approach. Member States that decide to use this possibility should inform the Commission without delay. (72) In addition to the obligations concerning measures to be taken by operators producing, preparing, importing or using organic and in-conversion products and by competent authorities, or, where appropriate, by control authorities or control bodies, laid down in this Regulation in order to avoid the contamination of organic or in-conversion products with products or substances not authorised for use in organic production, Member States should also have the possibility of taking other appropriate measures on their territory to avoid the unintended presence of non-authorised products and substances in organic agriculture. Member States that decide to use this possibility should inform the Commission and other Member States without delay. (73) The labelling of agricultural products and foodstuffs should be subject to the general rules laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council (30), and in particular to the provisions aimed at preventing labelling that might confuse or mislead consumers. In addition, specific provisions relating to the labelling of organic and in-conversion products should be laid down in this Regulation. They should protect both the interests of operators in having their products correctly identified on the market and in enjoying conditions of fair competition, and the interests of consumers in being able to make informed choices. (74) Accordingly, the terms used to indicate organic products should be protected throughout the Union against their use in the labelling of non-organic products, independently of the language used. That protection should also apply to the usual derivatives or diminutives of those terms, whether they are used alone or combined. (75) Processed food should be labelled as organic only where all or almost all of the ingredients of agricultural origin are organic. To encourage the use of organic ingredients, it should also be possible to refer to organic production only in the list of ingredients of processed food where certain conditions are satisfied, in particular that the food in question complies with certain organic production rules. Special labelling provisions should also be laid down to allow operators to identify the organic ingredients that are used in products which consist mainly of an ingredient that stems from hunting or fishing. (76) Processed feed should be labelled as organic only where all or almost all the ingredients of agricultural origin are organic. (77) In order to create clarity for consumers throughout the Union market, the use of the organic production logo of the European Union should be obligatory for all organic prepacked food produced within the Union. In addition, it should be possible to use that logo on a voluntary basis in the case of non-prepacked organic products that are produced within the Union and in the case of any organic products imported from third countries, as well as for information and educational purposes. The model of the organic production logo of the European Union should be set out. (78) However, in order not to mislead consumers as to the organic nature of the entire product, it is appropriate to limit the use of that logo to products which contain only, or almost only, organic ingredients. It should therefore not be allowed to use it in the labelling of in-conversion products or processed products of which less than 95 % by weight of their ingredients of agricultural origin are organic. (79) To avoid any possible confusion among consumers about the Union or non-Union origin of a product, whenever the organic production logo of the European Union is used, consumers should be informed about the place where the agricultural raw materials of which the product is composed have been farmed. In that context, it should be allowed to refer to aquaculture in the label of products from organic aquaculture instead of referring to agriculture. (80) In order to provide clarity for consumers, and to ensure that the appropriate information is communicated to them, the power to adopt certain acts should be delegated to the Commission in respect of laying down additional rules on the labelling of organic products and amending the list of terms referring to organic production set out in this Regulation, the organic production logo of the European Union, and the rules relating thereto. (81) Certain products or substances used in plant protection products or as fertilisers should not fall within the scope of this Regulation and should therefore, in principle, not be subject to the rules of this Regulation, including the rules on labelling. However, since those products and substances play an important role in organic agriculture and their use in organic production is subject to authorisation under this Regulation, and since certain uncertainties as regards their labelling appeared in practice, in particular as regards the use of terms referring to organic production, it should be made clear that where such products or substances are authorised for use in organic production in accordance with this Regulation, they may be labelled accordingly. (82) Organic production is only credible if accompanied by effective verification and controls at all stages of production, processing and distribution. (83) Specific requirements for operators should be laid down to ensure compliance with this Regulation. In particular, provisions should be made for the notification of operator’s activities to the competent authorities and for a certification system to identify the operators that comply with the rules governing organic production and the labelling of organic products. Those provisions should in principle also apply to any subcontractors of the operators concerned, unless the subcontracting activity is entirely integrated within the main activity of the subcontracting operator, and is controlled in that context. The transparency of the certification system should be ensured by requiring Member States to make public the lists of operators that have notified their activities, and any fees that may be collected in relation to the controls performed for the verification of compliance with the rules governing organic production. (84) Small retail shops not selling organic products other than prepacked organic products present a relatively low risk of non-compliance with organic production rules, and they should not face disproportionate burdens for selling organic products. They should therefore not be subject to the notification and certification obligations, but should remain subject to official controls performed for the verification of compliance with the rules governing organic production and the labelling of organic products. Equally, small retail shops selling unpacked organic products should be subject to official controls, but in order to facilitate the marketing of organic products, Member States should have the possibility of exempting such shops from the obligation to certify their activities. (85) Small farmers and operators that produce algae or aquaculture animals in the Union individually face relatively high inspection costs and administrative burdens linked to organic certification. A system of group certification should be allowed in order to reduce the inspection and certification costs and the associated administrative burdens, strengthen local networks, contribute to better market outlets and ensure a level playing field with operators in third countries. For that reason, the concept of ‘group of operators’ should be introduced and defined, and rules should be established that reflect the needs and resource capacity of small farmers and operators. (86) In order to ensure the effectiveness, efficiency and transparency of the organic production and of the labelling of organic products, the power to adopt certain acts should be delegated to the Commission in respect of the requirements for keeping records by operators or groups of operators and the model of the certificate of compliance. (87) In order to ensure that the certification of groups of operators is done effectively and efficiently, the power to adopt certain acts should be delegated to the Commission in respect of the responsibilities of the individual members of groups of operators, the criteria to determine the geographical proximity of their members, and the set-up and functioning of their systems for internal controls. (88) Organic production is subject to official controls and to other official activities carried out in accordance with Regulation (EU) 2017/625 to verify compliance with the rules on organic production and the labelling of organic products. However, except as otherwise provided for in this Regulation, rules should apply to organic production in addition to those which are laid down in that Regulation as regards official controls and actions by competent authorities, and, where appropriate, by control authorities and control bodies, as regards actions to be taken by operators and groups of operators, as regards the delegation of certain official control tasks or certain tasks related to other official activities and their supervision, and as regards actions in cases of suspected or established non-compliance, including the prohibition against marketing products as organic or in-conversion products where the established non-compliance affects the integrity of those products. (89) In order to ensure a uniform approach on their territories, it should be solely up to the competent authorities to provide for a catalogue of measures to be taken in cases of suspected or established non-compliance. (90) Provisions on the exchange of certain relevant information among competent authorities, control authorities, control bodies and certain other bodies and on the action of such authorities and bodies, additional to the provisions of Regulation (EU) 2017/625, should be laid down in this Regulation. (91) In order to support the performance of official controls and other official activities to verify compliance with this Regulation, the power to adopt certain acts should be delegated to the Commission in respect of specific criteria and conditions for the performance of official controls conducted to ensure the traceability at all stages of production, preparation and distribution, and compliance with this Regulation and in respect of additional elements to be taken into account in the determination, based on practical experience, of the likelihood of non-compliance. (92) In order to support the performance of official controls and other official activities to verify compliance with this Regulation, the power to adopt certain acts should be delegated to the Commission in respect of the conditions for the delegation of official control tasks and tasks related to other official activities to control bodies, in addition to the conditions laid down in this Regulation. (93) The experience with the arrangements for the import of organic products into the Union under Regulation (EC) No 834/2007 has shown that there is a need to revise those arrangements in order to respond to consumer expectations that imported organic products meet standards as high as those of the Union, as well as in order to better ensure the access of Union organic products to the international market. In addition, it is necessary to provide clarity regarding the rules applicable to export of organic products, in particular by establishing organic export certificates. (94) The provisions governing the import of products that comply with the Union production and labelling rules, in respect of which operators have been subject to the control of control authorities and control bodies recognised by the Commission to carry out in third countries controls and certification in the field of organic production, should be further reinforced. In particular, requirements concerning the accreditation bodies which accredit control bodies for the purposes of import of compliant organic products into the Union should be laid down in order to ensure a level playing field for the supervision of the control bodies by the Commission. Furthermore, it is necessary to provide for the possibility for the Commission to contact directly the accreditation bodies and competent authorities in third countries to render the supervision of control authorities and control bodies respectively more efficient. In the case of products imported from third countries or the outermost regions of the Union with specific climatic and local conditions, it is appropriate to provide for the possibility for the Commission to grant specific authorisations for the use of products and substances in organic production. (95) It should remain possible for organic products to have access to the Union market where such products do not comply with the Union rules on organic production but come from third countries whose organic production and control systems have been recognised as equivalent to those of the Union. However, the recognition of equivalence of third countries, as laid down in Regulation (EC) No 834/2007, should only be granted through international agreements between the Union and those third countries, where a reciprocal recognition of equivalence would be also pursued for the Union. (96) Third countries recognised for the purpose of equivalence under Regulation (EC) No 834/2007 should continue to be recognised as such under this Regulation, for a limited period necessary to ensure a smooth transition to the scheme of recognition through an international agreement, provided that they continue to ensure that their organic production and control rules are equivalent to the relevant Union rules in force and that they fulfil all requirements relating to the supervision of their recognition by the Commission. That supervision should be based in particular on the annual reports those recognised third countries send to the Commission. (97) The experience with the scheme of control authorities and control bodies recognised by the Commission to carry out controls and to issue certificates in third countries for the purpose of importing products, which provides equivalent guarantees, shows that the rules applied by those authorities and bodies differ, and it could be difficult to consider such rules as equivalent to the respective Union rules. Furthermore, the multiplication of standards for control authorities and control bodies hampers adequate supervision by the Commission. Therefore, that scheme of recognition of equivalence should be abolished. However, those control authorities and control bodies should be given sufficient time so that they can prepare themselves to obtain recognition for the purposes of import of products that comply with Union rules. Furthermore, the new rules for the recognition of control authorities and control bodies for the purpose of importing compliant products should already apply from the date of entry into force of this Regulation, in order to allow the Commission to prepare for the recognition of such control authorities and control bodies from the date of application of this Regulation. (98) The placing of any product on the market as an organic product, where that product has been imported into the Union under any of the import arrangements provided for in this Regulation, should be subject to the availability of the information necessary to ensure the traceability of the product on the food chain. (99) In order to ensure fair competition among operators, the power to adopt certain acts should be delegated to the Commission in respect of the documents intended for customs authorities in third countries, in particular organic export certificates. (100) In order to ensure the transparency of the recognition and supervision procedure for control authorities and control bodies within the context of import of compliant organic products and the effectiveness, efficiency and transparency of the controls of imported products, the power to adopt certain acts should be delegated to the Commission in respect of further criteria for recognition of control authorities and control bodies in the context of import of organic products that comply with this Regulation, as well as further criteria for the withdrawal of such recognition, in respect of the exercise of the supervision of the control authorities and control bodies recognised by the Commission and in respect of the controls and other actions to be performed by control authorities and control bodies for that purpose. (101) Where serious or repetitive infringements as regards the certification or the controls and actions under this Regulation have been detected, and where the control authority or control body concerned fails to take appropriate and timely remedial action in reaction to a request by the Commission, the recognition of that control authority or control body should be withdrawn without delay. (102) In order to ensure the management of the list of third countries recognised for the purpose of equivalence under Regulation (EC) No 834/2007, the power to adopt certain acts should be delegated to the Commission in respect of the information to be sent by those recognised third countries which is necessary for the supervision of their recognition and the exercise of that supervision by the Commission. (103) Provision should be made for ensuring that the movement of organic products that comply with this Regulation and have been subject to a control in one Member State cannot be restricted in another Member State. (104) For the purpose of obtaining reliable information for the implementation of this Regulation, Member States should regularly provide the Commission with the necessary information. For reasons of clarity and transparency, Member States should keep updated lists of competent authorities, control authorities and control bodies. The lists of control authorities and control bodies should be made public by the Member States and published by the Commission. (105) In view of the phasing out of the derogations concerning the use of non-organic plant reproductive material, non-organically reared poultry, and non-organic livestock for breeding purposes, the Commission should consider the availability of such material in organic form on the market in the Union. To that end, and on the basis of the data on the availability of organic material collected through the database and systems set up by Member States, five years after the date of application of this Regulation, the Commission should present a report to the European Parliament and the Council on the availability and reasons of a possible limited access of organic operators to such material. (106) In view of the phasing out of the derogations concerning the use of non-organic protein feed for poultry and porcine animals, and on the basis of the data provided every year by Member States on the availability of such protein feed in organic form on the market in the Union, five years after the date of application of this Regulation, the Commission should present a report to the European Parliament and to the Council on the availability of and reasons for a possible limited access of organic operators to such organic protein feed. (107) In order to take into account the evolution of availability on the market of organic plant reproductive material, organic animals and organic protein feed for poultry and porcine animals, the power to adopt certain acts should be delegated to the Commission in respect of ending or extending derogations and authorisations concerning the use of non-organic plant reproduction material, non-organic animals and non-organic protein feed for poultry and porcine animals. (108) It is necessary to lay down measures to ensure a smooth transition to the legal framework governing the import of organic and in-conversion products into the Union as modified by this Regulation. (109) Furthermore, a time limit for the expiry of the recognition of control authorities and control bodies for the purpose of equivalence granted under Regulation (EC) No 834/2007 should be set, and provisions to address the situation up to the expiry of their recognition should be laid down. Provisions should also be laid down regarding applications from third countries for recognition for the purpose of equivalence which have been submitted under Regulation (EC) No 834/2007 and which are pending on the date of entry into force of this Regulation. (110) In order to ensure the management of the list of control authorities and control bodies recognised for the purpose of equivalence under Regulation (EC) No 834/2007, the power to adopt certain acts should be delegated to the Commission in respect of the information that those control authorities and control bodies should send for the purpose of the supervision of their recognition and in respect of the exercise of that supervision by the Commission. (111) In order to facilitate the completion of the examination of applications from third countries for recognition for the purpose of equivalence that are pending on the date of entry into force of this Regulation, the power to adopt certain acts should be delegated to the Commission in respect of the procedural rules necessary for the examination of the pending applications from third countries. (112) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the documents that are to be supplied for the purpose of recognising a previous period as being part of the conversion period, as regards the minimum period for feeding of suckling animals with maternal milk and certain technical rules for livestock housing and husbandry practices, as regards detailed rules per species or per group of species of alga and aquaculture animal on the stocking density and on the specific characteristics for production systems and containment systems, as regards techniques authorised in the processing of food and feed products, as regards the authorisation of the products and substances that may be used in organic production in general, and in the production of processed organic food in particular, as well as the withdrawal of such authorisations, and as regards the procedures for the authorisation and the lists of such products and substances and, where appropriate, the description, compositional requirement and conditions for the use of such products. (113) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the technical details for establishing and maintaining the databases that list the available organic or in-conversion plant reproductive material obtained by the organic production method, as regards the technical details for establishing and maintaining the systems for making available data on organic or in-conversion plant reproductive material or organic animals or organic aquaculture juveniles and the specifications for the collection of data for that purpose, as regards the arrangements for operators’ participation in those systems, and as regards details concerning the information to be provided by Member State as regards derogations from the use of organic plant reproductive material, organic animals and organic feed and as regards the availability on the market of certain organic products. (114) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the measures to be adopted and reviewed by operators to identify and avoid risk of contamination of organic production and products with non-authorised products and substances, as regards the procedural steps to be taken in the case of a suspicion of non-compliance and the relevant documents, as regards the methodology on detection and evaluation of the presence of non-authorised products and substances, and as regards the details and format of the information to be transmitted by Member States to the Commission and other Member States concerning results of investigations on the presence of non-authorised products or substances. (115) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards detailed requirements for the labelling and advertising of certain in-conversion products, as regards the practical arrangements for the use, presentation, composition and size of the indications referring to the code numbers of control authorities and control bodies and the use, presentation, composition and size of the indication of the place where the agricultural raw materials have been farmed, as regards the assignment of code numbers to control authorities and control bodies and as regards the indication of the place where the agricultural raw materials have been farmed. (116) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the details and specifications regarding the format and technical means by which operators and groups of operators are to notify their activities to the competent authorities, as regards the arrangements for the publication of the lists of such operators and groups of operators, as regards the procedures and the arrangements for the publication of the fees that may be collected in relation to the controls, as regards details and specifications regarding the form of the certificate for operators and groups of operators and the technical means by which it is issued, as regards the composition and dimensions of groups of operators, as regards the relevant documents and record-keeping systems, as regards the system for internal traceability and the list of operators, and as regards the exchange of information between groups of operators and competent authorities, control authorities or control bodies and the exchange of information between the Member States and the Commission. (117) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the minimum percentage of all official controls to be carried out without prior notice and the minimum percentage of additional controls, as well as the minimum number of samples to be taken and of operators to be controlled within a group of operators, as regards the records for demonstrating compliance, as regards the declarations and other communications that are necessary for official controls, as regards the relevant practical measures for ensuring compliance, as regards uniform arrangements for the cases where competent authorities are to take measures in relation to suspected or established non-compliance, as regards the information to be provided in the case of suspected or established non-compliance, as regards the recipients of such information, and as regards the procedures for the provision of such information, including the functionalities of the computer system used. (118) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the content of certificates of inspection issued by third countries, as regards the procedure to be followed for the issuance and verification of such certificates, as regards the technical means by which such certificates are issued, as regards the recognition of control authorities and control bodies competent to carry out controls and to issue organic certificate in third countries, as well as the withdrawal of such recognition, as regards the establishment of the list of those control authorities and control bodies, as regards rules to ensure the application of measures in relation to cases of suspected or established non-compliance, in particular those cases that affect the integrity of imported organic or in-conversion products, as regards the establishment of a list of third countries recognised under Article 33(2) of Regulation (EC) No 834/2007 and the amendment of that list, and as regards rules to ensure the application of measures in relation to cases of suspected or established non-compliance, in particular those cases that affect the integrity of organic or in-conversion products imported from those countries. (119) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the system to be used for transmitting the information necessary for the implementation and monitoring of this Regulation, as regards the details of the information to be transmitted and the date by which that information is to be transmitted, and as regards the establishment of the list of control authorities and control bodies recognised under Article 33(3) of Regulation (EC) No 834/2007 and the amendment of that list. (120) The implementing powers conferred on the Commission should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (31). (121) The Commission should be empowered to adopt immediately applicable implementing acts, where, in duly justified cases relating to unfair practices or practices which are incompatible with the principles and rules on organic production, the protection of consumers’ confidence or the protection of fair competition between operators, imperative grounds of urgency so require, to ensure the application of measures in relation to cases of suspected or established non-compliance under the control of recognised control authorities or control bodies. (122) Provision should be made to allow the exhaustion after the date of application of this Regulation of stocks of products which have been produced in accordance with Regulation (EC) No 834/2007 before that date. (123) Since the objectives of this Regulation, in particular fair competition and the proper functioning of the internal market in organic products, as well as ensuring consumer confidence in those products and in the organic production logo of the European Union, cannot be sufficiently achieved by the Member States themselves but can rather, by reason of the required harmonisation of the rules on organic production, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (124) It is appropriate to provide for a date of application of this Regulation that would give the possibility to operators to adapt to the new requirements, HAVE ADOPTED THIS REGULATION: CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter This Regulation establishes the principles of organic production and lays down the rules concerning organic production, related certification and the use of indications referring to organic production in labelling and advertising, as well as rules on controls additional to those laid down in Regulation (EU) 2017/625. Article 2 Scope 1. This Regulation applies to the following products originating from agriculture, including aquaculture and beekeeping, as listed in Annex I to the TFEU and to products originating from those products, where such products are, or are intended to be, produced, prepared, labelled, distributed, placed on the market, imported into or exported from the Union: (a) live or unprocessed agricultural products, including seeds and other plant reproductive material; (b) processed agricultural products for use as food; (c) feed. This Regulation also applies to certain other products closely linked to agriculture listed in Annex I to this Regulation, where they are, or are intended to be, produced, prepared, labelled, distributed, placed on the market, imported into or exported from the Union. 2. This Regulation applies to any operator involved, at any stage of production, preparation and distribution, in activities relating to the products referred to in paragraph 1. 3. Mass catering operations carried out by a mass caterer as defined in point (d) of Article 2(2) of Regulation (EU) No 1169/2011 are not subject to this Regulation except as set out in this paragraph. Member States may apply national rules or, in the absence thereof, private standards, on the production, labelling and control of products originating from mass catering operations. The organic production logo of the European Union shall not be used in the labelling, the presentation or the advertising of such products, and shall not be used to advertise the mass caterer. 4. Except where otherwise provided, this Regulation applies without prejudice to related Union legislation, in particular, legislation in the fields of safety of the food chain, animal health and welfare, plant health and plant reproductive material. 5. This Regulation applies without prejudice to other specific Union law relating to the placing of products on the market and, in particular, to Regulation (EU) No 1308/2013 of the European Parliament and of the Council (32) and to Regulation (EU) No 1169/2011. 6. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending the list of products set out in Annex I by adding further products to the list, or by amending those added entries. Only products which are closely linked to agricultural products shall be eligible for inclusion in that list. Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘organic production’ means the use, including during the conversion period referred to in Article 10, of production methods that comply with this Regulation at all stages of production, preparation and distribution; (2) ‘organic product’ means a product resulting from organic production, other than a product produced during the conversion period referred to in Article 10. The products of hunting or fishing of wild animals are not considered as organic products; (3) ‘agricultural raw material’ means an agricultural product that has not been subjected to any operation of preservation or processing; (4) ‘preventive measures’ means measures that are to be taken by operators at every stage of production, preparation and distribution in order to ensure the preservation of biodiversity and soil quality, measures for the prevention and control of pests and diseases and measures that are to be taken to avoid negative effects on the environment, animal health and plant health; (5) ‘precautionary measures’ means measures that are to be taken by operators at every stage of production, preparation, and distribution to avoid contamination with products or substances that are not authorised for use in organic production in accordance with this Regulation, and to avoid the commingling of organic products with non-organic products; (6) ‘conversion’ means the transition from non-organic to organic production within a given period, during which the provisions of this Regulation concerning organic production apply; (7) ‘in-conversion product’ means a product that is produced during the conversion period referred to in Article 10; (8) ‘holding’ means all the production units operated under single management for the purpose of producing live or unprocessed agricultural products, including products originating from aquaculture and beekeeping, referred to in point (a) of Article 2(1) or products listed in Annex I other than essential oils and yeast; (9) ‘production unit’ means all assets of a holding, such as primary production premises, land parcels, pasturages, open air areas, livestock buildings or parts thereof, hives, fish ponds, containment systems and sites for algae or aquaculture animals, rearing units, shore or seabed concessions, and premises for the storage of crops, of crop products, of algae products, of animal products, of raw materials and of any other relevant inputs managed as described in point (10), point (11) or point (12); (10) ‘organic production unit’ means a production unit, excluding during the conversion period referred to in Article 10, which is managed in compliance with the requirements applicable to organic production; (11) ‘in-conversion production unit’ means a production unit, during the conversion period referred to in Article 10, which is managed in compliance with the requirements applicable to organic production; it may be constituted of land parcels or other assets for which the conversion period referred to in Article 10 starts at different moments in time; (12) ‘non-organic production unit’ means a production unit which is not managed in compliance with the requirements applicable to organic production; (13) ‘operator’ means the natural or legal person responsible for ensuring that this Regulation is complied with at every stage of production, preparation and distribution that are under that person’s control; (14) ‘farmer’ means a natural or legal person, or a group of natural or legal persons, regardless of the legal status of that group and its members under national law, who exercises an agricultural activity; (15) ‘agricultural area’ means agricultural area as defined in point (e) of Article 4(1) of Regulation (EU) No 1307/2013; (16) ‘plants’ means plants as defined in point (5) of Article 3 of Regulation (EC) No 1107/2009; (17) ‘plant reproductive material’ means plants and all parts of plants, including seeds, at any stage of growth that are capable of, and intended for, producing entire plants; (18) ‘organic heterogeneous material’ means a plant grouping within a single botanical taxon of the lowest known rank which: (a) presents common phenotypic characteristics; (b) is characterised by a high level of genetic and phenotypic diversity between individual reproductive units, so that that plant grouping is represented by the material as a whole, and not by a small number of units; (c) is not a variety within the meaning of Article 5(2) of Council Regulation (EC) No 2100/94 (33); (d) is not a mixture of varieties; and (e) has been produced in accordance with this Regulation; (19) ‘organic variety suitable for organic production’ means a variety as defined in Article 5(2) of Regulation (EC) No 2100/94 which: (a) is characterised by a high level of genetic and phenotypical diversity between individual reproductive units; and (b) results from organic breeding activities referred to in point 1.8.4 of Part I of Annex II to this Regulation; (20) ‘mother plant’ means an identified plant from which plant reproductive material is taken for the reproduction of new plants; (21) ‘generation’ means a group of plants constituting a single step in the line of descent of plants; (22) ‘plant production’ means production of agricultural crop products including harvesting of wild plant products for commercial purposes; (23) ‘plant products’ means plant products as defined in point (6) of Article 3 of Regulation (EC) No 1107/2009; (24) ‘pest’ means a pest as defined in Article 1(1) of Regulation (EU) 2016/2031 of the European Parliament and of the Council (34); (25) ‘biodynamic preparations’ means mixtures traditionally used in biodynamic farming; (26) ‘plant protection products’ means the products referred to in Article 2 of Regulation (EC) No 1107/2009; (27) ‘livestock production’ means the production of domestic or domesticated terrestrial animals, including insects; (28) ‘veranda’ means an additional, roofed, uninsulated, outdoor part of a building intended for poultry, the longest side usually being equipped with wire fencing or netting, with an outdoor climate, natural and, where necessary, artificial illumination, and a littered floor; (29) ‘pullets’ means young animals of the Gallus gallus species that are of an age of less than 18 weeks; (30) ‘laying hens’ means animals of the Gallus gallus species that are intended for the production of eggs for consumption and that are of an age of at least 18 weeks; (31) ‘usable area’ means usable area as defined in point (d) of Article 2(2) of Council Directive 1999/74/EC (35); (32) ‘aquaculture’ means aquaculture as defined in point (25) of Article 4(1) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council (36); (33) ‘aquaculture products’ means aquaculture products as defined in point (34) of Article 4(1) of Regulation (EU) No 1380/2013; (34) ‘closed recirculation aquaculture facility’ means a facility on land or in a vessel where aquaculture takes place within an enclosed environment involving the recirculation of water and which depends on permanent external energy input to stabilise the environment for the aquaculture animals; (35) ‘energy from renewable sources’ means energy from renewable non-fossil sources such as wind, solar, geothermal, wave, tidal, hydropower, landfill gas, sewage treatment plant gas and biogases; (36) ‘hatchery’ means a place for the breeding, hatching and rearing through the early life stages of aquaculture animals, in particular finfish and shellfish; (37) ‘nursery’ means a place where an intermediate aquaculture production system is applied between the hatchery and grow-out stages. The nursery stage is completed within the first third of the production cycle, with the exception of species undergoing a smoltification process; (38) ‘water pollution’ means pollution as defined in point (33) of Article 2 of Directive 2000/60/EC and in point (8) of Article 3 of Directive 2008/56/EC of the European Parliament and of the Council (37), in the waters to which each of those Directives applies; (39) ‘polyculture’ means the rearing in aquaculture of two or more species, usually from different trophic levels, in the same culture unit; (40) ‘production cycle’ means the lifespan of an aquaculture animal or alga, from the earliest life stage (fertilised eggs, in the case of aquaculture animals) to harvesting; (41) ‘locally grown species’ means aquaculture species which are neither alien nor locally absent species within the meaning of points (6) and (7), respectively, of Article 3 of Council Regulation (EC) No 708/2007 (38), as well as the species listed in Annex IV to that Regulation; (42) ‘veterinary treatment’ means all courses of a curative or preventive treatment against an occurrence of a specific disease; (43) ‘veterinary medicinal product’ means a veterinary medicinal product as defined in point (2) of Article 1 of Directive 2001/82/EC of the European Parliament and of the Council (39); (44) ‘preparation’ means the operations of preserving or processing of organic or in-conversion products, or any other operation that is carried out on an unprocessed product without altering the initial product, such as slaughtering, cutting, cleaning or milling, as well as packaging, labelling or alterations made to the labelling relating to organic production; (45) ‘food’ means food as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (40); (46) ‘feed’ means feed as defined in point (4) of Article 3 of Regulation (EC) No 178/2002; (47) ‘feed materials’ mean feed materials as defined in point (g) of Article 3(2) of Regulation (EC) No 767/2009 of the European Parliament and of the Council (41); (48) ‘placing on the market’ means placing on the market as defined in point (8) of Article 3 of Regulation (EC) No 178/2002; (49) ‘traceability’ means the ability to trace and follow food, feed or any product referred to in Article 2(1), and any substance intended or expected to be incorporated into food, feed or any product referred to in Article 2(1), through all stages of production, preparation and distribution; (50) ‘stage of production, preparation and distribution’ means any stage from the primary production of an organic product through its storage, processing, transport, and sale or supply to the final consumer, including, where relevant, labelling, advertising, import, export and subcontracting activities; (51) ‘ingredient’ means an ingredient as defined in point (f) of Article 2(2) of Regulation (EU) No 1169/2011 or, for products other than food, any substance or product used in the manufacture or preparation of products that is still present in the finished product, even in altered form; (52) ‘labelling’ means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a product that are placed on any packaging, document, notice, label, ring or collar that accompanies or refers to that product; (53) ‘advertising’ means any presentation of products to the public, by any means other than a label, that is intended or is likely to influence and shape attitudes, beliefs and behaviours in order to directly or indirectly promote the sale of products; (54) ‘competent authorities’ means competent authorities as defined in point (3) of Article 3 of Regulation (EU) 2017/625; (55) ‘control authority’ means an organic control authority as defined in point (4) of Article 3 of Regulation (EU) 2017/625, or an authority recognised by the Commission or by a third country recognised by the Commission for the purposes of carrying out controls in third countries for the import of organic and in-conversion products into the Union; (56) ‘control body’ means a delegated body as defined in point (5) of Article 3 of Regulation (EU) 2017/625, or a body recognised by the Commission or by a third country recognised by the Commission for the purposes of carrying out controls in third countries for the import of organic and in-conversion products into the Union; (57) ‘non-compliance’ means non-compliance with this Regulation or non-compliance with the delegated or implementing acts adopted in accordance with this Regulation; (58) ‘genetically modified organism’ or ‘GMO’ means a genetically modified organism as defined in point (2) of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council (42) which is not obtained through the techniques of genetic modification listed in Annex I.B to that Directive; (59) ‘produced from GMOs’ means derived in whole or in part from GMOs but not containing or consisting of GMOs; (60) ‘produced by GMOs’ means derived by using a GMO as the last living organism in the production process, but not containing or consisting of GMOs nor produced from GMOs; (61) ‘food additive’ means a food additive as defined in point (a) of Article 3(2) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council (43); (62) ‘feed additives’ mean feed additives as defined in point (a) of Article 2(2) of Regulation (EC) No 1831/2003 of the European Parliament and of the Council (44); (63) ‘engineered nanomaterial’ means an engineered nanomaterial as defined in point (f) of Article 3(2) of Regulation (EU) 2015/2283 of the European Parliament and of the Council (45); (64) ‘equivalence’ means meeting the same objectives and principles by applying rules which ensure the same level of assurance of conformity; (65) ‘processing aid’ means a processing aid as defined in point (b) of Article 3(2) of Regulation (EC) No 1333/2008 for food and in point (h) of Article 2(2) of Regulation (EC) No 1831/2003 for feed; (66) ‘food enzyme’ means a food enzyme as defined in point (a) of Article 3(2) of Regulation (EC) No 1332/2008 of the European Parliament and of the Council (46); (67) ‘ionising radiation’ means ionising radiation as defined in point (46) of Article 4 of Council Directive 2013/59/Euratom (47); (68) ‘prepacked food’ means prepacked food as defined in point (e) of Article 2(2) of Regulation (EU) No 1169/2011; (69) ‘poultry house’ means a fixed or mobile building for accommodating flocks of poultry, which includes all surfaces covered by roofs, including a veranda; the house may be subdivided into separate compartments, each accommodating a single flock; (70) ‘soil-related crop cultivation’ means production in living soil or in soil that is mixed or fertilised with materials and products that are allowed in organic production in connection with the subsoil and bedrock; (71) ‘unprocessed products’ means unprocessed products as defined in point (n) of Article 2(1) of Regulation (EC) No 852/2004 of the European Parliament and of the Council (48), irrespective of packaging or labelling operations; (72) ‘processed products’ means processed products as defined in point (o) of Article 2(1) of Regulation (EC) No 852/2004, irrespective of packaging or labelling operations; (73) ‘processing’ means processing as defined in point (m) of Article 2(1) of Regulation (EC) No 852/2004; this includes the use of substances referred to in Articles 24 and 25 of this Regulation but does not include packaging or labelling operations; (74) ‘integrity of organic or in-conversion products’ means the fact that the product does not exhibit non-compliance which: (a) in any stage of production, preparation and distribution affects the organic or in-conversion characteristics of the product; or (b) is repetitive or intentional; (75) ‘pen’ means an enclosure that includes a part in which animals are provided with protection from adverse weather conditions. CHAPTER II OBJECTIVES AND PRINCIPLES OF ORGANIC PRODUCTION Article 4 Objectives Organic production shall pursue the following general objectives: (a) contributing to protection of the environment and the climate; (b) maintaining the long-term fertility of soils; (c) contributing to a high level of biodiversity; (d) substantially contributing to a non-toxic environment; (e) contributing to high animal welfare standards and, in particular, to meeting the species-specific behavioural needs of animals; (f) encouraging short distribution channels and local production in the various areas of the Union; (g) encouraging the preservation of rare and native breeds in danger of extinction; (h) contributing to the development of the supply of plant genetic material adapted to the specific needs and objectives of organic agriculture; (i) contributing to a high level of biodiversity, in particular by using diverse plant genetic material, such as organic heterogeneous material and organic varieties suitable for organic production; (j) fostering the development of organic plant breeding activities in order to contribute to favourable economic perspectives of the organic sector. Article 5 General principles Organic production is a sustainable management system that is based on the following general principles: (a) respect for nature’s systems and cycles and the sustainment and enhancement of the state of the soil, the water and the air, of the health of plants and animals, and of the balance between them; (b) the preservation of natural landscape elements, such as natural heritage sites; (c) the responsible use of energy and natural resources, such as water, soil, organic matter and air; (d) the production of a wide variety of high-quality food and other agricultural and aquaculture products that respond to consumers’ demand for goods that are produced by the use of processes that do not harm the environment, human health, plant health or animal health and welfare; (e) ensuring the integrity of organic production at all stages of the production, processing and distribution of food and feed; (f) the appropriate design and management of biological processes, based on ecological systems and using natural resources which are internal to the management system, using methods that: (i) use living organisms and mechanical production methods; (ii) practice soil-related crop cultivation and land-related livestock production, or practice aquaculture which complies with the principle of the sustainable exploitation of aquatic resources; (iii) exclude the use of GMOs, products produced from GMOs, and products produced by GMOs, other than veterinary medicinal products; (iv) are based on risk assessment and the use of precautionary measures and preventive measures, where appropriate; (g) the restriction of the use of external inputs; where external inputs are required or the appropriate management practices and methods referred to in point (f) do not exist, the external inputs shall be limited to: (i) inputs from organic production; in the case of plant reproductive material, priority shall be given to varieties selected for their ability to meet the specific needs and objectives of organic agriculture; (ii) natural or naturally-derived substances; (iii) low solubility mineral fertilisers; (h) the adaptation of the production process, where necessary and within the framework of this Regulation, to take account of the sanitary status, regional differences in the ecological balance, climatic and local conditions, stages of development and specific husbandry practices; (i) the exclusion from the whole organic food chain of animal cloning, of rearing artificially induced polyploid animals and of ionising radiation; (j) the observance of a high level of animal welfare respecting species-specific needs. Article 6 Specific principles applicable to agricultural activities and aquaculture As regards agricultural activities and aquaculture, organic production shall, in particular, be based on the following specific principles: (a) the maintenance and enhancement of soil life and natural soil fertility, soil stability, soil water retention and soil biodiversity, preventing and combating loss of soil organic matter, soil compaction and soil erosion, and the nourishing of plants primarily through the soil ecosystem; (b) the limitation of the use of non-renewable resources and external inputs to a minimum; (c) the recycling of waste and by-products of plant and animal origin as input in plant and livestock production; (d) the maintenance of plant health by preventive measures, in particular the choice of appropriate species, varieties or heterogeneous material resistant to pests and diseases, appropriate crop rotations, mechanical and physical methods and protection of the natural enemies of pests; (e) the use of seeds and animals with a high degree of genetic diversity, disease resistance and longevity; (f) in the choosing of plant varieties, having regard to the particularities of the specific organic production systems, focussing on agronomic performance, disease resistance, adaptation to diverse local soil and climate conditions and respect for the natural crossing barriers; (g) the use of organic plant reproductive material, such as plant reproductive material of organic heterogeneous material and of organic varieties suitable for organic production; (h) the production of organic varieties through natural reproductive ability and focussing on containment within natural crossing barriers; (i) without prejudice to Article 14 of Regulation (EC) No 2100/94 and to the national plant variety rights granted under Member States’ national law, the possibility for farmers to use plant reproductive material obtained from their own farms in order to foster genetic resources adapted to the special conditions of organic production; (j) in the choosing of animal breeds, having regard to a high degree of genetic diversity, the capacity of animals to adapt to local conditions, their breeding value, their longevity, their vitality and their resistance to disease or health problems; (k) the practice of site-adapted and land-related livestock production; (l) the application of animal husbandry practices which enhance the immune system and strengthen the natural defence against diseases, including regular exercise and access to open air areas and pastures; (m) the feeding of livestock with organic feed composed of agricultural ingredients resulting from organic production and of natural non-agricultural substances; (n) the production of organic livestock products derived from animals that have been raised on organic holdings throughout their lives since birth or hatching; (o) the continuing health of the aquatic environment and the quality of surrounding aquatic and terrestrial ecosystems; (p) the feeding of aquatic organisms with feed from sustainably exploited fisheries in accordance with Regulation (EU) No 1380/2013 or with organic feed composed of agricultural ingredients resulting from organic production, including organic aquaculture, and of natural non-agricultural substances; (q) avoiding any endangerment of species of conservation interest that might arise from organic production. Article 7 Specific principles applicable to the processing of organic food The production of processed organic food shall be based, in particular, on the following specific principles: (a) the production of organic food from organic agricultural ingredients; (b) the restriction of the use of food additives, of non-organic ingredients with mainly technological and sensory functions, and of micronutrients and processing aids, so that they are used to a minimum extent and only in cases of essential technological need or for particular nutritional purposes; (c) the exclusion of substances and processing methods that might be misleading as regards the true nature of the product; (d) the processing of organic food with care, preferably through the use of biological, mechanical and physical methods; (e) the exclusion of food containing, or consisting of, engineered nanomaterials. Article 8 Specific principles applicable to the processing of organic feed The production of processed organic feed shall be based, in particular, on the following specific principles: (a) the production of organic feed from organic feed materials; (b) the restriction of the use of feed additives and processing aids, so that they are used to a minimum extent and only in cases of essential technological or zootechnical needs or for particular nutritional purposes; (c) the exclusion of substances and processing methods that might be misleading as regards the true nature of the product; (d) the processing of organic feed with care, preferably through the use of biological, mechanical and physical methods. CHAPTER III PRODUCTION RULES Article 9 General production rules 1. Operators shall comply with the general production rules laid down in this Article. 2. The entire holding shall be managed in compliance with the requirements of this Regulation that apply to organic production. 3. For the purposes and uses referred to in Articles 24 and 25 and in Annex II, only products and substances that have been authorised pursuant to those provisions may be used in organic production, provided that their use in non-organic production has also been authorised in accordance with the relevant provisions of Union law and, where applicable, in accordance with national provisions based on Union law. The following products and substances referred to in Article 2(3) of Regulation (EC) No 1107/2009 shall be allowed for use in organic production, provided that they are authorised pursuant to that Regulation: (a) safeners, synergists and co-formulants as components of plant protection products; (b) adjuvants that are to be mixed with plant protection products. The use in organic production of products and substances for purposes other than those covered by this Regulation shall be allowed, provided that their use complies with the principles laid down in Chapter II. 4. Ionising radiation shall not be used in the treatment of organic food or feed, and in the treatment of raw materials used in organic food or feed. 5. The use of animal cloning, and the rearing of artificially induced polyploid animals, shall be prohibited. 6. Preventive and precautionary measures shall be taken, where appropriate, at every stage of production, preparation and distribution. 7. Notwithstanding paragraph 2, a holding may be split into clearly and effectively separated production units for organic, in-conversion and non-organic production, provided that for the non-organic production units: (a) as regards livestock, different species are involved; (b) as regards plants, different varieties that can be easily differentiated are involved. As regards algae and aquaculture animals, the same species may be involved, provided that there is a clear and effective separation between the production sites or units. 8. By way of derogation from point (b) of paragraph 7, in the case of perennial crops which require a cultivation period of at least three years, different varieties that cannot be easily differentiated, or the same varieties, may be involved, provided that the production in question is within the context of a conversion plan, and provided that the conversion of the last part of the area related to the production in question to organic production begins as soon as possible and is completed within a maximum of five years. In such cases: (a) the farmer shall notify the competent authority, or, where appropriate, the control authority or the control body, of the start of harvest of each of the products concerned at least 48 hours in advance; (b) upon completion of the harvest, the farmer shall inform the competent authority, or, where appropriate, the control authority or the control body, of the exact quantities harvested from the units concerned and of the measures taken to separate the products; (c) the conversion plan and the measures to be taken to ensure the effective and clear separation shall be confirmed each year by the competent authority, or, where appropriate, by the control authority or the control body, after the start of the conversion plan. 9. The requirements concerning different species and varieties, laid down in points (a) and (b) of paragraph 7, shall not apply in the case of research and educational centres, plant nurseries, seed multipliers and breeding operations. 10. Where, in the cases referred to in paragraphs 7, 8 and 9, not all production units of a holding are managed under organic production rules, the operators shall: (a) keep the products used for the organic and in-conversion production units separate from those used for the non-organic production units; (b) keep the products produced by the organic, in-conversion and non-organic production units separate from each other; (c) keep adequate records to show the effective separation of the production units and of the products. 11. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending paragraph 7 of this Article by adding further rules on the splitting of a holding into organic, in-conversion and non-organic production units, in particular in relation to products listed in Annex I, or by amending those added rules. Article 10 Conversion 1. Farmers and operators that produce algae or aquaculture animals shall comply with a conversion period. During the whole conversion period they shall apply all rules on organic production laid down in this Regulation, in particular the applicable rules on conversion set out in this Article and in Annex II. 2. The conversion period shall start at the earliest when the farmer or the operator that produces algae or aquaculture animals has notified the activity to the competent authorities, in accordance with Article 34(1), in the Member State in which the activity is carried out and in which that farmer or operator’s holding is subject to the control system. 3. No previous period may be retroactively recognised as being part of the conversion period, except where: (a) the operator’s land parcels were subject to measures which were defined in a programme implemented pursuant to Regulation (EU) No 1305/2013 for the purpose of ensuring that no products or substances other than those authorised for use in organic production have been used on those land parcels; or (b) the operator can provide proof that the land parcels were natural or agricultural areas that, for a period of at least three years, have not been treated with products or substances that are not authorised for use in organic production. 4. Products produced during the conversion period shall not be marketed as organic products or as in-conversion products. However, the following products produced during the conversion period and in compliance with paragraph 1 may be marketed as in-conversion products: (a) plant reproductive material, provided that a conversion period of at least 12 months has been complied with; (b) food products of plant origin and feed products of plant origin, provided that the product contains only one agricultural crop ingredient, and provided that a conversion period of at least 12 months before the harvest has been complied with. 5. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending point 1.2.2 of Part II of Annex II by adding conversion rules for species other than those regulated in Part II of Annex II on 17 June 2018, or by amending those added rules. 6. The Commission shall, where appropriate, adopt implementing acts specifying the documents to be supplied for the purpose of the retroactive recognition of a previous period in accordance with paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 11 Prohibition of the use of GMOs 1. GMOs, products produced from GMOs, and products produced by GMOs shall not be used in food or feed, or as food, feed, processing aids, plant protection products, fertilisers, soil conditioners, plant reproductive material, micro-organisms or animals in organic production. 2. For the purposes of the prohibition laid down in paragraph 1, with regard to GMOs and products produced from GMOs for food and feed, operators may rely on the labels of a product that have been affixed or provided pursuant to Directive 2001/18/EC, Regulation (EC) No 1829/2003 of the European Parliament and of the Council (49) or Regulation (EC) No 1830/2003 of the European Parliament and of the Council (50) or any accompanying document provided pursuant thereto. 3. Operators may assume that no GMOs and no products produced from GMOs have been used in the manufacture of purchased food and feed where such products do not have a label affixed or provided, or are not accompanied by a document provided, pursuant to the legal acts referred to in paragraph 2, unless they have obtained other information indicating that the labelling of the products concerned is not in conformity with those legal acts. 4. For the purposes of the prohibition laid down in paragraph 1, with regard to products not covered by paragraphs 2 and 3, operators using non-organic products purchased from third parties shall require the vendor to confirm that those products are not produced from GMOs or produced by GMOs. Article 12 Plant production rules 1. Operators that produce plants or plant products shall comply, in particular, with the detailed rules set out in Part I of Annex II. 2. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending: (a) points 1.3 and 1.4 of Part I of Annex II as regards derogations; (b) point 1.8.5 of Part I of Annex II as regards the use of in-conversion and non-organic plant reproductive material; (c) point 1.9.5 of Part I of Annex II by adding further provisions concerning agreements between operators of agricultural holdings, or by amending those added provisions; (d) point 1.10.1 of Part I of Annex II by adding further pest- and weed-management measures, or by amending those added measures; (e) Part I of Annex II by adding further detailed rules and cultivation practices for specific plants and plant products, including rules for sprouted seeds, or by amending those added rules. Article 13 Specific provisions for the marketing of plant reproductive material of organic heterogeneous material 1. Plant reproductive material of organic heterogeneous material may be marketed without complying with the requirements for registration and without complying with the certification categories of pre-basic, basic and certified material or with the requirements for other categories, which are set out in Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 98/56/EC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC or acts adopted pursuant to those Directives. 2. Plant reproductive material of organic heterogeneous material as referred to in paragraph 1 may be marketed following a notification of the organic heterogeneous material by the supplier to the responsible official bodies referred to in Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 98/56/EC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC, made by means of a dossier containing: (a) the contact details of the applicant; (b) the species and denomination of the organic heterogeneous material; (c) the description of the main agronomic and phenotypic characteristics that are common to that plant grouping, including breeding methods, any available results from tests on those characteristics, the country of production and the parental material used; (d) a declaration by the applicant concerning the truth of the elements in points (a), (b) and (c); and (e) a representative sample. That notification shall be sent by registered letter, or by any other means of communication accepted by the official bodies, with confirmation of receipt requested. Three months after the date shown on the return receipt, provided that no additional information was requested or that no formal refusal for reasons of incompleteness of the dossier or non-compliance as defined in Article 3(57) was communicated to the supplier, the responsible official body shall be deemed to have acknowledged the notification and its content. After having expressly or implicitly acknowledged the notification, the responsible official body may proceed to the listing of the notified organic heterogeneous material. That listing shall be free of charge to the supplier. The listing of any organic heterogeneous material shall be communicated to the competent authorities of the other Member States and to the Commission. Such organic heterogeneous material shall fulfil the requirements laid down in the delegated acts adopted in accordance with paragraph 3. 3. The Commission is empowered to adopt delegated acts in accordance with Article 54 supplementing this Regulation by setting out rules governing the production and marketing of plant reproductive material of organic heterogeneous material of particular genera or species, as regards: (a) the description of the organic heterogeneous material, including the relevant breeding and production methods and parental material used; (b) the minimum quality requirements for seeds lots, including identity, specific purity, germination rates and sanitary quality; (c) labelling and packaging; (d) information and samples of production to be kept by the professional operators; (e) where applicable, maintenance of the organic heterogeneous material. Article 14 Livestock production rules 1. Livestock operators shall comply, in particular, with the detailed production rules set out in Part II of Annex II and in any implementing acts referred to in paragraph 3 of this Article. 2. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending: (a) points 1.3.4.2, 1.3.4.4.2 and 1.3.4.4.3 of Part II of Annex II by reducing the percentages as regards the origin of animals, once sufficient availability on the Union market of organic animals has been established; (b) point 1.6.6 of Part II of Annex II as regards the limit on organic nitrogen linked to the total stocking density; (c) point 1.9.6.2(b) of Part II of Annex II as regards the feeding of bee colonies; (d) points 1.9.6.3(b) and (e) of Part II of Annex II as regards the acceptable treatments for the disinfection of apiaries and the methods and treatments to fight against Varroa destructor; (e) Part II of Annex II by adding detailed rules on livestock production for species other than species regulated in that Part on 17 June 2018, or by amending those added rules, as regards: (i) derogations as regards the origin of animals; (ii) nutrition; (iii) housing and husbandry practices; (iv) health care; (v) animal welfare. 3. The Commission shall, where appropriate, adopt implementing acts regarding Part II of Annex II providing rules on: (a) the minimum period to be complied with for feeding of suckling animals with maternal milk, referred to in point 1.4.1(g); (b) the stocking density and the minimum surface for indoor and outdoor areas that are to be complied with for specific livestock species to ensure that the developmental, physiological and ethological needs of animals are met in accordance with points 1.6.3, 1.6.4 and 1.7.2, (c) the characteristics of and technical requirements for the minimum surface for indoor and outdoor areas; (d) the characteristics of and technical requirements for buildings and pens for all livestock species other than bees, to ensure that the developmental, physiological and ethological needs of animals are met in accordance with point 1.7.2; (e) requirements for vegetation and the characteristics of protected facilities and open air areas. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 15 Production rules for algae and aquaculture animals 1. Operators that produce algae and aquaculture animals shall comply, in particular, with the detailed production rules set out in Part III of Annex II and in any implementing acts referred to in paragraph 3 of this Article. 2. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending: (a) point 3.1.3.3 of Part III of Annex II as regards feed for carnivorous aquaculture animals; (b) point 3.1.3.4 of Part III of Annex II by adding further specific rules on feed for certain aquaculture animals, or by amending those added rules; (c) point 3.1.4.2 of Part III of Annex II as regards veterinary treatments for aquaculture animals; (d) Part III of Annex II by adding further detailed conditions per species for broodstock management, breeding and juvenile production, or by amending those added detailed conditions. 3. The Commission shall, where appropriate, adopt implementing acts laying down detailed rules per species or per group of species on the stocking density, and on the specific characteristics for production systems and containment systems, in order to ensure that the species-specific needs are met. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). 4. For the purpose of this Article and of Part III of Annex II, ‘stocking density’ means the live weight of aquaculture animals per cubic metre of water at any time during the grow-out phase and, in the case of flatfish and shrimp, the weight per square metre of surface. Article 16 Production rules for processed food 1. Operators that produce processed food shall comply, in particular, with the detailed production rules set out in Part IV of Annex II and in any implementing acts referred to in paragraph 3 of this Article. 2. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending: (a) point 1.4 of Part IV of Annex II as regards precautionary measures and preventive measures to be taken by operators; (b) point 2.2.2 of Part IV of Annex II as regards the types and composition of products and substances that are allowed for use in processed food, as well as conditions under which they may be used; (c) point 2.2.4 of Part IV of Annex II as regards the calculation of the percentage of agricultural ingredients referred to in points (a)(ii) and (b)(i) of Article 30(5), including the food additives authorised pursuant to Article 24 for use in organic production that are considered as agricultural ingredients for the purpose of such calculations. Those delegated acts shall not include the possibility of using flavouring substances or flavouring preparations which are neither natural, within the meaning of Article 16(2), (3) and (4) of Regulation (EC) No 1334/2008 of the European Parliament and of the Council (51), nor organic. 3. The Commission may adopt implementing acts laying down the techniques authorised in the processing of food products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 17 Production rules for processed feed 1. Operators that produce processed feed shall comply, in particular, with the detailed production rules set out in Part V of Annex II and in any implementing acts referred to in paragraph 3 of this Article. 2. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending point 1.4 of Part V of Annex II by adding further precautionary and preventive measures to be taken by operators, or by amending those added measures. 3. The Commission may adopt implementing acts laying down the techniques authorised for use in the processing of feed products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 18 Production rules for wine 1. Operators that produce products of the wine sector shall comply, in particular, with the detailed production rules set out in Part VI of Annex II. 2. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending: (a) point 3.2 of Part VI of Annex II by adding further oenological practices, processes and treatments that are prohibited, or by amending those added elements; (b) point 3.3. of Part VI of Annex II. Article 19 Production rules for yeast used as food or feed 1. Operators that produce yeast to be used as food or feed shall comply, in particular, with the detailed production rules set out in Part VII of Annex II. 2. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending point 1.3 of Part VII of Annex II by adding further detailed yeast production rules, or by amending those added rules. Article 20 Absence of certain production rules for specific livestock species and species of aquaculture animals Pending the adoption of: (a) additional general rules for other livestock species than those regulated in point 1.9 of Part II of Annex II in accordance with point (e) of Article 14(2); (b) the implementing acts referred to in Article 14(3) for livestock species; or (c) the implementing acts referred to in Article 15(3) for species or group of species of aquaculture animals; a Member State may apply detailed national production rules for specific species or groups of species of animals in relation to the elements to be covered by the measures referred to in points (a), (b) and (c), provided that those national rules are in accordance with this Regulation, and provided that they do not prohibit, restrict or impede the placing on the market of products which have been produced outside its territory and which comply with this Regulation. Article 21 Production rules for products not falling within the categories of products referred to in Articles 12 to 19 1. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending Annex II by adding detailed production rules, as well as rules on the obligation to convert, for products that do not fall within the categories of products referred to in Articles 12 to 19, or by amending those added rules. Those delegated acts shall be based on the objectives and principles of organic production laid down in Chapter II and shall comply with the general production rules laid down in Articles 9, 10 and 11 as well as existing detailed production rules laid down for similar products in Annex II. They shall lay down requirements concerning, in particular, the treatments, practices and inputs that are allowed or prohibited, or conversion periods for the products concerned. 2. In the absence of the detailed production rules referred to in paragraph 1: (a) operators shall, as regards products referred to in paragraph 1, comply with the principles laid down in Articles 5 and 6, mutatis mutandis with the principles laid down in Article 7, and with the general production rules laid down in Articles 9 to 11; (b) a Member State may, as regards products referred to in paragraph 1, apply detailed national production rules, provided that those rules are in accordance with this Regulation, and provided that they do not prohibit, restrict or impede the placing on the market of products which have been produced outside its territory and which comply with this Regulation. Article 22 Adoption of exceptional production rules 1. The Commission is empowered to adopt delegated acts in accordance with Article 54 supplementing this Regulation by laying down: (a) the criteria to determine whether a situation qualifies as catastrophic circumstances deriving from an ‘adverse climatic event’, ‘animal diseases’, an ‘environmental incident’, a ‘natural disaster’ or a ‘catastrophic event’, as defined in points (h), (i), (j), (k) and (l) of Article 2(1) of Regulation (EU) No 1305/2013, respectively, as well as any comparable situation; (b) specific rules, including possible derogations from this Regulation, on how Member States are to deal with such catastrophic circumstances if they decide to apply this Article; and (c) specific rules on monitoring and reporting in such cases. Those criteria and rules shall be subject to the principles of organic production laid down in Chapter II. 2. Where a Member State has formally recognised an event as a natural disaster as referred to in Article 18(3) or Article 24(3) of Regulation (EU) No 1305/2013, and that event makes it impossible to comply with the production rules laid down in this Regulation, that Member State may grant derogations from the production rules for a limited period until organic production can be re-established, subject to the principles laid down in Chapter II and to any delegated act adopted in accordance with paragraph 1. 3. Member States may adopt measures in accordance with the delegated act referred to in paragraph 1 to allow organic production to continue or recommence in the event of catastrophic circumstances. Article 23 Collection, packaging, transport and storage 1. Operators shall ensure that organic products and in-conversion products are collected, packaged, transported and stored in accordance with the rules set out in Annex III. 2. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending: (a) Section 2 of Annex III; (b) Sections 3, 4 and 6 of Annex III by adding further special rules for the transport and reception of the products concerned, or by amending those added rules. Article 24 Authorisation of products and substances for use in organic production 1. The Commission may authorise certain products and substances for use in organic production, and shall include any such authorised products and substances in restrictive lists, for the following purposes: (a) as active substances to be used in plant protection products; (b) as fertilisers, soil conditioners and nutrients; (c) as non-organic feed material of plant, algal, animal or yeast origin or as feed material of microbial or mineral origin; (d) as feed additives and processing aids; (e) as products for the cleaning and disinfection of ponds, cages, tanks, raceways, buildings or installations used for animal production; (f) as products for the cleaning and disinfection of buildings and installations used for plant production, including for storage on an agricultural holding; (g) as products for cleaning and disinfection in processing and storage facilities. 2. In addition to products and substances authorised in accordance with paragraph 1, the Commission may authorise certain products and substances for use in the production of processed organic food and of yeast used as food or feed, and shall include any such authorised products and substances in restrictive lists, for the following purposes: (a) as food additives and processing aids; (b) as non-organic agricultural ingredients to be used for the production of processed organic food; (c) as processing aids for the production of yeast and yeast products. 3. The authorisation of the products and substances referred to in paragraph 1 for use in organic production shall be subject to the principles laid down in Chapter II and to the following criteria, which shall be evaluated as a whole: (a) they are essential for sustained production and for the use for which they are intended; (b) all of the products and substances concerned are of plant, algal, animal, microbial or mineral origin, except in cases where products or substances from such sources are not available in sufficient quantities or qualities or where alternatives are not available; (c) in the case of products referred to in point (a) of paragraph 1: (i) their use is essential for the control of a pest for which other biological, physical or breeding alternatives, cultivation practices or other effective management practices are not available; (ii) if such products are not of plant, algal, animal, microbial or mineral origin and are not identical to their natural form, their conditions for use preclude any direct contact with the edible parts of the crop; (d) in the case of products referred to in point (b) of paragraph 1, their use is essential for building or maintaining the fertility of the soil or to fulfil specific nutritional requirements of crops, or for specific soil-conditioning purposes; (e) in the case of products referred to in points (c) and (d) of paragraph 1: (i) their use is necessary to maintain animal health, animal welfare and vitality and contributes to an appropriate diet fulfilling the physiological and behavioural needs of the species concerned or their use is necessary to produce or preserve feed because the production or preservation of feed is not possible without having recourse to such substances; (ii) feed of mineral origin, trace elements, vitamins or provitamins are of natural origin, except in cases where products or substances from such sources are not available in sufficient quantities or qualities or where alternatives are not available; (iii) the use of non-organic feed material of plant or animal origin is necessary because feed material of plant or animal origin produced in accordance with organic production rules is not available in sufficient quantity; (iv) the use of non-organic spices, herbs and molasses is necessary because such products are not available in organic form; they have to be produced or prepared without chemical solvents and their use is limited to 1 % of the feed ration for a given species, calculated annually as a percentage of the dry matter of feed from agricultural origin. 4. The authorisation of the products and substances referred to in paragraph 2 for use in the production of processed organic food or for the production of yeast used as food or feed shall be subject to the principles laid down in Chapter II and to the following criteria, which shall be evaluated as a whole: (a) alternative products or substances authorised in accordance with this Article or techniques compliant with this Regulation are not available; (b) it would be impossible to produce or preserve the food or to fulfil given dietary requirements provided for on the basis of Union legislation without having recourse to those products and substances; (c) they are to be found in nature and may only have undergone mechanical, physical, biological, enzymatic or microbial processes, except in cases where products or substances from such sources are not available in sufficient quantities or qualities; (d) the organic ingredient is not available in sufficient quantity. 5. The authorisation of the use of chemically synthesised products and substances, in accordance with paragraphs 1 and 2 of this Article, shall be strictly limited to cases where the use of external inputs referred to in point (g) of Article 5 would contribute to unacceptable impacts on the environment. 6. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending paragraphs 3 and 4 of this Article by adding further criteria for the authorisation of products and substances referred to in paragraphs 1 and 2 of this Article for use in organic production in general, and in the production of processed organic food in particular, as well as further criteria for the withdrawal of such authorisations, or by amending those added criteria. 7. Where a Member State considers that a product or substance should be added to or withdrawn from the lists of authorised products and substances referred to in paragraphs 1 and 2, or that the specifications of use referred to in the production rules should be amended, it shall ensure that a dossier giving the reasons for the inclusion, withdrawal or other amendments is officially sent to the Commission and to the other Member States and is made publicly available, subject to Union and national legislation on data protection. The Commission shall publish any requests referred to in this paragraph. 8. The Commission shall regularly review the lists referred to in this Article. The list of non-organic ingredients referred to in point (b) of paragraph 2 shall be reviewed at least once a year. 9. The Commission shall adopt implementing acts concerning the authorisation or withdrawal of authorisation of products and substances in accordance with paragraphs 1 and 2 that may be used in organic production in general and in the production of processed organic food in particular, and establishing the procedures to be followed for such authorisations and the lists of such products and substances and, where appropriate, their description, compositional requirements and conditions for use. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 25 Authorisation of non-organic agricultural ingredients for processed organic food by Member States 1. Where it is necessary in order to ensure access to certain agricultural ingredients, and where such ingredients are not available in organic form in sufficient quantity, a Member State may, at the request of an operator, provisionally authorise the use of non-organic agricultural ingredients for the production of processed organic food on its territory for a period of maximum six months. That authorisation shall apply to all operators in that Member State. 2. The Member State shall immediately notify the Commission and the other Member States, via a computer system that enables the electronic exchange of documents and information made available by the Commission, of any authorisation granted for its territory in accordance with paragraph 1. 3. The Member State may prolong the authorisation provided for in paragraph 1 two times for a maximum of six months each, provided that no other Member State has objected by indicating, via the system referred to in paragraph 2, that such ingredients are available in organic form in sufficient quantity. 4. A control authority or a control body recognised in accordance with Article 46(1) may grant a provisional authorisation, as referred to in paragraph 1 of this Article, for a maximum of six months to operators in third countries that request such an authorisation and that are subject to controls by that control authority or control body, provided that the conditions of that paragraph are fulfilled in the third country concerned. The authorisation may be prolonged for a maximum of two times six months each. 5. Where, after two prolongations of a provisional authorisation, a Member State considers, on the basis of objective information, that the availability of such ingredients in organic form remains insufficient to meet the qualitative and quantitative needs of operators, it may make a request to the Commission in accordance with Article 24(7). Article 26 Collection of data concerning the availability on the market of organic and in-conversion plant reproductive material, organic animals and organic aquaculture juveniles 1. Each Member State shall ensure that a regularly updated database is established for the listing of the organic and in-conversion plant reproductive material, excluding seedlings but including seed potatoes, which is available on its territory. 2. Member States shall have in place systems that allow operators that market organic or in-conversion plant reproductive material, organic animals or organic aquaculture juveniles, and that are able to supply them in sufficient quantities and within a reasonable period, to make public on a voluntary basis, free of charge, together with their names and contact details, information on the following: (a) the organic and in-conversion plant reproductive material, such as plant reproductive material of organic heterogeneous material or of organic varieties suitable for organic production, excluding seedlings but including seed potatoes, which is available; the quantity in weight of that material; and the period of the year of its availability; such material shall be listed using at least the Latin scientific name; (b) the organic animals for which derogation may be provided in accordance with point 1.3.4.4 of Part II of Annex II; the number of available animals categorised by sex; information, if relevant, relating to the different species of animals as regards the breeds and strains available; the races of the animals; the age of the animals; and any other relevant information; (c) the organic aquaculture juveniles available on the holding and their health status in accordance with Council Directive 2006/88/EC (52) and the production capacity for each aquaculture species. 3. Member States may also set up systems which allow operators that market breeds and strains adapted to organic production in accordance with point 1.3.3 of Part II of Annex II or organic pullets and that are able to supply those animals in sufficient quantities and within a reasonable period to make public the relevant information on a voluntary basis, free of charge, together with names and contact details. 4. Operators that opt to include information on plant reproductive material, animals or aquaculture juveniles in the systems referred to in paragraphs 2 and 3 shall ensure that the information is updated regularly, and shall ensure that the information is withdrawn from the lists once the plant reproductive material, animals or aquaculture juveniles are no longer available. 5. For the purpose of paragraphs 1, 2 and 3, Member States may continue to use relevant information systems that are already in existence. 6. The Commission shall make public the link to each of the national databases or systems on a dedicated website of the Commission, in order to allow users to have access to such databases or systems throughout the Union. 7. The Commission may adopt implementing acts providing: (a) technical details for establishing and maintaining the databases referred to in paragraph 1 and the systems referred to in paragraph 2; (b) specifications as regards the collection of information referred to in paragraph 1 and 2; (c) specifications as regards the arrangements for participation in the databases referred to in paragraph 1 and in the systems referred to in paragraphs 2 and 3; and (d) details as regards the information to be provided by Member States in accordance with Article 53(6). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 27 Obligations and actions in the event of suspicion of non-compliance Where an operator suspects that a product it has produced, prepared, imported or has received from another operator does not comply with this Regulation, that operator shall, subject to Article 28(2): (a) identify and separate the product concerned; (b) check whether the suspicion can be substantiated; (c) not place the product concerned on the market as an organic or in-conversion product and not use it in organic production, unless the suspicion can be eliminated; (d) where the suspicion has been substantiated or where it cannot be eliminated, immediately inform the relevant competent authority, or, where appropriate, the relevant control authority or control body, and provide it with available elements, where appropriate; (e) fully cooperate with the relevant competent authority, or, where appropriate, with the relevant control authority or control body, in verifying and identifying the reasons for the suspected non-compliance. Article 28 Precautionary measures to avoid the presence of non-authorised products and substances 1. In order to avoid contamination with products or substances that are not authorised in accordance with the first subparagraph of Article 9(3) for use in organic production, operators shall take the following precautionary measures at every stage of production, preparation and distribution: (a) put in place and maintain measures that are proportionate and appropriate to identify the risks of contamination of organic production and products with non-authorised products or substances, including systematic identification of critical procedural steps; (b) put in place and maintain measures that are proportionate and appropriate to avoid risks of contamination of organic production and products with non-authorised products or substances; (c) regularly review and adjust such measures; and (d) comply with other relevant requirements of this Regulation that ensure the separation of organic, in-conversion and non-organic products. 2. Where an operator suspects, due to the presence of a product or substance that is not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production in a product that is intended to be used or marketed as an organic or in-conversion product, that the latter product does not comply with this Regulation, the operator shall: (a) identify and separate the product concerned; (b) check whether the suspicion can be substantiated; (c) not place the product concerned on the market as an organic or in-conversion product and not use it in organic production unless the suspicion can be eliminated; (d) where the suspicion has been substantiated or where it cannot be eliminated, immediately inform the relevant competent authority, or, where appropriate, the relevant control authority or control body, and provide it with available elements, where appropriate; (e) fully cooperate with the relevant competent authority, or, where appropriate, with the relevant control authority or control body, in identifying and verifying the reasons for the presence of non-authorised products or substances. 3. The Commission may adopt implementing acts laying down uniform rules to specify: (a) the procedural steps to be followed by operators in accordance with points (a) to (e) of paragraph 2 and the relevant documents to be provided by them; (b) the proportionate and appropriate measures to be adopted and reviewed by operators to identify and avoid risks of contamination in accordance with points (a), (b) and (c) of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 29 Measures to be taken in the event of the presence of non-authorised products or substances 1. Where the competent authority, or, where appropriate, the control authority or control body, receives substantiated information about the presence of products or substances that are not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production, or has been informed by an operator in accordance with point (d) of Article 28(2), or detects such products or substances in an organic or an in-conversion product: (a) it shall immediately carry out an official investigation in accordance with Regulation (EU) 2017/625 with a view to determining the source and the cause in order to verify compliance with the first subparagraph of Article 9(3) and with Article 28(1); such investigation shall be completed as soon as possible, within a reasonable period, and shall take into account the durability of the product and the complexity of the case; (b) it shall provisionally prohibit both the placing on the market of the products concerned as organic or in-conversion products and their use in organic production pending the results of the investigation referred to in point (a). 2. The product concerned shall not be marketed as an organic or in-conversion product or used in organic production where the competent authority, or, where appropriate, the control authority or control body, has established that the operator concerned: (a) has used products or substances not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production; (b) has not taken the precautionary measures referred to in Article 28(1); or (c) has not taken measures in response to relevant previous requests from the competent authorities, control authorities or control bodies. 3. The operator concerned shall be given an opportunity to comment on the results of the investigation referred to in point (a) of paragraph 1. The competent authority, or, where appropriate, the control authority or control body, shall keep records of the investigation it has carried out. Where required, the operator concerned shall take such corrective measures as necessary to avoid future contamination. 4. By 31 December 2024, the Commission shall present a report to the European Parliament and the Council on the implementation of this Article, on the presence of products and substances not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production and on the assessment of the national rules referred to in paragraph 5 of this Article. That report may be accompanied, where appropriate, by a legislative proposal for further harmonisation. 5. Member States having in place rules providing for products that contain more than a certain level of products or substances not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production not to be marketed as organic products may continue to apply those rules, provided that those rules do not prohibit, restrict or impede the placing on the market of products produced in other Member States as organic products, where those products were produced in compliance with this Regulation. Member States that make use of this paragraph shall inform the Commission without delay. 6. The competent authorities shall document the results of the investigations referred to in paragraph 1, as well as any measures they have taken for the purpose of formulating best practices and further measures to avoid the presence of products and substances not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production. Member States shall make such information available to the other Member States and to the Commission via a computer system that enables the electronic exchange of documents and information made available by the Commission. 7. Member States may take appropriate measures on their territory to avoid the unintended presence in organic agriculture of products and substances not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production. Such measures shall not prohibit, restrict or impede the placing on the market of products produced in other Member States as organic or in-conversion products, where those products were produced in compliance with this Regulation. Member States that make use of this paragraph shall inform the Commission and the other Member States without delay. 8. The Commission shall adopt implementing acts laying down uniform rules to specify: (a) the methodology to be applied by competent authorities, or, where appropriate, by control authorities or control bodies, for the detection and evaluation of the presence of products and substances not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production; (b) the details and format of the information to be made available by Member States to the Commission and other Member States in accordance with paragraph 6 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). 9. By 31 March of each year, Member States shall electronically transmit to the Commission relevant information about cases involving contamination with non-authorised products or substances in the previous year, including information collected at border control posts, concerning the nature of contamination detected, and in particular the cause, the source and the level of contamination as well as the volume and nature of products contaminated. This information shall be collected by the Commission through the computer system made available by the Commission and shall be used to facilitate the formulation of best practices for avoiding contamination. CHAPTER IV LABELLING Article 30 Use of terms referring to organic production 1. For the purposes of this Regulation, a product shall be regarded as bearing terms referring to organic production where, in the labelling, advertising material or commercial documents, such a product, its ingredients or feed materials used for its production are described in terms suggesting to the purchaser that the product, ingredients or feed materials have been produced in accordance with this Regulation. In particular, the terms listed in Annex IV and their derivatives and diminutives, such as ‘bio’ and ‘eco’, whether alone or in combination, may be used throughout the Union and in any language listed in that Annex for the labelling and advertising of products referred to in Article 2(1) which comply with this Regulation. 2. For the products referred to in Article 2(1), the terms referred to in paragraph 1 of this Article shall not be used anywhere in the Union, in any language listed in Annex IV, for the labelling, advertising material or commercial documents of a product which does not comply with this Regulation. Furthermore, no terms, including terms used in trademarks or company names, or practices shall be used in labelling or advertising if they are liable to mislead the consumer or user by suggesting that a product or its ingredients comply with this Regulation. 3. Products that have been produced during the conversion period shall not be labelled or advertised as organic products or as in-conversion products. However, plant reproductive material, food products of plant origin and feed products of plant origin that have been produced during the conversion period, which comply with Article 10(4), may be labelled and advertised as in-conversion products by using the term ‘in-conversion’ or a corresponding term, together with the terms referred to in paragraph 1. 4. The terms referred to in paragraph 1 and 3 shall not be used for a product for which Union law requires the labelling or advertising to state that the product contains GMOs, consists of GMOs or is produced from GMOs. 5. For processed food, the terms referred to in paragraph 1 may be used: (a) in the sales description, and in the list of ingredients where such a list is mandatory pursuant to Union legislation, provided that: (i) the processed food complies with the production rules set out in Part IV of Annex II and with the rules laid down in accordance with Article 16(3); (ii) at least 95 % of the agricultural ingredients of the product by weight are organic; and (iii) in the case of flavourings, they are only used for natural flavouring substances and natural flavouring preparations labelled in accordance with Article 16(2), (3) and (4) of Regulation (EC) No 1334/2008 and all of the flavouring components and carriers of flavouring components in the flavouring concerned are organic; (b) only in the list of ingredients, provided that: (i) less than 95 % of the agricultural ingredients of the product by weight are organic, and provided that those ingredients comply with the production rules set out in this Regulation; and (ii) the processed food complies with the production rules set out in points 1.5, 2.1(a), 2.1(b) and 2.2.1 of Part IV of Annex II and with the rules laid down in accordance with Article 16(3); (c) in the sales description and in the list of ingredients, provided that: (i) the main ingredient is a product of hunting or fishing; (ii) the term referred to in paragraph 1 is clearly related in the sales description to another ingredient which is organic and different from the main ingredient; (iii) all other agricultural ingredients are organic; and (iv) the food complies with points 1.5, 2.1(a), 2.1(b) and 2.2.1 of Part IV of Annex II and with the rules laid down in accordance with Article 16(3). The list of ingredients referred to in points (a), (b) and (c) of the first subparagraph shall indicate which ingredients are organic. The references to organic production may only appear in relation to the organic ingredients. The list of ingredients referred to in points (b) and (c) of the first subparagraph shall include an indication of the total percentage of organic ingredients in proportion to the total quantity of agricultural ingredients. The terms referred to in paragraph 1, when used in the list of ingredients referred to in points (a), (b), and (c) of the first subparagraph of this paragraph, and the indication of the percentage referred to in the third subparagraph of this paragraph shall appear in the same colour, identical size and style of lettering as the other indications in the list of ingredients. 6. For processed feed, the terms referred to in paragraph 1 may be used in the sales description and in the list of ingredients, provided that: (a) the processed feed complies with the production rules set out in Parts II, III and V of Annex II and with the specific rules laid down in accordance with Article 16(3); (b) all of the ingredients of agricultural origin that are contained in the processed feed are organic; and (c) at least 95 % of the dry matter of the product are organic. 7. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending: (a) this Article by adding further rules on the labelling of products listed in Annex I, or by amending those added rules; and (b) the list of terms set out in Annex IV, taking into account linguistic developments within the Member States. 8. The Commission may adopt implementing acts to set detailed requirements for the application of paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 31 Labelling of products and substances used in crop production Notwithstanding the scope of this Regulation as set out in Article 2(1), products and substances used in plant protection products or as fertilisers, soil conditioners or nutrients that have been authorised in accordance with Articles 9 and 24 may bear a reference indicating that those products or substances have been authorised for use in organic production in accordance with this Regulation. Article 32 Compulsory indications 1. Where products bear terms as referred to in Article 30(1), including products labelled as in-conversion products in accordance with Article 30(3): (a) the code number of the control authority or control body to which the operator that carried out the last production or preparation operation is subject shall also appear in the labelling; and (b) in the case of prepacked food, the organic production logo of the European Union referred to in Article 33 shall also appear on the packaging, except in cases referred to in Article 30(3) and points (b) and (c) of Article 30(5). 2. Where the organic production logo of the European Union is used, an indication of the place where the agricultural raw materials of which the product is composed have been farmed shall appear in the same visual field as the logo and shall take one of the following forms, as appropriate: (a) ‘EU Agriculture’, where the agricultural raw material has been farmed in the Union; (b) ‘non-EU Agriculture’, where the agricultural raw material has been farmed in third countries; (c) ‘EU/non-EU Agriculture’, where a part of the agricultural raw materials has been farmed in the Union and a part of it has been farmed in a third country. For the purposes of the first subparagraph, the word ‘Agriculture’ may be replaced by ‘Aquaculture’ where appropriate and the words ‘EU’ and ‘non-EU’ may be replaced or supplemented by the name of a country, or by the name of a country and a region, if all of the agricultural raw materials of which the product is composed have been farmed in that country and, if applicable, in that region. For the indication of the place where the agricultural raw materials of which the product is composed have been farmed, as referred to in the first and third subparagraphs, small quantities by weight of ingredients may be disregarded, provided that the total quantity of the disregarded ingredients does not exceed 5 % of the total quantity by weight of agricultural raw materials. The words ‘EU’ or ‘non-EU’ shall not appear in a colour, size and style of lettering that is more prominent than the name of the product. 3. The indications referred to in paragraphs 1 and 2 of this Article and in Article 33(3) shall be marked in a conspicuous place in such a way as to be easily visible, and shall be clearly legible and indelible. 4. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending paragraph 2 of this Article and Article 33(3) by adding further rules on labelling, or by amending those added rules. 5. The Commission shall adopt implementing acts relating to: (a) practical arrangements for the use, presentation, composition and size of the indications referred to in point (a) of paragraph 1 and in paragraph 2 of this Article and in Article 33(3); (b) the assignment of code numbers to control authorities and control bodies; (c) the indication of the place where the agricultural raw materials were farmed, in accordance with paragraph 2 of this Article and with Article 33(3). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 33 Organic production logo of the European Union 1. The organic production logo of the European Union may be used in the labelling, presentation and advertising of products which comply with this Regulation. The organic production logo of the European Union may also be used for information and educational purposes related to the existence and advertising of the logo itself, provided that such use is not liable to mislead the consumer as regards the organic production of specific products, and provided that the logo is reproduced in accordance with the rules set out in Annex V. In such case, the requirements of Article 32(2) and point 1.7 of Annex V shall not apply. The organic production logo of the European Union shall not be used for processed food as referred to in points (b) and (c) of Article 30(5) and for in-conversion products as referred to in Article 30(3). 2. Except where used in accordance with the second subparagraph of paragraph 1, the organic production logo of the European Union is an official attestation in accordance with Articles 86 and 91 of Regulation (EU) 2017/625. 3. The use of the organic production logo of the European Union shall be optional for products imported from third countries. Where that logo appears in the labelling of such products, the indication referred to in Article 32(2) shall also appear in the labelling. 4. The organic production logo of the European Union shall follow the model set out in Annex V, and shall comply with the rules set out in that Annex. 5. National logos and private logos may be used in the labelling, presentation and advertising of products which comply with this Regulation. 6. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending Annex V as regards the organic production logo of the European Union and the rules relating thereto. CHAPTER V CERTIFICATION Article 34 Certification system 1. Prior to placing any products on the market as ‘organic’ or as ‘in-conversion’ or prior to the conversion period, operators and groups of operators referred to in Article 36 which produce, prepare, distribute or store organic or in-conversion products, which import such products from a third country or export such products to a third country, or which place such products on the market, shall notify their activity to the competent authorities of the Member State in which it is carried out and in which their undertaking is subject to the control system. Where the competent authorities have conferred their responsibilities or delegated certain official control tasks or certain tasks related to other official activities to more than one control authority or control body, the operators or groups of operators shall indicate in the notification referred to in the first subparagraph which control authority or control body verifies whether their activity complies with this Regulation and provides the certificate referred to in Article 35(1). 2. Operators that sell prepacked organic products directly to the final consumer or user shall be exempted from the notification obligation referred to in paragraph 1 of this Article and from the obligation to be in the possession of a certificate referred to in Article 35(2) provided that they do not produce, prepare, store other than in connection with the point of sale, or import such products from a third country, or subcontract such activities to another operator. 3. Where operators or groups of operators subcontract any of their activities to third parties, both the operators or groups of operators and the third parties to whom those activities have been subcontracted shall comply with paragraph 1, unless the operator or group of operators has declared in the notification referred to in paragraph 1 that it remains responsible as regards organic production and that it has not transferred that responsibility to the subcontractor. In such cases, the competent authority, or, where appropriate, the control authority or control body, shall verify that the subcontracted activities comply with this Regulation, in the context of the control it carries out on the operators or groups of operators that have subcontracted their activities. 4. Member States may designate an authority or approve a body which is to receive the notifications referred to in paragraph 1. 5. Operators, groups of operators and subcontractors shall keep records in accordance with this Regulation on the different activities they engage in. 6. Member States shall keep updated lists containing the names and addresses of operators and groups of operators that have notified their activities in accordance with paragraph 1 and shall make public in an appropriate manner, including by means of links to a single internet website, a comprehensive list of this data, together with the information relating to the certificates provided to those operators and groups of operators in accordance with Article 35(1). When doing so, Member States shall comply with the requirements for the protection of personal data under Regulation (EU) 2016/679 of the European Parliament and of the Council (53). 7. Member States shall ensure that any operator or group of operators that complies with this Regulation and, in cases where a fee is collected in accordance with Articles 78 and 80 of Regulation (EU) 2017/625, that pays a reasonable fee covering the cost of controls is entitled to be covered by the control system. Member States shall ensure that any fees that may be collected are made public. 8. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending Annex II as regards the requirements for keeping records. 9. The Commission may adopt implementing acts to provide details and specifications regarding: (a) the format and technical means of the notification referred to in paragraph 1; (b) the arrangements for the publication of the lists referred to in paragraph 6; and (c) the procedures and the arrangements for publication of the fees referred to in paragraph 7. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 35 Certificate 1. Competent authorities, or, where appropriate, control authorities or control bodies, shall provide a certificate to any operator or group of operators that has notified its activity in accordance with Article 34(1) and complies with this Regulation. The certificate shall: (a) be issued in electronic form wherever possible; (b) allow at least the identification of the operator or group of operators including the list of the members, the category of products covered by the certificate and its period of validity; (c) certify that the notified activity complies with this Regulation; and (d) be issued in accordance with the model set out in Annex VI. 2. Without prejudice to paragraph 8 of this Article and to Article 34(2), operators and groups of operators shall not place products referred to in Article 2(1) on the market as organic products or in-conversion products unless they are already in possession of a certificate as referred to in paragraph 1 of this Article. 3. The certificate referred to in this Article shall be an official certificate within the meaning of point (a) of Article 86(1) of Regulation (EU) 2017/625. 4. An operator or a group of operators shall not be entitled to obtain a certificate from more than one control body in relation to activities carried out in the same Member State regarding the same category of products, including cases in which that operator or group of operators operates at different stages of production, preparation and distribution. 5. Members of a group of operators shall not be entitled to obtain an individual certificate for any of the activities covered by the certification of the group of operators to which they belong. 6. Operators shall verify the certificates of those operators that are their suppliers. 7. For the purposes of paragraphs 1 and 4 of this Article, products shall be classified in accordance with the following categories: (a) unprocessed plants and plant products, including seeds and other plant reproductive material; (b) livestock and unprocessed livestock products; (c) algae and unprocessed aquaculture products; (d) processed agricultural products, including aquaculture products, for use as food; (e) feed; (f) wine; (g) other products listed in Annex I to this Regulation or not covered by the previous categories. 8. Member States may exempt from the obligation to be in the possession of a certificate, provided for in paragraph 2, operators that sell unpacked organic products other than feed directly to the final consumer, provided that those operators do not produce, prepare, store other than in connection with the point of sale, or import such products from a third country, or subcontract such activities to a third party, and provided that: (a) such sales do not exceed 5 000 kg per year; (b) such sales do not represent an annual turnover in relation to unpacked organic products exceeding EUR 20 000; or (c) the potential certification cost of the operator exceeds 2 % of the total turnover on unpacked organic products sold by that operator. If a Member State decides to exempt the operators referred to in the first subparagraph, it may set stricter limits than those set in the first subparagraph. Member States shall inform the Commission and the other Member States of any decision to exempt operators pursuant to the first subparagraph and of the limits up to which such operators are exempted. 9. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending the model of the certificate set out in Annex VI. 10. The Commission shall adopt implementing acts to provide details and specifications regarding the form of the certificate referred to in paragraph 1 and the technical means by which it is issued. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 36 Group of operators 1. Each group of operators shall: (a) only be composed of members who are farmers or operators that produce algae or aquaculture animals and who in addition may be engaged in processing, preparation or placing on the market of food or feed; (b) only be composed of members: (i) of which the individual certification cost represents more than 2 % of each member’s turnover or standard output of organic production and whose annual turnover of organic production is not more than EUR 25 000 or whose standard output of organic production is not more than EUR 15 000 per year; or (ii) who have each holdings of maximum: — five hectares, — 0,5 hectares, in the case of greenhouses, or — 15 hectares, exclusively in the case of permanent grassland; (c) be established in a Member State or a third country; (d) have legal personality; (e) only be composed of members whose production activities take place in geographical proximity to each other; (f) set up a joint marketing system for the products produced by the group; and (g) establish a system for internal controls comprising a documented set of control activities and procedures in accordance with which an identified person or body is responsible for verifying compliance with this Regulation of each member of the group. 2. Competent authorities, or, where appropriate, control authorities or control bodies, shall withdraw the certificate referred to in Article 35 for the whole group where deficiencies in the set-up or functioning of the system for internal controls referred to in paragraph 1, in particular as regards failures to detect or address non-compliance by individual members of the group of operators, affect the integrity of organic and in-conversion products. 3. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending paragraphs 1 and 2 of this Article by adding provisions, or by amending those added provisions, in particular as regards: (a) the responsibilities of the individual members of a group of operators; (b) the criteria to determine the geographical proximity of the members of the group, such as the sharing of facilities or sites; (c) the set-up and functioning of the system for internal controls, including the scope, content and frequency of the controls to be carried out and the criteria to identify deficiencies in the set-up or functioning of the system for internal controls. 4. The Commission may adopt implementing acts laying down specific rules concerning: (a) the composition and dimension of a group of operators; (b) the documents and record-keeping systems, the system for internal traceability and the list of operators; (c) the exchange of information between a group of operators and the competent authority or authorities, control authorities or control bodies, and between the Member States and the Commission. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). CHAPTER VI OFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIES Article 37 Relationship with Regulation (EU) 2017/625 and additional rules for official controls and other official activities in relation to organic production and labelling of organic products The specific rules of this Chapter shall apply, in addition to the rules laid down in Regulation (EU) 2017/625, save as otherwise provided for in Article 40(2) of this Regulation, and in addition to Article 29 of this Regulation, save as otherwise provided for in Article 41(1) of this Regulation, to the official controls and other official activities performed to verify throughout the entire process at all stages of production, preparation and distribution that the products referred to in Article 2(1) of this Regulation have been produced in compliance with this Regulation. Article 38 Additional rules on official controls and on action to be taken by the competent authorities 1. Official controls performed in accordance with Article 9 of Regulation (EU) 2017/625 for the verification of compliance with this Regulation shall include, in particular: (a) the verification of the application by operators of preventive and precautionary measures, as referred to in Article 9(6) and in Article 28 of this Regulation, at every stage of production, preparation and distribution; (b) where the holding includes non-organic or in-conversion production units, the verification of the records and of the measures or procedures or arrangements in place to ensure the clear and effective separation between organic, in-conversion and non-organic production units as well as between the respective products produced by those units, and of the substances and products used for organic, in-conversion and non-organic production units; such verification shall include checks on parcels for which a previous period was recognised retroactively as part of the conversion period, and checks on the non-organic production units; (c) where organic, in-conversion and non-organic products are collected simultaneously by operators, are prepared or stored in the same preparation unit, area or premises, or are transported to other operators or units, the verification of the records and of the measures, procedures or arrangements in place to ensure that operations are carried out separated by place or time, that suitable cleaning measures and, where appropriate, measures to prevent substitution of products are implemented, that organic products and in-conversion products are identified at all times and that organic, in-conversion and non-organic products are stored, before and after the preparation operations, separated by place or time from each other; (d) the verification of the set-up and functioning of the internal control system of groups of operators; (e) where operators are exempted from the notification obligation in accordance with Article 34(2) of this Regulation or from the obligation to be in the possession of a certificate in accordance with Article 35(8) of this Regulation, the verification that the requirements for that exemption have been fulfilled and the verification of the products sold by those operators. 2. Official controls performed in accordance with Article 9 of Regulation (EU) 2017/625 for the verification of compliance with this Regulation shall be performed throughout the entire process at all stages of production, preparation and distribution on the basis of the likelihood of non-compliance as defined in point (57) of Article 3 of this Regulation, which shall be determined taking into account, in addition to the elements referred to in Article 9 of Regulation (EU) 2017/625, in particular the following elements: (a) the type, size and structure of the operators and groups of operators; (b) the length of time during which operators and groups of operators have been involved in organic production, preparation and distribution; (c) the results of the controls performed in accordance with this Article; (d) the point in time relevant for the activities carried out; (e) the product categories; (f) the type, quantity and value of products and their development over time; (g) the possibility of commingling of products or contamination with non-authorised products or substances; (h) the application of derogations or exceptions to the rules by operators and groups of operators; (i) the critical points for non-compliance and the likelihood of non-compliance at every stage of production, preparation and distribution; (j) subcontracting activities. 3. In any case, all operators and groups of operators, with the exception of those referred to in Articles 34(2) and 35(8), shall be subject to a verification of compliance at least once a year. The verification of compliance shall include a physical on-the-spot inspection, except where the following conditions have been satisfied: (a) the previous controls of the operator or group of operators concerned have not revealed any non-compliance affecting the integrity of organic or in-conversion products during at least three consecutive years; and (b) the operator or group of operators concerned has been assessed on the basis of the elements referred to in paragraph 2 of this Article and in Article 9 of Regulation (EU) 2017/625 as presenting a low likelihood of non-compliance. In this case, the period between two physical on-the-spot inspections shall not exceed 24 months. 4. Official controls performed in accordance with Article 9 of Regulation (EU) 2017/625 for the verification of compliance with this Regulation shall: (a) be performed in accordance with Article 9(4) of Regulation (EU) 2017/625 while ensuring that a minimum percentage of all official controls of operators or groups of operators are carried out without prior notice; (b) ensure that a minimum percentage of additional controls to those referred in paragraph 3 of this Article are carried out; (c) be carried out by taking a minimum number of the samples that have been taken in accordance with point (h) of Article 14 of Regulation (EU) 2017/625; (d) ensure that a minimum number of operators that are members of a group of operators are controlled in connection with the verification of compliance referred to in paragraph 3 of this Article. 5. The delivery or renewal of the certificate referred to in Article 35(1) shall be based on the results of the verification of compliance referred to in paragraphs 1 to 4 of this Article. 6. The written record to be drawn up regarding each official control that has been performed to verify compliance with this Regulation in accordance with Article 13(1) of Regulation (EU) 2017/625 shall be countersigned by the operator or groups of operators as confirmation of their receipt of that written record. 7. Article 13(1) of Regulation (EU) 2017/625 shall not apply to audits and inspections carried out by competent authorities in the context of their supervisory activities over control bodies to which certain official control tasks or certain tasks related to other official activities have been delegated. 8. The Commission is empowered to adopt delegated acts in accordance with Article 54: (a) supplementing this Regulation by laying down specific criteria and conditions for the performance of official controls conducted to ensure the traceability at all stages of production, preparation and distribution, and compliance with this Regulation, concerning: (i) checks of documentary accounts; (ii) controls performed on specific categories of operators; (iii) where appropriate, the period within which the controls provided for in this Regulation, including the physical on-the-spot inspections referred to in paragraph 3 of this Article, are to be performed and the particular premises in or area on which they are to be performed; (b) amending paragraph 2 of this Article by adding further elements based on practical experience, or by amending those added elements. 9. The Commission may adopt implementing acts to specify: (a) the minimum percentage of all official controls of operators or groups of operators that are to be carried out without prior notice as referred to in point (a) of paragraph 4; (b) the minimum percentage of additional controls referred to in point (b) of paragraph 4; (c) the minimum number of samples referred to in point (c) of paragraph 4; (d) the minimum number of operators that are members of a group of operators referred to in point (d) of paragraph 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 39 Additional rules on actions to be taken by the operators and groups of operators 1. In addition to the obligations laid down in Article 15 of Regulation (EU) 2017/625, operators and groups of operators shall: (a) keep records to demonstrate their compliance with this Regulation; (b) make all declarations and other communications that are necessary for official controls; (c) take relevant practical measures to ensure compliance with this Regulation; (d) provide, in form of a declaration to be signed and updated as necessary: (i) the full description of the organic or in-conversion production unit and of the activities to be performed in accordance with this Regulation; (ii) the relevant practical measures to be taken to ensure compliance with this Regulation; (iii) an undertaking: — to inform in writing and without undue delay buyers of the products and to exchange relevant information with the competent authority, or, where appropriate, with the control authority or control body, in the event that a suspicion of non-compliance has been substantiated, that a suspicion of non-compliance cannot be eliminated, or that non-compliance that affects the integrity of the products in question has been established, — to accept the transfer of the control file in the case of change of control authority or control body or, in the case of withdrawal from organic production, the keeping of the control file for at least five years by the last control authority or control body, — to immediately inform the competent authority or the authority or body designated in accordance with Article 34(4) in the event of withdrawal from organic production, and — to accept the exchange of information among those authorities or bodies in the event that subcontractors are subject to controls by different control authorities or control bodies. 2. The Commission may adopt implementing acts to provide details and specifications regarding: (a) the records for demonstrating compliance with this Regulation; (b) the declarations and other communications that are necessary for official controls; (c) the relevant practical measures for ensuring compliance with this Regulation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 40 Additional rules on the delegation of official control tasks and tasks related to other official activities 1. Competent authorities may delegate to control bodies certain official control tasks and certain tasks related to other official activities only if the following conditions, in addition to those set out in Chapter III of Regulation (EU) 2017/625, are satisfied: (a) the delegation contains a detailed description of the delegated official control tasks and tasks related to other official activities, including reporting obligations and other specific obligations, and of the conditions under which the control body may carry them out. In particular, the control body shall have submitted the following to the competent authorities for prior approval: (i) its risk assessment procedure, which is to determine, in particular, the basis for the intensity and frequency of the verification of compliance of the operators and groups of operators, which is to be established on the basis of the elements referred to in Article 9 of Regulation (EU) 2017/625 and of Article 38 of this Regulation, and which is to be followed for official controls on operators and groups of operators; (ii) the standard control procedure, which is to contain a detailed description of the control measures that the control body undertakes to apply to the operators and groups of operators that are subject to its controls; (iii) a list of measures that are in conformity with the common catalogue referred to in Article 41(4), and that are to be applied to operators and groups of operators in cases of suspected or established non-compliance; (iv) the arrangements for the effective monitoring of the official control tasks and tasks related to other official activities carried out in relation to operators and groups of operators and the arrangements for reporting on those tasks. The control body shall notify subsequent amendment of the elements referred to in points (i) to (iv) to the competent authority; (b) those competent authorities have procedures and arrangements in place to ensure the supervision of control bodies, including to verify that the delegated tasks are carried out effectively, independently and objectively, in particular as regards the intensity and frequency of the verification of compliance. At least once a year, competent authorities shall, pursuant to point (a) of Article 33 of Regulation (EU) 2017/625, organise audits of the control bodies to whom they have delegated official control tasks or tasks related to other official activities. 2. By way of derogation from Article 31(3) of Regulation (EU) 2017/625, competent authorities may delegate to a control body the decision concerning the tasks provided for in point (b) of Article 138(1) and in Article 138(2) and (3) of that Regulation. 3. For the purpose of point (b)(iv) of Article 29 of Regulation (EU) 2017/625, the standard for the delegation of certain official control tasks and certain tasks related to other official activities to verify compliance with this Regulation which is relevant in relation to the scope of this Regulation is the most recently notified version of the international harmonised standard for ‘Conformity assessment – Requirements for bodies certifying products, processes and services’, the reference of which has been published in the Official Journal of the European Union. 4. Competent authorities shall not delegate the following official control tasks and tasks related to other official activities to control bodies: (a) the supervision and audit of other control authorities or control bodies; (b) the power to grant derogations other than derogations for the use of plant reproductive material not obtained from organic production; (c) the authority to receive notifications of activities by operators or groups of operators under Article 34(1) of this Regulation; (d) the assessment of the likelihood of non-compliance with the provisions of this Regulation that determine the frequency with which physical checks are to be performed on organic consignments prior to their release for free circulation into the Union in accordance with Article 54 of Regulation (EU) 2017/625; (e) the establishment of the common catalogue of measures referred to in Article 41(4) of this Regulation. 5. Competent authorities shall not delegate official control tasks or tasks related to other official activities to natural persons. 6. Competent authorities shall ensure that information received from control bodies pursuant to Article 32 of Regulation (EU) 2017/625 and information on the measures applied by control bodies in the case of established or likely non-compliance is collected and used by the competent authorities in order to supervise the activities of those controls bodies. 7. Where a competent authority has fully or partially withdrawn the delegation of certain official control tasks or certain tasks related to other official activities in accordance with point (b) of Article 33 of Regulation (EU) 2017/625, it shall decide whether any certificates issued by the control bodies concerned before the date of that partial or full withdrawal are to remain valid, and shall inform the operators concerned of that decision. 8. Without prejudice to point (b) of Article 33 of Regulation (EU) 2017/625, before fully or partly withdrawing the delegation of official control tasks or tasks related to other official activities in the cases referred to in that point, competent authorities may fully or partly suspend that delegation: (a) for a period that shall not exceed 12 months, during which the control body is to remedy the shortcomings identified during audits and inspections or to address the non-compliance about which information was shared with other control authorities and control bodies, with competent authorities as well as with the Commission in accordance with Article 43 of this Regulation; or (b) for the period during which the accreditation referred to in point (b)(iv) of Article 29 of Regulation (EU) 2017/625, in connection with Article 40(3) of this Regulation, is suspended. Where the delegation of official control tasks or tasks related to other official activities has been suspended, the control bodies concerned shall not issue certificates referred to in Article 35 for those parts for which the delegation has been suspended. Competent authorities shall decide whether any certificates issued by the control bodies concerned before the date of that partial or full suspension are to remain valid, and shall inform the operators concerned of that decision. Without prejudice to Article 33 of Regulation (EU) 2017/625, the competent authorities shall lift the suspension of the delegation of official control tasks or tasks related to other official activities as soon as possible once the control body has remedied the shortcomings or non-compliances referred to in point (a) of the first subparagraph or once the accreditation body has lifted the suspension of the accreditation referred to in point (b) of the first subparagraph. 9. Where a control body to whom competent authorities have delegated certain official control tasks or certain tasks related to other official activities has also been recognised by the Commission in accordance with Article 46(1) of this Regulation to carry out control activities in third countries, and the Commission intends to withdraw or has withdrawn the recognition of that control body, competent authorities shall organise audits or inspections on the control body as regards its activities in the Member State(s) concerned in accordance with point (a) of Article 33 of Regulation (EU) 2017/625. 10. The control bodies shall transmit to the competent authorities: (a) a list of the operators which were subject to their controls on 31 December of the previous year by 31 January of each year; and (b) information on the official controls and other official activities carried out in the previous year to support the preparation of the part on organic production and labelling of organic products of the annual report referred to in Article 113 of Regulation (EU) 2017/625 by 31 March of each year. 11. The Commission is empowered to adopt delegated acts in accordance with Article 54 supplementing this Regulation as regards conditions for the delegation of official control tasks and tasks related to other official activities to control bodies additional to the conditions laid down in paragraph 1 of this Article. Article 41 Additional rules on actions in case of non-compliance 1. Subject to Article 29, where a competent authority, or, where appropriate, a control authority or control body, suspects or receives substantiated information, including information from other competent authorities, or, where appropriate, from other control authorities or control bodies, that an operator intends to use or to place on the market a product which may not be in compliance with this Regulation but which bears terms referring to the organic production, or where such competent authority, control authority or control body has been informed by an operator of a suspicion of non-compliance in accordance with Article 27: (a) it shall immediately carry out an official investigation in accordance with Regulation (EU) 2017/625 with a view to verifying compliance with this Regulation; such investigation shall be completed as soon as possible, within a reasonable period, and shall take into account the durability of the product and the complexity of the case; (b) it shall provisionally prohibit both the placing on the market of the products concerned as organic or in-conversion products and their use in organic production pending the results of the investigation referred to in point (a). Before taking such a decision, the competent authority, or, where appropriate, the control authority or control body, shall give the operator an opportunity to comment. 2. In the event that the results of the investigation referred to in point (a) of paragraph 1 do not show any non-compliance affecting the integrity of organic or in-conversion products, the operator shall be allowed to use the products concerned or to place them on the market as organic or in-conversion products. 3. Member States shall take any measures, and provide for any necessary sanctions, to prevent fraudulent use of the indications referred to in Chapter IV of this Regulation. 4. Competent authorities shall provide a common catalogue of measures for cases of suspected non-compliance and established non-compliance to be applied in their territory, including by control authorities and control bodies. 5. The Commission may adopt implementing acts to specify uniform arrangements for the cases where competent authorities are to take measures in relation to suspected or established non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 42 Additional rules on measures in the event of non-compliance 1. In the event of non-compliance affecting the integrity of organic or in-conversion products throughout any of the stages of production, preparation and distribution, for example as result of the use of non-authorised products, substances or techniques, or commingling with non-organic products, competent authorities, and, where appropriate, control authorities and control bodies, shall ensure, in addition to the measures to be taken in accordance with Article 138 of Regulation (EU) 2017/625, that no reference is made to organic production in the labelling and advertising of the entire lot or production run concerned. 2. In the event of serious, or repetitive or continued non-compliance, competent authorities, and, where appropriate, control authorities and control bodies, shall ensure that the operators or the groups of operators concerned, in addition to the measures laid down in paragraph 1 and any appropriate measures taken in particular in accordance with Article 138 of Regulation (EU) 2017/625, are prohibited from marketing products which refer to organic production for a given period, and that their certificate referred to in Article 35 be suspended or withdrawn, as appropriate. Article 43 Additional rules on the exchange of information 1. In addition to the obligations laid down in Article 105(1) and Article 106(1) of Regulation (EU) 2017/625, competent authorities shall immediately share information with other competent authorities, as well as with the Commission, on any suspicion of non–compliance that affects the integrity of organic or in-conversion products. Competent authorities shall share that information with other competent authorities and the Commission via a computer system that enables the electronic exchanges of documents and information made available by the Commission. 2. In cases where suspected or established non-compliance has been identified with regard to products under the control of other control authorities or control bodies, control authorities and control bodies shall immediately inform those other control authorities or control bodies. 3. Control authorities and control bodies shall exchange other relevant information with other control authorities and control bodies. 4. Upon receiving a request for information that is justified by the need to guarantee that a product has been produced in accordance with this Regulation, control authorities and control bodies shall exchange with other competent authorities, as well as with the Commission, information on the results of their controls. 5. Competent authorities shall exchange information on the supervision of the control bodies with national accreditation bodies as defined in point (11) of Article 2 of Regulation (EC) No 765/2008 of the European Parliament and of the Council (54). 6. Competent authorities shall take appropriate measures and establish documented procedures in order to ensure that information about the results of controls is communicated to the paying agency in accordance with its needs for the purpose of Article 58 of Regulation (EU) No 1306/2013 of the European Parliament and of the Council (55) and the acts adopted on the basis of that Article. 7. The Commission may adopt implementing acts to specify the information to be provided by the competent authorities, control authorities and control bodies in charge of the official controls and other official activities in accordance with this Article, the relevant recipients of that information and the procedures in accordance with which this information is to be provided, including the functionalities of the computer system referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). CHAPTER VII TRADE WITH THIRD COUNTRIES Article 44 Export of organic products 1. A product may be exported from the Union as an organic product and may bear the organic production logo of the European Union, provided that it complies with the rules for organic production under this Regulation. 2. The Commission is empowered to adopt delegated acts in accordance with Article 54 supplementing this Regulation as regards documents intended for customs authorities in third countries, in particular as regards the issuing of organic export certificates in electronic form wherever possible and the provision of assurances that exported organic products comply with this Regulation. Article 45 Import of organic and in-conversion products 1. A product may be imported from a third country for the purpose of placing that product on the market within the Union as an organic product or as an in-conversion product, provided that the following three conditions are met: (a) the product is a product as referred to in Article 2(1); (b) one of the following applies: (i) the product complies with Chapters II, III and IV of this Regulation, and all operators and groups of operators referred to in Article 36, including exporters in the third country concerned, have been subject to controls by control authorities or control bodies recognised in accordance with Article 46, and those authorities or bodies have provided all such operators, groups of operators and exporters with a certificate confirming that they comply with this Regulation; (ii) in cases where the product comes from a third country which is recognised in accordance with Article 47, that product complies with the conditions laid down in the relevant trade agreement; or (iii) in cases where the product comes from a third country which is recognised in accordance with Article 48, that product complies with the equivalent production and control rules of that third country and is imported with a certificate of inspection confirming this compliance that was issued by the competent authorities, control authorities or control bodies of that third country; and (c) the operators in third countries are able at any time to provide the importers and the national authorities in the Union and in those third countries with information allowing the identification of the operators that are their suppliers and the control authorities or control bodies of those suppliers, with a view to ensuring the traceability of the organic or in-conversion product concerned. That information shall also be made available to the control authorities or control bodies of the importers. 2. The Commission may, in accordance with the procedure set out in Article 24(9), grant specific authorisations for the use of products and substances in third countries and in the outermost regions of the Union, taking into account differences in the ecological balance in plant or animal production, specific climatic conditions, traditions and local conditions in those areas. Such specific authorisations may be granted for a renewable period of two years and shall be subject to the principles laid down in Chapter II and to the criteria set out in Article 24(3) and (6). 3. When providing for the criteria for determining whether a situation qualifies as catastrophic circumstances, and when laying down specific rules on how to deal with such circumstances in accordance with Article 22, the Commission shall take into account differences in the ecological balance, climate and local conditions in third countries and in the outermost regions of the Union. 4. The Commission shall adopt implementing acts to lay down specific rules concerning the content of the certificates referred to in point (b) of paragraph 1, the procedure to be followed for their issuance, their verification and the technical means by which the certificate is issued, in particular as regards the role of competent authorities, control authorities and control bodies, ensuring the traceability and compliance of imported products intended to be placed on the Union market as organic products or as in-conversion products as referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). 5. Compliance with the conditions and measures for the import of organic products and in-conversion products referred to in paragraph 1 into the Union shall be ascertained at border control posts, in accordance with Article 47(1) of Regulation (EU) 2017/625. The frequency of the physical checks referred to in Article 49(2) of that Regulation shall depend on the likelihood of non-compliance as defined in point (57) of Article 3 of this Regulation. Article 46 Recognition of control authorities and control bodies 1. The Commission may adopt implementing acts to recognise control authorities and control bodies that are competent to carry out controls and to issue organic certificates in third countries, to withdraw the recognition of such control authorities and control bodies, and to establish a list of recognised control authorities and control bodies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). 2. Control authorities or control bodies shall be recognised in accordance with paragraph 1 of this Article for the control of import of the categories of products listed in Article 35(7) if they fulfil the following criteria: (a) they are legally established in one Member State or third country; (b) they have the capacity to carry out controls to ensure that the conditions set out in points (a), (b)(i) and (c) of Article 45(1) and in this Article are met in relation to organic products and in-conversion products intended for import into the Union; (c) they offer adequate guarantees of objectivity and impartiality and are free from any conflict of interest as regards the exercise of their control tasks; (d) in the case of control bodies, they are accredited under the relevant harmonised standard for ‘Conformity assessment – Requirements for bodies certifying products, processes and services’, the reference of which has been published in the Official Journal of the European Union; (e) they have the expertise, equipment and infrastructure required to carry out control tasks, and have a sufficient number of suitable qualified and experienced staff; and (f) they meet any additional criteria that may be laid down in a delegated act adopted pursuant to paragraph 7. 3. The accreditation referred to in point (d) of paragraph 2 may only be granted by: (a) a national accreditation body in the Union in accordance with Regulation (EC) No 765/2008; or (b) an accreditation body outside the Union that is a signatory of a multilateral recognition arrangement under the auspices of the International Accreditation Forum. 4. Control authorities and control bodies shall submit a request for recognition to the Commission. Such request shall consist of a technical dossier containing all information that is necessary to ensure that the criteria set out in paragraph 2 are met. The control authorities shall provide the latest assessment report issued by the competent authority, and the control bodies shall provide the accreditation certificate issued by the accreditation body. Where appropriate, control authorities or control bodies shall also provide latest reports on the regular on-the-spot evaluation, surveillance and multiannual re-assessment of their activities. 5. Based on the information referred to under paragraph 4 and on any other relevant information relating to the control authority or control body, the Commission shall ensure appropriate supervision of the recognised control authorities and control bodies by regularly reviewing their performance and recognition. For the purposes of that supervision, the Commission may request additional information from the accreditation bodies or the competent authorities, as appropriate. 6. The nature of the supervision referred to in paragraph 5 shall be determined on the basis of an assessment of the likelihood of non-compliance, taking into account, in particular, the activity of the control authority or control body, the type of products and operators under its control and the changes in the production rules and control measures. The recognition of control authorities or of control bodies referred to in paragraph 1 shall in particular be withdrawn without delay, in accordance with the procedure referred to in that paragraph, where serious or repetitive infringements as regards the certification or the controls and actions laid down in accordance with paragraph 8 have been detected and where the control authority or control body concerned has failed to take appropriate and timely remedial action in reaction to a request by the Commission within a period determined by the Commission. Such period shall be determined in accordance with the severity of the problem and in general shall not be less than 30 days. 7. The Commission is empowered to adopt delegated acts in accordance with Article 54: (a) amending paragraph 2 of this Article by adding further criteria to those laid down therein for the recognition of the control authorities and control bodies referred to in paragraph 1 of this Article and for the withdrawal of such recognition, or by amending those added criteria; (b) supplementing this Regulation as regards: (i) the exercise of the supervision of the control authorities and control bodies recognised by the Commission in accordance with paragraph 1, including on-the-spot examinations; and (ii) the controls and other actions to be performed by those control authorities and control bodies. 8. The Commission may adopt implementing acts to ensure the application of the measures to be taken in relation to cases of suspected or established non-compliance, in particular those affecting the integrity of organic or in-conversion products imported under the recognition provided for in this Article. Such measures may consist in particular in the verification of the integrity of organic or in-conversion products before placing the products on the market within the Union and, where appropriate, in the suspension of the authorisation for the placing on the market of such products within the Union as organic products or in-conversion products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). 9. On duly justified imperative grounds of urgency relating to unfair practices or practices which are incompatible with the principles and rules on organic production, the protection of consumers’ confidence or the protection of fair competition between operators, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 55(3) to take the measures referred to in paragraph 8 of this Article or to decide on the withdrawal of the recognition of the control authorities and control bodies referred to in paragraph 1 of this Article. Article 47 Equivalence under a trade agreement A recognised third country referred to in point (b)(ii) of Article 45(1) is a third country which the Union has recognised under a trade agreement as having a system of production meeting the same objectives and principles by applying rules which ensure the same level of assurance of conformity as those of the Union. Article 48 Equivalence under Regulation (EC) No 834/2007 1. A recognised third country referred to in point (b)(iii) of Article 45(1) is a third country which has been recognised for the purposes of equivalence under Article 33(2) of Regulation (EC) No 834/2007, including those recognised under the transitional measure provided for in Article 58 of this Regulation. That recognition shall expire on 31 December 2025. 2. On the basis of annual reports to be sent to the Commission, by 31 March of each year, by the third countries referred to in paragraph 1 regarding the implementation and enforcement of the control measures established by them, and in the light of any other information received, the Commission shall ensure appropriate supervision of the recognised third countries by regularly reviewing their recognition. For this purpose, the Commission may request the assistance of Member States. The nature of the supervision shall be determined on the basis of an assessment of the likelihood of non-compliance, taking into account in particular the volume of exports to the Union from the third country concerned, the results of the monitoring and supervisory activities carried out by the competent authority and the results of previous controls. The Commission shall regularly report to the European Parliament and the Council on the outcome of its review. 3. The Commission shall, by means of an implementing act, establish a list of the third countries referred to in paragraph 1 and may amend that list by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). 4. The Commission is empowered to adopt delegated acts in accordance with Article 54 supplementing this Regulation as regards the information to be sent by the third countries listed in accordance with paragraph 3 of this Article which is necessary for the supervision of their recognition by the Commission, as well as the exercise of that supervision by the Commission, including through on-the-spot examination. 5. The Commission may adopt implementing acts to ensure the application of measures in relation to cases of suspected or established non-compliance, in particular those affecting the integrity of organic or in-conversion products imported from third countries referred to in this Article. Such measures may consist in particular in the verification of the integrity of organic or in-conversion products before placing the products on the market within the Union and, where appropriate, in the suspension of the authorisation for the placing on the market of such products within the Union as organic products or in-conversion products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 49 Report from the Commission on the application of Articles 47 and 48 By 31 December 2021, the Commission shall present a report to the European Parliament and the Council on the state of application of Articles 47 and 48, in particular as regards the recognition of third countries for the purpose of equivalence. CHAPTER VIII GENERAL PROVISIONS SECTION 1 Free movement of organic and in-conversion products Article 50 Non-prohibition and non-restriction of the marketing of organic and in-conversion products Competent authorities, control authorities and control bodies shall not, on grounds that relate to the production, labelling or presentation of the products, prohibit or restrict the marketing of organic or in-conversion products subject to control by another competent authority, control authority or control body located in another Member State where those products comply with this Regulation. In particular, no official controls and other official activities other than those under Regulation (EU) 2017/625 shall be performed and no fees for official controls and other official activities other than those provided for in Chapter VI of that Regulation shall be collected. SECTION 2 Information, reporting and related derogations Article 51 Information relating to the organic sector and trade 1. Each year Member States shall transmit to the Commission the information necessary for the implementation and monitoring of the application of this Regulation. As far as possible, such information shall be based on established sources of data. The Commission shall take into account the data needs and synergies between potential data sources, in particular their use for statistical purposes where appropriate. 2. The Commission shall adopt implementing acts as regards the system to be used for transmitting the information referred to in paragraph 1, the details of information to be transmitted, and the date by which that information is to be transmitted. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). Article 52 Information relating to the competent authorities, control authorities and control bodies 1. Members States shall keep a regularly updated list of: (a) the names and addresses of the competent authorities; and (b) the names, addresses and code numbers of the control authorities and control bodies. Member States shall transmit those lists, and any change thereof, to the Commission and make them public, except where such transmission and publication has already taken place in accordance with Article 4(4) of Regulation (EU) 2017/625. 2. Based on the information provided for under paragraph 1, the Commission shall regularly publish on the internet an updated list of control authorities and control bodies referred to in point (b) of paragraph 1. Article 53 Derogations, authorisations and report 1. The derogations from the use of organic plant reproductive material and from the use of organic animals provided in points 1.8.5 of Part I of Annex II and points 1.3.4.3 and 1.3.4.4 of Part II of Annex II, with the exception of point 1.3.4.4.2 of Part II of Annex II, shall expire on 31 December 2035. 2. From 1 January 2028, based on the conclusions as regards availability of organic plant reproductive material and animals presented in the report provided for in paragraph 7 of this Article, the Commission shall be empowered to adopt delegated acts in accordance with Article 54 amending this Regulation by: (a) ending the derogations referred to in point 1.8.5 of Part I of Annex II and in points 1.3.4.3 and 1.3.4.4 of Part II of Annex II, with the exception of point 1.3.4.4.2 of Part II of Annex II, at an earlier date than 31 December 2035 or extending them beyond that date; or (b) ending the derogation referred to in point 1.3.4.4.2 of Part II of Annex II. 3. From 1 January 2026, the Commission shall be empowered to adopt delegated acts in accordance with Article 54 amending point (b) of Article 26(2) to extend the scope of the information system referred to in Article 26(2) to pullets and point 1.3.4.3 of Part II of Annex II to base the derogations concerning pullets on the data collected in accordance with this system. 4. From 1 January 2025, the Commission shall be empowered to adopt delegated acts in accordance with Article 54, based on the information as regards availability of organic protein feed for poultry and porcine animals made available by Member States in accordance with paragraph 6 of this Article or presented in the report referred to in paragraph 7 of this Article, ending the authorisations to use non-organic protein feed in the nutrition of poultry and porcine animals referred to in points 1.9.3.1(c) and 1.9.4.2(c) of Part II of Annex II at an earlier date than 31 December 2025 or extending them beyond that date. 5. When extending the derogations or authorisations referred to in paragraphs 2, 3 and 4, the Commission shall do so only for as long as it has information, in particular information provided by Member States in accordance with paragraph 6, that confirms the unavailability on the Union market of the plant reproductive material, animal or feed concerned. 6. By 30 June of each year, Member States shall make available to the Commission and to the other Member States: (a) information provided in the database referred to in Article 26(1) and in the systems referred to in Article 26(2) and, if relevant, in the systems referred to in Article 26(3); (b) information on the derogations granted in accordance with point 1.8.5 of Part I of Annex II and points 1.3.4.3 and 1.3.4.4 of Part II of Annex II; and (c) information on the availability on the Union market of organic protein feed for poultry and porcine animals and on the authorisations granted in accordance with points 1.9.3.1(c) and 1.9.4.2(c) of Part II of Annex II. 7. By 31 December 2025, the Commission shall present a report to the European Parliament and the Council on the availability on the Union market of and, if relevant, on the causes of limited access to: (a) organic plant reproductive material; (b) organic animals covered by the derogations referred to in points 1.3.4.3 and 1.3.4.4 of Part II of Annex II; (c) organic protein feed intended for the nutrition of poultry and porcine animals subject to the authorisations referred to in points 1.9.3.1(c) and 1.9.4.2(c) of Part II of Annex II. In drawing up that report, the Commission shall take into account, in particular, the data collected in accordance with Article 26 and the information relating to the derogations and the authorisations referred to in paragraph 6 of this Article. CHAPTER IX PROCEDURAL, TRANSITIONAL AND FINAL PROVISIONS SECTION 1 Procedural provisions Article 54 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 2(6), Article 9(11), Article 10(5), Article 12(2), Article 13(3), Article 14(2), Article 15(2), Article 16(2), Article 17(2), Article 18(2), Article 19(2), Article 21(1), Article 22(1), Article 23(2), Article 24(6), Article 30(7), Article 32(4), Article 33(6), Article 34(8), Article 35(9), Article 36(3), Article 38(8), Article 40(11), Article 44(2), Article 46(7), Article 48(4), Article 53(2), (3) and (4), Article 57(3) and Article 58(2) shall be conferred on the Commission for a period of five years from 1 January 2021. The Commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 2(6), Article 9(11), Article 10(5), Article 12(2), Article 13(3), Article 14(2), Article 15(2), Article 16(2), Article 17(2), Article 18(2), Article 19(2), Article 21(1), Article 22(1), Article 23(2), Article 24(6), Article 30(7), Article 32(4), Article 33(6), Article 34(8), Article 35(9), Article 36(3), Article 38(8), Article 40(11), Article 44(2), Article 46(7), Article 48(4), Article 53(2), (3) and (4), Article 57(3) and Article 58(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 2(6), Article 9(11), Article 10(5), Article 12(2), Article 13(3), Article 14(2), Article 15(2), Article 16(2), Article 17(2), Article 18(2), Article 19(2), Article 21(1), Article 22(1), Article 23(2), Article 24(6), Article 30(7), Article 32(4), Article 33(6), Article 34(8), Article 35(9), Article 36(3), Article 38(8), Article 40(11), Article 44(2), Article 46(7), Article 48(4), Article 53(2), (3) and (4), Article 57(3) and Article 58(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 55 Committee procedure 1. The Commission shall be assisted by a committee called the ‘Organic Production Committee’. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. 4. Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. SECTION 2 Repeal and transitional and final provisions Article 56 Repeal Regulation (EC) No 834/2007 is repealed. However, that Regulation shall continue to apply for the purpose of completing the examination of pending applications from third countries, as provided for in Article 58 of this Regulation. References to the repealed Regulation shall be construed as references to this Regulation. Article 57 Transitional measures relating to control authorities and control bodies recognised under Article 33(3) of Regulation (EC) No 834/2007 1. The recognition of control authorities and control bodies granted under Article 33(3) of Regulation (EC) No 834/2007 shall expire by 31 December 2023 at the latest. 2. The Commission shall, by means of an implementing act, establish a list of the control authorities and control bodies recognised under Article 33(3) of Regulation (EC) No 834/2007, and may amend that list by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2). 3. The Commission is empowered to adopt delegated acts in accordance with Article 54 supplementing this Regulation as regards the information to be sent by the control authorities and control bodies referred to in paragraph 2 of this Article which is necessary for the purpose of the supervision of their recognition by the Commission, as well as the exercise of that supervision by the Commission, including through on-the-spot examination. Article 58 Transitional measures relating to applications from third countries submitted under Article 33(2) of Regulation (EC) No 834/2007 1. The Commission shall complete the examination of applications from third countries which have been submitted under Article 33(2) of Regulation (EC) No 834/2007 and which are pending on 17 June 2018. That Regulation shall apply to the examination of such applications. 2. The Commission is empowered to adopt delegated acts in accordance with Article 54 supplementing this Regulation by laying down the procedural rules necessary for the examination of the applications referred to in paragraph 1 of this Article, including on the information to be submitted by third countries. Article 59 Transitional measures relating to the first recognition of control authorities and control bodies By way of derogation from the date of application referred to in the second paragraph of Article 61, Article 46 shall apply from 17 June 2018 insofar as necessary in order to allow a timely recognition of control authorities and control bodies. Article 60 Transitional measures for stocks of organic products produced in accordance with Regulation (EC) No 834/2007 Products produced in accordance with Regulation (EC) No 834/2007 before 1 January 2021 may be placed on the market after that date until stocks are exhausted. Article 61 Entry into force and application This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 30 May 2018. For the European Parliament The President A. TAJANI For the Council The President L. PAVLOVA (1) OJ C 12, 15.1.2015, p. 75. (2) OJ C 19, 21.1.2015, p. 84. (3) Position of the European Parliament of 19 April 2018 (not yet published in the Official Journal) and decision of the Council of 22 May 2018. (4) Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (OJ L 343, 14.12.2012, p. 1). (5) Regulation (EU) No 228/2013 of the European Parliament and of the Council of 13 March 2013 laying down specific measures for agriculture in the outermost regions of the Union and repealing Council Regulation (EC) No 247/2006 (OJ L 78, 20.3.2013, p. 23). (6) Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009 (OJ L 347, 20.12.2013, p. 608). (7) Regulation (EU) No 1305/2013 of the European Parliament and of the Council of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 (OJ L 347, 20.12.2013, p. 487). (8) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). (9) Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission ceilings for certain atmospheric pollutants (OJ L 309, 27.11.2001, p. 22). (10) Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71). (11) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). (12) Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1). (13) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). (14) Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1). (15) OJ L 123, 12.5.2016, p. 1. (16) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). (17) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1). (18) Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (OJ 125, 11.7.1966, p. 2298). (19) Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (OJ 125, 11.7.1966, p. 2309). (20) Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative propagation of the vine (OJ L 93, 17.4.1968, p. 15). (21) Council Directive 98/56/EC of 20 July 1998 on the marketing of propagating material of ornamental plants (OJ L 226, 13.8.1998, p. 16). (22) Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (OJ L 193, 20.7.2002, p. 1). (23) Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed (OJ L 193, 20.7.2002, p. 12). (24) Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (OJ L 193, 20.7.2002, p. 33). (25) Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes (OJ L 193, 20.7.2002, p. 60). (26) Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (OJ L 193, 20.7.2002, p. 74). (27) Council Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable propagating and planting material, other than seed (OJ L 205, 1.8.2008, p. 28). (28) Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (OJ L 267, 8.10.2008, p. 8). (29) Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control (OJ L 250, 18.9.2008, p. 1). (30) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18). (31) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (32) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671). (33) Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (OJ L 227, 1.9.1994, p. 1). (34) Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p. 4). (35) Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens (OJ L 203, 3.8.1999, p. 53). (36) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). (37) Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19). (38) Council Regulation (EC) No 708/2007 of 11 June 2007 concerning use of alien and locally absent species in aquaculture (OJ L 168, 28.6.2007, p. 1). (39) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1). (40) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). (41) Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, p. 1). (42) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1). (43) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16). (44) Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29). (45) Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1). (46) Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97 (OJ L 354, 31.12.2008, p. 7). (47) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1). (48) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1). (49) Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1). (50) Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, p. 24). (51) Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34). (52) Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (OJ L 328, 24.11.2006, p. 14). (53) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (54) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (55) Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, p. 549). ANNEX I OTHER PRODUCTS REFERRED TO IN ARTICLE 2(1) — Yeasts used as food or feed, — maté, sweetcorn, vine leaves, palm hearts, hop shoots, and other similar edible parts of plants and products produced therefrom, — sea salt and other salts for food and feed, — silkworm cocoon suitable for reeling, — natural gums and resins, — beeswax, — essential oils, — cork stoppers of natural cork, not agglomerated, and without any binding substances, — cotton, not carded or combed, — wool, not carded or combed, — raw hides and untreated skins, — plant-based traditional herbal preparations. ANNEX II DETAILED PRODUCTION RULES REFERRED TO IN CHAPTER III Part I: Plant production rules In addition to the production rules laid down in Articles 9 to 12, the rules set out in this Part shall apply to organic plant production. 1. General requirements 1.1. Organic crops, except those which are naturally grown in water, shall be produced in living soil, or in living soil mixed or fertilised with materials and products allowed in organic production, in connection with the subsoil and bedrock. 1.2. Hydroponic production, which is a method of growing plants which do not naturally grow in water with their roots in a nutrient solution only or in an inert medium to which a nutrient solution is added, is prohibited. 1.3. By way of derogation from point 1.1, the production of sprouts by moistening of seeds and the obtaining of chicory heads including by dipping in clear water shall be allowed. 1.4. By way of derogation from point 1.1, the following practices shall be allowed: (a) growing plants for the production of ornamentals and herbs in pots to be sold together with the pot to the final consumer; (b) growing seedlings or transplants in containers for further transplanting. 1.5. By way of derogation from point 1.1, growing crops in demarcated beds shall only be allowed for the surfaces that have been certified as organic for that practice before 28 June 2017 in Finland, Sweden and Denmark. No extension of those surfaces shall be permitted. That derogation shall expire on 31 December 2030. By 31 December 2025, the Commission shall present a report to the European Parliament and the Council on the use of demarcated beds in organic agriculture. That report may be accompanied, where appropriate, by a legislative proposal on the use of demarcated beds in organic agriculture. 1.6. All plant production techniques used shall prevent or minimise any contribution to the contamination of the environment. 1.7. Conversion 1.7.1. For plants and plant products to be considered as organic products, the production rules laid down in this Regulation shall have been applied with respect to the parcels during a conversion period of at least two years before sowing, or, in the case of grassland or perennial forage, during a period of at least two years before its use as organic feed, or, in the case of perennial crops other than forage, during a period of at least three years before the first harvest of organic products. 1.7.2. Where the land or one or more parcels thereof have been contaminated with products or substances not authorised for use in organic production, the competent authority may decide to extend the conversion period for the land or parcels concerned beyond the period referred to in point 1.7.1. 1.7.3. In the case of treatment with a product or a substance not authorised for use in organic production, the competent authority shall require a new conversion period in accordance with point 1.7.1. That period may be shortened in the following two cases: (a) treatment with a product or a substance not authorised for use in organic production as part of a compulsory control measure for pests or weeds, including quarantine organisms or invasive species, imposed by the competent authority of the Member State concerned; (b) treatment with a product or a substance not authorised for use in organic production as part of scientific tests approved by the competent authority of the Member State concerned. 1.7.4. In the cases referred to in points 1.7.2 and 1.7.3, the length of the conversion period shall be fixed taking into account the following requirements: (a) the process of degradation of the product or substance concerned must guarantee, at the end of the conversion period, an insignificant level of residues in the soil and, in the case of a perennial crop, in the plant; (b) the harvest following the treatment may not be placed on the market as organic or in-conversion products. 1.7.4.1. Member States shall inform the Commission and the other Member States of any decision taken by them which lays down compulsory measures related to treatment with a product or a substance not authorised for use in organic production. 1.7.4.2. In the case of treatment with a product or a substance which is not authorised for use in organic production, point 1.7.5(b) shall not apply. 1.7.5. In the case of land associated with organic livestock production: (a) the conversion rules shall apply to the whole area of the production unit on which animal feed is produced; (b) notwithstanding point (a), the conversion period may be reduced to one year for pasturages and open air areas used by non-herbivore species. 1.8. Origin of plants including plant reproductive material 1.8.1. For the production of plants and plant products other than plant reproductive material, only organic plant reproductive material shall be used. 1.8.2. To obtain organic plant reproductive material to be used for the production of products other than plant reproductive material, the mother plant and, where relevant, other plants intended for plant reproductive material production shall have been produced in accordance with this Regulation for at least one generation, or, in the case of perennial crops, for at least one generation during two growing seasons. 1.8.3. When choosing organic plant reproductive material, operators shall give preference to organic plant reproductive material suitable for organic agriculture. 1.8.4. For the production of organic varieties suitable for organic production, the organic breeding activities shall be conducted under organic conditions and shall focus on enhancement of genetic diversity, reliance on natural reproductive ability, as well as agronomic performance, disease resistance and adaptation to diverse local soil and climate conditions. All multiplication practices except meristem culture shall be carried out under certified organic management. 1.8.5. Use of in-conversion and non-organic plant reproductive material 1.8.5.1. By way of derogation from point 1.8.1, where the data collected in the database referred to in Article 26(1) or the system referred to in point (a) of Article 26(2) shows that the qualitative or quantitative needs of the operator regarding relevant organic plant reproductive material, excluding seedlings, are not met, competent authorities may authorise the use of in-conversion or non-organic plant reproductive material under the conditions laid down in points 1.8.5.3, 1.8.5.4 and 1.8.5.5. Prior to requesting any such derogation, the operator shall consult the database referred to in Article 26(1) or the system referred to in point (a) of Article 26(2) in order to verify whether his or her request is justified. 1.8.5.2. Control authorities or control bodies recognised in accordance with Article 46(1) may authorise operators in third countries to use in-conversion or non-organic plant reproductive material in an organic production unit when organic plant reproductive material is not available in sufficient quality or quantity in the territory of the third country in which the operator is located, under the conditions laid down under points 1.8.5.3, 1.8.5.4 and 1.8.5.5. 1.8.5.3. Non-organic plant reproductive material shall not be treated with plant protection products other than those authorised for the treatment of seed in accordance with Article 24(1) of this Regulation, unless chemical treatment has been prescribed in accordance with Regulation (EU) 2016/2031 for phytosanitary purposes by the competent authority of the Member State concerned for all varieties of a given species in the area in which the plant reproductive material is to be used. 1.8.5.4. The authorisation to use in-conversion or non-organic plant reproductive material shall be obtained before the sowing of the crop. 1.8.5.5. The authorisation to use in-conversion or non-organic plant reproductive material shall be granted only to individual users for one season at a time, and the competent authority responsible for authorisations shall list the quantities of the authorised plant reproductive material. 1.9. Soil management and fertilisation 1.9.1. In organic plant production, tillage and cultivation practices shall be used that maintain or increase soil organic matter, enhance soil stability and soil biodiversity, and prevent soil compaction and soil erosion. 1.9.2. The fertility and biological activity of the soil shall be maintained and increased: (a) except in the case of grassland or perennial forage, by the use of multiannual crop rotation including mandatory leguminous crops as the main or cover crop for rotating crops and other green manure crops; (b) in the case of greenhouses or perennial crops other than forage, by the use of short-term green manure crops and legumes as well as the use of plant diversity; and (c) in all cases, by the application of livestock manure or organic matter, both preferably composted, from organic production. 1.9.3. Where the nutritional needs of plants cannot be met by the measures provided for in points 1.9.1 and 1.9.2, only fertilisers and soil conditioners that have been authorised pursuant to Article 24 for use in organic production shall be used, and only to the extent necessary. Operators shall keep records of the use of those products. 1.9.4. The total amount of livestock manure, as defined in Directive 91/676/EEC, used in the in-conversion and organic production units shall not exceed 170 kg of nitrogen per year/hectare of agricultural area used. That limit shall only apply to the use of farmyard manure, dried farmyard manure and dehydrated poultry manure, composted animal excrement, including poultry manure, composted farmyard manure and liquid animal excrement. 1.9.5. Operators of agricultural holdings may establish written cooperation agreements exclusively with operators of other agricultural holdings and undertakings which comply with the organic production rules, for the purpose of spreading surplus manure from organic production units. The maximum limit referred to in point 1.9.4 shall be calculated on the basis of all of the organic production units involved in such cooperation. 1.9.6. Preparations of micro-organisms may be used to improve the overall condition of the soil or to improve the availability of nutrients in the soil or in the crops. 1.9.7. For compost activation, appropriate plant-based preparations and preparations of micro-organisms may be used. 1.9.8. Mineral nitrogen fertilisers shall not be used. 1.9.9. Biodynamic preparations may be used. 1.10. Pest and weed management 1.10.1. The prevention of damage caused by pests and weeds shall rely primarily on the protection by: — natural enemies, — the choice of species, varieties and heterogeneous material, — crop rotation, — cultivation techniques such as biofumigation, mechanical and physical methods, and — thermal processes such as solarisation and, in the case of protected crops, shallow steam treatment of the soil (to a maximum depth of 10 cm). 1.10.2. Where plants cannot adequately be protected from pests by measures provided for in point 1.10.1 or in the case of an established threat to a crop, only products and substances authorised pursuant to Articles 9 and 24 for use in organic production shall be used, and only to the extent necessary. Operators shall keep records proving the need for the use of such products. 1.10.3. In relation to products and substances used in traps or in dispensers of products and substances other than pheromones, the traps or dispensers shall prevent the products and substances from being released into the environment and shall prevent contact between the products and substances and the crops being cultivated. All traps, including pheromone traps, shall be collected after use and shall be safely disposed of. 1.11. Products used for cleaning and disinfection Only those products for cleaning and disinfection in plant production authorised pursuant to Article 24 for use in organic production shall be used for that purpose. 1.12. Record-keeping obligation Operators shall keep records regarding the parcels concerned and the amount of the harvest. 1.13. Preparation of unprocessed products If preparation operations other than processing are carried out on plants, the general requirements laid down in points 1.2, 1.3, 1.4, 1.5 and 2.2.3 of Part IV shall apply mutatis mutandis to such operations. 2. Detailed rules for specific plants and plant products 2.1. Rules on mushroom production For the production of mushrooms, substrates may be used if they are composed only of the following components: (a) farmyard manure and animal excrement: (i) either from organic production units or from in-conversion units in their second year of conversion; or (ii) referred to in point 1.9.3, only when the product referred to in point (i) is not available, provided that that farmyard manure and animal excrement do not exceed 25 % of the weight of total components of the substrate, excluding the covering material and any added water, before composting; (b) products of agricultural origin, other than those referred to in point (a), from organic production units; (c) peat, not treated with chemical products; (d) wood, not treated with chemical products after felling; (e) mineral products referred to in point 1.9.3, water and soil. 2.2. Rules concerning the collection of wild plants The collection of wild plants and parts thereof growing naturally in natural areas, forests and agricultural areas is considered as organic production, provided that: (a) for a period of at least three years before the collection, those areas were not treated with products or substances other than those authorised pursuant to Articles 9 and 24 for use in organic production; (b) the collection does not affect the stability of the natural habitat or the maintenance of the species in the collection area. Part II: Livestock production rules In addition to the production rules laid down in Articles 9, 10, 11 and 14, the rules laid down in this Part shall apply to organic livestock production. 1. General requirements 1.1. Except in the case of beekeeping, landless livestock production, where the farmer intending to produce organic livestock does not manage agricultural land and has not established a written cooperation agreement with a farmer as regards the use of organic production units or in-conversion production units for that livestock, shall be prohibited. 1.2. Conversion 1.2.1. In the case of simultaneous start of conversion of the production unit, including pasturage or any land used for animal feed, and of the animals existing on this production unit at the beginning of the conversion period of this production unit as referred to in points 1.7.1 and 1.7.5(b) of Part I, animals and animal products may be considered organic at the end of the conversion period of the production unit, even if the conversion period laid down in point 1.2.2 of this Part for the type of animal concerned is longer than the conversion period for the production unit. By derogation from point 1.4.3.1, in the case of such simultaneous conversion and during the conversion period of the production unit, animals present in this production unit since the beginning of the conversion period may be fed with in-conversion feed produced on the in-conversion production unit during the first year of conversion and/or with feed in accordance with point 1.4.3.1 and/or with organic feed. Non-organic animals may be introduced into an in-conversion production unit after the start of the conversion period in accordance with point 1.3.4. 1.2.2. Conversion periods specific to the type of animal production are set out as follows: (a) 12 months in the case of bovine animals and equine animals for meat production, and in any case no less than three quarters of their lifetime; (b) six months in the case of ovine animals, caprine animals and porcine animals and animals for milk production; (c) 10 weeks for poultry for meat production, except for Peking ducks, brought in before they are three days old; (d) seven weeks for Peking ducks brought in before they are three days old; (e) six weeks in the case of poultry for egg production brought in before they are three days old; (f) 12 months for bees. During the conversion period, the wax shall be replaced with wax coming from organic beekeeping. However, non-organic beeswax may be used: (i) where beeswax from organic beekeeping is not available on the market; (ii) where it is proven free of contamination with products or substances not authorised for use in organic production; and (iii) provided that it comes from the cap; (g) three months for rabbits; (h) 12 months for cervine animals. 1.3. Origin of animals 1.3.1. Without prejudice to the rules on conversion, organic livestock shall be born or hatched and raised on organic production units. 1.3.2. With regard to the breeding of organic animals: (a) reproduction shall use natural methods; however, artificial insemination shall be allowed; (b) reproduction shall not be induced or impeded by treatment with hormones or other substances with a similar effect, except as a form of veterinary therapeutic treatment in the case of an individual animal; (c) other forms of artificial reproduction, such as cloning and embryo transfer, shall not be used; (d) the choice of breeds shall be appropriate to the principles of organic production, shall ensure a high standard of animal welfare and shall contribute to the prevention of any suffering and to avoiding the need for the mutilation of animals. 1.3.3. When choosing breeds or strains, operators shall consider giving preference to breeds or strains with a high degree of genetic diversity, the capacity of animals to adapt to local conditions, their breeding value, their longevity, their vitality and their resistance to disease or health problems, all without impairment of their welfare. In addition, breeds or strains of animals shall be selected to avoid specific diseases or health problems associated with some breeds or strains used in intensive production, such as porcine stress syndrome, possibly leading to pale-soft-exudative (PSE) meat, sudden death, spontaneous abortion and difficult births requiring caesarean operations. Preference shall be given to indigenous breeds and strains. To choose the breeds and strains in accordance with the first paragraph, operators shall use the information available in the systems referred to in Article 26(3). 1.3.4. Use of non-organic animals 1.3.4.1. By way of derogation from point 1.3.1, for breeding purposes, non-organically raised animals may be brought to an organic production unit when breeds are in danger of being lost to farming as referred to in point (b) of Article 28(10) of Regulation (EU) No 1305/2013 and acts adopted on the basis thereof. In such case, the animals of those breeds need not necessarily be nulliparous. 1.3.4.2. By way of derogation from point 1.3.1, for the renovation of apiaries, 20 % per year of the queen bees and swarms may be replaced by non-organic queen bees and swarms in the organic production unit, provided that the queen bees and swarms are placed in hives with combs or comb foundations coming from organic production units. In any case, one swarm or queen bee may be replaced per year by a non-organic swarm or a queen bee. 1.3.4.3. By way of derogation from point 1.3.1, where a flock is constituted for the first time, or is renewed or reconstituted, and where the qualitative and quantitative needs of farmers cannot be met, the competent authority may decide that non-organically reared poultry may be brought into an organic poultry production unit, provided that the pullets for the production of eggs and poultry for meat production are less than three days old. Products derived from them may only be considered as organic if the conversion period specified in point 1.2 has been complied with. 1.3.4.4. By way of derogation from point 1.3.1, where the data collected in the system referred to in point (b) of Article 26(2) shows that the qualitative or quantitative needs of the farmer regarding organic animals are not met, competent authorities may authorise the introduction of non-organic animals into an organic production unit, subject to the conditions provided for in points 1.3.4.4.1 to 1.3.4.4.4. Prior to requesting any such derogation, the farmer shall consult the data collected in the system referred to in point (b) of Article 26(2) in order to verify whether his or her request is justified. For operators in third countries, control authorities and control bodies recognised in accordance with Article 46(1) may authorise the introduction of non-organic animals into an organic production unit where organic animals are not available in sufficient quality or quantity in the territory of the country where the operator is located. 1.3.4.4.1. For breeding purposes, non-organic young animals may be introduced when a herd or flock is constituted for the first time. They shall be reared in accordance with the organic production rules immediately after they are weaned. In addition, the following restrictions shall apply on the date on which those animals enter the herd or flock: (a) bovine animals, equine animals and cervine animals shall be less than six months old; (b) ovine animals and caprine animals shall be less than 60 days old; (c) porcine animals shall weigh less than 35 kg; (d) rabbits shall be less than three months old. 1.3.4.4.2. For breeding purposes, non-organic adult male and non-organic nulliparous female animals may be introduced for the renewal of a herd or flock. They shall be reared subsequently in accordance with the organic production rules. In addition, the number of female animals shall be subject to the following restrictions per year: (a) up to a maximum of 10 % of adult equine animals or bovine animals and 20 % of the adult porcine animals, ovine animals, caprine animals, rabbits or cervine animals may be introduced; (b) for units with fewer than 10 equine animals, cervine animals or bovine animals or rabbits, or with fewer than five porcine animals, ovine animals or caprine animals, any such renewal shall be limited to a maximum of one animal per year. 1.3.4.4.3. The percentages set in point 1.3.4.4.2 may be increased up to 40 %, provided that the competent authority has confirmed that any of following conditions is fulfilled: (a) a major extension to the farm has been undertaken; (b) one breed has been replaced with another; (c) a new livestock specialisation has been initiated. 1.3.4.4.4. In the cases referred to in points 1.3.4.4.1, 1.3.4.4.2 and 1.3.4.4.3, non-organic animals may only be considered as organic if the conversion period specified in point 1.2 has been complied with. The conversion period laid down in point 1.2.2 shall start, at the earliest, once the animals are introduced into the in-conversion production unit. 1.3.4.4.5. In the cases referred to in points 1.3.4.4.1 to 1.3.4.4.4, non-organic animals shall either be kept separate from other livestock or shall be kept identifiable until the end of the conversion period referred to in point 1.3.4.4.4. 1.4. Nutrition 1.4.1. General nutrition requirements With regard to nutrition, the following rules shall apply: (a) feed for livestock shall be obtained primarily from the agricultural holding where the animals are kept or shall be obtained from organic or in-conversion production units belonging to other holdings in the same region; (b) livestock shall be fed with organic or in-conversion feed that meets the animal’s nutritional requirements at the various stages of its development; restricted feeding shall not be permitted in livestock production unless justified for veterinary reasons; (c) livestock shall not be kept in conditions or on a diet which may encourage anaemia; (d) fattening practices shall always respect the normal nutritional patterns for each species and the animals’ welfare at each stage of the rearing process; force-feeding is forbidden; (e) with the exception of porcine animals, poultry and bees, livestock shall have permanent access to pasture whenever conditions allow or shall have permanent access to roughage; (f) growth promoters and synthetic amino-acids shall not be used; (g) suckling animals shall preferably be fed on maternal milk for a minimum period laid down by the Commission in accordance with point (a) of Article 14(3); milk replacers containing chemically synthesised components or components of plant origin shall not be used during that period; (h) feed materials of plant, algal, animal or yeast origin shall be organic; (i) non-organic feed materials of plant, algal, animal or yeast origin, feed materials of microbial or of mineral origin, feed additives and processing aids may be used only if they have been authorised pursuant to Article 24 for use in organic production. 1.4.2. Grazing 1.4.2.1. Grazing on organic land Without prejudice to point 1.4.2.2, organic animals shall graze on organic land. However, non-organic animals may use organic pasturage for a limited period each year, provided that they have been raised in an environmental friendly way on land supported under Articles 23, 25, 28, 30, 31 and 34 of Regulation (EU) No 1305/2013 and that they are not present on the organic land at the same time as organic animals. 1.4.2.2. Grazing on common land and transhumance 1.4.2.2.1. Organic animals may graze on common land, provided that: (a) the common land has not been treated with products or substances not authorised for use in organic production for at least three years; (b) any non-organic animals which use the common land have been raised in an environmental friendly way on land supported under Articles 23, 25, 28, 30, 31 and 34 of Regulation (EU) No 1305/2013; (c) any livestock products from organic animals that were produced during the period when those animals grazed on common land are not considered as organic products unless adequate segregation from non-organic animals can be proved. 1.4.2.2.2. During the period of transhumance, organic animals may graze on non-organic land when they are being moved on foot from one grazing area to another. During that period, organic animals shall be kept separate from other animals. The uptake of non-organic feed, in the form of grass and other vegetation on which the animals graze, shall be allowed: (a) for a maximum of 35 days covering both the outward and return journeys; or (b) for a maximum of 10 % of the total feed ration per year, calculated as a percentage of the dry matter of feedstuffs of agricultural origin. 1.4.3. In-conversion feed 1.4.3.1. For agricultural holdings that produce organic livestock: (a) up to 25 % on average of the feed formula of rations may comprise in-conversion feed from the second year of conversion. This percentage may be increased to 100 % if this in-conversion feed comes from the holding where the livestock is kept; and (b) up to 20 % of the total average amount of feed fed to livestock may originate from the grazing or harvesting of permanent pastures, perennial forage parcels or protein crops sown under organic management on lands in their first year of conversion, provided that those lands are part of the holding itself. When both types of in-conversion feed referred to in points (a) and (b) are being used for feeding, the total combined percentage of such feed shall not exceed the percentage fixed in point (a). 1.4.3.2. The figures in point 1.4.3.1 shall be calculated annually as a percentage of the dry matter of feed of plant origin. 1.5. Health care 1.5.1. Disease prevention 1.5.1.1. Disease prevention shall be based on breed and strain selection, husbandry management practices, high-quality feed, exercise, appropriate stocking density and adequate and appropriate housing maintained in hygienic conditions. 1.5.1.2. Immunological veterinary medicinal products may be used. 1.5.1.3. Chemically synthesised allopathic veterinary medicinal products, including antibiotics and boluses of synthesised allopathic chemical molecules, shall not be used for preventive treatment. 1.5.1.4. Substances to promote growth or production (including antibiotics, coccidiostatics and other artificial aids for growth promotion purposes) and hormones and similar substances for the purpose of controlling reproduction or for other purposes (e.g. induction or synchronisation of oestrus) shall not be used. 1.5.1.5. Where livestock is obtained from non-organic production units, special measures such as screening tests or quarantine periods shall apply, depending on local circumstances. 1.5.1.6. Only the products for cleaning and disinfection in livestock buildings and installations authorised pursuant to Article 24 for use in organic production shall be used for that purpose. 1.5.1.7. Housing, pens, equipment and utensils shall be properly cleaned and disinfected to prevent cross-infection and the build-up of disease carrying organisms. Faeces, urine and uneaten or spilt feed shall be removed as often as necessary to minimise smell and to avoid attracting insects or rodents. Rodenticides, to be used only in traps, and products and substances authorised pursuant to Articles 9 and 24 for use in organic production may be used for the elimination of insects and other pests in buildings and other installations where livestock are kept. 1.5.2. Veterinary treatment 1.5.2.1. Where animals become sick or injured despite preventive measures to ensure animal health, they shall be treated immediately. 1.5.2.2. Disease shall be treated immediately to avoid suffering of the animal. Chemically synthesised allopathic veterinary medicinal products, including antibiotics, may be used where necessary, under strict conditions and under the responsibility of a veterinarian, when the use of phytotherapeutic, homeopathic and other products is inappropriate. In particular, restrictions with respect to courses of treatment and withdrawal periods shall be defined. 1.5.2.3. Feed materials of mineral origin authorised pursuant to Article 24 for use in organic production, nutritional additives authorised pursuant to Article 24 for use in organic production, and phytotherapeutic and homeopathic products shall be used in preference to treatment with chemically synthesised allopathic veterinary medicinal products, including antibiotics, provided that their therapeutic effect is effective for the species of animal and for the condition for which the treatment is intended. 1.5.2.4. With the exception of vaccinations, treatments for parasites and compulsory eradication schemes, where an animal or a group of animals receives more than three courses of treatments with chemically synthesised allopathic veterinary medicinal products, including antibiotics, within 12 months, or more than one course of treatment if their productive lifecycle is less than one year, neither the livestock concerned nor produce derived from such livestock shall be sold as organic products, and the livestock shall be subject to the conversion periods referred to in point 1.2. 1.5.2.5. The withdrawal period between the last administration to an animal of a chemically synthesised allopathic veterinary medicinal product, including of an antibiotic, under normal conditions of use, and the production of organically produced foodstuffs from that animal shall be twice the withdrawal period referred to in Article 11 of Directive 2001/82/EC, and shall be at least 48 hours. 1.5.2.6. Treatments related to the protection of human and animal health imposed on the basis of Union legislation shall be allowed. 1.6. Housing and husbandry practices 1.6.1. Insulation, heating and ventilation of the building shall ensure that air circulation, dust level, temperature, relative air humidity and gas concentration are kept within limits which ensure the well-being of the animals. The building shall permit plentiful natural ventilation and light to enter. 1.6.2. Housing for livestock shall not be mandatory in areas with appropriate climatic conditions enabling animals to live outdoors. In such cases, animals shall have access to shelters or shady areas to protect them from adverse weather conditions. 1.6.3. The stocking density in buildings shall provide for the comfort, well-being and species-specific needs of the animals, and shall depend in particular on the species, the breed and the age of the animals. It shall also take account of the behavioural needs of the animals, which depend in particular on the size of the group and the animals’ sex. The density shall ensure the animals’ welfare by providing them with sufficient space to stand naturally, to move, to lie down easily, to turn round, to groom themselves, to assume all natural postures and to make all natural movements, such as stretching and wing flapping. 1.6.4. The minimum surface for indoor and outdoor areas, and the technical details relating to housing, laid down in the implementing acts referred to in Article 14(3), shall be complied with. 1.6.5. Open air areas may be partially covered. Verandas shall not be considered as open air areas. 1.6.6. The total stocking density shall not exceed the limit of 170 kg of organic nitrogen per year and hectare of agricultural area. 1.6.7. To determine the appropriate density of livestock referred to in point 1.6.6, the competent authority shall set out the livestock units equivalent to the limit referred to in point 1.6.6, following the figures laid down in each of the specific requirements per type of animal production. 1.6.8. Cages, boxes and flat decks to raise livestock shall not be used for any livestock species. 1.6.9. When livestock is treated individually for veterinary reasons, it shall be kept in spaces that have a solid floor and shall be provided with straw or appropriate bedding. The animal must be able to turn around easily and to lie down comfortably at full length. 1.6.10. Organic livestock may not be reared in a pen on very wet or marshy soil. 1.7. Animal welfare 1.7.1. All persons involved in keeping animals and in handling animals during transport and slaughter shall possess the necessary basic knowledge and skills as regards the health and the welfare needs of the animals and shall have followed adequate training, as required in particular in Council Regulation (EC) No 1/2005 (1) and Council Regulation No (EC) 1099/2009 (2), to ensure proper application of the rules set out in this Regulation. 1.7.2. Husbandry practices, including stocking densities and housing conditions, shall ensure that the developmental, physiological and ethological needs of the animals are met. 1.7.3. Livestock shall have permanent access to open air areas that allow the animals to exercise, preferably pasture, whenever weather and seasonal conditions and the state of the ground allow, except where restrictions and obligations related to the protection of human and animal health have been imposed on the basis of Union legislation. 1.7.4. The number of livestock shall be limited with a view to minimising overgrazing, poaching of soil, erosion, and pollution caused by animals or by the spreading of their manure. 1.7.5. Tethering or isolation of livestock shall be prohibited, except in relation to individual animals for a limited period and insofar as this is justified for veterinary reasons. The isolation of livestock may only be authorised, and only for a limited period, where workers’ safety is compromised or for animal welfare reasons. Competent authorities may authorise the tethering of cattle in farms with a maximum of 50 animals (excluding young stock) where it is not possible to keep the cattle in groups appropriate to their behaviour requirements, provided they have access to pastures during the grazing period, and have access to open air areas at least twice a week when grazing is not possible. 1.7.6. Duration of transport of livestock shall be minimised. 1.7.7. Any suffering, pain and distress shall be avoided and shall be kept to a minimum during the entire life of the animal, including at the time of slaughter. 1.7.8. Without prejudice to developments in Union legislation on animal welfare, tail-docking of sheep, beak trimming undertaken in the first three days of life, and dehorning may exceptionally be allowed, but only on a case-by-case basis and only when those practices improve the health, welfare or hygiene of the livestock or where workers’ safety would otherwise be compromised. Disbudding may be allowed only on a case by case basis when it improves the health, welfare or hygiene of the livestock or where workers’ safety would otherwise be compromised. The competent authority shall only authorise such operations where the operator has duly notified and justified the operations to that competent authority and where the operation is to be carried out by qualified personnel. 1.7.9. Any suffering to the animals shall be reduced to a minimum by applying adequate anaesthesia and/or analgesia and by carrying out each operation at only the most appropriate age by qualified personnel. 1.7.10. Physical castration shall be allowed in order to maintain the quality of products and traditional production practices, but only under the conditions set out in point 1.7.9. 1.7.11. The loading and unloading of animals shall be carried out without the use of any type of electrical or other painful stimulation to coerce the animals. The use of allopathic tranquillisers, prior to or during transport, shall be prohibited. 1.8. Preparation of unprocessed products If preparation operations other than processing are carried out on livestock, the general requirements laid down in points 1.2, 1.3, 1.4, 1.5 and 2.2.3 of Part IV shall apply mutatis mutandis to such operations. 1.9. Additional general rules 1.9.1. For bovine animals, ovine animals, caprine animals and equine animals 1.9.1.1. Nutrition With regard to nutrition, the following rules shall apply: (a) at least 60 % of the feed shall come from the farm itself or, if this is not feasible or such feed is not available, shall be produced in cooperation with other organic or in-conversion production units and feed operators using feed and feed material from the same region. This percentage shall be raised to 70 % as from 1 January 2023; (b) animals shall have access to pasturage for grazing whenever conditions allow; (c) notwithstanding point (b), male bovine animals over one year old shall have access to pasturage or an open air area; (d) where animals have access to pasturage during the grazing period and where the winter housing system allows the animals to move freely, the obligation to provide open air areas during the winter months may be waived; (e) rearing systems shall be based on maximum use of grazing pasturage, by reference to the availability of pastures in the different periods of the year; (f) at least 60 % of the dry matter in daily rations shall consist of roughage, fresh or dried fodder, or silage. This percentage may be reduced to 50 % for animals in dairy production for a maximum period of three months in early lactation. 1.9.1.2. Housing and husbandry practices With regard to housing and husbandry practices, the following rules shall apply: (a) housing shall have smooth, but not slippery floors; (b) housing shall be provided with a comfortable, clean and dry laying or rest area of sufficient size, which shall consist of a solid construction which is not slatted. Ample dry bedding strewn with litter material shall be provided in the rest area. The litter shall comprise straw or other suitable natural material. The litter may be improved and enriched with any mineral product that is authorised pursuant to Article 24 as a fertiliser or soil conditioner for use in organic production; (c) notwithstanding point (a) of the first subparagraph of Article 3(1) and the second subparagraph of Article 3(1) of Council Directive 2008/119/EC (3), the housing of calves in individual boxes shall be forbidden after the age of one week, unless for individual animals for a limited period, and insofar as this is justified for veterinary reasons; (d) when a calf is treated individually for veterinary reasons, it shall be kept in spaces that have a solid floor and shall be provided with straw bedding. The calf must be able to turn around easily and to lie down comfortably at full length. 1.9.2. For cervine animals 1.9.2.1. Nutrition With regard to nutrition, the following rules shall apply: (a) at least 60 % of the feed shall come from the farm itself or, if this is not feasible or such feed is not available, shall be produced in cooperation with other organic or in-conversion production units and feed operators using feed and feed material from the same region. This percentage shall be raised to 70 % as from 1 January 2023; (b) animals shall have access to pasturage for grazing whenever conditions allow; (c) where animals have access to pasturage during the grazing period and where the winter housing system allows the animals to move freely, the obligation to provide open air areas during the winter months may be waived; (d) rearing systems shall be based on maximum use of grazing pasturage by reference to the availability of pastures in the different periods of the year; (e) at least 60 % of the dry matter in daily rations shall consist of roughage, fresh or dried fodder, or silage. This percentage may be reduced to 50 % for female cervine animals in milk production for a maximum period of three months in early lactation; (f) natural grazing shall be ensured in a pen during the period of vegetation. Pens that cannot provide feed by grazing during the period of vegetation shall not be allowed; (g) feeding shall only be allowed in the event of a shortage of grazing due to poor weather conditions; (h) farmed animals in a pen shall be provided with clean and fresh water. If a natural source of water that is easily accessible to animals is not available, watering places shall be provided. 1.9.2.2. Housing and husbandry practices With regard to housing and husbandry practices, the following rules shall apply: (a) cervine animals shall be provided with hiding places, shelters and fences that do not harm animals; (b) in red deer pens, animals must be able to roll in the mud to ensure skin grooming and body temperature regulation; (c) any housing shall have smooth, but not slippery floors; (d) any housing shall be provided with a comfortable, clean and dry laying or rest area of sufficient size, consisting of a solid construction which is not slatted. Ample dry bedding strewn with litter material shall be provided in the rest area. The litter shall comprise straw or other suitable natural material. The litter may be improved and enriched with any mineral product authorised pursuant to Article 24 as a fertiliser or soil conditioner for use in organic production; (e) feeding places shall be installed in areas protected from the weather and accessible both to animals and to persons attending to them. The soil where feeding places are located shall be consolidated, and the feeding apparatus shall be equipped with a roof; (f) if permanent access to feed cannot be ensured, the feeding places shall be designed so that all animals can feed at the same time. 1.9.3. For porcine animals 1.9.3.1. Nutrition With regard to nutrition, the following rules shall apply: (a) at least 30 % of the feed shall come from the farm itself or, if this is not feasible or such feed is not available, shall be produced in cooperation with other organic or in-conversion production units and feed operators using feed and feed material from the same region; (b) roughage, fresh or dried fodder, or silage shall be added to the daily ration; (c) where farmers are unable to obtain protein feed exclusively from organic production, and the competent authority has confirmed that organic protein feed is not available in sufficient quantity, non-organic protein feed may be used until 31 December 2025 provided that the following conditions are fulfilled: (i) it is not available in organic form; (ii) it is produced or prepared without chemical solvents; (iii) its use is limited to the feeding of piglets of up to 35 kg with specific protein compounds; and (iv) the maximum percentage authorised per period of 12 months for those animals does not exceed 5 %. The percentage of the dry matter of feed from agricultural origin shall be calculated. 1.9.3.2. Housing and husbandry practices With regard to housing and husbandry practices, the following rules shall apply: (a) the housing shall have smooth, but not slippery floors; (b) the housing shall be provided with a comfortable, clean and dry laying or rest area of sufficient size, consisting of a solid construction which is not slatted. Ample dry bedding strewn with litter material shall be provided in the rest area. The litter shall comprise straw or other suitable natural material. The litter may be improved and enriched with any mineral product authorised pursuant to Article 24 as a fertiliser or soil conditioner for use in organic production; (c) there shall always be a bed made of straw or other suitable material large enough to ensure that all pigs in a pen can lie down at the same time in the most space-consuming way; (d) sows shall be kept in groups, except in the last stages of pregnancy and during the suckling period, during which time the sow must be able to move freely in her pen and her movement shall only be restricted for short periods; (e) without prejudice to any additional requirements for straw, a few days before expected farrowing, sows shall be provided with a quantity of straw or other suitable natural material sufficient to enable them to build nests; (f) exercise areas shall permit dunging and rooting by porcine animals. For the purposes of rooting, different substrates may be used. 1.9.4. For poultry 1.9.4.1. Origin of animals To prevent the use of intensive rearing methods, poultry shall either be reared until they reach a minimum age or else shall come from slow-growing poultry strains adapted to outdoor rearing. The competent authority shall define the criteria of slow-growing strains or draw up a list of those strains and provide this information to operators, other Member States and the Commission. Where slow-growing poultry strains are not used by the farmer, the minimum age at slaughter shall be as follows: (a) 81 days for chickens; (b) 150 days for capons; (c) 49 days for Peking ducks; (d) 70 days for female Muscovy ducks; (e) 84 days for male Muscovy ducks; (f) 92 days for Mallard ducks; (g) 94 days for guinea fowl; (h) 140 days for male turkeys and roasting geese; and (i) 100 days for female turkeys. 1.9.4.2. Nutrition With regard to nutrition, the following rules shall apply: (a) at least 30 % of the feed shall come from the farm itself or, if this is not feasible or such feed is not available, be produced in cooperation with other organic or in-conversion production units and feed operators using feed and feed material from the same region; (b) roughage, fresh or dried fodder, or silage shall be added to the daily ration; (c) where farmers are unable to obtain protein feed exclusively from organic production for poultry species, and the competent authority has confirmed that organic protein feed is not available in sufficient quantity, non-organic protein feed may be used until 31 December 2025, provided that the following conditions are fulfilled: (i) it is not available in organic form; (ii) it is produced or prepared without chemical solvents; (iii) its use is limited to the feeding of young poultry with specific protein compounds; and (iv) the maximum percentage authorised per period of 12 months for those animals does not exceed 5 %. The percentage of the dry matter of feed of agricultural origin shall be calculated. 1.9.4.3. Animal welfare Live plucking of poultry shall be prohibited. 1.9.4.4. Housing and husbandry practices With regard to housing and husbandry practices, the following rules shall apply: (a) at least one third of the floor area shall be solid, that is, not of slatted or of grid construction, and shall be covered with a litter material such as straw, wood shavings, sand or turf; (b) in poultry houses for laying hens, a sufficiently large part of the floor area available to the hens shall be available for the collection of bird droppings; (c) buildings shall be emptied of livestock between each batch of poultry that has been reared. The buildings and fittings shall be cleaned and disinfected during this time. In addition, when the rearing of each batch of poultry has been completed, runs shall be left empty during a period to be established by the Member States in order to allow vegetation to grow back. Those requirements shall not apply where poultry are not reared in batches, are not kept in runs and are free to roam throughout the day; (d) poultry shall have access to an open air area for at least one third of their life. However, laying hens and finisher poultry shall have access to an open air area for at least one third of their life, except where temporary restrictions have been imposed on the basis of Union legislation; (e) continuous daytime open air access shall be provided from as early an age as practically possible and whenever physiological and physical conditions allow, except where temporary restrictions have been imposed on the basis of Union legislation; (f) by way of derogation from point 1.6.5, in the case of breeding birds and pullets aged under 18 weeks, when the conditions specified in point 1.7.3 as regards restrictions and obligations related to the protection of human and animal health imposed on the basis of Union legislation are met and prevent breeding birds and pullets aged under 18 weeks from having access to open air areas, verandas shall be considered as open air areas and, in such cases, shall have a wire mesh barrier to keep other birds out; (g) open air areas for poultry shall permit fowl to have easy access to adequate numbers of drinking troughs; (h) open air areas for poultry shall be covered mainly with vegetation; (i) under conditions where feed availability from the range area is limited, for example, due to long term snow cover or arid weather conditions, supplementary feeding of roughage shall be included as part of poultry diets; (j) where poultry are kept indoors due to restrictions or obligations imposed on the basis of Union legislation, they shall have permanent access to sufficient quantities of roughage and suitable material in order to meet their ethological needs; (k) water fowl shall have access to a stream, pond, lake or a pool whenever the weather and hygienic conditions permit, in order to respect their species-specific needs and animal welfare requirements; when weather conditions do not permit such access, they shall have access to water which enables them to dip their head therein so as to clean plumage; (l) natural light may be supplemented by artificial means to provide a maximum of 16 hours light per day, with a continuous nocturnal rest period without artificial light of at least eight hours; (m) the total usable surface area for fattening poultry in poultry houses of any production unit shall not exceed 1 600 m2; (n) not more than 3 000 laying hens shall be allowed in a single compartment of a poultry house. 1.9.5. For rabbits 1.9.5.1. Nutrition With regard to nutrition, the following rules shall apply: (a) at least 70 % of the feed shall come from the farm itself or, if this is not feasible or such feed is not available, shall be produced in cooperation with other organic or in-conversion production units and feed operators using feed and feed material from the same region; (b) rabbits shall have access to pasturage for grazing whenever conditions allow; (c) rearing systems shall be based on maximum use of grazing pasturage by reference to the availability of pastures in the different periods of the year; (d) fibrous feed such as straw or hay shall be provided when grass is not sufficient. Forage shall comprise at least 60 % of the diet. 1.9.5.2. Housing and husbandry practices With regard to housing and husbandry practices, the following rules shall apply: (a) housing shall be provided with a comfortable, clean and dry laying or rest area of sufficient size, consisting of a solid construction which is not slatted. Ample dry bedding strewn with litter material shall be provided in the rest area. The litter shall comprise straw or other suitable natural material. The litter may be improved and enriched with any mineral product authorised pursuant to Article 24 as a fertiliser or soil conditioner for use in organic production; (b) rabbits shall be kept in groups. (c) rabbit farms shall use robust breeds adapted to outdoor conditions; (d) rabbits shall have access to: (i) covered shelter including dark hiding places; (ii) an outdoor run with vegetation, preferably pasture; (iii) a raised platform on which they can sit, either inside or out; (iv) nesting material for all nursing does. 1.9.6. For bees 1.9.6.1. Origin of animals For beekeeping, preference shall be given to the use of Apis mellifera and their local ecotypes. 1.9.6.2. Nutrition With regard to nutrition, the following rules shall apply: (a) at the end of the production season hives shall be left with sufficient reserves of honey and pollen for the bees to survive the winter; (b) bee colonies may only be fed where the survival of the colony is endangered due to climatic conditions. In such case, bee colonies shall be fed with organic honey, organic sugar syrups, or organic sugar. 1.9.6.3. Health care With regard to health care, the following rules shall apply: (a) for the purposes of protecting frames, hives and combs, in particular from pests, only rodenticides used in traps, and appropriate products and substances authorised pursuant to Articles 9 and 24 for use in organic production shall be permitted; (b) physical treatments for disinfection of apiaries such as steam or direct flame shall be permitted; (c) the practice of destroying the male brood shall only be permitted for the purpose of isolating the infestation of Varroa destructor; (d) if, despite all preventive measures, the colonies become sick or infested, they shall be treated immediately and, if necessary, may be placed in isolation apiaries; (e) formic acid, lactic acid, acetic acid and oxalic acid, as well as menthol, thymol, eucalyptol or camphor, may be used in cases of infestation with Varroa destructor; (f) if a treatment is applied with chemically synthesised allopathic products, including antibiotics, other than products and substances authorised pursuant to Articles 9 and 24 for use in organic production, for the duration of that treatment, the treated colonies shall be placed in isolation apiaries and all the wax shall be replaced with wax coming from organic beekeeping. Subsequently, the conversion period of 12 months laid down in point 1.2.2 shall apply to those colonies. 1.9.6.4. Animal welfare With regard to beekeeping, the following additional general rules shall apply: (a) the destruction of bees in the combs as a method associated with the harvesting of apiculture products shall be prohibited; (b) mutilation such as clipping the wings of queen bees shall be prohibited. 1.9.6.5. Housing and husbandry practices With regard to housing and husbandry practices, the following rules shall apply: (a) apiaries shall be placed in areas which ensure the availability of nectar and pollen sources consisting essentially of organically produced crops or, where appropriate, of spontaneous vegetation or non-organically managed forests or crops that are only treated with low environmental impact methods; (b) apiaries shall be kept at sufficient distance from sources that may lead to the contamination of apiculture products or to the poor health of the bees; (c) the siting of the apiaries shall be such that, within a radius of 3 km from the apiary site, nectar and pollen sources consist essentially of organically produced crops or spontaneous vegetation or crops treated with low environmental impact methods equivalent to those provided for in Articles 28 and 30 of Regulation (EU) No 1305/2013 which cannot affect the qualification of beekeeping production as being organic. That requirement does not apply where flowering is not taking place, or the bee colonies are dormant; (d) the hives and materials used in beekeeping shall be made basically of natural materials presenting no risk of contamination to the environment or the apiculture products; (e) the beeswax for new foundations shall come from organic production units; (f) only natural products such as propolis, wax and plant oils may be used in the hives; (g) synthetic chemical repellents shall not be used during honey extraction operations; (h) brood combs shall not be used for honey extraction; (i) beekeeping shall not be considered as organic when practiced in regions or areas designated by Member States as regions or areas where organic beekeeping is not practicable. Part III: Production rules for algae and aquaculture animals 1. General requirements 1.1. Operations shall be situated in locations that are not subject to contamination with products or substances not authorised for use in organic production, or with pollutants that would compromise the organic nature of the products. 1.2. Organic and non-organic production units shall be adequately separated in accordance with the minimum separation distances set by Member States, where applicable. Such separation measures shall be based on the natural situation, separate water distribution systems, distances, the tidal flow, and the upstream and the downstream location of the organic production unit. Algae and aquaculture production shall not be considered as organic when practiced at locations or in areas designated by Member State authorities as locations or areas which are unsuitable for such activities. 1.3. An environmental assessment that is appropriate to the production unit shall be required for any new operators applying for organic production and producing more than 20 tonnes of aquaculture products per year to ascertain the conditions of the production unit and its immediate environment and likely effects of its operation. The operator shall provide the environmental assessment to the control authority or control body. The content of the environmental assessment shall be based on Annex IV to Directive 2011/92/EU of the European Parliament and of the Council (4). If the production unit has already been subject to an equivalent assessment, that assessment may be used for this purpose. 1.4. Mangrove destruction shall not be permitted. 1.5. The operator shall provide a sustainable management plan proportionate to the production unit for aquaculture and algae harvesting. 1.6. The plan shall be updated annually and shall detail the environmental effects of the operation and the environmental monitoring to be undertaken, and shall list the measures to be taken to minimise negative impacts on the surrounding aquatic and terrestrial environments, including, where applicable, nutrient discharge into the environment per production cycle or per annum. The plan shall record the surveillance and repair of technical equipment. 1.7. Defensive and preventive measures taken against predators in accordance with Directive 92/43/EEC and national rules shall be recorded in the sustainable management plan. 1.8. Where applicable, coordination shall take place with the neighbouring operators in drawing up the management plan. 1.9. Aquaculture and algae business operators shall draw up as part of the sustainable management plan a waste reduction schedule to be put in place at the commencement of operations. Where possible, the use of residual heat shall be limited to energy from renewable sources. 1.10. Preparation of unprocessed products If preparation operations, other than processing, are carried out on algae or aquaculture animals, the general requirements laid down in points 1.2, 1.3, 1.4, 1.5 and 2.2.3 of Part IV shall apply mutatis mutandis to such operations. 2. Requirements for algae In addition to the general production rules laid down in Articles 9, 10, 11 and 15, and where relevant in Section 1 of this Part, the rules laid down in this Section shall apply to the organic collection and production of algae. Those rules shall apply mutatis mutandis to the production of phytoplankton. 2.1. Conversion 2.1.1. The conversion period for a production unit for algae collection shall be six months. 2.1.2. The conversion period for a production unit for algae cultivation shall be a period of six months or one full production cycle, whichever is the longer. 2.2. Production rules for algae 2.2.1. The collection of wild algae and parts thereof is considered as organic production provided that: (a) the growing areas are suitable from a health point of view and are of high ecological status as defined by Directive 2000/60/EC, or are of equivalent quality to: — the production zones classed as A and B in Regulation (EC) No 854/2004 of the European Parliament and of the Council (5), until 13 December 2019, or — the corresponding classification areas set out in the implementing acts adopted by the Commission in accordance with Article 18(8) of Regulation (EU) 2017/625, from 14 December 2019; (b) the collection does not affect significantly the stability of the natural ecosystem or the maintenance of the species in the collection area. 2.2.2. The cultivation of algae shall take place in areas with environmental and health characteristics at least equivalent to those outlined in point 2.2.1(a) in order to be considered organic. In addition the following production rules shall apply: (a) sustainable practices shall be used in all stages of production, from the collection of juvenile algae to harvesting; (b) to ensure that a wide gene-pool is maintained, the collection of juvenile algae in the wild shall take place on a regular basis so as to maintain and increase the diversity of indoor culture stock; (c) fertilisers shall not be used, except in indoor facilities, and only if they have been authorised pursuant to Article 24 for use in organic production for this purpose. 2.3. Algae cultivation 2.3.1. Algae culture at sea shall only utilise nutrients naturally occurring in the environment, or from organic aquaculture animal production, preferably located nearby as part of a polyculture system. 2.3.2. In facilities on land where external nutrient sources are used, the nutrient levels in the effluent water shall be verifiably the same, or lower, than the inflowing water. Only nutrients of plant or mineral origin authorised pursuant to Article 24 for use in organic production may be used. 2.3.3. Culture density or operational intensity shall be recorded and shall maintain the integrity of the aquatic environment by ensuring that the maximum quantity of algae which can be supported without negative effects on the environment is not exceeded. 2.3.4. Ropes and other equipment used for growing algae shall be re-used or recycled where possible. 2.4. Sustainable collection of wild algae 2.4.1. A once-off biomass estimate shall be undertaken at the outset of algae collection. 2.4.2. Documentary accounts shall be maintained in the unit or premises and shall enable the operator to identify and the control authority or control body to verify that the collectors have supplied only wild algae produced in accordance with this Regulation. 2.4.3. Collection shall be carried out in such a way that the amounts collected do not cause a significant impact on the state of the aquatic environment. Measures such as collection technique, minimum sizes, ages, reproductive cycles or size of remaining algae shall be taken to ensure that algae can regenerate and to ensure that by-catches are prevented. 2.4.4. If algae are collected from a shared or common collection area, documentary evidence produced by the relevant authority designated by the Member State concerned shall be available showing that the total collection complies with this Regulation. 3. Requirements for aquaculture animals In addition to the general production rules laid down in Article 9, 10, 11 and 15, and where relevant in Section 1 of this Part, the rules laid down in this Section shall apply to the organic production of species of fish, crustaceans, echinoderms and molluscs. Those rules also shall apply mutatis mutandis to the production of zooplankton, micro-crustaceans, rotifers, worms and other aquatic feed animals. 3.1. General requirements 3.1.1. Conversion The following conversion periods for aquaculture production units shall apply for the following types of aquaculture facilities including the existing aquaculture animals: (a) for facilities that cannot be drained, cleaned and disinfected, a conversion period of 24 months; (b) for facilities that have been drained, or fallowed, a conversion period of 12 months; (c) for facilities that have been drained, cleaned and disinfected, a conversion period of six months; (d) for open water facilities, including those producing bivalve molluscs, a conversion period of three months. 3.1.2. Origin of aquaculture animals 3.1.2.1. With regard to the origin of the aquaculture animals, the following rules shall apply: (a) organic aquaculture shall be based on the rearing of young stock originating from organic broodstock and from organic production units; (b) locally grown species shall be used, and breeding shall aim to produce strains which are better adapted to production conditions, ensuring good animal health and welfare and good utilisation of feed resources. Documentary evidence of their origin and treatment shall be provided for the competent authority, or, where appropriate, the control authority or control body; (c) species shall be chosen which are robust and can be produced without causing significant damage to wild stocks; (d) for breeding purposes, wild-caught or non-organic aquaculture animals may be brought into a holding only in duly justified cases where no organic breed is available or where new genetic stock for breeding purposes is brought into the production unit after an authorisation has been granted by the competent authority with a view to improving the suitability of genetic stock. Such animals shall be kept under organic management for at least three months before they may be used for breeding. For animals that are on the IUCN Red List of endangered species, the authorisation to use wild-caught specimens may only be granted in the context of conservation programmes recognised by the relevant public authority in charge of the conservation effort; (e) for on-growing purposes, the collection of wild aquaculture juveniles shall be specifically restricted to the following cases: (i) natural influx of fish or crustacean larvae and juveniles when filling ponds, containment systems and enclosures; (ii) restocking of wild fry or crustacean larvae of species that are not on the IUCN Red List of endangered species in extensive aquaculture farming inside wetlands, such as brackish water ponds, tidal areas and costal lagoons, provided that: — the restocking is in line with management measures approved by the relevant authorities to ensure the sustainable exploitation of the species concerned, and — the animals are fed exclusively with feed naturally available in the environment. By way of derogation from point (a), Member States may authorise the introduction for on-growing purposes on an organic production unit of a maximum of 50 % of non-organic juveniles of species that were not developed as organic in the Union by 1 January 2021, provided that at least the latter two thirds of the duration of the production cycle are managed under organic management. Such derogation may be granted for a maximum period of two years and shall not be renewable. For aquaculture holdings situated outside the Union, such derogation may only be granted by control authorities or control bodies that have been recognised in accordance with Article 46(1) for species that were not developed as organic in either the territory of the country in which the holding is located or the Union. Such derogation may be granted for a maximum period of two years and shall not be renewable. 3.1.2.2. With regard to breeding, the following rules shall apply: (a) hormones and hormone-derivates shall not be used; (b) the artificial production of monosex strains, except by hand-sorting, the induction of polyploidy, artificial hybridisation and cloning shall not be used; (c) appropriate strains shall be chosen. 3.1.3. Nutrition 3.1.3.1. With regard to feed for fish, crustaceans and echinoderms, the following rules shall apply: (a) animals shall be fed with feed that meets the animals’ nutritional requirements at the various stages of its development; (b) feeding regimes shall be designed with the following priorities: (i) animal health and welfare; (ii) high product quality, including the nutritional composition of the product, which shall ensure high quality of the final edible product; (iii) low environmental impact; (c) the plant fraction of feed shall be organic and the feed fraction derived from aquatic animals shall originate from organic aquaculture or from fisheries that have been certified as sustainable under a scheme recognised by the competent authority in line with the principles laid down in Regulation (EU) No 1380/2013; (d) non-organic feed materials of plant, animal, algal or yeast origin, feed materials of mineral or microbial origin, feed additives, and processing aids shall only be used if they have been authorised under this Regulation for use in organic production; (e) growth promoters and synthetic amino-acids shall not be used. 3.1.3.2. With regard to bivalve molluscs and other species which are not fed by man, but instead feed on natural plankton, the following rules shall apply: (a) such filter-feeding animals shall receive all their nutritional requirements from nature, except in the case of juveniles reared in hatcheries and nurseries; (b) the growing areas shall be suitable from a health point of view and shall either be of high ecological status as defined by Directive 2000/60/EC or of good environmental status as defined by Directive 2008/56/EC or of equivalent quality to: — the production zones classed as A in Regulation (EC) No 854/2004, until 13 December 2019, or — the corresponding classification areas set out in the implementing acts adopted by the Commission in accordance with Article 18(8) of Regulation (EU) 2017/625, from 14 December 2019. 3.1.3.3. Specific rules on feed for carnivorous aquaculture animals Feed for carnivorous aquaculture animals shall be sourced with the following priorities: (a) organic feed of aquaculture origin; (b) fish meal and fish oil from organic aquaculture trimmings sourced from fish, crustaceans or molluscs; (c) fish meal and fish oil and feed material of fish origin derived from trimmings of fish, crustaceans or molluscs already caught for human consumption in sustainable fisheries; (d) fish meal and fish oil and feed material of fish origin derived from whole fish, crustaceans or molluscs caught in sustainable fisheries and not used for human consumption; (e) organic feed materials of plant or animal origin; plant material shall not exceed 60 % of total ingredients. 3.1.3.4. Specific rules on feed for certain aquaculture animals In the grow-out phase, fish in inland waters, penaeid shrimps and freshwater prawns and tropical freshwater fish shall be fed as follows: (a) they shall be fed with feed naturally available in ponds and lakes; (b) where natural feed referred to in point (a) is not available in sufficient quantities, organic feed of plant origin, preferably grown on the farm itself, or algae may be used. Operators shall keep documentary evidence of the need to use additional feed; (c) where natural feed is supplemented in accordance with point (b): (i) the feed ration of penaeid shrimps and freshwater prawns (Macrobrachium spp.) may consist of a maximum of 25 % fishmeal and 10 % fish oil derived from sustainable fisheries; (ii) the feed ration of siamese catfish (Pangasius spp.) may consist of a maximum of 10 % fishmeal or fish oil derived from sustainable fisheries. 3.1.4. Health care 3.1.4.1. Disease prevention With regard to disease prevention, the following rules shall apply: (a) disease prevention shall be based on keeping the animals in optimal conditions by appropriate siting, taking into account, inter alia, the species’ requirements for good water quality, flow and exchange rate, the optimal design of the holdings, the application of good husbandry and management practices, including regular cleaning and disinfection of premises, high-quality feed, appropriate stocking density, and breed and strain selection; (b) immunological veterinary medicines may be used; (c) an animal health management plan shall detail biosecurity and disease prevention practices including a written agreement for health counselling, proportionate to the production unit, with qualified aquaculture animal health services who shall visit the farm at a frequency of not less than once per year or, in the case of bivalve shellfish, not less than once every two years; (d) holding systems, equipment and utensils shall be properly cleaned and disinfected; (e) bio-fouling organisms shall be removed only by physical means or by hand and where appropriate returned to the sea at a distance from the farm; (f) only substances for cleaning and disinfection of equipment and facilities authorised pursuant to Article 24 for use in organic production may be used; (g) with regard to fallowing, the following rules shall apply: (i) the competent authority, or, where appropriate, control authority or control body, shall determine whether fallowing is necessary and shall determine the appropriate duration which shall be applied and documented after each production cycle in open water containment systems at sea; (ii) it shall not be mandatory for bivalve mollusc cultivation; (iii) during fallowing the cage or other structure used for aquaculture animal production is emptied, disinfected and left empty before being used again; (h) where appropriate, uneaten fish-feed, faeces and dead animals shall be removed promptly to avoid any risk of significant environmental damage as regards water status quality, to minimise disease risks, and to avoid attracting insects or rodents; (i) ultraviolet light and ozone may only be used in hatcheries and nurseries; (j) for biological control of ectoparasites, preference shall be given to the use of cleaner fish and to the use of freshwater, marine water and sodium chloride solutions. 3.1.4.2. Veterinary treatments With regard to veterinary treatments, the following rules shall apply: (a) disease shall be treated immediately to avoid suffering to the animal. Chemically synthesised allopathic veterinary medicinal products, including antibiotics, may be used where necessary, under strict conditions and under the responsibility of a veterinarian, where the use of phytotherapeutic, homeopathic and other products is inappropriate. Where appropriate, restrictions with respect to courses of treatment and withdrawal periods shall be defined; (b) treatments related to the protection of human and animal health imposed on the basis of Union legislation shall be allowed; (c) when despite preventive measures to ensure animal health referred to in point 3.1.4.1 a health problem arises, veterinary treatments may be used in the following order of preference: (i) substances from plants, animals or minerals in a homoeopathic dilution; (ii) plants and their extracts not having anaesthetic effects; and (iii) substances such as trace elements, metals, natural immunostimulants or authorised probiotics; (d) the use of allopathic treatments shall be limited to two courses of treatment per year, with the exception of vaccinations and compulsory eradication schemes. However, in the cases of a production cycle of less than a year, a limit of one allopathic treatment shall apply. Where the indicated limits for allopathic treatments are exceeded, the aquaculture animals concerned shall not be marketed as organic products; (e) the use of parasite treatments, other than through compulsory control schemes operated by Member States, shall be limited to twice per year, or once per year where the production cycle is less than 18 months; (f) the withdrawal period for allopathic veterinary treatments and parasite treatments in accordance with point (d), including treatments under compulsory control and eradication schemes, shall be twice the withdrawal period referred to in Article 11 of Directive 2001/82/EC or, where this period is not specified, 48 hours; (g) any use of veterinary medicinal products shall be declared to the competent authority, or, where appropriate, to the control authority or control body, before the animals are marketed as organic products. Treated stock shall be clearly identifiable. 3.1.5. Housing and husbandry practices 3.1.5.1. Closed recirculation aquaculture animal production facilities shall be prohibited, with the exception of hatcheries and nurseries or facilities for the production of species used for organic feed organisms. 3.1.5.2. Artificial heating or cooling of water shall only be permitted in hatcheries and nurseries. Natural borehole water may be used to heat or cool water at all stages of production. 3.1.5.3. The husbandry environment of the aquaculture animals shall be designed in such a way that, in accordance with their species-specific needs, the aquaculture animals: (a) have sufficient space for their welfare and have the relevant stocking density laid down in the implementing acts referred to in Article 15(3); (b) are kept in water of good quality with, inter alia, an adequate flow and exchange rate, sufficient oxygen levels and keeping a low level of metabolites; (c) are kept in temperature and light conditions in accordance with the requirements of the species and having regard to the geographic location. In considering the effects of stocking density on the welfare of produced fish, the condition of the fish (such as fin damage, other injuries, growth rate, behaviour expressed and overall health) and the water quality shall be monitored and taken into account. In the case of freshwater fish, the bottom type shall be as close as possible to natural conditions. In the case of carp and similar species: — the bottom shall be natural earth, — organic and mineral fertilisation of the ponds and lakes shall be carried out only with fertilisers and soil conditioners that have been authorised pursuant to Article 24 for use in organic production, with a maximum application of 20 kg nitrogen/ha, — treatments involving synthetic chemicals for the control of hydrophytes and plant coverage present in production waters shall be prohibited. 3.1.5.4. The design and construction of aquatic containment systems shall provide flow rates and physiochemical parameters that safeguard the animals’ health and welfare, and that provide for their behavioural needs. The specific characteristics for production systems and containment systems for species or group of species laid down in the implementing acts referred to in Article 15(3) shall be complied with. 3.1.5.5. Rearing units on land shall meet the following conditions: (a) flow-through systems shall allow the monitoring and control of the flow rate and water quality of both in-flowing and out-flowing water; (b) at least 10 % of the perimeter (‘land-water interface’) area shall have natural vegetation. 3.1.5.6. Containment systems at sea shall meet the following conditions: (a) they shall be located where water flow, depth and water-body exchange rates are adequate to minimise the impact on the seabed and the surrounding water body; (b) they shall have suitable cage design, construction and maintenance with regard to their exposure to the operating environment. 3.1.5.7. Containment systems shall be designed, located and operated to minimise the risk of escape incidents. 3.1.5.8. If fish or crustaceans escape, appropriate action shall be taken to reduce the impact on the local ecosystem, including recapture where appropriate. Records shall be kept. 3.1.5.9. For aquaculture animal production in fishponds, tanks or raceways, farms shall be equipped with either natural-filter beds, settlement ponds, biological filters or mechanical filters to collect waste nutrients or use algae or animals (bivalves) which contribute to improving the quality of the effluent. Effluent monitoring shall be carried out at regular intervals where appropriate. 3.1.6. Animal welfare 3.1.6.1. All persons involved in keeping aquaculture animals shall possess the necessary basic knowledge and skills as regards the health and the welfare needs of those animals. 3.1.6.2. The handling of aquaculture animals shall be minimised, and shall be undertaken with the greatest care. Proper equipment and protocols shall be used to avoid stress and physical damage associated with handling procedures. Broodstock shall be handled in such a manner as to minimise physical damage and stress, and shall be handled under anaesthesia where appropriate. Grading operations shall be kept to a minimum and shall only be used where required to ensure fish welfare. 3.1.6.3. The following restrictions shall apply to the use of artificial light: (a) for prolonging natural day length, it shall not exceed a maximum that respects the ethological needs, geographical conditions and general health of the animals; this maximum shall not exceed 14 hours per day, except where necessary for reproductive purposes; (b) abrupt changes in light intensity shall be avoided at the changeover time through the use of dimmable lights or background lighting. 3.1.6.4. Aeration shall be permitted to ensure animal welfare and health. Mechanical aerators shall be preferably powered by renewable energy sources. 3.1.6.5. Oxygen may only be used for uses linked to animal health and welfare requirements and for critical periods of production or transport, and only in the following cases: (a) exceptional cases of a change in temperature, a drop in atmospheric pressure or accidental water pollution; (b) occasional stock management procedures, such as sampling and sorting; (c) in order to assure the survival of the farm stock. 3.1.6.6. Appropriate measures shall be taken to keep the duration of the transport of aquaculture animals to a minimum. 3.1.6.7. Any suffering shall be kept to a minimum during the entire life of the animal, including at the time of slaughter. 3.1.6.8. Eyestalk ablation, including all similar practices such as ligation, incision and pinching, is prohibited. 3.1.6.9. Slaughter techniques shall render fish immediately unconscious and insensible to pain. Handling prior to slaughter shall be performed in a way that avoids injuries while keeping suffering and stress at a minimum. Differences in harvesting sizes, species, and production sites shall be taken into account when considering optimal slaughtering methods. 3.2. Detailed rules for molluscs 3.2.1. Origin of seed With regard to the origin of seed, the following rules shall apply: (a) wild seed from outside the boundaries of the production unit may be used in the case of bivalve shellfish, provided that there is no significant damage to the environment, provided that it is permitted by local legislation and provided that the wild seed comes from: (i) settlement beds which are unlikely to survive winter weather or are surplus to requirements; or (ii) natural settlement of shellfish seed on collectors; (b) for the cupped oyster (Crassostrea gigas), preference shall be given to stock which is selectively bred to reduce spawning in the wild; (c) records shall be kept of how, where and when wild seed was collected to allow traceability back to the collection area; (d) wild seed may only be collected after the competent authority has granted authorisation to do so. 3.2.2. Housing and husbandry practices With regard to housing and husbandry practices, the following rules shall apply: (a) production may be carried out in the same area of water as organic finfish and algae production, in a polyculture system that shall be documented in the sustainable management plan. Bivalve molluscs may also be grown together with gastropod molluscs, such as periwinkles, in polyculture; (b) organic bivalve mollusc production shall take place within areas delimited by posts, floats or other clear markers and shall, where appropriate, be restrained by net bags, cages or other man made means; (c) organic shellfish farms shall minimise risks to species of conservation interest. If predator nets are used, their design shall not permit diving birds to be harmed. 3.2.3. Cultivation With regard to cultivation, the following rules shall apply: (a) cultivation on mussel ropes and other methods listed in the implementing acts referred to in Article 15(3) may be used in organic production; (b) the bottom cultivation of molluscs is only permitted where no significant environmental impact is caused at the collection and growing sites. A survey and report supporting the evidence of minimal environmental impact shall be added as a separate chapter to the sustainable management plan, and shall be provided by the operator to the competent authority, or, where appropriate, to the control authority or control body, before starting operations. 3.2.4. Management With regard to management, the following rules shall apply: (a) production shall use a stocking density not in excess of that used for non-organic molluscs in the locality. Sorting, thinning and stocking density adjustments shall be made according to the biomass and to ensure animal welfare and high product quality; (b) biofouling organisms shall be removed by physical means or by hand and where appropriate returned to the sea away from mollusc farms. Molluscs may be treated once during the production cycle with a lime solution to control competing fouling organisms. 3.2.5. Specific cultivation rules for oysters Cultivation in bags on trestles shall be permitted. Those or other structures in which the oysters are contained shall be set out so as to avoid the formation of a total barrier along the shoreline. Stock shall be positioned carefully on the beds in relation to tidal flow to optimise production. Production shall meet the requirements set out in the implementing acts referred to in Article 15(3). Part IV: Processed food production rules In addition to the general production rules laid down in Articles 9, 11 and 16, the rules laid down in this Part shall apply to the organic production of processed food. 1. General requirements for the production of processed food 1.1. Food additives, processing aids and other substances and ingredients used for processing food and any processing practice applied, such as smoking, shall comply with the principles of good manufacturing practice (6). 1.2. Operators producing processed food shall establish and update appropriate procedures based on a systematic identification of critical processing steps. 1.3. The application of the procedures referred to in point 1.2 shall ensure that the produced processed products comply with this Regulation at all times. 1.4. Operators shall comply with and implement the procedures referred to in point 1.2, and, without prejudice to Article 28, shall in particular,: (a) take precautionary measures; (b) implement suitable cleaning measures, monitor their effectiveness and keep records of those operations; (c) guarantee that non-organic products are not placed on the market with an indication referring to organic production. 1.5. The preparation of processed organic, in-conversion and non-organic products shall be kept separate from each other in time or space. Where organic, in-conversion and non-organic products, in any combination, are prepared or stored in the preparation unit concerned, the operator shall: (a) inform the competent authority, or, where appropriate, the control authority or control body, accordingly; (b) carry out the operations continuously until the production run has been completed, separately in place or time from similar operations performed on any other kind of product (organic, in-conversion or non-organic); (c) store organic, in-conversion and non-organic products, before and after the operations, separate by place or time from each other; (d) keep available an updated register of all operations and quantities processed; (e) take the necessary measures to ensure identification of lots and to avoid mixtures or exchanges between organic, in-conversion and non-organic products; (f) carry out operations on organic or in-conversion products only after suitable cleaning of the production equipment. 1.6. Products, substances and techniques that reconstitute properties that are lost in the processing and storage of organic food, that correct the results of negligence in the processing of organic food, or that otherwise may be misleading as to the true nature of products intended to be marketed as organic food, shall not be used. 2. Detailed requirements for the production of processed food 2.1. The following conditions shall apply to the composition of processed organic food: (a) the product shall be produced mainly from agricultural ingredients or products intended for use as food listed in Annex I; for the purpose of determining whether a product has been produced mainly from those products, added water and salt shall not be taken into account; (b) an organic ingredient shall not be present together with the same ingredient in non-organic form; (c) an in-conversion ingredient shall not be present together with the same ingredient in organic or non-organic form. 2.2. Use of certain products and substances in processing of food 2.2.1. Only food additives, processing aids and non-organic agricultural ingredients authorised pursuant to Article 24 or Article 25 for use in organic production, and the products and substances referred to in point 2.2.2 may be used in the processing of food, with the exception of products and substances of the wine sector, for which point 2 of Part VI shall apply, and with the exception of yeast, for which point 1.3 of Part VII shall apply. 2.2.2. In the processing of food, the following products and substances may be used: (a) preparations of micro-organisms and food enzymes normally used in food processing, provided that food enzymes to be used as food additives have been authorised pursuant to Article 24 for use in organic production; (b) substances and products defined in points (c) and (d)(i) of Article 3(2) of Regulation (EC) No 1334/2008 that have been labelled as natural flavouring substances or natural flavouring preparations in accordance with Article 16(2), (3) and (4) of that Regulation; (c) colours for stamping meat and eggshells in accordance with Article 17 of Regulation (EC) No 1333/2008; (d) natural colours and natural coating substances for the traditional decorative colouring of the shell of boiled eggs produced with the intention of placing them on the market at a given period of the year; (e) drinking water and organic or non-organic salt (with sodium chloride or potassium chloride as basic components) generally used in food processing; (f) minerals (trace elements included), vitamins, amino acids and micronutrients, provided that: (i) their use in food for normal consumption is ‘directly legally required’, in the meaning of being directly required by provisions of Union law or provisions of national law compatible with Union law, with the consequence that the food cannot be placed at all on the market as food for normal consumption if those minerals, vitamins, amino acids or micronutrients are not added; or (ii) as regards food placed on the market as having particular characteristics or effects in relation to health or nutrition or in relation to needs of specific groups of consumers: — in products referred to in points (a) and (b) of Article 1(1) of Regulation (EU) No 609/2013 of the European Parliament and of the Council (7) their use is authorised by that Regulation and acts adopted on the basis of Article 11(1) of that Regulation for the products concerned, or — in products regulated by Commission Directive 2006/125/EC (8), their use is authorised by that Directive. 2.2.3. Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in processing shall be used for that purpose. 2.2.4. For the purpose of the calculation referred to in Article 30(5), the following rules shall apply: (a) certain food additives authorised pursuant to Article 24 for use in organic production shall be calculated as agricultural ingredients; (b) preparations and substances referred to in points (a), (c), (d), (e) and (f) of point 2.2.2 shall not be calculated as agricultural ingredients; (c) yeast and yeast products shall be calculated as agricultural ingredients. Part V: Processed feed production rules In addition to the general production rules laid down in Articles 9, 11 and 17, the rules laid down in this Part shall apply to the organic production of processed feed. 1. General requirements for the production of processed feed 1.1. Feed additives, processing aids and other substances and ingredients used for processing feed, and any processing practice used, such as smoking, shall comply with the principles of good manufacturing practice. 1.2. Operators that produce processed feed shall establish and update appropriate procedures based on a systematic identification of the critical processing steps. 1.3. The application of the procedures referred to in point 1.2 shall ensure that the produced processed products comply with this Regulation at all times. 1.4. Operators shall comply with and implement the procedures referred to in point 1.2, and, without prejudice to Article 28, shall in particular: (a) take precautionary measures; (b) implement suitable cleaning measures, monitor their effectiveness and keep records of those operations; (c) guarantee that non-organic products are not placed on the market with an indication referring to organic production. 1.5. The preparation of processed organic, in-conversion and non-organic products shall be kept separate from each other in time or space. Where organic, in-conversion and non-organic products, in any combination, are prepared or stored in the preparation unit concerned, the operator shall: (a) inform the control authority or control body accordingly; (b) carry out the operations continuously until the production run has been completed, separately in place or time from similar operations performed on any other kind of product (organic, in-conversion or non-organic); (c) store organic, in-conversion and non-organic products, before and after the operations, separate by place or time from each other; (d) keep available an updated register of all operations and quantities processed; (e) take the necessary measures to ensure identification of lots and to avoid mixtures or exchanges between organic, in-conversion and non-organic products; (f) carry out operations on organic or in-conversion products only after suitable cleaning of the production equipment. 2. Detailed requirements for the production of processed feed 2.1. Organic feed materials, or in-conversion feed materials, shall not enter simultaneously with the same feed materials produced by non-organic means into the composition of the organic feed product. 2.2. Any feed materials used or processed in organic production shall not have been processed with the aid of chemically synthesised solvents. 2.3. Only non-organic feed material of plant, algal, animal or yeast origin, feed material of mineral origin, and feed additives and processing aids authorised pursuant to Article 24 for use in organic production may be used in the processing of feed. 2.4. Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in processing shall be used for that purpose. Part VI: Wine 1. Scope 1.1. In addition to the general production rules laid down in Articles 9, 10, 11, 16 and 18, the rules laid down in this Part shall apply to the organic production of the products of the wine sector as referred to in point (l) of Article 1(2) of Regulation (EU) No 1308/2013. 1.2. Commission Regulations (EC) No 606/2009 (9) and (EC) No 607/2009 (10) shall apply, save as explicitly provided otherwise in this Part. 2. Use of certain products and substances 2.1. Products of the wine sector shall be produced from organic raw material. 2.2. Only products and substances authorised pursuant to Article 24 for use in organic production may be used for the making of products of the wine sector, including during the oenological practices, processes and treatments, subject to the conditions and restrictions laid down in Regulation (EU) No 1308/2013 and Regulation (EC) No 606/2009, and in particular in Annex I A to the latter Regulation. 3. Oenological practices and restrictions 3.1. Without prejudice to Sections 1 and 2 of this Part and to specific prohibitions and restrictions provided for in points 3.2, 3.3 and 3.4, only oenological practices, processes and treatments, including the restrictions provided for in Article 80 and Article 83(2) of Regulation (EU) No 1308/2013, in Article 3, Articles 5 to 9 and Articles 11 to 14 of Regulation (EC) No 606/2009, and in the Annexes to those Regulations used before 1 August 2010 shall be permitted. 3.2. The use of the following oenological practices, processes and treatments shall be prohibited: (a) partial concentration through cooling in accordance with point (c) of Section B.1 of Part I of Annex VIII to Regulation (EU) No 1308/2013; (b) elimination of sulphur dioxide by physical processes in accordance with point 8 of Annex I A to Regulation (EC) No 606/2009; (c) electrodialysis treatment to ensure the tartaric stabilisation of the wine in accordance with point 36 of Annex I A to Regulation (EC) No 606/2009; (d) partial dealcoholisation of wine in accordance with point 40 of Annex I A to Regulation (EC) No 606/2009; (e) treatment with cation exchangers to ensure the tartaric stabilisation of the wine in accordance with point 43 of Annex I A to Regulation (EC) No 606/2009. 3.3. The use of the following oenological practices, processes and treatments is permitted under the following conditions: (a) heat treatments in accordance with point 2 of Annex I A to Regulation (EC) No 606/2009, provided that the temperature does not exceed 75 °C; (b) centrifuging and filtration with or without an inert filtering agent in accordance with point 3 of Annex I A to Regulation (EC) No 606/2009, provided that the size of the pores is not smaller than 0,2 micrometres. 3.4. Any amendment introduced after 1 August 2010 concerning the oenological practices, processes and treatments provided for in Regulation (EC) No 1234/2007 or Regulation (EC) No 606/2009 may apply to the organic production of wine only after those measures have been included as permitted in this Section and, if required, after an evaluation in accordance with Article 24 of this Regulation. Part VII: Yeast used as food or feed In addition to the general production rules laid down in Articles 9, 11, 16, 17 and 19, the rules laid down in this Part shall apply to the organic production of yeast used as food or feed. 1. General requirements 1.1. For the production of organic yeast, only organically produced substrates shall be used. However, until 31 December 2023, the addition of up to 5 % non-organic yeast extract or autolysate to the substrate (calculated in weight of dry matter) is allowed for the production of organic yeast where operators are unable to obtain yeast extract or autolysate from organic production. 1.2. Organic yeast shall not be present in organic food or feed together with non-organic yeast. 1.3. The following products and substances may be used in the production, confection and formulation of organic yeast: (a) processing aids authorised pursuant to Article 24 for use in organic production; (b) products and substances referred to in points (a), (b) and (e) of point 2.2.2 of Part IV. 1.4. Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in processing shall be used for that purpose. (1) Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1). (2) Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, p. 1). (3) Council Directive 2008/119/EC of 18 December 2008 laying down minimum standards for the protection of calves (OJ L 10, 15.1.2009, p. 7). (4) Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, p. 1). (5) Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (OJ L 139, 30.4.2004, p. 206). (6) Good manufacturing practices (GMPs) as defined in Article 3(a) of Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food (OJ L 384, 29.12.2006, p. 75). (7) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35). (8) Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p. 16). (9) Commission Regulation (EC) No 606/2009 of 10 July 2009 laying down certain detailed rules for implementing Council Regulation (EC) No 479/2008 as regards the categories of grapevine products, oenological practices and the applicable restrictions (OJ L 193, 24.7.2009, p. 1). (10) Commission Regulation (EC) No 607/2009 of 14 July 2009 laying down certain detailed rules for the implementation of Council Regulation (EC) No 479/2008 as regards protected designations of origin and geographical indications, traditional terms, labelling and presentation of certain wine sector products (OJ L 193, 24.7.2009, p. 60). ANNEX III COLLECTION, PACKAGING, TRANSPORT AND STORAGE OF PRODUCTS 1. Collection of products and transport to preparation units Operators may carry out the simultaneous collection of organic, in-conversion and non-organic products only where appropriate measures have been taken to prevent any possible mixture or exchange between organic, in-conversion and non-organic products and to ensure the identification of the organic and in-conversion products. The operator shall keep the information relating to collection days, hours, the circuit and date and time of the reception of the products available to the control authority or control body. 2. Packaging and transport of products to other operators or units 2.1. Operators shall ensure that organic and in-conversion products are transported to other operators or units, including wholesalers and retailers, only in appropriate packaging, containers or vehicles closed in such a manner that substitution of the content cannot be achieved without manipulation or damage of the seal and provided with a label stating, without prejudice to any other indications required by Union law: (a) the name and address of the operator and, where different, of the owner or seller of the product; (b) the name of the product or a description of the compound feedstuff accompanied by a reference to organic production; (c) the name or the code number of the control authority or control body to which the operator is subject; and (d) where relevant, the lot identification mark in accordance with a marking system either approved at national level or agreed with the control authority or control body and which permits the linking of the lot with the records referred to in Article 34(5). The information referred to in points (a) to (d) may also be presented on an accompanying document, if such a document can be undeniably linked with the packaging, container or vehicular transport of the product. This accompanying document shall include information on the supplier or the transporter. 2.2. The closing of packaging, containers or vehicles shall not be required where: (a) the transport takes place directly between two operators, both of which are subject to the organic control system; (b) the transport includes only organic or only in-conversion products; (c) the products are accompanied by a document giving the information required under point 2.1; and (d) both the expediting and the receiving operators keep documentary records of such transport operations available for the control authority or control body. 3. Special rules for transporting feed to other production or preparation units or storage premises When transporting feed to other production or preparation units or storage premises, operators shall ensure that the following conditions are met: (a) during transport, organically produced feed, in-conversion feed, and non-organic feed are effectively physically separated; (b) vehicles or containers which have transported non-organic products are only used to transport organic or in-conversion products if: (i) suitable cleaning measures, the effectiveness of which has been checked, have been carried out before commencing the transport of organic or in-conversion products and the operators keep records of those operations; (ii) all appropriate measures are implemented, depending on the risks evaluated in accordance with control arrangements, and where necessary, operators guarantee that non-organic products cannot be placed on the market with an indication referring to organic production; (iii) the operator keeps documentary records of such transport operations available for the control authority or control body; (c) the transport of finished organic or in-conversion feed is separated physically or in time from the transport of other finished products; (d) during transport, the quantity of products at the start and each individual quantity delivered in the course of a delivery round is recorded. 4. Transport of live fish 4.1. Live fish shall be transported in suitable tanks with clean water which meets their physiological needs in terms of temperature and dissolved oxygen. 4.2. Before transport of organic fish and fish products, tanks shall be thoroughly cleaned, disinfected and rinsed. 4.3. Precautions shall be taken to reduce stress. During transport, the density shall not reach a level which is detrimental to the species. 4.4. Records shall be kept for operations referred to in points 4.1, 4.2 and 4.3. 5. Reception of products from other operators of units On receipt of an organic or in-conversion product, the operator shall check the closing of the packaging, container or vehicle where it is required and the presence of the indications provided for in Section 2. The operator shall cross-check the information on the label referred to in Section 2 with the information on the accompanying documents. The result of those verifications shall be explicitly mentioned in the records referred to in Article 34(5). 6. Special rules for the reception of products from a third country Where organic or in-conversion products are imported from a third country, they shall be transported in appropriate packaging or containers, closed in a manner that prevents the substitution of the content and bearing the identification of the exporter and any other marks and numbers that serve to identify the lot, and shall be accompanied by the certificate of control for import from third countries where appropriate. On receipt of an organic or in-conversion product imported from a third country, the natural or legal person to whom the imported consignment is delivered and who receives it for further preparation or marketing shall check the closing of the packaging or container and, in the case of products imported in accordance with point (b)(iii) of Article 45(1), shall check that the certificate of inspection referred to in that Article covers the type of product contained in the consignment. The result of this verification shall be explicitly mentioned in the records referred to in Article 34(5). 7. Storage of products 7.1. Areas for the storage of products shall be managed in such a way as to ensure identification of lots and to avoid any mixing or contamination with products or substances not in compliance with the organic production rules. Organic and in-conversion products shall be clearly identifiable at all times. 7.2. No input products or substances other than those authorised pursuant to Articles 9 and 24 for use in organic production shall be stored in organic or in-conversion plant and livestock production units. 7.3. Allopathic veterinary medicinal products, including antibiotics, may be stored in agricultural and aquaculture holdings provided that they have been prescribed by a veterinarian in connection with the treatment referred to in points 1.5.2.2 of Part II and 3.1.4.2(a) of Part III of Annex II, that they are stored in a supervised location and that they are entered in the records referred to in Article 34(5). 7.4. Where operators handle organic, or in-conversion or non-organic products in any combination and the organic or in-conversion products are stored in storage facilities in which also other agricultural products or foodstuffs are stored: (a) the organic or in-conversion products shall be kept separate from the other agricultural products or foodstuffs; (b) every measure shall be taken to ensure identification of consignments and to avoid mixtures or exchanges between organic, in-conversion and non-organic products; (c) suitable cleaning measures, the effectiveness of which has been checked, shall have been carried out before the storage of organic or in-conversion products and the operators shall keep records of those operations. 7.5. Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in organic production shall be used in storage facilities for that purpose. ANNEX IV TERMS REFERRED TO IN ARTICLE 30 BG : биологичен. ES : ecológico, biológico, orgánico. CS : ekologické, biologické. DA : økologisk. DE : ökologisch, biologisch. ET : mahe, ökoloogiline. EL : βιολογικό. EN : organic. FR : biologique. GA : orgánach. HR : ekološki. IT : biologico. LV : bioloģisks, ekoloģisks. LT : ekologiškas. LU : biologesch, ökologesch. HU : ökológiai. MT : organiku. NL : biologisch. PL : ekologiczne. PT : biológico. RO : ecologic. SK : ekologické, biologické. SL : ekološki. FI : luonnonmukainen. SV : ekologisk. ANNEX V ORGANIC PRODUCTION LOGO OF THE EUROPEAN UNION AND CODE NUMBERS 1. Logo 1.1. The organic production logo of the European Union shall comply with the model below: 1.2. The reference colour in Pantone is Green Pantone No 376 and Green (50 % Cyan + 100 % Yellow), when a four-colour process is used. 1.3. The organic production logo of the European Union may also be used in black and white as shown, only where it is not practicable to apply it in colour: 1.4. If the background colour of the packaging or label is dark, the symbols may be used in negative format, using the background colour of the packaging or label. 1.5. If a logo is used in colour on a coloured background which makes it difficult to see, a delimiting outer line around the logo can be used to improve contrast with the background colours. 1.6. Where there are indications in a single colour on the packaging, the organic production logo of the European Union may be used in the same colour. 1.7. The organic production logo of the European Union shall have a height of at least 9 mm and a width of at least 13,5 mm; the proportion ratio height/width shall always be 1:1,5. Exceptionally, the minimum size may be reduced to a height of 6 mm for very small packages. 1.8. The organic production logo of the European Union may be associated with graphical or textual elements referring to organic production under the condition that they do not modify or change the nature of the organic production logo of the European Union, nor any of the indications defined in accordance with Article 32. When associated to national or private logos using a green colour different from the reference colour provided for in point 1.2, the organic production logo of the European Union may be used in that non-reference colour. 2. Code numbers The general format of the code numbers shall be as follows: AB-CDE-999 where: (a) ‘AB’ is the ISO code for the country where the controls take place; (b) ‘CDE’ is a term, indicated in three letters to be decided by the Commission or each Member State, like ‘bio’ or ‘öko’ or ‘org’ or ‘eko’ establishing a link with organic production; and (c) ‘999’ is the reference number, indicated in maximum three digits, to be assigned by: (i) each Member State’s competent authority to the control authorities or control bodies to which it has delegated control tasks; (ii) the Commission, to: — the control authorities and control bodies recognised by the Commission pursuant to Article 46, — to the competent authorities of third countries recognised by the Commission pursuant to Article 48. ANNEX VI MODEL OF CERTIFICATE Certificate pursuant to Article 35(1) of Regulation (EU) 2018/848 on organic production and labelling of organic products Text of image 1. Document number: 2. (tick one box as appropriate) Operator Group of operators – see annex 3. Name and address of operator or group of operators: 4. Activit(y)(ies) of the operator or group of operators (choose as appropriate): Agricultural production Preparation Distribution Storing Import Export Placing on the market 5. Name, address and code number of control authority or control body of the operator or group of operators: 6. Categor(y)(ies) of products as referred to in Article 35(7) of Regulation (EU) 2018/848 and production methods (choose as appropriate): unprocessed plants and plant products, including seeds and other plant reproductive material Production method: organic production excluding during the conversion period production during the conversion period organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market) Certificate validity period from … to … livestock and unprocessed livestock products Production method: organic production excluding during the conversion period production during the conversion period organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market) Certificate validity period from … to … algae and unprocessed aquaculture products Production method: organic production excluding during the conversion period production during the conversion period organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market) Certificate validity period from … to … Text of image processed agricultural products, including aquaculture products, for use as food Production method: production of organic products production of in-conversion products organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market) Certificate validity period from … to … feed Production method: production of organic products production of in-conversion products organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market) Certificate validity period from … to … wine Production method: production of organic products production of in-conversion products organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market) Certificate validity period from … to … other products listed in Annex I to Regulation (EU) 2018/848 or not covered by previous categories (please specify): Production method: production of organic products production of in-conversion products organic production with non-organic production (pursuant to Article 9(7) of Regulation (EU) 2018/848 or in the case of preparation, distribution, storing, import, export, placing on the market) Certificate validity period from … to … This document has been issued in accordance with Regulation (EU) 2018/848 to certify that the operator or group of operators (choose as appropriate) meets the requirements of that Regulation. Date, place: Signature on behalf of the issuing control authority or control body: Annex – List of members of group of operators as defined in Article 36 of Regulation (EU) 2018/848 Name of member Address

EU rules on producing and labelling organic products (from 2022) EU rules on producing and labelling organic products (from 2022) SUMMARY OF: Regulation (EU) 2018/848 — rules on organic production and labelling of organic products WHAT IS THE AIM OF THE REGULATION? It aims to revise and strengthen the European Union’s (EU) rules concerning organic production and the labelling of organic products in relation to: the control system the trade regime production rules. In this way, it seeks to: create a level playing field for operators; harmonise and simplify rules; improve consumer confidence in organic products and in the EU’s organic logo. KEY POINTS The regulation broadens the scope of the existing legislation on the production and labelling of organic products (Regulation (EC) No 834/2007) to cover products closely linked to agriculture such as cork, salt, essential oils, cotton or wool. It harmonises the rules applicable to organic operators in the EU Member States and non-EU countries through the introduction of the compliance system. It simplifies access to the scheme for small operators. It reviews the livestock organic production rules and introduces rules for new species such as rabbits. Principles Organic production should: respect natural systems and cycles and maintain and improve the state of soil, water and air, plant and animal health, and the balance among them; preserve the elements of natural landscapes; use energy and natural resources responsibly; produce a wide variety of high-quality products to meet consumer demand; ensure the integrity of organic production at all stages of the production, processing and distribution processes of food and animal feed; exclude the use of genetically modified organisms (GMOs)* and products produced from or by GMOs*, other than veterinary drugs; restrict the use of external inputs; design and manage biological processes using methods based on risk assessment and the use of precautionary and preventive measures; exclude animal cloning; ensure a high level of animal welfare. Requirements Among other things, organic farming must: maintain and enhance soil life and its natural fertility, stability, water retention capacity and biodiversity; use seeds and animals with a high degree of genetic diversity, disease resistance and longevity; choose plant varieties — taking into account the characteristics of specific organic production systems — focusing on agronomic performance and disease resistance; choose animal breeds to take into account their genetic value, longevity, vitality and resistance to diseases or health problems; practise site-adapted and land-related breeding. Production To avoid adverse effects on the environment and on animal and plant health, producers must: take preventive measures at each stage of production, preparation and distribution to preserve biodiversity and soil qualityprevent the occurrence of pests and diseasescontrol these pests and diseases; take proportionate and precautionary measures to avoid contamination with products or substances not authorised for use in organic production. Conversion period When a farm wishes to produce organic products, it must go through a conversion period during which it must be managed according to organic production rules, although its products at this stage are not considered to be organic. It can only place its products on the market as organic products once this conversion period has elapsed and has been checked. Following the conversion period, any EU-based farm wishing to move to organic production must be managed fully in line with organic production requirements. The regulation also allows parallel farms (i.e. non-organic, in-conversion and organic), provided that these activities are clearly and genuinely separated. Certification Operators (i.e. producers, processors and distributors) must notify the competent authorities of their activities to become officially certified that they comply with the organic production and labelling rules. The regulation introduces a new system of group certification* for small farmers, making it easier for them to switch to organic farming. Official controls and labelling The control system is strengthened by means of stricter precautionary measures and more robust risk-based controls of the supply chain. In principle, there are on-the-spot checks on operators once a year. However, where previous controls have not revealed any instance of non-compliance over the previous 3 years, the period between physical on-the-spot inspections may be extended to up to 2 years. If a control body suspects an operator of trying to place a non-authorised product on the market as ‘organic’, it must formally investigate and temporarily ban the placing on the market of that product pending the investigation’s outcome. In the event of serious or repeated infringements, operators may be prohibited from selling products described as organic for a given period or may have their certificate withdrawn. Specific controls on organic farming will be complemented by the EU’s general rules on official controls along the agri-food chain. Imports A product may be imported from a non-EU country to be sold in the EU as an organic product if certain conditions are met. It must: comply with production and control rules of the non-EU country that are recognised under an international agreement as equivalent to those in the EU; have a certificate issued by the relevant control authorities or control bodies in non-EU countries confirming that the product complies with EU standards. Implementing acts Commission Implementing Regulation (EU) 2020/464 lays down certain rules for applying Regulation (EU) 2018/848 as regards: the documents needed for the retroactive recognition of periods for the purpose of conversion; the production of organic products; the information Member States need to provide to the European Commission. Commission Implementing Regulation (EU) 2021/279 lays down rules for: official investigations in cases of suspicion of non-compliance; the size of operator groups and the documentation of their system of internal controls; minimum control requirements; the national catalogue of measures in cases of non-compliance; the exchange of information between the Member States and the Commission. Delegated acts The Commission has adopted several delegated acts amending the annexes to Regulation (EU) 2018/848. Delegated Regulation (EU) 2020/427 amends Annex II to Regulation (EU) 2018/848 as regards certain detailed production rules for organic products. This was amended in turn by Delegated Regulation (EU) 2021/269. Delegated Regulation (EU) 2020/1794 amends Part I of Annex II to Regulation (EU) 2018/848 as regards the use of in-conversion and non-organic plant reproductive material. Delegated Regulation (EU) 2021/642 amends Annex III to Regulation (EU) 2018/848 as regards certain information to be provided on the labelling of organic products. Delegated Regulation (EU) 2021/715 amends Regulation (EU) 2018/848 as regards the requirements for groups of operators. Delegated Regulation (EU) 2021/716 amends Annex II to Regulation (EU) 2018/848 as regards organic production rules on sprouted seeds and chicory heads, on feed for certain aquaculture animals and on aquaculture parasite treatments. In addition, two delegated regulations supplement the rules in Regulation (EU) 2018/848. Delegated Regulation (EU) 2020/2146 supplements Regulation (EU) 2018/848 as regards exceptional production rules in organic production. Delegated Regulation (EU) 2021/771 supplements Regulation (EU) 2018/848 by laying down specific criteria and conditions for the checks of documentary accounts in the framework of official controls in organic production and the official controls of groups of operators. Repeal Regulation (EU) 2018/848 repeals and replaces Regulation (EC) No 834/2007 (see summary) as of 1 January 2022. FROM WHEN DOES THE REGULATION APPLY? It applies from 1 January 2022 (its application date having been postponed by 1 year by Regulation (EU) 2020/1693 in view of the COVID-19 pandemic and the related public health crisis). BACKGROUND For more information, see: Legislation for the organics sector (European Commission). KEY TERMS Genetically modified organisms (GMOs): plants or animals bred by modifying their cellular and genetic make-up, in order to, for example, have a higher yield or resist disease. Products produced from or by GMOs: (a) products produced from GMOs that are derived in whole or in part from GMOs, but do not themselves contain or consist of GMOs (e.g. potatoes produced from GMO seed potatoes); (b) products produced by GMOs that are derived using a GMO as the last living organism in the production process, but do not themselves contain or consist of GMOs, nor are they produced from GMOs (e.g. sugar and starch manufactured from a GMO vegetable source). Certification: a certification system which identifies the producers who comply with the rules governing organic production and the labelling of organic products. Because small farmers individually face relatively high inspection costs and administrative burdens linked to organic certification, a system of group certification is introduced and defined, reflecting the needs and resource capacity of these farmers. MAIN DOCUMENT Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, pp. 1-92) Successive amendments to Regulation (EU) 2018/848 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Delegated Regulation (EU) 2021/771 of 21 January 2021 supplementing Regulation (EU) 2018/848 of the European Parliament and of the Council by laying down specific criteria and conditions for the checks of documentary accounts in the framework of official controls in organic production and the official controls of groups of operators (OJ L 165, 11.5.2021, pp. 25-27) Commission Delegated Regulation (EU) 2021/715 of 20 January 2021 amending Regulation (EU) 2018/848 of the European Parliament and of the Council as regards the requirements for groups of operators (OJ L 151, 3.5.2021, pp. 1-4) Commission Delegated Regulation (EU) 2021/716 of 9 February 2021 amending Annex II to Regulation (EU) 2018/848 of the European Parliament and of the Council as regards organic production rules on sprouted seeds and chicory heads, on feed for certain aquaculture animals and on aquaculture parasite treatments (OJ L 151, 3.5.2021, pp. 5-7) Commission Delegated Regulation (EU) 2021/642 of 30 October 2020 amending Annex III to Regulation (EU) 2018/848 of the European Parliament and of the Council as regards certain information to be provided on the labelling of organic products (OJ L 133, 20.4.2021, pp. 1-4) Commission Delegated Regulation (EU) 2020/2146 of 24 September 2020 supplementing Regulation (EU) 2018/848 of the European Parliament and of the Council as regards exceptional production rules in organic production (OJ L 428, 18.12.2020, pp. 5-8) Commission Delegated Regulation (EU) 2020/1794 of 16 September 2020 amending Part I of Annex II to Regulation (EU) 2018/848 of the European Parliament and of the Council as regards the use of in-conversion and non-organic plant reproductive material (OJ L 402, 1.12.2020, pp. 23-26) See consolidated version. Commission Implementing Regulation (EU) 2020/464 of 26 March 2020 laying down certain rules for the application of Regulation (EU) 2018/848 of the European Parliament and of the Council as regards the documents needed for the retroactive recognition of periods for the purpose of conversion, the production of organic products and information to be provided by Member States (OJ L 98, 31.3.2020, pp. 2-25) See consolidated version. Commission Delegated Regulation (EU) 2020/427 of 13 January 2020 amending Annex II to Regulation (EU) 2018/848 of the European Parliament and of the Council as regards certain detailed production rules for organic products (OJ L 87, 23.3.2020, pp. 1-3) See consolidated version. Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1-142) See consolidated version. Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, pp. 1-23) See consolidated version. last update 29.06.2021

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30.7.2014 EN Official Journal of the European Union L 225/1 REGULATION (EU) No 806/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Central Bank (1), Having regard to the opinion of the European Economic and Social Committee (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Over the past decades the Union has made progress in creating an internal market for banking services. A better integrated internal market for banking services is essential in order to foster economic growth in the Union and adequate funding of the real economy. However, the financial and economic crisis has shown that the functioning of the internal market in this area is under threat and that there is an increasing risk of financial fragmentation. This is a real source of concern in an internal market in which banks should be able to carry out significant cross-border activities. Interbank markets have become less liquid and cross-border bank activities are decreasing due to fear of contagion, lack of confidence in other national banking systems and in the ability of Member States to support banks. (2) Divergences between national resolution rules in different Member States and corresponding administrative practices and the lack of a unified decision-making process for resolution in the banking union contribute to that lack of confidence and market instability, as they do not ensure predictability as to the possible outcome of a bank failure. (3) In particular, the different incentives and practices of Member States in the treatment of creditors of banks under resolution and in the bail-out of failing banks with tax payers' money have an impact on the perceived credit risk, financial soundness and solvency of their banks and thus create an unlevel playing field. This undermines public confidence in the banking sector and obstructs the exercise of the freedom of establishment and the free provision of services within the internal market because financing costs would be lower without such differences in practices of Member States. (4) Divergences between national resolution rules in different Member States and corresponding administrative practices may lead banks and customers to have higher borrowing costs only because of their place of establishment and irrespective of their real creditworthiness. In addition, customers of banks in some Member States face higher borrowing rates than customers of banks in other Member States, irrespective of their own creditworthiness. (5) The European Council on 18 October 2012 concluded that, ‘In the light of the fundamental challenges facing it, the Economic and Monetary Union needs to be strengthened to ensure economic and social welfare as well as stability and sustained prosperity’ and ‘that the process towards deeper economic and monetary union should build on the Union institutional and legal framework and be characterised by openness and transparency towards Member States whose currency is not the euro and by respect for the integrity of the internal market’. To that end a banking union is established, underpinned by a comprehensive and detailed single rulebook for financial services for the internal market as a whole. The process towards establishing a banking union is characterised by openness and transparency towards non-participating Member States and by respect for the integrity of the internal market. (6) The European Parliament, in its resolution of 7 July 2010 with recommendations to the Commission on Cross-Border Crisis Management in the Banking Sector, requested the Commission to submit ‘on the basis of Articles 50 and 114 of the Treaty on the Functioning of the European Union, one or more legislative proposals relating to an EU crisis-management framework, an EU financial stability fund, and a resolution unit’ and, in its resolution of 20 November 2012 with recommendations to the Commission on the report of the Presidents of the European Council, the European Commission, the European Central Bank and the Eurogroup ‘Towards a genuine Economic and Monetary Union’, stated that ‘breaking up the negative feedback loops between sovereigns, banks and the real economy is crucial for a smooth functioning of the EMU’, stressed the ‘urgent need for additional and far-reaching measures to solve the crisis in the banking sector’ and for the ‘realisation of a fully operational European banking union’ while ensuring ‘the continued proper functioning of the internal market for financial services and the free movement of capital’. (7) As a first step towards a banking union, the single supervisory mechanism established by Council Regulation (EU) No 1024/2013 (4) (the ‘SSM’) is to ensure that the Union's policy relating to the prudential supervision of credit institutions is implemented in a coherent and effective manner, that the single rulebook for financial services is applied in the same manner to credit institutions in the euro area Member States and those non-euro area Member States who choose to participate in the SSM (the ‘participating Member States’), and that those credit institutions are subject to supervision of the highest quality. (8) More efficient resolution mechanisms are an essential instrument to avoid damages that have resulted from failures of banks in the past. (9) As long as resolution rules, practices and approaches to burden-sharing remain national and the financial resources needed for funding resolution are raised and spent at national level, the internal market will remain fragmented. Moreover, national supervisors have strong incentives to minimise the potential impact of bank crises on their national economies by adopting unilateral action to ring-fence banking operations, for instance by limiting intra-group transfers and lending, or by imposing higher liquidity and capital requirements on subsidiaries in their jurisdictions of potentially failing parent undertakings. This restricts the cross-border activities of banks and thus creates obstacles to the exercise of fundamental freedoms and distorts competition in the internal market. Contentious home-host issues, although addressed in the context of SSM and of Directive 2014/59/EU of the European Parliament and of the Council (5), may still reduce efficiency in cross-border resolution processes. (10) In order to address those issues it has been necessary to intensify the integration of the resolution framework for credit institutions and investment firms (‘institutions’) in order to bolster the Union, restore financial stability and lay the basis for economic recovery. Directive 2014/59/EU is a significant step towards harmonisation of the rules relating to the resolution of banks across the Union and provides for cooperation among resolution authorities when dealing with the failure of cross-border banks. However, that Directive establishes minimum harmonisation rules and does not lead to centralisation of decision making in the field of resolution. It essentially provides for common resolution tools and resolution powers available for the national authorities of every Member State, but leaves discretion to national authorities in the application of the tools and in the use of national financing arrangements in support of resolution procedures. This ensures that authorities have the tools to intervene sufficiently early and quickly in an unsound or failing institution so as to ensure the continuity of the institution's critical financial and economic functions while minimising the impact of an institution's failure on the economy and financial system. Although it confers regulatory and mediation tasks on the European Supervisory Authority (European Banking Authority) (‘EBA’), established by Regulation (EU) No 1093/2010 of the European Parliament and of the Council (6), Directive 2014/59/EU does not completely avoid the taking of separate and potentially inconsistent decisions by Member States regarding the resolution of cross-border groups which may affect the overall costs of resolution. Moreover, as it provides for national financing arrangements, it does not sufficiently reduce the dependence of banks on the support from national budgets and does not completely prevent different approaches by Member States to the use of the financing arrangements. (11) For participating Member States, in the context of the Single Resolution Mechanism (SRM), a centralised power of resolution is established and entrusted to the Single Resolution Board established in accordance with this Regulation (‘the Board’) and to the national resolution authorities. That establishment is an integral part of the process of harmonisation in the field of resolution operated by Directive 2014/59/EU and by the set of uniform provisions on resolution laid down in this Regulation. The uniform application of the resolution regime in the participating Member States will be enhanced as a result of it being entrusted to a central authority such as the SRM. Furthermore, the SRM is interwoven with the process of harmonisation in the field of prudential supervision, brought about by the establishment of EBA, the single rulebook on prudential supervision (Regulation (EU) No 575/2013 of the European Parliament and of the Council (7) and Directive 2013/36/EU of the European Parliament and of the Council (8)), and, in the participating Member States, the establishment of the SSM to which the application of Union prudential supervision rules is entrusted. Supervision and resolution are two complementary aspects of the establishment of the internal market for financial services whose application at the same level is regarded as mutually dependent. (12) Ensuring effective resolution decisions for failing banks within the Union, including on the use of funding raised at Union level, is essential for the completion of the internal market in financial services. Within the internal market, the failure of banks in one Member State may affect the stability of the financial markets of the Union as a whole. Ensuring effective and uniform resolution rules and equal conditions of resolution financing across Member States is in the best interests not only of the Member States in which banks operate but also of all Member States in general as a means of ensuring a level competitive playing field and improving the functioning of the internal market. Banking systems in the internal market are highly interconnected, bank groups are international and banks have a large percentage of foreign assets. In the absence of the SRM, bank crises in Member States participating in the SSM would have a stronger negative systemic impact also in non-participating Member States. The establishment of the SRM will ensure a neutral approach in dealing with failing banks and therefore increase stability of the banks of the participating Member States and prevent the spill-over of crises into non-participating Member States and will thus facilitate the functioning of the internal market as a whole. The mechanisms for cooperation regarding institutions established in both participating and non-participating Member States should be clear, and no Member State or group of Member States should be discriminated against, directly or indirectly, as a venue for financial services. (13) In order to restore trust and credibility in the banking sector, the European Central Bank (ECB) is currently conducting a comprehensive balance sheet assessment of all banks supervised directly. Such an assessment should assure all stakeholders that banks entering the SSM, and therefore falling within the scope of the SRM, are fundamentally sound and trustworthy. (14) Following the establishment of the SSM by Regulation (EU) No 1024/2013 pursuant to which banks in the participating Member States are supervised either centrally by the ECB or by the national competent authorities within the framework of the SSM, there is a misalignment between the Union supervision of such banks and the national treatment of those banks in the resolution proceedings pursuant to Directive 2014/59/EU which will be addressed by the establishment of the SRM. (15) This Regulation applies only in respect of banks whose home supervisor is the ECB or the national competent authority in Member States whose currency is the euro or in Member States whose currency is not the euro which have established a close cooperation in accordance with Article 7 of Regulation (EU) No 1024/2013. The scope of application of this Regulation is linked to the scope of application of Regulation (EU) No 1024/2013. Indeed, bearing in mind the significant level to which the supervisory tasks attributed to the SSM and resolution action are interwoven, the establishment of a centralised system of supervision operated under Article 127(6) of the Treaty on the Functioning of the European Union (TFEU) is fundamentally important to the process of harmonisation of resolution in participating Member States. The fact of being subject to supervision by the SSM constitutes a specific attribute that places the entities falling within the scope of application of Regulation (EU) No 1024/2013 in an objectively and characterised distinct position for resolution purposes. It is necessary to adopt measures to create an SRM for all Member States participating in the SSM in order to facilitate the proper and stable functioning of the internal market. (16) Whilst banks in Member States remaining outside the SSM are subject to supervision, resolution and financial backstop arrangements which are aligned at national level, banks in Member States participating in the SSM are subject to Union arrangements for supervision and national arrangements for resolution and financial backstops. Because supervision and resolution are at two different levels within the SSM, intervention and resolution in banks in the Member States participating in the SSM would not be as rapid, consistent and effective as in banks in the Member States outside of the SSM. Therefore, a centralised resolution mechanism for all banks operating in the Member States participating in the SSM is essential to guarantee a level playing field. (17) As long as supervision in a Member State remains outside the SSM, that Member State should remain responsible for the financial consequences of a bank failure. The SRM should therefore extend only to banks and financial institutions established in Member States participating in the SSM and subject to the supervision of the ECB and the national authorities within the framework of the SSM. Banks established in the Member States not participating in the SSM should not be subject to the SRM. Subjecting such Member States to the SRM would create the wrong incentives for them. In particular, supervisors in those Member States may become more lenient towards banks in their jurisdictions as they would not have to bear the full financial risk of their failures. Therefore, in order to ensure parallelism with the SSM, the SRM should apply to Member States participating in the SSM. As Member States join the SSM, they should also automatically become subject to the SRM. Ultimately, the SRM could potentially extend to the entire internal market. (18) In order to ensure a level playing field within the internal market as a whole, this Regulation is consistent with Directive 2014/59/EU. It therefore adapts the rules and principles of that Directive to the specificities of the SRM and ensures that appropriate funding is available to the latter. When the Board, the Council and the Commission exercise the powers conferred on them by this Regulation, they should be subject to the delegated acts, and regulatory and implementing technical standards, guidelines and recommendations adopted by EBA on the basis of respectively Articles 10 to 15 and Article 16 of Regulation (EU) No 1093/2010 within the scope of Directive 2014/59/EU. The Board, the Council and the Commission, in their respective capacities, should also cooperate with EBA in accordance with Articles 25 and 30 of Regulation (EU) No 1093/2010 and respond to requests of collection of information addressed to them by EBA in accordance with Article 35 of that Regulation. It is recalled that, according to the last sentence of Recital 32 of that Regulation, ‘in cases where the relevant Union legislation confers discretion on […] competent authorities, decisions taken by the Authority cannot replace the exercise in compliance with Union law of that discretion’. The same principle should extend to this Regulation, while fully respecting the principles enshrined in primary Union law. In the light of those key elements EBA should be able to perform its tasks effectively and to secure the equality of treatment between the Board, the Council, the Commission and the national authorities when performing similar tasks. (19) A single resolution fund (‘Fund’) is an essential element without which the SRM could not work properly. If the funding of resolution were to remain national in the longer term, the link between sovereigns and the banking sector would not be fully broken, and investors would continue to establish borrowing conditions according to the place of establishment of the banks rather than to their creditworthiness. The Fund should help to ensure a uniform administrative practice in the financing of resolution and to avoid the creation of obstacles for the exercise of fundamental freedoms or the distortion of competition in the internal market due to divergent national practices. The Fund should be financed by bank contributions raised at national level and should be pooled at Union level in accordance with an intergovernmental agreement on the transfer and progressive mutualisation of those contributions (the ‘Agreement’), thus increasing financial stability and limiting the link between the perceived fiscal position of individual Member States and the funding costs of banks and undertakings operating in those Member States. To further break that link, decisions taken within the SRM should not impinge on the fiscal responsibilities of the Member States. In that regard, only extraordinary public financial support should be considered to be an impingement on the budgetary sovereignty and fiscal responsibilities of the Member States. In particular, decisions that require the use of the Fund or of a deposit guarantee scheme should not be considered to impinge on the budgetary sovereignty or fiscal responsibilities of the Member States. (20) This Regulation, together with Directive 2014/59/EU, establishes the modalities for the use of the Fund and the general criteria to determine the fixing and calculation of ex-ante and ex-post contributions. Participating Member States remain competent to levy the contributions from the entities located in their respective territories in accordance with Directive 2014/59/EU and with this Regulation. By means of the Agreement, the participating Member States will assume the obligation to transfer to the Fund the contributions that they raise at national level in accordance with Directive 2014/59/EU and this Regulation. During a transitional period, the contributions will be allocated to different compartments corresponding to each participating Member State (national compartments). Those compartments will be subject to a progressive merger so that they will cease to exist at the end of the transitional period. The Agreement will lay down the conditions upon which the parties thereto agree to transfer the contributions that they raise at national level to the Fund and to progressively merge the compartments. The entry into force of the Agreement will be necessary for the contributions raised by the parties to be transferred to the national compartments of the Fund. This Regulation lays down the powers of the Board for using and managing the Fund. The Agreement will determine how the Board is able to dispose of the national compartments that are progressively merged. (21) A centralised application of the resolution rules for institutions laid down in Directive 2014/59/EU by a single Union resolution authority in the participating Member States can be ensured only where the rules governing the establishment and functioning of the SRM are directly applicable in the Member States to avoid divergent interpretations across the Member States. Such direct applicability should bring benefits to the internal market as a whole because it will contribute to ensuring fair competition and to preventing obstacles to the free exercise of fundamental freedoms not only in the participating Member States but in the internal market as a whole. (22) Mirroring the scope of Regulation (EU) No 1024/2013, the SRM should cover all credit institutions established in the participating Member States. However, within the framework of the SRM, it should be possible to resolve directly any credit institution of a participating Member State in order to avoid asymmetries within the internal market in respect of the treatment of failing institutions and creditors during a resolution process. To the extent that parent undertakings, investment firms and financial institutions are included in the consolidated supervision by the ECB, they should be included in the scope of the SRM. Although the ECB will not supervise those institutions on a solo basis, it will be the only supervisor that will have a global perception of the risk which a group, and indirectly its individual members, is exposed to. To exclude entities which form part of the consolidated supervision within the scope of the ECB from the scope of the SRM would make it impossible to plan for the resolution of groups and to adopt a group resolution strategy, and would make any resolution decisions much less effective. (23) Within the SRM, decisions should be taken at the most appropriate level. When adopting decisions under this Regulation, the Board and the national resolution authorities should apply the same material rules. (24) Since only institutions of the Union may establish the resolution policy of the Union and since a margin of discretion remains in the adoption of each specific resolution scheme, it is necessary to provide for the adequate involvement of the Council and the Commission, as institutions which may exercise implementing powers, in accordance with Article 291 TFEU. The assessment of the discretionary aspects of the resolution decisions taken by the Board should be exercised by the Commission. Given the considerable impact of the resolution decisions on the financial stability of Member States and on the Union as such, as well as on the fiscal sovereignty of Member States, it is important that implementing power to take certain decisions relating to resolution be conferred on the Council. It should therefore be for the Council, on a proposal from the Commission, to exercise effective control on the assessment by the Board of the existence of a public interest and to assess any material change to the amount of the Fund to be used in a specific resolution action. Moreover, the Commission should be empowered to adopt delegated acts to specify further criteria or conditions to be taken into account by the Board in the exercise of its different powers. Such a conferral of resolution tasks should not in any way hamper the functioning of the internal market for financial services. EBA should therefore maintain its role and retain its existing powers and tasks: it should develop and contribute to the consistent application of the Union legislation applicable to all Member States and enhance convergence of resolution practices across the Union as a whole. (25) In order to ensure conformity with the principles established in Article 3(3) of Directive 2014/59/EU, the Union institutions, when performing the tasks conferred on them by this Regulation, should ensure that appropriate organisational arrangements are in place. (26) The ECB, as the supervisor within the SSM, and the Board, should be able to assess whether a credit institution is failing or is likely to fail and whether there is no reasonable prospect that any alternative private sector or supervisory action would prevent its failure within a reasonable timeframe. The Board, if it considers all the criteria relating to the triggering of resolutions to be met, should adopt the resolution scheme. The procedure relating to the adoption of the resolution scheme, which involves the Commission and the Council, strengthens the necessary operational independence of the Board while respecting the principle of delegation of powers to agencies as interpreted by the Court of Justice of the European Union (the ‘Court of Justice’). Therefore, this Regulation provides that the resolution scheme adopted by the Board enters into force only if, within 24 hours after its adoption by the Board, there are no objections from the Council or the Commission or the resolution scheme is approved by the Commission. The grounds on which the Council is permitted to object, on a proposal by the Commission, to the Board's resolution scheme should be strictly limited to the existence of a public interest and to material modifications by the Commission of the amount of the use of the Fund as proposed by the Board. A change of 5 % or more to the amount of the Fund compared with the original proposal of the Board should be considered to be material. The Council should approve or object to the Commission's proposal without amending it. As an observer to the meetings of the Board, the Commission should, on an ongoing basis, check that the resolution scheme adopted by the Board complies fully with this Regulation, balances appropriately the different objectives and interests at stake, respects the public interest and that the integrity of the internal market is preserved. Considering that the resolution action requires a very speedy decision-making process, the Council and the Commission should cooperate closely and the Council should not duplicate the preparatory work already undertaken by the Commission. The Board should instruct the national resolution authorities which should take all necessary measures to implement the resolution scheme. (27) The production of a group resolution scheme should facilitate coordinated resolution that is more likely to deliver the best result for all entities of a group. The Board or, where relevant, the national resolution authorities should have the power to apply the bridge institution tool at group level (which may involve, where appropriate, burden-sharing arrangements) to stabilise a group as a whole. Ownership of subsidiaries could be transferred to the bridge institution with a view to onward sale, either as a package or individually, when market conditions are appropriate. In addition, the Board or, where relevant, the national resolution authority should have the power to apply the bail-in tool at parent level. (28) The Board should, in particular, be empowered to take decisions in relation to significant entities or groups, entities or groups directly supervised by the ECB or cross-border groups. The national resolution authorities should assist the Board in resolution planning and in the preparation of resolution decisions. For entities and groups which are not significant and not cross-border, the national resolution authorities should be responsible, in particular, for resolution planning, the assessment of resolvability, the removal of impediments to resolvability, the measures that the resolution authorities are entitled to take during early intervention, and resolution actions. Under certain circumstances the national resolution authorities should perform their tasks on the basis of and in accordance with this Regulation while exercising the powers conferred on them by, and in accordance with, the national law transposing Directive 2014/59/EU in so far as it is not in conflict with this Regulation. (29) It is essential for the good functioning of the internal market that the same rules apply to all resolution actions, regardless of whether they are taken by the resolution authorities under Directive 2014/59/EU or within the framework of the SRM. The Commission should assess those measures under Article 107 TFEU. (30) Where resolution action would involve the granting of State aid pursuant to Article 107(1) TFEU or as Fund aid, a resolution decision can be adopted after the Commission has adopted a positive or conditional decision concerning the compatibility of the use of such aid with the internal market. The decision of the Commission on Fund aid may impose conditions, commitments or undertakings in respect of the beneficiary. The conditions which may be imposed by the Commission may include, but are not limited to, burden-sharing requirements, including a requirement that losses are first absorbed by equity, and requirements as to contributions by hybrid capital holders, subordinated debt holders and senior creditors, including in accordance with the requirements of Directive 2014/59/EU; restrictions on the payment of dividends on shares or coupons on hybrid capital instruments, on the repurchase of own shares or hybrid capital instruments, or on capital management transactions; restrictions on acquisitions of stakes in any undertaking either through an asset or share transfer; prohibitions against aggressive commercial practices or strategies, or advertising support from public aid; requirements concerning market shares, pricing, product features or other behavioural requirements; requirements for restructuring plans; governance requirements; reporting and disclosure requirements, including as regards compliance with such conditions as may be specified by the Commission; requirements relating to the sale of the beneficiary or of all or part of its assets, rights and liabilities; requirements relating to the liquidation of the beneficiary. (31) In order to ensure a swift and effective decision-making process in resolution, the Board should be a specific Union agency with a specific structure, corresponding to its specific tasks, and which departs from the model of all other agencies of the Union. Its composition should ensure that due account is taken of all relevant interests at stake in resolution procedures. Taking into account the missions of the Board, a Chair, a Vice-Chair and four further full-time members of the Board should be appointed on the basis of merit, skills, knowledge of banking and financial matters, and experience relevant to financial supervision, regulation and resolution of institutions. The Chair, the Vice-Chair and the four further full-time members of the Board should be chosen on the basis of an open selection procedure of which the European Parliament and the Council should be kept duly informed and which should respect the principle of gender balance, experience and qualification. The Commission should provide the competent committee of the European Parliament with the shortlist of candidates for the positions of Chair, Vice-Chair and the four further full-time members of the Board. The Commission should submit a proposal for the appointment of the Chair, the Vice-Chair and the four further full-time members of the Board to the European Parliament for approval. Following the European Parliament's approval of that proposal, the Council should adopt an implementing decision to appoint the Chair, the Vice-Chair and the four further full-time members of the Board. (32) The Board should operate in executive and plenary sessions. In its executive session, it should be composed of its Chair, its four further independent full-time members, which should act independently and objectively in the interest of the Union as a whole, and permanent observers appointed by the Commission and by the ECB. When deliberating on the resolution of an institution or group established within a single participating Member State, the executive session of the Board should convene and involve in the decision-making process the member appointed by the Member State concerned representing its national resolution authority. When deliberating on a cross-border group, the members appointed by the home and all host Member States concerned representing the relevant national resolution authorities should be convened and involved in the decision-making process of the executive session of the Board. (33) The Board, in its executive session, should prepare all decisions concerning resolution procedure and, to the fullest extent possible, adopt those decisions. Because of the institution-specific nature of the information contained in the resolution plans, decisions concerning the drawing up, assessment, and approval of the resolution plans should be taken by the Board in its executive session. Regarding the use of the Fund, it is important that there is no first-mover advantage and that the outflows of the Fund are monitored. In order to ensure corresponding decision making by the Board, where resolution action is required above the threshold of EUR 5 000 000 000, any member of the plenary should be able, within a strict deadline, to request that the plenary session decide. Where liquidity support involves no or significantly less risk than other forms of support, in particular in the case of a short-term, one-off extension of credit to solvent institutions against adequate collateral of high quality, it is justified to give such a form of support a lower weight of only 0,5. Once the net accumulated use of the Fund in the previous consecutive 12 months reaches the threshold of EUR 5 000 000 000 per year, the plenary session should evaluate the application of the resolution tools, including the use of the Fund, and should provide guidance which the executive session should follow in subsequent resolution decisions. Guidance to the executive session should, in particular, focus on ensuring the non-discriminatory application of resolution tools, on avoiding a depletion of the Fund and differentiating appropriately between no-risk or low-risk liquidity and other forms of support. (34) Since the participants in the decision-making process of the Board in its executive sessions would change depending on the Member State where the relevant institution or group operates, the permanent participants should ensure that the decisions throughout the different formations of the executive sessions of the Board are consistent, appropriate and proportionate. (35) The Board should be able to invite observers to its meetings. The conferral of resolution tasks on the Board should be consistent with the framework of the European System of Financial Supervision (‘ESFS’) and its underlying objective to develop the single rulebook and enhance convergence of supervisory and resolution practices across the Union as a whole. In particular, EBA should assess and coordinate initiatives, in accordance with Regulation (EU) No 1093/2010, on resolution plans with a view to promoting convergence in that area. Therefore, as a general rule, the Board should always invite EBA when matters are discussed for which, in accordance with Directive 2014/59/EU, EBA is required to develop technical standards or to issue guidelines. Other observers, such as a representative of the European Stability Mechanism (ESM), may, where appropriate, also be invited to attend the meetings of the Board. (36) The observers should be subject to the same requirements of professional secrecy as the members and the staff of the Board and staff exchanged with or seconded by participating Member States carrying out resolution duties. (37) The Board should be able to establish internal resolution teams composed of its own staff and staff of the national resolution authorities, including, where appropriate, observers from non-participating Member States. Those internal resolution teams should be headed by coordinators appointed from the Board's senior staff, who might be invited as observers to participate in the executive sessions of the Board. (38) The Board and the resolution authorities and competent authorities of the non-participating Member States should conclude memoranda of understanding describing in general terms how they will cooperate with one another in the performance of their tasks under Directive 2014/59/EU. The memoranda of understanding could, inter alia, clarify the consultation relating to decisions of the Board that have effect on subsidiaries established or branches located in the non-participating Member States, where the parent undertaking is established in a participating Member State. The memoranda should be reviewed on a regular basis. (39) The Board should act independently. It should have the capacity to deal with large groups and to act swiftly and impartially. The Board should ensure that appropriate account is taken of national financial stability, financial stability of the Union and the internal market. Members of the Board should have the necessary expertise on bank restructuring and insolvency. (40) When making decisions or taking actions in the exercise of the powers conferred by this Regulation, due account should be given to the importance for the internal market of the exercise of the right of establishment provided for in the TFEU, and, in particular, where possible, to the effects on the continuation of cross-border activities. (41) In the light of the Board's missions and the resolution objectives which include the protection of public funds, the functioning of the SRM should be financed from contributions paid by the institutions established in the participating Member States. (42) The Board, the Council where relevant, and the Commission should replace the national resolution authorities designated under Directive 2014/59/EU in respect of all aspects relating to the resolution decision-making process. The national resolution authorities designated under that Directive should continue to carry out activities relating to the implementation of resolution schemes adopted by the Board. In order to ensure transparency and democratic control, as well as to safeguard the rights of the Union institutions, the Board should be accountable to the European Parliament and to the Council for any decisions taken on the basis of this Regulation. For reasons of transparency and democratic control, national parliaments should have certain rights to obtain information about the activities of, and to engage in a dialogue with, the Board. (43) The national parliament of a participating Member State, or the competent committee thereof, should be able to invite the Chair to participate in an exchange of views in relation to the resolution of institutions in that Member State together with a representative of the national resolution authority. Such a role for national parliaments is appropriate given the potential impact that resolution actions may have on public finances, institutions, their customers and employees, and the markets in the participating Member States. The Chair and the national resolution authorities should respond positively to such invitations to exchange views with the national parliaments. (44) To ensure a uniform approach for institutions and groups the Board should be empowered to draw up resolution plans for such institutions and groups, after consulting the national competent and resolution authorities. It should be the general rule that the group resolution plans are prepared for the group as a whole and identify measures in relation to a parent undertaking as well as all individual subsidiaries that are part of a group. The group resolution plans should take into account the financial, technical and business structure of the relevant group. If individual resolution plans for entities that are a part of a group are prepared, the Board or, where relevant, the national resolution authorities should aim to achieve, to the extent possible, consistency with resolution plans for the rest of the group. The Board or, where relevant, the national resolution authorities should transmit the resolution plans and any changes thereto to the competent authority, in order to permanently keep it fully informed. The Board should assess the resolvability of institutions and groups, and take measures aimed at removing impediments to resolvability, if any. The Board should require the national resolution authorities to apply such appropriate measures designed to remove impediments to resolvability in order to ensure consistency and the resolvability of the institutions concerned. Given the sensitivity of the information contained in them, resolution plans should be subject to the requirements of professional secrecy laid down in this Regulation. (45) When applying resolution tools and exercising resolution powers, the principle of proportionality and the particularities of the legal form of an institution should be taken into account. (46) Resolution planning is an essential component of effective resolution. The Board should therefore have the power to require changes to the structure and organisation of institutions or groups to take measures which are necessary and proportionate to reduce or remove material impediments to the application of resolution tools and ensure the resolvability of the entities concerned. Due to the potentially systemic nature of all institutions, it is crucial, in order to maintain financial stability, that the Board, or, where relevant, the national resolution authorities, have the possibility to resolve any institution. In order to respect the right to conduct business laid down by Article 16 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), the Board's discretion should be limited to what is necessary to simplify the structure and operations of the institution solely to improve its resolvability. In addition, any measure imposed for such purposes should be consistent with Union law. Measures should neither directly nor indirectly be discriminatory on grounds of nationality, and should be justified by the overriding reason of being conducted in the public interest in financial stability. To determine whether an action was taken in the general public interest, the Board, acting in the general public interest, should be able to achieve the resolution objectives without encountering impediments to the application of resolution tools or its ability to exercise the powers conferred on it by this Regulation. Furthermore, action should not go beyond the minimum necessary to attain the objectives sought. When determining the measures to be taken, the Board or, where applicable, the national resolution authorities should take into account the warnings and recommendations of the European Systemic Risk Board (‘ESRB’) established by Regulation (EU) No 1092/2010 of the European Parliament and of the Council (9). (47) Due to the potentially systemic nature of all institutions, it is crucial that the Board, where appropriate in cooperation with the national resolution authorities, is able to adopt resolution plans, assess the resolvability of any institution and group and, where necessary, take measures to address or remove impediments to the resolvability of any institution in the participating Member States. The failure of systemically important institutions, including those referred to in Article 131 of Directive 2013/36/EU, could pose a considerable risk to the functioning of the financial markets and could have a negative impact on financial stability. The Board should take due care, as a matter of priority, to establish the resolution plans of those systemically important institutions, as well as to assess their resolvability and to take all action necessary to address or remove all of the impediments to their resolvability, without prejudice to its independence and to its obligation to plan for the resolution and assess the resolvability of all of the institutions subject to its powers. (48) Resolution plans should include procedures for informing and consulting employee representatives throughout the resolution processes where appropriate. Where applicable, collective agreements or other arrangements provided for by social partners, as well as by Union and national law on the involvement of trade unions and workers' representatives in company restructuring processes, should be complied with in that regard. (49) In relation to the obligation of drafting resolution plans, the Board, or, where relevant, the national resolution authorities, in the context of resolution plans and when using the different powers and tools at their disposal, should take into account the nature of an entity's business, shareholding structure, legal form, risk profile, size and legal status and interconnectedness to other institutions or to the financial system in general, the scope and complexity of its activities, whether it is a member of an institutional protection scheme (IPS) or other cooperative mutual solidarity systems, whether it exercises any investment services or activities and whether its failure and subsequent winding up under normal insolvency proceedings would be likely to have a significant negative effect on financial markets, on other institutions, on funding conditions, or on the wider economy, ensuring that the regime is applied in an appropriate and proportionate way and that the administrative burden relating to resolution plan preparation obligations is minimised. Whereas the contents and information specified in Section A of the Annex to Directive 2014/59/EU establish a minimum standard for entities with evident systemic relevance, it is permitted to apply different or significantly reduced resolution planning and information requirements on an institution-specific basis, and at a lower frequency for updates than one year. For a small entity of little interconnectedness and complexity, the resolution plan could be reduced. Further, the regime should be applied so as not to jeopardise the stability of financial markets. In particular, in situations characterised by broader problems or even doubts about the resilience of many entities, it is essential to consider the risk of contagion from the actions taken in relation to any individual entity. (50) Where Directive 2014/59/EU provides for the possibility of applying simplified obligations or waivers by the national resolution authorities in relation to the requirement of drafting resolution plans, a procedure should be provided for whereby the Board or, where relevant, the national resolution authorities could authorise the application of such simplified obligations. (51) In line with the capital structure of entities affiliated to a central body, for the purposes of this Regulation, the Board, or, where relevant, the national resolution authorities, should not be obliged to draw up separate resolution plans solely on the grounds that the central body to which those entities are affiliated is under direct supervision of the ECB. In the case of group resolution plans, the potential impact of the resolution actions in all the Member States where the group operates should be specifically taken into account in the drawing up of the plans. (52) The SRM should be based on the frameworks of Regulation (EU) No 1024/2013 and of Directive 2014/59/EU. Therefore, the Board should be empowered to intervene at an early stage where the financial situation or the solvency of an entity is deteriorating. The information that the Board receives from the national resolution authorities or the ECB at that stage is instrumental in making a determination on the action it might take in order to prepare for the resolution of the entity concerned. (53) In order to ensure rapid resolution action when it becomes necessary, the Board should closely monitor, in cooperation with the ECB or with the relevant national competent authority, the situation of the entities concerned and the compliance of those entities with any early intervention measure taken in their respect. In determining whether a private sector action could prevent within a reasonable timeframe the failure of an entity, the appropriate authority should take into account the effectiveness of early intervention measures undertaken within a timeframe set by the competent authority. (54) The Board, the national resolution authorities and the competent authorities, including the ECB, should, where necessary, conclude a memorandum of understanding describing in general terms how they will cooperate with one another in the performance of their respective tasks under Union law. The memorandum should be reviewed on a regular basis. (55) When making decisions or taking actions, in particular regarding entities established both in participating Member States and in non-participating Member States, possible adverse effects on those Member States, such as threats to the financial stability of their financial markets, and on the entities established in those Member States, should also be taken into consideration. (56) In order to minimise disruption of the financial market and of the economy, the resolution process should be accomplished in a short time. Depositors should be granted access at least to the guaranteed deposits as promptly as possible, and in any event within the same deadlines as provided for in Directive 2014/49/EU of the European Parliament and of the Council (10). The Commission should, throughout the resolution procedure, have access to any information which it deems to be necessary to take an informed decision in the resolution process. (57) The decision to place an entity under resolution should be taken before a financial entity is balance sheet insolvent and before all equity has been fully wiped out. Resolution should be initiated after the determination that an entity is failing or is likely to fail and that no alternative private sector measures would prevent such failure within a reasonable timeframe. The fact that an entity does not meet the requirements for authorisation should not justify per se the entry into resolution, especially if the entity remains or is likely to remain viable. An entity should be considered to be failing or likely to fail where it infringes or is likely, in the near future, to infringe the requirements for continuing authorisation, where the assets of the entity are, or are likely in the near future to be, less than its liabilities, where the entity is, or is likely in the near future to be, unable to pay its debts as they fall due, or where the entity requires extraordinary public financial support except in the particular circumstances laid down in this Regulation. The need for emergency liquidity assistance from a central bank should not, per se, be a condition that sufficiently demonstrates that an entity is, or is likely in the near future to be, unable to pay its liabilities as they fall due. If that facility were guaranteed by a State, an entity accessing such a facility would be subject to State aid rules. In order to preserve financial stability, in particular in the event of a systemic liquidity shortage, State guarantees of liquidity facilities provided by central banks or State guarantees of newly issued liabilities to remedy a serious disturbance in the economy of a Member State should not trigger the resolution framework provided that a number of conditions are met. In particular, the State guarantee measures should be approved under the State aid framework and should not be part of a larger aid package, and the use of the guarantee measures should be strictly limited in time. Member States' guarantees for equity claims should be prohibited. When providing a guarantee, a Member State should ensure that the guarantee is sufficiently remunerated by the entity. Furthermore, the provision of extraordinary public financial support should not trigger resolution where, as a precautionary measure, a Member State takes an equity stake in an entity, including an entity which is publicly owned, which complies with its capital requirements. That may be the case, for example, where an entity is required to raise new capital due to the outcome of a scenario-based stress test or of the equivalent exercise conducted by macroprudential authorities which includes a requirement that is set to maintain financial stability in the context of a systemic crisis, but the entity is unable to raise capital privately in markets. An entity should not be considered to be failing or likely to fail solely on the basis that extraordinary public financial support was provided before the entry into force of this Regulation. Finally, access to liquidity facilities including emergency liquidity assistance by central banks may constitute State aid pursuant to the State aid framework. (58) Liquidation of a failing entity under normal insolvency proceedings could jeopardise financial stability, interrupt the provision of essential services, and affect the protection of depositors. In such a case there is a public interest in applying resolution tools. The objectives of resolution should therefore be to ensure the continuity of essential financial services, to maintain the stability of the financial system, to reduce moral hazard by minimising reliance on public financial support to failing entities, and to protect depositors. (59) However, the winding up of an insolvent entity through normal insolvency proceedings should always be considered before a decision is taken to maintain the entity as a going concern. An insolvent entity should be maintained as a going concern for financial stability purposes and with the use, to the extent possible, of private funds. That may be achieved either through sale to or merger with a private sector purchaser, or after having written down the liabilities of the entity, or after converting its debt to equity in order to effect a recapitalisation. (60) When taking or preparing decisions relating to resolution powers, the Board, the Council and the Commission should ensure that resolution action is taken in accordance with certain principles, including that shareholders and creditors bear an appropriate share of the losses, that the management should in principle be replaced, that the costs of the resolution of the entity are minimised, and that creditors of the same class are treated in an equitable manner. In particular, where creditors within the same class are treated differently in the context of resolution action, such distinctions should be justified in the public interest and should be neither directly nor indirectly discriminatory on the grounds of nationality. (61) The limitations on the rights of shareholders and creditors should comply with Article 52 of the Charter. The resolution tools should therefore be applied only to those entities that are failing or likely to fail, and only where necessary to pursue the objective of financial stability in the general interest. In particular, resolution tools should be applied where the entity cannot be wound up under normal insolvency proceedings without destabilising the financial system and the measures are necessary in order to ensure the rapid transfer and continuation of systemically important functions and where there is no reasonable prospect for any alternative private solution, including any increase of capital by the existing shareholders or by any third party, sufficient to restore the full viability of the entity. (62) Interference with property rights should not be disproportionate. As a consequence, affected shareholders and creditors should not incur greater losses than those which they would have incurred had the entity been wound up at the time that the resolution decision is taken. In the event of partial transfer of assets of an institution under resolution to a private purchaser or to a bridge institution, the residual part of the institution under resolution should be wound up under normal insolvency proceedings. In order to protect shareholders and creditors of the entity during the winding up proceedings, they should be entitled to receive in payment of their claims not less than what it is estimated they would have recovered if the entity as a whole had been wound up under normal insolvency proceedings. (63) For the purpose of protecting the rights of shareholders and creditors, clear obligations should be laid down concerning the valuation of the assets and liabilities of the institution under resolution and, where required under this Regulation, the valuation of the treatment that shareholders and creditors would have received if the entity had been wound up under normal insolvency proceedings. It should be possible to commence a valuation already in the early intervention phase. Before any resolution action is taken, a fair, prudent and realistic valuation of the assets and liabilities of the entity should be carried out. Such valuation should be subject to a right of appeal only together with the resolution decision. In addition, where required under this Regulation, an ex-post comparison between the treatment that shareholders and creditors have received and the treatment they would have received under normal insolvency proceedings should be carried out after resolution tools have been applied. If it is determined that shareholders and creditors have received, in payment of their claims, less than the amount that they would have received under normal insolvency proceedings, they should be entitled to the payment of the difference where required under this Regulation. That difference, if any, should be paid by the Fund established in accordance with this Regulation. (64) It is important that losses be recognised upon failure of the entity. The valuation of assets and liabilities of failing entities should be based on fair, prudent and realistic assumptions at the moment when the resolution tools are applied. The value of liabilities should not, however, be affected in the valuation by the entity's financial state. It should be possible, for reasons of urgency, that the Board makes a rapid valuation of the assets or the liabilities of a failing entity. That valuation should be provisional and should apply until an independent valuation is carried out. (65) In order to ensure that the resolution process remains objective and certain, it is necessary to lay down the order in which unsecured claims of creditors against an institution under resolution should be written down or converted. In order to limit the risk of creditors incurring greater losses than if the institution had been wound up under normal insolvency proceedings, the order to be laid down should be applicable both in normal insolvency proceedings and in the write-down or conversion process under resolution. This would also facilitate the pricing of debt. (66) The Board should decide on the detailed resolution scheme. The relevant resolution tools should include the sale of business tool, the bridge institution tool, the bail-in tool and the asset separation tool, which are also provided for in Directive 2014/59/EU. The scheme should also make it possible to assess whether the conditions for the write-down and conversion of capital instruments are met. (67) When taking resolution actions, the Board should take into account and follow the measures provided for in the resolution plans unless the Board assesses, taking into account the circumstances of the case, that resolution objectives will be achieved more effectively by taking actions which are not provided for in those resolution plans. (68) The resolution tools should include the sale of the business or shares of the institution under resolution, the setting up of a bridge entity, the separation of the performing assets from the impaired or under-performing assets of the failing entity, and the bail-in of the shareholders and creditors of the failing entity. (69) Where the resolution tools have been used to transfer the systemically important services or viable business of an entity to a sound entity such as a private sector purchaser or bridge entity, the residual part of the entity should be liquidated. (70) The sale of business tool should enable the sale of the entity or parts of its business to one or more purchasers without the consent of shareholders. (71) Any net proceeds from the transfer of assets or liabilities of the institution under resolution when applying the sale of business tool should benefit the entity left in the winding-up proceedings. Any net proceeds from the transfer of instruments of ownership issued by the institution under resolution when applying the sale of business tool should benefit the owners of those instruments of ownership in the entity left in the winding up proceedings. Proceeds should be calculated net of the costs arisen from the failure of the entity and from the resolution process. (72) The asset separation tool should enable authorities to transfer assets, rights or liabilities of an institution under resolution to a separate vehicle. That tool should be used only in conjunction with other tools to prevent an undue competitive advantage for the failing entity. (73) An effective resolution regime should minimise the costs of the resolution of a failing entity borne by the taxpayers. It should also ensure that systemic entities can be resolved without jeopardising financial stability. The bail-in tool achieves that objective by ensuring that shareholders and creditors of the failing entity suffer appropriate losses and bear an appropriate part of the costs arising from the failure of the entity. The bail-in tool will therefore give shareholders and creditors of entities a stronger incentive to monitor the health of an entity during normal circumstances. It also meets the Financial Stability Board recommendation that statutory debt write-down and conversion powers be included in a framework for resolution, as an additional option in conjunction with other resolution tools. (74) In order to ensure the necessary flexibility to allocate losses to creditors in a range of circumstances, it is appropriate that the bail-in tool be applicable both where the objective is to resolve the failing entity as a going concern if there is a realistic prospect that the entity viability may be restored, and where systemically important services are transferred to a bridge entity and the residual part of the entity ceases to operate and is wound down. (75) Where the bail-in tool is applied with the objective of restoring the capital of the failing entity to enable it to continue to operate as a going concern, the resolution through bail-in should be accompanied by replacement of management, except where retention of management is appropriate and necessary for the achievement of the resolution objectives, and a subsequent restructuring of the entity and its activities in a way that addresses the reasons for its failure. That restructuring should be achieved through the implementation of a business reorganisation plan. Where applicable, such plans should be compatible with the restructuring plan that the entity is required to submit to the Commission under the Union State aid framework. In particular, in addition to measures aiming at restoring the long term viability of the entity, the plan should include measures limiting the aid to the minimum burden sharing, and measures limiting distortions of competition. (76) It is not appropriate to apply the bail-in tool to claims in so far as they are secured, collateralised or otherwise guaranteed. However, in order to ensure that the bail-in tool is effective and achieves its objectives, it is desirable that it can be applied to as wide a range of the unsecured liabilities of a failing entity as possible. Nevertheless, it is appropriate to exclude certain kinds of unsecured liability from the scope of application of the bail-in tool. In order to protect holders of covered deposits, the bail-in tool should not apply to those deposits that are protected under Directive 2014/49/EU. In order to ensure continuity of critical functions, the bail-in tool should not apply to certain liabilities to employees of the failing entity or to commercial claims that relate to goods and services critical for the daily functioning of the entity. In order to honour pension entitlements and pension amounts owed or owing to pension trusts and pension trustees, the bail-in tool should not apply to the failing entity's liabilities to a pension scheme, except for liabilities for pension benefits attributable to variable remuneration which do not arise from collective bargaining agreements. To reduce risk to systemic contagion, the bail-in tool should not apply to liabilities arising from a participation in payment systems which have a remaining maturity of less than seven days, or liabilities to entities, excluding entities that are part of the same group, with an original maturity of less than seven days. (77) It should be possible to exclude or partially exclude liabilities in a number of circumstances, including where it is not possible to bail-in such liabilities within a reasonable timeframe, where the exclusion is strictly necessary and is proportionate to achieving the continuity of critical functions and core business lines, or where the application of the bail-in tool to liabilities would cause a destruction in value such that losses borne by other creditors would be higher than if those liabilities were not excluded from bail-in. It should also be possible to exclude or partially exclude liabilities where necessary to avoid the spreading of contagion and financial instability which may cause serious disturbance to the economy of a Member State. When carrying out the assessments, the Board or, where relevant, the national resolution authorities should give consideration to the consequences of a potential bail-in of liabilities stemming from eligible deposits held by natural persons and micro, small and medium-sized enterprises above the coverage level provided for in Directive 2014/49/EU. (78) Where those exclusions are applied, the level of write-down or conversion of other eligible liabilities may be increased to take account of such exclusions subject to the ‘no creditor worse off than under normal insolvency proceedings’ principle being respected. Where the losses cannot be passed to other creditors, the Fund may make a contribution to the institution under resolution subject to a number of strict conditions including the requirement that losses totalling not less than 8 % of total liabilities including own funds have already been absorbed, and the funding provided by the Fund is limited to the lower of 5 % of total liabilities including own funds or the means available to the Fund and the amount that can be raised through ex-post contributions within three years. (79) In extraordinary circumstances, where liabilities have been excluded and the Fund has been used to contribute to bail-in in lieu of those liabilities up to the permissible cap, the Board should be able to seek funding from alternative funding means. (80) The minimum amount of bail-in of 8 % of total liabilities referred to in this Regulation should be calculated based on the valuation conducted in accordance with this Regulation. Historical losses which have already been absorbed by shareholders through a reduction in own funds prior to that valuation should not be included in that percentage. (81) As the protection of covered depositors is one of the most important objectives of resolution, covered deposits should not be subject to the exercise of the bail-in tool. The deposit guarantee scheme, however, contributes to funding the resolution process by absorbing losses to the extent of the net losses that it would have had to suffer after compensating depositors in normal insolvency proceedings. The exercise of the bail-in powers would ensure that depositors continue to have access to their deposits which is the main reason why the deposit guarantee schemes have been established. Not providing for the involvement of those schemes in such cases would constitute an unfair advantage with respect to the remaining creditors which would be subject to the exercise of the powers by the resolution authority. (82) Where deposits are transferred to another entity in the context of the resolution of an entity, depositors should not be insured beyond the coverage level provided for in Directive 2014/49/EU. Therefore, claims with regard to deposits remaining in the institution under resolution should be limited to the difference between the funds transferred and the coverage level provided for in Directive 2014/49/EU. Where transferred deposits are superior to the coverage level, the depositor should have no claim against the deposit guarantee scheme with regard to deposits remaining in the institution under resolution. (83) To avoid entities structuring their liabilities in a manner that impedes the effectiveness of the bail-in tool, it is appropriate to establish that the entities should meet at all times a minimum requirement for own funds and eligible liabilities which may be subject to the bail-in tool, expressed as a percentage of the total liabilities and own funds of the entity. (84) A top-down approach should be adopted when determining the minimum requirement for own funds and eligible liabilities within a group. That approach should recognise that resolution action is applied at the level of the individual legal entity, and that it is imperative that loss absorbing capacity is located in, or is accessible to, the entity within the group where losses occur. To that end, it should be ensured that loss absorbing capacity within a group is distributed across the group in accordance with the level of risk in its constituent legal entities. The minimum requirement for own funds and eligible liabilities necessary for each individual subsidiary should be separately assessed. Furthermore, it should be ensured that all capital and liabilities which are counted towards the consolidated minimum requirement for own funds and eligible liabilities are located in entities where losses are likely to occur, or are otherwise available to absorb losses. This Regulation should allow for a multiple-point-of-entry or a single-point-of-entry resolution. The minimum requirement for own funds and eligible liabilities should reflect the resolution strategy which is appropriate to a group in accordance with the resolution plan. In particular, the minimum requirement for own funds and eligible liabilities should be required at the appropriate level in the group in order to reflect a multiple-point-of-entry or a single-point-of-entry approach contained in the resolution plan while keeping in mind that there could be circumstances where an approach different from that contained in the plan is used as it would allow, for instance, reaching the resolution objectives more efficiently. Against that background, regardless of whether a group has chosen the multiple-point-of entry or the single-point-of-entry approach, all entities of the group should have at any time a robust minimum requirement for own funds and eligible liabilities so as to avoid the risk of contagion or of a bank run. (85) The best method of resolution should be chosen depending on the circumstances of the case and, for that purpose, all of the resolution tools provided for in Directive 2014/59/EU should be available. When deciding on the resolution scheme, the Board, the Council and the Commission should, to the extent possible, respectively opt for the scheme that is the least costly for the Fund. (86) Directive 2014/59/EU confers power on the national resolution authorities to write down and convert capital instruments, since the conditions for the write-down and conversion of capital instruments may coincide with the conditions for resolution and in such a case, an assessment is to be made of whether the sole write-down and conversion of the capital instruments is sufficient to restore the financial soundness of the entity concerned or whether it is also necessary to take resolution action. As a rule, it will be used in the context of resolution. The Board, under the control of the Commission or, where relevant, of the Council, should replace the national resolution authorities also in that function and should therefore be empowered to assess whether the conditions for the write-down and conversion of capital instruments are met and to decide whether to place an entity under resolution, if the requirements for resolution are also fulfilled. (87) The efficiency and uniformity of resolution action should be ensured in all of the participating Member States. For that purpose, where a national resolution authority has not applied or has not complied with a decision by the Board pursuant to this Regulation or has applied it in a way which poses a threat to any of the resolution objectives or to the efficient implementation of the resolution scheme, the Board should be empowered to transfer to another person specified rights, assets or liabilities of an institution under resolution, to require the conversion of debt instruments which contain a contractual term for conversion in certain circumstances or to adopt any necessary action which significantly addresses the threat to the relevant resolution objective. Any action by a national resolution authority that would restrain or affect the exercise of powers or functions of the Board should be excluded. (88) The relevant entities, bodies and authorities involved in the application of this Regulation should cooperate with each other in accordance with the duty of sincere cooperation enshrined in the Treaties. (89) In order to enhance the effectiveness of the SRM, the Board should closely cooperate with EBA in all circumstances. Where appropriate the Board should also cooperate with the ESRB, the European Supervisory Authority (European Insurance and Occupational Pensions Authority) (‘EIOPA’) established by Regulation (EU) No 1094/2010 of the European Parliament and of the Council (11), the European Supervisory Authority (European Securities and Markets Authority) (‘ESMA’), established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council (12), and the other authorities which constitute the ESFS. Moreover, the Board should closely cooperate with the ECB and the other authorities empowered to supervise entities within the SSM, in particular for groups subject to the consolidated supervision by the ECB. To effectively manage the resolution process of failing banks, the Board should cooperate with the national resolution authorities at all stages of the resolution process. Thus, that cooperation is necessary not only for the implementation of resolution decisions taken by the Board, but also prior to the adoption of any resolution decision, at the stage of resolution planning or during the phase of early intervention. The Board should be able to cooperate with relevant resolution authorities and facilities financing direct or indirect public financial assistance. (90) When applying resolution tools and exercising resolution powers, the Board should instruct the national resolution authorities to ensure that the representatives of the employees of the entities concerned are informed and, where appropriate, are consulted, as provided for in Directive 2014/59/EU. (91) Since the Board replaces the national resolution authorities of the participating Member States in their resolution decisions, the Board should also replace those authorities for the purposes of the cooperation with non-participating Member States, including in the resolution colleges as referred to in Directive 2014/59/EU as far as the resolution functions are concerned. (92) As many institutions operate not only within the Union, but internationally, an effective resolution mechanism needs to set out principles of cooperation with the relevant third-country authorities. Support to third-country authorities should be provided in accordance with the legal framework provided for in Article 88 of Directive 2014/59/EU. In order to ensure a coherent approach vis-à-vis third countries, the taking of divergent decisions in the participating Member States with respect to the recognition of resolution proceedings conducted in third countries in relation to institutions or parent undertakings which have subsidiaries or other assets, rights or liabilities located in the participating Member States should be avoided as far as possible. The Board should therefore be enabled to issue recommendations in that regard. (93) In order to perform its tasks effectively, the Board should have appropriate investigatory powers. It should be able to require all necessary information either through the national resolution authorities, or directly, after informing them, and to conduct investigations and on-site inspections, where appropriate in cooperation with national competent authorities, making full use of all information available to the ECB and the national competent authorities. In the context of resolution, on-site inspections should be available for the Board to ensure that decisions are taken on the basis of fully accurate information and to monitor implementation by national authorities effectively. (94) In order to ensure that the Board has access to all relevant information, the relevant entities and their employees or third parties to whom the entities concerned have outsourced functions or activities should not be able to invoke the requirements of professional secrecy to prevent the disclosure of information to the Board. At the same time, the disclosure of such information to the Board should not be deemed to infringe the requirements of professional secrecy. (95) In order to ensure compliance with decisions adopted within the framework of the SRM, proportionate and dissuasive fines should be imposed in the event of an infringement. The Board should be entitled to impose fines or periodic penalty payments on undertakings for failure to comply with its decisions addressed to them. (96) Where a national resolution authority infringes the rules of the SRM by not using the powers conferred on it under national law to implement an instruction by the Board, the Member State concerned may be liable to make good any damage caused to individuals, including, where applicable, to the institution or group under resolution, or any creditor of any part of that entity or group in any Member State, in accordance with the relevant case-law. (97) In order to guarantee its full autonomy and independence, the Board should have an autonomous budget with revenues from obligatory contributions from the institutions in the participating Member States. Appropriate rules should be laid down governing the budget of the Board, the preparation of the budget, the adoption of internal rules specifying the procedure for the establishment and implementation of the budget, and the internal and external audit of the accounts. (98) This Regulation should be without prejudice to the ability of Member States to levy fees to cover the administrative expenses of their national resolution authorities. (99) Participating Member States have jointly agreed to ensure that non-participating Member States are to be reimbursed promptly and with interest for the amount that a non-participating Member State has paid in own resources in respect of any application of the Union budget for the purposes of meeting non-contractual liabilities and costs relating thereto in relation to the performance of tasks under this Regulation. Participating Member States have concluded an agreement to implement that commitment. (100) There are circumstances in which the effectiveness of the resolution tools applied may depend on the availability of short-term funding for the entity or a bridge entity, the provision of guarantees to potential purchasers, or the provision of capital to the bridge entity. Notwithstanding the role of central banks in providing liquidity to the financial system even in times of stress, it is therefore important to set up a fund to avoid that the funds needed for such purposes come from the national budgets. It should be the financial industry, as a whole, that finances the stabilisation of the financial system. (101) It is necessary to ensure that the Fund is fully available for the purpose of the resolution of failing institutions. Therefore, the Fund should not be used for any other purpose than the efficient implementation of resolution tools and resolution powers. Furthermore, it should be used only in accordance with the applicable resolution objectives and principles. Accordingly, the Board should ensure that any losses, costs or other expenses incurred in connection with the use of the resolution tools are first borne by the shareholders and the creditors of the institution under resolution. Only where the resources from shareholders and creditors are exhausted should the losses, costs or other expenses incurred with the resolution tools be borne by the Fund. (102) As a principle, contributions should be collected from the industry prior to, and independently of, any operation of resolution. When prior funding is insufficient to cover the losses or costs incurred by the use of the Fund, additional contributions should be collected to bear the additional cost or loss. Moreover, the Fund should be able to contract borrowings or other forms of support from institutions, financial institutions or other third parties in the event that the ex-ante and ex-post contributions are not immediately accessible or do not cover the expenses incurred by the use of the Fund in relation to resolution actions. (103) In order to avoid double payments, Member States should be able to make use of available financial means resulting from national bank levies, taxes or resolution contributions established between 17 June 2010 and 2 July 2014 for the purpose of the ex-ante contributions. (104) In order to reach a critical mass and to avoid pro-cyclical effects which would arise if the Fund had to rely solely on ex-post contributions in a systemic crisis, it is indispensable that the ex-ante available financial means of the Fund amount at least to a certain minimum target level. (105) The target level of the Fund should be established as a percentage of the amount of covered deposits of all credit institutions authorised in the participating Member States. However, since the amount of the total liabilities of those institutions would be, taking into account the functions of the Fund, a more adequate benchmark, the Commission should assess whether covered deposits or total liabilities is a more appropriate basis and if a minimum absolute amount for the Fund should be introduced in the future, maintaining a level playing field with Directive 2014/59/EU. (106) An appropriate time frame should be set to reach the target level for the Fund. However, it should be possible for the Board to adjust the contribution period to take into account significant disbursements made from the Fund. (107) Ensuring effective and sufficient financing of the Fund is of paramount importance to the credibility of the SRM. The capacity of the Board to contract alternative funding means for the Fund should be enhanced in a manner that optimises the cost of funding and preserves the creditworthiness of the Fund. Immediately after the entry into force of this Regulation, the necessary steps should be taken by the Board in cooperation with the participating Member States to develop the appropriate methods and modalities permitting the enhancement of the borrowing capacity of the Fund that should be in place by the date of application of this Regulation. (108) Where participating Member States have already established national resolution financing arrangements, they should be able to provide that the national resolution financing arrangements use their available financial means, collected from entities in the past by way of ex-ante contributions, to compensate entities for the ex-ante contributions which those entities should pay into the Fund. Such restitution should be without prejudice to the obligations of Member States under Directive 2014/49/EU. (109) In order to ensure a fair calculation of contributions and provide incentives to operate under a model which presents less risk, contributions to the Fund should take account of the degree of risk incurred by the credit institution in accordance with Directive 2014/59/EU and with the delegated acts adopted pursuant thereto. (110) In order to ensure the proper sharing of resolution costs between deposit guarantee schemes and the Fund, the deposit guarantee scheme to which an institution under resolution is affiliated should be required to make a contribution not greater than the amount of losses that it would have had to bear if the entity had been wound up under normal insolvency proceedings. (111) So as to protect the value of the amounts held in the Fund, those amounts should be invested in sufficiently safe, diversified and liquid assets. (112) Where close cooperation of a participating Member State whose currency is not the euro with the ECB is terminated in accordance with Article 7 of Regulation (EU) No 1024/2013, a fair partition of the cumulated contributions of the participating Member State concerned should be decided taking into account the interests of the participating Member State concerned and the Fund. (113) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to determine the rules for the calculation of the interest rate to be applied in the event of a decision on the recovery of misused amounts from the Fund and to guarantee the rights to good administration and of access to documents of beneficiaries in procedures in respect of such a recovery; determine the type of contributions to the Fund and the matters for which contributions are due, and the manner in which the amount of the contributions is calculated and the way in which they are to be paid; specify registration, accounting, reporting and other rules necessary to ensure that the contributions are paid fully and in a timely manner; determine the annual contributions necessary to cover the administrative expenditure of the Board before it becomes fully operational; determine the contribution system for institutions that have been authorised to operate after the Fund has reached its target level; determine the criteria for the spreading out in time of the contributions; determine the criteria for determining the number of years by which the initial period for reaching the target level can be extended; determine the criteria for establishing the annual contributions when the available financial means of the Fund diminishes below its target level after the initial period; determine the measures to specify the circumstances and conditions under which ex-post contributions may be temporarily deferred for individual institutions; and determine the detailed rules for the administration of the Fund and general principles and criteria for its investment strategy. (114) The Council should, within the framework of the delegated acts adopted under Directive 2014/59/EU, adopt implementing acts to specify the application of the methodology for the calculation of individual contributions to the Fund, as well as the technical modalities for computing the flat contribution and the risk-adjusted contribution. That methodology should ensure that both the flat and the risk-adjusted elements in the formula for the calculation of individual contributions are accounted in a way that is consistent with resolution principles and in line with the delegated acts adopted pursuant to Article 103(7) of Directive 2014/59/EU. The methodology should take into account the principle of proportionality, without creating distortions between banking sector structures of the Member States. (115) As reflected in the Declaration No 39 on Article 290 of the TFEU, the Commission, in accordance with the established practice, in preparation of draft delegated acts provided for in this Regulation, should continue to consult experts appointed by the Member States. It is also of particular importance in this area that the Commission, where relevant, carry out appropriate consultations during its preparatory work with the ECB and the Board in their fields of competence. (116) Resolution actions should be properly notified and, subject to the limited exceptions laid down in this Regulation, made public. However, as information obtained by the Board, the national resolution authorities and their professional advisers during the resolution process is likely to be sensitive, before the resolution decision is made public, that information should be subject to the requirements of professional secrecy. The fact that information on the contents and details of resolution plans and the result of any assessment of those plans may have far-reaching effects, in particular on the undertakings concerned, must be taken into account. Any information provided in respect of a decision before it is taken, be it on whether the conditions for resolution are satisfied, on the use of a specific tool or of any action during the proceedings, must be presumed to have effects on the public and private interests concerned by the action. However, information that the Board and the national resolution authorities are examining a specific entity could be enough to have negative effects on that entity. It is therefore necessary to ensure that there are appropriate mechanisms for maintaining the confidentiality of such information, such as the content and details of resolution plans and the result of any assessment carried out in that context. (117) To preserve the confidentiality of the work of the Board, its members and its staff, including the staff exchanged with or seconded by participating Member States for the purpose of carrying out resolution duties, should be subject to requirements of professional secrecy, even after their duties have ceased. Those requirements should also apply to other persons authorised by the Board, to persons authorised or appointed by the national resolution authorities of the Member States to conduct on-site inspections, and to observers invited to attend the plenary and executive sessions' meetings of the Board and to observers from non-participating Member States that take part in internal resolution teams. For the purpose of performing the tasks conferred on it by this Regulation, the Board should be authorised, subject to conditions, to exchange information with national or Union authorities and bodies. (118) In order to ensure that the Board is assimilated in the ESFS, Regulation (EU) No 1093/2010 should be amended in order to include the Board in the concept of competent authorities established by that Regulation. Such assimilation of the Board and competent authorities pursuant to Regulation (EU) No 1093/2010 is consistent with the functions attributed to EBA pursuant to Article 25 of Regulation (EU) No 1093/2010 to contribute to and participate actively in the development and coordination of recovery and resolution plans and to aim to facilitate the resolution of failing entities and in particular cross-border groups. (119) Until the Board is fully operational, the Commission should be responsible for the initial operations including the designation of an interim Chair to authorise all necessary payments on behalf of the Board. (120) The SRM brings together the Board, the Council, the Commission and the resolution authorities of the participating Member States. The Court of Justice has jurisdiction to review the legality of decisions adopted by the Board, the Council and the Commission, in accordance with Article 263 TFEU, as well as for determining their non-contractual liability. Furthermore, the Court of Justice has, in accordance with Article 267 TFEU, competence to give preliminary rulings upon request of national judicial authorities on the validity and interpretation of acts of the institutions, bodies or agencies of the Union. National judicial authorities should be competent, in accordance with their national law, to review the legality of decisions adopted by the resolution authorities of the participating Member States in the exercise of the powers conferred on them by this Regulation, as well as to determine their non-contractual liability. (121) This Regulation respects the fundamental rights and observes the rights, freedoms and principles recognised in particular by the Charter, and, in particular, the right to property, the protection of personal data, the freedom to conduct a business, the right to an effective remedy and to a fair trial and the right of defence, and should be implemented in accordance with those rights and principles. (122) Since the objectives of this Regulation, namely setting up an efficient and effective single European framework for the resolution of entities and ensuring the consistent application of resolution rules, cannot be sufficiently achieved by the Member States but can rather be better achieved at the Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (123) The Commission should review the application of this Regulation in order to assess its impact on the internal market and to determine whether any modifications or further developments are needed in order to improve the efficiency and the effectiveness of the SRM, in particular whether the banking Union needs to be completed with the harmonisation at Union level of insolvency proceedings for failed institutions. (124) The transfer of contributions raised at national level under this Regulation should allow the Fund to operate and thus the resolution tools to be applied in an effective manner. Therefore, the provisions of this Regulation relating to resolution tools and the contributions should apply from 1 January 2016. From December 2015, it should be possible to postpone that date by periods of one month where the conditions allowing the transfer of the contributions raised at national level have not been met, HAVE ADOPTED THIS REGULATION: PART I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes uniform rules and a uniform procedure for the resolution of the entities referred to in Article 2 that are established in the participating Member States referred to in Article 4. Those uniform rules and that uniform procedure shall be applied by the Single Resolution Board established in accordance with Article 42 (the ‘Board’), together with the Council and the Commission and the national resolution authorities within the framework of the single resolution mechanism (‘SRM’) established by this Regulation. The SRM shall be supported by a single resolution fund (‘the Fund’). The use of the Fund shall be contingent upon the entry into force of an agreement among the participating Member States (‘the Agreement’) on transferring the funds raised at national level towards the Fund as well as on a progressive merger of the different funds raised at national level to be allocated to national compartments of the Fund. Article 2 Scope This Regulation shall apply to the following entities: (a) credit institutions established in a participating Member State; (b) parent undertakings, including financial holding companies and mixed financial holding companies, established in a participating Member State, where they are subject to consolidated supervision carried out by the ECB in accordance with Article 4(1)(g) of Regulation (EU) No 1024/2013; (c) investment firms and financial institutions established in a participating Member State, where they are covered by the consolidated supervision of the parent undertaking carried out by the ECB in accordance with Article 4(1)(g) of Regulation (EU) No 1024/2013. Article 3 Definitions 1. For the purposes of this Regulation the following definitions apply: (1) ‘national competent authority’ means any national competent authority as defined in Article 2(2) of Regulation (EU) No 1024/2013; (2) ‘competent authority’ means a competent authority as defined in Article 4(2)(i) of Regulation (EU) No 1093/2010; (3) ‘national resolution authority’ means an authority designated by a participating Member State in accordance with Article 3 of Directive 2014/59/EU; (4) ‘relevant national resolution authority’ means the national resolution authority of a participating Member State in which an entity or a group's entity is established; (5) ‘conditions for resolution’ means the conditions referred to in Article 18(1); (6) ‘resolution plan’ means a plan drawn up in accordance with Article 8 or 9; (7) ‘group resolution plan’ means a plan for group resolution drawn up in accordance with Articles 8 and 9; (8) ‘resolution objectives’ means the objectives referred to in Article 14; (9) ‘resolution tool’ means a resolution tool referred to in Article 22(2); (10) ‘resolution action’ means the decision to place an entity referred to in Article 2 under resolution pursuant to Article 18, the application of a resolution tool or the exercise of one or more resolution powers; (11) ‘covered deposits’ means deposits as defined in Article 2(1)(5) of Directive 2014/49/EU; (12) ‘eligible deposits’ means eligible deposits as defined in Article 2(1)(4) of Directive 2014/49/EU; (13) ‘institution’ means a credit institution, or an investment firm covered by consolidated supervision in accordance with Article 2(c); (14) ‘institution under resolution’ means an entity referred to in Article 2 in respect of which a resolution action is taken; (15) ‘financial institution’ means a financial institution as defined in Article 4(1)(26) of Regulation (EU) No 575/2013; (16) ‘financial holding company’ means a financial holding company as defined in Article 4(1)(20) of Regulation (EU) No 575/2013; (17) ‘mixed financial holding company’ means a mixed financial holding company as defined in point (21) of Article 4(1) of Regulation (EU) No 575/2013; (18) ‘Union parent financial holding company’ means an EU parent financial holding company as defined in point (31) of Article 4(1) of Regulation (EU) No 575/2013; (19) ‘Union parent institution’ means an EU parent institution as defined in point (29) of Article 4(1) of Regulation (EU) No 575/2013; (20) ‘parent undertaking’ means a parent undertaking as defined in Article 4(1)(15)(a) of Regulation (EU) No 575/2013; (21) ‘subsidiary’ means a subsidiary as defined in Article 4(1)(16) of Regulation (EU) No 575/2013; (22) ‘branch’ means a branch as defined in Article 4(1)(17) of Regulation (EU) No 575/2013; (23) ‘group’ means a parent undertaking and its subsidiaries that are entities as referred to in Article 2; (24) ‘cross-border group’ means a group that has entities as referred to in Article 2 established in more than one participating Member State; (25) ‘consolidated basis’ means the basis of the consolidated situation as defined in Article 4(1)(47) of Regulation (EU) No 575/2013; (26) ‘consolidating supervisor’ means consolidating supervisor as defined in Article 4(1)(41) of Regulation (EU) No 575/2013; (27) ‘group-level resolution authority’ means the resolution authority in the participating Member State in which the institution or parent undertaking subject to consolidated supervision at the highest level of consolidation within participating Member States in accordance with Article 111 of Directive 2013/36/EU is established; (28) ‘institutional protection scheme’ or ‘IPS’ means an arrangement that meets the requirements laid down in Article 113(7) of Regulation (EU) No 575/2013; (29) ‘extraordinary public financial support’ means State aid within the meaning of Article 107(1) TFEU or any other public financial support at supra-national level, which, if provided at national level, would constitute State aid, that is provided in order to preserve or restore the viability, liquidity or solvency of an entity referred to in Article 2 of this Regulation or of a group of which such an entity forms part; (30) ‘sale of business tool’ means the mechanism for effecting a transfer by a resolution authority of instruments of ownership issued by an institution under resolution, or assets, rights or liabilities of an institution under resolution, to a purchaser that is not a bridge institution, in accordance with Article 24; (31) ‘bridge institution tool’ means the mechanism for transferring instruments of ownership issued by an institution under resolution, or assets, rights or liabilities of an institution under resolution, to a bridge institution, in accordance with Article 25; (32) ‘asset separation tool’ means the mechanism for effecting a transfer of assets, rights or liabilities of an institution under resolution to an asset management vehicle in accordance with Article 26; (33) ‘bail-in tool’ means the mechanism for effecting the exercise of the write-down and conversion powers in relation to liabilities of an institution under resolution in accordance with Article 27; (34) ‘available financial means’ means the cash, deposits, assets and irrevocable payment commitments available to the Fund for the purposes listed under Article 76(1); (35) ‘target level’ means the amount of available financial means to be reached under Article 69(1); (36) ‘Agreement’ means the agreement on the transfer and mutualisation of contributions to the Fund; (37) ‘transitional period’ means the period from the date of application of this Regulation as determined under Article 99(2) and (6) until the Fund reaches the target level or 1 January 2024, whichever is earlier; (38) ‘financial instrument’ means financial instrument as defined in point (50) of Article 4(1) of Regulation (EU) No 575/2013; (39) ‘debt instruments’ means bonds and other forms of transferable debt, instruments creating or acknowledging a debt, and instruments giving rights to acquire debt instruments; (40) ‘own funds’ means own funds as defined in Article 4(1)(118) of Regulation (EU) No 575/2013; (41) ‘own funds requirements’ means the requirements laid down in Articles 92 to 98 of Regulation (EU) No 575/2013; (42) ‘winding up’ means the realisation of assets of an entity referred to in Article 2; (43) ‘derivative’ means a derivative as defined in Article 2(5) of Regulation (EU) No 648/2012; (44) ‘write-down and conversion powers’ means the powers referred to in Article 21; (45) ‘Common Equity Tier 1 instruments’ means capital instruments that meet the conditions laid down in Article 28(1) to (4), Article 29(1) to (5) or Article 31(1) of Regulation (EU) No 575/2013; (46) ‘Additional Tier 1 instruments’ means capital instruments that meet the conditions laid down in Article 52(1) of Regulation (EU) No 575/2013; (47) ‘Tier 2 instruments’ means capital instruments or subordinated loans that meet the conditions laid down in Article 63 of Regulation (EU) No 575/2013; (48) ‘aggregate amount’ means the aggregate amount by which the resolution authority has assessed that eligible liabilities are to be written down or converted, in accordance with Article 27(13); (49) ‘eligible liabilities’ means the liabilities and capital instruments that do not qualify as Common Equity Tier 1, Additional Tier 1 or Tier 2 instruments of an entity referred to in Article 2 that are not excluded from the scope of the bail-in tool pursuant to Article 27(3); (50) ‘deposit guarantee scheme’ means a deposit guarantee scheme introduced and officially recognised by a Member State pursuant to Article 4 of Directive 2014/49/EU; (51) ‘relevant capital instruments’ means Additional Tier 1 instruments and Tier 2 instruments; (52) ‘covered bond’ means an instrument as referred to in Article 52(4) of Directive 2009/65/EC of the European Parliament and of the Council (13); (53) ‘depositor’ means a depositor as defined in Article 2(1)(6) of Directive 2014/49/EU; (54) ‘investor’ means an investor within the meaning of Article 1(4) of Directive 97/9/EC of the European Parliament and of the Council (14). 2. In the absence of a relevant definition in paragraph 1 of this Article, the definitions referred to in Article 2 of Directive 2014/59/EU apply. In the absence of a relevant definition in paragraph 1 of this Article or in Article 2 of Directive 2014/59/EU, the definitions referred to in Article 3 of Directive 2013/36/EU apply. Article 4 Participating Member States 1. Participating Member States within the meaning of Article 2 of Regulation (EU) No 1024/2013 shall be considered to be participating Member States for the purposes of this Regulation. 2. Where close cooperation between a Member State and the ECB is suspended or terminated in accordance with Article 7 of Regulation (EU) No 1024/2013, entities established in that Member State shall cease to be covered by this Regulation from the date of application of the decision to suspend or terminate close cooperation. 3. In the event that the close cooperation with the ECB of a Member State whose currency is not the euro is terminated in accordance with Article 7 of Regulation (EU) No 1024/2013, the Board shall decide within three months after the date of adoption of the decision to terminate close cooperation, in agreement with that Member State, on the modalities for the recoupment of contributions that the Member State concerned has transferred to the Fund and any conditions applicable. Recoupments shall include the part of the compartment corresponding to the Member State concerned not subject to mutualisation. If during the transitional period, as laid down in the Agreement, recoupments of the non-mutualised part are not sufficient to permit the funding of the establishment by the Member State concerned of its national financial arrangement in accordance with Directive 2014/59/EU, recoupments shall also include the totality or a part of the part of the compartment corresponding to that Member State subject to mutualisation in accordance with the Agreement or otherwise, after the transitional period, the totality or a part of the contributions transferred by the Member State concerned during the close cooperation, in an amount sufficient to permit the funding of that national financial arrangement. When assessing the amount of financial means to be recouped from the mutualised part or otherwise, after the transitional period, from the Fund, the following additional criteria shall be taken into account: (a) the manner in which termination of close cooperation with the ECB has taken place, whether voluntarily, in accordance with Article 7(6) of Regulation (EU) No 1024/2013, or not; (b) the existence of ongoing resolution actions on the date of termination; (c) the economic cycle of the Member State concerned by the termination. Recoupments shall be distributed during a limited period commensurate to the duration of the close cooperation. The relevant Member State's share of the financial means from the Fund used for resolution actions during the period of close cooperation shall be deducted from those recoupments. 4. This Regulation shall continue to apply to resolution proceedings which are ongoing on the date of application of a decision as referred to in paragraph 2. Article 5 Relation to Directive 2014/59/EU and applicable national law 1. Where, pursuant to this Regulation, the Board performs tasks and exercises powers, which, pursuant to Directive 2014/59/EU are to be performed or exercised by the national resolution authority, the Board shall, for the application of this Regulation and of Directive 2014/59/EU, be considered to be the relevant national resolution authority or, in the event of cross-border group resolution, the relevant group-level resolution authority. 2. The Board, the Council and the Commission and, where relevant, the national resolution authorities, shall take decisions subject to and in compliance with the relevant Union law and in particular any legislative and non-legislative acts, including those referred to in Articles 290 and 291 TFEU. The Board, the Council and the Commission shall be subject to binding regulatory and implementing technical standards developed by EBA and adopted by the Commission in accordance with Articles 10 to 15 of Regulation (EU) No 1093/2010 and to any guidelines and recommendations issued by EBA under Article 16 of that Regulation. They shall make every effort to comply with any guidelines and recommendations of EBA which relate to tasks of a kind to be performed by those bodies. Where they do not comply or do not intend to comply with such guidelines or recommendations EBA shall be informed thereof in accordance with Article 16(3) of that Regulation. The Board, the Council and the Commission shall cooperate with EBA in the application of Articles 25 and 30 of that Regulation. The Board shall also be subject to any decisions of EBA in accordance with Article 19 of Regulation (EU) No 1093/2010 where Directive 2014/59/EU provides for such decisions. Article 6 General principles 1. No action, proposal or policy of the Board, the Council, the Commission or a national resolution authority shall discriminate against entities, deposit holders, investors or other creditors established in the Union on grounds of their nationality or place of business. 2. Every action, proposal or policy of the Board, the Council, the Commission, or of a national resolution authority in the framework of the SRM shall be undertaken with full regard and duty of care for the unity and integrity of the internal market. 3. When making decisions or taking action which may have an impact in more than one Member State, and in particular when taking decisions concerning groups established in two or more Member States, due consideration shall be given to the resolution objectives referred to in Article 14 and all of the following factors: (a) the interests of the Member States where a group operates and in particular the impact of any decision or action or inaction on the financial stability, fiscal resources, the economy, the financing arrangements, the deposit guarantee scheme or the investor compensation scheme of any of those Member States and on the Fund; (b) the objective of balancing the interests of the various Member States involved and of avoiding unfairly prejudicing or unfairly protecting the interests of a Member State; (c) the need to minimise a negative impact for any part of a group of which an entity referred to in Article 2, which is subject to a resolution, is a member. 4. When making decisions or taking actions, in particular regarding entities or groups established both in a participating Member State and in a non-participating Member State, possible negative effects on non-participating Member States, including on entities established in those Member States, shall be taken into consideration. 5. The Board, the Council and the Commission shall balance the factors referred to in paragraph 3 with the resolution objectives referred to in Article 14 as appropriate to the nature and circumstances of each case and shall comply with the decisions made by the Commission under Article 107 TFEU and Article 19 of this Regulation. 6. Decisions or actions of the Board, the Council or the Commission shall neither require Member States to provide extraordinary public financial support nor impinge on the budgetary sovereignty and fiscal responsibilities of the Member States. 7. Where the Board takes a decision that is addressed to a national resolution authority, the national resolution authority shall have the right to specify further the measures to be taken. Such specifications shall comply with the decision of the Board in question. Article 7 Division of tasks within the SRM 1. The Board shall be responsible for the effective and consistent functioning of the SRM. 2. Subject to the provisions referred to in Article 31(1), the Board shall be responsible for drawing up the resolution plans and adopting all decisions relating to resolution for: (a) the entities referred to in Article 2 that are not part of a group and for groups: (i) which are considered to be significant in accordance with Article 6(4) of Regulation (EU) No 1024/2013; or (ii) in relation to which the ECB has decided in accordance with Article 6(5)(b) of Regulation (EU) No 1024/2013 to exercise directly all of the relevant powers; and (b) other cross-border groups. 3. In relation to entities and groups other than those referred to in paragraph 2, without prejudice to the responsibilities of the Board for the tasks conferred on it by this Regulation, the national resolution authorities shall perform, and be responsible for, the following tasks: (a) adopting resolution plans and carrying out an assessment of resolvability in accordance with Articles 8 and 10 and with the procedure laid down in Article 9; (b) adopting measures during early intervention in accordance with Article 13(3); (c) applying simplified obligations or waiving the obligation to draft a resolution plan, in accordance with Article 11; (d) setting the level of minimum requirement for own funds and eligible liabilities, in accordance with Article 12; (e) adopting resolution decisions and applying resolution tools referred to in this Regulation, in accordance with the relevant procedures and safeguards, provided that the resolution action does not require any use of the Fund and is financed exclusively by the tools referred to in Articles 21 and 24 to 27 and/or by the deposit guarantee scheme, in accordance with Article 79, and with the procedure laid down in Article 31; (f) writing down or converting relevant capital instruments pursuant to Article 21, in accordance with the procedure laid down in Article 31. If the resolution action requires the use of the Fund, the Board shall adopt the resolution scheme. When adopting a resolution decision, the national resolution authorities shall take into account and follow the resolution plan as referred to in Article 9, unless they assess, taking into account the circumstances of the case, that the resolution objectives will be achieved more effectively by taking actions which are not provided for in the resolution plan. When performing the tasks referred to in this paragraph, the national resolution authorities shall apply the relevant provisions of this Regulation. Any references to the Board in Article 5(2), Article 6(5), Article 8(6), (8), (12) and (13), Article 10(1) to (10), Articles 11 to 14, Article 15(1), (2) and (3), Article 16, the first subparagraph of Article 18(1), Article 18(2) and (6), Article 20, Article 21(1) to (7), the second subparagraph of Article 21(8), Article 21(9) and (10), Article 22(1), (3) and (6), Articles 23 and 24, Article 25(3), Article 27(1) to (15), the second sentence of the second subparagraph, the third subparagraph, and the first, third and fourth sentences of the fourth subparagraph of Article 27(16), and Article 32 shall be read as references to the national resolution authorities with regard to groups and entities referred to in the first subparagraph of this paragraph. For that purpose the national resolution authorities shall exercise the powers conferred on them under national law transposing Directive 2014/59/EU in accordance with the conditions laid down in national law. The national resolution authorities shall inform the Board of the measures referred to in this paragraph that are to be taken and shall closely coordinate with the Board when taking those measures. The national resolution authorities shall submit to the Board the resolution plans referred to in Article 9, as well as any updates, accompanied by a reasoned assessment of the resolvability of the entity or group concerned in accordance with Article 10. 4. Where necessary to ensure the consistent application of high resolution standards under this Regulation, the Board may: (a) further to the notification by a national resolution authority of a measure under paragraph 3 of this Article pursuant to Article 31(1), within the appropriate timeframe having regard to the urgency of the circumstances, issue a warning to the relevant national resolution authority where the Board considers that the draft decision with regard to any entity or group referred to in paragraph 3 of this Article does not comply with this Regulation or with its general instructions referred to in Article 31(1)(a); (b) at any time decide, in particular if its warning referred to in point (a) is not being appropriately addressed, on its own initiative, after consulting the national resolution authority concerned, or upon request from the national resolution authority concerned, to exercise directly all of the relevant powers under this Regulation also with regard to any entity or group referred to in paragraph 3 of this Article. 5. Notwithstanding paragraph 3 of this Article, participating Member States may decide that the Board exercise all of the relevant powers and responsibilities conferred on it by this Regulation in relation to entities and to groups, other than those referred to in paragraph 2, established in their territory. If so, paragraphs 3 and 4 of this Article, Article 9, Article 12(2), and Article 31(1) shall not apply. Member States that intend to make use of this option shall notify the Board and the Commission accordingly. The notification shall take effect from the day of its publication in the Official Journal of the European Union. PART II SPECIFIC PROVISIONS TITLE I FUNCTIONS WITHIN THE SRM AND PROCEDURAL RULES CHAPTER 1 Resolution planning Article 8 Resolution plans drawn up by the Board 1. The Board shall draw up and adopt resolution plans for the entities and groups referred to in Article 7(2), and for the entities and groups referred to in Article 7(4)(b) and (5) where the conditions for the application of those paragraphs are met. 2. The Board shall draw up the resolution plans, after consulting the ECB or the relevant national competent authorities and the national resolution authorities, including the group-level resolution authority, of the participating Member States in which the entities are established, and the resolution authorities of non-participating Member States in which significant branches are located insofar as relevant to the significant branch. To that end, the Board may require the national resolution authorities to prepare and submit to the Board draft resolution plans and the group-level resolution authority to prepare and submit to the Board a draft group resolution plan. 3. In order to ensure effective and consistent application of this Article, the Board shall issue guidelines and address instructions to the national resolution authorities for the preparation of draft resolution plans and draft group resolution plans relating to specific entities or groups. 4. For the purposes of paragraph 1 of this Article, the national resolution authorities shall submit to the Board all information necessary to draw up and implement the resolution plans, as obtained by them in accordance with Article 11 and Article 13(1) of Directive 2014/59/EU, without prejudice to Chapter 5 of this Title. 5. The resolution plan shall set out options for applying the resolution tools and exercising resolution powers referred to in this Regulation to the entities and groups referred to in paragraph 1. 6. The resolution plan shall provide for the resolution actions which the Board may take where an entity or a group referred to in paragraph 1 meets the conditions for resolution. The information referred to in paragraph 9 shall be disclosed to the entity concerned. When drawing up and updating the resolution plan, the Board shall identify any material impediments to resolvability and, where necessary and proportionate, outline relevant actions for how those impediments could be addressed, in accordance with Article 10. The resolution plan shall take into consideration relevant scenarios including that the event of failure may be idiosyncratic or may occur at a time of broader financial instability or system wide events. The resolution plan shall not assume any of the following: (a) any extraordinary public financial support besides the use of the Fund established in accordance with Article 67; (b) any central bank emergency liquidity assistance; or (c) any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms. 7. The resolution plan shall include an analysis of how and when an institution may apply, in the conditions addressed by the plan, for the use of central bank facilities and shall identify those assets which would be expected to qualify as collateral. 8. The Board may require institutions to assist it in the drawing up and updating of the plans. 9. The resolution plan for each entity shall include, quantified where appropriate and possible: (a) a summary of the key elements of the plan; (b) a summary of the material changes to the institution that have occurred after the latest resolution information was filed; (c) a demonstration of how critical functions and core business lines could be legally and economically separated, to the extent necessary, from other functions so as to ensure continuity upon the failure of the institution; (d) an estimation of the timeframe for executing each material aspect of the plan; (e) a detailed description of the assessment of resolvability carried out in accordance with Article 10; (f) a description of any measures required pursuant to Article 10(7) to address or remove impediments to resolvability identified as a result of the assessment carried out in accordance with Article 10; (g) a description of the processes for determining the value and marketability of the critical functions, core business lines and assets of the institution; (h) a detailed description of the arrangements for ensuring that the information required pursuant to Article 11 of Directive 2014/59/EU is up to date and at the disposal of the resolution authorities at all times; (i) an explanation as to how the resolution options could be financed without the assumption of any of the following: (i) any extraordinary public financial support besides the use of the Fund established in accordance with Article 67; (ii) any central bank emergency liquidity assistance; or (iii) any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms; (j) a detailed description of the different resolution strategies that could be applied according to the different possible scenarios and the applicable timescales; (k) a description of critical interdependencies; (l) a description of options for preserving access to payments and clearing services and other infrastructures and an assessment of the portability of client positions; (m) an analysis of the impact of the plan on the employees of the institution, including an assessment of any associated costs, and a description of envisaged procedures to consult staff during the resolution process, taking into account national systems for dialogue with social partners, where applicable; (n) a plan for communicating with the media and the public; (o) the minimum requirement for own funds and eligible liabilities required pursuant to Article 12 and a deadline to reach that level, where applicable; (p) where applicable, the minimum requirement for own funds and contractual bail-in instruments pursuant to Article 12, and a deadline to reach that level, where applicable; (q) a description of essential operations and systems for maintaining the continuous functioning of the institution's operational processes; (r) where applicable, any opinion expressed by the institution in relation to the resolution plan. 10. Group resolution plans shall include a plan for the resolution of the group, headed by the Union parent undertaking established in a participating Member State, as a whole, either through resolution at the level of the Union parent undertaking or through break up and resolution of the subsidiaries. The group resolution plan shall identify measures for the resolution of: (a) the Union parent undertaking; (b) the subsidiaries that are part of the group and that are established in the Union; (c) the entities referred to in Article 2(b); and (d) subject to Article 33, the subsidiaries that are part of the group and that are established outside the Union. 11. The group resolution plan shall: (a) set out the resolution actions to be taken in relation to group entities, both through resolution actions in respect of the entities referred to in Article 2(b) and subsidiary institutions and through coordinated resolution actions in respect of subsidiary institutions, in the scenarios provided for in paragraph 6; (b) examine the extent to which the resolution tools and powers could be applied and exercised in a coordinated way to group entities established in the Union, including measures to facilitate the purchase by a third party of the group as a whole, or separate business lines or activities that are delivered by a number of group entities, or particular group entities, and identify any potential impediments to a coordinated resolution; (c) include a detailed description of the assessment of resolvability carried out in accordance with Article 10; (d) where a group includes entities incorporated in third countries, identify appropriate arrangements for cooperation and coordination with the relevant authorities of those third countries and the implications for resolution within the Union; (e) identify measures, including the legal and economic separation of particular functions or business lines, that are necessary to facilitate group resolution where the conditions for resolution are met; (f) identify how the group resolution actions could be financed and, where the Fund and the financing arrangements from non-participating Member States established in accordance with Article 100 of Directive 2014/59/EU would be required, set out principles for sharing responsibility for that financing between sources of funding in different participating and non-participating Member States. The plan shall not assume any of the following: (i) any extraordinary public financial support besides the use of the Fund established in accordance with Article 67 of this Regulation and the financing arrangements from non-participating Member States established in accordance with Article 100 of Directive 2014/59/EU; (ii) any central bank emergency liquidity assistance; or (iii) any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms. Those principles shall be set out on the basis of equitable and balanced criteria and shall take into account in particular Article 107(5) of Directive 2014/59/EU and the impact on financial stability in all Member States concerned. The group resolution plan shall not have a disproportionate impact on any Member State. 12. The Board shall determine the date by which the first resolution plans shall be drawn up. Resolution plans and group resolution plans shall be reviewed, and where appropriate updated, at least annually and after any material changes to the legal or organisational structure or to the business or the financial position of the entity or, in the case of group resolution plans, of the group including any group entity that could have a material effect on the effectiveness of the plan or that otherwise necessitates a revision of the resolution plan. For the purpose of the revision or update of the resolution plans referred to in the first subparagraph, the institutions, the ECB or the national competent authorities shall promptly communicate to the Board any change that necessitates such revision or update. 13. The Board shall transmit the resolution plans and any changes thereto to the ECB or to the relevant national competent authorities. Article 9 Resolution plans drawn up by national resolution authorities 1. The national resolution authorities shall draw up and adopt resolution plans for the entities and for the groups, other than those referred to in Article 7(2), (4)(b) and (5), in accordance with Article 8(5) to (13). 2. The national resolution authorities shall prepare resolution plans, after consulting the relevant national competent authorities and the national resolution authorities of the participating and non-participating Member States, in which significant branches are located, insofar as relevant to the significant branch. Article 10 Assessment of resolvability 1. When drafting and updating resolution plans in accordance with Article 8, the Board, after consulting the competent authorities, including the ECB, and the resolution authorities of non-participating Member States in which significant branches are located insofar as relevant to the significant branch, shall conduct an assessment of the extent to which institutions and groups are resolvable without the assumption of any of the following: (a) any extraordinary public financial support besides the use of the Fund established in accordance with Article 67; (b) any central bank emergency liquidity assistance; or (c) any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms. 2. The ECB or the relevant national competent authority shall provide the Board with a recovery plan or group recovery plan. The Board shall examine the recovery plan with a view to identifying any actions in the recovery plan which may adversely impact the resolvability of the institution or group and make recommendations to the ECB or the national competent authority on those matters. 3. When drafting a resolution plan, the Board shall assess the extent to which such an entity is resolvable in accordance with this Regulation. An entity shall be deemed to be resolvable if it is feasible and credible for the Board to either liquidate it under normal insolvency proceedings or to resolve it by applying to it resolution tools and exercising resolution powers while avoiding, to the maximum extent possible, any significant adverse consequences for financial systems, including circumstances of broader financial instability or system wide events, of the Member State in which the entity is situated, or other Member States, or the Union and with a view to ensuring the continuity of critical functions carried out by the entity. The Board shall notify EBA in a timely manner where an institution is deemed not to be resolvable. 4. A group shall be deemed to be resolvable if it is feasible and credible for the Board to either liquidate group entities under normal insolvency proceedings or to resolve them by applying resolution tools and exercising resolution powers in relation to group entities while avoiding, to the maximum extent possible, any significant adverse consequences for financial systems, including circumstances of broader financial instability or system wide events, of the Member States in which group entities are established, or other Member States or the Union and with a view to ensuring the continuity of critical functions carried out by those group entities, where they can be easily separated in a timely manner or by other means. The Board shall notify EBA in a timely manner where a group is deemed not to be resolvable. 5. For the purposes of paragraphs 3, 4 and 10, significant adverse consequences for the financial system or threat to financial stability refers to a situation where the financial system is actually or potentially exposed to a disruption that may give rise to financial distress liable to jeopardise the orderly functioning, efficiency and integrity of the internal market or the economy or the financial system of one or more Member States. In determining the significant adverse consequences the Board shall take into account the relevant warnings and recommendations of the ESRB and the relevant criteria developed by EBA in considering the identification and measurement of systemic risk. 6. For the purpose of the assessment referred to in this Article, the Board shall examine the matters specified in Section C of the Annex to Directive 2014/59/EU. 7. If, pursuant to an assessment of resolvability for an entity or a group carried out in accordance with paragraph 3 or 4, the Board, after consulting the competent authorities, including the ECB, determines that there are substantive impediments to the resolvability of that entity or group, the Board shall prepare a report, in cooperation with the competent authorities, addressed to the institution or the parent undertaking analysing the substantive impediments to the effective application of resolution tools and the exercise of resolution powers. That report shall consider the impact on the institution's business model and recommend any proportionate and targeted measures that, in the Board's view, are necessary or appropriate to remove those impediments in accordance with paragraph 10. 8. The report shall also be notified to the competent authorities and to the resolution authorities of non-participating Member States in which significant branches of institutions which are not part of a group are located. It shall be supported by reasons for the assessment or determination in question and shall indicate how that assessment or determination complies with the requirement for proportionate application laid down in Article 6. 9. Within four months from the date of receipt of the report, the entity or the parent undertaking shall propose to the Board possible measures to address or remove the substantive impediments identified in the report. The Board shall communicate any measure proposed by the entity or parent undertaking to the competent authorities, to EBA and, where significant branches of institutions that are not part of a group are located in non-participating Member States, to the resolution authorities of those Member States. 10. The Board, after consulting the competent authorities, shall assess whether the measures referred to in paragraph 9 effectively address or remove the substantive impediments in question. If the measures proposed by the entity or parent undertaking concerned do not effectively reduce or remove the impediments to resolvability, the Board shall take a decision, after consulting the competent authorities and, where appropriate, the designated macro-prudential authority, indicating that the measures proposed do not effectively reduce or remove the impediments to resolvability, and instructing the national resolution authorities to require the institution, the parent undertaking, or any subsidiary of the group concerned, to take any of the measures listed in paragraph 11. In identifying alternative measures, the Board shall demonstrate how the measures proposed by the institution would not be able to remove the impediments to resolvability and how the alternative measures proposed are proportionate in removing them. The Board shall take into account the threat to financial stability of those impediments to resolvability and the effect of the measures on the business of the institution, its stability and its ability to contribute to the economy, on the internal market for financial services and on the financial stability in other Member States and the Union as a whole. The Board shall also take into account the need to avoid any impact on the institution or the group concerned which would go beyond what is necessary to remove the impediment to resolvability or would be disproportionate. 11. For the purpose of paragraph 10, the Board, where applicable, shall instruct the national resolution authorities to take any of the following measures: (a) to require the entity to revise any intragroup financing agreements or review the absence thereof, or draw up service agreements (whether intra-group or with third parties) to cover the provision of critical functions; (b) to require the entity to limit its maximum individual and aggregate exposures; (c) to impose specific or regular additional information requirements relevant for resolution purposes; (d) to require the entity to divest specific assets; (e) to require the entity to limit or cease specific existing or proposed activities; (f) to restrict or prevent the development of new or existing business lines or sale of new or existing products; (g) to require changes to legal or operational structures of the entity or any group entity, either directly or indirectly under their control, so as to reduce complexity in order to ensure that critical functions may be legally and operationally separated from other functions through the application of the resolution tools; (h) to require an entity to set up a parent financial holding company in a Member State or a Union parent financial holding company; (i) to require an entity to issue eligible liabilities to meet the requirements of Article 12; (j) to require an entity to take other steps to meet the requirements referred to in Article 12, including in particular to attempt to renegotiate any eligible liability, Additional Tier 1 instrument or Tier 2 instrument it has issued, with a view to ensuring that any decision of the Board to write down or convert that liability or instrument would be effected under the law of the jurisdiction governing that liability or instrument. Where applicable, the national resolution authorities shall directly take the measures referred to in points (a) to (j) of the first subparagraph. 12. The national resolution authorities shall implement the instructions of the Board in accordance with Article 29. 13. A decision made pursuant to paragraphs 10 and 11 shall meet the following requirements: (a) it shall be supported by reasons for the assessment or determination in question; (b) it shall indicate how that assessment or determination complies with the requirement for proportionate application laid down in paragraph 10. Article 11 Simplified obligations for certain institutions 1. The Board, on its own initiative after consulting a national resolution authority or upon proposal by a national resolution authority, may apply simplified obligations in relation to the drafting of resolution plans referred to in Article 8 or may waive the obligation of drafting those plans in accordance with paragraphs 3 to 9 of this Article. 2. National resolution authorities may propose to the Board to apply simplified obligations to institutions or groups pursuant to paragraphs 3 and 4 or to waive the obligation of drafting resolution plans pursuant to paragraph 7. That proposal shall be reasoned and shall be supported by all of the relevant documentation. 3. On receiving a proposal to apply simplified obligations pursuant to paragraph 2 of this Article, or when acting on its own initiative, the Board shall conduct an assessment of the institution or group concerned and shall apply simplified obligations, if the failure of the institution or group is not likely to have significant adverse consequences for the financial system or be a threat to financial stability within the meaning of Article 10(5). For those purposes, the Board shall take into account: (a) the nature of the institution's or group's business, its shareholding structure, its legal form, its risk profile, size and legal status, its interconnectedness to other institutions or to the financial system in general, the scope and complexity of its activities; (b) its membership of an IPS or other cooperative mutual solidarity systems as referred to in Article 113(7) of Regulation (EU) No 575/2013; (c) any exercise of investment services or activities as defined in Article 4(1)(2) of Directive 2014/65/EU of the European Parliament and of the Council (15); and (d) whether its failure and subsequent winding up under normal insolvency proceedings would be likely to have a significant negative effect on financial markets, on other institutions, on funding conditions, or on the wider economy. The Board shall make the assessment referred to in the first subparagraph after consulting, where appropriate, the national macroprudential authority and, where appropriate, the ESRB. 4. When applying simplified obligations, the Board shall determine: (a) the contents and details of resolution plans provided for in Article 8; (b) the date by which the first resolution plans are to be drawn up and the frequency for updating resolution plans which may be lower than that provided for in Article 8(12); (c) the contents and details of the information required from institutions as provided for in Article 8(9) of this Regulation and in Section B of the Annex to Directive 2014/59/EU; (d) the level of detail for the assessment of resolvability provided for in Article 10 of this Regulation, and in Section C of the Annex to Directive 2014/59/EU. 5. The application of simplified obligations shall not in itself affect the Board's power to take any resolution action. 6. Where simplified obligations are applied, the Board shall impose full, unsimplified obligations at any time if any of the circumstances that justified them no longer exist. 7. Without prejudice to Articles 9 and 31, on receiving a proposal to waive the obligation of drafting resolution plans pursuant to paragraph 2 of this Article, or when acting on its own initiative, the Board shall, pursuant to paragraph 3 of this Article, waive the application of the obligation of drafting resolution plans to institutions affiliated to a central body and wholly or partially exempt from prudential requirements in national law in accordance with Article 10 of Regulation (EU) No 575/2013. Where a waiver is granted in accordance with the first subparagraph, the obligation of drafting the resolution plan shall apply on a consolidated basis to the central body and institutions affiliated to it within the meaning of Article 10 of Regulation (EU) No 575/2013. For that purpose, any reference in this Chapter to a group shall include a central body and institutions affiliated to it within the meaning of Article 10 of Regulation (EU) No 575/2013 and their subsidiaries, and any reference to parent undertakings or institutions that are subject to consolidated supervision pursuant to Article 111 of Directive 2013/36/EU shall include the central body. 8. Institutions that are subject to direct supervision by the ECB pursuant to Article 6(4) of Regulation (EU) No 1024/2013 or that constitute a significant share in the financial system of a participating Member State shall be the subject of individual resolution plans. For the purposes of this paragraph, the operations of an institution shall be considered to constitute a significant share of that participating Member State's financial system where: (a) the total value of its assets exceeds EUR 30 000 000 000; or (b) the ratio of its total assets over the GDP of the Member State of establishment exceeds 20 %, unless the total value of its assets is below EUR 5 000 000 000. 9. Where the national resolution authority which has proposed the application of simplified obligations or the grant of a waiver in accordance with paragraph 2 considers that the decision to apply simplified obligations or to grant the waiver must be withdrawn, it shall submit a proposal to the Board to that end. In that case, the Board shall take a decision on the proposed withdrawal taking full account of the justification for withdrawal put forward by the national resolution authority in the light of the factors or circumstances referred to in paragraph 3 or in paragraphs 7 and 8. 10. The Board shall inform EBA of its application of this Article. Article 12 Minimum requirement for own funds and eligible liabilities 1. The Board shall, after consulting competent authorities, including the ECB, determine the minimum requirement for own funds and eligible liabilities as referred to in paragraph 4, subject to write-down and conversion powers, which the entities and groups referred to in Article 7(2), and the entities and groups referred to in Article 7(4)(b) and (5) where the conditions for the application of these paragraphs are met, are required to meet at all times. 2. When drafting resolution plans in accordance with Article 9, national resolution authorities shall, after consulting competent authorities, determine the minimum requirement for own funds and eligible liabilities, as referred to in paragraph 4, subject to write-down and conversion powers, which the entities referred to in Article 7(3) are required to meet at all times. In that regard the procedure established in Article 31 shall apply. 3. In order to ensure effective and consistent application of this Article, the Board shall issue guidelines and address instructions to national resolution authorities relating to specific entities or groups. 4. The minimum requirement for own funds and eligible liabilities shall be calculated as the amount of own funds and eligible liabilities expressed as a percentage of the total liabilities and own funds of the institution. For the purpose of the first subparagraph derivative liabilities shall be included in the total liabilities on the basis that full recognition is given to counterparty netting rights. 5. Notwithstanding paragraph 1, the Board shall exempt mortgage credit institutions financed by covered bonds which, according to national law, are not allowed to receive deposits, from the obligation to meet, at all times, a minimum requirement for own funds and eligible liabilities, as: (a) those institutions will be wound up through national insolvency procedures, or other type of procedures implemented in accordance with Article 38, 40 or 42 of Directive 2014/59/EU, provided for those institutions; and (b) such national insolvency procedures, or other type of procedures, will ensure that creditors of those institutions, including holders of covered bonds where relevant, will bear losses in a way that meets the resolution objectives. 6. The minimum requirement for own funds and eligible liabilities referred to in paragraph 4 shall not exceed the amount of own funds and eligible liabilities sufficient to ensure that, if the bail-in tool were to be applied, the losses of an institution or a parent undertaking as referred to in Article 2, as well as of the ultimate parent undertaking of that institution or parent undertaking and any institution or financial institution included in the consolidated accounts of that ultimate parent undertaking, could be absorbed, and the Common Equity Tier 1 ratio of those entities could be restored to a level necessary to enable them to continue to comply with the conditions for authorisation and to continue to carry out the activities for which they are authorised under Directive 2013/36/EU or equivalent legislation and to sustain sufficient market confidence in the institution or parent undertaking referred to in Article 2 and the ultimate parent undertaking of that institution or parent undertaking and any institution or financial institution included in the consolidated accounts of that ultimate parent undertaking. Where the resolution plan anticipates that certain classes of eligible liabilities might be excluded from bail-in under Article 27(5), or that certain classes of eligible liabilities might be transferred to a recipient in full under a partial transfer, the minimum requirement for own funds and eligible liabilities referred to in paragraph 4 shall not exceed the amount of own funds and eligible liabilities necessary to ensure that the institution or parent undertaking referred to in Article 2 has sufficient other eligible liabilities to ensure that losses of the institution or the parent undertaking referred to in Article 2 as well as of the ultimate parent undertaking of that institution or parent undertaking and any institution or financial institution included in the consolidated accounts of that ultimate parent undertaking could be absorbed and the Common Equity Tier 1 ratio of those entities could be restored to a level necessary to enable them to continue to comply with the conditions for authorisation and to carry out the activities for which they are authorised under Directive 2013/36/EU or equivalent legislation and to sustain sufficient market confidence in the institution or parent undertaking and the ultimate parent undertaking of that institution or parent undertaking and any institution or financial institution included in the consolidated accounts of that ultimate parent undertaking. The minimum requirement for own funds and eligible liabilities referred to in paragraph 4 shall not be inferior to the total amount of any own funds requirements and buffer requirements under Regulation (EU) No 575/2013 and Directive 2013/36/EU. 7. Within the limits laid down in paragraph 6 of this Article, in order to ensure that an entity referred to in Article 2 can be resolved by the application of the resolution tools including, where appropriate, the bail-in tool, in a way that meets the resolution objectives, the determination referred to in paragraph 1 of this Article shall be made on the basis of the following criteria: (a) the size, the business model, the funding model and the risk profile of the institution and parent undertaking referred to in Article 2; (b) the extent to which the deposit guarantee scheme could contribute to the financing of resolution in accordance with Article 79; (c) the extent to which the failure of the institution and parent undertaking referred to in Article 2 would have significant adverse consequences for the financial system or would be a threat to financial stability within the meaning of Article 10(5), including, due to its interconnectedness with other institutions or with the rest of the financial system through contagion to other institutions. 8. The determination shall specify the minimum requirement for own funds and eligible liabilities that the institutions are to comply with on an individual basis, and that parent undertakings are to comply with on a consolidated basis. The minimum aggregate amount requirement for own funds and eligible liabilities at consolidated level of a Union parent undertaking established in a participating Member State shall be determined by the Board, after consulting the consolidating supervisor, on the basis of the criteria laid down in paragraph 7, and of whether the third-country subsidiaries of the group are to be resolved separately in accordance with the resolution plan. 9. The Board shall set the minimum requirement for own funds and eligible liabilities to be applied to the group's subsidiaries on an individual basis. Those minimum requirements for own funds and eligible liabilities shall be set at a level appropriate for the subsidiary having regard to: (a) the criteria listed in paragraph 7, in particular the size, business model and risk profile of the subsidiary, including its own funds; and (b) the consolidated requirement that has been set for the group. 10. The Board may decide to waive the minimum requirement for own funds and eligible liabilities on an individual basis to a parent institution provided that the conditions laid down in points (a) and (b) of Article 45(11) of Directive 2014/59/EU are met. The Board may decide to waive the minimum requirement for own funds and eligible liabilities on an individual basis to a subsidiary provided that the conditions laid down in points (a), (b) and (c) of Article 45(12) of Directive 2014/59/EU are met. 11. The Board, on its own initiative after consulting the national resolution authority or upon proposal by a national resolution authority, may decide that the minimum requirement for own funds and eligible liabilities as referred to in paragraph 1 is partially met on a consolidated or on an individual basis through contractual bail-in instruments, in full compliance with the criteria laid down in the first and second subparagraphs of paragraph 5 and in paragraph 7. 12. To qualify as a contractual bail-in instrument under paragraph 11, the Board must be satisfied that the instrument: (a) contains a contractual term providing that, where the Board decides that the bail-in tool be applied to that institution, the instrument shall be written down or converted to the extent required before other eligible liabilities are written down or converted; and (b) is subject to a binding subordination agreement, undertaking or provision under which in the event of normal insolvency proceedings, it ranks below other eligible liabilities and cannot be repaid until other eligible liabilities outstanding at the time have been settled. 13. The Board shall make any determination referred to in paragraph 1 of this Article, and, where relevant, in paragraph 11 of this Article, in parallel with the development and maintenance of the resolution plans pursuant to Article 8. 14. The Board shall address its determination to the national resolution authorities. The national resolution authorities shall implement the instructions of the Board in accordance with Article 29. The Board shall require that the national resolution authorities verify and ensure that institutions and parent undertakings maintain the minimum requirement for own funds and eligible liabilities laid down in paragraph 1 of this Article. 15. The Board shall inform the ECB and EBA of the minimum requirement for own funds and eligible liabilities that it has determined for each institution and parent undertaking under paragraph 1 and, where relevant, the requirements laid down in paragraph 11. 16. Eligible liabilities, including subordinated debt instruments and subordinated loans that do not qualify as Additional Tier 1 instruments or Tier 2 instruments, shall be included in the amount of own funds and eligible liabilities referred to in paragraph 1 only if they satisfy the following conditions: (a) the instrument is issued and fully paid up; (b) the liability is not owed to, secured by or guaranteed by the institution itself; (c) the purchase of the instrument was not funded either directly or indirectly by the institution; (d) the liability has a remaining maturity of at least one year; (e) the liability does not arise from a derivative; (f) the liability does not arise from a deposit which benefits from preference in the national insolvency hierarchy in accordance with Article 108 of Directive 2014/59/EU. For the purpose of point (d) of the first subparagraph, where a liability confers upon its owner a right to early reimbursement, the maturity of that liability shall be the first date where such right arises. 17. Where a liability is governed by the law of a jurisdiction outside the Union, the Board may instruct national resolution authorities to require the institution to demonstrate that any decision of the Board to write down or convert that liability would be effected under the law of that jurisdiction, having regard to the terms of the contract governing the liability, international agreements on the recognition of resolution proceedings and other relevant matters. If the Board is not satisfied that any decision would be effected under the law of that jurisdiction, the liability shall not be counted towards the minimum requirement for own funds and eligible liabilities. 18. If the Commission submits a legislative proposal pursuant to Article 45(18) of Directive 2014/59/EU, it shall, if appropriate, submit a legislative proposal amending this Regulation in the same way. CHAPTER 2 Early intervention Article 13 Early intervention 1. The ECB or national competent authorities shall inform the Board of any measure that they require an institution or group to take or that they take themselves pursuant to Article 16 of Regulation (EU) No 1024/2013, to Article 27(1) or Article 28 or 29 of Directive 2014/59/EU, or to Article 104 of Directive 2013/36/EU. The Board shall notify the Commission of any information which it has received pursuant to the first subparagraph. 2. From the date of receipt of the information referred to in paragraph 1, and without prejudice to the powers of the ECB and national competent authorities in accordance with other Union law, the Board may prepare for the resolution of the institution or group concerned. For the purposes of the first subparagraph, the ECB or the relevant national competent authority shall closely monitor, in cooperation with the Board, the conditions of the institution or the parent undertaking and their compliance with any early intervention measure that was required of them. The ECB or the relevant national competent authority shall provide the Board with all of the information necessary in order to update the resolution plan and prepare for the possible resolution of the institution and for valuation of the assets and liabilities of the institution in accordance with Article 20(1) to (15). 3. The Board shall have the power to require the institution, or the parent undertaking, to contact potential purchasers in order to prepare for the resolution of the institution, subject to the criteria specified in Article 39(2) of Directive 2014/59/EU and the requirements of professional secrecy laid down in Article 88 of this Regulation. The Board shall also have the power to require the relevant national resolution authority to draft a preliminary resolution scheme for the institution or group concerned. The Board shall inform the ECB, the relevant national competent authorities and the relevant national resolution authorities of any action it takes pursuant to this paragraph. 4. If the ECB or the national competent authorities intend to impose on an institution or a group any additional measure under Article 16 of Regulation (EU) No 1024/2013, under Article 27(1), 28 or 29 of Directive 2014/59/EU or under Article 104 of Directive 2013/36/EU, before the entity or group has fully complied with the first measure notified to the Board, they shall inform the Board before imposing such additional measure on the institution or group concerned. 5. The ECB or the national competent authority, the Board and the relevant national resolution authorities shall ensure that the additional measure referred to in paragraph 4 and any action of the Board aimed at preparing for resolution under paragraph 2 are consistent. CHAPTER 3 Resolution Article 14 Resolution objectives 1. When acting under the resolution procedure referred to in Article 18, the Board, the Council, the Commission, and, where relevant, the national resolution authorities, in respect of their respective responsibilities, shall take into account the resolution objectives, and choose the resolution tools and resolution powers which, in their view, best achieve the resolution objectives that are relevant in the circumstances of the case. 2. The resolution objectives referred to in paragraph 1 are the following: (a) to ensure the continuity of critical functions; (b) to avoid significant adverse effects on financial stability, in particular by preventing contagion, including to market infrastructures, and by maintaining market discipline; (c) to protect public funds by minimising reliance on extraordinary public financial support; (d) to protect depositors covered by Directive 2014/49/EU and investors covered by Directive 97/9/EC; (e) to protect client funds and client assets. When pursuing the objectives referred to in the first subparagraph, the Board, the Council, the Commission and, where relevant, the national resolution authorities, shall seek to minimise the cost of resolution and avoid destruction of value unless necessary to achieve the resolution objectives. 3. Subject to different provisions of this Regulation, the resolution objectives are of equal significance, and shall be balanced, as appropriate, to the nature and circumstances of each case. Article 15 General principles governing resolution 1. When acting under the resolution procedure referred to in Article 18, the Board, the Council, the Commission and, where relevant, the national resolution authorities, shall take all appropriate measures to ensure that the resolution action is taken in accordance with the following principles: (a) the shareholders of the institution under resolution bear first losses; (b) creditors of the institution under resolution bear losses after the shareholders in accordance with the order of priority of their claims pursuant to Article 17, save as expressly provided otherwise in this Regulation; (c) the management body and senior management of the institution under resolution are replaced, except in those cases where the retention of the management body and senior management, in whole or in part, as appropriate to the circumstances, is considered to be necessary for the achievement of the resolution objectives; (d) the management body and senior management of the institution under resolution shall provide all necessary assistance for the achievement of the resolution objectives; (e) natural and legal persons are made liable, subject to national law, under civil or criminal law, for their responsibility for the failure of the institution under resolution; (f) except where otherwise provided in this Regulation, creditors of the same class are treated in an equitable manner; (g) no creditor shall incur greater losses than would have been incurred if an entity referred to in Article 2 had been wound up under normal insolvency proceedings in accordance with the safeguards provided for in Article 29; (h) covered deposits are fully protected; and (i) resolution action is taken in accordance with the safeguards in this Regulation. 2. Where an institution is a group entity, without prejudice to Article 14, the Board, the Council and the Commission, when deciding on the application of resolution tools and the exercise of resolution powers, shall act in a way that minimises the impact on other group entities and on the group as a whole and minimises the adverse effect on financial stability in the Union and its Member States, in particular in the countries where the group operates. 3. Where the sale of business tool, the bridge institution tool or the asset separation tool is applied to an entity referred to in Article 2 of this Regulation, that entity shall be considered to be the subject of bankruptcy proceedings or analogous insolvency proceedings for the purposes of Article 5(1) of Council Directive 2001/23/EC (16). 4. When deciding on the application of resolution tools and the exercise of resolution powers, the Board shall instruct national resolution authorities to inform and consult employee representatives where appropriate. This is without prejudice to provisions on the representation of employees in management bodies as provided for by national law or practice. Article 16 Resolution of financial institutions and parent undertakings 1. The Board shall decide on a resolution action in relation to a financial institution established in a participating Member State, where the conditions laid down in Article 18(1) are met with regard to both the financial institution and with regard to the parent undertaking subject to consolidating supervision. 2. The Board shall take a resolution action in relation to a parent undertaking referred to in point (b) of Article 2, where the conditions laid down in Article 18(1) are met with regard to both that parent undertaking and with regard to one or more subsidiaries which are institutions or, where the subsidiary is not established in the Union, the third-country authority has determined that it meets the conditions for resolution under the law of that third country. 3. By way of derogation from paragraph 2 and notwithstanding the fact that a parent undertaking does not meet the conditions established in Article 18(1), the Board may decide on resolution action with regard to that parent undertaking when one or more of its subsidiaries which are institutions meet the conditions established in Article 18(1), (4) and (5) and their assets and liabilities are such that their failure threatens an institution or the group as a whole and resolution action with regard to that parent undertaking is necessary for the resolution of such subsidiaries which are institutions or for the resolution of the group as a whole. Where a national resolution authority informs the Board that the insolvency law of the Member State provides that groups be treated as a whole and resolution action with regard to the parent undertaking is necessary for the resolution of such subsidiaries which are institutions or for the resolution of the group as a whole, the Board may also decide on resolution action with regard to the parent undertaking. For the purposes of the first subparagraph, when assessing whether the conditions in Article 18(1) are met in respect of one or more subsidiaries which are institutions, the Board may disregard any intra-group capital or loss transfers between the entities, including the exercise of write-down or conversion powers. Article 17 Order of priority of claims 1. When applying the bail-in tool to an entity referred to in Article 2 of this Regulation, and without prejudice to liabilities excluded from the bail-in tool under Article 27(3) of this Regulation, the Board, the Commission, or, where applicable, the national resolution authorities, shall decide on the exercise of the write-down and conversion powers, including on any possible application of Article 27(5) of this Regulation, and the national resolution authorities shall exercise those powers in accordance with Articles 47 and 48 of Directive 2014/59/EU and in accordance with the reverse order of priority of claims laid down in their national law, including the provisions transposing Article 108 of that Directive. 2. Participating Member States shall notify to the Commission and to the Board the ranking of claims against entities referred to in Article 2 in national insolvency proceedings on 1 July of every year or immediately, where there is a change of the ranking. Where the bail-in tool is applied, the relevant deposit guarantee scheme shall be liable in the terms provided for in Article 79. Article 18 Resolution procedure 1. The Board shall adopt a resolution scheme pursuant to paragraph 6 in relation to entities and groups referred to in Article 7(2), and to the entities and groups referred to in Article 7(4)(b) and (5) where the conditions for the application of those paragraphs are met, only when it assesses, in its executive session, on receiving a communication pursuant to the fourth subparagraph, or on its own initiative, that the following conditions are met: (a) the entity is failing or is likely to fail; (b) having regard to timing and other relevant circumstances, there is no reasonable prospect that any alternative private sector measures, including measures by an IPS, or supervisory action, including early intervention measures or the write-down or conversion of relevant capital instruments in accordance with Article 21, taken in respect of the entity, would prevent its failure within a reasonable timeframe; (c) a resolution action is necessary in the public interest pursuant to paragraph 5. An assessment of the condition referred to in point (a) of the first subparagraph shall be made by the ECB, after consulting the Board. The Board, in its executive session, may make such an assessment only after informing the ECB of its intention and only if the ECB, within three calendar days of receipt of that information, does not make such an assessment. The ECB shall, without delay, provide the Board with any relevant information that the Board requests in order to inform its assessment. Where the ECB assesses that the condition referred to in point (a) of the first subparagraph is met in relation to an entity or group referred to in the first subparagraph, it shall communicate that assessment without delay to the Commission and to the Board. An assessment of the condition referred to in point (b) of the first subparagraph shall be made by the Board, in its executive session, or, where applicable, by the national resolution authorities, in close cooperation with the ECB. The ECB may also inform the Board or the national resolution authorities concerned that it considers the condition laid down in that point to be met. 2. Without prejudice to cases where the ECB has decided to exercise directly supervisory tasks relating to credit institutions pursuant to Article 6(5)(b) of Regulation (EU) No 1024/2013, in the event of receipt of a communication pursuant to paragraph 1 or where the Board intends to make an assessment under paragraph 1 on its own initiative in relation to an entity or group referred to in Article 7(3), the Board shall communicate its assessment to the ECB without delay. 3. The previous adoption of a measure pursuant to Article 16 of Regulation (EU) No 1024/2013, to Article 27(1) or Article 28 or 29 of Directive 2014/59/EU, or to Article 104 of Directive 2013/36/EU is not a condition for taking a resolution action. 4. For the purposes of point (a) of paragraph 1, the entity shall be deemed to be failing or to be likely to fail in one or more of the following circumstances: (a) the entity infringes, or there are objective elements to support a determination that the institution will, in the near future, infringe the requirements for continuing authorisation in a way that would justify the withdrawal of the authorisation by the ECB, including but not limited to the fact that the institution has incurred or is likely to incur losses that will deplete all or a significant amount of its own funds; (b) the assets of the entity are, or there are objective elements to support a determination that the assets of the entity will, in the near future, be less than its liabilities; (c) the entity is, or there are objective elements to support a determination that the entity will, in the near future, be unable to pay its debts or other liabilities as they fall due; (d) extraordinary public financial support is required except where, in order to remedy a serious disturbance in the economy of a Member State and preserve financial stability, that extraordinary public financial support takes any of the following forms: (i) a State guarantee to back liquidity facilities provided by central banks in accordance with the central banks' conditions; (ii) a State guarantee of newly issued liabilities; or (iii) an injection of own funds or purchase of capital instruments at prices and on terms that do not confer an advantage upon the entity, where neither the circumstances referred to in points (a), (b) and (c) of this paragraph nor the circumstances referred to in Article 21(1) are present at the time the public support is granted. In each of the cases referred to in points (i), (ii) and (iii) of point (d) of the first subparagraph, the guarantee or equivalent measures referred to therein shall be confined to solvent entities and shall be conditional on final approval under the Union State aid framework. Those measures shall be of a precautionary and temporary nature and shall be proportionate to remedy the consequences of the serious disturbance and shall not be used to offset losses that the entity has incurred or is likely to incur in the near future. Support measures under point (d)(iii) of the first subparagraph shall be limited to injections necessary to address capital shortfall established in the national, Union or SSM-wide stress tests, asset quality reviews or equivalent exercises conducted by the ECB, EBA or national authorities, where applicable, confirmed by the competent authority. If the Commission submits a legislative proposal pursuant to Article 32(4) of Directive 2014/59/EU, it shall, if appropriate, submit a legislative proposal amending this Regulation in the same way. 5. For the purposes of point (c) of paragraph 1 of this Article, a resolution action shall be treated as in the public interest if it is necessary for the achievement of, and is proportionate to one or more of the resolution objectives referred to in Article 14 and winding up of the entity under normal insolvency proceedings would not meet those resolution objectives to the same extent. 6. If the conditions laid down in paragraph 1 are met, the Board shall adopt a resolution scheme. The resolution scheme shall: (a) place the entity under resolution; (b) determine the application of the resolution tools to the institution under resolution referred to in Article 22(2), in particular any exclusions from the application of the bail-in in accordance with Article 27(5) and (14); (c) determine the use of the Fund to support the resolution action in accordance with Article 76 and in accordance with a Commission decision taken in accordance with Article 19. 7. Immediately after the adoption of the resolution scheme, the Board shall transmit it to the Commission. Within 24 hours from the transmission of the resolution scheme by the Board, the Commission shall either endorse the resolution scheme, or object to it with regard to the discretionary aspects of the resolution scheme in the cases not covered in the third subparagraph of this paragraph. Within 12 hours from the transmission of the resolution scheme by the Board, the Commission may propose to the Council: (a) to object to the resolution scheme on the ground that the resolution scheme adopted by the Board does not fulfil the criterion of public interest referred to in paragraph 1(c); (b) to approve or object to a material modification of the amount of the Fund provided for in the resolution scheme of the Board. For the purposes of the third subparagraph, the Council shall act by simple majority. The resolution scheme may enter into force only if no objection has been expressed by the Council or by the Commission within a period of 24 hours after its transmission by the Board. The Council or the Commission, as the case may be, shall provide reasons for the exercise of their power of objection. Where, within 24 hours from the transmission of the resolution scheme by the Board, the Council has approved the proposal of the Commission for modification of the resolution scheme on the ground referred to in point (b) of the third subparagraph or the Commission has objected in accordance with the second subparagraph, the Board shall, within eight hours modify the resolution scheme in accordance with the reasons expressed. Where the resolution scheme adopted by the Board provides for the exclusion of certain liabilities in the exceptional circumstances referred to in Article 27(5), and where such exclusion requires a contribution by the Fund or an alternative financing source, in order to protect the integrity of the internal market, the Commission may prohibit or require amendments to the proposed exclusion setting out adequate reasons based on an infringement of the requirements laid down in Article 27 and in the delegated act adopted by the Commission on the basis of Article 44(11) of Directive 2014/59/EU. 8. Where the Council objects to the placing of an institution under resolution on the ground that the public interest criterion referred to in paragraph 1(c) is not fulfilled, the relevant entity shall be wound up in an orderly manner in accordance with the applicable national law. 9. The Board shall ensure that the necessary resolution action is taken to carry out the resolution scheme by the relevant national resolution authorities. The resolution scheme shall be addressed to the relevant national resolution authorities and shall instruct those authorities, which shall take all necessary measures to implement it in accordance with Article 29, by exercising resolution powers. Where State aid or Fund aid is present, the Board shall act in conformity with a decision on that aid taken by the Commission. 10. The Commission shall have the power to obtain from the Board any information which it deems to be relevant for performing its tasks under this Regulation. The Board shall have the power to obtain from any person, in accordance with Chapter 5 of this Title, any information necessary for it to prepare and decide upon a resolution action, including updates and supplements of information provided in the resolution plans. Article 19 State aid and Fund aid 1. Where resolution action involves the granting of State aid pursuant to Article 107(1) TFEU or of Fund aid in accordance with paragraph 3 of this Article, the adoption of the resolution scheme under Article 18(6) of this Regulation shall not take place until such time as the Commission has adopted a positive or conditional decision concerning the compatibility of the use of such aid with the internal market. In performing the tasks conferred on them by Article 18 of this Regulation, Union institutions shall act in conformity with the principles established in Article 3(3) of Directive 2014/59/EU and shall make public in an appropriate manner all relevant information on their internal organisation in this regard. 2. On receiving a communication pursuant to Article 18(1) of this Regulation or on its own initiative, if the Board considers that resolution actions could constitute State aid pursuant to Article 107(1) TFEU, it shall invite the participating Member State or Member States concerned to immediately notify the envisaged measures to the Commission under Article 108(3) TFEU. The Board shall notify the Commission of any case in which it invites one or more Member States to make a notification under Article 108(3) TFEU. 3. To the extent that the resolution action as proposed by the Board involves the use of the Fund, the Board shall notify the Commission of the proposed use of the Fund. The Board's notification shall include all of the information necessary to enable the Commission to make its assessments pursuant to this paragraph. The notification under this paragraph shall trigger a preliminary investigation by the Commission during the course of which the Commission may request further information from the Board. The Commission shall assess whether the use of the Fund would distort, or threaten to distort, competition by favouring the beneficiary or any other undertaking so as, insofar as it would affect trade between Member States, to be incompatible with the internal market. The Commission shall apply to the use of the Fund the criteria established for the application of State aid rules as enshrined in Article 107 TFEU. The Board shall provide the Commission with the information that the Commission deems to be necessary to carry out that assessment. If the Commission has serious doubts as to the compatibility of the proposed use of the Fund with the internal market, or where the Board has failed to provide the necessary information pursuant to a request of the Commission under the second subparagraph, the Commission shall open an in-depth investigation and shall notify the Board accordingly. The Commission shall publish its decision to open an in-depth investigation in the Official Journal of the European Union. The Board, any Member State or any person, undertaking or association whose interests may be affected by the use of the Fund, may submit comments to the Commission within such timeframe as may be specified in the notification. The Board may submit observations on the comments submitted by Member States and interested third parties within such timeframe as may be specified by the Commission. At the end of the period of investigation the Commission shall make its assessment as to whether the use of the Fund would be compatible with the internal market. In making its assessments and conducting its investigations pursuant to this paragraph, the Commission shall be guided by all of the relevant regulations adopted under Article 109 TFEU as well as relevant communications, guidance and measures adopted by the Commission in application of the rules of the Treaties relating to State aid as are in force at the time the assessment is to be made. Those measures shall be applied as though references to the Member State responsible for notifying the aid were references to the Board, and with any other necessary modifications. The Commission shall adopt a decision on the compatibility of the use of the Fund with the internal market, which shall be addressed to the Board and to the national resolution authorities of the Member State or Member States concerned. That decision may be contingent on conditions, commitments or undertakings in respect of the beneficiary. The decision may also lay down obligations on the Board, the national resolution authorities in the participating Member State or Member States concerned or the beneficiary to enable compliance with it to be monitored. This may include requirements for the appointment of a trustee or other independent person to assist in monitoring. A trustee or other independent person may perform such functions as may be specified in the Commission decision. Any decision pursuant to this paragraph shall be published in the Official Journal of the European Union. The Commission may issue a negative decision, addressed to the Board, where it decides that the proposed use of the Fund would be incompatible with the internal market and cannot be implemented in the form proposed by the Board. On receipt of such a decision the Board shall reconsider its resolution scheme and prepare a revised resolution scheme. 4. Where the Commission has serious doubts as to whether its decision under paragraph 3 is being complied with, it shall conduct the necessary investigations. For that purpose, the Commission may exercise such powers as are available to it under the regulations and other measures referred to in the fourth subparagraph of paragraph 3, and shall be guided by them. 5. If, on the basis of the investigations carried out by the Commission, and after giving notice to the parties concerned to submit their comments, the Commission considers that the decision under paragraph 3 has not been complied with, it shall issue a decision to the national resolution authority in the participating Member State concerned requiring that authority to recover the misused amounts within a period to be determined by the Commission. The Fund aid to be recovered pursuant to a recovery decision shall include interest at an appropriate rate fixed by the Commission and shall be paid over to the Board. The Board shall pay any amounts received under the first subparagraph into the Fund and take such amounts into consideration when determining contributions in accordance with Articles 70 and 71. The recovery procedure referred to in the first subparagraph shall respect the right to good administration and the right of access to documents, of the beneficiaries, as laid down in Articles 41 and 42 of the Charter. 6. Without prejudice to the reporting obligations that the Commission may establish in its decision under paragraph 3 of this Article, the Board shall submit to the Commission annual reports assessing the compliance of the use of the Fund with the decision under that paragraph, for the drawing up of which the Board shall make use of its powers under Article 34. 7. Any Member State or any person, undertaking or association whose interests may be affected by the use of the Fund, in particular the entities referred to in Article 2, shall have the right to inform the Commission of any suspected misuse of the Fund incompatible with the decision under paragraph 3 of this Article. 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 93 concerning detailed rules of procedure concerning: (a) the calculation of the interest rate to be applied in the event of a recovery decision in accordance with paragraph 5; (b) the guarantees of the right to good administration and the right of access to documents referred to in paragraph 5. 9. Where the Commission, following a recommendation of the Board or on its own initiative, considers that the application of resolution tools and actions does not respond to the criteria on the basis of which its initial decision under paragraph 3 was made, it may review such a decision and adopt the appropriate amendments. 10. By way of derogation from paragraph 3, on application by a Member State, the Council may, acting unanimously, decide that the use of the Fund shall be considered to be compatible with the internal market, if such a decision is justified by exceptional circumstances. If, however, the Council has not made its attitude known within seven days of the said application being made, the Commission shall give its decision on the case. 11. Participating Member States shall ensure that their national resolution authorities have the powers necessary to ensure compliance with any conditions laid down in a Commission decision pursuant to paragraph 3 and to recover misused amounts pursuant to a Commission decision under paragraph 5. Article 20 Valuation for the purposes of resolution 1. Before deciding on resolution action or the exercise of the power to write down or convert relevant capital instruments, the Board shall ensure that a fair, prudent and realistic valuation of the assets and liabilities of an entity referred to in Article 2 is carried out by a person independent from any public authority, including the Board and the national resolution authority, and from the entity concerned. 2. Subject to paragraph 15, where all of the requirements laid down in paragraphs 1 and 4 to 9 are met, the valuation shall be considered to be definitive. 3. Where an independent valuation in accordance with paragraph 1 is not possible, the Board may carry out a provisional valuation of the assets and liabilities of the entity referred to in Article 2, in accordance with paragraph 10 of this Article. 4. The objective of the valuation shall be to assess the value of the assets and liabilities of an entity referred to in Article 2 that meets the conditions for resolution of Articles 16 and 18. 5. The purposes of the valuation shall be: (a) to inform the determination of whether the conditions for resolution or the conditions for the write-down or conversion of capital instruments are met; (b) if the conditions for resolution are met, to inform the decision on the appropriate resolution action to be taken in respect of an entity referred to in Article 2; (c) when the power to write down or convert relevant capital instruments is applied, to inform the decision on the extent of the cancellation or dilution of instruments of ownership, and the extent of the write-down or conversion of relevant capital instruments; (d) when the bail-in tool is applied, to inform the decision on the extent of the write-down or conversion of eligible liabilities; (e) when the bridge institution tool or asset separation tool is applied, to inform the decision on the assets, rights, liabilities or instruments of ownership to be transferred and the decision on the value of any consideration to be paid to the institution under resolution or, as the case may be, to the owners of the instruments of ownership; (f) when the sale of business tool is applied, to inform the decision on the assets, rights, liabilities or instruments of ownership to be transferred and to inform the Board's understanding of what constitutes commercial terms for the purposes of Article 24(2)(b); (g) in all cases, to ensure that any losses on the assets of an entity referred to in Article 2 are fully recognised at the moment the resolution tools are applied or the power to write down or convert relevant capital instruments is exercised. 6. Without prejudice to the Union State aid framework, where applicable, the valuation shall be based on prudent assumptions, including as to rates of default and severity of losses. The valuation shall not assume any potential future provision of any extraordinary public financial support, any central bank emergency liquidity assistance, or any central bank liquidity assistance provided under non-standard collateralisation, tenor and interest rate terms to an entity referred to in Article 2 from the point at which resolution action is taken or the power to write down or convert relevant capital instruments is exercised. Furthermore, the valuation shall take account of the fact that, if any resolution tool is applied: (a) the Board may recover any reasonable expenses properly incurred from the institution under resolution, in accordance with Article 22(6); (b) the Fund may charge interest or fees in respect of any loans or guarantees provided to the institution under resolution, in accordance with Article 76. 7. The valuation shall be supplemented by the following information as appearing in the accounting books and records of an entity referred to in Article 2: (a) an updated balance sheet and a report on the financial position of an entity referred to in Article 2; (b) an analysis and an estimate of the accounting value of the assets; (c) the list of outstanding on-balance-sheet and off-balance-sheet liabilities shown in the books and records of an entity referred to in Article 2, with an indication of the respective credits and priority of claims referred to in Article 17. 8. Where appropriate, to inform the decisions referred to in paragraph 5(e) and (f) of this Article, the information in paragraph 7(b) of this Article may be complemented by an analysis and estimate of the value of the assets and liabilities of an entity referred to in Article 2 on a market value basis. 9. The valuation shall indicate the subdivision of the creditors in classes in accordance with the priority of claims referred to in Article 17 and an estimate of the treatment that each class of shareholders and creditors would have been expected to receive, if an entity referred to in Article 2 were wound up under normal insolvency proceedings. That estimate shall not affect the application of the ‘no creditor worse off’ principle referred to in Article 15(1)(g). 10. Where, due to urgency in the circumstances of the case, either it is not possible to comply with the requirements laid down in paragraphs 7 and 9, or paragraph 3 applies, a provisional valuation shall be carried out. The provisional valuation shall comply with the requirements laid down in paragraph 4 and, in so far as reasonably practicable in the circumstances, with the requirements laid down in paragraphs 1, 7 and 9. The provisional valuation referred to in the first subparagraph shall include a buffer for additional losses, with appropriate justification. 11. A valuation that does not comply with all of the requirements laid down in paragraphs 1 and 4 to 9 shall be considered to be provisional until an independent person as referred to in paragraph 1 has carried out a valuation that is fully compliant with all of the requirements laid down in those paragraphs. That ex-post definitive valuation shall be carried out as soon as practicable. It may be carried out either separately from the valuation referred to in paragraphs 16, 17 and 18, or simultaneously with and by the same independent person as that valuation, but shall be distinct from it. The purposes of the ex-post definitive valuation shall be: (a) to ensure that any losses on the assets of an entity referred to in Article 2 are fully recognised in the books of accounts of that entity; (b) to inform the decision to write back creditors' claims or to increase the value of the consideration paid, in accordance with paragraph 12 of this Article. 12. In the event that the ex-post definitive valuation's estimate of the net asset value of an entity referred to in Article 2 is higher than the provisional valuation's estimate of the net asset value of that entity, the Board may request the national resolution authority to: (a) exercise its power to increase the value of the claims of creditors or owners of relevant capital instruments which have been written down under the bail-in tool; (b) instruct a bridge institution or asset management vehicle to make a further payment of consideration in respect of the assets, rights or liabilities to an institution under resolution, or as the case may be, in respect of the instruments of ownership to the owners of those instruments of ownership. 13. Notwithstanding paragraph 1, a provisional valuation conducted in accordance with paragraphs 10 and 11 shall be a valid basis for the Board to decide on resolution actions, including instructing national resolution authorities to take control of a failing institution or on the exercise of the write-down or conversion power of relevant capital instruments. 14. The Board shall establish and maintain arrangements to ensure that the assessment for the application of the bail-in tool in accordance with Article 27 and the valuation referred to in paragraphs 1 to 15 of this Article are based on information about the assets and liabilities of the institution under resolution that is as up to date and complete as is reasonably possible. 15. The valuation shall be an integral part of the decision on the application of a resolution tool or on the exercise of a resolution power or the decision on the exercise of the write-down or conversion power of capital instruments. The valuation itself shall not be subject to a separate right of appeal but may be subject to an appeal together with the decision of the Board. 16. For the purposes of assessing whether shareholders and creditors would have received better treatment if the institution under resolution had entered into normal insolvency proceedings, the Board shall ensure that a valuation is carried out by an independent person as referred to in paragraph 1 as soon as possible after the resolution action or actions have been effected. That valuation shall be distinct from the valuation carried out under paragraphs 1 to 15. 17. The valuation referred to in paragraph 16 shall determine: (a) the treatment that shareholders and creditors, or the relevant deposit guarantee schemes, would have received if an institution under resolution with respect to which the resolution action or actions have been effected, had entered normal insolvency proceedings at the time when the decision on the resolution action was taken; (b) the actual treatment that shareholders and creditors have received in the resolution of an institution under resolution; and (c) whether there is any difference between the treatment referred to in point (a) of this paragraph and the treatment referred to in point (b) of this paragraph. 18. The valuation referred to in paragraph 16 shall: (a) assume that an institution under resolution with respect to which the resolution action or actions have been effected, would have entered normal insolvency proceedings at the time when the decision on the resolution action was taken; (b) assume that the resolution action or actions had not been effected; (c) disregard any provision of extraordinary public financial support to an institution under resolution. Article 21 Write-down and conversion of capital instruments 1. The Board shall exercise the power to write down or convert relevant capital instruments acting under the procedure laid down in Article 18, in relation to the entities and groups referred to in Article 7(2), and to the entities and groups referred to in Article 7(4)(b) and (5), where the conditions for the application of those paragraphs are met, only where it assesses, in its executive session, on receiving a communication pursuant to the second subparagraph or on its own initiative, that one or more of the following conditions are met: (a) where the determination has been made that the conditions for resolution specified in Articles 16 and 18 have been met, before any resolution action is taken; (b) the entity will no longer be viable unless the relevant capital instruments are written down or converted into equity; (c) in the case of relevant capital instruments issued by a subsidiary and where those relevant capital instruments are recognised for the purposes of meeting own funds requirements on an individual basis and on a consolidated basis, unless the write-down or conversion power is exercised in relation to those instruments, the group will no longer be viable; (d) in the case of relevant capital instruments issued at the level of the parent undertaking and where those relevant capital instruments are recognised for the purposes of meeting own funds requirements on an individual basis at the level of the parent undertaking or on a consolidated basis, unless the write-down or conversion power is exercised in relation to those instruments, the group will no longer be viable; (e) extraordinary public financial support is required by the entity or group, except in any of the circumstances set out in point (d)(iii) of Article 18(4). The assessment of the conditions referred to in points (a), (c) and (d) of the first subparagraph shall be made by the ECB, after consulting the Board. The Board, in its executive session, may also make such assessment. 2. Regarding the assessment of whether the entity or group is viable, the Board, in its executive session, may make such an assessment only after informing the ECB of its intention and only if the ECB, within three calendar days of receipt of such information, does not make such an assessment. The ECB shall, without delay, provide the Board with any relevant information that the Board requests in order to inform its assessment. 3. For the purposes of paragraph 1 of this Article, an entity referred to in Article 2 or a group shall be deemed to be no longer viable only if both of the following conditions are met: (a) that entity or group is failing or is likely to fail; (b) having regard to timing and other relevant circumstances, there is no reasonable prospect that any action, including alternative private sector measures or supervisory action (including early intervention measures), other than the write-down or conversion of relevant capital instruments, independently or in combination with resolution action, would prevent the failure of that entity or group within a reasonable timeframe. 4. For the purposes of point (a) of paragraph 3 of this Article, that entity shall be deemed to be failing or to be likely to fail where one or more of the circumstances referred to in Article 18(4) occur. 5. For the purposes of point (a) of paragraph 3, a group shall be deemed to be failing or to be likely to fail where the group infringes, or there are objective elements to support a determination that the group, in the near future, will infringe its consolidated prudential requirements in a way that would justify action by the ECB or the national competent authority, including but not limited to the fact that the group has incurred or is likely to incur losses that will deplete all or a significant amount of its own funds. 6. A relevant capital instrument issued by a subsidiary shall not be written down to a greater extent or converted on worse terms pursuant to Article 59(3)(c) of Directive 2014/59/EU than equally ranked capital instruments at the level of the parent undertaking which have been written down or converted. 7. If one or more of the conditions referred to in paragraph 1 are met, the Board, acting under the procedure laid down in Article 18, shall determine whether the powers to write down or convert relevant capital instruments are to be exercised independently or, in accordance with the procedure under Article 18, in combination with a resolution action. 8. Where the Board, acting under the procedure laid down in Article 18 of this Regulation, determines that one or more of the conditions referred to in paragraph 1 of this Article are met, but the conditions for resolution in accordance with Article 18(1) of this Regulation are not met, it shall instruct, without delay, the national resolution authorities to exercise the write-down or conversion powers in accordance with Articles 59 and 60 of Directive 2014/59/EU. The Board shall ensure that before national resolution authorities exercise the power to write down or convert relevant capital instruments, a valuation of the assets and liabilities of an entity referred to in Article 2 or a group is carried out in accordance with Article 20(1) to (15). That valuation shall form the basis of the calculation of the write-down to be applied to the relevant capital instruments in order to absorb losses and the level of conversion to be applied to relevant capital instruments in order to recapitalise the entity referred to in Article 2 or the group. 9. Where one or more of the conditions referred to in paragraph 1 are met, and the conditions referred to in Article 18(1) are also met, the procedure laid down in Article 18(6), (7) and (8) shall apply. 10. The Board shall ensure that the national resolution authorities exercise the write-down or conversion powers without delay, in accordance with the priority of claims pursuant to Article 17 and in a way that produces the following results: (a) Common Equity Tier 1 items are reduced first in proportion to the losses and to the extent of their capacity; (b) the principal amount of Additional Tier 1 instruments is written down or converted into Common Equity Tier 1 instruments or both, to the extent required to achieve the resolution objectives set out in Article 14 or to the extent of the capacity of the relevant capital instruments, whichever is lower; (c) the principal amount of Tier 2 instruments is written down or converted into Common Equity Tier 1 instruments or both, to the extent required to achieve the resolution objectives set out in Article 14 or to the extent of the capacity of the relevant capital instruments, whichever is lower. 11. The national resolution authorities shall implement the instructions of the Board and exercise the write-down or conversion of relevant capital instruments in accordance with Article 29. Article 22 General principles of resolution tools 1. Where the Board decides to apply a resolution tool to an entity or group referred to in Article 7(2) or to an entity or group referred to in Article 7(4)(b) and (5) where the conditions for the application of those paragraphs are met, and that resolution action would result in losses being borne by creditors or their claims being converted, the Board shall instruct the national resolution authorities to exercise the power to write down and convert relevant capital instruments in accordance with Article 21 immediately before or together with the application of the resolution tool. 2. The resolution tools referred to in point (b) of Article 18(6) are the following: (a) the sale of business tool; (b) the bridge institution tool; (c) the asset separation tool; (d) the bail-in tool. 3. When adopting the resolution scheme referred to in Article 18(6), the Board shall take into consideration the following factors: (a) the assets and liabilities of the institution under resolution on the basis of the valuation pursuant to Article 20; (b) the liquidity position of the institution under resolution; (c) the marketability of the franchise value of the institution under resolution in the light of the competitive and economic conditions of the market; (d) the time available. 4. The resolution tools shall be applied to meet the resolution objectives specified in Article 14, in accordance with the resolution principles specified in Article 15. They may be applied either individually or in any combination, except for the asset separation tool which may be applied only together with another resolution tool. 5. Where the resolution tools referred to in point (a) or (b) of paragraph 2 of this Article are used to transfer only part of the assets, rights or liabilities of the institution under resolution, the residual entity referred to in Article 2 from which the assets, rights or liabilities have been transferred, shall be wound up under normal insolvency proceedings. 6. The Board may recover any reasonable expenses properly incurred in connection with the use of the resolution tools or powers in one or more of the following ways: (a) as a deduction from any consideration paid by a recipient to the institution under resolution or, as the case may be, to the owners of instruments of ownership; (b) from the institution under resolution, as a preferred creditor; or (c) from any proceeds generated as a result of the termination of the operation of the bridge institution or the asset management vehicle, as a preferred creditor. Any proceeds received by national resolution authorities in connection with the use of the Fund shall be reimbursed to the Board. Article 23 Resolution Scheme The resolution scheme adopted by the Board under Article 18 shall establish, in accordance with any decision on State aid or Fund aid, the details of the resolution tools to be applied to the institution under resolution concerning at least the measures referred to in Article 24(2), Article 25(2), Article 26(2) and Article 27(1), to be implemented by the national resolution authorities in accordance with the relevant provisions of Directive 2014/59/EU as transposed into national law, and determine the specific amounts and purposes for which the Fund shall be used. The resolution scheme shall outline the resolution actions that should be taken by the Board in relation to the Union parent undertaking or particular group entities established in the participating Member States with the aim of meeting the resolution objectives and principles as referred to in Articles 14 and 15. When adopting a resolution scheme, the Board, the Council and the Commission shall take into account and follow the resolution plan as referred to in Article 8 unless the Board assesses, taking into account the circumstances of the case, that the resolution objectives will be achieved more effectively by taking actions which are not provided for in the resolution plan. In the course of the resolution process, the Board may amend and update the resolution scheme as appropriate in light of the circumstances of the case. For amendments and updates the procedure laid down in Article 18 shall apply. In addition, the resolution scheme shall provide, where appropriate, for the appointment by the national resolution authorities of a special manager for the institution under resolution pursuant to Article 35 of Directive 2014/59/EU. The Board may establish that the same special manager is appointed for all of the entities affiliated to a group where that is necessary in order to facilitate solutions redressing the financial soundness of the entities concerned. Article 24 Sale of business tool 1. Within the resolution scheme, the sale of business tool shall consist of the transfer to a purchaser that is not a bridge institution of the following: (a) instruments of ownership issued by an institution under resolution; or (b) all or any assets, rights or liabilities of an institution under resolution. 2. Concerning the sale of business tool, the resolution scheme shall establish: (a) the instruments, assets, rights and liabilities to be transferred by the national resolution authority in accordance with Article 38(1) and (7) to (11) of Directive 2014/59/EU; (b) the commercial terms, having regard to the circumstances and the costs and expenses incurred in the resolution process, pursuant to which the national resolution authority shall make the transfer in accordance with Article 38(2), (3) and (4) of Directive 2014/59/EU; (c) whether the transfer powers may be exercised by the national resolution authority more than once in accordance with Article 38(5) and (6) of Directive 2014/59/EU; (d) the arrangements for the marketing by the national resolution authority of that entity or those instruments, assets, rights and liabilities in accordance with Article 39(1) and (2) of Directive 2014/59/EU; (e) whether the compliance with the marketing requirements by the national resolution authority is likely to undermine the resolution objectives in accordance with paragraph 3 of this Article. 3. The Board shall apply the sale of business tool without complying with the marketing requirements laid down in point (e) of paragraph 2 when it determines that compliance with those requirements would be likely to undermine one or more of the resolution objectives and in particular where the following conditions are met: (a) it considers that there is a material threat to financial stability arising from or aggravated by the failure or likely failure of the institution under resolution; and (b) it considers that compliance with those requirements would be likely to undermine the effectiveness of the sale of business tool in addressing that threat or achieving the resolution objective specified in point (b) of Article 14(2). Article 25 Bridge institution tool 1. Within the resolution scheme, the bridge institution tool shall consist of the transfer to a bridge institution of any of the following: (a) instruments of ownership issued by one or more institutions under resolution; (b) all or any assets, rights or liabilities of one or more institutions under resolution. 2. With regard to the bridge institution tool, the resolution scheme shall establish: (a) the instruments, assets, rights and liabilities to be transferred to a bridge institution by the national resolution authority in accordance with Article 40(1) to (12) of Directive 2014/59/EU; (b) the arrangements for the setting up, the operation and the termination of the bridge institution by the national resolution authority in accordance with Article 41(1), (2), (3) and (5) to (9) of Directive 2014/59/EU; (c) the arrangements for the marketing of the bridge institution or its assets or liabilities by the national resolution authority in accordance with Article 41(4) of Directive 2014/59/EU. 3. The Board shall ensure that the total value of liabilities transferred by the national resolution authority to the bridge institution does not exceed the total value of the rights and assets transferred from the institution under resolution or provided by other sources. Article 26 Asset separation tool 1. Within the resolution scheme, the asset separation tool shall consist of the transfer of assets, rights or liabilities of an institution under resolution or a bridge institution to one or more asset management vehicles. 2. Concerning the asset separation tool, the resolution scheme shall establish: (a) the assets, rights and liabilities to be transferred by the national resolution authority to an asset management vehicle in accordance with Article 42(1) to (5) and (8) to (13) of Directive 2014/59/EU; (b) the consideration for which the assets, rights and liabilities are to be transferred by the national resolution authority to the asset management vehicle in accordance with the principles established in Article 20 of this Regulation, with Article 42(7) of Directive 2014/59/EU and with the Union State aid framework. Point (b) of the first subparagraph shall not prevent the consideration having nominal or negative value. Article 27 Bail-in tool 1. The bail-in tool may be applied for any of the following purposes: (a) to recapitalise an entity referred to in Article 2 of this Regulation that meets the conditions for resolution to the extent sufficient to restore its ability to comply with the conditions for authorisation (to the extent that those conditions apply to the entity) and to continue to carry out the activities for which it is authorised under Directive 2013/36/EU or Directive 2014/65/EU, where the entity is authorised under those Directives, and to sustain sufficient market confidence in the institution or entity; (b) to convert to equity or reduce the principal amount of claims or debt instruments that are transferred: (i) to a bridge institution with a view to providing capital for that bridge institution; or (ii) under the sale of business tool or the asset separation tool. Within the resolution scheme, concerning the bail-in tool, the following shall be established: (a) the aggregate amount by which eligible liabilities must be reduced or converted, in accordance with paragraph 13; (b) the liabilities that may be excluded in accordance with paragraphs 5 to 14; (c) the objectives and minimum content of the business reorganisation plan to be submitted in accordance with paragraph 16. 2. The bail-in tool may be applied for the purpose referred to in point (a) of paragraph 1 only if there is a reasonable prospect that the application of that tool, together with other relevant measures including measures implemented in accordance with the business reorganisation plan required by paragraph 16 will, in addition to achieving relevant resolution objectives, restore the entity in question to financial soundness and long-term viability. Any of the resolution tools referred to in Article 22(2)(a), (b) and (c), and the bail-in tool referred to in point (d) of that paragraph, shall apply, as appropriate, where the conditions laid down in the first subparagraph are not met. 3. The following liabilities, whether they are governed by the law of a Member State or of a third country, shall not be subject to write-down or conversion: (a) covered deposits; (b) secured liabilities including covered bonds and liabilities in the form of financial instruments used for hedging purposes which form an integral part of the cover pool and which, in accordance with national law, are secured in a way similar to covered bonds; (c) any liability that arises by virtue of the holding by an institution or entity referred to in Article 2 of this Regulation of client assets or client money, including client assets or client money held on behalf of UCITS as defined in Article 1(2) of Directive 2009/65/EC or of AIFs as defined in Article 4(1)(a) of Directive 2011/61/EU of the European Parliament and of the Council (17), provided that such client is protected under the applicable insolvency law; (d) any liability that arises by virtue of a fiduciary relationship between an entity referred to in Article 2 (as fiduciary) and another person (as beneficiary), provided that such beneficiary is protected under the applicable insolvency or civil law; (e) liabilities to institutions, excluding entities that are part of the same group, with an original maturity of less than seven days; (f) liabilities with a remaining maturity of less than seven days, owed to systems or operators of systems designated in accordance with Directive 98/26/EC of the European Parliament and of the Council (18) or their participants and arising from the participation in such a system; (g) a liability to any one of the following: (i) an employee, in relation to accrued salary, pension benefits or other fixed remuneration, except for the variable component of remuneration that is not regulated by a collective bargaining agreement; (ii) a commercial or trade creditor arising from the provision to the institution or entity referred to in Article 2 of goods or services that are critical to the daily functioning of its operations, including IT services, utilities and the rental, servicing and upkeep of premises; (iii) tax and social security authorities, provided that those liabilities are preferred under the applicable law; (iv) deposit guarantee schemes arising from contributions due in accordance with Directive 2014/49/EU. Point (g)(i) of the first subparagraph shall not apply to the variable component of the remuneration of material risk takers as identified in Article 92(2) of Directive 2013/36/EU. 4. The scope of the bail-in tool referred to in paragraph 3 of this Article shall not prevent, where appropriate, the exercise of the bail-in powers to any part of a secured liability or a liability for which collateral has been pledged that exceeds the value of the assets, pledge, lien or collateral against which it is secured or to any amount of a deposit that exceeds the coverage level provided for in Article 6 of Directive 2014/49/EU. The Board shall ensure that all secured assets relating to a covered bond cover pool remain unaffected, segregated and with enough funding. Without prejudice to the large exposure rules in Regulation (EU) No 575/2013 and Directive 2013/36/EU, and in order to provide for the resolvability of entities and groups, the Board shall instruct the national resolution authorities to limit, in accordance with Article 10(11)(b) of this Regulation, the extent to which other institutions hold liabilities eligible for a bail-in tool, save for liabilities that are held at entities that are part of the same group. 5. In exceptional circumstances, where the bail-in tool is applied, certain liabilities may be excluded or partially excluded from the application of the write-down or conversion powers where: (a) it is not possible to bail-in that liability within a reasonable time notwithstanding the good faith efforts of the relevant national resolution authority; (b) the exclusion is strictly necessary and is proportionate to achieve the continuity of critical functions and core business lines in a manner that maintains the ability of the institution under resolution to continue key operations, services and transactions; (c) the exclusion is strictly necessary and proportionate to avoid giving rise to widespread contagion, in particular as regards eligible deposits held by natural persons and micro, small and medium-sized enterprises, which would severely disrupt the functioning of financial markets, including of financial market infrastructures, in a manner that could cause a serious disturbance to the economy of a Member State or of the Union; or (d) the application of the bail-in tool to those liabilities would cause a destruction in value such that the losses borne by other creditors would be higher than if those liabilities were excluded from bail-in. Where an eligible liability or class of eligible liabilities is excluded or partially excluded under this paragraph, the level of write-down or conversion applied to other eligible liabilities may be increased to take account of such exclusions provided that the level of write-down and conversion applied to other eligible liabilities complies with the principle laid down in point (g) of Article 15(1). 6. Where an eligible liability or class of eligible liabilities is excluded or partially excluded pursuant to paragraph 5, and the losses that would have been borne by those liabilities have not been passed on fully to other creditors, a contribution from the Fund may be made to the institution under resolution to do one or both of the following: (a) cover any losses which have not been absorbed by eligible liabilities and restore the net asset value of the institution under resolution to zero in accordance with point (a) of paragraph 13; (b) purchase instruments of ownership or capital instruments in the institution under resolution, in order to recapitalise the institution in accordance with point (b) of paragraph 13. 7. The Fund may make a contribution referred to in paragraph 6 only where: (a) a contribution to loss absorption and recapitalisation equal to an amount not less than 8 % of the total liabilities including own funds of the institution under resolution, measured at the time of resolution action in accordance with the valuation provided for in Article 20(1) to (15), has been made by shareholders, the holders of relevant capital instruments and other eligible liabilities through write-down, conversion or otherwise; and (b) the contribution from the Fund does not exceed 5 % of the total liabilities including own funds of the institution under resolution, measured at the time of resolution action in accordance with the valuation provided for in Article 20(1) to (15). 8. The contribution of the Fund referred to in paragraph 7 of this Article may be financed by: (a) the amount available to the Fund which has been raised through contributions by entities referred to in Article 2 of this Regulation in accordance with the rules laid down in Directive 2014/59/EU and in Article 67(4) and Articles 70 and 71 of this Regulation; (b) where the amounts referred to in point (a) of this paragraph are insufficient, amounts raised from alternative funding means in accordance with Articles 73 and 74. 9. In extraordinary circumstances, further funding may be sought from alternative financing sources after: (a) the 5 % limit specified in point (b) of paragraph 7 has been reached; and (b) all unsecured, non-preferred liabilities, other than eligible deposits, have been written down or converted in full. 10. As an alternative or in addition, where the conditions laid down in points (a) and (b) of paragraph 9 are met, a contribution may be made from resources which have been raised through ex-ante contributions in accordance with Article 70 and which have not yet been used. 11. For the purposes of this Regulation, Article 44(8) of Directive 2014/59/EU shall not apply. 12. When taking the decision referred to in paragraph 5, due consideration shall be given to: (a) the principle that losses should be borne first by shareholders and next, in general, by creditors of the institution under resolution in order of preference; (b) the level of loss absorbing capacity that would remain in the institution under resolution if the liability or class of liabilities were excluded; and (c) the need to maintain adequate resources for resolution financing. 13. The Board shall assess, on the basis of a valuation that complies with the requirements of Article 20(1) to (15), the aggregate of: (a) where relevant, the amount by which eligible liabilities must be written down in order to ensure that the net asset value of the institution under resolution is equal to zero; and (b) where relevant, the amount by which eligible liabilities must be converted into shares or other types of capital instruments in order to restore the Common Equity Tier 1 capital ratio of either: (i) the institution under resolution; or (ii) the bridge institution. The assessment referred to in the first subparagraph shall establish the amount by which eligible liabilities need to be written down or converted in order to restore the Common Equity Tier 1 capital ratio of the institution under resolution, or, where applicable, establish the ratio of the bridge institution taking into account any contribution of capital by the Fund pursuant to point (d) of Article 76(1), and to sustain sufficient market confidence in the institution under resolution or the bridge institution and enable it to continue to meet, for at least one year, the conditions for authorisation and to continue to carry out the activities for which it is authorised under Directive 2013/36/EU or Directive 2014/65/EU. Where the Board intends to use the asset separation tool referred to in Article 26, the amount by which eligible liabilities need to be reduced shall take into account a prudent estimate of the capital needs of the asset management vehicle as appropriate. 14. Exclusions under paragraph 5 may be applied either to completely exclude a liability from write-down or to limit the extent of the write-down applied to that liability. 15. The write-down and conversion powers shall comply with the requirements on the priority of claims laid down in Article 17 of this Regulation. 16. The national resolution authority shall immediately submit to the Board the business reorganisation plan received in accordance with Article 52(1), (2) and (3) of Directive 2014/59/EU from the management body or the person or persons appointed in accordance with Article 72(1) thereof. Within two weeks from the date of submission of the business reorganisation plan, the relevant national resolution authority shall provide the Board with its assessment of the plan. Within one month from the date of submission of the business reorganisation plan, the Board shall assess the likelihood that the plan, if implemented, will restore the long term viability of an entity referred to in Article 2. The assessment shall be completed in agreement with the national competent authority or the ECB, where relevant. Where the Board is satisfied that the plan would achieve that objective, it shall allow the national resolution authority to approve the plan in accordance with Article 52(7) of Directive 2014/59/EU. Where the Board is not satisfied that the plan would achieve that objective, it shall instruct the national resolution authority to notify the management body or the person or persons appointed in accordance with Article 72(1) of that Directive of its concerns and require the amendment of the plan in a way that addresses those concerns in accordance with Article 52(8) of that Directive. In both cases this shall be done in agreement with the national competent authority or the ECB, where relevant. Within two weeks from the date of receipt of such a notification, the management body or the person or persons appointed in accordance with Article 72(1) of Directive 2014/59/EU shall submit an amended plan to the national resolution authority for approval. The national resolution authority shall submit to the Board the amended plan and its assessment of such plan. The Board shall assess the amended plan, and shall instruct the national resolution authority to notify the management body or the person or persons appointed in accordance with Article 72(1) of Directive 2014/59/EU within one week whether it is satisfied that the plan, as amended, addresses the concerns notified or whether further amendment is required. The Board shall communicate the group business reorganisation plan to EBA. Article 28 Monitoring by the Board 1. The Board shall closely monitor the execution of the resolution scheme by the national resolution authorities. For that purpose, the national resolution authorities shall: (a) cooperate with and assist the Board in the performance of its monitoring duty; (b) provide, at regular intervals established by the Board, accurate, reliable and complete information on the execution of the resolution scheme, the application of the resolution tools and the exercise of the resolution powers, that might be requested by the Board, including on the following: (i) the operation and financial situation of the institution under resolution, the bridge institution and the asset management vehicle; (ii) the treatment that shareholders and creditors would have received in the liquidation of the institution under normal insolvency proceedings; (iii) any ongoing court proceedings relating to the liquidation of the assets of the institution under resolution, to challenges to the resolution decision and to the valuation or relating to applications for compensation filed by the shareholders or creditors; (iv) the appointment, removal or replacement of evaluators, administrators, accountants, lawyers and other professionals that may be necessary to assist the national resolution authority, and on the performance of their duties; (v) any other matter that is relevant for the execution of the resolution scheme including any potential infringement of the safeguards provided for in Directive 2014/59/EU that may be referred to by the Board; (vi) the extent to which, and manner in which, the powers of the national resolution authorities referred to in Articles 63 to 72 of Directive 2014/59/EU are exercised by them; (vii) the economic viability, feasibility, and implementation of the business reorganisation plan provided for in Article 27(16). The national resolution authorities shall submit to the Board a final report on the execution of the resolution scheme. 2. On the basis of the information provided, the Board may give instructions to the national resolution authorities as to any aspect of the execution of the resolution scheme, and in particular the elements referred to in Article 23 and to the exercise of the resolution powers. 3. Where necessary in order to achieve the resolution objectives, the resolution scheme may be amended. The procedure laid down in Article 18 shall apply. Article 29 Implementation of decisions under this Regulation 1. National resolution authorities shall take the necessary action to implement decisions referred to in this Regulation, in particular by exercising control over the entities and groups referred to in Article 7(2), and the entities and groups referred to in Article 7(4)(b) and (5) where the conditions for the application of those paragraphs are met, by taking the necessary measures in accordance with Article 35 or 72 of Directive 2014/59/EU and by ensuring that the safeguards provided for in that Directive are complied with. National resolution authorities shall implement all decisions addressed to them by the Board. For those purposes, subject to this Regulation, they shall exercise their powers under national law transposing Directive 2014/59/EU and in accordance with the conditions laid down in national law. National resolution authorities shall fully inform the Board of the exercise of those powers. Any action they take shall comply with the Board's decisions pursuant to this Regulation. When implementing those decisions, the national resolution authorities shall ensure that the applicable safeguards provided for in Directive 2014/59/EU are complied with. 2. Where a national resolution authority has not applied or has not complied with a decision by the Board pursuant to this Regulation or has applied it in a way which poses a threat to any of the resolution objectives under Article 14 or to the efficient implementation of the resolution scheme, the Board may order an institution under resolution: (a) in the event of action pursuant to Article 18, to transfer to another person specified rights, assets or liabilities of an institution under resolution; (b) in the event of action pursuant to Article 18, to require the conversion of any debt instruments which contain a contractual term for conversion in the circumstances provided for in Article 21; (c) to adopt any other necessary action to comply with the decision in question. The Board shall adopt a decision referred to in point (c) of the first subparagraph only if the measure significantly addresses the threat to the relevant resolution objective or to the efficient implementation of the resolution scheme. Before deciding to impose any measure the Board shall notify the national resolution authorities concerned and the Commission of the measure it intends to take. That notification shall include details of the envisaged measures, the reasons for those measures and details of when the measures are intended to take effect. The notification shall be made not less than 24 hours before the measures are to take effect. In exceptional circumstances where it is not possible to give 24 hours' notice, the Board may make the notification less than 24 hours before the measures are intended to take effect. 3. The institution under resolution shall comply with any decision taken referred to in paragraph 2. Those decisions shall prevail over any previous decision adopted by the national resolution authorities on the same matter. 4. When taking action in relation to issues which are subject to a decision taken pursuant to paragraph 2, national resolution authorities shall comply with that decision. 5. The Board shall publish on its official website either a copy of the resolution scheme or a notice summarising the effects of the resolution action, and in particular the effects on retail customers. The national resolution authorities shall comply with the applicable procedural obligations provided for in Article 83 of Directive 2014/59/EU. CHAPTER 4 Cooperation Article 30 Obligation to cooperate and information exchange within the SRM 1. The Board shall inform the Commission of any action it takes in order to prepare for resolution. With regard to any information received from the Board, the members of the Council, the Commission as well as the Council and the Commission staff shall be subject to the requirements of professional secrecy laid down in Article 88. 2. In the exercise of their respective responsibilities under this Regulation, the Board, the Council, the Commission, the ECB and the national resolution authorities and national competent authorities shall cooperate closely, in particular in the resolution planning, early intervention and resolution phases pursuant to Articles 8 to 29. They shall provide each other with all information necessary for the performance of their tasks. 3. The ECB or the national competent authorities shall transmit to the Board and the national resolution authorities the group financial support agreements authorised and any changes thereto. 4. For the purposes of this Regulation, the ECB may invite the Chair of the Board to participate as an observer in the Supervisory Board of the ECB established in accordance with Article 19 of Regulation (EU) No 1024/2013. Where deemed to be appropriate the Board may appoint another representative to replace the Chair for that purpose. 5. For the purposes of this Regulation, the Board shall appoint a representative which shall participate in the Resolution Committee of EBA established in accordance with Article 127 of Directive 2014/59/EU. 6. The Board shall endeavour to cooperate closely with any public financial assistance facility including the European Financial Stability Facility (EFSF) and the European Stability Mechanism (ESM), in particular in the extraordinary circumstances referred to in Article 27(9) and where such a facility has granted, or is likely to grant, direct or indirect financial assistance to entities established in a participating Member State. 7. Where necessary, the Board shall conclude a memorandum of understanding with the ECB and the national resolution authorities and the national competent authorities describing in general terms how they will cooperate under paragraphs 2 and 4 in the performance of their respective tasks under Union law. The memorandum shall be reviewed on a regular basis and shall be published subject to the requirements of professional secrecy. Article 31 Cooperation within the SRM 1. The Board shall perform its tasks in close cooperation with national resolution authorities. The Board shall, in cooperation with national resolution authorities, approve and make public a framework to organise the practical arrangements for the implementation of this Article. In order to ensure effective and consistent application of this Article, the Board: (a) shall issue guidelines and general instructions to national resolution authorities according to which the tasks are performed and resolution decisions are adopted by national resolution authorities; (b) may at any time exercise the powers referred to in Articles 34 to 37; (c) may request, on an ad hoc or continuous basis, information from national resolution authorities on the performance of the tasks carried out by them under Article 7(3); (d) shall receive from national resolution authorities draft decisions on which it may express its views, and, in particular, indicate the elements of the draft decision that do not comply with this Regulation or with the Board's general instructions. For the purposes of evaluating resolution plans, the Board may request national resolution authorities to submit to the Board all information necessary, as obtained by them in accordance with Article 11 and Article 13(1) of Directive 2014/59/EU, without prejudice to Chapter 5 of this Title. 2. Article 13(4) to (10) and Articles 88 to 92 of Directive 2014/59/EU shall not apply to relations between national resolution authorities. The joint decision and any decision taken in the absence of a joint decision as referred to in Article 45(9) to (13) of Directive 2014/59/EU shall not apply. The relevant provisions of this Regulation shall apply instead. Article 32 Consultation of, and cooperation with, non-participating Member States and third countries 1. Where a group includes entities established in participating Member States as well as in non-participating Member States or third countries, without prejudice to any approval by the Council or the Commission required under this Regulation, the Board shall represent the national resolution authorities of the participating Member States for the purposes of consultation and cooperation with non-participating Member States or third countries in accordance with Articles 7, 8, 12, 13, 16, 18, 55, and 88 to 92 of Directive 2014/59/EU. Where a group includes entities established in participating Member States and subsidiaries established, or significant branches located, in non-participating Member States, the Board shall communicate any plans, decisions or measures referred to in Articles 8, 10, 11, 12 and 13 relevant to the group to the competent authorities and/or the resolution authorities of the non-participating Member State, as appropriate. 2. The Board, the ECB and the resolution authorities and competent authorities of the non-participating Member States shall conclude memoranda of understanding describing in general terms how they will cooperate with one another in the performance of their tasks under Directive 2014/59/EU. Without prejudice to the first subparagraph, the Board shall conclude a memorandum of understanding with the resolution authority of each non-participating Member State that is home to at least one global systemically important institution, identified as such pursuant to Article 131 of Directive 2013/36/EU. 3. Each memorandum shall be reviewed on a regular basis and shall be published subject to the requirements of professional secrecy. 4. The Board shall conclude, on behalf of the national resolution authorities of participating Member States, non-binding cooperation arrangements in line with the EBA framework cooperation arrangements referred to in Article 97(2) of Directive 2014/59/EU. The Board shall notify EBA of any such cooperation arrangement. Article 33 Recognition and enforcement of third-country resolution proceedings 1. This Article shall apply in respect of third-country resolution proceedings unless and until an international agreement as referred to in Article 93(1) of Directive 2014/59/EU enters into force with the relevant third country. It shall also apply following the entry into force of an international agreement as referred to in Article 93(1) of that Directive with the relevant third country to the extent that recognition and enforcement of third-country resolution proceedings is not governed by that agreement. 2. The Board shall assess and issue a recommendation addressed to the national resolution authorities on the recognition and enforcement of resolution proceedings conducted by third-country resolution authorities in relation to a third-country institution or a third-country parent undertaking that has: (a) one or more Union subsidiaries established in one or more participating Member States; or (b) assets, rights or liabilities located in one or more participating Member States or governed by the law of participating Member States. The Board shall conduct its assessment, after consulting the national resolution authorities and, where a European resolution college is established pursuant to Article 89 of Directive 2014/59/EU, with the resolution authorities of non-participating Member States. The assessment shall give due consideration to the interests of each individual participating Member State where a third-country institution or parent undertaking operates, and in particular to the potential impact of the recognition and enforcement of the third-country resolution proceedings on the other parts of the group and the financial stability in those Member States. 3. The Board shall recommend to refuse the recognition or enforcement of the resolution proceedings referred to in paragraph 1, if it considers that: (a) the third-country resolution proceedings would have an adverse effect on financial stability in a participating Member State; (b) creditors, including in particular depositors located or payable in a participating Member State, would not receive the same treatment as third-country creditors and depositors with similar legal rights under the third-country home resolution proceedings; (c) recognition or enforcement of the third-country resolution proceedings would have material fiscal implications for the participating Member State; or (d) the effects of such recognition or enforcement would be contrary to the national law of the participating Member State. 4. National resolution authorities shall implement the recommendation of the Board and ask for the recognition or enforcement of the resolution proceedings in their respective territories, or shall explain in a reasoned statement to the Board why they cannot implement the recommendation of the Board. 5. When exercising resolution powers in relation to third-country entities, national resolution authorities shall, where relevant, exercise the powers conferred on them on the basis of the provisions referred to in Article 94(4) of Directive 2014/59/EU. CHAPTER 5 Investigatory powers Article 34 Requests for information 1. For the purpose of performing its tasks under this Regulation, the Board may, through the national resolution authorities or directly, after informing them, making full use of all of the information available to the ECB or to the national competent authorities, require the following legal or natural persons to provide all of the information necessary to perform the tasks conferred on it by this Regulation: (a) the entities referred to in Article 2; (b) employees of the entities referred to in Article 2; (c) third parties to whom the entities referred to in Article 2 have outsourced functions or activities. 2. The entities and persons referred to in paragraph 1 shall supply the information requested pursuant to that paragraph. The requirements of professional secrecy shall not exempt those entities and persons from the duty to supply that information. The supply of the information requested shall not be deemed to infringe the requirements of professional secrecy. 3. Where the Board obtains information directly from those entities and persons, it shall make that information available to the national resolution authorities concerned. 4. The Board shall be able to obtain, including on a continuous basis, any information necessary for the exercise of its functions under this Regulation, in particular on capital, liquidity, assets and liabilities concerning any institution subject to its resolution powers. 5. The Board, the ECB, the national competent authorities and the national resolution authorities may draw up memoranda of understanding with a procedure concerning the exchange of information. The exchange of information between the Board, the ECB, the national competent authorities and the national resolution authorities shall not be deemed to infringe the requirements of professional secrecy. 6. National competent authorities, the ECB where relevant, and national resolution authorities shall cooperate with the Board in order to verify whether some or all of the information requested is already available. Where such information is available, national competent authorities, the ECB where relevant, or national resolution authorities shall provide that information to the Board. Article 35 General investigations 1. For the purpose of performing its tasks under this Regulation, and subject to any other conditions laid down in relevant Union law, the Board may, through the national resolution authorities or directly, after informing them, conduct all necessary investigations of any legal or natural person referred to in Article 34(1) established or located in a participating Member State. To that end, the Board may: (a) require the submission of documents; (b) examine the books and records of any legal or natural person referred to in Article 34(1) and take copies or extracts from such books and records; (c) obtain written or oral explanations from any legal or natural person referred to in Article 34(1) or their representatives or staff; (d) interview any other natural or legal person who consents to be interviewed for the purpose of collecting information relating to the subject matter of an investigation. 2. The natural or legal persons referred to in Article 34(1) shall be subject to investigations launched on the basis of a decision of the Board. Where a person obstructs the conduct of the investigation, the national resolution authorities of the participating Member State where the relevant premises are located shall afford, in accordance with national law, the necessary assistance including facilitating the access by the Board to the business premises of the natural or legal persons referred to in Article 34(1), so that those rights can be exercised. Article 36 On-site inspections 1. For the purpose of performing its tasks under this Regulation, and subject to other conditions laid down in relevant Union law, the Board may, in accordance with Article 37 and subject to prior notification to the national resolution authorities and the relevant national competent authorities concerned, and, where appropriate, in cooperation with them, conduct all necessary on-site inspections at the business premises of the natural or legal persons referred to in Article 34(1). Where the proper conduct and efficiency of the inspection so require, the Board may carry out the on-site inspection without prior announcement to those legal persons. 2. The officials of and other persons authorised by the Board to conduct an on-site inspection may enter any business premises and land of the legal persons subject to an investigation decision adopted by the Board pursuant to Article 35(2) and shall have all of the powers referred to in Article 35(1). 3. The legal persons referred to in Article 34(1) shall be subject to on-site inspections on the basis of a decision of the Board. 4. Officials of, and other accompanying persons authorised or appointed by, the national resolution authorities of the Member States where the inspection is to be conducted shall, under the supervision and coordination of the Board, actively assist the officials of, and other persons authorised by, the Board. To that end, they shall enjoy the powers referred to in paragraph 2. Officials of, and other accompanying persons authorised or appointed by, the national resolution authorities of the participating Member States concerned shall also have the right to participate in the on-site inspections. 5. Where the officials of and other accompanying persons authorised or appointed by the Board find that a person opposes an inspection ordered pursuant to paragraph 1, the national resolution authorities of the participating Member States concerned shall afford them the necessary assistance in accordance with national law. To the extent necessary for the inspection, that assistance shall include the sealing of any business premises and books or records. Where that power is not available to the national resolution authorities concerned, it shall exercise its powers to request the necessary assistance of other national authorities. Article 37 Authorisation by a judicial authority 1. If an on-site inspection provided for in Article 36(1) and (2) or the assistance provided for in Article 36(5) requires authorisation by a judicial authority in accordance with national rules, such authorisation shall be applied for. 2. Where authorisation as referred to in paragraph 1 of this Article is applied for, the national judicial authority shall control that the decision of the Board is authentic and that the coercive measures envisaged are neither arbitrary nor excessive, taking into account the subject matter of the inspection. In its control of the proportionality of the coercive measures, the national judicial authority may ask the Board for detailed explanations, in particular relating to the grounds the Board has for suspecting that an infringement of the decisions referred to in Article 29 has taken place, the seriousness of the suspected infringement and the nature of the involvement of the person subject to the coercive measures. However, the national judicial authority shall not review the necessity for the inspection or demand to be provided with the information on the Board's file. The lawfulness of the Board's decision shall be subject to review only by the Court of Justice. CHAPTER 6 Penalties Article 38 Fines 1. Where the Board finds that an entity referred to in Article 2 has intentionally or negligently committed one of the infringements listed in paragraph 2, the Board shall take a decision imposing a fine in accordance with paragraph 3. An infringement by such an entity shall be considered to have been committed intentionally if there are objective factors which demonstrate that the entity or its management body or senior management acted deliberately to commit the infringement. 2. The fines shall be imposed on entities referred to in Article 2 for the following infringements: (a) where they do not supply the information requested in accordance with Article 34; (b) where they do not submit to a general investigation in accordance with Article 35 or an on-site inspection in accordance with Article 36; (c) where they do not comply with a decision addressed to them by the Board pursuant to Article 29. 3. The basic amount of the fines referred to in paragraph 1 of this Article shall be a percentage of the total annual net turnover including the gross income consisting of interest receivable and similar income, income from shares and other variable or fixed-yield securities, and commissions or fees receivable in accordance with Article 316 of Regulation (EU) No 575/2013 of the undertaking in the preceding business year, or, in the Member States whose currency is not the euro, the corresponding value in the national currency on 19 August 2014, and included within the following limits: (a) for the infringements referred to in paragraph 2(a) and (b), the basic amount shall amount to at least 0,05 % and shall not exceed 0,15 %; (b) for the infringements referred to in paragraph 2(c), the basic amount shall amount to at least 0,25 % and shall not exceed 0,5 %. In order to decide whether the basic amount of the fines should be set at the lower, the middle or the higher end of the limits referred to in the first subparagraph, the Board shall take into account the annual turnover in the preceding business year of the entity concerned. The basic amount shall be at the lower end of the limit for entities whose annual turnover is below EUR 1 000 000 000, the middle of the limit for the entities whose annual turnover is between EUR 1 000 000 000 and 5 000 000 000 and the higher end of the limit for the entities whose annual turnover is higher than EUR 5 000 000 000. 4. The basic amounts referred to in paragraph 3 shall be adjusted, if necessary, by taking into account the aggravating or mitigating factors referred to in paragraphs 5 and 6, in accordance with the relevant coefficients referred to in paragraph 9. The relevant mitigating coefficient shall be applied one by one to the basic amount. If more than one mitigating coefficient is applicable, the difference between the basic amount and the amount resulting from the application of each individual mitigating coefficient shall be subtracted from the basic amount. The relevant aggravating coefficient shall be applied one by one to the basic amount. If more than one aggravating coefficient is applicable, the difference between the basic amount and the amount resulting from the application of each individual aggravating coefficient shall be added to the basic amount. 5. The following aggravating factors shall apply in respect of the fines referred to in paragraph 1: (a) the infringement has been committed intentionally; (b) the infringement has been committed repeatedly; (c) the infringement has been committed over a period exceeding three months; (d) the infringement has revealed systemic weaknesses in the organisation of the entity, in particular in its procedures, management systems or internal controls; (e) no remedial action has been taken since the infringement was identified; (f) the entity's senior management has not cooperated with the Board in carrying out its investigations. 6. The following mitigating factors shall apply in respect of the fines referred to in paragraph 1: (a) the infringement has been committed over a period of less than 10 working days; (b) the entity's senior management can demonstrate that they have taken all measures necessary to prevent the infringement; (c) the entity has brought quickly, effectively and completely the infringement to the Board's attention; (d) the entity has voluntarily taken measures to ensure that a similar infringement cannot be committed in the future. 7. Notwithstanding paragraphs 2 to 6, the fines applied shall not exceed 1 % of the annual turnover of the entity referred to in paragraph 1 concerned in the preceding business year. By way of derogation from the first subparagraph, where the entity has directly or indirectly benefited financially from that infringement and where profits gained or losses avoided because of the infringement can be determined, the fine shall be at least equal to that financial benefit. Where an act or omission of an entity referred to in paragraph 1 constitutes more than one infringement listed in paragraph 2, only the higher fine calculated in accordance with this Article and relating to one of those infringements shall apply. 8. In the cases not covered by paragraph 2, the Board may recommend to national resolution authorities to take action in order to ensure that appropriate penalties are imposed in accordance with Articles 110 to 114 of Directive 2014/59/EU and with any relevant national legislation. 9. The Board shall apply the following adjustment coefficients linked to aggravating factors when calculating the fines: (a) if the infringement has been committed repeatedly, for every time it has been repeated, an additional coefficient of 1,1 shall apply; (b) if the infringement has been committed over a period exceeding three months, a coefficient of 1,5 shall apply; (c) if the infringement has revealed systemic weaknesses in the organisation of the entity, in particular in its procedures, management systems or internal controls, a coefficient of 2,2 shall apply; (d) if the infringement has been committed intentionally, a coefficient of 2 shall apply; (e) if no remedial action has been taken since the infringement was identified, a coefficient of 1,7 shall apply; (f) if the entity's senior management has not cooperated with the Board in carrying out its investigations, a coefficient of 1,5 shall apply. The Board shall apply the following adjustment coefficients linked to mitigating factors when calculating the fines: (a) if the infringement has been committed over a period of less than 10 working days, a coefficient of 0,9 shall apply; (b) if the entity's senior management can demonstrate that they have taken all measures necessary to prevent the infringement, a coefficient of 0,7 shall apply; (c) if the entity has brought quickly, effectively and completely the infringement to the Board's attention, a coefficient of 0,4 shall apply; (d) if the entity has voluntarily taken measures to ensure that a similar infringement cannot be committed in the future, a coefficient of 0,6 shall apply. Article 39 Periodic penalty payments 1. The Board shall, by a decision, impose a periodic penalty payment in respect of an entity referred to in Article 2 in order to compel: (a) that entity to comply with a decision adopted under Article 34; (b) a person referred to in Article 34(1) to supply complete information which has been required by a decision pursuant to that Article; (c) a person referred to in Article 35(1) to submit to an investigation and, in particular, to produce complete records, data, procedures or any other material required and to complete and correct other information provided in an investigation launched by a decision taken pursuant to that Article; (d) a person referred to in Article 36(1) to submit to an on-site inspection ordered by a decision taken pursuant to that Article. 2. A periodic penalty payment shall be effective and proportionate. A periodic penalty payment shall be imposed on a daily basis until the entity referred to in Article 2 or person concerned complies with the relevant decisions referred to in points (a) to (d) of paragraph 1 of this Article. 3. Notwithstanding paragraph 2, the amount of a periodic penalty payment shall be 0,1 % of the average daily turnover in the preceding business year. A periodic penalty payment shall be calculated from the date stipulated in the decision imposing the periodic penalty payment. 4. A periodic penalty payment may be imposed for a period of no more than six months following the notification of the Board's decision. Article 40 Hearing of the persons subject to the proceedings 1. Before taking any decision imposing a fine and/or periodic penalty payment under Article 38 or 39, the Board shall give the natural or legal persons subject to the proceedings the opportunity to be heard on its findings. The Board shall base its decisions only on findings on which the natural or legal persons subject to the proceedings have had the opportunity to comment. 2. The rights of defence of the natural or legal persons subject to the proceedings shall be fully complied with during the proceedings. They shall be entitled to have access to the Board's file, subject to the legitimate interest of other persons in the protection of their business secrets. The right of access to the file shall not extend to confidential information or internal preparatory documents of the Board. Article 41 Disclosure, nature, enforcement and allocation of fines and periodic penalty payments 1. The Board shall publish the decisions imposing penalties referred to in Article 38(1) and Article 39(1), unless such disclosure could endanger the resolution of the entity concerned. The publication shall be on an anonymous basis, in any of the following circumstances: (a) where the information published contains personal data and following an obligatory prior assessment, such publication of personal data is found to be disproportionate; (b) where publication would jeopardise the stability of financial markets or an ongoing criminal investigation; (c) where publication would cause, insofar as it can be determined, disproportionate damage to the natural or legal persons involved. Alternatively, in such cases, the publication of the data in question may be postponed for a reasonable period if it is foreseeable that the reasons for anonymous publication will cease to exist within that period. The Board shall inform EBA of all fines and periodic penalty payments imposed by it under Articles 38 and 39 and shall provide information on the appeal status and outcome thereof. 2. Fines and periodic penalty payments imposed pursuant to Articles 38 and 39 shall be of an administrative nature. 3. Fines and periodic penalty payments imposed pursuant to Articles 38 and 39 shall be enforceable. Enforcement shall be governed by the applicable procedural rules in force in the participating Member State in the territory of which it is carried out. The order for its enforcement shall be appended to the decision without any other formality than verification of the authenticity of the decision by the authority which the government of each participating Member State shall designate for that purpose and which it shall make known to the Board and to the Court of Justice. When those formalities have been completed on application by the party concerned, the latter may proceed to enforcement in accordance with the national law, by bringing the matter directly before the competent body. Enforcement may be suspended only by a decision of the Court of Justice. However, the courts of the participating Member State concerned shall have jurisdiction over complaints that enforcement is being carried out in an irregular manner. 4. The amounts of the fines and periodic penalty payments shall be allocated to the Fund. PART III INSTITUTIONAL FRAMEWORK TITLE I THE BOARD Article 42 Legal status 1. The Board is hereby established. The Board shall be a Union agency with a specific structure corresponding to its tasks. It shall have legal personality. 2. In each Member State, the Board shall enjoy the most extensive legal capacity accorded to legal persons under national law. It may, in particular, acquire or dispose of movable and immovable property and be a party to legal proceedings. 3. The Board shall be represented by its Chair. Article 43 Composition 1. The Board shall be composed of: (a) the Chair appointed in accordance with Article 56; (b) four further full-time members appointed in accordance with Article 56; (c) a member appointed by each participating Member State, representing their national resolution authorities. 2. Each member, including the Chair, shall have one vote. 3. The Commission and the ECB shall each designate a representative entitled to participate in the meetings of executive sessions and plenary sessions as a permanent observer. The representatives of the Commission and the ECB shall be entitled to participate in the debates and shall have access to all documents. 4. In the event of more than one national resolution authority in a participating Member State, a second representative shall be allowed to participate as observer without voting rights. 5. The Board's administrative and management structure shall comprise: (a) a plenary session of the Board, which shall perform the tasks referred to in Article 50; (b) an executive session of the Board, which shall perform the tasks referred to in Article 54; (c) a Chair, which shall perform the tasks referred to in Article 56; (d) a Secretariat, which shall provide the necessary administrative and technical support on the performing of all the tasks assigned to the Board. Article 44 Compliance with Union law The Board shall act in compliance with Union law, in particular with the Council and the Commission decisions pursuant to this Regulation. Article 45 Accountability 1. The Board shall be accountable to the European Parliament, the Council and the Commission for the implementation of this Regulation, in accordance with paragraphs 2 to 8. 2. The Board shall submit an annual report to the European Parliament, the national parliaments of participating Member States in accordance with Article 46, the Council, the Commission and the European Court of Auditors on the performance of the tasks conferred on it by this Regulation. Subject to the requirements of professional secrecy, that report shall be published on the Board's website. 3. The Chair shall present that report in public to the European Parliament, and to the Council. 4. At the request of the European Parliament, the Chair shall participate in a hearing by the competent committee of the European Parliament on the performance of the resolution tasks by the Board. A hearing shall take place at least annually. 5. The Chair may be heard by the Council, at the Council's request, on the performance of the resolution tasks by the Board. 6. The Board shall reply orally or in writing to questions addressed to it by the European Parliament or by the Council, in accordance with its own procedures and in any event within five weeks of receipt of a question. 7. Upon request, the Chair shall hold confidential oral discussions behind closed doors with the Chair and Vice-Chairs of the competent committee of the European Parliament where such discussions are required for the exercise of the European Parliament's powers under the TFEU. An agreement shall be concluded between the European Parliament and the Board on the detailed modalities of organising such discussions, with a view to ensuring full confidentiality in accordance with the requirements of professional secrecy imposed on the Board by this Regulation and when the Board is acting as a national resolution authority under the relevant Union law. 8. During any investigations by the European Parliament, the Board shall cooperate with the European Parliament, subject to the TFEU and regulations referred to in Article 226 thereof. Within six months of the appointment of the Chair, the Board and the European Parliament shall conclude appropriate arrangements on the practical modalities of the exercise of democratic accountability and oversight over the exercise of the tasks conferred on the Board by this Regulation. Subject to the power of the European Parliament pursuant to Article 226 TFEU, those arrangements shall cover, inter alia, access to information, including rules on the handling and protection of classified or otherwise confidential information, cooperation in hearings, as referred to in Article 45(4) of this Regulation, confidential oral discussions, reports, responding to questions, investigations and information on the selection procedure of the Chair, the Vice-Chair, and the four members referred to in Article 43(1)(b) of this Regulation. Article 46 National parliaments 1. Due to the specific tasks that are conferred on the Board by this Regulation, national parliaments of the participating Member States, by means of their own procedures, may request the Board to reply and the Board is obliged to reply in writing to any observations or questions submitted by them to the Board in respect of the functions of the Board under this Regulation. 2. When submitting the report provided for in Article 45(2), the Board shall simultaneously submit that report directly to the national parliaments of the participating Member States. National parliaments may address to the Board their reasoned observations on that report. The Board shall reply orally or in writing to any observations or questions addressed to it by the national parliaments of the participating Member States, in accordance with its own procedures. 3. The national parliament of a participating Member State may invite the Chair to participate in an exchange of views in relation to the resolution of entities referred to in Article 2 in that Member State together with a representative of the national resolution authority. The Chair is obliged to follow such invitation. 4. This Regulation shall be without prejudice to the accountability of national resolution authorities to national parliaments in accordance with national law for the performance of tasks not conferred on the Board, the Council or the Commission by this Regulation and for the performance of activities carried out by them in accordance with Article 7(3). Article 47 Independence 1. When performing the tasks conferred on them by this Regulation, the Board and the national resolution authorities shall act independently and in the general interest. 2. The Chair, the Vice-Chair and the members referred to in Article 43(1)(b) shall perform their tasks in conformity with the decisions of the Board, the Council and the Commission. They shall act independently and objectively in the interest of the Union as a whole and shall neither seek nor take instructions from the Union's institutions or bodies, from any government of a Member State or from any other public or private body. In the deliberations and decision-making processes within the Board, they shall express their own views and vote independently. 3. Neither the Member States, the Union's institutions or bodies, nor any other public or private body shall seek to influence the Chair, the Vice-Chair or the members of the Board. 4. In accordance with the Staff Regulations of Officials as laid down by Council Regulation (EEC, Euratom, ECSC) No 259/68 (19) (the ‘Staff Regulations’) referred to in Article 87(6) of this Regulation, the Chair, the Vice-Chair and the members referred to in Article 43(1)(b) of this Regulation shall, after leaving service, continue to be bound by the duty to behave with integrity and discretion as regards the acceptance of certain appointments or benefits. Article 48 Seat The Board shall have its seat in Brussels, Belgium. TITLE II PLENARY SESSION OF THE BOARD Article 49 Participation in plenary sessions All members of the Board referred to in Article 43(1) shall participate in its plenary sessions. Article 50 Tasks 1. In its plenary session, the Board shall: (a) adopt, by 30 November each year, the Board's annual work programme for the following year, based on a draft put forward by the Chair and shall transmit it for information to the European Parliament, the Council, the Commission, and the ECB; (b) adopt and monitor the annual budget of the Board in accordance with Article 61(2), and approve the Board's final accounts and give discharge to the Chair in accordance with Article 63(4) and (8); (c) subject to the procedure referred to in paragraph 2, decide on the use of the Fund, if the support of the Fund in that specific resolution action is required above the threshold of EUR 5 000 000 000 for which the weighting of liquidity support is 0,5; (d) once the net accumulated use of the Fund in the last consecutive 12 months reaches the threshold of EUR 5 000 000 000, evaluate the application of the resolution tools, in particular the use of the Fund, and provide guidance which the executive session shall follow in subsequent resolution decisions, in particular, if appropriate, differentiating between liquidity and other forms of support; (e) decide on the necessity to raise extraordinary ex-post contributions in accordance with Article 71, on the voluntary borrowing between financing arrangements in accordance with Article 72, on alternative financing means in accordance with Articles 73 and 74, and on the mutualisation of national financing arrangements in accordance with Article 78, involving support of the Fund above the threshold referred to in point (c) of this paragraph; (f) decide on the investments in accordance with Article 75; (g) adopt the annual activity report on the Board's activities referred to in Article 45, which shall present detailed explanations on the implementation of the budget; (h) adopt the financial rules applicable to the Board in accordance with Article 64; (i) adopt an anti-fraud strategy, proportionate to fraud risks taking into account the costs and benefits of the measures to be implemented; (j) adopt rules for the prevention and management of conflicts of interest in respect of its members; (k) adopt its rules of procedure and those of the Board in its executive session; (l) in accordance with paragraph 3 of this Article, exercise, with respect to the staff of the Board, the powers conferred by the Staff Regulations on the Appointing Authority and by the Conditions of Employment of Other Servants of the European Union as laid down by Council Regulation (EEC, Euratom, ECSC) No 259/68 (‘Conditions of Employment’) on the Authority Empowered to Conclude a Contract of Employment (‘the appointing authority powers’); (m) adopt appropriate implementing rules for giving effect to the Staff Regulations and the Conditions of Employment in accordance with Article 110 of the Staff Regulations; (n) appoint an Accounting Officer, subject to the Staff Regulations and the Conditions of Employment, who shall be functionally independent in the performance of his or her duties; (o) ensure adequate follow-up to findings and recommendations stemming from the internal or external audit reports and evaluations, as well as from investigations of the European Anti-Fraud Office (OLAF); (p) take all decisions on the establishment of the Board's internal structures and, where necessary, their modification; (q) approve the framework referred to in Article 31(1) to organise the practical arrangements for the cooperation with the national resolution authorities. 2. When taking decisions, the plenary session of the Board shall act in accordance with the objectives as specified in Articles 6 and 14. For the purposes of point (c) of paragraph 1, the resolution scheme prepared by the executive session is deemed to be adopted unless, within three hours from the submission of the draft by the executive session to the plenary session, at least one member of the plenary session has called a meeting of the plenary session. In the latter case, a decision on the resolution scheme shall be taken by the plenary session. 3. In its plenary session, the Board shall adopt, in accordance with Article 110 of the Staff Regulations, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment, delegating relevant appointing authority powers to the Chair and establishing the conditions under which the delegation of powers can be suspended. The Chair shall be authorised to sub-delegate those powers. In exceptional circumstances, the Board in its plenary session may by way of a decision temporarily suspend the delegation of the appointing authority powers to the Chair and any sub-delegation by the latter and exercise them itself or delegate them to one of its members or to a staff member other than the Chair. Article 51 Meeting of the plenary session of the Board 1. The Chair shall convene and chair meetings of the plenary session of the Board in accordance with Article 56(2)(a). 2. The Board in its plenary session shall hold at least two ordinary meetings per year. In addition, it shall meet on the initiative of the Chair, or at the request of at least one-third of its members. The representative of the Commission may request the Chair to convene a meeting of the Board in its plenary session. The Chair shall provide reasons in writing if he or she does not convene a meeting in due time. 3. Where relevant, the Board may invite observers in addition to those referred in Article 43(3) to participate in the meetings of its plenary session on an ad hoc basis, including a representative of EBA. 4. The Board shall provide for the secretariat of the plenary session of the Board. Article 52 General provisions on the decision-making process 1. The Board, in its plenary session, shall take its decisions by a simple majority of its members, unless otherwise provided for in this Regulation. Each voting member shall have one vote. In the event of a tie, the Chair shall have a casting vote. 2. By way of derogation from paragraph 1, decisions referred to in Article 50(1)(c) and (d) as well as on the mutualisation of national financing arrangements in accordance with Article 78, limited to the use of the financial means available in the Fund, shall be taken by a simple majority of the Board members, representing at least 30 % of contributions. Each voting member shall have one vote. In the event of a tie, the Chair shall have a casting vote. 3. By way of derogation from paragraph 1 of this Article, decisions referred to in Article 50(1), which involve the raising of ex-post contributions in accordance with Article 71, on voluntary borrowing between financing arrangements in accordance with Article 72, on alternative financing means in accordance with Article 73 and Article 74, as well as on the mutualisation of national financing arrangements in accordance with Article 78, exceeding the use of the financial means available in the Fund, shall be taken by a majority of two thirds of the Board members, representing at least 50 % of contributions during the eight-year transitional period until the Fund is fully mutualised and by a majority of two thirds of the Board members, representing at least 30 % of contributions from then on. Each voting member shall have one vote. In the event of a tie, the Chair shall have a casting vote. 4. The Board shall adopt and make public its rules of procedure. The rules of procedure shall establish more detailed voting arrangements, in particular the circumstances in which a member may act on behalf of another member and including, where appropriate, the rules governing quorums. TITLE III EXECUTIVE SESSION OF THE BOARD Article 53 Participation in the executive sessions 1. The Board in its executive session is composed of the Chair and the four members referred to in Article 43(1)(b). The Board, in its executive session, shall meet as often as necessary. Meetings of the Board in its executive session shall be convened by the Chair on his or her own initiative or at the request of any of the members, and shall be chaired by the Chair. Where relevant, the Board in its executive session may invite observers in addition to those referred to in Article 43(3), including a representative of EBA, and shall invite national resolution authorities of non-participating Member States, when deliberating on a group that has subsidiaries or significant branches in those non-participating Member States, to participate at its meetings. The participation shall be on an ad hoc basis. 2. In accordance with paragraphs 3 and 4, the members of the Board referred to in Article 43(1)(c) shall participate in the executive sessions of the Board. 3. When deliberating on an entity referred to in Article 2 or a group of entities established only in one participating Member State, the member appointed by that Member State shall also participate in the deliberations and in the decision-making process, and the rules laid down in Article 55(1) shall apply. 4. When deliberating on a cross-border group, the member appointed by the Member State in which the group-level resolution authority is situated, as well as the members appointed by the Member States in which a subsidiary or entity covered by consolidated supervision is established, shall also participate in the decision-making process, and the rules laid down in Article 55(2) shall apply. 5. The members of the Board referred to in Article 43(1)(a) and (b) shall ensure that the resolution decisions and actions, in particular with regard to the use of the Fund, across the different formations of the executive sessions of the Board are coherent, appropriate and proportionate. Article 54 Tasks 1. The Board, in its executive session, shall: (a) prepare all of the decisions to be adopted by the Board in its plenary session; (b) take all of the decisions to implement this Regulation, unless this Regulation provides otherwise. 2. In exercising its duties pursuant to paragraph 1 of this Article, the Board shall: (a) prepare, assess and approve resolution plans for entities and groups referred to in Article 7(2), and for the entities and groups referred to in Article 7(4)(b) and (5), where the conditions for the application of those paragraphs are met, in accordance with Articles 8, 10 and 11; (b) apply simplified obligations to certain entities and groups referred to in Article 7(2), and entities and groups referred to in Article 7(4)(b) and (5), where the conditions for the application of those paragraphs are met, in accordance with Article 11; (c) determine the minimum requirement for own funds and eligible liabilities that entities and groups referred to in Article 7(2), and entities and groups referred to in Article 7(4)(b) and (5), where the conditions for the application of those paragraphs are met, need to meet at all times in accordance with Article 12; (d) provide the Commission, as early as possible, with a resolution scheme in accordance with Article 18 accompanied by all relevant information allowing in due time the Commission to assess and decide or, where appropriate, propose a decision to the Council, pursuant to Article 18(7); (e) decide upon the Board's part II of the budget on the Fund, in accordance with Article 60. 3. Where necessary because of urgency, the Board in its executive session may take certain provisional decisions on behalf of the Board in its plenary session, in particular on administrative management matters, including budgetary matters. 4. The Board in its executive session shall keep the Board in its plenary session informed of the decisions it takes on resolution. Article 55 Decision-making 1. When deliberating on an individual entity or a group established only in one participating Member State, if all members referred to in Article 53(1) and (3) are not able to reach a joint agreement by consensus within a deadline set by the Chair, the Chair and the members referred to in Article 43(1)(b) shall take a decision by a simple majority. 2. When deliberating on a cross-border group, if all members referred to in Article 53(1) and (4) are not able to reach a joint agreement by consensus within a deadline set by the Chair, the Chair and the members referred to in Article 43(1)(b) shall take a decision by a simple majority. 3. In the event of a tie, the Chair shall have a casting vote. TITLE IV CHAIR Article 56 Appointment and tasks 1. The Board shall be chaired by a full-time Chair. 2. The Chair shall be responsible for: (a) preparing the work of the Board, in its plenary and executive sessions, and convening and chairing its meetings; (b) all staff matters; (c) matters of day-to-day administration; (d) the establishment of a draft budget of the Board in accordance with Article 61(1) and the implementation of the budget of the Board, in accordance with Article 63; (e) the management of the Board; (f) the implementation of the annual work programme of the Board; (g) the preparation, each year, of a draft of the annual report referred to in Article 45 with a section on the resolution activities of the Board and a section on financial and administrative matters. In the performance of the tasks referred to in this Article, the Chair shall be assisted by a dedicated staff. 3. The Chair shall be assisted by a Vice-Chair. The Vice-Chair shall carry out the functions of the Chair in his or her absence or reasonable impediment, in accordance with this Regulation. 4. The Chair, the Vice-Chair and the members referred to in Article 43(1)(b) shall be appointed on the basis of merit, skills, knowledge of banking and financial matters, and of experience relevant to financial supervision, regulation as well as bank resolution. The Chair, the Vice-Chair and the members referred to in Article 43(1)(b) shall be chosen on the basis of an open selection procedure, which shall respect the principles of gender balance, experience and qualification. The European Parliament and the Council shall be kept duly informed at every stage of that procedure in a timely manner. 5. The term of office of the Chair, of the Vice-Chair and of the members referred to in Article 43(1)(b) shall be five years. Subject to paragraph 7 of this Article, that term shall not be renewable. The Chair, the Vice-Chair and the members referred to in Article 43(1)(b) shall not hold office at national, Union, or international level. 6. After hearing the Board, in its plenary session, the Commission shall provide to the European Parliament a shortlist of candidates for the positions of Chair, Vice-Chair and members referred to in Article 43(1)(b) and inform the Council of the shortlist. By way of derogation from the first subparagraph, for the appointment of the first members of the Board following the entry into force of this Regulation, the Commission shall provide the shortlist of candidates without hearing the Board. The Commission shall submit a proposal for the appointment of the Chair, the Vice-Chair and the members referred to in Article 43(1)(b) to the European Parliament for approval. Following the approval of that proposal, the Council shall adopt an implementing decision to appoint the Chair, the Vice-Chair and the members referred to in Article 43(1)(b). The Council shall act by qualified majority. 7. By way of derogation from paragraph 5, the term of office of the first Chair appointed after the entry into force of this Regulation shall be three years. That term shall be renewable once for a period of five years. The Chair, the Vice-Chair, and the members referred to in Article 43(1)(b) shall remain in office until their successors are appointed. 8. A Chair whose term of office has been extended shall not participate in another selection procedure for the same post at the end of the overall period. 9. If the Chair or the Vice-Chair or a member referred to in Article 43(1)(b) no longer fulfil the conditions required for the performance of his or her duties or has been guilty of serious misconduct, the Council may, on a proposal from the Commission which has been approved by the European Parliament, adopt an implementing decision to remove him or her from office. The Council shall act by qualified majority. For those purposes, the European Parliament or the Council may inform the Commission that it considers the conditions for the removal of the Chair, the Vice-Chair or the members referred to in Article 43(1)(b) from office to be fulfilled, to which the Commission shall respond. TITLE V FINANCIAL PROVISIONS CHAPTER 1 General provisions Article 57 Resources 1. The Board shall be responsible for devoting the necessary financial and human resources to the performance of the tasks conferred on it by this Regulation. 2. The funding of the Board's budget or its resolution activities under this Regulation may under no circumstances engage the budgetary liability of the Member States. Article 58 Budget 1. The Board shall have an autonomous budget which is not part of the Union budget. Estimates of all of the Board's revenue and expenditure shall be prepared for each financial year, corresponding to the calendar year, and shall be shown in the Board's budget. 2. The Board's budget shall be balanced in terms of revenue and expenditure. 3. The budget shall comprise two parts: Part I for the administration of the Board and Part II for the Fund. Article 59 Part I of the budget on the administration of the Board 1. The revenues of Part I of the budget shall consist of the annual contributions necessary to cover the annual estimated administrative expenditure. 2. The expenditure of Part I of the budget shall include at least staff, remuneration, administrative, infrastructure, professional training and operational expenses. 3. This Article is without prejudice to the right of the national resolution authorities to levy fees in accordance with national law, in respect of their administrative expenditures of the types referred to in paragraphs 1 and 2, including expenditures for cooperating with and assisting the Board. Article 60 Part II of the budget on the Fund 1. The revenues of Part II of the budget shall consist, in particular, of the following: (a) contributions paid by institutions established in the participating Member States in accordance with Article 67(4) and Articles 69, 70 and 71; (b) loans received from other resolution financing arrangements in non-participating Member States in accordance with Article 72(1); (c) loans received from financial institutions or other third parties in accordance with Articles 73 and 74; (d) returns on the investments of the amounts held in the Fund in accordance with Article 75; (e) any part of the expenses incurred for the purposes indicated in Article 76 which are recovered in the resolution proceedings. 2. The expenditure of Part II of the budget shall consist of the following: (a) expenses for the purposes indicated in Article 76; (b) investments in accordance with Article 75; (c) interest paid on loans received from other resolution financing arrangements in non-participating Member States in accordance with Article 72(1); (d) interest paid on loans received from financial institutions or other third parties in accordance with Articles 73 and 74. Article 61 Establishment and implementation of the budget 1. By 15 February each year, the Chair shall draw up a draft budget of the Board, including a statement of estimates of the Board's revenue and expenditure for the following year together with the establishment plan and shall submit it to the Board for adoption. 2. By 31 March each year, the Board in its plenary session shall, where necessary, adjust the draft submitted by the Chair and adopt the final budget of the Board together with the establishment plan. Article 62 Internal audit and control 1. An internal audit function shall be set up within the Board, to be performed in compliance with the relevant international standards. The internal auditor, appointed by the Board, shall be responsible to it for verifying the proper operation of budget implementation systems and budgetary procedures of the Board. 2. The internal auditor shall advise the Board on dealing with risks, by issuing independent opinions on the quality of management and control systems and by issuing recommendations for improving the conditions of implementation of operations and promoting sound financial management. 3. The responsibility for putting in place internal control systems and procedures suitable for performing the tasks of the internal auditor shall lie with the Board. Article 63 Implementation of the budget, presentation of accounts and discharge 1. The Chair shall act as authorising officer and shall implement the Board's budget. 2. By 1 March of the following financial year, the Board's Accounting Officer shall send the provisional accounts, accompanied by the report on budgetary and financial management during the financial year, to the Court of Auditors for observations. By 31 March of the following financial year, the Board's Accounting Officer shall submit the report on budgetary and financial management to the members of the Board, and to the European Parliament, the Council and the Commission. 3. By 31 March each year, the Chair shall transmit to the European Parliament, the Council and the Commission the Board's provisional accounts for the preceding financial year. 4. On receipt of the Court of Auditors' observations on the Board's provisional accounts, the Chair, acting on his or her own responsibility, shall draw up the Board's final accounts and shall send them to the Board in its plenary session, for approval. 5. The Chair shall, following the approval by the Board, by 1 July each year, send the final accounts for the preceding financial year to the European Parliament, the Council, the Commission, and the Court of Auditors. 6. Where observations are received from the Court of Auditors, the Chair shall send a reply by 30 September. 7. By 15 November each year, the final accounts for the preceding financial year shall be published in the Official Journal of the European Union. 8. The Board, in its plenary session, shall give discharge to the Chair in respect of the implementation of the budget. 9. The Chair shall submit at the request of either the European Parliament or the Council, any information referred to in the Board's accounts to the requesting Union institution, subject to the requirements of professional secrecy laid down in this Regulation. Article 64 Financial rules The Board shall, after consulting the Court of Auditors and the Commission, adopt internal financial provisions specifying, in particular, the detailed procedure for establishing and implementing its budget in accordance with Articles 61 and 63. As far as is compatible with the particular nature of the Board, the financial provisions shall be based on the framework financial Regulation adopted for bodies set up under the TFEU in accordance with Article 208 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (20). Article 65 Contributions to the administrative expenditures of the Board 1. Entities referred to in Article 2 shall contribute to part I of the budget of the Board in accordance with this Regulation and the delegated acts on contributions adopted pursuant to paragraph 5 of this Article. 2. The amounts of the contributions shall be fixed at such a level as to ensure that the revenue in respect thereof is in principle sufficient for part I of the budget of the Board to be balanced each year. 3. The Board shall determine and raise, in accordance with the delegated acts referred to in paragraph 5 of this Article, the contributions due by each entity referred to in Article 2 in a decision addressed to the entity concerned. The Board shall apply procedural, reporting and other rules ensuring that contributions are paid fully and in a timely manner. 4. The amounts raised in accordance with paragraphs 1, 2, 3 shall be used only for the purposes of this Regulation. 5. The Commission shall be empowered to adopt delegated acts on contributions in accordance with Article 93 in order to: (a) determine the type of contributions and the matters for which contributions are due, the manner in which the amount of the contributions is calculated, and the way in which they are to be paid; (b) specify registration, accounting, reporting and other rules referred to in paragraph 3 necessary to ensure that the contributions are paid fully and in a timely manner; (c) determine the annual contributions necessary to cover the administrative expenditure of the Board before it becomes fully operational. Article 66 Anti-fraud measures 1. For the purposes of combating fraud, corruption and any other unlawful activity under Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (21), within six months from the day the Board becomes operational, it shall accede to the Interinstitutional Agreement of 25 May 1999 concerning internal investigations by OLAF and shall immediately adopt appropriate provisions applicable to all staff of the Board using the template set out in the Annex to that Interinstitutional Agreement. 2. The Court of Auditors shall have the power of audit, on the basis of documents and on the spot, over the beneficiaries, contractors and subcontractors who have received funds from the Board. 3. OLAF may carry out investigations, including on-the-spot checks and inspections with a view to establishing whether there has been fraud, corruption or other illegal activity affecting the financial interests of the Union in connection with a contract funded by the Board in accordance with the provisions and procedures laid down in Council Regulation (Euratom, EC) No 2185/96 (22) and Regulation (EU, Euratom) No 883/2013. CHAPTER 2 The Single Resolution Fund Section 1 Constitution of the Fund Article 67 General provisions 1. The Single Resolution Fund (‘the Fund’) is hereby established. It shall be filled in accordance with the rules on transferring the funds raised at national level towards the Fund as laid down in the Agreement. 2. The Board shall use the Fund only for the purpose of ensuring the efficient application of the resolution tools and exercise of the resolution powers referred to in Part II, Title I and in accordance with the resolution objectives and the principles governing resolution referred to in Articles 14 and 15. Under no circumstances shall the Union budget or the national budgets be held liable for expenses or losses of the Fund. 3. The owner of the Fund shall be the Board. 4. Contributions referred to in Articles 69, 70 and 71 shall be raised from entities referred to in Article 2 by the national resolution authorities and transferred to the Fund in accordance with the Agreement. Article 68 Requirement to establish resolution financing arrangements Participating Member States shall establish financing arrangements in accordance with Article 100 of Directive 2014/59/EU and with this Regulation. Article 69 Target level 1. By the end of an initial period of eight years from 1 January 2016 or, otherwise, from the date on which this paragraph is applicable by virtue of Article 99(6), the available financial means of the Fund shall reach at least 1 % of the amount of covered deposits of all credit institutions authorised in all of the participating Member States. 2. During the initial period referred to in paragraph 1, contributions to the Fund calculated in accordance with Article 70, and raised in accordance with Article 67(4), shall be spread out in time as evenly as possible until the target level is reached, but with due account of the phase of the business cycle and the impact that pro-cyclical contributions may have on the financial position of contributing institutions. 3. The Board shall extend the initial period referred to in paragraph 1 for a maximum of four years in the event that the Fund has made cumulative disbursements in excess of 0,5 % of the total amount of covered deposits referred to in paragraph 1 and where the criteria of the delegated act referred in paragraph 5(b) are met. 4. If, after the initial period referred to in paragraph 1, the available financial means diminish below the target level specified in that paragraph, the regular contributions calculated in accordance with Article 70 shall be raised until the target level is reached. After the target level has been reached for the first time and where the available financial means have subsequently been reduced to less than two-thirds of the target level, those contributions shall be set at a level allowing for reaching the target level within six years. The regular contribution shall take due account of the phase of the business cycle, and the impact pro-cyclical contributions may have when setting annual contributions in the context of this paragraph. 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 93 to specify the following: (a) criteria for the spreading out in time of the contributions to the Fund calculated under paragraph 2; (b) criteria for determining the number of years by which the initial period referred to in paragraph 1 can be extended under paragraph 3; (c) criteria for establishing the annual contributions provided for in paragraph 4. Article 70 Ex-ante contributions 1. The individual contribution of each institution shall be raised at least annually and shall be calculated pro-rata to the amount of its liabilities (excluding own funds) less covered deposits, with respect to the aggregate liabilities (excluding own funds) less covered deposits, of all of the institutions authorised in the territories of all of the participating Member States. 2. Each year, the Board shall, after consulting the ECB or the national competent authority and in close cooperation with the national resolution authorities, calculate the individual contributions to ensure that the contributions due by all of the institutions authorised in the territories of all of the participating Member States shall not exceed 12,5 % of the target level. Each year the calculation of the contributions for individual institutions shall be based on: (a) a flat contribution, that is pro-rata based on the amount of an institution's liabilities excluding own funds and covered deposits, with respect to the total liabilities, excluding own funds and covered deposits, of all of the institutions authorised in the territories of the participating Member States; and (b) a risk-adjusted contribution, that shall be based on the criteria laid down in Article 103(7) of Directive 2014/59/EU, taking into account the principle of proportionality, without creating distortions between banking sector structures of the Member States. The relation between the flat contribution and the risk-adjusted contributions shall take into account a balanced distribution of contributions across different types of banks. In any case, the aggregate amount of individual contributions by all of the institutions authorised in the territories of all of the participating Member States, calculated under points (a) and (b), shall not exceed annually the 12,5 % of the target level. 3. The available financial means to be taken into account in order to reach the target level specified in Article 69 may include irrevocable payment commitments which are fully backed by collateral of low-risk assets unencumbered by any third-party rights, at the free disposal of and earmarked for the exclusive use by the Board for the purposes specified in Article 76(1). The share of those irrevocable payment commitments shall not exceed 30 % of the total amount of contributions raised in accordance with this Article. 4. The duly received contributions of each entity referred to in Article 2 shall not be reimbursed to those entities. 5. Where participating Member States have already established national resolution financing arrangements, they may provide that those arrangements use their available financial means, collected from institutions between 17 June 2010 and the date of entry into force of Directive 2014/59/EU, to compensate institutions for the ex-ante contributions which those institutions may be required to pay into the Fund. Such restitution shall be without prejudice to the obligations of Member States laid down in Directive 2014/49/EU. 6. The delegated acts specifying the notion of adjusting contributions in proportion to the risk profile of institutions, adopted by the Commission under Article 103(7) of Directive 2014/59/EU, shall be applied. 7. The Council, acting on a proposal from the Commission, shall, within the framework of the delegated acts referred to in paragraph 6, adopt implementing acts to determine the conditions of implementation of paragraphs 1, 2, and 3, and in particular in relation to: (a) the application of the methodology for the calculation of individual contributions; (b) the practical modalities for allocating to institutions the risk factors specified in the delegated act. Article 71 Extraordinary ex-post contributions 1. Where the available financial means are not sufficient to cover the losses, costs or other expenses incurred by the use of the Fund in resolution actions, extraordinary ex-post contributions from the institutions authorised in the territories of participating Member States shall be raised, in order to cover the additional amounts. Those extraordinary ex-post contributions shall be calculated and allocated between institutions in accordance with the rules laid down in Articles 69 and 70. The total amount of extraordinary ex-post contributions per year shall not exceed three times the annual amount of contributions determined in accordance with Article 70. 2. The Board shall, on its own initiative after consulting the national resolution authority or upon proposal by a national resolution authority, defer, in whole or in part, in accordance with the delegated acts referred to in paragraph 3, an institution's payment of extraordinary ex-post contributions in accordance with paragraph 1 if it is necessary to protect its financial position. Such a deferral shall not be granted for a period of longer than six months but may be renewed on request of the institution. The contributions deferred pursuant to this paragraph shall be made later at a point in time when the payment no longer jeopardises the institution's financial position. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 93 to specify the circumstances and conditions under which the payment of ex-post contributions by an entity referred to in Article 2 may be partially or entirely deferred pursuant to paragraph 2 of this Article. Article 72 Voluntary borrowing between resolution financing arrangements 1. The Board shall decide to make a request to voluntarily borrow for the Fund from resolution financing arrangements within non-participating Member States, in the event that: (a) the amounts raised under Article 70 are not sufficient to cover the losses, costs or other expenses incurred by the use of the Fund in relation to resolution actions; (b) the extraordinary ex-post contributions provided for in Article 71 are not immediately accessible; and (c) the alternative funding means provided for in Article 73 are not immediately accessible on reasonable terms. 2. Those resolution financing arrangements shall decide on such a request in accordance with Article 106 of Directive 2014/59/EU. The borrowing conditions shall be subject to Article 106(4), (5) and (6) of Directive 2014/59/EU. 3. The Board may decide to lend to other resolution financing arrangements within non-participating Member States if a request is made in accordance with Article 106 of Directive 2014/59/EU. The lending conditions shall be subject to Article 106(4), (5) and (6) of Directive 2014/59/EU. Article 73 Alternative funding means 1. The Board may contract for the Fund borrowings or other forms of support from those institutions, financial institutions or other third parties, which offer better financial terms at the most appropriate time so as to optimise the cost of funding and preserve its reputation in the event that the amounts raised in accordance with Articles 70 and 71 are not immediately accessible or do not cover the expenses incurred by the use of the Fund in relation to resolution actions. 2. The borrowing or other forms of support referred to in paragraph 1 shall be fully recouped in accordance with Articles 69, 70 and 71 within the maturity period of the loan. 3. Any expenses incurred by the use of the borrowings specified in paragraph 1 shall be borne by Part II of the budget of the Board and not by the Union budget or the participating Member States. Article 74 Access to financial facility The Board shall contract for the Fund financial arrangements, including, where possible, public financial arrangements, regarding the immediate availability of additional financial means to be used in accordance with Article 76, where the amounts raised or available in accordance with Articles 70 and 71 are not sufficient to meet the Funds' obligations. Section 2 Administration of the Fund Article 75 Investments 1. The Board shall administer the Fund in accordance with this Regulation and delegated acts adopted under paragraph 4. 2. The amounts received from an institution under resolution or a bridge institution, the interests and other earnings on investments and any other earnings shall benefit only the Fund. 3. The Board shall have a prudent and safe investment strategy that is provided for in the delegated acts adopted pursuant to paragraph 4 of this Article, and shall invest the amounts held in the Fund in obligations of the Member States or intergovernmental organisations, or in highly liquid assets of high creditworthiness, taking into account the delegated act referred to in Article 460 of Regulation (EU) No 575/2013 as well as other relevant provisions of that Regulation. Investments shall be sufficiently sectorally, geographically and proportionally diversified. The return on those investments shall benefit the Fund. 4. The Commission shall be empowered to adopt delegated acts on the detailed rules for the administration of the Fund and general principles and criteria for its investment strategy, in accordance with the procedure laid down in Article 93. Section 3 Use of the Fund Article 76 Mission of the Fund 1. Within the resolution scheme, when applying the resolution tools to entities referred to in Article 2, the Board may use the Fund only to the extent necessary to ensure the effective application of the resolution tools for the following purposes: (a) to guarantee the assets or the liabilities of the institution under resolution, its subsidiaries, a bridge institution or an asset management vehicle; (b) to make loans to the institution under resolution, its subsidiaries, a bridge institution or an asset management vehicle; (c) to purchase assets of the institution under resolution; (d) to make contributions to a bridge institution and an asset management vehicle; (e) to pay compensation to shareholders or creditors if, following an evaluation pursuant to Article 20(5) they have incurred greater losses that they would have incurred, following a valuation pursuant to Article 20(16), in a winding up under normal insolvency proceedings; (f) to make a contribution to the institution under resolution in lieu of the write-down or conversion of liabilities of certain creditors, when the bail-in tool is applied and the decision is made to exclude certain creditors from the scope of bail-in in accordance with Article 27(5); (g) to take any combination of the actions referred to in points (a) to (f). 2. The Fund may be used to take the actions referred to in paragraph 1 also with respect to the purchaser in the context of the sale of business tool. 3. The Fund shall not be used directly to absorb the losses of an entity referred to in Article 2 or to recapitalise such an entity. In the event that the use of the Fund for the purposes in paragraph 1of this Article indirectly results in part of the losses of an entity referred to in Article 2 being passed on to the Fund, the principles governing the use of the Fund set out in Article 27 shall apply. 4. The Board may not hold the capital contributed to in accordance with point (f) of paragraph 1 for a period exceeding five years. Article 77 Use of the Fund The use of the Fund shall be contingent upon the Agreement whereby the participating Member States agree to transfer to the Fund the contributions that they raise at national level in accordance with this Regulation and with Directive 2014/59/EU and shall comply with the principles laid down in that Agreement. Accordingly, until the Fund reaches the target level referred to in Article 69, but until no later than eight years after the date of application of this Article, the Board shall use the Fund in accordance with principles founded on a division of the Fund into national compartments corresponding to each participating Member State, as well as on a progressive merger of the different funds raised at national level to be allocated to national compartments of the Fund, as laid down in the Agreement. Article 78 Mutualisation of national financing arrangements in the case of group resolution involving institutions in non-participating Member States In the case of a group resolution involving institutions established in one or more participating Member States on the one hand, and institutions established in one or more non-participating Member States on the other hand, the Fund shall contribute to the financing of the group resolution in accordance with the provisions laid down in Article 107(2) to (5) of Directive 2014/59/EU. Article 79 Use of deposit guarantee schemes in the context of resolution 1. Participating Member States shall ensure that when the Board takes resolution action, provided that that action ensures that depositors continue to have access to their deposits, the deposit guarantee scheme to which the institution is affiliated shall be liable for the amounts specified in Article 109(1) and (4) of Directive 2014/59/EU. The relevant deposit guarantee scheme shall subrogate to the rights and obligations of covered depositors in liquidation proceedings for an amount equal to its payment. 2. The determination of the amount by which the deposit guarantee scheme is liable in accordance with paragraph 1 of this Article shall comply with the conditions referred to in Article 20. 3. Before deciding, in accordance with paragraph 2 of this Article, the amount by which the deposit guarantee scheme is liable, the Board shall consult the concerned designated authority within the meaning of Article 2(1)(18) of Directive 2014/49/EU, taking fully into account the urgency of the matter. 4. Where eligible deposits at an institution under resolution are transferred to another entity through the sale of business tool or the bridge institution tool, the depositors have no claim under Directive 2014/49/EU against the deposit guarantee scheme in relation to any part of their deposits at the institution under resolution that are not transferred, provided that the amount of funds transferred is equal to or more than the aggregate coverage level provided for in Article 6 of that Directive. 5. Notwithstanding paragraphs 1 to 4, if the available financial means of a deposit guarantee scheme are used in accordance therewith and are subsequently reduced to less than two-thirds of the target level of the deposit guarantee scheme, the regular contribution to the deposit guarantee scheme shall be set at a level allowing for reaching the target level within six years. The liability of a deposit guarantee scheme shall not be greater than the amount equal to 50 % of its target level pursuant to Article 10(2) of Directive 2014/49/EU. In any circumstances, the deposit guarantee scheme's participation under this Regulation shall not exceed the losses it would have incurred in a winding up under normal insolvency proceedings. TITLE VI OTHER PROVISIONS Article 80 Privileges and Immunities Protocol No 7 on the Privileges and Immunities of the European Union annexed to the TEU and to the TFEU shall apply to the Board and its staff. Article 81 Language arrangements 1. Council Regulation No 1 (23) shall apply to the Board. 2. The Board shall decide on the internal language arrangements for the Board. 3. The Board may decide which of the official languages to use when sending documents to Union institutions or bodies. 4. The Board may agree with each national resolution authority on the language or languages in which the documents to be sent to or by the national resolution authorities shall be drafted. 5. The translation services required for the functioning of the Board shall be provided by the Translation Centre of the bodies of the European Union. Article 82 Staff 1. The Staff Regulations, the Conditions of Employment and the rules adopted jointly by the Union institutions, for the purpose of applying them shall apply to the staff of the Board. By way of derogation from the first subparagraph, the Chair, the Vice-Chair and the four members referred to in Article 43(1)(b) shall, respectively, be on a par with a Vice-President, Judge and Registrar of the Court of Justice regarding emoluments and pensionable age, as defined in Regulation (EC) No 422/67/EEC, 5/67/Euratom of the Council (24). They shall not be subject to a maximum retirement age. For aspects not covered by this Regulation or by Regulation (EC) No 422/67/EEC, 5/67/Euratom, the Staff Regulations and the Conditions of Employment shall apply by analogy. 2. The Board, in agreement with the Commission, shall adopt the necessary implementing measures, in accordance with the arrangements provided for in Article 110 of the Staff Regulations. 3. In respect of its staff, the Board shall exercise the powers conferred on the appointing authority by the Staff Regulations and on the authority entitled to conclude contracts by the Conditions of Employment. Article 83 Staff exchange 1. The Board may make use of seconded national experts or other staff not employed by the Board. 2. The Board in its plenary session shall adopt appropriate decisions laying down rules on the exchange and secondment of staff from and among the national resolution authorities to the Board. 3. The Board may establish internal resolution teams composed of its own staff and staff of the national resolution authorities, as well as observers from non-participating Member States' resolution authorities, where appropriate. 4. Where the Board establishes internal resolution teams as provided for in paragraph 3 of this Article, it shall appoint coordinators of those teams from its own staff. In accordance with Article 51(3), the coordinators may be invited as observers to attend the meetings of the executive session of the Board in which the members appointed by the respective Member States participate in accordance with Article 53(3) and (4). Article 84 Internal committees The Board may establish internal committees to provide it with advice and guidance on the discharge of its functions under this Regulation. Article 85 Appeal Panel 1. The Board shall establish an Appeal Panel for the purposes of deciding on appeals submitted in accordance with paragraph 3. 2. The Appeal Panel shall be composed of five individuals of high repute, from the Member States and with a proven record of relevant knowledge and professional experience, including resolution experience, to a sufficiently high level in the fields of banking or other financial services, excluding current staff of the Board, as well as current staff of resolution authorities or other national or Union institutions, bodies, offices and agencies who are involved in performing the tasks conferred on the Board by this Regulation. The Appeal Panel shall have sufficient resources and expertise to provide expert legal advice on the legality of the Board's exercise of its powers. Members of the Appeal Panel and two alternates shall be appointed by the Board for a term of five years, which may be extended once, following a public call for expressions of interest published in the Official Journal of the European Union. They shall not be bound by any instructions. 3. Any natural or legal person, including resolution authorities, may appeal against a decision of the Board referred to in Article 10(10), Article 11, Article 12(1), Articles 38 to 41, Article 65(3), Article 71 and Article 90(3) which is addressed to that person, or which is of direct and individual concern to that person. The appeal, together with a statement of grounds, shall be filed in writing at the Appeal Panel within six weeks of the date of notification of the decision to the person concerned, or, in the absence of a notification, of the day on which the decision came to the knowledge of the person concerned. 4. The Appeal Panel shall decide upon the appeal within one month after the appeal has been lodged. The Appeal Panel shall decide on the basis of a majority of at least three of its five members. 5. The members of the Appeal Panel shall act independently and in the public interest. For that purpose, they shall make a public declaration of commitments and a public declaration of interests indicating any direct or indirect interest which might be considered to be prejudicial to their independence or the absence of any such interest. 6. An appeal lodged pursuant to paragraph 3 shall not have suspensive effect. However, the Appeal Panel may, if it considers that circumstances so require, suspend the application of the contested decision. 7. If the appeal is admissible, the Appeal Panel shall examine whether it is well founded. It shall invite the parties to the appeal proceedings to file observations on its own notifications or on communications from the other parties to the appeal proceedings, within specified time limits. Parties to the appeal proceedings shall be entitled to make oral representations. 8. The Appeal Panel may confirm the decision taken by the Board, or remit the case to the latter. The Board shall be bound by the decision of Appeal Panel and it shall adopt an amended decision regarding the case concerned. 9. The decisions of the Appeal Panel shall be reasoned and notified to the parties. 10. The Appeal Panel shall adopt and make public its rules of procedure. Article 86 Actions before the Court of Justice 1. Proceedings may be brought before the Court of Justice in accordance with Article 263 TFEU contesting a decision taken by the Appeal Panel or, where there is no right of appeal to the Appeal Panel, by the Board. 2. Member States and the Union institutions, as well as any natural or legal person, may institute proceedings before the Court of Justice against decisions of the Board, in accordance with Article 263 TFEU. 3. In the event that the Board has an obligation to act and fails to take a decision, proceedings for failure to act may be brought before the Court of Justice in accordance with Article 265 TFEU. 4. The Board shall take the necessary measures to comply with the judgment of the Court of Justice. Article 87 Liability of the Board 1. The Board's contractual liability shall be governed by the law applicable to the contract in question. 2. The Court of Justice shall have jurisdiction to give judgement pursuant to any arbitration clause contained in a contract concluded by the Board. 3. In the case of non-contractual liability, the Board shall, in accordance with the general principles common to the laws concerning the liability of public authorities of the Member States, make good any damage caused by it or by its staff in the performance of their duties, in particular their resolution functions, including acts and omissions in support of foreign resolution proceedings. 4. The Board shall compensate a national resolution authority for the damages which it has been ordered to pay by a national court, or which it has, in agreement with the Board, undertaken to pay pursuant to an amicable settlement, which are the consequences of an act or omission committed by that national resolution authority in the course of any resolution under this Regulation of entities and groups referred to in Article 7(2), and of entities and groups referred to in Article 7(4)(b) and (5) where the conditions for the application of those paragraphs are met or pursuant to the second subparagraph of Article 7(3). That obligation shall not apply where that act or omission constituted an infringement of this Regulation, of another provision of Union law, of a decision of the Board, of the Council, or of the Commission, committed intentionally or with manifest and serious error of judgement. 5. The Court of Justice shall have jurisdiction in any dispute relating to paragraphs 3 and 4. Proceedings in matters arising from non-contractual liability shall be barred after a period of five years from the occurrence of the event giving rise thereto. 6. The personal liability of its staff towards the Board shall be governed by the provisions laid down in the Staff Regulations or Conditions of Employment applicable to them. Article 88 Professional secrecy and exchange of information 1. Members of the Board, the Vice-Chair, the members of the Board referred to in Article 43(1)(b), the staff of the Board and staff exchanged with or seconded by participating Member States carrying out resolution duties shall be subject to the requirements of professional secrecy pursuant to Article 339 TFEU and the relevant provisions in Union legislation, even after their duties have ceased. They shall in particular be prohibited from disclosing confidential information received during the course of their professional activities or from a competent authority or resolution authority in connection with their functions under this Regulation, to any person or authority, unless it is in the exercise of their functions under this Regulation or in summary or collective form such that entities referred to in Article 2 cannot be identified or with the express and prior consent of the authority or the entity which provided the information. Information subject to the requirements of professional secrecy shall not be disclosed to another public or private entity except where such disclosure is due for the purpose of legal proceedings. Those requirements shall also apply to potential purchasers contacted in order to prepare for the resolution of an entity pursuant to Article 13(3). 2. The Board shall ensure that individuals who provide any service, directly or indirectly, permanently or occasionally, relating to the discharge of its duties, including officials and other persons authorised by the Board or appointed by the national resolution authorities to conduct on-site inspections, are subject to the requirements of professional secrecy equivalent to those referred to in paragraph 1. 3. The requirements of professional secrecy referred to in paragraph 1 shall also apply to observers who attend the Board's meetings and to observers from non-participating Member States who take part in internal resolution teams in accordance with Article 83(3). 4. The Board shall take the necessary measures to ensure the safe handling and processing of confidential information. 5. Before any information is disclosed, the Board shall ensure that it does not contain confidential information, in particular, by assessing the effects that the disclosure could have on the public interest as regards financial, monetary or economic policy, on the commercial interests of natural and legal persons, on the purpose of inspections, on investigations and on audits. The procedure for checking the effects of disclosing information shall include a specific assessment of the effects of any disclosure of the contents and details of resolution plans as referred to in Articles 8 and 9, the result of any assessment carried out under Article 10 or the resolution scheme referred to in Article 18. 6. This Article shall not prevent the Board, the Council, the Commission, the ECB, the national resolution authorities or the national competent authorities, including their employees and experts, from sharing information with each other and with competent ministries, central banks, deposit guarantee schemes, investor compensation schemes, authorities responsible for normal insolvency proceedings, resolution and competent authorities from non-participating Member States, EBA, or, subject to Article 33, third-country authorities that carry out functions equivalent to those of a resolution authority, or, subject to strict confidentiality requirements, with a potential purchaser for the purposes of planning or carrying out a resolution action. Article 89 Data protection This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Directive 95/46/EC of the European Parliament and of the Council (25) or the obligations of the Board, the Council and the Commission relating to their processing of personal data under Regulation (EC) No 45/2001 of the European Parliament and of the Council (26) when fulfilling their responsibilities. Article 90 Access to documents 1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council (27) shall apply to documents held by the Board. 2. The Board shall, within six months of the date of its first meeting, adopt the practical measures for applying Regulation (EC) No 1049/2001. 3. Decisions taken by the Board under Article 8 of Regulation (EC) No 1049/2001 may be the subject of a complaint to the European Ombudsman or of proceedings before the Court of Justice, following an appeal to the Appeal Panel, referred to in Article 85 of this Regulation, as appropriate, under the conditions laid down in Articles 228 and 263 TFEU respectively. 4. Persons who are the subject of the Board's decisions shall be entitled to have access to the Board's file, subject to the legitimate interest of other persons in the protection of their business secrets. The right of access to the file shall not extend to confidential information or internal preparatory documents of the Board. Article 91 Security rules on the protection of classified and sensitive non-classified information The Board shall apply the security principles contained in the Commission's security rules for protecting European Union Classified Information (EUCI) and sensitive non-classified information, as set out in the Annex to Commission Decision 2001/844/EC, ECSC, Euratom (28). Applying the security principles shall include applying provisions for the exchange, processing and storage of such information. Article 92 Court of Auditors 1. The Court of Auditors shall produce a special report for each 12-month period, starting on 1 April each year. 2. Each report shall examine whether: (a) sufficient regard was had to economy, efficiency and effectiveness with which the Fund has been used, in particular the need to minimise the use of the Fund; (b) the assessment of Fund aid was efficient and rigorous. 3. Each report under paragraph 1 shall be produced within six months of the end of the period to which the report relates. 4. Following consideration of the final accounts prepared by the Board in accordance with Article 63, the Court of Auditors shall prepare a report on its findings by 1 December following each financial year. The Court of Auditors shall, in particular, report on any contingent liabilities (whether for the Board, the Council, the Commission or otherwise) arising as a result of the performance by the Board, the Council and the Commission of their tasks under this Regulation. 5. The European Parliament and the Council may request that the Court of Auditors examine any other relevant matters falling within their competence set out in Article 287(4) TFEU. 6. The reports referred to in paragraphs 1 and 4 shall be sent to the Board, the European Parliament, the Council and the Commission and shall be made public without delay. 7. Within two months of the date on which each report under paragraph 1 is made public the Commission shall provide a detailed written response which shall be made public. Within two months of the date on which each report under paragraph 4 is made public the Board, the Council and the Commission shall each provide a detailed written response which shall be made public. 8. The Court of Auditors shall have the power to obtain from the Board, the Council and the Commission any information relevant for performing the tasks conferred on it by this Article. The Board, the Council and the Commission shall provide any relevant information requested within such a timeframe as may be specified by the Court of Auditors. PART IV POWERS OF EXECUTION AND FINAL PROVISIONS Article 93 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Article 19(8), Article 65(5), Article 69(5), Article 71(3) and Article 75(4) shall be conferred for an indeterminate period of time from the relevant dates referred to in Article 99. 3. The Commission shall ensure consistency between delegated acts adopted pursuant to this Regulation and delegated acts adopted pursuant to Directive 2014/59/EU. 4. The delegation of power referred to in Article 19(8), Article 65(5), Article 69(5), Article 71(3) and Article 75(4) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 19(8), Article 65(5), Article 69(5), Article 71(3) and Article 75(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or the Council. 7. The Commission shall not adopt delegated acts where the scrutiny time of the European Parliament is reduced through recess to less than five months, including any extension. Article 94 Review 1. By 31 December 2018, and every three years thereafter, the Commission shall publish a report on the application of this Regulation, with a special emphasis on monitoring the potential impact on the smooth functioning of the internal market. That report shall evaluate: (a) the functioning of the SRM, its cost efficiency, as well as the impact of its resolution activities on the interests of the Union as a whole and on the coherence and integrity of the internal market for financial services, including its possible impact on the structures of the national banking systems within the Union, in comparison with other banking systems, and regarding the effectiveness of cooperation and information sharing arrangements within the SRM, between the SRM and the SSM, and between the SRM, national resolution authorities, competent authorities and resolution authorities of non-participating Member States, in particular assessing whether: (i) there is a need that the functions allocated by this Regulation to the Board, to the Council and to the Commission, be exercised exclusively by an independent Union institution and, if so, whether any changes of the relevant provisions are necessary including at the level of primary law; (ii) cooperation between the SRM, the SSM, the ESRB, EBA, ESMA and EIOPA, and the other authorities which form part of the ESFS, is appropriate; (iii) the investment portfolio in accordance with Article 75 is made of sound and diversified assets; (iv) the link between sovereign debt and banking risk has been broken; (v) governance arrangements, including the division of tasks within the Board and the composition of the voting arrangements both in the executive and the plenary sessions of the Board and its relations with the Commission and the Council are appropriate; (vi) the reference point for setting the target level for the Fund is adequate and in particular, whether covered deposits or total liabilities is a more appropriate basis and if a minimum absolute amount for the Fund should be established in order to avoid volatility in the flow of financial means to the Fund and to ensure the stability and adequacy of the financing of the Fund over time; (vii) it is necessary to modify the target level established for the Fund and the level of contributions in order to ensure a level playing field within the Union; (b) the effectiveness of independence and accountability arrangements; (c) the interaction between the Board and EBA; (d) the interaction between the Board and the national resolution authorities of non-participating Member States and the effects of the SRM on those Member States, and the interaction between the Board and relevant third-country authorities as defined in Article 2(1)(90) of Directive 2014/59/EU; (e) the necessity of taking steps in order to harmonise insolvency proceedings for failed institutions. 2. The report shall be submitted to the European Parliament and to the Council. The Commission shall make accompanying proposals, as appropriate. 3. When reviewing Directive 2014/59/EU, the Commission is invited also to review this Regulation, as appropriate. Article 95 Amendment to Regulation (EU) No 1093/2010 Regulation (EU) No 1093/2010 is amended as follows: (1) In Article 4, point (2) is replaced by the following: ‘(2) “competent authorities” means: (i) competent authorities as defined in point (40) of Article 4(1) of Regulation (EU) No 575/2013, including the European Central Bank with regard to matters relating to the tasks conferred on it by Regulation (EU) No 1024/2013, in Directive 2007/64/EC, and as referred to in Directive 2009/110/EC; (ii) with regard to Directives 2002/65/EC and 2005/60/EC, the authorities competent for ensuring compliance with the requirements of those Directives by credit and financial institutions; (iii) with regard to deposit guarantee schemes, bodies which administer deposit guarantee schemes pursuant to Directive 2014/49/EU of the European Parliament and of the Council (29), or, where the operation of the deposit guarantee scheme is administered by a private company, the public authority supervising those schemes pursuant to that Directive; and (iv) with regard to Directive 2014/59/EU of the European Parliament and of the Council (30) and to Regulation (EU) No 806/2014 of the European Parliament and of the Council (31), the resolution authorities, defined in Article 3 of Directive 2014/59/EU, the Single Resolution Board, established by Regulation (EU) No 806/2014, and the Council and the Commission when taking actions under Article 18 of Regulation (EU) No 806/2014, except where they exercise discretionary powers or make policy choices. (29) Directive 2014/49/EU of the European Parliament and of the Council of 16 April 2014 on deposit guarantee scheme (OJ L 173, 12.6.2014, p. 149)." (30) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190)." (31) Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (OJ L 225, 30.7.2014, p. 1).’;" (2) In Article 25, the following paragraph is inserted: ‘1a. The Authority may organise and conduct peer reviews of the exchange of information and of the joint activities of the Board referred to in Regulation (EU) No 806/2014 and national resolution authorities of Member States non-participating in the Single Resolution Mechanism in the resolution of cross-border groups to strengthen effectiveness and consistency in outcomes. To that end, the Authority shall develop methods to allow for objective assessment and comparison.’; (3) In Article 40(6), the following subparagraph is added: ‘For the purpose of acting within the scope of Directive 2014/59/EU, the Chair of the Single Resolution Board shall be an observer to the Board of Supervisors.’. Article 96 Replacement of national resolution financing arrangements From the date of application referred to in Article 99(2) and (6) of this Regulation, the Fund shall be considered to be the resolution financing arrangement of the participating Member States under Articles 99 to 109 of Directive 2014/59/EU. Article 97 Headquarters Agreement and operating conditions 1. The necessary arrangements concerning the accommodation to be provided for the Board in the Member State where its seat is located and the facilities to be made available by that Member State, as well as the specific rules applicable in that Member State to the Chair, members of the Board in its plenary session, Board staff and members of their families shall be laid down in a Headquarters Agreement between the Board and that Member State, concluded after obtaining the approval of the Board in its plenary session and no later than 20 August 2016. 2. The Member State where the Board's seat is located shall provide the best possible conditions to ensure the proper functioning of the Board, including multilingual, European-oriented schooling and appropriate transport connections. Article 98 Start of the Board's activities 1. The Board shall become fully operational by 1 January 2015. 2. The Commission shall be responsible for the establishment and initial operation of the Board until the Board has the operational capacity to implement its own budget. For that purpose: (a) until the Chair takes up his or her duties following his or her appointment by the Council in accordance with Article 56, the Commission may designate a Commission official to act as interim Chair and exercise the duties assigned to the Chair; (b) by way of derogation from Article 50(1)(l) and until the adoption of a decision as referred to in Article 50(3), the interim Chair shall exercise the appointing authority powers; (c) the Commission may offer assistance to the Board, in particular by seconding Commission officials to carry out the activities of the agency under the responsibility of the interim Chair or the Chair. 3. The interim Chair may authorise all payments covered by appropriations entered in the Board's budget and may conclude contracts, including staff contracts. Article 99 Entry into force 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. With the exceptions set out in paragraphs 3 to 5, this Regulation shall be applicable from 1 January 2016. 3. By way of derogation from paragraph 2 of this Article, the provisions relating to the powers of the Board to collect information and cooperate with the national resolution authorities for the elaboration of resolution planning, under Articles 8 and 9 and all of the other related provisions shall apply from 1 January 2015. 4. By way of derogation from paragraph 2 of this Article, Articles 1 to 4, 6, 30, 42 to 48, 49, Article 50(1)(a), (b) and (g) to (p), Article 50(3), Article 51, Article 52(1) and (4), Article 53(1) and (2), Articles 56 to 59, 61 to 66, 80 to 84, 87 to 95 and 97 and 98 shall apply from 19 August 2014. 5. By way of derogation from paragraph 2 of this Article, Article 69(5), Article 70(6) and (7) and Article 71(3), which empower the Council to adopt implementing acts and the Commission to adopt delegated acts, shall apply from 1 November 2014. 6. From 1 January 2015, the Board shall submit a monthly report approved in its plenary session to the European Parliament, to the Council and to the Commission on whether the conditions for the transfer of contributions to the Fund have been met. From 1 December 2015, where those reports show that the conditions for the transfer of contributions to the Fund have not been met, the application of the provisions referred to in paragraph 2 shall be postponed by one month each time. The Board shall submit a further report each time at the end of that month. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 15 July 2014. For the European Parliament The President M. SCHULZ For the Council The President S. GOZI (1) OJ C 109, 11.4.2014, p. 2. (2) OJ C 67, 6.3.2014, p. 58. (3) Position of the European Parliament of 15 April 2014 (not yet published in the Official Journal) and decision of the Council of 14 July 2014. (4) Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (OJ L 287, 29.10.2013, p. 63). (5) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190). (6) Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12). (7) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). (8) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338). (9) Regulation (EU) No 1092/2010 of the European Parliament and of the Council of 24 November 2010 on European Union macro-prudential oversight of the financial system and establishing a European Systemic Risk Board (OJ L 331, 15.12.2010, p. 1). (10) Directive 2014/49/EU of the European Parliament and of the Council of 16 April 2014 on deposit guarantee schemes (OJ L 173, 12.6.2014, p. 149). (11) Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Investment and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC (OJ L 331, 15.12.2010, p. 48). (12) Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84). (13) Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 302, 17.11.2009, p. 32). (14) Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor-compensation schemes (OJ L 84, 26.3.1997, p. 22). (15) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349). (16) Council Directive 2001/23/EC of 12 March 2001 on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses (OJ L 82, 22.3.2001, p. 16). (17) Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ L 174, 1.7.2011, p. 1). (18) Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems (OJ L 166, 11.6.1998, p. 45). (19) Regulation (EEC, Euratom, ECSC) No 259/68 of the Council of 29 February 1968 laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Communities and instituting special measures temporarily applicable to officials of the Commission (OJ L 56, 4.3.1968, p. 1). (20) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (21) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (22) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (23) Council Regulation No 1 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385). (24) Regulation (EC) No 422/67/EEC, No 5/67/Euratom of the Council of 25 July 1967 determining the emoluments of the President and Members of the Commission, of the President, Judges, Advocates-General and Registrar of the Court of Justice, of the President, Members and Registrar of the General Court and of the President, Members and Registrar of the European Union Civil Service Tribunal (OJ L 187, 8.8.1967, p. 1). (25) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (26) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (27) Regulation (EC) N0 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (28) Commission Decision 2001/844/EC, ECSC, Euratom of 29 November 2001 amending its internal Rules of Procedure (OJ L 317, 3.12.2001, p. 1).

Failing banks and investment firms: rules and procedures Failing banks and investment firms: rules and procedures SUMMARY OF: Regulation (EU) No 806/2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund Regulation (EU) 2019/877 amending Regulation (EU) No 806/2014 as regards the loss-absorbing and recapitalisation capacity of credit institutions and investment firms WHAT IS THE AIM OF THE REGULATION? Regulation (EU) No 806/2014 sets out the structure of the Single Resolution Board (SRB). It is made up of a chair, a vice-chair, 4 permanent members and the authorities from all participating EU countries. It operates in: executive sessions: the chair, 4 further independent full-time members, 2 permanent observers appointed by the European Commission and by the European Central Bank (ECB) and, in specific cases, representatives of national resolution authorities of participating countries or other observers; andplenary sessions: the full board, as above, and representatives of all national resolution authorities of participating countries. It introduces uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms through a single resolution mechanism and the use of a single resolution fund. While the regulation applies to euro area countries, other EU countries are also allowed to participate. Regulation (EU) 2019/877 amends the original regulation to incorporate in EU legislation international standards on loss-absorption and recapitalisation for banks set by the Financial Stability Board. KEY POINTS The Single Resolution Board When a bank is deemed to be in a crisis situation, the board may put together a resolution scheme that is passed on to the Commission for formal approval. If the Commission has no objections, the scheme should be adopted within 24 hours. In some specific cases, the Commission can request the Council to approve its amendments to the scheme. A resolution scheme of less than €5 billion from the single resolution fund is decided in executive session board meetings, which only include the national resolution authority from the EU country where the bank in crisis is located. When more than €5 billion is needed, decisions are taken by the plenary session. The single resolution fund Funded by banks from 2016 onwards, the single resolution fund should amount to 1% of insured deposits in all participating EU countries (for a total of around €55 billion) in 2024. Along with Regulation (EU) No 806/2014, an intergovernmental agreement was signed between participating EU countries. This allows for: the transfer of banks’ contributions to national compartments of the fund; andthe progressive mutualisation* of those contributions in the fund. Single resolution mechanism Together, the SRB and the single resolution fund make up the single resolution mechanism. This system and the single supervisory mechanism, that gives supervisory powers to the ECB, are the foundations of the EU’s banking union, which applies to euro area countries. Other EU countries may also participate. Banks covered The SRB is responsible for the resolution of all banks that are supervised by the ECB. As in the case of the single supervisory mechanism, the SRB is directly responsible for the largest banks that are directly supervised by the ECB and for other cross-border banks. Other banks remain under the direct responsibility of their national resolution authorities. However, they remain under the indirect responsibility of the SRB, and the SRB may step in if their resolution scheme requires the use of the single resolution fund. Calculation of individual institutions’ contributions Regulation (EU) 2015/81 lays down rules relating to the obligation of the SRB to calculate the contributions for individual institutions and the methodology for their calculation. Loss-absorbing and recapitalisation capacity of credit institutions and investment firms In incorporating international standards on loss absorption and recapitalisation into EU law for global systemically important banks and amending the existing rules for other banks, Regulation (EU) 2019/877 provides for the rules for banks to deal with losses by ensuring that they hold enough capital and other liabilities to minimise as much as possible any taxpayer bail-outs. WHEN DOES THE REGULATION APPLY? Regulation (EU) No 806/2014 has applied since 1 January 2016. However, some rules, such as the start of the board’s activities, have applied since 1 January 2015. Regulation (EU) 2019/877 applies from 28 December 2020. BACKGROUND For more information, see: Single resolution mechanism (European Commission) Single supervisory mechanism (European Commission) Communication from the Commission Temporary Framework for State aid measures to support the economy in the current COVID-19 outbreak (European Commission). KEY TERMS Mutualisation: the process by which the costs of restructuring are shared by the participating banks. MAIN DOCUMENTS Regulation (EU) No 806/2014 of the European Parliament and of the Council of 15 July 2014 establishing uniform rules and a uniform procedure for the resolution of credit institutions and certain investment firms in the framework of a Single Resolution Mechanism and a Single Resolution Fund and amending Regulation (EU) No 1093/2010 (OJ L 225, 30.7.2014, pp. 1-90) Regulation (EU) 2019/877 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EU) No 806/2014 as regards the loss-absorbing and recapitalisation capacity of credit institutions and investment firms (OJ L 150, 7.6.2019, pp. 226-252) RELATED DOCUMENTS Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (OJ L 287, 29.10.2013, pp. 63-89) Regulation (EU) No 1022/2013 of the European Parliament and of the Council of 22 October 2013 amending Regulation (EU) No 1093/2010 establishing a European Supervisory Authority (European Banking Authority) as regards the conferral of specific tasks on the European Central Bank pursuant to Council Regulation (EU) No 1024/2013 (OJ L 287, 29.10.2013, pp. 5-14) Council Implementing Regulation (EU) 2015/81 of 19 December 2014 specifying uniform conditions of application of Regulation (EU) No 806/2014 of the European Parliament and of the Council with regard to ex ante contributions to the Single Resolution Fund (OJ L 15, 22.1.2015, pp. 1-7) last update 17.12.2019

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1.4.2020 EN Official Journal of the European Union L 101/4 COUNCIL DECISION (CFSP) 2020/472 of 31 March 2020 on a European Union military operation in the Mediterranean (EUNAVFOR MED IRINI) THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on European Union, and in particular Articles 42(4) and 43(2) thereof, Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy, Whereas: (1) On 19 January 2020, a Conference was held in Berlin on Libya. Participants committed in particular to unequivocally and fully respecting and implementing the arms embargo established by the United Nations Security Council Resolution (UNSCR) 1970 (2011) and subsequent Resolutions, in particular UNSCRs 2292 (2016) and 2473 (2019). (2) On 12 February 2020, in UNSCR 2510 (2020), the United Nations (UN) Security Council welcomed the Berlin Conference on Libya and endorsed its conclusions, noting that those conclusions represent an important element of a comprehensive solution to the situation in Libya. It also demanded full compliance by all UN Member States with the arms embargo, and further demanded all States not to intervene in the conflict or take measures that exacerbate the conflict. (3) On 11 February 2020, in UNSCR 2509 (2020), the UN Security Council extended the measures imposed by UNSCR 2146 (2014) to prevent the illicit export from Libya of petroleum, including crude oil and refined petroleum products, and extended the mandate of the Panel of Experts established by UNSCR 1973 (2011). (4) On 17 February 2020, the Council reached a political agreement to launch a new operation in the Mediterranean, aimed at implementing the UN arms embargo on Libya by using aerial, satellite and maritime assets. The operation should, as secondary tasks, contribute to the implementation of UN measures to prevent the illicit export of petroleum from Libya, to capacity building and training of the Libyan Coast Guard and Navy, and to the disruption of the business model of human smuggling and trafficking networks. The Area of Operation and the Area of Interest of the operation should be defined in accordance with the agreed mandate in the relevant planning documents. (5) In addition, the Council could decide in future to extend the scope of the operation in order to allow for the use of aerial surveillance within Libyan airspace, in accordance with any applicable UNSCR or with the consent of the Libyan authorities, if it assesses that the necessary legal requirements and political conditions are met. (6) On 18 May 2015, the Council adopted Decision (CFSP) 2015/778 (1). EUNAVFOR MED operation SOPHIA has been ongoing since that date, and was extended through Council Decision (CFSP) 2019/1595 (2). (7) The Political and Security Committee (PSC) should exercise, under the responsibility of the Council and the High Representative of the Union for Foreign Affairs and Security Policy (HR), political control over the operation, provide it with strategic direction and take the relevant decisions in accordance with the third paragraph of Article 38 of the Treaty on European Union (TEU). (8) The authorisation of the operation should be reconfirmed every four months and the PSC, in exercising its political control and strategic direction of the operation, should be authorised to take such a decision prolonging the operation unless the deployment of maritime assets of the operation produces a pull effect on migration on the basis of substantiated evidence gathered according to the criteria set in the Operations Plan. (9) Pursuant to Article 41(2) TEU and in accordance with Council Decision (CFSP) 2015/528 (3), the operational expenditure arising from this Decision, which has military or defence implications, is to be borne by the Member States. (10) In accordance with Article 5 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the Treaty on the Functioning of the European Union (TFEU), Denmark does not participate in the elaboration and implementation of decisions and actions of the Union which have defence implications. Consequently, Denmark is not participating in the adoption of this Decision, is neither bound by it nor subject to its application, and does not participate in the financing of this operation, HAS ADOPTED THIS DECISION: Article 1 Mission 1. The Union hereby establishes and launches a military crisis management operation to contribute to preventing arms trafficking within its agreed Area of Operation and Area of Interest in accordance with UNSCR 1970 (2011) and subsequent Resolutions on the arms embargo on Libya, including UNSCR 2292 (2016) and UNSCR 2473 (2019). Furthermore, the operation shall contribute to the implementation of UN measures to prevent the illicit export of petroleum from Libya in accordance with UNSCR 2146 (2014) and subsequent Resolutions, in particular UNSCR 2509 (2020) and UNSCR 2510 (2020). In addition, the operation shall assist in the development of the capacities and in the training of the Libyan Coast Guard and Navy in law enforcement tasks at sea. The operation shall also contribute to the disruption of the business model of human smuggling and trafficking networks, in accordance with applicable international law, including the UN Convention on the Law of the Sea, any relevant UNSCR, and international human rights law as applicable. 2. The operation shall be named EUNAVFOR MED IRINI. 3. The Area of Operation, the Area of Interest and the detailed arrangements for gathering information in those areas in order to fulfil all the tasks of the operation shall be defined in the relevant planning documents approved by the Council. Article 2 Contributing to implementation of the UN arms embargo on Libya 1. EUNAVFOR MED IRINI shall, as its core task, contribute to the implementation of the UN arms embargo on Libya with aerial, satellite and maritime assets. 2. For that purpose, EUNAVFOR MED IRINI shall gather extensive and comprehensive information on the trafficking of arms and related materiel from all directions and share it with relevant partners and agencies on a case-by-case and need-to-know basis through the mechanisms in the relevant planning documents in order to contribute to a full situational awareness in the Area of Operation and in the Area of Interest. Where such information is classified up to ‘SECRET UE/EU SECRET’ level, it may be exchanged with relevant partners and agencies in accordance with Council Decision 2013/488/EU (4) and based on arrangements concluded at the operational level in accordance with Article 14(9) of this Decision, and in full respect of the principles of reciprocity and inclusiveness. Classified information received shall be handled by EUNAVFOR MED IRINI without any distinction between its staff and solely on the basis of operational requirements. 3. In accordance with the relevant UNSCRs, in particular UNSCR 2292 (2016), and as required, EUNAVFOR MED IRINI shall carry out, in accordance with the arrangements set out in the planning documents, and within the agreed Area of Operation on the high seas off the coast of Libya, inspections of vessels bound to or from Libya where there are reasonable grounds to believe that such vessels are carrying arms or related materiel to or from Libya, directly or indirectly, in violation of the arms embargo on Libya. EUNAVFOR MED IRINI shall take relevant action to seize and dispose of such items, including with a view to diverting such vessels and their crews to a suitable port to facilitate such disposal, with the consent of the port State, in accordance with relevant UNSCRs including UNSCR 2292 (2016). 4. EUNAVFOR MED IRINI shall report to the PSC on all issues and events related to such inspections. The PSC may consider any subsequent measures, as appropriate. 5. In view of the exceptional operational requirements, and upon invitation from a Member State, EUNAVFOR MED IRINI may divert vessels to ports of that Member State and dispose within that Member State of arms and related materiel seized in accordance with paragraph 3, including by storage and destruction. The ports to which vessels may be diverted shall be designated in the Operations Plan. 6. In accordance with relevant UNSCRs, including UNSCR 2292 (2016), EUNAVFOR MED IRINI may, in particular in the course of inspections carried out in accordance with paragraph 3, collect and store evidence related to the carriage of items prohibited under the arms embargo on Libya. EUNAVFOR MED IRINI may collect and store, in accordance with applicable law, personal data concerning persons involved in the carriage of such prohibited items related to characteristics likely to assist in their identification, including fingerprints, as well as the following particulars, with the exclusion of other personal data: surname, maiden name, given names and any alias or assumed name; date and place of birth, nationality, sex, place of residence, profession and whereabouts; driving licenses, identification documents and passport data. EUNAVFOR MED IRINI may transmit such data as well as data related to the vessels and equipment used by such persons, and the relevant information acquired while carrying out this core task, to the relevant law enforcement authorities of Member States and to competent Union bodies in accordance with applicable law. Article 3 Contributing to implementation of the UN measures against illicit exports of petroleum from Libya 1. As a secondary task, and within its means and capabilities, EUNAVFOR MED IRINI shall conduct monitoring and surveillance activities and gather information on illicit exports from Libya of petroleum, including crude oil and refined petroleum products, which are contrary to UNSCR 2146 (2014) and subsequent UNSCRs, in particular UNSCR 2509 (2020), thereby contributing to situational awareness in the Area of Operation and in the Area of Interest. 2. The information gathered in this context may be stored and released to the legitimate Libyan authorities and to the relevant law enforcement authorities of Member States and to competent Union bodies. Article 4 Capacity building and training of Libyan Coast Guard and Navy 1. As a further secondary task, EUNAVFOR MED IRINI shall assist in the development of the capacities and in the training of the Libyan Coast Guard and Navy in law enforcement tasks at sea, in particular to prevent human smuggling and trafficking. 2. The task referred to in paragraph 1 shall be carried out on the high seas in EUNAVFOR MED IRINI’s agreed Area of Operation. It may also be carried out in the territory, including the territorial waters, of Libya or of a host third State neighbouring Libya where the PSC so decides following an assessment by the Council on the basis of an invitation by Libya or the host State concerned, and in accordance with international law. 3. In view of the exceptional operational requirements, part of the task referred to in paragraph 1 may be conducted in a Member State, upon invitation by that Member State, including in relevant training centres. 4. For the purpose of the task referred to in paragraph 1, EUNAVFOR MED IRINI shall establish and operate a monitoring mechanism in close coordination with other relevant stakeholders, including where necessary in Libya. 5. Insofar as required by the task referred to in paragraph 1, EUNAVFOR MED IRINI may collect, store and exchange with the relevant authorities of Member States, competent Union bodies, the UN Support Mission in Libya, INTERPOL, the International Criminal Court and the United States of America the information, including personal data, gathered for the purpose of the vetting procedures on possible trainees, provided that they have given their consent in writing. Moreover, EUNAVFOR MED IRINI may collect and store necessary medical information and biometric data on trainees provided that they have given their consent in writing. Article 5 Contributing to disruption of the business model of human smuggling and trafficking networks 1. As another secondary task, and in accordance with UNSCR 2240 (2015), EUNAVFOR MED IRINI shall support the detection and monitoring of human smuggling and trafficking networks through information gathering and patrolling carried out by aerial assets above the high seas, in the agreed Area of Operation. 2. In carrying out this task, EUNAVFOR MED IRINI may collect and store, in accordance with applicable law, data on human smuggling and trafficking, including crimes relevant to the security of the operation, which it may transmit to the relevant law enforcement authorities of Member States and to competent Union bodies. Article 6 Appointment of the EU Operation Commander Rear Admiral Fabio AGOSTINI is hereby appointed EU Operation Commander of EUNAVFOR MED IRINI. Article 7 Designation of the EU Operation Headquarters The Operation Headquarters of EUNAVFOR MED IRINI shall be located in Rome, Italy. Article 8 Political control and strategic direction 1. Under the responsibility of the Council and of the HR, the PSC shall exercise the political control and strategic direction of EUNAVFOR MED IRINI. 2. The Council hereby authorises the PSC to take the relevant decisions in accordance with Article 38 TEU. This authorisation shall include the powers to amend the planning documents, including the Operations Plan, the Chain of Command and the Rules of Engagement. It shall also include the powers to take decisions on the appointment of the EU Operation Commander and the EU Force Commander. The powers of decision with respect to the objectives and termination of the EU military operation shall remain vested in the Council. 3. Notwithstanding the period set out in Article 15(2), the authorisation of the operation shall be reconfirmed every four months. The PSC shall prolong the operation unless the deployment of maritime assets of the operation produces a pull effect on migration on the basis of substantiated evidence gathered according to the criteria set in the Operations Plan. 4. The Operation Commander shall report regularly on the conduct of the operation, including its impact in the Area of Operation. In accordance with Article 38 TEU, the PSC may at any time, upon a request from the HR or a Member State, give direction to the Operation Commander on the deployment of assets. 5. The PSC shall report to the Council at regular intervals. 6. The Chairman of the EU Military Committee (EUMC) shall, at regular intervals, report to the PSC on the conduct of EUNAVFOR MED IRINI. The PSC may invite the EU Operation Commander or the EU Force Commander to its meetings, as appropriate. Article 9 Military direction 1. The EUMC shall monitor the proper execution of EUNAVFOR MED IRINI conducted under the responsibility of the EU Operation Commander. 2. The EU Operation Commander shall, at regular intervals, report to the EUMC. The EUMC may invite the EU Operation Commander or the EU Force Commander to its meetings, as appropriate. 3. The Chairman of the EUMC shall act as the primary point of contact with the EU Operation Commander. Article 10 Consistency of the Union’s response and coordination 1. The HR shall ensure the implementation of this Decision and its consistency with the Union’s external action as a whole, including the Union’s development programmes and its humanitarian assistance. 2. The HR, assisted by the European External Action Service (EEAS), shall act as the primary point of contact with the UN, the authorities of the countries in the region, and other international and bilateral actors, including NATO, the African Union and the League of Arab States. 3. EUNAVFOR MED IRINI shall cooperate with the relevant Member State authorities and shall establish a coordination mechanism, and, as appropriate, conclude arrangements with other Union agencies and bodies, in particular Frontex, EUROPOL, EUROJUST, the European Asylum Support Office, the European Union Satellite Centre (SATCEN) and relevant CSDP missions. 4. EUNAVFOR MED IRINI shall host a Crime Information Cell (CIC) composed of staff of relevant law enforcement authorities of Member States and of Union agencies referred to in paragraph 3, in order to facilitate the receipt, collection and transmission of information, including personal data, on the arms embargo on Libya as referred to in Article 2, on illegal exports from Libya of petroleum as referred to in Article 3, and on human smuggling and trafficking as referred to in Article 5, as well as crimes relevant to the security of the operation. 5. The processing of personal data in this context shall be carried out in accordance with the law of the flag State of the vessel on which the CIC is located and, with respect to staff of Union agencies, in accordance with the legal framework applicable to the respective agencies. 6. EUNAVFOR MED IRINI shall be supported by SATCEN and the European Union Intelligence and Situation Centre (INTCEN) in gathering information as necessary to fulfil its tasks. Article 11 Participation by third States 1. Without prejudice to the Union’s decision-making autonomy or to the single institutional framework, and in accordance with the relevant guidelines of the European Council, third States may be invited to participate in the operation. 2. The Council hereby authorises the PSC to invite third States to offer contributions and to take the relevant decisions on acceptance of the proposed contributions, upon the recommendation of the EU Operations Commander and the EUMC. 3. Detailed arrangements for the participation by third States shall be the subject of agreements concluded pursuant to Article 37 TEU and in accordance with the procedure laid down in Article 218 TFEU. Where the Union and a third State have concluded an agreement establishing a framework for the latter’s participation in crisis management missions of the Union, the provisions of such an agreement shall apply in the context of EUNAVFOR MED IRINI. 4. Third States making significant military contributions to EUNAVFOR MED IRINI shall have the same rights and obligations in terms of day-to-day management of the operation as Member States taking part in the operation. 5. The Council hereby authorises the PSC to take relevant decisions on the setting-up of a Committee of Contributors, should third States provide significant military contributions. Article 12 Status of Union-led personnel The status of Union-led units and personnel shall be defined where necessary in accordance with international law. Article 13 Financial arrangements 1. The common costs of the EU military operation shall be administered in accordance with Decision (CFSP) 2015/528. 2. For the period until 31 March 2021, the reference amount for the common costs of EUNAVFOR MED IRINI shall be EUR 9 837 800. The percentage of the reference amount referred to in Article 25(1) of Decision (CFSP) 2015/528 shall be 30 % in commitments and 30 % for payments. Article 14 Release of Information 1. The HR shall be authorised to release to designated third States and the International Criminal Court, as appropriate and in accordance with the operational needs of EUNAVFOR MED IRINI and in full respect of the principles of reciprocity and inclusiveness, any EU non-classified documents connected with the deliberations of the Council relating to the operation and covered by the obligation of professional secrecy pursuant to Article 6(1) of the Council’s Rules of Procedure (5). The PSC, provided that these conditions are met, shall designate on a case-by-case basis the third States concerned. 2. The HR shall be authorised to release to designated third States and the International Criminal Court, as appropriate and in accordance with the operational needs of EUNAVFOR MED IRINI, and in full respect of the principles of reciprocity and inclusiveness, EU classified information generated for the purposes of the operation, in accordance with Decision 2013/488/EU, as follows: (a) up to the level provided in the applicable Security of Information Agreements concluded between the Union and the third State concerned; or (b) up to the ‘CONFIDENTIEL UE/EU CONFIDENTIAL’ level in other cases. The PSC, provided that these conditions are met, shall designate on a case-by-case basis the third States concerned. 3. Classified information received shall be handled by EUNAVFOR MED IRINI without any distinction between its staff and solely on the basis of operational requirements. 4. The HR shall also be authorised to release to the UN, in accordance with the operational needs of EUNAVFOR MED IRINI, EU classified information up to ‘RESTREINT UE/EU RESTRICTED’ level which are generated for the purposes of EUNAVFOR MED IRINI, in accordance with Decision 2013/488/EU. 5. The HR shall be authorised to release to INTERPOL relevant information, including personal data, in accordance with the operational needs of EUNAVFOR MED IRINI. 6. Pending the conclusion of an agreement between the Union and INTERPOL, EUNAVFOR MED IRINI may exchange such information with the National Central Bureaux of INTERPOL of the Member States, in accordance with arrangements to be concluded between the EU Operation Commander and the Head of the relevant National Central Bureau. 7. In the event of specific operational need, the HR shall be authorised, following approval by the PSC, to release to legitimate Libyan authorities any EU classified information up to ‘RESTREINT UE/EU RESTRICTED’ level generated for the purposes of EUNAVFOR MED IRINI, in accordance with Decision 2013/488/EU. 8. The HR shall be authorised to conclude the arrangements necessary to implement the provisions on information exchange in this Decision. 9. The HR may delegate the authorisations to release information as well as the ability to conclude the arrangements referred to in this Decision to EEAS officials, to the EU Operation Commander or to the EU Force Commander in accordance with section VII of Annex VI to Decision 2013/488/EU. 10. EUNAVFOR MED IRINI shall transmit without delay to the UN, in accordance with UNSCR 2509 (2020), the information gathered on suspected incidents of non-compliance with the UN arms embargo on Libya as provided in UNSCR 1970 (2011) and subsequent Resolutions, in particular UNSCRs 2292 (2016) and 2473 (2019), as well as the information gathered on suspected incidents of non-compliance with the UN measures to prevent illicit exports of petroleum from Libya as provided in UNSCR 2146 (2014) and subsequent Resolutions. Article 15 Entry into force and termination 1. This Decision shall enter into force on the date of its adoption. 2. EUNAVFOR MED IRINI shall end on 31 March 2021. 3. This Decision shall be repealed as from the date of closure of the EU Operation Headquarters in accordance with the plans approved for the termination of EUNAVFOR MED IRINI and without prejudice to the procedures regarding the audit and presentation of the accounts of EUNAVFOR MED IRINI laid down in Decision (CFSP) 2015/528. Done at Brussels, 31 March 2020. For the Council The President A. METELKO-ZGOMBIĆ (1) Council Decision (CFSP) 2015/778 of 18 May 2015 on a European Union military operation in the Southern Central Mediterranean (EUNAVFOR MED operation SOPHIA) (OJ L 122, 19.5.2015, p. 31). (2) Council Decision (CFSP) 2019/1595 of 26 September 2019 amending Decision (CFSP) 2015/778 on a European Union military operation in the Southern Central Mediterranean (EUNAVFOR MED operation SOPHIA) (OJ L 248, 27.9.2019, p. 73). (3) Council Decision (CFSP) 2015/528 of 27 March 2015 establishing a mechanism to administer the financing of the common costs of European Union operations having military or defence implications (Athena) and repealing Decision 2011/871/CFSP (OJ L 84, 28.3.2015, p. 39). (4) Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1). (5) Council Decision 2009/937/EU of 1 December 2009 adopting the Council’s Rules of Procedure (OJ L 325, 11.12.2009, p. 35).

A European Union military operation in the Mediterranean (European Union Naval Force Mediterranean operation IRINI) A European Union military operation in the Mediterranean (European Union Naval Force Mediterranean operation IRINI) SUMMARY OF: Decision (CFSP) 2020/472 on a European Union military operation in the Mediterranean WHAT IS THE AIM OF THE DECISION? It sets up European Union Naval Force Mediterranean (EUNAVFOR MED) operation IRINI (Greek for ‘peace’), whose primary role is to implement the arms embargo on Libya established by United Nations Security Council Resolutions 1970 (2011), 2292 (2016) and 2473 (2019) by using its military aerial, satellite and maritime resources. Operation IRINI’s secondary tasks are to: prevent the illegal export of oil from Libya;train and develop the Libyan coast guard and navy in their law enforcement duties, particularly against human smuggling and trafficking;help clamp down on human smuggling and trafficking by gathering information and patrolling the high seas. KEY POINTS To implement the arms embargo, operation IRINI: monitors and gathers information on illegal exports of arms and related material, petroleum, crude oil and refined petroleum products; inspects vessels to and from Libya suspected of carrying arms; seizes and disposes of any weapons found; collects personal data of people found trafficking; shares information it gathers with the relevant national, EU and international authorities; may divert vessels breaking the arms embargo to a specified port; establishes a crime information cell of national and EU law enforcement authorities to handle and process the information collected. Decision (CFSP) 2021/542 amends Decision (CFSP) 2020/472 and specifies the arrangements for disposing of arms and related military equipment seized when implementing the United Nations (UN) arms embargo on Libya, including the storage, destruction and transfer of seized items to an EU Member State or to a third party. The European Peace Facility, set up under Decision (CFSP) 2021/509 – see summary – bears the costs for storage and disposal of arms and related military equipment seized by operation IRINI within its area of operations, including costs related to the necessary port services. The facility also bears the costs for any financial liability resulting from the diversion of a vessel or from subsequent actions related to the transportation, storage and disposal of the seized items, except in cases of gross negligence or wilful misconduct by the Member State assisting in the disposal or by any of its agents. The political control and strategic direction of operation IRINI are provided by the following. The Political and Security Committee, which reconfirms authorisation of the operation every 4 months and reports regularly to EU governments. The EU Military Committee (set up by Decision 2001/79/CFSP), which monitors the operation. The High Representative of the Union for Foreign Affairs and Security Policy, who: ensures IRINI is consistent with the EU’s overall foreign policy, including its development programmes and humanitarian assistance;acts as main contact point with the UN and other international and bilateral actors, including countries in the region;may share EU classified and non-classified information with non-EU countries and bodies, such as the International Criminal Court, the UN and Interpol. Operation IRINI’s initial mandate ran until 31 March 2021. Amending Decision (CFSP) 2021/542 extended the mandate until 31 March 2023. Operation IRINI’s operational headquarters are in Rome under the command of Rear Admiral Stefano Turchetto. FROM WHEN DOES THE DECISION APPLY? It has applied since 31 March 2020. BACKGROUND At the Berlin Conference on Libya of 19 January 2020 participants committed to fully respecting and implementing the arms embargo imposed by various UN Security Council resolutions. EU Member States agreed on 17 February 2020 to launch a new operation in the Mediterranean to implement the UN arms embargo. At the same time, the EU agreed by Decision (CFSP) 2020/471 to end the EUNAVFOR MED operation Sophia on 31 March 2020. This operation had been launched on 22 June 2015 as part of the EU’s overall approach to migration. For further information, see: EU launches operation IRINI to enforce Libya arms embargo – press release (Council of the European Union). MAIN DOCUMENT Council Decision (CFSP) 2020/472 of 31 March 2020 on a European Union military operation in the Mediterranean (EUNAVFOR MED IRINI) (OJ L 101, 1.4.2020, pp. 4–10). Successive amendments to Decision (CFSP) 2020/472 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Council Decision (CFSP) 2021/509 of 22 March 2021 establishing a European Peace Facility, and repealing Decision (CFSP) 2015/528 (OJ L 102, 24.3.2021, pp. 14–62). Council Decision (CFSP) 2020/471 of 31 March 2020 repealing Decision (CFSP) 2015/778 on a European Union military operation in the Southern Central Mediterranean (EUNAVFOR MED operation SOPHIA) (OJ L 101, 1.4.2020, p. 3). last update 11.01.2022

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20.10.2020 EN Official Journal of the European Union L 348/1 COUNCIL DECISION (CFSP) 2020/1515 of 19 October 2020 establishing a European Security and Defence College, and repealing Decision (CFSP) 2016/2382 THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on European Union, and in particular Articles 28(1) and 42(4) thereof, Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy, Whereas: (1) On 18 July 2005, the Council adopted Joint Action 2005/575/CFSP (1) establishing the European Security and Defence College ('ESDC'). That Joint Action was replaced on 23 June 2008 by Council Joint Action 2008/550/CFSP (2), which, in turn, was replaced by Council Decision 2013/189/CFSP (3). Finally, Decision 2013/189/CFSP was replaced by Council Decision (CFSP) 2016/2382 (4). (2) On 10 and 11 November 2008, the Council adopted the European Young Officers Exchange Scheme, inspired by the Erasmus programme and agreed that an implementing working party will meet within the framework of the Executive Academic Board of the ESDC. (3) On 26 June 2020, the ESDC Steering Committee ('Steering Committee') agreed on recommendations on the future perspectives of the ESDC. (4) Whilst the staff of the ESDC should consist mainly of seconded national experts, it may be necessary to fill certain critical posts by contracted staff members. (5) Pursuant to Council Decision 2010/427/EU (5), which establishes the organisation and functioning of the European External Action Service (EEAS), the EEAS should provide the ESDC with the support previously provided by the General Secretariat of the Council. (6) Decision (CFSP) 2016/2382 should therefore be repealed, HAS ADOPTED THIS DECISION: CHAPTER I Establishment, mission, objectives and tasks Article 1 Establishment A European Security and Defence College (ESDC) is hereby established. Article 2 Mission The ESDC shall provide training and education in the field of the Union's Common Security and Defence Policy (CSDP) in the wider context of the Common Foreign and Security Policy (CFSP) at European level in order to develop and promote a common understanding of CFSP and CSDP among civilian and military personnel and to identify and disseminate best practices in relation to various CFSP and CSDP, issues through its training and education activities ('ESDC training and education activities'). Article 3 Objectives The ESDC shall have the following objectives: (a) to further enhance the common European security and defence culture within the Union and to promote the principles laid down in Article 21(1) of the Treaty on European Union (TEU) outside the Union; (b) to promote a better understanding of CSDP as an essential part of CFSP; (c) to provide Union instances with knowledgeable personnel able to work efficiently on all CSDP matters within the wider context of CFSP; (d) to provide Member States' administrations and staff with knowledgeable personnel familiar with Union policies, institutions and procedures in the field of CSDP; (e) to provide CSDP Missions' and Operations' personnel with a common understanding of CSDP Missions' and Operations' functioning principles and a sense of common European identity; (f) to provide training and education responding to training and educational needs of CSDP Missions and Operations; (g) to support Union partnerships in the field of CSDP, in particular partnerships with those countries participating in CSDP missions; (h) to support civilian crisis management including in the field of conflict prevention, and establishing or preserving the conditions necessary for sustainable development; (i) to promote the European Initiative for the Exchange of Young Officers; (j) to promote PhD-level research in domains related to CSDP; (k) to provide Member States' and Union administrations with knowledgeable personnel familiar with Union policies, institutions, procedures and best practices in the field of cyber security and defence; (l) to help promote professional relations and contacts among training and education participants. Where appropriate, attention shall be paid to ensuring consistency with other activities of the Union. Article 4 Tasks of the ESDC 1. The main tasks of the ESDC shall be, in accordance with its mission and objectives, to organise and conduct ESDC training and education activities in the field of the CSDP in the wider context of CFSP. 2. The ESDC training and education activities shall include: (a) basic and advanced level courses promoting generic understanding of CFSP and CSDP; (b) courses developing leadership; (c) courses directly supporting CSDP Missions and Operations, including pre‐deployment and in-mission/in-operation training and education; (d) courses supporting EU partnerships and countries participating in CSDP Missions and Operations; (e) modules supporting civilian and military training and education in the field of CSDP; (f) CSDP courses, seminars, programmes and conferences for specialised audiences or with specific focus; (g) common modules run under the European Initiative for the Exchange of Young Officers, inspired by the Erasmus programme; although formally not ESDC training and education activities, the ESDC will also support and promote European semesters and joint master's degrees making use of the common modules referred to in this point; (h) cyber awareness and advanced level courses, including in support of CSDP missions and operations; (i) courses and seminars aimed at supporting PhD-level research through exchange of best practices and experience. Other training and education activities shall be undertaken, as decided by the Steering Committee referred to in Article 9. 3. In addition to the activities referred to in paragraph 2 of this Article, the ESDC shall, in particular: (a) support the relations to be established between the institutes referred to in Article 5(1) engaged in the network referred to in that paragraph ('the network'); (b) run and further develop an e-Learning system to support CSDP training and education activities or, in exceptional circumstances, be used as stand-alone training and education activities; (c) develop and produce training and educational material in the field of CSDP also drawing on already existing relevant material; (d) support an Alumni Association between former training participants; (e) support exchange programmes in the field of CSDP between the Member States' training and educational institutes; (f) act as compartment administrator of the Schoolmaster module of the Goalkeeper project and provide contributions to the annual Union Training Programme in CSDP through this module; (g) act as administrator of the Union-instance of the CD-TXP platform for the exchange of cyber related training opportunities; (h) provide support to the management of training and education in the field of conflict prevention, civilian crisis management, establishing or preserving the conditions necessary for sustainable development and Security Sector Reform initiatives, as well as promotion of cyber security and hybrid threats' awareness; (i) organise and run an annual network conference bringing together civilian and military training and education experts in CFSP and CSDP from Member States' training and educational institutes and ministries, and relevant external training and education actors as appropriate; (j) maintain relationships with relevant actors in the field of Freedom Security and Justice, in the field of Development and Cooperation, and with relevant International Organisations; (k) support the Committee for Civilian Aspects of Crisis Management and the EU Civilian Training Group by administering and managing the travel and accommodation costs relating to the activities of the Civilian Coordinators for Training; (l) participate in the meetings of the Union civilian and military training groups, derive civilian/military training requirements from their output and take the results of the requirements analysis into account during the annual prioritisation exercise of ESDC activities and for the development of ESDC curricula; and (m) further elaborate, maintain and promote the sectoral qualification framework for military officers. CHAPTER II Organisation Article 5 Network 1. The ESDC shall be organised as a network bringing together civilian and military institutes, colleges, academies, universities, institutions, centres of excellence and other actors dealing with security and defence policy issues within the Union as identified by Member States, as well as the European Union Institute for Security Studies (EUISS). The ESDC shall establish close links with the Union institutions and relevant Union agencies, in particular with, but not limited to: — the Union Agency for law enforcement training (CEPOL), — the European Border and Coast Guard Agency (FRONTEX), — the European Defence Agency (EDA), — the European Satellite Centre (EU SatCen), and — the European Union Agency for Law Enforcement Cooperation (Europol). 2. Where appropriate, international, intergovernmental, governmental or non-governmental organisations may obtain the status of 'associate network partner' (ANP), the detailed arrangements for which will be agreed by the Steering Committee. 3. The ESDC shall work under the overall responsibility of the High Representative of the Union for Foreign Affairs and Security Policy ('HR'). Article 6 Role of European Union Institute for Security Studies 1. As part of the ESDC network, the EUISS shall cooperate with the ESDC by making its expertise and knowledge-gathering capabilities available for ESDC training activities, including through EUISS publications, within the limits of its own capabilities. 2. In particular, the EUISS shall provide lectures given by EUISS analysts and contribute to the further development of the ESDC e-Learning content. 3. The EUISS shall support the ESDC Alumni Association. Article 7 Legal capacity 1. The ESDC shall have the necessary legal capacity in order to: (a) fulfil its tasks and meet its objectives; (b) enter into contracts and administrative arrangements necessary for its functioning including to implement staff secondments and recruit contract staff; acquire equipment, in particular teaching equipment; (c) hold bank accounts; and (d) be a party to legal proceedings. 2. Any liability that may arise from contracts concluded by the ESDC, shall be covered by the funds available to it pursuant to Articles 16 and 17. Article 8 Structure The following structure shall be set up under the ESDC: (a) the Steering Committee with responsibility for the overall coordination and direction of the ESDC training and education activities; (b) the Executive Academic Board ('the Board') with responsibility for ensuring the quality and coherence of the ESDC training and education activities; (c) the Head of the ESDC ('the Head'), sole legal representative of the ESDC, with responsibility for the financial and administrative management of the ESDC, as well as advising the Steering Committee and the Board on the organisation and management of ESDC activities; (d) the ESDC Secretariat ('the Secretariat') which is to assist the Head in fulfilling the Head's tasks and in particular in assisting the Board to ensure the overall quality and coherence of the ESDC training and education activities. Article 9 Steering Committee 1. The Steering Committee shall be composed of one representative appointed by each Member State and shall be the decision-making body of the ESDC. Each member of the Committee may be represented or accompanied by an alternate member. 2. Members of the Steering Committee may be accompanied by experts to meetings of the Committee. 3. The Steering Committee shall be chaired by a representative of the HR who has appropriate experience. It shall meet at least four times a year. 4. Representatives from countries acceding to the Union may attend the Steering Committee's meetings as active observers. 5. The Head, other ESDC staff, the Chairperson of the Board and, when appropriate, the Chairpersons of its different configurations as well as a representative of the Commission and other Union institutions, including EEAS, shall participate in the meetings of the Steering Committee without the right to vote. 6. The tasks of the Steering Committee shall be to: (a) approve and keep under regular review the ESDC training and education activities reflecting the agreed CSDP training and education requirements; (b) approve the annual academic programme of the ESDC; (c) select and prioritise the training and education activities to be run under the ESDC, taking into account the resources made available to the ESDC and the training and education requirements identified; (d) select the Member State(s) hosting the ESDC training and education activities and the institutes conducting them; (e) decide on opening specific ESDC training and education activities to third- country participation within the general political framework set by the Political and Security Committee; (f) adopt the curricula for all ESDC training and education activities; (g) take note of the course evaluation reports; (h) take note of the general annual report on ESDC training and education activities and adopt the recommendations therein, to be forwarded to the relevant Council bodies; (i) provide overall guidance to the work of the Board; (j) appoint the Chairpersons of the Board and its different configurations; (k) take the necessary decisions with regard to the functioning of the ESDC in so far as these are not attributed to other bodies; (l) approve the annual budget and any amending budget, acting on proposals from the Head; (m) approve the annual accounts and give a discharge to the Head; (n) approve additional rules applicable to expenditure managed by the ESDC; (o) approve any financing agreement and/or technical arrangement with the Commission, the EEAS, a Union Agency or a Member State regarding the financing and/or the implementation of the ESDC expenditure; (p) contribute to the selection process of the Head as defined in Article 11(3); (q) evaluate the performance of his or her tasks by the Head as regards the potential extension of his or her mandate as referred in Article 11(4). 7. The Steering Committee shall approve its Rules of Procedure. 8. Except for the case provided for in Article 2(6) of the Financial Rules applicable to expenditure funded by the ESDC and to the financing of the expenditure of the ESDC, which are set out in the Annex to this Decision (the "Financial Rules"), the Steering Committee shall act by qualified majority, as defined in Article 16(4) TEU. Article 10 Executive Academic Board 1. The Board shall be composed of senior representatives from those civilian and military institutes and other actors identified by Member States to support the conduct of ESDC training and education activities and of the Director of EUISS or the Director's representative. 2. The Chairperson of the Board shall be appointed by the Steering Committee among the members of the Board. 3. Representatives of the Commission and of EEAS shall be invited to attend the meetings of the Board. 4. Senior representatives of the associate network partners shall be invited to attend the meetings of the Board as active observers. 5. Academic experts and senior officials from Union and national institutions may be invited to attend the meetings of the Board, as observers. When appropriate and on a case-by-case basis, academic experts and senior officials who are representatives of institutes that are not a member of the network may be invited to participate in the meetings of the Board. 6. The tasks of the Board shall be to: (a) provide academic advice and recommendations to the Steering Committee; (b) implement, through the network, the agreed annual academic programme; (c) oversee the e-Learning system; (d) develop curricula for all ESDC training and education activities; (e) ensure general coordination of ESDC training and education activities among all institutes; (f) review standards of the training and education activities undertaken in the previous academic year; (g) submit proposals to the Steering Committee for training and education activities in the next academic year; (h) ensure a systematic evaluation of all ESDC training and education activities and approve the course evaluation reports; (i) contribute to the draft general annual report on ESDC activities; (j) support the implementation of the European Initiative for the Exchange of Young Officers, inspired by the Erasmus programme. 7. To fulfil its tasks, the Board may meet in different project-focused configurations. The Board shall draw up the rules and arrangements governing the creation and functioning of these configurations to be agreed by the Steering Committee. Each configuration shall report its activities back to the overall Board at least once every year, after which its mandate may be extended. 8. Members of the Secretariat shall support and assist the Board and each of its configurations. Those members shall attend the meetings without the right to vote. If no other candidate can be identified, a member may, at the same time, chair the meetings. 9. The Rules of Procedure of the Board and each of its configurations shall be adopted by the Steering Committee. Article 11 Head of the ESDC 1. The Head shall: (a) be responsible for the ESDC activities; (b) be the sole legal representative of the ESDC; (c) be responsible for the financial and administrative management of the ESDC; (d) advise the Steering Committee and the Board and support their work; and (e) act as the representative of the ESDC for training and education activities within and outside the network. 2. Candidates for the position of Head shall be persons with recognised long‐standing expertise and experience in training and education. Member States may put forward candidates for the position of Head. Staff of the Union institutions and the EEAS may apply for this position, in accordance with the applicable rules. 3. The pre-selection process shall be organised under the responsibility of the HR. The pre-selection panel shall be composed of three representatives of the EEAS. It shall be chaired by the Chair of the Steering Committee. On the basis of the pre-selection results, the HR shall submit to that Committee a recommendation with a shortlist of at least three candidates, drawn-up in the order of the pre-selection panel's preference. At least half of the candidates on the shortlist should come from Member States. During the selection process, the candidates shall present their vision for the ESDC to that Committee, after which Member States shall be invited to rank the candidates in a written, secret vote. The Head shall be appointed by the HR as a member of the EEAS staff for a period not exceeding three years. 4. Before the end of the period referred to in paragraph 3, the performance of his or her tasks by the Head shall be evaluated by the Steering Committee, in particular against the objectives set in the vision he or she presented during the selection process. On the basis of this evaluation, that Committee shall then either propose to extend the mandate of the current head or to launch a new selection procedure to select a new Head. In the latter case, the current Head may not apply for that position. In case of extension, the total duration of the mandate of the Head shall not exceed five years. 5. The tasks of the Head shall in particular be to: (a) take all necessary steps, including the adoption of internal administrative instructions and the publication of notices, to ensure the effective functioning of ESDC activities; (b) draw up the preliminary draft annual report of the ESDC and its preliminary draft work programme to be submitted to the Steering Committee on the basis of the proposals submitted by the Board; (c) co-ordinate the implementation of the ESDC work programme; (d) maintain contacts with the relevant authorities in Member States; (e) maintain contacts with relevant external training and education actors in the field of CFSP and CSDP; (f) conclude where necessary technical arrangements on ESDC training and education activities with the relevant authorities and training and education actors in the field of CFSP and CSDP; (g) perform any other task attributed to him or her by the Steering Committee. 6. The Head shall be responsible for the financial and administrative management of the ESDC, and in particular shall: (a) draw up and submit to the Steering Committee any draft budget; (b) adopt the budgets after their approval by the Steering Committee; (c) be the authorising officer for the ESDC budget; (d) open one or more bank accounts on behalf of the ESDC; (e) negotiate, submit to the Steering Committee and conclude any financing agreement and/or technical arrangement with the Commission, the EEAS or a Member State regarding the financing and/or the implementation of the ESDC expenditure; (f) select the staff of the Secretariat, assisted by a selection panel; (g) negotiate and sign on behalf of the ESDC any Exchange of Letters for the secondment to the ESDC of Secretariat staff; (h) negotiate and sign on behalf of the ESDC any contract of employment for staff paid from the ESDC budget; (i) generally, represent the ESDC for the purpose of all legal acts with financial implications; (j) submit to the Steering Committee the ESDC annual accounts. 7. The Head shall be accountable to the Steering Committee for his or her activities. Article 12 ESDC Secretariat 1. The Secretariat shall assist the Head in fulfilling the tasks of the Head. 2. The Secretariat shall provide support to the Steering Committee, to the Board including its configurations and to institutes for the management, coordination and organisation of the ESDC training and education activities. 3. The Secretariat shall support and assist the Board in ensuring the overall quality and coherence of ESDC training and education activities and in ensuring that they remain in line with the Union's policy developments. In particular, they shall help to ensure that all steps in the delivery of a training and education activity, from curriculum development and the content to the methodologic approach, shall reflect the highest possible standards. 4. Each institute forming the ESDC network shall designate a point of contact with the Secretariat to deal with the organisational and administrative issues connected with the organisation of the ESDC training and education activities. 5. The Secretariat shall closely co-operate with the Commission and the EEAS. Article 13 ESDC Staff 1. The ESDC staff shall consist of: (a) staff seconded to the ESDC by Union institutions, the EEAS and Union agencies; (b) national experts seconded to the ESDC by Member States; (c) contracted staff when no national expert has been identified and following approval by the Steering Committee. 2. The ESDC may receive interns and visiting fellows. 3. The number of ESDC staff shall be decided by the Steering Committee together with the budget for the next year and have a clear link to the number of ESDC training and education activities and other tasks as defined in Article 4. 4. The Decision of the HR establishing the rules applicable to national experts seconded to the EEAS shall be applicable mutatis mutandis to national experts seconded to the ESDC by Member States. The Staff Regulations of Officials of the European Union and the Conditions for Employment of Other Servants of the European Union (6), shall apply for personnel seconded to the ESDC by Union institutions, including for contracted staff paid from the ESDC budget. 5. The Steering Committee, acting on a proposal from the HR, shall define in so far as necessary the conditions applicable to interns and visiting fellows. 6. ESDC staff cannot conclude contracts or engage in any kind of financial obligations on behalf of the ESDC without prior written authorisation by the Head. CHAPTER III Financing Article 14 Contributions in kind to training and education activities 1. Each Member State, Union institution, Union agency and institute, and EEAS shall bear all costs related to its participation in the ESDC, including salaries, allowances, travel and subsistence expenses and costs related to organisational and administrative support of the ESDC training and education activities. 2. Each participant in ESDC training and education activities shall bear all costs related to his or her participation. Article 15 Support by the EEAS 1. The EEAS shall bear the costs arising from the hosting of the Head and the Secretariat within its premises, including information technology costs, the secondment of the Head and the secondment of one assistant staff member to the Secretariat. 2. The EEAS shall provide the ESDC with the administrative support necessary to recruit and manage its staff and to implement its budget. Article 16 Contribution from the general budget of the European Union 1. The ESDC shall receive an annual or multi-annual contribution from the general budget of the European Union. That contribution may cover, in particular, costs of supporting training and education activities and the costs of national experts seconded by Member States to the ESDC and up to one contracted staff member. 2. The financial reference amount intended to cover the expenditure of the ESDC during the period from 1 January 2021 to 31 December 2021 shall be EUR 2 055 156. The financial reference amount intended to cover the expenditure of the ESDC for subsequent periods shall be decided by the Council. 3. Following the decision by the Council as referred to in paragraph 2, a financing agreement with the Commission shall be negotiated by the Head. Article 17 Voluntary contributions 1. For the purpose of financing specific activities, the ESDC may receive and manage voluntary contributions from Member States and institutes or other donors. Such contributions shall be specifically designated by the ESDC. 2. Technical arrangements for the contributions referred to in paragraph 1 shall be negotiated by the Head. Article 18 Implementation of projects 1. The ESDC can apply for research and other projects in the field of CFSP. The ESDC can act as a project coordinator or a member. The Head can be attached to the 'advisory board' of such a project. The Head may delegate this task to one of the Chairpersons of the Board configurations or to a member of the Secretariat. 2. Contribution coming from those projects has to be made visible in the amending budget of the ESDC and used according to the tasks and objectives of the ESDC. Article 19 Financial rules The Financial Rules shall apply to expenditure funded by the ESDC and to the financing of such expenditure. CHAPTER IV Miscellaneous provisions Article 20 Participation in ESDC training and education activities 1. All ESDC training and education activities shall be open to participation by nationals of all Member States and acceding States. The organising and conducting institutes shall ensure that this principle applies without any exception. 2. The ESDC training and education activities shall also be open in principle to participation by nationals of countries that are candidates for accession to the Union and, as appropriate, of other third States and organisations, in particular for those training and education activities referred to in point (d) of Article 4(2). 3. Participants shall be civilian/diplomatic/police/military personnel dealing with aspects in the field of CSDP and CFSP, and experts to be deployed in CSDP missions or operations. Representatives of, inter alia, international organisations, non-governmental organisations, academic institutions and the media, as well as members of the business community, may be invited to participate in ESDC training and education activities. 4. A certificate signed by the HR shall be awarded to a participant who has completed an ESDC course. The modalities of the certificate shall be kept under review by the Steering Committee. The certificate shall be recognised by Member States and by the Union institutions. Article 21 Cooperation The ESDC shall cooperate with and draw on the expertise of international organisations and other relevant actors, such as national training and education institutes of third States, in particular but not limited to those referred to in Article 5(2). Article 22 Security regulations Council Decision 2013/488/EU (7) shall apply to the ESDC. CHAPTER V Final provisions Article 23 Continuity The rules and regulations adopted for the implementation of Decision (CFSP) 2016/2382 shall remain in force for the purpose of implementing this Decision in so far as they are compatible with this Decision and until they are amended or repealed. Article 24 Repeal Decision (CFSP) 2016/2382 is hereby repealed. Article 25 Review 1. No later than 20 October 2024, the Head shall initiate a review of the training and education activities, consulting all stakeholders. 2. The review shall be submitted to the Steering Committee. Article 26 Entry into force This Decision shall enter into force upon the date of adoption. Article 27 Publication This Decision shall be published in the Official Journal of the European Union. Done at Luxembourg, 19 October 2020. For the Council The President J. KLOECKNER (1) Council Joint Action 2005/575/CFSP of 18 July 2005 establishing a European Security and Defence College (ESDC) (OJ L 194, 26.7.2005, p. 15). (2) Council Joint Action 2008/550/CFSP of 23 June 2008 establishing a European Security and Defence College (ESDC) and repealing Joint Action 2005/575/CFSP (OJ L 176, 4.7.2008, p. 20). (3) Council Decision 2013/189/CFSP of 22 April 2013 establishing a European Security and Defence College (ESDC) and repealing Joint Action 2008/550/CFSP (OJ L 112, 24.4.2013, p. 22). (4) Council Decision (CFSP) 2016/2382 of 21 December 2016 establishing a European Security and Defence College (ESDC) and repealing Decision 2013/189/CFSP (OJ L 352, 23.12.2016, p. 60). (5) Council Decision 2010/427/EU of 26 July 2010 establishing the organisation and functioning of the European External Action Service (OJ L 201, 3.8.2010, p. 30). (6) Regulation (EEC, Euratom, ECSC) No 259/68 of the Council of 29 February 1968 laying down the Staff Regulations of Officials and the Conditions for Employment of Other Servants of the European Communities and instituting special measures temporarily applicable to officials of the Commission (OJ L 56, 4.3.1968, p. 1). (7) Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1). ANNEX FINANCIAL RULES APPLICABLE TO EXPENDITURE FUNDED BY THE ESDC AND TO THE FINANCING OF THE EXPENDITURE OF THE ESDC Article 1 Budgetary principles 1. The ESDC budget, drawn up in euro, is the act which for each financial year lays down and authorises all the ESDC revenue and all expenditure funded by the ESDC. 2. Budget revenue and expenditure shall be in balance. 3. No revenue or expenditure funded by the ESDC may be implemented other than by allocation to a heading in the ESDC budget. Article 2 Adoption of budgets 1. Each year the Head shall draw up a draft budget for the following financial year, which begins on 1 January and ends on 31 December of the same year. The draft budget shall include the appropriations deemed necessary to cover the expenditure to be funded by the ESDC during that period and a forecast of the revenue expected to cover such expenditure. 2. Appropriations shall be classified as necessary by type or purpose in chapters and articles. Detailed comments by article shall be included in the draft. 3. Revenue shall consist of Member States' or other donors' voluntary contributions as well as the annual contribution from the general budget of the European Union. 4. The Head shall submit a detailed budget report on the previous financial year by 31 March. The Head shall propose the draft budget for the following financial year to the Steering Committee by 31 July. 5. The Steering Committee shall approve the draft budget by 31 October. 6. Where the ESDC receives a multi-annual contribution from the general budget of the European Union, the Steering Committee shall approve the annual budget by consensus. Article 3 Transfers of appropriations In the event of unforeseen circumstances, transfers of appropriations between budget lines or budget headings of the contribution referred to in Article 16, not exceeding 25 % of these budget lines or headings, may be decided by the Head, who shall keep the Steering Committee informed of such transfers. Transfers of appropriations between budget lines or headings exceeding 25 % of the budget lines or headings shall be submitted to the Steering Committee in an amending budget of the ESDC for approval. Article 4 Carryovers of appropriations 1. Appropriations necessary to pay for legal obligations entered into by 31 December of a financial year shall be carried over to the next financial year. 2. Appropriations coming from voluntary contributions shall be carried over to the next financial year. 3. Appropriations coming from projects shall be carried over to the next financial year. 4. The Head may carry over other appropriations in the budget to the next financial year with the approval of the Steering Committee. 5. Other appropriations shall be cancelled at the end of the financial year. Article 5 Implementation of the budget and staff management For the purpose of implementing its budget and managing its staff, the ESDC shall use existing administrative structures of the Union, in particular the EEAS, to the greatest possible extent. Article 6 Bank accounts 1. Any ESDC bank account shall be opened at a first-rate financial institution with its head office in a Member State and shall be a current or short-term account in euro. 2. No ESDC bank account shall be overdrawn. Article 7 Payments Any payment from an ESDC bank account shall require the joint signature of the Head and another member of the ESDC staff. Article 8 Accounting 1. The Head shall ensure that accounts showing the ESDC revenue, expenditure and inventory of assets are kept in accordance with the internationally accepted accounting standards for the public sector. 2. The Head shall submit to the Steering Committee the annual accounts for a given financial year no later than the following 31 March, together with the detailed report referred to in Article 2(4) of these Financial Rules. 3. If necessary, accounting services may be outsourced. Article 9 Auditing 1. An audit of the ESDC accounts shall be conducted annually. 2. The necessary auditing services shall be outsourced. 3. The audit reports shall be made available to the Steering Committee together with the detailed report referred to in Article 2(4) of these Financial Rules. Article 10 Discharge 1. The Steering Committee shall decide on the basis of the detailed report, the annual accounts and the annual audit report whether to grant the Head a discharge in respect of the implementation of the ESDC budget. 2. The Head shall take all appropriate steps to satisfy the Steering Committee that a discharge may be granted and to act on the observations in the decisions giving discharge, if any.

European Security and Defence College European Security and Defence College SUMMARY OF: Decision (CFSP) 2020/1515 establishing a European Security and Defence College WHAT IS THE AIM OF THE DECISION? The decision sets up the European Security and Defence College (ESDC), which aims to develop and promote a common understanding among civilians and military personnel of the common security and defence policy (CSDP) and the common foreign and security policy (CFSP) of the European Union (EU) through training and education activities. KEY POINTS Objectives The ESDC has a number of objectives, including: further enhancing the common European security and defence culture within the EU and promoting the principles set out in Article 21 of the Treaty on European Union; promoting a better understanding of CSDP as an essential part of CFSP; providing EU Member States’ administrations with people who are familiar with EU policies, institutions and procedures in the CSDP field; providing CSDP missions and operations personnel with a common understanding of the functioning principles and a sense of common European identity; providing training and education that meet the needs of CSDP missions and operations; supporting EU partnerships in the field of CSDP, in particular with those countries participating in CSDP missions; supporting civilian crisis management — including in the field of conflict prevention — and establishing or preserving the conditions necessary for sustainable development; promoting the European initiative for the exchange of young officers; helping to promote professional relations and contacts among the participants. Tasks of the ESDC The main task of the ESDC is to provide training and education. The decision sets out a number of specific tasks, including: basic- and advanced-level courses that promote a generic understanding of CFSP and CSDP; leadership courses; courses that directly support CSDP missions and operations, including pre‐deployment and in-mission / in-operation training and education; courses that support EU partnerships and the countries participating in CSDP missions and operations; modules that support civilian and military training and education in the field of CSDP; CSDP courses, seminars, programmes and conferences for specialised audiences; common modules that run under the European initiative for the exchange of young officers, which was inspired by the Erasmus+ programme; cyber awareness and advanced courses, including in support of CSDP missions and operations; courses and seminars that support PhD-level research through the exchange of best practices and experience. Network The ESDC is organised as a network of various educational institutions — including those dealing with security and defence policies within the EU, as identified by the Member States — and the European Union Institute for Security Studies. The ESDC is closely linked with several EU institutions and agencies, including: the European Border and Coast Guard Agency — Regulation (EU) 2019/1896, see summary; the EU Agency for Law Enforcement Cooperation (Europol) — Regulation (EU) 2016/794, see summary; the EU Agency for Law Enforcement Training — Regulation (EU) 2015/2219, see summary; the European Defence Agency — Decision (CFSP) 2015/1835, see summary; the European Union Satellite Centre — Decision 2014/401/CFSP, see summary.. The ESDC is under the overall responsibility of the High Representative of the Union for Foreign Affairs and Security Policy. FROM WHEN DOES THE DECISION APPLY? It has applied since 19 October 2020. Council Decision (CFSP) 2020/1515 repeals Council Decision (CFSP) 2016/2382. BACKGROUND For further information, see: European Security and Defence College (European Commission). MAIN DOCUMENT Council Decision (CFSP) 2020/1515 of 19 October 2020 establishing a European Security and Defence College, and repealing Decision (CFSP) 2016/2382 (OJ L 348, 20.10.2020, pp. 1–14). Successive amendments to Decision (CFSP) 2020/1515 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ L 295, 14.11.2019, pp. 1–131). Consolidated version of the Treaty on European Union — Title V — General Provisions on the Union’s External Action and Specific Provisions on the Common Foreign and Security Policy — Chapter 2 — Specific Provisions on the common foreign and security policy — Section 1 — Common provisions — Article 28 (ex Article 14 TEU) (OJ C 202, 7.6.2016, p. 32). Consolidated version of the Treaty on European Union — Title V — General Provisions on the Union’s External Action and Specific Provisions on the Common Foreign and Security Policy — Chapter 2 — Specific Provisions on the common foreign and security policy — Section 2 — Provisions on the common security and defence policy — Article 42 (ex Article 17 TEU) (OJ C 202, 7.6.2016, pp. 38–39). Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, pp. 53–114). Regulation (EU) 2015/2219 of the European Parliament and of the Council of 25 November 2015 on the European Union Agency for Law Enforcement Training (CEPOL) and replacing and repealing Council Decision 2005/681/JHA (OJ L 319, 4.12.2015, pp. 1–20). Council Decision (CFSP) 2015/1835 of 12 October 2015 defining the statute, seat and operational rules of the European Defence Agency (OJ L 266, 13.10.2015, pp. 55–74). See consolidated version. Council Decision 2014/75/CFSP of 10 February 2014 on the European Union Institute for Security Studies (OJ L 41, 12.2.2014, pp. 13–17). last update 08.12.2021

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11.3.2011 EN Official Journal of the European Union L 65/1 REGULATION (EU) No 211/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 February 2011 on the citizens’ initiative THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular the first paragraph of Article 24 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The Treaty on European Union (TEU) reinforces citizenship of the Union and enhances further the democratic functioning of the Union by providing, inter alia, that every citizen is to have the right to participate in the democratic life of the Union by way of a European citizens’ initiative. That procedure affords citizens the possibility of directly approaching the Commission with a request inviting it to submit a proposal for a legal act of the Union for the purpose of implementing the Treaties similar to the right conferred on the European Parliament under Article 225 of the Treaty on the Functioning of the European Union (TFEU) and on the Council under Article 241 TFEU. (2) The procedures and conditions required for the citizens’ initiative should be clear, simple, user-friendly and proportionate to the nature of the citizens’ initiative so as to encourage participation by citizens and to make the Union more accessible. They should strike a judicious balance between rights and obligations. (3) They should also ensure that citizens of the Union are subject to similar conditions for supporting a citizens’ initiative regardless of the Member State from which they come. (4) The Commission should, upon request, provide citizens with information and informal advice about citizens’ initiatives, notably as regards the registration criteria. (5) It is necessary to establish the minimum number of Member States from which citizens must come. In order to ensure that a citizens’ initiative is representative of a Union interest, while ensuring that the instrument remains easy to use, that number should be set at one quarter of Member States. (6) For that purpose, it is also appropriate to establish the minimum number of signatories coming from each of those Member States. In order to ensure similar conditions for citizens to support a citizens’ initiative, those minimum numbers should be degressively proportional. For the purpose of clarity, those minimum numbers should be set out for each Member State in an annex to this Regulation. The minimum number of signatories required in each Member State should correspond to the number of Members of the European Parliament elected in each Member State, multiplied by 750. The Commission should be empowered to amend that annex in order to reflect any modification in the composition of the European Parliament. (7) It is appropriate to fix a minimum age for supporting a citizens’ initiative. That should be set as the age at which citizens are entitled to vote in elections to the European Parliament. (8) A minimum organised structure is needed in order to successfully carry through a citizens’ initiative. That should take the form of a citizens’ committee, composed of natural persons (organisers) coming from at least seven different Member States, in order to encourage the emergence of European-wide issues and to foster reflection on those issues. For the sake of transparency and smooth and efficient communication, the citizens’ committee should designate representatives to liaise between the citizens’ committee and the institutions of the Union throughout the procedure. (9) Entities, notably organisations which under the Treaties contribute to forming European political awareness and to expressing the will of citizens of the Union, should be able to promote a citizens’ initiative, provided that they do so with full transparency. (10) In order to ensure coherence and transparency in relation to proposed citizens’ initiatives and to avoid a situation where signatures are being collected for a proposed citizens’ initiative which does not comply with the conditions laid down in this Regulation, it should be mandatory to register such initiatives on a website made available by the Commission prior to collecting the necessary statements of support from citizens. All proposed citizens’ initiatives that comply with the conditions laid down in this Regulation should be registered by the Commission. The Commission should deal with registration in accordance with the general principles of good administration. (11) Once a proposed citizens’ initiative is registered, statements of support from citizens may be collected by the organisers. (12) It is appropriate to set out the form for the statement of support in an annex to this Regulation, specifying the data required for the purposes of verification by the Member States. The Commission should be empowered to amend that annex in accordance with Article 290 TFEU, taking into account information forwarded to it by Member States. (13) With due respect for the principle that personal data must be adequate, relevant and not excessive in relation to the purposes for which they are collected, the provision of personal data, including, where applicable, a personal identification number or a personal identification document number by signatories of a proposed citizens’ initiative is required as far as may be necessary in order to allow for the verification of statements of support by Member States, in accordance with national law and practice. (14) In order to put modern technology to good use as a tool of participatory democracy, it is appropriate to provide for statements of support to be collected online as well as in paper form. Online collection systems should have adequate security features in place in order to ensure, inter alia, that the data are securely collected and stored. For that purpose, the Commission should set out detailed technical specifications for online collection systems. (15) It is appropriate for Member States to verify the conformity of online collection systems with the requirements of this Regulation before statements of support are collected. (16) The Commission should make available an open-source software incorporating the relevant technical and security features necessary in order to comply with the provisions of this Regulation as regards online collection systems. (17) It is appropriate to ensure that statements of support for a citizens’ initiative are collected within a specific time limit. In order to ensure that proposed citizens’ initiatives remain relevant, whilst taking account of the complexity of collecting statements of support across the Union, that time limit should not be longer than 12 months from the date of registration of the proposed citizens’ initiative. (18) It is appropriate to provide that, where a citizens’ initiative has received the necessary statements of support from signatories, each Member State should be responsible for the verification and certification of statements of support collected from signatories coming from that Member State. Taking account of the need to limit the administrative burden for Member States, they should, within a period of three months from receipt of a request for certification, carry out such verifications on the basis of appropriate checks, which may be based on random sampling, and should issue a document certifying the number of valid statements of support received. (19) Organisers should ensure that all the relevant conditions set out in this Regulation are met prior to submitting a citizens’ initiative to the Commission. (20) The Commission should examine a citizens’ initiative and set out its legal and political conclusions separately. It should also set out the action it intends to take in response to it, within a period of three months. In order to demonstrate that a citizens’ initiative supported by at least one million Union citizens and its possible follow-up are carefully examined, the Commission should explain in a clear, comprehensible and detailed manner the reasons for its intended action, and should likewise give its reasons if it does not intend to take any action. When the Commission has received a citizens’ initiative supported by the requisite number of signatories which fulfils the other requirements of this Regulation, the organisers should be entitled to present that initiative at a public hearing at Union level. (21) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (4) is fully applicable to the processing of personal data carried out in application of this Regulation. In this respect, for the sake of legal certainty, it is appropriate to clarify that the organisers of a citizens’ initiative and the competent authorities of the Member States are the data controllers within the meaning of Directive 95/46/EC and to specify the maximum period within which the personal data collected for the purposes of a citizens’ initiative may be retained. In their capacity as data controllers, organisers need to take all the appropriate measures to comply with the obligations imposed by Directive 95/46/EC, in particular those relating to the lawfulness of the processing, the security of the processing activities, the provision of information and the rights of data subjects to have access to their personal data, as well as to procure the correction and erasure of their personal data. (22) The provisions of Chapter III of Directive 95/46/EC on judicial remedies, liability and sanctions are fully applicable as regards the data processing carried out in application of this Regulation. Organisers of a citizens’ initiative should be liable in accordance with applicable national law for any damage that they cause. In addition, Member States should ensure that organisers are subject to appropriate penalties for infringements of this Regulation. (23) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (5) is fully applicable to the processing of personal data carried out by the Commission in application of this Regulation. (24) In order to address future adaptation needs, the Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU for the purpose of amending the Annexes to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. (25) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6). (26) This Regulation respects fundamental rights and observes the principles enshrined in the Charter of Fundamental Rights of the European Union, in particular Article 8 thereof, which states that everyone has the right to the protection of personal data concerning him or her. (27) The European Data Protection Supervisor was consulted and adopted an opinion (7), HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes the procedures and conditions required for a citizens’ initiative as provided for in Article 11 TEU and Article 24 TFEU. Article 2 Definitions For the purpose of this Regulation the following definitions shall apply: 1. ‘citizens’ initiative’ means an initiative submitted to the Commission in accordance with this Regulation, inviting the Commission, within the framework of its powers, to submit any appropriate proposal on matters where citizens consider that a legal act of the Union is required for the purpose of implementing the Treaties, which has received the support of at least one million eligible signatories coming from at least one quarter of all Member States; 2. ‘signatories’ means citizens of the Union who have supported a given citizens’ initiative by completing a statement of support form for that initiative; 3. ‘organisers’ means natural persons forming a citizens’ committee responsible for the preparation of a citizens’ initiative and its submission to the Commission. Article 3 Requirements for organisers and for signatories 1. The organisers shall be citizens of the Union and be of the age to be entitled to vote in elections to the European Parliament. 2. The organisers shall form a citizens’ committee of at least seven persons who are residents of at least seven different Member States. The organisers shall designate one representative and one substitute (‘the contact persons’), who shall liaise between the citizens’ committee and the institutions of the Union throughout the procedure and who shall be mandated to speak and act on behalf of the citizens’ committee. Organisers who are Members of the European Parliament shall not be counted for the purposes of reaching the minimum number required to form a citizens’ committee. For the purpose of registering a proposed citizens’ initiative in accordance with Article 4, only the information concerning the seven members of the citizens’ committee who are needed in order to comply with the requirements laid down in paragraph 1 of this Article and in this paragraph shall be considered by the Commission. 3. The Commission may request the organisers to provide appropriate proof that the requirements laid down in paragraphs 1 and 2 are fulfilled. 4. In order to be eligible to support a proposed citizens’ initiative, signatories shall be citizens of the Union and shall be of the age to be entitled to vote in elections to the European Parliament. Article 4 Registration of a proposed citizens’ initiative 1. Prior to initiating the collection of statements of support from signatories for a proposed citizens’ initiative, the organisers shall be required to register it with the Commission, providing the information set out in Annex II, in particular on the subject matter and objectives of the proposed citizens’ initiative. That information shall be provided in one of the official languages of the Union, in an online register made available for that purpose by the Commission (‘the register’). The organisers shall provide, for the register and where appropriate on their website, regularly updated information on the sources of support and funding for the proposed citizens’ initiative. After the registration is confirmed in accordance with paragraph 2, the organisers may provide the proposed citizens’ initiative in other official languages of the Union for inclusion in the register. The translation of the proposed citizens’ initiative into other official languages of the Union shall be the responsibility of the organisers. The Commission shall establish a point of contact which provides information and assistance. 2. Within two months from the receipt of the information set out in Annex II, the Commission shall register a proposed citizens’ initiative under a unique registration number and send a confirmation to the organisers, provided that the following conditions are fulfilled: (a) the citizens’ committee has been formed and the contact persons have been designated in accordance with Article 3(2); (b) the proposed citizens’ initiative does not manifestly fall outside the framework of the Commission’s powers to submit a proposal for a legal act of the Union for the purpose of implementing the Treaties; (c) the proposed citizens’ initiative is not manifestly abusive, frivolous or vexatious; and (d) the proposed citizens’ initiative is not manifestly contrary to the values of the Union as set out in Article 2 TEU. 3. The Commission shall refuse the registration if the conditions laid down in paragraph 2 are not met. Where it refuses to register a proposed citizens’ initiative, the Commission shall inform the organisers of the reasons for such refusal and of all possible judicial and extrajudicial remedies available to them. 4. A proposed citizens’ initiative that has been registered shall be made public in the register. Without prejudice to their rights under Regulation (EC) No 45/2001, data subjects shall be entitled to request the removal of their personal data from the register after the expiry of a period of two years from the date of registration of a proposed citizens’ initiative. 5. At any time before the submission of statements of support in accordance with Article 8, the organisers may withdraw a proposed citizens’ initiative that has been registered. In that case, an indication to that effect shall be entered in the register. Article 5 Procedures and conditions for the collection of statements of support 1. The organisers shall be responsible for the collection of the statements of support from signatories for a proposed citizens’ initiative which has been registered in accordance with Article 4. Only forms which comply with the models set out in Annex III and which are in one of the language versions included in the register for that proposed citizens’ initiative may be used for the collection of statements of support. The organisers shall complete the forms as indicated in Annex III prior to initiating the collection of statements of support from signatories. The information given in the forms shall correspond to the information contained in the register. 2. The organisers may collect statements of support in paper form or electronically. Where statements of support are collected online, Article 6 shall apply. For the purpose of this Regulation, statements of support which are electronically signed using an advanced electronic signature, within the meaning of Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures (8), shall be treated in the same way as statements of support in paper form. 3. Signatories shall be required to complete statement of support forms made available by the organisers. They shall indicate only the personal data that are required for the purposes of verification by the Member States, as set out in Annex III. Signatories may only support a given proposed citizens’ initiative once. 4. Member States shall forward to the Commission any changes to the information set out in Annex III. Taking into account those changes, the Commission may adopt, by means of delegated acts, in accordance with Article 17 and subject to the conditions of Articles 18 and 19, amendments to Annex III. 5. All statements of support shall be collected after the date of registration of the proposed citizens’ initiative and within a period not exceeding 12 months. At the end of that period, the register shall indicate that the period has expired and, where appropriate, that the required number of statements of support was not collected. Article 6 Online collection systems 1. Where statements of support are collected online, the data obtained through the online collection system shall be stored in the territory of a Member State. The online collection system shall be certified in accordance with paragraph 3 in the Member State in which the data collected through the online collection system will be stored. The organisers may use one online collection system for the purpose of collecting statements of support in several or all Member States. The models for the statement of support forms may be adapted for the purpose of the online collection. 2. The organisers shall ensure that the online collection system used for the collection of statements of support complies with paragraph 4. Prior to initiating the collection of statements of support, the organisers shall request the competent authority of the relevant Member State to certify that the online collection system used for that purpose complies with paragraph 4. The organisers may only start collecting statements of support through the online collection system once they have obtained the certificate referred to in paragraph 3. The organisers shall make a copy of that certificate publicly available on the website used for the online collection system. By 1 January 2012, the Commission shall set up and thereafter shall maintain open-source software incorporating the relevant technical and security features necessary for compliance with the provisions of this Regulation regarding the online collection systems. The software shall be made available free of charge. 3. Where the online collection system complies with paragraph 4, the relevant competent authority shall within one month issue a certificate to that effect in accordance with the model set out in Annex IV. Member States shall recognise the certificates issued by the competent authorities of other Member States. 4. Online collection systems shall have adequate security and technical features in place in order to ensure that: (a) only natural persons may submit a statement of support form online; (b) the data provided online are securely collected and stored, in order to ensure, inter alia, that they may not be modified or used for any purpose other than their indicated support of the given citizens’ initiative and to protect personal data against accidental or unlawful destruction or accidental loss, alteration or unauthorised disclosure or access; (c) the system can generate statements of support in a form complying with the models set out in Annex III, in order to allow for the verification by the Member States in accordance with Article 8(2). 5. By 1 January 2012, the Commission shall adopt technical specifications for the implementation of paragraph 4, in accordance with the regulatory procedure referred to in Article 20(2). Article 7 Minimum number of signatories per Member State 1. The signatories of a citizens’ initiative shall come from at least one quarter of Member States. 2. In at least one quarter of Member States, signatories shall comprise at least the minimum number of citizens set out, at the time of registration of the proposed citizens’ initiative, in Annex I. Those minimum numbers shall correspond to the number of the Members of the European Parliament elected in each Member State, multiplied by 750. 3. The Commission shall adopt, by means of delegated acts, in accordance with Article 17 and subject to the conditions of Articles 18 and 19, appropriate adjustments to Annex I in order to reflect any modification in the composition of the European Parliament. 4. Signatories shall be considered as coming from the Member State which is responsible for the verification of their statement of support in accordance with the second subparagraph of Article 8(1). Article 8 Verification and certification by Member States of statements of support 1. After collecting the necessary statements of support from signatories in accordance with Articles 5 and 7, the organisers shall submit the statements of support, in paper or electronic form, to the relevant competent authorities referred to in Article 15 for verification and certification. For that purpose the organisers shall use the form set out in Annex V and shall separate those statements of support collected in paper form, those which were electronically signed using an advanced electronic signature and those collected through an online collection system. The organisers shall submit statements of support to the relevant Member State as follows: (a) to the Member State of residence or of nationality of the signatory, as specified in point 1 of Part C of Annex III, or (b) to the Member State that issued the personal identification number or the personal identification document indicated in the statement of support, as specified in point 2 of Part C of Annex III. 2. The competent authorities shall, within a period not exceeding three months from receipt of the request, verify the statements of support submitted on the basis of appropriate checks, in accordance with national law and practice, as appropriate. On that basis they shall deliver to the organisers a certificate in accordance with the model set out in Annex VI, certifying the number of valid statements of support for the Member State concerned. For the purpose of the verification of statements of support, the authentication of signatures shall not be required. 3. The certificate provided for in paragraph 2 shall be issued free of charge. Article 9 Submission of a citizens’ initiative to the Commission After obtaining the certificates provided for in Article 8(2), and provided that all relevant procedures and conditions set out in this Regulation have been complied with, the organisers may submit the citizens’ initiative to the Commission, accompanied by information regarding any support and funding received for that initiative. That information shall be published in the register. The amount of support and funding received from any source in excess of which information is to be provided shall be identical to that set out in Regulation (EC) No 2004/2003 of the European Parliament and of the Council of 4 November 2003 on the regulations governing political parties at European level and the rules regarding their funding (9). For the purpose of this Article, the organisers shall make use of the form set out in Annex VII and shall submit the completed form together with copies, in paper or electronic form, of the certificates provided for in Article 8(2). Article 10 Procedure for the examination of a citizens’ initiative by the Commission 1. Where the Commission receives a citizens’ initiative in accordance with Article 9 it shall: (a) publish the citizens’ initiative without delay in the register; (b) receive the organisers at an appropriate level to allow them to explain in detail the matters raised by the citizens’ initiative; (c) within three months, set out in a communication its legal and political conclusions on the citizens’ initiative, the action it intends to take, if any, and its reasons for taking or not taking that action. 2. The communication referred to in paragraph 1(c) shall be notified to the organisers as well as to the European Parliament and the Council and shall be made public. Article 11 Public hearing Where the conditions of Article 10(1)(a) and (b) are fulfilled, and within the deadline laid down in Article 10(1)(c), the organisers shall be given the opportunity to present the citizens’ initiative at a public hearing. The Commission and the European Parliament shall ensure that this hearing is organised at the European Parliament, if appropriate together with such other institutions and bodies of the Union as may wish to participate, and that the Commission is represented at an appropriate level. Article 12 Protection of personal data 1. In processing personal data pursuant to this Regulation, the organisers of a citizens’ initiative and the competent authorities of the Member State shall comply with Directive 95/46/EC and the national provisions adopted pursuant thereto. 2. For the purposes of their respective processing of personal data, the organisers of a citizens’ initiative and the competent authorities designated in accordance with Article 15(2) shall be considered as data controllers in accordance with Article 2(d) of Directive 95/46/EC. 3. The organisers shall ensure that personal data collected for a given citizen’s initiative are not used for any purpose other than their indicated support for that initiative, and shall destroy all statements of support received for that initiative and any copies thereof at the latest one month after submitting that initiative to the Commission in accordance with Article 9 or 18 months after the date of registration of the proposed citizens’ initiative, whichever is the earlier. 4. The competent authority shall use the personal data it receives for a given citizens’ initiative only for the purpose of verifying the statements of support in accordance with Article 8(2), and shall destroy all statements of support and copies thereof at the latest one month after issuing the certificate referred to in that Article. 5. Statements of support for a given citizens’ initiative and copies thereof may be retained beyond the time limits laid down in paragraphs 3 and 4 if necessary for the purpose of legal or administrative proceedings relating to a proposed citizen’s initiative. The organisers and the competent authority shall destroy all statements of support and copies thereof at the latest one week after the date of conclusion of the said proceedings by a final decision. 6. The organisers shall implement appropriate technical and organisational measures to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing. Article 13 Liability Organisers shall be liable for any damage they cause in the organisation of a citizens’ initiative in accordance with applicable national law. Article 14 Penalties 1. Member States shall ensure that organisers are subject to appropriate penalties for infringements of this Regulation and in particular for: (a) false declarations made by organisers; (b) the fraudulent use of data. 2. The penalties referred to in paragraph 1 shall be effective, proportionate and dissuasive. Article 15 Competent authorities within the Member States 1. For the purpose of the implementation of Article 6(3), Member States shall designate competent authorities responsible for issuing the certificate provided for therein. 2. For the purpose of the implementation of Article 8(2), each Member State shall designate one competent authority responsible for coordinating the process of verification of statements of support and for delivering the certificates provided for therein. 3. Not later than 1 March 2012, Member States shall forward the names and addresses of the competent authorities to the Commission. 4. The Commission shall make the list of competent authorities publicly available. Article 16 Amendment of the Annexes The Commission may adopt, by means of delegated acts in accordance with Article 17 and subject to the conditions of Articles 18 and 19, amendments to the Annexes to this Regulation within the scope of the relevant provisions of this Regulation. Article 17 Exercise of the delegation 1. The power to adopt the delegated acts referred to in Article 16 shall be conferred on the Commission for an indeterminate period of time. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 18 and 19. Article 18 Revocation of the delegation 1. The delegation of power referred to in Article 16 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 19 Objections to delegated acts 1. The European Parliament or the Council may object to the delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act. Article 20 Committee 1. For the purpose of the implementation of Article 6(5), the Commission shall be assisted by a committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. Article 21 Notification of national provisions Each Member State shall notify to the Commission the specific provisions it adopts in order to implement this Regulation. The Commission shall inform the other Member States thereof. Article 22 Review By 1 April 2015, and every three years thereafter, the Commission shall present a report to the European Parliament and the Council on the application of this Regulation. Article 23 Entry into force and application This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 1 April 2012. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 16 February 2011. For the European Parliament The President J. BUZEK For the Council The President MARTONYI J. (1) OJ C 44, 11.2.2011, p. 182. (2) OJ C 267, 1.10.2010, p. 57. (3) Position of the European Parliament of 15 December 2010 (not yet published in the Official Journal) and decision of the Council of 14 February 2011. (4) OJ L 281, 23.11.1995, p. 31. (5) OJ L 8, 12.1.2001, p. 1. (6) OJ L 184, 17.7.1999, p. 23. (7) OJ C 323, 30.11.2010, p. 1. (8) OJ L 13, 19.1.2000, p. 12. (9) OJ L 297, 15.11.2003, p. 1. ANNEX I MINIMUM NUMBER OF SIGNATORIES PER MEMBER STATE Belgium 16 500 Bulgaria 12 750 Czech Republic 16 500 Denmark 9 750 Germany 74 250 Estonia 4 500 Ireland 9 000 Greece 16 500 Spain 37 500 France 54 000 Italy 54 000 Cyprus 4 500 Latvia 6 000 Lithuania 9 000 Luxembourg 4 500 Hungary 16 500 Malta 3 750 Netherlands 18 750 Austria 12 750 Poland 37 500 Portugal 16 500 Romania 24 750 Slovenia 5 250 Slovakia 9 750 Finland 9 750 Sweden 13 500 United Kingdom 54 000 ANNEX II REQUIRED INFORMATION FOR REGISTERING A PROPOSED CITIZENS’ INITIATIVE The following information shall be provided in order to register a proposed citizens’ initiative on the Commission’s online register: 1. The title of the proposed citizens’ initiative, in no more than 100 characters; 2. The subject matter, in no more than 200 characters; 3. A description of the objectives of the proposed citizens’ initiative on which the Commission is invited to act, in no more than 500 characters; 4. The provisions of the Treaties considered relevant by the organisers for the proposed action; 5. The full names, postal addresses, nationalities and dates of birth of the seven members of the citizens’ committee, indicating specifically the representative and the substitute as well as their e-mail addresses (1); 6. All sources of support and funding for the proposed citizens’ initiative at the time of registration (1). Organisers may provide more detailed information on the subject, objectives and background to the proposed citizens’ initiative in an annex. They may also, if they wish, submit a draft legal act. (1) Privacy statement: in accordance with Article 11 of Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data, data subjects are informed that these personal data are compiled by the Commission for the purpose of the procedure in respect of the proposed citizens’ initiative. Only the full names of the organisers, the e-mail addresses of the contact persons and information relating to the sources of support and funding will be made available to the public on the Commission’s online register. Data subjects are entitled to object to the publication of their personal data on compelling legitimate grounds relating to their particular situation, and to request the rectification of that data at any time and its removal from the Commission’s online register after the expiry of a period of two years from the date of registration of the proposed citizens’ initiative. ANNEX III PART C 1. List of Member States which do not require the provision of a personal identification number/personal identification document number (statement of support form — Part A): Member State Signatories whose statement of support is to be submitted to the Member State concerned Belgium — residents in Belgium — Belgian nationals residing outside the country if they have informed their national authorities of their place of residence Denmark — residents in Denmark — Danish nationals residing outside the country if they have informed their national authorities of their place of residence Germany — residents in Germany — German nationals residing outside the country if they have informed their national authorities of their place of residence Estonia — residents in Estonia — Estonian nationals residing outside the country Ireland — residents in Ireland Netherlands — residents in the Netherlands Slovakia — residents in Slovakia — Slovak nationals residing outside the country Finland — residents in Finland — Finnish nationals residing outside the country United Kingdom — residents in the United Kingdom 2. List of Member States which require the provision of one of the personal identification numbers/personal identification document numbers, as specified below, in the statement of support form — Part B: BULGARIA — Единен граждански номер (personal number) CZECH REPUBLIC — Občanský průkaz (national identity card) — Cestovní pas (passport) GREECE — Δελτίο Αστυνομικής Ταυτότητας (identity card) — Διαβατήριο (passport) — Βεβαίωση Εγγραφής Πολιτών Ε.Ε./Έγγραφο πιστοποίησης μόνιμης διαμονής πολίτη Ε.Ε. (residence certificate/permanent residence certificate) SPAIN — Documento Nacional de Identidad (identity card) — Pasaporte (passport) FRANCE — Passeport (passport) — Carte nationale d’identité (national identity card) — Titre de séjour (residence permit) — Permis de conduire (driving licence) — Autre (other): — Carte d’identité de parlementaire avec photographie, délivrée par le président d’une assemblée parlementaire (parliamentarian’s identity card with photo, issued by the president of a parliamentary assembly), — Carte d’identité d’élu local avec photographie, délivrée par le représentant de l’Etat (elected local official’s identity card with photo, issued by the State representative), — Carte du combattant de couleur chamois ou tricolore (war veteran’s card, buff-coloured or tricoloured), — Carte d’invalidité civile ou militaire avec photographie (civilian or military invalidity card with photo), — Carte d’identité de fonctionnaire de l’Etat avec photographie (State civil servant’s identity card with photo), — Carte d’identité ou carte de circulation avec photographie, délivrée par les autorités militaires (identity card or free movement permit with photo, issued by the military authorities), — Permis de chasser avec photographie, délivré par le représentant de l’Etat (hunting permit with photo, issued by the State representative), — Livret ou carnet de circulation, délivré par le préfet en application de la loi no 69-3 du 3 janvier 1969 (traveller’s movement permit, issued by the Prefect pursuant to Law No 69-3 of 3 January 1969), — Récépissé valant justification de l’identité, délivré en échange des pièces d’identité en cas de contrôle judiciaire, en application du neuvième alinéa (7o) de l’article 138 du code de procédure pénale (receipt counting as proof of identity, issued in exchange for identity documentation in cases of judicial supervision pursuant to the ninth paragraph (numbered paragraph 7) of Article 138 of the Code of Criminal Procedure), — Attestation de dépôt d’une demande de carte nationale d’identité ou de passeport, délivrée depuis moins de trois mois par une commune et comportant une photographie d’identité du demandeur authentifiée par un cachet de la commune (certificate of lodgement of an application for a national identity card or passport, issued not more than three months previously by a municipality and bearing a photo of the applicant authenticated by a municipal stamp). ITALY — Passaporto (passport), inclusa l’indicazione dell’autorità di rilascio (including issuing authority) — Carta di identità (identity card), inclusa l’indicazione dell’autorità di rilascio (including issuing authority) CYPRUS — Δελτίο Ταυτότητας (identity card of national or resident) — Διαβατήριο (passport) LATVIA — Personas kods (personal identification number) LITHUANIA — Asmens kodas (personal number) LUXEMBOURG — Numéro d’identification national (numéro inscrit sur la carte d’identification de la Sécurité sociale) (national identification number appearing on the social security identity card) HUNGARY — személyazonosító igazolvány (identity card) — útlevél (passport) — személyi azonosító szám (személyi szám) (personal identification number) MALTA — Karta tal-Identità (identity card) AUSTRIA — Reisepass (passport) — Personalausweis (identity card) POLAND — Numer ewidencyjny PESEL (PESEL identification number) PORTUGAL — Bilhete de identidade (identity card) — Passaporte (passport) — Cartão de Cidadão (citizen’s card) ROMANIA — carte de identitate (identity card) — pasaport (passport) — certificat de inregistrare (registration certificate) — cartea de rezidenta permanenta pentru cetatenii UE (permanent residence card for EU citizens) — Cod Numeric Personal (personal identification number) SLOVENIA — Osebna izkaznica (identity card) — Potni list (passport) SWEDEN — Personnummer (personal identification number) in identity card — Personnummer (personal identification number) in passport ANNEX IV CERTIFICATE CONFIRMING THE CONFORMITY OF AN ONLINE COLLECTION SYSTEM WITH REGULATION (EU) No 211/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 16 FEBRUARY 2011 ON THE CITIZENS’ INITIATIVE … (name of competent authority) of … (name of Member State) hereby certifies that the online collection system … (website address) used for the collection of statements of support for … (title of proposed citizens’ initiative) complies with the relevant provisions of Regulation (EU) No 211/2011. Date, signature and official stamp of the competent authority: ANNEX V FORM FOR THE SUBMISSION OF STATEMENTS OF SUPPORT TO THE MEMBER STATES’ COMPETENT AUTHORITIES 1. Full names, postal addresses and e-mail addresses of the contact persons: 2. Title of proposed citizens’ initiative: 3. Commission registration number: 4. Date of registration: 5. Number of signatories coming from (name of Member State): 6. Annexes: (Include all statements of support from signatories to be verified by the relevant Member State. If applicable, include the relevant certificate(s) of conformity of the online collection system with Regulation (EU) No 211/2011 of the European Parliament and of the Council of 16 February 2011 on the citizens’ initiative.) 7. Date and signature of the contact persons: ANNEX VI CERTIFICATE CONFIRMING THE NUMBER OF VALID STATEMENTS OF SUPPORT COLLECTED FOR … (NAME OF MEMBER STATE) … (name of competent authority) of … (name of Member State), having made the necessary verifications required by Article 8 of Regulation (EU) No 211/2011 of the European Parliament and of the Council of 16 February 2011 on the citizens’ initiative, hereby certifies that … statements of support for the proposed citizens’ initiative having the registration number … are valid in accordance with the provisions of that Regulation. Date, signature and official stamp of the competent authority: ANNEX VII FORM FOR THE SUBMISSION OF A CITIZENS’ INITIATIVE TO THE COMMISSION 1. Title of citizens’ initiative: 2. Commission registration number: 3. Date of registration: 4. Number of valid statements of support received (must be at least one million): 5. Number of signatories certified by Member States: BE BG CZ DK DE EE IE EL ES FR IT CY LV LT LU Number of signatories HU MT NL AT PL PT RO SI SK FI SE UK TOTAL Number of signatories 6. Full names, postal addresses and e-mail addresses of the contact persons (1). 7. Indicate all sources of support and funding received for the initiative, including the amount of financial support at the time of submission (1): 8. We hereby declare that the information provided in this form is correct. Date and signature of the contact persons: 9. Annexes: (Include all certificates) (1) Privacy statement: in accordance with Article 11 of Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data, data subjects are informed that these personal data are compiled by the Commission for the purpose of the procedure in respect of the citizens’ initiative. Only the full names of the organisers, the e-mail addresses of the contact persons and information relating to the sources of support and funding will be made available to the public on the Commission’s online register. Data subjects are entitled to object to the publication of their personal data on compelling legitimate grounds relating to their particular situation, and to request the rectification of that data at any time and its removal from the Commission’s online register after the expiry of a period of two years from the date of registration of the proposed citizens’ initiative.

The citizens’ initiative The citizens’ initiative European Union citizens have the right of initiative under which they may invite the European Commission to propose a legal act in any field within its competence. It is the first example of transnational participatory democracy. ACT Regulation (EU) No 211/2011 of the European Parliament and of the Council of 16 February 2011 on the citizens’ initiative. SUMMARY WHAT DOES THIS REGULATION DO? The Regulation establishes the rules and procedures governing the citizens’ initiative. KEY POINTS To ensure that support is sufficiently broad, a citizens’ initiative must be supported by 1 million citizens from at least a quarter of EU countries, which currently means seven countries. There is also a requirement for a minimum number of signatories from each of these countries, roughly proportionate to their respective populations (degressive proportionality). Organising a citizens’ initiative To launch an initiative, citizens must form a ‘citizens' committee’ comprising at least seven members residing in at least seven EU countries. All must be old enough to vote in European Parliament elections. The initiative must be registered on the European Commission's website. If the registration criteria set out in the regulation are fulfilled, the registration is confirmed by the Commission and the organisers have 1 year to collect signatures (statements of support). Signing a citizens’ initiative The same voting age requirement applies to those signing the statements of support. These statements can be completed either on paper or online if organisers have set up an online collection system. One million signatures. What’s next? The Commission has 3 months to examine the initiative. During this time, the Commission meets with the organisers who also have the opportunity to present the initiative at a public hearing in the European Parliament. The Commission presents a formal response explaining what it intends to do and the reasons for that decision. It is not obliged to propose legislation. WHEN DOES THIS REGULATION APPLY? This regulation applies from 1 April 2012. Further information is available from the European Commission’s European Citizens’ Initiative website. REFERENCES Act Entry into force Entry into application Official Journal Regulation (EU) No 211/2011 31.3.2011 1.4.2012 OJ L 65, 11.3.2011, pp. 1-22 RELATED ACTS Commission Delegated Regulation (EU) No 268/2012 of 25 January 2012 amending Annex I of Regulation (EU) No 211/2011 of the European Parliament and of the Council on the citizens’ initiative (OJ L 89, 27.3.2012, pp. 1-2). Commission Delegated Regulation (EU) No 887/2013 of 11 July 2013 replacing Annexes II and III to Regulation (EU) No 211/2011 of the European Parliament and of the Council on the citizens’ initiative (OJ L 247, 18.9.2013, pp. 11-19). Communication from the Commission on the European Citizens' Initiative: ‘Water and sanitation are a human right! Water is a public good, not a commodity!’ (COM(2014) 177 final, 19.3.2014). Commission Delegated Regulation (EU) No 531/2014 of 12 March 2014 amending Annex I of Regulation (EU) No 211/2011 of the European Parliament and of the Council on the citizens’ initiative (OJ L 148, 20.5.2014, pp. 52-53). Corrigendum to Commission Delegated Regulation (EU) No 887/2013 of 11 July 2013 replacing Annexes II and III to Regulation (EU) No 211/2011 of the European Parliament and of the Council on the citizens’ initiative (OJ L 235, 8.8.2014, pp. 19-19). Commission Delegated Regulation (EU) 2015/1070 of 31 March 2015 amending Annexes III, V and VII of Regulation (EC) No 211/2011 of the European Parliament and of the Council on the citizens’ initiative (OJ L 178, 8.7.2015, pp. 1-11). Communication from the Commission on the European Citizens' Initiative: ‘One of us’ (COM(2014) 355 final, 28.5.2014). last update 08.07.2015

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27.3.2015 EN Official Journal of the European Union L 83/6 REGULATION (EU) 2015/476 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2015 on the measures that the Union may take following a report adopted by the WTO Dispute Settlement Body concerning anti-dumping and anti-subsidy matters (codification) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Council Regulation (EC) No 1515/2001 (3) has been substantially amended (4). In the interests of clarity and rationality, that Regulation should be codified. (2) By Council Regulation (EC) No 1225/2009 (5), common rules were laid down for protection against dumped imports from countries which are not members of the European Union. (3) By Council Regulation (EC) No 597/2009 (6), common rules were laid down for protection against subsidised imports from countries which are not members of the European Union. (4) Under the Marrakesh Agreement establishing the World Trade Organisation (‘WTO’), an Understanding on Rules and Procedures Governing the Settlement of Disputes (‘DSU’) was reached. Pursuant to the DSU, the Dispute Settlement Body (‘DSB’) was established. (5) With a view to permitting the Union, where it considers this appropriate, to bring a measure taken under Regulation (EC) No 1225/2009 or Regulation (EC) No 597/2009 into conformity with the recommendations and rulings contained in a report adopted by the DSB, specific provisions should be laid down. (6) The Commission may consider it appropriate to repeal, amend or adopt any other special measures with respect to measures taken under Regulation (EC) No 1225/2009 or Regulation (EC) No 597/2009, including measures which have not been the subject of dispute settlement under the DSU, in order to take account of the legal interpretations made in a report adopted by the DSB. In addition, the Commission should be able, where appropriate, to suspend or review such measures. (7) Recourse to the DSU is not subject to time limits. The recommendations in reports adopted by the DSB only have prospective effect. Consequently, it is appropriate to specify that any measures taken under this Regulation will take effect from the date of their entry into force, unless otherwise specified, and, therefore, do not provide any basis for the reimbursement of the duties collected prior to that date. (8) The implementation of this Regulation requires uniform conditions for adopting measures following a report adopted by the DSB concerning anti-dumping and anti-subsidy matters. Those measures should be adopted in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (7). (9) The advisory procedure should be used for the suspension of measures for a limited period of time given the effects of such measures, HAVE ADOPTED THIS REGULATION: Article 1 1. Whenever the DSB adopts a report concerning a Union measure taken pursuant to Regulation (EC) No 1225/2009, to Regulation (EC) No 597/2009 or to this Regulation (‘disputed measure’), the Commission may take one or more of the following measures, whichever it considers appropriate, in accordance with the examination procedure referred to in Article 4(3): (a) repeal or amend the disputed measure; or (b) adopt any other special implementing measure deemed to be appropriate in the circumstances in order to bring the Union into conformity with the recommendations and rulings contained in the report. 2. For the purpose of taking a measure under paragraph 1, the Commission may request interested parties to provide all necessary information in order to complete the information obtained during the investigation that resulted in the adoption of the disputed measure. 3. Insofar as it is appropriate to conduct a review before or at the same time as taking any measure under paragraph 1, that review shall be initiated by the Commission. The Commission shall provide information to the Member States once it decides to initiate a review. 4. Insofar as it is appropriate to suspend the disputed or amended measure, such suspension shall be granted for a limited period of time by the Commission, acting in accordance with the advisory procedure referred to in Article 4(2). Article 2 1. The Commission may also take any of the measures mentioned in Article 1(1) in order to take into account the legal interpretations made in a report adopted by the DSB with regard to a non-disputed measure, if it considers this appropriate. 2. For the purpose of taking a measure under paragraph 1, the Commission may request interested parties to provide all necessary information in order to complete the information obtained during the investigation that resulted in the adoption of the non-disputed measure. 3. Insofar as it is appropriate to conduct a review before or at the same time as taking any measure under paragraph 1, that review shall be initiated by the Commission. The Commission shall provide information to the Member States once it decides to initiate a review. 4. Insofar as it is appropriate to suspend the non-disputed or amended measure, that suspension shall be granted for a limited period of time by the Commission, acting in accordance with the advisory procedure referred to in Article 4(2). Article 3 Any measures adopted pursuant to this Regulation shall take effect from the date of their entry into force and shall not serve as a basis for the reimbursement of the duties collected prior to that date, unless otherwise provided for. Article 4 1. The Commission shall be assisted by the Committee established by Article 15(1) of Regulation (EC) No 1225/2009. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 5 The Commission shall include information on the implementation of this Regulation in its annual report on the application and implementation of trade defence measures presented to the European Parliament and to the Council pursuant to Article 22a of Regulation (EC) No 1225/2009. Article 6 Regulation (EC) No 1515/2001 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II. Article 7 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 11 March 2015. For the European Parliament The President M. SCHULZ For the Council The President Z. KALNIŅA-LUKAŠEVICA (1) Opinion of 10 December 2014 (not yet published in the Official Journal). (2) Position of the European Parliament of 11 February 2015 (not yet published in the Official Journal) and decision of the Council of 2 March 2015. (3) Council Regulation (EC) No 1515/2001 of 23 July 2001 on the measures that may be taken by the Community following a report adopted by the WTO Dispute Settlement Body concerning anti-dumping and anti-subsidy matters (OJ L 201, 26.7.2001, p. 10). (4) See Annex I. (5) Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (OJ L 343, 22.12.2009, p. 51). (6) Council Regulation (EC) No 597/2009 of 11 June 2009 on protection against subsidised imports from countries not members of the European Community (OJ L 188, 18.7.2009, p. 93). (7) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). ANNEX I Repealed Regulation with the amendment thereto Council Regulation (EC) No 1515/2001 (OJ L 201, 26.7.2001, p. 10). Regulation (EU) No 37/2014 of the European Parliament and of the Council (OJ L 18, 21.1.2014, p. 1). Only point 7 of the Annex ANNEX II Correlation Table Regulation (EC) No 1515/2001 This Regulation Articles 1, 2 and 3 Articles 1, 2 and 3 Article 3a Article 4 Article 3b Article 5 — Article 6 Article 4 Article 7 — Annex I — Annex II

Adapting EU trade defence measures following a WTO ruling Adapting EU trade defence measures following a WTO ruling SUMMARY OF: Regulation (EU) 2015/476 on the measures that the EU may take following a report adopted by the WTO Dispute Settlement Body concerning anti-dumping and anti-subsidy matters WHAT IS THE AIM OF THE REGULATION? It repeals Regulation (EC) No 1515/2001 on the measures that may be taken by the European Union (EU) following a report adopted by the World Trade Organization (WTO) Dispute Settlement Body (DSB) concerning anti-dumping and anti-subsidy matters. It permits the EU, where appropriate, to bring a measure taken under Regulation (EC) No 1225/2009 (anti-dumping measures*) or Regulation (EC) No 597/2009 (anti-subsidy measures*) into line with a report by the WTO’s DSB. KEY POINTS Specifically, the European Commission may: repeal or amend the disputed measure, or adopt any other special implementing measure deemed to be appropriate in the circumstances in order to comply with the WTO report, where appropriate, suspend or review such measures. Measures adopted under this regulation generally take effect from the date of their entry into force. FROM WHEN DOES THIS REGULATION APPLY? It has applied since 16 April 2015. BACKGROUND Where the government of a WTO member believes that another WTO member is violating an agreement or a commitment it has made in the WTO, the dispute is referred to the WTO’s DSB. * KEY TERMS Anti-dumping measures: measures, e.g. specific duties, applied to imports into the EU of ‘dumped products’, i.e. products exported to the EU at a lower price than the domestic price. Anti-subsidy measures: measures, e.g. countervailing duties (that neutralise the negative effects of subsidies), imposed by the EU on imports that are subsidised and thus injure EU industry producing the same product. MAIN DOCUMENT Regulation (EU) 2015/476 of the European Parliament and of the Council of 11 March 2015 on the measures that the Union may take following a report adopted by the WTO Dispute Settlement Body concerning anti-dumping and anti-subsidy matters (OJ L 83, 27.3.2015, pp. 6-10) last update 13.02.2017

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19.1.2013 EN Official Journal of the European Union L 17/13 REGULATION (EU) No 20/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 January 2013 implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) On 23 April 2007 the Council authorised the Commission to open negotiations with certain countries of Central America (‘Central America’) for an Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (‘the Agreement’) on behalf of the Union and its Member States. (2) Those negotiations have been concluded and the Agreement was signed on 29 June 2012, received the consent of the European Parliament on 11 December 2012 and is to apply as provided for in Article 353 of the Agreement. (3) It is necessary to lay down the most appropriate procedures to guarantee the effective application of certain provisions of the Agreement which concern the bilateral safeguard clause and for applying the stabilisation mechanism for bananas that has been agreed with Central America. (4) It is also necessary to create appropriate safeguard mechanisms to prevent serious harm to the Union banana growing sector which is of great importance to the agricultural producers of many of the outermost regions of the Union. The limited ability of those regions to diversify, owing to their natural characteristics, makes the banana sector particularly vulnerable. It is therefore essential to create effective mechanisms to address preferential imports from third countries concerned, in order to guarantee that Union banana production is maintained under the best possible conditions, as it is a crucial employment sector in certain areas, especially in the outermost regions. (5) The terms ‘serious injury’, ‘threat of serious injury’ and ‘transition period’ as referred to in Articles 104 and 105 of the Agreement should be defined. (6) Safeguard measures should be considered only if the product in question is imported into the Union in such increased quantities, in absolute terms or relative to Union production, and under such conditions as to cause, or threaten to cause, serious injury to Union producers of like or directly competitive products as laid down in Article 104 of the Agreement. (7) Specific safeguard provisions should be available in case the product in question is imported in such increased quantities and under such conditions as to cause or threaten to cause serious deterioration in the economic situation of any of the outermost regions as referred to in Article 349 of the Treaty on the Functioning of the European Union (TFEU). (8) Safeguard measures should take one of the forms referred to in Article 104(2) of the Agreement. (9) The tasks of following up and reviewing the Agreement, carrying out investigations and, if necessary, imposing safeguard measures should be carried out in the most transparent manner possible. (10) The Commission should submit an annual report to the European Parliament and to the Council on the implementation of the Agreement and the application of the safeguard measures and the stabilisation mechanism for bananas. (11) The challenges in Central America as regards human, social, labour and environmental rights in connection with products from that region require a close dialogue between the Commission and Union civil society organisations. (12) The importance of complying with the international labour standards drawn up and supervised by the International Labour Organisation should be stressed. (13) The Commission should monitor the observance by Central America of the social and environmental standards laid down in Title VIII of Part IV of the Agreement. (14) There should be detailed provisions on the initiation of proceedings. The Commission should receive information including available evidence from the Member States of any trends in imports which might call for the application of safeguard measures. (15) The reliability of statistics on all imports from Central America to the Union is therefore crucial to determining whether the conditions to apply safeguard measures are met. (16) In some cases, an increase of imports concentrated in one or several of the Union's outermost regions or Member States may cause, or threaten to cause, serious deterioration or serious injury in their economic situation. In the event that there is an increase of imports concentrated in one or several of the Union's outermost regions or Member States, the Commission should be able to introduce prior surveillance measures. (17) If there is sufficient prima facie evidence to justify the initiation of a proceeding, the Commission should publish a notice as provided for in Article 111(3) of the Agreement in the Official Journal of the European Union. (18) There should be detailed provisions on the initiation of investigations, access to and inspections by interested parties of the information gathered, hearings for the interested parties involved and the opportunities for those parties to submit their views as provided for in Article 111(3) of the Agreement. (19) The Commission should notify Central America in writing of the initiation of an investigation and notify the results of the investigations to the Association Committee as provided for in Article 116 of the Agreement. (20) It is also necessary, pursuant to Article 112 of the Agreement, to set time limits for the initiation of an investigation and for determinations as to whether or not safeguard measures are appropriate, with a view to ensuring that such determinations are made quickly, in order to increase legal certainty for the economic operators concerned. (21) An investigation should precede the application of any safeguard measure, subject to the Commission being allowed to apply provisional safeguard measures in critical circumstances as referred to in Article 106 of the Agreement. (22) Close monitoring should facilitate a timely decision concerning the possible initiation of an investigation or imposition of measures. Therefore the Commission should regularly monitor imports of bananas from the date of application of the Agreement. Monitoring should be extended to other sectors upon a duly justified request. (23) There should be a possibility to suspend swiftly for a maximum period of three months the preferential customs duties when imports exceed a defined annual trigger import volume. The decision whether or not to apply the stabilisation mechanism for bananas should take into account the stability of the Union market for bananas. (24) Safeguard measures should be applied only to the extent, and for such time, as may be necessary to prevent serious injury and to facilitate adjustment. The maximum duration of safeguard measures should be determined and specific provisions regarding extension and review of such measures should be laid down, as referred to in Article 105 of the Agreement. (25) The Commission should enter into consultations with the Central American country affected by measures. (26) The implementation of the bilateral safeguard clause and the stabilisation mechanism for bananas provided for in the Agreement requires uniform conditions for the adoption of provisional and definitive safeguard measures, for the imposition of prior surveillance measures, for the termination of an investigation without measures and for suspending temporarily the preferential customs duty established under the stabilisation mechanism for bananas that has been agreed with Central America. In order to ensure uniform conditions for the implementation of this Regulation, those measures should be adopted by the Commission in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (2). (27) The advisory procedure should be used for the adoption of surveillance and provisional safeguard measures given the effects of those measures and their sequential logic in relation to the adoption of definitive safeguard measures. Where a delay in the imposition of provisional safeguard measures would cause damage which would be difficult to repair, the Commission should adopt immediately applicable implementing acts. (28) Given the nature and the relatively short duration of the measures foreseen under the stabilisation mechanism for bananas, and in order to prevent a negative impact on the situation of the Union market for bananas, the Commission should also adopt immediately applicable implementing acts for the temporary suspension of the preferential customs duty established under the stabilisation mechanism for bananas, or to determine that such temporary suspension is not appropriate. Where such immediately applicable implementing acts are applied, the advisory procedure should be used. (29) The Commission should make diligent and effective use of the stabilisation mechanism for bananas in order to avoid a threat of serious deterioration or a serious deterioration for producers in the outermost regions in the Union. From 1 January 2020, the general bilateral safeguard mechanism, including the special provisions for outermost regions, remains applicable. (30) For purposes of adopting the necessary implementing rules for the application of the rules contained in Appendix 2A of Annex II (Concerning the definition of the concept of ‧originating products‧ and methods of administrative co-operation) and Appendix 2 of Annex I (Elimination of Customs Duties) to the Agreement, Article 247a of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (3) should be applied. (31) This Regulation should apply only to products originating in the Union or in Central America, HAVE ADOPTED THIS REGULATION: CHAPTER I SAFEGUARD PROVISIONS Article 1 Definitions For the purposes of this Regulation: (a) ‘product’ means a good originating in the Union or in a Central American country. A product subject to an investigation may cover one or several tariff lines or a sub-segment thereof depending on the specific market circumstances, or any product segmentation commonly applied in the Union industry; (b) ‘interested parties’ means parties affected by the imports of the product in question; (c) ‘Union industry’ means the Union producers as a whole of the like or directly competitive products, operating within the territory of the Union, Union producers whose collective output of the like or directly competitive products constitutes a major proportion of the total Union production of those products, or, where a like or a directly competitive product is only one of several products that are made by the Union producers, the specific operations that are involved in the production of the like or directly competitive product; (d) ‘serious injury’ means a significant overall impairment; (e) ‘threat of serious injury’ means serious injury that is clearly imminent; (f) ‘serious deterioration’ means significant disturbances in a sector or in Union industry; (g) ‘threat of serious deterioration’ means significant disturbances that are clearly imminent; (h) ‘transitional period’ means ten years from the date of application of the Agreement, for a product for which the Schedule of the EU Party, as set out in Annex I (Elimination of Customs Duties) to the Agreement (‘Tariff Elimination Schedule’) provides for a tariff elimination period of less than ten years, or the tariff elimination period plus three years for a product for which the Tariff Elimination Schedule provides for a tariff elimination period of ten or more years; (i) ‘Central American country’ means Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua or Panama. A determination of the existence of a threat of serious injury within the meaning of point (e) of the first paragraph shall be based on verifiable facts and not merely on an allegation, a conjecture or a remote possibility. In order to determine the existence of a threat of serious injury, forecasts, estimations and analyses made on the basis of factors referred to in Article 5(5), shall, inter alia, be taken into account. Article 2 Principles 1. A safeguard measure may be imposed in accordance with this Regulation where a product originating in a Central American country is, as a result of the reduction or the elimination of the customs duties on that product, imported into the Union in such increased quantities, in absolute terms or relative to Union production, and under such conditions as to cause or threaten to cause serious injury to the Union industry. 2. A safeguard measure may take one of the following forms: (a) a suspension of a further reduction of the rate of customs duty on the product concerned provided for in the Tariff Elimination Schedule; (b) an increase in the rate of customs duty on the product concerned to a level which does not exceed the lesser of: — the most-favoured-nation (‘MFN’) applied rate of customs duty on the product in effect at the time the measure is taken; or — the MFN applied rate of customs duty on the product in effect on the day immediately preceding the date of entry into force of the Agreement. 3. A safeguard measure shall not be applied within the limits of the preferential duty free tariff quotas granted by the Agreement. Article 3 Monitoring 1. The Commission shall monitor the evolution of import statistics of bananas from Central American countries. For that purpose, it shall cooperate and exchange data on a regular basis with Member States and the Union industry. 2. Upon a duly justified request by the industries concerned, the Commission may consider extending the scope of the monitoring to other sectors. 3. The Commission shall present an annual monitoring report to the European Parliament and to the Council on updated statistics on imports from Central American countries of bananas and those sectors to which monitoring has been extended. 4. The Commission shall monitor the observance by Central American countries of the social and environmental standards laid down in Title VIII of Part IV of the Agreement. Article 4 Initiation of proceedings 1. A proceeding shall be initiated upon request by a Member State, by any legal person or any association not having legal personality acting on behalf of the Union industry, or on the Commission's own initiative if it is apparent to the Commission that there is sufficient prima facie evidence, as determined on the basis of factors referred to in Article 5(5), to justify such initiation. 2. The request to initiate a proceeding shall contain evidence that the conditions for imposing the safeguard measure set out in Article 2(1) are met. The request shall generally contain the following information: the rate and amount of the increase in imports of the product concerned in absolute and relative terms, the share of the domestic market taken by increased imports and changes in the level of sales, production, productivity, capacity utilisation, profits and losses, and employment. 3. A proceeding may also be initiated in the event that there is a surge of imports concentrated in one or several Member States, or outermost regions, provided that there is sufficient prima facie evidence that the conditions for initiation are met, in accordance with Article 5(5). 4. A Member State shall inform the Commission if trends in imports from a Central American country appear to call for safeguard measures. That information shall include the evidence available in accordance with Article 5(5). 5. The Commission shall provide that information to the Member States when it receives a request to initiate a proceeding or when it considers initiation of a proceeding to be appropriate on its own initiative pursuant to paragraph 1. 6. Where it is apparent that there is sufficient prima facie evidence in accordance with Article 5(5) to justify the initiation of a proceeding the Commission shall initiate proceedings and shall publish a notice thereof in the Official Journal of the European Union. Initiation shall take place within one month of receipt by the Commission of the request or information pursuant to paragraph 1. 7. The notice referred to in paragraph 6 shall: (a) give a summary of the information received, and require that all relevant information be communicated to the Commission; (b) state the period within which interested parties may make known their views in writing and submit information, if such views and information are to be taken into account during the proceeding; (c) state the period within which interested parties may apply to be heard orally by the Commission in accordance with Article 5(9). Article 5 Investigations 1. Following the initiation of the proceeding, the Commission shall commence an investigation. The period as set out in paragraph 3 shall start on the day the decision to initiate the investigation is published in the Official Journal of the European Union. 2. The Commission may request Member States to supply information and Member States shall take whatever steps are necessary in order to give effect to any such request. If that information is of general interest and is not confidential within the meaning of Article 12, it shall be added to the non-confidential files as provided for in paragraph 8 of this Article. 3. The investigation shall, where possible, be concluded within six months of its initiation. That time limit may be extended by a further period of three months in exceptional circumstances such as the involvement of an unusually high number of interested parties or complex market situations. The Commission shall notify all interested parties of any such extension and explain the reasons therefor. 4. The Commission shall seek all information it considers necessary to make a determination with regard to the conditions set out in Article 2(1), and, shall, where appropriate, endeavour to verify that information. 5. In the investigation the Commission shall evaluate all relevant factors of an objective and quantifiable nature having a bearing on the situation of the Union industry, in particular, the rate and amount of the increase in imports of the product concerned in absolute and relative terms, the share of the domestic market taken by increased imports and changes in the level of sales, production, productivity, capacity utilisation, profits and losses, and employment. This list is not exhaustive and other relevant factors may also be taken into consideration by the Commission for its determination of the existence of serious injury or threat of serious injury, such as stocks, prices, return on capital employed, cash flow, and other factors which are causing or may have caused serious injury, or threaten to cause serious injury to the Union industry. 6. Interested parties who have submitted information pursuant to Article 4(7)(b) and representatives of the Central American country concerned may, upon written request, inspect all information made available to the Commission in connection with the investigation other than internal documents prepared by the Union authorities or those of the Member States, provided that that information is relevant to the presentation of their case and not confidential within the meaning of Article 12 and that it is used by the Commission in the investigation. Interested parties who have submitted information may communicate their views on the information to the Commission. Where there is sufficient prima facie evidence in support of those views, the Commission shall take them into consideration. 7. The Commission shall ensure that all data and statistics which are used for the investigation are available, comprehensible, transparent and verifiable. 8. The Commission shall, as soon as the necessary technical framework is in place, ensure password-protected online access to the non-confidential file, which it shall manage and through which all information which is relevant and is not confidential within the meaning of Article 12 shall be disseminated. Interested parties, Member States and the European Parliament shall be granted access to that online platform. 9. The Commission shall hear interested parties, in particular where they have made a written application within the period laid down in the notice published in the Official Journal of the European Union, showing that they are actually likely to be affected by the outcome of the investigation and that there are special reasons for them to be heard orally. The Commission shall hear interested parties on further occasions if there are special reasons therefor. 10. Where information is not supplied within the time limits set by the Commission, or where the investigation is significantly impeded, the Commission may make findings on the basis of the facts available. Where the Commission finds that any interested party or any third party has supplied it with false or misleading information, it shall disregard that information and may make use of the facts available. 11. The Commission shall notify the Central American country concerned in writing of the initiation of an investigation. Article 6 Prior surveillance measures 1. The Commission may adopt prior surveillance measures in regard to imports from a Central American country where: (a) the trend in imports of a product is such that it could lead to one of the situations referred to in Articles 2 and 4; or (b) there is a surge of imports of bananas concentrated in one or several Member States, or in one or several of the Union's outermost regions. 2. The Commission shall adopt prior surveillance measures in accordance with the advisory procedure referred to in Article 14(2). 3. Prior surveillance measures shall have a limited period of validity. Unless otherwise provided, they shall cease to be valid at the end of the second six-month period following the first six months after their introduction. Article 7 Imposition of provisional safeguard measures 1. Provisional safeguard measures shall be applied in critical circumstances where a delay would cause damage which would be difficult to repair, pursuant to a preliminary determination on the basis of the factors referred to in Article 5(5) that there is sufficient prima facie evidence that imports of a product originating in a Central American country have increased as a result of the reduction or elimination of a customs duty in accordance with the Tariff Elimination Schedule, and such imports cause serious injury, or threat thereof, to the Union industry. The Commission shall adopt provisional safeguard measures in accordance with the advisory procedure referred to in Article 14(2). In cases of imperative grounds of urgency, including the case referred to in paragraph 2 of this Article, the Commission shall adopt immediately applicable provisional safeguard measures in accordance with the procedure referred to in Article 14(4). 2. Where a Member State requests immediate intervention by the Commission and where the conditions set out in paragraph 1 are met, the Commission shall take a decision within five working days of receiving the request. 3. Provisional safeguard measures shall not apply for more than 200 calendar days. 4. Should the provisional safeguard measures be repealed because the investigation shows that the conditions set out in Article 2(1) are not met, any customs duty collected as a result of those provisional safeguard measures shall be refunded automatically. 5. Provisional safeguard measures shall apply to every product which is put into free circulation after the date of entry into force of those measures. However, such measures shall not prevent the release for free circulation of products already on their way to the Union where the destination of such products cannot be changed. Article 8 Termination of investigations and proceedings without measures 1. Where the facts as finally established show that the conditions set out in Article 2(1) are not met, the Commission shall adopt a decision terminating the investigation and proceeding in accordance with the examination procedure referred to in Article 14(3). 2. The Commission shall make public, with due regard to the protection of confidential information within the meaning of Article 12, a report setting out its findings and reasoned conclusions reached on all pertinent issues of fact and law. Article 9 Imposition of definitive safeguard measures 1. Where the facts as finally established show that the conditions set out in Article 2(1) are met, the Commission shall refer the matter to the Association Committee for examination in accordance with Article 116 of the Agreement. Where no recommendation has been made by the Association Committee or no other satisfactory solution has been reached within 30 days of the referral, the Commission may adopt a decision imposing definitive safeguard measures in accordance with the examination procedure referred to in Article 14(3). 2. The Commission shall make public, with due regard to the protection of confidential information within the meaning of Article 12, a report containing a summary of the material facts and considerations relevant to the determination. Article 10 Duration and review of safeguard measures 1. A safeguard measure shall remain in force only for such period of time as may be necessary to prevent or remedy the serious injury to Union industry and to facilitate adjustment. That period shall not exceed two years, unless it is extended under paragraph 3. 2. A safeguard measure shall remain in force, pending the outcome of the review under paragraph 3, during any extension period. 3. The initial period of duration of a safeguard measure may exceptionally be extended by up to two years provided that the safeguard measure continues to be necessary to prevent or remedy serious injury to Union industry and that there is evidence that the Union industry is adjusting. 4. Any extension pursuant to paragraph 3 of this Article shall be preceded by an investigation upon a request by a Member State, by any legal person or any association not having legal personality acting on behalf of the Union industry, or on the Commission's own initiative if there is sufficient prima facie evidence that the conditions laid down in paragraph 3 of this Article are met, on the basis of factors referred to in Article 5(5). 5. The initiation of an investigation shall be published in accordance with Article 4(6) and (7). The investigation and any decision regarding an extension pursuant to paragraph 3 of this Article shall be made in accordance with Articles 5, 8 and 9. 6. The total duration of a safeguard measure shall not exceed four years, including any provisional safeguard measure. 7. A safeguard measure shall not be applied beyond the expiry of the transitional period, except with the consent of the Central American country concerned. 8. No safeguard measure shall be applied to the import of a product that has previously been subject to such a measure, unless a period of time equal to half of that during which the safeguard measure was applied for the immediately preceding period has elapsed. Article 11 Outermost regions of the Union Where any product originating in a Central American country is being imported in such increased quantities and under such conditions as to cause or threaten to cause serious deterioration in the economic situation of one or several of the Union's outermost regions, as referred to in Article 349 TFEU, a safeguard measure may be imposed, in accordance with this Chapter. Article 12 Confidentiality 1. Information received pursuant to this Regulation shall be used only for the purpose for which it was requested. 2. Neither information of a confidential nature nor any information provided on a confidential basis received pursuant to this Regulation shall be disclosed without the express consent of the supplier of such information. 3. Each request for confidentiality shall state the reasons why the information is confidential. However, if the supplier of the information requests that the information is not made public or disclosed, in full or in summary form, and if that request is unjustified, the information concerned may be disregarded. 4. Information shall in any case be considered to be confidential if its disclosure is likely to have a significantly adverse effect upon the supplier or the source of such information. 5. Paragraphs 1 to 4 shall not preclude reference by the Union authorities to general information and in particular to reasons on which decisions taken pursuant to this Regulation are based. Those authorities shall, however, take into account the legitimate interest of natural and legal persons concerned that their business secrets should not be divulged. Article 13 Report 1. The Commission shall submit an annual report to the European Parliament and to the Council on the application, implementation and fulfilment of obligations of Part IV of the Agreement and of this Regulation. 2. The report shall include information about the application of provisional and definitive measures, prior surveillance measures, regional surveillance and safeguard measures and the termination of investigations and proceedings without measures. 3. The report shall include information on the activities of the various bodies responsible for monitoring the implementation of the Agreement, including on fulfilment of obligations under Title VIII of Part IV of the Agreement and on activities with civil society advisory groups. 4. The report shall set out a summary of the statistics and the evolution of trade with Central American countries and shall include up-to-date statistics on banana imports from Central American countries. 5. The European Parliament may, within one month of submission of the Commission's report, invite the Commission to an ad hoc meeting of its responsible committee to present and explain any issues related to the implementation of this Regulation. 6. No later than three months after submitting its report to the European Parliament and to the Council, the Commission shall make it public. Article 14 Committee procedure 1. The Commission shall be assisted by the Committee established by Article 4(1) of Council Regulation (EC) No 260/2009 of 26 February 2009 on the common rules for imports (4) (‘the Committee’). The Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 thereof, shall apply. 5. The Committee may examine matters relating to the application of this Regulation, raised by the Commission or at the request of a Member State. Member States may request information and may exchange views in the Committee or directly with the Commission. CHAPTER II STABILISATION MECHANISM FOR BANANAS Article 15 Stabilisation mechanism for bananas 1. For bananas originating in Central America falling under heading 0803 00 19 of the Combined Nomenclature (fresh Bananas, excluding plantains) and listed under category ‘ST’ in the Tariff Elimination Schedule, a stabilisation mechanism shall apply until 31 December 2019. 2. A separate annual trigger import volume is set for imports of products referred to in paragraph 1, as indicated in the table in the Annex. The importation of the products referred to in paragraph 1 at the preferential customs duty rate shall, in addition to the proof of origin established under Annex II (Concerning the definition of the concept of ‘originating products’ and methods of administrative co-operation) to the Agreement, be subject to the presentation of an export certificate issued by the competent authority of the Republic of the Central American country from which the products are exported. Once the trigger volume for a Central American country is met during the corresponding calendar year, the Commission shall, in accordance with the urgency procedure referred to in Article 14(4), adopt an implementing act by which it may either temporarily suspend the preferential customs duty applied to products of the corresponding origin during that same year for a period of time not exceeding three months, and not going beyond the end of the calendar year or determine that such suspension is not appropriate. 3. When deciding whether measures should be applied pursuant to paragraph 2, the Commission shall take into consideration the impact of the imports concerned on the situation of the Union market for bananas. That examination shall include factors such as: effect of the imports concerned on the Union price level, development of imports from other sources, overall stability of the Union market. 4. Where the Commission decides to suspend the preferential customs duty applicable, it shall apply the lesser of the base rate of customs duty or the MFN rate of duty that in application at the time such action is taken. 5. Where the Commission applies the actions referred to in paragraphs 2 and 4, it shall immediately enter into consultations with the affected Central American country or countries to analyse and evaluate the situation on the basis of available factual data. 6. The application of the stabilisation mechanism for bananas set out in this Chapter is without prejudice to the application of any measures defined in Chapter I. Measures taken pursuant to the provisions of both chapters shall not, however, be applied simultaneously. 7. The measures referred to in paragraphs 2 and 4 shall be applicable only during the period ending on 31 December 2019. CHAPTER III IMPLEMENTING RULES Article 16 Implementing rules The applicable provision for the purposes of adopting the necessary implementing rules for the application of the rules contained in Appendix 2A of Annex II (Concerning the definition of the concept of ‘originating products’ and methods of administrative co-operation) and Appendix 2 of Annex I (Elimination of Customs Duties) to the Agreement shall be Article 247a of Regulation (EEC) No 2913/92. CHAPTER IV FINAL PROVISIONS Article 17 Entry into force This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. It shall apply from the date of application of the Agreement as provided for in Article 353 thereof. A notice shall be published in the Official Journal of the European Union specifying the date of application of the Agreement. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 15 January 2013. For the European Parliament The President M. SCHULZ For the Council The President L. CREIGHTON (1) Position of the European Parliament of 11 December 2012 (not yet published in the Official Journal) and decision of the Council of 20 December 2012. (2) OJ L 55, 28.2.2011, p. 13. (3) OJ L 302, 19.10.1992, p. 1. (4) OJ L 84, 31.3.2009, p. 1. ANNEX Table regarding trigger import volumes for the application of the stabilisation mechanism for bananas provided for in Appendix 3 of Annex I to the Agreement Year Trigger import volume, in tonnes Costa Rica Panama Honduras Guatemala Nicaragua El Salvador Until 31 December 2010 1 025 000 375 000 50 000 50 000 10 000 2 000 1.1-31.12.2011 1 076 250 393 750 52 500 52 500 10 500 2 100 1.1-31.12.2012 1 127 500 412 500 55 000 55 000 11 000 2 200 1.1-31.12.2013 1 178 750 431 250 57 500 57 500 11 500 2 300 1.1-31.12.2014 1 230 000 450 000 60 000 60 000 12 000 2 400 1.1-31.12.2015 1 281 250 468 750 62 500 62 500 12 500 2 500 1.1-31.12.2016 1 332 500 487 500 65 000 65 000 13 000 2 600 1.1-31.12.2017 1 383 750 506 250 67 500 67 500 13 500 2 700 1.1-31.12.2018 1 435 000 525 000 70 000 70 000 14 000 2 800 1.1-31.12.2019 1 486 250 543 750 72 500 72 500 14 500 2 900 1.1.2020 and after not applicable not applicable not applicable not applicable not applicable not applicable COMMISSION STATEMENT The Commission welcomes the first reading agreement between the European Parliament and the Council on Regulation (EU) No 20/2013 of the European Parliament and of the Council of 15 January 2013 implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (1). As envisaged in Regulation (EU) No 20/2013, the Commission will submit an annual report to the European Parliament and to the Council on the implementation of Part IV of the Agreement and will be ready to discuss with the responsible committee of the European Parliament any issues arising from the implementation of Part IV of the Agreement. The Commission will attach particular importance to the effective implementation of commitments on trade and sustainable development in the Agreement, taking into account the specific information provided by the relevant monitoring bodies of the fundamental Conventions of the International Labour Organisation and the multilateral environmental agreements listed in Title VIII of Part IV of the Agreement. In this context, the Commission will also seek the views of the relevant civil society advisory groups. After the expiry of the Banana Stabilisation Mechanism on 31 December 2019, the Commission will assess the situation of the Union market for bananas and the state of Union banana producers. The Commission will report its findings to the European Parliament and the Council and would include a preliminary assessment of the functioning of the ‘Programme d'Options Spécifiques à l'Éloignement et l'Insularité’ (POSEI) in preserving the banana production in the Union. (1) See page 13 of this Official Journal. JOINT DECLARATION The European Parliament and the Commission agree on the importance of close cooperation in monitoring the implementation of Part IV of the Agreement and Regulation (EU) No 20/2013 of the European Parliament and of the Council of 15 January 2013 implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (1). To that end they agree on the following: — Upon request by the responsible committee of the European Parliament, the Commission shall report to it on any specific concerns relating to the implementation by Central American countries of their commitments on trade and sustainable development. — If the European Parliament adopts a recommendation to initiate a safeguard investigation, the Commission will carefully examine whether the conditions under Regulation (EU) No 20/2013 for ex-officio initiation are fulfilled. If the Commission considers that the conditions are not fulfilled, it will present a report to the responsible committee of the European Parliament including an explanation of all the factors relevant to the initiation of such an investigation. (1) See page 13 of this Official Journal.

Association Agreement between the EU and Central America Association Agreement between the EU and Central America SUMMARY OF: Agreement establishing an Association between the EU and Central America Decision 2012/734/EU — signing, on behalf of the EU, the Agreement establishing an Association between the EU and Central America Decision No 5/2014 of the EU-Central America Association Council — on the geographical indications to be included in Annex XVIII of the Agreement Regulation (EU) No 20/2013 — implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Agreement establishing an Association between the EU and Central America WHAT IS THE AIM OF THE AGREEMENT, DECISIONS AND REGULATION? The aims of the agreement include to: strengthen and consolidate the relations between the parties through an association based on three interdependent and fundamental parts; develop a privileged political partnership based on values, principles and common objectives, in particular the respect for and the promotion of democracy and human rights, sustainable development, good governance and the rule of law; enhance bi-regional cooperation between the EU and Central America in all areas of common interest; expand and diversify the parties’ bi-regional trade relation in conformity with the World Trade Organisation (WTO) agreement and this agreement; strengthen and deepen regional integration in areas of common interest; reinforce good neighbourly relations and the principle of peaceful resolution of disputes; maintain and develop the level of good governance, social, labour and environmental standards; foster increased trade and investment among the parties. The Council decision concludes the agreement on behalf of the EU. Decision No 5/2014 establishes the geographical indications of products originating from the 2 parties. The regulation creates safeguard mechanisms to prevent serious harm to the EU banana-growing sector in the EU’s outermost regions. KEY POINTS The agreement consists of three strands: 1. Political dialogue The objectives of the political dialogue between the 2 parties are to: establish a privileged political partnership; defend common values, principles and objectives by promoting them at international level, in particular at the United Nations (UN); strengthen the UN as the core of the multilateral system, in order to enable it to tackle global challenges effectively; enable a broad exchange of views, positions and information leading to joint initiatives at international level; cooperate in the field of foreign and security policy, with the objective of coordinating their positions and taking joint initiatives of mutual interest in the relevant international forums. Such dialogue can cover all aspects of mutual interest at international or regional level, however, a number of specific issues are mentioned including: disarmament; the fight against terrorism; migration; the environment. 2. Cooperation The agreement gives priority to cooperation aimed at achieving the following objectives: strengthening peace and security; reinforcing democratic institutions, good governance and full applicability of the rule of law, gender equality, all forms of non-discrimination, cultural diversity, pluralism, promotion and respect for human rights, fundamental freedoms, transparency and citizen participation; contributing to social cohesion; promoting economic growth with a view to furthering sustainable development; deepening the process of regional integration in Central America; reinforcing production and management capacities and enhancing competitiveness. 3. Trade The objectives of this strand include: expanding and diversifying trade in goods; facilitating trade in goods; liberalising trade in services, in conformity with Article V of the General Agreement on Trade in Services (GATS); promoting economic regional integration in the area of customs procedures, technical regulations and sanitary and phytosanitary measures; developing a climate conducive to increased investment; the effective, reciprocal and gradual opening of government procurement markets; adequately and effectively protecting intellectual property rights; promoting free and undistorted competition in the economic and trade relations; establishing an effective, fair and predictable dispute-settlement mechanism; promoting international trade and investment between the parties. The agreement includes a number of measures to achieve these objectives, in particular it: provides substantially improved market access for EU exports to Central America through: eliminating tariffs on manufactured goods, fisheries and agriculture;addressing obstacles to trade in goods;improving market access to government procurement, services and investment; establishes a level playing field through common rules in areas such as: intellectual property and geographical indications;competition and state aid;dispute settlement; reinforces regional integration by introducing measures such as: a single administrative document for customs declarations;a single import duty for the region; sets out an agreement for sustainable development designed to: further economic development through trade;address the interrelation between trade and social and environmental policies;encourage and promote trade and marketing schemes based on sustainability criteria. WHEN DID THE AGREEMENT, DECISIONS AND REGULATION ENTER INTO FORCE? The trade part of the agreement has provisionally applied since: 1 August 2013 with Honduras, Nicaragua and Panama;1 October 2013 with Costa Rica and El Salvador; and1 December 2013 with Guatemala. The Council decision entered into force on 25 June 2012, the regulation on 22 January 2013 and Decision No 5/2014 on 5 August 2015. BACKGROUND For more information, see: Central America (European Commission). MAIN DOCUMENTS Council Decision 2012/734/EU of 25 June 2012 on the signing, on behalf of the European Union, of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other, and the provisional application of Part IV thereof concerning trade matters (OJ L 346, 15.12.2012, pp. 1-2) Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (OJ L 346, 15.12.2012, pp. 3-2621) Decision No 5/2014 of the EU-Central America Association Council of 7 November 2014 on the geographical indications to be included in Annex XVIII of the Agreement [2015/1219] (OJ L 196, 24.7.2015, pp. 59-66) Regulation (EU) No 20/2013 of the European Parliament and of the Council of 15 January 2013 implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (OJ L 17, 19.1.2013, pp. 13-24) Successive amendments to Regulation (EU) No 20/2013 have been incorporated into the original act. This consolidated version is of documentary value only. RELATED DOCUMENTS Notice concerning the provisional application of Part IV (trade matters) of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (Guatemala) (OJ L 315, 26.11.2013, p. 1) Notice concerning the provisional application of Part IV (trade matters) of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (Costa Rica) (OJ L 257, 28.9.2013, p. 1) Notice concerning the provisional application of Part IV (trade matters) of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (El Salvador) (OJ L 257, 28.9.2013, p. 1) Notice concerning the provisional application of Part IV (trade matters) of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (Nicaragua) (OJ L 204, 31.7.2013, p. 1) Notice concerning the provisional application of Part IV (trade matters) of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (Panama) (OJ L 204, 31.7.2013, p. 1) Notice concerning the provisional application of Part IV (trade matters) of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other (Honduras) (OJ L 204, 31.7.2013, p. 1) last update 02.10.2019

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20.3.2013 EN Official Journal of the European Union L 78/41 REGULATION (EU) No 229/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 March 2013 laying down specific measures for agriculture in favour of the smaller Aegean islands and repealing Council Regulation (EC) No 1405/2006 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular the first paragraph of Article 42 and Article 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Specific measures in the agricultural sector to remedy the difficulties caused by the particular geographical situation of the smaller Aegean islands have been established by Council Regulation (EC) No 1405/2006 (3). Those measures have been implemented by means of a support programme, which constitutes an essential tool for supplying those islands with agricultural products and for supporting local agricultural production. In view of the need to update the current measures, including as a result of the entry into force of the Treaty of Lisbon, it is necessary to repeal Regulation (EC) No 1405/2006 and replace it with a new regulation. (2) The fundamental objectives which the scheme promoting the smaller Aegean islands will help to achieve need to be specified. (3) It is also necessary to specify the content of the support programme for the smaller Aegean islands (‘support programme’), which, in accordance with the principle of subsidiarity, should be established by Greece at the most appropriate geographical level and submitted by Greece to the Commission for approval. (4) In order to more effectively achieve the objectives of the scheme promoting the smaller Aegean islands, the support programme should include measures which ensure the supply of agricultural products and the preservation and development of local agricultural production. The level of programming needs to be harmonised and the policy of partnership between the Commission and Greece needs to become systematic. The Commission should adopt procedures and indicators to ensure the smooth implementation and adequate monitoring of the programme. (5) In keeping with the principle of subsidiarity and in order to ensure flexibility, the two principles which form the basis of the programming approach adopted for the scheme promoting the smaller Aegean islands, the authorities appointed by Greece may propose amendments to the programme to bring it into line with the reality of the situation on those islands. To that end, more significant involvement on the part of the competent local and regional authorities and other stakeholders should be encouraged. Also in keeping with this approach, the procedure for amending the programme should be adapted to reflect the level of relevance of each type of amendment. (6) The particular geographical situation of some of the smaller Aegean islands imposes additional transport costs in supplying products which are essential for human consumption, for processing or as agricultural inputs. In addition, other objective factors arising as a result of insularity and distance from markets impose further constraints on economic operators and producers in those Aegean islands that severely handicap their activities. In certain cases, operators and producers suffer from ‘double insularity’, consisting of the fact that supplies are brought by way of other islands. Those handicaps can be alleviated by lowering the price of those essential products. It is therefore appropriate to introduce specific supply arrangements to guarantee supply to the smaller Aegean islands and compensate for the additional costs arising from their insularity, small size and distance from markets. (7) The problems experienced by the smaller Aegean islands are accentuated by the islands' small size. In order to guarantee the effectiveness of the measures envisaged, such measures should apply to all Aegean islands except Crete and Evia. (8) In order to achieve the goal of lowering prices in the smaller Aegean islands, mitigating the additional costs of their insularity, small size and distance from markets while maintaining the competitiveness of Union products, aid should be granted for the supply of Union products to the smaller Aegean islands. Such aid should take account of the additional cost of transport to the smaller Aegean islands and, in the case of agricultural inputs and products intended for processing, the additional costs of insularity, small size and distance from markets. (9) In order to avoid speculation which would be harmful to end-users in the smaller Aegean islands, it is important to specify that the specific supply arrangements may only apply to products of sound, fair and marketable quality. (10) Since the quantities covered by the specific supply arrangements are limited to the supply requirements of the smaller Aegean islands, those arrangements should not impair the proper functioning of the internal market. Nor should the economic advantages of the specific supply arrangements lead to diversions of trade in the products concerned. The dispatch or export of those products from the smaller Aegean islands should therefore be prohibited. However, dispatch or exportation of those products should be authorised where the advantage resulting from the specific supply arrangements is reimbursed. (11) With regard to processed products, trade between the smaller Aegean islands should be authorised and transport costs in respect of those products should be reduced, in order to allow commerce between those islands. Account should also be taken of trade flows within the context of regional commerce and traditional exports and dispatching with the rest of the Union or third countries and exports of processed products corresponding to traditional trade for all those regions should be authorised. (12) In order to achieve the objectives of the specific supply arrangements, the economic advantages of those arrangements should be reflected in production costs and should reduce prices up to the end-user stage. They should therefore be granted only on condition that they are actually passed on, and appropriate checks should be carried out. (13) Rules should be established concerning the operation of the scheme, particularly those relating to the creation of a register of operators and a system of certificates, based on the certificates referred to in Article 161 of Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (4). (14) Union policy to assist local production in the smaller Aegean islands, as established by Regulation (EC) No 1405/2006, has involved a multitude of products and measures for their production, marketing or processing. Those measures have proved effective and have ensured that agricultural activities have been maintained and developed. The Union should continue to support that production, which is a key factor in the environmental, social and economic equilibrium of the smaller Aegean islands. Experience has shown that, as in the case of rural development policy, closer partnership with the local authorities can help to address in a more targeted way the particular issues affecting the islands concerned. Support for local production should thus continue to be granted through the support programme, established for the first time by Regulation (EC) No 1405/2006. In that regard, emphasis should be placed on preserving the traditional agricultural heritage and the traditional characteristics of production methods and of local and organic products. (15) The minimum elements which should be provided under the support programme in order to establish the measures supporting local agricultural production, specifically the description of the location, of the strategy proposed, of the objectives and of the measures, should be established. The principles underlying the consistency of those measures with other Union policies should also be stated, in order to avoid any incompatibility and overlapping of aid. (16) For the purposes of applying this Regulation, it should also be possible for the support programme to contain measures for financing studies, demonstration projects, training and technical assistance. (17) Farmers on the smaller Aegean islands should be encouraged to supply quality products, and the marketing of such products should be assisted. (18) A derogation may be granted from the Commission's consistent policy of not authorising State operating aid for the production, processing, marketing and transportation of agricultural products listed in Annex I to the Treaty on the Functioning of the European Union (‘the Treaty’) in order to mitigate the specific constraints on farming in the smaller Aegean islands as a result of their insularity, small size, mountainous terrain and climate, their economic dependency on a small number of products and their distance from markets. (19) Implementation of this Regulation should not jeopardise the level of special support from which the smaller Aegean islands have benefited up to now. In order to be able to carry out the appropriate measures, Greece should continue to have at its disposal sums equivalent to the Union support already granted under Regulation (EC) No 1405/2006. (20) Since 2007, requirements in essential products have increased in the smaller Aegean islands as a result of an increasing livestock population and demographic pressure. The proportion of the budget which Greece should be able to use for the specific supply arrangements for the smaller Aegean islands should therefore be increased. (21) In order to allow Greece to evaluate all the elements concerning the implementation of the support programme for the previous year and make it possible to submit to the Commission a complete annual evaluation report, the submission date of that report should be postponed from 30 June to 30 September of the year following the reference year. (22) The Commission should be required to submit to the European Parliament and to the Council, by 31 December 2016 at the latest and thereafter every five years, a general report on the impact of measures taken to implement this Regulation accompanied, where appropriate, by suitable recommendations. (23) In order to ensure the proper functioning of the regime introduced by this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission, in respect of supplementing or modifying certain non-essential elements of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (24) In order to ensure uniform conditions for the implementation of the programme in the smaller Aegean islands in relation to other similar schemes and to avoid unfair competition or discrimination between operators, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (5). (25) In order to allow for the prompt application of the measures envisaged, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union, HAVE ADOPTED THIS REGULATION: CHAPTER I SUBJECT MATTER AND OBJECTIVES Article 1 Subject matter 1. This Regulation lays down specific measures for agriculture to mitigate the difficulties caused by the insularity, small size and distance from markets of the smaller Aegean islands (‘the smaller islands’). 2. For the purposes of this Regulation ‘the smaller islands’ means any islands in the Aegean Sea except the islands of Crete and Evia. Article 2 Objectives 1. The specific measures provided for in Article 1 shall help to meet the following objectives: (a) guaranteed supply to the smaller islands of products essential for human consumption or for processing and as agricultural inputs by mitigating the additional costs incurred due to their insularity, small size and distance from markets; (b) the preservation and development of agricultural activities in the smaller islands, including the production, processing, marketing and transport of local raw and processed products. 2. The objectives set out in paragraph 1 shall be implemented by means of the measures referred to in Chapters III, IV and V. CHAPTER II SUPPORT PROGRAMME Article 3 Establishing the support programme 1. The measures provided for in Article 1 shall be defined by a support programme comprising: (a) specific supply arrangements as provided for in Chapter III; and (b) specific measures to assist local agricultural production as provided for in Chapter IV. 2. The support programme shall be established at the geographical level which Greece deems to be the most appropriate. It shall be prepared by the competent local and regional authorities designated by Greece, which shall submit it to the Commission for approval in accordance with Article 6 after the competent authorities and organisations at the appropriate regional level have been consulted. Article 4 Compatibility and consistency 1. Measures taken under the support programme shall comply with Union law. Such measures shall be consistent with other Union policies and with the measures taken under such policies. 2. Consistency of the measures taken under the support programme with measures implemented under other instruments of the common agricultural policy, and in particular the common organisations of markets, rural development, product quality, animal welfare and the protection of the environment, shall be ensured. In particular, no measure under this Regulation shall be financed as: (a) additional support for premium or aid schemes under a common organisation of the market, save in exceptional cases, justified by objective criteria; (b) support for research projects, measures to support research projects or measures eligible for Union financing under Council Decision 2009/470/EC of 25 May 2009 on expenditure in the veterinary field (6); (c) support for measures within the scope of Council Regulation (EC) No 1698/2005 of 20 September 2005 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) (7). Article 5 Content of the support programme The support programme shall comprise: (a) a schedule for the implementation of the measures and a general annual indicative financing table showing the resources to be deployed; (b) proof of the compatibility and consistency between the various measures under the programme and with the criteria and quantitative indicators to be used for monitoring and evaluation; (c) the steps taken to ensure that the programme is implemented effectively and appropriately, including the arrangements for publicity, monitoring and evaluation, and a specified set of quantified indicators for use in programme evaluation; (d) the designation of the competent authorities and bodies responsible for implementing the programme and the designation at the appropriate levels of authorities or associated bodies and socio-economic partners, and the results of consultations held. Article 6 Approval and amendments of the programme 1. The support programme is established under Regulation (EC) No 1405/2006 and is financed under the financial allocation referred to in Article 18(2) and (3). The programme comprises a forecast supply balance indicating the products, the quantities thereof and the amount of aid for supply from the Union together with a draft programme of support for local production. 2. Depending on the annual evaluation of the implementation of measures included in the support programme, Greece may submit to the Commission duly substantiated proposals for amendments to those measures within the context of the financial allocation referred to in Article 18(2) and (3), to bring them more into line with the requirements of the smaller islands and the strategy proposed. The Commission shall adopt implementing acts laying down the procedures for assessing whether the amendments proposed comply with Union law and for deciding whether to approve them. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). 3. The procedures laid down by the implementing acts referred to in paragraph 2 may take account of the following elements: the importance of the modifications proposed by Greece with reference to the introduction of new measures, whether the changes to the budget allocated to the measures are substantial, changes in the quantities and in the level of aid for products in the forecast supply balances and any amendments to codes and descriptions laid down in Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (8). 4. The implementing acts referred to in paragraph 2 shall also determine, for each procedure, the frequency with which requests for amendments are to be made, as well as the time frames within which the approved amendments are to be implemented. Article 7 Monitoring and follow-up Greece shall conduct verifications by means of administrative and on-the-spot checks. The Commission shall adopt implementing acts regarding the minimum characteristics of the checks to be carried out by Greece. The Commission shall also adopt implementing acts regarding the procedures and physical and financial indicators in order to ensure that the implementation of the programmes is monitored in an effective manner. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). CHAPTER III SPECIFIC SUPPLY ARRANGEMENTS Article 8 Forecast supply balance 1. Specific supply arrangements are hereby established for the Union's agricultural products listed in Annex I to the Treaty (‘the agricultural products’) which are essential in the smaller islands for human consumption, for the manufacture of other products or as agricultural inputs. 2. Greece shall establish, at the geographical level which it deems most appropriate, a forecast supply balance so as to quantify the annual supply requirements for the smaller islands with regard to the agricultural products. A separate forecast balance may be drawn up for the requirements of undertakings packaging and processing products intended for the local market, for consignment to the rest of the Union or for export to third countries as part of regional trade, in accordance with Article 13(2) and (3), or within the context of traditional trade flows. Article 9 Operation of the specific supply arrangements 1. Aid shall be granted to supply the smaller islands with agricultural products. The amount of the aid shall be determined for each product concerned, taking account of the additional costs of marketing products in the smaller islands, calculated from the usual ports of shipment in mainland Greece, and from the ports of islands of transit or of loading for the islands of final destination. In the case of agricultural inputs and products intended for processing, such aid should take account of the additional costs associated with insularity, small size and distance from markets. 2. The specific supply arrangements shall only apply to products of sound, fair and marketable quality. Article 10 Implementation In implementing the specific supply arrangements, account shall be taken, in particular, of the following: (a) the specific needs of the smaller islands and the precise quality requirements; (b) traditional trade flows with ports in mainland Greece and between the islands in the Aegean Sea; (c) the economic aspect of the proposed aid; (d) where applicable, the need not to obstruct the development of local products. Article 11 Certificates 1. The aid provided for in Article 9(1) shall be granted on presentation of a certificate. Certificates shall be issued only to operators entered in a register held by the competent authorities. Those certificates shall not be transferable. 2. No security shall be required when applying for a certificate. However, to the extent necessary to ensure the proper application of this Regulation, the competent authority may require a security to be lodged equal to the amount of the advantage as referred to in Article 12. In such cases, Article 34(1), (4), (5), (6), (7) and (8) of Commission Regulation (EC) No 376/2008 of 23 April 2008 laying down common detailed rules for the application of the system of import and export licences and advance fixing certificates for agricultural products (9) shall apply. The Commission shall be empowered to adopt delegated acts, in accordance with Article 21, determining the conditions for recording operators in the register and providing for the full exercise by operators of their rights to participate in the specific supply arrangements. 3. The Commission shall adopt implementing acts concerning the measures necessary to ensure the uniform application by Greece of this Article, specifically relating to the introduction of the system of certificates, and the commitment undertaken by operators at the time of registration. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). Article 12 Impact of advantage 1. Benefiting from the specific supply arrangements resulting from the awarding of aid shall be subject to the condition that the impact of the economic advantage is passed on up to the end-user who, as appropriate, may be the consumer in the case of products meant for direct consumption, the end processor or packager in the case of products meant for the processing or packaging industries, or farmers in the case of products used for animal feed or as agricultural inputs. The advantage referred to in the first subparagraph shall be equal to the amount of the aid. 2. In order to ensure that paragraph 1 is applied in a uniform manner, the Commission shall adopt implementing acts regarding the application of the rules set out in paragraph 1 and more specifically regarding the conditions for the monitoring, by the Member State, that the advantage has in fact been passed on up to the end-user. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). Article 13 Export to third countries and dispatch to the rest of the Union 1. The Commission shall adopt implementing acts establishing the requirements in accordance with which products covered by the specific supply arrangements may be exported to third countries or dispatched to the rest of the Union. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). Those requirements shall include in particular reimbursement of the aid received under the specific supply arrangements. Exports to third countries of products covered by the specific supply arrangements shall not be subject to the presentation of a certificate. 2. The first subparagraph of paragraph 1 shall not apply to products processed in the smaller islands from products that have benefited from the specific supply arrangements which are: (a) exported to third countries or dispatched to the rest of the Union within the limits of traditional exports and traditional dispatches; (b) exported to third countries as part of regional trade in accordance with the destinations and detailed provisions to be determined by the Commission; (c) dispatched between the smaller islands. Exports to third countries of products referred to in points (a) and (b) of the first subparagraph shall not be subject to the presentation of a certificate. No export refund shall be granted on the export of products referred to in points (a) and (b) of the first subparagraph. The Commission shall adopt implementing acts establishing the limits of the quantities of products referred to in point (a) and the detailed provisions referred to in point (b). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). 3. Processing operations which may give rise to traditional trade exports or traditional dispatches shall fulfil, mutatis mutandis, the processing conditions applicable under customs control provided for in the relevant Union legislation, with the exception of all usual forms of handling. Article 14 Controls and penalties 1. The agricultural products which are the subject of the specific supply arrangements shall be subject to administrative checks at the time that they enter the smaller islands as well as when they are exported or dispatched. The Commission shall adopt implementing acts concerning the minimum characteristics of the checks to be carried out by Greece. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). 2. Except in cases of force majeure or exceptional climatic conditions, if an operator, as referred to in Article 11, fails to comply with the commitments made in accordance with that Article, the competent authority, without prejudice to any penalties applicable under national law, shall: (a) recover the advantage granted to the operator; (b) temporarily suspend or revoke the operator's registration, depending on the seriousness of the non-compliance. 3. Except in cases of force majeure or exceptional climatic conditions, where operators, as referred to in Article 11, do not carry out the planned entry, their entitlement to apply for certificates shall be suspended by the competent authority for a period of 60 days following expiry of that certificate. After the suspension period, the issue of subsequent certificates shall be subject to the lodging of a security equal to the amount of the advantage to be granted during a period to be determined by the competent authority. The competent authority shall adopt the measures required to reutilise any quantities of products made available as a result of non-execution, partial execution or cancellation of the certificates issued or recovery of the advantage. CHAPTER IV MEASURES TO ASSIST LOCAL AGRICULTURAL PRODUCTS Article 15 Measures 1. The support programme contains the measures necessary in order to ensure continuity and development of local lines of agricultural production in the smaller islands under the scope of Part Three, Title III of the Treaty. 2. The part of the programme which includes measures to assist local agricultural production shall comprise at least the following elements: (a) a quantified description of the current agricultural production situation, taking into account the results of available evaluations, showing disparities, gaps and potential for development and the financial resources deployed; (b) a description of the strategy proposed, the priorities selected, its quantified general and operational objectives, and an appraisal showing the expected economic, environmental and social impact, including employment effects; (c) a description of the measures envisaged, and in particular aid schemes for implementing them, and, where appropriate, information on the need for any studies, demonstration projects, training or technical assistance operations relating to the preparation, implementation or adaptation of the measures concerned; (d) a list of the aid constituting direct payments in accordance with Article 2(d) of Council Regulation (EC) No 73/2009 of 19 January 2009 establishing common rules for direct support schemes for farmers under the common agricultural policy and establishing certain support schemes for farmers (10); (e) the aid amount established for each measure and the provisional amount for each action in order to achieve one or more objectives for the programme. 3. The Commission shall adopt implementing acts concerning requirements for the provision of the aid described in paragraph 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). 4. The programme may include measures to support production, processing, marketing and transport of raw and processed agricultural products in the smaller islands. Each measure may include a variety of actions. For each action, the programme shall define at least the following elements: (a) the beneficiaries; (b) the eligibility conditions; (c) the unit amount of aid. The Commission shall adopt delegated acts in accordance with Article 21 concerning the conditions for establishing the amount of aid awarded in respect of the support for the marketing and transport of raw and processed products outside the region in which they are produced, and, where appropriate, concerning the conditions for establishing the quantities of products subject to that aid. Article 16 Controls and wrongful payments 1. Verification of measures provided for in this Chapter shall be conducted by administrative and on-the-spot checks. 2. In the event of wrongful payments, the beneficiary concerned shall be required to reimburse the amounts in question. Article 80 of Commission Regulation (EC) No 1122/2009 of 30 November 2009 laying down detailed rules for the implementation of Council Regulation (EC) No 73/2009 as regards cross-compliance, modulation and the integrated administration and control system, under the direct support schemes for farmers provided for that Regulation, as well as for the implementation of Council Regulation (EC) No 1234/2007 as regards cross-compliance under the support scheme provided for the wine sector (11) shall apply mutatis mutandis. CHAPTER V ACCOMPANYING MEASURES Article 17 State aid 1. For the agricultural products covered by Annex I to the Treaty, to which Articles 107, 108 and 109 thereof apply, the Commission may authorise, in accordance with Article 108 of the Treaty, operating aid in the sectors producing, processing, marketing and transporting those products, with a view to alleviating the specific constraints on farming in the smaller islands as a result of their insularity, small size, mountainous terrain and climate, their economic dependency on a small number of products and their distance from markets. 2. Greece may grant additional financing for the implementation of the support programme. In such cases, Greece shall notify the Commission of the State aid and the Commission may approve it in accordance with this Regulation as part of the support programme. Aid thus notified shall be deemed to have been notified within the meaning of the first sentence of Article 108(3) of the Treaty. 3. Without prejudice to paragraphs 1 and 2 of this Article and by way of derogation from Article 180 of Regulation (EC) No 1234/2007 and Article 3 of Council Regulation (EC) No 1184/2006 of 24 July 2006 applying certain rules of competition to the production of and trade in agricultural products (12), Articles 107, 108 and 109 of the Treaty shall not apply to payments made under Chapters III and IV of this Regulation by Greece in conformity with this Regulation. CHAPTER VI FINANCIAL PROVISIONS Article 18 Financial resources 1. The measures provided for in this Regulation shall constitute intervention intended to stabilise the agricultural markets within the meaning of Article 3(1)(b) of Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (13). 2. The Union shall finance the measures provided for in Chapters III and IV up to a maximum annual amount of EUR 23,93 million. 3. The amount allocated annually to finance the specific supply arrangements referred to in Chapter III shall not exceed EUR 7,11 million. The Commission shall adopt implementing acts establishing the requirements in accordance with which Greece may amend the allocation of resources allocated each year to the various products benefiting from the specific supply arrangements. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). 4. The Commission shall adopt delegated acts, in accordance with Article 21, concerning the conditions for determining the annual maximum amount which may be allocated to measures for financing studies, demonstration projects, training and technical assistance, provided that such allocation is reasonable and proportionate. CHAPTER VII GENERAL AND FINAL PROVISIONS Article 19 National measures Greece shall take the measures necessary to ensure compliance with this Regulation, in particular as regards checks and administrative penalties, and shall inform the Commission thereof. Article 20 Communications and reports 1. Greece shall communicate to the Commission not later than 15 February each year the appropriations made available to it which it intends to spend in the following year on implementation of the forecast supply balance and for each measure promoting local agricultural production included in the support programme. 2. Greece shall submit to the Commission no later than 30 September each year a report on the implementation of the measures provided for in this Regulation over the previous year. 3. By 31 December 2016, and thereafter every five years, the Commission shall submit a general report to the European Parliament and to the Council showing the impact of the action taken under this Regulation, accompanied, if applicable, by appropriate proposals. Article 21 Exercise of the delegation 1. The power to adopt delegated acts shall be conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 11(2), Article 15(4) and Article 18(4) shall be conferred on the Commission for a period of five years from 21 March 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 11(2), Article 15(4) and Article 18(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision to revoke in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. The delegated acts adopted pursuant to Article 11(2), Article 15(4) and Article 18(4) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they do not intend to raise any objections. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 22 Committee procedure 1. The Commission shall be assisted by the Management Committee for Direct Payments established under Article 141 of Regulation (EC) No 73/2009. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 23 Repeal Regulation (EC) No 1405/2006 is hereby repealed. References made to the repealed Regulation shall be construed as being made to this Regulation and shall be read in accordance with the correlation table set out in the Annex. Article 24 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 13 March 2013. For the European Parliament The President M. SCHULZ For the Council The President L. CREIGHTON (1) OJ C 132, 3.5.2011, p. 82. (2) Position of the European Parliament of 5 February 2013 (not yet published in the Official Journal) and decision of the Council of 25 February 2013. (3) OJ L 265, 26.9.2006, p. 1. (4) OJ L 299, 16.11.2007, p. 1. (5) OJ L 55, 28.2.2011, p. 13. (6) OJ L 155, 18.6.2009, p. 30. (7) OJ L 277, 21.10.2005, p. 1. (8) OJ L 256, 7.9.1987, p. 1. (9) OJ L 114, 26.4.2008, p. 3. (10) OJ L 30, 31.1.2009, p. 16. (11) OJ L 316, 2.12.2009, p. 65. (12) OJ L 214, 4.8.2006, p. 7. (13) OJ L 209, 11.8.2005, p. 1. ANNEX Correlation table Regulation (EC) No 1405/2006 This Regulation Article 1 Article 1 Article 2 Article 3(1) Article 3 Article 8 Article 4(1) Article 9(1) Article 4(2) Article 10 Article 4(3) Article 12(1) Article 5 Article 13 Article 7(1) Article 15(1) Article 7(2) Article 3(2) Article 8 Article 4 Article 9(a) and (b) Article 15(2) Article 9(c), (d), (e) and (f) Article 5 Article 10 Article 7 second paragraph Article 11 Article 17 Article 12 Article 18 Article 13 Article 6(1) Article 14(a) Article 6(2) to (4) Article 14(b) Article 7 first paragraph, and Article 14(1) second subparagraph, (2) and (3) Article 16 Article 19 Article 17 Article 20 Article 18 Article 23 Article 21 Article 24

Farmers in the Aegean islands - EU support Farmers in the Aegean islands - EU support The European Union has special rules to assist agriculture in the smaller Aegean islands that are affected by geographical and economic factors. ACT Regulation (EU) No 229/2013 of the European Parliament and of the Council of 13 March 2013 laying down specific measures for agriculture in favour of the smaller Aegean islands and repealing Council Regulation (EC) No 1405/2006. SUMMARY WHAT DOES THIS REGULATION DO? It allows for special arrangements that aim to compensate these islands for the difficulties they face due to their remote location. It has two aims: 1.to guarantee the supply to these smaller islands of products that are essential for human consumption or processing, as well as agricultural inputs, at a cost that compensates for their isolation; 2.to ensure, in the longer term, the continuity and development of local production. KEY POINTS Management and budget Greece decides on the appropriate geographical level at which to establish the programme and submits it to the Commission for approval. Each year, an amount of €23.93 million (of which no more than €7.11 million can be used to finance special supply arrangements) is available from the EU budget, as laid down in Article 18(2) and (3) of the regulation. Specific supply arrangements Where these are agreed, they are granted on condition that the impact of the economic advantage is passed on to the end-user who, as appropriate, may be the consumer in the case of products meant for direct consumption, the end processor or packager in the case of products meant for the processing or packaging industries or farmers in the case of products used for animal feed or as agricultural inputs. The advantage is calculated as being equal to the amount of the aid. The managing authority may require a security to be lodged equal to the amount of the advantage. Measures to assist local agricultural products The programme may include measures to support the production, processing or sale of agricultural products in the outermost regions. Each measure may include a variety of actions. For each action, the programme must define at least the beneficiaries, the eligibility conditions and the unit amount of aid allocated to that action. Checks and penalties Products that are the subject of specific supply arrangements are checked when they enter the smaller Aegean islands, as well as when they are exported or dispatched. Where the rules are not respected, the authorities may recover the advantage granted to operators (i.e. farmers and companies that own farms) and temporarily suspend/revoke their registration. Measures to assist local agricultural products are verified by means of both administrative and on-the-spot checks. In the event of a wrongful payment, the beneficiary concerned is obliged to reimburse the amount in question. WHEN DOES THIS REGULATION APPLY? From 21 March 2013. Regulation (EU) No 229/2013 repeals Regulation (EC) No 1405/2006. For further information, see the section on POSEI programmes and specific measures in favour of the smaller Aegean islands on the European Commission’s website. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 229/2013 21.3.2013 - OJ L 78, 20.3.2013, pp. 41-50 last update 16.03.2015

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14.11.2012 EN Official Journal of the European Union L 316/1 REGULATION (EU) No 1024/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 on administrative cooperation through the Internal Market Information System and repealing Commission Decision 2008/49/EC (‘the IMI Regulation’) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The application of certain Union acts governing the free movement of goods, persons, services and capital in the internal market requires Member States to cooperate more effectively and exchange information with one another and with the Commission. As practical means to implement such information exchange are often not specified in those acts, appropriate practical arrangements need to be made. (2) The Internal Market Information System (‘IMI’) is a software application accessible via the internet, developed by the Commission in cooperation with the Member States, in order to assist Member States with the practical implementation of information exchange requirements laid down in Union acts by providing a centralised communication mechanism to facilitate cross-border exchange of information and mutual assistance. In particular, IMI helps competent authorities to identify their counterpart in another Member State, to manage the exchange of information, including personal data, on the basis of simple and unified procedures and to overcome language barriers on the basis of pre-defined and pre-translated workflows. Where available, the Commission should provide IMI users with any existing additional translation functionality that meets their needs, is compatible with the security and confidentiality requirements for the exchange of information in IMI and can be offered at a reasonable cost. (3) In order to overcome language barriers, IMI should in principle be available in all official Union languages. (4) The purpose of IMI should be to improve the functioning of the internal market by providing an effective, user-friendly tool for the implementation of administrative cooperation between Member States and between Member States and the Commission, thus facilitating the application of Union acts listed in the Annex to this Regulation. (5) The Commission Communication of 21 February 2011 entitled ‘Better governance of the Single Market through greater administrative cooperation: A strategy for expanding and developing the Internal Market Information System (“IMI”)’ sets out plans for the possible expansion of IMI to other Union acts. The Commission Communication of 13 April 2011 entitled ‘Single Market Act: Twelve Levers to boost growth and strengthen confidence — “Working together to create new growth”’ stresses the importance of IMI for strengthening cooperation among the actors involved, including at local level, thus contributing to better governance of the single market. It is therefore necessary to establish a sound legal framework for IMI and a set of common rules to ensure that IMI functions efficiently. (6) Where the application of a provision of a Union act requires Member States to exchange personal data and provides for the purpose of this processing, such a provision should be considered an adequate legal basis for the processing of personal data, subject to the conditions set out in Articles 8 and 52 of the Charter of Fundamental Rights of the European Union. IMI should be seen primarily as a tool used for the exchange of information, including personal data, which would otherwise take place via other means, including regular mail, fax or electronic mail on the basis of a legal obligation imposed on Member States’ authorities and bodies in Union acts. Personal data exchanged via IMI should only be collected, processed and used for purposes in line with those for which it was originally collected and should be subject to all relevant safeguards. (7) Following the privacy-by-design principle, IMI has been developed with the requirements of data protection legislation in mind and has been data protection-friendly from its inception, in particular because of the restrictions imposed on access to personal data exchanged in IMI. Therefore, IMI offers a considerably higher level of protection and security than other methods of information exchange such as regular mail, telephone, fax or electronic mail. (8) Administrative cooperation by electronic means between Member States and between Member States and the Commission should comply with the rules on the protection of personal data laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (3) and in Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (4). The definitions used in Directive 95/46/EC and Regulation (EC) No 45/2001 should also apply for the purposes of this Regulation. (9) The Commission supplies and manages the software and IT infrastructure for IMI, ensures the security of IMI, manages the network of national IMI coordinators and is involved in the training of and technical assistance to the IMI users. To that end, the Commission should only have access to such personal data that are strictly necessary to carry out its tasks within the responsibilities set out in this Regulation, such as the registration of national IMI coordinators. The Commission should also have access to personal data when retrieving, upon a request by another IMI actor, such data that have been blocked in IMI and to which the data subject has requested access. The Commission should not have access to personal data exchanged as part of administrative cooperation within IMI, unless a Union act provides for a role for the Commission in such cooperation. (10) In order to ensure transparency, in particular for data subjects, the provisions of Union acts for which IMI is to be used should be listed in the Annex to this Regulation. (11) IMI may be expanded in the future to new areas, where it can help to ensure effective implementation of a Union act in a cost-efficient, user-friendly way, taking account of technical feasibility and overall impact on IMI. The Commission should conduct the necessary tests to verify the technical readiness of IMI for any envisaged expansion. Decisions to expand IMI to further Union acts should be taken by means of the ordinary legislative procedure. (12) Pilot projects are a useful tool for testing whether the expansion of IMI is justified and for adapting technical functionality and procedural arrangements to the requirements of IMI users before a decision on the expansion of IMI is taken. Member States should be fully involved in deciding which Union acts should be subject to a pilot project and on the modalities of that pilot project, in order to ensure that the pilot project reflects the needs of IMI users and that the provisions on processing of personal data are fully complied with. Such modalities should be defined separately for each pilot project. (13) Nothing in this Regulation should preclude Member States and the Commission from deciding to use IMI for the exchange of information which does not involve the processing of personal data. (14) This Regulation should set out the rules for using IMI for the purposes of administrative cooperation, which may cover, inter alia, the one-to-one exchange of information, notification procedures, alert mechanisms, mutual assistance arrangements and problem-solving. (15) The right of the Member States to decide which national authorities carry out the obligations resulting from this Regulation should remain unaffected by this Regulation. Member States should be able to adapt functions and responsibilities in relation to IMI to their internal administrative structures, as well as to implement the needs of a specific IMI workflow. Member States should be able to appoint additional IMI coordinators to carry out the tasks of national IMI coordinators, alone or jointly with others, for a particular area of the internal market, a division of the administration, a geographic region, or according to another criterion. Member States should inform the Commission of the IMI coordinators they have appointed, but they should not be obliged to indicate additional IMI coordinators in IMI, where this is not required for its proper functioning. (16) In order to achieve efficient administrative cooperation through IMI, Member States and the Commission should ensure that their IMI actors have the necessary resources to carry out their obligations in accordance with this Regulation. (17) While IMI is in essence a communication tool for administrative cooperation between competent authorities, which is not open to the general public, technical means may need to be developed to allow external actors such as citizens, enterprises and organisations to interact with the competent authorities in order to supply information or retrieve data, or to exercise their rights as data subjects. Such technical means should include appropriate safeguards for data protection. In order to ensure a high level of security, any such public interface should be developed in such a way as to be technically fully separate from IMI, to which only IMI users should have access. (18) The use of IMI for the technical support of the SOLVIT network should be without prejudice to the informal character of the SOLVIT procedure which is based on a voluntary commitment of the Member States, in accordance with the Commission Recommendation of 7 December 2001 on principles for using ‘SOLVIT’ — the Internal Market Problem Solving Network (5) (‘the SOLVIT Recommendation’). To continue the functioning of the SOLVIT network on the basis of existing work arrangements, one or more tasks of the national IMI coordinator may be assigned to SOLVIT centres within the remit of their work, so that they can function independently from the national IMI coordinator. The processing of personal data and of confidential information as part of SOLVIT procedures should benefit from all guarantees set out in this Regulation, without prejudice to the non-binding character of the SOLVIT Recommendation. (19) While IMI includes an internet-based interface for its users, in certain cases and at the request of the Member State concerned, it may be appropriate to consider technical solutions for the direct transfer of data from national systems to IMI, where such national systems have already been developed, notably for notification procedures. The implementation of such technical solutions should depend on the outcome of an assessment of their feasibility, costs and expected benefits. Those solutions should not affect the existing structures and the national order of competencies. (20) Where Member States have fulfilled the obligation to notify under Article 15(7) of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (6) by using the procedure in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (7), they should not also be required to make the same notification through IMI. (21) The exchange of information through IMI follows from the legal obligation on Member States’ authorities to give mutual assistance. To ensure that the internal market functions properly, information received by a competent authority through IMI from another Member State should not be deprived of its value as evidence in administrative proceedings solely on the ground that it originated in another Member State or was received by electronic means, and it should be treated by that competent authority in the same way as similar documents originating in its Member State. (22) In order to guarantee a high level of data protection, maximum retention periods for personal data in IMI need to be established. However, those periods should be well-balanced taking into due consideration the need for IMI to function properly, as well as the rights of the data subjects to fully exercise their rights, for instance by obtaining evidence that an information exchange took place in order to appeal against a decision. In particular, retention periods should not go beyond what is necessary to achieve the objectives of this Regulation. (23) It should be possible to process the name and contact details of IMI users for purposes compatible with the objectives of this Regulation, including monitoring of the use of the system by IMI coordinators and the Commission, communication, training and awareness-raising initiatives, and gathering information on administrative cooperation or mutual assistance in the internal market. (24) The European Data Protection Supervisor should monitor and seek to ensure the application of this Regulation, inter alia by maintaining contacts with national data protection authorities, including the relevant provisions on data security. (25) In order to ensure the effective monitoring of, and reporting on, the functioning of IMI and the application of this Regulation, Member States should make relevant information available to the Commission. (26) Data subjects should be informed about the processing of their personal data in IMI and of the fact that they have the right of access to the data relating to them and the right to have inaccurate data corrected and illegally processed data erased, in accordance with this Regulation and national legislation implementing Directive 95/46/EC. (27) In order to make it possible for the competent authorities of the Member States to implement legal provisions for administrative cooperation and efficiently exchange information by means of IMI, it may be necessary to lay down practical arrangements for such an exchange. Those arrangements should be adopted by the Commission in the form of a separate implementing act for each Union act listed in the Annex or for each type of administrative cooperation procedure and should cover the essential technical functionality and procedural arrangements required to implement the relevant administrative cooperation procedures via IMI. The Commission should ensure the maintenance and development of the software and IT infrastructure for IMI. (28) In order to ensure sufficient transparency for data subjects, the predefined workflows, question and answer sets, forms and other arrangements relating to administrative cooperation procedures in IMI should be made public. (29) Where Member States apply, in accordance with Article 13 of Directive 95/46/EC, any limitations on or exceptions to the rights of data subjects, information about such limitations or exceptions should be made public in order to ensure full transparency for data subjects. Such exceptions or limitations should be necessary and proportionate to the intended purpose and subject to adequate safeguards. (30) Where international agreements are concluded between the Union and third countries that also cover the application of provisions of Union acts listed in the Annex to this Regulation, it should be possible to include the counterparts of IMI actors in such third countries in the administrative cooperation procedures supported by IMI, provided that it has been established that the third country concerned offers an adequate level of protection of personal data in accordance with Directive 95/46/EC. (31) Commission Decision 2008/49/EC of 12 December 2007 concerning the implementation of the Internal Market Information System (IMI) as regards the protection of personal data (8) should be repealed. Commission Decision 2009/739/EC of 2 October 2009 setting out the practical arrangements for the exchange of information by electronic means between the Member States under Chapter VI of Directive 2006/123/EC of the European Parliament and of the Council on services in the internal market (9) should continue to apply to issues relating to the exchange of information under Directive 2006/123/EC. (32) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (10). (33) The performance of the Member States regarding the effective application of this Regulation should be monitored in the annual report on the functioning of IMI based on statistical data from IMI and any other relevant data. The performance of Member States should be evaluated, inter alia, based on average reply times with the aim of ensuring rapid replies of good quality. (34) Since the objective of this Regulation, namely laying down the rules for the use of IMI for administrative cooperation, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (35) The European Data Protection Supervisor has been consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 22 November 2011 (11), HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation lays down rules for the use of an Internal Market Information System (‘IMI’) for administrative cooperation, including processing of personal data, between competent authorities of the Member States and between competent authorities of the Member States and the Commission. Article 2 Establishment of IMI IMI is hereby formally established. Article 3 Scope 1. IMI shall be used for administrative cooperation between competent authorities of the Member States and between competent authorities of the Member States and the Commission necessary for the implementation of Union acts in the field of the internal market, within the meaning of Article 26(2) of the Treaty on the Functioning of the European Union (TFEU), which provide for administrative cooperation, including the exchange of personal data, between Member States or between Member States and the Commission. Those Union acts are listed in the Annex. 2. Nothing in this Regulation shall have the effect of rendering mandatory the provisions of Union acts which have no binding force. Article 4 Expansion of IMI 1. The Commission may carry out pilot projects in order to assess whether IMI would be an effective tool to implement provisions for administrative cooperation of Union acts not listed in the Annex. The Commission shall adopt an implementing act to determine which provisions of Union acts shall be subject to a pilot project and to set out the modalities of each project, in particular the basic technical functionality and procedural arrangements required to implement the relevant administrative cooperation provisions. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 24(3). 2. The Commission shall submit an evaluation of the outcome of the pilot project, including data protection issues and effective translation functionalities, to the European Parliament and the Council. Where appropriate, that evaluation may be accompanied by a legislative proposal to amend the Annex to expand the use of IMI to the relevant provisions of Union acts. Article 5 Definitions For the purposes of this Regulation, the definitions laid down in Directive 95/46/EC and Regulation (EC) No 45/2001 shall apply. In addition, the following definitions shall also apply: (a) ‘IMI’ means the electronic tool provided by the Commission to facilitate administrative cooperation between competent authorities of the Member States and between competent authorities of the Member States and the Commission; (b) ‘administrative cooperation’ means the working in collaboration of competent authorities of the Member States or competent authorities of the Member States and the Commission, by exchanging and processing information, including through notifications and alerts, or by providing mutual assistance, including for the resolution of problems, for the purpose of better application of Union law; (c) ‘internal market area’ means a legislative or functional field of the internal market, within the meaning of Article 26(2) TFEU, in which IMI is used in accordance with Article 3 of this Regulation; (d) ‘administrative cooperation procedure’ means a pre-defined workflow provided for in IMI allowing IMI actors to communicate and interact with each other in a structured manner; (e) ‘IMI coordinator’ means a body appointed by a Member State to perform support tasks necessary for the efficient functioning of IMI in accordance with this Regulation; (f) ‘competent authority’ means any body established at either national, regional or local level and registered in IMI with specific responsibilities relating to the application of national law or Union acts listed in the Annex in one or more internal market areas; (g) ‘IMI actors’ means the competent authorities, IMI coordinators and the Commission; (h) ‘IMI user’ means a natural person working under the authority of an IMI actor and registered in IMI on behalf of that IMI actor; (i) ‘external actors’ means natural or legal persons other than IMI users that may interact with IMI only through separate technical means and in accordance with a specific pre-defined workflow provided for that purpose; (j) ‘blocking’ means applying technical means by which personal data become inaccessible to IMI users via the normal interface of IMI; (k) ‘formal closure’ means applying the technical facility provided by IMI to close an administrative cooperation procedure. CHAPTER II FUNCTIONS AND RESPONSIBILITIES IN RELATION TO IMI Article 6 IMI coordinators 1. Each Member State shall appoint one national IMI coordinator whose responsibilities shall include: (a) registering or validating registration of IMI coordinators and competent authorities; (b) acting as the main contact point for IMI actors of the Member States for issues relating to IMI, including providing information on aspects relating to the protection of personal data in accordance with this Regulation; (c) acting as interlocutor of the Commission for issues relating to IMI including providing information on aspects relating to the protection of personal data in accordance with this Regulation; (d) providing knowledge, training and support, including basic technical assistance, to IMI actors of the Member States; (e) ensuring the efficient functioning of IMI as far as it is within their control, including the provision of timely and adequate responses by IMI actors of the Member States to requests for administrative cooperation. 2. Each Member State may, in addition, appoint one or more IMI coordinators in order to carry out any of the tasks listed in paragraph 1, in accordance with its internal administrative structure. 3. Member States shall inform the Commission of the IMI coordinators appointed in accordance with paragraphs 1 and 2 and of the tasks for which they are responsible. The Commission shall share that information with the other Member States. 4. All IMI coordinators may act as competent authorities. In such cases an IMI coordinator shall have the same access rights as a competent authority. Each IMI coordinator shall be a controller with respect to its own data processing activities as an IMI actor. Article 7 Competent authorities 1. When cooperating by means of IMI, competent authorities, acting through IMI users in accordance with administrative cooperation procedures, shall ensure that, in accordance with the applicable Union act, an adequate response is provided within the shortest possible period of time, and in any event within the deadline set by that act. 2. A competent authority may invoke as evidence any information, document, finding, statement or certified true copy which it has received electronically by means of IMI, on the same basis as similar information obtained in its own country, for purposes compatible with the purposes for which the data were originally collected. 3. Each competent authority shall be a controller with respect to its own data processing activities performed by an IMI user under its authority and shall ensure that data subjects can exercise their rights in accordance with Chapters III and IV, where necessary, in cooperation with the Commission. Article 8 Commission 1. The Commission shall be responsible for carrying out the following tasks: (a) ensuring the security, availability, maintenance and development of the software and IT infrastructure for IMI; (b) providing a multilingual system, including existing translation functionalities, training in cooperation with the Member States, and a helpdesk to assist Member States in the use of IMI; (c) registering the national IMI coordinators and granting them access to IMI; (d) performing processing operations on personal data in IMI, where provided for in this Regulation, in accordance with the purposes determined by the applicable Union acts listed in the Annex; (e) monitoring the application of this Regulation and reporting back to the European Parliament, the Council and the European Data Protection Supervisor in accordance with Article 25. 2. For the purposes of performing the tasks listed in paragraph 1 and producing statistical reports, the Commission shall have access to the necessary information relating to the processing operations performed in IMI. 3. The Commission shall not participate in administrative cooperation procedures involving the processing of personal data except where required by a provision of a Union act listed in the Annex. Article 9 Access rights of IMI actors and users 1. Only IMI users shall have access to IMI. 2. Member States shall designate the IMI coordinators and competent authorities and the internal market areas in which they have competence. The Commission may play a consultative role in that process. 3. Each IMI actor shall grant and revoke, as necessary, appropriate access rights to its IMI users in the internal market area for which it is competent. 4. Appropriate means shall be put in place by the Commission and the Member States to ensure that IMI users are allowed to access personal data processed in IMI only on a need-to-know basis and within the internal market area or areas for which they were granted access rights in accordance with paragraph 3. 5. The use of personal data processed in IMI for a specific purpose in a way that is incompatible with that original purpose shall be prohibited, unless explicitly provided for by national law in accordance with Union law. 6. Where an administrative cooperation procedure involves the processing of personal data, only the IMI actors participating in that procedure shall have access to such personal data. Article 10 Confidentiality 1. Each Member State shall apply its rules of professional secrecy or other equivalent duties of confidentiality to its IMI actors and IMI users, in accordance with national or Union legislation. 2. IMI actors shall ensure that requests of other IMI actors for confidential treatment of information exchanged by means of IMI are respected by IMI users working under their authority. Article 11 Administrative cooperation procedures IMI shall be based on administrative cooperation procedures implementing the provisions of the relevant Union acts listed in the Annex. Where appropriate, the Commission may adopt implementing acts for a specific Union act listed in the Annex or for a type of administrative cooperation procedure, setting out the essential technical functionality and the procedural arrangements required to enable the operation of the relevant administrative cooperation procedures, including where applicable the interaction between external actors and IMI as referred to in Article 12. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). Article 12 External actors Technical means may be provided to allow external actors to interact with IMI where such interaction is: (a) provided for by a Union act; (b) provided for in an implementing act referred to in Article 11 in order to facilitate administrative cooperation between competent authorities in Member States for the application of the provisions of Union acts listed in the Annex; or (c) necessary for submitting requests in order to exercise their rights as data subjects in accordance with Article 19. Any such technical means shall be separate from IMI and shall not enable external actors to access IMI. CHAPTER III PROCESSING OF PERSONAL DATA AND SECURITY Article 13 Purpose limitation IMI actors shall exchange and process personal data only for the purposes defined in the relevant provisions of the Union acts listed in the Annex. Data submitted to IMI by data subjects shall only be used for the purposes for which the data were submitted. Article 14 Retention of personal data 1. Personal data processed in IMI shall be blocked in IMI as soon as they are no longer necessary for the purpose for which they were collected, depending on the specificities of each type of administrative cooperation and, as a general rule, no later than six months after the formal closure of the administrative cooperation procedure. However, if a longer period is provided for in an applicable Union act listed in the Annex, personal data processed in IMI may be retained for a maximum of 18 months after the formal closure of an administrative cooperation procedure. 2. Where a repository of information for future reference by IMI actors is required pursuant to a binding Union act listed in the Annex, the personal data included in such a repository may be processed for as long as they are needed for this purpose either with the data subject’s consent or where this is provided for in that Union act. 3. Personal data blocked pursuant to this Article shall, with the exception of their storage, only be processed for purposes of proof of an information exchange by means of IMI with the data subject’s consent, unless processing is requested for overriding reasons in the public interest. 4. The blocked data shall be automatically deleted in IMI three years after the formal closure of the administrative cooperation procedure. 5. At the express request of a competent authority in a specific case and with the data subject’s consent, personal data may be deleted before the expiry of the applicable retention period. 6. The Commission shall ensure by technical means the blocking and deletion of personal data and their retrieval in accordance with paragraph 3. 7. Technical means shall be put in place to encourage IMI actors to formally close administrative cooperation procedures as soon as possible after the exchange of information has been completed and to enable IMI actors to involve IMI coordinators responsible in any procedure which has been inactive without justification for longer than two months. Article 15 Retention of personal data of IMI users 1. By way of derogation from Article 14, paragraphs 2 and 3 of this Article shall apply to the retention of personal data of IMI users. Those personal data shall include the full name and all electronic and other means of contact necessary for the purposes of this Regulation. 2. Personal data relating to IMI users shall be stored in IMI as long as they continue to be users of IMI and may be processed for purposes compatible with the objectives of this Regulation. 3. When a natural person ceases to be an IMI user, the personal data relating to that person shall be blocked by technical means for a period of three years. Those data shall, with the exception of their storage, only be processed for purposes of proof of an information exchange by means of IMI and shall be deleted at the end of the three-year period. Article 16 Processing of special categories of data 1. The processing of special categories of data referred to in Article 8(1) of Directive 95/46/EC and Article 10(1) of Regulation (EC) No 45/2001 by means of IMI shall be allowed only on the basis of a specific ground mentioned in Article 8(2) and (4) of that Directive and Article 10(2) of that Regulation and subject to appropriate safeguards provided for in those Articles to ensure the rights of individuals whose personal data are processed. 2. IMI may be used for the processing of data relating to offences, criminal convictions or security measures referred to in Article 8(5) of Directive 95/46/EC and Article 10(5) of Regulation (EC) No 45/2001, subject to safeguards provided for in those Articles, including information on disciplinary, administrative or criminal sanctions or other information necessary to establish the good repute of an individual or a legal person, where the processing of such data is provided for in a Union act constituting the basis for the processing or with the explicit consent of the data subject, subject to specific safeguards referred to in Article 8(5) of Directive 95/46/EC. Article 17 Security 1. The Commission shall ensure that IMI complies with the rules on data security adopted by the Commission pursuant to Article 22 of Regulation (EC) No 45/2001. 2. The Commission shall put in place the necessary measures to ensure security of personal data processed in IMI, including appropriate data access control and a security plan which shall be kept up-to-date. 3. The Commission shall ensure that, in the event of a security incident, it is possible to verify what personal data have been processed in IMI, when, by whom and for what purpose. 4. IMI actors shall take all procedural and organisational measures necessary to ensure the security of personal data processed by them in IMI in accordance with Article 17 of Directive 95/46/EC. CHAPTER IV RIGHTS OF DATA SUBJECTS AND SUPERVISION Article 18 Information to data subjects and transparency 1. IMI actors shall ensure that data subjects are informed about processing of their personal data in IMI as soon as possible and that they have access to information on their rights and how to exercise them, including the identity and contact details of the controller and of the controller’s representative, if any, in accordance with Article 10 or 11 of Directive 95/46/EC and national legislation which is in accordance with that Directive. 2. The Commission shall make publicly available in a way which is easily accessible: (a) information concerning IMI in accordance with Articles 11 and 12 of Regulation (EC) No 45/2001, in a clear and understandable form; (b) information on the data protection aspects of administrative cooperation procedures in IMI as referred to in Article 11 of this Regulation; (c) information on exceptions to or limitations of the rights of data subjects as referred to in Article 20 of this Regulation; (d) types of administrative cooperation procedures, essential IMI functionalities and categories of data that may be processed in IMI; (e) a comprehensive list of all implementing or delegated acts regarding IMI, adopted pursuant to this Regulation or to another Union act, and a consolidated version of the Annex to this Regulation and its subsequent amendments by other Union acts. Article 19 Right of access, correction and deletion 1. IMI actors shall ensure that data subjects may effectively exercise their right of access to data relating to them in IMI, and the right to have inaccurate or incomplete data corrected and unlawfully processed data deleted, in accordance with national legislation. The correction or deletion of data shall be carried out as soon as possible, and at the latest 30 days after the request by the data subject is received by the IMI actor responsible. 2. Where the accuracy or lawfulness of data blocked pursuant to Article 14(1) is contested by the data subject, this fact shall be recorded, as well as the accurate, corrected information. Article 20 Exceptions and limitations Member States shall inform the Commission where they provide for exceptions to, or limitations of, the rights of data subjects set out in this Chapter in national legislation in accordance with Article 13 of Directive 95/46/EC. Article 21 Supervision 1. The national supervisory authority or authorities designated in each Member State and endowed with the powers referred to in Article 28 of Directive 95/46/EC (the ‘National Supervisory Authority’) shall independently monitor the lawfulness of the processing of personal data by the IMI actors of their Member State and, in particular, shall ensure that the rights of data subjects set out in this Chapter are protected in accordance with this Regulation. 2. The European Data Protection Supervisor shall monitor and seek to ensure that the personal data processing activities of the Commission, in its role as an IMI actor, are carried out in accordance with this Regulation. The duties and powers referred to in Articles 46 and 47 of Regulation (EC) No 45/2001 shall apply accordingly. 3. The National Supervisory Authorities and the European Data Protection Supervisor, each acting within the scope of their respective competencies, shall ensure coordinated supervision of IMI and its use by IMI actors. 4. The European Data Protection Supervisor may invite the National Supervisory Authorities to meet, where necessary, for the purposes of ensuring coordinated supervision of IMI and its use by IMI actors, as referred to in paragraph 3. The cost of such meetings shall be borne by the European Data Protection Supervisor. Further working methods for this purpose, including rules of procedure, may be developed jointly as necessary. A joint report of activities shall be sent to the European Parliament, the Council and the Commission at least every three years. CHAPTER V GEOGRAPHIC SCOPE OF IMI Article 22 National use of IMI 1. A Member State may use IMI for the purpose of administrative cooperation between competent authorities within its territory, in accordance with national law, only where the following conditions are satisfied: (a) no substantial changes to the existing administrative cooperation procedures are required; (b) a notification of the envisaged use of IMI has been submitted to the National Supervisory Authority where required under national law; and (c) it does not have a negative impact on the efficient functioning of IMI for IMI users. 2. Where a Member State intends to make systematic use of IMI for national purposes, it shall notify its intention to the Commission and seek its prior approval. The Commission shall examine whether the conditions set out in paragraph 1 are met. Where necessary, and in accordance with this Regulation, an agreement setting out, inter alia, the technical, financial and organisational arrangements for national use, including the responsibilities of the IMI actors, shall be concluded between the Member State and the Commission. Article 23 Information exchange with third countries 1. Information, including personal data, may be exchanged in IMI pursuant to this Regulation between IMI actors within the Union and their counterparts in a third country only where the following conditions are satisfied: (a) the information is processed pursuant to a provision of a Union act listed in the Annex and an equivalent provision in the law of the third country; (b) the information is exchanged or made available in accordance with an international agreement providing for: (i) the application of a provision of a Union act listed in the Annex by the third country; (ii) the use of IMI; and (iii) the principles and modalities of that exchange; and (c) the third country in question ensures adequate protection of personal data in accordance with Article 25(2) of Directive 95/46/EC, including adequate safeguards that the data processed in IMI shall only be used for the purpose for which they were initially exchanged, and the Commission has adopted a decision in accordance with Article 25(6) of Directive 95/46/EC. 2. Where the Commission is an IMI actor, Article 9(1) and (7) of Regulation (EC) No 45/2001 shall apply to any exchange of personal data processed in IMI with its counterparts in a third country. 3. The Commission shall publish in the Official Journal of the European Union and keep up-to-date a list of third countries authorised to exchange information, including personal data, in accordance with paragraph 1. CHAPTER VI FINAL PROVISIONS Article 24 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 25 Monitoring and reporting 1. The Commission shall report to the European Parliament and the Council on the functioning of IMI on a yearly basis. 2. By 5 December 2017 and every five years thereafter, the Commission shall report to the European Data Protection Supervisor on aspects relating to the protection of personal data in IMI, including data security. 3. For the purpose of producing the reports referred to in paragraphs 1 and 2, Member States shall provide the Commission with any information relevant to the application of this Regulation, including on the application in practice of the data protection requirements laid down in this Regulation. Article 26 Costs 1. The costs incurred for the development, promotion, operation and maintenance of IMI shall be borne by the general budget of the European Union, without prejudice to arrangements under Article 22(2). 2. Unless otherwise stipulated in a Union act, the costs for the IMI operations at Member State level, including the human resources needed for training, promotion and technical assistance (helpdesk) activities, as well as for the administration of IMI at national level, shall be borne by each Member State. Article 27 Repeal Decision 2008/49/EC is repealed. Article 28 Effective application Member States shall take all necessary measures to ensure effective application of this Regulation by their IMI actors. Article 29 Exceptions 1. Notwithstanding Article 4 of this Regulation, the IMI pilot project launched on 16 May 2011 to test the suitability of IMI for the implementation of Article 4 of Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services (12) may continue to operate on the basis of the arrangements that were made prior to the entry into force of this Regulation. 2. Notwithstanding Article 8(3) and points (a) and (b) of the first paragraph of Article 12 of this Regulation, for the implementation of the administrative cooperation provisions of the SOLVIT Recommendation through IMI, the involvement of the Commission in administrative cooperation procedures and the existing facility for external actors may continue on the basis of the arrangements that were made prior to the entry into force of this Regulation. The period as referred to in Article 14(1) of this Regulation shall be 18 months for personal data processed in IMI for the purposes of the SOLVIT Recommendation. 3. Notwithstanding Article 4(1) of this Regulation, the Commission may launch a pilot project to assess whether IMI is an efficient, cost-effective and user-friendly tool to implement Article 3(4), (5) and (6) of Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (13). No later than two years after the launch of that pilot project, the Commission shall submit to the European Parliament and the Council the evaluation referred to in Article 4(2) of this Regulation, which shall also cover the interaction between administrative cooperation within the consumer protection cooperation system established in accordance with Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws (the Regulation on consumer protection cooperation) (14) and within IMI. 4. Notwithstanding Article 14(1) of this Regulation, any periods up to a maximum of 18 months decided on the basis of Article 36 of Directive 2006/123/EC with regard to administrative cooperation pursuant to Chapter VI thereof shall continue to apply in that area. Article 30 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 25 October 2012. For the European Parliament The President M. SCHULZ For the Council The President A. D. MAVROYIANNIS (1) OJ C 43, 15.2.2012, p. 14. (2) Position of the European Parliament of 11 September 2012 (not yet published in the Official Journal) and decision of the Council of 4 October 2012. (3) OJ L 281, 23.11.1995, p. 31. (4) OJ L 8, 12.1.2001, p. 1. (5) OJ L 331, 15.12.2001, p. 79. (6) OJ L 376, 27.12.2006, p. 36. (7) OJ L 204, 21.7.1998, p. 37. (8) OJ L 13, 16.1.2008, p. 18. (9) OJ L 263, 7.10.2009, p. 32. (10) OJ L 55, 28.2.2011, p. 13. (11) OJ C 48, 18.2.2012, p. 2. (12) OJ L 18, 21.1.1997, p. 1. (13) OJ L 178, 17.7.2000, p. 1. (14) OJ L 364, 9.12.2004, p. 1. ANNEX PROVISIONS ON ADMINISTRATIVE COOPERATION IN UNION ACTS THAT ARE IMPLEMENTED BY MEANS OF IMI, REFERRED TO IN ARTICLE 3 1. Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (1): Chapter VI, Article 39(5), as well as Article 15(7), unless a notification, as provided for in that latter Article, is made in accordance with Directive 98/34/EC. 2. Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (2): Article 8, Article 50(1), (2) and (3), and Article 56. 3. Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (3): Article 10(4). 4. Regulation (EU) No 1214/2011 of the European Parliament and of the Council of 16 November 2011 on the professional cross-border transport of euro cash by road between euro-area Member States (4): Article 11(2). 5. Commission Recommendation of 7 December 2001 on principles for using ‘SOLVIT’ — the Internal Market Problem Solving Network (5): Chapters I and II. (1) OJ L 376, 27.12.2006, p. 36. (2) OJ L 255, 30.9.2005, p. 22. (3) OJ L 88, 4.4.2011, p. 45. (4) OJ L 316, 29.11.2011, p. 1. (5) OJ L 331, 15.12.2001, p. 79.

The EU’s Internal Market Information System (IMI) The EU’s Internal Market Information System (IMI) SUMMARY OF: Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information System WHAT IS THE AIM OF THE REGULATION? It lays down rules on the use of the Internal Market Information (IMI) system for administrative cooperation between EU countries’ competent authorities in Single Market related policy areas. KEY POINTS The IMI system is a secure Internet application that allows national, regional and local authorities to communicate quickly and easily with their counterparts in the EU, Iceland, Liechtenstein and Norway about EU internal market law (i.e. the laws relating to the single market that exists between the EU countries and in which the free movement of goods, services, capital and persons is assured, and where citizens are free to live, work, study and do business). It helps these authorities to overcome practical difficulties related in particular to differences in administrative culture, the use of different languages and the identification of partners in other EU countries. It is a free public service, developed by the Commission available in all EU languages and running since 2008. Major benefits for the publicBy speeding up procedures and improving the communication between public authorities, IMI reduces costs caused by delays and enables authorities to provide a better service to individuals and businesses. As such, IMI is a tool that indirectly helps individuals and businesses to make the most of the opportunities offered by the EU's internal market. Areas where the IMI is used Two examples of directives for which the IMI is used are Directive 2005/36/EC on the recognition of professional qualifications and Directive 2006/123/EC on services in the internal market. Under professional qualifications, the IMI system can be used by an EU country to check the validity of qualifications for professionals wanting to practise in that country. In addition to professional qualifications and services, the following are examples of other areas covered by the IMI: posting of workers: IMI supports the cooperation under the Posting of Workers and the Enforcement directives allowing EU countries to exchange information in the field of labour mobility,Consumer Protection Cooperation (CPC) Network: IMI supports 11 administrative procedures under the new CPC Regulation, helping consumer protection authorities and other stakeholders to cooperate in an efficient and user-friendly way (see summary),cross-border healthcare,Solvit (to which individuals and businesses can submit complaints about national authorities). Thanks to its flexibility, the system can easily be expanded to new areas. A list of areas in which IMI is used is available online. Main functions IMI offers the following main functions: bilateral information exchanges (one-to-one workflow) secure exchanges of information between two competent authorities; multilateral information exchanges (one-to-many workflows) allowing authorities to send out information to multiple recipients; repositories searchable multilingual databases to share information among IMI actors; SOLVIT case handling workflow to support the resolution of complaints from citizens and businesses concerning the application of EU law by public authorities; a public interface, allowing external actors to interact with IMI. Amendments to Regulation (EU) No 1024/2012 Regulation (EU) No 1024/2012 has been amended to enable IMI to be used in the context of: processing applications for a European professional card (Directive 2013/55/EU amending Directive 2005/36/EC — see summary); the posting of workers providing services (Directive 2014/67/EU — see summary); the return of cultural objects unlawfully removed from the territory of an EU country (Directive 2014/60/EU — see summary); the requirements for presenting certain public documents (Regulation (EU) 2016/1191 — see summary); EU type-approvals for non-road mobile machinery (Regulation (EU) 2016/1628 — see summary); the single digital gateway which allows online access to procedures and assistance for individuals and businesses (Regulation (EU) 2018/1724 — see summary); and the posting of drivers in the road transport sector (Directive (EU) 2020/1057). Regulation (EU) 2020/1055 amends the annex to Regulation (EU) No 1024/2012, adding Regulation (EC) No 1071/2009 on operating rules for road haulage and passenger transport companies (see summary) to the list of EU acts implemented by means of IMI. Implementing acts The Commission has adopted the following implementing acts: Implementing Decision 2014/89/EU on a pilot project concerning train driving licences (implementing Directive 2007/59/EC — see summary) Implementing Decision (EU) 2018/743 on a pilot project to implement the administrative cooperation rules relating to Regulation (EU) 2016/679 on the protection of personal data — see summary; Implementing Decision (EU) 2019/1253 on a pilot project to implement the administrative cooperation rules set out in Decision 2001/470/EC setting up a European Judicial Network in civil and commercial matters — see summary; Implementing Decision (EU) 2019/2212 on a pilot project to implement the administrative cooperation rules set out in Regulation (EU) 2017/2394 — see summary. FROM WHEN DOES THE REGULATION APPLY? Regulation (EU) No 1024/2012 has applied since 4 December 2012. BACKGROUND For more information, see: Internal Market Information System (European Commission). MAIN DOCUMENTS Regulation (EU) No 1024/2012 of the European Parliament and of the Council of 25 October 2012 on administrative cooperation through the Internal Market Information System and repealing Commission Decision 2008/49/EC (‘the IMI Regulation’) (OJ L 316, 14.11.2012, pp. 1-11) Successive amendments to Regulation (EU) No 1024/2012 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2020/1055 of the European Parliament and of the Council of 15 July 2020 amending Regulations (EC) No 1071/2009, (EC) No 1072/2009 and (EU) No 1024/2012 with a view to adapting them to developments in the road transport sector (OJ L 249, 31.7.2020, pp. 17-32) Directive (EU) 2020/1057 of the European Parliament and of the Council of 15 July 2020 laying down specific rules with respect to Directive 96/71/EC and Directive 2014/67/EU for posting drivers in the road transport sector and amending Directive 2006/22/EC as regards enforcement requirements and Regulation (EU) No 1024/2012 (OJ L 249, 31.7.2020, pp. 49-65) Commission Implementing Decision (EU) 2019/2212 of 20 December 2019 on a pilot project to implement certain administrative cooperation provisions set out in Regulation (EU) 2017/2394 of the European Parliament and of the Council on cooperation between authorities responsible for the enforcement of consumer protection laws by means of the Internal Market Information System (OJ L 332, 23.12.2019, pp. 159-162) Commission Implementing Decision (EU) 2019/1253 of 22 July 2019 on a pilot project to implement the administrative cooperation provisions set out in Council Decision 2001/470/EC establishing a European Judicial Network in civil and commercial matters by means of the Internal Market Information System (OJ L 195, 23.7.2019, pp. 40-42) Commission Implementing Decision (EU) 2018/743 of 16 May 2018 on a pilot project to implement the administrative cooperation provisions set out in Regulation (EU) 2016/679 of the European Parliament and of the Council by means of the Internal Market Information System (OJ L 123, 18.5.2018, pp. 115-118) Commission Implementing Decision 2014/89/EU of 14 February 2014 on a pilot project to implement the administrative cooperation obligations set out in Directive 2007/59/EC of the European Parliament and of the Council by means of the Internal Market Information System (OJ L 45, 15.2.2014, pp. 36-39) last update 16.10.2020

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28.2.2011 EN Official Journal of the European Union L 55/1 REGULATION (EU) No 181/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 February 2011 concerning the rights of passengers in bus and coach transport and amending Regulation (EC) No 2006/2004 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91(1) thereof, Having regard to the proposal from the European Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure, in the light of the joint text approved by the Conciliation Committee on 24 January 2011 (2), Whereas: (1) Action by the Union in the field of bus and coach transport should aim, among other things, at ensuring a high level of protection for passengers, that is comparable with other modes of transport, wherever they travel. Moreover, full account should be taken of the requirements of consumer protection in general. (2) Since the bus or coach passenger is the weaker party to the transport contract, all passengers should be granted a minimum level of protection. (3) Union measures to improve passengers’ rights in the bus and coach transport sector should take account of the specific characteristics of this sector, which consists largely of small- and medium-sized undertakings. (4) Passengers and, as a minimum, persons whom the passenger had, or would have had, a legal duty to maintain should enjoy adequate protection in the event of accidents arising out of the use of the bus or coach, taking into account Directive 2009/103/EC of the European Parliament and of the Council of 16 September 2009 relating to insurance against civil liability in respect of the use of motor vehicles and the enforcement of the obligation to insure against such liability (3). (5) In choosing the national law applicable to compensation for death, including reasonable funeral expenses, or personal injury as well as for loss of or damage to luggage due to accidents arising out of the use of the bus or coach, Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II) (4) and Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) (5) should be taken into account. (6) Passengers should, in addition to compensation in accordance with applicable national law in the event of death or personal injury or loss of or damage to luggage due to accidents arising out of the use of the bus or coach, be entitled to assistance with regard to their immediate practical needs following an accident. Such assistance should include, where necessary, first aid, accommodation, food, clothes and transport. (7) Bus and coach passenger services should benefit citizens in general. Consequently, disabled persons and persons with reduced mobility, whether caused by disability, age or any other factor, should have opportunities for using bus and coach services that are comparable to those of other citizens. Disabled persons and persons with reduced mobility have the same rights as all other citizens with regard to free movement, freedom of choice and non-discrimination. (8) In the light of Article 9 of the United Nations Convention on the Rights of Persons with Disabilities and in order to give disabled persons and persons with reduced mobility opportunities for bus and coach travel comparable to those of other citizens, rules for non-discrimination and assistance during their journey should be established. Those persons should therefore be accepted for carriage and not refused transport on the grounds of their disability or reduced mobility, except for reasons which are justified on the grounds of safety or of the design of vehicles or infrastructure. Within the framework of relevant legislation for the protection of workers, disabled persons and persons with reduced mobility should enjoy the right to assistance at terminals and on board vehicles. In the interest of social inclusion, the persons concerned should receive the assistance free of charge. Carriers should establish access conditions, preferably using the European standardisation system. (9) In deciding on the design of new terminals, and as part of major refurbishments, terminal managing bodies should endeavour to take into account the needs of disabled persons and persons with reduced mobility, in accordance with ‘design for all’ requirements. In any case, terminal managing bodies should designate points where such persons can notify their arrival and need for assistance. (10) Similarly, without prejudice to current or future legislation on technical requirements for buses and coaches, carriers should, where possible, take those needs into account when deciding on the equipment of new and newly refurbished vehicles. (11) Member States should endeavour to improve existing infrastructure where this is necessary to enable carriers to ensure access for disabled persons and persons with reduced mobility as well as to provide appropriate assistance. (12) In order to respond to the needs of disabled persons and persons with reduced mobility, staff should be adequately trained. With a view to facilitating the mutual recognition of national qualifications of drivers, disability awareness training could be provided as a part of the initial qualification or periodic training as referred to in Directive 2003/59/EC of the European Parliament and of the Council of 15 July 2003 on the initial qualification and periodic training of drivers of certain road vehicles for the carriage of goods or passengers (6). In order to ensure coherence between the introduction of the training requirements and the time-limits set out in that Directive, a possibility for exemption during a limited period of time should be allowed. (13) Organisations representative of disabled persons or persons with reduced mobility should be consulted or involved in preparing the content of the disability-related training. (14) Rights of bus and coach passengers should include the receipt of information regarding the service before and during the journey. All essential information provided to bus and coach passengers should also be provided, upon request, in alternative formats accessible to disabled persons and persons with reduced mobility, such as large print, plain language, Braille, electronic communications that can be accessed with adaptive technology, or audio tapes. (15) This Regulation should not restrict the rights of carriers to seek compensation from any person, including third parties, in accordance with the applicable national law. (16) Inconvenience experienced by passengers due to cancellation or significant delay of their journey should be reduced. To this end, passengers departing from terminals should be adequately looked after and informed in a way which is accessible to all passengers. Passengers should also be able to cancel their journey and have their tickets reimbursed or to continue their journey or to obtain re-routing under satisfactory conditions. If carriers fail to provide passengers with the necessary assistance, passengers should have the right to obtain financial compensation. (17) With the involvement of stakeholders, professional associations and associations of customers, passengers, disabled persons and persons with reduced mobility, carriers should cooperate in order to adopt arrangements at national or European level. Such arrangements should aim at improving the information, care and assistance offered to passengers whenever their travel is interrupted, in particular in the event of long delays or cancellation of travel, with a particular focus on passengers with special needs due to disability, reduced mobility, illness, elderly age and pregnancy, and including accompanying passengers and passengers travelling with young children. National enforcement bodies should be informed of those arrangements. (18) This Regulation should not affect the rights of passengers established by Council Directive 90/314/EEC of 13 June 1990 on package travel, package holidays and package tours (7). This Regulation should not apply in cases where a package tour is cancelled for reasons other than cancellation of the bus or coach transport service. (19) Passengers should be fully informed of their rights under this Regulation, so that they can effectively exercise those rights. (20) Passengers should be able to exercise their rights by means of appropriate complaint procedures implemented by carriers or, as the case may be, by submission of complaints to the body or bodies designated to that end by the relevant Member State. (21) Member States should ensure compliance with this Regulation and designate a competent body or bodies to carry out supervision and enforcement tasks. This does not affect the rights of passengers to seek legal redress from courts under national law. (22) Taking into account the procedures established by Member States for the submission of complaints, a complaint concerning assistance should preferably be addressed to the body or bodies designated for the enforcement of this Regulation in the Member State where the boarding point or alighting point is situated. (23) Member States should promote the use of public transport and the use of integrated information and integrated tickets in order to optimise the use and interoperability of the various transport modes and operators. (24) Member States should lay down penalties applicable to infringements of this Regulation and ensure that those penalties are applied. Those penalties should be effective, proportionate and dissuasive. (25) Since the objective of this Regulation, namely to ensure an equivalent level of protection of and assistance to passengers in bus and coach transport throughout the Member States, cannot sufficiently be achieved by the Member States and can therefore by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (26) This Regulation should be without prejudice to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (8). (27) The enforcement of this Regulation should be based on Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection law (the Regulation on consumer protection cooperation) (9). That Regulation should therefore be amended accordingly. (28) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, as referred to in Article 6 of the Treaty on European Union, bearing in mind also Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin (10) and Council Directive 2004/113/EC of 13 December 2004 implementing the principle of equal treatment between men and women in the access to and supply of goods and services (11), HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes rules for bus and coach transport as regards the following: (a) non-discrimination between passengers with regard to transport conditions offered by carriers; (b) rights of passengers in the event of accidents arising out of the use of the bus or coach resulting in death or personal injury or loss of or damage to luggage; (c) non-discrimination and mandatory assistance for disabled persons and persons with reduced mobility; (d) rights of passengers in cases of cancellation or delay; (e) minimum information to be provided to passengers; (f) handling of complaints; (g) general rules on enforcement. Article 2 Scope 1. This Regulation shall apply to passengers travelling with regular services for non-specified categories of passengers where the boarding or the alighting point of the passengers is situated in the territory of a Member State and where the scheduled distance of the service is 250 km or more. 2. As regards the services referred to in paragraph 1 but where the scheduled distance of the service is shorter than 250 km, Article 4(2), Article 9, Article 10(1), point (b) of Article 16(1), Article 16(2), Article 17(1) and (2), and Articles 24 to 28 shall apply. 3. In addition, with the exception of Articles 9 to 16, Article 17(3), and Chapters IV, V and VI, this Regulation shall apply to passengers travelling with occasional services where the initial boarding point or the final alighting point of the passenger is situated in the territory of a Member State. 4. With the exception of Article 4(2), Article 9, Article 10(1), point (b) of Article 16(1), Article 16(2), Article 17(1) and (2), and Articles 24 to 28, Member States may, on a transparent and non-discriminatory basis, exempt domestic regular services from the application of this Regulation. Such exemptions may be granted as from the date of application of this Regulation for a period no longer than 4 years, which may be renewed once. 5. For a maximum period of 4 years from the date of application of this Regulation, Member States may, on a transparent and non-discriminatory basis, exempt from the application of this Regulation particular regular services because a significant part of such regular services, including at least one scheduled stop, is operated outside the Union. Such exemptions may be renewed once. 6. Member States shall inform the Commission of exemptions of different types of services granted pursuant to paragraphs 4 and 5. The Commission shall take appropriate action if such an exemption is deemed not to be in accordance with the provisions of this Article. By 2 March 2018, the Commission shall submit to the European Parliament and the Council a report on exemptions granted pursuant to paragraphs 4 and 5. 7. Nothing in this Regulation shall be understood as conflicting with or introducing additional requirements to those in current legislation on technical requirements for buses or coaches or infrastructure or equipment at bus stops and terminals. 8. This Regulation shall not affect the rights of passengers under Directive 90/314/EEC and shall not apply in case where a package tour referred to in that Directive is cancelled for reasons other than cancellation of a regular service. Article 3 Definitions For the purposes of this Regulation, the following definitions shall apply: (a) ‘regular services’ means services which provide for the carriage of passengers by bus or coach at specified intervals along specified routes, passengers being picked up and set down at predetermined stopping points; (b) ‘occasional services’ means services which do not fall within the definition of regular services and the main characteristic of which is the carriage by bus or coach of groups of passengers constituted on the initiative of the customer or the carrier himself; (c) ‘transport contract’ means a contract of carriage between a carrier and a passenger for the provision of one or more regular or occasional services; (d) ‘ticket’ means a valid document or other evidence of a transport contract; (e) ‘carrier’ means a natural or legal person, other than a tour operator, travel agent or ticket vendor, offering transport by regular or occasional services to the general public; (f) ‘performing carrier’ means a natural or legal person other than the carrier, who actually performs the carriage wholly or partially; (g) ‘ticket vendor’ means any intermediary concluding transport contracts on behalf of a carrier; (h) ‘travel agent’ means any intermediary acting on behalf of a passenger for the conclusion of transport contracts; (i) ‘tour operator’ means an organiser or retailer, other than the carrier, within the meaning of Article 2(2) and (3) of Directive 90/314/EEC; (j) ‘disabled person’ or ‘person with reduced mobility’ means any person whose mobility when using transport is reduced as a result of any physical disability (sensory or locomotory, permanent or temporary), intellectual disability or impairment, or any other cause of disability, or as a result of age, and whose situation needs appropriate attention and adaptation to his particular needs of the services made available to all passengers; (k) ‘access conditions’ means relevant standards, guidelines and information on the accessibility of buses and/or of designated terminals including their facilities for disabled persons or persons with reduced mobility; (l) ‘reservation’ means a booking of a seat on board a bus or coach for a regular service at a specific departure time; (m) ‘terminal’ means a staffed terminal where according to the specified route a regular service is scheduled to stop for passengers to board or alight, equipped with facilities such as a check-in counter, waiting room or ticket office; (n) ‘bus stop’ means any point other than a terminal where according to the specified route a regular service is scheduled to stop for passengers to board or alight; (o) ‘terminal managing body’ means an organisational entity in a Member State responsible for the management of a designated terminal; (p) ‘cancellation’ means the non-operation of a regular service which was previously scheduled; (q) ‘delay’ means a difference between the time the regular service was scheduled to depart in accordance with the published timetable and the time of its actual departure. Article 4 Tickets and non-discriminatory contract conditions 1. Carriers shall issue a ticket to the passenger, unless other documents give entitlement to transport. A ticket may be issued in an electronic format. 2. Without prejudice to social tariffs, the contract conditions and tariffs applied by carriers shall be offered to the general public without any direct or indirect discrimination based on the nationality of the final customer or on the place of establishment of the carriers, or ticket vendors within the Union. Article 5 Other performing parties 1. If the performance of the obligations under this Regulation has been entrusted to a performing carrier, ticket vendor or any other person, the carrier, travel agent, tour operator or terminal managing body, who has entrusted such obligations, shall nevertheless be liable for the acts and omissions of that performing party. 2. In addition, the party to whom the performance of an obligation has been entrusted by the carrier, travel agent, tour operator or terminal managing body shall be subject to the provisions of this Regulation with regard to the obligation entrusted. Article 6 Exclusion of waiver 1. Obligations to passengers pursuant to this Regulation shall not be limited or waived, in particular by a derogation or restrictive clause in the transport contract. 2. Carriers may offer contract conditions that are more favourable for the passenger than the conditions laid down in this Regulation. CHAPTER II COMPENSATION AND ASSISTANCE IN THE EVENT OF ACCIDENTS Article 7 Death or personal injury to passengers and loss of or damage to luggage 1. Passengers shall, in accordance with applicable national law, be entitled to compensation for death, including reasonable funeral expenses, or personal injury as well as to loss of or damage to luggage due to accidents arising out of the use of the bus or coach. In case of death of a passenger, this right shall as a minimum apply to persons whom the passenger had, or would have had, a legal duty to maintain. 2. The amount of compensation shall be calculated in accordance with applicable national law. Any maximum limit provided by national law to the compensation for death and personal injury or loss of or damage to luggage shall on each distinct occasion not be less than: (a) EUR 220 000 per passenger; (b) EUR 1 200 per item of luggage. In the event of damage to wheelchairs, other mobility equipment or assistive devices the amount of compensation shall always be equal to the cost of replacement or repair of the equipment lost or damaged. Article 8 Immediate practical needs of passengers In the event of an accident arising out of the use of the bus or coach, the carrier shall provide reasonable and proportionate assistance with regard to the passengers’ immediate practical needs following the accident. Such assistance shall include, where necessary, accommodation, food, clothes, transport and the facilitation of first aid. Any assistance provided shall not constitute recognition of liability. For each passenger, the carrier may limit the total cost of accommodation to EUR 80 per night and for a maximum of 2 nights. CHAPTER III RIGHTS OF DISABLED PERSONS AND PERSONS WITH REDUCED MOBILITY Article 9 Right to transport 1. Carriers, travel agents and tour operators shall not refuse to accept a reservation from, to issue or otherwise provide a ticket to, or to take on board, a person on the grounds of disability or of reduced mobility. 2. Reservations and tickets shall be offered to disabled persons and persons with reduced mobility at no additional cost. Article 10 Exceptions and special conditions 1. Notwithstanding Article 9(1), carriers, travel agents and tour operators may refuse to accept a reservation from, to issue or otherwise provide a ticket to, or to take on board, a person on the grounds of disability or of reduced mobility: (a) in order to meet applicable safety requirements established by international, Union or national law, or in order to meet health and safety requirements established by the competent authorities; (b) where the design of the vehicle or the infrastructure, including bus stops and terminals, makes it physically impossible to take on board, alight or carry the disabled person or person with reduced mobility in a safe and operationally feasible manner. 2. In the event of a refusal to accept a reservation or to issue or otherwise provide a ticket on the grounds referred to in paragraph 1, carriers, travel agents and tour operators shall inform the person concerned about any acceptable alternative service operated by the carrier. 3. If a disabled person or a person with reduced mobility, who holds a reservation or has a ticket and has complied with the requirements of point (a) of Article 14(1), is nonetheless refused permission to board on the grounds of his disability or reduced mobility, that person and any accompanying person pursuant to paragraph 4 of this Article shall be offered the choice between: (a) the right to reimbursement, and where relevant a return service free of charge to the first point of departure, as set out in the transport contract, at the earliest opportunity; and (b) except where not feasible, continuation of the journey or re-routing by reasonable alternative transport services to the place of destination set out in the transport contract. The right to reimbursement of the money paid for the ticket shall not be affected by the failure to notify in accordance with point (a) of Article 14(1). 4. If a carrier, travel agent or tour operator refuses to accept a reservation from, to issue or otherwise provide a ticket to, or to take on board, a person on the grounds of disability or of reduced mobility for the reasons set out in paragraph 1, that person may request to be accompanied by another person of his own choosing who is capable of providing the assistance required by the disabled person or person with reduced mobility in order that the reasons set out in paragraph 1 no longer apply. Such an accompanying person shall be transported free of charge and, where feasible, seated next to the disabled person or person with reduced mobility. 5. When carriers, travel agents or tour operators have recourse to paragraph 1, they shall immediately inform the disabled person or person with reduced mobility of the reasons therefor, and, upon request, inform the person in question in writing within 5 working days of the request. Article 11 Accessibility and information 1. In cooperation with organisations representative of disabled persons or persons with reduced mobility, carriers and terminal managing bodies shall, where appropriate through their organisations, establish, or have in place, non-discriminatory access conditions for the transport of disabled persons and persons with reduced mobility. 2. The access conditions provided for in paragraph 1, including the text of international, Union or national laws establishing the safety requirements, on which these non-discriminatory access conditions are based, shall be made publicly available by carriers and terminal managing bodies physically or on the Internet, in accessible formats on request, in the same languages as those in which information is generally made available to all passengers. When providing this information particular attention shall be paid to the needs of disabled persons and persons with reduced mobility. 3. Tour operators shall make available the access conditions provided for in paragraph 1 which apply to journeys included in package travel, package holidays and package tours which they organise, sell or offer for sale. 4. The information on access conditions referred to in paragraphs 2 and 3 shall be physically distributed at the request of the passenger. 5. Carriers, travel agents and tour operators shall ensure that all relevant general information concerning the journey and the conditions of carriage is available in appropriate and accessible formats for disabled persons and persons with reduced mobility including, where applicable, online booking and information. The information shall be physically distributed at the request of the passenger. Article 12 Designation of terminals Member States shall designate bus and coach terminals where assistance for disabled persons and persons with reduced mobility shall be provided. Member States shall inform the Commission thereof. The Commission shall make available a list of the designated bus and coach terminals on the Internet. Article 13 Right to assistance at designated terminals and on board buses and coaches 1. Subject to the access conditions provided for in Article 11(1), carriers and terminal managing bodies shall, within their respective areas of competence, at terminals designated by Member States, provide assistance free of charge to disabled persons and persons with reduced mobility, at least to the extent specified in part (a) of Annex I. 2. Subject to the access conditions provided for in Article 11(1), carriers shall, on board buses and coaches, provide assistance free of charge to disabled persons and persons with reduced mobility, at least to the extent specified in part (b) of Annex I. Article 14 Conditions under which assistance is provided 1. Carriers and terminal managing bodies shall cooperate in order to provide assistance to disabled persons and persons with reduced mobility on condition that: (a) the person’s need for such assistance is notified to carriers, terminal managing bodies, travel agents or tour operators at the latest 36 hours before the assistance is needed; and (b) the persons concerned present themselves at the designated point: (i) at the time stipulated in advance by the carrier which shall be no more than 60 minutes before the published departure time, unless a shorter period is agreed between the carrier and the passenger; or (ii) if no time is stipulated, no later than 30 minutes before the published departure time. 2. In addition to paragraph 1, disabled persons or persons with reduced mobility shall notify the carrier, travel agent or tour operator at the time of reservation or advance purchase of the ticket of their specific seating needs, provided that the need is known at that time. 3. Carriers, terminal managing bodies, travel agents and tour operators shall take all measures necessary to facilitate the receipt of notifications of the need for assistance made by disabled persons or persons with reduced mobility. This obligation shall apply at all designated terminals and their points of sale including sale by telephone and via the Internet. 4. If no notification is made in accordance with point (a) of paragraph 1 and paragraph 2, carriers, terminal managing bodies, travel agents and tour operators shall make every reasonable effort to ensure that the assistance is provided in such a way that the disabled person or person with reduced mobility is able to board the departing service, to change to the corresponding service or to alight from the arriving service for which he has purchased a ticket. 5. The terminal managing body shall designate a point inside or outside the terminal at which disabled persons or persons with reduced mobility can announce their arrival and request assistance. The point shall be clearly signposted and shall offer basic information about the terminal and assistance provided, in accessible formats. Article 15 Transmission of information to a third party If travel agents or tour operators receive a notification referred to in point (a) of Article 14(1) they shall, within their normal office hours, transfer the information to the carrier or terminal managing body as soon as possible. Article 16 Training 1. Carriers and, where appropriate, terminal managing bodies shall establish disability-related training procedures, including instructions, and ensure that: (a) their personnel, other than drivers, including those employed by any other performing party, providing direct assistance to disabled persons and persons with reduced mobility are trained or instructed as described in parts (a) and (b) of Annex II; and (b) their personnel, including drivers, who deal directly with the travelling public or with issues related to the travelling public, are trained or instructed as described in part (a) of Annex II. 2. A Member State may for a maximum period of 5 years from 1 March 2013 grant an exemption from the application of point (b) of paragraph 1 with regard to training of drivers. Article 17 Compensation in respect of wheelchairs and other mobility equipment 1. Carriers and terminal managing bodies shall be liable where they have caused loss of or damage to wheelchairs, other mobility equipment or assistive devices. The loss or damage shall be compensated by the carrier or terminal managing body liable for that loss or damage. 2. The compensation referred to in paragraph 1 shall be equal to the cost of replacement or repair of the equipment or devices lost or damaged. 3. Where necessary, every effort shall be undertaken to rapidly provide temporary replacement equipment or devices. The wheelchairs, other mobility equipment or assistive devices shall, where possible, have technical and functional features similar to those lost or damaged. Article 18 Exemptions 1. Without prejudice to Article 2(2), Member States may exempt domestic regular services from the application of all or some of the provisions of this Chapter, provided that they ensure that the level of protection of disabled persons and persons with reduced mobility under their national rules is at least the same as under this Regulation. 2. Member States shall inform the Commission of exemptions granted pursuant to paragraph 1. The Commission shall take appropriate action if such an exemption is deemed not to be in accordance with the provisions of this Article. By 2 March 2018, the Commission shall submit to the European Parliament and the Council a report on exemptions granted pursuant to paragraph 1. CHAPTER IV PASSENGER RIGHTS IN THE EVENT OF CANCELLATION OR DELAY Article 19 Continuation, re-routing and reimbursement 1. Where a carrier reasonably expects a regular service to be cancelled or delayed in departure from a terminal for more than 120 minutes or in the case of overbooking, the passenger shall immediately be offered the choice between: (a) continuation or re-routing to the final destination, at no additional cost and under comparable conditions, as set out in the transport contract, at the earliest opportunity; (b) reimbursement of the ticket price, and, where relevant, a return service by bus or coach free of charge to the first point of departure, as set out in the transport contract, at the earliest opportunity. 2. If the carrier fails to offer the passenger the choice referred to in paragraph 1, the passenger shall have the right to compensation amounting to 50 % of the ticket price, in addition to the reimbursement referred to in point (b) of paragraph 1. This sum shall be paid by the carrier within 1 month after the submission of the request for compensation. 3. Where the bus or coach becomes inoperable during the journey, the carrier shall provide either the continuation of the service with another vehicle from the location of the inoperable vehicle, or transport from the location of the inoperable vehicle to a suitable waiting point or terminal from where continuation of the journey becomes possible. 4. Where a regular service is cancelled or delayed in departure from a bus stop for more than 120 minutes, passengers shall have the right to the continuation or re-routing or reimbursement of the ticket price from the carrier, as referred to in paragraph 1. 5. The payment of reimbursement provided for in point (b) of paragraph 1 and paragraph 4 shall be made within 14 days after the offer has been made or request has been received. The payment shall cover the full cost of the ticket at the price at which it was purchased, for the part or parts of the journey not made, and for the part or parts already made if the journey no longer serves any purpose in relation to the passenger’s original travel plan. In case of travel passes or season tickets the payment shall be equal to its proportional part of the full cost of the pass or ticket. The reimbursement shall be paid in money, unless the passenger accepts another form of reimbursement. Article 20 Information 1. In the event of cancellation or delay in departure of a regular service, passengers departing from terminals shall be informed by the carrier or, where appropriate, the terminal managing body, of the situation as soon as possible and in any event no later than 30 minutes after the scheduled departure time, and of the estimated departure time as soon as this information is available. 2. If passengers miss, according to the timetable, a connecting service due to a cancellation or delay, the carrier or, where appropriate, the terminal managing body, shall make reasonable efforts to inform the passengers concerned of alternative connections. 3. The carrier or, where appropriate, the terminal managing body, shall ensure that disabled persons and persons with reduced mobility receive the information required under paragraphs 1 and 2 in accessible formats. 4. Where feasible, the information required under paragraphs 1 and 2 shall be provided by electronic means to all passengers, including those departing from bus stops, within the time-limit stipulated in paragraph 1, if the passenger has requested this and has provided the necessary contact details to the carrier. Article 21 Assistance in case of cancelled or delayed departures For a journey of a scheduled duration of more than 3 hours the carrier shall, in case of cancellation or delay in departure from a terminal of more than 90 minutes, offer the passenger free of charge: (a) snacks, meals or refreshments in reasonable relation to the waiting time or delay, provided they are available on the bus or in the terminal, or can reasonably be supplied; (b) a hotel room or other accommodation as well as assistance to arrange transport between the terminal and the place of accommodation in cases where a stay of 1 or more nights becomes necessary. For each passenger, the carrier may limit the total cost of accommodation, not including transport to and from the terminal and place of accommodation, to EUR 80 per night and for a maximum of 2 nights. In applying this Article the carrier shall pay particular attention to the needs of disabled persons and persons with reduced mobility and any accompanying persons. Article 22 Further claims Nothing in this Chapter shall preclude passengers from seeking damages in accordance with national law before national courts in respect of loss resulting from cancellation or delay of regular services. Article 23 Exemptions 1. Articles 19 and 21 shall not apply to passengers with open tickets as long as the time of departure is not specified, except for passengers holding a travel pass or a season ticket. 2. Point (b) of Article 21 shall not apply where the carrier proves that the cancellation or delay is caused by severe weather conditions or major natural disasters endangering the safe operation of bus or coach services. CHAPTER V GENERAL RULES ON INFORMATION AND COMPLAINTS Article 24 Right to travel information Carriers and terminal managing bodies shall, within their respective areas of competence, provide passengers with adequate information throughout their travel. Where feasible, this information shall be provided in accessible formats upon request. Article 25 Information on passenger rights 1. Carriers and terminal managing bodies shall, within their respective areas of competence, ensure that passengers are provided with appropriate and comprehensible information regarding their rights under this Regulation at the latest on departure. This information shall be provided at terminals and where applicable, on the Internet. At the request of a disabled person or person with reduced mobility the information shall be provided, where feasible, in an accessible format. This information shall include contact details of the enforcement body or bodies designated by the Member State pursuant to Article 28(1). 2. In order to comply with the information requirement referred to in paragraph 1, carriers and terminal managing bodies may use a summary of the provisions of this Regulation prepared by the Commission in all the official languages of the institutions of the European Union and made available to them. Article 26 Complaints Carriers shall set up or have in place a complaint handling mechanism for the rights and obligations set out in this Regulation. Article 27 Submission of complaints Without prejudice to claims for compensation in accordance with Article 7, if a passenger covered by this Regulation wants to make a complaint to the carrier, he shall submit it within 3 months from the date on which the regular service was performed or when a regular service should have been performed. Within 1 month of receiving the complaint, the carrier shall give notice to the passenger that his complaint has been substantiated, rejected or is still being considered. The time taken to provide the final reply shall not be longer than 3 months from the receipt of the complaint. CHAPTER VI ENFORCEMENT AND NATIONAL ENFORCEMENT BODIES Article 28 National enforcement bodies 1. Each Member State shall designate a new or existing body or bodies responsible for the enforcement of this Regulation as regards regular services from points situated on its territory and regular services from a third country to such points. Each body shall take the measures necessary to ensure compliance with this Regulation. Each body shall, in its organisation, funding decisions, legal structure and decision making, be independent of carriers, tour operators and terminal managing bodies. 2. Member States shall inform the Commission of the body or bodies designated in accordance with this Article. 3. Any passenger may submit a complaint, in accordance with national law, to the appropriate body designated under paragraph 1, or to any other appropriate body designated by a Member State, about an alleged infringement of this Regulation. A Member State may decide that the passenger as a first step shall submit a complaint to the carrier in which case the national enforcement body or any other appropriate body designated by the Member State shall act as an appeal body for complaints not resolved under Article 27. Article 29 Report on enforcement By 1 June 2015 and every 2 years thereafter, the enforcement bodies designated pursuant to Article 28(1) shall publish a report on their activity in the previous 2 calendar years, containing in particular a description of actions taken in order to implement this Regulation and statistics on complaints and sanctions applied. Article 30 Cooperation between enforcement bodies National enforcement bodies as referred to in Article 28(1) shall, whenever appropriate, exchange information on their work and decision-making principles and practices. The Commission shall support them in this task. Article 31 Penalties Member States shall lay down rules on penalties applicable to infringements of the provisions of this Regulation and shall take all the measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall notify those rules and measures to the Commission by 1 March 2013 and shall notify it without delay of any subsequent amendment affecting them. CHAPTER VII FINAL PROVISIONS Article 32 Report The Commission shall report to the European Parliament and the Council by 2 March 2016 on the operation and effects of this Regulation. The report shall be accompanied, where necessary, by legislative proposals implementing in further detail the provisions of this Regulation, or amending it. Article 33 Amendment to Regulation (EC) No 2006/2004 In the Annex to Regulation (EC) No 2006/2004 the following point is added: ‘19. Regulation (EU) No 181/2011 of the European Parliament and of the Council of 16 February 2011 on the rights of passengers in bus and coach transport (12). Article 34 Entry into force This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 1 March 2013. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 16 February 2011. For the European Parliament The President J. BUZEK For the Council The President MARTONYI J. (1) OJ C 317, 23.12.2009, p. 99. (2) Position of the European Parliament of 23 April 2009 (OJ C 184 E, 8.7.2010, p. 312), position of the Council at first reading of 11 March 2010 (OJ C 122 E, 11.5.2010, p. 1), position of the European Parliament of 6 July 2010 (not yet published in the Official Journal), decision of the Council of 31 January 2011 and legislative resolution of the European Parliament of 15 February 2011 (not yet published in the Official Journal). (3) OJ L 263, 7.10.2009, p. 11. (4) OJ L 199, 31.7.2007, p. 40. (5) OJ L 177, 4.7.2008, p. 6. (6) OJ L 226, 10.9.2003, p. 4. (7) OJ L 158, 23.6.1990, p. 59. (8) OJ L 281, 23.11.1995, p. 31. (9) OJ L 364, 9.12.2004, p. 1. (10) OJ L 180, 19.7.2000, p. 22. (11) OJ L 373, 21.12.2004, p. 37. (12) OJ L 55, 28.2.2011, p. 1’. ANNEX I ASSISTANCE PROVIDED TO DISABLED PERSONS AND PERSONS WITH REDUCED MOBILITY (a) Assistance at designated terminals Assistance and arrangements necessary to enable disabled persons and persons with reduced mobility to: — communicate their arrival at the terminal and their request for assistance at designated points, — move from the designated point to the check-in counter, waiting room and embarkation area, — board the vehicle, with the provision of lifts, wheelchairs or other assistance needed, as appropriate, — load their luggage, — retrieve their luggage, — alight from the vehicle, — carry a recognised assistance dog on board a bus or coach, — proceed to the seat; (b) Assistance on board Assistance and arrangements necessary to enable disabled persons and persons with reduced mobility to: — be provided with essential information on a journey in accessible formats subject to request made by the passenger, — board/alight during pauses in a journey, if there are personnel other than the driver on board. ANNEX II DISABILITY-RELATED TRAINING (a) Disability-awareness training Training of staff that deal directly with the travelling public includes: — awareness of and appropriate responses to passengers with physical, sensory (hearing and visual), hidden or learning disabilities, including how to distinguish between the different abilities of persons whose mobility, orientation, or communication may be reduced, — barriers faced by disabled persons and persons with reduced mobility, including attitudinal, environmental/physical and organisational barriers, — recognised assistance dogs, including the role and the needs of an assistance dog, — dealing with unexpected occurrences, — interpersonal skills and methods of communication with deaf people and people with hearing impairments, people with visual impairments, people with speech impairments, and people with a learning disability, — how to handle wheelchairs and other mobility aids carefully so as to avoid damage (if any, for all staff who are responsible for luggage handling); (b) Disability-assistance training Training of staff directly assisting disabled persons and persons with reduced mobility includes: — how to help wheelchair users make transfers into and out of a wheelchair, — skills for providing assistance to disabled persons and persons with reduced mobility travelling with a recognised assistance dog, including the role and the needs of those dogs, — techniques for escorting visually impaired passengers and for the handling and carriage of recognised assistance dogs, — an understanding of the types of equipment which can assist disabled persons and persons with reduced mobility and a knowledge of how to handle such an equipment, — the use of boarding and alighting assistance equipment used and knowledge of the appropriate boarding and alighting assistance procedures that safeguard the safety and dignity of disabled persons and persons with reduced mobility, — understanding of the need for reliable and professional assistance. Also awareness of the potential of certain disabled passengers to experience feelings of vulnerability during travel because of their dependence on the assistance provided, — a knowledge of first aid.

Bus and coach passengers’ rights Bus and coach passengers’ rights Passengers, including those with a disability or reduced mobility, travelling by bus and coach enjoy the same rights wherever they travel in the European Union (EU). These rights, including the right to information or compensation in the case of delay or cancellation, complement similar rights for sea and inland waterway, air and rail passengers. ACT Regulation (EU) No 181/2011 of the European Parliament and of the Council of 16 February 2011 concerning the rights of passengers in bus and coach transport and amending Regulation (EC) No 2006/2004 SUMMARY Passengers, including those with a disability or reduced mobility, travelling by bus and coach enjoy the same rights wherever they travel in the European Union (EU). These rights, including the right to information or compensation in the case of delay or cancellation, complement similar rights for sea and inland waterway, air and rail passengers. WHAT DOES THIS REGULATION DO? The regulation sets down rules for bus and coach transport regarding regular services* for passengers travelling within the EU for distances of 250 kms or more. Some of its provisions apply to all services, including those of a shorter distance. KEY POINTS In respect of long-distance services, i.e. of more than 250 kms, the regulation provides: in situations of cancellation or following a delay of more than 90 minutes in the case of a journey of more than 3 hours, for adequate assistance e.g. snacks, meals and up to 2 nights’ hotel. accommodation; guarantee of reimbursement or rerouting in situations of overbooking or cancellation or following a delay of more than 120 minutes from the estimated time of departure; compensation of 50 % of the ticket price following more than 120 minutes’ delay from the estimated time of departure, cancellation of a journey and if the carrier fails to offer the passenger either rerouting or reimbursement; information when the service is cancelled or delayed in departure; protection of passengers in case of injury, loss or damage caused by road accidents and/or compensation in case of death; specific assistance free of charge for disabled persons and persons with reduced mobility both at terminals and on board and, where necessary, transport free of charge for accompanying people. Additionally, for distances of less than 250 kms, the regulation provides for: non-discrimination based on nationality with respect to prices and contract conditions for passengers; non-discriminatory treatment of disabled persons and persons with reduced mobility and financial compensation for loss or damage of their mobility equipment in case of accident; minimum rules on travel information for all passengers before and during their journey and general information about their rights in terminals and online; a complaint handling mechanism established by carriers and available to all passengers; independent national bodies in each EU country with the mandate to enforce the regulation and, where appropriate, to impose penalties. The regulation provides for the option of exemptions for domestic regular services and for regular services where a significant part is operated outside the EU. WHEN DOES THIS REGULATION APPLY? From 1 March 2013. BACKGROUND European Commission website on bus and coach passenger rights Following the COVID-19 outbreak and introducing measures to cope with the impact of the crisis, the European Commission adopted:Commission Notice Interpretative Guidelines on EU passenger rights regulations in the context of the developing situation with Covid-19Commission Recommendation (EU) 2020/648 of 13 May 2020 on vouchers offered to passengers and travellers as an alternative to reimbursement for cancelled package travel and transport services in the context of the COVID-19 pandemicKEY TERMS *regular services: ordinary bus and coach services carrying passengers along specified routes with pre-determined pick-up/stopping points. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 181/2011 20.3.2011 - OJ L 55, 28.2.2011, pp. 1-12 last update 02.06.2020

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20.12.2013 EN Official Journal of the European Union L 347/884 COUNCIL REGULATION (EU, EURATOM) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 312 thereof, Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a thereof, Having regard to the proposal from the European Commission, Having regard to the consent of the European Parliament, After transmission of the draft legislative act to national parliaments, Acting in accordance with a special legislative procedure, Whereas: (1) The annual ceilings on commitments appropriations by category of expenditure and the annual ceilings on payment appropriations established by this Regulation must respect the ceilings set for commitments and own resources in Council Decision 2007/436/EC,Euratom (1). (2) Taking into account the need for an adequate level of predictability for preparing and implementing medium-term investments, the duration of the multiannual financial framework (MFF) should be set at seven years starting on 1 January 2014. A review will take place in 2016 at the latest, following the European Parliament elections. This will allow the institutions, including the European Parliament elected in 2014, to reassess the priorities. The results of this review should be taken into account in any revision of this Regulation for the remaining years of the MFF. This arrangement is hereinafter referred to as "review/revision". (3) In the context of the mid-term review/revision of the MFF, the European Parliament, the Council and the Commission agree to jointly examine the most suitable duration for the subsequent MFF before the Commission presents its proposals with a view to striking the right balance between the duration of the respective terms of office of the members of the European Parliament and the European Commission - and the need for stability for programming cycles and investment predictability. (4) Specific and maximum possible flexibility should be implemented to allow the Union to fulfil its obligations in compliance with Article 323 of the Treaty on the Functioning of the European Union (TFEU). (5) The following special instruments are necessary to allow the Union to react to specified unforeseen circumstances, or to allow the financing of clearly identified expenditure which cannot be financed within the limits of the ceilings available for one or more headings as laid down in the MFF, thereby facilitating the budgetary procedure: the Emergency Aid Reserve, the European Union Solidarity Fund, the Flexibility Instrument, the European Globalisation Adjustment Fund, the Contingency Margin, the specific flexibility to tackle youth unemployment and strengthen research and the global margin for commitments for growth and employment, in particular youth employment. Specific provision should therefore be made for a possibility to enter commitment appropriations into the budget over and above the ceilings set out in the MFF where it is necessary to use special instruments. (6) If it is necessary to mobilise the guarantees given under the general budget of the Union for the loans provided under the Balance of Payment Facility or the European Financial Stabilisation Mechanism set out in Council Regulation (EC) No 332/2002 (2) and in Council Regulation (EU) No 407/2010 (3), respectively, the necessary amount should be mobilised over and above the ceilings of the commitments and payments appropriations of the MFF, while respecting the own-resources ceiling. (7) The MFF should be laid down in 2011 prices. The rules for technical adjustments to the MFF to recalculate the ceilings and margins available should also be laid down. (8) The MFF should not take account of budget items financed by assigned revenue within the meaning of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (4) (the "Financial Regulation"). (9) This Regulation might need to be revised in case of unforeseen circumstances that cannot be dealt with within ceilings established as part of the MFF. It is therefore necessary to provide for revision of the MFF in such cases. (10) Rules should be laid down for other situations that might require the MFF to be adjusted or revised. Such adjustments or revisions might be related to the implementation of the budget, measures linking effectiveness of funds to sound economic governance, revision of the Treaties, enlargements, the reunification of Cyprus, or delayed adoption of new rules governing certain policy areas. (11) The national envelopes for cohesion policy are established on the basis of the statistical data and forecasts used for the July 2012 update of the Commission proposal for this Regulation. Given the forecasting uncertainties and the impact for the capped Member States, and to take account of the particularly difficult situation of Member States suffering from the crisis, the Commission will, in 2016, review all Member States' total allocations under the "Investment for growth and jobs" goal of cohesion policy for the years 2017 to 2020. (12) It is necessary to provide for general rules on interinstitutional cooperation in the budgetary procedure. (13) Specific rules are also necessary for dealing with large-scale infrastructure projects whose lifetime extends well beyond the period set for the MFF. It is necessary to establish maximum amounts for the contributions from the general budget of the Union to those projects, thereby ensuring that they do not have any impact on other projects financed from that budget. (14) The Commission should present a proposal for a new multiannual financial framework before 1 January 2018, to enable the institutions to adopt it sufficiently in advance of the start of the subsequent multiannual financial framework. This Regulation should continue to apply in the event that a new financial framework is not adopted before the end of the term of the MFF laid down in this Regulation. (15) The Economic and Social Committee and the Committee of the Regions were consulted and have adopted opinions (5), HAS ADOPTED THIS REGULATION: CHAPTER 1 General provisions Article 1 Multiannual Financial Framework The multiannual financial framework for the period 2014 to 2020 (the "MFF") is set out in the Annex. Article 2 Mid-term review/revision of the MFF By the end of 2016 at the latest, the Commission shall present a review of the functioning of the MFF taking full account of the economic situation at that time as well as the latest macroeconomic projections. This compulsory review shall, as appropriate, be accompanied by a legislative proposal for the revision of this Regulation in accordance with the procedures set out in the TFEU. Without prejudice to Article 7 of this Regulation, preallocated national envelopes shall not be reduced through such a revision. Article 3 Compliance with the ceilings of the MFF 1. The European Parliament, the Council and the Commission shall, during each budgetary procedure and when implementing the budget for the year concerned, comply with the annual expenditure ceilings set out in the MFF. The sub-ceiling for Heading 2 as set out in the Annex is established without prejudice to the flexibility between the two pillars of the Common Agricultural Policy (CAP). The adjusted ceiling to be applied to pillar I of the CAP following the transfers between the European Agricultural Fund for Rural Development and direct payments shall be laid down in the relevant legal act and the MFF shall be adjusted accordingly under the technical adjustment provided for in Article 6(1) of this Regulation. 2. The special instruments provided for in Articles 9 to 15 shall ensure the flexibility of the MFF and shall be laid down in order to allow the budget procedure to run smoothly. The commitment appropriations may be entered in the budget over and above the ceilings of the relevant headings laid down in the MFF where it is necessary to use the resources from the Emergency Aid Reserve, the European Union Solidarity Fund, the Flexibility Instrument, the European Globalisation Adjustment Fund, the Contingency Margin, the specific flexibility to tackle youth unemployment and strengthen research and the global margin for commitments for growth and employment, in particular youth employment, in accordance with Council Regulation (EC) No 2012/2002 (6), Regulation (EC) No 1927/2006 of the European Parliament and of the Council (7), and the Interinstitutional Agreement between the European Parliament, the Council and the Commission (8). 3. Where a guarantee for a loan covered by the general budget of the Union in accordance with Regulation (EC) No 332/2002 or Regulation (EU) No 407/2010 needs to be mobilised, it shall be over and above the ceilings laid down in the MFF. Article 4 Respect of own resources ceiling 1. For each of the years covered by the MFF, the total appropriations for payments required, after annual adjustment and taking account of any other adjustments and revisions as well as the application of paragraphs 2 and 3 of Article 3, shall not be such as to produce a call-in rate for own resources that exceeds the own resources ceiling set in accordance with Decision 2007/436/EC, Euratom. 2. Where necessary, the ceilings set in the MFF shall be lowered by way of revision in order to ensure compliance with the own-resources ceiling set in accordance with Decision 2007/436/EC, Euratom. Article 5 Global margin for payments 1. Every year, starting in 2015, as part of the technical adjustment referred to in Article 6, the Commission shall adjust the payment ceiling for the years 2015-2020 upwards by an amount equivalent to the difference between the executed payments and the MFF payment ceiling of the year n-1. 2. The annual adjustments shall not exceed the following maximum amounts (in 2011 prices) for the years 2018-2020 as compared to the original payment ceiling of the relevant years: 2018 - EUR 7 billion 2019 - EUR 9 billion 2020 - EUR 10 billion. 3. Any upward adjustment shall be fully offset by a corresponding reduction of the payment ceiling for year n-1. Article 6 Technical adjustments 1. Each year the Commission, acting ahead of the budgetary procedure for year n+1, shall make the following technical adjustments to the MFF: (a) revaluation, at year n+1 prices, of the ceilings and of the overall figures for appropriations for commitments and appropriations for payments; (b) calculation of the margin available under the own-resources ceiling set in accordance with Decision 2007/436/EC, Euratom; (c) calculation of the absolute amount of the Contingency Margin provided for in Article 13; (d) calculation of the global margin for payments provided for in Article 5; (e) calculation of the global margin for commitments provided for in Article 14. 2. The Commission shall make the technical adjustments referred to in paragraph 1 on the basis of a fixed deflator of 2 % per year. 3. The Commission shall communicate the results of the technical adjustments referred to in paragraph 1 and the underlying economic forecasts to the European Parliament and the Council. 4. Without prejudice to Article 7 and 8, no further technical adjustments shall be made in respect of the year concerned, either during the year or as ex-post corrections during subsequent years. Article 7 Adjustment of cohesion policy envelopes 1. To take account of the particularly difficult situation of Member States suffering from the crisis, the Commission shall in 2016, together with the technical adjustment for the year 2017, review all Member States' total allocations under the "Investment for growth and jobs" goal of cohesion policy for the years 2017 to 2020, applying the allocation method defined in the relevant basic act on the basis of the then available most recent statistics and of the comparison, for the capped Member States, between the cumulated national GDP observed for the years 2014 and 2015 and the cumulated national GDP estimated in 2012. It shall adjust those total allocations whenever there is a cumulative divergence of more than +/- 5 %. 2. The adjustments required shall be spread in equal proportions over the years 2017-2020 and the corresponding ceilings of the MFF shall be modified accordingly. The payment ceilings shall also be modified accordingly to ensure an orderly progression in relation to the appropriations for commitments. 3. In its technical adustment for the year 2017, following the mid-term review of the eligibility of Member States for the Cohesion Fund provided for in Article 90(5) of Regulation (EU) No 1303/2013 of the European Parliament and of the Council (9), in case a Member State either becomes newly eligible to the Cohesion Fund or loses its existing eligibility, the Commission shall add or subtract the resulting amounts to or from the funds allocated to the Member State for the years 2017 to 2020. 4. The required adjustments resulting from paragraph 3 shall be spread in equal proportions over the years 2017-2020 and the corresponding ceilings of the MFF shall be modified accordingly. The payment ceilings shall also be modified accordingly to ensure an orderly progression in relation to the appropriations for commitments. 5. The total net effect, whether positive or negative, of the adjustments referred to in paragraphs 1 and 3 shall not exceed EUR 4 billion. Article 8 Adjustments related to measures linking effectiveness of funds to sound economic governance In the case of the lifting by the Commission of a suspension of budgetary commitments concerning the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development or the European Maritime and Fisheries Fund in the context of measures linking effectiveness of funds to sound economic governance, the Commission, in accordance with the relevant basic act, shall transfer the suspended commitments to the following years. Suspended commitments of year n may not be re-budgeted beyond year n+3. CHAPTER 2 Special instruments Article 9 Emergency Aid Reserve 1. The Emergency Aid Reserve is intended to allow for a rapid response to specific aid requirements of third countries following events which could not be foreseen when the budget was established, first and foremost for humanitarian operations, but also for civil crisis management and protection, and situations of particular pressure resulting from migratory flows at the Union's external borders where circumstances so require. 2. The annual amount of the Reserve is fixed at EUR 280 million (2011 prices) and may be used up to year n+1 in accordance with the Financial Regulation. The Reserve shall be entered in the general budget of the Union as a provision. The portion of the annual amount stemming from the previous year shall be drawn on first. That portion of the annual amount from year n which is not used in year n+1 shall lapse. Article 10 European Union Solidarity Fund 1. The European Union Solidarity Fund is intended to allow financial assistance in the event of major disasters occurring on the territory of a Member State or of a candidate country, as defined in the relevant basic act. There shall be a ceiling on the annual amount available for that Fund of EUR 500 million (2011 prices). On 1 October each year, at least one quarter of the annual amount shall remain available in order to cover needs arising until the end of that year. The portion of the annual amount not entered in the budget may be used up to year n+1. The portion of the annual amount stemming from the previous year shall be drawn on first. That portion of the annual amount from year n which is not used in year n+1 shall lapse. 2. In exceptional cases and if the remaining financial resources available in the European Union Solidarity Fund in the year of occurrence of the disaster, as defined in the relevant basic act, are not sufficient to cover the amount of assistance considered necessary by the European Parliament and the Council, the Commission may propose that the difference be financed through the annual amounts available for the following year. Article 11 Flexibility Instrument 1. The Flexibility Instrument is intended to allow the financing, for a given financial year, of clearly identified expenditure which could not be financed within the limits of the ceilings available for one or more other headings. There shall be a ceiling on the annual amount available for the Flexibility Instrument of EUR 471 million (2011 prices). 2. The unused portion of the annual amount of the Flexibility Instrument may be used up to year n+3. The portion of the annual amount stemming from previous years shall be used first, in order of age. That portion of the annual amount from year n which is not used in year n+3 shall lapse. Article 12 European Globalisation Adjustment Fund 1. The European Globalisation Adjustment Fund, the objectives and scope of which are defined in Regulation (EC) No 1927/2006 of the European Parliament and of the Council, shall not exceed a maximum annual amount of EUR 150 million (2011 prices). 2. The appropriations for the European Globalisation Adjustment Fund shall be entered in the general budget of the Union as a provision. Article 13 Contingency Margin 1. A Contingency Margin of up to 0,03 % of the Gross National Income of the Union shall be constituted outside the ceilings of the MFF, as a last-resort instrument to react to unforeseen circumstances. It may be mobilised only in relation to an amending or annual budget. 2. Recourse to the Contingency Margin shall not exceed, at any given year, the maximum amount foreseen in the annual technical adjustment of the MFF, and shall be consistent with the own-resources ceiling. 3. Amounts made available through the mobilisation of the Contingency Margin shall be fully offset against the margins in one or more MFF headings for the current or future financial years. 4. The amounts thus offset shall not be further mobilised in the context of the MFF. Recourse to the Contingency Margin shall not result in exceeding the total ceilings of commitment and payment appropriations laid down in the MFF for the current and future financial years. Article 14 Global margin for commitments for growth and employment, in particular youth employment 1. Margins left available below the MFF ceilings for commitment appropriations for the years 2014-2017 shall constitute a Global MFF Margin for commitments, to be made available over and above the ceilings established in the MFF for the years 2016 to 2020 for policy objectives related to growth and employment, in particular youth employment. 2. Each year, as part of the technical adjustment provided for in Article 6, the Commission shall calculate the amount available. The Global MFF Margin or part thereof may be mobilised by the European Parliament and the Council in the framework of the budgetary procedure pursuant to Article 314 TFEU. Article 15 Specific flexibility to tackle youth unemployment and strengthen research Up to EUR 2 543 million(in 2011 prices) may be frontloaded in 2014 and 2015, as part of the annual budgetary procedure, for specified policy objectives relating to youth employment, research, ERASMUS in particular for apprenticeships, and Small and Medium-sized Enterprises. That amount shall be fully offset against appropriations within and/or between headings in order to leave unchanged the total annual ceilings for the period 2014-2020 and the total allocation per heading or sub-heading over the period. Article 16 Contribution to the financing of large-scale projects 1. A maximum amount of EUR 6 300 million (in 2011 prices) shall be available for the European satellite navigation programmes (EGNOS and Galileo) from the general budget of the Union for the period 2014-2020. 2. A maximum amount of EUR 2 707 million (in 2011 prices) shall be available for the International Thermonuclear Experimental Reactor project (ITER) from the general budget of the Union for the period 2014-2020. 3. A maximum amount of EUR 3 786 million (in 2011 prices) shall be available for Copernicus (the European Earth Observation Programme) from the general budget of the Union for the period 2014-2020. CHAPTER 3 Revision Article 17 Revision of the MFF 1. Without prejudice to Article 4(2), Articles 18 to 22 and Article 25, in the event of unforeseen circumstances, the MFF may be revised in compliance with the own-resources ceiling set in accordance with Decision 2007/436/EC, Euratom. 2. As a general rule, any proposal for a revision of the MFF in accordance with paragraph 1 shall be presented and adopted before the start of the budgetary procedure for the year or the first of the years concerned. 3. Any proposal for revision of the MFF in accordance with paragraph 1 shall examine the scope for reallocating expenditure between the programmes covered by the heading concerned by the revision, with particular reference to any expected under-utilisation of appropriations. The objective should be that a significant amount, in absolute terms and as a percentage of the new expenditure planned, shall be within the existing ceiling for the heading. 4. Any revision of the MFF in accordance with paragraph 1 shall take into account the scope for offsetting any raising of the ceiling for one heading by the lowering of the ceiling for another. 5. Any revision of the MFF in accordance with paragraph 1 shall maintain an appropriate relationship between commitments and payments. Article 18 Revision related to implementation When notifying the European Parliament and the Council of the results of the technical adjustments to the MFF, the Commission shall present any proposals to revise the total appropriations for payments which it considers necessary, in the light of implementation, to ensure a sound management of the yearly payments ceilings and, in particular, their orderly progression in relation to the appropriations for commitments. The European Parliament and the Council shall decide on those proposals before 1 May of year n. Article 19 Revision following new rules or programmes for the Structural Funds, the Cohesion Fund the European Agricultural Fund for Rural Development, the European Maritim and Fisheries Fund, the Asylum and Migration Fund and the Internal Security Fund 1. In the event of the adoption after 1 January 2014 of new rules or programmes under shared management for the Structural Funds, the Cohesion Fund, the European Agricultural Fund for Rural Development, the European Maritime and Fisheries Fund, the Asylum and Migration Fund and the Internal Security Fund, the MFF shall be revised in order to transfer to subsequent years, in excess of the corresponding expenditure ceilings, allocations not used in 2014. 2. The revision concerning the transfer of unused allocation for the year 2014 shall be adopted before 1 May 2015. Article 20 Revision of the MFF in case of a revision of the Treaties Should a revision of the Treaties with budgetary implications occur between 2014 and 2020, the MFF shall be revised accordingly. Article 21 Revision of the MFF in the event of enlargement of the Union If there is an accession or accessions to the Union between 2014 and 2020, the MFF shall be revised to take account of the expenditure requirements resulting therefrom. Article 22 Revision of the MFF in the event of the reunification of Cyprus In the event of of the reunification of Cyprus between 2014 and 2020, the MFF shall be revised to take account of the comprehensive settlement of the Cyprus problem and the additional financial needs resulting from the reunification. Article 23 Interinstitutional cooperation in the budgetary procedure The European Parliament, the Council and the Commission (hereinafter "the institutions") shall take measures to facilitate the annual budgetary procedure. The institutions shall cooperate in good faith throughout the procedure with a view to reconciling their positions. The institutions shall, at all stages of the procedure, cooperate through appropriate interinstitutional contacts in order to monitor the progress of the work and analyse the degree of convergence. The institutions shall ensure that their respective calendars of work are coordinated as far as possible, in order to enable proceedings to be conducted in a coherent and convergent fashion, leading to the final adoption of the general budget of the Union. Trilogues may be held at all stages of the procedure and at different levels of representation, depending on the nature of the expected discussions. Each institution, in accordance with its own rules of procedure, shall designate its participants for each meeting, define its mandate for the negotiations and inform the other institutions in good time of the arrangements for the meetings. Article 24 Unity of the budget All expenditure and revenue of the Union and Euratom shall be included in the general budget of the Union in accordance with Article 7 of the Financial Regulation, including expenditure resulting from any relevant decision taken unanimously by the Council after consulting the European Parliament, in the framework of Article 332 TFEU. Article 25 Transition towards the next multiannual financial framework Before 1 January 2018, the Commission shall present a proposal for a new multiannual financial framework. If no Council regulation determining a new multiannual financial framework has been adopted before 31 December 2020, the ceilings and other provisions corresponding to the last year of the MFF shall be extended until a regulation determining a new financial framework is adopted. If a new Member State accedes to the Union after 2020, the extended financial framework shall, if necessary, be revised in order to take the accesion into account. Article 26 Entry into force This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 2 December 2013. For the Council The President E. GUSTAS (1) Council Decision 2007/436/EC, Euratom of 7 June 2007 on the system of the European Communities' own resources (OJ L 163, 23.6.2007, p. 17). (2) Council Regulation (EC) No 332/2002 of 18 February 2002 establishing a facility providing medium-term financial assistance for Member States' balances of payments (OJ L 53, 23.2.2002, p. 1). (3) Council Regulation (EU) No 407/2010 of 11 May 2010 establishing a European financial stabilisation mechanism (OJ L 118, 12.5.2010, p. 1). (4) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (5) Opinion of the European Economic and Social Committee on the 'Proposal for a Council Regulation laying down the multiannual financial framework for the years 2014-2020' (OJ C 229, 31.7.2012, p. 32); Opinion of the Committee of the Regions on 'New Multiannual Financial Framework post-2013' (OJ C 391, 18.12.2012, p. 31). (6) Council Regulation (EC) No 2012/2002 of 11 November 2002 establishing the European Union Solidarity Fund (OJ L 311, 14.11.2002, p. 3). (7) Regulation (EC) No 1927/2006 of the European Parliament and of the Council of 20 December 2006 on establishing the European Globalisation Adjustment Fund (JO L 406, 30.12.2006, p. 1). (8) Interinstitutional Agreement between the European Parliament, the Council and the Commission of 2 December 2013 on budgetary discipline, cooperation in budgetary matters and on sound financial management (OJ C 373, 20.12.2013, p. 1). (9) Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund covered by the Common Strategic Framework and laying down general provisions on the European Regional Development Fund, the European Social Fund and the Cohesion Fund and repealing Council Regulation (EC) No 1083/2006 (See page 320 of this Official Journal.). ANNEX I MULTIANNUAL FINANCIAL FRAMEWORK (EU-28) (EUR million - 2011 prices) COMMITMENT APPROPRIATIONS 2014 2015 2016 2017 2018 2019 2020 Total 2014–2020 1. Smart and Inclusive Growth 60 283 61 725 62 771 64 238 65 528 67 214 69 004 450 763 1a: Competitiveness for growth and jobs 15 605 16 321 16 726 17 693 18 490 19 700 21 079 125 614 1b: Economic, social and territorial cohesion 44 678 45 404 46 045 46 545 47 038 47 514 47 925 325 149 2. Sustainable Growth: Natural Resources 55 883 55 060 54 261 53 448 52 466 51 503 50 558 373 179 of which: Market related expenditure and direct payments 41 585 40 989 40 421 39 837 39 079 38 335 37 605 277 851 3. Security and citizenship 2 053 2 075 2 154 2 232 2 312 2 391 2 469 15 686 4. Global Europe 7 854 8 083 8 281 8 375 8 553 8 764 8 794 58 704 5. Administration 8 218 8 385 8 589 8 807 9 007 9 206 9 417 61 629 of which: Administrative expenditure of the institutions 6 649 6 791 6 955 7 110 7 278 7 425 7 590 49 798 6. Compensations 27 0 0 0 0 0 0 27 TOTAL COMMITMENT APPROPRIATIONS 134 318 135 328 136 056 137 100 137 866 139 078 140 242 959 988 as a percentage of GNI 1,03 % 1,02 % 1,00 % 1,00 % 0,99 % 0,98 % 0,98 % 1,00 % TOTAL PAYMENT APPROPRIATIONS 128 030 131 095 131 046 126 777 129 778 130 893 130 781 908 400 as a percentage of GNI 0,98 % 0,98 % 0,97 % 0,92 % 0,93 % 0,93 % 0,91 % 0,95 % Margin available 0,25 % 0,25 % 0,26 % 0,31 % 0,30 % 0,30 % 0,32 % 0,28 % Own Resources Ceiling as a percentage of GNI 1,23 % 1,23 % 1,23 % 1,23 % 1,23 % 1,23 % 1,23 % 1,23 %

Multiannual EU budget (2014-2020) Multiannual EU budget (2014-2020) SUMMARY OF: Regulation (EU, Euratom) No 1311/2013 — the EU’s multiannual financial framework for the years 2014-2020 WHAT IS THE AIM OF THE REGULATION? It sets out the maximum annual amounts that can be spent on the EU’s different policy areas over the 2014-2020 period. KEY POINTS The EU adopted the 7-year plan for the 2014-2020 period in December 2013. The multiannual financial framework (MFF) amounts to €960 billion in commitments (legal promise to provide finance, assuming certain conditions are met) and €908.4 billion in payments (actual transfers to beneficiaries) over the 7-year period, expressed in constant prices of the year 2011.The MFF regulation lays down ceilings (maximum amounts) for each category of EU spending over the period. These must be respected when agreeing the EU’s annual budgets.The 2014-2020 MFF is broken down into headings, as follows. Heading 1 - Smart and inclusive growth: €450.763 billion (of which €325.149 billion for economic, social and territorial cohesion). Heading 2 - Sustainable growth: natural resources: €373.179 billion. Heading 3 - Security and citizenship: €15.686 billion. Heading 4 - Global Europe: €58.704 billion. Heading 5 - Administration: €61.629 billion. A central focus of the 2014-2020 MFF is on growth and employment. Subheading 1a on ‘competitiveness’ has increased by over 37% compared with the previous 2007-2013 MFF, reflecting the importance of this political priority. However, the new MFF is smaller than its predecessor, given that many EU countries face budgetary pressures on the home front. The MFF regulation also provides for special instruments that allow the EU to react to specified, unforeseen circumstances. It can also allow the financing of clearly identified expenditure that cannot be financed within the limits of the ceilings that are available for one or more headings, notably: the Emergency Aid Reserve (used to finance, for example, humanitarian aid and civilian crisis management); the European Union Solidarity Fund; the Flexibility Instrument; the European Globalisation Adjustment Fund; the Contingency Margin (a last-resort instrument to react to unforeseen circumstances). An interinstitutional agreement on budgetary discipline, cooperation in budgetary matters and sound financial management was also agreed between the European Parliament, the Council and the European Commission. This should rationalise the annual budgetary procedure and complement the MFF regulation. Reallocation of 2014 unused commitments The MFF regulation provides that in the event of the adoption of programmes under shared management for the Structural and Investment Funds, the European Agricultural Fund for Rural Development, the European Maritime and Fisheries Fund, the Asylum, Migration and Integration Fund and the Internal Security Fund after 1 January 2014, the MFF should be revised to reallocate the amounts not used in 2014 to subsequent years.As a result, the MFF regulation has been revised so as to allow the transfer of 2014’s unused commitments: €16.5 billion to 2015, €4.5 billion to 2016 and €0.1 billion to 2017. This was due to the late adoption of 300 out of the 645 EU programmes in areas covered by the abovementioned EU funds.The revision of the EU’s MFF keeps the total expenditure ceilings unchanged and involves no additional money. Review The MFF had to be reviewed no later than in 2016 to allow the European Parliament (elected in 2014), the Council and the Commission (appointed in 2014) to reassess the priorities for the remaining years of the framework. This assessment was undertaken in light of the economic situation at the time as well as of the latest macroeconomic projections. Following the mid-term reviewRegulation (EU, Euratom) No 1311/2013 was amended by Regulation (EU, Euratom) 2017/1123 in 2017. The revised MFF increases the resources earmarked for the EU’s main priorities by €6.01 billion for the years 2017-2020, as follows: €2.08 billion for boosting growth and creating jobs through programmes such as the youth employment initiative (+ €1.2 billion), Horizon 2020 (+ €200 million), and Erasmus+ (+ €100 million); €2.55 billion for addressing migration, enhancing security and strengthening external border control; €1.39 billion for tackling the root causes of migration. Each year, ahead of the budgetary procedure for the following year, the Commission makes a technical adjustment to the MFF in line with movements in the EU’s gross national income and prices. The results of this adjustment for 2018 were first communicated to the European Parliament and the Council in May 2017. However, these results were subsequently revised to take into account the 2017 amendment to Regulation (EU, Euratom) No 1311/2013 and were communicated to the European Parliament and the Council in September 2017. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2014. BACKGROUND For more information, see: Multiannual financial framework (European Commission) Multiannual financial framework (Council). MAIN DOCUMENT Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (OJ L 347, 20.12.2013, pp. 884-891) Successive amendments to Regulation (EU, Euratom) No 1311/2013 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Communication from the Commission to the Council and the European Parliament — Technical adjustment of the financial framework for 2018 in line with movements in GNI (ESA 2010) (Article 6 of Council Regulation No 1311/2013 laying down the multiannual financial framework for the years 2014-2020) updating and replacing Communication COM(2017)220 final (COM(2017) 473 final, 15.9.2017) Interinstitutional agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (OJ C 373, 20.12.2013, pp. 1-11) last update 29.11.2017

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9.4.2008 EN Official Journal of the European Union L 97/72 REGULATION (EC) No 300/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), in the light of the joint text approved by the Conciliation Committee on 16 January 2008. Whereas: (1) In order to protect persons and goods within the European Union, acts of unlawful interference with civil aircraft that jeopardise the security of civil aviation should be prevented by establishing common rules for safeguarding civil aviation. This objective should be achieved by setting common rules and common basic standards on aviation security as well as mechanisms for monitoring compliance. (2) It is desirable, in the interests of civil aviation security generally, to provide the basis for a common interpretation of Annex 17 to the Chicago Convention on International Civil Aviation of 7 December 1944. (3) Regulation (EC) No 2320/2002 of the European Parliament and of the Council of 16 December 2002 establishing common rules in the field of civil aviation security (3) was adopted as a result of the events of 11 September 2001 in the United States. A common approach is needed in the field of civil aviation security and consideration should be given to the most effective means of offering assistance following terrorist acts that have a major impact in the transport field. (4) The content of Regulation (EC) No 2320/2002 should be revised in the light of the experience gained, and the Regulation itself should be repealed and replaced by this Regulation seeking the simplification, harmonisation and clarification of the existing rules and the improvement of the levels of security. (5) Given the need for more flexibility in adopting security measures and procedures in order to meet evolving risk assessments and to allow new technologies to be introduced, this Regulation should lay down the basic principles of what has to be done in order to safeguard civil aviation against acts of unlawful interference without going into the technical and procedural details of how they are to be implemented. (6) This Regulation should apply to airports serving civil aviation located in the territory of a Member State, to operators providing services at such airports and to entities providing goods and/or services to or through such airports. (7) Without prejudice to the Convention on offences and certain other acts committed on board aircraft, Tokyo, 1963, the Convention for the suppression of unlawful seizure of aircraft, The Hague, 1970, and the Convention for the suppression of unlawful acts against the safety of civil aviation, Montreal, 1971, this Regulation should also cover security measures that apply on board an aircraft, or during a flight, of Community air carriers. (8) Each Member State retains the competence to decide whether to deploy in-flight security officers on aircraft registered in that Member State and on flights of air carriers licensed by it as well as to ensure, in accordance with paragraph 4.7.7 of Annex 17 to the Chicago Convention on International Civil Aviation and under the terms of that Convention, that such officers are government personnel who are specially selected and trained, taking into account the required security and safety aspects on board an aircraft. (9) The various types of civil aviation do not necessarily present the same level of threat. In setting common basic standards on aviation security, the size of the aircraft, the nature of the operation and/or the frequency of operations at airports should be taken into account with a view to permitting the grant of derogations. (10) Member States should also be allowed, on the basis of a risk assessment, to apply more stringent measures than those laid down in this Regulation. (11) Third countries may require the application of measures that differ from those laid down in this Regulation in respect of flights from an airport in a Member State to, or over, that third country. However, without prejudice to any bilateral agreements to which the Community is a party, it should be possible for the Commission to examine the measures required by the third country. (12) Even though, within a single Member State, there may be two or more bodies involved in aviation security, each Member State should designate a single authority responsible for the coordination and monitoring of the implementation of security standards. (13) In order to define responsibilities for the implementation of the common basic standards on aviation security and to describe what measures are required by operators and other entities for this purpose, each Member State should draw up a national civil aviation security programme. Furthermore, each airport operator, air carrier and entity implementing aviation security standards should draw up, apply and maintain a security programme in order to comply both with this Regulation and with whichever national civil aviation security programme is applicable. (14) In order to monitor compliance with this Regulation and with the national civil aviation security programme, each Member State should draw up and ensure the implementation of a national programme to check the level and quality of civil aviation security. (15) In order to monitor the application by Member States of this Regulation, and also to make recommendations to improve aviation security, the Commission should conduct inspections, including unannounced inspections. (16) As a general rule, the Commission should publish measures that have a direct impact on passengers. Implementing acts setting out common measures and procedures for the implementation of the common basic standards on aviation security which contain sensitive security information, together with Commission inspection reports and the answers of the appropriate authorities should be regarded as EU classified information within the meaning of Commission Decision 2001/844/EC, ECSC, Euratom of 29 November 2001 amending its internal rules of procedure (4). Those items should not be published and should be made available only to those operators and entities with a legitimate interest. (17) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5). (18) In particular, the Commission should be empowered to adopt general measures amending non-essential elements of the common basic standards by supplementing them, set criteria allowing Member States both to derogate from the common basic standards and to adopt alternative security measures, and adopt specifications for national quality control programmes. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (19) When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of common rules for safeguarding civil aviation. (20) The goal of ‘one-stop security’ for all flights within the European Union should be advanced. (21) Furthermore, it should not be necessary to rescreen passengers or their baggage arriving on flights from third countries that have aviation security standards equivalent to those laid down by this Regulation. Therefore, without prejudice to the right of each Member State to apply more stringent measures, or to the respective competences of the Community and Member States, decisions of the Commission, and, where necessary, agreements between the Community and third countries, which recognise that the security standards applied in the third country are equivalent to the common standards, should be encouraged since these further one-stop security. (22) This Regulation is without prejudice to the application of rules on aviation safety, including those relating to the transport of dangerous goods. (23) Penalties should be provided for infringements of the provisions of this Regulation. Those penalties, which may be of a civil or administrative nature, should be effective, proportionate and dissuasive. (24) The Ministerial Statement on Gibraltar Airport, agreed in Cordoba on 18 September 2006 during the first Ministerial meeting of the Forum of Dialogue on Gibraltar, will replace the Joint Declaration on Gibraltar Airport made in London on 2 December 1987, and full compliance with it will be deemed to constitute compliance with the 1987 Declaration. (25) Since the objectives of this Regulation, namely to safeguard civil aviation against acts of unlawful interference and to provide a basis for a common interpretation of Annex 17 to the Chicago Convention on International Civil Aviation, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of this Regulation, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS REGULATION: Article 1 Objectives 1. This Regulation establishes common rules to protect civil aviation against acts of unlawful interference that jeopardise the security of civil aviation. It also provides the basis for a common interpretation of Annex 17 to the Chicago Convention on International Civil Aviation. 2. The means of achieving the objectives set out in paragraph 1 shall be: (a) the setting of common rules and common basic standards on aviation security; (b) mechanisms for monitoring compliance. Article 2 Scope 1. This Regulation shall apply to the following: (a) all airports or parts of airports located in the territory of a Member State that are not exclusively used for military purposes; (b) all operators, including air carriers, providing services at airports referred to in point (a); (c) all entities applying aviation security standards that operate from premises located inside or outside airport premises and provide goods and/or services to or through airports referred to in point (a). 2. The application of this Regulation to the airport of Gibraltar is understood to be without prejudice to the respective legal positions of the Kingdom of Spain and the United Kingdom with regard to the dispute over sovereignty over the territory in which the airport is situated. Article 3 Definitions For the purposes of this Regulation: 1. ‘civil aviation’ means any air operation carried out by civil aircraft, excluding operations carried out by State aircraft referred to in Article 3 of the Chicago Convention on International Civil Aviation; 2. ‘aviation security’ means the combination of measures and human and material resources intended to safeguard civil aviation against acts of unlawful interference that jeopardise the security of civil aviation; 3. ‘operator’ means a person, organisation or enterprise engaged, or offering to engage, in an air transport operation; 4. ‘air carrier’ means an air transport undertaking holding a valid operating licence or equivalent; 5. ‘Community air carrier’ means an air carrier holding a valid operating licence granted by a Member State in accordance with Council Regulation (EEC) No 2407/92 of 23 July 1992 on licensing of air carriers (6); 6. ‘entity’ means a person, organisation or enterprise, other than an operator; 7. ‘prohibited articles’ means weapons, explosives or other dangerous devices, articles or substances that may be used to commit an act of unlawful interference that jeopardises the security of civil aviation; 8. ‘screening’ means the application of technical or other means which are intended to identify and/or detect prohibited articles; 9. ‘security control’ means the application of means by which the introduction of prohibited articles may be prevented; 10. ‘access control’ means the application of means by which the entry of unauthorised persons or unauthorised vehicles, or both, may be prevented; 11. ‘airside’ means the movement area of an airport, adjacent terrain and buildings or portions thereof, access to which is restricted; 12. ‘landside’ means those parts of an airport, adjacent terrain and buildings or portions thereof that are not airside; 13. ‘security restricted area’ means that area of airside where, in addition to access being restricted, other aviation security standards are applied; 14. ‘demarcated area’ means an area that is separated by means of access control either from security restricted areas, or, if the demarcated area itself is a security restricted area, from other security restricted areas of an airport; 15. ‘background check’ means a recorded check of a person’s identity, including any criminal history, as part of the assessment of an individual’s suitability for unescorted access to security restricted areas; 16. ‘transfer passengers, baggage, cargo or mail’ means passengers, baggage, cargo or mail departing on an aircraft other than that on which they arrived; 17. ‘transit passengers, baggage, cargo or mail’ means passengers, baggage, cargo or mail departing on the same aircraft as that on which they arrived; 18. ‘potentially disruptive passenger’ means a passenger who is either a deportee, a person deemed to be inadmissible for immigration reasons or a person in lawful custody; 19. ‘cabin baggage’ means baggage intended for carriage in the cabin of an aircraft; 20. ‘hold baggage’ means baggage intended for carriage in the hold of an aircraft; 21. ‘accompanied hold baggage’ means baggage, carried in the hold of an aircraft, which has been checked in for a flight by a passenger travelling on that same flight; 22. ‘air carrier mail’ means mail whose origin and destination are both an air carrier; 23. ‘air carrier materials’ means materials either whose origin and destination are both an air carrier or that are used by an air carrier; 24. ‘mail’ means dispatches of correspondence and other items, other than air carrier mail, tendered by and intended for delivery to postal services in accordance with the rules of the Universal Postal Union; 25. ‘cargo’ means any property intended for carriage on an aircraft, other than baggage, mail, air carrier mail, air carrier materials and in-flight supplies; 26. ‘regulated agent’ means an air carrier, agent, freight forwarder or any other entity who ensures security controls in respect of cargo or mail; 27. ‘known consignor’ means a consignor who originates cargo or mail for its own account and whose procedures meet common security rules and standards sufficient to allow carriage of cargo or mail on any aircraft; 28. ‘account consignor’ means a consignor who originates cargo or mail for its own account and whose procedures meet common security rules and standards sufficient to allow carriage of that cargo on all-cargo aircraft or mail on all-mail aircraft; 29. ‘aircraft security check’ means an inspection of those parts of the interior of the aircraft to which passengers may have had access, together with an inspection of the hold of the aircraft in order to detect prohibited articles and unlawful interferences with the aircraft; 30. ‘aircraft security search’ means an inspection of the interior and accessible exterior of the aircraft in order to detect prohibited articles and unlawful interferences that jeopardise the security of the aircraft; 31. ‘in-flight security officer’ means a person who is employed by a state to travel on an aircraft of an air carrier licensed by it with the purpose of protecting that aircraft and its occupants against acts of unlawful interference that jeopardise the security of the flight. Article 4 Common basic standards 1. The common basic standards for safeguarding civil aviation against acts of unlawful interference that jeopardise the security of civil aviation shall be as laid down in the Annex. Additional common basic standards not foreseen at the entry into force of this Regulation should be added to the Annex in accordance with the procedure referred to in Article 251 of the Treaty. 2. General measures, designed to amend non-essential elements of the common basic standards referred to in paragraph 1 by supplementing them, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). These general measures shall concern: (a) methods of screening allowed; (b) categories of articles that may be prohibited; (c) as regards access control, grounds for granting access to airside and security restricted areas; (d) methods allowed for the examination of vehicles, aircraft security checks and aircraft security searches; (e) criteria for recognising the equivalence of security standards of third countries; (f) conditions under which cargo and mail shall be screened or subjected to other security controls, as well as the process for the approval or designation of regulated agents, known consignors and account consignors; (g) conditions under which air carrier mail and air carrier materials shall be screened or subjected to other security controls; (h) conditions under which in-flight supplies and airport supplies shall be screened or subjected to other security controls, as well as the process for the approval or designation of regulated suppliers and known suppliers; (i) criteria for defining critical parts of security restricted areas; (j) criteria for staff recruitment and methods of training; (k) conditions under which special security procedures or exemptions from security controls may be applied; and (l) any general measures designed to amend non-essential elements of the common basic standards referred to in paragraph 1 by supplementing them not foreseen at the date of entry into force of this Regulation. On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 19(4). 3. Detailed measures for the implementation of the common basic standards referred to in paragraph 1 and the general measures referred to in paragraph 2 shall be laid down in accordance with the regulatory procedure referred to in Article 19(2). These shall include: (a) requirements and procedures for screening; (b) a list of prohibited articles; (c) requirements and procedures for access control; (d) requirements and procedures for the examination of vehicles, aircraft security checks and aircraft security searches; (e) decisions to recognise the equivalence of security standards applied in a third country; (f) as regards cargo and mail, procedures for the approval or designation of, and the obligations to be fulfilled by, regulated agents, known consignors and account consignors; (g) requirements and procedures for security controls of air carrier mail and air carrier materials; (h) as regards in-flight supplies and airport supplies, procedures for the approval or designation of, and the obligations to be fulfilled by, regulated suppliers and known suppliers; (i) definition of critical parts of security restricted areas; (j) staff recruitment and training requirements; (k) special security procedures or exemptions from security controls; (l) technical specifications and procedures for approval and use of security equipment; and (m) requirements and procedures concerning potentially disruptive passengers. 4. The Commission shall, by amending this Regulation through a decision in accordance with the regulatory procedure with scrutiny referred to in Article 19(3), set criteria to allow Member States to derogate from the common basic standards referred to in paragraph 1 and to adopt alternative security measures that provide an adequate level of protection on the basis of a local risk assessment. Such alternative measures shall be justified by reasons relating to the size of the aircraft, or by reasons relating to the nature, scale or frequency of operations or of other relevant activities. On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 19(4). The Member States shall inform the Commission of such measures. 5. Member States shall ensure the application in their territory of the common basic standards referred to in paragraph 1. Where a Member State has reason to believe that the level of aviation security has been compromised through a security breach, it shall ensure that appropriate and prompt action is taken to rectify that breach and ensure the continuing security of civil aviation. Article 5 Security costs Subject to the relevant rules of Community law, each Member State may determine in which circumstances, and the extent to which, the costs of security measures taken under this Regulation to protect civil aviation against acts of unlawful interference should be borne by the State, the airport entities, air carriers, other responsible agencies, or users. If appropriate, and in conformity with Community law, Member States may contribute with users to the costs of more stringent security measures taken under this Regulation. As far as may be practicable, any charges or transfers of security costs shall be directly related to the costs of providing the security services concerned and shall be designed to recover no more than the relevant costs involved. Article 6 More stringent measures applied by Member States 1. Member States may apply more stringent measures than the common basic standards referred to in Article 4. In doing so, they shall act on the basis of a risk assessment and in compliance with Community law. Τhose measures shall be relevant, objective, non-discriminatory and proportional to the risk that is being addressed. 2. Member States shall inform the Commission of such measures as soon as possible after their application. Upon reception of such information, the Commission shall transmit this information to the other Member States. 3. Member States are not required to inform the Commission where the measures concerned are limited to a given flight on a specific date. Article 7 Security measures required by third countries 1. Without prejudice to any bilateral agreements to which the Community is a party, a Member State shall notify the Commission of measures required by a third country if they differ from the common basic standards referred to in Article 4 in respect of flights from an airport in a Member State to, or over, that third country. 2. At the request of the Member State concerned or on its own initiative, the Commission shall examine the application of any measures notified under paragraph 1 and may, in accordance with the regulatory procedure referred to in Article 19(2), draw up an appropriate response to the third country concerned. 3. Paragraphs 1 and 2 shall not apply if: (a) the Member State concerned applies the measures concerned in accordance with Article 6; or (b) the requirement of the third country is limited to a given flight on a specific date. Article 8 Cooperation with the International Civil Aviation Organisation Without prejudice to Article 300 of the Treaty, the Commission may conclude a Memorandum of Understanding concerning audits with the International Civil Aviation Organisation (ICAO) in order to avoid duplicate monitoring of Member States’ compliance with Annex 17 to the Chicago Convention on International Civil Aviation. Article 9 Appropriate authority Where, within a single Member State, two or more bodies are involved in civil aviation security, that Member State shall designate a single authority (hereinafter referred to as the appropriate authority) to be responsible for the coordination and monitoring of the implementation of the common basic standards referred to in Article 4. Article 10 National civil aviation security programme 1. Every Member State shall draw up, apply and maintain a national civil aviation security programme. That programme shall define responsibilities for the implementation of the common basic standards referred to in Article 4 and shall describe the measures required by operators and entities for this purpose. 2. The appropriate authority shall make available in writing on a ‘need to know’ basis the appropriate parts of its national civil aviation security programme to operators and entities which it deems to have a legitimate interest. Article 11 National quality control programme 1. Every Member State shall draw up, apply and maintain a national quality control programme. That programme shall enable the Member State to check the quality of civil aviation security in order to monitor compliance both with this Regulation and with its national civil aviation security programme. 2. The specifications for the national quality control programme shall be adopted by amending this Regulation through the addition of an annex in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 19(4). The programme shall allow for the swift detection and correction of deficiencies. It shall also provide that all airports, operators and entities responsible for the implementation of aviation security standards that are located in the territory of the Member State concerned shall be regularly monitored directly by, or under the supervision of, the appropriate authority. Article 12 Airport security programme 1. Every airport operator shall draw up, apply and maintain an airport security programme. That programme shall describe the methods and procedures which are to be followed by the airport operator in order to comply both with this Regulation and with the national civil aviation security programme of the Member State in which the airport is located. The programme shall include internal quality control provisions describing how compliance with these methods and procedures is to be monitored by the airport operator. 2. The airport security programme shall be submitted to the appropriate authority, which may take further action if appropriate. Article 13 Air carrier security programme 1. Every air carrier shall draw up, apply and maintain an air carrier security programme. That programme shall describe the methods and procedures which are to be followed by the air carrier in order to comply both with this Regulation and with the national civil aviation security programme of the Member State from which it provides services. The programme shall include internal quality control provisions describing how compliance with these methods and procedures is to be monitored by the air carrier. 2. Upon request, the air carrier security programme shall be submitted to the appropriate authority, which may take further action if appropriate. 3. Where a Community air carrier security programme has been validated by the appropriate authority of the Member State granting the operating licence, the air carrier shall be recognised by all other Member States as having fulfilled the requirements of paragraph 1. This is without prejudice to a Member State’s right to request from any air carrier details of its implementation of: (a) the security measures applied by that Member State under Article 6; and/or (b) local procedures that are applicable at the airports served. Article 14 Entity security programme 1. Every entity required under the national civil aviation security programme referred to in Article 10 to apply aviation security standards shall draw up, apply and maintain a security programme. That programme shall describe the methods and procedures which are to be followed by the entity in order to comply with the national civil aviation security programme of the Member State in respect of its operations in that Member State. The programme shall include internal quality control provisions describing how compliance with these methods and procedures is to be monitored by the entity itself. 2. Upon request, the security programme of the entity applying aviation security standards shall be submitted to the appropriate authority, which may take further action if appropriate. Article 15 Commission inspections 1. The Commission, acting in cooperation with the appropriate authority of the Member State concerned, shall conduct inspections, including inspections of airports, operators and entities applying aviation security standards, in order to monitor the application by Member States of this Regulation and, as appropriate, to make recommendations to improve aviation security. For this purpose, the appropriate authority shall inform the Commission in writing of all airports in its territory serving civil aviation other than those covered by Article 4(4). The procedures for conducting Commission inspections shall be adopted in accordance with the regulatory procedure referred to in Article 19(2). 2. Commission inspections of airports, operators and entities applying aviation security standards shall be unannounced. The Commission shall in good time before an inspection inform the Member State concerned thereof. 3. Each Commission inspection report shall be communicated to the appropriate authority of the Member State concerned, which shall, in its answer, set out the measures taken to remedy any identified deficiencies. The report, together with the answer of the appropriate authority, shall subsequently be communicated to the appropriate authority of the other Member States. Article 16 Annual report Every year the Commission shall present a report to the European Parliament, the Council and the Member States informing them of the application of this Regulation and of its impact on improving aviation security. Article 17 Stakeholders’ Advisory Group Without prejudice to the role of the Committee referred to in Article 19, the Commission shall establish a Stakeholders’ Advisory Group on Aviation Security, composed of European representative organisations engaged in, or directly affected by, aviation security. The role of this group shall be solely to advise the Commission. The Committee referred to in Article 19 shall keep the Stakeholders’ Advisory Group informed during the entire regulatory process. Article 18 Dissemination of information As a general rule, the Commission shall publish measures that have a direct impact on passengers. However, the following documents shall be regarded as EU classified information within the meaning of Decision 2001/844/EC, ECSC, Euratom: (a) measures and procedures as referred to in Articles 4(3), 4(4), 6(1) and 7(1), if containing sensitive security information; (b) the Commission inspection reports and the answers of the appropriate authorities referred to in Article 15(3). Article 19 Committee procedure 1. The Commission shall be assisted by a Committee. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at one month. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 4. Where reference is made to this paragraph, Article 5a(1), (2), (4), and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 20 Agreements between the Community and third countries When appropriate, and in conformity with Community law, agreements recognising that the security standards applied in a third country are equivalent to Community standards could be envisaged in aviation agreements between the Community and a third country in accordance with Article 300 of the Treaty, in order to advance the goal of ‘one-stop security’ for all flights between the European Union and third countries. Article 21 Penalties Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Article 22 Commission report on financing The Commission will report, no later than 31 December 2008, on the principles of the financing of the costs of civil aviation security measures. That report will consider what steps need to be taken in order to ensure that security charges are used exclusively to meet security costs, and to improve the transparency of such charges. The report will also address the principles necessary to safeguard undistorted competition between airports and between air carriers, and the different methods to ensure consumer protection as regards the distribution of the costs of security measures between taxpayers and users. The Commission report will be accompanied, if appropriate, by a legislative proposal. Article 23 Repeal Regulation (EC) No 2320/2002 is hereby repealed. Article 24 Entry into force 1. This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. 2. It shall apply as from the date specified in the implementing rules adopted in accordance with the procedures referred to in Article 4(2) and (3), but not later than 24 months after the entry into force of this Regulation. 3. By way of exception to paragraph 2, Articles 4(2), 4(3), 4(4), 8, 11(2), 15(1) second subparagraph, 17, 19 and 22 shall apply from the date of entry into force of this Regulation. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 11 March 2008. For the European Parliament The President H.-G. PÖTTERING For the Council The President J. LENARČIČ (1) OJ C 185, 8.8.2006, p. 17. (2) Opinion of the European Parliament of 15 June 2006 (OJ C 300 E, 9.12.2006, p. 463), Council Common Position of 11 December 2006 (OJ C 70 E, 27.3.2007, p. 21) and Position of the European Parliament of 25 April 2007 (not yet published in the Official Journal), Legislative Resolution of the European Parliament of 11 March 2008 (not yet published in the Official Journal) and Council Decision of 4 March 2008. (3) OJ L 355, 30.12.2002, p. 1. Regulation as amended by Regulation (EC) No 849/2004 (OJ L 158, 30.4.2004, p. 1, corrected by OJ L 229, 29.6.2004, p. 3). (4) OJ L 317, 3.12.2001, p. 1. Decision as last amended by Decision 2006/548/EC, Euratom (OJ L 215, 5.8.2006, p. 38). (5) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11). (6) OJ L 240, 24.8.1992, p. 1. ANNEX COMMON BASIC STANDARDS FOR SAFEGUARDING CIVIL AVIATION AGAINST ACTS OF UNLAWFUL INTERFERENCE (ARTICLE 4) 1. AIRPORT SECURITY 1.1. Airport planning requirements 1. When designing and constructing new airport facilities or altering existing airport facilities, requirements for the implementation of the common basic standards set out in this Annex and its implementing acts shall be fully taken into account. 2. At airports the following areas shall be established: (a) landside; (b) airside; (c) security restricted areas; and (d) critical parts of security restricted areas. 1.2. Access control 1. Access to airside shall be restricted in order to prevent unauthorised persons and vehicles from entering these areas. 2. Access to security restricted areas shall be controlled in order to ensure that no unauthorised persons and vehicles enter these areas. 3. Persons and vehicles may be granted access to airside and security restricted areas only if they fulfil the required security conditions. 4. Persons, including flight crew members, shall have successfully completed a background check before either a crew identification card or an airport identification card authorising unescorted access to security restricted areas is issued to them. 1.3. Screening of persons other than passengers and items carried 1. Persons other than passengers, together with items carried, shall be screened on a continuous random basis upon entering security restricted areas in order to prevent prohibited articles from being introduced into these areas. 2. All persons other than passengers, together with items carried, shall be screened upon entering critical parts of security restricted areas in order to prevent prohibited articles from being introduced into these parts. 1.4. Examination of vehicles Vehicles entering a security restricted area shall be examined in order to prevent prohibited articles from being introduced into these areas. 1.5. Surveillance, patrols and other physical controls There shall be surveillance, patrols and other physical controls at airports and, where appropriate, in adjacent areas with public access, in order to identify suspicious behaviour of persons, to identify vulnerabilities which could be exploited to carry out an act of unlawful interference and to deter persons from committing such acts. 2. DEMARCATED AREAS OF AIRPORTS Aircraft parked in demarcated areas of airports to which alternative measures referred to in Article 4(4) apply, shall be separated from aircraft to which the common basic standards apply in full, in order to ensure that security standards applied to aircraft, passengers, baggage, cargo and mail of the latter are not compromised. 3. AIRCRAFT SECURITY 1. Before departure, an aircraft shall be subjected to an aircraft security check or aircraft security search in order to ensure that no prohibited articles are present on board. An aircraft in transit may be subjected to other appropriate measures. 2. Every aircraft shall be protected from unauthorised interference. 4. PASSENGERS AND CABIN BAGGAGE 4.1. Screening of passengers and cabin baggage 1. All originating, transfer and transit passengers and their cabin baggage shall be screened in order to prevent prohibited articles from being introduced into security restricted areas and on board an aircraft. 2. Transfer passengers and their cabin baggage may be exempted from screening, if: (a) they arrive from a Member State, unless the Commission or that Member State has provided information that those passengers and their cabin baggage cannot be considered as having been screened to the common basic standards; or (b) they arrive from a third country where the security standards applied are recognised as equivalent to the common basic standards in accordance with the regulatory procedure referred to in Article 19(2). 3. Transit passengers and their cabin baggage may be exempted from screening, if: (a) they remain on board the aircraft; or (b) they do not mix with screened departing passengers other than those who board the same aircraft; or (c) they arrive from a Member State, unless the Commission or that Member State has provided information that those passengers and their cabin baggage cannot be considered as having been screened to the common basic standards; or (d) they arrive from a third country where the security standards applied are recognised as equivalent to the common basic standards in accordance with the regulatory procedure referred to in Article 19(2). 4.2. Protection of passengers and cabin baggage 1. Passengers and their cabin baggage shall be protected from unauthorised interference from the point at which they are screened until departure of the aircraft on which they are carried. 2. Screened departing passengers shall not mix with arriving passengers, unless: (a) the passengers arrive from a Member State, provided that the Commission or that Member State has not provided information that those arriving passengers and their cabin baggage cannot be considered as having been screened to the common basic standards; or (b) the passengers arrive from a third country where the security standards applied are recognised as equivalent to the common basic standards in accordance with the regulatory procedure referred to in Article 19(2). 4.3. Potentially disruptive passengers Before departure potentially disruptive passengers shall be subjected to appropriate security measures. 5. HOLD BAGGAGE 5.1. Screening of hold baggage 1. All hold baggage shall be screened prior to being loaded onto an aircraft in order to prevent prohibited articles from being introduced into security restricted areas and on board aircraft. 2. Transfer hold baggage may be exempted from screening, if: (a) it arrives from a Member State, unless the Commission or that Member State has provided information that this hold baggage cannot be considered as having been screened to the common basic standards; or (b) it arrives from a third country where the security standards applied are recognised as equivalent to the common basic standards in accordance with the regulatory procedure referred to in Article 19(2). 3. Transit hold baggage may be exempted from screening if it remains on board the aircraft. 5.2. Protection of hold baggage Hold baggage to be carried on an aircraft shall be protected from unauthorised interference from the point at which it is screened or accepted into the care of the air carrier, whichever is earlier, until the departure of the aircraft on which it is to be carried. 5.3. Baggage reconciliation 1. Each item of hold baggage shall be identified as accompanied or unaccompanied. 2. Unaccompanied hold baggage shall not be transported, unless that baggage has been either separated due to factors beyond the passenger’s control or subjected to appropriate security controls. 6. CARGO AND MAIL 6.1. Security controls for cargo and mail 1. All cargo and mail shall be subjected to security controls prior to being loaded on an aircraft. An air carrier shall not accept cargo or mail for carriage on an aircraft unless it has applied such controls itself or their application has been confirmed and accounted for by a regulated agent, a known consignor or an account consignor. 2. Transfer cargo and transfer mail may be subjected to alternative security controls to be detailed in an implementing act. 3. Transit cargo and transit mail may be exempted from security controls if it remains on board the aircraft. 6.2. Protection of cargo and mail 1. Cargo and mail to be carried on an aircraft shall be protected from unauthorised interference from the point at which security controls are applied until the departure of the aircraft on which it is to be carried. 2. Cargo and mail that are not adequately protected from unauthorised interference after security controls have been applied shall be screened. 7. AIR CARRIER MAIL AND AIR CARRIER MATERIALS Air carrier mail and air carrier materials shall be subjected to security controls and thereafter protected until loaded onto the aircraft in order to prevent prohibited articles from being introduced on board an aircraft. 8. IN-FLIGHT SUPPLIES In-flight supplies, including catering, intended for carriage or use on board an aircraft shall be subjected to security controls and thereafter protected until loaded onto the aircraft in order to prevent prohibited articles from being introduced on board an aircraft. 9. AIRPORT SUPPLIES Supplies intended to be sold or used in security restricted areas of airports, including supplies for duty-free shops and restaurants, shall be subjected to security controls in order to prevent prohibited articles from being introduced into these areas. 10. IN-FLIGHT SECURITY MEASURES 1. Without prejudice to the applicable aviation safety rules: (a) unauthorised persons shall be prevented from entering the flight crew compartment during a flight; (b) potentially disruptive passengers shall be subjected to appropriate security measures during a flight. 2. Appropriate security measures such as training of flight crew and cabin staff shall be taken to prevent acts of unlawful interference during a flight. 3. Weapons, with the exception of those carried in the hold, shall not be carried on board an aircraft, unless the required security conditions in accordance with national laws have been fulfilled and authorisation has been given by the states involved. 4. Paragraph 3 shall also apply to in-flight security officers if they carry weapons. 11. STAFF RECRUITMENT AND TRAINING 1. Persons implementing, or responsible for implementing, screening, access control or other security controls shall be recruited, trained and, where appropriate, certified so as to ensure that they are suitable for employment and competent to undertake the duties to which they are assigned. 2. Persons other than passengers requiring access to security restricted areas shall receive security training, before either an airport identification card or crew identification card is issued. 3. Training as mentioned in paragraphs 1 and 2 shall be conducted on initial and recurrent basis. 4. Instructors engaged in the training of the persons mentioned in paragraphs 1 and 2 shall have the necessary qualifications. 12. SECURITY EQUIPMENT Equipment used for screening, access control and other security controls shall comply with the defined specifications and be capable of performing the security controls concerned.

Civil aviation security: EU-wide rules Civil aviation security: EU-wide rules SUMMARY OF: Regulation (EC) No 300/2008 on common rules in the field of civil aviation security WHAT IS THE AIM OF THE REGULATION? It lays down common rules and basic standards on aviation security and on procedures to monitor their implementation. It applies to all civil airports in the EU, as well as to air carriers and other persons or businesses providing goods or services to or through these airports. It replaces Regulation (EC) No 2320/2002 which was adopted in the wake of the 11 September 2001 events and which established common rules in the field of civil aviation security. KEY POINTS Common basic standards for protecting civil aviation These standards include, for example: screening of passengers and cabin baggage to stop prohibited articles, such as weapons and explosives, being carried on board aircraft; the hold luggage (luggage that passengers check in) is also screened before loading; airport security (e.g. controlled access to different areas of airports, staff screening and checking of vehicles, as well as surveillance and patrols to prevent unauthorised people from entering these areas); protection of aircraft and aircraft security checks or searches before departure to ensure that no prohibited articles are on board; security controls for cargo and mail before being loaded on to aircraft; security controls for airport supplies (i.e. supplies intended to be sold in duty-free shops and restaurants) and in-flight supplies (e.g. food and drink for passengers); staff recruitment and training; security equipment performance (i.e. equipment used for screening and access controls complies with defined specifications and is capable of performing the security controls concerned). In November 2015, the European Commission adopted Implementing Regulation (EU) 2015/1998. It lays down detailed measures for the implementation of these security standards and repealed a previous regulation (Regulation (EU) No 185/2010) which had been amended more than 20 times. Since its adoption, Implementing Regulation (EU) 2015/1998 has itself been amended several times. The amendments modify the list of non-EU countries recognised as applying equivalent standards to those of the EU, and introduce new rules regarding: airport security; aircraft security; screening of liquids, aerosols and gels, hold baggage, cargo and mail, in-flight supplies; staff recruitment and training; security equipment; background checks to enhance security culture and resilience; performance standards; the use of shoe explosive detection equipment and explosive vapour detection equipment. Obligations on EU countries and on airports and operators EU countries must: designate a single authority responsible for aviation security; set up a national civil aviation security programme to define responsibilities for implementing the common basic standards; set up a national quality control programme to check the quality of civil aviation security. Airports, air carriers and entities must: define and implement a security programme; ensure internal quality control. Commission inspections The Commission carries out inspections in cooperation with national authorities including unannounced inspections of airports, air carriers and other relevant persons or businesses. Any shortcomings must be remedied by the national authority. National authorities are responsible for primary quality control and enforcement, and therefore must carry out audits and inspections of airports, air carriers and other relevant persons or businesses. Recognition of equivalent aviation security standards with non-EU countries The EU may recognise non-EU countries’ aviation security standards as equivalent to EU standards to allow a ‘one-stop security’ system. This means, for example, that passengers arriving at EU airports and transferring to other destinations would no longer need to be re-screened. This would result in faster connection times, lower costs and greater convenience for travellers. ‘One-stop security’ is one of the objectives of EU aviation security legislation. Implementation reports Every year, the Commission publishes a report on the implementation of Regulation (EC) No 300/2008. The latest report, relating to 2017, was published in 2019. COVID-19 pandemic The COVID-19 pandemic severely limits the capability of EU countries and the EU as a whole to maintain an effective and efficient in-bound supply chain. Continued and uninterrupted cargo services are of essential strategic importance for the Union and play a fundamental role in the delivery of essential goods, including medicines, medical equipment, other substances and commodities. Implementing Regulation (EU) 2020/910 therefore amends Regulation (EU) 2015/1998 as regards re-designating airlines, operators and entities providing security controls for cargo and mail arriving from non-EU countries, as well as postponing certain regulatory requirements. The Annex to Regulation (EU) 2015/1998 is amended to take account of factors such as the pandemic’s impact on the performance of on-site installations, checks and visits, and the need to adopt urgent measures establishing the appropriate legal basis to implement an alternative and expedite process for the EU aviation security validations of EU-bound supply chain operators affected. FROM WHEN DOES THE REGULATION APPLY? It has applied since 28 April 2010 The following articles have applied since 29 April 2008: Articles 4(2), 4(3), 4(4), all of which relate to common basic standards except those relating to safeguarding civil aviation against acts of unlawful interference; Article 8 on cooperation with the International Civil Aviation Organisation; Article 11(2): specifications for national quality control programmes; Article 15(1) second subparagraph: unannounced inspections by the Commission; Article 17: Stakeholders’ Advisory Group; Article 19: Committee procedure; and Article 21: penalties. BACKGROUND For more information, see: Aviation Security (European Commission). MAIN DOCUMENT Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, pp. 72-84) Successive amendments to Regulation (EC) No 300/2008 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Implementing Regulation (EU) 2020/910 of 30 June 2020 amending Implementing Regulations (EU) 2015/1998, (EU) 2019/103 and (EU) 2019/1583 as regards the re-designation of airlines, operators and entities providing security controls for cargo and mail arriving from third countries, as well as the postponement of certain regulatory requirements in the area of cybersecurity, background check, explosive detection systems equipment standards, and explosive trace detection equipment, because of the COVID-19 pandemic (OJ L 208, 1.7.2020, pp. 43-47) Commission Implementing Regulation (EU) 2015/1998 of 5 November 2015 laying down detailed measures for the implementation of the common basic standards on aviation security (OJ L 299, 14.11.2015, pp. 1-142) See consolidated version. Commission Regulation (EU) No 72/2010 of 26 January 2010 laying down procedures for conducting Commission inspections in the field of aviation security (OJ L 23, 27.1.2010, pp. 1-5) See consolidated version. Commission Regulation (EU) No 1254/2009 of 18 December 2009 setting criteria to allow Member States to derogate from the common basic standards on civil aviation security and to adopt alternative security measures (OJ L 338, 19.12.2009, p. 17) See consolidated version. Commission Regulation (EC) No 272/2009 of 2 April 2009 supplementing the common basic standards on civil aviation security laid down in the Annex to Regulation (EC) No 300/2008 of the European Parliament and of the Council (OJ L 91, 3.4.2009, pp. 7-13) See consolidated version. Report from the Commission to the European Parliament and the Council — 2017 annual report on the implementation of Regulation (EC) No 300/2008 on common rules in the field of civil aviation security (COM(2019) 183 final, 16.4.2019) last update 14.09.2020

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13.8.2008 EN Official Journal of the European Union L 218/30 REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Articles 95 and 133 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) It is necessary to ensure that products benefiting from the free movement of goods within the Community fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety at the workplace, protection of consumers, protection of the environment and security, while ensuring that the free movement of products is not restricted to any extent greater than that which is allowed under Community harmonisation legislation or any other relevant Community rules. Provision should, therefore, be made for rules on accreditation, market surveillance, controls of products from third countries and the CE marking. (2) It is necessary to establish an overall framework of rules and principles in relation to accreditation and market surveillance. That framework should not affect the substantive rules of existing legislation setting out the provisions to be observed for the purpose of protecting public interests such as health, safety and protection of consumers and of the environment, but should aim at enhancing their operation. (3) This Regulation should be seen as complementary to Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products (3). (4) It is very difficult to adopt Community legislation for every product which exists or which may be developed; there is a need for a broad-based, legislative framework of a horizontal nature to deal with such products, to cover lacunae, in particular pending revision of existing specific legislation, and to complement provisions in existing or future specific legislation, in particular with a view to ensuring a high level of protection of health, safety, the environment and consumers, as required by Article 95 of the Treaty. (5) The framework for market surveillance established by this Regulation should complement and strengthen existing provisions in Community harmonisation legislation relating to market surveillance and the enforcement of such provisions. However, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in other existing or future rules of Community harmonisation legislation. Examples can be found in the following sectors: drug precursors, medical devices, medicinal products for human and veterinary use, motor vehicles and aviation. The corresponding provisions of this Regulation should not therefore apply in the areas covered by such specific provisions. (6) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (4) established rules to ensure the safety of consumer products. Market surveillance authorities should have the possibility of taking the more specific measures available to them under that Directive. (7) However, in order to achieve a higher level of safety for consumer products, the market surveillance mechanisms provided for in Directive 2001/95/EC should be reinforced as regards products presenting a serious risk, in accordance with the principles established by this Regulation. Directive 2001/95/EC should therefore be amended accordingly. (8) Accreditation is part of an overall system, including conformity assessment and market surveillance, designed to assess and ensure conformity with the applicable requirements. (9) The particular value of accreditation lies in the fact that it provides an authoritative statement of the technical competence of bodies whose task is to ensure conformity with the applicable requirements. (10) Accreditation, though so far not regulated at Community level, is carried out in all Member States. The lack of common rules for that activity has resulted in different approaches and differing systems throughout the Community, with the result that the degree of rigour applied in the performance of accreditation has varied between Member States. It is therefore necessary to develop a comprehensive framework for accreditation and to lay down at Community level the principles for its operation and organisation. (11) The establishment of a uniform national accreditation body should be without prejudice to the allocation of functions within Member States. (12) Where Community harmonisation legislation provides for the selection of conformity assessment bodies for its implementation, transparent accreditation, as provided for in this Regulation, ensuring the necessary level of confidence in conformity certificates, should be considered by the national public authorities throughout the Community the preferred means of demonstrating the technical competence of those bodies. However, national authorities may consider that they possess the appropriate means of carrying out this evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements. (13) A system of accreditation which functions by reference to binding rules helps to strengthen mutual confidence between Member States as regards the competence of conformity assessment bodies and consequently the certificates and test reports issued by them. It thereby enhances the principle of mutual recognition and therefore the provisions of this Regulation on accreditation should apply in relation to bodies carrying out conformity assessments in both the regulated and the non-regulated areas. The issue at stake is the quality of certificates and test reports irrespective of whether they fall within the regulated or the non-regulated area, and no distinction should therefore be made between those areas. (14) For the purposes of this Regulation, not-for-profit operation by a national accreditation body should be understood as an activity that is not intended to add any gain to the resources of the body's owners or members. While national accreditation bodies do not have the objective of maximising or distributing profits, they may provide services in return for payment, or receive income. Any excess revenue that results from such services may be used for investment to develop their activities further, as long as it is in line with their main activities. It should accordingly be emphasised that the primary objective of national accreditation bodies should be to support or engage actively in activities that are not intended to produce any gain. (15) Since the purpose of accreditation is to provide an authoritative statement of the competence of a body to perform conformity assessment activities, Member States should not maintain more than one national accreditation body and should ensure that that body is organised in such a way as to safeguard the objectivity and impartiality of its activities. Such national accreditation bodies should operate independently of commercial conformity assessment activities. It is therefore appropriate to provide that Member States ensure that, in the performance of their tasks, national accreditation bodies are deemed to exercise public authority, irrespective of their legal status. (16) For the assessment and continued monitoring of the competence of a conformity assessment body, it is essential to determine its technological knowledge and experience and its ability to carry out assessment. It is therefore necessary that the national accreditation body possess the relevant knowledge, competence and means for the proper performance of its tasks. (17) Accreditation should in principle be operated as a self-supporting activity. Member States should ensure that financial support exists for the fulfilment of special tasks. (18) In those cases where it is not economically meaningful or sustainable for a Member State to establish a national accreditation body, that Member State should have recourse to the national accreditation body of another Member State and should be encouraged to have such recourse to the fullest extent possible. (19) Competition between national accreditation bodies could lead to the commercialisation of their activity, which would be incompatible with their role as the last level of control in the conformity assessment chain. The objective of this Regulation is to ensure that, within the European Union, one accreditation certificate is sufficient for the whole territory of the Union, and to avoid multiple accreditation, which is added cost without added value. National accreditation bodies may find themselves in competition on the markets of third countries, but that must have no effect on their activities inside the Community, or on the cooperation and peer evaluation activities organised by the body recognised under this Regulation. (20) In order to avoid multiple accreditation, to enhance acceptance and recognition of accreditation certificates and to carry out effective monitoring of accredited conformity assessment bodies, conformity assessment bodies should request accreditation by the national accreditation body of the Member State in which they are established. Nevertheless, it is necessary to ensure that a conformity assessment body is able to request accreditation in another Member State in the event that there is no national accreditation body in its own Member State or where the national accreditation body is not competent to provide the accreditation services requested. In such cases, appropriate cooperation and exchange of information between national accreditation bodies should be established. (21) In order to ensure that national accreditation bodies fulfil the requirements and obligations provided for in this Regulation, it is important that Member States support the proper functioning of the accreditation system, monitor their national accreditation bodies regularly and take appropriate corrective measures within a reasonable timeframe where necessary. (22) In order to ensure the equivalence of the level of competence of conformity assessment bodies, to facilitate mutual recognition and to promote the overall acceptance of accreditation certificates and conformity assessment results issued by accredited bodies, it is necessary that national accreditation bodies operate a rigorous and transparent peer evaluation system and regularly undergo such evaluation. (23) This Regulation should provide for the recognition of a single organisation at European level in respect of certain functions in the field of accreditation. The European cooperation for Accreditation (the EA), whose main mission is to promote a transparent and quality-led system for the evaluation of the competence of conformity assessment bodies throughout Europe, manages a peer evaluation system among national accreditation bodies from the Member States and other European countries. That system has proved to be efficient and to provide mutual confidence. The EA should, therefore, be the first body recognised under this Regulation and Member States should ensure that their national accreditation bodies seek and maintain membership of the EA for as long as it is so recognised. At the same time, the possibility of changing the relevant body recognised under this Regulation should be provided for, in case there is a need for it in the future. (24) Effective cooperation among national accreditation bodies is essential for the proper implementation of peer evaluation and with regard to cross-border accreditation. In the interests of transparency, it is, therefore, necessary to provide for an obligation on national accreditation bodies to exchange information among themselves and to provide the national authorities and the Commission with relevant information. Updated and accurate information concerning the availability of accreditation activities operated by national accreditation bodies should also be made public and, therefore, accessible, in particular to conformity assessment bodies. (25) Sectoral accreditation schemes should cover the fields of activity where general requirements for the competence of conformity assessment bodies are not sufficient to ensure the necessary level of protection where specific detailed technology or health and safety-related requirements are imposed. Given the fact that the EA has at its disposal a broad range of technical expertise, it should be requested to develop such schemes, especially for areas covered by Community legislation. (26) For the purpose of ensuring the equivalent and consistent enforcement of Community harmonisation legislation, this Regulation introduces a Community market surveillance framework, defining minimum requirements against the background of the objectives to be achieved by Member States and a framework for administrative cooperation including the exchange of information among Member States. (27) In the case of economic operators in possession of test reports or certificates attesting conformity issued by an accredited conformity assessment body, where the relevant Community harmonisation legislation does not require such reports or certificates, market surveillance authorities should take due account of them when performing checks on product characteristics. (28) Cooperation between competent authorities at national level and across borders in exchanging information, investigating infringements and taking action to bring about their cessation, even before the placing on the market of dangerous products, by reinforcing measures to identify them, mainly in seaports, is essential to the protection of health and safety and to guaranteeing the smooth functioning of the internal market. National consumer protection authorities should cooperate, at national level, with national market surveillance authorities and should exchange information with them relating to products which they suspect present a risk. (29) Risk assessment should take all relevant data into account, including, where available, data on risks that have materialised with respect to the product in question. Account should also be taken of any measures that may have been taken by the economic operators concerned to alleviate the risks. (30) Situations of serious risk posed by a product require rapid intervention, which may entail the withdrawal of the product, its recall or the prohibition of its being made available on the market. In those situations it is necessary to have access to a system of rapid exchange of information between Member States and the Commission. The system provided for in Article 12 of Directive 2001/95/EC has proved its effectiveness and efficiency in the field of consumer products. To avoid unnecessary duplication, that system should be used for the purposes of this Regulation. Moreover, coherent market surveillance throughout the Community requires a comprehensive exchange of information on national activities in this context which goes beyond this system. (31) Information exchanged between competent authorities should be subject to the strictest guarantees of confidentiality and professional secrecy and be handled in accordance with rules on confidentiality pursuant to the applicable national law or, as regards the Commission, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (5), in order to ensure that investigations are not compromised and that the reputations of economic operators are not prejudiced. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (6) and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (7) apply in the context of this Regulation. (32) Community harmonisation legislation provides for specific procedures establishing whether or not a national measure restricting the free movement of a product is justified (safeguard clause procedures). Those procedures apply following a rapid exchange of information on products presenting a serious risk. (33) Points of entry at the external borders are well placed to detect unsafe non-conforming products or products to which the CE marking has been affixed falsely or in a misleading manner even before they are placed on the market. An obligation on authorities in charge of the control of products entering the Community market to execute checks on an adequate scale can therefore contribute to a safer market place. In order to increase the effectiveness of such checks, those authorities should receive all the necessary information concerning dangerous non-conforming products from the market surveillance authorities well in advance. (34) Council Regulation (EEC) No 339/93 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries (8) lays down rules regarding the suspension of the release of products by customs authorities and provides for further measures including the involvement of market surveillance authorities. It is therefore appropriate that those provisions, including the involvement of market surveillance authorities, be incorporated in this Regulation. (35) Experience has shown that products which are not released are often re-exported and subsequently enter the Community market at other points of entry, thus undermining the customs authorities' efforts. Market surveillance authorities should therefore be given the means of proceeding with the destruction of products if they deem it appropriate. (36) Within one year of the publication of this Regulation in the Official Journal of the European Union, the Commission should present an in-depth analysis in the realm of consumer safety markings, followed by legislative proposals where necessary. (37) The CE marking, indicating the conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking should be set out in this Regulation so as to make them immediately applicable and to simplify future legislation. (38) The CE marking should be the only marking of conformity indicating that a product is in conformity with Community harmonisation legislation. However, other markings may be used as long as they contribute to the improvement of consumer protection and are not covered by Community harmonisation legislation. (39) It is necessary for Member States to provide for appropriate means of redress in the competent courts and tribunals in respect of measures taken by the competent authorities which restrict the placing on the market of a product or which require its withdrawal or recall. (40) Member States may find it useful to establish cooperation with the stakeholders concerned, including sectoral professional organisations and consumer organisations, in order to take advantage of available market intelligence when establishing, implementing and updating market surveillance programmes. (41) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive and could be increased if the relevant economic operator has previously committed a similar infringement of the provisions of this Regulation. (42) In order to achieve the objectives of this Regulation, it is necessary for the Community to contribute to the financing of activities required to implement policies in the field of accreditation and market surveillance. Financing should be provided in the form of grants to the body recognised under this Regulation without a call for proposals, in the form of grants after a call for proposals, or by the award of contracts to that or to other bodies, depending on the nature of the activity to be financed and in accordance with Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (9) (the Financial Regulation). (43) For some specialised tasks, such as the production and revision of sectoral accreditation schemes, and for other tasks related to the verification of the technical competence and the facilities of laboratories and certification or inspection bodies, the EA should initially be eligible for Community financing, since it is well adapted to providing the necessary technical expertise in this respect. (44) Given the role of the body recognised under this Regulation in the peer evaluation of accreditation bodies and its ability to assist the Member States with the management of that peer evaluation, the Commission should be in a position to provide grants for the functioning of the secretariat of the body recognised under this Regulation, which should provide ongoing support for accreditation activities at Community level. (45) A partnership agreement should be signed, in accordance with the provisions of the Financial Regulation, between the Commission and the body recognised under this Regulation in order to fix the administrative and financial rules on the financing of accreditation activities. (46) In addition, financing should also be available to bodies other than the body recognised under this Regulation for other activities in the field of conformity assessment, metrology, accreditation and market surveillance, such as the drawing-up and updating of guidelines, inter-comparison activities linked to the operation of safeguard clauses, preliminary or ancillary activities in connection with the implementation of Community legislation in those areas and programmes of technical assistance and cooperation with third countries as well as the enhancement of policies in those areas at Community and international level. (47) This Regulation respects the fundamental rights and observes the principles reflected in the Charter of Fundamental Rights of the European Union. (48) Since the objective of this Regulation, namely to ensure that products on the market covered by Community legislation fulfil requirements providing a high level of protection of health and safety and other public interests while guaranteeing the functioning of the internal market by providing a framework for accreditation and market surveillance, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities. 2. This Regulation provides a framework for the market surveillance of products to ensure that those products fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety at the workplace, the protection of consumers, protection of the environment and security. 3. This Regulation provides a framework for controls on products from third countries. 4. This Regulation lays down the general principles of the CE marking. Article 2 Definitions For the purposes of this Regulation the following definitions shall apply: 1. ‘making available on the market’ shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge; 2. ‘placing on the market’ shall mean the first making available of a product on the Community market; 3. ‘manufacturer’ shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark; 4. ‘authorised representative’ shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under the relevant Community legislation; 5. ‘importer’ shall mean any natural or legal person established within the Community who places a product from a third country on the Community market; 6. ‘distributor’ shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market; 7. ‘economic operators’ shall mean the manufacturer, the authorised representative, the importer and the distributor; 8. ‘technical specification’ shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service; 9. ‘harmonised standard’ shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (10) on the basis of a request made by the Commission in accordance with Article 6 of that Directive; 10. ‘accreditation’ shall mean an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity; 11. ‘national accreditation body’ shall mean the sole body in a Member State that performs accreditation with authority derived from the State; 12. ‘conformity assessment’ shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled; 13. ‘conformity assessment body’ shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection; 14. ‘recall’ shall mean any measure aimed at achieving the return of a product that has already been made available to the end user; 15. ‘withdrawal’ shall mean any measure aimed at preventing a product in the supply chain from being made available on the market; 16. ‘peer evaluation’ shall mean a process for the assessment of a national accreditation body by other national accreditation bodies, carried out in accordance with the requirements of this Regulation, and, where applicable, additional sectoral technical specifications; 17. ‘market surveillance’ shall mean the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection; 18. ‘market surveillance authority’ shall mean an authority of a Member State responsible for carrying out market surveillance on its territory; 19. ‘release for free circulation’ shall mean the procedure laid down in Article 79 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (11); 20. ‘CE marking’ shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing; 21. ‘Community harmonisation legislation’ shall mean any Community legislation harmonising the conditions for the marketing of products. CHAPTER II ACCREDITATION Article 3 Scope This Chapter shall apply to accreditation, used on a compulsory or voluntary basis, relating to conformity assessment, whether that assessment is compulsory or not, and irrespective of the legal status of the body performing the accreditation. Article 4 General principles 1. Each Member State shall appoint a single national accreditation body. 2. Where a Member State considers that it is not economically meaningful or sustainable to have a national accreditation body or to provide certain accreditation services, it shall, as far as possible, have recourse to the national accreditation body of another Member State. 3. A Member State shall inform the Commission and the other Member States where, in accordance with paragraph 2, recourse is had to the national accreditation body of another Member State. 4. On the basis of the information referred to in paragraph 3 and Article 12, the Commission shall draw up and update a list of national accreditation bodies which it shall make publicly available. 5. Where accreditation is not operated directly by the public authorities themselves, a Member State shall entrust its national accreditation body with the operation of accreditation as a public authority activity and grant it formal recognition. 6. The responsibilities and tasks of the national accreditation body shall be clearly distinguished from those of other national authorities. 7. The national accreditation body shall operate on a not-for-profit basis. 8. The national accreditation body shall not offer or provide any activities or services that conformity assessment bodies provide, nor shall it provide consultancy services, own shares in or otherwise have a financial or managerial interest in a conformity assessment body. 9. Each Member State shall ensure that its national accreditation body has the appropriate financial and personnel resources for the proper performance of its tasks, including the fulfilment of special tasks, such as activities for European and international accreditation cooperation and activities that are required to support public policy and which are not self-financing. 10. The national accreditation body shall be a member of the body recognised under Article 14. 11. National accreditation bodies shall establish and maintain appropriate structures to ensure the effective and balanced involvement of all interested parties within both their organisations and the body recognised under Article 14. Article 5 Operation of accreditation 1. A national accreditation body shall, when requested by a conformity assessment body, evaluate whether that conformity assessment body is competent to carry out a specific conformity assessment activity. Where it is found to be competent, the national accreditation body shall issue an accreditation certificate to that effect. 2. When a Member State decides not to use accreditation, it shall provide the Commission and the other Member States with all the documentary evidence necessary for the verification of the competence of the conformity assessment bodies it selects for the implementation of the Community harmonisation legislation in question. 3. National accreditation bodies shall monitor the conformity assessment bodies to which they have issued an accreditation certificate. 4. Where a national accreditation body ascertains that a conformity assessment body which has received an accreditation certificate is no longer competent to carry out a specific conformity assessment activity or has committed a serious breach of its obligations, that accreditation body shall take all appropriate measures within a reasonable timeframe to restrict, suspend or withdraw the accreditation certificate. 5. Member States shall establish procedures for the resolution of appeals, including, where appropriate, legal remedies against accreditation decisions or the absence thereof. Article 6 Principle of non-competition 1. National accreditation bodies shall not compete with conformity assessment bodies. 2. National accreditation bodies shall not compete with other national accreditation bodies. 3. National accreditation bodies shall be permitted to operate across national borders, within the territory of another Member State, either at the request of a conformity assessment body in the circumstances set out in Article 7(1), or, if they are asked to do so by a national accreditation body in accordance with Article 7(3), in cooperation with the national accreditation body of that Member State. Article 7 Cross-border accreditation 1. Where a conformity assessment body requests accreditation it shall do so with the national accreditation body of the Member State in which it is established or with the national accreditation body to which that Member State has had recourse in accordance with Article 4(2). However, a conformity assessment body may request accreditation by a national accreditation body other than those referred to in the first subparagraph in any one of the following situations: (a) where the Member State in which it is established has decided not to establish a national accreditation body and has not had recourse to the national accreditation body of another Member State in accordance with Article 4(2); (b) where the national accreditation bodies referred to in the first subparagraph do not perform accreditation in respect of the conformity assessment activities for which accreditation is sought; (c) where the national accreditation bodies referred to in the first subparagraph have not successfully undergone peer evaluation under Article 10 in respect of the conformity assessment activities for which accreditation is sought. 2. Where a national accreditation body receives a request pursuant to paragraph 1(b) or (c), it shall inform the national accreditation body of the Member State in which the requesting conformity assessment body is established. In such cases, the national accreditation body of the Member State in which the requesting conformity assessment body is established may participate as an observer. 3. A national accreditation body may request another national accreditation body to carry out part of the assessment activity. In such a case, the accreditation certificate shall be issued by the requesting body. Article 8 Requirements for national accreditation bodies A national accreditation body shall fulfil the following requirements: 1. it shall be organised in such a manner as to make it independent of the conformity assessment bodies it assesses and of commercial pressures, and to ensure that no conflicts of interest with conformity assessment bodies occur; 2. it shall be organised and operated so as to safeguard the objectivity and impartiality of its activities; 3. it shall ensure that each decision relating to the attestation of competence is taken by competent persons different from those who carried out the assessment; 4. it shall have adequate arrangements to safeguard the confidentiality of the information obtained; 5. it shall identify the conformity assessment activities for which it is competent to perform accreditation, referring, where appropriate, to relevant Community or national legislation and standards; 6. it shall set up the procedures necessary to ensure efficient management and appropriate internal controls; 7. it shall have a number of competent personnel at its disposal sufficient for the proper performance of its tasks; 8. it shall document the duties, responsibilities and authorities of personnel who could affect the quality of the assessment and of the attestation of competence; 9. it shall establish, implement and maintain procedures for monitoring the performance and competence of the personnel involved; 10. it shall verify that conformity assessments are carried out in an appropriate manner, meaning that unnecessary burdens are not imposed on undertakings and that due account is taken of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process; 11. it shall publish audited annual accounts prepared in accordance with generally accepted accounting principles. Article 9 Compliance with requirements 1. Where a national accreditation body does not meet the requirements of this Regulation or fails to fulfil its obligations hereunder, the Member State concerned shall take appropriate corrective action or shall ensure that such corrective action is taken, and shall inform the Commission thereof. 2. Member States shall monitor their national accreditation bodies at regular intervals in order to ensure that they fulfil the requirements laid down in Article 8 on a continuing basis. 3. Member States shall take the utmost account of the results of peer evaluation under Article 10 when carrying out the monitoring referred to in paragraph 2 of this Article. 4. National accreditation bodies shall have in place the necessary procedures to deal with complaints against the conformity assessment bodies they have accredited. Article 10 Peer evaluation 1. National accreditation bodies shall subject themselves to peer evaluation organised by the body recognised under Article 14. 2. Stakeholders shall have the right to participate in the system set up for the supervision of peer evaluation activities, but not in individual peer evaluation procedures. 3. Member States shall ensure that their national accreditation bodies regularly undergo peer evaluation as required by paragraph 1. 4. Peer evaluation shall be operated on the basis of sound and transparent evaluation criteria and procedures, in particular concerning structural, human resource and process requirements, confidentiality and complaints. Appropriate appeal procedures against decisions taken as a result of such evaluation shall be provided for. 5. Peer evaluation shall ascertain whether the national accreditation bodies meet the requirements laid down in Article 8, taking into account the relevant harmonised standards referred to in Article 11. 6. The outcome of peer evaluation shall be published and communicated by the body recognised under Article 14 to all Member States and the Commission. 7. The Commission shall, in cooperation with the Member States, oversee the rules and the proper functioning of the peer evaluation system. Article 11 Presumption of conformity for national accreditation bodies 1. National accreditation bodies that demonstrate conformity with the criteria laid down in the relevant harmonised standard, the reference of which has been published in the Official Journal of the European Union, by having successfully undergone peer evaluation under Article 10 shall be presumed to fulfil the requirements laid down in Article 8. 2. National authorities shall recognise the equivalence of the services delivered by those accreditation bodies which have successfully undergone peer evaluation under Article 10, and thereby accept, on the basis of the presumption referred to in paragraph 1 of this Article, the accreditation certificates of those bodies and the attestations issued by the conformity assessment bodies accredited by them. Article 12 Information obligation 1. Each national accreditation body shall inform the other national accreditation bodies of the conformity assessment activities in respect of which it operates accreditation and of any changes thereto. 2. Each Member State shall inform the Commission and the body recognised under Article 14 of the identity of its national accreditation body and of all conformity assessment activities in respect of which that body operates accreditation in support of Community harmonisation legislation, and of any changes thereto. 3. Each national accreditation body shall regularly make publicly available information concerning the results of its peer evaluation, the conformity assessment activities in respect of which it operates accreditation and any changes thereto. Article 13 Requests to the body recognised under Article 14 1. The Commission may, after consulting the Committee set up by Article 5 of Directive 98/34/EC, request the body recognised under Article 14 to contribute to the development, maintenance and implementation of accreditation in the Community. 2. The Commission may also, following the procedure laid down in paragraph 1: (a) request the body recognised under Article 14 to lay down evaluation criteria and procedures for peer evaluation and to develop sectoral accreditation schemes; (b) accept any existing scheme that already lays down evaluation criteria and procedures for peer evaluation. 3. The Commission shall ensure that sectoral schemes identify the technical specifications necessary to meet the level of competence required by Community harmonisation legislation in fields with specific requirements relating to technology, health and safety or environment related requirements or any other aspect of public interest protection. Article 14 European accreditation infrastructure 1. The Commission shall, after consulting the Member States, recognise a body which satisfies the requirements set out in Annex I to this Regulation. 2. A body which is to be recognised pursuant to paragraph 1 shall conclude an agreement with the Commission. That agreement shall specify, inter alia, the detailed tasks of the body, funding provisions and provisions for its supervision. Both the Commission and the body shall be able to terminate the agreement without cause at the expiry of a reasonable period of notice to be defined therein. 3. The Commission and the body shall make the agreement public. 4. The Commission shall communicate the recognition of a body pursuant to paragraph 1 to the Member States and to national accreditation bodies. 5. The Commission may not recognise more than one body at a time. 6. The first body recognised under this Regulation shall be the European cooperation for accreditation, provided that it has concluded an agreement as specified in paragraph 2. CHAPTER III COMMUNITY MARKET SURVEILLANCE FRAMEWORK AND CONTROLS OF PRODUCTS ENTERING THE COMMUNITY MARKET SECTION 1 General provisions Article 15 Scope 1. Articles 16 to 26 shall apply to products covered by Community harmonisation legislation. 2. Each of the provisions of Articles 16 to 26 shall apply in so far as there are no specific provisions with the same objective in Community harmonisation legislation. 3. The application of this Regulation shall not prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC. 4. For the purposes of Articles 16 to 26, a ‘product’ shall mean a substance, preparation or good produced through a manufacturing process other than food, feed, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction. 5. Articles 27, 28 and 29 shall apply to all products covered by Community legislation in so far as other Community legislation does not contain specific provisions relating to the organisation of border controls. Article 16 General requirements 1. Member States shall organise and carry out market surveillance as provided for in this Chapter. 2. Market surveillance shall ensure that products covered by Community harmonisation legislation which, when used in accordance with their intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in Community harmonisation legislation are withdrawn or their being made available on the market is prohibited or restricted and that the public, the Commission and the other Member States are informed accordingly. 3. National market surveillance infrastructures and programmes shall ensure that effective measures can be taken in relation to any product category subject to Community harmonisation legislation. 4. Market surveillance shall cover products assembled or manufactured for the manufacturer's own use where Community harmonisation legislation provides that its provisions shall apply to such products. SECTION 2 Community market surveillance framework Article 17 Information obligations 1. Member States shall inform the Commission of their market surveillance authorities and their areas of competence. The Commission shall transmit that information to the other Member States. 2. Member States shall ensure that the public is aware of the existence, responsibilities and identity of national market surveillance authorities, and of how those authorities may be contacted. Article 18 Obligations of the Member States as regards organisation 1. Member States shall establish appropriate communication and coordination mechanisms between their market surveillance authorities. 2. Member States shall establish adequate procedures in order to: (a) follow up complaints or reports on issues relating to risks arising in connection with products subject to Community harmonisation legislation; (b) monitor accidents and harm to health which are suspected to have been caused by those products; (c) verify that corrective action has been taken; and (d) follow up scientific and technical knowledge concerning safety issues. 3. Member States shall entrust market surveillance authorities with the powers, resources and knowledge necessary for the proper performance of their tasks. 4. Member States shall ensure that market surveillance authorities exercise their powers in accordance with the principle of proportionality. 5. Member States shall establish, implement and periodically update their market surveillance programmes. Member States shall draw up either a general market surveillance programme or sector specific programmes, covering the sectors in which they conduct market surveillance, communicate those programmes to the other Member States and the Commission and make them available to the public, by way of electronic communication and, where appropriate, by other means. The first such communication shall be effected by 1 January 2010. Subsequent updates of the programmes shall be made public in the same manner. Member States may cooperate with all relevant stakeholders to those ends. 6. Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every fourth year and the results thereof shall be communicated to the other Member States and the Commission and be made available to the public, by way of electronic communication and, where appropriate, by other means. Article 19 Market surveillance measures 1. Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks on the basis of adequate samples. When doing so they shall take account of established principles of risk assessment, complaints and other information. Market surveillance authorities may require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities, and, where it is necessary and justified, enter the premises of economic operators and take the necessary samples of products. They may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary. Where economic operators present test reports or certificates attesting conformity issued by an accredited conformity assessment body, market surveillance authorities shall take due account of such reports or certificates. 2. Market surveillance authorities shall take appropriate measures to alert users within their territories within an adequate timeframe of hazards they have identified relating to any product so as to reduce the risk of injury or other damage. They shall cooperate with economic operators regarding actions which could prevent or reduce risks caused by products made available by those operators. 3. Where the market surveillance authorities of one Member State decide to withdraw a product manufactured in another Member State, they shall inform the economic operator concerned at the address indicated on the product in question or in the documentation accompanying that product. 4. Market surveillance authorities shall carry out their duties independently, impartially and without bias. 5. Market surveillance authorities shall observe confidentiality where necessary in order to protect commercial secrets or to preserve personal data pursuant to national legislation, subject to the requirement that information be made public under this Regulation to the fullest extent necessary in order to protect the interests of users in the Community. Article 20 Products presenting a serious risk 1. Member States shall ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on their market is prohibited, and that the Commission is informed without delay thereof, in accordance with Article 22. 2. The decision whether or not a product represents a serious risk shall be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk. Article 21 Restrictive measures 1. Member States shall ensure that any measure taken, pursuant to the relevant Community harmonisation legislation, to prohibit or restrict the product's being made available on the market, to withdraw it from the market or to recall it, is proportionate and states the exact grounds on which it is based. 2. Such measures shall be communicated without delay to the relevant economic operator, which shall at the same time be informed of the remedies available under the law of the Member State concerned and of the time limits to which such remedies are subject. 3. Prior to the adoption of a measure referred to in paragraph 1, the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 days, unless such consultation is not possible because of the urgency of the measure to be taken, as justified by health or safety requirements or other grounds relating to the public interests covered by the relevant Community harmonisation legislation. If action has been taken without the operator's being heard, the operator shall be given the opportunity to be heard as soon as possible and the action taken shall be reviewed promptly thereafter. 4. Any measure referred to in paragraph 1 shall be promptly withdrawn or amended upon the economic operator's demonstrating that he has taken effective action. Article 22 Exchange of information — Community Rapid Information System 1. Where a Member State takes or intends to take a measure in accordance with Article 20 and considers that the reasons which prompted the measure or the effects of the measure go beyond its territory, it shall immediately notify the Commission of that measure, in accordance with paragraph 4 of this Article. It shall also inform the Commission without delay of the modification or withdrawal of any such measure. 2. If a product presenting a serious risk has been made available on the market, Member States shall notify the Commission of any voluntary measures taken and communicated by an economic operator. 3. The information provided in accordance with paragraphs 1 and 2 shall include all available details, in particular the data necessary for the identification of the product, the origin and the supply chain of the product, the related risk, the nature and the duration of the national measure taken and any voluntary measures taken by economic operators. 4. For the purposes of paragraphs 1, 2 and 3, the market surveillance and information exchange system provided for in Article 12 of Directive 2001/95/EC shall be used. Paragraphs 2, 3 and 4 of Article 12 of that Directive shall apply mutatis mutandis. Article 23 General information support system 1. The Commission shall develop and maintain a general archiving and exchange of information system, using electronic means, on issues relating to market surveillance activities, programmes and related information on non-compliance with Community harmonisation legislation. The system shall appropriately reflect notifications and information provided under Article 22. 2. For the purposes of paragraph 1, Member States shall provide the Commission with information at their disposal and not already provided under Article 22 on products presenting a risk regarding, in particular, identification of risks, results of testing carried out, provisional restrictive measures taken, contacts with the economic operators concerned and justification for action or inaction. 3. Without prejudice to Article 19(5) or to national legislation in the area of confidentiality, the safeguarding of confidentiality with regard to the information content shall be ensured. The protection of confidentiality shall not prevent the dissemination to market surveillance authorities of information relevant to ensuring the effectiveness of market surveillance activities. Article 24 Principles of cooperation between the Member States and the Commission 1. Member States shall ensure efficient cooperation and exchange of information between their market surveillance authorities and those of the other Member States and between their own authorities and the Commission and the relevant Community agencies regarding their market surveillance programmes and all issues relating to products presenting risks. 2. For the purposes of paragraph 1, the market surveillance authorities of one Member State shall give the market surveillance authorities of other Member States assistance on an adequate scale by supplying information or documentation, by carrying out appropriate investigations or any other appropriate measure and by participating in investigations initiated in other Member States. 3. The Commission shall collect and organise such data on national market surveillance measures as will enable it to fulfil its obligations. 4. Any information provided by an economic operator under Article 21(3) or otherwise shall be included when the reporting Member State notifies other Member States and the Commission of its findings and actions. Any subsequent information shall be clearly identified as relating to the information already provided. Article 25 Sharing of resources 1. Market surveillance initiatives designed to share resources and expertise between the competent authorities of the Member States may be set up by the Commission or the Member States concerned. Such initiatives shall be coordinated by the Commission. 2. For the purposes of paragraph 1, the Commission shall, in cooperation with the Member States: (a) develop and organise training programmes and exchanges of national officials; (b) develop, organise and set up programmes for the exchange of experience, information and best practice, programmes and actions for common projects, information campaigns, joint visit programmes and the consequent sharing of resources. 3. Member States shall ensure that their competent authorities participate fully in the activities referred to in paragraph 2, where appropriate. Article 26 Cooperation with the competent authorities of third countries 1. Market surveillance authorities may cooperate with the competent authorities of third countries with a view to exchanging information and technical support, promoting and facilitating access to European systems and promoting activities relating to conformity assessment, market surveillance and accreditation. The Commission shall, in cooperation with Member States, develop appropriate programmes for that purpose. 2. Cooperation with the competent authorities of third countries shall take the form of, inter alia, the activities referred to in Article 25(2). Member States shall ensure that their competent authorities participate fully in those activities. SECTION 3 Controls of products entering the Community market Article 27 Controls of products entering the Community market 1. The authorities of the Member States in charge of the control of products entering the Community market shall have the powers and resources necessary for the proper performance of their tasks. They shall carry out appropriate checks on the characteristics of products on an adequate scale, in accordance with the principles set out in Article 19(1), before those products are released for free circulation. 2. Where in a Member State more than one authority is responsible for market surveillance or external border controls, those authorities shall cooperate with each other, by sharing information relevant to their functions and otherwise as appropriate. 3. The authorities in charge of external border controls shall suspend release of a product for free circulation on the Community market when any of the following findings are made in the course of the checks referred to in paragraph 1: (a) the product displays characteristics which give cause to believe that the product, when properly installed, maintained and used, presents a serious risk to health, safety, the environment or any other public interest referred to in Article 1; (b) the product is not accompanied by the written or electronic documentation required by the relevant Community harmonisation legislation or is not marked in accordance with that legislation; (c) the CE marking has been affixed to the product in a false or misleading manner. The authorities in charge of external border controls shall immediately notify the market surveillance authorities of any such suspension. 4. In the case of perishable products, the authorities in charge of external border controls shall, as far as possible, seek to ensure that any requirements they may impose with regard to the storage of products or the parking of vehicles used for transport are not incompatible with the preservation of those products. 5. For the purposes of this Section, Article 24 shall apply in respect of authorities in charge of external border controls, without prejudice to the application of Community law providing for more specific systems of cooperation between those authorities. Article 28 Release of products 1. A product the release of which has been suspended by the authorities in charge of external border controls pursuant to Article 27 shall be released if, within three working days of the suspension of release, those authorities have not been notified of any action taken by the market surveillance authorities, and provided that all the other requirements and formalities pertaining to such release have been fulfilled. 2. Where the market surveillance authorities find that the product in question does not present a serious risk to health and safety or cannot be regarded as being in breach of Community harmonisation legislation, that product shall be released, provided that all the other requirements and formalities pertaining to such release have been fulfilled. Article 29 National measures 1. Where the market surveillance authorities find that a product presents a serious risk, they shall take measures to prohibit that product from being placed on the market and shall require the authorities in charge of external border controls to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document or, where data processing is carried out electronically, in the data-processing system itself: ‘Dangerous product — release for free circulation not authorised — Regulation (EC) No 765/2008’. 2. Where the market surveillance authorities find that a product does not comply with Community harmonisation legislation, they shall take appropriate action, which may, if necessary, include prohibiting the product's being placed on the market. Where placing on the market is prohibited pursuant to the first subparagraph, the market surveillance authorities shall require the authorities in charge of external border controls not to release the product for free circulation and to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document or, where data processing is carried out electronically, in the data-processing system itself: ‘Product not in conformity — release for free circulation not authorised — Regulation (EC) No 765/2008’. 3. Where that product is subsequently declared for a customs procedure other than release for free circulation and provided that the market surveillance authorities do not object, the endorsements set out in paragraphs 1 and 2 shall also be included, under the same conditions, on the documents used in connection with that procedure. 4. Member States' authorities may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary and proportionate. 5. Market surveillance authorities shall provide authorities in charge of external border controls with information on product categories in which a serious risk or non-compliance within the meaning of paragraphs 1 and 2 has been identified. CHAPTER IV CE MARKING Article 30 General principles of the CE marking 1. The CE marking shall be affixed only by the manufacturer or his authorised representative. 2. The CE marking as presented in Annex II shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product. 3. By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing. 4. The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonisation legislation providing for its affixing. 5. The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired. 6. Without prejudice to Article 41, Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use. CHAPTER V COMMUNITY FINANCING Article 31 Body pursuing an aim of general European interest The body recognised under Article 14 shall be considered a body pursuing an aim of general European interest within the meaning of Article 162 of Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Regulation (EC, Euratom) No 1605/2002 (12). Article 32 Activities eligible for Community financing 1. The Community may finance the following activities in connection with the application of this Regulation: (a) the production and revision of sectoral accreditation schemes referred to in Article 13(3); (b) the activities of the secretariat of the body recognised under Article 14, such as the coordination of accreditation activities, the processing of technical work linked to the operation of the peer evaluation system, the provision of interested parties with information and the participation of the body in the activities of international organisations in the field of accreditation; (c) the drawing up and updating of contributions to guidelines in the fields of accreditation, notification to the Commission of conformity assessment bodies, conformity assessment and market surveillance; (d) inter-comparison activities linked to the operation of safeguard clauses; (e) the making available to the Commission of technical expertise for the purpose of assisting the Commission in its implementation of market surveillance administrative cooperation, including the financing of administrative cooperation groups, market surveillance decisions and safeguard clause cases; (f) the performance of preliminary or ancillary work in connection with the implementation of the conformity assessment, metrology, accreditation and market surveillance activities linked to the implementation of Community legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work, as well as European market surveillance campaigns and similar activities; (g) activities carried out under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of European conformity assessment, market surveillance and accreditation policies and systems among interested parties in the Community and at international level. 2. The activities referred to in paragraph 1(a) shall be eligible for Community financing only if the Committee set up by Article 5 of Directive 98/34/EC has been consulted on the requests to be submitted to the body recognised under Article 14 of this Regulation. Article 33 Bodies eligible for Community financing Community financing may be granted to the body recognised under Article 14 for the implementation of the activities set out in Article 32. However, Community financing may also be granted to other bodies for the carrying out of the activities set out in Article 32, except those set out in paragraph 1(a) and (b) of that Article. Article 34 Financing The appropriations allocated to the activities referred to in this Regulation shall be determined each year by the budgetary authority within the limits of the financial framework in force. Article 35 Financing arrangements 1. Community financing shall be provided: (a) without a call for proposals, to the body recognised under Article 14 to carry out those activities referred to in Article 32(1)(a) to (g) for which grants can be awarded in accordance with the Financial Regulation; (b) in the form of grants after a call for proposals, or by public procurement procedures, to other bodies to carry out the activities referred to in Article 32(1)(c) to (g). 2. The activities of the secretariat of the body recognised under Article 14 referred to in Article 32(1)(b) may be financed on the basis of operating grants. In the event of renewal, the operating grants shall not be decreased automatically. 3. Grant agreements may authorise flat-rate cover of the beneficiary's overheads up to a maximum of 10 % of total eligible direct costs for actions, except where the beneficiary's indirect costs are covered through an operating grant financed from the Community budget. 4. The common cooperation objectives and the administrative and financial conditions relating to the grants awarded to the body recognised under Article 14 may be defined in a framework partnership agreement signed by the Commission and that body, in accordance with the Financial Regulation and Regulation (EC, Euratom) No 2342/2002. The European Parliament and the Council shall be informed of the conclusion of any such agreement. Article 36 Management and monitoring 1. The appropriations determined by the budgetary authority for the financing of conformity assessment, accreditation and market surveillance activities may also cover administrative expenses relating to preparation, monitoring, inspection, auditing and evaluation which are directly necessary for the achievement of the objectives of this Regulation, and in particular studies, meetings, information and publication activities, expenses relating to informatics networks for the exchange of information and any other expenditure on administrative and technical assistance which the Commission may use for conformity assessment and accreditation activities. 2. The Commission shall evaluate the relevance of the conformity assessment, accreditation and market surveillance activities that receive Community financing in the light of the requirements of Community policies and legislation, and inform the European Parliament and the Council of the outcome of that evaluation by 1 January 2013 and every five years thereafter. Article 37 Protection of the Community's financial interests 1. The Commission shall ensure that, when the activities financed under this Regulation are implemented, the Community's financial interests are protected by the application of preventive measures against fraud, corruption and other illegal activities, by effective checks and by the recovery of amounts unduly paid and, if irregularities are detected, by effective, proportionate and dissuasive penalties, in accordance with Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (13), Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (14) and Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) (15). 2. For the purposes of the Community activities financed under this Regulation, the notion of irregularity referred to in Article 1(2) of Regulation (EC, Euratom) No 2988/95 shall mean any infringement of a provision of Community law or any breach of a contractual obligation resulting from an act or omission by an economic operator which has, or would have, the effect of prejudicing the general budget of the European Union or budgets managed by it by an unjustified item of expenditure. 3. Any agreements and contracts resulting from this Regulation shall provide for monitoring and financial control by the Commission or any representative which it authorises and for audits by the Court of Auditors, which may be conducted on the spot if necessary. CHAPTER VI FINAL PROVISIONS Article 38 Technical guidelines In order to facilitate the implementation of this Regulation, the Commission shall draw up non-binding guidelines in consultation with stakeholders. Article 39 Transitional provision Accreditation certificates issued before 1 January 2010 may remain valid until the date of their expiry, but no later than 31 December 2014. This Regulation shall, however, apply in the case of their extension or renewal. Article 40 Review and reporting By 2 September 2013, the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, of Directive 2001/95/EC and of any other relevant Community instrument addressing market surveillance. That report shall, in particular, analyse the consistency of Community rules in the field of market surveillance. If appropriate, it shall be accompanied by proposals to amend and/or consolidate the instruments concerned, in the interests of better regulation and simplification. It shall include an evaluation of the extension of the scope of Chapter III of this Regulation to all products. By 1 January 2013, and every five years thereafter, the Commission, in cooperation with the Member States, shall produce and submit to the European Parliament and to the Council a report on the implementation of this Regulation. Article 41 Penalties The Member States shall lay down rules on penalties for economic operators, which may include criminal sanctions for serious infringements, applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive and may be increased if the relevant economic operator has previously committed a similar infringement of the provisions of this Regulation. The Member States shall notify the Commission of those provisions by 1 January 2010 and shall notify it without delay of any subsequent amendment affecting them. Article 42 Amendment to Directive 2001/95/EC Article 8(3) of Directive 2001/95/EC shall be replaced by the following: ‘3. In the case of products posing a serious risk, the competent authorities shall with due dispatch take the appropriate measures referred to in paragraph 1(b) to (f). The existence of a serious risk shall be determined by the Member States, assessing each individual case on its merits and taking into account the guidelines referred to in point 8 of Annex II.’. Article 43 Repeal Regulation (EEC) No 339/93 is hereby repealed with effect from 1 January 2010. References to the repealed Regulation shall be construed as references to this Regulation. Article 44 Entry into force This Regulation shall enter into force on the 20th day after its publication in the Official Journal of the European Union. It shall apply from 1 January 2010. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 9 July 2008. For the European Parliament The President H.-G. PÖTTERING For the Council The President J.-P. JOUYET (1) OJ C 120, 16.5.2008, p. 1. (2) Opinion of the European Parliament of 21 February 2008 (not yet published in the Official Journal) and Council Decision of 23 June 2008. (3) See page 82 of this Official Journal. (4) OJ L 11, 15.1.2002, p. 4. (5) OJ L 145, 31.5.2001, p. 43. (6) OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1). (7) OJ L 8, 12.1.2001, p. 1. (8) OJ L 40, 17.2.1993, p. 1. Regulation as last amended by Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1). (9) OJ L 248, 16.9.2002, p. 1. Regulation as last amended by Regulation (EC) No 1525/2007 (OJ L 343, 27.12.2007, p. 9). (10) OJ L 204, 21.7.1998, p. 37. Directive as last amended by Council Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81). (11) OJ L 302, 19.10.1992, p. 1. Regulation as last amended by Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1). (12) OJ L 357, 31.12.2002, p. 1. Regulation as last amended by Regulation (EC, Euratom) No 478/2007 (OJ L 111, 28.4.2007, p. 13). (13) OJ L 312, 23.12.1995, p. 1. (14) OJ L 292, 15.11.1996, p. 2. (15) OJ L 136, 31.5.1999, p. 1. ANNEX I Requirements applicable to the body to be recognised under Article 14 1. The body recognised under Article 14 of the Regulation (the body), shall be established within the Community. 2. Under the body's constitution, national accreditation bodies from within the Community shall be entitled to be members of it, provided that they comply with the rules and objectives of the body and with the other conditions set out herein and as agreed with the Commission in the framework agreement. 3. The body shall consult all relevant stakeholders. 4. The body shall provide its members with peer evaluation services satisfying the requirements of Articles 10 and 11. 5. The body shall cooperate with the Commission in accordance with this Regulation. ANNEX II CE marking 1. The CE marking shall consist of the initials ‘CE’ taking the following form: 2. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing in paragraph 1 shall be respected. 3. Where specific legislation does not impose specific dimensions, the CE marking shall be at least 5 mm high.

Accreditation and market surveillance Accreditation and market surveillance SUMMARY OF: Regulation (EC) No 765/2008 — setting out the requirements for accreditation and market surveillance relating to the marketing of products WHAT IS THE AIM OF THE REGULATION? It lays down common rules for accrediting bodies that ensure non-food products in the European Union (EU) conform to certain requirements. It establishes a surveillance system to guarantee a high level of safety of those products and in general their compliance with applicable requirements. It also sets rules in regard to controls on imports from outside the EU; and establishes the general principles for CE marking*. KEY POINTS National accreditation bodies EU countries must: appoint a single not-for-profit national accreditation organisation; ensure the organisation has sufficient finance and staff to carry out its duties; monitor the organisation to ensure it fulfils the requirements given; communicate the relevant details to the European Commission which draws up a publicly available list of the various national organisations. National accreditation bodies must: determine whether individual conformity assessment organisations* are competent to do their work and monitor their performance; restrict, suspend or withdraw accreditation certificates for assessment organisations that become unable to carry out their duties; be objective and impartial with efficient management and appropriate internal controls in place; agree to peer evaluation; inform other national accreditation bodies of their conformity assessment activities; make regularly publicly available information on their work. The European co-operation for Accreditation (EA) manages the peer evaluations to ensure the quality of the services the national accreditation bodies provide. EU market surveillance and import controls EU countries must: organise and carry out market surveillance to ensure the safety of products; withdraw, restrict or ban products that could damage the health or safety of users and immediately inform the Commission of the action they have taken; establish procedures for handling and dealing with complaints; ensure national market surveillance authorities are appointed and provided with sufficient resources to carry out their tasks; ensure national market surveillance authorities cooperate and exchange information with each other; establish rules on penalties, which may include criminal sanctions, for serious breaches of the law. Market surveillance authorities must: carry out appropriate checks on a sufficient scale, taking account of risk assessments, complaints and other information; alert users in their own country of any dangers they discover; inform the EU’s rapid information system (RAPEX) of any serious risks; exchange information on product compliance via a common EU database; cooperate with authorities in other EU countries. National customs authorities may prevent an imported product from being sold in the EU if they believe it poses a serious risk to health, safety, the environment or any other public interest. CE marking may only be attached to a product by a manufacturer or someone mandated to operate on their behalf, provided it satisfies all the conformity standards. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2010. BACKGROUND It is essential that non-food products that can move freely between EU countries do not pose a danger to the public, the environment or general security. Accreditation is part of an overall system that includes conformity assessment and market surveillance. Provisions in the regulation for the latter complement those set out in other pieces of EU legislation. For more information, see: ‘Market surveillance for products’ on the European Commission's website. * KEY TERMS CE marking: a marking manufacturers use to indicate the item meets EU legal conformity standards. Conformity assessment body: a body that performs activities which include calibration, testing, certification and inspection. MAIN DOCUMENT Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, pp. 30-47) RELATED DOCUMENTS Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, pp. 4-17) Successive amendments to Directive 2001/95/EC have been incorporated into the original document. This consolidated version is of documentary value only. Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, pp. 82-128) Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (OJ L 218, 13.8.2008, pp. 21-29) last update 14.02.2017

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28.11.2018 EN Official Journal of the European Union L 303/39 REGULATION (EU) 2018/1806 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 November 2018 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (codification) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 77(2)(a) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Council Regulation (EC) No 539/2001 (2) has been substantially amended several times (3). In the interests of clarity and rationality, that Regulation should be codified. (2) This Regulation provides for full harmonisation as regards the third countries whose nationals are subject to a requirement to be in possession of a visa for the crossing of Member States' external borders (also referred to herein as ‘the visa requirement’) and those whose nationals are exempt from that requirement. (3) The determination of the third countries whose nationals are subject to, or exempt from, the visa requirement should be made on the basis of a considered, case-by-case assessment of a variety of criteria. That assessment should be made periodically and could lead to legislative proposals to amend Annex I to this Regulation, which lists the third countries whose nationals are required to be in possession of a visa when crossing the external borders of the Member States, and Annex II to this Regulation, which lists the third countries whose nationals are exempt from the requirement to be in possession of a visa when crossing the external borders of the Member States for stays of no more than 90 days in any 180-day period, notwithstanding the possibility of having country-specific amendments to those Annexes in particular circumstances, for instance as a result of a visa liberalisation process or as the ultimate consequence of a temporary suspension of the exemption from the visa requirement (also referred to herein as ‘the visa exemption’). (4) The composition of the lists of third countries in Annexes I and II should be, and should remain, consistent with the criteria set out in this Regulation. References to third countries in respect of which the situation has changed as regards those criteria should be transferred from one Annex to the other. (5) Developments in international law entailing changes in the status or designation of certain States or entities should be reflected in Annexes I and II. (6) As the Agreement on the European Economic Area (4) exempts nationals of Iceland, Liechtenstein and Norway from the visa requirement, those countries should not be included in the list in Annex II. (7) Since the Agreement between the European Community and its Member States, of the one part, and the Swiss Confederation, of the other part, on the free movement of persons (5) provides for free movement without visas for nationals of Switzerland and of the Member States, Switzerland should not be included in the list in Annex II. (8) As regards recognised refugees and stateless persons, without prejudice to obligations under international agreements signed by the Member States and in particular the European Agreement on the Abolition of Visas for Refugees of the Council of Europe, signed at Strasbourg on 20 April 1959, the decision as to the visa requirement or exemption should be based on the third country in which those persons reside and which issued their travel documents. However, given the differences in the national law applicable to recognised refugees and to stateless persons, Member States should be able to decide whether those categories of persons should be exempted, where the third country in which those persons reside and which issued their travel documents is a third country whose nationals are exempt from the visa requirement. (9) In accordance with Regulation (EC) No 1931/2006 of the European Parliament and of the Council (6) an exemption from the visa requirement should be laid down for holders of a local border traffic permit. (10) It should be possible for Member States to provide for exemptions from the visa requirement for holders of certain passports other than ordinary passports. (11) In specific cases where special visa rules are warranted, it should be possible for Member States to exempt certain categories of persons from the visa requirement or impose it on them in accordance with public international law or custom. (12) It should be possible for Member States to exempt from the visa requirement recognised refugees, all stateless persons, both those covered by the United Nations Convention relating to the Status of Stateless Persons of 28 September 1954 and those outside of the scope of that Convention, and school pupils travelling on school excursions, where the persons of these categories reside in a third country that is included in the list in Annex II to this Regulation. (13) The arrangements governing exemptions from the visa requirement should fully reflect actual practices. Certain Member States grant exemptions from the visa requirement for nationals of third countries included in the list of third countries whose nationals are required to be in possession of a visa when crossing the external borders of the Member States and who are members of the armed forces travelling on North Atlantic Treaty Organization (NATO) or Partnership for Peace business. For reasons of legal certainty, those exemptions, which are based on international obligations external to Union law, should be referred to in this Regulation. (14) Full visa reciprocity is an objective which the Union should pursue in a proactive manner in its relations with third countries, thus contributing to improving the credibility and consistency of the Union's external policy. (15) Provision should be made for a Union mechanism enabling the principle of reciprocity to be implemented if one of the third countries included in the list in Annex II decides to make the nationals of one or more Member States subject to a visa requirement. That mechanism should provide for a Union response as an act of solidarity, if such a third country applies a visa requirement for nationals of at least one Member State. (16) Upon receipt of a notification from a Member State that a third country included in the list in Annex II applies a visa requirement for nationals of that Member State, all Member States should react in common, thus providing a Union response to a situation which affects the Union as a whole and subjects its citizens to different treatment. (17) In order to ensure the appropriate involvement of the European Parliament and of the Council in the second phase of application of the reciprocity mechanism, given the particularly sensitive political nature of the suspension of the exemption from the visa requirement for all the nationals of a third country included in the list in Annex II and its horizontal implications for the Member States, the Schengen associated countries and the Union itself, in particular for their external relations and for the overall functioning of the Schengen area, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of certain elements of the reciprocity mechanism. Conferring such power on the Commission takes into account the need for political discussion on the Union policy on visas in the Schengen area. It reflects also the need to ensure sufficient transparency and legal certainty in the application of the reciprocity mechanism to all the nationals of the third country concerned, in particular through the corresponding temporary amendment of Annex II to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (7). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (18) This Regulation should provide for a mechanism for the temporary suspension of the exemption from the visa requirement for a third country included in the list in Annex II (‘the suspension mechanism’) in an emergency situation, where an urgent response is needed in order to solve the difficulties faced by at least one Member State, and taking the overall impact of the emergency situation on the Union as a whole into account. (19) In order to ensure the efficient application of the suspension mechanism and of certain provisions of the reciprocity mechanism, and in particular in order to allow for all relevant factors and the possible implications of the application of those mechanisms to be adequately taken into account, implementing powers should be conferred on the Commission with regard to the determination of the categories of nationals of the third country concerned who should be subject to a temporary suspension of the exemption from the visa requirement within the framework of the reciprocity mechanism, and of the corresponding duration of that suspension, as well as with regard to the suspension mechanism. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (8). The examination procedure should be used for the adoption of such implementing acts. (20) It is necessary to avoid and counter any abuse resulting from an exemption from the visa requirement for short-stay visits for nationals of a third country where they pose a threat to the public policy (ordre public) and the internal security of the Member State concerned. (21) The suspension mechanism should make it possible for Member States to notify circumstances leading to a possible suspension and for the Commission to trigger the suspension mechanism on its own initiative. (22) In particular, the use of the suspension mechanism should be facilitated by short reference periods and deadlines, allowing for a fast procedure, and the possible grounds of suspension should include a decrease in cooperation on readmission as well as a substantial increase in risks to the public policy or internal security of Member States. That decrease in cooperation should cover a substantial increase in the refusal rate of readmission applications, including for third-country nationals having transited through the third country concerned, where a readmission agreement concluded between the Union or a Member State and that third country provides for such a readmission obligation. The Commission should also be able to trigger the suspension mechanism in the event that the third country fails to cooperate on readmission, in particular where a readmission agreement has been concluded between the third country concerned and the Union. (23) For the purposes of the suspension mechanism, a substantial increase indicates an increase exceeding a threshold of 50 %. It could also indicate a lower increase if the Commission deemed it applicable in the particular case notified by the Member State concerned. (24) For the purposes of the suspension mechanism, a low recognition rate indicates a recognition rate of asylum applications of around 3 or 4 %. It could also indicate a higher recognition rate if the Commission deemed it applicable in the particular case notified by the Member State concerned. (25) It is necessary to avoid and counter any abuse of the visa exemption where it leads to an increase in migratory pressure, resulting from, for example, an increase in unfounded asylum applications, and also when it leads to unfounded applications for residence permits. (26) With a view to ensuring that the specific requirements which were used to assess the appropriateness of a visa exemption, granted as a result of a successful conclusion of a visa liberalisation dialogue, continue to be fulfilled over time, the Commission should monitor the situation in the third countries concerned. The Commission should pay particular attention to the situation of human rights in the third countries concerned. (27) The Commission should report regularly to the European Parliament and to the Council, at least once a year, for a period of seven years after the entry into force of visa liberalisation for a particular third country, and thereafter whenever the Commission considers it necessary, or upon request by the European Parliament or by the Council. (28) The Commission should, before taking any decision to temporarily suspend the visa exemption for nationals of a third country, take into account the situation of human rights in that third country and the possible consequences of a suspension of the visa exemption for that situation. (29) The suspension of the exemption from the visa requirement by an implementing act should cover certain categories of nationals of the third country concerned, by reference to the relevant types of travel documents and, where appropriate, to additional criteria, such as persons travelling for the first time to the territory of the Member States. The implementing act should determine the categories of nationals to which the suspension should apply, taking into account the specific circumstances notified by one or several Member States or reported by the Commission and the principle of proportionality. (30) In order to ensure the appropriate involvement of the European Parliament and of the Council in the implementation of the suspension mechanism, given the politically sensitive nature of a suspension of an exemption from the visa requirement for all nationals of a third country included in the list in Annex II to this Regulation and its horizontal implications for the Member States and the Union itself, in particular for their external relations and for the overall functioning of the Schengen area, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the temporary suspension of the exemption from the visa requirement for the nationals of the third countries concerned. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (31) With a view to ensuring that the visa regime is administered openly and that the persons concerned are informed, Member States should communicate to the Commission and to the other Member States the measures which they take pursuant to this Regulation. For the same reasons, that information should also be published in the Official Journal of the European Union. (32) The conditions governing entry into the territory of the Member States or the issue of visas should not affect the rules governing the recognition of the validity of travel documents. (33) In accordance with the principle of proportionality as set out in Article 5 of the Treaty on European Union, the recourse to a Regulation listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement is both a necessary and an appropriate means of ensuring that the common policy on visas operates efficiently. (34) This Regulation should be without prejudice to the application of international agreements concluded by the European Community before the entry into force of Regulation (EC) No 539/2001 which give rise to the need to derogate from the common policy on visas, while taking into account the case-law of the Court of Justice of the European Union. (35) As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters' association with the implementation, application and development of the Schengen acquis (9), which fall within the area referred to in point B of Article 1 of Council Decision 1999/437/EC (10). (36) As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement signed between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (11), which fall within the area referred to in points B and C of Article 1 of Decision 1999/437/EC, read in conjunction with Article 3 of Council Decision 2008/146/EC (12). (37) As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (13), which fall within the area referred to in points B and C of Article 1 of Decision 1999/437/EC, read in conjunction with Article 3 of Council Decision 2011/350/EU (14). (38) This Regulation constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (15); the United Kingdom is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (39) This Regulation constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (16); Ireland is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application, HAVE ADOPTED THIS REGULATION: Article 1 This Regulation determines the third countries whose nationals are subject to, or exempt from, the visa requirement, on the basis of a case-by-case assessment of a variety of criteria relating, inter alia, to illegal immigration, public policy and security, economic benefit, in particular in terms of tourism and foreign trade, and the Union's external relations with the relevant third countries, including, in particular, considerations of human rights and fundamental freedoms, as well as the implications of regional coherence and reciprocity. Article 2 For the purposes of this Regulation, ‘visa’ means a visa as defined in point (a) of Article 2(2) of Regulation (EC) No 810/2009 of the European Parliament and of the Council (17). Article 3 1. Nationals of third countries listed in Annex I shall be required to be in possession of a visa when crossing the external borders of the Member States. 2. Without prejudice to the requirements stemming from the European Agreement on the Abolition of Visas for Refugees of the Council of Europe signed at Strasbourg on 20 April 1959, recognised refugees and stateless persons shall be required to be in possession of a visa when crossing the external borders of the Member States if the third country where they are resident and which has issued them with their travel document is a third country listed in Annex I to this Regulation. Article 4 1. Nationals of third countries listed in Annex II shall be exempt from the requirement set out in Article 3(1) for stays of no more than 90 days in any 180-day period. 2. The following persons shall also be exempt from the visa requirement: (a) the nationals of third countries listed in Annex I to this Regulation who are holders of a local border traffic permit issued by the Member States pursuant to Regulation (EC) No 1931/2006 when those holders exercise their right within the context of the local border traffic regime; (b) school pupils who are nationals of a third country listed in Annex I to this Regulation, who reside in a Member State applying Council Decision 94/795/JHA (18) and who are travelling in the context of a school excursion as members of a group of school pupils accompanied by a teacher from the school in question; (c) recognised refugees and stateless persons and other persons who do not hold the nationality of any country, who reside in a Member State and who are holders of a travel document issued by that Member State. Article 5 Nationals of new third countries formerly part of third countries listed in Annexes I and II shall be subject respectively to Articles 3 and 4 unless and until the Council decides otherwise under the procedure laid down in the relevant provision of the TFEU. Article 6 1. A Member State may provide for exceptions from the visa requirement provided for in Article 3 or from the exemption from the visa requirement provided for in Article 4 as regards: (a) holders of diplomatic passports, service/official passports or special passports; (b) civilian air and sea crew members in the performance of their duties; (c) civilian sea crew members, when they go ashore, who hold a seafarer's identity document issued in accordance with the International Labour Organisation Conventions No 108 of 13 May 1958 or No 185 of 19 June 2003 or the International Maritime Organization Convention on Facilitation of International Maritime Traffic of 9 April 1965; (d) crew and members of emergency or rescue missions in the event of a disaster or an accident; (e) civilian crew of ships navigating in international inland waters; (f) holders of travel documents issued by intergovernmental international organisations of which at least one Member State is a member, or by other entities recognised by the Member State concerned as subjects of international law, to officials of those organisations or entities. 2. A Member State may exempt from the visa requirement provided for in Article 3: (a) a school pupil having the nationality of a third country listed in Annex I, who resides in a third country listed in Annex II or in Switzerland and Liechtenstein and who is travelling in the context of a school excursion as a member of a group of school pupils accompanied by a teacher from the school in question; (b) recognised refugees and stateless persons if the third country where they reside and which issued their travel document is one of the third countries listed in Annex II; (c) members of the armed forces travelling on NATO or Partnership for Peace business and holders of identification and movement orders provided for by the Agreement between the Parties to the North Atlantic Treaty regarding the Status of their Forces of 19 June 1951; (d) without prejudice to the requirements stemming from the European Agreement on the Abolition of Visas for Refugees of the Council of Europe signed at Strasbourg on 20 April 1959, recognised refugees and stateless persons and other persons who do not hold the nationality of any country who reside in the United Kingdom or in Ireland and are holders of a travel document issued by the United Kingdom or Ireland, which is recognised by the Member State concerned. 3. A Member State may provide for exceptions from the exemption from the visa requirement provided for in Article 4 as regards persons carrying out a paid activity during their stay. Article 7 Where a third country listed in Annex II applies a visa requirement for nationals of at least one Member State, the following provisions shall apply: (a) within 30 days of the implementation by the third country of the visa requirement, the Member State concerned shall notify the European Parliament, the Council and the Commission thereof in writing. That notification shall: (i) specify the date of implementation of the visa requirement and the types of travel documents and visas concerned; (ii) include a detailed explanation of the preliminary measures that the Member State concerned has taken with a view to ensuring visa-free travel with the third country in question and all relevant information. Information relating to that notification shall be published without delay by the Commission in the Official Journal of the European Union, including information on the date of implementation of the visa requirement and the types of travel documents and visas concerned. If the third country decides to lift the visa requirement before the expiry of the deadline referred to in the first subparagraph of this point, the notification shall not be made or shall be withdrawn and the information shall not be published; (b) the Commission shall, immediately following the date of the publication referred to in the third subparagraph of point (a) and in consultation with the Member State concerned, take steps with the authorities of the third country in question, in particular in the political, economic and commercial fields, in order to restore or introduce visa-free travel and shall inform the European Parliament and the Council of those steps without delay; (c) if within 90 days of the date of the publication referred to in the third subparagraph of point (a) and despite all the steps taken in accordance with point (b), the third country has not lifted the visa requirement, the Member State concerned may request the Commission to suspend the exemption from the visa requirement for certain categories of nationals of that third country. Where a Member State makes such a request, it shall inform the European Parliament and the Council thereof; (d) the Commission shall, when considering further steps in accordance with point (e), (f) or (h), take into account the outcome of the measures taken by the Member State concerned with a view to ensuring visa-free travel with the third country in question, the steps taken in accordance with point (b), and the consequences of the suspension of the exemption from the visa requirement for the external relations of the Union and its Member States with the third country in question; (e) if the third country concerned has not lifted the visa requirement, the Commission shall, at the latest within six months of the date of the publication referred to in the third subparagraph of point (a) and subsequently at intervals not exceeding six months within a total period which may not extend beyond the date on which the delegated act referred to in point (f) enters into force or is objected to: (i) adopt, at the request of the Member State concerned or on its own initiative, an implementing act temporarily suspending the exemption from the visa requirement for certain categories of nationals of the third country concerned for a period of up to six months. That implementing act shall fix a date, within 90 days of its entry into force, on which the suspension of the exemption from the visa requirement is to take effect, taking into account the available resources in the consulates of the Member States. When adopting subsequent implementing acts, the Commission may extend the period of that suspension by further periods of up to six months and may modify the categories of nationals of the third country in question for which the exemption from the visa requirement is suspended. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 11(2). Without prejudice to the application of Article 6, during the periods of suspension all the categories of nationals of the third country referred to in the implementing act shall be required to be in possession of a visa when crossing the external borders of the Member States; or (ii) submit to the committee referred to in Article 11(1) a report assessing the situation and stating the reasons why it decided not to suspend the exemption from the visa requirement and inform the European Parliament and the Council thereof. All relevant factors, such as those referred to in point (d), shall be taken into account in that report. The European Parliament and the Council may have a political discussion on the basis of that report; (f) if within 24 months of the date of the publication referred to in the third subparagraph of point (a), the third country concerned has not lifted the visa requirement, the Commission shall adopt a delegated act in accordance with Article 10 temporarily suspending the exemption from the visa requirement for a period of 12 months for the nationals of that third country. The delegated act shall fix a date, within 90 days of its entry into force, on which the suspension of the exemption from the visa requirement is to take effect, taking into account the available resources in the consulates of the Member States and shall amend Annex II accordingly. That amendment shall be made by inserting next to the name of the third country in question a footnote indicating that the exemption from the visa requirement is suspended with regard to that third country and specifying the period of that suspension. From the date when the suspension of the exemption from the visa requirement for the nationals of the third country concerned takes effect or when an objection to the delegated act is expressed pursuant to Article 10(7), any implementing act adopted pursuant to point (e) of this Article concerning that third country shall expire. Where the Commission submits a legislative proposal as referred to in point (h), the period of suspension of the exemption from the visa requirement referred to in the first subparagraph of this point shall be extended by six months. The footnote referred to in that subparagraph shall be amended accordingly. Without prejudice to the application of Article 6, during the periods of that suspension the nationals of the third country concerned by the delegated act shall be required to be in possession of a visa when crossing the external borders of the Member States; (g) any subsequent notification made by another Member State pursuant to point (a) concerning the same third country during the period of application of measures adopted pursuant to point (e) or (f) with regard to that third country shall be merged into the ongoing procedures without the deadlines or periods set out in those points being extended; (h) if within six months of the entry into force of the delegated act referred to in point (f) the third country in question has not lifted the visa requirement, the Commission may submit a legislative proposal to amend this Regulation in order to transfer the reference to the third country from Annex II to Annex I; (i) the procedures referred to in points (e), (f) and (h) shall not affect the right of the Commission to submit at any time a legislative proposal to amend this Regulation in order to transfer the reference to the third country concerned from Annex II to Annex I; (j) where the third country in question lifts the visa requirement, the Member State concerned shall immediately notify the European Parliament, the Council and the Commission thereof. The notification shall be published without delay by the Commission in the Official Journal of the European Union. Any implementing or delegated act adopted pursuant to point (e) or (f) concerning the third country in question shall expire seven days after the publication referred to in the first subparagraph of this point. Where the third country in question has introduced a visa requirement for nationals of two or more Member States, the implementing or delegated act concerning that third country shall expire seven days after the publication of the notification concerning the last Member State whose nationals were subject to the visa requirement by that third country. The footnote referred to in the first subparagraph of point (f) shall be deleted upon expiry of the delegated act concerned. The information concerning that expiry shall be published without delay by the Commission in the Official Journal of the European Union. Where the third country in question lifts the visa requirement without the Member State concerned notifying it in accordance with the first subparagraph of this point, the Commission shall on its own initiative proceed without delay with the publication referred to in that subparagraph, and the second subparagraph of this point shall apply. Article 8 1. By way of derogation from Article 4, the exemption from the visa requirement for nationals of a third country listed in Annex II shall be temporarily suspended, based on relevant and objective data, in accordance with this Article. 2. A Member State may notify the Commission if it is confronted, over a two-month period, compared with the same period in the preceding year or compared with the last two months prior to the implementation of the exemption from the visa requirement for nationals of a third country listed in Annex II, with one or more of the following circumstances: (a) a substantial increase in the number of nationals of that third country refused entry or found to be staying in the Member State's territory without a right to do so; (b) a substantial increase in the number of asylum applications from the nationals of that third country for which the recognition rate is low; (c) a decrease in cooperation on readmission with that third country, substantiated by adequate data, in particular a substantial increase in the refusal rate of readmission applications submitted by the Member State to that third country for its own nationals or, where a readmission agreement concluded between the Union or that Member State and that third country so provides, for third-country nationals having transited through that third country; (d) an increased risk or imminent threat to the public policy or internal security of Member States, in particular a substantial increase in serious criminal offences, linked to the nationals of that third country, substantiated by objective, concrete and relevant information and data provided by the competent authorities. The notification referred to in the first subparagraph of this paragraph shall state the reasons on which it is based and shall include relevant data and statistics as well as a detailed explanation of the preliminary measures that the Member State concerned has taken with a view to remedying the situation. In its notification, the Member State concerned may specify the categories of nationals of the third country concerned which are to be covered by an implementing act under point (a) of paragraph 6, specifying the detailed reasons for doing so. The Commission shall inform the European Parliament and the Council immediately of such notification. 3. Where the Commission, taking into account the relevant data, reports and statistics, has concrete and reliable information that the circumstances referred to in point (a), (b), (c) or (d) of paragraph 2 are occurring in one or more Member States, or that the third country is not cooperating on readmission, in particular where a readmission agreement has been concluded between that third country and the Union, the Commission shall inform the European Parliament and the Council promptly of its analysis, and the provisions of paragraph 6 shall apply. For the purposes of the first subparagraph, non-cooperation on readmission may consist in, for instance: — refusing or failing to process readmission applications in due time; — failing to issue travel documents in due time for the purposes of returning within the deadlines set out in the readmission agreement or refusing to accept European travel documents issued following the expiry of the deadlines set out in the readmission agreement; or — terminating or suspending the readmission agreement. 4. The Commission shall monitor the continuous compliance with the specific requirements, which are based on Article 1 and which were used to assess the appropriateness of granting visa liberalisation, by the third countries whose nationals have been exempted from the visa requirement when travelling to the territory of Member States as a result of the successful conclusion of a visa liberalisation dialogue conducted between the Union and that third country. In addition, the Commission shall report regularly to the European Parliament and to the Council, at least once a year, for a period of seven years after the date of entry into force of visa liberalisation for that third country, and thereafter whenever the Commission considers it to be necessary, or upon request by the European Parliament or by the Council. The report shall focus on the third countries which the Commission considers, based on concrete and reliable information, are no longer complying with certain requirements. Paragraph 6 shall apply where a report of the Commission shows that one or more of the specific requirements is no longer complied with as regards a particular third country. 5. The Commission shall examine any notification made pursuant to paragraph 2, taking the following into account: (a) whether any of the circumstances referred to in paragraph 2 exist; (b) the number of Member States affected by any of the circumstances referred to in paragraph 2; (c) the overall impact of the circumstances referred to in paragraph 2 on the migratory situation in the Union as it appears from the data provided by the Member States or available to the Commission; (d) the reports prepared by the European Border and Coast Guard, the European Asylum Support Office or the European Union Agency for Law Enforcement Cooperation (Europol) or any other institution, body, office or agency of the Union or international organisation competent in matters covered by this Regulation, if the circumstances so require in the specific case; (e) the information which the Member State concerned may have given in its notification in relation to possible measures under point (a) of paragraph 6; (f) the overall question of public policy and internal security, in consultation with the Member State concerned. The Commission shall inform the European Parliament and the Council of the results of its examination. 6. Where, on the basis of the analysis referred to in paragraph 3, the report referred to in paragraph 4, or the examination referred to in paragraph 5, and taking into account the consequences of a suspension of the exemption from the visa requirement for the external relations of the Union and its Member States with the third country concerned, while working in close cooperation with that third country to find alternative long-term solutions, the Commission decides that action is needed, or where a simple majority of Member States have notified the Commission of the existence of circumstances referred to in point (a), (b), (c) or (d) of paragraph 2, the following provisions shall apply: (a) the Commission shall adopt an implementing act temporarily suspending the exemption from the visa requirement for the nationals of the third country concerned for a period of nine months. The suspension shall apply to certain categories of nationals of the third country concerned, by reference to the relevant types of travel documents and, where appropriate, to additional criteria. When deciding to which categories the suspension is to apply, the Commission shall, based on the information available, include categories that are broad enough in order to efficiently contribute to remedying the circumstances referred to in paragraphs 2, 3 and 4 in each specific case, while respecting the principle of proportionality. The Commission shall adopt the implementing act within one month of: (i) receiving the notification referred to in paragraph 2; (ii) being made aware of the information referred to in paragraph 3; (iii) presenting the report referred to in paragraph 4; or (iv) receiving the notification from a simple majority of Member States of the existence of circumstances referred to in point (a), (b), (c) or (d) of paragraph 2. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 11(2). It shall fix the date on which the suspension of the exemption from the visa requirement is to take effect. During the period of suspension, the Commission shall establish an enhanced dialogue with the third country concerned with a view to remedying the circumstances in question. (b) Where the circumstances referred to in paragraphs 2, 3 and 4 of this Article persist, the Commission shall adopt, at the latest two months before the expiry of the nine-month period referred to in point (a) of this paragraph, a delegated act in accordance with Article 10, temporarily suspending the application of Annex II for a period of 18 months for all nationals of the third country concerned. The delegated act shall take effect from the date of expiry of the implementing act referred to in point (a) of this paragraph and shall amend Annex II accordingly. That amendment shall be made by inserting a footnote next to the name of the third country in question, indicating that the exemption from the visa requirement is suspended with regard to that third country and specifying the period of that suspension. Where the Commission has submitted a legislative proposal pursuant to paragraph 7, the period of suspension of the exemption from the visa requirement provided for in the delegated act shall be extended by six months. The footnote shall be amended accordingly. Without prejudice to the application of Article 6, during the period of suspension, the nationals of the third country concerned shall be required to be in possession of a visa when crossing the external borders of the Member States. A Member State which, in accordance with Article 6, provides for new exemptions from the visa requirement for a category of nationals of the third country covered by the act suspending the exemption from the visa requirement shall communicate those measures in accordance with Article 12. 7. Before the end of the period of validity of the delegated act adopted pursuant to point (b) of paragraph 6, the Commission shall submit a report to the European Parliament and to the Council. The report may be accompanied by a legislative proposal to amend this Regulation in order to transfer the reference to the third country concerned from Annex II to Annex I. 8. Where the Commission has submitted a legislative proposal pursuant to paragraph 7, it may extend the validity of the implementing act adopted pursuant to point (a) of paragraph 6 of this Article by a period not exceeding 12 months. The decision to extend the validity of the implementing act shall be adopted in accordance with the examination procedure referred to in Article 11(2). Article 9 1. By 10 January 2018, the Commission shall submit a report to the European Parliament and to the Council assessing the effectiveness of the reciprocity mechanism provided for in Article 7 and shall, if necessary, submit a legislative proposal to amend this Regulation. The European Parliament and the Council shall act on any such proposal in accordance with the ordinary legislative procedure. 2. By 29 March 2021, the Commission shall submit a report to the European Parliament and to the Council assessing the effectiveness of the suspension mechanism provided for in Article 8 and shall, if necessary, submit a legislative proposal to amend this Regulation. The European Parliament and the Council shall act on any such proposal in accordance with the ordinary legislative procedure. Article 10 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in point (f) of Article 7 shall be conferred on the Commission for a period of five years from 9 January 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The power to adopt delegated acts referred to in point (b) of Article 8(6) shall be conferred on the Commission for a period of five years from 28 March 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 4. The delegation of power referred to in point (f) of Article 7 and in point (b) of Article 8(6) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 5. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 6. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 7. A delegated act adopted pursuant to point (f) of Article 7 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of four months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. 8. A delegated act adopted pursuant to point (b) of Article 8(6) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. Article 11 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 12 1. Member States shall communicate to the other Member States and the Commission the measures they take pursuant to Article 6, within five working days of the adoption of those measures. 2. The Commission shall publish the measures communicated pursuant to paragraph 1 in the Official Journal of the European Union for information. Article 13 This Regulation shall not affect the competence of Member States with regard to the recognition of States and territorial units and passports, travel and identity documents issued by their authorities. Article 14 Regulation (EC) No 539/2001 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IV. Article 15 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 14 November 2018. For the European Parliament The President A. TAJANI For the Council The President K. EDTSTADLER (1) Position of the European Parliament of 2 October 2018 (not yet published in the Official Journal) and decision of the Council of 6 November 2018. (2) Council Regulation (EC) No 539/2001 of 15 March 2001 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (OJ L 81, 21.3.2001, p. 1). (3) See Annex III. (4) OJ L 1, 3.1.1994, p. 3. (5) OJ L 114, 30.4.2002, p. 6. (6) Regulation (EC) No 1931/2006 of the European Parliament and of the Council of 20 December 2006 laying down rules on local border traffic at the external land borders of the Member States and amending the provisions of the Schengen Convention (OJ L 405, 30.12.2006, p. 1). (7) OJ L 123, 12.5.2016, p. 1. (8) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (9) OJ L 176, 10.7.1999, p. 36. (10) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31). (11) OJ L 53, 27.2.2008, p. 52. (12) Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1). (13) OJ L 160, 18.6.2011, p. 21. (14) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19). (15) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43). (16) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20). (17) Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1). (18) Council Decision 94/795/JHA of 30 November 1994 on a joint action adopted by the Council on the basis of Article K.3.2.b of the Treaty on European Union concerning travel facilities for school pupils from third countries resident in a Member State (OJ L 327, 19.12.1994, p. 1). ANNEX I LIST OF THIRD COUNTRIES WHOSE NATIONALS ARE REQUIRED TO BE IN POSSESSION OF A VISA WHEN CROSSING THE EXTERNAL BORDERS OF THE MEMBER STATES 1. STATES Afghanistan Armenia Angola Azerbaijan Bangladesh Burkina Faso Bahrain Burundi Benin Bolivia Bhutan Botswana Belarus Belize Democratic Republic of the Congo Central African Republic Congo Côte d'Ivoire Cameroon China Cuba Cape Verde Djibouti Dominican Republic Algeria Ecuador Egypt Eritrea Eswatini Ethiopia Fiji Gabon Ghana The Gambia Guinea Equatorial Guinea Guinea-Bissau Guyana Haiti Indonesia India Iraq Iran Jamaica Jordan Kenya Kyrgyzstan Cambodia Comoros North Korea Kuwait Kazakhstan Laos Lebanon Sri Lanka Liberia Lesotho Libya Morocco Madagascar Mali Myanmar/Burma Mongolia Mauritania Maldives Malawi Mozambique Namibia Niger Nigeria Nepal Oman Papua New Guinea Philippines Pakistan Qatar Russia Rwanda Saudi Arabia Sudan Sierra Leone Senegal Somalia Suriname South Sudan São Tomé and Príncipe Syria Chad Togo Thailand Tajikistan Turkmenistan Tunisia Turkey Tanzania Uganda Uzbekistan Vietnam Yemen South Africa Zambia Zimbabwe 2. ENTITIES AND TERRITORIAL AUTHORITIES THAT ARE NOT RECOGNISED AS STATES BY AT LEAST ONE MEMBER STATE — Kosovo as defined by the United Nations Security Council Resolution 1244 of 10 June 1999 — The Palestinian Authority ANNEX II LIST OF THIRD COUNTRIES WHOSE NATIONALS ARE EXEMPT FROM THE REQUIREMENT TO BE IN POSSESSION OF A VISA WHEN CROSSING THE EXTERNAL BORDERS OF THE MEMBER STATES FOR STAYS OF NO MORE THAN 90 DAYS IN ANY 180-DAY PERIOD 1. STATES former Yugoslav Republic of Macedonia (1) Andorra United Arab Emirates (2) Antigua and Barbuda Albania (1) Argentina Australia Bosnia and Herzegovina (1) Barbados Brunei Brazil Bahamas Canada Chile Colombia Costa Rica Dominica (2) Micronesia (2) Grenada (2) Georgia (3) Guatemala Honduras Israel Japan Kiribati (2) Saint Kitts and Nevis South Korea Saint Lucia (2) Monaco Moldova (4) Montenegro (5) Marshall Islands (6) Mauritius Mexico Malaysia Nicaragua Nauru (6) New Zealand Panama Peru (6) Palau (6) Paraguay Serbia (excluding holders of Serbian passports issued by the Serbian Coordination Directorate (in Serbian: Koordinaciona uprava)) (5) Solomon Islands Seychelles Singapore San Marino El Salvador Timor-Leste (6) Tonga (6) Trinidad and Tobago Tuvalu (6) Ukraine (7) United States Uruguay Holy See Saint Vincent and the Grenadines (6) Venezuela Vanuatu (6) Samoa 2. SPECIAL ADMINISTRATIVE REGIONS OF THE PEOPLE'S REPUBLIC OF CHINA Hong Kong SAR (8) Macao SAR (9) 3. BRITISH CITIZENS WHO ARE NOT NATIONALS OF THE UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND FOR THE PURPOSES OF UNION LAW British nationals (Overseas) British overseas territories citizens (BOTC) British overseas citizens (BOC) British protected persons (BPP) British subjects (BS) 4. ENTITIES AND TERRITORIAL AUTHORITIES THAT ARE NOT RECOGNISED AS STATES BY AT LEAST ONE MEMBER STATE Taiwan (10) (1) The exemption from the visa requirement shall only apply to holders of biometric passports. (2) The exemption from the visa requirement shall apply from the date of entry into force of an agreement on visa exemption to be concluded with the European Union. (3) The exemption from the visa requirement shall be limited to the holders of biometric passports issued by Georgia in line with standards of the International Civil Aviation Organisation (ICAO). (4) The exemption from the visa requirement shall be limited to the holders of biometric passports issued by Moldova in line with standards of the International Civil Aviation Organisation (ICAO). (5) The exemption from the visa requirement shall only apply to holders of biometric passports. (6) The exemption from the visa requirement shall apply from the date of entry into force of an agreement on visa exemption to be concluded with the European Union. (7) The exemption from the visa requirement shall be limited to the holders of biometric passports issued by Ukraine in line with standards of the International Civil Aviation Organisation (ICAO). (8) The exemption from the visa requirement shall only apply to holders of a ‘Hong Kong Special Administrative Region’ passport. (9) The exemption from the visa requirement shall only apply to holders of a ‘Região Administrativa Especial de Macau’ passport. (10) The exemption from the visa requirement shall only apply to holders of passports issued by Taiwan which include an identity card number. ANNEX III REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS Council Regulation (EC) No 539/2001 (OJ L 81, 21.3.2001, p. 1) Council Regulation (EC) No 2414/2001 (OJ L 327, 12.12.2001, p. 1) Council Regulation (EC) No 453/2003 (OJ L 69, 13.3.2003, p. 10) Act of Accession of 2003, Annex II, point 18(B) Council Regulation (EC) No 851/2005 (OJ L 141, 4.6.2005, p. 3) Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1) Only the eleventh indent of Article 1(1) as regards Regulation (EC) No 539/2001, and point 11(B)(3) of the Annex Council Regulation (EC) No 1932/2006 (OJ L 405, 30.12.2006, p. 23) Council Regulation (EC) No 1244/2009 (OJ L 336, 18.12.2009, p. 1) Regulation (EU) No 1091/2010 of the European Parliament and of the Council (OJ L 329, 14.12.2010, p. 1) Regulation (EU) No 1211/2010 of the European Parliament and of the Council (OJ L 339, 22.12.2010, p. 6) Council Regulation (EU) No 517/2013 (OJ L 158, 10.6.2013, p. 1) Only the fourth indent of Article 1(1)(k) and point 13(B)(2) of the Annex Regulation (EU) No 610/2013 of the European Parliament and of the Council (OJ L 182, 29.6.2013, p. 1) Only Article 4 Regulation (EU) No 1289/2013 of the European Parliament and of the Council (OJ L 347, 20.12.2013, p. 74) Regulation (EU) No 259/2014 of the European Parliament and of the Council (OJ L 105, 8.4.2014, p. 9) Regulation (EU) No 509/2014 of the European Parliament and of the Council (OJ L 149, 20.5.2014, p. 67) Regulation (EU) 2017/371 of the European Parliament and of the Council (OJ L 61, 8.3.2017, p. 1) Regulation (EU) 2017/372 of the European Parliament and of the Council (OJ L 61, 8.3.2017, p. 7) Regulation (EU) 2017/850 of the European Parliament and of the Council (OJ L 133, 22.5.2017, p. 1) ANNEX IV CORRELATION TABLE Regulation (EC) No 539/2001 This Regulation Article -1 Article 1 Article 1(1), first subparagraph Article 3(1) Article 1(1), second subparagraph Article 3(2) Article 1(2), first subparagraph Article 4(1) Article 1(2), second subparagraph, introductory wording Article 4(2), introductory wording Article 1(2), second subparagraph, first indent Article 4(2)(a) Article 1(2), second subparagraph, second indent Article 4(2)(b) Article 1(2), second subparagraph, third indent Article 4(2)(c) Article 1(3) Article 5 Article 1(4) Article 7 Article 1a(1) and (2) Article 8(1) and (2) Article 1a(2a) Article 8(3) Article 1a(2b) Article 8(4) Article 1a(3) Article 8(5) Article 1a(4) Article 8(6) Article 1a(5) Article 8(7) Article 1a(6) Article 8(8) Article 1b Article 9(1) Article 1c Article 9(2) Article 2 Article 2 Article 4 Article 6 Article 4a Article 11 Article 4b(1) and (2) Article 10(1) and (2) Article 4b(2a) Article 10(3) Article 4b(3) Article 10(4) Article 4b(3a) Article 10(5) Article 4b(4) Article 10(6) Article 4b(5) Article 10(7) Article 4b(6) Article 10(8) Article 5 Article 12 Article 6 Article 13 Article 7 Article 14 Article 8 Article 15 Annex I Annex I Annex II Annex II — Annex III — Annex IV

Visa requirements for non-EU nationals Visa requirements for non-EU nationals SUMMARY OF: Regulation (EU) 2018/1806 — list of non-EU countries whose nationals must be in possession of visas when entering the EU and those whose nationals are exempt from that requirement WHAT IS THE AIM OF THIS REGULATION? It lists the countries covered by this legislation and those that are exempt. The regulation repeals and codifies the much-amended Regulation (EC) No 539/2001. KEY POINTS The regulation develops from the Schengen Agreement and Convention in which neither the United Kingdom (1) nor Ireland take part, and are therefore not bound by it or subject to its application. The regulation lists, in its annex: the non-EU countries and territories whose nationals must hold a visa; and those countries and territories whose nationals are exempt from the visa requirements when entering the EU for stays of up to 90 days in any 180-day period. The regulation also allows for: exceptions: the possibility for EU countries to grant exceptions to the visa requirement for certain categories of persons such as holders of diplomatic or service passports, civilian air and sea crews, school pupils in groups, holders of local traffic permits, and exemptions for recognised refugees and stateless persons who live in the EU and hold a travel document issued by their country of residence; reciprocity: a mechanism allowing reciprocity if any visa-exempt non-EU country decides to impose a visa requirement on any EU country; temporary suspension: a mechanism for the temporary suspension of visa exemptions in an emergency situation such as a substantial increase of migratory or security risk. Decisions to amend the lists are on a case-by-case basis considering criteria including: illegal immigration, public policy and security; economic benefit, in particular in terms of tourism and foreign trade; the EU’s external relations with the relevant non-EU country, in particular relating to human rights and fundamental freedoms, regional coherence and reciprocity. FROM WHEN DOES THIS REGULATION APPLY? It has applied since 18 December 2018. The Regulation (EU) 2018/1806 codifies and replaces Regulation (EC) No 539/2001 and its subsequent amendments. BACKGROUND See also: Visa policy (European Commission). MAIN DOCUMENT Regulation (EU) 2018/1806 of the European Parliament and of the Council of 14 November 2018 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (codification) (OJ L 303, 28.11.2018, pp. 39-58) RELATED DOCUMENTS Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, pp. 19-20) Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (OJ L 160, 18.6.2011, pp. 21-36) Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, pp. 1-58) Successive amendments to Regulation (EC) No 810/2009 have been incorporated into the original document. This consolidated version is of documentary value only. Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, pp. 1-2) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland’s request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, pp. 20-23) Council Regulation (EC) No 539/2001 of 15 March 2001 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (OJ L 81, 21.3.2001, pp.1-7) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, pp. 43-47) See consolidated version. Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, pp. 31-33) last update 07.03.2019(1) The United Kingdom withdraws from the European Union and becomes a third country (non-EU country) as of 1 February 2020.

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EUR-Lex - 22006A1021(01) - EN Important legal notice | 22006A1021(01) Agreement between the European Union and the Republic of Iceland and the Kingdom of Norway on the surrender procedure between the Member States of the European Union and Iceland and Norway - Declarations Official Journal L 292 , 21/10/2006 P. 0002 - 0019 Agreementbetween the European Union and the Republic of Iceland and the Kingdom of Norway on the surrender procedure between the Member States of the European Union and Iceland and NorwayTHE EUROPEAN UNION,on the one hand, andTHE REPUBLIC OF ICELANDandTHE KINGDOM OF NORWAY,on the other hand,hereinafter referred to as "the Contracting Parties",WISHING to improve judicial cooperation in criminal matters between the Member States of the European Union and Iceland and Norway, without prejudice to the rules protecting individual freedom,CONSIDERING that current relationships among the Contracting Parties require close cooperation in the fight against crime,EXPRESSING their mutual confidence in the structure and functioning of their legal systems and in the ability of all Contracting Parties to guarantee a fair trial,CONSIDERING that Iceland and Norway have expressed their wish to enter into an agreement enabling them to expedite arrangements for handing over suspects and convicts with the Member States of the European Union and to apply a surrender procedure with the Member States,CONSIDERING that the European Union also considers it desirable to have such an agreement in place,CONSIDERING that it is therefore appropriate to set up a system for such surrender procedure,CONSIDERING that all Member States and the Kingdom of Norway and the Republic of Iceland are parties to a number of conventions in the field of extradition, including the European Convention on extradition of 13 December 1957 and the European Convention on the suppression of terrorism of 27 January 1977. The Nordic States have uniform extradition laws with a common concept of extradition,CONSIDERING that the level of cooperation under the EU Convention of 10 March 1995 on simplified extradition procedure and of the EU Convention of 27 September 1996 relating to extradition should be maintained where it is not possible to increase it,CONSIDERING that decisions on the execution of the arrest warrant as defined by this Agreement must be subject to sufficient controls, which means that a judicial authority of the State where the requested person has been arrested should have to take the decision on his or her surrender,CONSIDERING that the role of central authorities in the execution of an arrest warrant as defined by this Agreement should be limited to practical and administrative assistance,CONSIDERING that this Agreement respects fundamental rights and in particular the European Convention on Human Rights and Fundamental Freedoms.This Agreement does not prevent a State from applying its constitutional rules relating to due process, freedom of association, freedom of the press, freedom of expression in other media and freedom fighters,CONSIDERING that no person should be surrendered to a State where there is a serious risk that he or she would be subjected to the death penalty, torture or other inhuman or degrading treatment or punishment,CONSIDERING that since all States have ratified the Council of Europe Convention of 28 January 1981 for the protection of individuals with regard to automatic processing of personal data, the personal data processed in the context of the implementation of this Agreement should be protected in accordance with the principles of the said Convention,HAVE AGREED AS FOLLOWS:CHAPTER 1GENERAL PRINCIPLESArticle 1Object and purpose1. The Contracting Parties undertake to improve, in accordance with the provisions of this Agreement, the surrender for the purpose of prosecution or execution of sentence between, on the one hand, the Member States and, on the other hand, the Kingdom of Norway and the Republic of Iceland, by taking account of, as minimum standards, the terms of the Convention of 27 September 1996 relating to extradition between the Member States of the European Union.2. The Contracting Parties undertake, in accordance with the provisions of this Agreement, to ensure that the extradition system between, on the one hand, the Member States and, on the other hand, the Kingdom of Norway and the Republic of Iceland shall be based on a mechanism of surrender pursuant to an arrest warrant in accordance with the terms of this Agreement.3. This Agreement shall not have the effect of modifying the obligation to respect fundamental rights and fundamental legal principles as enshrined in the European Convention on Human Rights, or, in case of execution by the judicial authority of a Member State, of the principles referred to in Article 6 of the Treaty on European Union.4. Nothing in this Agreement should be interpreted as prohibiting refusal to surrender a person in respect of whom an arrest warrant as defined by this Agreement has been issued when there are reasons to believe, on the basis of objective elements, that the said arrest warrant has been issued for the purpose of prosecuting or punishing a person on the grounds of his or her sex, race, religion, ethnic origin, nationality, language, political opinions or sexual orientation, or that that person's position may be prejudiced for any of these reasons.Article 2Definitions1. "Contracting Parties" shall mean the European Union and the Kingdom of Norway and the Republic of Iceland.2. "Member State" shall mean a Member State of the European Union.3. "State" shall mean a Member State, the Kingdom of Norway or the Republic of Iceland.4. "Third State" shall mean any State other than a State as defined in paragraph 3.5. "Arrest warrant" shall mean a judicial decision issued by a State with a view to the arrest and surrender by another State of a requested person, for the purposes of conducting a criminal prosecution or executing a custodial sentence or detention order.Article 3Scope1. An arrest warrant may be issued for acts punishable by the law of the issuing State by a custodial sentence or a detention order for a maximum period of at least 12 months or, where a sentence has been passed or a detention order has been made, for sentences of at least four months.2. Without prejudice to paragraphs 3 and 4, surrender shall be subject to the condition that the acts for which the arrest warrant has been issued constitute an offence under the law of the executing State, whatever the constituent elements or however it is described.3. Subject to Articles 4, 5(1)(b) to (g), 6, 7 and 8, in no case shall a State refuse to execute an arrest warrant issued in relation to the behaviour of any person who contributes to the commission by a group of persons acting with a common purpose of one or more offences in the field of terrorism referred to in Articles 1 and 2 of the European Convention on the Suppression of Terrorism and Articles 1, 2, 3 and 4 of the Framework Decision of 13 June 2002 on combating terrorism, illicit trafficking in narcotic drugs and psychotropic substances, or murder, grievous bodily injury, kidnapping, illegal restraint, hostage-taking and rape, punishable by deprivation of liberty or a detention order of a maximum of at least 12 months, even where that person does not take part in the actual execution of the offence or offences concerned; such contribution shall be intentional and made with the further knowledge that his or her participation will contribute to the achievement of the organisation's criminal activities.4. Norway and Iceland, on the one hand, and the EU, on behalf of any of its Member States, on the other hand may make a declaration to the effect that, on the basis of reciprocity, the condition of double criminality referred to in paragraph 2 shall not be applied under the conditions set out hereafter. The following offences, if they are punishable in the issuing State by a custodial sentence or a detention order for a maximum period of at least three years and as they are defined by the law of the issuing State, shall, under the terms of this Agreement and without verification of the double criminality of the act, give rise to surrender pursuant to an arrest warrant:- participation in a criminal organisation,- terrorism,- trafficking in human beings,- sexual exploitation of children and child pornography,- illicit trafficking in narcotic drugs and psychotropic substances,- illicit trafficking in weapons, munitions and explosives,- corruption,- fraud, including that affecting the financial interests of the European Communities within the meaning of the Convention of 26 July 1995 on the protection of the European Communities' financial interests,- laundering of the proceeds of crime,- counterfeiting currency, including of the euro,- computer-related crime,- environmental crime, including illicit trafficking in endangered animal species and in endangered plant species and varieties,- facilitation of unauthorised entry and residence,- murder, grievous bodily injury,- illicit trade in human organs and tissue,- kidnapping, illegal restraint and hostage-taking,- racism and xenophobia,- organised or armed robbery,- illicit trafficking in cultural goods, including antiques and works of art,- swindling,- racketeering and extortion,- counterfeiting and piracy of products,- forgery of administrative documents and trafficking therein,- forgery of means of payment,- illicit trafficking in hormonal substances and other growth promoters,- illicit trafficking in nuclear or radioactive materials,- trafficking in stolen vehicles,- rape,- arson,- crimes within the jurisdiction of the International Criminal Court,- unlawful seizure of aircraft/ships,- sabotage.Article 4Grounds for mandatory non-execution of the arrest warrantStates shall establish an obligation for the executing judicial authority to refuse to execute the arrest warrant in the following cases:1) if the offence on which the arrest warrant is based is covered by amnesty in the executing State, where that State had jurisdiction to prosecute the offence under its own criminal law;2) if the executing judicial authority is informed that the requested person has been finally judged by a State in respect of the same acts provided that, where there has been sentence, the sentence has been served or is currently being served or may no longer be executed under the law of the sentencing State;3) if the person who is the subject of the arrest warrant may not, owing to his age, be held criminally responsible for the acts on which the arrest warrant is based under the law of the executing State.Article 5Other grounds for non-execution of the arrest warrant1. States can establish an obligation or an option for the executing judicial authority to refuse to execute the arrest warrant in the following cases:(a) if, in one of the cases referred to in Article 3(2), the act on which the arrest warrant is based does not constitute an offence under the law of the executing State; however, in relation to taxes or duties, customs and exchange, execution of the arrest warrant shall not be refused on the ground that the law of the executing State does not impose the same kind of tax or duty or does not contain the same type of rules as regards taxes, duties and customs and exchange regulations as the law of the issuing State;(b) where the person who is the subject of the arrest warrant is being prosecuted in the executing State for the same act as that on which the arrest warrant is based;(c) where the judicial authorities of the executing State have decided either not to prosecute for the offence on which the arrest warrant is based or to halt proceedings, or where a final judgement has been passed upon the requested person in a State, in respect of the same acts, which prevents further proceedings;(d) where the criminal prosecution or punishment of the requested person is statute-barred according to the law of the executing State and the acts fall within the jurisdiction of that State under its own criminal law;(e) if the executing judicial authority is informed that the requested person has been finally judged by a third State in respect of the same acts provided that, where there has been sentence, the sentence has been served or is currently being served or may no longer be executed under the law of the sentencing country;(f) if the arrest warrant has been issued for the purposes of execution of a custodial sentence or detention order, where the requested person is staying in, or is a national or a resident of the executing State and that State undertakes to execute the sentence or detention order in accordance with its domestic law;(g) where the arrest warrant relates to offences which:(i) are regarded by the law of the executing State as having been committed in whole or in part in the territory of the executing State or in a place treated as such;or(ii) have been committed outside the territory of the issuing State and the law of the executing State does not allow prosecution for the same offences when committed outside its territory.2. Each State shall inform the General Secretariat of the Council for which of the grounds of non-execution of paragraph 1, it has established an obligation for its executing judicial authorities to refuse the execution of an arrest warrant. The General Secretariat shall make the information received available to all States and the Commission.Article 6Political offence exception1. Execution may not be refused on the ground that the offence may be regarded by the executing State as a political offence, as an offence connected with a political offence or an offence inspired by political motives.2. Norway and Iceland, on the one hand, and the European Union, on behalf of any of its Member States, on the other hand, may make, however, a declaration to the effect that paragraph 1 will be applied only in relation to:(a) the offences referred to in Articles 1 and 2 of the European Convention on the Suppression of Terrorism;(b) offences of conspiracy or association — which correspond to the description of behaviour referred to in Article 3(3) — to commit one or more of the offences referred to in Articles 1 and 2 of the European Convention on the Suppression of Terrorism;and(c) Articles 1, 2, 3 and 4 of the Framework Decision of 13 June 2002 on combating terrorism.3. Where an arrest warrant has been issued by a State having made a declaration as referred to in paragraph 2, or by a State on behalf of which such a declaration has been made, the State executing the arrest warrant, may apply reciprocity.Article 7Nationality exception1. Execution may not be refused on the ground that the person claimed is a national of the executing State.2. Norway and Iceland, on the one hand, and the European Union, on behalf of any of its Member States, on the other hand, may make a declaration to the effect that nationals will not be surrendered or that surrender will be authorised only under certain specified conditions.3. Where an arrest warrant has been issued by a State having made a declaration as referred to in paragraph 2, or by a State for which such a declaration has been made, any other State may, in the execution of the arrest warrant, apply reciprocity.Article 8Guarantees to be given by the issuing State in particular casesThe execution of the arrest warrant by the executing judicial authority may be subject to the following conditions:1) where the arrest warrant has been issued for the purposes of executing a sentence or a detention order imposed by a decision rendered in absentia and if the person concerned has not been summoned in person or otherwise informed of the date and place of the hearing which led to the decision rendered in absentia, surrender may be subject to the condition that the issuing judicial authority gives an assurance deemed adequate to guarantee the person who is the subject of the arrest warrant that he or she will have an opportunity to apply for a retrial of the case in the issuing State and to be present at the judgment;2) if the offence on the basis of which the arrest warrant has been issued is punishable by custodial life sentence or life-time detention order the execution of the said arrest warrant may be subject to the condition that the issuing State gives an assurance deemed sufficient by the executing state that it will review the penalty or measure imposed, on request or at the latest after 20 years, or will encourage the application of measures of clemency to which the person is entitled to apply for under the law or practice of the issuing State, aiming at a non-execution of such penalty or measure;3) where a person who is the subject of an arrest warrant for the purposes of prosecution is a national or resident of the executing State, surrender may be subject to the condition that the person, after being heard, is returned to the executing State in order to serve there the custodial sentence or detention order passed against him in the issuing State.Article 9Determination of the competent judicial authorities1. The issuing judicial authority shall be the judicial authority of the issuing State which is competent to issue an arrest warrant by virtue of the law of that State.2. The executing judicial authority shall be the judicial authority of the executing State which is competent to execute the arrest warrant by virtue of the law of that State. At the moment of notification referred to in Article 38(1), a Minister of Justice may be designated as a competent authority for the execution of an arrest warrant, whether or not the Minister of Justice is a judicial authority under the domestic law of that State.3. The Contracting Parties shall inform each other of their competent authorities.Article 10Recourse to the central authority1. The Contracting Parties may notify each other of the central authority for each State, having designated such an authority, or, when the legal system of the relevant State so provides, of more than one central authority to assist the competent judicial authorities.2. In doing so the Contracting Parties may indicate that, as a result of the organisation of the internal judicial system of the relevant States, the central authority(ies) are responsible for the administrative transmission and reception of arrest warrants as well as for all other official correspondence relating thereto. These indications shall be binding upon all the authorities of the issuing State.Article 11Content and form of the arrest warrant1. The arrest warrant shall contain the following information set out in accordance with the form contained in the Annex to this Agreement:(a) the identity and nationality of the requested person;(b) the name, address, telephone and fax numbers and e-mail address of the issuing judicial authority;(c) evidence of an enforceable judgement, an arrest warrant or any other enforceable judicial decision having the same effect, coming within the scope of Articles 2 and 3;(d) the nature and legal classification of the offence, particularly in respect of Article 3;(e) a description of the circumstances in which the offence was committed, including the time, place and degree of participation in the offence by the requested person;(f) the penalty imposed, if there is a final judgment, or the prescribed scale of penalties for the offence under the law of the issuing State;(g) if possible, other consequences of the offence.2. The arrest warrant must be translated into the official language or one of the official languages of the executing State. Any Contracting Party may, when this Agreement is concluded or at a later date, make a declaration to the effect that a translation in one or more other official languages of a State will be accepted.CHAPTER 2SURRENDER PROCEDUREArticle 12Transmission of an arrest warrant1. When the location of the requested person is known, the issuing judicial authority may transmit the arrest warrant directly to the executing judicial authority.2. The issuing judicial authority may, in any event, decide to issue an alert for the requested person in the Schengen Information System (SIS).Such an alert shall be effected in accordance with the relevant provisions of European Union law on alerts in the Schengen Information System on persons for the purpose of surrender. An alert in the Schengen Information System shall be equivalent to an arrest warrant accompanied by the information set out in Article 11(1).3. For a transitional period, until the SIS is capable of transmitting all the information described in Article 11, the alert shall be equivalent to an arrest warrant pending the receipt of the original in due and proper form by the executing judicial authority.Article 13Detailed procedures for transmitting an arrest warrant1. If the issuing judicial authority does not know the competent executing judicial authority, it shall make the requisite enquiries, in order to obtain that information from the executing State.2. If it is not possible to call on the services of the SIS, the issuing judicial authority may call on the International Criminal Police Organisation (Interpol) to transmit an arrest warrant.3. The issuing judicial authority may forward the arrest warrant by any secure means capable of producing written records under conditions allowing the executing State to establish its authenticity.4. All difficulties concerning the transmission or the authenticity of any document needed for the execution of the arrest warrant shall be dealt with by direct contacts between the judicial authorities involved, or, where appropriate, with the involvement of the central authorities of the States.5. If the authority which receives an arrest warrant is not competent to act upon it, it shall automatically forward the arrest warrant to the competent authority in its State and shall inform the issuing judicial authority accordingly.Article 14Rights of a requested person1. When a requested person is arrested, the executing competent judicial authority shall, in accordance with its national law, inform that person of the arrest warrant and of its contents, and also of the possibility of consenting to surrender to the issuing judicial authority.2. A requested person who is arrested for the purpose of the execution of an arrest warrant shall have a right to be assisted by a legal counsel and by an interpreter in accordance with the national law of the executing State.Article 15Keeping the person in detentionWhen a person is arrested on the basis of an arrest warrant, the executing judicial authority shall take a decision on whether the requested person should remain in detention, in accordance with the law of the executing State. The person may be released provisionally at any time in conformity with the domestic law of the executing State, provided that the competent authority of the said State takes all the measures it deems necessary to prevent the person absconding.Article 16Consent to surrender1. If the arrested person indicates that he or she consents to surrender, that consent and, if appropriate, express renunciation of entitlement to the "speciality rule", referred to in Article 30(2), shall be given before the executing judicial authority, in accordance with the domestic law of the executing State.2. Each State shall adopt the measures necessary to ensure that consent and, where appropriate, renunciation, as referred to in paragraph 1, are established in such a way as to show that the person concerned has expressed them voluntarily and in full awareness of the consequences. To that end, the requested person shall have the right to legal counsel.3. The consent and, where appropriate, renunciation, as referred to in paragraph 1, shall be formally recorded in accordance with the procedure laid down by the domestic law of the executing State.4. In principle, consent may not be revoked. Each State may provide that consent and, if appropriate, renunciation may be revoked, in accordance with the rules applicable under its domestic law. In this case, the period between the date of consent and that of its revocation shall not be taken into consideration in establishing the time limits laid down in Article 20. Norway and Iceland, on the one hand, and the European Union, on behalf of any of its Member States, on the other hand, may make, at the time of notification provided for in Article 38(1), a declaration indicating that they wish to have recourse to this possibility, specifying the procedures whereby revocation of consent shall be possible and any amendment to them.Article 17Hearing of the requested personWhere the arrested person does not consent to his or her surrender as referred to in Article 16, he or she shall be entitled to be heard by the executing judicial authority, in accordance with the law of the executing State.Article 18Surrender decision1. The executing judicial authority shall decide, within the time limits and under the conditions defined in this Agreement, whether the person is to be surrendered.2. If the executing judicial authority finds the information communicated by the issuing State to be insufficient to allow it to decide on surrender, it shall request that the necessary supplementary information, in particular with respect to Articles 4 to 6, 8 and 11, be furnished as a matter of urgency and may fix a time limit for the receipt thereof, taking into account the need to observe the time limits set in Article 20.3. The issuing judicial authority may at any time forward any additional useful information to the executing judicial authority.Article 19Decision in the event of multiple requests1. If two or more States have issued a European arrest warrant or an arrest warrant for the same person, the decision as to which of the arrest warrants shall be executed shall be taken by the executing judicial authority with due consideration of all the circumstances and especially the relative seriousness and place of the offences, the respective dates of the arrest warrants and whether the warrant has been issued for the purposes of prosecution or for execution of a custodial sentence or detention order.2. The executing judicial authority of a Member State may seek the advice of Eurojust when making the choice referred to in paragraph 1.3. In the event of a conflict between an arrest warrant and a request for extradition presented by a third State, the decision as to whether the arrest warrant or the extradition request takes precedence shall be taken by the competent authority of the executing State with due consideration of all the circumstances, in particular those referred to in paragraph 1 and those mentioned in the applicable convention.4. This Article shall be without prejudice to States' obligations under the Statute of the International Criminal Court.Article 20Time limits and procedures for the decision to execute the arrest warrant1. An arrest warrant shall be dealt with and executed as a matter of urgency.2. In cases where the requested person consents to his surrender, the final decision on the execution of the arrest warrant should be taken within a period of 10 days after consent has been given.3. In other cases, the final decision on the execution of the arrest warrant should be taken within a period of 60 days after the arrest of the requested person.4. Where in specific cases the arrest warrant cannot be executed within the time limits laid down in paragraphs 2 or 3, the executing judicial authority shall immediately inform the issuing judicial authority thereof, giving the reasons for the delay. In such case, the time limits may be extended by a further 30 days.5. The European Union, on behalf of any of its Member States, may make, at the time of notification provided for in Article 38(1), a declaration indicating in which cases paragraphs 3 and 4 will not apply. Norway and Iceland may apply reciprocity in relation to the Member States concerned.6. As long as the executing judicial authority has not taken a final decision on the arrest warrant, it shall ensure that the material conditions necessary for effective surrender of the person remain fulfilled.7. Reasons must be given for any refusal to execute an arrest warrant.Article 21Situation pending the decision1. Where the arrest warrant has been issued for the purpose of conducting a criminal prosecution, the executing judicial authority must:(a) either agree that the requested person should be heard according to Article 22;(b) or agree to the temporary transfer of the requested person.2. The conditions and the duration of the temporary transfer shall be determined by mutual agreement between the issuing and executing judicial authorities.3. In the case of temporary transfer, the person must be able to return to the executing State to attend hearings concerning him or her as part of the surrender procedure.Article 22Hearing the person pending the decision1. The requested person shall be heard by a judicial authority, assisted by another person designated in accordance with the law of the State of the requesting court.2. The requested person shall be heard in accordance with the law of the executing State and with the conditions determined by mutual agreement between the issuing and executing judicial authorities.3. The competent executing judicial authority may assign another judicial authority of its State to take part in the hearing of the requested person in order to ensure the proper application of this Article and of the conditions laid down.Article 23Privileges and immunities1. Where the requested person enjoys a privilege or immunity regarding jurisdiction or execution in the executing State, the time limits referred to in Article 20 shall not start running unless, and counting from the day when, the executing judicial authority is informed of the fact that the privilege or immunity has been waived.2. The executing State shall ensure that the material conditions necessary for effective surrender are fulfilled when the person no longer enjoys such privilege or immunity.3. Where power to waive the privilege or immunity lies with an authority of the executing State, the executing judicial authority shall request it to exercise that power forthwith. Where power to waive the privilege or immunity lies with an authority of another State or international organisation, it shall be for the issuing judicial authority to request it to exercise that power.Article 24Competing international obligationsThis Agreement shall not prejudice the obligations of the executing State where the requested person has been extradited to that State from a third State and where that person is protected by provisions of the arrangement under which he or she was extradited concerning speciality. The executing State shall take all necessary measures for requesting forthwith the consent of the State from which the requested person was extradited so that he or she can be surrendered to the State which issued the arrest warrant. The time limits referred to in Article 20 shall not start running until the day on which these speciality rules cease to apply.Pending the decision of the State from which the requested person was extradited, the executing State will ensure that the material conditions necessary for effective surrender remain fulfilled.Article 25Notification of the decisionThe executing judicial authority shall notify the issuing judicial authority immediately of the decision on the action to be taken on the arrest warrant.Article 26Time limits for surrender of the person1. The person requested shall be surrendered as soon as possible on a date agreed between the authorities concerned.2. He or she shall be surrendered no later than 10 days after the final decision on the execution of the arrest warrant.3. If the surrender of the requested person within the period laid down in paragraph 2 is prevented by circumstances beyond the control of any of the States, the executing and issuing judicial authorities shall immediately contact each other and agree on a new surrender date. In that event, the surrender shall take place within 10 days of the new date thus agreed.4. The surrender may exceptionally be temporarily postponed for serious humanitarian reasons, for example if there are substantial grounds for believing that it would manifestly endanger the requested person's life or health. The execution of the arrest warrant shall take place as soon as these grounds have ceased to exist. The executing judicial authority shall immediately inform the issuing judicial authority and agree on a new surrender date. In that event, the surrender shall take place within 10 days of the new date thus agreed.5. Upon expiry of the time limits referred to in paragraphs 2 to 4, if the person is still being held in custody he shall be released.Article 27Postponed or conditional surrender1. The executing judicial authority may, after deciding to execute the arrest warrant, postpone the surrender of the requested person so that he or she may be prosecuted in the executing State or, if he or she has already been sentenced, so that he or she may serve, in its territory, a sentence passed for an act other than that referred to in the arrest warrant.2. Instead of postponing the surrender, the executing judicial authority may temporarily surrender the requested person to the issuing State under conditions to be determined by mutual agreement between the executing and the issuing judicial authorities. The agreement shall be made in writing and the conditions shall be binding on all the authorities in the issuing State.Article 28Transit1. Each State shall permit the transit through its territory of a requested person who is being surrendered provided that it has been given information on:(a) the identity and nationality of the person subject to the arrest warrant;(b) the existence of an arrest warrant;(c) the nature and legal classification of the offence;(d) the description of the circumstances of the offence, including the date and place.The State, on behalf of which a declaration has been made in accordance with Article 7(2), to the effect that nationals will not be surrendered or that surrender will be authorised only under certain specified conditions, may, under the same terms, refuse the transit of its nationals through its territory or submit it to the same conditions.2. The Contracting Parties shall notify each other of the authority designated for each State responsible for receiving transit requests and the necessary documents, as well as any other official correspondence relating to transit requests.3. The transit request and the information set out in paragraph 1 may be addressed to the authority designated pursuant to paragraph 2 by any means capable of producing a written record. The State of transit shall notify its decision by the same procedure.4. This Agreement does not apply in the case of transport by air without a scheduled stopover. However, if an unscheduled landing occurs, the issuing State shall provide the authority designated pursuant to paragraph 2 with the information provided for in paragraph 1.5. Where a transit concerns a person who is to be extradited from a third State to a State this Article will apply mutatis mutandis. In particular the expression "arrest warrant" as defined by this Agreement shall be deemed to be replaced by "extradition request".CHAPTER 3EFFECTS OF THE SURRENDERArticle 29Deduction of the period of detention served in the executing State1. The issuing State shall deduct all periods of detention arising from the execution of an arrest warrant from the total period of detention to be served in the issuing State as a result of a custodial sentence or detention order being passed.2. To that end, all information concerning the duration of the detention of the requested person on the basis of the arrest warrant shall be transmitted by the executing judicial authority or the central authority designated under Article 10 to the issuing judicial authority at the time of the surrender.Article 30Possible prosecution for other offences1. Norway and Iceland, on the one hand, and the European Union, on behalf of any of its Member States, on the other hand, may notify each other that, for relations of States with other States to which the same notification applies, consent is presumed to have been given for the prosecution, sentencing or detention with a view to the carrying out of a custodial sentence or detention order for an offence committed prior to his or her surrender, other than that for which he or she was surrendered, unless in a particular case the executing judicial authority states otherwise in its decision on surrender.2. Except in the cases referred to in paragraphs 1 and 3, a person surrendered may not be prosecuted, sentenced or otherwise deprived of his or her liberty for an offence committed prior to his or her surrender other than that for which he or she was surrendered.3. Paragraph 2 does not apply in the following cases:(a) when the person having had an opportunity to leave the territory of the State to which he or she has been surrendered has not done so within 45 days of his or her final discharge, or has returned to that territory after leaving it;(b) the offence is not punishable by a custodial sentence or detention order;(c) the criminal proceedings do not give rise to the application of a measure restricting personal liberty;(d) when the person could be liable to a penalty or a measure not involving the deprivation of liberty, in particular a financial penalty or a measure in lieu thereof, even if the penalty or measure may give rise to a restriction of his or her personal liberty;(e) when the person consented to be surrendered, where appropriate at the same time as he or she renounced the speciality rule, in accordance with Article 16;(f) when the person, after his/her surrender, has expressly renounced entitlement to the speciality rule with regard to specific offences preceding his/her surrender. Renunciation shall be given before the competent judicial authorities of the issuing State and shall be recorded in accordance with that State's domestic law. The renunciation shall be drawn up in such a way as to make clear that the person has given it voluntarily and in full awareness of the consequences. To that end, the person shall have the right to legal counsel;(g) where the executing judicial authority which surrendered the person gives its consent in accordance with paragraph 4.4. A request for consent shall be submitted to the executing judicial authority, accompanied by the information mentioned in Article 11(1) and a translation as referred to in Article 11(2). Consent shall be given when the offence for which it is requested is itself subject to surrender in accordance with the provisions of this Agreement. Consent shall be refused on the grounds referred to in Article 4 and otherwise may be refused only on the grounds referred to in Articles 5, or 6(2) and 7(2). The decision shall be taken no later than 30 days after receipt of the request. For the situations mentioned in Article 8 the issuing State must give the guarantees provided for therein.Article 31Surrender or subsequent extradition1. Norway and Iceland, on the one hand, and the European Union, on behalf of any of its Member States, on the other hand, may notify each other that, for relations of States with other States to which the same notification applies, the consent for the surrender of a person to a State other than the executing State pursuant to an arrest warrant issued for an offence committed prior to his or her surrender is presumed to have been given, unless in a particular case the executing judicial authority states otherwise in its decision on surrender.2. In any case, a person who has been surrendered to the issuing State pursuant to an arrest warrant may, without the consent of the executing State, be surrendered to a State other than the executing State pursuant to an arrest warrant issued for any offence committed prior to his or her surrender in the following cases:(a) where the requested person, having had an opportunity to leave the territory of the State to which he or she has been surrendered, has not done so within 45 days of his final discharge, or has returned to that territory after leaving it;(b) where the requested person consents to be surrendered to a State other than the executing State pursuant to an arrest warrant. Consent shall be given before the competent judicial authorities of the issuing State and shall be recorded in accordance with that State's national law. It shall be drawn up in such a way as to make clear that the person concerned has given it voluntarily and in full awareness of the consequences. To that end, the requested person shall have the right to legal counsel;(c) where the requested person is not subject to the speciality rule, in accordance with Article 30(3)(a), (e), (f) and (g).3. The executing judicial authority consents to the surrender to another State according to the following rules:(a) the request for consent shall be submitted in accordance with Article 12, accompanied by the information mentioned in Article 11(1) and a translation as stated in Article 11(2);(b) consent shall be given when the offence for which it is requested is itself subject to surrender in accordance with the provisions of this Agreement;(c) the decision shall be taken no later than 30 days after receipt of the request;(d) consent shall be refused on the grounds referred to in Article 4 and otherwise may be refused only on the grounds referred to in Articles 5 or 6(2) and 7(2).For the situations referred to in Article 8, the issuing State must give the guarantees provided for therein.4. Notwithstanding paragraph 1, a person who has been surrendered pursuant to an arrest warrant shall not be extradited to a third State without the consent of the competent authority of the State which surrendered the person. Such consent shall be given in accordance with the Conventions by which that State is bound, as well as with its domestic law.Article 32Handing over of property1. At the request of the issuing judicial authority or on its own initiative, the executing judicial authority shall, in accordance with its national law, seize and hand over property which:(a) may be required as evidence; or(b) has been acquired by the requested person as a result of the offence.2. The property referred to in paragraph 1 shall be handed over even if the arrest warrant cannot be carried out owing to the death or escape of the requested person.3. If the property referred to in paragraph 1 is liable to seizure or confiscation in the territory of the executing State, the latter may, if the property is needed in connection with pending criminal proceedings, temporarily retain it or hand it over to the issuing State, on condition that it is returned.4. Any rights which the executing State or third parties may have acquired in the property referred to in paragraph 1 shall be preserved. Where such rights exist, the issuing State shall return the property without charge to the executing State as soon as the criminal proceedings have been terminated.Article 33Expenses1. Expenses incurred in the territory of the executing State for the execution of an arrest warrant shall be borne by that State.2. All other expenses shall be borne by the issuing State.CHAPTER 4GENERAL AND FINAL PROVISIONSArticle 34Relation to other legal instruments1. Without prejudice to their application in relations between States and third States, this Agreement shall, from its entry into force, replace the corresponding provisions of the following conventions applicable in the field of extradition in relations between Norway and Iceland, on the one hand, and Member States, on the other hand:(a) the European Convention on Extradition of 13 December 1957, its additional protocol of 15 October 1975, its second additional protocol of 17 March 1978, and the European Convention on the suppression of terrorism of 27 January 1977 as far as extradition is concerned as amended by the 2003 Protocol once it will enter into force;(b) Title III, Chapter 4 of the Convention of 19 June 1990 implementing the Schengen Agreement of 14 June 1985 on the gradual abolition of checks at common borders;(c) Schengen-relevant provisions of the 1995 and 1996 EU Extradition Conventions to the extent that they are in force.2. States may continue to apply bilateral or multilateral agreements or arrangements in force when this Agreement is concluded in so far as such agreements or arrangements allow the objectives of this Agreement to be extended or enlarged and help to simplify or facilitate further the procedures for surrender of persons who are the subject of an arrest warrant. The Contracting Parties shall notify each other of any such agreements or arrangements.3. States may conclude bilateral or multilateral agreements or arrangements after this Agreement has come into force in so far as such agreements or arrangements allow the prescriptions of this Agreement to be extended or enlarged and help to simplify or facilitate further the procedures for surrender of persons who are the subject of an arrest warrant, in particular by fixing time limits shorter than those fixed in Article 20, by extending the list of offences laid down in Article 3(4), by further limiting the grounds for refusal set out in Articles 4 and 5, or by lowering the threshold provided for in Article 3(1) or (4).The agreements and arrangements referred to in the first subparagraph may in no case affect relations with States which are not parties to them.The Contracting Parties shall also notify each other of any such new agreement or arrangement as referred to in the first subparagraph, within three months of signing it.4. Where the conventions or agreements referred to in paragraph 1 apply to the territories of States or to territories for whose external relations a State is responsible to which this Agreement does not apply, these instruments shall continue to govern the relations existing between those territories and the other States.Article 35Transitional provision1. Extradition requests received before the date of entry into force of this Agreement will continue to be governed by existing instruments relating to extradition. Requests received after that date will be governed by this Agreement.2. Norway and Iceland, on the one hand, and the European Union, on behalf of any of its Member States, on the other hand, may, at the time of the notification provided for in Article 38(1), make a statement indicating that, as executing State, the State will continue to apply the extradition system applicable before the entry into force of this Agreement in relation to acts committed before a date which it specifies. The date in question may not be later than the entry into force of this Agreement. The said statement may be withdrawn at any time.Article 36Dispute settlementAny dispute between either Iceland or Norway and a Member State of the European Union regarding the interpretation or the application of this Agreement may be referred by a party to the dispute to a meeting of representatives of the governments of the Member States of the European Union and of Iceland and Norway, with a view to its settlement within six months.Article 37Case lawThe Contracting Parties, in order to achieve the objective of arriving at as uniform an application and interpretation as possible of the provisions of this Agreement, shall keep under constant review the development of the case law of the Court of Justice of the European Communities, as well as the development of the case law of the competent courts of Iceland and Norway relating to these provisions and to those of similar surrender instruments. To this end a mechanism shall be set up to ensure regular mutual transmission of such case law.Article 38Notifications, declarations, entry into force1. The Contracting Parties shall notify each other of the completion of the procedures required to express their consent to be bound by this Agreement.2. When giving their notification under paragraph 1 the Contracting Parties shall make any of the notifications or declarations provided for in Articles 5(2), 9(3), 28(2) and 34(2) of this Agreement and may make any of the notifications or declarations provided for in Articles 3(4), 6(2), 7(2), 10(1), 11(2), 16(4), 20(5), 30(1), 31(1) and 35(2) of this Agreement. The declarations or notifications referred to in Articles 3(4), 10(1) and 11(2) may be made at any time. The declarations or notifications referred to in Articles 9(3) and 28(2) may be modified, and those referred to in Articles 5(2), 6(2), 7(2), 10(1), 16(4), 20(5), 34(2) and 35(2) withdrawn, at all times.3. Where the European Union makes such declarations or notifications it shall indicate for which of its Member States the declaration applies.4. This Agreement shall enter into force on the first day of the third month following the day on which the Secretary-General of the Council of the European Union has established that all formal requirements concerning the expression of the consent by the Contracting Parties to this Agreement have been fulfilled.Article 39AccessionAccession by new Member States to the European Union shall create rights and obligations under the present Agreement between those new Member States and Iceland and Norway.Article 40Common reviewThe Contracting Parties agree to carry out a common review of this Agreement no later than five years after its entry into force, and in particular of the declarations made under Articles 3(4), 6(2), 7(2) and 20(5) of this Agreement. Where the declarations referred to in Article 7(2) are not renewed, they shall expire five years after the entry into force of this Agreement. The review shall in particular address the practical implementation, interpretation and development of the Agreement and may also include issues such as the consequences of further development of the European Union relating to the subject matter of this Agreement.Article 41Termination1. This Agreement may be terminated by the Contracting Parties. In the event of termination by either Iceland or Norway, this Agreement shall remain in force between the European Union and the Contracting Party for which it has not been terminated.2. Termination of this Agreement pursuant to paragraph 1 shall take effect six months after the deposit of the notification of termination. Procedures for complying with requests for surrender still pending at that date shall be completed in conformity with the provisions of this Agreement.Article 42Depository1. The Secretary General of the Council of the European Union shall act as the depository of this Agreement.2. The depository shall make public information on any notification or declaration made concerning this Agreement.Done at Vienna on 28 June 2006 in one single copy in the Icelandic, Norwegian, Czech, Danish, Dutch, German, English, Estonian, French, Finnish, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Slovak, Slovenian, Spanish and Swedish languages, each version being equally authentic.Fyrir hönd EvrópusambandsinsFor Den europeiske unionPor la Unión EuropeaZa Evropskou uniiFor den Europæiske UnionFür die Europäische UnionEuroopa Liidu nimelΓια την Ευρωπαϊκή ΈνωσηFor the European UnionPour l'Union européenneThar ceann an Aontais EorpaighPer l'Unione europeaEiropas Savienības vārdāEuropos Sąjungos varduAz Európai Unió részérőlGħall-Unjoni EwropeaVoor de Europese UnieW imieniu Unii EuropejskiejPela União EuropeiaZa Európsku úniuZa Evropsko unijoEuroopan unionin puolestaPå Europeiska unionens vägnar+++++ TIFF +++++Fyrir hönd lýðveldisins ÍslandsFor Republikken IslandPor la República de IslandiaZa Islandskou republikuFor Republikken IslandFür die Republik IslandIslandi Vabariigi nimelΓια τη Δημοκρατία της ΙσλανδίαςFor the Republic of IcelandPour la République d'IslandeThar ceann Phoblacht na hÍoslainnePer la Repubblica d'IslandaIslandes Republikas vārdāIslandijos Respublikos varduAz Izlandi Köztársaság részérőlGhar-Repubblika ta' l-IżlandaVoor de Republiek IjslandW imieniu Republiki IslandiiPela República da IslândiaZa Islandskú republikuZa Republiko IslandijoIslannin tasavallan puolestaPå Republiken Islands vägnar+++++ TIFF +++++Fyrir hönd Konungsríkisins NoregsFor Kongeriket NorgePor el Reino de NoruegaZa Norské královstviFor Kongeriget NorgeFür das Königreich NorwegenNorra Kuningriigi nimelΓια το Βασίλειο της ΝορβηγίαςFor the Kingdom of NorwayPour le Royaume de NorvègeThar ceann Ríocht na hIoruaPer il Regno di NorvegiaNorvēģijas Karalistes vārdāNorvegijos Karalystės varduA Norvég Királyság részérőlGhar-Renju tan-NorveġjaVoor het Koninkrijk NoorwegenW imieniu Królestwa NorwegiiPelo Reino da NoruegaZa Nórske kráľovstvoZa Kraljevino NorveškoNorjan kuningaskunnan puolestaPå Konungariket Norges vägnar+++++ TIFF +++++--------------------------------------------------

Surrender procedure between EU Member States and Iceland and Norway Surrender procedure between EU Member States and Iceland and Norway SUMMARY OF: Agreement between the EU and Iceland and Norway on the surrender procedure between the EU Member States and Iceland and Norway Decision 2006/697/EC on the signing of the Agreement between the EU and Iceland and Norway on the surrender procedure between the EU Member States and Iceland and Norway Decision 2014/835/EU on the conclusion of the Agreement between the European Union and the Republic of Iceland and the Kingdom of Norway on the surrender procedure between the Member States of the European Union and Iceland and Norway WHAT IS THE AIM OF THE AGREEMENT AND DECISIONS? The object of this agreement is to improve judicial cooperation in criminal matters between the EU Member States and Iceland and Norway. It aims to set up a surrender procedure* to speed up the transfer of suspected and convicted persons and to ensure sufficient controls on carrying out European arrest warrants. The parties to the agreement undertake to respect fundamental rights, to protect personal data and to refuse to surrender any person based on discriminatory reasons. They also express their mutual confidence in their legal systems and their ability to guarantee a fair trial. Decision 2006/697/EC approves the signing of the agreement on behalf of the EU, subject to its being concluded. Decision 2014/835/EU approves the agreement on the surrender procedure between the Member States and Iceland and Norway. KEY POINTS Arrest warrant An arrest warrant may be issued for offences punishable by a custodial sentence or detention order of at least 12 months, or 4 months where a sentence has already been passed or a detention order made. The arrest warrant containing details of the identity of the requested person, the issuing authority, the sentence and the nature of the offence is transmitted as soon as the requested person is found, and communicated to the Schengen Information System (SIS) or, if this is not possible, to Interpol. If the person consents to the surrender, the final decision to carry out the arrest warrant should be taken within 10 days after consent has been given. In other cases, the final decision on carrying out the arrest warrant should be taken within 60 days after the arrest. In some circumstances this can be extended by 30 days. Double criminality For offences punishable by a custodial sentence of at least 3 years, the parties can declare that they do not require the condition of double criminality* for 32 categories of offences as long as the offences carry a sentence of at least 3 years. These offences include: participation in a criminal organisation, terrorism, trafficking in human beings, sexual exploitation of children and child pornography, illicit trafficking in narcotic drugs and psychotropic substances, illicit trafficking in weapons, munitions and explosives, corruption, fraud, including that affecting the EU’s financial interests, laundering of the proceeds of crime, counterfeiting currency, including of the euro, computer-related crime, environmental crime, including illicit trafficking in endangered animal species and in endangered plant species and varieties, facilitation of unauthorised entry and residence, murder, grievous bodily injury, illicit trade in human organs and tissue, kidnapping, illegal restraint and hostage-taking, racism and xenophobia, organised or armed robbery, illicit trafficking in cultural goods, including antiques and works of art, swindling, racketeering and extortion, counterfeiting and piracy of products, forgery of administrative documents and trafficking therein, forgery of means of payment, illicit trafficking in hormonal substances and other growth promoters, illicit trafficking in nuclear or radioactive materials, trafficking in stolen vehicles, rape, arson, crimes within the jurisdiction of the International Criminal Court, unlawful seizure of aircraft/ships, sabotage. Grounds for not executing an arrest warrant Mandatory grounds for refusal: Judicial authorities will refuse to carry out an arrest warrant if: the offence is covered by an amnesty; the person has already been tried for the same offence and has served or is serving their sentence; the person cannot be held criminally responsible because of their age. Optional grounds for refusal: Countries can refuse to carry out an arrest warrant if: the acts are not an offence in the country being asked to carry out the arrest warrant, that is, the executing state (except in relation to taxes, duties, customs and exchange); the person is being prosecuted in the executing state for the same offence; the state has passed a final judgement in respect of the same offence, which prevents further proceedings; the authorities in the executing state have decided not to prosecute the person or have halted proceedings; the criminal prosecution or punishment of the requested person is barred by statute in the executing state; the requested person is a national or resident of the executing state and that state undertakes to carry out the sentence; the offences were committed outside the issuing state or its laws do not permit prosecution for those offences. Fundamental rights The agreement states that it respects fundamental rights and fundamental legal principles laid down in the European Convention on Human Rights, or Article 6 of the Treaty on European Union. It also states it should not be interpreted as prohibiting the refusal to surrender a person: where the arrest warrant may have been issued on the grounds of sex, race, religion, ethnic origin, nationality, language, political opinions or sexual orientation; where that person’s position may be prejudiced for any of these reasons. Political offence exception The executing state may not refuse to carry out an arrest warrant on the grounds that it regards the offence as political. The parties can, however, limit this option to offences covered by Directive (EU) 2017/541 on combating terrorism and by Articles 1 and 2 of the European Convention on the Suppression of Terrorism, 1977. Surrender procedure The arrested person must be informed at the time of the arrest of the contents of the warrant, the possibility of consenting to surrender to the issuing authority, and the right to be assisted by legal counsel and an interpreter. The person may remain in detention or be released provisionally, provided that measures are taken to prevent absconding. The hearing is conducted under the laws of the executing state and in agreed conditions. The person can choose to voluntarily consent to surrender, if this is with full knowledge of the consequences. The person should be surrendered where possible within 10 days of the decision to execute the warrant or of the surrender date agreed between the authorities. The executing authority seizes and hands over property that may serve as evidence or that has been acquired by the person as a result of the offence. The parties will permit the transit through their territory of a person being surrendered, provided that they have full information about the warrant. Expenses All expenses are borne by the issuing state, except those incurred in the territory of the executing state in connection with carrying out an arrest warrant. Disputes and review Any disputes should be referred to a meeting of representatives of the governments of the parties and settled within 6 months. The parties will keep under review the development of the case-law of the Court of Justice of the European Union and of the case-law of the competent courts of Iceland and Norway, and will carry out a review of the agreement no later than 5 years after it comes into force. DATE OF ENTRY INTO FORCE The agreement entered into force on 1 November 2019. BACKGROUND For more information, see: European Arrest Warrant (European e-Justice). KEY TERMS Surrender procedure: a procedure that allows a country to surrender a person to another country for the purpose of conducting a criminal prosecution or executing a custodial sentence or spell in detention. Double criminality: in extradition/surrender law, a feature by which countries can refuse to extradite/surrender persons if the alleged criminal offence in the country requesting the extradition/surrender would not be an offence in the country being asked to carry out the extradition/surrender. MAIN DOCUMENTS Agreement between the European Union and the Republic of Iceland and the Kingdom of Norway on the surrender procedure between the Member States of the European Union and Iceland and Norway (OJ L 292, 21.10.2006, pp. 2-19) Council Decision 2006/697/EC of 27 June 2006 on the signing of the Agreement between the European Union and the Republic of Iceland and the Kingdom of Norway on the surrender procedure between the Member States of the European Union and Iceland and Norway (OJ L 292, 21.10.2006, p.1) Council Decision 2014/835/EU of 27 November 2014 on the conclusion of the Agreement between the European Union and the Republic of Iceland and the Kingdom of Norway on the surrender procedure between the Member States of the European Union and Iceland and Norway (OJ L 343, 28.11.2014, pp. 1-2) RELATED DOCUMENTS Notice concerning the entry into force of the Surrender Agreement between the European Union, Iceland and Norway (OJ L 230, 6.9.2019, p. 1) Directive (EU) 2017/541 of the European Parliament and of the Council of 15 March 2017 on combating terrorism and replacing Council Framework Decision 2002/475/JHA and amending Council Decision 2005/671/JHA (OJ L 88, 31.3.2017, pp. 6-21) last update 06.05.2021

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31.12.2010 EN Official Journal of the European Union L 348/17 REGULATION (EU) No 1236/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 laying down a scheme of control and enforcement applicable in the area covered by the Convention on future multilateral cooperation in the North-East Atlantic fisheries and repealing Council Regulation (EC) No 2791/1999 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof, Having regard to the proposal from the European Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The Convention on future multilateral cooperation in the North-East Atlantic fisheries (the Convention), was approved by the Council in Decision 81/608/EEC (3) and entered into force on 17 March 1982. (2) The Convention provides for an appropriate framework for multilateral cooperation on the rational conservation and management of fishery resources in the Area defined by the Convention (the Convention Area). (3) The North-East Atlantic Fisheries Commission (NEAFC), at its Annual Meeting on 15 November 2006, adopted a recommendation establishing a scheme of control and enforcement (the Scheme) applicable to fishing vessels operating in the waters of the Convention Area which lie beyond the waters under the fisheries jurisdiction of the Contracting Parties (the Regulatory Area). The Scheme, which came into force on 1 May 2007, was amended by several recommendations at the Annual Meetings in November 2007, 2008 and 2009. (4) Under Articles 12 and 15 of the Convention, these recommendations came into force on 9 February 2008, 6 and 8 January 2009, and 6 February 2010 respectively. (5) The Scheme provides for control and enforcement measures applicable to vessels flying the flag of Contracting Parties and operating in the Regulatory Area, and arrangements for inspection at sea which include inspection and surveillance procedures and infringement procedures which must be implemented by the Contracting Parties. (6) The Scheme provides for a new Port State Control system which will effectively close European ports to landings and transhipments of frozen fish which have not been verified to be legal by the flag state of fishing vessels flying the flag of a Contracting Party other than the port state. (7) Certain control provisions adopted by NEAFC have been incorporated into Union law by way of the yearly TAC and quotas Regulation, and most recently by Council Regulation (EC) No 43/2009 of 16 January 2009 fixing for 2009 the fishing opportunities and associated conditions for certain fish stocks and groups of fish stocks, applicable in Community waters and, for Community vessels, in waters where catch limitations are required (4). For the sake of legal certainty, such provisions which are not of a temporary nature should be the subject of a new separate regulation. (8) The Scheme also comprises provisions to promote compliance by vessels flying the flag of a non-Contracting Party with the control and enforcement measures in order to ensure full respect of conservation and management measures adopted by NEAFC. NEAFC recommended removing a number of vessels from the list of vessels that have been confirmed to have engaged in illegal, unreported and unregulated fisheries. The incorporation of those recommendations into Union law should be ensured. (9) Article 5(2) of Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (5) provides that Member States shall control access to waters and resources and control activities outside EU waters carried out by vessels flying their flag. Provision should therefore be made for Member States whose vessels are authorised to fish in the Regulatory Area to assign inspectors to the Scheme to undertake monitoring and surveillance as well as adequate resources for inspection. (10) In order to ensure the monitoring of fishing activities in the Convention Area, it is necessary for Member States to cooperate with one another and with the Commission and the body designated by it in applying the Scheme. (11) It is the responsibility of Member States to ensure that their inspectors comply with the inspection procedures laid down by NEAFC. (12) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) in respect of detailed rules concerning lists of the fishery resources to be notified, procedures for prior notification of entry into port and for the cancellation thereof as well as authorisation to land or tranship. The Commission should also be empowered to adopt delegated acts in respect of the incorporation into Union law of future amendments of those measures of the Scheme which form the subject matter of certain expressly defined non-essential elements of this Regulation and which become binding upon the Union in accordance with the terms of the Convention. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. (13) The measures necessary for the implementation of this Regulation should be adopted by the Commission by means of implementing acts in accordance with Article 291 TFEU. According to that Article, rules and general principles concerning mechanisms for the control by Member States of the Commission’s exercise of implementing powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6) continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable. (14) As this Regulation will establish new rules concerning control and enforcement in the Convention Area, Council Regulation (EC) No 2791/1999 of 16 December 1999 laying down certain control measures applicable in the area covered by the Convention on future multilateral cooperation in the North-East Atlantic fisheries (7) should be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation lays down the general rules and conditions for the application by the Union of the Scheme adopted by NEAFC. Article 2 Scope Unless otherwise stated, this Regulation shall apply to all EU vessels used or intended for use for fishing activities carried out in respect of fishery resources in the Regulatory Area. Article 3 Definitions For the purpose of this Regulation, the following definitions shall apply: 1. ‘Convention’ means the Convention on future multilateral cooperation in North-East Atlantic fisheries, as amended; 2. ‘Convention Area’ means the Convention Area as defined in Article 1(1) of the Convention; 3. ‘Regulatory Area’ means the waters of the Convention Area which lie beyond the waters under the fisheries jurisdiction of the Contracting Parties; 4. ‘Contracting Parties’ means the Contracting Parties to the Convention; 5. ‘NEAFC’ means the North-East Atlantic Fisheries Commission; 6. ‘fishing activities’ means fishing, including joint fishing operations, fish processing operations, the transhipment or landing of fish or fish products and any other commercial activity in preparation for or related to fishing; 7. ‘fishery resources’ means the resources referred to in Article 1(2) of the Convention; 8. ‘regulated resources’ means those fishery resources which are subject to recommendations under the Convention and are listed in the Annex; 9. ‘fishing vessel’ means any vessel used or intended for use for the purposes of the commercial exploitation of fishery resources, including fish processing vessels and vessels engaged in transhipment; 10. ‘non-Contracting Party vessel’ means any fishing vessel not flagged in a Contracting Party, including vessels for which there are reasonable grounds for suspecting them to be without nationality; 11. ‘joint fishing operation’ means any operations between two or more vessels where catch is taken from the fishing gear of one fishing vessel to another; 12. ‘transhipment operation’ means the unloading of all or any fishery products on board a fishing vessel onto another fishing vessel; 13. ‘port’ means any place used for landing or a place close to the shore designated by a Contracting Party for transhipping fishery resources. Article 4 Contact points 1. Member States shall designate the competent authority which shall act as the contact point for the purposes of receiving surveillance and inspection reports in accordance with Articles 12, 19, 20 and 27 and for receiving notifications and issuing authorisations in accordance with Articles 24 and 25. 2. Contact points for receiving notifications and issuing authorisations in accordance with Articles 24 and 25 shall be available 24 hours a day. 3. Member States shall send to the Commission or to the body designated by it and to the NEAFC Secretary the telephone number, e-mail address and fax number of the designated contact point. 4. Any subsequent changes to the information concerning the contact points referred to in paragraphs 1 and 3 shall be notified to the Commission or the body designated by it and to the NEAFC Secretary no later than 15 days before the change comes into force. 5. The format for transmission of the information referred to in paragraphs 1 and 3 shall be established in accordance with Article 50(2). CHAPTER II MONITORING MEASURES Article 5 Union participation 1. Member States shall send to the Commission, in a computer-readable form, a list of all vessels flying their flag and registered in the Union which are authorised to fish in the Regulatory Area, in particular the vessels authorised to fish directly for one or more regulated resources together with any amendments to the list. This information shall be sent no later than 15 December each year or no later than 5 days before the vessel enters the Regulatory Area. The Commission shall forward the information promptly to the NEAFC Secretary. 2. The format for transmission of the list referred to in paragraph 1 shall be determined in accordance with Article 50(2). Article 6 Marking of gear 1. Member States shall ensure that gear used by their fishing vessels in the Regulatory Area is marked in accordance with Commission Regulation (EC) No 356/2005 of 1 March 2005 laying down detailed rules for the marking and identification of passive fishing gear and beam trawls (8). 2. Member States may remove and dispose of fixed gear that is not marked in accordance with Regulation (EC) No 356/2005 or that contravenes in any other way recommendations adopted by NEAFC, as well as fish that are found in the gear. Article 7 Retrieval of lost gear 1. The competent authority of the flag Member State shall send without delay to the NEAFC Secretary the information provided to it pursuant to Article 48(3) of Regulation (EC) No 1224/2009 as well as the call sign of the vessel that has lost the gear. 2. Member States shall undertake to retrieve on a regular basis lost gears belonging to vessels flying their flag. Article 8 Recording of catches 1. In addition to the information specified in Article 6 of Council Regulation (EEC) No 2847/93 of 12 October 1993 establishing a control system applicable to the common fisheries policy (9), the masters of EU fishing vessels shall record, either in a bound paginated fishing logbook or by electronic means, the following: (a) each entry into and exit from the Regulatory Area; (b) on a daily basis and/or for each haul the estimated cumulative catches retained on board since the last entry into the Regulatory Area; (c) on a daily basis and/or for each haul the amount of fish discarded; (d) immediately after each communication pursuant to Article 9, the date and time, according to Universal Coordinated Time (UTC), of transmission of a report and, in the case of radio transmission, the name of the radio station through which the report was transmitted; (e) the fishing depth, where appropriate. 2. The masters of EU fishing vessels engaged in fishing activities carried out in respect of regulated resources and which process and/or freeze their catch shall: (a) record their cumulative production by species and product form in a production logbook; and (b) stow in the hold all processed catch in such a way that the location of each species can be identified from a stowage plan maintained on board the fishing vessel. 3. By way of derogation from paragraph 1, Member States may exempt from the obligation to record in a fishing logbook or electronically a vessel engaged in transhipment operations which on-loads quantities on board. Vessels benefiting from this derogation shall specify in a stowage plan the location in the hold of frozen fish referred to in Article 14(1) and record in a production logbook: (a) the date and time, according to UTC, of transmission of a report referred to in Article 9; (b) in the case of radio transmission, the name of the radio station through which the report was transmitted; (c) the date and time, according to UTC, of the transhipment operation; (d) the location (latitude/longitude) of the transhipment operation; (e) the quantities of each species on-loaded; (f) the name and international radio call sign of the fishing vessel from which the catch has been off-loaded. 4. Detailed rules for the implementation of this Article shall be determined in accordance with Article 50(2). Article 9 Reporting of catches of regulated resources 1. The masters of EU fishing vessels engaged in fishing activities carried out in respect of regulated resources shall communicate catch reports by electronic means to their Fisheries Monitoring Centre, as defined in point (15) of Article 4 of Regulation (EC) No 1224/2009. The data contained in such reports shall be accessible to the Commission on request. Reports shall include the following: (a) reports on the quantities held on board when entering the Regulatory Area. Such reports shall be transmitted no earlier than 12 hours and no later than 2 hours before each entry into the Regulatory Area; (b) reports on weekly catches. Such reports shall be transmitted for the first time no later than the end of the seventh day following the entry of the vessel into the Regulatory Area or, when fishing trips take more than 7 days, no later than Monday noon for catches taken in the Regulatory Area during the preceding week ending at midnight on Sunday. This report shall include the number of fishing days since the start of fishing, or since the last catch report; (c) reports on catches on board when exiting the Regulatory Area. Such reports shall be transmitted no earlier than 8 hours and no later than 2 hours before each departure from the Regulatory Area. Such reports shall include, where appropriate, the number of fishing days and the catch taken in the Regulatory Area since the start of fishing, or since the last catch report; (d) reports on the quantities on-loaded and off-loaded for each transhipment of fish during the vessel’s stay in the Regulatory Area. Donor vessels shall make this report no later than 24 hours before the transhipment, and receiving vessels no later than 1 hour after the transhipment. The report shall include the date, time and geographical position of the planned transhipment as well as the total round weight by species which are to be off-loaded or which have been on-loaded in kilograms and the call signs of the donor and receiving vessels. Without prejudice to Chapter IV, at least 24 hours before any landing, the receiving vessel shall report the total catch on board, the total weight to be landed, the name of the port and the estimated date and time of landing. 2. The reports on catches referred to in this Article shall be expressed in kilograms (rounded to the nearest 100 kg). The total round weight shall be reported by species, using the FAO codes. The total quantity of species for which the total round weight by species is less than 1 tonne may be reported under the 3-alpha code MZZ (marine fish not specified). 3. Member States shall record the data contained in the catch reports in the database referred to in Article 109(1) of Regulation (EC) No 1224/2009. 4. The detailed rules for the implementation of this Article and in particular the format and the specifications for the transmissions shall be determined in accordance with Article 50(2). Article 10 Global reporting of catches and fishing effort 1. Member States shall inform the Commission by computer transmission before the 15th day of each month of the quantities of fishery resources caught in the Regulatory Area by vessels flying their flag which have been landed or transhipped during the preceding month. 2. Without prejudice to Article 33(2) of Regulation (EC) No 1224/2009, Member States shall also inform the Commission by computer transmission before the 15th day of each month of the quantities of regulated resources caught in areas under the national fisheries jurisdiction of third countries and in EU waters of the Convention Area by vessels flying their flag which have been landed or transhipped during the preceding month. 3. The format for transmission of the data pursuant to paragraphs 1 and 2 shall be determined in accordance with Article 50(2). The list of the fishery resources referred to in paragraph 1 shall be adopted in accordance with the procedure laid down in Articles 46 to 49. 4. The Commission shall compile the data referred to in paragraphs 1 and 2 for all Member States and forward them to the NEAFC Secretary within 30 days following the calendar month in which the catches were landed or transhipped. Article 11 Vessel Monitoring System Member States shall ensure the automatic and electronic transmission to the NEAFC Secretary of information obtained by the vessel monitoring system (VMS) concerning vessels flying their flag which fish or plan to fish in the Regulatory Area. The format and the specifications of these transmissions shall be determined in accordance with Article 50(2). Article 12 Communication of information 1. Member States shall communicate the reports and the information referred to in Articles 9 and 11 without delay to the NEAFC Secretary. In the event of technical malfunction, however, such reports and information shall be transmitted to the NEAFC Secretary within 24 hours of receipt. Member States shall ensure that all reports and messages forwarded by them are numbered sequentially. 2. Member States shall ensure that the reports and information transmitted to the NEAFC Secretary are in accordance with the data exchange formats and protocols determined in accordance with Article 50(2). Article 13 Transhipments and joint fishing operations 1. EU fishing vessels shall engage in transhipment activities in the Regulatory Area only if they have received prior authorisation from the competent authorities in their flag Member State. 2. EU fishing vessels may only engage in transhipment operations or joint fishing operations with vessels flying the flag of a Contracting Party and vessels of a non-Contracting Party granted the status of a cooperating non-Contracting Party by NEAFC. 3. EU fishing vessels engaged in transhipment operations which on-load quantities on board shall not engage in other fishing activities, including joint fishing operations, during the same trip, with the exception of fish-processing operations and landings. Article 14 Separate stowage 1. EU fishing vessels which carry on board frozen fishery resources caught in the Convention Area by more than one fishing vessel may stow the fish from each of those vessels in more than one part of the hold but shall keep it clearly separate from fish caught by other vessels, in particular by using plastic, plywood or netting. 2. All catches taken inside the Convention Area shall be stowed separately from all catches taken outside the area. Article 15 Labelling of frozen fish When frozen, all fish caught in the Convention Area shall be identified with a clearly legible label or stamp. The label or stamp shall be placed at the time of stowage on each box or block of frozen fish and shall indicate the species, the production date, the ICES sub-area and division where the catch was taken and the name of the vessel which caught the fish. CHAPTER III INSPECTIONS AT SEA Article 16 NEAFC inspectors 1. Member States whose fishing vessels are authorised to fish in the Regulatory Area shall assign inspectors to the Scheme to carry out surveillance and inspection (NEAFC inspectors). 2. Member States shall issue a special identity document to each NEAFC inspector. The form of this document shall be determined in accordance with Article 50(2). 3. Each NEAFC inspector shall carry and produce the special identity document when boarding a fishing vessel. Article 17 General provisions for inspection and surveillance 1. The Commission or the body designated by it shall coordinate the surveillance and inspection activities for the Union and shall draw up each year, in concert with the Member States concerned, a joint deployment plan for Union participation in the Scheme in the following year. This deployment plan shall, inter alia, determine the number of inspections to be carried out. Where at any time more than ten EU fishing vessels are engaged in fishing activities carried out in respect of regulated resources in the Regulatory Area, the Commission or the body designated by it shall ensure that an inspection vessel from a Member State is present during that time in the Regulatory Area or that an agreement has been concluded with another Contracting Party to ensure the presence of an inspection vessel. 2. Member States shall ensure that the inspections by their NEAFC inspectors are carried out in a non-discriminatory manner and in accordance with the Scheme. The number of inspections shall be based on fleet size, taking into account the time spent by fishing vessels in the Regulatory Area. 3. The Commission or the body designated by it shall seek to ensure, through an equitable distribution of inspections, equal treatment of all Contracting Parties with fishing vessels operating in the Regulatory Area. 4. Member States shall take steps to ensure that NEAFC inspectors from another Contracting Party are permitted to carry out inspections on board vessels flying their flag. 5. NEAFC inspectors shall avoid the use of force except in cases of legitimate self-defence. When carrying out inspections on board fishing vessels, NEAFC inspectors shall not carry fire-arms. This paragraph shall be without prejudice to national provisions concerning the prohibition of the use of force. 6. NEAFC inspectors shall avoid causing any inconvenience to the fishing vessel or interfering with its activities and the catch retained on board, except when and to the degree necessary to carry out their mandates. Article 18 Means to carry out inspection 1. Member States shall make available to their NEAFC inspectors adequate means to enable them to carry out their surveillance and inspection tasks. To that end they shall assign inspection vessels and aircraft to the Scheme. 2. The Commission or the body designated by it shall send to the NEAFC Secretary before 1 January each year details of the plan together with the names of the NEAFC inspectors and special inspection vessels as well as the types of aircraft and their identification details (registration number, name, radio call-sign) which Member States are assigning to the Scheme during that year. Where appropriate, this information shall be taken from the list of inspectors referred to in Article 79(1) of Regulation (EC) No 1224/2009. Member States shall send changes to this list to the Commission or the body designated by it which in turn shall forward them to the NEAFC Secretary and the other Member States 1 month before the changes are due to come into effect. 3. Any vessel assigned to the Scheme and carrying NEAFC inspectors, as well as the boarding craft deployed by that vessel, shall display the NEAFC inspection special signal to indicate that NEAFC inspectors on board may carry out inspection duties in accordance with the Scheme. Aircraft assigned to the Scheme shall have their international radio call-sign clearly displayed. The form of the special signal shall be determined in accordance with Article 50(2). 4. For each Union inspection vessel or aircraft assigned to the Scheme, the Commission or the body designated by it shall keep a record of the date and hour of the start and termination of their duties under the Scheme as set out in the form determined in accordance with Article 50(2). Article 19 Surveillance procedure 1. Surveillance shall be based on sightings of fishing vessels by NEAFC inspectors from a vessel or aircraft assigned to the Scheme. NEAFC inspectors shall forward a copy of each sighting report for every vessel without delay, by electronic transmission in the form set out in accordance with Article 50(2), to the flag state of the vessel concerned, to the Commission or the body designated by it and to the NEAFC Secretary. A hard copy of each sighting report and any photographs shall be forwarded on request to the flag state of the vessel concerned. 2. NEAFC inspectors shall record their sightings in a surveillance report using a form established in accordance with Article 50(2). Article 20 Inspection procedure 1. NEAFC inspectors shall not board any fishing vessel without prior notice being transmitted by radio to that vessel or without that vessel being given the appropriate signal using the International Code of Signals, including the identity of the inspection platform; however, it shall not be necessary for such notice to be acknowledged as received. 2. NEAFC inspectors shall have the authority to examine all relevant areas, decks and rooms of the fishing vessels, catch (whether processed or not), nets or other gear, equipment, and any relevant documents which they deem necessary to verify compliance with the conservation and management measures adopted by NEAFC and to question the master or a person designated by the master. 3. The fishing vessel to be boarded shall not be required to stop or manoeuvre when fishing, shooting or hauling. The NEAFC inspectors may order that the hauling of the fishing gear be interrupted or delayed until they have boarded the fishing vessel but may not do so in any event more than 30 minutes after the fishing vessel has received the signal referred to in paragraph 1. 4. Masters of inspection platforms shall ensure that they manoeuvre at a safe distance from the fishing vessels in accordance with good seamanship. 5. NEAFC inspectors may instruct a fishing vessel to delay its entry into or exit from the Regulatory Area for up to 6 hours from the time of transmission by the fishing vessel of the reports referred to in Article 9(1)(a) and (c). 6. The duration of an inspection shall not exceed 4 hours, or the time it takes to haul in the net and to inspect the net and the catch, whichever is longer. Where an infringement is detected the NEAFC inspectors may stay on board for the time necessary for the completion of the measures provided for in Article 29(1)(b). 7. In special circumstances relating to the size of a fishing vessel and the quantities of fish retained on board, the duration of the inspection may exceed the limits laid down in paragraph 6. In such a situation, NEAFC inspectors shall under no circumstances stay on board the fishing vessel longer than the time required to complete the inspection. The reasons for exceeding the limit laid down in paragraph 6 shall be recorded in the inspection report referred to in paragraph 9. 8. No more than two NEAFC inspectors assigned by a Member State shall board a fishing vessel of another Contracting Party. In carrying out their inspection, the NEAFC inspectors may request the master to provide any assistance which is required. NEAFC inspectors shall not interfere with the master’s ability to communicate with the authorities of the flag state during the boarding and inspection. 9. Each inspection shall be documented by the completion of an inspection report in the format established in accordance with Article 50(2). The master may add his comments to the inspection report which shall be signed by the NEAFC inspectors at the end of the inspection. A copy of the inspection report shall be given to the master of the fishing vessel. A copy of each inspection report shall be transmitted without delay to the flag state of the inspected vessel and to the Commission or the body designated by it. The Commission or the body designated by it shall forward the copy promptly to the NEAFC Secretary. The original or a certified copy of each inspection report shall be forwarded on request to the flag state of the inspected vessel. Article 21 Obligations of the master of the vessel during the inspection procedure The master of a fishing vessel shall: (a) facilitate prompt and safe boarding and disembarkation pursuant to specifications adopted in accordance with Article 50(2); (b) cooperate with and assist in the inspection of the fishing vessel conducted pursuant to this Regulation, not obstruct, intimidate or interfere with the NEAFC inspectors in the performance of their duties and ensure their safety; (c) allow the NEAFC inspectors to communicate with the authorities of the flag state and the inspecting state; (d) provide access to any areas, decks and rooms of the fishing vessel, catch (whether processed or not), nets or other gear, equipment, and to any relevant information or documents which the NEAFC inspectors deem necessary in accordance with Article 20(2); (e) provide copies of documents as required by the NEAFC inspectors; and (f) provide NEAFC inspectors with reasonable facilities, including, where appropriate, food and accommodation when they remain on board the vessel in accordance with Article 32(3). CHAPTER IV PORT STATE CONTROL OF FISHING VESSELS FLYING THE FLAG OF ANOTHER CONTRACTING PARTY Article 22 Scope Without prejudice to Regulation (EC) No 1224/2009 and to Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing (10), the provisions set out in this Chapter shall apply to landing or transhipping in ports of Member States of fishery resources frozen after being caught in the Convention Area by fishing vessels flying the flag of another Contracting Party. Article 23 Designated ports Member States shall designate and notify the Commission of ports where the landing or transhipment of fishery resources frozen after being caught in the Convention Area by fishing vessels flying the flag of another Contracting Party are permitted. The Commission shall notify the NEAFC Secretary of these ports and of any changes to the list of ports designated at least 15 days before the change comes into force. Landings and transhipments of fish frozen after being caught in the Convention Area by fishing vessels flying the flag of another Contracting Party shall be allowed only in designated ports. Article 24 Prior notification of entry into port 1. In accordance with Article 6 of Regulation (EC) No 1005/2008, when the master of a fishing vessel carrying fish referred to in Article 22 of this Regulation intends to call into a port to land or tranship fish, the master of the vessel, or his representative, shall notify the competent authorities of the Member State of the port he wishes to use no later than three working days before the estimated time of arrival. However, a Member State may make provision for another notification period, taking into account, in particular, the distance between the fishing grounds and its ports. In such a case, the Member State shall inform the Commission, or the body designated by it, and the NEAFC Secretary thereof without delay. 2. Masters or their representatives may cancel a prior notification by notifying the competent authorities of the port they wish to use no later than 24 hours before the notified estimated time of arrival in that port. The notification shall be accompanied by a copy of the original notification form with the word ‘CANCELLED’ written across it. However, a Member State may make provision for another notification period for cancellation. In such a case, the Member State shall inform the Commission, or the body designated by it, and the NEAFC Secretary thereof without delay. 3. The competent authorities of the port Member State shall forward without delay a copy of the notifications referred to in paragraphs 1 and 2 to the flag state of the fishing vessel and to the flag state or states of the donor vessels when the fishing vessel has engaged in transhipment operations. A copy of the notification referred to in paragraph 2 shall also be forwarded without delay to the NEAFC Secretary. 4. The format and the specifications of the notifications shall be determined in accordance with Article 50(2). As far as necessary, further detailed rules on the notification and cancellation procedures under this Article, including periods, shall be adopted in accordance with the procedure laid down in Articles 46 to 49. Article 25 Authorisation to land or tranship 1. The flag state of the fishing vessel intending to land or tranship or, where the fishing vessel has engaged in transhipment operations outside EU waters, the flag state or states of the donor vessels, shall, by returning a copy of the prior notification referred to in Article 24 to the competent authorities of the port Member State, confirm that: (a) the fishing vessel which declared having caught the fish had sufficient quota for the species declared; (b) the quantities of fish on board have been duly reported and taken into account for the calculation of any catch or effort limitations that may be applicable; (c) the fishing vessel which declared having caught the fish had authorisation to fish in the areas declared; (d) the presence of the fishing vessel in the area of catch declared has been verified according to VMS data. 2. Landing or transhipment operations may only start after authorisation has been given by the competent authorities of the port Member State. Such authorisation shall only be given if the confirmation from the flag state referred to in paragraph 1 has been received. 3. By way of derogation from paragraph 2, the competent authorities of the port Member State may authorise all or part of a landing in the absence of the confirmation referred to in paragraph 1, but in such cases they shall keep the fish concerned in storage under their control. The fish shall only be released to be sold, taken over or transported once the confirmation referred to in paragraph 1 has been received. If the confirmation has not been received within 14 days of the landing the competent authorities of the port Member State may confiscate and dispose of the fish in accordance with national rules. 4. The competent authorities of the port Member State shall without delay notify their decision on whether or not to authorise the landing or transhipment to the master and shall inform the NEAFC Secretary thereof. 5. Detailed rules on the authorisation to land or tranship under this Article shall be adopted in accordance with the procedure laid down in Articles 46 to 49. Article 26 Port inspections 1. Each Member State shall carry out inspections of at least 15 % of landings or transhipments in its ports during each reporting year. 2. Inspections shall involve the monitoring of the entire discharge or transhipment and include a cross-check between the quantities by species recorded in the prior notification of landing and the quantities by species landed or transhipped. When the landing or transhipment has been completed, the inspector shall verify and note the quantities by species of fish remaining on board. 3. National inspectors shall make all possible efforts to avoid delaying a vessel unduly and to ensure that the vessel suffers the minimum interference and inconvenience and that degradation of the quality of the fish is avoided. 4. The port Member State may invite inspectors of other Contracting Parties to accompany their own inspectors and observe the inspection of landings or transhipment operations of fishery resources caught by fishing vessels flying the flag of another Contracting Party. Article 27 Inspection reports 1. Each inspection shall be documented by the completion of an inspection report using the form established in accordance with Article 50(2). 2. The master may add his comments to the inspection report, which shall be signed by the inspector and the master at the end of the inspection. A copy of the inspection report shall be given to the master of the fishing vessel. 3. A copy of each inspection report shall be transmitted without delay to the flag state of the inspected fishing vessel, to the flag state or states of the donor vessels where the vessel has engaged in transhipment operations, to the Commission or the body designated by it and to the NEAFC Secretary. The original or a certified copy of each inspection report shall be forwarded on request to the flag state of the inspected vessel. CHAPTER V INFRINGEMENTS Article 28 Scope Without prejudice to Regulation (EC) No 1224/2009 and to Regulation (EC) No 1005/2008 the provisions set out in this Chapter shall apply to EU fishing vessels and to fishing vessels flying the flag of another Contracting Party used or intended for use for fishing activities carried out in respect of fishery resources in the Regulatory Area. Article 29 Infringement procedures 1. Where inspectors find that there are clear grounds for believing that a fishing vessel has engaged in any activity contrary to the conservation and management measures adopted by NEAFC they shall: (a) record the infringement in the report referred to in Articles 19(2), 20(9) or 27; (b) take all necessary measures to ensure security and continuity of the evidence. An identification mark may be affixed securely to any part of the fishing gear which appears to the inspector to be or to have been in contravention of applicable measures; (c) attempt immediately to communicate with an inspector or designated authority of the flag state of the inspected fishing vessel; (d) transmit the inspection report promptly to the Commission or the body designated by it. 2. The Member State carrying out the inspection shall communicate in writing the details of the infringement to the designated authority of the flag state of the inspected vessel and to the Commission or the body designated by it and, whenever possible, shall do so during the first working day following the start of the inspection. 3. The Member State carrying out the inspection shall send without delay the original of the surveillance or inspection report with any supporting documents to the competent authorities of the flag state of the inspected fishing vessel as well as a copy to the Commission or the body designated by it, which shall forward a copy to the NEAFC Secretary. Article 30 Follow-up in the case of infringement 1. Where a Member State is notified by another Contracting Party or another Member State of an infringement committed by a fishing vessel flying its flag, it shall take prompt action in conformity with its national law to obtain and consider the evidence of the infringement and to conduct any further investigation necessary for the follow-up to the infringement and, whenever possible, to inspect the fishing vessel concerned. 2. Member States shall designate the competent authorities which are to receive evidence of infringement and shall inform the Commission or the body designated by it of the address of those authorities and of any change in this information. The Commission or the body designated by it shall subsequently forward the information to the NEAFC Secretary. Article 31 Serious infringements For the purpose of this Regulation, the following infringements shall be considered to be serious: (a) fishing without a valid authorisation issued by the flag state; (b) fishing without quota or after its exhaustion; (c) use of prohibited fishing gear; (d) serious misrecording of catches; (e) repeated failure to comply with Articles 9 or 11; (f) landing or transhipping in a port not designated in accordance with Article 23; (g) failure to comply with Article 24; (h) landing or transhipment without authorisation of the port state as referred to in Article 25; (i) preventing an inspector from carrying out his duties; (j) directed fishing for a stock which is subject to a moratorium or for which fishing is prohibited; (k) falsifying or concealing the markings, identity or registration of a fishing vessel; (l) concealing, tampering with or disposing of evidence relating to an investigation; (m) multiple violations which together constitute a serious disregard of conservation and management measures; (n) engaging in transhipment or joint fishing operations with vessels of a non-Contracting Party which has not been accorded the status of a cooperating non-Contracting Party by NEAFC; (o) supplying any provisions, fuel or other services to vessels that have been placed on the list referred to in Article 44. Article 32 Follow-up in the case of serious infringements 1. If an inspector considers that there are clear grounds for believing that a fishing vessel has committed a serious infringement under Article 31, that inspector shall promptly notify that infringement to the Commission or the body designated by it, the competent authorities of the flag state of the inspected fishing vessel and the flag state or states of the donor vessels where the inspected vessel has engaged in transhipment operations, in accordance with Article 29(3), and shall also transmit a copy to the NEAFC Secretary. 2. In order to preserve the evidence, the inspector shall take all necessary measures to ensure the security and continuity thereof whilst minimising inconvenience to the vessel and interference with its operation. 3. The inspector shall be entitled to remain on board the fishing vessel for the period necessary to provide information on the infringement to the duly authorised inspector referred to in Article 33, or until receiving a reply from the flag state requesting him to leave the fishing vessel. Article 33 Follow-up in the case of serious infringements by an EU fishing vessel 1. Flag Member States shall respond to the notification referred to in Article 32(1) without delay and shall ensure that the fishing vessel concerned is inspected within 72 hours by an inspector duly authorised in relation to the infringement. The duly authorised inspector shall board the fishing vessel concerned and examine the evidence of the suspected infringement established by the inspector, and forward the results of the examination as quickly as possible to the competent authority in the flag Member State and to the Commission or the body designated by it. 2. Following notification of the results of the examination referred to in paragraph 1, flag Member States shall, if the evidence so warrants, require the fishing vessel to proceed immediately, and in any case within 24 hours, to a port designated by that flag Member State, for a thorough inspection under its authority. 3. The flag Member State may authorise the inspecting state to bring without delay the fishing vessel to a port designated by the flag Member State. 4. If the fishing vessel is not called to port, the flag Member State must provide due justification in a timely manner to the Commission or the body designated by it and to the inspecting state. The Commission or the body designated by it shall forward such justification to the NEAFC Secretary. 5. Where a fishing vessel is required to proceed to port for a thorough inspection pursuant to paragraphs 2 or 3, a NEAFC inspector from another Contracting Party may, subject to the consent of the flag Member State of the fishing vessel, board and remain on board the fishing vessel as it proceeds to port, and may be present during the inspection of the fishing vessel in port. 6. Flag Member States shall inform promptly the Commission or the body designated by it of the outcome of the thorough inspection and of the measures that they have adopted as a result of the infringement. 7. The detailed rules for the implementation of this Article shall be determined in accordance with Article 50(2). Article 34 Reporting and follow-up of infringements 1. By 15 February each year, Member States shall report to the Commission or the body designated by it on the status of the proceedings concerning infringements of the conservation and management measures adopted by NEAFC which were committed during the previous calendar year. The infringements shall continue to be listed in each subsequent report until the proceedings are concluded in accordance with the relevant provisions of national law. The Commission or the body designated by it shall forward the reports to the NEAFC Secretary before 1 March of the same year. 2. The report referred to in paragraph 1 shall indicate the current status of the proceedings and in particular whether the case is pending, under appeal or still under investigation. The report shall describe in specific terms any sanctions imposed, stating in particular the level of fines, the value of forfeited fish and/or gear and any written warnings given and, if no action has been taken, it shall state the reasons thereof. Article 35 Treatment of inspection reports Without prejudice to Article 77 of Regulation (EC) No 1224/2009, Member States shall collaborate with each other and with other Contracting Parties in order to facilitate judicial or other proceedings arising from a report submitted by an inspector under the Scheme, subject to the rules governing the admissibility of evidence in domestic judicial or other systems. Article 36 Reports on surveillance and inspection activities 1. Each Member State shall report to the Commission or the body designated by it by 15 February each year for the previous calendar year: (a) the number of inspections it has carried out under Articles 19, 20 and 26, specifying the number of inspections on the vessels of each Contracting Party and, where an infringement has been committed, the date and position of the inspection of the individual vessel concerned and the nature of the infringement; (b) the number of hours flown and the number of days at sea on NEAFC patrols, the number of sightings of both Contracting Party vessels and non-Contracting Party vessels, and the list of individual vessels for which a surveillance report has been completed. 2. The Commission or the body designated by it shall compile a Union report on the basis of the reports of the Member States. It shall send the Union report to the NEAFC Secretary by 1 March each year. CHAPTER VI MEASURES TO PROMOTE COMPLIANCE BY NON-CONTRACTING PARTY FISHING VESSELS Article 37 Scope 1. This Chapter shall apply to non-Contracting Parties’ fishing vessels used or intended for use for fishing activities carried out in respect of fishery resources in the Convention Area. 2. This Chapter shall be without prejudice to Regulation (EC) No 1224/2009 and to Regulation (EC) No 1005/2008. Article 38 Sightings and identifications of non-Contracting Party vessels 1. Member States shall transmit without delay to the Commission or the body designated by it any information regarding non-Contracting Party vessels sighted or otherwise identified as engaging in fishing activities in the Convention Area. The Commission or the body designated by it shall inform promptly the NEAFC Secretary and all other Member States of each sighting report it receives. 2. The Member State which sighted the non-Contracting Party vessel shall attempt to inform that vessel without delay that it has been sighted or otherwise identified as engaging in fishing activities in the Convention Area and is consequently presumed, unless its flag state has been accorded the status of cooperating non-Contracting Party by NEAFC, to be undermining the NEAFC conservation and management measures. 3. In the case of a non-Contracting Party vessel sighted or otherwise identified as engaging in transhipment activities, the presumption of undermining the NEAFC conservation and management measures shall apply to any other non-Contracting Party vessel that has been identified as having engaged in such activities with that vessel. Article 39 Inspections at sea 1. NEAFC inspectors shall request permission to board and inspect non-Contracting Party vessels sighted or otherwise identified by a Contracting Party as engaging in fishing activities in the Convention Area. If the master consents to the boarding and inspection of the vessel, the inspection shall be documented by the completion of an inspection report, as referred to Article 20(9). 2. NEAFC inspectors shall without delay transmit a copy of the inspection report to the Commission or the body designated by it, to the NEAFC Secretary and to the master of the non-Contracting Party vessel. Where the evidence in that report so warrants, a Member State may take such action as may be appropriate in accordance with international law. Member States are encouraged to examine whether their national measures are appropriate for the exercise of jurisdiction over such vessels. 3. If the master does not consent to the boarding and inspection of his vessel or does not fulfil any one of the obligations laid down in Article 21(a) to (d), the vessel shall be presumed to have engaged in illegal, unreported and unregulated fishing activities (IUU activities). The NEAFC Inspector shall inform without delay the Commission or the body designated by it thereof. In turn the Commission or the body designated by it shall promptly inform the NEAFC Secretary thereof. Article 40 Entry into port 1. The master of a non-Contracting Party fishing vessel may only call into a port designated in accordance with Article 23. The master intending to call into a port of a Member State shall notify the competent authorities of the port Member State in accordance with the provisions of Article 24. The port Member State concerned shall forward this information without delay to the flag state of the vessel and to the Commission or the body designated by it. In turn, the Commission or the body designated by it shall forward this information to the NEAFC Secretary. 2. The port Member State shall prohibit the entry into its ports of vessels that have not given the required prior notification of entry into port as referred to in Article 24. Article 41 Inspections in port 1. Member States shall ensure that all non-Contracting Party vessels entering one of their ports are inspected. The vessel shall not be allowed to land or tranship any fish until this inspection has been completed. Each inspection shall be documented by the completion of an inspection report as provided for in Article 27. Where the master of the vessel has failed to fulfil any one of the obligations laid down in Article 21(a) to (d), the vessel shall be presumed to have engaged in IUU activities. 2. Information on the results of all inspections of non-Contracting Party vessels conducted in the ports of Member States, and concerning subsequent action, shall immediately be transmitted to the Commission or the body designated by it, which shall forward such information to the NEAFC Secretary. Article 42 Landings and transhipments 1. Landings and transhipments may only start after authorisation has been given by the competent authorities of the port state. 2. Landings and transhipments from a non-Contracting Party vessel which has been inspected pursuant to Article 41 shall be prohibited in the ports and waters of all Member States if such an inspection reveals that the vessel has species on board which are subject to recommendations established under the Convention, unless the master of the vessel provides satisfactory evidence to the competent authorities proving that the fish were caught outside the Regulatory Area or in compliance with all relevant recommendations established under the Convention. 3. The vessel shall not be authorised to engage in landings or transhipments if the flag state of the vessel, or the flag state or states of the donor vessels, where the vessel has engaged in transhipment operations, does not provide the confirmation referred to in Article 25. 4. Furthermore, landings and transhipments shall be prohibited where the master of the vessel has failed to fulfil any one of the obligations laid down in Article 21(a) to (d). Article 43 Reports on non-Contracting Parties activities 1. Each Member State shall report to the Commission or the body designated by it by 15 February each year for the previous calendar year: (a) the number of inspections of non-Contracting Party vessels that it conducted under this Scheme at sea or in its ports, the names of the vessels inspected and their respective flag states, the dates of the inspections and the names of any ports where the inspections were conducted, and the results of such inspections; and (b) where fish are landed or transhipped following an inspection pursuant to this Scheme, the evidence provided pursuant to Article 42. 2. In addition to surveillance reports and information on inspections, Member States may at any time submit to the Commission or the body designated by it any further information which might be relevant for the identification of non-Contracting Party vessels that might be carrying out IUU activities in the Convention Area. 3. On the basis of this information, the Commission or the body designated by it shall send a global report on non-Contracting Parties’ activities to the NEAFC Secretary by 1 March each year. Article 44 Vessels engaged in IUU activities 1. Member States shall ensure that vessels appearing in the provisional list of vessels engaged in IUU activities established by NEAFC (‘A’ list) are: (a) inspected in accordance with the provisions of Article 41 when they enter their ports; (b) not authorised to land or tranship in their ports or in the waters under their jurisdiction; (c) not given assistance by fishing vessels, support vessels, refuel vessels, the mother-ship and cargo vessels flying their flag or permitted to participate in any transhipment or joint fishing operation with such vessels; (d) not supplied with provisions, fuel or other services. 2. The provisions laid down in paragraph 1(b) and (d) shall not be applied to any vessel appearing on the ‘A’ list where a recommendation has been made to NEAFC that the vessel in question should be removed from the ‘A’ list. CHAPTER VII FINAL PROVISIONS Article 45 Confidentiality 1. In addition to the obligations laid down in Articles 112 and 113 of Regulation (EC) No 1224/2009, Member States shall ensure confidential treatment of electronic reports and messages transmitted to and received from the NEAFC Secretary pursuant to Articles 11, 12 and 19(1). 2. The detailed rules for the implementation of this Article shall be determined in accordance with Article 50(2). Article 46 Delegation of powers 1. The Commission may adopt, by means of delegated acts in accordance with Article 47 and subject to the conditions of Articles 48 and 49 the detailed rules for the application of Article 25, as well as the list of fishery resources referred to in Article 10(1) and detailed rules on the notification and cancellation procedures, including periods, as referred to in the second subparagraph of Article 24(4). 2. When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation. Article 47 Exercise of the delegation 1. The power to adopt delegated acts referred to in Article 46 shall be conferred on the Commission for a period of 3 years from 1 January 2011. The Commission shall make a report in respect of the delegated powers at the latest 6 months before the end of the three-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 48. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 48 and 49. Article 48 Revocation of the delegation 1. The delegation of power referred to in Article 46 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 49 Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by 2 months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act. Article 50 Implementation 1. The Commission shall be assisted by a Management Committee for Fisheries and Aquaculture. 2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply. The period referred to in Article 4(3) of Decision 1999/468/EC shall be set at 3 months. Article 51 Procedure for amendments As far as is necessary, in order to incorporate into Union law amendments to the existing provisions of the Scheme which become obligatory for the Union, the Commission may amend the provisions of this Regulation by means of delegated acts in accordance with Article 47 and subject to the conditions set out in Articles 48 and 49, concerning: (a) participation of Contracting Parties in the fishery in the Regulatory area as referred to in Article 5; (b) removal and disposal of fixed gear and the retrieval of lost gear as referred to in Articles 6 and 7; (c) use of VMS as referred to in Article 11; (d) cooperation and communication of information to the NEAFC Secretary as referred to in Article 12; (e) requirements for separate stowage and labelling of frozen fishery resources as referred to in Articles 14 and 15; (f) assignment of NEAFC inspectors as referred to in Article 16; (g) measures to promote compliance with the Scheme by non-Contracting Party fishing vessels under Chapter VI; (h) the list of regulated resources set out in the Annex. When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation. Article 52 Repeal Regulation (EC) No 2791/1999 is hereby repealed. Article 53 Entry into force This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 15 December 2010. For the European Parliament The President J. BUZEK For the Council The President O. CHASTEL (1) Opinion of 17 March 2010 (not yet published in the Official Journal). (2) Position of the European Parliament of 19 October 2010 (not yet published in the Official Journal) and decision of the Council of 29 November 2010. (3) OJ L 227, 12.8.1981, p. 21. (4) OJ L 22, 26.1.2009, p. 1. (5) OJ L 343, 22.12.2009, p. 1. (6) OJ L 184, 17.7.1999, p. 23. (7) OJ L 337, 30.12.1999, p. 1. (8) OJ L 56, 2.3.2005, p. 8. (9) OJ L 261, 20.10.1993, p. 1. (10) OJ L 286, 29.10.2008, p. 1. ANNEX REGULATED RESOURCES A) Pelagic and oceanic species Stock (common name) FAO code Scientific Name ICES subareas and divisions Redfish REB Sebastes mentella I, II, V, XII, XIV Norwegian Spring Spawning Herring (Atlanto Scandian) HER Clupea harengus I, II Blue whiting WHB Micromesistius poutassou IIa, IVa, Vb, VI, VII, XII, XIV Mackerel MAC Scomber scombrus IIa, IV, V, VI, VII, XII Haddock HAD Melanogrammus aeglefinus VIb B) Deep-Sea Species Stock (common name) FAO code Scientific Name ICES subareas Baird’s smoothhead ALC Alepocehalus bairdii I to XIV Risso’s smoothhead PHO Alepocephalus rostratus I to XIV Blue antimora (Blue hake) ANT Antimora rostrata I to XIV Black scabbardfish BSF Aphanopus carbo I to XIV Iceland catshark API Apristurus spp. I to XIV Greater silver smelt ARG Argentina silus I to XIV Alfonsinos ALF Beryx spp. I to XIV Tusk USK Brosme brosme I to XIV Gulper shark GUP Centrophorus granulosus I to XIV Leafscale gulper shark GUQ Centrophorus squamosus I to XIV Black dogfish CFB Centroscyllium fabricii I to XIV Portuguese dogfish CYO Centroscymnus coelolepis I to XIV Longnose velvet dogfish CYP Centroscymnus crepidater I to XIV Deep-water red crab KEF Chaceon (Geryon) affinis I to XIV Rabbit fish (Rattail) CMO Chimaera monstrosa I to XIV Frilled shark HXC Chlamydoselachus anguineus I to XIV Conger eel COE Conger conger I to XIV Roundnose grenadier RNG Coryphaenoides rupestris I to XIV Kitefin shark SCK Dalatias licha I to XIV Birdbeak dogfish DCA Deania calceus I to XIV Black (Deep-water) cardinal fish EPI Epigonus telescopus I to XIV Greater lanternshark SHL Etmopterus princeps I to XIV Velvet belly SHL Etmopterus spinax I to XIV Blackmouth dogfish SHO Galeus melastomus I to XIV Mouse catshark GAM Galeus murinus I to XIV Bluemouth (Blue mouth redfish) BRF Helicolenus dactylopterus I to XIV Bluntnose six-gilled shark SBL Hexanchus griseus I to XIV Orange roughy ORY Hoplostethus atlanticus I to XIV Silver roughy (Pink) HPR Hoplostethus mediterraneus I to XIV Large-eyed rabbit fish (Ratfish) CYH Hydrolagus mirabilis I to XIV Silver scabbard fish (Cutlass fish) SFS Lepidopus caudatus I to XIV Eelpout ELP Lycodes esmarkii I to XIV Roughhead grenadier (Rough rattail) RHG Macrourus berglax I to XIV Blue ling BLI Molva dypterygia I to XIV Ling LIN Molva molva I to XIV Common mora RIB Mora moro I to XIV Sailfin roughshark (Sharpback shark) OXN Oxynotus paradoxus I to XIV Red (blackspot) seabream SBR Pagellus bogaraveo I to XIV Forkbeards GFB Phycis spp. I to XIV Wreckfish WRF Polyprion americanus I to XIV Round skate RJY Raja fyllae I to XIV Arctic skate RJG Raja hyperborea I to XIV Norwegian skate JAD Raja nidarosiensis I to XIV Greenland halibut GHL Rheinhardtius hippoglossoides I to XIV Straightnose rabbitfish RCT Rhinochimaera atlantica I to XIV Knifetooth dogfish SYR Scymnodon ringens I to XIV Small redfish (Norway haddock) SFV Sebastes viviparus I to XIV Greenland shark GSK Somniosus microcephalus I to XIV Spiny (Deep-sea) Scorpionfish TJX Trachyscorpia cristulata I to XIV Appendix Statements on Article 51 ‘The European Parliament, the Council and the Commission note that any of the provisions of a non-essential character of the basic legislative act, which now are listed under Article 51 of the Regulation (delegation of powers), can become at any time in the future a significant element of the existing NEAFC control scheme from a political point of view, in which case the European Parliament, the Council and the Commission recall that either of the legislators, the Council or the European Parliament, can immediately exercise either the right to object to a draft Commission delegated act or the right to revoke the delegated powers as provided under Article 48 and Article 49 of the Regulation respectively.’ ‘The Council and the Parliament agree that the inclusion of any provision of the NEAFC control scheme into this Regulation as a non-essential element, now listed under Article 51, does not imply per se that such provisions will automatically be considered by the legislators to be of a non-essential character in any future Regulations.’ ‘The European Parliament, the Council and the Commission declare that the provisions of this Regulation shall be without prejudice to any future position of the institutions as regards the implementation of Article 290 TFEU or individual legislative acts containing such provisions.’

Future international cooperation in north-east Atlantic fisheries Future international cooperation in north-east Atlantic fisheries SUMMARY OF: Regulation (EU) No 1236/2010 control and enforcement system for the north-east Atlantic fisheries area Convention on cooperation in north-east Atlantic fisheries WHAT IS THE AIM OF THE REGULATION? It aims to promote international cooperation on the conservation, control and good management of the fisheries in the north-east Atlantic area. It enacts the Convention on Multilateral Cooperation in North-East Atlantic Fisheries which sets out rules for cooperation on the conservation and management of fisheries. In particular, the regulation implements the NEAFC Scheme of Control and Enforcement, which provides for control and enforcement measures for vessels flying the flag of its contracting parties; arrangements for inspections at sea; surveillance; and infringement procedures. KEY POINTS The scheme creates a new port state control system which will effectively close European ports to landings and transhipments* of frozen fish which have not been verified to be legal. EU countries must: designate a competent authority which acts as the contact point to receive surveillance and inspection reports, available 24 hours a day; send the European Commission a list of all vessels flying their flag registered in the EU that are authorised to fish in the area covered by the regulation; undertake to retrieve on a regular basis lost fishing gear belonging to vessels flying their flag. Vessel masters must: log each entry and exit from the regulatory area*, the estimated cumulative catch, the amount of fish discarded, and the fishing depth; send catch reports to their Fisheries Monitoring Centre*, which can then be accessed by the Commission. Masters of vessels which process and/or freeze their catch must record the species and type of product and stow fish products in the hold in a way that allows each species to be identified from a stowage plan kept on board. When frozen, all fish must be identified with a clearly legible label or stamp. When more than 10 EU fishing vessels are engaged in fishing activities* carried out in the regulatory area, an inspection vessel will be present. Each EU country must inspect at least 5% of landings or transhipments of fresh fish and at least 7.5% of frozen fish in its ports during each reporting year. When inspectors find that a fishing vessel has engaged in activity contrary to NEAFC conservation and management measures, they shall record and report the infringement. Serious infringements include: fishing without authorisation; fishing without quota; using prohibited fishing gear; misrecording catches; falsifying the marking or identity of vessels; preventing an inspector from carrying out their duties. EU countries’ inspectors must also report any unauthorised vessels they record to the Commission. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2011. BACKGROUND The north-east Atlantic is one of the most abundant fishing areas in the world. The Convention on Multilateral Cooperation in North East Atlantic Fisheries entered into force in November 1982. The contracting parties to the Convention are the EU, the Faroe Islands, Greenland, Iceland, Norway and the Russian Federation, and the area covered stretches from the southern tip of Greenland, east to the Barents Sea and south to Portugal. In 2006, the North-East Atlantic Fisheries Commission (NEAFC) adopted a recommendation establishing a scheme of control and enforcement on fishing vessels operating in the area covered by the Convention. It also included rules for vessels flying the flag of a non-contracting party to ensure full respect of conservation and management measures adopted by the NEAFC. The NEAFC has recommended removing a number of vessels that have been engaged in illegal, unreported and unregulated fisheries. Similar rules are in force in EU waters under the common fisheries policy. KEY TERMS Transhipment: the transfer of a catch from one fishing boat to another which then incorporates it into a larger batch for shipment. Regulatory area: the waters covered by the convention which lie beyond the jurisdiction of the contracting parties. See map. Fisheries Monitoring Centre: an operational centre based in an EU country which can receive, process and transmit fisheries data. Fishing activities: fishing, fish processing operations, the transhipment or landing of fish or fish products, and any other commercial activity in preparation for or related to fishing, including packaging, transporting, refuelling or resupplying. MAIN DOCUMENTS Regulation (EU) No 1236/2010 of the European Parliament and of the Council of 15 December 2010 laying down a scheme of control and enforcement applicable in the area covered by the Convention on future multilateral cooperation in the North-East Atlantic fisheries and repealing Council Regulation (EC) No 2791/1999 (OJ L 348, 31.12.2010, pp. 17-33) Successive amendments to Regulation (EU) No 1236/2010 have been incorporated into the original document. This consolidated version is of documentary value only. Convention on future multilateral cooperation in North- East Atlantic fisheries (OJ L 227, 12.8.1981, pp. 22-35) RELATED DOCUMENTS Council Regulation (EU) No 2018/120 of 23 January 2018 fixing for 2018 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, and amending Regulation (EU) 2017/127 (OJ L 27, 31.1.2018, pp. 1-168) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on External Dimension of the Common Fisheries Policy (COM(2011) 424 final, 13.7.2011) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, pp. 1-50) See consolidated version. Council Decision 81/608/EEC of 13 July 1981 concerning the conclusion of the Convention on Future Multilateral Cooperation in the North-East Atlantic Fisheries (OJ L 227, 12.8.1981, p. 21) last update 13.03.2018

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26.3.2021 EN Official Journal of the European Union L 107/1 REGULATION (EU) 2021/522 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(5) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) According to Article 3(1) of the Treaty on European Union (TEU), among the aims of the Union is the promotion of the well-being of its peoples. (2) According to Articles 9 and 168 of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union, a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities. (3) Article 168 TFEU provides that the Union is to complement and support national health policies, encourage cooperation between Member States and promote the coordination between their programmes, in full respect of the responsibilities of Member States for the definition of their health policies and for the organisation, management and delivery of health services and medical care. (4) Actions have been taken in particular under the previous programmes of Union action in the field of public health, namely those provided for by Decisions No 1786/2002/EC (4) and No 1350/2007/EC (5) of the European Parliament and of the Council and by Regulation (EU) No 282/2014 of the European Parliament and of the Council (6), to meet the requirements set out in Article 168 TFEU. (5) On 11 March 2020, the World Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a global pandemic. That pandemic has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering, which particularly affect people with chronic conditions. In addition, staff in health care settings, who have been essential during the COVID-19 crisis, have been exposed to great health risks. (6) While Member States are responsible for their health policies, they should protect public health in a spirit of European solidarity, as called for in the communication of the Commission of 13 March 2020 on coordinated economic response to the COVID-19 outbreak. Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for further action at Union level to support cooperation and coordination among the Member States. That cooperation should improve preparedness for, and the prevention and control of, the spread of severe human infections and diseases across borders in order to combat other serious cross-border threats to health and to safeguard and improve the health and well-being of all people in the Union. Preparedness is the key to improving resilience to future threats. In that regard, Member States should be given the possibility of carrying out stress tests on a voluntary basis to improve preparedness and increase resilience. (7) It is therefore appropriate to establish a new and reinforced programme for Union action in the field of health, called the ‘EU4Health Programme’ (the ‘Programme’), for the period 2021-2027. In line with the goals of the Union’s action and the Union’s competences in the area of public health, the Programme should emphasise actions in relation to which there are advantages and efficiency gains from collaboration and cooperation at Union level, and actions that have an impact on the internal market. (8) The Programme should be a means of promoting actions in areas where there is a Union added value that can be demonstrated. Such actions should include, inter alia, strengthening the exchange of best practices between Member States, supporting networks for the sharing of knowledge or for mutual learning, addressing cross-border threats to health so as to reduce the risks of such threats and to mitigate their consequences, addressing certain issues relating to the internal market in relation to which the Union can achieve Union-wide high-quality solutions, thereby unlocking the potential of innovation in health, and improving efficiency by avoiding the duplication of activities and optimising the use of financial resources. The Programme should also support capacity-building actions to strengthen strategic planning, access to multisource financing and the capacity to invest in and implement actions of the Programme. In that respect, the Programme should provide country-specific tailor-made assistance to the Member States, or groups of Member States, with the greatest needs. (9) This Regulation lays down a financial envelope for the Programme which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (7), for the European Parliament and the Council during the annual budgetary procedure. This financial envelope comprises an amount of EUR 500 000 000 in 2018 prices in line with the joint declaration by the European Parliament, Council and Commission on the reinforcement of specific programmes and adaptation of basic acts of 22 December 2020 (8). (10) In order for the Programme to be balanced and focused, minimum and maximum shares of the overall budget should be laid down in this Regulation, for certain areas of action, with a view to providing guidance for the allocation of resources in relation to the implementation of the Programme. (11) Due to the serious nature of cross-border threats to health, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthening the capability in the Union to prepare for, respond to and manage any future health crises, the Programme should provide support to actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council (9) and other relevant mechanisms and structures referred to in the communication of the Commission of 11 November 2020 entitled ‘Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats’, including actions directed at strengthening preparedness planning and response capacity at national and Union level, at reinforcing the role of the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), and at establishing a health emergency preparedness and response authority. Such actions could include building capacity for responding to health crises, preventive measures related to vaccination and immunisation, strengthened surveillance programmes, provision of health information, and platforms to share best practices. In this context, the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness and surveillance, and the management capacity and response capacity of actors at Union and Member State levels, including contingency planning and preparedness exercises, in keeping with the ‘One Health’ and ‘Health in All Policies’ approaches. The Programme should facilitate the setting up of an integrated cross-cutting risk communication framework for all phases of a health crisis, namely prevention, preparedness and response. (12) With a view to strengthening capabilities in the Union to prevent, prepare for, respond to and manage health crises, the Programme should provide support to actions taken in the framework of the mechanisms and structures established under relevant Union legislation. That support could include capacity building in health crisis response, including contingency planning and preparedness, preventive measures such as those related to vaccination and immunisation, strengthened surveillance programmes and improved coordination and cooperation. (13) In the context of public health crises, clinical trials and health technology assessment (HTA) can contribute to speeding up the development and identification of effective medical countermeasures. It should therefore be possible for the Programme to provide support to facilitate actions in those fields. (14) With a view to protecting people in vulnerable situations, including those suffering from mental illness and those living with or most affected by communicable or non-communicable diseases and chronic diseases, the Programme should also promote actions which address and prevent the collateral impact of health crises on people belonging to such vulnerable groups and actions which improve mental health. (15) The COVID-19 crisis has highlighted many challenges, including the dependence of the Union on third countries in ensuring the supply of raw materials, active pharmaceutical ingredients, medicinal products, medical devices and personal protective equipment needed in the Union during health crises, in particular pandemics. The Programme should therefore provide support to actions that foster the production, procurement and management of crisis-relevant products within the Union to mitigate the risk of shortages, while ensuring complementarity with other Union instruments. (16) In order to minimise the public health consequences of serious cross-border threats to health, it should be possible for actions supported under the Programme to improve the interoperability of Member States’ health systems through cooperation and the exchange of best practices and also by increasing the number of joint actions. Those actions should ensure that Member States are able to respond to health emergencies, including by undertaking contingency planning, preparedness exercises and the upskilling of the healthcare and public health workforce as well as the establishment, in accordance with national strategies, of mechanisms for the efficient monitoring and needs-driven distribution or allocation of goods and services needed in times of crisis. (17) The provision of information to individuals plays an important role in preventing and responding to diseases. The Programme should therefore support communication activities addressed to the general public or to specific groups of people or professionals, in order to promote disease prevention and healthy lifestyles, to counter misinformation and disinformation as regards the prevention, cause and treatment of diseases, to address vaccine hesitancy and to support efforts to strengthen altruistic behaviour, such as organ and blood donations, in a manner that complements national campaigns on those matters. (18) In synergy with other Union programmes, such as the Digital Europe programme established by a Regulation of the European Parliament and of the Council establishing the Digital Europe programme and repealing Decision (EU) 2015/2240, Horizon Europe - the Framework Programme for Research and Innovation established by a Regulation of the European Parliament and of the Council establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (‘Horizon Europe’), the European Regional Development Fund (‘ERDF’) established by a Regulation of the European Parliament and of the Council on the European Regional Development Fund and on the Cohesion Fund, the European Social Fund Plus (ESF+) established by a Regulation of the European Parliament and of the Council on the European Social Fund Plus (ESF+), the InvestEU Programme established by Regulation (EU) 2021/523 of the European Parliament and of the Council (10), and the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council (11), actions that advance the digital transformation of health services and increase the interoperability of such services, including the development of a European health data space, could be supported under the Programme. (19) Health is an investment, and the Programme should have this concept at its core. Keeping people healthy and active longer and empowering them to take an active role in managing their health by improving their health literacy will have positive effects on health, health inequalities and inequities, access to sexual and reproductive healthcare, quality of life, workers’ health, productivity, competitiveness and inclusiveness, while reducing pressures on national healthcare systems and national budgets. The Programme should also support actions to reduce inequalities in the provision of healthcare, in particular in rural and remote areas, including in the outermost regions, for the purposes of achieving inclusive growth. The Commission has committed to helping Member States to reach the sustainable development targets set in the UN resolution of 25 September 2015 entitled ‘Transforming our world: the 2030 Agenda for Sustainable Development’(the ‘UN 2030 Agenda’), in particular Sustainable Development Goal 3 ‘Ensure healthy lives and promote well-being for all at all ages’. The Programme should therefore contribute to the actions towards reaching those targets. (20) Non-communicable diseases are often the result of a combination of genetic, physiological, environmental and behavioural factors. Non-communicable diseases such as cardiovascular disease, cancer, mental illness, neurological disorders, chronic respiratory disease and diabetes represent major causes of disability, ill-health, health-related retirement, and premature death in the Union, and cause a considerable social and economic impact. To decrease the impact of non-communicable diseases on individuals and society in the Union and to reach Goal 3 of the UN 2030 Agenda Sustainable Development Goals, in particular but not exclusively Target 3.4 of that Goal, namely to reduce premature mortality from non-communicable diseases by one third by 2030, it is essential to provide an integrated response that focuses on health promotion and disease prevention across relevant sectors. (21) The Programme therefore should support health promotion and disease prevention and improve mental health throughout the lifetime of an individual by addressing health risk factors, and health determinants, which would also contribute to the attainment of Goal 3 of the UN 2030 Agenda Sustainable Development Goals. The Programme should also therefore contribute to the objectives set out in the Commission communication of 11 December 2019 entitled ‘The European Green Deal’ (the ‘European Green Deal’). (22) The Programme should continue to support actions in the area of reducing and preventing alcohol-related harm, with particular emphasis on protecting the young. (23) The burden of chronic diseases is significant in the Union. It is well acknowledged that prevention and early detection are important in that regard. The Programme should support actions in those areas and should support the development of specific Union preventive and disease management guidelines and therefore aim to reduce the burden of Member States by working together to achieve better and more effective management of chronic diseases. Demographic changes, in particular the ageing of society, challenge the sustainability of health systems. Age-related diseases and disorders, such as dementia, and age-related disabilities, necessitate specific attention. (24) Cancer is the second leading cause of mortality in the Member States after cardiovascular disease. It is also one of the non-communicable diseases that share common risk factors and the prevention and control of which would benefit the majority of citizens. Poor nutrition, physical inactivity, obesity, tobacco use and harmful use of alcohol are risk factors common to other chronic diseases, such as cardiovascular disease, and therefore cancer prevention programmes should be implemented within the context of an integrated approach to preventing chronic diseases. Relevant measures in the ‘Europe’s Beating Cancer Plan’ set out in the communication of the Commission of 3 February 2021 should benefit from the Programme and from Horizon Europe’s mission on cancer, and should contribute to fostering an integrated approach that covers prevention, screening, early diagnosis, monitoring, treatment and care, as well as improving the quality of life of patients and survivors. (25) It should be possible to support studies on the influence of gender on the characteristics of diseases in order to contribute to improving knowledge and education in that area, thereby improving prevention, diagnosis, monitoring and treatment. (26) The Programme should work in synergy with and in a manner that complements other Union policies, programmes and funds, such as the Digital Europe Programme, Horizon Europe, the rescEU reserve under the Union Civil Protection Mechanism established by Decision (EU) 2019/420 of the European Parliament and of the Council (12) (the ‘rescEU reserve’), the Emergency Support Instrument established by Council Regulation (EU) 2016/369 (13), the ESF+, of which the Employment and Social Innovation strand forms part, including as regards synergies in relation to better protecting the health and safety of millions of workers in the Union, the InvestEU Programme, the Single Market Programme established by a Regulation of the European Parliament and of the Council establishing a programme for the internal market, competitiveness of enterprises, including small and medium-sized enterprises, the area of plants, animals, food and feed, and European statistics (Single Market Programme) and repealing Regulations (EU) No 99/2013, (EU) No 1287/2013, (EU) No 254/2014 and (EU) No 652/2014, the ERDF, the Recovery and Resilience Facility, Erasmus+ established by a Regulation of the European Parliament and of the Council establishing Erasmus+: the Union Programme for education and training, youth and sport and repealing Regulation (EU) No 1288/2013, the European Solidarity Corps Programme established by a Regulation of the European Parliament and of the Council establishing the European Solidarity Corps Programme and repealing Regulations (EU) 2018/1475 and (EU) No 375/2014, and external action instruments of the Union, such as the Neighbourhood, Development and International Cooperation Instrument established by a Regulation of the European Parliament and of the Council establishing the Neighbourhood, Development and International Cooperation Instrument – Global Europe, amending and repealing Decision No 466/2014/EU of the European Parliament and of the Council and repealing Regulation (EU) 2017/1601 of the European Parliament and of the Council and Council Regulation (EC, Euratom) No 480/2009, and the Instrument for Pre-accession Assistance III established by a Regulation of the European Parliament and of the Council establishing the Instrument for Pre-accession Assistance (IPA III). Where appropriate, common rules should be established with a view to ensuring that there is consistency and complementarity between Union policies, programmes and funds, while ensuring that the specificities of those policies are respected, and with a view to aligning with the strategic requirements of those policies, programmes and funds, such as the enabling conditions under the ERDF and ESF+. The Commission and the Member States should ensure that such synergies and complementarities are duly taken into consideration when drafting the annual work programmes as provided for in this Regulation. (27) The Commission should consult the Member States through a ‘EU4Health Steering Group’ to be established by this Regulation on the priorities and strategic orientations of the Programme, in order to ensure that there is consistency and complementarity between the Programme and other policies, instruments and actions of the Union, as well as on the implementation of the Programme. (28) The Programme should contribute to the establishment of a reserve of essential crisis-relevant products, in synergy and complementarity with the rescEU reserve, with the emergency support established under Regulation (EU) 2016/369, with the Recovery and Resilience Facility and with other Union policies, programmes and funds, complementing national stockpiles at Union level where needed. (29) Given rising healthcare demand, Member States’ healthcare systems face challenges regarding the availability and affordability of medicinal products. To ensure that there is better public health protection, as well as that patients in the Union are safe and empowered, it is essential that patients and health systems have access to sustainable, efficient, equitable, affordable and high-quality medicinal products, including in the cross-border context, and that they can fully benefit from those medicinal products on the basis of transparent, consistent, and patient-oriented medical information. (30) Given rising healthcare demand, inter alia, the Programme should support the development of a Union system for the monitoring, reporting and notification of shortages of medicinal products and medical devices in order to avoid fragmentation of the internal market and to ensure greater availability and affordability of those medicinal products and medical devices while limiting the extent to which their supply chains depend on third countries. The Programme should therefore encourage the production of medicinal products and medical devices within the Union. In particular, in order to address unmet medical needs, the Programme should provide support to the generation of clinical and real-world evidence to enable the development of, authorisation of, evaluation of and access to effective medicinal products, including generics and biosimilars, to medical devices and to treatment, should promote research and development with respect to new medicinal products, with particular attention to be given to antimicrobials and vaccines to tackle antimicrobial resistance and vaccine-preventable diseases, respectively, should promote incentives to boost the production capacity for antimicrobials, personalised treatment and vaccination, and should foster the digital transformation of healthcare products and platforms for monitoring and collecting information on medicinal products. The Programme should also strengthen decision-making regarding medicinal products by enabling access to and the analysis of real-world healthcare data. The Programme should also help to ensure that the best use is made of research results and facilitate the uptake, scaling-up and deployment of health innovations in healthcare systems and clinical practice. (31) As the optimal delivery and use of medicinal products, and of antimicrobials in particular, yield benefits for individuals and health systems, the Programme should promote their prudent and efficient use in accordance with the One Health approach, with the ‘European One Health Action Plan against Antimicrobial Resistance (AMR)’ set out in the communication of the Commission of 29 June 2017, and with the ‘European Union Strategic Approach to Pharmaceuticals in the Environment’ set out in the communication of the Commission of 11 March 2019. The Programme should also foster measures to strengthen the assessment and appropriate management of environmental risks associated with the production, use and disposal of medicinal products. (32) Union health legislation has an immediate impact on public health, on the lives of people, on the efficiency and resilience of health systems and on the proper functioning of the internal market. The regulatory framework for medical products and technologies, including medicinal products, medical devices and substances of human origin, and the regulatory frameworks for tobacco, patients’ rights in cross-border healthcare and serious cross-border threats to health, are essential to the protection of health in the Union. The Programme therefore should support the development, implementation and enforcement of Union health legislation and, in conjunction with relevant bodies such as EMA and ECDC, should provide high-quality, comparable and reliable data, including real-world healthcare data, to support policymaking and monitoring, set targets and develop tools to measure progress. (33) European Reference Networks (ERNs), which were established pursuant to Directive 2011/24/EU of the European Parliament and of the Council (14), are virtual networks of healthcare providers across Europe. They aim to facilitate discussion regarding complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As ERNs can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through ERNs and other transnational networks. (34) ERNs and cross-border cooperation in the provision of healthcare to patients moving between Member States are examples of areas where integrated work between Member States has been shown to have strong added value and great potential to increase the efficiency of health systems and thus to improve public health in general. Collaboration as regards HTA is another area that is bringing added value to Member States. The Programme should therefore support activities that enable integrated and sustained coordinated work, thereby also serving to foster the implementation of best practices that are aimed at distributing the available resources to the population and areas concerned in the most effective way so as to maximise their impact. (35) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (15) (the ‘Financial Regulation’) applies to this Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (36) The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions concerned and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. That choice should include consideration of the use of lump sums, flat-rate financing and unit costs, as well as the use of financing that is not linked to costs as envisaged in Article 125(1) of the Financial Regulation. Technical and financial reporting requirements for the beneficiaries should be such as to ensure that there is compliance with applicable financial provisions while minimising the administrative burden. (37) In order to optimise the added value and impact from investments funded wholly or in part through the budget of the Union, synergies should be sought in particular between the Programme and other Union programmes, including those under shared-management. To maximise those synergies, and avoid duplications, appropriate mechanisms should be provided for, including cumulative funding in an action from the Programme and another Union programme, as long as such cumulative funding does not exceed the total eligible costs of the action. For that purpose, this Regulation should set out appropriate rules, in particular on the possibility of declaring the same cost or expenditure on a pro-rata basis under the Programme and another Union programme, in order to ensure that there is detailed and transparent reporting. (38) Given the specific nature of the objectives and actions covered by the Programme, the respective competent authorities of the Member States will be best placed, in some cases, to implement actions related to the Programme. Those authorities, designated by the Member States, should therefore be considered to be identified beneficiaries for the purpose of Article 195 of the Financial Regulation and grants should therefore be awarded to those authorities without the prior publication of calls for proposals. Investments under the Programme should be implemented in close cooperation with Member States. (39) Under Article 193(2) of the Financial Regulation, a grant may be awarded for an action, which has already begun, provided that the applicant can demonstrate the need to start the action prior to the signature of the grant agreement. However, costs incurred prior to the date of submission of the grant application are not eligible costs, except in duly justified exceptional cases. In order to avoid any disruption to Union support which could be prejudicial to the Union’s interests, it should be possible to provide for the eligibility of activities and costs from the beginning of the 2021 financial year in the financing decision, for a limited period at the beginning of the multiannual financial framework 2021-2027, and only in duly justified cases, even if those activities were implemented and those costs were incurred before the grant application was submitted. (40) ERNs are approved by the Board of Member States of the ERNs, following the approval procedure set out in Commission Implementing Decision 2014/287/EU (16). ERNs should therefore be considered to be identified beneficiaries for the purpose of Article 195 of the Financial Regulation, and the grants to ERNs should therefore be awarded without prior publication of calls for proposals. Direct grants should also be awarded to other entities that have been designated in accordance with Union rules, for example reference laboratories and centres, centres of excellence and transnational networks. (41) Given the commonly agreed values of solidarity in relation to equitable and universal coverage of quality health services as a basis for the Union’s policies in this area and the fact that the Union has a central role to play in accelerating progress, coordination and cooperation in tackling global health challenges as set out in the Council conclusions of 10 May 2010 on the EU role in Global Health, and as expressed in the UN 2030 Agenda Sustainable Development Goals, the Programme should reinforce the Union’s support for international and global health initiatives, in particular for initiatives by the WHO, with a view to improving health, addressing health inequalities and strengthening protection against global health threats. (42) In order to maximise the effectiveness and efficiency of actions at Union and international level, cooperation should be developed with relevant international organisations such as the United Nations and the World Bank, as well as with the Council of Europe and the Organisation for Economic Co-operation and Development (OECD), when implementing the Programme. In order to increase impact, synergies should also be sought with the national organisations of Member States that are active in global health. In accordance with Council Decision 2013/755/EU (17), persons and entities established in Overseas Countries and Territories (OCTs) should be eligible for funding under the Programme, subject to the rules and objectives of the Programme and to possible arrangements applicable to the Member State to which the relevant OCTs are linked. (43) The implementation of the Programme should be supported by extensive outreach activities to ensure that the views and needs of civil society are duly represented and taken into account. To this end, the Commission should seek feedback on the Programme’s priorities and strategic orientations and on the needs to be addressed through its actions from relevant stakeholders once a year, including from representatives of civil society and patients’ associations, academics and organisations of healthcare professionals. Each year, before the end of the preparatory work for the work programmes, the Commission should also inform the European Parliament about the progress regarding such preparatory work and on the outcome of its outreach activities towards stakeholders. (44) Third countries which are members of the European Economic Area (EEA) are able to participate in Union programmes in the framework of the cooperation established under the Agreement on the European Economic Area (18), which provides for the implementation of such programmes on the basis of a decision adopted under that agreement. A specific provision should be introduced in this Regulation requiring third countries that participate in the Programme to grant the necessary rights and access required for the authorising officer responsible, the European Anti-Fraud Office (OLAF) and the Court of Auditors to comprehensively exercise their respective competences. (45) Cooperation with third countries should be strengthened as regards the exchange of knowledge and best practices in order to improve health systems’ preparedness and response capacity. (46) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (19) and Council Regulations (EC, Euratom) No 2988/95 (20), (Euratom, EC) No 2185/96 (21) and (EU) 2017/1939 (22), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, OLAF has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor’s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union, as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (23). (47) In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (48) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes, indirect implementation, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (49) Reflecting the importance of tackling climate change in line with the Union’s commitments to implement the Paris Agreement adopted under the United Nations Framework Convention on Climate Change and the UN Agenda 2030 Sustainable Development Goals, the Programme should contribute to mainstreaming climate action in the Union’s policies and to the achievement of an overall target of at least 30 % of the total amount of the Union budget and the European Union Recovery Instrument, established by Council Regulation (EU) 2020/2094 (24), expenditures, supporting climate objectives. The Programme should support activities that would respect the climate and environmental standards and priorities of the Union and the ‘do no harm’ principle of the European Green Deal. Relevant actions should be identified during the Programme’s preparation and implementation, and reassessed in the context of its interim evaluation. (50) According to Article 8 TFEU, in all its activities, the Union shall aim to eliminate inequalities and to promote equality between men and women. Gender equality, as well as rights and equal opportunities for all, and the mainstreaming of those objectives should be taken into account and promoted throughout the assessment, preparation, implementation and monitoring of the Programme. (51) It should be possible for the policy objectives of the Programme to also be addressed through financial instruments and budgetary guarantees under the InvestEU Fund provided for by the InvestEU Programme. Financial support should be used to address market failures and sub-optimal investment situations, in a proportionate manner. Actions funded by the Programme should not duplicate or crowd out private financing or distort competition in the internal market. In general, actions should have Union added value. (52) The implementation of the Programme should be such that the responsibilities of the Member States for the definition of their health policies and for the organisation and delivery of health services and medical care are respected. Strong involvement of Member States in the governance and implementation of the Programme should be ensured. (53) Given the nature and potential scale of cross-border threats to health, the objectives of protecting people in the Union from such threats and increasing health crisis prevention and preparedness cannot be sufficiently achieved by the Member States acting alone. In accordance with the principle of subsidiarity as set out in Article 5 TEU, action at Union level can also be taken to support Member States’ efforts in the pursuit of a high level of protection of public health, to improve the availability, sustainability, acceptability, accessibility, safety and affordability in the Union of medicinal products, medical devices and crisis-relevant products and services, to support innovation, to support integrated and coordinated work and the implementation of best practices among Member States, and to address inequalities and inequities in access to healthcare throughout the Union in a manner that creates efficiency gains and value-added impacts that could not be generated by action taken at national level, while respecting the Member States’ competence and responsibility in the areas covered by the Programme. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (54) In order to allow possible adjustments necessary to achieve the Programme’s objectives to be made, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the review, amendment and addition of the indicators set out in Annex II to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (25). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (55) Member States and participating countries have designated National Focal Points to assist the Commission in the promotion of the third Programme for the Union’s action in the field of health (2014-2020) established by Regulation (EU) No 282/2014, and, where relevant, in the dissemination of its results and the information available on its impact in the Member States and participating countries. Given the importance of such activities, it is appropriate to support such activities under the Programme in order to continue them. (56) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt implementing acts establishing annual work programmes in accordance with the criteria set out in this Regulation, approving certain eligible actions and establishing rules on technical and administrative arrangements necessary for the implementation of the actions of the Programme and on uniform templates for the collection of data necessary to monitor the implementation of the Programme. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of European Parliament and of the Council (26). The examination procedure should be used for the adoption of those implementing acts given that they relate to a programme with substantial implications. (57) The value and impact of the Programme should be regularly and closely monitored and evaluated. The evaluation should focus on the goals of the Programme and take into account the fact that the achievement of the Programme’s objectives could require a period that is longer than the length of the Programme. To that end, an interim evaluation report should be drawn up, as well as an evaluation report at the end of the Programme, in order to assess the implementation of the priorities of the Programme. (58) As the third Programme for the Union’s action in the field of health (2014-2020) has come to an end, Regulation (EU) No 282/2014 has become obsolete and should be repealed. (59) In order to ensure continuity in providing support in the field of health and to allow implementation to start from the beginning of the multiannual financial framework 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes the EU4Health Programme (the ‘Programme’) for the period of the multiannual financial framework 2021 to 2027. The duration of the Programme is aligned with the duration of the multiannual financial framework. This Regulation also lays down the objectives of the Programme, the budget for the period from 2021 to 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘associated country’ means a third country which is party to an agreement with the Union that allows for its participation in the Programme, in accordance with Article 6; (2) ‘blending operations’ means actions supported by the Union budget, including within blending facilities pursuant to point (6) of Article 2 of the Financial Regulation, combining non-repayable forms of support, and/or financial instruments from the Union budget with repayable forms of support from development institutions or other public finance institutions, as well as from commercial finance institutions and commercial investors; (3) ‘health crisis’ means a crisis or serious incident arising from a threat of human, animal, plant, food, biological, chemical, environmental or unknown origin, which has a public health dimension and which requires urgent action by authorities; (4) ‘crisis-relevant products’ means products, tools and substances that are necessary, in the context of a health crisis, for the prevention, diagnosis or treatment of a disease and its consequences, or for the monitoring and the epidemiological surveillance of diseases and infections, including, but not limited to, medicinal products, such as vaccines and their intermediates, active pharmaceutical ingredients and raw materials, as well as medical devices and hospital and medical equipment, such as ventilators, protective clothing and equipment, diagnostic materials and tools, personal protective equipment, disinfectants and their intermediary products, and the raw materials necessary for their production; (5) ‘One Health approach’ means a multisectoral approach which recognises that human health is connected to animal health and to the environment, and that actions to tackle threats to health must take into account those three dimensions; (6) ‘European Reference Networks (ERNs)’ means the networks referred to in Article 12 of Directive 2011/24/EU; (7) ‘legal entity’ means a natural person, or a legal person created and recognised as such under national, Union or international law which has legal personality and which can, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality as referred to in point (c) of Article 197(2) of the Financial Regulation; (8) ‘third country’ means a country that is not a Member State of the European Union; (9) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection; (10) ‘Health in All Policies’ means an approach to the development, implementation and review of public policies, regardless of the sector, whereby the health implications of decisions are taken into account, and which seeks to achieve synergies and to avoid harmful health impacts being caused by such policies, in order to improve the health of the population and health equity; (11) ‘health determinants’ means a range of factors that influence the health status of a person, such as behaviour-related, biological, socio-economic and environmental factors; (12) ‘emergency support’ means a needs-based emergency response that complements the response of the affected Member States and is aimed at preserving life, preventing and alleviating human suffering, and maintaining human dignity, wherever the need arises as a result of serious cross-border threats to health. Article 3 General objectives The Programme shall have a Union added value and complement the policies of the Member States, in order to improve human health throughout the Union and to ensure a high level of protection of human health in all Union policies and activities. It shall pursue the following general objectives in keeping with the One Health approach, where applicable: (a) improving and fostering health in the Union to reduce the burden of communicable and non-communicable diseases, by supporting health promotion and disease prevention, by reducing health inequalities, by fostering healthy lifestyles and by promoting access to healthcare; (b) protecting people in the Union from serious cross-border threats to health and strengthening the responsiveness of health systems and coordination among the Member States in order to cope with serious cross-border threats to health; (c) improving the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and supporting innovation regarding such products; (d) strengthening health systems by improving their resilience and resource efficiency, in particular through: (i) supporting integrated and coordinated work between Member States; (ii) promoting the implementation of best practices and promoting data sharing; (iii) reinforcing the healthcare workforce; (iv) tackling the implications of demographic challenges; and (v) advancing digital transformation. Article 4 Specific objectives The general objectives referred to in Article 3 shall be pursued through the following specific objectives, ensuring a high level of human health protection in all Union policies and activities in keeping with the One Health approach, where applicable: (a) in synergy with other relevant Union actions, supporting actions for disease prevention, for health promotion and for addressing health determinants, including through the reduction of damage to health resulting from illicit drug use and addiction, supporting actions to address inequalities in health, to improve health literacy, to improve patient rights, patient safety, quality of care and cross-border healthcare, and supporting actions for the improvement of the surveillance, diagnosis and treatment of communicable and non-communicable diseases, in particular cancer and paediatric cancer, as well as supporting actions to improve mental health, with special attention given to new care models and the challenges of long term care, in order to strengthen the resilience of the health systems in the Union; (b) strengthening the capability of the Union for prevention of, preparedness for, and rapid response to, serious cross-border threats to health in accordance with relevant Union legislation, and improving the management of health crises, particularly through the coordination, provision and deployment of emergency healthcare capacity, supporting data gathering, information exchange, surveillance, the coordination of voluntary stress testing of national healthcare systems, and the development of quality healthcare standards at national level; (c) supporting actions to enhance the availability, accessibility and affordability of medicinal products, medical devices and crisis-relevant products by encouraging sustainable production and supply chains and innovation in the Union, while supporting the prudent and efficient use of medicinal products, in particular antimicrobials, and actions to support the development of medicinal products that are less harmful for the environment, as well as the environmentally friendly production and disposal of medicinal products and medical devices; (d) in synergy with other Union instruments, programmes and funds, without prejudice to Member State competences, and in close cooperation with relevant Union bodies, supporting actions complementing national stockpiling of essential crisis-relevant products, at Union level, where needed; (e) in synergy with other Union instruments, programmes and funds, without prejudice to Member State competences and in close cooperation with the ECDC, establishing a structure and training resources for a reserve of medical, healthcare and support staff allocated voluntarily by Member States for its mobilisation in the event of a health crisis; (f) strengthening the use and re-use of health data for the provision of healthcare and for research and innovation, promoting the uptake of digital tools and services, as well as the digital transformation of healthcare systems, including by supporting the creation of a European health data space; (g) enhancing access to quality, patient-centred, outcome-based healthcare and related care services, with the aim of achieving universal health coverage; (h) supporting the development, implementation and enforcement and, where necessary, the revision of Union health legislation and supporting the provision of valid, reliable and comparable high-quality data for evidence-based decision-making and monitoring, and promoting the use of health impact assessments of other relevant Union policies; (i) supporting integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, supporting work on HTA, and strengthening and scaling up networking through ERNs and other transnational networks, including in relation to diseases other than rare diseases, to increase the coverage of patients and improve the response to low prevalence and complex communicable and non-communicable diseases; (j) supporting global commitments and health initiatives by reinforcing the Union’s support for actions by international organisations, in particular actions by the WHO, and fostering cooperation with third countries. Article 5 Budget 1. The financial envelope for the implementation of the Programme for the period 2021 - 2027 shall be EUR 2 446 000 000 in current prices. 2. As a result of the Programme-specific adjustment provided for in Article 5 of Council Regulation (EU, Euratom) 2020/2093 (27), the amount referred to in paragraph 1 of this Article shall be increased by an additional allocation of EUR 2 900 000 000 in 2018 prices as specified in Annex II to that Regulation. 3. The amounts referred to in paragraphs 1 and 2 may also be used for technical and administrative assistance for the implementation of the Programme, such as preparatory, monitoring, control, audit and evaluation activities including corporate information technology systems. 4. The distribution of the amounts referred to in paragraphs 1 and 2 shall comply with the following: (a) a minimum of 20 % of the amounts shall be reserved for health promotion and disease prevention actions as referred to in point (a) of Article 4; (b) a maximum of 12,5 % of the amounts shall be reserved for procurement complementing national stockpiling of essential crisis-relevant products at Union level as referred to in point (d) of Article 4; (c) a maximum of 12,5 % of the amounts shall be reserved for supporting global commitments and health initiatives as referred to in point (j) of Article 4; (d) a maximum of 8 % of the amounts shall be reserved for covering administrative expenses as referred to in paragraph 3. 5. Appropriations related to activities under point (c) of Article 9(1) of this Regulation, shall constitute assigned revenue within the meaning of point (a) of paragraph 3, and paragraph 5, of Article 21 of the Financial Regulation. 6. Budgetary commitments extending over more than one financial year may be broken down over several years into annual instalments. 7. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation, for a limited period in duly justified cases specified in the financing decision, activities supported under this Regulation and their underlying costs may be considered eligible as of 1 January 2021, even if those activities were implemented and those costs were incurred before the grant application was submitted. 8. If necessary, appropriations may be entered in the budget beyond 31 December 2027 to cover the expenses referred to in paragraph 3 to enable the management of actions not completed by 31 December 2027. Article 6 Third countries associated to the Programme 1. The Programme shall be open to the participation of the following third countries: (a) members of the European Free Trade Association which are members of the European Economic Area, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions, or similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions, or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country in any Union programme, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programme; (ii) lays down the conditions of participation in the Union programme, including the calculation of financial contributions to individual programmes, and their administrative costs; (iii) does not confer on the third country a decision-making power in respect of the Union programme; (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests. 2. The contributions referred to in point (d)(ii) of paragraph 1 shall constitute assigned revenue in accordance with Article 21(5) of the Financial Regulation. CHAPTER II FUNDING Article 7 Implementation and forms of Union funding 1. The Programme shall be implemented in direct management in accordance with the Financial Regulation or in indirect management with the bodies referred to in point (c) of Article 62(1) of that Regulation. 2. The Programme may provide funding in any of the forms laid down in the Financial Regulation, in particular in the form of grants, prizes and procurement. 3. Contributions to a mutual insurance mechanism may cover the risk associated with the recovery of funds due by recipients and may be considered as a sufficient guarantee under the Financial Regulation. The Commission shall lay down specific rules for the operation of the mechanism. 4. Where the Commission implements emergency support operations through a non-governmental organisation, the criteria concerning financial and operational capacity shall be deemed to be satisfied if there is a framework partnership agreement in force between that organisation and the Commission pursuant to Council Regulation (EC) No 1257/96 (28). Article 8 Grants 1. Grants under the Programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation. 2. Grants may be used in combination with financing from the European Investment Bank, from national promotional banks or from other development or public financial institutions, as well as in combination with financing from private-sector finance institutions and from public-sector or private-sector investors, including through public-public or public-private partnerships. 3. Grants paid by the Union shall not exceed 60 % of eligible costs for an action relating to an objective of the Programme or for the functioning of a non-governmental body. In cases of exceptional utility, the contribution by the Union may be up to 80 % of eligible costs. Actions with a clear Union added value shall be considered to have exceptional utility, inter alia, where: (a) at least 30 % of the budget of the proposed action is allocated to Member States whose GNI per inhabitant is less than 90 % of the Union average; or (b) bodies from at least 14 participating Member States participate in the action, of which at least four are Member States whose GNI per inhabitant is less than 90 % of the Union average. 4. In the case of the direct grants referred to in Article 13(6) and (7), such grants may be up to 100 % of eligible costs. Article 9 Procurement in health emergency situations 1. In cases where the emergence or development of a serious cross-border threat to health has been notified under Article 9 of Decision No 1082/2013/EU, or where a situation of public health emergency has been recognised under Article 12 of that Decision, procurement under this Regulation may take any of the following forms: (a) joint procurement with the Member States as referred to in Article 165(2) of the Financial Regulation whereby Member States may acquire, rent or lease fully the jointly procured capacities; (b) procurement by the Commission on behalf of the Member States on the basis of an agreement between the Commission and the Member States; (c) procurement by the Commission acting as wholesaler by buying, stocking and reselling or donating supplies and services, including rentals, for the benefit of Member States or partner organisations selected by the Commission. 2. In the event of the procurement procedure referred to in point (b) of paragraph 1 being used, the ensuing contracts shall be concluded by either of the following: (a) by the Commission, where the services or goods are to be provided or delivered to Member States or to partner organisations selected by the Commission; (b) by the participant Member States, where they are to directly acquire, rent or lease the capacities procured for them by the Commission. 3. In the event of the procurement procedures referred to in points (b) and (c) of paragraph 1 being used, the Commission shall comply with the Financial Regulation for its own procurement. Article 10 Blending operations Blending operations under the Programme shall be implemented in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation. Article 11 Cumulative funding 1. An action that has received a contribution under the Programme may also receive a contribution from any other Union programme, including Funds under shared management, provided that the contributions do not cover the same costs. 2. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. 3. The cumulative funding shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. CHAPTER III ACTIONS Article 12 Eligible actions Only actions that implement the objectives listed in Articles 3 and 4, in particular the actions set out in Annex I, shall be eligible for funding. Article 13 Eligible legal entities 1. In order to be eligible for funding, legal entities shall, in addition to the criteria set out in Article 197 of the Financial Regulation: (a) be established in any of the following: (i) a Member State or an overseas country or territory linked to it; (ii) a third country associated to the Programme; or (iii) a third country listed in the annual work programme established in accordance with Article 17 (‘annual work programme’) under the conditions specified in paragraphs 2 and 3; or (b) be a legal entity created under Union law or an international organisation. 2. Legal entities that are established in a third country which is not associated to the Programme may in exceptional cases be eligible to participate in the Programme where such participation is necessary for the achievement of the objectives of a given action. The assessment of that necessity shall be duly reflected in the funding decision. 3. Legal entities that are established in a third country which is not associated to the Programme shall bear the cost of their participation. 4. Natural persons shall not be eligible for grants under the Programme. 5. Under the Programme, direct grants may be awarded without a call for proposals to fund actions, if such grants are duly justified, and if those actions have a Union added value that is explicitly provided for in the annual work programmes and are co-financed by the competent authorities that are responsible for health in the Member States or in third countries associated to the Programme, by relevant international health organisations, or by public sector bodies or non-governmental bodies that are mandated by those competent authorities, regardless of whether those bodies act individually or as a network. 6. Under the Programme, direct grants shall be awarded without a call for proposals to ERNs. Direct grants may also be awarded to other transnational networks set out in accordance with Union law. 7. Under the Programme, direct grants may be awarded without a call for proposals to fund actions of the WHO where financial support is necessary for the implementation of one or more of the specific objectives of the Programme that have a Union added value that is explicitly provided for in the annual work programmes. 8. Under the Programme, grants may be awarded without a call for proposals to fund the functioning of non-governmental bodies where financial support is necessary for the implementation of one or more of the specific objectives of the Programme that have a Union added value that is explicitly provided for in the annual work programmes, as long as those bodies fulfil all of the following criteria: (a) they are non-profit-making and independent of industry, commercial and business or other conflicting interests; (b) they work in the public health area, pursue at least one of the specific objectives of the Programme and play an effective role at Union level; (c) they are active at Union level and in at least half of the Member States, with a balanced geographical coverage of the Union. The Commission shall duly reflect the analysis of the fulfilment of those criteria in the funding decision. Article 14 Eligible costs 1. Subject to Article 186 of the Financial Regulation, and point (a) of the second subparagraph of Article 193(2) of that Regulation, costs incurred prior to the date of submission of the grant application shall be eligible for funding with respect to actions: (a) implementing the objective referred to in point (b) of Article 3 of this Regulation; or (b) implementing objectives other than those referred to in point (a) of this paragraph, in duly justified exceptional cases, provided that those costs are directly linked to the implementation of the supported actions and activities. 2. Costs eligible under point (a) of paragraph 1 that relate to measures aiming to address suspected occurrences of a disease that could trigger a cross-border threat to health shall be eligible from the date of notification of the suspected occurrence of that disease to the Commission, provided that the occurrence or presence of that disease is subsequently confirmed. 3. In exceptional cases, during a health crisis caused by a serious cross-border threat to health as defined in point (g) of Article 3 of Decision No 1082/2013/EU, costs incurred by entities established in non-associated countries may be considered eligible if those costs are duly justified for reasons concerning countering the spread of the risk for the protection of the health of people in the Union. CHAPTER IV GOVERNANCE Article 15 Joint policy implementation 1. A EU4Health Steering Group shall be established. 2. The Members of the EU4Health Steering Group shall be the Commission and the Member States. Each Member State shall appoint one member and one alternate member to the EU4Health Steering Group. The Commission shall provide the secretariat of the EU4Health Steering Group. 3. The Commission shall consult the EU4Health Steering Group: (a) on the Commission’s preparatory work for the annual work programmes; (b) each year, at least 6 months in advance of the presentation of the draft of the annual work programme to the committee referred to in Article 23(1), on the priorities and strategic orientations of the annual work programme. 4. The EU4Health Steering Group shall: (a) work towards ensuring that there is consistency and complementarity between the Member States’ health policies as well as between the Programme and other policies, instruments and actions of the Union, including those relevant to the Union agencies; (b) follow up the implementation of the Programme and propose any necessary adjustments based on evaluations; (c) adopt its rules of procedure, which shall contain provisions to ensure that the group will meet at least three times a year, in person where appropriate, thus allowing for a regular and transparent exchange of views among Member States. Article 16 Stakeholder consultation and information of the European Parliament 1. The Commission shall consult with relevant stakeholders, including representatives of civil society and patient organisations, to seek their views on: (a) the priorities and strategic orientation of the annual work programme; (b) the needs to be addressed through the annual work programme and the results achieved through it. 2. For the purposes of paragraph 1, the Commission shall organise the consultation and information of stakeholders at least once a year, in the six months preceding the presentation of the draft work programme to the committee referred to in Article 23(1). 3. The Commission may at any time seek the views of relevant decentralised agencies and of independent experts in the field of health on technical or scientific matters of relevance for the implementation of the Programme. 4. Each year, prior to the last meeting of the EU4Health Steering Group, the Commission shall present to the European Parliament the outcomes of the proceedings of the EU4Health Steering Group and the consultation of stakeholders referred to in paragraphs 1 and 2. Article 17 Implementation of the Programme 1. The Commission shall implement the Programme by establishing annual work programmes in accordance with the Financial Regulation. 2. The Commission shall adopt, by means of implementing acts: (a) the annual work programmes, which shall set out, in particular: (i) the actions to be undertaken, including the indicative allocation of financial resources; (ii) the overall amount reserved for blending operations; (iii) eligible actions falling under Article 7(3) and (4); (iv) eligible actions by legal entities referred to in point (b) of Article 13(1); (v) eligible actions by legal entities from a third country not associated to the Programme but listed in the annual work programme under the conditions laid down in Article 13(2) and (3); (b) decisions approving actions with a cost of EUR 20 000 000 or more; (c) rules establishing: (i) the technical and administrative arrangements necessary for the implementation of the actions of the Programme; (ii) uniform templates for the collection of data necessary to monitor the implementation of the Programme. 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(2). Article 18 Data protection In managing and implementing the Programme, the Commission and the Member States shall ensure that there is compliance with all relevant legal provisions regarding personal data protection and, where appropriate, that mechanisms are introduced to ensure that such data remain confidential and safe. CHAPTER V MONITORING, EVALUATION AND CONTROL Article 19 Monitoring and reporting 1. Indicators to report on progress of the Programme towards the achievement of the general and specific objectives listed in Articles 3 and 4 are set out in Annex II. 2. The Commission is empowered to adopt delegated acts in accordance with Article 25 to amend Annex II with regard to the indicators where considered necessary. 3. The performance reporting system shall ensure that data for monitoring programme implementation and results are collected efficiently, effectively, and in a timely manner. To that end, the Commission shall adopt implementing acts establishing proportionate reporting requirements for recipients of Union funds and, where appropriate, for Member States. Article 20 Evaluation 1. Evaluations provided for in Article 34(3) of the Financial Regulation shall be carried out by the Commission in a sufficiently timely manner to feed into the decision-making process. 2. The Commission shall present an interim evaluation of the Programme no later than 31 December 2024. The interim evaluation shall be the basis for adjusting the implementation of the Programme as appropriate. 3. The Commission shall present a final evaluation at the end of the Programme and no later than four years after the end of the period referred to in Article 1. 4. The Commission shall publish and communicate the conclusions of both the interim and final evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Article 21 Audits Audits of the use of Union contributions, including audits carried out by persons or entities other than those mandated by the Union institutions or bodies, shall form the basis of the overall assurance referred to in Article 127 of the Financial Regulation. Article 22 Protection of the financial interests of the Union Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF, and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. Article 23 Committee procedure 1. The Commission shall be assisted by a EU4Health Programme Committee. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 24 Consistency and complementarity with other Union policies, instruments and actions The Commission and the Member States shall ensure that there is overall consistency, synergy and complementarity between the Programme and other Union policies, instruments and actions, including those relevant to the Union agencies, including through their common work in the EU4Health Steering Group. Article 25 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 19(2) shall be conferred on the Commission for a period of seven years from 26 March 2021. 3. The delegation of power referred to in Article 19(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 19(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. CHAPTER VI TRANSITIONAL AND FINAL PROVISIONS Article 26 Information, communication and publicity 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions related to the Programme, to actions taken pursuant to the Programme and to the results obtained. 3. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Articles 3 and 4. Article 27 Repeal Regulation (EU) No 282/2014 is repealed with effect from 1 January 2021, without prejudice to Article 28 of this Regulation. Article 28 Transitional provisions 1. This Regulation shall not affect the continuation of or modification of actions initiated pursuant to Regulation (EU) No 282/2014 which shall continue to apply to those actions until their closure. 2. The financial envelope for the Programme may also cover technical and administrative assistance expenses necessary to ensure the transition between the measures adopted under Regulation (EU) No 282/2014 and the Programme. Article 29 Entry into force and application This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 March 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A.P. ZACARIAS (1) OJ C 429, 11.12.2020, p. 251. (2) OJ C 440, 18.12.2020, p. 131. (3) Position of the European Parliament of 9 March 2021 (not yet published in the Official Journal) and decision of the Council of 17 March 2021. (4) Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008) (OJ L 271, 9.10.2002, p. 1). (5) Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007 establishing a second programme of Community action in the field of health (2008-13) (OJ L 301, 20.11.2007, p. 3). (6) Regulation (EU) No 282/2014 of the European Parliament and of the Council of 11 March 2014 on the establishment of a third Programme for the Union’s action in the field of health (2014-2020) and repealing Decision No 1350/2007/EC (OJ L 86, 21.3.2014, p. 1). (7) OJ L 433I, 22.12.2020, p. 28. (8) OJ C 444I, 22.12.2020, p. 1. (9) Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). (10) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (see page 30 of this Official Journal). (11) Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17). (12) Decision (EU) 2019/420 of the European Parliament and of the Council of 13 March 2019 amending Decision No 1313/2013/EU on a Union Civil Protection Mechanism (OJ L 77I , 20.3.2019, p. 1). (13) Council Regulation (EU) 2016/369 of 15 March 2016 on the provision of emergency support within the Union (OJ L 70, 16.3.2016, p. 1). (14) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). (15) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (16) Commission Implementing Decision 2014/287/EU of 10 March 2014 setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks (OJ L 147, 17.5.2014, p. 79). (17) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (‘Overseas Association Decision’) (OJ L 344, 19.12.2013, p. 1). (18) OJ L 1, 3.1.1994, p. 3. (19) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (20) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (21) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (22) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1). (23) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (24) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433I , 22.12.2020, p. 23). (25) OJ L 123, 12.5.2016, p. 1. (26) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (27) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433I, 22.12.2020, p. 11). (28) Council Regulation (EC) No 1257/96 of 20 June 1996 concerning humanitarian aid (OJ L 163, 2.7.1996, p. 1). ANNEX I LIST OF POSSIBLE ELIGIBLE ACTIONS PROVIDED FOR IN ARTICLE 12 1. Actions meeting the objective laid down in point (a) of Article 4 (a) Supporting the establishment and implementation of programmes assisting Member States and supporting the actions of Member States to improve health promotion and disease prevention; (b) Supporting the implementation and further development of surveys, studies, collection of comparable data and statistics, where relevant including disaggregated data by gender and age, methodologies, classifications, microsimulations, pilot studies, indicators, knowledge brokering and benchmark exercises; (c) Supporting Member States’ actions to put in place healthy and safe urban, work and school environments, to enable healthy life choices, to promote healthy diets and regular physical activity, taking into account the needs of vulnerable groups at every stage of their life, with the aim of promoting life-long health; (d) Supporting Member States in delivering effective responses to communicable diseases, and in the prevention, surveillance, diagnosis and treatment of such diseases; (e) Supporting Member States’ actions in health promotion and disease prevention throughout the lifetime of an individual and by addressing health risk factors, such as obesity, unhealthy diets and physical inactivity; (f) Supporting actions to improve mental health; (g) Supporting actions to complement measures of Member States in reducing damage to health due to illicit drug use and addiction, including information and prevention; (h) Supporting implementing policies and actions to reduce health inequalities and inequities in relation to healthcare; (i) Supporting actions to enhance health literacy; (j) Supporting the promotion and implementation of the recommendations of the European Code against Cancer and supporting the revision of the current edition of that Code; (k) Actions to support the implementation of cancer registries in all Member States; (l) Furthering the cooperation among relevant national bodies of participating Member States with a view to supporting the creation of a virtual European network of excellence in order to strengthen research on all types of cancer, including paediatric cancer, and further the collection and exchange of clinical data and the translation of research findings into everyday care and treatment of cancer patients; (m) Supporting actions to improve the quality of cancer care, including as regards prevention, screening, early diagnosis, monitoring and treatment, supportive and palliative care, in an integrative and patient-centred approach and supporting the establishment of quality assurance schemes for cancer centres or other centres treating cancer patients, including those treating paediatric cancer; (n) Supporting the establishment of quality assurance schemes for cancer centres and centres treating cancer patients; (o) Supporting mechanisms for cross-specialty capacity building and continuous education, in particular in the area of cancer care; (p) Actions supporting the quality of life of cancer survivors and caregivers, including provision of psychological support, pain management and health-related aspects of professional reintegration; (q) Strengthening collaboration on patient rights, patient safety and quality of care; (r) Supporting actions regarding epidemiological surveillance, thus contributing to assessment of factors that affect or determine the health of people; (s) Supporting, in synergy with other programmes, actions to improve the geographical distribution of the healthcare workforce and actions for the avoidance of ‘medical deserts’, without prejudice to Member State competences; (t) Supporting the development of guidelines for preventing and managing communicable and non-communicable diseases, and of tools and networks for the exchange of best practices in that area; (u) Supporting Member States’ actions to address health determinants, including reducing alcohol-related harm and tobacco use; (v) Supporting tools and platforms to collect real-world evidence on the safety, effectiveness and impact of vaccines after use; (w) Supporting initiatives to improve vaccination coverage rates in the Member States; (x) Communication activities addressed to the public and stakeholders to promote Union action in the areas mentioned in this Annex; (y) Awareness-raising campaigns and communications activities for the general public as well as for targeted groups, aimed at preventing and addressing vaccine hesitancy, misinformation and disinformation as regards prevention, causes and treatment of diseases, in a manner that complements national campaigns and communications activities on those matters; (z) Communication activities addressed to the public on health risks and health determinants; (za) Supporting actions to reduce the risk of healthcare-acquired infections. 2. Actions meeting the objective laid down in point (b) of Article 4 (a) Strengthening the critical health infrastructure to cope with health crises, by supporting the setup of tools for surveillance, forecast, prevention and management of outbreaks; (b) Supporting actions to foster Union-wide health crisis prevention and preparedness, and the management capacity and response capacity of actors at Union and national level, including voluntary stress tests, contingency planning and preparedness exercises; supporting the development of quality health standards at national level, mechanisms for the efficient coordination of preparedness and response, and the coordination of those actions at Union level; (c) Supporting actions for setting up an integrated cross-cutting risk communication framework covering all phases of a health crisis, namely prevention, preparedness, response and recovery; (d) Supporting preventive actions to protect vulnerable groups from health threats and actions to adapt the response to and the management of health crises to the needs of those vulnerable groups such as actions to secure basic care for patients with chronic or rare diseases; (e) Supporting actions to address the collateral health consequences of a health crisis, in particular the consequences for mental health, on patients suffering from cancer, from chronic diseases and other vulnerable situations, including people living with addiction, with HIV/AIDS, or suffering from hepatitis and tuberculosis; (f) Supporting, in synergy with other programmes, training and educational programmes for the upskilling of healthcare and public health workforces, and programmes for temporary exchanges of staff, in particular with the aim of improving their digital skills; (g) Supporting the establishment and coordination of Union Reference Laboratories, Union Reference Centres, and Centres of Excellence; (h) Auditing Member States’ preparedness and response arrangements, for example regarding health crisis management, antimicrobial resistance and vaccination; (i) Communicating to the public in the context of risk management and health crisis preparedness; (j) Supporting upwards convergence of national systems’ performance through health indicator development, analysis and knowledge brokering and the organisation of voluntary stress tests of national healthcare systems; (k) Supporting investigation, risk assessment and risk management work on the link between animal health, environmental factors, and human diseases, including during health crises. 3. Actions meeting the objective laid down in point (c) of Article 4 (a) Supporting actions to strengthen laboratory capacity and the production, research, development, and deployment of health products and crisis-relevant niche products within the Union; (b) Supporting actions and interoperable IT tools to monitor, prevent, manage, report and notify shortages of medicinal products and medical devices, while contributing to their affordability; (c) Supporting, in synergy with other programmes, clinical trials to speed up the development, market authorisation and access to innovative, safe and effective medicinal products and vaccines; (d) Supporting actions to encourage the development of innovative medicinal products and vaccines to meet rising healthcare challenges and patients’ needs, and of less commercially profitable products such as antimicrobials; (e) Supporting actions to improve the environmentally friendly production and disposal of medicinal products and medical devices and actions to support the development of medicinal products that are less harmful for the environment; (f) Supporting actions to promote the prudent and efficient use of medicinal products, in particular of antimicrobials; (g) Supporting actions aimed at stimulating the increase in the production of essential active pharmaceutical ingredients and medicinal products in the Union, including by diversifying supply chain production of active pharmaceutical ingredients and generics within the Union, to reduce Member States’ dependence on certain third countries; (h) Supporting actions to enhance the availability, accessibility and affordability of medicinal products and medical devices; (i) Supporting actions to foster innovation in repurposing, reformulation and combining of off-patent medicinal products, in synergy with other programmes; (j) Actions to strengthen the environmental risk assessment of medicinal products; (k) Supporting the establishment and operation of a mechanism for cross-sectorial coordination following the One-Health approach. 4. Actions meeting the objective laid down in point (d) of Article 4 (a) Monitoring of information on national stockpiling activities regarding essential crisis-relevant products to identify potential needs for additional stockpiling at Union level; (b) Ensuring consistent management of stockpiling of essential crisis-relevant products at Union level, in a manner that complements other Union instruments, programmes and funds and in close coordination with relevant Union bodies; (c) Supporting actions for the procurement and supply of essential crisis-relevant products, which contribute to their affordability, in a manner that complements Member States’ stockpiling actions. 5. Actions meeting the objective laid down in point (e) of Article 4 Supporting actions for the preparatory work for mobilising and training at Union level a reserve of medical, healthcare and support staff to be mobilised in the event of a health crisis, in close collaboration with the ECDC, in synergy with other Union instruments, and in full respect of Member State competences; facilitating the exchange of best practices between existing national reserves of medical, healthcare and support staff. 6. Actions meeting the objective laid down in point (f) of Article 4 (a) Supporting a Union framework and the respective interoperable digital tools for cooperation among Member States and cooperation in networks, including those needed for HTA cooperation; (b) Supporting the deployment, operation and maintenance of mature, secure and interoperable digital service infrastructure and data quality assurance processes for the exchange of, access to, and use and reuse of, data; supporting cross-border networking, including through the use and interoperability of electronic health records, registries and other databases; developing appropriate governance structures and interoperable health information systems; (c) Supporting the digital transformation of healthcare and health systems, including through benchmarking and capacity building, for the uptake of innovative tools and technologies such as artificial intelligence, and supporting the digital upskilling of healthcare professionals; (d) Supporting the optimal use of telemedicine and telehealth, including through satellite communication for remote areas, fostering digitally-driven organisational innovation in healthcare facilities and promoting digital tools to support citizen empowerment and patient-centred care; (e) Supporting the development, operation and maintenance of databases and digital tools and their interoperability, including already established projects, where appropriate, with other sensing technologies, such as space-based technologies and artificial intelligence; (f) Supporting actions to strengthen citizens’ access to and control over their health data; (g) Supporting the deployment and interoperability of digital tools and infrastructure within and between Member States and with Union institutions, agencies and bodies; (h) Supporting preparatory activities and projects for the European health data space; (i) Actions to support e-health, such as the transition to telemedicine and at-home administration of medication; (j) Supporting the establishment of interoperable electronic health records, in line with the European Electronic Health Record Exchange format in order to increase the use of e-health and improve the sustainability and resilience of healthcare systems. 7. Actions meeting the objective laid down in point (g) of Article 4 (a) Actions promoting access to health services and related facilities and care for people with disabilities; (b) Supporting the strengthening of primary care and reinforcing the integration of care, with a view to providing universal health coverage and equal access to good quality healthcare; (c) Supporting Member States’ actions to promote access to sexual and reproductive healthcare and supporting integrated and intersectional approaches to prevention, diagnosis, treatment and care. 8. Actions meeting the objective laid down in point (h) of Article 4 (a) Supporting the establishment and operation of a health intelligence and knowledge infrastructure; (b) Supporting the implementation, enforcement, monitoring of Union health legislation and action; and providing technical support for the implementation of legal requirements; (c) Supporting studies and analysis, health impact assessment of other Union policy actions and the provision of scientific advice to support evidence-based policymaking; (d) Supporting expert groups and panels providing advice, data and information to support health policy development and implementation, including follow-up evaluations of the implementation of health policies; (e) Supporting national contact and focal points in providing guidance, information and assistance related to the promotion and implementation of Union health legislation and of the Programme; (f) Auditing and assessment work in accordance with Union legislation, where appropriate; (g) Supporting the implementation and further development of the Union’s tobacco control policy and legislation; (h) Supporting national systems as regards the implementation of legislation on substances of human origin, and as regards the promotion of the sustainable and safe supply of such substances through networking activities; (i) Supporting Member States to strengthen the administrative capacity of their healthcare systems through cooperation and exchange of best practices; (j) Supporting knowledge transfer actions and Union level cooperation to assist national reform processes towards improved effectiveness, accessibility, sustainability and resilience of health systems, while linking available Union funding; (k) Supporting capacity building for investing in and implementing health system reforms, including strategic planning and access to multi-source financing. 9. Actions meeting the objective laid down in point (i) of Article 4 (a) Supporting the transfer, adaptation and roll-out of best practices and innovative solutions with established Union level added-value between Member States, and in particular providing country-specific tailor-made assistance to the Member States, or groups of Member States, with the greatest needs, through the funding of specific projects including twinning, expert advice and peer support; (b) Supporting cross-border collaboration and partnerships, including in cross-border regions, with a view to transferring and upscaling innovative solutions; (c) Strengthening cross-sectoral collaboration and coordination; (d) Supporting the functioning of ERNs and the establishment and operation of new transnational networks as provided for in Union health legislation, and supporting Member States’ actions to coordinate the activities of such networks with the operation of national health systems; (e) Supporting further the implementation of ERNs in Member States and fostering their strengthening, inter alia, by continuous assessment, monitoring, evaluation and improvement; (f) Supporting the creation of new ERNs, to cover rare, complex and low prevalence diseases, where appropriate, and supporting collaboration among ERNs to address the multi-systemic needs arising from low prevalence diseases and rare diseases and to facilitate diagonal networking between different specialities and disciplines; (g) Support Member States to improve and further develop and implement ERN registries; (h) Stakeholder consultation activities. 10. Actions meeting the objective laid down in point (j) of Article 4 (a) Supporting actions contributing to the objectives of the programme presented by the WHO, as the directing and coordinating authority for health within the United Nations; (b) Supporting collaboration among Union institutions, Union agencies, and international organisations and networks, and supporting the Union’s contribution to global initiatives; (c) Supporting collaboration with third countries as regards the areas covered by the Programme; (d) Supporting actions to foster international regulatory convergence on medicinal products and medical devices. ANNEX II INDICATORS FOR THE EVALUATION OF THE PROGRAMME Programme indicators: 1. Preparedness and response planning of the Union and of Member States for serious cross-border threats to health 2. Access to centrally authorised medicinal products, for example the number of existing and new orphan authorisations, advanced therapy medicinal products (ATMPs), medicinal products for paediatric use or vaccines, for unmet needs 3. Number of actions contributing to the reduction of avoidable mortality in the area of non-communicable diseases and risk factors 4. Number of Member States implementing best practices regarding health promotion, disease prevention and addressing health inequalities 5. Number of Member States participating in the European health data space 6. Number of Member States with improved preparedness and response planning 7. Vaccination coverage by age for vaccine-preventable-diseases such as measles, flu, HPV and COVID-19 8. EU Laboratory capacity index (EULabCap) 9. Age-standardised five-year net survival rate for paediatric cancer by type, age, gender and Member State (to the extent available) 10. Screening coverage for breast, cervical and colorectal cancer screening programmes, by type, target population, and Member State 11. Percentage of population covered by Cancer Registries and number of Member States reporting information on cervical, breast, colorectal and paediatric cancer stage at diagnosis 12. Number of actions addressing the prevalence of major chronic diseases per Member State, by disease, gender and age 13. Number of actions addressing the age prevalence of tobacco use, if possible differentiated by gender 14. Number of actions addressing the prevalence of harmful use of alcohol, if possible differentiated by gender and age 15. Number of shortages of medicinal products in the Member States as reported through the single point of contact network 16. Number of actions aimed at increasing the security and continuity of the global supply chains and addressing dependence on imports from third countries for the production of essential active pharmaceutical ingredients and medicinal products in the Union 17. Number of audits conducted in the Union and in third countries to ensure good manufacturing practices and good clinical practices (Union control) 18. Antimicrobial consumption for systemic use ATC (group J01) per Member State 19. Number of healthcare units involved in ERNs and of patients diagnosed and treated by the members of ERNs 20. Number of HTA reports jointly carried out 21. Number of health impact assessments of Union policies 22. Number of actions addressing the fight against communicable diseases 23. Number of actions addressing environmental risk factors for health

EU4Health Programme (2021-2027) EU4Health Programme (2021-2027) SUMMARY OF: Regulation (EU) 2021/522 establishing a Programme for the EU’s action in the field of health (EU4Health Programme) for the period 2021-2027 WHAT IS THE AIM OF THE REGULATION? It establishes the EU4Health programme which, like the European Union (EU)’s multiannual financial framework (MFF), runs from 2021 to 2027. It sets out the programme’s: general and specific objectives; forms and rules of EU funding. KEY POINTS The programme brings EU added value, creating efficiency gains and value-added impacts that could not be achieved by actions taken only at national level. It supports and complements national policies to promote and improve human health in Europe and ensures human health protection in all EU policies and activities in line with the One Health approach*. The 4 general objectives are to: improve and foster health in the EU; protect people from serious cross-border health threats; improve medicines, medical devices and crisis-relevant products; strengthen health systems by improving their resilience and resource efficiency. These are implemented through 10 specific objectives as follows: to improve and foster health in the EU, the programme will support disease prevention and health promotioninternational health initiatives and cooperation; to reinforce EU Member States and the EU’s abilities to tackle cross-border health threats, the programme will support prevention, preparedness and response to cross-border health threatscomplementing national stockpiling of essential crisis-relevant productssetting up a reserve of medical, healthcare and support staff; to contribute to responding to the rising demand for healthcare and to fairer public health protection by supporting the improved availability, accessibility and affordability of medicinal products, medical devices and crisis-relevant products; to improve the resilience and resource efficiency of health systems, EU4Health will support actions that contribute to strengthening health data, digital tools and services, and the digital transformation of healthcareenhancing access to healthcaredeveloping and implementing EU health legislation and evidence-based decision-makingintegrated work among Member States’ health systems. Annex I to the regulation lists the many different activities eligible for EU funding under each of the 10 specific objectives. Recipients must acknowledge and ensure visibility of the EU finance they receive. In cases of a serious cross-border threat to health or a public health emergency, procurement under the programme may take the following forms and the European Commission may: jointly procure with Member States when they acquire, rent or lease fully the items procured; carry on procurement on behalf of Member States on the basis of an agreement; procure as a wholesaler buying, stocking and selling or donating supplies and services, for the benefit of the Member States and selected partner organisations. The 7-year programme’s budget is €2,446,000,000 (current prices). This is increased by an additional €2,900,000,000 (2018 prices) from the MFF. The total €5.3 billion of funds are distributed according to the following criteria: health promotion and disease prevention: minimum of 20%; procurement to complement national stockpiling of essential crisis products: maximum of 12.5%; global commitments and health initiatives: maximum of 12.5%; administrative expenses: maximum of 8%. The programme may provide funding in any of the forms laid down in the Financial Regulation, in particular in the form of grants, prizes and procurement. Grants should not exceed 60% of a project’s eligible costs, but this may rise to 80% where there is ‘exceptional utility’, as defined in Article 8. The grants may finance 100% of the eligible costs for actions of European Reference Networks (ERNs) or other transnational networks defined by EU law and, under certain conditions, for actions of the World Health Organisation (WHO). Non-EU countries may take part in the programme under certain conditions and only if they are associated with the programme. Governance rules provide for a consultative EU4Health steering groupcomposed of Commission and national representatives. This: ensures consistency and complementarity between national health policies, and between the programme and other EU measures; follows the programme’s implementation, proposing any necessary adjustments; meets at least 3 times a year so Member States can exchange views. The Commission is assisted by a EU4Health Programme Committee, which gives an opinion prior the adoption of the annual work programme by the Commission. If the Committee has no opinion or a negative opinion, the Commission cannot adopt the work programme. The Commission: consults the steering group when preparing the annual work programmes and informs the European Parliament before the last meeting of the steering group on the outcome of those meetings; seeks the views of relevant stakeholders, including civil society and patient organisations on the annual work programme’s priorities and strategic orientation as well as on the needs to be addressed and the achieved results; implements EU4Health through annual work programmes, which it adopts after a positive opinion of the Member States in the Programme Committee; will present an interim evaluation of the programme no later than 31 December 2024 and a final evaluation no later than the end of 2031 to the European Parliament, Council, European Economic and Social Committee and the Committee of the Regions; is assisted by an EU4Health Programme Committee; implements information and communication campaigns about the programme; has the power to adopt implementing and delegated acts. Annex II sets out the 23 indicators used to evaluate the programme’s progress. The regulation repeals Regulation (EU) No 282/2014 from 1 January 2021 with transitional rules to cover the transition to EU4Health. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND EU4Health is the EU’s response to the COVID-19 pandemic which has had a major impact on patients, medical and healthcare staff and health systems in Europe. It goes further than crisis response, to strengthen the resilience of healthcare systems with a strong focus on long-term health issues. For more information, see: EU4Health 2021-2027 — a vision for a healthier European Union (European Commission). KEY TERMS One Health approach: an approach which recognises that human health is closely linked to that of animals and the environment. MAIN DOCUMENT Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, pp. 1-29) RELATED DOCUMENTS Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, pp. 45-65) Successive amendments to Directive 2011/24/EU have been incorporated into the original text. This consolidated version is of documentary value only. last update 06.09.2021

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14.8.2009 EN Official Journal of the European Union L 211/36 REGULATION (EC) No 715/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 July 2009 on conditions for access to the natural gas transmission networks and repealing Regulation (EC) No 1775/2005 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas: (1) The internal market in natural gas, which has been progressively implemented since 1999, aims to deliver real choice for all consumers in the Community, be they citizens or businesses, new business opportunities and more cross-border trade, so as to achieve efficiency gains, competitive prices and higher standards of service, and to contribute to security of supply and sustainability. (2) Directive 2003/55/EC of the European Parliament and of the Council of 26 June 2003 concerning common rules for the internal market in natural gas (4) and Regulation (EC) No 1775/2005 of the European Parliament and of the Council of 28 September 2005 on conditions for access to the natural gas transmission networks (5) have made significant contributions towards the creation of such an internal market in natural gas. (3) Experience gained in the implementation and monitoring of a first set of Guidelines for Good Practice, adopted by the European Gas Regulatory Forum (the Madrid Forum) in 2002, demonstrates that in order to ensure the full implementation of the rules set out in those guidelines in all Member States, and in order to provide a minimum guarantee of equal market access conditions in practice, it is necessary to provide for them to become legally enforceable. (4) A second set of common rules entitled ‘the Second Guidelines for Good Practice’ was adopted at the meeting of the Madrid Forum on 24 and 25 September 2003 and the purpose of this Regulation is to lay down, on the basis of those guidelines, basic principles and rules regarding network access and third party access services, congestion management, transparency, balancing and the trading of capacity rights. (5) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas (6) provides for the possibility of a combined transmission and distribution system operator. The rules set out in this Regulation do not therefore require modification of the organisation of national transmission and distribution systems that are consistent with the relevant provisions of that Directive. (6) High-pressure pipelines linking up local distributors to the gas network which are not primarily used in the context of local distribution are included in the scope of this Regulation. (7) It is necessary to specify the criteria according to which tariffs for access to the network are determined, in order to ensure that they fully comply with the principle of non-discrimination and the needs of a well-functioning internal market and take fully into account the need for system integrity and reflect the actual costs incurred, insofar as such costs correspond to those of an efficient and structurally comparable network operator and are transparent, whilst including appropriate return on investments, and, where appropriate, taking account of the benchmarking of tariffs by the regulatory authorities. (8) In calculating tariffs for access to networks, it is important to take account of the actual costs incurred, insofar as such costs correspond to those of an efficient and structurally comparable network operator, and are transparent, as well as of the need to provide appropriate return on investments and incentives to construct new infrastructure, including special regulatory treatment for new investments as provided for in Directive 2009/73/EC. In that respect, and in particular if effective pipeline-to-pipeline competition exists, the benchmarking of tariffs by the regulatory authorities will be a relevant consideration. (9) The use of market-based arrangements, such as auctions, to determine tariffs has to be compatible with the provisions laid down in Directive 2009/73/EC. (10) A common minimum set of third-party access services is necessary to provide a common minimum standard of access in practice throughout the Community, to ensure that third party access services are sufficiently compatible and to allow the benefits accruing from a well-functioning internal market in natural gas to be exploited. (11) At present, there are obstacles to the sale of gas on equal terms, without discrimination or disadvantage in the Community. In particular, non-discriminatory network access and an equally effective level of regulatory supervision do not yet exist in each Member State, and isolated markets persist. (12) A sufficient level of cross-border gas interconnection capacity should be achieved and market integration fostered in order to complete the internal market in natural gas. (13) The Communication of the Commission of 10 January 2007 entitled ‘An Energy Policy for Europe’ highlighted the importance of completing the internal market in natural gas and creating a level playing field for all natural gas undertakings in the Community. The Communications of the Commission of 10 January 2007 entitled ‘Prospects for the internal gas and electricity market’ and ‘Inquiry pursuant to Article 17 of Regulation (EC) No 1/2003 into the European gas and electricity sectors (Final Report)’ demonstrated that the present rules and measures neither provide the necessary framework nor provide for the creation of interconnection capacities to achieve the objective of a well-functioning, efficient and open internal market. (14) In addition to thoroughly implementing the existing regulatory framework, the regulatory framework for the internal market in natural gas set out in Regulation (EC) No 1775/2005 should be adapted in line with those communications. (15) In particular, increased cooperation and coordination among transmission system operators is required to create network codes for providing and managing effective and transparent access to the transmission networks across borders, and to ensure coordinated and sufficiently forward looking planning and sound technical evolution of the transmission system in the Community, including the creation of interconnection capacities, with due regard to the environment. The network codes should be in line with framework guidelines which are non-binding in nature (framework guidelines) and which are developed by the Agency for the Cooperation of Energy Regulators established by Regulation (EC) No 713/2009 of the European Parliament and of the Council of 13 July 2009 establishing an Agency for the Cooperation of Energy Regulators (7) (the Agency). The Agency should have a role in reviewing, based on matters of fact, draft network codes, including their compliance with the framework guidelines, and it should be enabled to recommend them for adoption by the Commission. The Agency should assess proposed amendments to the network codes and it should be enabled to recommend them for adoption by the Commission. Transmission system operators should operate their networks in accordance with those network codes. (16) In order to ensure optimal management of the gas transmission network in the Community a European Network of Transmission System Operators for Gas (the ENTSO for Gas), should be established. The tasks of the ENTSO for Gas should be carried out in compliance with Community competition rules which remain applicable to the decisions of the ENTSO for Gas. The tasks of the ENTSO for Gas should be well-defined and its working method should ensure efficiency, transparency and the representative nature of the ENTSO for Gas. The network codes prepared by the ENTSO for Gas are not intended to replace the necessary national network codes for non cross-border issues. Given that more effective progress may be achieved through an approach at regional level, transmission system operators should set up regional structures within the overall cooperation structure, whilst ensuring that results at regional level are compatible with network codes and non-binding ten-year network development plans at Community level. Cooperation within such regional structures presupposes effective unbundling of network activities from production and supply activities. In the absence of such unbundling, regional cooperation between transmission system operators gives rise to a risk of anti-competitive conduct. Member States should promote cooperation and monitor the effectiveness of the network operations at regional level. Cooperation at regional level should be compatible with progress towards a competitive and efficient internal market in gas. (17) All market participants have an interest in the work expected of the ENTSO for Gas. An effective consultation process is therefore essential and existing structures set up to facilitate and streamline the consultation process, such as the European Association for the Streamlining of Energy Exchange, national regulators or the Agency should play an important role. (18) In order to ensure greater transparency regarding the development of the gas transmission network in the Community, the ENTSO for Gas should draw up, publish and regularly update a non-binding Community-wide ten-year network development plan (Community-wide network development plan). Viable gas transmission networks and necessary regional interconnections, relevant from a commercial or security of supply point of view, should be included in that network development plan. (19) To enhance competition through liquid wholesale markets for gas, it is vital that gas can be traded independently of its location in the system. The only way to do this is to give network users the freedom to book entry and exit capacity independently, thereby creating gas transport through zones instead of along contractual paths. The preference for entry-exit systems to facilitate the development of competition was already expressed by most stakeholders at the 6th Madrid Forum on 30 and 31 October 2002. Tariffs should not be dependent on the transport route. The tariff set for one or more entry points should therefore not be related to the tariff set for one or more exit points, and vice versa. (20) References to harmonised transport contracts in the context of non-discriminatory access to the network of transmission system operators do not mean that the terms and conditions of the transport contracts of a particular system operator in a Member State must be the same as those of another transmission system operator in that Member State or in another Member State, unless minimum requirements are set which must be met by all transport contracts. (21) There is substantial contractual congestion in the gas networks. The congestion-management and capacity-allocation principles for new or newly negotiated contracts are therefore based on the freeing-up of unused capacity by enabling network users to sublet or resell their contracted capacities and the obligation of transmission system operators to offer unused capacity to the market, at least on a day-ahead and interruptible basis. Given the large proportion of existing contracts and the need to create a true level playing field between users of new and existing capacity, those principles should be applied to all contracted capacity, including existing contracts. (22) Although physical congestion of networks is, at present, rarely a problem in the Community, it may become one in the future. It is important, therefore, to provide the basic principle for the allocation of congested capacity in such circumstances. (23) Market monitoring undertaken over recent years by the national regulatory authorities and by the Commission has shown that current transparency requirements and rules on access to infrastructure are not sufficient to secure a genuine, well-functioning, open and efficient internal market in gas. (24) Equal access to information on the physical status and efficiency of the system is necessary to enable all market participants to assess the overall demand and supply situation and to identify the reasons for movements in the wholesale price. This includes more precise information on supply and demand, network capacity, flows and maintenance, balancing and availability and usage of storage. The importance of that information for the functioning of the market requires alleviating existing limitations to publication for confidentiality reasons. (25) Confidentiality requirements for commercially sensitive information are, however, particularly relevant where data of a commercially strategic nature for the company are concerned, where there is only one single user for a storage facility, or where data are concerned regarding exit points within a system or subsystem that is not connected to another transmission or distribution system but to a single industrial final customer, where the publication of such data would reveal confidential information as to the production process of that customer. (26) To enhance trust in the market, its participants need to be sure that those engaging in abusive behaviour can be subjected to effective, proportionate and dissuasive penalties. The competent authorities should be given the competence to investigate effectively allegations of market abuse. To that end, it is necessary that competent authorities have access to data that provides information on operational decisions made by supply undertakings. In the gas market, all those decisions are communicated to the system operators in the form of capacity reservations, nominations and realised flows. System operators should keep information in relation thereto available to and easily accessible by the competent authorities for a fixed period of time. The competent authorities should, furthermore, regularly monitor the compliance of the transmission system operators with the rules. (27) Access to gas storage facilities and liquefied natural gas (LNG) facilities is insufficient in some Member States, and therefore the implementation of the existing rules needs to be improved. Monitoring by the European Regulators' Group for Electricity and Gas concluded that the voluntary guidelines for good third-party access practice for storage system operators, agreed by all stakeholders at the Madrid Forum, are being insufficiently applied and therefore need to be made binding. (28) Non-discriminatory and transparent balancing systems for gas, operated by transmission system operators, are important mechanisms, particularly for new market entrants which may have more difficulty balancing their overall sales portfolio than companies already established within a relevant market. It is therefore necessary to lay down rules to ensure that transmission system operators operate such mechanisms in a manner compatible with non-discriminatory, transparent and effective access conditions to the network. (29) The trading of primary capacity rights is an important part of developing a competitive market and creating liquidity. This Regulation should therefore lay down basic rules relating to such trading. (30) National regulatory authorities should ensure compliance with the rules contained in this Regulation and the Guidelines adopted pursuant thereto. (31) In the Guidelines annexed to this Regulation, specific detailed implementing rules are defined on the basis of the Second Guidelines for Good Practice. Where appropriate, those rules will evolve over time, taking into account the differences of national gas systems. (32) When proposing to amend the Guidelines annexed to this Regulation, the Commission should ensure prior consultation of all relevant parties concerned with the Guidelines, represented by the professional organisations, and of the Member States within the Madrid Forum. (33) The Member States and the competent national authorities should be required to provide relevant information to the Commission. Such information should be treated confidentially by the Commission. (34) This Regulation and the Guidelines adopted in accordance with it are without prejudice to the application of the Community rules on competition. (35) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8). (36) In particular, the Commission should be empowered to establish or adopt the Guidelines necessary for providing the minimum degree of harmonisation required to achieve the aims of this Regulation. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (37) Since the objective of this Regulation, namely the setting of fair rules for access conditions to natural gas transmission networks, storage and LNG facilities cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (38) Given the scope of the amendments that are being made herein to Regulation (EC) No 1775/2005, it is desirable, for reasons of clarity and rationalisation, that the provisions in question should be recast by bringing them all together in a single text in a new Regulation, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope This Regulation aims at: (a) setting non-discriminatory rules for access conditions to natural gas transmission systems taking into account the special characteristics of national and regional markets with a view to ensuring the proper functioning of the internal market in gas; (b) setting non-discriminatory rules for access conditions to LNG facilities and storage facilities taking into account the special characteristics of national and regional markets; and (c) facilitating the emergence of a well-functioning and transparent wholesale market with a high level of security of supply in gas and providing mechanisms to harmonise the network access rules for cross-border exchanges in gas. The objectives referred to in the first subparagraph shall include the setting of harmonised principles for tariffs, or the methodologies underlying their calculation, for access to the network, but not to storage facilities, the establishment of third-party access services and harmonised principles for capacity-allocation and congestion-management, the determination of transparency requirements, balancing rules and imbalance charges, and the facilitation of capacity trading. This Regulation, with the exception of Article 19(4), shall apply only to storage facilities falling under Article 33(3) or (4) of Directive 2009/73/EC. The Member States may establish an entity or body set up in compliance with Directive 2009/73/EC for the purpose of carrying out one or more functions typically attributed to the transmission system operator, which shall be subject to the requirements of this Regulation. That entity or body shall be subject to certification in accordance with Article 3 of this Regulation and shall be subject to designation in accordance with Article 10 of Directive 2009/73/EC. Article 2 Definitions 1. For the purpose of this Regulation, the following definitions apply: 1) ‘transmission’ means the transport of natural gas through a network, which mainly contains high-pressure pipelines, other than an upstream pipeline network and other than the part of high-pressure pipelines primarily used in the context of local distribution of natural gas, with a view to its delivery to customers, but not including supply; 2) ‘transport contract’ means a contract which the transmission system operator has concluded with a network user with a view to carrying out transmission; 3) ‘capacity’ means the maximum flow, expressed in normal cubic meters per time unit or in energy unit per time unit, to which the network user is entitled in accordance with the provisions of the transport contract; 4) ‘unused capacity’ means firm capacity which a network user has acquired under a transport contract but which that user has not nominated by the deadline specified in the contract; 5) ‘congestion management’ means management of the capacity portfolio of the transmission system operator with a view to optimal and maximum use of the technical capacity and the timely detection of future congestion and saturation points; 6) ‘secondary market’ means the market of the capacity traded otherwise than on the primary market; 7) ‘nomination’ means the prior reporting by the network user to the transmission system operator of the actual flow that the network user wishes to inject into or withdraw from the system; 8) ‘re-nomination’ means the subsequent reporting of a corrected nomination; 9) ‘system integrity’ means any situation in respect of a transmission network including necessary transmission facilities in which the pressure and the quality of the natural gas remain within the minimum and maximum limits laid down by the transmission system operator, so that the transmission of natural gas is guaranteed from a technical standpoint; 10) ‘balancing period’ means the period within which the off-take of an amount of natural gas, expressed in units of energy, must be offset by every network user by means of the injection of the same amount of natural gas into the transmission network in accordance with the transport contract or the network code; 11) ‘network user’ means a customer or a potential customer of a transmission system operator, and transmission system operators themselves in so far as it is necessary for them to carry out their functions in relation to transmission; 12) ‘interruptible services’ means services offered by the transmission system operator in relation to interruptible capacity; 13) ‘interruptible capacity’ means gas transmission capacity that may be interrupted by the transmission system operator in accordance with the conditions stipulated in the transport contract; 14) ‘long-term services’ means services offered by the transmission system operator with a duration of one year or more; 15) ‘short-term services’ means services offered by the transmission system operator with a duration of less than one year; 16) ‘firm capacity’ means gas transmission capacity contractually guaranteed as uninterruptible by the transmission system operator; 17) ‘firm services’ mean services offered by the transmission system operator in relation to firm capacity; 18) ‘technical capacity’ means the maximum firm capacity that the transmission system operator can offer to the network users, taking account of system integrity and the operational requirements of the transmission network; 19) ‘contracted capacity’ means capacity that the transmission system operator has allocated to a network user by means of a transport contract; 20) ‘available capacity’ means the part of the technical capacity that is not allocated and is still available to the system at that moment; 21) ‘contractual congestion’ means a situation where the level of firm capacity demand exceeds the technical capacity; 22) ‘primary market’ means the market of the capacity traded directly by the transmission system operator; 23) ‘physical congestion’ means a situation where the level of demand for actual deliveries exceeds the technical capacity at some point in time; 24) ‘LNG facility capacity’ means capacity at an LNG terminal for the liquefaction of natural gas or the importation, offloading, ancillary services, temporary storage and re-gasification of LNG; 25) ‘space’ means the volume of gas which a user of a storage facility is entitled to use for the storage of gas; 26) ‘deliverability’ means the rate at which the storage facility user is entitled to withdraw gas from the storage facility; 27) ‘injectability’ means the rate at which the storage facility user is entitled to inject gas into the storage facility; 28) ‘storage capacity’ means any combination of space, injectability and deliverability. 2. Without prejudice to the definitions in paragraph 1 of this Article, the definitions contained in Article 2 of Directive 2009/73/EC, which are relevant for the application of this Regulation, also apply, with the exception of the definition of transmission in point 3 of that Article. The definitions in points 3 to 23 of paragraph 1 of this Article in relation to transmission apply by analogy in relation to storage and LNG facilities. Article 3 Certification of transmission system operators 1. The Commission shall examine any notification of a decision on the certification of a transmission system operator as laid down in Article 10(6) of Directive 2009/73/EC as soon as it is received. Within two months of the day of receipt of such notification, the Commission shall deliver its opinion to the relevant national regulatory authority in regard to its compatibility with Article 10(2) or Article 11, and Article 9 of Directive 2009/73/EC. When preparing the opinion referred to in the first subparagraph, the Commission may request the Agency to provide its opinion on the national regulatory authority's decision. In such a case, the two-month period referred to in the first subparagraph shall be extended by two further months. In the absence of an opinion by the Commission within the periods referred to in the first and second subparagraphs, the Commission shall be deemed not to raise objections against the regulatory authority's decision. 2. Within two months of receiving an opinion of the Commission, the national regulatory authority shall adopt its final decision regarding the certification of the transmission system operator, taking the utmost account of that opinion. The regulatory authority's decision and the Commission's opinion shall be published together. 3. At any time during the procedure regulatory authorities and/or the Commission may request from a transmission system operator and/or an undertaking performing any of the functions of production or supply any information relevant to the fulfilment of their tasks under this Article. 4. Regulatory authorities and the Commission shall preserve the confidentiality of commercially sensitive information. 5. The Commission may adopt Guidelines setting out the details of the procedure to be followed for the application of paragraphs 1 and 2 of this Article. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(2). 6. Where the Commission has received notification of the certification of a transmission system operator under Article 9(10) of Directive 2009/73/EC, the Commission shall take a decision relating to certification. The regulatory authority shall comply with the Commission decision. Article 4 European network of transmission system operators for gas All transmission system operators shall cooperate at Community level through the ENTSO for Gas, in order to promote the completion and functioning of the internal market in natural gas and cross-border trade and to ensure the optimal management, coordinated operation and sound technical evolution of the natural gas transmission network. Article 5 Establishment of the ENTSO for Gas 1. By 3 March 2011, the transmission system operators for gas shall submit to the Commission and to the Agency the draft statutes, a list of members and draft rules of procedure, including the rules of procedures on the consultation of other stakeholders, of the ENTSO for Gas to be established. 2. Within two months of the day of the receipt, the Agency, after formally consulting the organisations representing all stakeholders, in particular the system users including customers, shall provide an opinion to the Commission on the draft statutes, list of members and draft rules of procedure. 3. The Commission shall deliver an opinion on the draft statutes, list of members and draft rules of procedures taking into account the opinion of the Agency provided for in paragraph 2 and within three months of the day of the receipt of the opinion of the Agency. 4. Within three months of the day of receipt of the Commission's opinion, the transmission system operators shall establish the ENTSO for Gas, adopt and publish its statutes and rules of procedure. Article 6 Establishment of network codes 1. The Commission shall, after consulting the Agency, the ENTSO for Gas and the other relevant stakeholders establish an annual priority list identifying the areas set out in Article 8(6) to be included in the development of network codes. 2. The Commission shall request the Agency to submit to it within a reasonable period of time not exceeding six months a non-binding framework guideline (framework guideline) setting out clear and objective principles, in accordance with Article 8(7), for the development of network codes relating to the areas identified in the priority list. Each framework guideline shall contribute to non-discrimination, effective competition and the efficient functioning of the market. Upon a reasoned request from the Agency, the Commission may extend that period. 3. The Agency shall formally consult the ENTSO for Gas and the other relevant stakeholders in regard to the framework guideline, during a period of no less than two months, in an open and transparent manner. 4. If the Commission considers that the framework guideline does not contribute to non-discrimination, effective competition and the efficient functioning of the market, it may request the Agency to review the framework guideline within a reasonable period of time and re-submit it to the Commission. 5. If the Agency fails to submit or re-submit a framework guideline within the period set by the Commission under paragraphs 2 or 4, the Commission shall elaborate the framework guideline in question. 6. The Commission shall request the ENTSO for Gas to submit a network code which is in line with the relevant framework guideline, to the Agency within a reasonable period of time not exceeding 12 months. 7. Within a period of three months after the day of receipt of a network code, during which the Agency may formally consult the relevant stakeholders, the Agency shall provide a reasoned opinion to the ENTSO for Gas on the network code. 8. The ENTSO for Gas may amend the network code in the light of the opinion of the Agency and re-submit it to the Agency. 9. Once the Agency is satisfied that the network code is in line with the relevant framework guideline, the Agency shall submit the network code to the Commission and may recommend that it be adopted within a reasonable time period. The Commission shall provide reasons in the event that it does not adopt that network code. 10. Where the ENTSO for Gas has failed to develop a network code within the period of time set by the Commission under paragraph 6, the Commission may request the Agency to prepare a draft network code on the basis of the relevant framework guideline. The Agency may launch a further consultation in the course of preparing a draft network code under this paragraph. The Agency shall submit a draft network code prepared under this paragraph to the Commission and may recommend that it be adopted. 11. The Commission may adopt, on its own initiative where the ENTSO for Gas has failed to develop a network code, or the Agency has failed to develop a draft network code as referred to in paragraph 10 of this Article, or upon recommendation of the Agency under paragraph 9 of this Article, one or more network codes in the areas listed in Article 8(6). Where the Commission proposes to adopt a network code on its own initiative, the Commission shall consult the Agency, the ENTSO for Gas and all relevant stakeholders in regard to the draft network code during a period of no less than two months. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(2). 12. This Article shall be without prejudice to the Commission's right to adopt and amend the Guidelines as laid down in Article 23. Article 7 Amendments of network codes 1. Draft amendments to any network code adopted under Article 6 may be proposed to the Agency by persons who are likely to have an interest in that network code, including the ENTSO for Gas, transmission system operators, network users and consumers. The Agency may also propose amendments of its own initiative. 2. The Agency shall consult all stakeholders in accordance with Article 10 of Regulation (EC) No 713/2009. Following this process, the Agency may make reasoned proposals for amendments to the Commission, explaining how such proposals are consistent with the objectives of the network codes set out in Article 6(2) of this Regulation. 3. The Commission may adopt, taking account of the Agency's proposals, amendments to any network code adopted under Article 6. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(2). 4. Consideration of proposed amendments under the procedure set out in Article 28(2) shall be limited to consideration of the aspects related to the proposed amendment. Those proposed amendments are without prejudice to other amendments which the Commission may propose. Article 8 Tasks of the ENTSO for Gas 1. The ENTSO for Gas shall elaborate network codes in the areas referred to in paragraph 6 of this Article upon a request addressed to it by the Commission in accordance with Article 6(6). 2. The ENTSO for Gas may elaborate network codes in the areas set out in paragraph 6 with a view to achieving the objectives set out in Article 4 where those network codes do not relate to areas covered by a request addressed to it by the Commission. Those network codes shall be submitted to the Agency for an opinion. That opinion shall be duly taken into account by the ENTSO for Gas. 3. The ENTSO for Gas shall adopt: (a) common network operation tools to ensure coordination of network operation in normal and emergency conditions, including a common incidents classification scale, and research plans; (b) a non-binding Community-wide ten-year network development plan (Community-wide network development plan), including a European supply adequacy outlook, every two years; (c) recommendations relating to the coordination of technical cooperation between Community and third-country transmission system operators; (d) an annual work programme; (e) an annual report; (f) annual summer and winter supply outlooks. 4. The European supply adequacy outlook referred to in point (b) of paragraph 3 shall cover the overall adequacy of the gas system to supply current and projected demands for gas for the next five-year period as well as for the period between five and 10 years from the date of that outlook. The European supply adequacy outlook shall build on national supply outlooks prepared by each individual transmission system operator. 5. The annual work programme referred to in point (d) of paragraph 3 shall contain a list and description of the network codes to be prepared, a plan on coordination of operation of the network, and research and development activities, to be realised in that year, and an indicative calendar. 6. The network codes referred to in paragraphs 1 and 2 shall cover the following areas, taking into account, if appropriate, regional special characteristics: (a) network security and reliability rules; (b) network connection rules; (c) third-party access rules; (d) data exchange and settlement rules; (e) interoperability rules; (f) operational procedures in an emergency; (g) capacity-allocation and congestion-management rules; (h) rules for trading related to technical and operational provision of network access services and system balancing; (i) transparency rules; (j) balancing rules including network-related rules on nominations procedure, rules for imbalance charges and rules for operational balancing between transmission system operators' systems; (k) rules regarding harmonised transmission tariff structures; and (l) energy efficiency regarding gas networks. 7. The network codes shall be developed for cross-border network issues and market integration issues and shall be without prejudice to the Member States' right to establish national network codes which do not affect cross-border trade. 8. The ENTSO for Gas shall monitor and analyse the implementation of the network codes and the Guidelines adopted by the Commission in accordance with Article 6(11), and their effect on the harmonisation of applicable rules aimed at facilitating market integration. The ENTSO for Gas shall report its findings to the Agency and shall include the results of the analysis in the annual report referred to in point (e) of paragraph 3 of this Article. 9. The ENTSO for Gas shall make available all information required by the Agency to fulfil its tasks under Article 9(1). 10. The ENTSO for Gas shall adopt and publish a Community-wide network development plan referred to in point (b) of paragraph 3 every two years. The Community-wide network development plan shall include the modelling of the integrated network, scenario development, a European supply adequacy outlook and an assessment of the resilience of the system. The Community-wide network development plan shall, in particular: (a) build on national investment plans, taking into account regional investment plans as referred to in Article 12(1), and, if appropriate, Community aspects of network planning, including the guidelines for trans-European energy networks in accordance with Decision No 1364/2006/EC of the European Parliament and of the Council (9); (b) regarding cross-border interconnections, also build on the reasonable needs of different network users and integrate long-term commitments from investors referred to in Articles 14 and 22 of Directive 2009/73/EC; and (c) identify investment gaps, notably with respect to cross-border capacities. In regard to point (c) of the second subparagraph, a review of barriers to the increase of cross-border capacity of the network arising from different approval procedures or practices may be annexed to the Community-wide network development plan. 11. The Agency shall review national ten-year network development plans to assess their consistency with the Community-wide network development plan. If the Agency identifies inconsistencies between a national ten-year network development plan and the Community-wide network development plan, it shall recommend amending the national ten-year network development plan or the Community-wide network development plan as appropriate. If such national ten-year network development plan is elaborated in accordance with Article 22 of Directive 2009/73/EC, the Agency shall recommend that the competent national regulatory authority amend the national ten-year network development plan in accordance with Article 22(7) of that Directive and inform the Commission thereof. 12. Upon request of the Commission, the ENTSO for Gas shall give its views to the Commission on the adoption of the Guidelines as laid down in Article 23. Article 9 Monitoring by the Agency 1. The Agency shall monitor the execution of the tasks referred to in Article 8(1), (2) and (3) of the ENTSO for Gas and report to the Commission. The Agency shall monitor the implementation by the ENTSO for Gas of network codes elaborated under Article 8(2) and network codes which have been developed in accordance with Article 6(1) to (10) but which have not been adopted by the Commission under Article 6(11). Where the ENTSO for Gas has failed to implement such network codes, the Agency shall request the ENTSO for Gas to provide a duly reasoned explanation as to why it has failed to do so. The Agency shall inform the Commission of that explanation and provide its opinion thereon. The Agency shall monitor and analyse the implementation of the network codes and the Guidelines adopted by the Commission as laid down in Article 6(11), and their effect on the harmonisation of applicable rules aimed at facilitating market integration as well as on non-discrimination, effective competition and the efficient functioning of the market, and report to the Commission. 2. The ENTSO for Gas shall submit the draft Community-wide network development plan, the draft annual work programme, including the information regarding the consultation process and the other documents referred to in Article 8(3), to the Agency for its opinion. Within two months from the day of receipt, the Agency shall provide a duly reasoned opinion as well as recommendations to the ENTSO for Gas and to the Commission where it considers that the draft annual work programme or the draft Community-wide network development plan submitted by the ENTSO for Gas do not contribute to non-discrimination, effective competition, the efficient functioning of the market or a sufficient level of cross-border interconnection open to third-party access. Article 10 Consultations 1. While preparing the network codes, the draft Community-wide network development plan and the annual work programme referred to in Article 8(1), (2) and (3), the ENTSO for Gas shall conduct an extensive consultation process, at an early stage and in an open and transparent manner, involving all relevant market participants, and, in particular, the organisations representing all stakeholders, in accordance with the rules of procedure referred to in Article 5(1). That consultation shall also involve national regulatory authorities and other national authorities, supply and production undertakings, network users including customers, distribution system operators, including relevant industry associations, technical bodies and stakeholder platforms. It shall aim at identifying the views and proposals of all relevant parties during the decision-making process. 2. All documents and minutes of meetings related to the consultations referred to in paragraph 1 shall be made public. 3. Before adopting the annual work programme and the network codes referred to in Article 8(1), (2) and (3), the ENTSO for Gas shall indicate how the observations received during the consultation have been taken into consideration. It shall provide reasons where observations have not been taken into account. Article 11 Costs The costs related with the activities of the ENTSO for Gas referred to in Articles 4 to 12 shall be borne by the transmission system operators and shall be taken into account in the calculation of tariffs. Regulatory authorities shall approve those costs only if they are reasonable and proportionate. Article 12 Regional cooperation of transmission system operators 1. Transmission system operators shall establish regional cooperation within the ENTSO for Gas to contribute to the tasks referred to in Article 8(1), (2) and (3). In particular, they shall publish a regional investment plan every two years, and may take investment decisions based on that regional investment plan. 2. Transmission system operators shall promote operational arrangements in order to ensure the optimum management of the network and shall promote the development of energy exchanges, the coordinated allocation of cross-border capacity through non-discriminatory market-based solutions, paying due attention to the specific merits of implicit auctions for short-term allocations and the integration of balancing mechanisms. 3. For the purposes of achieving the goals set in paragraphs 1 and 2, the geographical area covered by each regional cooperation structure may be defined by the Commission, taking into account existing regional cooperation structures. Each Member State shall be allowed to promote cooperation in more than one geographical area. The measure referred to in the first sentence, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(2). For that purpose, the Commission shall consult the Agency and the ENTSO for Gas. Article 13 Tariffs for access to networks 1. Tariffs, or the methodologies used to calculate them, applied by the transmission system operators and approved by the regulatory authorities pursuant to Article 41(6) of Directive 2009/73/EC, as well as tariffs published pursuant to Article 32(1) of that Directive, shall be transparent, take into account the need for system integrity and its improvement and reflect the actual costs incurred, insofar as such costs correspond to those of an efficient and structurally comparable network operator and are transparent, whilst including an appropriate return on investments, and, where appropriate, taking account of the benchmarking of tariffs by the regulatory authorities. Tariffs, or the methodologies used to calculate them, shall be applied in a non-discriminatory manner. Member States may decide that tariffs may also be determined through market-based arrangements, such as auctions, provided that such arrangements and the revenues arising therefrom are approved by the regulatory authority. Tariffs, or the methodologies used to calculate them, shall facilitate efficient gas trade and competition, while at the same time avoiding cross-subsidies between network users and providing incentives for investment and maintaining or creating interoperability for transmission networks. Tariffs for network users shall be non-discriminatory and set separately for every entry point into or exit point out of the transmission system. Cost-allocation mechanisms and rate setting methodology regarding entry points and exit points shall be approved by the national regulatory authorities. By 3 September 2011, the Member States shall ensure that, after a transitional period, network charges shall not be calculated on the basis of contract paths. 2. Tariffs for network access shall neither restrict market liquidity nor distort trade across borders of different transmission systems. Where differences in tariff structures or balancing mechanisms would hamper trade across transmission systems, and notwithstanding Article 41(6) of Directive 2009/73/EC, transmission system operators shall, in close cooperation with the relevant national authorities, actively pursue convergence of tariff structures and charging principles, including in relation to balancing. Article 14 Third-party access services concerning transmission system operators 1. Transmission system operators shall: (a) ensure that they offer services on a non-discriminatory basis to all network users; (b) provide both firm and interruptible third-party access services. The price of interruptible capacity shall reflect the probability of interruption; (c) offer to network users both long and short-term services. In regard to point (a) of the first subparagraph, where a transmission system operator offers the same service to different customers, it shall do so under equivalent contractual terms and conditions, either using harmonised transport contracts or a common network code approved by the competent authority in accordance with the procedure laid down in Article 41 of Directive 2009/73/EC. 2. Transport contracts signed with non-standard start dates or with a shorter duration than a standard annual transport contract shall not result in arbitrarily higher or lower tariffs that do not reflect the market value of the service, in accordance with the principles laid down in Article 13(1). 3. Where appropriate, third-party access services may be granted subject to appropriate guarantees from network users with respect to the creditworthiness of such users. Such guarantees shall not constitute undue market-entry barriers and shall be non-discriminatory, transparent and proportionate. Article 15 Third-party access services concerning storage and LNG facilities 1. LNG and storage system operators shall: (a) offer services on a non-discriminatory basis to all network users that accommodate market demand; in particular, where an LNG or storage system operator offers the same service to different customers, it shall do so under equivalent contractual terms and conditions; (b) offer services that are compatible with the use of the interconnected gas transport systems and facilitate access through cooperation with the transmission system operator; and (c) make relevant information public, in particular data on the use and availability of services, in a time-frame compatible with the LNG or storage facility users' reasonable commercial needs, subject to the monitoring of such publication by the national regulatory authority. 2. Each storage system operator shall: (a) provide both firm and interruptible third-party access services; the price of interruptible capacity shall reflect the probability of interruption; (b) offer to storage facility users both long and short-term services; and (c) offer to storage facility users both bundled and unbundled services of storage space, injectability and deliverability. 3. LNG and storage facility contracts shall not result in arbitrarily higher tariffs in cases in which they are signed: (a) outside a natural gas year with non-standard start dates; or (b) with a shorter duration than a standard LNG and storage facility contract on an annual basis. 4. Where appropriate, third-party access services may be granted subject to appropriate guarantees from network users with respect to the creditworthiness of such users. Such guarantees shall not constitute undue market-entry barriers and shall be non-discriminatory, transparent and proportionate. 5. Contractual limits on the required minimum size of LNG facility capacity and storage capacity shall be justified on the basis of technical constrains and shall permit smaller storage users to gain access to storage services. Article 16 Principles of capacity-allocation mechanisms and congestion-management procedures concerning transmission system operators 1. The maximum capacity at all relevant points referred to in Article 18(3) shall be made available to market participants, taking into account system integrity and efficient network operation. 2. The transmission system operator shall implement and publish non-discriminatory and transparent capacity-allocation mechanisms, which shall: (a) provide appropriate economic signals for the efficient and maximum use of technical capacity, facilitate investment in new infrastructure and facilitate cross-border exchanges in natural gas; (b) be compatible with the market mechanisms including spot markets and trading hubs, while being flexible and capable of adapting to evolving market circumstances; and (c) be compatible with the network access systems of the Member States. 3. The transmission system operator shall implement and publish non-discriminatory and transparent congestion-management procedures which facilitate cross-border exchanges in natural gas on a non-discriminatory basis and which shall be based on the following principles: (a) in the event of contractual congestion, the transmission system operator shall offer unused capacity on the primary market at least on a day-ahead and interruptible basis; and (b) network users who wish to re-sell or sublet their unused contracted capacity on the secondary market shall be entitled to do so. In regard to point (b) of the first subparagraph, a Member State may require notification or information of the transmission system operator by network users. 4. In the event that physical congestion exists, non-discriminatory, transparent capacity-allocation mechanisms shall be applied by the transmission system operator or, as appropriate, by the regulatory authorities. 5. Transmission system operators shall regularly assess market demand for new investment. When planning new investments, transmission system operators shall assess market demand and take into account security of supply. Article 17 Principles of capacity-allocation mechanisms and congestion-management procedures concerning storage and LNG facilities 1. The maximum storage and LNG facility capacity shall be made available to market participants, taking into account system integrity and operation. 2. LNG and storage system operators shall implement and publish non-discriminatory and transparent capacity-allocation mechanisms which shall: (a) provide appropriate economic signals for the efficient and maximum use of capacity and facilitate investment in new infrastructure; (b) be compatible with the market mechanism including spot markets and trading hubs, while being flexible and capable of adapting to evolving market circumstances; and (c) be compatible with the connected network access systems. 3. LNG and storage facility contracts shall include measures to prevent capacity-hoarding, by taking into account the following principles, which shall apply in cases of contractual congestion: (a) the system operator must offer unused LNG facility and storage capacity on the primary market without delay; for storage facilities this must be at least on a day-ahead and interruptible basis; (b) LNG and storage facility users who wish to re-sell their contracted capacity on the secondary market must be entitled to do so. Article 18 Transparency requirements concerning transmission system operators 1. The transmission system operator shall make public detailed information regarding the services it offers and the relevant conditions applied, together with the technical information necessary for network users to gain effective network access. 2. In order to ensure transparent, objective and non-discriminatory tariffs and facilitate efficient utilisation of the gas network, transmission system operators or relevant national authorities shall publish reasonably and sufficiently detailed information on tariff derivation, methodology and structure. 3. For the services provided, each transmission system operator shall make public information on technical, contracted and available capacities on a numerical basis for all relevant points including entry and exit points on a regular and rolling basis and in a user-friendly and standardised manner. 4. The relevant points of a transmission system on which the information is to be made public shall be approved by the competent authorities after consultation with network users. 5. The transmission system operator shall always disclose the information required by this Regulation in a meaningful, quantifiably clear and easily accessible manner and on a non-discriminatory basis. 6. The transmission system operator shall make public ex-ante and ex-post supply and demand information, based on nominations, forecasts and realised flows in and out of the system. The national regulatory authority shall ensure that all such information is made public. The level of detail of the information that is made public shall reflect the information available to the transmission system operator. The transmission system operator shall make public measures taken as well as costs incurred and revenue generated to balance the system. The market participants concerned shall provide the transmission system operator with the data referred to in this Article. Article 19 Transparency requirements concerning storage facilities and LNG facilities 1. LNG and storage system operators shall make public detailed information regarding the services it offers and the relevant conditions applied, together with the technical information necessary for LNG and storage facility users to gain effective access to the LNG and storage facilities. 2. For the services provided, LNG and storage system operators shall make public information on contracted and available storage and LNG facility capacities on a numerical basis on a regular and rolling basis and in a user-friendly standardised manner. 3. LNG and storage system operators shall always disclose the information required by this Regulation in a meaningful, quantifiably clear and easily accessible way and on a non-discriminatory basis. 4. LNG and storage system operators shall make public the amount of gas in each storage or LNG facility, or group of storage facilities if that corresponds to the way in which the access is offered to system users, inflows and outflows, and the available storage and LNG facility capacities, including for those facilities exempted from third-party access. That information shall also be communicated to the transmission system operator, which shall make it public on an aggregated level per system or subsystem defined by the relevant points. The information shall be updated at least daily. In cases in which a storage system user is the only user of a storage facility, the storage system user may submit to the national regulatory authority a reasoned request for confidential treatment of the data referred to in the first subparagraph. Where the national regulatory authority comes to the conclusion that such a request is justified, taking into account, in particular, the need to balance the interest of legitimate protection of business secrets, the disclosure of which would negatively affect the overall commercial strategy of the storage user, with the objective of creating a competitive internal gas market, it may allow the storage system operator not to make public the data referred to in the first subparagraph, for a duration of up to one year. The second subparagraph shall apply without prejudice to the obligations of communication to and publication by the transmission system operator referred to in the first subparagraph, unless the aggregated data are identical to the individual storage system data for which the national regulatory authority has approved non-publication. 5. In order to ensure transparent, objective and non-discriminatory tariffs and facilitate efficient utilisation of the infrastructures, the LNG and storage facility operators or relevant regulatory authorities shall make public sufficiently detailed information on tariff derivation, the methodologies and the structure of tariffs for infrastructure under regulated third-party access. Article 20 Record keeping by system operators Transmission system operators, storage system operators and LNG system operators shall keep at the disposal of the national authorities, including the national regulatory authority, the national competition authority and the Commission, all information referred to in Articles 18 and 19, and in Part 3 of Annex I for a period of five years. Article 21 Balancing rules and imbalance charges 1. Balancing rules shall be designed in a fair, non-discriminatory and transparent manner and shall be based on objective criteria. Balancing rules shall reflect genuine system needs taking into account the resources available to the transmission system operator. Balancing rules shall be market-based. 2. In order to enable network users to take timely corrective action, the transmission system operator shall provide sufficient, well-timed and reliable on-line based information on the balancing status of network users. The information provided shall reflect the level of information available to the transmission system operator and the settlement period for which imbalance charges are calculated. No charge shall be made for the provision of information under this paragraph. 3. Imbalance charges shall be cost-reflective to the extent possible, whilst providing appropriate incentives on network users to balance their input and off-take of gas. They shall avoid cross-subsidisation between network users and shall not hamper the entry of new market entrants. Any calculation methodology for imbalance charges as well as the final tariffs shall be made public by the competent authorities or the transmission system operator, as appropriate. 4. Member States shall ensure that transmission system operators endeavour to harmonise balancing regimes and streamline structures and levels of balancing charges in order to facilitate gas trade. Article 22 Trading of capacity rights Each transmission, storage and LNG system operator shall take reasonable steps to allow capacity rights to be freely tradable and to facilitate such trade in a transparent and non-discriminatory manner. Every such operator shall develop harmonised transport, LNG facility and storage contracts and procedures on the primary market to facilitate secondary trade of capacity and shall recognise the transfer of primary capacity rights where notified by system users. The harmonised transport, LNG facility and storage contracts and procedures shall be notified to the regulatory authorities. Article 23 Guidelines 1. Where appropriate, Guidelines providing the minimum degree of harmonisation required to achieve the aims of this Regulation shall specify: (a) details of third-party access services, including the character, duration and other requirements of those services, in accordance with Articles 14 and 15; (b) details of the principles underlying capacity-allocation mechanisms and on the application of congestion-management procedures in the event of contractual congestion, in accordance with Articles 16 and 17; (c) details of the provision of information, definition of the technical information necessary for network users to gain effective access to the system and the definition of all relevant points for transparency requirements, including the information to be published at all relevant points and the time schedule for the publication of that information, in accordance with Articles 18 and 19; (d) details of tariff methodology related to cross-border trade of natural gas, in accordance with Article 13; (e) details relating to the areas listed in Article 8(6). For that purpose, the Commission shall consult the Agency and the ENTSO for Gas. 2. Guidelines on the issues listed in points (a), (b) and (c) of paragraph 1 are laid down in Annex I with respect to transmission system operators. The Commission may adopt Guidelines on the issues listed in paragraph 1 of this Article and amend the Guidelines referred to in points (a), (b) and (c) thereof. Those measures, designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(2). 3. The application and amendment of Guidelines adopted pursuant to this Regulation shall reflect differences between national gas systems, and shall, therefore, not require uniform detailed terms and conditions of third-party access at Community level. They may, however, set minimum requirements to be met to achieve non-discriminatory and transparent network access conditions necessary for an internal market in natural gas, which may then be applied in the light of differences between national gas systems. Article 24 Regulatory authorities When carrying out their responsibilities under this Regulation, the regulatory authorities shall ensure compliance with this Regulation and the Guidelines adopted pursuant to Article 23. Where appropriate, they shall cooperate with each other, with the Commission and the Agency in compliance with Chapter VIII of Directive 2009/73/EC. Article 25 Provision of information Member States and the regulatory authorities shall, on request, provide to the Commission all information necessary for the purposes of Article 23. The Commission shall set a reasonable time limit within which the information is to be provided, taking into account the complexity of the information required and the urgency with which the information is needed. Article 26 Right of Member States to provide for more detailed measures This Regulation shall be without prejudice to the rights of Member States to maintain or introduce measures that contain more detailed provisions than those set out herein or in the Guidelines referred to in Article 23. Article 27 Penalties 1. The Member States shall lay down rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that those provisions are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify the Commission by 1 July 2006 of those rules corresponding to the provisions laid down in Regulation (EC) No 1775/2005 and shall notify the Commission without delay of any subsequent amendment affecting them. They shall notify the Commission of those rules not corresponding to the provisions laid down in Regulation (EC) No 1775/2005 by 3 September 2009 and shall notify the Commission without delay of any subsequent amendment affecting them. 2. Penalties provided for pursuant to paragraph 1 shall not be of a criminal law nature. Article 28 Committee procedure 1. The Commission shall be assisted by the committee set up by Article 51 of Directive 2009/73/EC. 2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Article 29 Commission report The Commission shall monitor the implementation of this Regulation. In its report under Article 52(6) of Directive 2009/73/EC, the Commission shall also report on the experience gained in the application of this Regulation. In particular, the report shall examine to what extent this Regulation has been successful in ensuring non-discriminatory and cost-reflective network access conditions for gas transmission networks in order to contribute to customer choice in a well-functioning internal market and to long-term security of supply. If necessary, the report shall be accompanied by appropriate proposals and/or recommendations. Article 30 Derogations and exemptions This Regulation shall not apply to: (a) natural gas transmission systems situated in Member States for the duration of derogations granted under Article 49 of Directive 2009/73/EC; (b) major new infrastructure, i.e. interconnectors, LNG and storage facilities, and significant increases of capacity in existing infrastructure and modifications of such infrastructure which enable the development of new sources of gas supply referred to in Article 36(1) and (2) of Directive 2009/73/EC which are exempt from the provisions of Articles 9, 14, 32, 33, 34 or Article 41(6), (8) and (10) of that Directive as long as they are exempt from the provisions referred to in this subparagraph, with the exception of Article 19(4) of this Regulation; or (c) natural gas transmission systems which have been granted derogations under Article 48 of Directive 2009/73/EC. As regards point (a) of the first subparagraph, Member States that have been granted derogations under Article 49 of Directive 2009/73/EC may apply to the Commission for a temporary derogation from the application of this Regulation, for a period of up to two years from the date on which the derogation referred to in that point expires. Article 31 Repeal Regulation (EC) No 1775/2005 shall be repealed from 3 March 2011. References made to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex II. Article 32 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 3 September 2009. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 13 July 2009. For the European Parliament The President H.-G. PÖTTERING For the Council The President E. ERLANDSSON (1) OJ C 211, 19.8.2008, p. 23. (2) OJ C 172, 5.7.2008, p. 55. (3) Opinion of the European Parliament of 9 July 2008 (not yet published in the Official Journal), Council Common Position of 9 January 2009 (OJ C 75 E, 31.3.2009, p. 38) and Position of the European Parliament of 22 April 2009 (not yet published in the Official Journal). Council Decision of 25 June 2009. (4) OJ L 176, 15.7.2003, p. 57. (5) OJ L 289, 3.11.2005, p. 1. (6) See page 94 of this Official Journal. (7) See page 1 of this Official Journal. (8) OJ L 184, 17.7.1999, p. 23. (9) OJ L 262, 22.9.2006, p. 1. ANNEX I GUIDELINES ON 1. Third-party access services concerning transmission system operators 1. Transmission system operators shall offer firm and interruptible services down to a minimum period of one day. 2. Harmonised transport contracts and common network codes shall be designed in a manner that facilitates trading and re-utilisation of capacity contracted by network users without hampering capacity release. 3. Transmission system operators shall develop network codes and harmonised contracts following proper consultation with network users. 4. Transmission system operators shall implement standardised nomination and re-nomination procedures. They shall develop information systems and electronic communication means to provide adequate data to network users and to simplify transactions, such as nominations, capacity contracting and transfer of capacity rights between network users. 5. Transmission system operators shall harmonise formalised request procedures and response times according to best industry practice with the aim of minimising response times. They shall provide for online screen-based capacity booking and confirmation systems and nomination and re-nomination procedures no later than 1 July 2006 after consultation with the relevant network users. 6. Transmission system operators shall not separately charge network users for information requests and transactions associated with their transport contracts and which are carried out according to standard rules and procedures. 7. Information requests that require extraordinary or excessive expenses such as feasibility studies may be charged separately, provided the charges can be duly substantiated. 8. Transmission system operators shall cooperate with other transmission system operators in coordinating the maintenance of their respective networks in order to minimise any disruption of transmission services to network users and transmission system operators in other areas and in order to ensure equal benefits with respect to security of supply including in relation to transit. 9. Transmission system operators shall publish at least annually, by a predetermined deadline, all planned maintenance periods that might affect network users' rights from transport contracts and corresponding operational information with adequate advance notice. This shall include publishing on a prompt and non-discriminatory basis any changes to planned maintenance periods and notification of unplanned maintenance, as soon as that information becomes available to the transmission system operator. During maintenance periods, transmission system operators shall publish regularly updated information on the details of and expected duration and effect of the maintenance. 10. Transmission system operators shall maintain and make available to the competent authority upon request a daily log of the actual maintenance and flow disruptions that have occurred. Information shall also be made available on request to those affected by any disruption. 2. Principles of capacity-allocation mechanisms and congestion-management procedures concerning transmission system operators and their application in the event of contractual congestion 2.1. Principles of capacity-allocation mechanisms and congestion-management procedures concerning transmission system operators 1. Capacity-allocation mechanisms and congestion-management procedures shall facilitate the development of competition and liquid trading of capacity and shall be compatible with market mechanisms including spot markets and trading hubs. They shall be flexible and capable of adapting to evolving market circumstances. 2. Those mechanisms and procedures shall take into account the integrity of the system concerned as well as security of supply. 3. Those mechanisms and procedures shall neither hamper the entry of new market participants nor create undue barriers to market entry. They shall not prevent market participants, including new market entrants and companies with a small market share, from competing effectively. 4. Those mechanisms and procedures shall provide appropriate economic signals for efficient and maximum use of technical capacity and facilitate investment in new infrastructure. 5. Network users shall be advised about the type of circumstance that could affect the availability of contracted capacity. Information on interruption should reflect the level of information available to the transmission system operator. 6. Should difficulties in meeting contractual delivery obligations arise due to system integrity reasons, transmission system operators should notify network users and seek a non-discriminatory solution without delay. Transmission system operators shall consult network users regarding procedures prior to their implementation and agree them with the regulatory authority. 2.2. Congestion-management procedures in the event of contractual congestion 1. In the event that contracted capacity goes unused, transmission system operators shall make that capacity available on the primary market on an interruptible basis via contracts of differing duration, as long as that capacity is not offered by the relevant network user on the secondary market at a reasonable price. 2. Revenues from released interruptible capacity shall be split according to rules laid down or approved by the relevant regulatory authority. Those rules shall be compatible with the requirement of an effective and efficient use of the system. 3. A reasonable price for released interruptible capacity may be determined by the relevant regulatory authorities taking into account the specific circumstances prevailing. 4. Where appropriate, transmission system operators shall make reasonable endeavours to offer at least parts of the unused capacity to the market as firm capacity. 3. Definition of the technical information necessary for network users to gain effective access to the system, the definition of all relevant points for transparency requirements and the information to be published at all relevant points and the time schedule according to which that information shall be published 3.1. Definition of the technical information necessary for network users to gain effective access to the system Transmission system operators shall publish at least the following information about their systems and services: (a) a detailed and comprehensive description of the different services offered and their charges; (b) the different types of transport contracts available for those services and, as applicable, the network code and/or the standard conditions outlining the rights and responsibilities of all network users including harmonised transport contracts and other relevant documents; (c) the harmonised procedures applied when using the transmission system, including the definition of key terms; (d) provisions on capacity allocation, congestion management, and anti-hoarding and re-utilisation procedures; (e) the rules applicable to capacity trade on the secondary market as regards the transmission system operator; (f) if applicable, the flexibility and tolerance levels included in transport and other services without separate charge, as well as any flexibility offered in addition thereto and the corresponding charges; (g) a detailed description of the gas system of the transmission system operator indicating all relevant points interconnecting its system with that of other transmission system operators and/or gas infrastructure such as liquefied natural gas (LNG) and infrastructure necessary for providing ancillary services as defined by Article 2 point 14 of Directive 2009/73/EC; (h) information on gas quality and pressure requirements; (i) the rules applicable for connection to the system operated by the transmission system operator; (j) any information, in a timely manner, as regards proposed and/or actual changes to the services or conditions, including the items listed in points (a) to (i). 3.2. Definition of all relevant points for transparency requirements Relevant points shall include at least: (a) all entry points to a network operated by a transmission system operator; (b) the most important exit points and exit zones covering at least 50 % of total exit capacity of the network of a given transmission system operator, including all exit points or exit zones covering more than 2 % of total exit capacity of the network; (c) all points connecting different networks of transmission system operators; (d) all points connecting the network of a transmission system operator with an LNG terminal; (e) all essential points within the network of a given transmission system operator including points connecting to gas hubs. All points are considered essential which, based on experience, are likely to experience physical congestion; (f) all points connecting the network of a given transmission system operator to infrastructure necessary for providing ancillary services as defined by Article 2, point 14 of Directive 2009/73/EC. 3.3. Information to be published at all relevant points and the time schedule according to which that information should be published 1. At all relevant points, transmission system operators shall publish the following information about the capacity situation down to daily periods on the Internet on a regular/rolling basis and in a user-friendly standardised manner: (a) the maximum technical capacity for flows in both directions; (b) the total contracted and interruptible capacity; and (c) the available capacity. 2. For all relevant points, transmission system operators shall publish available capacities for a period of at least 18 months ahead and shall update that information at least every month or more frequently, if new information becomes available. 3. Transmission system operators shall publish daily updates of availability of short-term services (day-ahead and week-ahead) based, inter alia, on nominations, prevailing contractual commitments and regular long-term forecasts of available capacities on an annual basis for up to ten years for all relevant points. 4. Transmission system operators shall publish historical maximum and minimum monthly capacity utilisation rates and annual average flows at all relevant points for the past three years on a rolling basis. 5. Transmission system operators shall keep a daily log of actual aggregated flows for at least three months. 6. Transmission system operators shall keep effective records of all capacity contracts and all other relevant information in relation to calculating and providing access to available capacities, to which relevant national authorities shall have access to fulfil their duties. 7. Transmission system operators shall provide user-friendly instruments for calculating tariffs for the services available and for verifying on-line the capacity available. 8. Where transmission system operators are unable to publish information in accordance with points 1, 3 and 7, they shall consult their relevant national authorities and set up an action plan for implementation as soon as possible, but no later than 31 December 2006. ANNEX II CORRELATION TABLE Regulation (EC) No 1775/2005 This Regulation Article 1 Article 1 Article 2 Article 2 — Article 3 — Article 4 — Article 5 — Article 6 — Article 7 — Article 8 — Article 9 — Article 10 — Article 11 — Article 12 Article 3 Article 13 Article 4 Article 14 — Article 15 Article 5 Article 16 — Article 17 Article 6 Article 18 — Article 19 — Article 20 Article 7 Article 21 Article 8 Article 22 Article 9 Article 23 Article 10 Article 24 Article 11 Article 25 Article 12 Article 26 Article 13 Article 27 Article 14 Article 28 Article 15 Article 29 Article 16 Article 30 — Article 31 Article 17 Article 32 Annex Annex I

Natural gas transmission networks Natural gas transmission networks SUMMARY OF: Regulation (EC) No 715/2009 on conditions for access to the natural gas transmission networks WHAT IS THE AIM OF THE REGULATION? It lays down rules for access to: natural gas transmission* networks; gas storage; and liquefied natural gas facilities. These rules aim to counteract barriers to competition in the EU’s market for natural gas and to ensure its smooth operation. KEY POINTS The regulation determines: how tariffs (solely for access to networks) are set; the services to be offered; the allocation of capacity to gas transmission system operators (TSOs)*; transparency requirements (such as rules on publishing how they arrive at their tariffs and their tariff structure); and balancing* rules and imbalance charges on the market. Certification of transmission system operators National regulatory authorities (NRAs) must notify the European Commission of decisions relating to certifying a TSO. The Commission has 2 months to deliver its opinion to an NRA . The authority then adopts the final decision concerning the TSO’s certification. This decision and the Commission’s opinion are published. Creation of the European Network of Transmission System Operators for Gas (ENTSOG) The gas TSOs had to submit to the Commission and to the Agency for the Cooperation of Energy Regulators (ACER) the draft statutes for the ENTSOG, a list of members and draft rules of procedure by 3 March 2011. Tasks of the ENTSOG concerning network codes The Commission must consult ACER and the ENTSOG in order to establish an annual list of the priorities for developing sets of rules (known as network codes). These codes are developed using a non-binding guideline submitted to the Commission by ACER. The codes relate in particular to: capacity allocation and congestion management rules; interoperability rules between transmission system operators; balancing rules; transparency of rules; harmonised transmission tariff structures. Tasks of the ENTSOG The ENTSOG is responsible for adopting: common network operation tools; a 10-year network development plan; recommendations for coordinated technical cooperation between EU TSOs; an annual work programme; an annual report; annual summer and winter supply outlooks. Costs and tariffs The regulatory authorities determine tariffs or methodologies for their calculation. EU countries may take decisions relating to tariffs such as fixing auction arrangements. Third-party access services TSOs must offer their services in a non-discriminatory manner to all network users.Detailed allocation rules are established in the Network Code on Capacity Allocation Mechanism. Liquefied natural gas and storage facility operators must also offer their services on a non-discriminatory basis and make them compatible with the use of interconnected gas transport networks. EU countries may decide whether access for storage is to be regulated or negotiated. Congestion management All market participants must have access to maximum network capacity as well as to storage and LNG facilities. TSOs must practise and publish transparent congestion-management* procedures which ensure that cross-border exchanges in gas are on a non-discriminatory basis. FROM WHEN DOES THE REGULATION APPLY? It has applied since 3 March 2011. It repealed Regulation (EC) No 1775/2005 from 3 March 2011. BACKGROUND For more information, see: Market legislation (European Commission) European Network of Transmission System Operators for Gas — ENTSOG (European Commission). KEY TERMS Transmission: transport of gas from production areas to end consumers by underground pipelines. Transmission system operator (TSO): a body that transports energy, such as natural gas, either nationally or regionally, using fixed infrastructure. Balancing: making receipts and deliveries of gas into or withdrawals from a company equal. Balancing may be accomplished daily, monthly or seasonally, with penalties generally assessed for excessive imbalance. Congestion management: congestion arises when the transmission system is not sufficient to transfer the power according to market desires. Congestion management ensures the use of the power available without violating the system constraints. MAIN DOCUMENT Regulation (EC) No 715/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the natural gas transmission networks and repealing Regulation (EC) No 1775/2005 (OJ L 211, 14.8.2009, pp. 36-54) Successive amendments to Implementing Regulation (EC) No 715/2009) have been incorporated in the original text. This consolidated version is of documentary value only. RELATED ACTS Commission Regulation (EU) 2017/459 of 16 March 2017 establishing a network code on capacity allocation mechanisms in gas transmission systems and repealing Regulation (EU) No 984/2013 (OJ L 72, 17.3.2017, pp. 1-28) Commission Regulation (EU) 2017/460 of 16 March 2017 establishing a network code on harmonised transmission tariff structures for gas (OJ L 72, 17.3.2017, pp. 29-56) Commission Regulation (EU) 2015/703 of 30 April 2015 establishing a network code on interoperability and data exchange rules (OJ L 113, 1.5.2015, pp. 13-26) Commission Regulation (EU) No 312/2014 of 26 March 2014 establishing a Network Code on Gas Balancing of Transmission Networks (OJ L 91, 27.3.2014, pp. 15-35) last update 05.07.2018

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25.6.2019 EN Official Journal of the European Union L 169/45 REGULATION (EU) 2019/1021 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on persistent organic pollutants (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Regulation (EC) No 850/2004 of the European Parliament and of the Council (3) has been substantially amended several times. Since it is necessary to make further amendments, that Regulation should be recast in the interests of clarity. (2) The Union is seriously concerned by the continuous release of persistent organic pollutants (‘POPs’) into the environment. Those chemical substances are transported across international boundaries, far from their sources, and they persist in the environment, bioaccumulate through the food web, and pose a risk to human health and the environment. Therefore, further measures need to be taken in order to protect human health and the environment against those pollutants. (3) In view of its responsibilities for the protection of the environment, the Union approved on 19 February 2004 the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants (4) (‘the Protocol’) and approved on 14 October 2004 the Stockholm Convention on Persistent Organic Pollutants (5) (‘the Convention’). (4) In order to ensure coherent and effective implementation of the Union's obligations under the Protocol and the Convention, it is necessary to establish a common legal framework within which to take measures designed, in particular, to eliminate the manufacturing, placing on the market and use of intentionally manufactured POPs. Furthermore, POPs' characteristics should be taken into consideration in the framework of the relevant Union assessment and authorisation schemes. (5) When implementing the provisions of the Convention at Union level, it is necessary to ensure coordination and coherence with the provisions of the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade, which was approved by the Union on 19 December 2002 (6), and with the provisions of the Basel Convention on the control of transboundary movements of hazardous wastes and their disposal, which was approved by the Union on 1 February 1993 (7) and of the Minamata Convention on Mercury, which was approved by the Union on 11 May 2017 (8). This coordination and coherence should also be maintained when participating in the implementation and further development of the Strategic Approach to International Chemicals Management (SAICM), adopted by the First International Conference on Chemicals Management in Dubai on 6 February 2006, and the Sound Management of Chemicals and Waste Beyond 2020 within the United Nations framework. (6) Moreover, considering that the provisions of this Regulation are underpinned by the precautionary principle as set forth in the Treaty on the Functioning of the European Union (TFEU), and mindful of the precautionary approach to environmental protection as set forth in Principle 15 of the Rio Declaration on Environment and Development, and in view of the aim of the elimination, where feasible, of the release of POPs into the environment, it is appropriate in certain cases to provide for control measures stricter than those under the Protocol and the Convention. (7) In the Union, the placing on the market and use of most of the POPs listed in the Protocol or the Convention have already been phased out as a result of the prohibitions laid down in, inter alia, Regulations (EC) No 1907/2006 (9), (EC) No 1107/2009 (10) and (EU) No 528/2012 (11) of the European Parliament and of the Council. However, in order to fulfil the Union's obligations under the Protocol and the Convention, and to minimise the release of POPs, it is necessary and appropriate also to prohibit the manufacturing of those substances and to restrict exemptions to a minimum so that exemptions only apply where a substance fulfils an essential function in a specific application. (8) For reasons of clarity and consistency with other relevant Union legislative acts, certain definitions should be specified, and terminology should be aligned with that used in Regulation (EC) No 1907/2006 and Directive 2008/98/EC of the European Parliament and of the Council (12). (9) Exports of substances covered by the Convention are regulated by Regulation (EU) No 649/2012 of the European Parliament and of the Council (13) and therefore need not be further addressed in this Regulation. (10) Obsolete or carelessly managed stockpiles of POPs may seriously endanger the environment and human health through, for instance, contamination of soil and ground water. It is appropriate, therefore, to lay down stricter rules concerning the management of such stockpiles compared to those laid down in the Convention. Stockpiles of prohibited substances should be treated as waste, while stockpiles of substances the manufacturing or use of which is still allowed should be notified to the authorities and properly supervised. In particular, existing stockpiles which consist of or contain banned POPs should be managed as waste as soon as possible. If other substances are banned in the future, their stocks should also be destroyed without delay, and no new stockpiles should be built up. (11) In line with the Protocol and the Convention, releases of POPs which are unintentional by-products of industrial processes should be identified and reduced as soon as possible, with the ultimate aim of elimination, where feasible. Appropriate national action plans, covering all sources and measures, including those provided for under existing Union legislation, should be developed, updated and implemented, as appropriate, as soon as possible, to reduce such releases continuously and cost-effectively. To this end, appropriate tools should be developed in the framework of the Convention. (12) The Guidelines on Best Available Techniques and Provisional Guidance on Best Environmental Practices Relevant to Article 5 and Annex C of the Stockholm Convention on Persistent Organic Pollutants, which were adopted pursuant to the Stockholm Convention, should be used when considering proposals to construct new facilities or to significantly modify existing facilities using processes that release chemicals listed in Annex III to this Regulation. (13) Appropriate programmes and mechanisms should be established or maintained, as appropriate, to provide adequate monitoring data on the presence of substances listed in Part A of Annex III in the environment. However, it is necessary to ensure that appropriate tools are available and can be used under economically and technically viable conditions. (14) Under the Convention, the POP content in waste is to be destroyed or irreversibly transformed into substances that do not exhibit similar characteristics, unless other operations are environmentally preferable. In order for the Union to comply with its obligations under the Convention, it is necessary to lay down specific rules as regards those substances. To ensure a high level of protection, common concentration limits for the substances in waste should be established, monitored and enforced. (15) Concerning polybrominated diphenyl ethers (PBDEs) listed in this Regulation, including decaBDE, the concentration limit for the sum of those substances in waste is set at 1 000 mg/kg. Considering that scientific and technical progress are rapidly evolving, the Commission should review that concentration limit and, where appropriate, adopt a legislative proposal to lower that value to 500 mg/kg. The Commission should act as quickly as possible and, in any event, not later than 16 July 2021. (16) It is important to identify and separate waste consisting of, containing or contaminated by POPs at source in order to minimise the spread of those chemicals into other waste. Directive 2008/98/EC establishes Union rules on the management of hazardous waste, obliging Member States to take the necessary measures to require that establishments and undertakings which dispose of, recover, collect or transport hazardous waste, do not mix different categories of hazardous waste or mix hazardous waste with non-hazardous waste. (17) In order to promote the traceability of waste containing POPs and ensure control, the provisions of the record keeping system established in accordance with Article 17 of Directive 2008/98/EC should apply also to such waste containing POPs which is not defined as hazardous waste according to Commission Decision 2014/955/EU (14). (18) There is a need to ensure the effective coordination and management of technical and administrative aspects of this Regulation at Union level. The European Chemicals Agency (‘the Agency’), established by Regulation (EC) No 1907/2006, has the competence and experience in implementing Union legislation on chemicals and international agreements on chemicals. The Member States and the Agency should therefore carry out tasks with regard to the administrative, technical and scientific aspects of the implementation of this Regulation and the exchange of information. The role of the Agency should include the preparation and examination of technical dossiers, including stakeholder consultations, and the drawing up of opinions that should be used by the Commission in considering whether to come forward with a proposal for listing a substance as a POP in the Convention or the Protocol. In addition, the Commission, the Member States and the Agency should cooperate in order to implement the Union's international obligations under the Convention effectively. (19) The Convention provides that each Party is to draw up, update and endeavour to implement, as appropriate, a plan for the implementation of its obligations under the Convention. Member States should provide opportunities for public participation in drawing up, implementing and updating their implementation plans. Since the Union and the Member States share competence in that regard, implementation plans should be drawn up and updated both at national and Union level. Cooperation and exchange of information, including on sites contaminated by POPs, between the Commission, the Agency and the authorities of the Member States should be promoted. (20) Substances listed in Part A of Annex I or Part A of Annex II to this Regulation should only be allowed to be manufactured and used as closed-system site-limited intermediates if an annotation to that effect is expressly entered in the relevant Annex and if the manufacturer demonstrates to the Member State concerned that the substance is only manufactured and used under strictly controlled conditions. (21) In accordance with the Convention and the Protocol, information on POPs should be provided to other Parties to those Agreements. The exchange of information with third countries not party to those Agreements should also be promoted. (22) Since public awareness of the hazards that POPs pose to the health of present and future generations, as well as to the environment, particularly in developing countries, is often lacking, wide-scale information is needed to increase the level of caution and public understanding of the rationale for restrictions and bans. In accordance with the Convention, public awareness programmes on those substances as regards their health and environmental effects, especially for the most vulnerable groups, as well as training of workers, scientists, educators, technical and managerial personnel should be promoted and facilitated, as appropriate. The Union should ensure access to information, without prejudice to Regulations (EC) No 1049/2001 (15) and (EC) No 1367/2006 (16) of the European Parliament and of the Council, and to Directive 2003/4/EC of the European Parliament and of the Council (17). (23) In order to promote the development of a comprehensive chemical exposure and toxicity knowledge base, in line with the General Union Environment Action Programme to 2020 ‘Living well, within the limits of our planet’ (‘the 7th EAP’) (18), the Commission has established the Information Platform for Chemical Monitoring. The use of that platform should be encouraged as a means for Member States to comply with their obligations to report chemical occurrence data and to simplify and reduce their reporting obligations. (24) Upon request, and within available resources, the Commission, the Agency and the Member States should cooperate in providing appropriate and timely technical assistance designed especially to strengthen the capacity of developing countries and countries with economies in transition to implement the Convention. Technical assistance should include the development and implementation of suitable alternative products, methods and strategies, under the Convention, to ensure that POPs only continue to be used when locally safe, effective and affordable alternatives are not available to the country in question. (25) There should be regular evaluation of the effectiveness of measures taken to reduce releases of POPs. To that end, Member States should report regularly, in standardised form, to the Agency, in particular as regards release inventories, notified stockpiles and the manufacturing and placing on the market of restricted substances. (26) To address the need for information on implementation and compliance, an alternative system of collecting and making information available should be introduced, taking into account the results of the Commission Report on Actions to Streamline Environmental Reporting and its related Fitness Check. In particular, Member States should make all relevant data accessible. That should ensure that the administrative burden on all entities remains as limited as possible. It requires that active dissemination at national level be done in accordance with Directives 2003/4/EC and 2007/2/EC of the European Parliament and of the Council (19), to ensure the appropriate infrastructure for public access, reporting and data-sharing between public authorities. In that context, Member States and the Agency should base the specifications for spatial data on the implementing acts adopted under Directive 2007/2/EC. (27) The Convention and the Protocol provide that Parties thereto may propose additional substances for international action and consequently additional substances may be listed under those Agreements. In such cases, this Regulation should be amended accordingly. (28) In order to amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending this Regulation by permitting, where appropriate, the manufacture and use of a substance listed in Part A of Annex I or Part A of Annex II to this Regulation as a closed-system site-limited intermediate and amending the deadlines in an annotation entered in the relevant Annex for that purpose, of amending Annex III to this Regulation in order to move a substance from Part B to Part A thereof and of amending Annexes I, II and III to this Regulation in order to adapt them to any change to the list of substances set out in the Annexes to the Convention or the Protocol, as well as to modify existing entries or provisions in Annexes I and II to this Regulation in order to adapt them to scientific and technical progress. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (20). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts should systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (29) When Annexes to this Regulation are amended to implement any listing of an additional, intentionally produced POP in the Protocol or in the Convention, the listing should be included in Annex II, instead of Annex I, only in exceptional cases and when duly justified. (30) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt measures concerning waste management and the minimum information to be provided by Member States in monitoring the implementation of this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (21). (31) In order to ensure transparency, impartiality and consistency at the level of enforcement activities, Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive, since non-compliance can result in damage to human health and to the environment. To ensure consistent and effective enforcement of this Regulation, the Member States should coordinate relevant activities and exchange information in the Forum for Exchange of Information on Enforcement established under Regulation (EC) No 1907/2006. Information on infringements of the provisions of this Regulation should be made public, where appropriate. (32) For the purposes of this Regulation other than matters relating to waste, the Commission should be assisted by the committee established by Regulation (EC) No 1907/2006, with a view to ensuring a consistent approach concerning chemicals legislation of the Union. (33) For the purposes of this Regulation, on matters relating to waste, the Commission should be assisted by the committee established by Directive 2008/98/EC with a view to ensuring a consistent approach concerning waste legislation of the Union. (34) Since the objective of this Regulation, namely to protect the environment and human health from POPs, cannot be sufficiently achieved by the Member States, owing to the transboundary effects of those pollutants, but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION: Article 1 Objective and subject matter Taking into account, in particular, the precautionary principle, the objective of this Regulation is to protect human health and the environment from POPs by prohibiting, phasing out as soon as possible, or restricting the manufacturing, placing on the market and use of substances subject to the Stockholm Convention on Persistent Organic Pollutants, hereinafter ‘the Convention’, or the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants, hereinafter ‘the Protocol’, by minimising, with a view to eliminating where feasible as soon as possible, releases of such substances, and by establishing provisions regarding waste consisting of, containing or contaminated by any of those substances. Where appropriate, Member States may apply stricter requirements than those laid down in this Regulation, in accordance with the TFEU. Article 2 Definitions For the purposes of this Regulation: (1) ‘placing on the market’ means placing on the market as defined in point 12 of Article 3 of Regulation (EC) No 1907/2006; (2) ‘article’ means article as defined in point 3 of Article 3 of Regulation (EC) No 1907/2006; (3) ‘substance’ means substance as defined in point 1 of Article 3 of Regulation (EC) No 1907/2006; (4) ‘mixture’ means mixture as defined in point 2 of Article 3 of Regulation (EC) No 1907/2006; (5) ‘manufacturing’ means manufacturing as defined in point 8 of Article 3 of Regulation (EC) No 1907/2006; (6) ‘use’ means use as defined in point 24 of Article 3 of Regulation (EC) No 1907/2006; (7) ‘import’ means import as defined in point 10 of Article 3 of Regulation (EC) No 1907/2006; (8) ‘waste’ means waste as defined in point 1 of Article 3 of Directive 2008/98/EC; (9) ‘disposal’ means disposal as defined in point 19 of Article 3 of Directive 2008/98/EC; (10) ‘recovery’ means recovery as defined in point 15 of Article 3 of Directive 2008/98/EC; (11) ‘closed-system site-limited intermediate’ means a substance that is manufactured for, and consumed in or used for chemical processing in order to be transformed into another substance (‘synthesis’) and where the manufacture of the intermediate and the synthesis of one or more other substances from that intermediate take place on the same site, by one or more legal entities, under strictly controlled conditions in that it is rigorously contained by technical means during its whole life cycle; (12) ‘unintentional trace contaminant’ means a level of a substance that is incidentally present in a minimal amount, below which the substance cannot be meaningfully used, and above the detection limit of existing detection methods to enable control and enforcement; (13) ‘stockpile’ means substances, mixtures or articles accumulated by the holder that consist of or contain any substance listed in Annex I or II. Article 3 Control of manufacturing, placing on the market and use, and the listing of substances 1. The manufacturing, placing on the market and use of substances listed in Annex I, whether on their own, in mixtures or in articles, shall be prohibited, subject to Article 4. 2. The manufacturing, placing on the market and use of substances listed in Annex II, whether on their own, in mixtures or in articles, shall be restricted, subject to Article 4. 3. Member States and the Commission shall, within the assessment and authorisation schemes for existing and new substances under the relevant Union legislation, take into consideration the criteria set out in paragraph 1 of Annex D to the Convention and take appropriate measures to control existing substances and prevent the manufacturing, placing on the market and use of new substances, which exhibit characteristics of POPs. 4. When preparing a proposal to the Council, pursuant to Article 218(9) TFEU, for the listing of a substance in accordance with the provisions of the Convention, the Commission shall be supported by the European Chemicals Agency (‘the Agency’), established by Regulation (EC) No 1907/2006, as referred to in point (c) of Article 8(1). The competent authorities of Member States may forward proposals for listing to the Commission. In the further stages of the listing process, the Agency shall provide support to the Commission and the competent authorities of the Member States, as referred to in point (e) of Article 8(1). 5. The Commission and the Agency shall, in all stages of the process referred to in paragraphs 3 and 4, cooperate with and inform the competent authorities of the Member States. 6. Waste consisting of, containing or contaminated by any substance listed in Annex IV is regulated by Article 7. Article 4 Exemptions from control measures 1. Article 3 shall not apply in the case of: (a) a substance used for laboratory-scale research or as a reference standard; (b) a substance present as an unintentional trace contaminant, as specified in the relevant entries of Annex I or II, in substances, mixtures or articles. 2. For a substance added to Annex I or II after 15 July 2019, Article 3 shall not apply for a six-month period if that substance is present in articles produced before or on the date that this Regulation becomes applicable to that substance. Article 3 shall not apply in the case of a substance present in articles already in use before or on the date that this Regulation or Regulation (EC) No 850/2004 became applicable to that substance, whichever date came first. Immediately upon becoming aware of articles as referred to in the first and second subparagraph, a Member State shall inform the Commission and the Agency accordingly. Whenever the Commission is so informed or otherwise learns of such articles, it shall, where appropriate, notify the Secretariat of the Convention accordingly without further delay. 3. Where a substance is listed in Part A of Annex I or in Part A of Annex II, a Member State wishing to permit, until the deadline specified in the relevant Annex, the manufacturing and use of that substance as a closed-system site-limited intermediate shall notify accordingly the Secretariat of the Convention. Such notification may be made only if the following conditions are satisfied: (a) following the request of a Member State or on the Commission's own initiative, an annotation has been entered in the relevant Annex, by means of a delegated act adopted on the basis of the fourth subparagraph; (b) the manufacturer demonstrates to the competent authority of the Member State in which the manufacturer is established that the manufacturing process will transform the substance into one or more other substances that do not exhibit the characteristics of a POP, ensuring that it is rigorously contained by technical means during its whole life cycle; (c) the manufacturer demonstrates to the competent authority of the Member State in which the manufacturer is established that the substance is a closed-system site-limited intermediate and that it is not expected that either humans or the environment will be exposed to any significant quantities of the substance during its production and use; (d) the manufacturer informs the Member State on the details of actual or estimated total manufacturing and use of the substance concerned and the nature of the closed-system site-limited process, specifying the amount of any non-transformed and unintentional trace contamination by any POP starting material in the final substance, mixture or article. Within one month of submission of the notification to the Secretariat of the Convention, the Member State shall communicate the notification to the other Member States, to the Commission and the Agency, and shall give details of actual or estimated total manufacturing and use of the substance concerned and the nature of the closed-system site-limited process, specifying the amount of any non-transformed and unintentional trace contamination by any POP starting material in the final substance, mixture or article. The Commission is empowered to adopt delegated acts in accordance with Article 18 in order to amend Annexes I and II by entering annotations expressly to the effect that manufacturing and use, as a closed-system site-limited intermediate, of a substance listed in Part A of the relevant Annex may be permitted, and to amend the deadlines in such annotations in cases where, following a repeat notification from the Member State concerned to the Secretariat of the Convention, express or tacit consent is issued under the Convention for the continued manufacturing and use of the substance for another period. 4. Waste consisting of, containing or contaminated by any substance listed in Annex IV is regulated by Article 7. Article 5 Stockpiles 1. The holder of a stockpile, which consists of or contains any substance listed in Annex I or II, for which no use is permitted, shall manage that stockpile as waste and in accordance with Article 7. 2. The holder of a stockpile greater than 50 kg, consisting of or containing any substance listed in Annex I or II, and the use of which is permitted shall provide the competent authority of the Member State in which the stockpile is established with information concerning the nature and size of that stockpile. Such information shall be provided within 12 months of the date that this Regulation or Regulation (EC) No 850/2004 became applicable to that substance, whichever date came first for the holder, and of relevant amendments to Annex I or II and annually thereafter until the deadline specified in Annex I or II for restricted use. The holder shall manage the stockpile in a safe, efficient and environmentally sound manner, in accordance with the thresholds and requirements laid down in Directive 2012/18/EU of the European Parliament and of the Council (22) and taking all adequate steps to ensure that the stockpile is managed in a manner that will protect human health and the environment. 3. Member States shall monitor the use and management of notified stockpiles. Article 6 Release reduction, minimisation and elimination 1. Within two years of the date of entry into force of this Regulation or Regulation (EC) No 850/2004, whichever date came first, Member States shall draw up inventories for the substances listed in Annex III released into air, water and land in accordance with their obligations under the Convention and the Protocol and shall subsequently maintain such inventories. 2. Member States shall communicate their action plans on measures to identify, characterise and minimise, with a view to eliminating where feasible as soon as possible, the total releases of substances listed in Annex III as recorded in their inventories drawn up in accordance with their obligations under the Convention, to the Commission, the Agency and to the other Member States as part of their national implementation plans, pursuant to Article 9. Such action plans shall include measures to promote the development of, and, where it is considered appropriate, shall require the use of substitute or modified substances, mixtures, articles and processes to prevent the formation and release of substances listed in Annex III. 3. Member States shall, when considering proposals to construct new facilities or to significantly modify existing facilities using processes that release chemicals listed in Annex III, give priority consideration to alternative processes, techniques or practices that have similar usefulness but which avoid the formation and release of substances listed in Annex III, without prejudice to Directive 2010/75/EU of the European Parliament and of the Council (23). Article 7 Waste management 1. Producers and holders of waste shall undertake all reasonable efforts to avoid, where feasible, contamination of this waste with substances listed in Annex IV. 2. Notwithstanding Council Directive 96/59/EC (24), waste consisting of, containing or contaminated by any substance listed in Annex IV to this Regulation shall be disposed of or recovered, without undue delay and in accordance with Part 1 of Annex V to this Regulation, in such a way as to ensure that the POP content is destroyed or irreversibly transformed so that the remaining waste and releases do not exhibit the characteristics of POPs. In carrying out such a disposal or recovery, any substance listed in Annex IV may be isolated from the waste, provided that this substance is subsequently disposed of in accordance with the first subparagraph. 3. Disposal or recovery operations that may lead to recovery, recycling, reclamation or re-use on their own of the substances listed in Annex IV shall be prohibited. 4. By way of derogation from paragraph 2: (a) waste containing or contaminated by any substance listed in Annex IV may be otherwise disposed of or recovered in accordance with the relevant Union legislation, provided that the content of the listed substances in the waste is below the concentration limits specified in Annex IV; (b) a Member State or the competent authority designated by that Member State may, in exceptional cases, allow wastes listed in Part 2 of Annex V containing or contaminated by a substance listed in Annex IV up to concentration limits specified in Part 2 of Annex V to be otherwise dealt with in accordance with a method listed in Part 2 of Annex V, provided that the following conditions are fulfilled: (i) the holder concerned has demonstrated to the satisfaction of the competent authority of the Member State concerned that decontamination of the waste in relation to substances listed in Annex IV was not feasible, and that destruction or irreversible transformation of the POP content, performed in accordance with best environmental practice or best available techniques, does not represent the environmentally preferable option and the competent authority has subsequently authorised the alternative operation; (ii) the holder concerned has provided information on the POP content of the waste to the competent authority; (iii) the operation is in accordance with relevant Union legislation and with the conditions laid down in relevant additional measures referred to in paragraph 5; (iv) the Member State concerned has informed the other Member States, the Agency and the Commission of its authorisation and the justification for it. 5. The Commission may, where appropriate, and taking into consideration technical developments and relevant international guidelines and decisions and any authorisations granted by a Member State, or by the competent authority designated by that Member State in accordance with paragraph 4 and Annex V, adopt implementing acts concerning the implementation of this Article. In particular, the Commission may specify the format of the information to be submitted by Member States in accordance with point (b)(iv) of paragraph 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(3). 6. Member States shall take the necessary measures to ensure the control and traceability, in accordance with Article 17 of Directive 2008/98/EC, of waste containing or contaminated by a substance listed in Annex IV to this Regulation. Article 8 Tasks of the Agency and the Forum 1. The Agency shall, in addition to the tasks allocated to it under Articles 9, 10, 11, 13 and 17, carry out the following tasks: (a) with the agreement of the Commission, provide the designated competent authorities of the Member States and the members of the Forum for Exchange of Information on Enforcement established by Regulation (EC) No 1907/2006 (‘Forum’), as well as stakeholders as appropriate, with assistance and technical and scientific guidance in order to ensure the effective application of this Regulation; (b) upon request, provide the Commission with technical and scientific input and assist it in order to ensure the effective implementation of this Regulation; (c) provide technical and scientific support and input to the Commission as regards substances that may meet the criteria for listing in the Convention or the Protocol, taking into account, as appropriate, results from existing assessment schemes referred to in Article 3(3); (d) publish on its website a notice that a proposal for the listing of a substance will be prepared by the Commission, invite all interested parties to submit comments within eight weeks, and publish those comments on its website; (e) provide the Commission and the Member States with technical and scientific support in the preparation and review of the risk profile and the risk management evaluation of a substance considered under the Convention, invite all interested parties to submit comments or additional information, or both, within eight weeks and publish those comments on its website; (f) upon request, provide the Commission with technical and scientific support in implementing and further developing the Convention, in particular with respect to the POPs Review Committee; (g) compile, register, process and make available to the Commission and the competent authorities of the Member States all the information received or available pursuant to Article 4(2) and (3), point (b)(iv) of Article 7(4), Article 9(2) and Article 13(1). Where such information is non-confidential, the Agency shall make that information publicly available on its website and shall facilitate the exchange of that information with relevant information platforms such as those referred to in Article 13(2); (h) establish and maintain sections on its website for all matters relating to the implementation of this Regulation. 2. The Forum shall be used to coordinate a network of the Member States' authorities responsible for enforcement of this Regulation. The members of the Forum who are appointed by a Member State shall ensure that there is appropriate coordination between the tasks of the Forum and the work of their Member State competent authority. The Forum shall involve the enforcement authorities of Member States responsible for waste when dealing with waste-related issues. 3. The Secretariat of the Agency shall carry out the tasks allocated to the Agency under this Regulation. Article 9 Implementation plans 1. When preparing and updating their national implementation plans, Member States shall, in accordance with their national procedures, give the public early and effective opportunities to participate in this process. 2. As soon as a Member State has adopted its national implementation plan in accordance with its obligations under the Convention, it shall make it publicly available and communicate its publication to the Commission, the Agency and to the other Member States. 3. When Member States are preparing and updating their implementation plans, the Commission, supported by the Agency, and the Member States shall exchange information on the content, including information on measures taken at national level to identify and assess sites contaminated by POPs, as appropriate. 4. The Commission, supported by the Agency, shall maintain a plan for the implementation of Union obligations under the Convention and shall publish, review and update that plan, as appropriate. Article 10 Monitoring 1. The Commission, supported by the Agency, and the Member States shall establish or maintain, as appropriate, in close cooperation, appropriate programmes and mechanisms, consistent with the state of the art, for the regular provision of comparable monitoring data on the presence of substances as listed in Part A of Annex III in the environment. When establishing or maintaining such programmes and mechanisms, due account shall be taken of developments under the Protocol and the Convention. 2. The Commission shall regularly assess the possible need for the mandatory monitoring of a substance listed in Part B of Annex III. In the light of such an assessment and any data made available to it by Member States, the Commission is empowered to adopt delegated acts in accordance with Article 18 to amend Annex III in order to move, where appropriate, a substance from Part B of Annex III to Part A thereof. Article 11 Information exchange 1. The Commission, the Agency and the Member States shall facilitate and undertake the exchange within the Union and with third countries of information relevant to the reduction, minimisation or elimination, where feasible, of the manufacturing, use and release of POPs and to alternatives to those substances, specifying the risks and the economic and social costs related to such alternatives. 2. The Commission, the Agency and the Member States, as appropriate, shall promote and facilitate with regard to POPs: (a) awareness programmes, including relating to their health and environmental effects and their alternatives and on the reduction or elimination of their manufacture, use and release, especially for: (i) policy- and decision-makers; (ii) particularly vulnerable groups; (b) the provision of public information; (c) training, including workers, scientists, educators and technical and managerial personnel. 3. Without prejudice to Regulations (EC) No 1049/2001, and (EC) No 1367/2006 and Directive 2003/4/EC, information on the health and safety of humans and the environment shall not be regarded as confidential. The Commission, the Agency and the Member States that exchange information with a third country shall protect any confidential information in accordance with Union law. Article 12 Technical assistance In accordance with Articles 12 and 13 of the Convention, the Commission and the Member States shall cooperate in providing appropriate and timely technical and financial assistance to developing countries and countries with economies in transition to assist them, upon request and within available resources and taking into account their particular needs, to develop and strengthen their capacity to fully implement their obligations under the Convention. Such support may also be channelled through regional centres, as identified under the Convention, non-governmental organisations or the Agency. Article 13 Monitoring of implementation 1. Without prejudice to Directives 2003/4/EC and 2007/2/EC, Member States shall draw up and publish a report containing: (a) information on the application of this Regulation, including information on enforcement activities, infringements and penalties; (b) information compiled from the notifications received pursuant to Article 4(2) and (3), Article 5(2) and point (b)(iv) of Article 7(4); (c) information compiled from the release inventories drawn up pursuant to Article 6(1); (d) information on implementation in accordance with the national implementation plans drawn up pursuant to Article 9(2); (e) information on the presence of substances listed in Part A of Annex III in the environment, as compiled pursuant to Article 10; (f) annual monitoring and statistical data on the actual or estimated total manufacturing and placing on the market of any substance listed in Annex I or II, including relevant indicators, overview maps, reports. Member States shall update the report annually as far as new data or information is available and otherwise at least every three years. Members States shall give the Commission and the Agency access to the information contained in the reports. 2. Where a Member State shares the information referred to in point (e) of paragraph 1 with the Information Platform for Chemical Monitoring, this shall be indicated by that Member State in its report and the Member State shall be considered to have fulfilled its reporting obligations under that point. Where the information referred to in point (e) of paragraph 1 is contained in the report of a Member State provided to the Agency, the Agency shall use the Information Platform for Chemical Monitoring for compiling, storing and sharing that information. 3. Regarding the substances listed in the Convention, the Commission, supported by the Agency, shall, at the intervals determined by the Conference of the Parties of the Convention, compile a report on the basis of the information provided by the Member States to the Agency in accordance with point (f) of paragraph 1 and communicate it to the Secretariat of the Convention. 4. The Agency shall compile and publish a Union overview report on the basis of the data referred to in paragraphs 1 and 2 that is published or notified by the Member States. The Union overview report shall include, as appropriate, indicators for outputs, results and impact of this Regulation, Union overview maps and Member State reports. The Union overview report shall be updated by the Agency at least once every six months or following receipt of a request from the Commission. 5. The Commission may adopt implementing acts concerning the minimum information to be provided in accordance with paragraph 1, including the definition of relevant indicators, overview maps and reports referred to in point (f) of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(3). Article 14 Penalties Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Where Member States have not already done so before the entry into force of this Regulation, they shall notify those rules and measures to the Commission on 16 July 2020 at the latest and shall notify it, without delay, of any subsequent amendment affecting them. Article 15 Amendment of Annexes 1. The Commission is empowered to adopt delegated acts in accordance with Article 18 to amend the Annexes I, II and III to this Regulation in order to adapt them to changes to the list of substances set out in the Annexes to the Convention or the Protocol, on the basis that the Union has supported the change concerned by means of a Council decision adopted in accordance with Article 218(9) TFEU, or to modify existing entries or provisions in Annexes I and II to this Regulation in order to adapt them to scientific and technical progress. Whenever the Commission amends Annex I, II or III to this Regulation, it shall adopt a separate delegated act in respect of each substance. 2. The Commission shall keep Annexes IV and V under constant review and shall, where appropriate, make legislative proposals to amend these Annexes in order to adapt them to the changes to the list of substances set out in the Annexes to the Convention or the Protocol or to modify existing entries or provisions in the Annexes to this Regulation in order to adapt them to scientific and technical progress. Article 16 The budget of the Agency 1. For the purposes of this Regulation, the revenues of the Agency shall consist of: (a) a subsidy from the Union, entered in the general budget of the Union (Commission Section); (b) any voluntary contribution from the Member States. 2. Revenues and expenditure for activities under this Regulation shall be combined with those relating to activities under Regulation (EU) No 649/2012 and shall be reflected in the same section in the Agency's budget. The revenues of the Agency referred to in paragraph 1 shall be used for carrying out its tasks under this Regulation. Article 17 Formats and software for publication or notification of information The Agency shall, in cooperation with the Member States, specify formats and software for the publication or notification of data by Member States pursuant to this Regulation and shall make them available free of charge on its website. In relation to spatial data sets and spatial data services, Member States and the Agency shall design the formats in accordance with the requirements of Directive 2007/2/EC. Member States and other parties subject to this Regulation shall use those formats and software in their data management or data exchange with the Agency. Article 18 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 4(3), 10(2) and 15(1) shall be conferred on the Commission for a period of five years from 15 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 4(3), 10(2) and 15(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 4(3), 10(2) and 15(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 19 Competent authorities Each Member State shall designate a competent authority or authorities responsible for the administrative tasks and enforcement required by this Regulation. It shall inform the Commission of such designation at the latest three months after the entry into force of this Regulation, unless it has already done so before the entry into force of this Regulation, and shall also inform the Commission of any change of designated competent authority. Article 20 Committee procedure 1. Except in the case referred to in paragraph 2, the Commission shall be assisted by the Committee established by Article 133 of Regulation (EC) No 1907/2006. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. For matters relating to waste, the Commission shall be assisted by the Committee established by Article 39 of Directive 2008/98/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 21 Repeal Regulation (EC) No 850/2004 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VII. Article 22 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 367, 10.10.2018, p. 93. (2) Position of the European Parliament of 18 April 2019 (not yet published in the Official Journal) and decision of the Council of 13 June 2019. (3) Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7). (4) OJ L 81, 19.3.2004, p. 37. (5) OJ L 209, 31.7.2006, p. 3. (6) OJ L 63, 6.3.2003, p. 29. (7) OJ L 39, 16.2.1993, p. 3. (8) OJ L 142, 2.6.2017, p. 4. (9) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). (10) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). (11) Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1). (12) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3). (13) Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p. 60). (14) Commission Decision 2014/955/EU of 18 December 2014 amending Decision 2000/532/EC on the list of waste pursuant to Directive 2008/98/EC of the European Parliament and of the Council (OJ L 370, 30.12.2014, p. 44). (15) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (16) Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, p. 13). (17) Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26). (18) OJ L 354, 28.12.2013, p. 171. (19) Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1). (20) OJ L 123, 12.5.2016, p. 1. (21) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (22) Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC (OJ L 197, 24.7.2012, p. 1). (23) Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17). (24) Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT) (OJ L 243, 24.9.1996, p. 31). ANNEX I Part A Substances listed in the Convention and in the Protocol as well as substances listed only in the Convention Substance CAS No EC No Specific exemption on intermediate use or other specification Tetrabromodiphenyl ether C12H6Br4O 40088-47-9 and others 254-787-2 and others 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of Tetrabromodiphenyl ether equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. 2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the sum of the concentration of those substances up to 500 mg/kg where they are present in mixtures or articles, subject to review and assessment by the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard to health and the environment. 3. By way of derogation, the manufacturing, placing on the market and use of the following shall be allowed: electrical and electronic equipment within the scope of Directive 2011/65/EC of the European Parliament and of the Council (1). 4. Use of articles already in use in the Union before 25 August 2010 containing Tetrabromodiphenyl ether shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. Pentabromodiphenyl ether C12H5Br5O 32534-81-9 and others 251-084-2 and others 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of pentabromodiphenyl ether equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. 2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the sum of the concentration of those substances up to 500 mg/kg where they are present in mixtures or articles, subject to review and assessment by the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard to health and the environment. 3. By way of derogation, the manufacturing, placing on the market and use of the following shall be allowed: electrical and electronic equipment within the scope of Directive 2011/65/EC. 4. Use of articles already in use in the Union before 25 August 2010 containing Pentabromodiphenyl ether shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. Hexabromodiphenyl ether C12H4Br6O 36483-60-0 and others 253-058-6 and others 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of hexabromodiphenyl ether equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. 2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the sum of the concentration of those substances up to 500 mg/kg where they are present in mixtures or articles, subject to review and assessment by the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard to health and the environment. 3. By way of derogation, the manufacturing, placing on the market and use of the following shall be allowed: electrical and electronic equipment within the scope of Directive 2011/65/EC. 4. Use of articles already in use in the Union before 25 August 2010 containing Hexabromodiphenyl ether shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. Heptabromodiphenyl ether C12H3Br7O 68928-80-3 and others 273-031-2 and others 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of heptabromodiphenyl ether equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. 2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the sum of the concentration of those substances up to 500 mg/kg where they are present in mixtures or articles, subject to review and assessment by the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard to health and the environment. 3. By way of derogation, the manufacturing, placing on the market and use of the following shall be allowed: electrical and electronic equipment within the scope of Directive 2011/65/EC. 4. Use of articles already in use in the Union before 25 August 2010 containing Heptabromodiphenyl ether shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. Bis(pentabromophenyl) ether (decabromodiphenyl ether; decaBDE) 1163-19-5 214-604-9 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of decaBDE equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances. 2. For the purposes of the entries on tetra-, penta-, hexa-, hepta- and decaBDE, point (b) of Article 4(1) shall apply to the sum of the concentrations of those substances up to 500 mg/kg where they are present in mixtures or articles, subject to review and assessment by the Commission by 16 July 2021. This review shall assess, inter alia, all relevant impacts with regard to health and the environment. 3. By way of derogation, the manufacturing, placing on the market and use of decaBDE shall be allowed for the following purposes, provided that Member States report to the Commission by December 2019 in accordance with the Convention: (a) in the manufacturing of an aircraft, for which type approval has been applied for before 2 March 2019 and has been received before December 2022, until 18 December 2023, or, in cases where the continuing need is justified, until 2 March 2027; (b) in the manufacturing of spare parts for either of the following: (i) an aircraft, for which type approval has been applied for before 2 March 2019 and has been received before December 2022, produced before 18 December 2023, or, in cases where the continuing need is justified, produced before 2 March 2027, until the end of service life of that aircraft; (ii) motor vehicles within the scope of Directive 2007/46/EC of the European Parliament and of the Council (2), produced before 15 July 2019, either until 2036 or the end of service life of those motor vehicles, whichever date comes earlier; (c) electric and electronic equipment within the scope of Directive 2011/65/EC. 4. The specific exemptions for spare parts for use in motor vehicles referred to in point 2(b)(ii) shall apply for the manufacturing and use of commercial decaBDE falling into one or more of the following categories: (a) powertrain and under-hood applications such as battery mass wires, battery interconnection wires, mobile air condition (MAC) pipes, powertrains, exhaust manifold bushings, under-hood insulation, wiring and harness under-hood (engine wiling, etc.), speed sensors, hoses, fan modules and knock sensors; (b) fuel system applications such as fuel hoses, fuel tanks and fuel tanks under body; (c) pyrotechnical devices and applications affected by pyrotechnical devices such as airbag ignition cables, seat covers/fabrics, only if airbag relevant and airbags (front and side). 5. Use of articles already in use before 15 July 2019 in the Union containing decaBDE shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. 6. Without prejudice to the application of other Union provisions on the classification, packaging and labelling of substances and mixtures, articles in which decaBDE is used shall be identifiable by labelling or other means throughout its life cycle. 7. The placing on the market and use of articles containing decaBDE imported for the purposes of the specific exemptions in point 2 shall be allowed until the expiry of those exemptions. Point 6 shall apply as if such articles were produced pursuant to the exemption in point 2. Such articles already in use by the date of expiry of the relevant exemption may continue to be used. 8. For the purposes of this entry ‘aircraft’ means the following: (a) a civil aircraft produced in accordance with a type certificate issued under Regulation (EC) No 216/2008 of the European Parliament and of the Council (3) or with a design approval issued under the national regulations of a contracting state of ICAO, or for which a certificate of airworthiness has been issued by an ICAO Contracting State under Annex 8 to the Convention on International Civil Aviation; (b) a military aircraft. Perfluorooctane sulfonic acid and its derivatives (PFOS) C8F17SO2X (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers) 1763-23-1 2795-39-3 29457-72-5 29081-56-9 70225-14-8 56773-42-3 251099-16-8 4151-50-2 31506-32-8 1691-99-2 24448-09-7 307-35-7 and others 217-179-8 220-527-1 249-644-6 249-415-0 274-460-8 260-375-3 223-980-3 250-665-8 216-887-4 246-262-1 206-200-6 and others 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOS equal to or below 10 mg/kg (0,001 % by weight) where it is present in substances or in mixtures. 2. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of PFOS in semi-finished products or articles, or parts thereof, if the concentration of PFOS is lower than 0,1 % by weight calculated with reference to the mass of structurally or micro-structurally distinct parts that contain PFOS or, for textiles or other coated materials, if the amount of PFOS is lower than 1 μg/m2 of the coated material. 3. Use of articles already in use in the Union before 25 August 2010 containing PFOS shall be allowed. Article 4(2), third and fourth subparagraphs shall apply in relation to such articles. 4. If the quantity released into the environment is minimised, manufacturing and placing on the market is allowed for the following specific uses provided that Member States report to the Commission every four years on progress made to eliminate PFOS: mist suppressants for non-decorative hard chromium (VI) plating in closed loop systems. Where such a derogation concerns production or use in an installation within the scope of Directive 2008/1/EC of the European Parliament and of the Council (4), the relevant best available techniques for the prevention and minimisation of emissions of PFOS described in the information published by the Commission pursuant to Article 17(2), second subparagraph, of Directive 2008/1/EC shall apply. As soon as new information on details of uses and safer alternative substances or technologies becomes available, the Commission shall review the derogation in the second subparagraph so that: (a) the uses of PFOS will be phased out as soon as the use of safer alternatives is technically and economically feasible; (b) a derogation can only be continued for essential uses for which safer alternatives do not exist and where the efforts undertaken to find safer alternatives have been reported on; (c) releases of PFOS into the environment have been minimised by applying best available techniques. 5. Once standards are adopted by the European Committee for Standardisation (CEN) they shall be used as the analytical test methods for demonstrating the conformity of substances, mixtures and articles to points 1 and 2. Any other analytical method for which the user can prove equivalent performance could be used as an alternative to the CEN standards. DDT (1,1,1-trichloro-2,2-bis(4-chlorophenyl)ethane) 50-29-3 200-024-3 — Chlordane 57-74-9 200-349-0 — Hexachlorocyclohexanes, including lindane 58-89-9 200-401-2 — 319-84-6 206-270-8 319-85-7 206-271-3 608-73-1 210-168-9 Dieldrin 60-57-1 200-484-5 — Endrin 72-20-8 200-775-7 — Heptachlor 76-44-8 200-962-3 — Endosulfan 115-29-7 959-98-8 33213-65-9 204-079-4 1. Placing on the market and use of articles already in use before or on 10 July 2012 containing endosulfan shall be allowed. 2. Article 4(2), third and fourth subparagraphs shall apply to articles referred to in point 1. Hexachlorobenzene 118-74-1 204-273-9 — Chlordecone 143-50-0 205-601-3 — Aldrin 309-00-2 206-215-8 — Pentachlorobenzene 608-93-5 210-172-0 — Polychlorinated Biphenyls (PCB) 1336-36-3 and others 215-648-1 and others Without prejudice to Directive 96/59/EC, articles already in use at the time of the entry into force of this Regulation are allowed to be used. Member States shall identify and remove from use equipment (e.g. transformers, capacitors or other receptacles containing liquid stocks) containing more than 0,005 % PCBs and volumes greater than 0,05 dm3, as soon as possible but no later than 31 December 2025. Mirex 2385-85-5 219-196-6 — Toxaphene 8001-35-2 232-283-3 — Hexabromobiphenyl 36355-01-8 252-994-2 — 1 Hexabromocyclododecane ‘Hexabromocyclododecane’ means: hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha-hexabromocyclododecane; beta-hexabromocyclododecane; and gamma-hexabromocyclododecane 25637-99-4, 3194-55-6, 134237-50-6, 134237-51-7, 134237-52-8 247-148-4, 221-695-9 1. For the purposes of this entry, point (b) of Article 4(1) shall apply to concentrations of hexabromocyclododecane equal to or below 100 mg/kg (0,01 % by weight) where it is present in substances, mixtures, articles or as constituents of the flame-retarded articles, subject to review by the Commission by 22 March 2019. 2. Expanded polystyrene articles containing hexabromocyclododecane already in use in buildings before 21 February 2018 in accordance with Commission Regulation (EU) 2016/293 (5) and Commission Implementing Decision No 2016/C 12/06 (6), and extruded polystyrene articles containing hexabromocyclododecane already in use in buildings before 23 June 2016 may continue to be used. Article 4(2), third and fourth subparagraphs shall apply to such articles. 3. Without prejudice to the application of other Union provisions on the classification, packaging and labelling of substances and mixtures, expanded polystyrene placed on the market after 23 March 2016 in which hexabromocyclododecane was used shall be identifiable by labelling or other means throughout its life cycle. Hexachlorobutadiene 87-68-3 201-765-5 1. Placing on the market and use of articles already in use before or on 10 July 2012 containing hexachlorobutadiene shall be allowed. 2. Article 4(2), third and fourth subparagraphs shall apply to articles referred to in point 1. Pentachlorophenol and its salts and esters 87-86-5 and others 201-778-6 and others Polychlorinated naphthalenes (7) 70776-03-3 and others 274-864-4 and others 1. Placing on the market and use of articles already in use before or on 10 July 2012 containing polychlorinated naphthalenes shall be allowed. 2. Article 4(2), third and fourth subparagraphs shall apply to articles referred to in point 1. Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs) 85535-84-8 and others 287-476-5 1. By way of derogation, the manufacturing, placing on the market and use of substances or mixtures containing SCCPs in concentrations lower than 1 % by weight or articles containing SCCPs in concentrations lower than 0,15 % by weight shall be allowed. 2. Use shall be allowed in respect of: (a) conveyor belts in the mining industry and dam sealants containing SCCPs already in use before or on 4 December 2015; and (b) articles containing SCCPs other than those referred to in point (a) already in use before or on 10 July 2012. 3. The third and fourth subparagraphs of Article 4(2) shall apply to the articles referred to in point 2. Part B Substances listed only in the Protocol Substance CAS No EC No Specific exemption on intermediate use or other specification (1) Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88). (2) Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (OJ L 263, 9.10.2007, p.1). (3) Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 79, 19.3.2008, p. 1). (4) Directive 2008/1/EC of the European Parliament and of the Council of 15 January 2008 concerning integrated pollution prevention and control (OJ L 24, 29.1.2008, p. 8). (5) Commission Regulation (EU) 2016/293 of 1 March 2016 amending Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants as regards Annex I (OJ L 55, 2.3.2016, p. 4). (6) OJ C 10, 13.1.2016, p. 3. (7) Polychlorinated naphthalenes means chemical compounds based on the naphthalene ring system, where one or more hydrogen atoms have been replaced by chlorine atoms. ANNEX II LIST OF SUBSTANCES SUBJECT TO RESTRICTIONS Part A Substances listed in the Convention and in the Protocol Substance CAS No EC No Conditions of restriction Part B Substances listed only in the Protocol Substance CAS No EC No Conditions of restriction ANNEX III LIST OF SUBSTANCES SUBJECT TO RELEASE REDUCTION PROVISIONS PART A Substance (CAS No) Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) Polychlorinated biphenyls (PCB) PART B Hexachlorobenzene (HCB) (CAS No 118-74-1) Polycyclic aromatic hydrocarbons (PAHs) (1) Pentachlorobenzene (CAS No 608-93-5) Hexachlorobutadiene (CAS No 87-68-3) Polychlorinated naphthalenes (CAS No 70776-03-3 and others) (1) For the purpose of emission inventories, the following four compound indicators shall be used: benzo(a)pyrene, benzo(b) fluoranthene, benzo(k)fluoranthene and indeno(1,2,3-cd)pyrene. ANNEX IV List of substances subject to waste management provisions set out in Article 7 Substance CAS No EC No Concentration limit referred to in Article 7(4)(a) Endosulfan 115-29-7 959-98-8 33213-65-9 204-079-4 50 mg/kg Hexachlorobutadiene 87-68-3 201-765-5 100 mg/kg Polychlorinated naphthalenes (1) 10 mg/kg Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs) 85535-84-8 287-476-5 10 000 mg/kg Tetrabromodiphenyl ether C12H6Br4O 40088-47-9 and others 254-787-2 and others Sum of the concentrations of tetrabromodiphenyl ether, pentabromodiphenyl ether, hexabromodiphenyl ether, heptabromodiphenyl ether and decabromodiphenyl ether: 1 000 mg/kg. The Commission shall review that concentration limit and shall, where appropriate and in accordance with the Treaties, adopt a legislative proposal to lower that value to 500 mg/kg. The Commission shall carry out such review as soon as possible and, in any event, not later than 16 July 2021. Pentabromodiphenyl ether C12H5Br5O 32534-81-9 and others 251-084-2 and others Hexabromodiphenyl ether C12H4Br6O 36483-60-0 and others 253-058-6 and others Heptabromodiphenyl ether C12H3Br7O 68928-80-3 and others 273-031-2 and others Decabromodiphenyl ether C12Br10O 1163-19-5 and others 214-604-9 and others Perfluorooctane sulfonic acid and its derivatives (PFOS) C8F17SO2X (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers) 1763-23-1 2795-39-3 29457-72-5 29081-56-9 70225-14-8 56773-42-3 251099-16-8 4151-50-2 31506-32-8 1691-99-2 24448-09-7 307-35-7 and others 217-179-8 220-527-1 249-644-6 249-415-0 274-460-8 260-375-3 223-980-3 250-665-8 216-887-4 246-262-1 206-200-6 and others 50 mg/kg Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) 15 μg/kg (2) DDT (1,1,1-trichloro-2,2-bis (4-chlorophenyl)ethane) 50-29-3 200-024-3 50 mg/kg Chlordane 57-74-9 200-349-0 50 mg/kg Hexachlorocyclohexanes, including lindane 58-89-9 319-84-6 319-85-7 608-73-1 210-168-9 200-401-2 206-270-8 206-271-3 50 mg/kg Dieldrin 60-57-1 200-484-5 50 mg/kg Endrin 72-20-8 200-775-7 50 mg/kg Heptachlor 76-44-8 200-962-3 50 mg/kg Hexachlorobenzene 118-74-1 204-273-9 50 mg/kg Chlordecone 143-50-0 205-601-3 50 mg/kg Aldrin 309-00-2 206-215-8 50 mg/kg Pentachlorobenzene 608-93-5 210-172-0 50 mg/kg Polychlorinated Biphenyls (PCB) 1336-36-3 and others 215-648-1 50 mg/kg (3) Mirex 2385-85-5 219-196-6 50 mg/kg Toxaphene 8001-35-2 232-283-3 50 mg/kg Hexabromobiphenyl 36355-01-8 252-994-2 50 mg/kg Hexabromocyclododecane (4) 25637-99-4, 3194-55-6, 134237-50-6, 134237-51-7, 134237-52-8 247-148-4 221-695-9 1 000 mg/kg, subject to review by the Commission by 20 April 2019 (1) Polychlorinated naphthalenes means chemical compounds based on the naphthalene ring system, where one or more hydrogen atoms have been replaced by chlorine atoms. (2) The limit is calculated as PCDD and PCDF according to the following toxic equivalency factors (TEFs): PCDD TEF PCDF TEF PCDD TEF 2,3,7,8-TeCDD 1 2,3,7,8-TeCDF 0,1 1,2,3,6,7,8-HxCDF 0,1 1,2,3,7,8-PeCDD 1 1,2,3,7,8-PeCDF 0,03 1,2,3,7,8,9-HxCDF 0,1 1,2,3,4,7,8-HxCDD 0,1 2,3,4,7,8-PeCDF 0,3 2,3,4,6,7,8-HxCDF 0,1 1,2,3,6,7,8-HxCDD 0,1 1,2,3,4,7,8-HxCDF 0,1 1,2,3,4,6,7,8-HpCDF 0,01 1,2,3,7,8,9-HxCDD 0,1 1,2,3,4,7,8,9-HpCDF 0,01 1,2,3,4,6,7,8-HpCDD 0,01 OCDF 0,0003 OCDD 0,0003 (3) The calculation method laid down in European standards EN 12766-1 and EN 12766-2 shall apply. (4) ‘Hexabromocyclododecane’ means hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha-hexabromocyclododecane, beta-hexabromocyclododecane and gamma-hexabromocyclododecane. ANNEX V WASTE MANAGEMENT Part 1 Disposal and recovery under Article 7(2) The following disposal and recovery operations, as provided for in Annexes I and II of Directive 2008/98/EC, are permitted for the purposes of Article 7(2), when applied in such a way as to ensure that the persistent organic pollutant content is destroyed or irreversibly transformed D9 Physico-chemical treatment. D10 Incineration on land. R1 Use principally as a fuel or other means to generate energy, excluding waste containing PCBs. R4 Recycling/reclamation of metals and metal compounds, under the following conditions: The operations are restricted to residues from iron- and steel-making processes such as dusts or sludges from gas treatment or mill scale or zinc-containing filter dusts from steelworks, dusts from gas cleaning systems of copper smelters and similar wastes and lead-containing leaching residues of the non-ferrous metal production. Waste containing PCBs is excluded. The operations are restricted to processes for the recovery of iron and iron alloys (blast furnace, shaft furnace and hearth furnace) and non-ferrous metals (Waelz rotary kiln process, bath melting processes using vertical or horizontal furnaces), provided the facilities meet as minimum requirements the emission limit values for PCDDs and PCDFs laid down in accordance with Directive 2010/75/EU of the European Parliament and of the Council (1), whether or not the processes are subject to that Directive and without prejudice to the other provisions of the Directive. Pre-treatment operation prior to destruction or irreversible transformation pursuant to this Part of this Annex may be performed, provided that a substance listed in Annex IV that is isolated from the waste during the pre-treatment is subsequently disposed of in accordance with this Part of this Annex. Where only part of a product or waste, such as waste equipment, contains or is contaminated with persistent organic pollutants, it shall be separated and then disposed of in accordance with the requirements of this Regulation. In addition, repackaging and temporary storage operations may be performed prior to such pre-treatment or prior to destruction or irreversible transformation pursuant to this part of this Annex. Part 2 Wastes and operations to which Article 7(4)(b) applies The following operations are permitted for the purposes of Article 7(4)(b) in respect of the wastes specified, defined by the six-digit code as classified in Commission Decision 2000/532/EC (2). Pre-treatment operations prior to permanent storage pursuant to this part of this Annex may be performed, provided that a substance listed in Annex IV that is isolated from the waste during the pre-treatment is subsequently disposed of in accordance with Part 1 of this Annex. In addition, repackaging and temporary storage operations may be performed prior to such pre-treatment or prior to permanent storage pursuant to this part of this Annex. Wastes as classified in Decision 2000/532/EC Maximum concentration limits of substances listed in Annex IV (3) Operation 10 WASTES FROM THERMAL PROCESSES Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs): 10 000 mg/kg; Aldrin: 5 000 mg/kg; Chlordane: 5 000 mg/kg; Chlordecone: 5 000 mg/kg; DDT (1,1,1-trichloro-2,2-bis (4-chlorophenyl) ethane): 5 000 mg/kg; Dieldrin: 5 000 mg/kg; Endosulfan: 5 000 mg/kg; Endrin: 5 000 mg/kg; Heptachlor: 5 000 mg/kg; Hexabromobiphenyl: 5 000 mg/kg; Hexabromocyclododecane (5): 1 000 mg/kg; Hexachlorobenzene: 5 000 mg/kg; Hexachlorobutadiene: 1 000 mg/kg; Hexachlorocyclohexanes, including lindane: 5 000 mg/kg; Mirex: 5 000 mg/kg; Pentachlorobenzene: 5 000 mg/kg; Perfluorooctane sulfonic acid and its derivatives (PFOS) (C8F17SO2X) (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers): 50 mg/kg; Polychlorinated Biphenyls (PCB) (8): 50 mg/kg; Polychlorinated dibenzo-p-dioxins and dibenzofurans: 5 mg/kg; Polychlorinated naphthalenes (*): 1 000 mg/kg; Sum of the concentrations of tetrabromodiphenyl ether C12H6Br4O), pentabromodiphenyl ether (C12H5Br5O), hexabromodiphenyl ether (C12H4Br6O)and heptabromodiphenyl ether (C12H3Br7O): 10 000 mg/kg; Toxaphene: 5 000 mg/kg. Permanent storage shall be allowed only when all the following conditions are met: (1) The storage takes place in one of the following locations: — safe, deep, underground, hard rock formations, — salt mines, — a landfill site for hazardous waste, provided that the waste is solidified or partly stabilised where technically feasible as required for classification of the waste in subchapter 19 03 of Decision 2000/532/EC. (2) The provisions of Council Directive 1999/31/EC (6) and Council Decision 2003/33/EC (7) were respected. (3) It has been demonstrated that the selected operation is environmentally preferable. 10 01 Wastes from power stations and other combustion plants (except 19) 10 01 14 * (4) Bottom ash, slag and boiler dust from co-incineration containing hazardous substances 10 01 16 * Fly ash from co-incineration containing hazardous substances 10 02 Wastes from the iron and steel industry 10 02 07 * Solid wastes from gas treatment containing hazardous substances 10 03 Wastes from aluminium thermal metallurgy 10 03 04 * Primary production slags 10 03 08 * Salt slags from secondary production 10 03 09 * Black drosses from secondary production 10 03 19 * Flue-gas dust containing hazardous substances 10 03 21 * Other particulates and dust (including ball-mill dust) containing hazardous substances 10 03 29 * Wastes from treatment of salt slags and black drosses containing hazardous substances 10 04 Wastes from lead thermal metallurgy 10 04 01 * Slags from primary and secondary production 10 04 02 * Dross and skimmings from primary and secondary production 10 04 04 * Flue-gas dust 10 04 05 * Other particulates and dust 10 04 06 * Solid wastes from gas treatment 10 05 Wastes from zinc thermal metallurgy 10 05 03 * Flue-gas dust 10 05 05 * Solid waste from gas treatment 10 06 Wastes from copper thermal metallurgy 10 06 03 * Flue-gas dust 10 06 06 * Solid wastes from gas treatment 10 08 Wastes from other non-ferrous thermal metallurgy 10 08 08 * Salt slag from primary and secondary production 10 08 15 * Flue-gas dust containing hazardous substances 10 09 Wastes from casting of ferrous pieces 10 09 09 * Flue-gas dust containing hazardous substances 16 WASTES NOT OTHERWISE SPECIFIED IN THE LIST 16 11 Waste linings and refractories 16 11 01 * Carbon-based linings and refractories from metallurgical processes containing hazardous substances 16 11 03 * Other linings and refractories from metallurgical processes containing hazardous substances 17 CONSTRUCTION AND DEMOLITION WASTES (INCLUDING EXCAVATED SOIL FROM CONTAMINATED SITES) 17 01 Concrete, bricks, tiles and ceramics 17 01 06 * Mixtures of, or separate fractions of concrete, bricks, tiles and ceramics containing hazardous substances 17 05 Soil (including excavated soil from contaminated sites), stones and dredging spoil 17 05 03 * Soil and stones containing hazardous substances 17 09 Other construction and demolition wastes 17 09 02 * Construction and demolition wastes containing PCB, excluding PCB containing equipment 17 09 03 * Other construction and demolition wastes (including mixed wastes) containing hazardous substances 19 WASTES FROM WASTE MANAGEMENT FACILITIES, OFF-SITE WASTE WATER TREATMENT PLANTS AND THE PREPARATION OF WATER INTENDED FOR HUMAN CONSUMPTION AND WATER FROM INDUSTRIAL USE 19 01 Wastes from incineration or pyrolysis of waste 19 01 07 * Solid wastes from gas treatment 19 01 11 * Bottom ash and slag containing hazardous substances 19 01 13 * Fly ash containing hazardous substances 19 01 15 * Boiler dust containing hazardous substances 19 04 Vitrified waste and waste from vitrification 19 04 02 * Fly ash and other flue-gas treatment wastes 19 04 03 * Non-vitrified solid phase The maximum concentration limit of polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD and PCDF) shall be calculated according to the following toxic equivalency factors (TEFs): PCDD TEF 2,3,7,8-TeCDD 1 1,2,3,7,8-PeCDD 1 1,2,3,4,7,8-HxCDD 0,1 1,2,3,6,7,8-HxCDD 0,1 1,2,3,7,8,9-HxCDD 0,1 1,2,3,4,6,7,8-HpCDD 0,01 OCDD 0,0003 PCDF TEF 2,3,7,8-TeCDF 0,1 1,2,3,7,8-PeCDF 0,03 2,3,4,7,8-PeCDF 0,3 1,2,3,4,7,8-HxCDF 0,1 1,2,3,6,7,8-HxCDF 0,1 1,2,3,7,8,9-HxCDF 0,1 2,3,4,6,7,8-HxCDF 0,1 1,2,3,4,6,7,8-HpCDF 0,01 1,2,3,4,7,8,9-HpCDF 0,01 OCDF 0,0003 (1) Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17). (2) Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (OJ L 226, 6.9.2000, p. 3). (3) These limits apply exclusively to a landfill site for hazardous waste and do not apply to permanent underground storage facilities for hazardous waste, including salt mines. (4) Any waste marked with an asterisk ‘*’ is considered as hazardous waste pursuant to Directive 2008/98/EC and is subject to the provisions of that Directive. (5) ‘Hexabromocyclododecane’ means hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha- hexabromocyclododecane, beta- hexabromocyclododecane and gamma- hexabromocyclododecane. (6) Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182, 16.7.1999, p. 1). (7) Council Decision 2003/33/EC of 19 December 2002 establishing criteria and procedures for the acceptance of waste at landfills pursuant to Article 16 of and Annex II to Directive 1999/31/EC (OJ L 11, 16.1.2003, p. 27). (8) The calculation method laid down in European standards EN 12766-1 and EN 12766-2 shall apply. ANNEX VI Repealed Regulation with list of the successive amendments thereto Regulation (EC) No 850/2004 of the European Parliament and of the Council (OJ L 158, 30.4.2004, p. 7) Council Regulation (EC) No 1195/2006 (OJ L 217, 8.8.2006, p. 1) Council Regulation (EC) No 172/2007 (OJ L 55, 23.2.2007, p. 1) Commission Regulation (EC) No 323/2007 (OJ L 85, 27.3.2007, p. 3) Regulation (EC) No 219/2009 of the European Parliament and of the Council (OJ L 87, 31.3.2009, p. 109) Only point 3.7 of the Annex Commission Regulation (EC) No 304/2009 (OJ L 96, 15.4.2009, p. 33) Commission Regulation (EU) No 756/2010 (OJ L 223, 25.8.2010, p. 20) Commission Regulation (EU) No 757/2010 (OJ L 223, 25.8.2010, p. 29) Commission Regulation (EU) No 519/2012 (OJ L 159, 20.6.2012, p. 1) Commission Regulation (EU) No 1342/2014 (OJ L 363, 18.12.2014, p. 67) Commission Regulation (EU) 2015/2030 (OJ L 298, 14.11.2015, p. 1) Commission Regulation (EU) 2016/293 (OJ L 55, 2.3.2016, p. 4) Commission Regulation (EU) 2016/460 (OJ L 80, 31.3.2016, p. 17) ANNEX VII CORRELATION TABLE Regulation (EC) No 850/2004 This Regulation Article 1(1) Article 1 Article 2, introductory wording Article 2, introductory wording Article 2, points (a) to (d) Article 2, points (1) to (4) — Article 2, points (5) to (7) Article 2, point (e) Article 2, point (8) Article 2, point (f) Article 2, point (9) Article 2, point (g) Article 2, point (10) — Article 2, points (11) to (13) Article 3 Article 3(1) to (3) — Article 3(4) and (5) Article 1(2) Article 3(6) Article 4(1) to (3) Article 4(1) to (3) — Article 4(3), point (d) Article 1(2) Article 4(4) Article 5 Article 5 Article 6 Article 6 Article 7(1) to (4) Article 7(1) to (4) Article 7(6) Article 7(5) — Article 7(6) Article 7(7) — — Article 8 Article 8 Article 9 Article 9 Article 10 Article 10 Article 11 Article 11 Article 12 Article 12(1) Article 13(1), point (a) Article 12(3), point (a) Article 13(1), point (b) Article 12(3), point (b) Article 13(1), point (c) — Article 13(1), point (d) Article 12(3), point (c) Article 13(1), point (e) Article 12(2) Article 13(1), point (f) — Article 13(2) Article 12(4) — Article 12(5) Article 13(3) Article 12(6) — — Article 13(4) and (5) Article 13 Article 14 Article 14 Article 15(1) Article 7(5) Article 15(2) — Article 16 — Article 17 — Article 18 Article 15 Article 19 Articles 16 and 17 Article 20 Article 18 — — Article 21 Article 19 Article 22 Annexes I to V Annexes I to V — Annex VI — Annex VII

Protecting health and the environment from persistent organic pollutants Protecting health and the environment from persistent organic pollutants SUMMARY OF: Regulation (EU) 2019/1021 on persistent organic pollutants WHAT IS THE AIM OF THE REGULATION? It aims to protect human health and the environment by eliminating, or restricting the production and use of persistent organic pollutants (POPs) as defined in the Stockholm Convention on Persistent Organic Pollutants or the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants. It seeks to minimise, or eliminate where possible, releases of such substances, and regulate waste containing or contaminated by them. The regulation particularly takes into account the precautionary principle. KEY POINTS POPs are potentially dangerous chemical substances which may cross international boundaries, are found often far from their emission sources, persist in the environment, bioaccumulate*, and consequently pose a threat to human health and the environment. Controls on manufacture, placing on the market*, and use The production and placing on the market of POPs listed in Annex I, whether on their own, in mixtures or in an article*, is banned. The production, placing on the market and use of POPs listed in Annex II is restricted to uses where locally safe, effective and affordable alternatives are not available to the country in question. EU countries and the European Commission must apply appropriate controls to existing substances (such as through listing) and prevent the production, placing on the market and use of any new substances which exhibit characteristics of POPs. EU countries may forward suggestions for listing to the Commission which, supported by the European Chemicals Agency (ECHA), decides whether to propose additional substances for listing. The ECHA also has a general advisory and informational role in the processes described in the regulation. Exemptions Exemptions from these controls are allowed for substances used for laboratory-scale research or as a reference standard, or which are present as an unintentional trace contaminant in mixtures or articles. Other exemptions apply to articles containing POPs manufactured prior to the regulation taking effect, subject to specific assurances and conditions, including requirements for notification to the Commission and the Stockholm Convention Secretariat. Release reduction, minimisation and elimination EU countries must: keep inventories of substances listed in Annex III released into air, water and land; communicate their action plans on measures to identify, characterise and minimise the release of substances, including the use of substitute or modified substances; give priority to alternative processes which avoid the formation and release of POPs when constructing or modifying facilities. Waste Those who produce or hold waste must avoid the waste being contaminated, as far as possible, with substances listed in Annex IV. In most cases, contaminated waste must be disposed of or recovered* quickly to ensure that the POP content is destroyed or transformed. EU countries must ensure that the production, collection and transportation of contaminated waste, as well as its storage and treatment, are traceable and carried out in conditions providing protection for the environment and human health. Planning, monitoring and reporting EU countries must give the public the opportunity to participate in this process and their implementation plans must be publicly available and shared with the Commission and the ECHA, including information on measures taken at national level to identify and assess sites contaminated by POPs, as appropriate. The Commission must also maintain an implementation plan which is to be reviewed and updated as appropriate. A monitoring mechanism must be established to gather comparable monitoring data on the presence of substances as listed in Part A of Annex III of the regulation in the environment. EU countries will also report on the implementation of the regulation. The Commission is empowered to adopt delegated acts to amend the list of substances in Annexes I, II and III of this regulation to adapt them to changes to the list of substances set out in the annexes to the Stockholm Convention or the 1979 Protocol. The regulation repeals and recasts Regulation (EC) No 850/2004. FROM WHEN DOES THE REGULATION APPLY? It has applied since 15 July 2019. BACKGROUND For more information, see: Persistent organic pollutants (POPs) (European Commission). KEY TERMS Bioaccumulate: become concentrated inside the bodies of living things. Placing on the market: supplying or making available, either in return for payment or free of charge, to a third party. Importing is also considered as ‘placing on the market’. Article: an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition. Waste recovery: defined in the Waste Framework Directive as any operation the principal result of which is waste serving a useful purpose by replacing other materials which would otherwise have been used to fulfil a particular function, or waste being prepared to fulfil that function, in the plant or in the wider economy. MAIN DOCUMENT Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (recast) (OJ L 169, 25.6.2019, pp. 45-77) RELATED DOCUMENTS Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, pp. 3-30) Successive amendments to Directive 2008/98/EC have been incorporated into the original text. This consolidated version is of documentary value only. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, pp. 1-849). Text republished in corrigendum (OJ L 136, 29.5.2007, pp. 3-280) See consolidated version. Communication from the Commission on the precautionary principle (COM(2000) 1 final, 2.2.2000) Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants (OJ L 81, 19.3.2004 pp. 37-71) last update 23.10.2019

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2.12.2020 EN Official Journal of the European Union L 405/1 REGULATION (EU) 2020/1783 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (recast) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 81(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Council Regulation (EC) No 1206/2001 (3) has been amended before. Since further substantial amendments are to be made, that Regulation should be recast in the interests of clarity. (2) The Union has set itself the objective of maintaining and developing the Union as an area of freedom, security and justice in which the free movement of persons is ensured. To establish such an area, the Union is to adopt, among other measures, measures relating to judicial cooperation in civil matters needed for the proper functioning of the internal market. (3) For the purposes of the proper functioning of the internal market and the development of an area of civil justice in the Union, it is necessary to further improve and expedite cooperation between the courts of the different Member States in relation to the taking of evidence. This Regulation seeks to improve the effectiveness and speed of judicial proceedings by simplifying and streamlining the mechanisms for cooperation in the taking of evidence in cross-border proceedings, while at the same time helping to reduce delays and costs for individuals and businesses. Providing greater legal certainty and simpler, streamlined and digitalised procedures will encourage individuals and businesses to engage in cross-border transactions, thereby boosting trade within the Union and thus the functioning of the internal market. (4) This Regulation lays down rules on cooperation between the courts of the different Member States in relation to the taking of evidence in civil or commercial matters. (5) For the purposes of this Regulation, the term ‘court’ should also be understood to mean authorities that exercise judicial functions, that act pursuant to a delegation of power by a judicial authority or that act under the control of a judicial authority, and that are competent under national law to take evidence for the purposes of judicial proceedings in civil or commercial matters. This includes in particular authorities that qualify as courts under other Union legal acts, such as Council Regulation (EU) 2019/1111 (4) and Regulations (EU) No 1215/2012 (5) and (EU) No 650/2012 (6) of the European Parliament and of the Council. (6) To ensure the utmost clarity and legal certainty, the request for the taking of evidence should be transmitted on a form completed in the language of the Member State of the requested court or in another language accepted by that Member State. For the same reasons, forms should also be used as much as possible for further communication between the relevant courts. (7) In order to ensure speedy transmission of requests and communications between Member States for the purposes of taking of evidence, any appropriate modern communications technology should be used. Therefore, as a rule, all communication and exchange of documents should be carried out through a secure and reliable decentralised IT system comprising national IT systems that are interconnected and technically interoperable, for example, and without prejudice to further technological progress, based on e-CODEX. Accordingly, a decentralised IT system should be established for data exchanges under this Regulation. The decentralised nature of that IT system would enable data exchanges exclusively between one Member State and another, without any of the Union institutions being involved in those exchanges. (8) Without prejudice to possible future technological progress, the secure decentralised IT system and its components should not be understood to necessarily constitute a qualified electronic registered delivery service as defined by Regulation (EU) No 910/2014 of the European Parliament and of the Council (7). (9) The Commission should be responsible for the creation, maintenance and future development of reference implementation software which Member States should be able to use instead of a national IT system, in accordance with the principles of data protection by design and by default. The Commission should design, develop and maintain the reference implementation software in compliance with the data protection requirements and principles laid down in Regulations (EU) 2018/1725 (8) and (EU) 2016/679 (9) of the European Parliament and of the Council, in particular the principles of data protection by design and by default. The reference implementation software should also include appropriate technical measures and enable the organisational measures necessary for ensuring a level of security and interoperability which is appropriate for the exchange of information in the context of the taking of evidence. (10) In relation to the components of the decentralised IT system which are under the responsibility of the Union, the managing entity should have sufficient resources in order to ensure the proper functioning of that system. (11) The competent authority or authorities under national law should be responsible as controllers within the meaning of Regulation (EU) 2016/679 in relation to the processing of personal data that they carry out under this Regulation for the transmission of requests and other communications between Member States. (12) Transmission through the decentralised IT system could become impossible due to a disruption of the system or the nature of the evidence, for example when transmitting DNA or blood samples. Other means of communication could be more appropriate also in exceptional circumstances, which could include situations in which converting voluminous documentation into electronic form would impose a disproportionate administrative burden on the competent authorities or whereby the original document is needed in paper format to assess its authenticity. Where the decentralised IT system is not used, transmission should be carried out by the most appropriate alternative means. Such alternative means should entail, inter alia, transmission being performed as swiftly as possible and in a secure manner by other secure electronic means or by postal service. (13) In order to enhance electronic cross-border transmission of documents through the decentralised IT system, such documents should not be denied legal effect and should not be considered inadmissible as evidence in the proceedings solely on the grounds that they are in electronic form. However, that principle should be without prejudice to the assessment of the legal effects or the admissibility of such documents as evidence in accordance with national law. It should also be without prejudice to national law regarding the conversion of documents. (14) This Regulation should be without prejudice to the ability of authorities to exchange information under systems established under other Union instruments, such as Regulation (EU) 2019/1111 or Council Regulation (EC) No 4/2009 (10), even where that information has evidentiary value, thus leaving the choice of the most appropriate method to the requesting authority. (15) Requests for the taking of evidence should be executed expeditiously. If it is not possible for a request to be executed within 90 days of its receipt by the requested court, the requested court should inform the requesting court accordingly, stating the reasons which prevent it from executing the request swiftly. (16) To ensure that this Regulation is effective, the circumstances in which it is possible to refuse to execute a request for the taking of evidence should be confined to strictly limited exceptional situations. (17) The requested court should execute a request for the taking of evidence in accordance with its national law. (18) The parties to the proceedings and their representatives, if any, should be able to be present at the taking of evidence, if that is provided for by the law of the Member State of the requesting court, in order to be able to follow the proceedings in a comparable way as if evidence were taken in the Member State of the requesting court. They should also have the right to request to participate in the taking of evidence in order to have a more active role in the taking of evidence. However, the conditions under which they may participate should be determined by the requested court in accordance with its national law. (19) The representatives of the requesting court should be able to be present at the taking of evidence, if that is compatible with the law of the Member State of the requesting court, in order to be in a better position to evaluate the evidence. They should also have the right to request to participate in the taking of evidence, under the conditions laid down by the requested court in accordance with its national law, in order to have a more active role in the taking of evidence. (20) In order to facilitate the taking of evidence, it should be possible for a court of a Member State, in accordance with its national law, to take evidence directly in another Member State, if the request for direct taking of evidence is accepted by the latter, and under the conditions determined by the central body or competent authority of the requested Member State. (21) Modern communications technology, for example videoconferencing, which is an important means of simplifying and accelerating the taking of evidence, is currently not used to its full potential. Where evidence is to be taken by examining a person such as a witness, a party to the proceedings or an expert present in another Member State, the requesting court should take that evidence directly using videoconferencing or other distance communications technology, where that technology is available to the court and the court considers the use of such technology to be appropriate with regard to the specific circumstances of the case and the fair conduct of the proceedings. Videoconferencing could also be used to hear a child as provided for in Regulation (EU) 2019/1111. However, where the central body or competent authority of the requested Member State deems certain conditions to be necessary, direct taking of evidence should be done under those conditions in accordance with the law of that Member State. The central body or competent authority of the requested Member State should be able to refuse the direct taking of evidence wholly or partially, if such direct taking of evidence would be contrary to fundamental principles of the law of that Member State. (22) Where evidence is to be taken by examining a person using videoconferencing or other distance communications technology, the requesting court, upon its request, should be provided with assistance in finding an interpreter, including in finding a certified interpreter where specifically requested. (23) The court seised of the proceedings should provide the parties and their legal representatives with instructions as to the procedure for presenting documents or other material when the examinations are conducted using videoconferencing or other appropriate distance communications technology. (24) In order to facilitate the taking of evidence by diplomatic agents or consular officers, such persons should be able to, in the territory of another Member State and within the area in which they are accredited, take evidence without the need for a prior request, by hearing, without the use of coercive measures, nationals of the Member State which they represent, in the context of proceedings pending in the courts of the Member State which they represent. However, it should be left to the discretion of the Member State whether its diplomatic agents or consular officers have the power to take evidence as part of their functions. (25) The taking of evidence by diplomatic agents or consular officers should take place at the premises of the diplomatic mission or consulate except in exceptional circumstances. Such circumstances could include the fact that the person to be heard is unable to come to the premises because of a serious illness. (26) The execution of a request for evidence to be taken in accordance with this Regulation should not give rise to a claim for reimbursement of taxes or costs. Nevertheless, if the requested court requires reimbursement, the fees paid to experts and interpreters, as well as the costs occasioned by execution in accordance with a special procedure provided for by national law or by the use of distance communications technology, should not be borne by that court. In such a case, the requesting court should take the necessary measures to ensure reimbursement without delay. Where the opinion of an expert is required, the requested court should be able, before executing the request, to ask the requesting court for an adequate deposit or advance towards the costs. (27) In order to update the forms in Annex I to this Regulation or to make technical changes to those forms, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amendments to that Annex. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (11). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (28) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (12). (29) This Regulation should prevail over the provisions contained in bilateral or multilateral agreements or arrangements concluded by the Member States that have the same scope of application as this Regulation. This Regulation does not preclude Member States from maintaining or concluding agreements or arrangements to further facilitate cooperation in the taking of evidence, provided that those agreements or arrangements are compatible with this Regulation. (30) It is essential that effective means of obtaining, preserving and presenting evidence are available and that rights of defence are respected and confidential information is protected. In this context, it is important to encourage the use of modern technology. (31) The procedures for taking, preserving and presenting evidence should ensure that procedural rights, as well as privacy and the integrity and confidentiality of personal data, are protected in accordance with Union and national law. (32) It is important to ensure that this Regulation is applied in compliance with Union data protection law and that the application of this Regulation respects the protection of privacy as enshrined in the Charter of Fundamental Rights of the European Union. It is also important to ensure that any processing of personal data under this Regulation is undertaken in accordance with Regulation (EU) 2016/679, Directive 2002/58/EC of the European Parliament and of the Council (13), as well as Regulation (EU) 2018/1725. Personal data should be processed under this Regulation only for the specific purposes set out herein. (33) In accordance with paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, the Commission should evaluate this Regulation on the basis of information collected through specific monitoring arrangements in order to assess the actual effects of this Regulation and the need for any further action. Where Member States collect data on the numbers of requests transmitted and requests executed, as well as the number of cases in which transmission was performed by means other than through the decentralised IT system, they should provide the Commission with such data for monitoring purposes. The reference implementation software developed by the Commission as a back-end system should programmatically collect the data necessary for monitoring purposes and such data should be transmitted to the Commission. Where Member States choose to use a national IT system instead of the reference implementation software developed by the Commission that system may be equipped to programmatically collect those data and in that case those data should be transmitted to the Commission. (34) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of the creation of a simplified legal framework ensuring the direct, effective and speedy transmission of requests and communications concerning the taking of evidence, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (35) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an opinion on 13 September 2019 (14). (36) In order to make its provisions more easily accessible and readable, Regulation (EC) No 1206/2001 should be repealed and replaced by this Regulation. (37) In accordance with Article 3 and Article 4a(1) of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Ireland has notified its wish to take part in the adoption and application of this Regulation. (38) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Scope 1. This Regulation applies in civil or commercial matters in which the court of a Member State, in accordance with the law of that Member State, requests: (a) the competent court of another Member State to take evidence; or (b) the taking of evidence directly in another Member State. 2. A request shall not be made to obtain evidence which is not intended for use in judicial proceedings that have already commenced or are being contemplated. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘court’ means courts and other authorities in Member States as communicated to the Commission under Article 31(3), that exercise judicial functions, that act pursuant to a delegation of power by a judicial authority or that act under the control of a judicial authority, and which are competent under national law to take evidence for the purposes of judicial proceedings in civil or commercial matters; (2) ‘decentralised IT system’ means a network of national IT systems and interoperable access points operating under the individual responsibility and management of each Member State, that enables the secure and reliable cross-border exchange of information between the national IT systems. Article 3 Direct transmission between courts 1. Requests referred to in point (a) of Article 1(1) shall be transmitted by the court before which the proceedings are commenced or contemplated (‘requesting court’), directly to the competent court of another Member State (‘requested court’), for the taking of evidence. 2. Each Member State shall draw up a list of the courts competent to take evidence in accordance with this Regulation. The list shall also indicate the territorial and, where applicable, the special jurisdiction of those courts. Article 4 Central body 1. Each Member State shall designate a central body that is responsible for: (a) supplying information to the courts; (b) seeking solutions to any difficulties which may arise in respect of a request; (c) forwarding, in exceptional cases, a request to the competent court at the request of a requesting court. 2. Federal Member States, Member States in which several legal systems apply and Member States with autonomous territorial units shall be free to designate more than one central body. 3. Each Member State shall also designate the central body referred to in paragraph 1 of this Article or one or more competent authorities to be responsible for taking decisions on requests made pursuant to Article 19. CHAPTER II TRANSMISSION AND EXECUTION OF REQUESTS SECTION 1 Transmission of requests Article 5 Form and content of requests 1. Requests shall be made using form A or, where appropriate, form L in Annex I. Each request shall contain the following details: (a) the requesting and, where appropriate, the requested court; (b) the names and addresses of the parties to the proceedings and their representatives, if any; (c) the nature and subject matter of the case and a brief statement of the facts; (d) a description of the taking of evidence requested; (e) where the request is for the examination of a person: — the name and address of the person to be examined, — the questions to be put to the person to be examined or a statement of the facts about which that person is to be examined, — where appropriate, a reference to the right to refuse to testify under the law of the Member State of the requesting court, — any requirement that the examination be carried out under oath or affirmation instead of an oath, and any special form to be used for such oath or affirmation, — where appropriate, any other information that the requesting court deems necessary; (f) where the request is for any form of taking of evidence other than that mentioned in point (e), the documents or other objects to be inspected; (g) where appropriate, any request pursuant to Article 12(3) or (4), or Article 13 or 14 and any information necessary for the execution thereof. 2. The request and all accompanying documents shall be exempt from the need for authentication or any equivalent formality. 3. Documents which the requesting court considers necessary to enclose for the execution of the request shall be accompanied by a translation of the documents in the language in which the request was written. Article 6 Language Requests and communications made pursuant to this Regulation shall be drawn up in the official language of the requested Member State or, if there are several official languages in that Member State, in the official language or one of the official languages of the place where the requested taking of evidence is to take place, or in another language which that Member State has indicated it will accept. Each Member State shall communicate to the Commission any official language of the Union other than its own in which the forms set out in Annex I may be completed. Article 7 Transmission of requests and other communications 1. Requests and communications made pursuant to this Regulation shall be transmitted through a secure and reliable decentralised IT system with due respect for fundamental rights and freedoms. That decentralised IT system shall be based on an interoperable solution such as e-CODEX. 2. The general legal framework for the use of qualified trust services set out in Regulation (EU) No 910/2014 shall apply to the requests and communications transmitted through the decentralised IT system. 3. Where requests and communications referred to in paragraph 1 of this Article require or feature a seal or handwritten signature, qualified electronic seals or qualified electronic signatures as defined in Regulation (EU) No 910/2014 may be used instead. 4. Where transmission in accordance with paragraph 1 is not possible due to the disruption of the decentralised IT system or to the nature of the evidence concerned, or due to exceptional circumstances, the transmission shall be carried out by the swiftest, most appropriate alternative means, taking into account the need to ensure reliability and security. Article 8 Legal effects of electronic documents Documents that are transmitted through the decentralised IT system shall not be denied legal effect or considered inadmissible as evidence in the proceedings solely on the grounds that they are in electronic form. SECTION 2 Receipt of requests Article 9 Receipt of requests 1. Within 7 days of the receipt of a request, the requested competent court shall send an acknowledgement of receipt to the requesting court using form B in Annex I. Where the request does not comply with the conditions laid down in Articles 6 and 7, the requested court shall enter a note to that effect in the acknowledgement of receipt. 2. Where the requested court does not have jurisdiction to execute a request, made using form A in Annex I, which complies with the conditions laid down in Article 6, that court shall forward the request to the competent court of its Member State and shall inform the requesting court thereof using form C in Annex I. Article 10 Incomplete requests 1. If a request cannot be executed because it does not contain all of the necessary information referred to in Article 5, the requested court shall inform the requesting court thereof without delay and, at the latest, within 30 days of receipt of the request using form D in Annex I, and shall request the requesting court to send the missing information, specifying the information missing as precisely as possible. 2. If a request cannot be executed because a deposit or advance has been requested in accordance with Article 22(3), the requested court shall inform the requesting court thereof without delay, at the latest within 30 days of receipt of the request using form D in Annex I, and shall inform the requesting court how the deposit or advance is to be made. The requested court shall acknowledge receipt of the deposit or advance without delay, at the latest within 10 days of receiving the deposit or the advance, using form E in Annex I. Article 11 Completion of the request 1. If the requested court has noted on the acknowledgement of receipt pursuant to Article 9(1) that the request does not comply with the conditions laid down in Articles 6 and 7 or has informed the requesting court pursuant to Article 10 that the request cannot be executed because it does not contain all of the necessary information referred to in Article 5, the time limit laid down in Article 12 shall begin to run when the requested court has received the duly completed request. 2. Where the requested court has asked for a deposit or advance in accordance with Article 22(3), the time limit laid down in Article 12 shall begin to run when the deposit or the advance is made. SECTION 3 Taking of evidence by the requested court Article 12 General provisions on the execution of a request 1. The requested court shall execute the request without delay and, at the latest, within 90 days of receipt of the request. 2. The requested court shall execute the request in accordance with its national law. 3. The requesting court may call for the request to be executed in accordance with a special procedure provided for in its national law, using form A in Annex I. The requested court shall execute the request in accordance with the special procedure unless doing so would be incompatible with its national law or it is unable to do so because of major practical difficulties. If the requested court does not comply with the call for the request to be executed in accordance with a special procedure for one of those reasons, it shall inform the requesting court using form H in Annex I. 4. The requesting court may ask the requested court to use specific communications technology in the taking of evidence, in particular by using videoconferencing or teleconferencing. The requested court shall use the communications technology specified pursuant to the first subparagraph unless doing so would be incompatible with its national law or the requested court is unable to do so because of major practical difficulties. If the requested court does not use the specified communications technology for one of those reasons, it shall inform the requesting court using form H in Annex I. If the communications technology referred to in the first subparagraph is not available in the requesting or in the requested court, those courts may make such communications technology available by mutual agreement. Article 13 Taking of evidence with the presence and participation of the parties 1. If the law of the Member State of the requesting court so provides, the parties and their representatives, if any, shall have the right to be present at the taking of evidence by the requested court. 2. In its request, the requesting court shall inform the requested court, using form A in Annex I, that the parties and their representatives, if any, will be present and, where appropriate, that their participation in the taking of evidence is requested. This information may also be given at any other appropriate time. 3. If the participation of the parties and their representatives, if any, is requested in the taking of evidence, the requested court shall determine the conditions under which they may participate, in accordance with Article 12. 4. The requested court shall notify the parties and their representatives, if any, of the time and the place where the taking of evidence will take place and, where appropriate, of the conditions under which they may participate in the taking of evidence, using form I in Annex I. 5. Paragraphs 1 to 4 are without prejudice to the ability of the requested court to request the parties and their representatives, if any, to be present at or to participate in the taking of evidence if provided for by the law of its Member State. Article 14 Taking of evidence with the presence and participation of representatives of the requesting court 1. Where compatible with the law of the Member State of the requesting court, representatives of the requesting court shall have the right to be present in the taking of evidence by the requested court. 2. For the purposes of this Article, the term ‘representative’ includes judicial personnel designated by the requesting court in accordance with its national law. The requesting court may also designate any other person, such as an expert, in accordance with its national law. 3. In its request, the requesting court shall inform the requested court, using form A in Annex I, that its representatives will be present and, where appropriate, that their participation in the taking of evidence is requested. This information may also be given at any other appropriate time. 4. If the participation of the representatives of the requesting court is requested in the taking of evidence, the requested court shall determine, in accordance with Article 12, the conditions under which they may participate. 5. The requested court shall notify the requesting court of the time and the place where the taking of evidence will take place and, where appropriate, of the conditions under which its representatives may participate in the taking of evidence, using form I in Annex I. Article 15 Coercive measures Where necessary, in executing a request the requested court shall apply the appropriate coercive measures in the instances and to the extent as are provided for by the law of the Member State of the requested court for the execution of a request made for the same purpose by its national authorities or one of the parties concerned. Article 16 Refusals to execute requests 1. A request for the examination of a person shall not be executed where the person concerned invokes the right to refuse to give evidence or is prohibited from giving evidence: (a) under the law of the Member State of the requested court; or (b) under the law of the Member State of the requesting court, and such right or prohibition has been specified in the request, or, if necessary, at the instance of the requested court, has been confirmed by the requesting court. 2. The execution of a request may only be refused on grounds other than those referred to in paragraph 1, where one or more of the following grounds applies: (a) the request does not fall within the scope of this Regulation; (b) the execution of the request does not fall within the functions of the judiciary under the law of the Member State of the requested court; (c) the requesting court does not comply with the request of the requested court to complete the request for the taking of evidence pursuant to Article 10 within 30 days of the requested court asking it to do so; or (d) a deposit or advance asked for in accordance with Article 22(3) is not made within 60 days of the requested court asking for such a deposit or advance. 3. A requested court shall not refuse to execute a request solely on the ground that under its national law another court of that Member State has exclusive jurisdiction over the subject matter of the case or that the law of that Member State would not admit the right of action on the subject matter. 4. If the execution of a request is refused on one of the grounds referred to in paragraph 2, the requested court shall notify the requesting court thereof within 60 days of receipt of the request by the requested court using form K in Annex I. Article 17 Notification of delay If the requested court is not in a position to execute the request within 90 days of receipt of the request, it shall inform the requesting court thereof using form J in Annex I. When it does so, it shall give the grounds for the delay as well as the estimated time it expects it will need to execute the request. Article 18 Procedure after the execution of the request The requested court shall send to the requesting court the documents confirming the execution of the request, without delay and, where appropriate, shall return the documents received from the requesting court. Those documents shall be accompanied by a confirmation of execution using form K in Annex I. SECTION 4 Direct taking of evidence by the requesting court and taking of evidence by diplomatic agents or consular officers Article 19 Direct taking of evidence by the requesting court 1. Where a court requests the taking of evidence directly in another Member State, it shall submit a request to the central body or to the competent authority of that Member State, using form L in Annex I. 2. The direct taking of evidence may only take place if it can be carried out on a voluntary basis without the use of coercive measures. Where the direct taking of evidence implies that a person has to be examined, the requesting court shall inform that person that the taking of evidence shall take place on a voluntary basis. 3. The direct taking of evidence shall be carried out by a member of the judicial personnel or by any other person, such as an expert, who is designated in accordance with the law of the Member State of the requesting court. 4. Within 30 days of receiving the request for the direct taking of evidence, the central body or the competent authority of the requested Member State shall inform the requesting court as to whether the request has been accepted and, if necessary, shall inform the requesting court of the conditions under which the direct taking of evidence is to be carried out according to the law of its Member State, using form M in Annex I. The central body or the competent authority may assign a court of its Member State to take part in the direct taking of evidence in order to ensure that this Article is properly applied and that the conditions under which the direct taking of evidence is to be carried out are complied with. 5. Where the requesting court has not received information within 30 days of acknowledgement of receipt of the request for the direct taking of evidence as to whether the request has been accepted, it may send a reminder to the central body or competent authority of the requested Member State. If the requesting court does not receive a reply within 15 days of the acknowledgement of receipt of the reminder, the request for the direct taking of evidence shall be considered accepted. However, in extraordinary circumstances where the central body or competent authority was prevented from reacting to the request within the deadline following the reminder, grounds for the refusal of direct taking of evidence may exceptionally still be invoked at any time after the expiration of that deadline until the moment of the actual direct taking of evidence. 6. The central body or the competent authority of the requested Member State may assign a court of its Member State to provide practical assistance in the direct taking of evidence. 7. The central body or the competent authority of the requested Member State may refuse a request for direct taking of evidence only if: (a) it does not fall within the scope of this Regulation; (b) it does not contain all of the necessary information referred to in Article 5; or (c) the direct taking of evidence requested is contrary to fundamental principles of law in its Member State. 8. Without prejudice to any conditions laid down in accordance with paragraph 4, the requesting court shall conduct the direct taking of evidence in accordance with the law of its Member State. Article 20 Direct taking of evidence by videoconferencing or other distance communications technology 1. Where evidence is to be taken by examining a person who is present in another Member State, and the court requests the taking of evidence directly in accordance with Article 19, that court shall take evidence using videoconferencing or other distance communications technology provided that such technology is available to the court and the court considers the use of such technology to be appropriate in the specific circumstances of the case. 2. A request for the direct taking of evidence using videoconferencing or other distance communications technology shall be made using form N in Annex I. The requesting court and the central body or the competent authority of the requested Member State or the court assigned to provide practical assistance in the direct taking of evidence shall agree on the practical arrangements for the examination. Upon request, the requesting court shall be provided with assistance in finding an interpreter if necessary. Article 21 Taking of evidence by diplomatic agents or consular officers Member States may provide in their national law for their courts to be able to request their diplomatic agents or consular officers in the territory of another Member State and within the area in which they are accredited to take evidence at the premises of the diplomatic mission or consulate, except in exceptional circumstances, without the need for a prior request, by hearing, on a voluntary basis and without the use of coercive measures, nationals of the Member State which they represent in the context of proceedings pending in the courts of the Member State which they represent. The requested diplomatic agent or consular officer shall execute the request in accordance with the law of his or her Member State. SECTION 5 Costs Article 22 Costs 1. The execution of a request for the taking of evidence in accordance with Article 12 shall not give rise to any claim for the reimbursement of taxes or costs. 2. By way of derogation from paragraph 1, the requested court may require the reimbursement of taxes or costs. If the requested court so requires, the requesting court shall ensure that the following are reimbursed without delay: — the fees paid to experts and interpreters, and — the costs occasioned by the application of Article 12(3) and (4). The obligation of the parties to bear such fees or costs shall be governed by the law of the Member State of the requesting court. 3. Where the opinion of an expert is required, before executing the request for the taking of evidence, the requested court may ask the requesting court for an adequate deposit or advance towards the anticipated costs of the expert opinion. In all other cases, a deposit or advance shall not be a condition for the execution of a request for the taking of evidence. The deposit or advance shall be made by the parties if that is provided for by the law of the Member State of the requesting court. CHAPTER III FINAL PROVISIONS Article 23 Manual and amendment of Annex I 1. The Commission shall draw up and regularly update a manual containing the information provided by the Member States in accordance with Article 31 and the agreements or arrangements in force, in accordance with Article 29(3). It shall make the manual available electronically, in particular through the European Judicial Network in Civil and Commercial Matters and on the European e-Justice Portal. 2. The Commission is empowered to adopt delegated acts in accordance with Article 24 to amend Annex I in order to update the forms set out therein or to make technical changes to those forms. Article 24 Exercise of delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 23(2) shall be conferred on the Commission for a period of 5 years from 22 December 2020. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 23(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 23(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council. Article 25 Adoption of implementing acts by the Commission 1. The Commission shall adopt implementing acts establishing the decentralised IT system, setting out the following: (a) the technical specification defining the methods of communication by electronic means for the purposes of the decentralised IT system; (b) the technical specifications for communication protocols; (c) the information security objectives and relevant technical measures ensuring minimum information security standards for the processing and communication of information within the decentralised IT system; (d) the minimum availability objectives and possible related technical requirements for the services provided by the decentralised IT system; (e) the establishment of a steering committee comprising representatives of the Member States to ensure the operation and maintenance of the decentralised IT system in order to meet the objectives of this Regulation. 2. The implementing acts referred to in paragraph 1 of this Article shall be adopted by 23 March 2022 in accordance with the examination procedure referred to in Article 26(2). Article 26 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 27 Reference implementation software 1. The Commission shall be responsible for the creation, maintenance and future development of reference implementation software which Member States may choose to apply as their back-end system instead of a national IT system. The creation, maintenance and future development of the reference implementation software shall be financed from the general budget of the Union. 2. The Commission shall provide, maintain and support on a free-of-charge basis implementation of the software components underlying the access points. Article 28 Costs of the decentralised IT system 1. Each Member State shall bear the costs of the installation, operation and maintenance of its access points interconnecting the national IT systems in the context of the decentralised IT system. 2. Each Member State shall bear the costs of establishing and adjusting its national IT systems to make them interoperable with the access points, and shall bear the costs of administering, operating and maintaining those systems. 3. Paragraphs 1 and 2 shall be without prejudice to the possibility of Member States to apply for grants to support the activities referred to in those paragraphs under the Union’s financial programmes. Article 29 Relationship with agreements or arrangements between Member States 1. This Regulation shall prevail in relation to matters to which it applies over other provisions contained in bilateral or multilateral agreements or arrangements concluded by the Member States, and in particular the Hague Convention of 1 March 1954 on Civil Procedure and the Hague Convention of 18 March 1970 on the Taking of Evidence Abroad in Civil or Commercial Matters, in relations between the Member States party thereto. 2. This Regulation shall not preclude Member States from maintaining or concluding agreements or arrangements to further facilitate the taking of evidence, provided that those agreements or arrangements are compatible with this Regulation. 3. Member States shall send to the Commission: (a) a copy of any agreements or arrangements referred to in paragraph 2 concluded between the Member States, as well as drafts of any such agreements or arrangements which they intend to adopt; and (b) any denunciation of, or amendments to, those agreements or arrangements. Article 30 Protection of information transmitted 1. Any processing of personal data carried out pursuant to this Regulation, including the exchange or transmission of personal data by the competent authorities, shall be in conformity with Regulation (EU) 2016/679. Any exchange or transmission of information by competent authorities at Union level shall be undertaken in accordance with Regulation (EU) 2018/1725. Personal data which are not relevant for the handling of a specific case shall be deleted immediately. 2. The competent authority or authorities under national law shall be regarded as controllers within the meaning of Regulation (EU) 2016/679 with respect to personal data processing under this Regulation. 3. Notwithstanding paragraphs 1 and 2, information transmitted under this Regulation shall be used by the requested court only for the purpose for which it was transmitted. 4. Requested courts shall ensure that such information remains confidential, in accordance with their national law. 5. Paragraphs 3 and 4 shall be without prejudice to national laws enabling data subjects to be informed of the use made of information transmitted under this Regulation. 6. This Regulation shall be without prejudice to Directive 2002/58/EC. Article 31 Communication 1. Member States shall communicate to the Commission the following: (a) the list drawn up pursuant to Article 3(2) indicating the territorial and, where applicable, the special jurisdiction of the courts; (b) the names and addresses of the central bodies and competent authorities designated pursuant to Article 4(3), indicating their territorial jurisdiction; (c) the technical means for the receipt of requests available to the courts on the list drawn up pursuant to Article 3(2); (d) the languages accepted for requests, as referred to in Article 6. 2. Member States shall inform the Commission of any subsequent changes to the information referred to in paragraph 1. 3. Each Member State shall communicate to the Commission details of the other authorities that are competent to take evidence for the purposes of judicial proceedings in civil or commercial matters. Member States shall inform the Commission of any subsequent changes to those details. 4. Member States may notify the Commission if they are in a position to operate the decentralised IT system earlier than required by this Regulation. The Commission shall make such information available electronically, in particular through the European e-Justice Portal. Article 32 Monitoring 1. By 2 July 2023, the Commission shall establish a detailed programme for monitoring the outputs, results and impact of this Regulation. 2. The monitoring programme shall specify the action to be taken by the Commission and by the Member States to monitor the outputs, results and impact of this Regulation. It shall set out when the data referred to in paragraph 3 are to be collected for the first time, which shall be at the latest 2 July 2026, and at what further intervals those data are to be collected. 3. Member States shall provide the Commission with the following data necessary for the purposes of monitoring, where available: (a) the number of requests for the taking of evidence transmitted in accordance with Article 7(1) and Article 19(1) respectively; (b) the number of requests for the taking of evidence executed in accordance with Article 12 and Article 19(8) respectively; (c) the number of cases in which the request for the taking of evidence was transmitted by means other than through the decentralised IT system in accordance with Article 7(4). 4. The reference implementation software and, where equipped to do so, the national back-end system shall programmatically collect the data referred to in points (a) and (b) of paragraph 3 and transmit them to the Commission on a regular basis. Article 33 Evaluation 1. No later than 5 years after the date of application of Article 7 in accordance with Article 35(3), the Commission shall carry out an evaluation of this Regulation and present a report on its main findings to the European Parliament, the Council and the European Economic and Social Committee, accompanied, where appropriate, by a legislative proposal. 2. Member States shall provide the Commission with the information necessary for the preparation of the report referred to in paragraph 1. Article 34 Repeal 1. Regulation (EC) No 1206/2001 shall be repealed as from the date of application of this Regulation, with the exception of Article 6 of Regulation (EC) No 1206/2001 which shall be repealed as from the date of application of Article 7 referred to in Article 35(3) of this Regulation. 2. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex III. Article 35 Entry into force and application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 July 2022. 2. Article 31(3) shall apply from 23 March 2022. 3. Article 7 shall apply from the first day of the month following the period of 3 years after the date of entry into force of the implementing acts referred to in Article 25. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Brussels, 25 November 2020. For the European Parliament The President D.M. SASSOLI For the Council The President M. ROTH (1) OJ C 62, 15.2.2019, p. 56. (2) Position of the European Parliament of 13 February 2019 (not yet published in the Official Journal) and position of the Council at first reading of 4 November 2020 (not yet published in the Official Journal). Position of the European Parliament of 23 November 2020 (not yet published in the Official Journal). (3) Council Regulation (EC) No 1206/2001 of 28 May 2001 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (OJ L 174, 27.6.2001, p. 1). (4) Council Regulation (EU) 2019/1111 of 25 June 2019 on jurisdiction, the recognition and enforcement of decisions in matrimonial matters and the matters of parental responsibility, and on international child abduction (OJ L 178, 2.7.2019, p. 1). (5) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). (6) Regulation (EU) No 650/2012 of the European Parliament and of the Council of 4 July 2012 on jurisdiction, applicable law, recognition and enforcement of decisions and acceptance and enforcement of authentic instruments in matters of succession and on the creation of a European Certificate of Succession (OJ L 201, 27.7.2012, p. 107). (7) Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73). (8) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (9) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (10) Council Regulation (EC) No 4/2009 of 18 December 2008 on jurisdiction, applicable law, recognition and enforcement of decisions and cooperation in matters relating to maintenance obligations (OJ L 7, 10.1.2009, p. 1). (11) OJ L 123, 12.5.2016, p. 1. (12) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (13) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37). (14) OJ C 370, 31.10.2019, p. 24. ANNEX I FORM A REQUEST FOR THE TAKING OF EVIDENCE (Article 5 of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (1)) 1. Reference No of the requesting court: 2. Requesting court: 2.1. Name: 2.2. Address: 2.2.1. Street and number/PO box: 2.2.2. Place and postcode: 2.2.3. Country: 2.3. Tel. 2.4. Fax ((*)): 2.5. Email: 3. Requested court: 3.1. Name: 3.2. Address: 3.2.1. Street and number/PO box: 3.2.2. Place and postcode: 3.2.3. Country: 3.3. Tel. 3.4. Fax ((*)): 3.5. Email: 4. In the case brought by the claimant/petitioner(s) (2) 4.1. Name: 4.2. Address: 4.2.1. Street and number/PO box: 4.2.2. Place and postcode: 4.2.3. Country: 4.3. Tel. ((*)): 4.4. Fax ((*)): 4.5. Email ((*)): 5. Representatives of the claimant/petitioner 5.1. Name: 5.2. Address: 5.2.1. Street and number/PO box: 5.2.2. Place and postcode: 5.2.3. Country: 5.3. Tel. 5.4. Fax ((*)): 5.5. Email: 6. Against the defendant/respondent(s) (3) 6.1. Name: 6.2. Address: 6.2.1. Street and number/PO box: 6.2.2. Place and postcode: 6.2.3. Country: 6.3. Tel. ((*)): 6.4. Fax ((*)): 6.5. Email ((*)): 7. Representatives of defendant/respondent 7.1. Name: 7.2. Address: 7.2.1. Street and number/PO box: 7.2.2. Place and postcode: 7.2.3. Country: 7.3. Tel. 7.4. Fax ((*)): 7.5. Email: 8. Presence and participation of the parties 8.1. Parties and representatives, if any, who will be present at the taking of evidence: ☐ 8.2. Participation of the parties and of their representatives, if any, is requested: ☐ 8.3. If any party or its representative will be present at the taking of evidence, interpretation in the following language is to be arranged: ☐ BG, ☐ ES, ☐ CZ, ☐ DE, ☐ ET, ☐ EL, ☐ EN, ☐ FR, ☐ GA, ☐ HR, ☐ IT, ☐ LV, ☐ LT, ☐ HU, ☐ MT, ☐ NL, ☐ PL, ☐ PT, ☐ RO, ☐ SK, ☐ SL, ☐ FI, ☐ SV, ☐ other: 9. Presence and participation of the representatives of the requesting court: ☐ 9.1. Representatives will be present at the taking of evidence: ☐ 9.2. Participation of the representatives is requested: (4) ☐ 9.2.1. Name: 9.2.2. Title: 9.2.3. Function: 9.2.4. Task: 9.3. If any representative of the requesting court will be present at the taking of evidence, interpretation in the following language is to be arranged: ☐ BG, ☐ ES, ☐ CZ, ☐ DE, ☐ ET, ☐ EL, ☐ EN, ☐ FR, ☐ GA, ☐ HR, ☐ IT, ☐ LV, ☐ LT, ☐ HU, ☐ MT, ☐ NL, ☐ PL, ☐ PT, ☐ RO, ☐ SK, SL, ☐ FI, ☐ SV, ☐ other: 10. Nature and subject-matter of the case and a brief statement of the facts (in annex, where appropriate): 11. Taking of evidence to be carried out 11.1. Description of the taking of evidence to be carried out (in annex, where appropriate): 11.2. Examination of witnesses: ☐ 11.2.1. Name and surname: 11.2.2. Date of birth, if available: 11.2.3. Address: 11.2.3.1. Street and number/PO box: 11.2.3.2. Place and postcode: 11.2.3.3. Country: 11.2.4. Tel. ((*)): 11.2.5. Fax ((*)): 11.2.6. Email ((*)): 11.2.7. Questions to be put to the witness or a statement of the facts about which they are to be examined (in annex, where appropriate): 11.2.8. Right to refuse to testify under the law of the Member State of the requesting court (in annex, where appropriate): yes ☐ no ☐ 11.2.9. Please examine the witness 11.2.9.1. under oath: ☐ 11.2.9.2. on affirmation: ☐ 11.2.10. Any other information that the requesting court deems necessary (in annex, where appropriate): 11.3. Other taking of evidence 11.3.1. documents to be inspected and a description of the requested taking of evidence (in annex, where appropriate): 11.3.2. objects to be inspected and a description of the requested taking of evidence (in annex, where appropriate) 12. Please execute the request 12.1. in accordance with a special procedure (Article 12(3) of Regulation (EU) 2020/1783) provided for by the law of the Member State of the requesting court described in annex ☐ 12.2. and/or by the use of communications technology (Article 12(4) of Regulation (EU) 2020/1783) set out in form N ☐ 12.3. the following information is necessary for the execution of the request: 13. Reasons for not transmitting through the decentralised IT system (Article 7(4) of Regulation (EU) 2020/1783) (5) Electronic transmission was not possible due to: ☐ disruption of the decentralised IT system ☐ the nature of the evidence ☐ exceptional circumstances Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: FORM B ACKNOWLEDGEMENT OF RECEIPT OF A REQUEST FOR THE TAKING OF EVIDENCE (Article 9(1) of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (6)) 1. Reference No of the requesting court: 2. Reference No of the requested court: 3. Name of the requesting court: 4. Requested court 4.1. Name: 4.2. Address: 4.3. Tel. 4.4. Fax ((*)): 4.5. Email: 5. The request was received on … (date of receipt) by the court indicated in item 4. 6. The request cannot be dealt with because: 6.1. The language used to complete the form is not accepted (Article 6 of Regulation (EU) 2020/1783): ☐ 6.1.1. Please use one the following languages: 6.2. The document is not legible: ☐ Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal FORM C NOTIFICATION OF FORWARDING OF A REQUEST FOR THE TAKING OF EVIDENCE (Article 9(2) of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence (7)) 1. Reference No of the requesting court: 2. Name of the requesting court: 3. Reference No of the requested court: 4. The request for the taking of evidence does not fall within the jurisdiction of the court indicated in item 3 of the request for the taking of evidence and was forwarded to 4.1. Name of the competent court: 4.2. Address: 4.2.1. Street and number/PO box: 4.2.2. Place and postcode: 4.2.3. Country: 4.3. Tel. 4.4. Fax ((*)): 4.5. Email: Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: FORM D REQUEST FOR ADDITIONAL INFORMATION FOR THE TAKING OF EVIDENCE (Article 10 of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (8)) 1. Reference No of the requested court: 2. Reference No of the requesting court: 3. Name of the requested court: 4. Name of the requesting court: 5. The request for the taking of evidence cannot be executed without the following additional information: 6. The request for the taking of evidence cannot be executed before a deposit or advance is made in accordance with Article 22(3) of Regulation (EU) 2020/1783. The deposit or advance should be made in the following way: 6.1. Name of account owner: 6.2. Bank name/BIC or other relevant bank code: 6.3. Account number/IBAN: 6.4. Date by which payment was due: 6.5. Amount of the deposit or advance requested: 6.6. Currency: ☐ Euro (EUR) ☐ Bulgarian lev (BGN) ☐ Croatian kuna (HRK) ☐ Czech koruna (CZK) ☐ Hungarian forint (HUF) ☐ Polish zloty (PLN) ☐ Pound sterling (GBP) ☐ Romanian leu (RON) ☐ Swedish krona (SEK) ☐ Other (please specify (ISO code)): 6.7. Reference number of payment/description/message to the recipient: Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: FORM E ACKNOWLEDGEMENT OF RECEIPT OF DEPOSIT OR ADVANCE (Article 10(2) of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (9)) 1. Reference No of the requesting court: 2. Reference No of the requested court: 3. Name of the requesting court: 4. Name of the requested court: 5. The deposit or advance was received on … (date of receipt) by the court indicated in item 4. Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: FORM F (10) REQUEST FOR INFORMATION ON DELAY (Article 12(1) and Article 19(4) of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence (11)) THE FOLLOWING REQUEST FOR THE TAKING OF EVIDENCE WAS SENT BUT NO INFORMATION ON THE OUTCOME OF THE TAKING OF EVIDENCE IS AVAILABLE 1. Reference No of the requesting court: 2. Reference No of the requested court/central body/competent authority (if available): 3. Name of the requesting court: 4. Name of the requested court/central body/competent authority: 5. The original request for the taking of evidence (form A) or original request for the direct taking of evidence (form L) is attached. ☐ Information at disposal of the requesting court: 5.1. request sent ☐ date ............................................... 5.2. acknowledgement of receipt ☐ date ............................................... 5.3. notification of delay ☐ date ............................................... 5.4. other information was received ☐ .................................................................. Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: FORM G (12) REPLY TO REQUEST FOR INFORMATION ON DELAY (Article 12(1) of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (13)) 1. Reference No of the requesting court: 2. Reference No of the requested court/central body/competent authority (if available): 3. Name of the requesting court: 4. Name of the requested court/central body/competent authority: 5. THE DELAY WAS DUE TO: 5.1. Request for taking of evidence was not received ☐ 5.2. Determination of current address of the person to be examined is in progress ☐ 5.3. Service of summons to the person to be examined is in progress ☐ 5.4. Person did not appear at the hearing despite being served the summons ☐ 5.5. Request replied to on … (date). Reply attached ☐ 5.6. Payment of a deposit or advance requested on … (date) has not been received ☐ 5.7. Other: … ☐ 6. It is estimated that the request will be executed by … (indicate an estimated date). Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: FORM H NOTIFICATION CONCERNING THE REQUEST FOR SPECIAL PROCEDURES AND/OR FOR THE USE OF COMMUNICATIONS TECHNOLOGIES (Article 12(3) and (4) of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (14)) 1. Reference No of the requesting court: 2. Reference No of the requested court: 3. Name of the requesting court: 4. Name of the requested court: 5. The call for execution of the request for the taking of evidence in accordance with the special procedure indicated in item 12.1. of the request for the taking of evidence (form A) could not be complied with because: 5.1. the requested procedure is incompatible with the law of the Member State of the requested court: ☐ 5.2. the carrying out of the requested procedure is not possible by reason of major practical difficulties: ☐ 6. The call for execution of the request for the taking of evidence using distance communications technology indicated in item 12.2. of the request for the taking of evidence (form A) could not be complied with because: 6.1. The use of communications technology is incompatible with the law of the Member State of the requested court ☐ 6.2. The use of the communications technology is not possible by reason of major practical difficulties ☐ Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: FORM I NOTIFICATION OF THE DATE, TIME, PLACE OF THE TAKING OF EVIDENCE AND THE CONDITIONS FOR PARTICIPATION (Articles 13(4) and 14(5) of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (15)) 1. Reference No of the requesting court: 2. Reference No of the requested court: 3. Requesting court 3.1. Name: 3.2. Address: 3.2.1. Street and number/PO box: 3.2.2. Place and postcode: 3.2.3. Country: 3.3. Tel. 3.4. Fax ((*)): 3.5. Email: 4. Requested court 4.1. Name: 4.2. Address: 4.2.1. Street and number/PO box: 4.2.2. Place and postcode: 4.2.3. Country: 4.3. Tel. 4.4. Fax ((*)): 4.5. Email: 5. Date and time of the taking of evidence: 6. Place of the taking of evidence, if different from that referred to in item 4: 7. Where appropriate, conditions under which the parties and their representatives, if any, may participate: 8. Where appropriate, conditions under which the representatives of the requesting court may participate: Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: FORM J NOTIFICATION OF DELAY (Article 17 of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (16)) 1. Reference No of the requesting court: 2. Reference No of the requested court: 3. Name of the requesting court: 4. Name of the requested court: 5. The request for the taking of evidence cannot be executed within 90 days of receipt for the following reasons: 5.1. Determination of current address of the person to be examined is in progress ☐ 5.2. Service of summons on the person to be examined is in progress ☐ 5.3. Person did not appear at the hearing despite being served the summons ☐ 5.4. Request replied to on … (date). Reply attached ☐ 5.5. Payment of a deposit or advance requested on … (date) has not been received ☐ 5.6. Other (please specify): … ☐ 6. It is estimated that the request will be executed by … (indicate an estimated date). Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: FORM K INFORMATION ON THE EXECUTION OF THE REQUEST FOR THE TAKING OF EVIDENCE (Articles 16 and 18 of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (17)) 1. Reference No of the requesting court: 2. Reference No of the requested court: 3. Name of the requesting court: 4. Name of the requested court: 5. The request for the taking of evidence has been executed ☐ The documents confirming execution of the request for the taking of evidence are attached: 6. Execution of the request for the taking of evidence has been refused because: 6.1. The person to be examined has invoked the right to refuse to give evidence or has claimed to be prohibited from giving evidence: ☐ 6.1.1. under the law of the Member State of the requested court: ☐ 6.1.2. under the law of the Member State of the requesting court: ☐ 6.2. The request for the taking of evidence does not fall within the scope of Regulation (EU) 2020/1783 ☐ 6.3. Under the law of the Member State of the requested court, the execution of the request for the taking of evidence does not fall within the functions of the judiciary ☐ 6.4. The requesting court has not complied with the request for additional information from the requested court dated … (date of the request for additional information) ☐ 6.5. A deposit or advance asked for in accordance with Article 22(3) of Regulation (EU) 2020/1783 has not been made. ☐ 7. Other reasons for non-execution: Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: FORM L REQUEST FOR DIRECT TAKING OF EVIDENCE (Articles 19 and 20 of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (18)) 1. Reference No of the requesting court: 2. Reference No of the central body/competent authority ((*)): 3. Requesting court: 3.1. Name: 3.2. Address: 3.2.1. Street and number/PO box: 3.2.2. Place and postcode: 3.2.3. Country: 3.3. Tel. 3.4. Fax ((*)): 3.5. Email: 4. Central body/competent authority of the requested State 4.1. Name: 4.2. Address: 4.2.1. Street and number/PO box: 4.2.2. Place and postcode: 4.2.3. Country: 4.3. Tel. 4.4. Fax ((*)): 4.5. Email: 5. In the case brought by the claimant/petitioner(s) (19) 5.1. Name: 5.2. Address: 5.2.1. Street and number/PO box: 5.2.2. Place and postcode: 5.2.3. Country: 5.3. Tel. ((*)): 5.4. Fax ((*)): 5.5. Email ((*)): 6. Representatives of the claimant/petitioner 6.1. Name: 6.2. Address: 6.2.1. Street and number/PO box: 6.2.2. Place and postcode: 6.2.3. Country: 6.3. Tel. 6.4. Fax ((*)): 6.5. Email: 7. Against the defendant/respondent(s) (20) 7.1. Name: 7.2. Address: 7.2.1. Street and number/PO box: 7.2.2. Place and postcode: 7.2.3. Country: 7.3. Tel. ((*)): 7.4. Fax ((*)): 7.5. Email ((*)): 8. Representatives of defendant/respondent 8.1. Name: 8.2. Address: 8.2.1. Street and number/PO box: 8.2.2. Place and postcode: 8.2.3. Country: 8.3. Tel. 8.4. Fax ((*)): 8.5. Email: 9. The evidence will be taken by: 9.1. Name: 9.2. Title: 9.3. Function: 9.4. Task: 10. Nature and subject matter of the case and a brief statement of the facts (in annex, where appropriate): 11. Taking of evidence to be carried out 11.1. Description of the taking of evidence (in annex, where appropriate): 11.2. Examination of witnesses 11.2.1. Names and surname: 11.2.2. Date of birth, if available: 11.2.3. Address: 11.2.3.1. Street and number/PO box: 11.2.3.2. Place and postcode: 11.2.3.3. Country: 11.2.4. Tel. ((*)): 11.2.5. Fax ((*)): 11.2.6. Email ((*)): 11.2.7. Questions to be put to the witness or a statement of the facts about which they are to be examined (in the annex, where appropriate): 11.2.8. Right to refuse to testify under the law of the Member State of the requesting court (in annex, where appropriate): yes ☐ no ☐ 11.3. Other taking of evidence (in annex, where appropriate): 12. The requesting court asks that evidence be taken directly by using the communications technology set out in form N ☐ Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: FORM M INFORMATION FROM THE CENTRAL BODY/COMPETENT AUTHORITY CONCERNING DIRECT TAKING OF EVIDENCE (Article 19 of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (21)) 1. Reference No of the requesting court: 2. Reference No of the central body/competent authority: 3. Name of the requesting court: 4. Central body/competent authority 4.1. Name: 4.2. Address: 4.2.1. Street and number/PO box: 4.2.2. Place and postcode: 4.2.3. Country: 4.3. Tel. 4.4. Fax ((*)): 4.5. Email: 5. Information from the central body/competent authority 5.1. Direct taking of evidence in accordance with the request is accepted: ☐ 5.2. Direct taking of evidence in accordance with the request is accepted under the following conditions (in annex, where appropriate): 5.3. Direct taking of evidence in accordance with the request is refused for the following reasons: 5.3.1. the request does not fall within the scope of Regulation (EU) 2020/1783: ☐ 5.3.2. the request does not contain all of the necessary information pursuant to Article 5 of Regulation (EU) 2020/1783: ☐ 5.3.3. the direct taking of evidence requested is contrary to fundamental principles of law of the Member State of the central body/competent authority: ☐ 6. The following court was assigned to provide practical assistance in the direct taking of evidence: 6.1. Name: 6.2. Address: 6.2.1. Street and number/PO box: 6.2.2. Place and postcode: 6.2.3. Country: 6.3. Tel. 6.4. Fax ((*)): 6.5. Email: Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: FORM N INFORMATION ON TECHNICAL PRACTICALITIES FOR HOLDING A VIDEOCONFERENCE OR USING OTHER DISTANCE COMMUNICATIONS TECHNOLOGY (Articles 12(4) and 20 of Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (22)) 1. Reference No of the requesting court ((*)): 2. Reference No of the requested court ((*)): 3. Name of the requesting court ((*)): 4. Name of the requested court ((*)): 5. Technical data of the requesting court: 5.1. ISDN ((*)): 5.2. IP: 5.3. Tel. Court room ((*)): 5.4. Other: 6. Preferred form of connection (in case of more options filled in item 5): 7. Preferred date(s) and time(s) of connection: 7.1. date: 7.2. time (23): 8. Preferred date(s) and time(s) for the test connection: 8.1. date: 8.2. time (23): 8.3. contact person for the test connection or other technical assistance: 8.4. language for communication: ☐ BG, ☐ ES, ☐ CZ, ☐ DE, ☐ ET, ☐ EL, ☐ EN, ☐ FR, ☐ GA, ☐ HR, ☐ IT, ☐ LV, ☐ LT, ☐ HU, ☐ MT, ☐ NL, ☐ PL, ☐ PT, ☐ RO, ☐ SK, ☐ SL, ☐ FI, ☐ SV, ☐ other: 8.5. tel. in the event of technical difficulties during the test connection or the taking of evidence: 9. Information on interpretation: 9.1. Assistance for finding an interpreter is requested: ☐ 9.2. The relevant languages: ☐ BG, ☐ ES, ☐ CZ, ☐ DE, ☐ ET, ☐ EL, ☐ EN, ☐ FR, ☐ GA, ☐ HR, ☐ IT, ☐ LV, ☐ LT, ☐ HU, ☐ MT, ☐ NL, ☐ PL, ☐ PT, ☐ RO, ☐ SK, ☐ SL, ☐ FI, ☐ SV, ☐ other: 10. Information on whether a recording of the taking of evidence will be made (24): 10.1. yes ☐ 10.2. no ☐ 11. Other: … Done at: Date: Signature and/or stamp or electronic signature and/or electronic seal: (1) OJ L 405, 2.12.2020, p. 1. ((*)) This item is optional. (2) Where there is more than one claimant/petitioner, please provide information as set out in items 4.1. to 4.5. (3) Where there is more than one defendant/respondent, please provide information as set out in items 6.1. to 6.5. (4) Where there is more than one representative, please provide information as set out in item 9.2. (5) This item only applies from the date of application of the decentralised IT system. (6) OJ L 405, 2.12.2020, p. 1. ((*)) This item is optional. (7) OJ L 405, 2.12.2020, p. 1 ((*)) This item is optional. (8) OJ L 405, 2.12.2020, p. 1. (9) OJ L 405, 2.12.2020, p. 1 (10) The use of this form is optional. (11) OJ L 405, 2.12.2020, p. 1 (12) The use of this form is optional. (13) OJ L 405, 2.12.2020, p. 1 (14) OJ L 405, 2.12.2020, p. 1. (15) OJ L 405, 2.12.2020, p. 1 ((*)) This item is optional. (16) OJ L 405, 2.12.2020, p. 1 (17) OJ L 405, 2.12.2020, p. 1 (18) OJ L 405, 2.12.2020, p. 1. ((*)) This item is optional. (19) Where there is more than one claimant/petitioner, please provide information as set out in items 5.1. to 5.5. (20) Where there is more than one defendant/respondent, please provide information as set out in items 7.1. to 7.5. (21) OJ L 405, 2.12.2020, p. 1 ((*)) This item is optional. (22) OJ L 405, 2.12.2020, p. 1 ((*)) This item is optional. (23) Local time of requested Member State. (24) E.g. online record or transcript of the taking of evidence ANNEX II REPEALED REGULATION WITH LIST OF THE SUCCESSIVE AMENDMENTS THERETO Council Regulation (EC) No 1206/2001 of 28 May 2001 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (OJ L 174, 27.6.2001, p. 1). Regulation (EC) No 1103/2008 of the European Parliament and of the Council of 22 October 2008 adapting a number of instruments subject to the procedure laid down in Article 251 of the Treaty to Council Decision 1999/468/EC, with regard to the regulatory procedure with scrutiny – Adaptation to the regulatory procedure with scrutiny – Part Three (OJ L 304, 14.11.2008, p. 80). Only amendments to Articles 19(2) and 20 of Regulation (EC) No 1206/2001 ANNEX III CORRELATION TABLE Regulation (EC) No 1206/2001 This Regulation Article 1(1) Article 1(1) Article 1(2) Article 1(2) Article 1(3) – – Article 2 Article 2(1) Article 3(1) Article 2(2) Article 3(2) Article 3(1) Article 4(1) Article 3(2) Article 4(2) Article 3(3) Article 4(3) Article 4(1) Article 5(1) Article 4(2) Article 5(2) Article 4(3) Article 5(3) Article 5 Article 6 Article 6 –Article 7(1) – Article 7(2), (3) and (4) – Article 8 Article 7(1) Article 9(1) Article 7(2) Article 9(2) Article 8(1) Article 10(1) Article 8(2) Article 10(2) Article 9(1) Article 11(1) Article 9(2) Article 11(2) Article 10(1) Article 12(1) Article 10(2) Article 12(2) Article 10(3) Article 12(3) Article 10(4) Article 12(4) Article 11(1) Article 13(1) Article 11(2) Article 13(2) Article 11(3) Article 13(3) Article 11(4) Article 13(4) Article 11(5) Article 13(5) Article 12(1) Article 14(1) Article 12(2) Article 14(2) Article 12(3) Article 14(3) Article 12(4) Article 14(4) Article 12(5) Article 14(5) Article 13 Article 15 Article 14(1) Article 16(1) Article 14(2) Article 16(2) Article 14(3) Article 16(3) Article 14(4) Article 16(4) Article 15 Article 17 Article 16 Article 18 Article 17(1) Article 19(1) Article 17(2) Article 19(2) Article 17(3) Article 19(3) Article 17(4), first subparagraph Article 19(4), first subparagraph Article 17(4), second subparagraph Article 19(4), second subparagraph Article 17(4), third subparagraph – – Article 19(5) – Article 19(6) Article 17(5) Article 19(7) Article 17(6) Article 19(8) – Article 20 – Article 21 Article 18 Article 22 Article 19(1) Article 23(1) Article 19(2) – – Article 23(2) Article 20 Article 26 – Article 24 – Article 25 – Article 27 – Article 28 Article 21(1) Article 29(1) Article 21(2) Article 29(2) Article 21(3)(a) – Article 21(3)(b) Article 29(3)(a) Article 21(3)(c) Article 29(3)(b) – Article 30 Article 22, first paragraph Article 31(1) Article 22, second paragraph Article 31(2) – Article 31(3) – Article 31(4) – Article 32 Article 23 Article 33(1) – Article 33(2) Article 24 – – Article 34 Article 24(1) Article 35(1), first subparagraph Article 24(2) Article 35(1), second subparagraph – Article 35(2) Article 35(3) Annex Annex I – Annex II – Annex III

Taking of evidence in civil and commercial matters Taking of evidence in civil and commercial matters SUMMARY OF: Regulation (EU) 2020/1783 on cooperation between the courts of the EU countries in taking evidence in civil or commercial matters WHAT IS THE AIM OF THE REGULATION? It aims to improve the effectiveness and speed of cross-border judicial proceedings in civil and commercial cases by simplifying and streamlining procedures for taking evidence. KEY POINTS The regulation applies in civil and commercial matters when a court* (‘requesting court’) either asks a court in another EU country (‘requested court’) to take evidence or wishes to do so directly itself. Requests to obtain evidence are: used only in judicial proceedings already underway or being considered; submitted, in an official EU language, on a standard form containing all the necessary details; transmitted through a secure and reliable decentralised IT system that respects fundamental rights and freedoms; acknowledged to have been received within 7 days by the court; processed under different deadlines if the request is incomplete or the requested court does not have the necessary jurisdiction. A court requested to take evidence: acts without delay and, at the latest, within 90 days; may use video- or tele-conferencing if asked to do so by the requesting court and its national law allows it; allows the parties and their representatives, including those of the requesting court, to attend when evidence is taken if that right exists in the country of the requesting court; may reject the request if: the person to be examined invokes the right to refuse to give evidence or is banned by law from doing so,the application does not comply with the regulation or is outside the court’s competence,the requesting court does not provide any additional information required or a deposit within the necessary deadlines. A court looking to take evidence itself directly in another EU country: contacts the country’s central body or competent authority which within 30 days accepts or rejects the request and may attach conditions and assign a particular court; may use video-conferencing or another form of distance communication to question the person concerned. In general, a court asked to take evidence may not claim reimbursement from the requesting court for taxes or costs, but may do so to cover: fees for experts and interpreters, including a deposit or an advance towards the likely costs of the former; the expense of video- or tele-conferencing. EU countries: designate a central body to: supply information to courts,sort out any difficulties that may arise,forward, in exceptional cases, requests to the competent court; provide the European Commission with practical information, such as the details of the central bodies and competent authorities; cover the costs of installing, operating and maintaining the national IT systems used. The Commission: draws up and updates an electronic manual of practical information it receives from national authorities; may adopt delegated and implementing acts on technical aspects of the legislation; is responsible for creating, maintaining, developing and financing software that national authorities may use instead of their national IT system; establishes, by 2 July 2023, a detailed programme to monitor the output, results and impact of the regulation; submits an evaluation report to the European Parliament, the Council and the European Economic and Social Committee. The regulation does not apply in Denmark. Repeal Regulation (EU) 2020/1783 repeals and replaces Regulation (EC) No 1206/2001 (see summary). FROM WHEN DOES THE REGULATION APPLY? It applies from 1 July 2022. Regulation (EU) 2020/1783 revises and replaces Regulation (EC) No 1206/2001 (and its subsequent amendments), notably through the use of digitalisation and modern technology to speed up processes and reduce costs and delays for individuals and businesses. BACKGROUND Judicial civil procedures cover matters such as contracts, property, succession and family and company law. By 2018, some 3.4 million civil and commercial court cases involved more than one EU country. For more information, see: What is civil justice cooperation? (European Commission). KEY TERMS Court: any national authority that may take evidence (i.e. not only judicial bodies). MAIN DOCUMENT Regulation (EU) 2020/1783 of the European Parliament and of the Council of 25 November 2020 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (taking of evidence) (recast) (OJ L 405, 2.12.2020, pp. 1-39) RELATED DOCUMENTS Council Regulation (EC) No 1206/2001 of 28 May 2001 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters (OJ L 174, 27.6.2001, pp. 1-24) Successive amendments to Regulation (EC) No 1206/2001 have been incorporated into the original text. This consolidated version is of documentary value only. last update 26.01.2021

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14.6.2019 EN Official Journal of the European Union L 158/1 REGULATION (EU) 2019/941 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 June 2019 on risk-preparedness in the electricity sector and repealing Directive 2005/89/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 194(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The electricity sector in the Union is undergoing a profound transformation, characterised by more decentralised markets with more players, a higher proportion of energy from renewable sources and better interconnected systems. In response, Regulation (EU) 2019/943 of the European Parliament and of the Council (4) and Directive (EU) 2019/944 of the European Parliament and of the Council (5) aim to upgrade the legal framework governing the Union's internal electricity market, in order to ensure that markets and networks function in an optimal manner, to the benefit of businesses and Union citizens. This Regulation is intended to contribute to the implementation of the objectives of the Energy Union, of which energy security, solidarity, trust and an ambitious climate policy are an integral part. (2) Well-functioning markets and systems, with adequate electricity interconnections, are the best guarantee of security of electricity supply. However, even where markets and systems function well and are interconnected, the risk of an electricity crisis, as a result of natural disasters, such as extreme weather conditions, malicious attacks or fuel shortages, can never be excluded. The consequences of electricity crises often extend beyond national borders. Even where such crises start locally, their effects can rapidly spread across borders. Some extreme circumstances, such as cold spells, heat waves or cyberattacks, may affect entire regions at the same time. (3) In a context of interlinked electricity markets and systems, electricity crisis prevention and management cannot be considered to be a purely national task. The potential of more efficient and less costly measures through regional cooperation should be better exploited. A common framework of rules and better coordinated procedures are needed in order to ensure that Member States and other actors are able to cooperate effectively across borders, in a spirit of increased transparency, trust and solidarity between Member States. (4) Directive 2005/89/EC of the European Parliament and of the Council (6) established the necessary measures that the Member States are to take in order to ensure security of electricity supply in general. The provisions of that Directive have largely been superseded by subsequent legislative acts, in particular as regards how electricity markets are to be organised in order to ensure the availability of sufficient capacity, how transmission system operators are to cooperate to guarantee system stability, and as regards ensuring that appropriate infrastructure is in place. This Regulation addresses the specific issue of electricity crisis prevention and management. (5) Commission Regulations (EU) 2017/1485 (7) and (EU) 2017/2196 (8) constitute a detailed rulebook governing how transmission system operators and other relevant stakeholders should act and cooperate to ensure system security. Those technical rules should ensure that most electricity incidents are dealt with effectively at operational level. This Regulation focuses on electricity crises that have a larger scale and impact. It sets out what Member States should do to prevent such crises and what measures they can take should system operation rules alone no longer suffice. Even in electricity crises system operation rules should continue to be fully respected and this Regulation should be consistent with Regulation (EU) 2017/2196. (6) This Regulation sets out a common framework of rules on how to prevent, prepare for and manage electricity crises, bringing more transparency in the preparation phase and during an electricity crisis and ensuring that measures are taken in a coordinated and effective manner. It requires Member States to cooperate, at regional level and, where applicable, bilaterally, in a spirit of solidarity. It also sets out a framework for the effective monitoring of security of electricity supply in the Union via the Electricity Coordination Group (ECG), which was set up by a Commission Decision of 15 November 2012 (9) as a forum in which to exchange information and foster cooperation among Member States, in particular in the area of security of electricity supply. Member State cooperation and the monitoring framework are intended to achieve better risk-preparedness at a lower cost. This Regulation should also strengthen the internal electricity market by enhancing trust and confidence across Member States and ruling out inappropriate state interventions in electricity crises, in particular avoiding undue curtailment of cross-border flows and cross zonal transmission capacities, thus reducing the risk of negative spillover effects on neighbouring Member States. (7) Directive (EU) 2016/1148 of the European Parliament and of the Council (10) lays down general rules on security of network and information systems, while specific rules on cybersecurity will be developed through a network code as laid down in Regulation (EU) 2019/943. This Regulation complements Directive (EU) 2016/1148 by ensuring that cyber-incidents are properly identified as a risk, and that the measures taken to address them are properly reflected in the risk-preparedness plans. (8) Council Directive 2008/114/EC (11) lays down a process with a view to enhancing the security of designated European critical infrastructure, including certain electricity infrastructure. Directive 2008/114/EC, together with this Regulation, contributes to creating a comprehensive approach to the energy security of the Union. (9) Decision No 1313/2013/EU of the European Parliament and of the Council (12) sets out requirements for Member States to develop risk assessments at national level or at the appropriate sub-national level every three years, and to develop and refine their disaster risk management planning at national level or at the appropriate sub-national level. The specific risk prevention, preparedness and planning actions set out in this Regulation should be consistent with the wider, multi-hazard national risk assessments required under Decision No 1313/2013/EU. (10) Member States are responsible for ensuring the security of electricity supply within their territories, while security of electricity supply is also a responsibility shared among the Commission and other Union actors, within their respective areas of activity and competence. Security of electricity supply entails effective cooperation among Member States, Union institutions, bodies, offices and agencies, and relevant stakeholders. Distribution system operators and transmission system operators play a key role in ensuring a secure, reliable and efficient electricity system in accordance with Articles 31 and 40 of Directive (EU) 2019/944. The regulatory authorities and other relevant national authorities also play an important role in ensuring and monitoring the security of electricity supply, as part of their tasks attributed by Article 59 of Directive (EU) 2019/944. Member States should designate an existing or new entity as their single competent national governmental or regulatory authority with the aim of ensuring the transparent and inclusive participation of all actors involved, the efficient preparation and proper implementation of the risk-preparedness plans, as well as facilitating the prevention and ex post evaluation of electricity crises and information exchanges in relation thereto. (11) A common approach to electricity crisis prevention and management requires a common understanding among Member States as to what constitutes an electricity crisis. In particular this Regulation should facilitate coordination among Member States for the purpose of identifying a situation in which the potential risk of a significant electricity shortage or an impossibility to supply electricity to customers is present or imminent. The European Network of Transmission System Operators for Electricity (‘ENTSO for Electricity’) and the Member States should, respectively, determine concrete regional and national electricity crisis scenarios. That approach should ensure that all relevant electricity crises are covered, taking into account regional and national specificities such as the topology of the grid, the electricity mix, the size of production and consumption, and the degree of population density. (12) A common approach to electricity crisis prevention and management also requires that Member States use the same methods and definitions to identify risks relating to the security of electricity supply and are in a position to compare effectively how well they and their neighbours perform in that area. This Regulation identifies two indicators for monitoring the security of electricity supply in the Union: ‘expected energy non-served’, expressed in GWh/year, and ‘loss of load expectation’, expressed in hours per year. Those indicators are part of the European resource adequacy assessment carried out by the ENTSO for Electricity, pursuant to Article 23 of Regulation (EU) 2019/943. The ECG should carry out regular monitoring of the security of electricity supply based on the results of those indicators. The Agency for the Cooperation of Energy Regulators (ACER) should also use those indicators when reporting on Member States' performance in the area of security of electricity supply in its annual electricity market monitoring reports, pursuant to Article 15 of Regulation (EU) 2019/942 of the European Parliament and of the Council (13). (13) To ensure the coherence of risk assessments in a manner that builds trust between Member States in an electricity crisis, a common approach to identifying risk scenarios is needed. The ENTSO for Electricity should therefore, after consulting the relevant stakeholders, develop and update a common methodology for risk identification in cooperation with ACER, and with the ECG in its formation composed only of representatives of the Member States. The ENTSO for Electricity should propose the methodology and ACER should approve it. When consulting the ECG, ACER is to take the utmost account of the views expressed by the ECG. The ENTSO for Electricity should update the common methodology for risk identification where significant new information becomes available. (14) On the basis of the common methodology for risk identification, the ENTSO for Electricity should regularly draw up and update regional electricity crisis scenarios and identify the most relevant risks for each region such as extreme weather conditions, natural disasters, fuel shortages or malicious attacks. When considering the crisis scenario of a gas fuel shortage, the risk of disruption of the gas supply should be assessed based on the gas supply and infrastructure disruption scenarios developed by the European Network of Transmission System Operators for Gas (ENTSOG) pursuant to Article 7 of Regulation (EU) 2017/1938 of the European Parliament and of the Council (14). The ENTSO for Electricity should be able to delegate tasks relating to the identification of regional electricity crisis scenarios to regional coordination centres established pursuant to Article 35 of Regulation (EU) 2019/943. Those delegated tasks should be performed under the supervision of the ENTSO for Electricity. Member States should establish and update their national electricity crisis scenarios on the basis of regional electricity crisis scenarios, in principle every four years. Those scenarios should provide the basis for the risk-preparedness plans. When identifying risks at national level, the Member States should describe any risks that they identify in relation to the ownership of the infrastructure relevant for security of electricity supply and any measures taken to address those risks such as general or sector-specific investment screening laws, special rights for certain shareholders, with an indication why they consider such measures to be necessary and proportionate. (15) A regional approach to identifying risk scenarios and to developing preventive, preparatory and mitigating measures should bring significant benefits in terms of the effectiveness of those measures and the optimal use of resources. Moreover, in a simultaneous electricity crisis, a coordinated and pre-agreed approach would ensure a consistent response and reduce the risk of negative spillover effects that purely national measures could have in neighbouring Member States. This Regulation therefore requires Member States to cooperate in a regional context. (16) The regional coordination centres should perform the tasks of regional relevance assigned to them in accordance with Regulation (EU) 2019/943. To ensure that they can carry out their tasks effectively and act in close cooperation with relevant national authorities with a view to preventing and mitigating larger-scale electricity incidents, the regional cooperation required under this Regulation should build on the regional cooperation structures used at technical level, namely the groups of Member States sharing the same regional coordination centre. The geographical regions of the regional coordination centres are therefore relevant for the identification of the regional electricity crisis scenarios and risk assessments. However, Member States should have the possibility to form subgroups within the regions for the purpose of cooperation with regard to concrete regional measures, or to cooperate in existing regional cooperation forums for that purpose, as the technical ability to provide mutual assistance to each other in an electricity crisis is essential. This is because not all Member States in a larger region will necessarily be able to provide electricity to another Member State in an electricity crisis. Thus, it is not necessary for all Member States in a region to conclude regional agreements on concrete regional measures. Instead, Member States that have the technical ability to provide assistance to each other should conclude such agreements. (17) Regulation (EU) 2019/943 provides for the use of a common methodology for the medium to long-term European resource adequacy assessment (from 10-year-ahead to year-ahead), with a view to ensuring that Member States' decisions as to possible investment needs are made on a transparent and commonly agreed basis. The European resource adequacy assessment has a different purpose from the short-term adequacy assessments which are used to detect possible adequacy related problems in short time-frames, namely seasonal adequacy assessments (six months ahead) and week-ahead to at least day-ahead adequacy assessments. Regarding short-term assessments, there is a need for a common approach to the way possible adequacy-related problems are detected. The ENTSO for Electricity should carry out winter and summer adequacy assessments to alert Member States and transmission system operators to risks related to the security of electricity supply that might occur in the following six months. To improve those adequacy assessments, the ENTSO for Electricity should develop a common probabilistic methodology for them, after consulting the relevant stakeholders, and in cooperation with ACER, and with the ECG, in its formation composed only of representatives of the Member States. The ENTSO for Electricity should propose that methodology and updates thereto to ACER, and ACER should approve the proposal and the updates. When consulting the ECG, ACER is to take the utmost account of the views expressed by the ECG. The ENTSO for Electricity should update the methodology where significant new information becomes available. The ENTSO for Electricity should be able to delegate tasks relating to seasonal adequacy assessments to regional coordination centres, while delegated tasks should be performed under the ENTSO for Electricity's supervision. (18) Transmission system operators should apply the methodology used to prepare seasonal adequacy assessments when carrying out any other type of short-term risk assessment, namely the week-ahead to at least day-ahead generation adequacy forecasts provided for in Regulation (EU) 2017/1485. (19) To ensure a common approach to electricity crisis prevention and management, the competent authority of each Member State should draw up a risk-preparedness plan on the basis of the regional and national electricity crisis scenarios. The competent authorities should consult stakeholders or representatives of stakeholder groups, such as representatives of producers or their trade bodies or of distribution system operators, where they are relevant for the prevention and handling of an electricity crisis. To that end, the competent authorities should decide on the appropriate arrangements for carrying out the consultation. The risk-preparedness plans should describe effective, proportionate and non-discriminatory measures addressing all identified electricity crisis scenarios. The environmental impact of demand-side and supply-side measures proposed should be taken into account. The plans should provide transparency especially as regards the conditions in which non-market-based measures can be taken to mitigate electricity crises. All envisaged non-market-based measures should comply with the rules laid down in this Regulation. The risk-preparedness plans should be made public, while ensuring confidentiality of sensitive information. (20) The risk-preparedness plans should set out national, regional and, where applicable, bilateral measures. Regional and, where applicable, bilateral measures are necessary, in particular in the event of a simultaneous electricity crisis, when a coordinated and pre-agreed approach is needed to ensure a consistent response and reduce the risk of negative spillover effects. To that end, before adopting the risk-preparedness plans, competent authorities should consult the competent authorities of the relevant Member States. The relevant Member States are those where there could be negative spillover effects or other impacts on each other's electricity system, whether those Member States are in the same region or directly connected. The plans should take account of the relevant national circumstances, including the situation of outermost regions within the meaning of Article 349 of the Treaty on the Functioning of the European Union, and of some micro-isolated systems that are not connected to the national transmission systems. In that respect, Member States should draw the appropriate conclusions as regards, inter alia, the provisions of this Regulation on identification of regional electricity crisis scenarios and the regional and bilateral measures set out in risk-preparedness plans as well as provisions on assistance. The plans should clearly set out the roles and responsibilities of the competent authorities. National measures should take full account of the regional and bilateral measures that have been agreed and should take full advantage of the opportunities provided by regional cooperation. The plans should be technical and operational in nature, their function being to help prevent the occurrence or escalation of an electricity crisis and to mitigate its effects. (21) The risk-preparedness plans should be updated regularly. To ensure that the plans are up-to-date and effective, the competent authorities of the Member States of each region should organise biennial simulations of electricity crises in cooperation with transmission system operators and other relevant stakeholders in order to test their suitability. (22) The template provided for in this Regulation is intended to facilitate the preparation of the plans, allowing for the inclusion of additional, Member State specific information. The template is also intended to facilitate consultation of other Member States in the region concerned and the ECG. Consultation within the region and within the ECG should ensure that measures taken in one Member State or region do not put at risk the security of electricity supply of other Member States or regions. (23) It is important to facilitate communication and transparency between Member States, where they have concrete, serious and reliable information that an electricity crisis may occur. In such circumstances the Member States concerned should inform the Commission, the neighbouring Member States and the ECG without undue delay, providing, in particular, information on the causes of the deterioration of the electricity supply situation, the planned measures to prevent the electricity crisis and the possible need for assistance from other Member States. (24) Information exchange in the event of an electricity crisis is essential in order to ensure coordinated action and targeted assistance. Therefore, this Regulation obliges the competent authority to inform the Member States in the region, the neighbouring Member States and the Commission without undue delay when confronted with an electricity crisis. The competent authority should also provide information on the causes of the crisis, the measures planned or taken to mitigate the crisis and the possible need for assistance from other Member States. Where that assistance goes beyond security of electricity supply, the Union Civil Protection Mechanism should remain the applicable legal framework. (25) In the event of an electricity crisis Member States should cooperate in a spirit of solidarity. In addition to that general rule, appropriate provision should be made for Member States to offer each other assistance in an electricity crisis. Such assistance should be based on agreed, coordinated measures set out in the risk-preparedness plans. This Regulation gives Member States a wide discretion when agreeing on the content of such coordinated measures and thus on the content of the assistance that they offer. It is for Member States to decide and agree on such coordinated measures, taking into account demand and supply. At the same time, this Regulation ensures that, for the purpose of the agreed assistance, electricity is delivered in a coordinated manner. Member States should agree on the necessary technical, legal and financial arrangements for the implementation of the regional and bilateral measures that have been agreed. Under those technical arrangements the Member States should indicate the maximum quantities of electricity to be delivered, which should be re-assessed on the basis of the technical feasibility of delivering electricity once the assistance is required during an electricity crisis. Subsequently, Member States should take all necessary measures for the implementation of the regional and bilateral measures that have been agreed and technical, legal and financial arrangements. (26) When agreeing on coordinated measures and technical, legal and financial arrangements and otherwise implementing provisions on assistance, Member States should take account of social and economic factors, including the security of Union citizens, and proportionality. They are encouraged to exchange best practices and to use the ECG as a discussion platform through which to identify the available options for assistance, in particular concerning coordinated measures and the necessary technical, legal and financial arrangements, including fair compensation. The Commission may facilitate the preparation of the regional and bilateral measures. (27) Assistance between Member States under this Regulation should be subject to fair compensation agreed between the Member States. This Regulation does not harmonise all aspects of such fair compensation between Member States. The Member States should therefore agree on provisions on fair compensation before assistance is provided. The Member State requesting assistance should promptly pay, or ensure the prompt payment of, such compensation to the Member State providing the assistance. The Commission should provide for non-binding guidance on the key elements of fair compensation and other elements of the technical, legal and financial arrangements. (28) In providing assistance under this Regulation, Member States implement Union law and are therefore bound to respect fundamental rights guaranteed by Union law. Such assistance may therefore, depending on the measures agreed between Member States, give rise to an obligation on a Member State to pay compensation to those affected by its measures. Member States should therefore, where necessary, ensure that national compensation rules which comply with Union law, in particular with fundamental rights, are in place. Moreover, the Member State that receives assistance should ultimately bear all the reasonable costs that another Member State incurs as a result of providing assistance pursuant to such national compensation rules. (29) In the event of an electricity crisis, assistance should be provided even if Member States have not yet agreed on coordinated measures and technical, legal and financial arrangements as required by the provisions of this Regulation on assistance. In order to be able to provide assistance in such a situation in accordance with this Regulation, Member States should agree on ad hoc measures and arrangements in place of the absent coordinated measures and technical, legal and financial arrangements. (30) This Regulation introduces such an assistance mechanism between Member States as an instrument to prevent or mitigate an electricity crisis within the Union. The Commission should therefore review the assistance mechanism in light of future experience with its functioning, and propose, where appropriate, modifications thereto. (31) This Regulation should enable electricity undertakings and customers to rely on the market mechanisms laid down in Regulation (EU) 2019/943 and Directive (EU) 2019/944 for as long as possible when coping with electricity crises. Rules governing the internal market and system operation rules should be complied with even in electricity crises. Such rules include point (i) of Article 22(1) of Regulation (EU) 2017/1485 and Article 35 of Regulation (EU) 2017/2196, which govern transaction curtailment, limitation of provision of cross zonal capacity for capacity allocation or limitation of provision of schedules. This means that non-market-based measures, such as forced demand disconnection, or the provision of extra supplies outside normal market functioning should be taken only as a last resort, when all possibilities provided by the market have been exhausted. Therefore, forced demand disconnection should be introduced only after all possibilities for voluntary demand disconnection have been exhausted. In addition, any non-market-based measures should be necessary, proportionate, non-discriminatory and temporary. (32) In order to ensure transparency after an electricity crisis, the competent authority that declared the electricity crisis should carry out an ex post evaluation of the crisis and its impact. That evaluation should take into account, inter alia, the effectiveness and proportionality of the measures taken as well as their economic cost. That evaluation should also cover cross-border considerations, such as the impact of the measures on other Member States and the level of the assistance that the Member State that declared the electricity crisis received from them. (33) The transparency obligations should ensure that all measures that are taken to prevent or manage electricity crises comply with internal market rules and are in line with the principles of cooperation and solidarity which underpin the Energy Union. (34) This Regulation reinforces the role of the ECG. It should carry out specific tasks, in particular in connection with the development of a methodology for identifying regional electricity crisis scenarios and a methodology for short-term and seasonal adequacy assessments and in connection with the preparation of the risk-preparedness plans, and should have a prominent role in monitoring Member States' performance in the area of the security of electricity supply, and developing best practices on that basis. (35) It is possible that an electricity crisis extends beyond Union borders to the territory of the Energy Community Contracting Parties. As a party to the Treaty establishing the Energy Community, the Union should promote amendments to that Treaty with the aim of creating an integrated market and a single regulatory space by providing an appropriate and stable regulatory framework. In order to ensure efficient crisis management, the Union should closely cooperate with the Energy Community Contracting Parties when preventing, preparing for and managing an electricity crisis. (36) Where the Commission, ACER, the ECG, the ENTSO for Electricity, Member States and their competent and regulatory authorities, or any other bodies, entities or persons, receive confidential information pursuant to this Regulation, they should ensure the confidentiality of that information. To that end, confidential information should be subject to Union and national rules in place on the handling of confidential information and processes. (37) Since the objective of this Regulation, namely to ensure the most effective and efficient risk-preparedness within the Union, cannot be sufficiently achieved by Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective. (38) Cyprus is currently the only Member State which is not directly connected to another Member State. It should be clarified with respect to certain provisions of this Regulation that, for as long as this situation persists, those provisions, namely provisions on the identification of regional electricity crisis scenarios, on including regional and bilateral measures set out in risk-preparedness plans, and on assistance, do not apply with respect to Cyprus. Cyprus and relevant other Member States are encouraged to develop, with the support of the Commission, alternative measures and procedures in the fields covered by those provisions, provided that such alternative measures and procedures do not affect the effective application of this Regulation between the other Member States. (39) Directive 2005/89/EC should be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I General Provisions Article 1 Subject matter This Regulation lays down rules for cooperation between Member States with a view to preventing, preparing for and managing electricity crises in a spirit of solidarity and transparency and in full regard for the requirements of a competitive internal market for electricity. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘security of electricity supply’ means the ability of an electricity system to guarantee the supply of electricity to customers with a clearly established level of performance, as determined by the Member States concerned; (2) ‘transmission system operator’ means transmission system operator as defined in point (35) of Article 2 of Directive (EU) 2019/944; (3) ‘distribution’ means distribution as defined in point (28) of Article 2 of Directive (EU) 2019/944; (4) ‘cross-border flow’ means cross-border flow as defined in point (3) of Article 2 of Regulation (EU) 2019/943; (5) ‘cross zonal capacity’ means the capability of the interconnected system to accommodate energy transfer between bidding zones; (6) ‘customer’ means customer as defined in point (1) of Article 2 of Directive (EU) 2019/944; (7) ‘distribution system operator’ means distribution system operator as defined in point (29) of Article 2 of Directive (EU) 2019/944; (8) ‘generation’ means generation as defined in point (37) of Article 2 of Directive (EU) 2019/944; (9) ‘electricity crisis’ means a present or imminent situation in which there is a significant electricity shortage, as determined by the Member States and described in their risk-preparedness plans, or in which it is impossible to supply electricity to customers; (10) ‘simultaneous electricity crisis’ means an electricity crisis affecting more than one Member State at the same time; (11) ‘competent authority’ means a national governmental authority or a regulatory authority designated by a Member State in accordance with Article 3; (12) ‘regulatory authorities’ means regulatory authorities referred to in Article 57(1) of Directive (EU) 2019/944; (13) ‘crisis coordinator’ means a person, a group of persons, a team composed of the relevant national electricity crisis managers or an institution tasked with acting as a contact point and coordinating the information flow during an electricity crisis; (14) ‘non-market-based measure’ means any supply- or demand-side measure that deviates from market rules or commercial agreements, the purpose of which is to mitigate an electricity crisis; (15) ‘producer’ means producer as defined in point (38) of Article 2 of Directive (EU) 2019/944; (16) ‘region’ means a group of Member States whose transmission system operators share the same regional coordination centre as referred to in Article 36 of Regulation (EU) 2019/943; (17) ‘subgroup’ means a group of Member States, within a region, which have the technical ability to provide each other assistance in accordance with Article 15; (18) ‘early warning’ means a provision of concrete, serious, reliable information indicating that an event may occur which is likely to result in a significant deterioration of the electricity supply situation and is likely to lead to electricity crisis; (19) ‘transmission’ means transmission as defined in point (34) of Article 2 of Directive (EU) 2019/944; (20) ‘electricity undertaking’ means electricity undertaking as defined in point (57) of Article 2 of Directive (EU) 2019/944; (21) ‘capacity allocation’ means the attribution of cross zonal capacity; (22) ‘energy from renewable sources’ means energy from renewable sources or renewable energy as defined in point (31) of Article 2 of Directive (EU) 2019/944. Article 3 Competent authority 1. As soon as possible and in any event by 5 January 2020, each Member State shall designate a national governmental or regulatory authority as its competent authority. The competent authorities shall be responsible for, and shall cooperate with each other for the purposes of, carrying out the tasks provided for in this Regulation. Where appropriate, until the competent authority has been designated, the national entities responsible for the security of electricity supply shall carry out the tasks of the competent authority in accordance with this Regulation. 2. Member States shall, without delay, notify the Commission and the ECG and make public the name and the contact details of their competent authorities designated pursuant to paragraph 1 and any changes to their name or contact details. 3. Member States may allow the competent authority to delegate the operational tasks regarding risk-preparedness planning and risk management set out in this Regulation to other bodies. Delegated tasks shall be performed under the supervision of the competent authority and shall be specified in the risk-preparedness plan in accordance with point (b) of Article 11(1). CHAPTER II Risk assessment Article 4 Assessment of risks to security of electricity supply Each competent authority shall ensure that all relevant risks relating to security of electricity supply are assessed in accordance with the rules laid down in this Regulation and in Chapter IV of Regulation (EU) 2019/943. To that end, it shall cooperate with transmission system operators, distribution system operators, regulatory authorities, the ENTSO for Electricity, regional coordination centres and other relevant stakeholders, as required. Article 5 Methodology for identifying regional electricity crisis scenarios 1. By 5 January 2020, the ENTSO for Electricity shall submit to ACER a proposal for a methodology for identifying the most relevant regional electricity crisis scenarios. 2. The proposed methodology shall identify electricity crisis scenarios in relation to system adequacy, system security and fuel security on the basis of at least the following risks: (a) rare and extreme natural hazards; (b) accidental hazards going beyond the N-1 security criterion and exceptional contingencies; (c) consequential hazards including the consequences of malicious attacks and of fuel shortages. 3. The proposed methodology shall include at least the following elements: (a) a consideration of all relevant national and regional circumstances, including any subgroups; (b) interaction and correlation of risks across borders; (c) simulations of simultaneous electricity crisis scenarios; (d) ranking of risks according to their impact and probability; (e) principles on how to handle sensitive information in a manner that ensures transparency towards the public. 4. When considering the risks of disruption of gas supply in the context of identifying the risks pursuant to point (c) of paragraph 2 of this Article, the ENTSO for Electricity shall use the natural gas supply and infrastructure disruption scenarios developed by ENTSOG pursuant to Article 7 of Regulation (EU) 2017/1938. 5. Before submitting the proposed methodology to ACER, the ENTSO for Electricity shall conduct a consultation involving at least the regional coordination centres, industry and consumer organisations, producers or their trade bodies, transmission system operators and relevant distribution system operators, competent authorities, regulatory authorities and other relevant national authorities. The ENTSO for Electricity shall duly take into account the results of the consultation and present them, together with the proposed methodology, at a meeting of the ECG. 6. Within two months of receipt of the proposed methodology, ACER shall, after consulting the ECG, in its formation composed only of representatives of the Member States, approve or amend the proposal. The ENTSO for Electricity and ACER shall publish the final version of the methodology on their websites. 7. The ENTSO for Electricity shall update and improve the methodology in accordance with paragraphs 1 to 6 where significant new information becomes available. The ECG in its formation composed only of representatives of the Member States may recommend, and ACER or the Commission may request, such updates and improvements with due justification. Within six months of receipt of the request, the ENTSO for Electricity shall submit to ACER a draft of the proposed changes. Within two months of receipt of such a draft, ACER shall, after consulting the ECG, in its formation composed only of representatives of the Member States, approve or amend the proposed changes. The ENTSO for Electricity and ACER shall publish the final version of the updated methodology on their websites. Article 6 Identification of regional electricity crisis scenarios 1. Within six months of the approval of a methodology pursuant to Article 5(6), the ENTSO for Electricity shall, on the basis of that methodology and in close cooperation with the ECG, regional coordination centres, competent authorities and regulatory authorities, identify the most relevant electricity crisis scenarios for each region. It may delegate tasks relating to the identification of regional electricity crisis scenarios to the regional coordination centres. 2. The ENTSO for Electricity shall submit the regional electricity crisis scenarios to the relevant transmission system operators, regional coordination centres, competent authorities and regulatory authorities as well as to the ECG. The ECG may recommend amendments. 3. The ENTSO for Electricity shall update the regional electricity crisis scenarios every four years, unless circumstances warrant more frequent updates. Article 7 Identification of national electricity crisis scenarios 1. Within four months of the identification of the regional electricity crisis scenarios in accordance with Article 6(1), the competent authority shall identify the most relevant national electricity crisis scenarios. 2. In identifying the national electricity crisis scenarios, the competent authority shall consult the transmission system operators, the distribution system operators that the competent authority considers to be relevant, the relevant producers or their trade bodies, and the regulatory authority where it is not the competent authority. 3. The national electricity crisis scenarios shall be identified on the basis of at least the risks referred to in Article 5(2) and shall be consistent with the regional electricity crisis scenarios identified in accordance with Article 6(1). Member States shall update the national electricity crisis scenarios every four years, unless circumstances warrant more frequent updates. 4. Within four months of identification of regional electricity crisis scenarios in accordance with Article 6(1), Member States shall inform the ECG and the Commission of their assessment of the risks in relation to the ownership of infrastructure relevant for security of electricity supply, and any measures taken to prevent or mitigate such risks, with an indication of why such measures are considered necessary and proportionate. Article 8 Methodology for short-term and seasonal adequacy assessments 1. By 5 January 2020, the ENTSO for Electricity shall submit to ACER a proposal for a methodology for assessing seasonal and short-term adequacy, namely monthly, week-ahead to at least day-ahead adequacy, which shall cover at least the following: (a) the uncertainty of inputs such as the probability of a transmission capacity outage, the probability of an unplanned outage of power plants, severe weather conditions, variable demand, in particular peaks depending on weather conditions, and variability of production of energy from renewable sources; (b) the probability of the occurrence of an electricity crisis; (c) the probability of the occurrence of a simultaneous electricity crisis. 2. The methodology referred to in paragraph 1 shall provide for a probabilistic approach, including multiple scenarios, and shall take into account the national, regional and Union context, including the level of interconnection between Member States and, to the extent possible, third countries within synchronous areas of the Union. The methodology shall take into account the specificities of each Member State's energy sector, including specific weather conditions and external circumstances. 3. Before submitting the proposed methodology, the ENTSO for Electricity shall conduct a consultation involving at least the regional coordination centres, industry and consumer organisations, producers or their trade bodies, transmission system operators, relevant distribution system operators, competent authorities, regulatory authorities and other relevant national authorities. The ENTSO for Electricity shall duly take into account the results of the consultation and present them, together with the proposed methodology, at a meeting of the ECG. 4. Within two months of receipt of the proposed methodology, ACER shall, after consulting the ECG in its formation composed only of representatives of the Member States, approve or amend the proposal. The ENTSO for Electricity and ACER shall publish the final version of the methodology on their websites. 5. The ENTSO for Electricity shall update and improve the methodology in accordance with paragraphs 1 to 4 where significant new information becomes available. The ECG in its formation composed only of representatives of the Member States may recommend, and ACER or the Commission may request, such updates and improvements with due justification. Within six months of receipt of the request, the ENTSO for Electricity shall submit to ACER a draft of the proposed changes. Within two months of receipt of such a draft, ACER shall, after consulting the ECG, in its formation composed only of representatives of the Member States, approve or amend the proposed changes. The ENTSO for Electricity and ACER shall publish the final version of the updated methodology on their websites. Article 9 Short-term and seasonal adequacy assessments 1. All short-term adequacy assessments, whether carried out at national, regional or Union level, shall be carried out in accordance with the methodology developed pursuant to Article 8. 2. The ENTSO for Electricity shall carry out seasonal adequacy assessments in accordance with the methodology developed pursuant to Article 8. It shall publish the results for the winter adequacy assessment by 1 December each year and for the summer adequacy assessment by 1 June each year. It may delegate tasks relating to the adequacy assessments to regional coordination centres. It shall present the adequacy assessment at a meeting of the ECG, which may make recommendations where appropriate. 3. The regional coordination centres shall carry out week-ahead to at least day ahead adequacy assessments in accordance with Regulation (EU) 2017/1485 on the basis of the methodology adopted pursuant to Article 8 of this Regulation. CHAPTER III Risk-preparedness plans Article 10 Establishment of risk-preparedness plans 1. On the basis of the regional and national electricity crisis scenarios identified pursuant to Articles 6 and 7, the competent authority of each Member State shall establish a risk-preparedness plan, after consulting distribution system operators considered relevant by the competent authority, the transmission system operators, the relevant producers or their trade bodies, the electricity and natural gas undertakings, the relevant organisations that represent the interests of industrial and non-industrial electricity customers, and the regulatory authority where it is not the competent authority. 2. The risk-preparedness plan shall consist of national measures, regional and, where applicable, bilateral measures as provided for in Articles 11 and 12. In accordance with Article 16, all measures that are planned or taken to prevent, prepare for and mitigate electricity crises shall fully comply with the rules governing the internal electricity market and system operation. Those measures shall be clearly defined, transparent, proportionate and non-discriminatory. 3. The risk-preparedness plan shall be developed in accordance with Articles 11 and 12 and with the template set out in the Annex. If necessary, Member States may include additional information in the risk-preparedness plan. 4. In order to ensure consistency of risk-preparedness plans, competent authorities shall, before adopting their risk-preparedness plans, submit the draft plans, for consultation, to the competent authorities of the relevant Member States in the region and, where they are not in the same region, to the competent authorities of directly connected Member States, as well as to the ECG. 5. Within six months of receipt of the draft risk-preparedness plans, the competent authorities referred to in paragraph 4 and the ECG may issue recommendations relating to the draft plans submitted pursuant to paragraph 4. 6. Within nine months of submitting their draft plans, the competent authorities concerned shall adopt their risk-preparedness plans, taking into account the results of the consultation pursuant to paragraph 4 and any recommendations issued pursuant to paragraph 5. They shall notify their risk-preparedness plans to the Commission without delay. 7. The competent authorities and the Commission shall publish the risk-preparedness plans on their websites, while ensuring confidentiality of sensitive information, in particular information on measures relating to the prevention or mitigation of consequences of malicious attacks. The protection of the confidentiality of sensitive information shall be based on the principles determined pursuant to Article 19. 8. The competent authorities shall adopt and publish their first risk-preparedness plans by 5 January 2022. They shall update them every four years thereafter, unless circumstances warrant more frequent updates. Article 11 Content of risk-preparedness plans as regards national measures 1. The risk-preparedness plan of each Member State shall set out all national measures that are planned or taken to prevent, prepare for and mitigate electricity crises as identified pursuant to Articles 6 and 7. It shall at least: (a) contain a summary of the electricity crisis scenarios defined for the relevant Member State and region, in accordance with the procedures laid down in Articles 6 and 7; (b) establish the role and responsibilities of the competent authority and describe which tasks, if any, have been delegated to other bodies; (c) describe the national measures designed to prevent or prepare for the risks identified pursuant to Articles 6 and 7; (d) designate a national crisis coordinator and establish its tasks; (e) establish detailed procedures to be followed in electricity crises, including the corresponding schemes on information flows; (f) identify the contribution of market-based measures in coping with electricity crises, in particular demand-side and supply-side measures; (g) identify possible non-market-based measures to be implemented in electricity crises, specifying the triggers, conditions and procedures for their implementation, and indicating how they comply with the requirements laid down in Article 16 and with regional and bilateral measures; (h) provide a framework for manual load shedding, stipulating the circumstances in which loads are to be shed and, with regard to public safety and personal security, specifying which categories of electricity users are, in accordance with national law, entitled to receive special protection against disconnection, justifying the need for such protection, and specifying how the transmission system operators and distribution system operators of the Member States concerned are to decrease consumption; (i) describe the mechanisms used to inform the public about electricity crises; (j) describe the national measures necessary to implement and enforce the regional and, where applicable, bilateral measures agreed pursuant to Article 12; (k) include information on related and necessary plans for developing the future grid that will help to cope with the consequences of identified electricity crisis scenarios. 2. National measures shall take full account of the regional and, where applicable, bilateral measures agreed pursuant to Article 12 and shall endanger neither the operational security or safety of the transmission system, nor the security of electricity supply of other Member States. Article 12 Content of risk-preparedness plans as regards regional and bilateral measures 1. In addition to the national measures referred to in Article 11, the risk-preparedness plan of each Member State shall include regional and, where applicable, bilateral measures to ensure that electricity crises with a cross-border impact are properly prevented or managed. Regional measures shall be agreed within the region concerned between Member States that have the technical ability to provide each other assistance in accordance with Article 15. For that purpose, Member States may also form subgroups within a region. Bilateral measures shall be agreed between Member States which are directly connected but are not within the same region. Member States shall ensure consistency between regional and bilateral measures. Regional and bilateral measures shall include at least: (a) the designation of a crisis coordinator; (b) mechanisms to share information and cooperate; (c) coordinated measures to mitigate the impact of an electricity crisis, including a simultaneous electricity crisis, for the purpose of assistance in accordance with Article 15; (d) procedures for carrying out annual or biennial tests of the risk-preparedness plans; (e) the trigger mechanisms of non-market-based measures that are to be activated in accordance with Article 16(2). 2. The Member States concerned shall agree the regional and bilateral measures to be included in the risk-preparedness plan after consulting the relevant regional coordination centres. The Commission may have a facilitating role in the preparation of the agreement on regional and bilateral measures. The Commission may request ACER and the ENTSO for Electricity to provide technical assistance to Member States with a view to facilitating such an agreement. At least eight months before the deadline for the adoption or the updating of the risk-preparedness plan, the competent authorities shall report on the agreements reached to the ECG. If the Member States are not able to reach an agreement, the competent authorities concerned shall inform the Commission of the reasons for such disagreement. In such a case the Commission shall propose measures including a cooperation mechanism for the conclusion of an agreement on regional and bilateral measures. 3. With the involvement of relevant stakeholders, the competent authorities of the Member States of each region shall periodically test the effectiveness of the procedures developed in risk-preparedness plans for preventing electricity crises, including the mechanisms referred to in point (b) of paragraph 1, and carry out biennial simulations of electricity crises, in particular testing those mechanisms. Article 13 Commission assessment of the risk-preparedness plans 1. Within four months of the notification of the adopted risk-preparedness plan by the competent authority, the Commission shall assess the plan taking duly into account the views expressed by the ECG. 2. The Commission shall, after consulting the ECG, issue a non-binding opinion, setting out detailed reasons, and submit it to the competent authority, with a recommendation to review its risk-preparedness plan where that plan: (a) is not effective to mitigate the risks identified in the electricity crisis scenarios; (b) is inconsistent with the electricity crisis scenarios identified or with the risk-preparedness plan of another Member State; (c) does not comply with the requirements laid down in Article 10(2); (d) sets out measures that are likely to jeopardise the security of electricity supply of other Member States; (e) unduly distorts competition or the effective functioning of the internal market; or (f) does not comply with the provisions of this Regulation or other provisions of Union law. 3. Within three months of receipt of the Commission's opinion referred to in paragraph 2, the competent authority concerned shall take full account of the Commission's recommendation and shall either notify the amended risk-preparedness plan to the Commission or notify the Commission of the reasons why it objects to the recommendation. 4. In the event that the competent authority objects to the Commission's recommendation, the Commission may, within four months of receipt of the notification of the competent authority's reasons for objection, withdraw its recommendation or convene a meeting with the competent authority and, where the Commission considers it to be necessary, the ECG, in order to assess the issue. The Commission shall set out detailed reasons for requesting any modifications to the risk-preparedness plan. Where the final position of the competent authority concerned diverges from the Commission's detailed reasons, that competent authority shall provide the Commission with the reasons for its position within two months of receipt of the Commission's detailed reasons. CHAPTER IV Managing electricity crises Article 14 Early warning and declaration of an electricity crisis 1. Where a seasonal adequacy assessment or other qualified source provides concrete, serious and reliable information that an electricity crisis may occur in a Member State, the competent authority of that Member State shall, without undue delay, issue an early warning to the Commission, the competent authorities of the Member States within the same region and, where they are not in the same region, the competent authorities of the directly connected Member States. The competent authority concerned shall also provide information on the causes of the possible electricity crisis, on measures planned or taken to prevent an electricity crisis and on the possible need for assistance from other Member States. The information shall include the possible impacts of the measures on the internal electricity market. The Commission shall provide that information to the ECG. 2. When confronted with an electricity crisis, the competent authority shall, after consulting the transmission system operator concerned, declare an electricity crisis and inform the competent authorities of the Member States within the same region and, where they are not in the same region, the competent authorities of directly connected Member States, as well as the Commission, without undue delay. That information shall include the causes of the deterioration of the electricity supply situation, the reasons for declaring an electricity crisis, the measures planned or taken to mitigate it and the need for any assistance from other Member States. 3. Where they consider the information provided pursuant to paragraph 1 or 2 to be insufficient, the Commission, the ECG or the competent authorities of the Member States within the same region and, where they are not in the same region, the competent authorities of directly connected Member States may request the Member State concerned to provide additional information. 4. Where a competent authority issues an early warning or declares an electricity crisis, the measures set out in the risk-preparedness plan shall be followed to the fullest extent possible. Article 15 Cooperation and assistance 1. Member States shall act and cooperate in a spirit of solidarity in order to prevent or manage electricity crises. 2. Where they have the necessary technical ability, Member States shall offer each other assistance by means of regional or bilateral measures that have been agreed pursuant to this Article and to Article 12 before that assistance is provided. To that end, and with the purpose of protecting public safety and personal security, Member States shall agree on regional or bilateral measures of their choice in order to deliver electricity in a coordinated manner. 3. Member States shall agree on the necessary technical, legal and financial arrangements for the implementation of the regional or bilateral measures before assistance is offered. Such arrangements shall specify, inter alia, the maximum quantity of electricity to be delivered at regional or bilateral level, the trigger for any assistance and for suspension of assistance, how the electricity will be delivered, and provisions on fair compensation between Member States in accordance with paragraphs 4, 5 and 6. 4. Assistance shall be subject to a prior agreement between the Member States concerned with regard to fair compensation, which shall cover at least: (a) the cost of the electricity delivered into the territory of the Member State requesting assistance as well as the associated transmission costs; and (b) any other reasonable costs incurred by the Member State providing assistance, including as regards reimbursement for assistance prepared without effective activation, as well as any costs resulting from judicial proceedings, arbitration proceedings or similar proceedings and settlements. 5. Fair compensation pursuant to paragraph 4 shall include, inter alia, all reasonable costs that the Member State providing assistance incurs from an obligation to pay compensation by virtue of fundamental rights guaranteed by Union law and by virtue of the applicable international obligations when implementing the provisions of this Regulation on assistance and further reasonable costs incurred from the payment of compensation pursuant to national compensation rules. 6. The Member State requesting assistance shall promptly pay, or ensure the prompt payment of fair compensation to the Member State providing assistance. 7. The Commission shall, by 5 January 2020, after consulting the ECG and ACER, provide for non-binding guidance on the key elements of the fair compensation referred to in paragraphs 3 to 6 and other key elements of the technical, legal and financial arrangements referred to in paragraph 3 as well as on general principles of mutual assistance referred to in paragraph 2. 8. In the event of an electricity crisis in which Member States have not yet agreed on regional or bilateral measures and technical, legal and financial arrangements pursuant to this Article, Member States shall agree on ad hoc measures and arrangements in order to apply this Article, including as regards fair compensation pursuant to paragraphs 4, 5 and 6. Where a Member State requests assistance before such ad hoc measures and arrangements have been agreed, it shall undertake, prior to receiving assistance, to pay fair compensation in accordance with paragraphs 4, 5 and 6. 9. Member States shall ensure that the provisions of this Regulation on assistance are implemented in accordance with the Treaties, the Charter of Fundamental Rights of the European Union and other applicable international obligations. They shall take the necessary measures to that end. Article 16 Compliance with market rules 1. Measures taken to prevent or mitigate electricity crises shall comply with the rules governing the internal electricity market and system operation. 2. Non-market-based measures shall be activated in an electricity crisis only as a last resort if all options provided by the market have been exhausted or where it is evident that market-based measures alone are not sufficient to prevent a further deterioration of the electricity supply situation. Non-market-based measures shall not unduly distort competition and the effective functioning of the internal electricity market. They shall be necessary, proportionate, non-discriminatory and temporary. The competent authority shall inform relevant stakeholders in its Member State of the application of any non-market-based measures. 3. Transaction curtailment including curtailment of already allocated cross zonal capacity, limitation of provision of cross zonal capacity for capacity allocation or limitation of provision of schedules shall be initiated only in accordance with Article 16(2) of Regulation (EU) 2019/943, and the rules adopted to implement that provision. CHAPTER V Evaluation and monitoring Article 17 Ex post evaluation 1. As soon as possible and in any event three months after the end of an electricity crisis, the competent authority of the Member State that declared the electricity crisis shall provide the ECG and the Commission with an ex post evaluation report, after having consulted the regulatory authority, where the regulatory authority is not the competent authority. 2. The ex post evaluation report shall include at least: (a) a description of the event that triggered the electricity crisis; (b) a description of any preventive, preparatory and mitigating measures taken and an assessment of their proportionality and effectiveness; (c) an assessment of the cross-border impact of the measures taken; (d) an account of the assistance prepared, with or without effective activation, provided to or received from neighbouring Member States and third countries; (e) the economic impact of the electricity crisis and the impact of the measures taken on the electricity sector to an extent allowed by data available at the time of the assessment, in particular the volumes of energy non-served and the level of manual demand disconnection (including a comparison between the level of voluntary and forced demand disconnection); (f) reasons justifying the application of any non-market-based measures; (g) any possible improvements or proposed improvements to the risk-preparedness plan; (h) an overview of possible improvements to grid development in cases where insufficient network development caused or contributed to the electricity crisis. 3. Where they consider the information provided in the ex post evaluation report to be insufficient, the ECG and the Commission may request the competent authority concerned to provide additional information. 4. The competent authority concerned shall present the results of the ex post evaluation at a meeting of the ECG. Those results shall be reflected in the updated risk-preparedness plan. Article 18 Monitoring 1. In addition to carrying out other tasks set out in this Regulation, the ECG shall discuss: (a) the results of the 10-year network development plan in electricity prepared by the ENTSO for Electricity; (b) the coherence of the risk-preparedness plans, adopted by the competent authorities following the procedure referred to in Article 10; (c) the results of the European resource adequacy assessments carried out by the ENTSO for Electricity as referred to in Article 23(4) of Regulation (EU) 2019/943; (d) the performance of Member States in the area of security of electricity supply taking into account at least the indicators calculated in the European resource adequacy assessment, namely the expected energy non-served and loss of load expectation; (e) the results of the seasonal adequacy assessments referred to in Article 9(2); (f) the information received from the Member States pursuant to Article 7(4); (g) the results of the ex post evaluation referred to in Article 17(4); (h) the methodology for short-term adequacy assessment referred to in Article 8; (i) the methodology for identifying regional electricity crisis scenarios referred to in Article 5. 2. The ECG may issue recommendations to the Member States as well as to the ENTSO for Electricity related to the matters referred to in paragraph 1. 3. ACER shall, on an ongoing basis, monitor the security of electricity supply measures and shall report regularly to the ECG. 4. By 1 September 2025, the Commission shall, on the basis of the experience gained in the application of this Regulation, evaluate the possible means by which to enhance security of electricity supply at Union level and submit a report to the European Parliament and to the Council on the application of this Regulation, including, where necessary, legislative proposals to amend this Regulation. Article 19 Treatment of confidential information 1. Member States and competent authorities shall implement the procedures referred to in this Regulation in accordance with the applicable rules, including national rules relating to the handling of confidential information and processes. If the implementation of those rules results in information not being disclosed, inter alia as part of risk-preparedness plans, the Member State or authority may provide a non-confidential summary thereof, and shall do so upon request. 2. The Commission, ACER, the ECG, the ENTSO for Electricity, Member States, competent authorities, regulatory authorities and other relevant bodies, entities or persons, which receive confidential information pursuant to this Regulation, shall ensure the confidentiality of sensitive information. CHAPTER VI Final provisions Article 20 Cooperation with the Energy Community Contracting Parties Where the Member States and the Energy Community Contracting Parties cooperate in the area of security of electricity supply, such cooperation may include defining an electricity crisis, the process of the identification of electricity crisis scenarios and the establishment of risk-preparedness plans so that no measures are taken that endanger the security of electricity supply of the Member States, Energy Community Contracting Parties or the Union. In that respect, the Energy Community Contracting Parties may, at the invitation of the Commission, participate in the ECG with regard to all matters with which they are concerned. Article 21 Derogation Until Cyprus is directly connected with another Member State, Articles 6 and 12 and Article 15(2) to (9) shall not apply either between Cyprus and other Member States, or to the ENTSO for Electricity as regards Cyprus. Cyprus and relevant other Member States may develop, with the support of the Commission, measures and procedures alternative to those provided for in Articles 6 and 12 and Article 15(2) to (9), provided that such alternative measures and procedures do not affect the effective application of this Regulation between the other Member States. Article 22 Transitional provision pending the establishment of regional coordination centres Until the date on which regional coordination centres are established pursuant to Article 35 of Regulation (EU) 2019/943, regions shall refer either to a Member State or to a group of Member States located in the same synchronous area. Article 23 Repeal Directive 2005/89/EC is repealed. Article 24 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 5 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 288, 31.8.2017, p. 91. (2) OJ C 342, 12.10.2017, p. 79. (3) Position of the European Parliament of 26 March 2019 (not yet published in the Official Journal) and decision of the Council of 22 May 2019. (4) Regulation (EU) 2019/943 of the European Parliament and of the Council of 5 June 2019 on the internal market for electricity (see page 54 of this Official Journal). (5) Directive (EU) 2019/944 of the European Parliament and of the Council of 5 June 2019 on common rules for the internal market for electricity and amending Directive 2012/27/EU (see page 125 of this Official Journal). (6) Directive 2005/89/EC of the European Parliament and of the Council of 18 January 2006 concerning measures to safeguard security of electricity supply and infrastructure investment (OJ L 33, 4.2.2006, p. 22). (7) Commission Regulation (EU) 2017/1485 of 2 August 2017 establishing a guideline on electricity transmission system operation (OJ L 220, 25.8.2017, p. 1). (8) Commission Regulation (EU) 2017/2196 of 24 November 2017 establishing a network code on electricity emergency and restoration (OJ L 312, 28.11.2017, p. 54). (9) Commission Decision of 15 November 2012 setting up the Electricity Coordination Group (OJ C 353, 17.11.2012, p. 2). (10) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1). (11) Council Directive 2008/114/EC of 8 December 2008 on the identification and designation of European critical infrastructures and the assessment of the need to improve their protection (OJ L 345, 23.12.2008, p. 75). (12) Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924). (13) Regulation (EU) 2019/942 of the European Parliament and of the Council of 5 June 2019 establishing a European Union Agency for the Cooperation of Energy Regulators (see page 22 of this Official Journal). (14) Regulation (EU) 2017/1938 of the European Parliament and of the Council of 25 October 2017 concerning measures to safeguard the security of gas supply and repealing Regulation (EU) No 994/2010 (OJ L 280, 28.10.2017, p. 1). ANNEX TEMPLATE FOR RISK-PREPAREDNESS PLAN The following template shall be completed in English. General information — Name of the competent authority responsible for the preparation of this plan — Member States in the region 1. SUMMARY OF THE ELECTRICITY CRISIS SCENARIOS Describe briefly the electricity crisis scenarios identified at regional and national level in accordance with the procedure laid down in Articles 6 and 7, including the description of the assumptions applied. 2. ROLES AND RESPONSIBILITIES OF THE COMPETENT AUTHORITY Define the role and responsibilities of the competent authority and the bodies to which tasks have been delegated. Describe which tasks, if any, have been delegated to other bodies. 3. PROCEDURES AND MEASURES IN THE ELECTRICITY CRISIS 3.1. National procedures and measures (a) Describe procedures to be followed in the cases of an electricity crisis, including the corresponding schemes on information flows; (b) Describe preventive and preparatory measures; (c) Describe measures to mitigate electricity crises, in particular demand-side and supply-side measures, whilst indicating in which circumstances such measures can be used especially the trigger of each measure. Where non-market-based measures are considered, they must be duly justified in light of the requirements laid down in Article 16 and must comply with regional and, where applicable, bilateral measures; (d) Provide a framework for manual load shedding, stipulating under which circumstances loads are to be shed. Specify with regard to public safety and personal security which categories of electricity users are entitled to receive special protection against disconnection, and justify the need for such protection. Specify how the transmission system operators and the distribution system operators should act in order to decrease the consumption; (e) Describe the mechanisms used to inform the public about the electricity crisis. 3.2. Regional and bilateral procedures and measures (a) Describe the agreed mechanisms for cooperation within the region and for ensuring appropriate coordination before and during the electricity crisis, including the decision-making procedures for appropriate reaction at regional level; (b) Describe any regional and bilateral measures that have been agreed, including any necessary technical, legal and financial arrangements for the implementation of those measures. When describing such arrangements, provide information on, inter alia, the maximum quantities of electricity to be delivered at regional or bilateral level, the trigger for the assistance and possibility to request its suspension, how the electricity will be delivered, and the provisions on fair compensation between Member States. Describe the national measures necessary to implement and enforce the regional and bilateral measures agreed; (c) Describe the mechanisms in place for cooperation and for coordinating actions, before and during the electricity crisis, with other Member States outside of the region as well as with third countries within the relevant synchronous area. 4. CRISIS COORDINATOR Indicate and define the role of the crisis coordinator. Specify the contact details. 5. STAKEHOLDER CONSULTATIONS In accordance with Article 10(1), describe the mechanism used for and the results of the consultations carried out, for the development of this plan, with: (a) relevant electricity and natural gas undertakings, including relevant producers or their trade bodies; (b) relevant organisations representing the interests of non-industrial electricity customers; (c) relevant organisations representing the interests of industrial electricity customers; (d) regulatory authorities; (e) the transmission system operators; (f) relevant distribution system operators. 6. EMERGENCY TESTS (a) Indicate the calendar for the biennial regional (and, if applicable also national) real time response simulations of electricity crises; (b) In accordance with point (d) of Article 12(1), indicate procedures agreed and the actors involved. For the updates of the plan: briefly describe the tests carried out since the last plan was adopted and the main results. Indicate which measures have been adopted as a result of those tests.

Risk-preparedness in the electricity sector Risk-preparedness in the electricity sector SUMMARY OF: Regulation (EU) 2019/941 on risk-preparedness in the electricity sector WHAT IS THE AIM OF THE REGULATION? It aims to: better identify possible electricity crises*;prepare crisis-management plans; andhandle crises when they occur. It establishes a common methodology and lays down rules for cooperation between EU countries with a view to preventing, preparing for and managing electricity crises in a spirit of solidarity and transparency, while respecting the requirements for a competitive internal market for electricity. It repeals Directive 2005/89/EC which set out the measures EU countries had to take to ensure security of electricity supply in general. KEY POINTS The European Network of Transmission System Operators for Electricity (ENTSO-E): submits, by 5 January 2020 after wide-ranging consultation, to the Agency for the Cooperation of Energy Regulators (ACER) for approval and/or amendment methodology: for identifying regional electricity crisis scenarios in relation to system adequacy, system security and fuel security;for assessing seasonal and short-term (monthly, week-ahead and day-ahead) electricity system adequacy when confronted by issues such as severe weather; identifies, within 6 months of approval of the first methodology, the most relevant electricity crisis scenarios for each region; reassesses these regional crisis scenarios every 4 years; updates and improves both methodologies when significant new information becomes available; carries out seasonal adequacy assessments, publishing those for winter by 1 December and for summer by 1 June each year. The methodology for identifying regional electricity crisis scenarios: takes account at least the following risks: rare and extreme natural hazards;accidental hazards;consequential hazards, including malicious attacks and fuel shortages; includes the following: consideration of all relevant national and regional circumstances;interaction and correlation of cross-border risks;simulations of simultaneous electricity crises;ranking of risks according to their impact and probability;principles for handling sensitive information while ensuring transparency. is published on the ENTSO-E and ACER websites. Competent authorities, appointed by EU countries by 5 January 2020: are responsible for, and cooperate with each other, in implementing the tasks set out in the legislation; cooperate with transmission and distribution system operators, regulatory authorities,ENTSO-E, regional coordination centres and other relevant stakeholders as necessary; identify, within 4 months of the identification of the regional electricity crisis scenarios, the most relevant national electricity crisis scenarios and update these every 4 years; establish risk-preparedness plans, based on the identified regional and national crisis scenarios. The plans, which will be assessed by the European Commission, after consulting the Electricity Coordination Group (ECG), follow a template setting out information such as: summary of the electricity crisis scenarios;roles and responsibilities of competent authority;procedures and measures in an electricity crisis (e.g. national, regional and bilateral);appointment and defined role of a crisis coordinator;consultation with stakeholders, such as transmission and distribution operators and electricity and natural gas companies;emergency testing; issue immediately an early warning* to the Commission and neighbouring EU countries when reliable information indicates an electricity crisis may occur on its territory, and provide relevant information; declare an electricity crisis and inform the Commission and neighbouring EU countries; submit an evaluation report, at the latest 3 months after the end of an electricity crisis, to the Commission and the ECG, describing the event and assessing its impact, measures taken and possible improvements. Monitoring The ECG discusses issues such as the coherence of the risk-preparedness plans, the results of the adequacy assessments and the performance of EU countries in the area of security of electricity supply*. The ACER monitors security of electricity supply measures and reports regularly to the ECG. The Commission, by 1 September 2025, submits a report to the European Parliament and the Council on how to improve security of electricity supply in the EU. FROM WHEN DOES THE REGULATION APPLY? It has applied since 4 July 2019. BACKGROUND Electricity crises can occur for many reasons, for example due to extreme weather conditions, malicious attacks or fuel shortages. Where crisis situations occur, they often have a cross-border effect. Large-scale incidents, such as cold spells, heat waves or cyberattacks can affect several EU countries at the same time. The regulation is one of the 8 pieces of legislation in the ‘Clean energy for all Europeans’ package the Commission tabled in November 2016. This contributes to shaping the Energy Union, keeping the EU competitive and fulfilling its climate change Paris Agreement commitments. KEY TERMS Electricity crisis: existing or imminent situation where there is a significant electricity shortage. Early warning: provision of concrete, serious, reliable information indicating that an event may occur which is likely to result in a significant deterioration of the electricity supply situation and to lead to an electricity crisis. Security of electricity supply: ability of an electricity system to guarantee supply to customers with a clearly established level of performance. MAIN DOCUMENT Regulation (EU) 2019/941 of the European Parliament and of the Council of 5 June 2019 on risk-preparedness in the electricity sector and repealing Directive 2005/89/EC (OJ L 158, 14.6.2019, pp. 1-21) RELATED DOCUMENTS Regulation (EU) 2019/942 of the European Parliament and of the Council of 5 June 2019 establishing a European Union Agency for the Cooperation of Energy Regulators (OJ L 158, 14.6.2019, pp. 22-53) Regulation (EU) 2019/943 of the European Parliament and of the Council of 5 June 2019 on the internal market for electricity (OJ L 158, 14.6.2019, pp. 54-124) Directive (EU) 2019/944 of the European Parliament and of the Council of 5 June 2019 on common rules for the internal market for electricity and amending Directive 2012/27/EU (OJ L 158, 14.6.2019, pp. 125-199) last update 24.07.2019

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5.6.2020 EN Official Journal of the European Union L 177/1 REGULATION (EU) 2020/740 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 May 2020 on the labelling of tyres with respect to fuel efficiency and other parameters, amending Regulation (EU) 2017/1369 and repealing Regulation (EC) No 1222/2009 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 194(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The Union is committed to building an Energy Union with a forward‐looking climate policy. Fuel efficiency is a crucial element of the Union’s 2030 climate and energy policy framework and is key to moderating energy demand. (2) The Commission has reviewed Regulation (EC) No 1222/2009 of the European Parliament and of the Council (3) and has identified the need to update its provisions to improve its effectiveness. (3) It is appropriate to replace Regulation (EC) No 1222/2009 in order to clarify and update some of its provisions, taking into account technological progress with regard to tyres. (4) The transport sector accounts for a third of the Union’s energy consumption. Road transport was responsible for about 22 % of the Union’s total greenhouse gas emissions in 2015. Tyres, mainly because of their rolling resistance, account for 20 to 30 % of the fuel consumption of vehicles. A reduction in the rolling resistance of tyres would therefore contribute significantly to the fuel efficiency of road transport and thus to the reduction of greenhouse gas emissions and to the decarbonisation of the transport sector. (5) In order to meet the challenge of reducing the CO2 emissions of road transport, it is appropriate that Member States, in cooperation with the Commission, provide for incentives to innovate with regard to fuel‐efficient and safe C1 tyres, C2 tyres and C3 tyres. (6) Tyres are characterised by a number of interrelated parameters. Improving one parameter, such as rolling resistance, may have an adverse impact on other parameters, such as wet grip, while improving wet grip performance may have an adverse impact on external rolling noise. Tyre manufacturers should be encouraged to optimise all parameters beyond the current standards. (7) Fuel‐efficient tyres can be cost‐effective, since the fuel savings that they generate more than offset the increased purchase price resulting from the higher production costs of such tyres. (8) Regulation (EC) No 661/2009 of the European Parliament and of the Council (4) lays down minimum requirements for the rolling resistance of tyres. Technological developments make it possible to reduce the energy losses that are due to tyre rolling resistance significantly beyond those minimum requirements. To reduce the environmental impact of road transport, it is therefore appropriate to update the provisions on the labelling of tyres to encourage end-users to purchase more fuel‐efficient tyres by providing them with harmonised information on the rolling resistance parameter. (9) Improving the labelling of tyres will enable consumers to obtain more relevant and more comparable information on fuel efficiency, safety and noise and to take cost‐effective and environmentally friendly decisions when purchasing tyres. (10) Traffic noise is a significant nuisance and has a harmful effect on health. Regulation (EC) No 661/2009 lays down minimum requirements for the external rolling noise of tyres. Technological developments make it possible to reduce external rolling noise significantly beyond those minimum requirements. To reduce traffic noise, it is therefore appropriate to update the provisions on the labelling of tyres to encourage end-users to purchase tyres with lower external rolling noise by providing them with harmonised information on the external rolling noise parameter. (11) The provision of harmonised information on external rolling noise also facilitates the implementation of measures to limit traffic noise and contributes to increased awareness of the effect of tyres on traffic noise within the framework of Directive 2002/49/EC of the European Parliament and of the Council (5). (12) Regulation (EC) No 661/2009 also lays down minimum requirements for the wet grip of tyres. Technological developments make it possible to improve wet grip significantly beyond those minimum requirements, and thus to reduce wet braking distances. To improve road safety, it is therefore appropriate to update the provisions on the labelling of tyres to encourage end-users to purchase tyres with higher wet grip performance by providing them with harmonised information on the wet grip parameter. (13) In order to ensure alignment with the international framework, Regulation (EC) No 661/2009 refers to Regulation No 117 of the Economic Commission for Europe of the United Nations (UNECE) (6), which sets out the relevant measurement methods for the rolling resistance, external rolling noise, and wet and snow grip performance of tyres. (14) Information on the performance of tyres that are specifically designed for use in severe snow and ice conditions should be included on the tyre label. Information on snow grip performance should be based on Regulation No 117 of the Economic Commission for Europe of the United Nations (UNECE), in its most up‐to‐date version applicable to the Union, (UNECE Regulation No 117), and the ‘Alpine Symbol’ pictogram contained therein should be included on the tyre label of a tyre which satisfies the minimum snow grip index values set out in that Regulation. Information on ice grip performance should, once the standard is formally adopted, be based on ISO standard ISO 19447 and the ice grip pictogram should be included on the tyre label of a tyre which satisfies the minimum ice grip index values set out in that ISO standard. Until adoption of ISO standard ISO 19447, ice grip performance should be assessed against reliable, accurate and reproducible methods, which take into account the generally recognised state of the art. The tyre label of a tyre which satisfies the minimum ice grip performance standards should show the ice grip pictogram set out in Annex I. (15) The abrasion of tyres during use is a significant source of microplastics, which are harmful to the environment and human health. The Commission’s Communication ‘A European Strategy for Plastics in a Circular Economy’ therefore mentions the need to address the unintentional release of microplastics from tyres, inter alia through information measures such as labelling and through minimum requirements for tyres. Linked to tyre abrasion is the concept of mileage, namely the number of kilometres a tyre will last before it needs to be replaced because of tread wear. In addition to tyre abrasion and tread wear, the lifespan of a tyre depends on a range of factors, such as the wear resistance of the tyre, including the compound, tread pattern and structure, road conditions, maintenance, tyre pressure and driving behaviour. (16) However, a suitable testing method to measure tyre abrasion and mileage is not currently available. Therefore, the Commission should mandate the development of such a testing method, taking into full consideration the state of the art and internationally developed or proposed standards and regulations, as well as the work carried out by industry. (17) Re‐treaded tyres constitute a substantial part of the market for heavy‐duty vehicle tyres. The re‐treading of tyres extends their lifespan and contributes to circular economy objectives, such as waste reduction. Applying labelling requirements to such tyres would bring substantial energy savings. This Regulation should provide for the future inclusion of a suitable testing method to measure the performance of re‐treaded tyres, which is not currently available. (18) The energy label provided for under Regulation (EU) 2017/1369 of the European Parliament and of the Council (7), which ranks the energy consumption of products on a scale from ‘A’ to ‘G’, is recognised by over 85 % of Union consumers as a clear and transparent information tool and has proven to be effective in promoting more efficient products. The tyre label should be of the same design to the extent possible, while recognising the specificities of tyre parameters. (19) The provision of comparable information on tyre parameters in the form of a standard tyre label is likely to influence purchasing decisions by end-users in favour of more fuel‐efficient, longer‐lasting, safer and quieter tyres. This, in turn, is likely to encourage tyre manufacturers to optimise tyre parameters, which would pave the way for a more sustainable consumption and production of tyres. (20) The need for greater information on fuel efficiency and other parameters is relevant for all end-users, including purchasers of replacement tyres, purchasers of tyres fitted on new vehicles, and fleet managers and transport undertakings, who cannot easily compare the parameters of different tyre brands in the absence of a labelling and harmonised testing regime. It is therefore appropriate to require that a tyre label be provided for all tyres offered with or fitted on vehicles. (21) Currently, tyre labels are required for tyres for cars (C1 tyres) and vans (C2 tyres) but not for heavy‐duty vehicles (C3 tyres). C3 tyres consume more fuel and cover more kilometres per year than C1 tyres or C2 tyres, and therefore the potential to reduce fuel consumption and greenhouse gas emissions from heavy‐duty vehicles is significant. Therefore, C3 tyres should be included in the scope of this Regulation. Including C3 tyres fully in the scope of this Regulation is also in line with Regulation (EU) 2018/956 of the European Parliament and of the Council (8), which provides for the monitoring and reporting of CO2 emissions from and fuel consumption of new heavy‐duty vehicles, and with Regulation (EU) 2019/1242 of the European Parliament and of the Council (9), which sets CO2 emission performance standards for new heavy‐duty vehicles. (22) Many end-users make tyre purchasing decisions without seeing the actual tyre and therefore do not see the tyre label affixed to it. In such situations, end-users should be shown the tyre label before taking their purchasing decisions. The display of a tyre label on tyres at the point of sale, as well as in technical promotional material, should ensure that distributors as well as potential end-users receive harmonised information on the relevant tyre parameters at the time and place of the purchasing decision. (23) Some end-users make tyre purchasing decisions before arriving at the point of sale, or purchase tyres by mail order or on the internet. To ensure that those end-users can also make an informed choice on the basis of harmonised information on, inter alia, fuel efficiency, wet grip and external rolling noise, tyre labels should be displayed in all technical promotional material and visual advertisements for specific tyre types, including where such material is made available on the internet. Where visual advertisements pertain to a tyre family, and not only to a specific tyre type, the tyre label does not have to be shown. (24) Potential end-users should be provided with information explaining each component of the tyre label and its relevance. That information should be provided in all technical promotional material, for example on suppliers’ websites, but should not be required in visual advertisements. Technical promotional material should not be understood to include advertisements via billboards, newspapers, magazines or radio or television broadcasts. (25) Without prejudice to the market surveillance obligations of Member States or to the obligation of suppliers to check product conformity, suppliers should make the requisite product compliance information electronically available in the product database. The information that is relevant to consumers and distributors should be made publicly available in the public part of the product database. That information should be made available as open data so as to give mobile application developers and comparison tools the opportunity to use it. Easy direct access to the public part of the product database should be facilitated by user‐oriented tools that are included on the printed tyre label, such as a dynamic quick response code (QR code). (26) The compliance part of the product database should be subject to strict data protection rules. The required specific parts of the technical documentation in the compliance part of the product database should be made available both to market surveillance authorities and to the Commission. Where technical information is too sensitive to include it in the category of technical documentation, market surveillance authorities should have access to that information when necessary in accordance with the duty of cooperation on suppliers or by way of additional parts of the technical documentation uploaded to the product database by suppliers on a voluntary basis. (27) The sale of tyres through internet sales platforms, rather than directly from suppliers, is growing. Therefore, hosting service providers should enable the display of the tyre label and product information sheet provided by the supplier close to the price indication. They should inform the distributor of the obligation to display the tyre label and product information sheet, but should not be responsible for the accuracy or content of that tyre label or product information sheet. The obligations imposed on hosting service providers under this Regulation should remain limited to what is reasonable and should not amount to a general obligation to monitor the information that they store or to actively seek facts or circumstances indicating activities that do not comply with the requirements of this Regulation. However, Article 14(1) of Directive 2000/31/EC of the European Parliament and of the Council (10) requires hosting service providers that wish to benefit from the liability exemption contained in that provision to act expeditiously to remove or disable access to information that they store at the request of recipients of their services where such information does not comply with the requirements of this Regulation, such as those relating to missing, incomplete or incorrect tyre labels or product information sheets. They should do so as soon as they obtain actual knowledge of such information or, as regards claims for damages, as soon as they become aware of such information, for example through specific information provided by a market surveillance authority. Suppliers selling directly to end-users via their own website are subject to the same distance selling obligations as distributors. (28) Rolling resistance, wet grip, external rolling noise and other parameters should be measured in accordance with reliable, accurate and reproducible methods that take into account the generally recognised state‐of‐the‐art measurement and calculation methods. As far as possible, such methods should reflect average consumer behaviour and be robust in order to deter both intentional and unintentional circumvention. Tyre labels should reflect the comparative performance of the tyres in actual use, within the constraints arising from the need for reliable, accurate and reproducible laboratory testing, in order to enable end-users to compare different tyres and to limit testing costs for manufacturers. (29) Where they have sufficient reason to believe that a supplier has not ensured the accuracy of the tyre label and in order to give additional confidence to consumers, national authorities as defined in point (37) of Article 3 of Regulation (EU) 2018/858 of the European Parliament and of the Council (11) should check whether the classes for rolling resistance, wet grip and external rolling noise displayed on the tyre label, as well as the pictograms for other parameters, correspond to the documentation provided by the supplier based on test results and calculations. Such checks may take place during the type‐approval process and do not necessarily require the physical testing of the tyre. (30) Compliance by suppliers, wholesalers, dealers and other distributors with the provisions on the labelling of tyres is essential in order to ensure a level playing field in the Union. Member States should therefore monitor such compliance through regular ex‐post controls and market surveillance in accordance with Regulation (EU) 2019/1020 of the European Parliament and of the Council (12). (31) In order to facilitate the monitoring of compliance, to provide a useful tool to end-users and to allow alternative ways for distributors to receive product information sheets, tyres should be included in the product database established under Regulation (EU) 2017/1369. That Regulation should therefore be amended accordingly. (32) In order for end-users to have confidence in the tyre label, other labels that mimic the tyre label should not be allowed. For the same reason, other labels, marks, symbols or inscriptions that are likely to mislead or confuse end-users with respect to the parameters covered by the tyre label should not be allowed. (33) The penalties applicable to infringements of this Regulation and of the delegated acts adopted pursuant thereto should be effective, proportionate and dissuasive. (34) In order to promote energy efficiency, climate change mitigation, road safety and environmental protection, Member States should be able to create incentives for the use of energy‐efficient and safe tyres. Member States are free to decide on the nature of such incentives. Such incentives should comply with Union State aid rules and should not constitute unjustifiable market barriers. This Regulation does not prejudice the outcome of any State aid procedures that may be undertaken in accordance with Articles 107 and 108 of the Treaty on the Functioning of the European Union (TFEU) in respect of such incentives. (35) In order to amend the content and format of the tyre label, to introduce requirements with respect to re‐treaded tyres, tyre abrasion and mileage, and to adapt the Annexes to technological progress, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law‐Making (13). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (36) Once reliable, accurate and reproducible methods to test and measure tyre abrasion and mileage are available, the Commission should assess the feasibility of adding information on tyre abrasion and mileage to the tyre label. When proposing a delegated act to add tyre abrasion and mileage to the tyre label, the Commission should take that assessment into account, and should collaborate closely with industry, relevant standardisation organisations, such as the European Committee for Standardization (CEN), the United Nations Economic Commission for Europe (UNECE) or the International Organisation for Standardisation (ISO), and representatives of other stakeholders interested in the development of suitable testing methods. Information on tyre abrasion and mileage should be unambiguous and should not negatively affect the clear intelligibility and effectiveness of the tyre label as a whole towards end-users. Such information would also enable end-users to make an informed choice with regard to tyres, their lifespan and the unintentional release of microplastics. This would help protect the environment and at the same time allow end-users to estimate the operating costs of tyres over a longer period. (37) Tyres which were already placed on the market before the date of application of this Regulation should not need to be provided with a new tyre label. (38) The size of the tyre label should remain the same as that set out in Regulation (EC) No 1222/2009. Details regarding snow grip and ice grip, and the QR code, should be included on the tyre label. (39) The Commission should carry out an evaluation of this Regulation. In accordance with paragraph 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law‐Making, that evaluation should be based on efficiency, effectiveness, relevance, coherence and value added and should provide the basis for impact assessments of options for further action. (40) Since the objective of this Regulation, namely to increase safety, the protection of health, and the economic and environmental efficiency of road transport by providing information to end-users to allow them to choose more fuel‐efficient, longer‐lasting, safer and quieter tyres, cannot be sufficiently achieved by the Member States because it requires harmonised information for end-users, but can rather, by reason of the need for a harmonised regulatory framework and a level playing field for manufacturers, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). A Regulation remains the appropriate legal instrument as it imposes clear and detailed rules which preclude divergent transposition by Member States and thus ensures a higher degree of harmonisation across the Union. A harmonised regulatory framework at Union rather than at Member State level reduces costs for suppliers, ensures a level playing field and ensures the free movement of goods across the internal market. In accordance with the principle of proportionality, as set out in Article 5 TEU, this Regulation does not go beyond what is necessary in order to achieve that objective. (41) Regulation (EC) No 1222/2009 should therefore be repealed with effect from the date of the application of this Regulation, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes a framework for the provision of harmonised information on tyre parameters through labelling to allow end-users to make an informed choice when purchasing tyres, for the purpose of increasing safety, the protection of health, and the economic and environmental efficiency of road transport, by promoting fuel‐efficient, long‐lasting and safe tyres with low noise levels. Article 2 Scope 1. This Regulation applies to C1 tyres, C2 tyres and C3 tyres that are placed on the market. Requirements for re‐treaded tyres apply once a suitable testing method to measure the performance of such tyres is available in accordance with Article 13. 2. This Regulation does not apply to: (a) off‐road professional tyres; (b) tyres designed to be fitted only on vehicles registered for the first time before 1 October 1990; (c) T‐type temporary‐use spare tyres; (d) tyres whose speed rating is less than 80 km/h; (e) tyres whose nominal rim diameter does not exceed 254 mm or is 635 mm or more; (f) tyres fitted with additional devices to improve traction properties, such as studded tyres; (g) tyres designed only to be fitted on vehicles intended exclusively for racing; (h) second‐hand tyres, unless such tyres are imported from a third country. Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘C1 tyres’, ‘C2 tyres’ and ‘C3 tyres’ means tyres belonging to the respective classes set out in Article 8(1) of Regulation (EC) No 661/2009; (2) ‘re‐treaded tyre’ means a used tyre that is reconditioned by replacing the worn tread with new material; (3) ‘T‐type temporary‐use spare tyre’ means a temporary‐use spare tyre designed for use at inflation pressures higher than those established for standard and reinforced tyres; (4) ‘off‐road professional tyre’ means a special‐use tyre used primarily in severe off‐road conditions; (5) ‘tyre label’ means a graphic diagram, in printed or electronic form, including in the form of a sticker, which includes symbols in order to inform end-users about the performance of a tyre or batch of tyres in relation to the parameters set out in Annex I; (6) ‘point of sale’ means a location where tyres are displayed or stored and are offered for sale, including car show rooms where tyres that are not fitted on vehicles are offered for sale to end-users; (7) ‘technical promotional material’ means documentation, in printed or electronic form, that is produced by a supplier to supplement advertising material with the information set out in Annex IV; (8) ‘product information sheet’ means a standard document containing the information set out in Annex III in printed or electronic form; (9) ‘technical documentation’ means documentation sufficient to enable market surveillance authorities to assess the accuracy of the tyre label and the product information sheet, including the information set out in point (2) of Annex VII; (10) ‘product database’ means the product database established pursuant to Article 12 of Regulation (EU) 2017/1369; (11) ‘distance selling’ means the offer for sale, hire or hire purchase by mail order, catalogue, internet, telemarketing or by any other method by which the potential end-user cannot be expected to see the tyre displayed; (12) ‘manufacturer’ means a manufacturer as defined in point (8) of Article 3 of Regulation (EU) 2019/1020; (13) ‘importer’ means an importer as defined in point (9) of Article 3 of Regulation (EU) 2019/1020; (14) ‘authorised representative’ means a natural or legal person established within the Union who has received a written mandate from a manufacturer to act on the manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under the requirements of this Regulation; (15) ‘supplier’ means a manufacturer established in the Union, an authorised representative of a manufacturer who is not established in the Union, or an importer, who places a product on the Union market; (16) ‘distributor’ means a natural or legal person in the supply chain, other than the supplier, who makes a product available on the market; (17) ‘making available on the market’ means making available on the market as defined in point (1) of Article 3 of Regulation (EU) 2019/1020; (18) ‘placing on the market’ means placing on the market as defined in point (2) of Article 3 of Regulation (EU) 2019/1020; (19) ‘end-user’ means a consumer, fleet manager or road transport undertaking that buys or is expected to buy a tyre; (20) ‘parameter’ means a tyre characteristic that has a significant impact on the environment, road safety or health during the use of the tyre, such as tyre abrasion, mileage, rolling resistance, wet grip, external rolling noise, snow grip or ice grip; (21) ‘tyre type’ means a version of a tyre for which the technical characteristics on the tyre label, the product information sheet and the tyre type identifier are the same for all units of that version; (22) ‘verification tolerance’ means the maximum admissible deviation between the measurement and calculation results of the verification tests performed by, or on behalf of, market surveillance authorities, and the values of the declared or published parameters, reflecting deviation arising from interlaboratory variation; (23) ‘tyre type identifier’ means a code, usually alphanumeric, which distinguishes a specific tyre type from other tyre types that have the same trade name or the same trademark as that of the supplier; (24) ‘equivalent tyre type’ means a tyre type which is placed on the market by the same supplier as another tyre type with a different tyre type identifier and which has the same technical characteristics that are relevant to the tyre label and the same product information sheet. Article 4 Obligations of tyre suppliers 1. Suppliers shall ensure that C1 tyres, C2 tyres and C3 tyres that are placed on the market are accompanied free of charge: (a) for each individual tyre, by a tyre label, in the form of a sticker, that complies with the requirements set out in Annex II, indicating the information and class for each of the parameters set out in Annex I, and by a product information sheet; or (b) for each batch of one or more identical tyres, by a printed tyre label that complies with the requirements set out in Annex II, indicating the information and class for each of the parameters set out in Annex I, and by a product information sheet. 2. For tyres sold or offered for sale by distance selling, suppliers shall ensure that the tyre label is displayed close to the price indication and that the product information sheet can be accessed, including, upon request from the end-user, in printed form. The size of the tyre label shall be such that it is clearly visible and legible and shall be proportionate to the size specified in point 2.1 of Annex II. For tyres sold or offered for sale on the internet, suppliers may make the tyre label for a specific tyre type available in a nested display. 3. Suppliers shall ensure that any visual advertisement for a specific tyre type shows the tyre label. If the visual advertisement indicates the price of that tyre type, the tyre label shall be displayed close to the price indication. For visual advertisements on the internet, suppliers may make the tyre label available in a nested display. 4. Suppliers shall ensure that any technical promotional material concerning a specific tyre type displays the tyre label of that tyre type and includes the information set out in Annex IV. 5. Suppliers shall provide to a relevant national authority as defined in point (37) of Article 3 of Regulation (EU) 2018/858 the values used to determine the related classes and any additional performance information that the supplier declares on the tyre label of tyre types in accordance with Annex I to this Regulation, as well as the tyre label that complies with the requirements set out in Annex II to this Regulation. That information shall be submitted to the relevant national authority on the basis of Article 5(1) and (2) of this Regulation before the placing on the market of the tyre types in question, so that the authority may verify the accuracy of the tyre label. 6. Suppliers shall ensure the accuracy of the tyre labels and product information sheets that they provide. 7. Suppliers may make technical documentation available to the authorities of Member States other than those authorities indicated in paragraph 5 or to relevant national accredited bodies on request. 8. Suppliers shall cooperate with market surveillance authorities and shall take immediate action to remedy any case of non‐compliance with this Regulation for which they are responsible, at their own initiative or when required to do so by market surveillance authorities. 9. Suppliers shall not provide or display other labels, marks, symbols or inscriptions that do not comply with this Regulation and that would be likely to mislead or confuse end-users with respect to the parameters set out in Annex I. 10. Suppliers shall not provide or display labels that mimic the tyre label provided for under this Regulation. Article 5 Obligations of tyre suppliers in relation to the product database 1. From 1 May 2021, suppliers shall enter the information set out in Annex VII into the product database before placing on the market a tyre produced after that date. 2. For tyres that are produced between 25 June 2020 and 30 April 2021, the supplier shall enter the information set out in Annex VII into the product database by 30 November 2021. 3. For tyres that are placed on the market before 25 June 2020, the supplier may enter the information set out in Annex VII into the product database. 4. Until the information referred to in paragraphs 1 and 2 has been entered into the product database, the supplier shall make an electronic version of the technical documentation available for inspection within 10 working days of receiving a request from a market surveillance authority. 5. Where type‐approval authorities or market surveillance authorities need information other than that set out in Annex VII in order to carry out their tasks under this Regulation, the supplier shall provide them with that information on request. 6. A tyre for which changes are made that are relevant for the tyre label or the product information sheet shall be considered to be a new tyre type. The supplier shall indicate in the product database when it has ceased to place on the market units of a certain tyre type. 7. After the final unit of a tyre type has been placed on the market, the supplier shall keep the information concerning that tyre type in the compliance part of the product database for a period of five years. Article 6 Obligations of tyre distributors 1. Distributors shall ensure that: (a) at the point of sale, tyres bear a tyre label, in the form of a sticker, that complies with the requirements set out in Annex II, provided by the supplier in accordance with point (a) of Article 4(1) in a clearly visible position and legible in its entirety, and that the product information sheet is available, including, upon request, in printed form; or (b) before the sale of a tyre that is part of a batch of one or more identical tyres, a printed tyre label that complies with the requirements set out in Annex II, is shown to the end-user and is clearly displayed close to the tyre at the point of sale, and that the product information sheet is available. 2. Distributors shall ensure that any visual advertisement for a specific tyre type shows the tyre label. If the visual advertisement indicates the price of that tyre type, the tyre label shall be displayed close to the price indication. For visual advertisements on the internet for a specific tyre type, distributors may make the tyre label available in a nested display. 3. Distributors shall ensure that any technical promotional material concerning a specific tyre type displays the tyre label and includes the information set out in Annex IV. 4. Distributors shall ensure that where tyres offered for sale are not visible to the end-user at the time of sale, they provide the end-user with a copy of the tyre label before the sale. 5. Distributors shall ensure that any paper‐based distance selling shows the tyre label and that end-users can access the product information sheet through a free access website, and can request a printed copy of the product information sheet. 6. Distributors that use telemarketing‐based distance selling shall inform end-users of the classes for each of the parameters on the tyre label, and inform end-users that they can access the tyre label and the product information sheet through a free access website, and by requesting a printed copy. 7. For tyres sold or offered for sale on the internet, distributors shall ensure that the tyre label is displayed close to the price indication and that the product information sheet can be accessed. The size of the tyre label shall be such that it is clearly visible and legible and shall be proportionate to the size specified in point 2.1 of Annex II. Distributors may make the tyre label for a specific tyre type available in a nested display. Article 7 Obligations of vehicle suppliers and vehicle distributors Where end-users intend to acquire a new vehicle, vehicle suppliers and vehicle distributors shall provide, before the sale, those end-users with the tyre label for the tyres offered with or fitted on the vehicle and any relevant technical promotional material, and shall ensure that the product information sheet is available. Article 8 Obligations of hosting service providers Where a service provider as referred to in Article 14 of Directive 2000/31/EC allows the selling of tyres through its internet site, that service provider shall enable the display of the tyre label and the product information sheet provided by the supplier close to the price indication and shall inform the distributor of the obligation to display the tyre label and the product information sheet. Article 9 Testing and measurement methods The information to be provided under Articles 4, 6 and 7 on the parameters indicated on the tyre label shall be obtained in accordance with the testing methods referred to in Annex I and the laboratory alignment procedure referred to in Annex V. Article 10 Verification procedure For each of the parameters set out in Annex I, Member States shall apply the verification procedure set out in Annex VI when assessing the conformity of the declared classes with this Regulation. Article 11 Obligations of Member States 1. Member States shall not impede the placing on the market or putting into service of tyres within their territories, where such tyres comply with this Regulation. 2. Where Member States provide incentives with regard to tyres, such incentives shall target only tyres in class A or B with respect to rolling resistance or wet grip within the meaning of Parts A and B of Annex I, respectively. Taxation and fiscal measures shall not constitute incentives for the purposes of this Regulation. 3. Without prejudice to Regulation (EU) 2019/1020, where the relevant national authority as defined in point (37) of Article 3 of Regulation (EU) 2018/858 has sufficient reason to believe that a supplier has not ensured the accuracy of the tyre label in accordance with Article 4(6) of this Regulation, it shall verify that the classes and any additional performance information declared on the tyre label correspond to the values and to the documentation submitted by the supplier, in accordance with Article 4(5) of this Regulation. 4. In accordance with Regulation (EU) 2019/1020, Member States shall ensure that the national market surveillance authorities establish a system of routine and ad hoc inspections of points of sale for the purposes of ensuring compliance with this Regulation. 5. Member States shall lay down the rules on penalties and enforcement mechanisms applicable to infringements of this Regulation and of the delegated acts adopted pursuant thereto, and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 1 May 2021, notify the Commission of those rules and of those measures that have not previously been notified to the Commission, and shall notify it, without delay, of any subsequent amendment affecting them. Article 12 Union market surveillance and control of products entering the Union market 1. Regulation (EU) 2019/1020 shall apply to the tyres covered by this Regulation and the relevant delegated acts adopted pursuant thereto. 2. The Commission shall encourage and support cooperation and the exchange of information on market surveillance relating to the labelling of tyres between the authorities of the Member States that are responsible for market surveillance or are in charge of the control of tyres entering the Union market, and between those authorities and the Commission, in particular by involving the Administrative Cooperation Group for the Labelling of Tyres more closely. 3. Member States’ national market surveillance strategies established pursuant to Article 13 of Regulation (EU) 2019/1020 shall include actions to ensure the effective enforcement of this Regulation. 4. Market surveillance authorities may recover the costs of document inspection and physical product testing from the supplier in cases of non‐compliance by the supplier with this Regulation or the relevant delegated acts adopted pursuant thereto. Article 13 Delegated acts 1. The Commission is empowered to adopt delegated acts in accordance with Article 14 in order to amend: (a) Annex II with regard to the content and format of the tyre label; (b) parts D and E of Annex I and Annexes II, III, IV, V, VI and VII, by adapting the values, calculation methods and requirements set out therein to technological progress. 2. By 26 June 2022, the Commission shall adopt delegated acts in accordance with Article 14 in order to supplement this Regulation by introducing new information requirements for re‐treaded tyres in the Annexes, provided that a suitable testing method is available. 3. The Commission is also empowered to adopt delegated acts in accordance with Article 14 in order to include parameters or information requirements for tyre abrasion and mileage, as soon as reliable, accurate and reproducible methods to test and measure tyre abrasion and mileage are available for use by European or international standardisation organisations and provided that the following conditions are met: (a) a thorough impact assessment has been carried out by the Commission; and (b) a proper consultation of the relevant stakeholders has been conducted by the Commission. 4. Where appropriate, when preparing delegated acts, the Commission shall test the content and format of tyre labels with representative groups of Union customers to ensure that the tyre labels are clearly understandable, and shall publish the results. Article 14 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 13 shall be conferred on the Commission for a period of five years from 25 June 2020. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five‐year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 13 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law‐Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 13 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 15 Evaluation and report By 1 June 2025, the Commission shall carry out an evaluation of this Regulation and submit a report to the European Parliament, the Council and the European Economic and Social Committee. That report shall assess how effectively this Regulation and the delegated acts adopted pursuant thereto have led end-users to choose higher‐performing tyres, taking into account the impact of this Regulation and the delegated acts adopted pursuant thereto on business, fuel consumption, safety, greenhouse gas emissions, consumer awareness and market surveillance activities. The report shall also assess the costs and benefits of mandatory independent third‐party verification of the information provided in the tyre label, taking into account experience gained with regard to the broader framework provided by Regulation (EC) No 661/2009. Article 16 Amendment to Regulation (EU) 2017/1369 In Article 12(2) of Regulation (EU) 2017/1369, point (a) is replaced by the following: ‘(a) to support market surveillance authorities in carrying out their tasks under this Regulation and the relevant delegated acts, including enforcement thereof, and under Regulation (EU) 2020/740 of the European Parliament and of the Council (*1). Article 17 Repeal of Regulation (EC) No 1222/2009 Regulation (EC) No 1222/2009 is repealed with effect from 1 May 2021. References to the repealed Regulation shall be construed as references to this Regulation and read in accordance with the correlation table in Annex VIII to this Regulation. Article 18 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 May 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 25 May 2020. For the European Parliament The President D. M. SASSOLI For the Council The President A. METELKO-ZGOMBIĆ (1) OJ C 62, 15.2.2019, p. 280. (2) Position of the European Parliament of 26 March 2019 (not yet published in the Official Journal) and position of the Council at first reading of 25 February 2020 (OJ C 105, 31.3.2020, p. 1). Position of the European Parliament of 13 May 2020 (not yet published in the Official Journal). (3) Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46). (4) Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, p. 1). (5) Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise (OJ L 189, 18.7.2002, p. 12). (6) Regulation No 117 of the Economic Commission for Europe of the United Nations (UNECE) – Uniform provisions concerning the approval of tyres with regard to rolling sound emissions and/or to adhesion on wet surfaces and/or to rolling resistance [2016/1350] (OJ L 218, 12.8.2016, p. 1). (7) Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1). (8) Regulation (EU) 2018/956 of the European Parliament and of the Council of 28 June 2018 on the monitoring and reporting of CO2 emissions from and fuel consumption of new heavy-duty vehicles (OJ L 173, 9.7.2018, p. 1). (9) Regulation (EU) 2019/1242 of the European Parliament and of the Council of 20 June 2019 setting CO2 emission performance standards for new heavy-duty vehicles and amending Regulations (EC) No 595/2009 and (EU) 2018/956 of the European Parliament and of the Council and Council Directive 96/53/EC (OJ L 198, 25.7.2019, p. 202). (10) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1). (11) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1). (12) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1). (13) OJ L 123, 12.5.2016, p. 1. ANNEX I TESTING, GRADING AND MEASUREMENT OF TYRE PARAMETERS Part A: Fuel efficiency classes and rolling resistance coefficient The fuel efficiency class shall be determined and illustrated on the tyre label on the basis of the rolling resistance coefficient (RRC in N/kN) according to the ‘A’ to ‘E’ scale specified in the table below and measured in accordance with Annex 6 to UNECE Regulation No 117 and aligned in accordance with the laboratory alignment procedure set out in Annex V. If a tyre type belongs to more than one tyre class (e.g. C1 and C2), the grading scale used to determine the fuel efficiency class of that tyre type shall be that which is applicable to the highest tyre class (e.g. C2, not C1). C1 tyres C2 tyres C3 tyres Fuel efficiency class RRC in N/kN RRC in N/kN RRC in N/kN A RRC ≤ 6,5 RRC ≤ 5,5 RRC ≤ 4,0 B 6,6 ≤ RRC ≤ 7,7 5,6 ≤ RRC ≤ 6,7 4,1 ≤ RRC ≤ 5,0 C 7,8 ≤ RRC ≤ 9,0 6,8 ≤ RRC ≤ 8,0 5,1 ≤ RRC ≤ 6,0 D 9,1 ≤ RRC ≤ 10,5 8,1 ≤ RRC ≤ 9,0 6,1 ≤ RRC ≤ 7,0 E RRC ≥ 10,6 RRC ≥ 9,1 RRC ≥ 7,1 Part B: Wet grip classes 1. The wet grip class shall be determined and illustrated on the tyre label on the basis of the wet grip index (G) according to the ‘A’ to ‘E’ scale specified in the table below, calculated in accordance with point 2 and measured in accordance with Annex 5 to UNECE Regulation No 117. 2. Calculation of wet grip index (G) G = G(T)–0,03 where: G(T) = wet grip index of the candidate tyre as measured in one test cycle C1 tyres C2 tyres C3 tyres Wet grip class G G G A 1,55 ≤ G 1,40 ≤ G 1,25 ≤ G B 1,40 ≤ G ≤ 1,54 1,25 ≤ G ≤ 1,39 1,10 ≤ G ≤ 1,24 C 1,25 ≤ G ≤ 1,39 1,10 ≤ G ≤ 1,24 0,95 ≤ G ≤ 1,09 D 1,10 ≤ G ≤ 1,24 0,95 ≤ G ≤ 1,09 0,80 ≤ G ≤ 0,94 E G ≤ 1,09 G ≤ 0,94 G ≤ 0,79 Part C: External rolling noise classes and measured value The external rolling noise measured value (N, in dB(A)) shall be declared in decibels and calculated in accordance with Annex 3 to UNECE Regulation No 117. The external rolling noise class shall be determined and illustrated on the tyre label on the basis of the limit values (LV) set out in Part C of Annex II to Regulation (EC) No 661/2009 as follows: N ≤ LV – 3 LV – 3 < N ≤ LV N > LV Part D: Snow grip The snow grip performance shall be tested in accordance with Annex 7 to UNECE Regulation No 117. A tyre which satisfies the minimum snow grip index values set out in UNECE Regulation No 117 shall be classified as a tyre for use in severe snow conditions and the following pictogram shall be included on the tyre label. Part E: Ice grip The ice grip performance shall be tested in accordance with reliable, accurate and reproducible methods, including, where appropriate, international standards, which take into account the generally recognised state of the art. The tyre label of a tyre which satisfies the relevant minimum ice grip index values shall include the following pictogram. ANNEX II CONTENT AND FORMAT OF THE TYRE LABEL 1. Content of the tyre label 1.1. Information to be included in the upper part of the tyre label: 1.2. Information to be included in the bottom part of the tyre label for all tyres other than tyres which satisfy the minimum snow grip index values set out in UNECE Regulation No 117, or the relevant minimum ice grip index values, or both: 1.3. Information to be included in the bottom part of the tyre label for tyres which satisfy the minimum snow grip index values set out in UNECE Regulation No 117: 1.4. Information to be included in the bottom part of the tyre label for tyres which satisfy the relevant minimum ice grip index values: 1.5. Information to be included in the bottom part of the tyre label for tyres which satisfy both the relevant minimum snow grip index values set out in UNECE Regulation No 117 and the minimum ice grip index values: 2. Format of the tyre label 2.1. Format of the upper part of the tyre label: 2.1.1. Format of the bottom part of the tyre label for all tyres other than tyres which satisfy the minimum snow grip index values set out in UNECE Regulation No 117, or the relevant minimum ice grip index values, or both: 2.1.2. Format of the bottom part of the tyre label for tyres which satisfy the minimum snow grip index values set out in UNECE Regulation No 117: 2.1.3. Format of the bottom part of the tyre label for tyres which satisfy the minimum ice grip index values: 2.1.4. Format of the bottom part of the tyre label for tyres which satisfy both the relevant minimum snow grip index values set out in UNECE Regulation No 117 and the minimum ice grip index values: 2.2. For the purposes of point 2.1: (a) Tyre label minimal size: 75 mm wide and 110 mm high. Where the tyre label is printed in a larger format, its content shall nevertheless remain proportionate to the specifications above; (b) Background of the tyre label: 100 % white; (c) Typefaces: Verdana and Calibri; (d) Dimensions and specifications of the elements constituting the tyre label: as specified above; (e) Colour codes, using CMYK – cyan, magenta, yellow and black, shall fulfil all the following requirements: — colours of the EU logo as follows: — background: 100,80,0,0; — stars: 0,0,100,0; — colour of the energy logo: 100,80,0,0; — QR code: 100 % black; — trade name or trademark of the supplier: 100 % black and in Verdana Bold 7 pt; — tyre type identifier: 100 % black and in Verdana Regular 7 pt; — tyre size designation, load‐capacity index and speed category symbol: 100 % black and in Verdana Regular 10 pt; — tyre class: 100 % black and in Verdana Regular 7 pt, aligned to the right; — letters of the fuel efficiency scale and of the wet grip scale: 100 % white and in Calibri Bold 19 pt; the letters shall be centred on an axis at 4,5 mm from the left side of the arrows; — CMYK colour codes of arrows for the A to E fuel efficiency scale as follows: — A‐class: 100,0,100,0; — B‐class: 45,0,100,0; — C‐class: 0,0,100,0; — D‐class: 0,30,100,0; — E‐class: 0,100,100,0; — CMYK colour codes of arrows for the A to E wet grip scale as follows: — A: 100,60,0,0; — B: 90,40,0,0; — C: 65,20,0,0; — D: 50,10,0,0; — E: 30,0,0,0; — internal dividers: weight of 0,5 pts, colour shall be 100 % black; — letter of the fuel efficiency class: 100 % white and in Calibri Bold 33 pt. Fuel efficiency and wet grip class arrows and the corresponding arrows in the A to E scale shall be positioned in such a way that their tips are aligned. The letter in the fuel efficiency class and in the wet grip class arrow shall be positioned in the centre of the rectangular part of the arrow which shall be 100 % black; — fuel efficiency pictogram: width 16 mm, height 14 mm, weight 1 pts, colour: 100 % black; — wet grip pictogram: width 20 mm, height 14 mm, weight 1 pts, colour: 100 % black; — external rolling noise pictogram: width 24 mm, height 18 mm, weight 1 pts, colour: 100 % black. Number of decibels in the loudspeaker in Verdana Bold 12 pt, the unit ‘dB’ in Regular 9 pt; the range of external rolling noise classes (A to C) centred under the pictogram, with the letter of the applicable external rolling noise class in Verdana Bold 16 pt and the other letters of the external rolling noise classes in Verdana Regular 10 pt; — snow grip pictogram: width 15 mm, height 13 mm, weight 1 pts, colour: 100 % black; — ice grip pictogram: width 15 mm, height 13 mm, weight 1 pts, weight of oblique bars 0,5 pts, colour: 100 % black; — the number of the regulation shall be 100 % black and in Verdana Regular 6 pt. (1) Regulation No 30 of the Economic Commission for Europe of the United Nations (UN/ECE) – Uniform provisions concerning the approval of pneumatic tyres for motor vehicles and their trailers (OJ L 201, 30.7.2008, p. 70). (2) Regulation No 54 of the Economic Commission for Europe of the United Nations (UNECE) – Uniform provisions concerning the approval of pneumatic tyres for commercial vehicles and their trailers (OJ L 183, 11.7.2008, p. 41). ANNEX III PRODUCT INFORMATION SHEET The information in the product information sheet of tyres shall be included in the product brochure or other literature provided with the tyre and shall include the following: (a) the trade name or trademark of the supplier or of the manufacturer if it is not the same as that of the supplier; (b) the tyre type identifier; (c) the tyre size designation, load‐capacity index and speed category symbol, as indicated in UNECE Regulation No 30 or in UNECE Regulation No 54 for C1 tyres, C2 tyres and C3 tyres, as applicable; (d) the fuel efficiency class of the tyre in accordance with Annex I; (e) the wet grip class of the tyre in accordance with Annex I; (f) the external rolling noise class and value in decibels in accordance with Annex I; (g) an indication of whether the tyre is a tyre for use in severe snow conditions; (h) an indication of whether the tyre is an ice grip tyre; (i) the date of start of production of the tyre type (two digits for the week and two digits for the year); (j) the date of end of production of the tyre type, once known (two digits for the week and two digits for the year). ANNEX IV INFORMATION PROVIDED IN TECHNICAL PROMOTIONAL MATERIAL 1. Information on tyres included in technical promotional material shall be provided in the following order: (a) the fuel efficiency class (letter ‘A’ to ‘E’); (b) the wet grip class (letter ‘A’ to ‘E’); (c) the external rolling noise class and measured value in dB; (d) an indication of whether the tyre is a tyre for use in severe snow conditions; (e) an indication of whether the tyre is an ice grip tyre. 2. The information referred to in point 1 shall meet the following requirements: (a) it shall be easy to read; (b) it shall be easy to understand; (c) if within a tyre family tyre types are classified differently depending on dimension or other characteristics, the range between the lowest performing and highest performing tyre types shall be stated. 3. Suppliers shall also make the following available on their websites: (a) a link to the relevant Commission webpage dedicated to this Regulation; (b) an explanation of the pictograms printed on the tyre label; (c) a statement highlighting the fact that actual fuel savings and road safety depend heavily on the behaviour of drivers, and in particular on the following: — eco‐driving can significantly reduce fuel consumption; — tyre pressure needs to be regularly checked to optimise fuel efficiency and wet grip; — stopping distances must always be respected. 4. Suppliers and distributors shall also, where relevant, make available on their websites a statement highlighting the fact that ice grip tyres are specifically designed for road surfaces covered with ice and compact snow, and should only be used in very severe climate conditions (e.g. cold temperatures) and that using ice grip tyres in less severe climate conditions (e.g. wet conditions or warmer temperatures) could result in sub‐optimal performance, in particular for wet grip, handling and wear. ANNEX V LABORATORY ALIGNMENT PROCEDURE FOR THE MEASUREMENT OF ROLLING RESISTANCE 1. Definitions For the purposes of the laboratory alignment procedure for the measurement of rolling resistance, the following definitions apply: (1) ‘reference laboratory’ means a laboratory that is part of the network of laboratories, the names of which have been published in the Official Journal of the European Union for the purpose of the laboratory alignment procedure, and that is able to achieve the accuracy of test results determined in Section 3 with its reference machine; (2) ‘candidate laboratory’ means a laboratory participating in the laboratory alignment procedure that is not a reference laboratory; (3) ‘alignment tyre’ means a tyre that is tested for the purpose of performing the laboratory alignment procedure; (4) ‘alignment tyre set’ means a set of five or more alignment tyres for the alignment of one single machine; (5) ‘assigned value’ means a theoretical value of the rolling resistance coefficient (RRC) of one alignment tyre as measured by a theoretical laboratory which is representative of the network of reference laboratories that is used for the laboratory alignment procedure; (6) ‘machine’ means every tyre testing spindle in one specific measurement method; for example, two spindles acting on the same drum shall not be considered as one machine. 2. General provisions 2.1. Principle The measured (m) rolling resistance coefficient obtained in a reference laboratory (l), (RRCm,l ), shall be aligned to the assigned values of the network of reference laboratories. The measured (m) rolling resistance coefficient obtained by a machine in a candidate laboratory (c), (RRCm,c ), shall be aligned through one reference laboratory of the network of its choice. 2.2. Tyre selection requirements Alignment tyre sets shall be selected for the laboratory alignment procedure in accordance with the following criteria. One alignment tyre set shall be selected for C1 tyres and C2 tyres together, and one set for C3 tyres: (a) the alignment tyre set shall be selected so as to cover the range of different RRCs of C1 tyres and C2 tyres together, or of C3 tyres; in any event, the difference between the highest RRCm of the alignment tyre set, and the lowest RRCm of the alignment tyre set shall be, before and after alignment, at least equal to: (i) 3 N/kN for C1 tyres and C2 tyres; and (ii) 2 N/kN for C3 tyres; (b) the RRCm in the candidate or reference laboratories (RRCm,c or RRCm,l ) based on declared RRC values of each alignment tyre of the alignment tyre set shall be distributed evenly; (c) load index values shall adequately cover the range of the tyres to be tested, ensuring that the rolling resistance values also cover the range of the tyres to be tested. Each alignment tyre shall be checked prior to use and shall be replaced when: (a) the alignment tyre shows a condition which makes it unusable for further tests; or (b) there are deviations of RRCm,c or RRCm,l greater than 1,5 % relative to earlier measurements after correction for any machine drift. 2.3. Measurement method The reference laboratory shall measure each alignment tyre four times and retain the three last results for further analysis, in accordance with paragraph 4 of Annex 6 to UNECE Regulation No 117 and under the conditions set out in paragraph 3 of Annex 6 to UNECE Regulation No 117. The candidate laboratory shall measure each alignment tyre (n + 1) times, with n being specified in Section 5 of this Annex and retain the n last results for further analysis, in accordance with paragraph 4 of Annex 6 to UNECE Regulation No 117 and applying the conditions set out in paragraph 3 of Annex 6 to UNECE Regulation No 117. Each time an alignment tyre is measured, the tyre/wheel assembly shall be removed from the machine and the entire test procedure referred to in paragraph 4 of Annex 6 to UNECE Regulation No 117 shall be followed again from the start. The candidate or reference laboratory shall calculate: (a) the measured value of each alignment tyre for each measurement as specified in paragraphs 6.2 and 6.3 of Annex 6 to UNECE Regulation No 117 (i.e. corrected for a temperature of 25 °C and a drum diameter of 2 m); (b) the mean value of the three last measured values of each alignment tyre (in the case of reference laboratories) or the mean value of the n last measured values of each alignment tyre (in the case of candidate laboratories); and (c) the standard deviation (σm ) as follows: where: i is the counter from 1 to p for the alignment tyres; j is the counter from 2 to n + 1 for the n last repetitions of each measurement of a given alignment tyre; n + 1 is the number of repetitions of tyre measurements (n + 1 = 4 for reference laboratories and n + 1 ≥ 4 for candidate laboratories); p is the number of alignment tyres (p ≥ 5). 2.4. Data formats to be used for the computations and results The measured RRC values corrected from drum diameter and temperature shall be rounded to two decimal places. Then the computations shall be made with all digits: there shall be no further rounding except on the final alignment equations. All standard deviation values shall be displayed to three decimal places. All RRC values will be displayed to two decimal places. All alignment coefficients (A1 l , B1 l , A2 c and B2 c ) shall be rounded and displayed to four decimal places. 3. Requirements applicable to the reference laboratories and determination of the assigned values The assigned values of each alignment tyre shall be determined by a network of reference laboratories. Every second year the network shall assess the stability and validity of the assigned values. Each reference laboratory participating in the network shall comply with the specifications of Annex 6 to UNECE Regulation No 117 and have a standard deviation (σm ) as follows: (a) not greater than 0,05 N/kN for C1 tyres and C2 tyres; and (b) not greater than 0,05 N/kN for C3 tyres. The alignment tyre sets that have been selected in accordance with Section 2.2 shall be measured in accordance with Section 2.3 by each reference laboratory of the network. The assigned value of each alignment tyre is the average of the measured values given by the reference laboratories of the network for this alignment tyre. 4. Procedure for the alignment of a reference laboratory to the assigned values Each reference laboratory (l) shall align itself to each new set of assigned values and always after any significant machine change or any drift in machine control tyre monitoring data. The alignment shall use a linear regression technique on all individual data. The regression coefficients, A1 l and B1 l , shall be calculated as follows: RRC = A1 l × RRCm,l + B1 l where: RRC l is the assigned value of the rolling resistance coefficient; RRCm, l is the individual measured value of the rolling resistance coefficient by the reference laboratory ‘l’ (including temperature and drum diameter corrections). 5. Requirements applicable to candidate laboratories Candidate laboratories shall repeat the alignment procedure at least once every second year for every machine and always after any significant machine change or any drift in machine control tyre monitoring data. A common set of five different tyres that have been selected in accordance with Section 2.2 shall be measured in accordance with Section 2.3 first by the candidate laboratory and then by one reference laboratory. More than five alignment tyres may be tested at the request of the candidate laboratory. The candidate laboratory shall provide the alignment tyre set to the selected reference laboratory. The candidate laboratory (c) shall comply with the specifications of Annex 6 to UNECE Regulation No 117 and preferably have standard deviations (σm ) as follows: (a) not greater than 0,075 N/kN for C1 tyres and C2 tyres; and (b) not greater than 0,06 N/kN for C3 tyres. If the standard deviation (σm ) of the candidate laboratory is higher than those values after four measurements, the last three being used for the computations, then the number n + 1 of measurement repetitions shall be increased as follows for the entire batch: n + 1 = 1 + (σm /γ)2, rounded up to the nearest higher integer value where: γ = 0,043 N/kN for C1 tyres and C2 tyres; γ = 0,035 N/kN for C3 tyres. 6. Procedure for the alignment of a candidate laboratory One reference laboratory (l) of the network shall calculate the linear regression function on all individual data of the candidate laboratory (c). The regression coefficients, A2 c and B2 c , shall be calculated as follows: RRCm,l = A2 c × RRCm,c + B2 c where: RRCm,l is the individual measured value of the rolling resistance coefficient by the reference laboratory (l) (including temperature and drum diameter corrections); RRCm,c is the individual measured value of the rolling resistance coefficient by the candidate laboratory (c) (including temperature and drum diameter corrections) If the coefficient of determination R2 is lower than 0,97, the candidate laboratory shall not be aligned. The aligned RRC of tyres tested by the candidate laboratory shall be calculated as follows: RRC = (A1 l × A2 c ) × RRCm,c + (A1 l × B2 c + B1 l ) ANNEX VI VERIFICATION PROCEDURE The conformity with this Regulation of the declared fuel efficiency, wet grip and external rolling noise classes, as well as the declared values, and any additional performance information on the tyre label, shall be assessed for each tyre type or each grouping of tyres as determined by the supplier, according to one of the following procedures: 1. A single tyre or tyre set is tested first. If the measured values meet the declared classes or the declared external rolling noise value within the verification tolerances referred to in the table below, the tyre label shall be considered to comply with this Regulation. If the measured values do not meet the declared classes or the declared external rolling noise value within the verification tolerances referred to in the table below, three additional tyres or tyre sets are to be tested; the average measurement value stemming from the three additional tyres or tyre sets tested is to be used to verify the declared information, taking into account the verification tolerances referred to in the table below. 2. Where the classes or values on the tyre label are derived from type‐approval test results obtained in accordance with Regulation (EC) No 661/2009, or UNECE Regulation No 117, Member States may use measurement data obtained from the conformity of production tests on tyres that were carried out under the type‐approval procedure established by Regulation (EU) 2018/858. Assessments of the measurement data obtained from the conformity of production tests shall take into account the verification tolerances referred to in the table below. Measured parameter Verification tolerances RRC (fuel efficiency) The aligned measured value shall not be greater than the upper limit (the highest RRC) of the declared class by more than 0,3 N/kN. External rolling noise The measured value shall not be greater than the declared value of N by more than 1 dB(A). Wet grip The measured value G(T) shall not be lower than the lower limit (the lowest value of G) of the declared class. Snow grip The measured value shall not be lower than the minimum snow grip index. Ice grip The measured value shall not be lower than the minimum ice grip index. ANNEX VII INFORMATION TO BE ENTERED INTO THE PRODUCT DATABASE BY THE SUPPLIER 1. Information to be entered into the public part of the product database: (a) the trade name or trademark, address, contact details and other legal identification of the supplier; (b) the tyre type identifier; (c) the tyre label in electronic format; (d) the class(es) and other parameters of the tyre label; and (e) the parameters of the product information sheet in electronic format. 2. Information to be entered into the compliance part of the product database: (a) the tyre type identifier of all equivalent tyre types that are already placed on the market; (b) a general description of the tyre type, including its dimensions, load index and speed rating, sufficient for it to be unequivocally and easily identified; (c) protocols of the testing, grading and measurement of the tyre parameters set out in Annex I; (d) specific precautions, if any, that shall be taken when the tyre type is assembled, installed, maintained or tested; (e) the measured technical parameters of the tyre type, where relevant; and (f) the calculations performed with the measured technical parameters. ANNEX VIII CORRELATION TABLE Regulation (EC) No 1222/2009 This Regulation Article 1(1) — Article 1(2) Article 1 Article 2(1) Article 2(1) Article 2(2) Article 2(2) Article 3, point (1) Article 3, point (1) — Article 3, point (2) Article 3, point (2) Article 3, point (3) — Article 3, point (4) — Article 3, point (5) Article 3, point (3) Article 3, point (6) Article 3, point (4) Article 3, point (7) — Article 3, point (8) Article 3, point (5) Article 3, point (9) — Article 3, point (10) — Article 3, point (11) Article 3, point (6) Article 3, point (12) Article 3, point (7) Article 3, point (13) Article 3, point (8) Article 3, point (14) Article 3, point (9) Article 3, point (15) Article 3, point (10) Article 3, point (16) Article 3, point (11) Article 3, point (17) — Article 3, point (18) Article 3, point (12) Article 3, point (19) Article 3, point (13) Article 3, point (20) — Article 3, point (21) — Article 3, point (22) — Article 3, point (23) — Article 3, point (24) Article 4 Article 4 Article 4(1) Article 4(1) Article 4(1), point (a) Article 4(1), point (a) Article 4(1), point (b) Article 4(1), point (b) Article 4(2) — — Article 4(2) — Article 4(3) Article 4(3) Article 4(4) Article 4(4) Article 4(5) — Article 4(6) — Article 4(7) — Article 4(8) — Article 4(9) — Article 4(10) — Article 5 Article 5(1) Article 6(1) Article 5(1), point (a) Article 6(1), point (a) Article 5(1), point (b) Article 6(1), point (b) — Article 6(2) — Article 6(3) Article 5(2) Article 6(4) Article 5(3) — — Article 6(5) — Article 6(6) — Article 6(7) Article 6 Article 7 — Article 8 Article 7 Article 9 Article 8 Article 10 Article 9(1) Article 11(1) Article 9(2) Article 11(1) Article 9(2), 2nd sentence Article 4(5) Article 10 Article 11(2) — Article 11(3) Article 11, point (a) — Article 11, point (b) — Article 11, point (c) Article 13(1), point (b) Article 12 Article 11(4) — Article 11(5) — Article 12 — Article 13 — Article 13(1) — Article 13(2) — Article 13(3) — Article 13(4) — Article 14 Article 13 — Article 14 — — Article 15 Article 15 — — Article 16 — Article 17 Article 16 Article 18 Annex I Annex I Annex II Annex II — Annex III Annex III Annex IV Annex IV Annex VI Annex IVa Annex V Annex V — — Annex VII — Annex VIII

Information on tyre fuel efficiency, braking capacity and noise levels Information on tyre fuel efficiency, braking capacity and noise levels SUMMARY OF: Regulation (EU) 2020/740 on the labelling of tyres with respect to fuel efficiency and other parameters WHAT IS THE AIM OF THE REGULATION? It aims to give consumers more information when choosing new tyres for their vehicles. It makes labels about a tyre’s characteristics and performance, in snow and ice for instance, more visible and informative. This will help end-users* take into account features such as safety, health protection and economic and environmental efficiency. The legislation is designed to promote fuel-efficient, long-lasting and safe tyres with low noise levels. It amends Regulation (EU) 2017/1369 (see summary). KEY POINTS The regulation: applies to tyres for passenger cars (C1 tyres), buses and coaches, light and heavy goods vehicles, and light and heavy trailers (C2 and C3 tyres), as well as to retreads* once a suitable performance test is available; does not apply to certain specalised categories of tyre, such as those for off-road professional use, to vehicles first registered before 1 October 1990 or to second-hand tyres, unless imported from a non-EU country. Tyre suppliers must: attach a sticker label to individual tyres and a printed label to a batch of tyres, containing the information set out in Annexes I and II, and provide a product information sheet containing the details specified in Annex III; make the tyre label visible, preferably close to the price, in advertisements and distance selling or internet sales; ensure the tyre labels and product information sheets are accurate; cooperate with market surveillance authorities, which may carry out routine and ad hoc inspections, and act immediately if any infringements are discovered; provide their national authorities, via a product database, with technical details of the tyres and their performance before they are offered for sale, enabling authorities to check the accuracy of the tyre labels — the information will have to be supplied from 1 May 2021 (and by 30 November 2021 for tyres produced between 25 June 2020 and 30 April 2021); not provide or display labels, marks, symbols or inscriptions that do not comply with the regulation. Tyre distributors must: attach a sticker label to individual tyres and a printed label to a batch of tyres at the point of sale, containing the information required; ensure the tyre label is displayed close to the price on any technical promotional material, paper-based distances sales, and advertisements and internet sales; provide customers with a copy of the tyre label before a sale, if the tyres are not visible; inform customers where they can access the product information sheet. Suppliers and distributors of new vehicles must provide customers with the tyre label, product information sheet and any relevant technical promotional material before a purchase is made. Internet service providers must ensure that suppliers selling tyres on their sites display the necessary label as well as the information sheet. National authorities must: allow the sale and use of tyres that comply with the legislation; verify the accuracy of the information on the tyre labels; lay down penalty and enforcement rules for any infringements. The European Commission: encourages and supports cooperation and information exchange between market surveillance authorities; may adopt delegated acts to amend some of the annexes to take account of technical improvements; submits a report evaluating the regulation to the European Parliament, the Council and the European Economic and Social Committee by 1 June 2025. Repeal Regulation (EU) 2020/740 repeals the tyre-labelling Regulation (EC) No 1222/2009 (see summary). FROM WHEN DOES THE REGULATION APPLY? It applies from 1 May 2021. BACKGROUND The tyre-labelling system aims to reduce greenhouse gas emissions and noise pollution and improve road safety. Tyres account for 20-30% of a vehicle’s fuel consumption. Reducing their rolling resistance helps cut emissions and increase savings for drivers through lower fuel consumption. For more information, see: Tyres — Energy label (European Commission). KEY TERMS End-user: an individual consumer, fleet manager or road transport company. Retread: a reconditioned tyre where the worn tread is replaced with new material. MAIN DOCUMENT Regulation (EU) 2020/740 of the European Parliament and of the Council of 25 May 2020 on the labelling of tyres with respect to fuel efficiency and other parameters, amending Regulation (EU) 2017/1369 and repealing Regulation (EC) No 1222/2009 (OJ L 177, 5.6.2020, pp. 1-31) Successive amendments to Regulation (EU) 2020/740 have been incorporated into the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, pp. 1-44) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, pp. 1-218) Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, pp. 1-23) Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, pp. 46-58) See consolidated version. Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, pp. 1-24) See consolidated version. last update 02.12.2020

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20.5.2014 EN Official Journal of the European Union L 150/168 REGULATION (EU) No 516/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 establishing the Asylum, Migration and Integration Fund, amending Council Decision 2008/381/EC and repealing Decisions No 573/2007/EC and No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION Having regard to the Treaty on the Functioning of the European Union, and in particular Article 78(2) and Article 79(2) and (4) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The Union’s objective to constitute an area of freedom, security and justice should be achieved, inter alia, through common measures framing a policy on asylum and immigration, based on solidarity between Member States, which is fair towards third countries and their nationals. The European Council of 2 December 2009 recognised that financial resources within the Union should be made increasingly flexible and coherent, in terms of both scope and applicability, to support policy developments in the field of asylum and migration. (2) In order to contribute to the development of the common Union policy on asylum and immigration and to the strengthening of the area of freedom, security and justice in the light of the application of the principles of solidarity and responsibility-sharing between the Member States and cooperation with third countries, this Regulation should establish the Asylum, Migration and Integration Fund (‘the Fund’). (3) The Fund should reflect the need for increased flexibility and simplification, while respecting requirements in terms of predictability, and ensuring a fair and transparent distribution of resources to meet the general and specific objectives laid down in this Regulation. (4) Efficiency of measures and quality of spending constitute guiding principles in the implementation of the Fund. Furthermore, the Fund should also be implemented in the most effective and user-friendly manner possible. (5) The new two-pillar structure of funding in the field of home affairs should contribute to the simplification, rationalisation, consolidation and transparency of funding in that field. Synergies, consistency and complementarity should be sought between different funds and programmes, including with a view to allocating funding to common objectives. However, any overlap between the different funding instruments should be avoided. (6) The Fund should create a flexible framework allowing Member States to receive financial resources under their national programmes to support the policy areas under the Fund according to their specific situation and needs, and in the light of the general and specific objectives of the Fund, for which the financial support would be the most effective and appropriate. (7) The Fund should express solidarity through financial assistance to Member States. It should enhance the effective management of migration flows to the Union in areas where the Union adds maximum value, in particular by sharing responsibility between Member States and by sharing responsibility and strengthening cooperation with third countries. (8) In order to contribute to the achievement of the general objective of the Fund, Member States should ensure that their national programmes include actions addressing the specific objectives of this Regulation, and that the allocation of resources between objectives ensures that the objectives can be met. In the unusual event that a Member State wishes to derogate from the minimum percentages laid down in this Regulation, the Member State concerned should provide a detailed justification within its national programme. (9) To ensure a uniform and high-quality asylum policy and apply higher standards of international protection, the Fund should contribute to the effective functioning of the Common European Asylum System, which encompasses measures relating to policy, legislation, and capacity-building, while acting in cooperation with other Member States, Union agencies and third countries. (10) It is appropriate to support and improve the efforts made by Member States to fully and properly implement the Union asylum acquis, in particular to grant appropriate reception conditions to displaced persons and applicants for, and beneficiaries of, international protection, to ensure the correct determination of status, in accordance with Directive 2011/95/EU of the European Parliament and of the Council (4), to apply fair and effective asylum procedures and to promote good practice in the field of asylum, so as to protect the rights of persons requiring international protection and enable Member States’ asylum systems to work efficiently. (11) The Fund should offer adequate support to joint efforts by Member States to identify, share and promote best practices and establish effective cooperation structures in order to enhance the quality of decision-making in the framework of the Common European Asylum System. (12) The Fund should complement and reinforce the activities undertaken by the European Asylum Support Office (‘EASO’) established by Regulation (EU) No 439/2010 of the European Parliament and of the Council (5), with a view to coordinating practical cooperation between Member States on asylum, supporting Member States subject to particular pressure on their asylum systems and contributing to the implementation of the Common European Asylum System. The Commission may make use of the possibility offered by Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (6) to entrust EASO with the implementation of specific, ad hoc tasks, such as the coordination of Member States’ actions on resettlement in accordance with Regulation (EU) No 439/2010. (13) The Fund should support the efforts by the Union and the Member States relating to the enhancement of the Member States’ capacity to develop, monitor and evaluate their asylum policies in the light of their obligations under existing Union law. (14) The Fund should support the efforts made by Member States to provide international protection and a durable solution in their territories to refugees and displaced persons identified as eligible for resettlement by the United Nations High Commissioner for Refugees (‘UNHCR’), such as the assessment of the resettlement needs and transfer of the persons concerned to their territories, with a view to granting them a secure legal status and to promoting their effective integration. (15) The Fund should provide support for new approaches concerning access to asylum procedures in a safer manner, in particular by targeting main countries of transit such as protection programmes for particular groups or certain procedures for examination of applications for asylum. (16) It is in the nature of the Fund that it should be able to provide support to voluntary burden-sharing operations agreed between Member States and consisting of the transfer of beneficiaries of international protection, and of applicants for international protection, from one Member State to another. (17) Partnerships and cooperation with third countries to ensure the adequate management of inflows of persons applying for asylum or other forms of international protection are an essential component of Union asylum policy. With the aim of providing access to international protection and durable solutions at the earliest possible stage, including in the framework of Regional Protection Programmes, the Fund should include a strong Union resettlement component. (18) To improve and reinforce the integration process in European societies, the Fund should facilitate legal migration to the Union in accordance with the economic and social needs of Member States and anticipate the preparation of the integration process already in the country of origin of the third-country nationals coming to the Union. (19) In order to be efficient and achieve the greatest added value, the Fund should pursue a more targeted approach, in support of consistent strategies specifically designed to promote the integration of third-country nationals at national, local and/or regional level, where appropriate. Those strategies should be implemented mainly by local or regional authorities and non-state actors, while not excluding national authorities, in particular where the specific administrative organisation of a Member State would so require, or where, in a Member State, integration actions fall within a competence shared between the State and decentralised administration. The implementing organisations should choose the measures most appropriate to their particular situation from a range of measures available. (20) The implementation of the Fund should be consistent with the Union’s Common Basic Principles on Integration, as specified in the Common Programme for Integration. (21) The scope of the integration measures should also include beneficiaries of international protection in order to ensure a comprehensive approach to integration, taking into account the specificities of those target groups. Where integration measures are combined with reception measures, actions should, where appropriate, also allow applicants for international protection to be included. (22) To ensure the consistency of the Union’s response to the integration of third-country nationals, actions financed under the Fund should be specific and complementary to actions financed under the European Social Fund. In this context, the authorities of the Member States responsible for the implementation of the Fund should be required to establish cooperation and coordination mechanisms with the authorities designated by Member States for the purpose of the management of the interventions of the European Social Fund. (23) For practical reasons, some actions may concern a group of people which can be more efficiently addressed as a whole, without distinguishing between its members. It would therefore be appropriate to provide for the possibility for those Member States that would so wish to provide in their national programmes that integration actions may include immediate relatives of third-country nationals, to the extent that it is necessary for the effective implementation of such actions. The term ‘immediate relative’ would be understood as meaning spouses, partners, and any person having direct family links in descending or ascending line with the third-country national targeted by the integration action, and who would otherwise not be covered by the scope of the Fund. (24) The Fund should support Member States in setting up strategies organising legal migration, enhancing their capacity to develop, implement, monitor and evaluate in general all immigration and integration strategies, policies and measures for third-country nationals, including Union legal instruments. The Fund should also support the exchange of information, best practices and cooperation between different departments of administration as well as with other Member States. (25) The Union should continue and expand the use of Mobility Partnerships as the main strategic, comprehensive and long-term cooperation framework for migration management with third countries. The Fund should support activities in the framework of Mobility Partnerships taking place either in the Union or in third countries and aimed at pursuing Union needs and priorities, in particular actions ensuring the continuity of funding encompassing both the Union and third countries. (26) It is appropriate to continue supporting and encouraging efforts by the Member States to improve the management of the return of third-country nationals in all its dimensions, with a view to the continuous, fair and effective implementation of common standards on return, in particular as set out in Directive 2008/115/EC of the European Parliament and of the Council (7). The Fund should promote the development of return strategies at national level within the concept of integrated return management, and also measures supporting their effective implementation in third countries. (27) As regards the voluntary return of persons, including persons who wish to be returned even though they are under no obligation to leave the territory, incentives for such returnees, such as preferential treatment in the form of enhanced return assistance, should be envisaged. This kind of voluntary return is in the interests of both returnees and the authorities in terms of its cost-effectiveness. Member States should be encouraged to give preference to voluntary return. (28) However, from a policy point of view, voluntary and enforced return are interlinked and have a mutually reinforcing effect, and Member States should therefore be encouraged in their return management to reinforce the complementarities of the two forms. There is a need to carry out removals in order to safeguard the integrity of the immigration and asylum policy of the Union and the immigration and asylum systems of the Member States. Thus, the possibility of removals is a prerequisite for ensuring that this policy is not undermined and for enforcing the rule of law, which itself is essential to the creation of an area of freedom, security and justice. The Fund should therefore support actions of Member States to facilitate removals in accordance with the standards laid down in Union law, where applicable, and with full respect for the fundamental rights and dignity of returnees. (29) It is essential for the Fund to support specific measures for returnees in the country of return, in order to ensure their effective return to their town or region of origin under good conditions and to enhance their durable reintegration into their community. (30) Union readmission agreements are an integral component of the Union return policy and a central tool for the efficient management of migration flows, as they facilitate the swift return of irregular migrants. Those agreements are an important element in the framework of the dialogue and cooperation with third countries of origin and transit of irregular migrants, and their implementation in third countries should be supported in the interests of effective return strategies at national and Union level. (31) The Fund should complement and reinforce the activities undertaken by the European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union, established by Council Regulation (EC) No 2007/2004 (8), part of the tasks of which are to provide Member States with the necessary support for organising joint return operations and identifying best practices on the acquisition of travel documents and the removal of illegally staying third-country nationals in the territories of the Member States, as well as to assist Member States in circumstances requiring increased technical and operational assistance at the external borders, taking into account that some situations may involve humanitarian emergencies and rescue at sea. (32) In addition to supporting the return of persons as provided for in this Regulation, the Fund should also support other measures to combat illegal immigration or the circumventing of existing legal migration rules, thereby safeguarding the integrity of Member States’ immigration systems. (33) The Fund should be implemented in full respect for the rights and principles enshrined in the Charter of Fundamental Rights of the European Union and for the fundamental rights enshrined in the relevant international instruments, including the relevant case-law of the European Court of Human Rights. Eligible actions should take account of the human rights-based approach to the protection of migrants, refugees and asylum seekers and should, in particular, ensure that special attention is paid to, and a dedicated response is provided for, the specific situation of vulnerable persons, in particular women, unaccompanied minors and other minors at risk. (34) The terms ‘vulnerable persons’ and ‘family members’ are defined differently in different acts relevant for this Regulation. They should therefore be understood in the meaning of the relevant act, bearing in mind the context in which they are used. In the context of resettlement, Member States that resettle should closely consult the UNHCR in relation to the term ‘family members’ in their resettlement practices and actual resettlement processes. (35) Measures on and in relation to third countries supported through the Fund should be adopted in synergy and in coherence with other actions outside the Union supported through Union external assistance instruments, both geographic and thematic. In particular, in implementing such actions, full coherence should be sought with the principles and general objectives of Union’s external action and foreign policy related to the country or region in question. The measures should not be intended to support actions that are directly oriented towards development and should complement, when appropriate, the financial assistance provided through external aid instruments. The principle of policy coherence for development, as set out in paragraph 35 of the European Consensus on Development, should be respected. It is also important to ensure that the implementation of emergency assistance is consistent with and, where relevant, complementary to the Union’s humanitarian policy and respects humanitarian principles as set out in the European Consensus on Humanitarian Aid. (36) A large part of the available resources under the Fund should be allocated proportionately to the responsibility borne by each Member State through its efforts in managing migration flows on the basis of objective criteria. For that purpose, the latest available statistical data collected by Eurostat under Regulation (EC) No 862/2007 of the European Parliament and of the Council (9) relating to the migration flows, such as the number of first asylum applications, the number of positive decisions granting refugee or subsidiary protection status, the number of resettled refugees, the number of legally residing third-country nationals, the number of third-country nationals who have obtained an authorisation issued by a Member State to reside, the number of return decisions issued by national authorities and the number of effected returns, should be used. (37) The allocation of basic amounts to Member States is laid down by this Regulation. The basic amount is composed of a minimum amount and an amount calculated on the basis of the average of 2011, 2012 and 2013 allocations for each Member State under the European Refugee Fund, established by Decision No 573/2007/EC of the European Parliament and of the Council (10), the European Fund for the Integration of third-country nationals established by Council Decision 2007/435/EC (11) and the European Return Fund established by Decision No 575/2007/EC of the European Parliament and of the Council (12). The calculation of allocations was made in accordance with the distribution criteria laid down in Decision No 573/2007/EC, Decision 2007/435/EC and Decision No 575/2007/EC. In the light of the European Council conclusions of 7-8 February 2013, which underlined that particular emphasis should be given to insular societies who face disproportional migration challenges, it is appropriate to increase the minimum amounts for Cyprus and Malta. (38) Whilst it is appropriate for an amount to be allocated to each Member State on the basis of the latest available statistical data, part of the available resources under the Fund should also be distributed for the implementation of specific actions which require cooperative effort amongst Member States and generate significant added value for the Union, as well as for the implementation of a Union Resettlement Programme and the transfer of beneficiaries of international protection from one Member State to another. (39) For that purpose, this Regulation should establish a list of specific actions eligible for resources from the Fund. Additional amounts should be allocated to those Member States which make a commitment to implement such actions. (40) In the light of the progressive establishment of a Union Resettlement Programme, the Fund should provide targeted assistance in the form of financial incentives (lump sums) for each resettled person. The Commission, in cooperation with the EASO and in accordance with their respective competences, should monitor the effective implementation of resettlement operations supported under the Fund. (41) With a view to increasing the impact of the Union’s resettlement efforts in providing protection to persons in need of international protection and maximising the strategic impact of resettlement through a better targeting of those persons who are in greatest need of resettlement, common priorities with respect to resettlement should be formulated at Union level. Those common priorities should be amended only where there is a clear justification for doing so, or in the light of any recommendations from the UNHCR, on the basis of the general categories specified in this Regulation. (42) Given their particular vulnerability, some categories of persons in need of international protection should always be included in the common Union resettlement priorities. (43) Taking into account the resettlement needs set out in the common Union resettlement priorities, it is also necessary that additional financial incentives are provided for the resettlement of persons with respect to specific geographic regions and nationalities, as well as to the specific categories of persons to be resettled, where resettlement is determined to be the most appropriate response to their special needs. (44) To enhance the solidarity and better share the responsibility between the Member States, in particular towards those most affected by asylum flows, a similar mechanism based on financial incentives should also be established for the transfer of beneficiaries of international protection from one Member State to another. Such a mechanism should reduce the pressure on Member States receiving higher numbers of asylum seekers and beneficiaries of international protection, either in absolute or proportionate terms. (45) The support provided by the Fund will be more efficient and bring greater added value if a limited number of compulsory objectives are identified in this Regulation, to be pursued in the programmes drawn up by each Member State and taking into account its specific situation and needs. (46) It is important for enhanced solidarity that the Fund provides, in coordination and in synergy with the humanitarian assistance managed by the Commission where appropriate, additional support to address emergency situations of heavy migratory pressure in Member States or third countries, or in the event of mass influx of displaced persons, pursuant to Council Directive 2001/55/EC (13), through emergency assistance. Emergency assistance should also include support to ad hoc humanitarian admission programmes aimed at allowing temporary stay on the territory of a Member State in the event of an urgent humanitarian crisis in third countries. However, such other humanitarian admission programmes are without prejudice to, and should not undermine, the Union’s resettlement programme that explicitly aims as from the start to provide a durable solution to persons in need of international protection transferred to the Union from third countries. To that end, Member States should not be entitled to receive additional lump sums in respect of persons granted temporary stay on the territory of a Member State under such other humanitarian admission programmes. (47) This Regulation should provide financial assistance for the activities of the European Migration Network established by Council Decision 2008/381/EC (14), in accordance with its objectives and tasks. (48) Decision 2008/381/EC should therefore be amended to align procedures and to facilitate the provision of appropriate and timely financial support to the National Contact Points that are referred to in that Decision. (49) In the light of the purpose of financial incentives allocated to the Member States for resettlement and/or the transfer of beneficiaries of international protection from one Member State to another in the form of lump sums, and because they represent a small fraction of the actual costs, this Regulation should provide for certain derogations from the rules on the eligibility of expenditure. (50) In order to supplement or amend provisions of this Regulation on lump sums for resettlement and transfer of beneficiaries of international protection from one Member State to another and on the definition of specific actions and of common Union resettlement priorities, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (51) In the application of this Regulation, including the preparation of delegated acts, the Commission should consult experts from all Member States. (52) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (15). (53) Funding from the Union budget should concentrate on activities where the Union intervention can bring additional value compared to the action of Member States alone. As the Union is in a better position than Member States to provide a framework for expressing Union solidarity in the management of migration flows, financial support provided under this Regulation should contribute, in particular, to strengthening national and Union capabilities in this area. (54) There is a need to maximise the impact of Union funding by mobilising, pooling and leveraging public and private financial resources. (55) The Commission should monitor the implementation of the Fund in accordance with Regulation (EU) No 514/2014 of the European Parliament and of the Council (16), with the aid of common indicators for evaluating results and impacts. Those indicators, including relevant baselines, should provide the minimum basis for evaluating the extent to which the objectives of the Fund have been achieved. (56) In order to measure the achievements of the Fund, common indicators should be established in relation to each of its specific objectives. The common indicators should not affect the optional or mandatory nature of the implementation of related actions as laid down in this Regulation. (57) For the purpose of its management and implementation, the Fund should form part of a coherent framework consisting of this Regulation and Regulation (EU) No 513/2014 of the European Parliament and of the Council (17). For the purposes of the Fund, the partnership provided for in Regulation (EU) No 514/2014 should include relevant international organisations, non-governmental organisations and social partners. Each Member State should be responsible for establishing the composition of the partnership and the practical arrangements concerning its implementation. (58) Since the objective of this Regulation, namely contributing to the efficient management of migration flows and to the implementation, strengthening and development of the common policy on asylum, subsidiary protection and temporary protection and the common immigration policy, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (59) Pursuant to Articles 8 and 10 TFEU, the Fund should take account of the mainstreaming of equality between women and men and anti-discrimination principles. (60) Decisions No 573/2007/EC, No 575/2007/EC and 2007/435/EC should be repealed, subject to the transitional provisions set out in this Regulation. (61) In accordance with Article 3 of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, those Member States have notified their wish to take part in the adoption and application of this Regulation. (62) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (63) It is appropriate to align the period of application of this Regulation with that of Council Regulation (EU, Euratom) No 1311/2013 (18). Therefore, this Regulation should apply as from 1 January 2014, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Purpose and scope 1. This Regulation establishes the Asylum, Migration and Integration Fund (‘the Fund’) for the period from 1 January 2014 to 31 December 2020. 2. This Regulation lays down: (a) the objectives of financial support and the eligible actions; (b) the general framework for the implementation of eligible actions; (c) the available financial resources and their distribution; (d) the principles and mechanism for the establishment of common Union resettlement priorities; and (e) the financial assistance provided for the activities of the European Migration Network. 3. This Regulation provides for the application of the rules set out in Regulation (EU) No 514/2014, without prejudice to Article 4 of this Regulation. Article 2 Definitions For the purpose of this Regulation, the following definitions apply: (a) ‘resettlement’ means the process whereby, on a request from the United Nations High Commissioner for Refugees (‘UNHCR’) based on a person’s need for international protection, third-country nationals are transferred from a third country and established in a Member State where they are permitted to reside with one of the following statuses: (i) ‘refugee status’ within the meaning of point (e) of Article 2 of Directive 2011/95/EU; (ii) ‘subsidiary protection status’ within the meaning of point (g) of Article 2 of Directive 2011/95/EU; or (iii) any other status which offers similar rights and benefits under national and Union law as those referred to in points (i) and (ii); (b) ‘other humanitarian admission programmes’ means an ad hoc process whereby a Member State admits a number of third-country nationals to stay on its territory for a temporary period of time in order to protect them from urgent humanitarian crises due to events such as political developments or conflicts; (c) ‘international protection’ means refugee status and subsidiary protection status within the meaning of Directive 2011/95/EU; (d) ‘return’ means the process of a third-country national going back, whether in voluntary compliance with an obligation to return or enforced, as defined in Article 3 of Directive 2008/115/EC; (e) ‘third-country national’ means any person who is not a citizen of the Union within the meaning of Article 20(1) TFEU. Reference to third-country nationals shall be understood to include stateless persons and persons with undetermined nationality; (f) ‘removal’ means the enforcement of the obligation to return, namely the physical transportation out of the Member State, as defined in Article 3 of Directive 2008/115/EC; (g) ‘voluntary departure’ means compliance with the obligation to return within the time-limit fixed for that purpose in the return decision, as defined in Article 3 of Directive 2008/115/EC; (h) ‘unaccompanied minor’ means a third-country national below the age of 18 years, who arrives or arrived on the territory of a Member State unaccompanied by an adult responsible for him/her whether by law or the national practice of the Member State concerned, and for as long as he/she is not effectively taken into the care of such a person; it includes a minor who is left unaccompanied after he/she entered the territory of a Member State; (i) ‘vulnerable person’ means any third-country national who complies with the definition under Union law relevant to the policy area of action supported under the Fund; (j) ‘family member’ means any third-country national who complies with the definition under Union law relevant to the policy area of action supported under the Fund; (k) ‘emergency situation’ means a situation resulting from: (i) heavy migratory pressure in one or more Member States characterised by a large and disproportionate inflow of third-country nationals, which places significant and urgent demands on their reception and detention facilities, asylum systems and procedures; (ii) the implementation of temporary protection mechanisms within the meaning of Directive 2001/55/EC; or (iii) heavy migratory pressure in third countries where refugees are stranded due to events such as political developments or conflicts. Article 3 Objectives 1. The general objective of the Fund shall be to contribute to the efficient management of migration flows and to the implementation, strengthening and development of the common policy on asylum, subsidiary protection and temporary protection and the common immigration policy, while fully respecting the rights and principles enshrined in the Charter of Fundamental Rights of the European Union. 2. Within its general objective, the Fund shall contribute to the following common specific objectives: (a) to strengthen and develop all aspects of the Common European Asylum System, including its external dimension; (b) to support legal migration to the Member States in accordance with their economic and social needs, such as labour market needs, while safeguarding the integrity of the immigration systems of Member States, and to promote the effective integration of third-country nationals; (c) to enhance fair and effective return strategies in the Member States which contribute to combating illegal immigration, with an emphasis on sustainability of return and effective readmission in the countries of origin and transit; (d) to enhance solidarity and responsibility-sharing between the Member States, in particular towards those most affected by migration and asylum flows, including through practical cooperation. The achievement of the specific objectives of the Fund shall be evaluated in accordance with Article 55(2) of Regulation (EU) No 514/2014 using common indicators as set out in Annex IV to this Regulation and programme-specific indicators included in national programmes. 3. Measures taken to achieve the objectives referred to in paragraphs 1 and 2 shall be fully coherent with measures supported through the external financing instruments of the Union and with the principles and general objectives of the Union’s external action. 4. The objectives referred to in paragraphs 1 and 2 of this Article shall be achieved with due regard to the principles and objectives of the Union’s humanitarian policy. Consistency with the measures funded by the Union’s external financing instruments shall be ensured in accordance with Article 24. Article 4 Partnership For the purposes of the Fund, the partnership referred to in Article 12 of Regulation (EU) No 514/2014 shall include relevant international organisations, non-governmental organisations and social partners. CHAPTER II COMMON EUROPEAN ASYLUM SYSTEM Article 5 Reception and asylum systems 1. Within the specific objective laid down in point (a) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes laid down in Article 19 of this Regulation, the Fund shall support actions focusing on one or more of the following categories of third-country nationals: (a) those who enjoy refugee status or subsidiary protection status within the meaning of Directive 2011/95/EU; (b) those who have applied for one of the forms of international protection referred to in point (a) and have not yet received a final decision; (c) those who enjoy temporary protection within the meaning of Directive 2001/55/EC; (d) those who are being or have been resettled in or transferred from a Member State. As regards reception conditions and asylum procedures, the Fund shall support, in particular, the following actions focusing on the categories of persons referred to in the first subparagraph of this paragraph: (a) the provision of material aid, including assistance at the border, education, training, support services, health and psychological care; (b) the provision of support services such as translation and interpretation, education, training, including language training, and other initiatives which are consistent with the status of the person concerned; (c) the setting-up and improvement of administrative structures, systems and training for staff and relevant authorities to ensure effective and easy access to asylum procedures for asylum seekers and efficient and high-quality asylum procedures, in particular, where necessary, to support the development of the Union acquis; (d) the provision of social assistance, information or help with administrative and/or judicial formalities and information or counselling on the possible outcomes of the asylum procedure, including on aspects such as return procedures; (e) the provision of legal assistance and representation; (f) the identification of vulnerable groups and specific assistance for vulnerable persons, in particular in accordance with points (a) to (e); (g) the establishment, development and improvement of alternative measures to detention. Where deemed appropriate, and where the national programme of a Member State provides for them, the Fund may also support integration-related measures, such as those referred to in Article 9(1), concerning the reception of persons referred to in the first subparagraph of this paragraph. 2. Within the specific objective defined in point (a) of the first subparagraph of Article 3(2), and in line with the objectives of the national programmes defined in Article 19, as regards accommodation infrastructure and reception systems, the Fund shall support, in particular, the following actions: (a) the improvement and maintenance of existing accommodation infrastructure and services; (b) the strengthening and improvement of administrative structures and systems; (c) information for local communities; (d) the training of the staff of authorities, including local authorities, who will be interacting with the persons referred to in paragraph 1 in the context of their reception; (e) the establishment, running and development of new accommodation infrastructure and services, as well as administrative structures and systems, in particular, where necessary, to address the structural needs of Member States. 3. Within the specific objectives laid down in points (a) and (d) of the first subparagraph of Article 3(2), and in accordance with the objectives of the national programmes defined in Article 19, the Fund shall also support actions similar to those listed in paragraph 1 of this Article, where such actions are related to persons who are temporarily staying: — in transit and processing centres for refugees, in particular to support resettlement operations in cooperation with the UNHCR, or — on the territory of a Member State in the context of other humanitarian admission programmes. Article 6 Member States’ capacity to develop, monitor and evaluate their asylum policies and procedures Within the specific objective laid down in point (a) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, as regards actions relating to the enhancement of Member States’ capacity to develop, monitor and evaluate their asylum policies and procedures, the Fund shall support, in particular, the following actions: (a) actions enhancing the capacity of Member States — including in relation to the mechanism for early warning, preparedness and crisis management established in Regulation (EU) No 604/2013 of the European Parliament and of the Council (19) — to collect, analyse and disseminate qualitative and quantitative data and statistics on asylum procedures, reception capacities, resettlement and the transfer of applicants for and/or beneficiaries of international protection from one Member State to another; (b) actions enhancing the capacity of Member States to collect, analyse and disseminate country-of-origin information; (c) actions directly contributing to the evaluation of asylum policies, such as national impact assessments, surveys amongst target groups and other relevant stakeholders, and to the development of indicators and benchmarking. Article 7 Resettlement, transfer of applicants for, and beneficiaries of, international protection and other ad hoc humanitarian admission 1. Within the specific objective laid down in points (a) and (d) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, the Fund shall support, in particular, the following actions related to resettlement of any third country national who is being resettled or has been resettled in a Member State, and other humanitarian admission programmes: (a) the establishment and development of national resettlement programmes and strategies and other humanitarian admission programmes, including needs analysis, improvement of indicators and evaluation; (b) the establishment of appropriate infrastructure and services to ensure the smooth and effective implementation of resettlement actions and actions concerning other humanitarian admission programmes, including language assistance; (c) the setting up of structures, systems and training of staff to conduct missions to the third countries and/or other Member States, to carry out interviews and to conduct medical and security screening; (d) the assessment of potential resettlement cases and/or cases of other humanitarian admission by the competent Member States’ authorities, such as conducting missions to the third country, carrying out interviews and conducting medical and security screening; (e) pre-departure health assessment and medical treatment, pre-departure material provisions, pre-departure information and integration measures and travel arrangements, including the provision of medical escort services; (f) information and assistance upon arrival or shortly thereafter, including interpretation services; (g) actions for family reunification purposes for persons being resettled in a Member State; (h) the strengthening of infrastructure and services relevant to migration and asylum in the countries designated for the implementation of Regional Protection Programmes; (i) creating conditions conducive to the integration, autonomy and self-reliance of resettled refugees on a long-term basis. 2. Within the specific objective laid down in point (d) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of the Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, the Fund shall also support actions similar to those listed in paragraph 1 of this Article, where deemed appropriate in the light of policy developments within the implementation period of the Fund or where the national programme of a Member State makes such provisions, in relation to the transfer of applicants for and/or beneficiaries of international protection. Such operations shall be carried out with their consent from the Member State which granted them international protection or is responsible for examining their application to another interested Member State where they will be granted equivalent protection or where their application for international protection will be examined. CHAPTER III INTEGRATION OF THIRD-COUNTRY NATIONALS AND LEGAL MIGRATION Article 8 Immigration and pre-departure measures Within the specific objective laid down in point (b) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, the Fund shall support actions taking place in a third country which focus on third-country nationals who comply with specific pre-departure measures and/or conditions set out in national law and in accordance with Union law where applicable, including those relating to the ability to integrate in the society of a Member State. In this context, the Fund shall support, in particular, the following actions: (a) information packages and campaigns to raise awareness and promote intercultural dialogue, including via user-friendly communication and information technology and websites; (b) the assessment of skills and qualifications, as well as enhancement of transparency and compatibility of skills and qualifications in a third country with those of a Member State; (c) training enhancing employability in a Member State; (d) comprehensive civic orientation courses and language tuition; (e) assistance in the context of applications for family reunification within the meaning of Council Directive 2003/86/EC (20). Article 9 Integration measures 1. Within the specific objective laid down in point (b) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, the Fund shall support actions which take place in the framework of consistent strategies, taking into account the integration needs of third-country nationals at local and/or regional level. In this context, the Fund shall support, in particular, the following actions focusing on third-country nationals who are residing legally in a Member State or, where appropriate, who are in the process of acquiring legal residence in a Member State: (a) setting up and developing such integration strategies with the participation of local or regional actors, where appropriate, including needs analysis, the improvement of integration indicators, and evaluation, including participatory assessments, in order to identify best practices; (b) providing advice and assistance in areas such as housing, means of subsistence, administrative and legal guidance, health, psychological and social care, child care and family reunification; (c) actions introducing third-country nationals to the receiving society and actions enabling them to adapt to it, to inform them about their rights and obligations, to participate in civil and cultural life and to share the values enshrined in the Charter of Fundamental Rights of the European Union; (d) measures focusing on education and training, including language training and preparatory actions to facilitate access to the labour market; (e) actions designed to promote self-empowerment and to enable third-country nationals to provide for themselves; (f) actions that promote meaningful contact and constructive dialogue between third-country nationals and the receiving society, and actions to promote acceptance by the receiving society, including through the involvement of the media; (g) actions promoting both equality of access and equality of outcomes in relation to third-country nationals’ dealings with public and private services, including adaptation of those services to dealing with third-country nationals; (h) capacity-building of beneficiaries, as defined in point (g) of Article 2 of Regulation (EU) No 514/2014, including through exchanges of experience and best practices, and networking. 2. The actions referred to in paragraph 1 shall, wherever necessary, take into account the specific needs of different categories of third-country nationals, including beneficiaries of international protection, resettled or transferred persons and, in particular, vulnerable persons. 3. National programmes may allow for the inclusion in the actions referred to in paragraph 1 of immediate relatives of persons covered by the target group referred to in that paragraph, to the extent that it is necessary for the effective implementation of such actions. 4. For the purpose of programming and implementation of the actions referred to in paragraph 1 of this Article, the partnership referred to in Article 12 of Regulation (EU) No 514/2014 shall include the authorities designated by Member States for the purpose of the management of the interventions of the European Social Fund. Article 10 Practical cooperation and capacity-building measures Within the specific objective laid down in point (b) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of the Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, the Fund shall support actions focusing on one or more of the following: (a) building up strategies promoting legal migration with a view to facilitating the development and implementation of flexible admission procedures; (b) supporting cooperation between third countries and the recruitment agencies, the employment services and the immigration services of Member States, as well as supporting Member States in their implementation of Union migration law, consultation processes with relevant stakeholders and expert advice or information exchanges on approaches which target specific nationalities or categories of third-country nationals with respect to the needs of the labour markets; (c) reinforcing the capacity of Member States to develop, implement, monitor and evaluate their immigration strategies, policies and measures across the different levels and departments of administrations, in particular enhancing their capacity to collect, analyse and disseminate detailed and systematic data and statistics on migration procedures and flows and residence permits, and develop monitoring tools, evaluation schemes, indicators and benchmarking for measuring the achievement of those strategies; (d) training of beneficiaries as defined in point (g) of Article 2 of Regulation (EU) No 514/2014 and of staff providing public and private services, including educational institutions, promoting the exchange of experiences and best practices, cooperation and networking, and intercultural capacities, as well as improving the quality of services provided; (e) building sustainable organisational structures for integration and diversity management, in particular through cooperation between different stakeholders enabling officials at various levels of national administrations to swiftly acquire information about experiences and best practices elsewhere and, where possible, to pool resources between relevant authorities as well as between governmental and non-governmental bodies to provide services to third-country nationals more effectively, inter alia, through one-stop-shops (i.e. coordinated integration-support centres); (f) contributing to a dynamic two-way process of mutual interaction, underlying integration strategies at local and regional level by developing platforms for the consultation of third-country nationals, exchanges of information among stakeholders and intercultural and religious dialogue platforms between third-country nationals’ communities, between those communities and the receiving society and/or between those communities and policy and decision-making authorities; (g) actions to promote and reinforce the practical cooperation between the relevant authorities of Member States, with a focus on, inter alia, exchanges of information, best practices and strategies, and the development and implementation of joint actions, including with a view to safeguarding the integrity of the immigration systems of Member States. CHAPTER IV RETURN Article 11 Measures accompanying return procedures Within the specific objective laid down in point (c) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, as regards measures accompanying return procedures, the Fund shall focus on one or more of the following categories of third-country nationals: (a) third-country nationals who have not yet received a final negative decision in relation to their request to stay, their legal residence and/or international protection in a Member State, and who may choose to make use of voluntary return; (b) third-country nationals enjoying the right to stay, legal residence and/or international protection within the meaning of Directive 2011/95/EU, or temporary protection within the meaning of Directive 2001/55/EC in a Member State, and who have chosen to make use of voluntary return; (c) third-country nationals who are present in a Member State and do not or no longer fulfil the conditions for entry and/or stay in a Member State, including those third-country nationals whose removal has been postponed in accordance with Article 9 and Article 14(1) of Directive 2008/115/EC. In this context, the Fund shall support, in particular, the following actions focusing on the categories of persons referred to in the first subparagraph: (a) the introduction, development and improvement of alternative measures to detention; (b) the provision of social assistance, information or help with administrative and/or judicial formalities and information or counselling; (c) the provision of legal aid and language assistance; (d) specific assistance for vulnerable persons; (e) the introduction and improvement of independent and effective systems for monitoring enforced return, as laid down in Article 8(6) of Directive 2008/115/EC; (f) the establishment, maintenance and improvement of accommodation, reception or detention infrastructure, services and conditions; (g) the setting-up of administrative structures and systems, including IT tools; (h) the training of staff to ensure smooth and effective return procedures, including their management and implementation. Article 12 Return measures Within the specific objective laid down in point (c) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, as regards return measures the Fund shall support actions focusing on the persons referred to in Article 11 of this Regulation. In this context, the Fund shall support, in particular, the following actions: (a) measures necessary for the preparation of return operations, such as those leading to the identification of third-country nationals, to the issuing of travel documents and to family tracing; (b) cooperation with the consular authorities and immigration services of third countries with a view to obtaining travel documents, facilitating repatriation and ensuring readmission; (c) assisted voluntary return measures, including medical examinations and assistance, travel arrangements, financial contributions and pre- and post-return counselling and assistance; (d) removal operations, including related measures, in accordance with the standards laid down in Union law, with the exception of coercive equipment; (e) measures to launch the progress of reintegration for the returnee’s personal development, such as cash-incentives, training, placement and employment assistance and start-up support for economic activities; (f) facilities and services in third countries ensuring appropriate temporary accommodation and reception upon arrival; (g) specific assistance for vulnerable persons. Article 13 Practical cooperation and capacity-building measures Within the specific objective laid down in point (c) of the first subparagraph of Article 3(2) of this Regulation, in the light of the outcome of the policy dialogue as provided for in Article 13 of Regulation (EU) No 514/2014, and in accordance with the objectives of the national programmes defined in Article 19 of this Regulation, as regards practical cooperation and capacity-building measures the Fund shall support, in particular, the following actions: (a) actions to promote, develop and reinforce operational cooperation and information exchange between the return services and other authorities of Member States involved in return, including as regards cooperation with the consular authorities and immigration services of third countries and joint return operations; (b) actions to support cooperation between third countries and the return services of Member States, including measures aiming to strengthen third countries’ capacities to conduct readmission and reintegration activities, in particular in the framework of readmission agreements; (c) actions enhancing the capacity to develop effective and sustainable return policies, in particular by exchanging information on the situation in countries of return, best practices, sharing experiences and pooling resources between Member States; (d) actions enhancing the capacity to collect, analyse and disseminate detailed and systematic data and statistics on return procedures and measures, reception and detention capacities, enforced and voluntary returns, monitoring and reintegration; (e) actions directly contributing to the evaluation of return policies, such as national impact assessments, surveys amongst target groups, the development of indicators and benchmarking; (f) information measures and campaigns in third countries aimed at raising awareness of the appropriate legal channels for immigration and the risks of illegal immigration. CHAPTER V FINANCIAL AND IMPLEMENTATION FRAMEWORK Article 14 Global resources and implementation 1. The global resources for the implementation of this Regulation shall be EUR 3 137 million in current prices. 2. The annual appropriations for the Fund shall be authorised by the European Parliament and the Council within the limits of the multiannual financial framework. 3. The global resources shall be implemented through the following means: (a) national programmes, in accordance with Article 19; (b) Union actions, in accordance with Article 20; (c) emergency assistance, in accordance with Article 21; (d) the European Migration Network, in accordance with Article 22; (e) technical assistance, in accordance with Article 23. 4. The budget allocated under this Regulation to Union actions referred to in Article 20 of this Regulation, to the emergency assistance referred to in Article 21 of this Regulation, to the European Migration Network referred to in Article 22 of this Regulation and to the technical assistance referred to in Article 23 of this Regulation shall be implemented under direct management in accordance with point (a) of Article 58(1) of Regulation (EU, Euratom) No 966/2012 and, where appropriate, under indirect management in accordance with point (c) of Article 58(1) of Regulation (EU, Euratom) No 966/2012. The budget allocated to national programmes referred to in Article 19 of this Regulation shall be implemented under shared management in accordance with point (b) of Article 58(1) of Regulation (EU, Euratom) No 966/2012. 5. The Commission shall remain responsible for the implementation of the Union budget in accordance with Article 317 TFEU and shall inform the European Parliament and the Council of the operations carried out by entities other than Member States. 6. Without prejudice to the prerogatives of the European Parliament and of the Council, the prime reference financial envelope shall be used indicatively as follows: (a) EUR 2 752 million for national programmes of Member States; (b) EUR 385 million for Union actions, emergency assistance, the European Migration Network and technical assistance of the Commission, of which at least 30 % shall be used for Union actions and the European Migration Network. Article 15 Resources for eligible actions in the Member States 1. The amount of EUR 2 752 million shall be allocated to the Member States indicatively as follows: (a) EUR 2 392 million shall be allocated as indicated in Annex I. Member States shall allocate at least 20 % of those resources to the specific objective referred to in point (a) of the first subparagraph of Article 3(2), and at least 20 % to the specific objective referred to in point (b) of the first subparagraph of Article 3(2). Member States may depart from those minimum percentages only where a detailed explanation is included in the national programme as to why allocating resources below this level does not jeopardise the achievement of the objective. As far as the specific objective referred to in point (a) of the first subparagraph of Article 3(2) is concerned, those Member States faced with structural deficiencies in the area of accommodation, infrastructure and services shall not fall below the minimum percentage laid down in this Regulation; (b) EUR 360 million shall be allocated on the basis of the distribution mechanism for specific actions as referred to in Article 16, for the Union Resettlement Programme as referred to Article 17, and for the transfer of beneficiaries of international protection from one Member State to another as referred to in Article 18. 2. The amount referred to in point (b) of paragraph 1 shall support: (a) specific actions listed in Annex II; (b) the Union Resettlement Programme in accordance with Article 17 and/or transfers of beneficiaries of international protection from one Member State to another in accordance with Article 18. 3. In the event that an amount remains available under point (b) of paragraph 1 of this Article or that another amount is available, it will be allocated in the framework of the mid-term review laid down in Article 15 of Regulation (EU) No 514/2014 pro-rata to the basic amounts for national programmes established in Annex I to this Regulation. Article 16 Resources for specific actions 1. An additional amount as referred to in point (a) of Article 15(2) may be allocated to the Member States, provided that it is earmarked as such in the programme and that it is used to implement the specific actions listed in Annex II. 2. To take into account new policy developments, the Commission shall be empowered to adopt delegated acts in accordance with Article 26 of this Regulation to revise Annex II in the context of the mid-term review referred to in Article 15 of Regulation (EU) No 514/2014. On the basis of the revised list of specific actions, Member States may receive an additional amount as laid down in paragraph 1 of this Article, subject to available resources. 3. The additional amounts referred to in paragraphs 1 and 2 of this Article shall be allocated to the Member States in the individual financing decisions approving or revising their national programmes in the context of the mid-term review according to the procedure laid down in Articles 14 and 15 of Regulation (EU) No 514/2014. Those amounts shall only be used for the implementation of the specific actions listed in Annex II to this Regulation. Article 17 Resources for the Union Resettlement Programme 1. Member States shall, in addition to their allocation calculated in accordance with point (a) of Article 15(1), receive every two years an additional amount as set out in point (b) of Article 15(2) based on a lump sum of EUR 6 000 for each resettled person. 2. The lump sum referred to in paragraph 1 shall be increased to EUR 10 000 for each person resettled in accordance with the common Union resettlement priorities established pursuant to paragraph 3 and listed in Annex III and for each vulnerable person as laid down in paragraph 5. 3. The common Union resettlement priorities shall be based on the following general categories of persons: (a) persons from a country or region designated for the implementation of a Regional Protection Programme; (b) persons from a country or region which has been identified in the UNHCR resettlement forecast and where Union common action would have a significant impact on addressing the protection needs; (c) persons belonging to a specific category falling within the UNHCR resettlement criteria. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 26 to amend Annex III, on the basis of the general categories set out in paragraph 3 of this Article, where there is a clear justification for doing so or in the light of any recommendations from the UNHCR. 5. The following vulnerable groups of persons shall also qualify for the lump sum provided for in paragraph 2: (a) women and children at risk; (b) unaccompanied minors; (c) persons having medical needs that can be addressed only through resettlement; (d) persons in need of emergency resettlement or urgent resettlement for legal or physical protection needs, including victims of violence or torture. 6. Where a Member State resettles a person belonging to more than one of the categories referred to in paragraphs 1 and 2, it shall receive the lump sum for that person only once. 7. Where appropriate, Member States may also be eligible for lump sums for family members of persons referred to in paragraphs 1, 3 and 5, provided that those family members have been resettled in accordance with this Regulation. 8. The Commission shall establish, by way of implementing acts, the timetable and other implementation conditions related to the allocation mechanism of resources for the Union Resettlement Programme. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 27(2). 9. The additional amounts referred to in paragraphs 1 and 2 of this Article shall be allocated to the Member States every two years, for the first time in the individual financing decisions approving their national programme in accordance with the procedure laid down in Article 14 of Regulation (EU) No 514/2014, and later in a financing decision to be annexed to the decisions approving their national programme. Those amounts shall not be transferred to other actions under the national programme. 10. To effectively pursue the objectives of the Union Resettlement Programme and within the limits of available resources, the Commission shall be empowered to adopt delegated acts in accordance with Article 26 to adjust, if deemed appropriate, the lump sums referred to in paragraphs 1 and 2 of this Article, in particular taking into account the current rates of inflation, relevant developments in the field of resettlement, as well as factors which can optimise the use of the financial incentive brought by the lump sums. Article 18 Resources for the transfer of beneficiaries of international protection 1. With a view to implementing the principle of solidarity and fair sharing of responsibility and in the light of Union policy developments within the implementation period of the Fund, Member States shall receive, in addition to their allocation calculated in accordance with point (a) of Article 15(1), an additional amount as set out in point (b) of Article 15(2) based on a lump sum of EUR 6 000 for each beneficiary of international protection transferred from another Member State. 2. Member States may also be eligible for lump sums for family members of persons referred to in paragraph 1, where appropriate, provided that those family members have been transferred in accordance with this Regulation. 3. The additional amounts referred to in paragraph 1 of this Article shall be allocated to the Member States for the first time in the individual financing decisions approving their national programme in accordance with the procedure laid down in Article 14 of Regulation (EU) No 514/2014 and later in a financing decision to be annexed to the decision approving their national programme. Those amounts shall not be transferred to other actions under the national programme. 4. To effectively pursue the objectives of solidarity and responsibility sharing between the Member States referred to in Article 80 TFEU, and within the limits of available resources, the Commission shall be empowered to adopt delegated acts in accordance with Article 26 of this Regulation to adjust the lump sum referred to in paragraph 1 of this Article, in particular taking into account the current rates of inflation, relevant developments in the field of transfer of beneficiaries of international protection from one Member State to another, as well as factors which can optimise the use of the financial incentive brought by the lump sums. Article 19 National programmes 1. Under the national programmes to be examined and approved in accordance with Article 14 of Regulation (EU) No 514/2014, Member States shall, within the objectives laid down in Article 3 of this Regulation, and taking account of the outcome of the policy dialogue referred to in Article 13 of Regulation (EU) No 514/2014, pursue in particular the following objectives: (a) strengthening the establishment of the Common European Asylum System by ensuring the efficient and uniform application of the Union acquis on asylum and the proper functioning of Regulation (EU) No 604/2013. Such actions may also include the establishment and development of the Union Resettlement Programme; (b) setting up and developing integration strategies, encompassing different aspects of the two-way dynamic process, to be implemented at national/local/regional level where appropriate, taking into account the integration needs of third-country nationals at local/regional level, addressing specific needs of different categories of migrants and developing effective partnerships between relevant stakeholders; (c) developing a return programme, which includes a component on assisted voluntary return and, where appropriate, on reintegration. 2. Member States shall ensure that all actions supported under the Fund shall be implemented in full compliance with fundamental rights and respect for human dignity. In particular, such actions shall fully respect the rights and principles enshrined in the Charter of Fundamental Rights of the European Union. 3. Subject to the requirement to pursue the above objectives and taking into account their individual circumstances, Member States shall aim to achieve a fair and transparent distribution of resources among the specific objectives set out in Article 3(2). Article 20 Union actions 1. At the Commission’s initiative, the Fund may be used to finance transnational actions or actions of particular interest to the Union (‘Union actions’), concerning the general and specific objectives referred to in Article 3. 2. To be eligible for funding, Union actions shall, in particular, support: (a) the furthering of Union cooperation in implementing Union law and in sharing best practices in the field of asylum, notably on resettlement and the transfer of applicants for and/or beneficiaries of international protection from one Member State to another, including through networking and exchanging information, on legal migration, on integration of third-country nationals, including arrival support and coordination activities to promote resettlement with the local communities that are to welcome resettled refugees, and on return; (b) the setting-up of transnational cooperation networks and pilot projects, including innovative projects, based on transnational partnerships between bodies located in two or more Member States designed to stimulate innovation and to facilitate exchanges of experiences and best practices; (c) studies and research on possible new forms of Union cooperation in the field of asylum, immigration, integration and return and relevant Union law, the dissemination and exchange of information on best practices and on all other aspects of asylum, immigration, integration and return policies, including corporate communication on the political priorities of the Union; (d) the development and application by Member States of common statistical tools, methods and indicators for measuring policy developments in the field of asylum, legal migration and integration and return; (e) preparatory, monitoring, administrative and technical support and the development of an evaluation mechanism required to implement the policies on asylum and immigration; (f) cooperation with third countries on the basis of the Union’s Global Approach to Migration and Mobility, in particular in the framework of the implementation of readmission agreements, Mobility Partnerships and Regional Protection Programmes; (g) information measures and campaigns in third countries aimed at raising awareness of appropriate legal channels for immigration and the risks of illegal immigration. 3. Union actions shall be implemented in accordance with Article 6 of Regulation (EU) No 514/2014. 4. The Commission shall ensure a fair and transparent distribution of resources among the objectives referred to in Article 3(2). Article 21 Emergency assistance 1. The Fund shall provide financial assistance to address urgent and specific needs in the event of an emergency situation, as defined in point (k) of Article 2. Measures implemented in third countries in accordance with this Article shall be consistent with and, where relevant, complementary to the Union humanitarian policy and respect humanitarian principles as set out in the Consensus on Humanitarian Aid. 2. Emergency assistance shall be implemented in accordance with Articles 6 and 7 of Regulation (EU) No 514/2014. Article 22 European Migration Network 1. The Fund shall support the European Migration Network and provide the financial assistance necessary for its activities and its future development. 2. The amount made available for the European Migration Network under the annual appropriations of the Fund and the work programme laying down the priorities for its activities shall be adopted by the Commission, after approval by the Steering Board, in accordance with the procedure referred to in point (a) of Article 4(5) of Decision 2008/381/EC. The decision of the Commission shall constitute a financing decision pursuant to Article 84 of Regulation (EU, Euratom) No 966/2012. 3. Financial assistance provided for the activities of the European Migration Network shall take the form of grants to the National Contact Points referred to in Article 3 of Decision 2008/381/EC and public contracts as appropriate, in accordance with Regulation (EU, Euratom) No 966/2012. The assistance shall ensure appropriate and timely financial support to those National Contact Points. Costs incurred for the implementation of actions of those National Contact Points supported through grants awarded in 2014 may be eligible from 1 January 2014. 4. Decision 2008/381/EC is amended as follows: (a) point (a) of Article 4(5) is replaced by the following: ‘(a) prepare and approve the draft work programme of activities, notably with regard to the objectives, thematic priorities and indicative amounts of the budget for each National Contact Point to ensure the proper functioning of the EMN, on the basis of a draft from the Chair;’; (b) Article 6 is amended as follows: (i) paragraph 4 is replaced by the following: ‘4. The Commission shall monitor the execution of the work programme of activities and regularly report on its execution and on the development of the EMN to the Steering Board.’; (ii) paragraphs 5 to 8 are deleted; (c) Article 11 is deleted; (d) Article 12 is deleted. Article 23 Technical assistance 1. At the initiative and/or on behalf of the Commission, up to EUR 2,5 million of the Fund shall be annually used for technical assistance in accordance with Article 9 of Regulation (EU) No 514/2014. 2. At the initiative of a Member State, the Fund may finance technical assistance activities, in accordance with Article 20 of Regulation (EU) No 514/2014. The amount set aside for technical assistance shall not exceed, for the period 2014-2020, 5,5 % of the total amount allocated to a Member State plus EUR 1 000 000. Article 24 Coordination The Commission and the Member States, together with the European External Action Service where appropriate, shall ensure that actions in and in relation to third countries are taken in synergy and in coherence with other actions outside the Union supported through Union instruments. They shall, in particular, ensure that those actions: (a) are coherent with the Union’s external policy, respect the principle of policy coherence for development and are consistent with the strategic programming documents for the region or country in question; (b) focus on non-development-oriented measures; (c) serve the interests of the Union’s internal policies and are consistent with activities undertaken inside the Union. CHAPTER VI FINAL PROVISIONS Article 25 Specific provisions concerning lump sums for resettlement and transfer of beneficiaries of international protection from one Member State to another By way of derogation from the rules on the eligibility of expenditure laid down in Article 18 of Regulation (EU) No 514/2014, in particular as regards the lump sums and flat rates, the lump sums allocated to the Member States for resettlement and/or the transfer of beneficiaries of international protection from one Member State to another pursuant to this Regulation shall be: (a) exempt from the obligation that they are to be based on statistical or historic data; and (b) granted provided that the person in respect of whom the lump sum is allocated was effectively resettled and/or transferred in accordance with this Regulation. Article 26 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 16(2), Article 17(4) and (10) and Article 18(4) shall be conferred on the Commission for a period of seven years from 21 May 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the seven-year period. The delegation of powers shall be tacitly extended for a period of three years, unless the European Parliament or the Council opposes such extension not later than three months before the end of the seven-year period. 3. The delegation of power referred to in Article 16(2), Article 17(4) and (10) and Article 18(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 16(2), Article 17(4) and (10) and Article 18(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 27 Committee procedure 1. The Commission shall be assisted by the ‘Asylum, Migration and Integration and Internal Security Funds Committee’ established by Article 59(1) of Regulation (EU) No 514/2014. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. Article 28 Review The European Parliament and the Council shall, on the basis of a proposal of the Commission, review this Regulation by 30 June 2020. Article 29 Applicability of Regulation (EU) No 514/2014 The provisions of Regulation (EU) No 514/2014 shall apply to the Fund, without prejudice to Article 4 of this Regulation. Article 30 Repeal Decisions No 573/2007/EC, No 575/2007/EC and 2007/435/EC are repealed with effect from 1 January 2014. Article 31 Transitional provisions 1. This Regulation shall not affect the continuation or modification, including the total or partial cancellation, of the projects and annual programmes concerned, until their closure, or of the financial assistance approved by the Commission on the basis of Decisions No 573/2007/EC, No 575/2007/EC and 2007/435/EC or any other legislation applying to that assistance on 31 December 2013. This Regulation shall not affect the continuation or modification, including the total or partial cancellation, of financial support approved by the Commission on the basis of Decision 2008/381/EC or any other legislation applying to that assistance on 31 December 2013. 2. When adopting decisions on co-financing under this Regulation, the Commission shall take account of measures adopted on the basis of Decisions No 573/2007/EC, No 575/2007/EC, 2007/435/EC and 2008/381/EC before 20 May 2014 which have financial repercussions during the period covered by that co-financing. 3. Sums committed for co-financing approved by the Commission between 1 January 2011 and 31 December 2014 for which the documents required for closure of the actions have not been sent to the Commission by the deadline for submitting the final report shall be automatically decommitted by the Commission by 31 December 2017, giving rise to the repayment of amounts unduly paid. 4. Amounts relating to actions which have been suspended due to legal proceedings or administrative appeals having suspensive effect shall be disregarded in calculating the amount to be automatically decommitted. 5. By 30 June 2015, Member States shall submit to the Commission evaluation reports on the results and impact of actions co-financed under Decisions No 573/2007/EC, No 575/2007/EC and 2007/435/EC concerning the period 2011-2013. 6. By 31 December 2015, the Commission shall submit to the European Parliament, to the Council, to the European Economic and Social Committee and to the Committee of the Regions ex-post evaluation reports under Decisions No 573/2007/EC, No 575/2007/EC and 2007/435/EC concerning the period 2011-2013. Article 32 Entry into force and application This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 16 April 2014. For the European Parliament The President M. SCHULZ For the Council The President D. KOURKOULAS (1) OJ C 299, 4.10.2012, p. 108. (2) OJ C 277, 13.9.2012, p. 23. (3) Position of the European Parliament of 13 March 2014 (not yet published in the Official Journal) and decision of the Council of 14 April 2014. (4) Directive 2011/95/EU of the European Parliament and of the Council of 13 December 2011 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection, for a uniform status for refugees or for persons eligible for subsidiary protection, and for the content of the protection granted (OJ L 337, 20.12.2011, p. 9). (5) Regulation (EU) No 439/2010 of the European Parliament and of the Council of 19 May 2010 establishing a European Asylum Support Office (OJ L 132, 29.5.2010, p. 11). (6) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (7) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, p. 98). (8) Council Regulation (EC) No 2007/2004 of 26 October 2004 establishing a European Agency for the Management of Operational Cooperation at the External Borders of the Member States of the European Union (OJ L 349, 25.11.2004, p. 1). (9) Regulation (EC) No 862/2007 of the European Parliament and of the Council of 11 July 2007 on Community statistics on migration and international protection and repealing Council Regulation (EEC) No 311/76 on the compilation of statistics on foreign workers (OJ L 199, 31.7.2007, p. 23). (10) Decision No 573/2007/EC of the European Parliament and of the Council of 23 May 2007 establishing the European Refugee Fund for the period 2008 to 2013 as part of the General programme ‘Solidarity and Management of Migration Flows’ and repealing Council Decision 2004/904/EC (OJ L 144, 6.6.2007, p. 1). (11) Council Decision 2007/435/EC of 25 June 2007 establishing the European Fund for the Integration of third-country nationals for the period 2007 to 2013 as part of the General programme ‘Solidarity and Management of Migration Flows’ (OJ L 168, 28.6.2007, p. 18). (12) Decision No 575/2007/EC of the European Parliament and of the Council of 23 May 2007 establishing the European Return Fund for the period 2008 to 2013 as part of the General Programme ‘Solidarity and Management of Migration Flows’ (OJ L 144, 6.6.2007, p. 45). (13) Council Directive 2001/55/EC of 20 July 2001 on minimum standards for giving temporary protection in the event of a mass influx of displaced persons and on measures promoting a balance of efforts between Member States in receiving such persons and bearing the consequences thereof (OJ L 212, 7.8.2001, p. 12). (14) Council Decision 2008/381/EC of 14 May 2008 establishing a European Migration Network (OJ L 131, 21.5.2008, p. 7). (15) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (16) Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (see page 112 of this Official Journal). (17) Regulation (EU) No 513/2014 of the European Parliament and of the Council of 16 April 2014 establishing, as part of the Internal Security Fund, the instrument for financial support for police cooperation, preventing and combating crime, and crisis management and repealing Council Decision 2007/125/JHA (see page 93 of this Official Journal). (18) Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (OJ L 347, 20.12.2013, p. 884). (19) Regulation (EU) No 604/2013 of the European Parliament and of the Council of 26 June 2013 establishing the criteria and mechanisms for determining the Member State responsible for examining an application for international protection lodged in one of the Member States by a third-country national or a stateless person (OJ L 180, 29.6.2013, p. 31). (20) Council Directive 2003/86/EC of 22 September 2003 on the right to family reunification (OJ L 251, 3.10.2003, p. 12). ANNEX I Multiannual breakdowns per Member State for the period 2014-2020 (in EUR) Member State Minimum amount % average 2011-2013 allocations ERF+IF+RF Average amount 2011-2013 TOTAL AT 5 000 000 2,65 % 59 533 977 64 533 977 BE 5 000 000 3,75 % 84 250 977 89 250 977 BG 5 000 000 0,22 % 5 006 777 10 006 777 CY 10 000 000 0,99 % 22 308 677 32 308 677 CZ 5 000 000 0,94 % 21 185 177 26 185 177 DE 5 000 000 9,05 % 203 416 877 208 416 877 EE 5 000 000 0,23 % 5 156 577 10 156 577 ES 5 000 000 11,22 % 252 101 877 257 101 877 FI 5 000 000 0,82 % 18 488 777 23 488 777 FR 5 000 000 11,60 % 260 565 577 265 565 577 GR 5 000 000 11,32 % 254 348 877 259 348 877 HR 5 000 000 0,54 % 12 133 800 17 133 800 HU 5 000 000 0,83 % 18 713 477 23 713 477 IE 5 000 000 0,65 % 14 519 077 19 519 077 IT 5 000 000 13,59 % 305 355 777 310 355 777 LT 5 000 000 0,21 % 4 632 277 9 632 277 LU 5 000 000 0,10 % 2 160 577 7 160 577 LV 5 000 000 0,39 % 8 751 777 13 751 777 MT 10 000 000 0,32 % 7 178 877 17 178 877 NL 5 000 000 3,98 % 89 419 077 94 419 077 PL 5 000 000 2,60 % 58 410 477 63 410 477 PT 5 000 000 1,24 % 27 776 377 32 776 377 RO 5 000 000 0,75 % 16 915 877 21 915 877 SE 5 000 000 5,05 % 113 536 877 118 536 877 SI 5 000 000 0,43 % 9 725 477 14 725 477 SK 5 000 000 0,27 % 5 980 477 10 980 477 UK 5 000 000 16,26 % 365 425 577 370 425 577 MS Totals 145 000 000 100,00 % 2 247 000 000 2 392 000 000 ANNEX II List of specific actions referred to in Article 16 1. Establishment and development in the Union of transit and processing centres for refugees, in particular to support resettlement operations in cooperation with the UNHCR. 2. New approaches, in cooperation with the UNHCR, concerning access to asylum procedures targeting main countries of transit, such as protection programmes for particular groups or certain procedures for examination of applications for asylum. 3. Joint initiatives amongst Member States in the field of integration, such as benchmarking exercises, peer reviews or testing of European modules, for example on the acquisition of language skills or the organisation of introductory programmes and with the aim of improving the coordination of policies between Member States, regions and local authorities. 4. Joint initiatives aimed at the identification and implementation of new approaches concerning the procedures at first encounter and standards of protection of and assistance for unaccompanied minors. 5. Joint return operations, including joint actions on the implementation of Union readmission agreements. 6. Joint reintegration projects in the countries of origin with a view to sustainable return, as well as joint actions to strengthen third countries’ capacities to implement Union readmission agreements. 7. Joint initiatives aimed at restoring family unity and reintegration of unaccompanied minors in their countries of origin. 8. Joint initiatives among Member States in the field of legal migration, including the setting up of joint migration centres in third countries, as well as joint projects to promote cooperation between Member States with a view to encouraging the use of exclusively legal migration channels and informing about the risks of illegal immigration. ANNEX III List of common Union resettlement priorities 1. The Regional Protection Programme in Eastern Europe (Belarus, Moldova, Ukraine). 2. The Regional Protection Programme in the Horn of Africa (Djibouti, Kenya, Yemen). 3. The Regional Protection Programme in North Africa (Egypt, Libya, Tunisia). 4. Refugees in the region of Eastern Africa/Great Lakes. 5. Iraqi refugees in Syria, Lebanon, Jordan. 6. Iraqi refugees in Turkey. 7. Syrian refugees in the region. ANNEX IV List of common indicators for the measurement of the specific objectives (a) To strengthen and develop all aspects of the Common European Asylum System, including its external dimension. (i) Number of target group persons provided with assistance through projects in the field of reception and asylum systems supported under the Fund. For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down in sub-categories such as: — number of target group persons benefiting from information and assistance throughout the asylum procedures, — number of target group persons benefiting from legal assistance and representation, — number of vulnerable persons and unaccompanied minors benefiting from specific assistance; (ii) Capacity (i.e. number of places) of new reception accommodation infrastructure set up in line with the common requirements for reception conditions set out in the Union acquis and of existing reception accommodation infrastructure improved in accordance with the same requirements as a result of the projects supported under the Fund and percentage in the total reception accommodation capacity; (iii) Number of persons trained in asylum-related topics with the assistance of the Fund, and that number as a percentage of the total number of staff trained in those topics; (iv) Number of country-of-origin information products and fact-finding missions conducted with the assistance of the Fund; (v) Number of projects supported under the Fund to develop, monitor and evaluate asylum policies in Member States; (vi) Number of persons resettled with support of the Fund. (b) To support legal migration to the Member States in accordance with their economic and social needs, such as labour market needs, while reducing the abuse of legal migration, and to promote the effective integration of third-country nationals. (i) Number of target group persons who participated in pre-departure measures supported under the Fund; (ii) Number of target group persons assisted by the Fund through integration measures in the framework of national, local and regional strategies. For the purposes of annual implementation reports, as referred to in Article 54 of Regulation (EU) No 514/2014, this indicator shall be further broken down in sub-categories such as: — number of target group persons assisted through measures focusing on education and training, including language training and preparatory actions to facilitate access to the labour market, — number of target group persons supported through the provision of advice and assistance in the area of housing, — number of target group persons assisted through the provision of health and psychological care, — number of target group persons assisted through measures related to democratic participation; (iii) Number of local, regional and national policy frameworks/measures/tools in place for the integration of third-country nationals and involving civil society and migrant communities, as well as all other relevant stakeholders, as a result of the measures supported under the Fund; (iv) Number of cooperation projects with other Member States on the integration of third-country nationals supported under the Fund; (v) Number of projects supported under the Fund to develop, monitor and evaluate integration policies in Member States. (c) To enhance fair and effective return strategies in the Member States supporting the fight against illegal immigration with an emphasis on sustainability of return and effective readmission in the countries of origin and transit. (i) Number of persons trained on return-related topics with the assistance of the Fund; (ii) Number of returnees who received pre or post return reintegration assistance co-financed by the Fund; (iii) Number of returnees whose return was co-financed by the Fund, persons who returned voluntarily and persons who were removed; (iv) Number of monitored removal operations co-financed by the Fund; (v) Number of projects supported under the Fund to develop, monitor and evaluate return policies in Member States. (d) To enhance the solidarity and responsibility sharing between the Member States, in particular towards those most affected by migration and asylum flows. (i) Number of applicants and beneficiaries of international protection transferred from one Member State to another with support of the Fund; (ii) Number of cooperation projects with other Member States on enhancing solidarity and responsibility sharing between the Member States supported under the Fund.

Asylum, Migration and Integration Fund (AMIF) Asylum, Migration and Integration Fund (AMIF) SUMMARY OF: Regulation (EU) No 516/2014 on establishing the Asylum, Migration and Integration Fund WHAT IS THE AIM OF THE REGULATION? This regulation establishes the Asylum, Migration and Integration Fund. This fund aims to contribute to the efficient management of migration flows and improve the implementation and development of the common policy on immigration and asylum of the European Union (EU). The EU’s Asylum, Migration and Integration Fund (AMIF) has 4 main objectives: strengthening and developing all aspects of the Common European Asylum System, including its external dimension; supporting legal migration to the EU Member States in accordance with their economic and social needs, such as labour market needs, and promoting the effective integration of nationals from non-EU countries; enhancing return strategies in the Member States, with an emphasis on the sustainability of return and effective readmission in the countries of origin; enhancing solidarity and the sharing of responsibility between the Member States, in particular for those most affected by migration and asylum flows. KEY POINTS All Member States (except Denmark, which is not participating in this fund) prepare national programmes outlining the actions through which they intend to achieve the objectives set out in the AMIF regulation. Examples of actions include measures to support: reception and asylum systems (such as improved administrative structures, training of staff dealing with asylum procedures and developing alternatives to detention); integration measures, with a focus on the local level (such as the provision of training and services to non-EU nationals and the sharing of best practices among EU Member States); voluntary return programmes, reintegration measures, etc. While most of the fund’s budget is allocated to the national programmes, part of it is used for EU-level actions (‘Union actions’), emergency assistance, the European Migration Network and technical assistance at the initiative of the European Commission. Specific actions In addition to their national programme allocation, Member States may receive an additional amount for the implementation of specific actions. These actions (listed in Annex II), require Member States to cooperate with each other and generate significant added value for the EU. Union resettlement programme Each Member State may also receive, every 2 years, an additional amount based on a lump sum of €6,000 for each resettled person, which will be increased to €10,000 for common priorities (such as regional protection programmes) and vulnerable groups of persons. Budget The financial envelope for the implementation of the fund for 2014-2020 was initially set at €3.137 billion, which has been more than doubled over the financial period 2014-2020, mainly due to the migration crisis in 2015-2016. Details regarding the implementation of the fund are to be found in Regulation (EU) No 514/2014 (see summary). FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2014. BACKGROUND For more information, see: Asylum, Migration and Integration fund (2014-2020) (European Commission). MAIN DOCUMENT Regulation (EU) No 516/2014 of 16 April 2014 establishing the Asylum, Migration and Integration Fund, amending Council Decision 2008/381/EC and repealing Decisions No 573/2007/EC and No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC (OJ L 150, 20.5.2014, pp. 168–194) Successive amendments to Regulation (EU) No 516/2014 have been incorporated into the basic text. This consolidated version is of documentary value only. RELATED DOCUMENTS Commission Delegated Regulation (EU) 2020/445 of 15 October 2019 amending Annex II to Regulation (EU) No 516/2014 of the European Parliament and of the Council establishing the Asylum, Migration and Integration Fund (OJ L 94, 27.3.2020, pp. 1–2) Regulation (EU) 2018/2000 of the European Parliament and of the Council of 12 December 2018 amending Regulation (EU) No 516/2014 of the European Parliament and of the Council, as regards the recommitment of the remaining amounts committed to support the implementation of Council Decisions (EU) 2015/1523 and (EU) 2015/1601 or the allocation of those amounts to other actions under the national programmes (OJ L 328, 21.12.2018, pp. 78–81) Regulation (EU) No 514/2014 of the European Parliament and of the Council of 16 April 2014 laying down general provisions on the Asylum, Migration and Integration Fund and on the instrument for financial support for police cooperation, preventing and combating crime, and crisis management (OJ L 150, 20.5.2014, pp. 112–142) last update 03.09.2021

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22.5.2019 EN Official Journal of the European Union L 136/28 DIRECTIVE (EU) 2019/771 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) In order to remain competitive on global markets, the Union needs to improve the functioning of the internal market and successfully meet the multiple challenges posed today by an increasingly technology-driven economy. The Digital Single Market Strategy lays down a comprehensive framework facilitating the integration of the digital dimension into the internal market. The first pillar of the Digital Single Market Strategy tackles fragmentation in intra-EU trade by looking at all major obstacles to the development of cross-border e-commerce, which constitutes the most significant part of cross-border business-to-consumer sales of goods. (2) Article 26(1) and (2) of the Treaty on the Functioning of the European Union (TFEU) provide that the Union is to adopt measures with the aim of establishing or ensuring the functioning of the internal market, which is to comprise an area without internal frontiers in which the free movement of goods and services is ensured. Article 169(1) and point (a) of Article 169(2) TFEU provide that the Union is to contribute to the attainment of a high level of consumer protection through measures adopted pursuant to Article 114 TFEU in the context of the completion of the internal market. Τhis Directive aims to strike the right balance between achieving a high level of consumer protection and promoting the competitiveness of enterprises, while ensuring respect for the principle of subsidiarity. (3) Certain aspects concerning contracts for the sale of goods should be harmonised, taking as a base a high level of consumer protection, in order to achieve a genuine digital single market, increase legal certainty and reduce transaction costs, in particular for small and medium-sized enterprises (‘SMEs’). (4) E-commerce is a key driver for growth within the internal market. However, its growth potential is far from being fully exploited. In order to strengthen Union competitiveness and to boost growth, the Union needs to act swiftly and encourage economic actors to unleash the full potential offered by the internal market. The full potential of the internal market can only be unleashed if all market participants enjoy smooth access to cross-border sales of goods including in e-commerce transactions. The contract law rules on the basis of which market participants conclude transactions are among the key factors shaping business decisions as to whether to offer goods cross-border. Those rules also influence consumers' willingness to embrace and trust this type of purchase. (5) Technological evolution has led to a growing market for goods that incorporate or are inter-connected with digital content or digital services. Due to the increasing number of such devices and their rapidly growing uptake by consumers, action at Union level is needed in order to ensure that there is a high level of consumer protection and to increase legal certainty as regards the rules applicable to contracts for the sale of such products. Increasing legal certainty would help to reinforce the trust of consumers and sellers. (6) Union rules applicable to the sales of goods are still fragmented, although rules on delivery conditions and, as regards distance or off-premises contracts, pre-contractual information requirements and the right of withdrawal have already been fully harmonised by Directive 2011/83/EU of the European Parliament and of the Council (3). Other key contractual elements, such as the conformity criteria, the remedies for a lack of conformity with the contract and the main modalities for their exercise, are currently subject to minimum harmonisation under Directive 1999/44/EC of the European Parliament and of the Council (4). Member States have been allowed to go beyond the Union standards and introduce or maintain rules that ensure that an even higher level of consumer protection is achieved. In doing so, they have acted on different elements and to different extents. Thus, national provisions transposing Directive 1999/44/EC significantly diverge today on essential elements, such as the absence or existence of a hierarchy of remedies. (7) Existing disparities can adversely affect businesses and consumers. Pursuant to Regulation (EC) No 593/2008 of the European Parliament and of the Council (5), businesses directing their activities to consumers in other Member States are required to take account of the mandatory consumer contract law rules of the consumer's country of habitual residence. As those rules differ among Member States, businesses can be faced with additional costs. Consequently, many businesses might prefer to continue trading domestically or only export to one or two Member States. That choice of minimising exposure to costs and risks associated with cross-border trade results in lost opportunities for commercial expansion and economies of scale. SMEs in particular, are affected. (8) While consumers enjoy a high level of protection when they purchase from abroad as a result of the application of Regulation (EC) No 593/2008, legal fragmentation also negatively affects consumers' levels of confidence in cross-border transactions. While several factors contribute to this mistrust, uncertainty about key contractual rights ranks prominently among consumers' concerns. This uncertainty exists independently of whether or not consumers are protected by the mandatory consumer contract law rules of their own Member State in the event that sellers direct their cross-border activities to them, or of whether or not consumers conclude cross-border contracts with sellers without the respective seller pursuing commercial activities in the consumer's Member State. (9) While online sales of goods constitute the vast majority of cross-border sales in the Union, differences in national contract laws equally affect retailers using distance sales channels and retailers selling face-to-face and prevent them from expanding across borders. This Directive should cover all sales channels, in order to create a level playing field for all businesses selling goods to consumers. By laying down uniform rules across sales channels, this Directive should avoid any divergence that would create disproportionate burdens for the growing number of omni-channel retailers in the Union. The need for retaining consistent rules on sales and guarantees for all sales channels was confirmed in the Commission's Fitness Check on consumer and marketing law published on 29 May 2017, which also covered Directive 1999/44/EC. (10) This Directive should cover rules applicable to the sales of goods, including goods with digital elements, only in relation to key contract elements needed to overcome contract-law related barriers in the internal market. For this purpose, rules on requirements for conformity, remedies available to consumers for a lack of conformity of the goods with the contract and on the main modalities for their exercise should be fully harmonised, and the level of consumer protection, as compared to Directive 1999/44/EC, should be increased. Fully harmonised rules on some essential elements of consumer contract law would make it easier for businesses, especially SMEs, to offer their products in other Member States. Consumers would benefit from a high level of consumer protection and welfare gains by fully harmonising key rules. (11) This Directive complements Directive 2011/83/EU. While Directive 2011/83/EU mainly lays down provisions regarding pre-contractual information requirements, the right of withdrawal from distance and off-premises contracts and rules on delivery and passing of risk, this Directive introduces rules on conformity of the goods, remedies in the event of a lack of conformity and modalities for their exercise. (12) This Directive should only apply to tangible movable items that constitute goods within the meaning laid down in this Directive. Member States should therefore be free to regulate contracts for the sale of immovable property, such as residential buildings, and its main components intended to constitute a major part of such immovable property. (13) This Directive and Directive (EU) 2019/770 of the European Parliament and of the Council (6) should complement each other. While Directive (EU) 2019/770 lays down rules on certain requirements concerning contracts for the supply of digital content or digital services, this Directive lays down rules on certain requirements concerning contracts for the sale of goods. Accordingly, in order to meet the expectations of consumers and ensure a clear-cut and simple legal framework for traders of digital content or digital services, Directive (EU) 2019/770 applies to the supply of digital content or digital services, including digital content supplied on a tangible medium, such as DVDs, CDs, USB sticks and memory cards, as well as to the tangible medium itself, provided that the tangible medium serves exclusively as a carrier of the digital content. In contrast, this Directive should apply to contracts for the sale of goods, including goods with digital elements which require digital content or a digital service in order to perform their functions. (14) The term ‘goods’ as provided for under this Directive should be understood to include ‘goods with digital elements’, and therefore to also refer to any digital content or digital service that is incorporated in or inter-connected with such goods, in such a way that the absence of that digital content or digital service would prevent the goods from performing their functions. Digital content that is incorporated in or inter-connected with a good can be any data which are produced and supplied in digital form, such as operating systems, applications and any other software. Digital content can be pre-installed at the moment of the conclusion of the sales contract or, where that contract so provides, can be installed subsequently. Digital services inter-connected with a good can include services which allow the creation, processing or storage of data in digital form, or access thereto, such as software-as-a-service offered in the cloud computing environment, the continuous supply of traffic data in a navigation system, or the continuous supply of individually adapted training plans in the case of a smart watch. (15) This Directive should apply to contracts for the sale of goods, including goods with digital elements where the absence of the incorporated or inter-connected digital content or digital service would prevent the goods from performing their functions and where that digital content or service is provided with the goods under the sales contract concerning those goods. Whether the supply of the incorporated or inter-connected digital content or digital service forms part of the sales contract with the seller should depend on the content of this contract. This should include incorporated or inter-connected digital content or digital services the supply of which is explicitly required by the contract. It should also include sales contracts which can be understood as covering the supply of specific digital content or a specific digital service because they are normal for goods of the same type and the consumer could reasonably expect them given the nature of the goods and taking into account any public statement made by or on behalf of the seller or other persons in previous links of the chain of transactions, including the producer. If, for example, a smart TV were advertised as including a particular video application, that video application would be considered to be part of the sales contract. This should apply regardless of whether the digital content or digital service is pre-installed in the good itself or has to be downloaded subsequently on another device and is only inter-connected to the good. For example, a smart phone could come with a standardised pre-installed application provided under the sales contract, such as an alarm application or a camera application. Another possible example is that of a smart watch. In such a case, the watch itself would be considered to be the good with digital elements, which can perform its functions only with an application that is provided under the sales contract but has to be downloaded by the consumer onto a smart phone; the application would then be the inter-connected digital element. This should also apply if the incorporated or inter-connected digital content or digital service is not supplied by the seller itself but is supplied, under the sales contract, by a third party. In order to avoid uncertainty for both sellers and consumers, in the event of doubt as to whether the supply of the digital content or the digital service forms part of the sales contract, the rules of this Directive should apply. Furthermore, ascertaining a bilateral contractual relationship, between the seller and the consumer, of which the supply of the incorporated or inter-connected digital content or digital service forms part should not be affected by the mere fact that the consumer has to consent to a licensing agreement with a third party in order to benefit from the digital content or the digital service. (16) In contrast, if the absence of the incorporated or inter-connected digital content or digital service does not prevent the goods from performing their functions, or if the consumer concludes a contract for the supply of digital content or a digital service which does not form part of the contract concerning the sale of goods with digital elements, that contract should be considered to be separate from the contract for the sale of the goods, even if the seller acts as an intermediary of that second contract with the third-party supplier, and could fall within the scope of Directive (EU) 2019/770 if the conditions of that Directive are met. For instance, if the consumer downloads a game application from an app store onto a smart phone, the contract for the supply of the game application is separate from the contract for the sale of the smart phone itself. This Directive should therefore only apply to the sales contract concerning the smart phone, while the supply of the game application should fall under Directive (EU) 2019/770, if the conditions of that Directive are met. Another example would be where it is expressly agreed that the consumer buys a smart phone without a specific operating system and the consumer subsequently concludes a contract for the supply of an operating system from a third party. In such a case, the supply of the separately bought operating system would not form part of the sales contract and therefore would not fall within the scope of this Directive but could fall within the scope of Directive (EU) 2019/770, if the conditions of that Directive are met. (17) For the purpose of legal clarity this Directive should lay down a definition of a sales contract and also clearly define its scope. The scope of this Directive should also cover contracts for goods that are yet to be produced or manufactured, including under the consumer's specifications. Furthermore, an installation of the goods could fall within the scope of this Directive if the installation forms part of the sales contract and has to be carried out by the seller or under the seller's responsibility. Where a contract includes elements of both sales of goods and provision of services, it should be left to national law to determine whether the whole contract can be classified as a sales contract within the meaning of this Directive. (18) This Directive should not affect national law to the extent that the matters concerned are not regulated by this Directive, in particular with regard to the legality of the goods, damages and general contract law aspects such as the formation, validity, nullity or effects of contracts. The same should apply in relation to the consequences of the termination of the contract and to certain aspects regarding repair and replacement that are not regulated in this Directive. When regulating the rights of parties to withhold the performance of their obligations or part thereof until the other party performs its obligations, Member States should remain free to regulate the conditions and modalities regarding the withholding of payment of the price by the consumer. Member States should also remain free to regulate the consumer's entitlement to compensation for damage suffered as a consequence of an infringement by the seller of this Directive. This Directive should also not affect national rules that do not specifically concern consumer contracts and provide for specific remedies for certain types of defects that were not apparent at the time of conclusion of the sales contract, namely national provisions which may lay down specific rules for the seller's liability for hidden defects. This Directive should also not affect national laws providing for non-contractual remedies for the consumer, in the event of lack of conformity of goods, against persons in previous links of the chain of transactions, for example manufacturers, or other persons that fulfil the obligations of such persons. (19) This Directive should not affect the freedom of Member States to allow consumers to choose a specific remedy if the lack of conformity of the goods becomes apparent shortly after delivery, namely national provisions which provide for a right for the consumer to reject goods with a defect and to treat the contract as repudiated or ask for immediate replacement, within a specific short period of time after the delivery of the goods, which should not exceed 30 days. (20) Member States should remain free to regulate information obligations of the seller in connection with the conclusion of the contract or the duty of the seller to warn the consumer about, for instance, certain characteristics of the good, the suitability of materials provided by the consumer or possible disadvantages resulting from specific requests of the consumer, for example a request by the consumer to use a specific fabric for the tailoring of a ball gown. (21) Member States should also remain free to extend the application of the rules of this Directive to contracts that are excluded from the scope of this Directive, or to otherwise regulate such contracts. For instance, Member States should remain free to extend the protection afforded to consumers by this Directive also to natural or legal persons that are not consumers within the meaning of this Directive, such as non-governmental organisations, start-ups or SMEs. (22) The definition of a consumer should cover natural persons who are acting outside their trade, business, craft or profession. However, Member States should also remain free to determine in the case of dual purpose contracts, where the contract is concluded for purposes that are partly within and partly outside the person's trade, and where the trade purpose is so limited as not to be predominant in the overall context of the contract, whether, and under which conditions, that person should also be considered a consumer. (23) This Directive should apply to any contract whereby the seller transfers or undertakes to transfer the ownership of goods to the consumer. Platform providers could be considered to be sellers under this Directive if they act for purposes relating to their own business and as the direct contractual partner of the consumer for the sale of goods. Member States should remain free to extend the application of this Directive to platform providers that do not fulfil the requirements for being considered a seller under this Directive. (24) In order to balance the need for legal certainty with an appropriate flexibility of the legal rules, any reference in this Directive to what can be expected from or by a person should be understood as a reference to what can reasonably be expected. The standard of reasonableness should be objectively ascertained, having regard to the nature and purpose of the contract, the circumstances of the case and to the usages and practices of the parties involved. (25) In order to provide clarity as to what a consumer can expect from the goods and what the seller would be liable for in the event of failure to deliver what is expected, it is essential to fully harmonise rules for determining whether goods are in conformity. Any reference to conformity in this Directive should refer to conformity of the goods with the sales contract. In order to safeguard the legitimate interests of both parties to a sales contract, conformity should be assessed based on both subjective and objective requirements for conformity. (26) Therefore, the goods should comply with the requirements agreed between the seller and the consumer in the sales contract. Such requirements could cover, inter alia, the quantity, quality, type and description of the goods, their fitness for a specific purpose, as well as the delivery of the goods with the agreed accessories and any instructions. The requirements in the sales contract should include those resulting from pre-contractual information which, in accordance with Directive 2011/83/EU, forms an integral part of the sales contract. (27) The notion of functionality should be understood to refer to the ways in which the goods can perform their functions having regard to their purpose. The notion of interoperability relates to whether and to what extent the goods are able to function with hardware or software that is different from those with which goods of the same type are normally used. Successful functioning could include, for instance, the ability of the goods to exchange information with such other software or hardware and to use the information exchanged. (28) Given that the digital content or digital services incorporated in or inter-connected with goods are constantly developing, sellers may agree with consumers to provide updates for such goods. Updates, as agreed in the sales contract, can improve and enhance the digital content or digital service element of goods, extend their functionalities, adapt them to technical developments, protect them against new security threats or serve other purposes. The conformity of goods with digital content or digital services which are incorporated in or inter-connected with the goods should, therefore, also be assessed in relation to whether the digital content or digital service element of such goods is updated in accordance with the sales contract. Failure to supply updates that had been agreed in the sales contract should be considered as a lack of conformity of the goods. Moreover, defective or incomplete updates should also be considered as a lack of conformity of the goods, given that that would mean that such updates are not performed in the manner stipulated in the sales contract. (29) In order to be in conformity, the goods should not only comply with the subjective requirements for conformity but should in addition comply with the objective requirements for conformity set out in this Directive. Conformity should be assessed, inter alia, by considering the purpose for which goods of the same type would normally be used, whether they are supplied with the accessories and instructions that the consumer can reasonably expect to receive or whether they correspond to the sample or model that the seller made available to the consumer. The goods should also possess the qualities and features which are normal for goods of the same type and which the consumer can reasonably expect, given the nature of the goods and taking into account any public statement made by or on behalf of the seller or other persons in previous links of the chain of transactions. (30) In addition to contractually agreed updates, the seller should also provide updates, including security updates, in order to ensure that goods with digital elements remain in conformity. The seller's obligation should be limited to updates which are necessary for such goods to maintain their conformity with the objective and subjective requirements for conformity laid down in this Directive. Unless the parties have contractually agreed otherwise, the seller should not be obliged to provide upgraded versions of the digital content or digital service of the goods or to improve or extend the functionalities of goods beyond the conformity requirements. If an update provided by the seller, or by a third party supplying the digital content or digital service under the sales contract, causes a lack of conformity of the good with digital elements, the seller should be liable for bringing the good into conformity again. The consumer should remain free to choose whether to install the updates provided. Where the consumer decides not to install the updates which are necessary for the goods with digital elements to maintain their conformity, the consumer should however not expect such goods to remain in conformity. The seller should inform the consumer that the consumer's decision not to install updates which are necessary for keeping the goods with digital elements in conformity, including security updates, will affect the seller's liability for conformity of those features of the goods with digital elements which the relevant updates are supposed to maintain in conformity. This Directive should not affect obligations to provide security updates laid down in other Union law or in national law. (31) In principle, in the case of goods with digital elements whereby the digital content or digital service incorporated in or inter-connected with the goods is supplied through a single act of supply, the seller should only be liable for a lack of conformity that exists at the time of delivery. However, the obligation to provide updates should reflect the fact that the digital environment of any such good constantly changes. Therefore, updates are a necessary tool in order to ensure that the goods are able to function in the same way that they did at the time of delivery. Furthermore, in contrast to traditional goods, goods with digital elements are not completely separate from the seller's sphere because the seller, or a third person supplying the digital content or digital service under the sales contract, is able to update the goods from a distance, usually over the internet. Therefore, if the digital content or digital service is supplied by a single act of supply, the seller should be liable to provide the updates necessary to keep the goods with digital elements in conformity for a period of time that the consumer can reasonably expect, even if the goods were in conformity at the time of delivery. The period of time during which the consumer can reasonably expect to receive updates should be assessed based on the type and purpose of the goods and the digital elements, and taking into account the circumstances and nature of the sales contract. A consumer would normally expect to receive updates for at least as long as the period during which the seller is liable for a lack of conformity, while in some cases the consumer's reasonable expectation could extend beyond that period, as might be the case particularly with regard to security updates. In other cases, for instance as regards goods with digital elements the purpose of which is limited in time, the seller's obligation to provide updates would normally be limited to that time. (32) Ensuring longer durability of goods is important for achieving more sustainable consumption patterns and a circular economy. Similarly, keeping non-compliant products out of the Union market by strengthening market surveillance and providing the right incentives to economic operators is essential in order to increase trust in the functioning of the internal market. For those purposes, product-specific Union legislation is the most appropriate means of introducing durability and other product-related requirements in relation to specific types or groups of products, using for this purpose adapted criteria. This Directive should therefore be complementary to the objectives pursued in such Union product-specific legislation, and should include durability as an objective criterion for the assessment of conformity of goods. Durability in this Directive should refer to the ability of the goods to maintain their required functions and performance through normal use. In order for goods to be in conformity, they should possess the durability which is normal for goods of the same type and which the consumer can reasonably expect given the nature of the specific goods, including the possible need for reasonable maintenance of the goods, such as the regular inspection or changing of filters in a car, and any public statement made by or on behalf of any person constituting a link in the chain of transactions. The assessment should also take into account all other relevant circumstances, such as the price of the goods and the intensity or frequency of the use that the consumer makes of the goods. In addition, insofar as specific durability information is indicated in any pre-contractual statement which forms part of the sales contract, the consumer should be able to rely on them as a part of the subjective requirements for conformity. (33) Under this Directive, the seller should be obliged to deliver to the consumer goods which are in conformity at the time of delivery. It is possible that sellers would make use of spare parts in order to fulfil their obligation to repair goods in the event of a lack of conformity that existed at the time of delivery. While this Directive should not impose an obligation on sellers to ensure the availability of spare parts throughout a period of time as an objective requirement for conformity, it should not affect other provisions of national law obliging the seller, the producer or other person constituting a link in the chain of transactions, to ensure that spare parts are available or to inform consumers about such availability. (34) A large number of goods have to be installed before they can be used effectively by the consumer. In addition, in the case of goods with digital elements, the installation of the digital content or digital service is usually necessary for the consumer to be able to use such goods in line with their intended purpose. Therefore, any lack of conformity resulting from an incorrect installation of the goods, including from the incorrect installation of the digital content or digital service incorporated in or inter-connected with the goods, should be regarded as a lack of conformity, where the installation was performed by the seller or under the seller's control. Where the goods were intended to be installed by the consumer, a lack of conformity resulting from incorrect installation should be regarded as a lack of conformity of the goods, irrespective of whether the installation was performed by the consumer or by a third party under the consumer's responsibility, if the incorrect installation was due to shortcomings in the installation instructions, such as incompleteness or a lack of clarity making the installation instructions difficult to use for the average consumer. (35) Conformity should cover material defects as well as legal defects. Restrictions resulting from a violation of third-party rights, in particular intellectual property rights, could prevent or limit the use of the goods in accordance with the contract. Member States should ensure that in such cases the consumer is entitled to remedies for the lack of conformity as set out in this Directive, unless national law provides for the nullity of the contract or for its rescission in such cases. (36) In order to ensure that there is sufficient flexibility in the rules, for instance in relation to the sale of second-hand goods, it should be possible for the parties to deviate from the objective requirements for conformity provided for in this Directive. Such a deviation should only be possible if the consumer was specifically informed about it and if the consumer accepts it separately from other statements or agreements, and by way of active and unequivocal conduct. (37) Enhancing legal certainty for both consumers and sellers requires a clear indication of the time when the conformity of the goods should be assessed. The relevant time for assessing the conformity of the goods should be the time when the goods are delivered. This should also apply to goods which incorporate or are inter-connected with digital content or a digital service supplied through a single act of supply. However, where the digital content or digital service incorporated in or inter-connected with the goods is to be supplied continuously over a period of time, the relevant time for the purpose of establishing conformity of that digital content or digital service element should not be one specific moment in time but rather a period of time, starting from the time of delivery. For reasons of legal certainty, that period of time should be equal to the period during which the seller is liable for a lack of conformity. (38) This Directive should not regulate the meaning of ‘delivery’, which should be left to national law, in particular, as regards the question of what the seller has to do in order to fulfil the seller's obligation to deliver the goods. Furthermore, references to the time of delivery in this Directive should be without prejudice to the rules on the passing of risk provided for in Directive 2011/83/EU and accordingly implemented in the law of the Member States. (39) Goods with digital elements should be deemed to have been delivered to the consumer when both the physical component of the goods has been delivered and the single act of supply of the digital content or digital service has been performed or the continuous supply of the digital content or digital service over a period of time has begun. This means that the seller should also make the digital content or digital service available or accessible to the consumer in such a way that the digital content or digital service, or any means suitable for downloading or accessing it, has reached the sphere of the consumer and no further action is required by the seller in order to enable the consumer to use the digital content or digital service in accordance with the contract, for example by providing a link or a download option. Therefore, the relevant moment for establishing conformity should be the time when the digital content or digital service is supplied, if the physical component was delivered earlier. As a result, it can be ensured that there is a uniform starting point for the liability period for the physical component, on the one hand, and for the digital element on the other hand. Moreover, in many cases the consumer is unable to notice a defect in the physical component before the digital content or digital service is supplied. (40) Where goods require installation by the seller, the consumer in certain cases is unable to use the goods or notice a defect before the installation has been completed. Accordingly, where, under the sales contract, the goods are to be installed by the seller or under the seller's responsibility, the goods should be considered to be delivered to the consumer when the installation is complete. (41) In order to ensure that there is legal certainty for sellers and overall consumer confidence in cross-border purchases, it is necessary to provide for a period during which the consumer is entitled to remedies for any lack of conformity that exists at the relevant time for establishing conformity. Given that when implementing Directive 1999/44/EC, a large majority of Member States have provided for a period of two years, and in practice that period is considered reasonable by market participants, that period should be maintained. The same period should apply in the case of goods with digital elements. However, where the contract provides for continuous supply for more than two years, the consumer should be entitled to remedies for any lack of conformity of the digital content or the digital service that occurs or becomes apparent within the period during which the digital content or digital service is to be supplied under the contract. In order to ensure that there is flexibility for Member States to increase the level of consumer protection in their national law, Member States should be free to provide for longer time limits for the liability of the seller than those laid down in this Directive. (42) For reasons of coherence with the existing national legal systems, Member States should be free to provide either that sellers are liable for a lack of conformity that becomes apparent within a specific period of time, possibly coupled with a limitation period, or that consumers' remedies are only subject to a limitation period. In the former case, Member States should ensure that the period for the seller's liability is not circumvented by the limitation period for the consumer's remedies. While this Directive should, therefore, not harmonise the starting point of national limitation periods, it should ensure that such limitation periods do not curtail the consumers' right to exercise their remedies for any lack of conformity which becomes apparent in the period during which the seller is liable for a lack of conformity. In the latter case, Member States should be able to maintain or introduce only a limitation period for the consumer's remedies, without introducing a specific period within which the lack of conformity has to become apparent in order for the seller to be liable. In order to ensure that consumers are equally protected also in such cases, Member States should ensure that where only a limitation period applies, it should still allow consumers to exercise the remedies for any lack of conformity that becomes apparent at least during the period of time provided for in this Directive as a liability period. (43) As regards certain aspects, different treatment of second-hand goods could be justifiable. Although a liability or limitation period of two years or more usually reconciles the interests of both the seller and the consumer, this might not be the case with regard to second-hand goods. Member States should, therefore, be allowed to enable the parties to agree on a shortened liability or limitation period for such goods. Leaving this question to a contractual agreement between the parties increases contractual freedom and ensures that the consumer has to be informed both about the nature of the good as a second-hand good, and the shortened liability or limitation period. However, such a contractually agreed period should not be shorter than one year. (44) This Directive should not regulate the conditions under which the liability period, as provided for in this Directive, or a limitation period can be suspended or interrupted. Member States should, therefore, be able to provide for the suspension or interruption of the liability period or limitation period, for example in the event of repair, replacement or negotiations between the seller and the consumer with a view to an amicable settlement. (45) For a period of one year, or for a period of two years if Member States choose to apply a two-year period, the consumer should only need to prove that the good is not in conformity, without also needing to prove that the lack of conformity actually existed at the relevant time for establishing conformity. In order to rebut the consumer's claim, the seller would need to prove that the lack of conformity did not exist at that time. In addition, in some cases the presumption that the lack of conformity existed at the relevant time for establishing conformity could be incompatible with the nature of the goods or the nature of the lack of conformity. The former could be the case with goods that by nature deteriorate, such as perishable products, for example flowers, or goods which are only intended for a single use. An example of the latter would be a lack of conformity, which can only be a result of an action by the consumer or of an evident external cause which occurred after the goods were delivered to the consumer. In the case of goods with digital elements where the contract provides for continuous supply of the digital content or digital service, the consumer should not have to prove that the digital content or digital service was not in conformity during the respective period of time for establishing conformity. In order to rebut the consumer's claim, the seller would need to prove that the digital content or digital service was in conformity during that period. (46) Member States should be allowed to maintain or introduce provisions stipulating that, in order to benefit from the consumer's rights, the consumer has to inform the seller of a lack of conformity within a period not shorter than two months from the date on which the consumer detected such lack of conformity. Member States should be allowed to ensure that consumers have a higher level of protection, by not introducing such an obligation. (47) In order to increase legal certainty and to eliminate one of the major obstacles inhibiting the internal market, this Directive should fully harmonise the remedies available to consumers for lack of conformity of goods, and the conditions under which such remedies can be exercised. In particular, in the event of lack of conformity, consumers should be entitled to have the goods brought into conformity or to receive a proportionate reduction in the price or to terminate the contract. (48) As regards bringing goods into conformity, consumers should enjoy a choice between repair or replacement. Enabling consumers to require repair should encourage sustainable consumption and could contribute to greater durability of products. The consumer's choice between repair and replacement should only be limited where the option chosen would be legally or factually impossible or would impose costs on the seller that would be disproportionate, compared to the other option available. For instance, it might be disproportionate to request the replacement of goods because of a minor scratch, where such replacement would create significant costs and the scratch could easily be repaired. (49) The seller should be allowed to refuse to bring the goods into conformity if both repair and replacement are impossible, or they would impose disproportionate costs on the seller. The same should apply if either repair or replacement is impossible and the alternative remedy would impose disproportionate costs on the seller. For instance, if goods are located in a place that is different from where they were originally delivered, the costs of postage and carriage could become disproportionate for the seller. (50) When a lack of conformity becomes apparent, the consumer should inform the seller about it in order to give the seller the opportunity to bring the good into conformity. The seller should do that within a reasonable period of time. Accordingly, the consumer should not, in principle, be immediately entitled to a price reduction or termination of the contract but should give the seller reasonable time to repair or replace the non-conforming good. If the seller has not repaired or replaced the good within that time, the consumer should be entitled to claim and obtain a price reduction or termination of the contract without waiting any longer. (51) If repair or replacement have not provided the consumer with a proper remedy for the lack of conformity, the consumer should be entitled to a price reduction or to terminate the contract. That should be the case, in particular, where the seller has not completed repair or replacement, or where it is clear from the circumstances that the seller will not complete repair or replacement, or the seller has refused to bring the goods into conformity because repair and replacement are impossible or would impose disproportionate costs on the seller. (52) In certain situations, it could be justified that the consumer should be entitled to have the price reduced or the contract terminated immediately. Where the seller has taken action to bring the goods into conformity but a lack of conformity becomes apparent subsequently, it should be objectively determined whether the consumer should accept further attempts by the seller to bring the goods into conformity, taking into account all the circumstances of the case, such as the type and the value of the goods, and the nature and the significance of the lack of conformity. In particular, for expensive or complex goods it could be justified to allow the seller another attempt to remedy the lack of conformity. It should also be taken into account whether the consumer can be expected to maintain confidence in the ability of the seller to bring the goods into conformity or not, for instance, due to the same problem appearing twice. Similarly, in certain situations, the lack of conformity could be of such a serious nature that the consumer cannot maintain confidence in the ability of the seller to bring the goods into conformity, such as where the lack of conformity severely affects the ability of the consumer to make normal use of the goods and the consumer cannot be expected to trust that repair or replacement by the seller would remedy the problem. (53) In order to maintain a balance between the rights and obligations of the contracting parties, the consumer should enjoy the right to terminate the contract only in cases where the lack of conformity is not minor. (54) Member States should be able to regulate the conditions under which the performance of the debtor can be fulfilled by another person, for example the conditions under which the seller's obligation to repair a good can be performed by the consumer or a third party at the seller's expense. (55) In order to protect consumers against the risk of extended delays, any repair or replacement should be successfully completed within a reasonable period of time. What is considered to be a reasonable time for completing a repair or replacement should correspond to the shortest possible time necessary for completing the repair or replacement. That time should be objectively determined by considering the nature and complexity of the goods, the nature and severity of the lack of conformity, and the effort needed to complete repair or replacement. When implementing this Directive, Member States should be able to interpret the notion of reasonable time for completing repair or replacement, by providing for fixed periods that could generally be considered reasonable for repair or replacement, in particular with regard to specific categories of products. (56) This Directive should not lay down provisions on where the obligations of a debtor have to be performed. This Directive should, therefore, neither specify the place of delivery, nor prescribe where the repair or replacement should take place; such questions should be left to national law. (57) Where the seller brings the good into conformity by replacement, the consumer should not be obliged to pay for the normal use of the goods before they were replaced. The use of the goods should be considered normal if it is in accordance with the nature and purpose of the goods. (58) In order to make the right to terminate effective for consumers, in situations where the consumer acquires multiple goods and the lack of conformity only affects some of the goods delivered under the contract, the consumer should have the right to terminate the contract also in relation to the other goods acquired together with the non-conforming goods, even if those other goods are in conformity, if the consumer cannot reasonably be expected to accept to keep only the conforming goods. (59) Where the consumer terminates the contract due to the lack of conformity, this Directive should prescribe rules only on the main effects of and modalities for the right of termination, in particular the obligation for the parties to return what they have received. Thus, the seller should be obliged to refund the price received from the consumer and the consumer should return the goods. (60) This Directive should not affect the freedom of Member States to regulate the consequences of termination other than those provided for in this Directive, such as the consequences of the decrease of the value of the goods or of their destruction or loss. Member States should also be allowed to regulate the modalities for reimbursement of the price to the consumer, for example the modalities concerning the means to be used for such reimbursement or concerning possible costs and fees incurred as a result of the reimbursement. Member States should, for instance, also have the freedom to provide for certain time limits for the reimbursement of the price or for the return of the goods. (61) The principle of the seller's liability for damages is an essential element of sales contracts. Consumers should, therefore, be entitled to claim compensation for any detriment caused by an infringement by the seller of this Directive, including for damage suffered as a consequence of a lack of conformity. Such compensation should put the consumer as much as possible into the position in which the consumer would have been had the goods been in conformity. As the existence of such a right to damages is already ensured in all Member States, this Directive should be without prejudice to national rules on the compensation of consumers for harm resulting from infringement of those rules. Member States should also remain free to regulate consumers' entitlement to compensation for situations in which the repair or replacement caused significant inconvenience or was delayed. (62) In order to ensure that there is transparency, certain requirements as regards commercial guarantees should be provided, alongside the pre-contractual information requirements on the existence and conditions of commercial guarantees set out in Directive 2011/83/EU. Moreover, in order to improve legal certainty and to avoid consumers being misled, this Directive should provide that, where commercial guarantee conditions contained in associated advertisements are more favourable to the consumer than those included in the guarantee statement, the more advantageous conditions should prevail. Finally, this Directive should provide rules on the content of the guarantee statement and on the way it should be made available to consumers. For instance, the guarantee statement should include the terms of the commercial guarantee and state that the legal guarantee of conformity is unaffected by the commercial guarantee, making it clear that the commercial guarantee terms constitute an undertaking that is additional to the legal guarantee of conformity. Member States should be free to lay down rules on other aspects of commercial guarantees not covered by this Directive, for example on associating debtors other than the guarantor with the commercial guarantee, provided that those rules do not deprive consumers of the protection afforded to them by the fully harmonised provisions of this Directive on commercial guarantees. While Member States should remain free to require that commercial guarantees be provided free of charge, they should ensure that any undertaking by the seller or the producer which falls under the definition of commercial guarantees as set out in this Directive complies with the harmonised rules of this Directive. (63) Considering that the seller is liable towards the consumer for any lack of conformity of the goods resulting from an act or omission of the seller or a third party, the seller should be able to pursue remedies against the person responsible in previous links of the chain of transactions. Such remedies should include those for a lack of conformity which results from the omission of an update, including a security update, which would have been necessary to keep the good with digital elements in conformity. However, this Directive should not affect the principle of freedom of contract between the seller and other parties in the chain of transactions. The details for exercising that right, in particular against whom and how such remedies are to be pursued and whether the remedies are of a mandatory nature, should be provided by the Member States. The question as to whether the consumer can also raise a claim directly against a person in previous links of the chain of transactions should not be regulated by this Directive, except in cases where a producer offers the consumer a commercial guarantee for the goods. (64) Persons or organisations regarded under national law as having a legitimate interest in protecting consumer contractual rights should be afforded the right to initiate proceedings, either before a court or before an administrative authority which is competent to decide upon complaints or to initiate appropriate legal proceedings. (65) Nothing in this Directive should prejudice the application of rules of private international law, in particular Regulation (EC) No 593/2008 and Regulation (EU) No 1215/2012 of the European Parliament and of the Council (7). (66) Directive 1999/44/EC should be repealed. The date of repeal should be aligned with the transposition date of this Directive. In order to ensure that the laws, regulations and administrative provisions necessary for Member States to comply with this Directive are applied in a uniform manner to contracts concluded from the transposition date onwards, this Directive should not apply to contracts concluded before its transposition date. (67) The Annex to Regulation (EU) 2017/2394 of the European Parliament and of the Council (8) should be amended to include a reference to this Directive so as to facilitate cross-border cooperation on enforcement of this Directive. (68) Annex I to Directive 2009/22/EC of the European Parliament and of the Council (9) should be amended to include a reference to this Directive so as to ensure that the collective interests of consumers laid down in this Directive are protected. (69) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (10), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified. (70) Since the objective of this Directive, namely to contribute to the functioning of the internal market by tackling in a consistent manner contract law-related obstacles for the cross-border sales of goods in the Union, cannot be sufficiently achieved by the Member States, due to the fact that each Member State individually is not in a position to tackle the existing fragmented legal framework by ensuring the coherence of its law with the laws of other Member States, but can rather, by removing the principal contract law-related obstacles through full harmonisation, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective. (71) It is appropriate for the Commission to review the application of this Directive five years after its entry into force, including in particular the provisions regarding remedies, the burden of proof – also with respect to second-hand goods as well as goods sold at public auctions – and the producer's commercial guarantee of durability. The Commission should also assess whether the application of this Directive and of Directive (EU) 2019/770 ensures a consistent and coherent legal framework with regard to the supply of digital content or digital services and goods with digital elements. (72) This Directive respects the fundamental rights and freedoms and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, including those enshrined in Articles 16, 38 and 47 thereof, HAVE ADOPTED THIS DIRECTIVE: Article 1 Subject matter and purpose The purpose of this Directive is to contribute to the proper functioning of the internal market while providing for a high level of consumer protection, by laying down common rules on certain requirements concerning sales contracts concluded between sellers and consumers, in particular rules on the conformity of goods with the contract, remedies in the event of a lack of such conformity, the modalities for the exercise of those remedies, and on commercial guarantees. Article 2 Definitions For the purposes of this Directive, the following definitions apply: (1) ‘sales contract’ means any contract under which the seller transfers or undertakes to transfer ownership of goods to a consumer, and the consumer pays or undertakes to pay the price thereof; (2) ‘consumer’ means any natural person who, in relation to contracts covered by this Directive, is acting for purposes which are outside that person's trade, business, craft or profession; (3) ‘seller’ means any natural person or any legal person, irrespective of whether privately or publicly owned, that is acting, including through any other person acting in that natural or legal person's name or on that person's behalf, for purposes relating to that person's trade, business, craft or profession, in relation to contracts covered by this Directive; (4) ‘producer’ means a manufacturer of goods, an importer of goods into the Union or any person purporting to be a producer by placing its name, trade mark or other distinctive sign on the goods; (5) ‘goods’ means: (a) any tangible movable items; water, gas and electricity are to be considered as goods within the meaning of this Directive where they are put up for sale in a limited volume or a set quantity; (b) any tangible movable items that incorporate or are inter-connected with digital content or a digital service in such a way that the absence of that digital content or digital service would prevent the goods from performing their functions (‘goods with digital elements’); (6) ‘digital content’ means data which are produced and supplied in digital form; (7) ‘digital service’ means: (a) a service that allows the consumer to create, process, store or access data in digital form; or (b) a service that allows the sharing of or any other interaction with data in digital form uploaded or created by the consumer or other users of that service; (8) ‘compatibility’ means the ability of the goods to function with hardware or software with which goods of the same type are normally used, without the need to convert the goods, hardware or software; (9) ‘functionality’ means the ability of the goods to perform their functions having regard to their purpose; (10) ‘interoperability’ means the ability of the goods to function with hardware or software different from those with which goods of the same type are normally used; (11) ‘durable medium’ means any instrument which enables the consumer or the seller to store information addressed personally to that person in a way that is accessible for future reference, for a period of time adequate for the purposes of the information, and which allows the unchanged reproduction of the information stored; (12) ‘commercial guarantee’ means any undertaking by the seller or a producer (the guarantor) to the consumer, in addition to the seller's legal obligation relating to the guarantee of conformity, to reimburse the price paid or to replace, repair or service goods in any way if they do not meet the specifications or any other requirements not related to conformity set out in the guarantee statement or in the relevant advertising available at the time of, or before the conclusion of the contract; (13) ‘durability’ means the ability of the goods to maintain their required functions and performance through normal use; (14) ‘free of charge’ means free of the necessary costs incurred in order to bring the goods into conformity, particularly the cost of postage, carriage, labour or materials; (15) ‘public auction’ means a method of sale where goods or services are offered by the seller to consumers, who attend or are given the possibility to attend the auction in person, through a transparent, competitive bidding procedure run by an auctioneer and where the successful bidder is bound to purchase the goods or services. Article 3 Scope 1. This Directive shall apply to sales contracts between a consumer and a seller. 2. Contracts between a consumer and a seller for the supply of goods to be manufactured or produced shall also be deemed sales contracts for the purpose of this Directive. 3. This Directive shall not apply to contracts for the supply of digital content or digital services. It shall, however, apply to digital content or digital services which are incorporated in or inter-connected with goods in the meaning of point (5)(b) of Article 2, and are provided with the goods under the sales contract, irrespective of whether such digital content or digital service is supplied by the seller or by a third party. In the event of doubt as to whether the supply of incorporated or inter-connected digital content or an incorporated or inter-connected digital service forms part of the sales contract, the digital content or digital service shall be presumed to be covered by the sales contract. 4. This Directive shall not apply to: (a) any tangible medium which serves exclusively as a carrier for digital content; or (b) any goods sold by way of execution or otherwise by authority of law. 5. Member States may exclude from the scope of this Directive contracts for the sale of: (a) second-hand goods sold at public auction; and (b) living animals. In the case referred to in point (a), clear and comprehensive information that the rights deriving from this Directive do not apply shall be made easily available to consumers. 6. This Directive shall not affect the freedom of Member States to regulate aspects of general contract law, such as rules on the formation, validity, nullity or effects of contracts, including the consequences of the termination of a contract, in so far as they are not regulated in this Directive, or the right to damages. 7. This Directive shall not affect the freedom of Member States to allow consumers to choose a specific remedy, if the lack of conformity of the goods becomes apparent within a period after delivery, not exceeding 30 days. In addition, this Directive shall not affect national rules not specific to consumer contracts providing for specific remedies for certain types of defects that were not apparent at the time of conclusion of the sales contract. Article 4 Level of harmonisation Member States shall not maintain or introduce, in their national law, provisions diverging from those laid down in this Directive, including more, or less, stringent provisions to ensure a different level of consumer protection, unless otherwise provided for in this Directive. Article 5 Conformity of goods The seller shall deliver goods to the consumer that meet the requirements set out in Articles 6, 7 and 8, where applicable, without prejudice to Article 9. Article 6 Subjective requirements for conformity In order to conform with the sales contract, the goods shall, in particular, where applicable: (a) be of the description, type, quantity and quality, and possess the functionality, compatibility, interoperability and other features, as required by the sales contract; (b) be fit for any particular purpose for which the consumer requires them and which the consumer made known to the seller at the latest at the time of the conclusion of the sales contract, and in respect of which the seller has given acceptance; (c) be delivered with all accessories and instructions, including on installation, as stipulated by the sales contract; and (d) be supplied with updates as stipulated by the sales contract. Article 7 Objective requirements for conformity 1. In addition to complying with any subjective requirement for conformity, the goods shall: (a) be fit for the purposes for which goods of the same type would normally be used, taking into account, where applicable, any existing Union and national law, technical standards or, in the absence of such technical standards, applicable sector-specific industry codes of conduct; (b) where applicable, be of the quality and correspond to the description of a sample or model that the seller made available to the consumer before the conclusion of the contract; (c) where applicable, be delivered along with such accessories, including packaging, installation instructions or other instructions, as the consumer may reasonably expect to receive; and (d) be of the quantity and possess the qualities and other features, including in relation to durability, functionality, compatibility and security normal for goods of the same type and which the consumer may reasonably expect given the nature of the goods and taking into account any public statement made by or on behalf of the seller, or other persons in previous links of the chain of transactions, including the producer, particularly in advertising or on labelling. 2. The seller shall not be bound by public statements, as referred to in point (d) of paragraph 1 if the seller shows that: (a) the seller was not, and could not reasonably have been, aware of the public statement in question; (b) by the time of conclusion of the contract, the public statement had been corrected in the same way as, or in a way comparable to how, it had been made; or (c) the decision to buy the goods could not have been influenced by the public statement. 3. In the case of goods with digital elements, the seller shall ensure that the consumer is informed of and supplied with updates, including security updates, that are necessary to keep those goods in conformity, for the period of time: (a) that the consumer may reasonably expect given the type and purpose of the goods and the digital elements, and taking into account the circumstances and nature of the contract, where the sales contract provides for a single act of supply of the digital content or digital service; or (b) indicated in Article 10(2) or (5), as applicable, where the sales contract provides for a continuous supply of the digital content or digital service over a period of time. 4. Where the consumer fails to install within a reasonable time updates supplied in accordance with paragraph 3, the seller shall not be liable for any lack of conformity resulting solely from the lack of the relevant update, provided that: (a) the seller informed the consumer about the availability of the update and the consequences of the failure of the consumer to install it; and (b) the failure of the consumer to install or the incorrect installation by the consumer of the update was not due to shortcomings in the installation instructions provided to the consumer. 5. There shall be no lack of conformity within the meaning of paragraph 1 or 3 if, at the time of the conclusion of the sales contract, the consumer was specifically informed that a particular characteristic of the goods was deviating from the objective requirements for conformity laid down in paragraph 1 or 3 and the consumer expressly and separately accepted that deviation when concluding the sales contract. Article 8 Incorrect installation of the goods Any lack of conformity resulting from the incorrect installation of the goods shall be regarded as lack of conformity of the goods, if: (a) the installation forms part of the sales contract and was carried out by the seller or under the seller's responsibility; or (b) the installation, intended to be carried out by the consumer, was done by the consumer and the incorrect installation was due to shortcomings in the installation instructions provided by the seller or, in the case of goods with digital elements, provided by the seller or by the supplier of the digital content or digital service. Article 9 Third-party rights Where a restriction resulting from a violation of any right of a third party, in particular intellectual property rights, prevents or limits the use of the goods in accordance with Articles 6 and 7, Member States shall ensure that the consumer is entitled to the remedies for lack of conformity provided for in Article 13, unless national law provides for the nullity or rescission of the sales contract in such cases. Article 10 Liability of the seller 1. The seller shall be liable to the consumer for any lack of conformity which exists at the time when the goods were delivered and which becomes apparent within two years of that time. Without prejudice to Article 7(3), this paragraph shall also apply to goods with digital elements. 2. In the case of goods with digital elements, where the sales contract provides for a continuous supply of the digital content or digital service over a period of time, the seller shall also be liable for any lack of conformity of the digital content or digital service that occurs or becomes apparent within two years of the time when the goods with digital elements were delivered. Where the contract provides for a continuous supply for more than two years, the seller shall be liable for any lack of conformity of the digital content or digital service that occurs or becomes apparent within the period of time during which the digital content or digital service is to be supplied under the sales contract. 3. Member States may maintain or introduce longer time limits than those referred to in paragraphs 1 and 2. 4. If, under national law, the remedies provided for in Article 13 are also subject to a limitation period, Member States shall ensure that such limitation period allows the consumer to exercise the remedies laid down in Article 13 for any lack of conformity for which the seller is liable pursuant to paragraphs 1 and 2 of this Article, and which becomes apparent within the period of time referred to in those paragraphs. 5. Notwithstanding paragraphs 1 and 2 of this Article, Member States may maintain or introduce only a limitation period for the remedies provided for in Article 13. Member States shall ensure that such limitation period allows the consumer to exercise the remedies laid down in Article 13 for any lack of conformity for which the seller is liable pursuant to paragraphs 1 and 2 of this Article, and which becomes apparent during the period of time referred to in those paragraphs. 6. Member States may provide that, in the case of second-hand goods, the seller and the consumer can agree to contractual terms or agreements with a shorter liability or limitation period than those referred to in paragraphs 1, 2 and 5, provided that such shorter periods shall not be less than one year. Article 11 Burden of proof 1. Any lack of conformity which becomes apparent within one year of the time when the goods were delivered shall be presumed to have existed at the time when the goods were delivered, unless proved otherwise or unless this presumption is incompatible with the nature of the goods or with the nature of the lack of conformity. This paragraph shall also apply to goods with digital elements. 2. Instead of the one-year period laid down in paragraph 1, Member States may maintain or introduce a period of two years from the time when the goods were delivered. 3. In the case of goods with digital elements where the sales contract provides for the continuous supply of the digital content or digital service over a period of time, the burden of proof with regard to whether the digital content or digital service was in conformity within the period of time referred to in Article 10(2) shall be on the seller for a lack of conformity which becomes apparent within the period of time referred to in that Article. Article 12 Obligation to notify Member States may maintain or introduce provisions stipulating that, in order to benefit from the consumer's rights, the consumer has to inform the seller of a lack of conformity within a period of at least 2 months of the date on which the consumer detected such lack of conformity. Article 13 Remedies for lack of conformity 1. In the event of a lack of conformity, the consumer shall be entitled to have the goods brought into conformity or to receive a proportionate reduction in the price, or to terminate the contract, under the conditions set out in this Article. 2. In order to have the goods brought into conformity, the consumer may choose between repair and replacement, unless the remedy chosen would be impossible or, compared to the other remedy, would impose costs on the seller that would be disproportionate, taking into account all circumstances, including: (a) the value the goods would have if there were no lack of conformity; (b) the significance of the lack of conformity; and (c) whether the alternative remedy could be provided without significant inconvenience to the consumer. 3. The seller may refuse to bring the goods into conformity if repair and replacement are impossible or would impose costs on the seller that would be disproportionate, taking into account all circumstances including those mentioned in points (a) and (b) of paragraph 2. 4. The consumer shall be entitled to either a proportionate reduction of the price in accordance with Article 15 or the termination of the sales contract in accordance with Article 16 in any of the following cases: (a) the seller has not completed repair or replacement or, where applicable, has not completed repair or replacement in accordance with Article 14(2) and (3), or the seller has refused to bring the goods into conformity in accordance with paragraph 3 of this Article; (b) a lack of conformity appears despite the seller having attempted to bring the goods into conformity; (c) the lack of conformity is of such a serious nature as to justify an immediate price reduction or termination of the sales contract; or (d) the seller has declared, or it is clear from the circumstances, that the seller will not bring the goods into conformity within a reasonable time, or without significant inconvenience for the consumer. 5. The consumer shall not be entitled to terminate the contract if the lack of conformity is only minor. The burden of proof with regard to whether the lack of conformity is minor shall be on the seller. 6. The consumer shall have the right to withhold payment of any outstanding part of the price or a part thereof until the seller has fulfilled the seller's obligations under this Directive. Member States may determine the conditions and modalities for the consumer to exercise the right to withhold the payment. 7. Member States may regulate whether and to what extent a contribution of the consumer to the lack of conformity affects the consumer's right to remedies. Article 14 Repair or replacement of the goods 1. Repairs or replacements shall be carried out: (a) free of charge; (b) within a reasonable period of time from the moment the seller has been informed by the consumer about the lack of conformity; and (c) without any significant inconvenience to the consumer, taking into account the nature of the goods and the purpose for which the consumer required the goods. 2. Where the lack of conformity is to be remedied by repair or replacement of the goods, the consumer shall make the goods available to the seller. The seller shall take back the replaced goods at the seller's expense. 3. Where a repair requires the removal of goods that had been installed in a manner consistent with their nature and purpose before the lack of conformity became apparent, or where such goods are to be replaced, the obligation to repair or replace the goods shall include the removal of the non-conforming goods, and the installation of replacement goods or repaired goods, or bearing the costs of that removal and installation. 4. The consumer shall not be liable to pay for normal use made of the replaced goods during the period prior to their replacement. Article 15 Price reduction The reduction of price shall be proportionate to the decrease in the value of the goods which were received by the consumer compared to the value the goods would have if they were in conformity. Article 16 Termination of the sales contract 1. The consumer shall exercise the right to terminate the sales contract by means of a statement to the seller expressing the decision to terminate the sales contract. 2. Where the lack of conformity relates to only some of the goods delivered under the sales contract and there is a ground for termination of the sales contract pursuant to Article 13, the consumer may terminate the sales contract only in relation to those goods, and in relation to any other goods which the consumer acquired together with the non-conforming goods if the consumer cannot reasonably be expected to accept to keep only the conforming goods. 3. Where the consumer terminates a sales contract as a whole or, in accordance with paragraph 2, in relation to some of the goods delivered under the sales contract: (a) the consumer shall return to the seller, at the seller's expense, the goods; and (b) the seller shall reimburse to the consumer the price paid for the goods upon receipt of the goods or of evidence provided by the consumer of having sent back the goods. For the purposes of this paragraph, Member States may determine the modalities for return and reimbursement. Article 17 Commercial guarantees 1. Any commercial guarantee shall be binding on the guarantor under the conditions laid down in the commercial guarantee statement and associated advertising available at the time, or before the conclusion, of the contract. Under the conditions laid down in this Article and without prejudice to any other applicable provisions of Union or national law, where a producer offers to the consumer a commercial guarantee of durability for certain goods for a certain period of time, the producer shall be liable directly to the consumer, during the entire period of the commercial guarantee of durability for repair or replacement of the goods in accordance with Article 14. The producer may offer to the consumer more favourable conditions in the commercial guarantee of durability statement. If the conditions laid out in the commercial guarantee statement are less advantageous to the consumer than those laid down in the associated advertising, the commercial guarantee shall be binding under the conditions laid down in the advertising relating to the commercial guarantee, unless, before the conclusion of the contract, the associated advertising was corrected in the same way or in a comparable way to that in which it was made. 2. The commercial guarantee statement shall be provided to the consumer on a durable medium at the latest at the time of the delivery of the goods. The commercial guarantee statement shall be expressed in plain, intelligible language. It shall include the following: (a) a clear statement that the consumer is entitled by law to remedies from the seller free of charge in the event of a lack of conformity of the goods and that those remedies are not affected by the commercial guarantee; (b) the name and address of the guarantor; (c) the procedure to be followed by the consumer to obtain the implementation of the commercial guarantee; (d) the designation of the goods to which the commercial guarantee applies; and (e) the terms of the commercial guarantee. 3. Non-compliance with paragraph 2 shall not affect the binding nature of the commercial guarantee for the guarantor. 4. Member States may lay down rules on other aspects concerning commercial guarantees which are not regulated in this Article, including rules on the language or languages in which the commercial guarantee statement is to be made available to the consumer. Article 18 Right of redress Where the seller is liable to the consumer because of a lack of conformity resulting from an act or omission, including omitting to provide updates to goods with digital elements in accordance with Article 7(3), by a person in previous links of the chain of transactions, the seller shall be entitled to pursue remedies against the person or persons liable in the chain of transactions. The person against whom the seller may pursue remedies and the relevant actions and conditions of exercise, shall be determined by national law. Article 19 Enforcement 1. Member States shall ensure that adequate and effective means exist to ensure compliance with this Directive. 2. The means referred to in paragraph 1 shall include provisions whereby one or more of the following bodies, as determined by national law, may take action under national law before the courts or before the competent administrative bodies to ensure that the national provisions transposing this Directive are applied: (a) public bodies or their representatives; (b) consumer organisations having a legitimate interest in protecting consumers; (c) professional organisations having a legitimate interest in acting. Article 20 Consumer information Member States shall take appropriate measures to ensure that information on the rights of consumers under this Directive, and on the means to enforce those rights, are available to consumers. Article 21 Mandatory nature 1. Unless otherwise provided for in this Directive, any contractual agreement which, to the detriment of the consumer, excludes the application of national measures transposing this Directive, derogates from them, or varies their effect, before the lack of conformity of the goods is brought to the seller's attention by the consumer, shall not be binding on the consumer. 2. This Directive shall not prevent the seller from offering to the consumer contractual arrangements that go beyond the protection provided for in this Directive. Article 22 Amendments to Regulation (EU) 2017/2394 and Directive 2009/22/EC (1) In the Annex to Regulation (EU) 2017/2394, point 3 is replaced by the following: ‘3. Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC and repealing Directive 1999/44/EC (OJ L 136, 22.5.2019, p. 28).’; (2) In Annex I to Directive 2009/22/EC, point 7 is replaced by the following: ‘7. Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC and repealing Directive 1999/44/EC (OJ L 136, 22.5.2019, p. 28).’. Article 23 Repeal of Directive 1999/44/EC Directive 1999/44/EC is repealed with effect from 1 January 2022. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table set out in Annex. Article 24 Transposition 1. By 1 July 2021 Member States shall adopt and publish the measures necessary to comply with this Directive. They shall immediately inform the Commission thereof. They shall apply those measures from 1 January 2022. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. Member States shall communicate to the Commission the text of the measures of national law which they adopt in the field covered by this Directive. 2. The provisions of this Directive shall not apply to contracts concluded before 1 January 2022. Article 25 Review The Commission shall, not later than 12 June 2024, review the application of this Directive, including its provisions on remedies and burden of proof — also with respect to second-hand goods as well as goods sold at public auctions — and the producer's commercial guarantee of durability, and submit a report to the European Parliament, to the Council and to the European Economic and Social Committee. The report shall assess in particular whether the application of this Directive and Directive (EU) 2019/770 ensures a consistent and coherent framework for the proper functioning of the internal market with regard to the supply of digital content, digital services and goods with digital elements in line with principles governing Union policies. The report shall be accompanied, where appropriate, by legislative proposals. Article 26 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. However, Article 22 shall apply from 1 January 2022. Article 27 Addressees This Directive is addressed to the Member States. Done at Brussels, 20 May 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 264, 20.7.2016, p. 57. (2) Position of the European Parliament of 26 March 2019 (not yet published in the Official Journal) and decision of the Council of 15 April 2019. (3) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). (4) Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees (OJ L 171, 7.7.1999, p. 12). (5) Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) (OJ L 177, 4.7.2008, p. 6). (6) Directive (EU) 2019/770 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the supply of digital content and digital services (see page 1 of this Official Journal). (7) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). (8) Regulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017 on cooperation between national authorities responsible for the enforcement of consumer protection laws and repealing Regulation (EC) No 2006/2004 (OJ L 345, 27.12.2017, p. 1). (9) Directive 2009/22/EC of the European Parliament and of the Council of 23 April 2009 on injunctions for the protection of consumers' interests (OJ L 110, 1.5.2009, p. 30). (10) OJ C 369, 17.12.2011, p. 14. ANNEX CORRELATION TABLE Directive 1999/44/EC This Directive Article 1(1) Article 1 Article 1(2)(a) Article 2, point (2) Article 1(2)(b), first indent Article 3(4)(b) Article 1(2)(b), second and third indents Article 2, point (5)(a) Article 1(2)(c) Article 2, point (3) Article 1(2)(d) Article 2, point (4) Article 1(2)(e) Article 2, point (12) Article 1(3) Article 2, point (15) and Article 3(5)(a) Article 1(4) Article 3(2) Article 2(1) Article 5 Article 2(2)(a) Article 6, point (a) and Article 7(1)(b) Article 2(2)(b) Article 6, point (b) Article 2(2)(c) Article 7(1)(a) Article 2(2)(d) Article 7(1)(d) Article 2(3) Article 7(5) Article 2(4) Article 7(2) Article 2(5) Article 8 Article 3(1) Article 10(1) Article 3(2) Article 13(1) Article 3(3), first subparagraph Article 13(2) and Article 14(1)(a) Article 3(3), second subparagraph Article 13(2) Article 3(3), third subparagraph Article 14(1)(b) and (c) Article 3(4) Article 2, point (14) Article 3(5) Article 13(4) Article 3(6) Article 13(5) Article 4 Article 18 Article 5(1) Article 10(1), (2), (3), (4) and (5) Article 5(2) Article 12 Article 5(3) Article 11 Article 6(1) Article 17(1) Article 6(2) Article 17(2) Article 6(3) Article 17(2) Article 6(4) Article 17(4) Article 6(5) Article 17(3) Article 7(1), first subparagraph Article 21(1) Article 7(1), second subparagraph Article 10(6) Article 7(2) — Article 8(1) Article 3(6) and (7) Article 8(2) Article 4 Article 9 Articles 19 and 20 Article 10 Article 22 Article 11(1), first subparagraph Article 24(1), first subparagraph Article 11(1), second subparagraph Article 24(1), third subparagraph Article 11(2) Article 24(1), fourth subparagraph Article 12 Article 25 Article 13 Article 26 Article 14 Article 27

Rules on contracts for the sale of goods between sellers and consumers Rules on contracts for the sale of goods between sellers and consumers SUMMARY OF: Directive (EU) 2019/771 on certain aspects concerning contracts for the sale of goods WHAT IS THE AIM OF THE DIRECTIVE? It aims to ensure proper functioning of the internal market, while providing consumers with a high level of protection. It does so by laying down certain common rules on sales contracts between sellers and consumers. These cover: conformity of goods with the contract; remedies if there is no conformity; ways to exercise these remedies; commercial guarantees. KEY POINTS The legislation applies to sales contracts* between a consumer and a seller for the supply of goods*. The legislation does not apply to: the supply of digital content* or digital services*, unless these are incorporated or inter-connected with the goods themselves, necessary for them to perform their functions and provided under the sales contract (goods with digital elements); any physical medium used exclusively to carry digital content (e.g. CDs, DVDs, etc.). Sellers must ensure goods delivered to the consumer conform with the sales contract by: complying with what was contractually agreed, e.g. fit the description, type, quantity, quality and possessing the features required by the contract, being fit for the agreed purposes etc.; and complying with objective conformity criteria, i.e. be fit for the purposes for which similar goods are normally usedcorrespond to the sample or model shown to the consumerbe delivered with the accessories, instructions and packaging that the consumer can reasonably expect andpossess the qualities and features that the consumer may reasonably expect. Sellers are liable for any lack of conformity which becomes apparent within 2 years of delivery. During the first year, the consumer does not have to prove that the defect existed at the time of delivery. For goods with digital elements: sellers must inform and supply the consumer with all updates needed to keep them in conformity for the duration that the consumer may reasonably expect, unless the digital element of the goods is supplied continuously, in which case updates should be provided throughout the period of supply; sellers are liable for any lack of conformity which becomes apparent within 2 years of delivery, unless the digital element is to be supplied continuously for a longer period, in which case the seller is liable throughout the period of supply. If goods are defective (‘lack of conformity’), consumers are entitled to the following remedies: choice between repair and replacement of the goods, free of charge, within a reasonable time and without any major inconvenience. The seller can give the alternative remedy if the one chosen is impossible or involves disproportionate costs for the seller; a proportionate reduction in price; termination of the contract, except if the defect is only minor. Commercial guarantees: are binding on the guarantor under the conditions laid down in the guarantee statement and associated advertising, whichever is more advantageous to the consumer; must be provided to the consumer in plain, intelligible language and a way that it is accessible for future reference; include: confirmation the consumer is entitled by law to remedies from the seller for any defects free of chargename and address of the guarantorthe procedure for implementing, and the terms of, the guarantee. EU countries may: exclude from the legislation second-hand goods sold at public auction, and live animals; regulate aspects of general contract law or the right to damages where these are not covered by the directive; allow consumers to choose a specific remedy if the goods’ lack of conformity becomes apparent within 30 days of delivery, or maintain specific rules on guarantees for hidden defects. EU countries: must not apply measures, including more or less stringent consumer protection provisions, different from those in the directive; are allowed to apply longer time limits for seller liability than those in the directive; may stipulate that to benefit from consumer rights the customer must inform the seller within 2 months of detecting the defect; ensure adequate and effective means exist to ensure compliance with the legislation; inform consumers of their rights under the directive and how these may be enforced; adopt and publish the measures set out in the legislation by 1 July 2021. The European Commission submits a report to the European Parliament, the Council and the European Economic and Social Committee by 12 June 2024 on implementation of the directive. Repeal Directive (EU) 2019/771 repeals and replaces Directive 1999/44/EC (Consumer Sales and Guarantees Directive — CSGD) as of 1 January 2022. FROM WHEN DOES THE DIRECTIVE APPLY? EU countries have to apply the rules from 1 January 2022. BACKGROUND The directive aims to strike a balance between a high level of consumer protection and increased business competitiveness, while respecting the principle of subsidiarity. It forms part of the digital single market strategy which provides a wide-ranging framework to encourage integration of the digital dimension into the internal market. The legislation complements Directive (EU) 2019/770 which lays down rules on the supply of digital content and digital services, including digital content supplied on a physical medium (such as DVDs, CDs, USB sticks and memory cards). For more information, see: Digital contracts rules (European Commission). KEY TERMS Sales contract: a contract where the seller transfers ownership of goods to a consumer in exchange for a price. Goods:any physical movable items, including water, gas and electricity when sold in a limited volume or a set quantity;any physical movable items that incorporate or are inter-connected with digital content or a digital service in such a way that the absence of that digital content or digital service would prevent the goods from performing their functions (‘goods with digital elements’). Digital content: data produced and supplied in digital form. Digital service:a service that allows the consumer to create, process, store or access data in digital form, ora service that allows the sharing of or other interaction with data in digital form uploaded or created by the consumer or other users of that service. MAIN DOCUMENT Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC (OJ L 136, 22.5.2019, pp. 28-50) RELATED DOCUMENTS Directive (EU) 2019/770 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the supply of digital content and digital services (OJ L 136, 22.5.2019, pp. 1-27) Regulation (EU) 2017/1128 of the European Parliament and of the Council of 14 June 2017 on cross-border portability of online content services in the internal market (OJ L 168, 30.6.2017, pp. 1-11) Successive amendments to Regulation (EU) 2017/1128 have been incorporated into the original document. This consolidated version is of documentary value only. Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees (OJ L 171, 7.7.1999, pp. 12-16) See consolidated version. last update 10.09.2019

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7.12.2018 EN Official Journal of the European Union L 312/1 REGULATION (EU) 2018/1860 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 79(2)(c) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) The return of third-country nationals who do not fulfil or no longer fulfil the conditions for entry, stay or residence in the Member States, in full respect of fundamental rights and in particular the principle of non-refoulement, and in accordance with Directive 2008/115/EC of the European Parliament and of the Council (2), is an essential part of the comprehensive efforts to tackle irregular migration and increase the rate of return of irregular migrants. (2) It is necessary to increase the effectiveness of the Union system to return illegally staying third-country nationals. This is essential for maintaining public trust in the Union migration and asylum policy and providing support to persons in need of international protection. (3) Member States should take all necessary measures to return illegally staying third-country nationals in an effective and proportionate manner, in accordance with the provisions of Directive 2008/115/EC. (4) Regulation (EU) 2018/1861 (3) and Regulation (EU) 2018/1862 (4) of the European Parliament and of the Council lay down the conditions for the establishment, operation and use of the Schengen Information System (SIS). (5) A system should be established for sharing information between Member States that use SIS pursuant to Regulation (EU) 2018/1861 concerning return decisions issued in respect of third-country nationals staying illegally on the territory of the Member States and for monitoring whether third-country nationals subject to those decisions have left the territory of the Member States. (6) This Regulation does not affect the rights and obligations of third-country nationals laid down in Directive 2008/115/EC. An alert entered into SIS for the purpose of return does not, in itself, constitute a determination of the status of the third-country national on the territory of Member States, especially in Member States other than the Member State which entered the alert into SIS. (7) Alerts on return entered into SIS and the exchange of supplementary information concerning those alerts should support competent authorities to take the necessary measures to enforce return decisions. SIS should contribute to the identification of and the information sharing between Member States on third-country nationals who are subject to such a return decision, who have absconded and are apprehended in another Member State. Those measures should help prevent and deter irregular migration and secondary movements and enhance cooperation between Member States' authorities. (8) To ensure the effectiveness of return and increase the added value of alerts on return, Member States should enter alerts into SIS in relation to return decisions they issue in respect of illegally staying third-country nationals in accordance with provisions respecting Directive 2008/115/EC. For this purpose, Member States should also enter an alert into SIS when decisions imposing or stating an obligation to return are issued in the situations described in Article 2(2) of that Directive, namely to third-country nationals who are subject to a refusal of entry in accordance with Regulation (EU) 2016/399 of the European Parliament and of the Council (5), or who are apprehended or intercepted by the competent authorities in connection with the irregular crossing by land, sea or air of the external border of a Member State and who have not subsequently obtained an authorisation or a right to stay in that Member State, and to third-country nationals who are subject to return as a criminal law sanction or as a consequence of a criminal law sanction, according to national law, or who are the subject of extradition procedures. In certain circumstances, Member States may refrain from entering alerts on return into SIS where the risk of the return decision not being complied with is low, namely during any period of detention or when the return decision is issued at the external border and is executed immediately, in order to reduce their administrative burden. (9) This Regulation should set out common rules for entering alerts on return into SIS. Alerts on return should be entered into SIS as soon as the underlying return decisions are issued. The alert should indicate whether a period for voluntary departure has been granted to the third-country national concerned, including whether such period has been extended and whether the decision has been suspended or removal has been postponed. (10) It is necessary to determine the categories of data to be entered into SIS in respect of a third-country national who is the subject of a return decision. Alerts on return should contain only those data that are necessary to identify the data subjects, to allow the competent authorities to take informed decisions without losing time and to ensure, where necessary, the protection of those authorities from persons who are, for example, armed, violent, have escaped or are involved in an activity as referred to in Articles 3 to 14 of Directive (EU) 2017/541 of the European Parliament and of the Council (6). Furthermore, in order to facilitate identification and detect multiple identities, the alert should include also a reference to the identification document of the person concerned and a copy of that document, where available. (11) Given the reliability of identifying persons using fingerprints and photographs or facial images, they should always be inserted in alerts on return. As they may not be available, for example, when a return decision is taken in absentia, it should exceptionally be possible to derogate from this requirement in such cases. (12) The exchange of supplementary information provided by the national competent authorities on third-country nationals subject to alerts on return, should always be carried out through the network of national offices called SIRENE Bureaux serving as point of contact and in accordance with Articles 7 and 8 of Regulation (EU) 2018/1861. (13) Procedures should be established to enable Member States to verify that the obligation to return has been complied with and to confirm the departure of the third-country national concerned to the Member State that entered the alert on return into SIS. This information should contribute to more comprehensive monitoring of the compliance with return decisions. (14) Alerts on return should be deleted as soon as the Member State or competent authority that issued the return decision receives confirmation that the return has taken place or where the competent authority has sufficient and convincing information that the third-country national has left the territory of the Member States. Where a return decision is accompanied by an entry ban, an alert for refusal of entry and stay should be entered into SIS in accordance with Regulation (EU) 2018/1861. In such cases Member States should take all necessary measures to ensure that no time-gap exists between the moment in which the third-country national leaves the Schengen area and the activation of the alert for refusal of entry and stay in SIS. If the data contained in SIS show that the return decision is accompanied by an entry ban, the enforcement of the entry ban should be ensured. (15) SIS should contain a mechanism for notifying the Member States of the non-compliance of third-country nationals with an obligation to return within a given period of voluntary departure. The mechanism should support the Member States in fulfilling their obligations to enforce return decisions and their obligations to issue an entry ban in accordance with Directive 2008/115/EC with regard to third-country nationals who have not complied with an obligation to return. (16) This Regulation should establish mandatory rules for consultation between Member States to avoid or reconcile conflicting instructions. Consultations should be carried out where third-country nationals who hold, or are being granted, a valid residence permit or a long-stay visa by a Member State are subject to an alert on return issued by another Member State, in particular if the return decision is accompanied by an entry ban, or where conflicting situations may arise at entry in the territories of the Member States. (17) Alerts should be kept in SIS only for the time required to fulfil the purposes for which they were entered. The relevant provisions of Regulation (EU) 2018/1861 on review periods should apply. Alerts on return should be automatically deleted as soon as they expire, in accordance with the review procedure referred to in that Regulation. (18) Personal data obtained by a Member State pursuant to this Regulation should not be transferred or made available to any third country. As a derogation to that rule, it should be possible to transfer such personal data to a third country where the transfer is subject to strict conditions and is necessary in individual cases in order to assist with the identification of a third-country national for the purposes of his or her return. The transfer of any personal data to third countries should be carried out in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (7) and be conducted with the agreement of the issuing Member State. It should be noted however, that third countries of return are often not subject to adequacy decisions adopted by the Commission under Article 45 of Regulation (EU) 2016/679. Furthermore, the extensive efforts of the Union in cooperating with the main countries of origin of illegally-staying third-country nationals subject to an obligation to return has not been able to ensure the systematic fulfilment by such third countries of the obligation established by international law to readmit their own nationals. Readmission agreements that have been concluded or are being negotiated by the Union or the Member States and which provide for appropriate safeguards for the transfer of data to third countries pursuant to Article 46 of Regulation (EU) 2016/679 cover a limited number of such third countries. Conclusion of any new agreement remains uncertain. In those circumstances, and as an exception to the requirement for an adequacy decision or appropriate safeguards, transfer of personal data to third-country authorities pursuant to this Regulation should be allowed for the purposes of implementing the return policy of the Union. It should be possible to use the derogation provided for in Article 49 of Regulation (EU) 2016/679, subject to the conditions set out in that Article. Under Article 57 of that Regulation, implementation of that Regulation, including with regard to transfers of personal data to third countries pursuant to this Regulation, should be subject to monitoring by independent supervisory authorities. (19) National authorities responsible for return might differ significantly among Member States, and such authorities might also vary within a Member State depending on the reasons for illegal stay. Judicial authorities might also issue return decisions, for instance as result of appeals against a refusal to grant an authorisation or right to stay or as a criminal sanction. All national authorities in charge of issuing and enforcing return decisions in accordance with Directive 2008/115/EC should be entitled to access SIS in order to enter, update, delete and search alerts on return. (20) Access to alerts on return should be granted to the national competent authorities referred to in Regulation (EU) 2018/1861 for the purpose of identification and return of third-country nationals. (21) Regulation (EU) 2016/794 of the European Parliament and of the Council (8) provides that Europol is to support and strengthen actions carried out by the national competent authorities and their cooperation in combating terrorism and serious crime and to provide analysis and threat assessments. In order to facilitate Europol in carrying out its tasks, in particular within the European Migrant Smuggling Centre, it is appropriate to allow Europol access to the category of alerts as provided for in this Regulation. (22) Regulation (EU) 2016/1624 of the European Parliament and of the Council (9) provides, for the purpose of that Regulation, that the host Member State is to authorise the members of the teams referred to in point (8) of Article 2 of that Regulation deployed by the European Border and Coast Guard Agency to consult Union databases where this consultation is necessary for fulfilling operational aims specified in the operational plan on border checks, border surveillance and return. The objective of the deployment of the teams referred to in points (8) and (9) of Article 2 of that Regulation is to provide technical and operational reinforcement to the requesting Member States, especially to those facing disproportionate migratory challenges. For the teams referred to in points (8) and (9) of Article 2 of that Regulation to fulfil their tasks, they require access to alerts on return in SIS through a technical interface of the European Border and Coast Guard Agency connecting to Central SIS. (23) The provisions on responsibilities of the Member States and the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice established by Regulation (EU) 2018/1726 of the European Parliament and of the Council (10) (‘eu-LISA’), on the entry and processing of alerts, on the conditions for access to and retention of alerts, on data processing, on data protection, on liability and on monitoring and statistics in Regulation (EU) 2018/1861 should also apply to data contained and processed in SIS in accordance with this Regulation. (24) Since the objectives of this Regulation, namely to establish a system for sharing information about return decisions issued by the Member States in accordance with provisions respecting Directive 2008/115/EC in view of facilitating their enforcement and to monitor the compliance of illegally staying third-country nationals with their obligation to return, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (25) This Regulation respects fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union. (26) The application of this Regulation is without prejudice to the obligations deriving from the Geneva Convention relating to the Status of Refugees of 28 July 1951, as supplemented by the New York Protocol of 31 January 1967. (27) Member States should implement this Regulation in full respect of fundamental rights, including the respect of the principle of non-refoulement, and should always take into consideration the best interests of the child, family life, and the state of health or condition of vulnerability of the individuals concerned. (28) In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark annexed to the TEU and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. Given that this Regulation builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Regulation whether it will implement it in its national law. (29) This Regulation constitutes a development of provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (11); the United Kingdom is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (30) This Regulation constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (12); Ireland is therefore not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (31) As regards Iceland and Norway, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters' association with the implementation, application and development of the Schengen acquis (13), which fall within the area referred to in Article 1, point (C) of Council Decision 1999/437/EC (14). (32) As regards Switzerland, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (15), which fall within the area referred to in Article 1, point (C) of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (16). (33) As regards Liechtenstein, this Regulation constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (17), which fall within the area referred to in Article 1, point (C) of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (18). (34) As regards Bulgaria and Romania, this Regulation constitutes an act building upon, or otherwise relating to, the Schengen acquis within the meaning of Article 4(2) of the 2005 Act of Accession and should be read in conjunction with Council Decisions 2010/365/EU (19) and (EU) 2018/934 (20). (35) As regards Croatia, this Regulation constitutes an act building upon, or otherwise relating to, the Schengen acquis within the meaning of Article 4(2) of the 2011 Act of Accession and should be read in conjunction with Council Decision (EU) 2017/733 (21). (36) Concerning Cyprus this Regulation constitutes an act building upon, or otherwise relating to, the Schengen acquis within the meaning of Article 3(2) of the 2003 Act of Accession. (37) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (22) and delivered an opinion on 3 May 2017, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter and scope This Regulation lays down the conditions and procedures for the entry and processing of alerts in respect of third-country nationals subject to return decisions issued by the Member States in the Schengen Information System (SIS) established by Regulation (EU) 2018/1861, as well as for exchanging supplementary information on such alerts. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘return’ means return as defined in point (3) of Article 3 of Directive 2008/115/EC; (2) ‘third-country national’ means a third-country national as defined in point (1) of Article 3 of Directive 2008/115/EC; (3) ‘return decision’ means an administrative or judicial decision or act, stating or declaring the stay of a third-country national to be illegal and imposing or stating an obligation to return that respects Directive 2008/115/EC; (4) ‘alert’ means an alert as defined in point (1) of Article 3 of Regulation (EU) 2018/1861; (5) ‘supplementary information’ means supplementary information as defined in point (2) of Article 3 of Regulation (EU) 2018/1861; (6) ‘removal’ means removal as defined in point (5) of Article 3 of Directive 2008/115/EC; (7) ‘voluntary departure’ means a voluntary departure as defined in point (8) of Article 3 of Directive 2008/115/EC; (8) ‘issuing Member State’ means an issuing Member State as defined in point (10) of Article 3 of Regulation (EU) 2018/1861; (9) ‘granting Member State’ means a granting Member State as defined in point (11) of Article 3 of Regulation (EU) 2018/1861; (10) ‘executing Member State’ means an executing Member State as defined in point (12) of Article 3 of Regulation (EU) 2018/1861; (11) ‘personal data’ means personal data as defined in point (1) of Article 4 of Regulation (EU) 2016/679; (12) ‘CS-SIS’ means the technical support function of the Central SIS as referred to in point (a) of Article 4(1) of Regulation (EU) 2018/1861; (13) ‘residence permit’ means a residence permit as defined in point (16) of Article 2 of Regulation (EU) 2016/399; (14) ‘long-stay visa’ means a long-stay visa as referred to in Article 18(1) of Convention of 19 June 1990 implementing the Schengen Agreement of 14 June 1985 between the governments of the States of the Benelux Economic Union, the Federal Republic of Germany and the French Republic on the gradual abolition of checks at their common borders (23); (15) a ‘hit’ means a hit as defined in point (8) of Article 3 of Regulation (EU) 2018/1861; (16) ‘threat to public health’ means a threat to public health as defined in point (21) of Article 2 of Regulation (EU) 2016/399; (17) ‘external borders’ means the external borders as defined in point (2) of Article 2 of Regulation (EU) 2016/399. Article 3 Entry of alerts on return into SIS 1. Member States shall enter into SIS alerts on third-country nationals subject to a return decision for the purpose of verifying that the obligation to return has been complied with and of supporting the enforcement of the return decisions. An alert on return shall be entered into SIS without delay following issue of a return decision. 2. Member States may refrain from entering alerts on return when the return decisions concern third-country nationals who are detained pending removal. If the third-country nationals concerned are released from detention without being removed, an alert on return shall be entered into SIS without delay. 3. Member States may refrain from entering alerts on return when the return decision is issued at the external border of a Member State and is executed immediately. 4. The period for voluntary departure granted in accordance with Article 7 of Directive 2008/115/EC shall be recorded in the alert on return immediately. Any extension of that period shall be recorded in the alert without delay. 5. Any suspension or postponement of the enforcement of the return decision, including as a result of the lodging of an appeal, shall immediately be recorded in the alert on return. Article 4 Categories of data 1. An alert on return entered into SIS in accordance with Article 3 of this Regulation shall contain only the following data: (a) surnames; (b) forenames; (c) names at birth; (d) previously used names and aliases; (e) place of birth; (f) date of birth; (g) gender; (h) any nationalities held; (i) whether the person concerned: (i) is armed; (ii) is violent; (iii) has absconded or escaped; (iv) poses a risk of suicide; (v) poses a threat to public health; or (vi) is involved in an activity referred to in Articles 3 to 14 of Directive (EU) 2017/541; (j) the reason for the alert; (k) the authority which created the alert; (l) a reference to the decision giving rise to the alert; (m) the action to be taken in the case of a hit; (n) links to other alerts pursuant to Article 48 of Regulation (EU) 2018/1861; (o) whether the return decision is issued in relation to a third-country national who poses a threat to public policy, to public security or to national security; (p) the type of offence; (q) the category of the person's identification documents; (r) the country of issue of the person's identification documents; (s) the number(s) of the person's identification documents; (t) the date of issue of the person's identification documents; (u) photographs and facial images; (v) dactyloscopic data; (w) a copy of the identification documents, in colour wherever possible; (x) last date of the period for voluntary departure, if granted; (y) whether the return decision has been suspended or the enforcement of the decision has been postponed, including as a result of the lodging of an appeal; (z) whether the return decision is accompanied by an entry ban constituting the basis for an alert for refusal of entry and stay pursuant to point (b) of Article 24(1) of Regulation (EU) 2018/1861. 2. The minimum set of data necessary to enter an alert into SIS shall be the data referred to in points (a), (f), (j), (l), (m), (x) and (z) of paragraph 1. The other data referred to in that paragraph shall also be entered into SIS, if available. 3. Dactyloscopic data referred to in point (v) of paragraph 1 may consist of: (a) one to ten flat fingerprints and one to ten rolled fingerprints of the third-country national concerned; (b) up to two palm prints in respect of third-country nationals from whom the collection of fingerprints is impossible; (c) up to two palm prints in respect of third-country nationals who are subject to return as a criminal law sanction or who have committed a criminal offence on the territory of the Member State which issued the return decision. Article 5 Authority responsible for the exchange of supplementary information The SIRENE Bureau designated under Article 7 of Regulation (EU) 2018/1861 shall ensure the exchange of all supplementary information on third-country nationals who are the subject of an alert on return, in accordance with Articles 7 and 8 of that Regulation. Article 6 Hits at the external borders at exit — Confirmation of return 1. In the event of a hit on an alert on return concerning a third-country national who is exiting the territory of the Member States through the external border of a Member State, the executing Member State shall communicate the following information to the issuing Member State through the exchange of supplementary information: (a) that the third-country national has been identified; (b) the location and time of the check; (c) that the third-country national has left the territory of the Member States; (d) that the third-country national has been subject to removal, if this is the case. Where a third-country national who is the subject of an alert on return exits the territory of the Member States through the external border of the issuing Member State, the confirmation of return shall be sent to the competent authority of that Member State in accordance with national procedures. 2. The issuing Member State shall delete the alert on return without delay following the receipt of the confirmation of return. Where applicable, an alert for refusal of entry and stay shall be entered without delay pursuant to point (b) of Article 24(1) of Regulation (EU) 2018/1861. 3. The Member States shall on a quarterly basis provide statistics to the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) on the number of confirmed returns and on the number of those confirmed returns where the third-country national was subject to removal. eu-LISA shall compile the quarterly statistics into the annual statistical report referred to in Article 16 of this Regulation. The statistics shall not contain personal data. Article 7 Non-compliance with return decisions 1. Upon expiry of the period for voluntary departure indicated in an alert on return, including any possible extensions, CS-SIS shall automatically notify the issuing Member State. 2. Without prejudice to the procedure referred to in Articles 6(1), 8 and 12, in the event of a hit on an alert on return, the executing Member State shall immediately contact the issuing Member State through the exchange of supplementary information in order to determine the measures to be taken. Article 8 Hits at the external borders upon entry In the event of a hit on an alert on return concerning a third-country national who is entering the territory of the Member States through the external borders, the following shall apply: (a) where the return decision is accompanied by an entry ban, the executing Member State shall immediately inform the issuing Member State through the exchange of supplementary information. The issuing Member State shall immediately delete the alert on return and enter an alert for refusal of entry and stay pursuant to point (b) of Article 24(1) of Regulation (EU) 2018/1861; (b) where the return decision is not accompanied by an entry ban, the executing Member State shall immediately inform the issuing Member State through the exchange of supplementary information, in order that the issuing Member State delete the alert on return without delay. The decision on the entry of the third-country national shall be taken by the executing Member State in accordance with Regulation (EU) 2016/399. Article 9 Prior consultation before granting or extending a residence permit or long-stay visa 1. Where a Member State considers granting or extending a residence permit or long-stay visa to a third-country national who is the subject of an alert on return entered by another Member State that is accompanied by an entry ban, the Member States involved shall consult each other through the exchange of supplementary information, in accordance with the following rules: (a) the granting Member State shall consult the issuing Member State prior to granting or extending the residence permit or long-stay visa; (b) the issuing Member State shall reply to the consultation request within 10 calendar days; (c) the absence of a reply by the deadline referred to in point (b) shall mean that the issuing Member State does not object to the granting or extending of the residence permit or long-stay visa; (d) when making the relevant decision, the granting Member State shall take into account the reasons for the decision of the issuing Member State and shall consider, in accordance with national law, any threat to public policy or to public security which the presence of the third-country national in question on the territory of the Member States may pose; (e) the granting Member State shall notify the issuing Member State of its decision; and (f) where the granting Member State notifies the issuing Member State that it intends to grant or extend the residence permit or long-stay visa or that it has decided to do so, the issuing Member State shall delete the alert on return. The final decision on whether to grant a residence permit or long-stay visa to a third-country national rests with the granting Member State. 2. Where a Member State considers granting or extending a residence permit or long-stay visa to a third-country national who is the subject of an alert on return entered by another Member State which is not accompanied by an entry ban, the granting Member State shall inform without delay the issuing Member State that it intends to grant or has granted a residence permit or a long-stay visa. The issuing Member State shall delete the alert on return without delay. Article 10 Prior consultation before entering an alert on return Where a Member State has issued a return decision in accordance with Article 6(2) of Directive 2008/115/EC and considers entering an alert on return concerning a third-country national who is the holder of a valid residence permit or long-stay visa granted by another Member State, the Member States involved shall consult each other, through the exchange of supplementary information, in accordance with the following rules: (a) the Member State that has taken the return decision shall inform the granting Member State of the decision; (b) the information exchanged under point (a) shall include sufficient detail on the reasons for the return decision; (c) on the basis of the information provided by the Member State that has taken the return decision, the granting Member State shall consider whether there are reasons for withdrawing the residence permit or long-stay visa; (d) when making the relevant decision, the granting Member State shall take into account the reasons for the decision of the Member State that has taken the return decision and shall consider, in accordance with national law, any threat to public policy or to public security which the presence of the third-country national in question on the territory of the Member States may pose; (e) within 14 calendar days of receipt of the request for consultation the granting Member State shall notify the Member State that has taken the return decision of its decision or, where it has been impossible for the granting Member State to take a decision within that period, shall make a reasoned request to extend exceptionally the time period for its response for a maximum of a further 12 calendar days; (f) where the granting Member State notifies the Member State that has taken the return decision that it is maintaining the residence permit or long-stay visa, the Member State that has taken the return decision shall not enter the alert on return. Article 11 A posteriori consultation after entering an alert on return Where it emerges that a Member State has entered an alert on return concerning a third-country national who is the holder of a valid residence permit or long-stay visa granted by another Member State, the issuing Member State may decide to withdraw the return decision. In the case of such withdrawal, it shall immediately delete the alert on return. However, where the issuing Member State decides to maintain the return decision issued in accordance with Article 6(2) of Directive 2008/115/EC, the Member States involved shall consult each other, through the exchange of supplementary information, in accordance with the following rules: (a) the issuing Member State shall inform the granting Member State of the return decision; (b) the information exchanged under point (a) shall include sufficient detail on the reasons for the alert on return; (c) on the basis of the information provided by the issuing Member State, the granting Member State shall consider whether there are reasons for withdrawing the residence permit or long-stay visa; (d) when making its decision, the granting Member State shall take into account the reasons for the decision of the issuing Member State and shall consider, in accordance with national law, any threat to public policy or to public security which the presence of the third-country national in question on the territory of the Member States may pose; (e) within 14 calendar days of receipt of the request for consultation the granting Member State shall notify the issuing Member State of its decision or, where it has been impossible for the granting Member State to take a decision within that period, shall make a reasoned request to extend exceptionally the time period for its response for a maximum of a further 12 calendar days; (f) where the granting Member State notifies the issuing Member State that it is maintaining the residence permit or long-stay visa, the issuing Member State shall immediately delete the alert on return. Article 12 Consultation in the case of a hit concerning a third-country national holding a valid residence permit or long-stay visa Where a Member State encounters a hit on an alert on return entered by a Member State concerning a third-country national who is the holder of a valid residence permit or long-stay visa granted by another Member State, the Member States involved shall consult each other through the exchange of supplementary information, in accordance with the following rules: (a) the executing Member State shall inform the issuing Member State of the situation; (b) the issuing Member State shall initiate the procedure laid down in Article 11; (c) the issuing Member State shall notify the executing Member State of the outcome following the consultation. Article 13 Statistics on exchange of information Member States shall provide statistics to eu-LISA on an annual basis on the exchanges of information carried out in accordance with Articles 8 to 12 and on the instances in which the deadlines provided for in those Articles were not met. Article 14 Deletion of alerts 1. In addition to Articles 6 and 8 to 12, alerts on return shall be deleted when the decision on the basis of which the alert was entered has been withdrawn or annulled by the competent authority. Alerts on return shall also be deleted when the third-country national concerned can demonstrate that he or she has left the territory of the Member States in compliance with the respective return decision. 2. Alerts on return concerning a person who has acquired citizenship of a Member State or of any State whose nationals are beneficiaries of the right of free movement under Union law shall be deleted as soon as the issuing Member State becomes aware, or is so informed pursuant to Article 44 of Regulation (EU) 2018/1861 that the person in question has acquired such citizenship. Article 15 Transfer of personal data to third countries for the purpose of return 1. By way of derogation from Article 50 of Regulation (EU) 2018/1861, the data referred to in points (a), (b), (c), (d), (e), (f), (g), (h), (q), (r), (s), (t), (u), (v) and (w) of Article 4(1) of this Regulation and the related supplementary information may be transferred or made available to a third country with the agreement of the issuing Member State. 2. The transfer of the data to a third country shall be carried out in accordance with the relevant provisions of Union law, in particular provisions on protection of personal data, including Chapter V of Regulation (EU) 2016/679, with readmission agreements where applicable, and with the national law of the Member State transferring the data. 3. The transfers of data to a third country shall take place only when the following conditions are met: (a) the data is transferred or made available solely for the purpose of identification of, and issuance of an identification or travel document to, an illegally staying third-country national in view of his or her return; (b) the third-country national concerned has been informed that his or her personal data and supplementary information may be shared with the authorities of a third country. 4. Transfers of personal data to third countries pursuant to this Article shall not prejudice the rights of applicants for and beneficiaries of international protection, in particular as regards non-refoulement, and the prohibition on disclosing or obtaining information set out in Article 30 of Directive 2013/32/EU of the European Parliament and of the Council (24). 5. Data processed in SIS and the related supplementary information exchanged pursuant to this Regulation shall not be made available to a third country where the enforcement of the return decision was suspended or postponed, including as a result of the lodging of an appeal, on grounds that such return would violate the principle of non-refoulement. 6. Application of Regulation (EU) 2016/679, including with regard to the transfer of personal data to third countries pursuant to this Article, and in particular the use, proportionality and necessity of transfers based on point (d) of Article 49(1) of that Regulation, shall be subject to monitoring by the independent supervisory authorities referred to in Article 51(1) of that Regulation. Article 16 Statistics eu-LISA shall produce daily, monthly and annual statistics, both for each Member State and in aggregate, on the number of alerts on return entered into SIS. The statistics shall include the data referred to in point (y) of Article 4(1), the number of notifications referred to in Article 7(1) and the number of alerts on return that have been deleted. eu-LISA shall produce statistics on the data provided by the Member States in accordance with Article 6(3) and Article 13. The statistics shall not contain any personal data. Those statistics shall be included in the annual statistical report provided for in Article 60(3) of Regulation (EU) 2018/1861. Article 17 Competent authorities having a right to access data in SIS 1. Access to data in SIS and the right to search such data shall be reserved to the national competent authorities referred to in Article 34(1), (2) and (3) of Regulation (EU) 2018/1861. 2. Europol shall within its mandate have the right to access and search data in SIS in accordance with Article 35 of Regulation (EU) 2018/1861 for the purpose of supporting and strengthening action by the competent authorities of the Member States and their mutual cooperation in preventing and combating migrant smuggling and facilitation of irregular migration. 3. Members of the teams referred to in points (8) and (9) of Article 2 of Regulation (EU) 2016/1624 shall within their mandate have the right to access and search data in SIS in accordance with Article 36 of Regulation (EU) 2018/1861 for the purpose of carrying out border checks, border surveillance and return operations through the technical interface set up and maintained by the European Border and Coast Guard Agency. Article 18 Evaluation The Commission shall evaluate the application of this Regulation within two years of the date of the start of its application. This evaluation shall include an assessment of the possible synergies between this Regulation and Regulation (EU) 2017/2226 of the European Parliament and of the Council (25). Article 19 Applicability of the provisions of Regulation (EU) 2018/1861 Insofar as not established in this Regulation, the entry, processing and updating of alerts, the provisions on responsibilities of the Member States and eu-LISA, the conditions concerning access and the review period for alerts, data processing, data protection, liability and monitoring and statistics, as laid down in Articles 6 to 19, Article 20(3) and (4), Articles 21, 23, 32, 33, 34(5) and 38 to 60 of Regulation (EU) 2018/1861, shall apply to data entered and processed in SIS in accordance with this Regulation. Article 20 Entry into force This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union. It shall apply from the date set by the Commission in accordance with Article 66(2) of Regulation (EU) 2018/1861. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Brussels, 28 November 2018. For the European Parliament The President A. TAJANI For the Council The President K. EDTSTADLER (1) Position of the European Parliament of 24 October 2018 (not yet published in the Official Journal) and decision of the Council of 19 November 2018. (2) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, p. 98). (3) Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (see page 14 of this Official Journal). (4) Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission Decision 2010/261/EU (see page 56 of this Official Journal). (5) Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1). (6) Directive (EU) 2017/541 of the European Parliament and of the Council of 15 March 2017 on combating terrorism and replacing Council Framework Decision 2002/475/JHA and amending Council Decision 2005/671/JHA (OJ L 88, 31.3.2017, p. 6). (7) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (8) Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA (OJ L 135, 24.5.2016, p. 53). (9) Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, p. 1). (10) Regulation (EU) 2018/1726 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA), and amending Regulation (EC) No 1987/2006 and Council Decision 2007/533/JHA and repealing Regulation (EU) No 1077/2011 (OJ L 295, 21.11.2018, p. 99). (11) Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43). (12) Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20). (13) OJ L 176, 10.7.1999, p. 36. (14) Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31). (15) OJ L 53, 27.2.2008, p. 52. (16) Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1). (17) OJ L 160, 18.6.2011, p. 21. (18) Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19). (19) Council Decision 2010/365/EU of 29 June 2010 on the application of the provisions of the Schengen acquis relating to the Schengen Information System in the Republic of Bulgaria and Romania (OJ L 166, 1.7.2010, p. 17). (20) Council Decision (EU) 2018/934 of 25 June 2018 on the putting into effect of the remaining provisions of the Schengen acquis relating to the Schengen Information System in the Republic of Bulgaria and Romania (OJ L 165, 2.7.2018, p. 37). (21) Council Decision (EU) 2017/733 of 25 April 2017 on the application of the provisions of the Schengen acquis relating to the Schengen Information System in the Republic of Croatia (OJ L 108, 26.4.2017, p. 31). (22) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (23) OJ L 239, 22.9.2000, p. 19. (24) Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60). (25) Regulation (EU) 2017/2226 of the European Parliament and of the Council of 30 November 2017 establishing an Entry/Exit System (EES) to register entry and exit data and refusal of entry data of third-country nationals crossing the external borders of the Member States and determining the conditions for access to the EES for law enforcement purposes, and amending the Convention implementing the Schengen Agreement and Regulations (EC) No 767/2008 and (EU) No 1077/2011 (OJ L 327, 9.12.2017, p. 20).

A strengthened Schengen Information System A strengthened Schengen Information System SUMMARY OF: Regulation (EU) 2018/1860 on the use of the Schengen Information System (SIS) for the return of illegally staying third-country nationals Regulation (EU) 2018/1861 on the establishment, operation and use of the SIS in the field of border checks, and amending the Convention implementing the Schengen Agreement Regulation (EU) 2018/1862 on the establishment, operation and use of the SIS in the field of police cooperation and judicial cooperation in criminal matters WHAT IS THE AIM OF THESE REGULATIONS? The Schengen Information System (SIS), created in 1995 following the abolition of internal border controls in the EU, is a large-scale database supporting external border control and law enforcement cooperation between member countries of the Schengen Agreement. The 3 regulations are designed to strengthen the existing measures in SIS II — established in 2006 and operational from 2013 — particularly in light of the new migration and security challenges. They will replace the current legislation laid down in Regulations (EC) No 1986/2006 and (EC) No 1987/2006, and Decision 2007/533/JHA. This summary describes how the SIS will operate once the 3 new regulations are fully in force. KEY POINTS Architecture SIS consists of: a central system (Central SIS) with a technical support function (CS-SIS), containing a database (SIS database) performing technical supervision and administrative tasks, and a backup CS-SIS;a uniform national interface (NI-SIS) in each country which members use to enter, update, delete and search SIS data;a national system (N.SIS) in each country to communicate with Central SIS, including at least one national or shared backup N.SIS. It is not possible to search data files in another N.SIS, unless the countries concerned have agreed to share the file; a communication infrastructure between CS-SIS, backup CS-SIS and NI-SIS provides an encrypted virtual network for SIS data and their exchange between SIRENE bureaux. The European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA): implements technical solutions to strengthen the uninterrupted availability of SIS; in exceptional circumstances, may develop an additional copy of the SIS database; must present a report no later than 28 December 2019 on options for technical solutions, containing an independent impact assessment and cost-benefit analysis; publishes a list of the N.SIS offices and SIRENE Bureaux. Procedural rules state: alerts* should remain in SIS only as long as required for their specific purpose and be deleted when they achieve their purpose; alerts must be reviewed within defined periods. The member country may then decide to prolong them, otherwise they are automatically deleted. The review periods are 5 years: persons wanted for arrest for surrender or extradition purposes and missing persons who may, or may not, need to be placed under protection3 years: people sought to assist with a judicial procedure and unknown wanted persons1 year: children at risk, vulnerable persons who need to be protected from travelling and persons for discreet, inquiry or specific checks10 years: objects for discreet inquiry or specific checks or for seizure or use as evidence in criminal proceedings; categories of data to be entered into the system. These are designed to help end-users take decisions quickly. They include minimum requirements (surname, date of birth, reason for the alert and action to be taken) and other data, such as type of offence, photographic and dactyloscopic* information, if available; use of biometric and dactyloscopic data must respect EU law and fundamental rights, and meet minimum quality standards and technical specifications; a case must be adequate, relevant and sufficiently important to warrant an SIS alert, for example, an alert linked to a terrorist offence meets these criteria; only the issuing member country may modify, add to, correct, update or delete data in SIS; a country which considers acting on an alert would be incompatible with its national law, international obligations or essential interests may attach a flag* to the alert. This indicates it will not take any action on its territory. Costs: the EU budget covers the operational, maintenance and development costs of Central SIS and the communication infrastructure; Schengen member countries cover the operational, maintenance and development costs of their own N.SIS. Alert categories per regulation Regulation (EU) 2018/1860 strengthens enforcement of the EU’s return policy and reduces incentives for illegal immigration into the EU: it lays down common conditions and procedures for entering and processing alerts and exchanging supplementary information on non-EU nationals subject to return decisions*; it requires national authorities to enter alerts as soon as a return decision is taken; it establishes harmonised procedures on categories of data to be included in the alertverification if a return decision has been complied with and, if not, the follow-up between the relevant authoritiesretention and deletion of alerts to ensure there is no delay between the departure of a non-EU national and the activation of an entry bancompulsory consultation between national authorities before granting or extending a residence permit or long-stay visa for a non-EU national who may be the subject of a return alert in another EU countryentering an alert on a return decision if the person is legally staying elsewhere in the EU. Regulation (EU) 2018/1861 covers the use of SIS for entry bans and border checks: it establishes the conditions and procedures for entering and processing alerts and exchange of supplementary information* on non-EU nationals refused entry or the right to stay in the EU; it introduces harmonised procedures on categories of data to be included in the alertcompulsory entry of an alert when a non-EU national is refused entry or the right to stay because they pose a security threat or are subject to a restrictive order preventing entry into, or transit through, an EU countrynon-EU nationals with the right of free movement within the EUmandatory consultation between national authorities before granting or extending a residence permit or long-stay visa to a non-EU national refused the right of entry or stay in another EU country; it guarantees non-EU nationals the right to be informed in writing if they are the subject of an alert. Regulation 2018/1862 improves and extends the use of SIS for cooperation between police and judicial authorities: it establishes the conditions and procedures for entering and processing alerts in the SIS on people and objects, and for exchanging supplementary information and data in police and judicial cooperation on criminal matters; it covers procedures on alerts on: people wanted for arrest, for surrender or extradition purposes;missing persons;vulnerable persons who need to be prevented from travelling, either for their own protection or to prevent a threat to public order or security;children at risk, notably of abduction, trafficking or becoming involved in terrorism;individuals being sought to assist with a judicial procedure as witnesses or because they have been summoned in connection with criminal proceedings;unknown wanted persons whose identity is being sought;discreet or specific checks and inquiries to prevent, detect, investigate or prosecute criminal offences, execute a criminal sentence or prevent threats to public security;items to be seized or used as evidence in criminal proceedings, especially readily identifiable objects such as cars, boats, aircraft, firearms, identity documents and banknotes. Data rightsIndividuals have the right to: know whether or not their personal data are being processed, for what purposes and under what conditions; lodge a complaint with a supervisory authority; correction of inaccurate personal data without undue delay; erasure of personal data if their use is no longer necessary or these have been unlawfully processed; take action to access, rectify, erase, obtain information or compensation for an alert that concerns them; compensation from a member country for any material or non-material damage they suffer from unlawful processing of their personal data. SIS member governments: are committed to enforcing rulings on data protection rights; report annually to the European Data Protection Board on the number of requests they receive to access data and correct inaccuracies, and the volume of court cases and their outcome. Independent supervisory authorities monitor the legality of national processing of personal data in SIS; the European Data Protection Supervisor set up under Regulation (EU) 2018/1725 performs the same role for eu-LISA. The two cooperate to ensure coordinated supervision of SIS. Data processed in SIS and related supplementary information may not be transferred or made available to non-EU countries or international organisations. Regulation (EU) 2018/1725 applies to personal data processed by eu-LISA, the European Border and Coast Guard Agency and Eurojust. Regulation (EU) 2016/679 and Directive (EU) 2016/680 apply to personal data processed by national competent authorities and services. The following have access to data in SIS: National authorities responsible for border control, police and customs checks;prevention, detection, investigation or prosecution of terrorist acts or other serious criminal offences;decisions, including on residence permits and long-stay visas, on the entry, stay and return of non-EU nationals;security checks on non-EU nationals applying for international protection;naturalisation decisions;public prosecutions in criminal proceedings and judicial inquiries;issuing registration certificates for vehicles, boats, aircraft and firearms; the EU agencies below have the right to access and search for the data in SIS they require to carry out their responsibilities. They inform the issuing member country when a search reveals the existence of an alert. They may not connect parts of SIS or transfer any of its data to their own system Europol: may access all data, not just some as previously. SIS member countries must inform the law enforcement agency of any hits or alerts relating to terrorist offences;Eurojust, which handles judicial cooperation of criminal matters;European Border and Coast Guard, teams involved in return-related tasks and migration management support teams. The European Commission evaluates every 5 years the use these agencies make of SIS. ResponsibilitiesEach SIS member country: ensures the data are accurate, up-to-date and entered and stored in SIS lawfully, and respect general data processing rules; sets up, operates, maintains and develops its N.SIS, according to common standards, protocols and technical procedures, and connects it to NI-SIS; ensures the uninterrupted availability of SIS data to end-users; transmits its alerts through its N.SIS; designates an N.SIS Office with central responsibility to ensure the smooth operation and security of its N.SIS, access of the competent authorities to the SIS, overall compliance with the regulation and appropriate availability of the SIS for all end-users; appoints a national authority (the SIRENE Bureau) as a single contact point operational 24/7 for the exchange and availability of all supplementary information on alerts and to facilitate follow-up action; adopts security, business continuity and disaster recovery plans to protect data and prevent unauthorised access; applies professional secrecy and confidentiality rules, including close monitoring of external contractors. Private companies and organisations are banned from operational management of the N.SIS; keeps electronic logs, normally deleted after 3 years, on alerts, access and exchange of personal data to check whether the search was lawful and ensure data integrity and security; operates a national SIS training programme for staff with access to SIS on data security, fundamental rights, including data protection, and data processing rules and regulations. The Commission: adopts implementing and delegated acts on technical aspects of SIS and updates these as necessary; under Regulation (EU) No 1053/2013, has an overall coordinating role for the evaluation and monitoring mechanism it implements with EU governments to ensure Schengen rules are fully applied nationally. This includes evaluation of the SIS; will submit a report to the European Parliament and EU governments by 28 December 2019, and every year thereafter, until decides on the date for SIS operations to start, on the state of play of preparations for full implementation of the updated SIS regulation 2018/1862; carries out an overall evaluation of Central SIS, the supplementary information exchange between national authorities, including an assessment of the automated fingerprint identification system (AFIS) and the SIS information campaigns 3 years after the regulation comes into force and every 4 years thereafter. eu-LISA is responsible for: Central SIS: its operational management, including quality checks on the data it contains, and all the tasks necessary to ensure it functions 24/7 every day of the year; communication infrastructure: key aspects, notably supervision, security, coordination between member countries and providers, and budgetary and contractual issues; SIRENE Bureaux: coordinating, managing and supporting testing activities, maintaining and updating technical specifications on supplementary information exchange between the Bureaux and the communication infrastructure, and managing technical change; adopting the necessary measures to protect data and prevent unauthorised access or use, including security, business continuity and disaster recovery plans for Central SIS and the communication infrastructure; applying professional secrecy and confidentiality rules, and maintenance of electronic logs on the same conditions as national authorities; making publicly available via the EU’s Official Journal a list of national authorities authorised to search for data in SIS; producing daily, monthly and annual statistics on the number of records per category of alerts, omitting any personal data. Its reports are made public. Information campaign The Commission, in cooperation with supervisory authorities and the European Data Protection Supervisor, runs the campaign. This is launched when the legislation comes into force and is repeated at regular intervals, to inform the public on: the aims of SIS;the data it holds;the authorities with access to it;individuals’ data rights. The Commission maintains a publicly available website with all relevant information on SIS. EU countries, working with their supervisory authorities, must inform the public about SIS. FROM WHEN DO THE REGULATIONS APPLY? They shall apply gradually and in entirety they shall be fully operational byno later than 28 December 2021. The date is to be decided by the Commission after the verification that the following conditions have been met: implementing acts have been adopted; national authorities have made the necessary arrangements to process SIS data and the exchange of supplementary information; eu-LISA has successfully completed all its testing requirements. BACKGROUND While based on different pieces of legislation, the SIS is a single system for sharing data and requests among its members. It is the most widely used and largest security and border management information sharing system in Europe. In 2018, it contained some 82.2 million records, had been accessed more than 6.1 billion times and secured 267,239 hits. It operates in 30 European countries: all EU members apart from Cyprus and Ireland, and in Iceland, Liechtenstein, Norway and Switzerland. Communication from the Commission — COVID-19 Guidance on the implementation of the temporary restriction on non-essential travel to the EU, on the facilitation of transit arrangements for the repatriation of EU citizens, and on the effects on visa policy KEY TERMS Alert: a set of data enabling authorities to identify a person or object and act accordingly. Dactyloscopic data: data on palm and fingerprints. Flag: suspension of the validity of an alert at national level. Return decisions: judicial or administrative decision on a non-EU national considered to be staying illegally who should return to their home country. Supplementary information: information not forming part of the alert data in SIS, but connected to it. MAIN DOCUMENTS Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals(OJ L 312, 7.12.2018, pp. 1-13) Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (OJ L 312, 7.12.2018, pp. 14-55) Successive amendments to Regulation (EU) 2018/1861 have been incorporated into the original document. This consolidated version is of documentary value only. Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission Decision 2010/261/EU (OJ L 312, 7.12.2018, pp. 56-106) See consolidated version. RELATED DOCUMENTS Regulation (EU) 2018/1726 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA), and amending Regulation (EC) No 1987/2006 and Council Decision 2007/533/JHA and repealing Regulation (EU) No 1077/2011 (OJ L 295, 21.11.2018, pp. 99-137) Directive (EU) 2017/541 of the European Parliament and of the Council of 15 March 2017 on combating terrorism and replacing Council Framework Decision 2002/475/JHA and amending Council Decision 2005/671/JHA (OJ L 88, 31.3.2017, pp. 6-21) Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, pp. 1-76) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1-88) See consolidated version. Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, pp. 1-52) See consolidated version. Council Regulation (EU) No 1053/2013 of 7 October 2013 establishing an evaluation and monitoring mechanism to verify the application of the Schengen acquis and repealing the Decision of the Executive Committee of 16 September 1998 setting up a Standing Committee on the evaluation and implementation of Schengen (OJ L 295, 6.11.2013, pp. 27-37) Directive 2008/115/EC of the European Parliament and of the Council of 16 December 2008 on common standards and procedures in Member States for returning illegally staying third-country nationals (OJ L 348, 24.12.2008, pp. 98-107) The Schengen acquis as referred to in Article 1(2) of Council Decision 1999/435/EC of 20 May 1999 (OJ L 239, 22.9.2000, pp. 1-473) last update 04.05.2020

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25.7.2019 EN Official Journal of the European Union L 198/64 REGULATION (EU) 2019/1239 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 establishing a European Maritime Single Window environment and repealing Directive 2010/65/EU THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 100(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Directive 2010/65/EU of the European Parliament and of the Council (3) requires Member States to accept the fulfilment of the reporting obligations of ships arriving in and departing from Union ports in electronic format and to ensure their transmission via a single window in order to facilitate and expedite maritime transport. (2) Maritime transport is the backbone of trade and communications within and beyond the single market. For the facilitation of maritime transport, and in order to further reduce the administrative burden for shipping companies, the information procedures for fulfilment of reporting obligations imposed on shipping companies by Union legal acts, by international legal acts and by national law of Member States should be further simplified and harmonised and should be technology-neutral, promoting future-proof reporting solutions. (3) Both the European Parliament and the Council have frequently called for more interoperability and for more comprehensive, user-friendly communication and information flows, in order to improve the functioning of the internal market and to meet the needs of citizens and businesses. (4) The main aim of this Regulation is to lay down harmonised rules for the provision of the information that is required for port calls, in particular by ensuring that the same data sets can be reported to each maritime National Single Window in the same way. This Regulation also aims to facilitate the transmission of information between declarants, relevant authorities and the providers of port services in the port of call, and other Member States. The application of this Regulation should not alter the time frames for, or the substance of, reporting obligations, and should not affect the subsequent storage and processing of information at Union level or at national level. (5) The existing maritime National Single Window in each Member State should be maintained as the basis for a technologically neutral and interoperable European Maritime Single Window environment (‘EMSWe’). The maritime National Single Window should constitute a comprehensive reporting entry point for maritime transport operators, performing the functionalities of data collection from the declarants and data distribution to all relevant competent authorities and providers of port services. (6) In order to enhance the efficiency of the maritime National Single Windows and to prepare for future developments, it should be possible to maintain present or establish new arrangements in Member States to use the maritime National Single Window for the reporting of similar information for other transport modes. (7) The front-end interfaces of those maritime National Single Windows on the side of the declarants should be harmonised at Union level, in order to facilitate reporting and further reduce administrative burden. This harmonisation should be achieved by the use in every maritime National Single Window of common interface software for system-to-system exchanges of information, developed at Union level. The Member States should bear the responsibility for integrating and managing the interface module and for updating the software regularly and in a timely manner when new versions are provided by the Commission. The Commission should develop this module and provide updates when needed, since the development of digital technologies is moving fast and any technological solution could rapidly become outdated in the light of new developments. (8) Other reporting channels provided by Member States and service providers, such as Port Community Systems, could be maintained as optional entry points for reporting and should be able to act as data service providers. (9) In order not to impose a disproportionate administrative burden on landlocked Member States which do not have maritime ports, such Member States should be exempted from the obligation to develop, establish, operate and make available a maritime National Single Window. This means that, for as long as they make use of this exemption, such Member States should not be required to fulfil obligations that are linked to the development, establishment, operation and making available of a maritime National Single Window. (10) An easy-to-use graphical user interface with common functionalities should be part of the maritime National Single Windows for manual reporting by declarants. Member States should offer the graphical user interface for manual entry of data by declarants also by way of uploading harmonised digital spreadsheets. In addition to ensuring common functionalities, the Commission and Member States should coordinate efforts with the aim of ensuring that the user experience of those graphical user interfaces is as similar as possible. (11) Emerging new digital technologies present ever-growing opportunities to increase the efficiency of the maritime transport sector and to reduce administrative burdens. In order for the benefits of such new technologies to accrue as early as possible, the Commission should be empowered to amend the technical specifications, standards and procedures of the harmonised reporting environment by means of implementing acts. This should leave flexibility for market players to develop new digital technologies and new technologies should also be taken into account when this Regulation is reviewed. (12) Adequate support and information on the processes and technical requirements related to the use of maritime National Single Window should be provided to declarants via easily accessible and user-friendly national websites with common ‘look and feel’ standards. (13) The Convention on Facilitation of International Maritime Traffic (‘the FAL Convention’) (4) provides that public authorities must in all cases require only essential reporting information and keep the number of items to a minimum. However, local conditions may require specific information to ensure safety of navigation. (14) In order to enable the functioning of the EMSWe, it is necessary to establish a comprehensive EMSWe data set which should cover all information elements that might be requested by national authorities or port operators for administrative or operational purposes when a ship makes a port call. When establishing the EMSWe data set, the Commission should take into account relevant work carried out at international level. Since the scope of reporting obligations varies from one Member State to another, a maritime National Single Window in a given Member State should be designed to accept the EMSWe data set without any modification, and disregard any information not relevant for that Member State. (15) In exceptional circumstances, a Member State should be able to request additional data elements from declarants. Such exceptional circumstances may arise, for example, when there is an urgent need to protect internal order and security or to address a serious threat against human or animal health or against the environment. The notion of exceptional circumstances should be interpreted strictly. (16) The relevant reporting obligations contained in the Union and international legal acts should be listed in the Annex to this Regulation. Those reporting obligations should provide the basis for the establishment of the comprehensive EMSWe data set. The Annex should also refer to the relevant categories of reporting obligations at national level, and the Member States should be able to request the Commission to amend the EMSWe data set on the basis of reporting obligations contained in their national legislation and requirements. Union legal acts which amend the EMSWe data set on the basis of a reporting obligation contained in the national legislation and requirements should include explicit reference to that national legislation and requirements. (17) Whenever the information from the maritime National Single Window is distributed to the competent authorities, the transmission should comply with the common data requirements, formats and codes for the reporting obligations and formalities provided for in the Union legal acts listed in the Annex and should be made through the IT systems established therein, such as the electronic data-processing techniques referred to in Article 6(1) of Regulation (EU) No 952/2013 of the European Parliament and of the Council (5). (18) The implementation of this Regulation should take into account the SafeSeaNet systems established at national and Union level, which should continue to facilitate the exchange and distribution of information received through the maritime National Single Window between the Member States in accordance with Directive 2002/59/EC of the European Parliament and of the Council (6). (19) Ports are not the final destination of goods. The efficiency of the ship port calls have an impact on the entire logistics chain related to the transport of goods and passengers to and from the ports. In order to ensure the interoperability, multimodality, and smooth integration of maritime transport with the overall logistics chain, and in order to facilitate other transport modes, the maritime National Single Windows should allow for the possibility of exchanging relevant information, such as arrival and departure times, with similar frameworks developed for other transport modes. (20) In order to improve the efficiency of maritime transport and to limit the duplication of the information which must be provided for operational purposes when a ship makes a port call, the information provided by declarants to a maritime National Single Window should be also shared with certain other entities, such as port or terminal operators, when authorised by the declarant, and taking into account the need to respect confidentiality, commercial sensitivities and legal constraints. This Regulation aims to improve the handling of data following the once-only principle when fulfilling the reporting obligations. (21) Regulation (EU) No 952/2013 provides that goods which are brought into the customs territory of the Union must be covered by an entry summary declaration that must be submitted to the customs authorities electronically. Given the importance of the entry summary declaration information for the management of security and financial risks, a specific electronic system is currently being developed for the submission and management of entry summary declarations in the Union customs territory. It will not, therefore, be possible to submit entry summary declarations through the harmonised reporting interface module. However, considering that some of the data elements submitted in the entry summary declaration are also required for the fulfilment of other customs and maritime reporting obligations when a ship calls in a port of the Union, the EMSWe should be able to process the data elements of the entry summary declaration. The possibility that the maritime National Single Window could retrieve relevant information that has already been submitted through the entry summary declaration should also be envisaged. (22) In order to fully harmonise reporting requirements, customs, maritime and other relevant authorities should cooperate at both national and Union level. National coordinators with specific responsibilities should enhance the effectiveness of this cooperation and the smooth functioning of the maritime National Single Windows. (23) In order to enable the reuse of the information provided through the maritime National Single Windows and facilitate the submission of information by declarants, it is necessary to provide for common databases. An EMSWe ship database should be established which includes a reference list of ship particulars and their reporting exemptions, as reported to the respective maritime National Single Window. To facilitate the submission of information by declarants, a Common Location Database should be established which holds a reference list of location codes, including the United Nations Code for Trade and Transport Locations (UN/LOCODE), the SafeSeaNet-specific codes, and the port facility codes as registered in the Global Integrated Shipping Information System (GISIS) of the International Maritime Organization (IMO). Furthermore, a Common Hazmat Database should be established which incorporates a list of dangerous and polluting goods that are to be notified to the maritime National Single Window in accordance with Directive 2002/59/EC and IMO FAL 7, taking into consideration the relevant data elements from the IMO Conventions and Codes. (24) The processing of personal data within the framework of this Regulation by competent authorities should comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (7). The processing of personal data by the Commission within the framework of this Regulation should comply with Regulation (EU) 2018/1725 of the European Parliament and of the Council (8). (25) The EMSWe and the maritime National Single Windows should not provide any other grounds for any processing of personal data than what is required for their functioning and should not be used to grant any new access rights to personal data. (26) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of supplementing this Regulation by establishing and amending the EMSWe data set and by determining definitions, categories and data specifications for the data elements, and in respect of amending the Annex to incorporate reporting obligations existing at national level as well as to take into account any new reporting obligations adopted by the Union legal acts. The Commission should ensure that the common data requirements, formats and codes established in the Union and international legal acts listed in the Annex are respected. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (9). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (27) When preparing delegated acts, the Commission should ensure that Member States’ experts and the business community are consulted in a transparent manner, and well in advance. (28) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (10). (29) In particular, implementing powers should be conferred on the Commission to lay down the functional and technical specifications, quality control mechanisms and procedures for deploying, maintaining and employing the harmonised interface module and the related harmonised elements of the maritime National Single Windows. Implementing powers should also be conferred on the Commission to lay down the technical specifications, standards and procedures for common services of the EMSWe. (30) This Regulation should build on Regulation (EU) No 910/2014 of the European Parliament and of the Council (11) which lays down conditions under which Member States recognise certain means of electronic identification for natural and legal persons falling under a notified electronic identification scheme of another Member State. Regulation (EU) No 910/2014 establishes the conditions for users to be able to use their electronic identification and authentication means in order to access online public services in cross-border situations. (31) The Commission should carry out an evaluation of this Regulation. Information should be collected in order to inform that evaluation and allow the assessment of the performance of this Regulation against the objectives it pursues. The Commission should also evaluate, among other options, the added value of establishing a centralised and harmonised European reporting system, such as a central reporting interface. (32) Directive 2010/65/EU should therefore be repealed, with effect from the date of the application of this Regulation. (33) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (12), HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope This Regulation establishes a framework for a technologically neutral and interoperable European Maritime Single Window environment (‘EMSWe’) with harmonised interfaces, in order to facilitate the electronic transmission of information in relation to reporting obligations for ships arriving at, staying in and departing from a Union port. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘European Maritime Single Window environment’ (‘EMSWe’) means the legal and technical framework for the electronic transmission of information in relation to reporting obligations for port calls in the Union, which consists of a network of maritime National Single Windows with harmonised reporting interfaces and includes data exchanges via SafeSeaNet and other relevant systems as well as common services for user registry and access management, addressing, ship identification, location codes and information on dangerous and polluting goods and on health; (2) ‘ship’ means any seagoing vessel or craft operating in the marine environment that is subject to a particular reporting obligation listed in the Annex; (3) ‘maritime National Single Window’ means a nationally established and operated technical platform for receiving, exchanging and forwarding electronically information to fulfil reporting obligations, which includes commonly defined management of access rights, a harmonised reporting interface module and a graphical user interface for communication with declarants, as well as links with the relevant authorities’ systems and databases at national and at Union level, which enables messages or acknowledgements covering the widest range of decisions taken by all of the participating relevant authorities to be communicated to declarants, and which could also allow, where applicable, for the connection with other reporting means; (4) ‘harmonised reporting interface module’ means a middleware component of the maritime National Single Window through which information can be exchanged between the information system used by the declarant and the relevant maritime National Single Window; (5) ‘reporting obligation’ means the information required by the Union and international legal acts listed in the Annex, as well as by the national legislation and requirements referred to in the Annex which has to be provided in connection with a port call; (6) ‘port call’ means the arrival of a ship at, the stay of a ship in, and the departure of a ship from a maritime port in a Member State; (7) ‘data element’ means the smallest unit of information which has a unique definition and precise technical characteristics such as format, length and character type; (8) ‘EMSWe data set’ means the complete list of data elements stemming from reporting obligations; (9) ‘graphical user interface’ means a web interface for two-way web-based user-to-system data submission to a maritime National Single Window, allowing declarants to enter data manually, inter alia, by means of harmonised digital spreadsheets and functions that enable reporting data elements to be extracted from those spreadsheets, as well as including common functionalities and features that ensure a common navigation flow and data upload experience for the declarants; (10) ‘common addressing service’ means an additional voluntary service for declarants for initiating direct system-to-system data connections between the system of a declarant and the harmonised reporting interface module of the respective maritime National Single Window; (11) ‘declarant’ means any natural or legal person who is subject to reporting obligations or any duly authorised natural or legal person acting on that person’s behalf within the limits of the relevant reporting obligation; (12) ‘customs authorities’ means the authorities defined in point (1) of Article 5 of Regulation (EU) No 952/2013; (13) ‘data service provider’ means a natural or legal person who provides information and communication technology services to a declarant in relation to reporting obligations; (14) ‘electronic transmission of information’ means the process of transmitting information that has been encoded digitally, using a revisable structured format which can be used directly for data storage and processing by computers; (15) ‘provider of port services’ means any natural or legal person who provides one or more categories of the port services listed in Article 1(2) of Regulation (EU) 2017/352 of the European Parliament and of the Council (13). CHAPTER II EMSWe DATA SET Article 3 Establishment of the EMSWe data set 1. The Commission shall establish and amend the EMSWe data set pursuant to paragraph 3 of this Article. 2. By 15 February 2020, the Member States shall notify the Commission of any reporting obligations stemming from national legislation and requirements, as well as of the data elements to be included in the EMSWe data set. They shall precisely identify those data elements. 3. The Commission is empowered to adopt delegated acts in accordance with Article 23 in order to amend the Annex to this Regulation for the purpose of introducing, deleting or adapting references to national legislation or requirements, Union or international legal acts, and in order to establish and amend the EMSWe data set. The first such delegated act shall be adopted by 15 August 2021. As set out in Article 4, a Member State may request the Commission to introduce or amend data elements in the EMSWe data set, in accordance with the reporting obligations contained in the national legislation and requirements. When assessing whether data elements are to be included in the EMSWe data set, the Commission shall take into account safety concerns, as well as the principles of the FAL Convention, namely the principle of only requiring the reporting of essential information and keeping the number of items to a minimum. The Commission shall decide, within three months after the request, whether to introduce the data elements in the EMSWe data set. The Commission shall justify its decision. A delegated act which introduces or amends a data element in the EMSWe data set shall include an explicit reference to the national legislation and requirements referred to in the third subparagraph. In the event that the Commission decides not to introduce the requested data element, the Commission shall give substantiated grounds for its refusal, with reference to the safety of navigation and the principles of the FAL Convention. Article 4 Amendments to the EMSWe data set 1. Where a Member State intends to amend a reporting obligation under in its national legislation and requirements which would involve the provision of information other than the information that is included in the EMSWe data set, that Member State shall immediately notify the Commission. In that notification, the Member State shall precisely identify the information that is not covered by the EMSWe data set and shall indicate the intended period during which the reporting obligation in question is to apply. 2. A Member State shall not introduce new reporting obligations unless such introduction has been approved by the Commission through the procedure set out in Article 3 and the corresponding information has been incorporated in the EMSWe data set and applied in the harmonised reporting interfaces. 3. The Commission shall assess the necessity of amending the EMSWe data set in accordance with Article 3(3). Amendments to the EMSWe data set shall only be introduced once a year, except in duly justified cases. 4. In exceptional circumstances, a Member State may ask declarants to provide additional data elements without the approval of the Commission during a period of less than three months. The Member State shall notify those data elements to the Commission without delay. The Commission may allow the Member State to continue to request the additional data elements for two further periods of three months if the exceptional circumstances persist. No later than one month before the end of the last three-month period referred to in the first subparagraph, the Member State may request the Commission that the additional data elements become part of the EMSWe data set, in accordance with Article 3(3). The Member State may continue to ask declarants to provide the additional data elements until a decision by the Commission has been taken, and in the event of a positive decision, until the amended EMSWe data set has been implemented. CHAPTER III PROVISION OF INFORMATION Article 5 Maritime National Single Window 1. Each Member State shall establish a maritime National Single Window through which, in accordance with this Regulation and without prejudice to Articles 7 and 11, all information necessary for the fulfilment of reporting obligations shall be provided once, by means of and in compliance with the EMSWe data set, using the harmonised reporting interface module and the graphical user interface as set out in Article 6 and, where applicable, other reporting means as set out in Article 7, for the purpose of making this information available to the relevant authorities of the Member States to the extent necessary to allow those authorities to perform their respective functions. Member States shall be responsible for the operation of their maritime National Single Window. Member States may jointly establish a maritime single window with one or more other Member States. Those Member States shall designate that maritime single window as their maritime National Single Window, and shall remain responsible for its operation in accordance with this Regulation. 2. Member States which do not have maritime ports shall be exempted from the obligation to develop, establish, operate and make available a maritime National Single Window which is set out in paragraph 1. 3. The Member States shall ensure: (a) the compatibility of the maritime National Single Window with the harmonised reporting interface module and adherence of the graphical user interface of their maritime National Single Window to the common functionalities in accordance with Article 6(2); (b) the timely integration of the harmonised reporting interfaces in accordance with the implementation dates set in the implementing act referred to in Article 6 and any subsequent updates in accordance with the dates agreed in the Multi-annual Implementation Plan (MIP); (c) a connection with the relevant systems of competent authorities, to enable the transfer of data to be reported to those authorities, through the maritime National Single Window, and to those systems, in accordance with Union legal acts and national legislation and requirements, and in compliance with the technical specifications of those systems; (d) the provision of a helpdesk during the first 12 months from 15 August 2025 and an online support website for their maritime National Single Window with clear instructions in the official language(s) of that Member State and, where relevant, in a language that is internationally used; (e) the provision of adequate and necessary training for staff who are directly involved in the operation of the maritime National Single Window. 4. Member States shall ensure that the required information reaches the authorities in charge of the application of the legislation in question, and is limited to the needs of each of those authorities. In doing so, Member States shall ensure compliance with the legal requirements related to the transmission of information, provided for in the Union legal acts listed in the Annex and, where applicable, use the electronic data-processing techniques referred to in Article 6(1) of Regulation (EU) No 952/2013. Member States shall also ensure interoperability with the information systems used by those authorities. 5. The maritime National Single Window shall provide the technical possibility for declarants to make available, separately, to providers of port services at the port of destination a subset of data elements pre-defined at national level. 6. Where a Member State does not require all of the elements of the EMSWe data set for the fulfilment of reporting obligations, the maritime National Single Window shall accept submissions that are limited to the data elements that are required by that Member State. The maritime National Single Window shall also accept submissions by declarants that include additional elements of the EMSWe data set; however, it does not need to process and store those additional elements. 7. Member States shall store the information submitted to their respective maritime National Single Windows only for the period of time necessary to ensure the fulfilment of the requirements set out in this Regulation and to ensure compliance with the Union, international and national legal acts listed in the Annex. Member States shall immediately delete such information thereafter. 8. Member States shall make publicly available estimated and actual arrival and departure times of ships in an electronic format harmonised at Union level, on the basis of the data submitted by declarants to the maritime National Single Window. This obligation shall not apply to ships carrying sensitive cargo, where the publication of such information by the maritime National Single Window could pose a threat to security. 9. The maritime National Single Windows shall have a uniform internet address. 10. The Commission shall adopt implementing acts laying down a harmonised structure for the support website referred to in point (d) of paragraph 3, technical specifications for making available arrival and departure times referred to in paragraph 8, and a uniform format for internet addresses referred to in paragraph 9. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2021. Article 6 Harmonised Reporting Interfaces 1. The Commission shall, in close cooperation with the Member States, adopt implementing acts laying down the functional and technical specifications for the harmonised reporting interface module for the maritime National Single Windows. The functional and technical specifications shall aim to facilitate the interoperability with different technologies and reporting systems of the users. The first such implementing act shall be adopted by 15 August 2021. 2. The Commission shall, in close cooperation with the Member States, develop by 15 August 2022 and thereafter update the harmonised reporting interface module for the maritime National Single Windows in conformity with the specifications referred to in paragraphs 1 and 5 of this Article. 3. The Commission shall provide the Member States with the harmonised reporting interface module and all relevant information for the integration into their maritime National Single Window. 4. The Commission shall adopt implementing acts laying down the common functionalities of the graphical user interface and the templates of the harmonised digital spreadsheets referred to in Article 2(9). The first such implementing act shall be adopted by 15 August 2021. 5. The Commission shall adopt implementing acts amending the technical specifications, standards and procedures, in order to ensure that the harmonised reporting interfaces are open to future technologies. 6. The implementing acts referred to in this Article shall be adopted in accordance with the advisory procedure referred to in Article 24(2). Article 7 Other means of reporting 1. Member States shall allow declarants to provide, on a voluntary basis, information to the maritime National Single Window through data service providers that comply with the requirements of the harmonised reporting interface module. 2. Member States may allow declarants to provide the information through other reporting channels provided that those channels are voluntary for the declarants. In such cases, Member States shall ensure that those other channels make the relevant information available to the maritime National Single Window. 3. Member States may use alternative means for the provision of information in the event of a temporary failure of any of the electronic systems referred to in Articles 5 and 6 and Articles 12 to 17. Article 8 Once-only principle 1. Without prejudice to Article 11(1), unless otherwise required by Union law, Member States shall ensure that the declarant is requested to provide the information pursuant to this Regulation only once per port call, and that the relevant data elements of the EMSWe data set are made available and reused in accordance with paragraph 3 of this Article. 2. The Commission shall ensure that the ship identification information, particulars and exemptions that are provided through the maritime National Single Window are recorded in the EMSWe ship database referred to in Article 14 and are made available for any subsequent port calls within the Union. 3. Member States shall ensure that the data elements of the EMSWe data set provided at departure from a port in the Union are made available to the declarant for the purpose of fulfilling the reporting obligations at arrival to the next port in the Union, provided that the ship has not called at a port outside of the Union during that voyage. This paragraph shall not apply to information received pursuant to Regulation (EU) No 952/2013, unless the possibility of making such information available for such purpose is provided for in that Regulation. 4. Any relevant data elements of the EMSWe data set received in accordance with this Regulation shall be made available to other maritime National Single Windows via the SafeSeaNet. 5. The Commission shall adopt implementing acts laying down the list of relevant data elements referred to in paragraphs 3 and 4 of this Article. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). Article 9 Responsibility for the information communicated The declarant shall be responsible for ensuring the submission of data elements in compliance with the applicable legal and technical requirements. The declarant shall remain responsible for the data and for updating any information that has changed after the submission to the maritime National Single Window. Article 10 Data protection and confidentiality 1. The processing of personal data by competent authorities within the framework of this Regulation shall comply with Regulation (EU) 2016/679. 2. The processing of personal data by the Commission within the framework of this Regulation shall comply with Regulation (EU) 2018/1725. 3. Member States and the Commission shall take the necessary measures in accordance with the applicable Union or national law to ensure the confidentiality of commercial and other sensitive information exchanged pursuant to this Regulation. Article 11 Additional provisions for customs 1. This Regulation shall not prevent the exchange of information between customs authorities of the Member States, or between customs authorities and economic operators, using the electronic data-processing techniques referred to in Article 6(1) of Regulation (EU) No 952/2013. 2. The relevant information in the Entry Summary Declaration referred to in Article 127 of Regulation (EU) No 952/2013, where compatible with Union customs law, shall be made available to the maritime National Single Window for reference and, where appropriate, reused for other reporting obligations listed in the Annex. 3. The Commission shall adopt implementing acts laying down the list of relevant information referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2021. CHAPTER IV COMMON SERVICES Article 12 EMSWe user registry and access management system 1. The Commission shall establish and ensure the availability of a common user registry and access management system for declarants and data service providers that use the maritime National Single Window, as well as for national authorities that access the maritime National Single Window in cases where authentication is required. That common user registry and access management system shall provide for a single user registration by means of an existing Union registry with Union level recognition, federated user management and Union level user monitoring. 2. Each Member State shall designate a national authority to be responsible for the identification and registration of new users and the modification and termination of existing accounts through the system referred to in paragraph 1. 3. For the purpose of access to the maritime National Single Window in different Member States, a declarant or data service provider that is registered in the EMSWe user registry and access management system shall be considered to be registered with the maritime National Single Window in all Member States, and shall operate within the limits of the access rights granted by each Member State in accordance with its national rules. 4. The Commission shall adopt implementing acts laying down the technical specifications, standards and procedures for setting up the common user registry and access management system referred to in paragraph 1, including the functionalities referred to in paragraph 2. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2021. Article 13 Common addressing service 1. The Commission shall develop, in close cooperation with the Member States, an additional voluntary common addressing service, provided that the harmonised reporting interface module has been implemented fully in accordance with Article 6. 2. The Commission, in close cooperation with the Member States, shall adopt implementing acts laying down the functional and technical specifications, quality control mechanisms and procedures for deploying, maintaining and employing the common addressing service. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2024. Article 14 EMSWe Ship Database 1. In accordance with Article 8(2), the Commission shall establish a EMSWe ship database containing a list of ship identification information and particulars, as well as records on ship reporting exemptions. 2. Member States shall ensure the provision of the data referred to in paragraph 1 to the EMSWe ship database on the basis of the data submitted by declarants to the maritime National Single Window. 3. The Commission shall ensure the availability of the ship database data to the maritime National Single Windows for facilitation of ship reporting. 4. The Commission shall adopt implementing acts laying down the technical specifications, standards and procedures for the setting up of the database referred to in paragraph 1 with respect to the collecting, storing, updating and provision of the ship identification information and particulars, as well as records on ship reporting exemptions. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2021. Article 15 Common Location Database 1. The Commission shall establish a common location database that contains a reference list of location codes (14) and port facility codes, as registered in the IMO database GISIS. 2. The Commission shall ensure the availability of the location database to the maritime National Single Windows in order to facilitate ship reporting. 3. Member States shall make information from the location database available at national level through the maritime National Single Window. 4. The Commission shall adopt implementing acts laying down the technical specifications, standards and procedures for the setting up of the common location database referred to in paragraph 1 with respect to collecting, storing, updating and provision of the location and port facility codes. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2021. Article 16 Common Hazmat Database 1. The Commission shall establish a common hazmat database containing a list of dangerous and polluting goods which are to be notified in accordance with Directive 2002/59/EC and IMO FAL 7, taking into consideration the relevant data elements from the IMO Conventions and Codes. 2. The Commission shall ensure the availability of the common hazmat database to the maritime National Single Windows to facilitate ship reporting. 3. The database shall be linked to the relevant entries in the MAR-CIS database developed by European Maritime Safety Agency (EMSA) regarding information on associated hazards and risks of dangerous and polluting goods. 4. The database shall be used both as a reference and a verification tool, at national and Union level, during the reporting process through the maritime National Single Window. 5. Member States shall make information from the common hazmat database available at national level through the maritime National Single Window. 6. The Commission shall adopt implementing acts laying down the technical specifications, standards and procedures for the setting up of the common hazmat database referred to in paragraph 1 with respect to the collecting, storing and provision of the hazmat reference information. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). The first such implementing act shall be adopted by 15 August 2021. Article 17 Common Ship Sanitation Database 1. The Commission shall make available a common ship sanitation database that is able to receive and store data related to the Maritime Declarations of Health under Article 37 of the International Health Regulations 2005 (IHR). Personal data relating to ill persons on board ships shall not be stored on that database. The competent health authorities of the Member States shall have access to the database for the purpose of receiving and exchanging data. 2. Member States that use the ship sanitation database shall make known to the Commission their national authority responsible for user management in relation to that database, including the registration of new users as well as the modification and closure of accounts. 3. The Commission shall adopt implementing acts laying down the technical specifications, standards and procedures for the setting up of the database referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 24(2). CHAPTER V COORDINATION OF THE EMSWe ACTIVITIES Article 18 National coordinators Each Member State shall designate a competent national authority with a clear legal mandate to act as a national coordinator for the EMSWe. The national coordinator shall: (a) act as the national contact point for users and the Commission for all matters relating to the implementation of this Regulation; (b) coordinate the application of this Regulation by the competent national authorities within a Member State and their cooperation; (c) coordinate the activities aiming at ensuring the distribution of data and the connection with the relevant systems of competent authorities as referred in point (c) of Article 5(3). Article 19 Multi-annual Implementation Plan In order to facilitate the timely implementation of this Regulation and to provide quality control mechanisms and procedures for deploying, maintaining and updating the harmonised interface module and the related harmonised elements of the EMSWe, the Commission shall adopt, and revise on a yearly basis, following appropriate consultations of Member States’ experts, a Multi-annual Implementation Plan which shall provide: (a) a plan for the development and updating of the harmonised reporting interfaces and the related harmonised elements of the EMSWe over the following 18 months; (b) a plan for the development of the common addressing service by 15 August 2024; (c) indicative dates for consultation with relevant stakeholders; (d) indicative deadlines for the Member States for the subsequent integration of the harmonised reporting interfaces with the maritime National Single Windows; (e) indicative deadlines for the Commission’s development of a common addressing service following the implementation of the harmonised reporting interface module; (f) testing periods for Member States and declarants to test their connections with any new versions of the harmonised reporting interfaces; (g) testing periods for the common addressing service; (h) indicative phasing-out deadlines for the older versions of the harmonised reporting interfaces for the Member States and declarants. CHAPTER VI FINAL PROVISIONS Article 20 Costs The general budget of the European Union shall cover the costs for: (a) the development and maintenance of the ICT tools by the Commission and EMSA supporting the implementation of this Regulation at Union level; (b) the promotion of the EMSWe at Union level, including among relevant stakeholders, and at the level of relevant international organisations. Article 21 Cooperation with other trade and transport facilitation systems or services Where trade and transport facilitation systems or services have been created by other Union legal acts, the Commission shall coordinate the activities related to those systems or services with a view to achieving synergies and avoiding duplication. Article 22 Review and report Member States shall monitor the application of the EMSWe, and report their findings to the Commission. The report shall include the following indicators: (a) use of the harmonised reporting interface module; (b) use of the graphical user interface; (c) use of other means of reporting as referred to in Article 7. Member States shall submit that report to the Commission on an annual basis, using a template to be provided by the Commission. By 15 August 2027, the Commission shall review the application of this Regulation and shall submit to the European Parliament and the Council an assessment report on the functioning of the EMSWe on the basis of the data and statistics collected. The assessment report shall include, where necessary, an evaluation of emerging technologies which could lead to changes to or the replacement of the harmonised reporting interface module. Article 23 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 3 shall be conferred on the Commission for a period of four years from 14 August 2019. The Commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the four-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension no later than three months before the end of each period. 3. The delegation of power referred to in Article 3 may be revoked at any time by the European Parliament or the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. When adopting a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 3 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 24 Committee procedure 1. The Commission shall be assisted by a Digital Transport and Trade Facilitation Committee. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. Article 25 Repeal of Directive 2010/65/EU Directive 2010/65/EU is repealed from 15 August 2025. References to Directive 2010/65/EU shall be construed as references to this Regulation. Article 26 Entry into force 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 15 August 2025. 3. The functionalities referred to in Article 11(2) and those related to the customs reporting obligations specified in point 7 of Part A of the Annex shall become effective when the electronic systems referred to in Article 6(1) of Regulation (EU) No 952/2013 which are necessary for the application of those reporting obligations are operational, in accordance with the work programme established by the Commission pursuant to Articles 280 and 281 of Regulation (EU) No 952/2013. The Commission shall publish the date on which the conditions of this paragraph have been fulfilled in the ‘C’ series of the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 62, 15.2.2019, p. 265. (2) Position of the European Parliament of 18 April 2019 (not yet published in the Official Journal) and decision of the Council of 13 June 2019. (3) Directive 2010/65/EU of the European Parliament and of the Council of 20 October 2010 on reporting formalities for ships arriving in and/or departing from ports of the Member States and repealing Directive 2002/6/EC (OJ L 283, 29.10.2010, p. 1). (4) International Maritime Organization (IMO) Convention on Facilitation of International Maritime Traffic (the ‘FAL Convention’), adopted on 9 April 1965 and amended on 8 April 2016, Standard 1.1. (5) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1). (6) Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a Community vessel traffic monitoring and information system and repealing Council Directive 93/75/EEC (OJ L 208, 5.8.2002, p. 10). (7) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (8) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (9) OJ L 123, 12.5.2016, p. 1. (10) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (11) Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73). (12) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (13) Regulation (EU) 2017/352 of the European Parliament and of the Council of 15 February 2017 establishing a framework for the provision of port services and common rules on the financial transparency of ports (OJ L 57, 3.3.2017, p. 1). (14) ‘United Nations Code for Trade and Transport Locations’. ANNEX REPORTING OBLIGATIONS A. Reporting obligations stemming from legal acts of the Union This category of reporting obligations includes the information which is to be provided in accordance with the following provisions: 1. Notification for ships arriving in and departing from ports of the Member States Article 4 of Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a Community vessel traffic monitoring and information system (OJ L 208, 5.8.2002, p. 10). 2. Border checks on persons Article 8 of Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1). 3. Notification of dangerous or polluting goods carried on board Article 13 of Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a Community vessel traffic monitoring and information system (OJ L 208, 5.8.2002, p. 10). 4. Notification of waste and residues Article 6 of Directive 2000/59/EC of the European Parliament and of the Council of 27 November 2000 on port reception facilities for ship-generated waste and cargo residues (OJ L 332, 28.12.2000, p. 81). 5. Notification of security information Article 6 of Regulation (EC) No 725/2004 of the European Parliament and of the Council of 31 March 2004 on enhancing ship and port facility security (OJ L 129, 29.4.2004, p. 6). The form set out in the Appendix to this Annex shall be used for identifying the data elements required under Article 6 of Regulation (EC) No 725/2004. 6. Information on persons on board Articles 4(2) and 5(2) of Council Directive 98/41/EC of 18 June 1998 on the registration of persons sailing on board passenger ships operating to or from ports of the Member States of the Community (OJ L 188, 2.7.1998, p. 35). 7. Customs formalities (a) Arrival formalities: — Notification of arrival (Article 133 of Regulation (EU) No 952/2013); — Presentation of goods to customs (Article 139 of Regulation (EU) No 952/2013); — Temporary storage declaration of goods (Article 145 of Regulation (EU) No 952/2013); — Customs status of goods (Articles 153 to 155 of Regulation (EU) No 952/2013; — Electronic transport documents used for transit (Article 233(4)(e) of Regulation (EU) No 952/2013). (b) Departure formalities: — Customs status of goods (Articles 153 to 155 of Regulation (EU) No 952/2013); — Electronic transport documents used for transit (Article 233(4)(e) of Regulation (EU) No 952/2013); — Exit notification (Article 267 of Regulation (EU) No 952/2013); — Exit summary declaration (Articles 271 and 272 of Regulation (EU) No 952/2013); — Re-export notification (Articles 274 and 275 of Regulation (EU) No 952/2013). 8. Safe loading and unloading of bulk carriers Article 7 of Directive 2001/96/EC of the European Parliament and of the Council of 4 December 2001 establishing harmonised requirements and procedures for the safe loading and unloading of bulk carriers (OJ L 13, 16.1.2002, p. 9). 9. Port State control Article 9 and Article 24(2) of Directive 2009/16/EC of the European Parliament and of the Council of 23 April 2009 on port State control (OJ L 131, 28.5.2009, p. 57). 10. Maritime transport statistics Article 3 of the Directive 2009/42/EC of the European Parliament and of the Council of 6 May 2009 on statistical returns in respect of carriage of goods and passengers by sea (OJ L 141, 6.6.2009, p. 29). B. FAL documents and reporting obligations stemming from international legal instruments This category of reporting obligations includes the information which is to be provided in accordance with the FAL Convention and other relevant international legal instruments. 1. FAL 1: General Declaration 2. FAL 2: Cargo Declaration 3. FAL 3: Ship’s Stores Declaration 4. FAL 4: Crew’s Effects Declaration 5. FAL 5: Crew List 6. FAL 6: Passenger List 7. FAL 7: Dangerous Goods 8. Maritime Declaration of Health C. Reporting obligations stemming from national legislation and requirements APPENDIX SHIP PRE-ARRIVAL SECURITY INFORMATION FORM FOR ALL SHIPS PRIOR TO ENTRY INTO THE PORT OF AN EU MEMBER STATE (1974 International Convention for the Safety of Life at Sea (SOLAS) regulation 9 of Chapter XI-2 and Article 6(3) of Regulation (EC) No 725/2004) Text of image Particulars of the ship and contact details IMO number Name of ship Port of registry Flag State Type of ship Call Sign Gross Tonnage Inmarsat call numbers (if available) Name of Company and company identification number CSO name & 24 hour contact details Port of arrival Port facility of arrival (if known) Port and port facility information Expected date and time of arrival of the ship in port (ETA) Primary purpose of call Information required by SOLAS Regulation 9.2.1 of Chapter XI-2 Does the ship have a valid International Ship Security Certificate (ISSC)? YES ISSC NO - why not? Issued by (name of Administration or RSO) Expiry date (dd/mm/yyyy) Does the ship have an approved SSP on board? YES NO Security Level at which the ship is currently operating? Security Level 1 Security Level 2 Security Level 3 Location of ship at the time this report is made List the last ten calls at port facilities in chronological order (most recent call first): No. Date from (dd/mm/yyyy) Date to (dd/mm/yyyy) Port Country UN/LOCODE (if available) Port facility Security Level 1 SL = 2 SL = 3 SL = 4 SL = 5 SL = Text of image No. Date from (dd/mm/yyyy) Date to (dd/mm/yyyy) Port Country UN/LOCODE (if available) Port facility Security Level 6 SL = 7 SL = 8 SL = 9 SL = 10 SL = Did the ship take any special or additional security measures, beyond those in the approved SSP? If the answer is YES, indicate below the special or additional security measures taken by the ship. YES NO No. (as above) Special or additional security measures taken by the ship 1 2 3 4 5 6 7 8 9 10 List the ship-to-ship activities, in chronological order (most recent first), which were carried out during the last ten calls at port facilities listed above. Expand table below or continue on separate page if necessary – insert total number of ship-to-ship activities: Text of image Were the ship security procedures specified in the approved SSP maintained during each of these ship-to-ship activities? If NO, provide details of the security measures applied in lieu in the final column below. YES NO No. Date from (dd/mm/yyyy) Date to (dd/mm/yyyy) Location or Longitude and Latitude Ship-to-ship activity Security measures applied in lieu 1 2 3 4 5 6 7 8 9 10 General description of the cargo aboard the ship Is the ship carrying any dangerous substances as cargo covered by any of Classes 1, 2.1, 2.3, 3, 4.1, 5.1, 6.1, 6.2, 7 or 8 of the IMDG Code? YES NO If YES, confirm Dangerous Goods Manifest (or relevant extract) is attached Confirm a copy of ship’s crew list is attached YES Confirm a copy of the ship’s passenger list is attached YES Other security related information Is there any security-related matter you wish to report? YES Provide details: NO Agent of ship at intended port of arrival Name: Contact details (Tel. no.): Identification of person providing the information Title or Position (delete as appropriate): Master / SSO / CSO / Ship’s agent (as above) Name: Signature: Date/Time/Place of completion of report

European Maritime Single Window environment (EMSWe) European Maritime Single Window environment (EMSWe) SUMMARY OF: Regulation (EU) 2019/1239 establishing a European Maritime Single Window environment WHAT IS THE AIM OF THE REGULATION? It introduces an interoperable European Maritime Single Window environment (EMSWe) with harmonised interfaces*, to simplify reporting obligations* for ships arriving at, staying in and departing from EU ports. It aims to improve the European maritime transport sector’s competitiveness and efficiency by reducing administrative burden, introducing a simplified digital information system to harmonise the existing national systems and reduce the need for paperwork. KEY POINTS The EMSWe is the legal and technical framework for the electronic transmission of information about reporting obligations for ships calling at EU ports. It is a network of maritime national single windows* with harmonised reporting interfaces and includes data exchanges using SafeSeaNet and other systems, as well as services for: user registry and access management; common addressing service; EMSWe ship database; common location database; common hazardous material (‘hazmat’) database; and ship sanitation database. Establishing the common EMSWe data set The regulation maintains the existing maritime national single window in each EU country as the basis for a technologically neutral and interoperable EMSWe. The European Commission is empowered to adopt delegated acts to establish a new common EMSWe data set, incorporating and adapting the most relevant requirements in existing national or EU legislation. EU countries must notify the Commission of any reporting obligations and requirements stemming from national legislation and any data elements they wish to be included in the EMSWe data set. Harmonised reporting Interfaces The Commission will adopt implementing acts laying down the functional and technical specifications for the harmonised reporting interface module for the maritime national single windows, aiming for them to be interoperable with different user technologies and reporting systems. Once-only principle The Convention on Facilitation of International Maritime Traffic (FAL Convention) provides that public authorities must in all cases require only essential reporting information and keep the number of items to a minimum. Under the regulation, EU countries must ensure that ship operators are asked to provide any required information only once per port call, and that relevant supplied data are retained for reuse. Common services As components of the EMSW environment, the Commission establishes: a common access-management and user registry system for declarants and for dataservice providers and national authorities that use the maritime national single window in cases where authentication is required; an additional and optional common addressing service, provided that the harmonised reporting interface module has been fully implemented; a ship database containing a list of vessel identification information and characteristics as well as records on ship reporting exemptions; a common location database containing a reference list of location codes and port facility codes listed in the International Maritime Organization’s Global Integrated Shipping Information System (GISIS) database; a common hazmat database containing a list of dangerous and polluting goods that must be notified; a common ship sanitation database that is able to receive and store data on maritime declarations of health. This does not include personal data relating to sick passengers or crew; a multiannual implementation plan, revised annually. Each EU country designates a competent national authority with a legal mandate to act as a national coordinator for the EMSWe. The regulation does not affect the exchange of information between customs authorities, or between customs authorities and businesses, using the electronic data-processing techniques referred to in Regulation (EU) No 952/2013 (see summary). Repeal Regulation (EU) 2019/1239 repeals Directive 2010/65/EU (see summary) as of 15 August 2025. FROM WHEN DOES THE REGULATION APPLY? It applies from 15 August 2025. BACKGROUND For more information, see: European Maritime Single Window environment (European Commission) European Maritime Single Window (EMSW) (European Maritime Safety Agency). KEY TERMS Harmonised reporting interface module: a middleware (software) component of the maritime national single window through which information can be exchanged between the information system used by the declarant and the relevant maritime national single window. Reporting obligation: the information required by the EU, international and national legislation and requirements (referred to in the Annex) which has to be provided in connection with a port call. Maritime national single window: a nationally established and operated technical platform for receiving, exchanging and forwarding electronically information to fulfil reporting obligations, including management of access rights, a harmonised reporting interface module and a graphical user interface (GUI), as well as links with the relevant authorities’ systems and databases at national and at EU level. MAIN DOCUMENT Regulation (EU) 2019/1239 of the European Parliament and of the Council of 20 June 2019 establishing a European Maritime Single Window environment and repealing Directive 2010/65/EU (OJ L 198, 25.7.2019, pp. 64-87) RELATED DOCUMENTS Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, pp. 73-114) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (recast) (OJ L 269, 10.10.2013, pp. 1-101) Successive amendments to Regulation (EU) No 952/2013 have been incorporated into the original text. This consolidated version is of documentary value only. Directive 2010/65/EU of the European Parliament and of the Council of 20 October 2010 on reporting formalities for ships arriving in and/or departing from ports of the Member States and repealing Directive 2002/6/EC (OJ L 283, 29.10.2010, pp. 1-10) See consolidated version. last update 12.01.2020

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29.6.2013 EN Official Journal of the European Union L 181/15 REGULATION (EU) No 608/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) The Council requested, in its Resolution of 25 September 2008 on a comprehensive European anti-counterfeiting and anti-piracy plan, that Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights (2), be reviewed. (2) The marketing of goods infringing intellectual property rights does considerable damage to right-holders, users or groups of producers, and to law-abiding manufacturers and traders. Such marketing could also be deceiving consumers, and could in some cases be endangering their health and safety. Such goods should, in so far as is possible, be kept off the Union market and measures should be adopted to deal with such unlawful marketing without impeding legitimate trade. (3) The review of Regulation (EC) No 1383/2003 showed that, in the light of economic, commercial and legal developments, certain improvements to the legal framework are necessary to strengthen the enforcement of intellectual property rights by customs authorities, as well as to ensure appropriate legal certainty. (4) The customs authorities should be competent to enforce intellectual property rights with regard to goods, which, in accordance with Union customs legislation, are liable to customs supervision or customs control, and to carry out adequate controls on such goods with a view to preventing operations in breach of intellectual property rights laws. Enforcing intellectual property rights at the border, wherever the goods are, or should have been, under customs supervision or customs control is an efficient way to quickly and effectively provide legal protection to the right-holder as well as the users and groups of producers. Where the release of goods is suspended or goods are detained by customs authorities at the border, only one legal proceeding should be required, whereas several separate proceedings should be required for the same level of enforcement for goods found on the market, which have been disaggregated and delivered to retailers. An exception should be made for goods released for free circulation under the end-use regime, as such goods remain under customs supervision, even though they have been released for free circulation. This Regulation should not apply to goods carried by passengers in their personal luggage provided that those goods are for their own personal use and there are no indications that commercial traffic is involved. (5) Regulation (EC) No 1383/2003 does not cover certain intellectual property rights and certain infringements are excluded from its scope. In order to strengthen the enforcement of intellectual property rights, customs intervention should be extended to other types of infringements not covered by Regulation (EC) No 1383/2003. This Regulation should therefore, in addition to the rights already covered by Regulation (EC) No 1383/2003, also include trade names in so far as they are protected as exclusive property rights under national law, topographies of semiconductor products and utility models and devices which are primarily designed, produced or adapted for the purpose of enabling or facilitating the circumvention of technological measures. (6) Infringements resulting from so-called illegal parallel trade and overruns are excluded from the scope of Regulation (EC) No 1383/2003. Goods subject to illegal parallel trade, namely goods that have been manufactured with the consent of the right-holder but placed on the market for the first time in the European Economic Area without his consent, and overruns, namely goods that are manufactured by a person duly authorised by a right-holder to manufacture a certain quantity of goods, in excess of the quantities agreed between that person and the right-holder, are manufactured as genuine goods and it is therefore not appropriate that customs authorities focus their efforts on such goods. Illegal parallel trade and overruns should therefore also be excluded from the scope of this Regulation. (7) Member States should, in cooperation with the Commission, provide appropriate training for customs officials, in order to ensure the correct implementation of this Regulation. (8) This Regulation, when fully implemented, will further contribute to an internal market which ensures right-holders a more effective protection, fuels creativity and innovation and provides consumers with reliable and high-quality products, which should in turn strengthen cross-border transactions between consumers, businesses and traders. (9) Member States face increasingly limited resources in the field of customs. Therefore, the promotion of risk management technologies and strategies to maximise resources available to customs authorities should be supported. (10) This Regulation solely contains procedural rules for customs authorities. Accordingly, this Regulation does not set out any criteria for ascertaining the existence of an infringement of an intellectual property right. (11) Under the ‘Declaration on the TRIPS Agreement and Public Health’ adopted by the Doha WTO Ministerial Conference on 14 November 2001, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all. Consequently, in line with the Union’s international commitments and its development cooperation policy, with regard to medicines, the passage of which across the customs territory of the Union, with or without transhipment, warehousing, breaking bulk, or changes in the mode or means of transport, is only a portion of a complete journey beginning and terminating beyond the territory of the Union, customs authorities should, when assessing a risk of infringement of intellectual property rights, take account of any substantial likelihood of diversion of such medicines onto the market of the Union. (12) This Regulation should not affect the provisions on the competence of courts, in particular, those of Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (3). (13) Persons, users, bodies or groups of producers, who are in a position to initiate legal proceedings in their own name with respect to a possible infringement of an intellectual property right, should be entitled to submit an application. (14) In order to ensure that intellectual property rights are enforced throughout the Union, it is appropriate to allow persons or entities seeking enforcement of Union-wide rights to apply to the customs authorities of a single Member State. Such applicants should be able to request that those authorities decide that action be taken to enforce the intellectual property right both in their own Member State and in any other Member State. (15) In order to ensure the swift enforcement of intellectual property rights, it should be provided that, where the customs authorities suspect, on the basis of reasonable indications, that goods under their supervision infringe intellectual property rights, they may suspend the release of or detain the goods whether at their own initiative or upon application, in order to enable a person or entity entitled to submit an application to initiate proceedings for determining whether an intellectual property right has been infringed. (16) Regulation (EC) No 1383/2003 allowed Member States to provide for a procedure allowing the destruction of certain goods without there being any obligation to initiate proceedings to establish whether an intellectual property right has been infringed. As recognised in the European Parliament Resolution of 18 December 2008 on the impact of counterfeiting on international trade (4), such procedure has proved very successful in the Member States where it has been available. Therefore, the procedure should be made compulsory with regard to all infringements of intellectual property rights and should be applied, where the declarant or the holder of the goods agrees to destruction. Furthermore, the procedure should provide that customs authorities may deem that the declarant or the holder of the goods has agreed to the destruction of the goods where he has not explicitly opposed destruction within the prescribed period. (17) In order to reduce the administrative burden and costs to a minimum, a specific procedure should be introduced for small consignments of counterfeit and pirated goods, which should allow for such goods to be destroyed without the explicit agreement of the applicant in each case. However, a general request made by the applicant in the application should be required in order for that procedure to be applied. Furthermore, customs authorities should have the possibility to require that the applicant covers the costs incurred by the application of that procedure. (18) For further legal certainty, it is appropriate to modify the timelines for suspending the release of or detaining goods suspected of infringing an intellectual property right and the conditions in which information about detained goods is to be passed on to persons and entities concerned by customs authorities, as provided for in Regulation (EC) No 1383/2003. (19) Taking into account the provisional and preventive character of the measures adopted by the customs authorities when applying this Regulation and the conflicting interests of the parties affected by the measures, some aspects of the procedures should be adapted to ensure the smooth application of this Regulation, whilst respecting the rights of the concerned parties. Thus, with respect to the various notifications envisaged by this Regulation, the customs authorities should notify the relevant person, on the basis of the documents concerning the customs treatment or of the situation in which the goods are placed. Furthermore, since the procedure for destruction of goods implies that both the declarant or the holder of the goods and the holder of the decision should communicate their possible objections to destruction in parallel, it should be ensured that the holder of the decision is given the possibility to react to a potential objection to destruction by the declarant or the holder of the goods. It should therefore be ensured that the declarant or the holder of the goods is notified of the suspension of the release of the goods or their detention before, or on the same day as, the holder of the decision. (20) Customs authorities and the Commission are encouraged to cooperate with the European Observatory on Infringements of Intellectual Property Rights in the framework of their respective competences. (21) With a view to eliminating international trade in goods infringing intellectual property rights, the TRIPS Agreement provides that WTO Members are to promote the exchange of information between customs authorities on such trade. Accordingly, it should be possible for the Commission and the customs authorities of the Member States to share information on suspected breaches of intellectual property rights with the relevant authorities of third countries, including on goods which are in transit through the territory of the Union and originate in or are destined for those third countries. (22) In the interest of efficiency, the provisions of Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs or agricultural matters (5), should apply. (23) The liability of the customs authorities should be governed by the legislation of the Member States, though the granting by the customs authorities of an application should not entitle the holder of the decision to compensation in the event that goods suspected of infringing an intellectual property right are not detected by the customs authorities and are released or no action is taken to detain them. (24) Given that customs authorities take action upon application, it is appropriate to provide that the holder of the decision should reimburse all the costs incurred by the customs authorities in taking action to enforce his intellectual property rights. Nevertheless, this should not preclude the holder of the decision from seeking compensation from the infringer or other persons that might be considered liable under the legislation of the Member State where the goods were found. Such persons might include intermediaries, where applicable. Costs and damages incurred by persons other than customs authorities as a result of a customs action, where the release of goods is suspended or the goods are detained on the basis of a claim of a third party based on intellectual property, should be governed by the specific legislation applicable in each particular case. (25) This Regulation introduces the possibility for customs authorities to allow goods which are to be destroyed to be moved, under customs supervision, between different places within the customs territory of the Union. Customs authorities may furthermore decide to release such goods for free circulation with a view to further recycling or disposal outside commercial channels including for awareness-raising, training and educational purposes. (26) Customs enforcement of intellectual property rights entails the exchange of data on decisions relating to applications. Such processing of data covers also personal data and should be carried out in accordance with Union law, as set out in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (6) and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by Community institutions and bodies and on the free movement of such data (7). (27) The exchange of information relating to decisions on applications and to customs actions should be made via a central electronic database. The entity which will control and manage that database and the entities in charge of ensuring the security of the processing of the data contained in the database should be defined. Introducing any type of possible interoperability or exchange should first and foremost comply with the purpose limitation principle, namely that data should be used for the purpose for which the database has been established, and no further exchange or interconnection should be allowed other than for that purpose. (28) In order to ensure that the definition of small consignments can be adapted if it proves to be impractical, taking into account the need to ensure the effective operation of the procedure, or where necessary to avoid any circumvention of this procedure as regards the composition of consignments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending the non-essential elements of the definition of small consignments, namely the specific quantities set out in that definition. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (29) In order to ensure uniform conditions for the implementation of the provisions concerning defining the elements of the practical arrangements for the exchange of data with third countries and the provisions concerning the forms for the application and for requesting the extension of the period during which customs authorities are to take action, implementing powers should be conferred on the Commission, namely to define those elements of the practical arrangements and to establish standard forms. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (8). For establishing the standard forms, although the subject of the provisions of this Regulation to be implemented falls within the scope of the common commercial policy, given the nature and impacts of those implementing acts, the advisory procedure should be used for their adoption, because all details of what information to include in the forms follows directly from the text of this Regulation. Those implementing acts will therefore only establish the format and structure of the form and will have no further implications for the common commercial policy of the Union. (30) Regulation (EC) No 1383/2003 should be repealed. (31) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 12 October 2011 (9), HAVE ADOPTED THIS REGULATION: CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter and scope 1. This Regulation sets out the conditions and procedures for action by the customs authorities where goods suspected of infringing an intellectual property right are, or should have been, subject to customs supervision or customs control within the customs territory of the Union in accordance with Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (10), particularly goods in the following situations: (a) when declared for release for free circulation, export or re-export; (b) when entering or leaving the customs territory of the Union; (c) when placed under a suspensive procedure or in a free zone or free warehouse. 2. In respect of the goods subject to customs supervision or customs control, and without prejudice to Articles 17 and 18, the customs authorities shall carry out adequate customs controls and shall take proportionate identification measures as provided for in Article 13(1) and Article 72 of Regulation (EEC) No 2913/92 in accordance with risk analysis criteria with a view to preventing acts in breach of intellectual property laws applicable in the territory of the Union and in order to cooperate with third countries on the enforcement of intellectual property rights. 3. This Regulation shall not apply to goods that have been released for free circulation under the end-use regime. 4. This Regulation shall not apply to goods of a non-commercial nature contained in travellers’ personal luggage. 5. This Regulation shall not apply to goods that have been manufactured with the consent of the right-holder or to goods manufactured, by a person duly authorised by a right-holder to manufacture a certain quantity of goods, in excess of the quantities agreed between that person and the right-holder. 6. This Regulation shall not affect national or Union law on intellectual property or the laws of the Member States in relation to criminal procedures. Article 2 Definitions For the purposes of this Regulation: (1) ‘intellectual property right’ means: (a) a trade mark; (b) a design; (c) a copyright or any related right as provided for by national or Union law; (d) a geographical indication; (e) a patent as provided for by national or Union law; (f) a supplementary protection certificate for medicinal products as provided for in Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (11); (g) a supplementary protection certificate for plant protection products as provided for in Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (12); (h) a Community plant variety right as provided for in Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (13); (i) a plant variety right as provided for by national law; (j) a topography of semiconductor product as provided for by national or Union law; (k) a utility model in so far as it is protected as an intellectual property right by national or Union law; (l) a trade name in so far as it is protected as an exclusive intellectual property right by national or Union law; (2) ‘trade mark’ means: (a) a Community trade mark as provided for in Council Regulation (EC) No 207/2009 of 26 February 2009 on the Community trade mark (14); (b) a trade mark registered in a Member State, or, in the case of Belgium, Luxembourg or the Netherlands, at the Benelux Office for Intellectual Property; (c) a trade mark registered under international arrangements which has effect in a Member State or in the Union; (3) ‘design’ means: (a) a Community design as provided for in Council Regulation (EC) No 6/2002 of 12 December 2001 on Community designs (15); (b) a design registered in a Member State, or, in the case of Belgium, Luxembourg or the Netherlands, at the Benelux Office for Intellectual Property; (c) a design registered under international arrangements which has effect in a Member State or in the Union; (4) ‘geographical indication’ means: (a) a geographical indication or designation of origin protected for agricultural products and foodstuff as provided for in Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (16); (b) a designation of origin or geographical indication for wine as provided for in Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (17); (c) a geographical designation for aromatised drinks based on wine products as provided for in Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatized wines, aromatized wine-based drinks and aromatized wine-product cocktails (18); (d) a geographical indication of spirit drinks as provided for in Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks (19); (e) a geographical indication for products not falling under points (a) to (d) in so far as it is established as an exclusive intellectual property right by national or Union law; (f) a geographical indication as provided for in Agreements between the Union and third countries and as such listed in those Agreements; (5) ‘counterfeit goods’ means: (a) goods which are the subject of an act infringing a trade mark in the Member State where they are found and bear without authorisation a sign which is identical to the trade mark validly registered in respect of the same type of goods, or which cannot be distinguished in its essential aspects from such a trade mark; (b) goods which are the subject of an act infringing a geographical indication in the Member State where they are found and, bear or are described by, a name or term protected in respect of that geographical indication; (c) any packaging, label, sticker, brochure, operating instructions, warranty document or other similar item, even if presented separately, which is the subject of an act infringing a trade mark or a geographical indication, which includes a sign, name or term which is identical to a validly registered trade mark or protected geographical indication, or which cannot be distinguished in its essential aspects from such a trade mark or geographical indication, and which can be used for the same type of goods as that for which the trade mark or geographical indication has been registered; (6) ‘pirated goods’ means goods which are the subject of an act infringing a copyright or related right or a design in the Member State where the goods are found and which are, or contain copies, made without the consent of the holder of a copyright or related right or a design, or of a person authorised by that holder in the country of production; (7) ‘goods suspected of infringing an intellectual property right’ means goods with regard to which there are reasonable indications that, in the Member State where those goods are found, they are prima facie: (a) goods which are the subject of an act infringing an intellectual property right in that Member State; (b) devices, products or components which are primarily designed, produced or adapted for the purpose of enabling or facilitating the circumvention of any technology, device or component that, in the normal course of its operation, prevents or restricts acts in respect of works which are not authorised by the holder of any copyright or any right related to copyright and which relate to an act infringing those rights in that Member State; (c) any mould or matrix which is specifically designed or adapted for the manufacture of goods infringing an intellectual property right, if such moulds or matrices relate to an act infringing an intellectual property right in that Member State; (8) ‘right-holder’ means the holder of an intellectual property right; (9) ‘application’ means a request made to the competent customs department for customs authorities to take action with respect to goods suspected of infringing an intellectual property right; (10) ‘national application’ means an application requesting the customs authorities of a Member State to take action in that Member State; (11) ‘Union application’ means an application submitted in one Member State and requesting the customs authorities of that Member State and of one or more other Member States to take action in their respective Member States; (12) ‘applicant’ means the person or entity in whose name an application is submitted; (13) ‘holder of the decision’ means the holder of a decision granting an application; (14) ‘holder of the goods’ means the person who is the owner of the goods suspected of infringing an intellectual property right or who has a similar right of disposal, or physical control, over such goods; (15) ‘declarant’ means the declarant as defined in point (18) of Article 4 of Regulation (EEC) No 2913/92; (16) ‘destruction’ means the physical destruction, recycling or disposal of goods outside commercial channels, in such a way as to preclude damage to the holder of the decision; (17) ‘customs territory of the Union’ means the customs territory of the Community as defined in Article 3 of Regulation (EEC) No 2913/92; (18) ‘release of the goods’ means the release of the goods as defined in point (20) of Article 4 of Regulation (EEC) No 2913/92; (19) ‘small consignment’ means a postal or express courier consignment, which: (a) contains three units or less; or (b) has a gross weight of less than two kilograms. For the purpose of point (a), ‘units’ means goods as classified under the Combined Nomenclature in accordance with Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (20) if unpackaged, or the package of such goods intended for retail sale to the ultimate consumer. For the purpose of this definition, separate goods falling in the same Combined Nomenclature code shall be considered as different units and goods presented as sets classified in one Combined Nomenclature code shall be considered as one unit; (20) ‘perishable goods’ means goods considered by customs authorities to deteriorate by being kept for up to 20 days from the date of their suspension of release or detention; (21) ‘exclusive licence’ means a licence (whether general or limited) authorising the licensee to the exclusion of all other persons, including the person granting the licence, to use an intellectual property right in the manner authorised by the licence. CHAPTER II APPLICATIONS SECTION 1 Submission of applications Article 3 Entitlement to submit an application The following persons and entities shall, to the extent they are entitled to initiate proceedings, in order to determine whether an intellectual property right has been infringed, in the Member State or Member States where the customs authorities are requested to take action, be entitled to submit: (1) a national or a Union application: (a) right-holders; (b) intellectual property collective rights management bodies as referred to in point (c) of Article 4(1) of Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (21); (c) professional defence bodies as referred to in point (d) of Article 4(1) of Directive 2004/48/EC; (d) groups within the meaning of point (2) of Article 3, and Article 49(1) of Regulation (EU) No 1151/2012, groups of producers within the meaning of Article 118e of Regulation (EC) No 1234/2007 or similar groups of producers provided for in Union law governing geographical indications representing producers of products with a geographical indication or representatives of such groups, in particular Regulations (EEC) No 1601/91 and (EC) No 110/2008 and operators entitled to use a geographical indication as well as inspection bodies or authorities competent for such a geographical indication; (2) a national application: (a) persons or entities authorised to use intellectual property rights, which have been authorised formally by the right-holder to initiate proceedings in order to determine whether the intellectual property right has been infringed; (b) groups of producers provided for in the legislation of the Member States governing geographical indications representing producers of products with geographical indications or representatives of such groups and operators entitled to use a geographical indication, as well as inspection bodies or authorities competent for such a geographical indication; (3) a Union application: holders of exclusive licenses covering the entire territory of two or more Member States, where those licence holders have been authorised formally in those Member States by the right-holder to initiate proceedings in order to determine whether the intellectual property right has been infringed. Article 4 Intellectual property rights covered by Union applications A Union application may be submitted only with respect to intellectual property rights based on Union law producing effects throughout the Union. Article 5 Submission of applications 1. Each Member State shall designate the customs department competent to receive and process applications (‘competent customs department’). The Member State shall inform the Commission accordingly and the Commission shall make public a list of competent customs departments designated by the Member States. 2. Applications shall be submitted to the competent customs department. The applications shall be completed using the form referred to in Article 6 and shall contain the information required therein. 3. Where an application is submitted after notification by the customs authorities of the suspension of the release or detention of the goods in accordance with Article 18(3), that application shall comply with the following: (a) it is submitted to the competent customs department within four working days of the notification of the suspension of the release or detention of the goods; (b) it is a national application; (c) it contains the information referred to in Article 6(3). The applicant may, however, omit the information referred to in point (g), (h) or (i) of that paragraph. 4. Except in the circumstances referred to in point (3) of Article 3, only one national application and one Union application may be submitted per Member State for the same intellectual property right protected in that Member State. In the circumstances referred to in point (3) of Article 3, more than one Union application shall be allowed. 5. Where a Union application is granted for a Member State already covered by another Union application granted to the same applicant and for the same intellectual property right, the customs authorities of that Member State shall take action on the basis of the Union application first granted. They shall inform the competent customs department of the Member State where any subsequent Union application was granted, which shall, amend or revoke the decision granting that subsequent Union application. 6. Where computerised systems are available for the purpose of receiving and processing applications, applications as well as attachments shall be submitted using electronic data-processing techniques. Member States and the Commission shall develop, maintain and employ such systems in accordance with the multi-annual strategic plan referred to in Article 8(2) of Decision No 70/2008/EC of the European Parliament and of the Council of 15 January 2008 on a paperless customs environment for customs and trade (22). Article 6 Application form 1. The Commission shall establish an application form by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 34(2). 2. The application form shall specify the information that has to be provided to the data subject pursuant to Regulation (EC) No 45/2001 and national laws implementing Directive 95/46/EC. 3. The Commission shall ensure that the following information is required of the applicant in the application form: (a) details concerning the applicant; (b) the status, within the meaning of Article 3, of the applicant; (c) documents providing evidence to satisfy the competent customs department that the applicant is entitled to submit the application; (d) where the applicant submits the application by means of a representative, details of the person representing him and evidence of that person’s powers to act as representative, in accordance with the legislation of the Member State in which the application is submitted; (e) the intellectual property right or rights to be enforced; (f) in the case of a Union application, the Member States in which customs action is requested; (g) specific and technical data on the authentic goods, including markings such as bar-coding and images where appropriate; (h) the information needed to enable the customs authorities to readily identify the goods in question; (i) information relevant to the customs authorities’ analysis and assessment of the risk of infringement of the intellectual property right or the intellectual property rights concerned, such as the authorised distributors; (j) whether information provided in accordance with point (g), (h) or (i) of this paragraph is to be marked for restricted handling in accordance with Article 31(5); (k) the details of any representative designated by the applicant to take charge of legal and technical matters; (l) an undertaking by the applicant to notify the competent customs department of any of the situations laid down in Article 15; (m) an undertaking by the applicant to forward and update any information relevant to the customs authorities’ analysis and assessment of the risk of infringement of the intellectual property right(s) concerned; (n) an undertaking by the applicant to assume liability under the conditions laid down in Article 28; (o) an undertaking by the applicant to bear the costs referred to in Article 29 under the conditions laid down in that Article; (p) an agreement by the applicant that the data provided by him may be processed by the Commission and by the Member States; (q) whether the applicant requests the use of the procedure referred to in Article 26 and, where requested by the customs authorities, agrees to cover the costs related to destruction of goods under that procedure. SECTION 2 Decisions on applications Article 7 Processing of incomplete applications 1. Where, on receipt of an application, the competent customs department considers that the application does not contain all the information required by Article 6(3), the competent customs department shall request the applicant to supply the missing information within 10 working days of notification of the request. In such cases, the time-limit referred to in Article 9(1) shall be suspended until the relevant information is received. 2. Where the applicant does not provide the missing information within the period referred to in the first subparagraph of paragraph 1, the competent customs department shall reject the application. Article 8 Fees The applicant shall not be charged a fee to cover the administrative costs resulting from the processing of the application. Article 9 Notification of decisions granting or rejecting applications 1. The competent customs department shall notify the applicant of its decision granting or rejecting the application within 30 working days of the receipt of the application. In the event of rejection, the competent customs department shall provide reasons for its decision and include information on the appeal procedure. 2. If the applicant has been notified of the suspension of the release or the detention of the goods by the customs authorities before the submission of an application, the competent customs department shall notify the applicant of its decision granting or rejecting the application within two working days of the receipt of the application. Article 10 Decisions concerning applications 1. A decision granting a national application and any decision revoking or amending it shall take effect in the Member State in which the national application was submitted from the day following the date of adoption. A decision extending the period during which customs authorities are to take action shall take effect in the Member State in which the national application was submitted on the day following the date of expiry of the period to be extended. 2. A decision granting a Union application and any decision revoking or amending it shall take effect as follows: (a) in the Member State in which the application was submitted, on the day following the date of adoption; (b) in all other Member States where action by the customs authorities is requested, on the day following the date on which the customs authorities are notified in accordance with Article 14(2), provided that the holder of the decision has fulfilled his obligations under Article 29(3) with regard to translation costs. A decision extending the period during which customs authorities are to take action shall take effect in the Member State in which the Union application was submitted and in all other Member States where action by the customs authorities is requested the day following the date of expiry of the period to be extended. Article 11 Period during which the customs authorities are to take action 1. When granting an application, the competent customs department shall specify the period during which the customs authorities are to take action. That period shall begin on the day the decision granting the application takes effect, pursuant to Article 10, and shall not exceed one year from the day following the date of adoption. 2. Where an application submitted after notification by the customs authorities of the suspension of the release or detention of the goods in accordance with Article 18(3) does not contain the information referred to in point (g), (h) or (i) of Article 6(3), it shall be granted only for the suspension of the release or detention of those goods, unless that information is provided within 10 working days after the notification of the suspension of the release or detention of the goods. 3. Where an intellectual property right ceases to have effect or where the applicant ceases for other reasons to be entitled to submit an application, no action shall be taken by the customs authorities. The decision granting the application shall be revoked or amended accordingly by the competent customs department that granted the decision. Article 12 Extension of the period during which the customs authorities are to take action 1. On expiry of the period during which the customs authorities are to take action, and subject to the prior discharge by the holder of the decision of any debt owed to the customs authorities under this Regulation, the competent customs department which adopted the initial decision may, at the request of the holder of the decision, extend that period. 2. Where the request for extension of the period during which the customs authorities are to take action is received by the competent customs department less than 30 working days before the expiry of the period to be extended, it may refuse that request. 3. The competent customs department shall notify its decision on the extension to the holder of the decision within 30 working days of the receipt of the request referred to in paragraph 1. The competent customs department shall specify the period during which the customs authorities are to take action. 4. The extended period during which the customs authorities are to take action shall run from the day following the date of expiry of the previous period and shall not exceed one year. 5. Where an intellectual property right ceases to have effect or where the applicant ceases for other reasons to be entitled to submit an application, no action shall be taken by the customs authorities. The decision granting the extension shall be revoked or amended accordingly by the competent customs department that granted the decision. 6. The holder of the decision shall not be charged a fee to cover the administrative costs resulting from the processing of the request for extension. 7. The Commission shall establish an extension request form by means of implementing acts. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 34(2). Article 13 Amending the decision with regard to intellectual property rights. The competent customs department that adopted the decision granting the application may, at the request of the holder of that decision, modify the list of intellectual property rights in that decision. Where a new intellectual property right is added, the request shall contain the information referred to in points (c), (e), (g), (h) and (i) of Article 6(3). In the case of a decision granting a Union application, any modification consisting of the addition of intellectual property rights shall be limited to intellectual property rights covered by Article 4. Article 14 Notification obligations of the competent customs department 1. The competent customs department to which a national application has been submitted shall forward the following decisions to the customs offices of its Member State, immediately after their adoption: (a) decisions granting the application; (b) decisions revoking decisions granting the application; (c) decisions amending decisions granting the application; (d) decisions extending the period during which the customs authorities are to take action. 2. The competent customs department to which a Union application has been submitted shall forward the following decisions to the competent customs department of the Member State or Member States indicated in the Union application, immediately after their adoption: (a) decisions granting the application; (b) decisions revoking decisions granting the application; (c) decisions amending decisions granting the application; (d) decisions extending the period during which the customs authorities are to take action. The competent customs department of the Member State or Member States indicated in the Union application shall immediately after receiving those decisions forward them to their customs offices. 3. The competent customs department of the Member State or Member States indicated in the Union application may request the competent customs department that adopted the decision granting the application to provide them with additional information deemed necessary for the implementation of that decision. 4. The competent customs department shall forward its decision suspending the actions of the customs authorities under point (b) of Article 16(1) and Article 16(2) to the customs offices of its Member State, immediately after its adoption. Article 15 Notification obligations of the holder of the decision The holder of the decision shall immediately notify the competent customs department that granted the application of any of the following: (a) an intellectual property right covered by the application ceases to have effect; (b) the holder of the decision ceases for other reasons to be entitled to submit the application; (c) modifications to the information referred to in Article 6(3). Article 16 Failure of the holder of the decision to fulfil his obligations 1. Where the holder of the decision uses the information provided by the customs authorities for purposes other than those provided for in Article 21, the competent customs department of the Member State where the information was provided or misused may: (a) revoke any decision adopted by it granting a national application to that holder of the decision, and refuse to extend the period during which the customs authorities are to take action; (b) suspend in their territory, during the period during which the customs authorities are to take action, any decision granting a Union application to that holder of the decision. 2. The competent customs department may decide to suspend the actions of the customs authorities until the expiry of the period during which those authorities are to take action, where the holder of the decision: (a) does not fulfil the notification obligations set out in Article 15; (b) does not fulfil the obligation on returning samples set out in Article 19(3); (c) does not fulfil the obligations on costs and translation set out in Article 29(1) and (3); (d) without valid reason does not initiate proceedings as provided for in Article 23(3) or Article 26(9). In the case of a Union application, the decision to suspend the actions of the customs authorities shall have effect only in the Member State where such decision is taken. CHAPTER III ACTION BY THE CUSTOMS AUTHORITIES SECTION 1 Suspension of the release or detention of goods suspected of infringing an intellectual property right Article 17 Suspension of the release or detention of the goods following the grant of an application 1. Where the customs authorities identify goods suspected of infringing an intellectual property right covered by a decision granting an application, they shall suspend the release of the goods or detain them. 2. Before suspending the release of or detaining the goods, the customs authorities may ask the holder of the decision to provide them with any relevant information with respect to the goods. The customs authorities may also provide the holder of the decision with information about the actual or estimated quantity of goods, their actual or presumed nature and images thereof, as appropriate. 3. The customs authorities shall notify the declarant or the holder of the goods of the suspension of the release of the goods or the detention of the goods within one working day of that suspension or detention. Where the customs authorities opt to notify the holder of the goods and two or more persons are considered to be the holder of the goods, the customs authorities shall not be obliged to notify more than one of those persons. The customs authorities shall notify the holder of the decision of the suspension of the release of the goods or the detention on the same day as, or promptly after, the declarant or the holder of the goods is notified. The notifications shall include information on the procedure set out in Article 23. 4. The customs authorities shall inform the holder of the decision and the declarant or the holder of the goods of the actual or estimated quantity and the actual or presumed nature of the goods, including available images thereof, as appropriate, whose release has been suspended or which have been detained. The customs authorities shall also, upon request and where available to them, inform the holder of the decision of the names and addresses of the consignee, the consignor and the declarant or the holder of the goods, of the customs procedure and of the origin, provenance and destination of the goods whose release has been suspended or which have been detained. Article 18 Suspension of the release or detention of the goods before the grant of an application 1. Where the customs authorities identify goods suspected of infringing an intellectual property right, which are not covered by a decision granting an application, they may, except for in the case of perishable goods, suspend the release of those goods or detain them. 2. Before suspending the release of or detaining the goods suspected of infringing an intellectual property right, the customs authorities may, without disclosing any information other than the actual or estimated quantity of goods, their actual or presumed nature and images thereof, as appropriate, request any person or entity potentially entitled to submit an application concerning the alleged infringement of the intellectual property rights to provide them with any relevant information. 3. The customs authorities shall notify the declarant or the holder of the goods of the suspension of the release of the goods or their detention within one working day of that suspension or detention. Where the customs authorities opt to notify the holder of the goods and two or more persons are considered to be the holder of the goods, the customs authorities shall not be obliged to notify more than one of those persons. The customs authorities shall notify persons or entities entitled to submit an application concerning the alleged infringement of the intellectual property rights, of the suspension of the release of the goods or their detention on the same day as, or promptly after, the declarant or the holder of the goods is notified. The customs authorities may consult the competent public authorities in order to identify the persons or entities entitled to submit an application. The notifications shall include information on the procedure set out in Article 23. 4. The customs authorities shall grant the release of the goods or put an end to their detention immediately after completion of all customs formalities in the following cases: (a) where they have not identified any person or entity entitled to submit an application concerning the alleged infringement of intellectual property rights within one working day from the suspension of the release or the detention of the goods; (b) where they have not received an application in accordance with Article 5(3), or where they have rejected such an application. 5. Where an application has been granted, the customs authorities shall, upon request and where available to them, inform the holder of the decision of the names and addresses of the consignee, the consignor and the declarant or the holder of the goods, of the customs procedure and of the origin, provenance and destination of the goods whose release has been suspended or which have been detained. Article 19 Inspection and sampling of goods whose release has been suspended or which have been detained 1. The customs authorities shall give the holder of the decision and the declarant or the holder of the goods the opportunity to inspect the goods whose release has been suspended or which have been detained. 2. The customs authorities may take samples that are representative of the goods. They may provide or send such samples to the holder of the decision, at the holder’s request and strictly for the purposes of analysis and to facilitate the subsequent procedure in relation to counterfeit and pirated goods. Any analysis of those samples shall be carried out under the sole responsibility of the holder of the decision. 3. The holder of the decision shall, unless circumstances do not allow, return the samples referred to in paragraph 2 to the customs authorities on completion of the analysis, at the latest before the goods are released or their detention is ended. Article 20 Conditions for storage The conditions of storage of goods during a period of suspension of release or detention shall be determined by the customs authorities. Article 21 Permitted use of certain information by the holder of the decision Where the holder of the decision has received the information referred to in Article 17(4), Article 18(5), Article 19 or Article 26(8), he may disclose or use that information only for the following purposes: (a) to initiate proceedings to determine whether an intellectual property right has been infringed and in the course of such proceedings; (b) in connection with criminal investigations related to the infringement of an intellectual property right and undertaken by public authorities in the Member State where the goods are found; (c) to initiate criminal proceedings and in the course of such proceedings; (d) to seek compensation from the infringer or other persons; (e) to agree with the declarant or the holder of the goods that the goods be destroyed in accordance with Article 23(1); (f) to agree with the declarant or the holder of the goods of the amount of the guarantee referred to in point (a) of Article 24(2). Article 22 Sharing of information and data between customs authorities 1. Without prejudice to applicable provisions on data protection in the Union and for the purpose of contributing to eliminating international trade in goods infringing intellectual property rights, the Commission and the customs authorities of the Member States may share certain data and information available to them with the relevant authorities in third countries according to the practical arrangements referred to in paragraph 3. 2. The data and information referred to in paragraph 1 shall be exchanged to swiftly enable effective enforcement against shipments of goods infringing an intellectual property right. Such data and information may relate to seizures, trends and general risk information, including on goods which are in transit through the territory of the Union and which have originated in or are destined for the territory of third countries concerned. Such data and information may include, where appropriate, the following: (a) nature and quantity of goods; (b) suspected intellectual property right infringed; (c) origin, provenance and destination of the goods; (d) information on movements of means of transport, in particular: (i) name of vessel or registration of means of transport; (ii) reference numbers of freight bill or other transport document; (iii) number of containers; (iv) weight of load; (v) description and/or coding of goods; (vi) reservation number; (vii) seal number; (viii) place of first loading; (ix) place of final unloading; (x) places of transhipment; (xi) expected date of arrival at place of final unloading; (e) information on movements of containers, in particular: (i) container number; (ii) container loading status; (iii) date of movement; (iv) type of movement (loaded, unloaded, transhipped, entered, left, etc.); (v) name of vessel or registration of means of transport; (vi) number of voyage/journey; (vii) place; (viii) freight bill or other transport document. 3. The Commission shall adopt implementing acts defining the elements of the necessary practical arrangements concerning the exchange of data and information referred to in paragraphs 1 and 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(3). SECTION 2 Destruction of goods, initiation of proceedings and early release of goods Article 23 Destruction of goods and initiation of proceedings 1. Goods suspected of infringing an intellectual property right may be destroyed under customs control, without there being any need to determine whether an intellectual property right has been infringed under the law of the Member State where the goods are found, where all of the following conditions are fulfilled: (a) the holder of the decision has confirmed in writing to the customs authorities, within 10 working days, or three working days in the case of perishable goods, of notification of the suspension of the release or the detention of the goods, that, in his conviction, an intellectual property right has been infringed; (b) the holder of the decision has confirmed in writing to the customs authorities, within 10 working days, or three working days in the case of perishable goods, of notification of the suspension of the release or the detention of the goods, his agreement to the destruction of the goods; (c) the declarant or the holder of the goods has confirmed in writing to the customs authorities, within 10 working days, or three working days in the case of perishable goods, of notification of the suspension of the release or the detention of the goods, his agreement to the destruction of the goods. Where the declarant or the holder of the goods has not confirmed his agreement to the destruction of the goods nor notified his opposition thereto to the customs authorities, within those deadlines, the customs authorities may deem the declarant or the holder of the goods to have confirmed his agreement to the destruction of those goods. The customs authorities shall grant the release of the goods or put an end to their detention, immediately after completion of all customs formalities, where within the periods referred to in points (a) and (b) of the first subparagraph, they have not received both the written confirmation from the holder of the decision that, in his conviction, an intellectual property right has been infringed and his agreement to destruction, unless those authorities have been duly informed about the initiation of proceedings to determine whether an intellectual property right has been infringed. 2. The destruction of the goods shall be carried out under customs control and under the responsibility of the holder of the decision, unless otherwise specified in the national law of the Member State where the goods are destroyed. Samples may be taken by competent authorities prior to the destruction of the goods. Samples taken prior to destruction may be used for educational purposes. 3. Where the declarant or the holder of the goods has not confirmed his agreement to the destruction in writing and where the declarant or the holder of the goods has not been deemed to have confirmed his agreement to the destruction, in accordance with point (c) of the first subparagraph of paragraph 1 within the periods referred to therein, the customs authorities shall immediately notify the holder of the decision thereof. The holder of the decision shall, within 10 working days, or three working days in the case of perishable goods, of notification of the suspension of the release or the detention of the goods, initiate proceedings to determine whether an intellectual property right has been infringed. 4. Except in the case of perishable goods the customs authorities may extend the period referred to in paragraph 3 by a maximum of 10 working days upon a duly justified request by the holder of the decision in appropriate cases. 5. The customs authorities shall grant the release of the goods or put an end to their detention, immediately after completion of all customs formalities, where, within the periods referred to in paragraphs 3 and 4, they have not been duly informed, in accordance with paragraph 3, on the initiation of proceedings to determine whether an intellectual property right has been infringed. Article 24 Early release of goods 1. Where the customs authorities have been notified of the initiation of proceedings to determine whether a design, patent, utility model, topography of semiconductor product or plant variety has been infringed, the declarant or the holder of the goods may request the customs authorities to release the goods or put an end to their detention before the completion of those proceedings. 2. The customs authorities shall release the goods or put an end to their detention only where all the following conditions are fulfilled: (a) the declarant or the holder of the goods has provided a guarantee that is of an amount sufficient to protect the interests of the holder of the decision; (b) the authority competent to determine whether an intellectual property right has been infringed has not authorised precautionary measures; (c) all customs formalities have been completed. 3. The provision of the guarantee referred to in point (a) of paragraph 2 shall not affect the other legal remedies available to the holder of the decision. Article 25 Goods for destruction 1. Goods to be destroyed under Article 23 or 26 shall not be: (a) released for free circulation, unless customs authorities, with the agreement of the holder of the decision, decide that it is necessary in the event that the goods are to be recycled or disposed of outside commercial channels, including for awareness-raising, training and educational purposes. The conditions under which the goods can be released for free circulation shall be determined by the customs authorities; (b) brought out of the customs territory of the Union; (c) exported; (d) re-exported; (e) placed under a suspensive procedure; (f) placed in a free zone or free warehouse. 2. The customs authorities may allow the goods referred to in paragraph 1 to be moved under customs supervision between different places within the customs territory of the Union with a view to their destruction under customs control. Article 26 Procedure for the destruction of goods in small consignments 1. This Article shall apply to goods where all of the following conditions are fulfilled: (a) the goods are suspected of being counterfeit or pirated goods; (b) the goods are not perishable goods; (c) the goods are covered by a decision granting an application; (d) the holder of the decision has requested the use of the procedure set out in this Article in the application; (e) the goods are transported in small consignments. 2. When the procedure set out in this Article is applied, Article 17(3) and (4) and Article 19(2) and (3) shall not apply. 3. The customs authorities shall notify the declarant or the holder of the goods of the suspension of the release of the goods or their detention within one working day of the suspension of the release or of the detention of the goods. The notification of the suspension of the release or the detention of the goods shall include the following information: (a) that the customs authorities intend to destroy the goods; (b) the rights of the declarant or the holder of the goods under paragraphs 4, 5 and 6. 4. The declarant or the holder of the goods shall be given the opportunity to express his point of view within 10 working days of notification of the suspension of the release or the detention of the goods. 5. The goods concerned may be destroyed where, within 10 working days of notification of the suspension of the release or the detention of the goods, the declarant or the holder of the goods has confirmed to the customs authorities his agreement to the destruction of the goods. 6. Where the declarant or the holder of the goods has not confirmed his agreement to the destruction of the goods nor notified his opposition thereto to the customs authorities, within the period referred to in paragraph 5, the customs authorities may deem the declarant or the holder of the goods to have confirmed his agreement to the destruction of the goods. 7. The destruction shall be carried out under customs control. The customs authorities shall, upon request and as appropriate, provide the holder of the decision with information about the actual or estimated quantity of destroyed goods and their nature. 8. Where the declarant or the holder of the goods has not confirmed his agreement to the destruction of the goods and where the declarant or the holder of the goods has not been deemed to have confirmed such agreement, in accordance with paragraph 6, the customs authorities shall immediately notify the holder of the decision thereof and of the quantity of goods and their nature, including images thereof, where appropriate. The customs authorities shall also, upon request and where available to them, inform the holder of the decision of the names and addresses of the consignee, the consignor and the declarant or the holder of the goods, of the customs procedure and of the origin, provenance and destination of the goods whose release has been suspended or which have been detained. 9. The customs authorities shall grant the release of the goods or put an end to their detention immediately after completion of all customs formalities where they have not received information from the holder of the decision on the initiation of proceedings to determine whether an intellectual property right has been infringed within 10 working days of the notification referred to in paragraph 8. 10. The Commission shall be empowered to adopt delegated acts in accordance with Article 35 concerning the amendment of quantities in the definition of small consignments in the event that the definition is found to be impractical in the light of the need to ensure the effective operation of the procedure set out in this Article, or where necessary in order to avoid any circumvention of this procedure as regards the composition of consignments. CHAPTER IV LIABILITY, COSTS AND PENALTIES Article 27 Liability of the customs authorities Without prejudice to national law, the decision granting an application shall not entitle the holder of that decision to compensation in the event that goods suspected of infringing an intellectual property right are not detected by a customs office and are released, or no action is taken to detain them. Article 28 Liability of the holder of the decision Where a procedure duly initiated pursuant to this Regulation is discontinued owing to an act or omission on the part of the holder of the decision, where samples taken pursuant to Article 19(2) are either not returned or are damaged and beyond use owing to an act or omission on the part of the holder of the decision, or where the goods in question are subsequently found not to infringe an intellectual property right, the holder of the decision shall be liable towards any holder of the goods or declarant, who has suffered damage in that regard, in accordance with specific applicable legislation. Article 29 Costs 1. Where requested by the customs authorities, the holder of the decision shall reimburse the costs incurred by the customs authorities, or other parties acting on behalf of customs authorities, from the moment of detention or suspension of the release of the goods, including storage and handling of the goods, in accordance with Article 17(1), Article 18(1) and Article 19(2) and (3), and when using corrective measures such as destruction of goods in accordance with Articles 23 and 26. The holder of a decision to whom the suspension of release or detention of goods has been notified shall, upon request, be given information by the customs authorities on where and how those goods are being stored and on the estimated costs of storage referred to in this paragraph. The information on estimated costs may be expressed in terms of time, products, volume, weight or service depending on the circumstances of storage and the nature of the goods. 2. This Article shall be without prejudice to the right of the holder of the decision to seek compensation from the infringer or other persons in accordance with the legislation applicable. 3. The holder of a decision granting a Union application shall provide and pay for any translation required by the competent customs department or customs authorities which are to take action concerning the goods suspected of infringing an intellectual property right. Article 30 Penalties The Member States shall ensure that the holders of decisions comply with the obligations set out in this Regulation, including, where appropriate, by laying down provisions establishing penalties. The penalties provided for shall be effective, proportionate and dissuasive. The Member States shall notify those provisions and any subsequent amendment affecting them to the Commission without delay. CHAPTER V EXCHANGE OF INFORMATION Article 31 Exchange of data on decisions relating to applications and detentions between the Member States and the Commission 1. The competent customs departments shall notify without delay the Commission of the following: (a) decisions granting applications, including the application and its attachments; (b) decisions extending the period during which the customs authorities are to take action or decisions revoking the decision granting the application or amending it; (c) the suspension of a decision granting the application. 2. Without prejudice to point (g) of Article 24 of Regulation (EC) No 515/97, where the release of the goods is suspended or the goods are detained, the customs authorities shall transmit to the Commission any relevant information, except personal data, including information on the quantity and type of the goods, value, intellectual property rights, customs procedures, countries of provenance, origin and destination, and transport routes and means. 3. The transmission of the information referred to in paragraphs 1 and 2 of this Article and all exchanges of data on decisions concerning applications as referred to in Article 14 between customs authorities of the Member States shall be made via a central database of the Commission. The information and data shall be stored in that database. 4. For the purposes of ensuring processing of the information referred to in paragraphs 1 to 3 of this Article, the central database referred to in paragraph 3 shall be established in an electronic form. The central database shall contain the information, including personal data, referred to in Article 6(3), Article 14 and this Article. 5. The customs authorities of the Member States and the Commission shall have access to the information contained in the central database as appropriate for the fulfilment of their legal responsibilities in applying this Regulation. The access to information marked for restricted handling in accordance with Article 6(3) is restricted to the customs authorities of the Member States where action is requested. Upon justified request by the Commission, the customs authorities of the Member States may give access to the Commission to such information where it is strictly necessary for the application of this Regulation. 6. The customs authorities shall introduce into the central database information related to the applications submitted to the competent customs department. The customs authorities which have introduced information into the central database shall, where necessary, amend, supplement, correct or delete such information. Each customs authority that has introduced information in the central database shall be responsible for the accuracy, adequacy and relevancy of this information. 7. The Commission shall establish and maintain adequate technical and organisational arrangements for the reliable and secure operation of the central database. The customs authorities of each Member State shall establish and maintain adequate technical and organisational arrangements to ensure the confidentiality and security of processing with respect to the processing operations carried out by their customs authorities and with respect to terminals of the central database located on the territory of that Member State. Article 32 Establishment of a central database The Commission shall establish the central database referred to in Article 31. That database shall be operational as soon as possible and not later than 1 January 2015. Article 33 Data protection provisions 1. The processing of personal data in the central database of the Commission shall be carried out in accordance with Regulation (EC) No 45/2001 and under the supervision of the European Data Protection Supervisor. 2. Processing of personal data by the competent authorities in the Member States shall be carried out in accordance with Directive 95/46/EC and under the supervision of the public independent authority of the Member State referred to in Article 28 of that Directive. 3. Personal data shall be collected and used solely for the purposes of this Regulation. Personal data so collected shall be accurate and shall be kept up to date. 4. Each customs authority that has introduced personal data into the central database shall be the controller with respect to the processing of this data. 5. A data subject shall have a right of access to the personal data relating to him or her that are processed through the central database and, where appropriate, the right to the rectification, erasure or blocking of personal data in accordance with Regulation (EC) No 45/2001 or the national laws implementing Directive 95/46/EC. 6. All requests for the exercise of the right of access, rectification, erasure or blocking shall be submitted to and processed by the customs authorities. Where a data subject has submitted a request for the exercise of that right to the Commission, the Commission shall forward such request to the customs authorities concerned. 7. Personal data shall not be kept longer than six months from the date the relevant decision granting the application has been revoked or the relevant period during which the customs authorities are to take action has expired. 8. Where the holder of the decision has initiated proceedings in accordance with Article 23(3) or Article 26(9) and has notified the customs authorities of the initiation of such proceedings, personal data shall be kept for six months after proceedings have determined in a final way whether an intellectual property right has been infringed. CHAPTER VI COMMITTEE, DELEGATION AND FINAL PROVISIONS Article 34 Committee procedure 1. The Commission shall be assisted by the Customs Code Committee established by Articles 247a and 248a of Regulation (EEC) No 2913/92. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 35 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 26(10) shall be conferred on the Commission for an indeterminate period of time from 19 July 2013. 3. The delegation of power referred to in Article 26(10) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 26(10) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months on the initiative of the European Parliament or of the Council. Article 36 Mutual administrative assistance The provisions of Regulation (EC) No 515/97 shall apply mutatis mutandis to this Regulation. Article 37 Reporting By 31 December 2016, the Commission shall submit to the European Parliament and to the Council a report on the implementation of this Regulation. If necessary, that report shall be accompanied by appropriate recommendations. That report shall refer to any relevant incidents concerning medicines in transit across the customs territory of the Union that might occur under this Regulation, including an assessment of its potential impact on the Union commitments on access to medicines under the ‘Declaration on the TRIPS Agreement and Public Health’ adopted by the Doha WTO Ministerial Conference on 14 November 2001, and the measures taken to address any situation creating adverse effects in that regard. Article 38 Repeal Regulation (EC) No 1383/2003 is repealed with effect from 1 January 2014. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in the Annex. Article 39 Transitional provisions Applications granted in accordance with Regulation (EC) No 1383/2003 shall remain valid for the period specified in the decision granting the application during which the customs authorities are to take action and shall not be extended. Article 40 Entry into force and application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 1 January 2014, with the exception of: (a) Article 6, Article 12(7) and Article 22(3), which shall apply from 19 July 2013; (b) Article 31(1) and (3) to (7) and Article 33, which shall apply from the date on which the central database referred to in Article 32 is in place. The Commission shall make that date public. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 12 June 2013. For the European Parliament The President M. SCHULZ For the Council The President L. CREIGHTON (1) Position of the European Parliament of 3 July 2012 (not yet published in the Official Journal) and position of the Council at first reading of 16 May 2013 (not yet published in the Official Journal). Position of the European Parliament of 11 June 2013 (not yet published in the Official Journal). (2) OJ L 196, 2.8.2003, p. 7. (3) OJ L 351, 20.12.2012, p. 1. (4) OJ C 45 E, 23.2.2010, p. 47. (5) OJ L 82, 22.3.1997, p. 1. (6) OJ L 281, 23.11.1995, p. 31. (7) OJ L 8, 12.1.2001, p. 1. (8) OJ L 55, 28.2.2011, p. 13. (9) OJ C 363, 13.12.2011, p. 3. (10) OJ L 302, 19.10.1992, p. 1. (11) OJ L 152, 16.6.2009, p. 1. (12) OJ L 198, 8.8.1996, p. 30. (13) OJ L 227, 1.9.1994, p. 1. (14) OJ L 78, 24.3.2009, p. 1. (15) OJ L 3, 5.1.2002, p. 1. (16) OJ L 343, 14.12.2012, p. 1. (17) OJ L 299, 16.11.2007, p. 1. (18) OJ L 149, 14.6.1991, p. 1. (19) OJ L 39, 13.2.2008, p. 16. (20) OJ L 256, 7.9.1987, p. 1. (21) OJ L 157, 30.4.2004, p. 45. (22) OJ L 23, 26.1.2008, p. 21. ANNEX Correlation table Regulation (EC) No 1383/2003 This Regulation Article 1 Article 1 Article 2 Article 2 Article 3 Article 1 Article 4 Article 18 Article 5 Articles 3 to 9 Article 6 Articles 6 and 29 Article 7 Article 12 Article 8 Articles 10, 11, 12, 14 and 15 Article 9 Articles 17 and 19 Article 10 — Article 11 Article 23 Article 12 Articles 16 and 21 Article 13 Article 23 Article 14 Article 24 Article 15 Article 20 Article 16 Article 25 Article 17 — Article 18 Article 30 Article 19 Articles 27 and 28 Article 20 Articles 6, 12, 22 and 26 Article 21 Article 34 Article 22 Articles 31 and 36 Article 23 — Article 24 Article 38 Article 25 Article 40

Intellectual property rights — customs enforcement Intellectual property rights — customs enforcement SUMMARY OF: Regulation (EU) No 608/2013 on customs enforcement of intellectual property rights WHAT IS THE AIM OF THE REGULATION? The regulation provides revised procedural rules for customs authorities to enforce intellectual property rights (IPR) on goods liable to customs supervision or customs control. It replaces Regulation (EC) No 1383/2003. KEY POINTS This regulation particularly covers goods in the following situations: when declared for release for free circulation, export or re-export; when entering or leaving the customs territory of the EU; when the goods are suspended from customs clearance or are in a free zone or free warehouse*. It sets out procedures for applications to determine whether an IPR has been infringed. For the purposes of the regulation, an IPR could include: a trade mark; a design; a copyright under national or EU law; a geographical indication (such as Champagne or Parma ham); a patent under national or EU law; a supplementary protection certificate for medicinal products; a supplementary protection certificate for pesticides; an plant variety right under national or EU law; a semiconductor product design under national or EU law; an IPR that protects inventions under national or EU law; a trade name protected as an exclusive IPR under national or EU law. The regulation: sets out the conditions for customs action where goods are merely suspected of infringing IPRs; sets out measures to be taken against goods that have been found to infringe IPRs; expands the range of IPR infringements covered and reinforces the competence of customs authorities to control all goods under customs supervision — this does not apply to non-commercial goods in travellers’ personal luggage; ensures that high-quality information is provided to customs to enable a comprehensive assessment of the risk of IPR infringement; sets out the legal basis for a central database for recording the applications for customs action and detentions of IPR-infringing goods as well as the exchange of information between customs authorities. To reduce administrative burden, the regulation: sets out a common procedure for all kinds of IPR infringements falling within the scope of the regulation, under which goods may be destroyed without the need for the rightsholder to initiate legal proceedings, on condition that: the rightsholder confirms in writing that in their conviction there is an infringement and that they agree to their destruction, andthe declarant or holder of the goods does not object to destruction; states that the procedure for small consignments applies only on prior request from the applicant and that the customs authorities may require the applicant to cover the costs — a small consignment is defined as a postal or express courier consignment, which either contains three units or fewer or weighs less than 2 kg. In addition, the regulation: stipulates that national laws apply when granting the right to be heard of the persons concerned by the detention of goods; broadens and clarifies the cases where the rightsholder may use the information that customs disclose following a detention of goods; includes rules on data collection, processing, data retention periods and the exercise of rights and responsibilities in relation to existing legislation on data protection. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2014, with some exceptions. BACKGROUND A Commission notice relates to the trade mark package adopted in 2015: Part 1: although Regulation (EU) 2015/2424 amended Council Regulation (EC) No 207/2009 (as cited in the Commission notice), the latter was subsequently repealed and replaced by Regulation (EU) 2017/1001 — which is a codification; Part 2: relates to Directive (EU) 2015/2436 See also: ‘Enforcement of intellectual property rights’ (European Commission) ‘Counterfeit, piracy and other IPR violations’ (European Commission). KEY TERMS Free zone or warehouse: special area or warehouse within the customs territory of the EU which is exempt from custom duties. For more information, please check the relevant list. MAIN DOCUMENT Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, pp. 15-34) RELATED DOCUMENTS Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (codification) (OJ L 154, 16.6.2017, pp. 1-99) Commission notice on the customs enforcement of Intellectual Property Rights concerning goods brought into the customs territory of the Union without being released for free circulation including goods in transit (OJ C 244, 5.7.2016, pp. 4-9) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (general data protection regulation) (OJ L 119, 4.5.2016, pp. 1-88) Successive amendments to Regulation (EU) No 2016/679 have been incorporated into the original text. This consolidated version is of documentary value only. Directive (EU) 2015/2436 of the European Parliament and of the Council of 16 December 2015 to approximate the laws of the Member States relating to trade marks (recast) (OJ L 336, 23.12.2015, pp. 1-26) See consolidated version. Council resolution of 25 September 2008 on a comprehensive European anti-counterfeiting and anti-piracy plan (OJ C 253, 4.10.2008, pp. 1-2) Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L 157, 30.4.2004, pp. 45-86). Text republished in corrigendum (OJ L 195, 2.6.2004, pp. 16-25) See consolidated version. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions — A single market for intellectual property rights: boosting creativity and innovation to provide economic growth, high-quality jobs and first-class products and services in Europe (COM(2011) 287 final, 24.5.2011) last update 08.12.2017

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13.7.2021 EN Official Journal of the European Union L 247/1 REGULATION (EU) 2021/1139 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 July 2021 establishing the European Maritime, Fisheries and Aquaculture Fund and amending Regulation (EU) 2017/1004 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 42, Article 43(2), Article 91(1), Article 100(2), Article 173(3), Article 175, Article 188, Article 192(1), Article 194(2), Article 195(2) and Article 349 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The European Maritime, Fisheries and Aquaculture Fund (the ‘EMFAF’) should be established for the period from 1 January 2021 to 31 December 2027 in order to align its duration with that of the multiannual financial framework (the ‘MFF 2021-2027’) laid down in Council Regulation (EU, Euratom) 2020/2093 (4). This Regulation should lay down the priorities of the EMFAF, its budget and the specific rules for providing Union funding, complementing the general rules applicable to the EMFAF under Regulation (EU) 2021/1060 of the European Parliament and of the Council (5). The EMFAF should aim to channel funding from the Union budget to support the Common Fisheries Policy (CFP), the Union’s maritime policy and the Union’s international commitments in the field of ocean governance. Such funding is a key enabler for sustainable fisheries and the conservation of marine biological resources, for food security through the supply of seafood products, for the growth of a sustainable blue economy and for healthy, safe, secure, clean and sustainably managed seas and oceans. (2) As a global ocean actor and one of the world’s largest producers of seafood, the Union has a strong responsibility to protect, conserve and sustainably use the oceans and their resources. Indeed, preserving seas and oceans is vital for a rapidly growing world population. It is also of socio-economic interest for the Union as a sustainable blue economy boosts investments, jobs and growth, fosters research and innovation and contributes to energy security through ocean energy. Moreover, efficient border control and the global fight against maritime crime are essential for safe and secure seas and oceans, thereby addressing citizens’ security concerns. (3) Regulation (EU) 2021/1060 has been adopted in order to improve the coordination and harmonise the implementation of support from Funds under shared management (the ‘Funds’), with the main aim of simplifying policy delivery in a coherent way. That Regulation applies to the part of the EMFAF under shared management. The Funds pursue complementary objectives and share the same management mode. Therefore, Regulation (EU) 2021/1060 sets out a series of common general objectives and general principles such as partnership and multi-level governance. It also contains the common elements of strategic planning and programming, including provisions on the Partnership Agreement to be concluded with each Member State, and sets out a common approach to the performance orientation of the Funds. Accordingly, it sets out enabling conditions, a performance review and arrangements for monitoring, reporting and evaluation. Furthermore, it sets out common provisions with regard to eligibility rules, and special arrangements are established for financial instruments, for the use of InvestEU established by Regulation (EU) 2021/523 of the European Parliament and of the Council (6), for community-led local development (CLLD) and for financial management. Some management and control arrangements are also common to all the Funds. Complementarities between the Funds, including the EMFAF, and other Union programmes should be described in the Partnership Agreement, in accordance with Regulation (EU) 2021/1060. (4) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (7) (the ‘Financial Regulation’) applies to the EMFAF. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (5) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 of the Treaty on the Functioning of the European Union (TFEU) apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, prizes, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (6) Under direct management, the EMFAF should develop synergies and complementarities with other relevant Union funds and programmes. It should also allow financing in the form of financial instruments within blending operations implemented under Regulation (EU) 2021/523. (7) Support under the EMFAF should have a clear European added value, inter alia, by addressing market failures or suboptimal investment situations in a proportionate manner, and should not duplicate or crowd out private financing or distort competition in the internal market. (8) Articles 107, 108 and 109 TFEU should apply to the aid granted by Member States to undertakings in the fishery and aquaculture sector under this Regulation. Nevertheless, given the specific characteristics of that sector, those Articles should not apply to payments made by Member States pursuant to this Regulation and falling within the scope of Article 42 TFEU. (9) The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the priorities set for the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. This should include consideration of the use of lump sums, flat rates and unit costs, as well as financing not linked to costs as referred to in Article 125(1) of the Financial Regulation. (10) The MFF 2021-2027 provides that the Union budget is to continue to support fisheries and maritime policies. The EMFAF budget should amount, in current prices, to EUR 6 108 000 000. EMFAF resources should be split between shared management and direct and indirect management. EUR 5 311 000 000 should be allocated to support under shared management and EUR 797 000 000 to support under direct and indirect management. In order to ensure stability, in particular with regard to the achievement of the objectives of the CFP, the definition of national allocations under shared management for the 2021-2027 programming period should be based on the 2014-2020 shares under Regulation (EU) No 508/2014 of the European Parliament and of the Council on the European Maritime and Fisheries Fund (8) (the ‘EMFF’). Specific amounts should be reserved for the outermost regions, for control and enforcement, and for collection and processing of data for fisheries management and scientific purposes, while amounts for certain investments in fishing vessels and for permanent and temporary cessation of fishing activities should be capped. (11) Europe’s maritime sector employs over 5 million people, generating almost EUR 750 000 000 000 in turnover and EUR 218 000 000 000 in gross added value per year, with a potential to create many more jobs. The output of the global ocean economy is estimated at EUR 1 300 000 000 000 today and this could more than double by 2030. The need to meet CO2 emission targets, increase resource efficiency and reduce the environmental footprint of the blue economy has been a significant driving force for innovation in other sectors such as marine equipment, shipbuilding, ocean observation, dredging, coastal protection and marine construction. Investment in the maritime economy has been provided through Union structural funds, in particular the European Regional Development Fund (ERDF) and the EMFAF. New investment tools such as InvestEU could be utilised to meet the growth potential of the maritime sector. (12) The EMFAF should be based on four priorities: fostering sustainable fisheries and the restoration and conservation of aquatic biological resources; fostering sustainable aquaculture activities, and processing and marketing of fishery and aquaculture products, thus contributing to food security in the Union; enabling a sustainable blue economy in coastal, island and inland areas, and fostering the development of fishing and aquaculture communities; strengthening international ocean governance and enabling seas and oceans to be safe, secure, clean and sustainably managed. Those priorities should be pursued through shared, direct and indirect management. (13) The EMFAF should be based on a simple architecture without predefining measures and detailed eligibility rules at Union level in an overly prescriptive manner. Instead, broad specific objectives should be described under each priority. Member States should therefore prepare their programmes indicating therein the most appropriate means for achieving those objectives. A variety of measures identified by the Member States in those programmes might be supported under the rules set out in this Regulation and Regulation (EU) 2021/1060, provided they are covered by the specific objectives identified in this Regulation. However, it is necessary to set out a list of ineligible operations so as to avoid detrimental impact in terms of fisheries conservation. Moreover, investments and compensation for the fleet should be strictly conditional upon their consistency with the conservation objectives of the CFP. (14) The United Nations 2030 Agenda for Sustainable Development (the ‘2030 Agenda’) identified conservation and sustainable use of oceans as one of the 17 Sustainable Development Goals (SDGs), namely SDG 14 (‘Conserve and sustainably use the oceans, seas and marine resources for sustainable development’). The Union is fully committed to that goal and its implementation. In that context, it has committed to promote a sustainable blue economy which is consistent with maritime spatial planning, the conservation of biological resources and the achievement of a good environmental status as set out in Directive 2008/56/EC of the European Parliament and of the Council (9), as well as to prohibit certain forms of fisheries subsidies which contribute to overcapacity and overfishing, to eliminate subsidies that contribute to illegal, unreported and unregulated (IUU) fishing and to refrain from introducing new such subsidies. The latter outcome should result from the negotiations within the World Trade Organisation (WTO) on fisheries subsidies. In addition, in the course of the WTO negotiations at the 2002 World Summit of Sustainable Development and at the 2012 United Nations Conference on Sustainable Development (Rio+20), the Union has committed to eliminate subsidies contributing to fisheries overcapacity and overfishing. (15) Reflecting the importance of tackling climate change in line with the Union’s commitments to implement the Paris Agreement, and the commitment to the United Nations Sustainable Development Goals, the actions under this Regulation should contribute to the achievement of a 30 % target of all expenditure under the MFF 2021-2027 spent on mainstreaming climate objectives and should contribute to the ambition of providing 7,5 % of annual spending under the MFF 2021-2027 to biodiversity objectives in 2024 and 10 % of annual spending under the MFF 2021-2027 to biodiversity objectives in 2026 and 2027, while considering the existing overlaps between climate and biodiversity goals. (16) The EMFAF should contribute to the achievement of the environmental and climate change mitigation and adaptation objectives of the Union. That contribution should be tracked through the application of Union environmental and climate markers and reported regularly in accordance with Regulation (EU) 2021/1060. (17) In accordance with Article 42 of Regulation (EU) No 1380/2013 of the European Parliament and of the Council (10), Union financial assistance under the EMFAF should be conditional upon compliance with the rules of the CFP. Applications from operators that have committed serious infringements of the rules of the CFP should not be admissible. (18) In order to address the specific conditions of the CFP referred to in Regulation (EU) No 1380/2013 and to contribute to compliance with the rules of the CFP, provisions additional to the rules on interruption, suspension and financial corrections as set out in Regulation (EU) 2021/1060 should be laid down. Where a Member State has failed to comply with its obligations under the CFP, or where the Commission has evidence that suggests such lack of compliance, the Commission should, as a precautionary measure, be allowed to interrupt payment deadlines. In addition to the possibility of interruption of the payment deadline, and in order to avoid an evident risk of paying out ineligible expenditure, the Commission should be allowed to suspend payments and impose financial corrections in cases of serious non-compliance with the rules of the CFP by a Member State. (19) Steps have been taken over the last few years towards bringing fish stocks back to healthy levels, towards increasing the profitability of the Union’s fishing industry and towards conserving marine ecosystems. However, substantial challenges remain to fully achieve the socio-economic and environmental objectives of the CFP, in particular the objectives of restoring and maintaining populations of harvested species above levels which can produce the maximum sustainable yield (MSY), of eliminating unwanted catches and of establishing fish stock recovery areas. Achieving those objectives requires continued support beyond 2020, particularly in sea basins where progress has been slower. (20) The EMFAF should contribute to achieving the environmental, economic, social and employment objectives of the CFP, as set out in Article 2 of Regulation (EU) No 1380/2013, in particular the objectives of restoring and maintaining populations of harvested species above levels which can produce MSY, of avoiding and reducing, as far as possible, unwanted catches and of minimising the negative impact of fishing activities on the marine ecosystem. Such support should ensure that fishing activities are environmentally sustainable in the long term and are managed in a way that is consistent with the objectives set out in Article 2 of Regulation (EU) No 1380/2013, with a view to achieving economic, social and employment benefits, contributing to the availability of healthy food supplies and contributing to a fair standard of living for those who depend on fishing activities, bearing in mind coastal fisheries and socio-economic aspects. That support should include innovation and investments in low-impact, selective, climate-resilient and low-carbon fishing practices and techniques. (21) Fisheries are vital to the livelihood and cultural heritage of many coastal communities in the Union, in particular where small-scale coastal fishing plays an important role. With the average age in many fishing communities being over 50, generational renewal and diversification of activities remain a challenge. In particular, the creation and development of new economic activities in the fisheries sector by young fishers is financially challenging and constitutes an element that should be considered in the allocation and targeting of funds under the EMFAF. Such development is essential for the competitiveness of the fisheries sector in the Union. Consequently, support for young fishers starting up fishing activities should be made available in order to facilitate their establishment. In order to ensure the viability of new economic activities supported under the EMFAF, support should be made conditional upon the acquisition of adequate experience or qualifications. Where support for business start-up is granted for the acquisition of a fishing vessel, it should only contribute to the acquisition of the first fishing vessel or of a controlling share thereof. (22) Avoiding unwanted catches is one of the main challenges of the CFP. In that respect, the legal obligation to land all catches has entailed significant and important changes in fishing practices for the sector, sometimes with an important financial cost. It should therefore be possible for the EMFAF to support innovation and investments that contribute to the full implementation of the landing obligation, as well as the development and implementation of conservation measures contributing to selectivity. It should be possible to grant a higher aid intensity rate to investments in selective fishing gear, in the improvement of port infrastructures and in the marketing of unwanted catches, than the one that applies to other operations. It should also be possible to grant a maximum aid intensity rate of 100 % to the design, development, monitoring, evaluation and management of transparent systems for exchanging fishing opportunities between Member States (‘quota swaps’), in order to mitigate the ‘choke species’ effect caused by the landing obligation. (23) It should be possible for the EMFAF to support innovation and investments on board Union fishing vessels. That support should include actions which aim to improve health, safety and working conditions, energy efficiency and the quality of catches. It should not include the acquisition of equipment that increases the ability of a fishing vessel to find fish. Such support should also not lead to an increase in fishing capacity of any individual vessel, except if it directly results from an increase in gross tonnage of a fishing vessel that is necessary for improving safety, working conditions or energy efficiency. In those cases, the increase in fishing capacity of the individual vessel should be compensated for by the prior withdrawal of at least the same amount of fishing capacity without public aid from the same fleet segment or from a fleet segment where the fishing capacity is not in balance with the available fishing opportunities, in order not to lead to any increase in fishing capacity at fleet level. Moreover, support should not be granted simply for complying with requirements that are obligatory under Union law, with the exception of requirements imposed by a Member State to give effect to optional provisions under Council Directive (EU) 2017/159 (11) and in relation to the purchase, installation and management of certain equipment for control purposes. Under an architecture without prescriptive measures, it should be up to Member States to lay down the precise eligibility rules for those investments. With regard to health, safety and working conditions on board fishing vessels, a higher aid intensity rate than the one that applies to other operations should be allowed. (24) It is necessary to establish specific eligibility rules for certain other investments supported by the EMFAF in the fishing fleet, so as to prevent those investments from contributing to overcapacity or overfishing. In particular, support for the first acquisition of a second-hand vessel by a young fisher and for the replacement or the modernisation of the engine of a fishing vessel should also be subject to conditions, including that the vessel belongs to a fleet segment which is in balance with the fishing opportunities available to that segment and that the new or modernised engine does not have more power in kilowatts (kW) than that of the engine being replaced. (25) Investment in human capital plays an essential role in the competitiveness and economic performance of the fishery, aquaculture and maritime sectors. Therefore, it should be possible for the EMFAF to support advisory services, cooperation between scientists and fishers, professional training, lifelong learning, as well as the promotion of social dialogue and the dissemination of knowledge. (26) Fisheries control is of the utmost importance for the implementation of the CFP. Therefore, the EMFAF should support, under shared management, the development and implementation of a Union fisheries control system as set out in Council Regulation (EC) No 1224/2009 (12). Certain obligations established in that Regulation justify specific support from the EMFAF, namely compulsory vessel tracking and electronic reporting systems, compulsory remote electronic monitoring systems and the compulsory continuous measurement and recording of propulsive engine power. In addition, investments by Member States in control assets could also be used for the purposes of maritime surveillance and cooperation on coast guard functions. (27) The success of the CFP is dependent on the availability of scientific advice for the management of fisheries, and hence on the availability of data on fisheries. In the light of the challenges and costs of obtaining reliable and complete data, it is necessary to support Member States’ actions to collect and process data in line with Regulation (EU) 2017/1004 of the European Parliament and of the Council (13) and to contribute to the best available scientific advice. That support should allow synergies with the collection and processing of other types of marine data. (28) The EMFAF should support an effective knowledge-based implementation and governance of the CFP under direct and indirect management through the provision of scientific advice, regional cooperation on conservation measures, the development and implementation of a Union fisheries control system, the functioning of Advisory Councils and voluntary contributions to international organisations. (29) In order to strengthen economically, socially and environmentally sustainable fishing activities, it should be possible for the EMFAF to support operations for the management of fisheries and fishing fleets in accordance with Articles 22 and 23 of, and Annex II to, Regulation (EU) No 1380/2013, as well as efforts by Member States to optimise the allocation of their available fishing capacity, taking into account the needs of their fleet, and without increasing their overall fishing capacity. (30) Given the challenges of achieving the conservation objectives of the CFP, support for fleet adaptation remains sometimes necessary with regard to certain fleet segments and sea basins. Such support should be tightly targeted to better fleet management and to the conservation and sustainable exploitation of marine biological resources, and aimed at achieving a balance between the fishing capacity and the available fishing opportunities. Therefore, it should be possible for the EMFAF to support the permanent cessation of fishing activities in fleet segments where the fishing capacity is not balanced with the available fishing opportunities. Such support should be a tool of the action plans for the adjustment of fleet segments with identified structural overcapacity, as provided for in Article 22(4) of Regulation (EU) No 1380/2013, and should be implemented either through the scrapping of the fishing vessel or through its decommissioning and retrofitting for other activities. Where the retrofitting would lead to an increased pressure of recreational fishing on the marine ecosystem, support should only be granted if it is in line with the CFP and with the objectives of the relevant multiannual plans. (31) In order to contribute to the conservation objectives of the CFP or to mitigate certain exceptional circumstances, it should be possible for the EMFAF to support compensation for the temporary cessation of fishing activities caused by the implementation of certain conservation measures, by the implementation of emergency measures, by the interruption, due to reasons of force majeure, of the application of a sustainable fisheries partnership agreement (SFPA), by a natural disaster, by an environmental incident or by a health crisis. Support in the event of temporary cessation caused by conservation measures should be granted only where, based on scientific advice, a reduction of fishing effort is needed in order to achieve the objectives set out in Article 2(2) and point (a) of Article 2(5) of Regulation (EU) No 1380/2013. (32) Given that fishers are exposed to increasing economic and environmental risks, inter alia due to climate change and price volatility, it should be possible for the EMFAF to support actions that strengthen the resilience of the fisheries sector, including through mutual funds, insurance instruments or other collective schemes which enhance the capacity of the sector to manage risks and respond to adverse events. (33) Small-scale coastal fishing is carried out by marine and inland fishing vessels of an overall length of less than 12 metres and not using towed fishing gear, and by fishers on foot, including shellfish gatherers. That sector represents nearly 75 % of all fishing vessels registered in the Union and nearly half of all employment in the fisheries sector. Operators from small-scale coastal fisheries are particularly dependent on healthy fish stocks for their main source of income. With the aim of encouraging sustainable fishing practice, the EMFAF should therefore give those operators preferential treatment, through a maximum 100 % aid intensity rate, except for operations relating to the first acquisition of a fishing vessel, the replacement or modernisation of an engine and operations that increase the gross tonnage of a fishing vessel for the purposes of improving safety, working conditions or energy efficiency. In addition, Member States should take into account in their programme the specific needs of small-scale coastal fishing and describe the types of actions considered for the development of small-scale coastal fishing. (34) The maximum EMFAF co-financing rate per specific objective should be 70 % of the eligible public expenditure, with the exception of compensation for additional costs in the outermost regions, for which it should be 100 %. (35) The maximum aid intensity rate should be 50 % of the total eligible expenditure, with the possibility, in certain cases, to set derogatory rates. (36) The outermost regions face specific challenges linked to their remoteness, topography and climate as referred to in Article 349 TFEU and also have specific assets on which to develop a sustainable blue economy. Therefore, for each outermost region, an action plan for the development of sustainable blue economy sectors, including sustainable fisheries and aquaculture, should be attached to the programme of the Member States concerned, and a financial allocation should be reserved to support the implementation of those action plans. It should also be possible for the EMFAF to support compensation for the additional costs which the operators from the outermost regions face due to the location or insularity of those regions. That support should be capped as a percentage of that overall financial allocation. In addition, a higher aid intensity rate than the one that applies to other operations should be applied in the outermost regions. It should be possible for Member States to grant additional financing for the implementation of that support. As State aid, such financing should be notified to the Commission, which may approve it under this Regulation as part of that support. (37) Under shared management, it should be possible for the EMFAF to support the protection and restoration of aquatic biodiversity and ecosystems, including in inland waters. For that purpose, support from the EMFAF should be available to compensate, inter alia, the passive collection by fishers of lost fishing gear and marine litter from the sea, including sargassum seaweed, and for investments in ports to provide adequate reception facilities for lost fishing gear and marine litter. Support should also be available for actions to achieve or maintain a good environmental status in the marine environment as set out in Directive 2008/56/EC, for the implementation of spatial protection measures established pursuant to that Directive, for the management, restoration and monitoring of Natura 2000 areas, in accordance with the prioritised action frameworks established pursuant to Council Directive 92/43/EEC (14), for the protection of species, in particular under Directive 92/43/EEC and Directive 2009/147/EC of the European Parliament and of the Council (15), as well as for the restoration of inland waters in accordance with the programme of measures established pursuant to Directive 2000/60/EC of the European Parliament and of the Council (16). Under direct management, the EMFAF should support the promotion of clean and healthy seas and the implementation of the European strategy for plastics in a circular economy developed in the Communication of the Commission of 16 January 2018, in line with the objective of achieving or maintaining a good environmental status in the marine environment. (38) Fisheries and aquaculture contribute to food security and nutrition. However, it is estimated that the Union currently imports more than 60 % of its supply of fishery products and is therefore highly dependent on third countries. An important challenge is to encourage the consumption of fish protein produced in the Union with high quality standards and available for consumers at affordable prices. (39) It should be possible for the EMFAF to support the promotion and the sustainable development of aquaculture, including freshwater aquaculture, for the farming of aquatic animals and plants for the production of food and other raw material. Complex administrative procedures in some Member States remain in place, such as difficult access to space and burdensome licensing procedures, which make it difficult for the sector to improve the image and competitiveness of farmed products. Support from the EMFAF should be consistent with the multiannual national strategic plans for aquaculture developed on the basis of Regulation (EU) No 1380/2013. In particular, support for environmental sustainability, productive investments, innovation, acquisition of professional skills, improvement of working conditions, and compensatory measures providing critical land and nature management services should be eligible. Public health actions, aquaculture stock insurance schemes and animal health and welfare actions should also be eligible. (40) Food security relies on efficient and well-organised markets, which improve the transparency, stability, quality and diversity of the supply chain, as well as consumer information. For that purpose, it should be possible for the EMFAF to support the marketing of fishery and aquaculture products, in line with the objectives set out in Regulation (EU) No 1379/2013 of the European Parliament and of the Council (17). In particular, support should be available for the creation of producer organisations, the implementation of production and marketing plans, the promotion of new market outlets and the development and dissemination of market intelligence. (41) The processing industry plays a role in the availability and quality of fishery and aquaculture products. It should be possible for the EMFAF to support targeted investments in that industry, provided that they contribute to the achievement of the objectives of the common organisation of the markets. For enterprises other than small and medium-sized enterprises (SMEs), such support should be provided only through financial instruments or through InvestEU and not through grants. (42) It should be possible for the EMFAF to support compensation to operators of the fishery and aquaculture sector in the case of exceptional events causing a significant disruption of markets. (43) Job creation in coastal regions relies on the locally driven development of a sustainable blue economy that revives the social fabric of those regions. Ocean industries and services are likely to outperform the growth of the global economy and make an important contribution to employment and growth by 2030. To be sustainable, blue growth depends on innovation and investment in new maritime businesses and in the bio-economy, including sustainable tourism models, ocean-based renewable energy, innovative high-end shipbuilding and new port services, which can create jobs and at the same time enhance local development. While public investment in the sustainable blue economy should be mainstreamed throughout the Union budget, the support from the EMFAF should specifically be focused on enabling conditions for the development of the sustainable blue economy and on removing bottlenecks to facilitate investment and the development of new markets, technologies or services. Support for the development of the sustainable blue economy should be delivered through shared, direct and indirect management. (44) The development of a sustainable blue economy strongly relies on partnerships between local stakeholders that contribute to the vitality of coastal and inland communities and economies. The EMFAF should provide tools to foster such partnerships. For that purpose, support through CLLD should be available under shared management. That approach should boost economic diversification in a local context through the development of coastal and inland fisheries, aquaculture and a sustainable blue economy. CLLD strategies should ensure that local communities in fishing and aquaculture areas better exploit and benefit from the opportunities offered by the sustainable blue economy, capitalising on and strengthening environmental, cultural, social and human resources. Every local partnership should therefore reflect the main focus of its strategy by ensuring a balanced involvement and representation of all relevant stakeholders from the local sustainable blue economy. (45) Under shared management, it should be possible for the EMFAF to support the strengthening of sustainable sea and ocean management through the collection, management and use of data to improve the knowledge on the state of the marine environment. That support should aim to fulfil requirements under Directives 92/43/EEC and 2009/147/EC, to support maritime spatial planning and to increase data quality and sharing through the European marine observation and data network. (46) Under direct and indirect management, support from the EMFAF should focus on the enabling conditions for a sustainable blue economy through the promotion of an integrated governance and management of the maritime policy, the enhancement of the transfer and uptake of research, innovation and technology in the sustainable blue economy, the improvement of maritime skills, ocean literacy and sharing of socio-economic data on the sustainable blue economy, the promotion of a low-carbon and climate-resilient sustainable blue economy, and the development of project pipelines and innovative financing instruments. Due consideration to the outermost regions’ specific situation should be given in relation to the above-mentioned fields. (47) 60 % of the oceans are beyond the borders of national jurisdiction. This implies a shared international responsibility. Most problems facing the oceans, such as overexploitation, climate change, acidification, pollution and declining biodiversity, are transboundary in nature and therefore require a shared response. Under the United Nations Convention on the Law of the Sea, to which the Union is a Party under Council Decision 98/392/EC (18), many jurisdictional rights, institutions and specific frameworks have been set up to regulate and manage human activity in the oceans. In recent years, a global consensus has emerged that the marine environment and maritime human activities should be managed more effectively to address the increasing pressures on the oceans. (48) As a global actor, the Union is strongly committed to promoting international ocean governance, in accordance with the Joint Communication of the Commission and the High Representative of the Union for Foreign Affairs and Security Policy of 10 November 2016 entitled ‘International ocean governance: an agenda for the future of our oceans’. The Union’s ocean governance policy covers the oceans in an integrated manner. International ocean governance is not only core to the achievement of the ‘2030 Agenda’, and in particular SDG 14, but also to guarantee safe, secure, clean and sustainably managed seas and oceans for future generations. The Union needs to deliver on those international commitments and be a driving force for better international ocean governance at bilateral, regional and multilateral levels, including to prevent, deter and eliminate IUU fishing, to improve the international ocean governance framework, to reduce pressures on oceans and seas, to create the conditions for a sustainable blue economy and to strengthen international ocean research and data. (49) Actions promoting international ocean governance under the EMFAF are aimed to improve the overarching framework of international and regional processes, agreements, rules and institutions to regulate and manage human activity in the oceans. The EMFAF should support international arrangements that the Union has concluded in areas not covered by the SFPAs established with various third countries, as well as the Union’s mandatory membership contribution to regional fisheries management organisations (RFMOs). SFPAs and RFMOs will continue to be funded under different strands of the Union budget. (50) With regard to security and defence, improved border protection and maritime security are essential. Under the European Union Maritime Security Strategy adopted by the Council of the European Union on 24 June 2014 and its Action Plan adopted on 16 December 2014, information sharing and the European border and coast guard cooperation between the European Fisheries Control Agency, the European Maritime Safety Agency and the European Border and Coast Guard Agency are key to deliver on those objectives. The EMFAF should therefore support maritime surveillance and coast guard cooperation under both shared and direct management, including by purchasing items for multipurpose maritime operations. It should also allow the relevant agencies to implement support in the field of maritime surveillance and security through indirect management. (51) Under shared management, each Member State should prepare a single programme that should be approved by the Commission. The Commission should assess the draft programmes by taking into account the maximisation of their contribution to the priorities of the EMFAF and to the objectives of resilience, green transition and digital transition. When assessing the draft programmes, the Commission should also take into account their contribution to the development of sustainable small-scale coastal fishing, to environmental, economic and social sustainability, to meeting the environmental and socio-economic challenges of the CFP, to the socio-economic performance of the sustainable blue economy, to the conservation and restoration of marine ecosystems, to the reduction of marine litter and to the mitigation of, and adaptation to, climate change. (52) In the context of regionalisation and with a view to encouraging Member States to have a strategic approach during the preparation of programmes, the Commission should assess the draft programmes by taking into account, where applicable, the regional sea basin analysis developed by the Commission indicating the common strengths and weaknesses with regard to the achievement of the objectives of the CFP. That analysis should guide both the Member States and the Commission in negotiating each programme, taking into account regional challenges and needs. (53) The performance of the EMFAF in Member States should be assessed on the basis of indicators. Member States should report on progress towards established milestones and targets in accordance with Regulation (EU) 2021/1060. A monitoring and evaluation framework should be established for that purpose. (54) For the purposes of providing information on the support from the EMFAF for environmental and climate objectives in accordance with Regulation (EU) 2021/1060, a methodology based on types of intervention should be established. That methodology should consist of assigning a specific weighting to the support provided at a level which reflects the extent to which such support makes a contribution to environmental objectives and to climate objectives. (55) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (19), the EMFAF should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators, as a basis for evaluating the effects of the EMFAF on the ground. (56) The Commission should implement information and communication actions relating to the EMFAF, and its actions and results. Financial resources allocated to the EMFAF should also contribute to the corporate communication of the political priorities of the Union, insofar as they are related to the priorities of the EMFAF. (57) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (20), Council Regulation (Euratom, EC) No 2988/95 (21), Council Regulation (Euratom, EC) No 2185/96 (22) and Council Regulation (EU) 2017/1939 (23), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor’s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (24). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. Member States should prevent, detect and deal effectively with any irregularities, including fraud, committed by beneficiaries. Member States should report to the Commission any irregularities detected, including fraud, and any follow-up action they have taken with regard to such irregularities and with regard to any OLAF investigations. (58) In order to enhance transparency regarding the use of Union funds and their sound financial management, in particular reinforcing public control of the money used, certain information on the operations funded under the EMFAF should be published on a website of a Member State, in accordance with Regulation (EU) 2021/1060. When a Member State publishes information on operations funded under EMFAF, the rules on the protection of personal data set out in Regulation (EU) 2016/679 of the European Parliament and of the Council (25) are to be complied with. (59) In order to supplement certain non-essential elements of this Regulation, the power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the identification of the threshold triggering, and the period of time of, inadmissibility with regard to the admissibility criteria of applications, in respect of the arrangements for recovering the aid granted in the event of serious infringements, in respect of the relevant starting or ending dates of the inadmissibility period and the conditions for a reduced period of inadmissibility and in respect of the definition of criteria for the calculation of the additional costs resulting from the specific handicaps of the outermost regions. In order to amend certain non-essential elements of this Regulation, the power to adopt delegated acts in accordance with Article 290 TFEU should also be delegated to the Commission in order to allow for the introduction of additional core performance indicators. In order to facilitate a smooth transition from the scheme established by Regulation (EU) No 508/2014 to the scheme established by this Regulation, the power to adopt delegated acts in accordance with Article 290 TFEU should also be delegated to the Commission in order to supplement this Regulation by establishing transitional provisions. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (60) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of the work programmes, the identification of energy-efficient technologies and the establishment of the methodological elements to measure CO2 emission reductions of fishing vessel engines, the occurrence of an exceptional event, the definition of the cases of non-compliance by Member States which can trigger an interruption of the payment deadline, the suspension of payments due to serious non-compliance by a Member State, financial corrections and the identification of relevant operation-level implementation data and their presentation. Except as regards the work programmes, including technical assistance, and the occurrence of an exceptional event, those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (26). (61) In accordance with Article 193(2) of the Financial Regulation, it should be possible for a grant to be awarded for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to signature of the grant agreement. However, the costs incurred prior to the date of submission of the grant application are not eligible, except in duly justified exceptional cases. In order to avoid any disruption in Union support which could be prejudicial to Union’s interests, it should be possible to provide in the financing decision, during a limited period of time at the beginning of the MFF 2021-2027, and only in duly justified cases, for eligibility of activities and costs from the beginning of the 2021 financial year, even if they were implemented and incurred before the grant application was submitted. For the same reasons and under the same conditions, it is necessary to derogate from Article 193(4) of the Financial Regulation as regards operating grants. (62) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of their scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (63) In order to ensure continuity in providing support in the relevant policy area and to allow implementation as of the beginning of the MFF 2021-2027, it is necessary to provide for the application of this Regulation, with retroactive effect, as regards the support under direct and indirect management from 1 January 2021. Consequently, this Regulation should enter into force as a matter of urgency on the day following that of its publication in the Official Journal of the European Union, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL FRAMEWORK CHAPTER I General provisions Article 1 Subject matter This Regulation establishes the European Maritime, Fisheries and Aquaculture Fund (the ‘EMFAF’) for the period from 1 January 2021 to 31 December 2027. The duration of the EMFAF is aligned with the duration of the MFF 2021-2027. It lays down the priorities of the EMFAF, its budget and the specific rules for providing Union funding, complementing the general rules applying to the EMFAF under Regulation (EU) 2021/1060. Article 2 Definitions 1. For the purposes of this Regulation and without prejudice to paragraph 2 of this Article, the definitions referred to in Article 4 of Regulation (EU) No 1380/2013, Article 5 of Regulation (EU) No 1379/2013, Article 4 of Regulation (EC) No 1224/2009, Article 2 of Regulation (EU) 2021/523 and Article 2 of Regulation (EU) 2021/1060 apply. 2. For the purposes of this Regulation, the following definitions apply: (1) ‘Common Information Sharing Environment’ or ‘CISE’ means an environment of systems developed to support the exchange of information between authorities involved in maritime surveillance, across sectors and borders, in order to improve their awareness of activities at sea; (2) ‘coast guard’ means national authorities performing coast guard functions, which encompass maritime safety, maritime security, maritime customs, prevention and suppression of trafficking and smuggling, connected maritime law enforcement, maritime border control, maritime surveillance, protection of the marine environment, search and rescue, accident and disaster response, fisheries control, inspection and other activities related to those functions; (3) ‘European marine observation and data network’ or ‘EMODnet’ means a partnership assembling marine data and metadata in order to make those fragmented resources more available and usable by public and private users by offering quality-assured, interoperable and harmonised marine data; (4) ‘exploratory fishing’ means any fishing operation carried out for commercial purposes in a given area, with a view to assessing the profitability and biological sustainability of regular, long-term exploitation of the fishery resources in that area for stocks that have not been subject to commercial fishing; (5) ‘fisher’ means any natural person engaging in commercial fishing activities, as recognised by the Member State concerned; (6) ‘inland fishing’ means fishing activities carried out for commercial purposes in inland waters by vessels or other devices, including those used for ice fishing; (7) ‘international ocean governance’ means a Union initiative to improve the overarching framework encompassing international and regional processes, agreements, arrangements, rules and institutions through a coherent cross-sectoral and rules-based approach, in order to ensure that oceans and seas are healthy, safe, secure, clean and sustainably managed; (8) ‘landing site’ means a location other than a maritime port as defined in point (16) of Article 2 of Regulation (EU) 2017/352 of the European Parliament and of the Council (27), which is officially recognised by a Member State, the use of which is not restricted to its owner and which is primarily used for landings of small-scale coastal fishing vessels; (9) ‘maritime policy’ means the Union policy that aims to foster integrated and coherent decision making to maximise the sustainable development, economic growth and social cohesion of the Union, particularly of the coastal and insular areas and of the outermost regions, and of the sustainable blue economy sectors, through coherent maritime-related policies and relevant international cooperation; (10) ‘maritime security and surveillance’ means activities carried out in order to understand, prevent wherever applicable and manage in a comprehensive way all the events and actions related to the maritime domain which would impact the areas of maritime safety and security, law enforcement, defence, border control, protection of the marine environment, fisheries control, trade and economic interest of the Union; (11) ‘maritime spatial planning’ means a process by which the relevant Member State’s authorities analyse and organise human activities in marine areas to achieve ecological, economic and social objectives; (12) ‘public body’ means the State, regional or local authorities, bodies governed by public law or associations formed by one or more such authorities or by one or more of such bodies, governed by public law; (13) ‘sea basin strategy’ means an integrated framework to address common marine and maritime challenges faced by Member States and, where appropriate, third countries, in a specific sea basin or in one or more sub-sea basins, and promote cooperation and coordination in order to achieve economic, social and territorial cohesion. It is developed by the Commission in cooperation with the Member States and third countries concerned, their regions and other stakeholders as appropriate; (14) ‘small-scale coastal fishing’ means fishing activities carried out by: (a) marine and inland fishing vessels of an overall length of less than 12 metres and not using towed gear as defined in point (1) of Article 2 of Council Regulation (EC) No 1967/2006 (28); or (b) fishers on foot, including shellfish gatherers; (15) ‘sustainable blue economy’ means all sectoral and cross-sectoral economic activities throughout the internal market relating to oceans, seas, coasts and inland waters, covering the Union’s insular and outermost regions and landlocked countries, including emerging sectors and non-market goods and services, aimed at ensuring environmental, social and economic sustainability in the long term and which are consistent with the SDGs, and in particular SDG 14, and with Union environmental legislation. Article 3 Priorities The EMFAF shall contribute to the implementation of the CFP and of the Union’s maritime policy. It shall pursue the following priorities: (1) fostering sustainable fisheries and the restoration and conservation of aquatic biological resources; (2) fostering sustainable aquaculture activities, and processing and marketing of fishery and aquaculture products, thus contributing to food security in the Union; (3) enabling a sustainable blue economy in coastal, island and inland areas, and fostering the development of fishing and aquaculture communities; (4) strengthening international ocean governance and enabling seas and oceans to be safe, secure, clean and sustainably managed. Support under the EMFAF shall contribute to the achievement of the environmental and climate change mitigation and adaptation objectives of the Union. That contribution shall be tracked in accordance with the methodology set out in Annex IV. CHAPTER II Financial framework Article 4 Budget 1. The financial envelope for the implementation of the EMFAF for the period from 1 January 2021 to 31 December 2027 shall be EUR 6 108 000 000 in current prices. 2. The part of the financial envelope allocated to the EMFAF under Title II of this Regulation shall be implemented under shared management in accordance with Regulation (EU) 2021/1060 and Article 63 of the Financial Regulation. 3. The part of the financial envelope allocated to the EMFAF under Title III of this Regulation shall be implemented either directly by the Commission in accordance with point (a) of Article 62(1) of the Financial Regulation or within the framework of indirect management in accordance with point (c) of Article 62(1) of that Regulation. Article 5 Budgetary resources under shared management 1. The part of the financial envelope under shared management as specified in Title II shall be EUR 5 311 000 000 in current prices, in accordance with the annual breakdown set out in Annex V. 2. For operations located in the outermost regions, each Member State concerned shall allocate, within its Union financial support set out in Annex V, at least: (a) EUR 102 000 000 for the Azores and Madeira; (b) EUR 82 000 000 for the Canary Islands; (c) EUR 131 000 000 for Guadeloupe, French Guiana, Martinique, Mayotte, Réunion and Saint-Martin. 3. The compensation referred to in Article 24 shall not exceed 60 % of each of the allocations referred to in points (a), (b) and (c) of paragraph 2 of this Article, or 70 % in circumstances justified in each action plan for the outermost regions. 4. At least 15 % of the Union financial support allocated per Member State shall be allocated in the programme, prepared and submitted in accordance with Article 21(1) and (2) of Regulation (EU) 2021/1060, to the specific objective referred to in point (d) of Article 14(1) of this Regulation. Member States with no access to Union waters may apply a lower percentage with regard to the extent of their control and data collection tasks. 5. The Union financial support from the EMFAF allocated per Member State to the total sum of the support referred to in Articles 17 to 21 shall not exceed the higher of the following thresholds: (a) EUR 6 000 000; or (b) 15 % of the Union financial support allocated per Member State. 6. In accordance with Articles 36 and 37 of Regulation (EU) 2021/1060, the EMFAF may support, at the initiative of a Member State, technical assistance for its effective administration and use. Article 6 Financial distribution for shared management The resources available for commitments by Member States referred to in Article 5(1) for the period from 2021 to 2027 are set out in Annex V. Article 7 Budgetary resources under direct and indirect management 1. The part of the financial envelope under direct and indirect management as specified in Title III shall be EUR 797 000 000 in current prices. 2. The amount referred to in paragraph 1 may be used for technical and administrative assistance for the implementation of the EMFAF, such as preparatory, monitoring, control, audit and evaluation activities, including corporate information technology systems. In particular, the EMFAF may support, at the initiative of the Commission and subject to the ceiling of 1,5 % of the financial envelope referred to in Article 4(1): (a) technical assistance for the implementation of this Regulation as referred to in Article 35 of Regulation (EU) 2021/1060; (b) the preparation, monitoring and evaluation of SFPAs and the Union participation in RFMOs; (c) the setting-up of a European-wide network of local action groups. 3. The EMFAF shall support the costs of information and communication activities linked to the implementation of this Regulation. CHAPTER III Programming Article 8 Programming for support under shared management 1. In accordance with Article 21 of Regulation (EU) 2021/1060, each Member State shall prepare a single programme to implement the priorities set out in Article 3 of this Regulation (the ‘programme’). In the preparation of the programme, the Member States shall endeavour to take into account regional and/or local challenges, as appropriate, and may identify intermediate bodies in accordance with Article 71(3) of Regulation (EU) 2021/1060. 2. Support under Title II of this Regulation in pursuit of the policy objectives set out in Article 5 of Regulation (EU) 2021/1060 shall be organised along the priorities and specific objectives as set out in Annex II to this Regulation. 3. In addition to the elements referred to in Article 22 of Regulation (EU) 2021/1060, the programme shall include: (a) an analysis of the situation in terms of strengths, weaknesses, opportunities and threats and the identification of the needs that require to be addressed in the relevant geographical area, including, where appropriate, sea basins relevant for the programme; (b) where applicable, the action plans for the outermost regions referred to in Article 35. 4. While carrying out the analysis of the situation in terms of the strengths, weaknesses, opportunities and threats referred to in point (a) of paragraph 3 of this Article, Member States shall take into account the specific needs of small-scale coastal fishing, as set out in Annex V to Regulation (EU) 2021/1060. For the specific objectives that contribute to the development of sustainable small-scale coastal fishing, Member States shall describe the types of actions considered for that purpose, as set out in point (i) of point (d) of Article 22(3) of, and Annex V to, Regulation (EU) 2021/1060. The managing authority shall endeavour to take into account the specificities of small-scale coastal fishing operators for possible simplification measures, such as simplified application forms. 5. The Commission shall assess the programme in accordance with Article 23 of Regulation (EU) 2021/1060. In its assessment it shall take into account, in particular: (a) the maximisation of the contribution of the programme to the priorities set out in Article 3 and to the objectives of resilience, green transition and digital transition, including through a wide range of innovative solutions; (b) the contribution of the programme to the development of sustainable small-scale coastal fishing; (c) the contribution of the programme to environmental, economic and social sustainability; (d) the balance between the fishing capacity of the fleets and the available fishing opportunities, as reported annually by Member States in accordance with Article 22(2) of Regulation (EU) No 1380/2013; (e) where applicable, the multiannual management plans adopted under Articles 9 and 10 of Regulation (EU) No 1380/2013, the management plans adopted under Article 19 of Regulation (EC) No 1967/2006 and the recommendations adopted by RFMOs that bind the Union; (f) the implementation of the landing obligation referred to in Article 15 of Regulation (EU) No 1380/2013; (g) the most recent evidence on the socio-economic performance of the sustainable blue economy, in particular in the fishery and aquaculture sector; (h) where applicable, the regional sea basin analyses developed by the Commission indicating the common strengths and weaknesses of each sea basin with regard to the achievement of the objectives of the CFP as set out in Article 2 of Regulation (EU) No 1380/2013; (i) the contribution of the programme to the conservation and restoration of marine ecosystems, while the support related to Natura 2000 areas shall be in accordance with the prioritised action frameworks established pursuant to Article 8(4) of Directive 92/43/EEC; (j) the contribution of the programme to the reduction of marine litter, in accordance with Directive (EU) 2019/904 of the European Parliament and of the Council (29); (k) the contribution of the programme to climate change mitigation and adaptation. Article 9 Programming for support under direct and indirect management In order to implement Title III, the Commission shall adopt implementing acts laying down work programmes. Work programmes shall set out, where applicable, the overall amount reserved for the blending operations referred to in Article 56. Except as regards technical assistance, those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2). TITLE II SUPPORT UNDER SHARED MANAGEMENT CHAPTER I General principles of support Article 10 State aid 1. Without prejudice to paragraph 2 of this Article, Articles 107, 108 and 109 TFEU shall apply to aid granted by Member States to undertakings in the fishery and aquaculture sector. 2. However, Articles 107, 108 and 109 TFEU shall not apply to payments made by Member States pursuant to this Regulation and falling within the scope of Article 42 TFEU. 3. National provisions setting up public financing going beyond the provisions of this Regulation concerning payments referred to in paragraph 2 shall be treated as a whole on the basis of paragraph 1. 4. For the fishery and aquaculture products listed in Annex I TFEU to which Articles 107, 108 and 109 thereof apply, the Commission may authorise, in accordance with Article 108 TFEU, operating aid in the outermost regions referred to in Article 349 TFEU in respect of the sectors producing, processing and marketing fishery and aquaculture products, with a view to alleviating the specific constraints in those regions as a result of their isolation, insularity or remoteness. Article 11 Admissibility of applications 1. An application for support submitted by an operator shall be inadmissible for an identified period of time laid down pursuant to paragraph 4 of this Article, if it has been determined by the competent authority that the operator concerned: (a) has committed serious infringements under Article 42 of Council Regulation (EC) No 1005/2008 (30) or Article 90 of Regulation (EC) No 1224/2009 or under other legislation adopted by the European Parliament and the Council within the framework of the CFP; (b) has been involved in the operation, management or ownership of a fishing vessel included in the Union IUU vessel list as set out in Article 40(3) of Regulation (EC) No 1005/2008, or of a vessel flying the flag of countries identified as non-cooperating third countries as set out in Article 33 of that Regulation; or (c) has committed any of the environmental offences set out in Articles 3 and 4 of Directive 2008/99/EC of the European Parliament and of the Council (31), where the application for support is submitted under Article 27 of this Regulation. 2. If any of the situations referred to in paragraph 1 of this Article occurs throughout the period between submitting the application for support and five years after the final payment, the support paid from EMFAF and related to that application shall be recovered from the operator, in accordance with Article 44 of this Regulation and Article 103 of Regulation (EU) 2021/1060. 3. Without prejudice to more far-reaching national rules as agreed on in the Partnership Agreement with the Member State concerned, an application for support submitted by an operator shall be inadmissible for an identified period of time laid down pursuant to paragraph 4 of this Article, if it has been determined through a final decision by the competent authority concerned that the operator has committed fraud, as defined in Article 3 of Directive (EU) 2017/1371, in the context of the EMFF or the EMFAF. 4. The Commission is empowered to adopt delegated acts, in accordance with Article 62, supplementing this Regulation concerning: (a) the identification of the threshold triggering, and the period of time of, the inadmissibility referred to in paragraphs 1 and 3 of this Article, which shall be proportionate to the nature, gravity, duration and repetition of the serious infringements, offences or fraud committed, and shall be of at least one year’s duration; (b) in accordance with Article 44 of this Regulation and Article 103 of Regulation (EU) 2021/1060, the arrangements for recovering the support granted pursuant to paragraph 2 of this Article, which shall be proportionate to the nature, gravity, duration and repetition of the serious infringements or offences committed; (c) the relevant starting or ending dates of the periods of time referred to in paragraphs 1 and 3 and the conditions for a reduced period of inadmissibility. 5. Member States may apply, in accordance with national rules, a longer inadmissibility period than that laid down pursuant to paragraph 4. Member States may apply an inadmissibility period also to applications for support submitted by operators engaged in inland fishing who have committed serious infringements, as defined by national rules. 6. Member States shall require that operators submitting an application for support under the EMFAF provide to the managing authority a signed statement confirming that they do not fall under any of the situations listed in paragraphs 1 and 3 of this Article. Member States shall verify the veracity of that statement before approving the application, based on the information available in the national registers of infringements referred to in Article 93 of Regulation (EC) No 1224/2009, or any other available data. For the purposes of the verification referred to in the first subparagraph of this paragraph, a Member State shall provide, on request from another Member State, the information contained in its national register of infringements referred to in Article 93 of Regulation (EC) No 1224/2009. Article 12 Eligibility for support from the EMFAF under shared management 1. Without prejudice to the rules on eligibility of expenditure laid down in Regulation (EU) 2021/1060, Member States may select for support under this Title the operations which: (a) fall under the scope of the priorities and specific objectives set out in Article 8(2); (b) are not ineligible pursuant to Article 13; and (c) are in accordance with applicable Union law. 2. The EMFAF may support investments on board necessary to comply with requirements imposed by a Member State to give effect to optional provisions under Directive (EU) 2017/159. Article 13 Ineligible operations or expenditure The following operations or expenditure shall not be eligible for support from the EMFAF: (a) operations that increase the fishing capacity of a fishing vessel, unless otherwise provided for in Article 19; (b) the acquisition of equipment that increases the ability of a fishing vessel to find fish; (c) the construction, acquisition or importation of fishing vessels, unless otherwise provided for in Article 17; (d) the transfer or reflagging of fishing vessels to third countries, including through the creation of joint ventures with partners of third countries; (e) the temporary or permanent cessation of fishing activities, unless otherwise provided for in Articles 20 and 21; (f) exploratory fishing; (g) the transfer of ownership of a business; (h) direct restocking, except explicitly provided for as a reintroduction measure or other conservation measures in a Union legal act or in the case of experimental restocking; (i) the construction of new ports or new auction halls, with the exception of new landing sites; (j) market intervention mechanisms aiming to temporarily or permanently withdraw fishery or aquaculture products from the market with a view to reducing supply in order to prevent price decline or to drive prices up, unless otherwise provided for in Article 26(2); (k) investments on board fishing vessels necessary to comply with the requirements under Union law in force at the time of submission of the application for support, including requirements under the Union’s obligations in the context of RFMOs, unless otherwise provided for in Article 22; (l) investments on board fishing vessels that have carried out fishing activities for less than 60 days in the two calendar years preceding the year of submission of the application for support; (m) the replacement or modernisation of a main or ancillary engine of a fishing vessel, unless otherwise provided for in Article 18. CHAPTER II Priority 1: Fostering sustainable fisheries and the restoration and conservation of aquatic biological resources Section 1 Scope of support Article 14 Specific objectives 1. Support under this Chapter shall cover interventions that contribute to the achievement of the objectives of the CFP as set out in Article 2 of Regulation (EU) No 1380/2013, through one or more of the following specific objectives: (a) strengthening economically, socially and environmentally sustainable fishing activities; (b) increasing energy efficiency and reducing CO2 emissions through the replacement or modernisation of engines of fishing vessels; (c) promoting the adjustment of fishing capacity to fishing opportunities in cases of permanent cessation of fishing activities and contributing to a fair standard of living in cases of temporary cessation of fishing activities; (d) fostering efficient fisheries control and enforcement, including fighting against IUU fishing, as well as reliable data for knowledge-based decision making; (e) promoting a level-playing field for fishery and aquaculture products from the outermost regions; and (f) contributing to the protection and restoration of aquatic biodiversity and ecosystems. 2. Support under this Chapter may be granted to inland fishing under the conditions provided for in Article 16. Section 2 Specific conditions Article 15 Transferring or reflagging of fishing vessels Where support under this Chapter is granted in respect of a Union fishing vessel, that vessel shall not be transferred or reflagged outside the Union during at least five years from the final payment for the supported operation. Article 16 Inland fishing 1. The provisions laid down in point (a) of Article 17(6), point (a) of Article 18(2), points (a) and (d) of Article 19(2), Article 20, points (a) to (d) of Article 21(2), as well as the reference to Regulation (EC) No 1224/2009 in point (d) of Article 19(3) of this Regulation, shall not apply to inland fishing vessels. 2. In the case of inland fishing vessels, the references to the date of registration in the Union fleet register in points (d) and (e) of Article 17(6), point (b) of Article 18(2) and point (c) of Article 19(2) shall be replaced by references to the date of entry into service, in accordance with national law. Article 17 First acquisition of a fishing vessel 1. By way of derogation from point (c) of Article 13, the EMFAF may support the first acquisition of a fishing vessel or the acquisition of partial ownership thereof. The support referred to in the first subparagraph shall contribute to the specific objective referred to in point (a) of Article 14(1). 2. Support under this Article may only be granted to a natural person who: (a) is no more than 40 years of age at the date of submission of the application for support; and (b) has worked at least five years as fisher or has acquired adequate qualification. 3. Support under paragraph 1 may also be granted to legal entities wholly owned by one or more natural persons who each fulfil the conditions set out in paragraph 2. 4. Support under this Article may be granted for the joint first acquisition of a fishing vessel by several natural persons who each fulfil the conditions set out in paragraph 2. 5. Support under this Article may also be granted for the acquisition of partial ownership of a fishing vessel by a natural person who fulfils the conditions set out in paragraph 2 and who shall be deemed to have controlling rights on that vessel through ownership of at least of 33 % of the vessel or of the shares in the vessel or by a legal entity which fulfils the conditions set out in paragraph 3 and which shall be deemed to have controlling rights on that vessel through ownership of at least of 33 % of the vessel or of the shares in the vessel. 6. Support under this Article may be granted only in respect of a fishing vessel which: (a) belongs to a fleet segment for which the latest report on fishing capacity, referred to in Article 22(2) of Regulation (EU) No 1380/2013, has shown a balance with the fishing opportunities available to that segment; (b) is equipped for fishing activities; (c) is not longer than 24 metres in overall length; (d) has been registered in the Union fleet register for at least three calendar years preceding the year of submission of the application for support in the case of a small-scale coastal fishing vessel, and for at least five calendar years in the case of another type of vessel; and (e) has been registered in the Union fleet register for a maximum of 30 calendar years preceding the year of submission of the application for support. 7. The first acquisition of a fishing vessel supported under this Article shall not be considered a transfer of ownership of a business within the meaning of point (g) of Article 13. Article 18 Replacement or modernisation of a main or ancillary engine 1. By way of derogation from point (m) of Article 13, the EMFAF may support the replacement or modernisation of a main or ancillary engine of a fishing vessel up to 24 metres in overall length. The support referred to in the first subparagraph shall contribute to the specific objective referred to in point (b) of Article 14(1). 2. Support under this Article may be granted only under the following conditions: (a) the vessel belongs to a fleet segment for which the latest report on fishing capacity, referred to in Article 22(2) of Regulation (EU) No 1380/2013, has shown a balance with the fishing opportunities available to that segment; (b) the vessel has been registered in the Union fleet register for at least five calendar years preceding the year of submission of the application for support; (c) for small-scale coastal fishing vessels, the new or modernised engine does not have more power in kW than that of the current engine; and (d) for other vessels up to 24 metres in overall length, the new or modernised engine does not have more power in kW than that of the current engine and emits at least 20 % less CO2 compared to the current engine. 3. Member States shall ensure that all replaced or modernised engines are subject to a physical verification. 4. The fishing capacity withdrawn due to the replacement or modernisation of a main or ancillary engine shall not be replaced. 5. The reduction of CO2 emission required under point (d) of paragraph 2 shall be considered to be met in either of the following cases: (a) where relevant information certified by the manufacturer of the engine concerned as part of a type approval or product certificate indicates that the new engine emits 20 % less CO2 than the engine being replaced; or (b) where relevant information certified by the manufacturer of the engine concerned as part of a type approval or product certificate indicates that the new engine uses 20 % less fuel than the engine being replaced. Where the relevant information certified by the manufacturer of the engine concerned as part of a type approval or product certificate for one or both of the engines does not permit a comparison of the CO2 emission or fuel consumption, the reduction of CO2 emission required under point (d) of paragraph 2 shall be considered to be met in any of the following cases: (a) the new engine uses an energy-efficient technology and the age difference between the new engine and the engine being replaced is at least seven years; (b) the new engine uses a type of fuel or a propulsion system which is considered to emit less CO2 than the engine being replaced; (c) the Member State measures that the new engine emits 20 % less CO2 or uses 20 % less fuel than the engine being replaced under the normal fishing effort of the vessel concerned. The Commission shall adopt implementing acts to identify the energy-efficient technologies referred to in point (a) of the second subparagraph of this paragraph and to further specify the methodology elements for the implementation of point (c) of that subparagraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2). Article 19 Increase in the gross tonnage of a fishing vessel to improve safety, working conditions or energy efficiency 1. By way of derogation from point (a) of Article 13, the EMFAF may support operations that increase the gross tonnage of a fishing vessel for the purposes of improving safety, working conditions or energy efficiency. The support referred to in the first subparagraph shall contribute to the specific objective referred to in point (a) of Article 14(1). 2. Support under this Article may be granted only under the following conditions: (a) the fishing vessel belongs to a fleet segment for which the latest report on fishing capacity, referred to in Article 22(2) of Regulation (EU) No 1380/2013, has shown a balance of the fishing capacity of the segment with the fishing opportunities available to that segment; (b) the fishing vessel is not longer than 24 metres in overall length; (c) the fishing vessel has been registered in the Union fleet register for at least the 10 calendar years preceding the year of submission of the application for support; and (d) the entry into the fishing fleet of new fishing capacity generated by the operation is compensated for by the prior withdrawal of at least the same amount of fishing capacity without public aid from the same fleet segment or from a fleet segment for which the latest report on fishing capacity, referred to in Article 22(2) of Regulation (EU) No 1380/2013, has shown that the fishing capacity is not in balance with the fishing opportunities available to that segment. 3. For the purposes of paragraph 1, only the following operations shall be eligible: (a) the increase in gross tonnage necessary for the subsequent installation or renovation of accommodation facilities dedicated to the exclusive use of the crew, including sanitary facilities, common areas, kitchen facilities and shelter deck structures; (b) the increase in gross tonnage necessary for the subsequent improvement or installation of on-board fire prevention systems, safety and alarm systems or noise-reduction systems; (c) the increase in gross tonnage necessary for the subsequent installation of integrated bridge systems to improve navigation or engine control; (d) the increase in gross tonnage necessary for the subsequent installation or renovation of an engine or a propulsion system that demonstrates a better energy efficiency or lower CO2 emissions compared to the previous situation, which does not have a power exceeding the fishing vessel’s previously certified engine power pursuant to Article 40(1) of Regulation (EC) No 1224/2009, and whose maximum power output is certified by the manufacturer for that engine or propulsion system model; (e) the replacement or renovation of the bulbous bow provided that it improves the overall energy efficiency of the fishing vessel. 4. As part of the data provided pursuant to Article 46(3), Member States shall communicate to the Commission the characteristics of the operations supported under this Article, including the amount of the fishing capacity increased and the purpose of that increase. 5. Support under this Article shall not cover operations related to investments aimed at improving safety, working conditions or energy efficiency where such operations do not increase the fishing capacity of the vessel concerned. Those operations may be supported in accordance with Article 12. Article 20 Permanent cessation of fishing activities 1. By way of derogation from point (e) of Article 13, the EMFAF may support compensation for the permanent cessation of fishing activities. The support referred to in the first subparagraph of this paragraph shall contribute to the specific objective referred to in point (c) of Article 14(1). 2. Support under this Article may be granted only under the following conditions: (a) the cessation is foreseen as a tool of an action plan referred to in Article 22(4) of Regulation (EU) No 1380/2013; (b) the cessation is achieved through the scrapping of the fishing vessel or through its decommissioning and retrofitting for activities other than commercial fishing, keeping in line with the objectives of the CFP and of the multiannual plans referred to in Regulation (EU) No 1380/2013; (c) the fishing vessel is registered as active and has carried out fishing activities at sea for at least 90 days per year during the last two calendar years preceding the date of submission of the application for support; (d) the equivalent fishing capacity is permanently removed from the Union fishing fleet register and the fishing licences and the fishing authorisations are permanently withdrawn, in accordance with Article 22(5) and (6) of Regulation (EU) No 1380/2013; and (e) the beneficiary shall not register any fishing vessel within five years following the receipt of support. 3. The support referred to in paragraph 1 may only be granted to: (a) owners of Union fishing vessels concerned by the permanent cessation; and (b) fishers who have worked at sea on board a Union fishing vessel concerned by the permanent cessation for at least 90 days per year during the last two calendar years preceding the year of submission of the application for support. The fishers referred to in point (b) of the first subparagraph shall cease all fishing activities for five years following the receipt of support. If a fisher returns to fishing activities within that period of time, sums unduly paid in respect of the operation shall be recovered by the Member State concerned, in an amount proportionate to the period during which the condition set out in the first sentence of this subparagraph has not been fulfilled. Article 21 Temporary cessation of fishing activities 1. By way of derogation from point (e) of Article 13, the EMFAF may support compensation for the temporary cessation of fishing activities. The support referred to in the first subparagraph shall contribute to the specific objective referred to in point (c) of Article 14(1). 2. Support under this Article may be granted only in the case of: (a) conservation measures, as referred to in points (a), (b), (c), (i) and (j) of Article 7(1) of Regulation (EU) No 1380/2013 or, where applicable to the Union, equivalent conservation measures adopted by RFMOs; (b) Commission measures in case of a serious threat to marine biological resources, as referred to in Article 12 of Regulation (EU) No 1380/2013; (c) Member States’ emergency measures pursuant to Article 13 of Regulation (EU) No 1380/2013; (d) the interruption, due to reasons of force majeure, of the application of a SFPA or protocol thereto; or (e) natural disasters, environmental incidents or health crises, as formally recognised by the competent authorities of the relevant Member State. 3. The support referred to in paragraph 1 may only be granted where the fishing activities of the vessel or fisher concerned are stopped during at least 30 days in a given calendar year. 4. The support referred to in point (a) of paragraph 2 may only be granted where, based on scientific advice, a reduction of fishing effort is needed in order to achieve the objectives referred to in Article 2(2) and point (a) of Article 2(5) of Regulation (EU) No 1380/2013. 5. The support referred to in paragraph 1 may only be granted to: (a) owners or operators of Union fishing vessels which are registered as active and which have carried out fishing activities at sea for at least 120 days during the last two calendar years preceding the year of submission of the application for support; (b) fishers who have worked at sea on board a Union fishing vessel concerned by the temporary cessation for at least 120 days during the last two calendar years preceding the year of submission of the application for support; or (c) fishers on foot who have carried out fishing activities for at least 120 days during the last two calendar years preceding the year of submission of the application for support. The reference to the number of days at sea in this paragraph shall not apply to eel fisheries. 6. The support referred to in paragraph 1 may be granted for a maximum duration of 12 months per vessel or per fisher during the programming period. 7. All fishing activities carried out by the vessels or fishers concerned shall be effectively suspended during the period concerned by the temporary cessation. The Member State concerned shall satisfy itself that the vessel or fisher concerned has ceased any fishing activities during the period concerned by the temporary cessation and that any overcompensation resulting from the use of the vessel for other purposes is avoided. Article 22 Control and enforcement 1. The EMFAF may support the development and implementation of a Union fisheries control system as provided for in Article 36 of Regulation (EU) No 1380/2013 and further specified in Regulations (EC) No 1224/2009 and (EC) No 1005/2008. The support referred to in the first subparagraph shall contribute to the specific objective referred to in point (d) of Article 14(1). 2. By way of derogation from point (k) of Article 13, the support referred to in paragraph 1 of this Article may cover: (a) the purchase, installation and management on board of the necessary components for compulsory vessel tracking and electronic reporting systems used for control purposes; (b) the purchase, installation and management on board of the necessary components for compulsory remote electronic monitoring systems used for controlling the implementation of the landing obligation referred to in Article 15 of Regulation (EU) No 1380/2013; (c) the purchase, installation and management on board of devices for compulsory continuous measurement and recording of propulsive engine power. 3. The support referred to in paragraph 1 of this Article may also contribute to maritime surveillance as referred to in Article 33 and to the cooperation on coast guard functions as referred to in Article 34. Article 23 Collection, management, use and processing of data in the fisheries sector, and research and innovation programmes 1. The EMFAF may support the collection, management, use and processing of biological, environmental, technical and socio-economic data in the fisheries sector, as provided for in Article 25(1) and (2) of Regulation (EU) No 1380/2013 and further specified in Regulation (EU) 2017/1004, on the basis of the national work plans referred to in Article 6 of Regulation (EU) 2017/1004. The EMFAF may also support fisheries and aquaculture research and innovation programmes, as provided for in Article 27 of Regulation (EU) No 1380/2013. 2. The support referred to in paragraph 1 of this Article shall contribute to the specific objective referred to in point (d) of Article 14(1). Article 24 Promoting a level-playing field for fishery and aquaculture products from the outermost regions 1. The EMFAF may support compensation for additional costs incurred by operators in the fishing, farming, processing and marketing of certain fishery and aquaculture products from the outermost regions. 2. The support referred to in paragraph 1 of this Article shall contribute to the specific objective referred to in point (e) of Article 14(1). 3. Support under this Article may be granted only under the conditions set out in Article 36. Article 25 Protection and restoration of aquatic biodiversity and ecosystems 1. The EMFAF may support actions that contribute to the protection and restoration of aquatic biodiversity and ecosystems, including in inland waters. The support referred to in the first subparagraph shall contribute to the specific objective referred to in point (f) of Article 14(1). 2. The support referred to in paragraph 1 may include, inter alia: (a) compensation to fishers for the passive collection of lost fishing gear and marine litter from the sea; (b) investments in ports or other infrastructure to provide adequate reception facilities for lost fishing gear and marine litter collected from the sea; (c) actions to achieve or maintain a good environmental status in the marine environment, as set out in Article 1(1) of Directive 2008/56/EC; (d) the implementation of spatial protection measures established pursuant to Article 13(4) of Directive 2008/56/EC; (e) the management, restoration, surveillance and monitoring of Natura 2000 areas, taking into account the prioritised action frameworks established pursuant to Article 8 of Directive 92/43/EEC; (f) the protection of species under Directives 92/43/EEC and 2009/147/EC, taking into account the prioritised action frameworks established pursuant to Article 8 of Directive 92/43/EEC; (g) the restoration of inland waters in accordance with the programme of measures established pursuant to Article 11 of Directive 2000/60/EC. CHAPTER III Priority 2: Fostering sustainable aquaculture activities and processing and marketing of fishery and aquaculture products, thus contributing to food security in the Union Section 1 Scope of support Article 26 Specific objectives 1. Support under this Chapter shall cover interventions that contribute to the achievement of the objectives of the CFP as set out in Article 2 of Regulation (EU) No 1380/2013, through the following specific objectives: (a) promoting sustainable aquaculture activities, especially strengthening the competitiveness of aquaculture production, while ensuring that the activities are environmentally sustainable in the long term; (b) promoting marketing, quality and added value of fishery and aquaculture products, as well as processing of those products. 2. By way of derogation from point (j) of Article 13, in case of exceptional events causing a significant disruption of markets, the support referred to in point (b) of paragraph 1 of this Article may cover: (a) compensation to operators of the fishery and aquaculture sector for their income foregone or additional costs; and (b) compensation to recognised producer organisations and associations of producer organisations which store fishery products listed in Annex II to Regulation (EU) No 1379/2013, provided that those products are stored in accordance with Articles 30 and 31 of that Regulation. The support referred to in the first subparagraph may be eligible only if the Commission has established, by means of an implementing decision, the occurrence of an exceptional event. Expenditure shall be eligible only during the duration set out in that implementing decision. 3. In addition to the activities referred to in point (a) of paragraph 1 of this Article within the scope of Article 2 of Regulation (EU) No 1380/2013, support under that point may also cover interventions that contribute to aquaculture providing environmental services, as well as to ensuring animal health and welfare in aquaculture within the scope of Regulation (EU) 2016/429 of the European Parliament and of the Council (32). 4. Support under point (b) of paragraph 1 of this Article may also contribute to the achievement of the objectives of common organisation of the markets in fishery and aquaculture products as provided for in Article 35 of Regulation (EU) No 1380/2013, including the production and marketing plans as described in Article 28 of Regulation (EU) No 1379/2013. Section 2 Specific conditions Article 27 Aquaculture To achieve the specific objective referred to in point (a) of Article 26(1) of this Regulation as regards the promotion of aquaculture activities, support shall be consistent with the multiannual national strategic plans for the development of aquaculture referred to in Article 34(2) of Regulation (EU) No 1380/2013. Article 28 Processing of fishery and aquaculture products To achieve the specific objective referred to in point (b) of Article 26(1) of this Regulation as regards the processing of fishery and aquaculture products, support to enterprises other than SMEs shall only be granted through the financial instruments provided for in Article 58 of Regulation (EU) 2021/1060 or through InvestEU, in accordance with Article 10 of Regulation (EU) 2021/523. CHAPTER IV Priority 3: Enabling a sustainable blue economy in coastal, island and inland areas, and fostering the development of fishing and aquaculture communities Section 1 Scope of support Article 29 Specific objective Support under this Chapter shall cover interventions that contribute to enabling a sustainable blue economy in coastal, island and inland areas, and to fostering the sustainable development of fishing and aquaculture communities. Section 2 Specific conditions Article 30 Community-led local development 1. To achieve the specific objective referred to in Article 29 of this Regulation, support shall be implemented through the CLLD set out in Article 31 of Regulation (EU) 2021/1060. 2. For the purposes of this Article, the CLLD strategies referred to in Article 32 of Regulation (EU) 2021/1060 shall ensure that communities in fishing or aquaculture areas better exploit and benefit from the opportunities offered by the sustainable blue economy, capitalising on and strengthening environmental, cultural, social and human resources. Those CLLD strategies may range from those which focus on fisheries or aquaculture to broader strategies directed at the diversification of local communities. CHAPTER V Priority 4: Strengthening international ocean governance and enabling seas and oceans to be safe, secure, clean and sustainably managed Section 1 Scope of support Article 31 Specific objective Support under this Chapter shall cover interventions that contribute to strengthening sustainable sea and ocean management through the promotion of marine knowledge, maritime surveillance or coast guard cooperation. Section 2 Specific conditions Article 32 Marine knowledge Support granted to achieve the specific objective referred to in Article 31 of this Regulation through the promotion of marine knowledge shall contribute to actions aiming to collect, manage, analyse, process and use data to improve the knowledge on the state of the marine environment, with a view to: (a) fulfilling monitoring and site designation and management requirements under Directives 92/43/EEC and 2009/147/EC; (b) supporting maritime spatial planning under Directive 2014/89/EU of the European Parliament and of the Council (33); or (c) increasing data quality and sharing through the European marine observation and data network (EMODnet). Article 33 Maritime surveillance 1. To achieve the specific objective set out in Article 31 through the promotion of maritime surveillance, support shall be granted for actions contributing to the achievement of the objectives of the CISE. 2. The support for actions referred to in paragraph 1 of this Article may also contribute to the development and implementation of a Union fisheries control system under the conditions set out in Article 22. Article 34 Coast guard cooperation 1. Support granted to achieve the specific objective set out in Article 31 through the promotion of coast guard cooperation shall contribute to actions carried out by national authorities in the framework of the European cooperation on coast guard functions referred to in Article 69 of Regulation (EU) 2019/1896 of the European Parliament and of the Council (34), Article 2b of Regulation (EC) No 1406/2002 of the European Parliament and of the Council (35) and Article 8 of Regulation (EU) 2019/473 of the European Parliament and of the Council (36). 2. The support for actions referred to in paragraph 1 of this Article may also contribute to the development and implementation of a Union fisheries control system under the conditions set out in Article 22. CHAPTER VI Sustainable development of the outermost regions Article 35 Action plan for the outermost regions In accordance with Article 8(3), Member States concerned shall prepare, as part of their programme, an action plan for each of their outermost regions, which shall set out: (a) a strategy for the sustainable exploitation of fisheries and the development of sustainable blue economy sectors; (b) a description of the main actions envisaged and the corresponding financial means, including: (i) the structural support to the fishery and aquaculture sector under this Title; (ii) compensation for additional costs referred to in Articles 24 and 36, including the methodology for its calculation; (iii) any other investment in the sustainable blue economy necessary to achieve a sustainable coastal development. Article 36 Compensation for additional costs for fishery and aquaculture products 1. To implement the compensation for additional costs incurred by operators in the fishing, farming, processing and marketing of certain fishery and aquaculture products from the outermost regions, as referred to in Article 24, each Member State concerned shall determine, in line with the criteria laid down in accordance with paragraph 6 of this Article, for each outermost region, the list of fishery and aquaculture products and the quantity of those products eligible for compensation. 2. When establishing the lists and the quantities referred to in paragraph 1, Member States shall take into account all relevant factors, in particular the need to ensure that the compensation is compatible with the rules of the CFP. 3. The compensation shall not be granted for fishery and aquaculture products: (a) caught by third country vessels, with the exception of fishing vessels which fly the flag of Venezuela and operate in Union waters, in accordance with Council Decision (EU) 2015/1565 (37); (b) caught by Union fishing vessels that are not registered in a port of one of the outermost regions; (c) imported from third countries. 4. Point (b) of paragraph 3 shall not apply if the existing capacity of the processing industry in the outermost region concerned exceeds the quantity of raw material supplied. 5. The compensation paid to the beneficiaries carrying out the activities referred to in paragraph 1 in the outermost regions or owning a vessel registered in a port of one of those regions and operating there shall, in order to avoid overcompensation, take into account: (a) for each fishery or aquaculture product or category of products, the additional costs resulting from the specific handicaps of the regions concerned; and (b) any other type of public intervention affecting the level of additional costs. 6. The Commission is empowered to adopt delegated acts, in accordance with Article 62, supplementing this Regulation by laying down the criteria for the calculation of the additional costs resulting from the specific handicaps of the regions concerned. Article 37 State aid for implementation of compensation for additional costs Member States may grant additional financing for the implementation of the compensation referred to in Article 24. In such cases, Member States shall notify the Commission of the State aid, which the Commission may approve in accordance with this Regulation as part of that compensation. State aid thus notified shall be regarded as notified within the meaning of the first sentence of Article 108(3) TFEU. Article 38 Evaluation When carrying out the mid-term evaluation referred to in Article 45 of Regulation (EU) 2021/1060, the Commission shall specifically examine the provisions of this Chapter, including those related to compensation of additional costs. CHAPTER VII Rules for implementation under shared management Section 1 Support from the EMFAF Article 39 Calculation of compensation Compensation for additional costs or income foregone and other compensation provided under this Regulation shall be granted under any of the forms referred to in points (b) to (e) of Article 53(1) of Regulation (EU) 2021/1060. Article 40 Determination of co-financing rates The maximum EMFAF co-financing rate per specific objective shall be 70 % of the eligible public expenditure, with the exception of the specific objective referred to in point (e) of Article 14(1), for which it shall be 100 %. Article 41 Intensity of public aid 1. Member States shall apply a maximum aid intensity rate of 50 % of the total eligible expenditure of the operation. 2. By way of derogation from paragraph 1, specific maximum aid intensity rates are set out in Annex III. 3. Where one operation falls under several of the rows 2 to 19 of Annex III, the highest maximum aid intensity rate shall apply. 4. Where one operation falls under one or several of the rows 2 to 19 of Annex III and at the same time under row 1 of that Annex, the maximum aid intensity rate referred to in row 1 shall apply. Section 2 Financial management Article 42 Interruption of the payment deadline 1. In accordance with Article 96(4) of Regulation (EU) 2021/1060, the Commission may interrupt the payment deadline for all or part of a payment application in the case of non-compliance by a Member State with the rules applicable under the CFP, if the non-compliance is liable to affect the expenditure contained in a payment application for which the interim payment is requested. 2. Prior to the interruption referred to in paragraph 1, the Commission shall inform the Member State concerned about the non-compliance and give it the opportunity to present observations within a reasonable period of time. 3. The interruption referred to in paragraph 1 shall be proportionate to the nature, gravity, duration and repetition of the non-compliance. 4. The Commission may adopt implementing acts to define the cases of non-compliance referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2). Article 43 Suspension of payments 1. In accordance with Article 97(3) of Regulation (EU) 2021/1060, the Commission may adopt implementing acts suspending all or part of the interim payments under the programme in the case of serious non-compliance by a Member State with the rules applicable under the CFP, if the serious non-compliance is liable to affect the expenditure contained in a payment application for which the interim payment is requested. 2. Prior to the suspension referred to in paragraph 1, the Commission shall inform the Member State concerned that the Commission considers that there is a case of serious non-compliance by that Member State with the rules applicable under the CFP and give it opportunity to present observations within a reasonable period of time. 3. The suspension referred to in paragraph 1 shall be proportionate to the nature, gravity, duration and repetition of the serious non-compliance. 4. The Commission may adopt implementing acts to define the cases of serious non-compliance referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2). Article 44 Financial corrections by Member States In the cases of the financial corrections referred to in Article 11(2),, Member States shall determine the amount of the correction, which shall be proportionate to the nature, gravity, duration and repetition of the serious infringements or offences by the beneficiary concerned and the importance of the EMFAF contribution to the economic activity of that beneficiary. Article 45 Financial corrections by the Commission 1. In accordance with Article 104(5) of Regulation (EU) 2021/1060, the Commission may adopt implementing acts making financial corrections by cancelling all or part of the Union contribution to the programme if, after carrying out the necessary examination, it concludes that: (a) expenditure contained in a payment application is affected by cases where any of the situations referred to in Article 11(2) of this Regulation has occurred and has not been corrected by the Member State concerned prior to the opening of the correction procedure under this paragraph; (b) expenditure contained in a payment application is affected by cases of serious non-compliance with the rules of the CFP by the Member State which have resulted in the suspension of payment under Article 43 of this Regulation and the Member State concerned still fails to demonstrate that it has taken the necessary remedial action to ensure compliance with, and the enforcement of, applicable rules of the CFP in the future. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2) of this Regulation. 2. The Commission shall decide on the amount of the correction taking into account the nature, gravity, duration and repetition of the serious non-compliance with the rules of the CFP by the Member State or beneficiary concerned and the importance of the EMFAF contribution to the economic activity of the beneficiary concerned. 3. Where it is not possible to quantify precisely the amount of expenditure linked to serious non-compliance with the rules of the CFP by the Member State, the Commission shall apply a flat rate or extrapolated financial correction in accordance with paragraph 4. 4. The Commission may adopt implementing acts to determine the criteria for establishing the level of financial correction to be applied and the criteria for applying flat rates or extrapolated financial corrections. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2). Section 3 Monitoring and reporting Article 46 Monitoring and evaluation framework 1. Common output and result indicators for the EMFAF, as set out in Annex I to this Regulation, and, where necessary, programme-specific indicators, shall be used in accordance with point (a) of the second subparagraph of Article 16(1), point (d)(ii) of Article 22(3) and point (b) of Article 42(2) of Regulation (EU) 2021/1060. 2. In compliance with its reporting requirement pursuant to paragraph (iii) of point (h) of Article 41(3) of the Financial Regulation, the Commission shall report to the European Parliament and the Council on the performance of the EMFAF. In that report, the Commission shall use the core performance indicators set out in Annex I to this Regulation. 3. In addition to the general rules set out in Article 42 of Regulation (EU) 2021/1060, the managing authority shall provide the Commission with relevant operation-level implementation data, which shall include key characteristics of the beneficiary (name, type of beneficiary, size of enterprise, gender and contact details) and of the operation supported (specific objective, type of operation, sector concerned, values of indicators, state of progress of the operation, common fleet register number, financial data and form of support). The data shall be provided by 31 January and 31 July of each year. The first transmission of those data shall be due by 31 January 2022 and the last one by 31 January 2030. 4. The Commission shall adopt implementing acts laying down rules further specifying the exact data referred to in paragraph 3 of this Article and its presentation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 63(2). 5. The Commission is empowered to adopt delegated acts, in accordance with Article 62, to amend Annex I by adding the core performance indicators in order to adapt to changes occurring during the programming period. Article 47 Reporting of the results of the funded operation 1. The beneficiaries shall report the value of relevant result indicators after the completion of the operation and no later than the final payment application. The managing authority shall review the plausibility of the value of result indicators reported by the beneficiary in parallel with the final payment. 2. Member States may postpone the timelines established in paragraph 1. TITLE III SUPPORT UNDER DIRECT AND INDIRECT MANAGEMENT CHAPTER I Priority 1: Fostering sustainable fisheries and the restoration and conservation of aquatic biological resources Article 48 Implementation of the CFP The EMFAF shall support the implementation of the CFP through: (a) the provision of scientific advice and knowledge for the purposes of promoting sound and efficient fisheries management decisions under the CFP, including through the participation of experts in scientific bodies; (b) regional cooperation on conservation measures as referred to in Article 18 of Regulation (EU) No 1380/2013, in particular in the context of the multiannual plans referred to in Articles 9 and 10 thereof; (c) the development and implementation of a Union fisheries control system as provided for in Article 36 of Regulation (EU) No 1380/2013 and further specified in Regulation (EC) No 1224/2009; (d) the functioning of Advisory Councils established in accordance with Article 43 of Regulation (EU) No 1380/2013, an objective of which is forming part of, and supporting, the CFP; (e) voluntary contributions to the activities of international organisations dealing with fisheries, in accordance with Articles 29 and 30 of Regulation (EU) No 1380/2013. Article 49 Promotion of clean and healthy seas and oceans 1. The EMFAF shall support the promotion of clean and healthy seas and oceans, including through actions to support the implementation of Directive 2008/56/EC and actions to ensure coherence with the objective of achieving a good environmental status as set out in point (j) of Article 2(5) of Regulation (EU) No 1380/2013, and the implementation of the European strategy for plastics in a circular economy. 2. The support referred to in paragraph 1 of this Article shall be in line with the Union environmental legislation, in particular with the objective of achieving or maintaining a good environmental status as set out in Article 1(1) of Directive 2008/56/EC. CHAPTER II Priority 2: Fostering sustainable aquaculture activities and processing and marketing of fishery and aquaculture products, thus contributing to food security in the Union. Article 50 Market intelligence The EMFAF shall support the development and dissemination of market intelligence for fishery and aquaculture products by the Commission in accordance with Article 42 of Regulation (EU) No 1379/2013. CHAPTER III Priority 3: Enabling a sustainable blue economy in coastal, island and inland areas, and fostering the development of fishing and aquaculture communities Article 51 Maritime policy and development of a sustainable blue economy The EMFAF shall support the implementation of the maritime policy and the development of a sustainable blue economy through: (a) the promotion of a sustainable, low carbon and climate resilient blue economy; (b) the promotion of an integrated governance and management of the maritime policy, including through maritime spatial planning, sea basin strategies and maritime regional cooperation; (c) the enhancement of the transfer and uptake of research, innovation and technology in the sustainable blue economy; (d) the improvement of maritime skills, ocean literacy and sharing of socio-economic and environmental data on the sustainable blue economy; (e) the development of project pipelines and innovative financing instruments. CHAPTER IV Priority 4: Strengthening international ocean governance and enabling seas and oceans to be safe, secure, clean and sustainably managed Article 52 European marine observation and data network The EMFAF shall support the implementation of the EMODnet. Article 53 Maritime security and surveillance The EMFAF shall support the promotion of maritime security and surveillance, including through data sharing, cooperation among coast guards and among agencies, and the fight against criminal and illegal activities at sea. Article 54 International ocean governance The EMFAF shall support the implementation of the international ocean governance policy through: (a) voluntary contributions to international organisations active in the field of ocean governance; (b) voluntary cooperation with, and coordination among, international fora, organisations, bodies and institutions in the context of the United Nations Convention on the Law of the Sea, the ‘2030 Agenda’ and other relevant international agreements, arrangements and partnerships; (c) the implementation of ocean partnerships between the Union and relevant ocean actors; (d) the implementation of relevant international agreements, arrangements and instruments that aim to promote better ocean governance, as well as the development of actions, measures, tools and knowledge that enable safe, secure, clean and sustainably managed seas and oceans; (e) the implementation of relevant international agreements, measures and tools to prevent, deter and eliminate IUU fishing; (f) international cooperation on, and development of, ocean research and data. CHAPTER V Rules for implementation under direct and indirect management Article 55 Forms of Union funding 1. The EMFAF may provide funding in any of the forms laid down in the Financial Regulation, in particular procurement and grants pursuant to Titles VII and VIII of that Regulation, respectively. It may also provide financing in the form of financial instruments within blending operations, as referred to in Article 56 of this Regulation. 2. The evaluation of grant proposals may be carried out by independent experts. Article 56 Blending operations Blending operations under the EMFAF shall be implemented in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation. Article 57 Evaluation by the Commission 1. Evaluations shall be carried out in a timely manner to feed into the decision-making process. Evaluations shall be entrusted to internal or external experts who are functionally independent. 2. The interim evaluation of the support under Title III shall be performed by the end of 2024. 3. A final evaluation report on the support under Title III shall be prepared by the end of 2031. 4. The Commission shall communicate the evaluation reports referred to in paragraphs 2 and 3 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Article 58 Monitoring under direct and indirect management 1. The Commission shall use the result and output indicators set out in Annex I to monitor the results of the implementation of the EMFAF under direct and indirect management. 2. The Commission shall collect data on operations selected for support under direct and indirect management, including key characteristics of the beneficiary and the operation, as set out in Article 46(3). Article 59 Audits Audits on the use of the Union contribution carried out by persons or entities, including by persons or entities other than those mandated by the Union institutions or bodies, shall form the basis of the overall assurance pursuant to Article 127 of the Financial Regulation. Article 60 Information, communication and publicity 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the EMFAF, to actions taken pursuant to the EMFAF and to the results obtained. Financial resources allocated to the EMFAF shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the priorities referred to in Article 3. Article 61 Eligible entities, activities and costs 1. The eligibility criteria set out in paragraphs 2 and 3 of this Article shall apply in addition to the criteria set out in Article 197 of the Financial Regulation. 2. The following entities shall be eligible: (a) legal entities established in a Member State or in a third country listed in the work programme under the conditions specified in paragraphs 3 and 4; (b) any legal entity created under Union law or any international organisation. 3. Legal entities established in a third country shall be exceptionally eligible to participate where this is necessary for the achievement of the objectives of a given action. 4. Legal entities established in a third country which is not associated to the programme shall in principle bear the cost of their participation. 5. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation and by way of derogation from Article 193(4) thereof, taking into account the delayed entry into force of this Regulation and in order to ensure continuity, as established in the financing decision and for a limited period, activities supported under this Regulation and the underlying costs may be considered eligible as of 1 January 2021, even if the activities were implemented and the costs incurred before the grant application was submitted. TITLE IV PROCEDURAL PROVISIONS Article 62 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 11, 36, 46 and 65 shall be conferred on the Commission from 14 July 2021 until 31 December 2027. 3. The delegation of power referred to in Articles 11, 36, 46 and 65 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the powers specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 11, 36, 46 and 65 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council. Article 63 Committee procedure 1. The Commission shall be assisted by a Committee for the European Maritime, Fisheries and Aquaculture Fund. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. TITLE V FINAL PROVISIONS Article 64 Amendments to Regulation (EU) 2017/1004 Article 6 of Regulation (EU) 2017/1004 is amended as follows: (1) paragraphs 1 and 2 are replaced by the following: ‘1. Without prejudice to their current data collection obligations under Union law, Member States shall collect data within the framework of a work plan drawn up in accordance with the multiannual Union programme (the ‘national work plan’). Member States shall submit to the Commission by electronic means their national work plans by 15 October of the year preceding the year from which the national work plan is to apply, unless an existing plan still applies, in which case they shall notify the Commission thereof. 2. The Commission shall adopt implementing acts approving the national work plans referred to in paragraph 1 by 31 December of the year preceding the year from which the national work plan is to apply. When approving the national work plans, the Commission shall take into account the evaluation conducted by STECF in accordance with Article 10. If such evaluation indicates that the national work plan does not comply with this Article or does not ensure the scientific relevance of the data or sufficient quality of the proposed methods and procedures, the Commission shall immediately inform the Member State concerned and indicate amendments to that work plan that the Commission considers necessary. Subsequently, the Member State concerned shall submit a revised national work plan to the Commission.’; (2) the following paragraph is added: ‘5. The Commission may adopt implementing acts laying down rules on procedures, format and timetables for the submission of the national work plans referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25(2).’. Article 65 Transitional provisions 1. Regulation (EU) No 508/2014 and any delegated and implementing act adopted pursuant to that Regulation shall continue to apply to programmes and operations supported from the EMFF under the 2014-2020 programming period. 2. In order to facilitate the transition from the support scheme established by Regulation (EU) No 508/2014 to the scheme established by this Regulation, the Commission is empowered to adopt delegated acts, in accordance with Article 62 of this Regulation, to lay down the conditions under which support approved by the Commission under Regulation (EU) No 508/2014 may be integrated into support provided under this Regulation. 3. References to Regulation (EU) No 508/2014 shall be construed as references to this Regulation with regard to the programming period for 2021-2027. Article 66 Entry into force and date of application This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021 with regard to the support under direct and indirect management provided for in Title III. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 7 July 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. LOGAR (1) OJ C 110, 22.3.2019, p. 104. (2) OJ C 361, 5.10.2018, p. 9. (3) Position of the European Parliament of 4 April 2019 (OJ C 116, 31.3.2021, p. 81) and position of the Council at first reading of 14 June 2021 (OJ C 271, 7.7.2021, p. 1). Position of the European Parliament of 5 July 2021 (not yet published in the Official Journal). (4) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11). (5) Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159). (6) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30). (7) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (8) Regulation (EU) No 508/2014 of the European Parliament and of the Council of 15 May 2014 on the European Maritime and Fisheries Fund and repealing Council Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006 and (EC) No 791/2007 and Regulation (EU) No 1255/2011 of the European Parliament and of the Council (OJ L 149, 20.5.2014, p. 1). (9) Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19). (10) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). (11) Council Directive (EU) 2017/159 of 19 December 2016 implementing the Agreement concerning the implementation of the Work in Fishing Convention, 2007 of the International Labour Organisation, concluded on 21 May 2012 between the General Confederation of Agricultural Cooperatives in the European Union (Cogeca), the European Transport Workers’ Federation (ETF) and the Association of National Organisations of Fishing Enterprises in the European Union (Europêche) (OJ L 25, 31.1.2017, p. 12). (12) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (13) Regulation (EU) 2017/1004 of the European Parliament and of the Council of 17 May 2017 on the establishment of a Union framework for the collection, management and use of data in the fisheries sector and support for scientific advice regarding the common fisheries policy and repealing Council Regulation (EC) No 199/2008 (OJ L 157, 20.6.2017, p. 1). (14) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). (15) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). (16) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). (17) Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (OJ L 354, 28.12.2013, p. 1). (18) Council Decision 98/392/EC of 23 March 1998 concerning the conclusion by the European Community of the United Nations Convention of 10 December 1982 on the Law of the Sea and the Agreement of 28 July 1994 relating to the implementation of Part XI thereof (OJ L 179, 23.6.1998, p. 1). (19) OJ L 123, 12.5.2016, p. 1. (20) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (21) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (22) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (23) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1). (24) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (25) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (26) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (27) Regulation (EU) 2017/352 of the European Parliament and of the Council of 15 February 2017 establishing a framework for the provision of port services and common rules on the financial transparency of ports (OJ L 57, 3.3.2017, p. 1). (28) Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea, amending Regulation (EEC) No 2847/93 and repealing Regulation (EC) No 1626/94 (OJ L 409, 30.12.2006, p. 11). (29) Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (OJ L 155, 12.6.2019, p. 1). (30) Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1). (31) Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law (OJ L 328, 6.12.2008, p. 28). (32) Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1). (33) Directive 2014/89/EU of the European Parliament and of the Council of 23 July 2014 establishing a framework for maritime spatial planning (OJ L 257, 28.8.2014, p. 135). (34) Regulation (EU) 2019/1896 of the European Parliament and of the Council of 13 November 2019 on the European Border and Coast Guard and repealing Regulations (EU) No 1052/2013 and (EU) 2016/1624 (OJ L 295, 14.11.2019, p. 1). (35) Regulation (EC) No 1406/2002 of the European Parliament and of the Council of 27 June 2002 establishing a European Maritime Safety Agency (OJ L 208, 5.8.2002, p. 1). (36) Regulation (EU) 2019/473 of the European Parliament and of the Council of 19 March 2019 on the European Fisheries Control Agency (OJ L 83, 25.3.2019, p. 18). (37) Council Decision (EU) 2015/1565 of 14 September 2015 on the approval, on behalf of the European Union, of the Declaration on the granting of fishing opportunities in EU waters to fishing vessels flying the flag of the Bolivarian Republic of Venezuela in the exclusive economic zone off the coast of French Guiana (OJ L 244, 19.9.2015, p. 55). ANNEX I COMMON INDICATORS OF THE EMFAF CORE PERFORMANCE INDICATORS (1) RESULT INDICATORS (MEASUREMENT UNIT) OUTPUT INDICATOR CI 01 - Businesses created CI 02 - Businesses with higher turnover CI 03 - Jobs created CI 04 - Jobs maintained CI 05 - Persons benefitting CI 06 - Actions contributing to a good environmental status, including nature restoration, conservation, protection of ecosystems, biodiversity, animal health and welfare CI 07 - Energy consumption leading to CO2 emissions reduction CI 08 - Number of SMEs supported CR 01 - New production capacity (tonnes/annum) CR 02 - Aquaculture production maintained (tonnes/annum) CR 03 - Businesses created (number of entities) CR 04 - Businesses with higher turnover (number of entities) CR 05 - Capacity of vessels withdrawn (GT and kW) CR 06 - Jobs created (number of persons) CR 07 - Jobs maintained (number of persons) CR 08 - Persons benefitting (number of persons) CR 09 - Area addressed by operations contributing to a good environmental status, protecting, conserving, and restoring biodiversity and ecosystems (km2 or km) CR 10 - Actions contributing to a good environmental status, including nature restoration, conservation, protection of ecosystems, biodiversity, animal health and welfare (number of actions) CR 11 - Entities increasing social sustainability (number of entities) CO 01 - Number of operations CI 09 - Number of fishing vessels equipped with electronic position and catch reporting devices CI 10 - Number of local action groups CI 11 - Number of small scale coastal fishing vessels supported CI12 - Usage of data and information platforms CR 12 - Effectiveness of the system for “collection, management and use of data” (scale: high, medium, low) CR 13 - Cooperation activities between stakeholders (number of actions) CR 14 - Innovations enabled (number of new products, services, processes, business models or methods) CR 15 - Control means installed or improved (number of means) CR 16 - Entities benefitting from promotion and information activities (number of entities) CR 17 - Entities improving resource efficiency in production and/or processing (number of entities) CR 18 - Energy consumption leading to CO2 emissions reduction (kWh/tonnes or litres/h) CR 19 - Actions to improve governance capacity (number of actions) CR 20 - Investment induced (EUR) CR 21 - Datasets and advice made available (number) CR 22 - Usage of data and information platforms (number of page views) (1) Core performance indicators for EMFAF to be used by the Commission in compliance with its reporting requirement pursuant to paragraph (iii) of point (h) of Article 41(3) of the Financial Regulation. ANNEX II ORGANISATION OF SUPPORT UNDER SHARED MANAGEMENT POLICY OBJECTIVE Article 5 of Regulation (EU) 2021/1060 EMFAF PRIORITY EMFAF SPECIFIC OBJECTIVE NOMENCLATURE TO BE USED IN THE FINANCING PLAN Table 11A of Annex V to Regulation (EU) 2021/1060 A greener, low-carbon transitioning towards a net zero carbon economy and resilient Europe by promoting clean and fair energy transition, green and blue investment, the circular economy, climate change mitigation and adaptation, risk prevention and management, and sustainable urban mobility Fostering sustainable fisheries and the restoration and conservation of aquatic biological resources Strengthening economically, socially and environmentally sustainable fishing activities 1.1.1 all operations except those supported under Articles 17 and 19 1.1.2 operations supported under Articles 17 and 19 Increasing energy efficiency and reducing CO2 emissions through the replacement or modernisation of engines of fishing vessels 1.2 Promoting the adjustment of fishing capacity to fishing opportunities in cases of permanent cessation of fishing activities and contributing to a fair standard of living in cases of temporary cessation of fishing activities 1.3 Fostering efficient fisheries control and enforcement, including fighting against IUU fishing, as well as reliable data for knowledge-based decision-making 1.4 Promoting a level-playing field for fishery and aquaculture products from the outermost regions 1.5 Contributing to the protection and restoration of aquatic biodiversity and ecosystems 1.6 Fostering sustainable aquaculture activities, and processing and marketing of fishery and aquaculture products, thus contributing to food security in the Union Promoting sustainable aquaculture activities, especially strengthening the competitiveness of aquaculture production, while ensuring that the activities are environmentally sustainable in the long term 2.1 Promoting marketing, quality and added value of fishery and aquaculture products, as well as processing of those products 2.2 Strengthening international ocean governance and enabling seas and oceans to be safe, secure, clean and sustainably managed Strengthening sustainable sea and ocean management through the promotion of marine knowledge, maritime surveillance or coast guard cooperation 4.1 A Europe closer to citizens by fostering the sustainable and integrated development of all types of territories and local initiatives Enabling a sustainable blue economy in coastal, island and inland areas, and fostering the development of fishing and aquaculture communities Enabling a sustainable blue economy in coastal, island and inland areas, and fostering the sustainable development of fishing and aquaculture communities 3.1 Technical assistance 5.1 5.2 ANNEX III SPECIFIC MAXIMUM AID INTENSITY RATES UNDER SHARED MANAGEMENT ROW NUMBER SPECIFIC CATEGORY OF OPERATION MAXIMUM AID INTENSITY RATE 1 Operations supported under Articles 17, 18 and 19 40 % 2 The following operations contributing to the implementation of the landing obligation referred to in Article 15 of Regulation (EU) No 1380/2013: — operations improving size selectivity or species selectivity of fishing gear; 100 % — operations improving the infrastructure of fishing ports, auction halls, landing sites and shelters in order to facilitate the landing and storage of unwanted catches; 75 % — operations facilitating the marketing of unwanted catches landed from commercial stocks, in accordance with point (b) of Article 8(2) of Regulation (EU) No 1379/2013 75 % 3 Operations aimed at improving the health, safety and working conditions on board fishing vessels, with the exception of operations supported under Article 19 75 % 4 Operations located in the outermost regions 85 % 5 Operations located in the remote Greek Islands and in the Croatian islands of Dugi Otok, Vis, Mljet and Lastovo 85 % 6 Operations supported under Article 22 85 % 7 Operations related to small-scale coastal fishing 100 % 8 Operations for which the beneficiary is a public body or an undertaking entrusted with the operation of services of general economic interest as referred to in Article 106(2) TFEU, where support is granted for the operation of such services 100 % 9 Operations related to the compensation referred to in Article 39 100 % 10 Operations supported under Articles 23 and 25 and under Priority 4 100 % 11 Operations related to the design, development, monitoring, evaluation or management of transparent systems for exchanging fishing opportunities between Member States, in accordance with Article 16(8) of Regulation (EU) No 1380/2013 100 % 12 Operations related to the running costs of local actions groups 100 % 13 Operations supported under Article 30 and which fulfil at least one of the following criteria: (i) they are of collective interest; (ii) they have a collective beneficiary; or (iii) they have innovative features, where appropriate, at local level, and ensure public access to their results 100 % 14 Operations other than those covered in row 13 which fulfil all of the following criteria: (i) they are of collective interest; (ii) they have a collective beneficiary; (iii) they have innovative features or ensure public access to their results 100 % 15 Operations implemented by producer organisations, associations of producer organisations or interbranch organisations 75 % 16 Financial instruments, with the exception of financial instruments related to operations referred to in row 1 100 % 17 Operations supporting sustainable aquaculture implemented by SMEs 60 % 18 Operations supporting innovative products, processes or equipment in fisheries, aquaculture and processing 75 % 19 Operations implemented by organisations of fishers or other collective beneficiaries 60 % ANNEX IV TYPES OF INTERVENTION No TYPE OF INTERVENTION CLIMATE COEFFICIENT ENVIRONMENTAL COEFFICIENT 1 Reducing negative impacts and/or contributing to positive impacts on the environment and contributing to a good environmental status 100 % 100 % 2 Promoting conditions for economically viable, competitive and attractive fishery, aquaculture and processing sectors 40 % 40 % 3 Contributing to climate neutrality 100 % 100 % 4 Temporary cessation of fishing activities 100 % 100 % 5 Permanent cessation of fishing activities 100 % 100 % 6 Contributing to a good environmental status through implementing and monitoring of marine protected areas, including Natura 2000 100 % 100 % 7 Compensation for unexpected environmental, climatic or public health events 0 % 0 % 8 Compensation for additional costs in outermost regions 0 % 0 % 9 Animal health and welfare 40 % 40 % 10 Control and enforcement 40 % 100 % 11 Data collection and analysis, and promotion of marine knowledge 100 % 100 % 12 Maritime surveillance and security 40 % 40 % Community-led local development (CLLD) 13 CLLD preparation actions 0 % 0 % 14 CLLD implementation of strategy 40 % 40 % 15 CLLD running costs and animation 0 % 0 % Technical assistance 16 Technical assistance 0 % 0 % ANNEX V GLOBAL RESOURCES FROM THE EMFAF PER MEMBER STATE FOR THE PERIOD FROM 1 JANUARY 2021 TO 31 DECEMBER 2027 2021 2022 2023 2024 2025 2026 2027 TOTAL TOTAL 649 646 302 867 704 926 833 435 808 798 047 503 707 757 512 721 531 085 732 876 864 5 311 000 000 BE 4 925 394 6 578 640 6 318 823 6 050 521 5 365 973 5 470 400 5 556 420 40 266 171 BG 10 390 512 13 878 165 13 330 060 12 764 057 11 319 949 11 540 245 11 721 710 84 944 698 CZ 3 670 269 4 902 222 4 708 614 4 508 683 3 998 577 4 076 392 4 140 492 30 005 249 DK 24 582 747 32 834 129 31 537 379 30 198 278 26 781 687 27 302 881 27 732 208 200 969 309 DE 25 908 996 34 605 542 33 238 833 31 827 487 28 226 569 28 775 883 29 228 372 211 811 682 EE 11 912 962 15 911 637 15 283 223 14 634 286 12 978 583 13 231 157 13 439 212 97 391 060 IE 17 414 773 23 260 170 22 341 533 21 392 895 18 972 532 19 341 754 19 645 895 142 369 552 EL 45 869 836 61 266 389 58 846 736 56 348 059 49 972 919 50 945 434 51 746 530 374 995 903 ES 137 053 465 183 056 482 175 826 854 168 361 115 149 312 971 152 218 730 154 612 307 1 120 441 924 FR 69 372 651 92 658 097 88 998 661 85 219 712 75 578 071 77 048 886 78 260 448 567 136 526 HR 29 808 019 39 813 303 38 240 917 36 617 179 32 474 362 33 106 342 33 626 925 243 687 047 IT 63 388 749 84 665 656 81 321 871 77 868 885 69 058 907 70 402 853 71 509 909 518 216 830 CY 4 685 786 6 258 605 6 011 428 5 756 178 5 104 932 5 204 279 5 286 114 38 307 322 LV 16 498 239 22 035 996 21 165 707 20 266 995 17 974 015 18 323 805 18 611 939 134 876 696 LT 7 484 030 9 996 101 9 601 315 9 193 636 8 153 481 8 312 155 8 442 859 61 183 577 LU - - - - - - - - HU 4 612 763 6 161 072 5 917 747 5 666 475 5 025 378 5 123 176 5 203 735 37 710 346 MT 2 669 689 3 565 790 3 424 963 3 279 536 2 908 494 2 965 097 3 011 721 21 825 290 NL 11 978 187 15 998 755 15 366 900 14 714 410 13 049 642 13 303 600 13 512 794 97 924 288 AT 821 763 1 097 594 1 054 246 1 009 482 895 270 912 693 927 046 6 718 094 PL 62 675 756 83 713 340 80 407 168 76 993 019 68 282 136 69 610 965 70 705 569 512 387 953 PT 46 307 271 61 850 651 59 407 923 56 885 418 50 449 481 51 431 271 52 240 007 378 572 022 RO 19 871 141 26 541 038 25 492 826 24 410 382 21 648 625 22 069 926 22 416 967 162 450 905 SI 2 927 095 3 909 597 3 755 191 3 595 743 3 188 925 3 250 985 3 302 105 23 929 641 SK 1 862 388 2 487 512 2 389 271 2 287 821 2 028 980 2 068 465 2 100 991 15 225 428 FI 8 777 254 11 723 405 11 260 401 10 782 276 9 562 384 9 748 476 9 901 766 71 755 962 SE 14 176 567 18 935 038 18 187 218 17 414 975 15 444 669 15 745 235 15 992 823 115 896 525

European Maritime, Fisheries and Aquaculture Fund (2021–2027) European Maritime, Fisheries and Aquaculture Fund (2021–2027) SUMMARY OF: Regulation (EU) 2021/1139 establishing the European Maritime, Fisheries and Aquaculture Fund WHAT IS THE AIM OF THE REGULATION? It establishes the European Maritime, Fisheries and Aquaculture Fund (EMFAF), a European Union (EU) fund which runs over the 2021–2027 period in the context of the 2021–2027 multiannual financial framework. It sets out the fund’s priorities, its budget and the specific rules for providing EU funding, complementary to the general rules applying to the EMFAF under Regulation (EU) 2021/1060 (see summary). KEY POINTS Priorities The EMFAF supports the EU’s common fisheries policy, the EU maritime policy and the EU agenda for international ocean governance. This helps to fulfil the objectives of the European Green Deal and contributes to the protection of marine biodiversity, to the EU’s climate change mitigation objectives and to food supply. The EMFAF supports innovative projects that contribute to the sustainable use and management of aquatic and maritime resources. In particular, it facilitates: sustainable and low-carbon fishing activities; the protection of marine biodiversity and ecosystems; the supply of quality and healthy seafood to European consumers through an efficient market for fisheries products; the socioeconomic attractiveness and generational renewal of the fisheries sector, in particular as regards small-scale coastal fisheries; the structural management of fisheries and fishing fleets (eliminating fleet overcapacity and supporting measures for the conservation of marine biological resources); the collection of scientific data to underpin fisheries management; the control of fishing activities and the promotion of a culture of compliance in the fishing sector, to ensure a level playing field; the development of sustainable and competitive aquaculture, contributing to food security; the improvement of skills and working conditions in fisheries and aquaculture; the economic and social vitality of coastal communities; innovation in the sustainable blue economy; maritime security, contributing to a safe maritime space; international cooperation, contributing to healthy, safe and sustainably managed oceans. In pursuing these objectives, the EMFAF has a specific focus on the sustainability and profitability of small-scale coastal fishing and on the sustainable development of maritime activities in the outermost regions. Budget For 2021–2027, the EMFAF budget is €6,108,000,000 (at 2021 prices), divided as follows: shared management — €5,311,000,000 provided through national programmes co-financed by the EU budget and the EU Member States; direct and indirect management — €797,000,000 provided by the European Commission. Annex V lists the global resources from the EMFAF per Member State for each of the years from 2021 to 2027. For operations in the outermost regions, the Member States concerned must allocate from these global amounts at least: €102,000,000 for the Azores and Madeira (Portugal); €82,000,000 for the Canary Islands (Spain); €131,000,000 for French Guiana, Guadeloupe, Martinique, Mayotte, Réunion and Saint Martin (France). Programming Under shared management, each Member State prepares a single national programme, which the Commission approves after an in-depth assessment. A national EMFAF programme is a strategic roadmap for public investment between 2021 and 2027. It describes tailor-made actions to respond to the specific challenges identified by the Member States as regards the common EU priorities for marine biodiversity, maritime policy and sustainable fisheries and aquaculture. Evaluation and monitoring The EMFAF’s implementation is continuously monitored in a transparent manner, in accordance with the common rules set in Regulation (EU) 2021/1060 and the specific rules in the EMFAF regulation. Twice each year, Member States report: on the values of the indicators selected in their EMFAF programmes — this information is aggregated at EU level and made publicly available;on the detailed characteristics of each project and beneficiary — the Commission uses this information for regular ad hoc reporting. Five times each year, Member States report on the number of selected projects and on their financial cost. This information is aggregated at EU level and made publicly available. It is also broken down according to thematic areas. The Commission discusses the EMFAF’s implementation with each Member State in an annual review meeting. This meeting aims to identify potential issues in the national EMFAF programme and corrective actions, if necessary. By 30 June 2029, each Member State will evaluate its EMFAF programme to assess its impact. By the end of 2024 and also by the end of 2031, the Commission will evaluate the effectiveness, efficiency, relevance, coherence and EU added value of the EMFAF as a whole. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND For more information, see: European Maritime, Fisheries and Aquaculture Fund (EMFAF) (European Commission). MAIN DOCUMENT Regulation (EU) 2021/1139 of the European Parliament and of the Council of 7 July 2021 establishing the European Maritime, Fisheries and Aquaculture Fund and amending Regulation (EU) 2017/1004 (OJ L 247, 13.7.2021, pp. 1–49). RELATED DOCUMENTS Commission Delegated Regulation (EU) 2021/1972 of 11 August 2021 supplementing Regulation (EU) 2021/1139 of the European Parliament and of the Council establishing the European Maritime, Fisheries and Aquaculture Fund and amending Regulation (EU) 2017/1004 by laying down the criteria for the calculation of the additional costs incurred by operators in the fishing, farming, processing and marketing of certain fishery and aquaculture products from the outermost regions (OJ L 402, 15.11.2021, pp. 1–3). Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, pp. 159–706). Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions — on a new approach for a sustainable blue economy in the EU — Transforming the EU’s Blue Economy for a Sustainable Future (COM(2021) 240 final, 17.5.2021). Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions — EU Biodiversity Strategy for 2030 — Bringing nature back into our lives (COM(2020) 380 final, 20.5.2020). Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions — The European Green Deal (COM(2019) 640 final, 11.12.2019). Regulation (EU) 2017/1004 of the European Parliament and of the Council of 17 May 2017 on the establishment of a Union framework for the collection, management and use of data in the fisheries sector and support for scientific advice regarding the common fisheries policy and repealing Council Regulation (EC) No 199/2008 (OJ L 157, 20.6.2017, pp. 1–21). Successive amendments to Regulation (EU) 2017/1004 have been incorporated into the original text. This consolidated version is of documentary value only. Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (OJ L 354, 28.12.2013, pp. 1–21). See consolidated version. Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, pp. 1–50). See consolidated version. Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, pp. 19–40). See consolidated version. last update 26.11.2021

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7.6.2019 EN Official Journal of the European Union L 151/70 DIRECTIVE (EU) 2019/882 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 April 2019 on the accessibility requirements for products and services (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The purpose of this Directive is to contribute to the proper functioning of the internal market by approximating laws, regulations and administrative provisions of the Member States as regards accessibility requirements for certain products and services by, in particular, eliminating and preventing barriers to the free movement of certain accessible products and services arising from divergent accessibility requirements in the Member States. This would increase the availability of accessible products and services in the internal market and improve the accessibility of relevant information. (2) The demand for accessible products and services is high and the number of persons with disabilities is projected to increase significantly. An environment where products and services are more accessible allows for a more inclusive society and facilitates independent living for persons with disabilities. In this context, it should be borne in mind that the prevalence of disability in the Union is higher among women than among men. (3) This Directive defines persons with disabilities in line with the United Nations Convention on the Rights of Persons with Disabilities, adopted on 13 December 2006 (UN CRPD), to which the Union has been a Party since 21 January 2011 and which all Member States have ratified. The UN CRPD states that persons with disabilities ‘include those who have long-term physical, mental, intellectual or sensory impairments which in interaction with various barriers may hinder their full and effective participation in society on an equal basis with others’. This Directive promotes full and effective equal participation by improving access to mainstream products and services that, through their initial design or subsequent adaptation, address the particular needs of persons with disabilities. (4) Other persons who experience functional limitations, such as elderly persons, pregnant women or persons travelling with luggage, would also benefit from this Directive. The concept of ‘persons with functional limitations’, as referred to in this Directive, includes persons who have any physical, mental, intellectual or sensory impairments, age related impairments, or other human body performance related causes, permanent or temporary, which, in interaction with various barriers, result in their reduced access to products and services, leading to a situation that requires those products and services to be adapted to their particular needs. (5) The disparities between the laws, regulations and administrative provisions of Member States concerning the accessibility of products and services for persons with disabilities, create barriers to the free movement of products and services and distort effective competition in the internal market. For some products and services, those disparities are likely to increase in the Union after the entry into force of the UN CRPD. Economic operators, in particular small and medium-sized enterprises (SMEs), are particularly affected by those barriers. (6) Due to the differences in national accessibility requirements, individual professionals, SMEs and microenterprises in particular are discouraged from entering into business ventures outside their own domestic markets. The national, or even regional or local, accessibility requirements that Member States have put in place currently differ as regards both coverage and level of detail. Those differences negatively affect competitiveness and growth, due to the additional costs incurred in the development and marketing of accessible products and services for each national market. (7) Consumers of accessible products and services and of assistive technologies, are faced with high prices due to limited competition among suppliers. Fragmentation among national regulations reduces potential benefits derived from sharing with national and international peers experiences concerning responding to societal and technological developments. (8) The approximation of national measures at Union level is therefore necessary for the proper functioning of the internal market in order to put an end to fragmentation in the market of accessible products and services, to create economies of scale, to facilitate cross-border trade and mobility, as well as to help economic operators to concentrate resources on innovation instead of using those resources to cover expenses arising from fragmented legislation across the Union. (9) The benefits of harmonising accessibility requirements for the internal market have been demonstrated by the application of Directive 2014/33/EU of the European Parliament and of the Council (3) regarding lifts and Regulation (EC) No 661/2009 of the European Parliament and of the Council (4) in the area of transport. (10) In Declaration No 22, regarding persons with a disability, annexed to the Treaty of Amsterdam, the Conference of the Representatives of the Governments of the Member States agreed that, in drawing up measures under Article 114 of the Treaty on the Functioning of the European Union (TFEU), the institutions of the Union are to take account of the needs of persons with disabilities. (11) The overall aim of the communication of the Commission of 6 May 2015‘A Digital Single Market Strategy for Europe’, is to deliver sustainable economic and social benefits from a connected digital single market, thereby facilitating trade and promoting employment within the Union. Union consumers still do not enjoy the full benefits of prices and choice that the single market can offer, because cross-border online transactions are still very limited. Fragmentation also limits demand for cross-border e-commerce transactions. There is also a need for concerted action to ensure that electronic content, electronic communications services and access to audiovisual media services are fully available to persons with disabilities. It is therefore necessary to harmonise accessibility requirements across the digital single market and to ensure that all Union citizens, regardless of their abilities, can enjoy its benefits. (12) Since the Union became a Party to the UN CRPD, its provisions have become an integral part of the Union legal order and are binding upon the institutions of the Union and on its Member States. (13) The UN CRPD requires its Parties to take appropriate measures to ensure that persons with disabilities have access, on an equal basis with others, to the physical environment, to transportation, to information and communications, including information and communications technologies and systems, and to other facilities and services open or provided to the public, both in urban and in rural areas. The United Nations Committee on the Rights of Persons with Disabilities has identified the need to create a legislative framework with concrete, enforceable and time-bound benchmarks for monitoring the gradual implementation of accessibility. (14) The UN CRPD calls on its Parties to undertake or promote research and development of, and to promote the availability and use of, new technologies, including information and communications technologies, mobility aids, devices and assistive technologies, suitable for persons with disabilities. The UN CRPD also calls for priority to be given to affordable technologies. (15) The entry into force of the UN CRPD in the Member States’ legal orders entails the need to adopt additional national provisions on accessibility of products and services. Without Union action, those provisions would further increase disparities between the laws, regulations and administrative provisions of the Member States. (16) It is therefore necessary to facilitate the implementation in the Union of the UN CRPD by providing common Union rules. This Directive also supports Member States in their efforts to fulfil their national commitments, as well as their obligations under the UN CRPD regarding accessibility in a harmonised manner. (17) The communication of the Commission of 15 November 2010‘European Disability Strategy 2010-2020 – A Renewed Commitment to a Barrier-Free Europe’ – in line with the UN CRPD, identifies accessibility as one of the eight areas of action, indicates that it is a basic precondition for participation in society, and aims to ensure the accessibility of products and services. (18) The determination of the products and services falling within the scope of this Directive is based on a screening exercise which was carried out during the preparation of the Impact Assessment that identified relevant products and services for persons with disabilities, and for which Member States have adopted or are likely to adopt diverging national accessibility requirements disruptive to the functioning of the internal market. (19) In order to ensure the accessibility of the services falling within the scope of this Directive, products used in the provision of those services with which the consumer interacts should also be required to comply with the applicable accessibility requirements of this Directive. (20) Even if a service, or part of a service, is subcontracted to a third party, the accessibility of that service should not be compromised and the service providers should comply with the obligations of this Directive. Service providers should also ensure proper and continuous training of their personnel in order to ensure that they are knowledgeable about how to use accessible products and services. That training should cover issues such as information provision, advice and advertising. (21) Accessibility requirements should be introduced in the manner that is least burdensome for the economic operators and the Member States. (22) It is necessary to specify accessibility requirements for the placing on the market of products and services which fall within the scope of this Directive, in order to ensure their free movement in the internal market. (23) This Directive should make functional accessibility requirements compulsory and they should be formulated in terms of general objectives. Those requirements should be precise enough to create legally binding obligations and sufficiently detailed so as to make it possible to assess conformity in order to ensure the good functioning of the internal market for the products and services covered by this Directive, as well as leave a certain degree of flexibility in order to allow for innovation. (24) This Directive contains a number of functional performance criteria related to modes of operations of products and services. Those criteria are not meant as a general alternative to the accessibility requirements of this Directive but should be used in very specific circumstances only. Those criteria should apply to specific functions or features of the products or services, to make them accessible, when the accessibility requirements of this Directive do not address one or more of those specific functions or features. In addition, in the event that an accessibility requirement contains specific technical requirements, and an alternative technical solution for those technical requirements is provided in the product or service, this alternative technical solution should still comply with the related accessibility requirements, and should result in equivalent or increased accessibility, by applying the relevant functional performance criteria. (25) This Directive should cover consumer general purpose computer hardware systems. For those systems to perform in an accessible manner, their operating systems should also be accessible. Such computer hardware systems are characterised by their multipurpose nature and their ability to perform, with the appropriate software, the most common computing tasks requested by consumers and are intended to be operated by consumers. Personal computers, including desktops, notebooks, smartphones and tablets are examples of such computer hardware systems. Specialised computers embedded in consumer electronics products do not constitute consumer general purpose computer hardware systems. This Directive should not cover, on an individual basis, single components with specific functions, such as a mainboard or a memory chip, that are used or that might be used in such a system. (26) This Directive should also cover payment terminals, including both their hardware and software, and certain interactive self-service terminals, including both their hardware and software, dedicated to be used for the provision of services covered by this Directive: for example automated teller machines; ticketing machines issuing physical tickets granting access to services such as travel ticket dispensers; bank office queuing ticket machines; check-in machines; and interactive self-service terminals providing information, including interactive information screens. (27) However, certain interactive self-service terminals providing information installed as integrated parts of vehicles, aircrafts, ships or rolling stock should be excluded from the scope of this Directive, since these form part of those vehicles, aircrafts, ships or rolling stock which are not covered by this Directive. (28) This Directive should also cover electronic communications services including emergency communications as defined in Directive (EU) 2018/1972 of the European Parliament and of the Council (5). At present, the measures taken by Member States to provide access to persons with disabilities are divergent and are not harmonised throughout the internal market. Ensuring that the same accessibility requirements apply throughout the Union will lead to economies of scale for economic operators active in more than one Member State and facilitate the effective access for persons with disabilities, both in their own Member State and when travelling between Member States. For electronic communications services including emergency communications to be accessible, providers should, in addition to voice, provide real time text, and total conversation services where video is provided by them, ensuring the synchronisation of all those communication means. Member States should, in addition to the requirements of this Directive, in accordance with Directive (EU) 2018/1972, be able to determine a relay service provider that could be used by persons with disabilities. (29) This Directive harmonises accessibility requirements for electronic communications services and related products and complements Directive (EU) 2018/1972 which sets requirements on equivalent access and choice for end-users with disabilities. Directive (EU) 2018/1972 also sets requirements under universal service obligations on the affordability of internet access and voice communications and on the affordability and availability of related terminal equipment, specific equipment and services for consumers with disabilities. (30) This Directive should also cover consumer terminal equipment with interactive computing capability foreseeably to be primarily used to access electronic communications services. For the purposes of this Directive that equipment should be deemed to include equipment used as part of the setup in accessing electronic communications services such as a router or a modem. (31) For the purposes of this Directive, access to audiovisual media services should mean that the access to audiovisual content is accessible, as well as mechanisms that allow users with disabilities to use their assistive technologies. Services providing access to audiovisual media services could include websites, online applications, set-top box-based applications, downloadable applications, mobile device-based services including mobile applications and related media players as well as connected television services. Accessibility of audiovisual media services is regulated in Directive 2010/13/EU of the European Parliament and of the Council (6), with the exception of the accessibility of electronic programme guides (EPGs) which are included in the definition of services providing access to audiovisual media services to which this Directive applies. (32) In the context of air, bus, rail and waterborne passenger transport services this Directive should cover, inter alia, the delivery of transport service information including real-time travel information through websites, mobile device-based services, interactive information screens and interactive self-service terminals, required by passengers with disabilities in order to travel. This could include information about the service provider’s passenger transport products and services, pre-journey information, information during the journey and information provided when a service is cancelled or its departure is delayed. Other elements of information could also include information on prices and promotions. (33) This Directive should also cover websites, mobile device-based services including mobile applications developed or made available by operators of passenger transport services within the scope of this Directive or on their behalf, electronic ticketing services, electronic tickets and interactive self-service terminals. (34) The determination of the scope of this Directive with regard to air, bus, rail and waterborne passenger transport services should be based on the existing sectorial legislation relating to passenger rights. Where this Directive does not apply to certain types of transport services, Member States should encourage service providers to apply the relevant accessibility requirements of this Directive. (35) Directive (EU) 2016/2102 of the European Parliament and of the Council (7) already lays down obligations for public sector bodies providing transport services, including urban and suburban transport services and regional transport services, to make their websites accessible. This Directive contains exemptions for microenterprises providing services, including urban and suburban transport services and regional transport services. In addition, this Directive includes obligations to ensure that e-commerce websites are accessible. Since this Directive contains obligations for the large majority of private transport service providers to make their websites accessible, when selling tickets online, it is not necessary to introduce in this Directive further requirements for the websites of urban and suburban transport service providers and regional transport service providers. (36) Certain elements of the accessibility requirements, in particular in relation to the provision of information as set out in this Directive, are already covered by existing Union law in the field of passenger transport. This includes elements of Regulation (EC) No 261/2004 of the European Parliament and of the Council (8), Regulation (EC) No 1107/2006 of the European Parliament and of the Council (9), Regulation (EC) No 1371/2007 of the European Parliament and of the Council (10), Regulation (EU) No 1177/2010 of the European Parliament and of the Council (11) and Regulation (EU) No 181/2011 of the European Parliament and of the Council (12). This includes also relevant acts adopted on the basis of Directive 2008/57/EC of the European Parliament and of the Council (13). To ensure regulatory consistency, the accessibility requirements set out in those Regulations and those acts should continue to apply as before. However, additional requirements of this Directive would supplement the existing requirements, improving the functioning of the internal market in the area of transport and benefiting persons with disabilities. (37) Certain elements of transport services should not be covered by this Directive when provided outside the territory of the Member States even where the service has been directed towards the Union market. With regard to those elements, a passenger transport service operator should only be obliged to ensure that the requirements of this Directive are met with regard to the part of the service offered within the territory of the Union. However, in the case of air transport, Union air carriers should ensure that the applicable requirements of this Directive are also satisfied on flights departing from an airport situated in a third country and flying to an airport situated within the territory of a Member State. Furthermore, all air carriers, including those which are not licenced in the Union, should ensure that the applicable requirements of this Directive are satisfied in cases where the flights depart from a Union territory to a third country territory. (38) Urban authorities should be encouraged to integrate barrier-free accessibility to urban transport services in their Sustainable Urban Mobility Plans (SUMPs), as well as to regularly publish lists of best practices regarding barrier-free accessibility to urban public transport and mobility. (39) Union law on banking and financial services aims to protect and provide information to consumers of those services across the Union but does not include accessibility requirements. With a view to enabling persons with disabilities to use those services throughout the Union, including where provided through websites and mobile device-based services including mobile applications, to make well-informed decisions, and to feel confident that they are adequately protected on an equal basis with other consumers, as well as ensure a level playing field for service providers, this Directive should establish common accessibility requirements for certain banking and financial services provided to consumers. (40) The appropriate accessibility requirements should also apply to identification methods, electronic signature and payment services, since they are necessary for concluding consumer banking transactions. (41) E-book files are based on a electronic computer coding that enables the circulation and consultation of a mostly textual and graphical intellectual work. The degree of precision of this coding determines the accessibility of e-book files, in particular regarding the qualification of the different constitutive elements of the work and the standardised description of its structure. The interoperability in terms of accessibility should optimise the compatibility of those files with the user agents and with current and future assistive technologies. Specific features of special volumes like comics, children’s books and art books should be considered in the light of all applicable accessibility requirements. Divergent accessibility requirements in Member States would make it difficult for publishers and other economic operators to benefit from the advantages of the internal market, could create interoperability problems with e-readers and would limit the access for consumers with disabilities. In the context of e-books, the concept of a service provider could include publishers and other economic operators involved in their distribution. It is recognised that persons with disabilities continue to face barriers to accessing content which is protected by copyright and related rights, and that certain measures have already been taken to address this situation for example through the adoption of Directive (EU) 2017/1564 of the European Parliament and of the Council (14) and Regulation (EU) 2017/1563 of the European Parliament and of the Council (15), and that further Union measures could be taken in this respect in the future. (42) This Directive defines e-commerce services as a service provided at a distance, through websites and mobile device-based services, by electronic means and at the individual request of a consumer, with a view to concluding a consumer contract. For the purposes of that definition ‘at a distance’ means that the service is provided without the parties being simultaneously present; ‘by electronic means’ means that the service is initially sent and received at its destination by means of electronic equipment for the processing (including digital compression) and storage of data, and transmitted, conveyed and received in its entirety by wire, by radio, by optical means or by other electromagnetic means; ‘at the individual request of a consumer’ means that the service is provided on individual request. Given the increased relevance of e-commerce services and their high technological nature, it is important to have harmonised requirements for their accessibility. (43) The e-commerce services accessibility obligations of this Directive should apply to the online sale of any product or service and should therefore also apply to the sale of a product or service covered in its own right under this Directive. (44) The measures related to the accessibility of the answering of emergency communications should be adopted without prejudice to, and should have no impact on, the organisation of emergency services, which remains in the exclusive competence of Member States. (45) In accordance with Directive (EU) 2018/1972, Member States are to ensure that access for end-users with disabilities to emergency services is available through emergency communications and is equivalent to that enjoyed by other end-users, in accordance with Union law harmonising accessibility requirements for products and services. The Commission and the national regulatory or other competent authorities are to take appropriate measures to ensure that, whilst travelling in another Member State, end-users with disabilities can access emergency services on an equivalent basis with other end-users, where feasible without any pre-registration. Those measures seek to ensure interoperability across Member States and are to be based, to the greatest extent possible, on European standards or specifications laid down in accordance with Article 39 of Directive (EU) 2018/1972. Such measures do not prevent Member States from adopting additional requirements in order to pursue the objectives set out in that Directive. As an alternative to fulfilling the accessibility requirements with regard to the answering of emergency communications for users with disabilities set out in this Directive, Member States should be able to determine a third party relay service provider to be used by persons with disabilities to communicate with the public safety answering point, until those public safety answering points are capable of using electronic communications services through internet protocols for ensuring accessibility of answering the emergency communications. In any case, obligations of this Directive should not be understood to restrict or lower any obligations for the benefit of end-users with disabilities, including equivalent access to electronic communications services and emergency services as well as accessibility obligations as set out in Directive (EU) 2018/1972. (46) Directive (EU) 2016/2102 defines accessibility requirements for websites and mobile applications of public sector bodies and other related aspects, in particular requirements relating to the compliance of the relevant websites and mobile applications. However, that Directive contains a specific list of exceptions. Similar exceptions are relevant for this Directive. Some activities that take place via websites and mobile applications of public sector bodies, such as passenger transport services or e-commerce services, which fall within the scope of this Directive, should in addition comply with the applicable accessibility requirements of this Directive in order to ensure that the online sale of products and services is accessible for persons with disabilities irrespective whether the seller is a public or private economic operator. The accessibility requirements of this Directive should be aligned to the requirements of Directive (EU) 2016/2102, despite differences, for example, in monitoring, reporting and enforcement. (47) The four principles of accessibility of websites and mobile applications, as used in Directive (EU) 2016/2102, are: perceivability, meaning that information and user interface components must be presentable to users in ways they can perceive; operability, meaning that user interface components and navigation must be operable; understandability, meaning that information and the operation of the user interface must be understandable; and robustness, meaning that content must be robust enough to be interpreted reliably by a wide variety of user agents, including assistive technologies. Those principles are also relevant for this Directive. (48) Member States should take all appropriate measures to ensure that, where the products and services covered by this Directive comply with the applicable accessibility requirements, their free movement within the Union is not impeded for reasons related to accessibility requirements. (49) In some situations, common accessibility requirements of the built environment would facilitate the free movement of the related services and of persons with disabilities. Therefore, this Directive should enable Member States to include the built environment used in the provision of the services under the scope of this Directive, ensuring compliance with the accessibility requirements set out in Annex III. (50) Accessibility should be achieved by the systematic removal and prevention of barriers, preferably through a universal design or ‘design for all’ approach, which contributes to ensuring access for persons with disabilities on an equal basis with others. According to the UN CRPD, that approach ‘means the design of products, environments, programmes and services to be usable by all people, to the greatest extent possible, without the need for adaptation or specialized design’. In line with the UN CRPD, ’‘universal design’ shall not exclude assistive devices for particular groups of persons with disabilities where this is needed’. Furthermore, accessibility should not exclude the provision of reasonable accommodation when required by Union law or national law. Accessibility and universal design should be interpreted in line with General Comment No 2(2014) – Article 9: Accessibility as written by the Committee on the Rights of Persons with Disabilities. (51) Products and services falling within the scope of this Directive do not automatically fall within the scope of Council Directive 93/42/EEC (16). However, some assistive technologies which are medical devices, might fall within the scope of that Directive. (52) Most jobs in the Union are provided by SMEs and microenterprises. They have a crucial importance for future growth, but very often face hurdles and obstacles in developing their products or services, in particular in the cross-border context. It is therefore necessary to facilitate the work of the SMEs and microenterprises by harmonising the national provisions on accessibility while maintaining the necessary safeguards. (53) For microenterprises and SMEs to benefit from this Directive they must genuinely fulfil the requirements of Commission Recommendation 2003/361/EC (17), and the relevant case law, aimed at preventing the circumvention of its rules. (54) In order to ensure the consistency of Union law, this Directive should be based on Decision No 768/2008/EC of the European Parliament and of the Council (18), since it concerns products already subject to other Union acts, while recognising the specific features of the accessibility requirements of this Directive. (55) All economic operators falling within the scope of this Directive and intervening in the supply and distribution chain should ensure that they make available on the market only products which are in conformity with this Directive. The same should apply to economic operators providing services. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution process. (56) Economic operators should be responsible for the compliance of products and services, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of accessibility and to guarantee fair competition on the Union market. (57) The obligations of this Directive should apply equally to economic operators from the public and private sectors. (58) The manufacturer having detailed knowledge of the design and production process is best placed to carry out the complete conformity assessment. While the responsibility for the conformity of products rests with the manufacturer, market surveillance authorities should play a crucial role in checking whether products made available in the Union are manufactured in accordance with Union law. (59) Importers and distributors and should be involved in market surveillance tasks carried out by national authorities, and should participate actively, providing the competent authorities with all necessary information relating to the product concerned. (60) Importers should ensure that products from third countries entering the Union market comply with this Directive and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those products. (61) When placing a product on the market, importers should indicate, on the product, their name, registered trade name or registered trade mark and the address at which they can be contacted. (62) Distributors should ensure that their handling of the product does not adversely affect the compliance of the product with the accessibility requirements of this Directive. (63) Any economic operator that either places a product on the market under its name or trademark or modifies a product already placed on the market in such a way that compliance with applicable requirements might be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer. (64) For reasons of proportionality, accessibility requirements should only apply to the extent that they do not impose a disproportionate burden on the economic operator concerned, or to the extent that they do not require a significant change in the products and services which would result in their fundamental alteration in the light of this Directive. Control mechanisms should nevertheless be in place in order to verify entitlement to exceptions to the applicability of accessibility requirements. (65) This Directive should follow the principle of ‘think small first’ and should take account of the administrative burdens that SMEs are faced with. It should set light rules in terms of conformity assessment and should establish safeguard clauses for economic operators, rather than providing for general exceptions and derogations for those enterprises. Consequently, when setting up the rules for the selection and implementation of the most appropriate conformity assessment procedures, the situation of SMEs should be taken into account and the obligations to assess conformity of accessibility requirements should be limited to the extent that they do not impose a disproportionate burden on SMEs. In addition, market surveillance authorities should operate in a proportionate manner in relation to the size of undertakings and to the small serial or non-serial nature of the production concerned, without creating unnecessary obstacles for SMEs and without compromising the protection of public interest. (66) In exceptional cases, where the compliance with accessibility requirements of this Directive would impose a disproportionate burden on economic operators, economic operators should only be required to comply with those requirements to the extent that they do not impose a disproportionate burden. In such duly justified cases, it would not be reasonably possible for an economic operator to fully apply one or more of the accessibility requirements of this Directive. However, the economic operator should make a service or a product that falls within the scope of this Directive as accessible as possible by applying those requirements to the extent that they do not impose a disproportionate burden. Those accessibility requirements which were not considered by the economic operator to impose a disproportionate burden should apply fully. Exceptions to compliance with one or more accessibility requirements due to the disproportionate burden that they impose should not go beyond what is strictly necessary in order to limit that burden with respect to the particular product or service concerned in each individual case. Measures that would impose a disproportionate burden should be understood as measures that would impose an additional excessive organisational or financial burden on the economic operator, while taking into account the likely resulting benefit for persons with disabilities in line with the criteria set out in this Directive. Criteria based on these considerations should be defined in order to enable both economic operators and relevant authorities to compare different situations and to assess in a systematic way whether a disproportionate burden exists. Only legitimate reasons should be taken into account in any assessment of the extent to which the accessibility requirements cannot be met because they would impose a disproportionate burden. Lack of priority, time or knowledge should not be considered to be legitimate reasons. (67) The overall assessment of a disproportionate burden should be done using the criteria set out in Annex VI. The assessment of disproportionate burden should be documented by the economic operator taking into account the relevant criteria. Service providers should renew their assessment of a disproportionate burden at least every five years. (68) The economic operator should inform the relevant authorities that it has relied on the provisions of this Directive related to fundamental alteration and/or disproportionate burden. Only upon a request from the relevant authorities should the economic operator provide a copy of the assessment explaining why its product or service is not fully accessible and providing evidence of the disproportionate burden or fundamental alteration, or both. (69) If on the basis of the required assessment, a service provider concludes that it would constitute a disproportionate burden to require that all self-service terminals, used in the provision of services covered by this Directive, comply with the accessibility requirements of this Directive, the service provider should still apply those requirements to the extent that those requirements do not impose such a disproportionate burden on it. Consequently, the service providers should assess the extent to which a limited level of accessibility in all self-service terminals or a limited number of fully accessible self-service terminals would enable them to avoid a disproportionate burden that would otherwise be imposed on them, and should be required to comply with the accessibility requirements of this Directive only to that extent. (70) Microenterprises are distinguished from all other undertakings by their limited human resources, annual turnover or annual balance sheet. The burden of complying with the accessibility requirements for microenterprises therefore, in general, takes a greater share of their financial and human resources than for other undertakings and is more likely to represent a disproportionate share of the costs. A significant proportion of cost for microenterprises comes from completing or keeping paperwork and records to demonstrate compliance with the different requirements set out in Union law. While all economic operators covered by this Directive should be able to assess the proportionality of complying with the accessibility requirements of this Directive and should only comply with them to the extent they are not disproportionate, demanding such an assessment from microenterprises providing services would in itself constitute a disproportionate burden. The requirements and obligations of this Directive should therefore not apply to microenterprises providing services within the scope of this Directive. (71) For microenterprises dealing with products falling within the scope of this Directive the requirements and obligations of this Directive should be lighter in order to reduce the administrative burden. (72) While some microenterprises are exempted from the obligations of this Directive, all microenterprises should be encouraged to manufacture, import or distribute products and to provide services that comply with the accessibility requirements of this Directive, in order to increase their competitiveness as well as their growth potential in the internal market. Member States should, therefore, provide guidelines and tools to microenterprises to facilitate the application of national measures transposing this Directive. (73) All economic operators should act responsibly and in full accordance with the legal requirements applicable when placing or making products available on the market or providing services on the market. (74) In order to facilitate the assessment of conformity with the applicable accessibility requirements it is necessary to provide for a presumption of conformity for products and services which are in conformity with voluntary harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council (19) for the purpose of drawing up detailed technical specifications of those requirements. The Commission has already issued a number of standardisation requests to the European standardisation organisations on accessibility, such as standardisation mandates M/376, M/473 and M/420, which would be relevant for the preparation of harmonised standards. (75) Regulation (EU) No 1025/2012 provides for a procedure for formal objections to harmonised standards that are considered not to comply with the requirements of this Directive. (76) European standards should be market-driven, take into account the public interest, as well as the policy objectives clearly stated in the Commission’s request to one or more European standardisation organisations to draft harmonised standards, and be based on consensus. In the absence of harmonised standards and where needed for internal market harmonisation purposes, the Commission should be able to adopt in certain cases implementing acts establishing technical specifications for the accessibility requirements of this Directive. Recourse to technical specifications should be limited to such cases. The Commission should be able to adopt technical specifications for instance when the standardisation process is blocked due to a lack of consensus between stakeholders or there are undue delays in the establishment of a harmonised standard, for example because the required quality is not reached. The Commission should leave enough time between the adoption of a request to one or more European standardisation organisations to draft harmonised standards and the adoption of a technical specification related to the same accessibility requirement. The Commission should not be allowed to adopt a technical specification if it has not previously tried to have the accessibility requirements covered through the European standardisation system, except where the Commission can demonstrate that the technical specifications respect the requirements laid down in Annex II of Regulation (EU) No 1025/2012. (77) With a view to establishing, in the most efficient way, harmonised standards and technical specifications that meet the accessibility requirements of this Directive for products and services, the Commission should, where this is feasible, involve European umbrella organisations of persons with disabilities and all other relevant stakeholders in the process. (78) To ensure effective access to information for market surveillance purposes, the information required to declare compliance with all applicable Union acts should be made available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, they should be able to include in the single EU declaration of conformity all relevant individual declarations of conformity. (79) For conformity assessment of products, this Directive should use the Internal production control of ‘Module A’, set out in Annex II to Decision No 768/2008/EC, as it enables economic operators to demonstrate, and the competent authorities to ensure, that products made available on the market conform to the accessibility requirements while not imposing an undue burden. (80) When carrying out market surveillance of products and checking compliance of services, authorities should also check the conformity assessments, including whether the relevant assessment of fundamental alteration or disproportionate burden was properly carried out. When carrying out their duties authorities should also do so in cooperation with persons with disabilities and the organisations that represent them and their interests. (81) For services, the information necessary to assess conformity with the accessibility requirements of this Directive should be provided in the general terms and conditions, or in an equivalent document, without prejudice to Directive 2011/83/EU of the European Parliament and of the Council (20). (82) The CE marking, indicating the conformity of a product with the accessibility requirements of this Directive, is the visible consequence of a whole process comprising conformity assessment in a broad sense. This Directive should follow the general principles governing the CE marking of Regulation (EC) No 765/2008 of the European Parliament and of the Council (21) setting out the requirements for accreditation and market surveillance relating to the marketing of products. In addition to making the EU declaration of conformity, the manufacturer should inform consumers in a cost-effective manner about the accessibility of their products. (83) In accordance with Regulation (EC) No 765/2008, by affixing the CE marking to a product, the manufacturer declares that the product is in conformity with all applicable accessibility requirements and that the manufacturer takes full responsibility therefor. (84) In accordance with Decision No 768/2008/EC, Member States are responsible for ensuring strong and efficient market surveillance of products in their territories and should allocate sufficient powers and resources to their market surveillance authorities. (85) Member States should check the compliance of services with the obligations of this Directive and should follow up complaints or reports related to non-compliance in order to ensure that corrective action has been taken. (86) Where appropriate the Commission, in consultation with stakeholders, could adopt non-binding guidelines to support coordination among market surveillance authorities and authorities responsible for checking compliance of services. The Commission and Member States should be able to set up initiatives for the purpose of sharing the resources and expertise of authorities. (87) Member States should ensure that market surveillance authorities and authorities responsible for checking compliance of services check the compliance of the economic operators with the criteria set out in Annex VI in accordance with Chapters VIII and IX. Member States should be able to designate a specialised body for carrying out the obligations of market surveillance authorities or authorities responsible for checking compliance of services under this Directive. Member States should be able to decide that the competences of such a specialised body should be limited to the scope of this Directive or certain parts thereof, without prejudice to the Member States’ obligations under Regulation (EC) No 765/2008. (88) A safeguard procedure should be set up to apply in the event of disagreement between Member States over measures taken by a Member State under which interested parties are informed of measures intended to be taken with regard to products not complying with the accessibility requirements of this Directive. The safeguard procedure should allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such products. (89) Where the Member States and the Commission agree that a measure taken by a Member State is justified, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings in the harmonised standards or in the technical specifications. (90) Directives 2014/24/EU (22) and 2014/25/EU (23) of the European Parliament and of the Council on public procurement, defining procedures for the procurement of public contracts and design contests for certain supplies (products), services and works, establish that, for all procurement which is intended for use by natural persons, whether general public or staff of the contracting authority or entity, the technical specifications are, except in duly justified cases, to be drawn up so as to take into account accessibility criteria for persons with disabilities or design for all users. Furthermore, those Directives require that, where mandatory accessibility requirements are adopted by a legal act of the Union, technical specifications are, as far as accessibility for persons with disabilities or design for all users are concerned, to be established by reference thereto. This Directive should establish mandatory accessibility requirements for products and services covered by it. For products and services not falling under the scope of this Directive, the accessibility requirements of this Directive are not binding. However, the use of those accessibility requirements to fulfil the relevant obligations set out in Union acts other than this Directive would facilitate the implementation of accessibility and contribute to the legal certainty and to the approximation of accessibility requirements across the Union. Authorities should not be prevented from establishing accessibility requirements that go beyond the accessibility requirements set out in Annex I to this Directive. (91) This Directive should not change the compulsory or voluntary nature of the provisions related to accessibility in other Union acts. (92) This Directive should only apply to procurement procedures for which the call for competition has been sent or, in cases where a call for competition is not foreseen, where the contracting authority or contracting entity has commenced the procurement procedure after the date of application of this Directive. (93) In order to ensure the proper application of this Directive, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of: further specifying the accessibility requirements that, by their very nature, cannot produce their intended effect unless they are further specified in binding legal acts of the Union; changing the period during which economic operators are to be able to identify any other economic operator who has supplied them with a product or to whom they have supplied a product; and further specifying the relevant criteria that are to be taken into account by the economic operator for the assessment of whether compliance with the accessibility requirements would impose a disproportionate burden. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (24). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (94) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission with regard to the technical specifications. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (25). (95) Member States should ensure that adequate and effective means exist to ensure compliance with this Directive and should therefore establish appropriate control mechanisms, such as a posteriori control by the market surveillance authorities, in order to verify that the exemption from the accessibility requirements application is justified. When dealing with complaints related to accessibility, Member States should comply with the general principle of good administration, and in particular with the obligation of officials to ensure that a decision on each complaint is taken within a reasonable time-limit. (96) In order to facilitate the uniform implementation of this Directive, the Commission should establish a working group consisting of relevant authorities and stakeholders to facilitate exchange of information and of best practices and to provide advice. Cooperation should be fostered between authorities and relevant stakeholders, including persons with disabilities and organisations that represent them, inter alia, to improve coherence in the application of provisions of this Directive concerning accessibility requirements and to monitor implementation of its provisions on fundamental alteration and disproportionate burden. (97) Given the existing legal framework concerning remedies in the areas covered by Directives 2014/24/EU and 2014/25/EU, the provisions of this Directive relating to enforcement and penalties should not be applicable to the procurement procedures subject to the obligations imposed by this Directive. Such exclusion is without prejudice to the obligations of Member States under the Treaties to take all measures necessary to guarantee the application and effectiveness of Union law. (98) Penalties should be adequate in relation to the character of the infringements and to the circumstances so as not to serve as an alternative to the fulfilment by economic operators of their obligations to make their products or services accessible. (99) Member States should ensure that, in accordance with existing Union law, alternative dispute resolutions mechanisms are in place that allow the resolution of any alleged non-compliance with this Directive prior to an action being brought before courts or competent administrative bodies. (100) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (26), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a Directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified. (101) In order to allow service providers sufficient time to adapt to the requirements of this Directive, it is necessary to provide for a transitional period of five years after the date of application of this Directive, during which products used for the provision of a service which were placed on the market before that date do not need to comply with the accessibility requirements of this Directive unless they are replaced by the service providers during the transitional period. Given the cost and long life-cycle of self-service terminals, it is appropriate to provide that, when such terminals are used in the provision of services, they may continue to be used until the end of their economic life, as long as they are not replaced during that period, but not for longer than 20 years. (102) The accessibility requirements of this Directive should apply to products placed on the market and services provided after the date of application of the national measures transposing this Directive, including used and second-hand products imported from a third country and placed on the market after that date. (103) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union (‘the Charter’). In particular, this Directive seeks to ensure full respect for the rights of persons with disabilities to benefit from measures designed to ensure their independence, social and occupational integration and participation in the life of the community and to promote the application of Articles 21, 25 and 26 of the Charter. (104) Since the objective of this Directive, namely, the elimination of barriers to the free movement of certain accessible products and services, in order to contribute to the proper functioning of the internal market, cannot be sufficiently achieved by the Member States because it requires the harmonisation of different rules currently existing in their respective legal systems, but can rather, by defining common accessibility requirements and rules for the functioning of the internal market, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I General provisions Article 1 Subject matter The purpose of this Directive is to contribute to the proper functioning of the internal market by approximating the laws, regulations and administrative provisions of the Member States as regards accessibility requirements for certain products and services by, in particular, eliminating and preventing barriers to the free movement of products and services covered by this Directive arising from divergent accessibility requirements in the Member States. Article 2 Scope 1. This Directive applies to the following products placed on the market after 28 June 2025: (a) consumer general purpose computer hardware systems and operating systems for those hardware systems; (b) the following self-service terminals: (i) payment terminals; (ii) the following self-service terminals dedicated to the provision of services covered by this Directive: — automated teller machines; — ticketing machines; — check-in machines; — interactive self-service terminals providing information, excluding terminals installed as integrated parts of vehicles, aircrafts, ships or rolling stock; (c) consumer terminal equipment with interactive computing capability, used for electronic communications services; (d) consumer terminal equipment with interactive computing capability, used for accessing audiovisual media services; and (e) e-readers. 2. Without prejudice to Article 32, this Directive applies to the following services provided to consumers after 28 June 2025: (a) electronic communications services with the exception of transmission services used for the provision of machine-to-machine services; (b) services providing access to audiovisual media services; (c) the following elements of air, bus, rail and waterborne passenger transport services, except for urban, suburban and regional transport services for which only the elements under point (v) apply: (i) websites; (ii) mobile device-based services including mobile applications; (iii) electronic tickets and electronic ticketing services; (iv) delivery of transport service information, including real-time travel information; this shall, with regard to information screens, be limited to interactive screens located within the territory of the Union; and (v) interactive self-service terminals located within the territory of the Union, except those installed as integrated parts of vehicles, aircrafts, ships and rolling stock used in the provision of any part of such passenger transport services; (d) consumer banking services; (e) e-books and dedicated software; and (f) e-commerce services. 3. This Directive applies to answering emergency communications to the single European emergency number ‘112’. 4. This Directive does not apply to the following content of websites and mobile applications: (a) pre-recorded time-based media published before 28 June 2025; (b) office file formats published before 28 June 2025; (c) online maps and mapping services, if essential information is provided in an accessible digital manner for maps intended for navigational use; (d) third-party content that is neither funded, developed by, or under the control of, the economic operator concerned; (e) content of websites and mobile applications qualifying as archives, meaning that they only contain content that is not updated or edited after 28 June 2025. 5. This Directive shall be without prejudice to Directive (EU) 2017/1564 and Regulation (EU) 2017/1563. Article 3 Definitions For the purposes of this Directive, the following definitions apply: (1) ‘persons with disabilities’ means persons who have long-term physical, mental, intellectual or sensory impairments which in interaction with various barriers may hinder their full and effective participation in society on an equal basis with others; (2) ‘product’ means a substance, preparation, or good produced through a manufacturing process, other than food, feed, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction; (3) ‘service’ means a service as defined in point 1 of Article 4 of Directive 2006/123/EC of the European Parliament and of the Council (27); (4) ‘service provider’ means any natural or legal person who provides a service on the Union market or makes offers to provide such a service to consumers in the Union; (5) ‘audiovisual media services’ means services as defined in point (a) of Article 1(1) of Directive 2010/13/EU; (6) ‘services providing access to audiovisual media services’ means services transmitted by electronic communications networks which are used to identify, select, receive information on, and view audiovisual media services and any provided features, such as subtitles for the deaf and hard of hearing, audio description, spoken subtitles and sign language interpretation, which result from the implementation of measures to make services accessible as referred to in Article 7 of Directive 2010/13/EU; and includes electronic programme guides (EPGs); (7) ‘consumer terminal equipment with interactive computing capability, used for accessing audiovisual media services’ means any equipment the main purpose of which is to provide access to audiovisual media services; (8) ‘electronic communications service’ means electronic communications service as defined in point 4 of Article 2 of Directive (EU) 2018/1972; (9) ‘total conversation service’ means total conversation service as defined in point 35 of Article 2 of Directive (EU) 2018/1972; (10) ‘public safety answering point’ or ‘PSAP’ means public safety answering point or PSAP as defined in point 36 of Article 2 of Directive (EU) 2018/1972; (11) ‘most appropriate PSAP’ means most appropriate PSAP as defined in point 37 of Article 2 of Directive (EU) 2018/1972; (12) ‘emergency communication’ means emergency communication as defined in point 38 of Article 2 of Directive (EU) 2018/1972; (13) ‘emergency service’ means emergency service as defined in point 39 of Article 2 of Directive (EU) 2018/1972; (14) ‘real time text’ means a form of text conversation in point to point situations or in multipoint conferencing where the text being entered is sent in such a way that the communication is perceived by the user as being continuous on a character-by-character basis; (15) ‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (16) ‘placing on the market’ means the first making available of a product on the Union market; (17) ‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark; (18) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks; (19) ‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market; (20) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market; (21) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor or the service provider; (22) ‘consumer’ means any natural person who purchases the relevant product or is a recipient of the relevant service for purposes which are outside his trade, business, craft or profession; (23) ‘microenterprise’ means an enterprise which employs fewer than 10 persons and which has an annual turnover not exceeding EUR 2 million or an annual balance sheet total not exceeding EUR 2 million; (24) ‘small and medium-sized enterprises’ or ‘SMEs’ means enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, or an annual balance sheet total not exceeding EUR 43 million, but excludes microenterprises; (25) ‘harmonised standard’ means a harmonised standard as defined in point 1(c) of Article 2 of Regulation (EU) No 1025/2012; (26) ‘technical specification’ means a technical specification as defined in point 4 of Article 2 of Regulation (EU) No 1025/2012 that provides a means to comply with the accessibility requirements applicable to a product or service; (27) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market; (28) ‘consumer banking services’ means the provision to consumers of the following banking and financial services: (a) credit agreements covered by Directive 2008/48/EC of the European Parliament and of the Council (28) or Directive 2014/17/EU of the European Parliament and of the Council (29); (b) services as defined in points 1, 2, 4 and 5 in Section A and points 1, 2, 4 and 5 in Section B of Annex I to Directive 2014/65/EU of the European Parliament and of the Council (30); (c) payment services as defined in point 3 of Article 4 of Directive (EU) 2015/2366 of the European Parliament and of the Council (31); (d) services linked to the payment account as defined in point 6 of Article 2 of Directive 2014/92/EU of the European Parliament and of the Council (32); and (e) electronic money as defined in point 2 of Article 2 of Directive 2009/110/EC of the European Parliament and of the Council (33); (29) ‘payment terminal’ means a device the main purpose of which is to allow payments to be made by using payment instruments as defined in point 14 of Article 4 of Directive (EU) 2015/2366 at a physical point of sale but not in a virtual environment; (30) ‘e-commerce services’ means services provided at a distance, through websites and mobile device-based services by electronic means and at the individual request of a consumer with a view to concluding a consumer contract; (31) ‘air passenger transport services’ means commercial passenger air services, as defined in point (l) of Article 2 of Regulation (EC) No 1107/2006, on departure from, on transit through, or on arrival at an airport, when the airport is situated in the territory of a Member State, including flights departing from an airport situated in a third country to an airport situated in the territory of a Member State where the services are operated by Union air carriers; (32) ‘bus passenger transport services’ means services covered by Article 2(1) and (2) of Regulation (EU) No 181/2011; (33) ‘rail passenger transport services’ means all rail passenger services as referred to in Article 2(1) of Regulation (EC) No 1371/2007, with the exception of services referred to in Article 2(2) thereof; (34) ‘waterborne passenger transport services’ means passenger services covered by Article 2(1) of Regulation (EU) No 1177/2010, with the exception of services referred to in Article 2(2) of that Regulation; (35) ‘urban and suburban transport services’ means urban and suburban services as defined in point 6 of Article 3 of Directive 2012/34/EU of the European Parliament and of the Council (34); but for the purposes of this Directive, it includes only the following modes of transport: rail, bus and coach, metro, tram and trolley bus; (36) ‘regional transport services’ means regional services as defined in point 7 of Article 3 of Directive 2012/34/EU; but for the purposes of this Directive, it includes only the following modes of transport: rail, bus and coach, metro, tram and trolley bus; (37) ‘assistive technology’ means any item, piece of equipment, service or product system including software that is used to increase, maintain, substitute or improve functional capabilities of persons with disabilities or for, alleviation and compensation of impairments, activity limitations or participation restrictions; (38) ‘operating system’ means software, which, inter alia, handles the interface to peripheral hardware, schedules tasks, allocates storage, and presents a default interface to the user when no application program is running including a graphical user interface, regardless of whether such software is an integral part of consumer general purpose computer hardware, or constitutes free-standing software intended to be run on consumer general purpose computer hardware, but excluding an operating system loader, basic input/output system, or other firmware required at boot time or when installing the operating system; (39) ‘consumer general purpose computer hardware system’ means the combination of hardware which forms a complete computer, characterised by its multipurpose nature, its ability to perform, with the appropriate software, most common computing tasks requested by consumers and intended to be operated by consumers, including personal computers, in particular desktops, notebooks, smartphones and tablets; (40) ‘interactive computing capability’ means functionality supporting human-device interaction allowing for processing and transmission of data, voice or video or any combination thereof; (41) ‘e-book and dedicated software’ means a service, consisting of the provision of digital files that convey an electronic version of a book, that can be accessed, navigated, read and used and the software including mobile device-based services including mobile applications dedicated to the accessing, navigation, reading and use of those digital files, and it excludes software covered under the definition in point (42); (42) ‘e-reader’ means dedicated equipment, including both hardware and software, used to access, navigate, read and use e-book files; (43) ‘electronic tickets’ means any system in which an entitlement to travel, in the form of single or multiple travel tickets, travel subscriptions or travel credit, is stored electronically on a physical transport pass or other device, instead of being printed on a paper ticket; (44) ‘electronic ticketing services’ means any system in which passenger transport tickets are purchased including online using a device with interactive computing capability, and delivered to the purchaser in electronic form, to enable them to be printed in paper form or displayed using a mobile device with interactive computing capability when travelling. CHAPTER II Accessibility requirements and free movement Article 4 Accessibility requirements 1. Member States shall ensure, in accordance with paragraphs 2, 3 and 5 of this Article and subject to Article 14, that economic operators only place on the market products and only provide services that comply with the accessibility requirements set out in Annex I. 2. All products shall comply with the accessibility requirements set out in Section I of Annex I. All products, except for self-service terminals, shall comply with the accessibility requirements set out in Section II of Annex I. 3. Without prejudice to paragraph 5 of this Article, all services, except for urban and suburban transport services and regional transport services, shall comply with the accessibility requirements set out in Section III of Annex I. Without prejudice to paragraph 5 of this Article, all services shall comply with the accessibility requirements set out in Section IV of Annex I. 4. Member States may decide, in the light of national conditions, that the built environment used by clients of services covered by this Directive shall comply with the accessibility requirements set out in Annex III, in order to maximise their use by persons with disabilities. 5. Microenterprises providing services shall be exempt from complying with the accessibility requirements referred to in paragraph 3 of this Article and any obligations relating to the compliance with those requirements. 6. Member States shall provide guidelines and tools to microenterprises to facilitate the application of the national measures transposing this Directive. Member States shall develop those tools in consultation with relevant stakeholders. 7. Member States may inform economic operators of the indicative examples, contained in Annex II, of possible solutions that contribute to meeting the accessibility requirements in Annex I. 8. Member States shall ensure that the answering of emergency communications to the single European emergency number ‘112’ by the most appropriate PSAP, shall comply with the specific accessibility requirements set out in Section V of Annex I in the manner best suited to the national organisation of emergency systems. 9. The Commission is empowered to adopt delegated acts in accordance with Article 26 to supplement Annex I by further specifying the accessibility requirements that, by their very nature, cannot produce their intended effect unless they are further specified in binding legal acts of the Union, such as requirements related to interoperability. Article 5 Existing Union law in the field of passenger transport Services complying with the requirements on the provision of accessible information and of information on accessibility laid down in Regulations (EC) No 261/2004, (EC) No 1107/2006, (EC) No 1371/2007, (EU) No 1177/2010, and (EU) No 181/2011 and relevant acts adopted on the basis of Directive 2008/57/EC shall be deemed to comply with the corresponding requirements of this Directive. Where this Directive provides for requirements additional to those provided in those Regulations and those acts, the additional requirements shall apply in full. Article 6 Free movement Member States shall not impede, for reasons related to accessibility requirements, the making available on the market in their territory of products or the provision of services in their territory that comply with this Directive. CHAPTER III Obligations of economic operators dealing with products Article 7 Obligations of manufacturers 1. When placing their products on the market, manufacturers shall ensure that the products have been designed and manufactured in accordance with the applicable accessibility requirements of this Directive. 2. Manufacturers shall draw up the technical documentation in accordance with Annex IV and carry out the conformity assessment procedure set out in that Annex or have it carried out. Where compliance of a product with the applicable accessibility requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking. 3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for five years after the product has been placed on the market. 4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive. Changes in product design or characteristics and changes in the harmonised standards, or in technical specifications, by reference to which conformity of a product is declared shall be adequately taken into account. 5. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product. 6. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities. 7. Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and information, as well as any labelling, shall be clear, understandable and intelligible. 8. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that product into conformity, or, if appropriate, to withdraw it. Furthermore, where the product does not comply with the accessibility requirements of this Directive, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. In such cases, manufacturers shall keep a register of products which do not comply with applicable accessibility requirements and of the related complaints. 9. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the non-compliance with the applicable accessibility requirements of products which they have placed on the market, in particular bringing the products into compliance with the applicable accessibility requirements. Article 8 Authorised representatives 1. A manufacturer may, by a written mandate, appoint an authorised representative. The obligations laid down in Article 7(1) and the drawing up of technical documentation shall not form part of the authorised representative’s mandate. 2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following: (a) keep the EU declaration of conformity and the technical documentation at the disposal of market surveillance authorities for five years; (b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product; (c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the non-compliance with the applicable accessibility requirements of products covered by their mandate. Article 9 Obligations of importers 1. Importers shall place only compliant products on the market. 2. Before placing a product on the market, importers shall ensure that the conformity assessment procedure set out in Annex IV has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation required by that Annex, that the product bears the CE marking and is accompanied by the required documents and that the manufacturer has complied with the requirements set out in Article 7(5) and (6). 3. Where an importer considers or has reason to believe that a product is not in conformity with the applicable accessibility requirements of this Directive, the importer shall not place the product on the market until it has been brought into conformity. Furthermore, where the product does not comply with the applicable accessibility requirements, the importer shall inform the manufacturer and the market surveillance authorities to that effect. 4. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The contact details shall be in a language easily understood by end-users and market surveillance authorities. 5. Importers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. 6. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the applicable accessibility requirements. 7. Importers shall, for a period of five years keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and shall ensure that the technical documentation can be made available to those authorities upon request. 8. Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that product into conformity, or, if appropriate, to withdraw it. Furthermore, where the product does not comply with the applicable accessibility requirements, importers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. In such cases, importers shall keep a register of products which do not comply with applicable accessibility requirements, and of the related complaints. 9. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the non-compliance with the applicable accessibility requirements of products which they have placed on the market. Article 10 Obligations of distributors 1. When making a product available on the market distributors shall act with due care in relation to the requirements of this Directive. 2. Before making a product available on the market distributors shall verify that the product bears the CE marking, that it is accompanied by the required documents and by instructions and safety information in a language which can be easily understood by consumers and other end-users in the Member State in which the product is to be made available on the market and that the manufacturer and the importer have complied with the requirements set out in Article 7(5) and (6) and Article 9(4) respectively. 3. Where a distributor considers or has reason to believe that a product is not in conformity with the applicable accessibility requirements of this Directive, the distributor shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product does not comply with the applicable accessibility requirements, the distributor shall inform the manufacturer or the importer and the market surveillance authorities to that effect. 4. Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the applicable accessibility requirements. 5. Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with this Directive shall make sure that the corrective measures necessary to bring that product into conformity, or, if appropriate, to withdraw it, are taken. Furthermore, where the product, does not comply with the applicable accessibility requirements, distributors shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 6. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product. They shall cooperate with that authority, at its request, on any action taken to eliminate the non-compliance with the applicable accessibility requirements of products which they have made available on the market. Article 11 Cases in which obligations of manufacturers apply to importers and distributors An importer or distributor shall be considered a manufacturer for the purposes of this Directive and shall be subject to the obligations of the manufacturer under Article 7, where it places a product on the market under its name or trademark or modifies a product already placed on the market in such a way that compliance with the requirements of this Directive may be affected. Article 12 Identification of economic operators dealing with products 1. Economic operators referred to in Articles 7 to 10 shall, upon request, identify to the market surveillance authorities, the following: (a) any other economic operator who has supplied them with a product; (b) any other economic operator to whom they have supplied a product. 2. Economic operators referred to in Articles 7 to 10 shall be able to present the information referred to in paragraph 1 of this Article for a period of five years after they have been supplied with the product and for a period of five years after they have supplied the product. 3. The Commission is empowered to adopt delegated acts in accordance with Article 26 to amend this Directive in order to change the period referred to in paragraph 2 of this Article for specific products. That amended period shall be longer than five years, and shall be in proportion to the economically useful life of the product concerned. CHAPTER IV Obligations of service providers Article 13 Obligations of service providers 1. Service providers shall ensure that they design and provide services in accordance with the accessibility requirements of this Directive. 2. Service providers shall prepare the necessary information in accordance with Annex V and shall explain how the services meet the applicable accessibility requirements. The information shall be made available to the public in written and oral format, including in a manner which is accessible to persons with disabilities. Service providers shall keep that information for as long as the service is in operation. 3. Without prejudice to Article 32, service providers shall ensure that procedures are in place so that the provision of services remains in conformity with the applicable accessibility requirements. Changes in the characteristics of the provision of the service, changes in applicable accessibility requirements and changes in the harmonised standards or in technical specifications by reference to which a service is declared to meet the accessibility requirements shall be adequately taken into account by the service providers. 4. In the case of non-conformity, service providers shall take the corrective measures necessary to bring the service into conformity with the applicable accessibility requirements. Furthermore, where the service is not compliant with applicable accessibility requirements, service providers shall immediately inform the competent national authorities of the Member States in which the service is provided, to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. 5. Service providers shall, further to a reasoned request from a competent authority, provide it with all information necessary to demonstrate the conformity of the service with the applicable accessibility requirements. They shall cooperate with that authority, at the request of that authority, on any action taken to bring the service into compliance with those requirements. CHAPTER V Fundamental alteration of products or services and disproportionate burden to economic operators Article 14 Fundamental alteration and disproportionate burden 1. The accessibility requirements referred to in Article 4 shall apply only to the extent that compliance: (a) does not require a significant change in a product or service that results in the fundamental alteration of its basic nature; and (b) does not result in the imposition of a disproportionate burden on the economic operators concerned. 2. Economic operators shall carry out an assessment of whether compliance with the accessibility requirements referred to in Article 4 would introduce a fundamental alteration or, based on the relevant criteria set out in Annex VI, impose a disproportionate burden, as provided for in paragraph 1 of this Article. 3. Economic operators shall document the assessment referred to in paragraph 2. Economic operators shall keep all relevant results for a period of five years to be calculated from the last making available of a product on the market or after a service was last provided, as applicable. Upon a request from the market surveillance authorities or from the authorities responsible for checking compliance of services, as applicable, the economic operators shall provide the authorities with a copy of the assessment referred to in paragraph 2. 4. By way of derogation from paragraph 3, microenterprises dealing with products shall be exempted from the requirement to document their assessment. However, if a market surveillance authority so requests, microenterprises dealing with products and which have chosen to rely on paragraph 1 shall provide the authority with the facts relevant to the assessment referred to in paragraph 2. 5. Service providers relying on point (b) of paragraph 1 shall, with regard to each category or type of service, renew their assessment of whether the burden is disproportionate: (a) when the service offered is altered; or (b) when requested to do so by the authorities responsible for checking compliance of services; and (c) in any event, at least every five years. 6. Where economic operators receive funding from other sources than the economic operator’s own resources, whether public or private, that is provided for the purpose of improving accessibility, they shall not be entitled to rely on point (b) of paragraph 1. 7. The Commission is empowered to adopt delegated acts in accordance with Article 26 to supplement Annex VI by further specifying the relevant criteria that are to be taken into account by the economic operator for the assessment referred to in paragraph 2 of this Article. When further specifying those criteria, the Commission shall take into account not only the potential benefits for persons with disabilities, but also those for persons with functional limitations. When necessary, the Commission shall adopt the first such delegated act by 28 June 2020. Such act shall start to apply, at the earliest, in 28 June 2025. 8. Where economic operators rely on paragraph 1 for a specific product or service they shall send information to that effect to the relevant market surveillance authorities, or authorities responsible for checking the compliance of services, of the Member State where the specific product is placed on the market or the specific service is provided. The first subparagraph shall not apply to microenterprises. CHAPTER VI Harmonised standards and technical specifications of products and services Article 15 Presumption of conformity 1. Products and services which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the accessibility requirements of this Directive in so far as those standards or parts thereof cover those requirements. 2. The Commission shall, in accordance with Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards for the product accessibility requirements set out in Annex I. The Commission shall submit the first such draft request to the relevant committee by 28 June 2021. 3. The Commission may adopt implementing acts establishing technical specifications that meet the accessibility requirements of this Directive where the following conditions have been fulfilled: (a) no reference to harmonised standards is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012; and (b) either: (i) the Commission has requested one or more European standardisation organisations to draft a harmonised standard and there are undue delays in the standardisation procedure or the request has not been accepted by any European standardisation organisations; or (ii) the Commission can demonstrate that a technical specification respects the requirements laid down in Annex II of Regulation (EU) No 1025/2012, except for the requirement that the technical specifications should have been developed by a non-profit making organisation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2). 4. Products and services which are in conformity with the technical specifications or parts thereof shall be presumed to be in conformity with the accessibility requirements of this Directive in so far as those technical specifications or parts thereof cover those requirements. CHAPTER VII Conformity of products and CE marking Article 16 EU declaration of conformity of products 1. The EU declaration of conformity shall state that the fulfilment of the applicable accessibility requirements has been demonstrated. Where as an exception, Article 14 has been used, the EU declaration of conformity shall state which accessibility requirements are subject to that exception. 2. The EU declaration of conformity shall have the model structure set out in Annex III to Decision No 768/2008/EC. It shall contain the elements specified in Annex IV to this Directive and shall be continuously updated. The requirements concerning the technical documentation shall avoid imposing any undue burden for microenterprises and SMEs. It shall be translated into the language or languages required by the Member State in which the product is placed or made available on the market. 3. Where a product is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the acts concerned including the publication references. 4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the product with the requirements of this Directive. Article 17 General principles of the CE marking of products The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. Article 18 Rules and conditions for affixing the CE marking 1. The CE marking shall be affixed visibly, legibly and indelibly to the product or to its data plate. Where that is not possible, or not warranted, on account of the nature of the product, it shall be affixed to the packaging and to the accompanying documents. 2. The CE marking shall be affixed before the product is placed on the market. 3. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. CHAPTER VIII Market surveillance of products and Union safeguard procedure Article 19 Market surveillance of products 1. Article 15(3), Articles 16 to 19, Article 21, Articles 23 to 28 and Article 29(2) and (3) of Regulation (EC) No 765/2008 shall apply to products. 2. When carrying out market surveillance of products, the relevant market surveillance authorities shall, when the economic operator has relied on Article 14 of this Directive: (a) check that the assessment referred to in Article 14 has been conducted by the economic operator; (b) review that assessment and its results, including the correct use of the criteria set out in Annex VI; and (c) check compliance with the applicable accessibility requirements. 3. Member States shall ensure that information held by market surveillance authorities concerning the compliance of economic operators with the applicable accessibility requirements of this Directive and the assessment provided for in Article 14, is made available to consumers upon request and in an accessible format, except where that information cannot be provided for reasons of confidentiality as provided for in Article 19(5) of Regulation (EC) No 765/2008. Article 20 Procedure at national level for dealing with products not complying with the applicable accessibility requirements 1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a product covered by this Directive does not comply with the applicable accessibility requirements, they shall carry out an evaluation in relation to the product concerned covering all requirements laid down in this Directive. The relevant economic operators shall fully cooperate with the market surveillance authorities for that purpose. Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the product does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the product into compliance with those requirements within a reasonable period, commensurate with the nature of the non-compliance, as they may prescribe. Market surveillance authorities shall require the relevant economic operator to withdraw the product from the market, within an additional reasonable period, only if the relevant economic operator has failed to take adequate corrective action within the period referred to in the second subparagraph. Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second and third subparagraphs of this paragraph. 2. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take. 3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union. 4. Where the relevant economic operator does not take adequate corrective action within the period referred to in the third subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the product’s being made available on their national markets or to withdraw the product from that market. The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures. 5. The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the non-compliance alleged and the accessibility requirements with which the product does not comply, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either: (a) the failure of the product to meet the applicable accessibility requirements; or (b) the shortcomings in the harmonised standards or in the technical specifications referred to in Article 15 conferring a presumption of conformity. 6. Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the product concerned, and, in the event of disagreement with the notified national measure, of their objections. 7. Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified. 8. Member States shall ensure that appropriate restrictive measures, such as withdrawal of the product from their market, are taken in respect of the product concerned without delay. Article 21 Union safeguard procedure 1. Where, on completion of the procedure set out in Article 20(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission has reasonable evidence to suggest that a national measure is contrary to Union law, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not. The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators. 2. Where the national measure referred to in paragraph 1 is considered justified, all Member States shall take the measures necessary to ensure that the non-compliant product is withdrawn from their market, and shall inform the Commission accordingly. Where the national measure is considered unjustified, the Member State concerned shall withdraw the measure. 3. Where the national measure referred to in paragraph 1 of this Article is considered justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards referred to in point (b) of Article 20(5), the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012. 4. Where the national measure referred to in paragraph 1 of this Article is considered justified and the non-compliance of the product is attributed to shortcomings in the technical specifications referred to in point (b) of Article 20(5), the Commission shall, without delay, adopt implementing acts amending or repealing the technical specification concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2). Article 22 Formal non-compliance 1. Without prejudice to Article 20, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned: (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 18 of this Directive; (b) the CE marking has not been affixed; (c) the EU declaration of conformity has not been drawn up; (d) the EU declaration of conformity has not been drawn up correctly; (e) technical documentation is either not available or not complete; (f) the information referred to in Article 7(6) or Article 9(4) is absent, false or incomplete; (g) any other administrative requirement provided for in Article 7 or Article 9 is not fulfilled. 2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is withdrawn from the market. CHAPTER IX Compliance of services Article 23 Compliance of services 1. Member States shall establish, implement and periodically update adequate procedures in order to: (a) check the compliance of services with the requirements of this Directive, including the assessment referred to in Article 14 for which Article 19(2) shall apply mutatis mutandis; (b) follow up complaints or reports on issues relating to non-compliance of services with the accessibility requirements of this Directive; (c) verify that the economic operator has taken the necessary corrective action. 2. Member States shall designate the authorities responsible for the implementation of the procedures referred to in paragraph 1 with respect to the compliance of services. Member States shall ensure that the public is informed of the existence, responsibilities, identity, work and decisions of the authorities referred to in the first subparagraph. Those authorities shall make that information available in accessible formats upon request. CHAPTER X Accessibility requirements in other Union acts Article 24 Accessibility under other Union acts 1. As regards the products and services referred to in Article 2 of this Directive, the accessibility requirements set out in Annex I thereto shall constitute mandatory accessibility requirements within the meaning of Article 42(1) of Directive 2014/24/EU and of Article 60(1) of Directive 2014/25/EU. 2. Any product or service, the features, elements or functions of which comply with the accessibility requirements set out in Annex I to this Directive in accordance with Section VI thereof shall be presumed to fulfil the relevant obligations set out in Union acts other than this Directive, as regards accessibility, for those features, elements or functions, unless otherwise provided in those other acts. Article 25 Harmonised standards and technical specifications for other Union acts Conformity with harmonised standards and technical specifications or parts thereof which are adopted in accordance with Article 15, shall create a presumption of compliance with Article 24 in so far as those standards and technical specifications or parts thereof meet the accessibility requirements of this Directive. CHAPTER XI Delegated acts, implementing powers and final provisions Article 26 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 4(9) shall be conferred on the Commission for an indeterminate period of time from 27 June 2019. The power to adopt delegated acts referred to in Article 12(3) and Article 14(7) shall be conferred on the Commission for a period of five years from 27 June 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 4(9), Article 12(3) and Article 14(7) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 4(9), Article 12(3) and Article 14(7) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 27 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 28 Working Group The Commission shall establish a working group consisting of representatives of market surveillance authorities, authorities responsible for compliance of services and relevant stakeholders, including representatives of persons with disabilities organisations. The working group shall: (a) facilitate the exchange of information and best practices among the authorities and relevant stakeholders; (b) foster cooperation between authorities and relevant stakeholders on matters relating to the implementation of this Directive to improve coherence in the application of the accessibility requirements of this Directive and to monitor closely the implementation of Article 14; and (c) provide advice, in particular to the Commission, notably on the implementation of Article 4 and Article 14. Article 29 Enforcement 1. Member States shall ensure that adequate and effective means exist to ensure compliance with this Directive. 2. The means referred to in paragraph 1 shall include: (a) provisions whereby a consumer may take action under national law before the courts or before the competent administrative bodies to ensure that the national provisions transposing this Directive are complied with; (b) provisions whereby public bodies or private associations, organisations or other legal entities which have a legitimate interest, in ensuring that this Directive is complied with, may engage under national law before the courts or before the competent administrative bodies either on behalf or in support of the complainant, with his or her approval, in any judicial or administrative procedure provided for the enforcement of obligations under this Directive. 3. This Article shall not apply to procurement procedures which are subject to Directive 2014/24/EU or Directive 2014/25/EU. Article 30 Penalties 1. Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. 2. The penalties provided for shall be effective, proportionate and dissuasive. Those penalties shall also be accompanied by effective remedial action in case of non-compliance of the economic operator. 3. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them. 4. Penalties shall take into account the extent of the non-compliance, including its seriousness, and the number of units of non-complying products or services concerned, as well as the number of persons affected. 5. This Article shall not apply to procurement procedures which are subject to Directive 2014/24/EU or Directive 2014/25/EU. Article 31 Transposition 1. Member States shall adopt and publish, by 28 June 2022, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately communicate the text of those measures to the Commission. 2. They shall apply those measures from 28 June 2025. 3. By way of derogation from paragraph 2 of this Article, Member States may decide to apply the measures regarding the obligations set out in Article 4(8) at the latest from 28 June 2027. 4. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. 5. Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive. 6. Member States using the possibility provided for in Article 4(4) shall communicate to the Commission the text of the main measures of national law which they adopt to that end and shall report to the Commission on the progress made in their implementation. Article 32 Transitional measures 1. Without prejudice to paragraph 2 of this Article, Member States shall provide for a transitional period ending on 28 June 2030 during which service providers may continue to provide their services using products which were lawfully used by them to provide similar services before that date. Service contracts agreed before 28 June 2025 may continue without alteration until they expire, but no longer than five years from that date. 2. Member States may provide that self-service terminals lawfully used by service providers for the provision of services before 28 June 2025 may continue to be used in the provision of similar services until the end of their economically useful life, but no longer than 20 years after their entry into use. Article 33 Report and review 1. By 28 June 2030, and every five years thereafter, the Commission shall submit to the European Parliament, to the Council, to the European Economic and Social Committee and to the Committee of the Regions a report on the application of this Directive. 2. The reports shall, inter alia, address in the light of social, economic and technological developments the evolution of the accessibility of products and services, possible technology lock in or barriers to innovation and the impact of this Directive on economic operators and on persons with disabilities. The reports shall also assess whether the application of Article 4(4) has contributed to approximate diverging accessibility requirements of the built environment of passenger transport services, consumer banking services and customer service centres of shops of electronic communications service providers, where possible, with a view to allowing their progressive alignment to the accessibility requirements set out in Annex III. The reports shall also assess if the application of this Directive, in particular its voluntary provisions, has contributed to approximate accessibility requirements of the built environment constituting works falling within the scope of Directive 2014/23/EU of the European Parliament and of the Council (35), Directive 2014/24/EU and Directive 2014/25/EU. The reports shall also address the effects to the functioning of the internal market of the application of Article 14 of this Directive, including, where available, on the basis of information received in accordance with Article 14(8), as well as the exemptions for microenterprises. The reports shall conclude whether this Directive has achieved its objectives and whether it would be appropriate to include new products and services, or to exclude certain products or services from the scope of this Directive and they shall identify, where possible, areas for burden reduction with a view to a possible revision of this Directive. The Commission shall, if necessary, propose appropriate measures which could include legislative measures. 3. Member States shall communicate to the Commission in due time all the information necessary for the Commission to draw up such reports. 4. The Commission’s reports shall take into account the views of the economic stakeholders and relevant non-governmental organisations, including organisations of persons with disabilities. Article 34 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 35 This Directive is addressed to the Member States. Done at Strasbourg, 17 April 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 303, 19.8.2016, p. 103. (2) Position of the European Parliament of 13 March 2019 (not yet published in the Official Journal) and decision of the Council of 9 April 2019. (3) Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251). (4) Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, p. 1). (5) Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (OJ L 321, 17.12.2018, p. 36). (6) Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (OJ L 95, 15.4.2010, p. 1). (7) Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1). (8) Regulation (EC) No 261/2004 of the European Parliament and of the Council of 11 February 2004 establishing common rules on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights, and repealing Regulation (EEC) No 295/91 (OJ L 46, 17.2.2004, p. 1). (9) Regulation (EC) No 1107/2006 of the European Parliament and of the Council of 5 July 2006 concerning the rights of disabled persons and persons with reduced mobility when travelling by air (OJ L 204, 26.7.2006, p. 1). (10) Regulation (EC) No 1371/2007 of the European Parliament and of the Council of 23 October 2007 on rail passengers’ rights and obligations (OJ L 315, 3.12.2007, p. 14). (11) Regulation (EU) No 1177/2010 of the European Parliament and of the Council of 24 November 2010 concerning the rights of passengers when travelling by sea and inland waterway and amending Regulation (EC) No 2006/2004 (OJ L 334, 17.12.2010, p. 1). (12) Regulation (EU) No 181/2011 of the European Parliament and of the Council of 16 February 2011 concerning the rights of passengers in bus and coach transport and amending Regulation (EC) No 2006/2004 (OJ L 55, 28.2.2011, p. 1). (13) Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (OJ L 191, 18.7.2008, p. 1). (14) Directive (EU) 2017/1564 of the European Parliament and of the Council of 13 September 2017 on certain permitted uses of certain works and other subject matter protected by copyright and related rights for the benefit of persons who are blind, visually impaired or otherwise print-disabled and amending Directive 2001/29/EC on the harmonisation of certain aspects of copyright and related rights in the information society (OJ L 242, 20.9.2017, p. 6). (15) Regulation (EU) 2017/1563 of the European Parliament and of the Council of 13 September 2017 on the cross-border exchange between the Union and third countries of accessible format copies of certain works and other subject matter protected by copyright and related rights for the benefit of persons who are blind, visually impaired or otherwise print-disabled (OJ L 242, 20.9.2017, p. 1). (16) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). (17) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (18) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82). (19) Regulation (EU) No 1025/2012 of 25 October 2012 of the European Parliament and of the Council on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). (20) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). (21) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (22) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). (23) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243). (24) OJ L 123, 12.5.2016, p. 1. (25) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (26) OJ C 369, 17.12.2011, p. 14. (27) Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ L 376, 27.12.2006, p. 36). (28) Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC (OJ L 133, 22.5.2008, p. 66). (29) Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (OJ L 60, 28.2.2014, p. 34). (30) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349). (31) Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (OJ L 337, 23.12.2015, p. 35). (32) Directive 2014/92/EU of the European Parliament and of the Council of 23 July 2014 on the comparability of fees related to payment accounts, payment account switching and access to payment accounts with basic features (OJ L 257, 28.8.2014, p. 214). (33) Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions amending Directives 2005/60/EC and 2006/48/EC and repealing Directive 2000/46/EC (OJ L 267, 10.10.2009, p. 7). (34) Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ L 343, 14.12.2012, p. 32). (35) Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts (OJ L 94, 28.3.2014, p. 1). ANNEX I ACCESSIBILITY REQUIREMENTS FOR PRODUCTS AND SERVICES Section I General accessibility requirements related to all products covered by this directive in accordance with Article 2(1) Products must be designed and produced in such a way as to maximise their foreseeable use by persons with disabilities and shall be accompanied where possible in or on the product by accessible information on their functioning and on their accessibility features. 1. Requirements on the provision of information: (a) the information on the use of the product provided on the product itself (labelling, instructions and warning) shall be: (i) made available via more than one sensory channel; (ii) presented in an understandable way; (iii) presented to users in ways they can perceive; (iv) presented in fonts of adequate size and suitable shape, taking into account foreseeable conditions of use, and using sufficient contrast, as well as adjustable spacing between letters, lines and paragraphs; (b) the instructions for use of a product, where not provided on the product itself but made available through the use of the product or through other means such as a website, including the accessibility functions of the product, how to activate them and their interoperability with assistive solutions shall be publicly available when the product is placed on the market and shall: (i) be made available via more than one sensory channel; (ii) be presented in an understandable way; (iii) be presented to users in ways they can perceive; (iv) be presented in fonts of adequate size and suitable shape, taking into account foreseeable conditions of use and using sufficient contrast, as well as adjustable spacing between letters, lines and paragraphs; (v) with regard to content, be made available in text formats that can be used for generating alternative assistive formats to be presented in different ways and via more than one sensory channel; (vi) be accompanied by an alternative presentation of any non-textual content; (vii) include a description of the user interface of the product (handling, control and feedback, input and output) which is provided in accordance with point 2; the description shall indicate for each of the points in point 2 whether the product provides those features; (viii) include a description of the functionality of the product which is provided by functions aiming to address the needs of persons with disabilities in accordance with point 2; the description shall indicate for each of the points in point 2 whether the product provides those features; (ix) include a description of the software and hardware interfacing of the product with assistive devices; the description shall include a list of those assistive devices which have been tested together with the product. 2. User interface and functionality design: The product, including its user interface, shall contain features, elements and functions, that allow persons with disabilities to access, perceive, operate, understand and control the product by ensuring that: (a) when the product provides for communication, including interpersonal communication, operation, information, control and orientation, it shall do so via more than one sensory channel; this shall include providing alternatives to vision, auditory, speech and tactile elements; (b) when the product uses speech it shall provide alternatives to speech and vocal input for communication, operation control and orientation; (c) when the product uses visual elements it shall provide for flexible magnification, brightness and contrast for communication, information and operation, as well as ensure interoperability with programmes and assistive devices to navigate the interface; (d) when the product uses colour to convey information, indicate an action, require a response or identify elements, it shall provide an alternative to colour; (e) when the product uses audible signals to convey information, indicate an action, require a response or identify elements, it shall provide an alternative to audible signals; (f) when the product uses visual elements it shall provide for flexible ways of improving vision clarity; (g) when the product uses audio it shall provide for user control of volume and speed, and enhanced audio features including the reduction of interfering audio signals from surrounding products and audio clarity; (h) when the product requires manual operation and control, it shall provide for sequential control and alternatives to fine motor control, avoiding the need for simultaneous controls for manipulation, and shall use tactile discernible parts; (i) the product shall avoid modes of operation requiring extensive reach and great strength; (j) the product shall avoid triggering photosensitive seizures; (k) the product shall protect the user’s privacy when he or she uses the accessibility features; (l) the product shall provide an alternative to biometrics identification and control; (m) the product shall ensure the consistency of the functionality and shall provide enough, and flexible amounts of, time for interaction; (n) the product shall provide software and hardware for interfacing with the assistive technologies; (o) the product shall comply with the following sector-specific requirements: (i) self-service terminals: — shall provide for text-to-speech technology; — shall allow for the use of personal headsets; — where a timed response is required, shall alert the user via more than one sensory channel; — shall give the possibility to extend the time given; — shall have an adequate contrast and tactilely discernible keys and controls when keys and controls are available; — shall not require an accessibility feature to be activated in order to enable a user who needs the feature to turn it on; — when the product uses audio or audible signals, it shall be compatible with assistive devices and technologies available at Union level, including hearing technologies such as hearing aids, telecoils, cochlear implants and assistive listening devices; (ii) e-readers shall provide for text-to-speech technology; (iii) consumer terminal equipment with interactive computing capability, used for the provision of electronic communications services: — shall, when such products have text capability in addition to voice, provide for the handling of real time text and support high fidelity audio; — shall, when they have video capabilities in addition to or in combination with text and voice, provide for the handling of total conversation including synchronised voice, real time text, and video with a resolution enabling sign language communication; — shall ensure effective wireless coupling to hearing technologies; — shall avoid interferences with assistive devices; (iv) consumer terminal equipment with interactive computing capability, used for accessing audio visual media services shall make available to persons with disabilities the accessibility components provided by the audiovisual media service provider, for user access, selection, control, and personalisation and for transmission to assistive devices. 3. Support services: Where available, support services (help desks, call centres, technical support, relay services and training services) shall provide information on the accessibility of the product and its compatibility with assistive technologies, in accessible modes of communication. Section II Accessibility requirements related to products in Article 2(1), except for the self-service terminals referred to in Article 2(1)(b) In addition to the requirements of Section I, the packaging and instructions of products covered by this Section shall be made accessible, in order to maximise their foreseeable use by persons with disabilities. This means that: (a) the packaging of the product including the information provided in it (e.g. about opening, closing, use, disposal), including, when provided, information about the accessibility characteristics of the product, shall be made accessible; and, when feasible, that accessible information shall be provided on the package; (b) the instructions for the installation and maintenance, storage and disposal of the product not provided on the product itself but made available through other means, such as a website, shall be publicly available when the product is placed on the market and shall comply with the following requirements: (i) be available via more than one sensory channel; (ii) be presented in an understandable way; (iii) be presented to users in ways they can perceive; (iv) be presented in fonts of adequate size and suitable shape, taking into account foreseeable conditions of use, and using sufficient contrast, as well as adjustable spacing between letters, lines and paragraphs; (v) content of instructions shall be made available in text formats that can be used for generating alternative assistive formats to be presented in different ways and via more than one sensory channel; and (vi) instructions containing any non-textual content shall be accompanied by an alternative presentation of that content. Section III General accessibility requirements related to all services covered by this Directive in accordance with Article 2(2) The provision of services in order to maximise their foreseeable use by persons with disabilities, shall be achieved by: (a) ensuring the accessibility of the products used in the provision of the service, in accordance with Section I of this Annex and, where applicable, Section II thereof; (b) providing information about the functioning of the service, and where products are used in the provision of the service, its link to these products as well as information about their accessibility characteristics and interoperability with assistive devices and facilities: (i) making the information available via more than one sensory channel; (ii) presenting the information in an understandable way; (iii) presenting the information to users in ways they can perceive; (iv) making the information content available in text formats that can be used to generate alternative assistive formats to be presented in different ways by the users and via more than one sensory channel; (v) presenting in fonts of adequate size and suitable shape, taking into account foreseeable conditions of use and using sufficient contrast, as well as adjustable spacing between letters, lines and paragraphs; (vi) supplementing any non-textual content with an alternative presentation of that content; and (vii) providing electronic information needed in the provision of the service in a consistent and adequate way by making it perceivable, operable, understandable and robust; (c) making websites, including the related online applications, and mobile device-based services, including mobile applications, accessible in a consistent and adequate way by making them perceivable, operable, understandable and robust; (d) where available, support services (help desks, call centres, technical support, relay services and training services) providing information on the accessibility of the service and its compatibility with assistive technologies, in accessible modes of communication. Section IV Additional accessibility requirements related to specific services The provision of services in order to maximise their foreseeable use by persons with disabilities, shall be achieved by including functions, practices, policies and procedures and alterations in the operation of the service targeted to address the needs of persons with disabilities and ensure interoperability with assistive technologies: (a) Electronic communications services, including emergency communications referred to in Article 109(2) of Directive (EU) 2018/1972: (i) providing real time text in addition to voice communication; (ii) providing total conversation where video is provided in addition to voice communication; (iii) ensuring that emergency communications using voice, text (including real time text) is synchronised and where video is provided is also synchronised as total conversation and is transmitted by the electronic communications service providers to the most appropriate PSAP. (b) Services providing access to audiovisual media services: (i) providing electronic programme guides (EPGs) which are perceivable, operable, understandable and robust and provide information about the availability of accessibility; (ii) ensuring that the accessibility components (access services) of the audiovisual media services such as subtitles for the deaf and hard of hearing, audio description, spoken subtitles and sign language interpretation are fully transmitted with adequate quality for accurate display, and synchronised with sound and video, while allowing for user control of their display and use. (c) Air, bus, rail and waterborne passenger transport services except for urban and suburban transport services and regional transport services: (i) ensuring the provision of information on the accessibility of vehicles, the surrounding infrastructure and the built environment and on assistance for persons with disabilities; (ii) ensuring the provision of information about smart ticketing (electronic reservation, booking of tickets, etc.), real-time travel information (timetables, information about traffic disruptions, connecting services, onwards travel with other transport modes, etc.), and additional service information (e.g. staffing of stations, lifts that are out of order or services that are temporarily unavailable). (d) Urban and suburban transport services and regional transport services: ensuring the accessibility of self-service terminals used in the provision of the service in accordance with Section I of this Annex. (e) Consumer banking services: (i) providing identification methods, electronic signatures, security, and payment services which are perceivable, operable, understandable and robust; (ii) ensuring that the information is understandable, without exceeding a level of complexity superior to level B2 (upper intermediate) of the Council of Europe’s Common European Framework of Reference for Languages. (f) E-books: (i) ensuring that, when an e-book contains audio in addition to text, it then provides synchronised text and audio; (ii) ensuring that e-book digital files do not prevent assistive technology from operating properly; (iii) ensuring access to the content, the navigation of the file content and layout including dynamic layout, the provision of the structure, flexibility and choice in the presentation of the content; (iv) allowing alternative renditions of the content and its interoperability with a variety of assistive technologies, in such a way that it is perceivable, understandable, operable and robust; (v) making them discoverable by providing information through metadata about their accessibility features; (vi) ensuring that digital rights management measures do not block accessibility features. (g) E-Commerce services: (i) providing the information concerning accessibility of the products and services being sold when this information is provided by the responsible economic operator; (ii) ensuring the accessibility of the functionality for identification, security and payment when delivered as part of a service instead of a product by making it perceivable, operable, understandable and robust; (iii) providing identification methods, electronic signatures, and payment services which are perceivable, operable, understandable and robust. Section V Specific accessibility requirements related to the answering of emergency communications to the single European emergency number ‘112’ by the most appropriate PSAP In order to maximise their foreseeable use by persons with disabilities, the answering of emergency communications to the single European emergency number ‘112’ by the most appropriate PSAP, shall be achieved by including functions, practices, policies and procedures and alterations targeted to address the needs of persons with disabilities. Emergency communications to the single European emergency number ‘112’ shall be appropriately answered, in the manner best suited to the national organisation of emergency systems, by the most appropriate PSAP using the same communication means as received, namely by using synchronised voice and text (including real time text), or, where video is provided, voice, text (including real time text) and video synchronised as total conversation. Section VI Accessibility requirements for features, elements or functions of products and services in accordance with Article 24(2) The presumption to fulfil the relevant obligations set out in other Union acts concerning features, elements or functions of products and services requires the following: 1. Products: (a) the accessibility of the information concerning the functioning and accessibility features related to products complies with the corresponding elements set out in point 1 of Section I of this Annex, namely information on the use of the product provided on the product itself and the instructions for use of a product, not provided in the product itself but made available through the use of the product or other means such as a website; (b) the accessibility of features, elements and functions of the user interface and the functionality design of products complies with the corresponding accessibility requirements of such user interface or functionality design set out in point 2 of Section I of this Annex; (c) the accessibility of the packaging, including the information provided in it and instructions for the installation and maintenance, storage and disposal of the product not provided in the product itself but made available through other means such as a website, except for self-service terminals complies with the corresponding accessibility requirements set out in Section II of this Annex. 2. Services: the accessibility of the features, elements and functions of services complies with the corresponding accessibility requirements for those features, elements and functions set out in the services-related Sections of this Annex. Section VII Functional performance criteria In order to maximise the foreseeable use by persons with disabilities, when the accessibility requirements, set out in Sections I to VI of this Annex, do not address one or more functions of the design and production of products or the provision of services those functions or means shall be accessible by complying with the related functional performance criteria. Those functional performance criteria may only be used as an alternative to one or more specific technical requirements, when these are referred to in the accessibility requirements, if and only if the application of the relevant functional performance criteria complies with the accessibility requirements and it determines that the design and production of products and the provision of services results in equivalent or increased accessibility for the foreseable use by persons with disabilities. (a) Usage without vision Where the product or service provides visual modes of operation, it shall provide at least one mode of operation that does not require vision. (b) Usage with limited vision Where the product or service provides visual modes of operation, it shall provide at least one mode of operation that enables users to operate the product with limited vision. (c) Usage without perception of colour Where the product or service provides visual modes of operation, it shall provide at least one mode of operation that does not require user perception of colour. (d) Usage without hearing Where the product or service provides auditory modes of operation, it shall provide at least one mode of operation that does not require hearing. (e) Usage with limited hearing Where the product or service provides auditory modes of operation, it shall provide at least one mode of operation with enhanced audio features that enables users with limited hearing to operate the product. (f) Usage without vocal capability Where the product or service requires vocal input from users, it shall provide at least one mode of operation that does not require vocal input. Vocal input includes any orally-generated sounds like speech, whistles or clicks. (g) Usage with limited manipulation or strength Where the product or service requires manual actions, it shall provide at least one mode of operation that enables users to make use of the product through alternative actions not requiring fine motor control and manipulation, hand strength or operation of more than one control at the same time. (h) Usage with limited reach The operational elements of products shall be within reach of all users. Where the product or service provides a manual mode of operation, it shall provide at least one mode of operation that is operable with limited reach and limited strength. (i) Minimising the risk of triggering photosensitive seizures Where the product provides visual modes of operation, it shall avoid modes of operation that trigger photosensitive seizures. (j) Usage with limited cognition The product or service shall provide at least one mode of operation incorporating features that make it simpler and easier to use. (k) Privacy Where the product or service incorporates features that are provided for accessibility, it shall provide at least one mode of operation that maintains privacy when using those features that are provided for accessibility. ANNEX II INDICATIVE NON-BINDING EXAMPLES OF POSSIBLE SOLUTIONS THAT CONTRIBUTE TO MEETING THE ACCESSIBILITY REQUIREMENTS IN ANNEX I SECTION I: EXAMPLES RELATED TO GENERAL ACCESSIBILITY REQUIREMENTS FOR ALL PRODUCTS COVERED BY THIS DIRECTIVE IN ACCORDANCE WITH ARTICLE 2(1) REQUIREMENTS IN SECTION I OF ANNEX I EXAMPLES 1. The provision of information (a) (i) Providing visual and tactile information or visual and auditory information indicating the place where to introduce a card in a self-service terminal so that blind persons and deaf persons can use the terminal. (ii) Using the same words in a consistent manner, or in a clear and logical structure, so that persons with intellectual disabilities can better understand it. (iii) Providing tactile relief format or sound in addition to a text warning so that blind persons can perceive it. (iv) Allowing that text can be read by persons who are visually impaired. (b) (i) Providing electronic files which can be read by a computer using screen readers so that blind persons can use the information. (ii) Using the same words in a consistent manner, or in a clear and logical structure, so that persons with intellectual disabilities can better understand them. (iii) Providing subtitles when video instructions are provided. (iv) Allowing that the text can be read by persons who are visually impaired. (v) Printing in Braille, so that a blind person can use them. (vi) Accompanying a diagram with a text description identifying the main elements or describing key actions. (vii) No example provided (viii) No example provided (ix) Including a socket and software in automated teller machines which will allow the plugging of a headphone which will receive the text on the screen in the form of sound. 2. User interface and functionality design (a) Providing instructions in the form of voice and text, or by incorporating tactile signs in a keypad, so that persons who are blind or hard of hearing can interact with the product. (b) Offering in a self-service terminal in addition to the spoken instructions, for example, instructions in the form of text or images so that deaf persons can also perform the action required (c) Allowing users to enlarge a text, to zoom in on a particular pictogram or to increase the contrast, so that persons who are visually impaired can perceive the information. (d) In addition of giving a choice to press the green or the red button for selecting an option, providing in written on the buttons what the options are, in order to allow person who are colour blind to make the choice. (e) When a computer gives an error signal, providing a written text or an image indicating the error, so as to allow deaf persons to apprehend that an error is occurring. (f) Allowing for additional contrast in foreground images so that persons who have low vision can see them. (g) Allowing the user of a telephone to select the volume of the sound and reduce the interference with hearing aids so that persons who are hard of hearing can use the telephone. (h) Making touch screen buttons bigger and well separated so that persons with tremor can press them. (i) Ensuring that buttons to be pressed do not require much force so that persons who have motor impairments can use them. (j) Avoiding flickering images so that persons who get seizures are not at risk. (k) Allowing the use of headphones when spoken information is provided by automated teller machines. (l) As an alternative to fingerprint recognition, allowing users who cannot use their hands to select a password for locking and unlocking a phone. (m) Ensuring that the software reacts in a predictable way when a particular action is performed and providing enough time to enter a password so that is easy to use for persons with intellectual disabilities. (n) Offering a connection with a refreshable Braille display so that blind persons can use the computer. (o) Examples of sector-specific requirements (i) No example provided (ii) No example provided (iii) First indent Providing that a mobile phone should be able to handle real time text conversations so that persons who are hard of hearing can exchange information in an interactive way. (iii) Fourth indent Allowing the simultaneous use of video to display sign language and text to write a message, so that two deaf persons can communicate with each other or with a hearing person. (iv) Ensuring that subtitles are transmitted through the set top box for their use by deaf persons. 3. Support services: No example provided SECTION II: EXAMPLES RELATED TO ACCESSIBILITY REQUIREMENTS FOR PRODUCTS IN ARTICLE 2(1), EXCEPT FOR THE SELF-SERVICE TERMINALS REFERRED TO IN ARTICLE 2(1)(b) REQUIREMENTS IN SECTION II OF ANNEX I EXAMPLES Packaging and instructions of products (a) Indicating in the packaging that the phone contains accessibility features for persons with disabilities. (b) (i) Providing electronic files which can be read by a computer using screen readers so that blind persons can use the information. (ii) Using the same words in a consistent manner, or in a clear and logical structure, so that persons with intellectual disabilities can better understand it. (iii) Providing tactile relief format or sound when a text warning is present so that blind persons receive the warning. (iv) Providing that the text can be read by persons who are visually impaired. (v) Printing in Braille, so that a blind person can read it. (vi) Supplementing a diagram with a text description identifying the main elements or describing key actions. SECTION III: EXAMPLES RELATED TO GENERAL ACCESSIBILITY REQUIREMENTS FOR ALL SERVICES COVERED BY THIS DIRECTIVE IN ACCORDANCE WITH ARTICLE 2(2) REQUIREMENTS IN SECTION III OF ANNEX I EXAMPLES The provision of services (a) No example provided (b) (i) Providing electronic files which can be read by a computer using screen readers so that blind persons can use the information. (ii) Using the same words in a consistent manner or in a clear and logical structure so that persons with intellectual disabilities can better understand it. (iii) Including subtitles when a video with instructions is provided. (iv) Providing that a blind person can use a file by printing it in Braille. (v) Providing that the text can be read by persons who are visually impaired. (vi) Supplementing a diagram with a text description identifying the main elements or describing key actions. (vii) When a service provider offers a USB-key containing information about the service, providing that information is accessible. (c) Providing text description of pictures, making all functionality available from a keyboard, giving users enough time to read, making content appear and operate in a predictable way, and providing compatibility with assistive technologies, so that persons with diverse disabilities can read and interact with a website. (d) No example provided SECTION IV: EXAMPLES RELATED TO ADDITIONAL ACCESSIBILITY REQUIREMENTS FOR SPECIFIC SERVICES REQUIREMENTS IN SECTION IV OF ANNEX I EXAMPLES Specific services (a) (i) Providing that persons who are hard of hearing could write and receive text in an interactive manner and in real time. (ii) Providing that deaf persons can use sign language to communicate among themselves. (iii) Providing that a person who has speech and hearing impairments and chooses to use a combination of text, voice and video, knows that the communication is transmitted through the network to an emergency service. (b) (i) Providing that a blind person can select programmes on the television. (ii) Supporting the possibility to select, personalise and display ‘access services’ such as subtitles for deaf persons or persons who are hard of hearing, audio description, spoken subtitles and sign language interpretation, by providing means for effective wireless coupling to hearing technologies or by providing user controls to activate ‘access services’ for audiovisual media services at the same level of prominence as the primary media controls. (c) (i) No example provided (ii) No example provided (d) No example provided (e) (i) Making the identification dialogues on a screen readable by screen readers so that blind persons can use them. (ii) No example provided (f) (i) Providing that a person with dyslexia can read and hear the text at the same time. (ii) Enabling synchronized text and audio output or by enabling a refreshable Braille transcript. (iii) Providing that a blind person can access the index or change chapters. (iv) No example provided (v) Ensuring that information on their accessibility features is available in the electronic file so that persons with disabilities can be informed. (vi) Ensuring that there is no blocking, for example that technical protection measures, rights management information or interoperability issues do not prevent the text from being read aloud by the assistive devices, so that blind users can read the book. (g) (i) Ensuring that available information on the accessibility features of a product is not deleted. (ii) Making the payment service user interface available by voice so that blind persons can make online purchases independently. (iii) Making the identification dialogues on a screen readable by screen readers so that blind persons can use them. ANNEX III ACCESSIBILITY REQUIREMENTS FOR THE PURPOSE OF ARTICLE 4(4) CONCERNING THE BUILT ENVIRONMENT WHERE THE SERVICES UNDER THE SCOPE OF THIS DIRECTIVE ARE PROVIDED In order to maximise the foreseeable use in an independent manner by persons with disabilities of the built environment in which a service is provided and which is under the responsibility of the service provider, as referred to in Article 4(4), the accessibility of areas intended for public access shall include the following aspects: (a) use of related outdoor areas and facilities; (b) approaches to buildings; (c) use of entrances; (d) use of paths in horizontal circulation; (e) use of paths in vertical circulation; (f) use of rooms by the public; (g) use of equipment and facilities used in the provision of the service; (h) use of toilets and sanitary facilities; (i) use of exits, evacuation routes and concepts for emergency planning; (j) communication and orientation via more than one sensory channel; (k) use of facilities and buildings for their foreseeable purpose; (l) protection from hazards in the environment indoors and outdoors. ANNEX IV CONFORMITY ASSESSMENT PROCEDURE – PRODUCTS 1. Internal production control Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 of this Annex, and ensures and declares on its sole responsibility that the product concerned satisfy the appropriate requirements of this Directive. 2. Technical documentation The manufacturer shall establish the technical documentation. The technical documentation shall make it possible to assess the conformity of the product to the relevant accessibility requirements referred to in Article 4 and, in case the manufacturer relied on Article 14, to demonstrate that relevant accessibility requirements would introduce a fundamental alteration or impose a disproportionate burden. The technical documentation shall specify only the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever applicable, contain at least the following elements: (a) a general description of the product; (b) a list of the harmonised standards and technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the relevant accessibility requirements referred to in Article 4 where those harmonised standards or technical specifications have not been applied; in the event of partly applied harmonised standards or technical specifications, the technical documentation shall specify the parts which have been applied. 3. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the products with the technical documentation referred to in point 2 of this Annex and with the accessibility requirements of this Directive. 4. CE marking and EU declaration of conformity 4.1. The manufacturer shall affix the CE marking referred to in this Directive to each individual product that satisfies the applicable requirements of this Directive. 4.2. The manufacturer shall draw up a written EU declaration of conformity for a product model. The EU declaration of conformity shall identify the product for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. 5. Authorised representative The manufacturer’s obligations set out in point 4 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate. ANNEX V INFORMATION ON SERVICES MEETING ACCESSIBILITY REQUIREMENTS 1. The service provider shall include the information assessing how the service meets the accessibility requirements referred to in Article 4 in the general terms and conditions, or equivalent document. The information shall describe the applicable requirements and cover, as far as relevant for the assessment the design and the operation of the service. In addition to the consumer information requirements of Directive 2011/83/EU, the information shall, where applicable, contain the following elements: (a) a general description of the service in accessible formats; (b) descriptions and explanations necessary for the understanding of the operation of the service; (c) a description of how the relevant accessibility requirements set out in Annex I are met by the service. 2. To comply with point 1 of this Annex the service provider may apply in full or in part the harmonised standards and technical specifications, for which references have been published in the Official Journal of the European Union. 3. The service provider shall provide information demonstrating that the service delivery process and its monitoring ensure compliance of the service with point 1 of this Annex and with the applicable requirements of this Directive. ANNEX VI CRITERIA FOR ASSESSMENT OF DISPROPORTIONATE BURDEN Criteria to carry out and document the assessment: 1. Ratio of the net costs of compliance with accessibility requirements to the overall costs (operating and capital expenditures) of manufacturing, distributing or importing the product or providing the service for the economic operators. Elements to use to assess the net costs of compliance with accessibility requirements: (a) criteria related to one-off organisational costs to take into account in the assessment: (i) costs related to additional human resources with accessibility expertise; (ii) costs related to training human resources and acquiring competences on accessibility; (iii) costs of development of a new process for including accessibility in the product development or service provision; (iv) costs related to development of guidance material on accessibility; (v) one-off costs of understanding the legislation on accessibility; (b) criteria related to on-going production and development costs to take into account in the assessment: (i) costs related to the design of the accessibility features of the product or service; (ii) costs incurred in the manufacturing processes; (iii) costs related to testing the product or service for accessibility; (iv) costs related to establishing documentation. 2. The estimated costs and benefits for the economic operators, including production processes and investments, in relation to the estimated benefit for persons with disabilities, taking into account the amount and frequency of use of the specific product or service. 3. Ratio of the net costs of compliance with accessibility requirements to the net turnover of the economic operator. Elements to use to assess the net costs of compliance with accessibility requirements: (a) criteria related to one-off organisational costs to take into account in the assessment: (i) costs related to additional human resources with accessibility expertise; (ii) costs related to training human resources and acquiring competences on accessibility; (iii) costs of development of a new process for including accessibility in the product development or service provision; (iv) costs related to development of guidance material on accessibility; (v) one off costs of understanding the legislation on accessibility; (b) criteria related to on-going production and development costs to take into account in the assessment: (i) costs related to the design of the accessibility features of the product or service; (ii) costs incurred in the manufacturing processes; (iii) costs related to testing the product or service for accessibility; (iv) costs related to establishing documentation.

Accessibility of products and services Accessibility of products and services SUMMARY OF: Directive (EU) 2019/882 on the accessibility requirements for products and services WHAT IS THE AIM OF THE DIRECTIVE? It aims to harmonise accessibility* requirements for certain products* and services so the EU’s internal market operates smoothly by eliminating and preventing any free-movement barriers that may exist because of divergent national legislation. It aims to bring benefits to businesses, people with disabilities* and the elderly. Applying accessibility requirements will clarify the existing accessibility obligation in EU law, particularly in public procurement and structural funds. It is known as the European accessibility act. KEY POINTS The legislation will apply from 28 June 2025 to the following. Products: computers and operating systems;payment terminals and certain self-service terminals such as ATMs, ticketing and check-in machines, interactive self-service information terminals;smartphones and other equipment for accessing telecommunication services;TV equipment involving digital television services;e-readers. Services: telephony services;services to access audiovisual media services;certain elements of air, bus, rail and water transport services such as websites, mobile services, electronic tickets, information;consumer banking;e-books;e-commerce;answer to emergency calls to the single European number ‘112’. The legislation does not apply to: pre-recorded time-based media, such as videos and slides or office file formats published before 28 June 2025; online maps if essential information is provided in an accessible digital way; websites and other forms of archive containing content not updated or edited after 28 June 2025; microenterprises providing services. Specific accessibility requirements apply to all products and services covered by the legislation, provided these do not alter their basic nature or impose a disproportionate burden on operators. Products must: be designed and produced to maximise their use by people with disabilities; comply with detailed rules on information and instructions, user interface and functionality design, support services and packaging. Services must: provide information about the service, its accessibility features and facilities; make websites and mobile devices easily accessible; support systems, such as help desks, call centres and training to provide information on accessibility; apply practices, policies and procedures to address the needs of people with disabilities. Specific rules apply to different services (electronic communications, audiovisual, air, bus, rail, water and urban transport, consumer banking, e-books, e-commerce and the answering to emergency 112 phone number). EU countries may decide to require the compliance of the built environment where services are provided with accessibility requirements. Annex II provides non-binding examples of how the various accessibility requirements may be met. The legislation requires the following. Manufacturers must: design and manufacture products according to the directive, taking into account any subsequent changes in the harmonised standards;draw up the necessary technical documentation, carry out the conformity procedure and keep the information for 5 years;provide clear identification on their products and their own contact details;accompany the product with easily understood instructions and safety information. Importers must: ensure the product has passed the conformity assessment procedure, has the necessary technical documentation, including instructions in a language users can easily understand, and bears the CE marking;refuse to place on the market a product they believe does not meet the accessibility requirements and to inform the manufacturer and market surveillance authorities. Service providers must: design and provide services according to the directive;make available to the public written and oral information easily accessible to people with disabilities on the service they offer and how this meets the accessibility requirements;ensure procedures are in place to continue conforming with the accessibility requirements and take into account any changes. Manufacturers, importers and distributors must act immediately if they discover the product no longer complies with the legislation. EU countries must: ensure all products and services covered by the legislation comply with its accessibility requirements; on request supply the public with information on how companies implement the requirements; implement and update procedures to: check the compliance of services with the directive,follow up complaints or reports on non-compliance,verify that the company has remedied the failing; provide ways, including legal action, to ensure compliance and penalties for any breach of the law. The European Commission: may adopt delegated and implementing acts to amend technical aspects of the directive; may request the European standardisation organisations to draft harmonised standards on accessibility requirements or adopt technical specifications under certain conditions; establishes a working group of representatives of authorities for market surveillance and services’ compliance and of stakeholders including disability organisations to: promote exchange of information and best practice,foster cooperation between authorities and stakeholders,provide advice; submits, by 28 June 2030 and every 5 years thereafter, a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the application of the legislation. FROM WHEN DOES THE DIRECTIVE APPLY? It has to become law in the EU countries by 28 June 2022. EU countries must apply the measures from 28 June 2025. However, EU countries may: delay compliance for the European emergency 112 number until 28 June 2027; give service providers whose facilities were already lawfully in use by 28 June 2025 a further 5 years (until 28 June 2030); allow self-service terminals to operate until the end of their economically useful life, but no longer than 20 years after entering service. BACKGROUND Over 80 million people in the EU live with some kind of disability. With an ageing society, the number is increasing. The EU’s Charter of Fundamental Rights recognises and respects the right of persons with disabilities to benefit from measures designed to ensure their independence, social and occupational integration and participation in the life of the community. The directive defines people with disabilities in line with the United Nations Convention on the Rights of Persons with Disabilities which has been ratified by all EU countries. KEY TERMS Accessibility: design of products, devices, services or environments to be used by people with disabilities on equal basis with others. Products: a substance, preparation or good produced through a manufacturing process (other than food, feed, living plants and animals or products of human, plant and animal origin for future reproduction). Person with disabilities: someone with long-term physical, mental, intellectual or sensory impairment which in interaction with various barriers may hinder their full, effective participation in society on equal basis with others. MAIN DOCUMENT Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, pp. 70-115) RELATED DOCUMENTS Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (recast) (OJ L 321, 17.12.2018, pp. 36-214) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, pp. 82-128) last update 10.09.2019

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16.12.2019 EN Official Journal of the European Union L 325/1 REGULATION (EU) 2019/2144 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Regulation (EU) 2018/858 of the European Parliament and of the Council (3) lays down administrative provisions and technical requirements for the type-approval of all new vehicles, systems, components and separate technical units, with a view to ensuring the proper functioning of the internal market and in order to offer a high level of safety and environmental performance. (2) This Regulation is a regulatory act for the purposes of the EU type-approval procedure laid down by Regulation (EU) 2018/858. Therefore, Annex II to Regulation (EU) 2018/858 should be amended accordingly. The administrative provisions of Regulation (EU) 2018/858, including the provisions on corrective measures and penalties, are fully applicable to this Regulation. (3) Over the past decades, developments in vehicle safety have contributed significantly to the overall reduction in the number of road fatalities and severe injuries. However, 25 300 people died on Union roads in 2017, a figure that has remained constant in the last four years. Moreover, 135 000 people are seriously injured in collisions every year (4). The Union should do its utmost to reduce or to eliminate accidents and injuries in road transport. In addition to safety measures to protect vehicle occupants, the implementation of specific measures to prevent fatalities and injuries of vulnerable road users, such as cyclists and pedestrians, is needed to protect road users outside of the vehicle. Without new initiatives on general road safety, the safety effects of the current approach will no longer be able to off-set the effects of increasing traffic volumes. Therefore, the safety performance of vehicles needs to be further improved as part of an integrated road safety approach and in order to protect vulnerable road users better. (4) Type-approval provisions should ensure that motor vehicle performance levels are assessed in a repeatable and reproducible manner. Therefore, the technical requirements in this Regulation only refer to pedestrians and cyclists, as only these presently exist as formally harmonised testing target subjects. Besides pedestrians and cyclists, vulnerable road users, in general, also include other non-motorised and motorised road users who might use personal mobility solutions without protective bodywork. Moreover, current technology creates a reasonable expectation that advanced systems will also react to other vulnerable road users under normal driving conditions, despite not being specifically tested. The technical requirements in this Regulation should be further adapted to technical progress following an assessment and review process in order to cover all road users who use personal mobility solutions without protective bodywork, such as scooters, self-balancing vehicles and wheelchairs. (5) Technical progress in the area of advanced vehicle safety systems offers new possibilities for reducing casualty numbers. In order to minimise the number of severe injuries and fatalities, a set of new technologies needs to be introduced. (6) Within the context of Regulation (EC) No 661/2009 of the European Parliament and of the Council (5), the Commission assessed the feasibility of extending the existing requirement in that Regulation to install certain systems (for example, advanced emergency braking systems and tyre pressure monitoring systems) in certain categories of vehicles so that it applied to all vehicle categories. The Commission also assessed the technical and economic feasibility and market maturity of imposing a new requirement to install other advanced safety features. Based on those assessments, the Commission published a report for the European Parliament and the Council on 12 December 2016 entitled ‘Saving Lives: Boosting Car Safety in the EU’. The Commission Staff Working Document accompanying that report identified and put forward 19 potential regulatory measures that would be effective in further reducing the number of road accidents and road fatalities and injuries. (7) To ensure technology neutrality, the performance requirements should allow both direct and indirect tyre pressure monitoring systems. (8) Advanced vehicle systems can be more effective in reducing fatalities, decreasing the number of road accidents and mitigating injuries and damage if they are designed to be convenient for users. Therefore, vehicle manufacturers should do their utmost to ensure that the systems and features provided for in this Regulation are developed in such a way that supports the driver. The functioning of those systems and features and their limitations should be explained in a clear and consumer-friendly manner in the motor vehicle’s user instructions. (9) Safety features and warnings used in assisting driving should be easily perceivable by every driver, including the elderly and persons with disabilities. (10) Advanced emergency braking systems, intelligent speed assistance, emergency lane‐keeping systems, driver drowsiness and attention warning, advanced driver distraction warning and reversing detection are safety systems that have a high potential to reduce casualty numbers considerably. In addition, some of those safety systems form the basis of technologies which will also be used for the deployment of automated vehicles. Any such safety systems should function without the use of any kind of biometric information of drivers or passengers, including facial recognition. Therefore, harmonised rules and test procedures for the type-approval of vehicles as regards those systems and for the type‐approval of those systems as separate technical units should be established at Union level. The technological progress of those systems should be taken into account in every evaluation of the existing legislation, in order to be future‐proof, whilst strictly adhering to the principles of privacy and data protection, and to reduce or eliminate accidents and injuries in road transport. It is also necessary to ensure that those systems can be used safely throughout the life cycle of the vehicle. (11) It should be possible to switch off intelligent speed assistance, for instance, when a driver experiences false warnings or inappropriate feedback as a result of inclement weather conditions, temporarily conflicting road markings in construction zones, or misleading, defective or missing road signs. Such a switch-off feature should be under the control of the driver. It should allow for intelligent speed assistance to be switched off for as long as necessary and to be easily switched back on by the driver. When the system is switched off, information about the speed limit may be provided. The system should be always active when switching the ignition on and the driver should always be made aware of whether the system is on or off. (12) It is widely recognised that safety-belts are one of the most important and effective vehicle safety features. Safety-belt reminder systems therefore have the potential to further prevent fatalities or mitigate injuries by increasing the safety-belt wearing rates across the Union. For that reason, under Regulation (EC) No 661/2009 the safety-belt reminder system was made compulsory for the driver seat in all new passenger cars from 2014 in implementation of United Nations (UN) Regulation No 16, which established the relevant technical provisions. As a result of the amendment of that UN Regulation to take account of technical progress, it is obligatory to fit all front and rear seats of M1 and N1 vehicles, as well as all front seats of N2, N3, M2 and M3 vehicles, with safety-belt reminder systems from 1 September 2019 for new types of motor vehicles and 1 September 2021 for all new motor vehicles. (13) The introduction of event data recorders storing a range of crucial anonymised vehicle data, accompanied by requirements for data range, accuracy, resolution and for its collection, storage and retrievability over a short timeframe before, during and immediately after collision (for example, triggered by the deployment of an airbag) is a valuable step in obtaining more accurate, in-depth accident data. All motor vehicles should therefore be required to be equipped with such recorders. Those recorders should be capable of recording and storing data in such a way that the data can only be used by Member States to conduct road safety analysis and assess the effectiveness of specific measures taken without the possibility of identifying the owner or the holder of a particular vehicle on the basis of the stored data. (14) Any processing of personal data, such as information about the driver processed in event data recorders or information about the driver’s drowsiness and attention or the driver’s distraction, should be carried out in accordance with with Union data protection law, in particular Regulation (EU) 2016/679 of the European Parliament and of the Council (6). Event data recorders should operate on a closed-loop system, in which the data stored is overwritten, and which does not allow the vehicle or holder to be identified. In addition, the driver drowsiness and attention warning or advanced driver distraction warning should not continuously record nor retain any data other than what is necessary in relation to the purposes for which they were collected or otherwise processed within the closed-loop system. Furthermore, the processing of personal data collected through the 112-based eCall in-vehicle system is subject to specific safeguards set out in Regulation (EU) 2015/758 of the European Parliament and of the Council (7). (15) Advanced emergency braking systems or emergency lane-keeping systems might not be fully operational in some cases, in particular due to shortcomings in road infrastructure. In those cases, the systems should deactivate themselves and give information about the deactivation to the driver. If they do not deactivate automatically, it should be possible to switch them off manually. Such deactivation should be temporary and should only last for the period when the system is not fully operational. Drivers might also need to override advanced emergency braking system or emergency lane keeping system where the functioning of the system could lead to greater risk or harm. This would ensure that the vehicles are under the driver’s control at all times. Nevertheless such systems could also recognise instances where the driver is incapacitated and intervention by the system is therefore needed in order to prevent an accident being worse than it would otherwise be. (16) Regulation (EC) No 661/2009 exempted vans, sport utility vehicles (SUVs) and multi‐purpose vehicles (MPVs) from safety requirements due to seating height and vehicle mass characteristics. Given the increased rate of market penetration of such vehicles (up from only 3 % in 1996 to 14 % in 2016) and the technological developments in post-crash electric safety checks, those exemptions are outdated and unjustified. Therefore, the exemptions should be removed and the whole range of advanced vehicle system requirements should be applied to those vehicles. (17) Regulation (EC) No 661/2009 achieved significant simplification of Union legislation by replacing 38 Directives with equivalent UN Regulations that are mandatory under Council Decision 97/836/EC (8). In order to achieve further simplification, more Union rules should be replaced with existing UN Regulations that apply in the Union on a compulsory basis. Furthermore, the Commission should promote and support the on-going work at UN level in order to establish, without any delay, and in accordance with the highest road safety standards available, technical requirements for the type-approval of the vehicle safety systems provided by this Regulation. (18) UN Regulations and the amendments thereto which the Union has voted in favour of or that the Union applies, in accordance with Decision 97/836/EC, should be incorporated within the Union type-approval legislation. Accordingly, the power should be delegated to the Commission to amend the list of UN Regulations that apply on a compulsory basis to ensure that that list is kept up-to-date. (19) Regulation (EC) No 78/2009 of the European Parliament and of the Council (9) sets out requirements for the protection of pedestrians, cyclists and other vulnerable road users in the form of compliance tests and limit values for the type-approval of vehicles with regard to their front structure and for the type-approval of frontal protection systems (for example, bull-bars). Since the adoption of Regulation (EC) No 78/2009, technical requirements and test procedures for vehicles have developed further at UN level to take account of technical progress. UN Regulation No 127 laying down uniform provisions concerning the approval of motor vehicles with regard to their pedestrian safety performance (‘UN Regulation No 127’) currently also applies in the Union in respect to type-approval of motor vehicles. (20) Following the adoption of Regulation (EC) No 79/2009 of the European Parliament and of the Council (10), the technical requirements and test procedures for the type-approval of hydrogen-powered vehicles and hydrogen systems and components, have been further developed at UN level to take account of technical progress. UN Regulation No 134 on uniform provisions concerning the approval of motor vehicles and their components with regard to the safety-related performance of hydrogen-fuelled vehicles (HFCV) (11) (‘UN Regulation No 134’) currently also applies in the Union in respect of type-approval of hydrogen systems in motor vehicles. In addition to those requirements, criteria for the quality of the materials and fuelling receptacles used in hydrogen vehicle systems should be established at Union level. (21) In the interests of clarity, rationality and simplification, Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 should be repealed and replaced by this Regulation. (22) Historically, Union rules have limited the overall length of truck combinations, which resulted in the typical cab-over-engine designs as they maximise the cargo space. However, the high position of the driver led to an increased blind-spot area and poorer direct visibility around the truck cab. This is a major factor in truck accidents involving vulnerable road users. The number of casualties could be reduced significantly by improving direct vision. Requirements should therefore be introduced to improve direct vision to enhance the direct visibility of pedestrians, cyclists and other vulnerable road users from the driver’s seat by reducing to the greatest possible extent the blind spots in front and to the side of the driver. The specificities of different categories of vehicles should be taken into account. (23) Automated vehicles have the potential to make a huge contribution to reducing road fatalities, given that more than 90 % of road accidents are estimated to result from some level of human error. As automated vehicles will gradually take over the tasks of the driver, harmonised rules and technical requirements for automated vehicle systems, including those regarding verifiable safety assurance for decision-making by automated vehicles, should be adopted at Union level, while respecting the principle of technological neutrality, and promoted at international level in the framework of the UNECE’s World Forum for Harmonization of Vehicle Regulations (WP.29). (24) Road users such as pedestrians and cyclists, as well as drivers of non-automated vehicles that cannot receive electronic vehicle-to-vehicle information about the behaviour of an automated vehicle, should be kept informed about that behaviour by conventional means as provided for in UN Regulations or other regulatory acts as soon as possible after their entry into force. (25) Vehicle platooning has the potential to bring about safer, cleaner and more efficient transport in the future. In anticipation of the introduction of platooning technology and the relevant standards, a regulatory framework with harmonised rules and procedures will be needed. (26) The connectivity and automation of vehicles increase the possibility for unauthorised remote access to in-vehicle data and the illegal modification of software over the air. In order to take into account such risks, UN Regulations or other regulatory acts on cyber security should be applied on a mandatory basis as soon as possible after their entry into force. (27) Software modifications can significantly change vehicle functionalities. Harmonised rules and technical requirements for software modifications should be established in line with the type-approval procedures. Therefore, UN Regulations or other regulatory acts regarding software update processes should be applied on a mandatory basis as soon as possible after their entry into force. However, those security measures should not compromise the obligations of the vehicle manufacturer to provide access to comprehensive diagnostic information and in-vehicle data relevant to vehicle repair and maintenance. (28) The Union should continue to promote the development of technical requirements for tyre noise, rolling resistance and wet grip performance of tyres at the UN level. This is because UN Regulation No 117 on uniform provisions concerning the approval of tyres with regard to rolling sound emissions and/or to adhesion on wet surfaces and/or to rolling resistance (12) (‘UN Regulation No 117’) now contains these detailed provisions. The process of adapting the requirements on tyres to take account of technical progress should be rapidly and ambitiously continued at UN level, in particular to ensure that tyre performance is also assessed at the end of a tyre’s life in its worn condition and to promote the idea that tyres should meet the requirements throughout their life and not be replaced prematurely. Existing requirements in Regulation (EC) No 661/2009 relating to tyre performance should be replaced by equivalent UN Regulations. (29) In order to ensure the effectiveness of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission to supplement this Regulation in respect of type-approval requirements concerning advanced vehicle systems and to amend this Regulation in respect of Annex II thereof to take into account technical progress and regulatory developments. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (13). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (30) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (14). (31) In view of the alignment of the Union legislation referring to the regulatory procedure with scrutiny with the legal framework introduced by the TFEU and in order to further simplify the Union legislation in the field of vehicle safety, the following Regulations should be repealed and replaced by implementing acts adopted under this Regulation: — Commission Regulation (EC) No 631/2009 (15), — Commission Regulation (EU) No 406/2010 (16), — Commission Regulation (EU) No 672/2010 (17), — Commission Regulation (EU) No 1003/2010 (18), — Commission Regulation (EU) No 1005/2010 (19), — Commission Regulation (EU) No 1008/2010 (20), — Commission Regulation (EU) No 1009/2010 (21), — Commission Regulation (EU) No 19/2011 (22), — Commission Regulation (EU) No 109/2011 (23), — Commission Regulation (EU) No 458/2011 (24), — Commission Regulation (EU) No 65/2012 (25), — Commission Regulation (EU) No 130/2012 (26), — Commission Regulation (EU) No 347/2012 (27), — Commission Regulation (EU) No 351/2012 (28), — Commission Regulation (EU) No 1230/2012 (29), — Commission Regulation (EU) 2015/166 (30). (32) Given that EU type-approvals granted in accordance with Regulation (EC) No 78/2009, Regulation (EC) No 79/2009 or Regulation (EC) No 661/2009 and their implementing measures are to be considered equivalent to those granted in accordance with this Regulation, unless the relevant requirements are changed by this Regulation or until they are modified by the delegated acts or implementing acts adopted pursuant to this Regulation, transitional provisions are needed to ensure that such approvals are not invalidated. (33) The dates for refusal to grant EU type-approval, refusal of vehicle registration and prohibition of the placing on the market or entry into service of components and separate technical units should be laid down for each regulated item. (34) Since the objective of this Regulation, namely ensuring the proper functioning of the internal market through the introduction of harmonised technical requirements concerning the safety and environmental performance of motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (35) Detailed technical requirements and adequate test procedures, as well as provisions concerning uniform procedures and technical specifications, for type-approval of motor vehicles and their trailers, and of systems, components and separate technical units should be laid down in delegated acts and implementing acts sufficiently in advance before their date of application in order to allow enough time for manufacturers to adapt to the requirements of this Regulation and the delegated acts and implementing acts adopted pursuant to it. Some vehicles are produced in small quantities. Therefore, it is appropriate that requirements set out in this Regulation and the delegated acts and implementing acts adopted pursuant to it take into account such vehicles or classes of vehicles where such requirements are incompatible with the use or design of such vehicles, or where the additional burden imposed by them is disproportionate. Therefore, the application of this Regulation should be deferred, HAVE ADOPTED THIS REGULATION: CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS Article 1 Subject matter This Regulation establishes requirements: (a) for the type-approval of vehicles, and of systems, components and separate technical units designed and constructed for vehicles, with regard to their general characteristics and safety, and to the protection and safety of vehicle occupants and vulnerable road users; (b) for the type-approval of vehicles, in respect of tyre pressure monitoring systems, with regard to their safety, fuel efficiency and CO2 emissions; and (c) for the type-approval of newly-manufactured tyres with regard to their safety and environmental performance. Article 2 Scope This Regulation applies to vehicles of categories M, N and O, as defined in Article 4 of Regulation (EU) 2018/858, and to systems, components and separate technical units designed and constructed for such vehicles. Article 3 Definitions For the purposes of this Regulation, the definitions laid down in Article 3 of Regulation (EU) 2018/858 apply. In addition, the following definitions apply: (1) ‘vulnerable road user’ means non-motorised road users, including, in particular, cyclists and pedestrians, as well as users of powered two-wheelers; (2) ‘tyre pressure monitoring system’ means a system fitted on a vehicle which can evaluate the pressure of the tyres or the variation of pressure over time and transmit corresponding information to the user while the vehicle is running; (3) ‘intelligent speed assistance’ means a system to aid the driver in maintaining the appropriate speed for the road environment by providing dedicated and appropriate feedback; (4) ‘alcohol interlock installation facilitation’ means a standardised interface that facilitates the fitting of aftermarket alcohol interlock devices in motor vehicles; (5) ‘driver drowsiness and attention warning’ means a system that assesses the driver’s alertness through vehicle systems analysis and warns the driver if needed; (6) ‘advanced driver distraction warning’ means a system that helps the driver to continue to pay attention to the traffic situation and that warns the driver when he or she is distracted; (7) ‘emergency stop signal’ means a light-signalling function to indicate to other road users to the rear of the vehicle that a high retardation force is being applied to the vehicle relative to the prevailing road conditions; (8) ‘reversing detection’ means a system to make the driver aware of people and objects at the rear of the vehicle with the primary aim of avoiding collisions when reversing; (9) ‘lane departure warning system’ means a system to warn the driver that the vehicle is drifting out of its travel lane; (10) ‘advanced emergency braking system’ means a system which can automatically detect a potential collision and activate the vehicle braking system to decelerate the vehicle with the purpose of avoiding or mitigating a collision; (11) ‘emergency lane-keeping system’ means a system that assists the driver in keeping a safe position of the vehicle with respect to the lane or road boundary, at least when a lane departure occurs or is about to occur and a collision might be imminent; (12) ‘vehicle master control switch’ means the device by which the vehicle’s on-board electronics system is brought, from being switched off, as in the case where a vehicle is parked without the driver being present, to normal operation mode; (13) ‘event data recorder’ means a system with the only purpose of recording and storing critical crash-related parameters and information shortly before, during and immediately after a collision; (14) ‘frontal protection system’ means a separate structure or structures, such as a bull bar, or a supplementary bumper which, in addition to the original‐equipment bumper, is intended to protect the external surface of the vehicle from damage in the event of a collision with an object, with the exception of structures having a mass of less than 0,5 kg, intended to protect only the vehicle’s lights; (15) ‘bumper’ means any front, lower, outer structures of a vehicle, including attachments thereto, which are intended to give protection to a vehicle when involved in a low speed frontal collision with another vehicle; it does not include however any frontal protection system; (16) ‘hydrogen-powered vehicle’ means any motor vehicle that uses hydrogen as fuel to propel the vehicle; (17) ‘hydrogen system’ means an assembly of hydrogen components and connecting parts fitted on a hydrogen-powered vehicle, excluding the hydrogen-powered propulsion system or the auxiliary power unit; (18) ‘hydrogen-powered propulsion system’ means the energy converter used to propel the vehicle; (19) ‘hydrogen component’ means hydrogen containers and all other parts of hydrogen‐powered vehicles that are in direct contact with hydrogen or which form part of a hydrogen system; (20) ‘hydrogen container’ means the component within the hydrogen system that stores the primary volume of hydrogen fuel; (21) ‘automated vehicle’ means a motor vehicle designed and constructed to move autonomously for certain periods of time without continuous driver supervision but in respect of which driver intervention is still expected or required; (22) ‘fully automated vehicle’ means a motor vehicle that has been designed and constructed to move autonomously without any driver supervision; (23) ‘driver availability monitoring system’ means a system to assess whether the driver is in a position to take over the driving function from an automated vehicle in particular situations, where appropriate; (24) ‘vehicle platooning’ means the linking of two or more vehicles in a convoy using connectivity technology and automated driving support systems which allow the vehicles to maintain automatically a set, close distance between each other when connected for certain parts of a journey and to adapt to changes in the movement of the lead vehicle with little to no action from the drivers; (25) ‘maximum mass’ means the technically permissible maximum laden mass stated by the manufacturer; (26) ‘A-pillar’ means the foremost and outermost roof support extending from the chassis to the roof of the vehicle. CHAPTER II OBLIGATIONS OF MANUFACTURERS Article 4 General obligations and technical requirements 1. Manufacturers shall demonstrate that all new vehicles that are placed on the market, registered or entered into service, and all new systems, components and separate technical units that are placed on the market or entered into service, are type-approved in accordance with the requirements of this Regulation and of the delegated acts and implementing acts adopted pursuant to it. 2. Type-approval in accordance with the UN Regulations listed in Annex I shall be considered as EU type-approval in accordance with the requirements of this Regulation and of the delegated acts and implementing acts adopted pursuant to it. 3. The Commission is empowered to adopt delegated acts in accordance with Article 12 to amend Annex I in order to take account of technical progress and regulatory developments by introducing and updating references to the UN Regulations, and relevant series of amendments, that apply on a compulsory basis. 4. Manufacturers shall ensure that vehicles are designed, constructed and assembled so as to minimise the risk of injury to vehicle occupants and vulnerable road users. 5. Manufacturers shall also ensure that vehicles, systems, components and separate technical units comply with the applicable requirements listed in Annex II with effect from the dates specified in that Annex, with the detailed technical requirements and test procedures laid down in the delegated acts and with the uniform procedures and technical specifications laid down in the implementing acts adopted pursuant to this Regulation, including the requirements relating to: (a) restraint systems, crash testing, fuel system integrity and high voltage electrical safety; (b) vulnerable road users, vision and visibility; (c) vehicle chassis, braking, tyres and steering; (d) on-board instruments, electrical system, vehicle lighting and protection against unauthorised use including cyberattacks; (e) driver and system behaviour; and (f) general vehicle construction and features. 6. The Commission is empowered to adopt delegated acts in accordance with Article 12 to amend Annex II in order to take account of technical progress and regulatory developments, in particular in relation to the matters listed in points (a) to (f) of paragraph 5 of this Article as well as those referred to in points (a) to (g) of Article 6(1), Article 7(2), (3), (4) and (5), Article 9(2), (3) and (5) and Article 11(1), and with a view to ensuring a high level of general safety of vehicles, systems, components and separate technical units and a high level of protection of vehicle occupants and vulnerable road users, by introducing and updating references to UN Regulations, as well as to delegated acts and implementing acts. 7. The Commission shall by means of implementing acts adopt provisions concerning uniform procedures and technical specifications for the type-approval of vehicles, systems, components and separate technical units with regard to the requirements listed in Annex II. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 13(2). They shall be published at least 15 months before the applicable dates specified in Annex II. Article 5 Specific provisions relating to tyre pressure monitoring systems and tyres 1. Vehicles shall be equipped with an accurate tyre pressure monitoring system capable, over a wide range of road and environmental conditions, of giving an in-vehicle warning to the driver when a loss of pressure occurs in a tyre. 2. Tyre pressure monitoring systems shall be designed to avoid resetting or recalibration at a low tyre pressure. 3. All tyres placed on the market shall meet the safety and environmental performance requirements set out in the relevant regulatory acts listed in Annex II. 4. The Commission shall by means of implementing acts adopt provisions concerning uniform procedures and technical specifications for: (a) the type-approval of vehicles with regard to their tyre pressure monitoring systems; (b) the type-approval of tyres, including technical specifications concerning their installation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 13(2). They shall be published at least 15 months before the applicable dates specified in Annex II. Article 6 Advanced vehicle systems for all motor vehicle categories 1. Motor vehicles shall be equipped with the following advanced vehicle systems: (a) intelligent speed assistance; (b) alcohol interlock installation facilitation; (c) driver drowsiness and attention warning; (d) advanced driver distraction warning; (e) emergency stop signal; (f) reversing detection; and (g) event data recorder. 2. Intelligent speed assistance shall meet the following minimum requirements: (a) it shall be possible for the driver to be made aware through the accelerator control, or through dedicated, appropriate and effective feedback, that the applicable speed limit is exceeded; (b) it shall be possible to switch off the system; information about the speed limit may still be provided, and intelligent speed assistance shall be in normal operation mode upon each activation of the vehicle master control switch; (c) the dedicated and appropriate feedback shall be based on speed limit information obtained through the observation of road signs and signals, based on infrastructure signals or electronic map data, or both, made available in-vehicle; (d) it shall not affect the possibility, for the drivers, of exceeding the system’s prompted vehicle speed; (e) its performance targets shall be set in order to avoid or minimise the error rate under real driving conditions. 3. Driver drowsiness and attention warning and advanced driver distraction warning systems shall be designed in such a way that those systems do not continuously record nor retain any data other than what is necessary in relation to the purposes for which they were collected or otherwise processed within the closed-loop system. Furthermore, those data shall not be accessible or made available to third parties at any time and shall be immediately deleted after processing. Those systems shall also be designed to avoid overlap and shall not prompt the driver separately and concurrently or in a confusing manner where one action triggers both systems. 4. Event data recorders shall meet the following requirements in particular: (a) the data that they are capable of recording and storing with respect of the period shortly before, during and immediately after a collision shall include the vehicle’s speed, braking, position and tilt of the vehicle on the road, the state and rate of activation of all its safety systems, 112-based eCall in-vehicle system, brake activation and relevant input parameters of the on-board active safety and accident avoidance systems, with high level of accuracy and ensured survivability of data; (b) they cannot be deactivated; (c) the way in which they are capable of recording and storing data shall be such that: (i) they operate on a closed-loop system; (ii) the data that they collect is anonymised and protected against manipulation and misuse; and (iii) the data that they collect enables precise vehicle type, variant and version, and in particular the active safety and accident avoidance systems fitted to the vehicle, to be identified; and (d) the data that they are capable of recording can be made available to national authorities, on the basis of Union or national law, only for the purpose of accident research and analysis, including for the purposes of type approval of systems and components and in compliance with Regulation (EU) 2016/679, over a standardised interface. 5. An event data recorder shall not be capable of recording and storing the last four digits of the vehicle indicator section of the vehicle identification number or any other information which could allow the individual vehicle itself, its owner or holder, to be identified. 6. The Commission shall adopt delegated acts in accordance with Article 12 supplementing this Regulation by laying down detailed rules concerning the specific test procedures and technical requirements for: (a) the type-approval of vehicles with regard to the advanced vehicle systems listed in paragraph 1; (b) the type-approval of the advanced vehicle systems listed in points (a), (f) and (g) of paragraph 1 as separate technical units. Those delegated acts shall be published at least 15 months before the applicable dates specified in Annex II. Article 7 Specific requirements relating to passenger cars and light commercial vehicles 1. In addition to the other requirements of this Regulation and of the delegated acts and implementing acts adopted pursuant to it that are also applicable to vehicles of categories M1 and N1, vehicles of those categories shall meet the requirements set out in paragraphs 2 to 5 and the technical specifications set out in the implementing acts referred to in paragraph 6. 2. Vehicles of categories M1 and N1 shall be equipped with advanced emergency braking systems designed and fitted in two phases and providing for: (a) the detection of obstacles and moving vehicles ahead of the motor vehicle in the first phase; (b) extending the detection capability referred to in point (a) to also include pedestrians and cyclists ahead of the motor vehicle in the second phase. 3. Vehicles of categories M1 and N1 shall also be equipped with an emergency lane-keeping system. 4. Advanced emergency braking systems and emergency lane-keeping systems shall meet the following requirements in particular: (a) it shall only be possible to switch off such systems one at a time by a sequence of actions to be carried out by the driver; (b) the systems shall be in normal operation mode upon each activation of the vehicle master control switch; (c) it shall be possible to easily suppress audible warnings, but such action shall not at the same time suppress system functions other than audible warnings; (d) it shall be possible for the driver to override such systems. 5. Vehicles of categories M1 and N1 shall be designed and constructed to provide for an enlarged head impact protection zone with the aim of enhancing the protection of vulnerable road users and mitigating their potential injuries in the event of a collision. 6. The Commission shall by means of implementing acts adopt provisions concerning uniform procedures and technical specifications for the type-approval of vehicles with regard to the requirements laid down in paragraphs 2 to 5 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 13(2). They shall be published at least 15 months before the applicable dates specified in Annex II. Article 8 Frontal protection systems for passenger cars and light commercial vehicles 1. Frontal protection systems, whether fitted as original equipment to vehicles of categories M1 and N1 or made available on the market as separate technical units for such vehicles, shall comply with the requirements laid down in paragraph 2 and with the technical specifications set out in the implementing acts referred to in paragraph 3. 2. Frontal protection systems made available on the market as separate technical units shall be accompanied by a detailed list of the vehicle types, variants and versions for which the frontal protection system is type-approved, as well as by clear assembly instructions. 3. The Commission shall by means of implementing acts adopt provisions concerning uniform procedures and technical specifications for the type-approval of frontal protection systems, including technical specifications concerning their construction and installation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 13(2). They shall be published at least 15 months before the applicable dates specified in Annex II. Article 9 Specific requirements relating to buses and trucks 1. In addition to the other requirements of this Regulation and of the delegated acts and implementing acts adopted pursuant to it that are also applicable to vehicles of categories M2, M3, N2 and N3, vehicles of those categories shall meet the requirements laid down in paragraphs 2 to 5 and the technical specifications set out in the implementing acts referred to in paragraph 7. Vehicles of categories M2 and M3, shall also meet the requirement laid down in paragraph 6. 2. Vehicles of categories M2, M3, N2 and N3 shall be equipped with a lane departure warning system and an advanced emergency braking system, both of which shall comply with the the technical specifications set out in the implementing acts referred to in paragraph 7. 3. Vehicles of categories M2, M3, N2 and N3 shall be equipped with advanced systems that are capable of detecting pedestrians and cyclists located in close proximity to the front or nearside of the vehicle and of providing a warning or avoiding collision with such vulnerable road users. 4. With respect of systems referred to in paragraphs 2 and 3, they shall meet the following requirements in particular: (a) it shall only be possible to switch off such systems one at a time by a sequence of actions to be carried out by the driver; (b) the systems shall be in normal operation mode upon each activation of the vehicle master control switch; (c) it shall be possible to easily suppress audible warnings, but such action shall not at the same time suppress system functions other than audible warnings; (d) it shall be possible for the driver to override such systems. 5. Vehicles of categories M2, M3, N2 and N3 shall be designed and constructed to enhance the direct visibility of vulnerable road users from the driver seat, by reducing to the greatest possible extent the blind spots in front of and to the side of the driver, while taking into account the specificities of different categories of vehicles. 6. Vehicles of categories M2 and M3 with a capacity exceeding 22 passengers in addition to the driver and constructed with areas for standing passengers to allow frequent passenger movement shall be designed and constructed to be accessible by persons with reduced mobility, including wheelchair users. 7. The Commission shall by means of implementing acts adopt provisions concerning uniform procedures and technical specifications for: (a) the type-approval of vehicles with regard to the requirements laid down in paragraphs 2 to 5 of this Article; (b) the type-approval of the systems referred to in paragraph 3 of this Article as separate technical units. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 13(2). Where those implementing acts concern the requirements laid down in paragraphs 2, 3 and 4 of this Article, they shall be published at least 15 months before the applicable dates specified in Annex II. Where those implementing acts concern the requirements laid down in paragraph 5 of this Article, they shall be published at least 36 months before the applicable dates specified in Annex II. Article 10 Specific requirements relating to hydrogen-powered vehicles 1. In addition to the other requirements of this Regulation and of the delegated acts and implementing acts adopted pursuant to it that are also applicable to vehicles of categories M and N, hydrogen-powered vehicles of those categories, their hydrogen systems and components of such systems shall comply with the technical specifications set out in the implementing acts referred to in paragraph 3. 2. Manufacturers shall ensure that hydrogen systems and hydrogen components are installed in accordance with the technical specifications set out in the implementing acts referred to in paragraph 3. Manufacturers shall also make available, if necessary information for the purposes of inspection of hydrogen systems and components during the service life of hydrogen-powered vehicles. 3. The Commission shall by means of implementing acts adopt provisions concerning uniform procedures and technical specifications for the type-approval of hydrogen‐powered vehicles with regard to their hydrogen systems, including those with regard to material compatibility and fuelling receptacles, and for the type-approval of hydrogen components, including technical specifications for their installation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 13(2). They shall be published at least 15 months before the applicable dates specified in Annex II. Article 11 Specific requirements relating to automated vehicles and fully automated vehicles 1. In addition to the other requirements of this Regulation and of the delegated acts and implementing acts adopted pursuant to it that are applicable to vehicles of the respective categories, automated vehicles and fully automated vehicles shall comply with the technical specifications set out in the implementing acts referred to in paragraph 2 that relate to: (a) systems to replace the driver’s control of the vehicle, including signalling, steering, accelerating and braking; (b) systems to provide the vehicle with real-time information on the state of the vehicle and the surrounding area; (c) driver availability monitoring systems; (d) event data recorders for automated vehicles; (e) harmonised format for the exchange of data for instance for multi‐brand vehicle platooning; (f) systems to provide safety information to other road users. However, those technical specifications relating to driver availability monitoring systems, referred to in point (c) of the first subparagraph, shall not apply to fully automated vehicles. 2. The Commission shall by means of implementing acts adopt provisions concerning uniform procedures and technical specifications for the systems and other items listed in points (a) to (f) of paragraph 1 of this Article, and for the type-approval of automated and fully automated vehicles with regard to those systems and other items in order to ensure the safe operation of automated and fully automated vehicles on public roads. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 13(2). CHAPTER III FINAL PROVISIONS Article 12 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 4(3) and (6) and Article 6(6) shall be conferred on the Commission for a period of five years from 5 January 2020. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 4(3) and (6) and Article 6(6) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted under Article 4(3) and (6) and Article 6(6) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 13 Committee procedure 1. The Commission shall be assisted by the Technical Committee — Motor Vehicles (TCMV). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 14 Review and reporting 1. By 7 July 2027 and every five years thereafter, the Commission shall submit an evaluation report to the European Parliament and to the Council on the achievements of the safety measures and systems, including their penetration rates and convenience for the user. The Commission shall investigate whether those safety measures and systems act as intended by this Regulation. Where appropriate, that report shall be accompanied by recommendations, including a legislative proposal to amend the requirements concerning general safety and the protection and safety of vehicle occupants and vulnerable road users, in order to further reduce or to eliminate accidents and injuries in road transport. In particular, the Commission shall evaluate the reliability and efficiency of new intelligent speed assistance systems and the accuracy and error rate of such systems under real driving conditions. Where appropriate, the Commission shall present a legislative proposal. 2. By 31 January of each year, for the previous year, the Commission shall submit to the European Parliament and to the Council a report on the activities of the UNECE’s World Forum for Harmonization of Vehicle Regulations (WP.29) as regards the progress made in the implementation of vehicle safety standards with regard to the requirements set out in Articles 5 to 11 and as regards the position of the Union related to these matters. Article 15 Transitional provisions 1. This Regulation shall not invalidate any EU type-approvals granted to vehicles, systems, components or separate technical units which were granted in accordance with Regulation (EC) No 78/2009, Regulation (EC) No 79/2009 or Regulation (EC) No 661/2009 and their implementing measures, by 5 July 2022, unless the relevant requirements applying to such vehicles, systems, components or separate technical units have been modified, or new requirements have been added, by this Regulation and the delegated acts adopted pursuant to it, as further specified in the implementing acts adopted pursuant to this Regulation. 2. Approval authorities shall continue to grant extensions of EU type-approvals referred to in paragraph 1. 3. By way of derogation from this Regulation, Member States shall continue to permit until the date specified in Annex IV the registration of vehicles, as well as the sale or entry into service of components, which do not comply with the requirements of UN Regulation No 117. Article 16 Implementation dates With respect to vehicles, systems, components and separate technical units, national authorities shall: (a) with effect from the dates specified in Annex II, with respect to a particular requirement listed in that Annex, refuse, on grounds relating to that requirement, to grant EU type‐approval or national type-approval to any new type of vehicle, system, component or separate technical unit that does not comply with the requirements of this Regulation and of the delegated acts and implementing acts adopted pursuant to it; (b) with effect from the dates specified Annex II, with respect to a particular requirement listed in that Annex, consider, on grounds relating to that requirement, certificates of conformity in respect to new vehicles to be no longer valid for the purposes of Article 48 of Regulation (EU) 2018/858, and prohibit the registration of such vehicles, if those vehicles do not comply with the requirements of this Regulation and of the delegated acts and implementing acts adopted pursuant to it; (c) with effect from the dates specified in Annex II, with respect to a particular requirement listed in that Annex, prohibit, on grounds relating to that requirement, the placing on the market or entry into service of components and separate technical units, where they do not comply with the requirements of this Regulation and of the delegated acts and implementing acts adopted pursuant to it. Article 17 Amendments to Regulation (EU) 2018/858 Annex II to Regulation (EU) 2018/858 is amended in accordance with Annex III to this Regulation. Article 18 Repeal 1. Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 and Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 are repealed with effect from the date of application of this Regulation. 2. References to Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 shall be construed as references to this Regulation. Article 19 Entry into force and date of application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 6 July 2022. However, Article 4(3), (6) and (7), Article 5(4), Article 6(6), Article 7(6), Article 8(3), Article 9(7), Article 10(3), Article 11(2) and Articles 12 and 13 shall apply from 5 January 2020. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 27 November 2019. For the European Parliament The President D. M. SASSOLI For the Council The President T. TUPPURAINEN (1) OJ C 440, 6.12.2018, p. 90. (2) Position of the European Parliament of 16 April 2019 (not yet published in the Official Journal) and decision of the Council of 8 November 2019. (3) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1). (4) https://ec.europa.eu/transport/road_safety/sites/roadsafety/files/vademecum_2018.pdf (5) Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, p. 1). (6) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (7) Regulation (EU) 2015/758 of the European Parliament and of the Council of 29 April 2015 concerning type-approval requirements for the deployment of the eCall in-vehicle system based on the 112 service and amending Directive 2007/46/EC (OJ L 123, 19.5.2015, p. 77). (8) Council Decision 97/836/EC of 27 November 1997 with a view to accession by the European Community to the Agreement of the United Nations Economic Commission for Europe concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions (‘Revised 1958 Agreement’) (OJ L 346, 17.12.1997, p. 78). (9) Regulation (EC) No 78/2009 of the European Parliament and of the Council of 14 January 2009 on the type-approval of motor vehicles with regard to the protection of pedestrians and other vulnerable road users, amending Directive 2007/46/EC and repealing Directives 2003/102/EC and 2005/66/EC (OJ L 35, 4.2.2009, p. 1). (10) Regulation (EC) No 79/2009 of the European Parliament and of the Council of 14 January 2009 on type-approval of hydrogen-powered motor vehicles, and amending Directive 2007/46/EC (OJ L 35, 4.2.2009, p. 32). (11) OJ L 129, 17.5.2019, p. 43. (12) OJ L 218, 12.8.2016, p. 1. (13) OJ L 123, 12.5.2016, p. 1. (14) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (15) Commission Regulation (EC) No 631/2009 of 22 July 2009 laying down detailed rules for the implementation of Annex I to Regulation (EC) No 78/2009 of the European Parliament and of the Council on the type-approval of motor vehicles with regard to the protection of pedestrians and other vulnerable road users, amending Directive 2007/46/EC and repealing Directives 2003/102/EC and 2005/66/EC (OJ L 195, 25.7.2009, p. 1). (16) Commission Regulation (EU) No 406/2010 of 26 April 2010 implementing Regulation (EC) No 79/2009 of the European Parliament and of the Council on type-approval of hydrogen-powered motor vehicles (OJ L 122, 18.5.2010, p. 1). (17) Commission Regulation (EU) No 672/2010 of 27 July 2010 concerning type-approval requirements for windscreen defrosting and demisting systems of certain motor vehicles and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 196, 28.7.2010, p. 5). (18) Commission Regulation (EU) No 1003/2010 of 8 November 2010 concerning type-approval requirements for the space for mounting and the fixing of rear registration plates on motor vehicles and their trailers and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 291, 9.11.2010, p. 22). (19) Commission Regulation (EU) No 1005/2010 of 8 November 2010 concerning type-approval requirements for motor vehicle towing devices and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 291, 9.11.2010, p. 36). (20) Commission Regulation (EU) No 1008/2010 of 9 November 2010 concerning type-approval requirements for windscreen wiper and washer systems of certain motor vehicles and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 292, 10.11.2010, p. 2). (21) Commission Regulation (EU) No 1009/2010 of 9 November 2010 concerning type-approval requirements for wheel guards of certain motor vehicles and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 292, 10.11.2010, p. 21). (22) Commission Regulation (EU) No 19/2011 of 11 January 2011 concerning type-approval requirements for the manufacturer’s statutory plate and for the vehicle identification number of motor vehicles and their trailers and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 8, 12.1.2011, p. 1). (23) Commission Regulation (EU) No 109/2011 of 27 January 2011 implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council as regards type-approval requirements for certain categories of motor vehicles and their trailers as regards spray suppression systems (OJ L 34, 9.2.2011, p. 2). (24) Commission Regulation (EU) No 458/2011 of 12 May 2011 concerning type-approval requirements for motor vehicles and their trailers with regard to the installation of their tyres and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 124, 13.5.2011, p. 11). (25) Commission Regulation (EU) No 65/2012 of 24 January 2012 implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council as regards gear shift indicators and amending Directive 2007/46/EC of the European Parliament and of the Council (OJ L 28, 31.1.2012, p. 24). (26) Commission Regulation (EU) No 130/2012 of 15 February 2012 concerning type-approval requirements for motor vehicles with regard to vehicle access and manoeuvrability and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 43, 16.2.2012, p. 6). (27) Commission Regulation (EU) No 347/2012 of 16 April 2012 implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council with respect to type‐approval requirements for certain categories of motor vehicles with regard to advanced emergency braking systems (OJ L 109, 21.4.2012, p. 1). (28) Commission Regulation (EU) No 351/2012 of 23 April 2012 implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council as regards type-approval requirements for the installation of lane departure warning systems in motor vehicles (OJ L 110, 24.4.2012, p. 18). (29) Commission Regulation (EU) No 1230/2012 of 12 December 2012 implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council with regard to type-approval requirements for masses and dimensions of motor vehicles and their trailers and amending Directive 2007/46/EC of the European Parliament and of the Council (OJ L 353, 21.12.2012, p. 31). (30) Commission Regulation (EU) 2015/166 of 3 February 2015 supplementing and amending Regulation (EC) No 661/2009 of the European Parliament and of the Council as regards the inclusion of specific procedures, assessment methods and technical requirements, and amending Directive 2007/46/EC of the European Parliament and of the Council, and Commission Regulations (EU) No 1003/2010, (EU) No 109/2011 and (EU) No 458/2011 (OJ L 28, 4.2.2015, p. 3). ANNEX I List of UN Regulations referred to in Article 4(2) UN Regulation Number Subject Series of amendments published in the OJ OJ Reference Scope covered by the UN Regulation 1 Headlamps emitting an asymmetrical passing beam and/or driving beam equipped with filament lamps R2 and/or HS1 02 series of amendments OJ L 177, 10.7.2010, p. 1 M, N (1) 3 Retro-reflecting devices for power-driven vehicles and their trailers 02 series of amendments OJ L 323, 6.12.2011, p. 1 M, N, O 4 Illumination of rear-registration plates of power-driven vehicles and their trailers Original version of the Regulation OJ L 4, 7.1.2012, p. 17 M, N, O 6 Direction indicators for power-driven vehicles and their trailers 01 series of amendments OJ L 213, 18.7.2014, p. 1 M, N, O 7 Front and rear position (side) lamps, stop-lamps and end‐outline marker lamps for power-driven vehicles and their trailers 02 series of amendments OJ L 285, 30.9.2014, p. 1 M, N, O 8 Motor vehicles headlamps (H1, H2, H3, HB3, HB4, H7, H8, H9, HIR1, HIR2 and/or H11) 05 series of amendments Corrigendum 1 to Revision 4 OJ L 177, 10.7.2010, p. 71 M, N (1) 10 Electromagnetic compatibility 05 series of amendments OJ L 41, 17.2.2017, p. 1 M, N, O 11 Door latches and door retention components 04 series of amendments OJ L 218, 21.8.2019, p. 1 M1, N1 12 Protection of the driver against the steering mechanism in the event of impact 04 series of amendments OJ L 89, 27.3.2013, p. 1 M1, N1 13 Braking of vehicles and trailers 11 series of amendments OJ L 42, 18.2.2016, p. 1 M2, M3, N, O (2) 13-H Braking of passenger cars Original version of the Regulation OJ L 335, 22.12.2015, p. 1 M1, N1 14 Safety-belt anchorages 07 series of amendments OJ L 218, 19.8.2015, p. 27 M, N 16 Safety-belts, restraint systems, child restraint systems and ISOFIX child restraint systems 07 series of amendments OJ L 109, 27.4.2018, p. 1 M, N 17 Seats, their anchorages and any head restraints 08 series of amendments OJ L 230, 31.8.2010, p. 81 M, N 18 Protection of motor vehicles against unauthorised use 03 series of amendments OJ L 120, 13.5.2010, p. 29 M2, M3, N2, N3 19 Power-driven vehicle front fog lamps 04 series of amendments OJ L 250, 22.8.2014, p. 1 M, N 20 Headlamps emitting an asymmetrical passing beam or a driving beam or both and equipped with halogen filament lamps (H4 lamps) 03 series of amendments OJ L 177, 10.7.2010, p. 170 M, N (1) 21 Interior fittings 01 series of amendments OJ L 188, 16.7.2008, p. 32 M1 23 Reversing and manoeuvring lamps for power-driven vehicles and their trailers Original version of the Regulation OJ L 237, 8.8.2014, p. 1 M, N, O 25 Head restraints (headrests), whether or not incorporated in vehicle seats 04 series of amendments Corrigendum 2 to Revision 1 OJ L 215, 14.8.2010, p. 1 M1 26 External projections 03 series of amendments OJ L 215, 14.8.2010, p. 27 M1 28 Audible warning devices and audible signals Original version of the Regulation OJ L 323, 6.12.2011, p. 33 M, N 29 Protection of the occupants of the cab of a commercial vehicle 03 series of amendments OJ L 304, 20.11.2010, p. 21 N 30 Pneumatic tyres for motor vehicles and their trailers (Class C1) 02 series of amendments OJ L 307, 23.11.2011, p. 1 M, N, O 31 Power-driven vehicle’s sealed-beam headlamps (SB) emitting a European asymmetrical passing beam or a driving beam or both 02 series of amendments OJ L 185, 17.7.2010, p. 15 M, N 34 Prevention of fire risks (liquid fuel tanks) 03 series of amendments OJ L 231, 26.8.2016, p. 41 M, N, O 37 Filament lamps for use in approved lamp units of power‐driven vehicles and their trailers 03 series of amendments OJ L 213, 18.7.2014, p. 36 M, N, O 38 Rear fog lamps for power-driven vehicles and their trailers Original version of the Regulation OJ L 4, 7.1.2012, p. 20 M, N, O 39 Speedometer and odometer equipment including its installation 01 series of amendments OJ L 302, 28.11.2018, p. 106 M, N 43 Safety glazing materials and their installation on vehicles 01 series of amendments OJ L 42, 12.2.2014, p. 1 M, N, O 44 Restraining devices for child occupants of power-driven vehicles (‘Child Restraint Systems’) 04 series of amendments OJ L 265, 30.9.2016, p. 1 M, N 45 Headlamps cleaners 01 series of amendments M, N 46 Devices for indirect vision and their installation 04 series of amendments OJ L 237, 8.8.2014, p. 24 M, N 48 Installation of lighting and light-signalling devices on motor vehicles 06 series of amendments OJ L 14, 16.1.2019, p. 42 M, N, O (3) 54 Pneumatic tyres for commercial vehicles and their trailers (Classes C2 and C3) Original version of the Regulation OJ L 307, 23.11.2011, p. 2 M, N, O 55 Mechanical coupling components of combinations of vehicles 01 series of amendments OJ L 153, 15.6.2018, p. 179 M, N, O (3) 58 Rear underrun protective devices (RUPDs) and their installation; Rear underrun protection (RUP) 03 series of amendments OJ L 49, 20.2.2019, p. 1 M, N, O 61 Commercial vehicles with regard to their external projections forward of the cab’s rear panel Original version of the Regulation OJ L 164, 30.6.2010, p. 1 N 64 Temporary‐use spare unit, run-flat tyres/system (and tyre pressure monitoring system) 02 series of amendments OJ L 310, 26.11.2010, p. 18 M1, N1 66 Strength of the superstructure of large passenger vehicles 02 series of amendments OJ L 84, 30.3.2011, p. 1 M2, M3 67 Motor vehicles using LPG 01 series of amendments OJ L 285, 20.10.2016, p. 1 M, N 73 Lateral protection devices of goods vehicles 01 series of amendments OJ L 122, 8.5.2012, p. 1 N2, N3, O3, O4 77 Parking lamps for power-driven vehicles Original version of the Regulation OJ L 4, 7.1.2012, p. 21 M, N 79 Steering equipment 03 series of amendments OJ L 318, 14.12.2018, p. 1 M, N, O 80 Seats of large passenger vehicles 03 series of amendments OJ L 226, 24.8.2013, p. 20 M2, M3 87 Daytime running lamps for power-driven vehicles Original version of the Regulation OJ L 4, 7.1.2012, p. 24 M, N 89 Speed limitation devices and adjustable speed limitation devices Original version of the Regulation OJ L 4, 7.1.2012, p. 25 M, N (4) 90 Replacement brake lining assemblies, drum-brake linings and discs and drums for power-driven vehicles and their trailers 02 series of amendments OJ L 290, 16.11.2018, p. 54 M, N, O 91 Side-marker lamps for motor vehicles and their trailers Original version of the Regulation OJ L 4, 7.1.2012, p. 27 M, N, O 93 Front underrun protective devices (FUPDs) and their installation; front underrun protection (FUP) Original version of the Regulation OJ L 185, 17.7.2010, p. 56 N2, N3 94 Protection of occupants in the event of a frontal collision 03 series of amendments OJ L 35, 8.2.2018, p. 1 M1 95 Protection of occupants in the event of a lateral collision 03 series of amendments OJ L 183, 10.7.2015, p. 91 M1, N1 97 Vehicle Alarm Systems (VAS) 01 series of amendments OJ L 122, 8.5.2012, p. 19 M1, N1 (5) 98 Motor vehicle headlamps equipped with gas-discharge light sources 01 series of amendments OJ 176, 14.6.2014, p. 64 M, N 99 Gas-discharge light sources for use in approved gas‐discharge lamp units of power-driven vehicles Original version of the Regulation OJ L 320, 17.12.2018, p. 45 M, N 100 Electric safety 02 series of amendments OJ L 302, 28.11.2018, p. 114 M, N 102 Close-coupling device (CCD); fitting of an approved type of CCD Original version of the Regulation OJ L 351, 30.12.2008, p. 44 N2, N3, O3, O4 104 Retro-reflective markings (heavy and long vehicles) Original version of the Regulation OJ L 75, 14.3.2014, p. 29 M2, M3, N, O2, O3, O4 105 Vehicles for the carriage of dangerous goods 05 series of amendments OJ L 4, 7.1.2012, p. 30 N, O 107 General construction of category M2 and M3 vehicles 07 series of amendments OJ L 52, 23.2.2018, p. 1 M2, M3 108 Retreaded pneumatic tyres for passenger cars and their trailers Original version of the Regulation OJ L 181, 4.7.2006, p. 1 M1, O1, O2 109 Retreaded pneumatic tyres for commercial vehicles and their trailers Original version of the Regulation OJ L 181, 4.7.2006, p. 1 M2, M3, N, O3, O4 110 Specific components for CNG and LNG 01 series of amendments OJ L 166, 30.6.2015, p. 1 M, N 112 Motor vehicle headlamps emitting an asymmetrical passing beam or a driving beam or both and equipped with filament lamps and/or LED modules 01 series of amendments OJ L 250, 22.8.2014, p. 67 M, N 114 Replacement Airbag Systems Original version of the Regulation OJ L 373, 27.12.2006, p. 272 M1, N1 115 LPG and CNG retrofit systems Original version of the Regulation OJ L 323, 7.11.2014, p. 91 M, N 116 Protection of motor vehicles against unauthorised use Original version of the Regulation OJ L 45, 16.2.2012, p. 1 M1, N1 (5) 117 Tyres with regard to rolling sound emissions, adhesion on wet surfaces and rolling resistance (Classes C1, C2 and C3) 02 series of amendments OJ L 218, 12.8.2016, p. 1 M, N, O 118 Fire resistance of interior materials in buses 02 series of amendments OJ L 102, 21.4.2015, p. 67 M3 119 Cornering lamps 01 series of amendments OJ L 89, 25.3.2014, p. 101 M, N 121 Location and identification of hand controls, tell-tales and indicators 01 series of amendments OJ L 5, 8.1.2016, p. 9 M, N 122 Heating systems of vehicles Original version of the Regulation OJ L 164, 30.6.2010, p. 231 M, N, O 123 Adaptive front-lighting systems (AFS) for motor vehicles 01 series of amendments OJ L 49, 20.2.2019, p. 24 M, N 124 Replacement wheels Original version of the Regulation OJ L 375, 27.12.2006, p. 568 M1, N1, O1, O2 125 Forward field of vision 01 series of amendments OJ L 20, 25.1.2018, p. 16 M1 126 Partitioning systems Original version of the Regulation M1 127 Pedestrian safety 02 series of amendments M1, N1 128 Light Emitting Diode (LED) light sources Original version of the Regulation OJ L 320, 17.12.2018, p. 63 M, N, O 129 Enhanced Child Restraint Systems Original version of the Regulation OJ L 97, 29.3.2014, p. 21 M, N 130 Lane Departure Warning Systems Original version of the Regulation OJ L 178, 18.6.2014, p. 29 M2, M3, N2, N3 (6) 131 Advanced Emergency Braking Systems 01 series of amendments OJ L 214, 19.7.2014, p. 47 M2, M3, N2, N3 (6) 134 Hydrogen safety Original version of the Regulation OJ L 129, 17.5.2019, p. 43 M, N 135 Pole side impact 01 series of amendments M1, N1 137 Frontal full-width impact 01 series of amendments M1 139 Brake Assist Systems Original version of the Regulation OJ L 269, 26.10.2018, p. 1 M1, N1 140 Electronic Stability Control Systems Original version of the Regulation OJ L 269, 26.10.2018, p. 17 M1, N1 141 Tyre Pressure Monitoring Systems Original version of the Regulation OJ L 269, 26.10.2018, p. 36 M1, N1 (7) 142 Tyre installation Original version of the Regulation M1 145 Child restraint anchorages Original version of the Regulation M1 Notes to the table The series of amendments indicated in the table reflects the version that has been published in the Official Journal of the European Union and is without prejudice to the series of amendments that shall be complied with on the basis of the transitional provisions provided therein. Compliance with a series of amendments adopted after the particular series indicated in the table shall be accepted as an alternative. The dates specified in the relevant series of amendments of the UN Regulations listed in the table, as regards the obligations of Contracting Parties to the ‘Revised 1958 Agreement’, linked to first registration, entry into service, making available on the market, sale, the recognition of type‐approvals, and any similar provisions, apply on a compulsory basis for the purposes of Articles 48 and 50 of Regulation (EU) 2018/858 except where alternative dates are specified in Annex II to this Regulation in which case those alternative dates are to be followed instead. In certain instances, a UN Regulation listed in the table provides in its transitional provisions that as from a specified date, Contracting Parties to the ‘Revised 1958 Agreement’ applying a certain series of amendments to that UN Regulation shall not be obliged to accept or may refuse to accept, for the purpose of national or regional type-approval, a type approved in accordance with a preceding series of amendments, or wording with similar intention and meaning. This shall be construed as a binding provision for national authorities to consider the certificates of conformity to be no longer valid for the purposes of Article 48 of Regulation (EU) 2018/858, except where alternative dates are specified in Annex II to this Regulation in which case those alternative dates are to be followed instead. (1) UN Regulation Nos 1, 8 and 20 are not applicable for EU type-approval of vehicles. (2) The mandatory fitting of a stability control function is required in accordance with the UN Regulations. However, it is also mandatory for vehicles of category N1. (3) Where it is declared by the vehicle manufacturer that a vehicle is suitable for towing loads (point 2.11.5 of the information document referred to in Article 24(1) of Regulation (EU) 2018/858) and any part of a suitable mechanical coupling device, whether fitted or not to the type of motor-vehicle, could (partly) obscure any lighting component and/or the space for mounting and fixing the rear registration plate, the following shall apply: — the motor-vehicle’s user instructions (e.g. owner’s manual, vehicle handbook) shall clearly specify that installation of a mechanical coupling device that cannot be easily removed or repositioned is not permitted, — the instructions shall also clearly specify that, when fitted, a mechanical coupling device must always be removed or repositioned when it is not in use, and — in the case of vehicle system type-approval in accordance with UN Regulation No 55, it shall be ensured that the removal, repositioning and/or alternate location provisions are also fully complied with as regards lighting installation and space for mounting and fixing the rear registration plate. (4) Only Speed Limitation Devices (SLD) and the mandatory installation of SLD on vehicles of category M2, M3, N2 and N3 are concerned. (5) Devices to prevent unauthorised use shall be fitted on vehicles of categories M1 and N1 and immobiliser systems shall be fitted on vehicles of category M1. (6) See explanatory note 4 to the table in Annex II. (7) For vehicles of categories M1 with a maximum mass ≤ 3 500 kg and N1, that are not fitted with twin wheels on an axle. ANNEX II List of the requirements referred to in Article 4(5) and Article 5(3) as well as the dates referred to in Article 16 Subject Regulatory acts Additional specific technical provisions M1 M2 M3 N1 N2 N3 O1 O2 O3 O4 S T U Component Requirements concerning A RESTRAINT SYSTEMS, CRASH TESTING, FUEL SYSTEM INTEGRITY AND HIGH VOLTAGE ELECTRICAL SAFETY A1 Interior fittings UN Regulation No 21 A A2 Seats and head restraints UN Regulation No 17 A A A A A A A3 Bus seats UN Regulation No 80 A A A A4 Safety-belt anchorages UN Regulation No 14 A A A A A A A5 Safety-belts and restraint systems UN Regulation No 16 A A A A A A A A A6 Safety-belt reminders UN Regulation No 16 A A A A A A A7 Partitioning systems UN Regulation No 126 X B A8 Child restraint anchorages UN Regulation No 145 A A9 Child restraint systems UN Regulation No 44 A (1) A (1) A (1) A (1) A (1) A (1) A A A10 Enhanced child restraint systems UN Regulation No 129 X X X X X X B B A11 Front underrun protection UN Regulation No 93 A A A A A12 Rear underrun protection UN Regulation No 58 A A A A A A A A A A A A A13 Lateral protection UN Regulation No 73 A A A A A14 Fuel tank safety UN Regulation No 34 A A A A A A A A A A A A15 Liquified petroleum gas safety UN Regulation No 67 A A A A A A A A16 Compressed and liquified natural gas safety UN Regulation No 110 A A A A A A A A17 Hydrogen safety UN Regulation No 134 A A A A A A A A18 Hydrogen system material qualification A A A A A A A A19 In-use electric safety UN Regulation No 100 A A A A A A A20 Frontal off-set impact UN Regulation No 94 Applies to vehicle categories M1 with a maximum mass ≤ 3 500 kg and N1 with a maximum mass ≤ 2 500 kg. For vehicles with a maximum mass > 2 500 kg, dates in note B apply. A A A21 Frontal full-width impact UN Regulation No 137 Use of the anthropomorphic test device ‘Hybrid III’ crash dummy is permitted until the test device for human occupant restraint ‘THOR’ is available in the UN Regulation. B B A22 Protective steering UN Regulation No 12 A A A A23 Replacement airbag UN Regulation No 114 X X B A24 Cab impact UN Regulation No 29 A A A A25 Side impact UN Regulation No 95 Applies to all vehicles of categories M1 and N1 including those with R point of the lowest seat > 700 mm from ground level. For vehicles having R point of the lowest seat > 700 mm from ground level, dates in Note B apply. A A A26 Pole side impact UN Regulation No 135 B B A27 Rear impact UN Regulation No 34 Applies to vehicle categories M1 with a maximum mass ≤ 3 500 kg and N1. Post‐crash electrical safety requirements shall be ensured. B B Requirements concerning B VULNERABLE ROAD USERS, VISION AND VISIBILITY B1 Pedestrian leg and head protection UN Regulation No 127 A A B2 Enlarged head impact zone UN Regulation No 127 Child and adult headform test area are bounded by the ‘adult wrap-around-distance’ of 2 500 mm or ‘windscreen rear reference line’ whichever is more forward. Headform contact with A-pillars, windscreen header and cowl is excluded, but shall be monitored. C C B3 Frontal protection system X X A B4 Advanced emergency braking for pedestrian and cyclist C C B5 Pedestrian and cyclist collision warning B B B B B B6 Blind spot information system B B B B B B7 Reversing detection B B B B B B B B8 Forward vision UN Regulation No 125 Applies to vehicle categories M1 and N1 A C B9 Heavy-duty vehicles direct vision D D D D B10 Safety glazing UN Regulation No 43 A A A A A A A A A A A B11 Defrost/demist A A (2) A (2) A (2) A (2) A (2) B12 Wash/wipe A A (3) A (3) A (3) A (3) A (3) A B13 Indirect vision devices UN Regulation No 46 A A A A A A A Requirements concerning C VEHICLE CHASSIS, BRAKING, TYRES AND STEERING C1 Steering equipment UN Regulation No 79 A A A A A A A A A A C2 Lane departure warning system UN Regulation No 130 A (4) A (4) A (4) A (4) C3 Emergency lane keeping system B (6) B (6) C4 Braking UN Regulation No 13 UN Regulation No 13-H A A A A A A A A A A C5 Replacement braking parts UN Regulation No 90 X X X X X X X X X X A C6 Brake assist UN Regulation No 139 A A C7 Stability control UN Regulation No 13 UN Regulation No 140 A A A A A A A A A A C8 Advanced emergency braking on heavy-duty vehicles UN Regulation No 131 A (4) A (4) A (4) A (4) C9 Advanced emergency braking on light-duty vehicles B B C10 Tyre safety and environmental performance UN Regulation No 30 UN Regulation No 54 UN Regulation No 117 A test procedure for worn tyres shall also be ensured; the dates in note C apply. X X X X X X X X X X A C11 Spare wheels and run‐flat systems UN Regulation No 64 A (1) A (1) C12 Retreaded tyres UN Regulation No 108 UN Regulation No 109 X X X X X X X X X X A C13 Tyre pressure monitoring for light-duty vehicles UN Regulation No 141 Applies to vehicle categories M1 with a maximum mass ≤ 3 500 kg and N1. A B C14 Tyre pressure monitoring for heavy‐duty vehicles B B B B B B C15 Tyre installation UN Regulation No 142 Applies to all vehicle categories. A A A A A A A A A A C16 Replacement wheels UN Regulation No 124 X X X X B Requirements concerning D ON-BOARD INSTRUMENTS, ELECTRICAL SYSTEM, VEHICLE LIGHTING AND PROTECTION AGAINST UNAUTHORISED USE, INCLUDING CYBERATTACKS D1 Audible warning UN Regulation No 28 A A A A A A A D2 Radio interference (electromagnetic compatibility) UN Regulation No 10 A A A A A A A A A A A A D3 Protection against unauthorised use, immobiliser and alarm systems UN Regulation No 18 UN Regulation No 97 UN Regulation No 116 A A (1) A (1) A A (1) A (1) A A D4 Protection of vehicle against cyberattacks B B B B B B B B D5 Speedometer UN Regulation No 39 A A A A A A D6 Odometer UN Regulation No 39 A A A A A A D7 Speed limitation devices UN Regulation No 89 A A A A A D8 Intelligent speed assistance B B B B B B B D9 Identification of controls, tell-tales and indicators UN Regulation No 121 A A A A A A D10 Heating systems UN Regulation No 122 A A A A A A A A A A A D11 Light signalling devices UN Regulation No 4 UN Regulation No 6 UN Regulation No 7 UN Regulation No 19 UN Regulation No 23 UN Regulation No 38 UN Regulation No 77 UN Regulation No 87 UN Regulation No 91 X X X X X X X X X X A D12 Road illumination devices UN Regulation No 31 UN Regulation No 98 UN Regulation No 112 UN Regulation No 119 UN Regulation No 123 X X X X X X A D13 Retro-reflective devices UN Regulation No 3 UN Regulation No 104 X X X X X X X X X X A D14 Light sources UN Regulation No 37 UN Regulation No 99 UN Regulation No 128 X X X X X X X X X X A D15 Installation of light signalling, road illumination and retro‐reflective devices UN Regulation No 48 A A A A A A A A A A D16 Emergency Stop Signal B B B B B B D17 Headlamp cleaners UN Regulation No 45 A (1) A (1) A (1) A (1) A (1) A (1) A D18 Gear shift indicator A Requirements concerning E DRIVER AND SYSTEM BEHAVIOUR E1 Alcohol interlock installation facilitation EN 50436:2016 B B B B B B E2 Driver drowsiness and attention warning B B B B B B E3 Advanced driver distraction warning Distraction avoidance by technical means may also be taken into consideration C C C C C C E4 Driver availability monitoring system B (5) B (5) B (5) B (5) B (5) B (5) E5 Event data recorder B D D B D D B E6 Systems to replace driver’s control B (5) B (5) B (5) B (5) B (5) B (5) E7 Systems to provide the vehicle with information on state of vehicle and surrounding area B (5) B (5) B (5) B (5) B (5) B (5) E8 Platooning B (1) B (1) B (1) B (1) E9 Systems to provide safety information to other road users B (5) B (5) B (5) B (5) B (5) B (5) Requirements concerning F GENERAL VEHICLE CONSTRUCTION AND FEATURES F1 Registration plate space A A A A A A A A A A F2 Reversing motion A A A A A A F3 Door latches and hinges UN Regulation No 11 A A F4 Door entry steps, handholds and running boards A A A A F5 External projections UN Regulation No 26 A F6 External projections of commercial vehicle cabs UN Regulation No 61 A A A F7 Statutory plate and vehicle identification number A A A A A A A A A A F8 Towing devices A A A A A A F9 Wheel guards A F10 Spray suppression systems A A A A A A A F11 Masses and dimensions A A A A A A A A A A F12 Mechanical couplings UN Regulation No 55 UN Regulation No 102 A (1) A (1) A (1) A (1) A (1) A (1) A A A A A A F13 Vehicles intended for the transportation of dangerous goods UN Regulation No 105 A A A A A A A F14 General bus construction UN Regulation No 107 A A F15 Bus strength of superstructure UN Regulation No 66 A A F16 Flammability in buses UN Regulation No 118 A A Notes to the table A: Date for the prohibition of the registration of vehicles, as well as the placing on the market and entry into service of components and separate technical units: 6 July 2022 B: Date for refusal to grant EU type-approval: 6 July 2022 Date for the prohibition of the registration of vehicles, as well as the placing on the market and entry into service of components and separate technical units: 7 July 2024 C: Date for refusal to grant EU type-approval: 7 July 2024 Date for the prohibition of the registration of vehicles, as well as the placing on the market and entry into service of components and separate technical units: 7 July 2026 D: Date for refusal to grant EU type-approval: 7 January 2026 Date for the prohibition of the registration of vehicles, as well as the placing on the market and entry into service of components and separate technical units: 7 January 2029 X: The component or separate technical unit in question applies to the vehicle categories as indicated. (1) Compliance is required if fitted. (2) Vehicles of this category shall be fitted with an adequate windscreen defrosting and demisting device. (3) Vehicles of this category shall be fitted with adequate windscreen washing and wiping devices. (4) The following vehicles are exempted: — semi-trailer towing vehicles of category N2 with a maximum mass exceeding 3,5 tonnes but not exceeding 8 tonnes, — vehicles of categories M2 and M3 of Class A, Class I and Class II as defined in paragraph 2.1 of UN Regulation No 107, — articulated buses of category M3 of Class A, Class I and Class II as defined in paragraph 2.1 of UN Regulation No 107, — off-road vehicles of categories M2, M3, N2 and N3, — special purpose vehicles of categories M2, M3, N2 and N3, and — vehicles of categories M2, M3, N2 and N3 with more than three axles. (5) Compliance is required in case of automated vehicles. (6) For motor vehicles with hydraulic power assisted steering systems dates in Note C apply. Those vehicles, however, shall be equipped with a lane departure warning system instead. ANNEX III Amendments to Annex II to Regulation (EU) 2018/858 Annex II to Regulation (EU) 2018/858 is amended as follows: (1) references to ‘Regulation (EC) No 661/2009’ are amended as follows: (a) in the table in Part I, in the entry for item 3A, the reference in the third column to ‘Regulation (EC) No 661/2009’ is replaced by the following: ‘Regulation (EU) 2019/2144 of the European Parliament and of the Council (*1) (*1) Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1)’;" (b) each subsequent reference to ‘Regulation (EC) No 661/2009’ throughout Annex II is replaced by a reference to ‘Regulation (EU) 2019/2144’; (2) Part I is amended as follows: (a) the table is amended as follows: (i) the following entry is inserted after the entry for item 54A: ‘55A Pole side impact Regulation (EU) 2019/2144 UN Regulation No 135 X X’; (ii) the entry for item 58 is replaced by the following: ‘58 Pedestrian protection Regulation (EU) 2019/2144 UN Regulation No 127 X X X’; (iii) the entries for items 62 and 63 are replaced by the following: ‘62 Hydrogen system Regulation (EU) 2019/2144 UN Regulation No 134 X X X X X X X 63 General safety Regulation (EU) 2019/2144 X(15) X(15) X(15) X(15) X(15) X(15) X(15) X(15) X(15) X(15) X(15)’; (iv) the entries for items 65 and 66 are replaced by the following: ‘65 Advanced emergency braking system Regulation (EU) 2019/2144 UN Regulation No 131 X X X X 66 Lane departure warning system Regulation (EU) 2019/2144 UN Regulation No 130 X X X X’; (b) the explanatory notes are amended as follows: (i) explanatory notes 3 and 4 are replaced by the following: ‘(3) The fitting of vehicle stability function is required in accordance with Article 4(5) of Regulation (EU) 2019/2144. (4) The fitting of an electronic stability control system is required in accordance with Article 4(5) of Regulation (EU) 2019/2144.’; (ii) explanatory note 9A is replaced by the following: ‘(9A) The fitting of a tyre pressure monitoring system is required in accordance with Article 5(1) of Regulation (EU) 2019/2144.’; (iii) explanatory note 15 is replaced by the following: ‘(15) Compliance with Regulation (EU) 2019/2144 is mandatory. However, type-approval under this specific item is not envisaged as it merely represents the collection of individual items listed elsewhere in the table that make reference to Regulation (EU) 2019/2144.’; (c) in Appendix 1, Table 1 is amended as follows: (i) the entry for item 46A is replaced by the following: ‘46A Installation of tyres Regulation (EU) 2019/2144 UN Regulation No 142 B’; (ii) the entry for item 58 is replaced by the following: ‘58 Pedestrian protection Regulation (EU) 2019/2144 UN Regulation No 127 C Date for refusal to grant EU type‐approval: 7 January 2026 Date for the prohibition of the registration of vehicles: 7 July 2034’; (iii) the entries for items 62 and 63 are replaced by the following: ‘62 Hydrogen system Regulation (EU) 2019/2144 UN Regulation No 134 X 63 General safety Regulation (EU) 2019/2144 Compliance with Regulation (EU) 2019/2144 is mandatory. However, type-approval under this specific item is not envisaged as it merely represents the collection of individual items listed elsewhere in the table that make reference to Regulation (EU) 2019/2144.’; (d) the explanatory note NA to Table 1 of Appendix 1 is replaced by the following: ‘N/A The regulatory act shall not apply. Compliance with one or more specific aspects included in the regulatory act may however be imposed.’; (e) in Appendix 1, Table 2 is amended as follows: (i) the entry for item 46A is replaced by the following: ‘46A Installation of tyres Regulation (EU) 2019/2144 UN Regulation No 142 B’; (ii) the entry for item 58 is replaced by the following: ‘58 Pedestrian protection Regulation (EU) 2019/2144 UN Regulation No 127 C Date for refusal to grant EU type‐approval: 7 January 2026 Date for the prohibition of the registration of vehicles: 7 July 2034’; (iii) the entries for items 62 and 63 are replaced by the following: ‘62 Hydrogen system Regulation (EU) 2019/2144 UN Regulation No 134 X 63 General safety Regulation (EU) 2019/2144 Compliance with Regulation (EU) 2019/2144 is mandatory. However, type-approval under this specific item is not envisaged as it merely represents the collection of individual items listed elsewhere in the table that make reference to Regulation (EU) 2019/2144.’; (f) in Appendix 2, point 4 is amended as follows: (i) the table ‘Part I: Vehicles belonging to category M1’ is amended as follows: — the entry for item 58 is replaced by the following: ‘58 UN Regulation No 127 Regulation (EU) 2019/2144 (Pedestrian protection) Vehicles shall be fitted with an electronic antilock braking system acting on all wheels. The requirements of UN Regulation No 127 shall apply. Any frontal protection system shall either be an integral part of the vehicle and thus compliant with the requirements of UN Regulation No 127 or be type‐approved as separate technical unit.’; — the following entry is inserted after the entry for item 61: ‘62 UN Regulation No 134 Regulation (EU) 2019/2144 (Hydrogen system) The requirements of UN Regulation No 134 shall apply. Alternatively, it shall be demonstrated that the vehicle complies with: — Substantive requirements of Regulation (EC) No 79/2009 in its version applicable on 5 July 2022; — Attachment 100 – Technical Standard For Fuel Systems Of Motor Vehicle Fueled By Compressed Hydrogen Gas (Japan); — GB/T 24549-2009 Fuel cell electric vehicles – safety requirements (China); — International standard ISO 23273:2013 Part 1: Vehicle functional safety and Part 2: Protection against hydrogen hazards for vehicles fuelled with compressed hydrogen; or — SAE J2578 – General Fuel Cell Vehicle Safety’; (ii) the table ‘Part II Vehicles belonging to category N1’ is amended as follows: — the entry for item 58 is replaced by the following: ‘58 UN Regulation No 127 Regulation (EU) 2019/2144 (Pedestrian protection) Vehicles shall be fitted with an electronic antilock braking system acting on all wheels. The requirements of UN Regulation No 127 shall apply. Any frontal protection system shall either be an integral part of the vehicle and thus compliant with the requirements of UN Regulation No 127 or be type‐approved as separate technical unit’; — the following entry is inserted after the entry for item 61: ‘62 UN Regulation No 134 Regulation (EU) 2019/2144 (Hydrogen system) The requirements of UN Regulation No 134 shall apply. Alternatively, it shall be demonstrated that the vehicle complies with: — Substantive requirements of Regulation (EC) No 79/2009 in its version applicable on 5 July 2022; — Attachment 100 – Technical Standard For Fuel Systems Of Motor Vehicle Fueled By Compressed Hydrogen Gas (Japan); — GB/T 24549-2009 Fuel cell electric vehicles – safety requirements (China); — International standard ISO 23273:2013 Part 1: Vehicle functional safety and Part 2: Protection against hydrogen hazards for vehicles fuelled with compressed hydrogen; or — SAE J2578 – General Fuel Cell Vehicle Safety’; (3) in Part II, in the table, the entries for items 58, 65 and 66 are deleted; (4) Part III is amended as follows: (a) in Appendix 1, the table is amended as follows: (i) the entry for item 58 is replaced by the following: ‘58 Pedestrian protection Regulation (EU) 2019/2144 UN Regulation No 127 X X’; (ii) the entries for items 62 and 63 are replaced by the following: ‘62 Hydrogen system Regulation (EU) 2019/2144 UN Regulation No 134 X X X X 63 General safety Regulation (EU) 2019/2144 X(15) X(15) X(15) X(15)’; (iii) the entries for items 65 and 66 are replaced by the following: ‘65 Advanced emergency braking system Regulation (EU) 2019/2144 UN Regulation No 131 N/A N/A 66 Lane departure warning system Regulation (EU) 2019/2144 UN Regulation No 130 N/A N/A’; (b) in Appendix 2, the table is amended as follows: (i) the following entry is inserted after the entry for item 54A: ‘55A Pole side impact Regulation (EU) 2019/2144 UN Regulation No 135 N/A N/A’; (ii) the entry for item 58 is replaced by the following: ‘58 Pedestrian protection Regulation (EU) 2019/2144 UN Regulation No 127 N/A N/A’; (iii) the entries for items 62 and 63 are replaced by the following: ‘62 Hydrogen system Regulation (EU) 2019/2144 UN Regulation No 134 X X X X X X 63 General safety Regulation (EU) 2019/2144 X(15) X(15) X(15) X(15) X(15) X(15) X(15) X(15) X(15) X(15)’; (iv) the entries for items 65 and 66 are replaced by the following: ‘65 Advanced emergency braking system Regulation (EU) 2019/2144 UN Regulation No 131 N/A N/A N/A N/A 66 Lane departure warning system Regulation (EU) 2019/2144 UN Regulation No 130 N/A N/A N/A N/A’; (c) Appendix 3 is amended as follows: (i) in the table, the following entry is inserted after the entry for item 54A: ‘55A Pole side impact Regulation (EU) 2019/2144 UN Regulation No 135 N/A’; (ii) in the table, the entry for item 58 is replaced by the following: ‘58 Pedestrian protection Regulation (EU) 2019/2144 UN Regulation No 127 G’; (iii) in the table, the entries for items 62 and 63 are replaced by the following: ‘62 Hydrogen system Regulation (EU) 2019/2144 UN Regulation No 134 X 63 General safety Regulation (EU) 2019/2144 X(15)’; (iv) the following point is added: ‘5. Points 1 to 4 also apply to vehicles of category M1 that are not categorised as special purpose vehicles but are wheelchair accessible vehicles.’; (d) in Appendix 4, the table is amended as follows: (i) the following entry is inserted after the entry for item 54A: ‘55A Pole side impact Regulation (EU) 2019/2144 UN Regulation No 135 A’; (ii) the entry for item 58 is replaced by the following: ‘58 Pedestrian protection Regulation (EU) 2019/2144 UN Regulation No 127 A’; (iii) the entries for items 62, 63, 65 and 66 are replaced by the following: ‘62 Hydrogen system Regulation (EU) 2019/2144 UN Regulation No 134 X X X X X 63 General safety Regulation (EU) 2019/2144 X(15) X(15) X(15) X(15) X(15) X(15) X(15) X(15) X(15) 65 Advanced emergency braking system Regulation (EU) 2019/2144 UN Regulation No 131 N/A N/A N/A N/A 66 Lane departure warning system Regulation (EU) 2019/2144 UN Regulation No 130 N/A N/A N/A N/A’; (e) in Appendix 5, in the table, the entries for items 62, 63, 65 and 66 are replaced by the following: ‘62 Hydrogen system Regulation (EU) 2019/2144 UN Regulation No 134 X 63 General safety Regulation (EU) 2019/2144 X(15) 65 Advanced emergency braking system Regulation (EU) 2019/2144 UN Regulation No 131 N/A 66 Lane departure warning system Regulation (EU) 2019/2144 UN Regulation No 130 N/A’; (f) in Appendix 6, in the table, the entries for items 62, 63, 65 and 66 are replaced by the following: ‘62 Hydrogen system Regulation (EU) 2019/2144 UN Regulation No 134 X 63 General safety Regulation (EU) 2019/2144 X(15) X(15) 65 Advanced emergency braking system Regulation (EU) 2019/2144 UN Regulation No 131 N/A 66 Lane departure warning system Regulation (EU) 2019/2144 UN Regulation No 130 N/A’; (g) the Explanatory Notes are amended as follows: (i) the explanatory note for X is replaced by the following: ‘X The requirements set out in the relevant regulatory act are applicable.’; (ii) explanatory notes 3 and 4 are replaced by the following: ‘(3) The fitting of vehicle stability function is required in accordance with Article 4(5) of Regulation (EU) 2019/2144. (4) The fitting of an electronic stability control system is required in accordance with Article 4(5) of Regulation (EU) 2019/2144’; (iii) explanatory note 9A is replaced by the following: ‘(9A) Applies only if vehicles are fitted with equipment covered by UN Regulation No 64. However, tyre pressure monitoring system is compulsory in accordance with Article 5(1) of Regulation (EU) 2019/2144’; (iv) explanatory note 15 is replaced by the following: ‘(15) Compliance with Regulation (EU) 2019/2144 is mandatory. However, type-approval under this specific item is not envisaged as it merely represents the collection of individual items listed elsewhere in the relevant table.’; (v) explanatory notes 16 and 17 are deleted. (*1) Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1)’;’ ANNEX IV Transitional provisions referred to in Article 15(3) UN Regulation Number Specific requirements Final date for registration of non-compliant vehicles as well as sale or entry into service of non-compliant components (1) 117 Tyres with regard to rolling sound emissions, adhesion on wet surfaces and rolling resistance 30 April 2023 Tyres of class C3 shall comply with Stage 2 rolling resistance requirements Notes to the table (1) The dates as laid down in Regulation (EC) No 661/2009 in respect of types of vehicle, system and component complying with the requirements in its version applicable on 5 July 2022 and Regulation (EC) No 78/2009 in respect of types of vehicle and system complying with the requirements in its version applicable on 5 July 2022.

Type-approval requirements to ensure the general safety of vehicles and the protection of vulnerable road users Type-approval requirements to ensure the general safety of vehicles and the protection of vulnerable road users SUMMARY OF: Regulation (EU) 2019/2144 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users WHAT IS THE AIM OF THE REGULATION? It aims to significantly reduce deaths and serious injuries on European Union (EU) roads by introducing state-of-the-art safety technologies as standard vehicle equipment, and to enhance the competitiveness of EU car manufacturers on the global market by providing the first ever EU legal framework for automated and fully automated vehicles. It amends Regulation (EU) 2018/858 on EU approval and market surveillance measures for motor vehicles and their trailers (see summary). KEY POINTS This new general safety regulation updates EU vehicle safety requirements, including those that address the specific concerns of vulnerable road users, such as pedestrians and cyclists. Advanced vehicle systems All new vehicles must be equipped with the following safety features: intelligent speed assistance; an interface to enable the fitting of an alcohol interlock (breathalyser); driver drowsiness and attention warning systems; advanced driver distraction warning systems; emergency stop signals; reversing detection systems; event data recorders; accurate tyre pressure monitoring. Cars and vans must be equipped with further advanced safety measures including: advanced emergency braking systems capable of detecting motor vehicles and vulnerable road users in front of them; emergency lane-keeping systems; enlarged head impact protection zones capable of mitigating injuries in collisions with vulnerable road users. Buses and lorries, in addition to meeting the general requirements and being equipped with existing systems (such as lane departure warning and advanced emergency braking systems), must also: be equipped with advanced systems capable of detecting pedestrians and cyclists in close proximity to the nearside of the vehicle, warning drivers of their presence and avoiding a collision with these vulnerable road users; be constructed in such a way that will help to reduce blind spots in front of and to the side of the driver. The regulation allows the European Commission to adopt specific implementing acts for the safety of hydrogen-powered and automated vehicles in the light of future technical developments. Review The Commission must present an evaluation report on the effectiveness of the safety measures and systems by 7 July 2027. If appropriate, the report must make recommendations and include a proposal for legislation to further reduce or eliminate road transport accidents and injuries. A further report should be presented every 5 years subsequently. Implementing and delegated acts The Commission has adopted: two implementing acts: Implementing Regulation (EU) 2021/535 on uniform procedures and technical specifications for the type-approval of vehicles, and of systems, components and separate technical units intended for such vehicles, as regards their general construction characteristics and safety,Implementing Regulation (EU) 2021/646 on uniform procedures and technical specifications for the type-approval of motor vehicles with regard to their emergency lane-keeping systems; and three delegated acts:Delegated Regulation (EU) 2021/1243 with detailed rules concerning the alcohol interlock installation facilitation in motor vehicles and amending Annex II to that regulation,Delegated Regulation (EU) 2021/1341 laying down detailed rules concerning the specific test procedures and technical requirements with regard to vehicle drivers' drowsiness and attention warning systems,Delegated Regulation (EU) 2021/1958 supplementing Regulation (EU) 2019/2144 with detailed rules on the specific test procedures and technical requirements for the type-approval of motor vehicles with regard to their intelligent speed assistance systems and for the type-approval of those systems as separate technical units. All these regulations also amend Annex II to Regulation (EU) 2019/2144. Repeal The regulation repeals Regulations (EC) No 78/2009, (EC) No 79/2009, (EC) No 661/2009, (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 with effect from 6 July 2022. FROM WHEN DOES THE REGULATION APPLY? It applies from 6 July 2022. BACKGROUND The regulation forms part of the Commission’s third Europe on the move package, designed to ensure a smooth transition towards a safe, clean and automated mobility system. The package includes the following. New EU type-approval rules for safer and cleaner cars: frequently asked questions (European Commission) Testing of emissions from cars (European Commission) Air quality: Commission takes action to protect citizens from air pollution (European Commission) EU action to curb air pollution by cars: questions and answers (European Commission). MAIN DOCUMENT Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, pp. 1–40). RELATED DOCUMENTS Commission Delegated Regulation (EU) 2021/1958 of 23 June 2021 supplementing Regulation (EU) 2019/2144 of the European Parliament and of the Council by laying down detailed rules concerning the specific test procedures and technical requirements for the type-approval of motor vehicles with regard to their intelligent speed assistance systems and for the type-approval of those systems as separate technical units and amending Annex II to that Regulation (OJ L 409, 17.11.2021, pp. 1–161). Commission Delegated Regulation (EU) 2021/1341 of 23 April 2021 supplementing Regulation (EU) 2019/2144 of the European Parliament and of the Council by laying down detailed rules concerning the specific test procedures and technical requirements for the type-approval of motor vehicles with regard to their driver drowsiness and attention warning systems and amending Annex II to that Regulation (OJ L 292, 16.8.2021, pp. 4–19). Commission Delegated Regulation (EU) 2021/1243 of 19 April 2021 supplementing Regulation (EU) 2019/2144 of the European Parliament and of the Council by laying down detailed rules concerning the alcohol interlock installation facilitation in motor vehicles and amending Annex II to that Regulation (OJ L 272, 30.7.2021, pp. 11–15). Commission Implementing Regulation (EU) 2021/646 of 19 April 2021 laying down rules for the application of Regulation (EU) 2019/2144 of the European Parliament and of the Council as regards uniform procedures and technical specifications for the type-approval of motor vehicles with regard to their emergency lane-keeping systems (OJ L 133, 20.4.2021, pp. 31–53). Successive amendments to Regulation (EU) 2021/646 have been incorporated in the original text. This consolidated version is of documentary value only. Commission Implementing Regulation (EU) 2021/535 of 31 March 2021 laying down rules for the application of Regulation (EU) 2019/2144 of the European Parliament and of the Council as regards uniform procedures and technical specifications for the type-approval of vehicles, and of systems, components and separate technical units intended for such vehicles, as regards their general construction characteristics and safety (OJ L 117, 6.4.2021, pp. 1–207). Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, pp. 101–218). See consolidated version. Commission Regulation (EU) 2015/166 of 3 February 2015 supplementing and amending Regulation (EC) No 661/2009 of the European Parliament and of the Council as regards the inclusion of specific procedures, assessment methods and technical requirements, and amending Directive 2007/46/EC of the European Parliament and of the Council, and Commission Regulations (EU) No 1003/2010, (EU) No 109/2011 and (EU) No 458/2011 (OJ L 28, 4.2.2015, pp. 3–39). Commission Regulation (EU) No 1230/2012 of 12 December 2012 implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council with regard to type-approval requirements for masses and dimensions of motor vehicles and their trailers and amending Directive 2007/46/EC of the European Parliament and of the Council (OJ L 353, 21.12.2012, pp. 31–79). See consolidated version. Commission Regulation (EU) No 351/2012 of 23 April 2012 implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council as regards type-approval requirements for the installation of lane departure warning systems in motor vehicles (OJ L 110, 24.4.2012, pp. 18–30). See consolidated version. Commission Regulation (EU) No 347/2012 of 16 April 2012 implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council with respect to type-approval requirements for certain categories of motor vehicles with regard to advanced emergency braking systems (OJ L 109, 21.4.2012, pp. 1–17). See consolidated version. Commission Regulation (EU) No 130/2012 of 15 February 2012 concerning type-approval requirements for motor vehicles with regard to vehicle access and manoeuvrability and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 43, 16.2.2012, pp. 6–14). Commission Regulation (EU) No 65/2012 of 24 January 2012 implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council as regards gear shift indicators and amending Directive 2007/46/EC of the European Parliament and of the Council (OJ L 28, 31.1.2012, pp. 24–38). Commission Regulation (EU) No 458/2011 of 12 May 2011 concerning type-approval requirements for motor vehicles and their trailers with regard to the installation of their tyres and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 124, 13.5.2011, pp. 11–20). See consolidated version. Commission Regulation (EU) No 109/2011 of 27 January 2011 implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council as regards type-approval requirements for certain categories of motor vehicles and their trailers as regards spray suppression systems (OJ L 34, 9.2.2011, pp. 2–28). See consolidated version. Commission Regulation (EU) No 19/2011 of 11 January 2011 concerning type-approval requirements for the manufacturer’s statutory plate and for the vehicle identification number of motor vehicles and their trailers and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 8, 12.1.2011, pp. 1–13). See consolidated version. Commission Regulation (EU) No 1009/2010 of 9 November 2010 concerning type-approval requirements for wheel guards of certain motor vehicles and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 292, 10.11.2010, pp. 21–29). Commission Regulation (EU) No 1008/2010 of 9 November 2010 concerning type-approval requirements for windscreen wiper and washer systems of certain motor vehicles and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 292, 10.11.2010, pp. 2–20). See consolidated version. Commission Regulation (EU) No 1005/2010 of 8 November 2010 concerning type-approval requirements for motor vehicle towing devices and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 291, 9.11.2010, pp. 36–42). Commission Regulation (EU) No 1003/2010 of 8 November 2010 concerning type-approval requirements for the space for mounting and the fixing of rear registration plates on motor vehicles and their trailers and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 291, 9.11.2010, pp. 22–30). See consolidated version. Commission Regulation (EU) No 672/2010 of 27 July 2010 concerning type-approval requirements for windscreen defrosting and demisting systems of certain motor vehicles and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 196, 28.7.2010, pp. 5–20). Commission Regulation (EU) No 406/2010 of 26 April 2010 implementing Regulation (EC) No 79/2009 of the European Parliament and of the Council on type-approval of hydrogen-powered motor vehicles (OJ L 122, 18.5.2010, pp. 1–107). See consolidated version. Commission Regulation (EC) No 631/2009 of 22 July 2009 laying down detailed rules for the implementation of Annex I to Regulation (EC) No 78/2009 of the European Parliament and of the Council on the type-approval of motor vehicles with regard to the protection of pedestrians and other vulnerable road users, amending Directive 2007/46/EC and repealing Directives 2003/102/EC and 2005/66/EC (OJ L 195, 25.7.2009, pp. 1–60). See consolidated version. Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, pp. 1–24). See consolidated version. last update 20.02.2022

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19.7.2021 EN Official Journal of the European Union L 256/3 COUNCIL REGULATION (EU) 2021/1173 of 13 July 2021 on establishing the European High Performance Computing Joint Undertaking and repealing Regulation (EU) 2018/1488 THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 187 and the first paragraph of Article 188 thereof, Having regard to the proposal from the European Commission, Having regard to the opinion of the European Parliament (1), Having regard to the opinion of the European Economic and Social Committee (2), Whereas: (1) Regulation (EU) 2021/695 of the European Parliament and of the Council (3) establishes Horizon Europe – the Framework Programme for Research and Innovation (‘Horizon Europe’). Parts of Horizon Europe may be implemented through European Partnerships, with private and/or public sector partners, in order to achieve the greatest possible impact of Union funding and the most effective contribution to the Union’s policy objectives. (2) In accordance with Regulation (EU) 2021/695 support may be provided to Joint Undertakings established in the framework of Horizon Europe. Such partnerships should be implemented only where other parts of Horizon Europe, including other forms of European Partnerships, would not achieve its objectives or would not generate the necessary expected impacts, and if justified by a long-term perspective and high degree of integration. The conditions under which such partnerships are created are specified in that Regulation. (3) Regulation (EU) 2021/694 of the European Parliament and of the Council (4) establishes the Digital Europe Programme. The Digital Europe Programme supports the implementation of projects of common interest which aim at the acquisition, deployment and operation of a world-class supercomputing, quantum and data infrastructure, at federation and interconnection, and at widening the use of supercomputing services and the development of key skills. (4) Regulation (EU) 2021/1153 of the European Parliament and of the Council (5) establishes the Connecting Europe Facility. The Connecting Europe Facility enables projects of common interest to be prepared and implemented within the framework of the trans-European networks policy in the sectors of transport, telecommunications and energy. In particular, the Connecting Europe Facility supports the implementation of those projects of common interest which aim at the development and construction of new infrastructures and services, or at the upgrading of existing infrastructures and services, in the transport, telecommunications and energy sectors. The Connecting Europe Facility contributes to supporting digital connectivity infrastructures of common interest bringing significant spillover societal benefits. (5) The Communication from the Commission of 19 February 2020 entitled ‘A European Strategy for Data’ outlines Europe’s strategy for policy measures and investments to enable the data economy for the coming five years. It emphasises the creation of European public common data spaces that will boost growth and create value. Support for the creation of such common European data spaces and federated, secure cloud infrastructures would ensure that more data becomes available for use in the economy and society, while keeping companies and individuals who generate the data in control. High Performance Computing and quantum computing are essential components of the seamless provision of computing resources with different performance characteristics required to maximise the growth and exploitation of European public common data spaces and federated, secure cloud infrastructures for public, industrial and scientific applications. (6) The Communication from the Commission of 19 February 2020 entitled ‘Shaping Europe’s digital future’ presents Europe’s digital strategy and focuses on key objectives to ensure that digital solutions help Europe to pursue its own way towards a digital transformation that works for the benefit of people. Among the key actions it proposes is investing in building and deploying cutting-edge joint digital capacities, including in supercomputing and quantum technologies, and expanding Europe’s supercomputing capacity to develop innovative solutions for medicine, transport and the environment. (7) The Communication from the Commission of 10 March 2020 entitled ‘A new Industrial Strategy for Europe’ reflects an ambitious industrial strategy for Europe to lead the twin transitions towards climate neutrality and digital leadership. The Communication stresses the support, among others, to the development of key enabling technologies that are strategically important for Europe’s industrial future, including High Performance Computing and quantum technologies. (8) The Communication from the Commission of 27 May 2020 entitled ‘Europe’s moment: Repair and Prepare for the Next Generation’ identified a number of strategic digital capacities and capabilities that included High Performance Computers and quantum technologies as a priority in the Recovery and Resilience Facility, InvestEU and the Strategic Investment Facility. (9) Europe’s leading role in the data economy, its scientific excellence, and its industrial strength increasingly depend on its ability to develop key High Performance Computing technologies, to provide access to world-class supercomputing and data infrastructures, and to maintain its present leadership in High Performance Computing applications. High Performance Computing is a mainstream technology for the digital transformation of the European economy, enabling many traditional industrial sectors to innovate with higher value products and services. In combination with other advanced digital technologies such as artificial intelligence, big data and cloud technologies, High Performance Computing is paving the way towards innovative societal and industrial applications in critical areas for Europe such as personalised medicine, weather forecast and climate change, smart and green development and transport, new materials for clean energy, drug design and virtual testing, sustainable agriculture, or engineering and manufacturing. (10) High Performance Computing is a strategic resource for policy making, powering applications that provide the means to understand and design efficient solutions to address many complex global challenges and for crisis management. High Performance Computing contributes to key policies such as the European Green Deal with models and tools for transforming the increasing number of complex environmental challenges into opportunities for social innovation and economic growth. An example is the Destination Earth initiative announced in the Communications from the Commission of 11 December 2019 entitled ‘The European Green Deal’, and of 19 February 2020 entitled ‘A European strategy for data’ and ‘Shaping Europe’s digital future’. (11) Global events such as the COVID-19 pandemic have shown the importance of investing in High Performance Computing and health-related modelling platforms and tools, as they are playing a key role in the fight against the pandemic, often in combination with other digital technologies such as big data and artificial intelligence. High Performance Computing is being used to accelerate the identification and production of treatments, including vaccines, to predict the virus’ spread, to help plan the distribution of medical supplies and resources, and to simulate post-epidemic exit measures in order to evaluate different scenarios. High Performance Computing modelling platforms and tools are critical tools for the current and future pandemics, and they will play a key role in health and personalised medicine. (12) Council Regulation (EU) 2018/1488 (6) established the European High Performance Computing Joint Undertaking (‘EuroHPC Joint Undertaking’) with a mission to develop, deploy, extend and maintain in the Union an integrated world-class supercomputing and data infrastructure and to develop and support a highly competitive and innovative High Performance Computing ecosystem. (13) In light of developments in High Performance Computing, a revision of Regulation (EU) 2018/1488 to ensure the continuation of the initiative is necessary in order to define a new mission and objectives for the EuroHPC Joint Undertaking, taking into consideration the analysis of the key socioeconomic and technological drivers affecting the future evolution of High Performance Computing and data infrastructures, technologies and applications in the Union and worldwide, and the lessons learnt from the current activities of the EuroHPC Joint Undertaking. The revision would also allow for the alignment of the EuroHPC Joint Undertaking’s rules with the new legal framework, in particular Regulation (EU) 2021/695, as well as Regulations (EU) 2021/694 and (EU) 2021/1153. (14) In order to equip the Union with the computing performance needed to maintain its research and industrial capacities at a leading edge, Member States’ investment in High Performance Computing and quantum computing should be coordinated and the industrial and market take-up of High Performance Computing and quantum computing technologies be reinforced both in the public and private sectors. The Union should increase its effectiveness in turning the technology developments into demand-oriented and application-driven European High Performance Computing and quantum computing systems of the highest quality, establishing an effective link between technology supply, co-design with users, and a joint procurement of world-class systems, and creating a world-class ecosystem in High Performance Computing and quantum computing technologies and applications across Europe. At the same time, the Union should provide an opportunity for its supply industry to leverage on such investments, leading to their uptake in large-scale and emerging application fields such as personalised medicine, climate change, connected and automated driving or other lead markets that are underpinned by artificial intelligence, blockchain technologies, edge computing or more broadly by the digitalisation of the European industry. (15) In order for the Union and its Member States to achieve leadership in key digital technologies such as High Performance Computing and quantum computing, they should invest in next generation low-power and energy efficient supercomputing technologies, innovative software and advanced supercomputing systems for exascale and post-exascale computing and quantum computing, and for innovative supercomputing and data applications. This should allow the European supply industry to thrive in a wide range of key technology and application areas that reach beyond High Performance Computing and quantum computing and, in the long run, feed broader ICT markets with such technologies. It would also support the High Performance Computing and quantum computing science and user industry to undergo a digital transformation and boost its innovation potential. (16) Pursuing a common strategic Union vision in High Performance Computing and quantum computing is essential for realising the ambition of the Union and of its Member States to ensure a leading role in the digital economy. The objective would be to establish in Europe a world-leading hyper-connected, federated and secure High Performance Computing and quantum computing service and data infrastructure ecosystem, and to be in a position to produce innovative and competitive High Performance Computing and quantum computing systems based on a supply chain that is more resilient and will ensure the availability of components, technologies and knowledge, limiting the risk of disruptions. (17) A Joint Undertaking represents the best instrument capable of implementing the strategic EU vision in High Performance Computing and quantum computing, thus ensuring that the Union enjoys world-class supercomputing, quantum computing and data capabilities according to its economic potential, matching the needs of European users. The Joint Undertaking is the best instrument to overcome the present limitations, while offering the highest economic, societal, and environmental impact and best safeguarding the Union’s interests in High Performance Computing and quantum computing. It can pool resources from the Union, Member States and third countries associated to Horizon Europe, the Digital Europe Programme or the Connecting Europe Facility and the private sector. It can implement a procurement framework and operate world-class High Performance Computing and quantum computing systems. It can launch research and innovation programmes for developing European technologies and their subsequent integration in world-class supercomputing systems. (18) The Joint Undertaking will be part of the Institutionalised Partnerships portfolio under Horizon Europe which should strive to strengthen Union’s scientific capacities to deal with emerging threats and future challenges in a reinforced European Research Area, secure sustainability-driven Union’s value chains and Union’s strategic autonomy, and enhance the uptake of innovative solutions addressing climate, environmental, health and other global societal challenges in line with Union strategic priorities, including to reach climate neutrality in the Union by 2050. (19) The Joint Undertaking should be financed by the Union programmes under the multiannual financial framework for the years 2021 to 2027 (the ‘MFF 2021-2027’). It should be established in 2021 and operate until 31 December 2033 to equip the Union with a world-class federated, secure and hyper-connected supercomputing infrastructure, and to develop the necessary technologies, applications and skills for reaching exascale capabilities around 2022-2024, and post exascale around 2025 – 2027, while promoting a world-class European High Performance Computing and quantum computing innovation ecosystem. In accordance with Article 10(2)(c) of Regulation (EU) 2021/695, Joint Undertakings are to have a clear life cycle approach. In order to adequately protect the financial interests of the Union, the Joint Undertaking should be set up for a period ending 31 December 2033 to allow it to exercise its responsibilities with regard to grant implementation until the last indirect actions launched have been completed and with regard to finalising the activities related to the operation of the EuroHPC supercomputers. (20) The public-private partnership in the form of the Joint Undertaking should combine the financial and technical means that are essential to master the complexity of the ever escalating pace of innovation in this area. Therefore, the members of the Joint Undertaking should be the Union, Member States and third countries associated to Horizon Europe, the Digital Europe Programme or the Connecting Europe Facility agreeing on a joint European initiative in High Performance Computing and quantum computing, and associations representing their constituent entities and other organisations with an explicit and active engagement to produce research and innovation results, to develop and deploy high performance computing or quantum computing capabilities, or contributing to address the skills gap and keep the know-how in the field of High Performance Computing and quantum computing in Europe. The Joint Undertaking should be open to new members. (21) In accordance with Annex III to Regulation (EU) 2021/695, the financial contributions from members other than the Union should be at least equal to 50 % and should be able to reach up to 75 % of the aggregated Joint Undertaking budgetary commitments. Conversely, the Union contribution, including any additional funds from third countries associated to Horizon Europe, the Digital Europe Programme or the Connecting Europe Facility, should not exceed 50 % of the aggregated Joint Undertaking budgetary commitments. (22) The Union contribution should cover the administrative costs of the Joint Undertaking. (23) In accordance with point (c) of Article 10(1) of Regulation (EU) 2021/695, the Joint Undertaking is to implement a central management of all financial contributions through a coordinated approach. Accordingly, each Participating State should conclude one or more administrative agreements with the Joint Undertaking laying down the coordination mechanism for the payment of and reporting on contributions to applicants established in that Participating State. In order to ensure coherence with their national strategic priorities, Participating States should be provided with a right of veto over the use of their national financial contributions for applicants established in those Participating States. In order to minimise the administrative burden for beneficiaries, achieve simplification and ensure a more efficient implementation, each Participating State should strive to synchronise its payment schedule, reporting and audits with those of the Joint Undertaking and to converge its cost eligibility with Horizon Europe rules. Beneficiaries established in Participating States that entrusted the payment activities to the Joint Undertaking should sign a single grant agreement with the Joint Undertaking following Horizon Europe rules. (24) With a view to regaining a leading position in High Performance Computing technologies, and developing a full High Performance Computing and quantum computing ecosystem for the Union, in 2014, the industrial and research stakeholders in the European Technology Platform for High Performance Computing (ETP4HPC) Association established a contractual public private partnership with the Union. Its mission is to build a European world-class High Performance Computing technology value chain that would be globally competitive, fostering synergies between the three main components of the High Performance Computing ecosystem, namely technology development, applications and supercomputing infrastructure. Considering its expertise, and its role in bringing together the relevant private stakeholders in High Performance Computing, the ETP4HPC should be eligible for membership in the Joint Undertaking. (25) With a view to strengthening the data value chain, enhancing community building around data and setting the grounds for a thriving data-driven economy in the Union, in 2014, the industrial and research stakeholders in the Big Data Value Association (BDVA) established a contractual public private partnership with the Union. In 2020 BDVA changed its name to Data, AI and Robotics (DAIRO). Considering its expertise and its role in bringing together the relevant private stakeholders of big data, DAIRO should be eligible for membership in the Joint Undertaking. (26) The private associations ETP4HPC and DAIRO have expressed, in writing, their willingness to contribute to the Joint Undertaking’s multiannual strategic programme and bring their expertise into the realisation of the objectives of the Joint Undertaking. It is appropriate that those private associations accept the Statutes set out in the Annex to this Regulation by means of a letter of endorsement. (27) The Joint Undertaking should address clearly defined topics that would enable academia and European industries at large to design, develop and use the most innovative technologies in High Performance Computing and quantum computing, and to establish an integrated and federated, secure networked infrastructure across the Union with world-class High Performance Computing and quantum computing capability, high-speed connectivity and leading-edge applications and data and software services for its scientists and for other lead users from industry, including small and medium-sized enterprises (SMEs) and the public sector. The Joint Undertaking should aim at the development and use of top class technologies and infrastructures, addressing the demanding requirements of European scientific, industrial and public sector users. (28) The mission of the Joint Undertaking should be structured in one administrative pillar and six technical pillars addressing respectively the infrastructure activities, the activities federating the supercomputing services, the technology-related activities, the supercomputing applications related activities, the activities to widen the usage and skills, and the international cooperation activities. The Digital Europe Programme should be used to fund the infrastructure pillar, part of the federation of supercomputing services pillar and the widening usage and skills pillar. The Connecting Europe Facility should be used to fund the remaining activities of the federation of supercomputing services pillar, i.e. the interconnection of the High Performance Computing, quantum computing and data resources, as well as the interconnection with the Union’s common European data spaces and secure cloud infrastructures. Horizon Europe should be used to fund the technology pillar, the application pillar and the international cooperation pillar. (29) The Joint Undertaking should be able to cooperate with the Partnership for Advanced Computing in Europe (PRACE) for providing and managing access to a federated and interconnected supercomputing and data infrastructure and its services, as well as for training facilities and skills development opportunities. It should also be able to cooperate with the GÉANT network for the connectivity between the supercomputers of the Joint Undertaking, as well as with other European supercomputing and data infrastructures. (30) The Joint Undertaking should contribute to reducing the specific skills gap across the Union by engaging in awareness raising measures and assisting in the building of new knowledge and human capital. This includes the design and support of specific educational and training activities in close cooperation with the relevant public and private actors. (31) In line with the external policy objectives and international commitments of the Union, the Joint Undertaking should facilitate cooperation between the Union and international actors by defining a cooperation strategy, including identifying and promoting areas for cooperation in research and development and skills development and implementing actions where there is a mutual benefit, as well as ensuring an access policy of respective High Performance Computing and quantum computing capabilities and applications mainly based on reciprocity. (32) The Joint Undertaking should aim at promoting the exploitation of any resulting High Performance Computing technologies in the Union. It should also aim at safeguarding the investments in the supercomputers it acquires. In doing so, it should take appropriate measures to ensure the security of the supply chain of acquired technologies that should cover the whole lifetime of these supercomputers. (33) The Joint Undertaking should lay the ground for a longer-term vision and build the first hybrid High Performance Computing infrastructure in Europe, integrating classical computing architectures with quantum computing devices. Structured and coordinated financial support at European level is necessary to help research teams and European industries produce world-class results to ensure the fast and broad industrial exploitation of European research and technology across the Union, generating important spillovers for society, to share risk-taking and joining of forces by aligning strategies and investments towards a common European interest. (34) In order to achieve its objectives to design, develop and use the most innovative technologies in High Performance Computing and quantum computing, the Joint Undertaking should provide financial support in particular in the form of grants and procurement following open and competitive calls for proposals and calls for tenders based on annual work programmes. Such financial support should be targeted in particular at proven market failures that prevent the development of the programme concerned, should not crowd out private investments and should have an incentive effect in that it changes the behaviour of the recipient. (35) In order to achieve its objectives to increase the innovation potential of industry, and in particular of SMEs, to contribute to reducing the specific skills gap, to support the increase of knowledge and human capital and to upraise High Performance Computing and quantum computing capabilities, the Joint Undertaking should support the creation, and in particular the networking and coordination, of national High Performance Computing Competence Centres across Participating States. Those competence centres should provide High Performance Computing and quantum computing services to industry, academia and public administrations on their demand. They should primarily promote and enable access to the High Performance Computing innovation ecosystem, facilitate access to the supercomputers and quantum computers, address the significant shortages in skilled technical experts by undertaking awareness raising, training and outreach activities, and embark on networking activities with stakeholders and other national High Performance Computing Competence Centres to foster wider innovations, for example by exchanging and promoting best practice use cases or application experiences, by sharing their training facilities and experiences, by facilitating the co-development and exchange of parallel codes, or by supporting the sharing of innovative applications and tools for public and private users, in particular SMEs. (36) The Joint Undertaking should provide a demand-oriented and user-driven framework and enable a co-design approach for the acquisition of an integrated, world-class federated, secure and hyper-connected supercomputing and quantum computing service and data infrastructure in the Union, in order to equip users with the strategic computation resource they need to develop new, innovative solutions and to solve societal, environmental, economic and security challenges. For that purpose, the Joint Undertaking should contribute to the acquisition of world-class supercomputers. The supercomputers of the Joint Undertaking, including quantum computers, should be installed in a Participating State that is a Member State. (37) For a cost effective implementation of the Joint Undertaking’s mission to develop, deploy, extend and maintain in the Union a world-leading supercomputing ecosystem, the Joint Undertaking should seize the opportunity to upgrade the supercomputers it owns, where appropriate. Thus, the upgrades should lead to an extension of the supercomputers’ lifetime, increase the operational performance, and provide new functionalities to address the evolution of user needs. For the purpose of upgrading its supercomputers, the Joint Undertaking should be able to launch a call for expressions of interest as part of the infrastructure pillar. The calls for expression of interest should define the specific eligibility conditions that should apply to a hosting entity which is already hosting a EuroHPC supercomputer. (38) The Joint Undertaking should hyper-connect all the supercomputers and data infrastructures it owns or co-owns with state-of-the-art networking technologies, making them widely accessible across the Union, and should interconnect and federate its supercomputing and quantum computing data infrastructure, as well as national, regional and other computing infrastructures with a common platform. The Joint Undertaking should also ensure the interconnection of the federated, secure supercomputing, and quantum computing service and data infrastructures with the common European data spaces, including the European Open Science Cloud, and federated, secure cloud infrastructures announced in the Communication from the Commission of 19 February 2020 entitled ‘A European Strategy for Data’, for seamless service provisioning to a wide range of public and private users across Europe. (39) Horizon Europe and the Digital Europe Programme should, respectively, contribute to the closing of the research and innovation divide within the Union and to deploying wide-range supercomputing capabilities by promoting synergies with the European Regional Development Fund (ERDF), the European Social Fund+ (ESF+), the European Maritime, Fisheries and Aquaculture Fund (EMFAF) and the European Agricultural Fund for Rural Development (EAFRD), as well as the Recovery and Resilience Facility (RRF). Therefore, the Joint Undertaking should seek to develop close interactions with those funds which can specifically help to strengthen local, regional and national research and innovation capabilities. (40) The Joint Undertaking should provide a favourable framework for Participating States that are Member States to use financial contributions under the programmes co-financed by ERDF, ESF+, EMFAF and EAFRD for the acquisition of High Performance Computing and quantum computing and data infrastructures and their interconnection. The use of those financial contributions in the Joint Undertaking activities is essential for developing in the Union an integrated, federated, secure and hyper-connected world-class High Performance Computing, quantum computing service and data infrastructure, since the benefits for such infrastructure extend well beyond the users of the Member States. If Member States decide to use those financial contributions for the activities of the Joint Undertaking, those contributions should be considered as national contributions of the Participating States that are Member States to the budget of the Joint Undertaking, provided that Article 106 and other applicable provisions of Regulation (EU) 2021/1060 of the European Parliament and of the Council (7) and the fund-specific regulations are complied with. (41) The Joint Undertaking can facilitate the use of RRF funds by Participating States that are Member States. The RRF funds can complement the actions funded by the Joint Undertaking, provided that support under the RRF is additional to the support provided by the Union funds of the Joint Undertaking and that it does not cover the same cost. The use of RRF should not be accounted as national contribution to the budget of the Joint Undertaking, particularly in regard to High Performance Computing and quantum computing service and data infrastructures, as well as on technology, applications and skills development projects. (42) The Union’s contribution from the Digital Europe Programme funds should partly cover the acquisition costs of high-end supercomputers, quantum computers, industrial-grade supercomputers and mid-range supercomputers to align with the Joint Undertaking’s objective to contribute to the pooling of resources for equipping the Union with top-class supercomputers and quantum computers. The complementary costs of these supercomputers and quantum computers should be covered by the Participating States, the Private Members or consortia of private partners. The share of the Union’s access time to these supercomputers or quantum computers should be directly proportional to the financial contribution of the Union made for the acquisition of these supercomputers and quantum computers and should not exceed 50 % of the total access time of these supercomputers or quantum computers. (43) The Joint Undertaking should be the owner of the high-end supercomputers and quantum computers it has acquired. The operation of each high-end supercomputer or quantum computer should be entrusted to a hosting entity. The hosting entity should be able to represent a single Participating State that is a Member State or a hosting consortium of Participating States. The hosting entity should be able to provide an accurate estimate and to verify the operating costs of the supercomputer, by ensuring, for example, the functional separation, and to the extent possible, the physical separation of the Joint Undertaking’s high-end supercomputers or quantum computers and any national or regional computing systems it operates. The hosting entity should be selected by the Governing Board of the Joint Undertaking (the ‘Governing Board’) following a call for expression of interest evaluated by independent experts. Once a hosting entity is selected, the Participating State where the hosting entity is established or the hosting consortium should be able to decide to call for other Participating States to join and contribute to the funding of the high-end supercomputer or quantum computer to be installed in the selected hosting entity. If additional Participating States join the selected hosting consortium, this should be without prejudice to the Union’s access time to the supercomputers. The contributions of the Participating States in a hosting consortium to the supercomputer or quantum computer should be translated into shares of access time to that supercomputer or quantum computer. The Participating States should agree among themselves the distribution of their share of access time to the supercomputer or the quantum computer. (44) The Joint Undertaking should remain the owner of supercomputers or quantum computers it acquires until they are depreciated. The Joint Undertaking should be able to transfer this ownership to the hosting entity for decommissioning, disposal or any other use. When the ownership is transferred to the hosting entity or when the Joint Undertaking is being wound up, the hosting entity should reimburse the Joint Undertaking the residual value of the supercomputer or the quantum computer. (45) The Joint Undertaking should jointly with Participating States acquire the mid-range supercomputers. The operation of each mid-range supercomputer should be entrusted to a hosting entity. The hosting entity should be able to represent a single Participating State that is a Member State or a hosting consortium of Participating States. The Joint Undertaking should own the part that corresponds to the Union’s share of the financial contribution to the acquisition costs from Digital Europe Programme funds. The hosting entity should be selected by the Governing Board following a call for expression of interest evaluated by independent experts. The share of the Union’s access time to each mid-range supercomputer should be directly proportional to the financial contribution of the Union from Digital Europe Programme funds to the acquisition costs of that mid-range supercomputer. The Joint Undertaking should be able to transfer its ownership to the hosting entity at the earliest five years after the successful acceptance test by the Joint Undertaking or when it is being wound up. The hosting entity should reimburse the Joint Undertaking the residual value of the supercomputer. (46) To promote an equitable and balanced distribution across the Union of EuroHPC supercomputers and the emergence of a federated infrastructure ecosystem approach, the calls for expression of interest of a EuroHPC supercomputer should define the eligibility conditions that should apply to a Participating State which is already hosting a EuroHPC supercomputer. (47) The Joint Undertaking should be able to acquire together with a consortium of private partners industrial-grade supercomputers. The operation of each such supercomputer should be entrusted to an existing hosting entity. The hosting entity should be able to associate itself with the consortium of private partners for the acquisition and operation of such a supercomputer. The Joint Undertaking should own the part that corresponds to the Union’s share of financial contribution to the acquisition costs from the Digital Europe Programme funds. The hosting entity and its associated consortium of private partners should be selected by the Governing Board following a call for expression of interest evaluated by independent experts. The share of the Union’s access time to such supercomputer should be directly proportional to the financial contribution of the Union from the Digital Europe Programme funds to the acquisition costs of that industrial-grade supercomputer. The Joint Undertaking should be able to reach an agreement with the consortium of private partners to sell such a supercomputer to another entity or decommission it. Alternatively, the Joint Undertaking should be able to transfer the ownership of such a supercomputer to the consortium of private partners. In that case or when the Joint Undertaking is being wound-up, the consortium of private partners should reimburse the Joint Undertaking the residual value of the Union’s share of the supercomputer. In the case that the Joint Undertaking and the consortium of private partners decide to proceed to the decommissioning of the supercomputer after the full depreciation of its operation, such costs should be covered by the consortium of private partners. (48) For industrial-grade supercomputers the Joint Undertaking should take into account the specific needs of industrial users, for example access procedures, quality and type of services, protection of data, protection of industrial innovation, and intellectual property, usability, trust, and other confidentiality and security requirements. (49) The design and operation of the supercomputers supported by the Joint Undertaking should take into consideration energy efficiency and environmental sustainability, using for example low-power technology, dynamic power-saving and re-use techniques like advanced cooling and heat recycling. (50) The use of the supercomputers of the Joint Undertaking should focus on civilian applications for public and private users residing, established or located in a Member State or in a third country associated to the Digital Europe Programme or to Horizon Europe, including applications in cybersecurity that may be of dual use. Users should be granted the Union’s share of access time according to access policy rules defined by the Governing Board. The use of these supercomputers should also respect international agreements concluded by the Union. (51) User allocation of access time to the supercomputers of the Joint Undertaking should be free of charge for public users. It should also be free of charge for private users for their applications related to research and innovation activities funded by Horizon Europe or the Digital Europe Programme, as well as for private innovation activities of SMEs, where appropriate. Such allocation of access time should primarily be based on open calls for expression of interest launched by the Joint Undertaking and evaluated by independent experts. With the exception of SME users undertaking private innovation activities, all users benefiting from free-of-charge access time to the supercomputers of the Joint Undertaking should adopt an open science approach and disseminate knowledge gained through that access, in accordance with Regulation (EU) 2021/695. User allocation of access time for economic activities other than private innovation activities of SMEs, which face particular market failures, should be granted on a pay-per-use basis, based on market prices. Allocation of access time for such economic activities should be allowed but limited and the level of the fee to be paid should be established by the Governing Board. The access rights should be allocated in a transparent manner. The Governing Board should define specific rules to grant access time free of charge, where appropriate, and without a call for expression of interest to initiatives that are considered strategic for the Union. Representative examples of strategic initiatives of the Union include: Destination Earth, the Human Brain Project Flagship, the ‘1+ Million Genomes’ initiative, the common European data spaces operating in domains of public interest, and in particular the health data space, the Centres of Excellence in High Performance Computing, national High Performance Computing Competence Centres and the Digital Innovation Hubs. Upon the Union’s request, the Joint Undertaking should grant direct access time on a temporary or permanent basis to strategic initiatives and existing or future application platforms that it considers essential for providing health-related or other crucial emergency support services for the public good, to emergency and crisis management situations or to cases that the Union considers essential for its security and defence. The Joint Undertaking should be allowed to carry out some limited economic activities for commercial purposes. Access should be granted to users residing, established or located in a Member State or a third country associated to the Digital Europe Programme or to Horizon Europe. The access rights should be equitable to any user and allocated in a transparent manner. The Governing Board should define and monitor the access rights to the Union’s share of access time for each supercomputer. (52) Access to the Union’s share of access time of the precursors to exascale and petascale supercomputers acquired by the EuroHPC Joint Undertaking established under Regulation (EU) 2018/1488 should continue to be granted to users established in the Union or a third country associated to Horizon 2020. (53) The supercomputers of the Joint Undertaking should be operated and used in compliance with Regulation (EU) 2016/679 of the European Parliament and of the Council (8) and Directives 2002/58/EC (9) and (EU) 2016/943 (10) of the European Parliament and of the Council. (54) Governance of the Joint Undertaking should be assured by two bodies: a Governing Board, and an Industrial and Scientific Advisory Board. The Governing Board should be composed of representatives of the Union and of Participating States. The Governing Board should be responsible for strategic policy-making and funding decisions related to the activities of the Joint Undertaking, including all the public procurement activities. The Industrial and Scientific Advisory Board should include representatives of academia and industry as users and technology suppliers. It should provide independent advice to the Governing Board on the Strategic Research and Innovation Agenda, on the acquisition and operation of the supercomputers owned by the Joint Undertaking, the capability building and widening activities programme and the federation, connectivity and international cooperation activities programme. (55) For the general administrative tasks of the Joint Undertaking, the voting rights of the Participating States should be distributed equally among them. For the tasks corresponding to the setting up of the part of the work programme related to the acquisition of the supercomputers and quantum computers, the selection of the hosting entity, the federation and connectivity activities and the research and innovation activities of the Joint Undertaking, the voting rights of the Participating States that are Member States should be based on the principle of qualified majority. The Participating States that are third countries associated to Horizon Europe, the Digital Europe Programme or the Connecting Europe Facility should also hold voting rights for the respective activities that are supported with budgetary envelopes from each of those programmes. For the tasks corresponding to the acquisition and operation of the supercomputers and quantum computers, only those Participating States and the Union that contribute resources to those tasks should have voting rights. (56) The Union’s financial contribution should be managed in accordance with the principle of sound financial management and with the relevant rules on indirect management set out in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (11). The rules applicable for the Joint Undertaking to enter into public procurement procedures should be set out in its financial rules. (57) To foster an innovative and competitive European High Performance Computing and quantum computing ecosystem of recognised excellence across Europe, the Joint Undertaking should make appropriate use of the procurement and grant instruments, including joint procurement, pre-commercial procurement and public procurement of innovative solutions. This aims at creating links between technologies primarily developed in the Union, co-design with users and the acquisition of first-of-a-kind world-class supercomputing and quantum computing systems. (58) In assessing the overall impact of the Joint Undertaking, investments in indirect actions from the Private Members should be taken into account as in-kind contributions consisting of the eligible costs incurred by them in implementing actions, less the contributions by the Joint Undertaking, the Participating States or any other Union contribution to those costs. In assessing the overall impact of the Joint Undertaking, investments in other actions from the Private Members should be taken into account as in-kind contributions consisting of the eligible costs incurred by them in implementing the actions, less the contributions by the Joint Undertaking, the Participating States or any other Union contribution to those costs. (59) In order to maintain a level playing field for all undertakings active in the internal market, funding from the Union programmes should be consistent with State aid principles so as to ensure the effectiveness of public spending and prevent market distortions such as crowding out of private funding, the creation of ineffective market structures, the preservation of inefficient firms or the creation of a subsidies-reliant culture. (60) Participation in indirect actions funded by the Joint Undertaking should comply with Regulation (EU) 2021/695. The Joint Undertaking should, moreover, ensure the consistent application of those rules based on relevant measures adopted by the Commission. In order to ensure appropriate co-financing of indirect actions by the Participating States, in compliance with Regulation (EU) 2021/695, the Participating States should contribute an amount at least equal to the reimbursement provided by the Joint Undertaking for the eligible costs incurred by beneficiaries in implementing the actions. To that effect, the maximum funding rates set out in the annual work programme of the Joint Undertaking should be fixed by the Governing Board in accordance with Article 34 of Regulation (EU) 2021/695. (61) In order to ensure the right balance of stakeholders’ participation in the actions funded by the Joint Undertaking, a derogation from Article 34 of Regulation (EU) 2021/695 is necessary to allow a differentiation of reimbursement rates depending on the type of participant, namely SMEs, and the type of action, to be applied invariably across beneficiaries from all Participating States. For activities funded under the Digital Europe Programme, the Joint Undertaking should allow reimbursement rates depending on the type of participant, namely SMEs, and the type of action, to be applied invariably across beneficiaries from all Participating States. (62) Provision of financial support to activities from the Digital Europe Programme should comply with Regulation (EU) 2021/694. In particular, in relation to classified information, actions funded under the Digital Europe Programme should comply with Article 12(1) of that Regulation. (63) Provision of financial support to activities from the Connecting Europe Facility should comply with Regulation (EU) 2021/1153. (64) Beneficiaries from third countries associated to Horizon Europe, the Digital Europe Programme or the Connecting Europe Facility that are Participating States should be eligible for participation in actions only where a Participating State is a third country associated to one or more programmes related to that action. (65) The financial interests of the Union and of the other members of the Joint Undertaking should be protected by proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of lost, wrongly paid or incorrectly used funds and, where appropriate, the application of administrative and financial penalties in accordance with Regulation (EU, Euratom) 2018/1046. (66) The Joint Undertaking should operate in an open and transparent way providing all relevant information in a timely manner as well as promoting its activities, including information and dissemination activities, to the wider public. The rules of procedure of the bodies of the Joint Undertaking should be made publicly available. (67) For the purpose of simplification, the administrative burden should be reduced for all parties. Double audits and disproportionate amounts of documentation and reporting should be avoided. (68) The Commission’s internal auditor should exercise the same powers over the Joint Undertaking as those exercised in respect of the Commission. (69) The Commission, the Joint Undertaking, the Court of Auditors and the European Anti-Fraud Office (OLAF) and the European Public Prosecutor’s Office (EPPO) should have access to all necessary information and the premises to conduct audits and investigations on the grants, contracts and agreements signed by the Joint Undertaking. (70) All calls for proposals and all calls for tenders under this Regulation should take into account the duration of Horizon Europe, of the Digital Europe Programme and of the Connecting Europe Facility, as appropriate, except in duly justified cases. Procurement procedures for the acquisition of the supercomputers and quantum computers of the Joint Undertaking should be in accordance with the applicable provisions of the Digital Europe Programme. In duly justified cases related to availability of remaining budget stemming from the MFF 2021-2027, the Joint Undertaking should be able to launch calls for proposals or calls for tenders by 31 December 2028. (71) An interim and a final evaluation of the Joint Undertaking should be conducted by the Commission with the assistance of independent experts. In a spirit of transparency, the relevant independent experts’ report should be made publicly available, in compliance with the applicable rules. (72) Since the objectives of this Regulation, namely the strengthening of research and innovation capabilities, the development of supercomputing capability building and widening activities, the federation, connectivity and international cooperation and the acquisition of world-class supercomputers, and access to High Performance Computing, quantum computing service and data infrastructure across the Union by means of a Joint Undertaking, cannot be sufficiently achieved by the Member States, but can rather, by reason of avoiding unnecessary duplication, retaining critical mass and ensuring that public financing is used in an optimal way, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, HAS ADOPTED THIS REGULATION: Article 1 Establishment 1. For the implementation of the initiative on European High Performance Computing, a Joint Undertaking within the meaning of Article 187 of the Treaty on the Functioning of the European Union (TFEU) (the ‘European High Performance Computing Joint Undertaking’, the ‘Joint Undertaking’) is hereby established for a period until 31 December 2033. 2. In order to take into account the duration of the MFF 2021-2027 and of Horizon Europe, the Digital Europe Programme and the Connecting Europe Facility, calls for proposals and calls for tenders under this Regulation shall be launched by 31 December 2027. In duly justified cases, calls for proposals or calls for tenders may be launched by 31 December 2028. 3. The Joint Undertaking shall have legal personality. In each Member State, it shall enjoy the most extensive legal capacity accorded to legal persons under the laws of that Member State. It may, in particular, acquire or dispose of movable and immovable property and may be a party to legal proceedings. 4. The seat of the Joint Undertaking shall be located in Luxembourg. 5. The Statutes of the Joint Undertaking (‘the Statutes’) are set out in the Annex. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘acceptance test’ means a test conducted to determine if the requirements of the system specification are met by a EuroHPC supercomputer; (2) ‘access time’ means the computing time of a supercomputer that is made available to a user or a group of users to execute their computer programmes; (3) ‘affiliated entity’ means any legal entity as defined in Article 187(1) of Regulation (EU, Euratom) 2018/1046; (4) ‘Centre of Excellence in High Performance Computing’ means a collaborative project selected in an open and competitive call for proposals to promote the use of upcoming extreme performance computing capabilities enabling user communities in collaboration with other High Performance Computing stakeholders to scale up existing parallel codes towards exascale and extreme scaling performance; (5) ‘co-design’ means a collective approach between technology suppliers and users engaged in a collaborative and iterative design process for developing new technologies, applications and systems; (6) ‘conflict of interest’ means a situation involving a financial actor or other person as referred to in Article 61 of Regulation (EU, Euratom) 2018/1046; (7) ‘constituent entity’ means an entity that constitutes a Private Member of the Joint Undertaking, pursuant to the statutes of each Private Member; (8) ‘consortium of private partners’ means an association of Union legal entities coming together for the purpose of acquiring jointly with the Joint Undertaking an industrial-grade supercomputer; one or more of these private partners may be participating in the Private Members of the Joint Undertaking; (9) ‘EuroHPC supercomputer’ means any computing system fully owned by the Joint Undertaking or co-owned with other Participating States or a consortium of private partners; it can be a classical supercomputer (high-end supercomputer, industrial-grade supercomputer, or mid-range supercomputer), a hybrid classical-quantum computer, a quantum computer or a quantum simulator; (10) ‘exascale’ means a performance level capable of executing ten to the power of eighteen operations per second (or 1 Exaflop); (11) ‘high-end supercomputer’ means a world-class computing system developed with the most advanced technology available at a given point in time and achieving at least exascale levels of performance or beyond (i.e. post-exascale) for applications addressing problems of greater complexity; (12) ‘hosting consortium’ means a group of Participating States or a consortium of private partners that have agreed to contribute to the acquisition and operation of a EuroHPC supercomputer, including any organisations representing these Participating States; (13) ‘hosting entity’ means a legal entity which includes facilities to host and operate a EuroHPC supercomputer and which is established in a Participating State that is a Member State; (14) ‘hyper-connected’ means a communication capability of transferring data at 10 to the power of twelve bits per second (1 Terabit per second) or beyond; (15) ‘industrial-grade supercomputer’ means at least a mid-range supercomputer specifically designed with security, confidentiality and data integrity requirements for industrial users that are more demanding than for a scientific use; (16) ‘in-kind contributions to indirect actions’ funded from Horizon Europe means contributions by the Participating State or the Private Members of the Joint Undertaking or their constituent entities or their affiliated entities, consisting of the eligible costs incurred by them in implementing indirect actions less the contribution of that Joint Undertaking, of the Participating States of that Joint Undertaking and of any other Union contribution to those costs; (17) ‘in-kind contributions to actions’ funded from the Digital Europe Programme or the Connecting Europe Facility means contributions by the Participating State or the Private Members of the Joint Undertaking or their constituent entities or their affiliated entities, consisting of the eligible costs incurred by them in implementing part of the activities of the Joint Undertaking less the contribution of that Joint Undertaking, of the Participating States of that Joint Undertaking and of any other Union contribution to those costs; (18) ‘mid-range supercomputer’ means a world-class supercomputer with at most one order of magnitude lower performance level than a high-end supercomputer; (19) ‘national High Performance Computing Competence Centre’ means a legal entity, or a consortium of legal entities, established in a Participating State, associated with a national supercomputing centre of that Participating State, providing users from industry, including SMEs, academia, and public administrations with access on demand to the supercomputers and to the latest High Performance Computing technologies, tools, applications and services, and offering expertise, skills, training, networking and outreach; (20) ‘observer State’ means a country eligible to participate in the actions of the Joint Undertaking funded by Horizon Europe or the Digital Europe Programme that is not a Participating State; (21) ‘Participating State’ means a country that is a member of the Joint Undertaking; (22) ‘performance level’ means the number of floating point operations per second (flops) that a supercomputer can execute; (23) ‘Private Member’ means any member of the Joint Undertaking other than the Union or Participating States; (24) ‘quantum computer’ means a computing device that harnesses the laws of quantum mechanics to solve certain particular tasks using therefore fewer computational resources than classical computers; (25) ‘quantum simulator’ means a highly controllable quantum device that allows to obtain insights into properties of complex quantum systems or to solve specific computational problems inaccessible to classical computers; (26) ‘security of the supply chain’ of a EuroHPC supercomputer means the measures to include in the selection of any supplier of this supercomputer to ensure the availability of components, technologies, systems and knowhow required in the acquisition and operation of this supercomputer; this includes measures for mitigating the risks related to eventual disruptions in the supply of such components, technologies, and systems, including price changes or lower performance or alternative sources of supply; it covers the whole lifetime of the EuroHPC supercomputer; (27) ‘Strategic Research and Innovation Agenda’ means the document covering the duration of Horizon Europe that identifies the key priorities and the essential technologies and innovations required to achieve the objectives of the Joint Undertaking; (28) ‘multiannual strategic programme’ means a document laying out a strategy for all the activities of the Joint Undertaking; (29) ‘supercomputing’ means computing at performance levels requiring the massive integration of individual computing elements, including quantum components, for solving problems which cannot be handled by standard computing systems; (30) ‘total cost of ownership’ of a EuroHPC supercomputer means the acquisition costs plus the operating costs, including maintenance, until the ownership of the supercomputer is transferred to the hosting entity or is sold, or until the supercomputer is decommissioned without transfer of ownership; (31) ‘work programme’ means the document referred to in Article 2, point (25), of Regulation (EU) 2021/695 or, where relevant, the document which also functions as the work programme referred to in Article 24 of Regulation (EU) 2021/694, or Article 19 of Regulation (EU) 2021/1153. Article 3 Mission and objectives 1. The mission of the Joint Undertaking shall be: to develop, deploy, extend and maintain in the Union a world-leading federated, secure and hyper-connected supercomputing, quantum computing, service and data infrastructure ecosystem; to support the development and uptake of demand-oriented and user-driven innovative and competitive supercomputing systems based on a supply chain that will ensure components, technologies and knowledge limiting the risk of disruptions and the development of a wide range of applications optimised for these systems; and, to widen the use of that supercomputing infrastructure to a large number of public and private users, and support the twin transition and the development of key skills for European science and industry. 2. The Joint Undertaking shall have the following overall objectives: (a) to contribute to the implementation of Regulation (EU) 2021/695 and in particular Article 3 thereof, to deliver scientific, economic, environmental, technological and societal impact from the Union’s investments in research and innovation, so as to strengthen the scientific and technological bases of the Union, deliver on the Union strategic priorities and contribute to the realisation of Union objectives and policies, and to contribute to tackling global challenges, including the Sustainable Development Goals by following the principles of the United Nations Agenda 2030 and the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (12); (b) to develop close cooperation and ensure coordination with other European Partnerships, including through joint calls, as well as to seek synergies with relevant activities and programmes at Union, national, and regional level, in particular with those supporting the deployment of innovative solutions, education and regional development, where relevant; (c) to develop, deploy, extend and maintain in the Union an integrated, demand-oriented and user-driven hyper-connected world-class supercomputing and data infrastructure; (d) to federate the hyper-connected supercomputing and data infrastructure and interconnect it with the European data spaces and cloud ecosystem for providing computing and data services to a wide range of public and private users in Europe; (e) to promote scientific excellence and support the uptake and systematic use of research and innovation results generated in the Union; (f) to further develop and support a highly competitive and innovative supercomputing and data ecosystem broadly distributed in Europe contributing to the scientific and digital leadership of the Union, capable of autonomously producing computing technologies and architectures and their integration on leading computing systems, and advanced applications optimised for these systems; (g) to widen the use of supercomputing services and the development of key skills that European science and industry need. 3. The Joint Undertaking shall contribute to safeguarding the interests of the Union when procuring supercomputers and supporting the development and uptake of High Performance Computing technologies, systems and applications. It shall enable a co-design approach for the acquisition of world-class supercomputers, while safeguarding the security of the supply chain of procured technologies and systems. It shall contribute to the Union’s strategic autonomy, support the development of technologies and applications reinforcing the European High Performance Computing supply chain and promote their integration in supercomputing systems that address a large number of scientific, societal, environmental and industrial needs. Article 4 Pillars of activity 1. The Joint Undertaking shall implement the mission referred to in Article 3 according to the following pillars of activities: (a) administration pillar, covering the general activities for the operation and management of the Joint Undertaking; (b) infrastructure pillar, encompassing the activities for the acquisition, deployment, upgrading and operation of the secure, hyper-connected world-class supercomputing, quantum computing and data infrastructure, including the promotion of the uptake and systematic use of research and innovation results generated in the Union; (c) federation of supercomputing services pillar, covering all activities for providing Union-wide access to federated, secure supercomputing and data resources and services throughout Europe for the research and scientific community, industry, including SMEs, and the public sector, in particular in cooperation with PRACE and GÉANT; those activities shall include: (i) support to the interconnection of the High Performance Computing, quantum computing and data resources owned fully or partially by the Joint Undertaking or made available on a voluntary basis by the Participating States; (ii) support to the interconnection of the supercomputing, and quantum computing data infrastructures with the Union’s common European data spaces and federated, secure cloud and data infrastructures; (iii) support to the development, acquisition and operation of a platform for the seamless federation and secure service provisioning of supercomputing and quantum computing service and data infrastructure, establishing a one-stop shop access point for any supercomputing or data service managed by the Joint Undertaking, providing any user with a single point of entry; (d) technology pillar, addressing ambitious research and innovation activities for developing a world-class, competitive and innovative supercomputing ecosystem across Europe addressing hardware and software technologies, and their integration into computing systems, covering the whole scientific and industrial value chain, for contributing to the Union’s strategic autonomy; it shall also focus on energy-efficient High Performance Computing technologies, contributing to environmental sustainability; those activities shall address inter alia: (i) low-power micro-processing components, interconnection components, system architecture and related technologies such as novel algorithms, software codes, tools, and environments; (ii) emerging computing paradigms and their integration into leading supercomputing systems through a co-design approach; these technologies shall be linked with the development, acquisition and deployment of high-end supercomputers, including quantum computers, and infrastructures; (iii) technologies and systems for the interconnection and operation of classical supercomputing systems with other, often complementary computing technologies, such as quantum computing or other emerging computing technologies and ensure their effective operation; (iv) new algorithms and software technologies that offer substantial performance increases; (e) application pillar, addressing activities for achieving and maintaining European excellence in key computing and data applications and codes for science, industry, including SMEs, and the public sector; those activities shall address inter alia: (i) applications, including new algorithms and software developments, for public and private users that benefit from the exploitation of the resources and capabilities of high-end supercomputers and their convergence with advanced digital technologies such as artificial intelligence, high performance data analytics, cloud technologies, etc. through the co-design, development and optimisation of High Performance Computing-enabled large-scale and emerging lead-market codes and applications; (ii) support, among others, to Centres of Excellence in High Performance Computing in applications and large-scale High Performance Computing-enabled pilot demonstrators and test-beds for big data applications and advanced digital services in a wide range of scientific, public and industrial sectors; (f) widening usage and skills pillar, aiming at developing capabilities and skills that foster excellence in supercomputing, quantum computing, and data use, taking into account synergies with other programmes and instruments, in particular Digital Europe Programme, widening the scientific and industrial use of supercomputing resources and data applications and fostering the industrial access and use of supercomputing and data infrastructures for innovation adapted to industrial needs, as well as providing Europe with a knowledgeable leading scientific community and a skilled workforce for scientific leadership and digital transformation of industry and public administration, including the support and networking of national High Performance Computing Competence Centres and Centres of Excellence in High Performance Computing; (g) international cooperation pillar, in line with the external policy objectives and international commitments of the Union, defining, implementing and participating in activities relevant to the promotion of international collaboration in supercomputing to solve global scientific and societal challenges, while promoting competitiveness of the European High Performance Computing supply and user ecosystem. 2. In addition to the activities referred to in paragraph 1, the Joint Undertaking may be entrusted with the implementation of additional tasks in the event of cumulative, complementary or combined funding between Union programmes in accordance with the relevant Commission work programme. Article 5 Union’s financial contribution 1. The Union financial contribution to the Joint Undertaking including EEA appropriations shall be up to EUR 3 081 300 000, including EUR 92 000 000 for administrative costs, on the condition that that amount is at least matched by the contribution of Participating States, distributed as follows: (a) up to EUR 900 000 000 from Horizon Europe; (b) up to EUR 1 981 300 000 from the Digital Europe Programme; (c) up to EUR 200 000 000 from the Connecting Europe Facility. 2. The Union financial contribution referred to in paragraph 1 shall be paid from the appropriations in the general budget of the Union allocated to each relevant programme. 3. Additional Union funds complementing the contribution referred to in paragraph 1 of this Article may be allocated to the Joint Undertaking to support its pillars of activities referred to in Article 4, except those referred to in Article 4(1)(a). 4. Contributions from Union programmes corresponding to additional activities entrusted to the Joint Undertaking in accordance with paragraph 3 shall not be accounted for in the calculation of the Union maximum financial contribution. 5. Additional Union funds complementing the contribution referred to in paragraph 1 of this Article may be allocated to the Joint Undertaking from third countries associated to Horizon Europe, the Digital Europe Programme or the Connecting Europe Facility in accordance with their respective association agreements. Those additional Union funds shall not affect the Participating States’ contribution referred to in Article 7(1), unless the Participating States agree otherwise. 6. The Union financial contribution referred to in paragraph 1(a) of this Article shall be used for the Joint Undertaking to provide financial support to indirect actions as defined in Article 2, point (43), of Regulation (EU) 2021/695, corresponding to the research and innovation activities of the Joint Undertaking. 7. The Union financial contribution referred to in paragraph 1(b) shall be used for capability building across the whole Union, including the acquisition, upgrade and operation of High Performance Computers, quantum computers or quantum simulators, the federation of the High Performance Computing and quantum computing service and data infrastructure and the widening of its use, and the development of advanced skills and training. 8. The Union financial contribution referred to in paragraph 1(c) shall be used for the interconnection of the High Performance Computing and data resources and the creation of an integrated pan-European hyper-connected High Performance Computing and data infrastructure. Article 6 Other Union contributions Contributions from Union programmes other than those referred to in Article 5(1) that are part of a Union co-financing to a programme implemented by one of the Participating States that is a Member State shall not be accounted for in the calculation of the Union maximum financial contribution referred to in Article 5. Article 7 Contributions of members other than the Union 1. The Participating States shall make a total contribution that is commensurate to the Union’s contribution referred to in Article 5(1). The Participating States shall arrange among them their collective contributions and how they will deliver them. This shall not affect the ability of each Participating State to define its national financial contribution in accordance with Article 8. 2. The Private Members of the Joint Undertaking shall make or arrange for their constituent entities and affiliated entities to make contributions for at least EUR 900 000 000 to the Joint Undertaking. 3. The contributions referred to in paragraphs 1 and 2 of this Article shall consist of contributions as set out in Article 15 of the Statutes. 4. The contributions referred to in Article 15(3)(f) of the Statutes may be provided by each Participating State to beneficiaries established in that Participating State. Participating States may complement the Joint Undertaking’s contribution, within the applicable maximum reimbursement rate set out in Article 34 of Regulation (EU) 2021/695, Article 14 of Regulation (EU) 2021/694 and in Article 14 of Regulation (EU) 2021/1153. Such contributions shall be without prejudice to State aid rules. 5. The members of the Joint Undertaking other than the Union shall report by 31 January of each year to the Governing Board as defined in Article 15 of the Statutes, on the value of the contributions referred to in paragraphs 1 and 2 of this Article made in the previous financial year. 6. For the purpose of valuing the contributions referred to in points Article 15(3)(b) to (f) of the Statutes, the costs shall be determined in accordance with the usual cost accounting practices of the entities concerned, with the applicable accounting standards of the country where the entity is established and with the applicable International Accounting Standards and International Financial Reporting Standards. The costs shall be certified by an independent external auditor appointed by the entity concerned or by the audit authorities of the Participating States. The valuation method may be verified by the Joint Undertaking, should there be any uncertainty arising from the certification. If there are remaining uncertainties, the valuation method may be audited by the Joint Undertaking. 7. The Commission may terminate, proportionally reduce or suspend the Union financial contribution to the Joint Undertaking or trigger the winding up procedure referred to in Article 23 of the Statutes in the following cases: (a) if the Joint Undertaking fails to meet the conditions for the Union contribution; or (b) if the members other than the Union or their constituent entities or their affiliated entities fail to contribute, contribute only partially or do not respect the time frames with regard to the contribution referred to in paragraphs 1 and 2 of this Article; or (c) as a result of the evaluations referred to in Article 24. The Commission’s decision to terminate, proportionally reduce or suspend the Union financial contribution shall not hinder the reimbursement of eligible costs incurred by the members other than the Union before the decision is notified to the Joint Undertaking. Article 8 Management of contributions from the Participating States 1. Each Participating State shall make an indicative commitment of the amount of their national financial contributions in indirect actions to the Joint Undertaking. Such a commitment shall be made annually to the Joint Undertaking prior to the adoption of the work programme. In addition to the criteria set out in Article 22 of Regulation (EU) 2021/695, in Article 18 of Regulation (EU) 2021/694 or in Article 11 of Regulation (EU) 2021/1153, the work programme may include, as an annex, eligibility criteria regarding the participation of national legal entities. Each Participating State shall entrust the Joint Undertaking with the evaluation of the proposals in accordance with Horizon Europe rules. The selection of proposals shall be based on the ranking list provided by the evaluation committee. The Governing Board may deviate from that list in duly justified cases as set out in the work programme to ensure the overall consistency of the portfolio approach. Each Participating State shall have a right of veto on all issues concerning the use of its own national financial contributions to the Joint Undertaking for applicants established in those Participating States, on the basis of national strategic priorities. 2. Each Participating State shall conclude one or more administrative agreements with the Joint Undertaking laying down the coordination mechanism for the payment of and reporting on contributions to applicants established in that Participating State. Such an agreement shall include the schedule, conditions of payment, reporting and audit requirements. Each Participating State shall strive to synchronise its payment schedule, reporting and audits, with those of the Joint Undertaking and to converge its cost eligibility rules with Horizon Europe’s rules. 3. In the agreement referred to in paragraph 2, each Participating State may entrust the Joint Undertaking with the payment of its contribution to its beneficiaries. After the selection of proposals, the Participating State shall commit the amount necessary for payments. The audit authorities of the Participating State may audit their respective national contributions. Article 9 Hosting entity 1. EuroHPC supercomputers shall be located in a Participating State that is a Member State. In case a Participating State is already hosting a EuroHPC supercomputer which is a high-end or a mid-range supercomputer, it shall not be eligible to participate in a new call for expression of interest for the incremental generation of such supercomputers before at least five years from the selection date following a previous call for expression of interest. In the case of the acquisition of quantum computers and quantum simulators, or the upgrade of a EuroHPC supercomputer with quantum accelerators, that period is reduced to two years. 2. For the EuroHPC supercomputers referred to in Articles 11, 12 and 14, the hosting entity may represent a Participating State that is a Member State or a hosting consortium. The hosting entity and the competent authorities of the Participating State or Participating States in a hosting consortium shall enter into an agreement to that effect. 3. The Joint Undertaking shall entrust to a hosting entity the operation of each individual EuroHPC supercomputer fully owned by the Joint Undertaking, or jointly owned in accordance with Articles 11, 12 and 14. 4. Hosting entities referred to in paragraph 2 of this Article shall be selected in accordance with paragraph 5 of this Article and the Joint Undertaking’s financial rules referred to in Article 19. 5. Following a call for expression of interest, the hosting entity referred to in paragraph 2 of this Article and the corresponding Participating State where the hosting entity is established or the corresponding hosting consortium shall be selected by the Governing Board through a fair and transparent process based, inter alia, on the following criteria: (a) compliance with the general system specifications defined in the call for expression of interest; (b) total cost of ownership of the EuroHPC supercomputer, including an accurate estimate and a verification method of the operating costs of this supercomputer during its lifetime; (c) experience of the hosting entity in installing and operating similar systems; (d) quality of the hosting facility’s physical and IT infrastructure, its security and its connectivity with the rest of the Union; (e) quality of service to the users, namely capability to comply with the service level agreement provided among the documents accompanying the selection procedure; (f) provision of an appropriate supporting document proving the commitment of the Member State where the hosting entity is established or of the competent authorities of the Participating States of the hosting consortium to cover the share of the total cost of ownership of the EuroHPC supercomputer that is not covered by the Union contribution as set out in Article 5 or any other Union contribution as set out in Article 6, either until its ownership is transferred by the Joint Undertaking to that hosting entity or until the supercomputer is sold or decommissioned if there is no transfer of ownership. 6. For the industrial-grade EuroHPC supercomputers referred to in Article 13, the hosting entity shall enter into an agreement with a consortium of private partners for preparing the acquisition and for operating such supercomputers or partitions of EuroHPC supercomputers. Hosting an industrial-grade supercomputer shall respect the following conditions: (a) the Joint Undertaking shall entrust to the hosting entity the operation of each individual industrial-grade EuroHPC supercomputer jointly owned in accordance with Article 13; (b) hosting entities shall be selected in accordance with paragraph 5 of this Article and the Joint Undertaking’s financial rules referred to in Article 19; (c) following a call for expression of interest, the hosting entity and its associated consortium of private partners shall be selected by the Governing Board through a fair and transparent process based, inter alia, on the following: (i) the criteria set out in paragraphs 5(a) to 5(e) of this Article; and (ii) the provision of an appropriate supporting document proving the commitment of the consortium of private partners to cover the share of the total cost of ownership of the EuroHPC supercomputer that is not covered by the Union contribution as set out in Article 5 or any other Union contribution as set out in Article 6. 7. The selected hosting entity may decide to invite, subject to the prior agreement of the Commission, additional Participating States, or a consortium of private partners, to join the hosting consortium. The financial or in-kind contribution or any other commitment of the joining Participating States, or Private Members, shall not affect the Union financial contribution and the corresponding ownership rights and percentage of access time allocated to the Union with regard to that EuroHPC supercomputer as defined in Articles 11, 12, 13, and 14. Article 10 Hosting agreement 1. The Joint Undertaking shall conclude a hosting agreement with each selected hosting entity prior to launching the procedure for the acquisition of a EuroHPC supercomputer. 2. The hosting agreement shall address in particular the following elements regarding the EuroHPC supercomputers: (a) the rights and obligations during the procedure for acquisition of the supercomputer, including the acceptance tests of the supercomputer; (b) the liability conditions for operating the supercomputer; (c) the quality of service offered to the users when operating the supercomputer, as set out in the service level agreement; (d) the plans regarding the supercomputer’s energy efficiency and environmental sustainability; (e) the access conditions of the Union’s share of access time to the supercomputer, as decided by the Governing Board in accordance with Article 17; (f) the accounting modalities of the access times; (g) the share of the total cost of ownership that the hosting entity shall arrange to be covered by the Participating State where the hosting entity is established or by the Participating States in the hosting consortium; (h) the conditions for the transfer of ownership referred to in Articles 11(5), 12(7), 13(6) and 14(6), including, in the case of EuroHPC supercomputers, provisions for the calculation of their residual value and for their decommissioning; (i) the obligation of the hosting entity to provide access to the EuroHPC supercomputers, while ensuring the security of the supercomputers, the protection of personal data in accordance with Regulation (EU) 2016/679, the protection of privacy of electronic communications in accordance with Directive 2002/58/EC, the protection of trade secrets in accordance with Directive (EU) 2016/943 and the protection of confidentiality of other data covered by the obligation of professional secrecy; (j) the obligation of the hosting entity to put in place a certified audit procedure covering the costs of operation of the EuroHPC supercomputer and the access times of the users; (k) the obligation of the hosting entity to submit by 31 January of each year to the Governing Board an audit report and data on the use of access time in the previous financial year; (l) the specific conditions applicable when the hosting entity operates a EuroHPC supercomputer for industrial usage. 3. The hosting agreement shall be governed by Union law, supplemented, for any matter not covered by this Regulation or by other Union legal acts, by the law of the Member State where the hosting entity is established. 4. The hosting agreement shall contain an arbitration clause, within the meaning of Article 272 TFEU, granting jurisdiction over all matters covered by the hosting agreement to the Court of Justice of the European Union. 5. After the hosting agreement is concluded, and without prejudice to paragraph 2 of this Article, the Joint Undertaking, supported by the selected hosting entity, shall launch the procedures for the acquisition of the EuroHPC supercomputer in accordance with the financial rules of the Joint Undertaking referred to in Article 19. 6. For mid-range supercomputers, after the hosting agreement is concluded, the Joint Undertaking, or the hosting entity shall launch on behalf of both contracting parties the procedures for the acquisition of the EuroHPC supercomputer in accordance with the financial rules of the Joint Undertaking referred to in Article 19. Article 11 Acquisition and ownership of high-end supercomputers 1. The Joint Undertaking shall acquire the high-end supercomputers and shall own them. 2. The Union financial contribution referred to in Article 5(1) shall cover up to 50 % of the acquisition costs plus up to 50 % of the operating costs of the high-end supercomputers. The remaining total cost of ownership of the high-end supercomputers shall be covered by the Participating State where the hosting entity is established or by the Participating States in the hosting consortium, possibly supplemented by the contributions referred to in Article 6. 3. The selection of the supplier of the high-end supercomputer shall be based on tender specifications that shall take into account the user requirements and the general system specifications provided by the selected hosting entity in its application for the call for expression of interest. The selection shall also address the security of the supply chain. 4. The Joint Undertaking may act as first user and acquire high-end supercomputers that integrate demand-oriented, user driven and competitive technologies primarily developed in the Union. 5. The Governing Board may decide in the work programme, if duly justified for security reasons, to condition the participation of suppliers in the acquisition of the high-end supercomputers in accordance with Article 12(6) of Regulation (EU) 2021/694 or to limit the participation of suppliers for security reasons or actions directly related to the Union’s strategic autonomy, in accordance with Article 18(4) of that Regulation. 6. Without prejudice to the winding up of the Joint Undertaking, as referred to in Article 23(4) of the Statutes, at the earliest five years after the successful acceptance test by the Joint Undertaking of the high-end supercomputers installed in a hosting entity, the ownership of the high-end supercomputer may be transferred to the respective hosting entity, sold to another entity or decommissioned upon decision of the Governing Board and in accordance with the hosting agreement. In the case of transfer of ownership of a high-end supercomputer, the hosting entity shall reimburse the Joint Undertaking the residual value of the supercomputer that is transferred. If there is no transfer of ownership to the hosting entity but a decision for decommissioning, the relevant costs shall be shared equally by the Joint Undertaking and the hosting entity. The Joint Undertaking shall not be liable for any costs incurred after the transfer of ownership of the high-end supercomputer or after its sale or decommissioning. Article 12 Acquisition and ownership of quantum computers and quantum simulators 1. The Joint Undertaking shall acquire quantum computers and quantum simulators, that could range from pilots and experimental systems to prototypes and operational systems as stand-alone machines or hybridised with high-end or mid-range High Performance Computing machines and accessible via the cloud, and shall own them. 2. The Union financial contribution referred to in Article 5(1) shall cover up to 50 % of the acquisition costs plus up to 50 % of the operating costs of the quantum computers and quantum simulators. The remaining total cost of ownership of the quantum computers and quantum simulators shall be covered by the Participating State where the hosting entity is established or by the Participating States in the hosting consortium, possibly supplemented by the contributions referred to in Article 6. 3. The selection of the supplier of the quantum computers and quantum simulators shall be based on tender specifications that shall take into account the user requirements and the general system specifications provided by the selected hosting entity in its application for the call for expression of interest. The selection shall also address the security of the supply chain. 4. The Joint Undertaking may act as first user and acquire quantum computers and quantum simulators that integrate technologies primarily developed in the Union. 5. The Governing Board may decide in the work programme, if duly justified for security reasons, to condition the participation of suppliers in the acquisition of the quantum computers and quantum simulators in accordance with Article 12(6) of Regulation (EU) 2021/694 or to limit the participation of suppliers for security reasons or actions directly related to the Union’s strategic autonomy, in accordance with Article 18(4) of that Regulation. 6. The quantum computers and quantum simulators shall be located in a hosting entity of a EuroHPC supercomputer or a supercomputing centre located in the Union. 7. Without prejudice to the winding up of the Joint Undertaking, as referred to in Article 23(4) of the Statutes, at the earliest four years after the successful acceptance test by the quantum computer or quantum simulator installed in a hosting entity, the ownership of the quantum computer or quantum simulator may be transferred to that hosting entity, sold to another entity or decommissioned upon decision of the Governing Board and in accordance with the hosting agreement. In the case of transfer of ownership of a quantum computer or quantum simulator, the hosting entity shall reimburse the Joint Undertaking the residual value of the supercomputer that is transferred. If there is no transfer of ownership to the hosting entity but a decision for decommissioning, the relevant costs shall be shared equally by the Joint Undertaking and the hosting entity. The Joint Undertaking shall not be liable for any costs incurred after the transfer of ownership of the quantum computer or quantum simulator or after its sale or decommissioning. Article 13 Acquisition and ownership of industrial-grade EuroHPC supercomputers 1. The Joint Undertaking shall acquire, together with a consortium of private partners, at least mid-range supercomputers, or partitions of EuroHPC supercomputers, primarily destined for use by industry, and shall own them or co-own them with a consortium of private partners. 2. The Union financial contribution referred to in Article 5(1) shall cover up to 35 % of the acquisition costs of the EuroHPC supercomputers, or the partitions of the EuroHPC supercomputers. The remaining total cost of ownership of the EuroHPC supercomputers, or the partitions of the EuroHPC supercomputers, shall be covered by the consortium of private partners. 3. The selection of the supplier of an industrial-grade EuroHPC supercomputer shall be based on tender specifications that shall take into account the user requirements and the general system specifications provided by the selected hosting entity in its application for the call for expression of interest. The selection shall also address the security of the supply chain. 4. The Governing Board may decide in the work programme, if duly justified for security reasons, to condition the participation of suppliers in the acquisition of the industrial grade EuroHPC supercomputers in accordance with Article 12(6) of Regulation (EU) 2021/694 or to limit the participation of suppliers for security reasons or actions directly related to the Union’s strategic autonomy, in accordance with Article 18(4) of that Regulation. 5. The EuroHPC supercomputers or the EuroHPC supercomputer partitions for industrial use shall be hosted in a hosting entity of a EuroHPC supercomputer. 6. Without prejudice to the winding up of the Joint Undertaking, as referred to in Article 23(4) of the Statutes, at the earliest four years after the successful acceptance test by the Joint Undertaking of the EuroHPC supercomputers installed in a hosting entity, the ownership of the EuroHPC supercomputer may be transferred to the consortium of private partners, sold to another entity or decommissioned upon decision of the Governing Board and in accordance with the consortium of private partners. In the case of transfer of ownership of a EuroHPC supercomputer, the consortium of private partners shall reimburse the Joint Undertaking the residual value of the EuroHPC supercomputer that is transferred. If there is no transfer of ownership to the consortium of private partners but a decision for decommissioning, the relevant costs shall be covered by the consortium of private partners. The Joint Undertaking shall not be liable for any costs incurred after the transfer of ownership of the EuroHPC supercomputer or after its sale or decommissioning. Article 14 Acquisition and ownership of the mid-range supercomputers 1. The Joint Undertaking shall acquire, jointly with the contracting authorities of the Participating State where the hosting entity is established or with the contracting authorities of the Participating States in the hosting consortium, the mid-range supercomputers and shall co-own them. 2. The Union financial contribution referred to in Article 5(1) shall cover up to 35 % of the acquisition costs and up to 35 % of operating costs of the mid-range supercomputers. The remaining total cost of ownership of the mid-range supercomputers shall be covered by the Participating State where the hosting entity is established or the Participating States in the hosting consortium, possibly supplemented by the contributions referred to in Article 6. 3. The selection of the supplier of the mid-range supercomputer shall be based on tender specifications that shall take into account the user requirements and the general system specifications provided by the selected hosting entity in its application for the call for expression of interest. The selection shall also address the security of the supply chain. 4. The Joint Undertaking may act as first user and acquire mid-range supercomputers that integrate demand-oriented, user driven and competitive technologies primarily developed in the Union. 5. The Governing Board may decide in the work programme, if duly justified for security reasons, to condition the participation of suppliers in the acquisition of the mid-range supercomputers in accordance with Article 12(6) of Regulation (EU) 2021/694 or to limit the participation of suppliers for security reasons or actions directly related to the Union’s strategic autonomy, in accordance with Article 18(4) of that Regulation. 6. Without prejudice to the winding up of the Joint Undertaking, as referred to in Article 23(4) of the Statutes, the part of the ownership of the supercomputer owned by the Joint Undertaking shall be transferred to the hosting entity after the full depreciation of the supercomputer. The hosting entity shall reimburse the Joint Undertaking the residual value of the supercomputer that is transferred. The Joint Undertaking shall not be liable for any costs incurred after the transfer of ownership of the mid-range supercomputer. Article 15 Upgrading of supercomputers 1. The Joint Undertaking may launch a call for expressions of interest to upgrade the EuroHPC supercomputers it owns or co-owns. The maximum EU contribution to such upgrades may not exceed EUR 150 million for the period 2021-2027. 2. A hosting entity shall be eligible to respond to this call for expressions of interest at the earliest one year after the selection date of the hosting entity of the EuroHPC supercomputer, and no later than three years after this date. A EuroHPC supercomputer may be upgraded only once. 3. The hosting entity shall be selected by the Governing Board through a fair and transparent process based, inter alia, on the following criteria: (a) justification of the upgrade; (b) compatibility with the original EuroHPC supercomputer; (c) increase in operational capacity performance of the EuroHPC supercomputer; (d) provision of an appropriate supporting document proving the commitment of the Member State where the hosting entity is established or of the competent authorities of the Participating States of the hosting consortium to cover the share of the upgrading cost of the EuroHPC supercomputer that is not covered by the Union contribution as set out in Article 5 or any other Union contribution as set out in Article 6, either until its ownership is transferred by the Joint Undertaking to that hosting entity or until the supercomputer is sold or decommissioned if there is no transfer of ownership. 4. The Joint Undertaking shall acquire, jointly with the contracting authorities of the Participating State where the selected hosting entity is established or with the contracting authorities of the Participating States in the selected hosting consortium, the upgrade of the supercomputer and shall own it under the same conditions of ownership of the original EuroHPC supercomputer. 5. The Union financial contribution for the upgrade shall cover up to 35 % of the acquisition costs of the upgrade, depreciated over the expected remaining lifetime of the original supercomputer and up to 35 % of the additional operating costs. The total cost of the upgrade shall not exceed 30 % of the total acquisition cost of the original EuroHPC supercomputer. 6. The share of the Union’s access time to the upgraded EuroHPC supercomputer shall remain unchanged over the lifetime of the machine. If the upgrade entails an increase of capacity, the additional access time shall be directly proportional to the Union contribution. Article 16 Use of EuroHPC supercomputers 1. Without prejudice to Article 17(9), the use of EuroHPC supercomputers shall be open to users from the public and private sectors and shall focus on civilian applications. Except for the industrial-grade EuroHPC supercomputers, their use shall be primarily for research and innovation purposes falling under public funding programmes, for public sector applications and for private innovation activities of SMEs, where appropriate. 2. The Governing Board shall define the general access conditions for using the EuroHPC supercomputers in accordance with Article 17 and may define specific access conditions for different types of users or applications. The security and quality of service shall be the same for all users within each user category, except for the industrial-grade EuroHPC supercomputers, whose security and quality of service shall be compliant with industrial requirements, in accordance with Article 13(1). 3. Users residing, established or located in a Member State or in a third country associated to Horizon 2020 shall be granted access to the Union’s share of access time of the supercomputers acquired by the EuroHPC Joint Undertaking established by Regulation (EU) 2018/1488. 4. Users residing, established or located in a Member State or in a third country associated to the Digital Europe Programme or to Horizon Europe shall be granted the Union’s share of access time to EuroHPC supercomputers acquired after 2020. 5. In duly justified cases, taking into account the interests of the Union, the Governing Board shall decide to grant access time to EuroHPC supercomputers to entities residing, established or located in any third country and to international organisations. Article 17 Allocation of Union’s access time to the EuroHPC supercomputers 1. The share of the Union’s access time to each high-end and quantum EuroHPC supercomputer shall be directly proportional to the financial contribution of the Union referred to in Article 5(1) to the total cost of ownership of the EuroHPC supercomputer and shall thus not exceed 50 % of the total access time of the EuroHPC supercomputer. 2. The share of the Union’s access time to each mid-range EuroHPC supercomputer shall be directly proportional to the financial contribution of the Union, referred to in Article 5(1), to the acquisition and operating cost of the supercomputer and shall not exceed 35 % of the total access time of the supercomputer. 3. The share of the Union’s access time to each industrial-grade EuroHPC supercomputer shall be directly proportional to the financial contribution of the Union, referred to in Article 5(1), to the acquisition cost of the supercomputer and shall not exceed 35 % of the total access time of the supercomputer. 4. Each Participating State where a hosting entity is established or each Participating State in a hosting consortium shall be allocated the remaining access time to each EuroHPC supercomputer. In the case of a hosting consortium, the Participating States shall agree among themselves the distribution of access time to the supercomputer. 5. The Governing Board shall define the access rights to the Union’s share of access time to the EuroHPC supercomputers. 6. Use of the Union’s share of access time to the EuroHPC supercomputers shall be free of charge for the users from the public sector referred to in Article 16(4). It shall also be free of charge for industrial users for applications related to research and innovation activities funded by Horizon Europe or the Digital Europe Programme as well as those awarded a Seal of Excellence under Horizon Europe or the Digital Europe Programme and for private innovation activities of SMEs, where appropriate. As a guiding principle, allocation of access time for such activities shall be based on a fair and transparent peer review process defined by the Governing Board following continuously open calls for expression of interest launched by the Joint Undertaking. 7. With the exception of SME users undertaking private innovation activities, other users shall adopt an open science approach to disseminating knowledge gained through access to the supercomputers of the Joint Undertaking, in accordance with Article 14 of Regulation (EU) 2021/695. The Governing Board shall define further the applicable open science rules. 8. The Governing Board shall define specific rules for access conditions that depart from the guiding principles referred to in paragraph 6. These concern the allocation of access time for projects and activities considered as strategic for the Union. 9. Upon request of the Union, the Executive Director shall grant direct access to the EuroHPC supercomputers to initiatives that the Union considers essential for providing health- or climate-related or other crucial emergency support services for the public good, to emergency and crisis management situations or to cases that the Union considers essential for its security and defence. The modalities and conditions for the implementation of such access shall be defined in the access conditions adopted by the Governing Board. 10. The Governing Board shall define the conditions that apply for industrial use to provide access to the Union’s share of access time to secure High Performance Computing and data resources for applications other than those specified in paragraph 6. 11. The Governing Board shall regularly monitor the Union’s share of access time granted per Participating State and per user category, including for commercial purposes. It may decide among others to: (a) re-adapt access times per category of activity or user, with the aim to optimise the use capabilities of the EuroHPC supercomputers; (b) propose additional support measures for providing fair access opportunities to users that would aim to raise their level of skills and expertise in High Performance Computing systems. Article 18 Union’s access time to EuroHPC supercomputers for commercial purposes 1. Specific conditions shall apply to all industry users for commercial purposes on the Union’s share of access time. This service for commercial use shall be a pay-per-use service, based on market prices. The level of the fee shall be established by the Governing Board. 2. The fees generated by the commercial use of the Union’s share of access time shall constitute revenue to the Joint Undertaking budget and shall be used to cover operational costs of the Joint Undertaking. 3. The access time allocated to commercial services shall not exceed 20 % of the Union’s total access time of each EuroHPC supercomputer. The Governing Board shall decide on the allocation of the Union’s access time for the users of commercial services, taking into account the outcome of the monitoring referred to in Article 17(11). 4. The quality of commercial services shall be the same for all users. Article 19 Financial rules 1. The Joint Undertaking shall adopt its specific financial rules in accordance with Article 71 of Regulation (EU, Euratom) 2018/1046. 2. The financial rules shall be published on the website of the Joint Undertaking. Article 20 Staff 1. The Staff Regulations of Officials of the European Union (‘Staff Regulations’) and the Conditions of Employment of Other Servants of the European Union (‘Conditions of Employment’), laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (13), and the rules adopted jointly by the institutions of the Union for the purpose of applying the Staff Regulations and Conditions of Employment shall apply to the staff of the Joint Undertaking. 2. The Governing Board shall exercise, with respect to the staff of the Joint Undertaking, the powers conferred by the Staff Regulations on the Appointing Authority and by the Conditions of Employment on the Authority empowered to conclude contracts (‘the appointing authority powers’). 3. The Governing Board shall adopt, in accordance with Article 110 of the Staff Regulations, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment delegating the relevant appointing authority powers to the Executive Director and defining the conditions under which that delegation may be suspended. The Executive Director shall be authorised to sub-delegate those powers. 4. Where exceptional circumstances so require, the Governing Board may decide to temporarily suspend the delegation of the appointing authority powers to the Executive Director and any subsequent sub-delegation of those powers by the latter. In such cases, the Governing Board shall exercise the appointing authority powers itself or shall delegate them to one of its members or to a staff member of the Joint Undertaking other than the Executive Director. 5. The Governing Board shall adopt appropriate implementing rules giving effect to the Staff Regulations and the Conditions of Employment in accordance with Article 110 of the Staff Regulations. 6. The staff resources shall be set out in the staff establishment plan of the Joint Undertaking, indicating the number of temporary posts by function group and by grade, as well as by the number of contract staff expressed in full-time equivalents, in accordance with its annual budget. 7. The staff of the Joint Undertaking shall consist of temporary staff and contract staff. 8. All costs related to staff shall be borne by the Joint Undertaking. Article 21 Seconded national experts and trainees 1. The Joint Undertaking may make use of seconded national experts and trainees not employed by the Joint Undertaking. The number of seconded national experts expressed in full-time equivalents shall be added to the information on staff resources as referred to in Article 20(6) in accordance with the annual budget. 2. The Governing Board shall adopt a decision laying down rules on the secondment of national experts to the Joint Undertaking and on the use of trainees. Article 22 Privileges and Immunities Protocol No 7 on the privileges and immunities of the European Union, annexed to the TEU and the TFEU, shall apply to the Joint Undertaking and its staff. Article 23 Liability of the Joint Undertaking 1. The contractual liability of the Joint Undertaking shall be governed by the relevant contractual provisions and by the law applicable to the agreement, decision or contract in question. 2. In the case of non-contractual liability, the Joint Undertaking shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its staff in the performance of their duties. 3. Any payment by the Joint Undertaking in respect of the liability referred to in paragraphs 1 and 2, and the costs and expenses incurred in that respect, shall be considered as expenditure of the Joint Undertaking and shall be covered by its resources. 4. The Joint Undertaking shall be solely responsible for meeting its obligations. 5. The Joint Undertaking shall not be held liable for any damage resulting from the actions of the hosting entity regarding the operation by the hosting entity of the supercomputers owned by the EuroHPC Joint Undertaking. Article 24 Monitoring and evaluation 1. The activities of the Joint Undertaking shall be subject to continuous monitoring and periodic reviews in accordance with its financial rules, to ensure the highest impact and excellence, as well as the most effective and efficient use of resources. The outcomes of monitoring and periodic reviews shall feed into the monitoring of European Partnerships and evaluations of the Joint Undertaking as part of the Horizon Europe evaluations referred to in Articles 50 and 52 of Regulation (EU) 2021/695. 2. The Joint Undertaking shall organise the continuous monitoring of its management and implementation activities and periodic reviews of the outputs, results and impacts of the projects implemented in line with Article 50 of, and Annex III to, Regulation (EU) 2021/695. 3. Evaluations of the Joint Undertakings’ operations shall be carried out in a timely manner to feed into the interim evaluation and final evaluation of Horizon Europe and the related decision-making process as specified in Article 52 of Regulation (EU) 2021/695. 4. The Commission shall carry out an interim and a final evaluation of the Joint Undertaking as part of the Horizon Europe evaluations referred to in Article 52 of Regulation (EU) 2021/695. The interim evaluation shall be performed with the assistance of independent experts on the basis of a transparent process once there is sufficient information available about the implementation of Horizon Europe, but no later than four years after the start of the implementation of Horizon Europe. The evaluations shall examine how the Joint Undertaking fulfils its mission in accordance with its economic, technological, scientific, societal and policy objectives, including climate-related objectives, and evaluate the effectiveness, efficiency, relevance, coherence, and Union added value of its activities as part of Horizon Europe, its synergies and complementarities with relevant European, national and, where relevant, regional initiatives, including synergies with other parts of Horizon Europe, such as missions, clusters or thematic or specific programmes. The evaluations shall take into account the views of stakeholders, at both European and national levels, and shall, where relevant, also include an assessment of the long-term scientific, societal, economic and policy-relevant impact of the Joint Undertaking. They shall also include an assessment of the most effective policy intervention mode for any future action, as well as the relevance and coherence of any possible renewal of the Joint Undertaking in the overall European Partnerships landscape and its policy priorities. 5. On the basis of the conclusions of the interim evaluation referred to in paragraph 4 of this Article, the Commission may act in accordance with Article 7(7) or take any other appropriate action. 6. The Commission may carry out further evaluations of themes or topics of strategic relevance, with the assistance of external independent experts selected on the basis of a transparent process, to examine the progress made by the Joint Undertaking towards the objectives set, identify the factors contributing to the implementation of the activities and identify best practices. By carrying out those further evaluations, the Commission shall fully consider the administrative impact on the Joint Undertaking. 7. The Joint Undertaking shall perform periodic reviews of its activities to inform the interim evaluation and final evaluation of the Joint Undertaking as part of Horizon Europe evaluations referred to in Article 52 of Regulation (EU) 2021/695. 8. Periodic reviews and evaluations shall inform the winding up or possible renewal of the Joint Undertaking, in line with Annex III to Regulation (EU) 2021/695. Within six months after the winding-up of the Joint Undertaking, but no later than two years after the triggering of the winding-up procedure referred to in Article 23 of the Statutes, the Commission shall conduct a final evaluation of the Joint Undertaking. The results of that final evaluation shall be presented to the European Parliament and to the Council. 9. The Commission shall publish and communicate the results of the evaluations of the Joint Undertaking, which shall include conclusions of the evaluation and observations by the Commission, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions as part of the Horizon Europe evaluations referred to in Article 52 of Regulation (EU) 2021/695. Article 25 Jurisdiction of the Court of Justice of the European Union and applicable law 1. The Court of Justice of the European Union shall have jurisdiction: (a) pursuant to any arbitration clause contained in agreements or contracts concluded by the Joint Undertaking, or in its decisions; (b) in disputes relating to compensation for damage caused by the staff of the Joint Undertaking in the performance of their duties; (c) in any dispute between the Joint Undertaking and its staff within the limits and under the conditions laid down in the Staff Regulations or the Conditions of Employment. 2. With regard to any matter not covered by this Regulation or by other Union legal acts, the law of the Member State where the seat of the Joint Undertaking is located shall apply. Article 26 Complaints to the Ombudsman Decisions taken by the Joint Undertaking in implementing this Regulation may form the subject of a complaint to the Ombudsman in accordance with Article 228 TFEU. Article 27 Ex post audits 1. Ex post audits of expenditure on actions funded by the Horizon Europe budget shall be carried out in accordance with Article 53 of Regulation (EU) 2021/695 as part of the Horizon Europe indirect actions, in particular in line with the audit strategy referred to in Article 53(2) of that Regulation. 2. Ex post audits of expenditure on activities funded by the Digital Europe Programme budget shall be carried out by the Joint Undertaking in accordance with Article 27 of Regulation (EU) 2021/694. 3. Ex post audits of expenditure on activities funded by the Connecting Europe Facility budget shall be carried out by the Joint Undertaking in accordance with Article 26 of Regulation (EU) 2021/1153 as part of the Connecting Europe Facility actions. Article 28 Protection of the financial interests of the members 1. The Joint Undertaking shall grant Commission staff and other persons authorised by the respective Joint Undertaking or the Commission, as well as the Court of Auditors or, for the purpose of the audit referred to in Article 8(3), the audit authorities of the Participating States, access to its sites and premises and to all the information, including information in electronic format, needed in order to conduct their audits. 2. OLAF and EPPO may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Council Regulation (Euratom, EC) No 2185/96 (14) and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (15) and with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with an agreement, a decision or a contract funded under this Regulation. 3. Without prejudice to paragraphs 1 and 2 of this Article, agreements, decisions and contracts resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the respective Joint Undertaking, the Court of Auditors, EPPO and OLAF, and, for the purpose of the audit referred to in Article 8(3), the audit authorities of the Participating States, to conduct such audits, on-the spot checks and investigations in accordance with their respective competences. 4. The Joint Undertaking shall ensure that the financial interests of its members are adequately protected by carrying out or commissioning appropriate internal and external controls. 5. The Joint Undertaking shall accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-fraud Office (OLAF) (16). The Joint Undertaking shall adopt the necessary measures needed to facilitate internal investigations conducted by OLAF. Article 29 Confidentiality The Joint Undertaking shall ensure the protection of sensitive information the disclosure of which could damage the interests of its members or of participants in the activities of the Joint Undertaking. Article 30 Transparency Regulation (EC) No 1049/2001 of the European Parliament and of the Council (17) shall apply to documents held by the Joint Undertaking. Article 31 Processing of personal data Where the implementation of this Regulation requires the processing of personal data, they shall be processed in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (18). Article 32 Access to results and information on proposals 1. The Joint Undertaking shall provide the Union institutions, bodies, offices or agencies, as well as the authorities of Participating States, access to all information related to the indirect actions it funds. Such information shall include results of beneficiaries participating in indirect actions of the Joint Undertaking or any other information deemed necessary for developing, implementing, monitoring and evaluating Union policies or programmes. Such access rights are limited to non-commercial and non-competitive use and shall comply with applicable confidentiality rules. 2. For the purposes of developing, implementing, monitoring and evaluating Union policies or programmes, the Joint Undertaking shall provide the Commission with information included in submitted proposals. This shall apply mutatis mutandis to Participating States regarding proposals which include applicants established in their territories, limited to non-commercial and non-competitive use and in accordance with applicable confidentiality rules. Article 33 Rules for participation and dissemination applicable to indirect actions funded under Horizon Europe 1. Regulation (EU) 2021/695 shall apply to the indirect actions funded by the Joint Undertaking under Horizon Europe. In accordance with that Regulation, the Joint Undertaking shall be considered as a funding body and shall provide financial support to indirect actions as set out in Article 1 of the Statutes. 2. Regulation (EU) 2021/695 shall also apply to the indirect actions funded by the Participating State contributions referred to in Article 15(3)(f) of the Statutes. Article 34 Reimbursement rates For indirect actions funded under Horizon Europe, by way of derogation from Article 34 of Regulation (EU) 2021/695, and for activities funded under the Digital Europe Programme, the Joint Undertaking may apply different reimbursement rates for Union funding within an action depending on the type of participant, namely SMEs, and the type of action. The reimbursement rates shall be indicated in the work programme. Article 35 Rules applicable to the activities funded under the Connecting Europe Facility Regulation (EU) 2021/1153 shall apply to the activities funded by the Joint Undertaking under the Connecting Europe Facility. Article 36 Rules applicable to the activities funded under the Digital Europe Programme Regulation (EU) 2021/694 shall apply to the activities funded by the Joint Undertaking under the Digital Europe Programme. Article 37 Support from the host Member State An administrative agreement may be concluded between the Joint Undertaking and the Member State where its seat is located concerning privileges and immunities and other support to be provided by that State to the Joint Undertaking. Article 38 Repeal 1. Without prejudice to actions initiated under Regulation (EU) 2018/1488, including annual implementation plans and financial obligations related to those actions, Regulation (EU) 2018/1488 is repealed. As regards the actions initiated under Articles 10, 11, 13 and 14 of Regulation (EU) 2018/1488, as well as Articles 6 and 7 of the Statutes annexed to that Regulation, it shall continue to apply until their completion and to the extent necessary. Actions arising from calls for proposals and calls for tenders provided for in annual implementation plans adopted under Regulation (EU) 2018/1488 shall also be regarded as actions initiated under that Regulation. 2. References to Regulation (EU) 2018/1488 shall be construed as references to this Regulation. Article 39 Transitional provisions 1. This Regulation shall not affect the rights and obligations of staff engaged under Regulation (EU) 2018/1488. To that effect, the employment contracts of staff shall continue under this Regulation in accordance with the Staff Regulations and Conditions of Employment. 2. The Executive Director appointed under Regulation (EU) 2018/1488 shall, for the remaining period of the term of office, be assigned to the functions of the Executive Director provided for in this Regulation with effect from the entry into force of this Regulation. The other conditions of contract shall remain unchanged. 3. Unless otherwise agreed between members, all rights and obligations, including assets, debts or liabilities of the members held pursuant to Regulation (EU) 2018/1488, shall be transferred to the members pursuant to this Regulation. 4. At its first meeting after the entry into force of this Regulation, the Governing Board shall adopt a list of decisions adopted under Regulation (EU) 2018/1488 that shall continue to apply under this Regulation. Any unused appropriations under Regulation (EU) 2018/1488 shall be transferred to the Joint Undertaking established under this Regulation. 5. All rights and obligations including assets, debts or liabilities of the Joint Undertaking and any unused appropriations under Regulation (EU) 2018/1488 shall be transferred to the Joint Undertaking established under this Regulation. Article 40 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 13 July 2021. For the Council The President A. ŠIRCELJ (1) Opinion of 24 June 2021 (not yet published in the Official Journal). (2) Opinion of 27 January 2021 (OJ C 123, 9.4.2021, p. 7). (3) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1). (4) Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, p. 1). (5) Regulation (EU) 2021/1153 of the European Parliament and of the Council of 7 July 2021 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014 (OJ L 249, 14.7.2021, p. 38). (6) Council Regulation (EU) 2018/1488 of 28 September 2018 establishing the European High Performance Computing Joint Undertaking (OJ L 252, 8.10.2018, p. 1). (7) Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159). (8) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (9) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37). (10) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1). (11) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (12) OJ L 282, 19.10.2016, p. 4. (13) OJ L 56, 4.3.1968, p. 1. (14) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (15) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (16) OJ L 136, 31.5.1999, p. 15. (17) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (18) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). ANNEX STATUTES OF THE EUROPEAN HIGH PERFORMANCE COMPUTING JOINT UNDERTAKING Article 1 Tasks The Joint Undertaking shall carry out the following tasks: (a) mobilise public and private sector funds for the financing of the activities of the Joint Undertaking; (b) support the implementation of the mission, the objectives and the pillars of activities of the Joint Undertaking listed in Articles 3 and 4 of this Regulation; those activities will be funded by the Union’s budget stemming from Regulation (EU) 2021/695 establishing Horizon Europe, Regulation (EU) 2021/694 establishing Digital Europe Programme and Regulation (EU) 2021/1153 establishing the Connecting Europe Facility, in accordance with the scope of their respective Regulations and by contributions from the relevant Participating States to the Joint Undertaking; for that purpose the Joint Undertaking shall launch calls for proposals, calls for tenders, and any other instrument or procedure provided for in Horizon Europe, the Digital Europe Programme, and the Connecting Europe Facility; (c) initiate and manage the calls for expression of interest for hosting or upgrading EuroHPC supercomputers and evaluate the offers received, with the support of independent external experts; (d) select the hosting entity of the EuroHPC supercomputers in a fair, open and transparent manner, in accordance with Article 9 of this Regulation; (e) conclude a hosting agreement in accordance with Article 10 of this Regulation with the hosting entity for the operation and maintenance of the EuroHPC supercomputers and monitor the contractual compliance with the hosting agreement, including the acceptance test of the acquired supercomputers; (f) define general and specific conditions for allocating the Union’s share of access time to the EuroHPC supercomputers and monitor access to those supercomputers in accordance with Article 17 of this Regulation; (g) ensure the contribution of its operations to the achievement of the objectives of Horizon Europe, the strategic multiannual planning, reporting, monitoring and evaluation and other requirements of that programme such as the implementation of the common policy feedback framework; (h) initiate open calls for proposals and award funding in accordance with Regulation (EU) 2021/695, and within the limits of available funds, to indirect actions, mainly in the form of grants; (i) initiate open calls for proposals and calls for tenders and award funding in accordance with Regulation (EU) 2021/694 and Regulation (EU) 2021/1153 within the limits of available funds; (j) monitor the implementation of the actions and manage grant agreements and procurement contracts; (k) ensure the efficiency of the European High Performance Computing initiative, on the basis of a set of appropriate measures; (l) monitor overall progress towards achieving the objectives of the Joint Undertaking; (m) develop close cooperation and ensure coordination with Union and national activities, bodies and stakeholders, creating synergies and improving exploitation of research and innovation results in the area of High Performance Computing; (n) develop close cooperation and ensure coordination with other European Partnerships, as well as operational synergies in common back office functions with other Joint Undertakings; (o) define the multiannual strategic programme, draw up and implement the corresponding annual work programmes for their execution and make any necessary adjustments to the multiannual strategic programme; (p) engage in information, communication, exploitation and dissemination activities by applying mutatis mutandis Article 51 of Regulation (EU) 2021/695, including making the detailed information on results from calls for proposals available and accessible in a common Horizon Europe e-database; (q) perform any other task needed to achieve the objectives set out in Article 3 of this Regulation. Article 2 Members 1. The members of the Joint Undertaking shall be: (a) the Union, represented by the Commission; (b) Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden; (c) Montenegro, North Macedonia, Switzerland and Turkey, on the condition that those third countries are associated to at least one of the relevant programmes referred to in Article 5(1) of this Regulation; (d) upon acceptance of these Statutes by means of a letter of endorsement, the European Technology Platform for High Performance Computing (ETP4HPC) Association registered under Dutch law with its registered office in Amsterdam (the Netherlands) and Data, AI and Robotics (DAIRO) registered under Belgian law with its registered office in Brussels (Belgium). 2. Each Participating State shall appoint its representative in the Governing Board and shall designate the national entity or entities responsible for fulfilling its obligations under this Regulation. Article 3 Changes to membership 1. Provided that they contribute in accordance with Article 7 of this Regulation or to the financing referred to in Article 15 of these Statutes to achieve the mission and objectives of the Joint Undertaking set out in Article 3 of this Regulation, Member States or third countries associated to Horizon Europe or the Digital Europe Programme that are not listed in Article 2(1)(b) of these Statutes may apply to become members of the Joint Undertaking. 2. Any application of a Member State or a third country associated to Horizon Europe or the Digital Europe Programme for membership of the Joint Undertaking shall be addressed to the Governing Board. The candidate countries shall provide a written acceptance of these Statutes, and of any other provisions governing the functioning of the Joint Undertaking. The candidates shall also provide their motivation for requesting membership to the Joint Undertaking and indicate how their national supercomputing strategy is aligned with the Joint Undertaking’s objectives. The Governing Board shall assess the application, taking into account the relevance and the potential added value of the candidate as regards the achievement of the mission and objectives of the Joint Undertaking and may decide to ask for clarifications regarding the candidature before endorsing the application. 3. Provided that it contributes to the financing referred to in Article 15 of these Statutes to achieve the mission and objectives of the Joint Undertaking set out in Article 3 of this Regulation, and that it accepts these Statutes, any legal entity that is not listed in Article 2(1)(c) of these Statutes and is established in a Member State that directly or indirectly supports research and innovation in a Member State may apply to become a Private Member of the Joint Undertaking in accordance with paragraph 4 of this Article. 4. Any application for membership to become a Private Member of the Joint Undertaking made in accordance with paragraph 3 shall be addressed to the Governing Board. The Governing Board shall assess the application, taking into account the relevance and the potential added value of the applicant as regards the achievement of the mission and objectives of the Joint Undertaking and shall decide on the application. 5. Any member may terminate its membership in the Joint Undertaking. Such termination shall become effective and irrevocable six months after notification to the Executive Director, who shall inform the other members of the Governing Board and the Private Members thereof. As from the date of termination, the former member shall be discharged from any obligations other than those approved or incurred by the Joint Undertaking prior to the notification of termination of the membership. 6. Each Private Member shall inform the Joint Undertaking once a year of any significant changes in the composition of the Private Member. Where the Commission considers that the change in composition is likely to affect the Union’s or the Joint Undertaking’s interests on grounds of security, it may propose to the Governing Board to terminate the membership of the concerned Private Member. The termination shall become effective and irrevocable within six months of the decision of the Governing Board or on the date specified in that decision, whichever is earlier. 7. Membership in the Joint Undertaking may not be transferred to a third party without the prior agreement of the Governing Board. 8. Upon any change to the membership pursuant to this Article, the Joint Undertaking shall immediately publish on its website an updated list of the members together with the date of such change. Article 4 Bodies of the Joint Undertaking 1. The bodies of the Joint Undertaking shall be: (a) the Governing Board; (b) the Executive Director; (c) the Industrial and Scientific Advisory Board composed of the Research and Innovation Advisory Group and the Infrastructure Advisory Group. 2. When carrying out its tasks, each body of the Joint Undertaking shall only pursue the objectives set out in this Regulation and shall only act within the scope of the activities of the Joint Undertaking for the purpose of which it was established. Article 5 Composition of the Governing Board 1. The Governing Board shall be composed of representatives of the Commission, on behalf of the Union, and of the Participating States. 2. The Commission and each Participating State shall appoint one representative to the Governing Board. Article 6 Functioning of the Governing Board 1. The representatives of the members of the Governing Board shall make every effort to achieve consensus. Failing consensus, a vote shall be held. 2. The Union shall hold 50 % of the voting rights. The voting rights of the Union shall be indivisible. 3. For the tasks referred to in Article 7(3) of these Statutes, the remaining 50 % of the voting rights shall be distributed equally among all Participating States. For the purpose of this paragraph, decisions of the Governing Board shall be taken by a majority consisting of the Union’s vote and at least 50 % of all votes of the Participating States, including the votes of the members who are absent. 4. For the tasks referred to in Article 7(4) of these Statutes, except points (f), (g) and (h), the remaining 50 % of the voting rights shall be held by the Participating States that are Member States. For the purpose of this paragraph, decisions of the Governing Board shall be taken by a qualified majority. Qualified majority shall be deemed established if it represents the Union and at least 55 % of the Participating States that are Member States, comprising at least 65 % of the total population of these States. To determine the population, the figures set out in Annex III to Council Decision 2009/937/EU (1) shall be used. 5. For the tasks referred to in Article 7(4)(f), (g) and (h) of these Statutes, and for each EuroHPC supercomputer, the voting rights of the Participating States shall be distributed in proportion to their committed financial contributions and to their in-kind contributions to that supercomputer until either its ownership is transferred to the hosting entity in accordance with Article 9(3) of this Regulation or until it is sold or decommissioned; the in-kind contributions shall only be taken into account if they have been certified ex ante by an independent expert or auditor. For the purpose of this paragraph, decisions of the Governing Board shall be taken by a majority of at least 75 % of all votes, including the votes of the members who are absent. 6. For the tasks referred to in Article 7(5), 7(6) and 7(7) of these Statutes, decisions of the Governing Board shall be taken in two stages. At the first stage, the remaining 50 % of the voting rights shall be distributed equally among all Participating States. Decisions of the Governing Board shall be taken by a majority consisting of the Union’s vote and at least 55 % of all votes of Participating States, including the votes of the members who are absent. At the second stage, the Governing Board shall decide by the qualified majority referred to in paragraph 4 of this Article. 7. Without prejudice to the previous paragraphs, countries that were members of the Joint Undertaking under Regulation (EU) 2018/1488 and contributed to the acquisition or operation of the supercomputers acquired by the EuroHPC Joint Undertaking, established under that Regulation, but which are no longer members of the EuroHPC Joint Undertaking, shall maintain voting rights limited exclusively to decisions relating to those supercomputers in accordance with Articles 6(5) and 7(5) of the Statutes of the EuroHPC Joint Undertaking annexed to Regulation (EU) 2018/1488. 8. The Governing Board shall elect a chair for a period of two years. The mandate of the chairperson may be extended only once, following a decision by the Governing Board. 9. The vice chair of the Governing Board shall be the representative of the Commission, substituting the chair where necessary. 10. The Governing Board shall hold its ordinary meetings at least twice a year. It may hold extraordinary meetings at the request of the Commission, of a majority of the representatives of the Participating States, at the request of the chair, or at the request of the Executive Director in accordance with Article 15(5) of these Statutes. The meetings of the Governing Board shall be convened by its chair and shall usually take place at the seat of the Joint Undertaking. The Executive Director shall have the right to attend the meetings and take part in the deliberations but shall have no voting rights. The Governing Board may invite, on a case-by-case basis, other persons to attend its meetings as observers. Each observer State may appoint one delegate in the Governing Board, who shall receive all relevant documents and may participate in the deliberations of the Governing Board unless decided otherwise by the Governing Board on a case-by-case basis. Those delegates shall have no voting rights and shall ensure the confidentiality of sensitive information in accordance with Article 29 of this Regulation and be subject to the rules of conflict of interest. 11. The representatives of the members shall not be personally liable for any actions they have taken in their capacity as representatives on the Governing Board. 12. The Governing Board shall adopt and publish its own rules of procedure. Those rules shall include specific procedures for identifying and avoiding conflicts of interest and for ensuring the confidentiality of sensitive information. 13. The chairs of the Research and Innovation Advisory Group and of the Infrastructure Advisory Group of the Joint Undertaking shall be invited, whenever issues falling within their tasks are discussed, to attend meetings of the Governing Board as observers and take part in its deliberations, but shall have no voting rights. They shall ensure the confidentiality of sensitive information in accordance with Article 29 of this Regulation and be subject to the rules of conflict of interest. 14. The chairs of the Private Members of the Joint Undertaking shall be invited to attend the meetings of the Governing Board as observers and take part in its deliberations, but shall have no voting rights. They shall ensure the confidentiality of sensitive information in accordance with Article 29 of this Regulation and be subject to the rules of conflict of interest. Article 7 Tasks of the Governing Board 1. The Governing Board shall have overall responsibility for the strategic orientation and the operations of the Joint Undertaking and shall supervise the implementation of its activities. It shall ensure that the principles of fairness and transparency are properly applied in the allocation of public funding. 2. The Commission, in its role in the Governing Board, shall seek to ensure coordination between the activities of the Joint Undertaking and the relevant activities of Union funding programmes with a view to promoting synergies when developing an integrated supercomputing and data infrastructure ecosystem and when identifying priorities covered by collaborative research. 3. The Governing Board shall, in particular, carry out the following general administrative tasks of the Joint Undertaking: (a) assess, accept or reject applications for membership in accordance with Article 3(2) of these Statutes; (b) decide on the termination of membership in the Joint Undertaking of any member that does not fulfil its obligations; (c) discuss and adopt the financial rules of the Joint Undertaking in accordance with Article 19 of this Regulation; (d) discuss and adopt the annual administrative budget of the Joint Undertaking, including the corresponding staff establishment plan indicating the number of temporary posts by function group and by grade, the number of contract staff and seconded national experts expressed in full-time equivalents; (e) appoint, dismiss, extend the term of office of, provide guidance to and monitor the performance of the Executive Director; (f) discuss and approve the consolidated annual activity report, including the corresponding expenditure referred to in Article 18(1) of these Statutes; (g) exercise the powers of the appointing authority with respect to staff in accordance with Article 20 of this Regulation; (h) where appropriate, establish implementing rules to the Staff Regulations and the Conditions of Employment in accordance with Article 20(3) of this Regulation; (i) where appropriate, lay down rules on the secondment of national experts to the Joint Undertaking and on the use of trainees in accordance with Article 21(2) of this Regulation; (j) where appropriate, set up advisory groups in addition to the bodies of the Joint Undertaking referred to in Article 4 of these Statutes; (k) lay down rules and specific criteria for the selection, appointment and dismissal of members of the advisory groups set up in accordance with point (j), including considerations of gender and geographical diversity, and approve the rules of procedure laid down autonomously by these advisory groups; (l) discuss and approve the organisational structure of the Programme Office upon recommendation of the Executive Director; (m) where appropriate, submit to the Commission a request to amend this Regulation proposed by a member of the Joint Undertaking; (n) define the general and specific access conditions to use the Union’s share of access time of the EuroHPC supercomputers, in accordance with Article 17 of this Regulation; (o) establish the level of the fee of the commercial services referred to in Article 18 of this Regulation, and decide on the allocation of the access time for those services; (p) discuss and approve the Joint Undertaking’s communication policy upon recommendation by the Executive Director; (q) be responsible for any task that is not specifically allocated to a particular body of the Joint Undertaking; it may assign such tasks to any body of the Joint Undertaking. 4. The Governing Board shall, in particular, carry out the following tasks related to the acquisition and operation of the EuroHPC supercomputers and generated revenues referred to in Article 16 of this Regulation: (a) discuss and adopt the part of the multiannual strategic programme that is related to the acquisition of EuroHPC supercomputers referred to in Article 18(1) of these Statutes; (b) discuss and adopt the part of the annual work programme that is related to the acquisition of EuroHPC supercomputers and the selection of hosting entities and the corresponding expenditure estimates referred to in Article 18(4) of these Statutes; (c) approve the launch of calls for expression of interest, in accordance with the annual work programme; (d) approve the selection of the hosting entities for the EuroHPC supercomputers selected through a fair, open and transparent process in accordance with Article 9 of this Regulation; (e) decide annually on the use of any revenue generated by the fees for commercial services referred to in Article 18 of this Regulation; (f) approve the launch of calls for tenders, in accordance with the annual work programme; (g) approve the tenders selected for funding; (h) decide on the possible transfer of ownership of the EuroHPC supercomputers to a hosting entity, their sale to another entity or their decommissioning, in accordance with Articles 11(5), 12(7) and 14(6) of this Regulation; (i) decide on the possible transfer of ownership of the EuroHPC supercomputers to a consortium of private partners, their sale to another entity or their decommissioning, in accordance with Article 13(6) of this Regulation. 5. The Governing Board shall, in particular, carry out the following tasks related to the research and innovation activities, as well as the data use and skills activities of the Joint Undertaking: (a) discuss and adopt the part of the multiannual strategic programme that is related to the research and innovation activities referred to in Article 18(1) of these Statutes at the beginning of the initiative and amend it throughout the duration of Horizon Europe, if necessary; the multiannual strategic programme shall identify, inter alia, the other European partnerships with which the Joint Undertaking shall establish a formal and regular collaboration, as well as possibilities for synergies between the Joint Undertaking’s actions and national or regional initiatives and policies based on information received by the Participating States; (b) discuss and adopt the part of the annual work programme that is related to the research and innovation activities and the corresponding expenditure estimates referred to in Article 18(4) of these Statutes to implement the multiannual strategic programme, including the content of the calls for proposals, the applicable funding rate per call topic, as well as the related rules for submission, evaluation, selection, award and review procedures; (c) approve the launch of calls for proposals, in accordance with the annual work programme; (d) approve the list of actions selected for funding on the basis of the recommendation of the Executive Director pursuant to Article 8 of this Regulation; (e) be responsible for the close and timely monitoring of the progress of the Joint Undertaking’s research and innovation programme and individual actions in relation to the priorities of the Commission and the multiannual strategic programme and take corrective measures where needed to ensure that the Joint Undertaking meets its objectives. 6. The Governing Board shall, in particular, carry out the following tasks related to the capability building and widening activities of the Joint Undertaking: (a) discuss and adopt the part of the multiannual strategic programme that is related to the capability building and widening activities referred to in Article 18(1) of these Statutes; (b) discuss and adopt the part of the annual work programme that is related to the capability building and widening activities and the corresponding expenditure estimates referred to in Article 18(4) of these Statutes; (c) approve the launch of calls for proposals and calls for tenders, in accordance with the annual work programme; (d) approve the list of actions selected for funding on the basis of the recommendation of the Executive Director. 7. The Governing Board shall, in particular, carry out the following tasks related to the federation and connectivity of the High Performance Computing and data infrastructure activities, as well as the international cooperation activities of the Joint Undertaking: (a) discuss and adopt the part of the multiannual strategic programme that is related to the federation and connectivity of the High Performance Computing and data infrastructure activities, as well as the international cooperation activities referred to in Article 18(1) of these Statutes; (b) discuss and adopt the part of the annual work programme that is related to the federation and connectivity of the High Performance Computing and data infrastructure activities, as well as to the international cooperation activities and the corresponding expenditure estimates referred to in Article 18(4) of these Statutes; (c) approve the launch of calls for proposals and calls for tenders, in accordance with the annual work programme; (d) approve the list of actions selected for funding on the basis of the recommendation of the Executive Director. Article 8 Appointment, dismissal or extension of the term of office of the Executive Director 1. The Commission shall propose a list of candidates for Executive Director after consultation of the members of the Joint Undertaking other than the Union. For the purpose of such consultation the members of the Joint Undertaking other than the Union shall appoint by common accord their representatives as well as an observer on behalf of the Governing Board. The Executive Director shall be appointed by the Governing Board from a list of candidates proposed by the Commission following an open and transparent selection procedure. 2. The Executive Director shall be a member of staff and shall be engaged as a temporary agent of the Joint Undertaking under Article 2(a) of the Conditions of Employment. For the purpose of concluding the contract of the Executive Director, the Joint Undertaking shall be represented by the chair of the Governing Board. 3. The term of office of the Executive Director shall be four years. By the end of that period, the Commission, associating the members other than the Union as appropriate, shall undertake an assessment of the performance of the Executive Director and the Joint Undertaking’s future tasks and challenges. 4. The Governing Board, acting on a proposal from the Commission which takes into account the assessment referred to in paragraph 3, may extend the term of office of the Executive Director once, for a period of no more than four years. 5. An Executive Director whose term of office has been extended may not participate in another selection procedure for the same post at the end of the overall period. 6. The Executive Director may be dismissed only upon a decision of the Governing Board pursuant to Article 7(3)(e) of these Statutes acting on a proposal from the Commission associating the members other than the Union as appropriate. 7. The Commission may designate a Commission official to act as interim Executive Director and exercise the duties assigned to the Executive Director for any period that the position of Executive Director is vacant. Article 9 Tasks of the Executive Director 1. The Executive Director shall be the chief executive responsible for the day-to-day management of the Joint Undertaking in accordance with the decisions of the Governing Board. 2. The Executive Director shall be the legal representative of the Joint Undertaking. The Executive Director shall be accountable to the Governing Board and perform his or her duties with complete independence within the powers assigned to him or her. 3. The Executive Director shall implement the budget of the Joint Undertaking. 4. The Executive Director shall carry out, in particular, the following tasks in an independent manner: (a) submit for discussion and adoption to the Governing Board the draft multiannual strategic programme referred to in Article 18(1) of these Statutes; (b) prepare and submit to the Governing Board for discussion and adoption the draft annual budget, including the corresponding staff establishment programme indicating the number of temporary posts in each grade and function group and the number of contract staff and seconded national experts expressed in full-time equivalents; (c) prepare and submit to the Governing Board for discussion and adoption the draft annual work programme including the scope of the calls for proposals, calls for expression of interest and calls for tenders needed to implement the research and innovation activities programme, the procurement programme, the capability building and widening activities programme and the federation, connectivity and international cooperation activities programme, as proposed by the Industrial and Scientific Advisory Board, and the corresponding expenditure estimates, as proposed by the Participating States and the Commission; (d) submit the annual accounts to the Governing Board for its opinion; (e) prepare and submit for approval to the Governing Board the consolidated annual activity report, including the information on corresponding expenditure; (f) sign individual grant agreements, contracts and decisions in his or her remit on behalf of the Joint Undertaking; (g) sign procurement contracts; (h) monitor the operations of the EuroHPC supercomputers owned or funded by the Joint Undertaking, including the allocation of the Union’s share of access time, compliance with the access rights for academic and industrial users and quality of provided services; (i) propose the Joint Undertaking’s communication policy to the Governing Board; (j) organise, direct and supervise the operations and the staff of the Joint Undertaking within the limits of the delegation by the Governing Board as provided for in Article 20(2) of this Regulation; (k) establish and ensure the functioning of an effective and efficient internal control system and report any significant change to it to the Governing Board; (l) ensure that risk assessment and risk management are performed; (m) arrange, as appropriate, for the establishment of an internal audit capability of the Joint Undertaking; (n) allocate access time for emergencies and crisis management, in agreement with the access policy defined by the Governing Board; (o) take any other measures needed to assess the progress of the Joint Undertaking towards its objectives, as set out in Article 3 of this Regulation; (p) perform any other tasks entrusted or delegated to the Executive Director by the Governing Board. 5. The Executive Director shall set up a Programme Office for the execution, under his or her responsibility, of all support tasks arising from this Regulation. The Programme Office shall be composed of the staff of the Joint Undertaking and shall in particular carry out the following tasks: (a) provide support in establishing and managing an appropriate accounting system in accordance with the financial rules referred to in Article 19 of this Regulation; (b) manage the calls for proposals as provided for in the annual work programme and administer the grant agreements and decisions; (c) manage the calls for tenders as provided for in the annual work programme and administer the contracts; (d) manage the process for the selection of the hosting entities and administer the hosting agreements; (e) provide the members and the other bodies of the Joint Undertaking with all relevant information and support necessary for them to perform their duties, as well as respond to their specific requests; (f) act as the secretariat of the bodies of the Joint Undertaking and provide support to advisory groups set up by the Governing Board. Article 10 Composition of the Industrial and Scientific Advisory Board 1. The Industrial and Scientific Advisory Board shall be composed of a Research and Innovation Advisory Group and an Infrastructure Advisory Group. 2. The Research and Innovation Advisory Group shall consist of no more than twelve members, of which up to six shall be appointed by the Private Members taking into account their commitments to the Joint Undertaking and up to six shall be appointed by the Governing Board, in accordance with Article 7(3)(k) of these Statutes. 3. The Research and Innovation Advisory Group may include up to six observers proposed by Participating States and appointed by the Governing Board. 4. The Infrastructure Advisory Group shall consist of twelve members. The Governing Board shall appoint the members of the Infrastructure Advisory Group, in accordance with Article 7(3)(k) of these Statutes. 5. The members of the Research and Innovation Advisory Group and of the Infrastructure Advisory Group shall be appointed for a period of up to two years, renewable once. 6. The Research and Innovation Advisory Group and the Infrastructure Advisory Group shall meet at least once a year in order to coordinate their activities. Article 11 Functioning of the Research and Innovation Advisory Group 1. The Research and Innovation Advisory Group shall meet at least twice a year. 2. The Research and Innovation Advisory Group may appoint working groups where necessary under the overall coordination of one or more members. 3. The Research and Innovation Advisory Group shall elect its chair. 4. The Research and Innovation Advisory Group shall adopt its rules of procedure, including the nomination of the constituent entities that shall represent the Advisory Group and the duration of their nomination. Article 12 Functioning of the Infrastructure Advisory Group 1. The Infrastructure Advisory Group shall meet at least twice a year. 2. The Infrastructure Advisory Group may appoint working groups where necessary under the overall coordination of one or more members. 3. The Infrastructure Advisory Group shall elect its chair. 4. The Infrastructure Advisory Group shall adopt its rules of procedure, including the nomination of the constituent entities that shall represent the Advisory Group and the duration of their nomination. Article 13 Tasks of the Research and Innovation Advisory Group 1. The Research and Innovation Advisory Group shall: (a) draw up its contribution to the draft multiannual strategic programme in relation to research and innovation activities referred to in Article 18(1) of these Statutes and review it regularly in accordance with the evolution of the scientific and industrial demand; (b) organise public consultations open to all public and private stakeholders having an interest in the fields of High Performance Computing and quantum computing to inform them about, and collect feedback on, the draft multiannual strategic programme and the related draft activities of the research and innovation work programme for a given year. 2. The contribution to the draft multiannual strategic programme referred to in paragraph 1 shall include: (a) the strategic research and innovation agenda identifying the research and innovation priorities for the development and uptake of technologies and end-user applications for High Performance Computing across different application areas, in order to support the development of an integrated High Performance Computing, quantum computing and data ecosystem in the Union, to increase the Union’s resilience and to help create new markets and societal applications and measures to promote the development and uptake of European technology; (b) potential international cooperation activities in research and innovation that add value and are of mutual interest; (c) training and education priorities for addressing key competences and the skills gap in High Performance Computing and quantum computing technologies and applications, in particular for industry. Article 14 Tasks of the Infrastructure Advisory Group 1. The Infrastructure Advisory Group shall provide advice to the Governing Board for the acquisition and operation of the EuroHPC supercomputers. For that purpose, it shall: (a) draw up its contribution to the draft multiannual strategic programme referred to in Article 18(1) of these Statutes in relation to acquisition of EuroHPC computers and capability building and widening activities and review it regularly in accordance with the evolution of scientific and industrial demand; (b) organise public consultations open to all public and private stakeholders having an interest in the field of High Performance Computing, including quantum computing, to inform them about, and collect feedback on, the draft multiannual strategic programme for the acquisition and operation of the EuroHPC supercomputers and the related draft activities of the work programme for a given year. 2. The contribution to the draft multiannual strategic programme referred to in paragraph 1 shall address: (a) the acquisition of the EuroHPC supercomputers taking into account, inter alia, the planning of the acquisition, the needed capacity increases, the types of applications and user communities to be addressed, the relevant user requirements and appropriate system architectures, the user requirements, and the architecture of the infrastructure; (b) the federation and interconnection of this infrastructure, taking into account, inter alia, the integration with national High Performance Computing or quantum computing infrastructures, and the architecture of the hyper-connected and federated infrastructure; and (c) the capability building, including the national High Performance Computing Competence Centres and widening and training activities for end-users, as well as opportunities for promoting the take-up and use of European technology solutions notably by the national High Performance Computing Competence Centres. Article 15 Sources of financing 1. The Joint Undertaking shall be jointly funded by its members through financial contributions paid in instalments and in-kind contributions as set out in paragraphs 2 and 3. 2. The administrative costs of the Joint Undertaking shall not exceed EUR 92 000 000 and shall be covered by means of the financial contributions referred to in Article 5(1) of this Regulation. If part of the Union contribution for administrative costs is not used, it may be made available to cover the operational costs of the Joint Undertaking. 3. The operational costs of the Joint Undertaking shall be covered by means of: (a) the Union’s financial contribution; (b) financial contributions by the Participating State where the hosting entity is established or by the Participating States in a hosting consortium to the Joint Undertaking, including the Union contributions that are considered to be contributions of the Participating State pursuant to Article 15(3) of Regulation (EU) 2021/695, for the acquisition of the high-end EuroHPC supercomputers or quantum machines and for their operation until their ownership is transferred to the hosting entity, they are sold or decommissioned in accordance with Articles 11(5) and 12(7) of this Regulation, less the contributions by the Joint Undertaking and any other Union contribution to those costs; (c) in-kind contributions by the Participating State where the hosting entity is established or by the Participating States in a hosting consortium, including the Union contributions that are considered to be contributions of the Participating State pursuant to Article 15(3) of Regulation (EU) 2021/695, consisting of the operating costs of the EuroHPC supercomputers owned by the Joint Undertaking, incurred by the hosting entities, less the contributions by the Joint Undertaking and any other Union contribution to those costs; (d) financial contributions by the Participating State where the hosting entity is established or by the Participating States in a hosting consortium, including the Union contributions that are considered to be contributions of the Participating State pursuant to Article 15(3) of Regulation (EU) 2021/695, consisting of the costs incurred for the acquisition, jointly with the Joint Undertaking, of the mid-range EuroHPC supercomputers, less the contributions by the Joint Undertaking and any other Union contribution to those costs; (e) financial contributions by a consortium of private partners consisting of the costs incurred for the acquisition and operation, jointly with the Joint Undertaking, of the industrial-grade EuroHPC supercomputers, less the contributions by the Joint Undertaking and any other Union contribution to those costs, until their ownership is transferred to the hosting entity, they are sold or decommissioned in accordance with Article 13(6) of this Regulation; (f) financial contributions by Participating States to the eligible costs incurred by beneficiaries established in that Participating State, including the Union contributions that are considered to be contributions of the Participating State pursuant to Article 15(3) of Regulation (EU) 2021/695, in implementing indirect actions corresponding to the research and innovation agenda as a complement to the reimbursement of these costs made by the Joint Undertaking, less the contributions by the Joint Undertaking and any other Union contribution to those costs. Such contributions shall be without prejudice to state-aid rules; (g) in-kind contributions by the Private Members or their constituent entities and affiliated entities as defined in Article 9(7) of this Regulation. 4. The resources of the Joint Undertaking entered in its budget shall be composed of the following contributions: (a) Union financial contributions to the administrative costs; (b) members’ financial contributions to the operational costs; (c) any revenue generated by the Joint Undertaking; (d) any other financial contributions, resources and revenues; (e) any interest yielded by the contributions paid to the Joint Undertaking shall be considered to be its revenue. 5. Should any member of the Joint Undertaking be in default of its commitments concerning its financial contribution, the Executive Director shall put this in writing and shall set a reasonable period within which such default shall be remedied. If the situation is not remedied within that period, the Executive Director shall convene a meeting of the Governing Board to decide whether the defaulting member’s membership is to be revoked or whether any other measures are to be taken until its obligations have been met. The defaulting member’s voting rights shall be suspended until the default of its commitments is remedied. The Joint Undertaking or any of its members shall not be obliged to cover the defaulting members’ financial contribution. 6. The resources and activities of the Joint Undertaking shall be intended for the achievement of the objectives set out in Article 3 of this Regulation. 7. The Joint Undertaking shall own all assets generated by it or transferred to it for the achievement of its objectives set out in Article 3 of this Regulation. This shall not include the EuroHPC supercomputers whose ownership the Joint Undertaking has transferred to a hosting entity in accordance with Articles 11(5), 12(7), 13(6) and 14(6) of this Regulation. 8. Except when the Joint Undertaking is wound up, any excess revenue over expenditure shall not be paid to the members of the Joint Undertaking. Article 16 Financial commitments The financial commitments of the Joint Undertaking shall not exceed the amount of financial resources available or committed to its budget by its members. The Commission may provide multi-annual commitments. Article 17 Financial year The financial year shall run from 1 January to 31 December. Article 18 Operational and financial planning 1. The multiannual strategic programme shall specify the strategy and plans for achieving the objectives of the Joint Undertaking set out in Article 3 of this Regulation. It shall include the following: the acquisition of supercomputers; the research and innovation activities including the strategic research and innovation agenda; the capability building and widening activities; the federation, connectivity and international cooperation activities. It shall also include the multiannual financial perspectives received from the Participating States and the Commission. 2. Private Members shall draft the Strategic Research and Innovation Agenda and shall submit it to the Research and Innovation Advisory Group. 3. The Industrial and Scientific Advisory Board shall consolidate the multiannual strategic programme and submit it to the Executive Director. It shall be the basis for the Executive Director to draft the annual work programme. 4. The draft annual work programme shall include the research and innovation activities, the procurement activities, the capability building and widening activities, the federation and connectivity activities, the international cooperation activities, the administrative activities and the corresponding expenditure estimates for the following year. 5. The Executive Director shall submit to the Governing Board the administrative agreements referred to in Article 8(2) of this Regulation supporting the expenditure estimates. 6. The annual work programme shall be adopted by the end of the year prior to its implementation. The annual work programme shall be made publicly available. 7. The Executive Director shall prepare the draft annual budget for the following year and shall submit it to the Governing Board for adoption. 8. The annual budget for a particular year shall be adopted by the Governing Board by the end of the year prior to its implementation. 9. The annual budget shall be adapted in order to take into account the amount of the Union’s financial contribution as set out in the general budget of the Union. Article 19 Operational and financial reporting 1. The Executive Director shall report annually to the Governing Board on the performance of his or her duties in accordance with the financial rules of the Joint Undertaking referred to in Article 19 of this Regulation. The consolidated annual activity report shall include, inter alia, information on the following matters: (a) research, innovation and other actions carried out and the corresponding expenditure; (b) acquisition and operation of infrastructure, including the use of and access to the infrastructure, including the access time effectively used by each Participating State; (c) the proposals and tenders submitted, including a breakdown by participant type, including SMEs, and by country; (d) the indirect actions selected for funding, with a breakdown by participant type, including SMEs, and by country, and indicating the contributions of the Joint Undertaking to the individual participants and actions; (e) the tenders selected for funding, with a breakdown by type of contractor, including SMEs, and by country, and indicating the contributions of the Joint Undertaking to the individual contractors and procurement actions; (f) the outcome of the procurement activities; (g) progress towards the achievement of the objectives set out in Article 3 of this Regulation and proposals for further necessary work to achieve those objectives. 2. The accounting officer of the Joint Undertaking shall send the provisional accounts to the Commission’s accounting officer and the Court of Auditors in accordance with the financial rules of the Joint Undertaking. 3. The Executive Director shall send the report on the budgetary and financial management to the European Parliament, the Council and the Court of Auditors in accordance with the financial rules of the Joint Undertaking. 4. The discharge procedure shall be carried out in accordance with the financial rules of the Joint Undertaking. Article 20 Internal audit 1. The Commission’s internal auditor shall exercise the same powers over the Joint Undertaking as those exercised in respect of the Commission. 2. The Joint Undertaking shall be capable of performing its own internal audit. Article 21 Liability of members and insurance 1. The financial liability of the members of the Joint Undertaking for the debts of the Joint Undertaking shall be limited to their financial contributions made to the Joint Undertaking. 2. The Joint Undertaking shall take out and maintain appropriate insurance. Article 22 Conflict of interest 1. The Joint Undertaking, its bodies and staff shall avoid any conflict of interest in carrying out their activities. 2. The Governing Board shall adopt rules for the prevention and management of conflicts of interest in respect of the persons serving in the Governing Board and in the other bodies or groups of the Joint Undertaking. Article 23 Winding-up 1. The Joint Undertaking shall be wound up at the end of the period laid down in Article 1 of this Regulation. 2. In addition to paragraph 1, the winding-up procedure shall be automatically triggered if the Union or all members other than the Union withdraw from the Joint Undertaking. 3. For the purpose of conducting the proceedings to wind up the Joint Undertaking, the Governing Board shall appoint one or more liquidators, who shall comply with the decisions of the Governing Board. 4. When the Joint Undertaking is being wound up, its assets shall be used to cover its liabilities and the expenditure relating to its winding-up. The supercomputers owned by the Joint Undertaking shall be transferred to the respective hosting entities or consortium of private partners, sold or decommissioned upon decision of the Governing Board and in accordance with the hosting agreement. The members of the Joint Undertaking shall not be liable for any costs incurred after the transfer of ownership of a supercomputer or its sale or decommissioning. In the event of transfer of ownership, the hosting entity or the consortium of private partners shall reimburse the Joint Undertaking the residual value of the supercomputers that are transferred. Any surplus shall be distributed among the members at the time of the winding-up in proportion to their financial contribution to the Joint Undertaking. Any such surplus distributed to the Union shall be returned to the general budget of the Union. 5. An ad hoc procedure shall be set up to ensure the appropriate management of any agreement concluded or decision adopted by the Joint Undertaking, as well as any procurement contract with a duration longer than the duration of the Joint Undertaking. (1) Council Decision 2009/937/EU of 1 December 2009 adopting the Council’s Rules of Procedure (OJ L 325, 11.12.2009, p. 35).

European High-Performance Computing Joint Undertaking European High-Performance Computing Joint Undertaking SUMMARY OF: Regulation (EU) 2021/1173 establishing the European High-Performance Computing Joint Undertaking WHAT IS THE AIM OF THE REGULATION? As provided for in Article 187 of the Treaty on the Functioning of the European Union, in order to implement the European high-performance computing initiative, the regulation establishes the European High-Performance Computing Joint Undertaking (EuroHPC JU) between the European Union (EU), EU Member States and private partners, for a period until 31 December 2033. Its mission is to develop, deploy, extend and maintain a world-leading consolidated, secure and hyper-connected supercomputing*, quantum-computing*, service and data infrastructure ecosystem. KEY POINTS The regulation builds upon and repeals Regulation (EU) 2018/1488. Objectives and activities The joint undertaking aims to: deliver scientific, economic, environmental, technological and societal results from the EU’s investment in research and innovation; deliver on the EU’s strategic priorities and contribute to its objectives and policies; tackle global challenges, including the United Nations sustainable development goals, by following the principles of the United Nations sustainable development agenda 2030 and the Paris Agreement adopted under the United Nations framework convention on climate change; closely cooperate and coordinate with other European partnership and relevant programmes at EU, national, and regional level; develop, deploy and maintain a hyper-connected supercomputing and data infrastructure in the EU and federate it with European data spaces and a cloud ecosystem; promote scientific excellence and support the uptake and systematic use of research and innovation results generated in the EU; further develop and support a highly competitive and innovative supercomputing and data ecosystem to be broadly distributed in Europe, which contributes to the EU’s scientific and digital leadership, and which is capable of autonomously producing computing systems and advanced applications; widen the use of supercomputing services and develop key skills needed in European science and industry. Joint undertaking members The joint undertaking members are: the EU, represented by the European Commission; Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden; Montenegro, North Macedonia, Switzerland and Turkey, on the condition that they are associated with Horizon Europe, the Digital Europe programme or the Connecting Europe Facility; the European technology platform for high-performance computing (ETP4HPC) association (subject to EU endorsement); DAIRO — the Data, AI and Robotics Association, formerly known as the Big Data Value Association (BVDA) (subject to endorsement). Governance The governance structure comprises: a governing board, composed of representatives of the EU and participating countries, responsible for strategic policymaking and funding decisions; an industrial and scientific advisory board, with academic and industry representatives as users and technology suppliers, to provide independent advice to the governing board on the strategic research and innovation agenda and on acquiring and operating the supercomputers owned by the joint undertaking. Financial contribution The EU’s financial contribution to the joint undertaking, including European Economic Area (EEA) appropriations, is up to €3,081,300,000, including €92,000,000 for administration, on condition that it is matched by the contribution of participating countries, distributed as follows: Horizon Europe: up to €900,000,000; Digital Europe programme: up to €1,981,300,000; Connecting Europe Facility: up to €200,000,000. Private members of the joint undertaking must contribute at least €900,000,000. Acquisition and ownership of computer equipment The joint undertaking acquires the following elements under the regulation. High-end supercomputers, quantum computers and quantum simulators*, retaining ownership. The EU covers up to 50% of the acquisition costs plus up to 50% of the operating costs. The remaining total cost of ownership is covered by the participating state where the hosting company is established. Industrial-grade EuroHPC supercomputers, retaining ownership. The EU covers up to 35% of the acquisition costs plus up to 35% of the operating costs, the remainder covered by the consortium of private partners. Mid-range supercomputers, jointly with participating countries, with joint ownership. The EU covers up to 35% of the acquisition costs plus up to 35% of the operating costs. The remaining total cost of ownership is covered by the participating state where the hosting company is established. The joint undertaking may launch a call to upgrade the EuroHPC supercomputers it owns or co-owns. The maximum EU contribution to such upgrades may not exceed €150,000,000 for the period 2021–2027. FROM WHEN DOES THE REGULATION APPLY? It has applied since 8 August 2021 and covers the period up to 31 December 2033. BACKGROUND For more information, see: European technology platform for high-performance computing (ETP4HPC) (European Commission) Horizon Europe (European Commission) Digital Europe programme (European Commission) Connecting Europe Facility (European Commission). KEY TERMS Supercomputing. The term generally applied to mean the fastest high-performance systems available at any given time. Supercomputers are used primarily for scientific and engineering work requiring exceedingly high-speed computations. Quantum-computing. The study of how to use phenomena in quantum physics to create new ways of computing. Quantum computers perform calculations based on the probability of an object’s state before it is measured. Quantum simulators. Devices that actively use quantum effects to answer questions about model systems and, through them, real systems. MAIN DOCUMENT Council Regulation (EU) 2021/1173 of 13 July 2021 on establishing the European High Performance Computing Joint Undertaking and repealing Regulation (EU) 2018/1488 (OJ L 256, 19.7.2021, pp. 3–51). RELATED DOCUMENTS Regulation (EU) 2021/1153 of the European Parliament and of the Council of 7 July 2021 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014 (OJ L 249, 14.7.2021, pp. 38–81). Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, pp. 159–706). Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, pp. 1–34). Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe — the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, pp. 1–68). Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions — The European Green Deal (COM(2019) 640 final, 11.12.2019). Consolidated version of the Treaty on the Functioning of the European Union — Part Three — Union policies and internal actions — Title XIX — Research and technological development and space — Article 187 (ex Article 171 TEC) (OJ C 202, 7.6.2016, p. 131). last update 29.10.2021

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25.6.2019 EN Official Journal of the European Union L 169/1 REGULATION (EU) 2019/1020 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 33 and 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) In order to guarantee the free movement of products within the Union, it is necessary to ensure that products are compliant with Union harmonisation legislation and therefore fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, protection of consumers, protection of the environment, public security and protection of any other public interests protected by that legislation. Robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the Union market for goods can thrive. Rules are therefore necessary to ensure this enforcement, regardless of whether products are placed on the market via offline or online means and regardless of whether they are manufactured in the Union or not. (2) Union harmonisation legislation covers a large share of manufactured products. Non-compliant and unsafe products put citizens at risk, and might distort competition with economic operators selling compliant products within the Union. (3) Strengthening the single market for goods through further enhancing efforts to keep non-compliant products from being placed on the Union market was identified as a priority in the Communication from the Commission of 28 October 2015 entitled ‘Upgrading the Single Market: more opportunities for people and business’. This should be achieved by strengthening market surveillance, providing economic operators with clear, transparent and comprehensive rules, intensifying compliance controls and promoting closer cross-border cooperation among enforcement authorities, including through cooperation with customs authorities. (4) The framework for market surveillance established by this Regulation should complement and strengthen existing provisions in Union harmonisation legislation relating to the ensuring of compliance of products and the framework for cooperation with organisations representing economic operators or end users, the market surveillance of products and controls on those products entering the Union market. However, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in Union harmonisation legislation. The corresponding provisions of this Regulation should therefore not apply in the areas covered by such specific provisions, for instance those set out in Regulations (EC) No 1223/2009 (3), (EU) 2017/745 (4) and (EU) 2017/746 (5), including as regards the use of the European database on medical devices (EUDAMED), and (EU) 2018/858 (6) of the European Parliament and of the Council. (5) Directive 2001/95/EC of the European Parliament and of the Council (7) lays down the general safety requirements for all consumer products and provides for specific obligations and powers of the Member States in relation to dangerous products as well as for the exchange of information to that effect through the Rapid Information Exchange System (RAPEX). Market surveillance authorities should have the possibility of taking the more specific measures available to them under that Directive. In order to achieve a higher level of safety for consumer products, the mechanisms for exchanges of information and rapid intervention situations provided for in Directive 2001/95/EC should be made more effective. (6) The provisions on market surveillance of this Regulation should cover products that are subject to the Union harmonisation legislation listed in Annex I concerning manufactured products other than food, feed, medicinal products for human and veterinary use, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction. This will ensure a uniform framework for market surveillance of those products at Union level and will help to increase the confidence of consumers and other end users in products placed on the Union market. If new Union harmonisation legislation is adopted in the future, it will be for that legislation to specify whether this Regulation is also to apply to that legislation. (7) Articles 15 to 29 of Regulation (EC) No 765/2008 of the European Parliament and of the Council (8) laying down the Community market surveillance framework and controls of products entering the Community market should be deleted and the respective provisions should be replaced by this Regulation. That framework includes the provisions on controls of products entering the Community market, in Articles 27, 28 and 29 of Regulation (EC) No 765/2008, which apply not only to products covered by the market surveillance framework, but to all products in so far as other Union law does not contain specific provisions relating to the organisation of controls on products entering the Union market. It is therefore necessary that the scope of the provisions of this Regulation with regard to products entering the Union market extend to all products. (8) In order to rationalise and simplify the overall legislative framework, while simultaneously pursuing the objectives of Better Regulation, the rules applicable to controls on products entering the Union market should be revised and integrated into a single legislative framework for controls on products at the Union's external borders. (9) Responsibility for enforcing Union harmonisation legislation should lie with the Member States, and their market surveillance authorities should be required to ensure that the legislation is fully complied with. The Member States should, therefore, establish systematic approaches to ensure effectiveness of market surveillance and other enforcement activities. In this regard, the methodology and criteria for assessing risks should be further harmonised in all Member States in order to ensure a level playing field for all economic operators. (10) In order to assist market surveillance authorities to strengthen consistency in their activities related to the application of this Regulation, an effective peer review system should be established for those market surveillance authorities wishing to participate. (11) Certain definitions currently set out in Regulation (EC) No 765/2008 should be aligned with definitions set out in other Union legal acts and, where appropriate, reflect the architecture of modern supply chains. The definition of ‘manufacturer’ in this Regulation should not relieve manufacturers of any obligations they might have under Union harmonisation legislation where specific definitions of manufacturer are applied, which might cover any natural or legal person who modifies a product already placed on the market in such a way that compliance with the applicable Union harmonisation legislation might be affected and places it on the market, or any other natural or legal person who places a product on the market under its name or trade mark. (12) Economic operators throughout the entire supply chain should be expected to act responsibly and in full accordance with the legal requirements applicable when placing or making products available on the market, so as to ensure compliance with the Union harmonisation legislation on products. This Regulation should be without prejudice to the obligations corresponding to the roles of each of the economic operators in the supply and distribution process pursuant to specific provisions in Union harmonisation legislation, and the manufacturer should retain ultimate responsibility for compliance of the product with requirements of the Union harmonisation legislation. (13) The challenges of the global market and increasingly complex supply chains, as well as the increase of products that are offered for sale online to end users within the Union, call for the strengthening of enforcement measures, to ensure the safety of consumers. Furthermore, practical experience of market surveillance has shown that such supply chains sometimes involve economic operators whose novel form means that they do not fit easily into the traditional supply chains according to the existing legal framework. Such is the case, in particular, with fulfilment service providers, which perform many of the same functions as importers but which might not always correspond to the traditional definition of importer in Union law. In order to ensure that market surveillance authorities can carry out their responsibilities effectively and to avoid a gap in the enforcement system, it is appropriate to include fulfilment service providers within the list of economic operators against whom it is possible for market surveillance authorities to take enforcement measures. By including fulfilment service providers within the scope of this Regulation, market surveillance authorities will be better able to deal with new forms of economic activity in order to ensure the safety of consumers and the smooth functioning of the internal market, including where the economic operator acts both as an importer as regards certain products and as a fulfilment service provider as regards other products. (14) Modern supply chains encompass a wide variety of economic operators who should all be subject to enforcement of Union harmonisation legislation, while taking due consideration of their respective roles in the supply chain, and the extent to which they contribute to the making available of products on the Union market. Therefore, it is necessary to apply this Regulation to economic operators that are directly concerned by Union harmonisation legislation listed in Annex I to this Regulation, such as the producer of an article and the downstream user as defined in Regulation (EC) No 1907/2006 of the European Parliament and of the Council (9) and in Regulation (EC) No 1272/2008 of the European Parliament and of the Council (10), the installer as defined in Directive 2014/33/EU of the European Parliament and of the Council (11), the supplier as defined in Regulation (EC) No 1222/2009 of the European Parliament and of the Council (12) or the dealer as defined in Regulation (EU) 2017/1369 of the European Parliament and of the Council (13). (15) In the case of a product offered for sale online or through other means of distance sales, the product should be considered to have been made available on the market if the offer for sale is targeted at end users in the Union. In line with the applicable Union rules on private international law, a case-by-case analysis should be carried out in order to establish whether an offer is targeted at end users in the Union. An offer for sale should be considered to be targeted at end users in the Union if the relevant economic operator directs, by any means, its activities to a Member State. For the case-by-case analyses, relevant factors, such as the geographical areas to which dispatch is possible, the languages available, used for the offer or for ordering, or means of payment, need to be taken into consideration. In the case of online sales, the mere fact that the economic operators' or the intermediaries' website is accessible in the Member State in which the end user is established or domiciled is insufficient. (16) The development of e-commerce is also due, to a great extent, to the proliferation of information society service providers, usually through platforms and for remuneration, which offer intermediary services by storing third party content, without exercising control over that content, and therefore not acting on behalf of an economic operator. Removal of content regarding non-compliant products or, where this is not feasible, restricting access to non-compliant products offered through their services should be without prejudice to the rules laid down in Directive 2000/31/EC of the European Parliament and of the Council (14). In particular, no general obligation should be imposed on information society service providers to monitor the information which they transmit or store, nor should a general obligation be imposed upon them to actively seek facts or circumstances indicating illegal activity. Furthermore, hosting service providers should not be held liable as long as they do not have actual knowledge of illegal activity or information and are not aware of the facts or circumstances from which the illegal activity or information is apparent. (17) While this Regulation does not deal with the protection of intellectual property rights, it should nevertheless be borne in mind that often counterfeit products do not comply with the requirements set out in the Union harmonisation legislation, present risks to health and safety of end users, distort competition, endanger public interests and support other illegal activities. Therefore, Member States should continue taking effective measures to prevent counterfeit products from entering the Union market pursuant to Regulation (EU) No 608/2013 of the European Parliament and of the Council (15). (18) A fairer single market should ensure equal conditions for competition to all economic operators and protection against unfair competition. To this end, strengthened enforcement of Union harmonisation legislation on products is necessary. Good cooperation between manufacturers and the market surveillance authorities is a key element, allowing immediate intervention and corrective action in relation to the product. It is important that, for certain products, there should be an economic operator established in the Union so that market surveillance authorities have someone to whom requests can be addressed, including requests for information regarding a product's compliance with Union harmonisation legislation, and who can cooperate with market surveillance authorities in making sure that immediate corrective action is taken to remedy instances of non-compliance. The economic operators who should perform those tasks are the manufacturer, or the importer when the manufacturer is not established in the Union, or an authorised representative mandated by the manufacturer for this purpose, or a fulfilment service provider established in the Union for products handled by it when no other economic operator is established in the Union. (19) The development of e-commerce poses certain challenges for market surveillance authorities with regard to the ensuring of compliance of products offered for sale online and the effective enforcement of Union harmonisation legislation. The number of economic operators offering products directly to consumers by electronic means is increasing. Therefore, economic operators with tasks regarding products subject to certain Union harmonisation legislation perform an essential role by providing market surveillance authorities with an interlocutor established in the Union, and by performing specific tasks in a timely manner to make sure that the products comply with the requirements of Union harmonisation legislation, for the benefit of consumers, other end users and businesses within the Union. (20) The obligations of the economic operator with tasks regarding products subject to certain Union harmonisation legislation should be without prejudice to existing obligations and responsibilities of manufacturer, importer and authorised representative under the relevant Union harmonisation legislation. (21) Obligations of this Regulation requiring an economic operator to be established in the Union in order to place products on the Union's market should only apply to areas where the need for an economic operator to act as a liaison point with the market surveillance authorities has been identified, taking into account a risk-based approach, having regard to the principle of proportionality, and taking into account high level of protection of end users in the Union. (22) Moreover, those obligations should not apply where the specific requirements set out in certain legal acts on products achieve in effect the same result, namely Regulation (EC) No 648/2004 of the European Parliament and of the Council (16), Regulation (EC) No 1223/2009, Regulation (EU) No 167/2013 of the European Parliament and of the Council (17), Regulation (EU) No 168/2013 of the European Parliament and of the Council (18), Directive 2014/28/EU of the European Parliament and of the Council (19), Directive 2014/90/EU of the European Parliament and of the Council (20), Regulation (EU) 2016/1628 of the European Parliament and of the Council (21), Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) 2017/1369 and Regulation (EU) 2018/858. Consideration should also be given to situations where potential risks or cases of non-compliance are low, or in which products are mainly traded through traditional supply chains, which is the case, for instance, for Directive 2014/33/EU, Regulation (EU) 2016/424 of the European Parliament and of the Council (22) and Directive 2010/35/EU of the European Parliament and of the Council (23). (23) Contact information of economic operators with tasks regarding products subject to certain Union harmonisation legislation should be indicated with the product in order to facilitate checks throughout the supply chain. (24) Economic operators should fully cooperate with market surveillance authorities and other competent authorities to ensure the smooth performance of market surveillance and to enable the authorities to perform their tasks. This includes, where requested by authorities, providing the contact information of the economic operators with tasks regarding products subject to certain Union harmonisation legislation where this information is available to them. (25) Economic operators should have easy access to high quality, comprehensive information. Since the single digital gateway established under Regulation (EU) 2018/1724 of the European Parliament and of the Council (24) provides for a single point of online access to information, it can be used in respect to providing relevant information on Union harmonisation legislation to economic operators. Nevertheless, Member States should put in place procedures for ensuring access to the Product Contact Points established under Regulation (EU) 2019/515 of the European Parliament and of the Council (25) in order to assist the economic operators in addressing properly their requests for information. Guidance on issues relating to technical specifications or harmonised standards or design of a specific product should not be part of the obligations of Member States when providing such information. (26) Market surveillance authorities might carry out joint activities with other authorities or organisations representing economic operators or end users, with a view to promoting compliance, identifying non-compliance, raising awareness and providing guidance on Union harmonisation legislation and with respect to specific categories of products, including those that are offered for sale online. (27) Member States should designate their own market surveillance authorities. This Regulation should not prevent Member States from choosing the competent authorities to carry out the market surveillance tasks. In order to facilitate administrative assistance and cooperation, Member States should also appoint a single liaison office. Single liaison offices should at least represent the coordinated position of the market surveillance authorities and the authorities in charge of the control on products entering the Union market. (28) E-commerce poses certain challenges for market surveillance authorities regarding the protection of the health and safety of end users from non-compliant products. Therefore, Member States should ensure their market surveillance is organised with the same effectiveness for products made available online as it is for products made available offline. (29) While performing market surveillance of products offered for sale online, market surveillance authorities are facing numerous difficulties, such as tracing products offered for sale online, identifying the responsible economic operators, or conducting risk-assessments or tests due to the lack of physical access to products. In addition to the requirements introduced by this Regulation, Member States are encouraged to use complementary guidance and best practices for market surveillance and for communication with businesses and consumers. (30) Special attention should be given to emerging technologies, taking into account that consumers are increasingly using connected devices in their daily lives. The Union regulatory framework should therefore address the new risks to ensure the safety of the end users. (31) In the age of constant development of digital technologies new solutions that could contribute to the effective market surveillance within the Union should be explored. (32) Market surveillance should be thorough and effective, to ensure that Union harmonisation legislation on products is applied correctly. Given that controls may represent a burden for economic operators, market surveillance authorities should organise and conduct inspection activities on a risk-based approach, taking the interests of those economic operators into account and limiting the said burden to what is necessary for the performance of efficient and effective controls. Furthermore, market surveillance should be performed with the same level of care by the competent authorities of the Member State irrespective of whether non-compliance of the given product is relevant on the territory of that Member State or is likely to have an impact on the market of another Member State. Uniform conditions for certain inspection activities carried out by the market surveillance authorities where products or categories of products present specific risks or seriously breach the applicable Union harmonisation legislation might be laid down by the Commission. (33) Market surveillance authorities, when performing their duties, are confronted with different shortcomings in terms of resources, coordination mechanisms, as well as powers with regard to non-compliant products. Such differences lead to fragmented enforcement of Union harmonisation legislation and to market surveillance being more rigorous in some Member States than in others, potentially compromising the level playing field among businesses and creating also potential imbalances in the level of product safety throughout the Union. (34) In order to ensure that the Union harmonisation legislation on products is correctly enforced, market surveillance authorities should have a common set of investigative and enforcement powers, allowing for enhanced cooperation between market surveillance authorities and more effective deterrence for economic operators that willingly infringe Union harmonisation legislation. Those powers should be sufficiently robust to tackle the enforcement challenges of Union harmonisation legislation, along with the challenges of e-commerce and the digital environment and to prevent economic operators from exploiting gaps in the enforcement system by relocating to Member States whose market surveillance authorities are not equipped to tackle unlawful practices. In particular, the powers should ensure that information and evidence can be exchanged between competent authorities so that enforcement can be undertaken equally in all Member States. (35) This Regulation should be without prejudice to the freedom of Member States to choose the enforcement system that they consider to be appropriate. Member States should be free to choose whether their market surveillance authorities can exercise investigation and enforcement directly under their own authority, by recourse to other public authorities or upon application to the competent courts. (36) Market surveillance authorities should be in a position to open investigations on their own initiative if they become aware of non-compliant products placed on the market. (37) Market surveillance authorities should have access to all necessary evidence, data and information relating to the subject matter of an investigation in order to determine whether applicable Union harmonisation legislation has been infringed, and in particular to identify the economic operator responsible, irrespective of who possesses the evidence, data or information in question and regardless of where it is located and of the format in which it is held. Market surveillance authorities should be able to request economic operators, including those in the digital value chain, to provide all the evidence, data and information necessary. (38) Market surveillance authorities should be able to carry out the necessary on-site inspections, and should have the power to enter any premises, land or means of transport, that the economic operator uses for purposes relating to its trade, business, craft or profession. (39) Market surveillance authorities should be able to require a representative or a relevant member of staff of the economic operator concerned to give explanations or provide facts, information or documents relating to the subject matter of the on-site inspection, and to record the answers given by that representative or relevant member of staff. (40) Market surveillance authorities should be able to check the compliance of products to be made available on the market with Union harmonisation legislation and to obtain evidence of non-compliance. They should, therefore, have the power to acquire products and, where the evidence cannot be obtained by other means, to purchase products under a cover identity. (41) In the digital environment in particular, market surveillance authorities should be able to bring non-compliance to an end quickly and effectively, notably where the economic operator selling the product conceals its identity or relocates within the Union or to a third country in order to avoid enforcement. In cases where there is a risk of serious and irreparable harm to end users due to non-compliance, market surveillance authorities should be able to take measures, where duly justified and proportionate and where there are no other means available to prevent or mitigate such harm, including, where necessary, requiring the removal of content from the online interface or the display of a warning. When such a request is not observed, the relevant authority should have the power to require information society service providers to restrict access to the online interface. These measures should be taken in accordance with the principles laid down in Directive 2000/31/EC. (42) The implementation of this Regulation and the exercise of powers in its application should also comply with other Union and national law, for example Directive 2000/31/EC, including with applicable procedural safeguards and principles of the fundamental rights. That implementation and that exercise of powers should also be proportionate and adequate in view of the nature and the overall actual or potential harm caused by the infringement. Competent authorities should take all facts and circumstances of the case into account and should choose the most appropriate measures, namely, those which are essential to address the infringement covered by this Regulation. Those measures should be proportionate, effective and dissuasive. Member States should remain free to set out conditions and limits for the exercise of the powers to fulfil duties in national law. Where, for example, in accordance with national law, prior authorisation to enter the premises of natural persons and legal persons is required from the judicial authority of the Member State concerned, the power to enter such premises should be used only after such prior authorisation has been obtained. (43) Market surveillance authorities act in the interest of economic operators, of end users, and of the public, to ensure that public interests covered by relevant Union harmonisation legislation on products are consistently preserved and protected through appropriate enforcement measures, and that compliance with such legislation is ensured across the supply chain through appropriate checks, taking into consideration the fact that administrative checks alone, in many cases, cannot replace physical and laboratory checks in order to verify the compliance of products with the relevant Union harmonisation legislation. Consequently, market surveillance authorities should ensure a high level of transparency while performing their activities and should make available to the public any information that they consider to be relevant in order to protect the interests of end users in the Union. (44) This Regulation should be without prejudice to the functioning of RAPEX in accordance with Directive 2001/95/EC. (45) This Regulation should be without prejudice to the safeguard clause procedure provided for by sectoral Union harmonisation legislation, pursuant to Article 114(10) of the Treaty on the Functioning of the European Union. With a view to ensuring an equivalent level of protection throughout the Union, Member States are authorised to take measures in relation to products presenting a risk to health and safety, or other aspects of public interest protection. They are also required to notify those measures to other Member States and the Commission, allowing the Commission to take a position on whether national measures that restrict the free movement of products with a view to ensuring the functioning of the internal market are justified. (46) The exchange of information between market surveillance authorities, and the use of evidence and investigation findings should respect the principle of confidentiality. Information should be handled in accordance with applicable national law, in order to ensure that investigations are not compromised and that the reputation of the economic operator is not prejudiced. (47) Where, for the purposes of this Regulation, it is necessary to process personal data, this should be carried out in accordance with Union law on the protection of personal data. Any processing of personal data under this Regulation is subject to Regulation (EU) 2016/679 of the European Parliament and of the Council (26) and Regulation (EU) 2018/1725 of the European Parliament and of the Council (27), as applicable. (48) To ensure the effectiveness and consistency of testing across the Union in the market surveillance framework with regard to specific products or a specific category or group of products or for specific risks related to a category or group of products, the Commission might designate testing facilities of its own or public testing facilities of a Member State as a Union testing facility. All Union testing facilities should be accredited in accordance with the requirements of Regulation (EC) No 765/2008. In order to avoid conflicts of interests, Union testing facilities should only provide services to market surveillance authorities, the Commission, the Union Product Compliance Network (the ‘Network’) and other government or intergovernmental entities. (49) Member States should ensure that adequate financial resources are always available for the appropriate staffing and equipping of the market surveillance authorities. Efficient market surveillance is demanding in terms of resources, and stable resources should be provided at a level appropriate to the enforcement needs at any given moment. Member States should have the possibility to supplement public financing by reclaiming from the relevant economic operators the costs incurred when performing market surveillance in relation to products that were found to be non-compliant. (50) Mechanisms for mutual assistance should be established, since it is imperative for the Union market for goods that the market surveillance authorities of the Member States cooperate with each other effectively. Authorities should act in good faith and, as a general principle, accept requests for mutual assistance, in particular those concerning access to EU declaration of conformity, declaration of performance and technical documentation. (51) It is appropriate that Member States designate the authorities responsible for applying the customs legislation and any other authorities in charge under national law of control on products entering the Union market. (52) An effective way to ensure that unsafe or non-compliant products are not placed on the Union market would be to detect such products before they are released for free circulation. Authorities in charge of the control on products entering the Union market have a complete overview of trade flows across the Union's external borders and should therefore be required to carry out adequate controls on a risk assessment basis to contribute to a safer market place which ensures a high level of protection of public interests. It is for Member States to designate the specific authorities that are to be responsible for the appropriate documentary and, where necessary, physical or laboratory checks of products before those products are released for free circulation. A uniform enforcement of Union harmonisation legislation on products can only be achieved through systematic cooperation and exchange of information between market surveillance and other authorities designated as authorities in charge of the control on products entering the Union market. These authorities should receive well in advance from the market surveillance authorities all the necessary information concerning non-compliant products or information on economic operators where a higher risk of non-compliance has been identified. In turn, authorities in charge of the control on products entering the customs territory of the Union should inform the market surveillance authorities in a timely manner of the release of products for free circulation, and the results of controls, where such information is relevant for the enforcement of Union harmonisation legislation on products. Furthermore, where the Commission becomes aware of a serious risk presented by an imported product, it should inform the Member States about that risk in order to ensure coordinated and more effective compliance and enforcement controls at the first points of entry to the Union. (53) Importers should be reminded that Articles 220, 254, 256, 257 and 258 of Regulation (EU) No 952/2013 of the European Parliament and of the Council (28) provide that products entering the Union market that require further processing in order to be in compliance with the applicable Union harmonisation legislation shall be placed under the appropriate customs procedure allowing such processing by the importer. Generally, the release for free circulation should not be deemed to be proof of conformity with Union law, since such a release does not necessarily include a complete check of compliance. (54) In order to use the EU Single Window environment for customs and therefore to optimise and unburden the data transfer between customs and market surveillance authorities, it is necessary to set up electronic interfaces that allow automatic data transfer. Customs and market surveillance authorities should contribute to determine the data to be transmitted. Additional burden for customs authorities should be limited and the interfaces should be highly automated and easy-to-use. (55) It is necessary to establish the Network, hosted by the Commission, aimed at structured coordination and cooperation between enforcement authorities of the Member States and the Commission, and at streamlining the practices of market surveillance within the Union that facilitate the implementation of joint enforcement activities by Member States, such as joint investigations. This administrative support structure should allow the pooling of resources and maintain a communication and information system between Member States and the Commission, thereby helping to strengthen enforcement of Union harmonisation legislation on products and to deter infringements. The involvement of administrative cooperation groups (ADCOs) in the Network should not preclude the involvement of other, similar, groups involved in administrative cooperation. The Commission should provide the necessary administrative and financial support to the Network. (56) There should be effective, speedy and accurate exchange of information among the Member States and the Commission. A number of existing tools, such as the information and communication system for market surveillance (ICSMS) and RAPEX enable coordination among market surveillance authorities in the Union. These tools, together with the interface permitting data transfer from ICSMS into RAPEX should be maintained and further developed in order to exploit their full potential and help to increase the level of cooperation and exchange of information between Member States and the Commission. (57) In that context, for the purpose of collecting information relating to the enforcement of Union harmonisation legislation on products, ICSMS should be upgraded and be accessible to the Commission, single liaison offices, customs and market surveillance authorities. Furthermore, an electronic interface should be developed to allow effective exchange of information between national systems of customs and market surveillance authorities. With regard to the cases of mutual assistance requests, the single liaison offices should give any support necessary for cooperation between the relevant authorities. Therefore, ICSMS should provide the functions enabling an automated indication to the single liaison offices when deadlines are not met. When sectoral legislation already provides for electronic systems for cooperation and data exchange, as is the case for example of EUDAMED for medical devices, those systems should be kept in use, when appropriate. (58) In general, ICSMS should be used to exchange information considered helpful for other market surveillance authorities. This might include checks undertaken in the context of market surveillance projects, regardless of the outcome of the tests. The amount of data to be entered in ICSMS should strike a balance between imposing too great a burden, when the efforts for entering the data would exceed the work involved in doing the actual checks, and being comprehensive enough to support greater efficiency and effectiveness on the side of the authorities. Thus, the data entered in ICSMS should also cover simpler checks than laboratory tests only. Nevertheless, there should be no need to include brief visual checks. As a guideline, checks which are individually documented should also be entered in ICSMS. (59) Member States are encouraged to use ICSMS for interactions between customs and market surveillance authorities as an alternative to the national systems. This should not replace the Community Risk Management System (CRMS) used by customs authorities. These two systems could work in parallel since they fulfil different, complementary roles, with ICSMS facilitating communication between customs and market surveillance authorities in order to allow for a smooth treatment of customs declarations in the scope of the product safety and compliance framework while CRMS is for customs common risk management and controls. (60) Injuries caused by non-compliant products are important information for market surveillance authorities. ICSMS should therefore provide for related data fields so that market surveillance authorities can enter readily available reports provided for in the course of their investigations, thus facilitating later statistical evaluations. (61) The Commission should be able to exchange market surveillance related information with regulatory authorities of third countries or international organisations within the framework of agreements concluded between the Union and third countries or international organisations, with a view to ensuring compliance of products prior to their export to the Union market. (62) In order to achieve a high degree of compliance with applicable Union harmonisation legislation on products while at the same time ensuring an effective resource-allocation and a cost-efficient control of products entering the Union market, the Commission should be able to approve specific pre-export control systems. Products falling under such approved systems might, as part of the risk assessment performed by authorities in charge of controls on products entering the Union market, benefit from a higher level of confidence than comparable products which have not been subject to a pre-export control. (63) The Commission should carry out an evaluation of this Regulation in light of the objective it pursues, and taking into consideration new technological, economic, commercial and legal developments. Pursuant to point 22 of the Interinstitutional Agreement of 13 April 2016 on Better L aw Making (29), the evaluation, based on efficiency, effectiveness, relevance, coherence and value added, should provide the basis for impact assessments of options for further action, particularly as regards the scope of this Regulation, the application and enforcement of the provisions related to the tasks of economic operators placing products on the market, and the system of product-related pre-export controls. (64) The financial interests of the Union should be protected through proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties. (65) The diversity of sanctions across the Union is one of the main reasons for inadequate deterrence and uneven protection. Rules on establishing sanctions, including monetary penalties, are a matter of national jurisdiction and should, therefore, be determined by national law. (66) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in relation to: determining the uniform conditions for checks, criteria for determination of the frequency of checks and amount of samples to be checked in relation to certain products or categories of products, where specific risks or serious breaches of Union harmonisation legislation have been continuously identified; specifying the procedures for the designation of Union testing facilities; laying down benchmarks and techniques for checks on the basis of common risk analysis at the Union level; specifying the details of statistical data covering controls performed by the designated authorities with respect to products subject to Union law; specifying the details of implementation arrangements for the information and communication system and defining the data relating to the placing of products under the customs procedure ‘release for free circulation’ transmitted by customs authorities; and to the approval of specific systems of product-related pre-export controls and the withdrawal of such approvals. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (30). (67) Since the objective of this Regulation, namely to improve the functioning of the internal market by strengthening the market surveillance of products covered by Union harmonisation legislation, cannot be sufficiently achieved by the Member States given the need for a very high degree of cooperation, interaction and coherent action of all of the competent authorities in all Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (68) This Regulation respects fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and present in the constitutional traditions of Member States. Accordingly, this Regulation should be interpreted and applied in accordance with those rights and principles, including those related to the freedom and pluralism of the media. In particular, this Regulation seeks to ensure full respect for consumer protection, the freedom to conduct a business, the freedom of expression and information, the right to property and the protection of personal data, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter 1. The objective of this Regulation is to improve the functioning of the internal market by strengthening the market surveillance of products covered by the Union harmonisation legislation referred to in Article 2, with a view to ensuring that only compliant products that fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, the protection of consumers, the protection of the environment and public security and any other public interests protected by that legislation, are made available on the Union market. 2. This Regulation lays down rules and procedures for economic operators regarding products subject to certain Union harmonisation legislation and establishes a framework for cooperation with economic operators. 3. This Regulation also provides a framework for controls on products entering the Union market. Article 2 Scope 1. This Regulation shall apply to products that are subject to the Union harmonisation legislation listed in Annex I (‘Union harmonisation legislation’), in so far as there are no specific provisions with the same objective in the Union harmonisation legislation, which regulate in a more specific manner particular aspects of market surveillance and enforcement. 2. Articles 25 to 28 shall apply to products covered by Union law in so far as there are no specific provisions relating to the organisation of controls on products entering the Union market in Union law. 3. The application of this Regulation shall not prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC. 4. This Regulation is without prejudice to Articles 12 to 15 of Directive 2000/31/EC. Article 3 Definitions For the purposes of this Regulation, the following definitions shall apply: (1) ‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (2) ‘placing on the market’ means the first making available of a product on the Union market; (3) ‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in the applicable Union harmonisation legislation and to ensure protection of the public interest covered by that legislation; (4) ‘market surveillance authority’ means an authority designated by a Member State under Article 10 as responsible for carrying out market surveillance in the territory of that Member State; (5) ‘applicant authority’ means the market surveillance authority that makes a request for mutual assistance; (6) ‘requested authority’ means the market surveillance authority that receives a request for mutual assistance; (7) ‘non-compliance’ means any failure to comply with any requirement under the Union harmonisation legislation or under this Regulation; (8) ‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark; (9) ‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market; (10) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market; (11) ‘fulfilment service provider’ means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council (31), parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council (32), and any other postal services or freight transport services; (12) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation or under the requirements of this Regulation; (13) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation; (14) ‘information society service provider’ means a provider of a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council (33); (15) ‘online interface’ means any software, including a website, part of a website or an application, that is operated by or on behalf of an economic operator, and which serves to give end users access to the economic operator's products; (16) ‘corrective action’ means any action taken by an economic operator to bring any non-compliance to an end where required by a market surveillance authority or on the economic operator's own initiative; (17) ‘voluntary measure’ means a corrective action where not required by a market surveillance authority; (18) ‘risk’ means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm; (19) ‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, protection of consumers, the environment, public security and other public interests, protected by the applicable Union harmonisation legislation, to a degree which goes beyond that considered reasonable and acceptable in relation to its intended purpose or under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements; (20) ‘product presenting a serious risk’ means a product presenting a risk, for which, based on a risk assessment and taking into account the normal and foreseeable use of the product, the combination of the probability of occurrence of a hazard causing harm and the degree of severity of the harm is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the risk are not immediate; (21) ‘end user’ means any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities; (22) ‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user; (23) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market; (24) ‘customs authorities’ means customs authorities as defined in point 1 of Article 5 of Regulation (EU) No 952/2013; (25) ‘release for free circulation’ means the procedure laid down in Article 201 of Regulation (EU) No 952/2013; (26) ‘products entering the Union market’ means products from third countries intended to be placed on the Union market or intended for private use or consumption within the customs territory of the Union and placed under the customs procedure ‘release for free circulation’. CHAPTER II TASKS OF ECONOMIC OPERATORS Article 4 Tasks of economic operators regarding products subject to certain Union harmonisation legislation 1. Notwithstanding any obligations set out in applicable Union harmonisation legislation, a product subject to legislation referred to in paragraph 5 may be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in paragraph 3 in respect of that product. 2. For the purposes of this Article, the economic operator referred to in paragraph 1 means any of the following: (a) a manufacturer established in the Union; (b) an importer, where the manufacturer is not established in the Union; (c) an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in paragraph 3 on the manufacturer's behalf; (d) a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in points (a), (b) and (c) is established in the Union. 3. Without prejudice to any obligations of economic operators under the applicable Union harmonisation legislation, the economic operator referred to in paragraph 1 shall perform the following tasks: (a) if the Union harmonisation legislation applicable to the product provides for an EU declaration of conformity or declaration of performance and technical documentation, verifying that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up, keeping the declaration of conformity or declaration of performance at the disposal of market surveillance authorities for the period required by that legislation and ensuring that the technical documentation can be made available to those authorities upon request; (b) further to a reasoned request from a market surveillance authority, providing that authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority; (c) when having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof; (d) cooperating with the market surveillance authorities, including following a reasoned request making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance with the requirements set out in Union harmonisation legislation applicable to the product in question, or, if that is not possible, to mitigate the risks presented by that product, when required to do so by the market surveillance authorities or on its own initiative, where the economic operator referred to in paragraph 1 considers or has reason to believe that the product in question presents a risk. 4. Without prejudice to the respective obligations of economic operators under the applicable Union harmonisation legislation, the name, registered trade name or registered trade mark, and contact details, including the postal address, of the economic operator referred to in paragraph 1 shall be indicated on the product or on its packaging, the parcel or an accompanying document. 5. This Article only applies in relation to products that are subject to Regulations (EU) No 305/2011 (34), (EU) 2016/425 (35) and (EU) 2016/426 (36) of the European Parliament and of the Council, and Directives 2000/14/EC (37), 2006/42/EC (38), 2009/48/EC (39), 2009/125/EC (40), 2011/65/EU (41), 2013/29/EU (42), 2013/53/EU (43), 2014/29/EU (44), 2014/30/EU (45), 2014/31/EU (46), 2014/32/EU (47), 2014/34/EU (48), 2014/35/EU (49), 2014/53/EU (50) and 2014/68/EU (51) of the European Parliament and of the Council. Article 5 Authorised representative 1. For the purposes of point (c) of Article 4(2), the authorised representative shall be mandated by the manufacturer to perform the tasks listed in Article 4(3), notwithstanding any other tasks mandated under the relevant Union harmonisation legislation. 2. The authorised representative shall perform the tasks specified in the mandate. It shall provide a copy of the mandate to the market surveillance authorities upon request, in a Union language determined by the market surveillance authority. 3. Authorised representatives shall have the appropriate means to be able to fulfil their tasks. Article 6 Distance sales Products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at end users in the Union. An offer for sale shall be considered to be targeted at end users in the Union if the relevant economic operator directs, by any means, its activities to a Member State. Article 7 Obligation of cooperation 1. Economic operators shall cooperate with market surveillance authorities regarding actions which could eliminate or mitigate risks that are presented by products made available on the market by those operators. 2. Information society service providers shall cooperate with the market surveillance authorities, at the request of the market surveillance authorities and in specific cases, to facilitate any action taken to eliminate or, if that is not possible, to mitigate the risks presented by a product that is or was offered for sale online through their services. CHAPTER III ASSISTANCE TO AND COOPERATION WITH ECONOMIC OPERATORS Article 8 Information to economic operators 1. The Commission, in accordance with Regulation (EU) 2018/1724, shall ensure that the Your Europe portal provides users with easy online access to information about the product requirements and rights, obligations and rules derived from the Union harmonisation legislation. 2. Member States shall put in place procedures for providing economic operators, at their request and free of charge, with information with respect to the national transposition and implementation of Union harmonisation legislation applicable to products. For this purpose, Article 9(1), (4) and (5) of Regulation (EU) 2019/515 shall apply. Article 9 Joint activities to promote compliance 1. Market surveillance authorities may agree with other relevant authorities or with organisations representing economic operators or end users on the carrying out of joint activities that have the aim of promoting compliance, identifying non-compliance, raising awareness and providing guidance in relation to the Union harmonisation legislation with respect to specific categories of products, in particular categories of products that are often found to present a serious risk, including products offered for sale online. 2. The market surveillance authority in question and the parties referred to in paragraph 1 shall ensure that the agreement on joint activities does not lead to unfair competition between economic operators and does not affect the objectivity, independence and impartiality of the parties. 3. A market surveillance authority may use any information resulting from joint activities carried out as part of any investigation regarding non-compliance that it undertakes. 4. The market surveillance authority in question shall make the agreement on joint activities, including the names of the parties involved, available to the public and shall enter that agreement in the information and communication system referred to in Article 34. At the request of a Member State, the Network established under Article 29 shall assist in the drawing up of the agreement on joint activities. CHAPTER IV ORGANISATION, ACTIVITIES AND OBLIGATIONS OF MARKET SURVEILLANCE AUTHORITIES AND THE SINGLE LIAISON OFFICE Article 10 Designation of market surveillance authorities and the single liaison office 1. Member States shall organise and carry out market surveillance as provided for in this Regulation. 2. For the purposes of paragraph 1 of this Article, each Member State shall designate one or more market surveillance authorities in its territory. Each Member State shall inform the Commission and the other Member States of its market surveillance authorities and the areas of competence of each of those authorities, using the information and communication system referred to in Article 34. 3. Each Member State shall appoint a single liaison office. 4. The single liaison office shall at least be responsible for representing the coordinated position of the market surveillance authorities and the authorities designated under Article 25(1) and for communicating the national strategies as set out in Article 13. The single liaison office shall also assist in the cooperation between market surveillance authorities in different Member States, as set out in Chapter VI. 5. In order to carry out market surveillance of products made available online and offline with the same effectiveness for all distribution channels, Member States shall ensure that their market surveillance authorities and single liaison office have the necessary resources, including sufficient budgetary and other resources, such as a sufficient number of competent personnel, expertise, procedures and other arrangements for the proper performance of their duties. 6. Where there is more than one market surveillance authority in their territory, Member States shall ensure that the respective duties of those authorities are clearly defined and that appropriate communication and coordination mechanisms are established to enable those authorities to collaborate closely and exercise their duties effectively. Article 11 Activities of market surveillance authorities 1. Market surveillance authorities shall conduct their activities in order to ensure the following: (a) effective market surveillance within their territory of products made available online and offline with respect to products that are subject to Union harmonisation legislation; (b) the taking by economic operators of appropriate and proportionate corrective action in relation to compliance with that legislation and this Regulation; (c) the taking of appropriate and proportionate measures where the economic operator fails to take corrective action. 2. Market surveillance authorities shall exercise their powers and carry out their duties independently, impartially and without bias. 3. Market surveillance authorities, as part of their activities set out in paragraph 1 of this Article, shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks based on adequate samples, prioritising their resources and actions to ensure effective market surveillance and taking into account the national market surveillance strategy referred to in Article 13. In deciding on which checks to perform, on which types of products and on what scale, market surveillance authorities shall follow a risk-based approach taking into account the following factors: (a) possible hazards and non-compliance associated with the products and, where available, their occurrence on the market; (b) activities and operations under the control of the economic operator; (c) the economic operator's past record of non-compliance; (d) if relevant, the risk profiling performed by the authorities designated under Article 25(1); (e) consumer complaints and other information received from other authorities, economic operators, media and other sources that might indicate non-compliance. 4. The Commission, after consulting the Network, may adopt implementing acts determining the uniform conditions of checks, criteria for determination of the frequency of checks and amount of samples to be checked in relation to certain products or categories of products, where specific risks or serious breaches of applicable Union harmonisation legislation have been continuously identified, in order to ensure high level of protection of health and safety or other public interests protected by that legislation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). 5. Where economic operators present test reports or certificates attesting the conformity of their products with Union harmonisation legislation issued by a conformity assessment body accredited in accordance with Regulation (EC) No 765/2008, market surveillance authorities shall take due account of those reports or certificates. 6. Evidence that is used by a market surveillance authority in one Member State may be used as part of investigations to verify product compliance carried out by market surveillance authorities in another Member State, without any further formal requirements. 7. Market surveillance authorities shall establish the following procedures in connection with products subject to the Union harmonisation legislation: (a) procedures for following up on complaints or reports on issues relating to risks or non-compliance; (b) procedures for verifying that the corrective action that was to be taken by economic operators has been taken. 8. With a view to ensuring communication and coordination with their counterparts in other Member States, market surveillance authorities shall actively participate in administrative cooperation groups (ADCOs) as referred to in Article 30(2). 9. Without prejudice to any Union safeguard procedure pursuant to the applicable Union harmonisation legislation, products that have been deemed to be non-compliant on the basis of a decision of a market surveillance authority in one Member State shall be presumed to be non-compliant by market surveillance authorities in other Member States, unless a relevant market surveillance authority in another Member State concluded the contrary on the basis of its own investigation, taking into account the input, if any, provided by an economic operator. Article 12 Peer reviews 1. Peer reviews shall be organised for market surveillance authorities wishing to participate in such reviews, in order to strengthen consistency in market surveillance activities in relation to the application of this Regulation. 2. The Network shall develop the methodology and the rolling plan for peer reviews among participating market surveillance authorities. When establishing the methodology and the rolling plan, the Network shall take into consideration, at least, the number and the size of market surveillance authorities in the Member States, the number of personnel available and other resources for performing the peer review, and other relevant criteria. 3. Peer reviews shall cover best practices developed by some market surveillance authorities which may be of benefit for other market surveillance authorities, and other relevant aspects related to the effectiveness of market surveillance activities. 4. The outcome of the peer reviews shall be reported to the Network. Article 13 National market surveillance strategies 1. Each Member State shall draw up an overarching national market surveillance strategy, at least every four years. Each Member State shall draw up the first such strategy by 16 July 2022. The national strategy shall promote a consistent, comprehensive and integrated approach to market surveillance and to the enforcement of Union harmonisation legislation within the territory of the Member State. When drawing up the national market surveillance strategy, all sectors covered by the Union harmonisation legislation and all stages of the product supply chain, including imports and digital supply chains, shall be considered. The priorities set out within the work programme of the Network may also be considered. 2. The national market surveillance strategy shall include at least the following elements, when this does not compromise market surveillance activities: (a) the available information on the occurrence of non-compliant products, in particular taking into account the checks and controls referred to in Articles 11(3) and 25(3), respectively, and, where applicable, market trends that may affect non-compliance rates for the categories of products, and possible threats and risks related to emerging technologies; (b) the areas identified by the Member States as priorities for the enforcement of Union harmonisation legislation; (c) the enforcement activities planned in order to reduce non-compliance in those areas identified as priorities, including, where relevant, the minimum control levels envisaged for categories of products which have significant levels of non-compliance; (d) an assessment of the cooperation with market surveillance authorities in other Member States, as referred to in Article 11(8) and Chapter VI. 3. Member States shall communicate their national market surveillance strategy to the Commission and other Member States through the information and communication system referred to in Article 34. Each Member State shall publish a summary of its strategy. CHAPTER V MARKET SURVEILLANCE POWERS AND MEASURES Article 14 Powers of market surveillance authorities 1. Member States shall confer on their market surveillance authorities the powers of market surveillance, investigation and enforcement necessary for the application of this Regulation and for the application of Union harmonisation legislation. 2. Market surveillance authorities shall exercise the powers set out in this Article efficiently and effectively, in accordance with the principle of proportionality, to the extent that such exercise relates to the subject matter and the purpose of the measures and the nature and the overall actual or potential harm resulting from the instance of non-compliance. Powers shall be conferred and exercised in accordance with Union and national law, including the principles of the Charter of Fundamental Rights of the European Union, as well as with principles of national law relating to freedom of expression and the freedom and pluralism of the media, with applicable procedural safeguards and with the Union rules on data protection, in particular Regulation (EU) 2016/679. 3. When conferring powers under paragraph 1, Member States may provide for the power to be exercisable in one of the following ways, as appropriate: (a) directly by the market surveillance authorities under their own authority; (b) by recourse to other public authorities in accordance with the division of powers and the institutional and administrative organisation of the Member State in question; (c) upon application to courts competent to grant the necessary decision to approve the exercise of that power, including, where appropriate, on appeal, if the application to grant the necessary decision was not successful. 4. The powers conferred on market surveillance authorities under paragraph 1 shall include at least the following: (a) the power to require economic operators to provide relevant documents, technical specifications, data or information on compliance and technical aspects of the product, including access to embedded software in so far as such access is necessary for the purpose of assessing the product's compliance with applicable Union harmonisation legislation, in any form or format and irrespective of the medium of storage or the place where such documents, technical specifications, data or information are stored, and to take or obtain copies thereof; (b) the power to require economic operators to provide relevant information on the supply chain, on the details of the distribution network, on quantities of products on the market and on other product models that have the same technical characteristics as the product in question, where relevant for compliance with the applicable requirements under Union harmonisation legislation; (c) the power to require economic operators to provide relevant information required for the purpose of ascertaining the ownership of websites, where the information in question is related to the subject matter of the investigation; (d) the power to carry out unannounced on-site inspections and physical checks of products; (e) the power to enter any premises, land or means of transport that the economic operator in question uses for purposes related to the economic operator's trade, business, craft or profession, in order to identify non-compliance and to obtain evidence; (f) the power to start investigations on market surveillance authorities' own initiative in order to identify non-compliances and bring them to an end; (g) the power to require economic operators to take appropriate action to bring an instance of non-compliance to an end or to eliminate the risk; (h) the power to take appropriate measures where an economic operator fails to take appropriate corrective action or where the non-compliance or the risk persists, including the power to prohibit or restrict the making available of a product on the market or to order that the product is withdrawn or recalled; (i) the power to impose penalties in accordance with Article 41; (j) the power to acquire product samples, including under a cover identity, to inspect those samples and to reverse-engineer them in order to identify non-compliance and to obtain evidence; (k) the power, where no other effective means are available to eliminate a serious risk: (i) to require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end users when they access an online interface; or (ii) where a request according to point (i) has not been complied with, to require information society service providers to restrict access to the online interface, including by requesting a relevant third party to implement such measures. 5. Market surveillance authorities may use any information, document, finding, statement, or any intelligence as evidence for the purpose of their investigations, irrespective of the format in which and medium on which they are stored. Article 15 Recovery of costs by market surveillance authorities 1. Member States may authorise their market surveillance authorities to reclaim from the relevant economic operator the totality of the costs of their activities with respect to instances of non-compliance. 2. The costs referred to in paragraph 1 of this Article may include the costs of carrying out testing, the costs of taking measures in accordance with Article 28(1) and (2), the costs of storage and the costs of activities relating to products that are found to be non-compliant and are subject to corrective action prior to their release for free circulation or their placing on the market. Article 16 Market surveillance measures 1. Market surveillance authorities shall take appropriate measures if a product subject to Union harmonisation legislation, when used in accordance with its intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained: (a) is liable to compromise the health or safety of users; or (b) does not conform to applicable Union harmonisation legislation. 2. Where market surveillance authorities make findings referred to in point (a) or (b) of paragraph 1, they shall without delay require the relevant economic operator to take appropriate and proportionate corrective action to bring the non-compliance to an end or to eliminate the risk within a period they specify. 3. For the purposes of paragraph 2, the corrective action required to be taken by the economic operator may include, inter alia: (a) bringing the product into compliance, including by rectifying formal non-compliance as defined by the applicable Union harmonisation legislation, or by ensuring that the product no longer presents a risk; (b) preventing the product from being made available on the market; (c) withdrawing or recalling the product immediately and alerting the public to the risk presented; (d) destroying the product or otherwise rendering it inoperable; (e) affixing to the product suitable, clearly worded, easily comprehensible warnings of the risks that it might present, in the language or languages determined by the Member State in which the product is made available on the market; (f) setting prior conditions for making the product concerned available on the market; (g) alerting the end users at risk immediately and in an appropriate form, including by publication of special warnings in the language or languages determined by the Member State in which the product is made available on the market. 4. Corrective actions referred to in points (e), (f) and (g) of paragraph 3 may only be required in cases where the product is liable to present a risk only in certain conditions or only to certain end users. 5. If the economic operator fails to take corrective action referred to in paragraph 3 or where the non-compliance or the risk referred to in paragraph 1 persists, market surveillance authorities shall ensure that the product is withdrawn or recalled, or that its being made available on the market is prohibited or restricted, and that the public, the Commission and the other Member States are informed accordingly. 6. The information to the Commission and the other Member States pursuant to paragraph 5 of this Article shall be communicated through the information and communication system referred to in Article 34. That communication of information shall also be deemed to fulfil notification requirements for the applicable safeguard procedures of Union harmonisation legislation. 7. Where a national measure is considered to be justified in accordance with the applicable safeguard procedure, or where no market surveillance authority of another Member State concluded the contrary as referred to in Article 11(9), the competent market surveillance authorities in the other Member States shall take the necessary measures in respect of the non-compliant product and shall enter the relevant information in the information and communication system referred to in Article 34. Article 17 Use of information, professional and commercial secrecy Market surveillance authorities shall perform their activities with a high level of transparency and shall make available to the public any information that they consider to be relevant in order to protect the interests of end users. Market surveillance authorities shall respect the principles of confidentiality and of professional and commercial secrecy and shall protect personal data in accordance with Union and national law. Article 18 Procedural rights of economic operators 1. Any measure, decision or order taken or made by market surveillance authorities pursuant to Union harmonisation legislation or this Regulation shall state the exact grounds on which it is based. 2. Any such measure, decision or order shall be communicated without delay to the relevant economic operator, who shall at the same time be informed of the remedies available to it under the law of the Member State concerned and of the time limits to which those remedies are subject. 3. Before a measure, decision or order referred to in paragraph 1 is taken or made, the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 working days, unless it is not possible to give the economic operator that opportunity because of the urgency of the measure, decision or order, based on health or safety requirements or other grounds relating to the public interests covered by the relevant Union harmonisation legislation. If the measure, decision or order is taken or made without the economic operator being given the opportunity to be heard, the economic operator shall be given that opportunity as soon as possible thereafter and that measure, decision or order shall be reviewed promptly by the market surveillance authority. Article 19 Products presenting a serious risk 1. Market surveillance authorities shall ensure that products presenting a serious risk are withdrawn or recalled, where there is no other effective means available to eliminate the serious risk, or that their being made available on the market is prohibited. Market surveillance authorities shall notify the Commission thereof immediately, in accordance with Article 20. 2. A decision whether or not a product presents a serious risk shall be based on an appropriate risk assessment that takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety and the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk. Article 20 Rapid Information Exchange System 1. Where a market surveillance authority takes or intends to take a measure pursuant to Article 19 and considers that the reasons which prompted the measure or the effects of the measure go beyond the territory of its Member State, it shall immediately notify the Commission of that measure in accordance with paragraph 4 of this Article. The market surveillance authority shall also inform the Commission without delay of the modification or withdrawal of any such measure. 2. If a product presenting a serious risk has been made available on the market, market surveillance authorities shall immediately notify the Commission of any voluntary measures taken and communicated to the market surveillance authority by an economic operator. 3. The information provided in accordance with paragraphs 1 and 2 shall include all available details, in particular the data necessary for the identification of the product, the origin and the supply chain of the product, the risk related to the product, the nature and the duration of the national measure taken and any voluntary measures taken by economic operators. 4. For the purposes of paragraphs 1, 2 and 3 of this Article, the Rapid Information Exchange System (RAPEX) provided for in Article 12 of Directive 2001/95/EC shall be used. Paragraphs 2, 3 and 4 of Article 12 of that Directive shall apply mutatis mutandis. 5. The Commission shall provide and maintain a data interface between RAPEX and the information and communication system referred to in Article 34 so as to avoid double data entry. Article 21 Union testing facilities 1. The objective of the Union testing facilities is to contribute to enhancing laboratory capacity, as well as to ensuring the reliability and consistency of testing, for the purposes of market surveillance within the Union. 2. For the purposes of paragraph 1, the Commission may designate a public testing facility of a Member State as a Union testing facility for specific categories of products or for specific risks related to a category of products. The Commission may also designate one of its own testing facilities as a Union testing facility for specific categories of products or for specific risks related to a category of products, or for products for which testing capacity is missing or is not sufficient. 3. Union testing facilities shall be accredited in accordance with Regulation (EC) No 765/2008. 4. The designation of Union testing facilities shall not affect the freedom of market surveillance authorities, the Network and the Commission to choose testing facilities for the purpose of their activities. 5. Designated Union testing facilities shall provide their services solely to market surveillance authorities, the Network, the Commission and other government or intergovernmental entities. 6. Union testing facilities shall, within the area of their competence, perform the following activities: (a) carry out testing of products at the request of market surveillance authorities, the Network or the Commission; (b) provide independent technical or scientific advice at the request of the Network; (c) develop new techniques and methods of analysis. 7. The activities referred to in paragraph 6 of this Article shall be remunerated and may be financed by the Union in accordance with Article 36(2). 8. Union testing facilities may receive financing by the Union in accordance with Article 36(2) in order to increase their testing capacity or to create new testing capacity for specific categories of products or for specific risks related to a category of products for which the testing capacity is missing or is insufficient. 9. The Commission shall adopt implementing acts specifying the procedures for the designation of Union testing facilities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). CHAPTER VI CROSS-BORDER MUTUAL ASSISTANCE Article 22 Mutual Assistance 1. There shall be efficient cooperation and exchange of information among the market surveillance authorities of the Member States, and between market surveillance authorities and the Commission and the relevant Union agencies. 2. When a market surveillance authority is unable to conclude its investigation because of its inability to access certain information, despite having made all appropriate efforts to obtain that information, it may submit a reasoned request to the market surveillance authority of another Member State where access to this information can be enforced. In this case the requested authority shall supply to the applicant authority without delay, and in any event within 30 days, any information that the requested authority considers to be relevant in order to establish whether a product is non-compliant. 3. The requested authority shall undertake appropriate investigations or take any other measures that are appropriate in order to gather the requested information. Where necessary, those investigations shall be carried out with the assistance of other market surveillance authorities. 4. The applicant authority shall remain responsible for any investigation that it has initiated, unless the requested authority agrees to take over responsibility. 5. In duly justified cases, a requested authority may refuse to comply with a request for information under paragraph 2 where: (a) the applicant authority has not sufficiently substantiated that the requested information is necessary in order to establish non-compliance; (b) the requested authority demonstrates reasonable grounds showing that complying with the request would substantially impair the execution of its own activities. Article 23 Requests for enforcement measures 1. Where bringing non-compliance with regard to a product to an end requires measures within the jurisdiction of another Member State and where such measures do not result from the requirements of Article 16(7), an applicant authority may submit a duly reasoned request for enforcement measures to a requested authority in that other Member State. 2. The requested authority shall without delay take all appropriate and necessary enforcement measures using the powers conferred on it under this Regulation in order to bring the instance of non-compliance to an end by exercising the powers laid down in Article 14 and any additional powers granted to it under national law. 3. The requested authority shall inform the applicant authority about the measures referred to in paragraph 2 that have been taken or which are intended to be taken. A requested authority may refuse to comply with a request for enforcement measures in any of the following situations: (a) the requested authority concludes that the applicant authority has not provided sufficient information; (b) the requested authority considers that the request is contrary to Union harmonisation legislation; (c) the requested authority demonstrates reasonable grounds showing that complying with the request would substantially impair the execution of its own activities. Article 24 Procedure for mutual assistance requests 1. Before submitting a request under Article 22 or 23, the applicant authority shall endeavour to carry out all reasonable possible investigations. 2. When submitting a request under Article 22 or 23, the applicant authority shall provide all available information in order to enable the requested authority to fulfil the request, including any necessary evidence obtainable only in the Member State of the applicant authority. 3. Requests under Articles 22 and 23 and all communication related to them shall be made using electronic standard forms by means of the information and communication system referred to in Article 34. 4. Communication shall take place directly between the involved market surveillance authorities or through the single liaison offices of the Member States concerned. 5. The languages to be used for requests under Articles 22 and 23 and for all communication linked to them shall be agreed upon by the market surveillance authorities concerned. 6. Where no agreement about the languages to be used can be reached between the market surveillance authorities concerned, the requests under Articles 22 and 23 shall be sent in the official language of the Member State of the applicant authority, and the replies to such requests shall be sent in the official language of the Member State of the requested authority. In such case, the applicant authority and the requested authority shall arrange for the translation of the requests, replies or other documents that it receives from the other authority. 7. The information and communication system referred to in Article 34 shall provide structured information on mutual assistance cases to the single liaison offices involved. Using this information, single liaison offices shall provide any support that is necessary to facilitate assistance. CHAPTER VII PRODUCTS ENTERING THE UNION MARKET Article 25 Controls on products entering the Union market 1. Member States shall designate customs authorities, one or more market surveillance authorities or any other authority in their territory as the authorities in charge of the control on products entering the Union market. Each Member State shall inform the Commission and the other Member States of the authorities designated under the first subparagraph and of their areas of competence through the information and communication system referred to in Article 34. 2. The authorities designated under paragraph 1 shall have the necessary powers and resources for the proper performance of their tasks as referred to in that paragraph. 3. Products subject to Union law that are to be placed under the customs procedure ‘release for free circulation’ shall be subject to controls performed by the authorities designated under paragraph 1 of this Article. They shall perform those controls on the basis of risk analysis in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013 and, where relevant, on the basis of risk-based approach as referred to in the second subparagraph of Article 11(3) of this Regulation. 4. Risk-related information shall be exchanged between: (a) the authorities designated under paragraph 1 of this Article in accordance with Article 47(2) of Regulation (EU) No 952/2013; and (b) customs authorities in accordance with Article 46(5) of Regulation (EU) No 952/2013. Where, in relation to products subject to Union law that are either in temporary storage or placed under a customs procedure other than ‘release for free circulation’, customs authorities at the first point of entry have reason to believe that those products are not compliant with applicable Union law or present a risk, they shall transmit all relevant information to the competent customs office of destination. 5. Market surveillance authorities shall provide authorities designated under paragraph 1 with information on categories of products or the identity of economic operators where a higher risk of non-compliance has been identified. 6. By 31 March of each year, Member States shall submit to the Commission detailed statistical data covering controls performed by the authorities designated under paragraph 1 with respect to products subject to Union law during the previous calendar year. The statistical data shall cover the number of interventions in the field of controls on such products with regard to product safety and compliance. The Commission shall draw up a report by 30 June of each year, containing the information provided by the Member States for the previous calendar year and an analysis of the data submitted. The report shall be published in the information and communication system referred to in Article 34. 7. Where the Commission becomes aware of a serious risk presented by products subject to Union law that are imported from a third country, it shall recommend to the Member State concerned to take appropriate market surveillance measures. 8. The Commission, after consulting the Network, may adopt implementing acts laying down benchmarks and techniques for checks on the basis of common risk analysis on the Union level, in order to ensure a consistent enforcement of Union law, to strengthen the controls on products entering the Union market and to ensure an effective and uniform level of such controls. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). 9. The Commission shall adopt implementing acts further specifying the details of the data to be submitted under paragraph 6 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). Article 26 Suspension of release for free circulation 1. Authorities designated under Article 25(1) shall suspend the release of a product for free circulation if in the course of controls pursuant to Article 25(3), it is established that: (a) the product is not accompanied by the documentation required by the Union law applicable to it or there is a reasonable doubt as to the authenticity, accuracy or completeness of such documentation; (b) the product is not marked or labelled in accordance with the Union law applicable to it; (c) the product bears a CE marking or other marking required by the Union law applicable to it which has been affixed in a false or misleading manner; (d) the name, registered trade name or registered trade mark and the contact details, including the postal address, of an economic operator with tasks regarding the product subject to certain Union harmonisation legislation is not indicated or identifiable in accordance with Article 4(4); or (e) for any other reason, when there is cause to believe that the product does not comply with the Union law applicable to it or that it presents a serious risk to health, safety, the environment or any other public interest referred to in Article 1. 2. Authorities designated under Article 25(1) shall immediately notify the market surveillance authorities of any suspension of release referred to in paragraph 1 of this Article. 3. Where the market surveillance authorities have reasonable grounds to believe that a product does not comply with the Union law applicable to it or presents a serious risk, they shall request the authorities designated under Article 25(1) to suspend the process for its release for free circulation. 4. Notifications under paragraph 2 and requests under paragraph 3 of this Article may take place by means of the information and communication system referred to in Article 34, including through the use of electronic interfaces between this system and systems used by customs authorities, when they are available. Article 27 Release for free circulation Where the release of a product for free circulation has been suspended in accordance with Article 26, that product shall be released for free circulation where all the other requirements and formalities relating to such a release have been fulfilled and where either of the following conditions is satisfied: (a) within four working days of the suspension, the authorities designated under Article 25(1) have not been requested by the market surveillance authorities to maintain the suspension; (b) the authorities designated under Article 25(1) have been informed by the market surveillance authorities of its approval for release for free circulation. The release for free circulation shall not be deemed to be proof of conformity with Union law. Article 28 Refusal to release for free circulation 1. Where the market surveillance authorities conclude that a product presents a serious risk, they shall take measures to prohibit the placing of the product on the market and shall require the authorities designated under Article 25(1) not to release it for free circulation. They shall also require these authorities to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the product and on any other relevant accompanying document: ‘Dangerous product — release for free circulation not authorised — Regulation (EU) 2019/1020’. Market surveillance authorities shall immediately enter that information in the information and communication system referred to in Article 34. 2. Where market surveillance authorities conclude that a product may not be placed on the market since it does not comply with the Union law applicable to it, they shall take measures to prohibit the placing of the product on the market and shall require the authorities designated under Article 25(1) not to release it for free circulation. They shall also require those authorities to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the product and on any other relevant accompanying document: ‘Product not in conformity — release for free circulation not authorised — Regulation (EU) 2019/1020’. Market surveillance authorities shall immediately enter that information in the information and communication system referred to in Article 34. 3. Where the product referred to in paragraph 1 or 2 is subsequently declared for a customs procedure other than release for free circulation and provided that the market surveillance authorities do not object, the notice required by paragraph 1 or 2 shall also be included, under the same conditions as required by paragraph 1 or 2, in the documents used in connection with that procedure. 4. Authorities designated under Article 25(1) may destroy or otherwise render inoperable a product which presents a risk to the health and safety of end users where the authority in question considers that it is necessary and proportionate to do so. The cost of such measure shall be borne by the natural or legal person declaring the product for free circulation. Articles 197 and 198 of Regulation (EU) No 952/2013 shall apply accordingly. CHAPTER VIII COORDINATED ENFORCEMENT AND INTERNATIONAL COOPERATION Article 29 Union Product Compliance Network 1. A Union Product Compliance Network (‘the Network’) is hereby established. 2. The purpose of the Network is to serve as a platform for structured coordination and cooperation between enforcement authorities of the Member States and the Commission, and to streamline the practices of market surveillance within the Union, thereby making market surveillance more effective. Article 30 Composition and functioning of the Network 1. The Network shall be composed of representatives from each Member State, including a representative of each single liaison office referred to in Article 10 and an optional national expert, the chairs of ADCOs, and representatives from the Commission. 2. Separate or joint ADCOs shall be established for the uniform application of Union harmonisation legislation. ADCOs shall be composed of representatives of the national market surveillance authorities and, if appropriate, representatives of the single liaison offices. ADCOs meetings are intended only for representatives of market surveillance authorities and the Commission. Relevant stakeholders, such as organisations representing the interests of industry, small and medium-sized enterprises (SMEs), consumers, testing laboratories, standardisation and conformity assessment bodies at Union level, may be invited to attend the ADCOs meetings depending on the subject matter of discussion. 3. The Commission shall support and encourage cooperation between market surveillance authorities through the Network and participate in the meetings of the Network, its sub-groups and the ADCOs. 4. The Network shall meet at regular intervals and, where necessary, at the reasoned request of the Commission or a Member State. 5. The Network may establish standing or temporary sub-groups dealing with specific questions and tasks. 6. The Network may invite experts and other third parties, including the organisations representing the interests of industry, SMEs, consumers, testing laboratories, standardisation and conformity assessment bodies at Union level, to attend meetings as observers or to provide written contributions. 7. The Network shall use its best endeavours to reach consensus. Decisions taken by the Network shall be legally non-binding recommendations. 8. The Network shall establish its own rules of procedure. Article 31 Role and tasks of the Network 1. In carrying out the tasks set out in paragraph 2, the Network shall address general, horizontal issues of market surveillance with a view to facilitating the cooperation among single liaison offices, as well as the Commission. 2. The Network shall have the following tasks: (a) to prepare, adopt and monitor the implementation of its work programme; (b) to facilitate the identification of common priorities for market surveillance activities and the exchange of information across sectors on evaluations of products, including risk assessment, test methods and results, recent scientific developments and new technologies, emerging risks and other aspects relevant to control activities and on the implementation of national market surveillance strategies and activities; (c) to coordinate ADCOs and their activities; (d) to organise cross-sector joint market surveillance and testing projects and define their priorities; (e) to exchange expertise and best practices, in particular regarding the implementation of national market surveillance strategies; (f) to facilitate the organisation of training programmes and exchanges of personnel; (g) in collaboration with the Commission, to organise information campaigns and voluntary mutual visit programmes between market surveillance authorities; (h) to discuss questions arising from cross-border mutual assistance mechanisms; (i) to contribute to the development of guidance to ensure the effective and uniform application of this Regulation; (j) to propose the financing of activities referred to in Article 36; (k) to contribute to uniform administrative practices with regard to market surveillance in the Member States; (l) to provide advice and assist the Commission with issues related to the further development of RAPEX and the information and communication system referred to in Article 34; (m) to promote the cooperation and exchange of expertise and best practices between market surveillance authorities and authorities in charge of controls at the Union's external borders; (n) to promote and facilitate collaboration with other relevant networks and groups, with a view to explore possibilities for using new technologies for the purposes of market surveillance and traceability of products; (o) to evaluate regularly the national market surveillance strategies, the first such evaluation taking place by 16 July 2024; (p) to take up any other issues in activities within the remit of the Network, with the aim of contributing to the effective functioning of market surveillance within the Union. Article 32 Role and tasks of administrative cooperation groups 1. In carrying out the tasks set out in paragraph 2, ADCOs shall address specific matters related to market surveillance and sector specific issues. 2. ADCOs shall have the following tasks: (a) to facilitate the uniform application of Union harmonisation legislation within their area of competence with a view to increasing the efficiency of market surveillance throughout the internal market; (b) to promote communication between market surveillance authorities and the Network and develop mutual confidence between market surveillance authorities; (c) to establish and coordinate common projects, such as cross-border joint market surveillance activities; (d) to develop common practices and methodologies for effective market surveillance; (e) to inform each other of national market surveillance methods and activities and to develop and promote best practices; (f) to identify issues of shared interest relating to market surveillance and suggest common approaches to be adopted; (g) to facilitate sector-specific evaluations of products, including risk assessments, test methods and results, recent scientific developments and other aspects relevant to control activities. Article 33 Role and tasks of the Commission The Commission shall have the following tasks: (a) to assist the Network, its sub-groups, and the ADCOs by means of an executive secretariat that provides technical and logistic support; (b) to keep and make available to the single liaison offices and ADCO chairs an updated list of ADCO chairs, including their contact information; (c) to assist the Network in preparing and monitoring its work programme; (d) to support the functioning of the Product Contact Points having duties assigned by Member States in relation to Union harmonisation legislation; (e) to determine, in consultation with the Network, the need for additional testing capacity and to propose solutions for that purpose, in accordance with Article 21; (f) to apply the instruments of international cooperation referred to in Article 35; (g) to provide support for the establishment of separate or joint ADCOs; (h) to develop and maintain the information and communication system referred to in Article 34, including the interface referred to in Article 34(7), as well as the interface with national market surveillance databases, and provide information to the public by means of that system; (i) to assist the Network to perform preliminary or ancillary work in connection with the implementation of market surveillance activities linked to the application of Union harmonisation legislation, such as studies, programmes, evaluations, comparative analyses, mutual joint visits and visit programmes, exchange of personnel, research work, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work; (j) to prepare and assist in the implementation of Union market surveillance campaigns and similar activities; (k) to organise joint market surveillance and testing projects, and common training programmes, to facilitate exchanges of personnel between market surveillance authorities and, where appropriate, with the market surveillance authorities of third countries or with international organisations, and to organise information campaigns and voluntary mutual visit programmes between market surveillance authorities; (l) to carry out activities under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of Union market surveillance policies and systems among interested parties at Union and international level; (m) to facilitate technical or scientific expertise for the purpose of implementing market surveillance administrative cooperation; (n) to examine, at the request of the Network or on its own initiative, any question covering the application of this Regulation and issue guidelines, recommendations and best practices in order to encourage consistent application of this Regulation. Article 34 Information and communication system 1. The Commission shall further develop and maintain an information and communication system for the collection, processing and storage of information, in a structured form, on issues relating to the enforcement of Union harmonisation legislation, with the aim of improving the sharing of data among Member States, including for the purpose of requests for information, providing a comprehensive overview of market surveillance activities, results and trends. The Commission, market surveillance authorities, single liaison offices, and authorities designated under Article 25(1) shall have access to that system. The Commission shall develop and maintain the public user interface of this system, where key information for end-users about market surveillance activities shall be provided. 2. The Commission shall further develop and maintain electronic interfaces between the system referred to in paragraph 1 and national market surveillance systems. 3. Single liaison offices shall enter the following information in the information and communication system: (a) the identity of the market surveillance authorities in their Member State and areas of competence of those authorities pursuant to Article 10(2); (b) the identity of the authorities designated under Article 25(1); (c) the national market surveillance strategy drawn up by their Member State under Article 13 and the results from the review and assessment of the market surveillance strategy. 4. Market surveillance authorities shall enter into the information and communication system in relation to products made available on the market for which an in-depth check of compliance has been carried out, without prejudice to Article 12 of Directive 2001/95/EC and Article 20 of this Regulation, and where applicable, in relation to products entering the Union market for which the process for the release for free circulation has been suspended in accordance with Article 26 of this Regulation, in their territory, the following information concerning: (a) measures according to Article 16(5) taken by that market surveillance authority; (b) reports of testing carried out by them; (c) corrective action taken by economic operators concerned; (d) readily available reports on injuries caused by the product in question; (e) any objection raised by a Member State in accordance with the applicable safeguard procedure in the Union harmonisation legislation applicable to the product and any subsequent follow-up; (f) where available, failures by authorised representatives to comply with Article 5(2); (g) where available, failures by manufacturers to comply with Article 5(1). 5. Where market surveillance authorities consider it useful, they may enter into the information and communication system any additional information related to the checks they perform and results of testing carried out by them or at their request. 6. Where relevant for the enforcement of Union harmonisation legislation and for the purpose of minimising risk, customs authorities shall extract from national customs systems information on products placed under the customs procedure ‘release for free circulation’ related to the enforcement of Union harmonisation legislation and transmit it to the information and communication system. 7. The Commission shall develop an electronic interface to enable the transmission of data between national customs systems and the information and communication system. This interface shall be in place within four years from the date of adoption of the relevant implementing act referred to in paragraph 8. 8. The Commission shall adopt implementing acts specifying the details of implementation arrangements for paragraphs 1 to 7 of this Article, and in particular the data processing to be applied on data collected in accordance with paragraph 1 of this Article, and defining the data to be transmitted in accordance with paragraphs 6 and 7 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). Article 35 International cooperation 1. In order to improve the efficiency of market surveillance in the Union, the Commission may cooperate with and exchange market surveillance related information with regulatory authorities of third countries or international organisations within the framework of agreements concluded between the Union and third countries or international organisations. Any such agreements shall be based on reciprocity, include provisions on confidentiality corresponding to those applicable in the Union, and ensure that any exchange of information is in accordance with applicable Union law. 2. The cooperation or exchange of information may relate, inter alia, to the following: (a) risk assessment methods used and the results of product-testing; (b) coordinated product recalls or other similar actions; (c) the measures taken by market surveillance authorities under Article 16. 3. The Commission may approve a specific system of product-related pre-export control carried out by a third country on products immediately prior to their export into the Union in order to verify that those products satisfy the requirements of the Union harmonisation legislation applicable to them. The approval may be granted in respect of one or more products, in respect of one or more categories of products or in respect of products or categories of products manufactured by certain manufacturers. 4. The Commission shall produce and maintain a list of those products or categories of products with regard to which approval has been granted as referred to in paragraph 3 and shall make this list available to the public. 5. Approval may only be granted to a third country under paragraph 3 if following conditions are satisfied: (a) the third country possesses an efficient verification system of the compliance of products exported to the Union, and the controls carried out in that third country are sufficiently effective and efficient to replace or reduce import controls; (b) audits within the Union and, if relevant, in the third country demonstrate that products exported from that third country to the Union satisfy the requirements set out in Union harmonisation legislation. 6. Where such an approval has been granted, the risk assessment applied to import controls for those products or categories of products entering the Union market, referred to in paragraph 3, shall include the granted approvals. Authorities designated under Article 25(1) may however carry out controls on those products or categories of products entering the Union market, including in order to ensure that the pre-export controls carried out by the third country are effective to determine compliance with Union harmonisation legislation. 7. The approval referred to in paragraph 3 shall specify the competent authority of the third country under whose responsibility the pre-export controls are to be performed and that competent authority shall be the counterpart for all contacts with the Union. 8. The competent authority, referred to in paragraph 7, shall ensure the official verification of the products prior to their entry into the Union. 9. Where controls on products entering the Union market referred to in paragraph 3 of this Article reveal significant non-compliance, the market surveillance authorities shall notify immediately the Commission through the information and communication system referred to in Article 34 and adapt the level of controls on such products. 10. The Commission shall adopt implementing acts approving each specific system of product-related pre-export controls, referred to in paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). 11. The Commission shall regularly monitor the correct functioning of the approval granted under paragraph 3 of this Article. The Commission shall adopt implementing acts withdrawing that approval where it is revealed that the products entering the Union market do not comply with Union harmonisation legislation in a significant number of instances. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 43(2). The Commission shall immediately inform the third country concerned thereof. 12. The system of product-related pre-export control shall be evaluated in accordance with Article 42(4). CHAPTER IX FINANCIAL PROVISIONS Article 36 Financing activities 1. The Union shall finance performance of the tasks of the Network referred to in Article 31 and the peer reviews referred to in Article 12. 2. The Union may finance the following activities in relation to the application of this Regulation: (a) the functioning of the Product Contact Points; (b) the establishment and functioning of Union testing facilities referred to in Article 21; (c) the development of instruments of international cooperation referred to in Article 35; (d) the drawing up and updating of contributions to guidelines on market surveillance; (e) the making available to the Commission of technical or scientific expertise for the purpose of assisting the Commission in its implementation of market surveillance administrative cooperation; (f) the implementation of national market surveillance strategies referred to in Article 13; (g) Member States' and Union market surveillance campaigns and associated activities, including resources and equipment, IT tools and training; (h) the performance of preliminary or ancillary work in connection with market surveillance activities related to the application of Union harmonisation legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits and visit programmes, exchange of personnel, research work, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work; (i) activities carried out under programmes providing technical assistance, cooperation with third countries and the promotion and enhancement of Union market surveillance policies and systems amongst interested parties at Union and international level. 3. The Union shall finance the electronic interface referred to in Article 34(7), including the development of the information and communication system referred to in Article 34 to enable it to receive automatic flows of electronic data from the national customs systems. 4. The Union shall finance the electronic interfaces referred to in Article 34(2) enabling the exchange of data between the information and communication system referred to in Article 34 and the national market surveillance systems. 5. The Union's financial assistance with respect to the activities in support of this Regulation shall be implemented in accordance with Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (52), either directly, or by entrusting budget implementation tasks to the entities listed in point (c) of Article 62(1) of that Regulation. 6. The appropriations allocated to activities referred to in this Regulation shall be determined each year by the budgetary authority within the limits of the financial framework in force. 7. The appropriations determined by the budgetary authority for the financing of market surveillance activities may also cover expenses relating to preparatory work, monitoring, control, audit and evaluation activities which are required for the management of the activities set out in this Regulation and for the achievement of their objectives. These expenses shall include the costs of conducting studies, arranging meetings of experts, information and communication activities, including corporate communication of the political priorities of the Union in so far as they are related to the general objectives of market surveillance activities, expenses linked to information technology networks focusing on information processing and exchange together with all other related technical and administrative assistance expenses incurred by the Commission. Article 37 Protection of the financial interests of the Union 1. The Commission shall take appropriate measures to ensure that, when activities financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective controls and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties. 2. The Commission or its representatives and the Court of Auditors shall have the power of audit, on the basis of documents and of on-the-spot inspections, over all grant beneficiaries, contractors and subcontractors who have received Union funds under this Regulation. 3. The European Anti-Fraud Office (OLAF) may carry out investigations, including on-the-spot controls and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (53) and Council Regulation (Euratom, EC) No 2185/96 (54) with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant agreement or grant decision or a contract funded under this Regulation. 4. Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countries and with international organisations, contracts, grant agreements and grant decisions resulting from the implementation of this Regulation shall contain provisions expressly empowering the Commission, the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their respective competences. CHAPTER X AMENDMENTS Article 38 Amendments to Directive 2004/42/EC Articles 6 and 7 of Directive 2004/42/EC of the European Parliament and of the Council (55) are deleted. Article 39 Amendments to Regulation (EC) No 765/2008 1. Regulation (EC) No 765/2008 is amended as follows: (1) the title is replaced by the following: ‘Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93’; (2) in Article 1, paragraphs 2 and 3 are deleted; (3) in Article 2, points 1, 2, 14, 15, 17, 18 and 19 are deleted; (4) Chapter III, containing Articles 15 to 29, is deleted; (5) paragraph 1 of Article 32 is amended as follows: (a) point (c) is replaced by the following: ‘(c) the drawing up and updating of contributions to guidelines in the fields of accreditation, notification to the Commission of conformity assessment bodies and conformity assessment;’; (b) points (d) and (e) are deleted; (c) points (f) and (g) are replaced by the following: ‘(f) the performance of preliminary or ancillary work in connection with the implementation of the conformity assessment, metrology and accreditation activities linked to the implementation of Community legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work; (g) activities carried out under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of European conformity assessment and accreditation policies and systems among interested parties in the Community and at international level.’ 2. References to the deleted provisions of Regulation (EC) No 765/2008 shall be construed as references to the provisions of this Regulation and shall be read in accordance with the correlation table in Annex III to this Regulation. Article 40 Amendments to Regulation (EU) No 305/2011 In Article 56(1) of Regulation (EU) No 305/2011, the first subparagraph is replaced by the following: ‘1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a construction product covered by a harmonised standard or for which a European Technical Assessment has been issued does not achieve the declared performance and presents a risk for the fulfilment of the basic requirements for construction works covered by this Regulation, they shall carry out an evaluation in relation to the product concerned covering the respective requirements laid down by this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities.’ CHAPTER XI FINAL PROVISIONS Article 41 Penalties 1. The Member States shall lay down the rules on penalties applicable to infringements of this Regulation and of Union harmonisation legislation listed in Annex II that impose obligations on economic operators and shall take all measures necessary to ensure that they are implemented in accordance with national law. 2. The penalties provided for shall be effective, proportionate and dissuasive. 3. The Member States shall, by 16 October 2021, notify those provisions to the Commission, where they have not previously been notified, and shall notify it, without delay, of any subsequent amendment affecting them. Article 42 Evaluation, review and guidelines 1. By 31 December 2026 and every five years thereafter, the Commission shall carry out an evaluation of this Regulation in light of the objectives that it pursues and shall present a report thereon to the European Parliament, to the Council and to the European Economic and Social Committee. 2. The report shall assess whether this Regulation achieved its objective, in particular with regard to reducing the number of non-compliant products on the Union market, ensuring effective and efficient enforcement of Union harmonisation legislation within the Union, improving cooperation between competent authorities and strengthening the controls on products entering the Union market, while taking into account the impact on business and in particular on SMEs. In addition, the evaluation shall also assess the scope of this Regulation, the effectiveness of the peer review system and of the market surveillance activities that receive Union financing in the light of the requirements of Union policies and law and the possibilities to further improve the cooperation between the market surveillance authorities and customs authorities. 3. By 16 July 2023, the Commission shall prepare an evaluation report on the implementation of Article 4. The report shall in particular evaluate the scope of that Article, its effects and its costs and benefits. The report shall be accompanied, where appropriate, by a legislative proposal. 4. Within four years after the first approval of a specific system of product-related pre-export control referred to in Article 35(3), the Commission shall carry out an evaluation of its effects and cost efficiency. 5. In order to facilitate the implementation of this Regulation, the Commission shall draw up guidelines for the practical implementation of Article 4 for the purposes of market surveillance authorities and economic operators. Article 43 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act in respect of the implementing powers referred to in Article 11(4), Article 21(9), Article 25(8), Article 35(10) and Article 35(11) of this Regulation, and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. Article 44 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 16 July 2021. However, Articles 29, 30, 31, 32, 33 and 36 shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 June 2019. For the European Parliament The President A. TAJANI For the Council The President G. CIAMBA (1) OJ C 283, 10.8.2018, p. 19. (2) Position of the European Parliament of 17 April 2019 (not yet published in the Official Journal) and decision of the Council of 14 June 2019. (3) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59). (4) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). (5) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). (6) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1). (7) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4). (8) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (9) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). (10) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). (11) Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251). (12) Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46). (13) Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1). (14) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1). (15) Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15). (16) Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1). (17) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1). (18) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52). (19) Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (OJ L 96, 29.3.2014, p. 1). (20) Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146). (21) Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53). (22) Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1). (23) Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1). (24) Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1). (25) Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.3.2019, p. 1). (26) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (27) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (28) Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1). (29) OJ L 123, 12.5.2016, p. 1. (30) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (31) Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service (OJ L 15, 21.1.1998, p. 14). (32) Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 April 2018 on cross-border parcel delivery services (OJ L 112, 2.5.2018, p. 19). (33) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (34) Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5). (35) Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51). (36) Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99). (37) Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1). (38) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24). (39) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1). (40) Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10). (41) Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88). (42) Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (OJ L 178, 28.6.2013, p. 27). (43) Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90). (44) Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45). (45) Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79). (46) Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107). (47) Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149). (48) Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309). (49) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357). (50) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). (51) Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164). (52) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (53) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (54) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (55) Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, p. 87). ANNEX I List of Union harmonisation legislation 1. Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36); 2. Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (OJ L 42, 23.2.1970, p. 16); 3. Council Directive 75/107/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as measuring containers (OJ L 42, 15.2.1975, p. 14); 4. Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (OJ L 147, 9.6.1975, p. 40); 5. Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain pre-packaged products (OJ L 46, 21.2.1976, p. 1); 6. Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40); 7. Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992, p. 17); 8. Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to labelling of the materials used in the main components of footwear for sale to the consumer (OJ L 100, 19.4.1994, p. 37); 9. European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10); 10. Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L 350, 28.12.1998, p. 58); 11. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1); 12. Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1); 13. Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles (OJ L 269, 21.10.2000, p. 34); 14. Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (OJ L 304, 21.11.2003, p. 1); 15. Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1); 16. Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7); 17. Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, p. 87); 18. Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC (OJ L 310, 25.11.2005, p. 10); 19. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24); 20. Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, p. 12); 21. Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC (OJ L 266, 26.9.2006, p. 1); 22. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1); 23. Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 171, 29.6.2007, p. 1); 24. Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC (OJ L 247, 21.9.2007, p. 17); 25. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1); 26. Regulation (EC) No 78/2009 of the European Parliament and of the Council of 14 January 2009 on the type-approval of motor vehicles with regard to the protection of pedestrians and other vulnerable road users, amending Directive 2007/46/EC and repealing Directives 2003/102/EC and 2005/66/EC (OJ L 35, 4.2.2009, p. 1); 27. Regulation (EC) No 79/2009 of the European Parliament and of the Council of 14 January 2009 on type-approval of hydrogen-powered motor vehicles, and amending Directive 2007/46/EC (OJ L 35, 4.2.2009, p. 32); 28. Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control (OJ L 106, 28.4.2009, p. 7); 29. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1); 30. Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009 on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC (OJ L 188, 18.7.2009, p. 1); 31. Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, p. 1); 32. Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10); 33. Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p. 1); 34. Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46); 35. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59); 36. Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (OJ L 27, 30.1.2010, p. 1); 37. Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1); 38. Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5); 39. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88); 40. Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile fibre names and related labelling and marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council (OJ L 272, 18.10.2011, p. 1); 41. Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1); 42. Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38); 43. Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1); 44. Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52); 45. Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (OJ L 178, 28.6.2013, p. 27); 46. Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90); 47. Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (OJ L 96, 29.3.2014, p. 1); 48. Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45); 49. Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014, p. 79); 50. Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107); 51. Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149); 52. Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251); 53. Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309); 54. Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357); 55. Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1); 56. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62); 57. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164); 58. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146); 59. Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006 (OJ L 150, 20.5.2014, p. 195); 60. Regulation (EU) No 540/2014 of the European Parliament and of the Council of 16 April 2014 on the sound level of motor vehicles and of replacement silencing systems, and amending Directive 2007/46/EC and repealing Directive 70/157/EEC (OJ L 158, 27.5.2014, p. 131); 61. Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1); 62. Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51); 63. Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99); 64. Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53); 65. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1); 66. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176); 67. Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008 (OJ L 137, 24.5.2017, p. 1); 68. Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1); 69. Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1); 70. Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1), in so far as the design, production and placing on the market of aircrafts referred to in points (a) and (b) of Article 2(1) thereof, where it concerns unmanned aircraft and their engines, propellers, parts and equipment to control them remotely, are concerned. ANNEX II List of Union harmonisation legislation without provisions on penalties 1. Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36); 2. Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (OJ L 42, 23.2.1970, p. 16); 3. Council Directive 75/107/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as measuring containers (OJ L 42, 15.2.1975, p. 14); 4. Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (OJ L 147, 9.6.1975, p. 40); 5. Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain pre-packaged products (OJ L 46, 21.2.1976, p. 1); 6. Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992, p. 17); 7. Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to labelling of the materials used in the main components of footwear for sale to the consumer (OJ L 100, 19.4.1994, p. 37); 8. European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10); 9. Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1); 10. Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles (OJ L 269, 21.10.2000, p. 34); 11. Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC (OJ L 310, 25.11.2005, p. 10); 12. Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, p. 12); 13. Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC (OJ L 247, 21.9.2007, p. 17); 14. Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46); 15. Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1); 16. Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5); 17. Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 on textile fibre names and related labelling and marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council (OJ L 272, 18.10.2011, p. 1); 18. Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146); 19. Regulation (EU) No 540/2014 of the European Parliament and of the Council of 16 April 2014 on the sound level of motor vehicles and of replacement silencing systems, and amending Directive 2007/46/EC and repealing Directive 70/157/EEC (OJ L 158, 27.5.2014, p. 131). ANNEX III Correlation table Regulation (EC) No 765/2008 This Regulation Article 1(2) Article 1(1) Article 1(3) Article 1(3) Article 2, point 1 Article 3, point 1 Article 2, point 2 Article 3, point 2 Article 2, point 14 Article 3, point 22 Article 2, point 15 Article 3, point 23 Article 2, point 17 Article 3, point 3 Article 2, point 18 Article 3, point 4 Article 2, point 19 Article 3, point 25 Article 15(1) and (2) Article 2(1) Article 15(3) Article 2(3) Article 15(4) — Article 15(5) Article 2(2) Article 16(1) Article 10(1) Article 16(2) Article 16(5) Article 16(3) — Article 16(4) — Article 17(1) Article 10(2) Article 17(2) Article 34(1), last sentence and Article 34(3), point (a) Article 18(1) Article 10(6) Article 18(2), point (a) Article 11(7), point (a) Article 18(2), point (b) — Article 18(2), point (c) Article 11(7), point (b) Article 18(2), point (d) — Article 18(3) Articles 10(5) and 14(1) Article 18(4) Article 14(2) Article 18(5) Article 13 Article 18(6) Article 31(2), point (o) Article 19(1), first subparagraph Article 11(3) Article 19(1), second subparagraph Article 14(4), points (a), (b), (e) and (j) Article 19(1), third subparagraph Article 11(5) Article 19(2) Article 16(3), point (g) Article 19(3) Article 18(2) Article 19(4) Article 11(2) Article 19(5) Article 17 Article 20(1) Article 19(1) Article 20(2) Article 19(2) Article 21(1) Article 18(1) Article 21(2) Article 18(2) Article 21(3) Article 18(3) Article 21(4) — Article 22(1) Article 20(1) Article 22(2) Article 20(2) Article 22(3) Article 20(3) Article 22(4) Article 20(4) Article 23(1) and (3) Article 34(1) Article 23(2) Article 34(4) Article 24(1) Article 22(1) Article 24(2) Article 22(2) to (5) Article 24(3) — Article 24(4) — Article 25(1) — Article 25(2), point (a) Article 31(2), point (f) and Article 33(1), points (i) and (k) Article 25(2), point (b) Article 31(2), points (g) and (m) and Article 33(1), points (i) and (k) Article 25(3) — Article 26 — Article 27(1), first sentence Article 25(2) Article 27(1), second sentence Article 25(3) Article 27(2) Article 25(4) Article 27(3), first subparagraph Article 26(1) Article 27(3), second subparagraph Article 26(2) Article 27(4) — Article 27(5) — Article 28(1) Article 27, first paragraph, point (a) Article 28(2) Article 27, first paragraph, point (b) Article 29(1) Article 28(1) Article 29(2) Article 28(2) Article 29(3) Article 28(3) Article 29(4) Article 28(4) Article 29(5) Article 25(5) Article 32(1), point (d) — Article 32(1), point (e) Article 36(2), point (e)

Market surveillance and compliance of products Market surveillance and compliance of products SUMMARY OF: Regulation (EU) 2019/1020 — market surveillance and compliance of products WHAT IS THE AIM OF THE REGULATION? It aims to improve how the free movement of goods principle works by strengthening market surveillance* of products covered by EU hamonisation legislation. This must ensure a high level of protection of health and safety, in general and in the workplace, and protect consumers, the environment, public security and other public interest. It lays down rules and procedures for economic operators* and establishes a system for their cooperation with supervisory authorities. It establishes controls on products imported into the EU. It deletes and replaces Articles 15 to 29 of Regulation (EC) No 765/2008 (see summary on Accreditation and market surveillance) and amends Directive 2004/42/EC and Regulation (EU) No 305/2011 (see summary on Construction products). KEY POINTS The regulation applies to products: covered by EU harmonisation legislation (and set out in Annex I); imported into the EU which are not subject to specific legislation. Certain products may not be offered for sale to EU consumers without an economic operator established in the EU: who keeps EU conformity and performance declarations and makes these and the technical documentation available to authorities when asked; who informs the authorities when they consider a product poses a risk; who cooperates with the authorities, when asked, by taking immediate corrective action — from remedying the fault to recall or destroying the item — if a product is considered non-compliant, and helps to eliminate or mitigate risks; whose name and contact details are on the product, packaging or accompanying document. Market surveillance authorities: carry out effective surveillance of products sold online and offline; perform appropriate documentary, physical and laboratory checks on products, taking into account possible hazards; act when a product, properly installed, maintained and used for its intended purpose: could damage users’ health and safety,does not conform to EU legislation; ensure economic operators take corrective action when instructed and act when they fail to do so; establish procedures to follow up complaints and reports and to verify economic operators have taken corrective action; apply a high level of transparency and make available to the public any information they consider relevant to protect end users’ interests; provide economic operators with grounds for their decisions to give them an opportunity to respond; notify the European Commission and the other EU countries immediately of any measures they take if these could have an impact in other EU countries; may ask colleagues elsewhere in the EU to help with investigations and enforcement and participate in peer reviews to improve the system’s overall efficiency; have powers to: start investigations on their own initiative,require economic operators to provide relevant documents, data and information on supply chains, distribution networks, product models and ownership of websites,carry out unannounced onsite inspections and physical checks,enter any premises, land or means of transport an economic operator uses,acquire product samples without revealing their identity,instruct economic operators to take measures to end non-compliance or eliminate risk,prohibit or restrict availability of a product and order it be withdrawn or recalled,insist in case of serious risk that product content is removed from a website or require it be accompanied by a warning,adopt measures, including penalties, against economic operators that fail to act. EU countries: designate one or more authorities with the powers of market surveillance, investigation and enforcement; appoint a single liaison office to represent the surveillance authorities and communicate the country’s national strategy; ensure the authorities and office have sufficient budgetary and other resources; may authorise surveillance authorities to reclaim from an economic operator all the costs they incur when pursuing non-compliance cases; draw up an overarching national market surveillance strategy every 4 years from 16 July 2022 to promote a consistent, comprehensive and integrated approach to market surveillance — this must include: data on non-compliant products,priority areas for enforcing the EU legislation,enforcement activities to reduce non-compliance,assessment of cooperation between authorities in other EU countries; provide economic operators, at their request and free of charge, information on national implementation of EU product harmonisation legislation; introduce effective, proportionate and dissuasive penalties and notify these to the Commission by 16 October 2021. The Commission: ensures the Your Europe portal provides users with easy online access to information about the EU’s product requirements, rights, obligations and rules; adopts implementing acts; assists the EU Product Compliance Network (see below) in all its activities; maintains a computer system to store and process all the data collected; reports to the European Parliament, the Council and the European Economic and Social Committee by 31 December 2026, and every 5 years thereafter, on the regulation’s implementation. Specific rules apply to imported products: EU countries designate authorities with the necessary powers to check imports; market surveillance authorities provide them with information on products and economic operators where a high risk of non-compliance has been identified; authorities may impound a product if the necessary documentation is absent or there are concerns it presents a serious health, safety, environmental or public interest risk, and only release it when certain conditions are met. The regulation: establishes an EU Product Compliance Network — it: develops cooperation between the surveillance authorities and the Commission;contains national and Commission representatives and experts;organises a range of activities to improve market surveillance across the EU. FROM WHEN DOES THE REGULATION APPLY? It applies from 16 July 2021. However, Articles 29, 30, 31, 32, 33 (on the EU Product Compliance Network) and 36 (on financing activities) apply from 1 January 2021. BACKGROUND For more information, see: Market surveillance for products (European Commission). KEY TERMS Market surveillance: measures to ensure products comply with EU legislation and protect the public interest. Economic operator: manufacturer, authorised representative, importer, distributor or fulfilment service provider. MAIN DOCUMENT Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, pp. 1-44) RELATED DOCUMENTS Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, pp. 5-43) Successive amendments to Regulation (EU) No 305/2011 have been incorporated into the original text. This consolidated version is of documentary value only. Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, pp. 30-47) Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, pp. 87-96) See consolidated version. last update 30.08.2019

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26.11.2019 EN Official Journal of the European Union L 305/17 DIRECTIVE (EU) 2019/1937 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 October 2019 on the protection of persons who report breaches of Union law THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 16, Article 43(2), Article 50, Article 53(1), Articles 91, 100, and 114, Article 168(4), Article 169, Article 192(1) and Article 325(4) thereof and to the Treaty establishing the European Atomic Energy Community, and in particular Article 31 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the Court of Auditors (1), Having regard to the opinion of the European Economic and Social Committee (2), After consulting the Committee of the Regions, Having regard to the opinion of 30 November 2018 of the Group of Experts referred to in Article 31 of the Treaty establishing the European Atomic Energy Community, Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Persons who work for a public or private organisation or are in contact with such an organisation in the context of their work-related activities are often the first to know about threats or harm to the public interest which arise in that context. By reporting breaches of Union law that are harmful to the public interest, such persons act as ‘whistleblowers’ and thereby play a key role in exposing and preventing such breaches and in safeguarding the welfare of society. However, potential whistleblowers are often discouraged from reporting their concerns or suspicions for fear of retaliation. In this context, the importance of providing balanced and effective whistleblower protection is increasingly acknowledged at both Union and international level. (2) At Union level, reports and public disclosures by whistleblowers are one upstream component of enforcement of Union law and policies. They feed national and Union enforcement systems with information, leading to effective detection, investigation and prosecution of breaches of Union law, thus enhancing transparency and accountability. (3) In certain policy areas, breaches of Union law, regardless of whether they are categorised under national law as administrative, criminal or other types of breaches, may cause serious harm to the public interest, in that they create significant risks for the welfare of society. Where weaknesses of enforcement have been identified in those areas, and whistleblowers are usually in a privileged position to disclose breaches, it is necessary to enhance enforcement by introducing effective, confidential and secure reporting channels and by ensuring that whistleblowers are protected effectively against retaliation. (4) Whistleblower protection currently provided in the Union is fragmented across Member States and uneven across policy areas. The consequences of breaches of Union law with a cross-border dimension reported by whistleblowers illustrate how insufficient protection in one Member State negatively impacts the functioning of Union policies not only in that Member State, but also in other Member States and in the Union as a whole. (5) Common minimum standards ensuring that whistleblowers are protected effectively should apply as regards acts and policy areas where there is a need to strengthen enforcement, under-reporting by whistleblowers is a key factor affecting enforcement, and breaches of Union law can cause serious harm to the public interest. Member States could decide to extend the application of national provisions to other areas with a view to ensuring that there is a comprehensive and coherent whistleblower protection framework at national level. (6) Whistleblower protection is necessary to enhance the enforcement of Union law on public procurement. It is necessary, not only to prevent and detect procurement-related fraud and corruption in the context of the implementation of the Union budget, but also to tackle insufficient enforcement of rules on public procurement by national contracting authorities and contracting entities in relation to the execution of works, the supply of products or the provision of services. Breaches of such rules create distortions of competition, increase costs for doing business, undermine the interests of investors and shareholders and, in general, lower attractiveness for investment and create an uneven playing field for all businesses across the Union, thus affecting the proper functioning of the internal market. (7) In the area of financial services, the added value of whistleblower protection has already been acknowledged by the Union legislator. In the aftermath of the financial crisis, which exposed serious shortcomings in the enforcement of the relevant rules, measures for the protection of whistleblowers, including internal and external reporting channels, as well as an explicit prohibition of retaliation, were introduced in a significant number of legislative acts in the area of financial services as indicated by the Commission in its communication of 8 December 2010 entitled ‘Reinforcing sanctioning regimes in the financial services sector’. In particular, in the context of the prudential framework applicable to credit institutions and investment firms, Directive 2013/36/EU of the European Parliament and of the Council (4) provides for whistleblower protection which applies in the context of Regulation (EU) No 575/2013 of the European Parliament and of the Council (5). (8) As regards the safety of products placed on the internal market, businesses involved in the manufacturing and distribution chain are the primary source of evidence, with the result that reporting by whistleblowers in such businesses has a high added value, since they are much closer to information about possible unfair and illicit manufacturing, import or distribution practices regarding unsafe products. Accordingly, there is a need to introduce whistleblower protection in relation to the safety requirements applicable to products regulated by the Union harmonisation legislation as set out in Annexes I and II to Regulation (EU) 2019/1020 of the European Parliament and of the Council (6), and in relation to the general product safety requirements as set out in Directive 2001/95/EC of the European Parliament and of the Council (7). Whistleblower protection as provided for in this Directive would also be instrumental in avoiding diversion of firearms, their parts and components and ammunition, as well as of defence-related products, since it would encourage the reporting of breaches of Union law, such as document fraud, altered marking and fraudulent acquisition of firearms within the Union where breaches often imply a diversion from the legal to the illegal market. Whistleblower protection as provided for in this Directive would also help prevent the illicit manufacture of homemade explosives by contributing to the correct application of restrictions and controls regarding explosives precursors. (9) The importance of whistleblower protection in terms of preventing and deterring breaches of Union rules on transport safety, which can endanger human lives, has already been acknowledged in sectorial Union acts on aviation safety, namely in Regulation (EU) No 376/2014 of the European Parliament and of the Council (8), and maritime transport safety, namely in Directives 2013/54/EU (9) and 2009/16/EC (10) of the European Parliament and of the Council, which provide for tailored measures of protection for whistleblowers as well as specific reporting channels. Those acts also provide for the protection of workers who report their own honest mistakes against retaliation, so-called ‘just culture’. It is necessary to complement the existing elements of whistleblower protection in those two sectors, as well as to provide protection in other transport modes, namely inland waterway, road and railway transport, to enhance the enforcement of safety standards as regards those transport modes. (10) As regards the area of protection of the environment, evidence-gathering, preventing, detecting and addressing environmental crimes and unlawful conduct remain a challenge and actions in that regard need to be reinforced, as acknowledged by the Commission in its communication of 18 January 2018 entitled ‘EU actions to improve environmental compliance and governance’. Given that before the entry into force of this Directive, the only existing whistleblower protection rules related to environmental protection are provided for in one sectorial act, namely Directive 2013/30/EU of the European Parliament and of the Council (11), the introduction of such protection is necessary to ensure effective enforcement of the Union environmental acquis, the breaches of which can cause harm to the public interest with possible spillover impacts across national borders. The introduction of such protection is also relevant in cases where unsafe products can cause environmental harm. (11) Enhancing whistleblower protection would also contribute to preventing and deterring breaches of European Atomic Energy Community rules on nuclear safety, radiation protection and responsible and safe management of spent fuel and radioactive waste. It would also strengthen the enforcement of the relevant provisions of Council Directive 2009/71/Euratom (12), concerning promotion and enhancement of an effective nuclear safety culture and, in particular, point (a) of Article 8b(2) of that Directive, which requires, inter alia, that the competent regulatory authority establishes management systems which give due priority to nuclear safety and promote, at all levels of staff and management, the ability to question the effective delivery of relevant safety principles and practices and to report in a timely manner on safety issues. (12) The introduction of a whistleblower protection framework would also contribute to strengthening the enforcement of existing provisions, and to preventing breaches of Union rules, in the area of the food chain and, in particular, on food and feed safety, as well as on animal health, protection and welfare. The different Union rules laid down in those areas are closely interlinked. Regulation (EC) No 178/2002 of the European Parliament and of the Council (13) sets out the general principles and requirements which underpin all Union and national measures relating to food and feed, with a particular focus on food safety, in order to ensure a high level of protection of human health and consumers' interests in relation to food, as well as the effective functioning of the internal market. That Regulation provides, inter alia, that food and feed business operators are prevented from discouraging their employees and others from cooperating with competent authorities where such cooperation could prevent, reduce or eliminate a risk arising from food. The Union legislator has taken a similar approach in the area of animal health through Regulation (EU) 2016/429 of the European Parliament and of the Council (14) establishing the rules for the prevention and control of animal diseases which are transmissible to animals or to humans and in the area of the protection and well-being of animals kept for farming purposes, of animals used for scientific purposes, of animals during transport and of animals at the time of killing, through Council Directive 98/58/EC (15) and Directive 2010/63/EU of the European Parliament and of the Council (16), as well as Council Regulations (EC) No 1/2005 (17) and (EC) No 1099/2009 (18), respectively. (13) The reporting of breaches by whistleblowers can be key to detecting and preventing, reducing or eliminating risks to public health and to consumer protection resulting from breaches of Union rules, which might otherwise remain hidden. In particular, consumer protection is also strongly linked to cases where unsafe products can cause considerable harm to consumers. (14) Respect for privacy and protection of personal data, which are enshrined as fundamental rights in Articles 7 and 8 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), are other areas in which whistleblowers can help to disclose breaches, which can harm the public interest. Whistleblowers can also help disclose breaches of Directive (EU) 2016/1148 of the European Parliament and of the Council (19) on the security of network and information systems, which introduces a requirement to provide notification of incidents, including those that do not compromise personal data, and security requirements for entities providing essential services across many sectors, for example energy, health, transport and banking, for providers of key digital services, for example cloud computing services, and for suppliers of basic utilities, such as water, electricity and gas. Whistleblowers' reporting in this area is particularly valuable for the prevention of security incidents that would affect key economic and social activities and widely used digital services, as well as for the prevention of any infringement of Union data protection rules. Such reporting helps ensure the continuity of services that are essential for the functioning of the internal market and the wellbeing of society. (15) Furthermore, the protection of the financial interests of the Union, which is related to the fight against fraud, corruption and any other illegal activity affecting Union expenditure, the collection of Union revenues and funds or Union assets, is a core area in which enforcement of Union law needs to be strengthened. The strengthening of the protection of the financial interests of the Union is relevant also for the implementation of the Union budget as regards expenditure that is incurred on the basis of the Treaty establishing the European Atomic Energy Community (Euratom Treaty). Lack of effective enforcement in the area of protection of the financial interests of the Union, including as regards prevention of fraud and corruption at national level, leads to a decrease of Union revenues and a misuse of Union funds, which can distort public investments, hinder growth and undermine citizens' trust in Union action. Article 325 of the Treaty on the Functioning of the European Union (TFEU) requires the Union and the Member States to counter fraud and any other illegal activities affecting the financial interests of the Union. Relevant Union measures in this respect include, in particular, Council Regulation (EC, Euratom) No 2988/95 (20) and Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (21). Regulation (EC, Euratom) No 2988/95 is complemented, for the most serious types of fraud-related conduct, by Directive (EU) 2017/1371 of the European Parliament and of the Council (22) and by the Convention drawn up on the basis of Article K.3 of the Treaty on European Union, on the protection of the European Communities' financial interests of 26 July 1995 (23), including the Protocols thereto of 27 September 1996 (24), of 29 November 1996 (25) and of 19 June 1997 (26). That Convention and those Protocols remain in force for the Member States not bound by Directive (EU) 2017/1371. (16) Common minimum standards for the protection of whistleblowers should also be laid down for breaches relating to the internal market as referred to in Article 26(2) TFEU. In addition, in accordance with the case law of the Court of Justice of the European Union (the ‘Court’), Union measures aimed at establishing or ensuring the functioning of the internal market are intended to contribute to the elimination of existing or emerging obstacles to the free movement of goods or to the freedom to provide services, and to contribute to the removal of distortions of competition. (17) Specifically, the protection of whistleblowers to enhance the enforcement of Union competition law, including concerning State aid, would serve to safeguard the efficient functioning of markets in the Union, allow a level playing field for business and deliver benefits to consumers. As regards competition rules applying to undertakings, the importance of insider reporting in detecting competition law infringements has already been recognised in the leniency policy pursued by the Commission under Article 4a of Commission Regulation (EC) No 773/2004 (27) as well as with the recent introduction of an anonymous whistleblower tool by the Commission. Breaches relating to competition law and State aid rules concern Articles 101, 102, 106, 107 and 108 TFEU and rules of secondary law adopted for their application. (18) Breaches of corporate tax law and arrangements of which the purpose is to obtain a tax advantage and to evade legal obligations, thereby defeating the object or purpose of the applicable corporate tax law, negatively affect the proper functioning of the internal market. Such breaches and arrangements can give rise to unfair tax competition and extensive tax evasion, distorting the level playing field for businesses and resulting in a loss of tax revenues for Member States and for the Union budget as a whole. This Directive should provide for protection against retaliation for persons who report evasive and/or abusive arrangements that could otherwise go undetected, with a view to strengthening the ability of competent authorities to safeguard the proper functioning of the internal market and remove distortions and barriers to trade that affect the competitiveness of businesses in the internal market, and that are directly linked to the free movement rules and are also relevant for the application of the State aid rules. Whistleblower protection as provided for in this Directive would add to recent Commission initiatives aimed at improving transparency and the exchange of information in the field of taxation, and creating a fairer corporate tax environment within the Union with a view to increasing Member States' effectiveness in identifying evasive and/or abusive arrangements, and would help deter such arrangements. However, this Directive does not harmonise provisions relating to taxes, whether substantive or procedural, and does not seek to strengthen the enforcement of national corporate tax rules, without prejudice to the possibility of Member States to use reported information for that purpose. (19) Point (a) of Article 2(1) defines the material scope of this Directive by means of a reference to a list of Union acts set out in the Annex. This implies that where those Union acts, in turn, define their material scope by reference to Union acts listed in their annexes, the latter acts also form part of the material scope of this Directive. In addition, the reference to the acts in the Annex should be understood as including all national and Union implementing or delegated measures adopted pursuant to those acts. Moreover, the reference to the Union acts in the Annex is to be understood as a dynamic reference, in accordance with the standard referencing system for legal acts of the Union. Thus, if a Union act in the Annex has been or is amended, the reference relates to the act as amended; if a Union act in the Annex has been or is replaced, the reference relates to the new act. (20) Certain Union acts, in particular in the area of financial services, such as Regulation (EU) No 596/2014 of the European Parliament and of the Council (28), and Commission Implementing Directive (EU) 2015/2392 (29), adopted on the basis of that Regulation, already contain detailed rules on whistleblower protection. Any specific rules in that regard provided for in such existing Union legislation, including the Union acts listed in Part II of the Annex to this Directive, which are tailored to the relevant sectors, should be maintained. This is of particular importance for ascertaining which legal entities in the area of financial services, the prevention of money laundering and terrorist financing are currently obliged to establish internal reporting channels. At the same time, in order to ensure consistency and legal certainty across Member States, this Directive should be applicable in respect of all matters not regulated under the sector-specific acts, and thereby should complement such acts, so that they are fully aligned with minimum standards. In particular, this Directive should provide further detail as to the design of the internal and external reporting channels, the obligations of competent authorities, and the specific forms of protection to be provided at national level against retaliation. In that regard, Article 28(4) of Regulation (EU) No 1286/2014 of the European Parliament and of the Council (30) provides for Member States to be able to provide for an internal reporting channel in the area covered by that Regulation. For reasons of consistency with the minimum standards laid down by this Directive, the obligation to establish internal reporting channels provided for in this Directive should also apply in respect of Regulation (EU) No 1286/2014. (21) This Directive should be without prejudice to the protection granted to workers when reporting breaches of Union employment law. In particular, in the area of occupational safety and health, Article 11 of Council Directive 89/391/EEC (31) already requires Member States to ensure that workers or workers' representatives are not placed at a disadvantage because of requests or proposals they make to employers to take appropriate measures to mitigate hazards for workers and/or to remove sources of danger. Workers and their representatives are entitled, under that Directive, to raise issues with the competent authority if they consider that the measures taken, and the means employed, by the employer are inadequate for the purposes of ensuring safety and health. (22) Member States could decide to provide that reports concerning interpersonal grievances exclusively affecting the reporting person, namely grievances about interpersonal conflicts between the reporting person and another worker, can be channelled to other procedures. (23) This Directive should be without prejudice to the protection granted by the procedures for reporting possible illegal activities, including fraud or corruption, that are detrimental to the interests of the Union, or for reporting conduct relating to the discharge of professional duties, which could constitute a serious failure to comply with the obligations of officials and other servants of the European Union established under Articles 22a, 22b and 22c of the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants of the Union, laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (32). This Directive should apply where officials and other servants of the Union report breaches that occur in a work-related context outside their employment relationship with the Union institutions, bodies, offices or agencies. (24) National security remains the sole responsibility of each Member State. This Directive should not apply to reports of breaches related to procurement involving defence or security aspects where those are covered by Article 346 TFEU, in accordance with the case law of the Court. If Member States decide to extend the protection provided under this Directive to further areas or acts, which are not within its material scope, it should be possible for them to adopt specific provisions to protect essential interests of national security in that regard. (25) This Directive should also be without prejudice to the protection of classified information which Union law or the laws, regulations or administrative provisions in force in the Member State concerned require, for security reasons, to be protected from unauthorised access. Moreover, this Directive should not affect the obligations arising from Council Decision 2013/488/EU (33) or Commission Decision (EU, Euratom) 2015/444 (34). (26) This Directive should not affect the protection of confidentiality of communications between lawyers and their clients (‘legal professional privilege’) as provided for under national and, where applicable, Union law, in accordance with the case law of the Court. Moreover, this Directive should not affect the obligation of maintaining the confidential nature of communications of health care providers, including therapists, with their patients and of patient records (‘medical privacy’) as provided for under national and Union law. (27) Members of professions other than lawyers and health care providers should be able to qualify for protection under this Directive when they report information protected by the applicable professional rules, provided that reporting that information is necessary for the purposes of revealing a breach falling within the scope of this Directive. (28) While this Directive should provide, under certain conditions, for a limited exemption from liability, including criminal liability, in the event of a breach of confidentiality, it should not affect national rules on criminal procedure, particularly those aiming at safeguarding the integrity of the investigations and proceedings or the rights of defence of persons concerned. This should be without prejudice to the introduction of measures of protection into other types of national procedural law, in particular, the reversal of the burden of proof in national administrative, civil or labour proceedings. (29) This Directive should not affect national rules on the exercise of the rights of employees' representatives to information, consultation, and participation in collective bargaining and their defence of workers' employment rights. This should be without prejudice to the level of protection granted under this Directive. (30) This Directive should not apply to cases in which persons who, having given their informed consent, have been identified as informants or registered as such in databases managed by authorities appointed at national level, such as customs authorities, and report breaches to enforcement authorities, in return for reward or compensation. Such reports are made pursuant to specific procedures that aim to guarantee the anonymity of such persons in order to protect their physical integrity, and that are distinct from the reporting channels provided for under this Directive. (31) Persons who report information about threats or harm to the public interest obtained in the context of their work-related activities make use of their right to freedom of expression. The right to freedom of expression and information, enshrined in Article 11 of the Charter and in Article 10 of the Convention for the Protection of Human Rights and Fundamental Freedoms, encompasses the right to receive and impart information as well as the freedom and pluralism of the media. Accordingly, this Directive draws upon the case law of the European Court of Human Rights (ECHR) on the right to freedom of expression, and the principles developed on this basis by the Council of Europe in its Recommendation on the Protection of Whistleblowers adopted by its Committee of Ministers on 30 April 2014. (32) To enjoy protection under this Directive, reporting persons should have reasonable grounds to believe, in light of the circumstances and the information available to them at the time of reporting, that the matters reported by them are true. That requirement is an essential safeguard against malicious and frivolous or abusive reports as it ensures that those who, at the time of the reporting, deliberately and knowingly reported wrong or misleading information do not enjoy protection. At the same time, the requirement ensures that protection is not lost where the reporting person reported inaccurate information on breaches by honest mistake. Similarly, reporting persons should be entitled to protection under this Directive if they have reasonable grounds to believe that the information reported falls within its scope. The motives of the reporting persons in reporting should be irrelevant in deciding whether they should receive protection. (33) Reporting persons normally feel more at ease reporting internally, unless they have reasons to report externally. Empirical studies show that the majority of whistleblowers tend to report internally, within the organisation in which they work. Internal reporting is also the best way to get information to the persons who can contribute to the early and effective resolution of risks to the public interest. At the same time, the reporting person should be able to choose the most appropriate reporting channel depending on the individual circumstances of the case. Moreover, it is necessary to protect public disclosures, taking into account democratic principles such as transparency and accountability, and fundamental rights such as freedom of expression and the freedom and pluralism of the media, whilst balancing the interest of employers to manage their organisations and to protect their interests, on the one hand, with the interest of the public to be protected from harm, on the other, in line with the criteria developed in the case law of the ECHR. (34) Without prejudice to existing obligations to provide for anonymous reporting by virtue of Union law, it should be possible for Member States to decide whether legal entities in the private and public sector and competent authorities are required to accept and follow up on anonymous reports of breaches which fall within the scope of this Directive. However, persons who anonymously reported or who made anonymous public disclosures falling within the scope of this Directive and meet its conditions should enjoy protection under this Directive if they are subsequently identified and suffer retaliation. (35) This Directive should provide for protection to be granted in cases where persons report, pursuant to Union legislation, to institutions, bodies, offices or agencies of the Union, for example in the context of fraud concerning the Union budget. (36) Persons need specific legal protection where they acquire the information they report through their work-related activities and therefore run the risk of work-related retaliation, for instance, for breaching the duty of confidentiality or loyalty. The underlying reason for providing such persons with protection is their position of economic vulnerability vis-à-vis the person on whom de facto they depend for work. Where there is no such work-related power imbalance, for instance in the case of ordinary complainants or citizen bystanders, there is no need for protection against retaliation. (37) Effective enforcement of Union law requires that protection should be granted to the broadest possible range of categories of persons, who, irrespective of whether they are Union citizens or third-country nationals, by virtue of their work-related activities, irrespective of the nature of those activities and of whether they are paid or not, have privileged access to information on breaches that it would be in the public interest to report and who may suffer retaliation if they report them. Member States should ensure that the need for protection is determined by reference to all the relevant circumstances and not merely by reference to the nature of the relationship, so as to cover the whole range of persons connected in a broad sense to the organisation where the breach has occurred. (38) Protection should, firstly, apply to persons having the status of ‘workers’, within the meaning of Article 45(1) TFEU, as interpreted by the Court, namely persons who, for a certain period of time, perform services for and under the direction of another person, in return for which they receive remuneration. Protection should, thus, also be granted to workers in non-standard employment relationships, including part-time workers and fixed-term contract workers, as well as persons with a contract of employment or employment relationship with a temporary agency, precarious types of relationships where standard forms of protection against unfair treatment are often difficult to apply. The concept of ‘worker’ also includes civil servants, public service employees, as well as any other persons working in the public sector. (39) Protection should also extend to categories of natural persons, who, whilst not being ‘workers’ within the meaning of Article 45(1) TFEU, can play a key role in exposing breaches of Union law and may find themselves in a position of economic vulnerability in the context of their work-related activities. For instance, as regards product safety, suppliers are much closer to the source of information about possible unfair and illicit manufacturing, import or distribution practices concerning unsafe products; and as regards the implementation of Union funds, consultants providing their services are in a privileged position to draw attention to breaches they witness. Such categories of persons, which include self-employed persons providing services, freelance workers, contractors, subcontractors and suppliers, are typically subject to retaliation, which can take the form, for instance, of early termination or cancellation of a contract for services, a licence or permit, loss of business, loss of income, coercion, intimidation or harassment, blacklisting or business boycotting or damage to their reputation. Shareholders and persons in managerial bodies can also suffer retaliation, for instance in financial terms or in the form of intimidation or harassment, blacklisting or damage to their reputation. Protection should also be granted to persons whose work-based relationship has ended, and to candidates for employment or persons seeking to provide services to an organisation, who acquire information on breaches during the recruitment process or another pre-contractual negotiation stage, and who could suffer retaliation, for instance in the form of negative employment references, blacklisting or business boycotting. (40) Effective whistleblower protection implies protecting also categories of persons who, whilst not relying on their work-related activities economically, can nevertheless suffer retaliation for reporting breaches. Retaliation against volunteers and paid or unpaid trainees could take the form of no longer making use of their services, or of giving them a negative employment reference or otherwise damaging their reputation or career prospects. (41) Protection should be provided against retaliatory measures taken not only directly vis-à-vis reporting persons themselves, but also those that can be taken indirectly, including vis-à-vis facilitators, colleagues or relatives of the reporting person who are also in a work-related connection with the reporting person's employer or customer or recipient of services. Without prejudice to the protection that trade union representatives or employees' representatives enjoy in their capacity as such representatives under other Union and national rules, they should enjoy the protection provided for under this Directive both where they report in their capacity as workers and where they have provided advice and support to the reporting person. Indirect retaliation also includes actions taken against the legal entity that the reporting person owns, works for or is otherwise connected with in a work-related context, such as denial of provision of services, blacklisting or business boycotting. (42) Effective detection and prevention of serious harm to the public interest requires that the notion of breach also includes abusive practices, as defined by the case law of the Court, namely acts or omissions which do not appear to be unlawful in formal terms but defeat the object or the purpose of the law. (43) Effective prevention of breaches of Union law requires that protection is granted to persons who provide information necessary to reveal breaches which have already taken place, breaches which have not yet materialised, but are very likely to take place, acts or omissions which the reporting person has reasonable grounds to consider as breaches, as well as attempts to conceal breaches. For the same reasons, protection is justified also for persons who do not provide positive evidence but raise reasonable concerns or suspicions. At the same time, protection should not apply to persons who report information which is already fully available in the public domain or unsubstantiated rumours and hearsay. (44) There should be a close link between reporting and the adverse treatment suffered, directly or indirectly, by the reporting person, for that adverse treatment to be considered to be retaliation and consequently for the reporting person to be able to enjoy legal protection in that respect. Effective protection of reporting persons as a means of enhancing the enforcement of Union law requires a broad definition of retaliation, encompassing any act or omission occurring in a work-related context and which causes them detriment. This Directive should not, however, prevent employers from taking employment-related decisions which are not prompted by the reporting or public disclosure. (45) Protection against retaliation as a means of safeguarding freedom of expression and the freedom and pluralism of the media should be provided both to persons who report information about acts or omissions within an organisation (‘internal reporting’) or to an outside authority (‘external reporting’) and to persons who make such information available in the public domain, for instance, directly to the public through online platforms or social media, or to the media, elected officials, civil society organisations, trade unions, or professional and business organisations. (46) Whistleblowers are, in particular, important sources for investigative journalists. Providing effective protection to whistleblowers from retaliation increases legal certainty for potential whistleblowers and thereby encourages whistleblowing also through the media. In this respect, protection of whistleblowers as journalistic sources is crucial for safeguarding the ‘watchdog’ role of investigative journalism in democratic societies. (47) For the effective detection and prevention of breaches of Union law, it is vital that the relevant information reaches swiftly those closest to the source of the problem, most able to investigate and with powers to remedy it, where possible. As a principle, therefore, reporting persons should be encouraged to first use internal reporting channels and report to their employer, if such channels are available to them and can reasonably be expected to work. That is the case, in particular, where reporting persons believe that the breach can be effectively addressed within the relevant organisation, and that there is no risk of retaliation. As a consequence, legal entities in the private and public sector should establish appropriate internal procedures for receiving and following up on reports. Such encouragement also concerns cases where such channels were established without it being required by Union or national law. This principle should help foster a culture of good communication and corporate social responsibility in organisations, whereby reporting persons are considered to significantly contribute to self-correction and excellence within the organisation. (48) For legal entities in the private sector, the obligation to establish internal reporting channels should be commensurate with their size and the level of risk their activities pose to the public interest. All enterprises having 50 or more workers should be subject to the obligation to establish internal reporting channels, irrespective of the nature of their activities, based on their obligation to collect VAT. Following an appropriate risk assessment, Member States could also require other enterprises to establish internal reporting channels in specific cases, for instance due to the significant risks that may result from their activities. (49) This Directive should be without prejudice to Member States being able to encourage legal entities in the private sector with fewer than 50 workers to establish internal channels for reporting and follow-up, including by laying down less prescriptive requirements for those channels than those laid down under this Directive, provided that those requirements guarantee confidentiality and diligent follow-up. (50) The exemption of small and micro enterprises from the obligation to establish internal reporting channels should not apply to private enterprises which are obliged to establish internal reporting channels by virtue of Union acts referred to in Parts I.B and II of the Annex. (51) It should be clear that, in the case of legal entities in the private sector that do not provide for internal reporting channels, reporting persons should be able to report externally to the competent authorities and such persons should enjoy the protection against retaliation provided by this Directive. (52) In order to ensure, in particular, that the public procurement rules in the public sector are respected, the obligation to put in place internal reporting channels should apply to all contracting authorities and contracting entities, at local, regional and national level, whilst being commensurate with their size. (53) Provided the confidentiality of the identity of the reporting person is ensured, it is up to each individual legal entity in the private and public sector to define the kind of reporting channels to establish. More specifically, the reporting channels should enable persons to report in writing and submit reports by post, by physical complaint box(es), or through an online platform, whether it be on an intranet or internet platform, or to report orally, by telephone hotline or other voice messaging system, or both. Upon request by the reporting person, such channels should also enable reporting by means of physical meetings, within a reasonable timeframe. (54) Third parties could also be authorised to receive reports of breaches on behalf of legal entities in the private and public sector, provided they offer appropriate guarantees of respect for independence, confidentiality, data protection and secrecy. Such third parties could be external reporting platform providers, external counsel, auditors, trade union representatives or employees' representatives. (55) Internal reporting procedures should enable legal entities in the private sector to receive and investigate in full confidentiality reports by the workers of the entity and of its subsidiaries or affiliates (‘the group’), but also, to any extent possible, by any of the group's agents and suppliers and by any persons who acquire information through their work-related activities with the entity and the group. (56) The choice of the most appropriate persons or departments within a legal entity in the private sector to be designated as competent to receive and follow up on reports depends on the structure of the entity, but, in any case, their function should be such as to ensure independence and absence of conflict of interest. In smaller entities, this function could be a dual function held by a company officer well placed to report directly to the organisational head, such as a chief compliance or human resources officer, an integrity officer, a legal or privacy officer, a chief financial officer, a chief audit executive or a member of the board. (57) In the context of internal reporting, informing, as far as legally possible and in the most comprehensive way possible, the reporting person about the follow-up to the report is crucial for building trust in the effectiveness of the overall system of whistleblower protection and reduces the likelihood of further unnecessary reports or public disclosures. The reporting person should be informed within a reasonable timeframe about the action envisaged or taken as follow-up to the report and the grounds for the choice of that follow-up. Follow-up could include, for instance, referral to other channels or procedures in the case of reports exclusively affecting individual rights of the reporting person, closure of the procedure based on lack of sufficient evidence or other grounds, launch of an internal enquiry and, possibly, its findings and any measures taken to address the issue raised, referral to a competent authority for further investigation, insofar as such information would not prejudice the internal enquiry or the investigation or affect the rights of the person concerned. In all cases, the reporting person should be informed of the investigation's progress and outcome. It should be possible to ask the reporting person to provide further information, during the course of the investigation, albeit without there being an obligation to provide such information. (58) A reasonable timeframe for informing a reporting person should not exceed three months. Where the appropriate follow-up is still being determined, the reporting person should be informed about this and about any further feedback to expect. (59) Persons who are considering reporting breaches of Union law should be able to make an informed decision on whether, how and when to report. Legal entities in the private and public sector that have internal reporting procedures in place should be required to provide information on those procedures as well as on external reporting procedures to relevant competent authorities. It is essential that such information be clear and easily accessible, including, to any extent possible, also to persons other than workers, who come in contact with the entity through their work-related activities, such as service-providers, distributors, suppliers and business partners. For instance, such information could be posted at a visible location accessible to all such persons and on the website of the entity, and could also be included in courses and training seminars on ethics and integrity. (60) Effective detection and prevention of breaches of Union law require ensuring that potential whistleblowers can easily and in full confidentiality bring the information they possess to the attention of the relevant competent authorities that are able to investigate and to remedy the problem, where possible. (61) It may be the case that internal channels do not exist or that they were used but did not function properly, for instance because the report was not dealt with diligently or within a reasonable timeframe, or no appropriate action was taken to address the breach despite the results of the related internal enquiry confirming the existence of a breach. (62) In other cases, the use of internal channels cannot reasonably be expected to function properly. This is most notably the case where reporting persons have valid reasons to believe that they would suffer retaliation in connection with the reporting, including as a result of a breach of confidentiality, or that competent authorities would be better placed to take effective action to address the breach. Competent authorities would be better placed, for example, where the ultimate responsibility holder within the work-related context is involved in the breach, or there is a risk that the breach or related evidence could be concealed or destroyed; or, more generally, the effectiveness of investigative actions by competent authorities might otherwise be jeopardised, such as in the case of reported cartel arrangements and other breaches of competition rules; or the breach requires urgent action, for instance to safeguard the health and safety of persons or to protect the environment. In all cases, persons reporting externally to the competent authorities and, where relevant, to institutions, bodies, offices or agencies of the Union should be protected. This Directive should also grant protection where Union or national law requires the reporting persons to report to the competent national authorities, for instance as part of their job duties and responsibilities or because the breach is a criminal offence. (63) Lack of confidence in the effectiveness of reporting is one of the main factors discouraging potential whistleblowers. Accordingly, there is a need to impose a clear obligation on competent authorities to establish appropriate external reporting channels, to diligently follow up on the reports received, and, within a reasonable timeframe, give feedback to reporting persons. (64) It should be for the Member States to designate the authorities competent to receive information on breaches falling within the scope of this Directive and give appropriate follow-up to the reports. Such competent authorities could be judicial authorities, regulatory or supervisory bodies competent in the specific areas concerned, or authorities of a more general competence at a central level within a Member State, law enforcement agencies, anticorruption bodies or ombudsmen. (65) As recipients of reports, the authorities designated as competent should have the necessary capacities and powers to ensure appropriate follow-up, including assessing the accuracy of the allegations made in the report and addressing the breaches reported by launching an internal enquiry, investigation, prosecution or action for recovery of funds, or other appropriate remedial action, in accordance with their mandate. Alternatively, those authorities should have the necessary powers to refer the report to another authority that should investigate the breach reported, while ensuring that there is appropriate follow-up by such authority. In particular, where Member States wish to establish external reporting channels at a central level, for instance in the area of State aid, Member States should put in place adequate safeguards in order to ensure that the requirements of independence and autonomy laid down in this Directive are respected. The establishment of such external reporting channels should not affect the powers of the Member States or of the Commission concerning supervision in the field of State aid, nor should this Directive affect the exclusive power of the Commission as regards the declaration of compatibility of State aid measures in particular pursuant to Article 107(3) TFEU. With regard to breaches of Articles 101 and 102 TFEU, Member States should designate as competent authorities those referred to in Article 35 of Council Regulation (EC) No 1/2003 (35) without prejudice to the powers of the Commission in this area. (66) Competent authorities should also give feedback to the reporting persons about the action envisaged or taken as follow-up, for instance, referral to another authority, closure of the procedure based on lack of sufficient evidence or other grounds, or launch of an investigation, and possibly its findings and any measures taken to address the issue raised, as well as about the grounds for the choice of that follow-up. Communications on the final outcome of the investigations should not affect the applicable Union rules, which include possible restrictions on the publication of decisions in the area of financial regulation. This should apply mutatis mutandis in the field of corporate taxation, if similar restrictions are provided for by the applicable national law. (67) Follow-up and feedback should take place within a reasonable timeframe, given the need to promptly address the problem that is the subject of the report, as well as the need to avoid unnecessary public disclosures. Such timeframe should not exceed three months, but could be extended to six months where necessary due to the specific circumstances of the case, in particular the nature and complexity of the subject of the report, which may require a lengthy investigation. (68) Union law in specific areas, such as market abuse, namely Regulation (EU) No 596/2014 and Implementing Directive (EU) 2015/2392, civil aviation, namely Regulation (EU) No 376/2014, or safety of offshore oil and gas operations, namely Directive 2013/30/EU, already provides for the establishment of internal and external reporting channels. The obligations to establish such channels laid down in this Directive should build as far as possible on the existing channels provided by specific Union acts. (69) The Commission, as well as some bodies, offices and agencies of the Union, such as the European Anti-Fraud Office (OLAF), the European Maritime Safety Agency (EMSA), the European Aviation Safety Agency (EASA), the European Security and Markets Authority (ESMA) and the European Medicines Agency (EMA), have in place external reporting channels and procedures for receiving reports of breaches falling within the scope of this Directive, which mainly provide for confidentiality of the identity of the reporting persons. This Directive should not affect such external reporting channels and procedures, where they exist, but should ensure that persons reporting to institutions, bodies, offices or agencies of the Union benefit from common minimum standards of protection throughout the Union. (70) To ensure the effectiveness of the procedures for following up on reports and addressing breaches of the Union rules concerned, Member States should be able to take measures to alleviate burdens for competent authorities resulting from reports of minor breaches of provisions falling within the scope of this Directive, repetitive reports or reports of breaches of ancillary provisions, for instance provisions on documentation or notification obligations. Such measures could consist in allowing competent authorities, after due assessment of the matter, to decide that a reported breach is clearly minor and does not require further follow-up pursuant to this Directive, other than closure of the procedure. It should also be possible for Member States to allow competent authorities to close the procedure regarding repetitive reports which do not contain any meaningful new information adding to a past report in respect of which the relevant procedures were concluded, unless new legal or factual circumstances justify a different form of follow-up. Furthermore, Member States should be able to allow competent authorities to prioritise the treatment of reports of serious breaches or breaches of essential provisions falling within the scope of this Directive in the event of high inflows of reports. (71) Where provided for under Union or national law, the competent authorities should refer cases or relevant information on breaches to institutions, bodies, offices or agencies of the Union, including, for the purposes of this Directive, OLAF and the European Public Prosecutor Office (EPPO), without prejudice to the possibility for the reporting person to refer directly to such bodies, offices or agencies of the Union. (72) In many policy areas falling within the material scope of this Directive, there are cooperation mechanisms through which national competent authorities exchange information and carry out follow-up activities in relation to breaches of Union rules with a cross-border dimension. Examples range from the Administrative Assistance and Cooperation System established by Commission Implementing Decision (EU) 2015/1918 (36), in cases of cross-border breaches of the Union agri-food chain legislation, and the Food Fraud Network under Regulation (EC) No 882/2004 of the European Parliament and of the Council (37), the rapid alert system for dangerous non-food products established by Regulation (EC) No 178/2002 of the European Parliament and of the Council (38), the Consumer Protection Cooperation Network under Regulation (EC) No 2006/2004 of the European Parliament and of the Council (39), to the Environmental Compliance and Governance Forum set up by the Commission Decision of 18 January 2018 (40), the European Competition Network established pursuant to Regulation (EC) No 1/2003, and the administrative cooperation in the field of taxation under Council Directive 2011/16/EU (41). Member States' competent authorities should make full use of such existing cooperation mechanisms where relevant as part of their obligation to follow up on reports regarding breaches falling within the scope of this Directive. In addition, Member States' authorities could also cooperate beyond the existing cooperation mechanisms in cases of breaches with a cross-border dimension in areas where such cooperation mechanisms do not exist. (73) In order to enable effective communication with staff members who are responsible for handling reports, it is necessary that the competent authorities have in place channels that are user-friendly, secure, ensure confidentiality for receiving and handling information provided by the reporting person on breaches, and that enable the durable storage of information to allow for further investigations. This could require that such channels are separated from the general channels through which the competent authorities communicate with the public, such as normal public complaints systems or channels through which the competent authority communicates internally and with third parties in its ordinary course of business. (74) Staff members of the competent authorities who are responsible for handling reports should be professionally trained, including on applicable data protection rules, in order to handle reports and to ensure communication with the reporting person, as well as to follow up on the report in a suitable manner. (75) Persons intending to report should be able to make an informed decision on whether, how and when to report. Competent authorities should therefore provide clear and easily accessible information about the available reporting channels with competent authorities, about the applicable procedures and about the staff members responsible for handling reports within those authorities. All information regarding reports should be transparent, easily understandable and reliable in order to promote and not deter reporting. (76) Member States should ensure that competent authorities have in place adequate protection procedures for the processing of reports and for the protection of the personal data of the persons referred to in the report. Such procedures should ensure that the identity of every reporting person, person concerned, and third persons referred to in the report, for example witnesses or colleagues, is protected at all stages of the procedure. (77) It is necessary that staff members of the competent authority who are responsible for handling reports and staff members of the competent authority who have the right of access to the information provided by a reporting person comply with the duty of professional secrecy and confidentiality when transmitting the data both inside and outside the competent authority, including where a competent authority opens an investigation or an internal enquiry or engages in enforcement activities in connection with the report. (78) The regular review of the procedures of competent authorities and the exchange of good practices between them should guarantee that those procedures are adequate and thus serving their purpose. (79) Persons making a public disclosure should qualify for protection in cases where, despite internal and external reporting, the breach remains unaddressed, for instance in cases where the breach was not appropriately assessed or investigated, or no appropriate remedial action was taken. The appropriateness of the follow-up should be assessed according to objective criteria, linked to the obligation of the competent authorities to assess the accuracy of the allegations and to put an end to any possible breach of Union law. The appropriateness of the follow-up will thus depend on the circumstances of each case and of the nature of the rules that have been breached. In particular, a decision by the authorities that a breach was clearly minor and no further follow-up, other than closure of the procedure, was required could constitute appropriate follow-up pursuant to this Directive. (80) Persons making a public disclosure directly should also qualify for protection in cases where they have reasonable grounds to believe that there is an imminent or manifest danger to the public interest, or a risk of irreversible damage, including harm to a person's physical integrity. (81) Persons making a public disclosure directly should also qualify for protection where they have reasonable grounds to believe that in the case of external reporting there is a risk of retaliation or there is a low prospect of the breach being effectively addressed, due to the particular circumstances of the case, such as those where evidence could be concealed or destroyed or where an authority could be in collusion with the perpetrator of the breach or involved in the breach. (82) Safeguarding the confidentiality of the identity of the reporting person during the reporting process and investigations triggered by the report is an essential ex-ante measure to prevent retaliation. It should only be possible to disclose the identity of the reporting person where that is a necessary and proportionate obligation under Union or national law in the context of investigations by authorities or judicial proceedings, in particular to safeguard the rights of defence of persons concerned. Such an obligation could derive, in particular, from Directive 2012/13/EU of the European Parliament and of the Council (42). The protection of confidentiality should not apply where the reporting person has intentionally revealed his or her identity in the context of a public disclosure. (83) Any processing of personal data carried out pursuant to this Directive, including the exchange or transmission of personal data by the competent authorities, should be undertaken in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (43) and with Directive (EU) 2016/680 of the European Parliament and of the Council (44). Any exchange or transmission of information by Union institutions, bodies, offices or agencies should be undertaken in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (45). Particular regard should be had to the principles relating to processing of personal data set out in Article 5 of Regulation (EU) 2016/679, Article 4 of Directive (EU) 2016/680 and Article 4 of Regulation (EU) 2018/1725, and to the principle of data protection by design and by default laid down in Article 25 of Regulation (EU) 2016/679, Article 20 of Directive (EU) 2016/680 and Articles 27 and 85 of Regulation (EU) 2018/1725. (84) The procedures provided for in this Directive and related to follow-up on reports of breaches of Union law in the areas falling within its scope serve an important objective of general public interest of the Union and of the Member States, within the meaning of point (e) of Article 23(1) of Regulation (EU) 2016/679, as they aim to enhance the enforcement of Union law and policies in specific areas where breaches can cause serious harm to the public interest. The effective protection of the confidentiality of the identity of reporting persons is necessary for the protection of the rights and freedoms of others, in particular those of the reporting persons, provided for under point (i) of Article 23(1) of Regulation (EU) 2016/679. Member States should ensure that this Directive is effective, including, where necessary, by restricting, by legislative measures, the exercise of certain data protection rights of persons concerned in line with points (e) and (i) of Article 23(1) and Article 23(2) of Regulation (EU) 2016/679 to the extent, and as long as, necessary to prevent and address attempts to hinder reporting or to impede, frustrate or slow down follow-up, in particular investigations, or attempts to find out the identity of the reporting persons. (85) The effective protection of the confidentiality of the identity of reporting persons is equally necessary for the protection of the rights and freedoms of others, in particular those of the reporting persons, where reports are handled by authorities as defined in point (7) of Article 3 of Directive (EU) 2016/680. Member States should ensure that this Directive is effective, including, where necessary, by restricting, by legislative measures, the exercise of certain data protection rights of persons concerned in line with points (a) and (e) of Article 13(3), points (a) and (e) of Article 15(1), points (a) and (e) of Article 16(4) and Article 31(5) of Directive (EU) 2016/680 to the extent, and as long as, necessary to prevent and address attempts to hinder reporting or to impede, frustrate or slow down follow-up, in particular investigations, or attempts to find out the identity of the reporting persons. (86) Member States should ensure that there is adequate record-keeping as regards all reports of breaches, that every report is retrievable and that information received through reports can be used as evidence in enforcement actions where appropriate. (87) Reporting persons should be protected against any form of retaliation, whether direct or indirect, taken, encouraged or tolerated by their employer or customer or recipient of services and by persons working for or acting on behalf of the latter, including colleagues and managers in the same organisation or in other organisations with which the reporting person is in contact in the context of his or her work-related activities (88) Where retaliation occurs undeterred and unpunished, it has a chilling effect on potential whistleblowers. A clear legal prohibition of retaliation would have an important dissuasive effect, and would be further strengthened by provisions for personal liability and penalties for the perpetrators of retaliation. (89) Potential whistleblowers who are not sure about how to report or whether they will be protected in the end may be discouraged from reporting. Member States should ensure that relevant and accurate information in that regard is provided in a way that is clear and easily accessible to the general public. Individual, impartial and confidential advice, free of charge, should be available on, for example, whether the information in question is covered by the applicable rules on whistleblower protection, which reporting channel might best be used and which alternative procedures are available in the event that the information is not covered by the applicable rules, so-called ‘signposting’. Access to such advice can help to ensure that reports are made through the appropriate channels, in a responsible manner, and that breaches are detected in a timely manner or even prevented. Such advice and information could be provided by an information centre or a single and independent administrative authority. Member States could choose to extend such advice to legal counselling. Where such advice is given to reporting persons by civil society organisations which are bound by a duty of maintaining the confidential nature of the information received, Member States should ensure that such organisations do not suffer retaliation, for instance in the form of economic prejudice through a restriction on their access to funding or blacklisting that could impede the proper functioning of the organisation. (90) Competent authorities should provide reporting persons with the support necessary for them to access protection effectively. In particular, they should provide proof or other documentation required to confirm to other authorities or courts that external reporting has taken place. Under certain national frameworks and in certain cases, reporting persons may benefit from forms of certification of the fact that they meet the conditions of the applicable rules. Notwithstanding such possibilities, they should have effective access to judicial review, whereby it is for the courts to decide, based on all the individual circumstances of the case, whether they meet the conditions of the applicable rules. (91) It should not be possible to rely on individuals' legal or contractual obligations, such as loyalty clauses in contracts or confidentiality or non-disclosure agreements, so as to preclude reporting, to deny protection or to penalise reporting persons for having reported information on breaches or made a public disclosure where providing the information falling within the scope of such clauses and agreements is necessary for revealing the breach. Where those conditions are met, reporting persons should not incur any kind of liability, be it civil, criminal, administrative or employment-related. It is appropriate that there be protection from liability for the reporting or public disclosure under this Directive of information in respect of which the reporting person had reasonable grounds to believe that reporting or public disclosure was necessary to reveal a breach pursuant to this Directive. Such protection should not extend to superfluous information that the person revealed without having such reasonable grounds. (92) Where reporting persons lawfully acquire or obtain access to the information on breaches reported or the documents containing that information, they should enjoy immunity from liability. This should apply both in cases where reporting persons reveal the content of documents to which they have lawful access as well as in cases where they make copies of such documents or remove them from the premises of the organisation where they are employed, in breach of contractual or other clauses stipulating that the relevant documents are the property of the organisation. The reporting persons should also enjoy immunity from liability in cases where the acquisition of or access to the relevant information or documents raises an issue of civil, administrative or labour-related liability. Examples would be cases where the reporting persons acquired the information by accessing the emails of a co-worker or files which they normally do not use within the scope of their work, by taking pictures of the premises of the organisation or by accessing locations they do not usually have access to. Where the reporting persons acquired or obtained access to the relevant information or documents by committing a criminal offence, such as physical trespassing or hacking, their criminal liability should remain governed by the applicable national law, without prejudice to the protection granted under Article 21(7) of this Directive. Similarly, any other possible liability of the reporting persons arising from acts or omissions which are unrelated to the reporting or are not necessary for revealing a breach pursuant to this Directive should remain governed by the applicable Union or national law. In those cases, it should be for the national courts to assess the liability of the reporting persons in the light of all relevant factual information and taking into account the individual circumstances of the case, including the necessity and proportionality of the act or omission in relation to the report or public disclosure. (93) Retaliation is likely to be presented as being justified on grounds other than the reporting and it can be very difficult for reporting persons to prove the link between the reporting and the retaliation, whilst the perpetrators of retaliation may have greater power and resources to document the action taken and the reasoning. Therefore, once the reporting person demonstrates prima facie that he or she reported breaches or made a public disclosure in accordance with this Directive and suffered a detriment, the burden of proof should shift to the person who took the detrimental action, who should then be required to demonstrate that the action taken was not linked in any way to the reporting or the public disclosure. (94) Beyond an explicit prohibition of retaliation provided in law, it is crucial that reporting persons who do suffer retaliation have access to legal remedies and compensation. The appropriate remedy in each case should be determined by the kind of retaliation suffered, and the damage caused in such cases should be compensated in full in accordance with national law. The appropriate remedy could take the form of actions for reinstatement, for instance, in the event of dismissal, transfer or demotion, or of withholding of training or promotion, or for restoration of a cancelled permit, licence or contract; compensation for actual and future financial losses, for example for lost past wages, but also for future loss of income, costs linked to a change of occupation; and compensation for other economic damage, such as legal expenses and costs of medical treatment, and for intangible damage such as pain and suffering. (95) While the types of legal action may vary between legal systems, they should ensure that compensation or reparation is real and effective, in a way which is proportionate to the detriment suffered and is dissuasive. Of relevance in this context are the Principles of the European Pillar of Social Rights, in particular Principle 7 according to which ‘Prior to any dismissal, workers have the right to be informed of the reasons and be granted a reasonable period of notice. They have the right to access to effective and impartial dispute resolution and, in case of unjustified dismissal, a right to redress, including adequate compensation.’. The remedies established at national level should not discourage potential future whistleblowers. For instance, providing for compensation as an alternative to reinstatement in the event of dismissal might give rise to a systematic practice, in particular by larger organisations, thus having a dissuasive effect on future whistleblowers. (96) Of particular importance for reporting persons are interim remedies pending the resolution of legal proceedings that can be protracted. Particularly, actions of interim relief, as provided for under national law, should also be available to reporting persons in order to stop threats, attempts or continuing acts of retaliation, such as harassment or to prevent forms of retaliation, such as dismissal, which might be difficult to reverse after the lapse of lengthy periods and which can ruin the individual financially, a perspective which can seriously discourage potential whistleblowers. (97) Action taken against reporting persons outside the work-related context, through proceedings, for instance, related to defamation, breach of copyright, trade secrets, confidentiality and personal data protection, can also pose a serious deterrent to whistleblowing. In such proceedings, reporting persons should be able to rely on having reported breaches or made a public disclosure in accordance with this Directive as a defence, provided that the information reported or publicly disclosed was necessary to reveal the breach. In such cases, the person initiating the proceedings should carry the burden of proving that the reporting person does not meet the conditions laid down by this Directive. (98) Directive (EU) 2016/943 of the European Parliament and of the Council (46) lays down rules to ensure a sufficient and consistent level of civil redress in the event of unlawful acquisition, use or disclosure of a trade secret. However, it also provides that the acquisition, use or disclosure of a trade secret is to be considered lawful to the extent that it is allowed by Union law. Persons who disclose trade secrets acquired in a work-related context should only benefit from the protection granted by this Directive, including in terms of not incurring civil liability, provided that they meet the conditions laid down by this Directive, including that the disclosure was necessary to reveal a breach falling within the material scope of this Directive. Where those conditions are met, disclosures of trade secrets are to be considered allowed by Union law within the meaning of Article 3(2) of Directive (EU) 2016/943. Moreover, both Directives should be considered as being complementary and the civil redress measures, procedures and remedies as well as exemptions provided for in Directive (EU) 2016/943 should remain applicable for all disclosures of trade secrets falling outside the scope of this Directive. Competent authorities that receive information on breaches that includes trade secrets should ensure that they are not used or disclosed for purposes going beyond what is necessary for proper follow-up of the reports. (99) A significant cost for reporting persons contesting retaliation measures taken against them in legal proceedings can be the relevant legal fees. Although they could recover such fees at the end of the proceedings, they might not be able to pay those fees if charged at the outset of proceedings, especially if they are unemployed and blacklisted. Assistance for criminal legal proceedings, particularly where the reporting persons meet the conditions of Directive (EU) 2016/1919 of the European Parliament and of the Council (47), and, more generally, support to those who are in serious financial need might be key, in certain cases, for the effective enforcement of their rights to protection. (100) The rights of the person concerned should be protected in order to avoid reputational damage or other negative consequences. Furthermore, the rights of defence and access to remedies of the person concerned should be fully respected at every stage of the procedure following the report, in accordance with Articles 47 and 48 of the Charter. Member States should protect the confidentiality of the identity of the person concerned and ensure the rights of defence including the right of access to the file, the right to be heard and the right to seek effective remedy against a decision concerning the person concerned under the applicable procedures set out in national law in the context of investigations or subsequent judicial proceedings. (101) Any person who suffers prejudice, whether directly or indirectly, as a consequence of the reporting or public disclosure of inaccurate or misleading information should retain the protection and the remedies available to him or her under the rules of general national law. Where such inaccurate or misleading information was reported or publicly disclosed deliberately and knowingly, the persons concerned should be entitled to compensation in accordance with national law. (102) Criminal, civil or administrative penalties are necessary to ensure the effectiveness of the rules on whistleblower protection. Penalties against those who take retaliatory or other adverse actions against reporting persons can discourage further such actions. Penalties against persons who report or publicly disclose information on breaches which is demonstrated to be knowingly false are also necessary to deter further malicious reporting and preserve the credibility of the system. The proportionality of such penalties should ensure that they do not have a dissuasive effect on potential whistleblowers. (103) Any decision taken by authorities adversely affecting the rights granted by this Directive, in particular decisions by which competent authorities decide to close the procedure regarding a reported breach on account of it being clearly minor or on account of the report being repetitive, or decide that a particular report does not deserve priority treatment, is subject to judicial review in accordance with Article 47 of the Charter. (104) This Directive introduces minimum standards and it should be possible for Member States to introduce or maintain provisions which are more favourable to the reporting person, provided that such provisions do not interfere with the measures for the protection of persons concerned. The transposition of this Directive should, under no circumstances, provide grounds for reducing the level of protection already granted to reporting persons under national law in the areas to which it applies. (105) In accordance with Article 26(2) TFEU, the internal market needs to comprise an area without internal frontiers in which the free movement of goods and services is ensured. The internal market should provide Union citizens with added value in the form of better quality and safety of goods and services, ensuring high standards of public health and environmental protection as well as free movement of personal data. Thus, Article 114 TFEU is the appropriate legal basis to adopt the measures necessary for the establishment and functioning of the internal market. In addition to Article 114 TFEU, this Directive should have additional specific legal bases in order to cover the fields that rely on Article 16, Article 43(2), Article 50, Article 53(1), Articles 91 and 100, Article 168(4), Article 169, Article 192(1) and Article 325(4) TFEU and Article 31 of the Euratom Treaty for the adoption of Union measures. (106) The material scope of this Directive is based on the identification of areas where the introduction of whistleblower protection appears justified and necessary on the basis of currently available evidence. Such material scope could be extended to further areas or Union acts, if that proves necessary as a means of strengthening their enforcement in the light of evidence that may come to the fore in the future, or on the basis of the evaluation of the way in which this Directive has functioned. (107) Where future legislative acts relevant to the policy areas covered by this Directive are adopted, they should specify, where appropriate, that this Directive applies. Where necessary, the material scope of this Directive should be adapted and the Annex should be amended accordingly. (108) Since the objective of this Directive, namely to strengthen enforcement in certain policy areas and as regards acts where breaches of Union law can cause serious harm to the public interest, through effective whistleblower protection, cannot be sufficiently achieved by the Member States acting alone or in an uncoordinated manner, but can rather be better achieved at Union level by laying down common minimum standards for whistleblower protection, and given that only Union action can provide coherence and align the existing Union rules on whistleblower protection, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. (109) This Directive respects fundamental rights and the principles recognised in particular by the Charter, in particular Article 11 thereof. Accordingly, it is essential that this Directive be implemented in accordance with those rights and principles by ensuring full respect for, inter alia, freedom of expression and information, the right to protection of personal data, the freedom to conduct a business, the right to a high level of consumer protection, the right to a high level of human health protection, the right to a high level of environmental protection, the right to good administration, the right to an effective remedy and the rights of defence. (110) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I SCOPE, DEFINITIONS AND CONDITIONS FOR PROTECTION Article 1 Purpose The purpose of this Directive is to enhance the enforcement of Union law and policies in specific areas by laying down common minimum standards providing for a high level of protection of persons reporting breaches of Union law. Article 2 Material scope 1. This Directive lays down common minimum standards for the protection of persons reporting the following breaches of Union law: (a) breaches falling within the scope of the Union acts set out in the Annex that concern the following areas: (i) public procurement; (ii) financial services, products and markets, and prevention of money laundering and terrorist financing; (iii) product safety and compliance; (iv) transport safety; (v) protection of the environment; (vi) radiation protection and nuclear safety; (vii) food and feed safety, animal health and welfare; (viii) public health; (ix) consumer protection; (x) protection of privacy and personal data, and security of network and information systems; (b) breaches affecting the financial interests of the Union as referred to in Article 325 TFEU and as further specified in relevant Union measures; (c) breaches relating to the internal market, as referred to in Article 26(2) TFEU, including breaches of Union competition and State aid rules, as well as breaches relating to the internal market in relation to acts which breach the rules of corporate tax or to arrangements the purpose of which is to obtain a tax advantage that defeats the object or purpose of the applicable corporate tax law. 2. This Directive is without prejudice to the power of Member States to extend protection under national law as regards areas or acts not covered by paragraph 1. Article 3 Relationship with other Union acts and national provisions 1. Where specific rules on the reporting of breaches are provided for in the sector-specific Union acts listed in Part II of the Annex, those rules shall apply. The provisions of this Directive shall be applicable to the extent that a matter is not mandatorily regulated in those sector-specific Union acts. 2. This Directive shall not affect the responsibility of Member States to ensure national security or their power to protect their essential security interests. In particular, it shall not apply to reports of breaches of the procurement rules involving defence or security aspects unless they are covered by the relevant acts of the Union. 3. This Directive shall not affect the application of Union or national law relating to any of the following: (a) the protection of classified information; (b) the protection of legal and medical professional privilege; (c) the secrecy of judicial deliberations; (d) rules on criminal procedure. 4. This Directive shall not affect national rules on the exercise by workers of their rights to consult their representatives or trade unions, and on protection against any unjustified detrimental measure prompted by such consultations as well as on the autonomy of the social partners and their right to enter into collective agreements. This is without prejudice to the level of protection granted by this Directive. Article 4 Personal scope 1. This Directive shall apply to reporting persons working in the private or public sector who acquired information on breaches in a work-related context including, at least, the following: (a) persons having the status of worker, within the meaning of Article 45(1) TFEU, including civil servants; (b) persons having self-employed status, within the meaning of Article 49 TFEU; (c) shareholders and persons belonging to the administrative, management or supervisory body of an undertaking, including non-executive members, as well as volunteers and paid or unpaid trainees; (d) any persons working under the supervision and direction of contractors, subcontractors and suppliers. 2. This Directive shall also apply to reporting persons where they report or publicly disclose information on breaches acquired in a work-based relationship which has since ended. 3. This Directive shall also apply to reporting persons whose work-based relationship is yet to begin in cases where information on breaches has been acquired during the recruitment process or other pre-contractual negotiations. 4. The measures for the protection of reporting persons set out in Chapter VI shall also apply, where relevant, to: (a) facilitators; (b) third persons who are connected with the reporting persons and who could suffer retaliation in a work-related context, such as colleagues or relatives of the reporting persons; and (c) legal entities that the reporting persons own, work for or are otherwise connected with in a work-related context. Article 5 Definitions For the purposes of this Directive, the following definitions apply: (1) ‘breaches’ means acts or omissions that: (i) are unlawful and relate to the Union acts and areas falling within the material scope referred to in Article 2; or (ii) defeat the object or the purpose of the rules in the Union acts and areas falling within the material scope referred to in Article 2; (2) ‘information on breaches’ means information, including reasonable suspicions, about actual or potential breaches, which occurred or are very likely to occur in the organisation in which the reporting person works or has worked or in another organisation with which the reporting person is or was in contact through his or her work, and about attempts to conceal such breaches; (3) ‘report’ or ‘to report’ means, the oral or written communication of information on breaches; (4) ‘internal reporting’ means the oral or written communication of information on breaches within a legal entity in the private or public sector; (5) ‘external reporting’ means the oral or written communication of information on breaches to the competent authorities; (6) ‘public disclosure’ or ‘to publicly disclose’ means the making of information on breaches available in the public domain; (7) ‘reporting person’ means a natural person who reports or publicly discloses information on breaches acquired in the context of his or her work-related activities; (8) ‘facilitator’ means a natural person who assists a reporting person in the reporting process in a work-related context, and whose assistance should be confidential; (9) ‘work-related context’ means current or past work activities in the public or private sector through which, irrespective of the nature of those activities, persons acquire information on breaches and within which those persons could suffer retaliation if they reported such information; (10) ‘person concerned’ means a natural or legal person who is referred to in the report or public disclosure as a person to whom the breach is attributed or with whom that person is associated; (11) ‘retaliation’ means any direct or indirect act or omission which occurs in a work-related context, is prompted by internal or external reporting or by public disclosure, and which causes or may cause unjustified detriment to the reporting person; (12) ‘follow-up’ means any action taken by the recipient of a report or any competent authority, to assess the accuracy of the allegations made in the report and, where relevant, to address the breach reported, including through actions such as an internal enquiry, an investigation, prosecution, an action for recovery of funds, or the closure of the procedure; (13) ‘feedback’ means the provision to the reporting person of information on the action envisaged or taken as follow-up and on the grounds for such follow-up; (14) ‘competent authority’ means any national authority designated to receive reports in accordance with Chapter III and give feedback to the reporting person, and/or designated to carry out the duties provided for in this Directive, in particular as regards follow-up. Article 6 Conditions for protection of reporting persons 1. Reporting persons shall qualify for protection under this Directive provided that: (a) they had reasonable grounds to believe that the information on breaches reported was true at the time of reporting and that such information fell within the scope of this Directive; and (b) they reported either internally in accordance with Article 7 or externally in accordance with Article 10, or made a public disclosure in accordance with Article 15. 2. Without prejudice to existing obligations to provide for anonymous reporting by virtue of Union law, this Directive does not affect the power of Member States to decide whether legal entities in the private or public sector and competent authorities are required to accept and follow up on anonymous reports of breaches. 3. Persons who reported or publicly disclosed information on breaches anonymously, but who are subsequently identified and suffer retaliation, shall nonetheless qualify for the protection provided for under Chapter VI, provided that they meet the conditions laid down in paragraph 1. 4. Persons reporting to relevant institutions, bodies, offices or agencies of the Union breaches falling within the scope of this Directive shall qualify for protection as laid down in this Directive under the same conditions as persons who report externally. CHAPTER II INTERNAL REPORTING AND FOLLOW-UP Article 7 Reporting through internal reporting channels 1. As a general principle and without prejudice to Articles 10 and 15, information on breaches may be reported through the internal reporting channels and procedures provided for in this Chapter. 2. Member States shall encourage reporting through internal reporting channels before reporting through external reporting channels, where the breach can be addressed effectively internally and where the reporting person considers that there is no risk of retaliation. 3. Appropriate information relating to the use of internal reporting channels referred to in paragraph 2 shall be provided in the context of the information given by legal entities in the private and public sector pursuant to point (g) of Article 9(1), and by competent authorities pursuant to point (a) of Article 12(4) and Article 13. Article 8 Obligation to establish internal reporting channels 1. Member States shall ensure that legal entities in the private and public sector establish channels and procedures for internal reporting and for follow-up, following consultation and in agreement with the social partners where provided for by national law. 2. The channels and procedures referred to in paragraph 1 of this Article shall enable the entity's workers to report information on breaches. They may enable other persons, referred to in points (b), (c) and (d) of Article 4(1) and Article 4(2), who are in contact with the entity in the context of their work-related activities to also report information on breaches. 3. Paragraph 1 shall apply to legal entities in the private sector with 50 or more workers. 4. The threshold laid down in paragraph 3 shall not apply to the entities falling within the scope of Union acts referred to in Parts I.B and II of the Annex. 5. Reporting channels may be operated internally by a person or department designated for that purpose or provided externally by a third party. The safeguards and requirements referred to in Article 9(1) shall also apply to entrusted third parties operating the reporting channel for a legal entity in the private sector. 6. Legal entities in the private sector with 50 to 249 workers may share resources as regards the receipt of reports and any investigation to be carried out. This shall be without prejudice to the obligations imposed upon such entities by this Directive to maintain confidentiality, to give feedback, and to address the reported breach. 7. Following an appropriate risk assessment taking into account the nature of the activities of the entities and the ensuing level of risk for, in particular, the environment and public health, Member States may require legal entities in the private sector with fewer than 50 workers to establish internal reporting channels and procedures in accordance with Chapter II. 8. Member States shall notify the Commission of any decision they take to require legal entities in the private sector to establish internal reporting channels pursuant to paragraph 7. That notification shall include the reasons for the decision and the criteria used in the risk assessment referred to in paragraph 7. The Commission shall communicate that decision to the other Member States. 9. Paragraph 1 shall apply to all legal entities in the public sector, including any entity owned or controlled by such entities. Member States may exempt from the obligation referred to in paragraph 1 municipalities with fewer than 10 000 inhabitants or fewer than 50 workers, or other entities referred to in the first subparagraph of this paragraph with fewer than 50 workers. Member States may provide that internal reporting channels can be shared between municipalities or operated by joint municipal authorities in accordance with national law, provided that the shared internal reporting channels are distinct from and autonomous in relation to the relevant external reporting channels. Article 9 Procedures for internal reporting and follow-up 1. The procedures for internal reporting and for follow-up as referred to in Article 8 shall include the following: (a) channels for receiving the reports which are designed, established and operated in a secure manner that ensures that the confidentiality of the identity of the reporting person and any third party mentioned in the report is protected, and prevents access thereto by non-authorised staff members; (b) acknowledgment of receipt of the report to the reporting person within seven days of that receipt; (c) the designation of an impartial person or department competent for following-up on the reports which may be the same person or department as the one that receives the reports and which will maintain communication with the reporting person and, where necessary, ask for further information from and provide feedback to that reporting person; (d) diligent follow-up by the designated person or department referred to in point (c); (e) diligent follow-up, where provided for in national law, as regards anonymous reporting; (f) a reasonable timeframe to provide feedback, not exceeding three months from the acknowledgment of receipt or, if no acknowledgement was sent to the reporting person, three months from the expiry of the seven-day period after the report was made; (g) provision of clear and easily accessible information regarding the procedures for reporting externally to competent authorities pursuant to Article 10 and, where relevant, to institutions, bodies, offices or agencies of the Union. 2. The channels provided for in point (a) of paragraph 1 shall enable reporting in writing or orally, or both. Oral reporting shall be possible by telephone or through other voice messaging systems, and, upon request by the reporting person, by means of a physical meeting within a reasonable timeframe. CHAPTER III EXTERNAL REPORTING AND FOLLOW-UP Article 10 Reporting through external reporting channels Without prejudice to point (b) of Article 15(1), reporting persons shall report information on breaches using the channels and procedures referred to in Articles 11 and 12, after having first reported through internal reporting channels, or by directly reporting through external reporting channels. Article 11 Obligation to establish external reporting channels and to follow up on reports 1. Member States shall designate the authorities competent to receive, give feedback and follow up on reports, and shall provide them with adequate resources. 2. Member States shall ensure that the competent authorities: (a) establish independent and autonomous external reporting channels, for receiving and handling information on breaches; (b) promptly, and in any event within seven days of receipt of the report, acknowledge that receipt unless the reporting person explicitly requested otherwise or the competent authority reasonably believes that acknowledging receipt of the report would jeopardise the protection of the reporting person's identity; (c) diligently follow up on the reports; (d) provide feedback to the reporting person within a reasonable timeframe not exceeding three months, or six months in duly justified cases; (e) communicate to the reporting person the final outcome of investigations triggered by the report, in accordance with procedures provided for under national law; (f) transmit in due time the information contained in the report to competent institutions, bodies, offices or agencies of the Union, as appropriate, for further investigation, where provided for under Union or national law. 3. Member States may provide that competent authorities, after having duly assessed the matter, can decide that a reported breach is clearly minor and does not require further follow-up pursuant to this Directive, other than closure of the procedure. This shall not affect other obligations or other applicable procedures to address the reported breach, or the protection granted by this Directive in relation to internal or external reporting. In such a case, the competent authorities shall notify the reporting person of their decision and the reasons therefor. 4. Member States may provide that competent authorities can decide to close procedures regarding repetitive reports which do not contain any meaningful new information on breaches compared to a past report in respect of which the relevant procedures were concluded, unless new legal or factual circumstances justify a different follow-up. In such a case, the competent authorities shall notify the reporting person of their decision and the reasons therefor. 5. Member States may provide that, in the event of high inflows of reports, competent authorities may deal with reports of serious breaches or breaches of essential provisions falling within the scope of this Directive as a matter of priority, without prejudice to the timeframe as set out in point (d) of paragraph 2. 6. Member States shall ensure that any authority which has received a report but does not have the competence to address the breach reported transmits it to the competent authority, within a reasonable time, in a secure manner, and that the reporting person is informed, without delay, of such a transmission. Article 12 Design of external reporting channels 1. External reporting channels shall be considered independent and autonomous, if they meet all of the following criteria: (a) they are designed, established and operated in a manner that ensures the completeness, integrity and confidentiality of the information and prevents access thereto by non-authorised staff members of the competent authority; (b) they enable the durable storage of information in accordance with Article 18 to allow further investigations to be carried out. 2. The external reporting channels shall enable reporting in writing and orally. Oral reporting shall be possible by telephone or through other voice messaging systems and, upon request by the reporting person, by means of a physical meeting within a reasonable timeframe. 3. Competent authorities shall ensure that, where a report is received through channels other than the reporting channels referred to in paragraphs 1 and 2 or by staff members other than those responsible for handling reports, the staff members who receive it are prohibited from disclosing any information that might identify the reporting person or the person concerned, and that they promptly forward the report without modification to the staff members responsible for handling reports. 4. Member States shall ensure that competent authorities designate staff members responsible for handling reports, and in particular for: (a) providing any interested person with information on the procedures for reporting; (b) receiving and following up on reports; (c) maintaining contact with the reporting person for the purpose of providing feedback and requesting further information where necessary. 5. The staff members referred to in paragraph 4 shall receive specific training for the purposes of handling reports. Article 13 Information regarding the receipt of reports and their follow-up Member States shall ensure that competent authorities publish on their websites in a separate, easily identifiable and accessible section at least the following information: (a) the conditions for qualifying for protection under this Directive; (b) the contact details for the external reporting channels as provided for under Article 12, in particular the electronic and postal addresses, and the phone numbers for such channels, indicating whether the phone conversations are recorded; (c) the procedures applicable to the reporting of breaches, including the manner in which the competent authority may request the reporting person to clarify the information reported or to provide additional information, the timeframe for providing feedback and the type and content of such feedback; (d) the confidentiality regime applicable to reports, and in particular the information in relation to the processing of personal data in accordance with Article 17 of this Directive, Articles 5 and 13 of Regulation (EU) 2016/679, Article 13 of Directive (EU) 2016/680 and Article 15 of Regulation (EU) 2018/1725, as applicable; (e) the nature of the follow-up to be given to reports; (f) the remedies and procedures for protection against retaliation and the availability of confidential advice for persons contemplating reporting; (g) a statement clearly explaining the conditions under which persons reporting to the competent authority are protected from incurring liability for a breach of confidentiality pursuant to Article 21(2); and (h) contact details of the information centre or of the single independent administrative authority as provided for in Article 20(3) where applicable. Article 14 Review of the procedures by competent authorities Member States shall ensure that competent authorities review their procedures for receiving reports, and their follow-up, regularly, and at least once every three years. In reviewing such procedures, competent authorities shall take account of their experience as well as that of other competent authorities and adapt their procedures accordingly. CHAPTER IV PUBLIC DISCLOSURES Article 15 Public disclosures 1. A person who makes a public disclosure shall qualify for protection under this Directive if any of the following conditions is fulfilled: (a) the person first reported internally and externally, or directly externally in accordance with Chapters II and III, but no appropriate action was taken in response to the report within the timeframe referred to in point (f) of Article 9(1) or point (d) of Article 11(2); or (b) the person has reasonable grounds to believe that: (i) the breach may constitute an imminent or manifest danger to the public interest, such as where there is an emergency situation or a risk of irreversible damage; or (ii) in the case of external reporting, there is a risk of retaliation or there is a low prospect of the breach being effectively addressed, due to the particular circumstances of the case, such as those where evidence may be concealed or destroyed or where an authority may be in collusion with the perpetrator of the breach or involved in the breach. 2. This Article shall not apply to cases where a person directly discloses information to the press pursuant to specific national provisions establishing a system of protection relating to freedom of expression and information. CHAPTER V PROVISIONS APPLICABLE TO INTERNAL AND EXTERNAL REPORTING Article 16 Duty of confidentiality 1. Member States shall ensure that the identity of the reporting person is not disclosed to anyone beyond the authorised staff members competent to receive or follow up on reports, without the explicit consent of that person. This shall also apply to any other information from which the identity of the reporting person may be directly or indirectly deduced. 2. By way of derogation from paragraph 1, the identity of the reporting person and any other information referred to in paragraph 1 may be disclosed only where this is a necessary and proportionate obligation imposed by Union or national law in the context of investigations by national authorities or judicial proceedings, including with a view to safeguarding the rights of defence of the person concerned. 3. Disclosures made pursuant to the derogation provided for in paragraph 2 shall be subject to appropriate safeguards under the applicable Union and national rules. In particular, reporting persons shall be informed before their identity is disclosed, unless such information would jeopardise the related investigations or judicial proceedings. When informing the reporting persons, the competent authority shall send them an explanation in writing of the reasons for the disclosure of the confidential data concerned. 4. Member States shall ensure that competent authorities that receive information on breaches that includes trade secrets do not use or disclose those trade secrets for purposes going beyond what is necessary for proper follow-up. Article 17 Processing of personal data Any processing of personal data carried out pursuant to this Directive, including the exchange or transmission of personal data by the competent authorities, shall be carried out in accordance with Regulation (EU) 2016/679 and Directive (EU) 2016/680. Any exchange or transmission of information by Union institutions, bodies, offices or agencies shall be undertaken in accordance with Regulation (EU) 2018/1725. Personal data which are manifestly not relevant for the handling of a specific report shall not be collected or, if accidentally collected, shall be deleted without undue delay. Article 18 Record keeping of the reports 1. Member States shall ensure that legal entities in the private and public sector and competent authorities keep records of every report received, in compliance with the confidentiality requirements provided for in Article 16. Reports shall be stored for no longer than it is necessary and proportionate in order to comply with the requirements imposed by this Directive, or other requirements imposed by Union or national law. 2. Where a recorded telephone line or another recorded voice messaging system is used for reporting, subject to the consent of the reporting person, legal entities in the private and public sector and competent authorities shall have the right to document the oral reporting in one of the following ways: (a) by making a recording of the conversation in a durable and retrievable form; or (b) through a complete and accurate transcript of the conversation prepared by the staff members responsible for handling the report. Legal entities in the private and public sector and competent authorities shall offer the reporting person the opportunity to check, rectify and agree the transcript of the call by signing it. 3. Where an unrecorded telephone line or another unrecorded voice messaging system is used for reporting, legal entities in the private and public sector and competent authorities shall have the right to document the oral reporting in the form of accurate minutes of the conversation written by the staff member responsible for handling the report. Legal entities in the private and public sector and competent authorities shall offer the reporting person the opportunity to check, rectify and agree the minutes of the conversation by signing them. 4. Where a person requests a meeting with the staff members of legal entities in the private and public sector or of competent authorities for reporting purposes pursuant to Articles 9(2) and 12(2), legal entities in the private and public sector and competent authorities shall ensure, subject to the consent of the reporting person, that complete and accurate records of the meeting are kept in a durable and retrievable form. Legal entities in the private and public sector and competent authorities shall have the right to document the meeting in one of the following ways: (a) by making a recording of the conversation in a durable and retrievable form; or (b) through accurate minutes of the meeting prepared by the staff members responsible for handling the report. Legal entities in the private and public sector and competent authorities shall offer the reporting person the opportunity to check, rectify and agree the minutes of the meeting by signing them. CHAPTER VI PROTECTION MEASURES Article 19 Prohibition of retaliation Member States shall take the necessary measures to prohibit any form of retaliation against persons referred to in Article 4, including threats of retaliation and attempts of retaliation including in particular in the form of: (a) suspension, lay-off, dismissal or equivalent measures; (b) demotion or withholding of promotion; (c) transfer of duties, change of location of place of work, reduction in wages, change in working hours; (d) withholding of training; (e) a negative performance assessment or employment reference; (f) imposition or administering of any disciplinary measure, reprimand or other penalty, including a financial penalty; (g) coercion, intimidation, harassment or ostracism; (h) discrimination, disadvantageous or unfair treatment; (i) failure to convert a temporary employment contract into a permanent one, where the worker had legitimate expectations that he or she would be offered permanent employment; (j) failure to renew, or early termination of, a temporary employment contract; (k) harm, including to the person's reputation, particularly in social media, or financial loss, including loss of business and loss of income; (l) blacklisting on the basis of a sector or industry-wide informal or formal agreement, which may entail that the person will not, in the future, find employment in the sector or industry; (m) early termination or cancellation of a contract for goods or services; (n) cancellation of a licence or permit; (o) psychiatric or medical referrals. Article 20 Measures of support 1. Member States shall ensure that persons referred to in Article 4 have access, as appropriate, to support measures, in particular the following: (a) comprehensive and independent information and advice, which is easily accessible to the public and free of charge, on procedures and remedies available, on protection against retaliation, and on the rights of the person concerned; (b) effective assistance from competent authorities before any relevant authority involved in their protection against retaliation, including, where provided for under national law, certification of the fact that they qualify for protection under this Directive; and (c) legal aid in criminal and in cross-border civil proceedings in accordance with Directive (EU) 2016/1919 and Directive 2008/52/EC of the European Parliament and of the Council (48), and, in accordance with national law, legal aid in further proceedings and legal counselling or other legal assistance. 2. Member States may provide for financial assistance and support measures, including psychological support, for reporting persons in the framework of legal proceedings. 3. The support measures referred to in this Article may be provided, as appropriate, by an information centre or a single and clearly identified independent administrative authority. Article 21 Measures for protection against retaliation 1. Member States shall take the necessary measures to ensure that persons referred to in Article 4 are protected against retaliation. Such measures shall include, in particular, those set out in paragraphs 2 to 8 of this Article. 2. Without prejudice to Article 3(2) and (3), where persons report information on breaches or make a public disclosure in accordance with this Directive they shall not be considered to have breached any restriction on disclosure of information and shall not incur liability of any kind in respect of such a report or public disclosure provided that they had reasonable grounds to believe that the reporting or public disclosure of such information was necessary for revealing a breach pursuant to this Directive. 3. Reporting persons shall not incur liability in respect of the acquisition of or access to the information which is reported or publicly disclosed, provided that such acquisition or access did not constitute a self-standing criminal offence. In the event of the acquisition or access constituting a self-standing criminal offence, criminal liability shall continue to be governed by applicable national law. 4. Any other possible liability of reporting persons arising from acts or omissions which are unrelated to the reporting or public disclosure or which are not necessary for revealing a breach pursuant to this Directive shall continue to be governed by applicable Union or national law. 5. In proceedings before a court or other authority relating to a detriment suffered by the reporting person, and subject to that person establishing that he or she reported or made a public disclosure and suffered a detriment, it shall be presumed that the detriment was made in retaliation for the report or the public disclosure. In such cases, it shall be for the person who has taken the detrimental measure to prove that that measure was based on duly justified grounds. 6. Persons referred to in Article 4 shall have access to remedial measures against retaliation as appropriate, including interim relief pending the resolution of legal proceedings, in accordance with national law. 7. In legal proceedings, including for defamation, breach of copyright, breach of secrecy, breach of data protection rules, disclosure of trade secrets, or for compensation claims based on private, public, or on collective labour law, persons referred to in Article 4 shall not incur liability of any kind as a result of reports or public disclosures under this Directive. Those persons shall have the right to rely on that reporting or public disclosure to seek dismissal of the case, provided that they had reasonable grounds to believe that the reporting or public disclosure was necessary for revealing a breach, pursuant to this Directive. Where a person reports or publicly discloses information on breaches falling within the scope of this Directive, and that information includes trade secrets, and where that person meets the conditions of this Directive, such reporting or public disclosure shall be considered lawful under the conditions of Article 3(2) of the Directive (EU) 2016/943. 8. Member States shall take the necessary measures to ensure that remedies and full compensation are provided for damage suffered by persons referred to in Article 4 in accordance with national law. Article 22 Measures for the protection of persons concerned 1. Member States shall ensure, in accordance with the Charter, that persons concerned fully enjoy the right to an effective remedy and to a fair trial, as well as the presumption of innocence and the rights of defence, including the right to be heard and the right to access their file. 2. Competent authorities shall ensure, in accordance with national law, that the identity of persons concerned is protected for as long as investigations triggered by the report or the public disclosure are ongoing. 3. The rules set out in Articles 12, 17 and 18 as regards the protection of the identity of reporting persons shall also apply to the protection of the identity of persons concerned. Article 23 Penalties 1. Member States shall provide for effective, proportionate and dissuasive penalties applicable to natural or legal persons that: (a) hinder or attempt to hinder reporting; (b) retaliate against persons referred to in Article 4; (c) bring vexatious proceedings against persons referred to in Article 4; (d) breach the duty of maintaining the confidentiality of the identity of reporting persons, as referred to in Article 16. 2. Member States shall provide for effective, proportionate and dissuasive penalties applicable in respect of reporting persons where it is established that they knowingly reported or publicly disclosed false information. Member States shall also provide for measures for compensating damage resulting from such reporting or public disclosures in accordance with national law. Article 24 No waiver of rights and remedies Member States shall ensure that the rights and remedies provided for under this Directive cannot be waived or limited by any agreement, policy, form or condition of employment, including a pre-dispute arbitration agreement. CHAPTER VII FINAL PROVISIONS Article 25 More favourable treatment and non-regression clause 1. Member States may introduce or retain provisions more favourable to the rights of reporting persons than those set out in this Directive, without prejudice to Article 22 and Article 23(2). 2. The implementation of this Directive shall under no circumstances constitute grounds for a reduction in the level of protection already afforded by Member States in the areas covered by this Directive. Article 26 Transposition and transitional period 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 17 December 2021. 2. By way of derogation from paragraph 1, as regards legal entities in the private sector with 50 to 249 workers, Member States shall by 17 December 2023 bring into force the laws, regulations and administrative provisions necessary to comply with the obligation to establish internal reporting channels under Article 8(3). 3. When Member States adopt the provisions referred to in paragraphs 1 and 2, those provisions shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. They shall forthwith communicate to the Commission the text of those provisions. Article 27 Reporting, evaluation and review 1. Member States shall provide the Commission with all relevant information regarding the implementation and application of this Directive. On the basis of the information provided, the. Commission shall, by 17 December 2023, submit a report to the European Parliament and the Council on the implementation and application of this Directive. 2. Without prejudice to reporting obligations laid down in other Union legal acts, Member States shall, on an annual basis, submit the following statistics on the reports referred to in Chapter III to the Commission, preferably in an aggregated form, if they are available at a central level in the Member State concerned: (a) the number of reports received by the competent authorities; (b) the number of investigations and proceedings initiated as a result of such reports and their outcome; and (c) if ascertained, the estimated financial damage, and the amounts recovered following investigations and proceedings, related to the breaches reported. 3. The Commission shall, by 17 December 2025, taking into account its report submitted pursuant to paragraph 1 and the Member States' statistics submitted pursuant to paragraph 2, submit a report to the European Parliament and to the Council assessing the impact of national law transposing this Directive. The report shall evaluate the way in which this Directive has functioned and consider the need for additional measures, including, where appropriate, amendments with a view to extending the scope of this Directive to further Union acts or areas, in particular the improvement of the working environment to protect workers' health and safety and working conditions. In addition to the evaluation referred to in the first subparagraph, the report shall evaluate how Member States made use of existing cooperation mechanisms as part of their obligations to follow up on reports regarding breaches falling within the scope of this Directive and more generally how they cooperate in cases of breaches with a cross-border dimension. 4. The Commission shall make the reports referred to in paragraphs 1 and 3 public and easily accessible. Article 28 Entry into force This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 29 Addressees This Directive is addressed to the Member States. Done at Strasbourg, 23 October 2019. For the European Parliament The President D. M. SASSOLI For the Council The President T. TUPPURAINEN (1) OJ C 405, 9.11.2018, p. 1. (2) OJ C 62, 15.2.2019, p. 155. (3) Position of the European Parliament of 16 April 2019 (not yet published in the Official Journal) and decision of the Council of 7 October 2019. (4) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338). (5) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). (6) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011(OJ L 169, 25.6.2019, p. 1). (7) Directive 2001/95/EC of the European Parliament and of the Council, of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4). (8) Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18). (9) Directive 2013/54/EU of the European Parliament and of the Council of 20 November 2013 concerning certain flag State responsibilities for compliance with and enforcement of the Maritime Labour Convention, 2006 (OJ L 329, 10.12.2013, p. 1). (10) Directive 2009/16/EC of the European Parliament and of the Council of 23 April 2009 on port State control (OJ L 131, 28.5.2009, p. 57). (11) Directive 2013/30/EU of the European Parliament and of the Council of 12 June 2013, on safety of offshore oil and gas operations and amending Directive 2004/35/EC (OJ L 178, 28.6.2013, p. 66). (12) Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations (OJ L 172, 2.7.2009, p. 18). (13) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). (14) Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1). (15) Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23). (16) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33). (17) Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1). (18) Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, p. 1). (19) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1). (20) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (21) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (22) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union's financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (23) OJ C 316, 27.11.1995, p. 49. (24) OJ C 313, 23.10.1996, p. 2. (25) OJ C 151, 20.5.1997, p. 2. (26) OJ C 221, 19.7.1997, p. 2. (27) Commission Regulation (EC) No 773/2004 of 7 April 2004 relating to the conduct of proceedings by the Commission pursuant to Articles 81 and 82 of the EC Treaty (OJ L 123, 27.4.2004, p. 18). (28) Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC (OJ L 173, 12.6.2014, p. 1). (29) Commission Implementing Directive (EU) 2015/2392 of 17 December 2015 on Regulation (EU) No 596/2014 of the European Parliament and of the Council as regards reporting to competent authorities of actual or potential infringements of that Regulation (OJ L 332, 18.12.2015, p. 126). (30) Regulation (EU) No 1286/2014 of the European Parliament and of the Council of 26 November 2014 on key information documents for packaged retail and insurance-based investment products (PRIIPs) (OJ L 352, 9.12.2014, p. 1). (31) Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1). (32) OJ L 56, 4.3.1968, p. 1. (33) Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1). (34) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). (35) Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (OJ L 1, 4.1.2003, p. 1). (36) Commission Implementing Decision (EU) 2015/1918 of 22 October 2015 establishing the Administrative Assistance and Cooperation system (‘AAC system’) pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 280, 24.10.2015, p. 31). (37) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1). (38) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). (39) Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws (the Regulation on consumer protection cooperation) (OJ L 364, 9.12.2004, p. 1). (40) Commission Decision of 18 January 2018 setting up a group of experts on environmental compliance and governance (OJ C 19, 19.1.2018, p. 3). (41) Council Directive 2011/16/EU of 15 February 2011 on administrative cooperation in the field of taxation and repealing Directive 77/799/EEC (OJ L 64, 11.3.2011, p. 1). (42) Directive 2012/13/EU of the European Parliament and of the Council of 22 May 2012 on the right to information in criminal proceedings (OJ L 142, 1.6.2012, p. 1). (43) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (44) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (45) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (46) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1). (47) Directive (EU) 2016/1919 of the European Parliament and of the Council of 26 October 2016 on legal aid for suspects and accused persons in criminal proceedings and for requested persons in European arrest warrant proceedings (OJ L 297, 4.11.2016, p. 1). (48) Directive 2008/52/EC of the European Parliament and of the Council of 21 May 2008 on certain aspects of mediation in civil and commercial matters (OJ L 136, 24.5.2008, p. 3). ANNEX Part I A. Point (a)(i) of Article 2(1) — public procurement: 1. Rules of procedure for public procurement and the award of concessions, for the award of contracts in the fields of defence and security, and for the award of contracts by entities operating in the fields of water, energy, transport and postal services and any other contract, as set out in: (i) Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts (OJ L 94, 28.3.2014, p. 1); (ii) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65); (iii) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243); (iv) Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security, and amending Directives 2004/17/EC and 2004/18/EC (OJ L 216, 20.8.2009, p. 76). 2. Review procedures regulated by: (i) Council Directive 92/13/EEC of 25 February 1992 coordinating the laws, regulations and administrative provisions relating to the application of Community rules on the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors (OJ L 76, 23.3.1992, p. 14); (ii) Council Directive 89/665/EEC of 21 December 1989 on the coordination of the laws, regulations and administrative provisions relating to the application of review procedures to the award of public supply and public works contracts (OJ L 395, 30.12.1989, p. 33). B. Point (a)(ii) of Article 2(1) — financial services, products and markets, and prevention of money laundering and terrorist financing: Rules establishing a regulatory and supervisory framework and consumer and investor protection in the Union's financial services and capital markets, banking, credit, investment, insurance and re-insurance, occupational or personal pensions products, securities, investment funds, payment services and the activities listed in Annex I to Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338), as set out in: (i) Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions amending Directives 2005/60/EC and 2006/48/EC and repealing Directive 2000/46/EC (OJ L 267, 10.10.2009, p. 7); (ii) Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010 (OJ L 174, 1.7.2011, p. 1); (iii) Regulation (EU) No 236/2012 of the European Parliament and of the Council of 14 March 2012 on short selling and certain aspects of credit default swaps (OJ L 86, 24.3.2012, p. 1); (iv) Regulation (EU) No 345/2013 of the European Parliament and of the Council of 17 April 2013 on European venture capital funds (OJ L 115, 25.4.2013, p. 1); (v) Regulation (EU) No 346/2013 of the European Parliament and of the Council of 17 April 2013 on European social entrepreneurship fund (OJ L 115, 25.4.2013, p. 18); (vi) Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (OJ L 60, 28.2.2014, p. 34); (vii) Regulation (EU) No 537/2014 of the European Parliament and of the Council of 16 April 2014 on specific requirements regarding statutory audit of public-interest entities and repealing Commission Decision 2005/909/EC (OJ L 158, 27.5.2014, p. 77); (viii) Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84); (ix) Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (OJ L 337, 23.12.2015, p. 35); (x) Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids (OJ L 142, 30.4.2004, p. 12); (xi) Directive 2007/36/EC of the European Parliament and of the Council of 11 July 2007 on the exercise of certain rights of shareholders in listed companies (OJ L 184, 14.7.2007, p. 17); (xii) Directive 2004/109/EC of the European Parliament and of the Council of 15 December 2004 on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC (OJ L 390, 31.12.2004, p. 38); (xiii) Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (OJ L 201, 27.7.2012, p. 1); (xiv) Regulation (EU) 2016/1011 of the European Parliament and of the Council of 8 June 2016 on indices used as benchmarks in financial instruments and financial contracts or to measure the performance of investment funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014 (OJ L 171, 29.6.2016, p. 1); (xv) Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1); (xvi) Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (OJ L 173, 12.6.2014, p. 190); (xvii) Directive 2002/87/EC of the European Parliament and of the Council of 16 December 2002 on the supplementary supervision of credit institutions, insurance undertakings and investment firms in a financial conglomerate and amending Council Directives 73/239/EEC, 79/267/EEC, 92/49/EEC, 92/96/EEC, 93/6/EEC and 93/22/EEC, and Directives 98/78/EC and 2000/12/EC of the European Parliament and of the Council (OJ L 35, 11.2.2003, p. 1); (xviii) Directive 2014/49/EU of the European Parliament and of the Council of 16 April 2014 on deposit guarantee schemes (OJ L 173, 12.6.2014, p. 149); (xix) Directive 97/9/EC of the European Parliament and of the Council of 3 March 1997 on investor-compensation schemes (OJ L 84, 26.3.1997, p. 22); (xx) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1). C. Point (a)(iii) of Article 2(1) — product safety and compliance: 1. Safety and compliance requirements for products placed in the Union market, as defined and regulated by: (i) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4); (ii) Union harmonisation legislation concerning manufactured products, including labelling requirements, other than food, feed, medicinal products for human and veterinary use, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction as listed in Annexes I and II to Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1); (iii) Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (OJ L 263, 9.10.2007, p. 1). 2. Rules on marketing and use of sensitive and dangerous products, as set out in: (i) Directive 2009/43/EC of the European Parliament and of the Council of 6 May 2009 simplifying terms and conditions of transfers of defence-related products within the Community (OJ L 146, 10.6.2009, p. 1); (ii) Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons (OJ L 256, 13.9.1991, p. 51); (iii) Regulation (EU) No 98/2013 of the European Parliament and the Council of 15 January 2013 on the marketing and use of explosives precursors (OJ L 39, 9.2.2013, p. 1). D. Point (a)(iv) of Article 2(1) — transport safety: 1. Safety requirements in the railway sector, as regulated by Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety (OJ L 138, 26.5.2016, p. 102). 2. Safety requirements in the civil aviation sector, as regulated by Regulation (EU) No 996/2010 of the European Parliament and of the Council of 20 October 2010 on the investigation and prevention of accidents and incidents in civil aviation and repealing Directive 94/56/EC (OJ L 295, 12.11.2010, p. 35). 3. Safety requirements in the road sector, as regulated by: (i) Directive 2008/96/EC of the European Parliament and of the Council of 19 November 2008 on road infrastructure safety management (OJ L 319, 29.11.2008, p. 59); (ii) Directive 2004/54/EC of the European Parliament and of the Council of 29 April 2004 on minimum safety requirements for tunnels in the Trans-European Road Network (OJ L 167, 30.4.2004, p. 39); (iii) Regulation (EC) No 1071/2009 of the European Parliament and of the Council of 21 October 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing Council Directive 96/26/EC (OJ L 300, 14.11.2009, p. 51). 4. Safety requirements in the maritime sector, as regulated by: (i) Regulation (EC) No 391/2009 of the European Parliament and of the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations (OJ L 131, 28.5.2009, p. 11); (ii) Regulation (EC) No 392/2009 of the European Parliament and of the Council of 23 April 2009 on the liability of carriers of passengers by sea in the event of accidents (OJ L 131, 28.5.2009, p. 24); (iii) Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146); (iv) Directive 2009/18/EC of the European Parliament and of the Council of 23 April 2009 establishing the fundamental principles governing the investigation of accidents in the maritime transport sector and amending Council Directive 1999/35/EC and Directive 2002/59/EC (OJ L 131, 28.5.2009, p. 114); (v) Directive 2008/106/EC of the European Parliament and of the Council of 19 November 2008 on the minimum level of training of seafarers (OJ L 323, 3.12.2008, p. 33); (vi) Council Directive 98/41/EC of 18 June 1998 on the registration of persons sailing on board passenger ships operating to or from ports of the Member States of the Community (OJ L 188, 2.7.1998, p. 35); (vii) Directive 2001/96/EC of the European Parliament and of the Council of 4 December 2001 establishing harmonised requirements and procedures for the safe loading and unloading of bulk carriers (OJ L 13, 16.1.2002, p. 9). 5. Safety requirements, as regulated by Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13). E. Point (a)(v) of Article 2(1) — protection of the environment: 1. Any criminal offence against the protection of the environment as regulated by Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law (OJ L 328, 6.12.2008, p. 28) or any unlawful conduct infringing the legislation set out in the Annexes to Directive 2008/99/EC; 2. Rules on the environment and climate, as set out in: (i) Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32); (ii) Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140, 5.6.2009, p. 16); (iii) Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1); (iv) Regulation (EU) No 525/2013 of the European Parliament and of the Council of 21 May 2013 on a mechanism for monitoring and reporting greenhouse gas emissions and for reporting other information at national and Union level relevant to climate change and repealing Decision No 280/2004/EC (OJ L 165, 18.6.2013, p. 13); (v) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82). 3. Rules on sustainable development and waste management, as set out in: (i) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3); (ii) Regulation (EU) No 1257/2013 of the European Parliament and of the Council of 20 November 2013 on ship recycling and amending Regulation (EC) No 1013/2006 and Directive 2009/16/EC (OJ L 330, 10.12.2013, p. 1); (iii) Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p. 60). 4. Rules on marine, air and noise pollution, as set out in: (i) Directive 1999/94/EC of the European Parliament and of the Council of 13 December 1999 relating to the availability of consumer information on fuel economy and CO2 emissions in respect of the marketing of new passenger cars (OJ L 12, 18.1.2000, p. 16); (ii) Directive 2001/81/EC of the European Parliament and of the Council of 23 October 2001 on national emission ceilings for certain atmospheric pollutants (OJ L 309, 27.11.2001, p. 22); (iii) Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise (OJ L 189, 18.7.2002, p. 12); (iv) Regulation (EC) No 782/2003 of the European Parliament and of the Council of 14 April 2003 on the prohibition of organotin compounds on ships (OJ L 115, 9.5.2003, p. 1); (v) Directive 2004/35/EC of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage (OJ L 143, 30.4.2004, p. 56); (vi) Directive 2005/35/EC of the European Parliament and of the Council of 7 September 2005 on ship-source pollution and on the introduction of penalties for infringements (OJ L 255, 30.9.2005, p. 11); (vii) Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 January 2006 concerning the establishment of a European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC (OJ L 33, 4.2.2006, p. 1); (viii) Directive 2009/33/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of clean and energy-efficient road transport vehicles (OJ L 120, 15.5.2009, p. 5); (ix) Regulation (EC) No 443/2009 of the European Parliament and of the Council of 23 April 2009 setting emission performance standards for new passenger cars as part of the Community's integrated approach to reduce CO2 emissions from light-duty vehicles (OJ L 140, 5.6.2009, p. 1); (x) Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p. 1); (xi) Directive 2009/126/EC of the European Parliament and of the Council of 21 October 2009 on Stage II petrol vapour recovery during refuelling of motor vehicles at service stations (OJ L 285, 31.10.2009, p. 36); (xii) Regulation (EU) No 510/2011 of the European Parliament and of the Council of 11 May 2011 setting emission performance standards for new light commercial vehicles as part of the Union's integrated approach to reduce CO2 emissions from light-duty vehicles (OJ L 145, 31.5.2011, p. 1); (xiii) Directive 2014/94/EU of the European Parliament and of the Council of 22 October 2014 on the deployment of alternative fuels infrastructure (OJ L 307, 28.10.2014, p. 1); (xiv) Regulation (EU) 2015/757 of the European Parliament and of the Council of 29 April 2015 on the monitoring, reporting and verification of carbon dioxide emissions from maritime transport, and amending Directive 2009/16/EC (OJ L 123, 19.5.2015, p. 55); (xv) Directive (EU) 2015/2193 of the European Parliament and of the Council of 25 November 2015 on the limitation of emissions of certain pollutants into the air from medium combustion plants (OJ L 313, 28.11.2015, p. 1). 5. Rules on the protection and management of water and soil, as set out in: (i) Directive 2007/60/EC of the European Parliament and of the Council of 23 October 2007 on the assessment and management of flood risks (OJ L 288, 6.11.2007, p. 27); (ii) Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84); (iii) Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, p. 1). 6. Rules relating to the protection of nature and biodiversity, as set out in: (i) Council Regulation (EC) No 1936/2001 of 27 September 2001 laying down control measures applicable to fishing for certain stocks of highly migratory fish (OJ L 263, 3.10.2001, p. 1); (ii) Council Regulation (EC) No 812/2004 of 26 April 2004 laying down measures concerning bycatches of cetaceans in fisheries and amending Regulation (EC) No 88/98 (OJ L 150, 30.4.2004, p. 12); (iii) Regulation (EC) No 1007/2009 of the European Parliament and of the Council of 16 September 2009 on trade in seal products (OJ L 286, 31.10.2009, p. 36); (iv) Council Regulation (EC) No 734/2008 of 15 July 2008 on the protection of vulnerable marine ecosystems in the high seas from the adverse impacts of bottom fishing gears (OJ L 201, 30.7.2008, p. 8); (v) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7); (vi) Regulation (EU) No 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down the obligations of operators who place timber and timber products on the market (OJ L 295, 12.11.2010, p. 23); (vii) Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, p. 35). 7. Rules on chemicals, as set out in Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). 8. Rules relating to organic products, as set out in Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1). F. Point (a)(vi) of Article 2(1) — radiation protection and nuclear safety Rules on nuclear safety, as set out in: (i) Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations (OJ L 172, 2.7.2009, p. 18); (ii) Council Directive 2013/51/Euratom of 22 October 2013 laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption (OJ L 296, 7.11.2013, p. 12); (iii) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1); (iv) Council Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste (OJ L 199, 2.8.2011, p. 48); (v) Council Directive 2006/117/Euratom of 20 November 2006 on the supervision and control of shipments of radioactive waste and spent fuel (OJ L 337, 5.12.2006, p. 21); (vi) Council Regulation (Euratom) 2016/52 of 15 January 2016 laying down maximum permitted levels of radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency, and repealing Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 and (Euratom) No 770/90 (OJ L 13, 20.1.2016, p. 2); (vii) Council Regulation (Euratom) No 1493/93 of 8 June 1993 on shipments of radioactive substances between Member States (OJ L 148, 19.6.1993, p. 1). G. Point (a)(vii) of Article 2(1) — food and feed safety, animal health and animal welfare: 1. Union food and feed law governed by the general principles and requirements as defined by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). 2. Animal health, as regulated by: (i) Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1); (ii) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1). 3. Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1). 4. Rules and standards on the protection and well-being of animals, as set out in: (i) Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23); (ii) Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1); (iii) Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, p. 1); (iv) Council Directive 1999/22/EC of 29 March 1999 relating to the keeping of wild animals in zoos (OJ L 94, 9.4.1999, p. 24); (v) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33). H. Point (a) (viii) of Article 2(1) — public health: 1. Measures setting high standards of quality and safety of organs and substances of human origin, as regulated by: (i) Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30); (ii) Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48); (iii) Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14). 2. Measures setting high standards of quality and safety for medicinal products and devices of medical use, as regulated by: (i) Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1); (ii) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67); (iii) Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43); (iv) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1); (v) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1); (vi) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121); (vii) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1). 3. Patients' rights, as regulated by Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 4. Manufacture, presentation and sale of tobacco and related products, as regulated by Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1). I. Point (a)(ix) of Article 2(1) — consumer protection: Consumer rights and consumer protection, as regulated by: (i) Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers (OJ L 80, 18.3.1998, p. 27); (ii) Directive (EU) 2019/770 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the supply of digital content and digital services (OJ L 136, 22.5.2019, p. 1); (iii) Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC (OJ L 136, 22.5.2019, p. 28); (iv) Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees (OJ L 171, 7.7.1999, p. 12); (v) Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services and amending Council Directive 90/619/EEC and Directives 97/7/EC and 98/27/EC (OJ L 271, 9.10.2002, p. 16); (vi) Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (‘Unfair Commercial Practices Directive’) (OJ L 149, 11.6.2005, p. 22); (vii) Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC (OJ L 133, 22.5.2008, p. 66); (viii) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64); (ix) Directive 2014/92/EU of the European Parliament and of the Council of 23 July 2014 on the comparability of fees related to payment accounts, payment account switching and access to payment accounts with basic features (OJ L 257, 28.8.2014, p. 214). J. Point (a)(x) of Article 2(1) — protection of privacy and personal data, and security of network and information systems: (i) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37); (ii) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1); (iii) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1). Part II Article 3(1) refers to the following Union legislation: A. Point (a)(ii) of Article 2(1) — financial services, products and markets, and prevention of money laundering and terrorist financing: 1. Financial services: (i) Directive 2009/65/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS) (OJ L 302, 17.11.2009, p. 32); (ii) Directive (EU) 2016/2341 of the European Parliament and of the Council of 14 December 2016 on the activities and supervision of institutions for occupational retirement provision (IORPs) (OJ L 354, 23.12.2016, p. 37); (iii) Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directives 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ L 157, 9.6.2006, p. 87); (iv) Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC (OJ L 173, 12.6.2014, p. 1); (v) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338); (vi) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349); (vii) Regulation (EU) No 909/2014 of the European Parliament and of the Council of 23 July 2014 on improving securities settlement in the European Union and on central securities depositories and amending Directives 98/26/EC and 2014/65/EU and Regulation (EU) No 236/2012 (OJ L 257, 28.8.2014, p. 1); (viii) Regulation (EU) No 1286/2014 of the European Parliament and of the Council of 26 November 2014 on key information documents for packaged retail and insurance-based investment products (PRIIPs) (OJ L 352, 9.12.2014, p. 1); (ix) Regulation (EU) 2015/2365 of the European Parliament and of the Council of 25 November 2015 on transparency of securities financing transactions and of reuse and amending Regulation (EU) No 648/2012 (OJ L 337, 23.12.2015, p. 1); (x) Directive (EU) 2016/97 of the European Parliament and of the Council of 20 January 2016 on insurance distribution (OJ L 26, 2.2.2016, p. 19); (xi) Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC (OJ L 168, 30.6.2017, p. 12). 2. Prevention of money laundering and terrorist financing: (i) Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (OJ L 141, 5.6.2015, p. 73); (ii) Regulation (EU) 2015/847 of the European Parliament and of the Council of 20 May 2015 on information accompanying transfers of funds and repealing Regulation (EC) No 1781/2006 (OJ L 141, 5.6.2015, p. 1). B. Point (a)(iv) of Article 2(1) — transport safety: (i) Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18); (ii) Directive 2013/54/EU of the European Parliament and of the Council of 20 November 2013 concerning certain flag State responsibilities for compliance with and enforcement of the Maritime Labour Convention, 2006 (OJ L 329, 10.12.2013, p. 1); (iii) Directive 2009/16/EC of the European Parliament and of the Council of 23 April 2009 on port State control (OJ L 131, 28.5.2009, p. 57). C. Point (a)(v) of Article 2(1) — protection of the environment: (i) Directive 2013/30/EU of the European Parliament and of the Council of 12 June 2013 on safety of offshore oil and gas operations and amending Directive 2004/35/EC (OJ L 178, 28.6.2013, p. 66).

Protection of persons who report breaches of EU law Protection of persons who report breaches of EU law SUMMARY OF: Directive (EU) 2019/1937 on the protection of persons who report breaches of EU law WHAT IS THE AIM OF THE DIRECTIVE? It establishes rules and procedures to protect ‘whistleblowers’, individuals who report* information they acquired in a work-related context on breaches* of EU law in key policy areas. Breaches include both unlawful acts or omissions and abusive practices. KEY POINTS The directive covers reports on: breaches of rules in the following areas (listed in detail in Part I of the annex) public procurementfinancial services, products and markets; prevention of money laundering and terrorist financingproduct safety and compliancetransport safety in the railway, road, maritime and inland waters sectorsprotection of the environment, ranging from waste management to chemicalsradiation protection and nuclear safetyfood and feed safety, animal health and welfarepublic health, including patients’ rights and tobacco controlsconsumer protectionprotection of privacy and personal data, security and information systems; breaches affecting the EU’s financial interests; breaches relating to the internal market, including breaches of EU competition and State aid rules, and breaches of national corporate tax rules. The directive complements specific EU legislation which already includes rules on whistleblowing (notably on financial services, money laundering, terrorist financing, transport safety and environmental protection). The directive does not: affect the responsibility of EU governments to protect their national security; affect EU or national law on protection of classified information, legal and medical professional privilege, secrecy of judicial proceedings or criminal procedural rule; override national rules on rights of employees to consult their representatives or trade unions. The legislation covers a wide range of people working in the private and public sectors, including those who report after their work-based relationship has ended: employees, self-employed people, shareholders, persons belonging to the administrative, management and supervisory bodies of businesses, volunteers, trainees and job applicants; persons who help whistleblowers in a confidential manner, persons connected to a whistleblower who might suffer retaliation* at work, and legal entities linked to the whistleblower. Individuals are protected if they go public with their concerns provided they: first reported (internally and) externally but no action was taken; reasonably believe that there is an imminent or clear danger to the public interest, a risk of retaliation or little likelihood of their concern being properly addressed. Reporting arrangements include: internal channels: all private companies with 50 or more employees and, in principle, all public entities must set up effective reporting channels, ensuring confidentiality; public entities with less than 50 employees and municipalities with fewer than 10,000 inhabitants may be exempted; external channels: appropriate national authorities must establish reporting channels enabling confidential reporting; follow-up procedures and deadlines for handling reports received through internal and external channels. These include a duty not to reveal the whistleblower’s identity, except in strictly limited circumstancescompliance with EU data protection legislationrecords of every oral or written report received. Legal protection To qualify for legal protection, an individual must: have reasonable grounds to believe that the information they report is covered by the legislation and true at the time of reporting; report the breach to the competent authorities use the internal or external channels provided. Whistleblowers are encouraged to report internally (within the organisation) first, where the breach can be addressed effectively internally and where they consider that there is no risk of retaliation. However, they can choose whether to report first internally or to directly report externally to the competent authorities. Whistleblowers: are protected against all forms of retaliation, such as dismissal, demotion, intimidation and blacklisting; have access to appropriate support measures, notably independent information and advice and legal aid in accordance with EU rules on legal aid in criminal and cross-border civil proceedings; have access to appropriate remedial measures, such as interim relief and immunity from liability for breaching non-disclosure clauses in their contracts. EU countries must: ensure appropriate internal and external reporting channels are in place; take the necessary measures to prevent any retaliation against a whistleblower; respect the right to an effective remedy, a fair trial, presumption of innocence and rights of defence of persons concerned by the allegations in the reports; provide effective, proportionate and dissuasive penalties for breaches of certain rules of the directive, for instance for persons who hinder reporting or who retaliate against whistleblowers; transpose the directive and notify to the European Commission the transposition measures by 17 December 2021; with a possible exemption for transposing the provisions on the obligation of private companies with between 50 and 249 employees to set up their internal reporting channels until 17 December 2023; provide the Commission with annual data on numbers of reports received and investigations opened and their outcome, and the financial consequences. The Commission submits to the European Parliament and the Council: a first public and easily accessible report on the incorporation of the directive in EU countries’ national law by 17 December 2023; and a second on the implementation of the directive and on possible amendments needed, by 17 December 2025. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 16 December 2019 and It has to become law in the EU countries by 17 December 2021. BACKGROUND For more information, see: Whistleblower protection: Commission sets new, EU-wide rules (European Commission). KEY TERMS Report: oral or written communication informing of a breach. Breach: act or omission that is unlawful or defeats the aim of the EU legislation. Retaliation: any direct or indirect behaviour at work which could harm the whistleblower. MAIN DOCUMENT Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (OJ L 305, 26.11.2019, pp. 17-56) last update 20.05.2020

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28.12.2013 EN Official Journal of the European Union L 354/22 REGULATION (EU) No 1380/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) Council Regulation (EC) No 2371/2002 (4) established a Community system for the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (CFP). (2) The scope of the CFP includes the conservation of marine biological resources and the management of fisheries targeting them. In addition, it includes, in relation to market measures and financial measures in support of its objectives, fresh water biological resources and aquaculture activities, as well as the processing and marketing of fishery and aquaculture products, where such activities take place on the territory of Member States or in Union waters, including by fishing vessels flying the flag of, and registered in, third countries, by Union fishing vessels, or by nationals of Member States, without prejudice to the primary responsibility of the flag State, bearing in mind the provisions of Article 117 of the United Nations Convention on the Law of the Sea of 10 December 1982 (5) (UNCLOS). (3) Recreational fisheries can have a significant impact on fish resources and Member States should, therefore, ensure that they are conducted in a manner that is compatible with the objectives of the CFP. (4) The CFP should ensure that fishing and aquaculture activities contribute to long-term environmental, economic, and social sustainability. It should include rules that aim to ensure the traceability, security and quality of products marketed in the Union. Furthermore, the CFP should contribute to increased productivity, to a fair standard of living for the fisheries sector including small-scale fisheries, and to stable markets, and it should ensure the availability of food supplies and that they reach consumers at reasonable prices. The CFP should contribute to the Europe 2020 Strategy for smart, sustainable and inclusive growth, and should help to achieve the objectives set out therein. (5) The Union is a contracting party to UNCLOS (6) and, pursuant to Council Decision 98/414/EC (7), to the United Nations Agreement on the implementation of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the conservation and management of straddling fish stocks and highly migratory fish stocks of 4 December 1995 (8) (UN Fish Stocks Agreement) and, pursuant to Council Decision 96/428/EC (9), to the Agreement to promote compliance with international conservation and management measures by fishing vessels on the high seas of 24 November 1993 of the Food and Agriculture Organisation of the United Nations (10). (6) Those international instruments predominantly lay down conservation obligations, including obligations to take conservation and management measures designed to maintain or restore marine resources at levels which can produce the maximum sustainable yield both within sea areas under national jurisdiction and on the high seas, and to cooperate with other States to that end, obligations to apply the precautionary approach widely to conservation, management and exploitation of fish stocks, obligations to ensure compatibility of conservation and management measures where marine resources occur in sea areas of different jurisdictional status and obligations to have due regard to other legitimate uses of the seas. The CFP should, therefore, contribute to the Union's implementation of its international obligations under those international instruments. Where Member States adopt conservation and management measures, for which they have been empowered within the framework of the CFP, they should also act in a manner which is fully consistent with the international obligations regarding conservation and cooperation under those international instruments. (7) At the World Summit on Sustainable Development at Johannesburg in 2002, the Union and its Member States committed themselves to act against the continued decline of many fish stocks. Therefore, the Union should improve the CFP by adapting exploitation rates so as to ensure that, within a reasonable time-frame, the exploitation of marine biological resources restores and maintains populations of harvested stocks above levels that can produce the maximum sustainable yield. The exploitation rates should be achieved by 2015. Achieving those exploitation rates by a later date should be allowed only if achieving them by 2015 would seriously jeopardise the social and economic sustainability of the fishing fleets involved. After 2015, those rates should be achieved as soon as possible and in any event no later than 2020. Where scientific information is insufficient to determine those levels, approximative parameters may be considered. (8) Management decisions relating to maximum sustainable yield in mixed fisheries should take into account the difficulty of fishing all stocks in a mixed fishery at maximum sustainable yield at the same time, in particular where scientific advice indicates that it is very difficult to avoid the phenomenon of "choke species" by increasing the selectivity of the fishing gears used. Appropriate scientific bodies should be requested to provide advice on the appropriate fishing mortality levels in such circumstances. (9) The CFP should ensure coherence with the fisheries targets laid down in the Decision by the Conference of the Parties to the Convention on Biological Diversity on the Strategic Plan for Biodiversity 2011 – 2020, and with the biodiversity targets adopted by the European Council of 25 and 26 March 2010. (10) Sustainable exploitation of marine biological resources should be based on the precautionary approach, which derives from the precautionary principle referred to in the first subparagraph of Article 191(2) of the Treaty, taking into account available scientific data. (11) The CFP should contribute to the protection of the marine environment, to the sustainable management of all commercially exploited species, and in particular to the achievement of good environmental status by 2020, as set out in Article 1(1) of Directive 2008/56/EC of the European Parliament and of the Council (11). (12) The CFP should also contribute to the supplying of highly nutritional food to the Union market and to reducing the Union market's dependence on food imports. It should also foster direct and indirect job creation and economic development in coastal areas. (13) An ecosystem-based approach to fisheries management needs to be implemented, environmental impacts of fishing activities should be limited and unwanted catches should be avoided and reduced as far as possible. (14) It is important for the management of the CFP to be guided by principles of good governance. Those principles include decision-making based on best available scientific advice, broad stakeholder involvement and a long-term perspective. The successful management of the CFP also depends on a clear definition of responsibilities at Union, regional, national and local levels and on the mutual compatibility of the measures taken and their consistency with other Union policies. (15) The CFP should contribute to the improvement of safety and working conditions for fishing operators. (16) The CFP should pay full regard, where relevant, to animal health, animal welfare, food and feed safety. (17) Since all matters related to Europe's oceans and seas are interlinked, the CFP should be implemented in a way that is consistent with other Union policies and, in particular, that takes into account interactions with Union actions in other maritime policy areas. Coherence should be ensured in the management of different sectoral policies within the Baltic Sea, North Sea, Celtic seas, Bay of Biscay and the Iberian Coast, Mediterranean and Black Sea sea basins. (18) Union fishing vessels should have equal access to Union waters and resources subject to the rules of the CFP. (19) Existing rules restricting access to resources within the 12 nautical mile zones of Member States have operated satisfactorily, benefiting conservation by restricting fishing effort in the most sensitive part of Union waters. Those rules have also preserved the traditional fishing activities on which the social and economic development of certain coastal communities is highly dependent. Those rules should therefore continue to apply. Member States should endeavour to give preferential access for small-scale, artisanal or coastal fishermen. (20) Small offshore islands which are dependent on fishing should, where appropriate, be especially recognised and supported in order to enable them to survive and prosper. (21) Marine biological resources around the Union outermost regions referred to in the first paragraph of Article 349 of the Treaty should be especially protected since they contribute to the preservation of the local economy of those territories, having regard to their structural, social and economic situation. Certain fishing activities in those waters should therefore be limited to fishing vessels registered in the ports of those territories. (22) In order to contribute to the conservation of living aquatic resources and marine ecosystems, the Union should endeavour to protect areas that are biologically sensitive, by designating them as protected areas. In such areas, it should be possible to restrict or to prohibit fishing activities. When deciding which areas to designate, particular attention should be paid to those in which there is clear evidence of heavy concentrations of fish below minimum conservation reference size and of spawning grounds, and to areas which are deemed to be bio-geographically sensitive. Account should also be taken of existing conservation areas. In order to facilitate the designation process, Member States should identify suitable areas, including areas that form part of a coherent network, and, where appropriate, should cooperate with one another, preparing and sending joint recommendations to the Commission. In order to establish protected areas more effectively, it should be possible for the Commission to be empowered to establish them in a multiannual plan. In order to ensure a suitable level of democratic accountability and control, the Commission should regularly report to the European Parliament and to the Council on the functioning of those protected areas. (23) The objective of sustainable exploitation of marine biological resources is more effectively achieved through a multiannual approach to fisheries management, establishing as a priority multiannual plans reflecting the specificities of different fisheries. (24) Multiannual plans should, where possible, cover multiple stocks where those stocks are jointly exploited. The multiannual plans should establish the framework for the sustainable exploitation of stocks and marine ecosystems concerned, defining clear time-frames and safeguard mechanisms for unforeseen developments. Multiannual plans should also be governed by clearly defined management objectives in order to contribute to the sustainable exploitation of the stocks and to the protection of the marine ecosystems concerned. Those plans should be adopted in consultation with Advisory Councils, operators in the fishing industry, scientists and other stakeholders having an interest in fisheries management. (25) Directive 2009/147/EC of the European Parliament and of the Council (12), Council Directive 92/43/EEC (13) and Directive 2008/56/EC impose certain obligations on Member States as regards special protection areas, special areas of conservation and marine protected areas, respectively. Such measures might require the adoption of measures falling under the CFP. It is, therefore, appropriate to authorise Member States to adopt, in the waters under their sovereignty or jurisdiction, such conservation measures that are necessary to comply with their obligations under those Union acts where such measures do not affect the fisheries interests of other Member States. Where such measures might affect fisheries interests of other Member States, the power to adopt such measures should be granted to the Commission and recourse should be had to regional cooperation among the Member States concerned. (26) Measures are needed to reduce the current high levels of unwanted catches and to gradually eliminate discards. Unwanted catches and discards constitute a substantial waste and negatively affect the sustainable exploitation of marine biological resources and marine ecosystems and the financial viability of fisheries. An obligation to land all catches ("the landing obligation") of species which are subject to catch limits and, in the Mediterranean Sea, also catches of species which are subject to minimum sizes, made during fishing activities in Union waters or by Union fishing vessels should be established and gradually implemented and rules that have so far obliged fishermen to discard should be repealed. (27) The landing obligation should be introduced on a fishery-by-fishery basis. Fishermen should be allowed to continue discarding species which, according to the best available scientific advice, have a high survival rate when released into the sea. (28) In order to make the landing obligation workable and to mitigate the effect of varying yearly catch compositions, Member States should be allowed to transfer quotas between years, up to a certain percentage. (29) In the management of the landing obligation, it is necessary that Member States do their utmost to reduce unwanted catches. To this end, improvements of selective fishing techniques to avoid and reduce, as far as possible, unwanted catches must have high priority. It is important for Member States to distribute quotas between vessels in a mix that reflects as far as possible the expected composition of species in the fisheries. In the event of a mismatch between available quotas and actual fishing pattern, Member States should consider adjustments through quota swaps with other Member States, including on a permanent basis. Member States should also consider facilitating the pooling by vessel owners of individual quotas, for example at the level of producer organisations or groups of vessel owners. Ultimately, Member States should consider counting by-catch species against the quota of the target species, depending on the conservation status of the by-catch species. (30) The destination of landings of catches of fish under the minimum conservation reference size should be limited and should exclude sale for human consumption. (31) In order to cater for unwanted catches that are unavoidable even when all the measures for their reduction are applied, certain de minimis exemptions from the landing obligation should be established for the fisheries to which the landing obligation applies, primarily through multiannual plans. (32) Subject to scientific advice and without jeopardising the objectives of maximum sustainable yield or increasing fishing mortality, where the landing obligation, including the obligation to document catches, applies, an increase of related fishing opportunities should be possible, in order to take into account the fact that fish previously discarded will be landed. (33) Access to a fishery should be based on transparent and objective criteria including those of an environmental, social and economic nature. Member States should promote responsible fishing by providing incentives to those operators who fish in the least environmentally damaging way and who provide the greatest benefits for society. (34) For stocks for which no multiannual plan has been established, exploitation rates delivering maximum sustainable yield should be ensured by setting catch or fishing effort limits. If available data is insufficient, fisheries should be managed by using approximative parameters. (35) In view of the precarious economic state of the fishing industry and the dependence of certain coastal communities on fishing, it is necessary to ensure the relative stability of fishing activities by allocating fishing opportunities among Member States, based on a predictable share of the stocks for each Member State. (36) Such relative stability of fishing activities, given the temporary biological situation of stocks, should safeguard and take full account of the particular needs of regions where local communities are especially dependent on fisheries and related activities, as decided by the Council in its Resolution of 3 November 1976 (14), and in particular Annex VII thereto. (37) Therefore, it is in this sense that the concept of relative stability should be understood. (38) The Commission should be authorised to adopt temporary measures in the event of a serious threat, requiring immediate action, to the conservation of marine biological resources or to the marine ecosystem resulting from fishing activities. Those measures should be established within defined time-frames and should be operational for a fixed period of time. (39) Member States should cooperate at regional level in order to adopt joint recommendations and other instruments for the development and implementation of conservation measures and measures affecting fishing activity in areas protected by environmental law. In the framework of regional cooperation, the Commission should only adopt conservation measures through implementing acts or delegated acts where all Member States concerned in a region agree on a joint recommendation. In the absence of a joint recommendation, the Commission should submit a proposal for the relevant measures pursuant to the Treaty. (40) Member States should be empowered to adopt conservation and management measures for stocks in Union waters applicable solely to Union fishing vessels flying their flag. (41) In their 12 nautical mile zones, Member States should be empowered to adopt conservation and management measures applicable to all Union fishing vessels, provided that, where such measures apply to Union fishing vessels from other Member States, they are non-discriminatory, prior consultation of other Member States concerned has taken place and the Union has not adopted measures specifically addressing conservation and management within the 12 nautical mile zone concerned. (42) Member States should be able to introduce a system of transferable fishing concessions. (43) Member States should take specific measures to align the number of Union fishing vessels with available resources, based on their assessments of the balance between the fishing capacity of their fleets and the fishing opportunities available to them. The assessments should be made in accordance with Commission guidelines and be presented in an annual report to be transmitted to the Commission. Those reports should be made public. Each Member State should be able to choose the measures and instruments which it wishes to adopt in order to reduce excessive fishing capacity. (44) In addition, compulsory maximum fleet capacity ceilings and national entry/exit schemes in relation to decommissioning funding should be maintained for the purpose of managing and adjusting fishing capacity. (45) Member States should record the minimum information on characteristics and activities of Union fishing vessels flying their flag. Those records should be made available to the Commission for the purpose of monitoring the size of Member States' fleets. (46) Fisheries management based on the best available scientific advice requires harmonised, reliable and accurate data sets. Therefore, Member States should collect data on fleets and their fishing activities, in particular biological data on catches, including discards and survey information on fish stocks and on the potential environmental impact of fishing activities on the marine ecosystem. Member States should manage and make the collected data available to end-users and to other interested parties. Member States should cooperate with each other and with the Commission to coordinate data collection activities. Where relevant, Member States should also cooperate with third countries regarding data collection. Member States should provide the Commission, for its assessment, with an annual report on their data collection activities, which shall be made public. (47) Data collection should include data which facilitate the economic assessment of undertakings active in the fisheries sector, in aquaculture and in the processing of fisheries and aquaculture products and of employment trends in those industries. (48) The Scientific, Technical and Economic Committee for Fisheries (STECF), as established by Commission Decision 2005/629/EC (15), may be consulted on matters pertaining to the conservation and management of marine biological resources in order to ensure the required assistance of highly qualified scientific personnel, particularly in the application of biological, economic, environmental, social and technical disciplines. (49) Policy-oriented fisheries science should be reinforced by means of nationally-adopted fisheries scientific data collection, research and innovation programmes implemented in coordination with other Member States and within Union research and innovation frameworks. Better cooperation between industry and scientists should also be fostered. (50) The Union should promote the objectives of the CFP internationally, ensuring that Union fishing activities outside Union waters are based on the same principles and standards as those applicable under Union law, and promoting a level–playing field for Union operators and third-country operators. To this end, the Union should seek to lead the process of strengthening the performance of regional and international organisations in order to better enable them to conserve and manage marine living resources under their purview, including combating illegal, unreported and unregulated (IUU) fishing. The Union should cooperate with third countries and international organisations for the purpose of improving compliance with international measures, including combating IUU. The position of the Union should be based on the best available scientific advice. (51) Sustainable fisheries partnership agreements with third countries should ensure that Union fishing activities in third country waters are based on the best available scientific advice and relevant information exchange, ensuring a sustainable exploitation of the marine biological resources, transparency as regards the determination of the surplus and, consequently, a management of the resources that is consistent with the objectives of the CFP. Those agreements, which provide for access to resources commensurate with the interests of the Union fleet in exchange for a financial contribution from the Union, should contribute to the establishment of a high quality governance framework to ensure, in particular, efficient data collection, monitoring, control and surveillance measures. (52) Respect for democratic principles and human rights, as laid down in the Universal Declaration of Human Rights and other relevant international human rights instruments, and for the principle of the rule of law, should constitute an essential element of sustainable fisheries partnership agreements, which should contain a specific human rights clause. The introduction of a human rights clause in sustainable fisheries partnership agreements should be fully consistent with the overall Union development policy objectives. (53) Aquaculture should contribute to the preservation of the food production potential on a sustainable basis throughout the Union so as to guarantee long-term food security, including food supplies, as well as growth and employment for Union citizens, and to contribute to meeting the growing world demand for aquatic food. (54) The Commission's Strategy for the Sustainable Development of European Aquaculture adopted in 2009, which was welcomed and endorsed by the Council and welcomed by the European Parliament, noted the need for the creation and promotion of a level-playing field for aquaculture as the basis for its sustainable development. (55) Aquaculture activities in the Union are influenced by different conditions across national borders, including as regards authorisations for the operators. Therefore, Union strategic guidelines for national strategic plans should be developed to improve the competitiveness of the aquaculture industry, supporting its development and innovation, and encouraging economic activity, diversification and improving the quality of life in coastal and inland areas. Furthermore, mechanisms should be introduced for the exchange between Member States of information and best practices through an open method of coordination of national measures concerning business security, access to Union waters and space, and the simplification of licensing procedures. (56) The specific nature of aquaculture requires an Advisory Council for stakeholder consultation on elements of Union policies which could affect aquaculture. (57) There is a need to strengthen the competitiveness of the Union fishery and aquaculture sector, and for simplification in support of better management of its production and marketing activities. The common market organisation for fishery and aquaculture products should ensure a level-playing field for all fishery and aquaculture products marketed in the Union regardless of their origin, should enable consumers to make better informed choices and support responsible consumption, and should improve the economic knowledge and understanding of the Union markets along the supply chain. (58) The common market organisation should be implemented in compliance with international commitments of the Union, in particular with regard to the provisions of the World Trade Organisation. (59) In order to ensure compliance with the rules of the CFP, an effective system of control, inspection and enforcement should be established, that includes the fight against IUU fishing activities. (60) The use of modern and effective technologies should be promoted in the framework of the Union system for control, inspection, and enforcement. Member States and the Commission should have the possibility to conduct pilot projects on new control technologies and data management systems. (61) In order to ensure that the conditions in different Member States for the application of control and enforcement rules are comparable, cooperation between Member States on identifying effective, proportionate and dissuasive penalties should be encouraged. (62) In order to ensure the involvement of operators in the Union data collection and in the Union system for control, inspection, and enforcement, Member States should be able to require their operators to contribute proportionally to the corresponding operational costs. (63) The objectives of the CFP cannot be sufficiently achieved by Member States alone, given the problems encountered in the development of the fishing industry and its management, and the limits on the financial resources of the Member States. Therefore, to contribute to the achievement of those objectives, multiannual Union financial assistance should be granted that is focused on the priorities of the CFP and tailored to the specific features of the fishing industry in individual Member States. (64) Union financial assistance should be made conditional upon compliance by Member States and operators, including vessel owners, with the rules of the CFP. Subject to specific rules to be adopted, Union financial assistance should be interrupted, suspended or corrected in cases of non-compliance with a specific obligation of the CFP by a Member State or a serious infringement of those rules by an operator. (65) Dialogue with stakeholders has proven to be essential for achieving the objectives of the CFP. Taking into account the diverse conditions throughout Union waters and the increased regionalisation of the CFP, Advisory Councils should enable the CFP to benefit from the knowledge and experience of all stakeholders. (66) In view of the special characteristics of the outermost regions, of aquaculture, of markets and of the Black Sea, it is appropriate to establish a new Advisory Council for each of them. (67) The power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of the adoption of conservation measures accompanying certain environmental obligations by Member States, the adapting of the landing obligation for the purpose of complying with the Union's international obligations, the extension of the landing obligation to other species using the regionalisation process, the adoption of specific discard plans using the regionalisation process, the adoption of de minimis exemptions to the landing obligation if no other implementation measure for that obligation has been adopted, and the establishment of detailed rules for the functioning of Advisory Councils. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (68) In order to ensure uniform conditions for the implementation of the provisions of this Regulation in respect of temporary measures to alleviate a serious threat to the conservation of marine biological resources, of the entry-exit scheme in fleet management and of the recording, format and transmission of data for the Union fishing fleet register, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (16). (69) In accordance with the principle of proportionality, as set out in Article 5 of the Treaty on European Union, this Regulation does not go beyond what is necessary to achieve its objectives. (70) Council Decision 2004/585/EC (17) should be repealed upon entry in force of the corresponding rules pursuant to this Regulation. (71) By reason of the number and importance of the amendments to be made, Regulation (EC) No 2371/2002 should be repealed, HAVE ADOPTED THIS REGULATION: PART I GENERAL PROVISIONS Article 1 Scope 1. The Common Fisheries Policy (CFP) shall cover: (a) the conservation of marine biological resources and the management of fisheries and fleets exploiting such resources; (b) in relation to measures on markets and financial measures in support of the implementation of the CFP: fresh water biological resources, aquaculture, and the processing and marketing of fisheries and aquaculture products. 2. The CFP shall cover the activities referred to in paragraph 1 where they are carried out: (a) on the territory of Member States to which the Treaty applies; (b) in Union waters, including by fishing vessels flying the flag of, and registered in, third countries; (c) by Union fishing vessels outside Union waters; or (d) by nationals of Member States, without prejudice to the primary responsibility of the flag State. Article 2 Objectives 1. The CFP shall ensure that fishing and aquaculture activities are environmentally sustainable in the long-term and are managed in a way that is consistent with the objectives of achieving economic, social and employment benefits, and of contributing to the availability of food supplies. 2. The CFP shall apply the precautionary approach to fisheries management, and shall aim to ensure that exploitation of living marine biological resources restores and maintains populations of harvested species above levels which can produce the maximum sustainable yield. In order to reach the objective of progressively restoring and maintaining populations of fish stocks above biomass levels capable of producing maximum sustainable yield, the maximum sustainable yield exploitation rate shall be achieved by 2015 where possible and, on a progressive, incremental basis at the latest by 2020 for all stocks. 3. The CFP shall implement the ecosystem-based approach to fisheries management so as to ensure that negative impacts of fishing activities on the marine ecosystem are minimised, and shall endeavour to ensure that aquaculture and fisheries activities avoid the degradation of the marine environment. 4. The CFP shall contribute to the collection of scientific data. 5. The CFP shall, in particular: (a) gradually eliminate discards, on a case-by-case basis, taking into account the best available scientific advice, by avoiding and reducing, as far as possible, unwanted catches, and by gradually ensuring that catches are landed; (b) where necessary, make the best use of unwanted catches, without creating a market for such of those catches that are below the minimum conservation reference size; (c) provide conditions for economically viable and competitive fishing capture and processing industry and land-based fishing related activity; (d) provide for measures to adjust the fishing capacity of the fleets to levels of fishing opportunities consistent with paragraph 2, with a view to having economically viable fleets without overexploiting marine biological resources; (e) promote the development of sustainable Union aquaculture activities to contribute to food supplies and security and employment; (f) contribute to a fair standard of living for those who depend on fishing activities, bearing in mind coastal fisheries and socio-economic aspects; (g) contribute to an efficient and transparent internal market for fisheries and aquaculture products and contribute to ensuring a level–playing field for fisheries and aquaculture products marketed in the Union; (h) take into account the interests of both consumers and producers; (i) promote coastal fishing activities, taking into account socio-economic aspects; (j) be coherent with the Union environmental legislation, in particular with the objective of achieving a good environmental status by 2020 as set out in Article 1(1) of Directive 2008/56/EC, as well as with other Union policies. Article 3 Principles of good governance The CFP shall be guided by the following principles of good governance: (a) the clear definition of responsibilities at the Union, regional, national and local levels; (b) the taking into account of regional specificities, through a regionalised approach; (c) the establishment of measures in accordance with the best available scientific advice; (d) a long-term perspective; (e) administrative cost efficiency; (f) appropriate involvement of stakeholders, in particular Advisory Councils, at all stages - from conception to implementation of the measures; (g) the primary responsibility of the flag State; (h) consistency with other Union policies; (i) the use of impact assessments as appropriate; (j) coherence between the internal and external dimension of the CFP; (k) transparency of data handling in accordance with existing legal requirements, with due respect for private life, the protection of personal data and confidentiality rules; availability of data to the appropriate scientific bodies, other bodies with a scientific or management interest, and other defined end-users. Article 4 Definitions 1. For the purpose of this Regulation the following definitions shall apply: (1) 'Union waters' means the waters under the sovereignty or jurisdiction of the Member States, with the exception of the waters adjacent to the territories listed in Annex II to the Treaty; (2) 'marine biological resources' means available and accessible living marine aquatic species, including anadromous and catadromous species during their marine life; (3) 'fresh water biological resources' means available and accessible living fresh water aquatic species; (4) 'fishing vessel' means any vessel equipped for commercial exploitation of marine biological resources or a blue fin tuna trap; (5) 'Union fishing vessel' means a fishing vessel flying the flag of a Member State and registered in the Union; (6) 'entry to the fishing fleet' means registration of a fishing vessel in the fishing vessel register of a Member State; (7) 'maximum sustainable yield' means the highest theoretical equilibrium yield that can be continuously taken on average from a stock under existing average environmental conditions without significantly affecting the reproduction process; (8) 'precautionary approach to fisheries management', as referred to in Article 6 of the UN Fish Stocks Agreement, means an approach according to which the absence of adequate scientific information should not justify postponing or failing to take management measures to conserve target species, associated or dependent species and non-target species and their environment; (9) 'ecosystem-based approach to fisheries management' means an integrated approach to managing fisheries within ecologically meaningful boundaries which seeks to manage the use of natural resources, taking account of fishing and other human activities, while preserving both the biological wealth and the biological processes necessary to safeguard the composition, structure and functioning of the habitats of the ecosystem affected, by taking into account the knowledge and uncertainties regarding biotic, abiotic and human components of ecosystems; (10) 'discards' means catches that are returned to the sea; (11) 'low impact fishing' means utilising selective fishing techniques which have a low detrimental impact on marine ecosystems or which may result in low fuel emissions, or both; (12) 'selective fishing' means fishing with fishing methods or fishing gears that target and capture organisms by size or species during the fishing operation, allowing non-target specimens to be avoided or released unharmed; (13) 'fishing mortality rate' means the rate at which biomass or individuals are removed from a stock by means of fishery activities over a given period; (14) 'stock' means a marine biological resource that occurs in a given management area; (15) 'catch limit' means, as appropriate, either a quantitative limit on catches of a fish stock or group of fish stocks over a given period where such fish stocks or group of fish stocks are subject to an obligation to land, or a quantitative limit on landings of a fish stock or group of fish stocks over a given period for which the obligation to land does not apply; (16) 'conservation reference point' means values of fish stock population parameters (such as biomass or fishing mortality rate) used in fisheries management, for example in respect of an acceptable level of biological risk or a desired level of yield; (17) 'minimum conservation reference size' means the size of a living marine aquatic species taking into account maturity, as established by Union law, below which restrictions or incentives apply that aim to avoid capture through fishing activity; such size replaces, where relevant, the minimum landing size; (18) 'stock within safe biological limits' means a stock with a high probability that its estimated spawning biomass at the end of the previous year is higher than the limit biomass reference point (Blim) and its estimated fishing mortality rate for the previous year is less than the limit fishing mortality rate reference point (Flim); (19) 'safeguard' means a precautionary measure designed to avoid something undesirable occurring; (20) 'technical measure' means a measure that regulates the composition of catches by species and size and the impacts on components of the ecosystems resulting from fishing activities by establishing conditions for the use and structure of fishing gear and restrictions on access to fishing areas; (21) 'fishing effort' means the product of the capacity and the activity of a fishing vessel; for a group of fishing vessels it is the sum of the fishing effort of all vessels in the group; (22) 'Member State having a direct management interest' means a Member State which has an interest consisting of either fishing opportunities or a fishery taking place in the exclusive economic zone of the Member State concerned, or, in the Mediterranean Sea, a traditional fishery on the high seas; (23) 'transferable fishing concession' means a revocable user entitlement to a specific part of fishing opportunities allocated to a Member State or established in a management plan adopted by a Member State in accordance with Article 19 of Council Regulation (EC) No 1967/2006 (18), which the holder may transfer; (24) 'fishing capacity' means a vessel's tonnage in GT (Gross Tonnage) and its power in kW (Kilowatt) as defined in Articles 4 and 5 of Council Regulation (EEC) No 2930/86 (19); (25) 'aquaculture' means the rearing or cultivation of aquatic organisms using techniques designed to increase the production of the organisms in question beyond the natural capacity of the environment, where the organisms remain the property of a natural or legal person throughout the rearing and culture stage, up to and including harvesting; (26) 'fishing licence' means a licence as defined in point (9) of Article 4 of Council Regulation (EC) No 1224/2009 (20); (27) 'fishing authorisation' means an authorisation as defined in point (10) of Article 4 of Regulation (EC) No 1224/2009; (28) 'fishing activity' means searching for fish, shooting, setting, towing, hauling of a fishing gear, taking catch on board, transhipping, retaining on board, processing on board, transferring, caging, fattening and landing of fish and fishery products; (29) 'fishery products' means aquatic organisms resulting from any fishing activity or products derived therefrom; (30) 'operator' means the natural or legal person who operates or holds any undertaking carrying out any of the activities related to any stage of production, processing, marketing, distribution and retail chains of fisheries and aquaculture products; (31) 'serious infringement' means an infringement that is defined as such in relevant Union law, including in Article 42(1) of Council Regulation (EC) No 1005/2008 (21) and in Article 90(1) of Regulation (EC) No 1224/2009; (32) 'end-user of scientific data' means a body with a research or management interest in the scientific analysis of data in the fisheries sector; (33) 'surplus of allowable catch' means that part of the allowable catch which a coastal State does not harvest, resulting in an overall exploitation rate for individual stocks that remains below levels at which stocks are capable of restoring themselves and maintaining populations of harvested species above desired levels based on the best available scientific advice; (34) 'aquaculture products' means aquatic organisms at any stage of their life cycle resulting from any aquaculture activity or products derived therefrom; (35) 'spawning stock biomass' means an estimate of the mass of the fish of a particular stock that reproduces at a defined time, including both males and females and fish that reproduce viviparously; (36) 'mixed fisheries' means fisheries in which more than one species is present and where different species are likely to be caught in the same fishing operation; (37) 'sustainable fisheries partnership agreement' means an international agreement concluded with a third state for the purpose of obtaining access to waters and resources in order to sustainably exploit a share of the surplus of marine biological resources, in exchange for financial compensation from the Union, which may include sectoral support. 2. For the purposes of this Regulation, the following geographical definitions of geographical areas shall apply: (a) 'North Sea' means ICES zones (22) IIIa and IV; (b) 'Baltic Sea' means ICES zones IIIb, IIIc and IIId; (c) 'North Western waters' means ICES zones V (excluding Va and only Union waters of Vb), VI and VII; (d) 'South Western waters' means ICES zones VIII, IX and X (waters around Azores), and CECAF zones (23) 34.1.1, 34.1.2 and 34.2.0 (waters around Madeira and the Canary Islands); (e) 'Mediterranean Sea' means Maritime Waters of the Mediterranean to the East of line 5°36′ West; (f) 'Black Sea' means the GFCM (General Fisheries Commission for the Mediterranean) geographical sub-area as defined in Resolution GFCM/33/2009/2. PART II ACCESS TO WATERS Article 5 General rules on access to waters 1. Union fishing vessels shall have equal access to waters and resources in all Union waters other than those referred to in paragraphs 2 and 3, subject to the measures adopted under Part III. 2. In the waters up to 12 nautical miles from baselines under their sovereignty or jurisdiction, Member States shall be authorised, until 31 December 2022, to restrict fishing to fishing vessels that traditionally fish in those waters from ports on the adjacent coast, without prejudice to the arrangements for Union fishing vessels flying the flag of other Member States under existing neighbourhood relations between Member States and the arrangements contained in Annex I, fixing for each Member State the geographical zones within the coastal bands of other Member States where fishing activities are pursued and the species concerned. Member States shall inform the Commission of the restrictions put in place under this paragraph. 3. In the waters up to 100 nautical miles from the baselines of the Union outermost regions referred to in the first paragraph of Article 349 of the Treaty, the Member States concerned shall be authorised, until 31 December 2022, to restrict fishing to vessels registered in the ports of those territories. Such restrictions shall not apply to Union vessels that traditionally fish in those waters, in so far as those vessels do not exceed the fishing effort traditionally exerted. Member States shall inform the Commission of the restrictions put in place under this paragraph. 4. The measures which are to apply after the expiry of the arrangements set out in paragraphs 2 and 3 shall be adopted by 31 December 2022. PART III MEASURES FOR THE CONSERVATION AND SUSTAINABLE EXPLOITATION OF MARINE BIOLOGICAL RESOURCES TITLE I Conservation measures Article 6 General provisions 1. For the purpose of achieving the objectives of the CFP in respect of the conservation and sustainable exploitation of marine biological resources as set out in Article 2, the Union shall adopt conservation measures as set out in Article 7. 2. When applying this Regulation, the Commission shall consult the relevant advisory bodies and the relevant scientific bodies. Conservation measures shall be adopted taking into account available scientific, technical and economic advice, including, where relevant, reports drawn up by STECF and other advisory bodies, advice received from Advisory Councils and joint recommendations made by Member States pursuant to Article 18. 3. Member States may cooperate with one another for the purpose of adopting measures pursuant to Articles 11, 15 and 18. 4. Member States shall coordinate with one another before adopting national measures pursuant to Article 20(2). 5. In specific cases, in particular as regards the Mediterranean region, Member States may be empowered to adopt legally binding acts in the area of the CFP, including conservation measures. Article 18 shall apply, where appropriate. Article 7 Types of conservation measures 1. Measures for the conservation and sustainable exploitation of marine biological resources may include, inter alia, the following: (a) multiannual plans under Articles 9 and 10; (b) targets for the conservation and sustainable exploitation of stocks and related measures to minimise the impact of fishing on the marine environment; (c) measures to adapt the fishing capacity of fishing vessels to available fishing opportunities; (d) incentives, including those of an economic nature, such as fishing opportunities, to promote fishing methods that contribute to more selective fishing, to the avoidance and reduction, as far as possible, of unwanted catches, and to fishing with low impact on the marine ecosystem and fishery resources; (e) measures on the fixing and allocation of fishing opportunities; (f) measures to achieve the objectives of Article 15; (g) minimum conservation reference sizes; (h) pilot projects on alternative types of fishing management techniques and on gears that increase selectivity or that minimise the negative impact of fishing activities on the marine environment; (i) measures necessary for compliance with obligations under Union environmental legislation adopted pursuant to Article 11; (j) technical measures as referred to in paragraph 2. 2. Technical measures may include, inter alia, the following: (a) characteristics of fishing gears and rules concerning their use; (b) specifications on the construction of fishing gear, including: (i) modifications or additional devices to improve selectivity or to minimise the negative impact on the ecosystem; (ii) modifications or additional devices to reduce the incidental capture of endangered, threatened and protected species, as well as to reduce other unwanted catches; (c) limitations or prohibitions on the use of certain fishing gears, and on fishing activities, in certain areas or periods; (d) requirements for fishing vessels to cease operating in a defined area for a defined minimum period in order to protect temporary aggregations of endangered species, spawning fish, fish below minimum conservation reference size, and other vulnerable marine resources; (e) specific measures to minimise the negative impact of fishing activities on marine biodiversity and marine ecosystems, including measures to avoid and reduce, as far as possible, unwanted catches. Article 8 Establishment of fish stock recovery areas 1. The Union shall, while taking due account of existing conservation areas, endeavour to establish protected areas due to their biological sensitivity, including areas where there is clear evidence of heavy concentrations of fish below minimum conservation reference size and of spawning grounds. In such areas fishing activities may be restricted or prohibited in order to contribute to the conservation of living aquatic resources and marine ecosystems. The Union shall continue to give additional protection to existing biologically sensitive areas. 2. For those purposes, Member States shall identify, where possible, suitable areas which may form part of a coherent network and shall prepare, where appropriate, joint recommendations in accordance with Article 18(7) with a view to the Commission submitting a proposal in accordance with the Treaty. 3. The Commission may be empowered in a multiannual plan to establish such biologically sensitive protected areas. Article 18(1) to (6) shall apply. The Commission shall report regularly to the European Parliament and to the Council on protected areas. TITLE II Specific measures Article 9 Principles and objectives of multiannual plans 1. Multiannual plans shall be adopted as a priority, based on scientific, technical and economic advice, and shall contain conservation measures to restore and maintain fish stocks above levels capable of producing maximum sustainable yield in accordance with Article 2(2). 2. Where targets relating to the maximum sustainable yield as referred to in Article 2(2) cannot be determined, owing to insufficient data, the multiannual plans shall provide for measures based on the precautionary approach, ensuring at least a comparable degree of conservation of the relevant stocks. 3. Multiannual plans shall cover either: (a) single species; or (b) in the case of mixed fisheries or where the dynamics of stocks relate to one another, fisheries exploiting several stocks in a relevant geographical area, taking into account knowledge about the interactions between fish stocks, fisheries and marine ecosystems. 4. The measures to be included in multiannual plans, and the calendar for implementing them, shall be proportionate to the objectives and targets pursued and to the time-frame envisaged. Before measures are included in the multiannual plans, account shall be taken of their likely economic and social impact. 5. Multiannual plans may contain specific conservation objectives and measures based on the ecosystem approach in order to address the specific problems of mixed fisheries in relation to the achievement of the objectives set out in Article 2(2) for the mixture of stocks covered by the plan in cases where scientific advice indicates that increases in selectivity cannot be achieved. Where necessary, the multiannual plan shall include specific alternative conservation measures, based on the ecosystem approach, for some of the stocks that it covers. Article 10 Content of multiannual plans 1. As appropriate and without prejudice to the respective competences under the Treaty, a multiannual plan shall include: (a) the scope, in terms of stocks, fishery and the area to which the multiannual plan shall be applied; (b) objectives that are consistent with the objectives set out in Article 2 and with the relevant provisions of Articles 6 and 9; (c) quantifiable targets such as fishing mortality rates and/or spawning stock biomass; (d) clear time-frames to reach the quantifiable targets; (e) conservation reference points consistent with the objectives set out in Article 2; (f) objectives for conservation and technical measures to be taken in order to achieve the targets set out in Article 15, and measures designed to avoid and reduce, as far as possible, unwanted catches; (g) safeguards to ensure that quantifiable targets are met, as well as remedial action, where needed, including for situations where the deteriorating quality of data or non-availability put the sustainability of the stock at risk. 2. A multiannual plan may also include: (a) other conservation measures, in particular measures to gradually eliminate discards, taking into account the best available scientific advice, or to minimise the negative impact of fishing on the ecosystem, to be further specified, where appropriate, in accordance with Article 18; (b) quantifiable indicators for periodic monitoring and assessment of progress in achieving the targets of the multiannual plan; (c) where appropriate, specific objectives for the freshwater part of the life cycle of anadromous and catadromous species. 3. A multiannual plan shall provide for its revision after an initial ex-post evaluation, in particular to take account of changes in scientific advice. Article 11 Conservation measures necessary for compliance with obligations under Union environmental legislation 1. Member States are empowered to adopt conservation measures not affecting fishing vessels of other Member States that are applicable to waters under their sovereignty or jurisdiction and that are necessary for the purpose of complying with their obligations under Article 13(4) of Directive 2008/56/EC, Article 4 of Directive 2009/147/EC or Article 6 of Directive 92/43/EEC, provided that those measures are compatible with the objectives set out in Article 2 of this Regulation, meet the objectives of the relevant Union legislation that they intend to implement, and are at least as stringent as measures under Union law. 2. Where a Member State ("the initiating Member State") considers that measures need to be adopted for the purpose of complying with the obligations referred to in paragraph 1 and other Member States have a direct management interest in the fishery to be affected by such measures, the Commission shall be empowered to adopt such measures, upon request, by means of delegated acts in accordance with Article 46. For this purpose, Article 18(1) to (4) and (6) shall apply mutatis mutandis. 3. The initiating Member State shall provide the Commission and the other Member States having a direct management interest with relevant information on the measures required, including their rationale, scientific evidence in support and details on their practical implementation and enforcement. The initiating Member State and the other Member States having a direct management interest may submit a joint recommendation, as referred to in Article 18(1), within six months from the provision of sufficient information. The Commission shall adopt the measures, taking into account any available scientific advice, within three months from receipt of a complete request. If not all Member States succeed in agreeing on a joint recommendation to be submitted to the Commission in accordance with the first subparagraph within the deadline set therein, or if the joint recommendation is deemed not to be compatible with the requirements referred to in paragraph 1, the Commission may submit a proposal in accordance with the Treaty. 4. By way of derogation from paragraph 3, in the absence of a joint recommendation referred to in paragraph 3, in cases of urgency, the Commission shall adopt the measures. The measures to be adopted in a case of urgency shall be limited to those in the absence of which the achievement of the objectives associated with the establishment of the conservation measures in accordance with the Directives referred to in paragraph 1 and the Member State's intentions, is in jeopardy. 5. The measures referred to in paragraph 4 shall apply for a maximum period of 12 months which may be extended for a maximum period of 12 months where the conditions provided for in that paragraph continue to exist. 6. The Commission shall facilitate cooperation between the Member State concerned and the other Member States having a direct management interest in the fishery in the process of implementation and enforcement of the measures adopted under paragraphs 2, 3 and 4. Article 12 Commission measures in case of a serious threat to marine biological resources 1. On duly justified imperative grounds of urgency relating to a serious threat to the conservation of marine biological resources or to the marine ecosystem based on evidence, the Commission, at the reasoned request of a Member State or on its own initiative, may, in order to alleviate that threat, adopt immediately applicable implementing acts applicable for a maximum period of six months in accordance with the procedure referred to in Article 47(3). 2. The Member State shall communicate the request referred to in paragraph 1 simultaneously to the Commission, to other Member States and to the Advisory Councils concerned. The other Member States and the Advisory Councils may submit their written comments within seven working days of the receipt of the notification. The Commission shall take a decision within 15 working days of the receipt of the request referred to in paragraph 1. 3. Before expiry of the initial period of application of immediately applicable implementing acts referred to in paragraph 1, the Commission may, where the conditions under paragraph 1 are complied with, adopt immediately applicable implementing acts extending the application of such emergency measure for a maximum period of six months with immediate effect. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 47(3). Article 13 Member State emergency measures 1. On the basis of evidence of a serious threat to the conservation of marine biological resources or to the marine ecosystem relating to fishing activities in waters falling under the sovereignty or jurisdiction of a Member State that require immediate action, that Member State may adopt emergency measures to alleviate the threat. Such measures shall be compatible with the objectives set out in Article 2 and no less stringent than those provided for in Union law. Such measures shall apply for a maximum period of three months. 2. Where emergency measures to be adopted by a Member State are liable to affect fishing vessels of other Member States, such measures shall be adopted only after consulting the Commission, the relevant Member States and the relevant Advisory Councils on a draft of the measures accompanied by an explanatory memorandum. The consulting Member State may set a reasonable deadline for the consultation which shall, however, not be shorter than one month. 3. Where the Commission considers that a measure adopted under this Article does not comply with the conditions set out in paragraph 1, it may, subject to providing relevant reasons, request that the Member State concerned amend or repeal that measure. Article 14 Avoidance and minimisation of unwanted catches 1. In order to facilitate the introduction of the obligation to land all catches in the respective fishery in accordance with Article 15 ("the landing obligation"), Member States may conduct pilot projects, based on the best available scientific advice and taking into account the opinions of the relevant Advisory Councils, with the aim of fully exploring all practicable methods for the avoidance, minimisation and elimination of unwanted catches in a fishery. 2. Member States may produce a "discard atlas" showing the level of discards in each of the fisheries which are covered by Article 15(1). Article 15 Landing obligation 1. All catches of species which are subject to catch limits and, in the Mediterranean, also catches of species which are subject to minimum sizes as defined in Annex III to Regulation (EC) No 1967/2006, caught during fishing activities in Union waters or by Union fishing vessels outside Union waters in waters not subject to third countries' sovereignty or jurisdiction, in the fisheries and geographical areas listed below shall be brought and retained on board the fishing vessels, recorded, landed and counted against the quotas where applicable, except when used as live bait, in accordance with the following time-frames: (a) From 1 January 2015 at the latest: — small pelagic fisheries (i.e. fisheries for mackerel, herring, horse mackerel, blue whiting, boarfish, anchovy, argentine, sardine, sprat); — large pelagic fisheries (i.e. fisheries for bluefin tuna, swordfish, albacore tuna, bigeye tuna, blue and white marlin); — fisheries for industrial purposes (inter alia, fisheries for capelin, sandeel and Norwegian pout); — fisheries for salmon in the Baltic Sea. (b) From 1 January 2015 at the latest for species which define the fisheries and from 1 January 2017 at the latest for all other species in fisheries in Union waters of the Baltic Sea for species subject to catch limits other than those covered by point (a). (c) From 1 January 2016 at the latest for the species which define the fisheries and from 1 January 2019 at the latest for all other species in: (i) the North Sea — fisheries for cod, haddock, whiting, saithe; — fisheries for Norway lobster; — fisheries for common sole and plaice; — fisheries for hake; — fisheries for Northern prawn; (ii) North Western waters — fisheries for cod, haddock, whiting, saithe; — fisheries for Norway lobster; — fisheries for common sole and plaice; — fisheries for hake; (iii) South Western waters — fisheries for Norway lobster; — fisheries for common sole and plaice; — fisheries for hake; (iv) other fisheries for species subject to catch limits. (d) From 1 January 2017 at the latest for species which define the fisheries and from 1 January 2019 at the latest for all other species in fisheries not covered by point (a) in the Mediterranean, in the Black Sea and in all other Union waters and in non-Union waters not subject to third countries' sovereignty or jurisdiction. 2. Paragraph 1 shall be without prejudice to the Union's international obligations. The Commission shall be empowered to adopt delegated acts, in accordance with Article 46, for the purpose of implementing such international obligations into Union law, including, in particular, derogations from the landing obligation under this Article. 3. Where all the Member States having a direct management interest in a particular fishery agree that the landing obligation should apply to species other than those listed in paragraph 1, they may submit a joint recommendation for the purpose of extending the application of the landing obligation to such other species. For this purpose, Article 18(1) to (6) shall apply mutatis mutandis. Where such a joint recommendation is submitted, the Commission shall be empowered to adopt delegated acts, in accordance with Article 46, containing such measures. 4. The landing obligation referred to in paragraph 1 shall not apply to: (a) species in respect of which fishing is prohibited and which are identified as such in a Union legal act adopted in the area of the CFP; (b) species for which scientific evidence demonstrates high survival rates, taking into account the characteristics of the gear, of the fishing practices and of the ecosystem; (c) catches falling under de minimis exemptions. 5. Details of the implementation of the landing obligation referred to in paragraph 1 shall be specified in multiannual plans referred to in Articles 9 and 10 and, where relevant, further specified in accordance with Article 18, including: (a) specific provisions regarding fisheries or species covered by the landing obligation referred to in paragraph 1; (b) the specification of exemptions to the landing obligation of species referred to in point (b) of paragraph 4; (c) provisions for de minimis exemptions of up to 5 % of total annual catches of all species subject to the landing obligation referred to in paragraph 1. The de minimis exemption shall apply in the following cases: (i) where scientific evidence indicates that increases in selectivity are very difficult to achieve; or (ii) to avoid disproportionate costs of handling unwanted catches, for those fishing gears where unwanted catches per fishing gear do not represent more than a certain percentage, to be established in a plan, of total annual catch of that gear. Catches under the provisions referred to in this point shall not be counted against the relevant quotas; however, all such catches shall be fully recorded. For a transitional period of four years, the percentage of the total annual catches referred to in this point shall increase: (i) by two percentage points in the first two years of application of the landing obligation; and (ii) by one percentage point in the subsequent two years; (d) provisions on documentation of catches; (e) where appropriate, the fixing of minimum conservation reference sizes in accordance with paragraph 10. 6. Where no multiannual plan, or no management plan in accordance with Article 18 of Regulation (EC) No 1967/2006, is adopted for the fishery in question, the Commission shall be empowered to adopt, in accordance with Article 18 of this Regulation, delegated acts in accordance with Article 46 of this Regulation, laying down on a temporary basis and for a period of no more than three years a specific discard plan containing the specifications referred to in points (a) to (e) of paragraph 5 of this Article. Member States may cooperate, in accordance with Article 18 of this Regulation, in the drawing up of such a plan with a view to the Commission adopting such acts or submitting a proposal in accordance with the ordinary legislative procedure. 7. Where no measures have been adopted for the purpose of specifying the de minimis exemption either in a multiannual plan in accordance with paragraph 5 or in a specific discard plan in accordance with paragraph 6, the Commission shall adopt delegated acts, in accordance with Article 46, setting the de minimis exemption referred to in point (c) of paragraph 4 which shall, subject to the conditions set out in point (c)(i) or (ii) of paragraph 5, amount to no more than 5 % of total annual catches of all species to which the landing obligation applies under paragraph 1. That de minimis exemption shall be adopted so as to apply from the date of application of the relevant landing obligation. 8. By way of derogation from the obligation to count catches against the relevant quotas in accordance with paragraph 1, catches of species that are subject to the landing obligation and that are caught in excess of quotas of the stocks in question, or catches of species in respect of which the Member State has no quota, may be deducted from the quota of the target species provided that they do not exceed 9 % of the quota of the target species. This provision shall only apply where the stock of the non-target species is within safe biological limits. 9. For stocks subject to the landing obligation, Member States may use a year-to-year flexibility of up to 10 % of their permitted landings. For this purpose, a Member State may allow landing of additional quantities of the stock that is subject to the landing obligation provided that such quantities do not exceed 10 % of the quota allocated to that Member State. Article 105 of Regulation (EC) No 1224/2009 shall apply. 10. Minimum conservation reference sizes may be established with the aim of ensuring the protection of juveniles of marine organisms. 11. For the species subject to the landing obligation as specified in paragraph 1, the use of catches of species below the minimum conservation reference size shall be restricted to purposes other than direct human consumption, including fish meal, fish oil, pet food, food additives, pharmaceuticals and cosmetics. 12. For species that are not subject to the landing obligation as specified in paragraph 1, the catches of species below the minimum conservation reference size shall not be retained on board, but shall be returned immediately to the sea. 13. For the purpose of monitoring compliance with the landing obligation, Member States shall ensure detailed and accurate documentation of all fishing trips and adequate capacity and means, such as observers, closed-circuit television (CCTV) and others. In doing so, Member States shall respect the principle of efficiency and proportionality. Article 16 Fishing opportunities 1. Fishing opportunities allocated to Member States shall ensure relative stability of fishing activities of each Member State for each fish stock or fishery. The interests of each Member State shall be taken into account when new fishing opportunities are allocated. 2. When the landing obligation in respect of a fish stock is introduced, fishing opportunities shall be fixed taking into account the change from fixing fishing opportunities that reflect landings to fixing fishing opportunities that reflect catches, on the basis of the fact that, for the first and subsequent years, discarding of that stock will no longer be allowed. 3. Where new scientific evidence shows that there is a significant disparity between the fishing opportunities that have been fixed for a specific stock and the actual state of that stock, Member States having a direct management interest may submit a reasoned request to the Commission for it to submit a proposal to alleviate that disparity, while respecting the objectives set out in Article 2(2). 4. Fishing opportunities shall be fixed in accordance with the objectives set out in Article 2(2) and shall comply with quantifiable targets, time-frames and margins established in accordance with Article 9(2) and points (b) and (c) of Article 10(1). 5. Measures on the fixing and allocation of fishing opportunities available to third countries in Union waters shall be established in accordance with the Treaty. 6. Each Member State shall decide how the fishing opportunities that are allocated to it, and which are not subject to a system of transferable fishing concessions, may be allocated to vessels flying its flag (e.g. by creating individual fishing opportunities). It shall inform the Commission of the allocation method. 7. For the allocation of fishing opportunities pertaining to mixed fisheries, Member States shall take account of the likely catch composition of vessels participating in such fisheries. 8. Member States may, after notifying the Commission, exchange all or part of the fishing opportunities allocated to them. Article 17 Criteria for the allocation of fishing opportunities by Member States When allocating the fishing opportunities available to them, as referred to in Article 16, Member States shall use transparent and objective criteria including those of an environmental, social and economic nature. The criteria to be used may include, inter alia, the impact of fishing on the environment, the history of compliance, the contribution to the local economy and historic catch levels. Within the fishing opportunities allocated to them, Member States shall endeavour to provide incentives to fishing vessels deploying selective fishing gear or using fishing techniques with reduced environmental impact, such as reduced energy consumption or habitat damage. TITLE III Regionalisation Article 18 Regional cooperation on conservation measures 1. Where the Commission has been granted powers, including in a multiannual plan established pursuant to Articles 9 and 10, as well as in cases provided for in Articles 11 and 15(6), to adopt measures by means of delegated or implementing acts in respect of a Union conservation measure applying to a relevant geographical area, Member States having a direct management interest affected by those measures may, within a deadline to be stipulated in the relevant conservation measure and/or multiannual plan, agree to submit joint recommendations for achieving the objectives of the relevant Union conservation measures, the multiannual plans or the specific discard plans. The Commission shall not adopt any such delegated or implementing acts before the expiry of the deadline for submission of joint recommendations by the Member States. 2. For the purpose of paragraph 1, Member States having a direct management interest affected by the measures referred to in paragraph 1 shall cooperate with one another in formulating joint recommendations. They shall also consult the relevant Advisory Councils. The Commission shall facilitate the cooperation between Member States, including, where necessary, by ensuring that a scientific contribution is obtained from the relevant scientific bodies. 3. Where a joint recommendation is submitted under paragraph 1, the Commission may adopt those measures by means of delegated or implementing acts, provided that such recommendation is compatible with the relevant conservation measure and/or multiannual plan. 4. Where the conservation measure applies to a specific fish stock shared with third countries and managed by multilateral fisheries organisations or under bilateral or multilateral agreements, the Union shall endeavour to agree with the relevant partners the measures that are necessary to achieve the objectives set out in Article 2. 5. Member States shall ensure that the joint recommendations on conservation measures to be adopted pursuant to paragraph 1 are based on the best available scientific advice and fulfil all of the following requirements: (a) they are compatible with the objectives set out in Article 2; (b) they are compatible with the scope and objectives of the relevant conservation measure; (c) they are compatible with the scope and meet the objectives and quantifiable targets set out in a relevant multiannual plan effectively; (d) they are at least as stringent as measures under Union law. 6. If all Member States do not succeed in agreeing on joint recommendations to be submitted to the Commission in accordance with paragraph 1 within a set deadline or if the joint recommendations on conservation measures are deemed not to be compatible with the objectives and quantifiable targets of the conservation measures in question, the Commission may submit a proposal for appropriate measures in accordance with the Treaty. 7. In addition to the cases referred to in paragraph 1, Member States having a direct management interest in a fishery in a defined geographical area may also make joint recommendations to the Commission on measures to be proposed or adopted by the Commission. 8. As a supplementary or alternative method of regional cooperation, Member States will be empowered, in a Union conservation measure that applies to a relevant geographical area, including in a multiannual plan established pursuant to Articles 9 and 10, to adopt within a set deadline measures further specifying that conservation measure. The Member States concerned shall closely cooperate in the adoption of such measures. Paragraphs 2, 4 and 5 of this Article shall apply mutatis mutandis. The Commission shall be associated and its comments shall be taken into account. Member States shall only adopt their respective national measures if an agreement on the content of those measures has been reached by all the Member States concerned. Where the Commission considers that a Member State's measure does not comply with the conditions set out in the relevant conservation measure, it may, subject to providing relevant reasons, request that the Member State concerned amend or repeal that measure. TITLE IV National measures Article 19 Member State measures applicable to fishing vessels flying their flag or to persons established in their territory 1. A Member State may adopt measures for the conservation of fish stocks in Union waters provided that those measures fulfil all of the following requirements: (a) they apply solely to fishing vessels flying the flag of that Member State or, in the case of fishing activities which are not conducted by a fishing vessel, to persons established in that part of its territory to which the Treaty applies; (b) they are compatible with the objectives set out in Article 2; (c) they are at least as stringent as measures under Union law. 2. A Member State shall, for control purposes, inform the other Member States concerned of provisions adopted pursuant to paragraph 1. 3. Member States shall make publicly available appropriate information concerning the measures adopted in accordance with this Article. Article 20 Member State measures within the 12 nautical mile zone 1. A Member State may take non-discriminatory measures for the conservation and management of fish stocks and the maintenance or improvement of the conservation status of marine ecosystems within 12 nautical miles of its baselines provided that the Union has not adopted measures addressing conservation and management specifically for that area or specifically addressing the problem identified by the Member State concerned. The Member State measures shall be compatible with the objectives set out in Article 2 and shall be at least as stringent as measures under Union law. 2. Where conservation and management measures to be adopted by a Member State are liable to affect fishing vessels of other Member States, such measures shall be adopted only after consulting the Commission, the relevant Member States and the relevant Advisory Councils on a draft of the measures, which shall be accompanied by an explanatory memorandum that demonstrates, inter alia, that those measures are non-discriminatory. For the purpose of such consultation, the consulting Member State may set a reasonable deadline, which shall, however, not be shorter than two months. 3. Member States shall make publicly available appropriate information concerning the measures adopted in accordance with this Article. 4. Where the Commission considers that a measure adopted under this Article does not comply with the conditions set out in paragraph 1, it may, subject to providing relevant reasons, request that the Member State concerned amends or repeals the relevant measure. PART IV MANAGEMENT OF FISHING CAPACITY Article 21 Establishment of systems of transferable fishing concessions Member States may establish a system of transferable fishing concessions. Member States having such a system shall establish and maintain a register of transferable fishing concessions. Article 22 Adjustment and management of fishing capacity 1. Member States shall put in place measures to adjust the fishing capacity of their fleet to their fishing opportunities over time, taking into account trends and based on best scientific advice, with the objective of achieving a stable and enduring balance between them. 2. In order to achieve the objective referred to in paragraph 1, Member States shall send to the Commission, by 31 May each year, a report on the balance between the fishing capacity of their fleets and their fishing opportunities. To facilitate a common approach across the Union, that report shall be prepared in accordance with common guidelines which may be developed by the Commission indicating the relevant technical, social and economic parameters. The report shall contain the annual capacity assessment of the national fleet and of all fleet segments of the Member State. The report shall seek to identify structural overcapacity by segment and shall estimate the long-term profitability by segment. The reports shall be made publicly available. 3. With regard to the assessment referred to in the second subparagraph of paragraph 2, Member States shall base their analysis on the balance between the fishing capacity of their fleets and their fishing opportunities. Separate assessments shall be drawn up for fleets operating in the outermost regions and for vessels operating exclusively outside Union waters. 4. If the assessment clearly demonstrates that the fishing capacity is not effectively balanced with fishing opportunities, the Member State shall prepare and include in its report an action plan for the fleet segments with identified structural overcapacity. The action plan shall set out the adjustment targets and tools to achieve a balance and a clear time-frame for its implementation. On a yearly basis, the Commission shall prepare a report for the European Parliament and for the Council on the balance between the fishing capacity of the Member States' fleets and their fishing opportunities, in accordance with the guidelines referred to in the first subparagraph of paragraph 2. The report shall include action plans referred to in the first subparagraph of this paragraph. The first report shall be submitted by 31 March 2015. Failure to make the report referred to in paragraph 2, and/or failure to implement the action plan referred to in the first subparagraph of this paragraph, may result in a proportionate suspension or interruption of relevant Union financial assistance to that Member State for fleet investment in the fleet segment or segments concerned in accordance with a future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the period 2014–2020. 5. No exit from the fleet supported by public aid shall be permitted unless preceded by the withdrawal of the fishing licence and the fishing authorisations. 6. The fishing capacity corresponding to the fishing vessels withdrawn with public aid shall not be replaced. 7. Member States shall ensure that from 1 January 2014 the fishing capacity of their fleets does not exceed at any time the fishing capacity ceilings set out in Annex II. Article 23 Entry/Exit scheme 1. Member States shall manage entries into their fleets and exits from their fleets in such a way that the entry into the fleet of new capacity without public aid is compensated for by the prior withdrawal of capacity without public aid of at least the same amount. 2. The Commission may adopt implementing acts laying down implementing rules for the application of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(2). 3. No later than 30 December 2018, the Commission shall evaluate the Entry/Exit scheme in the light of the evolving relationship between fleet capacity and prospected fishing opportunities, and propose, where appropriate, an amendment to that scheme. Article 24 Fishing fleet registers 1. Member States shall record the information on ownership, on vessel and gear characteristics and on the activity of Union fishing vessels flying their flag that is necessary for the management of measures established under this Regulation. 2. Member States shall submit to the Commission the information referred to in paragraph 1. 3. The Commission shall maintain a Union fishing fleet register containing the information that it receives pursuant paragraph 2. It shall provide public access to the Union fishing fleet register, while ensuring that personal data is adequately protected. 4. The Commission shall adopt implementing acts, establishing technical operational requirements for the recording, format and transmission modalities of the information referred to in paragraphs 1, 2 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(2). PART V SCIENTIFIC BASE FOR FISHERIES MANAGEMENT Article 25 Data requirements for fisheries management 1. Member States shall, in accordance with the rules adopted in the area of data collection, collect biological, environmental, technical, and socio-economic data necessary for fisheries management, manage those data and make them available to end–users, including bodies designated by the Commission. The acquisition and management of such data shall be eligible for funding through the European Maritime and Fisheries Fund in accordance with a future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the period 2014–2020. Those data shall, in particular, enable the assessment of: (a) the state of exploited marine biological resources; (b) the level of fishing and the impact that fishing activities have on the marine biological resources and on the marine ecosystems; and (c) the socio-economic performance of the fisheries, aquaculture and processing sectors within and outside Union waters. 2. The collection, management and use of data shall be based on the following principles: (a) accuracy and reliability, and collection in a timely manner; (b) the use of coordination mechanisms with a view to avoiding duplication of data collection for different purposes; (c) safe storage and protection of collected data in computerised databases, and their public availability where appropriate, including at aggregated level, whilst ensuring confidentiality; (d) access by the Commission, or by bodies designated by it, to the national databases and systems used for processing the collected data for the purpose of verification of the existence and quality of the data; (e) the availability in a timely manner of the relevant data and the respective methodologies by which they are obtained, for bodies with a research or management interest in the scientific analysis of data in the fisheries sector and for any interested parties, save in circumstances where protection and confidentiality are required under applicable Union law. 3. Every year, Member States shall submit to the Commission a report on the execution of their national data collection programmes and shall make it publicly available. The Commission shall assess the annual report on data collection after consulting its scientific advisory body and, where appropriate, regional fisheries management organisations (RFMOs) to which the Union is a contracting party or observer and relevant international scientific bodies. 4. Member States shall ensure the national coordination of the collection and management of scientific data for fisheries management, including socio-economic data. To this end, they shall designate a national correspondent and organise an annual national coordination meeting. The Commission shall be informed of the national coordination activities and shall be invited to the coordination meetings. 5. In close cooperation with the Commission, Member States shall coordinate their data collection activities with other Member States in the same region, and shall make every effort to coordinate their actions with third countries having sovereignty or jurisdiction over waters in the same region. 6. The collection, management and use of data shall be carried out in a cost-effective manner. 7. Failure by a Member State to collect and/or to provide data in a timely manner to end-users may result in a proportionate suspension or interruption of relevant Union financial assistance to that Member State, in accordance with a future Union legal act establishing the conditions for the financial support for maritime and fisheries policy for the period 2014–2020. Article 26 Consulting scientific bodies The Commission shall consult appropriate scientific bodies. STECF shall be consulted, where appropriate, on matters pertaining to the conservation and management of living marine resources, including biological, economic, environmental, social and technical considerations. Consultations of scientific bodies shall take into account the proper management of public funds, with the aim of avoiding duplication of work by such bodies. Article 27 Research and Scientific Advice 1. Member States shall carry out fisheries and aquaculture research and innovation programmes. They shall coordinate their fisheries research innovation and scientific advice programmes with other Member States, in close cooperation with the Commission, in the context of the Union research and innovation frameworks, involving, where appropriate, the relevant Advisory Councils. Those activities shall be eligible for funding through the Union budget in accordance with the relevant Union legal acts. 2. Member states shall, with the involvement of the relevant stakeholders, utilising inter alia available Union financial resources and coordinating with one another, ensure availability of relevant competences and human resources to be involved in the scientific advisory process. PART VI EXTERNAL POLICY Article 28 Objectives 1. In order to ensure sustainable exploitation, management and conservation of marine biological resources and the marine environment, the Union shall conduct its external fisheries relations in accordance with its international obligations and policy objectives, as well as the objectives and principles set out in Articles 2 and 3. 2. In particular, the Union shall: (a) actively support and contribute to the development of scientific knowledge and advice; (b) improve policy coherence of Union initiatives, with particular regard to environmental, trade and development activities and strengthen consistency of actions taken in the context of development cooperation and scientific, technical and economic cooperation; (c) contribute to sustainable fishing activities that are economically viable and promote employment within the Union; (d) ensure that Union fishing activities outside Union waters are based on the same principles and standards as those applicable under Union law in the area of the CFP, while promoting a level–playing field for Union operators vis-à-vis third-country operators; (e) promote and support, in all international spheres, action necessary to eradicate IUU-fishing; (f) promote the establishment and the strengthening of compliance committees of RFMOs, periodical independent performance reviews and appropriate remedial actions, including effective and dissuasive penalties, which are to be applied in a transparent and non-discriminatory manner. 3. The provisions of this Part shall be without prejudice to specific provisions adopted under Article 218 of the Treaty. TITLE I International fisheries organisations Article 29 Union activities in international fisheries organisations 1. The Union shall actively support and contribute to the activities of international organisations dealing with fisheries, including RFMOs. 2. The positions of the Union in international organisations dealing with fisheries and in RFMOs shall be based on the best available scientific advice so as to ensure that fishery resources are managed in accordance with the objectives laid down in Article 2, in particular paragraph 2 and point (c) of paragraph 5 thereof. The Union shall seek to lead the process of strengthening the performance of RFMOs so as to better enable them to conserve and manage marine living resources under their purview. 3. The Union shall actively support the development of appropriate and transparent mechanisms for the allocation of fishing opportunities. 4. The Union shall foster cooperation among RFMOs and consistency between their respective regulatory frameworks, and shall support the development of scientific knowledge and advice to ensure that their recommendations are based on such scientific advice. Article 30 Compliance with international provisions The Union shall, including through the European Fisheries Control Agency ("the Agency"), cooperate with third countries and international organisations dealing with fisheries, including RFMOs, to strengthen compliance with measures, especially those to combat IUU fishing, in order to ensure that measures adopted by such international organisations are strictly adhered to. TITLE II Sustainable fisheries partnership agreements Article 31 Principles and objectives of Sustainable fisheries partnership agreements 1. Sustainable fisheries partnership agreements with third countries shall establish a legal, environmental, economic and social governance framework for fishing activities carried out by Union fishing vessels in third country waters. Such frameworks may include: (a) development and support for the necessary scientific and research institutions; (b) monitoring, control and surveillance capabilities; (c) other capacity building elements concerning the development of a sustainable fisheries policy of the third country. 2. For the purpose of ensuring the sustainable exploitation of surpluses of marine biological resources, the Union shall endeavour to ensure that the Sustainable fisheries partnership agreements with third countries are of mutual benefit to the Union and to the third country concerned, including its local population and fishing industry and that they contribute to continuing the activity of Union fleets and seek to obtain an appropriate share of the available surplus, commensurate with the Union fleets' interest. 3. For the purpose of ensuring that Union vessels fishing under Sustainable fisheries partnership agreements operate, where appropriate, under similar standards to those applicable to Union fishing vessels fishing in Union waters, the Union shall endeavour to include in Sustainable fisheries partnership agreements appropriate provisions on obligations to land fish and fishery products. 4. Union fishing vessels shall only catch surplus of the allowable catch as referred to in Article 62(2) and (3) of the UNCLOS, and identified, in a clear and transparent manner, on the basis of the best available scientific advice and of the relevant information exchanged between the Union and the third country about the total fishing effort on the affected stocks by all fleets. Concerning straddling or highly migratory fish stocks, the determination of the resources available for access should take due account of scientific assessments conducted at the regional level as well as conservation and management measures adopted by relevant RFMOs. 5. Union fishing vessels shall not operate in the waters of the third country with which a Sustainable fisheries partnership agreement is in force unless they are in possession of a fishing authorisation which has been issued in accordance with that agreement. 6. The Union shall ensure that Sustainable fisheries partnership agreements include a clause concerning respect for democratic principles and human rights, which constitutes an essential element of such agreements. Those agreements shall also, to the extent possible, include: (a) a clause prohibiting the granting of more favourable conditions to other fleets fishing in those waters than those granted to Union economic actors, including conditions concerning the conservation, development and management of resources, financial arrangements, and fees and rights relating to the issuing of fishing authorisations; (b) an exclusivity clause relating to the rule provided for in paragraph 5. 7. Efforts shall be made at Union level to monitor the activities of Union fishing vessels that operate in non–Union waters outside the framework of Sustainable fisheries partnership agreements. 8. Member States shall ensure that Union fishing vessels flying their flag and operating outside Union waters are in a position to provide detailed and accurate documentation of all fishing and processing activities. 9. A fishing authorisation, as referred to in paragraph 5, shall be granted to a vessel which has left the Union fishing fleet register and which has subsequently returned to it within 24 months, only if the owner of that vessel has provided to the competent authorities of the flag Member State all data required to establish that, during that period, the vessel was operating in a manner fully consistent with the standards applicable to a vessel flagged in the Union. Where the state granting the flag during the period that the vessel was off the Union fishing fleet register became recognised under Union law as a non-cooperating state with regard to combating, deterring and eliminating IUU fishing, or as a state allowing for non-sustainable exploitation of living marine resources, such fishing authorisation shall only be granted if it is established that the vessel's fishing operations ceased and the owner took immediate action to remove the vessel from the register of that state. 10. The Commission shall arrange for independent ex-ante and ex-post evaluations of each protocol to a Sustainable fisheries partnership agreement, and make them available to the European Parliament and to the Council in good time before it submits to the Council a recommendation to authorise the opening of negotiations for a successor protocol. A summary of such evaluations shall be made publicly available. Article 32 Financial assistance 1. The Union shall provide financial assistance to third countries through Sustainable fisheries partnership agreements in order to: (a) support part of the cost of access to the fisheries resources in third country waters; the part of the cost of access to the fisheries resources to be paid by Union vessel owners shall be assessed for each Sustainable fisheries partnership agreement or a Protocol to it and shall be fair, non-discriminatory and commensurate with the benefits provided through the access conditions; (b) establish the governance framework, including the development and maintenance of the necessary scientific and research institutions, promote consultation processes with interest groups, and monitoring, control and surveillance capability and other capacity building items relating to the development of a sustainable fisheries policy driven by the third country. Such financial assistance shall be conditional upon the achievement of specific results and complementary to and consistent with the development projects and programmes implemented in the third country in question. 2. Under each Sustainable fisheries partnership agreement, the financial assistance for sectoral support shall be decoupled from payments for access to fisheries resources. The Union shall require the achievement of specific results as a condition for payments under the financial assistance, and shall closely monitor progress. TITLE III Management of stocks of common interest Article 33 Principles and objectives of management of stocks of common interest to the Union and third countries and agreements on exchange and joint management 1. Where stocks of common interest are also exploited by third countries, the Union shall engage with those third countries with a view to ensuring that those stocks are managed in a sustainable manner that is consistent with this Regulation, and in particular with the objective laid down in Article 2(2). Where no formal agreement is reached, the Union shall make every effort to reach common arrangements for fishing of such stocks with a view to making the sustainable management possible, in particular, concerning the objective in Article 2(2), thereby promoting a level–playing field for Union operators. 2. In order to ensure a sustainable exploitation of stocks shared with third countries and to guarantee stability of the fishing operations of its fleets, the Union shall, in accordance with UNCLOS, endeavour to establish bilateral or multilateral agreements with third countries for the joint management of stocks, including the establishment, where appropriate, of access to waters and resources and conditions for such access, the harmonisation of conservation measures and the exchange of fishing opportunities. PART VII AQUACULTURE Article 34 Promoting sustainable aquaculture 1. With a view to promoting sustainability and contributing to food security and supplies, growth and employment, the Commission shall establish non-binding Union strategic guidelines on common priorities and targets for the development of sustainable aquaculture activities. Such strategic guidelines shall take account of the relative starting positions and different circumstances throughout the Union and shall form the basis for multiannual national strategic plans, and shall aim at: (a) improving the competitiveness of the aquaculture industry and supporting its development and innovation; (b) reducing the administrative burden and making the implementation of Union law more efficient and responsive to the needs of stakeholders; (c) encouraging economic activity; (d) diversification and improvement of the quality of life in coastal and inland areas; (e) integrating aquaculture activities into maritime, coastal and inland spatial planning. 2. By 30 June 2014, Member States shall establish a multiannual national strategic plan for the development of aquaculture activities on their territory. 3. The multiannual national strategic plan shall include the Member State's objectives and the measures and the timetables necessary to achieve them. 4. Multiannual national strategic plans shall, in particular, have the following aims: (a) administrative simplification, in particular regarding evaluations and impact studies and licenses; (b) reasonable certainty for aquaculture operators in relation to access to waters and space; (c) indicators for environmental, economic and social sustainability; (d) assessment of other possible cross-border effects, especially on marine biological resources and marine ecosystems in neighbouring Member States; (e) the creation of synergies between national research programmes and collaboration between the industry and the scientific community; (f) the promotion of the competitive advantage of sustainable, high quality food; (g) the promotion of aquaculture practices and research with a view to enhancing positive effects on the environment and on the fish resources, and to reducing negative impacts, including reducing pressure on fish stocks used for feed production, and increasing resource efficiency. 5. Member States shall exchange information and best practices through an open method of coordination of the national measures contained in multiannual national strategic plans. 6. The Commission shall encourage the exchange of information and best practices among Member States and shall facilitate the coordination of national measures foreseen in the multiannual national strategic plan. PART VIII COMMON MARKET ORGANISATION Article 35 Objectives 1. A common organisation of the markets in fishery and aquaculture products (the common market organisation) shall be established to: (a) contribute to the achievement of the objectives set out in Article 2, and in particular to the sustainable exploitation of living marine biological resources; (b) enable the fishery and aquaculture industry to apply the CFP at the appropriate level; (c) strengthen the competitiveness of the Union fishery and aquaculture industry, in particular producers; (d) improve the transparency and stability of the markets, in particular as regards economic knowledge and understanding of the Union markets for fishery and aquaculture products along the supply chain, ensure that the distribution of added value along the sector's supply chain is more balanced, improve consumer information and raise awareness, by means of notification and labelling that provides comprehensible information; (e) contribute to ensuring a level–playing field for all products marketed in the Union by promoting sustainable exploitation of fisheries resources; (f) contribute to ensuring that consumers have a diverse supply of fishery and aquaculture products; (g) provide the consumer with verifiable and accurate information regarding the origin of the product and its mode of production, in particular through marking and labelling. 2. The common market organisation shall apply to the fishery and aquaculture products listed in Annex I to Regulation (EU) No 1379/2013 of the European Parliament and of the Council (24), which are marketed in the Union. 3. The common market organisation shall include, in particular: (a) the organisation of the industry including market stabilization measures; (b) the production and marketing plans of fishery and aquaculture producer organisations; (c) common marketing standards; (d) consumer information. PART IX CONTROL AND ENFORCEMENT Article 36 Objectives 1. Compliance with the CFP rules shall be ensured through an effective Union fisheries control system, including the fight against IUU fishing. 2. Control and enforcement of the CFP shall in particular be based on and shall include the following: (a) a global, integrated and common approach; (b) cooperation and coordination between Member States, the Commission and the Agency; (c) cost-efficiency and proportionality; (d) the use of efficient control technologies for the availability and quality of data on fisheries; (e) a Union framework for control, inspection and enforcement; (f) a risk-based strategy focused on systematic and automated cross-checks of all available relevant data; (g) the development of a culture of compliance and co-operation among all operators and fishermen. The Union shall adopt appropriate measures with regard to third countries which allow non-sustainable fishing. 3. Member States shall adopt appropriate measures for ensuring control, inspection and enforcement of activities carried out within the scope of the CFP, including the establishment of effective, proportionate and dissuasive penalties. Article 37 Expert group on compliance 1. An expert group on compliance shall be established by the Commission to assess, facilitate and strengthen the implementation of, and compliance with, the obligations under the Union fisheries control system. 2. The expert group on compliance shall be composed of representatives of the Commission and the Member States. At the request of the European Parliament, the Commission may invite the European Parliament to send experts to attend meetings of the expert group. The Agency may assist the expert group on compliance meetings as an observer. 3. The expert group shall in particular: (a) regularly review issues of compliance and implementation under Union fisheries control system and identify possible difficulties of common interest in implementation of the CFP rules; (b) formulate advice in relation to the implementation of the CFP rules, including prioritisation of Union financial assistance; and (c) exchange information on control and inspection activities, including the fight against IUU fishing. 4. The European Parliament and the Council shall be kept fully informed on a regular basis by the expert group on compliance activities referred to in paragraph 3. Article 38 Pilot projects on new control technologies and data management systems The Commission and the Member States may carry out pilot projects on new control technologies and systems for data management. Article 39 Contribution to control, inspection, enforcement and data collection costs Member States may require their operators to contribute proportionally to the operational costs of implementing the Union fisheries control system and of data collection. PART X FINANCIAL INSTRUMENTS Article 40 Objectives Union financial assistance may be granted to contribute to the achievement of the objectives set out in Article 2. Article 41 Conditions for financial assistance to Member States 1. Subject to the conditions to be specified in the applicable Union legal acts, Union financial assistance to Member States shall be conditional upon compliance with the CFP rules by Member States. 2. Non–compliance by Member States with the CFP rules may result in the interruption or suspension of payments or in the application of a financial correction to Union financial assistance under the CFP. Such measures shall be proportionate to the nature, gravity, duration and repetition of the non–compliance. Article 42 Conditions for financial assistance to operators 1. Subject to the conditions to be specified in the applicable Union legal acts, Union financial assistance to operators shall be conditional upon compliance with the CFP rules by operators. 2. Subject to specific rules to be adopted, serious infringements by operators of the CFP rules shall result in temporary or permanent bans on access to the Union financial assistance and/or the application of financial reductions. Such measures, taken by the Member State, shall be dissuasive, effective and proportionate to the nature, gravity, duration and repetition of serious infringements. 3. Member States shall ensure that Union financial assistance is granted only if no penalties for serious infringements have been imposed on the operator concerned within a period of one year prior to the date of application for Union financial assistance. PART XI ADVISORY COUNCILS Article 43 Establishment of Advisory Councils 1. Advisory Councils shall be established for each of the geographical areas or fields of competence set out in Annex III, in order to promote a balanced representation of all stakeholders in accordance with Article 45(1) and to contribute to the achievement of the objectives set out in Article 2. 2. In particular, the following new Advisory Councils shall be established, in accordance with Annex III: (a) an Advisory Council for the outermost regions, divided into three sections for each of the following sea basins: West Atlantic, East Atlantic and Indian Ocean; (b) an Advisory Council for aquaculture; (c) an Advisory Council for markets; (d) an Advisory Council for the Black Sea. 3. Each Advisory Council shall establish its rules of procedure. Article 44 Tasks of Advisory Councils 1. When applying this Regulation, the Commission shall, where relevant, consult the Advisory Councils. 2. Advisory Councils may: (a) submit recommendations and suggestions on matters relating to the management of fisheries and the socio-economic and conservation aspects of fisheries and aquaculture to the Commission and to the Member State concerned, and, in particular, recommendations on how to simplify rules on fisheries management; (b) inform the Commission and Member States of problems relating to the management and the socio-economic and conservation aspects of fisheries and, where appropriate, of aquaculture in their geographical area or field of competence and propose solutions to overcome those problems; (c) contribute, in close cooperation with scientists, to the collection, supply and analysis of data necessary for the development of conservation measures. If an issue is of common interest to two or more Advisory Councils, they shall coordinate their positions with a view to adopting joint recommendations on that issue. 3. Advisory Councils shall be consulted on joint recommendations pursuant to Article 18. They may also be consulted by the Commission and by Member States in respect of other measures. Their advice shall be taken into account. Those consultations shall be without prejudice to the consultation of STECF or other scientific bodies. The opinions of the Advisory Councils may be submitted to all Member States concerned and to the Commission. 4. The Commission and, where relevant, the Member State concerned shall reply within two months to any recommendation, suggestion or information received pursuant to paragraph 1. Where the final measures that are adopted diverge from the Advisory Councils' opinions, recommendations and suggestions received pursuant to paragraph 1, the Commission or the Member State concerned shall state detailed reasons for the divergence. Article 45 Composition, functioning and funding of Advisory Councils 1. Advisory Councils shall be composed of: (a) organisations representing the fisheries and, where appropriate, aquaculture operators, and representatives of the processing and marketing sectors; (b) other interest groups affected by the CFP (e.g. environmental organisations and consumer groups). 2. Each Advisory Council shall consist of a general assembly and an executive committee, including, as appropriate, a secretariat and working groups to deal with issues of regional cooperation pursuant to Article 18, and shall adopt the measures necessary for its functioning. 3. Advisory Councils shall function and receive financing as provided for in Annex III. 4. The Commission shall be empowered to adopt delegated acts, in accordance with Article 46, laying down detailed rules on the functioning of Advisory Councils. PART XII PROCEDURAL PROVISIONS Article 46 Exercise of delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 11(2), Article 15(2), (3), (6), (7) and Article 45(4) shall be conferred on the Commission for a period of five years from 29 December 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 11(2), Article 15(2), (3), (6), (7) and Article 45(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 11(2), Article 15(2), (3), (6), (7) and Article 45(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 47 Committee procedure 1. The Commission shall be assisted by a Committee for fisheries and aquaculture. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion on a draft implementing act to be adopted pursuant to Article 23, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. PART XIII FINAL PROVISIONS Article 48 Repeals and amendments 1. Regulation (EC) No 2371/2002 is repealed. References to the repealed Regulation shall be construed as references to this Regulation. 2. Decision 2004/585/EC is repealed with effect from the entry into force of the rules adopted under Article 45(4) of this Regulation. 3. Article 5 of Council Regulation (EC) No 1954/2003 (25) shall be deleted. 4. Council Regulation (EC) No 639/2004 (26) is repealed. 5. In Article 105 of Regulation (EC) No 1224/2009, the following paragraph is inserted: "3a. By way of derogation from paragraphs 2 and 3, no multiplying factor shall be applied to catches which are subject to an obligation to land in accordance with Article 15 of the Regulation (EU) No 1380/2013 of the European Parliament and of the Council (27), provided that the extent of overfishing relative to the permitted landings does not exceed 10 %. Article 49 Review The Commission shall report to the European Parliament and to the Council on the functioning of the CFP by 31 December 2022. Article 50 Annual report The Commission shall report annually to the European Parliament and to the Council on the progress on achieving maximum sustainable yield and on the situation of fish stocks, as early as possible following the adoption of the yearly Council Regulation fixing the fishing opportunities available in Union waters and, in certain non-Union waters, to Union vessels. Article 51 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 January 2014. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 11 December 2013. For the European Parliament The President M. SCHULZ For the Council The President V. LEŠKEVIČIUS (1) OJ C 181, 21.6.2012, p. 183. (2) OJ C 225, 27.7.2012, p. 20. (3) Position of the European Parliament of 6 February 2013 (not yet published in the Official Journal) and position of the Council at first reading of 17 October 2013 (not yet published in the Official Journal). Position of the European Parliament of 9 December 2013 (not yet published in the Official Journal). (4) Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (OJ L 358, 31.12.2002, p. 59). (5) The United Nations Convention on the Law of the Sea and of the Agreement on the implementation of Part XI thereof (OJ L 179, 23.6.1998, p. 3). (6) Council Decision 98/392/EC of 23 March 1998 concerning the conclusion by the European Community of the United Nations Convention of 10 December 1982 on the Law of the Sea and the Agreement of 28 July 1994 relating to the implementation of Part XI thereof (OJ L 179, 23.6.1998, p. 1). (7) Council Decision 98/414/EC of 8 June 1998 on the ratification by the European Community of the Agreement for the implementing of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the conservation and management of straddling stocks and highly migratory fish stocks (OJ L 189, 3.7.1998, p. 14). (8) Agreement on the implementation of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the conservation and management of straddling fish stocks and highly migratory fish stocks (OJ L 189, 3.7.1998, p. 16). (9) Council Decision 96/428/EC of 25 June 1996 on acceptance by the Community of the Agreement to promote compliance with international conservation and management measures by fishing vessels on the high seas (OJ L 177, 16.7.1996, p. 24). (10) Agreement to promote compliance with international conservation and management measures by fishing vessels on the high seas (OJ L 177, 16.7.1996, p. 26). (11) Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19). (12) Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). (13) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). (14) Council resolution of 3 November 1976 on certain external aspects of the creation of a 200-mile fishing zone in the Community with effect from 1 January 1977 (OJ C 105, 7.5.1981, p. 1). (15) Commission Decision 2005/629/EC of 26 August 2005 establishing a Scientific, Technical and Economic Committee for Fisheries (OJ L 225, 31.8.2005, p. 18). (16) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (17) Council Decision 2004/585/EC of 19 July 2004 establishing Regional Advisory Councils under the Common Fisheries Policy (OJ L 256, 3.8.2004, p. 17). (18) Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea, amending Regulation (EEC) No 2847/93 and repealing Regulation (EC) No 1626/94 (OJ L 409, 30.12.2006, p. 11). (19) Council Regulation (EEC) No 2930/86 of 22 September 1986 defining characteristics for fishing vessels (OJ L 274, 25.9.1986, p. 1). (20) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (21) Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1). (22) ICES (International Council for the Exploration of the Sea) zones are as defined in Regulation (EC) No 218/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (OJ L 87, 31.3.2009, p. 70). (23) CECAF (Eastern Central Atlantic or FAO major fishing zone 34) zones are as defined in Regulation (EC) No 216/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in certain areas other than those of the North Atlantic (OJ L 87, 31.3.2009, p. 1). (24) Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (See page 1 of this Official Journal). (25) Council Regulation (EC) No 1954/2003 of 4 November 2003 on the management of the fishing effort relating to certain Community fishing areas and resources and modifying Regulation (EC) No 2847/93 and repealing Regulations (EC) No 685/95 and (EC) No 2027/95 (OJ L 289, 7.11.2003, p. 1). (26) Council Regulation (EC) No 639/2004 of 30 March 2004 on the management of fishing fleets registered in the Community outermost regions (OJ L 102, 7.4.2004, p. 9). (27) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 23)". ANNEX I ACCESS TO COASTAL WATERS WITHIN THE MEANING OF ARTICLE 5(2) 1. Coastal waters of the united kingdom A. ACCESS FOR FRANCE Geographical area Species Importance or particular characteristics United Kingdom coast (6 to 12 nautical miles) 1. Berwick-upon-Tweed east Coquet Island east Herring Unlimited 2. Flamborough Head east Spurn Head east Herring Unlimited 3. Lowestoft east Lyme Regis south All species Unlimited 4. Lyme Regis south Eddystone south Demersal Unlimited 5. Eddystone south Longships south-west Demersal Unlimited Scallops Unlimited Lobster Unlimited Crawfish Unlimited 6. Longships south-west Hartland Point north-west Demersal Unlimited Crawfish Unlimited Lobster Unlimited 7. Hartland Point to a line from the north of Lundy Island Demersal Unlimited 8. From a line due west Lundy Island to Cardigan Harbour All species Unlimited 9. Point Lynas North Morecambe Light Vessel east All species Unlimited 10. County Down Demersal Unlimited 11. New Island north-east Sanda Island south-west All species Unlimited 12. Port Stewart north Barra Head west All species Unlimited 13. Latitude 57°40'N Butt of Lewis west All species, except shellfish Unlimited 14. St Kilda, Flannan Islands All species Unlimited 15. West of the line joining Butt of Lewis lighthouse to the point 59°30'N-5°45'W All species Unlimited B. ACCESS FOR IRELAND Geographical area Species Importance or particular characteristics United Kingdom coast (6 to 12 nautical miles) 1. Point Lynas north Mull of Galloway south Demersal Unlimited Nephrops Unlimited 2. Mull of Oa west Barra Head west Demersal Unlimited Nephrops Unlimited C. ACCESS FOR GERMANY Geographical area Species Importance or particular characteristics United Kingdom coast (6 to 12 nautical miles) 1. East of Shetlands and Fair Isle between lines drawn due south-east from Sumbrugh Head lighthouse due north-east from Skroo lighthouse and due south-west from Skadan lighthouse Herring Unlimited 2. Berwick-upon-Tweed east, Whitby High lighthouse east Herring Unlimited 3. North Foreland lighthouse east, Dungeness new lighthouse south Herring Unlimited 4. Zone around St Kilda Herring Unlimited Mackerel Unlimited 5. Butt of Lewis lighthouse west to the line joining Butt of Lewis lighthouse and the point 59°30'N-5°45'W Herring Unlimited 6. Zone around North Rona and Sulisker (Sulasgeir) Herring Unlimited D. ACCESS FOR THE NETHERLANDS Geographical area Species Importance or particular characteristics United Kingdom coast (6 to 12 nautical miles) 1. East of Shetlands and Fair Isle between lines drawn due south-east from Sumburgh Head lighthouse due north-east from Skroo lighthouse and due south-west from Skadan lighthouse Herring Unlimited 2. Berwick upon Tweed east, Flamborough Head east Herring Unlimited 3. North Foreland east, Dungeness new lighthouse south Herring Unlimited E. ACCESS FOR BELGIUM Geographical area Species Importance or particular characteristics United Kingdom coast (6 to 12 nautical miles) 1. Berwick upon Tweed east Coquet Island east Herring Unlimited 2. Cromer north North Foreland east Demersal Unlimited 3. North Foreland east Dungeness new lighthouse south Demersal Unlimited Herring Unlimited 4. Dungeness new lighthouse south, Selsey Bill south Demersal Unlimited 5. Straight Point south-east, South Bishop north-west Demersal Unlimited 2. Coastal waters of ireland A. ACCESS FOR FRANCE Geographical area Species Importance or particular characteristics Irish coast (6 to 12 nautical miles) 1. Erris Head north-west Sybil Point west Demersal Unlimited Nephrops Unlimited 2. Mizen Head south Stags south Demersal Unlimited Nephrops Unlimited Mackerel Unlimited 3. Stags south Cork south Demersal Unlimited Nephrops Unlimited Mackerel Unlimited Herring Unlimited 4. Cork south, Carnsore Point south All species Unlimited 5. Carnsore Point south, Haulbowline south-east All species, except shellfish Unlimited B. ACCESS FOR THE UNITED KINGDOM Geographical area Species Importance or particular characteristics Irish coast (6 to 12 miles) 1. Mine Head south Hook Point Demersal Unlimited Herring Unlimited Mackerel Unlimited 2. Hook Point Carlingford Lough Demersal Unlimited Herring Unlimited Mackerel Unlimited Nephrops Unlimited Scallops Unlimited C. ACCESS FOR THE NETHERLANDS Geographical area Species Importance or particular characteristics Irish coast (6 to 12 miles) 1. Stags south Carnsore Point south Herring Unlimited Mackerel Unlimited D. ACCESS FOR GERMANY Geographical area Species Importance or particular characteristics Irish coast (6 to 12 nautical miles) 1. Old Head of Kinsale south Carnsore Point south Herring Unlimited 2. Cork south Carnsore Point south Mackerel Unlimited E. ACCESS FOR BELGIUM Geographical area Species Importance or particular characteristics Irish coast (6 to 12 nautical miles) 1. Cork south Carnsore Point south Demersal Unlimited 2. Wicklow Head east Carlingford Lough south-east Demersal Unlimited 3. Coastal waters of belgium Geographical area Member State Species Importance or particular characteristics 3 to 12 nautical miles Netherlands All species Unlimited France Herring Unlimited 4. Coastal waters of denmark Geographical area Member State Species Importance or particular characteristics North Sea coast (Danish/German frontier to Hanstholm) (6 to 12 nautical miles) Danish/German frontier to Blåvands Huk Germany Flatfish Unlimited Shrimps and prawns Unlimited Netherlands Flatfish Unlimited Roundfish Unlimited Blåvands Huk to Bovbjerg Belgium Cod Unlimited only from 1 June to 31 July Haddock Unlimited only from 1 June to 31 July Germany Flatfish Unlimited Netherlands Plaice Unlimited Sole Unlimited Thyborøn to Hanstholm Belgium Whiting Unlimited only from 1 June to 31 July Plaice Unlimited only from 1 June to 31 July Germany Flatfish Unlimited Sprat Unlimited Cod Unlimited Saithe Unlimited Haddock Unlimited Mackerel Unlimited Herring Unlimited Whiting Unlimited Netherlands Cod Unlimited Plaice Unlimited Sole Unlimited Skagerrak (Hanstholm to Skagen) (4 to 12 nautical miles) Belgium Plaice Unlimited only from 1 June to 31 July Germany Flatfish Unlimited Sprat Unlimited Cod Unlimited Saithe Unlimited Haddock Unlimited Mackerel Unlimited Herring Unlimited Whiting Unlimited Netherlands Cod Unlimited Plaice Unlimited Sole Unlimited Kattegat (3 to 12 miles) Germany Cod Unlimited Flatfish Unlimited Nephrops Unlimited Herring Unlimited North of Zeeland to the parallel of the latitude passing through Forsnæs lighthouse Germany Sprat Unlimited Baltic Sea (including Belts, Sound, Bornholm) (3 to 12 nautical miles) Germany Flatfish Unlimited Cod Unlimited Herring Unlimited Sprat Unlimited Eel Unlimited Salmon Unlimited Whiting Unlimited Mackerel Unlimited Skagerrak (4 to 12 miles) Sweden All species Unlimited Kattegat (3 to 12 miles (1)) Sweden All species Unlimited Baltic Sea (3 to 12 miles) Sweden All species Unlimited 5. Coastal waters of germany Geographical area Member State Species Importance or particular characteristics North Sea coast (3 to 12 nautical miles) all coasts Denmark Demersal Unlimited Sprat Unlimited Sandeel Unlimited Netherlands Demersal Unlimited Shrimps and prawns Unlimited Danish/German frontier to the northern tip of Amrum at 54°43′N Denmark Shrimps and prawns Unlimited Zone around Helgoland United Kingdom Cod Unlimited Plaice Unlimited Baltic coast (3 to 12 miles) Denmark Cod Unlimited Plaice Unlimited Herring Unlimited Sprat Unlimited Eel Unlimited Whiting Unlimited Mackerel Unlimited 6. Coastal waters of france and the overseas departments Geographical area Member State Species Importance or particular characteristics North-east Atlantic coast (6 to 12 nautical miles) Belgian/French frontier to east of Departement Manche (Vire-Grandcamp les Bains estuary 49° 23' 30" N-1° 2 'WNNE) Belgium Demersal Unlimited Scallops Unlimited Netherlands All Species Unlimited Dunkerque (2° 20' E) to Cap d'Antifer (0° 10' E) Germany Herring Unlimited only from 1 October to 31 December Belgian/French frontier to Cap d'Alprech west (50° 42 30" N — 1° 33' 30" E) United Kingdom Herring Unlimited Atlantic Coast (6 to 12 nautical miles) Spanish/French frontier to 46° 08′ N Spain Anchovies Directed fishing, unlimited only from 1 March to 30 June Fishing for live bait from 1 July to 31 October only Sardines Unlimited only from 1 January to 28 February and from 1 July to 31 December In addition, activities relating to the abovementioned species must be pursued in accordance with, and within the limits of, the activities pursued during 1984 Mediterranean coast (6 to 12 nautical miles) Spanish frontier Cap Leucate Spain All species Unlimited 7. Coastal waters of spain Geographical area Member State Species Importance or particular characteristics Atlantic coast (6 to 12 nautical miles) French/Spanish frontier to Cap Mayor lighthouse (3° 47' W) France Pelagic Unlimited in accordance with, and within the limits of, the activities pursued during 1984 Mediterranean coast (6 to 12 nautical miles) French frontier/Cap Creus France All species Unlimited 8. Coastal waters of croatia (2) Geographical area Member State Species Importance or particular characteristics 12 miles limited to the sea area under the sovereignty of Croatia situated to the north of the 45 degrees and 10 minutes parallel north latitude along the west Istrian coast, from the outer limit of the territorial sea of Croatia, where this parallel touches the land of the west Istrian coast (the cape Grgatov rt Funtana) Slovenia Demersal and small pelagic species including sardine and anchovy 100 tonnes for a maximum number of 25 fishing vessels which includes 5 fishing vessels equipped with trawl nets 9. Coastal waters of the netherlands Geographical area Member State Species Importance or particular characteristics (3 to 12 nautical miles) whole coast Belgium All species Unlimited Denmark Demersal Unlimited Sprat Unlimited Sandeel Unlimited Horse-mackerel Unlimited Germany Cod Unlimited Shrimps and prawns Unlimited (6 to 12 nautical miles) whole coast France All species Unlimited Texel south point, west to the Netherlands/German frontier United Kingdom Demersal Unlimited 10. Coastal waters of slovenia (3) Geographical area Member State Species Importance or particular characteristics 12 miles limited to the sea area under the sovereignty of Slovenia situated to the north of the 45 degrees and 10 minutes parallel north latitude along the west Istrian coast, from the outer limit of the territorial sea of Croatia, where this parallel touches the land of the west Istrian coast (the cape Grgatov rt Funtana) Croatia Demersal and small pelagic species including sardine and anchovy 100 tonnes for a maximum number of 25 fishing vessels which includes 5 fishing vessels equipped with trawl nets 11. Coastal waters of finland Geographical area Member State Species Importance or particular characteristics Baltic Sea (4 to 12 miles) (4) Sweden All species Unlimited 12. Coastal waters of sweden Geographical area Member State Species Importance or particular characteristics Skagerrak (4 to 12 nautical miles) Denmark All species Unlimited Kattegat (3 to 12 miles (5)) Denmark All species Unlimited Baltic Sea (4 to 12 miles) Denmark All species Unlimited Finland All species Unlimited (1) Measured from the coastline. (2) The above mentioned regime shall apply from the full implementation of the arbitration award resulting from the Arbitration Agreement between the Government of the Republic of Slovenia and the Government of the Republic of Croatia, signed in Stockholm on 4 November 2009. (3) The above mentioned regime shall apply from the full implementation of the arbitration award resulting from the Arbitration Agreement between the Government of the Republic of Slovenia and the Government of the Republic of Croatia, signed in Stockholm on 4 November 2009. (4) 3 to 12 miles around Bogskär Isles. (5) Measured from the coastline. ANNEX II FISHING CAPACITY CEILINGS Capacity ceilings Member State GT kW Belgium 18 962 51 586 Bulgaria 7 250 62 708 Denmark 88 762 313 333 Germany 71 117 167 078 Estonia 21 677 52 566 Ireland 77 568 210 083 Greece 84 123 469 061 Spain (including outermost regions) 423 550 964 826 France (including outermost regions) 214 282 1 166 328 Croatia 53 452 426 064 Italy 173 506 1 070 028 Cyprus 11 021 47 803 Latvia 46 418 58 496 Lithuania 73 489 73 516 Malta 14 965 95 776 Netherlands 166 859 350 736 Poland 38 270 90 650 Portugal (including outermost regions) 114 549 386 539 Romania 1 908 6 356 Slovenia 675 8 867 Finland 18 066 181 717 Sweden 43 386 210 829 United Kingdom 231 106 909 141 Capacity ceilings Outermost regions of the Union GT kW Spain Canary Islands: L (1) < 12 m. Union waters 2 617 20 863 Canary Islands: L > 12 m. Union waters 3 059 10 364 Canary Islands: L > 12 m. International and third country waters 28 823 45 593 France Reunion Island: Demersal and pelagic species. L < 12 m 1 050 19 320 Reunion Island: Pelagic species. L > 12 m 10 002 31 465 French Guyana: Demersal and pelagic species. Length < 12 m 903 11 644 French Guyana: Shrimp vessels 7 560 19 726 French Guyana: Pelagic species. Offshore vessels. 3 500 5 000 Martinique: Demersal and pelagic species. L < 12 m 5 409 142 116 Martinique: Pelagic species. L > 12 m 1 046 3 294 Guadeloupe: Demersal and pelagic species. L < 12 m 6 188 162 590 Guadeloupe: Pelagic species. L > 12 m 500 1 750 Portugal Madeira: Demersal species. L < 12 m 604 3 969 Madeira: Demersal and pelagic species. L > 12 m 4 114 12 734 Madeira: Pelagic species. Seine. L > 12 m 181 777 Azores: Demersal species. L < 12 m 2 617 29 870 Azores: Demersal and pelagic species. L > 12 m 12 979 25 721 (1) "L" means overall length of a vessel. ANNEX III ADVISORY COUNCILS 1. Name and area of competence of Advisory Councils Name Areas of competence Baltic Sea ICES zones IIIb, IIIc and IIId Black Sea GFCM geographical sub-area as defined in Resolution GFCM/33/2009/2 Mediterranean Sea Maritime Waters of the Mediterranean of the East of line 5°36′ West North Sea ICES zones IV and IIIa North Western waters ICES zones V (excluding Va and only Union waters of Vb), VI and VII South Western waters ICES zones VIII, IX and X (waters around Azores), and CECAF zones 34.1.1, 34.1.2 and 34.2.0 (waters around Madeira and the Canary Islands) Outermost regions Union waters around the outermost regions as referred to in the first paragraph of Article 349 of the Treaty divided into three sea basins: West Atlantic, East Atlantic, Indian Ocean Pelagic stocks (blue whiting, mackerel, horse mackerel, herring, boarfish) All geographical areas excluding the Baltic Sea and the Mediterranean Sea High seas/long distance fleet All non Union-waters Aquaculture Aquaculture, as defined in Article 4 Markets All market areas 2. Functioning and funding of Advisory Councils (a) In the general assembly and executive committee, 60 % of the seats shall be allotted to representatives of fishermen and for the Aquaculture Advisory Council, aquaculture operators, and representatives of the processing and marketing sectors, and 40 % to representatives of the other interest groups affected by the Common Fisheries Policy, for example environmental organisations and consumer groups. (b) Except for the Advisory Council for Aquaculture and for the Advisory Council for Markets, at least one representative of the catching subsector from each Member State concerned shall be member of the executive committee. (c) The members of the executive committee shall, where possible, adopt recommendations by consensus. If no consensus can be reached, dissenting opinions expressed by members shall be recorded in the recommendations adopted by the majority of the members present and voting. (d) Each Advisory Council shall designate a chairperson by consensus. The chairperson shall act impartially. (e) Each Advisory Council shall adopt the measures necessary to ensure transparency and the respect of all opinions expressed. (f) Recommendations adopted by the executive committee shall be made available immediately to the general assembly, the Commission, Member States concerned and, upon request, to any member of the public. (g) The meetings of the general assembly shall be open to the public. The meetings of the executive committee shall be open to the public unless, in exceptional cases, decided otherwise by a majority of the executive committee. (h) European and national organisations representing the fisheries sector and other interest groups may propose members to the Member States concerned. Those Member States shall agree on the members of the general assembly. (i) Representatives of national and regional administrations that have fisheries interests in the area concerned and researchers from the Member States' scientific and fisheries research institutes and from the international scientific institutions that advise the Commission shall be allowed to participate in Advisory Council meetings as active observers. Any other qualified scientist may also be invited. (j) Representatives of the European Parliament and of the Commission may take part as active observers in Advisory Council meetings. (k) When issues that affect them are discussed, representatives of the fisheries sector and other interest groups from third countries, including representatives from RFMOs, that have a fishing interest in the area or fisheries covered by an Advisory Council, may be invited to participate as active observers. (l) Advisory Councils may apply for Union financial assistance as bodies pursuing an aim of general European interest. (m) The Commission shall sign a grant agreement with each Advisory Council to contribute to its operational costs, including translation and interpretation costs. (n) The Commission may carry out all verifications it considers necessary to ensure compliance with the tasks assigned to the Advisory Councils. (o) Each Advisory Council shall transmit annually its budget and a report of its activities to the Commission and to the Member States concerned. (p) The Commission or the Court of Auditors may at any time arrange for an audit to be carried out either by an outside body of its choice or by the Commission or the Court of Auditors departments themselves. (q) Each Advisory Council shall appoint a certified auditor for the period during which it benefits from Union funds.

The EU’s common fisheries policy The EU’s common fisheries policy SUMMARY OF: Regulation (EU) No 1380/2013 on the common fisheries policy WHAT IS THE AIM OF THE REGULATION? The regulation includes the basic rules of the common fisheries policy (CFP) in the European Union (EU). The CFP aims to ensure that fishing and aquaculture activities contribute to long-term environmental, economic and social sustainability. In line with the European Green Deal (see summary) and the biodiversity strategy 2030 (see summary), EU fisheries are governed by the precautionary principle in order to limit the impact of fishing activities on the marine ecosystem. The CFP builds on four pillars: fisheries management;international policy;market and trade policy; andfinancial support, i.e. the European Maritime, Fisheries and Aquaculture Fund (see summary). The CFP establishes rules for the management of fisheries, thus contributing to the conservation of marine biological resources, increased productivity, a fair standard of living for the fisheries sector, stable markets and the availability of food supplies at reasonable prices. Regarding market measures and financial support, the CFP also covers freshwater biological resources and aquaculture activities, along with the processing and marketing of fishery and aquaculture products. KEY POINTS Fisheries management aims to enable fishers to maximise their catches without threatening the reproduction of fish stocks (their ‘maximum sustainable yield’*. To this end, total allowable catches (or ‘fishing opportunities’) are set for most commercial fish stocks. Fishing levels had to conform to maximum sustainable yield levels for all stocks by 2015, if possible, and no later than 2020. The management of fish stocks is based on scientific advice. EU Member States must collect, manage and make available the data needed for scientific advice. This includes biological, environmental and socioeconomic data. Data collection activities are financially supported by the EU. By introducing a landing obligation*, the CFP aims to end the wasteful practice of returning unwanted catches to the sea (discarding). The landing obligation was gradually phased in over the 2015–2019 period and is now fully in force, requiring fishers to land all catches of regulated commercial species. Multiannual plans set targets for the management of fish stocks. Where the adoption of multiannual plans or management plans that include discard plans takes longer than envisaged, Regulation (EU) 2017/2092 (amending Regulation (EU) No 1380/2013) empowers the European Commission to adopt discard plans. Technical measures are a broad set of rules that govern how, where and when fishers may fish. They are established for all European sea basins, but they differ considerably from one sea basin to another, reflecting regional circumstances. The CFP decentralises decision-making by bringing it closer to the fishing grounds (a process known as regionalisation). It provides for the establishment of advisory councils for each of the geographical areas. Member States with a management interest in a given area can propose detailed measures, which the Commission can adopt into EU law. A fisheries control system ensures compliance with the CFP rules, including the fight against illegal, unreported and unregulated fishing (Regulation (EC) No 1005/2008 – see summary). Regulation (EU) No 1026/2012 (see summary) lays down the rules that apply to conserving fish stocks in countries with unsustainable fishing. New marketing standards with respect to labelling, quality and traceability allow consumers to be better informed about the origin of the fish they buy and its mode of production. The sustainability principle also applies to EU vessels fishing outside EU waters. The Commission is granted the power to negotiate and conclude sustainable fisheries partnership agreements on behalf of the EU with certain non-EU partner countries. These agreements: allow EU vessels to fish for surplus stocks in the partner country’s exclusive economic zone* in a legally regulated environment in return for a financial contribution;focus on resource conservation and environmental sustainability, ensuring that all EU vessels are subject to the same rules of control and transparency. Member States must support the development of sustainable aquaculture through multiannual national plans. Review of the reformed CFP Every year, the Commission publishes a communication outlining progress on the situation of fish stocks and launching a wide public consultation on the fixing of annual fishing opportunities for the following year. This communication assesses the progress made towards sustainable fishing in the EU and reviews the balance between fishing capacity and fishing opportunities, the sector’s socio-economic performance and the implementation of the landing obligation. It also sets out the rationale for the proposal on fishing opportunities for the following year. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2014. BACKGROUND The CFP was first launched in 1970. It has undergone several reforms, the most recent of which took effect on 1 January 2014. For further information, see: Common fisheries policy (CFP) (European Commission). KEY TERMS Maximum sustainable yield. The highest theoretical equilibrium yield that can be continuously taken on average from a stock under existing average environmental conditions without significantly affecting the reproduction process. Landing obligation. The requirement for EU vessels to land all catches to end the wasteful practice of returning unwanted catches to the sea. Exclusive economic zone. An area of coastal water and seabed within a certain distance of a country’s coastline, to which the country claims exclusive rights for fishing, drilling and other economic activities. MAIN DOCUMENT Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the common fisheries policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, pp. 22–61). Successive amendments to Regulation (EU) No 1380/2013 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2021/1139 of the European Parliament and of the Council of 7 July 2021 establishing the European Maritime, Fisheries and Aquaculture Fund and amending Regulation (EU) 2017/1004 (OJ L 247, 13.7.2021, pp. 1–49). Communication from the Commission to the European Parliament and the Council – Towards more sustainable fishing in the EU: state of play and orientations for 2022 (COM(2021) 279 final, 9.6.2021). Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions – The European Green Deal (COM(2019) 640 final, 11.12.2019). Regulation (EU) 2019/1241 of the European Parliament and of the Council of 20 June 2019 on the conservation of fisheries resources and the protection of marine ecosystems through technical measures, amending Council Regulations (EC) No 1967/2006, (EC) No 1224/2009 and Regulations (EU) No 1380/2013, (EU) 2016/1139, (EU) 2018/973, (EU) 2019/472 and (EU) 2019/1022 of the European Parliament and of the Council, and repealing Council Regulations (EC) No 894/97, (EC) No 850/98, (EC) No 2549/2000, (EC) No 254/2002, (EC) No 812/2004 and (EC) No 2187/2005 (OJ L 198, 25.7.2019, pp. 105–201). See consolidated version. Regulation (EU) 2017/1004 of the European Parliament and of the Council of 17 May 2017 on the establishment of a Union framework for the collection, management and use of data in the fisheries sector and support for scientific advice regarding the common fisheries policy and repealing Council Regulation (EC) No 199/2008 (OJ L 157, 20.6.2017, pp. 1–21). See consolidated version. Regulation (EU) 2016/1627 of the European Parliament and of the Council of 14 September 2016 on a multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean, and repealing Council Regulation (EC) No 302/2009 (OJ L 252, 16.9.2016, pp. 1–52). See consolidated version. Regulation (EU) No 1026/2012 of the European Parliament and of the Council of 25 October 2012 on certain measures for the purpose of the conservation of fish stocks in relation to countries allowing non-sustainable fishing (OJ L 316, 14.11.2012, pp. 34–37). Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, pp. 1–50). See consolidated version. Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, pp. 1–32). See consolidated version. last update 21.03.2022

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16.6.2017 EN Official Journal of the European Union L 154/1 REGULATION (EU) 2017/1001 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 June 2017 on the European Union trade mark (codification) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular the first paragraph of Article 118 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Council Regulation (EC) No 207/2009 (2) has been substantially amended several times (3). In the interests of clarity and rationality, that Regulation should be codified. (2) Council Regulation (EC) No 40/94 (4), which was codified in 2009 as Regulation (EC) No 207/2009, created a system of trade mark protection specific to the Union which provided for the protection of trade marks at the level of the Union, in parallel to the protection of trade marks available at the level of the Member States in accordance with the national trade mark systems, harmonised by Council Directive 89/104/EEC (5), which was codified as Directive 2008/95/EC of the European Parliament and of the Council (6). (3) It is desirable to promote throughout the Union a harmonious development of economic activities and a continuous and balanced expansion by completing an internal market which functions properly and offers conditions which are similar to those obtaining in a national market. In order to establish a market of this kind and make it increasingly a single market, not only should barriers to free movement of goods and services be removed and arrangements be instituted which ensure that competition is not distorted, but, in addition, legal conditions should be laid down which enable undertakings to adapt their activities to the scale of the Union, whether in manufacturing and distributing goods or in providing services. For those purposes, trade marks enabling the products and services of undertakings to be distinguished by identical means throughout the entire Union, regardless of frontiers, should feature amongst the legal instruments which undertakings have at their disposal. (4) For the purpose of pursuing the Union's said objectives it would appear necessary to provide for Union arrangements for trade marks whereby undertakings can by means of one procedural system obtain EU trade marks to which uniform protection is given and which produce their effects throughout the entire area of the Union. The principle of the unitary character of the EU trade mark thus stated should apply unless otherwise provided for in this Regulation. (5) The barrier of territoriality of the rights conferred on proprietors of trade marks by the laws of the Member States cannot be removed by approximation of laws. In order to open up unrestricted economic activity in the whole of the internal market for the benefit of undertakings, it should be possible to register trade marks which are governed by a uniform Union law directly applicable in all Member States. (6) The experience acquired since the establishment of the Community trade mark system has shown that undertakings from within the Union and from third countries have accepted the system which has become a successful and viable complement and alternative to the protection of trade marks at the level of the Member States. (7) The Union law relating to trade marks nevertheless does not replace the laws of the Member States on trade marks. It would not in fact appear to be justified to require undertakings to apply for registration of their trade marks as EU trade marks. (8) National trade marks continue to be necessary for those undertakings which do not want protection of their trade marks at Union level, or which are unable to obtain Union-wide protection while national protection does not face any obstacles. It should be left to each person seeking trade mark protection to decide whether the protection is sought only as a national trade mark in one or more Member States, or only as an EU trade mark, or both. (9) The rights in an EU trade mark should not be obtained otherwise than by registration, and registration should be refused in particular if the trade mark is not distinctive, if it is unlawful or if it conflicts with earlier rights. (10) A sign should be permitted to be represented in any appropriate form using generally available technology, and thus not necessarily by graphic means, as long as the representation is clear, precise, self-contained, easily accessible, intelligible, durable and objective. (11) The protection afforded by an EU trade mark, the function of which is in particular to guarantee the trade mark as an indication of origin, should be absolute in the case of identity between the mark and the sign and the goods or services. The protection should apply also in cases of similarity between the mark and the sign and the goods or services. An interpretation should be given for the concept of similarity in relation to the likelihood of confusion. The likelihood of confusion, the appreciation of which depends on numerous elements and, in particular, on the recognition of the trade mark on the market, the association which can be made with the used or registered sign, the degree of similarity between the trade mark and the sign and between the goods or services identified, should constitute the specific condition for such protection. (12) In order to ensure legal certainty and full consistency with the principle of priority, under which a registered earlier trade mark takes precedence over later registered trade marks, it is necessary to provide that the enforcement of rights conferred by an EU trade mark should be without prejudice to the rights of proprietors acquired prior to the filing or priority date of the EU trade mark. This is in conformity with Article 16(1) of the Agreement on trade-related aspects of intellectual property rights of 15 April 1994. (13) Confusion as to the commercial source from which the goods or services emanate may occur when a company uses the same or a similar sign as a trade name in such a way that a link is established between the company bearing the name and the goods or services coming from that company. Infringement of an EU trade mark should therefore also comprise the use of the sign as a trade name or similar designation as long as the use is made for the purposes of distinguishing goods or services. (14) In order to ensure legal certainty and full consistency with specific Union legislation, it is appropriate to provide that the proprietor of an EU trade mark should be entitled to prohibit a third party from using a sign in comparative advertising where such comparative advertising is contrary to Directive 2006/114/EC of the European Parliament and of the Council (7). (15) In order to ensure trade mark protection and combat counterfeiting effectively, and in line with international obligations of the Union under the framework of the World Trade Organisation (WTO), in particular Article V of the General Agreement on Tariffs and Trade (GATT) on freedom of transit and, as regards generic medicines, the ‘Declaration on the TRIPS Agreement and public health’ adopted by the Doha WTO Ministerial Conference on 14 November 2001, the proprietor of an EU trade mark should be entitled to prevent third parties from bringing goods, in the course of trade, into the Union without being released for free circulation there, where such goods come from third countries and bear without authorisation a trade mark which is identical or essentially identical with the EU trade mark registered in respect of such goods. (16) To this effect, it should be permissible for EU trade mark proprietors to prevent the entry of infringing goods and their placement in all customs situations, including transit, transhipment, warehousing, free zones, temporary storage, inward processing or temporary admission, also when such goods are not intended to be placed on the market of the Union. In performing customs controls, the customs authorities should make use of the powers and procedures laid down in Regulation (EU) No 608/2013 of the European Parliament and the Council (8), also at the request of the right holders. In particular, the customs authorities should carry out the relevant controls on the basis of risk analysis criteria. (17) In order to reconcile the need to ensure the effective enforcement of trade mark rights with the necessity to avoid hampering the free flow of trade in legitimate goods, the entitlement of the proprietor of the EU trade mark should lapse where, during the subsequent proceedings initiated before the European Union trade mark court (‘EU trade mark court’) competent to take a substantive decision on whether the EU trade mark has been infringed, the declarant or the holder of the goods is able to prove that the proprietor of the EU trade mark is not entitled to prohibit the placing of the goods on the market in the country of final destination. (18) Article 28 of Regulation (EU) No 608/2013 provides that a right holder is to be liable for damages towards the holder of the goods where, inter alia, the goods in question are subsequently found not to infringe an intellectual property right. (19) Appropriate measures should be taken with a view to ensuring the smooth transit of generic medicines. With respect to international non-proprietary names (INN) as globally recognised generic names for active substances in pharmaceutical preparations, it is vital to take due account of the existing limitations on the effect of EU trade mark rights. Consequently, the proprietor of an EU trade mark should not have the right to prevent a third party from bringing goods into the Union without being released for free circulation there, based upon similarities between the INN for the active ingredient in the medicines and the trade mark. (20) In order to enable proprietors of EU trade marks to combat counterfeiting effectively, they should be entitled to prohibit the affixing of an infringing mark to goods and preparatory acts carried out prior to the affixing. (21) The exclusive rights conferred by an EU trade mark should not entitle the proprietor to prohibit the use of signs or indications by third parties which are used fairly and thus in accordance with honest practices in industrial and commercial matters. In order to ensure equal conditions for trade names and EU trade marks in the event of conflicts, given that trade names are regularly granted unrestricted protection against later trade marks, such use should be only considered to include the use of the personal name of the third party. It should further permit the use of descriptive or non-distinctive signs or indications in general. Furthermore, the proprietor should not be entitled to prevent the fair and honest use of the EU trade mark for the purpose of identifying or referring to the goods or services as those of the proprietor. Use of a trade mark by third parties to draw the consumer's attention to the resale of genuine goods that were originally sold by or with the consent of the proprietor of the EU trade mark in the Union should be considered as being fair as long as it is at the same time in accordance with honest practices in industrial and commercial matters. Use of a trade mark by third parties for the purpose of artistic expression should be considered as being fair as long as it is at the same time in accordance with honest practices in industrial and commercial matters. Furthermore, this Regulation should be applied in a way that ensures full respect for fundamental rights and freedoms, and in particular the freedom of expression. (22) It follows from the principle of free movement of goods that it is essential that the proprietor of an EU trade mark not be entitled to prohibit its use by a third party in relation to goods which have been put into circulation in the European Economic Area, under the trade mark, by him or with his consent, save where there exist legitimate reasons for the proprietor to oppose further commercialisation of the goods. (23) In order to ensure legal certainty and safeguard legitimately acquired trade mark rights, it is appropriate and necessary to lay down, without prejudice to the principle that the later trade mark cannot be enforced against the earlier trade mark, that proprietors of EU trade marks should not be entitled to oppose the use of a later trade mark if the later trade mark was acquired at a time when the earlier trade mark could not be enforced against the later trade mark. (24) There is no justification for protecting EU trade marks or, as against them, any trade mark which has been registered before them, except where the trade marks are actually used. (25) For reasons of equity and legal certainty, the use of an EU trade mark in a form that differs in elements which do not alter the distinctive character of that mark in the form in which it is registered should be sufficient to preserve the rights conferred regardless of whether the trade mark in the form as used is also registered. (26) An EU trade mark is to be regarded as an object of property which exists separately from the undertakings whose goods or services are designated by it. Accordingly, it should be capable of being transferred, of being charged as security in favour of a third party and of being the subject matter of licences. (27) Administrative measures are necessary at Union level for implementing in relation to every trade mark the trade mark law laid down by this Regulation. It is therefore essential, while retaining the Union's existing institutional structure and balance of powers, to provide for a European Union Intellectual Property Office (‘the Office’) which is independent in relation to technical matters and has legal, administrative and financial autonomy. To this end it is necessary and appropriate that the Office should be a body of the Union having legal personality and exercising the powers which are conferred on it by this Regulation, and that it should operate within the framework of Union law without detracting from the competences exercised by the Union institutions. (28) EU trade mark protection is granted in relation to specific goods or services whose nature and number determine the extent of protection afforded to the trade mark proprietor. It is therefore essential to lay down rules for the designation and classification of goods and services in this Regulation and to ensure legal certainty and sound administration by requiring that the goods and services for which trade mark protection is sought are identified by the applicant with sufficient clarity and precision to enable the competent authorities and economic operators, on the basis of the application alone, to determine the extent of the protection applied for. The use of general terms should be interpreted as only including all goods and services clearly covered by the literal meaning of the term. Proprietors of EU trade marks, which because of the practice of the Office prior to 22 June 2012 were registered in respect of the entire heading of a class of the system of classification established by the Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks of 15 June 1957, should be given the possibility to adapt their lists of goods and services in order to ensure that the content of the Register meets the requisite standard of clarity and precision in accordance with the case law of the Court of Justice of the European Union. (29) In order to avoid unnecessary delays in registering an EU trade mark, it is appropriate to lay down a regime of optional EU and national trade mark searches that should be flexible in terms of user needs and preferences. The optional EU and national trade mark searches should be complemented by the making available of all-encompassing, fast and powerful search engines for the use of the public free of charge within the context of cooperation between the Office and the central industrial property offices of the Member States, including the Benelux Office for Intellectual Property. (30) It is necessary to ensure that parties who are affected by decisions made by the Office are protected by the law in a manner which is suited to the special character of trade mark law. To that end, provision should be made for an appeal to lie from decisions of the various decision-making instances of the Office. A Board of Appeal of the Office should decide on the appeal. Decisions of the Boards of Appeal should, in turn, be amenable to actions before the General Court, which has jurisdiction to annul or to alter the contested decision. (31) In order to ensure the protection of EU trade marks the Member States should designate, having regard to their own national system, as limited a number as possible of national courts of first and second instance having jurisdiction in matters of infringement and validity of EU trade marks. (32) It is essential that decisions regarding the validity and infringement of EU trade marks have effect and cover the entire area of the Union, as this is the only way of preventing inconsistent decisions on the part of the courts and the Office and of ensuring that the unitary character of EU trade marks is not undermined. The provisions of Regulation (EU) No 1215/2012 of the European Parliament and of the Council (9) should apply to all actions at law relating to EU trade marks, save where this Regulation derogates from those rules. (33) Contradictory judgments should be avoided in actions which involve the same acts and the same parties and which are brought on the basis of an EU trade mark and parallel national trade marks. For this purpose, when the actions are brought in the same Member State, the way in which this is to be achieved is a matter for national procedural rules, which are not prejudiced by this Regulation, whilst when the actions are brought in different Member States, provisions modelled on the rules on lis pendens and related actions of Regulation (EU) No 1215/2012 appear appropriate. (34) With the aim of promoting convergence of practices and of developing common tools, it is necessary to establish an appropriate framework for cooperation between the Office and the industrial property offices of the Member States, including the Benelux Office for Intellectual Property, defining key areas of cooperation and enabling the Office to coordinate relevant common projects of interest to the Union and the Member States and to finance, up to a maximum amount, those projects. Those cooperation activities should be beneficial for undertakings using trade mark systems in Europe. For users of the Union regime laid down in this Regulation, the projects, particularly the databases for search and consultation purposes, should provide additional, inclusive, efficient tools that are free of charge to comply with the specific requirements arising from the unitary character of the EU trade mark. (35) It is desirable to facilitate friendly, expeditious and efficient dispute resolution by entrusting the Office with the establishment of a mediation centre the services of which could be used by any person with the aim of achieving a friendly settlement of disputes relating to EU trade marks and Community designs by mutual agreement. (36) The setting up of the EU trade mark system has resulted in increased financial burdens for the central industrial property offices and other authorities of the Member States. The additional costs are related to the handling of a higher number of opposition and invalidity proceedings involving EU trade marks or brought by proprietors of such trade marks; to the awareness-raising activities linked to the EU trade mark system; as well as to activities intended to ensure the enforcement of EU trade mark rights. It is, therefore, appropriate to ensure that the Office offset part of the costs incurred by Member States for the role they play in ensuring the smooth functioning of the EU trade mark system. The payment of such offsetting should be subject to the submission, by Member States, of relevant statistical data. The offsetting of costs should not be of such an extent that it would cause a budgetary deficit for the Office. (37) In order to guarantee the full autonomy and independence of the Office, it is considered necessary to grant it an autonomous budget whose revenue comes principally from fees paid by the users of the system. However, the Union budgetary procedure remains applicable as far as any subsidies chargeable to the general budget of the Union are concerned. Moreover, the auditing of accounts should be undertaken by the Court of Auditors. (38) In the interest of sound financial management, the accumulation by the Office of significant budgetary surpluses should be avoided. This should be without prejudice to the Office maintaining a financial reserve covering one year of its operational expenditure to ensure the continuity of its operations and the performance of its tasks. That reserve should only be used to ensure the continuity of the tasks of the Office as specified in this Regulation. (39) Given the essential importance of the amounts of fees payable to the Office for the functioning of the EU trade mark system and its complementary relationship as regards national trade mark systems, it is necessary to set those fee amounts directly in this Regulation in the form of an annex. The amounts of the fees should be fixed at a level which ensures that: first, the revenue they produce is in principle sufficient for the budget of the Office to be balanced; second, there is coexistence and complementarity between the EU trade mark and the national trade mark systems, also taking into account the size of the market covered by the EU trade mark and the needs of small and medium-sized enterprises; and third, the rights of proprietors of an EU trade mark are enforced efficiently in the Member States. (40) In order to ensure an effective, efficient and expeditious examination and registration of EU trade mark applications by the Office using procedures which are transparent, thorough, fair and equitable, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of specifying the details on the procedures for filing and examining an opposition and on the procedures governing the amendment of the application. (41) In order to ensure that an EU trade mark can be revoked or declared invalid in an effective and efficient way by means of transparent, thorough, fair and equitable procedures, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the procedures for revocation and declaration of invalidity. (42) In order to allow for an effective, efficient and complete review of decisions of the Office by the Boards of Appeal by means of a transparent, thorough, fair and equitable procedure which takes into account the principles laid down in this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the formal content of the notice of appeal, the procedure for the filing and examination of an appeal, the formal content and form of the Board of Appeal's decisions, and the reimbursement of the appeal fees. (43) In order to ensure a smooth, effective and efficient operation of the EU trade mark system, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the requirements as to the details on oral proceedings and the detailed arrangements for taking of evidence, the detailed arrangements for notification, the means of communication and the forms to be used by the parties to proceedings, the rules governing the calculation and duration of time limits, the procedures for the revocation of a decision or for cancellation of an entry in the Register, the detailed arrangements for the resumption of proceedings, and the details on representation before the Office. (44) In order to ensure an effective and efficient organisation of the Boards of Appeal, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the details on the organisation of the Boards of Appeal. (45) In order to ensure the effective and efficient registration of international trade marks in a manner that is fully consistent with the rules of the Protocol relating to the Madrid Agreement concerning the international registration of marks, adopted at Madrid on 27 June 1989 (‘Madrid Protocol’), the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the details on the procedures concerning the filing and examination of an opposition, including the necessary communications to be made to the World Intellectual Property Organisation (WIPO), and the details of the procedure concerning international registrations based on a basic application or basic registration relating to a collective mark, certification mark or guarantee mark. (46) It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (10). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (47) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of specifying the details concerning applications, requests, certificates, claims, regulations, notifications and any other document under the relevant procedural requirements established by this Regulation, as well as in respect of maximum rates for costs essential to the proceedings and actually incurred, details concerning publications in the European Union Trade Marks Bulletin and the Official Journal of the Office, the detailed arrangements for exchange of information between the Office and national authorities, detailed arrangements concerning translations of supporting documents in written proceedings, exact types of decisions to be taken by a single member of the opposition or cancellation divisions, details of the notification obligation pursuant to the Madrid Protocol, and detailed requirements regarding the request for territorial extension subsequent to international registration. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (11). (48) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 EU trade mark 1. A trade mark for goods or services which is registered in accordance with the conditions contained in this Regulation and in the manner herein provided is hereinafter referred to as a ‘European Union trade mark (“EU trade mark”)’. 2. An EU trade mark shall have a unitary character. It shall have equal effect throughout the Union: it shall not be registered, transferred or surrendered or be the subject of a decision revoking the rights of the proprietor or declaring it invalid, nor shall its use be prohibited, save in respect of the whole Union. This principle shall apply unless otherwise provided for in this Regulation. Article 2 Office 1. A European Union Intellectual Property Office (‘the Office’) is established. 2. All references in Union law to the Office for Harmonization in the Internal Market (Trade Marks and Designs) shall be read as references to the Office. Article 3 Capacity to act For the purpose of implementing this Regulation, companies or firms and other legal bodies shall be regarded as legal persons if, under the terms of the law governing them, they have the capacity in their own name to have rights and obligations of all kinds, to make contracts or accomplish other legal acts, and to sue and be sued. CHAPTER II THE LAW RELATING TO TRADE MARKS SECTION 1 Definition of an EU trade mark and obtaining an EU trade mark Article 4 Signs of which an EU trade mark may consist An EU trade mark may consist of any signs, in particular words, including personal names, or designs, letters, numerals, colours, the shape of goods or of the packaging of goods, or sounds, provided that such signs are capable of: (a) distinguishing the goods or services of one undertaking from those of other undertakings; and (b) being represented on the Register of European Union trade marks (‘the Register’), in a manner which enables the competent authorities and the public to determine the clear and precise subject matter of the protection afforded to its proprietor. Article 5 Persons who can be proprietors of EU trade marks Any natural or legal person, including authorities established under public law, may be the proprietor of an EU trade mark. Article 6 Means whereby an EU trade mark is obtained An EU trade mark shall be obtained by registration. Article 7 Absolute grounds for refusal 1. The following shall not be registered: (a) signs which do not conform to the requirements of Article 4; (b) trade marks which are devoid of any distinctive character; (c) trade marks which consist exclusively of signs or indications which may serve, in trade, to designate the kind, quality, quantity, intended purpose, value, geographical origin or the time of production of the goods or of rendering of the service, or other characteristics of the goods or service; (d) trade marks which consist exclusively of signs or indications which have become customary in the current language or in the bona fide and established practices of the trade; (e) signs which consist exclusively of: (i) the shape, or another characteristic, which results from the nature of the goods themselves; (ii) the shape, or another characteristic, of goods which is necessary to obtain a technical result; (iii) the shape, or another characteristic, which gives substantial value to the goods; (f) trade marks which are contrary to public policy or to accepted principles of morality; (g) trade marks which are of such a nature as to deceive the public, for instance as to the nature, quality or geographical origin of the goods or service; (h) trade marks which have not been authorised by the competent authorities and are to be refused pursuant to Article 6ter of the Paris Convention for the Protection of Industrial Property (‘Paris Convention’); (i) trade marks which include badges, emblems or escutcheons other than those covered by Article 6ter of the Paris Convention and which are of particular public interest, unless the consent of the competent authority to their registration has been given; (j) trade marks which are excluded from registration, pursuant to Union legislation or national law or to international agreements to which the Union or the Member State concerned is party, providing for protection of designations of origin and geographical indications; (k) trade marks which are excluded from registration pursuant to Union legislation or international agreements to which the Union is party, providing for protection of traditional terms for wine; (l) trade marks which are excluded from registration pursuant to Union legislation or international agreements to which the Union is party, providing for protection of traditional specialities guaranteed; (m) trade marks which consist of, or reproduce in their essential elements, an earlier plant variety denomination registered in accordance with Union legislation or national law, or international agreements to which the Union or the Member State concerned is a party, providing for protection of plant variety rights, and which are in respect of plant varieties of the same or closely related species. 2. Paragraph 1 shall apply notwithstanding that the grounds of non-registrability obtain in only part of the Union. 3. Paragraph 1(b), (c) and (d) shall not apply if the trade mark has become distinctive in relation to the goods or services for which registration is requested as a consequence of the use which has been made of it. Article 8 Relative grounds for refusal 1. Upon opposition by the proprietor of an earlier trade mark, the trade mark applied for shall not be registered: (a) if it is identical with the earlier trade mark and the goods or services for which registration is applied for are identical with the goods or services for which the earlier trade mark is protected; (b) if, because of its identity with, or similarity to, the earlier trade mark and the identity or similarity of the goods or services covered by the trade marks there exists a likelihood of confusion on the part of the public in the territory in which the earlier trade mark is protected; the likelihood of confusion includes the likelihood of association with the earlier trade mark. 2. For the purposes of paragraph 1, ‘earlier trade mark’ means: (a) trade marks of the following kinds with a date of application for registration which is earlier than the date of application for registration of the EU trade mark, taking account, where appropriate, of the priorities claimed in respect of those trade marks: (i) EU trade marks; (ii) trade marks registered in a Member State, or, in the case of Belgium, the Netherlands or Luxembourg, at the Benelux Office for Intellectual Property; (iii) trade marks registered under international arrangements which have effect in a Member State; (iv) trade marks registered under international arrangements which have effect in the Union; (b) applications for the trade marks referred to in point (a), subject to their registration; (c) trade marks which, on the date of application for registration of the EU trade mark, or, where appropriate, of the priority claimed in respect of the application for registration of the EU trade mark, are well known in a Member State, in the sense in which the words ‘well known’ are used in Article 6bis of the Paris Convention. 3. Upon opposition by the proprietor of the trade mark, a trade mark shall not be registered where an agent or representative of the proprietor of the trade mark applies for registration thereof in his own name without the proprietor's consent, unless the agent or representative justifies his action. 4. Upon opposition by the proprietor of a non-registered trade mark or of another sign used in the course of trade of more than mere local significance, the trade mark applied for shall not be registered where and to the extent that, pursuant to Union legislation or the law of the Member State governing that sign: (a) rights to that sign were acquired prior to the date of application for registration of the EU trade mark, or the date of the priority claimed for the application for registration of the EU trade mark; (b) that sign confers on its proprietor the right to prohibit the use of a subsequent trade mark. 5. Upon opposition by the proprietor of a registered earlier trade mark within the meaning of paragraph 2, the trade mark applied for shall not be registered where it is identical with, or similar to, an earlier trade mark, irrespective of whether the goods or services for which it is applied are identical with, similar to or not similar to those for which the earlier trade mark is registered, where, in the case of an earlier EU trade mark, the trade mark has a reputation in the Union or, in the case of an earlier national trade mark, the trade mark has a reputation in the Member State concerned, and where the use without due cause of the trade mark applied for would take unfair advantage of, or be detrimental to, the distinctive character or the repute of the earlier trade mark. 6. Upon opposition by any person authorised under the relevant law to exercise the rights arising from a designation of origin or a geographical indication, the trade mark applied for shall not be registered where and to the extent that, pursuant to the Union legislation or national law providing for the protection of designations of origin or geographical indications: (i) an application for a designation of origin or a geographical indication had already been submitted, in accordance with Union legislation or national law, prior to the date of application for registration of the EU trade mark or the date of the priority claimed for the application, subject to its subsequent registration; (ii) that designation of origin or geographical indication confers the right to prohibit the use of a subsequent trade mark. SECTION 2 Effects of an EU trade mark Article 9 Rights conferred by an EU trade mark 1. The registration of an EU trade mark shall confer on the proprietor exclusive rights therein. 2. Without prejudice to the rights of proprietors acquired before the filing date or the priority date of the EU trade mark, the proprietor of that EU trade mark shall be entitled to prevent all third parties not having his consent from using in the course of trade, in relation to goods or services, any sign where: (a) the sign is identical with the EU trade mark and is used in relation to goods or services which are identical with those for which the EU trade mark is registered; (b) the sign is identical with, or similar to, the EU trade mark and is used in relation to goods or services which are identical with, or similar to, the goods or services for which the EU trade mark is registered, if there exists a likelihood of confusion on the part of the public; the likelihood of confusion includes the likelihood of association between the sign and the trade mark; (c) the sign is identical with, or similar to, the EU trade mark irrespective of whether it is used in relation to goods or services which are identical with, similar to or not similar to those for which the EU trade mark is registered, where the latter has a reputation in the Union and where use of that sign without due cause takes unfair advantage of, or is detrimental to, the distinctive character or the repute of the EU trade mark. 3. The following, in particular, may be prohibited under paragraph 2: (a) affixing the sign to the goods or to the packaging of those goods; (b) offering the goods, putting them on the market, or stocking them for those purposes under the sign, or offering or supplying services thereunder; (c) importing or exporting the goods under the sign; (d) using the sign as a trade or company name or part of a trade or company name; (e) using the sign on business papers and in advertising; (f) using the sign in comparative advertising in a manner that is contrary to Directive 2006/114/EC. 4. Without prejudice to the rights of proprietors acquired before the filing date or the priority date of the EU trade mark, the proprietor of that EU trade mark shall also be entitled to prevent all third parties from bringing goods, in the course of trade, into the Union without being released for free circulation there, where such goods, including packaging, come from third countries and bear without authorisation a trade mark which is identical with the EU trade mark registered in respect of such goods, or which cannot be distinguished in its essential aspects from that trade mark. The entitlement of the proprietor of an EU trade mark pursuant to the first subparagraph shall lapse if, during the proceedings to determine whether the EU trade mark has been infringed, initiated in accordance with Regulation (EU) No 608/2013, evidence is provided by the declarant or the holder of the goods that the proprietor of the EU trade mark is not entitled to prohibit the placing of the goods on the market in the country of final destination. Article 10 Right to prohibit preparatory acts in relation to the use of packaging or other means Where the risk exists that the packaging, labels, tags, security or authenticity features or devices or any other means to which the mark is affixed could be used in relation to goods or services and such use would constitute an infringement of the rights of the proprietor of an EU trade mark under Article 9(2) and (3), the proprietor of that trade mark shall have the right to prohibit the following acts if carried out in the course of trade: (a) affixing a sign identical with, or similar to, the EU trade mark on packaging, labels, tags, security or authenticity features or devices or any other means to which the mark may be affixed; (b) offering or placing on the market, or stocking for those purposes, or importing or exporting, packaging, labels, tags, security or authenticity features or devices or any other means to which the mark is affixed. Article 11 Date from which rights against third parties prevail 1. The rights conferred by an EU trade mark shall prevail against third parties from the date of publication of the registration of the trade mark. 2. Reasonable compensation may be claimed in respect of acts occurring after the date of publication of an EU trade mark application, where those acts would, after publication of the registration of the trade mark, be prohibited by virtue of that publication. 3. A court seised of a case shall not decide upon the merits of that case until the registration has been published. Article 12 Reproduction of an EU trade mark in a dictionary If the reproduction of an EU trade mark in a dictionary, encyclopaedia or similar reference work gives the impression that it constitutes the generic name of the goods or services for which the trade mark is registered, the publisher of the work shall, at the request of the proprietor of the EU trade mark, ensure that the reproduction of the trade mark at the latest in the next edition of the publication is accompanied by an indication that it is a registered trade mark. Article 13 Prohibition of the use of an EU trade mark registered in the name of an agent or representative Where an EU trade mark is registered in the name of the agent or representative of a person who is the proprietor of that trade mark, without the proprietor's authorisation, the latter shall be entitled to oppose the use of his mark by his agent or representative if he has not authorised such use, unless the agent or representative justifies his action. Article 14 Limitation of the effects of an EU trade mark 1. An EU trade mark shall not entitle the proprietor to prohibit a third party from using, in the course of trade: (a) the name or address of the third party, where that third party is a natural person; (b) signs or indications which are not distinctive or which concern the kind, quality, quantity, intended purpose, value, geographical origin, the time of production of goods or of rendering of the service, or other characteristics of the goods or services; (c) the EU trade mark for the purpose of identifying or referring to goods or services as those of the proprietor of that trade mark, in particular, where the use of that trade mark is necessary to indicate the intended purpose of a product or service, in particular as accessories or spare parts. 2. Paragraph 1 shall only apply where the use made by the third party is in accordance with honest practices in industrial or commercial matters. Article 15 Exhaustion of the rights conferred by an EU trade mark 1. An EU trade mark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the European Economic Area under that trade mark by the proprietor or with his consent. 2. Paragraph 1 shall not apply where there exist legitimate reasons for the proprietor to oppose further commercialisation of the goods, especially where the condition of the goods is changed or impaired after they have been put on the market. Article 16 Intervening right of the proprietor of a later registered trade mark as a defence in infringement proceedings 1. In infringement proceedings, the proprietor of an EU trade mark shall not be entitled to prohibit the use of a later registered EU trade mark where that later trade mark would not be declared invalid pursuant to Article 60(1), (3) or (4), Article 61(1) or (2), or Article 64(2) of this Regulation. 2. In infringement proceedings, the proprietor of an EU trade mark shall not be entitled to prohibit the use of a later registered national trade mark where that later registered national trade mark would not be declared invalid pursuant to Article 8 or Article 9(1) or (2), or Article 46(3) of Directive (EU) 2015/2436 of the European Parliament and of the Council (12). 3. Where the proprietor of an EU trade mark is not entitled to prohibit the use of a later registered trade mark pursuant to paragraph 1 or 2, the proprietor of that later registered trade mark shall not be entitled to prohibit the use of that earlier EU trade mark in infringement proceedings. Article 17 Complementary application of national law relating to infringement 1. The effects of EU trade marks shall be governed solely by the provisions of this Regulation. In other respects, infringement of an EU trade mark shall be governed by the national law relating to infringement of a national trade mark in accordance with the provisions of Chapter X. 2. This Regulation shall not prevent actions concerning an EU trade mark being brought under the law of Member States relating in particular to civil liability and unfair competition. 3. The rules of procedure to be applied shall be determined in accordance with the provisions of Chapter X. SECTION 3 Use of an EU trade mark Article 18 Use of an EU trade mark 1. If, within a period of five years following registration, the proprietor has not put the EU trade mark to genuine use in the Union in connection with the goods or services in respect of which it is registered, or if such use has been suspended during an uninterrupted period of five years, the EU trade mark shall be subject to the sanctions provided for in this Regulation, unless there are proper reasons for non-use. The following shall also constitute use within the meaning of the first subparagraph: (a) use of the EU trade mark in a form differing in elements which do not alter the distinctive character of the mark in the form in which it was registered, regardless of whether or not the trade mark in the form as used is also registered in the name of the proprietor; (b) affixing of the EU trade mark to goods or to the packaging thereof in the Union solely for export purposes. 2. Use of the EU trade mark with the consent of the proprietor shall be deemed to constitute use by the proprietor. SECTION 4 EU trade marks as objects of property Article 19 Dealing with EU trade marks as national trade marks 1. Unless Articles 20 to 28 provide otherwise, an EU trade mark as an object of property shall be dealt with in its entirety, and for the whole area of the Union, as a national trade mark registered in the Member State in which, according to the Register: (a) the proprietor has his seat or his domicile on the relevant date; (b) where point (a) does not apply, the proprietor has an establishment on the relevant date. 2. In cases which are not provided for by paragraph 1, the Member State referred to in that paragraph shall be the Member State in which the seat of the Office is situated. 3. If two or more persons are mentioned in the Register as joint proprietors, paragraph 1 shall apply to the joint proprietor first mentioned; failing this, it shall apply to the subsequent joint proprietors in the order in which they are mentioned. Where paragraph 1 does not apply to any of the joint proprietors, paragraph 2 shall apply. Article 20 Transfer 1. An EU trade mark may be transferred, separately from any transfer of the undertaking, in respect of some or all of the goods or services for which it is registered. 2. A transfer of the whole of the undertaking shall include the transfer of the EU trade mark except where, in accordance with the law governing the transfer, there is agreement to the contrary or circumstances clearly dictate otherwise. This provision shall apply to the contractual obligation to transfer the undertaking. 3. Without prejudice to paragraph 2, an assignment of the EU trade mark shall be made in writing and shall require the signature of the parties to the contract, except when it is a result of a judgment; otherwise it shall be void. 4. On request of one of the parties a transfer shall be entered in the Register and published. 5. An application for registration of a transfer shall contain information to identify the EU trade mark, the new proprietor, the goods and services to which the transfer relates, as well as documents duly establishing the transfer in accordance with paragraphs 2 and 3. The application may further contain, where applicable, information to identify the representative of the new proprietor. 6. The Commission shall adopt implementing acts specifying: (a) the details to be contained in the application for registration of a transfer; (b) the kind of documentation required to establish a transfer, taking account of the agreements given by the registered proprietor and the successor in title; (c) the details of how to process applications for partial transfers, ensuring that the goods and services in the remaining registration and the new registration do not overlap and that a separate file, including a new registration number, is established for the new registration. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). 7. Where the conditions applicable to the registration of a transfer, as laid down in paragraphs 1, 2 and 3, or in the implementing acts referred to in paragraph 6, are not fulfilled, the Office shall notify the applicant of the deficiencies. If the deficiencies are not remedied within a period to be specified by the Office, it shall reject the application for registration of the transfer. 8. A single application for registration of a transfer may be submitted for two or more trade marks, provided that the registered proprietor and the successor in title are the same in each case. 9. Paragraphs 5 to 8 shall also apply to applications for EU trade marks. 10. In the case of a partial transfer, any application made by the original proprietor pending with regard to the original registration shall be deemed to be pending with regard to the remaining registration and the new registration. Where such application is subject to the payment of fees and those fees have been paid by the original proprietor, the new proprietor shall not be liable to pay any additional fees with regard to such application. 11. As long as the transfer has not been entered in the Register, the successor in title may not invoke the rights arising from the registration of the EU trade mark. 12. Where there are time limits to be observed vis-à-vis the Office, the successor in title may make the corresponding statements to the Office once the request for registration of the transfer has been received by the Office. 13. All documents which require notification to the proprietor of the EU trade mark in accordance with Article 98 shall be addressed to the person registered as proprietor. Article 21 Transfer of a trade mark registered in the name of an agent 1. Where an EU trade mark is registered in the name of the agent or representative of a person who is the proprietor of that trade mark, without the proprietor's authorisation, the latter shall be entitled to demand the assignment of the EU trade mark in his favour, unless such agent or representative justifies his action. 2. The proprietor may submit a request for assignment pursuant to paragraph 1 of this Article to the following: (a) the Office, pursuant to Article 60(1)(b), instead of an application for a declaration of invalidity; (b) a European Union trade mark court (‘EU trade mark court’) as referred to in Article 123, instead of a counterclaim for a declaration of invalidity based on Article 128(1). Article 22 Rights in rem 1. An EU trade mark may, independently of the undertaking, be given as security or be the subject of rights in rem. 2. At the request of one of the parties, the rights referred to in paragraph 1 or the transfer of those rights shall be entered in the Register and published. 3. An entry in the Register effected pursuant to paragraph 2 shall be cancelled or modified at the request of one of the parties. Article 23 Levy of execution 1. An EU trade mark may be levied in execution. 2. As regards the procedure for levy of execution in respect of an EU trade mark, the courts and authorities of the Member States determined in accordance with Article 19 shall have exclusive jurisdiction. 3. On request of one the parties, the levy of execution shall be entered in the Register and published. 4. An entry in the Register effected pursuant to paragraph 3 shall be cancelled or modified at the request of one of the parties. Article 24 Insolvency proceedings 1. The only insolvency proceedings in which an EU trade mark may be involved are those opened in the Member State in the territory of which the debtor has his centre of main interests. However, where the debtor is an insurance undertaking or a credit institution as defined in Directive 2009/138/EC of the European Parliament and of the Council (13) and Directive 2001/24/EC of the European Parliament and of the Council (14), respectively, the only insolvency proceedings in which an EU trade mark may be involved are those opened in the Member State where that undertaking or institution has been authorised. 2. In the case of joint proprietorship of an EU trade mark, paragraph 1 shall apply to the share of the joint proprietor. 3. Where an EU trade mark is involved in insolvency proceedings, on request of the competent national authority an entry to this effect shall be made in the Register and published in the European Union Trade Marks Bulletin referred to in Article 116. Article 25 Licensing 1. An EU trade mark may be licensed for some or all of the goods or services for which it is registered and for the whole or part of the Union. A licence may be exclusive or non-exclusive. 2. The proprietor of an EU trade mark may invoke the rights conferred by that trade mark against a licensee who contravenes any provision in his licensing contract with regard to: (a) its duration; (b) the form covered by the registration in which the trade mark may be used; (c) the scope of the goods or services for which the licence is granted; (d) the territory in which the trade mark may be affixed; or (e) the quality of the goods manufactured or of the services provided by the licensee. 3. Without prejudice to the provisions of the licensing contract, the licensee may bring proceedings for infringement of an EU trade mark only if its proprietor consents thereto. However, the holder of an exclusive licence may bring such proceedings if the proprietor of the trade mark, after formal notice, does not himself bring infringement proceedings within an appropriate period. 4. A licensee shall, for the purpose of obtaining compensation for damage suffered by him, be entitled to intervene in infringement proceedings brought by the proprietor of the EU trade mark. 5. On request of one of the parties the grant or transfer of a licence in respect of an EU trade mark shall be entered in the Register and published. 6. An entry in the Register effected pursuant to paragraph 5 shall be cancelled or modified at the request of one of the parties. Article 26 Procedure for entering licences and other rights in the Register 1. Article 20(5) and (6) and the rules adopted pursuant to it and Article 20(8) shall apply mutatis mutandis to the registration of a right in rem or transfer of a right in rem as referred to in Article 22(2), the levy of execution as referred to in Article 23(3), the involvement in insolvency proceedings as referred to in Article 24(3), as well as to the registration of a licence or transfer of a licence as referred to in Article 25(5), subject to the following: (a) the requirement relating to the identification of goods and services to which the transfer relates shall not apply in respect of a request for registration of a right in rem, of a levy of execution or of insolvency proceedings; (b) the requirement relating to the documents proving the transfer shall not apply where the request is made by the proprietor of the EU trade mark. 2. The application for registration of the rights referred to in paragraph 1 shall not be deemed to have been filed until the required fee has been paid. 3. The application for registration of a licence may contain a request to record a licence in the Register as one or more of the following: (a) an exclusive licence; (b) a sub-licence in the event that the licence is granted by a licensee whose licence is recorded in the Register; (c) a licence limited to only part of the goods or services for which the mark is registered; (d) a licence limited to part of the Union; (e) a temporary licence. Where a request is made to record the licence as a licence listed in points (c), (d) and (e) of the first subparagraph, the application for registration of a licence shall indicate the goods and services, the part of the Union and the time period for which the licence is granted. 4. Where the conditions applicable to registration, as laid down in Articles 22 to 25, in paragraphs 1 and 3 of this Article and in the other applicable rules adopted pursuant to this Regulation, are not fulfilled, the Office shall notify the applicant of the deficiency. If the deficiency is not corrected within a period specified by the Office, it shall reject the application for registration. 5. Paragraphs 1 and 3 shall apply mutatis mutandis to applications for EU trade marks. Article 27 Effects vis-à-vis third parties 1. Legal acts referred to in Articles 20, 22 and 25 concerning an EU trade mark shall have effects vis-à-vis third parties in all the Member States only after entry in the Register. Nevertheless, such an act, before it is so entered, shall have effect vis-à-vis third parties who have acquired rights in the trade mark after the date of that act but who knew of the act at the date on which the rights were acquired. 2. Paragraph 1 shall not apply in the case of a person who acquires the EU trade mark or a right concerning the EU trade mark by way of transfer of the whole of the undertaking or by any other universal succession. 3. The effects vis-à-vis third parties of the legal acts referred to in Article 23 shall be governed by the law of the Member State determined in accordance with Article 19. 4. Until such time as common rules for the Member States in the field of bankruptcy enter into force, the effects vis-à-vis third parties of bankruptcy or similar proceedings shall be governed by the law of the Member State in which such proceedings are first brought within the meaning of national law or of conventions applicable in this field. Article 28 The application for an EU trade mark as an object of property Articles 19 to 27 shall apply to applications for EU trade marks. Article 29 Procedure for cancelling or modifying the entry in the Register of licences and other rights 1. A registration effected under Article 26(1) shall be cancelled or modified at the request of one of the persons concerned. 2. The application shall contain the registration number of the EU trade mark concerned and the particulars of the right for which registration is requested to be cancelled or modified. 3. The application for cancellation of a licence, a right in rem or an enforcement measure shall not be deemed to have been filed until the required fee has been paid. 4. The application shall be accompanied by documents showing that the registered right no longer exists or that the licensee or the holder of another right consents to the cancellation or modification of the registration. 5. Where the requirements for cancellation or modification of the registration are not satisfied, the Office shall notify the applicant of the deficiency. If the deficiency is not corrected within a period to be specified by the Office, it shall reject the application for cancellation or modification of the registration. 6. Paragraphs 1 to 5 of this Article shall apply mutatis mutandis to entries made in the files pursuant to Article 26(5). CHAPTER III APPLICATION FOR EU TRADE MARKS SECTION 1 Filing of applications and the conditions which govern them Article 30 Filing of applications 1. An application for an EU trade mark shall be filed at the Office. 2. The Office shall issue to the applicant, without delay, a receipt which shall include at least the file number, a representation, description or other identification of the mark, the nature and the number of the documents and the date of their receipt. That receipt may be issued by electronic means. Article 31 Conditions with which applications must comply 1. An application for an EU trade mark shall contain: (a) a request for the registration of an EU trade mark; (b) information identifying the applicant; (c) a list of the goods or services in respect of which the registration is requested; (d) a representation of the mark, which satisfies the requirements set out in Article 4(b). 2. The application for an EU trade mark shall be subject to the payment of the application fee covering one class of goods or services and, where appropriate, of one or more class fees for each class of goods and services exceeding the first class and, where applicable, the search fee. 3. In addition to the requirements referred to in paragraphs 1 and 2, an application for an EU trade mark shall comply with the formal requirements laid down in this Regulation and in the implementing acts adopted pursuant to it. If those conditions provide for the trade mark to be represented electronically, the Executive Director may determine the formats and maximum size of such an electronic file. 4. The Commission shall adopt implementing acts specifying the details to be contained in the application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 32 Date of filing The date of filing of an EU trade mark application shall be the date on which the documents containing the information specified in Article 31(1) are filed with the Office by the applicant, subject to payment of the application fee within one month of filing those documents. Article 33 Designation and classification of goods and services 1. Goods and services in respect of which trade mark registration is applied for shall be classified in conformity with the system of classification established by the Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks of 15 June 1957 (‘the Nice Classification’). 2. The goods and services for which the protection of the trade mark is sought shall be identified by the applicant with sufficient clarity and precision to enable the competent authorities and economic operators, on that sole basis, to determine the extent of the protection sought. 3. For the purposes of paragraph 2, the general indications included in the class headings of the Nice Classification or other general terms may be used, provided that they comply with the requisite standards of clarity and precision set out in this Article. 4. The Office shall reject an application in respect of indications or terms which are unclear or imprecise, where the applicant does not suggest an acceptable wording within a period set by the Office to that effect. 5. The use of general terms, including the general indications of the class headings of the Nice Classification, shall be interpreted as including all the goods or services clearly covered by the literal meaning of the indication or term. The use of such terms or indications shall not be interpreted as comprising a claim to goods or services which cannot be so understood. 6. Where the applicant requests registration for more than one class, the applicant shall group the goods and services according to the classes of the Nice Classification, each group being preceded by the number of the class to which that group of goods or services belongs, and shall present them in the order of the classes. 7. Goods and services shall not be regarded as being similar to each other on the ground that they appear in the same class under the Nice Classification. Goods and services shall not be regarded as being dissimilar from each other on the ground that they appear in different classes under the Nice Classification. 8. Proprietors of EU trade marks applied for before 22 June 2012 which are registered in respect of the entire heading of a Nice class may declare that their intention on the date of filing had been to seek protection in respect of goods or services beyond those covered by the literal meaning of the heading of that class, provided that the goods or services so designated are included in the alphabetical list for that class in the edition of the Nice Classification in force at the date of filing. The declaration shall be filed at the Office by 24 September 2016, and shall indicate, in a clear, precise and specific manner, the goods and services, other than those clearly covered by the literal meaning of the indications of the class heading, originally covered by the proprietor's intention. The Office shall take appropriate measures to amend the Register accordingly. The possibility to make a declaration in accordance with the first subparagraph of this paragraph shall be without prejudice to the application of Article 18, Article 47(2), Article 58(1)(a), and Article 64(2). EU trade marks for which no declaration is filed within the period referred to in the second subparagraph shall be deemed to extend, as from the expiry of that period, only to goods or services clearly covered by the literal meaning of the indications included in the heading of the relevant class. 9. Where the register is amended, the exclusive rights conferred by the EU trade mark under Article 9 shall not prevent a third party from continuing to use a trade mark in relation to goods or services where and to the extent that the use of the trade mark for those goods or services: (a) commenced before the register was amended; and (b) did not infringe the proprietor's rights based on the literal meaning of the record of the goods and services in the register at that time. In addition, the amendment of the list of goods or services recorded in the register shall not give the proprietor of the EU trade mark the right to oppose or to apply for a declaration of invalidity of a later trade mark where and to the extent that: (a) the later trade mark was either in use, or an application had been made to register the trade mark, for goods or services before the register was amended; and (b) the use of the trade mark in relation to those goods or services did not infringe, or would not have infringed, the proprietor's rights based on the literal meaning of the record of the goods and services in the register at that time. SECTION 2 Priority Article 34 Right of priority 1. A person who has duly filed an application for a trade mark in or in respect of any State party to the Paris Convention or to the Agreement establishing the World Trade Organisation, or his successors in title, shall enjoy, for the purpose of filing an EU trade mark application for the same trade mark in respect of goods or services which are identical with or contained within those for which the application has been filed, a right of priority during a period of six months from the date of filing of the first application. 2. Every filing that is equivalent to a regular national filing under the national law of the State where it was made or under bilateral or multilateral agreements shall be recognised as giving rise to a right of priority. 3. By a regular national filing is meant any filing that is sufficient to establish the date on which the application was filed, whatever may be the outcome of the application. 4. A subsequent application for a trade mark which was the subject of a previous first application in respect of the same goods or services and which is filed in or in respect of the same State shall be considered as the first application for the purposes of determining priority, provided that, at the date of filing of the subsequent application, the previous application has been withdrawn, abandoned or refused, without being open to public inspection and without leaving any rights outstanding, and has not served as a basis for claiming a right of priority. The previous application may not thereafter serve as a basis for claiming a right of priority. 5. If the first filing has been made in a State which is not a party to the Paris Convention or to the Agreement establishing the World Trade Organisation, paragraphs 1 to 4 shall apply only in so far as that State, according to published findings, grants, on the basis of the first filing made at the Office and subject to conditions equivalent to those laid down in this Regulation, a right of priority having equivalent effect. The Executive Director shall, where necessary, request the Commission to consider enquiring as to whether a State within the meaning of the first sentence accords that reciprocal treatment. If the Commission determines that reciprocal treatment in accordance with the first sentence is accorded, it shall publish a communication to that effect in the Official Journal of the European Union. 6. Paragraph 5 shall apply from the date of publication in the Official Journal of the European Union of the communication determining that reciprocal treatment is accorded, unless the communication states an earlier date from which it is applicable. It shall cease to apply from the date of publication in the Official Journal of the European Union of a communication of the Commission to the effect that reciprocal treatment is no longer accorded, unless the communication states an earlier date from which it is applicable. 7. Communications as referred to in paragraphs 5 and 6 shall also be published in the Official Journal of the Office. Article 35 Claiming priority 1. Priority claims shall be filed together with the EU trade mark application and shall include the date, number and country of the previous application. The documentation in support of priority claims shall be filed within three months of the filing date. 2. The Commission shall adopt implementing acts specifying the kind of documentation to be filed for claiming the priority of a previous application in accordance with paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). 3. The Executive Director may determine that the documentation to be provided by the applicant in support of the priority claim may consist of less than what is required under the specifications adopted in accordance with paragraph 2, provided that the information required is available to the Office from other sources. Article 36 Effect of priority right The right of priority shall have the effect that the date of priority shall count as the date of filing of the EU trade mark application for the purposes of establishing which rights take precedence. Article 37 Equivalence of Union filing with national filing An EU trade mark application which has been accorded a date of filing shall, in the Member States, be equivalent to a regular national filing, where appropriate with the priority claimed for the EU trade mark application. SECTION 3 Exhibition priority Article 38 Exhibition priority 1. If an applicant for an EU trade mark has displayed goods or services under the mark applied for, at an official or officially recognised international exhibition falling within the terms of the Convention relating to international exhibitions signed at Paris on 22 November 1928 and last revised on 30 November 1972, he may, if he files the application within a period of six months of the date of the first display of the goods or services under the mark applied for, claim a right of priority from that date within the meaning of Article 36. The priority claim shall be filed together with the EU trade mark application. 2. An applicant who wishes to claim priority pursuant to paragraph 1 shall file evidence of the display of goods or services under the mark applied for within three months of the filing date. 3. An exhibition priority granted in a Member State or in a third country shall not extend the period of priority laid down in Article 34. 4. The Commission shall adopt implementing acts specifying the type and details of evidence to be filed for claiming an exhibition priority in accordance with paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). SECTION 4 Seniority of a national trade mark Article 39 Claiming seniority of a national trade mark in an application for an EU trade mark or subsequent to the filing of the application 1. The proprietor of an earlier trade mark registered in a Member State, including a trade mark registered in the Benelux countries, or registered under international arrangements having effect in a Member State, who applies for an identical trade mark for registration as an EU trade mark for goods or services which are identical with or contained within those for which the earlier trade mark has been registered, may claim for the EU trade mark the seniority of the earlier trade mark in respect of the Member State in or for which it is registered. 2. Seniority claims shall either be filed together with the EU trade mark application or within two months of the filing date of the application, and shall include the Member State or Member States in or for which the mark is registered, the number and the filing date of the relevant registration, and the goods and services for which the mark is registered. Where the seniority of one or more registered earlier trade marks is claimed in the application, the documentation in support of the seniority claim shall be filed within three months of the filing date. Where the applicant wishes to claim the seniority subsequent to the filing of the application, the documentation in support of the seniority claim shall be submitted to the Office within three months of receipt of the seniority claim. 3. Seniority shall have the sole effect under this Regulation that, where the proprietor of the EU trade mark surrenders the earlier trade mark or allows it to lapse, he shall be deemed to continue to have the same rights as he would have had if the earlier trade mark had continued to be registered. 4. The seniority claimed for the EU trade mark shall lapse where the earlier trade mark the seniority of which is claimed is declared to be invalid or revoked. Where the earlier trade mark is revoked, the seniority shall lapse provided that the revocation takes effect prior to the filing date or priority date of that EU trade mark. 5. The Office shall inform the Benelux Office for Intellectual Property or the central industrial property office of the Member State concerned of the effective claiming of seniority. 6. The Commission shall adopt implementing acts specifying the kind of documentation to be filed for claiming the seniority of a national trade mark or a trade mark registered under international agreements having effect in a Member State in accordance with paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). 7. The Executive Director may determine that the documentation to be provided by the applicant in support of the seniority claim may consist of less than what is required under the specifications adopted in accordance with paragraph 6, provided that the information required is available to the Office from other sources. Article 40 Claiming seniority of a national trade mark after registration of an EU trade mark 1. The proprietor of an EU trade mark who is the proprietor of an earlier identical trade mark registered in a Member State, including a trade mark registered in the Benelux countries or of an earlier identical trade mark, with an international registration effective in a Member State, for goods or services which are identical to those for which the earlier trade mark has been registered, or contained within them, may claim the seniority of the earlier trade mark in respect of the Member State in or for which it was registered. 2. Seniority claims filed pursuant to paragraph 1 of this Article shall include the registration number of the EU trade mark, the name and address of its proprietor, the Member State or Member States in or for which the earlier mark is registered, the number and the filing date of the relevant registration, the goods and services for which the mark is registered and those in respect of which seniority is claimed, and supporting documentation as provided for in the rules adopted pursuant to Article 39(6). 3. If the requirements governing the claiming of seniority are not fulfilled, the Office shall communicate the deficiency to the proprietor of the EU trade mark. If the deficiency is not remedied within a period to be specified by the Office, the Office shall reject the claim. 4. Article 39(3), (4), (5) and (7) shall apply. CHAPTER IV REGISTRATION PROCEDURE SECTION 1 Examination of applications Article 41 Examination of the conditions of filing 1. The Office shall examine whether: (a) the EU trade mark application satisfies the requirements for the accordance of a date of filing in accordance with Article 32; (b) the EU trade mark application complies with the conditions and requirements referred to in Article 31(3); (c) where appropriate, the class fees have been paid within the prescribed period. 2. Where the EU trade mark application does not satisfy the requirements referred to in paragraph 1, the Office shall request the applicant to remedy the deficiencies or the default on payment within two months of the receipt of the notification. 3. If the deficiencies or the default on payment established pursuant to paragraph 1(a) are not remedied within this period, the application shall not be dealt with as an EU trade mark application. If the applicant complies with the Office's request, the Office shall accord as the date of filing of the application the date on which the deficiencies or the default on payment established are remedied. 4. If the deficiencies established pursuant to paragraph 1(b) are not remedied within the prescribed period, the Office shall refuse the application. 5. If the default on payment established pursuant to paragraph 1(c) is not remedied within the prescribed period, the application shall be deemed to be withdrawn unless it is clear which categories of goods or services the amount paid is intended to cover. In the absence of other criteria to determine which classes are intended to be covered, the Office shall take the classes in the order of the classification. The application shall be deemed to have been withdrawn with regard to those classes for which the class fees have not been paid or have not been paid in full. 6. Failure to satisfy the requirements concerning the claim to priority shall result in loss of the right of priority for the application. 7. Failure to satisfy the requirements concerning the claiming of seniority of a national trade mark shall result in loss of that right for the application. 8. Where failure to satisfy the requirements referred to in paragraph 1(b) and (c) concerns only some of the goods or services, the Office shall refuse the application, or the right of priority or the right of seniority shall be lost, only in so far as those goods and services are concerned. Article 42 Examination as to absolute grounds for refusal 1. Where, under Article 7, a trade mark is ineligible for registration in respect of some or all of the goods or services covered by the EU trade mark application, the application shall be refused as regards those goods or services. 2. The application shall not be refused before the applicant has been allowed the opportunity to withdraw or amend the application or to submit his observations. To this effect, the Office shall notify the applicant of the grounds for refusing registration and shall specify a period within which he may withdraw or amend the application or submit his observations. Where the applicant fails to overcome the grounds for refusing registration, the Office shall refuse registration in whole or in part. SECTION 2 Search Article 43 Search report 1. The Office shall, at the request of the applicant for the EU trade mark when filing the application, draw up a European Union search report (‘EU search report’) citing those earlier EU trade marks or EU trade mark applications discovered which may be invoked under Article 8 against the registration of the EU trade mark applied for. 2. Where, at the time of filing an EU trade mark application, the applicant requests that a search report be prepared by the central industrial property offices of the Member States and where the appropriate search fee has been paid within the time limit for the payment of the filing fee, the Office shall transmit without delay a copy of the EU trade mark application to the central industrial property office of each Member State which has informed the Office of its decision to operate a search in its own register of trade marks in respect of EU trade mark applications. 3. Each of the central industrial property offices of the Member States referred to in paragraph 2 shall communicate a search report which shall either cite any earlier national trade marks, national trade mark applications or trade marks registered under international agreements, having effect in the Member State or Member States concerned, which have been discovered and which may be invoked under Article 8 against the registration of the EU trade mark applied for, or state that the search has revealed no such rights. 4. The Office, after consulting the Management Board provided for in Article 153 (‘the Management Board’), shall establish the contents and modalities for the reports. 5. The Office shall pay an amount to each central industrial property office for each search report provided in accordance with paragraph 3. The amount, which shall be the same for each office, shall be fixed by the Budget Committee by means of a decision adopted by a majority of three quarters of the representatives of the Member States. 6. The Office shall transmit to the applicant for the EU trade mark the EU search report requested and any requested national search reports received. 7. Upon publication of the EU trade mark application, the Office shall inform the proprietors of any earlier EU trade marks or EU trade mark applications cited in the EU search report of the publication of the EU trade mark application. The latter shall apply irrespective of whether the applicant has requested to receive the EU search report, unless the proprietor of an earlier registration or application requests not to receive the notification. SECTION 3 Publication of the application Article 44 Publication of the application 1. If the conditions which the application for an EU trade mark is required to satisfy have been fulfilled, the application shall be published for the purposes of Article 46 to the extent that it has not been refused pursuant to Article 42. The publication of the application shall be without prejudice to information already made available to the public otherwise in accordance with this Regulation or acts adopted pursuant to this Regulation. 2. Where, after publication, the application is refused pursuant to Article 42, the decision that it has been refused shall be published upon becoming final. 3. Where the publication of the application contains an error attributable to the Office, the Office shall of its own motion or at the request of the applicant correct the error and publish the correction. The rules adopted pursuant to Article 49(3) shall apply mutatis mutandis where a correction is requested by the applicant. 4. Article 46(2) shall also apply where the correction concerns the list of goods or services or the representation of the mark. 5. The Commission shall adopt implementing acts laying down the details to be contained in the publication of the application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). SECTION 4 Observations by third parties and opposition Article 45 Observations by third parties 1. Any natural or legal person and any group or body representing manufacturers, producers, suppliers of services, traders or consumers may submit to the Office written observations, explaining on which grounds, under Articles 5 and 7, the trade mark should not be registered ex officio. Persons and groups or bodies as referred to in the first subparagraph shall not be parties to the proceedings before the Office. 2. Third party observations shall be submitted before the end of the opposition period or, where an opposition against the trade mark has been filed, before the final decision on the opposition is taken. 3. The submission referred to in paragraph 1 shall be without prejudice to the right of the Office to re-open the examination of absolute grounds on its own initiative at any time before registration, where appropriate. 4. The observations referred to in paragraph 1 shall be communicated to the applicant who may comment on them. Article 46 Opposition 1. Within a period of three months following the publication of an EU trade mark application, notice of opposition to registration of the trade mark may be given on the grounds that it may not be registered under Article 8: (a) by the proprietors of earlier trade marks referred to in Article 8(2) as well as licensees authorised by the proprietors of those trade marks, in respect of Article 8(1) and (5); (b) by the proprietors of trade marks referred to in Article 8(3); (c) by the proprietors of earlier marks or signs referred to in Article 8(4) and by persons authorised under the relevant national law to exercise these rights; (d) by the persons authorised under the relevant Union legislation or national law to exercise the rights referred to in Article 8(6). 2. Notice of opposition to registration of the trade mark may also be given, subject to the conditions laid down in paragraph 1, in the event of the publication of an amended application in accordance with the second sentence of Article 49(2). 3. Opposition shall be expressed in writing, and shall specify the grounds on which it is made. It shall not be considered as duly entered until the opposition fee has been paid. 4. Within a period to be fixed by the Office, the opponent may submit facts, evidence and arguments in support of his case. Article 47 Examination of opposition 1. In the examination of the opposition the Office shall invite the parties, as often as necessary, to file observations, within a period set by the Office, on communications from the other parties or issued by itself. 2. If the applicant so requests, the proprietor of an earlier EU trade mark who has given notice of opposition shall furnish proof that, during the five-year period preceding the date of filing or the date of priority of the EU trade mark application, the earlier EU trade mark has been put to genuine use in the Union in connection with the goods or services in respect of which it is registered and which he cites as justification for his opposition, or that there are proper reasons for non-use, provided that the earlier EU trade mark has at that date been registered for not less than five years. In the absence of proof to this effect, the opposition shall be rejected. If the earlier EU trade mark has been used in relation to only part of the goods or services for which it is registered it shall, for the purposes of the examination of the opposition, be deemed to be registered in respect only of that part of the goods or services. 3. Paragraph 2 shall apply to earlier national trade marks referred to in Article 8(2)(a), by substituting use in the Member State in which the earlier national trade mark is protected for use in the Union. 4. The Office may, if it thinks fit, invite the parties to make a friendly settlement. 5. If examination of the opposition reveals that the trade mark may not be registered in respect of some or all of the goods or services for which the EU trade mark application has been made, the application shall be refused in respect of those goods or services. Otherwise the opposition shall be rejected. 6. The decision refusing the application shall be published upon becoming final. Article 48 Delegation of powers The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the details of the procedure for filing and examining an opposition set out in Articles 46 and 47. SECTION 5 Withdrawal, restriction, amendment and division of the application Article 49 Withdrawal, restriction and amendment of the application 1. The applicant may at any time withdraw his EU trade mark application or restrict the list of goods or services contained therein. Where the application has already been published, the withdrawal or restriction shall also be published. 2. In other respects, an EU trade mark application may be amended, upon request of the applicant, only by correcting the name and address of the applicant, errors of wording or of copying, or obvious mistakes, provided that such correction does not substantially change the trade mark or extend the list of goods or services. Where the amendments affect the representation of the trade mark or the list of goods or services and are made after publication of the application, the trade mark application shall be published as amended. 3. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the details of the procedure governing the amendment of the application. Article 50 Division of the application 1. The applicant may divide the application by declaring that some of the goods or services included in the original application will be the subject of one or more divisional applications. The goods or services in the divisional application shall not overlap with the goods or services which remain in the original application or those which are included in other divisional applications. 2. The declaration of division shall not be admissible: (a) if, where an opposition has been entered against the original application, such a divisional application has the effect of introducing a division amongst the goods or services against which the opposition has been directed, until the decision of the Opposition Division has become final or the opposition proceedings are finally terminated otherwise; (b) before the date of filing referred to in Article 32 has been accorded by the Office and during the opposition period provided for in Article 46(1). 3. The declaration of division shall be subject to a fee. The declaration shall be deemed not to have been made until the fee has been paid. 4. Where the Office finds that the requirements laid down in paragraph 1 and in the rules adopted pursuant to paragraph 9(a) are not fulfilled, it shall invite the applicant to remedy the deficiencies within a period to be specified by the Office. If the deficiencies are not remedied before the time limit expires, the Office shall refuse the declaration of division. 5. The division shall take effect on the date on which it is recorded in the files kept by the Office concerning the original application. 6. All requests and applications submitted and all fees paid with regard to the original application prior to the date on which the Office receives the declaration of division are deemed also to have been submitted or paid with regard to the divisional application or applications. The fees for the original application which have been duly paid prior to the date on which the declaration of division is received shall not be refunded. 7. The divisional application shall preserve the filing date and any priority date and seniority date of the original application. 8. Where the declaration of division relates to an application which has already been published pursuant to Article 44, the division shall be published. The divisional application shall be published. The publication shall not open a new period for the filing of oppositions. 9. The Commission shall adopt implementing acts specifying: (a) the details to be contained in a declaration of the division of an application made pursuant to paragraph 1; (b) the details as to how to process a declaration of the division of an application, ensuring that a separate file, including a new application number, is established for the divisional application; (c) the details to be contained in the publication of the divisional application pursuant to paragraph 8. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). SECTION 6 Registration Article 51 Registration 1. Where an application meets the requirements set out in this Regulation and where no notice of opposition has been given within the period referred to in Article 46(1) or where any opposition entered has been finally disposed of by withdrawal, rejection or other disposition, the trade mark and the particulars referred to in Article 111(2) shall be recorded in the Register. The registration shall be published. 2. The Office shall issue a certificate of registration. That certificate may be issued by electronic means. The Office shall provide certified or uncertified copies of the certificate subject to the payment of a fee, where those copies are issued other than by electronic means. 3. The Commission shall adopt implementing acts specifying the details to be contained in and the form of the certificate of registration referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). CHAPTER V DURATION, RENEWAL, ALTERATION AND DIVISION OF EU TRADE MARKS Article 52 Duration of registration EU trade marks shall be registered for a period of 10 years from the date of filing of the application. Registration may be renewed in accordance with Article 53 for further periods of 10 years. Article 53 Renewal 1. Registration of the EU trade mark shall be renewed at the request of the proprietor of the EU trade mark or any person expressly authorised by him, provided that the fees have been paid. 2. The Office shall inform the proprietor of the EU trade mark, and any person having a registered right in respect of the EU trade mark, of the expiry of the registration at least six months before the said expiry. Failure to give such information shall not involve the responsibility of the Office and shall not affect the expiry of the registration. 3. The request for renewal shall be submitted in the six-month period prior to the expiry of the registration. The basic fee for the renewal and, where appropriate, one or more class fees for each class of goods or services exceeding the first one shall also be paid within this period. Failing this, the request may be submitted and the fees paid within a further period of six months following the expiry of registration, provided that an additional fee for late payment of the renewal fee or late submission of the request for renewal is paid within this further period. 4. The request for renewal shall include: (a) the name of the person requesting renewal; (b) the registration number of the EU trade mark to be renewed; (c) if the renewal is requested for only part of the registered goods and services, an indication of those classes or those goods and services for which renewal is requested, or those classes or those goods and services for which renewal is not requested, grouped according to the classes of the Nice classification, each group being preceded by the number of the class of that classification to which that group of goods or services belongs, and presented in the order of classes of that classification. If the payment referred to in paragraph 3 is made, it shall be deemed to constitute a request for renewal provided that it contains all necessary indications to establish the purpose of the payment. 5. Where the request is submitted or the fees paid in respect of only some of the goods or services for which the EU trade mark is registered, registration shall be renewed for those goods or services only. Where the fees paid are insufficient to cover all the classes of goods and services for which renewal is requested, registration shall be renewed if it is clear which class or classes are to be covered. In the absence of other criteria, the Office shall take the classes into account in the order of classification. 6. Renewal shall take effect from the day following the date on which the existing registration expires. The renewal shall be registered. 7. Where the request for renewal is filed within the periods provided for in paragraph 3, but the other conditions governing renewal provided for in this Article are not satisfied, the Office shall inform the applicant of the deficiencies found. 8. Where a request for renewal is not submitted or is submitted after the expiry of the period provided for in paragraph 3, or where the fees are not paid or are paid only after the period in question has expired, or where the deficiencies referred to in paragraph 7 are not remedied within that period, the Office shall determine that the registration has expired and shall notify the proprietor of the EU trade mark accordingly. Where the determination has become final, the Office shall cancel the mark from the register. The cancellation shall take effect from the day following the date on which the existing registration expired. Where the renewal fees have been paid but the registration is not renewed, those fees shall be refunded. 9. A single request for renewal may be submitted for two or more marks, upon payment of the required fees for each of the marks, provided that the proprietors or the representatives are the same in each case. Article 54 Alteration 1. The EU trade mark shall not be altered in the Register during the period of registration or on renewal thereof. 2. Nevertheless, where the EU trade mark includes the name and address of the proprietor, any alteration thereof not substantially affecting the identity of the trade mark as originally registered may be registered at the request of the proprietor. 3. The request for alteration shall include the element of the mark to be altered and that element in its altered version. The Commission shall adopt implementing acts specifying the details to be contained in the request for alteration. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). 4. The request shall be deemed not to have been filed until the required fee has been paid. If the fee has not been paid or has not been paid in full, the Office shall inform the applicant accordingly. A single request may be made for the alteration of the same element in two or more registrations of the same proprietor. The required fee shall be paid in respect of each registration to be altered. If the requirements governing the alteration of the registration are not fulfilled, the Office shall communicate the deficiency to the applicant. If the deficiency is not remedied within a period to be specified by the Office, the Office shall reject the request. 5. The publication of the registration of the alteration shall contain a representation of the EU trade mark as altered. Third parties whose rights may be affected by the alteration may challenge the registration thereof within the period of three months following publication. Articles 46 and 47 and rules adopted pursuant to Article 48 shall apply to the publication of the registration of the alteration. Article 55 Change of the name or address 1. A change of the name or address of the proprietor of the EU trade mark which is not an alteration of the EU trade mark pursuant to Article 54(2) and which is not the consequence of a whole or partial transfer of the EU trade mark shall, at the request of the proprietor, be recorded in the Register. The Commission shall adopt implementing acts specifying the details to be contained in a request for the change of name or address pursuant to the first subparagraph of this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). 2. A single request may be made for the change of the name or address in respect of two or more registrations of the same proprietor. 3. If the requirements governing the recording of a change are not fulfilled, the Office shall communicate the deficiency to the proprietor of the EU trade mark. If the deficiency is not remedied within a period to be specified by the Office, the Office shall reject the request. 4. Paragraphs 1, 2 and 3 shall also apply to a change of the name or address of the registered representative. 5. Paragraphs 1 to 4 shall apply to applications for EU trade marks. The change shall be recorded in the files kept by the Office on the EU trade mark application. Article 56 Division of the registration 1. The proprietor of the EU trade mark may divide the registration by declaring that some of the goods or services included in the original registration will be the subject of one or more divisional registrations. The goods or services in the divisional registration shall not overlap with the goods or services which remain in the original registration or those which are included in other divisional registrations. 2. The declaration of division shall not be admissible: (a) if, where an application for revocation of rights or for a declaration of invalidity has been entered at the Office against the original registration, such a divisional declaration has the effect of introducing a division amongst the goods or services against which the application for revocation of rights or for a declaration of invalidity is directed, until the decision of the Cancellation Division has become final or the proceedings are finally terminated otherwise; (b) if, where a counterclaim for revocation or for a declaration of invalidity has been entered in a case before an EU trade mark court, such a divisional declaration has the effect of introducing a division amongst the goods or services against which the counterclaim is directed, until the mention of the EU trade mark court's judgment is recorded in the Register pursuant to Article 128(6). 3. If the requirements laid down in paragraph 1 and pursuant to the implementing acts referred to in paragraph 8 are not fulfilled, or the list of goods and services which form the divisional registration overlap with the goods and services which remain in the original registration, the Office shall invite the proprietor of the EU trade mark to remedy the deficiencies within such period as it may specify. If the deficiencies are not remedied before the period expires, the Office shall refuse the declaration of division. 4. The declaration of division shall be subject to a fee. The declaration shall be deemed not to have been made until the fee has been paid. 5. The division shall take effect on the date on which it is entered in the Register. 6. All requests and applications submitted and all fees paid with regard to the original registration prior to the date on which the Office receives the declaration of division shall be deemed also to have been submitted or paid with regard to the divisional registration or registrations. The fees for the original registration which have been duly paid prior to the date on which the declaration of division is received shall not be refunded. 7. The divisional registration shall preserve the filing date and any priority date and seniority date of the original registration. 8. The Commission shall adopt implementing acts specifying: (a) the details to be contained in a declaration of the division of a registration pursuant to paragraph 1; (b) the details as how to process a declaration of the division of a registration, ensuring that a separate file, including a new registration number, is established for the divisional registration. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). CHAPTER VI SURRENDER, REVOCATION AND INVALIDITY SECTION 1 Surrender Article 57 Surrender 1. An EU trade mark may be surrendered in respect of some or all of the goods or services for which it is registered. 2. The surrender shall be declared to the Office in writing by the proprietor of the trade mark. It shall not have effect until it has been entered in the Register. The validity of the surrender of an EU trade mark which is declared to the Office subsequent to the submission of an application for revocation of that trade mark pursuant to Article 63(1) shall be conditional upon the final rejection or withdrawal of the application for revocation. 3. Surrender shall be entered only with the agreement of the proprietor of a right relating to the EU trade mark and which is entered in the Register. If a licence has been registered, surrender shall be entered in the Register only if the proprietor of the EU trade mark proves that he has informed the licensee of his intention to surrender. The entry of the surrender shall be made on expiry of the three-month period after the date on which the proprietor satisfies the Office that he has informed the licensee of his intention to surrender, or before the expiry of that period, as soon as he proves that the licensee has given his consent. 4. If the requirements governing surrender are not fulfilled, the Office shall communicate the deficiencies to the declarant. If the deficiencies are not remedied within a period to be specified by the Office, the Office shall reject the entry of surrender in the Register. 5. The Commission shall adopt implementing acts specifying the details to be contained in a declaration of surrender pursuant to paragraph 2 of this Article and the kind of documentation required to establish a third party's agreement pursuant to paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). SECTION 2 Grounds for revocation Article 58 Grounds for revocation 1. The rights of the proprietor of the EU trade mark shall be declared to be revoked on application to the Office or on the basis of a counterclaim in infringement proceedings: (a) if, within a continuous period of five years, the trade mark has not been put to genuine use in the Union in connection with the goods or services in respect of which it is registered, and there are no proper reasons for non-use; however, no person may claim that the proprietor's rights in an EU trade mark should be revoked where, during the interval between expiry of the five-year period and filing of the application or counterclaim, genuine use of the trade mark has been started or resumed; the commencement or resumption of use within a period of three months preceding the filing of the application or counterclaim which began at the earliest on expiry of the continuous period of five years of non-use shall, however, be disregarded where preparations for the commencement or resumption occur only after the proprietor becomes aware that the application or counterclaim may be filed; (b) if, in consequence of acts or inactivity of the proprietor, the trade mark has become the common name in the trade for a product or service in respect of which it is registered; (c) if, in consequence of the use made of the trade mark by the proprietor of the trade mark or with his consent in respect of the goods or services for which it is registered, the trade mark is liable to mislead the public, particularly as to the nature, quality or geographical origin of those goods or services. 2. Where the grounds for revocation of rights exist in respect of only some of the goods or services for which the EU trade mark is registered, the rights of the proprietor shall be declared to be revoked in respect of those goods or services only. SECTION 3 Grounds for invalidity Article 59 Absolute grounds for invalidity 1. An EU trade mark shall be declared invalid on application to the Office or on the basis of a counterclaim in infringement proceedings: (a) where the EU trade mark has been registered contrary to the provisions of Article 7; (b) where the applicant was acting in bad faith when he filed the application for the trade mark. 2. Where the EU trade mark has been registered in breach of the provisions of Article 7(1)(b), (c) or (d), it may nevertheless not be declared invalid if, in consequence of the use which has been made of it, it has after registration acquired a distinctive character in relation to the goods or services for which it is registered. 3. Where the ground for invalidity exists in respect of only some of the goods or services for which the EU trade mark is registered, the trade mark shall be declared invalid as regards those goods or services only. Article 60 Relative grounds for invalidity 1. An EU trade mark shall be declared invalid on application to the Office or on the basis of a counterclaim in infringement proceedings: (a) where there is an earlier trade mark as referred to in Article 8(2) and the conditions set out in paragraph 1 or 5 of that Article are fulfilled; (b) where there is a trade mark as referred to in Article 8(3) and the conditions set out in that paragraph are fulfilled; (c) where there is an earlier right as referred to in Article 8(4) and the conditions set out in that paragraph are fulfilled; (d) where there is an earlier designation of origin or geographical indication as referred to in Article 8(6) and the conditions set out in that paragraph are fulfilled. All the conditions referred to in the first subparagraph shall be fulfilled at the filing date or the priority date of the EU trade mark. 2. An EU trade mark shall also be declared invalid on application to the Office or on the basis of a counterclaim in infringement proceedings where the use of such trade mark may be prohibited pursuant to another earlier right under the Union legislation or national law governing its protection, and in particular: (a) a right to a name; (b) a right of personal portrayal; (c) a copyright; (d) an industrial property right. 3. An EU trade mark may not be declared invalid where the proprietor of a right referred to in paragraph 1 or 2 consents expressly to the registration of the EU trade mark before submission of the application for a declaration of invalidity or the counterclaim. 4. Where the proprietor of one of the rights referred to in paragraph 1 or 2 has previously applied for a declaration that an EU trade mark is invalid or made a counterclaim in infringement proceedings, he may not submit a new application for a declaration of invalidity or lodge a counterclaim on the basis of another of the said rights which he could have invoked in support of his first application or counterclaim. 5. Article 59(3) shall apply. Article 61 Limitation in consequence of acquiescence 1. Where the proprietor of an EU trade mark has acquiesced, for a period of five successive years, in the use of a later EU trade mark in the Union while being aware of such use, he shall no longer be entitled on the basis of the earlier trade mark to apply for a declaration that the later trade mark is invalid in respect of the goods or services for which the later trade mark has been used, unless registration of the later EU trade mark was applied for in bad faith. 2. Where the proprietor of an earlier national trade mark as referred to in Article 8(2) or of another earlier sign referred to in Article 8(4) has acquiesced, for a period of five successive years, in the use of a later EU trade mark in the Member State in which the earlier trade mark or the other earlier sign is protected while being aware of such use, he shall no longer be entitled on the basis of the earlier trade mark or of the other earlier sign to apply for a declaration that the later trade mark is invalid in respect of the goods or services for which the later trade mark has been used, unless registration of the later EU trade mark was applied for in bad faith. 3. In the cases referred to in paragraphs 1 and 2, the proprietor of a later EU trade mark shall not be entitled to oppose the use of the earlier right, even though that right may no longer be invoked against the later EU trade mark. SECTION 4 Consequences of revocation and invalidity Article 62 Consequences of revocation and invalidity 1. The EU trade mark shall be deemed not to have had, as from the date of the application for revocation or of the counterclaim, the effects specified in this Regulation, to the extent that the rights of the proprietor have been revoked. An earlier date, on which one of the grounds for revocation occurred, may be fixed in the decision at the request of one of the parties. 2. The EU trade mark shall be deemed not to have had, as from the outset, the effects specified in this Regulation, to the extent that the trade mark has been declared invalid. 3. Subject to the national provisions relating either to claims for compensation for damage caused by negligence or lack of good faith on the part of the proprietor of the trade mark, or to unjust enrichment, the retroactive effect of revocation or invalidity of the trade mark shall not affect: (a) any decision on infringement which has acquired the authority of a final decision and been enforced prior to the revocation or invalidity decision; (b) any contract concluded prior to the revocation or invalidity decision, in so far as it has been performed before that decision; however, repayment, to an extent justified by the circumstances, of sums paid under the relevant contract may be claimed on grounds of equity. SECTION 5 Proceedings in the office in relation to revocation or invalidity Article 63 Application for revocation or for a declaration of invalidity 1. An application for revocation of the rights of the proprietor of an EU trade mark or for a declaration that the trade mark is invalid may be submitted to the Office: (a) where Articles 58 and 59 apply, by any natural or legal person and any group or body set up for the purpose of representing the interests of manufacturers, producers, suppliers of services, traders or consumers, which, under the terms of the law governing it, has the capacity in its own name to sue and be sued; (b) where Article 60(1) applies, by the persons referred to in Article 46(1); (c) where Article 60(2) applies, by the owners of the earlier rights referred to in that provision or by the persons who are entitled under Union legislation or the law of the Member State concerned to exercise the rights in question. 2. The application shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the fee has been paid. 3. An application for revocation or for a declaration of invalidity shall be inadmissible where an application relating to the same subject matter and cause of action, and involving the same parties, has been adjudicated on its merits, either by the Office or by an EU trade mark court as referred to in Article 123, and the decision of the Office or that court on that application has acquired the authority of a final decision. Article 64 Examination of the application 1. On the examination of the application for revocation of rights or for a declaration of invalidity, the Office shall invite the parties, as often as necessary, to file observations, within a period to be fixed by the Office, on communications from the other parties or issued by itself. 2. If the proprietor of the EU trade mark so requests, the proprietor of an earlier EU trade mark, being a party to the invalidity proceedings, shall furnish proof that, during the period of five years preceding the date of the application for a declaration of invalidity, the earlier EU trade mark has been put to genuine use in the Union in connection with the goods or services in respect of which it is registered and which the proprietor of that earlier trade mark cites as justification for his application, or that there are proper reasons for non-use, provided that the earlier EU trade mark has at that date been registered for not less than five years. If, at the date on which the EU trade mark application was filed or at the priority date of the EU trade mark application, the earlier EU trade mark had been registered for not less than five years, the proprietor of the earlier EU trade mark shall furnish proof that, in addition, the conditions set out in Article 47(2) were satisfied at that date. In the absence of proof to this effect, the application for a declaration of invalidity shall be rejected. If the earlier EU trade mark has been used only in relation to part of the goods or services for which it is registered, it shall, for the purpose of the examination of the application for a declaration of invalidity, be deemed to be registered in respect of that part of the goods or services only. 3. Paragraph 2 shall apply to earlier national trade marks referred to in Article 8(2)(a), by substituting use in the Member State in which the earlier national trade mark is protected for use in the Union. 4. The Office may, if it thinks fit, invite the parties to make a friendly settlement. 5. If the examination of the application for revocation of rights or for a declaration of invalidity reveals that the trade mark should not have been registered in respect of some or all of the goods or services for which it is registered, the rights of the proprietor of the EU trade mark shall be revoked or it shall be declared invalid in respect of those goods or services. Otherwise the application for revocation of rights or for a declaration of invalidity shall be rejected. 6. A record of the Office's decision on the application for revocation of rights or for a declaration of invalidity shall be entered in the Register once it has become final. Article 65 Delegation of powers The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the details of the procedures governing the revocation and declaration of invalidity of an EU trade mark as referred to in Articles 63 and 64, as well as the transfer of an EU trade mark registered in the name of an agent as referred to in Article 21. CHAPTER VII APPEALS Article 66 Decisions subject to appeal 1. An appeal shall lie from decisions of any of the decision-making instances of the Office listed in points (a) to (d) of Article 159, and, where appropriate, point (f) of that Article. Those decisions shall take effect only as from the date of expiration of the appeal period referred to in Article 68. The filing of the appeal shall have suspensive effect. 2. A decision which does not terminate proceedings as regards one of the parties can only be appealed together with the final decision, unless the decision allows separate appeal. Article 67 Persons entitled to appeal and to be parties to appeal proceedings Any party to proceedings adversely affected by a decision may appeal. Any other parties to the proceedings shall be parties to the appeal proceedings as of right. Article 68 Time limit and form of appeal 1. Notice of appeal shall be filed in writing at the Office within two months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. It shall be filed in the language of the proceedings in which the decision subject to appeal was taken. Within four months of the date of notification of the decision, a written statement setting out the grounds of appeal shall be filed. 2. In inter partes proceedings, the defendant may, in his response, seek a decision annulling or altering the contested decision on a point not raised in the appeal. Such submissions shall cease to have effect should the appellant discontinue the proceedings. Article 69 Revision of decisions in ex parte cases 1. If the party which has lodged the appeal is the sole party to the procedure, and if the department whose decision is contested considers the appeal to be admissible and well founded, the department shall rectify its decision. 2. If the decision is not rectified within one month of receipt of the statement of grounds, the appeal shall be remitted to the Board of Appeal without delay, and without comment as to its merit. Article 70 Examination of appeals 1. If the appeal is admissible, the Board of Appeal shall examine whether the appeal is allowable. 2. In the examination of the appeal, the Board of Appeal shall invite the parties, as often as necessary, to file observations, within a period to be fixed by the Board of Appeal, on communications from the other parties or issued by itself. Article 71 Decisions in respect of appeals 1. Following the examination as to the allowability of the appeal, the Board of Appeal shall decide on the appeal. The Board of Appeal may either exercise any power within the competence of the department which was responsible for the decision appealed or remit the case to that department for further prosecution. 2. If the Board of Appeal remits the case for further prosecution to the department whose decision was appealed, that department shall be bound by the ratio decidendi of the Board of Appeal, in so far as the facts are the same. 3. The decisions of the Board of Appeal shall take effect only as from the date of expiry of the period referred to in Article 72(5) or, if an action has been brought before the General Court within that period, as from the date of dismissal of such action or of any appeal filed with the Court of Justice against the decision of the General Court. Article 72 Actions before the Court of Justice 1. Actions may be brought before the General Court against decisions of the Boards of Appeal in relation to appeals. 2. The action may be brought on grounds of lack of competence, infringement of an essential procedural requirement, infringement of the TFEU, infringement of this Regulation or of any rule of law relating to their application or misuse of power. 3. The General Court shall have jurisdiction to annul or to alter the contested decision. 4. The action shall be open to any party to proceedings before the Board of Appeal adversely affected by its decision. 5. The action shall be brought before the General Court within two months of the date of notification of the decision of the Board of Appeal. 6. The Office shall take the necessary measures to comply with the judgment of the General Court or, in the event of an appeal against that judgment, the Court of Justice. Article 73 Delegation of powers The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying: (a) the formal content of the notice of appeal referred to in Article 68 and the procedure for the filing and the examination of an appeal; (b) the formal content and form of the Board of Appeal's decisions as referred to in Article 71; (c) the reimbursement of the appeal fee referred to in Article 68. CHAPTER VIII SPECIFIC PROVISIONS ON EUROPEAN UNION COLLECTIVE MARKS AND CERTIFICATION MARKS SECTION 1 EU collective marks Article 74 EU collective marks 1. A European Union collective mark (‘EU collective mark’) shall be an EU trade mark which is described as such when the mark is applied for and is capable of distinguishing the goods or services of the members of the association which is the proprietor of the mark from those of other undertakings. Associations of manufacturers, producers, suppliers of services, or traders which, under the terms of the law governing them, have the capacity in their own name to have rights and obligations of all kinds, to make contracts or accomplish other legal acts, and to sue and be sued, as well as legal persons governed by public law, may apply for EU collective marks. 2. By way of derogation from Article 7(1)(c), signs or indications which may serve, in trade, to designate the geographical origin of the goods or services may constitute EU collective marks within the meaning of paragraph 1. An EU collective mark shall not entitle the proprietor to prohibit a third party from using in the course of trade such signs or indications, provided that he uses them in accordance with honest practices in industrial or commercial matters; in particular, such a mark shall not be invoked against a third party who is entitled to use a geographical name. 3. Chapters I to VII and IX to XIV shall apply to EU collective marks to the extent that this section does not provide otherwise. Article 75 Regulations governing use of an EU collective mark 1. An applicant for an EU collective mark shall submit regulations governing use within two months of the date of filing. 2. The regulations governing use shall specify the persons authorised to use the mark, the conditions of membership of the association and, where they exist, the conditions of use of the mark, including sanctions. The regulations governing use of a mark referred to in Article 74(2) shall authorise any person whose goods or services originate in the geographical area concerned to become a member of the association which is the proprietor of the mark. 3. The Commission shall adopt implementing acts specifying the details to be contained in the regulations referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 76 Refusal of the application 1. In addition to the grounds for refusal of an EU trade mark application provided for in Articles 41 and 42, an application for an EU collective mark shall be refused where the provisions of Articles 74 or 75 are not satisfied, or where the regulations governing use are contrary to public policy or to accepted principles of morality. 2. An application for an EU collective mark shall also be refused if the public is liable to be misled as regards the character or the significance of the mark, in particular if it is likely to be taken to be something other than a collective mark. 3. An application shall not be refused if the applicant, as a result of amendment of the regulations governing use, meets the requirements of paragraphs 1 and 2. Article 77 Observations by third parties Where written observations on an EU collective mark are submitted to the Office pursuant to Article 45, those observations may also be based on the particular grounds on which the application for an EU collective mark should be refused pursuant to Article 76. Article 78 Use of marks Use of an EU collective mark by any person who has authority to use it shall satisfy the requirements of this Regulation, provided that the other conditions which this Regulation imposes with regard to the use of EU trade marks are fulfilled. Article 79 Amendment of the regulations governing use of the EU collective mark 1. The proprietor of an EU collective mark shall submit to the Office any amended regulations governing use. 2. The amendment shall not be mentioned in the Register if the amended regulations do not satisfy the requirements of Article 75 or involve one of the grounds for refusal referred to in Article 76. 3. Written observations made in accordance with Article 77 may also be submitted with regard to amended regulations governing use. 4. For the purposes of applying this Regulation, amendments to the regulations governing use shall take effect only from the date of entry of the mention of the amendment in the Register. Article 80 Persons who are entitled to bring an action for infringement 1. The provisions of Article 25(3) and (4) concerning the rights of licensees shall apply to every person who has authority to use an EU collective mark. 2. The proprietor of an EU collective mark shall be entitled to claim compensation on behalf of persons who have authority to use the mark where they have sustained damage in consequence of unauthorised use of the mark. Article 81 Grounds for revocation Apart from the grounds for revocation provided for in Article 58, the rights of the proprietor of an EU collective mark shall be revoked on application to the Office or on the basis of a counterclaim in infringement proceedings, if: (a) the proprietor does not take reasonable steps to prevent the mark being used in a manner incompatible with the conditions of use, where these exist, laid down in the regulations governing use, amendments to which have, where appropriate, been mentioned in the Register; (b) the manner in which the mark has been used by the proprietor has caused it to become liable to mislead the public in the manner referred to in Article 76(2); (c) an amendment to the regulations governing use of the mark has been mentioned in the Register in breach of the provisions of Article 79(2), unless the proprietor of the mark, by further amending the regulations governing use, complies with the requirements of those provisions. Article 82 Grounds for invalidity Apart from the grounds for invalidity provided for in Articles 59 and 60, an EU collective mark which is registered in breach of the provisions of Article 76 shall be declared invalid on application to the Office or on the basis of a counterclaim in infringement proceedings, unless the proprietor of the mark, by amending the regulations governing use, complies with the requirements of those provisions. SECTION 2 EU certification marks Article 83 EU certification marks 1. An EU certification mark shall be an EU trade mark which is described as such when the mark is applied for and is capable of distinguishing goods or services which are certified by the proprietor of the mark in respect of material, mode of manufacture of goods or performance of services, quality, accuracy or other characteristics, with the exception of geographical origin, from goods and services which are not so certified. 2. Any natural or legal person, including institutions, authorities and bodies governed by public law, may apply for EU certification marks provided that such person does not carry on a business involving the supply of goods or services of the kind certified. 3. Chapters I to VII and IX to XIV shall apply to EU certification marks to the extent that this Section does not provide otherwise. Article 84 Regulations governing use of an EU certification mark 1. An applicant for an EU certification mark shall submit regulations governing the use of the EU certification mark within two months of the date of filing. 2. The regulations governing use shall specify the persons authorised to use the mark, the characteristics to be certified by the mark, how the certifying body is to test those characteristics and to supervise the use of the mark. Those regulations shall also specify the conditions of use of the mark, including sanctions. 3. The Commission shall adopt implementing acts specifying the details to be contained in the regulations referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 85 Refusal of the application 1. In addition to the grounds for refusal of an EU trade mark application provided for in Articles 41 and 42, an application for an EU certification mark shall be refused where the conditions set out in Articles 83 and 84 are not satisfied, or where the regulations governing use are contrary to public policy or to accepted principles of morality. 2. An application for an EU certification mark shall also be refused if the public is liable to be misled as regards the character or the significance of the mark, in particular if it is likely to be taken to be something other than a certification mark. 3. An application shall not be refused if the applicant, as a result of an amendment of the regulations governing use, meets the requirements of paragraphs 1 and 2. Article 86 Observations by third parties Where written observations on an EU certification mark are submitted to the Office pursuant to Article 45, those observations may also be based on the particular grounds on which the application for an EU certification mark should be refused pursuant to Article 85. Article 87 Use of the EU certification mark Use of an EU certification mark by any person who has authority to use it pursuant to the regulations governing use referred to in Article 84 shall satisfy the requirements of this Regulation, provided that the other conditions laid down in this Regulation with regard to the use of EU trade marks are fulfilled. Article 88 Amendment of the regulations governing use of the EU certification mark 1. The proprietor of an EU certification mark shall submit to the Office any amended regulations governing use. 2. Amendments shall not be mentioned in the Register where the regulations as amended do not satisfy the requirements of Article 84 or involve one of the grounds for refusal referred to in Article 85. 3. Written observations in accordance with Article 86 may also be submitted with regard to amended regulations governing use. 4. For the purposes of this Regulation, amendments to the regulations governing use shall take effect only as from the date of entry of the mention of the amendment in the Register. Article 89 Transfer By way of derogation from Article 20(1), an EU certification mark may only be transferred to a person who meets the requirements of Article 83(2). Article 90 Persons who are entitled to bring an action for infringement 1. Only the proprietor of an EU certification mark, or any person specifically authorised by him to that effect, shall be entitled to bring an action for infringement. 2. The proprietor of an EU certification mark shall be entitled to claim compensation on behalf of persons who have authority to use the mark where they have sustained damage as a consequence of unauthorised use of the mark. Article 91 Grounds for revocation In addition to the grounds for revocation provided for in Article 58, the rights of the proprietor of an EU certification mark shall be revoked on application to the Office or on the basis of a counterclaim in infringement proceedings, where any of the following conditions is fulfilled: (a) the proprietor no longer complies with the requirements set out in Article 83(2); (b) the proprietor does not take reasonable steps to prevent the EU certification mark being used in a manner that is incompatible with the conditions of use laid down in the regulations governing use, amendments to which have, where appropriate, been mentioned in the Register; (c) the manner in which the EU certification mark has been used by the proprietor has caused it to become liable to mislead the public in the manner referred to in Article 85(2); (d) an amendment to the regulations governing use of the EU certification mark has been mentioned in the Register in breach of Article 88(2), unless the proprietor of the mark, by further amending the regulations governing use, complies with the requirements of that Article. Article 92 Grounds for invalidity In addition to the grounds for invalidity provided for in Articles 59 and 60, an EU certification mark which is registered in breach of Article 85 shall be declared invalid on application to the Office or on the basis of a counterclaim in infringement proceedings, unless the proprietor of the EU certification mark, by amending the regulations governing use, complies with the requirements of Article 85. Article 93 Conversion Without prejudice to Article 139(2), conversion of an application for an EU certification mark or of a registered EU certification mark shall not take place where the national law of the Member State concerned does not provide for the registration of guarantee or certification marks pursuant to Article 28 of Directive (EU) 2015/2436. CHAPTER IX PROCEDURE SECTION 1 General provisions Article 94 Decisions and communications of the Office 1. Decisions of the Office shall state the reasons on which they are based. They shall be based only on reasons or evidence on which the parties concerned have had an opportunity to present their comments. Where oral proceedings are held before the Office, the decision may be given orally. Subsequently, the decision shall be notified in writing to the parties. 2. Any decision, communication or notice from the Office shall indicate the department or division of the Office as well as the name or the names of the official or officials responsible. They shall be signed by that official or those officials, or, instead of a signature, carry a printed or stamped seal of the Office. The Executive Director may determine that other means of identifying the department or division of the Office and the name of the official or officials responsible, or an identification other than a seal, may be used where decisions, communications or notices from the Office are transmitted by telecopier or any other technical means of communication. 3. Decisions of the Office which are open to appeal shall be accompanied by a written communication indicating that any notice of appeal is to be filed in writing at the Office within two months of the date of notification of the decision in question. The communications shall also draw the attention of the parties to the provisions laid down in Articles 66, 67 and 68. The parties may not plead any failure on the part of the Office to communicate the availability of appeal proceedings. Article 95 Examination of the facts by the Office of its own motion 1. In proceedings before it the Office shall examine the facts of its own motion; however, in proceedings relating to relative grounds for refusal of registration, the Office shall be restricted in this examination to the facts, evidence and arguments provided by the parties and the relief sought. In invalidity proceedings pursuant to Article 59, the Office shall limit its examination to the grounds and arguments submitted by the parties. 2. The Office may disregard facts or evidence which are not submitted in due time by the parties concerned. Article 96 Oral proceedings 1. If the Office considers that oral proceedings would be expedient they shall be held either at the instance of the Office or at the request of any party to the proceedings. 2. Oral proceedings before the examiners, the Opposition Division and the Department in charge of the Register shall not be public. 3. Oral proceedings, including delivery of the decision, shall be public before the Cancellation Division and the Boards of Appeal, in so far as the department before which the proceedings are taking place does not decide otherwise in cases where admission of the public could have serious and unjustified disadvantages, in particular for a party to the proceedings. 4. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the detailed arrangements for oral proceedings, including the detailed arrangements for the use of languages in accordance with Article 146. Article 97 Taking of evidence 1. In any proceedings before the Office, the means of giving or obtaining evidence shall include the following: (a) hearing the parties; (b) requests for information; (c) the production of documents and items of evidence; (d) hearing witnesses; (e) opinions by experts; (f) statements in writing sworn or affirmed or having a similar effect under the law of the State in which the statement is drawn up. 2. The relevant department may commission one of its members to examine the evidence adduced. 3. If the Office considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. The period of notice provided in such summons shall be at least one month, unless they agree to a shorter period. 4. The parties shall be informed of the hearing of a witness or expert before the Office. They shall have the right to be present and to put questions to the witness or expert. 5. The Executive Director shall determine the amounts of expenses to be paid, including advances, as regards the costs of taking of evidence as referred to in this Article. 6. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the detailed arrangements for the taking of evidence. Article 98 Notification 1. The Office shall, as a matter of course, notify those concerned of decisions and summonses and of any notice or other communication from which a time limit is reckoned, or of which those concerned are to be notified under other provisions of this Regulation or of acts adopted pursuant to this Regulation, or of which notification has been ordered by the Executive Director. 2. The Executive Director may determine which documents other than decisions subject to a time limit for appeal and summonses shall be notified by registered letter with proof of delivery. 3. Notification may be effected by different means, including by electronic means. The details regarding electronic means shall be determined by the Executive Director. 4. Where notification is to be effected by public notice, the Executive Director shall determine how the public notice is to be given and shall fix the beginning of the one-month period on the expiry of which the document shall be deemed to have been notified. 5. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the detailed arrangements for notification. Article 99 Notification of loss of rights Where the Office finds that the loss of any rights results from this Regulation or acts adopted pursuant to this Regulation, without any decision having been taken, it shall communicate this to the person concerned in accordance with Article 98. The latter may apply for a decision on the matter within two months of notification of the communication, if he considers that the finding of the Office is incorrect. The Office shall adopt such a decision only where it disagrees with the person requesting it; otherwise the Office shall amend its finding and inform the person requesting the decision. Article 100 Communications to the Office 1. Communications addressed to the Office may be effected by electronic means. The Executive Director shall determine to what extent and under which technical conditions those communications may be submitted electronically. 2. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the rules on the means of communication, including the electronic means of communication, to be used by the parties to proceedings before the Office and the forms to be made available by the Office. Article 101 Time limits 1. Time limits shall be laid down in terms of full years, months, weeks or days. Calculation shall start on the day following the day on which the relevant event occurred. The duration of time limits shall be no less than one month and no more than six months. 2. The Executive Director shall determine, before the commencement of each calendar year, the days on which the Office is not open for receipt of documents or on which ordinary post is not delivered in the locality in which the Office is located. 3. The Executive Director shall determine the duration of the period of interruption in the case of a general interruption in the delivery of post in the Member State where the Office is located or, in the case of an actual interruption of the Office's connection to admitted electronic means of communication. 4. If an exceptional occurrence, such as a natural disaster or strike, interrupts or interferes with proper communication from the parties to the proceedings to the Office or vice-versa, the Executive Director may determine that for parties to the proceedings having their residence or registered office in the Member State concerned or who have appointed a representative with a place of business in the Member State concerned all time limits that otherwise would expire on or after the date of commencement of such occurrence, as determined by him, shall extend until a date to be determined by him. When determining that date, he shall assess when the exceptional occurrence comes to an end. If the occurrence affects the seat of the Office, such determination of the Executive Director shall specify that it applies in respect of all parties to the proceedings. 5. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the details regarding the calculation and duration of time limits. Article 102 Correction of errors and manifest oversights 1. The Office shall correct any linguistic errors or errors of transcription and manifest oversights in its decisions, or technical errors attributable to it in registering an EU trade mark or in publishing the registration of its own motion or at the request of a party. 2. Where the correction of errors in the registration of an EU trade mark or the publication of the registration is requested by the proprietor, Article 55 shall apply mutatis mutandis. 3. Corrections of errors in the registration of an EU trade mark and in the publication of the registration shall be published by the Office. Article 103 Revocation of decisions 1. Where the Office has made an entry in the Register or taken a decision which contains an obvious error attributable to the Office, it shall ensure that the entry is cancelled or the decision is revoked. Where there is only one party to the proceedings and the entry or the act affects its rights, cancellation or revocation shall be determined even if the error was not evident to the party. 2. Cancellation or revocation as referred to in paragraph 1 shall be determined, ex officio or at the request of one of the parties to the proceedings, by the department which made the entry or took the decision. The cancellation of the entry in the Register or the revocation of the decision shall be effected within one year of the date on which the entry was made in the Register or that decision was taken, after consultation with the parties to the proceedings and any proprietor of rights to the EU trade mark in question that are entered in the Register. The Office shall keep records of any such cancellation or revocation. 3. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the procedure for the revocation of a decision or for the cancellation of an entry in the Register. 4. This Article shall be without prejudice to the right of the parties to submit an appeal under Articles 66 and 72, or to the possibility of correcting errors and manifest oversights under Article 102. Where an appeal has been filed against a decision of the Office containing an error, the appeal proceedings shall become devoid of purpose upon revocation by the Office of its decision pursuant to paragraph 1 of this Article. In the latter case, the appeal fee shall be reimbursed to the appellant. Article 104 Restitutio in integrum 1. The applicant for or proprietor of an EU trade mark or any other party to proceedings before the Office who, in spite of all due care required by the circumstances having been taken, was unable to comply with a time limit vis-à-vis the Office shall, upon application, have his rights re-established if the obstacle to compliance has the direct consequence, by virtue of the provisions of this Regulation, of causing the loss of any right or means of redress. 2. The application shall be filed in writing within two months of the removal of the obstacle to compliance with the time limit. The omitted act shall be completed within this period. The application shall only be admissible within the year immediately following the expiry of the unobserved time limit. In the case of non-submission of the request for renewal of registration or of non-payment of a renewal fee, the further period of six months provided in the third sentence of Article 53(3) shall be deducted from the period of one year. 3. The application shall state the grounds on which it is based and shall set out the facts on which it relies. It shall not be deemed to be filed until the fee for re-establishment of rights has been paid. 4. The department competent to decide on the omitted act shall decide upon the application. 5. This Article shall not be applicable to the time limits referred to in paragraph 2 of this Article, Article 46(1) and (3) and Article 105. 6. Where the applicant for or proprietor of an EU trade mark has his rights re-established, he may not invoke his rights vis-à-vis a third party who, in good faith, has put goods on the market or supplied services under a sign which is identical with, or similar to, the EU trade mark in the course of the period between the loss of rights in the application or in the EU trade mark and publication of the mention of re-establishment of those rights. 7. A third party who may avail himself of the provisions of paragraph 6 may bring third party proceedings against the decision re-establishing the rights of the applicant for or proprietor of an EU trade mark within a period of two months as from the date of publication of the mention of re-establishment of those rights. 8. Nothing in this Article shall limit the right of a Member State to grant restitutio in integrum in respect of time limits provided for in this Regulation and to be observed vis-à-vis the authorities of such State. Article 105 Continuation of proceedings 1. An applicant for or proprietor of an EU trade mark or any other party to proceedings before the Office who has omitted to observe a time limit vis-à-vis the Office may, upon request, obtain the continuation of proceedings, provided that at the time the request is made the omitted act has been carried out. The request for continuation of proceedings shall be admissible only if it is submitted within two months of the expiry of the unobserved time limit. The request shall not be deemed to have been filed until the fee for continuation of the proceedings has been paid. 2. This Article shall not apply to the time limits laid down in Article 32, Article 34(1), Article 38(1), Article 41(2), Article 46(1) and (3), Article 53(3), Article 68, Article 72(5), Article 104(2) and Article 139, or to the time limits laid down in paragraph 1 of this Article or the time limit for claiming seniority pursuant to Article 39 after the application has been filed. 3. The department competent to decide on the omitted act shall decide upon the application. 4. If the Office accepts the application, the consequences of having failed to observe the time limit shall be deemed not to have occurred. If a decision has been taken between the expiry of that time limit and the request for the continuation of proceedings, the department competent to decide on the omitted act shall review the decision and, where completion of the omitted act itself is sufficient, take a different decision. If, following the review, the Office concludes that the original decision does not require to be altered, it shall confirm that decision in writing. 5. If the Office rejects the application, the fee shall be refunded. Article 106 Interruption of proceedings 1. Proceedings before the Office shall be interrupted: (a) in the event of the death or legal incapacity of the applicant for, or proprietor of, an EU trade mark or of the person authorised by national law to act on his behalf. To the extent that that death or incapacity does not affect the authorisation of a representative appointed under Article 120, proceedings shall be interrupted only on application by such representative; (b) in the event of the applicant for, or proprietor of, an EU trade mark being prevented, for legal reasons resulting from action taken against his property, from continuing the proceedings before the Office; (c) in the event of the death or legal incapacity of the representative of an applicant for, or proprietor of, an EU trade mark, or of that representative being prevented, for legal reasons resulting from action taken against his property, from continuing the proceedings before the Office. 2. Proceedings before the Office shall be resumed as soon as the identity of the person authorised to continue them has been established. 3. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the detailed arrangements for the resumption of proceedings before the Office. Article 107 Reference to general principles In the absence of procedural provisions in this Regulation or in acts adopted pursuant to this Regulation, the Office shall take into account the principles of procedural law generally recognised in the Member States. Article 108 Termination of financial obligations 1. Rights of the Office to the payment of a fee shall be extinguished after four years from the end of the calendar year in which the fee fell due. 2. Rights against the Office for the refunding of fees or sums of money paid in excess of a fee shall be extinguished after four years from the end of the calendar year in which the right arose. 3. The period laid down in paragraphs 1 and 2 shall be interrupted, in the case covered by paragraph 1, by a request for payment of the fee, and in the case covered by paragraph 2, by a reasoned claim in writing. On interruption it shall begin again immediately and shall end at the latest six years after the end of the year in which it originally began, unless, in the meantime, judicial proceedings to enforce the right have begun; in this case the period shall end at the earliest one year after the judgment has acquired the authority of a final decision. SECTION 2 Costs Article 109 Costs 1. The losing party in opposition proceedings, proceedings for revocation, proceedings for a declaration of invalidity or appeal proceedings shall bear the fees paid by the other party. Without prejudice to Article 146(7), the losing party shall also bear all costs incurred by the other party that are essential to the proceedings, including travel and subsistence and the remuneration of a representative within the meaning of Article 120(1), within the limits of the scales set for each category of costs in the implementing act to be adopted in accordance with paragraph 2 of this Article. The fees to be borne by the losing party shall be limited to the fees paid by the other party for opposition, for an application for revocation or for a declaration of invalidity of the EU trade mark and for appeal. 2. The Commission shall adopt implementing acts specifying the maximum rates for costs essential to the proceedings and actually incurred by the successful party. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). When specifying such amounts with respect to travel and subsistence costs, the Commission shall take into account the distance between the place of residence or business of the party, representative or witness or expert and the place where the oral proceedings are held, the procedural stage at which the costs have been incurred, and, as far as costs of representation within the meaning of Article 120(1) are concerned, the need to ensure that the obligation to bear the costs may not be misused for tactical reasons by the other party. Subsistence expenses shall be calculated in accordance with the Staff Regulations of Officials of the Union and the Conditions of Employment of Other Servants of the Union, laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (15) (‘the Staff Regulations’ and ‘Conditions of Employment’ respectively). The losing party shall bear the costs for one opposing party only and, where applicable, one representative only. 3. However, where each party succeeds on some and fails on other heads, or if reasons of equity so dictate, the Opposition Division, Cancellation Division or Board of Appeal shall decide a different apportionment of costs. 4. The party who terminates the proceedings by withdrawing the EU trade mark application, the opposition, the application for revocation of rights, the application for a declaration of invalidity or the appeal, or by not renewing registration of the EU trade mark or by surrendering the EU trade mark, shall bear the fees and the costs incurred by the other party as stipulated in paragraphs 1 and 3. 5. Where a case does not proceed to judgment the costs shall be at the discretion of the Opposition Division, Cancellation Division or Board of Appeal. 6. Where the parties conclude before the Opposition Division, Cancellation Division or Board of Appeal a settlement of costs differing from that provided for in paragraphs 1 to 5, the department concerned shall take note of that agreement. 7. The Opposition Division or Cancellation Division or Board of Appeal shall fix the amount of the costs to be paid pursuant to paragraphs 1 to 6 of this Article when the costs to be paid are limited to the fees paid to the Office and the representation costs. In all other cases, the registry of the Board of Appeal or a member of the staff of the Opposition Division or Cancellation Division shall fix, on request, the amount of the costs to be reimbursed. The request shall be admissible only for the period of two months following the date on which the decision for which an application was made for the costs to be fixed becomes final and shall be accompanied by a bill and supporting evidence. For the costs of representation pursuant to Article 120(1), an assurance by the representative that the costs have been incurred shall be sufficient. For other costs, it shall be sufficient if their plausibility is established. Where the amount of the costs is fixed pursuant to the first sentence of this paragraph, representation costs shall be awarded at the level laid down in the implementing act adopted pursuant to paragraph 2 of this Article and irrespective of whether they have been actually incurred. 8. The decision on the fixing of costs, stating the reasons on which it is based, may be reviewed by a decision of the Opposition Division or Cancellation Division or Board of Appeal on a request filed within one month of the date of notification of the awarding of costs. It shall not be deemed to be filed until the fee for reviewing the amount of the costs has been paid. The Opposition Division, the Cancellation Division or the Board of Appeal, as the case may be, shall take a decision on the request for a review of the decision on the fixing of costs without oral proceedings. Article 110 Enforcement of decisions fixing the amount of costs 1. Any final decision of the Office fixing the amount of costs shall be enforceable. 2. Enforcement shall be governed by the rules of civil procedure in force in the State in the territory of which it is carried out. Each Member State shall designate a single authority responsible for verifying the authenticity of the decision referred to in paragraph 1 and shall communicate its contact details to the Office, the Court of Justice and the Commission. The order for the enforcement of the decision shall be appended to the decision by that authority, with the verification of the authenticity of the decision as the sole formality. 3. When these formalities have been completed on application by the party concerned, the latter may proceed to enforcement in accordance with the national law, by bringing the matter directly before the competent authority. 4. Enforcement may be suspended only by a decision of the Court of Justice. However, the courts of the country concerned shall have jurisdiction over complaints that enforcement is being carried out in an irregular manner. SECTION 3 Information which may be made available to the public and to the authorities of the Member States Article 111 Register of EU trade marks 1. The Office shall keep a Register of EU trade marks which it shall keep up to date. 2. The Register shall contain the following entries relating to EU trade mark applications and registrations: (a) the date of filing the application; (b) the file number of the application; (c) the date of the publication of the application; (d) the name and address of the applicant; (e) the name and business address of the representative, other than a representative as referred to in the first sentence of Article 119(3); (f) the representation of the mark, with indications as to its nature; and, where applicable, a description of the mark; (g) an indication of the goods and services by their names; (h) particulars of claims of priority pursuant to Article 35; (i) particulars of claims of exhibition priority pursuant to Article 38; (j) particulars of claims of seniority of a registered earlier trade mark as referred to in Article 39; (k) a statement that the mark has become distinctive in consequence of the use which has been made of it, pursuant to Article 7(3); (l) an indication that the mark is a collective mark; (m) an indication that the mark is a certification mark; (n) the language in which the application was filed and the second language which the applicant has indicated in his application, pursuant to Article 146(3); (o) the date of registration of the mark in the Register and the registration number; (p) a statement that the application is the result of a transformation of an international registration designating the Union, pursuant to Article 204 of this Regulation, together with the date of the international registration pursuant to Article 3(4) of the Madrid Protocol or the date on which the territorial extension to the Union made subsequent to the international registration pursuant to Article 3ter(2) of the Madrid Protocol was recorded and, where applicable, the date of priority of the international registration. 3. The Register shall also contain the following entries, each accompanied by the date of recording of such entry: (a) changes in the name, address or nationality of the proprietor of an EU trade mark or a change in the State in which he is domiciled or has his seat or establishment; (b) changes in the name or business address of the representative, other than a representative as referred to in the first sentence of Article 119(3); (c) where a new representative is appointed, the name and business address of that representative; (d) amendments and alterations of the mark, pursuant to Articles 49 and 54, and corrections of errors; (e) notice of amendments to the regulations governing the use of the collective mark pursuant to Article 79; (f) particulars of claims of seniority of a registered earlier trade mark as referred to in Article 39, pursuant to Article 40; (g) total or partial transfers pursuant to Article 20; (h) creation or transfer of a right in rem pursuant to Article 22, and the nature of the right in rem; (i) levy of execution pursuant to Article 23 and insolvency proceedings pursuant to Article 24; (j) the grant or transfer of a licence pursuant to Article 25 and, where applicable, the type of licence; (k) renewal of a registration pursuant to Article 53, the date from which it takes effect and any restrictions pursuant to Article 53(4); (l) a record of a determination of the expiry of a registration pursuant to Article 53; (m) declarations of withdrawal or surrender by the proprietor of the mark pursuant to Articles 49 and 57 respectively; (n) the date of submission and the particulars of an opposition pursuant to Article 46, of an application pursuant to Article 63, or a counterclaim pursuant to Article 128(4) for revocation or for a declaration of invalidity, or of an appeal pursuant to Article 68; (o) the date and content of a decision on an opposition, on an application or counterclaim pursuant to Article 64(6) or the third sentence of Article 128(6), or on an appeal pursuant to Article 71; (p) a record of the receipt of a request for conversion pursuant to Article 140(2); (q) the cancellation of the representative recorded pursuant to point (e) of paragraph 2 of this Article; (r) the cancellation of the seniority of a national mark; (s) the modification to or cancellation from the Register of the items referred to in points (h), (i) and (j) of this paragraph; (t) the replacement of the EU trade mark by an international registration pursuant to Article 197; (u) the date and number of international registrations based on the EU trade mark application which has been registered as an EU trade mark pursuant to Article 185(1); (v) the date and number of international registrations based on the EU trade mark pursuant to Article 185(2); (w) the division of an application pursuant to Article 50 and the division of a registration pursuant to Article 56, together with the items referred to in paragraph 2 of this Article in respect of the divisional registration, as well as the list of goods and services of the original registration as amended; (x) the revocation of a decision or an entry in the Register pursuant to Article 103, where the revocation concerns a decision or entry which has been published; (y) notice of amendments to the regulations governing the use of the EU certification mark pursuant to Article 88. 4. The Executive Director may determine that items other than those referred to in paragraphs 2 and 3 of this Article are to be entered in the Register, subject to Article 149(4). 5. The Register may be maintained in electronic form. The Office shall collect, organise, make public and store the items referred to in paragraphs 2 and 3, including any personal data, for the purposes laid down in paragraph 8. The Office shall keep the register easily accessible for public inspection. 6. The proprietor of an EU trade mark shall be notified of any change in the Register. 7. The Office shall provide certified or uncertified extracts from the Register on request and on payment of a fee. 8. The processing of the data concerning the entries set out in paragraphs 2 and 3, including any personal data, shall take place for the purposes of: (a) administering the applications and/or registrations as described in this Regulation and acts adopted pursuant to it; (b) maintaining a public register for inspection by, and the information of, public authorities and economic operators, in order to enable them to exercise the rights conferred on them by this Regulation and be informed about the existence of prior rights belonging to third parties; and (c) producing reports and statistics enabling the Office to optimise its operations and improve the functioning of the system. 9. All the data, including personal data, concerning the entries in paragraphs 2 and 3 shall be considered to be of public interest and may be accessed by any third party. For reasons of legal certainty, the entries in the Register shall be kept for an indefinite period of time. Article 112 Database 1. In addition to the obligation to keep a Register within the meaning of Article 111, the Office shall collect and store in an electronic database all the particulars provided by applicants or any other party to the proceedings pursuant to this Regulation or acts adopted pursuant to it. 2. The electronic database may include personal data, beyond those included in the Register pursuant to Article 111, to the extent that such particulars are required by this Regulation or by acts adopted pursuant to it. The collection, storage and processing of such data shall serve the purposes of: (a) administering the applications and/or registrations as described in this Regulation and in acts adopted pursuant to it; (b) accessing the information necessary for conducting the relevant proceedings more easily and efficiently; (c) communicating with the applicants and other parties to the proceedings; (d) producing reports and statistics enabling the Office to optimise its operations and improve the functioning of the system. 3. The Executive Director shall determine the conditions of access to the electronic database and the manner in which its contents, other than the personal data referred to in paragraph 2 of this Article but including those listed in Article 111, may be made available in machine-readable form, including the charge for such access. 4. Access to the personal data referred to in paragraph 2 shall be restricted and such data shall not be made publicly available unless the party concerned has given his express consent. 5. All data shall be kept indefinitely. However, the party concerned may request the removal of any personal data from the database after 18 months from the expiry of the EU trade mark or the closure of the relevant inter partes procedure. The party concerned shall have the right to obtain the correction of inaccurate or erroneous data at any time. Article 113 Online access to decisions 1. The decisions of the Office shall be made available online for the information and consultation of the general public in the interest of transparency and predictability. Any party to the proceedings that led to the adoption of the decision may request the removal of any personal data included in the decision. 2. The Office may provide online access to judgments of national and Union courts related to its tasks in order to raise public awareness of intellectual property matters and promote convergence of practices. The Office shall respect the conditions of the initial publication with regard to personal data. Article 114 Inspection of files 1. The files relating to EU trade mark applications which have not yet been published shall not be made available for inspection without the consent of the applicant. 2. Any person who can prove that the applicant for an EU trade mark has stated that after the trade mark has been registered he will invoke the rights under it against him may obtain inspection of the files prior to the publication of that application and without the consent of the applicant. 3. Subsequent to the publication of the EU trade mark application, the files relating to such application and the resulting trade mark may be inspected on request. 4. Where the files are inspected pursuant to paragraph 2 or 3 of this Article, documents relating to exclusion or objection pursuant to Article 169, draft decisions and opinions, and all other internal documents used for the preparation of decisions and opinions, as well as parts of the file which the party concerned showed a special interest in keeping confidential before the request for inspection of the files was made, unless inspection of such parts of the file is justified by overriding, legitimate interests of the party seeking inspection, may be withheld from inspection. 5. Inspection of the files of EU trade mark applications and of registered EU trade marks shall be of the original document, or of copies thereof, or of technical means of storage if the files are stored in this way. The Executive Director shall determine the means of inspection. 6. Where inspection of files takes place as provided for in paragraph 7, the request for inspection of the files shall not be deemed to have been made until the required fee has been paid. No fee shall be payable if inspection of technical means of storage takes place online. 7. Inspection of the files shall take place at the premises of the Office. On request, inspection of the files shall be effected by means of issuing copies of file documents. The issuing of such copies shall be conditional on the payment of a fee. The Office shall also issue on request certified or uncertified copies of the application for an EU trade mark upon payment of a fee. 8. The files kept by the Office relating to international registrations designating the Union may be inspected on request as from the date of publication referred to in Article 190(1), in accordance with the conditions laid down in paragraphs 1, 3 and 4 of this Article. 9. Subject to the restrictions provided for in paragraph 4, the Office may, on request, communicate information from any file of an EU trade mark applied for or of a registered EU trade mark, subject to payment of a fee. However, the Office may require the exercise of the option to obtain inspection of the file itself should it deem this to be appropriate in view of the quantity of information to be supplied. Article 115 Keeping of files 1. The Office shall keep the files of any procedure relating to an EU trade mark application or EU trade mark registration. The Executive Director shall determine the form in which those files shall be kept. 2. Where the files are kept in electronic format, the electronic files, or back-up copies thereof, shall be kept indefinitely. The original documents filed by parties to the proceedings, and forming the basis of such electronic files, shall be disposed of after a period following their reception by the Office, which shall be determined by the Executive Director. 3. Where and to the extent that files or parts of the files are kept in any form other than electronically, documents or items of evidence constituting part of such files shall be kept for at least five years from the end of the year in which the application is rejected or withdrawn or is deemed to be withdrawn, the registration of the EU trade mark expires completely pursuant to Article 53, the complete surrender of the EU trade mark is registered pursuant to Article 57, or the EU trade mark is completely removed from the Register pursuant to Article 64(6) or 128(6). Article 116 Periodical publications 1. The Office shall periodically publish: (a) a European Union Trade Marks Bulletin containing publications of applications and of entries made in the Register as well as other particulars relating to applications or registrations of EU trade marks the publication of which is required under this Regulation or by acts adopted pursuant to it; (b) an Official Journal of the Office containing notices and information of a general character issued by the Executive Director, as well as any other information relevant to this Regulation or its implementation. The publications referred to in points (a) and (b) of the first subparagraph may be effected by electronic means. 2. The European Union Trade Marks Bulletin shall be published in a manner and at a frequency to be determined by the Executive Director. 3. The Official Journal of the Office shall be published in the languages of the Office. However, the Executive Director may determine that certain items shall be published in the Official Journal of the Office in the official languages of the Union. 4. The Commission shall adopt implementing acts specifying: (a) the date to be taken as the date of publication in the European Union Trade Marks Bulletin; (b) the manner of publication of entries regarding the registration of a trade mark which do not contain changes as compared to the publication of the application; (c) the forms in which editions of the Official Journal of the Office may be made available to the public. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 117 Administrative cooperation 1. Unless otherwise provided in this Regulation or in national laws, the Office and the courts or authorities of the Member States shall on request give assistance to each other by communicating information or opening files for inspection. Where the Office lays files open to inspection by courts, Public Prosecutors' Offices or central industrial property offices, the inspection shall not be subject to the restrictions laid down in Article 114. 2. The Office shall not charge fees for the communication of information or the opening of files for inspection. 3. The Commission shall adopt implementing acts specifying the detailed arrangements as to how the Office and the authorities of the Member States are to exchange information between each other and open files for inspection, taking into account the restrictions to which the inspection of files relating to EU trade mark applications or registrations is subject, pursuant to Article 114, when it is opened to third parties. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 118 Exchange of publications 1. The Office and the central industrial property offices of the Member States shall despatch to each other on request and for their own use one or more copies of their respective publications free of charge. 2. The Office may conclude agreements relating to the exchange or supply of publications. SECTION 4 Representation Article 119 General principles of representation 1. Subject to the provisions of paragraph 2, no person shall be compelled to be represented before the Office. 2. Without prejudice to the second sentence of paragraph 3 of this Article, natural or legal persons having neither their domicile nor their principal place of business or a real and effective industrial or commercial establishment in the European Economic Area shall be represented before the Office in accordance with Article 120(1) in all proceedings provided for by this Regulation, other than the filing of an application for an EU trade mark. 3. Natural or legal persons having their domicile or principal place of business or a real and effective industrial or commercial establishment in the European Economic Area may be represented before the Office by an employee. An employee of a legal person to which this paragraph applies may also represent other legal persons which have economic connections with the first legal person, even if those other legal persons have neither their domicile nor their principal place of business nor a real and effective industrial or commercial establishment within the European Economic Area. Employees who represent persons, within the meaning of this paragraph, shall, at the request of the Office or, where appropriate, of the party to the proceedings, file with it a signed authorisation for insertion in the files. 4. Where there is more than one applicant or more than one third party acting in common, a common representative shall be appointed. Article 120 Professional representatives 1. Representation of natural or legal persons before the Office may only be undertaken by: (a) a legal practitioner qualified in one of the Member States of the European Economic Area and having his place of business within the European Economic Area, to the extent that he is entitled, within the said Member State, to act as a representative in trade mark matters; (b) professional representatives whose names appear on the list maintained for this purpose by the Office. Representatives acting before the Office shall, at the request of the Office or, where appropriate, of the other party to the proceedings, file with it a signed authorisation for insertion on the files. 2. Any natural person who fulfils the following conditions may be entered on the list of professional representatives: (a) being a national of one of the Member States of the European Economic Area; (b) having his place of business or employment in the European Economic Area; (c) being entitled to represent natural or legal persons in trade mark matters before the Benelux Office for Intellectual Property or before the central industrial property office of a Member State of the European Economic Area. Where, in the State concerned, the entitlement is not conditional upon the requirement of special professional qualifications, persons applying to be entered on the list who act in trade mark matters before the Benelux Office for Intellectual Property or those central industrial property offices shall have habitually so acted for at least five years. However, persons whose professional qualification to represent natural or legal persons in trade mark matters before the Benelux Office for Intellectual Property or those central industrial property offices is officially recognised in accordance with the regulations laid down by the State concerned shall not be required to have exercised the profession. 3. Entry shall be effected upon request, accompanied by a certificate furnished by the central industrial property office of the Member State concerned, indicating that the conditions laid down in paragraph 2 are fulfilled. 4. The Executive Director may grant an exemption from: (a) the requirement in the second sentence of paragraph 2(c), if the applicant furnishes proof that he has acquired the requisite qualification in another way; (b) the requirement set out in paragraph 2(a) in the case of highly qualified professionals, provided that the requirements set out in paragraph 2(b) and (c) are fulfilled. 5. A person may be removed from the list of professional representatives at his request or when no longer in a capacity to represent. The amendments of the list of professional representatives shall be published in the Official Journal of the Office. Article 121 Delegation of powers The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying: (a) the conditions and the procedure for the appointment of a common representative as referred to in Article 119(4); (b) the conditions under which employees referred to in Article 119(3) and professional representatives referred to in Article 120(1) shall file with the Office a signed authorisation in order to undertake representation, and the content of that authorisation; (c) the circumstances in which a person may be removed from the list of professional representatives referred to in Article 120(5). CHAPTER X JURISDICTION AND PROCEDURE IN LEGAL ACTIONS RELATING TO EU TRADE MARKS SECTION 1 Application of Union rules on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters Article 122 Application of Union rules on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters 1. Unless otherwise specified in this Regulation, the Union rules on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters shall apply to proceedings relating to EU trade marks and applications for EU trade marks, as well as to proceedings relating to simultaneous and successive actions on the basis of EU trade marks and national trade marks. 2. In the case of proceedings in respect of the actions and claims referred to in Article 124: (a) Articles 4 and 6, points 1, 2, 3 and 5 of Article 7 and Article 35 of Regulation (EU) No 1215/2012 shall not apply; (b) Articles 25 and 26 of Regulation (EU) No 1215/2012 shall apply subject to the limitations in Article 125(4) of this Regulation; (c) the provisions of Chapter II of Regulation (EU) No 1215/2012 which are applicable to persons domiciled in a Member State shall also be applicable to persons who do not have a domicile in any Member State but have an establishment therein. 3. References in this Regulation to Regulation (EU) No 1215/2012 shall include, where appropriate, the Agreement between the European Community and the Kingdom of Denmark on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters done on 19 October 2005. SECTION 2 Disputes concerning the infringement and validity of EU trade marks Article 123 EU trade mark courts 1. The Member States shall designate in their territories as limited a number as possible of national courts and tribunals of first and second instance, which shall perform the functions assigned to them by this Regulation. 2. Any change made in the number, names or territorial jurisdiction of the courts included in the list of EU trade mark courts communicated by a Member State to the Commission in accordance with Article 95(2) of Regulation (EC) No 207/2009 shall be notified without delay by the Member State concerned to the Commission. 3. The information referred to in paragraph 2 shall be notified by the Commission to the Member States and published in the Official Journal of the European Union. Article 124 Jurisdiction over infringement and validity The EU trade mark courts shall have exclusive jurisdiction: (a) for all infringement actions and — if they are permitted under national law — actions in respect of threatened infringement relating to EU trade marks; (b) for actions for declaration of non-infringement, if they are permitted under national law; (c) for all actions brought as a result of acts referred to in Article 11(2); (d) for counterclaims for revocation or for a declaration of invalidity of the EU trade mark pursuant to Article 128. Article 125 International jurisdiction 1. Subject to the provisions of this Regulation as well as to any provisions of Regulation (EU) No 1215/2012 applicable by virtue of Article 122, proceedings in respect of the actions and claims referred to in Article 124 shall be brought in the courts of the Member State in which the defendant is domiciled or, if he is not domiciled in any of the Member States, in which he has an establishment. 2. If the defendant is neither domiciled nor has an establishment in any of the Member States, such proceedings shall be brought in the courts of the Member State in which the plaintiff is domiciled or, if he is not domiciled in any of the Member States, in which he has an establishment. 3. If neither the defendant nor the plaintiff is so domiciled or has such an establishment, such proceedings shall be brought in the courts of the Member State where the Office has its seat. 4. Notwithstanding the provisions of paragraphs 1, 2 and 3: (a) Article 25 of Regulation (EU) No 1215/2012 shall apply if the parties agree that a different EU trade mark court shall have jurisdiction; (b) Article 26 of Regulation (EU) No 1215/2012 shall apply if the defendant enters an appearance before a different EU trade mark court. 5. Proceedings in respect of the actions and claims referred to in Article 124, with the exception of actions for a declaration of non-infringement of an EU trade mark, may also be brought in the courts of the Member State in which the act of infringement has been committed or threatened, or in which an act referred to in Article 11(2) has been committed. Article 126 Extent of jurisdiction 1. An EU trade mark court whose jurisdiction is based on Article 125(1) to (4) shall have jurisdiction in respect of: (a) acts of infringement committed or threatened within the territory of any of the Member States; (b) acts referred to in Article 11(2) committed within the territory of any of the Member States. 2. An EU trade mark court whose jurisdiction is based on Article 125(5) shall have jurisdiction only in respect of acts committed or threatened within the territory of the Member State in which that court is situated. Article 127 Presumption of validity — Defence as to the merits 1. The EU trade mark courts shall treat the EU trade mark as valid unless its validity is put in issue by the defendant with a counterclaim for revocation or for a declaration of invalidity. 2. The validity of an EU trade mark may not be put in issue in an action for a declaration of non-infringement. 3. In the actions referred to in points (a) and (c) of Article 124, a plea relating to revocation of the EU trade mark submitted otherwise than by way of a counterclaim shall be admissible where the defendant claims that the EU trade mark could be revoked for lack of genuine use at the time the infringement action was brought. Article 128 Counterclaims 1. A counterclaim for revocation or for a declaration of invalidity may only be based on the grounds for revocation or invalidity mentioned in this Regulation. 2. An EU trade mark court shall reject a counterclaim for revocation or for a declaration of invalidity if a decision taken by the Office relating to the same subject matter and cause of action and involving the same parties has already become final. 3. If the counterclaim is brought in a legal action to which the proprietor of the trade mark is not already a party, he shall be informed thereof and may be joined as a party to the action in accordance with the conditions set out in national law. 4. The EU trade mark court with which a counterclaim for revocation or for a declaration of invalidity of the EU trade mark has been filed shall not proceed with the examination of the counterclaim, until either the interested party or the court has informed the Office of the date on which the counterclaim was filed. The Office shall record that information in the Register. If an application for revocation or for a declaration of invalidity of the EU trade mark had already been filed before the Office before the counterclaim was filed, the court shall be informed thereof by the Office and stay the proceedings in accordance with Article 132(1) until the decision on the application is final or the application is withdrawn. 5. Article 64(2) to (5) shall apply. 6. Where an EU trade mark court has given a judgment which has become final on a counterclaim for revocation or for a declaration of invalidity of an EU trade mark, a copy of the judgment shall be sent to the Office without delay, either by the court or by any of the parties to the national proceedings. The Office or any other interested party may request information about such transmission. The Office shall mention the judgment in the Register and shall take the necessary measures to comply with its operative part. 7. The EU trade mark court hearing a counterclaim for revocation or for a declaration of invalidity may stay the proceedings on application by the proprietor of the EU trade mark and after hearing the other parties and may request the defendant to submit an application for revocation or for a declaration of invalidity to the Office within a time limit which it shall determine. If the application is not made within the time limit, the proceedings shall continue; the counterclaim shall be deemed withdrawn. Article 132(3) shall apply. Article 129 Applicable law 1. The EU trade mark courts shall apply the provisions of this Regulation. 2. On all trade mark matters not covered by this Regulation, the relevant EU trade mark court shall apply the applicable national law. 3. Unless otherwise provided for in this Regulation, an EU trade mark court shall apply the rules of procedure governing the same type of action relating to a national trade mark in the Member State in which the court is located. Article 130 Sanctions 1. Where an EU trade mark court finds that the defendant has infringed or threatened to infringe an EU trade mark, it shall, unless there are special reasons for not doing so, issue an order prohibiting the defendant from proceeding with the acts which infringed or would infringe the EU trade mark. It shall also take such measures in accordance with its national law as are aimed at ensuring that this prohibition is complied with. 2. The EU trade mark court may also apply measures or orders available under the applicable law which it deems appropriate in the circumstances of the case. Article 131 Provisional and protective measures 1. Application may be made to the courts of a Member State, including EU trade mark courts, for such provisional, including protective, measures in respect of an EU trade mark or EU trade mark application as may be available under the law of that State in respect of a national trade mark, even if, under this Regulation, an EU trade mark court of another Member State has jurisdiction as to the substance of the matter. 2. An EU trade mark court whose jurisdiction is based on Article 125(1), (2), (3) or (4) shall have jurisdiction to grant provisional and protective measures which, subject to any necessary procedure for recognition and enforcement pursuant to Chapter III of Regulation (EU) No 1215/2012, are applicable in the territory of any Member State. No other court shall have such jurisdiction. Article 132 Specific rules on related actions 1. An EU trade mark court hearing an action referred to in Article 124 other than an action for a declaration of non-infringement shall, unless there are special grounds for continuing the hearing, of its own motion after hearing the parties or at the request of one of the parties and after hearing the other parties, stay the proceedings where the validity of the EU trade mark is already in issue before another EU trade mark court on account of a counterclaim or where an application for revocation or for a declaration of invalidity has already been filed at the Office. 2. The Office, when hearing an application for revocation or for a declaration of invalidity shall, unless there are special grounds for continuing the hearing, of its own motion after hearing the parties or at the request of one of the parties and after hearing the other parties, stay the proceedings where the validity of the EU trade mark is already in issue on account of a counterclaim before an EU trade mark court. However, if one of the parties to the proceedings before the EU trade mark court so requests, the court may, after hearing the other parties to these proceedings, stay the proceedings. The Office shall in this instance continue the proceedings pending before it. 3. Where the EU trade mark court stays the proceedings it may order provisional and protective measures for the duration of the stay. Article 133 Jurisdiction of EU trade mark courts of second instance — Further appeal 1. An appeal to the EU trade mark courts of second instance shall lie from judgments of the EU trade mark courts of first instance in respect of proceedings arising from the actions and claims referred to in Article 124. 2. The conditions under which an appeal may be lodged with an EU trade mark court of second instance shall be determined by the national law of the Member State in which that court is located. 3. The national rules concerning further appeal shall be applicable in respect of judgments of EU trade mark courts of second instance. SECTION 3 Other disputes concerning EU trade marks Article 134 Supplementary provisions on the jurisdiction of national courts other than EU trade mark courts 1. Within the Member State whose courts have jurisdiction under Article 122(1) those courts shall have jurisdiction for actions other than those referred to in Article 124, which would have jurisdiction ratione loci and ratione materiae in the case of actions relating to a national trade mark registered in that State. 2. Actions relating to an EU trade mark, other than those referred to in Article 124, for which no court has jurisdiction under Article 122(1) and paragraph 1 of this Article may be heard before the courts of the Member State in which the Office has its seat. Article 135 Obligation of the national court A national court which is dealing with an action relating to an EU trade mark, other than the action referred to in Article 124, shall treat the EU trade mark as valid. CHAPTER XI EFFECTS ON THE LAWS OF THE MEMBER STATES SECTION 1 Civil actions on the basis of more than one trade mark Article 136 Simultaneous and successive civil actions on the basis of EU trade marks and national trade marks 1. Where actions for infringement involving the same cause of action and between the same parties are brought in the courts of different Member States, one seised on the basis of an EU trade mark and the other seised on the basis of a national trade mark: (a) the court other than the court first seised shall of its own motion decline jurisdiction in favour of that court where the trade marks concerned are identical and valid for identical goods or services. The court which would be required to decline jurisdiction may stay its proceedings if the jurisdiction of the other court is contested; (b) the court other than the court first seised may stay its proceedings where the trade marks concerned are identical and valid for similar goods or services and where the trade marks concerned are similar and valid for identical or similar goods or services. 2. The court hearing an action for infringement on the basis of an EU trade mark shall reject the action if a final judgment on the merits has been given on the same cause of action and between the same parties on the basis of an identical national trade mark valid for identical goods or services. 3. The court hearing an action for infringement on the basis of a national trade mark shall reject the action if a final judgment on the merits has been given on the same cause of action and between the same parties on the basis of an identical EU trade mark valid for identical goods or services. 4. Paragraphs 1, 2 and 3 shall not apply in respect of provisional, including protective, measures. SECTION 2 Application of national laws for the purpose of prohibiting the use of EU trade marks Article 137 Prohibition of use of EU trade marks 1. This Regulation shall, unless otherwise provided for, not affect the right existing under the laws of the Member States to invoke claims for infringement of earlier rights within the meaning of Article 8 or Article 60(2) in relation to the use of a later EU trade mark. Claims for infringement of earlier rights within the meaning of Article 8(2) and (4) may, however, no longer be invoked if the proprietor of the earlier right may no longer apply for a declaration that the EU trade mark is invalid in accordance with Article 61(2). 2. This Regulation shall, unless otherwise provided for, not affect the right to bring proceedings under the civil, administrative or criminal law of a Member State or under provisions of Union law for the purpose of prohibiting the use of an EU trade mark to the extent that the use of a national trade mark may be prohibited under the law of that Member State or under Union law. Article 138 Prior rights applicable to particular localities 1. The proprietor of an earlier right which only applies to a particular locality may oppose the use of the EU trade mark in the territory where his right is protected in so far as the law of the Member State concerned so permits. 2. Paragraph 1 shall cease to apply if the proprietor of the earlier right has acquiesced in the use of the EU trade mark in the territory where his right is protected for a period of five successive years, being aware of such use, unless the EU trade mark was applied for in bad faith. 3. The proprietor of the EU trade mark shall not be entitled to oppose use of the right referred to in paragraph 1 even though that right may no longer be invoked against the EU trade mark. SECTION 3 Conversion into a national trade mark application Article 139 Request for the application of national procedure 1. The applicant for or proprietor of an EU trade mark may request the conversion of his EU trade mark application or EU trade mark into a national trade mark application: (a) to the extent that the EU trade mark application is refused, withdrawn, or deemed to be withdrawn; (b) to the extent that the EU trade mark ceases to have effect. 2. Conversion shall not take place: (a) where the rights of the proprietor of the EU trade mark have been revoked on the grounds of non-use, unless in the Member State for which conversion is requested the EU trade mark has been put to use which would be considered to be genuine use under the laws of that Member State; (b) for the purpose of protection in a Member State in which, in accordance with the decision of the Office or of the national court, grounds for refusal of registration or grounds for revocation or invalidity apply to the EU trade mark application or EU trade mark. 3. The national trade mark application resulting from the conversion of an EU trade mark application or an EU trade mark shall enjoy in respect of the Member State concerned the date of filing or the date of priority of that application or trade mark and, where appropriate, the seniority of a trade mark of that State claimed under Articles 39 or 40. 4. In cases where an EU trade mark application is deemed to be withdrawn, the Office shall send to the applicant a communication fixing a period of three months from the date of that communication in which a request for conversion may be filed. 5. Where the EU trade mark application is withdrawn or the EU trade mark ceases to have effect as a result of a surrender being recorded or of failure to renew the registration, the request for conversion shall be filed within three months of the date on which the EU trade mark application has been withdrawn or on which the EU trade mark ceases to have effect. 6. Where the EU trade mark application is refused by decision of the Office or where the EU trade mark ceases to have effect as a result of a decision of the Office or of an EU trade mark court, the request for conversion shall be filed within three months of the date on which that decision acquired the authority of a final decision. 7. The effect referred to in Article 37 shall lapse if the request is not filed in due time. Article 140 Submission, publication and transmission of the request for conversion 1. A request for conversion shall be filed with the Office within the relevant period pursuant to Article 139(4), (5) or (6), and shall include an indication of the grounds for conversion in accordance with Article 139(1)(a) or (b), the Member States in respect of which conversion is requested, and the goods and services subject to conversion. Where conversion is requested following a failure to renew the registration, the period of three months provided for in Article 139(5) shall begin to run on the day following the last day on which the request for renewal can be presented pursuant to Article 53(3). The request for conversion shall not be deemed to be filed until the conversion fee has been paid. 2. Where the request for conversion relates to an EU trade mark application which has already been published or where the request for conversion relates to an EU trade mark, receipt of any such request shall be recorded in the Register and the request for conversion shall be published. 3. The Office shall check whether the conversion requested fulfils the conditions set out in this Regulation, in particular Article 139(1), (2), (4), (5) and (6), and paragraph 1 of this Article, together with the formal conditions specified in the implementing act adopted pursuant to paragraph 6 of this Article. If the conditions governing the request are not fulfilled, the Office shall notify the applicant of the deficiencies. If the deficiencies are not remedied within a period to be specified by the Office, the Office shall reject the request for conversion. Where Article 139(2) applies, the Office shall reject the request for conversion as inadmissible only with respect to those Member States for which conversion is excluded under that provision. Where the conversion fee has not been paid within the relevant period of three months pursuant to Article 139(4), (5) or (6), the Office shall inform the applicant that the request for conversion is deemed not to have been filed. 4. If the Office or an EU trade mark court has refused the EU trade mark application or has declared the EU trade mark invalid on absolute grounds by reference to the language of a Member State, conversion shall be excluded under Article 139(2) for all the Member States in which that language is one of the official languages. If the Office or an EU trade mark court has refused the EU trade mark application or has declared the EU trade mark invalid on absolute grounds which are found to apply throughout the Union or on account of an earlier EU trade mark or other Union industrial property right, conversion shall be excluded under Article 139(2) for all Member States. 5. Where the request for conversion complies with the requirements referred to in paragraph 3 of this Article, the Office shall transmit the request for conversion and the data referred to in Article 111(2) to the central industrial property offices of the Member States, including the Benelux Office for Intellectual Property, for which the request has been found admissible. The Office shall inform the applicant of the date of transmission. 6. The Commission shall adopt implementing acts specifying: (a) the details to be contained in a request for conversion of an EU trade mark application or a registered EU trade mark into a national trade mark application pursuant to paragraph 1; (b) the details which are to be contained in the publication of the request for conversion pursuant to paragraph 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 141 Formal requirements for conversion 1. Any central industrial property office to which the request for conversion is transmitted may obtain from the Office any additional information concerning the request enabling that office to make a decision regarding the national trade mark resulting from the conversion. 2. An EU trade mark application or an EU trade mark transmitted in accordance with Article 140 shall not be subject to formal requirements of national law which are different from or additional to those provided for in this Regulation or in acts adopted pursuant to this Regulation. 3. Any central industrial property office to which the request is transmitted may require that the applicant shall, within not less than two months: (a) pay the national application fee; (b) file a translation in one of the official languages of the State in question of the request and of the documents accompanying it; (c) indicate an address for service in the State in question; (d) supply a representation of the trade mark in the number of copies specified by the State in question. CHAPTER XII THE OFFICE SECTION 1 General provisions Article 142 Legal status 1. The Office shall be an agency of the Union. It shall have legal personality. 2. In each of the Member States the Office shall enjoy the most extensive legal capacity accorded to legal persons under their laws; it may, in particular, acquire or dispose of movable and immovable property and may be a party to legal proceedings. 3. The Office shall be represented by its Executive Director. Article 143 Staff 1. The Staff Regulations, the Conditions of Employment and the rules adopted by agreement between the institutions of the Union for giving effect to those Staff Regulations and Conditions of Employment shall apply to the staff of the Office, without prejudice to the application of Article 166 of this Regulation to the members of the Boards of Appeal. 2. Without prejudice to paragraph 1, the Office may make use of seconded national experts or other staff not employed by the Office. The Management Board shall adopt a decision laying down rules on the secondment to the Office of national experts. Article 144 Privileges and immunities The Protocol on the Privileges and Immunities of the Union shall apply to the Office and its staff. Article 145 Liability 1. The contractual liability of the Office shall be governed by the law applicable to the contract in question. 2. The Court of Justice shall be competent to give judgment pursuant to any arbitration clause contained in a contract concluded by the Office. 3. In the case of non-contractual liability, the Office shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its departments or by its servants in the performance of their duties. 4. The Court of Justice shall have jurisdiction in disputes relating to compensation for the damage referred to in paragraph 3. 5. The personal liability of its servants towards the Office shall be governed by the provisions laid down in the Staff Regulations or in the Conditions of Employment applicable to them. Article 146 Languages 1. The application for an EU trade mark shall be filed in one of the official languages of the Union. 2. The languages of the Office shall be English, French, German, Italian and Spanish. 3. The applicant shall indicate a second language which shall be a language of the Office the use of which he accepts as a possible language of proceedings for opposition, revocation or invalidity proceedings. If the application was filed in a language which is not one of the languages of the Office, the Office shall arrange to have the application, as described in Article 31(1), translated into the language indicated by the applicant. 4. Where the applicant for an EU trade mark is the sole party to proceedings before the Office, the language of proceedings shall be the language used for filing the application for an EU trade mark. If the application was made in a language other than the languages of the Office, the Office may send written communications to the applicant in the second language indicated by the applicant in his application. 5. The notice of opposition and an application for revocation or a declaration of invalidity shall be filed in one of the languages of the Office. 6. Without prejudice to paragraph 5: (a) any application or declaration relating to an EU trade mark application may be filed in the language used for filing the application for that EU trade mark or in the second language indicated by the applicant in his application; (b) any application or declaration relating to a registered EU trade mark may be filed in one of the languages of the Office. However, when the application is filed by using any form provided by the Office as referred to in Article 100(2), such forms may be used in any of the official languages of the Union, provided that the form is completed in one of the languages of the Office, as far as textual elements are concerned. 7. If the language chosen, in accordance with paragraph 5, for the notice of opposition or the application for revocation or invalidity is the language of the application for a trade mark or the second language indicated when the application was filed, that language shall be the language of the proceedings. If the language chosen, in accordance with paragraph 5, for the notice of opposition or the application for revocation or invalidity is neither the language of the application for a trade mark nor the second language indicated when the application was filed, the opposing party or the party seeking revocation or invalidity shall be required to produce, at his own expense, a translation of his application either into the language of the application for a trade mark, provided that it is a language of the Office, or into the second language indicated when the application was filed. The translation shall be produced within one month of the expiry of the opposition period or of the date of filing an application for revocation or a declaration of invalidity. The language into which the application has been translated shall then become the language of the proceedings. 8. Parties to opposition, revocation, invalidity or appeal proceedings may agree that a different official language of the Union is to be the language of the proceedings. 9. Without prejudice to paragraphs 4 and 8, and unless provided otherwise, in written proceedings before the Office any party may use any language of the Office. If the language chosen is not the language of the proceedings, the party shall supply a translation into that language within one month of the date of the submission of the original document. Where the applicant for an EU trade mark is the sole party to proceedings before the Office and the language used for the filing of the application for the EU trade mark is not one of the languages of the Office, the translation may also be filed in the second language indicated by the applicant in his application. 10. The Executive Director shall determine the manner in which translations are to be certified. 11. The Commission shall adopt implementing acts specifying: (a) the extent to which supporting documents to be used in written proceedings before the Office may be filed in any language of the Union, and the need to supply a translation; (b) the requisite standards of translations to be filed with the Office. Those implementing acts shall be adopted in accordance with the examination procedure referred to Article 207(2). Article 147 Publication and entries in the Register 1. An application for an EU trade mark, as described in Article 31(1), and all other information the publication of which is prescribed by this Regulation or an act adopted pursuant to this Regulation, shall be published in all the official languages of the Union. 2. All entries in the Register shall be made in all the official languages of the Union. 3. In cases of doubt, the text in the language of the Office in which the application for the EU trade mark was filed shall be authentic. If the application was filed in an official language of the Union other than one of the languages of the Office, the text in the second language indicated by the applicant shall be authentic. Article 148 Translation services The translation services required for the functioning of the Office shall be provided by the Translation Centre for the Bodies of the European Union. Article 149 Transparency 1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council (16) shall apply to documents held by the Office. 2. The Management Board shall adopt detailed rules for applying Regulation (EC) No 1049/2001. 3. Decisions taken by the Office under Article 8 of Regulation (EC) No 1049/2001 may be challenged through the European Ombudsman or form the subject of an action before the Court of Justice of the European Union, under the conditions laid down in Articles 228 and 263 TFEU respectively. 4. The processing of personal data by the Office shall be subject to Regulation (EC) No 45/2001 of the European Parliament and of the Council (17). Article 150 Security rules on the protection of classified and sensitive non-classified information The Office shall apply the security principles contained in the Commission's security rules for protecting European Union Classified Information (EUCI) and sensitive non-classified information, as set out in Commission Decisions (EU, Euratom) 2015/443 (18) and 2015/444 (19). The security principles shall cover, inter alia, provisions for the exchange, processing and storage of such information. SECTION 2 Tasks of the office and cooperation to promote convergence Article 151 Tasks of the Office 1. The Office shall have the following tasks: (a) administration and promotion of the EU trade mark system established in this Regulation; (b) administration and promotion of the European Union design system established in Council Regulation (EC) No 6/2002 (20); (c) promoting convergence of practices and tools in the fields of trade marks and designs, in cooperation with the central industrial property offices in the Member States, including the Benelux Office for Intellectual Property; (d) the tasks referred to in Regulation (EU) No 386/2012 of the European Parliament and of the Council (21); (e) the tasks conferred on it under Directive 2012/28/EU of the European Parliament and of the Council (22). 2. The Office shall cooperate with institutions, authorities, bodies, industrial property offices, international and non-governmental organisations in relation to the tasks conferred on it in paragraph 1. 3. The Office may provide voluntary mediation services for the purpose of assisting parties in reaching a friendly settlement. Article 152 Cooperation to promote convergence of practices and tools 1. The Office and the central industrial property offices of the Member States and the Benelux Office for Intellectual Property shall cooperate with each other to promote convergence of practices and tools in the field of trade marks and designs. Without prejudice to paragraph 3, this cooperation shall in particular cover the following areas of activity: (a) the development of common examination standards; (b) the creation of common or connected databases and portals for Union-wide consultation, search and classification purposes; (c) the continuous provision and exchange of data and information, including for the purposes of feeding of the databases and portals referred to in point (b); (d) the establishment of common standards and practices, with a view to ensuring interoperability between procedures and systems throughout the Union and enhancing their consistency, efficiency and effectiveness; (e) the sharing of information on industrial property rights and procedures, including mutual support to helpdesks and information centres; (f) the exchange of technical expertise and assistance in relation to the areas referred to in points (a) to (e). 2. On the basis of a proposal by the Executive Director, the Management Board shall define and coordinate projects of interest to the Union and the Member States with regard to the areas referred to in paragraphs 1 and 6, and shall invite the central industrial property offices of the Member States and the Benelux Office for Intellectual Property to participate in those projects. The project definition shall contain the specific obligations and responsibilities of each participating industrial property office of the Member States, the Benelux Office for Intellectual Property and the Office. The Office shall consult with user representatives in particular in the phases of definition of the projects and evaluation of their results. 3. The central industrial property offices of the Member States and the Benelux Office for Intellectual Property may opt out of, restrict or temporarily suspend their cooperation in the projects referred to in the first subparagraph of paragraph 2. When making use of the possibilities provided for in the first subparagraph, the central industrial property offices of the Member States and the Benelux Office for Intellectual Property shall provide the Office with a written statement explaining the reasons for their decision. 4. Once having committed to participate in certain projects, the central industrial property offices of the Member States and the Benelux Office for Intellectual Property shall, without prejudice to paragraph 3, participate effectively in the projects referred to in paragraph 2 with a view to ensuring that they are developed, function, are interoperable and kept up to date. 5. The Office shall provide financial support to the projects referred to in paragraph 2 to the extent that is necessary in order to ensure, for the purposes of paragraph 4, the effective participation of the central industrial property offices of the Member States and the Benelux Office for Intellectual Property in those projects. That financial support may take the form of grants and in-kind contributions. The total amount of funding shall not exceed 15 % of the yearly revenue of the Office. The beneficiaries of grants shall be the central industrial property offices of the Member States and the Benelux Office for Intellectual Property. Grants may be awarded without calls for proposals in accordance with the financial rules applicable to the Office and with the principles of grant procedures contained in Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (23) and in Commission Delegated Regulation (EU) No 1268/2012 (24). 6. The Office and the relevant competent authorities of the Member States shall cooperate with each other on a voluntary basis to promote the raising of awareness concerning the trade mark system and the fight against counterfeiting. Such cooperation shall include projects aiming, in particular, at the implementation of established standards and practices as well as at organising education and training activities. The financial support for those projects shall be part of the total amount of funding referred to in paragraph 5. Paragraphs 2 to 5 shall apply mutatis mutandis. SECTION 3 Management Board Article 153 Functions of the Management Board 1. Without prejudice to the functions attributed to the Budget Committee in Section 6, the Management Board shall have the following functions: (a) on the basis of a draft submitted by the Executive Director in accordance with Article 157(4)(c), adopting the annual work programme of the Office for the coming year, taking into account the opinion of the Commission, and forwarding the adopted annual work programme to the European Parliament, to the Council and to the Commission; (b) on the basis of a draft submitted by the Executive Director in accordance with Article 157(4)(e) and taking into account the opinion of the Commission, adopting a multiannual strategic programme for the Office, including the Office's strategy for international cooperation, following an exchange of views between the Executive Director and the relevant committee in the European Parliament, and forwarding the adopted multiannual strategic programme to the European Parliament, to the Council and to the Commission; (c) on the basis of a draft submitted by the Executive Director in accordance with Article 157(4)(g), adopting the annual report and forwarding the adopted annual report to the European Parliament, to the Council, to the Commission and to the Court of Auditors; (d) on the basis of a draft submitted by the Executive Director in accordance with Article 157(4)(h), adopting the multiannual staff policy plan; (e) exercising the powers conferred on it under Article 152(2); (f) exercising the powers conferred on it under Article 172(5); (g) adopting rules on the prevention and management of conflicts of interest in the Office; (h) in accordance with paragraph 2, exercising, with respect to the staff of the Office, the powers conferred by the Staff Regulations on the Appointing Authority and by the Conditions of Employment on the Authority Empowered to Conclude Contracts of Employment (‘the appointing authority powers’); (i) adopting appropriate implementing rules to give effect to the Staff Regulations and the Conditions of Employment in accordance with Article 110 of the Staff Regulations; (j) drawing up the list of candidates provided for in Article 158(2); (k) ensuring adequate follow-up to the findings and recommendations stemming from the internal or external audit reports and evaluations referred to in Article 210, as well as from investigations of the European Anti-fraud Office (OLAF); (l) being consulted before adoption of the guidelines for examination in the Office and in the other cases provided for in this Regulation; (m) providing opinions and requests for information to the Executive Director and to the Commission where it considers it necessary. 2. The Management Board shall adopt, in accordance with Article 110 of the Staff Regulations and Article 142 of the Conditions of Employment, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment, delegating the relevant appointing authority powers to the Executive Director and defining the conditions under which that delegation of appointing authority powers can be suspended. The Executive Director shall be authorised to sub-delegate those powers. Where exceptional circumstances so require, the Management Board may, by way of a decision, temporarily suspend the delegation of the appointing authority powers to the Executive Director and those sub-delegated by the latter, and exercise them itself or delegate them to one of its members or to a staff member other than the Executive Director. Article 154 Composition of the Management Board 1. The Management Board shall be composed of one representative of each Member State, two representatives of the Commission and one representative of the European Parliament, and their respective alternates. 2. The members of the Management Board may, subject to its rules of procedure, be assisted by advisers or experts. Article 155 Chairperson of the Management Board 1. The Management Board shall elect a chairperson and a deputy chairperson from among its members. The deputy chairperson shall ex officio replace the chairperson in the event of his being prevented from attending to his duties. 2. The duration of the terms of office of the chairperson and the deputy chairperson shall be four years. The terms of office shall be renewable once. If, however, their membership of the Management Board ends at any time during their term of office, their term of office shall automatically expire on that date also. Article 156 Meetings 1. Meetings of the Management Board shall be convened by its chairperson. 2. The Executive Director shall take part in the deliberations, unless the Management Board decides otherwise. 3. The Management Board shall hold an ordinary meeting at least once a year. In addition, it shall meet on the initiative of its chairperson or at the request of the Commission or of one-third of the Member States. 4. The Management Board shall adopt rules of procedure. 5. The Management Board shall take its decisions by an absolute majority of its members. However, a majority of two-thirds of its members shall be required for the decisions which the Management Board is empowered to take under Article 153(1)(a) and (b), Article 155(1) and Article 158(2) and (4). In both cases each member shall have one vote. 6. The Management Board may invite observers to attend its meetings. 7. The secretariat for the Management Board shall be provided by the Office. SECTION 4 Executive Director Article 157 Functions of the Executive Director 1. The Office shall be managed by the Executive Director. The Executive Director shall be accountable to the Management Board. 2. Without prejudice to the powers of the Commission, the Management Board, and the Budget Committee, the Executive Director shall be independent in the performance of his duties and shall neither seek nor take instructions from a government or from any other body. 3. The Executive Director shall be the legal representative of the Office. 4. The Executive Director shall have in particular the following functions, which may be delegated: (a) taking all necessary steps, including the adoption of internal administrative instructions and the publication of notices, to ensure the functioning of the Office; (b) implementing the decisions adopted by the Management Board; (c) preparing a draft annual work programme indicating estimated human and financial resources for each activity, and submitting it to the Management Board after consultation of the Commission; (d) submitting to the Management Board proposals pursuant to Article 152(2); (e) preparing a draft multiannual strategic programme, including the Office's strategy for international cooperation, and submitting it to the Management Board after consultation of the Commission and following an exchange of views with the relevant committee in the European Parliament; (f) implementing the annual work programme and the multiannual strategic programme and reporting to the Management Board on their implementation; (g) preparing the annual report on the Office's activities and presenting it to the Management Board for approval; (h) preparing a draft multiannual staff policy plan and submitting it to the Management Board after consultation of the Commission; (i) preparing an action plan following-up on the conclusions of the internal or external audit reports and evaluations, as well as following up on the investigations of the OLAF, and reporting on progress twice a year to the Commission and to the Management Board; (j) protecting the financial interests of the Union by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by recovering amounts wrongly paid and, where appropriate, by imposing effective, proportionate and dissuasive administrative and financial penalties; (k) preparing an anti-fraud strategy for the Office and presenting it to the Budget Committee for approval; (l) in order to ensure uniform application of the Regulation, referring, where appropriate, to the enlarged Board of Appeal (‘the Grand Board’) questions on a point of law, in particular if the Boards of Appeal have issued diverging decisions on the point; (m) drawing up estimates of the revenue and expenditure of the Office and implementing the budget; (n) exercising the powers entrusted to him in respect of staff by the Management Board under Article 153(1)(h); (o) exercising the powers conferred on him under Articles 31(3), 34(5), 35(3), 94(2), 97(5), Articles 98, 100, 101, Articles 111(4), 112(3), 114(5), Articles 115, 116, Articles 120(4), 146(10), Article 178, Articles 179(1) and 180(2), and Article 181 in accordance with the criteria set out in this Regulation and in the acts adopted pursuant to this Regulation. 5. The Executive Director shall be assisted by one or more Deputy Executive Directors. If the Executive Director is absent or indisposed, the Deputy Executive Director or one of the Deputy Executive Directors shall replace him in accordance with the procedure laid down by the Management Board. Article 158 Appointment and removal of the Executive Director and extension of term of office 1. The Executive Director shall be engaged as a temporary agent of the Office under Article 2(a) of the Conditions of Employment. 2. The Executive Director shall be appointed by the Council by simple majority, from a list of candidates proposed by the Management Board, following an open and transparent selection procedure. Before being appointed, the candidate selected by the Management Board may be invited to make a statement before any competent European Parliament committee and to answer questions put by its members. For the purpose of concluding the contract with the Executive Director, the Office shall be represented by the chairperson of the Management Board. The Executive Director may be removed from office only upon a decision of the Council acting on a proposal from the Management Board. 3. The term of office of the Executive Director shall be five years. By the end of that period, the Management Board shall undertake an assessment which takes into account an evaluation of the performance of the Executive Director and the Office's future tasks and challenges. 4. The Council, taking into account the assessment referred to in paragraph 3, may extend the term of office of the Executive Director once and for no more than five years. 5. An Executive Director whose term of office has been extended may not participate in another selection procedure for the same post at the end of his overall term of office. 6. The Deputy Executive Director or Deputy Executive Directors shall be appointed or removed from office as provided for in paragraph 2, after consultation of the Executive Director and, where applicable, the Executive Director-elect. The term of office of the Deputy Executive Director shall be five years. It may be extended once and for no more than five years by the Council, after consultation of the Executive Director. SECTION 5 Implementation of procedures Article 159 Competence For taking decisions in connection with the procedures laid down in this Regulation, the following shall be competent: (a) examiners; (b) Opposition Divisions; (c) a department in charge of the Register; (d) Cancellation Divisions; (e) Boards of Appeal; (f) any other unit or person appointed by the Executive Director to that effect. Article 160 Examiners An examiner shall be responsible for taking decisions on behalf of the Office in relation to an application for registration of an EU trade mark, including the matters referred to in Articles 41, 42, 76 and 85, except in so far as an Opposition Division is responsible. Article 161 Opposition Divisions 1. An Opposition Division shall be responsible for taking decisions on an opposition to an application to register an EU trade mark. 2. The decisions of the Opposition Divisions shall be taken by three-member groups. At least one member shall be legally qualified. Decisions relating to costs or to procedures shall be taken by a single member. The Commission shall adopt implementing acts specifying the exact types of decisions that are to be taken by a single member. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 162 Department in charge of the Register 1. The Department in charge of the Register shall be responsible for taking decisions in respect of entries in the Register. 2. It shall also be responsible for keeping the list of professional representatives referred to in Article 120(2). 3. The decisions of the Department shall be taken by a single member. Article 163 Cancellation Divisions 1. A Cancellation Division shall be responsible for taking decisions in relation to: (a) applications for the revocation or a declaration of invalidity of an EU trade mark; (b) requests for the assignment of an EU trade mark as provided for in Article 21. 2. The decisions of the Cancellation Divisions shall be taken by three-member groups. At least one member shall be legally qualified. Decisions relating to costs or to procedures as specified in the acts adopted pursuant to Article 161(2) shall be taken by a single member. Article 164 General Competence Decisions required under this Regulation which do not fall within the competence of an examiner, an Opposition Division, a Cancellation Division or the Department in charge of the Register, shall be taken by any official or unit appointed by the Executive Director for that purpose. Article 165 Boards of Appeal 1. The Boards of Appeal shall be responsible for deciding on appeals from decisions taken pursuant to Articles 160 to 164. 2. The decisions of the Boards of Appeal shall be taken by three members, at least two of whom are legally qualified. In certain specific cases, decisions shall be taken by the Grand Board chaired by the President of the Boards of Appeal or by a single member, who shall be legally qualified. 3. In order to determine the special cases which fall under the jurisdiction of the Grand Board, account should be taken of the legal difficulty or the importance of the case or of special circumstances which justify it. Such cases may be referred to the Grand Board: (a) by the authority of the Boards of Appeal referred to in Article 166(4)(a); or (b) by the Board handling the case. 4. The Grand Board shall also be responsible for giving reasoned opinions on questions of law referred to it by the Executive Director pursuant to Article 157(4)(l). 5. To determine which specific cases fall under the authority of a single member, account should be taken of the lack of difficulty of the legal or factual matters raised, the limited importance of the individual case or the absence of other specific circumstances. The decision to confer a case on one member in the cases referred to shall be adopted by the Board handling the case. Article 166 Independence of the members of the Boards of Appeal 1. The President of the Boards of Appeal and the chairpersons of the Boards shall be appointed, in accordance with the procedure laid down in Article 158 for the appointment of the Executive Director, for a term of five years. They shall not be removed from office during this term, unless there are serious grounds for such removal and the Court of Justice, on application by the institution which appointed them, takes a decision to this effect. 2. The term of office of the President of the Boards of Appeal may be extended once for one additional five-year period, or until retirement age if this age is reached during the new term of office, after a prior positive evaluation of his performance by the Management Board. 3. The term of office of the chairpersons of the Boards may be extended for additional five-year periods, or until retirement age if this age is reached during the new term of office, after a prior positive evaluation of their performance by the Management Board, and after consulting the President of the Boards of Appeal. 4. The President of the Boards of Appeal shall have the following managerial and organisational functions: (a) chairing the Presidium of the Boards of Appeal (‘the Presidium’), responsible for laying down the rules and organising the work of the Boards; (b) ensuring the implementation of the decisions of the Presidium; (c) allocating cases to a Board on the basis of objective criteria determined by the Presidium; (d) forwarding to the Executive Director the Boards' expenditure requirements, with a view to drawing up the expenditure estimates. The President of the Boards of Appeal shall chair the Grand Board. 5. The members of the Boards of Appeal shall be appointed by the Management Board for a term of five years. Their term of office may be extended for additional five-year periods, or until retirement age if that age is reached during the new term of office after a prior positive evaluation of their performance by the Management Board, and after consulting the President of the Boards of Appeal. 6. The members of the Boards of Appeal shall not be removed from office unless there are serious grounds for such removal and the Court of Justice, after the case has been referred to it by the Management Board on the recommendation of the President of the Boards of Appeal, and after consulting the chairperson of the Board to which the member concerned belongs, takes a decision to this effect. 7. The President of the Boards of Appeal and the chairpersons and members of the Boards of Appeal shall be independent. In their decisions, they shall not be bound by any instructions. 8. Decisions taken by the Grand Board on appeals or opinions on questions of law referred to it by the Executive Director pursuant to Article 165 shall be binding on the decision-making instances of the Office listed in Article 159. 9. The President of the Boards of Appeal and the chairpersons and members of the Boards of Appeal shall not be examiners or members of the Opposition Divisions, the Department in charge of the Register or Cancellation Divisions. Article 167 Presidium of the Boards of Appeal and Grand Board 1. The Presidium shall comprise the President of the Boards of Appeal, who shall chair it, the chairmen of the Boards and Board members elected for each calendar year by and from among all the members of the Boards other than the President of the Boards of Appeal and the chairmen of the Boards. The number of Board members so elected shall constitute a quarter of the number of Board members, other than the President of the Boards of Appeal and the chairmen of the Boards, and that number shall be rounded up if necessary. 2. The Grand Board referred to in Article 165(2) shall comprise nine members, including the President of the Boards of Appeal, the chairmen of the Boards, the rapporteur designated prior to referral to the Grand Board, if applicable, and members drawn in rotation from a list comprising the names of all members of the Boards of Appeal other than the President of the Boards of Appeal and the chairmen of the Boards. Article 168 Delegation of powers The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the details concerning the organisation of the Boards of Appeal, including the setting up and the role of the Presidium, the composition of the Grand Board and the rules on referrals to it, and the conditions under which decisions are to be taken by a single member in accordance with Article 165(2) and (5). Article 169 Exclusion and objection 1. Examiners and members of the Divisions set up within the Office or of the Boards of Appeal may not take part in any proceedings if they have any personal interest therein, or if they have previously been involved as representatives of one of the parties. Two of the three members of an Opposition Division shall not have taken part in examining the application. Members of the Cancellation Divisions may not take part in any proceedings if they have participated in the final decision on the case in the proceedings for registration or opposition proceedings. Members of the Boards of Appeal may not take part in appeal proceedings if they participated in the decision under appeal. 2. If, for one of the reasons mentioned in paragraph 1 or for any other reason, a member of a Division or of a Board of Appeal considers that he should not take part in any proceedings, he shall inform the Division or Board accordingly. 3. Examiners and members of the Divisions or of a Board of Appeal may be objected to by any party for one of the reasons mentioned in paragraph 1, or if suspected of partiality. An objection shall not be admissible if, while being aware of a reason for objection, the party has taken a procedural step. No objection may be based upon the nationality of examiners or members. 4. The Divisions and the Boards of Appeal shall decide as to the action to be taken in the cases specified in paragraphs 2 and 3 without the participation of the member concerned. For the purposes of taking this decision the member who withdraws or has been objected to shall be replaced in the Division or Board of Appeal by his alternate. Article 170 Mediation centre 1. For the purposes of Article 151(3), the Office may establish a Mediation Centre (‘the Centre’). 2. Any natural or legal person may use the Centre's services on a voluntary basis with the aim of reaching a friendly settlement of disputes, based on this Regulation or Regulation (EC) No 6/2002, by mutual agreement. 3. The parties shall have recourse to mediation by means of a joint request. The request shall not be deemed to have been filed until the corresponding charge has been paid. The Executive Director shall fix the amount to be charged in accordance with Article 178(1). 4. In the case of disputes subject to the proceedings pending before the Opposition Divisions, Cancellation Divisions or before the Boards of Appeal of the Office a joint request for mediation may be presented at any time after the lodging of a notice of opposition, an application for revocation or an application for a declaration of invalidity or a notice of appeal against decisions of the Opposition or Cancellation Divisions. 5. The proceedings in question shall be suspended and the time periods, other than the time periods for the payment of the applicable fee, shall be interrupted as from the date of the filing of a joint request for mediation. The time periods shall continue as from the day on which the proceedings are resumed. 6. The parties shall be invited to jointly appoint, from the list referred to in paragraph 12, a mediator who has declared that he has a command of the language of the mediation in question. Where the parties do not appoint a mediator within 20 days of the invitation to do so, the mediation shall be deemed to have failed. 7. The parties shall agree together with the mediator on the detailed arrangements for the mediation in a mediation agreement. 8. The mediator shall conclude the mediation proceedings as soon as the parties reach a settlement agreement, or one of the parties declares that it wishes to end the mediation or the mediator establishes that the parties have failed to reach such an agreement. 9. The mediator shall inform the parties as well as the relevant instance of the Office as soon as the mediation proceedings have been concluded. 10. The discussions and negotiations conducted within the framework of mediation shall be confidential for all persons involved in the mediation, in particular for the mediator, the parties and their representatives. All documents and information submitted during the mediation shall be kept separately from, and shall not be part of, the file of any other proceedings before the Office. 11. The mediation shall be conducted in one of the official languages of the Union to be agreed upon by the parties. Where the mediation relates to disputes pending before the Office, the mediation shall be conducted in the language of the Office proceedings, unless otherwise agreed by the parties. 12. The Office shall establish a list of mediators who shall support parties in resolving disputes. The mediators shall be independent and possess relevant skills and experience. The list may include mediators who are employed by the Office, and mediators who are not so employed. 13. Mediators shall be impartial in the exercise of their duties and shall declare any real or perceived conflict of interest upon their designation. Members of the decision-making instances of the Office listed in Article 159 shall not take part in mediation concerning a case in which they have: (a) had any prior involvement in the proceedings referred to mediation; (b) any personal interest in those proceedings; or (c) been previously involved as a representative of one of the parties. 14. Mediators shall not take part as members of the decision-making instances of the Office listed in Article 159 in proceedings resumed as a consequence of a mediation failure. 15. The Office may cooperate with other recognised national or international bodies dealing with mediation. SECTION 6 Budget and financial control Article 171 Budget Committee 1. The Budget Committee shall have the functions assigned to it in this Section. 2. Articles 154 and 155, Article 156(1) to (4), and (5), in so far as it relates to the election of the chairperson and deputy chairperson, and Article 156(6) and (7) shall apply to the Budget Committee, mutatis mutandis. 3. The Budget Committee shall take its decisions by an absolute majority of its members. However, a majority of two-thirds of its members shall be required for the decisions which the Budget Committee is empowered to take under Article 173(3) and Article 177. In both cases each member shall have one vote. Article 172 Budget 1. Estimates of all the Office's revenue and expenditure shall be prepared for each financial year and shall be shown in the Office's budget. Each financial year shall correspond to the calendar year. 2. The revenue and expenditure shown in the budget shall be in balance. 3. Revenue shall comprise, without prejudice to other types of income, total fees payable under Annex I to this Regulation, total fees as provided for in Regulation (EC) No 6/2002, total fees payable, under the Madrid Protocol, for an international registration designating the Union, and other payments made to Contracting Parties to the Madrid Protocol, total fees payable, under the Geneva Act referred to in Article 106c of Regulation (EC) No 6/2002, for an international registration designating the Union and other payments made to Contracting Parties to the Geneva Act, and, to the extent necessary, a subsidy entered against a specific heading of the Commission section of the general budget of the Union. 4. Every year the Office shall offset the costs incurred by the central industrial property offices of the Member States, by the Benelux Office for Intellectual Property and by any other relevant authority to be nominated by a Member State, as the result of the specific tasks which they carry out as functional parts of the EU trade mark system in the context of the following services and procedures: (a) opposition and invalidity proceedings before the central industrial property offices of the Member States and the Benelux Office for Intellectual Property involving EU trade marks; (b) provision of information on the functioning of the EU trade mark system through helpdesks and information centres; (c) enforcement of EU trade marks, including action taken pursuant to Article 9(4). 5. The overall offsetting of the costs identified in paragraph 4 shall correspond to 5 % of the yearly revenue of the Office. Without prejudice to the third subparagraph of this paragraph, on a proposal by the Office and after having consulted the Budget Committee, the Management Board shall determine the distribution key on the basis of the following fair, equitable and relevant indicators: (a) the annual number of EU trade mark applications originating from applicants in each Member State; (b) the annual number of national trade mark applications in each Member State; (c) the annual number of oppositions and applications for a declaration of invalidity submitted by proprietors of EU trade marks in each Member State; (d) the annual number of cases brought before the EU trade mark courts designated by each Member State in accordance with Article 123. For the purpose of substantiating the costs referred to in paragraph 4, Member States shall submit to the Office by 31 March of each year, statistical data demonstrating the figures referred to in points (a) to (d) of the first subparagraph of this paragraph for the preceding year, which shall be included in the proposal to be made to the Management Board. On grounds of equity, the costs incurred by the bodies referred to in paragraph 4 in each Member State shall be deemed to correspond to at least 2 % of the total offsetting provided for under this paragraph. 6. The obligation by the Office to offset the costs referred to in paragraph 4 and incurred in a given year shall only apply to the extent that no budgetary deficit occurs in that year. 7. In the event of a budgetary surplus, and without prejudice to paragraph 10, on a proposal by the Office and after having consulted the Budget Committee, the Management Board may increase the percentage laid down in paragraph 5 to a maximum of 10 % of the yearly revenue of the Office. 8. Without prejudice to paragraphs 4 to 7 and paragraph 10 of this Article and to Articles 151 and 152, where a substantive surplus is generated over five consecutive years, the Budget Committee, upon a proposal from the Office and in accordance with the annual work programme and multiannual strategic programme referred to in Article 153(1)(a) and (b), shall decide by a two-thirds majority on the transfer to the budget of the Union of a surplus generated from 23 March 2016. 9. The Office shall prepare on a biannual basis a report for the European Parliament, the Council and the Commission on its financial situation, including on the financial operations performed under Article 152(5) and (6), and paragraphs 5 and 7 of this Article. On the basis of that report, the Commission shall review the financial situation of the Office. 10. The Office shall provide for a reserve fund covering one year of its operational expenditure to ensure the continuity of its operations and the execution of its tasks. Article 173 Preparation of the budget 1. The Executive Director shall draw up each year an estimate of the Office's revenue and expenditure for the following year and shall send it to the Budget Committee not later than 31 March in each year, together with a list of posts. 2. Should the budget estimates provide for a Union subsidy, the Budget Committee shall immediately forward the estimate to the Commission, which shall forward it to the budget authority of the Union. The Commission may attach an opinion on the estimate along with an alternative estimate. 3. The Budget Committee shall adopt the budget, which shall include the Office's list of posts. Should the budget estimates contain a subsidy from the general budget of the Union, the Office's budget shall, if necessary, be adjusted. Article 174 Audit and control 1. An internal audit function shall be set up within the Office, to be performed in compliance with the relevant international standards. The internal auditor, appointed by the Executive Director, shall be responsible to him for verifying the proper operation of budget implementation systems and procedures of the Office. 2. The internal auditor shall advise the Executive Director on dealing with risks, by issuing independent opinions on the quality of management and control systems and by issuing recommendations for improving the conditions of implementation of operations and promoting sound financial management. 3. The responsibility for putting in place internal control systems and procedures suitable for carrying out his tasks shall lie with the authorising officer. Article 175 Combating fraud 1. In order to facilitate combating fraud, corruption and other unlawful activities under Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (25), the Office shall accede to the Inter-institutional Agreement of 25 May 1999 concerning internal investigations by OLAF, and adopt the appropriate provisions applicable to all the employees of the Office using the template set out in the Annex to that Agreement. 2. The Court of Auditors shall have the power of audit, on the basis of documents and on the spot, over all grant beneficiaries, contractors and subcontractors who have received Union funds from the Office. 3. OLAF may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 and Council Regulation (Euratom, EC) No 2185/96 (26) with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union in connection with a grant or a contract funded by the Office. 4. Without prejudice to paragraphs 1, 2 and 3, cooperation agreements with third countries and international organisations, contracts, grant agreements and grant decisions of the Office shall contain provisions expressly empowering the Court of Auditors and OLAF to conduct such audits and investigations, in accordance with their respective competences. 5. The Budget Committee shall adopt an anti-fraud strategy which is proportionate to the fraud risks having regard to the cost-benefit of the measures to be implemented. Article 176 Auditing of accounts 1. Not later than 31 March in each year the Executive Director shall transmit to the Commission, the European Parliament, the Budget Committee and the Court of Auditors accounts of the Office's total revenue and expenditure for the preceding financial year. The Court of Auditors shall examine them in accordance with Article 287 TFEU. 2. The Budget Committee shall give a discharge to the Executive Director in respect of the implementation of the budget. Article 177 Financial provisions The Budget Committee shall, after consulting the Court of Auditors and the Commission, adopt internal financial provisions specifying, in particular, the procedure for establishing and implementing the Office's budget. As far as is compatible with the particular nature of the Office, the financial provisions shall be based on the financial regulations adopted for other bodies set up by the Union. Article 178 Fees and charges and due date 1. The Executive Director shall lay down the amount to be charged for any services rendered by the Office other than those set out in Annex I, as well as the amount to be charged for the European Union Trade Marks Bulletin, the Official Journal of the Office and any other publications issued by the Office. The amounts of charges shall be set in euros and shall be published in the Official Journal of the Office. The amount of each charge shall not exceed what is necessary to cover the costs of the specific service rendered by the Office. 2. Fees and charges in respect of which the due date is not specified in this Regulation shall be due on the date of receipt of the request for the service for which the fee or the charge is incurred. With the consent of the Budget Committee, the Executive Director may determine which of the services mentioned in the first subparagraph are not to be dependent upon the advance payment of the corresponding fees or charges. Article 179 Payment of fees and charges 1. Fees and charges due to the Office shall be paid by payment or transfer to a bank account held by the Office. With the consent of the Budget Committee, the Executive Director may establish which specific methods of payment other than those set out in the first subparagraph, in particular by means of deposits in current accounts held with the Office, may be used. Determinations made pursuant to the second subparagraph shall be published in the Official Journal of the Office. All payments, including by any other method of payment established pursuant to the second subparagraph, shall be made in euros. 2. Every payment shall indicate the name of the person making the payment and shall contain the necessary information to enable the Office to establish immediately the purpose of the payment. In particular, the following information shall be provided: (a) when the application fee is paid, the purpose of the payment, namely ‘application fee’; (b) when the opposition fee is paid, the file number of the application and the name of the applicant for the EU trade mark against which opposition is entered, and the purpose of the payment, namely ‘opposition fee’; (c) when the revocation fee and the invalidity fee are paid, the registration number and the name of the proprietor of the EU trade mark against which the application is directed, and the purpose of the payment, namely ‘revocation fee’ or ‘invalidity fee’. 3. If the purpose of the payment referred to in paragraph 2 cannot immediately be established, the Office shall require the person making the payment to notify it in writing of this purpose within such period as it may specify. If the person does not comply with this request in due time, the payment shall be considered not to have been made. The amount which has been paid shall be refunded. Article 180 Deemed date of payment 1. In the cases referred to in the first subparagraph of Article 179(1), the date on which the payment shall be considered to have been made to the Office shall be the date on which the amount of the payment or of the transfer is actually entered in a bank account held by the Office. 2. Where the methods of payment referred to in the second subparagraph of Article 179(1) may be used, the Executive Director shall establish the date on which such payments are to be considered to have been made. 3. Where, under paragraphs 1 and 2, payment of a fee is not considered to have been made until after the expiry of the period in which it was due, it shall be considered that this period has been observed if evidence is provided to the Office that the persons who made the payment in a Member State, within the period within which the payment should have been made, duly gave an order to a banking establishment to transfer the amount of the payment, and paid a surcharge of 10 % of the relevant fee or fees, but not exceeding EUR 200. No surcharge shall be payable if the relevant order to the banking establishment has been given not later than 10 days before the expiry of the period for payment. 4. The Office may request the person who made the payment to produce evidence as to the date on which the order to the banking establishment as referred to in paragraph 3 was given and, where required, to pay the relevant surcharge within a period to be specified by it. If the person fails to comply with that request or if the evidence is insufficient, or if the required surcharge is not paid in due time, the period for payment shall be considered not to have been observed. Article 181 Insufficient payments and refund of insignificant amounts 1. A time limit for payment shall, in principle, be considered to have been observed only if the full amount of the fee has been paid in due time. If the fee is not paid in full, the amount which has been paid shall be refunded after the period for payment has expired. 2. The Office may, however, in so far as is possible within the time remaining before the end of the period, give the person making the payment the opportunity to pay the amount lacking or, where this is considered justified, overlook any small amounts lacking, without prejudice to the rights of the person making the payment. 3. With the consent of the Budget Committee, the Executive Director may waive action for the enforced recovery of any sum due where the sum to be recovered is minimal or where such recovery is too uncertain. 4. Where an excessive sum is paid to cover a fee or a charge, the excess shall not be refunded if the amount is insignificant and the party concerned has not expressly requested a refund. With the consent of the Budget Committee the Executive Director may determine the amount below which an excessive sum paid to cover a fee or a charge shall not be refunded. Determinations pursuant to the second subparagraph shall be published in the Official Journal of the Office. CHAPTER XIII INTERNATIONAL REGISTRATION OF MARKS SECTION I General provisions Article 182 Application of provisions Unless otherwise specified in this chapter, this Regulation and the acts adopted pursuant to this Regulation shall apply to applications for international registrations under the Madrid Protocol (‘international applications’), based on an application for an EU trade mark or on an EU trade mark and to registrations of marks in the international register maintained by the International Bureau of the World Intellectual Property Organisation (‘international registrations’ and ‘the International Bureau’, respectively) designating the Union. SECTION 2 International registration on the basis of applications for an EU trade mark and of EU trade marks Article 183 Filing of an international application 1. International applications pursuant to Article 3 of the Madrid Protocol based on an application for an EU trade mark or on an EU trade mark shall be filed at the Office. 2. Where an international application is filed before the mark on which the international registration is to be based has been registered as an EU trade mark, the applicant for the international registration shall indicate whether the international registration is to be based on an EU trade mark application or registration. Where the international registration is to be based on an EU trade mark once it is registered, the international application shall be deemed to have been received at the Office on the date of registration of the EU trade mark. Article 184 Form and contents of the international application 1. The international application shall be filed in one of the official languages of the Union, using a form provided by the Office. The Office shall inform the applicant filing the international application of the date on which the documents making up the international application are received by the Office. Unless otherwise specified by the applicant on form when he files the international application, the Office shall correspond with the applicant in the language of filing in a standard form. 2. If the international application is filed in a language which is not one of the languages allowed under the Madrid Protocol, the applicant shall indicate a second language from among those languages. This shall be the language in which the Office submits the international application to the International Bureau. 3. Where the international application is filed in a language other than one of the languages allowed under the Madrid Protocol for the filing of international applications, the applicant may provide a translation of the list of goods or services and of any other textual elements forming part of the international application in the language in which the international application is to be submitted to the International Bureau pursuant to paragraph 2. If the application is not accompanied by such translation, the applicant shall authorise the Office to include that translation in the international application. Where the translation has not yet been established in the course of the registration procedure for the EU trade mark application on which the international application is based, the Office shall, without delay, arrange for the translation. 4. The filing of an international application shall be subject to the payment of a fee to the Office. Where the international registration is to be based on an EU trade mark once it is registered, the fee shall be due on the date of registration of the EU trade mark. The application shall be deemed not to have been filed until the required fee has been paid. Where the fee has not been paid, the Office shall inform the applicant accordingly. In the event of electronic filing, the Office may authorise the International Bureau to collect the fee on its behalf. 5. Where the examination of the international application reveals any of the following deficiencies, the Office shall invite the applicant to remedy those deficiencies within such period as it may specify: (a) the international application has not been filed using the form referred to in paragraph 1, and does not contain all the indications and information required by that form; (b) the list of goods and services contained in the international application is not covered by the list of goods and services appearing in the basic EU trade mark application or basic EU trade mark; (c) the mark which is subject to the international application is not identical with the mark as it appears in the basic EU trade mark application or basic EU trade mark; (d) an indication in the international application as to the trade mark, other than a disclaimer or a colour claim, does not also appear in the basic EU trade mark application or basic EU trade mark; (e) where colour is claimed in the international application as a distinctive feature of the mark, the basic EU trade mark application or basic EU trade mark is not in the same colour or colours; or (f) according to the indications made in the international form, the applicant is not eligible to file an international application through the Office in accordance with Article 2(1)(ii) of the Madrid Protocol. 6. Where the applicant has failed to authorise the Office to include a translation as provided for in paragraph 3, or where it is otherwise unclear on which list of goods and services the international application is to be based, the Office shall invite the applicant to make the required indications within such period as it may specify. 7. If the deficiencies referred to in paragraph 5 are not remedied or the required indications referred to in paragraph 6 are not given within the period fixed by the Office, the Office shall refuse to forward the international application to the International Bureau. 8. The Office shall forward the international application to the International Bureau along with the certification provided for under Article 3(1) of the Madrid Protocol as soon as the international application meets the requirements laid down in this Article, the implementing act adopted pursuant to paragraph 9 of this Article, and in Article 183 of this Regulation. 9. The Commission shall adopt implementing acts specifying the exact form, including the elements thereof, to be used for the filing of an international application pursuant to paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 185 Recordal in the files and in the Register 1. The date and number of an international registration based on an EU trade mark application shall be recorded in the files of that application. When the application results in an EU trade mark, the date and number of the international registration shall be entered in the Register. 2. The date and number of an international registration based on an EU trade mark shall be entered in the Register. Article 186 Notification of the invalidity of the basic application or registration 1. Within a period of five years of the date of the international registration, the Office shall notify the International Bureau of any facts and decisions affecting the validity of the EU trade mark application or the EU trade mark registration on which the international registration was based. 2. The Commission shall adopt implementing acts specifying the individual facts and decisions subject to the notification obligation in accordance with Article 6(3) of the Madrid Protocol as well as the relevant point in time of such notifications. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2) of this Regulation. Article 187 Request for territorial extension subsequent to international registration 1. A request for territorial extension made subsequent to an international registration pursuant to Article 3ter(2) of the Madrid Protocol may be filed through the intermediary of the Office. The request shall be filed in the language in which the international application was filed pursuant to Article 184 of this Regulation. It shall include indications to substantiate the entitlement to make a designation in accordance with Article 2(1)(ii) and Article 3ter(2) of the Madrid Protocol. The Office shall inform the applicant requesting the territorial extension of the date on which the request for territorial extension was received. 2. The Commission shall adopt implementing acts specifying the detailed requirements regarding the request for territorial extension pursuant to paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). 3. Where the request for territorial extension made subsequent to the international registration does not comply with the requirements set out in paragraph 1 and in the implementing act adopted pursuant to paragraph 2, the Office shall invite the applicant to remedy the deficiencies found within such time limit as it may specify. If the deficiencies are not remedied within the time limit fixed by the Office, the Office shall refuse to forward the request to the International Bureau. The Office shall not refuse to forward the request to the International Bureau before the applicant has had the opportunity to correct any deficiency detected in the request. 4. The Office shall forward the request for territorial extension made subsequent to the international registration to the International Bureau as soon as the requirements referred to in paragraph 3 are complied with. Article 188 International fees Any fees payable to the International Bureau under the Madrid Protocol shall be paid direct to the International Bureau. SECTION 3 International registrations designating the Union Article 189 Effects of international registrations designating the Union 1. An international registration designating the Union shall, from the date of its registration pursuant to Article 3(4) of the Madrid Protocol or from the date of the subsequent designation of the Union pursuant to Article 3ter(2) of the Madrid Protocol, have the same effect as an application for an EU trade mark. 2. If no refusal has been notified in accordance with Article 5(1) and (2) of the Madrid Protocol or if any such refusal has been withdrawn, the international registration of a mark designating the Union shall, from the date referred to in paragraph 1, have the same effect as the registration of a mark as an EU trade mark. 3. For the purposes of applying Article 11 of this Regulation, publication of the particulars of the international registration designating the Union pursuant to Article 190(1) shall take the place of publication of an EU trade mark application, and publication pursuant to Article 190(2) shall take the place of publication of the registration of an EU trade mark. Article 190 Publication 1. The Office shall publish the date of registration of a mark designating the Union pursuant to Article 3(4) of the Madrid Protocol or the date of the subsequent designation of the Union pursuant to Article 3ter(2) of the Madrid Protocol, the language of filing of the international application and the second language indicated by the applicant, the number of the international registration and the date of publication of such registration in the Gazette published by the International Bureau, a reproduction of the mark and the numbers of the classes of the goods or services in respect of which protection is claimed. 2. If no refusal of protection of an international registration designating the Union has been notified in accordance with Article 5(1) and (2) of the Madrid Protocol or if any such refusal has been withdrawn, the Office shall publish this fact, together with the number of the international registration and, where applicable, the date of publication of such registration in the Gazette published by the International Bureau. Article 191 Seniority claimed in an international application 1. The applicant for an international registration designating the Union may claim, in the international application, the seniority of an earlier trade mark registered in a Member State, including a trade mark registered in the Benelux countries, or registered under international arrangements having effect in a Member State, as provided for in Article 39. 2. The documentation, as specified in the implementing act adopted pursuant to Article 39(6), in support of the seniority claim shall be submitted within three months of the date on which the International Bureau notifies the international registration to the Office. In this regard, Article 39(7) shall apply. 3. Where the holder of the international registration is obliged to be represented before the Office pursuant to Article 119(2), the communication as referred to in paragraph 2 of this Article shall contain the appointment of a representative within the meaning of Article 120(1). 4. Where the Office finds that the seniority claim under paragraph 1 of this Article does not comply with Article 39, or does not comply with the other requirements laid down in this Article, it shall invite the applicant to remedy the deficiencies. If the requirements referred to in the first sentence are not satisfied within the time limit specified by the Office, the right of seniority in respect of that international registration shall be lost. If the deficiencies concern only some of the goods and services, the right of seniority shall be lost only in so far as those goods and services are concerned. 5. The Office shall inform the International Bureau of any declaration of a loss of the right of seniority pursuant to paragraph 4. It shall also inform the International Bureau of any withdrawal or restriction of the seniority claim. 6. Article 39(5) shall apply, unless the right of seniority is declared lost pursuant to paragraph 4 of this Article. Article 192 Seniority claimed before the Office 1. The holder of an international registration designating the Union may, as from the date of publication of the effects of such registration pursuant to Article 190(2), claim at the Office the seniority of an earlier trade mark registered in a Member State, including a trade mark registered in the Benelux countries, or registered under international arrangements having effect in a Member State, as provided for in Article 40. 2. When the seniority is claimed before the date referred to in paragraph 1, the seniority claim shall be deemed to have been received by the Office on that date. 3. A seniority claim under paragraph 1 of this Article shall fulfil the requirements referred to in Article 40 and shall contain information to enable its examination against those requirements. 4. If the requirements governing the claiming of seniority referred to in paragraph 3 and specified in the implementing act adopted pursuant to paragraph 6 are not fulfilled, the Office shall invite the holder of the international registration to remedy the deficiencies. If the deficiencies are not remedied within a period to be specified by the Office, the Office shall reject the claim. 5. Where the Office has accepted the seniority claim, or where a seniority claim has been withdrawn or cancelled by the Office, the Office shall inform the International Bureau accordingly. 6. The Commission shall adopt implementing acts specifying the details to be contained in a seniority claim under paragraph 1 of this Article and the details of the information to be notified pursuant to paragraph 5 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 193 Designation of goods and services and examination as to absolute grounds for refusal 1. International registrations designating the Union shall be subject to examination as to their conformity with Article 33(2), (3) and (4) and to absolute grounds for refusal in the same way as applications for EU trade marks. 2. Where an international registration designating the Union is found to be ineligible for protection pursuant to Article 33(4) or Article 42(1) of this Regulation for all or any part of the goods and services for which it has been registered by the International Bureau, the Office shall issue an ex officio provisional notification of refusal to the International Bureau, in accordance with Article 5(1) and (2) of the Madrid Protocol. 3. Where the holder of an international registration is obliged to be represented before the Office pursuant to Article 119(2), the notification referred to in paragraph 2 of this Article shall contain an invitation to appoint a representative within the meaning of Article 120(1). 4. The notification of provisional refusal shall state the reasons on which it is based, and shall specify a time period by which the holder of the international registration may submit his observations and, if appropriate, shall appoint a representative. The time period shall start on the day on which the Office issues the provisional refusal. 5. Where the Office finds that the international application designating the Union does not contain the indication of a second language pursuant to Article 206 of this Regulation, the Office shall issue an ex officio provisional notification of refusal to the International Bureau pursuant to Article 5(1) and (2) of the Madrid Protocol. 6. Where the holder of an international registration fails to overcome the ground for refusing protection within the time limit or, if appropriate, to appoint a representative or to indicate a second language, the Office shall refuse the protection in whole or for part of the goods and services for which the international registration is registered. The refusal of protection shall take the place of a refusal of an EU trade mark application. The decision shall be subject to appeal in accordance with Articles 66 to 72. 7. Where, as of the start of the opposition period referred to in Article 196(2), the Office has not issued an ex officio provisional notification of refusal pursuant to paragraph 2 of this Article, it shall send a statement to the International Bureau, indicating that the examination of absolute grounds of refusal pursuant to Article 42 has been completed but that the international registration is still subject to oppositions or observations of third parties. This interim statement shall be without prejudice to the right of the Office to re-open the examination of absolute grounds on its own initiative any time before the final statement of grant of protection has been issued. 8. The Commission shall adopt implementing acts specifying the details to be contained in the notification of ex officio provisional refusal of protection to be sent to the International Bureau and in the final communications to be sent to the International Bureau on the final grant or refusal of protection. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 194 Collective and certification marks 1. Where an international registration is based on a basic application or basic registration relating to a collective mark, certification mark or guarantee mark, the international registration designating the Union shall be dealt with as an EU collective mark or as an EU certification mark, whichever is applicable. 2. The holder of the international registration shall submit the regulations governing the use of the mark, as provided for in Articles 75 and 84, directly to the Office within two months of the date on which the International Bureau notifies the international registration to the Office. 3. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the details of the procedure concerning international registrations based on a basic application or basic registration relating to a collective mark, certification mark or guarantee mark. Article 195 Search 1. Once the Office has received a notification of an international registration designating the Union, it shall draw up a Union search report as provided for in Article 43(1) provided that a request for a search report, pursuant to Article 43(1), is made to the Office within one month of the date of notification. 2. As soon as the Office has received a notification of an international registration designating the Union, the Office shall transmit a copy thereof to the central industrial property office of each Member State which has informed the Office of its decision to operate a search in its own register of trade marks as provided for in Article 43(2) provided that a request for a search report, pursuant to Article 43(2), is made to the Office within one month of the date of notification and the search fee is paid within the same period. 3. Article 43(3) to (6) shall apply mutatis mutandis. 4. The Office shall inform the proprietors of any earlier EU trade marks or EU trade mark applications cited in the Union search report of the publication of the international registration designating the Union as provided for in Article 190(1). This shall apply whether or not the holder of the international registration has requested to receive the EU search report, unless the proprietor of an earlier registration or application requests not to receive the notification. Article 196 Opposition 1. International registration designating the Union shall be subject to opposition in the same way as published EU trade mark applications. 2. Notice of opposition shall be filed within a period of three months which shall begin one month following the date of the publication pursuant to Article 190(1). The opposition shall not be considered as duly entered until the opposition fee has been paid. 3. Refusal of protection shall take the place of refusal of an EU trade mark application. 4. The Commission is empowered to adopt delegated acts in accordance with Article 208 specifying the procedure for the filing and examination of an opposition, including the necessary communications to be made to the International Bureau. Article 197 Replacement of an EU trade mark by an international registration The Office shall, upon request, enter a notice in the Register that an EU trade mark is deemed to have been replaced by an international registration in accordance with Article 4bis of the Madrid Protocol. Article 198 Invalidation of the effects of an international registration 1. The effects of an international registration designating the Union may be declared invalid. 2. The application for invalidation of the effects of an international registration designating the Union shall take the place of an application for a declaration of revocation as provided for in Article 58 or for a declaration of invalidity as provided for in Article 59 or Article 60. 3. Where pursuant to Article 64 or Article 128 of this Regulation and this Article, the effects of an international registration designating the Union have been declared invalid by means of a final decision, the Office shall notify the International Bureau in accordance with Article 5(6) of the Madrid Protocol. 4. The Commission shall adopt implementing acts specifying the details to be contained in the notification to be made to the International Bureau pursuant to paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 199 Legal effect of registration of transfers The recordal of a change in the ownership of an international registration on the International Register shall have the same effect as the entry of a transfer in the Register pursuant to Article 20. Article 200 Legal effect of registration of licences and other rights The recordal of a licence or a restriction of the holder's right of disposal in respect of an international registration in the International Register shall have the same effect as the registration of a right in rem, a levy of execution, insolvency proceedings or a licence in the Register pursuant to Articles 22, 23, 24 and 25 respectively. Article 201 Examination of requests for registration of transfers, licences or restrictions of a holder's right of disposal The Office shall transmit requests to register a change in ownership, a licence or a restriction of the holder's right of disposal, the amendment or cancellation of a licence or the removal of a restriction of the holder's right of disposal which have been filed with it to the International Bureau, if accompanied by appropriate proof of the transfer, licence, or the restriction of the right of disposal, or by proof that the licence no longer exists or that it has been amended, or that the restriction of the right of disposal has been removed. Article 202 Conversion of a designation of the Union through an international registration into a national trade mark application or into a designation of Member States 1. Where a designation of the Union through an international registration has been refused or ceases to have effect, the holder of the international registration may request the conversion of the designation of the Union: (a) into a national trade mark application pursuant to Articles 139, 140 and 141; (b) into a designation of a Member State party to the Madrid Protocol, provided that on the date when conversion was requested it was possible to have designated that Member State directly under the Madrid Protocol. Articles 139, 140 and 141 of this Regulation shall apply. 2. The national trade mark application or the designation of a Member State party to the Madrid Protocol resulting from the conversion of the designation of the Union through an international registration shall enjoy, in respect of the Member State concerned, the date of the international registration pursuant to Article 3(4) of the Madrid Protocol or the date of the extension to the Union pursuant to Article 3ter(2) of the Madrid Protocol, if the latter was made subsequent to the international registration, or the date of priority of that registration and, where appropriate, the seniority of a trade mark of that State claimed under Article 191 of this Regulation. 3. The request for conversion shall be published. 4. The request for conversion of an international registration designating the Union into a national trade mark application shall include the information and indications referred to in Article 140(1). 5. Where conversion is requested pursuant to this Article and Article 139(5) of this Regulation following a failure to renew the international registration, the request referred to in paragraph 4 of this Article shall contain an indication to that effect and the date on which the protection expired. The period of three months provided for in Article 139(5) of this Regulation shall begin to run on the day following the last day on which the renewal may still be effected pursuant to Article 7(4) of the Madrid Protocol. 6. Article 140(3) and (5) shall apply to the request for conversion referred to in paragraph 4 of this Article mutatis mutandis. 7. The request for conversion of an international registration designating the Union into a designation of a Member State party to the Madrid Protocol shall include the indications and elements referred to in paragraphs 4 and 5. 8. Article 140(3) shall apply to the request for conversion referred to in paragraph 7 of this Article mutatis mutandis. The Office shall also reject the request for conversion where the conditions to designate the Member State which is a party to the Madrid Protocol or to the Madrid Agreement were fulfilled neither on the date of the designation of the Union nor on the date on which the application for conversion was received or, pursuant to the last sentence of Article 140(1), is deemed to have been received by the Office. 9. Where the request for conversion referred to in paragraph 7 complies with the requirements of this Regulation and rules adopted pursuant to it, the Office shall transmit the request without delay to the International Bureau. The Office shall inform the holder of the international registration of the date of transmission. 10. The Commission shall adopt implementing acts specifying: (a) the details to be contained in the requests for conversion referred to in paragraphs 4 and 7; (b) the details to be contained in the publication of the requests for conversion pursuant to paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 203 Use of a mark subject of an international registration For the purposes of applying Article 18(1), Article 47(2), Article 58(1)(a) and Article 64(2), the date of publication pursuant to Article 190(2) shall take the place of the date of registration for the purpose of establishing the date as from which the mark which is the subject of an international registration designating the Union shall be put to genuine use in the Union. Article 204 Transformation 1. Subject to paragraph 2, the provisions applicable to EU trade mark applications shall apply mutatis mutandis to applications for transformation of an international registration into an EU trade mark application pursuant to Article 9quinquies of the Madrid Protocol. 2. When the application for transformation relates to an international registration designating the Union the particulars of which have been published pursuant to Article 190(2), Articles 42 to 47 shall not apply. 3. In order to be considered a transformation of an international registration which has been cancelled at the request of the office of origin by the International Bureau pursuant to Article 9quinquies of the Madrid Protocol, an EU trade mark application shall contain an indication to that effect. That indication shall be made when filing the application. 4. Where, in the course of the examination in accordance with Article 41(1)(b), the Office finds that the application was not filed within three months of the date on which the international registration was cancelled by the International Bureau, or the goods and services for which the EU trade mark is to be registered are not contained in the list of goods and services for which the international registration was registered in respect of the Union, the Office shall invite the applicant to remedy the deficiencies. 5. If the deficiencies referred to in paragraph 4 are not remedied within the time period specified by the Office, the right to the date of the international registration or the territorial extension and, if any, of the priority of the international registration shall be lost. 6. The Commission shall adopt implementing acts specifying the details to be contained in an application for transformation pursuant to paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 207(2). Article 205 Communication with the International Bureau Communication with the International Bureau shall be in a manner and format agreed on between the International Bureau and the Office, and preferably be by electronic means. Any reference to forms shall be construed as including forms made available in electronic format. Article 206 Use of languages For the purpose of applying this Regulation, and rules adopted pursuant to it, to international registrations designating the Union, the language of filing of the international application shall be the language of the proceedings within the meaning of Article 146(4), and the second language indicated in the international application shall be the second language within the meaning of Article 146(3). CHAPTER XIV FINAL PROVISIONS Article 207 Committee Procedure 1. The Commission shall be assisted by a Committee on Implementation Rules. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 208 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 48, Article 49(3), Articles 65 and 73, Articles 96(4), 97(6), 98(5), 100(2), 101(5), 103(3), and 106(3), Articles 121 and 168, and Articles 194(3) and 196(4) shall be conferred on the Commission for an indeterminate period of time from 23 March 2016. 3. The delegation of power referred to in Article 48, Article 49(3), Articles 65 and 73, Articles 96(4), 97(6), 98(5), 100(2), 101(5), 103(3), and 106(3), Articles 121 and 168, and Articles 194(3) and 196(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall carry out consultations with experts, including experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 48, Article 49(3), Articles 65 and 73, Articles 96(4), 97(6), 98(5), 100(2), 101(5), 103(3), and 106(3), Articles 121 and 168, and Articles 194(3) and 196(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 209 Provisions relating to the enlargement of the Union 1. As of the date of accession of Bulgaria, the Czech Republic, Estonia, Croatia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Romania, Slovenia and Slovakia (‘new Member State(s)’), an EU trade mark registered or applied for pursuant to this Regulation before their respective date of accession shall be extended to the territory of those Member States in order to have equal effect throughout the Union. 2. The registration of an EU trade mark which was under application at the date of accession may not be refused on the basis of any of the absolute grounds for refusal listed in Article 7(1), if these grounds became applicable merely because of the accession of a new Member State. 3. Where an application for the registration of an EU trade mark has been filed during the six months prior to the date of accession, notice of opposition may be given pursuant to Article 46 where an earlier trade mark or another earlier right within the meaning of Article 8 was acquired in a new Member State prior to accession, provided that it was acquired in good faith and that the filing date or, where applicable, the priority date or the date of acquisition in the new Member State of the earlier trade mark or other earlier right precedes the filing date or, where applicable, the priority date of the EU trade mark applied for. 4. An EU trade mark as referred to in paragraph 1 may not be declared invalid: (a) pursuant to Article 59 if the grounds for invalidity became applicable merely because of the accession of a new Member State; (b) pursuant to Article 60(1) and (2) if the earlier national right was registered, applied for or acquired in a new Member State prior to the date of accession. 5. The use of an EU trade mark as referred to in paragraph 1 may be prohibited pursuant to Articles 137 and 138, if the earlier trade mark or other earlier right was registered, applied for or acquired in good faith in the new Member State prior to the date of accession of that State; or, where applicable, has a priority date prior to the date of accession of that State. Article 210 Evaluation and review 1. By 24 March 2021, and every five years thereafter, the Commission shall evaluate the implementation of this Regulation. 2. The evaluation shall review the legal framework for cooperation between the Office and the central industrial property offices of the Member States and the Benelux Office for Intellectual Property, paying particular attention to the financing mechanism laid down in Article 152. The evaluation shall further assess the impact, effectiveness and efficiency of the Office and its working practices. The evaluation shall, in particular, address the possible need to modify the mandate of the Office, and the financial implications of any such modification. 3. The Commission shall forward the evaluation report together with its conclusions drawn on the basis of that report to the European Parliament, the Council and the Management Board. The findings of the evaluation shall be made public. 4. On the occasion of every second evaluation, there shall be an assessment of the results achieved by the Office having regard to its objectives, mandate and tasks. Article 211 Repeal Regulation (EC) No 207/2009 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex III. Article 212 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 October 2017. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 14 June 2017. For the European Parliament The President A. TAJANI For the Council The President H. DALLI (1) Position of the European Parliament of 27 April 2017 (not yet published in the Official Journal) and decision of the Council of 22 May 2017. (2) Council Regulation (EC) No 207/2009 of 26 February 2009 on the European Union trade mark (OJ L 78, 24.3.2009, p. 1). (3) See Annex II. (4) Council Regulation (EC) No 40/94 of 20 December 1993 on the Community trade mark (OJ L 11, 14.1.1994, p. 1). (5) First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks (OJ L 40, 11.2.1989, p. 1). (6) Directive 2008/95/EC of the European Parliament and of the Council of 22 October 2008 to approximate the laws of the Member States relating to trade marks (OJ L 299, 8.11.2008, p. 25). (7) Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising (OJ L 376, 27.12.2006, p. 21). (8) Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15). (9) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). (10) OJ L 123, 12.5.2016, p. 1. (11) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (12) Directive (EU) 2015/2436 of the European Parliament and of the Council of 16 December 2015 to approximate the laws of the Member States relating to trade marks (OJ L 336, 23.12.2015, p. 1). (13) Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1). (14) Directive 2001/24/EC of the European Parliament and of the Council of 4 April 2001 on the reorganisation and winding up of credit institutions (OJ L 125, 5.5.2001, p. 15). (15) OJ L 56, 4.3.1968, p. 1. (16) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (17) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (18) Commission Decision (EU, Euratom) 2015/443 of 13 March 2015 on Security in the Commission (OJ L 72, 17.3.2015, p. 41). (19) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). (20) Council Regulation (EC) No 6/2002 of 12 December 2001 on Community designs (OJ L 3, 5.1.2002, p. 1). (21) Regulation (EU) No 386/2012 of the European Parliament and of the Council of 19 April 2012 on entrusting the Office for Harmonization in the Internal Market (Trade Marks and Designs) with tasks related to the enforcement of intellectual property rights, including the assembling of public and private-sector representatives as a European Observatory on Infringements of Intellectual Property Rights (OJ L 129, 16.5.2012, p. 1). (22) Directive 2012/28/EU of the European Parliament and of the Council of 25 October 2012 on certain permitted uses of orphan works (OJ L 299, 27.10.2012, p. 5). (23) Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). (24) Commission Delegated Regulation (EU) No 1268/2012 of 29 October 2012 on the rules of application of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council on the financial rules applicable to the general budget of the Union (OJ L 362, 31.12.2012, p. 1). (25) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (26) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). ANNEX I AMOUNT OF FEES A. The fees to be paid to the Office under this Regulation shall be as follows (in EUR): 1. Basic fee for the application for an individual EU trade mark (Article 31(2)): EUR 1 000 2. Basic fee for the application for an individual EU trade mark by electronic means (Article 31(2)): EUR 850 3. Fee for the second class of goods and services for an individual EU trade mark (Article 31(2)): EUR 50 4. Fee for each class of goods and services exceeding two for an individual EU trade mark (Article 31(2)): EUR 150 5. Basic fee for the application for an EU collective mark or an EU certification mark (Article 31(2) and Article 74(3) or Article 83(3)): EUR 1 800 6. Basic fee for the application for an EU collective mark or an EU certification mark by electronic means (Article 31(2) and Article 74(3) or Article 83(3)): EUR 1 500 7. Fee for the second class of goods and services for an EU collective mark or an EU certification mark: (Article 31(2) and Article 74(3) or Article 83(3)): EUR 50 8. Fee for each class of goods and services exceeding two for an EU collective mark or an EU certification mark (Article 31(2) and 74(3) or Article 83(3)): EUR 150 9. Search fee for an EU trade mark application (Article 43(2)) or for an international registration designating the Union (Article 43(2) and Article 195(2)): EUR 12 multiplied by the number of central industrial property offices referred to in Article 43(2); that amount, and the subsequent changes, shall be published by the Office in the Official Journal of the Office. 10. Opposition fee (Article 46(3)): EUR 320 11. Basic fee for the renewal of an individual EU trade mark (Article 53(3)): EUR 1 000 12. Basic fee for the renewal of an individual EU trade mark by electronic means (Article 53(3)): EUR 850 13. Fee for the renewal of the second class of goods and services for an individual EU trade mark (Article 53(3)): EUR 50 14. Fee for the renewal of each class of goods and services exceeding two for an individual EU trade mark (Article 53(3)): EUR 150 15. Basic fee for the renewal of an EU collective mark or an EU certification mark (Article 53(3) and Article 74(3) or Article 83(3): EUR 1 800 16. Basic fee for the renewal of an EU collective mark or an EU certification mark by electronic means (Article 53(3) and Article 74(3) or Article 83(3)): EUR 1 500 17. Fee for the renewal of the second class of goods and services for an EU collective mark or an EU certification mark (Article 53(3) and Article 74(3) or Article 83(3)): EUR 50 18. Fee for the renewal of each class of goods and services exceeding two for an EU collective mark or an EU certification mark (Article 53(3) and Article 74(3) or Article 83(3)): EUR 150 19. Additional fee for the late payment of the renewal fee or the late submission of the request for renewal (Article 53(3)): 25 % of the belated renewal fee, subject to a maximum of EUR 1 500 20. Fee for the application for revocation or for a declaration of invalidity (Article 63(2)): EUR 630 21. Appeal fee (Article 68(1)): EUR 720 22. Fee for the application of restitutio in integrum (Article 104(3)): EUR 200 23. Fee for the application for the conversion of an EU trade mark application or an EU trade mark (Article 140(1), also in conjunction with Article 202(1)): (a) into a national trade mark application; (b) into a designation of Member States under the Madrid Protocol: EUR 200 24. Fee for continuation of proceedings (Article 105(1)): EUR 400 25. Fee for the declaration of division of a registered EU trade mark (Article 56(4) or an application for an EU trade mark (Article 50(3)): EUR 250 26. Fee for the application for the registration of a licence or another right in respect of a registered EU trade mark (Article 26(2)) or an application for an EU trade mark (Article 26(2)): (a) grant of a licence; (b) transfer of a licence; (c) creation of a right in rem; (d) transfer of a right in rem; (e) levy of execution: EUR 200 per registration, but where multiple requests are submitted in the same application or at the same time, not to exceed a total of EUR 1 000 27. Fee for the cancellation of the registration of a licence or other right (Article 29(3)): EUR 200 per cancellation, but where multiple requests are submitted in the same application or at the same time, not to exceed a total of EUR 1 000 28. Fee for the alteration of a registered EU trade mark (Article 54(4)): EUR 200 29. Fee for the issue of a copy of the application for an EU trade mark (Article 114(7)), a copy of the certificate of registration (Article 51(2)), or an extract from the register (Article 111(7)): (a) uncertified copy or extract: EUR 10 (b) certified copy or extract: EUR 30 30. Fee for the inspection of the files (Article 114(6)): EUR 30 31. Fee for the issue of copies of file documents (Article 114(7)): (a) uncertified copy: EUR 10 (b) certified copy: EUR 30 plus per page, exceeding 10 EUR 1 32. Fee for the communication of information in a file (Article 114(9)): EUR 10 33. Fee for the review of the determination of the procedural costs to be refunded (Article 109(8)): EUR 100 34. Fee for the filing of an international application at the Office (Article 184(4)): EUR 300 B. Fees to be paid to the International Bureau I. Individual fee for an international registration designating the Union 1. The applicant for an international registration designating the Union shall be required to pay to the International Bureau an individual fee for the designation of the Union in accordance with Article 8(7) of the Madrid Protocol. 2. The holder of an international registration who files a request for territorial extension designating the Union made subsequent to the international registration shall be required to pay to the International Bureau an individual fee for the designation of the Union in accordance with Article 8(7) of the Madrid Protocol. 3. The amount of the fee under points B.I.1 or B.I.2 shall be the equivalent in Swiss Francs, as established by the Director-General of the WIPO pursuant to Rule 35(2) of the Common Regulations under the Madrid Agreement and Protocol, of the following amounts: (a) for an individual trade mark: EUR 820 plus, where applicable, EUR 50 for the second class of goods and services and EUR 150 for each class of goods and services contained in the international registration exceeding two; (b) for a collective mark or a certification mark: EUR 1 400 plus, where applicable, EUR 50 for the second class of goods and services and EUR 150 for each class of goods or services exceeding two. II. Individual fee for a renewal of an international registration designating the Union 1. The holder of an international registration designating the Union shall be required to pay to the International Bureau, as a part of the fees for a renewal of the international registration, an individual fee for the designation of the Union in accordance with Article 8(7) of the Madrid Protocol. 2. The amount of the fee referred to in point B.II.1 shall be the equivalent in Swiss Francs, as established by the Director-General of the WIPO pursuant to Rule 35(2) of the Common Regulations under the Madrid Agreement and Protocol, of the following amounts: (a) for an individual trade mark: EUR 820 plus, where applicable, EUR 50 for the second class of goods and services and EUR 150 for each class of goods and services contained in the international registration exceeding two; (b) for a collective mark or a certification mark: EUR 1 400 plus, where applicable, EUR 50 for the second class of goods and services and EUR 150 for each class of goods and services contained in the international registration exceeding two. ANNEX II Repealed Regulation with list of its successive amendments Council Regulation (EC) No 207/2009 (OJ L 78, 24.3.2009, p. 1) Act of Accession of 2012, Annex III, point 2(I) Regulation (EU) 2015/2424 of the European Parliament and of the Council (OJ L 341, 24.12.2015, p. 21) Only Article 1 ANNEX III Correlation table Regulation (EC) No 207/2009 This Regulation Articles 1 to 7 Articles 1 to 7 Article 8(1) to (4) Article 8(1) to (4) Article 8(4a) Article 8(6) Article 8(5) Article 8(5) Article 9 Article 9 Article 9a Article 10 Article 9b Article 11 Article 10 Article 12 Article 11 Article 13 Article 12 Article 14 Article 13 Article 15 Article 13a Article 16 Article 14 Article 17 Article 15 Article 18 Article 16 Article 19 Article 17(1), (2) and (3) Article 20(1), (2) and (3) Article 17(5) Article 20(4) Article 17(5a) Article 20(5) Article 17(5b) Article 20(6) Article 17(5c) Article 20(7) Article 17(5d) Article 20(8) Article 17(5e) Article 20(9) Article 17(5f) Article 20(10) Article 17(6) Article 20(11) Article 17(7) Article 20(12) Article 17(8) Article 20(13) Article 18 Article 21 Article 19 Article 22 Article 20 Article 23 Article 21 Article 24 Article 22 Article 25 Article 22a Article 26 Article 23 Article 27 Article 24 Article 28 Article 24a Article 29 Article 25 Article 30 Article 26 Article 31 Article 27 Article 32 Article 28 Article 33 Article 29 Article 34 Article 30 Article 35 Article 31 Article 36 Article 32 Article 37 Article 33 Article 38 Article 34(1) Article 39(1) Article 34(1a) Article 39(2) Article 34(2) Article 39(3) Article 34(3) Article 39(4) Article 34(4) Article 39(5) Article 34(5) Article 39(6) Article 34(6) Article 39(7) Article 35 Article 40 Article 36 Article 41 Article 37(1) Article 42(1) Article 37(3) Article 42(2) Article 38 Article 43 Article 39 Article 44 Article 40 Article 45 Article 41 Article 46 Article 42 Article 47 Article 42a Article 48 Article 43 Article 49 Article 44(1) and (2) Article 50(1) and (2) Article 44(4) Article 50(3) Article 44(4a) Article 50(4) Article 44(5) to (9) Article 50(5) to (9) Article 45 Article 51 Article 46 Article 52 Article 47 Article 53 Article 48 Article 54 Article 48a Article 55 Article 49 Article 56 Article 50 Article 57 Article 51 Article 58 Article 52 Article 59 Article 53 Article 60 Article 54 Article 61 Article 55 Article 62 Article 56 Article 63 Article 57 Article 64 Article 57a Article 65 Article 58 Article 66 Article 59 Article 67 Article 60 Article 68 Article 61 Article 69 Article 63 Article 70 Article 64 Article 71 Article 65 Article 72 Article 65a Article 73 Article 66 Article 74 Article 67 Article 75 Article 68 Article 76 Article 69 Article 77 Article 70 Article 78 Article 71 Article 79 Article 72 Article 80 Article 73 Article 81 Article 74 Article 82 Article 74a Article 83 Article 74b Article 84 Article 74c Article 85 Article 74d Article 86 Article 74e Article 87 Article 74f Article 88 Article 74g Article 89 Article 74h Article 90 Article 74i Article 91 Article 74j Article 92 Article 74k Article 93 Article 75 Article 94 Article 76 Article 95 Article 77 Article 96 Article 78 Article 97 Article 79 Article 98 Article 79a Article 99 Article 79b Article 100 Article 79c Article 101 Article 79d Article 102 Article 80 Article 103 Article 81 Article 104 Article 82 Article 105 Article 82a Article 106 Article 83 Article 107 Article 84 Article 108 Article 85(1) Article 109(1) Article 85(1a) Article 109(2) Article 85(2) Article 109(3) Article 85(3) Article 109(4) Article 85(4) Article 109(5) Article 85(5) Article 109(6) Article 85(6) Article 109(7) Article 85(7) Article 109(8) Article 86 Article 110 Article 87 Article 111 Article 87a Article 112 Article 87b Article 113 Article 88 Article 114 Article 88a Article 115 Article 89 Article 116 Article 90 Article 117 Article 91 Article 118 Article 92 Article 119 Article 93 Article 120 Article 93a Article 121 Article 94 Article 122 Article 95(1) Article 123(1) Article 95(2) — Article 95(3) Article 123(2) Article 95(4) Article 123(3) Article 95(5) — Article 96 Article 124 Article 97 Article 125 Article 98 Article 126 Article 99 Article 127 Article 100 Article 128 Article 101 Article 129 Article 102 Article 130 Article 103 Article 131 Article 104 Article 132 Article 105 Article 133 Article 106 Article 134 Article 107 Article 135 Article 109 Article 136 Article 110 Article 137 Article 111 Article 138 Article 112 Article 139 Article 113 Article 140 Article 114 Article 141 Article 115 Article 142 Article 116 Article 143 Article 117 Article 144 Article 118 Article 145 Article 119(1) to (5) Article 146(1) to (5) Article 119(5a) Article 146(6) Article 119(6) Article 146(7) Article 119(7) Article 146(8) Article 119(8) Article 146(9) Article 119(9) Article 146(10) Article 119(10) Article 146(11) Article 120 Article 147 Article 121 Article 148 Article 123 Article 149 Article 123a Article 150 Article 123b Article 151 Article 123c Article 152 Article 124 Article 153 Article 125 Article 154 Article 126 Article 155 Article 127 Article 156 Article 128 Article 157 Article 129 Article 158 Article 130 Article 159 Article 131 Article 160 Article 132 Article 161 Article 133 Article 162 Article 134 Article 163 Article 134a Article 164 Article 135 Article 165 Article 136 Article 166 Article 136a Article 167 Article 136b Article 168 Article 137 Article 169 Article 137a Article 170 Article 138 Article 171 Article 139 Article 172 Article 140 Article 173 Article 141 Article 174 Article 141a Article 175 Article 142 Article 176 Article 143 Article 177 Article 144 Article 178 Article 144a Article 179 Article 144b Article 180 Article 144c Article 181 Article 145 Article 182 Article 146 Article 183 Article 147 Article 184 Article 148 Article 185 Article 148a Article 186 Article 149 Article 187 Article 150 Article 188 Article 151 Article 189 Article 152 Article 190 Article 153 Article 191 Article 153a Article 192 Article 154 Article 193 Article 154a Article 194 Article 155 Article 195 Article 156 Article 196 Article 157 Article 197 Article 158 Article 198 Article 158a Article 199 Article 158b Article 200 Article 158c Article 201 Article 159 Article 202 Article 160 Article 203 Article 161 Article 204 Article 161a Article 205 Article 161b Article 206 Article 163 Article 207 Article 163a(1) Article 208(1) Article 163a(2), first sentence Article 208(2) Article 163a(2), second sentence Article 208(4) Article 163a(3) Article 208(3) Article 163a(4) Article 208(5) Article 163a(5) Article 208(6) Article 165 Article 209 Article 165a Article 210 Article 166 Article 211 Article 167 Article 212 Annex -I Annex I Annex I Annex II Annex II Annex III

European Union trade mark European Union trade mark SUMMARY OF: Regulation (EU) 2017/1001 on the European Union trade mark WHAT IS THE AIM OF THE REGULATION? It establishes EU-wide rules and conditions for the granting of an EU trade mark. It codifies and replaces Council Regulation (EC) No 207/2009 and its numerous successive amendments. KEY POINTS EU trade mark Any person or company, including authorities established under public law, may obtain an EU trade mark through registration. It may consist of any signs, in particular words (including personal names), designs, letters, numerals and the shape of goods or of their packaging, provided that such signs are capable of: distinguishing the goods or services of one business from those of another; and being represented on the register of trade marks in such a way that the public and the authorities know exactly the subject matter that is being protected. Owner’s rights It grants the owner exclusive rights, which prohibit third parties from using any of the following for commercial purposes: any sign which is identical with the EU trade mark in relation to goods or services which are identical with those for which the EU trade mark is registered; any sign where there is a likelihood of confusion with another trade mark; any sign which is identical with, or similar to, the EU trade mark in relation to goods or services which are not similar to those for which the EU trade mark is registered, where use of that sign takes advantage of the reputation and distinctive character of the trade mark. However, the owner of the EU trade mark may not prohibit third parties from using the following for commercial purposes: the owner’s own name or address; indications concerning characteristics of goods or services such as the kind, quality or quantity; the trade mark where it is necessary to indicate the intended purpose of a product or service, as accessories or spare parts. Application Applicants must file an application for an EU trade mark with the European Union Intellectual Property Office (EUIPO). The application must contain the following information: a request for the registration of a EU trade mark, information identifying the applicant, a list of the goods or services in respect of which the registration is requested, a representation of the trade mark. Applicants must also pay an application fee. The application fee must be paid within 1 month of the filing date — the date on which the documents are filed with the EUIPO. Registration Once the application has been filed, EUIPO will examine whether it meets all the conditions for the granting of an EU trade mark. Publication of the application will allow third parties opposed to the granting of the trade mark to do so, on the basis of earlier rights, in opposition proceedings. If the application meets all the required criteria and no opposition is either entered or accepted, then the trade mark registration is published. Duration and renewal EU trade marks are registered for a period of 10 years from the date of filing of the application. Registration may be renewed for further periods of 10 years. The renewal application must be filed 6 months before the end of the validity of the registration. Surrender, revocation and invalidity An EU trade mark may be surrendered in respect of some or all of the goods or services for which it is registered. The rights of the owner may also be revoked if: the trade mark has not been subject to genuine use* in the EU for 5 years; the trade mark has become the common name for a product or service; the trade mark could deceive the public as to the nature, quality or geographical origin of the goods or services. The regulation also establishes grounds for invalidity of the trade mark. These grounds include, for example, cases where the applicant acted in bad faith when filing the application for the trade mark. EU collective marksWhen an application for registration is filed, it is possible to designate an EU trade mark as being collective. The following are authorised to file EU collective marks — associations of: manufacturers producers suppliers of services traders legal persons governed by public law. EU certification marksIt is also possible to designate an EU trade mark as a certification mark. The owner of such a mark certifies the material, mode of manufacture of goods or performance of services, quality, accuracy or other characteristics (excluding geographical origin) of the certified goods and services. Legal action Regulation (EU) No 1215/2012 applies to proceedings relating to EU trade marks and applications for EU trade marks, as well as to simultaneous and successive actions on the basis of EU and national trade marks.EU countries must designate ‘EU trade mark courts’. These courts have exclusive jurisdiction in all disputes concerning the infringement and validity of EU trade marks. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 October 2017. BACKGROUND EUIPO replaces the Office for Harmonization in the Internal Market from 23 March 2016 in line with Regulation (EU) 2015/2424 which amended Regulation (EC) No 207/2009 both of which were replaced by Regulation (EU) 2017/1001 . For more information, see: EUIPO — trade marks. KEY TERMS Genuine use: if a company registers an EU trade mark, uses it for a period and then stops using it for a continuous period of 5 years, the trade mark may be revoked. This is because there is no value in giving protection to trade marks if they are not being used and there is no interest in preventing another company, that might legitimately wish to use the mark, from using it. MAIN DOCUMENT Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ L 154, 16.6.2017, pp. 1-99) last update 13.02.2018

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28.10.2017 EN Official Journal of the European Union L 280/1 REGULATION (EU) 2017/1938 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2017 concerning measures to safeguard the security of gas supply and repealing Regulation (EU) No 994/2010 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 194(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) Natural gas (gas) remains an essential component of the energy supply of the Union. A large proportion of such gas is imported into the Union from third countries. (2) A major disruption of gas supply can affect all Member States, the Union and Contracting Parties to the Treaty establishing the Energy Community, signed in Athens on 25 October 2005. It can also severely damage the Union economy and can have a major social impact, in particular on vulnerable groups of customers. (3) This Regulation aims to ensure that all the necessary measures are taken to safeguard an uninterrupted supply of gas throughout the Union, in particular to protected customers in the event of difficult climatic conditions or disruptions of the gas supply. Those objectives should be achieved through the most cost-effective measures and in such a way that gas markets are not distorted. (4) Union law, in particular Directive 2009/72/EC of the European Parliament and of the Council (3), Directive 2009/73/EC of the European Parliament and of the Council (4), Regulation (EC) No 713/2009 of the European Parliament and of the Council (5), Regulation (EC) No 714/2009 of the European Parliament and of the Council (6), Regulation (EC) No 715/2009 of the European Parliament and of the Council (7) and Regulation (EU)No 994/2010 of the European Parliament and of the Council (8), has already had a significant positive impact on the security of gas supply in the Union, both in terms of preparation and mitigation. Member States are better prepared to face a supply crisis now that they are required to establish preventive action plans and emergency plans, and they are better protected now that they have to meet a number of obligations regarding infrastructure capacity and gas supply. However, the Commission's report on the implementation of Regulation (EU) No 994/2010 of October 2014 highlighted areas in which improvements to that Regulation could further bolster the security of gas supply in the Union. (5) The Commission's communication of 16 October 2014 on the short-term resilience of the European gas system analysed the effects of a partial or complete disruption of gas supplies from Russia and concluded that purely national approaches are not very effective in the event of severe disruption, given their scope, which is by definition limited. The stress test showed how a more cooperative approach among Member States could significantly reduce the impact of very severe disruption scenarios in the most vulnerable Member States. (6) Energy security constitutes one of the objectives of the Energy Union Strategy, as set out in the Commission's communication of 25 February 2015 on a Framework Strategy for a Resilient Energy Union with a Forward-Looking Climate Change Policy, which also emphasised the ‘energy efficiency first’ principle and the need to fully implement existing Union energy legal acts. The communication highlighted the fact that the Energy Union rests on solidarity, enshrined in Article 194 of the Treaty on the Functioning of the European Union (TFEU), and trust, which are necessary features of energy security. This Regulation is intended to boost solidarity and trust between the Member States and put in place the measures needed to achieve those aims. When assessing the preventive action plans and the emergency plans established by the Member States, the Commission should also be able to draw the attention of the Member States to the objectives of the Energy Union. (7) An internal gas market that operates smoothly is the best guarantee of the security of gas supply across the Union and to reduce the exposure of individual Member States to the harmful effects of disruptions of gas supply. Where a Member State's security of gas supply is threatened, there is a risk that measures developed unilaterally by that Member State may jeopardise the proper functioning of the internal gas market and damage the gas supply to customers in other Member States. To allow the internal gas market to function even in the face of a shortage of supply, provision must be made for solidarity and coordination in the response to supply crises, as regards both preventive action and the reaction to actual disruptions of gas supply. (8) A truly interconnected internal energy market with multiple entry points and reverse flows can be created only by fully interconnecting its gas grids, by building up liquefied natural gas (LNG) hubs in the Union's Southern and Eastern regions, by completing the North-South and Southern Gas corridors and by further developing domestic production. Therefore, an accelerated development of interconnections and projects aiming to diversify supply sources, as already shortlisted in the Energy Security Strategy, is necessary. (9) So far, the potential for more efficient and less costly measures through regional cooperation has not been fully exploited. This has to do not only with better coordination of national mitigation actions in emergency situations, but also with national preventive measures, such as national storage or policies related to LNG, which can be strategically important in certain regions of the Union. (10) In a spirit of solidarity, regional cooperation, involving both public authorities and natural gas undertakings, should be the guiding principle of this Regulation, to mitigate the identified risks and optimise the benefits of coordinated measures and to implement the most cost-effective measures for Union consumers. Regional cooperation should gradually be complemented with a stronger Union perspective, allowing recourse to all available supplies and tools in the entire internal gas market. Union-level assessment of the emergency supply corridors should be incorporated into the regional cooperation. (11) A risk-based approach to assessing the security of supply and establishing preventive and mitigating measures enables efforts to be coordinated and brings significant benefits in terms of the effectiveness of measures and optimisation of resources. This applies particularly to measures designed to guarantee a continued supply, under very demanding conditions, to protected customers, and to measures to mitigate the impact of an emergency. Assessing correlated risks jointly in risk groups which is both more comprehensive and more precise, will ensure that Member States are better prepared for any crises. Moreover, in an emergency, a coordinated and pre-agreed approach to the security of supply ensures a consistent response and reduces the risk of negative spill-over effects that purely national measures could have in neighbouring Member States. (12) For the purpose of the risk-based approach, risk groups should be defined based on the major transnational risks to the security of gas supply in the Union. Such risks were identified in the Commission's communication of 16 October 2014 on the short-term resilience of the European gas system and the assessment included in the latest Ten-Year Network Development Plan (TYNDP) developed by the European Network of Transmission System Operators for Gas (ENTSOG). To allow for a more precise and better focused assessment for the purposes of this Regulation, the risk groups should be composed on the basis of the main gas supply sources and routes. (13) To provide input to the common and national risk assessments, ENTSOG, in consultation with the Gas Coordination Group (GCG) and with the European Network of Transmission System Operators for Electricity (ENTSO-E), should carry out a Union-wide simulation of gas supply and infrastructure disruption scenarios. Such a simulation should be repeated at least every two years. As a means of strengthening regional cooperation by providing information about gas flows as well as providing technical and operational expertise, the Regional Coordination System for Gas (ReCo System for Gas), established by ENTSOG and composed of standing expert groups, should be involved in carrying out simulations. ENTSOG should ensure an appropriate level of transparency and access to the modelling assumptions used in its scenarios. (14) The Commission should be empowered to update the composition of the risk groups by means of a delegated act based on the evolution of the major transnational risks to the security of gas supply in the Union and its impact on Member States, taking into account the result of the Union-wide simulation and the discussion within the GCG. (15) In order to make the regional cooperation feasible, Member States should agree on a cooperation mechanism within each risk group. Such a mechanism should be developed sufficiently in time to allow for conducting the common risk assessment and discussing and agreeing on appropriate and effective cross-border measures, which will require the agreement of each Member State concerned, to be included in the regional chapters of the preventive action plans and the emergency plans, after consulting the Commission. Member States are free to agree on a cooperation mechanism best suited to a given risk group. The Commission should be able to have a facilitating role in the overall process and share best practices for arranging regional cooperation such as a rotating coordination role within the risk groups for the preparation of the different documents or establishing dedicated bodies. In the absence of an agreement on the cooperation mechanism, the Commission should propose a suitable cooperation mechanism for a given risk group. (16) When conducting the common risk assessment, competent authorities should assess all relevant risk factors which could lead to the materialisation of the major transnational risk for which the risk group was created, including disruption of gas supply from the single largest supplier. Those risk factors should be addressed by appropriate cross-border measures agreed by the competent authorities of the Member States concerned. The cross-border measures should be included in the regional chapters of the preventive action plans and the emergency plans. In addition, the competent authorities should conduct a comprehensive national risk assessment and assess natural, technological, commercial, financial, social, political and market-related risks, andany other relevant ones. All risks should be addressed by effective, proportionate and non-discriminatory measures to be developed in the preventive action plans and the emergency plans. The results of the common and national risk assessments should also contribute to the all hazard risk assessments provided for in Article 6 of Decision No 1313/2013/EU of the European Parliament and of the Council (9) and should be fully taken into account in the national risk assessments. (17) To ensure maximum preparedness, so as to avoid a disruption of gas supply and mitigate its effects should it nevertheless occur, the competent authorities of a given risk group should, after consulting stakeholders, establish preventive action plans and emergency plans that will contain regional chapters. They should be designed so as to address national risks in a way that takes full advantage of the opportunities provided by regional cooperation.The plans should be technical and operational in nature, their function being to help prevent the occurrence or escalation of an emergency or to mitigate its effects. The plans should take the security of electricity systems into account and should be consistent with the Energy Union's strategic planning and reporting tools. (18) When establishing and implementing the preventive action plans and the emergency plans, the competent authorities should, at all times, take account of the safe operation of the gas system at regional and national levels. They should address and set out in those plans the technical constraints affecting the operation of the network, including any technical and safety reasons for reducing flows in the event of an emergency. (19) The Commission should assess the preventive action plans and the emergency plans duly taking into account the views expressed in the GCG and recommend their review, in particular if the plans do not effectively address the risks identified in the risk assessment, if they distort competition or hamper the functioning of the internal energy market, if they endanger the security of gas supply of other Member States or if they do not comply with the provisions of this Regulation or other Union law. The competent authority of the Member State should take account of the Commission's recommendations. Where, following the final position of the competent authority, the Commission concludes that the measure in question would endanger the security of gas supply of another Member State or the Union, the Commission should continue the dialogue with the Member State concerned for it to agree to amend or withdraw the measure. (20) The preventive action plans and the emergency plans should be updated regularly and published. To ensure that the emergency plans are always up-to-date and effective, Member States should carry out at least one test between the updates of the plans by simulating high and medium-impact scenarios and responses in real time. The competent authorities should present the test results at the GCG. (21) Mandatory comprehensive templates including all the risks to be covered by the risk assessment and all the components of the preventive action plans and the emergency plans are needed to facilitate the risk assessment and preparation of the plans and their assessment by the Commission. (22) To facilitate communication between Member States and the Commission, the risk assessments, the preventive action plans, the emergency plans and all other documents and information exchanges provided for in this Regulation should be notified using a secure and standardised electronic notification system. (23) Certain customers, including households and customers providing essential social services are particularly vulnerable and may need protection against the negative effects of disruption of gas supply. A definition of such protected customers should not conflict with the Union solidarity mechanisms. (24) It is appropriate to narrow down the definition of customers protected under the solidarity mechanism. This is required by the obligation of Member States to provide solidarity in the case of extreme circumstances and for essential needs. The definition of solidarity protected customers should therefore be limited to households while still being able to include, under specific conditions, certain essential social services and district heating installations. It is therefore possible for Member States to treat, in accordance with that framework, healthcare, essential social care, emergency and security services as solidarity protected customers, including where those services are performed by a public administration. (25) Responsibility for the security of gas supply should be shared by natural gas undertakings, Member States, acting through their competent authorities, and the Commission, within their respective remits. Such shared responsibility requires very close cooperation between those parties. However, customers using gas for electricity generation or industrial purposes may also have an important role to play in the security of gas supply, as they can respond to a crisis by taking demand-side measures, such as interruptible contracts and fuel switching, which have an immediate impact on the balance of demand and supply. Moreover, the security of gas supply to certain customers using gas for electricity generation may also be considered to be essential in some cases. In an emergency, it should be possible for a Member State to prioritise gas supply to such customers under certain conditions even over the gas supply to protected customers. In exceptional circumstances gas supply to some of such customers prioritised in an emergency over protected customers may also continue in a Member State providing solidarity to avoid severe damage to the functioning of the electricity or gas system in that Member State. Such a specific measure should be without prejudice to Directive 2005/89/EC of the European Parliament and of the Council (10). (26) The competent authorities should cooperate closely with other relevant national authorities, in particular national regulatory authorities, when carrying out the tasks specified in this Regulation. (27) The infrastructure standard should oblige Member States to maintain a minimum level of infrastructure such as to ensure a degree of redundancy in the system in the event of a disruption of the single largest gas infrastructure. As an analysis conducted on the basis of the N – 1 formula constitutes a purely capacity-based-approach, the results of N – 1 formula should be complemented with a detailed analysis that also captures gas flows. (28) Regulation (EU) No 994/2010 requires transmission system operators to enable permanent physical bi-directional capacity on all cross-border interconnections unless an exemption has been granted from that obligation. It aims to ensure that the possible benefits of permanent bi-directional capacity are always taken into account when a new interconnection is planned. However, bi-directional capacity can be used to supply gas both to the neighbouring Member State and to others along the gas supply corridor. The benefits to the security of gas supply of enabling permanent physical bi-directional capacity need to be seen from a broader perspective, in a spirit of solidarity and enhanced cooperation. A comprehensive cost-benefit analysis that takes account of the whole transportation corridor should be conducted when considering whether to implement bi-directional capacity. The competent authorities concerned should be required to re-examine the exemptions granted under Regulation (EU) No 994/2010 on the basis of the results of the common risk assessments. The overall objective should be to have a growing bi-directional capacity and keep one-directional capacity in future cross-border projects to a minimum. (29) Capacity at an interconnection point to a Member State may compete with capacity at exit points from the gas grid into a gas storage facility. As a consequence, a situation could arise where firm booking of exit capacity into storage reduces the technically available capacity to be allocated at the interconnection point. In order to ensure a higher level of energy security in an emergency, this Regulation should provide for a clear priority rule. Any booked capacity at interconnection points should be given priority over competing capacity at an exit point into a storage facility, thereby enabling the transmission system operator to allocate the maximum technical capacity at the interconnection point in order to enable higher gas flows into the neighbouring Member State which has declared an emergency. This may have the consequence that gas injections into storage cannot take place or can take place only with reduced volumes despite being firmly booked in advance. To compensate for the resulting financial loss, this Regulation should provide for a fair compensation to be applied directly and promptly between the affected system users. The transmission system operators concerned should cooperate in accordance with the relevant legal acts in order to apply that priority rule. (30) Council Directive 2008/114/EC (11) lays down a process with a view to enhancing the security of designated European critical infrastructures, including certain gas infrastructure, in the Union. Directive 2008/114/EC together with this Regulation contributes to creating a comprehensive approach to the energy security of the Union. (31) This Regulation lays down security of supply standards that are sufficiently harmonised and cover at least the situation that occurred in January 2009 when gas supply from Russia was disrupted. Those standards take account of the difference between Member States, public service obligations and customer protection measures, as referred to in Article 3 of Directive 2009/73/EC. Security of supply standards should be stable, so as to provide the necessary legal certainty, should be clearly defined, and should not impose unreasonable and disproportionate burdens on natural gas undertakings. They should also guarantee equal access for the Union natural gas undertakings to national customers. Member States should establish measures that will, in an effective and proportionate manner, ensure that natural gas undertakings comply with such a standard, including the possibility to establish fines on suppliers, where they consider it to be appropriate. (32) The roles and responsibilities of all natural gas undertakings and competent authorities should be defined precisely in order to keep the internal gas market functioning properly, particularly in the event of supply disruptions and crises. Such roles and responsibilities should be established in such a way so as to ensure that a three-level approach is respected which would involve, first, the relevant natural gas undertakings and industry, second, Member States at national or regional level, and third, the Union. This Regulation should enable natural gas undertakings and customers to rely on market-based mechanisms for as long as possible when coping with disruptions. However, it should also provide for mechanisms that can be deployed when markets alone are no longer able to deal adequately with a disruption of gas supply. (33) In the event of a disruption of gas supply, market players should be given sufficient opportunity to respond to the situation with market-based measures. Where market-based measures have been exhausted and they are still insufficient, Member States and their competent authorities should take measures to remove or mitigate the effects of a disruption of gas supply. (34) Where Member States plan to introduce non-market-based measures, the introduction of such measures should be accompanied by a description of their economic impact. This ensures customers have the information they need about the costs of such measures and ensures that the measures are transparent, especially as regards their impact on the gas price. (35) The Commission should have the power to ensure that new preventive non-market-based measures do not endanger the security of gas supply of other Member States or in the Union. Given that such measures can be particularly damaging to the security of gas supply, it is appropriate that they enter into force only when they are approved by the Commission or have been amended in accordance with a Commission decision. (36) Demand-side measures, such as fuel switching or reducing the gas supply to large industrial customers in an economically efficient order, may have a valuable role to play in ensuring the security of gas supply, if they can be applied quickly and significantly reduce demand in response to a disruption of gas supply. More should be done to promote efficient energy use, particularly where demand-side measures are needed. The environmental impact of any demand and supply-side measures proposed should be taken into account, with preference being given, as far as possible, to measures that have least impact on the environment. At the same time, aspects of the security of gas supply and competitiveness should be taken into account. (37) It is necessary to ensure the predictability of the action to take in the event of an emergency, allowing all market participants sufficient opportunity to react to and prepare for such circumstances. As a rule, the competent authorities should therefore act in accordance with their emergency plan. In duly justified exceptional circumstances, they should be allowed to take action which deviates from those plans. It is also important to make the way in which emergencies are declared more transparent and predictable. Information on the system balancing position (the overall status of the transmission network), the framework for which is set out in Commission Regulation (EU) No 312/2014 (12), may play an important role in that regard. That information should be available to the competent authorities and, where they are not the competent authorities, the national regulatory authorities, on a real time basis. (38) As demonstrated in the context of the October 2014 stress test exercise, solidarity is needed to ensure the security of gas supply in the Union. It spreads effects out more evenly and reduces overall effects of a severe disruption. The solidarity mechanism is designed to address extreme situations in which supply to solidarityprotected customers as an essential need and a necessary priority is at stake in a Member State. Solidarity ensures cooperation with more vulnerable Member States. At the same time, solidarity is a measure of last resort that applies only in an emergency and only under restrictive conditions. If an emergency is declared in a Member State, a gradual and proportionate approach should therefore be applied to ensure the security of gas supply. The Member State that declared the emergency should, in particular, first implement all emergency measures provided for in its emergency plan in order to ensure gas supply to its solidarity protected customers. At the same time, all Member States which have introduced an increased supply standard should temporarily reduce it to the normal supply standard to make the gas market more liquid, in the event that the Member State declaring the emergency indicates that cross-border action is required. If those two sets of measures fail to provide the necessary supply, solidarity measures by directly connected Member States should be taken to ensure gas supply to solidarity protected customers in the Member State experiencing the emergency, at that Member State's request. Such solidarity measures should consist in ensuring that the gas supply to customers other than solidarity protected customers in the territory of the Member State providing solidarity is reduced or does not continue, in order to free up gas volumes, to the extent necessary and for as long as the gas supply to solidarity protected customers in the Member State requesting solidarity is not satisfied. Nothing in this Regulation should be understood as requiring or enabling a Member State to exercise public authority in another Member State. (39) Solidarity measures should also be taken as a last resort where a Member State is connected to another Member State via a third country unless flows are restricted through the third country, and where there is agreement of the relevant Member States, who should involve, as appropriate, the third country through which they are connected. (40) Where solidarity measures are taken as a last resort, the reduction or discontinuation of gas supply in the Member State providing solidarity should, where necessary for the Member State to comply with its solidarity obligations, and in order to avoid discriminatory treatment, be applicable to all customers which are not solidarity protected customers, irrespective of whether they receive gas directly or through solidarity protected district heating installations in the form of heating. The same should be ensured vice versa as regards customers, which are not solidarity protected customers in the Member State receiving gas under the solidarity mechanism. (41) Where solidarity measures are taken as a last resort, it is preferable that the gas consumption in the Member State providing solidarity is, as a first step, reduced on a voluntary basis, by means of market-based measures, such as voluntary demand-side measures or reversed auctions, in which certain customers such as industrial customers would indicate to the transmission system operator or another authority responsible the price at which they would reduce or stop their gas consumption. If market-based measures are found to be insufficient to address the deficit in required gas supply, and given the importance of solidarity measures as a last resort, the Member State providing solidarity should as a second step, be able to make use of non-market-based measures, including curtailment of certain groups of customers, in order to comply with its solidarity obligations. (42) Solidarity measures of a last resort should be provided on the basis of compensation. The Member State providing solidarity should be paid fair compensation promptly by the Member State receiving solidarity, including for the gas delivered into its territory and all other relevant and reasonable costs incurred when providing solidarity. Solidarity measures of a last resort should be subject to the condition that the Member State requesting solidarity undertakes to pay such fair and prompt compensation. This Regulation does not harmonise all aspects of fair compensation. Member States concerned should adopt the necessary measures, in particular technical, legal and financial arrangements, to implement the provisions on prompt and fair compensation between them. (43) When taking solidarity measures pursuant to the provisions of this Regulation, Member States are implementing Union law and are therefore bound to respect fundamental rights guaranteed by Union law. Such measures may therefore give rise to an obligation for a Member State to pay compensation to those affected by its measures. Member States should therefore ensure that national compensation rules are in place which are in conformity with Union law, in particular with fundamental rights. Moreover, it should be ensured that the Member State receiving solidarity ultimately bears all reasonable costs incurred from the said obligation on the Member State providing solidarity to pay compensation and further reasonable costs incurred from the payment of compensation pursuant to the said national compensation rules. (44) Since there may be more than one Member State providing solidarity to a requesting Member State, there should be a burden-sharing mechanism. Under that mechanism, the Member State requesting solidarity should, after consulting all Member States concerned, seek the most advantageous offer on the basis of cost, speed of delivery, reliability and diversification of supplies of gas from different Member States. The Member States should provide such offers on the basis of voluntary demand-side measures as much as and for as long as possible, before resorting to non-market-based measures. (45) This Regulation introduces, for the first time, such a solidarity mechanism between Member States as an instrument to mitigate the effects of a severe emergency within the Union including a burden-sharing mechanism. The Commission should therefore review the burden-sharing mechanism and the solidarity mechanism in general in the light of future experience with their functioning, and propose, where appropriate, modifications thereto. (46) Member States should adopt the necessary measures for the implementation of the provisions concerning the solidarity mechanism, including by the Member States concerned agreeing on technical, legal and financial arrangements. Member States should describe the details of those arrangements in their emergency plans. The Commission should prepare legally non-binding guidance concerning the key elements that should be included in such arrangements. (47) For as long as a Member State can cover the gas consumption of its solidarity protected customers from its own production and therefore does not need to request solidarity, it should be exempt from the obligation to conclude technical, legal and financial arrangements with other Member States for the purpose of it receiving solidarity. This should not affect the obligation of the relevant Member State to provide solidarity to other Member States. (48) There should be a safeguard for the event that the Union might incur costs by virtue of a liability, other than for unlawful acts or conduct pursuant to the second paragraph of Article 340 TFEU, in respect of measures that Member States are required to take pursuant to the provisions of this Regulation on the solidarity mechanism. Regarding such instances, it is appropriate that the Member State receiving solidarity reimburse the costs of the Union. (49) Solidarity should also, where needed, take the form of civil protection assistance provided by the Union and its Member States. Such assistance should be facilitated and coordinated by the Union Civil Protection Mechanism established by Decision No 1313/2013/EU aiming to strengthen the cooperation between the Union and the Member States and to facilitate coordination in the field of civil protection in order to improve the effectiveness of systems for preventing, preparing for, and responding to natural and man-made disasters. (50) To assess the security of gas supply of a Member State or in part or the whole of the Union, access to the relevant information is essential. In particular, Member States and the Commission need regular access to information from natural gas undertakings regarding the main parameters of the gas supply, including accurate measurements of the available stored reserves, as a fundamental input in the design of security of gas supply policies. On reasonable grounds, irrespective of a declaration of an emergency, access should also be possible to additional information needed to assess the overall gas supply situation. That additional information would typically be non-price-related gas delivery information, such as minimum and maximum gas volumes, delivery points or conditions for the suspension of gas deliveries. (51) An efficient and targeted mechanism for access by Member States and the Commission to key gas supply contracts should ensure a comprehensive assessment of relevant risks that can lead to a disruption of gas supply or interfere with the necessary mitigating measures should a crisis nevertheless occur. Under that mechanism, certain key gas supply contracts should be automatically notified, irrespective of the origin of the gas, within or outside the Union, to the competent authority of the most affected Member States. New contracts or modifications should be notified immediately after their conclusion. In order to ensure transparency and reliability, existing contracts should also be notified. The notification obligation should also cover all commercial agreements that are relevant for the execution of the gas supply contract, including relevant agreements that may be related to infrastructure, storage and any other aspect important for the security of gas supply. (52) Any obligation to notify a contract automatically to the competent authority needs to be proportionate. Applying that obligation to contracts between a supplier and a buyer covering the equivalent of 28 % or more of yearly gas consumption in the national market strikes the right balance in terms of administrative efficiency and transparency and lays down clear obligations for market participants. The competent authority should assess the contract for security of gas supply purposes and submit the results of the assessment to the Commission. If thecompetent authority has doubts as to whether a contract puts the security of gas supply of the Member State or a region at risk it should notify the contract to the Commission for assessment. This does not mean that other gas supply contracts are not relevant to the security of gas supply. Accordingly, where the competent authority of the most affected Member State or the Commission considers that a gas supply contract which is not subject to automatic notification under this Regulation might, due to its specificity, the customer group served, or its relevance for the security of gas supply, put at risk the security of gas supply of a Member State, of a region or of the Union, the competent authority or the Commission should be able to request that contract in order to assess its impact on the security of gas supply. It could, for example, be requested in the event of changes in the pattern of the gas supply to a given buyer or buyers in a Member State which would not be expected if the markets were functioning normally and which could affect the gas supply of the Union or parts of it. Such mechanism will ensure that the access to other key gas supply contracts relevant for the security of supply is guaranteed. Such a request should be reasoned, taking into account the need to limit the administrative burden of that measure as much as possible. (53) The Commission may propose that the Member States amend the risk assessments and the preventive action plans and the emergency plans so as to take account of the information obtained from the contracts. The provisions of this Regulation should be without prejudice to the right of the Commission to launch infringement proceedings in accordance with Article 258 TFEU and to enforce competition, including State aid, rules. (54) All contracts or contractual information received in that framework, including the assessments by the competent authority or the Commission, should remain confidential, in particular in order to protect commercially sensitive information and the integrity and proper functioning of the system of information exchange. Such confidentiality can also be relevant for public security given the importance an essential commodity such as gas may have for Member States. Moreover, meaningful and comprehensive assessments by the competent authorities or the Commission will contain, in particular, information relating to public security, commercial information or reference thereto. It is therefore necessary to ensure the confidentiality of the assessments. It is equally important that those who receive confidential information in accordance with this Regulation are bound by the obligation of professional secrecy. The Commission, competent authorities and national regulatory authorities, bodies or persons which receive confidential information pursuant to this Regulation should ensure the confidentiality of the information which they receive. (55) There should be a proportionate system of crisis management and information exchange based on three crisis levels: early warning, alert and emergency. Where the competent authority of a Member State declares one of the crisis levels, it should immediately inform the Commission as well as the competent authorities of the Member States to which the Member State of that competent authority is directly connected. In the case of a declaration of an emergency, the Member States in the risk group should also be informed. The Commission should declare a regional or Union emergency at the request of at least two competent authorities that have declared an emergency. To ensure an appropriate level of information exchange and cooperation in the case of regional or Union emergency the Commission should coordinate the action of the competent authorities, taking full account of relevant information from, and the results of, the consultation of the GCG. The Commission should declare an end to the regional or Union emergency if, after an assessment of the situation, it concludes that a declaration of an emergency is no longer justified. (56) The GCG should act as an adviser to the Commission to help coordinate security of gas supply measures in the event of a Union emergency. It should also monitor the adequacy and appropriateness of measures to be taken under this Regulation, including the consistency of preventive action plans and emergency plans drawn up by different risk groups. (57) A gas crisis could extend beyond Union borders, also comprising Energy Community Contracting Parties. As a Party to the Energy Community Treaty, the Union should promote amendments to that Treaty with the aim of creating an integrated market and a single regulatory space by providing an appropriate and stable regulatory framework. In order to ensure that an efficient crisis management on borders between the Member States and the Contracting Parties exists in the meantime, they are invited to closely cooperate when preventing, preparing for and handling a gas crisis. (58) Since gas supplies from third countries are central to the security of gas supply in the Union, the Commission should coordinate action with regard to third countries, work with supplying and transit countries on arrangements to handle crisis situations and ensure a stable gas flow to the Union. The Commission should beentitled to deploy a task force to monitor gas flows into the Union in crisis situations after consulting Member States and the third countries involved and, where a crisis arises from difficulties in a third country, to act as mediator and facilitator. The Commission should report regularly to the GCG. (59) Where there is reliable information on a situation outside the Union that threatens the security of gas supply of one or several Member States and that may trigger an early warning mechanism involving the Union and a third country, the Commission should inform the GCG without delay and the Union should take appropriate action to try to defuse the situation. (60) Since the objective of this Regulation, namely to safeguard the security of gas supply in the Union, cannot be sufficiently achieved by Member States acting on their own, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality set out in that Article, this Regulation does not go beyond what is necessary to achieve that objective. (61) In order to allow for a swift Union response to changing circumstances with regard to the security of gas supply, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the composition of the risk groups as well as templates for the risk assessments and for the preventive action plans and the emergency plans. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (13). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (62) Member States' right to determine the conditions for exploiting their energy resources in accordance with Article 194(2) TFEU is not affected by this Regulation. (63) Regulation (EU) No 994/2010 should be repealed. However, in order to avoid legal uncertainty, the preventive action plans and the emergency plans drawn up pursuant to that Regulation should remain in force until the new preventive action plans and emergency plans drawn up pursuant to this Regulation are adopted for the first time, HAVE ADOPTED THIS REGULATION: Article 1 Subject matter This Regulation establishes provisions aiming to safeguard the security of gas supply in the Union by ensuring the proper and continuous functioning of the internal market in natural gas (‘gas’), by allowing for exceptional measures to be implemented when the market can no longer deliver the gas supplies required, including solidarity measure of a last resort, and by providing for the clear definition and attribution of responsibilities among natural gas undertakings, the Member States and the Union regarding both preventive action and the reaction to concrete disruptions of gas supply. This Regulation also establishes transparent mechanisms concerning, in a spirit of solidarity, the coordination of planning for, and response to, emergencies at national, regional and Union level. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘security’ means security as defined in point 32 of Article 2 of Directive 2009/73/EC; (2) ‘customer’ means customer as defined in point 24 of Article 2 of Directive 2009/73/EC; (3) ‘household customer’ means household customer as defined in point 25 of Article 2 of Directive 2009/73/EC; (4) ‘essential social service’ means a service related to healthcare, essential social care, emergency, security, education or public administration; (5) ‘protected customer’ means a household customer who is connected to a gas distribution network and, in addition, where the Member State concerned so decides, may also mean one or more of the following, provided that enterprises or services as referred to in points (a) and (b) do not, jointly, represent more than 20 % of the total annual final gas consumption in that Member State: (a) a small or medium-sized enterprise, provided that it is connected to a gas distribution network; (b) an essential social service, provided that it is connected to a gas distribution or transmission network; (c) a district heating installation to the extent that it delivers heating to household customers, small or medium-sized enterprises, or essential social services, provided that such installation is not able to switch to other fuels than gas; (6) ‘solidarity protected customer’ means a household customer who is connected to a gas distribution network, and, in addition, may include one or both of the following: (a) a district heating installation if it is a protected customer in the relevant Member State and only in so far as it delivers heating to households or essential social services other than educational and public administration services; (b) an essential social service if it is a protected customer in the relevant Member State, other than educational and public administration services; (7) ‘competent authority’ means a national governmental authority or a national regulatory authority designated by a Member State to ensure the implementation of the measures provided for in this Regulation; (8) ‘national regulatory authority’ means a national regulatory authority designated in accordance with Article 39(1) of Directive 2009/73/EC; (9) ‘natural gas undertaking’ means natural gas undertaking as defined in point 1 of Article 2 of Directive 2009/73/EC; (10) ‘gas supply contract’ means gas supply contract as defined in point 34 of Article 2 of Directive 2009/73/EC; (11) ‘transmission’ means transmission as defined in point 3 of Article 2 of Directive 2009/73/EC; (12) ‘transmission system operator’ means transmission system operator as defined in point 4 of Article 2 of Directive 2009/73/EC; (13) ‘distribution’ means distribution as defined in point 5 of Article 2 of Directive 2009/73/EC; (14) ‘distribution system operator’ means distribution system operator as defined in point 6 of Article 2 of Directive 2009/73/EC; (15) ‘interconnector’ means interconnector as defined in point 17 of Article 2 of Directive 2009/73/EC; (16) ‘emergency supply corridors’ means Union gas supply routes that help Member States to better mitigate the effects of potential disruption of supply or infrastructure; (17) ‘storage capacity’ means storage capacity as defined in point 28 of Article 2 of Regulation (EC) No 715/2009; (18) ‘technical capacity’ means technical capacity as defined in point 18 of Article 2 of Regulation (EC) No 715/2009; (19) ‘firm capacity’ means firm capacity as defined in point 16 of Article 2 of Regulation (EC) No 715/2009; (20) ‘interruptible capacity’ means interruptible capacity as defined in point 13 of Article 2 of Regulation (EC) No 715/2009; (21) ‘LNG facility capacity’ means LNG facility capacity as defined in point 24 of Article 2 of Regulation (EC) No 715/2009; (22) ‘LNG facility’ means LNG facility as defined in point 11 of Article 2 of Directive 2009/73/EC; (23) ‘storage facility’ means storage facility as defined in point 9 of Article 2 of Directive 2009/73/EC; (24) ‘system’ means system as defined in point 13 of Article 2 of Directive 2009/73/EC; (25) ‘system user’ means system user as defined in point 23 of Article 2 of Directive 2009/73/EC; (26) ‘ancillary services’ means ancillary services as defined in point 14 of Article 2 of Directive 2009/73/EC. Article 3 Responsibility for the security of gas supply 1. The security of gas supply shall be the shared responsibility of natural gas undertakings, Member States, in particular through their competent authorities, and the Commission, within their respective areas of activity and competence. 2. Each Member State shall designate a competent authority. The competent authorities shall cooperate with each other in the implementation of this Regulation. Member States may allow the competent authority to delegate specific tasks set out in this Regulation to other bodies. Where competent authorities delegate the task of declaring any of the crisis levels referred to in Article 11(1), they shall do so only to a public authority, a transmission system operator or a distribution system operator. Delegated tasks shall be performed under the supervision of the competent authority and shall be specified in the preventive action plan and in the emergency plan. 3. Each Member State shall, without delay, notify the Commission, and make public, the name of its competent authority and any changes thereto. 4. When implementing the measures provided for in this Regulation, the competent authority shall establish the roles and responsibilities of the different actors concerned in such a way as to ensure a three-level approach which involves, first, the relevant natural gas undertakings, electricity undertakings where appropriate, and industry, second, Member States at national or regional level, and third, the Union. 5. The Commission shall coordinate the action of the competent authorities at regional and Union levels, pursuant to this Regulation, inter alia, through the GCG or, in particular, in the event of a regional or Union emergency pursuant to Article 12(1), through the crisis management group referred to in Article 12(4). 6. In the event of a regional or Union emergency, the transmission system operators shall cooperate and exchange information using the ReCo System for Gas established by ENTSOG. ENTSOG shall inform the Commission and the competent authorities of the Member States concerned accordingly. 7. In accordance with Article 7(2), major transnational risks to the security of gas supply in the Union are to be identified and risk groups are to be established on that basis. Those risk groups shall serve as the basis for enhanced regional cooperation to increase the security of gas supply and shall enable agreement on appropriate and effective cross-border measures of all Member States concerned within the risk groups or outside the risk groups along the emergency supply corridors. The list of such risk groups and their composition are set out in Annex I. The composition of the risk groups shall not prevent any other form of regional cooperation benefiting security of supply. 8. The Commission is empowered to adopt delegated acts in accordance with Article 19 in order to update the composition of the risk groups set out in Annex I by amending that Annex in order to reflect the evolution of the major transnational risks to the security of gas supply in the Union and its impact on Member States, taking into account the result of Union-wide simulation of gas supply and infrastructure disruption scenarios carried out by ENTSOG in accordance with Article 7(1). Before proceeding to the update, the Commission shall consult the GCG in the setting provided for in Article 4(4) on the draft update. Article 4 Gas Coordination Group 1. A Gas Coordination Group (GCG) shall be established to facilitate the coordination of measures concerning the security of gas supply. The GCG shall be composed of representatives of the Member States, in particular representatives of their competent authorities, as well as the Agency for the Cooperation of Energy Regulators (the ‘Agency’), ENTSOG and representative bodies of the industry concerned and those of relevant customers. The Commission shall, in consultation with the Member States, decide on the composition of the GCG, ensuring it is fully representative. The Commission shall chair the GCG. The GCG shall adopt its rules of procedure. 2. The GCG shall be consulted and shall assist the Commission in particular on the following issues: (a) the security of gas supply, at any time and more specifically in the event of an emergency; (b) all information relevant to the security of gas supply at national, regional and Union level; (c) best practices and possible guidelines to all the parties concerned; (d) the level of the security of gas supply, benchmarks and assessment methodologies; (e) national, regional and Union scenarios and testing the levels of preparedness; (f) the assessment of the preventive action plans and the emergency plans, the coherence across the various plans, and the implementation of the measures provided for therein; (g) the coordination of measures to deal with an Union emergency, with the Energy Community Contracting Parties and with other third countries; (h) assistance needed by the most affected Member States. 3. The Commission shall convene the GCG on a regular basis and shall share the information received from the competent authorities whilst preserving the confidentiality of commercially sensitive information. 4. The Commission may convene the GCG in a setting which is restricted to the representatives of the Member States and in particular of their competent authorities. The Commission shall convene the GCG in this restricted setting if so requested by one or more of the representatives of the Member States and in particular of their competent authorities. In this case, Article 16(2) shall not apply. Article 5 Infrastructure standard 1. Each Member State or, where a Member State so provides, its competent authority shall ensure that the necessary measures are taken so that in the event of a disruption of the single largest gas infrastructure, the technical capacity of the remaining infrastructure, determined in accordance with the N – 1 formula as set out in point 2 of Annex II, is able, without prejudice to paragraph 2 of this Article, to satisfy total gas demand of the calculated area during a day of exceptionally high gas demand occurring with a statistical probability of once in 20 years. This shall be done taking into account gas consumption trends, the long-term impact of energy efficiency measures and the utilisation rates of existing infrastructure. The obligation set out in the first subparagraph of this paragraph shall be without prejudice to the responsibility of the transmission system operators to make the corresponding investments and to the obligations of transmission system operators as laid down in Regulation (EC) No 715/2009 and Directive 2009/73/EC. 2. The obligation to ensure that the remaining infrastructure has the technical capacity to satisfy total gas demand, as referred to in paragraph 1 of this Article, shall also be considered to be fulfilled where the competent authority demonstrates in the preventive action plan that a disruption of gas supply may be sufficiently compensated for, in a timely manner, by appropriate market-based demand-side measures. For that purpose, the N – 1 formula shall be calculated as set out in point 4 of Annex II. 3. Where appropriate, in accordance with the risk assessments referred to in Article 7, the competent authorities of neighbouring Member States may agree to fulfil, jointly, the obligation set out in paragraph 1 of this Article. In such case the competent authorities shall provide in the risk assessment the calculation of the N – 1 formula together with an explanation in the regional chapters of the preventive action plans how the agreed arrangements fulfil that obligation. Point 5 of Annex II shall apply. 4. The transmission system operators shall enable permanent physical capacity to transport gas in both directions (‘bi-directional capacity’) on all interconnections between Member States, except: (a) in the case of connections to production facilities, to LNG facilities and to distribution networks; or (b) where an exemption from that obligation has been granted, after detailed assessment and after consulting other Member States and with the Commission in accordance with Annex III. For the procedure to enable or enhance bi-directional capacity on an interconnection or to obtain or prolong an exemption from that obligation Annex III shall apply. The Commission shall make public the list of exemptions and keep it updated. 5. A proposal for enabling or enhancing bi-directional capacity or a request for granting or prolongation of an exemption shall include a cost-benefit analysis prepared on the basis of the methodology pursuant to Article 11 of Regulation (EU) No 347/2013 of the European Parliament and of the Council (14) and shall be based on the following elements: (a) an assessment of market demand; (b) projections for demand and supply; (c) the possible economic impact on existing infrastructure; (d) a feasibility study; (e) the costs of bi-directional capacity including the necessary reinforcement of the transmission system; and (f) the benefits to the security of gas supply taking into account the possible contribution of bi-directional capacity to meeting the infrastructure standard set out in this Article. 6. National regulatory authorities shall take into account the efficiently incurred costs of fulfilling the obligation set out in paragraph 1 of this Article and the costs of enabling bi-directional capacity so as to grant appropriate incentives when fixing or approving, in a transparent and detailed manner, the tariffs or methodologies in accordance with Article 13 of Regulation (EC) No 715/2009 and Article 41(8) of Directive 2009/73/EC. 7. In so far as an investment for enabling or enhancing bi-directional capacity is not required by the market but is considered to be necessary for the security of gas supply purposes and where that investment incurs costs in more than one Member State or in one Member State for the benefit of another Member State, the national regulatory authorities of all Member States concerned shall take a coordinated decision on cost allocation before any investment decision is taken. The cost allocation shall take into account the principles described and the elements contained in Article 12(4) of Regulation (EU) No 347/2013, in particular the proportion of the benefits of the infrastructure investments for the increase of the security of gas supply of the Member States concerned as well as investments already made in the infrastructure in question. The cost allocation shall not unduly distort competition and the effective functioning of the internal market and shall seek to avoid any undue distortive effect on the market. 8. The competent authority shall ensure that any new transmission infrastructure contributes to the security of gas supply through the development of a well-connected network, including, where appropriate, by means of a sufficient number of cross-border entry and exit points relative to market demand and the risks identified. The competent authority shall assess in the risk assessment whether, with an integrated perspective on gas and electricity systems, internal bottlenecks exist and national entry capacity and infrastructure, in particular transmission networks, are capable of adapting the national and cross-border gas flows to the scenario of disruption of the single largest gas infrastructure at national level and the single largest gas infrastructure of common interest to the risk group identified in the risk assessment. 9. By way of exception from paragraph 1 of this Article, and subject to the conditions laid down in this paragraph, Luxembourg, Slovenia and Sweden shall not be bound by, but shall endeavour to meet, the obligation set out in that paragraph, while ensuring the gas supplies to protected customers in accordance with Article 6. The exception shall apply to Luxembourg provided it has: (a) at least two interconnectors with other Member States; (b) at least two different sources of gas supply; and (c) no gas storage facilities on its territory. The exception shall apply to Slovenia provided it has: (a) at least two interconnectors with other Member States; (b) at least two different sources of gas supply; and (c) no gas storage facilities or an LNG facility on its territory. The exception shall apply to Sweden provided it has: (a) no gas transit to other Member States on its territory; (b) an annual gross inland gas consumption of less than 2 Mtoe; and (c) less than 5 % of total primary energy consumption from gas. Luxembourg, Slovenia and Sweden shall inform the Commission of any change affecting the conditions laid down in this paragraph. The exception laid down in this paragraph shall cease to apply where at least one of those conditions is no longer fulfilled. As part of the national risk assessment carried out in accordance with Article 7(3) Luxembourg, Slovenia and Sweden shall describe the situation with respect to the respective conditions laid down in this paragraph and the prospects for compliance with the obligation in paragraph 1 of this Article, taking into account the economic impact of meeting the infrastructure standard, the gas market development and gas infrastructure projects in the risk group. On the basis of the information provided in the national risk assessment and if the respective conditions laid down in this paragraph are still met, the Commission may decide that the exception can continue to apply for four more years. In the event of a positive decision, the procedure set out in this subparagraph shall be repeated after four years. Article 6 Gas supply standard 1. The competent authority shall require the natural gas undertakings that it identifies, to take measures to ensure the gas supply to the protected customers of the Member State in each of the following cases: (a) extreme temperatures during a 7-day peak period occurring with a statistical probability of once in 20 years; (b) any period of 30 days of exceptionally high gas demand, occurring with a statistical probability of once in 20 years; (c) for a period of 30 days in the case of disruption of the single largest gas infrastructure under average winter conditions. By 2 February 2018, each Member State shall notify to the Commission its definition of protected customers, the annual gas consumption volumes of the protected customers and the percentage that those consumption volumes represent of the total annual final gas consumption in that Member State. Where a Member State includes in its definition of protected customers the categories referred to in point (5)(a) or (b) of Article 2, it shall specify the gas consumption volumes corresponding to customers belonging to those categories and the percentage that each of those groups of customers represents in total annual final gas consumption. The competent authority shall identify the natural gas undertakings referred to in the first subparagraph of this paragraph and shall specify them in the preventive action plan. Any new non-market-based measures envisaged to ensure the gas supply standard shall comply with the procedure established in Article 9(4) to (9). Member States may comply with the obligation laid down in the first subparagraph through the implementation of energy efficiency measures or by replacing the gas with a different source of energy, inter alia, renewable energy sources, to the extent that the same level of protection is achieved. 2. Any increased gas supply standard beyond the 30-day period referred to in points (b) and (c) of paragraph 1 or any additional obligation imposed for reasons of security of gas supply shall be based on the risk assessment, shall be reflected in the preventive action plan and shall: (a) comply with Article 8(1); (b) not impact negatively on the ability of any other Member State to supply gas to its protected customers in accordance with this Article in the event of a national, regional or Union emergency; and (c) comply with Article 12(5) in the event of a regional or Union emergency. The Commission may require a justification showing compliance of any measure referred to in the first subparagraph with the conditions laid down therein. Such a justification shall be made public by the competent authority of the Member State that introduces the measure. Any new non-market-based measure pursuant to the first subparagraph of this paragraph, adopted on or after 1 November 2017, shall comply with the procedure established in Article 9(4) to (9). 3. After the expiry of the periods laid down by the competent authority in accordance with paragraphs 1 and 2, or under more severe conditions than those laid down in paragraph 1, the competent authority and natural gas undertakings shall endeavour to maintain, as far as possible, the gas supply, in particular to protected customers. 4. The obligations imposed on natural gas undertakings for the fulfilment of the gas supply standards laid down in this Article shall be non-discriminatory and shall not impose an undue burden on those undertakings. 5. Natural gas undertakings shall be allowed to meet their obligations based on this Article at a regional or Union level, where appropriate. The competent authorities shall not require the gas supply standards laid down in this Article to be met based on infrastructure located only within their territory. 6. The competent authorities shall ensure that conditions for supplies to protected customers are established without prejudice to the proper functioning of the internal energy market and at a price respecting the market value of the supplies. Article 7 Risk assessment 1. By 1 November 2017, ENTSOG shall carry out a Union-wide simulation of gas supply and infrastructure disruption scenarios. The simulation shall include the identification and assessment of emergency gas supply corridors and shall also identify which Member States can address identified risks, including in relation to LNG. The gas supply and infrastructure disruption scenarios and the methodology for the simulation shall be defined by ENTSOG in cooperation with the GCG. ENTSOG shall ensure an appropriate level of transparency and access to the modelling assumptions used in its scenarios. The Union-wide simulation of gas supply and infrastructure disruption scenarios shall be repeated every four years unless circumstances warrant more frequent updates. 2. The competent authorities within each risk group listed in Annex I shall make a common assessment at risk group level (‘common risk assessment’) of all relevant risk factors such as natural disasters, technological, commercial, social, political and other risks, which could lead to the materialisation of the major transnational risk to the security of gas supply for which the risk group was created. The competent authorities shall take into account the results of the simulation referred to in paragraph 1 of this Article for the preparation of the risk assessments, preventive action plans and emergency plans. The competent authorities within each risk group shall agree on a cooperation mechanism to conduct the common risk assessment and report it to the GCG eleven months before the deadline for the notification of the common risk assessment and its updates. At the request of a competent authority the Commission may have a facilitating role in the preparation of the common risk assessment, in particular for the establishment of the cooperation mechanism. If competent authorities within a risk group do not agree on a cooperation mechanism, the Commission shall propose a cooperation mechanism for that risk group, after consulting the competent authorities concerned. The competent authorities concerned shall agree on a cooperation mechanism for that risk group taking utmost account of the Commission's proposal. 10 months before the deadline for the notification of the common risk assessment or its updates, each competent authority shall share and update, within the agreed cooperation mechanism, all national data necessary for the preparation of the common risk assessment, in particular for running the various scenarios referred to in point (c) of paragraph 4. 3. The competent authority of each Member State shall make a national risk assessment (‘national risk assessment’) of all relevant risks affecting the security of gas supply. Such assessment shall be fully consistent with the assumptions and results of the common risk assessment(s). 4. The risk assessments referred to in paragraphs 2 and 3 of this Article shall be carried out, as relevant, by: (a) using the standards specified in Articles 5 and 6. The risk assessment shall describe the calculation of the N – 1 formula at national level and where appropriate include a calculation of the N – 1 formula at regional level. The risk assessment shall also include the assumptions used, including where applicable those for the calculation of the N – 1 formula at regional level, and the data necessary for such calculation. The calculation of the N – 1 formula at national level shall be accompanied by a simulation of disruption of the single largest gas infrastructure using hydraulic modelling for the national territory as well as by a calculation of the N – 1 formula considering the level of gas in storages at 30 % and 100 % of the maximum working volume; (b) taking into account all relevant national and transnational circumstances, in particular market size, network configuration, actual flows, including outflows from the Member States concerned, the possibility of physical gas flows in both directions including the potential need for consequent reinforcement of the transmission system, the presence of production and storage and the role of gas in the energy mixes, in particular with respect to district heating and electricity generation and for the operation of industries, and safety and gas quality considerations; (c) running various scenarios of exceptionally high demand for gas and disruption of gas supply, taking into account the history, probability, season, frequency and duration of their occurrence and assessing their likely consequences, such as: (i) disruption of the infrastructure relevant to the security of gas supply, in particular transmission infrastructure, storages or LNG terminals, including the largest gas infrastructure identified for the calculation of N – 1 formula; and (ii) disruption of supplies from third-country suppliers, as well as, where appropriate, geopolitical risks; (d) identifying the interaction and correlation of risks among the Member States in the risk group and with other Member States or other risk groups, as appropriate, including, as regards interconnections, cross-border supplies, cross-border access to storage facilities and bi-directional capacity; (e) taking into account risks relating to the control of infrastructure relevant to the security of gas supply to the extent that they may involve, inter alia, risks of underinvestment, undermining diversification, misuse of existing infrastructure or an infringement of Union law; (f) taking into account the maximal interconnection capacity of each border entry and exit point and various filling levels for storage. 5. The common and national risk assessments shall be prepared in accordance with the relevant template set out in Annex IV or V. If necessary, Member States may include additional information. The Commission is empowered to adopt delegated acts in accordance with Article 19 in order to amend the templates set out in Annexes IV and V, after consulting the GCG, in order to reflect the experience gained in the application of this Regulation, and to reduce the administrative burden on Member States. 6. Natural gas undertakings, industrial gas customers, the relevant organisations representing the interests of household and industrial gas customers as well as Member States and, where they are not the competent authorities, the national regulatory authorities, shall cooperate with the competent authorities and provide them upon request with all necessary information for the common and national risk assessments. 7. By 1 October 2018 Member States shall notify to the Commission the first common risk assessment once agreed by all Member States in the risk group and the national risk assessments. The risk assessments shall be updated every four years thereafter unless circumstances warrant more frequent updates. The risk assessments shall take account of progress made in investments needed to cope with the infrastructure standard defined in Article 5 and of country-specific difficulties encountered in the implementation of new alternative solutions. They shall also build on the experience acquired through the simulation of the emergency plans contained in Article 10(3). Article 8 Establishment of preventive action plans and emergency plans 1. The measures to ensure the security of gas supply contained in a preventive action plan and an emergency plan shall be clearly defined, transparent, proportionate, non-discriminatory and verifiable, shall not unduly distort competition or the effective functioning of the internal market in gas and shall not endanger the security of gas supply of other Member States or of the Union. 2. The competent authority of each Member State shall, after consulting the natural gas undertakings, the relevant organisations representing the interests of household and industrial gas customers, including electricity producers, electricity transmission system operators, and, where it is not the competent authority, the national regulatory authority, establish: (a) a preventive action plan containing the measures needed to remove or mitigate the risks identified, including the effects of energy efficiency and demand-side measures in the common and nationals risk assessments and in accordance with Article 9; (b) an emergency plan containing the measures to be taken to remove or mitigate the impact of a disruption of gas supply in accordance with Article 10. 3. The preventive action plan and the emergency plan shall contain a regional chapter, or several regional chapters, where a Member State is a member of different risk groups as defined in Annex I. The regional chapters shall be developed jointly by all Member States in the risk group before incorporation in the respective national plans. The Commission shall act as a facilitator so as to enable that the regional chapters collectively enhance the security of gas supply in the Union, and, do not give rise to any contradiction, and to overcome any obstacles to cooperation. The regional chapters shall contain appropriate and effective cross-border measures, including in relation to LNG, subject to agreement between the Member States implementing the measures from the same or different risk groups affected by the measure on the basis of the simulation referred to in Article 7(1) and the common risk assessment. 4. The competent authorities shall report regularly to the GCG on the progress achieved on the preparation and adoption of the preventive action plans and the emergency plans, in particular the regional chapters. In particular, competent authorities shall agree on a cooperation mechanism for the preparation of the preventive action plan and the emergency plan, including the exchange of draft plans. They shall report to the GCG on such agreed cooperation mechanism 16 months before the deadline for agreement of those plans and the updates of those plans. The Commission may have a facilitating role in the preparation of the preventive action plan and the emergency plan, in particular for the establishment of the cooperation mechanism. If competent authorities within a risk group do not agree on a cooperation mechanism, the Commission shall propose a cooperation mechanism for that risk group. The competent authorities concerned shall agree on the cooperation mechanism for that risk group taking account of the Commission's proposal. The competent authorities shall ensure the regular monitoring of the implementation of the preventive action plan and the emergency plan. 5. The preventive action plan and the emergency plan shall be developed in accordance with the templates contained in Annexes VI and VII. The Commission is empowered to adopt delegated acts in accordance with Article 19 in order to amend the templates set out in Annexes VI and VII, after consulting the GCG, in order to reflect the experience gained in the application of this Regulation, and to reduce the administrative burden on Member States. 6. The competent authorities of neighbouring Member States shall in due time consult each other with a view to ensuring consistency between their preventive action plans and their emergency plans. The competent authorities shall, within each risk group, exchange draft preventive action plans and emergency plans with proposals for cooperation, at the latest five months before the deadline for submission of the plans. The final versions of the regional chapters referred to in paragraph 3 shall be agreed by all Member States in the risk group. The preventive action plans and emergency plans shall also contain the national measures necessary to implement and enforce the cross-border measures in the regional chapters. 7. The preventive action plans and the emergency plans shall be made public and notified to the Commission by 1 March 2019. The Commission shall inform the GCG about the notification of the plans and publish them on the Commission's website. Within four months of the notification by the competent authorities, the Commission shall assess the plans taking into account the views expressed in the GCG. 8. The Commission shall issue an opinion to the competent authority with the recommendation to review a preventive action plan or an emergency plan if one or more of the following applies: (a) it is not effective to mitigate the risks as identified in the risk assessment; (b) it is inconsistent with the risk scenarios assessed or with the plans of another Member State or a risk group; (c) it does not comply with the requirement laid down in paragraph 1 not unduly to distort competition or the effective functioning of the internal market; (d) it does not comply with the provisions of this Regulation or other provisions of Union law. 9. Within three months of notification of the Commission's opinion referred to in paragraph 8, the competent authority concerned shall notify the amended preventive action plan or the emergency plan to the Commission, or shall inform the Commission of the reasons for which it disagree with the recommendations. In the event of disagreement related to elements referred to in paragraph 8, the Commission may, within four months of the reply of the competent authority, withdraw its request or convene the competent authority and, where the Commission considers it to be necessary, the GCG, in order to consider the issue. The Commission shall set out its detailed reasons for requesting any amendments to the preventive action plan or the emergency plan. The competent authority concerned shall take full account of the detailed reasons of the Commission. Where applicable, the competent authority concerned shall without delay amend and make the amended preventive action plan or emergency plan public. Where the final position of the competent authority concerned diverges from the Commission's detailed reasons, that competent authority shall provide and make public, together with its position and the Commission's detailed reasons, the justification underlying its position within two months of receipt of the detailed reasons of the Commission. 10. For non-market-based measures adopted on or after 1 November 2017, the procedure set out in Article 9(4), (6), (8) and (9) shall apply. 11. The confidentiality of commercially sensitive information shall be preserved. 12. Preventive action plans and emergency plans developed under Regulation (EU) No 994/2010, updated in accordance with that Regulation, shall remain in force until the preventive action plans and the emergency plans referred to in paragraph 1 of this Article are established for the first time. Article 9 Content of preventive action plans 1. The preventive action plan shall contain: (a) the results of the risk assessment and a summary of the scenarios considered, as referred to in point (c) of Article 7(4); (b) the definition of protected customers and the information described in the second subparagraph of Article 6(1); (c) the measures, volumes and capacities needed to fulfil the infrastructure and gas supply standards laid down in Articles 5 and 6, including, where applicable, the extent to which demand-side measures can sufficiently compensate, in a timely manner, for a disruption of gas supply as referred to in Article 5(2), the identification of the single largest gas infrastructure of common interest in the case of the application of Article 5(3), the necessary gas volumes per category of protected customers and per scenario as referred to in Article 6(1), and any increased gas supply standard including any justification showing compliance with the conditions laid down in Article 6(2) and a description of a mechanism to reduce temporarily any increased gas supply standard or additional obligation in accordance with Article 11(3); (d) obligations imposed on natural gas undertakings, electricity undertakings where appropriate, and other relevant bodies likely to have an impact on the security of gas supply, such as obligations for the safe operation of the gas system; (e) other preventive measures designed to address the risks identified in the risk assessment, such as those relating to the need to enhance interconnections between neighbouring Member States, to further improve energy efficiency, to reduce gas demand and the possibility to diversify gas routes and sources of gas supply and the regional utilisation of existing storage and LNG capacities, if appropriate, in order to maintain gas supply to all customers as far as possible; (f) information on the economic impact, effectiveness and efficiency of the measures contained in the plan, including the obligations referred to in point (k); (g) a description of the effects of the measures contained in the plan on the functioning of the internal energy market as well as national markets, including the obligations referred to in point (k); (h) a description of the impact of the measures on the environment and on customers; (i) the mechanisms to be used for cooperation with other Member States, including the mechanisms for preparing and implementing preventive action plans and emergency plans; (j) information on existing and future interconnections and infrastructure, including those providing access to the internal market, cross-border flows, cross-border access to storage and LNG facilities and the bi-directional capacity, in particular in the event of an emergency; (k) information on all public service obligations that relate to the security of gas supply. Critical information relating to points (a), (c) and (d) of the first subparagraph which, if revealed, could endanger the security of gas supply, may be excluded. 2. The preventive action plan, in particular the actions to meet the infrastructure standard as laid down in Article 5, shall take into account the Union-wide TYNDP elaborated by ENTSOG pursuant to Article 8(10) of Regulation (EC) No 715/2009. 3. The preventive action plan shall be based primarily on market-based measures and shall not put an undue burden on natural gas undertakings, or negatively impact on the functioning of the internal market in gas. 4. Member States, and in particular their competent authorities, shall ensure that all preventive non-market-based measures, such as those referred to in Annex VIII, adopted on or after 1 November 2017, irrespective of whether they are part of the preventive action plan or adopted subsequently, comply with the criteria laid down in the first subparagraph of Article 6(2). 5. The competent authority shall make public any measure referred to in paragraph 4 which has not yet been included in the preventive action plan, and shall notify to the Commission the description of any such measure and of its impact on the national gas market and, to the extent possible, on the gas markets of other Member States. 6. If the Commission doubts whether a measure referred to in paragraph 4 of this Article complies with the criteria laid down in the first subparagraph of Article 6(2) it shall request from the Member State concerned the notification of an impact assessment. 7. An impact assessment pursuant to paragraph 6 shall cover at least the following: (a) the potential impact on the development of the national gas market and competition at national level; (b) the potential impact on the internal gas market; (c) the potential impact on the security of gas supply of neighbouring Member States, in particular for those measures that could reduce the liquidity in regional markets or restrict flows to neighbouring Member States; (d) the costs and benefits, assessed against alternative market-based-measures; (e) an assessment of necessity and proportionality in comparison with possible market-based measures; (f) an appreciation whether the measure ensures equal possibilities for all market participants; (g) a phase-out strategy, the expected duration of the envisaged measure and an appropriate review calendar. The analysis referred to in points (a) and (b) shall be carried out by the national regulatory authority. The impact assessment shall be made public by the competent authority and shall be notified to the Commission. 8. Where the Commission considers, based on the impact assessment, that the measure is likely to endanger the security of gas supply of other Member States or of the Union it shall take a decision within four months of notification of the impact assessment requiring, to the extent necessary, the amendment or withdrawal of the measure. The adopted measure shall enter into force only when it is approved by the Commission or has been amended in accordance with the Commission decision. The four-month period shall begin on the day following receipt of a complete notification. The four-month period may be extended with the consent of both the Commission and the competent authority. 9. Where the Commission considers, based on the impact assessment, that the measure does not comply with the criteria laid down in the first paragraph of Article 6(2) it may issue an opinion within four months of notification of the impact assessment. The procedure set out in Article 8(8) and (9) shall apply. The four-month period shall begin on the day following receipt of a complete notification. The four-month period may be extended with the consent of both the Commission and the competent authority. 10. Article 8(9) shall apply to any measure subject to paragraphs 6 to 9 of this Article. 11. The preventive action plan shall be updated every four years after 1 March 2019 or more frequently if the circumstances so warrant or at the Commission's request. The updated plan shall reflect the updated risk assessment and the results of the tests carried out in accordance with Article 10(3). Article 8 shall apply to the updated plan. Article 10 Content of emergency plans 1. The emergency plan shall: (a) build upon the crisis levels referred to in Article 11(1); (b) define the role and responsibilities of natural gas undertakings, transmission system operators for electricity if relevant and of industrial gas customers including relevant electricity producers, taking account of the different extent to which they are affected in the event of a disruption of gas supply, and their interaction with the competent authorities and where appropriate with the national regulatory authorities at each of the crisis levels referred to in Article 11(1); (c) define the role and responsibilities of the competent authorities and of the other bodies to which tasks have been delegated as referred to in Article 3(2) at each of the crisis levels referred to in Article 11(1); (d) ensure that natural gas undertakings and industrial gas customers including relevant electricity producers are given sufficient opportunity to respond to the crisis levels referred to in Article 11(1); (e) identify, if appropriate, the measures and actions to be taken to mitigate the potential impact of a disruption of gas supply on district heating and the supply of electricity generated from gas, including through an integrated view of energy systems operations across electricity and gas if relevant; (f) establish detailed procedures and measures to be followed for the crisis levels referred to in Article 11(1), including the corresponding schemes on information flows; (g) designate a crisis manager and define its role; (h) identify the contribution of market-based measures for coping with the situation at alert level and mitigating the situation at emergency level; (i) identify the contribution of non-market-based measures planned or to be implemented for the emergency level, and assess the degree to which the use of such non-market-based measures is necessary to cope with a crisis. The effects of the non-market-based measures shall be assessed and procedures for their implementation defined. Non-market-based measures are to be used only when market-based mechanisms alone can no longer ensure supplies, in particular to protected customers, or for the application of Article 13; (j) describe the mechanisms used to cooperate with other Member States for the crisis levels referred to in Article 11(1) and information exchange arrangements between the competent authorities; (k) detail the reporting obligations imposed on natural gas undertakings and, where appropriate, electricity undertakings at alert and emergency levels; (l) describe the technical or legal arrangements in place to prevent undue gas consumption of customers who are connected to a gas distribution or transmission network but not protected customers; (m) describe the technical, legal and financial arrangements in place to apply the solidarity obligations laid down in Article 13; (n) estimate the gas volumes that could be consumed by solidarity protected customers covering at least the cases described in Article 6(1); (o) establish a list of predefined actions to make gas available in the event of an emergency, including commercial agreements between the parties involved in such actions and the compensation mechanisms for natural gas undertakings where appropriate, taking due account of the confidentiality of sensitive data. Such actions may involve cross-border agreements between Member States and/or natural gas undertakings. In order to prevent undue gas consumption during an emergency, as referred to in point (l) of the first subparagraph, or during the application of the measures referred to in Article 11(3) and Article 13, the competent authority of the Member State concerned shall inform customers who are not protected customers that they are required to cease or reduce their gas consumption without creating technically unsafe situations. 2. The emergency plan shall be updated every four years after 1 March 2019 or more frequently if circumstances so warrant or at the Commission's request. The updated plan shall reflect the updated risk assessment and the results of the tests carried out in accordance with paragraph 3 of this Article. Article 8(4) to (11) shall apply to the updated plan. 3. The measures, actions and procedures contained in the emergency plan shall be tested at least once between its four-year updates referred to in paragraph 2. In order to test the emergency plan, the competent authority shall simulate high and medium impact scenarios and responses in real time in accordance with that emergency plan. The results of the tests shall be presented at the GCG by the competent authority. 4. The emergency plan shall ensure that cross-border access to infrastructure in accordance with Regulation (EC) No 715/2009 is maintained as far as technically and safely possible in the event of an emergency and shall not introduce any measure unduly restricting the flow of gas across borders. Article 11 Declaration of a crisis 1. There shall be the following three crisis levels: (a) early warning level (‘early warning’): where there is concrete, serious and reliable information that an event which is likely to result in significant deterioration of the gas supply situation may occur and is likely to lead to the alert or the emergency level being triggered; the early warning level may be activated by an early warning mechanism; (b) alert level (‘alert’): where a disruption of gas supply or exceptionally high gas demand which results in significant deterioration of the gas supply situation occurs but the market is still able to manage that disruption or demand without the need to resort to non-market-based measures; (c) emergency level (‘emergency’): where there is exceptionally high gas demand, significant disruption of gas supply or other significant deterioration of the gas supply situation and all relevant market-based measures have been implemented but the gas supply is insufficient to meet the remaining gas demand so that non-market-based measures have to be additionally introduced with a view, in particular, to safeguarding gas supplies to protected customers in accordance with Article 6. 2. When the competent authority declares one of the crisis levels referred to in paragraph 1, it shall immediately inform the Commission as well as the competent authorities of the Member States with which the Member State of that competent authority is directly connected and provide them with all the necessary information, in particular with information on the action it intends to take. In the event of an emergency which may result in a call for assistance from the Union and its Member States, the competent authority of the Member State concerned shall without delay notify the Commission's Emergency Response Coordination Centre (ERCC). 3. Where a Member State has declared an emergency and has indicated that cross-border action is required, any increased gas supply standard or additional obligation under Article 6(2) imposed on natural gas undertakings in other Member States in the same risk group shall be temporarily reduced to the level established in Article 6(1). The obligations laid down in the first subparagraph of this paragraph shall cease to apply immediately after the competent authority declares an end to an emergency, or the Commission concludes, in accordance with the first subparagraph of paragraph 8, that the declaration of an emergency is not or is no longer justified. 4. When the competent authority declares an emergency it shall follow the pre-defined action as set out in its emergency plan and shall immediately inform the Commission and the competent authorities in the risk group as well as the competent authorities of the Member States with which the Member State of that competent authority is directly connected in particular of the action it intends to take. In duly justified exceptional circumstances, the competent authority may take action deviating from the emergency plan. The competent authority shall immediately inform the Commission and the competent authorities in its risk group as set out in Annex I, as well as the competent authorities of the Member States with which the Member State of that competent authority is directly connected, of any such action and shall provide a justification for the deviation. 5. The transmission system operator shall ensure that when an emergency is declared in a neighbouring Member State, capacity at interconnection points to that Member State, irrespective of whether firm or interruptible, and whether it has been booked before or during the emergency, has priority over competing capacity at exit points into storage facilities. The system user of the prioritised capacity shall promptly pay fair compensation to the system user of the firm capacity for the financial loss incurred as a result of prioritisation including a proportionate reimbursement for the cost of the firm capacity being interrupted. The process of determining and paying the compensation shall not affect the implementation of the priority rule. 6. The Member States and, in particular, the competent authorities shall ensure that: (a) no measures are introduced which unduly restrict the flow of gas within the internal market at any time; (b) no measures are introduced that are likely seriously to endanger the gas supply situation in another Member State; and (c) cross-border access to infrastructure in accordance with Regulation (EC) No 715/2009 is maintained as far as technically and safely possible, in accordance with the emergency plan. 7. During an emergency and on reasonable grounds, upon a request of the relevant electricity or gas transmission system operator a Member State may decide to prioritise the gas supply to certain critical gas-fired power plants over the gas supply to certain categories of protected customers, if the lack of gas supply to such critical gas-fired power plants either: (a) could result in severe damage in the functioning of the electricity system; or (b) would hamper the production and/or transportation of gas. Member States shall base any such measure on the risk assessment. Critical gas-fired power plants as referred to in the first subparagraph shall be clearly identified together with the possible gas volumes that would be subject to such a measure and included in the regional chapters of the preventive action plans and emergency plans. Their identification shall be carried out in close cooperation with transmission system operators of the electricity system and the gas system of the Member State concerned. 8. The Commission shall verify, as soon as possible, but in any case within five days of receiving the information referred to in paragraph 2 from the competent authority, whether the declaration of an emergency is justified in accordance with point (c) of paragraph 1 and whether the measures taken follow as closely as possible the actions listed in the emergency plan and are not imposing an undue burden on natural gas undertakings and are in accordance with paragraph 6. The Commission may, at the request of another competent authority, natural gas undertakings or on its own initiative, request the competent authority to modify the measures where they are contrary to the conditions referred to in the first sentence of this paragraph. The Commission may also request the competent authority to declare an end to the emergency where it concludes that the declaration of an emergency is not or is no longer justified in accordance with point (c) of paragraph 1. Within three days of notification of the Commission request, the competent authority shall modify the measures and shall notify the Commission thereof, or shall inform the Commission of the reasons for which it disagrees with the request. In the latter case, the Commission may, within three days of being informed, amend or withdraw its request or, in order to consider the issue, convene the competent authority or, where appropriate, the competent authorities concerned, and, where the Commission considers it to be necessary, the GCG. The Commission shall set out its detailed reasons for requesting any modification to the action. The competent authority shall take full account of the position of the Commission. Where the final decision of the competent authority diverges from the Commission position, the competent authority shall provide the reasons underlying such decision. 9. When the competent authority declares an end to one of the crisis levels referred to in paragraph 1, it shall inform the Commission as well as the competent authorities of the Member States with which the Member State of that competent authority is directly connected. Article 12 Regional and Union emergency responses 1. The Commission may declare a regional or Union emergency at the request of a competent authority that has declared an emergency and following the verification in accordance with Article 11(8). The Commission shall declare, as appropriate, a regional or Union emergency at the request of at least two competent authorities that have declared an emergency and following the verification in accordance with Article 11(8), and where the reasons for such emergencies are linked. In all cases, when it declares a regional or Union emergency, the Commission, using the means of communication most appropriate to the situation, shall gather the views of, and take due account of all the relevant information provided by other competent authorities. When the Commission decides, following an assessment, that the underlying basis for the regional or Union emergency no longer justifies the declaration of an emergency, it shall declare an end to the regional or Union emergency and shall give its reasons and inform the Council of its decision. 2. The Commission shall convene the GCG as soon as it declares a regional or Union emergency. 3. In a regional or Union emergency, the Commission shall coordinate the action of the competent authorities, taking full account of relevant information from, and the results of, the consultation of the GCG. In particular, the Commission shall: (a) ensure the exchange of information; (b) ensure the consistency and effectiveness of action at Member State and regional levels in relation to the Union level; (c) coordinate the actions with regard to third countries. 4. The Commission may convene a crisis management group composed of the crisis managers referred to in point (g) of Article 10(1), of the Member States concerned by the emergency. The Commission, in agreement with the crisis managers, may invite other relevant stakeholders to participate. The Commission shall ensure that the GCG is informed regularly about the work undertaken by the crisis management group. 5. The Member States and in particular the competent authorities shall ensure that: (a) no measures are introduced which unduly restrict the flow of gas within the internal market at any time, in particular the flow of gas to the affected markets; (b) no measures are introduced that are likely seriously to endanger the gas supply situation in another Member State; and (c) cross-border access to infrastructure in accordance with Regulation (EC) No 715/2009 is maintained as far as technically and safely possible, in accordance with the emergency plan. 6. Where, at the request of a competent authority or a natural gas undertaking or on its own initiative, the Commission considers that, in a regional or Union emergency, action taken by a Member State or a competent authority or the behaviour of a natural gas undertaking is contrary to paragraph 5, the Commission shall request that Member State or competent authority to modify its action or to take action in order to ensure compliance with paragraph 5, informing it of the reasons therefor. Due account shall be taken of the need to operate the gas system safely at all times. Within three days of notification of the Commission request, the Member State or the competent authority shall modify its action and notify the Commission thereof, or shall inform the Commission of the reasons for which it disagrees with the request. In the latter case, the Commission may, within three days of being informed, amend or withdraw its request or convene the Member State or the competent authority and, where the Commission considers it to be necessary, the GCG in order to consider the issue. The Commission shall set out its detailed reasons for requesting any modification to the action. The Member State or the competent authority shall take full account of the position of the Commission. Where the final decision of the competent authority or the Member State diverges from the Commission position, the competent authority or the Member State shall provide the reasons underlying such decision. 7. The Commission, after consulting the GCG, shall establish a permanent reserve list for a monitoring task force consisting of industry experts and representatives of the Commission. The monitoring task force may be deployed outside the Union when necessary and shall monitor and report on the gas flows into the Union, in cooperation with the supplying and transiting third countries. 8. The competent authority shall provide to the Commission's ERCC the information on any need for assistance. ERCC shall assess the overall situation and advise on the assistance that should be provided to the most affected Member States, and where appropriate to third countries. Article 13 Solidarity 1. If a Member State has requested the application of the solidarity measure pursuant to this Article, a Member State which is directly connected to the requesting Member State or, where the Member State so provides, its competent authority or transmission system operator or distribution system operator shall as far as possible without creating unsafe situations, take the necessary measures to ensure that the gas supply to customers other than solidarity protected customers in its territory is reduced or does not continue to the extent necessary and for as long as the gas supply to solidarity protected customers in the requesting Member State is not satisfied. The requesting Member State shall ensure that the relevant volume of gas is effectively delivered to solidarity protected customers in its territory. In exceptional circumstances and upon a duly reasoned request by the relevant electricity or gas transmission system operator to its competent authority, the gas supply may also continue to certain critical gas-fired power plants as defined pursuant to Article 11(7) in the Member State providing solidarity if the lack of gas supply to such plants would result in severe damage in the functioning of the electricity system or would hamper the production and/or transportation of gas. 2. A Member State shall also provide the solidarity measure to another Member State to which it is connected via a third country unless flows are restricted through the third country. Such an extension of the measure shall be subject to the agreement of the relevant Member States, who shall involve, as appropriate, the third country through which they are connected. 3. A solidarity measure shall be taken as a last resort and shall apply only if the requesting Member State has: (a) not been able to cover the deficit in gas supply to its solidarity protected customers despite the application of the measure referred to in Article 11(3); (b) exhausted all market-based measures and all measures provided in its emergency plan; (c) notified an explicit request to the Commission and to the competent authorities of all Member States with which it is connected either directly or pursuant to paragraph 2 via a third country, accompanied by a description of the implemented measures referred to in point (b) of this paragraph; (d) undertaken to pay fair and prompt compensation to the Member State providing solidarity in accordance with paragraph 8. 4. If there is more than one Member State that could provide solidarity to a requesting Member State, the requesting Member State shall, after consulting all Member States required to provide solidarity, seek the most advantageous offer on the basis of cost, speed of delivery, reliability and diversification of supplies of gas. The Member States concerned shall make such offers on the basis of voluntary demand-side measures as much as and for as long as possible, before resorting to non-market-based measures. 5. Where market-based measures prove insufficient for the Member State providing solidarity to address the deficit in gas supply to solidarity protected customers in the requesting Member State, the Member State providing solidarity may introduce non-market-based measures in order to comply with the obligations laid down in paragraphs 1 and 2. 6. The competent authority of the requesting Member State shall immediately inform the Commission and the competent authorities of the Member States providing solidarity when gas supply to solidarity protected customers in its territory is satisfied or where the obligations under paragraphs 1 and 2 are, based on its needs, reduced, or where they are suspended at the request of the Member State receiving solidarity. 7. The obligations laid down in paragraphs 1 and 2 shall apply subject to the technically safe and reliable operation of the gas system of a Member State providing solidarity and the limit of the maximum interconnection export capability of the relevant Member State infrastructure towards the requesting Member State. Technical, legal and financial arrangements may reflect such circumstances in particular those under which the market will deliver up to maximum interconnection capacity. 8. Solidarity under this Regulation shall be provided on the basis of compensation. The Member State requesting solidarity shall promptly pay, or ensure prompt payment of, fair compensation to the Member State providing solidarity. Such fair compensation shall cover at least: (a) the gas delivered into the territory of the requesting Member State; (b) all other relevant and reasonable costs incurred when providing solidarity, including, where appropriate, costs of such measures that may have been established in advance; (c) reimbursement for any compensation resulting from judicial proceedings, arbitration proceedings or similar proceedings and settlements and related costs of such proceedings involving the Member State providing solidarity vis-a-vis entities involved in the provision of such solidarity. Fair compensation pursuant to the first subparagraph shall include, inter alia, all reasonable costs that the Member State providing solidarity incurs from an obligation to pay compensation by virtue of fundamental rights guaranteed by Union law and by virtue of the applicable international obligations when implementing this Article and further reasonable costs incurred from payment of compensation pursuant to national compensation rules. By 1 December 2018, the Member States shall adopt the necessary measures, in particular the technical, legal and financial arrangements pursuant to paragraph 10, to implement the first and second subparagraphs of this paragraph. Such measures may provide for the practical modalities of prompt payment. 9. Member States shall ensure that the provisions of this Article are implemented in conformity with the Treaties, the Charter of Fundamental Rights of the European Union, as well as the applicable international obligations. They shall take the necessary measures to that effect. 10. By 1 December 2018, the Member States shall adopt the necessary measures, including those agreed in technical, legal and financial arrangements, to ensure that gas is supplied to solidarity protected customers in the requesting Member State in accordance with paragraphs 1 and 2. The technical, legal and financial arrangements shall be agreed among the Member States which are directly connected or, in accordance with paragraph 2, via a third country, and shall be described in their respective emergency plans. Such arrangements may cover, among others, the following elements: (a) the operational safety of networks; (b) gas prices to be applied and/or the methodology for their setting, taking into account the impact on the functioning of the market; (c) the use of interconnections, including bi-directional capacity and underground gas storage; (d) gas volumes or the methodology for their setting; (e) categories of costs that will have to be covered by a fair and prompt compensation, that may include damages for curtailed industry; (f) an indication of the method how the fair compensation could be calculated. The financial arrangement agreed between Member States before solidarity is requested shall contain provisions that allow for the calculation of the fair compensation of at least all relevant and reasonable costs incurred when providing solidarity and an undertaking that such compensation will be paid. Any compensation mechanism shall provide incentives to participate in market-based solutions such as auctions and demand response mechanisms. It shall not create perverse incentives, including in financial terms, for market players to postpone their action until non-market-based measures are applied. All compensation mechanisms or at least their summary shall be included in the emergency plans. 11. For as long as a Member State can cover the gas consumption for its solidarity protected customers from its own production, it shall be exempt from the obligation to conclude technical, legal and financial arrangements with Member States with which it is directly connected or, in accordance with paragraph 2, via a third country, for the purpose of receiving solidarity. Such an exemption shall not affect the obligation of the relevant Member State to provide solidarity to other Member States pursuant to this Article. 12. By 1 December 2017 and after consulting the GCG, the Commission shall provide for legally non-binding guidance for the key elements of the technical, legal and financial arrangements especially on how to apply the elements described in paragraphs 8 and 10 in practice. 13. Where Member States do not agree on the necessary technical, legal and financial arrangements by 1 October 2018, the Commission may after consulting the competent authorities concerned, propose a framework for such measures setting out the necessary principles to make them operational which shall build on the Commission's guidance set out in paragraph 12. Member States shall finalise their arrangements by 1 December 2018 taking utmost account of the Commission's proposal. 14. The applicability of this Article shall not be affected if Member States fail to agree or finalise their technical, legal and financial arrangements. In such a situation the Member States concerned shall agree on the necessary ad hoc measures and the Member State requesting solidarity shall provide an undertaking in accordance with point (d) of paragraph 3. 15. The obligations laid down in paragraphs 1 and 2 of this Article shall cease to apply immediately after the declaration of the end of an emergency or the Commission concludes, in accordance with the first subparagraph of Article 11(8), that the declaration of an emergency is not or is no longer justified. 16. Where the Union incurs costs by virtue of any liability, other than for unlawful acts or conduct pursuant to the second paragraph of Article 340 TFEU, in respect of measures that Member States are required to take pursuant to this Article, those costs shall be reimbursed to it by the Member State receiving solidarity. Article 14 Information exchange 1. Where a Member State has declared one of the crisis levels referred to in Article 11(1), the natural gas undertakings concerned shall make available, on a daily basis, in particular the following information to the competent authority of the Member State concerned: (a) the daily gas demand and gas supply forecasts for the following three days, in million cubic metres per day (mcm/d); (b) the daily flow of gas at all cross-border entry and exit points as well as at all points connecting a production facility, a storage facility or an LNG terminal to the network, in million cubic metres per day (mcm/d); (c) the period, expressed in days, for which it is expected that supply of gas to protected customers can be ensured. 2. In the event of a regional or Union emergency, the Commission may request that the competent authority referred to in paragraph 1 provide it without delay with at least: (a) the information set out in paragraph 1; (b) information on the measures planned to be undertaken and those already implemented by the competent authority to mitigate the emergency, and information on their effectiveness; (c) the requests made for additional measures to be taken by other competent authorities; (d) the measures implemented at the request of other competent authorities. 3. After an emergency, the competent authority referred to in paragraph 1 shall, as soon as possible and at the latest six weeks after the lifting of the emergency, provide the Commission with a detailed assessment of the emergency and the effectiveness of the measures implemented, including an assessment of the economic impact of the emergency, the impact on the electricity sector and the assistance provided to or received from, the Union and its Member States. Such assessment shall be made available to the GCG and shall be reflected in the updates of the preventive action plans and the emergency plans. The Commission shall analyse the assessments of the competent authorities and shall inform the Member States, the European Parliament and the GCG of the results of its analysis in an aggregated form. 4. In duly justified circumstances irrespective of a declaration of an emergency, the competent authority of the most affected Member State may require natural gas undertakings to provide the information referred to in paragraph 1 or additional information necessary to assess the overall situation of the gas supply in the Member State or other Member States, including contractual information, other than price information. The Commission may request from the competent authorities the information provided by natural gas undertakings under this paragraph, provided that the same information has not been transmitted already to the Commission. 5. Where the Commission considers the gas supply in the Union or part of the Union to be at risk or is likely to be at risk that may lead to the declaration of one of the crisis levels referred to in Article 11(1), it may require the competent authorities concerned to collect and submit to the Commission information necessary to assess of the gas supply situation. The Commission shall share its assessment with the GCG. 6. In order for the competent authorities and the Commission to assess the security of gas supply situation at national, regional and Union level, each natural gas undertaking shall notify: (a) to the competent authority concerned the following details of gas supply contracts with a cross-border dimension and a duration of more than one year which it has concluded to procure gas: (i) contract duration; (ii) yearly contracted volumes; (iii) contracted maximum daily volumes in the event of an alert or emergency; (iv) contracted delivery points; (v) minimum daily and monthly gas volumes; (vi) conditions for the suspension of gas deliveries. (vii) an indication whether the contract individually or cumulatively with its contracts with the same supplier or its affiliates is equivalent to or exceeds the threshold of 28 % as referred to in point (b) of paragraph 6 in the most affected Member State. (b) to the competent authority of the most affected Member State immediately after their conclusion or modification its gas supply contracts with a duration of more than one year, concluded or modified on or after 1 November 2017 that individually or cumulatively with its contracts with the same supplier or its affiliates is equivalent to 28 % or more of yearly gas consumption in that Member State to be calculated on the basis of the most recent available data. In addition, by 2 November 2018 natural gas undertakings shall notify the competent authority of all existing contracts fulfilling the same conditions. The notification obligation shall not cover price information and shall not apply to the modifications related only to the gas price. The notification obligation shall also apply to all commercial agreements that are relevant for the execution of the gas supply contract excluding price information. The competent authority shall notify the data listed in point (a) of the first subparagraph to the Commission in an anonymised form. In the event of new contracts being concluded or changes being made to existing contracts, the whole set of data shall be notified by the end of September of the relevant year. Where the competent authority has doubts whether a given contract obtained under point (b) of the first subparagraph puts the security of gas supply of a Member State or a region at risk, it shall notify the contract to the Commission. 7. In circumstances duly justified by the need to guarantee transparency of key gas supply contracts relevant to the security of gas supply, and where the competent authority of the most affected Member State or the Commission considers that a gas supply contract may jeopardise the security of gas supply of a Member State, of a region or of the Union, the competent authority of the Member State or the Commission may request the natural gas undertaking to provide the contract, excluding price information, for the assessment of its impact on the security of gas supply. The request shall be reasoned and may cover also details of any other commercial agreements that are relevant for the execution of the gas supply contract excluding price information. The justification shall include the proportionality of the administrative burden involved. 8. The competent authorities that receive information on the basis of point (b) of paragraph 6 or paragraph 7 of this Article shall assess the received information for security of gas supply purposes within three months and submit the results of their assessment to the Commission. 9. The competent authority shall take into account the information received under this Article in the preparation of the risk assessment, preventive action plan and emergency plan or their respective updates. The Commission may adopt an opinion proposing to the competent authority to amend the risk assessments or plans on the basis of the information received under this Article. The competent authority concerned shall review the risk assessment and the plans concerned by the request in accordance with the procedure set out in Article 8(9). 10. By 2 May 2019, the Member States shall lay down the rules on penalties applicable to infringements by natural gas undertakings of paragraph 6 or 7 of this Article and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. 11. For the purpose of this Article, ‘the most affected Member State’ shall mean a Member State where a contract party of a given contract has the most of its sales of gas or customers located. 12. All contracts or contractual information received on the basis of paragraphs 6 and 7 as well as the respective assessments by the competent authorities or the Commission shall remain confidential. The competent authorities and the Commission shall ensure full confidentiality. Article 15 Professional secrecy 1. Any commercially sensitive information received, exchanged or transmitted pursuant to Article 14(4) to (8), and Article 18 excluding the results of the assessments referred to in Article 14(3) and (5) shall be confidential and subject to the conditions of professional secrecy laid down in this Article. 2. The obligation of professional secrecy shall apply to the following persons who receive confidential information in accordance with this Regulation: (a) persons who work or who have worked for the Commission; (b) auditors and experts instructed by the Commission; (c) persons who work or who have worked for the competent authorities and the national regulatory authorities or for other relevant authorities; (d) auditors and experts instructed by competent authorities and national regulatory authorities or by other relevant authorities. 3. Without prejudice to cases covered by criminal law, the other provisions of this Regulation or other relevant Union law, confidential information received by the persons referred to in paragraph 2 in the course of their duties may not be divulged to any other person or authority, except in summary or aggregate form such that an individual market participant or market place cannot be identified. 4. Without prejudice to cases covered by criminal law, the Commission, the competent authorities and the national regulatory authorities, bodies or persons which receive confidential information pursuant to this Regulation may use confidential information only in the performance of their duties and for the exercise of their functions. Other authorities, bodies or persons may use that information for the purpose for which it was provided to them or in the context of administrative or judicial proceedings specifically related to the exercise of their functions. Article 16 Cooperation with the Energy Community Contracting Parties 1. Where the Member States and the Energy Community Contracting Parties cooperate in the process of the establishment of risk assessments and preventive action plans and emergency plans, such cooperation may include, in particular, identifying the interaction and correlation of risks and consultations with a view to ensuring consistency of preventive action plans and emergency plans across the border. 2. With respect to paragraph 1, Energy Community Contracting Parties may participate in the GCG upon invitation by the Commission on all matters of mutual concern. Article 17 Monitoring by the Commission The Commission shall carry out continuous monitoring of security of gas supply measures and report regularly to the GCG. The Commission, on the basis of the assessments referred to in Article 8(7) shall, by 1 September 2023, draw conclusions as to possible means to enhance the security of gas supply at Union level and submit a report to the European Parliament and to the Council on the application of this Regulation, including, where necessary, legislative proposals to amend this Regulation. Article 18 Notifications The risk assessment, the preventive action plans, the emergency plans and all other documents shall be notified to the Commission electronically through the CIRCABC platform. All correspondence in connection with a notification shall be transmitted electronically. Article 19 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 3(8), Article 7(5) and Article 8(5) shall be conferred on the Commission for a period of five years from 1 November 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 3(8), Article 7(5) and Article 8(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 3(8), Article 7(5) and Article 8(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 20 Derogation 1. This Regulation shall not apply to Malta and Cyprus for as long as no gas is supplied on their respective territories. For Malta and Cyprus the obligations laid down in, and the choices those Member States are entitled to make pursuant to, the following provisions shall be fulfilled and made within the specified time calculated from the date when gas is first supplied on their respective territories: (a) for point 5 of Article 2, Article 3(2), Article 7(5) and point (a) of Article 14(6): 12 months; (b) for Article 6(1): 18 months; (c) for Article 8(7): 24 months; (d) for Article 5(4): 36 months; (e) for Article 5(1): 48 months. In order to fulfil the obligation contained in Article 5(1), Malta and Cyprus may apply the provisions contained in Article 5(2), including by using non-market-based demand-side measures. 2. Obligations related to the work of the risk groups set out in Articles 7 and 8 with regard to the Southern Gas Corridor and Eastern Mediterranean risk groups shall start to apply from the date when the major infrastructure/pipeline enters the test operation. 3. For as long as Sweden has access to gas via interconnections exclusively from Denmark as its only source of gas and its only possible provider of solidarity, Denmark and Sweden shall be exempted from the obligation in Article 13(10) to conclude technical, legal and financial arrangements for the purpose of Sweden providing solidarity to Denmark. This shall not affect the obligation of Denmark to provide solidarity and to conclude the necessary technical, legal and financial arrangements to that effect pursuant to Article 13. Article 21 Repeal Regulation (EU) No 994/2010 is repealed. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IX. Article 22 Entry into force This Regulation shall enter into force on the fourth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 November 2017. However, Article 13(1) to (6), the first and second subparagraphs of Article 13(8), and Article 13(14) and (15) shall apply from 1 December 2018. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 25 October 2017. For the European Parliament The President A. TAJANI For the Council The President M. MAASIKAS (1) OJ C 487, 28.12.2016, p. 70. (2) Position of the European Parliament of 12 September 2017 (not yet published in the Official Journal) and decision of the Council of 9 October 2017. (3) Directive 2009/72/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in electricity and repealing Directive 2003/54/EC (OJ L 211, 14.8.2009, p. 55). (4) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ L 211, 14.8.2009, p. 94). (5) Regulation (EC) No 713/2009 of the European Parliament and of the Council of 13 July 2009 establishing an Agency for the Cooperation of Energy Regulators (OJ L 211, 14.8.2009, p. 1). (6) Regulation (EC) No 714/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the network for cross-border exchanges in electricity and repealing Regulation (EC) No 1228/2003 (OJ L 211, 14.8.2009, p. 15). (7) Regulation (EC) No 715/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the natural gas transmission networks and repealing Regulation (EC) No 1775/2005 (OJ L 211, 14.8.2009, p. 36). (8) Regulation (EU) No 994/2010 of the European Parliament and of the Council of 20 October 2010 concerning measures to safeguard security of gas supply and repealing Council Directive 2004/67/EC (OJ L 295, 12.11.2010, p. 1). (9) Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924). (10) Directive 2005/89/EC of the European Parliament and of the Council of 18 January 2006 concerning measures to safeguard security of electricity supply and infrastructure investment (OJ L 33, 4.2.2006, p. 22). (11) Council Directive 2008/114/EC of 8 December 2008 on the identification and designation of European critical infrastructures and the assessment of the need to improve their protection (OJ L 345, 23.12.2008, p. 75). (12) Commission Regulation (EU) No 312/2014 of 26 March 2014 establishing a Network Code on Gas Balancing of Transmission Networks (OJ L 91, 27.3.2014, p. 15). (13) OJ L 123, 12.5.2016, p. 1. (14) Regulation (EU) No 347/2013 of the European Parliament and of the Council of 17 April 2013 on guidelines for trans-European energy infrastructure and repealing Decision No 1364/2006/EC and amending Regulation (EC) No 713/2009, (EC) No 714/2009 and (EC) No 715/2009 (OJ L 115, 25.4.2013, p. 39). ANNEX I Regional cooperation The risk groups of Member States that serve as the basis for risk associated cooperation as referred to in Article 3(7) are the following: 1. Eastern gas supply risk groups: (a) Ukraine: Bulgaria, Czech Republic, Germany, Greece, Croatia, Italy, Luxembourg, Hungary, Austria, Poland, Romania, Slovenia, Slovakia; (b) Belarus: Belgium, Czech Republic, Germany, Estonia, Latvia, Lithuania, Luxembourg, Netherlands, Poland, Slovakia; (c) Baltic Sea: Belgium, Czech Republic, Denmark, Germany, France, Luxembourg, Netherlands, Austria, Slovakia, Sweden; (d) North-Eastern: Estonia, Latvia, Lithuania, Finland; (e) Trans-Balkan: Bulgaria, Greece, Romania. 2. North Sea gas supply risk groups: (a) Norway: Belgium, Denmark, Germany, Ireland, Spain, France, Italy, Luxembourg, Netherlands, Portugal, Sweden, United Kingdom; (b) Low-calorific gas: Belgium, Germany, France, Netherlands; (c) Denmark: Denmark, Germany, Luxembourg, Netherlands, Sweden; (d) United Kingdom: Belgium, Germany, Ireland, Luxembourg, Netherlands, United Kingdom. 3. North African gas supply risk groups: (a) Algeria: Greece, Spain, France, Croatia, Italy, Malta, Austria, Portugal, Slovenia; (b) Libya: Croatia, Italy, Malta, Austria, Slovenia. 4. South-East gas supply risk groups: (a) Southern Gas Corridor — Caspian: Bulgaria, Greece, Croatia, Italy, Hungary, Malta, Austria, Romania, Slovenia, Slovakia; (b) Eastern Mediterranean: Greece, Italy, Cyprus, Malta. ANNEX II Calculation of the N – 1 formula 1. Definition of the N – 1 formula The N – 1 formula describes the ability of the technical capacity of the gas infrastructure to satisfy total gas demand in the calculated area in the event of disruption of the single largest gas infrastructure during a day of exceptionally high gas demand occurring with a statistical probability of once in 20 years. Gas infrastructure shall cover the gas transmission network including interconnections, as well as production, LNG and storage facilities connected to the calculated area. The technical capacity of all remaining available gas infrastructure in the event of disruption of the single largest gas infrastructure shall be at least equal to the sum of the total daily gas demand of the calculated area during a day of exceptionally high gas demand occurring with a statistical probability of once in 20 years. The results of the N – 1 formula, as calculated below, shall be at least equal to 100 %. 2. Calculation method of the N – 1 formula , N – 1 ≥ 100 % The parameters used for the calculation shall be clearly described and justified. For the calculation of the EPm, a detailed list of the entry points and their individual capacity shall be provided. 3. Definitions of the parameters of the N – 1 formula ‘Calculated area’ means a geographical area for which the N – 1 formula is calculated, as determined by the competent authority. Demand-side definition ‘Dmax’ means the total daily gas demand (in mcm/d) of the calculated area during a day of exceptionally high gas demand occurring with a statistical probability of once in 20 years. Supply-side definitions ‘EPm’: technical capacity of entry points (in mcm/d), other than production, LNG and storage facilities covered by Pm, LNGm and Sm, means the sum of the technical capacity of all border entry points capable of supplying gas to the calculated area. ‘Pm’: maximal technical production capability (in mcm/d) means the sum of the maximal technical daily production capability of all gas production facilities which can be delivered to the entry points in the calculated area. ‘Sm’: maximal technical storage deliverability (in mcm/d) means the sum of the maximal technical daily withdrawal capacity of all storage facilities which can be delivered to the entry points of the calculated area, taking into account their respective physical characteristics. ‘LNGm’: maximal technical LNG facility capacity (in mcm/d) means the sum of the maximal technical daily send-out capacities at all LNG facilities in the calculated area, taking into account critical elements like offloading, ancillary services, temporary storage and re-gasification of LNG as well as technical send-out capacity to the system. ‘Im’ means the technical capacity of the single largest gas infrastructure (in mcm/d) with the highest capacity to supply the calculated area. When several gas infrastructures are connected to a common upstream or downstream gas infrastructure and cannot be separately operated, they shall be considered as one single gas infrastructure. 4. Calculation of the N – 1 formula using demand-side measures , N – 1 ≥ 100 % Demand-side definition ‘Deff’ means the part (in mcm/d) of Dmax that in the case of a disruption of gas supply can be sufficiently and timely covered with market-based demand-side measures in accordance with point (c) of Article 9(1) and Article 5(2). 5. Calculation of the N – 1 formula at regional level The calculated area referred to in point 3 shall be extended to the appropriate regional level, where applicable, as determined by the competent authorities of the Member States concerned. The calculation may also extend to the regional level of the risk group, if so agreed with the competent authorities of the risk group. For the calculation of the N – 1 formula at regional level, the single largest gas infrastructure of common interest shall be used. The single largest gas infrastructure of common interest to a region shall be the largest gas infrastructure in the region that directly or indirectly contributes to gas supply to the Member States of that region and shall be defined in the risk assessment. The calculation of the N – 1 formula at regional level may replace the calculation of the N – 1 formula at national level only where the single largest gas infrastructure of common interest is of major importance for the gas supply of all Member States concerned in accordance with the common risk assessment. On the level of the risk group, for the calculations referred to in Article 7(4), the single largest gas infrastructure of common interest to the risk groups as listed in Annex I shall be used. ANNEX III Permanent bi-directional capacity 1. For the execution of the provisions set out in this Annex the national regulatory authority may act as the competent authority if so decided by the Member State. 2. To enable or enhance bi-directional capacity on an interconnection or to obtain or prolong an exemption from that obligation, transmission system operators on both sides of the interconnection shall submit to their competent authorities (‘competent authorities concerned’) and to their regulatory authorities (‘regulatory authorities concerned’) after consulting with all transmission system operators potentially concerned: (a) a proposal to enable permanent physical capacity to transport gas in both directions for permanent bi-directional capacity concerning the reverse direction (‘physical reverse flow capacity’); or (b) a request for an exemption from the obligation to enable bi-directional capacity. The transmission system operators shall endeavour to submit a joint proposal or request for exemption. In the case of a proposal to enable bi-directional capacity, the transmission system operators may make a substantiated proposal for a cross-border cost allocation. Such submission shall take place no later than 1 December 2018 for all interconnections that existed on 1 November 2017, and after completing the feasibility study phase but before the start of detailed technical design phase for new interconnections. 3. Upon receipt of the proposal or the exemption request the competent authorities concerned shall without delay consult the competent authorities and, where they are not the competent authorities, the national regulatory authorities, of the Member State that could, in accordance with the risk assessment, benefit from the reverse flow capacity, the Agency and the Commission on the proposal or the exemption request. The authorities consulted may issue an opinion within four months of receipt of the consultation request. 4. The regulatory authorities concerned shall within six months upon receipt of the joint proposal, pursuant to Article 5(6) and (7), after consulting the project promoters concerned, take coordinated decisions on the cross-border allocation of investment costs to be borne by each transmission system operator of the project. Where the regulatory authorities concerned have not reached an agreement within that deadline, they shall inform the competent authorities concerned without delay. 5. The competent authorities concerned shall on the basis of the risk assessment, the information listed in Article 5(5) of this Regulation, the opinions received following the consultation in accordance with point 3 of this Annex and taking into account the security of gas supply and the contribution to the internal gas market take a coordinated decision. That coordinated decision shall be taken within two months. The period of two months shall start to run after the four-month period allowed for the opinions referred to under point 3 of this Annex, unless all opinions have been received before, or after the six-month period referred to in point 4 of this Annex for regulatory authorities concerned to adopt a coordinated decision. The coordinated decision shall: (a) accept the proposal for bi-directional capacity. Such decision shall contain a cost benefit analysis, a timeline for implementation and the arrangements for its subsequent use and be accompanied by the coordinated decision on the cross-border cost allocation referred to in point 4 and prepared by the regulatory authorities concerned; (b) grant or prolong a temporary exemption for a maximum period of four years, if the cost-benefit analysis included in the decision shows that the reverse flow capacity would not enhance the security of gas supply of any relevant Member State or if the investment costs would significantly outweigh the prospective benefits for the security of gas supply; or (c) require the transmission system operators to amend and resubmit their proposal or exemption request within a maximum period of four months. 6. The competent authorities concerned shall submit the coordinated decision without delay to the competent authorities and national regulatory authorities who have submitted an opinion in accordance with point 3, the regulatory authorities concerned, the Agency and the Commission including the opinions received following the consultation in accordance with point 3. 7. Within two months of receipt of the coordinated decision, the competent authorities referred to in point 6 may present their objections to the coordinated decision and submit them to the competent authorities concerned that adopted it, the Agency and the Commission. The objections shall be limited to facts and assessment, in particular cross-border cost allocation that was not subject of consultation in accordance with point 3. 8. Within three months of receipt of the coordinated decision in accordance with point 6, the Agency shall issue an opinion on the elements of the coordinated decision taking into account any possible objection and submit the opinion to all competent authorities concerned and the competent authorities referred to in point 6 and to the Commission. 9. Within four months of receipt of the opinion issued by the Agency pursuant to point 8 the Commission may adopt a decision requesting modifications of the coordinated decision. Any such decision of the Commission shall be taken on the basis of: the criteria set out in point 5, the reasons for the decision of the authorities concerned and the opinion of the Agency. The competent authorities concerned shall comply with the request of the Commission by amending their decision within a period of four weeks. In the event that the Commission does not act within the aforementioned four months period, it shall be considered not to have raised objections to the decision of the competent authorities concerned. 10. If the competent authorities concerned were not able to adopt a coordinated decision within the deadline set out in point 5 or if the regulatory authorities concerned could not reach an agreement on the cost allocation within the deadline set out in point 4, the competent authorities concerned shall inform the Agency and the Commission at the latest on the day of the expiry of the deadline. Within four months of receipt of that information, the Commission, after possible consultation with the Agency, shall adopt a decision covering all elements of a coordinated decision listed in point 5 with the exception of a cross-border cost allocation and submit that decision to the competent authorities concerned and the Agency. 11. If the Commission decision pursuant to point 10 of this Annex, requires bi-directional capacity, the Agency shall adopt a decision covering the cross-border cost allocation in line with Article 5(7) of this Regulation within three months of receipt of the Commission decision. Before taking such a decision, the Agency shall consult the regulatory authorities concerned and the transmission system operators. The three-month period may be extended by an additional period of two months where the Agency has to request additional information. The additional period shall begin on the day following receipt of the complete information. 12. The Commission, the Agency, the competent authorities, the national regulatory authorities and the transmission system operators shall preserve the confidentiality of commercially sensitive information. 13. Exemptions from the obligation to enable bi-directional capacity granted under Regulation (EU) No 994/2010 shall remain valid unless the Commission or the other concerned Member State requests a revision or their duration expires. ANNEX IV Template for the common risk assessment The following template shall be completed in a language agreed within the risk group. General information — Member States in the risk group — Name of the competent authorities responsible for the preparation of the risk assessment (1) 1. Description of the system Provide a brief description of the gas system of the risk group, covering: (a) the main gas consumption figures (2): annual final gas consumption (bcm) and breakdown per type of customers (3), peak demand (total and breakdown per category of consumer in mcm/d); (b) a description of the functioning of the gas system in the risk group: main flows (entry/exit/transit), entry/exit point's infrastructure capacity to and out of the region and per Member State, including utilisation rate, LNG facilities (maximal daily capacity, utilisation rate and access regime), etc.; (c) a breakdown, to the extent possible, of gas import sources per country of origin (4); (d) a description of the role of storage facilities relevant for the risk group, including cross-border access: (i) the storage capacity (total and working gas) compared to heating season demand; (ii) the maximal daily withdrawal capacity at different filling levels (ideally with full storages and end-of-season levels); (e) a description of the role of domestic production in the risk group: (i) the volume of production with regard to the annual final gas consumption; (ii) the maximal daily production capacity; (f) a description of the role of gas in the electricity production (e.g. importance, role as a back-up for renewables), including gas-fired generating capacity (total (MWe) and as percentage of the total generating capacity) and cogeneration (total (MWe) and as percentage of the total generating capacity). 2. Infrastructure standard (Article 5) Describe the calculations of the N – 1 formula(s) at regional level for the risk group, if so agreed with the competent authorities of the risk group, and the existing bidirectional capacities, as follows: (a) N – 1 formula (i) the identification of the single largest gas infrastructure of common interest for the risk group; (ii) the calculation of the N – 1 formula at regional level; (iii) a description of the values used for all elements in the N – 1 formula, including intermediate figures used for the calculation (e.g. for EPm indicate the capacity of all entry points considered under this parameter); (iv) an indication of the methodologies and assumptions used, if any, for the calculation of parameters in the N – 1 formula (e.g. Dmax) (use annexes for detailed explanations); (b) bi-directional capacity (i) indicate the interconnection points equipped with bidirectional capacity and the maximal capacity of bi-directional flows; (ii) indicate the arrangements governing the use of the reverse flow capacity (e.g. interruptible capacity); (iii) indicate interconnection points where an exemption has been granted in accordance with Article 5(4), the duration of the exemption and the grounds on which it was granted. 3. Identification of risks Describe the major transnational risk for which the group was created as well as the risk factors at several instances which could make that risk materialise, their likelihood and consequences. Non-exhaustive list of risk factors that have to be included in the assessment only if applicable according to the relevant competent authority: (a) political — gas disruption from third countries because of different reasons, — political unrest (either in country of origin or in transit country), — war/civil war (either in country of origin or in transit country), — terrorism; (b) technological — explosion/fires, — fires (internal to a given facility), — leakages, — lack of adequate maintenance, — equipment malfunction (failure to start, failure during working time, etc.), — lack of electricity (or other energy source), — ICT failure (hardware or software failure, internet, SCADA problems, etc.), — cyber-attack, — impact due to excavation works (digging, piling), ground works, etc.; (c) commercial/market/financial — agreements with third-country suppliers, — commercial dispute, — control of infrastructure relevant for the security of gas supply by third-country entities, which may imply, among others, risks of underinvestment, undermining diversification or non-respect of Union law, — price volatility, — underinvestment, — sudden, unexpected peak demand, — other risks which could lead to structural underperformance; (d) social — strikes (in different related sectors, such as the gas sector, ports, transport, etc.), — sabotage, — vandalism, — theft; (e) natural — earthquakes, — landslides, — floods (heavy rain, river), — storms (sea), — avalanches, — extreme weather conditions, — fires (external to the facility, like nearby forests, grassland, etc.). Analysis (a) describe the major transnational risk and any other relevant risk factors for the risk group, including their likelihood and impact as well as the interaction and correlation of risks among Member States, as appropriate; (b) describe the criteria used to determine whether a system is exposed to high/unacceptable risks; (c) set a list of relevant risk scenarios in accordance with the sources of risks and describe how the selection was made; (d) indicate the extent to which scenarios prepared by ENTSOG have been considered. 4. Risk analysis and assessment Analyse the set of relevant risk scenarios identified under point 3. In the simulation of risk scenarios include the existing security of gas supply measures, such as, the infrastructure standard calculated using the N – 1 formula as set out in point 2 of Annex II, if appropriate, and the gas supply standard. Per risk scenario: (a) describe in detail the risk scenario, including all assumptions and, if applicable, the underlying methodologies for their calculation; (b) describe in detail the results of the simulation carried out, including a quantification of the impact (e.g. volumes of unserved gas, the socioeconomic impact, the impact on district heating, the impact on electricity generation). 5. Conclusions Describe the main results of the common risk assessment, including the identification of risk scenarios that require further action. (1) Where this task has been delegated by any competent authority, indicate the name of the body/(ies) responsible for the preparation of the present risk assessment on its behalf. (2) For the first assessment, include data from the last two years. For updates, include data from the last four years. (3) Including industrial customers, electricity generation, district heating, residential and services and other (please specify the type of customers included here). Indicate as well the volume of consumption of protected customers. (4) Describe the methodology applied. ANNEX V Template for the national risk assessment General information Name of the competent authority responsible for the preparation of the present risk assessment (1). 1. Description of the system 1.1. Provide a brief consolidated description of the regional gas system for each risk group (2) the Member State participates in, covering: (a) the main gas consumption figures (3): annual final gas consumption (bcm and MWh) and breakdown per type of customers (4), peak demand (total and breakdown per category of consumer in mcm/d); (b) a description of the functioning of the gas system(s) in the relevant risk groups: main flows (entry/exit/transit), entry/exit point's infrastructure capacity to and out of the risk groups' region(s) and per Member State, including utilisation rate, LNG facilities (maximal daily capacity, utilisation rate and access regime), etc.; (c) a breakdown, to the extent possible, of percentage gas import sources per country of origin (5); (d) a description of the role of storage facilities relevant for the risk group, including cross-border access: (i) the storage capacity (total and working gas) compared to heating season demand; (ii) the maximal daily withdrawal capacity at different filling levels (ideally with full storages and end-of-season levels); (e) a description of the role of domestic production in the risk group(s): (i) the volume of production with regard to the annual final gas consumption; (ii) the maximal daily production capacity and description of how it can cover maximum daily consumption; (f) a description of the role of gas in the electricity production (e.g. importance, role as a back-up for renewables), including gas-fired generating capacity (total (MWe) and as percentage of the total generating capacity) and cogeneration (total (MWe) and as percentage of the total generating capacity). 1.2. Provide a brief description of the gas system of the Member State, covering: (a) the main gas consumption figures: annual final gas consumption (bcm) and breakdown by type of customers, peak demand (mcm/d); (b) a description of the functioning of the gas system at national level, including infrastructure (to the extent not covered by point 1.1(b)). If applicable, include L-gas system; (c) the identification of the key infrastructure relevant for the security of gas supply; (d) a breakdown, to the extent possible, at national level of gas import sources per country of origin; (e) a description of the role of storage and include: (i) the storage capacity (total and working) compared to heating season demand; (ii) the maximal daily withdrawal capacity at different filling levels (ideally with full storages and end-of-season levels); (f) a description of the role of domestic production and include: (i) the volume of production with regard to the annual final gas consumption; (ii) the maximal daily production capacity; (g) a description of the role of gas in the electricity production (e.g. importance, role as a back-up for renewables), including gas-fired generating capacity (total (MWe) and as percentage of the total generating capacity) and cogeneration (total (MWe) and as percentage of the total generating capacity). 2. Infrastructure standard (Article 5) Describe how the infrastructure standard is complied with, including the main values used for the N – 1 formula and alternative options for its compliance (with directly connected Member States, demand-side measures) and the existing bidirectional capacities, as follows: (a) N – 1 formula (i) the identification of the single largest gas infrastructure; (ii) the calculation of the N – 1 formula at national level; (iii) a description of the values used for all elements in the N – 1 formula, including intermediate values used for their calculation (e.g. for EPm indicate the capacity of all entry points considered under this parameter); (iv) an indication of the methodologies used, if any, for the calculation of parameters in the N – 1 formula (e.g. Dmax) (use annexes for detailed explanations); (v) an explanation of the results of the calculation of the N – 1 formula considering the level of storages at 30 % and 100 % of the maximum working volume; (vi) an explanation of the main results of the simulation of the N – 1 formula using a hydraulic model; (vii) if so decided by the Member State, a calculation of the N – 1 formula using demand-side measures: — calculation of the N – 1 formula in accordance with point 2 of Annex II, — description of the values used for all elements in the N – 1 formula, including intermediate figures used for the calculation (if different to the figures described under point 2(a)(iii)), — indicate the methodologies used, if any, for the calculation of parameters in the N – 1 formula (e.g. Dmax) (use annexes for detailed explanations), — explain the market-based demand-side measures adopted/to be adopted to compensate a disruption of gas supply and its expected impact (Deff); (viii) if so agreed with the competent authorities of the relevant risk group(s) or with directly connected Member States, joint calculation(s) of the N – 1 formula: — calculation of the N – 1 formula in accordance with point 5 of Annex II, — description of the values used for all elements in the N – 1 formula, including intermediate values used for their calculation (if different to the figures described under point 2(a)(iii)), — indicate the methodologies and assumptions used, if any, for the calculation of parameters in the N – 1 formula (e.g. Dmax) (use annexes for detailed explanations), — explain the agreed arrangements to ensure compliance with the N – 1 formula; (b) bi-directional capacity (i) indicate the interconnection points equipped with bidirectional capacity and the maximal capacity of bi-directional flows; (ii) indicate the arrangements governing the use of the reverse flow capacity (e.g. interruptible capacity); (iii) indicate interconnection points where an exemption has been granted in accordance with Article 5(4), the duration of the exemption and the grounds on which it was granted. 3. Identification of risks Describe the risk factors which could have negative impact on the security of gas supply in the Member State, their likelihood and consequences. Non-exhaustive list of types of risk factors that have to be included in the assessment only if applicable according to the competent authority: (a) political — gas disruption from third countries because of different reasons, — political unrest (either in country of origin or in transit country), — war/civil war (either in country of origin or in transit country), — terrorism; (b) technological — explosion/fires, — fires (internal to a given facility), — leakages, — lack of adequate maintenance, — equipment malfunction (failure to start, failure during working time, etc.), — lack of electricity (or other energy source), — ICT failure (hardware or software failure, internet, SCADA problems, etc.), — cyber-attack, — impact due to excavation works (digging, piling), ground works, etc.; (c) commercial/market/financial — agreements with third-country suppliers, — commercial dispute, — control of infrastructure relevant for the security of gas supply by third-country entities, which may imply, among others, risks of underinvestment, undermining diversification or non-respect of Union law, — price volatility, — underinvestment, — sudden, unexpected peak demand, — other risks which could lead to structural underperformance; (d) social — strikes (in different related sectors, such as the gas sector, ports, transport, etc.), — sabotage, — vandalism, — theft; (e) natural — earthquakes, — landslides, — floods (heavy rain, river), — storms (sea), — avalanches, — extreme weather conditions, — fires (external to the facility, like nearby forests, grassland, etc.). Analysis (a) identify the relevant risk factors for the Member State, including their likelihood and impact; (b) describe the criteria used to determine whether a system is exposed to high/unacceptable risks; (c) set a list of relevant risk scenarios in accordance with the risk factors and their likelihood and describe how the selection was made. 4. Risk analysis and assessment Analyse the set of relevant risk scenarios identified under point 3. In the simulation of risk scenarios include the existing security of gas supply measures, such as the infrastructure standard calculated using the N – 1 formula as set out in point 2 of Annex II, and the gas supply standard. Per risk scenario: (a) describe in detail the risk scenario, including all assumptions and, if applicable, the underlying methodologies for their calculation; (b) describe in detail the results of the simulation carried out, including a quantification of the impact (e.g. volumes of unserved gas, the socioeconomic impact, the impact on district heating, the impact on electricity generation). 5. Conclusions Describe the main results of the common risk assessment the Member States has been involved in, including the identification of risk scenarios that require further action. (1) Where this task has been delegated by the competent authority, indicate the name of the body/(ies) responsible for the preparation of the present risk assessment on its behalf. (2) For the sake of simplicity, present the information at the highest level of the risk groups if possible and merge details as necessary. (3) For the first assessment, include data from the last two years. For updates, include data from the last four years. (4) Including industrial customers, electricity generation, district heating, residential and services and other (specify the type of customers included here). Indicate as well the volume of consumption of protected customers. (5) Describe the methodology applied. ANNEX VI Template for preventive action plan General information — Member States in the risk group — Name of the competent authority responsible for the preparation of the plan (1) 1. Description of the system 1.1. Provide a brief consolidated description of the regional gas system for each risk group (2) the Member States participates in, covering: (a) the main gas consumption figures (3): annual final gas consumption (bcm) and breakdown per type of customers (4), peak demand (total and breakdown per category of consumer in mcm/d); (b) a description of the functioning of the gas system in the risk groups: main flows (entry/exit/transit), entry/exit point's infrastructure capacity to and out of the risk group's region(s) and per Member State, including utilisation rate, LNG facilities (maximal daily capacity, utilisation rate and access regime), etc.; (c) a breakdown, to the extent possible, of gas import sources per country of origin (5); (d) a description of the role of storage facilities relevant for the region, including cross-border access: (i) the storage capacity (total and working gas) compared to heating season demand; (ii) the maximal daily withdrawal capacity at different filling levels (ideally with full storages and end-of-season levels); (e) a description of the role of domestic production in the region: (i) the volume of production with regard to the annual final gas consumption; (ii) the maximal daily production capacity; (f) a description of the role of gas in the electricity production (e.g. importance, role as a back-up for renewables), including gas-fired generating capacity (total (MWe) and as percentage of the total generating capacity) and cogeneration (total (MWe) and as percentage of the total generating capacity); (g) a description of the role of energy efficiency measures and their effect on annual final gas consumption. 1.2. Provide a brief description of the gas system per Member State, covering: (a) the main gas consumption figures: annual final gas consumption (bcm) and breakdown by type of customers, peak demand (mcm/d); (b) a description of the functioning of the gas system at national level, including infrastructure (to the extent not covered by point 1.1(b)); (c) the identification of the key infrastructure relevant for the security of supply; (d) a breakdown, to the extent possible, at national level of gas import sources per country of origin; (e) a description of the role of storage in the Member State and include: (i) the storage capacity (total and working) compared to heating season demand; (ii) the maximal daily withdrawal capacity at different filling levels (ideally with full storages and end-of-season levels); (f) a description of the role of domestic production and include: (i) the volume of production with regard to the annual final gas consumption; (ii) the maximal daily production capacity; (g) a description of the role of gas in the electricity production (e.g. importance, role as a back-up for renewables), including gas-fired generating capacity (total (MWe) and as percentage of the total generating capacity) and cogeneration (total (MWe) and as percentage of the total generating capacity); (h) a description of the role of energy efficiency measures and their effect on annual final gas consumption. 2. Summary of the risk assessment Describe briefly the results of the relevant common and national risk assessment carried out in accordance with Article 7, including: (a) a list of the scenarios assessed and a brief description of the assumptions applied for each one as well as the risks/shortcomings identified; (b) the main conclusions of the risk assessment. 3. Infrastructure standard (Article 5) Describe how the infrastructure standard is complied with, including the main values used for the N – 1 formula and alternative options for its compliance (with neighbouring Member States, demand-side measures) and the existing bidirectional capacities, as follows: 3.1. N – 1 formula (i) the identification of the single largest gas infrastructure of common interest for the region; (ii) the calculation of the N – 1 formula at regional level; (iii) a description of the values used for all elements in the N – 1 formula, including intermediate figures used for the calculation (e.g. for EPm indicate the capacity of all entry points considered under this parameter); (iv) an indication of the methodologies and assumptions used, if any, for the calculation of parameters in the N – 1 formula (e.g. Dmax) (use annexes for detailed explanations). 3.2. National level (a) N – 1 formula (i) the identification of the single largest gas infrastructure; (ii) the calculation of the N – 1 formula at national level; (iii) a description of the values used for all elements in the N – 1 formula, including intermediate values used for the calculation (e.g. for EPm indicate the capacity of all entry points considered under this parameter); (iv) an indication of the methodologies used, if any, for the calculation of parameters in the N – 1 formula (e.g. Dmax) (use annexes for detailed explanations); (v) if so decided by the Member State, calculation of the N – 1 formula using demand-side measures: — the calculation of the N – 1 formula in accordance with point 2 of Annex II, — a description of the values used for all elements in the N – 1 formula, including intermediate figures used for the calculation (if different to the figures described under point 3(a)(iii) of this Annex), — an indication of the methodologies used, if any, for the calculation of parameters in the N – 1 formula (e.g. Dmax) (use annexes for detailed explanations), — an explanation of the market-based demand-side measures adopted/to be adopted to compensate a disruption of gas supply and its expected impact (Deff); (vi) if so agreed with the competent authorities of the relevant risk group(s) or with the directly connected Member States, joint calculation(s) of the N – 1 formula: — the calculation of the N – 1 formula in accordance with point 5 of Annex II, — a description of the values used for all elements in the N – 1 formula, including intermediate values used for the calculation (if different to the figures described under point 3(a)(iii) of this Annex), — an indication of the methodologies and assumptions used, if any, for the calculation of parameters in the N – 1 formula (e.g. Dmax) (use annexes for detailed explanations), — an explanation of the agreed arrangements to ensure compliance with the N – 1 formula; (b) bi-directional capacity (i) indicate the interconnection points equipped with bidirectional capacity and the maximal capacity of bi-directional flows; (ii) indicate the arrangements governing the use of the reverse flow capacity (e.g. interruptible capacity); (iii) indicate interconnection points where an exemption has been granted in accordance with Article 5(4), the duration of the exemption and the grounds on which it was granted. 4. Compliance with the supply standard (Article 6) Describe the measures adopted in order to comply with the supply standard as well as with any increased supply standard or additional obligation imposed for reasons of security of gas supply: (a) definition of protected customers applied, including categories of customers covered and their annual gas consumption (per category, net value and percentage of the national annual final gas consumption); (b) gas volumes needed to comply with the supply standard in accordance with the scenarios described in the first subparagraph of Article 6(1); (c) capacity needed to comply with the supply standard in accordance with the scenarios described in the first subparagraph of Article 6(1); (d) measure(s) in place to comply with the supply standard: (i) a description of the measure(s); (ii) addressees; (iii) where it exists, describe any ex ante monitoring system for the compliance with the supply standard; (iv) sanctions regime, if applicable; (v) describe, per measure: — the economic impact, effectiveness and efficiency of the measure, — the impact of the measure on the environment, — impact of the measures on consumer, (vi) where non-market-based measures are applied (per measure): — justify why the measure is necessary (i.e. why security of supply cannot be achieved via market-based measures alone), — justify why the measure is proportionate (i.e. why the non-market-based measure is the least restrictive means to achieve the intended effect), — provide an analysis of the impact of such measure: (1) on other Member State's security of supply; (2) on the national market; (3) on the internal market; (vii) where measures introduced on or after 1 November 2017, please provide a short summary of the impact assessment or a link to the public impact assessment of the measure(s) carried out in accordance with Article 9(4); (e) if applicable, describe any increased supply standard or additional obligation imposed for reasons of security of gas supply: (i) a description of the measure(s); (ii) the mechanism to reduce it to usual values in a spirit of solidarity and in accordance with Article 13; (iii) if applicable, describe any new increased supply standard or additional obligation imposed for reasons of security of gas supply adopted on or after 1 November 2017; (iv) addressees; (v) affected gas volumes and capacities; (vi) indicate how that measure complies with the conditions laid down in Article 6(2). 5. Preventive measures Describe the preventive measures in place or to be adopted: (a) describe each of the preventive measures adopted per identified risk in accordance with the risk assessment, including a description of: (i) their national or regional dimension; (ii) their economic impact, effectiveness and efficiency; (iii) their impact on customers. Where appropriate, include: — measures to enhance interconnections between neighbouring Member States, — measures to diversify gas routes and sources of supply, — measures to protect key infrastructure relevant for the security of supply in relation to control by third-country entities (including, where relevant, general or sector-specific investment screening laws, special rights for certain shareholders, etc.); (b) describe other measures adopted for reasons other than the risk assessment but with a positive impact for the security of supply of the relevant risk group(s) Member State. (c) where non-market-based measures are applied (per measure): (i) justify why the measure is necessary (i.e. why the security of supply cannot be achieved via market-based measures alone); (ii) justify why the measure is proportionate (i.e. why the non-market-based measure is the least restrictive means to achieve the intended effect); (iii) provide an analysis of the impact of such measure: — justify why the measure is necessary (i.e. why the security of supply cannot be achieved via market-based measures alone), — justify why the measure is proportionate (i.e. why the non-market-based measure is the least restrictive means to achieve the intended effect), — provide an analysis of the impact of such measure: (1) on other Member State's security of supply; (2) on the national market; (3) on the internal market; (4) explain the extent to which efficiency measures, including on the demand side, have been considered to increase the security of supply; (5) explain the extent to which renewable energy sources have been considered to increase the security of supply. 6. Other measures and obligations (e.g. safety operation of the system) Describe other measures and obligations that have been imposed on natural gas undertakings and other relevant bodies likely to have an impact on the security of gas supply, such as obligations for the safe operation of the system, including who would be affected by that obligation as well as the gas volumes covered. Explain precisely when and how those measures would apply. 7. Infrastructure projects (a) describe future infrastructure projects, including Projects of Common Interests in the relevant risk groups, including an estimated timing for their deployment, capacities and estimated impact on the security of gas supply in the risk group; (b) indicate how the infrastructure projects take into account the Union-wide TYNDP elaborated by ENTSOG pursuant to Article 8(10) of Regulation (EC) No 715/2009. 8. Public service obligations related to the security of supply Indicate the existing public service obligations related to the security of supply and briefly describe them (use annexes for more detailed information). Explain clearly who has to comply with such obligations and how. If applicable, describe how and when those public service obligations would be triggered. 9. Stakeholder consultations In accordance with Article 8(2) of this Regulation, describe the mechanism used for and the results of the consultations carried out, for the development of the plan as well as the emergency plan, with: (a) gas undertakings; (b) relevant organisations representing the interests of households; (c) relevant organisations representing the interests of industrial gas customers, including electricity producers; (d) national regulatory authority. 10. Regional dimension Indicate any national circumstances and measures relevant for the security of supply and not covered in the previous sections of the plan. Indicate how the possible comments received following the consultation described in Article 8(2) have been considered. 11.1. Calculation of the N – 1 at the level of the risk group if so agreed by the competent authorities of the risk group N – 1 formula (a) the identification of the single largest gas infrastructure of common interest for the risk group; (b) the calculation of the N – 1 formula at the level of the risk group; (c) a description of the values used for all elements in the N – 1 formula, including intermediate figures used for the calculation (e.g. for EPm indicate the capacity of all entry points considered under this parameter); (d) an indication of the methodologies and assumptions used, if any, for the calculation of parameters in the N – 1 formula (e.g. Dmax) (use annexes for detailed explanations). 11.2. Mechanisms developed for cooperation Describe the mechanisms used for the cooperation among the Member States in the relevant risk groups, including for developing cross-border measures in the preventive action plan and the emergency plan. Describe the mechanisms used for the cooperation with other Member States in the design and adoption of the provisions necessary for the application of Article 13. 11.3. Preventive measures Describe the preventive measures in place or to be adopted in the risk group or as a result of regional agreements: (a) describe each of the preventive measures adopted per identified risk in accordance with the risk assessment, including a description of: (i) their impact in the Member States of the risk group; (ii) their economic impact, effectiveness and efficiency; (iii) their impact on the environment; (iv) their impact on customers. Where appropriate, include: — measures to enhance interconnections between neighbouring Member States, — measures to diversify gas routes and sources of supply, — measures to protect key infrastructure relevant for the security of supply in relation to control by third-country entities (including, where relevant, general or sector-specific investment screening laws, special rights for certain shareholders, etc.); (b) describe other measures adopted for reasons other than the risk assessment but with a positive impact for the security of supply of the risk group. (c) where non-market-based measures are applied (per measure): (i) justify why the measure is necessary (i.e. why the security of supply cannot be achieved via market-based measures alone); (ii) justify why the measure is proportionate (i.e. why the non-market-based measure is the least restrictive means to achieve the intended effect); (iii) provide an analysis of the impact of such a measure: — justify why the measure is necessary (i.e. why the security of supply cannot be achieved via market-based measures alone), — justify why the measure is proportionate (i.e. why the non-market-based measure is the least restrictive means to achieve the intended effect), — provide an analysis of the impact of such a measure: (1) on other Member State's security of supply; (2) on the national market; (3) on the internal market; (d) explain the extent to which efficiency measures, including on the demand side, have been considered to increase the security of supply; (e) explain the extent to which renewable energy sources have been considered to increase the security of supply. (1) Where this task has been delegated by any competent authority, indicate the name of the body/(ies) responsible for the preparation of this plan on its behalf. (2) For the sake of simplicity, present the information at the highest level of the risk groups if possible and merge details as necessary (3) For the first plan, include data from the last two years. For updates, include data from the last four years. (4) Including industrial customers, electricity generation, district heating, residential and services and other (please specify the type of customers included here). (5) Describe the methodology applied. ANNEX VII Template for emergency plan General information Name of the competent authority responsible for the preparation of the present plan (1) 1. Definition of crisis levels (a) indicate the body responsible for the declaration of each crisis level and the procedures to follow in each case for such declarations; (b) where they exist, include here indicators or parameters used to consider whether an event may result in a significant deterioration of the supply situation and to decide upon the declaration of a certain crisis level. 2. Measures to be adopted per crisis level (2) 2.1. Early Warning Describe the measures to be applied at this stage, indicating, per measure: (i) a brief description of the measure and main actors involved; (ii) describe the procedure to follow, if applicable; (iii) indicate the expected contribution of the measure to cope with the impact of any event or prepare ahead of its appearance; (iv) describe the flows of information among the actors involved. 2.2. Alert Level (a) describe the measures to be applied at this stage, indicating, per measure: (i) a brief description of the measure and main actors involved; (ii) describe the procedure to follow, if applicable; (iii) indicate the expected contribution of the measure to cope with the situation at alert level; (iv) describe the flows of information among the actors involved; (b) describe the reporting obligations imposed on natural gas undertakings at alert level. 2.3. Emergency Level (a) establish a list of predefined actions on the supply and demand side to make gas available in the event of an emergency, including commercial agreements between the parties involved in such actions and the compensation mechanisms for natural gas undertakings where appropriate; (b) describe the market-based measures to be applied at this stage, indicating, per measure: (i) a brief description of the measure and main actors involved; (ii) describe the procedure to follow; (iii) indicate the expected contribution of the measure to mitigate the situation at emergency level; (iv) describe the flows of information among the actors involved; (c) describe the non-market-based measures planned or to be implemented for the emergency level, indicating, per measure: (i) a brief description of the measure and main actors involved; (ii) provide an assessment of the necessity of such measure in order to cope with a crisis, including the degree of its use; (iii) describe in detail the procedure to implement the measure (e.g. what would trigger the introduction of this measure, who would take the decision); (iv) indicate the expected contribution of the measure to mitigate the situation at emergency level as a complement to market-based measures; (v) assess other effects of the measure; (vi) justify the compliance of the measure with the conditions laid down in Article 11(6); (vii) describe the flows of information among the actors involved; (d) describe reporting obligations imposed on natural gas undertakings. 3. Specific measures for the electricity and district heating (a) district heating (i) briefly indicate the likely impact of a disruption of gas supply in the district heating sector; (ii) indicate measures and actions to be taken to mitigate the potential impact of a disruption of gas supply on district heating. Alternatively, indicate why the adoption of specific measures is not appropriate; (b) supply of electricity generated from gas (i) briefly indicate the likely impact of a disruption of gas supply in the electricity sector; (ii) indicate measures and actions to be taken to mitigate the potential impact of a disruption of gas supply on the electricity sector. Alternatively, indicate why the adoption of specific measures is not appropriate; (iii) indicate the mechanisms/existing provisions to ensure appropriate coordination, including exchange of information, between main actors in the gas and electricity sectors, in particular transmission system operators at different crisis levels. 4. Crisis manager or team Indicate who the crisis manager is and define its role. 5. Roles and responsibilities of different actors (a) per crisis level, define the roles and responsibilities, including interactions with the competent authorities and, where appropriate, with the national regulatory authority, of: (i) natural gas undertakings; (ii) industrial customers; (iii) relevant electricity producers; (b) per crisis level, define the role and responsibilities of the competent authorities and the bodies to which tasks have been delegated. 6. Measures regarding undue consumption by customers who are not protected customers Describe measures in place to prevent to the extent possible and without endangering the safe and reliable operation of the gas system or creating unsafe situations, the consumption by customers who are not protected customers of gas supply intended for protected customers during an emergency. Indicate the nature of the measure (administrative, technical, etc.), main actors and the procedures to follow. 7. Emergency tests (a) indicate the calendar for the real time response simulations of emergency situations; (b) indicate actors involved, procedures and concrete high and medium impact scenarios simulated. For the updates of the emergency plan: describe briefly the tests carried out since the last emergency plan was presented and the main results. Indicate which measures have been adopted as a result of those tests. 8. Regional Dimension 8.1. Measures to be adopted per crisis level: 8.1.1. Early Warning Describe the measures to be applied at this stage, indicating, per measure: (i) brief description of the measure and main actors involved; (ii) describe the procedure to follow, if applicable; (iii) indicate the expected contribution of the measure to cope with the impact of any event or prepare ahead of its appearance; (iv) describe the flows of information among the actors involved. 8.1.2. Alert Level (a) describe the measures to be applied at this stage, indicating, per measure: (i) brief description of the measure and main actors involved; (ii) describe the procedure to follow, if applicable; (iii) indicate the expected contribution of the measure to cope with the impact of any event or prepare ahead of its appearance; (iv) describe the flows of information among the actors involved; (b) describe the reporting obligations imposed on natural gas undertakings at alert. level. 8.1.3. Emergency Level (a) establish a list of predefined actions on the supply and demand side to make gas available in the event of an emergency, including commercial agreements between the parties involved in such actions and the compensation mechanisms for natural gas undertakings where appropriate; (b) describe the market-based measures to be applied at this stage, indicating, per measure: (i) brief description of the measure and main actors involved; (ii) describe the procedure to follow; (iii) indicate the expected contribution of the measure to mitigate the situation at emergency level; (iv) describe the flows of information among the actors involved; (c) describe the non-market-based measures planned or to be implemented for the emergency level, indicating, per measure: (i) brief description of the measure and main actors involved; (ii) provide an assessment of the necessity of such measure in order to cope with a crisis, including the degree of its use; (iii) describe in detail the procedure to implement the measure (e.g. what would trigger the introduction of the measure, who would take the decision); (iv) indicate the expected contribution of the measure to mitigate the situation at emergency level as a complement to market-based measures; (v) assess other effects of the measure; (vi) justify the compliance of the measure with the conditions established in Article 11(6); (vii) describe the flows of information among the actors involved; (d) describe reporting obligations imposed on natural gas undertakings. 8.2. Cooperation mechanisms (a) describe the mechanisms in place to cooperate within each of the relevant risk groups and to ensure appropriate coordination for each crisis level. Describe, to the extent they exist and have not been covered in point 2, the decision-making procedures for appropriate reaction at regional level at each crisis level; (b) describe the mechanisms in place to cooperate with other Member States out of the risk groups and to coordinate actions for each crisis level. 8.3. Solidarity among Member States (a) describe the agreed arrangements among directly connected Member States to ensure the application of the solidarity principle referred to in Article 13; (b) if applicable, describe the agreed arrangements between Members States that are connected to each other via a third country to ensure the application of the solidarity principle referred to in Article 13. (1) Where this task has been delegated by any competent authority, please indicate the name of the body/(ies) responsible for the preparation of this plan on its behalf. (2) Include regional and national measures. ANNEX VIII List of non-market-based security of gas supply measures In developing the preventive action plan and the emergency plan the competent authority shall consider the contribution of the following indicative and non-exhaustive list of measures only in the event of an emergency: (a) supply-side measures: — use of strategic gas storage, — enforced use of stocks of alternative fuels (e.g. in accordance with Council Directive 2009/119/EC (1)), — enforced use of electricity generated from sources other than gas, — enforced increase of gas production levels, — enforced storage withdrawal; (b) demand-side measures: — various steps of compulsory demand reduction including: — enforced fuel switching, — enforced utilisation of interruptible contracts, where not fully utilised as part of market-based measures, — enforced firm load shedding. (1) Council Directive 2009/119/EC of 14 September 2009 imposing an obligation on Member States to maintain minimum stocks of crude oil and/or petroleum products (OJ L 265, 9.10.2009, p. 9). ANNEX IX Correlation table Regulation (EU) No 994/2010 This Regulation Article 1 Article 1 Article 2 Article 2 Article 3 Article 3 Article 6 Article 5 Article 8 Article 6 Article 9 Article 7 Article 4 Article 8 Article 5 Article 9 Article 10 Article 10 Article 10 Article 11 Article 11 Article 12 — Article 13 Article 13 Article 14 Article 12 Article 4 — Article 15 — Article 16 Article 14 Article 17 — Article 18 — Article 19 Article 16 Article 20 Article 15 Article 21 Article 17 Article 22 Annex I Annex II Article 7 Annex III Annex IV Annex I — Annex IV — Annex V — Annex VI — Annex VII Annex II — Annex III Annex VIII — Annex IX

Gas supply security in the EU Gas supply security in the EU SUMMARY OF: Regulation 2017/1938 aiming to safeguard an uninterrupted supply of gas throughout the EU WHAT IS THE AIM OF THIS REGULATION? It aims to strengthen EU energy security by helping prevent potential supply disruptions — and to respond to them when they occur — to ensure that households and other vulnerable consumers are always supplied. The regulation forms part of the Energy Union package, which aims to make energy secure, affordable and sustainable through closer cooperation between EU countries. KEY POINTS Gas security of supply is the shared responsibility of natural gas companies, EU countries and the European Commission. The main elements of the regulation are: better cooperation and coordination between groups of EU countries in regional groups to assess common supply risks together and to develop and agree on joint preventive and emergency measures; introduction of the solidarity mechanism through which EU countries must help each other to always guarantee gas supply to the most vulnerable consumers — even in severe gas supply situations — under fair compensation conditions by the country receiving solidarity; improvement of transparency thanks to the obligation placed on gas companies to notify to their national authority their major long-term gas supply contracts that may be relevant for security of supply; the European Network of Transmission System Operators (ENTSOG) will carry out a 4-yearly EU-wide simulation of gas supply and infrastructure disruption scenarios; EU countries have specific obligations to the Energy Community, with the Commission coordinating the legal rules. Repeal The regulation repeals Regulation (EU) No 994/2010. FROM WHEN DOES THIS REGULATION APPLY? It has applied since 1 November 2017. BACKGROUND For more information, see: Secure gas supplies (European Commission). MAIN DOCUMENT Regulation (EU) 2017/1938 of the European Parliament and of the Council of 25 October 2017 concerning measures to safeguard the security of gas supply and repealing Regulation (EU) No 994/2010 (OJ L 280, 28.10.2017, pp. 1-56) RELATED DOCUMENTS Communication from the Commission the European Parliament, the Council, the European Economic and Social Committee, the Committee of the Regions and the European Investment Bank – Framework Strategy for a Resilient Energy Union with a Forward-Looking Climate Change Policy (COM(2015) 80 final, 25.2.2015) Regulation (EU) No 347/2013 of the European Parliament and of the Council of 17 April 2013 on guidelines for trans-European energy infrastructure and repealing Decision No 1364/2006/EC and amending Regulations (EC) No 713/2009, (EC) No 714/2009 and (EC) No 715/2009 (OJ L 115, 25.4.2013, pp. 39-75) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ L 211, 14.8.2009, pp. 94-136) last update 30.08.2018

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21.11.2018 EN Official Journal of the European Union L 295/138 REGULATION (EU) 2018/1727 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 85 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Acting in accordance with the ordinary legislative procedure (1), Whereas: (1) Eurojust was set up by Council Decision 2002/187/JHA (2) as a Union body with legal personality, to stimulate and to improve coordination and cooperation between competent judicial authorities of the Member States, particularly in relation to serious organised crime. Eurojust’s legal framework has been amended by Council Decisions 2003/659/JHA (3) and 2009/426/JHA (4). (2) Article 85 of the Treaty on the Functioning of the European Union (TFEU) provides for Eurojust to be governed by a regulation, adopted in accordance with the ordinary legislative procedure. It also requires determining arrangements for involving the European Parliament and national parliaments in the evaluation of Eurojust’s activities. (3) Article 85 TFEU also provides that Eurojust’s mission is to support and strengthen coordination and cooperation between national investigating and prosecuting authorities in relation to serious crime affecting two or more Member States or requiring prosecution on common bases, on the basis of operations conducted and information supplied by the Member States’ authorities and by the European Union Agency for Law Enforcement Cooperation (Europol). (4) This Regulation aims to amend and expand the provisions of Decision 2002/187/JHA. Since the amendments to be made are of substantial number and nature, Decision 2002/187/JHA should in the interests of clarity be replaced in its entirety in relation to the Member States bound by this Regulation. (5) As the European Public Prosecutor’s Office (EPPO) has been established by means of enhanced cooperation, Council Regulation (EU) 2017/1939 (5) is binding in its entirety and directly applicable only to Member States that participate in enhanced cooperation. Therefore, for those Member States which do not participate in the EPPO, Eurojust remains fully competent for forms of serious crime listed in Annex I to this Regulation. (6) Article 4(3) of the Treaty on European Union (TEU) recalls the principle of sincere cooperation by virtue of which the Union and the Member States are, in full mutual respect, to assist each other in carrying out tasks which flow from the TEU and the TFEU. (7) In order to facilitate cooperation between Eurojust and the EPPO, Eurojust should address issues of relevance to the EPPO whenever necessary. (8) In light of the establishment of the EPPO by means of enhanced cooperation, the division of competences between the EPPO and Eurojust with respect to crimes affecting the financial interests of the Union needs to be clearly established. From the date on which the EPPO assumes its tasks, Eurojust should be able to exercise its competence in cases which concern crimes for which the EPPO is competent, where those crimes involve both Member States which participate in enhanced cooperation on the establishment of the EPPO and Member States which do not participate in such enhanced cooperation. In such cases, Eurojust should act at the request of the non-participating Member States or at the request of the EPPO. Eurojust should in any case remain competent for offences affecting the financial interests of the Union whenever the EPPO is not competent or where, although the EPPO is competent, it does not exercise its competence. The Members States which do not participate in enhanced cooperation on the establishment of the EPPO may continue to request Eurojust’s support in all cases regarding offences affecting the financial interests of the Union. The EPPO and Eurojust should develop close operational cooperation in line with their respective mandates. (9) In order for Eurojust to fulfil its mission and develop its full potential in the fight against serious cross-border crime, its operational functions should be strengthened by reducing the administrative workload of national members, and its European dimension enhanced through the Commission’s participation in the Executive Board and the increased involvement of the European Parliament and national parliaments in the evaluation of its activities. (10) Therefore, this Regulation should determine the arrangements for parliamentary involvement, modernising Eurojust’s structure and simplifying its current legal framework, while maintaining those elements that have proven to be efficient in its operation. (11) The forms of serious crime affecting two or more Member States for which Eurojust is competent should be clearly laid down. In addition, cases which do not involve two or more Member States, but which require a prosecution on common bases, should be defined. Such cases may include investigations and prosecutions affecting only one Member State and a third country where an agreement has been concluded with that third country or where there may be a specific need for Eurojust’s involvement. Such prosecution may also refer to cases which affect one Member State and have repercussions at Union level. (12) When exercising its operational functions in relation to concrete criminal cases, at the request of the competent authorities of Member States or on its own initiative, Eurojust should act either through one or more of the national members or as a College. By acting on its own initiative, Eurojust may take a more proactive role in coordinating cases, such as by supporting the national authorities in their investigations and prosecutions. This may include involving Member States that might not initially have been included in the case and discovering links between cases based on the information it receives from Europol, the European Anti-Fraud Office (OLAF), the EPPO and national authorities. This also allows Eurojust to produce guidelines, policy documents and casework-related analyses as part of its strategic work. (13) At the request of a Member State’s competent authority or of the Commission, it should also be possible for Eurojust to assist with investigations involving only that Member State but which have repercussions at Union level. Examples of such investigations include cases where a member of a Union institution or body is involved. Such investigations also cover cases which involve a significant number of Member States and could potentially require a coordinated European response. (14) The written opinions of Eurojust are not binding on Member States, but should be responded to in accordance with this Regulation. (15) To ensure Eurojust can support and coordinate cross-border investigations appropriately, it is necessary that all national members have the necessary operational powers with respect to their Member State and in accordance with the law of that Member State in order to cooperate between themselves and with national authorities in a more coherent and effective way. National members should be granted those powers that allow Eurojust to appropriately achieve its mission. Those powers should include accessing relevant information in national public registers, directly contacting and exchanging information with competent authorities and participating in joint investigation teams. National members may, in accordance with their national law, retain the powers which are derived from their capacity as national authorities. In agreement with the competent national authority or in urgent cases, national members may also order investigative measures and controlled deliveries, and issue and execute requests for mutual legal assistance or mutual recognition. Since those powers are to be exercised in accordance with national law, the courts of Member States should be competent to review those measures, in accordance with the requirements and procedures laid down by national law. (16) It is necessary to provide Eurojust with an administrative and management structure that allows it to perform its tasks more effectively, complies with the principles applicable to Union agencies, and fully respects fundamental rights and freedoms, while maintaining Eurojust’s special characteristics and safeguarding its independence in the exercise of its operational functions. To that end, the functions of the national members, the College and the Administrative Director should be clarified and an Executive Board established. (17) Provisions should be laid down to clearly distinguish between the operational and the management functions of the College, thus reducing the administrative burden on national members to a minimum so that the focus is put on Eurojust’s operational work. The management tasks of the College should include in particular the adoption of Eurojust’s work programmes, budget, annual activity report, and working arrangements with partners. The College should exercise the power of appointing authority with respect to the Administrative Director. The College should also adopt Eurojust’s rules of procedure. Since those rules of procedure may have an impact on the judicial activities of the Member States, implementing powers should be conferred on the Council to approve those rules. (18) To improve Eurojust’s governance and streamline procedures, an Executive Board should be established to assist the College in its management functions and to allow for streamlined decision-making on non-operational and strategic issues. (19) The Commission should be represented in the College when the College exercises its management functions. The Commission’s representative in the College should be also its representative on the Executive Board, to ensure non-operational supervision of Eurojust and to provide it with strategic guidance. (20) In order to ensure the efficient day-to-day administration of Eurojust, the Administrative Director should be its legal representative and manager, accountable to the College. The Administrative Director should prepare and implement the decisions of the College and the Executive Board. The Administrative Director should be appointed on the basis of merit, and of his or her documented administrative and managerial skills, as well as relevant competence and experience. (21) A President and two Vice-Presidents of Eurojust should be elected by the College from among the national members for a term of office of four years. When a national member is elected President, the Member State concerned should be able to second another suitably qualified person to the national desk and to apply for compensation from Eurojust’s budget. (22) Suitably qualified persons are persons who have the necessary qualifications and experience to perform the tasks required to ensure that the national desk functions effectively. They may have the status of a deputy or Assistant to the national member who has been elected President or they may have a more administrative or technical function. Each Member State should be able to decide on its own requirements in this regard. (23) Quorum and voting procedures should be regulated in Eurojust’s rules of procedure. In exceptional cases, where a national member and his or her deputy are absent, the Assistant of the national member concerned should be entitled to vote in the College if the Assistant has the status of a magistrate, i.e. a prosecutor, judge or representative of a judicial authority. (24) Since the compensation mechanism has a budgetary impact, this Regulation should confer implementing powers to determine that mechanism on the Council. (25) The setting up of an on-call coordination mechanism within Eurojust is necessary to make Eurojust more efficient and enable it to be available around the clock to intervene in urgent cases. Each Member State should ensure that their representatives in the on-call coordination mechanism are available to act 24 hours a day, seven days a week. (26) Eurojust national coordination systems should be set up in the Member States to coordinate the work carried out by the national correspondents for Eurojust, the national correspondent for terrorism matters, any national correspondent for issues relating to the competence of the EPPO, the national correspondent for the European Judicial Network and up to three other contact points, as well as representatives in the network for joint investigation teams and representatives in the networks set up by Council Decisions 2002/494/JHA (6), 2007/845/JHA (7) and 2008/852/JHA (8). Member States may decide that one or more of those tasks are to be performed by the same national correspondent. (27) For the purposes of stimulating and strengthening coordination and cooperation between national investigating and prosecuting authorities, it is crucial that Eurojust receive information from national authorities that is necessary for the performance of its tasks. To that end, competent national authorities should inform their national members of the setting up and results of joint investigation teams without undue delay. Competent national authorities should also inform national members without undue delay of cases falling under the competence of Eurojust that directly involve at least three Member States and for which requests or decisions on judicial cooperation have been transmitted to at least two Member States. Under certain circumstances, they should also inform national members of conflicts of jurisdiction, controlled deliveries and repeated difficulties in judicial cooperation. (28) Directive (EU) 2016/680 of the European Parliament and of the Council (9) sets out harmonised rules for the protection and the free movement of personal data processed for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security. In order to ensure the same level of protection for natural persons through legally enforceable rights throughout the Union and to prevent divergences hampering the exchange of personal data between Eurojust and competent authorities in Member States, the rules for the protection and the free movement of operational personal data processed by Eurojust should be consistent with Directive (EU) 2016/680. (29) The general rules of the distinct Chapter of Regulation (EU) 2018/1725 of the European Parliament and of the Council (10) on the processing of operational personal data should apply without prejudice to the specific data protection rules of this Regulation. Such specific rules should be regarded as lex specialis to the provisions in that Chapter of Regulation (EU) 2018/1725 (lex specialis derogat legi generali). In order to reduce legal fragmentation, specific data protection rules in this Regulation should be consistent with the principles underpinning that Chapter of Regulation (EU) 2018/1725, as well as with the provisions of that Regulation relating to independent supervision, remedies, liability and penalties. (30) The protection of the rights and freedoms of data subjects requires a clear attribution of responsibilities for data protection under this Regulation. Member States should be responsible for the accuracy of data they have transmitted to Eurojust and which have been processed unaltered by Eurojust, for keeping such data up to date and for the legality of transmitting those data to Eurojust. Eurojust should be responsible for the accuracy of data provided by other data suppliers or resulting from Eurojust’s own analyses or data collection and for keeping such data up to date. Eurojust should ensure that data are processed fairly and lawfully, and are collected and processed for a specific purpose. Eurojust should also ensure that the data are adequate, relevant, not excessive in relation to the purpose for which they are processed, stored no longer than is necessary for that purpose, and processed in a manner that ensures appropriate security of personal data and confidentiality of data processing. (31) Appropriate safeguards for the storage of operational personal data for archiving purposes in the public interest or statistical purposes should be included in Eurojust’s rules of procedure. (32) A data subject should be able to exercise the right of access referred to in Regulation (EU) 2018/1725 to operational personal data relating to him or her which are processed by Eurojust. The data subject may make such a request at reasonable intervals, free of charge, to Eurojust or to the national supervisory authority in the Member State of the data subject’s choice. (33) The data protection provisions of this Regulation are without prejudice to the applicable rules on the admissibility of personal data as evidence in criminal pre-trial and court proceedings. (34) All processing of personal data by Eurojust, within the framework of its competence, for the fulfilment of its tasks should be considered as processing of operational personal data. (35) As Eurojust also processes administrative personal data unrelated to criminal investigations, the processing of such data should be subject to the general rules of Regulation (EU) 2018/1725. (36) Where operational personal data are transmitted or supplied to Eurojust by the Member State, the competent authority, the national member or the national correspondent for Eurojust should have the right to request rectification or erasure of those operational personal data. (37) In order to demonstrate compliance with this Regulation, Eurojust or the authorised processor should maintain records regarding all categories of processing activities under its responsibility. Eurojust and each authorised processor should be obliged to cooperate with the European Data Protection Supervisor (the ‘EDPS’) and to make those records available to it on request, so that they might serve for monitoring those processing operations. Eurojust or its authorised processor, when processing personal data in non-automated processing systems, should have in place effective methods of demonstrating the lawfulness of the processing, of enabling self-monitoring and of ensuring data integrity and data security, such as logs or other forms of records. (38) The Executive Board of Eurojust should designate a Data Protection Officer who should be a member of the existing staff. The person designated as Data Protection Officer of Eurojust should have received specialised training in data protection law and practice for acquiring expert knowledge in that field. The necessary level of expert knowledge should be determined in relation to the data processing carried out and the protection required for the personal data processed by Eurojust. (39) The EDPS should be responsible for monitoring and ensuring the complete application of the data protection provisions of this Regulation with regard to processing of operational personal data by Eurojust. The EDPS should be granted powers allowing him or her to fulfil this duty effectively. The EDPS should have the right to consult Eurojust regarding submitted requests, to refer matters to Eurojust for the purpose of addressing concerns that have emerged regarding its processing of operational personal data, to make proposals for improving the protection of the data subjects, and to order Eurojust to carry out specific operations with regard to processing of operational personal data. As a result, the EDPS requires the means to have the orders complied with and executed. He or she should therefore also have the power to warn Eurojust. To warn means to issue an oral or written reminder of Eurojust’s obligation to execute the EDPS’ orders or to comply with the proposals of the EDPS and a reminder of the measures to be applied upon any non-compliance or refusal by Eurojust. (40) The duties and powers of the EDPS, including the power to order Eurojust to carry out the rectification, restriction of processing or erasure of operational personal data which have been processed in breach of the data protection provisions contained in this Regulation, should not extend to the personal data contained in national case files. (41) In order to facilitate cooperation between the EDPS and the national supervisory authorities, but without prejudice to the independence of the EDPS or to his or her responsibility for supervision of Eurojust with regard to data protection, the EDPS and national supervisory authorities should regularly meet within the European Data Protection Board, in line with the rules on coordinated supervision laid down in Regulation (EU) 2018/1725. (42) As the first recipient on the territory of the Union of data provided by or retrieved from third countries or international organisations, Eurojust should be responsible for the accuracy of such data. Eurojust should take measures to verify as far as possible the accuracy of the data upon receiving the data or when making data available to other authorities. (43) Eurojust should be subject to the general rules on contractual and non-contractual liability applicable to Union institutions, bodies, offices and agencies. (44) Eurojust should be able to exchange relevant personal data and maintain cooperative relations with other Union institutions, bodies, offices or agencies to the extent necessary for the fulfilment of its or their tasks. (45) To guarantee purpose limitation, it is important to ensure that personal data can be transferred by Eurojust to third countries and international organisations only if necessary for preventing and combating crime that falls within Eurojust’s tasks. To this end, it is necessary to ensure that, when personal data are transferred, the recipient gives an undertaking that the data will be used by the recipient or transferred onward to a competent authority of a third country solely for the purpose for which they were originally transferred. Further onward transfer of the data should take place in compliance with this Regulation. (46) All Member States are affiliated to the International Criminal Police Organisation (Interpol). To fulfil its mission, Interpol receives, stores and circulates personal data to assist competent authorities in preventing and combating international crime. It is therefore appropriate to strengthen cooperation between the Union and Interpol by promoting an efficient exchange of personal data while ensuring respect for fundamental rights and freedoms regarding the automatic processing of personal data. Where operational personal data are transferred from Eurojust to Interpol, and to countries which have delegated members to Interpol, this Regulation, in particular the provisions on international transfers, should apply. This Regulation should be without prejudice to the specific rules laid down in Council Common Position 2005/69/JHA (11) and Council Decision 2007/533/JHA (12). (47) When Eurojust transfers operational personal data to an authority of a third country or to an international organisation by virtue of an international agreement concluded pursuant to Article 218 TFEU, adequate safeguards should be provided for with respect to the protection of privacy and fundamental rights and freedoms of individuals to ensure that the applicable data protection rules are complied with. (48) Eurojust should ensure that a transfer to a third country or to an international organisation takes place only if necessary for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security, and that the controller in the third country or international organisation is an authority competent within the meaning of this Regulation. A transfer should be carried out only by Eurojust acting as controller. Such a transfer may take place in cases where the Commission has decided that the third country or international organisation in question ensures an adequate level of protection, where appropriate safeguards have been provided, or where derogations for specific situations apply. (49) Eurojust should be able to transfer personal data to an authority of a third country or an international organisation on the basis of a Commission decision finding that the country or international organisation in question ensures an adequate level of data protection (‘adequacy decision’), or, in the absence of an adequacy decision, an international agreement concluded by the Union pursuant to Article 218 TFEU, or a cooperation agreement allowing for the exchange of personal data concluded between Eurojust and the third country prior to the date of application of this Regulation. (50) Where the College identifies an operational need for cooperation with a third country or an international organisation, it should be able to suggest that the Council draw the attention of the Commission to the need for an adequacy decision or for a recommendation for the opening of negotiations on an international agreement pursuant to Article 218 TFEU. (51) Transfers not based on an adequacy decision should be allowed only where appropriate safeguards have been provided in a legally binding instrument which ensures the protection of personal data or where Eurojust has assessed all the circumstances surrounding the data transfer and, on the basis of that assessment, considers that appropriate safeguards with regard to the protection of personal data exist. Such legally binding instruments could, for example, be legally binding bilateral agreements which have been concluded by the Member States and implemented in their legal order and which could be enforced by their data subjects, ensuring compliance with data protection requirements and the rights of the data subjects, including the right to obtain effective administrative or judicial redress. Eurojust should be able to take into account cooperation agreements concluded between Eurojust and third countries which allow for the exchange of personal data when carrying out the assessment of all the circumstances surrounding the data transfer. Eurojust should be able to also take into account the fact that the transfer of personal data will be subject to confidentiality obligations and the principle of specificity, ensuring that the data will not be processed for other purposes than for the purposes of the transfer. In addition, Eurojust should take into account that the personal data will not be used to request, hand down or execute a death penalty or any form of cruel and inhuman treatment. While those conditions could be considered to be appropriate safeguards allowing the transfer of data, Eurojust should be able to require additional safeguards. (52) Where no adequacy decision or appropriate safeguards exist, a transfer or a category of transfers could take place only in specific situations, if necessary to protect the vital interests of the data subject or another person, or to safeguard legitimate interests of the data subject where the law of the Member State transferring the personal data so provides; for the prevention of an immediate and serious threat to the public security of a Member State or a third country; in an individual case for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security; or in an individual case for the establishment, exercise or defence of legal claims. Those derogations should be interpreted restrictively and should not allow frequent, massive and structural transfers of personal data, or large-scale transfers of data, but should be limited to data strictly necessary. Such transfers should be documented and should be made available to the EDPS on request in order to monitor the lawfulness of the transfer. (53) In exceptional cases, Eurojust should be able to extend the deadlines for the storage of operational personal data in order to achieve its objectives, subject to observance of the purpose limitation principle applicable to processing of personal data in the context of all its activities. Such decisions should be taken following careful consideration of all interests at stake, including those of the data subjects. Any extension of a deadline for processing personal data in cases where prosecution is time-barred in all Member States concerned should be decided only where there is a specific need to provide assistance under this Regulation. (54) Eurojust should maintain privileged relations with the European Judicial Network based on consultation and complementarity. This Regulation should help clarify the respective roles of Eurojust and the European Judicial Network and their mutual relations, while maintaining the specificity of the European Judicial Network. (55) Eurojust should maintain cooperative relations with other Union institutions, bodies, offices and agencies, with the EPPO, with the competent authorities of third countries and with international organisations, to the extent required for the fulfilment of its tasks. (56) To enhance operational cooperation between Eurojust and Europol, and particularly to establish links between data already in the possession of either agency, Eurojust should enable Europol to have access, on the basis of a hit/no-hit system, to data held by Eurojust. Eurojust and Europol should ensure that the necessary arrangements are established to optimise their operational cooperation, taking due account of their respective mandates and any restrictions provided by the Member States. These working arrangements should ensure access to, and the possibility of searching, all information that has been provided to Europol for the purpose of cross-checking in accordance with the specific safeguards and data protection guarantees provided for in this Regulation. Any access by Europol to data held by Eurojust should be limited by technical means to information falling within the respective mandates of those Union agencies. (57) Eurojust and Europol should keep each other informed of any activity involving the financing of joint investigation teams. (58) Eurojust should be able to exchange personal data with Union institutions, bodies, offices and agencies to the extent necessary for the fulfilment of its tasks, with full respect for the protection of privacy and other fundamental rights and freedoms. (59) Eurojust should enhance its cooperation with competent authorities of third countries and international organisations on the basis of a strategy drawn up in consultation with the Commission. For that purpose, provision should be made for Eurojust to post liaison magistrates to third countries in order to achieve objectives similar to those assigned to liaison magistrates seconded by the Member States on the basis of Council Joint Action 96/277/JHA (13). (60) Provision should be made for Eurojust to coordinate the execution of requests for judicial cooperation issued by a third country, where those requests require execution in at least two Member States as part of the same investigation. Eurojust should only undertake such coordination with the agreement of the Member States concerned. (61) To guarantee the full autonomy and independence of Eurojust, it should be granted an autonomous budget sufficient to properly carry out its work, with revenue coming essentially from a contribution from the budget of the Union, except as regards the salaries and emoluments of the national members, deputies and Assistants, which are borne by their Member State. The Union budgetary procedure should be applicable as far as the Union contribution and other subsidies chargeable to the general budget of the Union are concerned. The auditing of accounts should be undertaken by the Court of Auditors and approved by the Committee on Budgetary Control of the European Parliament. (62) In order to increase the transparency and democratic oversight of Eurojust, it is necessary to provide a mechanism pursuant to Article 85(1) TFEU for the joint evaluation of Eurojust’s activities by the European Parliament and national parliaments. The evaluation should take place in the framework of an inter-parliamentary committee meeting in the premises of the European Parliament in Brussels, with the participation of members of the competent committees of the European Parliament and of the national parliaments. The interparliamentary committee meeting should fully respect Eurojust’s independence as regards actions to be taken in specific operational cases and as regards the obligation of discretion and confidentiality. (63) It is appropriate to evaluate the application of this Regulation regularly. (64) Eurojust’s functioning should be transparent in accordance with Article 15(3) TFEU. Specific provisions on how the right of public access to documents is ensured should be adopted by the College. Nothing in this Regulation is intended to restrict the right of public access to documents in so far as it is guaranteed in the Union and in the Member States, in particular under Article 42 of the Charter of Fundamental Rights of the European Union (the ‘Charter’). The general rules on transparency that apply to Union agencies should also apply to Eurojust in a way that does not jeopardise in any manner the obligation of confidentiality in its operational work. Administrative inquiries conducted by the European Ombudsman should respect the obligation of confidentiality of Eurojust. (65) In order to increase Eurojust’s transparency vis-à-vis Union citizens and its accountability, Eurojust should publish a list of its Executive Board members on its website and, where appropriate, summaries of the outcome of the meetings of the Executive Board, while respecting data protection requirements. (66) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (14) should apply to Eurojust. (67) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (15) should apply to Eurojust. (68) The necessary provisions regarding accommodation for Eurojust in the Member State in which it has its headquarters, that is to say in the Netherlands, and the specific rules applicable to all Eurojust’s staff and members of their families should be laid down in a headquarters agreement. The host Member State should provide the best possible conditions to ensure the functioning of Eurojust, including multilingual, European-oriented schooling and appropriate transport connections, so as to attract high-quality human resources from as wide a geographical area as possible. (69) Eurojust as established by this Regulation should be the legal successor of Eurojust as established by Decision 2002/187/JHA with respect to all its contractual obligations, including employment contracts, liabilities and properties acquired. International agreements concluded by Eurojust as established by that Decision should remain in force. (70) Since the objective of this Regulation, namely the setting up of an entity responsible for supporting and strengthening coordination and cooperation between judicial authorities of the Member States in relation to serious crime affecting two or more Member States or requiring a prosecution on common bases, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (71) In accordance with Articles 1 and 2 and Article 4a(1) of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, and without prejudice to Article 4 of that Protocol, those Member States are not taking part in the adoption of this Regulation and are not bound by it or subject to its application. (72) In accordance with Articles 1 and 2 of the Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application. (73) The EDPS was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council (16) and delivered an opinion on 5 March 2014. (74) This Regulation fully respects the fundamental rights and safeguards and observes the principles recognised in particular by the Charter, HAVE ADOPTED THIS REGULATION: CHAPTER I ESTABLISHMENT, OBJECTIVES AND TASKS OF EUROJUST Article 1 Establishment of the European Union Agency for Criminal Justice Cooperation 1. The European Union Agency for Criminal Justice Cooperation (Eurojust) is hereby established. 2. Eurojust as established by this Regulation shall replace and succeed Eurojust as established by Decision 2002/187/JHA. 3. Eurojust shall have legal personality. Article 2 Tasks 1. Eurojust shall support and strengthen coordination and cooperation between national investigating and prosecuting authorities in relation to serious crime which Eurojust is competent to deal with in accordance with Article 3(1) and (3), where that crime affects two or more Member States, or requires prosecution on common bases, on the basis of operations conducted and information supplied by the Member States’ authorities, by Europol, by the EPPO and by OLAF. 2. In carrying out its tasks, Eurojust shall: (a) take into account any request emanating from a competent authority of a Member State, any information provided by Union authorities, institutions, bodies, offices and agencies competent by virtue of provisions adopted within the framework of the Treaties and any information collected by Eurojust itself; (b) facilitate the execution of requests for, and decisions on, judicial cooperation, including requests and decisions based on instruments that give effect to the principle of mutual recognition. 3. Eurojust shall carry out its tasks at the request of the competent authorities of the Member States, on its own initiative or at the request of the EPPO within the limits of the EPPO’s competence. Article 3 Competence of Eurojust 1. Eurojust shall be competent with respect to the forms of serious crime listed in Annex I. However, as of the date on which the EPPO assumes its investigative and prosecutorial tasks in accordance with Article 120(2) of Regulation (EU) 2017/1939, Eurojust shall not exercise its competence with regard to crimes for which the EPPO exercises its competence, except in those cases where Member States which do not participate in enhanced cooperation on the establishment of the EPPO are also involved and at the request of those Member States or at the request of the EPPO. 2. Eurojust shall exercise its competence for crimes affecting the financial interests of the Union in cases involving Member States which participate in enhanced cooperation on the establishment of the EPPO but in respect of which the EPPO does not have competence or decides not to exercise its competence. Eurojust, the EPPO and the Member States concerned shall consult and cooperate with each other to facilitate Eurojust’s exercise of competence under this paragraph. The practical details of its exercise of competence under this paragraph shall be governed by a working arrangement as referred to in Article 47(3). 3. As regards forms of crime other than those listed in Annex I, Eurojust may also, in accordance with its tasks, assist with investigations and prosecutions where requested by a competent authority of a Member State. 4. Eurojust’s competence shall cover criminal offences related to the criminal offences listed in Annex I. The following categories of offences shall be regarded as related criminal offences: (a) criminal offences committed in order to procure the means of committing the serious crimes listed in Annex I; (b) criminal offences committed in order to facilitate or commit the serious crimes listed in Annex I; (c) criminal offences committed in order to ensure the impunity of those committing the serious crimes listed in Annex I. 5. At the request of a Member State’s competent authority, Eurojust may also assist with investigations and prosecutions that only affect that Member State and a third country, provided that a cooperation agreement or arrangement establishing cooperation pursuant to Article 52 has been concluded with that third country or provided that in a specific case there is an essential interest in providing such assistance. 6. At the request of either the competent authority of a Member State or the Commission, Eurojust may assist in investigations and prosecutions that only affect that Member State but which have repercussions at Union level. Before acting at the request of the Commission, Eurojust shall consult the competent authority of the Member State concerned. That competent authority may, within a deadline set by Eurojust, oppose the execution of the request by Eurojust, justifying its position in every case. Article 4 Operational functions of Eurojust 1. Eurojust shall: (a) inform the competent authorities of the Member States of investigations and prosecutions of which it has been informed which have repercussions at Union level or which might affect Member States other than those directly concerned; (b) assist the competent authorities of the Member States in ensuring the best possible coordination of investigations and prosecutions; (c) assist in improving cooperation between the competent authorities of the Member States, in particular on the basis of Europol’s analyses; (d) cooperate and consult with the European Judicial Network in criminal matters, including by making use of and contributing to the improvement of the documentary database of the European Judicial Network; (e) cooperate closely with the EPPO on matters relating to its competence; (f) provide operational, technical and financial support to Member States’ cross-border operations and investigations, including to joint investigation teams; (g) support, and where appropriate participate in, the Union centres of specialised expertise developed by Europol and other Union institutions, bodies, offices and agencies; (h) cooperate with Union institutions, bodies, offices and agencies, as well as networks established in the area of freedom, security and justice regulated under Title V of the TFEU; (i) support Member States’ action in combating forms of serious crime listed in Annex I. 2. In carrying out its tasks, Eurojust may ask the competent authorities of the Member States concerned, giving its reasons, to: (a) undertake an investigation or prosecution of specific acts; (b) accept that one of them may be in a better position to undertake an investigation or to prosecute specific acts; (c) coordinate between the competent authorities of the Member States concerned; (d) set up a joint investigation team in accordance with the relevant cooperation instruments; (e) provide it with any information that is necessary for carrying out its tasks; (f) take special investigative measures; (g) take any other measure justified for the investigation or prosecution. 3. Eurojust may also: (a) provide Europol with opinions based on analyses carried out by Europol; (b) supply logistical support, including translation, interpretation and the organisation of coordination meetings. 4. Where two or more Member States cannot agree as to which of them should undertake an investigation or prosecution following a request under points (a) or (b) of paragraph 2, Eurojust shall issue a written opinion on the case. Eurojust shall send the opinion to the Member States concerned immediately. 5. At the request of a competent authority, or on its own initiative, Eurojust shall issue a written opinion on recurrent refusals or difficulties concerning the execution of requests for, and decisions on, judicial cooperation, including requests and decisions based on instruments giving effect to the principle of mutual recognition, provided that it is not possible to resolve such cases through mutual agreement between the competent national authorities or through the involvement of the national members concerned. Eurojust shall send the opinion to the Member States concerned immediately. 6. The competent authorities of the Member States concerned shall respond to requests from Eurojust under paragraph 2 and to the written opinions referred to in paragraph 4 or 5 without undue delay. The competent authorities of the Member States may refuse to comply with such requests or to follow the written opinion if doing so would harm essential national security interests, would jeopardise the success of an ongoing investigation or would jeopardise the safety of an individual. Article 5 Exercise of operational and other functions 1. Eurojust shall act through one or more of the national members concerned when taking any of the actions referred to in Article 4(1) or (2). Without prejudice to paragraph 2 of this Article, the College shall focus on operational issues and any other issues that are directly linked to operational matters. The College shall only be involved in administrative matters to the extent necessary to ensure that its operational functions are fulfilled. 2. Eurojust shall act as a College: (a) when taking any of the actions referred to in Article 4(1) or (2): (i) at the request of one or more of the national members concerned by a case dealt with by Eurojust; (ii) where the case involves investigations or prosecutions which have repercussions at Union level or which might affect Member States other than those directly concerned; (b) when taking any of the actions referred to in Article 4(3), (4) or (5); (c) where a general question relating to the achievement of its operational objectives is involved; (d) when adopting Eurojust’s annual budget, in which case the decision shall be taken by a majority of two thirds of its members; (e) when adopting the programming document referred to in Article 15 or the annual report on Eurojust’s activities, in which cases the decision shall be taken by a majority of two thirds of its members; (f) when electing or dismissing the President and Vice-Presidents under Article 11; (g) when appointing the Administrative Director or, where relevant, extending his or her term of office or removing him or her from office under Article 17; (h) when adopting working arrangements under Articles 47(3) and 52; (i) when adopting rules for the prevention and management of conflicts of interest in respect of its members, including in relation to their declaration of interests; (j) when adopting reports, policy papers, guidelines for the benefit of national authorities and opinions pertaining to the operational work of Eurojust, whenever those documents are of a strategic nature; (k) when appointing liaison magistrates in accordance with Article 53; (l) when taking any decision which is not expressly attributed to the Executive Board by this Regulation or which is not under the responsibility of the Administrative Director in accordance with Article 18; (m) when otherwise provided for in this Regulation. 3. When it fulfils its tasks, Eurojust shall indicate whether it is acting through one or more of the national members or as a College. 4. The College may assign additional administrative tasks to the Administrative Director and the Executive Board beyond those provided for in Articles 16 and 18, in accordance with its operational needs. Where exceptional circumstances so require, the College may decide to suspend temporarily the delegation of the appointing authority powers to the Administrative Director and of those powers that have been sub-delegated by the latter, and to exercise them itself or to delegate them to one of its members or to a staff member other than the Administrative Director. 5. The College shall adopt Eurojust’s rules of procedure on the basis of a two-thirds majority of its members. In the event that agreement cannot be reached by a two-thirds majority, the decision shall be taken by simple majority. Eurojust’s rules of procedure shall be approved by the Council by means of implementing acts. CHAPTER II STRUCTURE AND ORGANISATION OF EUROJUST SECTION I Structure Article 6 Structure of Eurojust Eurojust shall comprise: (a) the national members; (b) the College; (c) the Executive Board; (d) the Administrative Director. SECTION II National members Article 7 Status of national members 1. Eurojust shall have one national member seconded by each Member State in accordance with its legal system. That national member shall have his or her regular place of work at the seat of Eurojust. 2. Each national member shall be assisted by one deputy and by one Assistant. In principle, the deputy and the Assistant shall have their regular place of work at the seat of Eurojust. Each Member State may decide that the deputy or Assistant or both will have their regular place of work in their Member State. If a Member State takes such a decision, it shall notify the College. If the operational needs of Eurojust so require, the College may request the Member State to assign the deputy or Assistant or both to work at the seat of Eurojust for a specified period. The Member State shall comply with such a request from the College without undue delay. 3. Additional deputies or Assistants may assist the national member and, if necessary and with the agreement of the College, may have their regular place of work at Eurojust. Member States shall notify Eurojust and the Commission of the appointment of national members, deputies and Assistants. 4. National members and deputies shall have the status of a prosecutor, a judge or a representative of a judicial authority with competences equivalent to those of a prosecutor or judge under their national law. The Member States shall grant them at least the powers referred to in this Regulation in order to be able to fulfil their tasks. 5. The terms of office of the national members and their deputies shall be five years, renewable once. In cases where a deputy is unable to act on behalf of a national member or is unable to substitute for a national member, the national member shall remain in office upon expiry of his or her term of office until the renewal of his or her term or his or her replacement, subject to the consent of their Member State. 6. Member States shall appoint national members and deputies on the basis of a proven high level of relevant, practical experience in the field of criminal justice. 7. The deputy shall be able to act on behalf of or to substitute for the national member. An Assistant may also act on behalf of or substitute for the national member if he or she has a status referred to in paragraph 4. 8. Operational information exchange between Eurojust and Member States shall take place through the national members. 9. The salaries and emoluments of the national members, deputies and Assistants shall be borne by their Member State without prejudice to Article 12. 10. Where national members, deputies and Assistants act within the framework of Eurojust’s tasks, the relevant expenditure related to those activities shall be regarded as operational expenditure. Article 8 Powers of national members 1. The national members shall have the power to: (a) facilitate or otherwise support the issuing or execution of any request for mutual legal assistance or mutual recognition; (b) directly contact and exchange information with any competent national authority of the Member State or any other competent Union body, office or agency, including the EPPO; (c) directly contact and exchange information with any competent international authority, in accordance with the international commitments of their Member State; (d) participate in joint investigation teams including in setting them up. 2. Without prejudice to paragraph 1, Member States may grant additional powers to national members in accordance with their national law. Those Member States shall notify the Commission and the College of these powers. 3. With the agreement of the competent national authority, national members may, in accordance with their national law: (a) issue or execute any request for mutual legal assistance or mutual recognition; (b) order, request or execute investigative measures, as provided for in Directive 2014/41/EU of the European Parliament and of the Council (17). 4. In urgent cases where it is not possible to identify or to contact the competent national authority in a timely manner, national members shall be competent to take the measures referred to in paragraph 3 in accordance with their national law, provided that they inform the competent national authority as soon as possible. 5. The national member may submit a proposal to the competent national authority to carry out the measures referred to in paragraphs 3 and 4 where the exercise of the powers referred to in paragraphs 3 and 4 by that national member would be in conflict with: (a) a Member State’s constitutional rules; or (b) fundamental aspects of that Member State’s national criminal justice system regarding: (i) the division of powers between the police, prosecutors and judges; (ii) the functional division of tasks between prosecution authorities; or (iii) the federal structure of the Member State concerned. 6. Member States shall ensure that, in cases referred to in paragraph 5, the proposal submitted by their national member is handled without undue delay by the competent national authority. Article 9 Access to national registers National members shall have access to, or at least be able to obtain the information contained in, the following types of registers of their Member State, in accordance with their national law: (a) criminal records; (b) registers of arrested persons; (c) investigation registers; (d) DNA registers; (e) other registers of public authorities of their Member State where such information is necessary to fulfil their tasks. SECTION III The College Article 10 Composition of the College 1. The College shall be composed of: (a) all the national members; and (b) one representative of the Commission when the College exercises its management functions. The representative of the Commission nominated under point (b) of the first subparagraph should be the same person as the Commission’s representative on the Executive Board under Article 16(4). 2. The Administrative Director shall attend the management meetings of the College, without the right to vote. 3. The College may invite any person whose opinion may be of interest to attend its meetings as an observer. 4. The members of the College may, subject to the provisions of Eurojust’s rules of procedure, be assisted by advisers or experts. Article 11 The President and Vice-President of Eurojust 1. The College shall elect a President and two Vice-Presidents from among the national members by a two-thirds majority of its members. In the event that a two-thirds majority cannot be reached after the second round of election, the Vice-Presidents shall be elected by a simple majority of the members of the College, while a two-thirds majority shall continue to be necessary for the election of the President. 2. The President shall exercise his or her functions on behalf of the College. The President shall: (a) represent Eurojust; (b) call and preside over the meetings of the College and the Executive Board and keep the College informed of any matters that are of interest to it; (c) direct the work of the College and monitor Eurojust’s daily management by the Administrative Director; (d) exercise any other functions set out in Eurojust’s rules of procedure. 3. The Vice-Presidents shall exercise the functions set out in paragraph 2 which the President entrusts to them. They shall replace the President if he or she is prevented from attending to his or her duties. The President and Vice-Presidents shall be assisted in the performance of their specific duties by the administrative staff of Eurojust. 4. The term of office of the President and the Vice-Presidents shall be four years. They may be re-elected once. 5. When a national member is elected President or Vice-President of Eurojust, his or her term of office shall be extended to ensure that he or she can fulfil his or her function as President or Vice-President. 6. If the President or Vice-President no longer fulfils the conditions required for the performance of his or her duties, he or she may be dismissed by the College acting on a proposal from one third of its members. The decision shall be adopted on the basis of a two-thirds majority of the members of the College, excluding the President or Vice-President concerned. 7. When a national member is elected President of Eurojust, the Member State concerned may second another suitably qualified person to reinforce the national desk for the duration of the former’s mandate as President. A Member State which decides to second such a person shall be entitled to apply for compensation in accordance with Article 12. Article 12 Compensation mechanism for the election to the position of President 1. By 12 December 2019, the Council shall, acting on a proposal by the Commission and by means of implementing acts, determine a mechanism for compensation, for the purpose of Article 11(7), to be made available to Member States whose national member is elected President. 2. The compensation shall be available to any Member State if: (a) its national member has been elected President; and (b) it requests compensation from the College and provides justification for the need to reinforce its national desk on grounds of an increased workload. 3. The compensation provided shall equate to 50 % of the national salary of the seconded person. Compensation for living costs and other associated expenses shall be provided on a comparable basis to that provided to Union officials or other servants seconded abroad. 4. The costs of the compensation mechanism shall be borne by Eurojust’s budget. Article 13 Meetings of the College 1. The President shall convene the meetings of the College. 2. The College shall hold at least one meeting per month. In addition, it shall meet on the initiative of the President, at the request of the Commission to discuss the administrative tasks of the College, or at the request of at least one third of its members. 3. Eurojust shall send the EPPO the agenda of College meetings whenever issues are discussed which are of relevance for the exercise of the tasks of the EPPO. Eurojust shall invite the EPPO to participate in such meetings, without the right to vote. When the EPPO is invited to a College meeting, Eurojust shall provide it with the relevant documents supporting the agenda. Article 14 Voting rules of the College 1. Unless stated otherwise, and where a consensus cannot be reached, the College shall take its decisions by a majority of its members. 2. Each member shall have one vote. In the absence of a voting member, the deputy shall be entitled to exercise the right to vote subject to the conditions set out in Article 7(7). In the absence of the deputy, the Assistant shall also be entitled to exercise the right to vote subject to the conditions set out in Article 7(7). Article 15 Annual and multi-annual programming 1. By 30 November each year, the College shall adopt a programming document containing annual and multi-annual programming, based on a draft prepared by the Administrative Director, taking into account the opinion of the Commission. The College shall forward the programming document to the European Parliament, the Council, the Commission and the EPPO. The programming document shall become definitive after final adoption of the general budget of the Union and shall be adjusted accordingly, if necessary. 2. The annual work programme shall comprise detailed objectives and expected results including performance indicators. It shall also contain a description of the actions to be financed and an indication of the financial and human resources allocated to each action, in accordance with the principles of activity-based budgeting and management. The annual work programme shall be coherent with the multi-annual work programme referred to in paragraph 4. It shall clearly indicate which tasks have been added, changed or deleted in comparison with the previous financial year. 3. The College shall amend the adopted annual work programme when a new task is given to Eurojust. Any substantial amendment to the annual work programme shall be adopted by the same procedure as the initial annual work programme. The College may delegate to the Administrative Director the power to make non-substantial amendments to the annual work programme. 4. The multi-annual work programme shall set out overall strategic programming including objectives, the strategy for cooperation with the authorities of third countries and international organisations referred to in Article 52, expected results and performance indicators. It shall also set out resource programming including multi-annual budget and staff. The resource programming shall be updated annually. The strategic programming shall be updated where appropriate, and in particular to address the outcome of the evaluation referred to in Article 69. SECTION IV The executive board Article 16 Functioning of the Executive Board 1. The College shall be assisted by an Executive Board. The Executive Board shall be responsible for taking administrative decisions to ensure the proper functioning of Eurojust. It shall oversee the necessary preparatory work of the Administrative Director on other administrative matters for adoption by the College. It shall not be involved in the operational functions of Eurojust referred to in Articles 4 and 5. 2. The Executive Board may consult the College when carrying out its tasks. 3. The Executive Board shall also: (a) review Eurojust’s programming document referred to in Article 15 based on the draft prepared by the Administrative Director and forward it to the College for adoption; (b) adopt an anti-fraud strategy for Eurojust, proportionate to the fraud risks, taking into account the costs and benefits of the measures to be implemented and based on a draft prepared by the Administrative Director; (c) adopt appropriate implementing rules giving effect to the Staff Regulations of Officials of the European Union (the ‘Staff Regulations of Officials’) and the Conditions of Employment of Other Servants of the European Union (‘Conditions of Employment of Other Servants’), laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (18) in accordance with Article 110 of the Staff Regulations of Officials; (d) ensure adequate follow-up to the findings and recommendations stemming from the internal or external audit reports, evaluations and investigations, including those of the EDPS and OLAF; (e) take all decisions on the establishment and, where necessary, the modification of Eurojust’s internal administrative structures; (f) without prejudice to the responsibilities of the Administrative Director set out in Article 18, assist and advise him or her on the implementation of the decisions of the College, with a view to reinforcing supervision of administrative and budgetary management; (g) undertake any additional administrative tasks assigned to it by the College under Article 5(4); (h) adopt the financial rules applicable to Eurojust in accordance with Article 64; (i) adopt, in accordance with Article 110 of the Staff Regulations of Officials, a decision based on Article 2(1) of the Staff Regulations of Officials and on Article 6 of the Conditions of Employment of Other Servants delegating the relevant appointing authority powers to the Administrative Director and establishing the conditions under which this delegation of powers can be suspended; the Administrative Director shall be authorised to sub-delegate those powers; (j) review Eurojust’s draft annual budget for adoption by the College; (k) review the draft annual report on Eurojust’s activities and forward it to the College for adoption; (l) appoint an accounting officer and a Data Protection Officer who are functionally independent in the performance of their duties. 4. The Executive Board shall be composed of the President and Vice-Presidents of Eurojust, one representative of the Commission and two other members of the College designated on a two-year rotation system in accordance with Eurojust’s rules of procedure. The Administrative Director shall attend the meetings of the Executive Board without the right to vote. 5. The President of Eurojust shall be the chairperson of the Executive Board. The Executive Board shall take its decisions by a majority of its members. Each member shall have one vote. In the event of a tied vote, the President of Eurojust shall have a casting vote. 6. The term of office of members of the Executive Board shall end when their term as national members, President or Vice-President ends. 7. The Executive Board shall meet at least once a month. In addition, it shall meet on the initiative of its chairperson or at the request of the Commission or of at least two of its other members. 8. Eurojust shall send to the EPPO the agenda of the Executive Board meetings and consult with the EPPO on the need to participate in those meetings. Eurojust shall invite the EPPO to participate, without the right to vote, whenever issues are discussed which are of relevance for the functioning of the EPPO. When the EPPO is invited to an Executive Board meeting, Eurojust shall provide it with the relevant documents supporting the agenda. SECTION V The Administrative Director Article 17 Status of the Administrative Director 1. The Administrative Director shall be engaged as a temporary agent of Eurojust under point (a) of Article 2 of the Conditions of Employment of Other Servants. 2. The Administrative Director shall be appointed by the College from a list of candidates proposed by the Executive Board, following an open and transparent selection procedure in accordance with Eurojust’s rules of procedure. For the purpose of concluding the employment contract with the Administrative Director, Eurojust shall be represented by the President of Eurojust. 3. The term of office of the Administrative Director shall be four years. By the end of that period, the Executive Board shall undertake an assessment that takes into account an evaluation of the performance of the Administrative Director. 4. The College, acting on a proposal from the Executive Board that takes into account the assessment referred to in paragraph 3, may extend the term of office of the Administrative Director once and for no more than four years. 5. An Administrative Director whose term of office has been extended shall not participate in another selection procedure for the same post at the end of the overall period. 6. The Administrative Director shall be accountable to the College. 7. The Administrative Director may be removed from the office only pursuant to a decision of the College acting on a proposal from the Executive Board. Article 18 Responsibilities of the Administrative Director 1. For administrative purposes, Eurojust shall be managed by its Administrative Director. 2. Without prejudice to the powers of the College or the Executive Board, the Administrative Director shall be independent in the performance of his or her duties and shall neither seek nor take instructions from any government or any other body. 3. The Administrative Director shall be the legal representative of Eurojust. 4. The Administrative Director shall be responsible for the implementation of the administrative tasks assigned to Eurojust, in particular: (a) the day-to-day administration of Eurojust and staff management; (b) implementing the decisions adopted by the College and the Executive Board; (c) preparing the programming document referred to in Article 15 and submitting it to the Executive Board for review; (d) implementing the programming document referred to in Article 15 and reporting to the Executive Board and College on its implementation; (e) preparing the annual report on Eurojust’s activities and presenting it to the Executive Board for review and to the College for adoption; (f) preparing an action plan following up on conclusions of internal or external audit reports, evaluations and investigations, including those of the EDPS and OLAF and reporting on progress twice a year to the College, to the Executive Board, to the Commission and to the EDPS; (g) preparing an anti-fraud strategy for Eurojust and presenting it to the Executive Board for adoption; (h) preparing draft financial rules applicable to Eurojust; (i) preparing Eurojust’s draft statement of estimates of revenue and expenditure and implementing its budget; (j) exercising, with respect to the staff of Eurojust, the powers conferred by the Staff Regulations of Officials on the appointing authority and by the Conditions of Employment of Other Servants on the authority empowered to conclude contracts of employment of other servants (‘the appointing authority powers’); (k) ensuring that the necessary administrative support is provided to facilitate the operational work of Eurojust; (l) ensuring that support is provided to the President and Vice-Presidents as they carry out their duties; (m) preparing a draft proposal for Eurojust’s annual budget, which shall be reviewed by the Executive Board before adoption by the College. CHAPTER III OPERATIONAL MATTERS Article 19 On-call coordination mechanism 1. In order to fulfil its tasks in urgent cases, Eurojust shall operate an on-call coordination mechanism (‘OCC’) able to receive and process at all times the requests referred to it. The OCC shall be contactable 24 hours a day, seven days a week. 2. The OCC shall rely on one OCC representative per Member State who may be either the national member, his or her deputy, an Assistant entitled to replace the national member, or a seconded national expert. The OCC representative shall be available to act 24 hours a day, seven days a week. 3. The OCC representatives shall act efficiently and without delay in relation to the execution of a request in their Member State. Article 20 Eurojust national coordination system 1. Each Member State shall appoint one or more national correspondents for Eurojust. 2. All national correspondents appointed by the Member States under paragraph 1 shall have the skills and experience necessary for them to carry out their duties. 3. Each Member State shall set up a Eurojust national coordination system to ensure coordination of the work carried out by: (a) the national correspondents for Eurojust; (b) any national correspondents for issues relating to the competence of the EPPO; (c) the national correspondent for Eurojust for terrorism matters; (d) the national correspondent for the European Judicial Network in criminal matters and up to three other contact points of the European Judicial Network; (e) national members or contact points of the Network for joint investigation teams, and national members or contact points of the networks set up by Decisions 2002/494/JHA, 2007/845/JHA and 2008/852/JHA; (f) where applicable, any other relevant judicial authority. 4. The persons referred to in paragraphs 1 and 3 shall retain their position and status under national law, without this having a significant impact on the performance of their duties under this Regulation. 5. The national correspondents for Eurojust shall be responsible for the functioning of their Eurojust national coordination system. Where several correspondents for Eurojust are appointed, one of them shall be responsible for the functioning of their Eurojust national coordination system. 6. The national members shall be informed of all meetings of their Eurojust national coordination system where casework-related matters are discussed. The national members may attend such meetings as necessary. 7. Each Eurojust national coordination system shall facilitate the carrying out of Eurojust’s tasks within the Member State concerned, in particular by: (a) ensuring that the case management system referred to in Article 23 receives information related to the Member State concerned in an efficient and reliable manner; (b) assisting in determining whether a request should be handled with the assistance of Eurojust or of the European Judicial Network; (c) assisting the national member in identifying relevant authorities for the execution of requests for, and decisions on, judicial cooperation, including requests and decisions based on instruments giving effect to the principle of mutual recognition; (d) maintaining close relations with the Europol national unit, other contact points of the European Judicial Network and other relevant competent national authorities. 8. In order to meet the objectives referred to in paragraph 7, the persons referred to in paragraph 1 and in points (a), (b) and (c) of paragraph 3 shall, and the persons or authorities referred to in points (d) and (e) of paragraph 3 may be connected to the case management system in accordance with this Article and with Articles 23, 24, 25 and 34. The cost of connection to the case management system shall be borne by the general budget of the Union. 9. The setting up of the Eurojust national coordination system and the appointment of national correspondents shall not prevent direct contacts between the national member and the competent authorities of his or her Member State. Article 21 Exchanges of information with the Member States and between national members 1. The competent authorities of the Member States shall exchange with Eurojust all information necessary for the performance of its tasks under Articles 2 and 4 in accordance with the applicable data protection rules. This shall at least include the information referred to in paragraphs 4, 5 and 6 of this Article. 2. The transmission of information to Eurojust shall only be interpreted as a request for the assistance of Eurojust in the case concerned if so specified by a competent authority. 3. The national members shall exchange all information necessary for the performance of Eurojust’s tasks among themselves or with their competent national authorities, without prior authorisation. In particular, the competent national authorities shall promptly inform their national members of a case which concerns them. 4. The competent national authorities shall inform their national members of the setting up of joint investigation teams and of the results of the work of such teams. 5. The competent national authorities shall inform their national members without undue delay of any case affecting at least three Member States for which requests for or decisions on judicial cooperation, including requests and decisions based on instruments giving effect to the principle of mutual recognition, have been transmitted to at least two Member States, where one or more of the following apply: (a) the offence involved is punishable in the requesting or issuing Member State by a custodial sentence or a detention order, the maximum period of which is at least five or six years, to be decided by the Member State concerned, and is included in the following list: (i) trafficking in human beings; (ii) sexual abuse or sexual exploitation including child pornography and solicitation of children for sexual purposes; (iii) drug trafficking; (iv) illicit trafficking in firearms, their parts or components or ammunition or explosives; (v) corruption; (vi) crime against the financial interests of the Union; (vii) forgery of money or means of payment; (viii) money laundering activities; (ix) computer crime; (b) there are factual indications that a criminal organisation is involved; (c) there are indications that the case may have a serious cross-border dimension or may have repercussions at Union level, or that it may affect Member States other than those directly involved. 6. The competent national authorities shall inform their national members of: (a) cases in which conflicts of jurisdiction have arisen or are likely to arise; (b) controlled deliveries affecting at least three countries, at least two of which are Member States; (c) repeated difficulties or refusals regarding the execution of requests for, or decisions on, judicial cooperation, including requests and decisions based on instruments giving effect to the principle of mutual recognition. 7. The competent national authorities shall not be obliged to supply information in a particular case if doing so would harm essential national security interests or jeopardise the safety of individuals. 8. This Article is without prejudice to conditions set out in bilateral or multilateral agreements or arrangements between Member States and third countries, including any conditions set by third countries concerning the use of information once supplied. 9. This Article is without prejudice to other obligations regarding the transmission of information to Eurojust, including Council Decision 2005/671/JHA (19). 10. Information referred to in this Article shall be provided in a structured way determined by Eurojust. The competent national authority shall not be obliged to provide such information where it has already been transmitted to Eurojust in accordance with other provisions of this Regulation. Article 22 Information provided by Eurojust to competent national authorities 1. Eurojust shall provide competent national authorities with information on the results of the processing of information, including the existence of links with cases already stored in the case management system, without undue delay. That information may include personal data. 2. Where a competent national authority requests that Eurojust provide it with information within a certain timeframe, Eurojust shall transmit that information within that timeframe. Article 23 Case management system, index and temporary work files 1. Eurojust shall establish a case management system composed of temporary work files and of an index which contain the personal data referred to in Annex II and non-personal data. 2. The purpose of the case management system shall be to: (a) support the management and coordination of investigations and prosecutions for which Eurojust is providing assistance, in particular by cross-referencing information; (b) facilitate access to information on on-going investigations and prosecutions; (c) facilitate the monitoring of the lawfulness of Eurojust’s processing of personal data and its compliance with the applicable data protection rules. 3. The case management system may be linked to the secure telecommunications connection referred to in Article 9 of Council Decision 2008/976/JHA (20). 4. The index shall contain references to temporary work files processed within the framework of Eurojust and may not contain any personal data other than those referred to in points (1)(a) to (i), (k) and (m) and (2) of Annex II. 5. In the performance of their duties, national members may process data on the individual cases on which they are working in a temporary work file. They shall allow the Data Protection Officer to have access to the temporary work file. The Data Protection Officer shall be informed by the national member concerned of the opening of each new temporary work file that contains personal data. 6. For the processing of operational personal data, Eurojust may not establish any automated data file other than the case management system. The national member may, however, temporarily store and analyse personal data for the purpose of determining whether such data are relevant to Eurojust’s tasks and can be included in the case management system. That data may be held for up to three months. Article 24 Functioning of temporary work files and the index 1. A temporary work file shall be opened by the national member concerned for every case with respect to which information is transmitted to him or her in so far as that transmission is in accordance with this Regulation or other applicable legal instruments. The national member shall be responsible for the management of the temporary work files opened by that national member. 2. The national member who has opened a temporary work file shall decide, on a case-by-case basis, whether to keep the temporary work file restricted or to give access to it or to parts of it to other national members, to authorised Eurojust staff or to any other person working on behalf of Eurojust who has received the necessary authorisation from the Administrative Director. 3. The national member who has opened a temporary work file shall decide which information related to that temporary work file shall be introduced in the index in accordance with Article 23(4). Article 25 Access to the case management system at national level 1. In so far as they are connected to the case management system, persons referred to in Article 20(3) shall only have access to: (a) the index, unless the national member who has decided to introduce the data in the index expressly denied such access; (b) temporary work files opened by the national member of their Member State; (c) temporary work files opened by national members of other Member States and to which the national member of their Member States has received access, unless the national member who opened the temporary work file expressly denied such access. 2. The national member shall, within the limitations provided for in paragraph 1 of this Article, decide on the extent of access to the temporary work files which is granted in his or her Member State to the persons referred to in Article 20(3) in so far as they are connected to the case management system. 3. Each Member State shall decide, after consultation with its national member, on the extent of access to the index which is granted in that Member State to the persons referred to in Article 20(3) in so far as they are connected to the case management system. Member States shall notify Eurojust and the Commission of their decision regarding the implementation of this paragraph. The Commission shall inform the other Member States thereof. 4. Persons who have been granted access in accordance with paragraph 2 shall at least have access to the index to the extent necessary to access the temporary work files to which they have been granted access. CHAPTER IV PROCESSING OF INFORMATION Article 26 Processing of personal data by Eurojust 1. This Regulation and Article 3 and Chapter IX of Regulation (EU) 2018/1725 shall apply to the processing of operational personal data by Eurojust. Regulation (EU) 2018/1725 shall apply to the processing of administrative personal data by Eurojust, with the exception of Chapter IX of that Regulation. 2. References to ‘applicable data protection rules’ in this Regulation shall be understood as references to the provisions on data protection set out in this Regulation and in Regulation (EU) 2018/1725. 3. The data protection rules on processing of operational personal data contained in this Regulation shall be considered as specific data protection rules to the general rules laid down in Article 3 and Chapter IX of Regulation (EU) 2018/1725. 4. Eurojust shall determine the time limits for the storage of administrative personal data in the data protection provisions of its rules of procedure. Article 27 Processing of operational personal data 1. In so far as it is necessary to perform its tasks, Eurojust may, within the framework of its competence and in order to carry out its operational functions, process by automated means or in structured manual files in accordance with this Regulation only the operational personal data listed in point 1 of Annex II of persons who, under the national law of the Member States concerned, are persons with regard to whom there are serious grounds for believing that they have committed or are about to commit a criminal offence in respect of which Eurojust is competent or who have been convicted of such an offence. 2. Eurojust may process only the operational personal data listed in point 2 of Annex II of persons who, under the national law of the Member States concerned, are regarded as victims or other parties to a criminal offence, such as persons who might be called to testify in a criminal investigation or prosecution regarding one or more of the types of crime and the criminal offences referred to in Article 3, persons who are able to provide information on criminal offences, or contacts or associates of a person referred to in paragraph 1. The processing of such operational personal data may only take place if it is necessary for the fulfilment of the tasks of Eurojust, within the framework of its competence and in order to carry out its operational functions. 3. In exceptional cases, for a limited period of time which shall not exceed the time needed for the conclusion of the case in relation to which the data are processed, Eurojust may also process operational personal data other than the personal data referred to in Annex II relating to the circumstances of an offence, where such data are immediately relevant to and are included in ongoing investigations which Eurojust is coordinating or helping to coordinate and when their processing is necessary for the purposes specified in paragraph 1. The Data Protection Officer referred to in Article 36 shall be informed immediately when such operational personal data are processed, and shall be informed of the specific circumstances which justify the necessity of the processing of those operational personal data. Where such other data refer to witnesses or victims within the meaning of paragraph 2 of this Article, the decision to process them shall be taken jointly by the national members concerned. 4. Eurojust may process special categories of operational personal data in accordance with Article 76 of Regulation (EU) 2018/1725. Such data may not be processed in the index referred to in Article 23(4) of this Regulation. Where such other data refer to witnesses or victims within the meaning of paragraph 2 of this Article, the decision to process them shall be taken by the national members concerned. Article 28 Processing under the authority of Eurojust or processor The processor and any person acting under the authority of Eurojust or of the processor who has access to operational personal data shall not process those data except on instructions from Eurojust, unless required to do so by Union law or Member State law. Article 29 Time limits for the storage of operational personal data 1. Operational personal data processed by Eurojust shall be stored by Eurojust for only as long as is necessary for the performance of its tasks. In particular, without prejudice to paragraph 3 of this Article, the operational personal data referred to in Article 27 may not be stored beyond the first applicable date among the following dates: (a) the date on which prosecution is barred under the statute of limitations of all the Member States concerned by the investigation and prosecutions; (b) the date on which Eurojust is informed that the person has been acquitted and the judicial decision became final, in which case the Member State concerned shall inform Eurojust without delay; (c) three years after the date on which the judicial decision of the last of the Member States concerned by the investigation or prosecution became final; (d) the date on which Eurojust and the Member States concerned mutually established or agreed that it was no longer necessary for Eurojust to coordinate the investigation and prosecutions, unless there is an obligation to provide Eurojust with this information in accordance with Article 21(5) or (6); (e) three years after the date on which operational personal data were transmitted in accordance with Article 21(5) or (6). 2. Observance of the storage deadlines referred to in paragraph 1 of this Article shall be reviewed constantly by appropriate automated processing conducted by Eurojust, particularly from the moment in which the case is closed by Eurojust. A review of the need to store the data shall also be carried out every three years after they were entered; the results of such reviews shall apply to the case as a whole. If operational personal data referred to in Article 27(4) are stored for a period exceeding five years, the EDPS shall be informed. 3. Before one of the storage deadlines referred to in paragraph 1 expires, Eurojust shall review the need for the continued storage of the operational personal data where and as long as this is necessary to perform its tasks. It may decide by way of derogation to store those data until the following review. The reasons for the continued storage shall be justified and recorded. If no decision is taken on the continued storage of operational personal data at the time of the review, those data shall be deleted automatically. 4. Where, in accordance with paragraph 3, operational personal data have been stored beyond the storage deadlines referred to in paragraph 1, the EDPS shall also carry out a review of the need to store those data every three years. 5. Once the deadline for the storage of the last item of automated data from the file has expired, all documents in the file shall be destroyed with the exception of any original documents which Eurojust has received from national authorities and which need to be returned to their provider. 6. Where Eurojust has coordinated an investigation or prosecutions, the national members concerned shall inform each other whenever they receive information that the case has been dismissed or that all judicial decisions related to the case have become final. 7. Paragraph 5 shall not apply where: (a) this would damage the interests of a data subject who requires protection; in such cases, the operational personal data shall be used only with the express and written consent of the data subject; (b) the accuracy of the operational personal data is contested by the data subject; in such cases paragraph 5 shall not apply for a period enabling Member States or Eurojust, as appropriate, to verify the accuracy of such data; (c) the operational personal data are to be maintained for purposes of proof or for the establishment, exercise or defence of legal claims; (d) the data subject opposes the erasure of the operational personal data and requests the restriction of their use instead; or (e) the operational personal data are further needed for archiving purposes in the public interest or statistical purposes. Article 30 Security of operational personal data Eurojust and Member States shall define mechanisms to ensure that the security measures referred to in Article 91 of Regulation (EU) 2018/1725 are addressed across information system boundaries. Article 31 Right of access by the data subject 1. Any data subject who wishes to exercise the right of access referred to in Article 80 of Regulation (EU) 2018/1725 to operational personal data that relate to the data subject and which have been processed by Eurojust may make a request to Eurojust or to the national supervisory authority in the Member State of the data subject’s choice. That authority shall refer the request to Eurojust without delay, and in any case within one month of its receipt. 2. The request shall be answered by Eurojust without undue delay and in any case within three months of its receipt by Eurojust. 3. The competent authorities of the Member States concerned shall be consulted by Eurojust on the decision to be taken in response to a request. The decision on access to data shall only be taken by Eurojust in close cooperation with the Member States directly concerned by the communication of such data. Where a Member State objects to Eurojust’s proposed decision, it shall notify Eurojust of the reasons for its objection. Eurojust shall comply with any such objection. The national members concerned shall subsequently notify the competent authorities of the content of Eurojust’s decision. 4. The national members concerned shall deal with the request and reach a decision on Eurojust’s behalf. Where the national members concerned are not in agreement, they shall refer the matter to the College, which shall take its decision on the request by a two-thirds majority. Article 32 Limitations to the right of access In the cases referred to in Article 81 of Regulation (EU) 2018/1725, Eurojust shall inform the data subject after consulting the competent authorities of the Member States concerned in accordance with Article 31(3) of this Regulation. Article 33 Right to restriction of processing Without prejudice to the exceptions set out in Article 29(7) of this Regulation, where the processing of operational personal data has been restricted under Article 82(3) of Regulation (EU) 2018/1725, such operational personal data shall only be processed for the protection of the rights of the data subject or another natural or legal person who is a party to the proceedings to which Eurojust is a party, or for the purposes laid down in Article 82(3) of Regulation (EU) 2018/1725. Article 34 Authorised access to operational personal data within Eurojust Only national members, their deputies, their Assistants and authorised seconded national experts, the persons referred to in Article 20(3) in so far as those persons are connected to the case management system and authorised Eurojust staff may, for the purpose of achieving Eurojust’s tasks, have access to operational personal data processed by Eurojust within the limits provided for in Articles 23, 24 and 25. Article 35 Records of categories of processing activities 1. Eurojust shall maintain a record of all categories of processing activities under its responsibility. That record shall contain all of the following information: (a) Eurojust’s contact details and the name and the contact details of its Data Protection Officer; (b) the purposes of the processing; (c) the description of the categories of data subjects and of the categories of operational personal data; (d) the categories of recipients to whom the operational personal data have been or will be disclosed including recipients in third countries or international organisations; (e) where applicable, transfers of operational personal data to a third country or an international organisation, including the identification of that third country or international organisation; (f) where possible, the envisaged time limits for erasure of the different categories of data; (g) where possible, a general description of the technical and organisational security measures referred to in Article 91 of Regulation (EU) 2018/1725. 2. The records referred to in paragraph 1 shall be in writing, including in electronic form. 3. Eurojust shall make the record available to the EDPS on request. Article 36 Designation of the Data Protection Officer 1. The Executive Board shall designate a Data Protection Officer. The Data Protection Officer shall be a member of staff specifically appointed for this purpose. In the performance of his or her duties, the Data Protection Officer shall act independently and may not receive any instructions. 2. The Data Protection Officer shall be selected on the basis of his or her professional qualities and, in particular, expert knowledge of data protection law and practice, and ability to fulfil his or her tasks under this Regulation, in particular those referred to in Article 38. 3. The selection of the Data Protection Officer shall not be liable to result in a conflict of interests between his or her duty as Data Protection Officer and any other official duties he or she may have, in particular in relation to the application of this Regulation. 4. The Data Protection Officer shall be appointed for a term of four years and shall be eligible for reappointment up to a maximum total term of eight years. The Data Protection Officer may be dismissed from his or her post by the Executive Board only with the agreement of the EDPS, if he or she no longer fulfils the conditions required for the performance of his or her duties. 5. Eurojust shall publish the contact details of the Data Protection Officer and communicate them to the EDPS. Article 37 Position of the Data Protection Officer 1. Eurojust shall ensure that the Data Protection Officer is involved properly and in a timely manner in all issues which relate to the protection of personal data. 2. Eurojust shall support the Data Protection Officer in performing the tasks referred to in Article 38 by providing the resources and staff necessary to carry out those tasks and by providing access to personal data and processing operations, and to maintain his or her expert knowledge. 3. Eurojust shall ensure that the Data Protection Officer does not receive any instructions regarding the carrying out of his or her tasks. The Data Protection Officer shall not be dismissed or penalised by the Executive Board for performing his or her tasks. The Data Protection Officer shall report directly to the College in relation to operational personal data and report to the Executive Board in relation to administrative personal data. 4. Data subjects may contact the Data Protection Officer with regard to all issues related to processing of their personal data and to the exercise of their rights under this Regulation and under Regulation (EU) 2018/1725. 5. The Executive Board shall adopt implementing rules concerning the Data Protection Officer. Those implementing rules shall in particular concern the selection procedure for the position of the Data Protection Officer, his or her dismissal, tasks, duties and powers, and safeguards for the independence of the Data Protection Officer. 6. The Data Protection Officer and his or her staff shall be bound by the obligation of confidentiality in accordance with Article 72. 7. The Data Protection Officer may be consulted by the controller and the processor, by the staff committee concerned and by any individual on any matter concerning the interpretation or application of this Regulation and Regulation (EU) 2018/1725 without them going through the official channels. No one shall suffer prejudice on account of a matter brought to the attention of the Data Protection Officer alleging that a breach of this Regulation or Regulation (EU) 2018/1725 has taken place. 8. After his or her designation the Data Protection Officer shall be registered with the EDPS by Eurojust. Article 38 Tasks of the Data Protection Officer 1. The Data Protection Officer shall in particular have the following tasks regarding the processing of personal data: (a) ensuring in an independent manner the compliance of Eurojust with the data protection provisions of this Regulation and Regulation (EU) 2018/1725 and with the relevant data protection provisions in Eurojust’s rules of procedure; this includes monitoring compliance with this Regulation, with Regulation (EU) 2018/1725, with other Union or national data protection provisions and with the policies of Eurojust in relation to the protection of personal data, including the assignment of responsibilities, awareness-raising and training of staff involved in processing operations, and related audits; (b) informing and advising Eurojust and staff who process personal data of their obligations pursuant to this Regulation, to Regulation (EU) 2018/1725 and to other Union or national data protection provisions; (c) providing advice where requested as regards the data protection impact assessment and monitoring its performance pursuant to Article 89 of Regulation (EU) 2018/1725; (d) ensuring that a record of the transfer and receipt of personal data is kept in accordance with the provisions to be laid down in Eurojust’s rules of procedure; (e) cooperating with the staff of Eurojust who are responsible for procedures, training and advice concerning data processing; (f) cooperating with the EDPS; (g) ensuring that data subjects are informed of their rights under this Regulation and Regulation (EU) 2018/1725; (h) acting as the contact point for the EDPS on issues relating to processing, including the prior consultation referred to in Article 90 of Regulation (EU) 2018/1725, and consulting where appropriate, with regard to any other matter; (i) providing advice where requested as regards the necessity of a notification or communication of a personal data breach pursuant to Articles 92 and 93 of Regulation (EU) 2018/1725; (j) preparing an annual report and communicating that report to the Executive Board, to the College and to the EDPS. 2. The Data Protection Officer shall carry out the functions provided for in Regulation (EU) 2018/1725 with regard to administrative personal data. 3. The Data Protection Officer and the staff members of Eurojust assisting the Data Protection Officer in the performance of his or her duties shall have access to the personal data processed by Eurojust and to its premises, to the extent necessary for the performance of their tasks. 4. If the Data Protection Officer considers that the provisions of Regulation (EU) 2018/1725 related to the processing of administrative personal data or that the provisions of this Regulation or of Article 3 and of Chapter IX of Regulation (EU) 2018/1725 related to the processing of operational personal data have not been complied with, he or she shall inform the Executive Board, requesting that it resolve the non-compliance within a specified time. If the Executive Board does not resolve the non-compliance within the specified time, the Data Protection Officer shall refer the matter to the EDPS. Article 39 Notification of a personal data breach to the authorities concerned 1. In the event of a personal data breach, Eurojust shall without undue delay notify the competent authorities of the Member States concerned of that breach. 2. The notification referred to in paragraph 1 shall, as a minimum: (a) describe the nature of the personal data breach including, where possible and appropriate, the categories and number of data subjects concerned and the categories and number of data records concerned; (b) describe the likely consequences of the personal data breach; (c) describe the measures proposed or taken by Eurojust to address the personal data breach; and (d) where appropriate, recommend measures to mitigate the possible adverse effects of the personal data breach. Article 40 Supervision by the EDPS 1. The EDPS shall be responsible for monitoring and ensuring the application of the provisions of this Regulation and Regulation (EU) 2018/1725 relating to the protection of fundamental rights and freedoms of natural persons with regard to processing of operational personal data by Eurojust, and for advising Eurojust and data subjects on all matters concerning the processing of operational personal data. To that end, the EDPS shall fulfil the duties set out in paragraph 2 of this Article, shall exercise the powers granted in paragraph 3 of this Article and shall cooperate with the national supervisory authorities in accordance with Article 42. 2. The EDPS shall have the following duties under this Regulation and Regulation (EU) 2018/1725: (a) hearing and investigating complaints, and informing the data subject of the outcome within a reasonable period; (b) conducting inquiries either on his or her own initiative or on the basis of a complaint, and informing the data subjects of the outcome within a reasonable period; (c) monitoring and ensuring the application of the provisions of this Regulation and Regulation (EU) 2018/1725 relating to the protection of natural persons with regard to the processing of operational personal data by Eurojust; (d) advising Eurojust, either on his or her own initiative or in response to a consultation, on all matters concerning the processing of operational personal data, in particular before Eurojust draws up internal rules relating to the protection of fundamental rights and freedoms with regard to the processing of operational personal data. 3. The EDPS may under this Regulation and Regulation (EU) 2018/1725, taking into account the implications for investigations and prosecutions in the Member States: (a) give advice to data subjects on the exercise of their rights; (b) refer a matter to Eurojust in the event of an alleged breach of the provisions governing the processing of operational personal data, and, where appropriate, make proposals for remedying that breach and for improving the protection of the data subjects; (c) consult Eurojust where requests to exercise certain rights in relation to operational personal data have been refused in breach of Article 31, 32 or 33 of this Regulation or Articles 77 to 82 or Article 84 of Regulation (EU) 2018/1725; (d) warn Eurojust; (e) order Eurojust to carry out the rectification, restriction or erasure of operational personal data which have been processed by Eurojust in breach of the provisions governing the processing of operational personal data and to notify such actions to third parties to whom such data have been disclosed, provided that this does not interfere with the tasks of Eurojust set out in Article 2; (f) refer the matter to the Court of Justice of the European Union (the ‘Court’) under the conditions set out in the TFEU; (g) intervene in actions brought before the Court. 4. The EDPS shall have access to the operational personal data processed by Eurojust and to its premises to the extent necessary for the performance of his or her tasks. 5. The EDPS shall draw up an annual report on his or her supervisory activities in relation to Eurojust. That report shall be part of the annual report of the EDPS referred to in Article 60 of Regulation (EU) 2018/1725. The national supervisory authorities shall be invited to make observations on this report before it becomes part of the annual report of the EDPS referred to in Article 60 of Regulation (EU) 2018/1725. The EDPS shall take utmost account of the observations made by national supervisory authorities and, in any case, shall refer to them in the annual report. 6. Eurojust shall cooperate with the EDPS in the performance of his or her tasks at his or her request. Article 41 Professional secrecy of the EDPS 1. The EDPS and his or her staff shall, both during and after their term of office, be subject to a duty of professional secrecy with regard to any confidential information which has come to their knowledge in the course of their performance of official duties. 2. The EDPS shall, in the exercise of his or her supervision powers, take into utmost account the secrecy of judicial inquiries and criminal proceedings, in accordance with Union or Member State law. Article 42 Cooperation between the EDPS and national supervisory authorities 1. The EDPS shall act in close cooperation with national supervisory authorities with respect to specific issues requiring national involvement, in particular if the EDPS or a national supervisory authority finds major discrepancies between practices of the Member States or potentially unlawful transfers using Eurojust’s communication channels, or in the context of questions raised by one or more national supervisory authorities on the implementation and interpretation of this Regulation. 2. In the cases referred to in paragraph 1, coordinated supervision shall be ensured in accordance with Article 62 of Regulation (EU) 2018/1725. 3. The EDPS shall keep national supervisory authorities fully informed of all issues that directly affect them or are otherwise relevant to them. Upon a request from one or more national supervisory authorities, the EDPS shall inform them on specific issues. 4. In cases relating to data originating from one or several Member States, including cases referred to in Article 43(3), the EDPS shall consult the national supervisory authorities concerned. The EDPS shall not decide on further action to be taken before those national supervisory authorities have informed the EDPS of their position, within a deadline specified by the EDPS. That deadline shall not be shorter than one month or longer than three months. The EDPS shall take utmost account of the position of the national supervisory authorities concerned. In cases where the EDPS intends not to follow their position, he or she shall inform them, provide a justification, and submit the matter to the European Data Protection Board. In cases which the EDPS considers to be extremely urgent, he or she may decide to take immediate action. In such cases, the EDPS shall immediately inform the national supervisory authorities concerned and substantiate the urgent nature of the situation and justify the action he or she has taken. 5. National supervisory authorities shall keep the EDPS informed of any actions they take with respect to the transfer, retrieval, or any other communication of operational personal data under this Regulation by the Member States. Article 43 Right to lodge a complaint with the EDPS with respect to operational personal data 1. Any data subject shall have the right to lodge a complaint with the EDPS, if he or she considers that the processing by Eurojust of operational personal data relating to him or her does not comply with this Regulation or Regulation (EU) 2018/1725. 2. Where a complaint relates to a decision referred to in Article 31, 32 or 33 of this Regulation or Article 80, 81 or 82 of Regulation (EU) 2018/1725, the EDPS shall consult the national supervisory authorities or the competent judicial body of the Member State that provided the data or the Member State directly concerned. In adopting his or her decision, which may extend to a refusal to communicate any information, the EDPS shall take into account the opinion of the national supervisory authority or of the competent judicial body. 3. Where a complaint relates to the processing of data provided by a Member State to Eurojust, the EDPS and the national supervisory authority of the Member State that provided the data, each acting within the scope of their respective competences shall ensure that the necessary checks on the lawfulness of the processing of the data have been carried out correctly. 4. Where a complaint relates to the processing of data provided to Eurojust by Union bodies, offices or agencies, by third countries or by international organisations or to the processing of data retrieved by Eurojust from publicly available sources, the EDPS shall ensure that Eurojust has correctly carried out the necessary checks on the lawfulness of the processing of the data. 5. The EDPS shall inform the data subject of the progress and outcome of the complaint, as well as the possibility of a judicial remedy pursuant to Article 44. Article 44 Right to judicial review against the EDPS Actions against the decisions of the EDPS concerning operational personal data shall be brought before the Court. Article 45 Responsibility in data protection matters 1. Eurojust shall process operational personal data in such a way that it can be established which authority provided the data or from where the data were retrieved. 2. Responsibility for the accuracy of operational personal data shall lie with: (a) Eurojust for operational personal data provided by a Member State, or by a Union institution, body, office or agency where the data provided has been altered in the course of processing by Eurojust; (b) the Member State or the Union institution, office, body or agency which provided the data to Eurojust, where the data provided has not been altered in the course of processing by Eurojust; (c) Eurojust for operational personal data provided by third countries or by international organisations, as well for operational personal data retrieved by Eurojust from publicly available sources. 3. Responsibility for compliance with Regulation (EU) 2018/1725 in relation to administrative personal data and for compliance with this Regulation and with Article 3 and Chapter IX of Regulation (EU) 2018/1725 in relation to operational personal data shall lie with Eurojust. Responsibility for the legality of a transfer of operational personal data shall lie: (a) where a Member State has provided the operational personal data concerned to Eurojust, with that Member State; (b) with Eurojust, where it has provided the operational personal data concerned to Member States, to Union institutions, bodies, offices or agencies, to third countries or to international organisations. 4. Subject to other provisions of this Regulation, Eurojust shall be responsible for all data processed by it. Article 46 Liability for unauthorised or incorrect processing of data 1. Eurojust shall be liable, in accordance with Article 340 TFEU, for any damage caused to an individual which results from the unauthorised or incorrect processing of data carried out by it. 2. Complaints against Eurojust on grounds of the liability referred to in paragraph 1 of this Article shall be heard by the Court in accordance with Article 268 TFEU. 3. Each Member State shall be liable, in accordance with its national law, for any damage caused to an individual which results from the unauthorised or incorrect processing carried out by it of data which were communicated to Eurojust. CHAPTER V RELATIONS WITH PARTNERS SECTION I Common provisions Article 47 Common provisions 1. In so far as necessary for the performance of its tasks, Eurojust may establish and maintain cooperative relations with Union institutions, bodies, offices and agencies in accordance with their respective objectives, and with the competent authorities of third countries and international organisations in accordance with the cooperation strategy referred to in Article 52. 2. In so far as relevant to the performance of its tasks and subject to any restrictions pursuant to Article 21(8) and Article 76, Eurojust may exchange any information with the entities referred to in paragraph 1 of this Article directly, with the exception of personal data. 3. For the purposes set out in paragraphs 1 and 2, Eurojust may conclude working arrangements with the entities referred to in paragraph 1. Such working arrangements shall not form the basis for allowing the exchange of personal data and shall not bind the Union or its Member States. 4. Eurojust may receive and process personal data received from the entities referred to in paragraph 1 in so far as necessary for the performance of its tasks, subject to the applicable data protection rules. 5. Personal data shall only be transferred by Eurojust to Union institutions, bodies, offices or agencies, to third countries or to international organisations if this is necessary for the performance of its tasks and is in accordance with Articles 55 and 56. If the data to be transferred have been provided by a Member State, Eurojust shall obtain the consent of the relevant competent authority in that Member State, unless the Member State has granted its prior authorisation to such onward transfer, either in general terms or subject to specific conditions. Such consent may be withdrawn at any time. 6. Where Member States, Union institutions, bodies, offices or agencies, third countries or international organisations have received personal data from Eurojust, onward transfers of such data to third parties shall be prohibited unless all of the following conditions have been met: (a) Eurojust has obtained prior consent from the Member State that provided the data; (b) Eurojust has given its explicit consent after considering the circumstances of the case at hand; (c) the onward transfer is only for a specific purpose that is not incompatible with the purpose for which the data were transmitted. SECTION II Relations with partners within the Union Article 48 Cooperation with the European Judicial Network and other Union networks involved in judicial cooperation in criminal matters 1. Eurojust and the European Judicial Network in criminal matters shall maintain privileged relations with each other, based on consultation and complementarity, especially between the national member, contact points of the European Judicial Network in the same Member State as the national member, and the national correspondents for Eurojust and the European Judicial Network. In order to ensure efficient cooperation, the following measures shall be taken: (a) on a case-by-case basis national members shall inform the contact points of the European Judicial Network of all cases which they consider the Network to be in a better position to deal with; (b) the Secretariat of the European Judicial Network shall form part of the staff of Eurojust; it shall function as a separate unit; it may draw on the administrative resources of Eurojust which are necessary for the performance of the European Judicial Network’s tasks, including for covering the costs of the plenary meetings of the Network; (c) contact points of the European Judicial Network may be invited on a case-by-case basis to attend Eurojust meetings; (d) Eurojust and the European Judicial Network may make use of the Eurojust national coordination system when determining under point (b) of Article 20(7) whether a request should be handled with the assistance of Eurojust or the European Judicial Network. 2. The Secretariat of the Network for joint investigation teams and the Secretariat of the Network set up by Decision 2002/494/JHA shall form part of the staff of Eurojust. Those secretariats shall function as separate units. They may draw on the administrative resources of Eurojust which are necessary for the performance of their tasks. The coordination of the secretariats shall be ensured by Eurojust. This paragraph applies to the secretariat of any relevant network involved in judicial cooperation in criminal matters for which Eurojust is to provide support in the form of a secretariat. Eurojust may support relevant European networks and bodies involved in judicial cooperation in criminal matters, including where appropriate by means of a secretariat hosted at Eurojust. 3. The network set up by Decision 2008/852/JHA may request that Eurojust provide a secretariat of the network. If such request is made, paragraph 2 shall apply. Article 49 Relations with Europol 1. Eurojust shall take all appropriate measures to enable Europol, within Europol’s mandate, to have indirect access, on the basis of a hit/no-hit system, to information provided to Eurojust, without prejudice to any restrictions indicated by the Member State, Union body, office or agency, third country or international organisation that provided the information in question. In the case of a hit, Eurojust shall initiate the procedure by which the information that generated the hit may be shared in accordance with the decision of the Member State, Union body, office or agency, third country or international organisation that provided the information to Eurojust. 2. Searches of information in accordance with paragraph 1 shall be carried out only for the purpose of identifying whether information available at Europol matches with information processed at Eurojust. 3. Eurojust shall allow searches in accordance with paragraph 1 only after obtaining from Europol information on which Europol staff members have been designated as authorised to perform such searches. 4. If during Eurojust’s information processing activities in respect of an individual investigation, Eurojust or a Member State identifies the need for coordination, cooperation or support in accordance with Europol’s mandate, Eurojust shall notify Europol thereof and shall initiate the procedure for sharing the information, in accordance with the decision of the Member State that provided the information. In such cases Eurojust shall consult with Europol. 5. Eurojust shall establish and maintain close cooperation with Europol to the extent relevant to performing the tasks of the two agencies and to achieving their objectives, taking account of the need to avoid duplication of effort. To that end, the Executive Director of Europol and the President of Eurojust shall meet on a regular basis to discuss issues of common concern. 6. Europol shall respect any restriction of access or use, whether in general or specific terms, that has been indicated by a Member State, Union body, office or agency, third country or international organisation, in relation to information that it has provided. Article 50 Relations with the EPPO 1. Eurojust shall establish and maintain a close relationship with the EPPO based on mutual cooperation within their respective mandates and competences and on the development of operational, administrative and management links between them as defined in this Article. To that end, the President of Eurojust and the European Chief Prosecutor shall meet on a regular basis to discuss issues of common interest. They shall meet at the request of the President of Eurojust or of the European Chief Prosecutor. 2. Eurojust shall treat requests for support from the EPPO without undue delay, and, where appropriate, shall treat such requests as if they had been received from a national authority competent for judicial cooperation. 3. Whenever necessary to support the cooperation established in accordance with paragraph 1 of this Article, Eurojust shall make use of the Eurojust national coordination system set up in accordance with Article 20, as well as the relations it has established with third countries, including its liaison magistrates 4. In operational matters relevant to the EPPO’s competences, Eurojust shall inform the EPPO of and, where appropriate, associate it with its activities concerning cross-border cases, including by: (a) sharing information on its cases, including personal data, in accordance with the relevant provisions in this Regulation; (b) requesting the EPPO to provide support. 5. Eurojust shall have indirect access to information in the EPPO’s case management system on the basis of a hit/no-hit system. Whenever a match is found between data entered into the case management system by the EPPO and data held by Eurojust, the fact that there is a match shall be communicated to both Eurojust and to the EPPO, as well as to the Member State which provided the data to Eurojust. Eurojust shall take appropriate measures to enable the EPPO to have indirect access to information in its case management system on the basis of a hit/no-hit system. 6. The EPPO may rely on the support and resources of the administration of Eurojust. To that end, Eurojust may provide services of common interest to the EPPO. The details shall be regulated by an arrangement. Article 51 Relations with other Union bodies, offices and agencies 1. Eurojust shall establish and maintain cooperative relations with the European Judicial Training Network. 2. OLAF shall contribute to Eurojust’s coordination work regarding the protection of the financial interests of the Union, in accordance with its mandate under Regulation (EU, Euratom) No 883/2013. 3. The European Border and Coast Guard Agency shall contribute to Eurojust’s work including by transmitting relevant information processed in accordance with its mandate and tasks under point (m) of Article 8(1) of Regulation (EU) 2016/1624 of the European Parliament and of the Council (21). The European Border and Coast Guard Agency’s processing of any personal data in connection therewith shall be regulated by Regulation (EU) 2018/1725. 4. For the purposes of receiving and transmitting information between Eurojust and OLAF, without prejudice to Article 8 of this Regulation, Member States shall ensure that the national members of Eurojust are regarded as competent authorities of the Member States solely for the purposes of Regulation (EU, Euratom) No 883/2013. The exchange of information between OLAF and national members shall be without prejudice to obligations to provide the information to other competent authorities under those Regulations. SECTION III International cooperation Article 52 Relations with the authorities of third countries and international organisations 1. Eurojust may establish and maintain cooperation with authorities of third countries and international organisations. To that end, Eurojust shall prepare a cooperation strategy every four years in consultation with the Commission, which specifies the third countries and international organisations with which there is an operational need for cooperation. 2. Eurojust may conclude working arrangements with the entities referred to in Article 47(1). 3. Eurojust may designate contact points in third countries in agreement with the competent authorities concerned, in order to facilitate cooperation in accordance with the operational needs of Eurojust. Article 53 Liaison magistrates posted to third countries 1. For the purpose of facilitating judicial cooperation with third countries in cases in which Eurojust is providing assistance in accordance with this Regulation, the College may post liaison magistrates to a third country subject to the existence of a working arrangement as referred to in Article 47(3) with the competent authorities of that third country. 2. The tasks of the liaison magistrates shall include any activity designed to encourage and accelerate any form of judicial cooperation in criminal matters, in particular by establishing direct links with the competent authorities of the third country concerned. In the performance of their tasks, the liaison magistrates may exchange operational personal data with the competent authorities of the third country concerned in accordance with Article 56. 3. The liaison magistrate referred to in paragraph 1 shall have experience of working with Eurojust and adequate knowledge of judicial cooperation and how Eurojust operates. The posting of a liaison magistrate on behalf of Eurojust shall be subject to the prior consent of the magistrate and of his or her Member State. 4. Where the liaison magistrate posted by Eurojust is selected among national members, deputies or Assistants: (a) the Member State concerned shall replace him or her in his or her function as a national member, deputy or Assistant; (b) he or she shall cease to be entitled to exercise the powers granted to him or her under Article 8. 5. Without prejudice to Article 110 of the Staff Regulations of Officials, the College shall draw up the terms and conditions for the posting of liaison magistrates, including their level of remuneration. The College shall adopt the necessary implementing arrangements in this respect in consultation with the Commission. 6. The activities of liaison magistrates posted by Eurojust shall be subject to the supervision of the EDPS. The liaison magistrates shall report to the College, which shall inform the European Parliament and the Council in the annual report and in an appropriate manner of their activities. The liaison magistrates shall inform national members and competent national authorities of all cases concerning their Member State. 7. The competent authorities of the Member States and liaison magistrates referred to in paragraph 1 may contact each other directly. In such cases, the liaison magistrate shall inform the national member concerned of such contacts. 8. The liaison magistrates referred to in paragraph 1 shall be connected to the case management system. Article 54 Requests for judicial cooperation to and from third countries 1. Eurojust may, with the agreement of the Member States concerned, coordinate the execution of requests for judicial cooperation issued by a third country where such requests require execution in at least two Member States as part of the same investigation. Such requests may also be transmitted to Eurojust by a competent national authority. 2. In urgent cases and in accordance with Article 19, the OCC may receive and transmit the requests referred to in paragraph 1 of this Article if they have been issued by a third country which has concluded a cooperation agreement or working arrangement with Eurojust. 3. Without prejudice to Article 3(5), where requests for judicial cooperation which relate to the same investigation and which require execution in a third country are made by the Member State concerned, Eurojust shall facilitate judicial cooperation with that third country. SECTION IV Transfers of personal data Article 55 Transmission of operational personal data to Union institutions, bodies, offices and agencies 1. Subject to any further restrictions pursuant to this Regulation, in particular pursuant to Articles 21(8), 47(5) and 76, Eurojust shall only transmit operational personal data to another Union institution, body, office or agency if the data are necessary for the legitimate performance of tasks covered by the competence of the other Union institution, body, office or agency. 2. Where the operational personal data are transmitted following a request from another Union institution, body, office or agency, both the controller and the recipient shall bear the responsibility for the legitimacy of that transfer. Eurojust shall be required to verify the competence of the other Union institution, body, office or agency and to make a provisional evaluation of the necessity of the transmission of the operational personal data. If doubts arise as to this necessity, Eurojust shall seek further information from the recipient. The other Union institution, body, office or agency shall ensure that the necessity of the transmission of the operational personal data can be subsequently verified. 3. The other Union institution, body, office or agency shall process the operational personal data only for the purposes for which they were transmitted. Article 56 General principles for transfers of operational personal data to third countries and international organisations 1. Eurojust may transfer operational personal data to a third country or international organisation, subject to compliance with the applicable data protection rules and the other provisions of this Regulation, and only where the following conditions are met: (a) the transfer is necessary for the performance of Eurojust’s tasks; (b) the authority of the third country or the international organisation to which the operational personal data are transferred is competent in law enforcement and criminal matters; (c) where the operational personal data to be transferred in accordance with this Article have been transmitted or made available to Eurojust by a Member State, Eurojust shall obtain prior authorisation for the transfer from the relevant competent authority of that Member State in compliance with its national law, unless that Member State has authorised such transfers in general terms or subject to specific conditions; (d) in the case of an onward transfer to another third country or international organisation by a third country or international organisation, Eurojust shall require the transferring third country or international organisation to obtain the prior authorisation of Eurojust for that onward transfer. Eurojust shall only provide authorisation under point (d) with the prior authorisation of the Member State from which the data originate after taking due account of all relevant factors, including the seriousness of the criminal offence, the purpose for which the operational personal data were originally transferred and the level of personal data protection in the third country or international organisation to which the operational personal data are to be transferred onward. 2. Subject to the conditions set out in paragraph 1 of this Article, Eurojust may transfer operational personal data to a third country or to an international organisation only where one of the following applies: (a) the Commission has decided pursuant to Article 57 that the third country or international organisation in question ensures an adequate level of protection, or in the absence of such an adequacy decision, appropriate safeguards have been provided for or exist in accordance with Article 58(1), or in the absence of both an adequacy decision and of such appropriate safeguards, a derogation for specific situations applies pursuant to Article 59(1); (b) a cooperation agreement allowing for the exchange of operational personal data has been concluded before 12 December 2019 between Eurojust and that third country or international organisation, in accordance with Article 26a of Decision 2002/187/JHA; or (c) an international agreement has been concluded between the Union and the third country or international organisation pursuant to Article 218 TFEU that provides for adequate safeguards with respect to the protection of privacy and fundamental rights and freedoms of individuals. 3. The working arrangements referred to in Article 47(3) may be used to set out modalities to implement the agreements or adequacy decisions referred to in paragraph 2 of this Article. 4. Eurojust may in urgent cases transfer operational personal data without prior authorisation from a Member State in accordance with point (c) of paragraph 1. Eurojust shall only do so if the transfer of the operational personal data is necessary for the prevention of an immediate and serious threat to the public security of a Member State or of a third country or to the essential interests of a Member State, and where the prior authorisation cannot be obtained in good time. The authority responsible for giving prior authorisation shall be informed without delay. 5. Member States and Union institutions, bodies, offices and agencies shall not transfer operational personal data they have received from Eurojust onward to a third country or an international organisation,. As an exception, they may make such a transfer in cases where Eurojust has authorised it after taking into due account all relevant factors, including the seriousness of the criminal offence, the purpose for which the operational personal data were originally transmitted and the level of personal data protection in the third country or international organisation to which the operational personal data are transferred onward. 6. Articles 57, 58 and 59 shall apply in order to ensure that the level of protection of natural persons ensured by this Regulation and by Union law is not undermined. Article 57 Transfers on the basis of an adequacy decision Eurojust may transfer operational personal data to a third country or to an international organisation where the Commission has decided in accordance with Article 36 of Directive (EU) 2016/680 that the third country, a territory or one or more specified sectors within that third country, or the international organisation in question ensures an adequate level of protection. Article 58 Transfers subject to appropriate safeguards 1. In the absence of an adequacy decision, Eurojust may transfer operational personal data to a third country or an international organisation where: (a) appropriate safeguards with regard to the protection of operational personal data are provided for in a legally binding instrument; or (b) Eurojust has assessed all the circumstances surrounding the transfer of operational personal data and has concluded that appropriate safeguards exist with regard to the protection of operational personal data. 2. Eurojust shall inform the EDPS about categories of transfers under point (b) of paragraph 1. 3. When a transfer is based on point (b) of paragraph 1, such a transfer shall be documented and the documentation shall be made available to the EDPS on request. The documentation shall include a record of the date and time of the transfer and information about the receiving competent authority, about the justification for the transfer and about the operational personal data transferred. Article 59 Derogations for specific situations 1. In the absence of an adequacy decision, or of appropriate safeguards pursuant to Article 58, Eurojust may transfer operational personal data to a third country or an international organisation only on the condition that the transfer is necessary: (a) in order to protect the vital interests of the data subject or another person; (b) to safeguard legitimate interests of the data subject; (c) for the prevention of an immediate and serious threat to public security of a Member State or a third country; or (d) in individual cases for the performance of the tasks of Eurojust, unless Eurojust determines that the fundamental rights and freedoms of the data subject concerned override the public interest in the transfer. 2. Where a transfer is based on paragraph 1, such a transfer shall be documented and the documentation shall be made available to the EDPS on request. The documentation shall include a record of the date and time of the transfer, and information about the receiving competent authority, about the justification for the transfer and about the operational personal data transferred. CHAPTER VI FINANCIAL PROVISIONS Article 60 Budget 1. Estimates of all the revenue and expenditure of Eurojust shall be prepared for each financial year, corresponding to the calendar year, and shall be shown in Eurojust’s budget. 2. Eurojust’s budget shall be balanced in terms of revenue and of expenditure. 3. Without prejudice to other resources, Eurojust’s revenue shall comprise: (a) a contribution from the Union entered in the general budget of the Union; (b) any voluntary financial contribution from the Member States; (c) charges for publications and any service provided by Eurojust; (d) ad hoc grants. 4. The expenditure of Eurojust shall include staff remuneration, administrative and infrastructure expenses and operating costs, including funding for joint investigation teams. Article 61 Establishment of the budget 1. Each year the Administrative Director shall draw up a draft statement of estimates of Eurojust’s revenue and expenditure for the following financial year, including the establishment plan, and shall send it to the Executive Board. The European Judicial Network and other Union networks involved in judicial cooperation in criminal matters referred to in Article 48 shall be informed of the parts related to their activities in due time before the estimate is forwarded to the Commission. 2. The Executive Board shall, on the basis of the draft statement of estimates, review the provisional draft estimate of Eurojust’s revenue and expenditure for the following financial year, which it shall forward to the College for adoption. 3. The provisional draft estimate of Eurojust’s revenue and expenditure shall be sent to the Commission by no later than 31 January each year. Eurojust shall send the final draft estimate, which shall include a draft establishment plan, to the Commission by 31 March of the same year. 4. The Commission shall send the statement of estimates to the European Parliament and to the Council (the ‘budgetary authority’) together with the draft general budget of the Union. 5. On the basis of the statement of estimates, the Commission shall enter in the draft general budget of the Union the estimates it considers necessary for the establishment plan and the amount of the contribution to be charged to the general budget, which it shall place before the budgetary authority in accordance with Articles 313 and 314 TFEU. 6. The budgetary authority shall authorise the appropriations for the contribution from the Union to Eurojust. 7. The budgetary authority shall adopt Eurojust’s establishment plan. Eurojust’s budget shall be adopted by the College. It shall become final following the final adoption of the general budget of the Union. Where necessary, Eurojust’s budget shall be adjusted by the College accordingly. 8. Article 88 of Commission Delegated Regulation (EU) No 1271/2013 (22) shall apply to any building project likely to have significant implications for Eurojust’s budget. Article 62 Implementation of the budget The Administrative Director shall act as the authorising officer of Eurojust and shall implement Eurojust’s budget under his or her own responsibility, within the limits authorised in the budget. Article 63 Presentation of accounts and discharge 1. Eurojust’s accounting officer shall send the provisional accounts for the financial year (year N) to the Commission’s Accounting Officer and to the Court of Auditors by 1 March of the following financial year (year N + 1). 2. Eurojust shall send the report on the budgetary and financial management for year N to the European Parliament, the Council and the Court of Auditors by 31 March of year N + 1. 3. The Commission’s Accounting Officer shall send Eurojust’s provisional accounts for year N, consolidated with the Commission’s accounts, to the Court of Auditors by 31 March of year N + 1. 4. In accordance with Article 246(1) of Regulation (EU, Euratom) 2018/1046, the Court of Auditors shall make its observations on Eurojust’s provisional accounts by 1 June of year N + 1. 5. On receipt of the Court of Auditors’ observations on Eurojust’s provisional accounts pursuant to Article 246 of Regulation (EU, Euratom) 2018/1046, the Administrative Director shall draw up Eurojust’s final accounts under his or her own responsibility and shall submit them to the Executive Board for an opinion. 6. The Executive Board shall deliver an opinion on Eurojust’s final accounts. 7. The Administrative Director shall, by 1 July of year N + 1, send the final accounts for year N to the European Parliament, to the Council, to the Commission and to the Court of Auditors, together with the Executive Board’s opinion. 8. The final accounts for year N shall be published in the Official Journal of the European Union by 15 November of year N + 1. 9. The Administrative Director shall send the Court of Auditors a reply to its observations by 30 September of year N + 1. The Administrative Director shall also send this reply to the Executive Board and to the Commission. 10. At the European Parliament’s request, the Administrative Director shall submit to it any information required for the smooth application of the discharge procedure for the financial year in question in accordance with Article 261(3) of Regulation (EU, Euratom) 2018/1046. 11. On a recommendation from the Council acting by a qualified majority, the European Parliament shall, before 15 May of year N + 2, grant a discharge to the Administrative Director in respect of the implementation of the budget for year N. 12. The discharge of Eurojust’s budget shall be granted by the European Parliament on a recommendation of the Council following a procedure comparable to that provided for in Article 319 TFEU and Articles 260, 261 and 262 of Regulation (EU, Euratom) 2018/1046, and based on the audit report of the Court of Auditors. If the European Parliament refuses to grant the discharge by 15 May of year N + 2, the Administrative Director shall be invited to explain his or her position to the College, which shall take its final decision on the position of the Administrative Director in light of the circumstances. Article 64 Financial rules 1. The financial rules applicable to Eurojust shall be adopted by the Executive Board in accordance with Delegated Regulation (EU) No 1271/2013 after consultation with the Commission. Those financial rules shall not depart from Delegated Regulation (EU) No 1271/2013 unless such departure is specifically required for Eurojust’s operation and the Commission has given its prior consent. In respect of the financial support to be given to joint investigation teams’ activities, Eurojust and Europol shall jointly establish the rules and conditions upon which applications for such support are to be processed. 2. Eurojust may award grants related to the fulfilment of its tasks under Article 4(1). Grants provided for tasks relating to point (f) of Article 4(1) may be awarded to the Member States without a call for proposals. CHAPTER VII STAFF PROVISIONS Article 65 General provisions 1. The Staff Regulations of Officials and the Conditions of Employment of Other Servants, as well as the rules adopted by agreement between the institutions of the Union for giving effect to the Staff Regulations of Officials and the Conditions of Employment of Other Servants shall apply to the staff of Eurojust. 2. Eurojust staff shall consist of staff recruited according to the rules and regulations applicable to officials and other servants of the Union, taking into account all the criteria referred to in Article 27 of the Staff Regulations of Officials, including their geographical distribution. Article 66 Seconded national experts and other staff 1. In addition to its own staff, Eurojust may make use of seconded national experts or other staff not employed by Eurojust. 2. The College shall adopt a decision laying down rules on the secondment of national experts to Eurojust and on the use of other staff, in particular to avoid potential conflicts of interest. 3. Eurojust shall take appropriate administrative measures, inter alia, through training and prevention strategies, to avoid conflicts of interest, including conflicts of interests relating to post-employment issues. CHAPTER VIII EVALUATION AND REPORTING Article 67 Involvement of the Union institutions and national parliaments 1. Eurojust shall transmit its annual report to the European Parliament, to the Council and to national parliaments, which may present observations and conclusions. 2. Upon his or her election, the newly elected President of Eurojust shall make a statement before the competent committee or committees of the European Parliament and answer questions put by its members. Discussions shall not refer directly or indirectly to concrete actions taken in relation to specific operational cases. 3. The President of Eurojust shall appear once a year for the joint evaluation of the activities of Eurojust by the European Parliament and national parliaments within the framework of an interparliamentary committee meeting, to discuss Eurojust’s current activities and to present its annual report or other key documents of Eurojust. Discussions shall not refer directly or indirectly to concrete actions taken in relation to specific operational cases. 4. In addition to the other obligations of information and consultation set out in this Regulation, Eurojust shall transmit to the European Parliament and to national parliaments in their respective official languages for their information: (a) the results of studies and strategic projects elaborated or commissioned by Eurojust; (b) the programming document referred to in Article 15; (c) working arrangements concluded with third parties. Article 68 Opinions on proposed legislative acts The Commission and the Member States exercising their rights on the basis of point (b) of Article 76 TFEU may request Eurojust’s opinion on all proposed legislative acts referred to in Article 76 TFEU. Article 69 Evaluation and review 1. By 13 December 2024, and every 5 years thereafter, the Commission shall commission an evaluation of the implementation and impact of this Regulation, and the effectiveness and efficiency of Eurojust and its working practices. The College shall be heard in the evaluation. The evaluation may, in particular, address the possible need to modify the mandate of Eurojust, and the financial implications of any such modification. 2. The Commission shall forward the evaluation report together with its conclusions to the European Parliament, to national parliaments, to the Council and to the College. The findings of the evaluation shall be made public. CHAPTER IX GENERAL AND FINAL PROVISIONS Article 70 Privileges and immunities Protocol No 7 on the privileges and immunities of the European Union, annexed to the TEU and to the TFEU, shall apply to Eurojust and its staff. Article 71 Language arrangements 1. Council Regulation No 1 (23) shall apply to Eurojust. 2. The College shall decide Eurojust’s internal language arrangements by a two-thirds majority of its members. 3. The translation services required for the functioning of Eurojust shall be provided by the Translation Centre for the bodies of the European Union, as established by Council Regulation (EC) No 2965/94 (24), unless the unavailability of the Translation Centre requires another solution to be found. Article 72 Confidentiality 1. The national members and their deputies and Assistants referred to in Article 7, Eurojust staff, national correspondents, seconded national experts, liaison magistrates, the Data Protection Officer, and the members and staff of the EDPS shall be bound by an obligation of confidentiality with respect to any information which has come to their knowledge in the course of the performance of their tasks. 2. The obligation of confidentiality shall apply to all persons and to all bodies that work with Eurojust. 3. The obligation of confidentiality shall also apply after leaving office or employment and after the termination of the activities of the persons referred to in paragraphs 1 and 2. 4. The obligation of confidentiality shall apply to all information received or exchanged by Eurojust, unless that information has already lawfully been made public or is accessible to the public. Article 73 Conditions of confidentiality of national proceedings 1. Without prejudice to Article 21(3), where information is received or exchanged via Eurojust, the authority of the Member State which provided the information may stipulate conditions, pursuant to its national law, on the use by the receiving authority of that information in national proceedings. 2. The authority of the Member State which receives the information referred to in paragraph 1 shall be bound by those conditions. Article 74 Transparency 1. Regulation (EC) No 1049/2001 of the European Parliament and the Council (25) shall apply to documents held by Eurojust. 2. The Executive Board shall, within six months of the date of its first meeting, prepare the detailed rules for applying Regulation (EC) No 1049/2001 for adoption by the College. 3. Decisions taken by Eurojust under Article 8 of Regulation (EC) No 1049/2001 may be the subject of a complaint to the European Ombudsman or of an action before the Court, under the conditions laid down in Articles 228 and 263 TFEU respectively. 4. Eurojust shall publish on its website a list of the Executive Board members and summaries of the outcome of the meetings of the Executive Board. The publication of those summaries shall be temporarily or permanently omitted or restricted if such publication would risk jeopardising the performance of Eurojust’s tasks, taking into account its obligations of discretion and confidentiality and the operational character of Eurojust. Article 75 OLAF and the Court of Auditors 1. In order to facilitate the combating of fraud, corruption and other unlawful activities under Regulation (EU, Euratom) No 883/2013, within six months from the entry into force of this Regulation, Eurojust shall accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti-fraud Office (OLAF) (26). Eurojust shall adopt appropriate provisions that apply to all national members, their deputies and Assistants, all seconded national experts and all Eurojust staff, using the template set out in the Annex to that Agreement. 2. The Court of Auditors shall have the power of audit, on the basis of documents and on the spot, over all grant beneficiaries, contractors and subcontractors who have received Union funds from Eurojust. 3. OLAF may carry out investigations, including on-the-spot checks and inspections, in accordance with the provisions and procedures laid down in Regulation (EU, Euratom) No 883/2013 and Council Regulation (Euratom, EC) No 2185/96 (27), with a view to establishing whether there have been any irregularities affecting the financial interests of the Union in connection with expenditure funded by Eurojust. 4. Without prejudice to paragraphs 1, 2 and 3, working arrangements with third countries or international organisations, the contracts, grant agreements and grant decisions of Eurojust shall contain provisions expressly empowering the Court of Auditors and OLAF to conduct such audits and investigations, according to their respective competences. 5. The staff of Eurojust, the Administrative Director and the members of the College and Executive Board shall, without delay and without their responsibility being called into question as a result, notify OLAF and the EPPO of any suspicion of irregular or illegal activity within their respective mandate, which has come to their attention in the fulfilment of their duties. Article 76 Rules on the protection of sensitive non-classified information and classified information 1. Eurojust shall establish internal rules on the handling and confidentiality of information and on the protection of sensitive non-classified information, including the creation and processing of such information at Eurojust. 2. Eurojust shall establish internal rules on the protection of EU classified information which shall be consistent with Council Decision 2013/488/EU (28) in order to ensure an equivalent level of protection for such information. Article 77 Administrative inquiries The administrative activities of Eurojust shall be subject to the inquiries of the European Ombudsman in accordance with Article 228 TFEU. Article 78 Liability other than liability for unauthorised or incorrect processing of data 1. Eurojust’s contractual liability shall be governed by the law applicable to the contract in question. 2. The Court shall have jurisdiction to give judgment pursuant to any arbitration clause contained in a contract concluded by Eurojust. 3. In the case of non-contractual liability, Eurojust shall, in accordance with the general principles common to the laws of the Member States and independently of any liability under Article 46, make good any damage caused by Eurojust or its staff in the performance of their duties. 4. Paragraph 3 shall also apply to damage caused through the fault of a national member, a deputy or an Assistant in the performance of their duties. However, when he or she is acting on the basis of the powers granted to him or her pursuant to Article 8, his or her Member State shall reimburse Eurojust the sums which Eurojust has paid to make good such damage. 5. The Court shall have jurisdiction in disputes over compensation for damages referred to in paragraph 3. 6. The national courts of the Member States competent to deal with disputes involving Eurojust’s liability as referred to in this Article shall be determined by reference to Regulation (EU) No 1215/2012 of the European Parliament and of the Council (29). 7. The personal liability of Eurojust’s staff towards Eurojust shall be governed by the applicable provisions laid down in the Staff Regulations of Officials and Conditions of Employment of Other Servants. Article 79 Headquarters agreement and operating conditions 1. The seat of Eurojust shall be The Hague, the Netherlands. 2. The necessary arrangements concerning the accommodation to be provided for Eurojust in the Netherlands and the facilities to be made available by the Netherlands together with the specific rules applicable in the Netherlands to the Administrative Director, members of the College, Eurojust staff and members of their families shall be laid down in a headquarters agreement between Eurojust and the Netherlands concluded once the College’s approval is obtained. Article 80 Transitional arrangements 1. Eurojust as established by this Regulation shall be the general legal successor in respect of all contracts concluded by, liabilities incumbent upon, and properties acquired by Eurojust as established by Decision 2002/187/JHA. 2. The national members of Eurojust as established by Decision 2002/187/JHA who have been seconded by each Member State under that Decision shall take the role of national members of Eurojust under Section II of Chapter II of this Regulation. Their terms of office may be extended once under Article 7(5) of this Regulation after the entry into force of this Regulation, irrespective of a previous extension. 3. The President and Vice-Presidents of Eurojust as established by Decision 2002/187/JHA at the time of the entry into force of this Regulation shall take the role of the President and Vice-Presidents of Eurojust under Article 11 of this Regulation, until the expiry of their terms of office in accordance with that Decision. They may be re-elected once after the entry into force of this Regulation under Article 11(4) of this Regulation, irrespective of a previous re-election. 4. The Administrative Director who was last appointed under Article 29 of Decision 2002/187/JHA shall take the role of the Administrative Director under Article 17 of this Regulation until the expiry of his or her term of office as decided under that Decision. The term of office of that Administrative Director may be extended once after the entry into force of this Regulation. 5. This Regulation shall not affect the validity of agreements concluded by Eurojust as established by Decision 2002/187/JHA. In particular, all international agreements concluded by Eurojust before 12 December 2019 shall remain valid. 6. The discharge procedure in respect of the budgets approved on the basis of Article 35 of Decision 2002/187/JHA shall be carried out in accordance with the rules established by Article 36 thereof. 7. This Regulation shall not affect employment contracts which have been concluded under Decision 2002/187/JHA prior to the entry into force of this Regulation. The Data Protection Officer who was last appointed under Article 17 of that Decision shall take the role of the Data Protection Officer under Article 36 of this Regulation. Article 81 Replacement and repeal 1. Decision 2002/187/JHA is hereby replaced for the Member States bound by this Regulation with effect from 12 December 2019. Therefore, Decision 2002/187/JHA is repealed with effect from 12 December 2019. 2. With regard to the Member States bound by this Regulation, references to the Decision referred to in paragraph 1 shall be construed as references to this Regulation. Article 82 Entry into force and application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 12 December 2019. This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties. Done at Strasbourg, 14 November 2018. For the European Parliament The President A. TAJANI For the Council The President K. EDTSTADLER (1) Position of the European Parliament of 4 October 2018 (not yet published in the Official Journal) and decision of the Council of 6 November 2018. (2) Council Decision 2002/187/JHA of 28 February 2002 setting up Eurojust with a view to reinforcing the fight against serious crime (OJ L 63, 6.3.2002, p. 1). (3) Council Decision 2003/659/JHA of 18 June 2003 amending Decision 2002/187/JHA setting up Eurojust with a view to reinforcing the fight against serious crime (OJ L 245, 29.9.2003, p. 44). (4) Council Decision 2009/426/JHA of 16 December 2008 on the strengthening of Eurojust and amending Decision 2002/187/JHA setting up Eurojust with a view to reinforcing the fight against serious crime (OJ L 138, 4.6.2009, p. 14). (5) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1). (6) Council Decision 2002/494/JHA of 13 June 2002 setting up a European network of contact points in respect of persons responsible for genocide, crimes against humanity and war crimes (OJ L 167, 26.6.2002, p. 1). (7) Council Decision 2007/845/JHA of 6 December 2007 concerning cooperation between Asset Recovery Offices of the Member States in the field of tracing and identification of proceeds from, or other property related to, crime (OJ L 332, 18.12.2007, p. 103). (8) Council Decision 2008/852/JHA of 24 October 2008 on a contact-point network against corruption (OJ L 301, 12.11.2008, p. 38). (9) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89). (10) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002 (see page 39 of this Official Journal). (11) Council Common Position 2005/69/JHA of 24 January 2005 on exchanging certain data with Interpol (OJ L 27, 29.1.2005, p. 61). (12) Council Decision 2007/533/JHA of 12 June 2007 on the establishment, operation and use of the second generation Schengen Information System (SIS II) (OJ L 205, 7.8.2007, p. 63). (13) Council Joint Action 96/277/JHA of 22 April 1996 concerning a framework for the exchange of liaison magistrates to improve judicial cooperation between the Member States of the European Union (OJ L 105, 27.4.1996, p. 1). (14) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (15) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (16) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (17) Directive 2014/41/EU of the European Parliament and of the Council of 3 April 2014 regarding the European Investigation Order in criminal matters (OJ L 130, 1.5.2014, p. 1). (18) OJ L 56, 4.3.1968, p. 1. (19) Council Decision 2005/671/JHA of 20 September 2005 on the exchange of information and cooperation concerning terrorist offences (OJ L 253, 29.9.2005, p. 22). (20) Council Decision 2008/976/JHA of 16 December 2008 on the European Judicial Network (OJ L 348, 24.12.2008, p. 130). (21) Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, p. 1). (22) Commission Delegated Regulation (EU) No 1271/2013 of 30 September 2013 on the framework financial regulation for the bodies referred to in Article 208 of Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (OJ L 328, 7.12.2013, p. 42). (23) Council Regulation No 1 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385). (24) Council Regulation (EC) No 2965/94 of 28 November 1994 setting up a Translation Centre for bodies of the European Union (OJ L 314, 7.12.1994, p. 1). (25) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43). (26) OJ L 136, 31.5.1999, p. 15. (27) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (28) Council Decision 2013/488/EU of 23 September 2013 on the security rules for protecting EU classified information (OJ L 274, 15.10.2013, p. 1). (29) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). ANNEX I List of forms of serious crime with which Eurojust is competent to deal in accordance with Article 3(1): — terrorism, — organised crime, — drug trafficking, — money-laundering activities, — crime connected with nuclear and radioactive substances, — immigrant smuggling, — trafficking in human beings, — motor vehicle crime, — murder and grievous bodily injury, — illicit trade in human organs and tissue, — kidnapping, illegal restraint and hostage taking, — racism and xenophobia, — robbery and aggravated theft, — illicit trafficking in cultural goods, including antiquities and works of art, — swindling and fraud, — crime against the financial interests of the Union, — insider dealing and financial market manipulation, — racketeering and extortion, — counterfeiting and product piracy, — forgery of administrative documents and trafficking therein, — forgery of money and means of payment, — computer crime, — corruption, — illicit trafficking in arms, ammunition and explosives, — illicit trafficking in endangered animal species, — illicit trafficking in endangered plant species and varieties, — environmental crime, including ship source pollution, — illicit trafficking in hormonal substances and other growth promoters, — sexual abuse and sexual exploitation, including child abuse material and solicitation of children for sexual purposes, — genocide, crimes against humanity and war crimes. ANNEX II CATEGORIES OF PERSONAL DATA REFERRED TO IN ARTICLE 27 1. (a) surname, maiden name, given names and any alias or assumed names; (b) date and place of birth; (c) nationality; (d) sex; (e) place of residence, profession and whereabouts of the person concerned; (f) social security number or other official numbers used in the Member State to identify individuals, driving licences, identification documents and passport data, customs and Tax Identification Numbers; (g) information concerning legal persons if it includes information relating to identified or identifiable individuals who are the subject of a judicial investigation or prosecution; (h) details of accounts held with banks or other financial institutions; (i) description and nature of the alleged offences, the date on which they were committed, the criminal category of the offences and the progress of the investigations; (j) the facts pointing to an international extension of the case; (k) details relating to alleged membership of a criminal organisation; (l) telephone numbers, email addresses, traffic data and location data, as well as any related data necessary to identify the subscriber or user; (m) vehicle registration data; (n) DNA profiles established from the non-coding part of DNA, photographs and fingerprints. 2. (a) surname, maiden name, given names and any alias or assumed names; (b) date and place of birth; (c) nationality; (d) sex; (e) place of residence, profession and whereabouts of the person concerned; (f) the description and nature of the offences involving the person concerned, the date on which the offences were committed, the criminal category of the offences and the progress of the investigations; (g) social security number or other official numbers used by the Member States to identify individuals, driving licences, identification documents and passport data, customs and Tax Identification Numbers; (h) details of accounts held with banks and other financial institutions; (i) telephone numbers, email addresses, traffic data and location data, as well as any related data necessary to identify the subscriber or user; (j) vehicle registration data.

Eurojust (reform) Eurojust (reform) SUMMARY OF: Regulation (EU) 2018/1727 — the European Union Agency for Criminal Justice Cooperation (Eurojust) — replacing and repealing Council Decision 2002/187/JHA WHAT IS THE AIM OF THE REGULATION? It aims to tackle serious cross-border crime more efficiently by changing the structure of Eurojust and enabling the College of Eurojust to concentrate more on operational matters. It also takes into account the establishment of the European Public Prosecutor’s Office (EPPO) and new rules for data protection in the European institutions and agencies. It also makes determining arrangements for involving the European Parliament and national parliaments in the evaluation of Eurojust’s activities. It replaces and repeals Council Decision 2002/187/JHA. KEY POINTS Role of Eurojust Based on operations conducted and information supplied by the EU countries’ authorities and by Europol, the EPPO and OLAF, supporting and strengthening coordination and cooperation between national investigating and prosecuting authorities in relation to serious crime which Eurojust is competent to deal with (see below), where that crime: affects 2 or more EU countries; orrequires prosecution on common bases. Carrying out its tasks at the request of the competent authorities of the EU countries, on its own initiative or at the request of the EPPO within the limits of the EPPO’s competence. Eurojust’s operational tasks include: cooperating closely with the EPPO on issues of competence; cooperating and consulting with the European Judicial Network in criminal matters; cooperating with EU institutions, bodies, offices and agencies, as well as networks established in the area of freedom, security and justice; supporting EU countries’ action in combating forms of serious crime for which it is competent (e.g. terrorism; money laundering activities; trafficking in human beings; organ trafficking; drug and firearms trafficking); providing operational, technical and financial support to EU countries’ cross-border operations and investigations, including to joint investigation teams. Competence Annex 1 of the Regulation sets out the forms of serious crime which Eurojust is competent to deal with in accordance with Article 3(1) of the Regulation. When the EPPO assumes its investigative and prosecutorial tasks, Eurojust will not exercise its competence for crimes for which the EPPO exercises its competence, except: in cases involving EU countries not participating in enhanced cooperation on the establishment of the EPPO; andat the request of those EU countries or at the request of the EPPO. Eurojust will exercise its competence for crimes affecting the financial interests of the EU in cases involving EU countries which participate in enhanced cooperation on the establishment of the EPPO, but for which the EPPO is not competent or decides not to exercise its competence. Eurojust will establish and maintain a close relationship with the EPPO based on mutual cooperation within their respective mandates. Structure and organisation Eurojust comprises: the national members;the College — consisting of all national members, plus 1 representative of the European Commission when the College is only carrying out its management functions, and not its operational functions;the Executive Board;the Administrative Director. The terms of office of the national members and their deputies is 5 years, renewable once. The Commission is represented on both the College and Executive Board. The Executive Board is responsible for taking administrative decisions to ensure the proper functioning of Eurojust. Processing of personal data The updated rules take into account the new data protection rules for EU institutions and agencies. EU countries are responsible for the accuracy of the data they transfer to Eurojust, for keeping those data up to date and for the legality of transmitting those data to Eurojust. Eurojust is responsible for the accuracy of data provided by other data suppliers or resulting from its own analyses or data collection and for keeping those data up to date. Eurojust should ensure that data are processed fairly and lawfully, and are collected and processed for a specific purpose. A data subject must have the right of access to operational personal data about him or her which are processed by Eurojust. Democratic control To increase the transparency and democratic oversight of Eurojust, its activities will be jointly evaluated by the European Parliament and national parliaments. FROM WHEN DOES THE REGULATION APPLY? It applies from 12 December 2019. BACKGROUND For further information, see: About Eurojust (Eurojust). MAIN DOCUMENT Regulation (EU) 2018/1727 of the European Parliament and of the Council of 14 November 2018 on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA (OJ L 295, 21.11.2018, pp. 138-183) RELATED DOCUMENTS Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, pp. 39-98) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, pp. 1-71) Council Decision 2009/426/JHA of 16 December 2008 on the strengthening of Eurojust and amending Decision 2002/187/JHA setting up Eurojust with a view to reinforcing the fight against serious crime (OJ L 138, 4.6.2009, pp. 14-32) Council Decision 2002/187/JHA of 28 February 2002 setting up Eurojust with a view to reinforcing the fight against serious crime (OJ L 63, 6.3.2002, pp. 1-13) Successive amendments to Decision 2002/187/JHA have been incorporated in the basic text. This consolidated version is of documentary value only. last update 21.03.2019

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26.3.2021 EN Official Journal of the European Union L 107/30 REGULATION (EU) 2021/523 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 173 and the third paragraph of Article 175 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), After consulting the Committee of the Regions, Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The COVID-19 pandemic is a major shock to the global and Union economy and is having a major social and economic impact across Member States and regions. Due to the necessary containment measures, economic activity in the Union dropped significantly. The contraction in Union GDP in 2020 is expected to be around 7,4 %, far deeper than during the financial crisis in 2009. Investment activity has dropped significantly. Vulnerabilities such as the over-reliance on non-diversified external supply sources and a lack of critical infrastructure need to be addressed, in particular for small and medium-sized enterprises (SMEs), including micro-enterprises, for instance by diversifying and strengthening strategic value chains, to improve the Union’s emergency response as well as the resilience of the entire economy, while maintaining its openness to competition and trade in line with its rules. Even before the pandemic, while a recovery in investment-to-GDP ratios in the Union could be observed, it remained below what might be expected in a strong recovery and was insufficient to compensate for years of underinvestment following the 2009 crisis. More importantly, the current investment levels and forecasts do not cover the Union’s needs for structural investment to restart and sustain long-term growth in the face of technological change and global competitiveness, including for innovation, skills, infrastructure, SMEs and the need to address key societal challenges such as sustainability and population ageing. Consequently, in order to achieve the Union’s policy objectives and to support a swift, sustainable, inclusive, lasting and healthy economic recovery, support is necessary to address market failures and suboptimal investment situations and to reduce the investment gap in targeted sectors. (2) Evaluations have underlined that the variety of financial instruments delivered under the 2014-2020 Multiannual Financial Framework period has led to some overlaps in their scope. That variety has also produced complexity for intermediaries and final recipients who were confronted with different eligibility and reporting rules. The absence of compatible rules also hampered the combination of several Union funds, although such combinations would have been beneficial in order to support projects in need of different types of funding. Therefore, a single fund, the InvestEU Fund, which builds on the experience of the European Fund for Strategic Investments (EFSI) set up under the Investment Plan for Europe, should be set up in order to provide more efficiently functioning support to final recipients by integrating and simplifying the financing offered under a single budgetary guarantee scheme, thereby improving the impact of Union support while reducing the cost to the Union payable from the budget. (3) In recent years, the Union has adopted ambitious strategies to complete the internal market and to stimulate sustainable and inclusive growth and jobs. Such strategies include ‘Europe 2020 – A strategy for smart, sustainable and inclusive growth’ of 3 March 2010, ‘Action Plan on Building a Capital Markets Union’ of 30 September 2015, ‘Closing the loop – An EU action plan for the Circular Economy’ of 2 December 2015, ‘A European Strategy for Low-Emission Mobility’ of 20 July 2016, ‘Space Strategy for Europe’ of 26 October 2016, ‘Clean Energy for all Europeans’ of 30 November 2016, ‘European Defence Action Plan’ of 30 November 2016, ‘Launching the European Defence Fund’ of 7 June 2017, the Interinstitutional Proclamation on the European Pillar of Social Rights of 13 December 2017, ‘A new European Agenda for Culture’ of 22 May 2018, the ‘European Green Deal’ of 11 December 2019, the ‘European Green Deal Investment Plan’ of 14 January 2020, the ‘Strong Social Europe for Just Transitions’ of 14 January 2020, the strategy for ‘Shaping Europe’s digital future’, ‘A European Strategy for Data’ and the White Paper ‘On Artificial Intelligence - A European approach to excellence and trust’ of 19 February 2020, ‘A New Industrial Strategy for Europe’ of 10 March 2020 and ‘SME Strategy for a sustainable and digital Europe’ of 10 March 2020. The InvestEU Fund should exploit and reinforce synergies between those mutually reinforcing strategies by providing support for investment and access to financing. In addition, the Union has adopted Regulation (EU) 2020/852 of the European Parliament and of the Council (3). (4) At Union level, the European Semester of economic policy coordination is the framework for identifying national reform priorities and monitoring their implementation. Member States, where appropriate in cooperation with local and regional authorities, develop their own national multiannual investment strategies in support of those reform priorities. Those strategies should be presented alongside the yearly national reform programmes as a way of outlining and coordinating priority investment projects that are to be supported by national funding, Union funding, or both. Those strategies should also use Union funding in a coherent manner and maximise the added value of the financial support to be received in particular from the European structural and investment funds, the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council (4) and the InvestEU Programme. (5) The InvestEU Fund should contribute to improving the competitiveness and socio-economic convergence and cohesion of the Union, including in the fields of innovation and digitisation, to the efficient use of resources in accordance with the circular economy, to the sustainability and inclusiveness of the Union’s economic growth and to the social resilience and integration of Union capital markets, including through solutions that address the fragmentation of Union capital markets and that diversify sources of financing for Union enterprises. To that end, the InvestEU Fund should support projects that are technically and economically viable by providing a framework for the use of debt, risk sharing and equity and quasi-equity instruments backed up by a guarantee from the Union budget and by financial contributions from implementing partners as relevant. The InvestEU Fund should be demand-driven, while at the same time focused on providing strategic, long-term benefits in relation to key areas of Union policy which would otherwise not be funded or would be insufficiently funded, thereby contributing to meeting the Union’s policy objectives. Support from the InvestEU Fund should cover a wide range of sectors and regions, but should avoid excessive sectoral or geographical concentration and should facilitate access to financing of projects composed of partner entities in multiple regions across the Union, including projects that foster the development of networks, clusters and digital innovation hubs. (6) The cultural and creative sectors are key as well as fast growing sectors in the Union that can play an important part in ensuring a sustainable recovery, generating both economic and cultural value from intellectual property and individual creativity. However, restrictions on social contacts put in place during the COVID-19 crisis have had a significant negative economic impact on those sectors. Moreover, the intangible nature of assets in those sectors limits the access of SMEs and organisations from those sectors to private financing which is essential to be able to invest, scale up and compete at an international level. The InvestEU Programme should continue to facilitate access to finance for SMEs and organisations from those sectors. The cultural and creative, audiovisual and media sectors are essential for freedom of speech and cultural diversity and for building democratic and cohesive societies in the digital age, and are an intrinsic part of our sovereignty and autonomy. Investment in those sectors would determine their competitiveness and their long-term capacity to produce and distribute high-quality content to wide audiences across national borders. (7) With a view to fostering sustainable and inclusive growth, investment and employment, and thereby contributing to improved well-being, to fairer income distribution and to greater economic, social and territorial cohesion in the Union, the InvestEU Fund should support investments in tangible and intangible assets, including in cultural heritage. Projects funded by the InvestEU Fund should meet Union environmental and social standards, including standards on labour rights. Interventions through the InvestEU Fund should complement Union support delivered through grants. (8) The Union endorsed the objectives set out in the United Nations 2030 Agenda for Sustainable Development (the ‘2030 Agenda’), its Sustainable Development Goals (SDGs) and the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (5) (Paris Agreement) as well as the Sendai Framework for Disaster Risk Reduction 2015-2030. To achieve those objectives, as well as the objectives set out in the environmental policies of the Union, action pursuing sustainable development needs to be significantly stepped up. Therefore, the principles of sustainable development should feature prominently in the design of the InvestEU Fund. (9) The InvestEU Programme should contribute to building a sustainable finance system in the Union which supports the reorientation of private capital towards sustainable investments in accordance with the objectives set out in the communication of the Commission of 8 March 2018 entitled ‘Action Plan: Financing Sustainable Growth’ and the communication of the Commission of 14 January 2020 on the European Green Deal Investment Plan. (10) Reflecting the importance of tackling climate change in line with the Union’s commitments to implement the Paris Agreement, and the commitment to the United Nations Sustainable Development Goals, as well as the objective of EU climate neutrality by 2050 and the Union’s new 2030 climate targets, actions under this Regulation should contribute to the achievement of a target of 30 % of all MFF expenditure being spent on mainstreaming climate objectives and the ambition of 7,5 % of the budget reflecting biodiversity expenditures in 2024 and 10 % in 2026 and 2027, while considering the existing overlaps between climate and biodiversity goals. Actions under the InvestEU Programme are expected to contribute at least 30 % of the overall financial envelope of the InvestEU Programme to climate objectives. (11) The contribution of the InvestEU Fund to the achievement of the climate target will be tracked through a Union climate tracking system to be developed by the Commission in cooperation with potential implementing partners, appropriately using the criteria established by Regulation (EU) 2020/852 for determining whether an economic activity is environmentally sustainable. The InvestEU Programme should also contribute to the implementation of other dimensions of the SDGs. (12) According to the 2018 Global Risks Report issued by the World Economic Forum, five of the ten most critical risks threatening the global economy relate to the environment. Such risks include the pollution of air, soil, inland waters and oceans, extreme weather events, biodiversity losses and failures of climate-change mitigation and adaptation. Environmental principles are strongly embedded in the Treaties and many of the Union’s policies. Therefore, the mainstreaming of environmental objectives should be promoted in operations related to the InvestEU Fund. Environmental protection and the prevention and management of related risks should be integrated in the preparation and implementation of investments. The Union should also track its biodiversity-related and air pollution control-related expenditures in order to fulfil the reporting obligations under the Convention on Biological Diversity (6) and under Directive (EU) 2016/2284 of the European Parliament and of the Council (7). Investment allocated to environmental sustainability objectives should therefore be tracked using common methodologies that are consistent with methodologies developed under other Union programmes that apply to climate, biodiversity and air pollution management in order to allow the assessment of the individual and combined impact of investments on the principal components of natural capital, namely air, water, land and biodiversity. (13) Investment projects that receive substantial Union support, in particular in the area of infrastructure, should be screened by the implementing partner to determine whether they have an environmental, climate or social impact. Investment projects that have such an impact should be subject to sustainability proofing in accordance with guidance that should be developed by the Commission in close cooperation with potential implementing partners under the InvestEU Programme. This guidance should appropriately use the criteria established by Regulation (EU) 2020/852 for determining whether an economic activity is environmentally sustainable, including the principle of ‘do no significant harm’, and consistent with the guidance developed for other programmes of the Union. Consistent with the principle of proportionality, such guidance should include adequate provisions for avoiding undue administrative burdens, and projects below a certain size as to be defined in the guidance should be excluded from the sustainability proofing. Where an implementing partner concludes that no sustainability proofing is to be carried out, it should provide a justification to the investment committee established for the InvestEU Fund (the ‘Investment Committee’). Operations that are inconsistent with the achievement of the climate objectives should not be eligible for support under this Regulation. (14) Low infrastructure investment rates in the Union during the financial crisis and again during the COVID-19 crisis have undermined the Union’s ability to boost sustainable growth, its efforts towards climate neutrality, its competitiveness and convergence and the creation of jobs. This also creates the risk of consolidating imbalances and divergences and inequalities within and between Member States, impacting on long-term development at Union, national or regional level. Sizeable investments in Union infrastructure, in particular with regard to interconnection and energy efficiency and to creating a Single European Transport Area, are essential to meeting the Union’s sustainability targets, including the Union’s commitments towards the SDGs, and the 2030 energy and climate targets. Accordingly, support from the InvestEU Fund should target investments in transport, energy, including energy efficiency and renewable energy sources and other safe and sustainable low-emission energy sources, environmental infrastructure, infrastructure related to climate action, maritime infrastructure and digital infrastructure, including fast and ultra-fast broadband connectivity throughout the Union, to accelerate the digital transformation of the Union economy. The InvestEU Programme should prioritise areas that are under-invested, and in which additional investment is required. To maximise the impact and added value of Union financing support, it is appropriate to promote a streamlined investment process that enables visibility of the project pipeline and maximises synergies across relevant Union programmes in areas such as transport, energy and digitisation. Bearing in mind threats to safety and security, investment projects receiving Union support should include measures for infrastructure resilience, including infrastructure maintenance and safety, and should take into account principles for the protection of citizens in public spaces. This should be complementary to the efforts made by other Union funds that provide support for security components of investments in public spaces, transport, energy and other critical infrastructure, such as the European Regional Development Fund. (15) Where appropriate, the InvestEU Programme should contribute to the objectives of Directive (EU) 2018/2001 of the European Parliament and of the Council (8) and Regulation (EU) 2018/1999 of the European Parliament and of the Council (9), as well as promote energy efficiency in investment decisions. (16) Genuine multimodality is an opportunity to create an efficient and environmentally friendly transport network that uses the maximum potential of all means of transport and generates synergy between them. The InvestEU Programme should support investments in multimodal transport hubs, which – in spite of their significant economic potential and business cases – carry a significant risk for private investors. The InvestEU Programme should also contribute to the development and deployment of Intelligent Transport Systems (ITS). The InvestEU Programme should help to boost efforts to design and apply technologies that help to improve the safety of vehicles and road infrastructure. (17) The InvestEU Programme should contribute to Union policies concerning seas and oceans through the development of projects and enterprises in the area of the blue economy, and the Sustainable Blue Economy Finance Principles. This may include interventions in the area of maritime entrepreneurship and industry, an innovative and competitive maritime industry, as well as renewable marine energy and circular economy. (18) Although the level of overall investment in the Union was increasing before the COVID-19 crisis, investment in higher-risk activities such as research and innovation was still inadequate and is now expected to have suffered a significant hit as a result of the crisis. Research and innovation have a crucial role to play in overcoming the crisis, consolidating the resilience of the Union to tackle future challenges and creating the necessary technologies to achieve Union policies and goals. The InvestEU Fund should contribute to reaching the overall target of investing at least 3 % of Union GDP in research and innovation. The achievement of that target would require Member States and the private sector to proceed with their own reinforced investment actions in research, development and innovation, to avoid underinvestment in research and innovation, which is damaging to the industrial and economic competitiveness of the Union and the quality of life of its citizens. The InvestEU Fund should provide appropriate financial products to cover different stages of the innovation cycle and a wide range of stakeholders, in particular to allow the upscaling of and deployment of solutions at a commercial scale in the Union in order to make such solutions competitive on world markets and to promote Union excellence in sustainable technologies at a global level, in synergy with Horizon Europe to be established by a Regulation of the European Parliament and of the Council establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (the ‘Horizon Europe Regulation’), including the European Innovation Council. In that regard, the experience gained from the financial instruments, such as InnovFin – EU Finance for Innovators, deployed under Horizon 2020 to facilitate and accelerate access to finance for innovative businesses should serve as a strong basis to deliver this targeted support. (19) Tourism, including the hospitality industry, is an area of great importance for the Union economy and is currently experiencing a particularly severe contraction as a result of the COVID-19 pandemic. That contraction is particularly damaging for SMEs and family businesses and has caused large-scale unemployment. The InvestEU Programme should contribute to strengthening the recovery, long-term competitiveness and sustainability of the sector, and its value chains, by supporting operations promoting sustainable, innovative and digital tourism including innovative measures to reduce the climate and environmental footprint of the sector. (20) A significant effort is urgently needed to invest in and boost the digital transformation and to distribute the benefits of it to all Union citizens and businesses. The strong policy framework of the Digital Single Market Strategy should now be matched by investment of a similar ambition, including in artificial intelligence in line with the Digital Europe Programme to be established by a Regulation of the European Parliament and of the Council establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240. (21) SMEs represent over 99 % of businesses in the Union and their economic value is significant and crucial. However, they face difficulties when accessing finance because of their perceived high risk and lack of sufficient collateral. Additional challenges arise from the need for SMEs and social economy enterprises to stay competitive by engaging in digitisation, internationalisation, transformation in a logic of circular economy, innovation activities and skilling up their workforce. SMEs have been particularly badly hit by the COVID-19 crisis. Moreover, SMEs and social economy enterprises have access to a more limited set of financing sources than larger enterprises, because they typically do not issue bonds, and have only limited access to stock exchanges and large institutional investors. Innovative solutions such as the acquisition of a business or ownership stake in a business by employees are also increasingly common for SMEs and social economy enterprises. The difficulty in accessing finance is even greater for those SMEs whose activities focus on intangible assets. SMEs in the Union rely heavily on banks and on debt financing in the form of bank overdrafts, bank loans or leasing. Supporting SMEs that face the above challenges by making it easier for them to gain access to finance and by providing more diversified sources of funding is necessary to increase the ability of SMEs to finance their creation, growth, innovation and sustainable development, ensure their competitiveness and withstand economic shocks to make the economy and the financial system more resilient during economic downturns and to maintain SMEs’ ability to create jobs and social well-being. This Regulation is also complementary to the initiatives already undertaken in the context of the Capital Markets Union. The InvestEU Fund should therefore build on successful Union programmes, such as the Programme for the Competitiveness of Enterprises and SMEs (COSME); provide support to digital start-ups and innovative SMEs to enable them to better compete and scale up; provide working capital and investment throughout the life cycle of a company; provide financing for leasing transactions; and provide an opportunity to focus on specific, more targeted financial products. It should also maximise the firepower of public/private fund vehicles, such as the SME IPO (Initial Public Offering) Fund, seeking to support SMEs through channelling more private and public equity. (22) As set out in the Commission’s Reflection paper on the social dimension of Europe of 26 April 2017, the Communication on European Pillar of Social Rights, the Union framework for the UN Convention on the Rights of Persons with Disabilities and the Communication on ‘Strong Social Europe for Just Transitions’ of 14 January 2020, building a more inclusive and fair Union is a key priority for the Union to tackle inequality and foster social inclusion policies in Europe. Inequality of opportunities affects in particular access to education, training, culture, employment, health and social services. Investment in the social, skills and human capital-related economy, as well as in the integration of vulnerable populations in the society, can enhance economic opportunities, especially if coordinated at Union level. The COVID-19 crisis has revealed a significant need for investment in social infrastructure. The InvestEU Fund should be used to support investment in education and training, including the re-skilling and upskilling of workers, inter alia in regions depending on a carbon intensive economy and affected by the structural transition to a low-carbon economy. It should be used to support projects that generate positive social impacts and enhance social inclusion by helping to increase employment across all regions, in particular among the unskilled and long-term unemployed, and to improve the situation with regard to gender equality, equal opportunities, non-discrimination, accessibility, intergenerational solidarity, the health and social services sector, social housing, homelessness, digital inclusiveness, community development, the role and place of young people in society as well as vulnerable people, including third country nationals. The InvestEU Programme should also support European culture and creativity that has a social goal. (23) The COVID-19 crisis has had a particularly serious impact on women, from both a social and an economic perspective. Bearing that in mind, the InvestEU Programme should contribute to the achievement of the Union’s policies on equality between women and men, inter alia, by addressing the digital gap between them and by helping to encourage female creativity and entrepreneurial potential. (24) To counter the negative effects of profound transformations of societies in the Union and of the labour market in the coming decade, it is necessary to invest in human capital, social infrastructure, microfinance, ethical and social enterprise finance and new social economy business models, including social impact investment and social outcomes contracting. The InvestEU Programme should strengthen nascent social market ecosystem to increase the supply of and access to finance to micro- and social enterprises and social solidarity institutions, in order to meet the demand of those who need it the most. The report of the High-Level Task Force on Investing in Social Infrastructure in Europe of January 2018 entitled ‘Boosting Investment in Social Infrastructure in Europe’ has identified a total investment gap of at least EUR 1,5 trillion in social infrastructure and services for the period between 2018 and 2030, including education, training, health and housing. This calls for support, including at the Union level. Therefore, the collective power of public, commercial and philanthropic capital, as well as support from foundations and from alternative types of finance providers such as ethical, social and sustainable actors, should be harnessed to support the development of the social market value chain and a more resilient Union. (25) In the economic crisis caused by the COVID-19 pandemic, market allocation of resources is not fully efficient and perceived risk impairs private investment flow significantly. Under such circumstances, the key feature of the InvestEU Fund of de-risking economically viable projects to crowd in private finance is particularly valuable, inter alia in order to counteract the risk of an asymmetric recovery. The InvestEU Programme should be able to provide crucial support to companies in the recovery phase, including capital support for SMEs that were negatively affected by the COVID-19 crisis and were not already in difficulty in State aid terms at the end of 2019, and at the same time ensure a strong focus of investors on the Union’s medium- and long-term policy priorities such as the European Green Deal, the European Green Deal Investment Plan, the Strategy on shaping Europe’s digital future, the New Industrial Strategy for Europe, and the Strong Social Europe for Just Transitions, taking account of the principle of ‘do no significant harm’. It should significantly increase the risk-taking capacity of the European Investment Bank (EIB) Group and national promotional banks and institutions and other implementing partners in support of economic recovery. (26) The deep contraction in Union GDP resulting from the COVID-19 crisis renders adverse social effects inevitable. The COVID-19 pandemic has shown the need for strategic vulnerabilities to be urgently and efficiently addressed in order to improve the Union’s emergency response as well as the resilience and sustainability of the entire economy. Only a resilient, sustainable, inclusive and integrated Union economy can preserve the integrity of the internal market and the level playing field also to the benefit of the hardest-hit Member States and regions. (27) The InvestEU Fund should operate through four policy windows that mirror the key Union policy priorities, namely, sustainable infrastructure; research, innovation and digitisation; SMEs; and social investment and skills. (28) Although the SME policy window should primarily focus on benefitting SMEs, small mid-cap companies should also be eligible under it. Mid-cap companies should be eligible for support under the other three policy windows. (29) As set out in the European Green Deal and the European Green Deal Investment Plan, a Just Transition Mechanism is to be established in order to address the social, economic and environmental consequences of reaching the Union’s 2030 climate target and its target of achieving climate neutrality by 2050. That mechanism would be composed of three pillars, namely a Just Transition Fund to be established by a Regulation of the European Parliament and of the Council establishing the Just Transition Fund (the ‘Just Transition Fund Regulation’) (pillar 1), a dedicated just transition scheme under the InvestEU Programme (pillar 2) and a public sector loan facility to be established by a Regulation of the European Parliament and of the Council on the public sector loan facility under the Just Transition Mechanism (the ‘Public Sector Loan Facility Regulation for 2021-2027’) (pillar 3). That mechanism should focus on the regions that are most affected by the transition given their dependence on fossil fuels, including coal, peat and oil shale or greenhouse gas-intensive industrial processes, and that have less capacity to finance the necessary investments. The just transition scheme should also provide support for financing to generate investment to the benefit of just transition territories. The InvestEU Advisory Hub should provide for the possibility for the respective territories to benefit from technical assistance. (30) To implement pillar 2 under the Just Transition Mechanism, a dedicated just transition scheme under the InvestEU Programme should be established horizontally across all policy windows, supporting additional investment to benefit the territories identified in territorial just transition plans, established in accordance with the Just Transition Fund Regulation. That scheme should enable investments in a wide range of projects, in line with the eligibility criteria of the InvestEU Programme. Projects in territories identified in territorial just transition plans, or projects that benefit the transition of those territories, even if they are not located in the territories themselves, may benefit from the Scheme, but only when funding outside the just transition territories is key to the transition in those territories. (31) It should be possible to support strategic investments, including important projects of common European interest, under any policy window, particularly in view of the green and digital transitions and the need to enhance competitiveness and resilience, promote entrepreneurship and job creation and strengthen strategic value chains. (32) Each policy window should be composed of two compartments, that is to say an EU compartment and a Member State compartment. The EU compartment should address Union-wide or Member State specific market failures or suboptimal investment situations in a proportionate manner. Operations supported should have a clear Union added value. The Member State compartment should give Member States as well as regional authorities via their Member State the possibility of contributing a share of their resources from the funds under shared management to the provisioning for the EU guarantee and of using the EU guarantee for financing or investment operations in order to address specific market failures or suboptimal investment situations in their own territories, including in vulnerable and remote areas such as the outermost regions of the Union, as to be set out in the contribution agreement, in order to achieve objectives of the funds under shared management. The Member State compartment should also give Member States the possibility of contributing other additional amounts, including those made available pursuant to Regulation (EU) 2021/241, to the provisioning for the EU guarantee and of using the EU guarantee for financing or investment operations for the purposes laid down in the contribution agreement, which should include, where relevant, the purposes of measures under a recovery and resilience plan. This could, inter alia, allow for capital support for SMEs that were negatively affected by the COVID-19 crisis and were not already in difficulty in State aid terms at the end of 2019. Operations supported by the InvestEU Fund through either EU or Member State compartments should not duplicate or crowd out private financing or distort competition in the internal market. (33) The Member State compartment should be specifically designed to allow the use of funds under shared management or other additional amounts contributed by Member States, including those made available pursuant to Regulation (EU) 2021/241 to provision a guarantee issued by the Union. That possibility would increase the added value of the EU guarantee by providing support under it to a wider range of final recipients and projects and diversifying the means of achieving the objectives of the funds under shared management or recovery and resilience plans, while ensuring a consistent risk management of the contingent liabilities by implementing the EU guarantee under indirect management. The Union should guarantee the financing and investment operations provided for in the guarantee agreements concluded between the Commission and implementing partners under the Member State compartment. The funds under shared management or other additional amounts contributed by Member States, including those made available pursuant to Regulation (EU) 2021/241, should provide the provisioning for the guarantee, following a provisioning rate determined by the Commission and set out in the contribution agreement concluded with the Member State, based on the nature of the operations and the resulting expected losses. The Member State would assume losses above the expected losses by issuing a back-to-back guarantee in favour of the Union that should remain in place as long as any financing and investment operations under that Member State compartment are outstanding. Such arrangements should be concluded in a single contribution agreement with each Member State that voluntarily chooses such option. The contribution agreement should encompass the one or more specific guarantee agreements to be implemented within the Member State concerned on the basis of the rules of the InvestEU Fund, and any regional ring-fencing. The setting out of the provisioning rate on a case-by-case basis requires a derogation from Article 211(1) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (10) (the ‘Financial Regulation’). This set-up provides also a single set of rules for budgetary guarantees supported by funds that are managed centrally or by funds under shared management, which would facilitate their combination. The provisioning for an EU guarantee relating to a Member State compartment underpinned by other additional amounts contributed by Member States, including those made available pursuant to Regulation (EU) 2021/241, should constitute external assigned revenue. (34) A partnership between the Commission and the EIB Group should be established, drawing on the relative strengths of each partner to ensure maximum policy impact, deployment efficiency, and appropriate budgetary and risk management oversight, which should support effective and inclusive direct access to the EU guarantee. (35) The Union represented by the Commission should be in a position to participate in a capital increase of the European Investment Fund (EIF) in order to allow the EIF to continue supporting the European economy and its recovery. The main aim of the increase would be to allow the EIF to contribute to the implementation of the InvestEU Programme. The Union should be able to maintain its overall share in the EIF capital. A sufficient financial envelope to this effect should be foreseen in the Multiannual Financial Framework for 2021-2027. On 3 December 2020, the Board of Directors of the EIF decided to propose to the shareholders an increase in the authorised capital of the EIF that would result in a cash injection of EUR 1 250 000 000. The price of the new shares is based on the net asset value formula agreed among the shareholders of the EIF and consists of the paid-in part and the share premium. In accordance with Article 7 of the EIF Statutes, for each subscribed share, 20 % of the nominal value must be paid in. (36) The Commission should seek the views of other potential implementing partners along with the EIB Group on investment guidelines, the climate tracking system, the sustainability proofing guidance documents and common methodologies, as appropriate, with a view to ensuring inclusiveness and operationality until the governance bodies have been set up, after which the involvement of implementing partners should take place within the framework of the Advisory Board and the Steering Board of the InvestEU Programme. (37) The InvestEU Fund should be open to contributions from third countries that are members of the European Free Trade Association, acceding countries, candidates and potential candidates, countries covered by the European Neighbourhood Policy and other countries, in accordance with the conditions agreed between the Union and those countries, in particular in view of the positive impact of such opening on the Member States’ economies. This should allow continuing cooperation with the relevant countries, where appropriate, in particular in the fields of research and innovation as well as SMEs. (38) This Regulation lays down a financial envelope for other measures of the InvestEU Programme than the provisioning of the EU guarantee, which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (11), for the European Parliament and the Council during the annual budgetary procedure. (39) EUR 2 672 292 573 in current prices of the EU guarantee should be provisioned by resources from the additional allocation provided in accordance with Article 5 of and Annex II to Council Regulation (EU, Euratom) 2020/2093 (12) corresponding to an amount of EUR 1 000 000 000 in 2018 prices. An amount of EUR 63 800 000 in current prices of the total allocation to the InvestEU Advisory Hub of EUR 430 000 000 in current prices should be provided from that amount. (40) The EU guarantee of EUR 26 152 310 073 in current prices for the EU compartment is expected to mobilise more than EUR 372 000 000 000 of additional investment across the Union and should be indicatively allocated between the policy windows. (41) On 18 April 2019, the Commission declared that ‘without prejudice to the prerogatives of the Council in the implementation of the Stability and Growth Pact (SGP), one-off contributions by Member States, either by a Member State or by national promotional banks classified in the general government sector or acting on behalf of a Member State, into thematic or multi-country investment platforms should in principle qualify as one-off measures within the meaning of Articles 5(1) and 9(1) of Council Regulation (EC) No 1466/97 (13) and Article 3(4) of Council Regulation (EC) No 1467/97 (14). In addition, without prejudice to the prerogatives of the Council in the implementation of the SGP, the Commission will consider to what extent the same treatment as for the EFSI in the context of the Commission communication on flexibility can be applied to the InvestEU Programme as the successor instrument to the EFSI with regard to one-off contributions provided by Member States in cash to finance an additional amount of the EU guarantee for the purposes of the Member State compartment.’. (42) The EU guarantee underpinning the InvestEU Fund should be implemented indirectly by the Commission relying on implementing partners with outreach to financial intermediaries, where applicable, and final recipients. The selection of the implementing partners should be transparent and free from any conflict of interest. The Commission should conclude a guarantee agreement allocating guarantee capacity from the InvestEU Fund with each implementing partner to support its financing and investment operations that meet the InvestEU Fund eligibility criteria and contribute to meeting its objectives. The management of the risk related to the EU guarantee should not hamper direct access to the EU guarantee by the implementing partners. Once the EU guarantee is granted under the EU compartment to implementing partners, they should be fully responsible for the whole investment process and the due diligence related to the financing and investment operations. The InvestEU Fund should support projects that typically have a higher risk profile than the projects supported by the normal operations of the implementing partners and that could not have been carried out during the period in which the EU guarantee could be used, or could not have been carried out to the same extent, by other public or private sources without support from the InvestEU Fund. (43) The InvestEU Fund should be provided with a governance structure, the function of which should be commensurate with its sole purpose of ensuring the appropriate use of the EU guarantee, in line with ensuring the political independence of investment decisions. That governance structure should be composed of an Advisory Board, a Steering Board and a fully independent Investment Committee. The overall composition of the governance structure should strive to achieve gender balance. The governance structure should not encroach upon or interfere with the decision-making of the EIB Group or other implementing partners, and should not be a substitute for their respective governing bodies. (44) An Advisory Board consisting of representatives of the implementing partners, representatives of Member States, one expert appointed by the European Economic and Social Committee and one expert appointed by the Committee of the Regions should be established in order to exchange information and exchange views on the take-up of the financial products deployed under the InvestEU Fund and to discuss evolving needs and new products, including specific territorial market gaps. (45) In order to be able to constitute the Advisory Board from the start, the Commission should appoint the representatives of the potential implementing partners for a temporary period of one year. Thereafter, the implementing partners having signed guarantee agreements would take over that responsibility. (46) A Steering Board composed of representatives of the Commission, representatives of implementing partners and one non-voting expert appointed by the European Parliament should determine the strategic and operational guidance for the InvestEU Fund. (47) The Commission should assess the compatibility of financing and investment operations submitted by the implementing partners with all Union law and policies. The decisions on financing and investment operations should ultimately be taken by an implementing partner. (48) The Investment Committee composed of independent experts should reach a conclusion on the granting of support from the EU guarantee to financing and investment operations fulfilling the eligibility criteria of the InvestEU Fund, thereby providing external expertise in investment assessments in relation to projects. The Investment Committee should have different configurations to cover different policy areas and sectors in the best way possible. (49) An independent secretariat hosted by the Commission and answerable to the chairperson of the Investment Committee should assist the Investment Committee. (50) In selecting implementing partners for the deployment of the InvestEU Fund, the Commission should consider their ability to fulfil the objectives of the InvestEU Fund and to contribute their own resources, in order to ensure adequate geographical coverage and diversification, to crowd in private investors and to provide sufficient risk diversification and solutions to address market failures and suboptimal investment situations. Given its role under the Treaties, its capacity to operate in all Member States and the existing experience under the current financial instruments and the EFSI, the EIB Group should remain a privileged implementing partner under the InvestEU Fund’s EU compartment. In addition to the EIB Group, national promotional banks and institutions should be able to offer a complementary financial product range, given that their experience and capabilities at national and regional level could be beneficial for the maximisation of the impact of public funds on the whole territory of the Union, and for ensuring a fair geographical balance of projects. The InvestEU Programme should be implemented in such a way as to promote a level playing field for smaller and younger promotional banks and institutions. Moreover, it should be possible for other international financial institutions to become implementing partners, in particular when they present a comparative advantage in terms of specific expertise and experience in certain Member States and when they present a Union majority of shareholding. It should also be possible for other entities fulfilling the criteria laid down in the Financial Regulation to become implementing partners. (51) With a view to promoting improved geographic diversification, investment platforms may be established to combine the efforts and expertise of implementing partners with other national promotional banks and institutions that have limited experience in the use of financial instruments. Such structures should be encouraged, including with available support from the InvestEU Advisory Hub. It is appropriate to bring together co-investors, public authorities, experts, education, training and research institutions, relevant social partners and representatives of the civil society and other relevant actors at Union, at national and regional levels to promote the use of investment platforms in relevant sectors. (52) The EU guarantee under the Member State compartment should be allocated to any implementing partner eligible in accordance with point (c) of Article 62(1) of the Financial Regulation, including national or regional promotional banks or institutions, the EIB, the EIF and other international financial institutions. When selecting implementing partners under the Member State compartment, the Commission should take into account the proposals made by each Member State, as reflected in the contribution agreement. In accordance with Article 154 of the Financial Regulation, the Commission is to carry out an assessment of the rules and procedures of the implementing partner to ascertain that they provide a level of protection of the financial interest of the Union equivalent to the one provided by the Commission. (53) Financing and investment operations should ultimately be decided by the implementing partner in its own name, implemented in accordance with its internal rules, policies and procedures, and accounted for in its own financial statements or, where applicable, disclosed in the notes to the financial statements. Therefore, the Commission should exclusively account for any financial liability arising from the EU guarantee and should disclose the maximum guarantee amount, including all relevant information concerning the guarantee provided. (54) Where appropriate, the InvestEU Fund should allow for the smooth, seamless and efficient blending of grants, financial instruments or both, funded by the Union budget or by other funds, such as the EU Emissions Trading System (ETS) Innovation Fund with the EU guarantee in situations where this is necessary to best underpin investments to address particular market failures or suboptimal investment situations. (55) Projects submitted by implementing partners for support under the InvestEU Programme, which include blending support from the InvestEU Fund with support from other Union programmes, should as a whole be consistent with the objectives and eligibility criteria of the relevant other Union programmes. The use of the EU guarantee should be decided under the InvestEU Programme. (56) The InvestEU Advisory Hub should support the development of a robust pipeline of investment projects in each policy window through advisory initiatives that are implemented by the EIB Group or other advisory partners, or are implemented directly by the Commission. The InvestEU Advisory Hub should promote geographic diversification with a view to contributing to the Union objectives of economic, social, and territorial cohesion and reducing regional disparities. The InvestEU Advisory Hub should pay particular attention to the aggregation of small-sized projects into larger portfolios. The Commission, the EIB Group and the other advisory partners should cooperate closely with a view to ensuring efficiency, synergies and effective geographic coverage of support across the Union, taking into account the expertise and local capacity of local implementing partners, as well as the European Investment Advisory Hub established under Regulation (EU) 2015/1017 of the European Parliament and of the Council (15). The findings of the European Court of Auditors’ Special Report No 12/2020 ‘The European Investment Advisory Hub: Launched to boost investment in the EU, the Hub’s impact remains limited’ (16) should be carefully considered in order to maximise the InvestEU Advisory Hub’s effectiveness and impact. The InvestEU Advisory Hub should provide a central entry point for project development assistance delivered under the InvestEU Advisory Hub to public authorities and for project promoters. (57) The InvestEU Advisory Hub should be established by the Commission with the EIB Group as the main partner, building on the experience acquired through the European Investment Advisory Hub. The Commission should be responsible for the policy steer of the InvestEU Advisory Hub and for the management of the central entry point. The EIB Group should deliver advisory initiatives under the policy windows. In addition, the EIB Group should provide operational services to the Commission, including by providing input to the strategic and policy guidelines regarding advisory initiatives, mapping existing and emerging advisory initiatives, assessing advisory needs and advising the Commission on optimal ways to address these needs through existing or new advisory initiatives. (58) In order to ensure a wide geographic outreach of the advisory services across the Union and to successfully leverage local knowledge about the InvestEU Fund, a local presence of the InvestEU Advisory Hub should be ensured, where needed, taking into account existing support schemes and the presence of local partners, with a view to providing tangible, proactive, tailor-made assistance on the ground. In order to facilitate the provision of advisory support at local level and to ensure efficiency, synergies and effective geographic coverage of support across the Union, the InvestEU Advisory Hub should cooperate with national promotional banks and institutions, and should benefit from and make use of their expertise. (59) The InvestEU Advisory Hub should provide advisory support to small-sized projects and projects for start-ups, especially when start-ups seek to protect their research and innovation investments by obtaining intellectual property titles, such as patents, taking into account the existence of other services able to cover such actions and seeking synergies with those services. (60) In the context of the InvestEU Fund, there is a need to provide support for project development and capacity building to develop the organisational capacities and market development activities needed to originate quality projects. Such support should also target financial intermediaries that are key to help SMEs access financing and realise their full potential. Moreover, the aim of the advisory support is to create the conditions for the expansion of the potential number of eligible recipients in nascent market segments, in particular where the small size of individual projects considerably raises the transaction cost at the project level, such as for the social finance ecosystem, including philanthropic organisations, or for the cultural and creative sectors. The capacity-building support should be complementary and in addition to actions taken under other Union programmes that cover specific policy areas. An effort should also be made to support the capacity building of potential project promoters, in particular local organisations and authorities. (61) The InvestEU Portal should be established to provide for an easily accessible and user-friendly project database to promote visibility of investment projects searching for financing with enhanced focus on the provision of a possible pipeline of investment projects, compatible with Union law and policies, to the implementing partners. (62) In accordance with Council Regulation (EU) 2020/2094 (17) and within the limits of resources allocated therein, recovery and resilience measures under the InvestEU Programme should be carried out to address the unprecedented impact of the COVID-19 crisis. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation (EU) 2020/2094. (63) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (18), the InvestEU Programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements, while avoiding an administrative burden, in particular on Member States, and overregulation. Those requirements, where appropriate, should include measurable indicators, as a basis for evaluating the effects of the InvestEU Programme on the ground. (64) A solid monitoring framework that is based on output, outcome and impact indicators should be implemented to track progress towards the Union’s objectives. In order to ensure accountability to the Union’s citizens, the Commission should report annually to the European Parliament and the Council on the progress, impact and operations of the InvestEU Programme. (65) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 of the Treaty on the Functioning of the European Union (TFEU) apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes, indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (66) The Financial Regulation applies to the InvestEU Programme. It lays down rules on the implementation of the Union budget, including the rules on budgetary guarantees. (67) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (19) and Council Regulations (EC, Euratom) No 2988/95 (20), (Euratom, EC) No 2185/96 (21) and (EU) 2017/1939 (22), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor’s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (23). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (68) Third countries which are members of the European Economic Area (EEA) may participate in Union programmes in the framework of the cooperation established under the Agreement on the European Economic Area (24), which provides for the implementation of the programmes on the basis of a decision adopted under that Agreement. Third countries may also participate on the basis of other legal instruments. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. (69) Pursuant to Council Decision 2013/755/EU (25), individuals and entities established in overseas countries or territories are eligible for funding subject to the rules and objectives of the InvestEU Programme and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. (70) In order to supplement the non-essential elements of this Regulation with investment guidelines and with a scoreboard of indicators, to facilitate the prompt and flexible adaptation of the performance indicators and to adjust the provisioning rate, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of drawing-up investment guidelines for the financing and investment operations under different policy windows, of the scoreboard, of the amendment of Annex III to this Regulation to review or complement the indicators and of the adjustment of the provisioning rate. In line with the principle of proportionality, such investment guidelines should include adequate provisions to avoid undue administrative burden. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (71) Financing and investment operations signed or entered into by an implementing partner during the period from 1 January 2021 until the signature of their respective guarantee agreements should be eligible for the EU guarantee provided that such operations are indicated in the guarantee agreement, pass the policy check or receive a favourable opinion within the framework of the procedure provided for in Article 19 of Protocol No 5 on the Statute of the European Investment Bank annexed to the Treaty on European Union (TEU) and the TFEU (the EIB Statute), and are in both cases approved by the Investment Committee. (72) In order to optimise the use of budgetary resources, a combination of relevant portfolios of financial instruments established under the 2014-2020 Multiannual Financial Framework and the EU guarantee under Regulation (EU) 2015/1017 with the EU guarantee under this Regulation should be possible. The increased risk bearing capacity established by such combination should enhance the efficiency of the EU guarantee under this Regulation and allow for more support to final recipients. The modalities of the combination should be defined in the guarantee agreement between the Commission and the EIB or the EIF. The conditions of the combination should be consistent with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (26). (73) Since the objectives of this Regulation, namely to address Union-wide and Member State specific market failures and suboptimal investment situations and provide for Union-wide market testing of innovative financial products designed to address new or complex market failures or suboptimal investment situations and of systems to spread such products, cannot be sufficiently achieved by the Member States, but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (74) In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the multi-annual financial framework 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021, HAVE ADOPTED THIS REGULATION: CHAPTER I General provisions Article 1 Subject matter This Regulation establishes the InvestEU Fund, which shall provide for an EU guarantee to support financing and investment operations carried out by the implementing partners that contribute to objectives of the Union’s internal policies. This Regulation also establishes an advisory support mechanism to provide support for the development of investable projects and access to financing and to provide related capacity building assistance (the ‘InvestEU Advisory Hub’). It further establishes a database granting visibility to projects for which project promoters seek financing and which provides investors with information about investment opportunities (the ‘InvestEU Portal’). This Regulation establishes the objectives of the InvestEU Programme, its budget and the amount of the EU guarantee for the period 2021 to 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘InvestEU Programme’ means the InvestEU Fund, the InvestEU Advisory Hub, the InvestEU Portal and blending operations, collectively; (2) ‘EU guarantee’ means an overall irrevocable, unconditional and on demand budgetary guarantee provided by the Union budget under which the budgetary guarantees in accordance with Article 219(1) of the Financial Regulation take effect through the entry into force of individual guarantee agreements with implementing partners; (3) ‘policy window’ means a targeted area for support by the EU guarantee as laid down in Article 8(1); (4) ‘compartment’ means a part of the EU guarantee defined in terms of the origin of the resources backing it; (5) ‘blending operation’ means an operation supported by the Union budget that combines non-repayable forms of support, repayable forms of support, or both, from the Union budget with repayable forms of support from development or other public finance institutions, or from commercial finance institutions and investors; for the purposes of this definition, Union programmes financed from sources other than the Union budget, such as the EU ETS Innovation Fund, may be assimilated to Union programmes financed by the Union budget; (6) ‘EIB Group’ means the EIB, its subsidiaries and other entities established in accordance with Article 28(1) of Protocol No 5 on the Statute of the European Investment Bank annexed to the TEU and the TFEU (the EIB Statute); (7) ‘financial contribution’ means a contribution from an implementing partner in the form of own risk-taking capacity that is provided on a pari passu basis with the EU guarantee or in another form that allows an efficient implementation of the InvestEU Programme while ensuring appropriate alignment of interest; (8) ‘contribution agreement’ means a legal instrument whereby the Commission and one or more Member States specify the conditions of the EU guarantee under the Member State compartment, as laid down in Article 10; (9) ‘financial product’ means a financial mechanism or arrangement under the terms of which the implementing partner provides direct or intermediated financing to final recipients using any of the types of financing referred to in Article 16; (10) ‘financing and investment operations’ or ‘financing or investment operations’ means operations to provide finance directly or indirectly to final recipients through financial products, carried out by an implementing partner in its own name, provided by the implementing partner in accordance with its internal rules, policies and procedures and accounted for in the implementing partner’s financial statements or, where applicable, disclosed in the notes to those financial statements; (11) ‘funds under shared management’ means funds that provide for the possibility of allocating a portion of those funds to the provisioning for a budgetary guarantee under the Member State compartment of the InvestEU Fund, namely the European Regional Development Fund (ERDF) and the Cohesion Fund to be established by a Regulation of the European Parliament and of the Council on the European Regional Development Fund and on the Cohesion Fund for the years 2021-2027, the European Social Fund Plus (ESF+) to be established by a Regulation of the European Parliament and of the Council on the European Social Fund Plus (ESF+) (the ‘ESF+ Regulation for 2021-2027’), the European Maritime, Fisheries and Aquaculture Fund (EMFAF) to be established by a Regulation of the European Parliament and of the Council on the European Maritime, Fisheries and Aquaculture Fund and repealing Regulation (EU) No 508/2014 and the European Agriculture Fund for Rural Development (EAFRD) to be established by a Regulation of the European Parliament and of the Council establishing rules on support for strategic plans to be drawn up by Member States under the Common agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing Regulation (EU) No 1305/2013 of the European Parliament and of the Council and Regulation (EU) No 1307/2013 of the European Parliament and of the Council (the ‘CAP Strategic Plans Regulation’); (12) ‘guarantee agreement’ means a legal instrument whereby the Commission and an implementing partner specify the conditions for proposing financing and investment operations in order for them to be granted the benefit of the EU guarantee, for providing the EU guarantee for those operations and for implementing them in accordance with this Regulation; (13) ‘implementing partner’ means an eligible counterpart such as a financial institution or other financial intermediary with whom the Commission has concluded a guarantee agreement; (14) ‘important project of common European interest’ means a project that fulfils all the criteria laid down in the Commission Communication on Criteria for the analysis of the compatibility with the internal market of State aid to promote the execution of important projects of common European interest or any subsequent revision of that Communication; (15) ‘advisory agreement’ means a legal instrument whereby the Commission and the advisory partner specify the conditions for the implementation of the InvestEU Advisory Hub; (16) ‘advisory initiative’ means technical assistance and advisory services that support investment, including capacity building activities, provided by advisory partners, by external service providers contracted by the Commission, or by executive agencies; (17) ‘advisory partner’ means an eligible counterpart such as a financial institution or other entity with whom the Commission has concluded an advisory agreement for the purpose of implementing one or more advisory initiatives, other than advisory initiatives implemented through external service providers contracted by the Commission or through executive agencies; (18) ‘investment platform’ means a special purpose vehicle, managed account, contract-based co-financing or risk-sharing arrangement or an arrangement established by any other means by which entities channel a financial contribution in order to finance a number of investment projects, and which may include: (a) a national or sub-national platform that groups together several investment projects on the territory of a given Member State; (b) a cross-border, multi-country, regional or macro-regional platform that groups together partners from several Member States, regions or third countries interested in investment projects in a given geographic area; (c) a thematic platform that groups together investment projects in a given sector; (19) ‘microfinance’ means microfinance as defined in the relevant provisions of the ESF+ Regulation for 2021-2027; (20) ‘national promotional bank or institution’ means a legal entity that carries out financial activities on a professional basis which has been given mandate by a Member State or a Member State’s entity at central, regional or local level to carry out development or promotional activities; (21) ‘small and medium-sized enterprise’ or ‘SME’ means a micro, small or medium-sized enterprise within the meaning of the Annex to Commission Recommendation 2003/361/EC (27); (22) ‘small mid-cap company’ means an entity that is not an SME and that employs up to 499 employees; (23) ‘social enterprise’ means a social enterprise as defined in the relevant provisions of the ESF+ Regulation for 2021-2027. Article 3 Objectives of the InvestEU Programme 1. The general objective of the InvestEU Programme is to support the policy objectives of the Union by means of financing and investment operations that contribute to: (a) the competitiveness of the Union, including research, innovation and digitisation; (b) growth and employment in the Union economy, the sustainability of the Union economy and its environmental and climate dimension contributing to the achievement of the SDGs and the objectives of the Paris Agreement and to the creation of high-quality jobs; (c) the social resilience, inclusiveness and innovativeness of the Union; (d) the promotion of scientific and technological advances, of culture, education and training; (e) the integration of Union capital markets and the strengthening of the internal market, including solutions to address the fragmentation of Union capital markets, diversify sources of financing for Union enterprises and promote sustainable finance; (f) the promotion of economic, social and territorial cohesion; or (g) the sustainable and inclusive recovery of the Union economy after the COVID-19 crisis, including by providing capital support for SMEs that were negatively affected by the COVID-19 crisis and were not already in difficulty in State aid terms at the end of 2019, upholding and strengthening existing strategic value chains of tangible or intangible assets, developing new ones, and maintaining and reinforcing activities of strategic importance to the Union, including important projects of common European interest, in relation to critical infrastructure, whether physical or virtual, transformative technologies, game-changing innovations and inputs to businesses and consumers and supporting a sustainable transition. 2. The InvestEU Programme has the following specific objectives: (a) supporting financing and investment operations related to sustainable infrastructure in the areas referred to in point (a) of Article 8(1); (b) supporting financing and investment operations related to research, innovation and digitisation, including support for the scaling up of innovative companies and the rolling out of technologies to market, in the areas referred to in point (b) of Article 8(1); (c) increasing the access to and the availability of finance for SMEs and for small mid-cap companies and to enhance the global competitiveness of such SMEs; (d) increasing access to and the availability of microfinance and finance for social enterprises, to support financing and investment operations related to social investment, competences and skills, and to develop and consolidate social investment markets, in the areas referred to in point (d) of Article 8(1). Article 4 Budget and amount of the EU guarantee 1. The EU guarantee for the purposes of the EU compartment referred to in point (a) of Article 9(1) shall be EUR 26 152 310 073 in current prices. It shall be provisioned at the rate of 40 %. The amount referred to in point (a) of the first subparagraph of Article 35(3) shall be also taken into account for contributing to the provisioning resulting from that provisioning rate. An additional amount of the EU guarantee may be provided for the purposes of the Member State compartment referred to in point (b) of Article 9(1) of this Regulation, subject to the allocation by Member States, pursuant to the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in a Regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the instrument for financial support for border management and visa (the ‘Common Provisions Regulation for 2021-2027’) and the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation, of the corresponding amounts. An additional amount of the EU guarantee may also be provided in the form of cash or guarantee by Member States for the purposes of the Member State compartment. The amount provided in cash shall constitute an external assigned revenue in accordance with the second sentence of Article 21(5) of the Financial Regulation. The contributions from third countries referred to in Article 5 of this Regulation shall also increase the EU guarantee referred to in the first subparagraph, providing a provisioning in cash in full in accordance with Article 218(2) of the Financial Regulation. 2. An amount of EUR 14 825 000 000 in current prices of the amount referred to in the first subparagraph of paragraph 1 of this Article shall be allocated for operations implementing measures referred to in Article 1 of Regulation (EU) 2020/2094 for the objectives referred to in Article 3(2) of this Regulation. An amount of EUR 11 327 310 073 in current prices of the amount referred to in the first subparagraph of paragraph 1 of this Article shall be allocated for the objectives referred to in Article 3(2). The amounts referred to in the first subparagraph of this paragraph shall only be available as of the date referred to in Article 3(3) of Regulation (EU) 2020/2094. The indicative distribution of the EU guarantee for the purposes of the EU compartment is set out in Annex I to this Regulation. Where appropriate, the Commission may depart from the amounts referred to in Annex I by up to 15 % for each objective referred to in points (a) to (d) of Article 3(2). The Commission shall inform the European Parliament and the Council of any such departure. 3. The financial envelope for the implementation of the measures provided in Chapters VI and VII shall be EUR 430 000 000 in current prices. 4. The amount referred to in paragraph 3 may also be used for technical and administrative assistance for the implementation of the InvestEU Programme, such as preparatory, monitoring, control, audit and evaluation activities, including for corporate information technology systems. Article 5 Third countries associated to the InvestEU Fund The EU compartment of the InvestEU Fund referred to in point (a) of Article 9(1) of this Regulation and each of the policy windows referred to in Article 8(1) of this Regulation may receive contributions from the following third countries for the purpose of participation in certain financial products pursuant to Article 218(2) of the Financial Regulation: (a) members of the European Free Trade Association (EFTA) which are members of the EEA, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country to any Union programme, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes; (ii) lays down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes, and their administrative costs; (iii) does not confer on the third country any decision-making power in respect of the Union programme; (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests. The contributions referred to in point (d)(ii) of the first paragraph of this Article shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. Article 6 Implementation and forms of Union funding 1. The EU guarantee shall be implemented in indirect management with bodies referred to in points (c)(ii), (c)(iii), (c)(v) and (c)(vi) of Article 62(1) of the Financial Regulation. Other forms of Union funding under this Regulation shall be implemented in direct or indirect management in accordance with the Financial Regulation, including grants implemented in accordance with Title VIII of the Financial Regulation and blending operations implemented in accordance with this Article as smoothly as possible, in a manner that ensures efficient and coherent support for Union policies. 2. Financing and investment operations covered by the EU guarantee which form part of the blending operation combining support under this Regulation with support provided under one or more other Union programmes or covered by the EU ETS Innovation Fund shall: (a) be consistent with the policy objectives and comply with the eligibility criteria set out in the rules of the Union programme under which the support is decided; (b) comply with this Regulation. 3. Blending operations that include a financial instrument that is fully financed by other Union programmes or by the EU ETS Innovation Fund without the use of the EU guarantee under this Regulation shall be consistent with the policy objectives and comply with the eligibility criteria set out in the rules of the Union programme under which the support is provided. 4. In accordance with paragraph 2 of this Article, the non-repayable forms of support and financial instruments from the Union budget forming part of the blending operation referred to in paragraphs 2 and 3 of this Article shall be decided under the rules of the relevant Union programme and shall be implemented within the blending operation in accordance with this Regulation and with Title X of the Financial Regulation. The reporting relating to such blending operations shall also cover their consistency with the policy objectives and eligibility criteria set out in the rules of the Union programme under which the support is decided as well as their compliance with this Regulation. Article 7 Combination of portfolios 1. Support from the EU guarantee under this Regulation, Union support provided through the financial instruments established by the programmes in the programming period 2014-2020 and Union support from the EU guarantee established by Regulation (EU) 2015/1017 may be combined in financial products to be implemented by the EIB or the EIF under this Regulation. 2. By way of derogation from Article 19(2) and the second subparagraph of Article 16(1), the EU guarantee under this Regulation may also cover losses referred to in Article 19(2) in relation to the entire portfolio of financing and investment operations supported by the financial products referred to in paragraph 1 of this Article. Notwithstanding the objectives of the financial instruments referred to in paragraph 1, the provisions made to cover the financial liabilities arising from financial instruments referred to in paragraph 1 may be used to cover losses in relation to the entire portfolio of financing and investment operations supported by the financial products referred to in paragraph 1. 3. Losses, revenues and repayments from financial products as referred to in paragraph 1, as well as potential recoveries, shall be attributed pro rata between the financial instruments and EU guarantees referred to in that paragraph providing the combined Union support to that financial product. 4. The terms and conditions of the financial products referred to in paragraph 1 of this Article, including the respective pro rata shares of losses, revenues, repayments and recoveries, shall be set out in the guarantee agreement referred to in Article 17. CHAPTER II InvestEU Fund Article 8 Policy windows 1. The InvestEU Fund shall operate through the following four policy windows that shall address market failures or suboptimal investment situations within their specific scope: (a) a sustainable infrastructure policy window which comprises sustainable investment in the areas of transport, including multimodal transport, road safety, including in accordance with the Union objective of eliminating fatal road accidents and serious injuries by 2050, the renewal and maintenance of rail and road infrastructure, energy, in particular renewable energy, energy efficiency in accordance with the 2030 energy framework, buildings renovation projects focused on energy savings and the integration of buildings into a connected energy, storage, digital and transport systems, improving interconnection levels, digital connectivity and access, including in rural areas, supply and processing of raw materials, space, oceans, water, including inland waterways, waste management in accordance with the waste hierarchy and the circular economy, nature and other environment infrastructure, cultural heritage, tourism, equipment, mobile assets and the deployment of innovative technologies that contribute to the environmental or climate resilience or social sustainability objectives of the Union and that meet the environmental or social sustainability standards of the Union; (b) a research, innovation and digitisation policy window which comprises research, product development and innovation activities, the transfer of technologies and research results to the market to support market enablers and cooperation between enterprises, the demonstration and deployment of innovative solutions and support for the scaling up of innovative companies, as well as digitisation of Union industry; (c) an SME policy window which comprises access to and the availability of finance primarily for SMEs, including for innovative SMEs and SMEs operating in the cultural and creative sectors, as well as for small mid-cap companies; (d) a social investment and skills policy window, which comprises microfinance, social enterprise finance, social economy and measures to promote gender equality, skills, education, training and related services, social infrastructure, including health and educational infrastructure and social and student housing, social innovation, health and long-term care, inclusion and accessibility, cultural and creative activities with a social goal, and the integration of vulnerable people, including third country nationals. 2. A just transition scheme shall be established horizontally across all policy windows. That scheme shall comprise investments that address social, economic and environmental challenges deriving from the transition process towards the achievement of the Union’s 2030 climate target and its target of achieving climate neutrality by 2050, as well as benefit territories identified in a just transition plan prepared by a Member State in accordance with the relevant provisions of the Just Transition Fund Regulation. 3. All policy windows may include strategic investments including important projects of common European interest to support final recipients whose activities are of strategic importance to the Union, in particular in view of the green and digital transitions, of enhanced resilience and of strengthening strategic value chains. In the case of strategic investments in defence and space sectors and in cybersecurity, as well as in specific types of projects with actual and direct security implications in critical sectors, the investment guidelines adopted in accordance with paragraph 9 of this Article (the ‘investment guidelines’) shall set out limitations with respect to final recipients controlled by a third country or third country entities and final recipients having their executive management outside the Union with a view to protecting the security of the Union and its Member States. Those limitations shall be set out in line with the principles concerning eligible entities set out in the relevant provisions of a Regulation of the European Parliament and of the Council establishing the European Defence Fund and repealing Regulation (EU) 2018/1092 and in the relevant provisions of a Regulation of the European Parliament and of the Council establishing the Union Space Programme and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013, (EU) No 377/2014 and Decision No 541/2014/EU. The investment guidelines shall set out any necessary requirements relating to the control and executive management of final recipients for other areas, and to the control of intermediaries, in the light of any applicable public order or security considerations. Taking account of those requirements, the Steering Board shall set out any necessary additional requirements. 4. Where a financing or investment operation proposed to the Investment Committee falls under more than one policy window, it shall be attributed to the policy window under which its main objective or the main objective of most of its sub-projects falls, unless the investment guidelines provide otherwise. 5. Financing and investment operations shall be screened to determine whether they have an environmental, climate or social impact. If those operations have such an impact they shall be subject to climate, environmental and social sustainability proofing with a view to minimising detrimental impacts and to maximising benefits to the climate, environment and social dimensions. For that purpose, project promoters that request financing shall provide adequate information based on the guidance referred to in paragraph 6. Projects below a certain size specified in the guidance shall be excluded from the proofing. Projects that are inconsistent with the climate objectives shall not be eligible for support under this Regulation. In the event that the implementing partner concludes that no sustainability proofing is to be carried out, it shall provide a justification to the Investment Committee. 6. The Commission shall develop sustainability guidance that, in accordance with Union environmental and social objectives and standards and, taking appropriate account of the principle of ‘do no significant harm’ allows for: (a) as regards adaptation, ensuring resilience to the potential adverse impacts of climate change through a climate vulnerability and risk assessment, including through relevant adaptation measures, and, as regards mitigation, integrating the cost of greenhouse gas emissions and the positive effects of climate mitigation measures in the cost-benefit analysis; (b) accounting for the consolidated impact of projects in terms of the principal components of natural capital, namely air, water, land and biodiversity; (c) estimating the social impact of projects, including on gender equality, on the social inclusion of certain areas or populations and on the economic development of areas and sectors affected by structural challenges such as the need to decarbonise the economy; (d) identifying projects that are inconsistent with the achievement of climate objectives; (e) providing implementing partners with guidance for the purpose of the screening provided for under paragraph 5. 7. Implementing partners shall provide the information necessary to allow the tracking of investment that contributes to meeting the Union objectives on climate and environment, on the basis of guidance to be provided by the Commission. 8. Implementing partners shall apply a target of at least 60 % of the investment under the sustainable infrastructure policy window contributing to meeting the Union objectives on climate and environment. The Commission, together with implementing partners, shall seek to ensure that the part of the EU guarantee used for the sustainable infrastructure policy window is distributed with the aim of achieving a balance between the different areas referred to in point (a) of paragraph 1. 9. The Commission is empowered to adopt delegated acts in accordance with Article 34 in order to supplement this Regulation by defining the investment guidelines for each of the policy windows. The investment guidelines shall also set out the arrangements for the implementation of the just transition scheme, as referred to in paragraph 2 of this Article. The investment guidelines shall be prepared in close dialogue with the EIB Group and other potential implementing partners. 10. For strategic financing and investment operations in defence and space sectors and in cybersecurity, the investment guidelines may set out limitations with respect to transfer and licensing of intellectual property rights to critical technologies and technologies instrumental to safeguarding the security of the Union and its Member States while respecting Member State competence within export control. 11. The Commission shall make the information on the application and interpretation of the investment guidelines available to the implementing partners, the Investment Committee and the advisory partners. Article 9 Compartments 1. The policy windows referred to in Article 8(1) shall consist of an EU compartment and a Member State compartment. Those compartments shall address market failures or suboptimal investment situations as follows: (a) the EU compartment shall address any of the following situations: (i) market failures or suboptimal investment situations related to Union policy priorities; (ii) Union-wide or Member State specific market failures or suboptimal investment situations; or (iii) market failures or suboptimal investment situations, which require the development of innovative financial solutions and market structures, in particular new or complex market failures or suboptimal investment situations; (b) the Member State compartment shall address specific market failures or suboptimal investment situations in one or several regions or Member States to deliver the policy objectives of the contributing funds under shared management or of the additional amount provided by a Member State under the third subparagraph of Article 4(1), in particular to strengthen economic, social and territorial cohesion in the Union by addressing imbalances between its regions. 2. Where appropriate, the compartments referred to in paragraph 1 shall be used in a complementary manner to support a given financing or investment operation, including by combining support from both compartments. Article 10 Specific provisions applicable to the Member State compartment 1. Amounts allocated by a Member State on a voluntary basis pursuant to the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 or to the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation or amounts provided in cash in accordance with the third subparagraph of Article 4(1) of this Regulation shall be used for the provisioning for the part of the EU guarantee under the Member State compartment covering financing and investment operations in the Member State concerned or for the possible contribution to the InvestEU Advisory Hub. Those amounts shall be used to contribute to the achievement of the policy objectives specified in the Partnership Agreement referred to in the provisions on the preparation and submission of the Partnership Agreement laid down in the Common Provisions Regulation for 2021-2027, in the programmes or in the CAP Strategic Plan which contribute to the InvestEU Programme, in order to implement relevant measures set out in the recovery and resilience plan established under Regulation (EU) 2021/241 or, in other cases, for the purposes laid down in the contribution agreement, depending on the origin of the amount contributed. 2. The establishment of the part of the EU guarantee under the Member State compartment shall be subject to the conclusion of a contribution agreement between a Member State and the Commission. The fourth subparagraph of this paragraph and paragraph 5 of this Article shall not apply to the additional amount provided by a Member State under the third subparagraph of Article 4(1). The provisions in this Article relating to amounts allocated pursuant to the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 or to the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation are not applicable to a contribution agreement concerning an additional amount by a Member State, referred to in the third subparagraph of Article 4(1) of this Regulation. The Member State and the Commission shall conclude a contribution agreement or an amendment to it within four months following the Commission Decision approving the Partnership Agreement pursuant to the provisions on the approval of the Partnership Agreement laid down in the Common Provisions Regulation for 2021-2027 or the CAP Strategic Plan under the CAP Strategic Plans Regulation or simultaneously to the Commission Decision amending a programme in accordance with the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 or a CAP Strategic Plan in accordance with the provisions on the amendment to the CAP Strategic Plan laid down in the CAP Strategic Plans Regulation. Two or more Member States may conclude a joint contribution agreement with the Commission. By way of derogation from Article 211(1) of the Financial Regulation, the provisioning rate of the EU guarantee under the Member State compartment shall be set at 40 % and may be adjusted downwards or upwards in each contribution agreement to take account of the risks attached to the financial products intended to be used. 3. The contribution agreement shall at least contain the following elements: (a) the overall amount of the part of the EU guarantee under the Member State compartment pertaining to the Member State concerned, its provisioning rate, the amount of the contribution from funds under shared management or provided in accordance with the third subparagraph of Article 4(1), the constitution phase of the provisioning and the amount of the resulting contingent liability to be covered by a back-to-back guarantee provided by the Member State concerned; (b) the Member State strategy, consisting of the financial products and their minimum leverage, the geographical coverage, including regional coverage if necessary, types of projects, the investment period and, where applicable, the categories of final recipients and of eligible intermediaries; (c) the potential implementing partner or partners proposed in accordance with fourth subparagraph of Article 15(1) and the obligation of the Commission to inform the Member State concerned of the implementing partner or partners selected; (d) any contribution from funds under shared management or from amounts provided in accordance with the third subparagraph of Article 4(1) to the InvestEU Advisory Hub; (e) the obligations to provide annual reports to the Member State, including reporting on the relevant indicators related to the policy objectives covered in the Partnership Agreement, programme, CAP Strategic Plan or in the recovery and resilience plans and referred to in the contribution agreement; (f) provisions on the remuneration for the part of the EU guarantee under the Member State compartment; (g) any combination with resources under the EU compartment in accordance with Article 9(2), including in a layered structure to achieve better risk coverage. 4. The contribution agreements shall be implemented by the Commission through guarantee agreements concluded with implementing partners in accordance with Article 17 and advisory agreements concluded with advisory partners in accordance with the second subparagraph of Article 25(1). Where no guarantee agreement has been concluded within nine months from the conclusion of the contribution agreement, the contribution agreement shall be terminated or prolonged by mutual agreement. Where the amount of a contribution agreement has not been fully committed under one or more guarantee agreements within nine months from the conclusion of the contribution agreement, that amount shall be amended accordingly. The unused amount of provisioning attributable to amounts allocated by Member States pursuant to the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 or to the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation shall be re-used in accordance with those Regulations. The unused amount of provisioning attributable to amounts allocated by a Member State under the third subparagraph of Article 4(1) of this Regulation shall be paid back to the Member State. Where a guarantee agreement has not been duly implemented within the period specified in the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 or in the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation, or, in the case of a guarantee agreement related to amounts provided in accordance with the third subparagraph of Article 4(1) of this Regulation, in the relevant contribution agreement, the contribution agreement shall be amended. The unused amount of provisioning attributable to amounts allocated by Member States pursuant to the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 or to the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation shall be re-used in accordance with those Regulations. The unused amount of provisioning attributable to amounts allocated by a Member State under the third subparagraph of Article 4(1) of this Regulation shall be paid back to the Member State. 5. The following rules shall apply to the provisioning for the part of the EU guarantee under the Member State compartment established by a contribution agreement: (a) after the constitution phase referred to in point (a) of paragraph 3 of this Article, any annual surplus of provisions, calculated by comparing the amount of provisions required by the provisioning rate set in the contribution agreement and the actual amount of provisions, shall be re-used pursuant to the provisions on the use of the ERDF, the ESF+, the Cohesion Fund and the EMFAF delivered through the InvestEU Programme laid down in the Common Provisions Regulation for 2021-2027 and to the provisions on the use of the EAFRD delivered through the InvestEU Programme laid down in the CAP Strategic Plans Regulation; (b) by way of derogation from Article 213(4) of the Financial Regulation, after the constitution phase referred to in point (a) of paragraph 3 of this Article, the provisioning shall not give rise to annual replenishments during the availability of that part of the EU guarantee under the Member State compartment; (c) the Commission shall immediately inform the Member State where the level of provisions for that part of the EU guarantee falls below 20 % of the initial provisioning as a result of calls on that part of the EU guarantee under the Member State compartment; (d) if the level of provisions for that part of the EU guarantee under the Member State compartment reaches 10 % of the initial provisioning, the Member State concerned shall provide up to 5 % of the initial provisioning to the common provisioning fund referred to in Article 212 of the Financial Regulation upon request by the Commission. 6. In relation to amounts referred to in the third subparagraph of Article 4(1), the management of the annual surpluses and replenishments after the constitution phase shall be defined in the contribution agreement. CHAPTER III Partnership between the Commission and the EIB Group Article 11 Scope of the partnership 1. The Commission and the EIB Group shall form a partnership under this Regulation with the objective of supporting the implementation of the InvestEU Programme and fostering consistency, inclusivity, additionality, and efficient deployment. In accordance with this Regulation and as further specified in the agreements referred to in paragraph 3, the EIB Group: (a) shall implement the portion of the EU guarantee specified in Article 13(4); (b) shall support the implementation of the EU compartment of the InvestEU Fund, and, where applicable, the Member State compartment, in particular by: (i) contributing, together with potential implementing partners, to the investment guidelines in accordance with Article 8(9), contributing to the design of the Scoreboard in accordance with Article 22 and contributing to other documents that set out the operational guidance of the InvestEU Fund; (ii) defining, together with the Commission and potential implementing partners, the risk methodology and risk mapping system that relate to the financing and investment operations of the implementing partners in order to allow such operations to be assessed on a common rating scale; (iii) at the request of the Commission and in agreement with the potential implementing partner concerned, carrying out an assessment of the systems of that potential implementing partner and providing targeted technical advice on those systems, where and to the extent required by the conclusions of the audit of the pillar assessment in view of the implementation of the financial products envisaged by that potential implementing partner; (iv) providing a non-binding opinion on the banking-related aspects, in particular on the financial risk and financial terms related to the portion of the EU guarantee to be allocated to the implementing partner, other than to the EIB Group, as defined in the guarantee agreement to be concluded with that implementing partner; (v) carrying out simulations and projections of the financial risk and remuneration of the aggregate portfolio on the basis of assumptions agreed with the Commission; (vi) measuring the financial risk of the aggregate portfolio and providing financial reports on the aggregate portfolio; and (vii) providing restructuring and recovery services as set out in the agreement referred to in point (b) of paragraph 3 of this Article to the Commission at the request of the Commission and in agreement with the implementing partner in accordance with point (g) of Article 17(2) where that implementing partner is no longer responsible for pursuing restructuring and recovery activities under the relevant guarantee agreement; (c) may provide capacity building as referred to in point (h) of Article 25(2) to a national promotional bank or institution and other services, in relation to the implementation of financial products supported by the EU guarantee if requested by that national promotional bank or institution; (d) shall, in relation to the InvestEU Advisory Hub: (i) be allocated an amount of up to EUR 300 000 000 for the advisory initiatives referred to in Article 25 and operational tasks referred to in point (ii) of this point out of the financial envelope referred to in Article 4(3); (ii) advise the Commission and perform operational tasks set out in the agreement referred to in point (c) of paragraph 3, by: — providing support to the Commission in the design, the establishment and operation of the InvestEU Advisory Hub; — providing an assessment of requests for advisory support that the Commission does not consider to fall under existing advisory initiatives, with a view to supporting the allocation decision of the Commission in relation to advisory requests received under the central point of entry defined in point (a) of Article 25(2); — providing support to national promotional banks and institutions by providing capacity building referred to in point (h) of Article 25(2) in relation to the development of their advisory capabilities to enable them to participate in advisory initiatives, at the request of such banks or institutions; — at the request of the Commission and of a potential advisory partner, and subject to the agreement of the EIB Group, concluding on behalf of the Commission an agreement with the advisory partner for the delivery of advisory initiatives. The EIB Group shall ensure that its tasks as referred to in point (d)(ii) of the first subparagraph are conducted entirely independently from its role as an advisory partner. As appropriate, the Commission shall engage with the implementing partner on the basis of the findings of the opinion of the EIB Group referred to in point (b)(iv) of the first subparagraph. The Commission shall inform the EIB Group of the outcome of its decision-making. 2. The banking-related information transmitted to the EIB Group by the Commission in accordance with points (b)(ii), (b)(iv), (b)(v) and (b)(vi) of the first subparagraph of paragraph 1 shall be limited to information strictly necessary for the EIB Group to fulfil its obligations under those points. The Commission, in close dialogue with the EIB Group and potential implementing partners, shall define the nature and scope of that banking-related information, taking into account the requirements for the sound financial management of the EU guarantee, the legitimate interests of the implementing partner regarding commercially sensitive information and the needs of the EIB Group in meeting its obligations under those points. 3. The terms of the partnership shall be laid down in agreements, including: (a) on the granting and implementation of the portion of the EU guarantee specified in Article 13(4): (i) a guarantee agreement between the Commission and the EIB Group; or (ii) separate guarantee agreements between the Commission and the EIB and its subsidiaries or other entities established in accordance with Article 28(1) of the EIB Statute, as applicable; (b) an agreement between the Commission and the EIB Group in relation to points (b) and (c) of the first subparagraph of paragraph 1; (c) an agreement between the Commission and the EIB Group in relation to the InvestEU Advisory Hub; (d) service agreements between the EIB Group and national promotional banks and institutions concerning capacity building and other services provided under point (c) of the first subparagraph of paragraph 1. 4. Without prejudice to Articles 18(3) and 25(4) of this Regulation, the costs incurred by the EIB Group in the performance of tasks referred to in points (b) and (c) of the first subparagraph of paragraph 1 of this Article shall be in accordance with the terms of the agreement referred to in point (b) of paragraph 3 of this Article and may be covered from the repayments or revenues attributable to the EU guarantee, or from the provisioning, in accordance with Article 211(4) and (5) of the Financial Regulation, or may be charged to the financial envelope referred to in Article 4(3) of this Regulation, upon justification of those costs by the EIB Group, subject to an overall cap of EUR 7 000 000. 5. The costs incurred by the EIB Group for the performance of the operational tasks referred to in point (d)(ii) of the first subparagraph of paragraph 1 shall be fully covered by and paid from the amount referred to in point (d)(i) of the first subparagraph of paragraph 1, upon justification of those costs by the EIB Group, subject to an overall cap of EUR 10 000 000. Article 12 Conflicts of interest 1. Within the framework of the partnership as referred to in Article 11, the EIB Group shall take all necessary measures and precautions to avoid conflicts of interest with other implementing partners, including by putting in place a dedicated and independent team for the tasks referred to in points (b)(iii) to (vi) of the first subparagraph of Article 11(1). That team shall be subject to strict confidentiality rules, which shall continue to apply to members of the team after they have left the team. 2. The EIB Group and other implementing partners shall inform the Commission without delay of any situation that constitutes a conflict of interest or is likely to lead to a conflict of interest. In the event of doubt, the Commission shall determine whether a conflict of interest exists and shall inform the EIB Group of its conclusion. In the event of a conflict of interest, the EIB Group shall take appropriate measures. The EIB Group shall inform the Steering Board of those measures and their results. 3. The EIB Group shall take the necessary precautions to avoid situations in which a conflict of interest could arise in the implementation of the InvestEU Advisory Hub, in particular in relation to its operational tasks in its role of supporting the Commission as referred to in point (d)(ii) of the first subparagraph of Article 11(1). In the event of a conflict of interest, the EIB Group shall take appropriate measures. CHAPTER IV EU guarantee Article 13 EU guarantee 1. The EU guarantee shall be granted as an irrevocable, unconditional and on demand guarantee to the implementing partners in accordance with Article 219(1) of the Financial Regulation and implemented in indirect management in accordance with Title X of that Regulation. 2. The remuneration for the EU guarantee shall be linked to the characteristics and risk profile of the financial products, taking into account the nature of the underlying financing and investment operations and the fulfilment of the policy objectives targeted by the financial products. Where duly justified by the nature of the policy objectives targeted by the financial product and the need for the financial products to be affordable to the targeted final recipients, the cost of the financing provided to the final recipient may be reduced or the terms of that financing may be improved, by reducing the remuneration for the EU guarantee, or, where necessary, by covering the outstanding administrative costs borne by the implementing partner through the Union budget, in particular: (a) where stressed financial market conditions would prevent the realisation of a financing or investment operation under market-based pricing; or (b) where necessary to catalyse financing and investment operations in sectors or areas experiencing a significant market failure or suboptimal investment situation or to facilitate the establishment of investment platforms. The reduction of the remuneration for the EU guarantee or the coverage of the outstanding administrative costs borne by the implementing partner, referred to in the second subparagraph, may only be done to the extent that it does not significantly impact the provisioning for the EU guarantee. The reduction of the remuneration for the EU guarantee shall fully benefit final recipients. 3. The condition set out in Article 219(4) of the Financial Regulation shall apply to each implementing partner on a portfolio basis. 4. 75 % of the EU guarantee under the EU compartment as referred to in the first subparagraph of Article 4(1), amounting to EUR 19 614 232 554, shall be granted to the EIB Group. The EIB Group shall provide an aggregate financial contribution amounting to EUR 4 903 558 139. That contribution shall be provided in a manner and form that facilitates the implementation of the InvestEU Fund and the achievement of the objectives set out in Article 15(2). 5. The remaining 25 % of the EU guarantee under the EU compartment shall be granted to other implementing partners, which shall also provide a financial contribution to be determined in the guarantee agreements. 6. Best efforts shall be made to ensure that, at the end of the investment period, a wide range of sectors and regions are covered and excessive sectoral or geographical concentration is avoided. Those efforts shall include incentives for smaller or less sophisticated national promotional banks and institutions that have a comparative advantage due to their local presence, knowledge and investment competencies. The Commission shall develop a coherent approach to support those efforts. 7. Support under the EU guarantee referred to in the first subparagraph of Article 4(2) of this Regulation shall be granted under the conditions set out in Article 3(6) of Regulation (EU) 2020/2094. In other cases, support under the EU guarantee may be granted for financing and investment operations covered by this Regulation for an investment period ending on 31 December 2027. Contracts between the implementing partner and the final recipient or the financial intermediary or other entity referred to in point (a) of Article 16(1) under the EU guarantee referred to in the first subparagraph of Article 4(2) shall be signed at the latest one year after the approval of the relevant financing or investment operation by the implementing partner. In other cases, contracts between the implementing partner and the final recipient or the financial intermediary or other entity referred to in point (a) of Article 16(1) shall be signed by 31 December 2028. Article 14 Eligible financing and investment operations 1. The InvestEU Fund shall only support financing and investment operations that: (a) comply with the conditions set out in points (a) to (e) of Article 209(2) of the Financial Regulation, in particular regarding market failures, suboptimal investment situations and additionality as set out in points (a) and (b) of Article 209(2) of the Financial Regulation and in Annex V to this Regulation and, where appropriate, maximising private investment in accordance with point (d) of Article 209(2) of the Financial Regulation; (b) contribute to the Union policy objectives and fall within the scope of the areas eligible for financing and investment operations under the appropriate policy window in accordance with Annex II to this Regulation; (c) do not provide financial support to the excluded activities set out in Section B of Annex V to this Regulation; and (d) are consistent with the investment guidelines. 2. In addition to projects situated in the Union, or in an overseas country or territory linked to a Member State as set out in Annex II to the TFEU, the InvestEU Fund may support the following projects and operations through financing and investment operations: (a) projects involving entities located or established in one or more Member States that extend to one or more third countries, including acceding countries, candidate countries and potential candidates, countries falling within the scope of the European Neighbourhood Policy, the EEA or the EFTA, to an overseas country or territory as set out in Annex II to the TFEU, or to an associated third country, regardless of whether there is a partner in those third countries or overseas countries or territories; (b) financing and investment operations in third countries as referred to in Article 5 which have contributed to a specific financial product. 3. The InvestEU Fund may support financing and investment operations that provide finance to final recipients which are legal entities established in any of the following countries or territories: (a) a Member State or an overseas country or territory linked to a Member State as set out in Annex II to the TFEU; (b) a third country associated to the InvestEU Programme in accordance with Article 5; (c) a third country referred to in point (a) of paragraph 2, where applicable; (d) other third countries, where necessary for the financing of a project in a country or territory referred to in points (a), (b) or (c). Article 15 Selection of implementing partners other than the EIB Group 1. The Commission shall select implementing partners other than the EIB Group in accordance with Article 154 of the Financial Regulation. Implementing partners may form a group. An implementing partner may be a member of one or more groups. For the EU compartment, the eligible counterparties shall have expressed their interest in relation to the portion of the EU guarantee referred to in Article 13(5). For the Member State compartment, the Member State concerned may propose one or more counterparties as implementing partners from among those counterparties that have expressed their interest. The Member State concerned may also propose the EIB Group as an implementing partner and, at its own expense, may contract the EIB Group to provide the services listed in Article 11. Where the Member State concerned does not propose an implementing partner, the Commission shall proceed in accordance with the third subparagraph of this paragraph and shall select as implementing partners eligible counterparties that are able to cover the financing and investment operations in the geographical areas concerned. 2. When selecting implementing partners, the Commission shall ensure that the portfolio of financial products under the InvestEU Fund meets the following objectives: (a) maximising the coverage of the objectives laid down in Article 3; (b) maximising the impact of the EU guarantee through the own resources committed by the implementing partner; (c) maximising, where appropriate, private investment; (d) promoting innovative financial and risk solutions to address market failures and suboptimal investment situations; (e) achieving geographical diversification via gradual allocation of the EU guarantee, and to allow for the financing of smaller projects; (f) providing sufficient risk diversification. 3. When selecting the implementing partners, the Commission shall also take into account: (a) the possible cost and remuneration to the Union budget; (b) the capacity of the implementing partner to implement thoroughly the requirements of Article 155(2) and (3) of the Financial Regulation related to tax avoidance, tax fraud, tax evasion, money laundering, terrorism financing and non-cooperative jurisdictions. 4. National promotional banks and institutions may be selected as implementing partners, provided that they fulfil the requirements laid down in this Article. Article 16 Eligible types of financing 1. The EU guarantee may be used towards risk coverage for the following types of financing provided by the implementing partners: (a) loans, guarantees, counter-guarantees, capital market instruments, any other form of funding or credit enhancement, including subordinated debt, or equity or quasi-equity investments, provided directly or indirectly through financial intermediaries, funds, investment platforms or other vehicles to be channelled to final recipients; (b) funding or guarantees by an implementing partner to another financial institution enabling the latter to undertake financing referred to in point (a). In order to be covered by the EU guarantee, the financing referred to in points (a) and (b) of the first subparagraph of this paragraph shall be granted, acquired or issued for the benefit of financing and investment operations referred to in Article 14(1), where the financing by the implementing partner was granted in accordance with a financing agreement or transaction signed or entered into by the implementing partner after the signature of the guarantee agreement and that has not expired or been cancelled. 2. Financing and investment operations through funds or other intermediate structures shall be supported by the EU guarantee in accordance with provisions to be laid down in the investment guidelines, even if such structures invest a minority of their invested amounts outside the Union and in third countries referred to Article 14(2) or invest a minority of their invested amounts into assets other than those eligible under this Regulation. Article 17 Guarantee agreements 1. The Commission shall conclude a guarantee agreement with each implementing partner on the granting of the EU guarantee up to an amount to be determined by the Commission. In the event that implementing partners form a group, a single guarantee agreement shall be concluded between the Commission and each implementing partner within the group or with one implementing partner on behalf of the group. 2. The guarantee agreement shall contain: (a) the amount and the terms of the financial contribution which is to be provided by the implementing partner; (b) the terms of the funding or the guarantees which are to be provided by the implementing partner to another legal entity participating in the implementation, whenever that is the case; (c) detailed rules on the provision of the EU guarantee in accordance with Article 19, including on the coverage of portfolios of specific types of instruments and the respective events that trigger possible calls on the EU guarantee; (d) the remuneration for risk-taking that is to be allocated in proportion to the respective share of the risk-taking of the Union and of the implementing partner or as reduced in duly justified cases pursuant to Article 13(2); (e) the payment conditions; (f) the commitment of the implementing partner to accept the decisions by the Commission and the Investment Committee as regards the use of the EU guarantee for the benefit of a proposed financing or investment operation, without prejudice to the decision-making of the implementing partner in respect of the proposed financing or investment operation without the EU guarantee; (g) provisions and procedures relating to the recovery of claims that is to be entrusted to the implementing partner; (h) financial and operational reporting and monitoring of the financing and investment operations under the EU guarantee; (i) key performance indicators, in particular as regards the use of the EU guarantee, the fulfilment of the objectives and criteria laid down in Articles 3, 8 and 14, and the mobilisation of private capital; (j) where applicable, provisions and procedures relating to blending operations; (k) other relevant provisions in compliance with the requirements of Article 155(2) and Title X of the Financial Regulation; (l) the existence of adequate mechanisms for addressing the potential concerns of private investors. 3. A guarantee agreement shall also provide that remuneration attributable to the Union from financing and investment operations covered by this Regulation is to be provided after the deduction of payments due upon calls on the EU guarantee. 4. In addition, a guarantee agreement shall provide that any amount due to the implementing partner that relates to the EU guarantee shall be deducted from the overall amount of remuneration, revenues and repayments due by the implementing partner to the Union from financing and investment operations covered by this Regulation. Where that amount is not sufficient to cover the amount due to the implementing partner in accordance with Article 18(3), the outstanding amount shall be drawn from the provisioning for the EU guarantee. 5. Where the guarantee agreement is concluded under the Member State compartment, it may provide for the participation of representatives from the Member State or the regions concerned in the monitoring of the implementation of that guarantee agreement. Article 18 Requirements for the use of the EU guarantee 1. The granting of the EU guarantee shall be subject to the entry into force of the guarantee agreement with the relevant implementing partner. 2. Financing and investment operations shall be covered by the EU guarantee only where they fulfil the criteria laid down in this Regulation and in the relevant investment guidelines, and where the Investment Committee has concluded that those operations fulfil the requirements for benefiting from the EU guarantee. The implementing partners shall remain responsible for ensuring that the financing and investment operations comply with this Regulation and the relevant investment guidelines. 3. No administrative costs or fees related to the implementation of financing and investment operations under the EU guarantee shall be due to the implementing partner by the Commission unless the nature of the policy objectives targeted by the financial product to be implemented and the affordability for the targeted final recipients or the type of financing provided allow the implementing partner to duly justify to the Commission the need for an exception. The coverage of such costs by the Union budget shall be limited to the amount strictly required to implement the relevant financing and investment operations, and shall be provided only to the extent to which the costs are not covered by revenues received by the implementing partners from the financing and investment operations concerned. The fee arrangements shall be laid down in the guarantee agreement and shall comply with Article 17(4) of this Regulation and with point (g) of Article 209(2) of the Financial Regulation. 4. In addition, the implementing partner may use the EU guarantee to meet the relevant share of any recovery costs in accordance with Article 17(4), unless those costs have been deducted from recovery proceeds. Article 19 Coverage and terms of the EU guarantee 1. Remuneration for risk-taking shall be allocated between the Union and an implementing partner in proportion to their respective share of the risk-taking with respect to a portfolio of financing and investment operations or, where relevant, with respect to individual financing and investment operations. The remuneration for the EU guarantee may be reduced in duly justified cases referred to in Article 13(2). The implementing partner shall have appropriate exposure at its own risk to financing and investment operations supported by the EU guarantee, unless exceptionally the policy objectives targeted by the financial product to be implemented are of such nature that the implementing partner could not reasonably contribute its own risk-bearing capacity to it. 2. The EU guarantee shall cover: (a) for debt products referred to in point (a) of Article 16(1): (i) the principal and all interest and amounts due to the implementing partner but not received by it in accordance with the terms of the financing operations prior to the event of default; (ii) restructuring losses; (iii) losses arising from fluctuations of currencies other than the euro in markets where possibilities for long-term hedging are limited; (b) for equity or quasi-equity investments referred to in point (a) of Article 16(1): the amounts invested and the associated funding costs and losses arising from fluctuations of currencies other than the euro; (c) for funding or guarantees by an implementing partner to another financial institution in accordance with point (b) of Article 16(1): the amounts used and their associated funding costs. For the purposes of point (a)(i) of the first subparagraph, for subordinated debt a deferral, reduction or required exit shall be considered to be an event of default. 3. Where the Union makes a payment to the implementing partner as the result of a call on the EU guarantee, the Union shall be subrogated into the relevant rights of the implementing partner relating to any of its financing or investment operations covered by the EU guarantee, to the extent that those rights continue to exist. The implementing partner shall pursue the recovery of claims for the subrogated amounts on behalf of the Union and shall reimburse the Union from the amounts recovered. CHAPTER V Governance Article 20 Advisory Board 1. The Commission and the Steering Board established pursuant to Article 21 shall be advised by an advisory board (the ‘Advisory Board’). 2. The Advisory Board shall strive to ensure gender balance and shall comprise: (a) one representative of each implementing partner; (b) one representative of each Member State; (c) one expert appointed by the European Economic and Social Committee; (d) one expert appointed by the Committee of the Regions. 3. The Advisory Board shall be chaired by a representative of the Commission. The representative of the EIB Group shall be the vice-chair. The Advisory Board shall meet regularly, at least twice a year, at the request of the Chairperson. 4. The Advisory Board shall: (a) provide advice to the Commission and the Steering Board on the design of financial products to be deployed under this Regulation; (b) provide advice to the Commission and the Steering Board about market developments, market conditions, market failures and suboptimal investment situations; (c) exchange views on market developments and share best practices. 5. The Commission shall nominate the first Advisory Board members representing the implementing partners other than the EIB Group after consultation of potential implementing partners. Their term is limited to one year. 6. Meetings of representatives of the Member States in a separate format shall also be organised at least twice a year and chaired by the Commission. 7. The Advisory Board and the meetings of the representatives of the Member States referred to in paragraph 6 may issue recommendations to the Steering Board for its consideration regarding the implementation and operation of the InvestEU Programme. 8. Detailed minutes of the meetings of the Advisory Board shall be made public as soon as possible after they have been approved by the Advisory Board. The Commission shall establish the operating rules and procedures for the Advisory Board and shall manage the secretariat of the Advisory Board. All relevant documentation and information shall be made available to the Advisory Board to enable it to exercise its tasks. 9. The national promotional banks and institutions represented on the Advisory Board shall select from among themselves the representatives of the implementing partners other than the EIB Group in the Steering Board established pursuant to Article 21. The national promotional banks and institutions shall aim to achieve a balanced representation in the Steering Board in terms of size and geographical location. The representatives selected shall represent the agreed common position of all implementing partners other than the EIB Group. Article 21 Steering Board 1. A steering board for the InvestEU Programme (the ‘Steering Board’) shall be established. It shall be composed of four representatives of the Commission, three representatives of the EIB Group and two representatives of the implementing partners other than the EIB Group and one expert appointed as a non-voting member by the European Parliament. The expert appointed as a non-voting member by the European Parliament shall not seek or take instructions from Union institutions, bodies, offices or agencies, from any Member State government or from any other public or private body and shall act with full independence. That expert shall perform his or her duties impartially and in the interest of the InvestEU Programme. Members of the Steering Board shall be appointed for a term of four years, renewable once, with the exception of the representatives of the implementing partners other than the EIB Group, who shall be appointed for a term of two years. 2. The Steering Board shall select a Chairperson from among the Commission representatives for a term of four years, renewable once. The Chairperson shall report biannually to the representatives of the Member States on the Advisory Board on the implementation and operation of the InvestEU Programme. Detailed minutes of Steering Board meetings shall be published as soon as they have been approved by the Steering Board. 3. The Steering Board shall: (a) provide strategic and operational guidance for the implementing partners, including guidance on the design of financial products and on other operating policies and procedures necessary for the operation of the InvestEU Fund; (b) adopt the risk methodological framework developed by the Commission in cooperation with the EIB Group and the other implementing partners; (c) oversee the implementation of the InvestEU Programme; (d) be consulted, reflecting the views of all its member, on the shortlist of candidates for the Investment Committee before their selection in accordance with Article 24(2); (e) adopt the rules of procedure of the secretariat to the Investment Committee referred to in Article 24(4). (f) adopt the rules applicable to the operations with investment platforms. 4. The Steering Board shall use a consensual approach in its discussions, therefore taking the utmost possible account of the positions of all members. If the members cannot converge in their positions, decisions of the Steering Board are taken by qualified majority of its voting members, consisting of at least seven votes. Article 22 Scoreboard 1. A scoreboard of indicators (the ‘Scoreboard’) shall be established to ensure that the Investment Committee is able to carry out an independent, transparent and harmonised assessment of requests for the use of the EU guarantee for financing and investment operations proposed by implementing partners. 2. Implementing partners shall fill out the Scoreboard for their proposals for financing and investment operations. 3. The Scoreboard shall cover the following elements: (a) a description of the proposed financing or investment operation; (b) how the proposed financing or investment operation contributes to EU policy objectives; (c) a description of additionality; (d) a description of the market failure or suboptimal investment situation; (e) the financial and technical contribution by the implementing partner; (f) the impact of the investment; (g) the financial profile of the financing or investment operation; (h) complementary indicators. 4. The Commission is empowered to adopt delegated acts in accordance with Article 34 in order to supplement this Regulation by establishing additional elements of the Scoreboard, including detailed rules for the Scoreboard to be used by the implementing partners. Article 23 Policy check 1. The Commission shall conduct a check to confirm that the financing and investment operations proposed by the implementing partners other than the EIB comply with Union law and policies. 2. EIB financing and investment operations that fall within the scope of this Regulation shall not be covered by the EU guarantee where the Commission delivers an unfavourable opinion within the framework of the procedure provided for in Article 19 of the EIB Statute. Article 24 Investment Committee 1. A fully independent investment committee shall be established for the InvestEU Fund (the ‘Investment Committee’). The Investment Committee shall: (a) examine the proposals for financing and investment operations submitted by implementing partners for coverage under the EU guarantee that have passed the policy check referred to in Article 23(1) of this Regulation or that have received a favourable opinion within the framework of the procedure provided for in Article 19 of the EIB Statute; (b) verify the compliance of the proposals referred to in point (a) with this Regulation and the relevant investment guidelines; and (c) check whether the financing and investment operations that would benefit from the support under the EU guarantee comply with all relevant requirements. When performing the tasks referred to in the first subparagraph of this paragraph, the Investment Committee shall give particular attention to the additionality requirements set out in point (b) of Article 209(2) of the Financial Regulation and in Annex V to this Regulation and to the requirement to crowd in private investment set out in point (d) of Article 209(2) of the Financial Regulation. 2. The Investment Committee shall meet in four different configurations, corresponding to the four policy windows referred to in Article 8(1). Each configuration of the Investment Committee shall be composed of six remunerated external experts. The experts shall be selected and shall be appointed by the Commission, at the recommendation of the Steering Board. The experts shall be appointed for a term of up to four years, renewable once. They shall be remunerated by the Union. The Commission, at the recommendation of the Steering Board, may decide to renew the term of office of an incumbent member of the Investment Committee without following the procedure laid down in this paragraph. The experts shall have a high level of relevant market experience in project structuring and financing or financing of SMEs or corporates. The composition of the Investment Committee shall ensure that it has a wide knowledge of the sectors covered by the policy windows referred to in Article 8(1) and a wide knowledge of the geographic markets in the Union, and shall ensure that the Investment Committee as a whole is gender-balanced. Four members of the Investment Committee shall be permanent members of each of the four configurations of the Investment Committee. At least one of the permanent members shall have expertise in sustainable investment. In addition, each of the four configurations shall have two experts with experience in investment in sectors covered by the corresponding policy window. The Steering Board shall assign the Investment Committee members to the appropriate configuration or configurations. The Investment Committee shall elect a chairperson from among its permanent members. 3. When participating in the activities of the Investment Committee, its members shall perform their duties impartially and in the sole interest of the InvestEU Fund. They shall not seek or take instructions from the implementing partners, the institutions of the Union, the Member States, or any other public or private body. The curricula vitae and declarations of interest of each member of the Investment Committee shall be made public and kept up to date. Each member of the Investment Committee shall without delay communicate to the Commission and the Steering Board all information needed to confirm the absence of any conflict of interest on an ongoing basis. The Steering Board may recommend to the Commission that it remove a member from his or her functions if that member does not comply with the requirements laid down in this paragraph or for other duly justified reasons. 4. When acting in accordance with this Article, the Investment Committee shall be assisted by a secretariat. The secretariat shall be independent and answerable to the chairperson of the Investment Committee. The secretariat shall be administratively located in the Commission. The rules of procedure of the secretariat shall ensure the confidentiality of exchanges of information and documents between implementing partners and the respective governing bodies. The EIB Group may submit its proposals for financing and investment operations directly to the Investment Committee and shall notify them to the secretariat. The documentation to be provided by the implementing partners shall comprise a standardised request form, the Scoreboard referred to in Article 22 and any other document the Investment Committee considers relevant, in particular a description of the character of the market failure or suboptimal investment situation and how it will be alleviated by the financing or investment operation, as well as a reliable assessment of the operation that demonstrates the additionality of the financing or investment operation. The secretariat shall check the completeness of the documentation provided by implementing partners other than the EIB Group. The Investment Committee may seek clarifications from the implementing partner concerned in relation to a proposal for an investment or financing operation, including by requesting the direct presence of a representative of the implementing partner concerned during the discussion of the aforementioned operation. Any project assessment conducted by an implementing partner shall not be binding on the Investment Committee for the purposes of granting a financing or investment operation coverage by the EU guarantee. The Investment Committee shall use the Scoreboard referred to in Article 22 in its assessment and verification of the proposed financial and investment operations. 5. Conclusions of the Investment Committee shall be adopted by simple majority of all members, provided that such simple majority includes at least one of the non-permanent members of the configuration relating to the policy window under which the proposal is made. In the event of a draw, the chair of the Investment Committee shall have the casting vote. Conclusions of the Investment Committee approving the coverage of the EU guarantee for a financing or investment operation shall be publicly accessible and shall include the rationale for the approval and information on the operation, in particular its description, the identity of the promoters or financial intermediaries, and the objectives of the operation. The conclusions shall also refer to the global assessment stemming from the Scoreboard. The relevant Scoreboard shall be made publicly accessible after the signature of the financing or investment operation or sub-project, if applicable. Information to be made publicly accessible under the second and third subparagraphs shall not contain commercially sensitive information or personal data that are not to be disclosed under the Union data protection rules. Commercially sensitive parts of the conclusions of the Investment Committee shall be forwarded by the Commission to the European Parliament and to the Council upon request subject to strict confidentiality requirements. Twice a year, the Investment Committee shall submit to the European Parliament and to the Council a list of all conclusions of the Investment Committee in the preceding six months, as well as the published Scoreboards relating thereto. That submission shall include any decisions rejecting the use of the EU guarantee. Those decisions shall be subject to strict confidentiality requirements. Conclusions of the Investment Committee shall be made available in a timely manner to the implementing partner concerned by the secretariat of the Investment Committee. The secretariat of the Investment Committee shall record all information related to proposals for financing and investment operations provided to the Investment Committee and the conclusions of the Investment Committee on those proposals in a central repository. 6. Where the Investment Committee is requested to approve the use of the EU guarantee for a financing or investment operation that is a facility, programme or structure which has underlying sub-projects, that approval shall comprise those underlying sub-projects unless the Investment Committee decides to retain the right to approve them separately. The Investment Committee shall not have the right to separately approve sub-projects of a size below EUR 3 000 000. 7. Where it deems it necessary, the Investment Committee may bring to the Commission any operational issue relating to the application or interpretation of the investment guidelines. CHAPTER VI InvestEU Advisory Hub Article 25 InvestEU Advisory Hub 1. The Commission shall establish the InvestEU Advisory Hub. The InvestEU Advisory Hub shall provide advisory support for the identification, preparation, development, structuring, procuring and implementation of investment projects, and for enhancing the capacity of project promoters and financial intermediaries to implement financing and investment operations. Such support may cover any stage of the life cycle of a project or financing of a supported entity. The Commission shall conclude advisory agreements with the EIB Group and other potential advisory partners and task them with the provision of advisory support as referred to in the first subparagraph of this paragraph and of the services referred to in paragraph 2. The Commission may also implement advisory initiatives, including through contracting external service providers. The Commission shall establish a central entry point to the InvestEU Advisory Hub and shall allocate requests for advisory support to be dealt under the appropriate advisory initiative. The Commission, the EIB Group and the other advisory partners shall cooperate closely with a view to ensuring efficiency, synergies and effective geographic coverage of support across the Union, while taking due account of existing structures and work. Advisory initiatives shall be available as a component under each policy window referred to in Article 8(1), covering sectors under that window. In addition, advisory initiatives shall be available under a cross-sectoral component. 2. The InvestEU Advisory Hub shall in particular: (a) provide a central point of entry, managed and hosted by the Commission, for project development assistance under the InvestEU Advisory Hub for public authorities and for project promoters; (b) disseminate to public authorities and project promoters all available additional information regarding the investment guidelines, including information on their application or on the interpretation provided by the Commission; (c) where appropriate, assist project promoters in developing their projects so that they fulfil the objectives set out in Articles 3 and 8 and the eligibility criteria set out in Article 14, and facilitate the development of among others important projects of common European interest and aggregators for small-sized projects, including through investment platforms as referred to in point (f) of this paragraph, provided that such assistance does not prejudge the conclusions of the Investment Committee with respect to the coverage of the EU guarantee with respect to such projects; (d) support actions and leverage local knowledge to facilitate the use of InvestEU Fund support across the Union and contribute actively where possible to the objective of the sectorial and geographical diversification of the InvestEU Fund by supporting implementing partners in originating and developing potential financing and investment operations; (e) facilitate the establishment of collaborative platforms for peer-to-peer exchanges and the sharing of data, knowhow and best practices to support project pipeline and sector development; (f) provide proactive advisory support with respect to the establishment of investment platforms, including cross-border and macro-regional investment platforms and investment platforms that bundle small and medium-sized projects in one or more Member States by theme or by region; (g) support the use of blending with grants or financial instruments funded by the Union budget or by other sources in order to strengthen synergies and complementarities between Union instruments and to maximise the leverage and impact of the InvestEU Programme; (h) support capacity building actions to develop organisational capacities, skills and processes and to accelerate the investment readiness of organisations in order for public authorities and project promoters to build investment project pipelines, develop financing mechanisms and investment platforms and to manage projects and for financial intermediaries to implement financing and investment operations for the benefit of entities that face difficulties in obtaining access to finance, including through support for developing risk assessment capacity or sector specific knowledge; (i) providing advisory support for start-ups, especially when they seek to protect their research and innovation investments by obtaining intellectual property titles, such as patents. 3. The InvestEU Advisory Hub shall be available to public and private project promoters, including SMEs and start-ups, to public authorities, to national promotional banks and institutions, and to financial and non-financial intermediaries. 4. The Commission shall conclude an advisory agreement with each advisory partner on the implementation of one or more advisory initiatives. The InvestEU Advisory Hub may charge fees for the services referred to in paragraph 2 to cover part of the costs for providing those services, except for services provided to public project promoters or non-profit institutions, which shall be free of charge where justified. Fees charged to SMEs for those services referred to in paragraph 2 shall be capped at one third of the cost of providing those services. 5. In order to carry out the activities referred to in paragraph 1 and to facilitate the provision of advisory support, the InvestEU Advisory Hub shall build upon the expertise of the Commission, the EIB Group and the other advisory partners. 6. Each advisory initiative shall incorporate a cost-sharing mechanism between the Commission and the advisory partner, except where the Commission agrees to cover all costs of the advisory initiative in a duly justified case where the specificities of the advisory initiative so require and the coherent and equitable treatment of advisory partners concerned is ensured. 7. The InvestEU Advisory Hub shall have local presence where necessary. Local presence shall be established in particular in Member States or regions that face difficulties in developing projects under the InvestEU Fund. The InvestEU Advisory Hub shall assist in the transfer of knowledge to the regional and local level with a view to building up regional and local capacity and expertise to be able to provide advisory support referred to in paragraph 1, including support to implement and accommodate small-sized projects. 8. In order to provide the advisory support referred in paragraph 1 and to facilitate the provision of that advisory support at local level, the InvestEU Advisory Hub shall cooperate where possible with and take advantage of the expertise of national promotional banks and institutions. Where appropriate, cooperation agreements with national promotional banks and institutions shall be concluded under the InvestEU Advisory Hub, with at least one national promotional bank or institution per Member State. 9. The implementing partners shall, as appropriate, propose to project promoters applying for financing, including in particular small-sized projects, that they request the InvestEU Advisory Hub support for their projects, where appropriate, in order to enhance the preparation of their projects and to allow for the assessment of the possibility of bundling projects. Where relevant, the implementing partners and advisory partners shall also inform the project promoters of the possibility of listing their projects on the InvestEU Portal referred to in Article 26. CHAPTER VII InvestEU Portal Article 26 InvestEU Portal 1. The Commission shall establish the InvestEU Portal. The InvestEU Portal shall be an easily accessible and user-friendly project database that provides relevant information for each project. 2. The InvestEU Portal shall provide a channel for project promoters to make projects for which they are seeking finance visible to investors. The inclusion of projects in the InvestEU Portal shall be without prejudice to decisions on the final projects selected for support under this Regulation or under any other Union instrument, or to decisions for public funding. Only projects that are compatible with Union law and policies shall be listed on the InvestEU Portal. 3. The Commission shall transmit projects that are compatible with Union law and policies to the relevant implementing partners. Where appropriate and where an advisory initiative exists, the Commission shall also transmit such projects to the InvestEU Advisory Hub. 4. Implementing partners shall examine projects falling within their geographic and activity scope. CHAPTER VIII Accountability, monitoring and reporting, evaluation and control Article 27 Accountability 1. At the request of the European Parliament or of the Council, the Chairperson of the Steering Board shall report on the performance of the InvestEU Fund to the requesting institution, including by participating in a hearing before the European Parliament. 2. The Chairperson of the Steering Board shall reply orally or in writing to questions addressed to the InvestEU Fund by the European Parliament or by the Council within five weeks of their receipt. Article 28 Monitoring and reporting 1. Indicators to report on the progress of the InvestEU Programme towards the achievement of the general and specific objectives laid down in Article 3 are set out in Annex III. 2. The performance reporting system shall ensure that data for monitoring the implementation and the results of the InvestEU Programme are collected efficiently, effectively and in a timely manner, and that those data allow for adequate risk and guarantee portfolio monitoring. To that end, proportionate reporting requirements shall be imposed on the implementing partners, the advisory partners and other recipients of Union funds, as appropriate. 3. The Commission shall report on the implementation of the InvestEU Programme in accordance with Articles 241 and 250 of the Financial Regulation. In accordance with Article 41(5) of the Financial Regulation, the annual report shall provide information on the level of implementation of the Programme with respect to its objectives and performance indicators. For that purpose, each implementing partner shall provide on an annual basis the information necessary to allow the Commission to comply with its reporting obligations, including information on the operation of the EU guarantee. 4. Every six months, each implementing partner shall submit a report to the Commission on the financing and investment operations covered by this Regulation, broken down by EU compartment and Member State compartment, as appropriate. Each implementing partner shall also submit information on the Member State compartment to the Member State whose compartment it implements. The report shall include an assessment of compliance with the requirements on the use of the EU guarantee and with the key performance indicators laid down in Annex III to this Regulation. The report shall also include operational, statistical, financial and accounting data on each financing or investment operation and an estimation of expected cash flows, at the level of compartment, policy window and the InvestEU Fund. Once a year, the report from the EIB Group and, where appropriate, from other implementing partners, shall also include information on barriers to investment encountered when carrying out financing and investment operations covered by this Regulation. The reports shall contain the information the implementing partners have to provide under point (a) of Article 155(1) of the Financial Regulation. 5. To ensure the effective assessment of the progress of the InvestEU Programme towards the achievement of its objectives, the Commission is empowered to adopt delegated acts, in accordance with Article 34, to amend Annex III with regard to the indicators where considered necessary as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. Article 29 Evaluation 1. Evaluations of the InvestEU Programme shall be carried out so that they feed into the decision-making process in a timely manner. 2. By 30 September 2024, the Commission shall submit to the European Parliament and to the Council an independent interim evaluation report on the InvestEU Programme, in particular on the use of the EU guarantee, on the fulfilment of the EIB Group’s obligations under points (b) and (c) of the first subparagraph of Article 11(1), on the allocation of the EU guarantee provided for in Article 13(4) and (5), on the implementation of the InvestEU Advisory Hub, on the budgetary allocation provided for in point (d)(i) of the first subparagraph of Article 11(1), and on Article 8(8). The evaluation shall in particular demonstrate how the inclusion of the implementing partners and advisory partners in the implementation of the InvestEU Programme has contributed to the reaching of InvestEU Programme targets as well as EU policy goals, especially with regard to added value and the geographical and sectoral balance of the supported financing and investment operations. The evaluation shall also assess the application of sustainability proofing pursuant to Article 8(5) and the focus on SMEs reached under the SME policy window referred to in point (c) of Article 8(1). 3. At the end of the implementation of the InvestEU Programme, but no later than 31 December 2031, the Commission shall submit to the European Parliament and to the Council an independent final evaluation report on the InvestEU Programme, in particular on the use of the EU guarantee. 4. The Commission shall communicate the conclusions of the evaluations, accompanied by its observations, to the European Parliament, to the Council, to the European Economic and Social Committee and to the Committee of the Regions. 5. The implementing partners and advisory partners shall contribute to and provide the Commission with the information necessary to perform the evaluations referred to in paragraphs 2 and 3. 6. In accordance with Article 211(1) of the Financial Regulation, every three years the Commission shall include in the annual report referred to in Article 250 of the Financial Regulation a review of the adequacy of the provisioning rate laid down in Article 4(1) of this Regulation with respect to the actual risk profile of the financing and investment operations covered by the EU guarantee. The Commission is empowered to adopt delegated acts in accordance with Article 34 of this Regulation in order to amend this Regulation by adjusting the provisioning rate laid down in Article 4(1) of this Regulation by up to 15 % on the basis of that review. Article 30 Audits Audits of the use of the Union funding carried out by persons or entities, including by persons or entities other than those mandated by Union institutions or bodies, shall form the basis of the overall assurance pursuant to Article 127 of the Financial Regulation. Article 31 Protection of the financial interests of the Union Where a third country participates in the InvestEU Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. CHAPTER IX Transparency and visibility Article 32 Information, communication and publicity 1. Implementing partners and advisory partners shall acknowledge the origin and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. The application of the requirements under the first subparagraph to projects in defence and space sectors and in cybersecurity shall be subject to respect for any confidentiality or secrecy obligations. 2. The implementing partners and advisory partners shall inform the final recipients, including SMEs, of the existence of support under the InvestEU Programme, or oblige other financial intermediaries to inform such final recipients of that support, by making that information clearly visible in the relevant agreement providing support under the InvestEU Programme, particularly in the case of SMEs, in order to increase public awareness and improve visibility. 3. The Commission shall implement information and communication actions relating to the InvestEU Programme, to actions taken pursuant to the InvestEU Programme and to the results obtained. Financial resources allocated to the InvestEU Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 3. CHAPTER X Participation of the European Union in the capital increase of the European Investment Fund Article 33 Participation in a capital increase of the EIF In addition to its shareholding in the EIF at 3 December 2020, the Union shall subscribe for up to 853 shares in the EIF, each of a nominal value of EUR 1 000 000, so that its relative share in the capital remains at a level equivalent to that on 3 December 2020. The subscription of the shares and the payment of up to EUR 375 000 000 for the paid-in part of the shares and for the share premium shall be carried out in accordance with terms and conditions that shall be approved by the General Meeting of the EIF and before 31 December 2021. The resulting subscribed but not paid-in part of the shares acquired under this Article shall not exceed EUR 682 400 000. CHAPTER XI Transitional and final provisions Article 34 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. Where delegated acts concern activities to be carried out by or involving the EIB Group and other implementing partners, the Commission shall consult with the EIB Group and other potential implementing partners before preparing those delegated acts. 2. The power to adopt delegated acts referred to in Articles 8(9), 22(4), 28(5) and 29(6) shall be conferred on the Commission until 31 December 2028. The Commission shall draw up a report in respect of the delegation of power not later than nine months before that date. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 8(9), 22(4), 28(5) and 29(6) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 8(9), 22(4), 28(5) and 29(6) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 35 Transitional provisions 1. By way of derogation from the first and fourth subparagraphs of Article 209(3) of the Financial Regulation, any revenues, repayments and recoveries from financial instruments established by programmes referred to in Annex IV to this Regulation may be used for the provisioning of the EU guarantee under this Regulation, taking into account the relevant provisions concerning the budget laid down in the Public Sector Loan Facility Regulation for 2021-2027. 2. By way of derogation from point (a) of Article 213(4) of the Financial Regulation, any surplus of provisions for the EU guarantee established by Regulation (EU) 2015/1017 may be used for the provisioning of the EU guarantee under this Regulation, taking into account the relevant provisions concerning the budget laid down in the Public Sector Loan Facility Regulation for 2021-2027. 3. The amount of EUR 6 074 000 000 in current prices referred to in point (c) of Article 2(2) of Regulation (EU) 2020/2094 shall be used: (a) for the provisioning of the EU guarantee under this Regulation with an amount of EUR 5 930 000 000 in current prices, in addition to the resources mentioned in the first subparagraph of Article 211(4) of the Financial Regulation; (b) for the implementation of the measures provided in Chapters VI and VII of this Regulation and the measures referred to in the second sentence of Article 1(3) of Regulation (EU) 2020/2094, subject to Article 3(4) and (8) of that Regulation, with an amount of EUR 142 500 000 in current prices. That amount shall constitute an external assigned revenue in accordance with Article 21(5) of the Financial Regulation. 4. By way of derogation from the second subparagraph of Article 16(1) of this Regulation, financing and investment operations signed or entered into by an implementing partner during the period from 1 January 2021 until the signature of their respective guarantee agreements may be covered by the EU guarantee provided that those operations are indicated in the guarantee agreement, pass the policy check referred to in Article 23(1) of this Regulation or receive a favourable opinion within the framework of the procedure provided for in Article 19 of the EIB Statute and are in both cases approved by the Investment Committee in accordance with Article 24 of this Regulation. Article 36 Amendment of Regulation (EU) 2015/1017 The following article is inserted in Regulation (EU) 2015/1017: ‘Article 11a Combination of EFSI portfolio with other portfolios By way of derogation from Article 11(6) of this Regulation and the second subparagraph of Article 10(2) of this Regulation, the EU guarantee may cover losses referred to in Article 11(6) of this Regulation in relation to the entire portfolio of financing and investment operations supported by the financial products referred to in Article 7(1) of Regulation (EU) 2021/523 of the European Parliament and of the Council (*1). Article 37 Entry into force This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 March 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 364, 28.10.2020, p. 139. (2) Position of the European Parliament of 9 March 2021 (not yet published in the Official Journal) and decision of the Council of 17 March 2021. (3) Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13). (4) Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17). (5) OJ L 282, 19.10.2016, p. 4. (6) OJ L 309, 13.12.1993, p. 3. (7) Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1). (8) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82). (9) Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p. 1). (10) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (11) OJ L 433I, 22.12.2020, p. 28. (12) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433I, 22.12.2020, p. 11). (13) Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies (OJ L 209, 2.8.1997, p. 1). (14) Council Regulation (EC) No 1467/97 of 7 July 1997 on speeding up and clarifying the implementation of the excessive deficit procedure (OJ L 209, 2.8.1997, p. 6). (15) Regulation (EU) 2015/1017 of the European Parliament and of the Council of 25 June 2015 on the European Fund for Strategic Investments, the European Investment Advisory Hub and the European Investment Project Portal and amending Regulations (EU) No 1291/2013 and (EU) No 1316/2013 — the European Fund for Strategic Investments (OJ L 169, 1.7.2015, p. 1). (16) OJ C 170, 18.5.2020, p. 22. (17) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433I , 22.12.2020, p. 23). (18) OJ L 123, 12.5.2016, p. 1. (19) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (20) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (21) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (22) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1). (23) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (24) OJ L 1, 3.1.1994, p. 3. (25) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (‘Overseas Association Decision’) (OJ L 344, 19.12.2013, p. 1). (26) OJ L 29, 31.1.2020, p. 7. (27) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). ANNEX I AMOUNTS OF EU GUARANTEE PER SPECIFIC OBJECTIVE The indicative distribution referred to in the fourth subparagraph of Article 4(2) towards financial and investment operations shall be as follows: (a) up to EUR 9 887 682 891 for objectives referred to in point (a) of Article 3(2); (b) up to EUR 6 575 653 460 for objectives referred to in point (b) of Article 3(2); (c) up to EUR 6 906 732 440 for objectives referred to in point (c) of Article 3(2); (d) up to EUR 2 782 241 282 for objectives referred to in point (d) of Article 3(2). ANNEX II AREAS ELIGIBLE FOR FINANCING AND INVESTMENT OPERATIONS The financing and investment operations may include strategic investment to support final recipients whose activities are of strategic importance to the Union, in particular in view of the green and digital transitions, of enhanced resilience and of strengthening strategic value chains. They may include important projects of common European interest. The financing and investment operations may fall under one or more of the following areas: (1) the development of the energy sector in accordance with the Energy Union priorities, including security of energy supply, clean energy transition and the commitments taken under the 2030 Agenda for Sustainable Development and the Paris Agreement, in particular through: (a) the expansion of the generation, supply or use of clean and sustainable renewable and safe and sustainable other zero and low-emission energy sources and solutions; (b) energy efficiency and energy savings (with a focus on reducing demand through demand side management and the refurbishment of buildings); (c) the development, smartening and modernisation of sustainable energy infrastructure, in particular storage technologies, electricity interconnections between Member States and smart grids, both at the transmission and distribution level; (d) the development of innovative zero- and low-emission heat supply systems and the combined production of electricity and heat; (e) the production and supply of sustainable synthetic fuels from renewable/carbon-neutral sources and other safe and sustainable zero- and low-emission sources, biofuels, biomass and alternative fuels, including fuels for all modes of transport, in accordance with the objectives of Directive (EU) 2018/2001; (f) infrastructure for carbon capture, and storage in industrial processes, bioenergy plants and manufacturing facilities towards the energy transition; and (g) critical infrastructure, whether physical or virtual, including infrastructure elements identified as critical as well as land and real estate crucial for the use of such critical infrastructure and the provision of goods and services instrumental to the operation and maintenance of the critical infrastructure. (2) the development of sustainable and safe transport infrastructures and mobility solutions, equipment and innovative technologies in accordance with Union transport priorities and the commitments taken under the Paris Agreement, in particular through: (a) projects that support the development of the trans-European transport network (TEN-T) infrastructure, including infrastructure maintenance and safety, the urban nodes of TEN-T, maritime and inland ports, airports, multimodal terminals and the connection of such multimodal terminals to the TEN-T networks, and the telematic applications referred to in Regulation (EU) No 1315/2013 of the European Parliament and of the Council (1); (b) TEN-T infrastructure projects that make provision for the use of at least two different modes of transport, in particular multimodal freight terminals and passenger transport hubs; (c) smart and sustainable urban mobility projects that target low-emission urban transport modes, including inland waterway solutions and innovative mobility solutions, non-discriminatory accessibility, reduced air pollution and noise, energy consumption, networks of smart cities, maintenance, and increasing safety levels and decreasing the frequency of accidents, including for cyclists and pedestrians); (d) supporting the renewal and retrofitting of transport mobile assets with the view of deploying low and zero-emission mobility solutions, including through the use of alternative fuels in vehicles of all transport modes; (e) railway infrastructure, other rail projects, inland waterway infrastructure, mass transit projects and maritime ports and motorways of the sea; (f) alternative fuel infrastructure for all modes of transport, including electric charging infrastructure; (g) other smart and sustainable mobility projects that target: (i) road safety; (ii) accessibility; (iii) emission reduction; or (iv) the development and deployment of new transport technologies and services such as services that relate to connected and autonomous modes of transport or integrated ticketing; (h) projects to maintain or upgrade existing transport infrastructure, including motorways on the TEN-T where necessary to upgrade, maintain or improve road safety, to develop Intelligent Transport Systems (ITS) services or to guarantee infrastructure integrity and standards, to develop safe parking areas and facilities, recharging and refuelling stations for alternative fuels; and (i) critical infrastructure including infrastructure elements identified as critical as well as land and real estate crucial for the use of such critical infrastructure and the provision of goods and services instrumental to the operation and maintenance of the critical infrastructure. (3) environment and resources, in particular with respect to: (a) water, including drinking water supply and sanitation, and network efficiency, leakage reduction, infrastructure for the collection and treatment of waste water, coastal infrastructure and other water-related green infrastructure; (b) waste management infrastructure; (c) projects and enterprises in the fields of environmental resource management and sustainable technologies; (d) the enhancement and restoration of ecosystems and their services including through the enhancement of nature and biodiversity by means of green and blue infrastructure projects; (e) sustainable urban, rural and coastal development; (f) climate change actions, climate adaptation and mitigation, including natural hazard disaster risk reduction; (g) projects and enterprises that implement the circular economy by integrating resource efficiency aspects in the production and product life cycle, including the sustainable supply of primary and secondary raw materials; (h) the decarbonisation of energy-intensive industries and the substantial reduction of emissions in such industries, including the demonstration of innovative low-emission technologies and their deployment; (i) the decarbonisation of the energy production and distribution chain by phasing out the use of coal and oil; and (j) projects that promote sustainable cultural heritage. (4) the development of digital connectivity infrastructure, whether physical or virtual, in particular through projects that support the deployment of very high capacity digital networks or 5G connectivity or that improve digital connectivity and access, particularly in rural areas and peripheral regions. (5) research, development and innovation, in particular through: (a) research and innovation projects that contribute to the objectives of Horizon Europe, including research infrastructure and support to academia; (b) corporate projects, including training and promoting the creation of clusters and business networks; (c) demonstration projects and programmes, as well as deployment of related infrastructures, technologies and processes; (d) collaborative research and innovation projects involving academia, research and innovation organisations and industry; public-private partnerships and civil society organisations; (e) knowledge and technology transfer; (f) research in the field of key enabling technologies (KETs) and their industrial applications, including new and advanced materials; and (g) new effective and accessible healthcare products, including research, development, innovation and manufacturing of pharmaceuticals, medical devices, diagnostics and advanced therapy medicinal products and new antimicrobials, as well as innovative development processes that avoid using animal testing. (6) the development, deployment and scaling-up of digital technologies and services, especially digital technologies and services, including media, online service platforms and secure digital communication, that contribute to the objectives of the Digital Europe Programme, in particular through: (a) artificial intelligence; (b) quantum technology; (c) cybersecurity and network protection infrastructures; (d) the internet of things; (e) blockchain and other distributed ledger technologies; (f) advanced digital skills; (g) robotics and automatisation; (h) photonics; (i) other advanced digital technologies and services contributing to the digitisation of the Union industry and the integration of digital technologies, services and skills in the transport sector of the Union; and (j) recycling and manufacturing facilities for the production of information and communication technologies components and devices in the Union. (7) financial support to entities employing up to 499 employees, with a particular focus on SMEs, and small mid-cap companies, in particular through: (a) the provision of working capital and investment; (b) the provision of risk financing from seed to expansion stages to ensure their technological leadership in innovative and sustainable sectors including by enhancing their digitisation and innovation capacity, and their global competitiveness; (c) the provision of financing for the acquisition of a business by employees or participation in the ownership of a business by employees. (8) cultural and creative sectors, cultural heritage, media, the audio-visual sector, journalism and press, in particular through the development of new technologies, the use of digital technologies and technological management of intellectual property rights. (9) tourism. (10) the rehabilitation of industrial sites (including contaminated sites) and the restoration of such sites for sustainable use. (11) sustainable agriculture, forestry, fishery, aquaculture and other elements of the wider sustainable bioeconomy. (12) social investments, including those supporting the implementation of the European Pillar of Social Rights, in particular through: (a) microfinance, ethical, social enterprise finance and social economy; (b) demand for and the supply of skills; (c) education, training and related services, including for adults; (d) social infrastructure, in particular: (i) inclusive education and training, including early childhood education and care, and related educational infrastructure and facilities, alternative childcare, student housing and digital equipment, that are accessible for all; (ii) affordable social housing (2); (iii) health and long-term care, including clinics, hospitals, primary care, home services and community-based care; (e) social innovation, including innovative social solutions and schemes aimed at promoting social impacts and outcomes in the areas referred to in points (a) to (d) and (f) to (j); (f) cultural activities with a social objective; (g) measures to promote gender equality; (h) the integration of vulnerable people, including third country nationals; (i) innovative health solutions, including e-health, health services and new care models; (j) the inclusion of and accessibility for persons with disabilities. (13) the development of the defence industry in order to contribute to the Union’s strategic autonomy, in particular through support for: (a) the Union’s defence industry supply chain, in particular through financial support to SMEs and mid-caps; (b) companies participating in disruptive innovation projects in the defence sector and closely related dual-use technologies; (c) the defence sector supply chain when participating in collaborative defence research and development projects, including those supported by the European Defence Fund; (d) infrastructure for defence research and training. (14) space, in particular in relation to the development of the space sector in line with the objectives of the Space Strategy for Europe: (a) to maximise the benefits for the Union society and economy; (b) to foster the competitiveness of space systems and technologies, addressing in particular vulnerability of supply chains; (c) to underpin space entrepreneurship, including downstream development; (d) to foster Union’s autonomy for safe and secure access to space, including dual use aspects. (15) seas and oceans, through the development of projects and enterprises in the area of the blue economy, and the Sustainable Blue Economy Finance Principles, in particular through maritime entrepreneurship and industry, renewable marine energy and circular economy. (1) Regulation (EU) No 1315/2013 of the European Parliament and of the Council of 11 December 2013 on Union guidelines for the development of the trans-European transport network and repealing Decision No 661/2010/EU (OJ L 348, 20.12.2013, p. 1). (2) Affordable social housing is to be understood as aimed at disadvantaged persons or socially less advantaged groups, who due to solvency constraints live in severe housing deprivation or are unable to obtain housing at market conditions. ANNEX III KEY PERFORMANCE AND MONITORING INDICATORS 1. Volume of financing supported by the InvestEU Fund (broken down by policy window) 1.1 Volume of operations signed 1.2 Investment mobilised 1.3 Amount of private finance mobilised 1.4 Leverage and multiplier effect achieved 2. Geographical coverage of financing supported by the InvestEU Fund (broken down by policy window, country and region at the common classification of territorial units for statistics (NUTS) 2 level) 2.1 Number of countries (Member States and third countries) covered by operations 2.2 Number of regions covered by operations 2.3 Volume of operations per country (Member State and third country) and per region 3. Impact of financing supported by the InvestEU Fund 3.1 Number of jobs created or supported 3.2 Investment supporting climate objectives and, where applicable, broken down by policy window 3.3 Investment supporting digitisation 3.4 Investment supporting industrial transition 3.5 Investment supporting just transition 3.6 Strategic investment — Number and volume of operations contributing to the provision of critical infrastructure — Number and volume of operations contributing to investment in cybersecurity, space and defence 4. Sustainable infrastructure 4.1 Energy: Additional renewable and other safe and sustainable zero and low-emission energy generation capacity installed (in megawatts (MW)) 4.2 Energy: Number of households, number of public and commercial premises with improved energy consumption classification 4.3 Energy: Estimated energy savings generated by the projects (in kilowatt-hours (kWh)) 4.4 Energy: Annual green-house gas emissions reduced/avoided in tonnes of CO2 equivalent 4.5 Energy: Volume of investment in the development, smartening and modernisation of sustainable energy infrastructure 4.6 Digital: Additional households, enterprises or public buildings with broadband access of at least 100 Mbps upgradable to gigabit speed, or number of WIFI-hotspots created 4.7 Transport: Investment mobilised, in particular in TEN-T — Number of cross-border and missing links projects (including projects relating to urban nodes, regional cross-border rail connections, multimodal platforms, maritime ports, inland ports, connections to airports and rail-road terminals of the TEN-T core and comprehensive network) — Number of projects contributing to the digitisation of transport, in particular through the deployment of European Rail Traffic Management System (ERTMS), River Information System (RIS), Intelligent Transportation System (ITS), vessel traffic monitoring and information system (VTMIS)/e-maritime services and Single European Sky ATM Research (SESAR) — Number of alternative fuel supply points built or upgraded — Number of projects contributing to the safety of transport 4.8 Environment: Investment contributing to the implementation of plans and programmes required by the Union environmental acquis relating to air quality, water, waste and nature 5. Research, innovation and digitisation 5.1 Contribution to the objective of 3 % of the Union’s gross domestic product (GDP) invested in research, development and innovation 5.2 Number of enterprises supported by size carrying out research and innovation projects 6. SMEs 6.1 Number of enterprises supported by size (micro, small, medium-sized and small mid-cap companies) 6.2 Number of enterprises supported by stage (early, growth/expansion) 6.3 Number of enterprises supported by Member State and region at NUTS 2 level 6.4 Number of enterprises supported by sectors by statistical classification of economic activities in the European Union (NACE) code 6.5 Percentage of investment volume under the SME policy window directed towards SMEs 7. Social investment and skills 7.1 Social infrastructure: Capacity and access to supported social infrastructure by sector: housing, education, health, other 7.2 Microfinance and social enterprise finance: Number of microfinance recipients and social enterprises supported 7.3 Skills: Number of individuals acquiring new skills or having their skills validated and certified: formal, education and training qualification 8. InvestEU Advisory Hub 8.1 Number of engagements of the InvestEU Advisory Hub to provide advisory support, by sector and Member State ANNEX IV THE INVESTEU PROGRAMME – PREDECESSOR INSTRUMENTS A. Equity instruments: — European Technology Facility (ETF98): Council Decision 98/347/EC of 19 May 1998 on measures of financial assistance for innovative and job-creating small and medium-sized enterprises (SMEs) - the growth and employment initiative (OJ L 155, 29.5.1998, p. 43) — Technology Transfer Pilot project (TTP): Commission decision adopting a complementary financing decision concerning the financing of actions of the activity ‘Internal market of goods and sectoral policies’ of the Directorate-General Enterprises & Industry for 2007 and adopting the framework decision concerning the financing of the preparatory action ‘The EU assuming its role in a globalised world’ and of four pilot projects ‘Erasmus young entrepreneurs’, ‘Measures to promote cooperation and partnerships between micro and SMEs’, ‘Technological Transfer’ and ‘European Destinations of excellence’ of the Directorate-General Enterprises & Industry for 2007 — European Technology Facility (ETF01): Council Decision 2000/819/EC of 20 December 2000 on a multiannual programme for enterprise and entrepreneurship, and in particular for small and medium-sized enterprises (SMEs) (2001-2005) (OJ L 333, 29.12.2000, p. 84) — Competitiveness and Innovation Programme High Growth and Innovative SME Facility (CIP GIF): Decision No 1639/2006/EC of the European Parliament and of the Council of 24 October 2006 establishing a Competitiveness and Innovation Framework Programme (2007 to 2013) (OJ L 310, 9.11.2006, p. 15) — Connecting Europe Facility (CEF): Regulation (EU) No 1316/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Connecting Europe Facility, amending Regulation (EU) No 913/2010 and repealing Regulations (EC) No 680/2007 and (EC) No 67/2010 (OJ L 348, 20.12.2013, p. 129) as amended by Regulation (EU) 2015/1017 of the European Parliament and of the Council of 25 June 2015 on the European Fund for Strategic Investments, the European Investment Advisory Hub and the European Investment Project Portal and amending Regulations (EU) No 1291/2013 and (EU) No 1316/2013 — the European Fund for Strategic Investments (OJ L 169, 1.7.2015, p. 1) — COSME Equity Facility for Growth (COSME EFG): Regulation (EU) No 1287/2013 of the European Parliament and of the Council of 11 December 2013 establishing a Programme for the Competitiveness of Enterprises and small and medium-sized enterprises (COSME) (2014 - 2020) and repealing Decision No 1639/2006/EC (OJ L 347, 20.12.2013, p. 33) — InnovFin Equity: — Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104); — Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in “Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020)” and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, p. 81); — Council Decision 2013/743/EU of 3 December 2013 establishing the specific programme implementing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decisions 2006/971/EC, 2006/972/EC, 2006/973/EC, 2006/974/EC and 2006/975/EC (OJ L 347, 20.12.2013, p. 965) — EaSI Capacity Building Investments Window: Regulation (EU) No 1296/2013 of the European Parliament and of the Council of 11 December 2013 on a European Union Programme for Employment and Social Innovation (“EaSI”) and amending Decision No 283/2010/EU establishing a European Progress Microfinance Facility for employment and social inclusion (OJ L 347, 20.12.2013, p. 238) B. Guarantee instruments: — SME Guarantee Facility ’98 (SMEG98): Council Decision 98/347/EC of 19 May 1998 on measures of financial assistance for innovative and job-creating small and medium-sized enterprises (SMEs) - the growth and employment initiative (OJ L 155, 29.5.1998, p. 43). — SME Guarantee Facility ’01 (SMEG01): Council Decision 2000/819/EC of 20 December 2000 on a multiannual programme for enterprise and entrepreneurship, and in particular for small and medium-sized enterprises (SMEs) (2001-2005) (OJ L 333, 29.12.2000, p. 84) — Competitiveness and Innovation Programme SME Guarantee Facility ’07 (CIP SMEG07): Decision No 1639/2006/EC of the European Parliament and of the Council of 24 October 2006 establishing a Competitiveness and Innovation Framework Programme (2007 to 2013) (OJ L 310, 9.11.2006, p. 15) — European Progress Microfinance Facility – Guarantee (EPMF-G): Decision No 283/2010/EU of the European Parliament and of the Council of 25 March 2010 establishing a European Progress Microfinance Facility for employment and social inclusion (OJ L 87, 7.4.2010, p. 1) — Risk Sharing Finance Facility Risk-Sharing Instrument (RSI): — Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) Statements by the Commission (OJ L 412, 30.12.2006, p. 1) — Council Decision 2006/971/EC of 19 December 2006 concerning the Specific Programme Cooperation implementing the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013) (OJ L 400, 30.12.2006, p. 86) — Council Decision 2006/974/EC of 19 December 2006 on the Specific Programme: Capacities implementing the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013) (OJ L 400, 30.12.2006, p. 299) — EaSI Guarantee Instrument: Regulation (EU) No 1296/2013 of the European Parliament and of the Council of 11 December 2013 on a European Union Programme for Employment and Social Innovation (“EaSI”) and amending Decision No 283/2010/EU establishing a European Progress Microfinance Facility for employment and social inclusion (OJ L 347, 20.12.2013, p. 238) — COSME Loan Guarantee Facility (COSME LGF): Regulation (EU) No 1287/2013 of the European Parliament and of the Council of 11 December 2013 establishing a Programme for the Competitiveness of Enterprises and small and medium-sized enterprises (COSME) (2014 - 2020) and repealing Decision No 1639/2006/EC (OJ L 347, 20.12.2013, p. 33) — InnovFin Debt: — Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in “Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020)” and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, p. 81) — Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104) — Council Decision 2013/743/EU of 3 December 2013 establishing the specific programme implementing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decisions 2006/971/EC, 2006/972/EC, 2006/973/EC, 2006/974/EC and 2006/975/EC (OJ L 347, 20.12.2013, p. 965) — Cultural and Creative Sectors Guarantee Facility (CCS GF): Regulation (EU) No 1295/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Creative Europe Programme (2014 to 2020) and repealing Decisions No 1718/2006/EC, No 1855/2006/EC and No 1041/2009/EC (OJ L 347, 20.12.2013, p. 221) — Student Loan Guarantee Facility (SLGF): Regulation (EU) No 1288/2013 of the European Parliament and of the Council of 11 December 2013 establishing “Erasmus+”: the Union programme for education, training, youth and sport and repealing Decisions No 1719/2006/EC, No 1720/2006/EC and No 1298/2008/EC (OJ L 347, 20.12.2013, p. 50) — Private Finance for Energy Efficiency (PF4EE): Regulation (EU) No 1293/2013 of the European Parliament and of the Council of 11 December 2013 on the establishment of a Programme for the Environment and Climate Action (LIFE) and repealing Regulation (EC) No 614/2007 (OJ L 347, 20.12.2013, p. 185) C. Risk-sharing instruments: — Risk Sharing Finance Facility (RSFF): Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) Statements by the Commission (OJ L 412, 30.12.2006, p. 1) — InnovFin: — Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104) — Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in “Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020)” and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, p. 81) — Connecting Europe Facility Debt Instrument (CEF DI): Regulation (EU) No 1316/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Connecting Europe Facility, amending Regulation (EU) No 913/2010 and repealing Regulations (EC) No 680/2007 and (EC) No 67/2010 (OJ L 348, 20.12.2013, p. 129) — Natural Capital Financing Facility (NCFF): Regulation (EU) No 1293/2013 of the European Parliament and of the Council of 11 December 2013 on the establishment of a Programme for the Environment and Climate Action (LIFE) and repealing Regulation (EC) No 614/2007 (OJ L 347, 20.12.2013, p. 185) D. Dedicated investment vehicles: — European Progress Microfinance Facility – Fonds commun de placement – fonds d’investissement spécialisé (EPMF FCP-FIS): Decision No 283/2010/EU of the European Parliament and of the Council of 25 March 2010 establishing a European Progress Microfinance Facility for employment and social inclusion (OJ L 87, 7.4.2010, p. 1) — Marguerite: — Regulation (EC) No 680/2007 of the European Parliament and of the Council of 20 June 2007 laying down general rules for the granting of Community financial aid in the field of the trans-European transport and energy networks (OJ L 162, 22.6.2007, p. 1) — Commission Decision C(2010)0941 of 25 February 2010 on European Union participation in the 2020 European Fund for Energy, Climate Change and Infrastructure (the Marguerite Fund) — European Energy Efficiency Fund (EEEF): Regulation (EU) No 1233/2010 of the European Parliament and of the Council of 15 December 2010 amending Regulation (EC) No 663/2009 establishing a programme to aid economic recovery by granting Community financial assistance to projects in the field of energy (OJ L 346, 30.12.2010, p. 5) ANNEX V MARKET FAILURES, SUBOPTIMAL INVESTMENT SITUATIONS, ADDITIONALITY AND EXCLUDED ACTIVITIES A. Market failures, suboptimal investment situations and additionality In accordance with Article 209 of the Financial Regulation, the EU guarantee shall address market failures or suboptimal investment situations (point (a) of Article 209(2) of the Financial Regulation) and shall achieve additionality by preventing the replacement of potential support and investment from other public or private sources (point (b) of Article 209(2) of the Financial Regulation). In order to comply with points (a) and (b) of Article 209(2) of the Financial Regulation, the financing and investment operations benefitting from the EU guarantee shall fulfil the following requirements laid down in points 1 and 2: 1. Market failures and suboptimal investment situations To address market failures or suboptimal investment situations as referred to in point (a) of Article 209(2) of the Financial Regulation, the investments targeted by the financing and investment operations shall include one of following features: (a) Have the nature of a public good for which the operator or company cannot capture sufficient financial benefits (such as education and skills, healthcare and accessibility, security and defence, and infrastructure available at no or negligible cost). (b) Externalities which the operator or company generally fails to internalise, such as R&D investment, energy efficiency, climate or environmental protection. (c) Information asymmetries, in particular in the case of SMEs and small mid-cap companies, including higher risk levels related to early stage firms, firms with mainly intangible assets or insufficient collateral, or firms focusing on higher risk activities. (d) Cross-border infrastructure projects and related services or funds that invest on a cross-border basis to address the fragmentation of the internal market and to enhance coordination within the internal market. (e) Exposure to higher levels of risks in certain sectors, countries or regions beyond levels that private financial actors are able or willing to accept, including where the investment would not have been undertaken or would not have been undertaken to the same extent because of its novelty or because of risks associated with innovation or unproven technology. (f) New or complex market failures or suboptimal investment situations in accordance with point (a)(iii) of Article 9(1) of this Regulation. 2. Additionality Financing and investment operations shall fulfil both aspects of additionality as referred to in point (b) of Article 209(2) of the Financial Regulation. That means that the operations would not have been carried out or would not have been carried out to the same extent by other public or private sources without support from the InvestEU Fund. For the purposes of this Regulation, those operations shall be understood as financing and investment operations having to meet the following two criteria: (1) to be considered additional to the private sources referred to in point (b) of Article 209(2) of the Financial Regulation, the InvestEU Fund shall support the financing and investment operations of the implementing partners by targeting investments which, due to their characteristics (public good nature, externalities, information asymmetries, socio-economic cohesion considerations or other), are unable to generate sufficient market-level financial returns or are perceived to be too risky (compared to the risk levels that the relevant private entities are willing to accept). Because of those characteristics, such financing and investment operations cannot access market financing at reasonable conditions in terms of pricing, collateral requirements, the type of finance, the tenor of financing provided or other conditions, and would not be undertaken in the Union at all or to the same extent without public support; (2) to be considered additional to existing support from other public sources referred to in point (b) of Article 209(2) of the Financial Regulation the InvestEU Fund shall only support financing and investment operations for which the following conditions apply: (a) the financing and investment operations would not have been carried out or would not have been carried out to the same extent by the implementing partner without support from the InvestEU Fund; and (b) the financing and investment operations would not have been carried out or would not have been carried out to the same extent in the Union under other existing public instruments, such as shared management financial instruments that operate at regional or national level, although the complementary use of InvestEU Fund and other public sources has to be possible, in particular where Union added value can be achieved and where the use of public sources to achieve policy objectives in an efficient manner can be optimised. To demonstrate that the financing and investment operations benefitting from the EU guarantee are additional to the existing market and to existing other public support, the implementing partners shall provide information that demonstrates the presence of at least one of the following features: (a) support through subordinated positions in relation to other public or private lenders or within the funding structure; (b) support through equity and quasi-equity or through debt with long tenors, pricing, collateral requirements or other conditions not sufficiently available on the market or from other public sources; (c) support to operations that carry a higher risk profile than the risk generally accepted by the implementing partner’s own standard activities or support to implementing partners in exceeding own capacity to support such operations; (d) participation in risk-sharing mechanisms targeting policy areas that exposes the implementing partner to higher risk levels compared to the levels generally accepted by the implementing partner or that private financial actors are able or willing to accept; (e) support that catalyses or crowds in additional private or public financing and is complementary to other private and commercial sources, in particular from traditionally risk-averse investor classes or institutional investors, as a result of the signalling effect of the support from the InvestEU Fund; (f) support through financial products not available or not offered to a sufficient level in the targeted countries or regions due to missing, underdeveloped or incomplete markets. For intermediated financing and investment operations, in particular for SME support, additionality shall be verified at the level of the intermediary rather than at the level of the final recipient. Additionality shall be deemed to exist when InvestEU Fund supports a financial intermediary in setting up a new portfolio with a higher level of risk or increasing the volume of activities that are already highly risky as compared with the risk levels that private and public financial actors are currently able or willing to accept in the targeted countries or regions. The EU guarantee shall not be granted for supporting refinancing operations (such as replacing existing loan agreements or other forms of financial support for projects which have already partially or fully materialised), except in specific exceptional and well justified circumstances in which it is demonstrated that the operation under the EU guarantee will enable a new investment in an eligible area for financing and investment operations under Annex II of an amount, additional to customary volume of activity by the implementing partner or financial intermediary, at least equivalent to the amount of the operation that fulfils the eligibility criteria set out in this Regulation. Such refinancing operations shall respect the requirements set out in Section A of this Annex regarding market failure, suboptimal investment situations and additionality. B. Excluded activities The InvestEU Fund shall not support: (1) activities which limit individual rights and freedoms or that violate human rights (2) in the area of defence activities, the use, development, or production of products and technologies that are prohibited by applicable international law (3) tobacco-related products and activities (production, distribution, processing and trade) (4) activities excluded from financing pursuant to the relevant provisions of the Horizon Europe Regulation: research on human cloning for reproductive purposes; activities intended to modify the genetic heritage of human beings which could make such changes heritable; and activities to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer (5) gambling (production-, construction-, distribution-, processing-, trade- or software-related activities) (6) sex trade and related infrastructure, services and media (7) activities involving live animals for experimental and scientific purposes insofar as compliance with the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (1) cannot be guaranteed (8) real estate development activity, such as an activity with a sole purpose of renovating and re-leasing or re-selling existing buildings as well as building new projects; however, activities in the real estate sector that are related to the specific objectives of the InvestEU Programme as specified in Article 3(2) and to the areas eligible for financing and investment operations under Annex II, such as investments in energy efficiency projects or social housing, shall be eligible (9) financial activities such as purchasing or trading in financial instruments. In particular, interventions targeting buy-out intended for asset stripping or replacement capital intended for asset stripping shall be excluded (10) activities forbidden by applicable national legislation (11) the decommissioning, operation, adaptation or construction of nuclear power stations (12) investments related to mining or to the extraction, processing, distribution, storage or combustion of solid fossil fuels and oil, as well as investments related to the extraction of gas. This exclusion does not apply to: (a) projects where there is no viable alternative technology; (b) projects related to pollution prevention and control; (c) projects equipped with carbon capture and storage or carbon capture and utilisation installations; industrial or research projects that lead to substantial reductions of greenhouse gas emissions as compared with the applicable EU Emission Trading System benchmarks (13) investments in facilities for the disposal of waste in landfill. This exclusion does not apply to investments in: (a) on-site landfill facilities that are an ancillary element of an industrial or mining investment project and where it has been demonstrated that landfilling is the only viable option to treat the industrial or mining waste produced by the activity concerned itself; (b) existing landfill facilities to ensure the utilisation of landfill gas and to promote landfill mining and the reprocessing of mining waste (14) investments in mechanical biological treatment (MBT) plants. This exclusion does not apply to investments to retrofit existing MBT plants for waste-to-energy purposes or recycling operations of separated waste such as composting and anaerobic digestion (15) investments in incinerators for the treatment of waste. This exclusion does not apply to investments in: (a) plants exclusively dedicated to treating non-recyclable hazardous waste; (b) existing plants, where the investment is for the purpose of increasing energy efficiency, capturing exhaust gases for storage or use or recovering materials from incineration ashes, provided such investments do not result in an increase of the plants’ waste processing capacity. The implementing partners shall remain responsible for ensuring compliance of financing and investment operations with the exclusion criteria set out in this Annex at signature of the relevant agreement, for monitoring such compliance during the implementation of the project and for undertaking appropriate remedial actions where relevant. (1) OJ L 222, 24.8.1999, p. 31.

InvestEU Programme (2021-2027) InvestEU Programme (2021-2027) SUMMARY OF: Regulation (EU) 2021/523 establishing the InvestEU Programme WHAT IS THE AIM OF THE REGULATION? It establishes the InvestEU programme comprising 3 building blocks: the InvestEU Fund, providing an EU guarantee to support financing of and investment in internal EU policies; the InvestEU Advisory Hub, supporting project development, access to finance and capacity-building assistance; the InvestEU Portal, giving visibility to projects seeking finance and information on investment opportunities. KEY POINTS The InvestEU programme’s general aim is to support financing that contributes to: competitiveness, including research, innovation and digitisation; economic growth, sustainability and employment; social resilience, inclusiveness and innovation; scientific and technological advancement, including culture, education and training; the integration of capital markets and a stronger internal market; economic, social and territorial cohesion; sustainable and inclusive recovery of the EU economy, including capital support for small and medium-sized enterprises (SMEs), after the Covid-19 crisis. The programme uses 4 specific policy areas (through 4 dedicated ‘windows’), each with specific EU and national parts (‘compartments’) to address market failures or suboptimal investment situations: sustainable infrastructure ranging from transport, energy and digital connectivity to the circular economy and innovative technologies; research, innovation and digitisation, including product development and support for market enablers; financing for SMEs, including innovative companies and those in the cultural and creative sectors; social investment and skills covering microfinance, social enterprises, health, gender equality, education, training and other social services. These are supported by: a just transition scheme with investments to address the social, economic and environmental challenges of meeting the EU’s 2030 climate targets and 2050 goal of climate neutrality (see summary); strategic investments in important projects of common European interest, such as defence, space, cybersecurity, the green transition, the digital transition and strengthening strategic value chains. InvestEU has a budgetary guarantee of €26.2 billion (in current prices) funded by NextGenerationEU resources and the multiannual financial framework (2021-2027). The guarantee can be increased by contributions from EU Member States and non-EU countries. It is split as follows: €14.8 billion for measures to support the post-Covid-19 economic recovery under the EU’s Recovery and Resilience Facility set up under Regulation (EU) 2021/241 (see summary); €11.3 billion for the 4 specific policy areas listed above. The European Commission and the European Investment Bank Group (EIBG) form a partnership under which the EIBG has specific tasks, to: support the implementation of the InvestEU programme; foster its consistency, inclusivity, additionality* and efficient deployment. Other national promotional banks and institutions and international financial institutions can take part in the programme. The Commission will: select implementing partners* in addition to the EIB; conclude a guarantee agreement with each partner covering items such as the amount and terms of the financial contribution, payment conditions and key performance indicators. To qualify for InvestEU Fund support, financing and investment operations must: comply with various conditions set out in the EU’s Financial Regulation (Regulation (EU, Euratom) 2018/1046 — see summary); contribute to the EU’s policy objectives and be an eligible area under Annex II (energy, transport infrastructure, environment and resources, digital connectivity, research, development and innovation, digital technologies, SMEs, cultural and creative sectors, tourism, rehabilitation of industrial sites, sustainable land and water use, bioeconomy, social investment, defence, space, seas and oceans); not feature on the list of excluded activities in Annex V (B), such as gambling, tobacco, real estate, oil, fossil fuels or violations of human rights; be consistent with the investment guidelines. The InvestEU Fund may also support projects and operations in non-EU countries subject to certain conditions. The EU guarantee: may be used towards risk coverage for various types of financing (loans, guarantees, capital market instruments or other forms of credit) provided by the implementing partners; covers for debt: all outstanding principal and interest due to the implementing partner, restructuring losses and losses from currency fluctuations, apart from the euroequity or quasi-equity investments: amounts invested and associated funding costs and losses from currency fluctuations, apart from the eurofunding or guarantees by an implementing partner to another financial institution: amounts used and associated costs. The regulation establishes a governance structure which consists of the following. The Advisory Board meets at least twice a year and advises the Commission and the Steering Board on the design of financial products, market developments, conditions and failures and suboptimal investments. The Steering Board provides strategic and operational guidance for the implementing partners, applies the Commission’s risk methodological framework and oversees the implementation of the InvestEU programme. The Scoreboard contains various indicators that implementing partners provide, such as a description of the proposed financing and impact of the investment, so the Investment Committee can carry out an independent, transparent and harmonised assessment of requests for use of the EU guarantee. The Investment Committee is a fully independent body of experts that examines the financing and investment proposals submitted under the 4 ‘windows’ and checks whether they meet the regulation’s conditions and whether they would benefit from support under the EU guarantee. Policy checks are carried out by the Commission to confirm proposed financing and investment operations from implementing partners, apart from the EIB, comply with EU law and policies. The InvestEU Advisory Hub, established by the Commission: provides advisory support to identify, prepare, develop, structure, procure and implement investment projects; helps project promoters and intermediaries to implement their financing and investment activities; acts as a central point of entry, managed by the Commission, for project development assistance for public authorities and project promoters, including additional information on investment guidelines; is available to public and private project promoters, including SMEs and start-ups, public authorities, national promotional banks and institutions and financial and non-financial intermediaries. The InvestEU Portal, established by the Commission: is an easily accessible and user-friendly database providing relevant information for each project; provides a channel for promoters seeking finance to make their projects visible to potential investors. The regulation establishes accountability, monitoring, evaluation and transparency requirements as follows. Accountability. The European Parliament or the Council may ask the Chairperson of the Steering Board to report on the InvestEU Fund’s performance and reply orally or in writing to questions. Monitoring and reporting. Annex III contains a detailed list of key performance and monitoring indicators. Implementing partners use these in their 6-monthly reports to the Commission, which in turn reports annually on the InvestEU programme’s performance. The EIB reports annually on investment barriers. Evaluation. The Commission: will submit an interim evaluation report on the programme to the European Parliament and the Council by 30 September 2024will present the 2 institutions with its final evaluation report, in particular on use of the EU guarantee, by 31 December 2031 at the latest. It will also send its conclusions to the European Economic and Social Committee and the European Committee of the Regions. Transparency. Implementing and advisory partners must acknowledge EU funding by providing targeted information to multiple audiences, including the media and the public. The Commission organises information and communication activities. The regulation: gives the Commission the power to adopt delegated acts; amends Regulation (EU) 2015/1017 on the European Fund for Strategic Investments (see summary). FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND The InvestEU programme brings under one umbrella many different forms of EU financing. This makes funding for investment projects simpler, more efficient and more flexible and helps meet the EU’s twin goals of a green transition and digital transformation. The EU guarantee is used to leverage substantial private and public long-term funds to contribute to Europe’s economic and social recovery by aligning investors with EU policy priorities. Member States may use InvestEU to implement their national plans under the Recovery and Resilience Facility. It is estimated the guarantee could mobilise total investment across the EU of over €372 billion by 2027, of which 30% will go towards climate policies. The InvestEU programme builds on the successful model of the investment plan for Europe, known as the Juncker Plan, which mobilised more than €500 billion between 2015 and 2020. For more information, see: InvestEU (European Commission). KEY TERMS Additionality: under EFSI (the European Fund for Strategic Investments), this term means support for operations which address market failures or suboptimal investment situations and which could not have been carried out in the period during which the EU guarantee can be used, or not to the same extent, by the EIB Group or under existing EU financial instruments without EFSI support. Implementing partner: an eligible counterpart, such as a national or international financial institution or promotional bank with whom the Commission has concluded an agreement. MAIN DOCUMENT Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, pp. 30-89) RELATED DOCUMENTS Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, pp. 17-75) Commission Delegated Regulation (EU) 2021/1078 of 14 April 2021 supplementing Regulation (EU) 2021/523 of the European Parliament and of the Council by setting out the investment guidelines for the InvestEU Fund (OJ L 234, 2.7.2021, pp. 18-66) Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions — The European Green Deal (COM(2019) 640 final, 11.12.2019) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, pp. 1-222) Regulation (EU) 2015/1017 of the European Parliament and of the Council of 25 June 2015 on the European Fund for Strategic Investments, the European Investment Advisory Hub and the European Investment Project Portal and amending Regulations (EU) No 1291/2013 and (EU) No 1316/2013 — the European Fund for Strategic Investments (OJ L 169, 1.7.2015, pp. 1-38) Successive amendments to Regulation (EU) 2015/1017 have been incorporated into the original text. This consolidated version is of documentary value only. last update 09.06.2021

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12.5.2021 EN Official Journal of the European Union L 170/1 REGULATION (EU) 2021/695 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 173(3), Article 182(1), Article 183, and the second paragraph of Article 188 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinions of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) It is an objective of the Union to strengthen its scientific and technological bases by strengthening the European research area (ERA) in which researchers, scientific knowledge and technology circulate freely and encouraging it to become more competitive, including in its industry, while promoting all research and innovation (R&I) activities to deliver on the Union's strategic priorities and commitments, which ultimately aim to promote peace, the Union's values and the well-being of its peoples. (2) To deliver scientific, technological, economic, environmental and societal impact in pursuit of this general objective and to maximise the added value of the Union's R&I investments, the Union should invest in R&I through Horizon Europe - the Framework Programme for Research and Innovation 2021-2027 (the 'Programme'). The Programme should support the creation, better diffusion and transfer of high-quality and excellent knowledge and high-quality technologies in the Union, attract talent at all levels and contribute to full engagement of the Union's talent pool, facilitate collaborative links and strengthen the impact of R&I in developing, supporting and implementing Union policies, support and strengthen the uptake and deployment of innovative and sustainable solutions in the Union's economy, in particular in small and medium-sized enterprises (SMEs), and in society, address global challenges, including climate change and the United Nations Sustainable Development Goals (SDGs), create jobs, boost economic growth, promote industrial competitiveness and boost the attractiveness of the Union in the field of R&I. The Programme should foster all forms of innovation, including breakthrough innovation, foster market deployment of innovative solutions, and optimise the delivery of such investment for increased impact within a strengthened ERA. (3) The Programme should be established for the duration of the multiannual financial framework (MFF) 2021-2027 as laid down in Council Regulation (EU, Euratom) 2020/2093 (4), without prejudice to the time limits set out in Council Regulation (EU) 2020/2094 (5). (4) The Programme should contribute to increasing public and private investment in R&I in Member States, thereby helping to reach an overall investment target of at least 3 % of the Union's gross domestic product (GDP) in research and development. Achieving that target would require Member States and the private sector to complement the Programme with their own reinforced investment actions in research, development and innovation. (5) With a view to achieving the objectives of the Programme and while respecting the principle of excellence, the Programme should aim to strengthen, among other things, collaborative links in Europe thereby contributing to reducing the R&I divide. (6) To help achieve Union policy objectives, activities supported under this Programme should, where relevant, take advantage of and inspire innovation-friendly regulation, in line with the innovation principle, to support a faster and more intensive transformation of the Union's substantial knowledge assets into innovation. (7) The concepts of 'open science', 'open innovation' and 'open to the world' should ensure excellence and the impact of the Union's investment in R&I, while safeguarding the Union's interests. (8) Open science, including open access to scientific publications and research data, as well as optimal dissemination and exploitation of knowledge have the potential to increase the quality, impact and benefits of science. They also have the potential to accelerate the advancement of knowledge by making it more reliable, efficient and accurate, more easily understood by society and responsive to societal challenges. Provisions should be laid down to ensure that beneficiaries provide open access to peer-reviewed scientific publications. Likewise, it should be ensured that beneficiaries provide open access to research data following the principle 'as open as possible, as closed as necessary', while ensuring the possibility of exceptions taking into account the legitimate interests of the beneficiaries. More emphasis should in particular be given to the responsible management of research data, which should comply with the principles of 'findability', 'accessibility', 'interoperability' and 'reusability' (the 'FAIR principles'), in particular through the mainstreaming of data management plans. Where appropriate, beneficiaries should make use of the possibilities offered by the European Open Science Cloud (EOSC) and the European Data Infrastructure and adhere to further open science principles and practices. Reciprocity in open science should be encouraged in all association and cooperation agreements with third countries. (9) Beneficiaries of the Programme, especially SMEs, are to be encouraged to make use of the relevant existing Union's instruments, such as the European IP Helpdesk that supports SMEs and other participants in the Programme in both protecting and enforcing their intellectual property (IP) rights. (10) The conception and design of the Programme should respond to the need for establishing a critical mass of supported activities throughout the Union, encouraging excellence-based participation of all Member States, and through international cooperation, in line with the 2030 Agenda for Sustainable Development (the '2030 Agenda'), the SDGs and the Paris Agreement adopted under the United Nations Framework Convention on Climate Change (6) (the 'Paris Agreement'). Programme implementation should reinforce the pursuit of the SDGs and the commitment of the Union and its Member States to implementing the 2030 Agenda to achieving its three dimensions – economic, social and environmental – in a coherent and integrated manner. (11) Activities supported under the Programme should contribute towards the achievement of the Union's objectives, priorities and international commitments. (12) The Programme should benefit from complementarity with existing relevant European R&I roadmaps and strategies, as well as with important projects of common European interest (IPCEIs), where relevant, provided that related R&I needs are identified in the Programme's strategic planning. (13) The Programme should ensure transparency and accountability of public funding in R&I projects, thereby preserving the public interest. (14) The Programme should support R&I activities in the field of social sciences and humanities (SSH). This entails advancing scientific knowledge in that domain and making use of insights and progress from SSH to increase the economic and societal impact of the Programme. Under the pillar 'Global Challenges and European Industrial Competitiveness', SSH should be fully integrated across all clusters. Beyond the promotion of SSH in projects, the integration of SSH should also be supported through the inclusion, whenever appropriate, of independent external experts from the field of SSH in expert committees and evaluation panels, and through timely monitoring and reporting of SSH in funded research actions. In particular, the level of mainstreaming of SSH should be monitored across the Programme. (15) The Programme should maintain a balanced approach between research on the one hand and innovation on the other, as well as between bottom-up funding (investigator or innovator driven) and top-down funding (determined by strategically defined priorities), by reference to the nature of the R&I communities that are engaged across the Union, the types and purpose of the activities carried out and the impacts that are sought. The mix of those factors should determine the choice of approach for the relevant parts of the Programme, all of which contribute to all general and specific objectives of the Programme. (16) The overall budget for the 'widening participation and spreading excellence' component of the 'Widening Participation and Strengthening the ERA' part of the Programme should be at least 3,3 % of the overall Programme budget and should mainly benefit legal entities established in the widening countries. (17) Excellence initiatives should aim to strengthen R&I excellence in the eligible countries, including supporting training to improve R&I managerial skills, prizes, strengthening innovation ecosystems as well as the creation of R&I networks, including on the basis of research infrastructures financed by the Union. Applicants should clearly show that projects are linked with national and/or regional R&I strategies to be eligible to apply for funding under the 'widening participation and spreading excellence' component of the 'Widening Participation and Strengthening the ERA' part of the Programme. (18) It should be possible to apply a fast track to R&I procedure, where time-to-grant should not exceed six months, to allow for faster, bottom-up access to funds for small collaborative consortia covering actions from fundamental research to market application. (19) The Programme should support all stages of R&I especially within collaborative projects and in missions and European Partnerships, as appropriate. Fundamental research is an essential asset of and an important condition for increasing the Union's ability to attract the best scientists in order to become a global hub of excellence. A balance between basic and applied research should be ensured in the Programme. Coupled with innovation, that balance will support the Union's economic competitiveness, growth and jobs. (20) Evidence shows that embracing diversity, in all senses, is key to doing good science, as science benefits from diversity. Diversity and inclusiveness contribute to excellence in collaborative R&I: collaboration across disciplines, sectors and throughout the ERA makes for better research and higher quality project proposals, can lead to higher rates of societal take-up and can foster the benefits of innovation, thus advancing Europe. (21) In order to maximise the impact of the Programme, particular consideration should be given to multidisciplinary, interdisciplinary and transdisciplinary approaches as key elements for major scientific progress. (22) Research activities carried out under the pillar 'Excellent Science' should be determined according to the needs and opportunities of science and should promote scientific excellence. The research agenda should be set in close liaison with the scientific community and include emphasis on attracting new R&I talents, early stage researchers, while strengthening the ERA, avoiding brain drain and promoting brain circulation. (23) The Programme should support the Union and its Member States in attracting the best talents and skills, taking into account the reality of very intense international competition. (24) The pillar 'Global Challenges and European Industrial Competitiveness' should be established through clusters of R&I activities, in order to maximise integration across the respective thematic areas while securing high and sustainable levels of impact for the Union in relation to the resources that are expended. It would encourage cross-disciplinary, cross-sectoral, cross-policy and cross-border collaboration in pursuit of the SDGs by following the principles of the 2030 Agenda, the Paris Agreement and the competitiveness of the Union's industries. The organisation of high-ambition, wide-scale initiatives in the form of R&I missions would enable the Programme to achieve a transformative and systemic impact for society in support of the SDGs, also through international cooperation and science diplomacy. The activities under that pillar should cover the full range of R&I activities to ensure that the Union remains at the cutting-edge in strategically defined priorities. (25) The cluster 'Culture, Creativity and Inclusive Society' should contribute substantially to the research on cultural and creative sectors, including on the Union's cultural heritage and in particular allowing the establishment of a European cultural heritage collaborative space. (26) Full and timely engagement of all types of industry in the Programme, from individual entrepreneurs and SMEs to large scale enterprises, would substantially contribute to the realisation of the objectives of the Programme and specifically towards the creation of sustainable jobs and growth in the Union. Such engagement by the industry should see its participation in the actions supported at levels at least commensurate with those under the framework programme Horizon 2020 established by Regulation (EU) No 1291/2013 of the European Parliament and of the Council (7) (Horizon 2020). (27) Actions under the Programme would substantially contribute towards unlocking the potential of the Union's strategic sectors, including key enabling technologies that reflect the Union's industrial policy strategy objectives. (28) Multi-stakeholder consultations, including of civil society and industry, should contribute to the perspectives and priorities established through the strategic planning. This should result in periodic strategic R&I plans adopted by means of implementing acts for preparing the content of work programmes. (29) For a particular action to be funded, the work programme should take into account the outcome of specific previous projects as well as the state of science, technology and innovation at national, Union and international level and of the relevant policy, market and societal developments. (30) It is important to support the Union's industry in remaining or in becoming a world leader in innovation, digitisation and climate neutrality, in particular through investments in key enabling technologies that will underpin tomorrow's business. The Programme's actions should address market failures or sub-optimal investment situations, boost investments in a proportionate and transparent manner, without duplicating or crowding out private financing and have a clear European added value and public return on investments. This will ensure consistency between the actions of the Programme and Union State aid rules, in order to incentivise innovation and avoid undue distortions of competition in the internal market. (31) The Programme should support R&I in an integrated manner, respecting all relevant provisions in the framework of the World Trade Organization. The concept of research, including experimental development, should be used in accordance with the Frascati Manual developed by the Organisation for Economic Co-operation and Development (OECD), whereas the concept of innovation should be used in accordance with the Oslo Manual developed by the OECD and Eurostat, which follows a broad approach that covers social innovation and design. As in Horizon 2020, the OECD definitions regarding technological readiness levels (TRLs) should continue to be taken into account in the classification of technological research, product development and demonstration activities, and in the definition of types of action available in calls for proposals. Grants should not be awarded for actions where activities go above TRL 8. It should be possible for the work programme to allow grants for large-scale product validation and market replication for a given call under the pillar 'Global Challenges and European Industrial Competitiveness'. (32) The Programme should contribute to space objectives at a level of spending that is at least proportionally commensurate with that under Horizon 2020. (33) The Commission communication of 11 January 2018 entitled 'Horizon 2020 interim evaluation: maximising the impact of EU research and innovation', the resolution of the European Parliament of 13 June 2017 on the assessment of Horizon 2020 implementation in view of its interim evaluation and the Framework Programme 9 proposal (8) and the Council Conclusions of 1 December 2017 entitled 'From the Interim Evaluation of Horizon 2020 towards the ninth Framework Programme' have provided a set of recommendations for the Programme, including for its rules for participation and dissemination. Those recommendations build on the lessons learnt from Horizon 2020 as well as input from Union institutions and stakeholders. Those recommendations include the proposal of measures to promote brain circulation and facilitate openness of R&I networks to invest more ambitiously in order to reach critical mass and maximise impact; to support breakthrough innovation; to prioritise Union R&I investments in areas of high added value, in particular through mission-orientation, full, well-informed and timely citizen involvement and wide communication; to rationalise the Union funding landscape in order to fully use the R&I potential, including research infrastructures across the Union, such as by streamlining the range of European Partnership initiatives and co-funding schemes; to develop more and concrete synergies between different Union funding instruments, in particular by overcoming non-complementary intervention logics and complexity of the various funding and other regulations also with the aim of helping to mobilise under-exploited R&I potential across the Union; to strengthen international cooperation and reinforce openness to third countries' participation; and to continue simplification based on implementation experiences of Horizon 2020. (34) Given that special attention needs to be paid to coordination and complementarity between different Union policies, the Programme should seek synergies with other Union programmes, from their design and strategic planning, to project selection, management, communication, dissemination and exploitation of results, monitoring, auditing and governance. Regarding funding for R&I activities, synergies should allow for the harmonisation of rules, including cost eligibility rules, as much as possible. With a view to avoiding duplication or overlaps, to increasing the leverage of Union funding and to decreasing the administrative burden for applicants and beneficiaries, it should be possible to promote synergies, in particular by alternative, combined, cumulative funding and transfers of resources. (35) In accordance with Regulation (EU) 2020/2094 and within the limits of the resources allocated therein, recovery and resilience measures under the Programme should be carried out to address the unprecedented consequences of the COVID-19 crisis. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation (EU) 2020/2094. Such additional resources should be allocated exclusively to actions for R&I directed at addressing the consequences of the COVID-19 crisis and in particular its economic, social and societal consequences. (36) In order for Union funding to have the greatest possible impact and to make the most effective contribution to the Union's policy objectives and commitments, it should be possible for the Union to enter into European Partnerships with private and/or public sector partners. Such partners include industry, SMEs, universities, research organisations, R&I stakeholders, bodies with a public service mission at local, regional, national or international level or civil society organisations, including foundations and non-governmental organisations (NGOs) that support and/or carry out R&I, provided that the desired impacts can be achieved more effectively in partnership than by the Union alone. (37) It should be possible, depending on the Member State's decision, that the contributions from programmes co-financed by the European Regional Development Fund (ERDF), the European Social Fund Plus (ESF+), the European Maritime, Fisheries and Aquaculture Fund (EMFAF) and the European Agricultural Fund for Rural Development (EAFRD) be considered to be a contribution of the participating Member State to European Partnerships under the Programme. However, that possibility should be without prejudice to the need to comply with all provisions applicable to those contributions as set out in a Regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (the 'Common Provisions Regulation for 2021-2027') and the fund-specific regulations. (38) The Programme should strengthen cooperation between European Partnerships and private and/or public sector partners at international level, including by joining up R&I programmes and cross-border investment in R&I bringing mutual benefits to people and businesses while ensuring that the Union can uphold its interests in strategic areas. (39) Future Emerging Technologies (FET) Flagships have proven to be an effective and efficient instrument, delivering benefits for society in a joint, coordinated effort by the Union and its Member States. Activities carried out within the FET Flagships on Graphene, the Human Brain Project and Quantum Technology, which are supported under Horizon 2020, will continue to be supported under the Programme through calls for proposals included in the work programme. Preparatory actions supported under the FET Flagships part of Horizon 2020 will feed the strategic planning under the Programme and inform the work on missions, co-funded and/or co-programmed European Partnerships and regular calls for proposals. (40) The Joint Research Centre (JRC) should continue to provide independent customer-driven scientific evidence and technical support for Union policies throughout the whole policy cycle. The direct actions of the JRC should be implemented in a flexible, efficient and transparent manner, taking into account the needs of Union policies and the relevant needs of the users of the JRC and ensuring the protection of the Union's financial interests. The JRC should continue to generate additional resources. (41) The pillar 'Innovative Europe' should establish a series of measures for the provision of integrated support to respond to the needs of entrepreneurs and entrepreneurship aiming to realise and accelerate breakthrough innovation for rapid market growth as well as to promote the Union's strategic autonomy while preserving an open economy. It should provide a one-stop shop to attract and support all types of innovators and innovative companies, such as SMEs, including start-ups, and, in exceptional cases, small mid-caps, with potential for scaling up at Union and international level. The pillar should offer fast, flexible grants and co-investments, including with private investors. Those objectives should be pursued through the creation of a European Innovation Council (EIC). The pillar should also support the European Institute of Innovation and Technology (EIT) and European innovation ecosystems at large, in particular through European Partnerships with national and regional innovation support actors. (42) For the purpose of this Regulation and in particular for the activities carried out under the EIC, a 'start-up' should be understood as an SME in the early stage of its life cycle, including those that are created as spin-offs from university research activities, which aims to find innovative solutions and scalable business models, and which is autonomous within the meaning of Article 3 of the Annex to Commission Recommendation 2003/361/EC (9); a 'mid-cap' should be understood as an enterprise that is not an SME and that has between 250 and 3 000 employees, where the staff headcount is calculated in accordance with Articles 3 to 6 of Title I of the Annex to that Recommendation; and a 'small mid-cap' should be understood as a mid-cap that has up to 499 employees. (43) The policy objectives of the Programme are to be addressed also through financial instruments and budgetary guarantee of the InvestEU Programme, thereby promoting synergies between the two programmes. (44) The EIC, together with other components of the Programme, should stimulate all forms of innovation, ranging from incremental to breakthrough and disruptive innovation, targeting especially market-creating innovation. Through its Pathfinder and Accelerator instruments, the EIC should aim to identify, develop and deploy high-risk innovations of all kinds, including incremental innovations, with a main focus on breakthrough, disruptive and deep-tech innovations that have the potential to become market-creating innovations. Through coherent and streamlined support, the EIC should fill the current vacuum in public support and private investment for breakthrough innovation. The instruments of the EIC require dedicated legal and management features in order to reflect its objectives, in particular market deployment action. (45) The Accelerator is intended to bridge the 'valley of death' between research, pre-mass commercialisation and the scaling-up of companies. The Accelerator will provide support to high-potential operations presenting such technological, scientific, financial, management or market risks that they are not yet considered to be bankable and therefore cannot raise significant investments from the market, hence complementing the InvestEU Programme. (46) In close synergy with the InvestEU Programme, the Accelerator, in its blended finance and equity financial support forms, should finance projects run by SMEs, including start-ups, and, in exceptional cases, small mid-caps, which are either not yet able to generate revenues, or not yet profitable, or not yet able to attract sufficient investment to implement fully their projects' business plan. Such eligible entities would be considered to be non-bankable, while a part of their investment needs could have been or could be provided by one or several investors, such as a private or public bank, a family office, a venture capital fund or a business angel. In that way the Accelerator is intended to overcome a market failure and finance promising, but not yet bankable entities engaged in breakthrough market-creating innovation projects. Once they become bankable, those projects could be financed under the InvestEU Programme. (47) While the Accelerator budget should be mainly distributed through blended finance, for the purpose of Article 48, its grant-only support to SMEs, including start-ups, should correspond to that under the SME instrument budget of Horizon 2020. (48) The EIT, primarily through its Knowledge and Innovation Communities (KICs) and by expanding its Regional Innovation Scheme, should aim to strengthen innovation ecosystems that tackle global challenges. This should be achieved by fostering the integration of innovation, research, higher education and entrepreneurship. In accordance with a Regulation of the European Parliament and of the Council on the European Institute of Innovation and Technology (the 'EIT Regulation') and its Strategic Innovation Agenda as referred to in a Decision of the European Parliament and of the Council on the Strategic Innovation Agenda of the European Institute of Innovation and Technology (EIT) 2021-2027 the EIT should foster innovation through its activities and should significantly step up its support to the integration of higher education within the innovation ecosystem, in particular by stimulating entrepreneurial education, fostering strong non-disciplinary collaboration between industry and academia, and identifying prospective skills for future innovators to address global challenges, which include advanced digital and innovation skills. Support schemes provided by the EIT should benefit EIC beneficiaries, while start-ups emerging from the EIT's KICs should have simplified and thereby faster access to EIC actions. While the EIT's focus on innovation ecosystems should make it naturally fit within the pillar 'Innovative Europe', it should also support the other pillars, as appropriate. Unnecessary duplication between KICs and other instruments in the same field, in particular other European Partnerships, should be avoided. (49) A level playing field for competing companies in a given market should be ensured and preserved, since it is a key requirement for all types of innovation, including breakthrough, disruptive and incremental innovation, to flourish thereby enabling in particular a large number of small and medium-size innovators to build-up their R&I capacity, to reap the benefits of their investment and to capture a share of the market. (50) The Programme should promote and integrate cooperation with third countries and international organisations and initiatives based on the Union's interests, mutual benefits, international commitments, science diplomacy and, as far as possible, reciprocity. International cooperation should aim to strengthen the Union's excellence in R&I, attractiveness, capacity to retain best talents and economic and industrial competitiveness, to tackle global challenges including the SDGs by following the principles of the 2030 Agenda and the Paris Agreement, and to support the Union's external policies. An approach of general openness to international participation and targeted international cooperation actions should be followed, including through appropriate eligibility for funding of entities established in low to middle-income countries. The Union should aim to conclude international cooperation agreements in the field of R&I with third countries. At the same time, association of third countries, in particular for collaborative parts to the Programme, should be promoted, in accordance with association agreements and focusing on added value for the Union. When allocating associated countries' financial contributions to the Programme, the Commission should take into account the level of participation of legal entities of those third countries in the different parts of the Programme. (51) With the aim of deepening the relationship between science and society and maximising the benefits of their interactions, the Programme should engage and involve all societal actors, such as citizens and civil society organisations, in co-designing and co-creating responsible research and innovation (RRI) agendas, content and throughout processes that address citizens' and civil society's concerns, needs and expectations, promoting science education, making scientific knowledge publicly accessible, and facilitating participation by citizens and civil society organisations in its activities. This should be done across the Programme and through dedicated activities in the part 'Widening Participation and Strengthening the ERA'. The engagement of citizens and civil society in R&I should be coupled with public outreach activities to generate and sustain public support for the Programme. The Programme should also seek to remove barriers and boost synergies between science, technology, culture and the arts to obtain a new quality of sustainable innovation. The measures taken to improve the involvement of citizens and civil society in the supported projects should be monitored. (52) Where appropriate, the Programme should take into account the specific characteristics of the outermost regions as identified in Article 349 of the Treaty on the Functioning of the European Union (TFEU) and in line with the Commission's communication of 24 October 2017 entitled 'A stronger and renewed strategic partnership with the EU's outermost regions', as welcomed by the Council. (53) The activities developed under the Programme should aim to eliminate gender bias and inequalities, enhancing work-life balance and promoting equality between women and men in R&I, including the principle of equal pay without discrimination based on sex, in accordance with Articles 2 and 3 of the Treaty on European Union (TEU) and Articles 8 and 157 TFEU. The gender dimension should be integrated in R&I content and followed through at all stages of the research cycle. In addition, the activities under the Programme should aim to eliminate inequalities and promote equality and diversity in all aspects of R&I with regard to age, disability, race and ethnicity, religion or belief, and sexual orientation. (54) In light of the specificities of the defence industry sector, the detailed provisions for Union funding to defence research projects should be fixed in Regulation (EU) 2021/697 of the European Parliament and of the Council (10) (the 'European Defence Fund') which defines the rules of participation for defence research. Activities to be carried out under the European Defence Fund should have an exclusive focus on defence research and development, while activities carried out under the specific programme established by Council Decision (EU) 2021/764 (11) (the 'specific programme') and the EIT should have an exclusive focus on civil applications. Unnecessary duplication should be avoided. (55) This Regulation lays down a financial envelope for the entire duration of the Programme which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (12), for the European Parliament and the Council during the annual budgetary procedure. That financial envelope comprises an amount of EUR 580 000 000 in current prices for the specific programme established by Decision (EU) 2021/764 and for the EIT, in line with the joint declaration by the European Parliament, Council and Commission of 16 December 2020 on the reinforcement of specific programmes and adaptation of basic acts (13). (56) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (14) (the 'Financial Regulation') applies to this Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (57) In accordance with Article 193(2) of the Financial Regulation, a grant may be awarded for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to signature of the grant agreement. However, the costs incurred prior to the date of submission of the grant application are not eligible, except in duly justified exceptional cases. In order to avoid any disruption in Union support which could be prejudicial to Union's interests, it should be possible to provide in the financing decision, during a limited period of time at the beginning of the MFF 2021-2027, and only in duly justified cases, for eligibility of activities and costs from the beginning of the 2021 financial year, even if they were implemented and incurred before the grant application was submitted. (58) Continually throughout the Programme, administrative simplification should be sought, in particular the reduction of the administrative burden for beneficiaries. The Commission should further simplify its tools and guidance in such a way that they impose a minimal burden on beneficiaries. In particular, the Commission should consider issuing an abridged version of the guidance. (59) The completion of the Digital Single Market and the growing opportunities from the convergence of digital and physical technologies require investments to be increased. The Programme should contribute to those efforts with a substantial increase in spending on main digital R&I activities compared to Horizon 2020 (15). This should ensure that Europe remains at the forefront of global R&I in the digital field. (60) Quantum research under the 'Digital, Industry and Space' cluster under Pillar II should be prioritised, given its crucial role in the digital transition, namely by expanding the European scientific leadership and excellence in quantum technologies, enabling the envisaged budget set in 2018 to be achieved. (61) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (16) and Council Regulations (EC, Euratom) No 2988/95 (17), (Euratom, EC) No 2185/96 (18) and (EU) 2017/1939 (19), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used, and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor's Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (20). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of Union funds grant equivalent rights. (62) Third countries which are members of the European Economic Area (EEA) may participate in Union programmes in the framework of the cooperation established under the Agreement on the European Economic Area (21), which provides for the implementation of the programmes on the basis of a decision adopted under that Agreement. Third countries may also participate on the basis of other legal instruments. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. (63) Pursuant to Article 94 of Council Decision 2013/755/EU (22), persons and entities established in overseas countries or territories are eligible for funding subject to the rules and objectives of the Programme and possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. (64) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 for Better Law-Making (23), this Programme should be evaluated on the basis of information collected in accordance with specific reporting and monitoring requirements, while avoiding overregulation and an administrative burden, in particular on the Member States and the beneficiaries of the Programme. Those requirements, where appropriate, should include measurable indicators as a basis for evaluating the effects of the Programme on the ground. (65) In order to ensure the effective assessment of the Programme's progress towards the achievement of its objectives, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annex V with regard to the impact pathway indicators, where considered to be necessary, and to set baselines and targets as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (66) Coherence and synergies between the Programme and the Union Space Programme will foster a globally competitive and innovative European space sector, reinforce Europe's autonomy in accessing and using space in a secure and safe environment and strengthen Europe's role as a global actor. Excellence in research, breakthrough solutions and downstream users in the Programme will be supported by data and services made available by the Union Space Programme. (67) Coherence and synergies between the Programme and Erasmus+ will foster the uptake of research results through training activities, diffuse innovation spirit to the education system and ensure that education and training activities rely on the most updated R&I activities. In that regard, following the pilot actions launched under Erasmus+ 2014-2020 concerning European Universities, the Programme will, where appropriate, complement in a synergetic way the support provided by Erasmus+ to European Universities. (68) In order to increase the impact of the Programme in addressing Union priorities, synergies with programmes and instruments aiming to responding to emerging Union needs should be encouraged and sought, including with the Just Transition Mechanism, the Recovery and Resilience Facility and EU4Health Programme. (69) The rules for participation and dissemination should adequately reflect the needs of the Programme taking into account the concerns raised and the recommendations made by various stakeholders, as well as in the interim evaluation of Horizon 2020 carried out with the assistance of independent external experts. (70) Common rules across the Programme should ensure a coherent framework which facilitates participation in programmes financially supported by the budget of the Programme, including participation in programmes managed by funding bodies such as the EIT, joint undertakings or any other structures under Article 187 TFEU, and participation in programmes undertaken by Member States under Article 185 TFEU. Adopting specific rules should be possible, but such exceptions should be limited to when strictly necessary and duly justified. (71) Actions which fall within the scope of the Programme should respect fundamental rights and observe the principles acknowledged in particular by the Charter of Fundamental Rights of the European Union (the 'Charter'). Such actions should be in conformity with any legal obligation including international law and with any relevant Commission decisions such as the Commission notice of 28 June 2013 (24), as well as with ethical principles, which include avoiding any breach of research integrity. The opinions of the European Group on Ethics in Science and New Technologies, the European Union Agency for Fundamental Rights and the European Data Protection Supervisor should be taken into account, where appropriate. Article 13 TFEU should also be taken into account in research activities, and the use of animals in research and testing should be reduced, with a view ultimately to replacing their use. (72) In order to guarantee scientific excellence, and in line with Article 13 of the Charter, the Programme should promote the respect of academic freedom in all countries benefiting from its funds. (73) In accordance with the objectives of international cooperation as set out in Articles 180 and 186 TFEU, the participation of legal entities established in third countries and of international organisations should be promoted, based on mutual benefits and the Union's interests. The implementation of the Programme should be in conformity with the measures adopted in accordance with Articles 75 and 215 TFEU and should be in compliance with international law. For actions related to Union strategic assets, interests, autonomy or security, it should be possible for participation in specific actions of the Programme to be limited to legal entities established only in Member States or to legal entities established in specified associated or other third countries in addition to Member States. Any exclusion of legal entities established in the Union or in associated countries directly or indirectly controlled by non-associated third countries or by legal entities of non-associated third countries should take into account the risks the inclusion of such entities would represent, on the one hand, and the benefits that their participation would generate, on the other hand. (74) The Programme acknowledges climate change as one of the biggest global and societal challenges and reflects the importance of tackling climate change in accordance with the Union's commitment to implement the Paris Agreement and the SDGs. Accordingly, the Programme should contribute to mainstream climate actions and to the achievement of an overall target of 30 % of the Union budget expenditures supporting climate objectives. Climate mainstreaming should be adequately integrated in R&I content and applied at all stages of the research cycle. (75) In the context of the impact pathway related to climate, the Commission should report on the results, innovations and aggregated estimated effects of projects that are climate-relevant, including by Programme part and by implementation mode. In carrying out its analysis, the Commission should take account of the long-term economic, societal and environmental costs and benefits to Union citizens of activities under the Programme, including the uptake of innovative climate mitigation and adaptation solutions, the estimated impact on jobs and company creation, economic growth and competitiveness, clean energy, health and well-being, including air, soil and water quality. The results of that impact analysis should be made public, should be assessed in the context of the Union's climate and energy goals and should contribute to the subsequent strategic planning and future work programmes. (76) Reflecting the importance of tackling the dramatic loss of biodiversity, R&I activities under the Programme should contribute to the preservation and restoration of biodiversity and to the achievement of the overall ambition of providing 7,5 % of annual spending under the MFF to biodiversity objectives in 2024 and 10 % of annual spending under the MFF to biodiversity objectives in 2026 and 2027, while considering the existing overlaps between climate and biodiversity goals in accordance with the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources. (77) Horizontal financial rules adopted by the European Parliament and by the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the budget through grants, procurement, prizes and indirect implementation, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (78) It is possible that the use of sensitive background information or access by unauthorised individuals to sensitive results have an adverse impact on the interests of the Union or of one or more of the Member States. Thus handling of confidential data and classified information should be governed by all relevant Union law, including the Institutions' internal rules, such as Commission Decision (EU, Euratom) 2015/444 (25). (79) It is necessary to establish the minimum conditions for participation, both as a general rule where a consortium should include at least one legal entity from a Member State, and with regard to the specificities of particular types of action under the Programme. (80) It is necessary to establish the terms and conditions for providing Union funding to participants in actions under the Programme. Grants should be the main form of support in the Programme. They should be implemented taking into account all forms of contribution set out in the Financial Regulation, including lump sums, flat rates or unit costs, with a view to further simplification. The grant agreement should establish the rights and obligations of the beneficiaries, including the role and tasks of the coordinator where applicable. Close cooperation with Member States experts should be ensured in the drawing up of the model grant agreements and in any substantial amendment to them, in view, among other things, of further simplification for beneficiaries. (81) The funding rates in this Regulation are referred to as maximums in order to comply with the co-financing principle. (82) In accordance with the Financial Regulation, the Programme should provide the basis for a wider acceptance of the usual cost-accounting practices of the beneficiaries as regards personnel costs and unit costs for internally invoiced goods and services, including for large research infrastructures within the meaning of Horizon 2020. The use of unit costs for internally invoiced goods and services calculated in accordance with the usual accounting practices of the beneficiaries combining actual direct costs and indirect costs should be an option which could be chosen by all beneficiaries. In that respect, beneficiaries should be able to include actual indirect costs calculated on the basis of allocation keys in such unit costs for internally invoiced goods and services. (83) The current system of reimbursement of actual personnel costs should be further simplified, building on the project-based remuneration approach developed under Horizon 2020, and further aligned to the Financial Regulation, with the aim of reducing the remuneration gap between Union researchers involved in the Programme. (84) The Participant Guarantee Fund set up pursuant to Horizon 2020 and managed by the Commission has proved to be an important safeguard mechanism which mitigates the risks associated with the amounts due and not reimbursed by defaulting participants. Therefore, the Participant Guarantee Fund, renamed the mutual insurance mechanism (the 'Mechanism'), should be continued and enlarged to other funding bodies in particular to initiatives pursuant to Article 185 TFEU. It should be possible to extend the Mechanism to beneficiaries of any other directly managed Union programme. On the basis of close monitoring of the possible negative returns on the investments made by the Mechanism, the Commission should take appropriate mitigating measures in order to allow the Mechanism to continue its interventions for the protection of the financial interests of the Union and to return contributions to beneficiaries at the payment of the balance. (85) Rules governing the exploitation and dissemination of results should be laid down to ensure that beneficiaries protect, exploit, disseminate and provide access to those results as appropriate. More emphasis should be placed on to exploiting those results, and the Commission should identify and help maximise opportunities for beneficiaries to exploit results, in particular in the Union. The exploitation of results should take into consideration the principles of the Programme, including promoting innovation in the Union and strengthening the ERA. (86) The key elements of the proposal evaluation and selection system of Horizon 2020 with its particular focus on excellence and, where applicable, on 'impact' and 'quality and efficiency of implementation', should be maintained. Proposals should continue to be selected based on the evaluation made by independent external experts. The evaluation process should be designed to avoid conflicts of interest and bias. The possibility of a two-stage submission procedure should be taken into account and, where appropriate, anonymised proposals could be evaluated during the first stage of evaluation. The Commission should continue to involve independent observers in the evaluation process, where applicable. For Pathfinder activities, missions and in other duly justified cases as set out in the work programme, the necessity to ensure the overall coherence of the portfolio of projects may be taken into account, provided that the proposals have passed the applicable thresholds. The objectives and procedures for doing so should be published in advance. In accordance with Article 200(7) of the Financial Regulation, applicants should receive feedback on the evaluation of their proposal, including, in particular, where applicable, the reasons for rejection. (87) Systematic cross-reliance on assessments and audits with other Union programmes should be implemented in accordance with Articles 126 and 127 of the Financial Regulation for all parts of the Programme, where possible, in order to reduce administrative burden for beneficiaries of Union funds. Cross-reliance should be explicitly provided for by considering also other elements of assurance such as system and process audits. (88) Specific challenges in the areas of R&I should be addressed by prizes, including common or joint prizes where appropriate, organised by the Commission or the relevant funding body with other Union bodies, associated countries, other third countries, international organisations or non-profit legal entities. Prizes should support the achievement of the objectives of the Programme. (89) The types of financing and the methods of implementation under this Regulation should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden and the expected risk of non-compliance. This should include consideration of the use of lump sums, flat rates and scales of unit costs. (90) In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the MFF 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021. (91) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States, but can rather, by reason of avoiding duplication, reaching critical mass in key areas and maximising Union added value, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (92) Regulation (EU) No 1290/2013 of the European Parliament and of the Council (26) and Regulation (EU) No 1291/2013 should therefore be repealed, HAVE ADOPTED THIS REGULATION: TITLE I GENERAL PROVISIONS Article 1 Subject matter 1. This Regulation establishes Horizon Europe - the Framework Programme for Research and Innovation (the 'Programme') for the duration of the MFF 2021-2027, sets out the rules for participation and dissemination concerning indirect actions under the Programme and determines the framework governing Union support for R&I activities for the same duration. This Regulation lays down the objectives of the Programme, the budget for the period 2021 to 2027, the forms of Union funding and the rules for providing such funding. 2. The Programme shall be implemented through: (a) the specific programme established by Decision (EU) 2021/764; (b) a financial contribution to the European Institute of Innovation and Technology established by the EIT Regulation; (c) the specific programme on defence research established by Regulation (EU) 2021/697. 3. This Regulation does not apply to the specific programme on defence research referred to in point (c) of paragraph 2 of this Article, with the exception of Articles 1 and 5, Article 7(1) and Article 12(1). 4. The terms 'Horizon Europe', 'the Programme' and 'specific programme' used in this Regulation refer to matters relevant only to the specific programme referred to in point (a) of paragraph 2, unless otherwise specified. 5. The EIT shall implement the Programme in accordance with its strategic objectives for the period 2021 to 2027, as laid down in the Strategic Innovation Agenda of the EIT, taking into account the strategic planning referred to in Article 6 and in the specific programme referred to in point (a) of paragraph 2 of this Article. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) 'research infrastructures' means facilities that provide resources and services for the research communities to conduct research and foster innovation in their fields, including the associated human resources, major equipment or sets of instruments; knowledge-related facilities such as collections, archives or scientific data infrastructures; computing systems, communication networks and any other infrastructure of a unique nature and open to external users, essential to achieve excellence in R&I; they may, where relevant, be used beyond research, for example for education or public services and they may be 'single sited', 'virtual' or 'distributed'; (2) 'smart specialisation strategy' means the national or regional innovation strategies which set priorities in order to build competitive advantage by developing and matching R&I own strengths to business needs in order to address emerging opportunities and market developments in a coherent manner, while avoiding duplication and fragmentation of efforts, including those that take the form of, or are included in, a national or regional R&I strategic policy framework, and fulfilling the enabling condition set out in the relevant provisions of the Common Provisions Regulation for 2021-2027; (3) 'European Partnership' means an initiative, prepared with the early involvement of Member States and associated countries, where the Union together with private and/or public partners (such as industry, universities, research organisations, bodies with a public service mission at local, regional, national or international level or civil society organisations including foundations and NGOs) commit to jointly supporting the development and implementation of a programme of R&I activities, including those related to market, regulatory or policy uptake; (4) 'open access' means online access, provided free of charge to the end user, to research outputs resulting from actions under the Programme in accordance with Article 14 and Article 39(3); (5) 'open science' means an approach to the scientific process based on open cooperative work, tools and diffusing knowledge, and includes the elements listed in Article 14; (6) 'mission' means a portfolio of excellence-based and impact-driven R&I activities across disciplines and sectors, intended to: (i) achieve, within a set timeframe, a measurable goal that could not be achieved through individual actions; (ii) have an impact on society and policy-making through science and technology; and (iii) be relevant for a significant part of the European population and a wide range of European citizens; (7) 'pre-commercial procurement' means the procurement of research and development services involving risk-benefit sharing under market conditions, and competitive development in phases, where there is a clear separation of the research and development services procured from the deployment of commercial volumes of end-products; (8) 'public procurement of innovative solutions' means procurement where contracting authorities act as a launch customer for innovative goods or services which are not yet available on a large-scale commercial basis, and may include conformity testing; (9) 'access rights' means rights to use results or background under terms and conditions laid down in accordance with this Regulation; (10) 'background' means any data, know how or information whatever its form or nature, tangible or intangible, including any rights such as intellectual property rights, that is: (i) held by beneficiaries prior to their accession to a given action; and (ii) identified by the beneficiaries in a written agreement as needed for implementing the action or for exploiting its results; (11) 'dissemination' means the public disclosure of the results by appropriate means, other than resulting from protecting or exploiting the results, including by scientific publications in any medium; (12) 'exploitation' means the use of results in further R&I activities other than those covered by the action concerned, including among other things, commercial exploitation such as developing, creating, manufacturing and marketing a product or process, creating and providing a service, or in standardisation activities; (13) 'fair and reasonable conditions' means appropriate conditions, including possible financial terms or royalty-free conditions, taking into account the specific circumstances of the request for access, for example the actual or potential value of the results or background to which access is requested and/or the scope, duration or other characteristics of the exploitation envisaged; (14) 'funding body' means a body or organisation, as referred to in point (c) of Article 62(1) of the Financial Regulation, to which the Commission has entrusted budget implementation tasks under the Programme; (15) 'international European research organisation' means an international organisation, the majority of whose members are Member States or associated countries, whose principal objective is to promote scientific and technological cooperation in Europe; (16) 'legal entity' means a natural person, or a legal person created and recognised as such under Union, national or international law, which has legal personality and the capacity to act in its own name, exercise rights and be subject to obligations, or an entity which does not have legal personality as referred to in point (c) of Article 197(2) of the Financial Regulation; (17) 'widening countries' or 'low R&I performing countries' means countries where legal entities need to be established in order to be eligible as coordinators under the 'widening participation and spreading excellence' component of the 'Widening Participation and Strengthening ERA' part of the Programme; from the Member States, those countries are Bulgaria, Croatia, Cyprus, Czechia, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia, for the whole duration of the Programme; for associated countries, it means the list of eligible countries as defined based on an indicator and published in the work programme. Legal entities from outermost regions as defined in Article 349 TFUE shall be also fully eligible as coordinators under this component; (18) 'non-profit legal entity' means a legal entity which by its legal form is non-profit-making or which has a legal or statutory obligation not to distribute profits to its shareholders or individual members; (19) 'small or medium-sized enterprise' or 'SME' means a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Recommendation 2003/361/EC (27); (20) 'small mid-cap' means an entity that is not an SME and that has up to 499 employees where the staff headcount is calculated in accordance with Articles 3 to 6 of Annex to Recommendation 2003/361/EC; (21) 'results' means any tangible or intangible effect of a given action, such as data, knowhow or information, whatever its form or nature and whether or not it can be protected, as well as any rights attached to it, including intellectual property rights; (22) 'research output' means the results generated by a given action to which access can be given in the form of scientific publications, data or other engineered results and processes such as software, algorithms, protocols and electronic notebooks; (23) 'Seal of Excellence' means a quality label which shows that a proposal submitted to a call for proposals exceeded all of the evaluation thresholds set out in the work programme, but could not be funded due to lack of budget available for that call for proposals in the work programme and might receive support from other Union or national sources of funding; (24) 'strategic R&I plan' means an implementing act laying out a strategy for realising content in the work programme covering a maximum period of four years, follows a broad mandatory multi-stakeholder consultation process and specifies the priorities, suitable types of action and forms of implementation to be used; (25) 'work programme' means a document adopted by the Commission for the implementation of the specific programme in accordance with Article 14 of Decision (EU) 2021/764 or a document equivalent in content and structure adopted by a funding body; (26) 'contract' means an agreement concluded between the Commission or the relevant funding body with a legal entity implementing an innovation and market deployment action and supported by Horizon Europe blended finance or EIC blended finance; (27) 'reimbursable advance' means the part of the Horizon Europe blended finance or EIC blended finance that corresponds to a loan under Title X of the Financial Regulation, but that is directly awarded by the Union on a non-profit basis to cover the costs of activities corresponding to an innovation action, and which is to be reimbursed by the beneficiary to the Union under the conditions provided for in the contract; (28) 'classified information' means European Union classified information as defined in Article 3 of Decision (EU, Euratom) 2015/444 as well as classified information of Member States, classified information of third countries with which the Union has a security agreement and classified information of international organisation with which the Union has a security agreement; (29) 'blending operation' means an action supported by the Union budget, including within a blending facility or platform as defined in point (6) of Article 2 of the Financial Regulation, that combines non-repayable forms of support and/or financial instruments from the Union budget with repayable forms of support from development or other public finance institutions, as well as from commercial finance institutions and investors; (30) 'Horizon Europe blended finance' means financial support to a programme implementing innovation and market deployment action, consisting of a specific combination of a grant or reimbursable advance and an investment in equity or any other repayable form of support; (31) 'EIC blended finance' means direct financial support provided under the EIC to an innovation and market deployment action consisting of a specific combination of a grant or reimbursable advance and an investment in equity or any other repayable form of support; (32) 'research and innovation action' means an action primarily consisting of activities aiming to establish new knowledge or to explore the feasibility of a new or improved technology, product, process, service or solution. This may include basic and applied research, technology development and integration, testing, demonstration and validation on a small-scale prototype in a laboratory or simulated environment; (33) 'innovation action' means an action primarily consisting of activities directly aiming to produce plans and arrangements or designs for new, altered or improved products, processes or services, possibly including prototyping, testing, demonstrating, piloting, large-scale product validation and market replication; (34) 'ERC frontier research action' means a principal investigator-led research action, including ERC Proof of Concept, hosted by single or multiple beneficiaries receiving funding from the European Research Council (ERC); (35) 'training and mobility action' means an action geared towards the improvement of the skills, knowledge and career prospects of researchers, based on mobility between countries and, if relevant, between sectors or disciplines; (36) 'programme co-fund action' means an action to provide multi-annual co-funding to a programme of activities established or implemented by legal entities managing or funding R&I programmes, other than Union funding bodies; such a programme of activities may support networking and coordination, research, innovation, pilot actions, and innovation and market deployment actions, training and mobility actions, awareness raising and communication, dissemination and exploitation, and provide any relevant financial support, such as grants, prizes and procurement, as well as Horizon Europe blended finance or a combination thereof. The programme co-fund action may be implemented by those legal entities directly or by third parties on their behalf; (37) 'pre-commercial procurement action' means an action the primary aim of which is to realise the pre-commercial procurement implemented by beneficiaries that are contracting authorities or contracting entities; (38) 'public procurement of innovative solutions action' means an action the primary aim of which is to realise the joint or coordinated public procurement of innovative solutions implemented by beneficiaries that are contracting authorities or contracting entities; (39) 'coordination and support action' means an action contributing to the objectives of the Programme, excluding R&I activities, except when undertaken under the component 'widening participation and spreading excellence' of the part 'Widening participation and strengthening the ERA'; and bottom-up coordination without co-funding of research activities from the Union that allows for cooperation between legal entities from Member States and associated countries in order to strengthen the ERA; (40) 'inducement prize' means a prize to spur investment in a given direction by specifying a target prior to the performance of the work; (41) 'recognition prize' means a prize to reward past achievements and outstanding work after it has been performed; (42) 'innovation and market deployment action' means an action which embeds an innovation action and other activities necessary to deploy an innovation in the market, including the scaling-up of companies, Horizon Europe blended finance or EIC blended finance; (43) 'indirect actions' means R&I activities to which the Union provides financial support and which are undertaken by participants; (44) 'direct actions' means R&I activities undertaken by the Commission through its JRC; (45) 'procurement' means procurement as defined in point (49) of Article 2 of the Financial Regulation; (46) 'affiliated entity' means an entity as defined in Article 187(1) of the Financial Regulation; (47) 'innovation ecosystem' means an ecosystem that brings together at Union level actors or entities whose functional goal is to enable technology development and innovation; it encompasses relations between material resources (such as funds, equipment, and facilities), institutional entities (such as higher education institutions and support services, research and technology organisations, companies, venture capitalists and financial intermediaries) and national, regional and local policy-making and funding entities; (48) 'project-based remuneration' means remuneration that is linked to the participation of a person in projects, is part of the beneficiary's usual remuneration practices and is paid in a consistent manner. Article 3 Programme objectives 1. The general objective of the Programme is to deliver scientific, technological, economic and societal impact from the Union's investments in R&I so as to strengthen the scientific and technological bases of the Union and foster the competitiveness of the Union in all Member States including in its industry, to deliver on the Union strategic priorities and to contribute to the realisation of Union objectives and policies, to tackle global challenges, including the SDGs by following the principles of the 2030 Agenda and the Paris Agreement, and to strengthen the ERA. The Programme shall thus maximise Union added value by focusing on objectives and activities that cannot be effectively realised by Member States acting alone, but in cooperation. 2. The Programme has the following specific objectives: (a) to develop, promote and advance scientific excellence, to support the creation and diffusion of high-quality new fundamental and applied knowledge, of skills, technologies and solutions, to support training and mobility of researchers, to attract talent at all levels and contribute to the full engagement of the Union's talent pool in actions supported under the Programme; (b) to generate knowledge, strengthen the impact of R&I in developing, supporting and implementing Union policies and support the access to and uptake of innovative solutions in European industry, in particular SMEs, and in society to address global challenges, including climate change and the SDGs; (c) to foster all forms of innovation, facilitate technological development, demonstration and knowledge and technology transfer, strengthen deployment and exploitation of innovative solutions; (d) to optimise the Programme's delivery with a view to strengthening and increasing the impact and attractiveness of the ERA, to foster excellence-based participation from all Member States, including low R&I performing countries, in the Programme and to facilitate collaborative links in European R&I. Article 4 Programme structure 1. For the specific programme referred to in point (a) of Article 1(2) and the EIT, the Programme shall be structured in parts as follows, which contribute to the general and specific objectives set out in Article 3: (a) Pillar I 'Excellent Science', with the following components: (i) the ERC; (ii) Marie Skłodowska-Curie Actions (MSCA); (iii) research infrastructures; (b) Pillar II 'Global Challenges and European Industrial Competitiveness', with the following components, taking into account that SSH play an important role across all clusters: (i) cluster 'Health'; (ii) cluster 'Culture, Creativity and Inclusive Society'; (iii) cluster 'Civil Security for Society'; (iv) cluster 'Digital, Industry and Space'; (v) cluster 'Climate, Energy and Mobility'; (vi) cluster 'Food, Bioeconomy, Natural Resources, Agriculture and Environment'; (vii) non-nuclear direct actions of the JRC; (c) Pillar III 'Innovative Europe', with the following components: (i) the EIC; (ii) European innovation ecosystems; (iii) the EIT; (d) Part 'Widening Participation and Strengthening the ERA', with the following components: (i) widening participation and spreading excellence; (ii) reforming and enhancing the European R&I System. 2. The broad lines of activities of the Programme are set out in Annex I of this Regulation. Article 5 Defence research and development Activities to be carried out under the specific programme referred to in point (c) of Article 1(2) and which are laid down in Regulation (EU) 2021/697, shall have an exclusive focus on defence research and development, with objectives and broad lines of activities aiming to foster the competitiveness, efficiency and innovation capacity of the European defence technological and industrial base. Article 6 Strategic planning and implementation and forms of Union funding 1. The Programme shall be implemented by means of direct management or by means of indirect management by the funding bodies. 2. Funding under the Programme may be provided by means of indirect actions in any of the forms laid down in the Financial Regulation, however grants shall be the main form of support under the Programme. Funding under the Programme may also be provided through prizes, procurements and financial instruments within blending operations and equity support under the Accelerator. 3. The rules for participation and dissemination laid down in this Regulation shall apply to indirect actions. 4. The main types of action to be used under the Programme are defined in Article 2. The forms of funding referred to in paragraph 2 of this Article shall be used in a flexible manner across all objectives of the Programme with their use being determined on the basis of the needs and the characteristics of the particular objectives. 5. The Programme shall also support direct actions. Where those direct actions contribute to initiatives established under Article 185 or 187 TFEU, that contribution shall not be considered to be part of the financial contribution allocated to those initiatives. 6. The implementation of the specific programme referred to in point (a) of Article 1(2) and the EIT's KICs shall be supported by a transparent and strategic planning of R&I activities as laid down in the specific programme referred to in point (a) of Article 1(2), in particular for the pillar 'Global Challenges and European Industrial Competitiveness' and cover also relevant activities in other pillars and the 'Widening participation and strengthening the ERA' part. The Commission shall ensure the early involvement of Member States and extensive exchanges with the European Parliament, to be complemented by consultations with stakeholders and the general public. Strategic planning shall ensure alignment with other relevant Union programmes and consistency with Union priorities and commitments and increase complementarity and synergies with national and regional funding programmes and priorities, thereby strengthening the ERA. Areas for possible missions and areas for possible Institutionalised European Partnerships shall be established in Annex VI. 7. Where appropriate, in order to allow faster access to funds for small collaborative consortia, a fast track to research and innovation procedure (FTRI procedure) may be proposed under some of the calls for proposals dedicated to select research and innovation actions or innovation actions under the pillar 'Global Challenges and European Industrial Competitiveness' and the European Innovation Council Pathfinder. A call for proposals under the FTRI procedure shall have the following cumulative characteristics: (a) bottom-up calls for proposals; (b) a shorter time-to-grant, not exceeding six months; (c) a support provided only to small collaborative consortia composed of maximum six different and independent eligible legal entities; (d) a maximum financial support per consortium not exceeding EUR 2,5 million. The work programme shall identify the calls for proposals which use the FTRI procedure. 8. Activities of the Programme shall be delivered primarily through open, competitive calls for proposals, including within missions and European Partnerships. Article 7 Principles of the Programme 1. Research and innovation activities carried out under the specific programme referred to in point (a) of Article 1(2) and under the EIT shall have an exclusive focus on civil applications. Budgetary transfers between the amount allocated to the specific programme referred to in point (a) of Article 1(2) and the EIT and the amount allocated to the specific programme referred to in point (c) of Article 1(2) shall not be allowed and unnecessary duplication between the two programmes shall be avoided. 2. The Programme shall ensure a multidisciplinary approach and shall, where appropriate, provide for the integration of SSH across all clusters and activities developed under the Programme, including specific calls for proposals on SSH related topics. 3. The collaborative parts of the Programme shall ensure a balance between lower and higher TRLs, thereby covering the whole value chain. 4. The Programme shall ensure the effective promotion and integration of cooperation with third countries and international organisations and initiatives based on mutual benefits, the Union interests, international commitments and, where appropriate, reciprocity. 5. The Programme shall assist widening countries to increase their participation in it and to promote a broad geographical coverage in collaborative projects, including through spreading scientific excellence, boosting new collaborative links, stimulating brain circulation as well as through the implementation of Article 24(2) and Article 50(5). Those efforts shall be mirrored by proportional measures by Member States, including through setting attractive salaries for researchers, with the support of Union, national and regional funds. Without undermining the excellence criteria, particular attention shall be paid to geographical balance, subject to the situation in the field of R&I concerned, in evaluation panels and bodies such as boards and expert groups. 6. The Programme shall ensure the effective promotion of equal opportunities for all and the implementation of gender mainstreaming, including the integration of the gender dimension in R&I content. It shall aim to address the causes of gender imbalance. Particular attention shall be paid to ensuring, to the extent possible, gender balance in evaluation panels and in other relevant advisory bodies such as boards and expert groups. 7. The Programme shall be implemented in synergy with other Union programmes while aiming for maximal administrative simplification. A non-exhaustive list of synergies with other Union programmes is included in Annex IV. 8. The Programme shall contribute to increasing public and private investment in R&I in Member States, thereby helping to reach an overall investment of at least 3 % of Union GDP in research and development. 9. When implementing the Programme, the Commission shall continue to aim for administrative simplification and a reduction of the burden for the applicants and beneficiaries. 10. As part of the general Union objective of mainstreaming climate actions into Union sectoral policies and Union funds, actions under this Programme shall contribute at least 35 % of the expenditure to climate objectives where appropriate. Climate mainstreaming shall be adequately integrated in R&I content. 11. The Programme shall promote co-creation and co-design through the engagement of citizens and civil society. 12. The Programme shall ensure transparency and accountability of public funding in R&I projects, thereby preserving the public interest. 13. The Commission or the relevant funding body shall ensure that sufficient guidance and information is made available to all potential participants at the time of publication of the call for proposals, in particular the applicable model grant agreement. Article 8 Missions 1. Missions shall be programmed within the pillar 'Global Challenges and European Industrial Competitiveness', but may also benefit from actions carried out within other parts of the Programme as well as complementary actions carried out under other Union programmes. Missions shall allow for competing solutions, resulting in pan-European added value and impact. 2. Missions shall be defined and implemented in accordance with this Regulation and the specific programme, ensuring the active and early involvement of the Member States and extensive exchanges with the European Parliament. The missions, their objectives, budget, targets, scope, indicators and milestones shall be identified in strategic R&I plans or the work programmes as appropriate. Evaluations of proposals under the missions shall be carried out in accordance with Article 29. 3. During the first three years of the Programme, a maximum of 10 % of the annual budget of Pillar II shall be programmed through specific calls for proposals for implementing the missions. For the remaining years of the Programme that percentage may be increased subject to a positive assessment of the mission selection and of the management process. The Commission shall communicate the total budgetary share of each work programme dedicated to missions. 4. Missions shall: (a) using SDGs as sources for their design and implementation, have a clear R&I content and Union added value, and contribute to reaching Union priorities and commitments and the Programme objectives referred to in Article 3; (b) cover areas of common European relevance, be inclusive, encourage broad engagement and active participation from various types of stakeholders from the public and private sector, including citizens and end-users, and deliver R&I results that could benefit all Member States; (c) be bold and inspirational, hence have wide, scientific, technological, societal, economic, environmental or policy relevance and impact; (d) indicate a clear direction and clear objectives, be targeted, measurable and time-bound and have a clear budgetary envelope; (e) be selected in a transparent manner and be centred on ambitious, excellence-based and impact-driven, but realistic goals and on research, development and innovation activities; (f) have the necessary scope, scale and mobilisation of the resources and leverage of additional public and private funds required to deliver their outcome; (g) stimulate activities across disciplines (including SSH) and encompass activities from a broad range of TRLs, including lower TRLs; (h) be open to multiple, bottom-up approaches and solutions which take into account human and societal needs and benefits and recognise the importance of diverse contributions to their achievement; (i) benefit from synergies with other Union programmes in a transparent manner as well as with national and, where relevant, regional innovation ecosystems. 5. The Commission shall monitor and evaluate each mission in accordance with Articles 50 and 52 and Annex V, including progress towards short, medium and long-term targets, covering the implementation, monitoring and phasing-out of the missions. An assessment of the first missions established under the Programme shall take place no later than 2023 and before any decision is taken on creating new missions, or on continuing, terminating or redirecting ongoing missions. The results of that assessment shall be made public and shall include, but not be limited to, an analysis of their selection process and of their governance, budget, focus and progress to date. Article 9 The European Innovation Council 1. The Commission shall establish the EIC as a centrally managed one-stop shop for implementing actions under Pillar III 'Innovative Europe' which relate to the EIC. The EIC shall focus mainly on breakthrough and disruptive innovation, targeting especially market-creating innovation, while also supporting all types of innovation, including incremental. The EIC shall operate in accordance with the following principles: (a) clear Union added value; (b) autonomy; (c) ability to take risk; (d) efficiency; (e) effectiveness; (f) transparency; (g) accountability. 2. The EIC shall be open to all types of innovators including individuals, universities, research organisations and companies (SMEs, including start-ups, and, in exceptional cases, small mid-caps) as well as single beneficiaries and multi-disciplinary consortia. At least 70 % of EIC budget shall be dedicated to SMEs, including start-ups. 3. The EIC Board and the management features of the EIC are described in Decision (EU) 2021/764. Article 10 European Partnerships 1. Parts of the Programme may be implemented through European Partnerships. The involvement of the Union in European Partnerships shall take any of the following forms: (a) participation in European Partnerships set up on the basis of memoranda of understanding or contractual arrangements between the Commission and the partners referred to in point (3) of Article 2, specifying the objectives of the European Partnership, related commitments of the Union and of the other partners regarding their financial and/or in-kind contributions, key performance and impact indicators, the results to be delivered and reporting arrangements. They include the identification of complementary R&I activities that are implemented by the partners and by the Programme (Co-programmed European Partnerships); (b) participation in and financial contribution to a programme of R&I activities, specifying the objectives, key performance and impact indicators, and the results to be delivered, based on the commitment of the partners regarding their financial and/or in-kind contributions and the integration of their relevant activities using a Programme co-fund action (Co-funded European Partnerships); (c) participation in and financial contribution to R&I programmes undertaken by several Member States in accordance with Article 185 TFEU or by bodies established pursuant to Article 187 TFEU, such as Joint Undertakings or by the EIT's KICs in accordance with the EIT Regulation (Institutionalised European Partnerships). Institutionalised European Partnerships shall be implemented only where other parts of the Programme, including other forms of European Partnerships, would not achieve the objectives or would not generate the necessary expected impacts, and where justified by a long-term perspective and a high degree of integration. European Partnerships in accordance with Article 185 or Article 187 TFEU shall implement a central management of all financial contributions, except in duly justified cases. In the case of central management of all financial contributions, project level contributions from one participating state shall be made on the basis of the funding requested in proposals from legal entities established in that participating state, unless otherwise agreed among all participating states. The rules for Institutionalised European Partnerships shall specify, among other things, the objectives, key performance and impact indicators, and the results to be delivered, as well as the related commitments for financial and/or in-kind contributions of the partners. 2. European Partnerships shall: (a) be established for the purpose of addressing European or global challenges only in cases where the objectives of the Programme would be achieved more effectively through a European Partnership than by the Union alone and when compared to other forms of support under the Programme; an appropriate share of the budget of the Programme shall be allocated to those actions of the Programme that are implemented through European Partnerships; the majority of the budget in Pillar II shall be allocated to actions outside European Partnerships; (b) adhere to the principles of Union added value, transparency and openness, and to having impact within and for Europe, strong leverage effect on sufficient scale, long-term commitments of all involved parties, flexibility in implementation, coherence, coordination and complementarity with Union, local, regional, national and, where relevant, international initiatives or other European Partnerships and missions; (c) have a clear life-cycle approach, be limited in time and include conditions for phasing-out the Programme funding. 3. European Partnerships under points (a) and (b) of paragraph 1 of this Article shall be identified in strategic R&I plans before being implemented in work programmes. 4. Provisions and criteria for the selection, implementation, monitoring, evaluation and phasing-out of European Partnerships are set out in Annex III. Article 11 Review of missions and partnership areas By 31 December 2023, the Commission shall carry out a review of Annex VI to this Regulation as part of the overall monitoring of the Programme, including missions and Institutionalised European Partnerships established pursuant to Article 185 or 187 TFEU and present a report on the main findings to the European Parliament and to the Council. Article 12 Budget 1. The financial envelope for the implementation of the Programme for the period from 1 January 2021 to 31 December 2027 shall be EUR 86 123 000 000 in current prices for the specific programme referred to in point (a) of Article 1(2) and for the EIT and EUR 7 953 000 000 in current prices for the specific programme referred to in point (c) of Article 1(2). 2. The indicative distribution of the amount referred to in paragraph 1 for the specific programme referred to in point (a) of Article 1(2) and for the EIT shall be: (a) EUR 23 546 000 000 for Pillar I 'Excellent Science' for the period 2021 to 2027, of which: (i) EUR 15 027 000 000 for the ERC; (ii) EUR 6 333 000 000 for MSCA; (iii) EUR 2 186 000 000 for research infrastructures; (b) EUR 47 428 000 000 for Pillar II 'Global Challenges and European Industrial Competitiveness' for the period 2021 to 2027, of which: (i) EUR 6 893 000 000 for cluster 'Health'; (ii) EUR 1 386 000 000 for cluster 'Culture, Creativity and Inclusive Society'; (iii) EUR 1 303 000 000 for cluster 'Civil Security for Society'; (iv) EUR 13 462 000 000 for cluster 'Digital, Industry and Space'; (v) EUR 13 462 000 000 for cluster 'Climate, Energy and Mobility'; (vi) EUR 8 952 000 000 for cluster 'Food, Bioeconomy, Natural Resources, Agriculture and Environment'; (vii) EUR 1 970 000 000 for the non-nuclear direct actions of the JRC; (c) EUR 11 937 000 000 for Pillar III 'Innovative Europe' for the period 2021 to 2027, of which: (i) EUR 8 752 000 000 for the EIC; (ii) EUR 459 000 000 for European innovation ecosystems; (iii) EUR 2 726 000 000 for the EIT; (d) EUR 3 212 000 000 for Part 'Widening Participation and Strengthening the ERA' for the period 2021 to 2027, of which: (i) EUR 2 842 000 000 for 'widening participation and spreading excellence'; (ii) EUR 370 000 000 for 'reforming and enhancing the European R&I System'. 3. As a result of the Programme specific adjustment provided for in Article 5 of Regulation (EU, Euratom) 2020/2093 the amount referred to in the paragraph 1 for the specific programme referred to in point (a) of Article 1(2) of this Regulation and for the EIT shall be increased by an additional allocation of EUR 3 000 000 000 in constant 2018 prices as specified in Annex II to Regulation (EU, Euratom) 2020/2093. 4. The indicative distribution of the amount referred to in paragraph 3 shall be as follows: (a) EUR 1 286 000 000 in constant 2018 prices for Pillar I 'Excellent Science', of which: (i) EUR 857 000 000 in constant 2018 prices for the ERC; (ii) EUR 236 000 000 in constant 2018 prices for MSCA; (iii) EUR 193 000 000 in constant 2018 prices for research infrastructures; (b) EUR 1 286 000 000 in constant 2018 prices for Pillar II 'Global Challenges and European Industrial Competitiveness', of which: (i) EUR 686 000 000 in constant 2018 prices for cluster 'Culture, Creativity and Inclusive Society'; (ii) EUR 257 000 000 in constant 2018 prices for cluster 'Civil Security for Society'; (iii) EUR 171 000 000 in constant 2018 prices for cluster 'Digital, and Industry and Space'; (iv) EUR 171 000 000 in constant 2018 prices for cluster 'Climate, Energy and Mobility'; (c) EUR 270 000 000 in constant 2018 prices for Pillar III 'Innovative Europe', of which: (i) EUR 60 000 000 in constant 2018 prices for European innovation ecosystems; (ii) EUR 210 000 000 in constant 2018 prices for the EIT; (d) EUR 159 000 000 in constant 2018 prices for Part 'Widening Participation and Strengthening the ERA', of which: (i) EUR 99 000 000 in constant 2018 prices for 'widening participation and spreading sharing excellence'; (ii) EUR 60 000 000 in constant 2018 prices for 'reforming and enhancing the European R&I System'. 5. In order to respond to unforeseen situations or to new developments and needs, the Commission may, within the annual budgetary procedure, deviate from the amounts referred to in paragraph 2 up to a maximum of 10 %. There shall be no such deviation in respect of the amounts referred to in point (b)(vii) of paragraph 2 and the total amount set out for Part 'Widening Participation and Strengthening the ERA' of paragraph 2. 6. The amount referred to in paragraphs 1 and 3 of this Article for the specific programme referred to in point (a) of Article 1(2) and for the EIT, may also cover expenses for preparation, monitoring, control, audit, evaluation and other activities and expenditures necessary for managing and implementing the Programme, including all administrative expenditure, as well as evaluating the achievement of its objectives. The administrative expenses related to indirect actions shall not exceed 5 % of the total amount of indirect actions of the specific programme referred to in point (a) of Article 1(2) and of the EIT. Moreover, the amount referred to in paragraphs 1 and 3 of this Article for the specific programme referred to in point (a) of Article 1(2) and for the EIT may also cover: (a) in so far as they are related to the objectives of the Programme: expenses relating to studies, to meetings of experts, information and communication actions; (b) expenses linked to information technology networks focusing on information processing and exchange, including corporate information technology tools and other technical and administrative assistance needed in connection with the management of the Programme. 7. If necessary to enable the management of actions not completed by 31 December 2027, appropriations may be entered in the Union budget beyond 2027 to cover the expenses provided for in paragraph 6. 8. Budgetary commitments for actions extending over more than one financial year may be broken down into annual instalments over several years. 9. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation, in duly justified cases specified in the financing decision and for a limited period, activities supported under this Regulation and the underlying costs may be considered eligible as of 1 January 2021, even if they were implemented and incurred before the grant application was submitted. Article 13 Resources from the European Union Recovery Instrument 1. Subject to Article 3(3), (4), (7) and (9) of Regulation (EU) 2020/2094 the measures referred to in Article 1(2) of that Regulation shall be implemented under the Programme through amounts referred to in point (a)(iv) of Article 2(2) of that Regulation. 2. The amounts referred to in point (a)(iv) of Article 2(2) of Regulation (EU) 2020/2094 shall constitute external assigned revenue as set out in Article 3(1) of that Regulation. Those additional amounts shall exclusively be allocated to actions for R&I directed at addressing the consequences of the COVID-19 crisis, in particular its economic, social and societal consequences. Priority shall be given to innovative SMEs and special attention shall be paid to their integration in collaborative projects under Pillar II. 3. The indicative distribution of the amounts referred to in point (a)(iv) of Article 2(2) of Regulation (EU) 2020/2094 shall be: (a) 25 % to cluster 'Health'; (b) 25 % to cluster 'Digital, Industry and Space'; (c) 25 % to cluster 'Climate, Energy and Mobility'; (d) 25 % to the EIC. Article 14 Open science 1. The Programme shall encourage open science as an approach to the scientific process based on cooperative work and diffusing knowledge, in particular in accordance with the following elements which shall be ensured in accordance with Article 39(3) of this Regulation: (a) open access to scientific publications resulting from research funded under the Programme; (b) open access to research data, including those underlying scientific publications, in accordance with the principle 'as open as possible, as closed as necessary'. 2. The principle of reciprocity in open science shall be promoted and encouraged in all association and cooperation agreements with third countries, including agreements signed by funding bodies entrusted with the indirect management of the Programme. 3. Responsible management of research data shall be ensured in line with the principles 'findability', 'accessibility', 'interoperability' and 'reusability' (the 'FAIR principles'). Attention shall also be paid to the long-term preservation of data. 4. Other open science practices shall be promoted and encouraged, including for the benefit of SMEs. Article 15 Alternative, combined and cumulative funding and transfers of resources 1. The Programme shall be implemented in synergy with other Union programmes, in accordance with the principle set out in Article 7(7). 2. The Seal of Excellence shall be awarded for calls for proposals specified in the work programme. In accordance with the relevant provision of the Common Provisions Regulation for 2021-2027 and the relevant provision of the 'CAP Strategic Plan Regulation', the ERDF, the ESF+ or the EAFRD may support: (a) co-funded actions selected under the Programme; and (b) actions which were awarded a Seal of Excellence provided that they comply with all of the following conditions: (i) they have been assessed in a call for proposals under the Programme; (ii) they comply with the minimum quality requirements of that call for proposals; and (iii) they have not been financed under that call for proposals only due to budgetary constraints. 3. Financial contributions under programmes co-financed by the ERDF, the ESF+, the EMFAF and the EAFRD may be considered to be a contribution of the participating Member State to European Partnerships under points (b) and (c) of Article 10(1) of this Regulation, provided that the relevant provisions of the Common Provisions Regulation for 2021-2027 and the fund-specific regulations are complied with. 4. An action that has received a contribution from another Union programme may also receive a contribution under the Programme, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative financing shall not exceed the total eligible costs of the action. The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. 5. Resources allocated to Member States under shared management may, at the request of the Member State concerned, be transferred to the Programme subject to the conditions set out in the relevant provisions of the Common Provisions Regulation for 2021-2027. The Commission shall implement those resources directly in accordance with point (a) of the first subparagraph of Article 62(1) of the Financial Regulation or indirectly in accordance with point (c) of that subparagraph. Those resources shall be used for the benefit of the Member State concerned. 6. Where the Commission has not entered into a legal commitment under direct or indirect management for resources transferred in accordance with paragraph 5, the corresponding uncommitted resources may be transferred back to one or more respective source programmes, at the request of the Member State, in accordance with the conditions set out in the relevant provisions of the Common Provisions Regulation for 2021-2027. Article 16 Third countries associated to the Programme 1. The Programme shall be open to association of the following third countries (associated countries): (a) Members of the European Free Trade Association, which are members of the EEA, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) third countries and territories that fulfil all of the following criteria: (i) a good capacity in science, technology and innovation; (ii) commitment to a rules-based open market economy, including fair and equitable dealing with intellectual property rights, respect of human rights, backed by democratic institutions; (iii) active promotion of policies to improve the economic and social well-being of citizens. 2. Association to the Programme of each of the third countries under point (d) of paragraph 1 shall be in accordance with the conditions laid down in an agreement covering the participation of the third country to any Union programme, provided that the agreement: (a) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes; (b) lays down the conditions of participation in the Union programmes, including the calculation of financial contributions to individual programmes, and their administrative costs; (c) does not confer on the third country any decision-making power in respect of the Union programme; (d) guarantees the rights of the Union to ensure sound financial management and to protect the Union's financial interests. The contributions referred to in point (b) of the first subparagraph of this paragraph shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. 3. The scope of association of each third country to the Programme shall take into account an analysis of the benefits for the Union and the objective of driving economic growth in the Union through innovation. Accordingly, with the exception of EEA members, acceding countries, candidate countries and potential candidates, parts of the Programme may be excluded from an association agreement for a specific country. 4. The association agreement shall, as far as possible, provide for the reciprocal participation of legal entities established in the Union in equivalent programmes of associated countries in accordance with the conditions laid down in those programmes. 5. The conditions determining the level of financial contribution shall ensure a regular automatic correction of any significant imbalance compared to the amount that entities established in the associated country receive through participation in the Programme, taking into account the costs in the management, execution and operation of the Programme. The allocation of the financial contributions shall take into account the level of participation of the legal entities of the associated countries in each part of the Programme. TITLE II RULES FOR PARTICIPATION AND DISSEMINATION CHAPTER I General provisions Article 17 Funding bodies and direct actions of JRC 1. The rules set out in this Title do not apply to direct actions undertaken by the JRC. 2. In duly justified cases, funding bodies may depart from the rules set out in this Title, except for Articles 18, 19 and 20, if: (a) such a departure is provided for in the basic act setting up the funding body or entrusting budget implementation tasks to it; or (b) for funding bodies under points (ii), (iii) or (v) of point (c) of Article 62(1) of the Financial Regulation if it is provided for in the contribution agreement and if their specific operating needs or the nature of the action so require. Article 18 Eligible actions and ethical principles 1. Without prejudice to paragraph 2 of this Article, only actions implementing the objectives referred to in Article 3 shall be eligible for funding. The following fields of research shall not be financed: (a) activities aiming at human cloning for reproductive purposes; (b) activities intended to modify the genetic heritage of human beings which could make such modifications heritable (28); (c) activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer. 2. Research on human stem cells, both adult and embryonic, may be financed depending both on the contents of the scientific proposal and the legal framework of the Member States involved. No funding shall be provided within or outside the Union for research activities that are prohibited in all Member States. No funding shall be provided in a Member State for a research activity which is forbidden in that Member State. Article 19 Ethics 1. Actions carried out under the Programme shall comply with ethical principles and relevant Union, national and international law, including the Charter and the European Convention for the Protection of Human Rights and Fundamental Freedoms and its Supplementary Protocols. Particular attention shall be paid to the principle of proportionality, to the right to privacy, the right to the protection of personal data, the right to the physical and mental integrity of a person, the right to non-discrimination and to the need to ensure protection of the environment and high levels of human health protection. 2. Legal entities participating in an action shall provide: (a) an ethics self-assessment identifying and detailing all the foreseeable ethics issues related to the objective, implementation and likely impact of the activities to be funded, including a confirmation of compliance with paragraph 1 and a description of how it will be ensured; (b) a confirmation that the activities will comply with the European Code of Conduct for Research Integrity published by All European Academies and that no activities excluded from funding will be conducted; (c) for activities carried out outside the Union, a confirmation that the same activities would have been allowed in a Member State; and (d) for activities making use of human embryonic stem cells, as appropriate, details of licensing and control measures that shall be taken by the competent authorities of the Member States concerned as well as details of the ethics approvals that shall be obtained before the activities concerned start. 3. Proposals shall be systematically screened to identify actions which raise complex or serious ethics issues and submit them to an ethics assessment. The ethics assessment shall be carried out by the Commission unless it is delegated to the funding body. All actions involving the use of human embryonic stem cells or human embryos shall be subject to an ethics assessment. Ethics screenings and assessments shall be carried out with the support of ethics experts. The Commission and the funding bodies shall ensure the transparency of the ethics procedures without prejudice to the confidentiality of the content of those procedures. 4. Legal entities participating in an action shall obtain all approvals or other mandatory documents from the relevant national, local ethics committees or other bodies, such as data protection authorities, before the start of the relevant activities. Those documents shall be kept on file and provided to the Commission or the relevant funding body upon request. 5. If appropriate, ethics checks shall be carried out by the Commission or the relevant funding body. For serious or complex ethics issues, ethics checks shall be carried out by the Commission unless the Commission delegates this task to the funding body. Ethics checks shall be carried out with the support of ethics experts. 6. Actions which do not fulfil the ethics requirements referred to in paragraphs 1 to 4 and are therefore not ethically acceptable, shall be rejected or terminated once the ethical unacceptability has been established. Article 20 Security 1. Actions carried out under the Programme shall comply with the applicable security rules and in particular rules on the protection of classified information against unauthorised disclosure, including compliance with any relevant Union and national law. In the case of research carried out outside the Union using or generating classified information, it shall also be necessary that, in addition to the compliance with those requirements, a security agreement shall have been concluded between the Union and the third country in which the research is to be conducted. 2. Where appropriate, proposals shall include a security self-assessment identifying any security issues and detailing how those issues will be addressed in order to comply with the relevant Union and national law. 3. Where appropriate, the Commission or the relevant funding body shall carry out a security scrutiny procedure for proposals raising security issues. 4. Where appropriate, the actions carried out under the Programme shall comply with Decision (EU, Euratom) 2015/444 and its implementing rules. 5. Legal entities participating in an action shall ensure the protection against unauthorised disclosure of classified information used or generated by the action. They shall provide proof of personal security clearance or facility security clearance from the relevant national security authorities, prior to the start of the activities concerned. 6. If independent external experts have to deal with classified information, the appropriate security clearance shall be required before those experts are appointed. 7. Where appropriate, the Commission or the relevant funding body may carry out security checks. 8. Actions which do not comply with the security rules under this Article may be rejected or terminated at any time. CHAPTER II Grants Article 21 Grants Grants under the Programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation, unless otherwise specified in this Chapter. Article 22 Legal entities eligible for participation 1. Any legal entity, regardless of its place of establishment and including legal entities from non-associated third countries or international organisations, may participate in actions under the Programme, provided that the conditions laid down in this Regulation have been met together with any conditions laid down in the work programme or call for proposals. 2. Except in duly justified cases where the work programme otherwise provides, legal entities forming a consortium shall be eligible for participation in actions under the Programme provided that the consortium includes: (a) at least one independent legal entity established in a Member State; and (b) at least two other independent legal entities each established in different Member States or associated countries; 3. ERC frontier research actions, EIC actions, training and mobility actions or programme co-fund actions may be implemented by one or more legal entities, provided that one of those legal entities shall be established in a Member State or associated country on the basis of an agreement concluded in accordance with Article 16. 4. Coordination and support actions may be implemented by one or more legal entities, which may be established in a Member State, associated country or, in exceptional cases, in another third country. 5. For actions related to Union strategic assets, interests, autonomy or security, the work programme may provide that the participation can be limited to legal entities established only in Member States or to legal entities established in specified associated or other third countries in addition to Member States. Any limitation of the participation of legal entities established in associated countries which are EEA members shall be in accordance with the terms and conditions of the Agreement on the European Economic Area. For duly justified and exceptional reasons, in order to guarantee the protection of the strategic interests of the Union and its Member States, the work programme may also exclude the participation of legal entities established in the Union or in associated countries directly or indirectly controlled by non-associated third countries or by legal entities of non-associated third countries from individual calls for proposals, or make their participation subject to conditions set out in the work programme. 6. Where appropriate and duly justified, the work programme may provide for eligibility criteria in addition to those set out in paragraphs 2 to 5 to take into account specific policy requirements or the nature and objectives of the action, including the number of legal entities, the type of legal entity and the place of establishment. 7. For actions benefiting from amounts under Article 15(5), the participation shall be limited to a single legal entity established in the jurisdiction of the delegating managing authority, except if otherwise agreed with that managing authority. 8. Where indicated in the work programme, the JRC may participate in actions. 9. The JRC, international European research organisations and legal entities created under Union law shall be deemed to be established in a Member State other than the ones in which other legal entities participating in the action are established. 10. For ERC frontier research actions, training and mobility actions and when provided for in the work programme, international organisations with headquarters in a Member State or associated country shall be deemed to be established in that Member State or associated country. For other parts of the Programme, international organisations other than international European research organisations shall be deemed to be established in a non-associated third country. Article 23 Legal entities eligible for funding 1. Legal entities shall be eligible for funding if they are established in a Member State or an associated country. Only legal entities established in the jurisdiction of the delegating managing authority shall be eligible for funding for actions benefiting from amounts under Article 15(5), except if otherwise agreed by that managing authority. 2. Legal entities established in a non-associated third country shall bear the cost of their participation. However, a legal entity established in low to middle income non-associated third countries and, exceptionally, other non-associated third countries, shall be eligible for funding in an action if: (a) the third country is identified in the work programme adopted by the Commission; or (b) the Commission or the relevant funding body considers that the participation of the legal entity concerned is essential for implementing the action. 3. Affiliated entities are eligible for funding in an action if they are established in a Member State, an associated country or in a third country identified in the work programme adopted by the Commission. 4. The Commission shall make available on a regular basis to the European Parliament and to the Council information concerning the amount of the Union's financial contributions provided to legal entities established in associated and non-associated third countries. As regards associated countries, that information shall also include information on their financial balance. Article 24 Calls for proposals 1. The content of the calls for proposals for all actions shall be included in the work programme. 2. If necessary to achieve their objectives, calls for proposals may, in exceptional cases, be restricted in order to develop additional activities or to add additional partners to existing actions. In addition, the work programme may provide for the possibility for legal entities from low R&I performing countries to join already selected collaborative R&I actions, subject to the agreement of the respective consortium and provided that legal entities from such countries are not yet participating in it. 3. A call for proposals is not required for coordination and support actions or programme co-fund actions which: (a) are to be carried out by the JRC or legal entities identified in the work programme; (b) do not fall within the scope of a call for proposals, in accordance with point (e) of Article 195 of the Financial Regulation. 4. The work programme shall specify calls for proposals for which Seals of Excellence may be awarded. With prior authorisation from the applicant, information concerning the application and the evaluation may be shared with interested financing authorities, subject to the conclusion of confidentiality agreements. Article 25 Joint calls for proposals The Commission or the relevant funding body may issue a joint call for proposals with: (a) third countries, including their scientific and technological organisations or agencies; (b) international organisations; (c) non-profit legal entities. In the case of a joint call for proposals, the applicants shall fulfil the requirements under Article 22 and joint procedures shall be established for the selection and evaluation of proposals. Such procedures shall involve a balanced group of experts appointed by each party. Article 26 Pre-commercial procurement and public procurement of innovative solutions 1. Actions may involve or have as their primary aim the pre-commercial procurement or public procurement of innovative solutions that shall be carried out by beneficiaries which are contracting authorities or contracting entities as defined in Directives 2014/24/EU (29) and 2014/25/EU (30) of the European Parliament and of the Council. 2. The procurement procedures: (a) shall comply with competition rules and with the principles of transparency, non-discrimination, equal treatment, sound financial management, proportionality; (b) may authorise the award of multiple contracts within the same procedure (multiple sourcing); (c) shall provide for the award of the contracts to the tenders offering best value for money while ensuring absence of conflicts of interest. In the case of pre-commercial procurement, where appropriate and without prejudice to the principles enumerated in point (a), the procurement procedure may be simplified or accelerated and may provide for specific conditions such as limiting the place of performance of the procured activities to the territory of the Member States and of the associated countries. 3. The contractor generating results in pre-commercial procurement shall own at least the intellectual property rights attached to those results. The contracting authorities shall enjoy at least royalty-free access rights to the results for their own use and the right to grant, or require the participating contractors to grant, non-exclusive licences to third parties to exploit the results for the contracting authority under fair and reasonable conditions without any right to sub-license. If a contractor fails to commercially exploit the results within a given period after the pre-commercial procurement as identified in the contract, the contracting authorities, after having consulted the contractor on the reasons for the non-exploitation, may require it to transfer any ownership of the results to the contracting authorities. Article 27 Financial capacity of applicants 1. In addition to the exceptions mentioned in Article 198(5) of the Financial Regulation, the financial capacity shall be verified only for the coordinator and only if the requested funding from the Union for the action is equal to or greater than EUR 500 000. 2. Notwithstanding paragraph 1, if there are grounds to doubt the financial capacity of an applicant, or if there is a higher risk due to the participation in several ongoing actions funded by Union R&I programmes, the Commission or the relevant funding body shall also verify the financial capacity of other applicants, or of coordinators even where the requested funding is below the threshold referred to in paragraph 1. 3. If the financial capacity is structurally guaranteed by another legal entity, the financial capacity of that other legal entity shall be verified. 4. In the case where the financial capacity of an applicant is weak, the Commission or the relevant funding body may make participation of the applicant conditional on provision of a declaration on joint and several liability by an affiliated entity. 5. The contribution to the Mechanism set out in Article 37 of this Regulation shall be considered to be a sufficient guarantee under Article 152 of the Financial Regulation. No additional guarantee or security shall be accepted from beneficiaries or imposed upon them. Article 28 Award criteria and selection 1. A proposal shall be evaluated on the basis of the following award criteria: (a) excellence; (b) impact; (c) quality and efficiency of the implementation. 2. Only the criterion referred to in point (a) of paragraph 1 shall apply to proposals for ERC frontier research actions. 3. The work programme shall lay down further details concerning the application of the award criteria laid down in paragraph 1 including any weighting, thresholds and where relevant rules for dealing with ex aequo proposals, taking into consideration the objectives of the call for proposals. The conditions for dealing with ex aequo proposals may include, but shall not be limited to, the following criteria: SMEs, gender, and geographical diversity. 4. The Commission and other funding bodies shall take into account the possibility of a two-stage submission and evaluation procedure and where appropriate, anonymised proposals may be evaluated during the first stage of evaluation based on one or more of the award criteria referred to in paragraph 1. Article 29 Evaluation 1. Proposals shall be evaluated by the evaluation committee which shall be composed of independent external experts. For EIC activities, missions and in duly justified cases as set out in the work programme adopted by the Commission, the evaluation committee may be composed partially or, in the case of coordination and support actions, partially or fully of representatives of Union institutions or bodies as referred to in Article 150 of the Financial Regulation. The evaluation process may be followed by independent observers. 2. Where applicable, the evaluation committee shall rank the proposals that have passed the applicable thresholds, according to: (a) the evaluation scores; (b) their contribution to the achievement of specific policy objectives, including the constitution of a consistent portfolio of projects namely for Pathfinder activities, missions and in other duly justified cases as set out in the work programme adopted by the Commission in detail. For EIC activities, missions and in other duly justified cases as set out in the work programme adopted by the Commission in detail, the evaluation committee may also propose adjustments to the proposals insofar as those adjustments are needed for the consistency of the portfolio approach. Those adjustments shall be in conformity with the conditions for participation and comply with the principle of equal treatment. The Programme Committee shall be informed of such cases. 3. The evaluation process shall be designed to avoid conflicts of interest and bias. The transparency of the evaluation criteria and of the proposal scoring method shall be guaranteed. 4. In accordance with Article 200(7) of the Financial Regulation, applicants shall receive feedback at all stages of the evaluation and, where the proposal is rejected, the reasons for rejection. 5. Legal entities established in low R&I performing countries who have participated successfully in the component 'widening participation and spreading excellence' shall receive, upon request, a record of their participation, that may accompany proposals to the collaborative parts of the Programme that they coordinate. Article 30 Evaluation review procedure, enquiries and complaints 1. An applicant may request an evaluation review if it considers that the applicable evaluation procedure has not been correctly applied to its proposal (31). 2. Only the procedural aspects of an evaluation may be the subject of a request for an evaluation review. The evaluation of the merits of a proposal shall not be the subject of an evaluation review. 3. A request for an evaluation review shall relate to a specific proposal and shall be submitted within 30 days after the communication of evaluation results. An evaluation review committee shall provide an opinion on the procedural aspects of the evaluation, and shall be chaired by and include staff of the Commission or of the relevant funding body who were not involved in the evaluation of the proposals. The evaluation review committee may recommend one of the following: (a) a re-evaluation of the proposal to be carried out primarily by evaluators who were not involved in the previous evaluation; or (b) confirmation of the initial evaluation. 4. An evaluation review shall not delay the selection process for proposals that are not the subject of that review. 5. The Commission shall ensure the existence of a procedure for participants to make direct enquiries and complaints about their involvement in the Programme. Information on how to register enquiries or complaints shall be made available online. Article 31 Time-to-grant 1. By way of derogation from the first subparagraph of Article 194(2) of the Financial Regulation, the following periods shall apply: (a) for informing all applicants of the outcome of the evaluation of their application, a maximum period of five months from the final date for submission of complete proposals; (b) for signing grant agreements with applicants, a maximum period of eight months from the final date for submission of complete proposals. 2. The work programme may establish shorter periods than those provided for in paragraph 1. 3. In addition to the exceptions laid down in the second subparagraph of Article 194(2) of the Financial Regulation, the periods referred to in paragraph 1 of this Article may be exceeded for actions of the ERC, for missions and when actions are submitted to an ethics assessment or security scrutiny. Article 32 Implementation of the grant 1. If a beneficiary fails to comply with its obligations regarding the technical implementation of the action, the other beneficiaries shall comply with those obligations without any additional Union funding, unless they are expressly relieved of that obligation. The financial responsibility of each beneficiary shall be limited to its own debt subject to the provisions relating to the Mechanism. 2. The grant agreement may establish milestones and related pre-financing instalments. If milestones are not reached, the action may be suspended, amended, or, where duly justified, terminated. 3. An action may also be terminated where expected results have lost their relevance for the Union for scientific or technological reasons or, in the case of the Accelerator, also for economic reasons or, in the case of EIC and missions, also due to their relevance as part of a portfolio of actions. The Commission shall undergo a procedure with the action coordinator and, if appropriate, with independent external experts, before deciding to terminate an action, in accordance with Article 133 of the Financial Regulation. Article 33 Grant agreements 1. The Commission shall, in close cooperation with Member States, draw up model grant agreements between the Commission or the relevant funding body and the beneficiaries in accordance with this Regulation. If a significant modification of a model grant agreement is required, in view, among other things, of further simplification for beneficiaries, the Commission shall, in close cooperation with Member States, revise that model grant agreement as appropriate. 2. Grant agreements shall establish the rights and obligations of the beneficiaries and of either the Commission or the relevant funding body in compliance with this Regulation. They shall also establish the rights and obligations of legal entities which become beneficiaries during the implementation of the action, as well as the role and tasks of a coordinator. Article 34 Funding rates 1. A single funding rate per action shall apply for all activities it funds. The maximum rate per action shall be fixed in the work programme. 2. Up to 100 % of total eligible costs of an action under the Programme may be reimbursed, except for: (a) innovation actions where, up to 70 % of the total eligible costs may be reimbursed, except for non-profit legal entities where up to 100 % of the total eligible costs may be reimbursed; (b) programme co-fund actions where, at least 30 % and, in identified and duly justified cases, up to 70 % of the total eligible costs may be reimbursed. 3. The funding rates determined in this Article shall also apply for actions where flat-rate, unit or lump-sum financing is fixed for the whole action or part thereof. Article 35 Indirect costs 1. Indirect eligible costs shall be 25 % of the total direct eligible costs, excluding direct eligible costs for subcontracting, financial support to third parties and any unit costs or lump sums which include indirect costs. Where appropriate, indirect costs included in unit costs or lump sums shall be calculated using the flat rate referred to in the first subparagraph, except for unit costs for internally invoiced goods and services, which shall be calculated on the basis of actual costs, in accordance with the beneficiaries' usual cost accounting practice. 2. Notwithstanding paragraph 1, if provided for in the work programme, indirect costs may be declared in the form of a lump sum or unit costs. Article 36 Eligible costs 1. In addition to the criteria set out in Article 186 of the Financial Regulation, for beneficiaries with project-based remuneration, personnel costs are eligible up to the remuneration that the person would be paid for work in R&I projects funded by national schemes including social security charges and other costs linked to the remuneration of personnel assigned to the action, arising from national law or from the employment contract. 2. By way of derogation from Article 190(1) of the Financial Regulation, costs of resources made available by third parties by means of in-kind contributions shall be eligible up to the direct eligible costs of the third party. 3. By way of derogation from Article 192 of the Financial Regulation, income generated by the exploitation of the results shall not be considered to be receipts of the action. 4. Beneficiaries may use their usual accounting practices to identify and declare the costs incurred in relation to an action in compliance with all terms and conditions set out in the grant agreement, in accordance with this Regulation and Article 186 of the Financial Regulation. 5. By way of derogation from Article 203(4) of the Financial Regulation, a certificate on the financial statements shall be mandatory at payment of the balance, if the amount claimed as actual costs and unit costs calculated in accordance with usual cost accounting practices is equal to or greater than EUR 325 000. Certificates on financial statements may be produced by an approved external auditor or, in the case of public bodies, issued by a competent and independent public officer in accordance with Article 203(4) of the Financial Regulation. 6. Where appropriate, for MSCA training and mobility actions, the Union contribution shall take due account of any additional costs of the beneficiary related to maternity leave, parental leave, sick leave, special leave or to a change of recruiting host organisation or a change in the family status of researcher during the duration of the grant agreement. 7. Costs related to open access including data management plans shall be eligible for reimbursement as further stipulated in the grant agreement. Article 37 Mutual insurance mechanism 1. A mutual insurance mechanism (the 'Mechanism') is hereby established which shall replace and succeed the fund set up in accordance with Article 38 of Regulation (EU) No 1290/2013. The Mechanism shall cover the risk associated with non-recovery of sums due by the beneficiaries: (a) to the Commission under Decision No 1982/2006/EC of the European Parliament and of the Council (32); (b) to the Commission and Union bodies under 'Horizon 2020'; (c) to the Commission and funding bodies under the Programme. The coverage of the risk regarding the funding bodies referred to in point (c) of the first subparagraph may be implemented through an indirect coverage system set out in the applicable agreement and taking into account the nature of the funding body. 2. The Mechanism shall be managed by the Union, represented by the Commission acting as executive agent. The Commission shall set up specific rules for the operation of the Mechanism. 3. Beneficiaries shall make a contribution of 5 % of the Union funding for the action. On the basis of periodic transparent evaluations, the Commission may increase that contribution up to 8 % or reduce it to under 5 %. The contribution of the beneficiaries to the Mechanism shall be offset against the initial pre-financing and paid to the Mechanism on behalf of the beneficiaries. That contribution shall not exceed the amount of the initial pre-financing. 4. The contribution of the beneficiaries shall be returned at the payment of the balance. 5. Any financial return generated by the Mechanism shall be added to the Mechanism. If the return is insufficient the Mechanism shall not intervene, and the Commission or the relevant funding body shall recover any amount owed directly from the beneficiaries or third parties. 6. The amounts recovered shall constitute revenue assigned to the Mechanism within the meaning of Article 21(5) of the Financial Regulation. Once all grants for which the risk is covered directly or indirectly by the Mechanism are completed, any sums outstanding shall be recovered by the Commission and entered into the budget of the Union, subject to decisions of the legislative authority. 7. The Mechanism may be extended to beneficiaries of any other directly managed Union programme. The Commission shall adopt conditions for participation of beneficiaries of other programmes. Article 38 Ownership and protection 1. Beneficiaries shall own the results they generate. They shall ensure that any rights of their employees or any other parties in relation to the results can be exercised in a manner compatible with the beneficiaries' obligations in the grant agreement. Two or more beneficiaries shall own results jointly where: (a) they have jointly generated them; and (b) it is not possible to: (i) establish the respective contribution of each beneficiary; or (ii) separate them when applying for, obtaining or maintaining their protection. The joint owners shall agree in writing on the allocation and terms of exercise of their joint ownership. Unless otherwise agreed in the consortium agreement or in the joint ownership agreement, each joint owner may grant non-exclusive licences to third parties to exploit the jointly-owned results (without any right to sub-license), if the other joint owners are given advance notice and fair and reasonable compensation. The joint owners may agree in writing to apply another regime than joint ownership. 2. Beneficiaries which have received Union funding shall adequately protect their results if protection is possible and justified, taking into account all relevant considerations, including the prospects for commercial exploitation and any other legitimate interests. When deciding on protection, beneficiaries shall also consider the legitimate interests of the other beneficiaries in the action. Article 39 Exploitation and dissemination 1. Each beneficiary that has received Union funding shall use its best efforts to exploit the results it owns, or to have them exploited by another legal entity. Exploitation may be direct by the beneficiaries or indirect in particular through the transfer and licensing of results in accordance with Article 40. The work programme may provide for additional exploitation obligations. If, despite a beneficiary's best efforts to exploit its results directly or indirectly, the results are not exploited within a given period as established in the grant agreement, the beneficiary shall use an appropriate online platform as identified in the grant agreement to find interested parties to exploit those results. That obligation may be waived at the request of the beneficiary if justified. 2. Beneficiaries shall disseminate their results as soon as feasible, in a publicly available format, subject to any restrictions due to the protection of intellectual property, security rules or legitimate interests. The work programme may provide for additional dissemination obligations while safeguarding the Union's economic and scientific interests. 3. Beneficiaries shall ensure that open access to scientific publications applies under the terms and conditions laid down in the grant agreement. In particular, the beneficiaries shall ensure that they or the authors retain sufficient intellectual property rights to comply with their open access requirements. Open access to research data shall be the general rule under the terms and conditions laid down in the grant agreement, ensuring the possibility of exceptions following the principle 'as open as possible, as closed as necessary', taking into consideration the legitimate interests of the beneficiaries including commercial exploitation and any other constraints, such as data protection rules, privacy, confidentiality, trade secrets, Union competitive interests, security rules or intellectual property rights. The work programme may provide for additional incentives or obligations for the purpose of adhering to open science practices. 4. Beneficiaries shall manage all research data generated in an action under the Programme in line with the FAIR principles and in accordance with the grant agreement and shall establish a Data Management Plan. The work programme may provide, where justified, for additional obligations to use the EOSC for storing and giving access to research data. 5. Beneficiaries that intend to disseminate their results shall give advance notice to the other beneficiaries in the action. Any other beneficiary may object if it can show that dissemination of the results would significantly harm its legitimate interests in relation to its results or background. In such cases, the results shall not be disseminated unless appropriate steps are taken to safeguard those legitimate interests. 6. Unless the work programme provides otherwise, proposals shall include a plan for the exploitation and dissemination of the results. If the expected exploitation of the results entails developing, creating, manufacturing and marketing a product or process, or in creating and providing a service, the plan shall include a strategy for such exploitation. If the plan provides for the exploitation of the results primarily in non-associated third countries, the legal entities shall explain how that exploitation is still to be considered to be in the Union interest. The beneficiaries shall update the plan for the exploitation and dissemination of the results during and after the end of the action, in accordance with the grant agreement. 7. For the purposes of monitoring and dissemination by the Commission or the relevant funding body, the beneficiaries shall provide any information requested regarding the exploitation and dissemination of their results, in accordance with the grant agreement. Subject to the legitimate interests of the beneficiaries, such information shall be made publicly available. Article 40 Transfer and licensing 1. Beneficiaries may transfer ownership of their results. They shall ensure that their obligations also apply to the new owner and that the latter has the obligation to pass them on in any subsequent transfer. 2. Unless otherwise agreed in writing for specifically identified third parties including affiliated entities or unless impossible under applicable law, beneficiaries that intend to transfer ownership of results shall give advance notice to any other beneficiary that still has access rights to the results. The notification shall include sufficient information on the new owner to enable a beneficiary to assess the effects on its access rights. Unless otherwise agreed in writing for specifically identified third parties including affiliated entities, a beneficiary may object to the transfer of ownership of results by another beneficiary if it can show that the transfer would adversely affect its access rights. In this case, the transfer shall not take place until agreement has been reached between the beneficiaries concerned. The grant agreement shall lay down time limits in this respect. 3. Beneficiaries may grant licences to their results or otherwise give the right to exploit them, including on an exclusive basis, if this does not affect compliance with their obligations. Exclusive licences for results may be granted subject to consent by all the other beneficiaries concerned that they will waive their access rights thereto. 4. Where justified, the grant agreement shall provide for the right for the Commission or the relevant funding body to object to transfers of ownership of results, or to grants of an exclusive licence regarding results, if: (a) the beneficiaries which generated the results have received Union funding; (b) the transfer or licensing is to a legal entity established in a non-associated third country; and (c) the transfer or licensing is not in line with Union interests. If the right to object is provided for, the beneficiary shall give advance notice of its intention to transfer ownership of results or to grant an exclusive licence regarding results. The right to object may be waived in writing regarding transfers or grants to specifically identified legal entities if measures safeguarding Union interests are in place. Article 41 Access rights 1. Requests to exercise access rights and the waiver of access rights shall be in writing. 2. Unless otherwise agreed with the grantor, access rights shall not include the right to sub-license. 3. Before acceding to the grant agreement the beneficiaries shall inform each other of any restrictions to granting access to their background. 4. If a beneficiary is no longer involved in an action, this shall not affect its obligations to grant access. 5. If a beneficiary defaults on its obligations, the beneficiaries may agree that that beneficiary no longer has access rights. 6. Beneficiaries shall grant access to: (a) their results on a royalty-free basis to any other beneficiary in the action that needs them to implement its own tasks; (b) their background to any other beneficiary in the action that needs it to implement its own tasks, subject to any restrictions referred to in paragraph 3; that access shall be granted on a royalty-free basis, unless otherwise agreed by the beneficiaries before their accession to the grant agreement; (c) their results and, subject to any restrictions referred to in paragraph 3, to their background to any other beneficiary in the action that needs them to exploit its own results; that access shall be granted under fair and reasonable conditions to be agreed upon. 7. Unless otherwise agreed by the beneficiaries, they shall also grant access to their results and, subject to any restrictions referred to in paragraph 3, to their background to a legal entity that: (a) is established in a Member State or associated country; (b) is under the direct or indirect control of another beneficiary, or is under the same direct or indirect control as that beneficiary, or is directly or indirectly controlling that beneficiary; and (c) needs the access to exploit the results of that beneficiary, in accordance with the beneficiary's exploitation obligations. Access shall be granted under fair and reasonable conditions to be agreed upon. 8. A request for access for exploitation purposes may be made up to one year after the end of the action, unless the beneficiaries agree on a different time limit. 9. Beneficiaries that have received Union funding shall grant access to their results on a royalty-free basis to the Union institutions, bodies, offices or agencies for developing, implementing and monitoring Union policies or programmes. Access shall be limited to non-commercial and non-competitive use. Such access rights shall not extend to the beneficiaries' background. In actions under the cluster 'Civil Security for Society', beneficiaries that have received Union funding shall also grant access to their results on a royalty-free basis to Member States' national authorities, for developing, implementing and monitoring their policies or programmes in that area. Access shall be limited to non-commercial and non-competitive use and shall be subject to a bilateral agreement defining specific conditions aimed at ensuring that those access rights are used only for the intended purpose and that appropriate confidentiality obligations are in place. The requesting Member State, Union institution, body, office or agency shall notify all Member States of such requests. 10. The work programme may provide, where appropriate, for additional access rights. Article 42 Specific provisions 1. Specific provisions on ownership, exploitation and dissemination, transfer and licensing as well as access rights may apply for ERC actions, training and mobility actions, pre-commercial procurement actions, public procurement of innovative solutions actions, programme co-fund actions and coordination and support actions. 2. The specific provisions referred to in paragraph 1 shall be set out in the grant agreement and shall not change the principles and obligations on open access. Article 43 Prizes 1. Unless otherwise specified in this Chapter, inducement or recognition prizes under the Programme shall be awarded and managed in accordance with Title IX of the Financial Regulation. 2. Unless otherwise provided in the work programme or the contest rules, any legal entity, regardless of its place of establishment, may participate in a contest. 3. The Commission or the relevant funding body may, where appropriate, organise prize contests with: (a) other Union bodies; (b) third countries, including their scientific and technological organisations or agencies; (c) international organisations; or (d) non-profit legal entities. 4. Work programmes or contest rules shall include obligations regarding communication and, where appropriate, exploitation and dissemination, ownership and access rights including licensing provisions. CHAPTER III Procurement Article 44 Procurement 1. Unless otherwise specified in this Chapter, procurement under the Programme shall be carried out in accordance with Title VII of the Financial Regulation. 2. Procurement may also take the form of pre-commercial procurement or public procurement of innovative solutions carried out by the Commission or the relevant funding body on its own behalf or jointly with contracting authorities from Member States and associated countries. In such cases, the rules set out in Article 26 shall apply. CHAPTER IV Blending operations and blended finance Article 45 Blending operations Blending operations under the Programme shall be implemented in accordance with the InvestEU Programme and Title X of the Financial Regulation. Article 46 Horizon Europe blended finance and EIC blended finance 1. The grant and reimbursable advance components of Horizon Europe blended finance and EIC blended finance shall be subject to Articles 34 to 37. 2. EIC blended finance shall be implemented in accordance with Article 48 of this Regulation. Support under EIC blended finance may be granted until the action can be financed as a blending operation or as a financing and investment operation fully covered by the Union guarantee under the InvestEU Programme. By way of derogation from Article 209 of the Financial Regulation, the conditions laid down in paragraph 2 of that Article and, in particular points (a) and (d) thereof, do not apply at the time of the award of EIC blended finance. 3. Horizon Europe blended finance may be awarded to a programme co-fund action where a joint programme of Member States and associated countries provides for the deployment of financial instruments in support of selected actions. The evaluation and selection of such actions shall be made in accordance with Articles 15, 23, 24, 27, 28 and 29. The conditions for implementation of Horizon Europe blended finance shall comply with Article 32, by analogy with Article 48(10) and with any additional and justified conditions set out in the work programme. 4. Repayments including reimbursed advances and revenues of Horizon Europe blended finance and EIC blended finance shall be considered to be internal assigned revenues in accordance with point (f) of Article 21(3) and Article 21(4) of the Financial Regulation. 5. Horizon Europe blended finance and EIC blended finance shall be provided in a manner that promotes the Union's competitiveness while not distorting competition in the internal market. Article 47 The Pathfinder 1. The Pathfinder shall provide grants to high-risk cutting-edge projects, implemented by consortia or single beneficiaries, aiming to develop radical innovations and new market opportunities. The Pathfinder shall provide support for the earliest stages of scientific, technological or deep-tech research and development, including proof of concept and prototypes for technology validation. The Pathfinder shall be implemented mainly through an open call for proposals for bottom-up proposals with regular cut-off dates per year and shall also provide for competitive challenges to develop key strategic objectives calling for deep-tech and radical thinking. 2. The Pathfinder's transition activities shall help all types of researchers and innovators develop the pathway to commercial development in the Union, such as demonstration activities and feasibility studies to assess potential business cases, and shall support the creation of spin-offs and start-ups. The launch and the content of the calls for proposals for Pathfinder's transition activities shall be determined taking account of objectives and budget established by the work programme in relation with the portfolio of actions concerned. Additional grants for a fixed amount not exceeding EUR 50 000 may be awarded to each proposal already selected under the Pathfinder, and where relevant Pathfinder's transition activities, through a call for proposals to carry out complementary activities, including urgent coordination and support actions, for reinforcing the portfolio's community of beneficiaries, such as assessing possible spin-offs, potential market-creating innovations or developing a business plan. The Programme Committee established under the specific programme shall be informed of such cases. 3. The award criteria referred to in Article 28 shall apply to the Pathfinder. Article 48 The Accelerator 1. The Accelerator shall aim to support essentially market-creating innovation. It shall support only single beneficiaries and shall mainly provide blended finance. Under certain conditions, it may also provide grant-only and equity-only supports. The Accelerator shall provide the following types of support: (a) blended finance support to SMEs, including start-ups, and, in exceptional cases, small mid-caps, carrying out breakthrough and disruptive non-bankable innovation; (b) a grant-only support to SMEs, including start-ups, carrying out any type of innovation ranging from incremental to breakthrough and disruptive innovation and aiming to subsequently scale-up; (c) equity-only support to non-bankable SMEs, including start-ups, which have already received a grant-only support, may also be provided. Grant-only support under the Accelerator shall be provided only under the following cumulative conditions: (a) the project shall include information on the capacities and willingness of the applicant to scale-up; (b) the beneficiary shall be a start-up or an SME; (c) a grant-only support under the Accelerator shall be provided only once to a beneficiary during the period of implementation of the Programme for a maximum of EUR 2,5 million. 2. The beneficiary of the Accelerator shall be a legal entity qualifying as a start-up, an SME or in exceptional cases as a small mid-cap intending to scale up, established in a Member State or associated country. The proposal may be submitted either by the beneficiary or, subject to the prior agreement by the beneficiary, by one or more natural persons or legal entities intending to establish or support that beneficiary. In the latter case, the funding agreement shall be signed only with the beneficiary. 3. A single award decision shall cover and provide funding for all forms of Union contribution provided under EIC blended finance. 4. Proposals shall be evaluated on their individual merits by independent external experts and selected for funding through an open call for proposals with cut-off dates, based on Articles 27, 28 and 29, subject to paragraph 5 of this Article. 5. The proposals submitted shall be evaluated on the basis of the following award criteria: (a) excellence; (b) impact; (c) the level of risk of the action that would prevent investments, the quality and efficiency of the implementation, and the need for Union support. 6. With the agreement of the applicants concerned, the Commission or the funding bodies implementing the Programme (including the EIT's KICs) may directly submit for evaluation under the award criterion referred to in point (c) of paragraph 5 a proposal for an innovation and market deployment action which already fulfils the award criteria referred to in points (a) and (b) of paragraph 5, subject to the following cumulative conditions: (a) the proposal shall stem from any other action funded under Horizon 2020, from the Programme or, subject to an exploratory pilot phase to be launched under the first work programme, from national and/or regional programmes, starting with the mapping of the demand for such a scheme, detailed provisions of which shall be laid down in the specific programme referred to in point (a) of Article 1(2); (b) the proposal is based on a project review which was carried out within the previous two years assessing the excellence and the impact of the proposal and subject to conditions and processes further detailed in the work programme. 7. A Seal of Excellence may be awarded subject to the following cumulative conditions: (a) the beneficiary is a start-up, an SME or a small mid-cap; (b) the proposal was eligible and has passed the applicable thresholds for the award criteria referred to in points (a) and (b) of paragraph 5; (c) the activity would be eligible under an innovation action. 8. For a proposal having passed the evaluation, independent external experts shall propose a corresponding Accelerator support, based on the risk incurred and the resources and time necessary to bring and deploy the innovation to the market. The Commission may reject, for justified reasons, a proposal retained by independent external experts, including due to non-compliance with the objectives of Union policies. The Programme Committee shall be informed of the reasons for such a rejection. 9. The grant or the reimbursable advance component of the Accelerator support shall not exceed 70 % of the total eligible costs of the selected innovation action. 10. The conditions for implementation of the equity and the repayable support components of the Accelerator support are set out in Decision (EU) 2021/764 11. The contract for the selected action shall establish specific measurable milestones and the corresponding pre-financing and payments by instalments of the Accelerator support. In the case of EIC blended finance, activities corresponding to an innovation action may be launched and the first pre-financing of the grant or the reimbursable advance paid, prior to the implementation of other components of the awarded EIC blended finance. The implementation of those components shall be subject to reaching specific milestones established in the contract. 12. In accordance with the contract, the action shall be suspended, amended or, if duly justified, terminated if measurable milestones are not reached. It may also be terminated where the expected market deployment, especially in the Union, cannot be met. In exceptional cases and upon advice by the EIC board, the Commission may decide to increase the Accelerator support subject to a project review by independent external experts. The Programme Committee shall be informed of such cases. CHAPTER V Experts Article 49 Appointment of independent external experts 1. Independent external experts shall be identified and selected on the basis of calls for expression of interest from individuals and through calls addressed to relevant organisations such as research agencies, research institutions, universities, standardisation organisations, civil society organisations or enterprises with a view to establishing a database of candidates. By way of derogation from Article 237(3) of the Financial Regulation, the Commission or the relevant funding body may, exceptionally and in duly justified cases, select in a transparent manner any individual expert with the appropriate skills not included in the database provided that a call for expression of interest has not identified suitable independent external experts. Such experts shall declare their independence and capacity to support the objectives of the Programme. 2. In accordance with Article 237(2) and (3) of the Financial Regulation, the independent external experts shall be remunerated based on standard conditions. If justified, and in exceptional cases, an appropriate level of remuneration beyond the standard conditions based on relevant market standards, especially for specific high-level experts, may be granted. Such costs shall be covered by the Programme. 3. In addition to the information referred to in Article 38(2) and (3) of the Financial Regulation, the names of independent external experts evaluating grant applications who are appointed in a personal capacity shall be published, together with their area of expertise, at least once a year on the website of the Commission or of the funding body. Such information shall be collected, processed and published in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (33). 4. The Commission or the relevant funding body shall take the appropriate measures to prevent conflicts of interest as regards the involvement of independent external experts in accordance with Article 61 and Article 150(5) of the Financial Regulation. The Commission or the relevant funding body shall ensure that an expert faced with a conflict of interest in relation to a matter on which the expert is required to provide an opinion does not evaluate, advise or assist on the specific matter in question. 5. When appointing independent external experts, the Commission or the relevant funding body shall take appropriate measures to seek a balanced composition within the expert groups and evaluation panels in terms of skills, experience, knowledge, including in terms of specialisation, in particular on SSH, geographical diversity and gender, taking into account the situation in the field of the action. 6. Where appropriate, an adequate number of independent external experts shall be ensured for each proposal in order to guarantee the quality of the evaluation. 7. The information on the level of remuneration of all independent external experts shall be made available to the European Parliament and to the Council. TITLE III PROGRAMME MONITORING, COMMUNICATION, EVALUATION AND CONTROL Article 50 Monitoring and reporting 1. The Commission shall monitor continuously the management and implementation of the Programme, the specific programme referred to in point (a) of Article 1(2) and the activities of the EIT. In order to enhance transparency, data shall also be made publicly available in an accessible manner on the Commission's website according to the latest update. In particular, data for projects funded under ERC, European Partnerships, missions, the EIC and the EIT shall be included in the same database. The database shall include: (a) time-bound indicators to report on an annual basis on the progress of the Programme towards achievement of the objectives referred to in Article 3 and set out in Annex V along impact pathways; (b) information on the level of mainstreaming SSH, the ratio between lower and higher TRLs in collaborative research, the progress on the participation of widening countries, the geographical composition of consortia in collaborative projects, the evolution of researchers salaries, the use of a two-stage submission and evaluation procedure, the measures aimed at facilitating collaborative links in European R&I, the use of the evaluation review and the number and types of complaints, the level of climate mainstreaming and related expenditures, SME participation, private sector participation, gender participation in funded actions, evaluation panels, boards and advisory groups, the 'Seals of Excellence', the European Partnerships as well as the co-funding rate, the complementary and cumulative funding from other Union programmes, research infrastructures, time-to-grant, the level of international cooperation, engagement of citizens and civil society participation; (c) the levels of expenditure disaggregated at project level in order to allow for specific analysis, including per intervention area; (d) the level of oversubscription, in particular the number of proposals and per call for proposals, their average score, the share of proposals above and below quality thresholds. 2. To ensure the effective assessment of the Programme's progress towards the achievement of its objectives, the Commission is empowered to adopt delegated acts in accordance with Article 55 to amend Annex V with regard to the impact pathway indicators, where considered to be necessary, and to set baselines and targets as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. 3. The performance reporting system shall ensure that data for monitoring the implementation and the results of the Programme are collected efficiently, effectively and in a timely manner, without increasing the administrative burden for beneficiaries. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds, including at the level of researchers involved in the actions in order to be able to track their career and mobility, and where appropriate, on Member States. 4. Qualitative analysis from the Commission and Union or national funding bodies shall complement as much as possible quantitative data. 5. The measures aimed at facilitating collaborative links in European R&I shall be monitored and reviewed in the context of the work programmes. Article 51 Information, communication, publicity and dissemination and exploitation 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results (including for prizes), by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the Programme, to actions under the Programme and to the results obtained. In addition, it shall provide timely and thorough information to Member States and beneficiaries. Evidence-based matchmaking services informed by analytics and network affinities shall be provided to interested entities in order to form consortia for collaborative projects, with particular attention to identifying networking opportunities for legal entities from low R&I performing countries. On the basis of such analysis, targeted matchmaking events may be organised in function of specific calls for proposals. 3. The Commission shall also establish a dissemination and exploitation strategy for increasing the availability and diffusion of the Programme's R&I results and knowledge to accelerate exploitation towards market uptake and boost the impact of the Programme. 4. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union as well as information, communication, publicity, dissemination and exploitation activities insofar as those priorities are related to the objectives referred to in Article 3. Article 52 Programme evaluation 1. Programme evaluations shall be carried out in a timely manner to feed into the decision-making process of the Programme, the next framework programme and other initiatives relevant to R&I. 2. The interim evaluation of the Programme shall be carried out with the assistance of independent experts selected on the basis of a transparent process once there is sufficient information available about the implementation of the Programme, but no later than four years after the start of that implementation. It shall include a portfolio analysis and an assessment of the long-term impact of previous framework programmes and shall form the basis to adjust or re-orientate the Programme, as appropriate. It shall assess the Programme's effectiveness, efficiency, relevance, coherence, and Union added value. 3. At the end of the implementation of the Programme, but no later than four years after the end of the period specified in Article 1, a final evaluation of the Programme shall be completed by the Commission. It shall include an assessment of the long-term impact of previous framework programmes. 4. The Commission shall publish and communicate the conclusions of the evaluations accompanied by its observations and shall present them to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Article 53 Audits 1. The control system for the Programme shall ensure an appropriate balance between trust and control, taking into account administrative and other costs of controls at all levels, especially for beneficiaries. Audit rules shall be clear, consistent and coherent throughout the Programme. 2. The audit strategy for the Programme shall be based on the financial audit of a representative sample of expenditure across the Programme as a whole. The representative sample shall be complemented by a selection based on an assessment of the risks related to expenditure. Actions that receive joint funding from different Union programmes shall be audited only once, covering all programmes involved and their respective applicable rules. 3. In addition, the Commission or the relevant funding body may rely on system and processes audits at beneficiary level. Those audits shall be optional for certain types of beneficiaries and shall examine the systems and processes of a beneficiary, complemented by an audit of transactions. They shall be carried out by a competent independent auditor qualified to carry out statutory audits of accounting documents in accordance with Directive 2006/43/EC of the European Parliament and of the Council (34). The system and processes audits may be used by the Commission or the relevant funding body to determine the overall assurance on the sound financial management of expenditure and for reconsideration of the level of ex post audits and certificates on financial statements. 4. In accordance with Article 127 of the Financial Regulation, the Commission or the relevant funding body may rely on audits on the use of Union contributions carried out by other independent and competent persons or entities, including by other than those mandated by the Union institutions or bodies. 5. Audits may be carried out up to two years after the payment of the balance. 6. The Commission shall publish audit guidelines, aiming to ensure the reliable and uniform application and interpretation of the audit procedures and rules throughout the duration of the Programme. Article 54 Protection of financial interests of the Union Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. Article 55 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 50(2) shall be conferred on the Commission until 31 December 2028. 3. The delegation of power referred to in Article 50(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 50(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. TITLE IV TRANSITIONAL AND FINAL PROVISIONS Article 56 Repeal Regulations (EU) No 1290/2013 and (EU) No 1291/2013 are repealed with effect from 1 January 2021. Article 57 Transitional provisions 1. This Regulation shall not affect the continuation of or modification of actions initiated pursuant to Regulations (EU) No 1290/2013 and (EU) No 1291/2013, which shall continue to apply to those actions until their closure. Work plans and actions provided for in work plans adopted under Regulation (EU) No 1290/2013 and under the corresponding funding bodies' basic acts shall also continue to be governed by Regulation (EU) No 1290/2013 and those basic acts until their completion. 2. The financial envelope for the Programme may also cover technical and administrative assistance expenses necessary to ensure the transition between the Programme and the measures adopted pursuant to Regulation (EU) No 1291/2013. Article 58 Entry into force This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 28 April 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 62, 15.2.2019, p. 33 and OJ C 364, 28.10.2020, p. 124. (2) OJ C 461, 21.12.2018, p. 79. (3) Position of the European Parliament of 17 April 2019 (not yet published in the Official Journal) and position of the Council at first reading of 16 March 2021 (not yet published in the Official Journal). Position of the European Parliament of … (not yet published in the Official Journal). (4) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433 I, 22.12.2020, p. 11). (5) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433 I, 22.12.2020, p. 23). (6) OJ L 282, 19.10.2016, p. 4. (7) Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC (OJ L 347, 20.12.2013, p. 104). (8) OJ C 331, 18.9.2018, p. 30. (9) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (10) Regulation (EU) 2021/697 of the European Parliament and of the Council of 29 April 2021 establishing the European Defence Fund and repealing Regulation (EU) 2018/1092 (see page 149 of this Official Journal). (11) Council Decision (EU) 2021/764 of 10 May 2021 on establishing the specific programme implementing Horizon Europe – the Framework Programme for Research and Innovation, and repealing Decision 2013/743/EU (OJ LI 167, 12.5.2021, p. 1). (12) OJ L 433 I, 22.12.2020, p. 28. (13) OJ C 444 I, 22.12.2020, p. 1. (14) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (15) Communication from the Commission of 14 February 2018 entitled 'A new, modern Multiannual Financial Framework for a European Union that deliver efficiently on its priorities post-2020' identifies EUR 13 billion spent in main digital activities under the Research and Innovation Framework Programme Horizon 2020. (16) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (17) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (18) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (19) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor's Office ('the EPPO') (OJ L 283, 31.10.2017, p. 1). (20) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union's financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (21) OJ L 1, 3.1.1994, p. 3. (22) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union ('Overseas Association Decision') (OJ L 344, 19.12.2013, p. 1). (23) OJ L 123, 12.5.2016, p. 1. (24) OJ C 205, 19.7.2013, p. 9. (25) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). (26) Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in 'Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020)' and repealing Regulation (EC) No 1906/2006 (OJ L 347, 20.12.2013, p. 81). (27) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (28) Research relating to cancer treatment of the gonads can be financed. (29) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). (30) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243). (31) The procedure will be explained in a document published before the start of the evaluation process. (32) Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) (OJ L 412, 30.12.2006, p. 1). (33) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). (34) Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directives 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ L 157, 9.6.2006, p. 87). ANNEX I BROAD LINES OF ACTIVITIES The general and specific objectives referred to in Article 3 of this Regulation shall be pursued across the Programme, through the areas of intervention and the broad lines of activities described in this Annex and in Annex II to this Regulation, as well as in Annex I to Decision (EU) 2021/764. (1) Pillar I 'Excellent Science' Through the following activities, this pillar shall, in line with Article 4, promote scientific excellence, attract the best talent to Europe, provide appropriate support to early-stage researchers and support the creation and diffusion of scientific excellence, high-quality knowledge, methodologies and skills, technologies and solutions to global social, environmental and economic challenges. It shall also contribute to the other specific objectives of the Programme as referred to in Article 3. (a) ERC: providing attractive and flexible funding to enable talented and creative individual researchers, with an emphasis on early stage researchers, and their teams to pursue the most promising avenues at the frontier of science, regardless of their nationality and country of origin and on the basis of Union-wide competition based solely on the criterion of excellence. Area of intervention: Frontier science. (b) MSCA: equipping researchers with new knowledge and skills through mobility and exposure across borders, sectors and disciplines, enhancing training and career development systems as well as structuring and improving institutional and national recruitment, taking into account the European Charter for Researchers and the Code of Conduct for the recruitment of researchers; in so doing, the MSCA help to lay the foundations of Europe's excellent research landscape across the whole of Europe, contributing to boosting jobs, growth, and investment, and solving current and future societal challenges. Areas of intervention: nurturing excellence through the mobility of researchers across borders, sectors and disciplines; fostering new skills through the excellent training of researchers; strengthening human resources and skills development across the ERA; improving and facilitating synergies; promoting public outreach. (c) Research infrastructures: endowing Europe with world-class sustainable research infrastructures which are open and accessible to the best researchers from Europe and beyond. Encouraging the use of existing research infrastructures, including those financed from funds under Union Cohesion Policy. In so doing, enhancing the potential of the research infrastructure to support scientific advance and innovation, and to enable open and excellent science in accordance with the FAIR principles, alongside activities related to Union policies and international cooperation. Areas of intervention: consolidating and developing the landscape of European research infrastructures; opening, integrating and interconnecting research infrastructures; the innovation potential of European research infrastructures and activities for innovation and training; reinforcing European research infrastructure policy and international cooperation. (2) Pillar II 'Global Challenges and European Industrial Competitiveness' Through the following activities, this pillar shall, in line with Article 4, support the creation and better diffusion of high-quality new knowledge, technologies and sustainable solutions, reinforce the European industrial competitiveness, strengthen the impact of R&I in developing, supporting and implementing Union policies, and support the uptake of innovative solutions in industry, in particular in SMEs and start-ups, and society to address global challenges. It shall also contribute to the other specific objectives of the Programme as referred to in Article 3. SSH shall be fully integrated across all clusters, including specific and dedicated activities. To maximise impact, flexibility and synergies, R&I activities shall be organised in six clusters, interconnected through pan-European research infrastructures, which individually and together incentivise interdisciplinary, cross-sectoral, cross-policy, cross-border and international cooperation. Pillar II of the Programme shall cover activities from a broad range of TRLs, including lower TRLs. Each cluster contributes towards several SDGs and many SDGs are supported by more than one cluster. The R&I activities shall be implemented in and across the following clusters: (a) Cluster 'Health': improving and protecting the health and well-being of citizens of all ages by generating new knowledge, developing innovative solutions, ensuring to integrate, where relevant, a gender perspective to prevent, diagnose, monitor, treat and cure diseases, and developing health technologies; mitigating health risks; protecting populations and promoting good health and well-being, also in the work place; making public health systems more cost-effective, equitable and sustainable; preventing and tackling poverty-related diseases; and supporting and enabling patients' participation and self-management. Areas of intervention: health throughout the life course; environmental and social health determinants; non-communicable and rare diseases; infectious diseases, including poverty-related and neglected diseases; tools, technologies and digital solutions for health and care, including personalised medicine; health care systems. (b) Cluster 'Culture, Creativity and Inclusive Society': strengthening democratic values, including rule of law and fundamental rights; safeguarding our cultural heritage; exploring the potential of cultural and creative sectors, and promoting socio-economic transformations that contribute to inclusion and growth, including migration management and integration of migrants. Areas of intervention: democracy and governance; culture, cultural heritage and creativity; social and economic transformations. (c) Cluster 'Civil Security for Society': responding to the challenges arising from persistent security threats, including cybercrime, as well as natural and man-made disasters. Areas of intervention: disaster-resilient societies; protection and security; cybersecurity. (d) Cluster 'Digital, Industry and Space': reinforcing capacities and securing Europe's sovereignty in key enabling technologies for digitisation and production, and in space technology, all along the value chain; to build a competitive, digital, low-carbon and circular industry; ensure a sustainable supply of raw materials; develop advanced materials and provide the basis for advances and innovation in global societal challenges. Areas of intervention: manufacturing technologies; key digital technologies, including quantum technologies; emerging enabling technologies; advanced materials; artificial intelligence and robotics; next generation internet; advanced computing and Big Data; circular industries; low carbon and clean industries; space, including earth observation. (e) Cluster 'Climate, Energy and Mobility': fighting climate change by better understanding its causes, evolution, risks, impacts and opportunities, by making the energy and transport sectors more climate and environment-friendly, more efficient and competitive, smarter, safer and more resilient, promote the use of renewable energy sources and energy efficiency, improve the resilience of the Union to external shocks and adapt social behaviour in view of the SDGs. Areas of intervention: climate science and solutions; energy supply; energy systems and grids; buildings and industrial facilities in energy transition; communities and cities; industrial competitiveness in transport; clean, safe and accessible transport and mobility; smart mobility; energy storage. (f) Cluster 'Food, Bioeconomy, Natural Resources, Agriculture and Environment': protecting the environment, restoring, sustainably managing and using natural and biological resources from land, inland waters and sea to stop biodiversity erosion, to address food and nutrition security for all and the transition to a low carbon, resource efficient and circular economy and sustainable bioeconomy. Areas of intervention: environmental observation; biodiversity and natural resources; agriculture, forestry and rural areas; seas, oceans and inland waters; food systems; bio-based innovation systems in the Union's bioeconomy; circular systems. (g) Non-nuclear direct actions of the JRC: generating high-quality scientific evidence for efficient and affordable good public policies. New initiatives and proposals for Union legal acts need transparent, comprehensive and balanced evidence to be sensibly designed, whereas implementation of policies needs evidence to be measured and monitored. The JRC provides Union policies with independent scientific evidence and technical support throughout the policy cycle. The JRC focuses its research on Union policy priorities. Areas of intervention: strengthening the knowledge base for policy making; global challenges (health; culture, creativity and inclusive society; civil security for society; digital, industry and space; climate, energy and mobility; food, bioeconomy, natural resources, agriculture and environment); innovation, economic development, and competitiveness; scientific excellence; territorial development and support for Member States and regions. (3) Pillar III 'Innovative Europe' Through the following activities, this pillar shall, in line with Article 4, foster all forms of innovation, including non-technological innovation, primarily within SMEs including start-ups, by facilitating technological development, demonstration and knowledge transfer, and strengthen deployment of innovative solutions. It shall also contribute to the other specific objectives of the Programme as referred to in Article 3. The EIC shall be implemented primarily through two instruments, the Pathfinder, implemented mainly through collaborative research, and the Accelerator. (a) EIC: focusing mainly on breakthrough and disruptive innovation, targeting especially market-creating innovation, while also supporting all types of innovation, including incremental innovation. Areas of intervention: Pathfinder for advanced research, supporting future and emerging breakthrough, market-creating and/or deep tech technologies; the Accelerator, bridging the financing gap between late stages of R&I activities and market take-up, to effectively deploy breakthrough, market-creating innovation and scale up companies where the market does not provide viable financing; additional EIC activities such as prizes and fellowships, and business added-value services. (b) European innovation ecosystems Areas of intervention: activities including in particular connecting, where relevant in cooperation with the EIT, with national and regional innovation actors and supporting the implementation of joint cross-border innovation programmes by Member States, Regions and associated countries, from the exchange of practice and knowledge on innovation regulation to the enhancement of soft skills for innovation to research and innovation activities, including open or user-led innovation, to boost the effectiveness of the European innovation system. This should be implemented in synergy with, among others, the ERDF support for innovation eco-systems and interregional partnerships around smart specialisation topics. (c) The European Institute of Innovation and Technology Areas of intervention (defined in Annex II): sustainable innovation ecosystems across Europe; innovation and entrepreneurial skills in a lifelong learning perspective, including increasing capacities of higher education institutions across Europe; new solutions to market to address global challenges; synergies and value added within the Programme. (4) Part 'Widening Participation and Strengthening the ERA' Through the following activities, this part shall pursue the specific objectives as set out in point (d) of Article 3(2). It shall also contribute to the other specific objectives of the Programme as referred to in Article 3. While underpinning the entire Programme, this part shall support activities that contribute to attracting talent, fostering brain circulation and preventing brain drain, a more knowledge-based and innovative and gender-equal Europe, at the front edge of global competition, fostering transnational cooperation and thereby optimising national strengths and potential across the whole Europe in a well-performing ERA, where knowledge and a highly skilled workforce circulate freely in a balanced manner, where the results of R&I are widely disseminated to as well as understood and trusted by informed citizens and benefit society as a whole, and where Union policy, in particular R&I policy, is based on high quality scientific evidence. This Part shall also support activities aimed at improving the quality of proposals from legal entities from low R&I performing countries, such as professional pre-proposal checks and advice, and boosting the activities of National Contact Points to support international networking, as well as activities aimed at supporting legal entities from low R&I performing countries joining already selected collaborative projects in which legal entities from such countries are not participating. Areas of intervention: widening participation and spreading excellence, including through teaming, twinning, ERA-Chairs, European Cooperation in Science and Technology (COST), excellence initiatives and activities to foster brain circulation; reforming and enhancing the European R&I system, including through for example supporting national R&I policy reform, providing attractive career environments, and supporting gender and citizen science. ANNEX II EUROPEAN INSTITUTE OF INNOVATION AND TECHNOLOGY (EIT) The following shall apply in the implementation of the programme activities of the EIT: (1) Rationale As the report of the High Level Group on maximising the impact of Union R&I (the Lamy High Level Group) clearly states, the way forward is 'to educate for the future and invest in people who will make the change'. In particular, European higher education institutions are called to stimulate entrepreneurship, tear down disciplinary borders and institutionalise strong inter-disciplinary academia-industry collaborations. According to recent surveys, access to talented people is by far the most important factor influencing the location choices of European founders of start-ups. Entrepreneurship education, training opportunities and the development of creative skills play a key role in cultivating future innovators and in developing the abilities of existing ones to grow their business to greater levels of success. Access to entrepreneurial talent, together with access to professional services, capital and markets on the Union level, and bringing key innovation actors together around a common goal are key ingredients for nurturing an innovation ecosystem. There is a need to coordinate efforts across the Union in order to create a critical mass of interconnected Union-wide entrepreneurial clusters and ecosystems. The EIT is today's Europe's largest integrated innovation ecosystem which brings together partners from business, research, education and beyond. The EIT continues to support its KICs, which are large-scale European Partnerships addressing specific global challenges, and strengthen the innovation ecosystems around them. It does so by fostering the integration of education, R&I of the highest standards, thereby creating environments conducive to innovation, and by promoting and supporting a new generation of entrepreneurs and stimulating the creation of innovative companies in close synergy and complementarity with the EIC. Throughout Europe, efforts are still needed to develop ecosystems where researchers, innovators, industries and governments can easily interact. Innovation ecosystems, in fact, still do not work optimally due to a number of reasons such as: (a) interaction among innovation players is still hampered by organisational, regulatory and cultural barriers between them; (b) efforts to strengthen innovation ecosystems shall benefit from coordination and a clear focus on specific objectives and impact. To address future societal challenges, embrace the opportunities of new technologies and contribute to environmentally friendly and sustainable economic growth, jobs, competitiveness and the well-being of Europe's citizens, there is the need to further strengthen Europe's capacity to innovate by: strengthening existing and fostering the creation of new environments conducive to collaboration and innovation; strengthening the innovation capabilities of academia and the research sector; supporting a new generation of entrepreneurial people; stimulating the creation and the development of innovative ventures, as well as strengthening the visibility and recognition of Union funded R&I activities, in particular the EIT funding to the wider public. The nature and scale of the innovation challenges require liaising and mobilising players and resources at European scale, by fostering cross-border collaboration. There is a need to break down silos between disciplines and along value chains and nurture the establishment of a favourable environment for an effective exchange of knowledge and expertise, and for the development and attraction of entrepreneurial talents. The Strategic Innovation Agenda of the EIT shall ensure coherence with the challenges of the Programme, as well as complementarity to the EIC. (2) Areas of Intervention 2.1. Sustainable innovation ecosystems across Europe In accordance with the EIT Regulation and the Strategic Innovation Agenda of the EIT, the EIT plays a reinforced role in strengthening sustainable challenges-based innovation ecosystems throughout Europe. In particular, the EIT continues to operate primarily through its KICs, the large-scale European Partnerships that address specific societal challenges. It continues to strengthen innovation ecosystems around them, by opening them up and by fostering the integration of research, innovation and education. Furthermore, the EIT strengthens innovation ecosystems throughout Europe by expanding its Regional Innovation Scheme (RIS). The EIT works with innovation ecosystems that exhibit high innovation potential based on strategy, thematic alignment and envisaged impact, in close synergy with smart specialisation strategies and Platforms. Broad lines (a) reinforcing the effectiveness and the openness to new partners of the existing KICs, enabling the transition to self-sustainability in the long-term and analysing the need of setting up new ones to tackle global challenges. The specific thematic areas are defined in the Strategic Innovation Agenda of the EIT, taking into account the strategic planning; (b) accelerating regions towards excellence in countries that are referred to in the Strategic Innovation Agenda of the EIT in close cooperation with structural funds and other relevant Union programmes where appropriate. 2.2. Innovation and entrepreneurial skills in a lifelong learning perspective, including increasing capacities of higher education institutions across Europe The EIT education activities are reinforced to foster innovation and entrepreneurship through purposeful education and training. A stronger focus on human capital development is based on the expansion of the EIT's KICs existing education programmes in the view of continuing to offer students and professionals high quality curricula based on innovation, creativity and entrepreneurship in line in particular with the Union's industrial and skills strategy. This may include researchers and innovators supported by other parts of the Programme, in particular MSCA. The EIT also supports the modernisation of higher education institutions across Europe and their integration in innovation ecosystems by stimulating and increasing their entrepreneurial potential and capabilities and encouraging them to better anticipate new skills requirements. Broad lines (a) development of innovative curricula, taking into account the future needs of society and industry, and cross-cutting programmes to be offered to students, entrepreneurs and professionals across Europe and beyond where specialist and sector specific knowledge is combined with innovation-oriented and entrepreneurial skills, such as high-tech skills related to digital and sustainable key enabling technologies; (b) strengthening and expanding the EIT label in order to improve the visibility and the recognition of EIT education programmes based on partnerships between different higher education institutions, research centres and companies while enhancing its overall quality by offering learning-by-doing curricula and purposeful entrepreneurship education as well as international, inter-organisational and cross-sectorial mobility; (c) development of innovation and entrepreneurship capabilities of the higher education sector, by leveraging and promoting the EIT community expertise in linking education, research and business; (d) reinforcing the role of the EIT Alumni community as role model for new students and strong instrument to communicate EIT impact. 2.3. New solutions to the market to address global challenges The EIT facilitates, empowers and awards entrepreneurs, innovators, researchers, educators, students and other innovation actors, while ensuring gender mainstreaming, to work together in cross-disciplinary teams to generate ideas and transform them into both incremental and disruptive innovations. Activities are characterised by an open innovation and cross-border approach, with a focus on including relevant Knowledge Triangle activities that are pertinent to making them a success (such as project's promoters can improve their access to specifically qualified graduates, lead users, start-ups with innovative ideas, non-domestic firms with relevant complementary assets etc.). Broad lines (a) support the development of new products, services and market opportunities where Knowledge Triangle actors collaborate to bring solutions to global challenges; (b) fully integrate the entire innovation value chain: from student to entrepreneur, from idea to product, from lab to customer. This includes support for start-ups and scaling-up businesses; (c) provision of high-level services and support to innovative businesses, including technical assistance to fine-tuning of products or services, substantive mentoring, support to secure target customers and raise capital, in order to swiftly reach the market and speed up their growth process. 2.4. Synergies and value added within the Programme The EIT steps up its efforts to capitalise on synergies and complementarities between existing KICs and with different actors and initiatives at Union and global levels and extend its network of collaborating organisations at both strategic and operational levels, while avoiding duplications. Broad lines (a) close cooperation with the EIC and the InvestEU Programme in streamlining the support (namely funding and services) offered to innovative ventures in both start-up and scale-up stages, in particular through KICs; (b) planning and implementation of EIT activities in order to maximise synergies and complementarities with other parts of the Programme; (c) engage with Member States, at both national and regional level, establishing a structured dialogue and coordinating efforts to enable synergies with national and regional initiatives, including smart specialisation strategies, also considering through the implementation of the 'European innovation ecosystems', in order to identify, share and disseminate best practices and learnings; (d) share and disseminate innovative practices and learnings throughout Europe and beyond, so as to contribute to innovation policy in Europe in coordination with other parts of the Programme; (e) provision of input to innovation policy discussions and contribution to the design and implementation of Union policy priorities by continuously working with all relevant Commission services, other Union programmes and their stakeholders, and further exploring opportunities within policy implementing initiatives; (f) exploitation of synergies with other Union programmes, including those supporting human capital development and innovation (such as COST, ESF+, ERDF, Erasmus+, Creative Europe and COSME Plus/Single Market, the InvestEU Programme); (g) building strategic alliances with key innovation actors at Union and international level, and support to KICs to develop collaboration and linkages with key Knowledge Triangle partners from third countries, with the aim of opening new markets for KICs'-backed solutions and attract financing and talents from abroad. Participation of third countries shall be promoted with regard to the principles of reciprocity and mutual benefits. ANNEX III EUROPEAN PARTNERSHIPS European Partnerships shall be selected and implemented, monitored, evaluated, phased-out or renewed on the basis of the following criteria: 1. Selection Demonstrating that the European Partnership is more effective in achieving the related objectives of the Programme through involvement and commitment of partners, in particular in delivering clear impacts for the Union and its citizens, in particular in view of delivering on global challenges and R&I objectives, securing Union competitiveness, sustainability and contributing to the strengthening of the ERA and, where relevant, international commitments. In the case of Institutionalised European Partnerships established in accordance with Article 185 TFEU, the participation of at least 40 % of the Member States is mandatory: (a) coherence and synergies of the European Partnership within the Union R&I landscape, following the Programme's rules to the largest extent possible; (b) transparency and openness of the European Partnership as regards the identification of priorities and objectives in terms of expected results and impacts and as regards the involvement of partners and stakeholders from across the entire value chain, from different sectors, backgrounds and disciplines, including international ones when relevant and not interfering with European competitiveness; clear arrangements for promoting participation of SMEs and for disseminating and exploiting results, in particular by SMEs, including through intermediary organisations; (c) ex ante demonstration of additionality and directionality of the European Partnership, including a common strategic vision of the purpose of the European Partnership. That vision includes in particular: (i) identification of measurable expected outcomes, results and impacts within specific timeframes, including key economic and/or societal value for the Union; (ii) demonstration of expected qualitative and significant quantitative leverage effects, including a method for the measurement of key performance indicators; (iii) approaches to ensure flexibility of implementation and to adjust to changing policy, societal and/or market needs, or scientific advances, to increase policy coherence between regional, national and Union level; (iv) exit-strategies and measures for phasing-out from the Programme; (d) ex ante demonstration of the partners' long-term commitment, including a minimum share of public and/or private investments. In the case of Institutionalised European Partnerships, established in accordance with Article 185 or 187 TFEU, the financial and/or in-kind contributions from partners other than the Union, is at least equal to 50 % and may reach up to 75 % of the aggregated European Partnership budgetary commitments. For each such Institutionalised European Partnership, a share of the contributions from partners other than the Union will be in the form of financial contributions. For partners other than the Union and participating states, financial contributions should be aimed primarily at covering administrative costs as well as coordination and support and other non-competitive activities. 2. Implementation: (a) systemic approach ensuring active and early involvement of Member States and achievement of the expected impacts of the European Partnership through the flexible implementation of joint actions of high Union added value also going beyond joint calls for proposals for R&I activities, including those related to market, regulatory or policy uptake; (b) appropriate measures ensuring continuous openness of the initiative and transparency during implementation, in particular for priority setting and for participation in calls for proposals, information on the functioning of the governance, visibility of the Union, communication and outreach measures, dissemination and exploitation of results, including clear open access/user strategy along the value chain; appropriate measures for informing SMEs and promoting their participation; (c) coordination or joint activities with other relevant R&I initiatives to secure optimum level of interconnections and ensure effective synergies, among other things, to overcome potential implementation barriers at national level and increase cost-effectiveness; (d) commitments, for financial and/or in-kind contributions, from each partner in accordance with national provisions throughout the duration of the initiative; (e) in the case of Institutionalised European Partnership access to the results and other action related information for the Commission for the purpose of developing, implementing and monitoring of Union policies or programmes. 3. Monitoring: (a) a monitoring system in accordance with Article 50 to track progress towards specific policy objectives, deliverables and key performance indicators allowing for an assessment over time of achievements, impacts and potential needs for corrective measures; (b) periodic dedicated reporting on quantitative and qualitative leverage effects, including on committed and actually provided financial and in-kind contributions, visibility and positioning in the international context, impact on R&I related risks of private sector investments; (c) detailed information on the evaluation process and results from all calls for proposals within European Partnerships, to be made available timely and accessible in a common e-database. 4. Evaluation, phasing-out and renewal: (a) evaluation of impacts achieved at Union and national level in relation to defined targets and key performance indicators, feeding into the Programme evaluation set out in Article 52, including an assessment of the most effective policy intervention mode for any future action; and the positioning of any possible renewal of a European Partnership in the overall European Partnerships landscape and its policy priorities; (b) in the absence of renewal, appropriate measures ensuring phasing-out of the Programme funding according to the conditions and timeline agreed with the legally committed partners ex ante, without prejudice to possible continued transnational funding by national or other Union programmes, and without prejudice to private investment and on-going projects. ANNEX IV SYNERGIES WITH OTHER UNION PROGRAMMES Synergies with other Union programmes are based on complementarity between programme design and objectives and on compatibility of financing rules and processes at implementation level. Funding from the Programme shall be used only to finance R&I activities. The strategic planning shall ensure the alignment of priorities for the different Union programmes and ensure coherent funding options at different stages of the R&I cycle. Missions and European Partnerships shall, among other things, benefit from synergies with other Union programmes and policies. The deployment of research results and innovative solutions developed in the Programme shall be facilitated with the support of other Union programmes, in particular through dissemination and exploitation strategies, transfer of knowledge, complementary and cumulative funding sources and accompanying policy measures. Funding for R&I activities shall profit from harmonised rules that are designed to ensure Union added value, to avoid overlaps with different Union programmes and to seek maximum efficiency and administrative simplification. More detail as to how the synergies shall apply between the Programme and the different Union programmes is set out in the following paragraphs: 1. Synergies with the European Agricultural Guarantee Fund (EAGF) and the European Agricultural Fund for Rural Development (EAFRD) under the Common Agricultural Policy (CAP) shall ensure that: (a) the R&I needs of the agricultural sector and of rural areas within the Union are identified, for example, within the European Innovation Partnership 'Agricultural Productivity and Sustainability' and taken into consideration in both the Programme's strategic planning and the work programmes; (b) the CAP makes the best use of R&I results and promotes the use, implementation and deployment of innovative solutions, including those stemming from projects funded by the framework programmes for R&I, from the European Innovation Partnership 'Agricultural Productivity and Sustainability' and relevant KICs of the EIT; (c) the EAFRD supports the uptake and dissemination of knowledge and solutions stemming from the Programme's results leading to a more dynamic farming sector and new openings for the development of rural areas. 2. Synergies with the European Maritime, Fisheries and Aquaculture Fund (EMFAF) shall ensure that: (a) the Programme and the EMFAF are closely interlinked, since Union R&I needs in the field of marine and integrated maritime policy are translated through the Programme's strategic planning; (b) the EMFAF supports the rolling out of novel technologies and innovative products, processes and services, in particular those resulting from the Programme in the fields of marine and integrated maritime policy; the EMFAF also promotes ground data collection, processing and monitoring, and disseminates relevant actions supported under the Programme, which in turn contributes to the implementation of the Common Fisheries Policy, the EU Integrated Maritime Policy, International Ocean Governance and international commitments. 3. Synergies with the European Regional Development Fund (ERDF) shall ensure that: (a) with the aim of strengthening the ERA and of contributing to the SDGs, arrangements for alternative and cumulative funding from ERDF and the Programme support activities that provide a bridge, in particular, between smart specialisation strategies and excellence in R&I, including joint trans-regional/trans-national programmes and pan European Research Infrastructures; (b) the ERDF focuses, among other things, on the development and strengthening of regional and local R&I ecosystems, networks and industrial transformation, including support to building R&I capacities, to the take-up of results and to the rolling out of novel technologies and innovative and climate-friendly solutions from the framework programmes for R&I through the ERDF. 4. Synergies with the European Social Fund Plus (ESF+) shall ensure that: (a) through national or regional programmes, the ESF+ can mainstream and scale up innovative curricula supported by the Programme, in order to equip people with the skills and competences needed for evolving demands of the labour market; (b) arrangements for alternative and combined funding from ESF+ can be used to support activities of the Programme that promote human capital development in R&I with the aim of strengthening the ERA; (c) the ESF+ mainstreams innovative technologies and new business models and solutions, in particular those resulting from the Programme, so as to contribute to innovative, efficient and sustainable health systems and facilitate access to better and safer healthcare for European citizens. 5. Synergies with the EU4Health Programme shall ensure that: (a) Union R&I needs in the field of health are identified and established through the Programme's strategic planning; (b) the EU4Health Programme contributes to ensuring best use of research results, in particular those resulting from the Programme. 6. Synergies with the Connecting Europe Facility (CEF) shall ensure that: (a) the R&I needs in the areas of transport, energy and in the digital sector within the Union are identified and established through the Programme's strategic planning; (b) the CEF supports the large-scale roll-out and deployment of innovative new technologies and solutions in the fields of transport, energy and digital physical infrastructures, in particular those resulting from the framework programmes for R&I; (c) the exchange of information and data between the Programme and CEF projects are facilitated, for example by highlighting technologies from the Programme with a high market readiness that could be further deployed through the CEF. 7. Synergies with the Digital Europe Programme (DEP) shall ensure that: (a) whereas several thematic areas addressed by the Programme and DEP converge, the type of actions to be supported, their expected results and their intervention logic are different and complementary; (b) the R&I needs related to digital aspects of the Programme are identified and established through its strategic planning; this includes, for example, R&I for high performance computing, artificial intelligence, cybersecurity, distributed ledger technologies, quantum technologies combining digital with other enabling technologies and non-technological innovations; support for the scale-up of companies introducing breakthrough innovations (many of which combine digital and physical technologies); and support to digital research infrastructures; (c) DEP focuses on large-scale digital capacity and infrastructure building in, for example, high performance computing, artificial intelligence, cybersecurity, distributed ledger technologies, quantum technologies and advanced digital skills aiming at wide uptake and deployment across the Union of critical existing or tested innovative digital solutions within a Union framework in areas of public interest (such as health, public administration, justice and education) or market failure (such as the digitisation of businesses, in particular SMEs); DEP is mainly implemented through coordinated and strategic investments with Member States, in particular through joint public procurement, in digital capacities to be shared across the Union and in Union-wide actions that support interoperability and standardisation as part of developing the Digital Single Market; (d) DEP capacities and infrastructures are made available to the R&I community, including for activities supported under the Programme including testing, experimentation and demonstration across all sectors and disciplines; (e) novel digital technologies developed through the Programme are to be progressively taken up and deployed by DEP; (f) the Programme's initiatives for the development of skills and competencies curricula, including those delivered at the relevant EIT KICs, are complemented by DEP supported capacity-building in advanced digital skills; (g) strong coordination mechanisms for strategic programming, operating procedures and governance structures exist for both programmes. 8. Synergies with the Single Market Programme shall ensure that: (a) the Single Market Programme addresses the market failures which affect SMEs and promotes entrepreneurship and the creation and growth of companies, and complementarity exists between the Single Market Programme and the actions of both the EIT and the EIC for innovative companies, as well as in the area of support services for SMEs, in particular where the market does not provide viable financing; (b) the Enterprise Europe Network may serve, in addition to other existing SME support structures (e.g. National Contact Points, Innovation Agencies, Digital Innovation Hubs, Competence Centres, incubators), to deliver support services under the Programme, including the EIC. 9. Synergies with the LIFE - Programme for Environment and Climate Action (LIFE) shall ensure that: (a) the R&I needs to tackle environmental, climate and energy challenges within the Union are identified and established through the Programme's strategic planning; (b) LIFE continues to act as a catalyst for implementing the Union's environment, climate and relevant energy policy and legislation, including by taking up and applying R&I results from the Programme and help deploying them at national, interregional and regional scale where it can help address environmental, climate or clean energy transition issues. In particular LIFE continues to incentivise synergies with the Programme through the award of a bonus during the evaluation for proposals which feature the uptake of results from the Programme; (c) LIFE standard action projects support the development, testing or demonstration of suitable technologies or methodologies for the implementation of the Union's environment and climate policy, which can subsequently be deployed on a large scale, funded by other sources, including by the Programme. The EIT as well as the EIC can provide support to scale up and commercialise new breakthrough ideas that may result from the implementation of LIFE projects. 10. Synergies with Erasmus+ shall ensure that: (a) combined resources from the Programme, including from the EIT, and Erasmus+ are used to support activities dedicated to strengthening, modernising and transforming European higher education institutions. Where appropriate, the Programme complements the Erasmus+'s support for the European Universities Initiative in its research dimension, as part of the development of new joint and integrated long-term and sustainable strategies on education, R&I based on trans-disciplinary and cross-sectoral approaches to make the knowledge triangle a reality. The EIT's activities could complement the strategies to be implemented by the European Universities Initiative; (b) the Programme and Erasmus+ foster the integration of education and research through assisting higher education institutions to formulate and set up common education, R&I strategies and networks, through informing education systems, teachers and trainers of the latest findings and practices in research and in offering active research experience to all students and higher education staff and in particular researchers, and to support other activities that integrate higher education and R&I. 11. Synergies with the Union Space Programme shall ensure that: (a) the R&I needs of the Union Space Programme and those of the space upstream and downstream sector within the Union are identified and established as part of the Programme's strategic planning; space research actions implemented through the Programme are implemented with regard to procurement and eligibility of legal entities in accordance with the Union Space Programme, where appropriate; (b) space data and services made available as a public good by the Union Space Programme are used to develop breakthrough solutions through R&I, including in the Programme, in particular for sustainable food and natural resources, climate monitoring, atmosphere, land, coastal and marine environment, smart cities, connected and automated mobility, security and disaster management; (c) the Copernicus Data and Information Access Services contribute to the EOSC and thus facilitate access to Copernicus data for researchers, scientists and innovators; research infrastructures, in particular in situ observing networks constitute essential elements of the in situ observation infrastructure enabling the Copernicus services, and in turn, they benefit from information produced by Copernicus services. 12. Synergies with the Neighbourhood, Development and International Cooperation Instrument (NDICI) and the Instrument for Pre-accession Assistance (IPA III) shall ensure that: (a) the R&I needs in the areas of NDICI and IPA III are identified through the Programme's strategic planning, in line with the SDGs; (b) the Programme's R&I activities, with the participation of third countries and targeted international cooperation actions, seek alignment and coherence with parallel market uptake and capacity-building actions strands under the NDICI and IPA III, based on joint definition of needs and of areas of intervention. 13. Synergies with the Internal Security Fund and the instrument for border management as part of the Integrated Border Management Fund shall ensure that: (a) the R&I needs in the areas of security and integrated border management are identified and established through the Programme's strategic planning; (b) the Internal Security Fund and the Integrated Border Management Fund support the deployment of innovative new technologies and solutions, in particular those resulting from the framework programmes for R&I in the field of security research. 14. Synergies with the InvestEU Programme shall ensure that: (a) the Programme provides Horizon Europe blended finance and EIC blended finance for innovators, characterised by a high level of risk and for which the market does not provide sufficient and viable financing; at the same time, the Programme supports the effective delivery and management of the private part of blended finance through funds and intermediaries supported by the InvestEU Programme and others; (b) financial instruments for R&I and SMEs are grouped together under the InvestEU Programme, in particular through a dedicated R&I thematic window, and through products deployed under the SME window, thereby helping to deliver the objectives of both programmes as well as establishing strong complementary links between both programmes; (c) the Programme provides appropriate support to help the reorientation of bankable projects, not suitable for EIC funding, towards the InvestEU Programme, where relevant. 15. Synergies with the Innovation Fund under the Emission Trading Scheme (the 'Innovation Fund') shall ensure that: (a) the Innovation Fund specifically targets innovation in low-carbon technologies and processes, including environmentally safe carbon capture and utilisation that contributes substantially to mitigate climate change, as well as products substituting carbon intensive ones, and to help stimulate the construction and operation of projects that aim towards the environmentally safe capture and geological storage of CO2 as well as innovative renewable energy and energy storage technologies, and to enable and to incentivise 'greener' products; (b) the Programme funds the development and demonstration of technologies, including breakthrough solutions, that can deliver on the Union's climate neutrality, energy and industrial transformation objectives, especially through its Pillar II and Pillar III activities; (c) the Innovation Fund may, subject to fulfilment of its selection and award criteria, support the demonstration phase of eligible projects that may have received the support from the Programme and strong complementary links shall be established between both programmes. 16. Synergies with the Just Transition Mechanism shall ensure that: (a) R&I needs are identified through the Programme's strategic planning to support a just and fair transition towards climate-neutrality; (b) the take-up and deployment of innovative and climate-friendly solutions, in particular those resulting from the Programme, are promoted. 17. Synergies with the Euratom Research and Training Programme shall ensure that: (a) the Programme and the Euratom Research and Training Programme develop comprehensive actions supporting education and training (including MSCA) with the aim of maintaining and developing relevant skills in Europe; (b) the Programme and the Euratom Research and Training Programme develop joint research actions focussing on cross-cutting aspects of the safe and secure use of non-power applications of ionising radiation in sectors such as medicine, industry, agriculture, space, climate change, security and emergency preparedness and contribution of nuclear science. 18. Potential synergies with the European Defence Fund shall benefit civil and defence research with a view to avoiding unnecessary duplication and in accordance with Article 5 and Article 7(1). 19. Synergies with the Creative Europe Programme shall be fostered by identifying R&I needs in the field of cultural and creative policies in the Programme's strategic planning. 20. Synergies with the Recovery and Resilience Facility shall ensure that: (a) R&I needs to support making Member States economies and society more resilient and better prepared for the future are identified through the Programme's strategic planning; (b) the take-up and deployment of innovative solutions, in particular those resulting from the Programme, are supported. ANNEX V KEY IMPACT PATHWAY INDICATORS Impact pathways, and related key impact pathway indicators, shall structure the monitoring of the Programme's progress towards its objectives as referred to in Article 3. The impact pathways shall be time-sensitive and reflect three complementary impact categories reflecting the non-linear nature of R&I investments: scientific, societal and technological or economic. For each of those impact categories, proxy indicators are used to track progress distinguishing between the short, medium and longer terms, including beyond the Programme's duration, with possibilities for breakdowns, including by Member States and associated countries. Those indicators shall be compiled using quantitative and qualitative methodologies. Individual Programme parts contribute to those indicators to a different degree and through different mechanisms. Additional indicators can be used to monitor individual Programme parts, where relevant. The micro-data behind the key impact pathway indicators are collected for all parts of the Programme and for all delivery mechanisms in a centrally managed and harmonised way and at the appropriate level of granularity with minimal reporting burden on the beneficiaries. In addition and beyond key impact pathways indicators, data on the optimised delivery of the Programme for strengthening the ERA, fostering the excellence-based participations from all Member States in the Programme as well as facilitating collaborative links in European R&I are collected and reported in close to real-time as part of implementation and management data, referred to in Article 50. This includes the monitoring of collaborative links, of network analytics, of data on proposals, applications, participations, projects, applicants and participants (including data on the type of organisation, such as civil society organisations, SMEs and private sector), country (such as a specific classification for country groups such as Member States, associated countries and third countries), gender, role in project, scientific discipline or sector, including SSH), and the monitoring of the level of climate mainstreaming and related expenditures. Scientific impact pathway indicators The Programme is expected to have scientific impact by creating high-quality new knowledge, strengthening human capital in R&I, and fostering diffusion of knowledge and open science. Progress towards this impact is monitored through proxy indicators set along the following three key impact pathways. Table 1 Towards scientific impact Short-term Medium-term Longer-term Creating high-quality new knowledge Publications - Number of peer-reviewed scientific publications resulting from the Programme Citations - Field-Weighted Citation Index of peer-reviewed Publications resulting from the Programme World-class science - Number and share of peer-reviewed publications resulting from the projects funded by the Programme that are core contribution to scientific fields Strengthening human capital in R&I Skills - Number of researchers involved in upskilling (training, mentoring/coaching, mobility and access to R&I infrastructures) activities in projects funded by the Programme Careers - Number and share of upskilled researchers involved in the Programme with increased individual impact in their R&I field Working conditions - Number and share of upskilled researchers involved in the Programme with improved working conditions, including researchers' salaries Fostering diffusion of knowledge and open science Shared knowledge - Share of research outputs (open data/publication/software etc.) resulting from the Programme shared through open knowledge infrastructures Knowledge diffusion - Share of open access research outputs resulting from the Programme actively used/cited New collaborations - Share of Programme beneficiaries which have developed new transdisciplinary/transsectoral collaborations with users of their open access research outputs resulting from the Programme Societal impact pathway indicators The Programme is expected to have societal impact by addressing the Union's policy priorities and global challenges, including SDGs, following the principles of the 2030 Agenda and the goals of the Paris Agreement, through R&I, delivering benefits and impact through R&I missions and European Partnerships and strengthening the uptake of innovation in society ultimately contributing to people's well-being. Progress towards this impact is monitored through proxy indicators set along the following three key impact pathways. Table 2 Towards societal impact Short-term Medium-term Longer-term Addressing Union policy priorities and global challenges through R&I Results - Number and share of results aimed at addressing identified Union policy priorities and global challenges (including SDGs) (multidimensional: for each identified priority) Including: Number and share of climate-relevant results aimed at delivering on the Union's commitment under the Paris Agreement Solutions - Number and share of innovations and research outcomes addressing identified Union policy priorities and global challenges (including SDGs) (multidimensional: for each identified priority) Including: Number and share of climate-relevant innovations and research outcomes delivering on Union's commitment under the Paris Agreement Benefits - Aggregated estimated effects from use/exploitation of results funded by the Programme on tackling identified Union policy priorities and global challenges (including SDGs), including contribution to the policy and law-making cycle (such as norms and standards) (multidimensional: for each identified priority) Including: Aggregated estimated effects from use/exploitation of climate-relevant results funded by the Programme on delivering on the Union's commitment under the Paris Agreement including contribution to the policy and law-making cycle (such as norms and standards) Delivering benefits and impact through R&I missions R&I mission results - Results in specific R&I missions (multidimensional: for each identified mission) R&I mission outcomes - Outcomes in specific R&I missions (multidimensional: for each identified mission) R&I mission targets met - Targets achieved in specific R&I missions (multidimensional: for each identified mission) Strengthening the uptake of R&I in society Co-creation - Number and share of projects funded by the Programme where Union citizens and end-users contribute to the co-creation of R&I content Engagement - Number and share of participating legal entities which have citizen and end-users engagement mechanisms in place after the end of projects funded by the Programme Societal R&I uptake - Uptake and outreach of co-created scientific results and innovative solutions generated under the Programme Technological and Economic impact pathway indicators The Programme is expected to have technological and economic impact especially within the Union by influencing the creation and growth of companies, especially SMEs including start-ups, creating direct and indirect jobs especially within the Union, and by leveraging investments for R&I. Progress towards this impact is monitored through proxy indicators set along the following three key impact pathways. Table 3 Towards technological / economic impact Short-term Medium-term Longer-term Generating innovation-based growth Innovative results - Number of innovative products, processes or methods resulting from the Programme (by type of innovation) & Intellectual Property Rights (IPR) applications Innovations - Number of innovations resulting from the projects funded by the Programme (by type of innovation) including from awarded IPRs Economic growth - Creation, growth & market shares of companies having developed innovations in the Programme Creating more and better jobs Supported employment - Number of full time equivalent (FTE) jobs created, and jobs maintained in participating legal entities for the project funded by the Programme (by type of job) Sustained employment - Increase of FTE jobs in participating legal entities following the project funded by the Programme (by type of job) Total employment - Number of direct & indirect jobs created or maintained due to diffusion of results from the Programme (by type of job) Leveraging investments in R&I Co-investment - Amount of public & private investment mobilised with the initial investment from the Programme Scaling-up - Amount of public & private investment mobilised to exploit or scale-up results from the Programme (including foreign direct investments) Contribution to '3 % target' - Union progress towards 3 % GDP target due to the Programme ANNEX VI AREAS FOR POSSIBLE MISSIONS AND AREAS FOR POSSIBLE INSTITUTIONALISED EUROPEAN PARTNERSHIPS TO BE ESTABLISHED UNDER ARTICLE 185 OR 187 TFEU In accordance with Articles 8 and 12 of this Regulation, the areas for possible missions and possible European Partnerships to be established under Article 185 or 187 TFEU are set out in this Annex. I. Areas for possible missions: — Missions Area 1: Adaptation to Climate Change, including Societal Transformation. — Mission Area 2: Cancer. — Mission Area 3: Healthy Oceans, Seas, Coastal and Inland Waters. — Mission Area 4: Climate-Neutral and Smart Cities. — Mission Area 5: Soil Health and Food. Each mission follows the principles set out in Article 8(4) of this Regulation. II. Areas for possible Institutionalised European Partnerships on the basis of Article 185 or 187 TFEU: — Partnership Area 1: Faster development and safer use of health innovations for European patients, and global health. — Partnership Area 2: Advancing key digital and enabling technologies and their use, including but not limited to novel technologies such as artificial intelligence, photonics and quantum technologies. — Partnership Area 3: European leadership in Metrology including an integrated Metrology system. — Partnership Area 4: Accelerate competitiveness, safety and environmental performance of Union air traffic, aviation and rail. — Partnership Area 5: Sustainable, inclusive and circular bio-based solutions. — Partnership Area 6: Hydrogen and sustainable energy storage technologies with lower environmental footprint and less energy-intensive production. — Partnership Area 7: Clean, connected, cooperative, autonomous and automated solutions for future mobility demands of people and goods. — Partnership Area 8: Innovative and R&D intensive SMEs. The process of assessing the need for an Institutionalised European Partnership in one of the abovementioned Partnership Areas may result in a legislative proposal in accordance with the Commission's right of initiative. Otherwise the respective Partnership Area can also be subject to a European Partnership following point (a) of Article 10(1) or point (b) of Article 10(1) of this Regulation or be implemented by other calls for proposals within this Programme. As the possible areas for Institutionalised European Partnerships cover broad thematic fields, they can, based on the assessed needs, be implemented by more than one European Partnership.

Horizon Europe — the framework programme for research and innovation, laying down its rules for participation and dissemination Horizon Europe — the framework programme for research and innovation, laying down its rules for participation and dissemination SUMMARY OF: Regulation (EU) 2021/695 establishing Horizon Europe — the framework programme for research and innovation, laying down its rules for participation and dissemination WHAT IS THE AIM OF THE REGULATION? It establishes Horizon Europe — the framework programme for research and innovation (the ‘programme’) for the duration of the 2021-2027 multiannual financial framework , and lays down its rules for participation and dissemination.The regulation: determines the framework governing European Union (EU) support for research and innovation (R & I) in terms of the scientific and technological objectives to be achieved and the relevant priorities, indicates the broad lines of such activities and fixes the maximum overall amount and the detailed rules for EU financial participation in the framework programme and the respective shares in each of the activities provided for; sets out rules for the participation of undertakings, research centres and universities and lays down the rules governing the dissemination of research results. KEY POINTS Implementation The programme is implemented through: the specific programme established by Decision (EU) 2021/764 (see summary); a financial contribution to the European Institute of Innovation and Technology (EIT) established by Regulation (EU) 2021/819; the specific programme on defence research established by Regulation (EU) 2021/697 (see summary). Objectives The general objective of the programme is to deliver scientific, technological, economic and societal impact from the EU’s investments in R & I so as to: strengthen the EU’s scientific and technological bases and foster competitiveness in all EU Member States, including in its industry; deliver on the EU’s strategic priorities and contribute to the fulfilment of its objectives and policies; tackle global challenges, including meeting the UN sustainable development goals (SDGs) by following the principles of the 2030 Agenda and the Paris Agreement; strengthen the European research area (ERA). The programme thus maximises EU added value by focusing on objectives and activities that cannot be effectively fulfilled by Member States acting alone, but rather in cooperation. The programme has the following specific objectives: to develop, promote and advance scientific excellence, support the creation and diffusion of high-quality new fundamental and applied knowledge of skills, technologies and solutions, support training and mobility of researchers, attract talent at all levels and contribute to the full engagement of the EU’s talent pool in actions supported under the programme; to generate knowledge, strengthen the impact of R & I in developing, supporting and implementing EU policies and support access to and the uptake of innovative solutions in European industry, in particular in small and medium-sized enterprises, and address global societal challenges, including climate change and the sustainable development goals; to foster all forms of innovation, facilitate technological development, demonstration and knowledge and technology transfer, and strengthen the deployment and exploitation of innovative solutions; to optimise the programme’s delivery with a view to strengthening and increasing the impact and attractiveness of the European research area, foster excellence-based participation from all Member States, including low-R & I-performing countries, in the programme and facilitate collaborative links in European R & I. Structure and budget The programme is structured as follows, with a total budget of €95.5 billion at current prices (including €5.4 billion from NextGenerationEU). Pillar I — Excellent science With these components: European Research Council Marie Skłodowska-Curie actions research infrastructures. Pillar II — Global challenges and European industrial competitiveness With these components: ‘Health’ cluster; ‘Culture, creativity and inclusive society’ cluster; ‘Civil security for society’ cluster; ‘Digital, industry and space’ cluster; ‘Climate, energy and mobility’ cluster; ‘Food, bioeconomy, natural resources, agriculture and environment’ cluster; non-nuclear direct actions undertaken by the European Commission’s Joint Research Centre. Pillar III — Innovative Europe With these components: European Innovation Council (EIC) European innovation ecosystems (EIE) European Institute of Innovation and Technology (EIT). Part — Widening participation and strengthening the European research area With these components: widening participation and spreading excellence; reforming and enhancing the European R & I system. Missions Missions are portfolios of excellence-based and impact-driven R & I activities across disciplines and sectors, intended to: achieve, within a set time frame, a measurable goal that could not be achieved through individual actions; have an impact on society and policymaking through science and technology; be relevant for a significant part of the EU population and a wide range of EU citizens. Five areas for possible missions are identified in this legal act: adaptation to climate change, including societal transformation cancer healthy oceans, seas and coastal and inland waters climate-neutral and smart cities soil health and food. Each mission area has a dedicated mission board, which advises the Commission in specifying, designing and implementing specific missions. European partnerships A streamlined landscape of three forms of European partnerships (co-funded, co-programmed and institutionalised) has been created in which the EU, national authorities and the private sector commit to supporting research and innovation efforts. The European Innovation Council The EIC has been created as a centrally managed one-stop shop for implementing actions under Pillar III ‘Innovative Europe’ which relate to the EIC. The EIC’s focus is mainly on breakthrough and disruptive innovation, especially targeting market-creating innovation, while also supporting all types of innovation, including incremental innovation. Involvement of non-EU countries Horizon Europe is open to the participation of legal entities from anywhere in the world, under the conditions set out in the rules, and where applicable together with any additional condition at work programme / call level. Participation in the programme in the form of association of non-EU countries is open to: European Economic Area (EEA) and European Free Trade Association (EFTA) countries; acceding countries, candidate countries and potential candidates; European neighbourhood policy countries; non-EU countries with a good capacity in science, technology and innovation and commitment to a rules-based open market economy. Rules for participation The regulation sets out different rules, such as for eligibility for participation and funding, ethical rules and principles, and security that are applicable to indirect actions funded under the programme. Examples of these include: any legal entity may participate and receive funding if it meets the eligibility conditions under the Horizon Europe rules, together with any other additional conditions in the work programme / call; the content of calls for proposals must be included in the work programme; the Commission or the funding body may issue a joint call for proposals with non-EU countries, including their scientific and technological organisations or agencies, international organisations and non-profit legal entities; procurement procedures must comply with competition rules and the principles of transparency, non-discrimination, equal treatment, sound financial management and proportionality; rules regarding financial capacity checks; the process to evaluate proposals, including the selection and award criteria — proposals are evaluated by an independent expert committee, based on excellence, impact, quality and efficiency of implementation; applicants may request an evaluation review if they consider that the evaluation procedure has not been correctly applied; obligations with respect to exploiting and disseminating the results, including regarding open science. Programme evaluation, impact assessment and monitoring The Commission evaluates and monitors Horizon Europe to assess progress in achieving the programme’s objectives. The programme is complemented by the research and training programme of the European Atomic Energy Community for 2021-2025. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND The regulation repeals Regulation (EU) No 1291/2013 and Regulation (EU) No 1290/2013. See also: Horizon Europe (European Commission) Horizon Europe: The EU research & innovation programme 2021-2027 (European Commission) European research area (ERA) (European Commission) A new ERA for research and innovation (European Commission). MAIN DOCUMENT Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe — the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, pp. 1-68) RELATED DOCUMENTS Regulation (EU) 2021/819 of the European Parliament and of the Council of 20 May 2021 on the European Institute of Innovation and Technology (recast) (OJ L 189, 28.5.2021, pp. 61-90) Council Decision (EU) 2021/764 of 10 May 2021 establishing the Specific Programme implementing Horizon Europe — the Framework Programme for Research and Innovation, and repealing Decision 2013/743/EU (OJ L 167I, 12.5.2021, pp. 1-80) Regulation (EU) 2021/697 of the European Parliament and of the Council of 29 April 2021 establishing the European Defence Fund and repealing Regulation (EU) 2018/1092 (OJ L 170, 12.5.2021, pp. 149-177) Council Regulation (Euratom) 2021/765 of 10 May 2021 establishing the Research and Training Programme of the European Atomic Energy Community for the period 2021-2025 complementing Horizon Europe — the Framework Programme for Research and Innovation and repealing Regulation (Euratom) 2018/1563 (OJ L 167I, 12.5.2021, pp. 81-100) Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433I, 22.12.2020, pp. 23-27) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433I, 22.12.2020, pp. 11-22) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, pp. 1-222) last update 02.07.2021

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4.5.2016 EN Official Journal of the European Union L 119/1 REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 16 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) The protection of natural persons in relation to the processing of personal data is a fundamental right. Article 8(1) of the Charter of Fundamental Rights of the European Union (the ‘Charter’) and Article 16(1) of the Treaty on the Functioning of the European Union (TFEU) provide that everyone has the right to the protection of personal data concerning him or her. (2) The principles of, and rules on the protection of natural persons with regard to the processing of their personal data should, whatever their nationality or residence, respect their fundamental rights and freedoms, in particular their right to the protection of personal data. This Regulation is intended to contribute to the accomplishment of an area of freedom, security and justice and of an economic union, to economic and social progress, to the strengthening and the convergence of the economies within the internal market, and to the well-being of natural persons. (3) Directive 95/46/EC of the European Parliament and of the Council (4) seeks to harmonise the protection of fundamental rights and freedoms of natural persons in respect of processing activities and to ensure the free flow of personal data between Member States. (4) The processing of personal data should be designed to serve mankind. The right to the protection of personal data is not an absolute right; it must be considered in relation to its function in society and be balanced against other fundamental rights, in accordance with the principle of proportionality. This Regulation respects all fundamental rights and observes the freedoms and principles recognised in the Charter as enshrined in the Treaties, in particular the respect for private and family life, home and communications, the protection of personal data, freedom of thought, conscience and religion, freedom of expression and information, freedom to conduct a business, the right to an effective remedy and to a fair trial, and cultural, religious and linguistic diversity. (5) The economic and social integration resulting from the functioning of the internal market has led to a substantial increase in cross-border flows of personal data. The exchange of personal data between public and private actors, including natural persons, associations and undertakings across the Union has increased. National authorities in the Member States are being called upon by Union law to cooperate and exchange personal data so as to be able to perform their duties or carry out tasks on behalf of an authority in another Member State. (6) Rapid technological developments and globalisation have brought new challenges for the protection of personal data. The scale of the collection and sharing of personal data has increased significantly. Technology allows both private companies and public authorities to make use of personal data on an unprecedented scale in order to pursue their activities. Natural persons increasingly make personal information available publicly and globally. Technology has transformed both the economy and social life, and should further facilitate the free flow of personal data within the Union and the transfer to third countries and international organisations, while ensuring a high level of the protection of personal data. (7) Those developments require a strong and more coherent data protection framework in the Union, backed by strong enforcement, given the importance of creating the trust that will allow the digital economy to develop across the internal market. Natural persons should have control of their own personal data. Legal and practical certainty for natural persons, economic operators and public authorities should be enhanced. (8) Where this Regulation provides for specifications or restrictions of its rules by Member State law, Member States may, as far as necessary for coherence and for making the national provisions comprehensible to the persons to whom they apply, incorporate elements of this Regulation into their national law. (9) The objectives and principles of Directive 95/46/EC remain sound, but it has not prevented fragmentation in the implementation of data protection across the Union, legal uncertainty or a widespread public perception that there are significant risks to the protection of natural persons, in particular with regard to online activity. Differences in the level of protection of the rights and freedoms of natural persons, in particular the right to the protection of personal data, with regard to the processing of personal data in the Member States may prevent the free flow of personal data throughout the Union. Those differences may therefore constitute an obstacle to the pursuit of economic activities at the level of the Union, distort competition and impede authorities in the discharge of their responsibilities under Union law. Such a difference in levels of protection is due to the existence of differences in the implementation and application of Directive 95/46/EC. (10) In order to ensure a consistent and high level of protection of natural persons and to remove the obstacles to flows of personal data within the Union, the level of protection of the rights and freedoms of natural persons with regard to the processing of such data should be equivalent in all Member States. Consistent and homogenous application of the rules for the protection of the fundamental rights and freedoms of natural persons with regard to the processing of personal data should be ensured throughout the Union. Regarding the processing of personal data for compliance with a legal obligation, for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller, Member States should be allowed to maintain or introduce national provisions to further specify the application of the rules of this Regulation. In conjunction with the general and horizontal law on data protection implementing Directive 95/46/EC, Member States have several sector-specific laws in areas that need more specific provisions. This Regulation also provides a margin of manoeuvre for Member States to specify its rules, including for the processing of special categories of personal data (‘sensitive data’). To that extent, this Regulation does not exclude Member State law that sets out the circumstances for specific processing situations, including determining more precisely the conditions under which the processing of personal data is lawful. (11) Effective protection of personal data throughout the Union requires the strengthening and setting out in detail of the rights of data subjects and the obligations of those who process and determine the processing of personal data, as well as equivalent powers for monitoring and ensuring compliance with the rules for the protection of personal data and equivalent sanctions for infringements in the Member States. (12) Article 16(2) TFEU mandates the European Parliament and the Council to lay down the rules relating to the protection of natural persons with regard to the processing of personal data and the rules relating to the free movement of personal data. (13) In order to ensure a consistent level of protection for natural persons throughout the Union and to prevent divergences hampering the free movement of personal data within the internal market, a Regulation is necessary to provide legal certainty and transparency for economic operators, including micro, small and medium-sized enterprises, and to provide natural persons in all Member States with the same level of legally enforceable rights and obligations and responsibilities for controllers and processors, to ensure consistent monitoring of the processing of personal data, and equivalent sanctions in all Member States as well as effective cooperation between the supervisory authorities of different Member States. The proper functioning of the internal market requires that the free movement of personal data within the Union is not restricted or prohibited for reasons connected with the protection of natural persons with regard to the processing of personal data. To take account of the specific situation of micro, small and medium-sized enterprises, this Regulation includes a derogation for organisations with fewer than 250 employees with regard to record-keeping. In addition, the Union institutions and bodies, and Member States and their supervisory authorities, are encouraged to take account of the specific needs of micro, small and medium-sized enterprises in the application of this Regulation. The notion of micro, small and medium-sized enterprises should draw from Article 2 of the Annex to Commission Recommendation 2003/361/EC (5). (14) The protection afforded by this Regulation should apply to natural persons, whatever their nationality or place of residence, in relation to the processing of their personal data. This Regulation does not cover the processing of personal data which concerns legal persons and in particular undertakings established as legal persons, including the name and the form of the legal person and the contact details of the legal person. (15) In order to prevent creating a serious risk of circumvention, the protection of natural persons should be technologically neutral and should not depend on the techniques used. The protection of natural persons should apply to the processing of personal data by automated means, as well as to manual processing, if the personal data are contained or are intended to be contained in a filing system. Files or sets of files, as well as their cover pages, which are not structured according to specific criteria should not fall within the scope of this Regulation. (16) This Regulation does not apply to issues of protection of fundamental rights and freedoms or the free flow of personal data related to activities which fall outside the scope of Union law, such as activities concerning national security. This Regulation does not apply to the processing of personal data by the Member States when carrying out activities in relation to the common foreign and security policy of the Union. (17) Regulation (EC) No 45/2001 of the European Parliament and of the Council (6) applies to the processing of personal data by the Union institutions, bodies, offices and agencies. Regulation (EC) No 45/2001 and other Union legal acts applicable to such processing of personal data should be adapted to the principles and rules established in this Regulation and applied in the light of this Regulation. In order to provide a strong and coherent data protection framework in the Union, the necessary adaptations of Regulation (EC) No 45/2001 should follow after the adoption of this Regulation, in order to allow application at the same time as this Regulation. (18) This Regulation does not apply to the processing of personal data by a natural person in the course of a purely personal or household activity and thus with no connection to a professional or commercial activity. Personal or household activities could include correspondence and the holding of addresses, or social networking and online activity undertaken within the context of such activities. However, this Regulation applies to controllers or processors which provide the means for processing personal data for such personal or household activities. (19) The protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security and the free movement of such data, is the subject of a specific Union legal act. This Regulation should not, therefore, apply to processing activities for those purposes. However, personal data processed by public authorities under this Regulation should, when used for those purposes, be governed by a more specific Union legal act, namely Directive (EU) 2016/680 of the European Parliament and of the Council (7). Member States may entrust competent authorities within the meaning of Directive (EU) 2016/680 with tasks which are not necessarily carried out for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and prevention of threats to public security, so that the processing of personal data for those other purposes, in so far as it is within the scope of Union law, falls within the scope of this Regulation. With regard to the processing of personal data by those competent authorities for purposes falling within scope of this Regulation, Member States should be able to maintain or introduce more specific provisions to adapt the application of the rules of this Regulation. Such provisions may determine more precisely specific requirements for the processing of personal data by those competent authorities for those other purposes, taking into account the constitutional, organisational and administrative structure of the respective Member State. When the processing of personal data by private bodies falls within the scope of this Regulation, this Regulation should provide for the possibility for Member States under specific conditions to restrict by law certain obligations and rights when such a restriction constitutes a necessary and proportionate measure in a democratic society to safeguard specific important interests including public security and the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security. This is relevant for instance in the framework of anti-money laundering or the activities of forensic laboratories. (20) While this Regulation applies, inter alia, to the activities of courts and other judicial authorities, Union or Member State law could specify the processing operations and processing procedures in relation to the processing of personal data by courts and other judicial authorities. The competence of the supervisory authorities should not cover the processing of personal data when courts are acting in their judicial capacity, in order to safeguard the independence of the judiciary in the performance of its judicial tasks, including decision-making. It should be possible to entrust supervision of such data processing operations to specific bodies within the judicial system of the Member State, which should, in particular ensure compliance with the rules of this Regulation, enhance awareness among members of the judiciary of their obligations under this Regulation and handle complaints in relation to such data processing operations. (21) This Regulation is without prejudice to the application of Directive 2000/31/EC of the European Parliament and of the Council (8), in particular of the liability rules of intermediary service providers in Articles 12 to 15 of that Directive. That Directive seeks to contribute to the proper functioning of the internal market by ensuring the free movement of information society services between Member States. (22) Any processing of personal data in the context of the activities of an establishment of a controller or a processor in the Union should be carried out in accordance with this Regulation, regardless of whether the processing itself takes place within the Union. Establishment implies the effective and real exercise of activity through stable arrangements. The legal form of such arrangements, whether through a branch or a subsidiary with a legal personality, is not the determining factor in that respect. (23) In order to ensure that natural persons are not deprived of the protection to which they are entitled under this Regulation, the processing of personal data of data subjects who are in the Union by a controller or a processor not established in the Union should be subject to this Regulation where the processing activities are related to offering goods or services to such data subjects irrespective of whether connected to a payment. In order to determine whether such a controller or processor is offering goods or services to data subjects who are in the Union, it should be ascertained whether it is apparent that the controller or processor envisages offering services to data subjects in one or more Member States in the Union. Whereas the mere accessibility of the controller's, processor's or an intermediary's website in the Union, of an email address or of other contact details, or the use of a language generally used in the third country where the controller is established, is insufficient to ascertain such intention, factors such as the use of a language or a currency generally used in one or more Member States with the possibility of ordering goods and services in that other language, or the mentioning of customers or users who are in the Union, may make it apparent that the controller envisages offering goods or services to data subjects in the Union. (24) The processing of personal data of data subjects who are in the Union by a controller or processor not established in the Union should also be subject to this Regulation when it is related to the monitoring of the behaviour of such data subjects in so far as their behaviour takes place within the Union. In order to determine whether a processing activity can be considered to monitor the behaviour of data subjects, it should be ascertained whether natural persons are tracked on the internet including potential subsequent use of personal data processing techniques which consist of profiling a natural person, particularly in order to take decisions concerning her or him or for analysing or predicting her or his personal preferences, behaviours and attitudes. (25) Where Member State law applies by virtue of public international law, this Regulation should also apply to a controller not established in the Union, such as in a Member State's diplomatic mission or consular post. (26) The principles of data protection should apply to any information concerning an identified or identifiable natural person. Personal data which have undergone pseudonymisation, which could be attributed to a natural person by the use of additional information should be considered to be information on an identifiable natural person. To determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used, such as singling out, either by the controller or by another person to identify the natural person directly or indirectly. To ascertain whether means are reasonably likely to be used to identify the natural person, account should be taken of all objective factors, such as the costs of and the amount of time required for identification, taking into consideration the available technology at the time of the processing and technological developments. The principles of data protection should therefore not apply to anonymous information, namely information which does not relate to an identified or identifiable natural person or to personal data rendered anonymous in such a manner that the data subject is not or no longer identifiable. This Regulation does not therefore concern the processing of such anonymous information, including for statistical or research purposes. (27) This Regulation does not apply to the personal data of deceased persons. Member States may provide for rules regarding the processing of personal data of deceased persons. (28) The application of pseudonymisation to personal data can reduce the risks to the data subjects concerned and help controllers and processors to meet their data-protection obligations. The explicit introduction of ‘pseudonymisation’ in this Regulation is not intended to preclude any other measures of data protection. (29) In order to create incentives to apply pseudonymisation when processing personal data, measures of pseudonymisation should, whilst allowing general analysis, be possible within the same controller when that controller has taken technical and organisational measures necessary to ensure, for the processing concerned, that this Regulation is implemented, and that additional information for attributing the personal data to a specific data subject is kept separately. The controller processing the personal data should indicate the authorised persons within the same controller. (30) Natural persons may be associated with online identifiers provided by their devices, applications, tools and protocols, such as internet protocol addresses, cookie identifiers or other identifiers such as radio frequency identification tags. This may leave traces which, in particular when combined with unique identifiers and other information received by the servers, may be used to create profiles of the natural persons and identify them. (31) Public authorities to which personal data are disclosed in accordance with a legal obligation for the exercise of their official mission, such as tax and customs authorities, financial investigation units, independent administrative authorities, or financial market authorities responsible for the regulation and supervision of securities markets should not be regarded as recipients if they receive personal data which are necessary to carry out a particular inquiry in the general interest, in accordance with Union or Member State law. The requests for disclosure sent by the public authorities should always be in writing, reasoned and occasional and should not concern the entirety of a filing system or lead to the interconnection of filing systems. The processing of personal data by those public authorities should comply with the applicable data-protection rules according to the purposes of the processing. (32) Consent should be given by a clear affirmative act establishing a freely given, specific, informed and unambiguous indication of the data subject's agreement to the processing of personal data relating to him or her, such as by a written statement, including by electronic means, or an oral statement. This could include ticking a box when visiting an internet website, choosing technical settings for information society services or another statement or conduct which clearly indicates in this context the data subject's acceptance of the proposed processing of his or her personal data. Silence, pre-ticked boxes or inactivity should not therefore constitute consent. Consent should cover all processing activities carried out for the same purpose or purposes. When the processing has multiple purposes, consent should be given for all of them. If the data subject's consent is to be given following a request by electronic means, the request must be clear, concise and not unnecessarily disruptive to the use of the service for which it is provided. (33) It is often not possible to fully identify the purpose of personal data processing for scientific research purposes at the time of data collection. Therefore, data subjects should be allowed to give their consent to certain areas of scientific research when in keeping with recognised ethical standards for scientific research. Data subjects should have the opportunity to give their consent only to certain areas of research or parts of research projects to the extent allowed by the intended purpose. (34) Genetic data should be defined as personal data relating to the inherited or acquired genetic characteristics of a natural person which result from the analysis of a biological sample from the natural person in question, in particular chromosomal, deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) analysis, or from the analysis of another element enabling equivalent information to be obtained. (35) Personal data concerning health should include all data pertaining to the health status of a data subject which reveal information relating to the past, current or future physical or mental health status of the data subject. This includes information about the natural person collected in the course of the registration for, or the provision of, health care services as referred to in Directive 2011/24/EU of the European Parliament and of the Council (9) to that natural person; a number, symbol or particular assigned to a natural person to uniquely identify the natural person for health purposes; information derived from the testing or examination of a body part or bodily substance, including from genetic data and biological samples; and any information on, for example, a disease, disability, disease risk, medical history, clinical treatment or the physiological or biomedical state of the data subject independent of its source, for example from a physician or other health professional, a hospital, a medical device or an in vitro diagnostic test. (36) The main establishment of a controller in the Union should be the place of its central administration in the Union, unless the decisions on the purposes and means of the processing of personal data are taken in another establishment of the controller in the Union, in which case that other establishment should be considered to be the main establishment. The main establishment of a controller in the Union should be determined according to objective criteria and should imply the effective and real exercise of management activities determining the main decisions as to the purposes and means of processing through stable arrangements. That criterion should not depend on whether the processing of personal data is carried out at that location. The presence and use of technical means and technologies for processing personal data or processing activities do not, in themselves, constitute a main establishment and are therefore not determining criteria for a main establishment. The main establishment of the processor should be the place of its central administration in the Union or, if it has no central administration in the Union, the place where the main processing activities take place in the Union. In cases involving both the controller and the processor, the competent lead supervisory authority should remain the supervisory authority of the Member State where the controller has its main establishment, but the supervisory authority of the processor should be considered to be a supervisory authority concerned and that supervisory authority should participate in the cooperation procedure provided for by this Regulation. In any case, the supervisory authorities of the Member State or Member States where the processor has one or more establishments should not be considered to be supervisory authorities concerned where the draft decision concerns only the controller. Where the processing is carried out by a group of undertakings, the main establishment of the controlling undertaking should be considered to be the main establishment of the group of undertakings, except where the purposes and means of processing are determined by another undertaking. (37) A group of undertakings should cover a controlling undertaking and its controlled undertakings, whereby the controlling undertaking should be the undertaking which can exert a dominant influence over the other undertakings by virtue, for example, of ownership, financial participation or the rules which govern it or the power to have personal data protection rules implemented. An undertaking which controls the processing of personal data in undertakings affiliated to it should be regarded, together with those undertakings, as a group of undertakings. (38) Children merit specific protection with regard to their personal data, as they may be less aware of the risks, consequences and safeguards concerned and their rights in relation to the processing of personal data. Such specific protection should, in particular, apply to the use of personal data of children for the purposes of marketing or creating personality or user profiles and the collection of personal data with regard to children when using services offered directly to a child. The consent of the holder of parental responsibility should not be necessary in the context of preventive or counselling services offered directly to a child. (39) Any processing of personal data should be lawful and fair. It should be transparent to natural persons that personal data concerning them are collected, used, consulted or otherwise processed and to what extent the personal data are or will be processed. The principle of transparency requires that any information and communication relating to the processing of those personal data be easily accessible and easy to understand, and that clear and plain language be used. That principle concerns, in particular, information to the data subjects on the identity of the controller and the purposes of the processing and further information to ensure fair and transparent processing in respect of the natural persons concerned and their right to obtain confirmation and communication of personal data concerning them which are being processed. Natural persons should be made aware of risks, rules, safeguards and rights in relation to the processing of personal data and how to exercise their rights in relation to such processing. In particular, the specific purposes for which personal data are processed should be explicit and legitimate and determined at the time of the collection of the personal data. The personal data should be adequate, relevant and limited to what is necessary for the purposes for which they are processed. This requires, in particular, ensuring that the period for which the personal data are stored is limited to a strict minimum. Personal data should be processed only if the purpose of the processing could not reasonably be fulfilled by other means. In order to ensure that the personal data are not kept longer than necessary, time limits should be established by the controller for erasure or for a periodic review. Every reasonable step should be taken to ensure that personal data which are inaccurate are rectified or deleted. Personal data should be processed in a manner that ensures appropriate security and confidentiality of the personal data, including for preventing unauthorised access to or use of personal data and the equipment used for the processing. (40) In order for processing to be lawful, personal data should be processed on the basis of the consent of the data subject concerned or some other legitimate basis, laid down by law, either in this Regulation or in other Union or Member State law as referred to in this Regulation, including the necessity for compliance with the legal obligation to which the controller is subject or the necessity for the performance of a contract to which the data subject is party or in order to take steps at the request of the data subject prior to entering into a contract. (41) Where this Regulation refers to a legal basis or a legislative measure, this does not necessarily require a legislative act adopted by a parliament, without prejudice to requirements pursuant to the constitutional order of the Member State concerned. However, such a legal basis or legislative measure should be clear and precise and its application should be foreseeable to persons subject to it, in accordance with the case-law of the Court of Justice of the European Union (the ‘Court of Justice’) and the European Court of Human Rights. (42) Where processing is based on the data subject's consent, the controller should be able to demonstrate that the data subject has given consent to the processing operation. In particular in the context of a written declaration on another matter, safeguards should ensure that the data subject is aware of the fact that and the extent to which consent is given. In accordance with Council Directive 93/13/EEC (10) a declaration of consent pre-formulated by the controller should be provided in an intelligible and easily accessible form, using clear and plain language and it should not contain unfair terms. For consent to be informed, the data subject should be aware at least of the identity of the controller and the purposes of the processing for which the personal data are intended. Consent should not be regarded as freely given if the data subject has no genuine or free choice or is unable to refuse or withdraw consent without detriment. (43) In order to ensure that consent is freely given, consent should not provide a valid legal ground for the processing of personal data in a specific case where there is a clear imbalance between the data subject and the controller, in particular where the controller is a public authority and it is therefore unlikely that consent was freely given in all the circumstances of that specific situation. Consent is presumed not to be freely given if it does not allow separate consent to be given to different personal data processing operations despite it being appropriate in the individual case, or if the performance of a contract, including the provision of a service, is dependent on the consent despite such consent not being necessary for such performance. (44) Processing should be lawful where it is necessary in the context of a contract or the intention to enter into a contract. (45) Where processing is carried out in accordance with a legal obligation to which the controller is subject or where processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority, the processing should have a basis in Union or Member State law. This Regulation does not require a specific law for each individual processing. A law as a basis for several processing operations based on a legal obligation to which the controller is subject or where processing is necessary for the performance of a task carried out in the public interest or in the exercise of an official authority may be sufficient. It should also be for Union or Member State law to determine the purpose of processing. Furthermore, that law could specify the general conditions of this Regulation governing the lawfulness of personal data processing, establish specifications for determining the controller, the type of personal data which are subject to the processing, the data subjects concerned, the entities to which the personal data may be disclosed, the purpose limitations, the storage period and other measures to ensure lawful and fair processing. It should also be for Union or Member State law to determine whether the controller performing a task carried out in the public interest or in the exercise of official authority should be a public authority or another natural or legal person governed by public law, or, where it is in the public interest to do so, including for health purposes such as public health and social protection and the management of health care services, by private law, such as a professional association. (46) The processing of personal data should also be regarded to be lawful where it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. Processing of personal data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. Some types of processing may serve both important grounds of public interest and the vital interests of the data subject as for instance when processing is necessary for humanitarian purposes, including for monitoring epidemics and their spread or in situations of humanitarian emergencies, in particular in situations of natural and man-made disasters. (47) The legitimate interests of a controller, including those of a controller to which the personal data may be disclosed, or of a third party, may provide a legal basis for processing, provided that the interests or the fundamental rights and freedoms of the data subject are not overriding, taking into consideration the reasonable expectations of data subjects based on their relationship with the controller. Such legitimate interest could exist for example where there is a relevant and appropriate relationship between the data subject and the controller in situations such as where the data subject is a client or in the service of the controller. At any rate the existence of a legitimate interest would need careful assessment including whether a data subject can reasonably expect at the time and in the context of the collection of the personal data that processing for that purpose may take place. The interests and fundamental rights of the data subject could in particular override the interest of the data controller where personal data are processed in circumstances where data subjects do not reasonably expect further processing. Given that it is for the legislator to provide by law for the legal basis for public authorities to process personal data, that legal basis should not apply to the processing by public authorities in the performance of their tasks. The processing of personal data strictly necessary for the purposes of preventing fraud also constitutes a legitimate interest of the data controller concerned. The processing of personal data for direct marketing purposes may be regarded as carried out for a legitimate interest. (48) Controllers that are part of a group of undertakings or institutions affiliated to a central body may have a legitimate interest in transmitting personal data within the group of undertakings for internal administrative purposes, including the processing of clients' or employees' personal data. The general principles for the transfer of personal data, within a group of undertakings, to an undertaking located in a third country remain unaffected. (49) The processing of personal data to the extent strictly necessary and proportionate for the purposes of ensuring network and information security, i.e. the ability of a network or an information system to resist, at a given level of confidence, accidental events or unlawful or malicious actions that compromise the availability, authenticity, integrity and confidentiality of stored or transmitted personal data, and the security of the related services offered by, or accessible via, those networks and systems, by public authorities, by computer emergency response teams (CERTs), computer security incident response teams (CSIRTs), by providers of electronic communications networks and services and by providers of security technologies and services, constitutes a legitimate interest of the data controller concerned. This could, for example, include preventing unauthorised access to electronic communications networks and malicious code distribution and stopping ‘denial of service’ attacks and damage to computer and electronic communication systems. (50) The processing of personal data for purposes other than those for which the personal data were initially collected should be allowed only where the processing is compatible with the purposes for which the personal data were initially collected. In such a case, no legal basis separate from that which allowed the collection of the personal data is required. If the processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller, Union or Member State law may determine and specify the tasks and purposes for which the further processing should be regarded as compatible and lawful. Further processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes should be considered to be compatible lawful processing operations. The legal basis provided by Union or Member State law for the processing of personal data may also provide a legal basis for further processing. In order to ascertain whether a purpose of further processing is compatible with the purpose for which the personal data are initially collected, the controller, after having met all the requirements for the lawfulness of the original processing, should take into account, inter alia: any link between those purposes and the purposes of the intended further processing; the context in which the personal data have been collected, in particular the reasonable expectations of data subjects based on their relationship with the controller as to their further use; the nature of the personal data; the consequences of the intended further processing for data subjects; and the existence of appropriate safeguards in both the original and intended further processing operations. Where the data subject has given consent or the processing is based on Union or Member State law which constitutes a necessary and proportionate measure in a democratic society to safeguard, in particular, important objectives of general public interest, the controller should be allowed to further process the personal data irrespective of the compatibility of the purposes. In any case, the application of the principles set out in this Regulation and in particular the information of the data subject on those other purposes and on his or her rights including the right to object, should be ensured. Indicating possible criminal acts or threats to public security by the controller and transmitting the relevant personal data in individual cases or in several cases relating to the same criminal act or threats to public security to a competent authority should be regarded as being in the legitimate interest pursued by the controller. However, such transmission in the legitimate interest of the controller or further processing of personal data should be prohibited if the processing is not compatible with a legal, professional or other binding obligation of secrecy. (51) Personal data which are, by their nature, particularly sensitive in relation to fundamental rights and freedoms merit specific protection as the context of their processing could create significant risks to the fundamental rights and freedoms. Those personal data should include personal data revealing racial or ethnic origin, whereby the use of the term ‘racial origin’ in this Regulation does not imply an acceptance by the Union of theories which attempt to determine the existence of separate human races. The processing of photographs should not systematically be considered to be processing of special categories of personal data as they are covered by the definition of biometric data only when processed through a specific technical means allowing the unique identification or authentication of a natural person. Such personal data should not be processed, unless processing is allowed in specific cases set out in this Regulation, taking into account that Member States law may lay down specific provisions on data protection in order to adapt the application of the rules of this Regulation for compliance with a legal obligation or for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. In addition to the specific requirements for such processing, the general principles and other rules of this Regulation should apply, in particular as regards the conditions for lawful processing. Derogations from the general prohibition for processing such special categories of personal data should be explicitly provided, inter alia, where the data subject gives his or her explicit consent or in respect of specific needs in particular where the processing is carried out in the course of legitimate activities by certain associations or foundations the purpose of which is to permit the exercise of fundamental freedoms. (52) Derogating from the prohibition on processing special categories of personal data should also be allowed when provided for in Union or Member State law and subject to suitable safeguards, so as to protect personal data and other fundamental rights, where it is in the public interest to do so, in particular processing personal data in the field of employment law, social protection law including pensions and for health security, monitoring and alert purposes, the prevention or control of communicable diseases and other serious threats to health. Such a derogation may be made for health purposes, including public health and the management of health-care services, especially in order to ensure the quality and cost-effectiveness of the procedures used for settling claims for benefits and services in the health insurance system, or for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. A derogation should also allow the processing of such personal data where necessary for the establishment, exercise or defence of legal claims, whether in court proceedings or in an administrative or out-of-court procedure. (53) Special categories of personal data which merit higher protection should be processed for health-related purposes only where necessary to achieve those purposes for the benefit of natural persons and society as a whole, in particular in the context of the management of health or social care services and systems, including processing by the management and central national health authorities of such data for the purpose of quality control, management information and the general national and local supervision of the health or social care system, and ensuring continuity of health or social care and cross-border healthcare or health security, monitoring and alert purposes, or for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, based on Union or Member State law which has to meet an objective of public interest, as well as for studies conducted in the public interest in the area of public health. Therefore, this Regulation should provide for harmonised conditions for the processing of special categories of personal data concerning health, in respect of specific needs, in particular where the processing of such data is carried out for certain health-related purposes by persons subject to a legal obligation of professional secrecy. Union or Member State law should provide for specific and suitable measures so as to protect the fundamental rights and the personal data of natural persons. Member States should be allowed to maintain or introduce further conditions, including limitations, with regard to the processing of genetic data, biometric data or data concerning health. However, this should not hamper the free flow of personal data within the Union when those conditions apply to cross-border processing of such data. (54) The processing of special categories of personal data may be necessary for reasons of public interest in the areas of public health without consent of the data subject. Such processing should be subject to suitable and specific measures so as to protect the rights and freedoms of natural persons. In that context, ‘public health’ should be interpreted as defined in Regulation (EC) No 1338/2008 of the European Parliament and of the Council (11), namely all elements related to health, namely health status, including morbidity and disability, the determinants having an effect on that health status, health care needs, resources allocated to health care, the provision of, and universal access to, health care as well as health care expenditure and financing, and the causes of mortality. Such processing of data concerning health for reasons of public interest should not result in personal data being processed for other purposes by third parties such as employers or insurance and banking companies. (55) Moreover, the processing of personal data by official authorities for the purpose of achieving the aims, laid down by constitutional law or by international public law, of officially recognised religious associations, is carried out on grounds of public interest. (56) Where in the course of electoral activities, the operation of the democratic system in a Member State requires that political parties compile personal data on people's political opinions, the processing of such data may be permitted for reasons of public interest, provided that appropriate safeguards are established. (57) If the personal data processed by a controller do not permit the controller to identify a natural person, the data controller should not be obliged to acquire additional information in order to identify the data subject for the sole purpose of complying with any provision of this Regulation. However, the controller should not refuse to take additional information provided by the data subject in order to support the exercise of his or her rights. Identification should include the digital identification of a data subject, for example through authentication mechanism such as the same credentials, used by the data subject to log-in to the on-line service offered by the data controller. (58) The principle of transparency requires that any information addressed to the public or to the data subject be concise, easily accessible and easy to understand, and that clear and plain language and, additionally, where appropriate, visualisation be used. Such information could be provided in electronic form, for example, when addressed to the public, through a website. This is of particular relevance in situations where the proliferation of actors and the technological complexity of practice make it difficult for the data subject to know and understand whether, by whom and for what purpose personal data relating to him or her are being collected, such as in the case of online advertising. Given that children merit specific protection, any information and communication, where processing is addressed to a child, should be in such a clear and plain language that the child can easily understand. (59) Modalities should be provided for facilitating the exercise of the data subject's rights under this Regulation, including mechanisms to request and, if applicable, obtain, free of charge, in particular, access to and rectification or erasure of personal data and the exercise of the right to object. The controller should also provide means for requests to be made electronically, especially where personal data are processed by electronic means. The controller should be obliged to respond to requests from the data subject without undue delay and at the latest within one month and to give reasons where the controller does not intend to comply with any such requests. (60) The principles of fair and transparent processing require that the data subject be informed of the existence of the processing operation and its purposes. The controller should provide the data subject with any further information necessary to ensure fair and transparent processing taking into account the specific circumstances and context in which the personal data are processed. Furthermore, the data subject should be informed of the existence of profiling and the consequences of such profiling. Where the personal data are collected from the data subject, the data subject should also be informed whether he or she is obliged to provide the personal data and of the consequences, where he or she does not provide such data. That information may be provided in combination with standardised icons in order to give in an easily visible, intelligible and clearly legible manner, a meaningful overview of the intended processing. Where the icons are presented electronically, they should be machine-readable. (61) The information in relation to the processing of personal data relating to the data subject should be given to him or her at the time of collection from the data subject, or, where the personal data are obtained from another source, within a reasonable period, depending on the circumstances of the case. Where personal data can be legitimately disclosed to another recipient, the data subject should be informed when the personal data are first disclosed to the recipient. Where the controller intends to process the personal data for a purpose other than that for which they were collected, the controller should provide the data subject prior to that further processing with information on that other purpose and other necessary information. Where the origin of the personal data cannot be provided to the data subject because various sources have been used, general information should be provided. (62) However, it is not necessary to impose the obligation to provide information where the data subject already possesses the information, where the recording or disclosure of the personal data is expressly laid down by law or where the provision of information to the data subject proves to be impossible or would involve a disproportionate effort. The latter could in particular be the case where processing is carried out for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. In that regard, the number of data subjects, the age of the data and any appropriate safeguards adopted should be taken into consideration. (63) A data subject should have the right of access to personal data which have been collected concerning him or her, and to exercise that right easily and at reasonable intervals, in order to be aware of, and verify, the lawfulness of the processing. This includes the right for data subjects to have access to data concerning their health, for example the data in their medical records containing information such as diagnoses, examination results, assessments by treating physicians and any treatment or interventions provided. Every data subject should therefore have the right to know and obtain communication in particular with regard to the purposes for which the personal data are processed, where possible the period for which the personal data are processed, the recipients of the personal data, the logic involved in any automatic personal data processing and, at least when based on profiling, the consequences of such processing. Where possible, the controller should be able to provide remote access to a secure system which would provide the data subject with direct access to his or her personal data. That right should not adversely affect the rights or freedoms of others, including trade secrets or intellectual property and in particular the copyright protecting the software. However, the result of those considerations should not be a refusal to provide all information to the data subject. Where the controller processes a large quantity of information concerning the data subject, the controller should be able to request that, before the information is delivered, the data subject specify the information or processing activities to which the request relates. (64) The controller should use all reasonable measures to verify the identity of a data subject who requests access, in particular in the context of online services and online identifiers. A controller should not retain personal data for the sole purpose of being able to react to potential requests. (65) A data subject should have the right to have personal data concerning him or her rectified and a ‘right to be forgotten’ where the retention of such data infringes this Regulation or Union or Member State law to which the controller is subject. In particular, a data subject should have the right to have his or her personal data erased and no longer processed where the personal data are no longer necessary in relation to the purposes for which they are collected or otherwise processed, where a data subject has withdrawn his or her consent or objects to the processing of personal data concerning him or her, or where the processing of his or her personal data does not otherwise comply with this Regulation. That right is relevant in particular where the data subject has given his or her consent as a child and is not fully aware of the risks involved by the processing, and later wants to remove such personal data, especially on the internet. The data subject should be able to exercise that right notwithstanding the fact that he or she is no longer a child. However, the further retention of the personal data should be lawful where it is necessary, for exercising the right of freedom of expression and information, for compliance with a legal obligation, for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller, on the grounds of public interest in the area of public health, for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, or for the establishment, exercise or defence of legal claims. (66) To strengthen the right to be forgotten in the online environment, the right to erasure should also be extended in such a way that a controller who has made the personal data public should be obliged to inform the controllers which are processing such personal data to erase any links to, or copies or replications of those personal data. In doing so, that controller should take reasonable steps, taking into account available technology and the means available to the controller, including technical measures, to inform the controllers which are processing the personal data of the data subject's request. (67) Methods by which to restrict the processing of personal data could include, inter alia, temporarily moving the selected data to another processing system, making the selected personal data unavailable to users, or temporarily removing published data from a website. In automated filing systems, the restriction of processing should in principle be ensured by technical means in such a manner that the personal data are not subject to further processing operations and cannot be changed. The fact that the processing of personal data is restricted should be clearly indicated in the system. (68) To further strengthen the control over his or her own data, where the processing of personal data is carried out by automated means, the data subject should also be allowed to receive personal data concerning him or her which he or she has provided to a controller in a structured, commonly used, machine-readable and interoperable format, and to transmit it to another controller. Data controllers should be encouraged to develop interoperable formats that enable data portability. That right should apply where the data subject provided the personal data on the basis of his or her consent or the processing is necessary for the performance of a contract. It should not apply where processing is based on a legal ground other than consent or contract. By its very nature, that right should not be exercised against controllers processing personal data in the exercise of their public duties. It should therefore not apply where the processing of the personal data is necessary for compliance with a legal obligation to which the controller is subject or for the performance of a task carried out in the public interest or in the exercise of an official authority vested in the controller. The data subject's right to transmit or receive personal data concerning him or her should not create an obligation for the controllers to adopt or maintain processing systems which are technically compatible. Where, in a certain set of personal data, more than one data subject is concerned, the right to receive the personal data should be without prejudice to the rights and freedoms of other data subjects in accordance with this Regulation. Furthermore, that right should not prejudice the right of the data subject to obtain the erasure of personal data and the limitations of that right as set out in this Regulation and should, in particular, not imply the erasure of personal data concerning the data subject which have been provided by him or her for the performance of a contract to the extent that and for as long as the personal data are necessary for the performance of that contract. Where technically feasible, the data subject should have the right to have the personal data transmitted directly from one controller to another. (69) Where personal data might lawfully be processed because processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller, or on grounds of the legitimate interests of a controller or a third party, a data subject should, nevertheless, be entitled to object to the processing of any personal data relating to his or her particular situation. It should be for the controller to demonstrate that its compelling legitimate interest overrides the interests or the fundamental rights and freedoms of the data subject. (70) Where personal data are processed for the purposes of direct marketing, the data subject should have the right to object to such processing, including profiling to the extent that it is related to such direct marketing, whether with regard to initial or further processing, at any time and free of charge. That right should be explicitly brought to the attention of the data subject and presented clearly and separately from any other information. (71) The data subject should have the right not to be subject to a decision, which may include a measure, evaluating personal aspects relating to him or her which is based solely on automated processing and which produces legal effects concerning him or her or similarly significantly affects him or her, such as automatic refusal of an online credit application or e-recruiting practices without any human intervention. Such processing includes ‘profiling’ that consists of any form of automated processing of personal data evaluating the personal aspects relating to a natural person, in particular to analyse or predict aspects concerning the data subject's performance at work, economic situation, health, personal preferences or interests, reliability or behaviour, location or movements, where it produces legal effects concerning him or her or similarly significantly affects him or her. However, decision-making based on such processing, including profiling, should be allowed where expressly authorised by Union or Member State law to which the controller is subject, including for fraud and tax-evasion monitoring and prevention purposes conducted in accordance with the regulations, standards and recommendations of Union institutions or national oversight bodies and to ensure the security and reliability of a service provided by the controller, or necessary for the entering or performance of a contract between the data subject and a controller, or when the data subject has given his or her explicit consent. In any case, such processing should be subject to suitable safeguards, which should include specific information to the data subject and the right to obtain human intervention, to express his or her point of view, to obtain an explanation of the decision reached after such assessment and to challenge the decision. Such measure should not concern a child. In order to ensure fair and transparent processing in respect of the data subject, taking into account the specific circumstances and context in which the personal data are processed, the controller should use appropriate mathematical or statistical procedures for the profiling, implement technical and organisational measures appropriate to ensure, in particular, that factors which result in inaccuracies in personal data are corrected and the risk of errors is minimised, secure personal data in a manner that takes account of the potential risks involved for the interests and rights of the data subject and that prevents, inter alia, discriminatory effects on natural persons on the basis of racial or ethnic origin, political opinion, religion or beliefs, trade union membership, genetic or health status or sexual orientation, or that result in measures having such an effect. Automated decision-making and profiling based on special categories of personal data should be allowed only under specific conditions. (72) Profiling is subject to the rules of this Regulation governing the processing of personal data, such as the legal grounds for processing or data protection principles. The European Data Protection Board established by this Regulation (the ‘Board’) should be able to issue guidance in that context. (73) Restrictions concerning specific principles and the rights of information, access to and rectification or erasure of personal data, the right to data portability, the right to object, decisions based on profiling, as well as the communication of a personal data breach to a data subject and certain related obligations of the controllers may be imposed by Union or Member State law, as far as necessary and proportionate in a democratic society to safeguard public security, including the protection of human life especially in response to natural or manmade disasters, the prevention, investigation and prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security, or of breaches of ethics for regulated professions, other important objectives of general public interest of the Union or of a Member State, in particular an important economic or financial interest of the Union or of a Member State, the keeping of public registers kept for reasons of general public interest, further processing of archived personal data to provide specific information related to the political behaviour under former totalitarian state regimes or the protection of the data subject or the rights and freedoms of others, including social protection, public health and humanitarian purposes. Those restrictions should be in accordance with the requirements set out in the Charter and in the European Convention for the Protection of Human Rights and Fundamental Freedoms. (74) The responsibility and liability of the controller for any processing of personal data carried out by the controller or on the controller's behalf should be established. In particular, the controller should be obliged to implement appropriate and effective measures and be able to demonstrate the compliance of processing activities with this Regulation, including the effectiveness of the measures. Those measures should take into account the nature, scope, context and purposes of the processing and the risk to the rights and freedoms of natural persons. (75) The risk to the rights and freedoms of natural persons, of varying likelihood and severity, may result from personal data processing which could lead to physical, material or non-material damage, in particular: where the processing may give rise to discrimination, identity theft or fraud, financial loss, damage to the reputation, loss of confidentiality of personal data protected by professional secrecy, unauthorised reversal of pseudonymisation, or any other significant economic or social disadvantage; where data subjects might be deprived of their rights and freedoms or prevented from exercising control over their personal data; where personal data are processed which reveal racial or ethnic origin, political opinions, religion or philosophical beliefs, trade union membership, and the processing of genetic data, data concerning health or data concerning sex life or criminal convictions and offences or related security measures; where personal aspects are evaluated, in particular analysing or predicting aspects concerning performance at work, economic situation, health, personal preferences or interests, reliability or behaviour, location or movements, in order to create or use personal profiles; where personal data of vulnerable natural persons, in particular of children, are processed; or where processing involves a large amount of personal data and affects a large number of data subjects. (76) The likelihood and severity of the risk to the rights and freedoms of the data subject should be determined by reference to the nature, scope, context and purposes of the processing. Risk should be evaluated on the basis of an objective assessment, by which it is established whether data processing operations involve a risk or a high risk. (77) Guidance on the implementation of appropriate measures and on the demonstration of compliance by the controller or the processor, especially as regards the identification of the risk related to the processing, their assessment in terms of origin, nature, likelihood and severity, and the identification of best practices to mitigate the risk, could be provided in particular by means of approved codes of conduct, approved certifications, guidelines provided by the Board or indications provided by a data protection officer. The Board may also issue guidelines on processing operations that are considered to be unlikely to result in a high risk to the rights and freedoms of natural persons and indicate what measures may be sufficient in such cases to address such risk. (78) The protection of the rights and freedoms of natural persons with regard to the processing of personal data require that appropriate technical and organisational measures be taken to ensure that the requirements of this Regulation are met. In order to be able to demonstrate compliance with this Regulation, the controller should adopt internal policies and implement measures which meet in particular the principles of data protection by design and data protection by default. Such measures could consist, inter alia, of minimising the processing of personal data, pseudonymising personal data as soon as possible, transparency with regard to the functions and processing of personal data, enabling the data subject to monitor the data processing, enabling the controller to create and improve security features. When developing, designing, selecting and using applications, services and products that are based on the processing of personal data or process personal data to fulfil their task, producers of the products, services and applications should be encouraged to take into account the right to data protection when developing and designing such products, services and applications and, with due regard to the state of the art, to make sure that controllers and processors are able to fulfil their data protection obligations. The principles of data protection by design and by default should also be taken into consideration in the context of public tenders. (79) The protection of the rights and freedoms of data subjects as well as the responsibility and liability of controllers and processors, also in relation to the monitoring by and measures of supervisory authorities, requires a clear allocation of the responsibilities under this Regulation, including where a controller determines the purposes and means of the processing jointly with other controllers or where a processing operation is carried out on behalf of a controller. (80) Where a controller or a processor not established in the Union is processing personal data of data subjects who are in the Union whose processing activities are related to the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data subjects in the Union, or to the monitoring of their behaviour as far as their behaviour takes place within the Union, the controller or the processor should designate a representative, unless the processing is occasional, does not include processing, on a large scale, of special categories of personal data or the processing of personal data relating to criminal convictions and offences, and is unlikely to result in a risk to the rights and freedoms of natural persons, taking into account the nature, context, scope and purposes of the processing or if the controller is a public authority or body. The representative should act on behalf of the controller or the processor and may be addressed by any supervisory authority. The representative should be explicitly designated by a written mandate of the controller or of the processor to act on its behalf with regard to its obligations under this Regulation. The designation of such a representative does not affect the responsibility or liability of the controller or of the processor under this Regulation. Such a representative should perform its tasks according to the mandate received from the controller or processor, including cooperating with the competent supervisory authorities with regard to any action taken to ensure compliance with this Regulation. The designated representative should be subject to enforcement proceedings in the event of non-compliance by the controller or processor. (81) To ensure compliance with the requirements of this Regulation in respect of the processing to be carried out by the processor on behalf of the controller, when entrusting a processor with processing activities, the controller should use only processors providing sufficient guarantees, in particular in terms of expert knowledge, reliability and resources, to implement technical and organisational measures which will meet the requirements of this Regulation, including for the security of processing. The adherence of the processor to an approved code of conduct or an approved certification mechanism may be used as an element to demonstrate compliance with the obligations of the controller. The carrying-out of processing by a processor should be governed by a contract or other legal act under Union or Member State law, binding the processor to the controller, setting out the subject-matter and duration of the processing, the nature and purposes of the processing, the type of personal data and categories of data subjects, taking into account the specific tasks and responsibilities of the processor in the context of the processing to be carried out and the risk to the rights and freedoms of the data subject. The controller and processor may choose to use an individual contract or standard contractual clauses which are adopted either directly by the Commission or by a supervisory authority in accordance with the consistency mechanism and then adopted by the Commission. After the completion of the processing on behalf of the controller, the processor should, at the choice of the controller, return or delete the personal data, unless there is a requirement to store the personal data under Union or Member State law to which the processor is subject. (82) In order to demonstrate compliance with this Regulation, the controller or processor should maintain records of processing activities under its responsibility. Each controller and processor should be obliged to cooperate with the supervisory authority and make those records, on request, available to it, so that it might serve for monitoring those processing operations. (83) In order to maintain security and to prevent processing in infringement of this Regulation, the controller or processor should evaluate the risks inherent in the processing and implement measures to mitigate those risks, such as encryption. Those measures should ensure an appropriate level of security, including confidentiality, taking into account the state of the art and the costs of implementation in relation to the risks and the nature of the personal data to be protected. In assessing data security risk, consideration should be given to the risks that are presented by personal data processing, such as accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed which may in particular lead to physical, material or non-material damage. (84) In order to enhance compliance with this Regulation where processing operations are likely to result in a high risk to the rights and freedoms of natural persons, the controller should be responsible for the carrying-out of a data protection impact assessment to evaluate, in particular, the origin, nature, particularity and severity of that risk. The outcome of the assessment should be taken into account when determining the appropriate measures to be taken in order to demonstrate that the processing of personal data complies with this Regulation. Where a data-protection impact assessment indicates that processing operations involve a high risk which the controller cannot mitigate by appropriate measures in terms of available technology and costs of implementation, a consultation of the supervisory authority should take place prior to the processing. (85) A personal data breach may, if not addressed in an appropriate and timely manner, result in physical, material or non-material damage to natural persons such as loss of control over their personal data or limitation of their rights, discrimination, identity theft or fraud, financial loss, unauthorised reversal of pseudonymisation, damage to reputation, loss of confidentiality of personal data protected by professional secrecy or any other significant economic or social disadvantage to the natural person concerned. Therefore, as soon as the controller becomes aware that a personal data breach has occurred, the controller should notify the personal data breach to the supervisory authority without undue delay and, where feasible, not later than 72 hours after having become aware of it, unless the controller is able to demonstrate, in accordance with the accountability principle, that the personal data breach is unlikely to result in a risk to the rights and freedoms of natural persons. Where such notification cannot be achieved within 72 hours, the reasons for the delay should accompany the notification and information may be provided in phases without undue further delay. (86) The controller should communicate to the data subject a personal data breach, without undue delay, where that personal data breach is likely to result in a high risk to the rights and freedoms of the natural person in order to allow him or her to take the necessary precautions. The communication should describe the nature of the personal data breach as well as recommendations for the natural person concerned to mitigate potential adverse effects. Such communications to data subjects should be made as soon as reasonably feasible and in close cooperation with the supervisory authority, respecting guidance provided by it or by other relevant authorities such as law-enforcement authorities. For example, the need to mitigate an immediate risk of damage would call for prompt communication with data subjects whereas the need to implement appropriate measures against continuing or similar personal data breaches may justify more time for communication. (87) It should be ascertained whether all appropriate technological protection and organisational measures have been implemented to establish immediately whether a personal data breach has taken place and to inform promptly the supervisory authority and the data subject. The fact that the notification was made without undue delay should be established taking into account in particular the nature and gravity of the personal data breach and its consequences and adverse effects for the data subject. Such notification may result in an intervention of the supervisory authority in accordance with its tasks and powers laid down in this Regulation. (88) In setting detailed rules concerning the format and procedures applicable to the notification of personal data breaches, due consideration should be given to the circumstances of that breach, including whether or not personal data had been protected by appropriate technical protection measures, effectively limiting the likelihood of identity fraud or other forms of misuse. Moreover, such rules and procedures should take into account the legitimate interests of law-enforcement authorities where early disclosure could unnecessarily hamper the investigation of the circumstances of a personal data breach. (89) Directive 95/46/EC provided for a general obligation to notify the processing of personal data to the supervisory authorities. While that obligation produces administrative and financial burdens, it did not in all cases contribute to improving the protection of personal data. Such indiscriminate general notification obligations should therefore be abolished, and replaced by effective procedures and mechanisms which focus instead on those types of processing operations which are likely to result in a high risk to the rights and freedoms of natural persons by virtue of their nature, scope, context and purposes. Such types of processing operations may be those which in, particular, involve using new technologies, or are of a new kind and where no data protection impact assessment has been carried out before by the controller, or where they become necessary in the light of the time that has elapsed since the initial processing. (90) In such cases, a data protection impact assessment should be carried out by the controller prior to the processing in order to assess the particular likelihood and severity of the high risk, taking into account the nature, scope, context and purposes of the processing and the sources of the risk. That impact assessment should include, in particular, the measures, safeguards and mechanisms envisaged for mitigating that risk, ensuring the protection of personal data and demonstrating compliance with this Regulation. (91) This should in particular apply to large-scale processing operations which aim to process a considerable amount of personal data at regional, national or supranational level and which could affect a large number of data subjects and which are likely to result in a high risk, for example, on account of their sensitivity, where in accordance with the achieved state of technological knowledge a new technology is used on a large scale as well as to other processing operations which result in a high risk to the rights and freedoms of data subjects, in particular where those operations render it more difficult for data subjects to exercise their rights. A data protection impact assessment should also be made where personal data are processed for taking decisions regarding specific natural persons following any systematic and extensive evaluation of personal aspects relating to natural persons based on profiling those data or following the processing of special categories of personal data, biometric data, or data on criminal convictions and offences or related security measures. A data protection impact assessment is equally required for monitoring publicly accessible areas on a large scale, especially when using optic-electronic devices or for any other operations where the competent supervisory authority considers that the processing is likely to result in a high risk to the rights and freedoms of data subjects, in particular because they prevent data subjects from exercising a right or using a service or a contract, or because they are carried out systematically on a large scale. The processing of personal data should not be considered to be on a large scale if the processing concerns personal data from patients or clients by an individual physician, other health care professional or lawyer. In such cases, a data protection impact assessment should not be mandatory. (92) There are circumstances under which it may be reasonable and economical for the subject of a data protection impact assessment to be broader than a single project, for example where public authorities or bodies intend to establish a common application or processing platform or where several controllers plan to introduce a common application or processing environment across an industry sector or segment or for a widely used horizontal activity. (93) In the context of the adoption of the Member State law on which the performance of the tasks of the public authority or public body is based and which regulates the specific processing operation or set of operations in question, Member States may deem it necessary to carry out such assessment prior to the processing activities. (94) Where a data protection impact assessment indicates that the processing would, in the absence of safeguards, security measures and mechanisms to mitigate the risk, result in a high risk to the rights and freedoms of natural persons and the controller is of the opinion that the risk cannot be mitigated by reasonable means in terms of available technologies and costs of implementation, the supervisory authority should be consulted prior to the start of processing activities. Such high risk is likely to result from certain types of processing and the extent and frequency of processing, which may result also in a realisation of damage or interference with the rights and freedoms of the natural person. The supervisory authority should respond to the request for consultation within a specified period. However, the absence of a reaction of the supervisory authority within that period should be without prejudice to any intervention of the supervisory authority in accordance with its tasks and powers laid down in this Regulation, including the power to prohibit processing operations. As part of that consultation process, the outcome of a data protection impact assessment carried out with regard to the processing at issue may be submitted to the supervisory authority, in particular the measures envisaged to mitigate the risk to the rights and freedoms of natural persons. (95) The processor should assist the controller, where necessary and upon request, in ensuring compliance with the obligations deriving from the carrying out of data protection impact assessments and from prior consultation of the supervisory authority. (96) A consultation of the supervisory authority should also take place in the course of the preparation of a legislative or regulatory measure which provides for the processing of personal data, in order to ensure compliance of the intended processing with this Regulation and in particular to mitigate the risk involved for the data subject. (97) Where the processing is carried out by a public authority, except for courts or independent judicial authorities when acting in their judicial capacity, where, in the private sector, processing is carried out by a controller whose core activities consist of processing operations that require regular and systematic monitoring of the data subjects on a large scale, or where the core activities of the controller or the processor consist of processing on a large scale of special categories of personal data and data relating to criminal convictions and offences, a person with expert knowledge of data protection law and practices should assist the controller or processor to monitor internal compliance with this Regulation. In the private sector, the core activities of a controller relate to its primary activities and do not relate to the processing of personal data as ancillary activities. The necessary level of expert knowledge should be determined in particular according to the data processing operations carried out and the protection required for the personal data processed by the controller or the processor. Such data protection officers, whether or not they are an employee of the controller, should be in a position to perform their duties and tasks in an independent manner. (98) Associations or other bodies representing categories of controllers or processors should be encouraged to draw up codes of conduct, within the limits of this Regulation, so as to facilitate the effective application of this Regulation, taking account of the specific characteristics of the processing carried out in certain sectors and the specific needs of micro, small and medium enterprises. In particular, such codes of conduct could calibrate the obligations of controllers and processors, taking into account the risk likely to result from the processing for the rights and freedoms of natural persons. (99) When drawing up a code of conduct, or when amending or extending such a code, associations and other bodies representing categories of controllers or processors should consult relevant stakeholders, including data subjects where feasible, and have regard to submissions received and views expressed in response to such consultations. (100) In order to enhance transparency and compliance with this Regulation, the establishment of certification mechanisms and data protection seals and marks should be encouraged, allowing data subjects to quickly assess the level of data protection of relevant products and services. (101) Flows of personal data to and from countries outside the Union and international organisations are necessary for the expansion of international trade and international cooperation. The increase in such flows has raised new challenges and concerns with regard to the protection of personal data. However, when personal data are transferred from the Union to controllers, processors or other recipients in third countries or to international organisations, the level of protection of natural persons ensured in the Union by this Regulation should not be undermined, including in cases of onward transfers of personal data from the third country or international organisation to controllers, processors in the same or another third country or international organisation. In any event, transfers to third countries and international organisations may only be carried out in full compliance with this Regulation. A transfer could take place only if, subject to the other provisions of this Regulation, the conditions laid down in the provisions of this Regulation relating to the transfer of personal data to third countries or international organisations are complied with by the controller or processor. (102) This Regulation is without prejudice to international agreements concluded between the Union and third countries regulating the transfer of personal data including appropriate safeguards for the data subjects. Member States may conclude international agreements which involve the transfer of personal data to third countries or international organisations, as far as such agreements do not affect this Regulation or any other provisions of Union law and include an appropriate level of protection for the fundamental rights of the data subjects. (103) The Commission may decide with effect for the entire Union that a third country, a territory or specified sector within a third country, or an international organisation, offers an adequate level of data protection, thus providing legal certainty and uniformity throughout the Union as regards the third country or international organisation which is considered to provide such level of protection. In such cases, transfers of personal data to that third country or international organisation may take place without the need to obtain any further authorisation. The Commission may also decide, having given notice and a full statement setting out the reasons to the third country or international organisation, to revoke such a decision. (104) In line with the fundamental values on which the Union is founded, in particular the protection of human rights, the Commission should, in its assessment of the third country, or of a territory or specified sector within a third country, take into account how a particular third country respects the rule of law, access to justice as well as international human rights norms and standards and its general and sectoral law, including legislation concerning public security, defence and national security as well as public order and criminal law. The adoption of an adequacy decision with regard to a territory or a specified sector in a third country should take into account clear and objective criteria, such as specific processing activities and the scope of applicable legal standards and legislation in force in the third country. The third country should offer guarantees ensuring an adequate level of protection essentially equivalent to that ensured within the Union, in particular where personal data are processed in one or several specific sectors. In particular, the third country should ensure effective independent data protection supervision and should provide for cooperation mechanisms with the Member States' data protection authorities, and the data subjects should be provided with effective and enforceable rights and effective administrative and judicial redress. (105) Apart from the international commitments the third country or international organisation has entered into, the Commission should take account of obligations arising from the third country's or international organisation's participation in multilateral or regional systems in particular in relation to the protection of personal data, as well as the implementation of such obligations. In particular, the third country's accession to the Council of Europe Convention of 28 January 1981 for the Protection of Individuals with regard to the Automatic Processing of Personal Data and its Additional Protocol should be taken into account. The Commission should consult the Board when assessing the level of protection in third countries or international organisations. (106) The Commission should monitor the functioning of decisions on the level of protection in a third country, a territory or specified sector within a third country, or an international organisation, and monitor the functioning of decisions adopted on the basis of Article 25(6) or Article 26(4) of Directive 95/46/EC. In its adequacy decisions, the Commission should provide for a periodic review mechanism of their functioning. That periodic review should be conducted in consultation with the third country or international organisation in question and take into account all relevant developments in the third country or international organisation. For the purposes of monitoring and of carrying out the periodic reviews, the Commission should take into consideration the views and findings of the European Parliament and of the Council as well as of other relevant bodies and sources. The Commission should evaluate, within a reasonable time, the functioning of the latter decisions and report any relevant findings to the Committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council (12) as established under this Regulation, to the European Parliament and to the Council. (107) The Commission may recognise that a third country, a territory or a specified sector within a third country, or an international organisation no longer ensures an adequate level of data protection. Consequently the transfer of personal data to that third country or international organisation should be prohibited, unless the requirements in this Regulation relating to transfers subject to appropriate safeguards, including binding corporate rules, and derogations for specific situations are fulfilled. In that case, provision should be made for consultations between the Commission and such third countries or international organisations. The Commission should, in a timely manner, inform the third country or international organisation of the reasons and enter into consultations with it in order to remedy the situation. (108) In the absence of an adequacy decision, the controller or processor should take measures to compensate for the lack of data protection in a third country by way of appropriate safeguards for the data subject. Such appropriate safeguards may consist of making use of binding corporate rules, standard data protection clauses adopted by the Commission, standard data protection clauses adopted by a supervisory authority or contractual clauses authorised by a supervisory authority. Those safeguards should ensure compliance with data protection requirements and the rights of the data subjects appropriate to processing within the Union, including the availability of enforceable data subject rights and of effective legal remedies, including to obtain effective administrative or judicial redress and to claim compensation, in the Union or in a third country. They should relate in particular to compliance with the general principles relating to personal data processing, the principles of data protection by design and by default. Transfers may also be carried out by public authorities or bodies with public authorities or bodies in third countries or with international organisations with corresponding duties or functions, including on the basis of provisions to be inserted into administrative arrangements, such as a memorandum of understanding, providing for enforceable and effective rights for data subjects. Authorisation by the competent supervisory authority should be obtained when the safeguards are provided for in administrative arrangements that are not legally binding. (109) The possibility for the controller or processor to use standard data-protection clauses adopted by the Commission or by a supervisory authority should prevent controllers or processors neither from including the standard data-protection clauses in a wider contract, such as a contract between the processor and another processor, nor from adding other clauses or additional safeguards provided that they do not contradict, directly or indirectly, the standard contractual clauses adopted by the Commission or by a supervisory authority or prejudice the fundamental rights or freedoms of the data subjects. Controllers and processors should be encouraged to provide additional safeguards via contractual commitments that supplement standard protection clauses. (110) A group of undertakings, or a group of enterprises engaged in a joint economic activity, should be able to make use of approved binding corporate rules for its international transfers from the Union to organisations within the same group of undertakings, or group of enterprises engaged in a joint economic activity, provided that such corporate rules include all essential principles and enforceable rights to ensure appropriate safeguards for transfers or categories of transfers of personal data. (111) Provisions should be made for the possibility for transfers in certain circumstances where the data subject has given his or her explicit consent, where the transfer is occasional and necessary in relation to a contract or a legal claim, regardless of whether in a judicial procedure or whether in an administrative or any out-of-court procedure, including procedures before regulatory bodies. Provision should also be made for the possibility for transfers where important grounds of public interest laid down by Union or Member State law so require or where the transfer is made from a register established by law and intended for consultation by the public or persons having a legitimate interest. In the latter case, such a transfer should not involve the entirety of the personal data or entire categories of the data contained in the register and, when the register is intended for consultation by persons having a legitimate interest, the transfer should be made only at the request of those persons or, if they are to be the recipients, taking into full account the interests and fundamental rights of the data subject. (112) Those derogations should in particular apply to data transfers required and necessary for important reasons of public interest, for example in cases of international data exchange between competition authorities, tax or customs administrations, between financial supervisory authorities, between services competent for social security matters, or for public health, for example in the case of contact tracing for contagious diseases or in order to reduce and/or eliminate doping in sport. A transfer of personal data should also be regarded as lawful where it is necessary to protect an interest which is essential for the data subject's or another person's vital interests, including physical integrity or life, if the data subject is incapable of giving consent. In the absence of an adequacy decision, Union or Member State law may, for important reasons of public interest, expressly set limits to the transfer of specific categories of data to a third country or an international organisation. Member States should notify such provisions to the Commission. Any transfer to an international humanitarian organisation of personal data of a data subject who is physically or legally incapable of giving consent, with a view to accomplishing a task incumbent under the Geneva Conventions or to complying with international humanitarian law applicable in armed conflicts, could be considered to be necessary for an important reason of public interest or because it is in the vital interest of the data subject. (113) Transfers which can be qualified as not repetitive and that only concern a limited number of data subjects, could also be possible for the purposes of the compelling legitimate interests pursued by the controller, when those interests are not overridden by the interests or rights and freedoms of the data subject and when the controller has assessed all the circumstances surrounding the data transfer. The controller should give particular consideration to the nature of the personal data, the purpose and duration of the proposed processing operation or operations, as well as the situation in the country of origin, the third country and the country of final destination, and should provide suitable safeguards to protect fundamental rights and freedoms of natural persons with regard to the processing of their personal data. Such transfers should be possible only in residual cases where none of the other grounds for transfer are applicable. For scientific or historical research purposes or statistical purposes, the legitimate expectations of society for an increase of knowledge should be taken into consideration. The controller should inform the supervisory authority and the data subject about the transfer. (114) In any case, where the Commission has taken no decision on the adequate level of data protection in a third country, the controller or processor should make use of solutions that provide data subjects with enforceable and effective rights as regards the processing of their data in the Union once those data have been transferred so that that they will continue to benefit from fundamental rights and safeguards. (115) Some third countries adopt laws, regulations and other legal acts which purport to directly regulate the processing activities of natural and legal persons under the jurisdiction of the Member States. This may include judgments of courts or tribunals or decisions of administrative authorities in third countries requiring a controller or processor to transfer or disclose personal data, and which are not based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or a Member State. The extraterritorial application of those laws, regulations and other legal acts may be in breach of international law and may impede the attainment of the protection of natural persons ensured in the Union by this Regulation. Transfers should only be allowed where the conditions of this Regulation for a transfer to third countries are met. This may be the case, inter alia, where disclosure is necessary for an important ground of public interest recognised in Union or Member State law to which the controller is subject. (116) When personal data moves across borders outside the Union it may put at increased risk the ability of natural persons to exercise data protection rights in particular to protect themselves from the unlawful use or disclosure of that information. At the same time, supervisory authorities may find that they are unable to pursue complaints or conduct investigations relating to the activities outside their borders. Their efforts to work together in the cross-border context may also be hampered by insufficient preventative or remedial powers, inconsistent legal regimes, and practical obstacles like resource constraints. Therefore, there is a need to promote closer cooperation among data protection supervisory authorities to help them exchange information and carry out investigations with their international counterparts. For the purposes of developing international cooperation mechanisms to facilitate and provide international mutual assistance for the enforcement of legislation for the protection of personal data, the Commission and the supervisory authorities should exchange information and cooperate in activities related to the exercise of their powers with competent authorities in third countries, based on reciprocity and in accordance with this Regulation. (117) The establishment of supervisory authorities in Member States, empowered to perform their tasks and exercise their powers with complete independence, is an essential component of the protection of natural persons with regard to the processing of their personal data. Member States should be able to establish more than one supervisory authority, to reflect their constitutional, organisational and administrative structure. (118) The independence of supervisory authorities should not mean that the supervisory authorities cannot be subject to control or monitoring mechanisms regarding their financial expenditure or to judicial review. (119) Where a Member State establishes several supervisory authorities, it should establish by law mechanisms for ensuring the effective participation of those supervisory authorities in the consistency mechanism. That Member State should in particular designate the supervisory authority which functions as a single contact point for the effective participation of those authorities in the mechanism, to ensure swift and smooth cooperation with other supervisory authorities, the Board and the Commission. (120) Each supervisory authority should be provided with the financial and human resources, premises and infrastructure necessary for the effective performance of their tasks, including those related to mutual assistance and cooperation with other supervisory authorities throughout the Union. Each supervisory authority should have a separate, public annual budget, which may be part of the overall state or national budget. (121) The general conditions for the member or members of the supervisory authority should be laid down by law in each Member State and should in particular provide that those members are to be appointed, by means of a transparent procedure, either by the parliament, government or the head of State of the Member State on the basis of a proposal from the government, a member of the government, the parliament or a chamber of the parliament, or by an independent body entrusted under Member State law. In order to ensure the independence of the supervisory authority, the member or members should act with integrity, refrain from any action that is incompatible with their duties and should not, during their term of office, engage in any incompatible occupation, whether gainful or not. The supervisory authority should have its own staff, chosen by the supervisory authority or an independent body established by Member State law, which should be subject to the exclusive direction of the member or members of the supervisory authority. (122) Each supervisory authority should be competent on the territory of its own Member State to exercise the powers and to perform the tasks conferred on it in accordance with this Regulation. This should cover in particular the processing in the context of the activities of an establishment of the controller or processor on the territory of its own Member State, the processing of personal data carried out by public authorities or private bodies acting in the public interest, processing affecting data subjects on its territory or processing carried out by a controller or processor not established in the Union when targeting data subjects residing on its territory. This should include handling complaints lodged by a data subject, conducting investigations on the application of this Regulation and promoting public awareness of the risks, rules, safeguards and rights in relation to the processing of personal data. (123) The supervisory authorities should monitor the application of the provisions pursuant to this Regulation and contribute to its consistent application throughout the Union, in order to protect natural persons in relation to the processing of their personal data and to facilitate the free flow of personal data within the internal market. For that purpose, the supervisory authorities should cooperate with each other and with the Commission, without the need for any agreement between Member States on the provision of mutual assistance or on such cooperation. (124) Where the processing of personal data takes place in the context of the activities of an establishment of a controller or a processor in the Union and the controller or processor is established in more than one Member State, or where processing taking place in the context of the activities of a single establishment of a controller or processor in the Union substantially affects or is likely to substantially affect data subjects in more than one Member State, the supervisory authority for the main establishment of the controller or processor or for the single establishment of the controller or processor should act as lead authority. It should cooperate with the other authorities concerned, because the controller or processor has an establishment on the territory of their Member State, because data subjects residing on their territory are substantially affected, or because a complaint has been lodged with them. Also where a data subject not residing in that Member State has lodged a complaint, the supervisory authority with which such complaint has been lodged should also be a supervisory authority concerned. Within its tasks to issue guidelines on any question covering the application of this Regulation, the Board should be able to issue guidelines in particular on the criteria to be taken into account in order to ascertain whether the processing in question substantially affects data subjects in more than one Member State and on what constitutes a relevant and reasoned objection. (125) The lead authority should be competent to adopt binding decisions regarding measures applying the powers conferred on it in accordance with this Regulation. In its capacity as lead authority, the supervisory authority should closely involve and coordinate the supervisory authorities concerned in the decision-making process. Where the decision is to reject the complaint by the data subject in whole or in part, that decision should be adopted by the supervisory authority with which the complaint has been lodged. (126) The decision should be agreed jointly by the lead supervisory authority and the supervisory authorities concerned and should be directed towards the main or single establishment of the controller or processor and be binding on the controller and processor. The controller or processor should take the necessary measures to ensure compliance with this Regulation and the implementation of the decision notified by the lead supervisory authority to the main establishment of the controller or processor as regards the processing activities in the Union. (127) Each supervisory authority not acting as the lead supervisory authority should be competent to handle local cases where the controller or processor is established in more than one Member State, but the subject matter of the specific processing concerns only processing carried out in a single Member State and involves only data subjects in that single Member State, for example, where the subject matter concerns the processing of employees' personal data in the specific employment context of a Member State. In such cases, the supervisory authority should inform the lead supervisory authority without delay about the matter. After being informed, the lead supervisory authority should decide, whether it will handle the case pursuant to the provision on cooperation between the lead supervisory authority and other supervisory authorities concerned (‘one-stop-shop mechanism’), or whether the supervisory authority which informed it should handle the case at local level. When deciding whether it will handle the case, the lead supervisory authority should take into account whether there is an establishment of the controller or processor in the Member State of the supervisory authority which informed it in order to ensure effective enforcement of a decision vis-à-vis the controller or processor. Where the lead supervisory authority decides to handle the case, the supervisory authority which informed it should have the possibility to submit a draft for a decision, of which the lead supervisory authority should take utmost account when preparing its draft decision in that one-stop-shop mechanism. (128) The rules on the lead supervisory authority and the one-stop-shop mechanism should not apply where the processing is carried out by public authorities or private bodies in the public interest. In such cases the only supervisory authority competent to exercise the powers conferred to it in accordance with this Regulation should be the supervisory authority of the Member State where the public authority or private body is established. (129) In order to ensure consistent monitoring and enforcement of this Regulation throughout the Union, the supervisory authorities should have in each Member State the same tasks and effective powers, including powers of investigation, corrective powers and sanctions, and authorisation and advisory powers, in particular in cases of complaints from natural persons, and without prejudice to the powers of prosecutorial authorities under Member State law, to bring infringements of this Regulation to the attention of the judicial authorities and engage in legal proceedings. Such powers should also include the power to impose a temporary or definitive limitation, including a ban, on processing. Member States may specify other tasks related to the protection of personal data under this Regulation. The powers of supervisory authorities should be exercised in accordance with appropriate procedural safeguards set out in Union and Member State law, impartially, fairly and within a reasonable time. In particular each measure should be appropriate, necessary and proportionate in view of ensuring compliance with this Regulation, taking into account the circumstances of each individual case, respect the right of every person to be heard before any individual measure which would affect him or her adversely is taken and avoid superfluous costs and excessive inconveniences for the persons concerned. Investigatory powers as regards access to premises should be exercised in accordance with specific requirements in Member State procedural law, such as the requirement to obtain a prior judicial authorisation. Each legally binding measure of the supervisory authority should be in writing, be clear and unambiguous, indicate the supervisory authority which has issued the measure, the date of issue of the measure, bear the signature of the head, or a member of the supervisory authority authorised by him or her, give the reasons for the measure, and refer to the right of an effective remedy. This should not preclude additional requirements pursuant to Member State procedural law. The adoption of a legally binding decision implies that it may give rise to judicial review in the Member State of the supervisory authority that adopted the decision. (130) Where the supervisory authority with which the complaint has been lodged is not the lead supervisory authority, the lead supervisory authority should closely cooperate with the supervisory authority with which the complaint has been lodged in accordance with the provisions on cooperation and consistency laid down in this Regulation. In such cases, the lead supervisory authority should, when taking measures intended to produce legal effects, including the imposition of administrative fines, take utmost account of the view of the supervisory authority with which the complaint has been lodged and which should remain competent to carry out any investigation on the territory of its own Member State in liaison with the competent supervisory authority. (131) Where another supervisory authority should act as a lead supervisory authority for the processing activities of the controller or processor but the concrete subject matter of a complaint or the possible infringement concerns only processing activities of the controller or processor in the Member State where the complaint has been lodged or the possible infringement detected and the matter does not substantially affect or is not likely to substantially affect data subjects in other Member States, the supervisory authority receiving a complaint or detecting or being informed otherwise of situations that entail possible infringements of this Regulation should seek an amicable settlement with the controller and, if this proves unsuccessful, exercise its full range of powers. This should include: specific processing carried out in the territory of the Member State of the supervisory authority or with regard to data subjects on the territory of that Member State; processing that is carried out in the context of an offer of goods or services specifically aimed at data subjects in the territory of the Member State of the supervisory authority; or processing that has to be assessed taking into account relevant legal obligations under Member State law. (132) Awareness-raising activities by supervisory authorities addressed to the public should include specific measures directed at controllers and processors, including micro, small and medium-sized enterprises, as well as natural persons in particular in the educational context. (133) The supervisory authorities should assist each other in performing their tasks and provide mutual assistance, so as to ensure the consistent application and enforcement of this Regulation in the internal market. A supervisory authority requesting mutual assistance may adopt a provisional measure if it receives no response to a request for mutual assistance within one month of the receipt of that request by the other supervisory authority. (134) Each supervisory authority should, where appropriate, participate in joint operations with other supervisory authorities. The requested supervisory authority should be obliged to respond to the request within a specified time period. (135) In order to ensure the consistent application of this Regulation throughout the Union, a consistency mechanism for cooperation between the supervisory authorities should be established. That mechanism should in particular apply where a supervisory authority intends to adopt a measure intended to produce legal effects as regards processing operations which substantially affect a significant number of data subjects in several Member States. It should also apply where any supervisory authority concerned or the Commission requests that such matter should be handled in the consistency mechanism. That mechanism should be without prejudice to any measures that the Commission may take in the exercise of its powers under the Treaties. (136) In applying the consistency mechanism, the Board should, within a determined period of time, issue an opinion, if a majority of its members so decides or if so requested by any supervisory authority concerned or the Commission. The Board should also be empowered to adopt legally binding decisions where there are disputes between supervisory authorities. For that purpose, it should issue, in principle by a two-thirds majority of its members, legally binding decisions in clearly specified cases where there are conflicting views among supervisory authorities, in particular in the cooperation mechanism between the lead supervisory authority and supervisory authorities concerned on the merits of the case, in particular whether there is an infringement of this Regulation. (137) There may be an urgent need to act in order to protect the rights and freedoms of data subjects, in particular when the danger exists that the enforcement of a right of a data subject could be considerably impeded. A supervisory authority should therefore be able to adopt duly justified provisional measures on its territory with a specified period of validity which should not exceed three months. (138) The application of such mechanism should be a condition for the lawfulness of a measure intended to produce legal effects by a supervisory authority in those cases where its application is mandatory. In other cases of cross-border relevance, the cooperation mechanism between the lead supervisory authority and supervisory authorities concerned should be applied and mutual assistance and joint operations might be carried out between the supervisory authorities concerned on a bilateral or multilateral basis without triggering the consistency mechanism. (139) In order to promote the consistent application of this Regulation, the Board should be set up as an independent body of the Union. To fulfil its objectives, the Board should have legal personality. The Board should be represented by its Chair. It should replace the Working Party on the Protection of Individuals with Regard to the Processing of Personal Data established by Directive 95/46/EC. It should consist of the head of a supervisory authority of each Member State and the European Data Protection Supervisor or their respective representatives. The Commission should participate in the Board's activities without voting rights and the European Data Protection Supervisor should have specific voting rights. The Board should contribute to the consistent application of this Regulation throughout the Union, including by advising the Commission, in particular on the level of protection in third countries or international organisations, and promoting cooperation of the supervisory authorities throughout the Union. The Board should act independently when performing its tasks. (140) The Board should be assisted by a secretariat provided by the European Data Protection Supervisor. The staff of the European Data Protection Supervisor involved in carrying out the tasks conferred on the Board by this Regulation should perform its tasks exclusively under the instructions of, and report to, the Chair of the Board. (141) Every data subject should have the right to lodge a complaint with a single supervisory authority, in particular in the Member State of his or her habitual residence, and the right to an effective judicial remedy in accordance with Article 47 of the Charter if the data subject considers that his or her rights under this Regulation are infringed or where the supervisory authority does not act on a complaint, partially or wholly rejects or dismisses a complaint or does not act where such action is necessary to protect the rights of the data subject. The investigation following a complaint should be carried out, subject to judicial review, to the extent that is appropriate in the specific case. The supervisory authority should inform the data subject of the progress and the outcome of the complaint within a reasonable period. If the case requires further investigation or coordination with another supervisory authority, intermediate information should be given to the data subject. In order to facilitate the submission of complaints, each supervisory authority should take measures such as providing a complaint submission form which can also be completed electronically, without excluding other means of communication. (142) Where a data subject considers that his or her rights under this Regulation are infringed, he or she should have the right to mandate a not-for-profit body, organisation or association which is constituted in accordance with the law of a Member State, has statutory objectives which are in the public interest and is active in the field of the protection of personal data to lodge a complaint on his or her behalf with a supervisory authority, exercise the right to a judicial remedy on behalf of data subjects or, if provided for in Member State law, exercise the right to receive compensation on behalf of data subjects. A Member State may provide for such a body, organisation or association to have the right to lodge a complaint in that Member State, independently of a data subject's mandate, and the right to an effective judicial remedy where it has reasons to consider that the rights of a data subject have been infringed as a result of the processing of personal data which infringes this Regulation. That body, organisation or association may not be allowed to claim compensation on a data subject's behalf independently of the data subject's mandate. (143) Any natural or legal person has the right to bring an action for annulment of decisions of the Board before the Court of Justice under the conditions provided for in Article 263 TFEU. As addressees of such decisions, the supervisory authorities concerned which wish to challenge them have to bring action within two months of being notified of them, in accordance with Article 263 TFEU. Where decisions of the Board are of direct and individual concern to a controller, processor or complainant, the latter may bring an action for annulment against those decisions within two months of their publication on the website of the Board, in accordance with Article 263 TFEU. Without prejudice to this right under Article 263 TFEU, each natural or legal person should have an effective judicial remedy before the competent national court against a decision of a supervisory authority which produces legal effects concerning that person. Such a decision concerns in particular the exercise of investigative, corrective and authorisation powers by the supervisory authority or the dismissal or rejection of complaints. However, the right to an effective judicial remedy does not encompass measures taken by supervisory authorities which are not legally binding, such as opinions issued by or advice provided by the supervisory authority. Proceedings against a supervisory authority should be brought before the courts of the Member State where the supervisory authority is established and should be conducted in accordance with that Member State's procedural law. Those courts should exercise full jurisdiction, which should include jurisdiction to examine all questions of fact and law relevant to the dispute before them. Where a complaint has been rejected or dismissed by a supervisory authority, the complainant may bring proceedings before the courts in the same Member State. In the context of judicial remedies relating to the application of this Regulation, national courts which consider a decision on the question necessary to enable them to give judgment, may, or in the case provided for in Article 267 TFEU, must, request the Court of Justice to give a preliminary ruling on the interpretation of Union law, including this Regulation. Furthermore, where a decision of a supervisory authority implementing a decision of the Board is challenged before a national court and the validity of the decision of the Board is at issue, that national court does not have the power to declare the Board's decision invalid but must refer the question of validity to the Court of Justice in accordance with Article 267 TFEU as interpreted by the Court of Justice, where it considers the decision invalid. However, a national court may not refer a question on the validity of the decision of the Board at the request of a natural or legal person which had the opportunity to bring an action for annulment of that decision, in particular if it was directly and individually concerned by that decision, but had not done so within the period laid down in Article 263 TFEU. (144) Where a court seized of proceedings against a decision by a supervisory authority has reason to believe that proceedings concerning the same processing, such as the same subject matter as regards processing by the same controller or processor, or the same cause of action, are brought before a competent court in another Member State, it should contact that court in order to confirm the existence of such related proceedings. If related proceedings are pending before a court in another Member State, any court other than the court first seized may stay its proceedings or may, on request of one of the parties, decline jurisdiction in favour of the court first seized if that court has jurisdiction over the proceedings in question and its law permits the consolidation of such related proceedings. Proceedings are deemed to be related where they are so closely connected that it is expedient to hear and determine them together in order to avoid the risk of irreconcilable judgments resulting from separate proceedings. (145) For proceedings against a controller or processor, the plaintiff should have the choice to bring the action before the courts of the Member States where the controller or processor has an establishment or where the data subject resides, unless the controller is a public authority of a Member State acting in the exercise of its public powers. (146) The controller or processor should compensate any damage which a person may suffer as a result of processing that infringes this Regulation. The controller or processor should be exempt from liability if it proves that it is not in any way responsible for the damage. The concept of damage should be broadly interpreted in the light of the case-law of the Court of Justice in a manner which fully reflects the objectives of this Regulation. This is without prejudice to any claims for damage deriving from the violation of other rules in Union or Member State law. Processing that infringes this Regulation also includes processing that infringes delegated and implementing acts adopted in accordance with this Regulation and Member State law specifying rules of this Regulation. Data subjects should receive full and effective compensation for the damage they have suffered. Where controllers or processors are involved in the same processing, each controller or processor should be held liable for the entire damage. However, where they are joined to the same judicial proceedings, in accordance with Member State law, compensation may be apportioned according to the responsibility of each controller or processor for the damage caused by the processing, provided that full and effective compensation of the data subject who suffered the damage is ensured. Any controller or processor which has paid full compensation may subsequently institute recourse proceedings against other controllers or processors involved in the same processing. (147) Where specific rules on jurisdiction are contained in this Regulation, in particular as regards proceedings seeking a judicial remedy including compensation, against a controller or processor, general jurisdiction rules such as those of Regulation (EU) No 1215/2012 of the European Parliament and of the Council (13) should not prejudice the application of such specific rules. (148) In order to strengthen the enforcement of the rules of this Regulation, penalties including administrative fines should be imposed for any infringement of this Regulation, in addition to, or instead of appropriate measures imposed by the supervisory authority pursuant to this Regulation. In a case of a minor infringement or if the fine likely to be imposed would constitute a disproportionate burden to a natural person, a reprimand may be issued instead of a fine. Due regard should however be given to the nature, gravity and duration of the infringement, the intentional character of the infringement, actions taken to mitigate the damage suffered, degree of responsibility or any relevant previous infringements, the manner in which the infringement became known to the supervisory authority, compliance with measures ordered against the controller or processor, adherence to a code of conduct and any other aggravating or mitigating factor. The imposition of penalties including administrative fines should be subject to appropriate procedural safeguards in accordance with the general principles of Union law and the Charter, including effective judicial protection and due process. (149) Member States should be able to lay down the rules on criminal penalties for infringements of this Regulation, including for infringements of national rules adopted pursuant to and within the limits of this Regulation. Those criminal penalties may also allow for the deprivation of the profits obtained through infringements of this Regulation. However, the imposition of criminal penalties for infringements of such national rules and of administrative penalties should not lead to a breach of the principle of ne bis in idem, as interpreted by the Court of Justice. (150) In order to strengthen and harmonise administrative penalties for infringements of this Regulation, each supervisory authority should have the power to impose administrative fines. This Regulation should indicate infringements and the upper limit and criteria for setting the related administrative fines, which should be determined by the competent supervisory authority in each individual case, taking into account all relevant circumstances of the specific situation, with due regard in particular to the nature, gravity and duration of the infringement and of its consequences and the measures taken to ensure compliance with the obligations under this Regulation and to prevent or mitigate the consequences of the infringement. Where administrative fines are imposed on an undertaking, an undertaking should be understood to be an undertaking in accordance with Articles 101 and 102 TFEU for those purposes. Where administrative fines are imposed on persons that are not an undertaking, the supervisory authority should take account of the general level of income in the Member State as well as the economic situation of the person in considering the appropriate amount of the fine. The consistency mechanism may also be used to promote a consistent application of administrative fines. It should be for the Member States to determine whether and to which extent public authorities should be subject to administrative fines. Imposing an administrative fine or giving a warning does not affect the application of other powers of the supervisory authorities or of other penalties under this Regulation. (151) The legal systems of Denmark and Estonia do not allow for administrative fines as set out in this Regulation. The rules on administrative fines may be applied in such a manner that in Denmark the fine is imposed by competent national courts as a criminal penalty and in Estonia the fine is imposed by the supervisory authority in the framework of a misdemeanour procedure, provided that such an application of the rules in those Member States has an equivalent effect to administrative fines imposed by supervisory authorities. Therefore the competent national courts should take into account the recommendation by the supervisory authority initiating the fine. In any event, the fines imposed should be effective, proportionate and dissuasive. (152) Where this Regulation does not harmonise administrative penalties or where necessary in other cases, for example in cases of serious infringements of this Regulation, Member States should implement a system which provides for effective, proportionate and dissuasive penalties. The nature of such penalties, criminal or administrative, should be determined by Member State law. (153) Member States law should reconcile the rules governing freedom of expression and information, including journalistic, academic, artistic and or literary expression with the right to the protection of personal data pursuant to this Regulation. The processing of personal data solely for journalistic purposes, or for the purposes of academic, artistic or literary expression should be subject to derogations or exemptions from certain provisions of this Regulation if necessary to reconcile the right to the protection of personal data with the right to freedom of expression and information, as enshrined in Article 11 of the Charter. This should apply in particular to the processing of personal data in the audiovisual field and in news archives and press libraries. Therefore, Member States should adopt legislative measures which lay down the exemptions and derogations necessary for the purpose of balancing those fundamental rights. Member States should adopt such exemptions and derogations on general principles, the rights of the data subject, the controller and the processor, the transfer of personal data to third countries or international organisations, the independent supervisory authorities, cooperation and consistency, and specific data-processing situations. Where such exemptions or derogations differ from one Member State to another, the law of the Member State to which the controller is subject should apply. In order to take account of the importance of the right to freedom of expression in every democratic society, it is necessary to interpret notions relating to that freedom, such as journalism, broadly. (154) This Regulation allows the principle of public access to official documents to be taken into account when applying this Regulation. Public access to official documents may be considered to be in the public interest. Personal data in documents held by a public authority or a public body should be able to be publicly disclosed by that authority or body if the disclosure is provided for by Union or Member State law to which the public authority or public body is subject. Such laws should reconcile public access to official documents and the reuse of public sector information with the right to the protection of personal data and may therefore provide for the necessary reconciliation with the right to the protection of personal data pursuant to this Regulation. The reference to public authorities and bodies should in that context include all authorities or other bodies covered by Member State law on public access to documents. Directive 2003/98/EC of the European Parliament and of the Council (14) leaves intact and in no way affects the level of protection of natural persons with regard to the processing of personal data under the provisions of Union and Member State law, and in particular does not alter the obligations and rights set out in this Regulation. In particular, that Directive should not apply to documents to which access is excluded or restricted by virtue of the access regimes on the grounds of protection of personal data, and parts of documents accessible by virtue of those regimes which contain personal data the re-use of which has been provided for by law as being incompatible with the law concerning the protection of natural persons with regard to the processing of personal data. (155) Member State law or collective agreements, including ‘works agreements’, may provide for specific rules on the processing of employees' personal data in the employment context, in particular for the conditions under which personal data in the employment context may be processed on the basis of the consent of the employee, the purposes of the recruitment, the performance of the contract of employment, including discharge of obligations laid down by law or by collective agreements, management, planning and organisation of work, equality and diversity in the workplace, health and safety at work, and for the purposes of the exercise and enjoyment, on an individual or collective basis, of rights and benefits related to employment, and for the purpose of the termination of the employment relationship. (156) The processing of personal data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes should be subject to appropriate safeguards for the rights and freedoms of the data subject pursuant to this Regulation. Those safeguards should ensure that technical and organisational measures are in place in order to ensure, in particular, the principle of data minimisation. The further processing of personal data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes is to be carried out when the controller has assessed the feasibility to fulfil those purposes by processing data which do not permit or no longer permit the identification of data subjects, provided that appropriate safeguards exist (such as, for instance, pseudonymisation of the data). Member States should provide for appropriate safeguards for the processing of personal data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. Member States should be authorised to provide, under specific conditions and subject to appropriate safeguards for data subjects, specifications and derogations with regard to the information requirements and rights to rectification, to erasure, to be forgotten, to restriction of processing, to data portability, and to object when processing personal data for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. The conditions and safeguards in question may entail specific procedures for data subjects to exercise those rights if this is appropriate in the light of the purposes sought by the specific processing along with technical and organisational measures aimed at minimising the processing of personal data in pursuance of the proportionality and necessity principles. The processing of personal data for scientific purposes should also comply with other relevant legislation such as on clinical trials. (157) By coupling information from registries, researchers can obtain new knowledge of great value with regard to widespread medical conditions such as cardiovascular disease, cancer and depression. On the basis of registries, research results can be enhanced, as they draw on a larger population. Within social science, research on the basis of registries enables researchers to obtain essential knowledge about the long-term correlation of a number of social conditions such as unemployment and education with other life conditions. Research results obtained through registries provide solid, high-quality knowledge which can provide the basis for the formulation and implementation of knowledge-based policy, improve the quality of life for a number of people and improve the efficiency of social services. In order to facilitate scientific research, personal data can be processed for scientific research purposes, subject to appropriate conditions and safeguards set out in Union or Member State law. (158) Where personal data are processed for archiving purposes, this Regulation should also apply to that processing, bearing in mind that this Regulation should not apply to deceased persons. Public authorities or public or private bodies that hold records of public interest should be services which, pursuant to Union or Member State law, have a legal obligation to acquire, preserve, appraise, arrange, describe, communicate, promote, disseminate and provide access to records of enduring value for general public interest. Member States should also be authorised to provide for the further processing of personal data for archiving purposes, for example with a view to providing specific information related to the political behaviour under former totalitarian state regimes, genocide, crimes against humanity, in particular the Holocaust, or war crimes. (159) Where personal data are processed for scientific research purposes, this Regulation should also apply to that processing. For the purposes of this Regulation, the processing of personal data for scientific research purposes should be interpreted in a broad manner including for example technological development and demonstration, fundamental research, applied research and privately funded research. In addition, it should take into account the Union's objective under Article 179(1) TFEU of achieving a European Research Area. Scientific research purposes should also include studies conducted in the public interest in the area of public health. To meet the specificities of processing personal data for scientific research purposes, specific conditions should apply in particular as regards the publication or otherwise disclosure of personal data in the context of scientific research purposes. If the result of scientific research in particular in the health context gives reason for further measures in the interest of the data subject, the general rules of this Regulation should apply in view of those measures. (160) Where personal data are processed for historical research purposes, this Regulation should also apply to that processing. This should also include historical research and research for genealogical purposes, bearing in mind that this Regulation should not apply to deceased persons. (161) For the purpose of consenting to the participation in scientific research activities in clinical trials, the relevant provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council (15) should apply. (162) Where personal data are processed for statistical purposes, this Regulation should apply to that processing. Union or Member State law should, within the limits of this Regulation, determine statistical content, control of access, specifications for the processing of personal data for statistical purposes and appropriate measures to safeguard the rights and freedoms of the data subject and for ensuring statistical confidentiality. Statistical purposes mean any operation of collection and the processing of personal data necessary for statistical surveys or for the production of statistical results. Those statistical results may further be used for different purposes, including a scientific research purpose. The statistical purpose implies that the result of processing for statistical purposes is not personal data, but aggregate data, and that this result or the personal data are not used in support of measures or decisions regarding any particular natural person. (163) The confidential information which the Union and national statistical authorities collect for the production of official European and official national statistics should be protected. European statistics should be developed, produced and disseminated in accordance with the statistical principles as set out in Article 338(2) TFEU, while national statistics should also comply with Member State law. Regulation (EC) No 223/2009 of the European Parliament and of the Council (16) provides further specifications on statistical confidentiality for European statistics. (164) As regards the powers of the supervisory authorities to obtain from the controller or processor access to personal data and access to their premises, Member States may adopt by law, within the limits of this Regulation, specific rules in order to safeguard the professional or other equivalent secrecy obligations, in so far as necessary to reconcile the right to the protection of personal data with an obligation of professional secrecy. This is without prejudice to existing Member State obligations to adopt rules on professional secrecy where required by Union law. (165) This Regulation respects and does not prejudice the status under existing constitutional law of churches and religious associations or communities in the Member States, as recognised in Article 17 TFEU. (166) In order to fulfil the objectives of this Regulation, namely to protect the fundamental rights and freedoms of natural persons and in particular their right to the protection of personal data and to ensure the free movement of personal data within the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. In particular, delegated acts should be adopted in respect of criteria and requirements for certification mechanisms, information to be presented by standardised icons and procedures for providing such icons. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (167) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission when provided for by this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011. In that context, the Commission should consider specific measures for micro, small and medium-sized enterprises. (168) The examination procedure should be used for the adoption of implementing acts on standard contractual clauses between controllers and processors and between processors; codes of conduct; technical standards and mechanisms for certification; the adequate level of protection afforded by a third country, a territory or a specified sector within that third country, or an international organisation; standard protection clauses; formats and procedures for the exchange of information by electronic means between controllers, processors and supervisory authorities for binding corporate rules; mutual assistance; and arrangements for the exchange of information by electronic means between supervisory authorities, and between supervisory authorities and the Board. (169) The Commission should adopt immediately applicable implementing acts where available evidence reveals that a third country, a territory or a specified sector within that third country, or an international organisation does not ensure an adequate level of protection, and imperative grounds of urgency so require. (170) Since the objective of this Regulation, namely to ensure an equivalent level of protection of natural persons and the free flow of personal data throughout the Union, cannot be sufficiently achieved by the Member States and can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. (171) Directive 95/46/EC should be repealed by this Regulation. Processing already under way on the date of application of this Regulation should be brought into conformity with this Regulation within the period of two years after which this Regulation enters into force. Where processing is based on consent pursuant to Directive 95/46/EC, it is not necessary for the data subject to give his or her consent again if the manner in which the consent has been given is in line with the conditions of this Regulation, so as to allow the controller to continue such processing after the date of application of this Regulation. Commission decisions adopted and authorisations by supervisory authorities based on Directive 95/46/EC remain in force until amended, replaced or repealed. (172) The European Data Protection Supervisor was consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 and delivered an opinion on 7 March 2012 (17). (173) This Regulation should apply to all matters concerning the protection of fundamental rights and freedoms vis-à-vis the processing of personal data which are not subject to specific obligations with the same objective set out in Directive 2002/58/EC of the European Parliament and of the Council (18), including the obligations on the controller and the rights of natural persons. In order to clarify the relationship between this Regulation and Directive 2002/58/EC, that Directive should be amended accordingly. Once this Regulation is adopted, Directive 2002/58/EC should be reviewed in particular in order to ensure consistency with this Regulation, HAVE ADOPTED THIS REGULATION: CHAPTER I General provisions Article 1 Subject-matter and objectives 1. This Regulation lays down rules relating to the protection of natural persons with regard to the processing of personal data and rules relating to the free movement of personal data. 2. This Regulation protects fundamental rights and freedoms of natural persons and in particular their right to the protection of personal data. 3. The free movement of personal data within the Union shall be neither restricted nor prohibited for reasons connected with the protection of natural persons with regard to the processing of personal data. Article 2 Material scope 1. This Regulation applies to the processing of personal data wholly or partly by automated means and to the processing other than by automated means of personal data which form part of a filing system or are intended to form part of a filing system. 2. This Regulation does not apply to the processing of personal data: (a) in the course of an activity which falls outside the scope of Union law; (b) by the Member States when carrying out activities which fall within the scope of Chapter 2 of Title V of the TEU; (c) by a natural person in the course of a purely personal or household activity; (d) by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security. 3. For the processing of personal data by the Union institutions, bodies, offices and agencies, Regulation (EC) No 45/2001 applies. Regulation (EC) No 45/2001 and other Union legal acts applicable to such processing of personal data shall be adapted to the principles and rules of this Regulation in accordance with Article 98. 4. This Regulation shall be without prejudice to the application of Directive 2000/31/EC, in particular of the liability rules of intermediary service providers in Articles 12 to 15 of that Directive. Article 3 Territorial scope 1. This Regulation applies to the processing of personal data in the context of the activities of an establishment of a controller or a processor in the Union, regardless of whether the processing takes place in the Union or not. 2. This Regulation applies to the processing of personal data of data subjects who are in the Union by a controller or processor not established in the Union, where the processing activities are related to: (a) the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data subjects in the Union; or (b) the monitoring of their behaviour as far as their behaviour takes place within the Union. 3. This Regulation applies to the processing of personal data by a controller not established in the Union, but in a place where Member State law applies by virtue of public international law. Article 4 Definitions For the purposes of this Regulation: (1) ‘personal data’ means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person; (2) ‘processing’ means any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction; (3) ‘restriction of processing’ means the marking of stored personal data with the aim of limiting their processing in the future; (4) ‘profiling’ means any form of automated processing of personal data consisting of the use of personal data to evaluate certain personal aspects relating to a natural person, in particular to analyse or predict aspects concerning that natural person's performance at work, economic situation, health, personal preferences, interests, reliability, behaviour, location or movements; (5) ‘pseudonymisation’ means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person; (6) ‘filing system’ means any structured set of personal data which are accessible according to specific criteria, whether centralised, decentralised or dispersed on a functional or geographical basis; (7) ‘controller’ means the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union or Member State law, the controller or the specific criteria for its nomination may be provided for by Union or Member State law; (8) ‘processor’ means a natural or legal person, public authority, agency or other body which processes personal data on behalf of the controller; (9) ‘recipient’ means a natural or legal person, public authority, agency or another body, to which the personal data are disclosed, whether a third party or not. However, public authorities which may receive personal data in the framework of a particular inquiry in accordance with Union or Member State law shall not be regarded as recipients; the processing of those data by those public authorities shall be in compliance with the applicable data protection rules according to the purposes of the processing; (10) ‘third party’ means a natural or legal person, public authority, agency or body other than the data subject, controller, processor and persons who, under the direct authority of the controller or processor, are authorised to process personal data; (11) ‘consent’ of the data subject means any freely given, specific, informed and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her; (12) ‘personal data breach’ means a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed; (13) ‘genetic data’ means personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question; (14) ‘biometric data’ means personal data resulting from specific technical processing relating to the physical, physiological or behavioural characteristics of a natural person, which allow or confirm the unique identification of that natural person, such as facial images or dactyloscopic data; (15) ‘data concerning health’ means personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his or her health status; (16) ‘main establishment’ means: (a) as regards a controller with establishments in more than one Member State, the place of its central administration in the Union, unless the decisions on the purposes and means of the processing of personal data are taken in another establishment of the controller in the Union and the latter establishment has the power to have such decisions implemented, in which case the establishment having taken such decisions is to be considered to be the main establishment; (b) as regards a processor with establishments in more than one Member State, the place of its central administration in the Union, or, if the processor has no central administration in the Union, the establishment of the processor in the Union where the main processing activities in the context of the activities of an establishment of the processor take place to the extent that the processor is subject to specific obligations under this Regulation; (17) ‘representative’ means a natural or legal person established in the Union who, designated by the controller or processor in writing pursuant to Article 27, represents the controller or processor with regard to their respective obligations under this Regulation; (18) ‘enterprise’ means a natural or legal person engaged in an economic activity, irrespective of its legal form, including partnerships or associations regularly engaged in an economic activity; (19) ‘group of undertakings’ means a controlling undertaking and its controlled undertakings; (20) ‘binding corporate rules’ means personal data protection policies which are adhered to by a controller or processor established on the territory of a Member State for transfers or a set of transfers of personal data to a controller or processor in one or more third countries within a group of undertakings, or group of enterprises engaged in a joint economic activity; (21) ‘supervisory authority’ means an independent public authority which is established by a Member State pursuant to Article 51; (22) ‘supervisory authority concerned’ means a supervisory authority which is concerned by the processing of personal data because: (a) the controller or processor is established on the territory of the Member State of that supervisory authority; (b) data subjects residing in the Member State of that supervisory authority are substantially affected or likely to be substantially affected by the processing; or (c) a complaint has been lodged with that supervisory authority; (23) ‘cross-border processing’ means either: (a) processing of personal data which takes place in the context of the activities of establishments in more than one Member State of a controller or processor in the Union where the controller or processor is established in more than one Member State; or (b) processing of personal data which takes place in the context of the activities of a single establishment of a controller or processor in the Union but which substantially affects or is likely to substantially affect data subjects in more than one Member State. (24) ‘relevant and reasoned objection’ means an objection to a draft decision as to whether there is an infringement of this Regulation, or whether envisaged action in relation to the controller or processor complies with this Regulation, which clearly demonstrates the significance of the risks posed by the draft decision as regards the fundamental rights and freedoms of data subjects and, where applicable, the free flow of personal data within the Union; (25) ‘information society service’ means a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council (19); (26) ‘international organisation’ means an organisation and its subordinate bodies governed by public international law, or any other body which is set up by, or on the basis of, an agreement between two or more countries. CHAPTER II Principles Article 5 Principles relating to processing of personal data 1. Personal data shall be: (a) processed lawfully, fairly and in a transparent manner in relation to the data subject (‘lawfulness, fairness and transparency’); (b) collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes; further processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes shall, in accordance with Article 89(1), not be considered to be incompatible with the initial purposes (‘purpose limitation’); (c) adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed (‘data minimisation’); (d) accurate and, where necessary, kept up to date; every reasonable step must be taken to ensure that personal data that are inaccurate, having regard to the purposes for which they are processed, are erased or rectified without delay (‘accuracy’); (e) kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed; personal data may be stored for longer periods insofar as the personal data will be processed solely for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) subject to implementation of the appropriate technical and organisational measures required by this Regulation in order to safeguard the rights and freedoms of the data subject (‘storage limitation’); (f) processed in a manner that ensures appropriate security of the personal data, including protection against unauthorised or unlawful processing and against accidental loss, destruction or damage, using appropriate technical or organisational measures (‘integrity and confidentiality’). 2. The controller shall be responsible for, and be able to demonstrate compliance with, paragraph 1 (‘accountability’). Article 6 Lawfulness of processing 1. Processing shall be lawful only if and to the extent that at least one of the following applies: (a) the data subject has given consent to the processing of his or her personal data for one or more specific purposes; (b) processing is necessary for the performance of a contract to which the data subject is party or in order to take steps at the request of the data subject prior to entering into a contract; (c) processing is necessary for compliance with a legal obligation to which the controller is subject; (d) processing is necessary in order to protect the vital interests of the data subject or of another natural person; (e) processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller; (f) processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party, except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. Point (f) of the first subparagraph shall not apply to processing carried out by public authorities in the performance of their tasks. 2. Member States may maintain or introduce more specific provisions to adapt the application of the rules of this Regulation with regard to processing for compliance with points (c) and (e) of paragraph 1 by determining more precisely specific requirements for the processing and other measures to ensure lawful and fair processing including for other specific processing situations as provided for in Chapter IX. 3. The basis for the processing referred to in point (c) and (e) of paragraph 1 shall be laid down by: (a) Union law; or (b) Member State law to which the controller is subject. The purpose of the processing shall be determined in that legal basis or, as regards the processing referred to in point (e) of paragraph 1, shall be necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. That legal basis may contain specific provisions to adapt the application of rules of this Regulation, inter alia: the general conditions governing the lawfulness of processing by the controller; the types of data which are subject to the processing; the data subjects concerned; the entities to, and the purposes for which, the personal data may be disclosed; the purpose limitation; storage periods; and processing operations and processing procedures, including measures to ensure lawful and fair processing such as those for other specific processing situations as provided for in Chapter IX. The Union or the Member State law shall meet an objective of public interest and be proportionate to the legitimate aim pursued. 4. Where the processing for a purpose other than that for which the personal data have been collected is not based on the data subject's consent or on a Union or Member State law which constitutes a necessary and proportionate measure in a democratic society to safeguard the objectives referred to in Article 23(1), the controller shall, in order to ascertain whether processing for another purpose is compatible with the purpose for which the personal data are initially collected, take into account, inter alia: (a) any link between the purposes for which the personal data have been collected and the purposes of the intended further processing; (b) the context in which the personal data have been collected, in particular regarding the relationship between data subjects and the controller; (c) the nature of the personal data, in particular whether special categories of personal data are processed, pursuant to Article 9, or whether personal data related to criminal convictions and offences are processed, pursuant to Article 10; (d) the possible consequences of the intended further processing for data subjects; (e) the existence of appropriate safeguards, which may include encryption or pseudonymisation. Article 7 Conditions for consent 1. Where processing is based on consent, the controller shall be able to demonstrate that the data subject has consented to processing of his or her personal data. 2. If the data subject's consent is given in the context of a written declaration which also concerns other matters, the request for consent shall be presented in a manner which is clearly distinguishable from the other matters, in an intelligible and easily accessible form, using clear and plain language. Any part of such a declaration which constitutes an infringement of this Regulation shall not be binding. 3. The data subject shall have the right to withdraw his or her consent at any time. The withdrawal of consent shall not affect the lawfulness of processing based on consent before its withdrawal. Prior to giving consent, the data subject shall be informed thereof. It shall be as easy to withdraw as to give consent. 4. When assessing whether consent is freely given, utmost account shall be taken of whether, inter alia, the performance of a contract, including the provision of a service, is conditional on consent to the processing of personal data that is not necessary for the performance of that contract. Article 8 Conditions applicable to child's consent in relation to information society services 1. Where point (a) of Article 6(1) applies, in relation to the offer of information society services directly to a child, the processing of the personal data of a child shall be lawful where the child is at least 16 years old. Where the child is below the age of 16 years, such processing shall be lawful only if and to the extent that consent is given or authorised by the holder of parental responsibility over the child. Member States may provide by law for a lower age for those purposes provided that such lower age is not below 13 years. 2. The controller shall make reasonable efforts to verify in such cases that consent is given or authorised by the holder of parental responsibility over the child, taking into consideration available technology. 3. Paragraph 1 shall not affect the general contract law of Member States such as the rules on the validity, formation or effect of a contract in relation to a child. Article 9 Processing of special categories of personal data 1. Processing of personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person's sex life or sexual orientation shall be prohibited. 2. Paragraph 1 shall not apply if one of the following applies: (a) the data subject has given explicit consent to the processing of those personal data for one or more specified purposes, except where Union or Member State law provide that the prohibition referred to in paragraph 1 may not be lifted by the data subject; (b) processing is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller or of the data subject in the field of employment and social security and social protection law in so far as it is authorised by Union or Member State law or a collective agreement pursuant to Member State law providing for appropriate safeguards for the fundamental rights and the interests of the data subject; (c) processing is necessary to protect the vital interests of the data subject or of another natural person where the data subject is physically or legally incapable of giving consent; (d) processing is carried out in the course of its legitimate activities with appropriate safeguards by a foundation, association or any other not-for-profit body with a political, philosophical, religious or trade union aim and on condition that the processing relates solely to the members or to former members of the body or to persons who have regular contact with it in connection with its purposes and that the personal data are not disclosed outside that body without the consent of the data subjects; (e) processing relates to personal data which are manifestly made public by the data subject; (f) processing is necessary for the establishment, exercise or defence of legal claims or whenever courts are acting in their judicial capacity; (g) processing is necessary for reasons of substantial public interest, on the basis of Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject; (h) processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3; (i) processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy; (j) processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. 3. Personal data referred to in paragraph 1 may be processed for the purposes referred to in point (h) of paragraph 2 when those data are processed by or under the responsibility of a professional subject to the obligation of professional secrecy under Union or Member State law or rules established by national competent bodies or by another person also subject to an obligation of secrecy under Union or Member State law or rules established by national competent bodies. 4. Member States may maintain or introduce further conditions, including limitations, with regard to the processing of genetic data, biometric data or data concerning health. Article 10 Processing of personal data relating to criminal convictions and offences Processing of personal data relating to criminal convictions and offences or related security measures based on Article 6(1) shall be carried out only under the control of official authority or when the processing is authorised by Union or Member State law providing for appropriate safeguards for the rights and freedoms of data subjects. Any comprehensive register of criminal convictions shall be kept only under the control of official authority. Article 11 Processing which does not require identification 1. If the purposes for which a controller processes personal data do not or do no longer require the identification of a data subject by the controller, the controller shall not be obliged to maintain, acquire or process additional information in order to identify the data subject for the sole purpose of complying with this Regulation. 2. Where, in cases referred to in paragraph 1 of this Article, the controller is able to demonstrate that it is not in a position to identify the data subject, the controller shall inform the data subject accordingly, if possible. In such cases, Articles 15 to 20 shall not apply except where the data subject, for the purpose of exercising his or her rights under those articles, provides additional information enabling his or her identification. CHAPTER III Rights of the data subject Section 1 Transparency and modalities Article 12 Transparent information, communication and modalities for the exercise of the rights of the data subject 1. The controller shall take appropriate measures to provide any information referred to in Articles 13 and 14 and any communication under Articles 15 to 22 and 34 relating to processing to the data subject in a concise, transparent, intelligible and easily accessible form, using clear and plain language, in particular for any information addressed specifically to a child. The information shall be provided in writing, or by other means, including, where appropriate, by electronic means. When requested by the data subject, the information may be provided orally, provided that the identity of the data subject is proven by other means. 2. The controller shall facilitate the exercise of data subject rights under Articles 15 to 22. In the cases referred to in Article 11(2), the controller shall not refuse to act on the request of the data subject for exercising his or her rights under Articles 15 to 22, unless the controller demonstrates that it is not in a position to identify the data subject. 3. The controller shall provide information on action taken on a request under Articles 15 to 22 to the data subject without undue delay and in any event within one month of receipt of the request. That period may be extended by two further months where necessary, taking into account the complexity and number of the requests. The controller shall inform the data subject of any such extension within one month of receipt of the request, together with the reasons for the delay. Where the data subject makes the request by electronic form means, the information shall be provided by electronic means where possible, unless otherwise requested by the data subject. 4. If the controller does not take action on the request of the data subject, the controller shall inform the data subject without delay and at the latest within one month of receipt of the request of the reasons for not taking action and on the possibility of lodging a complaint with a supervisory authority and seeking a judicial remedy. 5. Information provided under Articles 13 and 14 and any communication and any actions taken under Articles 15 to 22 and 34 shall be provided free of charge. Where requests from a data subject are manifestly unfounded or excessive, in particular because of their repetitive character, the controller may either: (a) charge a reasonable fee taking into account the administrative costs of providing the information or communication or taking the action requested; or (b) refuse to act on the request. The controller shall bear the burden of demonstrating the manifestly unfounded or excessive character of the request. 6. Without prejudice to Article 11, where the controller has reasonable doubts concerning the identity of the natural person making the request referred to in Articles 15 to 21, the controller may request the provision of additional information necessary to confirm the identity of the data subject. 7. The information to be provided to data subjects pursuant to Articles 13 and 14 may be provided in combination with standardised icons in order to give in an easily visible, intelligible and clearly legible manner a meaningful overview of the intended processing. Where the icons are presented electronically they shall be machine-readable. 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 92 for the purpose of determining the information to be presented by the icons and the procedures for providing standardised icons. Section 2 Information and access to personal data Article 13 Information to be provided where personal data are collected from the data subject 1. Where personal data relating to a data subject are collected from the data subject, the controller shall, at the time when personal data are obtained, provide the data subject with all of the following information: (a) the identity and the contact details of the controller and, where applicable, of the controller's representative; (b) the contact details of the data protection officer, where applicable; (c) the purposes of the processing for which the personal data are intended as well as the legal basis for the processing; (d) where the processing is based on point (f) of Article 6(1), the legitimate interests pursued by the controller or by a third party; (e) the recipients or categories of recipients of the personal data, if any; (f) where applicable, the fact that the controller intends to transfer personal data to a third country or international organisation and the existence or absence of an adequacy decision by the Commission, or in the case of transfers referred to in Article 46 or 47, or the second subparagraph of Article 49(1), reference to the appropriate or suitable safeguards and the means by which to obtain a copy of them or where they have been made available. 2. In addition to the information referred to in paragraph 1, the controller shall, at the time when personal data are obtained, provide the data subject with the following further information necessary to ensure fair and transparent processing: (a) the period for which the personal data will be stored, or if that is not possible, the criteria used to determine that period; (b) the existence of the right to request from the controller access to and rectification or erasure of personal data or restriction of processing concerning the data subject or to object to processing as well as the right to data portability; (c) where the processing is based on point (a) of Article 6(1) or point (a) of Article 9(2), the existence of the right to withdraw consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal; (d) the right to lodge a complaint with a supervisory authority; (e) whether the provision of personal data is a statutory or contractual requirement, or a requirement necessary to enter into a contract, as well as whether the data subject is obliged to provide the personal data and of the possible consequences of failure to provide such data; (f) the existence of automated decision-making, including profiling, referred to in Article 22(1) and (4) and, at least in those cases, meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing for the data subject. 3. Where the controller intends to further process the personal data for a purpose other than that for which the personal data were collected, the controller shall provide the data subject prior to that further processing with information on that other purpose and with any relevant further information as referred to in paragraph 2. 4. Paragraphs 1, 2 and 3 shall not apply where and insofar as the data subject already has the information. Article 14 Information to be provided where personal data have not been obtained from the data subject 1. Where personal data have not been obtained from the data subject, the controller shall provide the data subject with the following information: (a) the identity and the contact details of the controller and, where applicable, of the controller's representative; (b) the contact details of the data protection officer, where applicable; (c) the purposes of the processing for which the personal data are intended as well as the legal basis for the processing; (d) the categories of personal data concerned; (e) the recipients or categories of recipients of the personal data, if any; (f) where applicable, that the controller intends to transfer personal data to a recipient in a third country or international organisation and the existence or absence of an adequacy decision by the Commission, or in the case of transfers referred to in Article 46 or 47, or the second subparagraph of Article 49(1), reference to the appropriate or suitable safeguards and the means to obtain a copy of them or where they have been made available. 2. In addition to the information referred to in paragraph 1, the controller shall provide the data subject with the following information necessary to ensure fair and transparent processing in respect of the data subject: (a) the period for which the personal data will be stored, or if that is not possible, the criteria used to determine that period; (b) where the processing is based on point (f) of Article 6(1), the legitimate interests pursued by the controller or by a third party; (c) the existence of the right to request from the controller access to and rectification or erasure of personal data or restriction of processing concerning the data subject and to object to processing as well as the right to data portability; (d) where processing is based on point (a) of Article 6(1) or point (a) of Article 9(2), the existence of the right to withdraw consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal; (e) the right to lodge a complaint with a supervisory authority; (f) from which source the personal data originate, and if applicable, whether it came from publicly accessible sources; (g) the existence of automated decision-making, including profiling, referred to in Article 22(1) and (4) and, at least in those cases, meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing for the data subject. 3. The controller shall provide the information referred to in paragraphs 1 and 2: (a) within a reasonable period after obtaining the personal data, but at the latest within one month, having regard to the specific circumstances in which the personal data are processed; (b) if the personal data are to be used for communication with the data subject, at the latest at the time of the first communication to that data subject; or (c) if a disclosure to another recipient is envisaged, at the latest when the personal data are first disclosed. 4. Where the controller intends to further process the personal data for a purpose other than that for which the personal data were obtained, the controller shall provide the data subject prior to that further processing with information on that other purpose and with any relevant further information as referred to in paragraph 2. 5. Paragraphs 1 to 4 shall not apply where and insofar as: (a) the data subject already has the information; (b) the provision of such information proves impossible or would involve a disproportionate effort, in particular for processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, subject to the conditions and safeguards referred to in Article 89(1) or in so far as the obligation referred to in paragraph 1 of this Article is likely to render impossible or seriously impair the achievement of the objectives of that processing. In such cases the controller shall take appropriate measures to protect the data subject's rights and freedoms and legitimate interests, including making the information publicly available; (c) obtaining or disclosure is expressly laid down by Union or Member State law to which the controller is subject and which provides appropriate measures to protect the data subject's legitimate interests; or (d) where the personal data must remain confidential subject to an obligation of professional secrecy regulated by Union or Member State law, including a statutory obligation of secrecy. Article 15 Right of access by the data subject 1. The data subject shall have the right to obtain from the controller confirmation as to whether or not personal data concerning him or her are being processed, and, where that is the case, access to the personal data and the following information: (a) the purposes of the processing; (b) the categories of personal data concerned; (c) the recipients or categories of recipient to whom the personal data have been or will be disclosed, in particular recipients in third countries or international organisations; (d) where possible, the envisaged period for which the personal data will be stored, or, if not possible, the criteria used to determine that period; (e) the existence of the right to request from the controller rectification or erasure of personal data or restriction of processing of personal data concerning the data subject or to object to such processing; (f) the right to lodge a complaint with a supervisory authority; (g) where the personal data are not collected from the data subject, any available information as to their source; (h) the existence of automated decision-making, including profiling, referred to in Article 22(1) and (4) and, at least in those cases, meaningful information about the logic involved, as well as the significance and the envisaged consequences of such processing for the data subject. 2. Where personal data are transferred to a third country or to an international organisation, the data subject shall have the right to be informed of the appropriate safeguards pursuant to Article 46 relating to the transfer. 3. The controller shall provide a copy of the personal data undergoing processing. For any further copies requested by the data subject, the controller may charge a reasonable fee based on administrative costs. Where the data subject makes the request by electronic means, and unless otherwise requested by the data subject, the information shall be provided in a commonly used electronic form. 4. The right to obtain a copy referred to in paragraph 3 shall not adversely affect the rights and freedoms of others. Section 3 Rectification and erasure Article 16 Right to rectification The data subject shall have the right to obtain from the controller without undue delay the rectification of inaccurate personal data concerning him or her. Taking into account the purposes of the processing, the data subject shall have the right to have incomplete personal data completed, including by means of providing a supplementary statement. Article 17 Right to erasure (‘right to be forgotten’) 1. The data subject shall have the right to obtain from the controller the erasure of personal data concerning him or her without undue delay and the controller shall have the obligation to erase personal data without undue delay where one of the following grounds applies: (a) the personal data are no longer necessary in relation to the purposes for which they were collected or otherwise processed; (b) the data subject withdraws consent on which the processing is based according to point (a) of Article 6(1), or point (a) of Article 9(2), and where there is no other legal ground for the processing; (c) the data subject objects to the processing pursuant to Article 21(1) and there are no overriding legitimate grounds for the processing, or the data subject objects to the processing pursuant to Article 21(2); (d) the personal data have been unlawfully processed; (e) the personal data have to be erased for compliance with a legal obligation in Union or Member State law to which the controller is subject; (f) the personal data have been collected in relation to the offer of information society services referred to in Article 8(1). 2. Where the controller has made the personal data public and is obliged pursuant to paragraph 1 to erase the personal data, the controller, taking account of available technology and the cost of implementation, shall take reasonable steps, including technical measures, to inform controllers which are processing the personal data that the data subject has requested the erasure by such controllers of any links to, or copy or replication of, those personal data. 3. Paragraphs 1 and 2 shall not apply to the extent that processing is necessary: (a) for exercising the right of freedom of expression and information; (b) for compliance with a legal obligation which requires processing by Union or Member State law to which the controller is subject or for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller; (c) for reasons of public interest in the area of public health in accordance with points (h) and (i) of Article 9(2) as well as Article 9(3); (d) for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) in so far as the right referred to in paragraph 1 is likely to render impossible or seriously impair the achievement of the objectives of that processing; or (e) for the establishment, exercise or defence of legal claims. Article 18 Right to restriction of processing 1. The data subject shall have the right to obtain from the controller restriction of processing where one of the following applies: (a) the accuracy of the personal data is contested by the data subject, for a period enabling the controller to verify the accuracy of the personal data; (b) the processing is unlawful and the data subject opposes the erasure of the personal data and requests the restriction of their use instead; (c) the controller no longer needs the personal data for the purposes of the processing, but they are required by the data subject for the establishment, exercise or defence of legal claims; (d) the data subject has objected to processing pursuant to Article 21(1) pending the verification whether the legitimate grounds of the controller override those of the data subject. 2. Where processing has been restricted under paragraph 1, such personal data shall, with the exception of storage, only be processed with the data subject's consent or for the establishment, exercise or defence of legal claims or for the protection of the rights of another natural or legal person or for reasons of important public interest of the Union or of a Member State. 3. A data subject who has obtained restriction of processing pursuant to paragraph 1 shall be informed by the controller before the restriction of processing is lifted. Article 19 Notification obligation regarding rectification or erasure of personal data or restriction of processing The controller shall communicate any rectification or erasure of personal data or restriction of processing carried out in accordance with Article 16, Article 17(1) and Article 18 to each recipient to whom the personal data have been disclosed, unless this proves impossible or involves disproportionate effort. The controller shall inform the data subject about those recipients if the data subject requests it. Article 20 Right to data portability 1. The data subject shall have the right to receive the personal data concerning him or her, which he or she has provided to a controller, in a structured, commonly used and machine-readable format and have the right to transmit those data to another controller without hindrance from the controller to which the personal data have been provided, where: (a) the processing is based on consent pursuant to point (a) of Article 6(1) or point (a) of Article 9(2) or on a contract pursuant to point (b) of Article 6(1); and (b) the processing is carried out by automated means. 2. In exercising his or her right to data portability pursuant to paragraph 1, the data subject shall have the right to have the personal data transmitted directly from one controller to another, where technically feasible. 3. The exercise of the right referred to in paragraph 1 of this Article shall be without prejudice to Article 17. That right shall not apply to processing necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. 4. The right referred to in paragraph 1 shall not adversely affect the rights and freedoms of others. Section 4 Right to object and automated individual decision-making Article 21 Right to object 1. The data subject shall have the right to object, on grounds relating to his or her particular situation, at any time to processing of personal data concerning him or her which is based on point (e) or (f) of Article 6(1), including profiling based on those provisions. The controller shall no longer process the personal data unless the controller demonstrates compelling legitimate grounds for the processing which override the interests, rights and freedoms of the data subject or for the establishment, exercise or defence of legal claims. 2. Where personal data are processed for direct marketing purposes, the data subject shall have the right to object at any time to processing of personal data concerning him or her for such marketing, which includes profiling to the extent that it is related to such direct marketing. 3. Where the data subject objects to processing for direct marketing purposes, the personal data shall no longer be processed for such purposes. 4. At the latest at the time of the first communication with the data subject, the right referred to in paragraphs 1 and 2 shall be explicitly brought to the attention of the data subject and shall be presented clearly and separately from any other information. 5. In the context of the use of information society services, and notwithstanding Directive 2002/58/EC, the data subject may exercise his or her right to object by automated means using technical specifications. 6. Where personal data are processed for scientific or historical research purposes or statistical purposes pursuant to Article 89(1), the data subject, on grounds relating to his or her particular situation, shall have the right to object to processing of personal data concerning him or her, unless the processing is necessary for the performance of a task carried out for reasons of public interest. Article 22 Automated individual decision-making, including profiling 1. The data subject shall have the right not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning him or her or similarly significantly affects him or her. 2. Paragraph 1 shall not apply if the decision: (a) is necessary for entering into, or performance of, a contract between the data subject and a data controller; (b) is authorised by Union or Member State law to which the controller is subject and which also lays down suitable measures to safeguard the data subject's rights and freedoms and legitimate interests; or (c) is based on the data subject's explicit consent. 3. In the cases referred to in points (a) and (c) of paragraph 2, the data controller shall implement suitable measures to safeguard the data subject's rights and freedoms and legitimate interests, at least the right to obtain human intervention on the part of the controller, to express his or her point of view and to contest the decision. 4. Decisions referred to in paragraph 2 shall not be based on special categories of personal data referred to in Article 9(1), unless point (a) or (g) of Article 9(2) applies and suitable measures to safeguard the data subject's rights and freedoms and legitimate interests are in place. Section 5 Restrictions Article 23 Restrictions 1. Union or Member State law to which the data controller or processor is subject may restrict by way of a legislative measure the scope of the obligations and rights provided for in Articles 12 to 22 and Article 34, as well as Article 5 in so far as its provisions correspond to the rights and obligations provided for in Articles 12 to 22, when such a restriction respects the essence of the fundamental rights and freedoms and is a necessary and proportionate measure in a democratic society to safeguard: (a) national security; (b) defence; (c) public security; (d) the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security; (e) other important objectives of general public interest of the Union or of a Member State, in particular an important economic or financial interest of the Union or of a Member State, including monetary, budgetary and taxation a matters, public health and social security; (f) the protection of judicial independence and judicial proceedings; (g) the prevention, investigation, detection and prosecution of breaches of ethics for regulated professions; (h) a monitoring, inspection or regulatory function connected, even occasionally, to the exercise of official authority in the cases referred to in points (a) to (e) and (g); (i) the protection of the data subject or the rights and freedoms of others; (j) the enforcement of civil law claims. 2. In particular, any legislative measure referred to in paragraph 1 shall contain specific provisions at least, where relevant, as to: (a) the purposes of the processing or categories of processing; (b) the categories of personal data; (c) the scope of the restrictions introduced; (d) the safeguards to prevent abuse or unlawful access or transfer; (e) the specification of the controller or categories of controllers; (f) the storage periods and the applicable safeguards taking into account the nature, scope and purposes of the processing or categories of processing; (g) the risks to the rights and freedoms of data subjects; and (h) the right of data subjects to be informed about the restriction, unless that may be prejudicial to the purpose of the restriction. CHAPTER IV Controller and processor Section 1 General obligations Article 24 Responsibility of the controller 1. Taking into account the nature, scope, context and purposes of processing as well as the risks of varying likelihood and severity for the rights and freedoms of natural persons, the controller shall implement appropriate technical and organisational measures to ensure and to be able to demonstrate that processing is performed in accordance with this Regulation. Those measures shall be reviewed and updated where necessary. 2. Where proportionate in relation to processing activities, the measures referred to in paragraph 1 shall include the implementation of appropriate data protection policies by the controller. 3. Adherence to approved codes of conduct as referred to in Article 40 or approved certification mechanisms as referred to in Article 42 may be used as an element by which to demonstrate compliance with the obligations of the controller. Article 25 Data protection by design and by default 1. Taking into account the state of the art, the cost of implementation and the nature, scope, context and purposes of processing as well as the risks of varying likelihood and severity for rights and freedoms of natural persons posed by the processing, the controller shall, both at the time of the determination of the means for processing and at the time of the processing itself, implement appropriate technical and organisational measures, such as pseudonymisation, which are designed to implement data-protection principles, such as data minimisation, in an effective manner and to integrate the necessary safeguards into the processing in order to meet the requirements of this Regulation and protect the rights of data subjects. 2. The controller shall implement appropriate technical and organisational measures for ensuring that, by default, only personal data which are necessary for each specific purpose of the processing are processed. That obligation applies to the amount of personal data collected, the extent of their processing, the period of their storage and their accessibility. In particular, such measures shall ensure that by default personal data are not made accessible without the individual's intervention to an indefinite number of natural persons. 3. An approved certification mechanism pursuant to Article 42 may be used as an element to demonstrate compliance with the requirements set out in paragraphs 1 and 2 of this Article. Article 26 Joint controllers 1. Where two or more controllers jointly determine the purposes and means of processing, they shall be joint controllers. They shall in a transparent manner determine their respective responsibilities for compliance with the obligations under this Regulation, in particular as regards the exercising of the rights of the data subject and their respective duties to provide the information referred to in Articles 13 and 14, by means of an arrangement between them unless, and in so far as, the respective responsibilities of the controllers are determined by Union or Member State law to which the controllers are subject. The arrangement may designate a contact point for data subjects. 2. The arrangement referred to in paragraph 1 shall duly reflect the respective roles and relationships of the joint controllers vis-à-vis the data subjects. The essence of the arrangement shall be made available to the data subject. 3. Irrespective of the terms of the arrangement referred to in paragraph 1, the data subject may exercise his or her rights under this Regulation in respect of and against each of the controllers. Article 27 Representatives of controllers or processors not established in the Union 1. Where Article 3(2) applies, the controller or the processor shall designate in writing a representative in the Union. 2. The obligation laid down in paragraph 1 of this Article shall not apply to: (a) processing which is occasional, does not include, on a large scale, processing of special categories of data as referred to in Article 9(1) or processing of personal data relating to criminal convictions and offences referred to in Article 10, and is unlikely to result in a risk to the rights and freedoms of natural persons, taking into account the nature, context, scope and purposes of the processing; or (b) a public authority or body. 3. The representative shall be established in one of the Member States where the data subjects, whose personal data are processed in relation to the offering of goods or services to them, or whose behaviour is monitored, are. 4. The representative shall be mandated by the controller or processor to be addressed in addition to or instead of the controller or the processor by, in particular, supervisory authorities and data subjects, on all issues related to processing, for the purposes of ensuring compliance with this Regulation. 5. The designation of a representative by the controller or processor shall be without prejudice to legal actions which could be initiated against the controller or the processor themselves. Article 28 Processor 1. Where processing is to be carried out on behalf of a controller, the controller shall use only processors providing sufficient guarantees to implement appropriate technical and organisational measures in such a manner that processing will meet the requirements of this Regulation and ensure the protection of the rights of the data subject. 2. The processor shall not engage another processor without prior specific or general written authorisation of the controller. In the case of general written authorisation, the processor shall inform the controller of any intended changes concerning the addition or replacement of other processors, thereby giving the controller the opportunity to object to such changes. 3. Processing by a processor shall be governed by a contract or other legal act under Union or Member State law, that is binding on the processor with regard to the controller and that sets out the subject-matter and duration of the processing, the nature and purpose of the processing, the type of personal data and categories of data subjects and the obligations and rights of the controller. That contract or other legal act shall stipulate, in particular, that the processor: (a) processes the personal data only on documented instructions from the controller, including with regard to transfers of personal data to a third country or an international organisation, unless required to do so by Union or Member State law to which the processor is subject; in such a case, the processor shall inform the controller of that legal requirement before processing, unless that law prohibits such information on important grounds of public interest; (b) ensures that persons authorised to process the personal data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality; (c) takes all measures required pursuant to Article 32; (d) respects the conditions referred to in paragraphs 2 and 4 for engaging another processor; (e) taking into account the nature of the processing, assists the controller by appropriate technical and organisational measures, insofar as this is possible, for the fulfilment of the controller's obligation to respond to requests for exercising the data subject's rights laid down in Chapter III; (f) assists the controller in ensuring compliance with the obligations pursuant to Articles 32 to 36 taking into account the nature of processing and the information available to the processor; (g) at the choice of the controller, deletes or returns all the personal data to the controller after the end of the provision of services relating to processing, and deletes existing copies unless Union or Member State law requires storage of the personal data; (h) makes available to the controller all information necessary to demonstrate compliance with the obligations laid down in this Article and allow for and contribute to audits, including inspections, conducted by the controller or another auditor mandated by the controller. With regard to point (h) of the first subparagraph, the processor shall immediately inform the controller if, in its opinion, an instruction infringes this Regulation or other Union or Member State data protection provisions. 4. Where a processor engages another processor for carrying out specific processing activities on behalf of the controller, the same data protection obligations as set out in the contract or other legal act between the controller and the processor as referred to in paragraph 3 shall be imposed on that other processor by way of a contract or other legal act under Union or Member State law, in particular providing sufficient guarantees to implement appropriate technical and organisational measures in such a manner that the processing will meet the requirements of this Regulation. Where that other processor fails to fulfil its data protection obligations, the initial processor shall remain fully liable to the controller for the performance of that other processor's obligations. 5. Adherence of a processor to an approved code of conduct as referred to in Article 40 or an approved certification mechanism as referred to in Article 42 may be used as an element by which to demonstrate sufficient guarantees as referred to in paragraphs 1 and 4 of this Article. 6. Without prejudice to an individual contract between the controller and the processor, the contract or the other legal act referred to in paragraphs 3 and 4 of this Article may be based, in whole or in part, on standard contractual clauses referred to in paragraphs 7 and 8 of this Article, including when they are part of a certification granted to the controller or processor pursuant to Articles 42 and 43. 7. The Commission may lay down standard contractual clauses for the matters referred to in paragraph 3 and 4 of this Article and in accordance with the examination procedure referred to in Article 93(2). 8. A supervisory authority may adopt standard contractual clauses for the matters referred to in paragraph 3 and 4 of this Article and in accordance with the consistency mechanism referred to in Article 63. 9. The contract or the other legal act referred to in paragraphs 3 and 4 shall be in writing, including in electronic form. 10. Without prejudice to Articles 82, 83 and 84, if a processor infringes this Regulation by determining the purposes and means of processing, the processor shall be considered to be a controller in respect of that processing. Article 29 Processing under the authority of the controller or processor The processor and any person acting under the authority of the controller or of the processor, who has access to personal data, shall not process those data except on instructions from the controller, unless required to do so by Union or Member State law. Article 30 Records of processing activities 1. Each controller and, where applicable, the controller's representative, shall maintain a record of processing activities under its responsibility. That record shall contain all of the following information: (a) the name and contact details of the controller and, where applicable, the joint controller, the controller's representative and the data protection officer; (b) the purposes of the processing; (c) a description of the categories of data subjects and of the categories of personal data; (d) the categories of recipients to whom the personal data have been or will be disclosed including recipients in third countries or international organisations; (e) where applicable, transfers of personal data to a third country or an international organisation, including the identification of that third country or international organisation and, in the case of transfers referred to in the second subparagraph of Article 49(1), the documentation of suitable safeguards; (f) where possible, the envisaged time limits for erasure of the different categories of data; (g) where possible, a general description of the technical and organisational security measures referred to in Article 32(1). 2. Each processor and, where applicable, the processor's representative shall maintain a record of all categories of processing activities carried out on behalf of a controller, containing: (a) the name and contact details of the processor or processors and of each controller on behalf of which the processor is acting, and, where applicable, of the controller's or the processor's representative, and the data protection officer; (b) the categories of processing carried out on behalf of each controller; (c) where applicable, transfers of personal data to a third country or an international organisation, including the identification of that third country or international organisation and, in the case of transfers referred to in the second subparagraph of Article 49(1), the documentation of suitable safeguards; (d) where possible, a general description of the technical and organisational security measures referred to in Article 32(1). 3. The records referred to in paragraphs 1 and 2 shall be in writing, including in electronic form. 4. The controller or the processor and, where applicable, the controller's or the processor's representative, shall make the record available to the supervisory authority on request. 5. The obligations referred to in paragraphs 1 and 2 shall not apply to an enterprise or an organisation employing fewer than 250 persons unless the processing it carries out is likely to result in a risk to the rights and freedoms of data subjects, the processing is not occasional, or the processing includes special categories of data as referred to in Article 9(1) or personal data relating to criminal convictions and offences referred to in Article 10. Article 31 Cooperation with the supervisory authority The controller and the processor and, where applicable, their representatives, shall cooperate, on request, with the supervisory authority in the performance of its tasks. Section 2 Security of personal data Article 32 Security of processing 1. Taking into account the state of the art, the costs of implementation and the nature, scope, context and purposes of processing as well as the risk of varying likelihood and severity for the rights and freedoms of natural persons, the controller and the processor shall implement appropriate technical and organisational measures to ensure a level of security appropriate to the risk, including inter alia as appropriate: (a) the pseudonymisation and encryption of personal data; (b) the ability to ensure the ongoing confidentiality, integrity, availability and resilience of processing systems and services; (c) the ability to restore the availability and access to personal data in a timely manner in the event of a physical or technical incident; (d) a process for regularly testing, assessing and evaluating the effectiveness of technical and organisational measures for ensuring the security of the processing. 2. In assessing the appropriate level of security account shall be taken in particular of the risks that are presented by processing, in particular from accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to personal data transmitted, stored or otherwise processed. 3. Adherence to an approved code of conduct as referred to in Article 40 or an approved certification mechanism as referred to in Article 42 may be used as an element by which to demonstrate compliance with the requirements set out in paragraph 1 of this Article. 4. The controller and processor shall take steps to ensure that any natural person acting under the authority of the controller or the processor who has access to personal data does not process them except on instructions from the controller, unless he or she is required to do so by Union or Member State law. Article 33 Notification of a personal data breach to the supervisory authority 1. In the case of a personal data breach, the controller shall without undue delay and, where feasible, not later than 72 hours after having become aware of it, notify the personal data breach to the supervisory authority competent in accordance with Article 55, unless the personal data breach is unlikely to result in a risk to the rights and freedoms of natural persons. Where the notification to the supervisory authority is not made within 72 hours, it shall be accompanied by reasons for the delay. 2. The processor shall notify the controller without undue delay after becoming aware of a personal data breach. 3. The notification referred to in paragraph 1 shall at least: (a) describe the nature of the personal data breach including where possible, the categories and approximate number of data subjects concerned and the categories and approximate number of personal data records concerned; (b) communicate the name and contact details of the data protection officer or other contact point where more information can be obtained; (c) describe the likely consequences of the personal data breach; (d) describe the measures taken or proposed to be taken by the controller to address the personal data breach, including, where appropriate, measures to mitigate its possible adverse effects. 4. Where, and in so far as, it is not possible to provide the information at the same time, the information may be provided in phases without undue further delay. 5. The controller shall document any personal data breaches, comprising the facts relating to the personal data breach, its effects and the remedial action taken. That documentation shall enable the supervisory authority to verify compliance with this Article. Article 34 Communication of a personal data breach to the data subject 1. When the personal data breach is likely to result in a high risk to the rights and freedoms of natural persons, the controller shall communicate the personal data breach to the data subject without undue delay. 2. The communication to the data subject referred to in paragraph 1 of this Article shall describe in clear and plain language the nature of the personal data breach and contain at least the information and measures referred to in points (b), (c) and (d) of Article 33(3). 3. The communication to the data subject referred to in paragraph 1 shall not be required if any of the following conditions are met: (a) the controller has implemented appropriate technical and organisational protection measures, and those measures were applied to the personal data affected by the personal data breach, in particular those that render the personal data unintelligible to any person who is not authorised to access it, such as encryption; (b) the controller has taken subsequent measures which ensure that the high risk to the rights and freedoms of data subjects referred to in paragraph 1 is no longer likely to materialise; (c) it would involve disproportionate effort. In such a case, there shall instead be a public communication or similar measure whereby the data subjects are informed in an equally effective manner. 4. If the controller has not already communicated the personal data breach to the data subject, the supervisory authority, having considered the likelihood of the personal data breach resulting in a high risk, may require it to do so or may decide that any of the conditions referred to in paragraph 3 are met. Section 3 Data protection impact assessment and prior consultation Article 35 Data protection impact assessment 1. Where a type of processing in particular using new technologies, and taking into account the nature, scope, context and purposes of the processing, is likely to result in a high risk to the rights and freedoms of natural persons, the controller shall, prior to the processing, carry out an assessment of the impact of the envisaged processing operations on the protection of personal data. A single assessment may address a set of similar processing operations that present similar high risks. 2. The controller shall seek the advice of the data protection officer, where designated, when carrying out a data protection impact assessment. 3. A data protection impact assessment referred to in paragraph 1 shall in particular be required in the case of: (a) a systematic and extensive evaluation of personal aspects relating to natural persons which is based on automated processing, including profiling, and on which decisions are based that produce legal effects concerning the natural person or similarly significantly affect the natural person; (b) processing on a large scale of special categories of data referred to in Article 9(1), or of personal data relating to criminal convictions and offences referred to in Article 10; or (c) a systematic monitoring of a publicly accessible area on a large scale. 4. The supervisory authority shall establish and make public a list of the kind of processing operations which are subject to the requirement for a data protection impact assessment pursuant to paragraph 1. The supervisory authority shall communicate those lists to the Board referred to in Article 68. 5. The supervisory authority may also establish and make public a list of the kind of processing operations for which no data protection impact assessment is required. The supervisory authority shall communicate those lists to the Board. 6. Prior to the adoption of the lists referred to in paragraphs 4 and 5, the competent supervisory authority shall apply the consistency mechanism referred to in Article 63 where such lists involve processing activities which are related to the offering of goods or services to data subjects or to the monitoring of their behaviour in several Member States, or may substantially affect the free movement of personal data within the Union. 7. The assessment shall contain at least: (a) a systematic description of the envisaged processing operations and the purposes of the processing, including, where applicable, the legitimate interest pursued by the controller; (b) an assessment of the necessity and proportionality of the processing operations in relation to the purposes; (c) an assessment of the risks to the rights and freedoms of data subjects referred to in paragraph 1; and (d) the measures envisaged to address the risks, including safeguards, security measures and mechanisms to ensure the protection of personal data and to demonstrate compliance with this Regulation taking into account the rights and legitimate interests of data subjects and other persons concerned. 8. Compliance with approved codes of conduct referred to in Article 40 by the relevant controllers or processors shall be taken into due account in assessing the impact of the processing operations performed by such controllers or processors, in particular for the purposes of a data protection impact assessment. 9. Where appropriate, the controller shall seek the views of data subjects or their representatives on the intended processing, without prejudice to the protection of commercial or public interests or the security of processing operations. 10. Where processing pursuant to point (c) or (e) of Article 6(1) has a legal basis in Union law or in the law of the Member State to which the controller is subject, that law regulates the specific processing operation or set of operations in question, and a data protection impact assessment has already been carried out as part of a general impact assessment in the context of the adoption of that legal basis, paragraphs 1 to 7 shall not apply unless Member States deem it to be necessary to carry out such an assessment prior to processing activities. 11. Where necessary, the controller shall carry out a review to assess if processing is performed in accordance with the data protection impact assessment at least when there is a change of the risk represented by processing operations. Article 36 Prior consultation 1. The controller shall consult the supervisory authority prior to processing where a data protection impact assessment under Article 35 indicates that the processing would result in a high risk in the absence of measures taken by the controller to mitigate the risk. 2. Where the supervisory authority is of the opinion that the intended processing referred to in paragraph 1 would infringe this Regulation, in particular where the controller has insufficiently identified or mitigated the risk, the supervisory authority shall, within period of up to eight weeks of receipt of the request for consultation, provide written advice to the controller and, where applicable to the processor, and may use any of its powers referred to in Article 58. That period may be extended by six weeks, taking into account the complexity of the intended processing. The supervisory authority shall inform the controller and, where applicable, the processor, of any such extension within one month of receipt of the request for consultation together with the reasons for the delay. Those periods may be suspended until the supervisory authority has obtained information it has requested for the purposes of the consultation. 3. When consulting the supervisory authority pursuant to paragraph 1, the controller shall provide the supervisory authority with: (a) where applicable, the respective responsibilities of the controller, joint controllers and processors involved in the processing, in particular for processing within a group of undertakings; (b) the purposes and means of the intended processing; (c) the measures and safeguards provided to protect the rights and freedoms of data subjects pursuant to this Regulation; (d) where applicable, the contact details of the data protection officer; (e) the data protection impact assessment provided for in Article 35; and (f) any other information requested by the supervisory authority. 4. Member States shall consult the supervisory authority during the preparation of a proposal for a legislative measure to be adopted by a national parliament, or of a regulatory measure based on such a legislative measure, which relates to processing. 5. Notwithstanding paragraph 1, Member State law may require controllers to consult with, and obtain prior authorisation from, the supervisory authority in relation to processing by a controller for the performance of a task carried out by the controller in the public interest, including processing in relation to social protection and public health. Section 4 Data protection officer Article 37 Designation of the data protection officer 1. The controller and the processor shall designate a data protection officer in any case where: (a) the processing is carried out by a public authority or body, except for courts acting in their judicial capacity; (b) the core activities of the controller or the processor consist of processing operations which, by virtue of their nature, their scope and/or their purposes, require regular and systematic monitoring of data subjects on a large scale; or (c) the core activities of the controller or the processor consist of processing on a large scale of special categories of data pursuant to Article 9 and personal data relating to criminal convictions and offences referred to in Article 10. 2. A group of undertakings may appoint a single data protection officer provided that a data protection officer is easily accessible from each establishment. 3. Where the controller or the processor is a public authority or body, a single data protection officer may be designated for several such authorities or bodies, taking account of their organisational structure and size. 4. In cases other than those referred to in paragraph 1, the controller or processor or associations and other bodies representing categories of controllers or processors may or, where required by Union or Member State law shall, designate a data protection officer. The data protection officer may act for such associations and other bodies representing controllers or processors. 5. The data protection officer shall be designated on the basis of professional qualities and, in particular, expert knowledge of data protection law and practices and the ability to fulfil the tasks referred to in Article 39. 6. The data protection officer may be a staff member of the controller or processor, or fulfil the tasks on the basis of a service contract. 7. The controller or the processor shall publish the contact details of the data protection officer and communicate them to the supervisory authority. Article 38 Position of the data protection officer 1. The controller and the processor shall ensure that the data protection officer is involved, properly and in a timely manner, in all issues which relate to the protection of personal data. 2. The controller and processor shall support the data protection officer in performing the tasks referred to in Article 39 by providing resources necessary to carry out those tasks and access to personal data and processing operations, and to maintain his or her expert knowledge. 3. The controller and processor shall ensure that the data protection officer does not receive any instructions regarding the exercise of those tasks. He or she shall not be dismissed or penalised by the controller or the processor for performing his tasks. The data protection officer shall directly report to the highest management level of the controller or the processor. 4. Data subjects may contact the data protection officer with regard to all issues related to processing of their personal data and to the exercise of their rights under this Regulation. 5. The data protection officer shall be bound by secrecy or confidentiality concerning the performance of his or her tasks, in accordance with Union or Member State law. 6. The data protection officer may fulfil other tasks and duties. The controller or processor shall ensure that any such tasks and duties do not result in a conflict of interests. Article 39 Tasks of the data protection officer 1. The data protection officer shall have at least the following tasks: (a) to inform and advise the controller or the processor and the employees who carry out processing of their obligations pursuant to this Regulation and to other Union or Member State data protection provisions; (b) to monitor compliance with this Regulation, with other Union or Member State data protection provisions and with the policies of the controller or processor in relation to the protection of personal data, including the assignment of responsibilities, awareness-raising and training of staff involved in processing operations, and the related audits; (c) to provide advice where requested as regards the data protection impact assessment and monitor its performance pursuant to Article 35; (d) to cooperate with the supervisory authority; (e) to act as the contact point for the supervisory authority on issues relating to processing, including the prior consultation referred to in Article 36, and to consult, where appropriate, with regard to any other matter. 2. The data protection officer shall in the performance of his or her tasks have due regard to the risk associated with processing operations, taking into account the nature, scope, context and purposes of processing. Section 5 Codes of conduct and certification Article 40 Codes of conduct 1. The Member States, the supervisory authorities, the Board and the Commission shall encourage the drawing up of codes of conduct intended to contribute to the proper application of this Regulation, taking account of the specific features of the various processing sectors and the specific needs of micro, small and medium-sized enterprises. 2. Associations and other bodies representing categories of controllers or processors may prepare codes of conduct, or amend or extend such codes, for the purpose of specifying the application of this Regulation, such as with regard to: (a) fair and transparent processing; (b) the legitimate interests pursued by controllers in specific contexts; (c) the collection of personal data; (d) the pseudonymisation of personal data; (e) the information provided to the public and to data subjects; (f) the exercise of the rights of data subjects; (g) the information provided to, and the protection of, children, and the manner in which the consent of the holders of parental responsibility over children is to be obtained; (h) the measures and procedures referred to in Articles 24 and 25 and the measures to ensure security of processing referred to in Article 32; (i) the notification of personal data breaches to supervisory authorities and the communication of such personal data breaches to data subjects; (j) the transfer of personal data to third countries or international organisations; or (k) out-of-court proceedings and other dispute resolution procedures for resolving disputes between controllers and data subjects with regard to processing, without prejudice to the rights of data subjects pursuant to Articles 77 and 79. 3. In addition to adherence by controllers or processors subject to this Regulation, codes of conduct approved pursuant to paragraph 5 of this Article and having general validity pursuant to paragraph 9 of this Article may also be adhered to by controllers or processors that are not subject to this Regulation pursuant to Article 3 in order to provide appropriate safeguards within the framework of personal data transfers to third countries or international organisations under the terms referred to in point (e) of Article 46(2). Such controllers or processors shall make binding and enforceable commitments, via contractual or other legally binding instruments, to apply those appropriate safeguards including with regard to the rights of data subjects. 4. A code of conduct referred to in paragraph 2 of this Article shall contain mechanisms which enable the body referred to in Article 41(1) to carry out the mandatory monitoring of compliance with its provisions by the controllers or processors which undertake to apply it, without prejudice to the tasks and powers of supervisory authorities competent pursuant to Article 55 or 56. 5. Associations and other bodies referred to in paragraph 2 of this Article which intend to prepare a code of conduct or to amend or extend an existing code shall submit the draft code, amendment or extension to the supervisory authority which is competent pursuant to Article 55. The supervisory authority shall provide an opinion on whether the draft code, amendment or extension complies with this Regulation and shall approve that draft code, amendment or extension if it finds that it provides sufficient appropriate safeguards. 6. Where the draft code, or amendment or extension is approved in accordance with paragraph 5, and where the code of conduct concerned does not relate to processing activities in several Member States, the supervisory authority shall register and publish the code. 7. Where a draft code of conduct relates to processing activities in several Member States, the supervisory authority which is competent pursuant to Article 55 shall, before approving the draft code, amendment or extension, submit it in the procedure referred to in Article 63 to the Board which shall provide an opinion on whether the draft code, amendment or extension complies with this Regulation or, in the situation referred to in paragraph 3 of this Article, provides appropriate safeguards. 8. Where the opinion referred to in paragraph 7 confirms that the draft code, amendment or extension complies with this Regulation, or, in the situation referred to in paragraph 3, provides appropriate safeguards, the Board shall submit its opinion to the Commission. 9. The Commission may, by way of implementing acts, decide that the approved code of conduct, amendment or extension submitted to it pursuant to paragraph 8 of this Article have general validity within the Union. Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 93(2). 10. The Commission shall ensure appropriate publicity for the approved codes which have been decided as having general validity in accordance with paragraph 9. 11. The Board shall collate all approved codes of conduct, amendments and extensions in a register and shall make them publicly available by way of appropriate means. Article 41 Monitoring of approved codes of conduct 1. Without prejudice to the tasks and powers of the competent supervisory authority under Articles 57 and 58, the monitoring of compliance with a code of conduct pursuant to Article 40 may be carried out by a body which has an appropriate level of expertise in relation to the subject-matter of the code and is accredited for that purpose by the competent supervisory authority. 2. A body as referred to in paragraph 1 may be accredited to monitor compliance with a code of conduct where that body has: (a) demonstrated its independence and expertise in relation to the subject-matter of the code to the satisfaction of the competent supervisory authority; (b) established procedures which allow it to assess the eligibility of controllers and processors concerned to apply the code, to monitor their compliance with its provisions and to periodically review its operation; (c) established procedures and structures to handle complaints about infringements of the code or the manner in which the code has been, or is being, implemented by a controller or processor, and to make those procedures and structures transparent to data subjects and the public; and (d) demonstrated to the satisfaction of the competent supervisory authority that its tasks and duties do not result in a conflict of interests. 3. The competent supervisory authority shall submit the draft criteria for accreditation of a body as referred to in paragraph 1 of this Article to the Board pursuant to the consistency mechanism referred to in Article 63. 4. Without prejudice to the tasks and powers of the competent supervisory authority and the provisions of Chapter VIII, a body as referred to in paragraph 1 of this Article shall, subject to appropriate safeguards, take appropriate action in cases of infringement of the code by a controller or processor, including suspension or exclusion of the controller or processor concerned from the code. It shall inform the competent supervisory authority of such actions and the reasons for taking them. 5. The competent supervisory authority shall revoke the accreditation of a body as referred to in paragraph 1 if the conditions for accreditation are not, or are no longer, met or where actions taken by the body infringe this Regulation. 6. This Article shall not apply to processing carried out by public authorities and bodies. Article 42 Certification 1. The Member States, the supervisory authorities, the Board and the Commission shall encourage, in particular at Union level, the establishment of data protection certification mechanisms and of data protection seals and marks, for the purpose of demonstrating compliance with this Regulation of processing operations by controllers and processors. The specific needs of micro, small and medium-sized enterprises shall be taken into account. 2. In addition to adherence by controllers or processors subject to this Regulation, data protection certification mechanisms, seals or marks approved pursuant to paragraph 5 of this Article may be established for the purpose of demonstrating the existence of appropriate safeguards provided by controllers or processors that are not subject to this Regulation pursuant to Article 3 within the framework of personal data transfers to third countries or international organisations under the terms referred to in point (f) of Article 46(2). Such controllers or processors shall make binding and enforceable commitments, via contractual or other legally binding instruments, to apply those appropriate safeguards, including with regard to the rights of data subjects. 3. The certification shall be voluntary and available via a process that is transparent. 4. A certification pursuant to this Article does not reduce the responsibility of the controller or the processor for compliance with this Regulation and is without prejudice to the tasks and powers of the supervisory authorities which are competent pursuant to Article 55 or 56. 5. A certification pursuant to this Article shall be issued by the certification bodies referred to in Article 43 or by the competent supervisory authority, on the basis of criteria approved by that competent supervisory authority pursuant to Article 58(3) or by the Board pursuant to Article 63. Where the criteria are approved by the Board, this may result in a common certification, the European Data Protection Seal. 6. The controller or processor which submits its processing to the certification mechanism shall provide the certification body referred to in Article 43, or where applicable, the competent supervisory authority, with all information and access to its processing activities which are necessary to conduct the certification procedure. 7. Certification shall be issued to a controller or processor for a maximum period of three years and may be renewed, under the same conditions, provided that the relevant requirements continue to be met. Certification shall be withdrawn, as applicable, by the certification bodies referred to in Article 43 or by the competent supervisory authority where the requirements for the certification are not or are no longer met. 8. The Board shall collate all certification mechanisms and data protection seals and marks in a register and shall make them publicly available by any appropriate means. Article 43 Certification bodies 1. Without prejudice to the tasks and powers of the competent supervisory authority under Articles 57 and 58, certification bodies which have an appropriate level of expertise in relation to data protection shall, after informing the supervisory authority in order to allow it to exercise its powers pursuant to point (h) of Article 58(2) where necessary, issue and renew certification. Member States shall ensure that those certification bodies are accredited by one or both of the following: (a) the supervisory authority which is competent pursuant to Article 55 or 56; (b) the national accreditation body named in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council (20) in accordance with EN-ISO/IEC 17065/2012 and with the additional requirements established by the supervisory authority which is competent pursuant to Article 55 or 56. 2. Certification bodies referred to in paragraph 1 shall be accredited in accordance with that paragraph only where they have: (a) demonstrated their independence and expertise in relation to the subject-matter of the certification to the satisfaction of the competent supervisory authority; (b) undertaken to respect the criteria referred to in Article 42(5) and approved by the supervisory authority which is competent pursuant to Article 55 or 56 or by the Board pursuant to Article 63; (c) established procedures for the issuing, periodic review and withdrawal of data protection certification, seals and marks; (d) established procedures and structures to handle complaints about infringements of the certification or the manner in which the certification has been, or is being, implemented by the controller or processor, and to make those procedures and structures transparent to data subjects and the public; and (e) demonstrated, to the satisfaction of the competent supervisory authority, that their tasks and duties do not result in a conflict of interests. 3. The accreditation of certification bodies as referred to in paragraphs 1 and 2 of this Article shall take place on the basis of criteria approved by the supervisory authority which is competent pursuant to Article 55 or 56 or by the Board pursuant to Article 63. In the case of accreditation pursuant to point (b) of paragraph 1 of this Article, those requirements shall complement those envisaged in Regulation (EC) No 765/2008 and the technical rules that describe the methods and procedures of the certification bodies. 4. The certification bodies referred to in paragraph 1 shall be responsible for the proper assessment leading to the certification or the withdrawal of such certification without prejudice to the responsibility of the controller or processor for compliance with this Regulation. The accreditation shall be issued for a maximum period of five years and may be renewed on the same conditions provided that the certification body meets the requirements set out in this Article. 5. The certification bodies referred to in paragraph 1 shall provide the competent supervisory authorities with the reasons for granting or withdrawing the requested certification. 6. The requirements referred to in paragraph 3 of this Article and the criteria referred to in Article 42(5) shall be made public by the supervisory authority in an easily accessible form. The supervisory authorities shall also transmit those requirements and criteria to the Board. The Board shall collate all certification mechanisms and data protection seals in a register and shall make them publicly available by any appropriate means. 7. Without prejudice to Chapter VIII, the competent supervisory authority or the national accreditation body shall revoke an accreditation of a certification body pursuant to paragraph 1 of this Article where the conditions for the accreditation are not, or are no longer, met or where actions taken by a certification body infringe this Regulation. 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 92 for the purpose of specifying the requirements to be taken into account for the data protection certification mechanisms referred to in Article 42(1). 9. The Commission may adopt implementing acts laying down technical standards for certification mechanisms and data protection seals and marks, and mechanisms to promote and recognise those certification mechanisms, seals and marks. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2). CHAPTER V Transfers of personal data to third countries or international organisations Article 44 General principle for transfers Any transfer of personal data which are undergoing processing or are intended for processing after transfer to a third country or to an international organisation shall take place only if, subject to the other provisions of this Regulation, the conditions laid down in this Chapter are complied with by the controller and processor, including for onward transfers of personal data from the third country or an international organisation to another third country or to another international organisation. All provisions in this Chapter shall be applied in order to ensure that the level of protection of natural persons guaranteed by this Regulation is not undermined. Article 45 Transfers on the basis of an adequacy decision 1. A transfer of personal data to a third country or an international organisation may take place where the Commission has decided that the third country, a territory or one or more specified sectors within that third country, or the international organisation in question ensures an adequate level of protection. Such a transfer shall not require any specific authorisation. 2. When assessing the adequacy of the level of protection, the Commission shall, in particular, take account of the following elements: (a) the rule of law, respect for human rights and fundamental freedoms, relevant legislation, both general and sectoral, including concerning public security, defence, national security and criminal law and the access of public authorities to personal data, as well as the implementation of such legislation, data protection rules, professional rules and security measures, including rules for the onward transfer of personal data to another third country or international organisation which are complied with in that country or international organisation, case-law, as well as effective and enforceable data subject rights and effective administrative and judicial redress for the data subjects whose personal data are being transferred; (b) the existence and effective functioning of one or more independent supervisory authorities in the third country or to which an international organisation is subject, with responsibility for ensuring and enforcing compliance with the data protection rules, including adequate enforcement powers, for assisting and advising the data subjects in exercising their rights and for cooperation with the supervisory authorities of the Member States; and (c) the international commitments the third country or international organisation concerned has entered into, or other obligations arising from legally binding conventions or instruments as well as from its participation in multilateral or regional systems, in particular in relation to the protection of personal data. 3. The Commission, after assessing the adequacy of the level of protection, may decide, by means of implementing act, that a third country, a territory or one or more specified sectors within a third country, or an international organisation ensures an adequate level of protection within the meaning of paragraph 2 of this Article. The implementing act shall provide for a mechanism for a periodic review, at least every four years, which shall take into account all relevant developments in the third country or international organisation. The implementing act shall specify its territorial and sectoral application and, where applicable, identify the supervisory authority or authorities referred to in point (b) of paragraph 2 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 93(2). 4. The Commission shall, on an ongoing basis, monitor developments in third countries and international organisations that could affect the functioning of decisions adopted pursuant to paragraph 3 of this Article and decisions adopted on the basis of Article 25(6) of Directive 95/46/EC. 5. The Commission shall, where available information reveals, in particular following the review referred to in paragraph 3 of this Article, that a third country, a territory or one or more specified sectors within a third country, or an international organisation no longer ensures an adequate level of protection within the meaning of paragraph 2 of this Article, to the extent necessary, repeal, amend or suspend the decision referred to in paragraph 3 of this Article by means of implementing acts without retro-active effect. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2). On duly justified imperative grounds of urgency, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 93(3). 6. The Commission shall enter into consultations with the third country or international organisation with a view to remedying the situation giving rise to the decision made pursuant to paragraph 5. 7. A decision pursuant to paragraph 5 of this Article is without prejudice to transfers of personal data to the third country, a territory or one or more specified sectors within that third country, or the international organisation in question pursuant to Articles 46 to 49. 8. The Commission shall publish in the Official Journal of the European Union and on its website a list of the third countries, territories and specified sectors within a third country and international organisations for which it has decided that an adequate level of protection is or is no longer ensured. 9. Decisions adopted by the Commission on the basis of Article 25(6) of Directive 95/46/EC shall remain in force until amended, replaced or repealed by a Commission Decision adopted in accordance with paragraph 3 or 5 of this Article. Article 46 Transfers subject to appropriate safeguards 1. In the absence of a decision pursuant to Article 45(3), a controller or processor may transfer personal data to a third country or an international organisation only if the controller or processor has provided appropriate safeguards, and on condition that enforceable data subject rights and effective legal remedies for data subjects are available. 2. The appropriate safeguards referred to in paragraph 1 may be provided for, without requiring any specific authorisation from a supervisory authority, by: (a) a legally binding and enforceable instrument between public authorities or bodies; (b) binding corporate rules in accordance with Article 47; (c) standard data protection clauses adopted by the Commission in accordance with the examination procedure referred to in Article 93(2); (d) standard data protection clauses adopted by a supervisory authority and approved by the Commission pursuant to the examination procedure referred to in Article 93(2); (e) an approved code of conduct pursuant to Article 40 together with binding and enforceable commitments of the controller or processor in the third country to apply the appropriate safeguards, including as regards data subjects' rights; or (f) an approved certification mechanism pursuant to Article 42 together with binding and enforceable commitments of the controller or processor in the third country to apply the appropriate safeguards, including as regards data subjects' rights. 3. Subject to the authorisation from the competent supervisory authority, the appropriate safeguards referred to in paragraph 1 may also be provided for, in particular, by: (a) contractual clauses between the controller or processor and the controller, processor or the recipient of the personal data in the third country or international organisation; or (b) provisions to be inserted into administrative arrangements between public authorities or bodies which include enforceable and effective data subject rights. 4. The supervisory authority shall apply the consistency mechanism referred to in Article 63 in the cases referred to in paragraph 3 of this Article. 5. Authorisations by a Member State or supervisory authority on the basis of Article 26(2) of Directive 95/46/EC shall remain valid until amended, replaced or repealed, if necessary, by that supervisory authority. Decisions adopted by the Commission on the basis of Article 26(4) of Directive 95/46/EC shall remain in force until amended, replaced or repealed, if necessary, by a Commission Decision adopted in accordance with paragraph 2 of this Article. Article 47 Binding corporate rules 1. The competent supervisory authority shall approve binding corporate rules in accordance with the consistency mechanism set out in Article 63, provided that they: (a) are legally binding and apply to and are enforced by every member concerned of the group of undertakings, or group of enterprises engaged in a joint economic activity, including their employees; (b) expressly confer enforceable rights on data subjects with regard to the processing of their personal data; and (c) fulfil the requirements laid down in paragraph 2. 2. The binding corporate rules referred to in paragraph 1 shall specify at least: (a) the structure and contact details of the group of undertakings, or group of enterprises engaged in a joint economic activity and of each of its members; (b) the data transfers or set of transfers, including the categories of personal data, the type of processing and its purposes, the type of data subjects affected and the identification of the third country or countries in question; (c) their legally binding nature, both internally and externally; (d) the application of the general data protection principles, in particular purpose limitation, data minimisation, limited storage periods, data quality, data protection by design and by default, legal basis for processing, processing of special categories of personal data, measures to ensure data security, and the requirements in respect of onward transfers to bodies not bound by the binding corporate rules; (e) the rights of data subjects in regard to processing and the means to exercise those rights, including the right not to be subject to decisions based solely on automated processing, including profiling in accordance with Article 22, the right to lodge a complaint with the competent supervisory authority and before the competent courts of the Member States in accordance with Article 79, and to obtain redress and, where appropriate, compensation for a breach of the binding corporate rules; (f) the acceptance by the controller or processor established on the territory of a Member State of liability for any breaches of the binding corporate rules by any member concerned not established in the Union; the controller or the processor shall be exempt from that liability, in whole or in part, only if it proves that that member is not responsible for the event giving rise to the damage; (g) how the information on the binding corporate rules, in particular on the provisions referred to in points (d), (e) and (f) of this paragraph is provided to the data subjects in addition to Articles 13 and 14; (h) the tasks of any data protection officer designated in accordance with Article 37 or any other person or entity in charge of the monitoring compliance with the binding corporate rules within the group of undertakings, or group of enterprises engaged in a joint economic activity, as well as monitoring training and complaint-handling; (i) the complaint procedures; (j) the mechanisms within the group of undertakings, or group of enterprises engaged in a joint economic activity for ensuring the verification of compliance with the binding corporate rules. Such mechanisms shall include data protection audits and methods for ensuring corrective actions to protect the rights of the data subject. Results of such verification should be communicated to the person or entity referred to in point (h) and to the board of the controlling undertaking of a group of undertakings, or of the group of enterprises engaged in a joint economic activity, and should be available upon request to the competent supervisory authority; (k) the mechanisms for reporting and recording changes to the rules and reporting those changes to the supervisory authority; (l) the cooperation mechanism with the supervisory authority to ensure compliance by any member of the group of undertakings, or group of enterprises engaged in a joint economic activity, in particular by making available to the supervisory authority the results of verifications of the measures referred to in point (j); (m) the mechanisms for reporting to the competent supervisory authority any legal requirements to which a member of the group of undertakings, or group of enterprises engaged in a joint economic activity is subject in a third country which are likely to have a substantial adverse effect on the guarantees provided by the binding corporate rules; and (n) the appropriate data protection training to personnel having permanent or regular access to personal data. 3. The Commission may specify the format and procedures for the exchange of information between controllers, processors and supervisory authorities for binding corporate rules within the meaning of this Article. Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 93(2). Article 48 Transfers or disclosures not authorised by Union law Any judgment of a court or tribunal and any decision of an administrative authority of a third country requiring a controller or processor to transfer or disclose personal data may only be recognised or enforceable in any manner if based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or a Member State, without prejudice to other grounds for transfer pursuant to this Chapter. Article 49 Derogations for specific situations 1. In the absence of an adequacy decision pursuant to Article 45(3), or of appropriate safeguards pursuant to Article 46, including binding corporate rules, a transfer or a set of transfers of personal data to a third country or an international organisation shall take place only on one of the following conditions: (a) the data subject has explicitly consented to the proposed transfer, after having been informed of the possible risks of such transfers for the data subject due to the absence of an adequacy decision and appropriate safeguards; (b) the transfer is necessary for the performance of a contract between the data subject and the controller or the implementation of pre-contractual measures taken at the data subject's request; (c) the transfer is necessary for the conclusion or performance of a contract concluded in the interest of the data subject between the controller and another natural or legal person; (d) the transfer is necessary for important reasons of public interest; (e) the transfer is necessary for the establishment, exercise or defence of legal claims; (f) the transfer is necessary in order to protect the vital interests of the data subject or of other persons, where the data subject is physically or legally incapable of giving consent; (g) the transfer is made from a register which according to Union or Member State law is intended to provide information to the public and which is open to consultation either by the public in general or by any person who can demonstrate a legitimate interest, but only to the extent that the conditions laid down by Union or Member State law for consultation are fulfilled in the particular case. Where a transfer could not be based on a provision in Article 45 or 46, including the provisions on binding corporate rules, and none of the derogations for a specific situation referred to in the first subparagraph of this paragraph is applicable, a transfer to a third country or an international organisation may take place only if the transfer is not repetitive, concerns only a limited number of data subjects, is necessary for the purposes of compelling legitimate interests pursued by the controller which are not overridden by the interests or rights and freedoms of the data subject, and the controller has assessed all the circumstances surrounding the data transfer and has on the basis of that assessment provided suitable safeguards with regard to the protection of personal data. The controller shall inform the supervisory authority of the transfer. The controller shall, in addition to providing the information referred to in Articles 13 and 14, inform the data subject of the transfer and on the compelling legitimate interests pursued. 2. A transfer pursuant to point (g) of the first subparagraph of paragraph 1 shall not involve the entirety of the personal data or entire categories of the personal data contained in the register. Where the register is intended for consultation by persons having a legitimate interest, the transfer shall be made only at the request of those persons or if they are to be the recipients. 3. Points (a), (b) and (c) of the first subparagraph of paragraph 1 and the second subparagraph thereof shall not apply to activities carried out by public authorities in the exercise of their public powers. 4. The public interest referred to in point (d) of the first subparagraph of paragraph 1 shall be recognised in Union law or in the law of the Member State to which the controller is subject. 5. In the absence of an adequacy decision, Union or Member State law may, for important reasons of public interest, expressly set limits to the transfer of specific categories of personal data to a third country or an international organisation. Member States shall notify such provisions to the Commission. 6. The controller or processor shall document the assessment as well as the suitable safeguards referred to in the second subparagraph of paragraph 1 of this Article in the records referred to in Article 30. Article 50 International cooperation for the protection of personal data In relation to third countries and international organisations, the Commission and supervisory authorities shall take appropriate steps to: (a) develop international cooperation mechanisms to facilitate the effective enforcement of legislation for the protection of personal data; (b) provide international mutual assistance in the enforcement of legislation for the protection of personal data, including through notification, complaint referral, investigative assistance and information exchange, subject to appropriate safeguards for the protection of personal data and other fundamental rights and freedoms; (c) engage relevant stakeholders in discussion and activities aimed at furthering international cooperation in the enforcement of legislation for the protection of personal data; (d) promote the exchange and documentation of personal data protection legislation and practice, including on jurisdictional conflicts with third countries. CHAPTER VI Independent supervisory authorities Section 1 Independent status Article 51 Supervisory authority 1. Each Member State shall provide for one or more independent public authorities to be responsible for monitoring the application of this Regulation, in order to protect the fundamental rights and freedoms of natural persons in relation to processing and to facilitate the free flow of personal data within the Union (‘supervisory authority’). 2. Each supervisory authority shall contribute to the consistent application of this Regulation throughout the Union. For that purpose, the supervisory authorities shall cooperate with each other and the Commission in accordance with Chapter VII. 3. Where more than one supervisory authority is established in a Member State, that Member State shall designate the supervisory authority which is to represent those authorities in the Board and shall set out the mechanism to ensure compliance by the other authorities with the rules relating to the consistency mechanism referred to in Article 63. 4. Each Member State shall notify to the Commission the provisions of its law which it adopts pursuant to this Chapter, by 25 May 2018 and, without delay, any subsequent amendment affecting them. Article 52 Independence 1. Each supervisory authority shall act with complete independence in performing its tasks and exercising its powers in accordance with this Regulation. 2. The member or members of each supervisory authority shall, in the performance of their tasks and exercise of their powers in accordance with this Regulation, remain free from external influence, whether direct or indirect, and shall neither seek nor take instructions from anybody. 3. Member or members of each supervisory authority shall refrain from any action incompatible with their duties and shall not, during their term of office, engage in any incompatible occupation, whether gainful or not. 4. Each Member State shall ensure that each supervisory authority is provided with the human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and exercise of its powers, including those to be carried out in the context of mutual assistance, cooperation and participation in the Board. 5. Each Member State shall ensure that each supervisory authority chooses and has its own staff which shall be subject to the exclusive direction of the member or members of the supervisory authority concerned. 6. Each Member State shall ensure that each supervisory authority is subject to financial control which does not affect its independence and that it has separate, public annual budgets, which may be part of the overall state or national budget. Article 53 General conditions for the members of the supervisory authority 1. Member States shall provide for each member of their supervisory authorities to be appointed by means of a transparent procedure by: — their parliament; — their government; — their head of State; or — an independent body entrusted with the appointment under Member State law. 2. Each member shall have the qualifications, experience and skills, in particular in the area of the protection of personal data, required to perform its duties and exercise its powers. 3. The duties of a member shall end in the event of the expiry of the term of office, resignation or compulsory retirement, in accordance with the law of the Member State concerned. 4. A member shall be dismissed only in cases of serious misconduct or if the member no longer fulfils the conditions required for the performance of the duties. Article 54 Rules on the establishment of the supervisory authority 1. Each Member State shall provide by law for all of the following: (a) the establishment of each supervisory authority; (b) the qualifications and eligibility conditions required to be appointed as member of each supervisory authority; (c) the rules and procedures for the appointment of the member or members of each supervisory authority; (d) the duration of the term of the member or members of each supervisory authority of no less than four years, except for the first appointment after 24 May 2016, part of which may take place for a shorter period where that is necessary to protect the independence of the supervisory authority by means of a staggered appointment procedure; (e) whether and, if so, for how many terms the member or members of each supervisory authority is eligible for reappointment; (f) the conditions governing the obligations of the member or members and staff of each supervisory authority, prohibitions on actions, occupations and benefits incompatible therewith during and after the term of office and rules governing the cessation of employment. 2. The member or members and the staff of each supervisory authority shall, in accordance with Union or Member State law, be subject to a duty of professional secrecy both during and after their term of office, with regard to any confidential information which has come to their knowledge in the course of the performance of their tasks or exercise of their powers. During their term of office, that duty of professional secrecy shall in particular apply to reporting by natural persons of infringements of this Regulation. Section 2 Competence, tasks and powers Article 55 Competence 1. Each supervisory authority shall be competent for the performance of the tasks assigned to and the exercise of the powers conferred on it in accordance with this Regulation on the territory of its own Member State. 2. Where processing is carried out by public authorities or private bodies acting on the basis of point (c) or (e) of Article 6(1), the supervisory authority of the Member State concerned shall be competent. In such cases Article 56 does not apply. 3. Supervisory authorities shall not be competent to supervise processing operations of courts acting in their judicial capacity. Article 56 Competence of the lead supervisory authority 1. Without prejudice to Article 55, the supervisory authority of the main establishment or of the single establishment of the controller or processor shall be competent to act as lead supervisory authority for the cross-border processing carried out by that controller or processor in accordance with the procedure provided in Article 60. 2. By derogation from paragraph 1, each supervisory authority shall be competent to handle a complaint lodged with it or a possible infringement of this Regulation, if the subject matter relates only to an establishment in its Member State or substantially affects data subjects only in its Member State. 3. In the cases referred to in paragraph 2 of this Article, the supervisory authority shall inform the lead supervisory authority without delay on that matter. Within a period of three weeks after being informed the lead supervisory authority shall decide whether or not it will handle the case in accordance with the procedure provided in Article 60, taking into account whether or not there is an establishment of the controller or processor in the Member State of which the supervisory authority informed it. 4. Where the lead supervisory authority decides to handle the case, the procedure provided in Article 60 shall apply. The supervisory authority which informed the lead supervisory authority may submit to the lead supervisory authority a draft for a decision. The lead supervisory authority shall take utmost account of that draft when preparing the draft decision referred to in Article 60(3). 5. Where the lead supervisory authority decides not to handle the case, the supervisory authority which informed the lead supervisory authority shall handle it according to Articles 61 and 62. 6. The lead supervisory authority shall be the sole interlocutor of the controller or processor for the cross-border processing carried out by that controller or processor. Article 57 Tasks 1. Without prejudice to other tasks set out under this Regulation, each supervisory authority shall on its territory: (a) monitor and enforce the application of this Regulation; (b) promote public awareness and understanding of the risks, rules, safeguards and rights in relation to processing. Activities addressed specifically to children shall receive specific attention; (c) advise, in accordance with Member State law, the national parliament, the government, and other institutions and bodies on legislative and administrative measures relating to the protection of natural persons' rights and freedoms with regard to processing; (d) promote the awareness of controllers and processors of their obligations under this Regulation; (e) upon request, provide information to any data subject concerning the exercise of their rights under this Regulation and, if appropriate, cooperate with the supervisory authorities in other Member States to that end; (f) handle complaints lodged by a data subject, or by a body, organisation or association in accordance with Article 80, and investigate, to the extent appropriate, the subject matter of the complaint and inform the complainant of the progress and the outcome of the investigation within a reasonable period, in particular if further investigation or coordination with another supervisory authority is necessary; (g) cooperate with, including sharing information and provide mutual assistance to, other supervisory authorities with a view to ensuring the consistency of application and enforcement of this Regulation; (h) conduct investigations on the application of this Regulation, including on the basis of information received from another supervisory authority or other public authority; (i) monitor relevant developments, insofar as they have an impact on the protection of personal data, in particular the development of information and communication technologies and commercial practices; (j) adopt standard contractual clauses referred to in Article 28(8) and in point (d) of Article 46(2); (k) establish and maintain a list in relation to the requirement for data protection impact assessment pursuant to Article 35(4); (l) give advice on the processing operations referred to in Article 36(2); (m) encourage the drawing up of codes of conduct pursuant to Article 40(1) and provide an opinion and approve such codes of conduct which provide sufficient safeguards, pursuant to Article 40(5); (n) encourage the establishment of data protection certification mechanisms and of data protection seals and marks pursuant to Article 42(1), and approve the criteria of certification pursuant to Article 42(5); (o) where applicable, carry out a periodic review of certifications issued in accordance with Article 42(7); (p) draft and publish the criteria for accreditation of a body for monitoring codes of conduct pursuant to Article 41 and of a certification body pursuant to Article 43; (q) conduct the accreditation of a body for monitoring codes of conduct pursuant to Article 41 and of a certification body pursuant to Article 43; (r) authorise contractual clauses and provisions referred to in Article 46(3); (s) approve binding corporate rules pursuant to Article 47; (t) contribute to the activities of the Board; (u) keep internal records of infringements of this Regulation and of measures taken in accordance with Article 58(2); and (v) fulfil any other tasks related to the protection of personal data. 2. Each supervisory authority shall facilitate the submission of complaints referred to in point (f) of paragraph 1 by measures such as a complaint submission form which can also be completed electronically, without excluding other means of communication. 3. The performance of the tasks of each supervisory authority shall be free of charge for the data subject and, where applicable, for the data protection officer. 4. Where requests are manifestly unfounded or excessive, in particular because of their repetitive character, the supervisory authority may charge a reasonable fee based on administrative costs, or refuse to act on the request. The supervisory authority shall bear the burden of demonstrating the manifestly unfounded or excessive character of the request. Article 58 Powers 1. Each supervisory authority shall have all of the following investigative powers: (a) to order the controller and the processor, and, where applicable, the controller's or the processor's representative to provide any information it requires for the performance of its tasks; (b) to carry out investigations in the form of data protection audits; (c) to carry out a review on certifications issued pursuant to Article 42(7); (d) to notify the controller or the processor of an alleged infringement of this Regulation; (e) to obtain, from the controller and the processor, access to all personal data and to all information necessary for the performance of its tasks; (f) to obtain access to any premises of the controller and the processor, including to any data processing equipment and means, in accordance with Union or Member State procedural law. 2. Each supervisory authority shall have all of the following corrective powers: (a) to issue warnings to a controller or processor that intended processing operations are likely to infringe provisions of this Regulation; (b) to issue reprimands to a controller or a processor where processing operations have infringed provisions of this Regulation; (c) to order the controller or the processor to comply with the data subject's requests to exercise his or her rights pursuant to this Regulation; (d) to order the controller or processor to bring processing operations into compliance with the provisions of this Regulation, where appropriate, in a specified manner and within a specified period; (e) to order the controller to communicate a personal data breach to the data subject; (f) to impose a temporary or definitive limitation including a ban on processing; (g) to order the rectification or erasure of personal data or restriction of processing pursuant to Articles 16, 17 and 18 and the notification of such actions to recipients to whom the personal data have been disclosed pursuant to Article 17(2) and Article 19; (h) to withdraw a certification or to order the certification body to withdraw a certification issued pursuant to Articles 42 and 43, or to order the certification body not to issue certification if the requirements for the certification are not or are no longer met; (i) to impose an administrative fine pursuant to Article 83, in addition to, or instead of measures referred to in this paragraph, depending on the circumstances of each individual case; (j) to order the suspension of data flows to a recipient in a third country or to an international organisation. 3. Each supervisory authority shall have all of the following authorisation and advisory powers: (a) to advise the controller in accordance with the prior consultation procedure referred to in Article 36; (b) to issue, on its own initiative or on request, opinions to the national parliament, the Member State government or, in accordance with Member State law, to other institutions and bodies as well as to the public on any issue related to the protection of personal data; (c) to authorise processing referred to in Article 36(5), if the law of the Member State requires such prior authorisation; (d) to issue an opinion and approve draft codes of conduct pursuant to Article 40(5); (e) to accredit certification bodies pursuant to Article 43; (f) to issue certifications and approve criteria of certification in accordance with Article 42(5); (g) to adopt standard data protection clauses referred to in Article 28(8) and in point (d) of Article 46(2); (h) to authorise contractual clauses referred to in point (a) of Article 46(3); (i) to authorise administrative arrangements referred to in point (b) of Article 46(3); (j) to approve binding corporate rules pursuant to Article 47. 4. The exercise of the powers conferred on the supervisory authority pursuant to this Article shall be subject to appropriate safeguards, including effective judicial remedy and due process, set out in Union and Member State law in accordance with the Charter. 5. Each Member State shall provide by law that its supervisory authority shall have the power to bring infringements of this Regulation to the attention of the judicial authorities and where appropriate, to commence or engage otherwise in legal proceedings, in order to enforce the provisions of this Regulation. 6. Each Member State may provide by law that its supervisory authority shall have additional powers to those referred to in paragraphs 1, 2 and 3. The exercise of those powers shall not impair the effective operation of Chapter VII. Article 59 Activity reports Each supervisory authority shall draw up an annual report on its activities, which may include a list of types of infringement notified and types of measures taken in accordance with Article 58(2). Those reports shall be transmitted to the national parliament, the government and other authorities as designated by Member State law. They shall be made available to the public, to the Commission and to the Board. CHAPTER VII Cooperation and consistency Section 1 Cooperation Article 60 Cooperation between the lead supervisory authority and the other supervisory authorities concerned 1. The lead supervisory authority shall cooperate with the other supervisory authorities concerned in accordance with this Article in an endeavour to reach consensus. The lead supervisory authority and the supervisory authorities concerned shall exchange all relevant information with each other. 2. The lead supervisory authority may request at any time other supervisory authorities concerned to provide mutual assistance pursuant to Article 61 and may conduct joint operations pursuant to Article 62, in particular for carrying out investigations or for monitoring the implementation of a measure concerning a controller or processor established in another Member State. 3. The lead supervisory authority shall, without delay, communicate the relevant information on the matter to the other supervisory authorities concerned. It shall without delay submit a draft decision to the other supervisory authorities concerned for their opinion and take due account of their views. 4. Where any of the other supervisory authorities concerned within a period of four weeks after having been consulted in accordance with paragraph 3 of this Article, expresses a relevant and reasoned objection to the draft decision, the lead supervisory authority shall, if it does not follow the relevant and reasoned objection or is of the opinion that the objection is not relevant or reasoned, submit the matter to the consistency mechanism referred to in Article 63. 5. Where the lead supervisory authority intends to follow the relevant and reasoned objection made, it shall submit to the other supervisory authorities concerned a revised draft decision for their opinion. That revised draft decision shall be subject to the procedure referred to in paragraph 4 within a period of two weeks. 6. Where none of the other supervisory authorities concerned has objected to the draft decision submitted by the lead supervisory authority within the period referred to in paragraphs 4 and 5, the lead supervisory authority and the supervisory authorities concerned shall be deemed to be in agreement with that draft decision and shall be bound by it. 7. The lead supervisory authority shall adopt and notify the decision to the main establishment or single establishment of the controller or processor, as the case may be and inform the other supervisory authorities concerned and the Board of the decision in question, including a summary of the relevant facts and grounds. The supervisory authority with which a complaint has been lodged shall inform the complainant on the decision. 8. By derogation from paragraph 7, where a complaint is dismissed or rejected, the supervisory authority with which the complaint was lodged shall adopt the decision and notify it to the complainant and shall inform the controller thereof. 9. Where the lead supervisory authority and the supervisory authorities concerned agree to dismiss or reject parts of a complaint and to act on other parts of that complaint, a separate decision shall be adopted for each of those parts of the matter. The lead supervisory authority shall adopt the decision for the part concerning actions in relation to the controller, shall notify it to the main establishment or single establishment of the controller or processor on the territory of its Member State and shall inform the complainant thereof, while the supervisory authority of the complainant shall adopt the decision for the part concerning dismissal or rejection of that complaint, and shall notify it to that complainant and shall inform the controller or processor thereof. 10. After being notified of the decision of the lead supervisory authority pursuant to paragraphs 7 and 9, the controller or processor shall take the necessary measures to ensure compliance with the decision as regards processing activities in the context of all its establishments in the Union. The controller or processor shall notify the measures taken for complying with the decision to the lead supervisory authority, which shall inform the other supervisory authorities concerned. 11. Where, in exceptional circumstances, a supervisory authority concerned has reasons to consider that there is an urgent need to act in order to protect the interests of data subjects, the urgency procedure referred to in Article 66 shall apply. 12. The lead supervisory authority and the other supervisory authorities concerned shall supply the information required under this Article to each other by electronic means, using a standardised format. Article 61 Mutual assistance 1. Supervisory authorities shall provide each other with relevant information and mutual assistance in order to implement and apply this Regulation in a consistent manner, and shall put in place measures for effective cooperation with one another. Mutual assistance shall cover, in particular, information requests and supervisory measures, such as requests to carry out prior authorisations and consultations, inspections and investigations. 2. Each supervisory authority shall take all appropriate measures required to reply to a request of another supervisory authority without undue delay and no later than one month after receiving the request. Such measures may include, in particular, the transmission of relevant information on the conduct of an investigation. 3. Requests for assistance shall contain all the necessary information, including the purpose of and reasons for the request. Information exchanged shall be used only for the purpose for which it was requested. 4. The requested supervisory authority shall not refuse to comply with the request unless: (a) it is not competent for the subject-matter of the request or for the measures it is requested to execute; or (b) compliance with the request would infringe this Regulation or Union or Member State law to which the supervisory authority receiving the request is subject. 5. The requested supervisory authority shall inform the requesting supervisory authority of the results or, as the case may be, of the progress of the measures taken in order to respond to the request. The requested supervisory authority shall provide reasons for any refusal to comply with a request pursuant to paragraph 4. 6. Requested supervisory authorities shall, as a rule, supply the information requested by other supervisory authorities by electronic means, using a standardised format. 7. Requested supervisory authorities shall not charge a fee for any action taken by them pursuant to a request for mutual assistance. Supervisory authorities may agree on rules to indemnify each other for specific expenditure arising from the provision of mutual assistance in exceptional circumstances. 8. Where a supervisory authority does not provide the information referred to in paragraph 5 of this Article within one month of receiving the request of another supervisory authority, the requesting supervisory authority may adopt a provisional measure on the territory of its Member State in accordance with Article 55(1). In that case, the urgent need to act under Article 66(1) shall be presumed to be met and require an urgent binding decision from the Board pursuant to Article 66(2). 9. The Commission may, by means of implementing acts, specify the format and procedures for mutual assistance referred to in this Article and the arrangements for the exchange of information by electronic means between supervisory authorities, and between supervisory authorities and the Board, in particular the standardised format referred to in paragraph 6 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2). Article 62 Joint operations of supervisory authorities 1. The supervisory authorities shall, where appropriate, conduct joint operations including joint investigations and joint enforcement measures in which members or staff of the supervisory authorities of other Member States are involved. 2. Where the controller or processor has establishments in several Member States or where a significant number of data subjects in more than one Member State are likely to be substantially affected by processing operations, a supervisory authority of each of those Member States shall have the right to participate in joint operations. The supervisory authority which is competent pursuant to Article 56(1) or (4) shall invite the supervisory authority of each of those Member States to take part in the joint operations and shall respond without delay to the request of a supervisory authority to participate. 3. A supervisory authority may, in accordance with Member State law, and with the seconding supervisory authority's authorisation, confer powers, including investigative powers on the seconding supervisory authority's members or staff involved in joint operations or, in so far as the law of the Member State of the host supervisory authority permits, allow the seconding supervisory authority's members or staff to exercise their investigative powers in accordance with the law of the Member State of the seconding supervisory authority. Such investigative powers may be exercised only under the guidance and in the presence of members or staff of the host supervisory authority. The seconding supervisory authority's members or staff shall be subject to the Member State law of the host supervisory authority. 4. Where, in accordance with paragraph 1, staff of a seconding supervisory authority operate in another Member State, the Member State of the host supervisory authority shall assume responsibility for their actions, including liability, for any damage caused by them during their operations, in accordance with the law of the Member State in whose territory they are operating. 5. The Member State in whose territory the damage was caused shall make good such damage under the conditions applicable to damage caused by its own staff. The Member State of the seconding supervisory authority whose staff has caused damage to any person in the territory of another Member State shall reimburse that other Member State in full any sums it has paid to the persons entitled on their behalf. 6. Without prejudice to the exercise of its rights vis-à-vis third parties and with the exception of paragraph 5, each Member State shall refrain, in the case provided for in paragraph 1, from requesting reimbursement from another Member State in relation to damage referred to in paragraph 4. 7. Where a joint operation is intended and a supervisory authority does not, within one month, comply with the obligation laid down in the second sentence of paragraph 2 of this Article, the other supervisory authorities may adopt a provisional measure on the territory of its Member State in accordance with Article 55. In that case, the urgent need to act under Article 66(1) shall be presumed to be met and require an opinion or an urgent binding decision from the Board pursuant to Article 66(2). Section 2 Consistency Article 63 Consistency mechanism In order to contribute to the consistent application of this Regulation throughout the Union, the supervisory authorities shall cooperate with each other and, where relevant, with the Commission, through the consistency mechanism as set out in this Section. Article 64 Opinion of the Board 1. The Board shall issue an opinion where a competent supervisory authority intends to adopt any of the measures below. To that end, the competent supervisory authority shall communicate the draft decision to the Board, when it: (a) aims to adopt a list of the processing operations subject to the requirement for a data protection impact assessment pursuant to Article 35(4); (b) concerns a matter pursuant to Article 40(7) whether a draft code of conduct or an amendment or extension to a code of conduct complies with this Regulation; (c) aims to approve the criteria for accreditation of a body pursuant to Article 41(3) or a certification body pursuant to Article 43(3); (d) aims to determine standard data protection clauses referred to in point (d) of Article 46(2) and in Article 28(8); (e) aims to authorise contractual clauses referred to in point (a) of Article 46(3); or (f) aims to approve binding corporate rules within the meaning of Article 47. 2. Any supervisory authority, the Chair of the Board or the Commission may request that any matter of general application or producing effects in more than one Member State be examined by the Board with a view to obtaining an opinion, in particular where a competent supervisory authority does not comply with the obligations for mutual assistance in accordance with Article 61 or for joint operations in accordance with Article 62. 3. In the cases referred to in paragraphs 1 and 2, the Board shall issue an opinion on the matter submitted to it provided that it has not already issued an opinion on the same matter. That opinion shall be adopted within eight weeks by simple majority of the members of the Board. That period may be extended by a further six weeks, taking into account the complexity of the subject matter. Regarding the draft decision referred to in paragraph 1 circulated to the members of the Board in accordance with paragraph 5, a member which has not objected within a reasonable period indicated by the Chair, shall be deemed to be in agreement with the draft decision. 4. Supervisory authorities and the Commission shall, without undue delay, communicate by electronic means to the Board, using a standardised format any relevant information, including as the case may be a summary of the facts, the draft decision, the grounds which make the enactment of such measure necessary, and the views of other supervisory authorities concerned. 5. The Chair of the Board shall, without undue, delay inform by electronic means: (a) the members of the Board and the Commission of any relevant information which has been communicated to it using a standardised format. The secretariat of the Board shall, where necessary, provide translations of relevant information; and (b) the supervisory authority referred to, as the case may be, in paragraphs 1 and 2, and the Commission of the opinion and make it public. 6. The competent supervisory authority shall not adopt its draft decision referred to in paragraph 1 within the period referred to in paragraph 3. 7. The supervisory authority referred to in paragraph 1 shall take utmost account of the opinion of the Board and shall, within two weeks after receiving the opinion, communicate to the Chair of the Board by electronic means whether it will maintain or amend its draft decision and, if any, the amended draft decision, using a standardised format. 8. Where the supervisory authority concerned informs the Chair of the Board within the period referred to in paragraph 7 of this Article that it does not intend to follow the opinion of the Board, in whole or in part, providing the relevant grounds, Article 65(1) shall apply. Article 65 Dispute resolution by the Board 1. In order to ensure the correct and consistent application of this Regulation in individual cases, the Board shall adopt a binding decision in the following cases: (a) where, in a case referred to in Article 60(4), a supervisory authority concerned has raised a relevant and reasoned objection to a draft decision of the lead authority or the lead authority has rejected such an objection as being not relevant or reasoned. The binding decision shall concern all the matters which are the subject of the relevant and reasoned objection, in particular whether there is an infringement of this Regulation; (b) where there are conflicting views on which of the supervisory authorities concerned is competent for the main establishment; (c) where a competent supervisory authority does not request the opinion of the Board in the cases referred to in Article 64(1), or does not follow the opinion of the Board issued under Article 64. In that case, any supervisory authority concerned or the Commission may communicate the matter to the Board. 2. The decision referred to in paragraph 1 shall be adopted within one month from the referral of the subject-matter by a two-thirds majority of the members of the Board. That period may be extended by a further month on account of the complexity of the subject-matter. The decision referred to in paragraph 1 shall be reasoned and addressed to the lead supervisory authority and all the supervisory authorities concerned and binding on them. 3. Where the Board has been unable to adopt a decision within the periods referred to in paragraph 2, it shall adopt its decision within two weeks following the expiration of the second month referred to in paragraph 2 by a simple majority of the members of the Board. Where the members of the Board are split, the decision shall by adopted by the vote of its Chair. 4. The supervisory authorities concerned shall not adopt a decision on the subject matter submitted to the Board under paragraph 1 during the periods referred to in paragraphs 2 and 3. 5. The Chair of the Board shall notify, without undue delay, the decision referred to in paragraph 1 to the supervisory authorities concerned. It shall inform the Commission thereof. The decision shall be published on the website of the Board without delay after the supervisory authority has notified the final decision referred to in paragraph 6. 6. The lead supervisory authority or, as the case may be, the supervisory authority with which the complaint has been lodged shall adopt its final decision on the basis of the decision referred to in paragraph 1 of this Article, without undue delay and at the latest by one month after the Board has notified its decision. The lead supervisory authority or, as the case may be, the supervisory authority with which the complaint has been lodged, shall inform the Board of the date when its final decision is notified respectively to the controller or the processor and to the data subject. The final decision of the supervisory authorities concerned shall be adopted under the terms of Article 60(7), (8) and (9). The final decision shall refer to the decision referred to in paragraph 1 of this Article and shall specify that the decision referred to in that paragraph will be published on the website of the Board in accordance with paragraph 5 of this Article. The final decision shall attach the decision referred to in paragraph 1 of this Article. Article 66 Urgency procedure 1. In exceptional circumstances, where a supervisory authority concerned considers that there is an urgent need to act in order to protect the rights and freedoms of data subjects, it may, by way of derogation from the consistency mechanism referred to in Articles 63, 64 and 65 or the procedure referred to in Article 60, immediately adopt provisional measures intended to produce legal effects on its own territory with a specified period of validity which shall not exceed three months. The supervisory authority shall, without delay, communicate those measures and the reasons for adopting them to the other supervisory authorities concerned, to the Board and to the Commission. 2. Where a supervisory authority has taken a measure pursuant to paragraph 1 and considers that final measures need urgently be adopted, it may request an urgent opinion or an urgent binding decision from the Board, giving reasons for requesting such opinion or decision. 3. Any supervisory authority may request an urgent opinion or an urgent binding decision, as the case may be, from the Board where a competent supervisory authority has not taken an appropriate measure in a situation where there is an urgent need to act, in order to protect the rights and freedoms of data subjects, giving reasons for requesting such opinion or decision, including for the urgent need to act. 4. By derogation from Article 64(3) and Article 65(2), an urgent opinion or an urgent binding decision referred to in paragraphs 2 and 3 of this Article shall be adopted within two weeks by simple majority of the members of the Board. Article 67 Exchange of information The Commission may adopt implementing acts of general scope in order to specify the arrangements for the exchange of information by electronic means between supervisory authorities, and between supervisory authorities and the Board, in particular the standardised format referred to in Article 64. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2). Section 3 European data protection board Article 68 European Data Protection Board 1. The European Data Protection Board (the ‘Board’) is hereby established as a body of the Union and shall have legal personality. 2. The Board shall be represented by its Chair. 3. The Board shall be composed of the head of one supervisory authority of each Member State and of the European Data Protection Supervisor, or their respective representatives. 4. Where in a Member State more than one supervisory authority is responsible for monitoring the application of the provisions pursuant to this Regulation, a joint representative shall be appointed in accordance with that Member State's law. 5. The Commission shall have the right to participate in the activities and meetings of the Board without voting right. The Commission shall designate a representative. The Chair of the Board shall communicate to the Commission the activities of the Board. 6. In the cases referred to in Article 65, the European Data Protection Supervisor shall have voting rights only on decisions which concern principles and rules applicable to the Union institutions, bodies, offices and agencies which correspond in substance to those of this Regulation. Article 69 Independence 1. The Board shall act independently when performing its tasks or exercising its powers pursuant to Articles 70 and 71. 2. Without prejudice to requests by the Commission referred to in point (b) of Article 70(1) and in Article 70(2), the Board shall, in the performance of its tasks or the exercise of its powers, neither seek nor take instructions from anybody. Article 70 Tasks of the Board 1. The Board shall ensure the consistent application of this Regulation. To that end, the Board shall, on its own initiative or, where relevant, at the request of the Commission, in particular: (a) monitor and ensure the correct application of this Regulation in the cases provided for in Articles 64 and 65 without prejudice to the tasks of national supervisory authorities; (b) advise the Commission on any issue related to the protection of personal data in the Union, including on any proposed amendment of this Regulation; (c) advise the Commission on the format and procedures for the exchange of information between controllers, processors and supervisory authorities for binding corporate rules; (d) issue guidelines, recommendations, and best practices on procedures for erasing links, copies or replications of personal data from publicly available communication services as referred to in Article 17(2); (e) examine, on its own initiative, on request of one of its members or on request of the Commission, any question covering the application of this Regulation and issue guidelines, recommendations and best practices in order to encourage consistent application of this Regulation; (f) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for further specifying the criteria and conditions for decisions based on profiling pursuant to Article 22(2); (g) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for establishing the personal data breaches and determining the undue delay referred to in Article 33(1) and (2) and for the particular circumstances in which a controller or a processor is required to notify the personal data breach; (h) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph as to the circumstances in which a personal data breach is likely to result in a high risk to the rights and freedoms of the natural persons referred to in Article 34(1). (i) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for the purpose of further specifying the criteria and requirements for personal data transfers based on binding corporate rules adhered to by controllers and binding corporate rules adhered to by processors and on further necessary requirements to ensure the protection of personal data of the data subjects concerned referred to in Article 47; (j) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for the purpose of further specifying the criteria and requirements for the personal data transfers on the basis of Article 49(1); (k) draw up guidelines for supervisory authorities concerning the application of measures referred to in Article 58(1), (2) and (3) and the setting of administrative fines pursuant to Article 83; (l) review the practical application of the guidelines, recommendations and best practices referred to in points (e) and (f); (m) issue guidelines, recommendations and best practices in accordance with point (e) of this paragraph for establishing common procedures for reporting by natural persons of infringements of this Regulation pursuant to Article 54(2); (n) encourage the drawing-up of codes of conduct and the establishment of data protection certification mechanisms and data protection seals and marks pursuant to Articles 40 and 42; (o) carry out the accreditation of certification bodies and its periodic review pursuant to Article 43 and maintain a public register of accredited bodies pursuant to Article 43(6) and of the accredited controllers or processors established in third countries pursuant to Article 42(7); (p) specify the requirements referred to in Article 43(3) with a view to the accreditation of certification bodies under Article 42; (q) provide the Commission with an opinion on the certification requirements referred to in Article 43(8); (r) provide the Commission with an opinion on the icons referred to in Article 12(7); (s) provide the Commission with an opinion for the assessment of the adequacy of the level of protection in a third country or international organisation, including for the assessment whether a third country, a territory or one or more specified sectors within that third country, or an international organisation no longer ensures an adequate level of protection. To that end, the Commission shall provide the Board with all necessary documentation, including correspondence with the government of the third country, with regard to that third country, territory or specified sector, or with the international organisation. (t) issue opinions on draft decisions of supervisory authorities pursuant to the consistency mechanism referred to in Article 64(1), on matters submitted pursuant to Article 64(2) and to issue binding decisions pursuant to Article 65, including in cases referred to in Article 66; (u) promote the cooperation and the effective bilateral and multilateral exchange of information and best practices between the supervisory authorities; (v) promote common training programmes and facilitate personnel exchanges between the supervisory authorities and, where appropriate, with the supervisory authorities of third countries or with international organisations; (w) promote the exchange of knowledge and documentation on data protection legislation and practice with data protection supervisory authorities worldwide. (x) issue opinions on codes of conduct drawn up at Union level pursuant to Article 40(9); and (y) maintain a publicly accessible electronic register of decisions taken by supervisory authorities and courts on issues handled in the consistency mechanism. 2. Where the Commission requests advice from the Board, it may indicate a time limit, taking into account the urgency of the matter. 3. The Board shall forward its opinions, guidelines, recommendations, and best practices to the Commission and to the committee referred to in Article 93 and make them public. 4. The Board shall, where appropriate, consult interested parties and give them the opportunity to comment within a reasonable period. The Board shall, without prejudice to Article 76, make the results of the consultation procedure publicly available. Article 71 Reports 1. The Board shall draw up an annual report regarding the protection of natural persons with regard to processing in the Union and, where relevant, in third countries and international organisations. The report shall be made public and be transmitted to the European Parliament, to the Council and to the Commission. 2. The annual report shall include a review of the practical application of the guidelines, recommendations and best practices referred to in point (l) of Article 70(1) as well as of the binding decisions referred to in Article 65. Article 72 Procedure 1. The Board shall take decisions by a simple majority of its members, unless otherwise provided for in this Regulation. 2. The Board shall adopt its own rules of procedure by a two-thirds majority of its members and organise its own operational arrangements. Article 73 Chair 1. The Board shall elect a chair and two deputy chairs from amongst its members by simple majority. 2. The term of office of the Chair and of the deputy chairs shall be five years and be renewable once. Article 74 Tasks of the Chair 1. The Chair shall have the following tasks: (a) to convene the meetings of the Board and prepare its agenda; (b) to notify decisions adopted by the Board pursuant to Article 65 to the lead supervisory authority and the supervisory authorities concerned; (c) to ensure the timely performance of the tasks of the Board, in particular in relation to the consistency mechanism referred to in Article 63. 2. The Board shall lay down the allocation of tasks between the Chair and the deputy chairs in its rules of procedure. Article 75 Secretariat 1. The Board shall have a secretariat, which shall be provided by the European Data Protection Supervisor. 2. The secretariat shall perform its tasks exclusively under the instructions of the Chair of the Board. 3. The staff of the European Data Protection Supervisor involved in carrying out the tasks conferred on the Board by this Regulation shall be subject to separate reporting lines from the staff involved in carrying out tasks conferred on the European Data Protection Supervisor. 4. Where appropriate, the Board and the European Data Protection Supervisor shall establish and publish a Memorandum of Understanding implementing this Article, determining the terms of their cooperation, and applicable to the staff of the European Data Protection Supervisor involved in carrying out the tasks conferred on the Board by this Regulation. 5. The secretariat shall provide analytical, administrative and logistical support to the Board. 6. The secretariat shall be responsible in particular for: (a) the day-to-day business of the Board; (b) communication between the members of the Board, its Chair and the Commission; (c) communication with other institutions and the public; (d) the use of electronic means for the internal and external communication; (e) the translation of relevant information; (f) the preparation and follow-up of the meetings of the Board; (g) the preparation, drafting and publication of opinions, decisions on the settlement of disputes between supervisory authorities and other texts adopted by the Board. Article 76 Confidentiality 1. The discussions of the Board shall be confidential where the Board deems it necessary, as provided for in its rules of procedure. 2. Access to documents submitted to members of the Board, experts and representatives of third parties shall be governed by Regulation (EC) No 1049/2001 of the European Parliament and of the Council (21). CHAPTER VIII Remedies, liability and penalties Article 77 Right to lodge a complaint with a supervisory authority 1. Without prejudice to any other administrative or judicial remedy, every data subject shall have the right to lodge a complaint with a supervisory authority, in particular in the Member State of his or her habitual residence, place of work or place of the alleged infringement if the data subject considers that the processing of personal data relating to him or her infringes this Regulation. 2. The supervisory authority with which the complaint has been lodged shall inform the complainant on the progress and the outcome of the complaint including the possibility of a judicial remedy pursuant to Article 78. Article 78 Right to an effective judicial remedy against a supervisory authority 1. Without prejudice to any other administrative or non-judicial remedy, each natural or legal person shall have the right to an effective judicial remedy against a legally binding decision of a supervisory authority concerning them. 2. Without prejudice to any other administrative or non-judicial remedy, each data subject shall have the right to a an effective judicial remedy where the supervisory authority which is competent pursuant to Articles 55 and 56 does not handle a complaint or does not inform the data subject within three months on the progress or outcome of the complaint lodged pursuant to Article 77. 3. Proceedings against a supervisory authority shall be brought before the courts of the Member State where the supervisory authority is established. 4. Where proceedings are brought against a decision of a supervisory authority which was preceded by an opinion or a decision of the Board in the consistency mechanism, the supervisory authority shall forward that opinion or decision to the court. Article 79 Right to an effective judicial remedy against a controller or processor 1. Without prejudice to any available administrative or non-judicial remedy, including the right to lodge a complaint with a supervisory authority pursuant to Article 77, each data subject shall have the right to an effective judicial remedy where he or she considers that his or her rights under this Regulation have been infringed as a result of the processing of his or her personal data in non-compliance with this Regulation. 2. Proceedings against a controller or a processor shall be brought before the courts of the Member State where the controller or processor has an establishment. Alternatively, such proceedings may be brought before the courts of the Member State where the data subject has his or her habitual residence, unless the controller or processor is a public authority of a Member State acting in the exercise of its public powers. Article 80 Representation of data subjects 1. The data subject shall have the right to mandate a not-for-profit body, organisation or association which has been properly constituted in accordance with the law of a Member State, has statutory objectives which are in the public interest, and is active in the field of the protection of data subjects' rights and freedoms with regard to the protection of their personal data to lodge the complaint on his or her behalf, to exercise the rights referred to in Articles 77, 78 and 79 on his or her behalf, and to exercise the right to receive compensation referred to in Article 82 on his or her behalf where provided for by Member State law. 2. Member States may provide that any body, organisation or association referred to in paragraph 1 of this Article, independently of a data subject's mandate, has the right to lodge, in that Member State, a complaint with the supervisory authority which is competent pursuant to Article 77 and to exercise the rights referred to in Articles 78 and 79 if it considers that the rights of a data subject under this Regulation have been infringed as a result of the processing. Article 81 Suspension of proceedings 1. Where a competent court of a Member State has information on proceedings, concerning the same subject matter as regards processing by the same controller or processor, that are pending in a court in another Member State, it shall contact that court in the other Member State to confirm the existence of such proceedings. 2. Where proceedings concerning the same subject matter as regards processing of the same controller or processor are pending in a court in another Member State, any competent court other than the court first seized may suspend its proceedings. 3. Where those proceedings are pending at first instance, any court other than the court first seized may also, on the application of one of the parties, decline jurisdiction if the court first seized has jurisdiction over the actions in question and its law permits the consolidation thereof. Article 82 Right to compensation and liability 1. Any person who has suffered material or non-material damage as a result of an infringement of this Regulation shall have the right to receive compensation from the controller or processor for the damage suffered. 2. Any controller involved in processing shall be liable for the damage caused by processing which infringes this Regulation. A processor shall be liable for the damage caused by processing only where it has not complied with obligations of this Regulation specifically directed to processors or where it has acted outside or contrary to lawful instructions of the controller. 3. A controller or processor shall be exempt from liability under paragraph 2 if it proves that it is not in any way responsible for the event giving rise to the damage. 4. Where more than one controller or processor, or both a controller and a processor, are involved in the same processing and where they are, under paragraphs 2 and 3, responsible for any damage caused by processing, each controller or processor shall be held liable for the entire damage in order to ensure effective compensation of the data subject. 5. Where a controller or processor has, in accordance with paragraph 4, paid full compensation for the damage suffered, that controller or processor shall be entitled to claim back from the other controllers or processors involved in the same processing that part of the compensation corresponding to their part of responsibility for the damage, in accordance with the conditions set out in paragraph 2. 6. Court proceedings for exercising the right to receive compensation shall be brought before the courts competent under the law of the Member State referred to in Article 79(2). Article 83 General conditions for imposing administrative fines 1. Each supervisory authority shall ensure that the imposition of administrative fines pursuant to this Article in respect of infringements of this Regulation referred to in paragraphs 4, 5 and 6 shall in each individual case be effective, proportionate and dissuasive. 2. Administrative fines shall, depending on the circumstances of each individual case, be imposed in addition to, or instead of, measures referred to in points (a) to (h) and (j) of Article 58(2). When deciding whether to impose an administrative fine and deciding on the amount of the administrative fine in each individual case due regard shall be given to the following: (a) the nature, gravity and duration of the infringement taking into account the nature scope or purpose of the processing concerned as well as the number of data subjects affected and the level of damage suffered by them; (b) the intentional or negligent character of the infringement; (c) any action taken by the controller or processor to mitigate the damage suffered by data subjects; (d) the degree of responsibility of the controller or processor taking into account technical and organisational measures implemented by them pursuant to Articles 25 and 32; (e) any relevant previous infringements by the controller or processor; (f) the degree of cooperation with the supervisory authority, in order to remedy the infringement and mitigate the possible adverse effects of the infringement; (g) the categories of personal data affected by the infringement; (h) the manner in which the infringement became known to the supervisory authority, in particular whether, and if so to what extent, the controller or processor notified the infringement; (i) where measures referred to in Article 58(2) have previously been ordered against the controller or processor concerned with regard to the same subject-matter, compliance with those measures; (j) adherence to approved codes of conduct pursuant to Article 40 or approved certification mechanisms pursuant to Article 42; and (k) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement. 3. If a controller or processor intentionally or negligently, for the same or linked processing operations, infringes several provisions of this Regulation, the total amount of the administrative fine shall not exceed the amount specified for the gravest infringement. 4. Infringements of the following provisions shall, in accordance with paragraph 2, be subject to administrative fines up to 10 000 000 EUR, or in the case of an undertaking, up to 2 % of the total worldwide annual turnover of the preceding financial year, whichever is higher: (a) the obligations of the controller and the processor pursuant to Articles 8, 11, 25 to 39 and 42 and 43; (b) the obligations of the certification body pursuant to Articles 42 and 43; (c) the obligations of the monitoring body pursuant to Article 41(4). 5. Infringements of the following provisions shall, in accordance with paragraph 2, be subject to administrative fines up to 20 000 000 EUR, or in the case of an undertaking, up to 4 % of the total worldwide annual turnover of the preceding financial year, whichever is higher: (a) the basic principles for processing, including conditions for consent, pursuant to Articles 5, 6, 7 and 9; (b) the data subjects' rights pursuant to Articles 12 to 22; (c) the transfers of personal data to a recipient in a third country or an international organisation pursuant to Articles 44 to 49; (d) any obligations pursuant to Member State law adopted under Chapter IX; (e) non-compliance with an order or a temporary or definitive limitation on processing or the suspension of data flows by the supervisory authority pursuant to Article 58(2) or failure to provide access in violation of Article 58(1). 6. Non-compliance with an order by the supervisory authority as referred to in Article 58(2) shall, in accordance with paragraph 2 of this Article, be subject to administrative fines up to 20 000 000 EUR, or in the case of an undertaking, up to 4 % of the total worldwide annual turnover of the preceding financial year, whichever is higher. 7. Without prejudice to the corrective powers of supervisory authorities pursuant to Article 58(2), each Member State may lay down the rules on whether and to what extent administrative fines may be imposed on public authorities and bodies established in that Member State. 8. The exercise by the supervisory authority of its powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and Member State law, including effective judicial remedy and due process. 9. Where the legal system of the Member State does not provide for administrative fines, this Article may be applied in such a manner that the fine is initiated by the competent supervisory authority and imposed by competent national courts, while ensuring that those legal remedies are effective and have an equivalent effect to the administrative fines imposed by supervisory authorities. In any event, the fines imposed shall be effective, proportionate and dissuasive. Those Member States shall notify to the Commission the provisions of their laws which they adopt pursuant to this paragraph by 25 May 2018 and, without delay, any subsequent amendment law or amendment affecting them. Article 84 Penalties 1. Member States shall lay down the rules on other penalties applicable to infringements of this Regulation in particular for infringements which are not subject to administrative fines pursuant to Article 83, and shall take all measures necessary to ensure that they are implemented. Such penalties shall be effective, proportionate and dissuasive. 2. Each Member State shall notify to the Commission the provisions of its law which it adopts pursuant to paragraph 1, by 25 May 2018 and, without delay, any subsequent amendment affecting them. CHAPTER IX Provisions relating to specific processing situations Article 85 Processing and freedom of expression and information 1. Member States shall by law reconcile the right to the protection of personal data pursuant to this Regulation with the right to freedom of expression and information, including processing for journalistic purposes and the purposes of academic, artistic or literary expression. 2. For processing carried out for journalistic purposes or the purpose of academic artistic or literary expression, Member States shall provide for exemptions or derogations from Chapter II (principles), Chapter III (rights of the data subject), Chapter IV (controller and processor), Chapter V (transfer of personal data to third countries or international organisations), Chapter VI (independent supervisory authorities), Chapter VII (cooperation and consistency) and Chapter IX (specific data processing situations) if they are necessary to reconcile the right to the protection of personal data with the freedom of expression and information. 3. Each Member State shall notify to the Commission the provisions of its law which it has adopted pursuant to paragraph 2 and, without delay, any subsequent amendment law or amendment affecting them. Article 86 Processing and public access to official documents Personal data in official documents held by a public authority or a public body or a private body for the performance of a task carried out in the public interest may be disclosed by the authority or body in accordance with Union or Member State law to which the public authority or body is subject in order to reconcile public access to official documents with the right to the protection of personal data pursuant to this Regulation. Article 87 Processing of the national identification number Member States may further determine the specific conditions for the processing of a national identification number or any other identifier of general application. In that case the national identification number or any other identifier of general application shall be used only under appropriate safeguards for the rights and freedoms of the data subject pursuant to this Regulation. Article 88 Processing in the context of employment 1. Member States may, by law or by collective agreements, provide for more specific rules to ensure the protection of the rights and freedoms in respect of the processing of employees' personal data in the employment context, in particular for the purposes of the recruitment, the performance of the contract of employment, including discharge of obligations laid down by law or by collective agreements, management, planning and organisation of work, equality and diversity in the workplace, health and safety at work, protection of employer's or customer's property and for the purposes of the exercise and enjoyment, on an individual or collective basis, of rights and benefits related to employment, and for the purpose of the termination of the employment relationship. 2. Those rules shall include suitable and specific measures to safeguard the data subject's human dignity, legitimate interests and fundamental rights, with particular regard to the transparency of processing, the transfer of personal data within a group of undertakings, or a group of enterprises engaged in a joint economic activity and monitoring systems at the work place. 3. Each Member State shall notify to the Commission those provisions of its law which it adopts pursuant to paragraph 1, by 25 May 2018 and, without delay, any subsequent amendment affecting them. Article 89 Safeguards and derogations relating to processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes 1. Processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes, shall be subject to appropriate safeguards, in accordance with this Regulation, for the rights and freedoms of the data subject. Those safeguards shall ensure that technical and organisational measures are in place in particular in order to ensure respect for the principle of data minimisation. Those measures may include pseudonymisation provided that those purposes can be fulfilled in that manner. Where those purposes can be fulfilled by further processing which does not permit or no longer permits the identification of data subjects, those purposes shall be fulfilled in that manner. 2. Where personal data are processed for scientific or historical research purposes or statistical purposes, Union or Member State law may provide for derogations from the rights referred to in Articles 15, 16, 18 and 21 subject to the conditions and safeguards referred to in paragraph 1 of this Article in so far as such rights are likely to render impossible or seriously impair the achievement of the specific purposes, and such derogations are necessary for the fulfilment of those purposes. 3. Where personal data are processed for archiving purposes in the public interest, Union or Member State law may provide for derogations from the rights referred to in Articles 15, 16, 18, 19, 20 and 21 subject to the conditions and safeguards referred to in paragraph 1 of this Article in so far as such rights are likely to render impossible or seriously impair the achievement of the specific purposes, and such derogations are necessary for the fulfilment of those purposes. 4. Where processing referred to in paragraphs 2 and 3 serves at the same time another purpose, the derogations shall apply only to processing for the purposes referred to in those paragraphs. Article 90 Obligations of secrecy 1. Member States may adopt specific rules to set out the powers of the supervisory authorities laid down in points (e) and (f) of Article 58(1) in relation to controllers or processors that are subject, under Union or Member State law or rules established by national competent bodies, to an obligation of professional secrecy or other equivalent obligations of secrecy where this is necessary and proportionate to reconcile the right of the protection of personal data with the obligation of secrecy. Those rules shall apply only with regard to personal data which the controller or processor has received as a result of or has obtained in an activity covered by that obligation of secrecy. 2. Each Member State shall notify to the Commission the rules adopted pursuant to paragraph 1, by 25 May 2018 and, without delay, any subsequent amendment affecting them. Article 91 Existing data protection rules of churches and religious associations 1. Where in a Member State, churches and religious associations or communities apply, at the time of entry into force of this Regulation, comprehensive rules relating to the protection of natural persons with regard to processing, such rules may continue to apply, provided that they are brought into line with this Regulation. 2. Churches and religious associations which apply comprehensive rules in accordance with paragraph 1 of this Article shall be subject to the supervision of an independent supervisory authority, which may be specific, provided that it fulfils the conditions laid down in Chapter VI of this Regulation. CHAPTER X Delegated acts and implementing acts Article 92 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Article 12(8) and Article 43(8) shall be conferred on the Commission for an indeterminate period of time from 24 May 2016. 3. The delegation of power referred to in Article 12(8) and Article 43(8) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of power specified in that decision. It shall take effect the day following that of its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 12(8) and Article 43(8) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council. Article 93 Committee procedure 1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply. CHAPTER XI Final provisions Article 94 Repeal of Directive 95/46/EC 1. Directive 95/46/EC is repealed with effect from 25 May 2018. 2. References to the repealed Directive shall be construed as references to this Regulation. References to the Working Party on the Protection of Individuals with regard to the Processing of Personal Data established by Article 29 of Directive 95/46/EC shall be construed as references to the European Data Protection Board established by this Regulation. Article 95 Relationship with Directive 2002/58/EC This Regulation shall not impose additional obligations on natural or legal persons in relation to processing in connection with the provision of publicly available electronic communications services in public communication networks in the Union in relation to matters for which they are subject to specific obligations with the same objective set out in Directive 2002/58/EC. Article 96 Relationship with previously concluded Agreements International agreements involving the transfer of personal data to third countries or international organisations which were concluded by Member States prior to 24 May 2016, and which comply with Union law as applicable prior to that date, shall remain in force until amended, replaced or revoked. Article 97 Commission reports 1. By 25 May 2020 and every four years thereafter, the Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The reports shall be made public. 2. In the context of the evaluations and reviews referred to in paragraph 1, the Commission shall examine, in particular, the application and functioning of: (a) Chapter V on the transfer of personal data to third countries or international organisations with particular regard to decisions adopted pursuant to Article 45(3) of this Regulation and decisions adopted on the basis of Article 25(6) of Directive 95/46/EC; (b) Chapter VII on cooperation and consistency. 3. For the purpose of paragraph 1, the Commission may request information from Member States and supervisory authorities. 4. In carrying out the evaluations and reviews referred to in paragraphs 1 and 2, the Commission shall take into account the positions and findings of the European Parliament, of the Council, and of other relevant bodies or sources. 5. The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into account of developments in information technology and in the light of the state of progress in the information society. Article 98 Review of other Union legal acts on data protection The Commission shall, if appropriate, submit legislative proposals with a view to amending other Union legal acts on the protection of personal data, in order to ensure uniform and consistent protection of natural persons with regard to processing. This shall in particular concern the rules relating to the protection of natural persons with regard to processing by Union institutions, bodies, offices and agencies and on the free movement of such data. Article 99 Entry into force and application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 25 May 2018. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 27 April 2016. For the European Parliament The President M. SCHULZ For the Council The President J.A. HENNIS-PLASSCHAERT (1) OJ C 229, 31.7.2012, p. 90. (2) OJ C 391, 18.12.2012, p. 127. (3) Position of the European Parliament of 12 March 2014 (not yet published in the Official Journal) and position of the Council at first reading of 8 April 2016 (not yet published in the Official Journal). Position of the European Parliament of 14 April 2016. (4) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31). (5) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (C(2003) 1422) (OJ L 124, 20.5.2003, p. 36). (6) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). (7) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and the free movement of such data and repealing Council Framework Decision 2008/977/JHA (see page 89 of this Official Journal). (8) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (‘Directive on electronic commerce’) (OJ L 178, 17.7.2000, p. 1). (9) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). (10) Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29). (11) Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work (OJ L 354, 31.12.2008, p. 70). (12) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (13) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1). (14) Directive 2003/98/EC of the European Parliament and of the Council of 17 November 2003 on the re-use of public sector information (OJ L 345, 31.12.2003, p. 90). (15) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1). (16) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164). (17) OJ C 192, 30.6.2012, p. 7. (18) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37). (19) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). (20) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (21) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

General data protection regulation (GDPR) General data protection regulation (GDPR) SUMMARY OF: Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and the free movement of such data WHAT IS THE AIM OF THE REGULATION? The general data protection regulation (GDPR) protects individuals when their data is being processed by the private sector and most of the public sector. The processing of data by the relevant authorities for law-enforcement purposes is subject to the data protection law enforcement directive (LED) instead (see summary). It allows individuals to better control their personal data. It also modernises and unifies rules, allowing businesses to reduce red tape and to benefit from greater consumer trust. It establishes a system of completely independent supervisory authorities in charge of monitoring and enforcing compliance. It is part of the European Union (EU) data protection reform, along with the data protection law enforcement directive and Regulation (EU) 2018/1725 on the protection of natural persons with regard to the processing of personal data by the EU institutions, bodies, offices and agencies (see summary). KEY POINTS Individuals’ rights The GDPR strengthens existing rights, provides for new rights and gives individuals more control over their personal data. It includes the following. Easier access to an individual's own data. This includes providing more information on how that data is processed and ensuring that that information is available in a clear and understandable way. A new right to data portability. This makes it easier to transmit personal data between service providers. A clearer right to erasure (right to be forgotten). When an individual no longer wants their data to be processed and there is no legitimate reason to keep it, the data will be deleted. The right to know when their personal data has been breached. Companies and organisations have to notify the relevant data protection supervisory authority and, in cases of serious data breaches, also the individuals affected. Rules for businesses The GDPR creates a level playing field for all companies operating in the EU internal market, adopts a technology-neutral approach and stimulates innovation through a number of steps, which include the following. A single set of EU-wide rules. A single EU-wide law for data protection increases legal certainty and reduces administrative burden. A data protection officer. A person responsible for data protection has to be designated by public authorities and by businesses that process data on a large scale, or whose core activity is the processing of special categories of data, such as health-related data. One-stop shop. Businesses only have to deal with one single supervisory authority (in the EU Member State in which they have their main establishment); the relevant supervisory authorities cooperate in the framework of the European Data Protection Board for cross-border cases. EU rules for non-EU companies. Companies based outside the EU must apply the same rules when offering services or goods to, or when monitoring the behaviours of, individuals within the EU. Innovation-friendly rules. A guarantee that data protection safeguards are built into products and services from the earliest stage of development (data protection by design and by default). Privacy-friendly techniques. Pseudonymisation (when identifying fields within a data record are replaced by one or more artificial identifiers) and encryption (when data is coded in such a way that only authorised parties can read it), for example, are encouraged, in order to limit the intrusiveness of processing. Removal of notifications. The GDPR scrapped most notification obligations and the costs associated with these. One of its aims is to remove obstacles that affect the free flow of personal data within the EU. This will make it easier for businesses to expand in the single digital market. Data protection impact assessments. Organisations will have to carry out impact assessments when data processing may result in a high risk for the rights and freedoms of individuals. Record keeping. Small and medium-sized enterprises are not required to keep records of processing activities – unless the processing is regular or likely to result in a risk to the rights and freedoms of the person whose data is being processed, or includes sensitive categories of data. A modern toolbox for international data transfers. The GDPR offers various instruments to transfer data outside the EU, including adequacy decisions adopted by the European Commission where the non-EU country offers an adequate level of protection, pre-approved (standard) contractual clauses, binding corporate rules, codes of conduct and certification. Review The Commission submitted a report on the evaluation and review of the regulation in June 2020. The next evaluation is due in 2024. FROM WHEN DOES THE REGULATION APPLY? The GDPR has applied since 25 May 2018. BACKGROUND For further information, see: Reform of EU data protection rules (European Commission) EU data protection rules (European Commission) Commission report: EU data protection rules empower citizens and are fit for the digital age – press release (European Commission) Data protection reform – press release (European Commission) Protection of personal data (European Commission). Following the COVID-19 outbreak and the introduction of measures to cope with the impact of the crisis, the Commission adopted: Commission Recommendation (EU) 2020/518 of 8 April 2020 on a common Union toolbox for the use of technology and data to combat and exit from the COVID-19 crisis, in particular concerning mobile applications and the use of anonymised mobility data. MAIN DOCUMENT Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1–88). Successive amendments to Regulation (EU) 2016/679 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, pp. 89–131). See consolidated version. Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, pp. 39–98). Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, pp. 37–47). See consolidated version. last update 07.01.2022

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16.9.2016 EN Official Journal of the European Union L 252/1 REGULATION (EU) 2016/1627 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 September 2016 on a multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean, and repealing Council Regulation (EC) No 302/2009 THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The objective of the common fisheries policy (CFP), as set out in Regulation (EU) No 1380/2013 of the European Parliament and of the Council (3), is to ensure an exploitation of living aquatic resources that provides sustainable economic, environmental and social conditions. (2) The Union is Party to the International Convention for the Conservation of Atlantic Tunas (4) (‘the Convention’). (3) At its 15th special meeting in 2006, the International Commission for the Conservation of Atlantic Tunas (‘ICCAT’), established by the Convention, adopted Recommendation 06-05 establishing a multiannual recovery plan for bluefin tuna in the eastern Atlantic and Mediterranean ending in 2022 (‘the recovery plan’). That Recommendation entered into force on 13 June 2007. (4) The recovery plan takes into account the specificities of the different types of gear and fishing techniques. When implementing the recovery plan, the Union and Member States should endeavour to promote coastal fishing activities and the use of fishing gear and techniques which are selective and have a reduced environmental impact, including gear and techniques used in traditional and artisanal fisheries, thereby contributing to a fair standard of living for local economies. (5) ICCAT Recommendation 06-05 was implemented into Union law by Council Regulation (EC) No 1559/2007 (5). (6) At its 16th special meeting in 2008, ICCAT adopted Recommendation 08-05 amending Recommendation 06-05. In order to rebuild the stock of bluefin tuna, Recommendation 08-05 provided for a gradual reduction in the total allowable catch level from 2007 to 2011, restrictions on fishing within certain areas and time periods, a new minimum size for bluefin tuna, measures concerning sport and recreational fishing activities, farming and fishing capacity measures, as well as reinforcing the ICCAT Scheme of Joint International Inspection. (7) ICCAT Recommendation 08-05 was implemented into Union law by Council Regulation (EC) No 302/2009 (6). (8) At its 17th special meeting in 2010, ICCAT adopted Recommendation 10-04 amending Recommendation 08-05. In order to rebuild the stock of bluefin tuna, Recommendation 10-04 established a further reduction of the total allowable catch and the fishing capacity and it reinforced the control measures, in particular those concerning transfer and caging operations. It also provided for additional advice by the Standing Committee on Research and Statistics of ICCAT (‘SCRS’) in 2012 on the identification of spawning grounds and on the creation of sanctuaries. (9) In order to implement the revised international conservation measures set out in Recommendation 10-04 into Union law, Regulation (EC) No 302/2009 was amended by Regulation (EU) No 500/2012 of the European Parliament and of the Council (7). (10) At its 18th special meeting in 2012, ICCAT adopted Recommendation 12-03 amending Recommendation 10-04. In order to strengthen the effectiveness of the recovery plan, Recommendation 12-03 set up technical measures concerning the transfer and caging operations of live bluefin tuna, new catch reporting requirements, the implementation of the ICCAT regional observer programme and changes of the fishing seasons. Furthermore, it reinforced the role of the SCRS with regard to the assessment of bluefin tuna stock. (11) At its 23rd regular meeting in 2013, ICCAT adopted Recommendation 13-07 amending Recommendation 12-03 by introducing small changes on fishing seasons which do not affect the Union fleet. Furthermore, Recommendation 13-08 was adopted which complements the recovery plan. Recommendation 13-08 set up a common procedure for the use of stereoscopical camera systems to estimate the quantities of bluefin tuna at the point of caging and introduced a flexible starting date for the fishing season of baitboats and trolling boats in the eastern Atlantic. (12) In order to implement essential measures, such as those on fishing seasons, of Recommendations 12-03 and 13-08 into Union law, Regulation (EC) No 302/2009 was further amended by Regulation (EU) No 544/2014 of the European Parliament and of the Council (8). (13) At its 19th special meeting in 2014, ICCAT adopted Recommendation 14-04 amending Recommendation 13-07 and repealing Recommendation 13-08. Whilst some of the existing control provisions were rationalised, the procedures for the use of stereoscopic camera at the point of caging were further specified and measures specific to release operations and the treatment of dead fish were introduced in the recovery plan. (14) Recommendation 14-04 is binding on the Union. (15) All the amendments to the recovery plan adopted by ICCAT in 2012, 2013 and 2014, which have not yet been subject to implementation, should be implemented into Union law. As that implementation concerns the recovery plan whose objectives and measures were defined by ICCAT, this Regulation does not cover all the content of multiannual plans as set out in Articles 9 and 10 of Regulation (EU) No 1380/2013. (16) Regulation (EU) No 1380/2013 establishes the concept of minimum conservation reference sizes. In order to ensure consistency, the ICCAT concept of minimum sizes should be transposed into Union law as minimum conservation reference sizes. Consequently, the references in Commission Delegated Regulation (EU) 2015/98 (9) to minimum sizes of bluefin tuna should be read as references to minimum conservation reference sizes in this Regulation. (17) In order to ensure uniform conditions for the implementation of the provisions of this Regulation relating to transfer operations, caging operations and recording and reporting of trap and vessel activities, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (10). (18) Certain provisions of Regulation (EC) No 302/2009 have become obsolete, in particular since they are now covered by other Union acts. Other provisions should be updated in order to reflect changes in legislation, in particular those resulting from the adoption of Regulation (EU) No 1380/2013. (19) In particular, Council Regulation (EC) No 1224/2009 (11) establishes a Union system for control, inspection and enforcement with a global and integrated approach so as to ensure compliance with all the rules of the CFP, and Commission Implementing Regulation (EU) No 404/2011 (12) lays down detailed rules for the implementation of Regulation (EC) No 1224/2009. Council Regulation (EC) No 1005/2008 (13) establishes a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing. Those acts now cover some matters governed by Regulation (EC) No 302/2009 and, in particular, Article 33 thereof on enforcement measures and Annex VIII on vessel monitoring system (VMS) transmission. It is therefore not necessary to include those provisions in this Regulation. (20) In accordance with Implementing Regulation (EU) No 404/2011, the conversion factors adopted by the SCRS apply to calculate the equivalent round weight of processed bluefin tuna, including for the purpose of this Regulation. (21) Moreover, in accordance with Article 95 of Regulation (EC) No 1224/2009, Commission Implementing Decision 2014/156/EU (14) has been adopted. That Implementing Decision establishes, inter alia, target benchmarks and objectives for the control of the bluefin tuna fishery in the eastern Atlantic and the Mediterranean. (22) ICCAT Recommendation 06-07 set up a sampling programme for the estimation of the number-at-size in the context of bluefin tuna farming activities. That provision was implemented by Article 10 of Regulation (EC) No 302/2009. It is not necessary that this Regulation specifically provides for the sampling programme, as the needs of that sampling programme are now fully covered by the programmes set up by paragraph 83 of Recommendation 14-04, which is to be implemented by this Regulation. (23) For reasons of clarity, simplification and legal certainty, Regulation (EC) No 302/2009 should therefore be repealed. (24) For the purpose of the Union's compliance with its international obligations under the Convention, Delegated Regulation (EU) 2015/98 provides for derogations from the landing obligation for bluefin tuna set out in Article 15 of Regulation (EU) No 1380/2013. Delegated Regulation (EU) 2015/98 implements certain provisions of ICCAT Recommendation 13-07 that establish a discard and release obligation for vessels and traps catching bluefin tuna in the eastern Atlantic and the Mediterranean in certain cases. This Regulation therefore does not need to cover such discard and release obligations and will consequently be without prejudice to the corresponding provisions of Delegated Regulation (EU) 2015/98, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Regulation lays down the general rules for the application by the Union of the recovery plan as defined in point (1) of Article 3. 2. This Regulation applies to bluefin tuna (Thunnus thynnus) in the eastern Atlantic and the Mediterranean. Article 2 Objective The objective of this Regulation, in accordance with the recovery plan as defined in point (1) of Article 3, is to achieve a biomass of bluefin tuna corresponding to the maximum sustainable yield by 2022 with at least a 60 % probability of achieving that objective. Article 3 Definitions For the purpose of this Regulation, the following definitions apply: (1) ‘recovery plan’ means the multiannual recovery plan for bluefin tuna, which applies from 2007 to 2022 and was recommended by ICCAT; (2) ‘fishing vessel’ means any powered vessel used or intended for use for the purposes of the commercial exploitation of bluefin tuna resources, including catching vessels, processing vessels, support vessels, towing vessels, vessels engaged in transhipment and transport vessels equipped for the transportation of tuna products and auxiliary vessels, except container vessels; (3) ‘catching vessel’ means a vessel used for the purposes of the commercial capture of bluefin tuna resources; (4) ‘processing vessel’ means a vessel on board of which fisheries products are subject to one or more of the following operations, prior to their packaging: filleting or slicing, freezing and/or processing; (5) ‘auxiliary vessel’ means any vessel used to transport dead bluefin tuna (not processed) from a transport/farming cage, a purse seine net or a trap to a designated port and/or to a processing vessel; (6) ‘towing vessel’ means any vessel used for towing cages; (7) ‘support vessel’ means any other fishing vessel referred to under point (2); (8) ‘fishing actively’ means, for any catching vessel and trap, the fact that it targets bluefin tuna during a given fishing season; (9) ‘joint fishing operation’ means any operation between two or more purse seiners where the catch of one purse seiner is attributed to one or more other purse seiners in accordance with an allocation key; (10) ‘transfer operations’ means: (i) any transfer of live bluefin tuna from the catching vessel's net to the transport cage; (ii) any transfer of live bluefin tuna from the transport cage to another transport cage; (iii) any transfer of the cage with bluefin tuna from a towing vessel to another towing vessel; (iv) any transfer of live bluefin tuna from one farm to another; (v) any transfer of live bluefin tuna from the trap to the transport cage; (11) ‘control transfer’ means any additional transfer being implemented at the request of the fishing/farming operators or the control authorities for the purpose of verifying the number of fish being transferred; (12) ‘trap’ means fixed gear anchored to the bottom, usually containing a guide net that leads bluefin tuna into an enclosure or series of enclosures where it is kept prior to harvesting; (13) ‘caging’ means the transfer of live bluefin tuna from the transport cage or trap to the farming cages; (14) ‘farming’ means caging of bluefin tuna in farms and subsequent feeding aiming to fatten and increase their total biomass; (15) ‘farm’ means an installation used for the farming of bluefin tuna caught by traps and/or purse seiners; (16) ‘harvesting’ means the killing of bluefin tuna in farms or traps; (17) ‘transhipment’ means the unloading of all or any of the fish on board a fishing vessel to another fishing vessel. Unloading of dead bluefin tuna from the purse seiner net or the towing vessel to an auxiliary vessel shall not be considered as a transhipment; (18) ‘sport fishery’ means non-commercial fisheries whose members adhere to a national sport organisation or are issued with a national sport licence; (19) ‘recreational fishery’ means non-commercial fisheries whose members do not adhere to a national sport organisation and are not issued with a national sport licence; (20) ‘stereoscopic camera’ means a camera with two or more lenses, with a separate image sensor or film frame for each lens, enabling the taking of three-dimensional images; (21) ‘control camera’ means a stereoscopic camera and/or conventional video camera for the purpose of the controls provided for in this Regulation; (22) ‘BCD’ or ‘electronic BCD’ means a bluefin catch document for bluefin tuna. As appropriate, the reference to BCD shall be replaced by eBCD; (23) ‘responsible Member State’ or ‘Member State responsible’ means the flag Member State or the Member State in whose jurisdiction the trap or farm is located or, if the farm or trap is located on the high seas, the Member State where the trap or farm operator is established; (24) ‘Task II’ means Task II as defined by ICCAT in the ‘Field manual for statistics and sampling Atlantic tunas and tuna-like fish’ (third edition, ICCAT, 1990); (25) ‘CPC’ means Contracting Parties to the Convention and cooperating non-contracting parties, entities or fishing entities; (26) ‘Convention area’ means the geographical area covered by ICCAT measures as set out in Article 1 of the Convention. Article 4 Length of vessels Lengths of vessels referred to in this Regulation shall be understood as overall lengths. CHAPTER II MANAGEMENT MEASURES Article 5 Conditions associated with management measures 1. Each Member State shall take the necessary measures to ensure that the fishing effort of its catching vessels and its traps are commensurate with the bluefin tuna fishing opportunities available to that Member State in the eastern Atlantic and the Mediterranean. 2. The carrying-over of any unused quota shall be prohibited. 3. The chartering of Union fishing vessels for bluefin tuna fishing in the eastern Atlantic and the Mediterranean shall be prohibited. Article 6 Submission of annual fishing plans, fishing capacity management plans and farming management plans 1. By 31 January each year, each Member State with a bluefin tuna quota shall transmit to the Commission: (a) an annual fishing plan for the catching vessels and traps fishing bluefin tuna in the eastern Atlantic and the Mediterranean; (b) an annual fishing capacity management plan ensuring that the Member State's fishing capacity is commensurate with its allocated quota. 2. The Commission shall compile the plans referred to in paragraph 1 and integrate them into the Union fishing and capacity management plan. The Commission shall transmit that plan to the ICCAT Secretariat by 15 February of each year for discussion and approval by ICCAT. 3. By 15 April of each year, each Member State that intends to modify the ICCAT plan for farming capacity in force shall transmit an annual farming management plan to the Commission, which shall transmit it to the ICCAT Secretariat. Article 7 Annual fishing plans 1. The annual fishing plan submitted by each Member State with a bluefin tuna quota shall identify the quotas allocated to each gear group referred to in Articles 11 and 12, including information on: (a) for catching vessels over 24 metres included in the vessel list referred to in point (a) of Article 20(1) — the individual quota allocated to them and the measures in place to ensure compliance with the individual quotas and by-catch allowances; (b) for catching vessels less than 24 metres and for traps — at least the quota allocated to producer organisations or groups of vessels fishing with a similar gear type. 2. By way of derogation from point (a) of paragraph 1, the individual quota allocated to each catching vessel over 24 metres may be submitted not later than 30 days before the start of the fishing season applicable to each such vessel. 3. Any subsequent modification to the annual fishing plan or the individual quotas allocated for catching vessels over 24 metres and included in the list referred to in point (a) of Article 20(1) shall be transmitted by the Member State concerned to the Commission at least three days before the exercise of the activity corresponding to that modification. The Commission shall transmit such modification to the ICCAT Secretariat at least 48 hours before the exercise of the activity corresponding to that modification. Article 8 Allocation of fishing opportunities In accordance with Article 17 of Regulation (EU) No 1380/2013, when allocating the fishing opportunities available to them, Member States shall use transparent and objective criteria, including those of an environmental, social and economic nature, and shall also endeavour to distribute national quotas fairly among the various fleet segments giving consideration to traditional and artisanal fisheries, and to provide incentives to Union fishing vessels deploying selective fishing gear or using fishing techniques with reduced environmental impact. Article 9 Fishing capacity management plans 1. The annual fishing capacity management plan submitted by each Member State with a bluefin tuna quota shall comply with the conditions set out in this Article. 2. The maximum number of traps registered in a Member State and of fishing vessels flying the flag of a Member State that may fish for, retain on board, tranship, transport, or land bluefin tuna, shall be determined in accordance with the Treaty on the Functioning of the European Union (‘TFEU’) and Article 16 of Regulation (EU) No 1380/2013. 3. The maximum number and the corresponding gross tonnage of fishing vessels flying the flag of a Member State engaged in bluefin tuna fishery shall be limited to the number, and the total corresponding gross tonnage, of fishing vessels flying the flag of that Member State that fished for, retained on board, transhipped, transported or landed bluefin tuna from 1 January 2007 to 1 July 2008. That limit shall apply by gear type for catching vessels. 4. For vessels authorised to fish for bluefin tuna under the derogation referred to in Article 14(2), additional conditions to determine the maximum number of fishing vessels are set out in Annex I. 5. The maximum number of traps of a Member State engaged in bluefin tuna fishery shall be limited to the number of traps authorised by that Member State by 1 July 2008. 6. By way of derogation from paragraphs 3 and 5 of this Article, for the years 2016 and 2017, when a Member State can demonstrate that its fishing capacity might not allow the use of its full quota, that Member State may decide to include a higher number of vessels and traps in its annual fishing plans referred to in Article 7. 7. For the years 2016 and 2017, each Member State shall limit the numbers of its purse seiners to the numbers of purse seiners it authorised in 2013 or 2014. That shall not apply to purse seiners operating under the derogation provided for in point (b) of Article 14(2). 8. When setting up its fishing capacity management plans, calculation of the fishing capacity of each Member State shall be based on the best catch rates per vessel and gear estimated by the SCRS in its Report of 2009 and agreed by ICCAT in the 2010 Inter-sessional meeting of the ICCAT Compliance Committee (15). Following any revisions of those catch rates by the SCRS, Member States shall always apply the most recent catch rates agreed by the ICCAT. Article 10 Farming management plans 1. The annual farming management plan submitted by each Member State shall comply with the conditions set out in this Article. 2. The maximum bluefin tuna farming and fattening capacity for each Member State and the maximum input of wild-caught bluefin tuna that each Member State may allocate shall be determined in accordance with the TFEU and Article 16 of Regulation (EU) No 1380/2013. 3. The maximum bluefin tuna farming and fattening capacity of a Member State shall be limited to the bluefin tuna farming and fattening capacity of the farms of that Member State that were registered in the ICCAT record of farming facilities or authorised and declared to ICCAT on 1 July 2008. 4. The maximum input of wild-caught bluefin tuna into the farms of a Member State shall be limited to the level of the input quantities registered with ICCAT by the farms of that Member State in the years 2005, 2006, 2007 or 2008. 5. Within the maximum input quantity of wild-caught bluefin tuna referred to in paragraph 4, each Member State shall allocate maximum annual inputs to its farms. CHAPTER III TECHNICAL MEASURES SECTION 1 Fishing seasons Article 11 Longliners, purse seiners, pelagic trawlers, traps and sport and recreational fisheries 1. Bluefin tuna fishing by large-scale pelagic longline catching vessels over 24 metres shall be permitted in the eastern Atlantic and the Mediterranean from 1 January to 31 May, with the exception of the area delimited by west of 10° W and north of 42° N as well as of the Norwegian exclusive economic zone, where such fishing shall be permitted from 1 August to 31 January. 2. Purse seine fishing for bluefin tuna shall be permitted in the eastern Atlantic and the Mediterranean from 26 May to 24 June, with the exception of the Norwegian exclusive economic zone, where such fishing shall be permitted from 25 June to 31 October. 3. Bluefin tuna fishing by pelagic trawlers shall be permitted in the eastern Atlantic from 16 June to 14 October. 4. Bluefin tuna sport and recreational fishing shall be permitted in the eastern Atlantic and the Mediterranean from 16 June to 14 October. 5. Fishing for bluefin tuna by gears other than those referred to in paragraphs 1 to 4 of this Article and Article 12, including traps, shall be permitted throughout the year in accordance with ICCAT conservation and management measures. Article 12 Baitboats and trolling boats 1. Bluefin tuna fishing by baitboats and trolling boats shall be permitted in the eastern Atlantic and the Mediterranean from 1 July to 31 October. 2. Provided that the protection of the spawning grounds is not affected and that the total duration of the fishing season for those fisheries does not exceed four months, each Member State may decide on a different starting date for baitboats and trolling boats flying their flag and operating in the eastern Atlantic. 3. Each Member State shall specify, in its annual fishing plan referred to in Article 7, whether the starting dates for those fisheries have been modified, as well as the coordinates of the areas concerned. SECTION 2 Minimum conservation reference size, incidental catch, by-catch Article 13 The landing obligation The provisions of this Section shall be without prejudice to Article 15 of Regulation (EU) No 1380/2013, including any applicable derogations thereto. Article 14 Minimum conservation reference size 1. The minimum conservation reference size for bluefin tuna caught in the eastern Atlantic and the Mediterranean shall be 30 kg or 115 cm fork length. 2. By way of derogation from paragraph 1, a minimum conservation reference size for bluefin tuna of 8 kg or 75 cm fork length shall apply to the following fisheries: (a) bluefin tuna caught in the eastern Atlantic by baitboats and trolling boats; (b) bluefin tuna caught in the Adriatic Sea for farming purposes; (c) bluefin tuna caught in the Mediterranean Sea by the coastal and artisanal fishery for fresh fish by baitboats, longliners and handliners. 3. The specific conditions applying to the derogation referred to in paragraph 2 are set out in Annex I. 4. Member States concerned shall issue specific authorisations to vessels fishing under the derogation referred to in paragraph 2 of this Article. The vessels concerned shall be indicated in the list of catching vessels referred to in point (a) of Article 20(1). For that purpose, the provisions laid down in Articles 20 and 21 shall apply. Article 15 Incidental catches 1. Without prejudice to Article 14(1), incidental catches of a maximum 5 % of bluefin tuna weighing between 8 and 30 kg or with a fork length between 75 and 115 cm shall be allowed for all catching vessels and traps fishing actively for bluefin tuna. 2. The percentage of 5 % referred to in paragraph 1 shall be calculated on the basis of the total catches of bluefin tuna in number of fish retained on board the vessel or inside the trap at any time after each fishing operation. 3. Incidental catches shall be deducted from the quota of the Member State responsible for the catching vessel or trap. 4. Incidental catches of bluefin tuna shall be subject to Articles 25, 30, 31 and 32. Article 16 By-catch 1. Each Member State shall make provision for by-catch of bluefin tuna within its quota and shall inform the Commission thereof when transmitting its fishing plan. Such provision shall ensure that all dead fish are deducted from the quota. 2. Union fishing vessels not fishing actively for bluefin tuna shall avoid by-catches of bluefin tuna exceeding, at any time following a fishing operation, 5 % of the total catch on board by weight or number of fish. The calculation of that percentage by number of fish shall only apply to tuna and tuna-like species managed by ICCAT. Each Member State shall deduct all dead fish within the by-catch from its quota. 3. For Member States without a bluefin tuna quota, the by-catches concerned shall be deducted from the specific Union bluefin tuna by-catch quota established in accordance with the TFEU and Article 16 of Regulation (EU) No 1380/2013. 4. If the quota allocated to the Member State of the fishing vessel or trap concerned has already been exhausted, the catching of any bluefin tuna shall be avoided. Dead bluefin tuna shall be landed whole and unprocessed and shall be subject to confiscation and the appropriate follow-up action. In accordance with Article 29, each Member State shall provide information on the quantity of such dead bluefin tuna on an annual basis to the Commission who shall forward it to the ICCAT Secretariat. 5. The procedures referred to in Articles 27, 30, 31, 32 and 56 shall apply to by-catch. SECTION 3 Use of aerial means Article 17 Use of aerial means The use of any aerial means, including aircraft, helicopters or any types of unmanned aerial vehicles for searching for bluefin tuna shall be prohibited. CHAPTER IV SPORT AND RECREATIONAL FISHERIES Article 18 Specific quota for sport and recreational fisheries Each Member State with a bluefin tuna quota shall regulate sport and recreational fisheries by allocating a specific quota for the purpose of those fisheries and shall inform the Commission thereof when transmitting its fishing plan. Article 19 Sport and recreational fisheries 1. Each Member State with a bluefin tuna quota shall regulate sport and recreational fisheries by issuing fishing authorisations to vessels for the purpose of sport and recreational fishing. 2. For sport and recreational fisheries no more than one bluefin tuna shall be caught per vessel per day. 3. Any bluefin tuna landed shall be whole, gilled and/or gutted. Each Member State shall take the necessary measures to ensure, to the greatest extent possible, the release of bluefin tuna, especially juveniles, caught alive in the framework of sport and recreational fishing. 4. The marketing of bluefin tuna caught during sport and recreational fishing shall be prohibited. 5. Each Member State shall record catch data including weight and length of each bluefin tuna caught during sport and recreational fishing and communicate the data for the preceding year to the Commission by 30 June each year. The Commission shall forward that information to the SCRS. 6. Each Member State shall count dead catches from sport and recreational fisheries against the quota it allocated in accordance with Article 7(1) and Article 18. CHAPTER V CONTROL MEASURES SECTION 1 Records of vessels and traps Article 20 Records of vessels 1. Each Member State shall submit electronically each year to the Commission one month before the start of the fishing seasons referred to in Articles 11 and 12, where applicable, and otherwise one month before the start of the period of authorisation: (a) a list of all catching vessels flying its flag authorised to fish actively for bluefin tuna in the eastern Atlantic and the Mediterranean by the issuing of a fishing authorisation; (b) a list of all other fishing vessels, other than catching vessels, flying its flag authorised to operate for bluefin tuna in the eastern Atlantic and the Mediterranean. 2. Both lists shall be set up in accordance with the format set in the Guidelines by ICCAT for submitting the data and information required. 3. During a calendar year, a fishing vessel may be included in both of the lists referred to in paragraph 1 provided that it is not included in both lists at the same time. 4. The lists referred to in paragraph 1 of this Article shall contain the vessel's name and Union fleet register number (CFR) as defined in Annex I to Commission Regulation (EC) No 26/2004 (16). 5. No retroactive submission shall be accepted. Subsequent changes to the lists referred to in paragraph 1 during a calendar year shall only be accepted if the notified fishing vessel is prevented from participating due to legitimate operational reasons or force majeure. In such circumstances, the Member State concerned shall immediately inform the Commission of that fact, and shall provide: (a) full details of the fishing vessel(s) intended to replace a vessel included in the lists referred to in paragraph 1; and (b) a comprehensive account of the reasons justifying the replacement and any relevant supporting evidence or references. 6. The Commission shall send the information referred to in paragraphs 1 and 2 to the ICCAT Secretariat so that the vessels can be entered into the ICCAT record of catching vessels authorised to fish actively for bluefin tuna or in the ICCAT record of all other fishing vessels (catching vessels excluded) authorised to operate for bluefin tuna. 7. Article 8a(2), (6), (7) and (8) of Council Regulation (EC) No 1936/2001 (17) shall apply with the necessary modifications. Article 21 Relationship with Regulation (EC) No 1224/2009 The control measures provided for in this Chapter shall apply in addition to those provided for in Regulation (EC) No 1224/2009, except where otherwise provided for in this Chapter. Article 22 Fishing authorisations for vessels 1. Without prejudice to Article 16, Union fishing vessels not entered into the ICCAT records referred to in Article 20(1) shall not be authorised to fish for, retain on board, tranship, transport, transfer, process or land bluefin tuna in the eastern Atlantic and the Mediterranean. 2. The flag Member State shall withdraw the fishing authorisation for bluefin tuna and may require the vessel to proceed immediately to a port designated by it when the individual quota is deemed to be exhausted. Article 23 Records of traps authorised to fish for bluefin tuna 1. By 15 February each year, each Member State shall send to the Commission electronically a list of its traps authorised, by the issuing of a fishing authorisation, to fish for bluefin tuna in the eastern Atlantic and the Mediterranean. The list shall include the name of the traps and the register number and shall be set up in accordance with the format set in the Guidelines by ICCAT for submitting data and information required. 2. The Commission shall send the list to the ICCAT Secretariat so that those traps can be entered into the ICCAT record of traps authorised to fish for bluefin tuna. 3. Union traps that are not entered into the ICCAT record shall not be authorised to fish for, retain, transfer, cage or land bluefin tuna in the eastern Atlantic and the Mediterranean. 4. Article 8a(2), (4), (6), (7) and (8) of Regulation (EC) No 1936/2001 shall apply with the necessary modifications. Article 24 Joint fishing operation 1. Any joint fishing operation (‘JFO’) for bluefin tuna shall only be authorised with the consent of the flag Member State(s) concerned. To be authorised, each purse seiner shall be equipped to fish for bluefin tuna and have an individual quota. JFOs with other CPCs shall not be permitted. 2. Each Member State shall take the necessary measures to obtain the following information from its fishing vessels applying for an authorisation to take part in the JFO: (a) the duration; (b) the identity of the operators involved; (c) the individual vessels' quotas; (d) the allocation key between the fishing vessels for the catches involved; and (e) information on the farms of destination. 3. At least 15 days before the start of the operation, each Member State shall send the information referred to in paragraph 2 to the Commission in the format set out in Annex VI. The Commission shall forward that information to the ICCAT Secretariat and to the flag State of other fishing vessels participating in the JFO at least 10 days before the start of the operation. 4. In the case of force majeure, the deadline set out in paragraph 3 shall not apply for the information requested under point (e) of paragraph 2. In that case, Member States may submit to the Commission an update of that information as soon as possible, together with a description of the events constituting force majeure. The Commission shall forward that information to the ICCAT Secretariat. SECTION 2 Catches Article 25 Recording requirements 1. In addition to complying with Articles 14, 15, 23 and 24 of Regulation (EC) No 1224/2009, the master of a Union catching vessel shall, if applicable, enter into the logbook the information listed in Part A of Annex II to this Regulation. 2. Masters of Union towing vessels, auxiliary vessels and processing vessels shall record their activities in accordance with the requirements set out in Parts B, C and D of Annex II. Article 26 Catch reports sent by masters and trap operators 1. Masters of catching vessels fishing actively for bluefin tuna shall send to the authorities of the flag Member State daily information from logbooks, including the ICCAT register number, the vessel name, the beginning and end of the period of authorisation, date, time, location (latitude and longitude) and the weight and number of bluefin tuna caught in the Convention area. They shall send that information electronically in the format set out in Annex V during the whole period in which the vessel is authorised to fish bluefin tuna. 2. Masters of purse seiners shall produce daily reports as referred to in paragraph 1 on a fishing operation by fishing operation basis, including operations where the catch was zero. 3. The reports referred to in paragraphs 1 and 2 shall be transmitted by the operator to its flag Member State authorities on a daily basis for purse seiners and vessels over 24 metres by 9.00 GMT for the preceding day and for other catching vessels by Monday 24.00 (midnight) for the preceding week ending Sunday 24.00 (midnight) GMT. 4. Trap operators fishing actively for bluefin tuna shall send a daily catch report including the ICCAT register number, date, time, catches (weight and number of fish), including zero catches. They shall send that information within 48 hours electronically in the format set out in Annex V to their Member State authorities during the whole period they are authorised to fish bluefin tuna. 5. The Commission may adopt implementing acts laying down detailed rules for the recording and reporting of vessel and trap activities referred to in paragraphs 1 to 4 of this Article and Annex V. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(2). Article 27 Weekly and monthly catch reports sent by the Member States 1. Each Member State shall, upon receipt of the catch reports referred to in Article 26, promptly forward them electronically to the Commission and shall provide promptly to the Commission weekly catch reports for all catching vessels and traps in accordance with the format set out in Annex V. The Commission shall forward that information on a weekly basis to the ICCAT Secretariat in accordance with the format set out in the Guidelines for submitting data and information required by ICCAT. 2. Each Member State shall inform the Commission, before the 15th day of each month, of the quantities of bluefin tuna caught in the eastern Atlantic and the Mediterranean which have been landed, transhipped, trapped or caged during the preceding month by the fishing vessels or traps flying the flag of or registered in that Member State. The information provided shall be structured by gear type including by-catch, catches in sport and recreational fisheries and zero catches. The Commission shall promptly forward that information to the ICCAT Secretariat. Article 28 Information on quota exhaustion 1. In addition to the provisions of Article 34 of Regulation (EC) No 1224/2009, each Member State shall inform the Commission when the quota allocated to a gear group referred to in Article 11 or Article 12 of this Regulation is deemed to have reached 80 %. 2. In addition to the provisions of Article 35 of Regulation (EC) No 1224/2009, each Member State shall inform the Commission when the quota allocated to a gear group referred to in Article 11 or Article 12 of this Regulation or to a JFO or to a purse seiner is deemed to be exhausted. 3. The information referred to in paragraph 2 shall be accompanied by official documentation proving the fishing stop or the call back to port issued by the Member State for the fleet, the gear group, the JFO, or the vessels with an individual quota including a clear indication of the date and the time of the closure. Article 29 Yearly reporting of catches by the Member States 1. By 15 March each year, each Member State shall submit to the Commission detailed information on any bluefin tuna catches in the eastern Atlantic and the Mediterranean in the preceding fishing year. That information shall include: (a) the name and ICCAT number of each catching vessel; (b) the period of authorisation(s) for each catching vessel; (c) the total catches of each catching vessel including when the catch was zero throughout the period of authorisation(s); (d) the total number of days each catching vessel fished in the eastern Atlantic and the Mediterranean throughout the period of authorisation(s); and (e) the total catch of each catching vessel outside the period of authorisation (by-catch), including when the catch was zero. 2. For vessels not authorised to fish actively for bluefin tuna in the eastern Atlantic and the Mediterranean but which caught bluefin tuna as by-catch, the information to be submitted to the Commission at the same date as referred to in paragraph 1 shall include: (a) the name and ICCAT number or national registry number of the vessel, if not registered with ICCAT; and (b) the total catches of bluefin tuna. 3. Each Member State shall notify to the Commission any information on vessels not subject to paragraphs 1 and 2 but known or presumed to have fished for bluefin tuna in the eastern Atlantic and the Mediterranean. 4. The Commission shall transmit to the ICCAT Secretariat the information received under paragraphs 1, 2 and 3. SECTION 3 Landings and transhipments Article 30 Designated ports 1. Each Member State shall designate ports or places close to the shore (designated ports) where landing or transhipping operations of bluefin tuna are permitted. 2. For a port to be determined as a designated port, the port Member State shall specify permitted landing and transhipping times and places. 3. By 15 February of each year, each Member State shall transmit a list of designated ports to the Commission which shall transmit that information to the ICCAT Secretariat. 4. It shall be prohibited to land or tranship from fishing vessels any quantity of bluefin tuna fished in the eastern Atlantic and the Mediterranean at any place other than ports or places close to the shore designated by CPCs and Member States in accordance with paragraphs 1 and 2. Article 31 Landings 1. Article 17 of Regulation (EC) No 1224/2009 shall apply to masters of Union fishing vessels of 12 metres' length overall or more included in the list of vessels referred to in Article 20 of this Regulation. The prior arrival notification under Article 17 of Regulation (EC) No 1224/2009 shall be sent to the competent authority of the Member State (including the flag Member State) or CPC whose ports or landing facility they wish to use. 2. In addition, masters of Union fishing vessels under 12 metres' length overall included in the list of vessels referred to in Article 20 shall, at least four hours before the estimated time of arrival at the port, notify the competent authority of the Member State (including the flag Member State) or the CPC whose ports or landing facility they wish to use, at least of the following: (a) estimated time of arrival; (b) estimated quantity of bluefin tuna retained on board; and (c) information on the geographical area where the catches were taken. 3. Where Member States are authorised under applicable Union legislation to apply a shorter notification period than that referred to in paragraphs 1 and 2, the estimated quantities of bluefin tuna retained on board may be notified at the thus applicable time of notification prior to arrival. If the fishing grounds are less than four hours from the port, the estimated quantities of bluefin tuna retained on board may be modified at any time prior to arrival. 4. Authorities of the port Member State shall keep a record of all prior notifications for the current year. 5. All landings shall be controlled, in accordance with Article 55(2), by the relevant control authorities of the port Member State and a percentage shall be inspected based on a risk assessment system involving quota, fleet size and fishing effort. Full details of such control system adopted by each Member State shall be detailed in the annual inspection plan referred to in Article 53. That control system shall also apply to harvest operations. 6. In addition to Article 23(1) of Regulation (EC) No 1224/2009, after each trip, masters of a Union catching vessel, whatever the length of the vessel, shall submit a landing declaration to the competent authorities of the flag Member State and, if the landing has taken place in a port of another Member State or CPC, to the competent authorities of the port Member State or CPC concerned. 7. All landed catches shall be weighed. Article 32 Transhipment 1. Transhipment at sea of bluefin tuna in the Convention area shall be prohibited in all circumstances. 2. Fishing vessels shall only tranship bluefin tuna catches in designated ports under the conditions set out in Article 30. 3. The port Member State shall ensure full inspection coverage during all transhipping times and at all transhipping places. 4. Prior to entry into any port, the masters or representatives of the receiving fishing vessels shall, at least 48 hours before the estimated time of arrival, provide the competent authorities of the Member State or CPC whose port they want to use with the following: (a) estimated date and time of arrival, and port of arrival; (b) estimated quantity of bluefin tuna retained on board, and information on the geographical area where it was taken; (c) the name of the transhipping fishing vessel and its number in the ICCAT record of catching vessels authorised to fish actively for bluefin tuna or in the ICCAT record of other fishing vessels authorised to operate for bluefin tuna in the eastern Atlantic and the Mediterranean; (d) the name of the receiving fishing vessel, its number in the ICCAT record of catching vessels authorised to fish actively for bluefin tuna or in the ICCAT record of other fishing vessels authorised to operate for bluefin tuna in the eastern Atlantic and the Mediterranean; and (e) the tonnage and the geographical area of the catch of bluefin tuna to be transhipped. 5. Fishing vessels shall not be allowed to tranship unless they have obtained prior authorisation from their flag State. 6. Masters of transhipping fishing vessels shall, before the transhipment starts, inform their flag State of the following: (a) the quantities of bluefin tuna to be transhipped; (b) the date and port of the transhipment; (c) the name, registration number and flag of the receiving fishing vessel and its number in the ICCAT record of catching vessels authorised to fish actively for bluefin tuna or in the ICCAT record of other fishing vessels authorised to operate for bluefin tuna in the eastern Atlantic and the Mediterranean; and (d) the geographical area of the catch of bluefin tuna. 7. All transhipments shall be inspected by the competent Member State authorities at the designated port. Those authorities shall: (a) inspect the receiving fishing vessel on arrival and check the cargo and documentation related to the transhipment operation; (b) send a record of the transhipment to the flag State authority of the transhipping fishing vessel, within five days after the transhipment has ended. 8. By way of derogation from Articles 21 and 22 of Regulation (EC) No 1224/2009, masters of a Union fishing vessel shall, whatever the length of the vessel, complete and send the ICCAT transhipment declaration to the competent authorities of the Member State whose flag the fishing vessel is flying. The declaration shall be transmitted no later than 48 hours after the date of transhipment in port in accordance with the format set out in Annex III to this Regulation. SECTION 4 Transfer operations Article 33 Transfer authorisation 1. Before any transfer operation, the master of a catching vessel or towing vessel or the operator of the farm or trap where the transfer in question originates shall send to the competent authorities of the relevant Member State a prior notification of transfer indicating: (a) the name of the catching vessel, towing vessel, farm or trap and the ICCAT register number; (b) the estimated time of transfer; (c) the estimate of the quantity of bluefin tuna to be transferred; (d) information on the position (latitude/longitude) where the transfer will take place as well as the identifiable cage numbers; (e) the name of the receiving towing vessel, the number of cages towed and, where appropriate, the ICCAT register number; (f) the port, farm or cage of destination of the bluefin tuna. 2. For the purpose referred to in paragraph 1, a unique cage number shall be assigned to each cage. Numbers shall be issued with a unique numbering system that includes at least three alfa-code letters corresponding to the flag of the towing vessel followed by three numbers. 3. Catching vessels, towing vessels, farms or traps shall not be allowed to transfer unless they have obtained prior authorisation from the relevant Member State. The authorities of that Member State shall decide for each transfer operation whether to grant authorisation. For that purpose, a unique identification number shall, for each transfer operation, be assigned and communicated to the master of the fishing vessel, the trap operator or the farm operator, as appropriate. Where authorisation is granted, that number shall comprise the three-letter code of the Member State, the four numbers indicating the year, and the three letters ‘AUT’ (authorisation), followed by sequential numbers. Where authorisation is refused, the number shall comprise the three-letter code of the Member State, the four numbers indicating the year, and the three letters ‘NEG’ (non-authorisation), followed by sequential numbers. 4. In the event that fish die during the transfer operation, the relevant Member States and operators involved in the transfer shall proceed in accordance with Annex XII. 5. The transfer authorisation shall be granted or refused by the Member State responsible for the catching vessel, towing vessel, farm or trap, as appropriate, within 48 hours following the submission of the prior notification of transfer. 6. The authorisation for transfer by the relevant Member State shall not prejudge the authorisation of the caging operation. Article 34 Refusal of transfer authorisation 1. The Member State responsible for the vessel, trap or farm shall not authorise the transfer if, on receipt of the prior notification of transfer, it considers that: (a) the catching vessel or the trap that is declared to have caught the fish does not have sufficient quota; (b) the quantity of fish has not been duly reported by the catching vessel or the trap operator or has not been authorised to be caged, or has not been taken into account for the consumption of the quota that may be applicable; (c) the catching vessel or trap that is declared to have caught the fish is not authorised to fish for bluefin tuna; or (d) the towing vessel declared to be the one to receive the transfer of fish is not registered in the ICCAT record of all other fishing vessels (catching vessels excluded) authorised to operate for bluefin tuna, as referred to in point (b) of Article 20(1), or is not equipped with a VMS. 2. If the transfer is not authorised: (a) the Member State responsible for the catching vessel or trap shall issue a release order to the master of the catching vessel or to the operator of the trap or farm as appropriate and inform them that the transfer is not authorised and that the fish have to be released into the sea; (b) the master of the catching vessel, the farm operator or the trap operator, as appropriate, shall release the fish; (c) the release of bluefin tuna shall be carried out in accordance with the procedures set out in Annex XI. Article 35 Monitoring by video camera 1. For transfer operations, the master of the catching vessel, towing vessel, farm operator or trap operator that transfers bluefin tuna shall ensure that the transfer operations are monitored by video camera in the water in order to verify the number of fish being transferred. The minimum standards and procedures for video recording shall be in accordance with Annex IX. 2. Each Member State responsible for the vessel, trap or farm shall ensure that the video records referred to in paragraph 1 are made available to the ICCAT inspectors and regional observers. 3. Each Member State responsible for the vessel, trap or farm shall ensure that the video records referred to in paragraph 1 are made available to Union inspectors and national observers. 4. Each Member State responsible for the vessel, trap or farm shall take the necessary measures to avoid any replacement, editing or manipulation of the original video record. Article 36 Verification by ICCAT regional observers and launching and conduct of investigation 1. ICCAT regional observers on board the catching vessel or present at a trap, as set out in Article 51 and Annex VII, shall record and report on the transfer operations carried out, observe and estimate catches transferred and verify entries made in the prior transfer authorisation referred to in Article 33 and in the ICCAT transfer declaration referred to in Article 38. 2. In cases where there is more than 10 % difference by number between the estimates of catch made by the ICCAT regional observer, relevant control authorities and/or the master of the catching vessel, or representative of the trap, or where the video record is of insufficient quality or clarity to make such estimations, the Member State responsible for the catching vessel, farm or trap shall launch an investigation which shall be concluded prior to the time of caging at the farm or in any case within 96 hours after being launched. Pending the results of that investigation, caging shall not be authorised and the catch section of the bluefin tuna catch document (‘BCD’) shall not be validated. 3. However, when the video record is of insufficient quality or clarity to estimate the number, the operator may request authorisation from the flag State authorities of the vessel, trap or farm to conduct a new transfer operation and to provide the corresponding video record to the ICCAT regional observer. 4. Without prejudice to the verifications conducted by an inspector, ICCAT regional observers shall sign the ICCAT transfer declaration only when their observations are in accordance with the ICCAT conservation and management measures and when the information contained in the transfer declaration is consistent with their observations including a compliant video record as required under Article 35(1). They shall sign that declaration with clearly written name and ICCAT number. 5. ICCAT regional observers shall also verify that the ICCAT transfer declaration is transmitted to the master of the towing vessel or to the farm or trap representative. Article 37 Measures to estimate the number and weight of bluefin tuna to be caged Member States shall take the necessary measures and actions to further explore methodologies to improve the estimate of both the number and weight of bluefin tuna at the point of capture and caging. Each Member State shall report on the measures taken by 22 August of each year to the Commission who shall submit those reports to the SCRS. Article 38 Transfer declaration 1. Masters of catching or towing vessels, trap operators or farm operators shall, at the end of the transfer operation, complete and transmit to the competent authorities of their Member State the ICCAT transfer declaration, in accordance with the format set out in Annex IV. 2. Transfer declaration forms shall be numbered by the competent authorities of the Member State responsible for the vessels, farms or traps from which the transfers originate. The numbering system shall include the three-letter code of the Member State, followed by the four numbers indicating the year and three sequential numbers followed by the three letters ‘ITD’ (MS-20**/xxx/ITD). 3. The original transfer declaration shall accompany the transfer of the fish. A copy of the declaration shall be kept by the master of the catching vessel, the trap operator, the master of the towing vessel or the farm operator. 4. Masters of vessels carrying out transfer operations (including towing vessels) shall report their activities in accordance with the requirements set out in Annex II. Article 39 Implementing acts The Commission may adopt implementing acts laying down detailed rules for transfer operations referred to in Articles 33 to 38 and the Annexes referred to in those Articles. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(2). SECTION 5 Caging operations Article 40 Caging authorisation 1. Prior to the start of each caging operation the anchoring of transport cages within 0,5 nautical miles of farming facilities shall be prohibited. 2. Before any caging operation, the competent authority of the Member State responsible for the farm shall inform the Member State or CPC responsible for the catching vessel or trap of the quantities caught by that vessel or trap and request a caging authorisation. 3. The caging operation shall not begin without the prior authorisation by: (a) the Member State or CPC responsible for the catching vessel or trap; or (b) the Member State or CPC responsible for the farm if it has been agreed among the Member States involved or with the flag CPC involved. 4. The caging authorisation shall be granted or refused by the Member State or CPC responsible for the catching vessel, trap or, if applicable, farm, within one working day following the request and the submission of the information referred to in paragraph 2. If no response is received within one working day from the Member State or CPC responsible for the catching vessel or trap, the Member State or CPC responsible for the farm may authorise the caging. 5. Bluefin tuna shall be caged before 15 August, unless the Member State or CPC responsible for the farm receiving the fish provides duly justified reasons. Such reasons shall be submitted with the caging report. Article 41 Refusal of caging authorisation 1. The Member State responsible for the catching vessel, trap or, if applicable, farm, shall refuse the caging authorisation if it considers, on receipt of the information referred to in Article 40(2), that: (a) the catching vessel or trap that is declared to have caught the fish did not have sufficient quota for the bluefin tuna that were put into the cage; (b) the quantity of fish has not been duly reported by the catching vessel or trap or has not been taken into account for the calculation of the quota applicable; or (c) the catching vessel or trap that is declared to have caught the fish is not authorised to fish for bluefin tuna. 2. If the caging is not authorised, the Member State or CPC responsible for the catching vessel shall request the Member State or CPC responsible for the farm to seize the catches and to release the fish by issuing a release order. 3. Upon receipt of the release order, the farm operator shall proceed with the releases in accordance with Annex XI. Article 42 Bluefin tuna catch documentation Member States responsible for farms shall prohibit any placing of bluefin tuna in cages for the purpose of farming that is not accompanied by the documentation required by ICCAT and in accordance with Regulation (EU) No 640/2010 of the European Parliament and of the Council (18). The documentation shall be accurate, complete and confirmed and validated by the Member State or CPC authorities of the catching vessels or traps. Article 43 Inspections Member States responsible for farms shall take the necessary measures to inspect each caging operation in the farms. Article 44 Monitoring by video camera 1. Each Member State responsible for the farm shall ensure that caging operations are monitored by video camera in the water. A video record shall be produced for each caging operation in accordance with Annex IX. 2. Each Member State responsible for the farm shall ensure that the video records referred to in paragraph 1 are made available to the ICCAT inspectors and regional observers. 3. Each Member State responsible for the farm shall ensure that the video records referred to in paragraph 1 are made available to Union inspectors and national observers. 4. Each Member State responsible for the farm shall take the necessary measures to avoid any replacement, editing or manipulation of the original video record. Article 45 Launching and conduct of investigations 1. Where there is a difference of more than 10 % in the number of bluefin tuna between the estimates made by the ICCAT regional observer, the relevant Member State control authorities or the farm operator, the Member State responsible for the farm shall, in cooperation with the Member State or CPC responsible for the catching vessel or trap, launch an investigation. 2. Pending the results of that investigation, harvesting shall not take place and the farming section of the BCD shall not be validated. 3. The Member States responsible for the farm and for the catching vessel or trap which undertake the investigations may use other information at their disposal including the results of the programmes referred to in Article 46 to conclude the investigation. Article 46 Measures and programmes to estimate the number and weight of bluefin tuna to be caged 1. Member States shall take the necessary measures and actions as referred to in Article 37. 2. A programme using stereoscopic camera systems or alternative techniques that provide the equivalent precision shall cover 100 % of the caging operations in order to refine the number and weight of the fish in each caging operation. 3. That programme shall be implemented in accordance with the procedures set out in Section B of Annex X. 4. The results of that programme shall be communicated by the Member State responsible for the farm to the Member State or CPC responsible for the catching vessel or trap and to the Commission in accordance with Section B of Annex X. The Commission shall transmit them to the ICCAT Secretariat for transmission to the ICCAT regional observer. 5. When the results of the programme indicate that the quantities of bluefin tuna being caged differ from the quantities reported caught and transferred, the Member State responsible for the farm shall, in cooperation with the Member State or CPC responsible for the catching vessel or trap, launch an investigation. If the investigation is not concluded within 10 working days from the communication of the results referred to in paragraph 4 of this Article or if the outcome of the investigation indicates that the number or average weight of bluefin tuna is in excess of that reported caught and transferred, the flag Member State or CPC authorities of the catching vessel or trap shall issue a release order for the excess which must be released in accordance with the procedures laid down in Annex XI. 6. In accordance with the procedures set out in point 3 of Section B of Annex X and following the release, if applicable, the quantities derived from the programme shall be used to: (a) determine the final catch figures to be deducted from the national quota; (b) fill in those figures in the caging declarations and relevant sections of the BCD. 7. Each Member State responsible for the farm shall report on the results of those programmes by 30 August of each year to the Commission who shall submit those reports to the SCRS. 8. The transfer of live bluefin tuna from one farming cage to another farming cage shall not take place without the authorisation and the presence of the farm state control authorities. 9. A difference superior or equal to 10 % between the quantities of bluefin tuna reported caught by the vessel/trap and the quantities established by the control cameras, as referred to in paragraph 5 of this Article and Article 45, shall constitute a potential non-compliance by the vessel/trap concerned and Member States shall take the necessary measures to ensure the appropriate follow-up. Article 47 Caging report 1. Within one week of the completion of the caging operation, the Member State responsible for the farm shall submit a caging report containing the elements set up in Section B of Annex X to the Member State or CPC whose vessels or traps have caught the bluefin tuna, and to the Commission. The report shall also contain the information included in the caging declaration as set out in Article 4b of and Annex Ia to Regulation (EC) No 1936/2001. The Commission shall forward the report to the ICCAT Secretariat. 2. For the purposes of paragraph 1, a caging operation shall not be deemed to be completed until any investigation launched and, if applicable, any release operation ordered, is concluded. Article 48 Implementing acts The Commission may adopt implementing acts laying down detailed rules for caging operations referred to in Articles 40 to 47 and the Annexes referred to in those Articles. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(2). SECTION 6 Monitoring and surveillance Article 49 Vessel monitoring system 1. By way of derogation from Article 9(2) of Regulation (EC) No 1224/2009, the obligation concerning the VMS shall apply to all tug and towing vessels included in the ICCAT record of vessels referred to in Article 20(6) of this Regulation, irrespective of their length. 2. Fishing vessels over 15 metres length that are included in the list of vessels referred to in point (a) of Article 20(1) or in the list of vessels referred to in point (b) of Article 20(1) shall begin to transmit VMS data to ICCAT at least 15 days before the opening of the fishing season and shall continue to transmit those data for at least 15 days after the closure of the fishing season, unless a request is sent in advance to the Commission for the vessel to be removed from the ICCAT record of vessels. 3. For control purposes, the transmission of VMS data from catching vessels that are authorised to fish actively for bluefin tuna shall not be interrupted when vessels are in port. 4. Member States shall ensure that their fisheries monitoring centres forward to the Commission and a body designated by it, in real time and using the format ‘https data feed’, the VMS messages received from the fishing vessels flying their flag. The Commission shall send those messages electronically to the ICCAT Secretariat. 5. Member States shall ensure that: (a) VMS messages from the fishing vessels flying their flag are forwarded to the Commission at least every two hours; (b) in the event of technical malfunction of the VMS, alternative messages from the fishing vessels flying their flag received under Article 25(1) of Implementing Regulation (EU) No 404/2011 are forwarded to the Commission within 24 hours of receipt by their fisheries monitoring centres; (c) messages forwarded to the Commission are sequentially numbered (with a unique identifier) in order to avoid duplication; (d) messages forwarded to the Commission are in accordance with Article 24(3) of Implementing Regulation (EU) No 404/2011. 6. Each Member State shall take the necessary measures to ensure that all messages made available to its inspection vessels are treated in a confidential manner and are limited to inspection at sea operations. Article 50 National observer programme 1. In respect of vessels active in the bluefin tuna fishery, Member States shall ensure at least the following percentage levels of national observer coverage: (a) 20 % of its pelagic trawlers (over 15 metres); (b) 20 % of its long line vessels (over 15 metres); (c) 20 % of its bait boats (over 15 metres); (d) 100 % of towing vessels; (e) 100 % of harvesting operations from traps. 2. Member States shall issue national observers with an official identification document. 3. The national observer tasks shall be, in particular, to: (a) monitor compliance by fishing vessels and traps with this Regulation; (b) record, and report upon, the fishing activity which shall include the following: (i) amount of catch (including by-catch) that also includes species disposition, such as retained on board or discarded dead or alive; (ii) area of catch by latitude and longitude; (iii) measure of effort (such as the number of sets, number of hooks), as defined in the ICCAT Field Manual for different gears; (iv) date of catch; (c) observe and estimate catches and verify entries made in the logbook; (d) sight and record vessels which may be fishing contrary to ICCAT conservation and management measures. 4. National observers shall also carry out scientific work, such as collecting Task II data as defined by ICCAT, when required by ICCAT, based on the instructions from the SCRS. 5. For the purposes of paragraphs 1 to 4, each Member State shall also ensure: (a) representative temporal and spatial presence of national observers on its vessels and traps to ensure that the Commission receives adequate and appropriate data and information on catch, effort and other scientific and management aspects, taking into account characteristics of the fleets and fisheries; (b) robust data collection protocols; (c) that national observers are properly trained and approved before deployment; (d) to the extent possible, minimal disruption to the operations of fishing vessels and traps fishing in the Convention Area. 6. Data and information collected under each Member State's observer programme shall be provided to the Commission by 15 July each year. The Commission shall forward that data and information to the SCRS and the ICCAT Secretariat, as appropriate. Article 51 ICCAT regional observer programme 1. The ICCAT regional observer programme as set out in paragraphs 2 to 6 and as further specified in Annex VII shall apply in the Union. 2. Member States shall ensure that an ICCAT regional observer is present: (a) on all purse seiners authorised to fish bluefin tuna; (b) during all transfers of bluefin tuna from purse seiners; (c) during all transfers of bluefin tuna from traps to transport cages; (d) during all transfers from one farm to another; (e) during all caging operations of bluefin tuna in farms; (f) during all harvesting of bluefin tuna from farms. 3. Purse seiners without an ICCAT regional observer shall not be authorised to fish or to operate in the bluefin tuna fishery. 4. Member States responsible for farms shall ensure an ICCAT regional observer's presence during all caging operations and all harvesting of fish from those farms. 5. The tasks of ICCAT regional observers shall be, in particular, to: (a) observe and monitor that fishing and farming operations are in compliance with the relevant ICCAT conservation and management measures; (b) sign the ICCAT transfer declarations referred to in Article 38, caging reports referred to in Article 47 and BCDs when they agree that the information contained therein is consistent with their observations; (c) carry out scientific work, such as collecting samples, as required by ICCAT, based on the instructions from the SCRS. 6. The flag Member State shall ensure that masters, crew, farm, trap and vessel owners do not obstruct, intimidate, interfere with, influence, bribe or attempt to bribe ICCAT regional observers in the performance of their duties. SECTION 7 Inspections and cross-checks Article 52 ICCAT Scheme of Joint International Inspection 1. The ICCAT Scheme of Joint International Inspection (‘the ICCAT scheme’) set out in Annex VIII shall apply in the Union. 2. Member States whose fishing vessels are authorised to fish bluefin tuna in the eastern Atlantic and the Mediterranean shall assign inspectors and carry out inspections at sea under the ICCAT scheme. 3. If, at any time, more than 15 fishing vessels flagged to a Member State are engaged in bluefin tuna fishing activities in the Convention area, that Member State shall deploy an inspection vessel for the purpose of inspection and control at sea in the Convention area throughout the period that those vessels are there. That obligation shall be deemed to have been complied with where Member States cooperate to deploy an inspection vessel or where a Union inspection vessel is deployed in the Convention area. 4. The Commission or a body designated by it may assign Union inspectors to the ICCAT scheme. 5. The Commission or a body designated by it shall coordinate the surveillance and inspection activities for the Union. The Commission may draw up, in coordination with the Member States concerned, joint inspection programmes to enable the Union to fulfil its obligation under the ICCAT scheme. Member States whose fishing vessels are engaged in the fishery of bluefin tuna shall adopt the necessary measures to facilitate the implementation of those programmes particularly as regards the human and material resources required and the periods and geographical areas when those resources are to be deployed. 6. Member States shall inform the Commission by 1 April of each year of the names of the inspectors and the inspection vessels they intend to assign to the ICCAT scheme during the year. Using that information, the Commission shall draw up, in collaboration with the Member States, a plan for the Union participation in the ICCAT scheme each year, which it shall send to the ICCAT Secretariat and the Member States. Article 53 Transmission of inspection plans 1. By 31 January each year, Member States shall transmit their inspection plans to the Commission. The inspection plans shall be set up in accordance with: (a) the objectives, priorities, and procedures as well as benchmarks for inspection activities set up in the Specific control and inspection programme for bluefin tuna in the eastern Atlantic and the Mediterranean established under Article 95 of Regulation (EC) No 1224/2009; (b) the National control action programme for bluefin tuna in the eastern Atlantic and the Mediterranean established under Article 46 of Regulation (EC) No 1224/2009. 2. The Commission shall compile the national inspection plans and integrate them into the Union inspection plan. That plan shall be transmitted by the Commission to the ICCAT Secretariat, for endorsement by ICCAT, together with the plans referred to in Article 6(1). Article 54 Inspections in case of infringements 1. The flag Member State shall take the action under paragraph 2 of this Article if a vessel flying its flag has: (a) failed in its reporting requirement referred to in Articles 25 and 26; or (b) committed an infringement of the provisions of this Regulation, Articles 89 to 93 of Regulation (EC) No 1224/2009 or Chapter IX of Regulation (EC) No 1005/2008. 2. The flag Member State shall ensure that a physical inspection takes place under its authority in its ports or by another person designated by the flag Member State when the vessel is not in one of its ports. Article 55 Cross-check 1. Each Member State shall verify, including by using inspection reports, observer reports and VMS data, the submission of logbooks and relevant information recorded in the logbooks of its fishing vessels, transfer or transhipment documents and BCDs, in accordance with Article 109 of Regulation (EC) No 1224/2009. 2. Each Member State shall carry out cross-checks on all landings, transhipments or cagings between the quantities by species recorded in the fishing vessels logbook or quantities by species recorded in the transfer or transhipment declaration and the quantities recorded in the landing declaration or caging declaration, and any other relevant document, such as an invoice and/or sales notes, in accordance with Article 109 of Regulation (EC) No 1224/2009. SECTION 8 Marketing Article 56 Marketing measures 1. Without prejudice to Regulations (EC) No 1224/2009, (EC) No 1005/2008 and Regulation (EU) No 1379/2013 of the European Parliament and of the Council (19), Union trade, landing, import, export, placing in cages for fattening or farming, re-export and transhipment of bluefin tuna that are not accompanied by accurate, complete and validated documentation set out in this Regulation, Regulation (EU) No 640/2010 and Article 4b of Regulation (EC) No 1936/2001, shall be prohibited. 2. Union trade, import, landing, placing in cages for fattening or farming, processing, export, re-export and transhipment of bluefin tuna shall be prohibited if: (a) the bluefin tuna was caught by fishing vessels or traps whose flag State does not have a quota, catch limit or allocation of fishing effort for bluefin tuna in the eastern Atlantic and the Mediterranean, under the terms of ICCAT conservation and management measures; or (b) the bluefin tuna was caught by a fishing vessel or a trap whose individual quota or whose state's fishing opportunities were exhausted at the time of the catch. 3. Without prejudice to Regulations (EC) No 1224/2009, (EC) No 1005/2008 and (EU) No 1379/2013, Union trade, imports, landings, processing and exports of bluefin tuna from fattening or farming farms that do not comply with the Regulations referred to in paragraph 1 shall be prohibited. CHAPTER VI FINAL PROVISIONS Article 57 Evaluation Member States shall submit to the Commission by 15 September each year a detailed report on their implementation of this Regulation. Based on the information received from Member States, the Commission shall submit by 15 October each year to the ICCAT Secretariat a detailed report on the implementation of ICCAT Recommendation 14-04. Article 58 Financing For the purposes of Regulation (EU) No 508/2014 of the European Parliament and of the Council (20), the multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean shall be deemed to be a multiannual plan within the meaning of Article 9 of Regulation (EU) No 1380/2013. Article 59 Implementation 1. The Commission shall be assisted by the Committee for Fisheries and Aquaculture established by Article 47 of Regulation (EU) No 1380/2013. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 60 Repeal 1. Regulation (EC) No 302/2009 is hereby repealed. 2. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex XIII. Article 61 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 14 September 2016. For the European Parliament The President M. SCHULZ For the Council The President I. KORČOK (1) OJ C 383, 17.11.2015, p. 100. (2) Position of the European Parliament of 23 June 2016 (not yet published in the Official Journal) and decision of the Council of 18 July 2016. (3) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). (4) International Convention for the Conservation of Atlantic Tunas (OJ L 162, 18.6.1986, p. 34). (5) Council Regulation (EC) No 1559/2007 of 17 December 2007 establishing a multi-annual recovery plan for bluefin tuna in the Eastern Atlantic and Mediterranean and amending Regulation (EC) No 520/2007 (OJ L 340, 22.12.2007, p. 8). (6) Council Regulation (EC) No 302/2009 of 6 April 2009 concerning a multiannual recovery plan for bluefin tuna in the eastern Atlantic and Mediterranean, amending Regulation (EC) No 43/2009 and repealing Regulation (EC) No 1559/2007 (OJ L 96, 15.4.2009, p. 1). (7) Regulation (EU) No 500/2012 of the European Parliament and of the Council of 13 June 2012 amending Council Regulation (EC) No 302/2009 concerning a multiannual recovery plan for bluefin tuna in the eastern Atlantic and Mediterranean (OJ L 157, 16.6.2012, p. 1). (8) Regulation (EU) No 544/2014 of the European Parliament and of the Council of 15 May 2014 amending Council Regulation (EC) No 302/2009 concerning a multiannual recovery plan for Bluefin tuna in the eastern Atlantic and Mediterranean (OJ L 163, 29.5.2014, p. 7). (9) Commission Delegated Regulation (EU) 2015/98 of 18 November 2014 on the implementation of the Union's international obligations, as referred to in Article 15(2) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council, under the International Convention for the Conservation of Atlantic Tunas and the Convention on Future Multilateral Cooperation in the Northwest Atlantic Fisheries (OJ L 16, 23.1.2015, p. 23). (10) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (11) Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1). (12) Commission Implementing Regulation (EU) No 404/2011 of 8 April 2011 laying down detailed rules for the implementation of Council Regulation (EC) No 1224/2009 establishing a Community control system for ensuring compliance with the rules of the Common Fisheries Policy (OJ L 112, 30.4.2011, p. 1). (13) Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1). (14) Commission Implementing Decision 2014/156/EU of 19 March 2014 establishing a specific control and inspection programme for fisheries exploiting stocks of bluefin tuna in the Eastern Atlantic and the Mediterranean, swordfish in the Mediterranean and for fisheries exploiting stocks of sardine and anchovy in the Northern Adriatic Sea (OJ L 85, 21.3.2014, p. 15). (15) Report of the Inter-sessional meeting of the Compliance Committee (Madrid, Spain, 24 to 26 February 2010), point 5 and Appendix 3 to Annex 4.2. (16) Commission Regulation (EC) No 26/2004 of 30 December 2003 on the Community fishing fleet register (OJ L 5, 9.1.2004, p. 25). (17) Council Regulation (EC) No 1936/2001 of 27 September 2001 laying down control measures applicable to fishing for certain stocks of highly migratory fish (OJ L 263, 3.10.2001, p. 1). (18) Regulation (EU) No 640/2010 of the European Parliament and of the Council of 7 July 2010 establishing a catch documentation programme for bluefin tuna Thunnus thynnus and amending Council Regulation (EC) No 1984/2003 (OJ L 194, 24.7.2010, p. 1). (19) Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products, amending Council Regulations (EC) No 1184/2006 and (EC) No 1224/2009 and repealing Council Regulation (EC) No 104/2000 (OJ L 354, 28.12.2013, p. 1). (20) Regulation (EU) No 508/2014 of the European Parliament and of the Council of 15 May 2014 on the European Maritime and Fisheries Fund and repealing Council Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006 and (EC) No 791/2007 and Regulation (EU) No 1255/2011 of the European Parliament and of the Council (OJ L 149, 20.5.2014, p. 1). ANNEX I Specific conditions applicable to the fisheries referred to in Article 14(2) 1. In addition to the provisions set out in Article 9(3), the maximum number of baitboats and trolling boats authorised to fish for bluefin tuna in the eastern Atlantic under the specific conditions applying to the derogation referred to in point (a) of Article 14(2) is set at the number of Union catching vessels participating in the directed fishery for bluefin tuna in 2006. 2 In addition to the provisions set out in Article 9(3), the maximum number of catching vessels authorised to fish for bluefin tuna in the Adriatic sea for farming purposes under the specific conditions applying to the derogation referred to in point (b) of Article 14(2) is set at the number of Union catching vessels participating in the directed fishery for bluefin tuna in 2008. For that purpose, the number of Croatian catching vessels participating in the directed fishery for bluefin tuna in 2008 shall be taken into account. 3. In addition to the provisions set out in Article 9(3), the maximum number of baitboats, longliners and handliners authorised to fish for bluefin tuna in the Mediterranean under the specific conditions applying to the derogation referred to in point (c) of Article 14(2) is set at the number of Union catching vessels participating in the directed fishery for bluefin tuna in 2008. 4. The maximum number of catching vessels determined in accordance with points 1, 2 and 3 of this Annex shall be allocated among the Member States in accordance with the TFEU and Article 16 of Regulation (EU) No 1380/2013. 5. No more than 7 % of the Union quota for bluefin tuna between 8 kg or 75 cm and 30 kg or 115 cm shall be allocated among the authorised catching vessels referred to in point (a) of Article 14(2) and in point 1 of this Annex. That quota shall be allocated among Member States in accordance with the TFEU and Article 16 of Regulation (EU) No 1380/2013. 6. By way of derogation from point (a) of Article 14(2), within the quota of 7 % referred to in point 5 of this Annex, up to 100 tonnes may be allocated for the capture of bluefin tuna of no less than 6,4 kg or 70 cm by baitboats of less than 17 metres. 7. The maximum allocation of the Union quota among Member States to fish under the specific conditions applying to the derogation referred to in point (b) of Article 14(2) and point 2 of this Annex shall be determined in accordance with the TFEU and Article 16 of Regulation (EU) No 1380/2013. 8. No more than 2 % of the Union quota for bluefin tuna between 8 kg or 75 cm and 30 kg or 115 cm shall be allocated among the authorised catching vessels referred to in point (c) of Article 14(2) and point 3 of this Annex. That quota shall be allocated among Member States in accordance with the TFEU and Article 16 of Regulation (EU) No 1380/2013. 9. Each Member State whose baitboats, longliners, handliners and trolling boats are authorised to fish for bluefin tuna in accordance with Article 14(2) and this Annex shall establish the following tail tag requirements: (a) tail tags are affixed on each bluefin tuna immediately upon offloading; (b) each tail tag has a unique identification number which is included in bluefin tuna statistical documents and written on the outside of any package containing tuna. ANNEX II Logbook requirements A. CATCHING VESSELS Minimum specifications for fishing logbooks: 1. The logbook shall be numbered by sheet. 2. The logbook shall be completed every day (midnight) or before port arrival. 3. The logbook shall be completed in case of at-sea inspections. 4. One copy of the sheets shall remain attached to the logbook. 5. Logbooks shall be kept on board to cover a period of one year of operation. Minimum standard information for fishing logbooks: 1. Master's name and address. 2. Dates and ports of departure, dates and ports of arrival. 3. Vessel's name, register number, ICCAT number, international radio call sign and IMO number (if available). 4. Fishing gear: (a) type FAO code; (b) dimension (e.g. length, mesh size, number of hooks). 5. Operations at sea with one line (minimum) per day of trip, providing: (a) activity (e.g. fishing, steaming); (b) position: exact daily positions (in degree and minutes), recorded for each fishing operation or at midday when no fishing has been conducted during that day; (c) record of catches, including: (1) FAO code; (2) round (RWT) weight in kg per day; (3) number of pieces per day. For purse seiners that should be recorded by fishing operation, including nil return. 6. Master's signature. 7. Means of weight measure: estimation, weighing on board. 8. The logbook shall be kept in equivalent live weight of fish and shall mention the conversion factors used in the evaluation. Minimum information for fishing logbooks in case of landing or transhipment: 1. Dates and port of landing/transhipment. 2. Products: (a) species and presentation by FAO code; (b) number of fish or boxes and quantity in kg. 3. Signature of the master or vessel agent. 4. In case of transhipment: receiving vessel name, its flag and ICCAT number. Minimum information for fishing logbooks in case of transfer into cages: 1. Date, time and position (latitude/longitude) of transfer. 2. Products: (a) species identification by FAO code; (b) number of fish and quantity in kg transferred into cages. 3. Name of towing vessel, its flag and ICCAT number. 4. Name of the farm of destination and its ICCAT number. 5. In the case of a JFO, in addition to the information laid down in points 1 to 4, the masters shall record in their logbook: (a) as regards the catching vessel transferring the fish into cages: — amount of catches taken on board, — amount of catches counted against its individual quota, — the names of the other vessels involved in the JFO; (b) as regards the other catching vessels of the same JFO not involved in the transfer of the fish: — the name of those vessels, their international radio call signs and ICCAT numbers, — that no catches have been taken on board or transferred into cages, — amount of catches counted against their individual quotas, — the name and the ICCAT number of the catching vessel referred to in point (a). B. TOWING VESSELS 1. The master of a towing vessel shall record in the daily logbook the date, time and position of transfer, the quantities transferred (number of fish and quantity in kg), the cage number, as well as the catching vessel's name, flag and ICCAT number, the name of the other vessel(s) involved and their ICCAT number, the farm of destination and its ICCAT number, and the ICCAT transfer declaration number. 2. Further transfers to auxiliary vessels or to other towing vessel shall be reported, including the same information as in point 1, as well as the auxiliary or towing vessel's name, flag and ICCAT number and the ICCAT transfer declaration number. 3. The daily logbook shall contain the details of all transfers carried out during the fishing season. The daily logbook shall be kept on board and be accessible at any time for control purposes. C. AUXILIARY VESSELS 1. The master of an auxiliary vessel shall record the activities daily in the logbook, including the date, time and positions, the quantities of bluefin tuna taken on board, and the fishing vessel, farm or trap name he/she is operating in association with. 2. The daily logbook shall contain the details of all activities carried out during the fishing season. The daily logbook shall be kept on board and be accessible at any time for control purposes. D. PROCESSING VESSELS 1. The master of a processing vessel shall report in the daily logbook the date, time and position of the activities and the quantities transhipped and the number and weight of bluefin tuna received from farms, traps or catching vessels, where applicable. The master should also report the names and ICCAT numbers of those farms, traps or catching vessels. 2. The master of a processing vessel shall maintain a daily processing logbook specifying the round weight and number of fish transferred or transhipped, the conversion factor used, and the weights and quantities by product presentation. 3. The master of a processing vessel shall maintain a stowage plan that shows the location and the quantities of each species and presentation. 4. The daily logbook shall contain the details of all transhipments carried out during the fishing season. The daily logbook, processing logbook, stowage plan and the originals of ICCAT transhipment declarations shall be kept on board and be accessible at any time for control purposes. ANNEX III ICCAT Transhipment Declaration Text of image Document No Carrier vessel Name of vessel and radio call sign: Flag: Flag State authorisation No National Register No ICCAT Register No IMO No Fishing Vessel Name of the vessel and radio call sign: Flag: Flag State authorisation No. National Register No. ICCAT Register No. External identification: Fishing logbook sheet No Final destination: Port: Country: State: Day Month Hour Year |2_|0_||| F.V Master’s name: Carrier vessel Master’s name: Departure ||| ||| ||| From: || Return ||| ||| ||| To: || Signature: Signature: Tranship. ||| ||| ||| || For transhipment, indicate the weight in kilograms or the unit used (e.g. box, basket) and the landed weight in kilograms of this unit: || kilograms. Text of image LOCATION OF TRANSHIPMENT Port Sea Species Number of unit of fish Type of product live Type of product whole Type of product gutted Type of product head off Type of product filleted Type of product Further transhipments Date: || Place/Position: || Authorisation CP No Transfer vessel Master’s signature: Name of receiver vessel: Flag ICCAT Register No IMO No Master’s signature Date: || Place/Position: || Authorisation CP No Transfer vessel Master’s signature: Name of receiver vessel: Flag ICCAT Register No IMO No Master’s signature Lat. Long. Obligations in case of transhipment: 1. The original of the transhipment declaration shall be provided to the recipient vessel (processing/transport). 2. The copy of the transhipment declaration shall be kept by the correspondent catching vessel or trap. 3. Further transhipping operations shall be authorised by the relevant CPC which authorised the vessel to operate. 4. The original of the transhipment declaration has to be kept by the recipient vessel which holds the fish, up to the landing place. 5. The transhipping operation shall be recorded in the logbook of any vessel involved in the operation. ANNEX IV Text of image Document No ICCAT Transfer Declaration 1. TRANSFER OF LIVE BFT DESTINATED FOR FARMING Fishing vessel name: Call sign: Flag: Flag State transfer authorisation No ICCAT Register No External identification: Fishing logbook No JFO No Trap name: ICCAT Register No Tug vessel name: Call sign: Flag: ICCAT Register No: External identification: Name of destination farm: ICCAT Register No: Cage number: 2. TRANSFER INFORMATION Date: _ _ / _ _ / _ _ _ _ Place or position: Port: Lat: Long: Number of individuals: Species: Weight: Type of product: Live Whole Gutted Other (Specify): Master of fishing vessel trap operator/farm operator name and signature: Master of receiver vessel (tug, processing, carrier) name and signature: Observer names, ICCAT No and signature: 3. FURTHER TRANSFERS Date: _ _ / _ _ / _ _ _ _ Place or position: Port: Lat: Long: Tug vessel name: Call sign: Flag: ICCAT Register No Farm state transfer authorisation No: External identification: Master of receiver vessel name and signature: Text of image Date: _ _ / _ _ / _ _ _ _ Place or position: Port: Lat: Long: Tug vessel name: Call sign: Flag: ICCAT Register No Farm state transfer authorisation no: External identification: Master of receiver vessel name and signature: Date: _ _ / _ _ / _ _ _ _ Place or position: Port: Lat: Long: Tug vessel name: Call sign: Flag: ICCAT Register No Farm state transfer authorisation No: External identification: Master of receiver vessel name and signature: 4. SPLIT CAGES Donor cage No Kg: No of fish: Donor tug vessel name: Call sign: Flag: ICCAT Register No Receiving cage No Kg: No of fish: Receiving tug vessel name: Call sign: Flag: ICCAT Register No Receiving cage No Kg: No of fish: Receiving tug vessel name: Call sign: Flag: ICCAT Register No Receiving cage No Kg: No of fish: Receiving tug vessel name: Call sign: Flag: ICCAT Register No ANNEX V Catch report form Flag ICCAT Number Vessel name Report start date Report end date Report duration (d) Catch date Location of the catch Catch Attributed weight in case of a joint fishing operation (kg) Latitude Longitude Weight (kg) Number of pieces Average weight (kg) ANNEX VI Joint fishing operation Flag State Vessel name ICCAT No Duration of the operation Identity of the operators Vessel's individual quota Allocation key per vessel Fattening and farming farm destination CPC ICCAT No Date … Validation of the flag State … ANNEX VII ICCAT regional observer programme ASSIGNMENT OF ICCAT REGIONAL OBSERVERS 1. Each ICCAT regional observer shall have the following qualifications to accomplish their tasks: (a) sufficient experience to identify species and fishing gear; (b) satisfactory knowledge of the ICCAT conservation and management measures assessed by a certificate provided by the Member States and based on ICCAT training guidelines; (c) the ability to observe and record accurately; (d) a satisfactory knowledge of the language of the flag of the vessel or farm observed. OBLIGATIONS OF THE ICCAT REGIONAL OBSERVER 2. The ICCAT regional observers shall: (a) have completed the technical training required by the guidelines established by ICCAT; (b) be nationals of one of the Member States and, to the extent possible, not of the farm or trap state or the flag State of the purse seiner. If, however, bluefin tuna is harvested from the cage and traded as fresh products, the ICCAT regional observer that observes the harvest may be a national of the Member State responsible for the farm; (c) be capable of performing the tasks set out in point 3; (d) be included in the list of ICCAT regional observers maintained by ICCAT; (e) not have current financial or beneficial interests in the bluefin tuna fishery. ICCAT REGIONAL OBSERVER TASKS 3. The tasks of ICCAT regional observers shall be, in particular: (a) as regards observers on purse seine vessels, to monitor the purse seine vessels' compliance with the relevant conservation and management measures adopted by ICCAT. In particular, the regional observer shall: (1) in cases where the ICCAT regional observer observes what may constitute non-compliance with ICCAT recommendations, he/she shall submit that information without delay to the ICCAT regional observer implementing company who shall forward it without delay to the flag State authorities of the catching vessel; (2) record and report upon the fishing activities carried out; (3) observe and estimate catches and verify entries made in the logbook; (4) issue a daily report of the purse seine vessels' transfer activities; (5) sight and record vessels which may be fishing in contravention of ICCAT conservation and management measures; (6) record and report upon the transfer activities carried out; (7) verify the position of the vessel when engaged in transfer; (8) observe and estimate products transferred, including through the review of video recordings; (9) verify and record the name of the fishing vessel concerned and its ICCAT number; (10) carry out scientific work such as collecting Task II data when required by the ICCAT Commission, based on the directives from the SCRS; (b) as regards ICCAT regional observers in farms and traps, to monitor their compliance with the relevant conservation and management measures adopted by ICCAT. In particular, the ICCAT regional observer shall: (1) verify the data contained in the transfer declaration and caging declaration and BCD, including through the review of video records; (2) certify the data contained in the transfer declaration and caging declaration and BCDs; (3) issue a daily report of the farms' and traps' transfer activities; (4) countersign the transfer declaration and caging declaration and BCDs only when he/she agrees that the information contained within them is consistent with his/her observations including a compliant video record as per the requirements referred to in Article 35(1) and Article 44(1); (5) carry out such scientific work, for example collecting samples, as required by the Commission, based on the directives from the SCRS; (6) register and verify the presence of any type of tag, including natural marks, and notify any sign of recent tag removals; (c) establish general reports compiling the information collected in accordance with this point and provide the master and farm operator with the opportunity to include therein any relevant information; (d) submit to the Secretariat the general report referred to in point (c) within 20 days from the end of the period of observation; (e) exercise any other functions as defined by the ICCAT Commission. 4. The ICCAT regional observer shall treat as confidential all information with respect to the fishing and transfer operations of the purse seiners and of the farms and shall accept that requirement in writing as a condition of appointment as an ICCAT regional observer. 5. The ICCAT regional observer shall comply with requirements established in the laws and regulations of the flag or farm state which exercises jurisdiction over the vessel or farm to which the ICCAT regional observer is assigned. 6. The ICCAT regional observer shall respect the hierarchy and general rules of behaviour which apply to all vessel and farm personnel, provided such rules do not interfere with the duties of the ICCAT regional observer under this programme, and with the obligations of vessel and farm personnel set out in point 7 of this Annex and Article 51(6). OBLIGATIONS OF THE FLAG MEMBER STATES TOWARDS ICCAT REGIONAL OBSERVERS 7. Member States responsible for the purse seiner, farm or trap, shall ensure that ICCAT regional observers are: (a) allowed access to the vessel, farm and trap personnel and to the gear, cages and equipment; (b) allowed access, upon request, to the following equipment, if present on the vessels to which they are assigned, in order to facilitate the carrying out of their duties set out in point 3 of this Annex: (1) satellite navigation equipment, (2) radar display viewing screens when in use, (3) electronic means of communication; (c) provided with accommodation, including lodging, food and adequate sanitary facilities, equal to those of officers; (d) provided with adequate space on the bridge or pilot house for clerical work, as well as space on deck adequate for carrying out observer duties. COSTS ARISING FROM THE ICCAT REGIONAL OBSERVER PROGRAMME 8. All costs arising from the operation of ICCAT regional observers shall be borne by each farm operator or owner of purse seiners. ANNEX VIII ICCAT scheme of joint international inspection ICCAT agreed at its Fourth Regular Meeting (Madrid, November 1975) and at its Annual Meeting in 2008 in Marrakesh that: Pursuant to paragraph 3 of Article IX of the Convention, the ICCAT Commission recommends the establishment of the following arrangements for international control outside the waters under national jurisdiction for the purpose of ensuring the application of the Convention and the measures in force thereunder: I. SERIOUS VIOLATIONS 1. For the purposes of these procedures, a serious violation means the following violations of the provisions of the ICCAT conservation and management measures adopted by the ICCAT Commission: (a) fishing without a licence, permit or authorisation issued by the flag CPC; (b) failure to maintain sufficient records of catch and catch-related data in accordance with the ICCAT Commission's reporting requirements or significant misreporting of such catch and/or catch-related data; (c) fishing in a closed area; (d) fishing during a closed season; (e) intentional taking or retention of species in contravention of any applicable conservation and management measure adopted by ICCAT; (f) significant violation of catch limits or quotas in force pursuant to ICCAT rules; (g) using prohibited fishing gear; (h) falsifying or intentionally concealing the markings, identity or registration of a fishing vessel; (i) concealing, tampering with or disposing of evidence relating to the investigation of a violation; (j) multiple violations which, taken together, constitute a serious disregard of measures in force pursuant to ICCAT; (k) assault, resist, intimidate, sexually harass, interfere with, or unduly obstruct or delay an authorised inspector or observer; (l) intentionally tampering with or disabling the VMS; (m) such other violations as may be determined by the ICCAT, once those are included and circulated in a revised version of those procedures; (n) fishing with the assistance of spotter planes; (o) interference with the satellite monitoring system and/or operation of a vessel without the VMS; (p) transfer activity without transfer declaration; (q) transhipment at sea. 2. In the case of any boarding and inspection of a fishing vessel during which the authorised inspector observes an activity or condition that would constitute a serious violation, as defined in point 1, the authorities of the flag State of the inspection vessels shall immediately notify the flag State of the fishing vessel, directly as well as through the ICCAT Secretariat. In such situations, the inspector shall also inform any inspection ship of the flag State of the fishing vessel known to be in the vicinity. 3. The ICCAT inspector shall register, in the fishing vessel's logbook, the inspections undertaken and any infringements detected. 4. The flag Member State shall ensure that, following the inspection referred to in point 2, the fishing vessel concerned ceases all fishing activities. The flag Member State shall require the fishing vessel to proceed within 72 hours to a port designated by it, where an investigation shall be initiated. 5. If the vessel is not called to port, the flag Member State shall provide due justification in a timely manner to the European Commission which shall forward the information to the ICCAT Secretariat, who shall make it available on request to other Contracting Parties. II. CONDUCT OF INSPECTIONS 6. Inspections shall be carried out by inspectors designated by the Contracting Parties. The names of the authorised government agencies and each inspector designated for that purpose by their respective governments shall be notified to the ICCAT Commission. 7. Ships carrying out international boarding and inspection duties in accordance with this Annex shall fly a special flag or pennant approved by the ICCAT Commission and issued by the ICCAT Secretariat. The names of the ships so used shall be notified to the ICCAT Secretariat as soon as practical in advance of the commencement of inspection activities. The ICCAT Secretariat shall make information regarding designated inspection vessels available to all CPCs, including by posting on its password-protected website. 8. Each inspector shall carry an appropriate identity document issued by the authorities of the flag State, which shall be in the form shown in point 21 of this Annex. 9. Subject to the arrangements agreed under point 16, a vessel flagged to a Contracting Party and fishing for tuna or tuna-like fish in the Convention area outside the waters within its national jurisdiction shall stop when given the appropriate signal in the International Code of Signals by a ship flying the ICCAT pennant described in point 7 and carrying an inspector, unless the vessel is actually carrying out fishing operations, in which case it shall stop immediately once it has finished such operations. The master of the vessel shall permit the inspection party, as specified in point 10, to board it and shall provide a boarding ladder. The master shall enable the inspection party to make such examination of equipment, catch or gear and any relevant documents as an inspector deems necessary to verify the compliance with the ICCAT Commission's recommendations in force in relation to the flag State of the vessel being inspected. Further, an inspector may ask for any explanations that are deemed necessary. 10. The size of the inspection party shall be determined by the commanding officer of the inspection vessel, taking into account relevant circumstances. The inspection party shall be as small as possible to safely and securely accomplish the duties set out in this Annex. 11. Upon boarding the vessel, the inspector shall produce the identity documentation described in point 8. The inspector shall observe generally accepted international regulations, procedures and practices relating to the safety of the vessel being inspected and its crew, and shall minimise interference with fishing activities or stowage of product and, to the extent practicable, avoid action which would adversely affect the quality of the catch on board. Each inspector shall limit his/her enquiries to the ascertainment of the observance of the ICCAT Commission's recommendations in force in relation to the flag State of the vessel concerned. In making the inspection, an inspector may ask the master of the fishing vessel for any assistance that may be required. The inspector shall draw up a report of the inspection in a form approved by the ICCAT Commission. The inspector shall sign the report in the presence of the master of the vessel who shall be entitled to add or have added to the report any observations which he/she may think suitable and shall sign such observations. 12. Copies of the report shall be given to the master of the vessel and to the government of the inspection party, which shall transmit copies to the appropriate authorities of the flag State of the inspected vessel and to the ICCAT Commission. Where any infringement of ICCAT recommendations is discovered, the inspector shall, where possible, also inform any inspection ship of the flag State of the fishing vessel known to be in the vicinity. 13. Resistance to an inspector or failure to comply with his/her directions shall be treated by the flag State of the inspected vessel in a manner similar to such conduct committed with respect to a national inspector. 14. The inspector shall carry out his/her duties under these arrangements in accordance with the rules set out in this Regulation, but they shall remain under the operational control of their national authorities and shall be responsible to them. 15. Contracting Parties shall consider and act on inspection reports, sighting information sheets as per Recommendation 94-09 and statements resulting from documentary inspections of foreign inspectors under these arrangements on a similar basis in accordance with their national legislation to the reports of national inspectors. The provisions of this point shall not impose any obligation on a Contracting Party to give the report of a foreign inspector a higher evidential value than it would possess in the inspector's own country. Contracting Parties shall collaborate in order to facilitate judicial or other proceedings arising from a report of an inspector under these arrangements. 16. (a) Contracting Parties shall inform the ICCAT Commission by 15 February each year of their provisional plans for conducting inspection activities under this Regulation in that calendar year and the ICCAT Commission may make suggestions to Contracting Parties for the coordination of national operations in this field, including the number of inspectors and ships carrying inspectors. (b) The arrangements set out in this Regulation and the plans for participation shall apply between Contracting Parties unless otherwise agreed between them, and such agreement shall be notified to the ICCAT Commission. However, the implementation of the scheme shall be suspended between any two Contracting Parties if either of them has notified the ICCAT Commission to that effect, pending completion of such an agreement. 17. (a) The fishing gear shall be inspected in accordance with the regulations in force for the subarea in which the inspection takes place. The inspector shall state the subarea for which the inspection took place, and a description of any violations found in the inspection report. (b) The inspector shall be entitled to inspect all fishing gear in use or on board. 18. The inspector shall affix an identification mark approved by the ICCAT Commission to any fishing gear inspected which appears to be in contravention of the ICCAT Commission recommendations in force in relation to the flag State of the vessel concerned and shall record this fact in the inspection report. 19. The inspector may photograph the gear, equipment, documentation and any other element he/she consider necessary in such a way as to reveal those features which in his/her opinion are not in conformity with the regulation in force, in which case the subjects photographed shall be listed in the report and copies of the photographs shall be attached to the copy of the report to the flag State. 20. The inspector shall, as necessary, inspect all catch on board to determine compliance with ICCAT recommendations. 21. The model identity card for inspectors is as follows: ANNEX IX Minimum standards for video recording procedures Transfer operations 1. The electronic storage device containing the original video record shall be provided to the ICCAT regional observer as soon as possible after the end of the transfer operation, who shall immediately initialise it to avoid any further manipulation. 2. The original recording shall be kept on board the catching vessel or by the farm or trap operator, where appropriate, during its entire period of authorisation. 3. Two identical copies of the video record shall be produced. One copy shall be transmitted to the ICCAT regional observer on board the purse seiner and one to the national observer on board the towing vessel, the latter of which shall accompany the transfer declaration and the associated catches to which it relates. That procedure shall only apply to national observers in the case of transfers between towing vessels. 4. At the beginning and/or the end of each video, the ICCAT transfer authorisation number shall be displayed. 5. The time and the date of the video shall be continuously displayed throughout each video record. 6. Before the start of the transfer, the video shall include the opening and closing of the net/door and footage showing whether the receiving and donor cages already contain bluefin tuna. 7. The video recording shall be continuous without any interruptions and cuts and cover the entire transfer operation. 8. The video record shall be of sufficient quality to estimate the number of bluefin tuna being transferred. 9. If the video record is of insufficient quality to estimate the number of bluefin tuna being transferred, then a new transfer shall be requested by the control authorities. The new transfer shall include all the bluefin tuna in the receiving cage into another cage which must be empty. Caging operations 1. The electronic storage device containing the original video record shall be provided to the ICCAT regional observer as soon as possible after the end of the caging operation, who shall immediately initialise it to avoid any further manipulation. 2. The original recording shall be kept by the farm, where applicable, during their entire period of authorisation. 3. Two identical copies of the video record shall be produced. One copy shall be transmitted to the ICCAT regional observer deployed on the farm. 4. At the beginning and/or the end of each video, the ICCAT caging authorisation number shall be displayed. 5. The time and the date of the video shall be continuously displayed throughout each video record. 6. Before the start of the caging, the video shall include the opening and closing of the net/door and whether the receiving and donor cages already contain bluefin tuna. 7. The video recording shall be continuous without any interruptions and cuts and cover the entire caging operation. 8. The video record shall be of sufficient quality to estimate the number of bluefin tuna being transferred. 9. If the video record is of insufficient quality to estimate the number of bluefin tuna being transferred, then a new caging operation shall be requested by the control authorities. The new caging operation shall include all the bluefin tuna in the receiving farm cage into another farm cage which shall be empty. ANNEX X Standards and procedures for the programmes and reporting obligations referred to in Article 46(2) to (7) and Article 47(1) A. Use of stereoscopical cameras systems The use of stereoscopic cameras systems in the context of caging operations, as required by Article 46 of this Regulation, shall be conducted in accordance with the following: 1. The sampling intensity of live fish shall not be below 20 % of the amount of fish being caged. When technically possible, the sampling of live fish shall be sequential, one in every five specimens being measured; such a sample shall be made up of fish measured at a distance between 2 and 8 metres from the camera. 2. The dimensions of the transfer gate connecting the donor cage and the receiving cage shall be set at a maximum width of 10 metres and a maximum height of 10 metres. 3. When the length measurements of the fish present a multi-modal distribution (two or more cohorts of distinct sizes), it shall be possible to use more than one conversion algorithm for the same caging operation; the most up-to-date algorithm(s) established by SCRS shall be used to convert fork lengths into total weights, according to the size category of the fish measured during the caging operation. 4. Validation of the stereoscopical length measurements shall be undertaken prior to each caging operation using a scale bar at a distance of between 2 and 8 metres. 5. When the results of the stereoscopical programme are communicated, the information shall indicate the margin of error inherent to the technical specifications of the stereoscopic camera system, which shall not exceed a range of +/– 5 %. 6. The report on the results of the stereoscopical programme shall include details on all the technical specifications above, including the sampling intensity, the way of sampling methodology, the distance from the camera, the dimensions of the transfer gate, and the algorithms (length-weight relationship). SCRS shall review those specifications and, if necessary, provide recommendations to modify them. 7. In cases where the stereoscopic camera footage is of insufficient quality to estimate the weight of bluefin tuna being caged, a new caging operation shall be ordered by the Member State authorities responsible for the catching vessel, trap or farm. B. Presentation and use of the results of the programmes 1. Decisions regarding differences between the catch report and the results from the stereoscopical system programme shall be taken at the level of the JFO or total trap catches, for JFOs and trap catches destined to a farm facility involving a single CPC and/or Member State. The decision regarding differences between the catch report and the results from the stereoscopical system programme shall be taken at the level of the caging operations for JFOs involving more than one CPC and/or Member State, unless otherwise agreed by all the flag CPC and/or Member State authorities of the catching vessels involved in the JFO. 2. The Member State responsible for the farm shall provide a report to the Member State or CPC responsible for the catching vessel or trap and to the Commission, including the following documents: (a) technical stereoscopical system report including: — general information: species, site, cage, date, algorithm, — sizing statistical information: average weight and length, minimum weight and length, maximum weight and length, number of fish sampled, weight distribution, size distribution; (b) detailed results of the programme, with the size and weight of every fish that was sampled; (c) caging report including: — general information on the operation: number of the caging operation, name of the farm, cage number, BCD number, ITD number, name and flag of the catching vessel or trap, name and flag of the towing vessel, date of the stereoscopical system operation and footage file name, — algorithm used to convert length into weight, — comparison between the amounts declared in the BCD and the amounts found with the stereoscopical system, in number of fish, average weight and total weight (the formula used to calculate the difference shall be: (stereoscopical system-BCD)/stereoscopical system * 100), — margin of error of the system, — for those caging reports relating to JFOs/traps, the last caging report shall also include a summary of all information in previous caging reports. 3. When receiving the caging report, the Member State authorities of the catching vessel or trap shall take all the necessary measures according to the following situations: (a) the total weight declared by the catching vessel or trap in the BCD is within the range of the stereoscopical system results: — no release shall be ordered, — the BCD shall be modified both in number (using the number of fish resulting from the use of the control cameras or alternative techniques) and average weight, while the total weight shall not be modified; (b) the total weight declared by the catching vessel or trap in the BCD is below the lowest figure of the range of the stereoscopical system results: — a release shall be ordered using the lowest figure in the range of the stereoscopical system results, — the release operations shall be carried out in accordance with the procedure laid down in Article 34(2) and Annex XI, — after the release operations took place, the BCD shall be modified both in number (using the number of fish resulting from the use of the control cameras, minus the number of fish released) and average weight, while the total weight shall not be modified; (c) the total weight declared by the catching vessel or trap in the BCD exceeds the highest figure of the range of the stereoscopical system results: — no release shall be ordered, — the BCD shall be modified for the total weight (using the highest figure in the range of the stereoscopical system results), for the number of fish (using the results from the control cameras) and average weight accordingly. 4. For any relevant modification of the BCD, the values (number and weight) entered in Section 2 shall be consistent with those in Section 6 and the values in Sections 3, 4 and 6, shall be not higher those in Section 2. 5. In case of compensation of differences found in individual caging reports across all cagings from a JFO/trap, whether or not a release operation is required, all relevant BCDs shall be modified on the basis of the lowest range of the stereoscopical system results. The BCDs related to the quantities of bluefin tuna released shall also be modified to reflect the weight/number released. The BCDs related to bluefin tuna not released but for which the results from the stereoscopical systems or alternative techniques differ from those reported caught and transferred shall also be amended to reflect those differences. The BCDs relating to the catches from where the release operation took place shall also be modified to reflect the weight/number released. ANNEX XI Release protocol 1. The release of bluefin tuna from farming cages into the sea shall be recorded by video camera and observed by an ICCAT regional observer, who shall draft and submit a report together with the video records to the ICCAT Secretariat. 2. When a release order has been issued, the farm operator shall request the deployment of an ICCAT regional observer. 3. The release of bluefin tuna from transport cages or traps into the sea shall be observed by a national observer of the Member State responsible for the towing vessel or trap, who shall draft and submit a report to the responsible Member State control authorities. 4. Before a release operation takes place, Member State control authorities might order a control transfer using standard and/or stereoscopic cameras to estimate the number and weight of the fish that need to be released. 5. Member State authorities may implement any additional measures they consider necessary to guarantee that the release operations take place at the most appropriate time and place in order to increase the probability of the fish going back to the stock. The operator shall be responsible for the fish survival until the release operation has taken place. Those release operations shall take place within three weeks of the completion of the caging operations. 6. Following completion of harvesting operations, fish remaining in a farm and not covered by the BCD shall be released in accordance with the procedures laid down in Article 34(2) and this Annex. ANNEX XII Treatment of dead fish During fishing operations by purse seiners, the quantities of fish found dead in the seine shall be recorded in the fishing vessel logbook and shall be deducted from the Member State quota accordingly. Recording/treating of dead fish during the first transfer (1) The BCD shall be provided to the operator of the towing vessel with Section 2 (Total catch), Section 3 (Live fish trade) and Section 4 (Transfer — including ‘dead’ fish) completed. The total quantities reported in Sections 3 and 4 shall be equal to the quantities reported in Section 2. The BCD shall be accompanied by the original ICCAT Transfer Declaration (ITD) in accordance with the provisions of this Regulation. The quantities reported in the ITD (transferred live), shall be equal to the quantities reported in Section 3 in the associated BCD. (2) A split of the BCD with Section 8 (Trade information) shall be completed and given to the operator of the auxiliary vessel which transports the dead bluefin tuna to shore (or retained on the catching vessel if landed directly to shore). The dead fish and split BCD shall be accompanied by a copy of the ITD. (3) The quantities of dead fish shall be recorded in the BCD of the catching vessel which made the catch or, in the case of JFOs, in the BCD of the catching vessels or of a vessel flying another flag participating in the JFO. ANNEX XIII Correlation table Regulation (EC) No 302/2009 This Regulation Article 1 Articles 1 and 2 Article 2 Article 3 Article 3 Article 4 Article 4(1) Article 5(1) Article 4(2) Article 6(1)(a) Article 4(3) and (5) Article 7 Article 4(4), second subparagraph Article 6(1)(a) and (2) Article 4(6)(a),(b) and second subparagraph Article 54 Article 4(6), third subparagraph Article 20(2) Article 4(7) to (12) — Article 4(13) Article 5(3) Article 4(15) Article 17 Article 5(1) Article 6(1)(b) Article 5(2) to (6) Article 9(1) to (6) Article 5(7),(8) and the first subparagraph of paragraph 9 — Article 5(9), second subparagraph Article 6(2) Article 6 Article 10 Article 7 Articles 11 and 12 Article 8 Article 17 Article 9(1) and (2) Article 14(1) and (2) Article 9(3),(4),(5) and (7) to (10) Annex I Article 9(6) — Article 9(11) Article 14(3) Article 9(12) to (15) Article 15 Article 10 — Article 11 Article 16(2),(3) and (5) Article 12(1) to (4) Article 19 Article 12(5) — Article 13(1),(2) and (3) Article 19 Article 13(4) — Article 14(1),(2),(3) and (5) Article 20 Article 14(4) Article 22(1) Article 15 Article 23 Article 16 Article 29(1),(3) and (4) Article 17 Article 30 Article 18(1) Article 25 Article 18(2) Annex II Article 19 Article 24(1),(2) and (3) Article 20(1) and (2) Article 26(1),(2) and (3) Article 20(3) and (4) Article 27 Article 21 Article 31(1) to (4) and (6) Article 22(1) and the first subparagraph of paragraph 2 Article 33(1),(3) and (5) Article 22(2), second subparagraph Article 34(1) Article 22(3) Article 34(2) Article 22(4) Article 38(1),(2) and (3) Article 22(5) Annex II Article 22(6) Article 33(6) Article 22(7) Article 35(1) and Annex IX Article 22(8) and the first subparagraph of paragraph 9 Article 36 Article 22(9), second subparagraph — Article 22(10) Article 39 Article 23 Article 32 Article 24(1) Article 47(1) Article 24(2),(4) and (6) Article 40(2) to (5) Article 24(3) Article 41(1) and (2) Article 24(5) Article 42 Article 24(7) Article 44(1) and Annex IX Article 24(8), first subparagraph Article 45(1) and (2) Article 24(9) — Article 24(10) Article 48 Article 24a Annex X Article 25 Article 49 Article 26(1) Article 26(4) Article 26(2) Article 27(1) Article 26(3) Article 26(5) Article 27(1) Article 31(5) Article 27(2) Article 41 Article 27(3) Article 3 point (24) Article 28 Article 55 Article 29 Article 52 Article 30 Article 50 Article 31(1) and (2)(a),(b),(c) and (h) Article 51 (2) to (6) Article 31(2)(d) to (g) Annex VII Article 31(3) and (4) Annex VII Article 32 Article 35(2),(3) and (4) Article 44(2),(3) and (4) Article 33 — Article 33a Article 53 Article 34 Article 56 Article 35 — Article 36 — Article 37 Article 57 Article 38 Article 58 Article 38a Article 59(1) and (2) Article 39 Article 60 Article 40 — Article 41 Article 61

Multiannual recovery plan for bluefin tuna Multiannual recovery plan for bluefin tuna SUMMARY OF: Regulation (EU) 2016/1627 on a multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean WHAT IS THE AIM OF THE REGULATION? It updates the rules of the European Union (EU) on applying the multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean, which runs from 2007 to 2022, and is recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT), an intergovernmental fishery organisation to which the EU is a contracting party. It replaces and repeals Regulation (EC) No 302/2009. KEY POINTS The regulation’s objective is to achieve a biomass* of bluefin tuna corresponding to the maximum sustainable yield by 2022 with at least a 60% probability of achieving that objective. Each EU Member State must: ensure that the fishing effort of its catching vessels and its traps are proportionate to the bluefin tuna fishing opportunities (total allowable catches allocated under Regulation (EU) No 1380/2013 — the EU’s common fisheries policy) available to it in the eastern Atlantic and the Mediterranean; submit to the European Commission an annual fishing plan for its vessels and traps and annual fishing capacity and farming management plans that ensure its fishing capacity is in line with its allocated quota. The regulation contains rules on: minimum conservation reference sizes (generally, 30 kg or 115 cm fork length, although lower in certain fisheries); incidental catches (parts of catches which are not targeted) — up to maximum of 5% of bluefin tuna weighing between 8 and 30 kg or with a fork length between 75 and 115 cm; the use of (prohibited) aerial means, such as aircraft, to search for bluefin tuna; records of both fishing and non-catching vessels and traps — Member States have to supply these to the Commission each year; recording requirements — vessels must use logbooks to record information (Annex II, Part A); designated ports for landing or transhipping bluefin tuna — Member States must send a list of these ports to the Commission each year; caging operations, their authorisation and inspection; monitoring and surveillance — vessel monitoring, national observer programmes and the ICCAT regional observer programme; inspections and cross-checks — the ICCAT joint scheme of international inspection and Member States’ inspection plans; marketing — trade, landing, import, export, pacing in cages for fattening or farming, re-export and transhipment of bluefin tuna are not permitted in the EU unless accompanied by accurate, complete and validated documentation, as set out in this regulation, Regulation (EU) No 640/2010 and Regulation (EC) No 1936/2001 (see summary); catches in the cases of sport or recreational fishing: no more than one bluefin tuna may be caught per vessel,any bluefin tuna landed must be whole, gilled and/or gutted,there are measures to be introduced in Member States to ensure the release of bluefin tuna, especially juveniles, caught alive in the course of sport and recreational fishing,the sale of bluefin tuna caught during sport and recreational fishing is banned. Amending Regulation (EU) 2019/833 Regulation (EU) 2019/833 amends Regulation (EU) 2016/1627, requiring Member States: to draw up an annual fishing capacity management plan to adjust the number of fishing vessels, in order to demonstrate that the fishing capacity is commensurate with the fishing opportunities allocated to the vessels in the relevant time period; with a bluefin tuna quota, to transmit to the Commission by 31 January each year an annual farming management plan which the Commission then compiles and integrates into the EU plan which must be forwarded to the ICCAT Secretariat by 15 February of each year for discussion and approval by ICCAT; in their annual farming management plan, to demonstrate that the total input capacity and the total farming capacity are commensurate with the estimated amount of bluefin tuna available for farming; to make provisions for by-catch of bluefin tuna within their quota and to inform the Commission thereof when transmitting their annual fishing plans. The amending regulation also sets new rules for fishing seasons for different types of vessels and on the level of by-catches of bluefin tuna (which must not exceed 20% of the total catches on board at the end of each fishing trip). The methodology used to calculate those by-catches, in relation to the total catch on board, must be clearly defined in Member States’ annual fishing plans. FROM WHEN DOES THE REGULATION APPLY? It has applied since 6 October 2016. BACKGROUND For further information, see: Bluefin tuna: Council agrees on update of the multiannual recovery plan (Council of the European Union). KEY TERMS Biomass. The mass of tuna in a given body of water at a given time. MAIN DOCUMENT Regulation (EU) 2016/1627 of the European Parliament and of the Council of 14 September 2016 on a multiannual recovery plan for bluefin tuna in the eastern Atlantic and the Mediterranean, and repealing Council Regulation (EC) No 302/2009 (OJ L 252, 16.9.2016, pp. 1–52). Successive amendments to Regulation (EU) 2016/1627 have been incorporated in the original text. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, pp. 22–61). See consolidated version. Regulation (EU) No 640/2010 of the European Parliament and of the Council of 7 July 2010 establishing a catch documentation programme for bluefin tuna Thunnus thynnus and amending Council Regulation (EC) No 1984/2003 (OJ L 194, 24.7.2010, pp. 1–22). Council Regulation (EC) No 1936/2001 of 27 September 2001 laying down control measures applicable to fishing for certain stocks of highly migratory fish (OJ L 263, 3.10.2001, pp. 1–8). See consolidated version. last update 29.10.2021

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11.5.2021 EN Official Journal of the European Union L 166/1 REGULATION (EU) 2021/694 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 172 and Article 173(3) thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Having regard to the opinion of the Committee of the Regions (2), Acting in accordance with the ordinary legislative procedure (3), Whereas: (1) This Regulation lays down a financial envelope for the Digital Europe Programme (the ‘Programme’) for the period 2021-2027, which is to constitute the prime reference amount, within the meaning of point 18 of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources (4), for the European Parliament and for the Council during the annual budgetary procedure. (2) The Programme should be established for a period of seven years to align its duration with that of the multiannual financial framework laid down in Council Regulation (EU, Euratom) 2020/2093 (5) (MFF 2021-2027). (3) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (6) (the ‘Financial Regulation’) applies to the Programme. The Financial Regulation lays down rules on the implementation of the Union budget, including the rules on grants, prizes, procurement, indirect management, financial instruments, budgetary guarantees, financial assistance and the reimbursement of external experts. (4) In accordance with Article 193(2) of the Financial Regulation, a grant may be awarded for an action which has already begun, provided that the applicant can demonstrate the need for starting the action prior to signature of the grant agreement. However, the costs incurred prior to the date of submission of the grant application are not eligible, except in duly justified exceptional cases. In order to avoid any disruption in Union support which could be prejudicial to the interests of the Union, it should be possible to provide in the financing decision, during a limited period of time at the beginning of the MFF 2021-2027, and only in duly justified cases, for the eligibility of activities and underlying costs from the beginning of the 2021 financial year, even if they were implemented and incurred before the grant application was submitted. (5) In accordance with the Financial Regulation, Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (7) and Council Regulations (EC, Euratom) No 2988/95 (8), (Euratom, EC) No 2185/96 (9) and (EU) 2017/1939 (10), the financial interests of the Union are to be protected by means of proportionate measures, including measures relating to the prevention, detection, correction and investigation of irregularities, including fraud, to the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, to the imposition of administrative penalties. In particular, in accordance with Regulations (Euratom, EC) No 2185/96 and (EU, Euratom) No 883/2013, the European Anti-Fraud Office (OLAF) has the power to carry out administrative investigations, including on-the-spot checks and inspections, with a view to establishing whether there has been fraud, corruption or any other illegal activity affecting the financial interests of the Union. The European Public Prosecutor’s Office (EPPO) is empowered, in accordance with Regulation (EU) 2017/1939, to investigate and prosecute criminal offences affecting the financial interests of the Union, as provided for in Directive (EU) 2017/1371 of the European Parliament and of the Council (11). In accordance with the Financial Regulation, any person or entity receiving Union funds is to fully cooperate in the protection of the financial interests of the Union, grant the necessary rights and access to the Commission, OLAF, the Court of Auditors and, in respect of those Member States participating in enhanced cooperation pursuant to Regulation (EU) 2017/1939, the EPPO, and ensure that any third parties involved in the implementation of the Union funds grant equivalent rights. (6) Pursuant to Council Decision 2013/755/EU (12), persons and entities established in overseas countries and territories should be eligible for funding subject to the rules and objectives of the Programme and to possible arrangements applicable to the Member State to which the relevant overseas country or territory is linked. The effectiveness of their participation in the Programme should be monitored and regularly evaluated by the Commission. (7) Pursuant to paragraphs 22 and 23 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (13), the Programme should be evaluated on the basis of information collected in accordance with specific monitoring requirements that correspond to existing needs and comply with Regulation (EU) 2016/679 of the European Parliament and of the Council (14), while avoiding an administrative burden, in particular on Member States, and overregulation, and taking into account existing measuring and benchmarking frameworks in the digital field. Those requirements, where appropriate, should include measurable quantitative and qualitative indicators as a basis for evaluating the effects of the Programme on the ground. (8) The Programme should ensure utmost transparency and accountability of innovative financial instruments and mechanisms that involve the Union budget, with respect to their contribution towards achieving Union objectives, both as regards initial expectations and the end results. (9) The Tallinn Digital Summit of September 2017 and the Conclusions of the European Council of 19 October 2017 indicated the need for the Union to invest in digitising its economies and addressing the skills gap to maintain and enrich European competitiveness and innovation, quality of life and social fabric. The European Council concluded that digital transformation offers immense opportunities for innovation, growth and jobs, will contribute to our global competitiveness, and will enhance creative and cultural diversity. Seizing those opportunities requires collectively tackling some of the challenges posed by the digital transformation and reviewing policies affected by the digital transformation. (10) The European Council concluded in particular that the Union should urgently address emerging trends, including issues such as artificial intelligence (AI) and distributed ledger technologies (e.g. blockchain), while at the same time ensuring a high level of data protection in full compliance with Regulation (EU) 2016/679, digital rights, fundamental rights and ethical standards. The European Council invited the Commission to put forward a European approach to AI by early 2018 and called on the Commission to put forward the necessary initiatives to strengthen the framework conditions with a view to enabling the Union to explore new markets through risk-based radical innovations and to reaffirming the leading role of its industry. (11) Building a strong European digital economy and society would be enhanced by the proper implementation of the Connecting Europe Facility established by a Regulation of the European Parliament and of the Council and the European Electronic Communications Code established by Directive (EU) 2018/1972 of the European Parliament and of the Council (15). (12) In its communication of 14 February 2018, entitled ‘A new, modern Multiannual Financial Framework for a European Union that delivers efficiently on its priorities post-2020’, the Commission, taking into consideration the options for the new multiannual financial framework, outlines a programme for Europe’s digital transformations to deliver strong progress towards smart growth in areas such as high-quality data infrastructure, connectivity and cybersecurity. The Programme would seek to secure European leadership in supercomputing, next generation internet, AI, robotics and big data. It would reinforce the competitive position of industry and business in Europe across the digitised economy and would have a significant impact on bridging and filling the skills gap across the Union so that citizens have the necessary skills and knowledge to face the digital transformation. (13) The Commission communication of 25 April 2018, entitled ‘Towards a common European data space’, addresses the new measures to be taken as a key step towards a common data space in the Union, a seamless digital area with a scale that will enable the development and innovation of new products and services based on data. (14) The general objectives of the Programme should be to support the digital transformation of industry and to foster better exploitation of the industrial potential of policies on innovation, research and technological development, for the benefit of citizens and businesses across the Union, including its outermost regions and its economically disadvantaged regions. The Programme should be structured into five specific objectives that reflect key policy areas, namely: High Performance Computing; Artificial Intelligence; Cybersecurity and Trust; Advanced Digital Skills; and Deployment and Best Use of Digital Capacities and Interoperability. For all those key policy areas, the Programme should also aim to better align Union, Member State and regional policies, and to pool private and industrial resources in order to increase investment and develop stronger synergies. In addition, the Programme should strengthen the Union’s competiveness and the resilience of its economy. (15) The five specific objectives are distinct but interdependent. For example, AI needs cybersecurity to be trustworthy, high performance computing (HPC) capabilities are key for supporting learning in the context of AI, and all three capacities require advanced digital skills. Although individual actions under the Programme relate to a single specific objective, the objectives should not be viewed in isolation, but rather as forming the core of a coherent package. (16) There is a need to support small and medium-sized enterprises (SMEs) that intend to harness the digital transformation in their production processes. Such support would allow SMEs to contribute to the growth of the European economy through an efficient use of resources. (17) A central role in the implementation of the Programme should be attributed to European Digital Innovation Hubs, which should stimulate the broad adoption of advanced digital technologies by industry, in particular by SMEs and by other entities that employ up to 3 000 people (mid-caps), by public organisations and by the academic community. In order to clarify the distinction between digital innovation hubs that comply with the eligibility criteria under the Programme and digital innovation hubs established following the Commission communication of 19 April 2016 entitled ‘Digitising European Industry – Reaping the full benefits of a Digital Single Market’ and financed by other sources, the hubs financed under the Programme should be called European Digital Innovation Hubs. European Digital Innovation Hubs should serve as access points for the latest digital capacities, including HPC, AI, cybersecurity, as well as for other existing innovative technologies such as key enabling technologies, available also in fablabs or citylabs. European Digital Innovation Hubs should act as single-entry points in accessing tested and validated technologies and should promote open innovation. They should also provide support in the area of advanced digital skills, for example by coordinating with education providers for the provision of short-term training for workers and internships for students. The network of European Digital Innovation Hubs should ensure broad geographical coverage across Europe and should contribute to the participation of the outermost regions in the Digital Single Market. (18) During the first year of the Programme, an initial network of European Digital Innovation Hubs should be established through an open and competitive process from among entities designated by Member States. To that end, Member States should be free to propose candidates in accordance with their national procedures and national administrative and institutional structures. The Commission should take the utmost account of the opinion of each Member State before selecting a European Digital Innovation Hub in the territory of that Member State. Entities which already carry out functions as digital innovation hubs in the context of the Digitising European Industry Initiative could be designated by Member States as candidates as a result of an open and competitive process. The Commission should be able to involve independent external experts in the selection process. The Commission and the Member States should avoid the unnecessary duplication of competences and functions at Union and national level. There should therefore be adequate flexibility when designating the hubs and determining their activities and composition. In order to ensure a broad geographical coverage across Europe, as well as a balance of coverage of technologies and sectors, the network might be further enlarged through a subsequent open and competitive process. (19) European Digital Innovation Hubs should develop appropriate synergies with relevant actions funded by Horizon Europe – the Framework Programme for Research and Innovation established by Regulation (EU) 2021/695 of the European Parliament and of the Council (16) (Horizon Europe) or by other research and innovation programmes, with the European Institute of Innovation and Technology (EIT) established by a Regulation of the European Parliament and of the Council, in particular its Knowledge and Innovation Communities (KICs), as well as with established networks such as the Entreprise Europe Network, or the InvestEU Advisory Hub established in accordance with Regulation (EU) 2021/523 of the European Parliament and of the Council (17). (20) European Digital Innovation Hubs should act as facilitators to bring together industries, businesses and public administrations which are in need of new technological solutions, with businesses, in particular start-ups and SMEs, that have market-ready solutions. (21) A consortium of legal entities may be selected as European Digital Innovation Hubs in accordance with point (c) of Article 197(2) of the Financial Regulation that allows entities which do not have legal personality under the applicable national law to participate in calls for proposals, provided that their representatives have the capacity to undertake legal obligations on behalf of those entities and that those entities offer guarantees for the protection of the financial interests of the Union that are equivalent to those offered by legal persons. (22) European Digital Innovation Hubs should be allowed to receive contributions from Member States and participating third countries, including from public authorities within Member States and those third countries, contributions from international bodies or institutions, and contributions from the private sector, in particular from members, shareholders or partners of the European Digital Innovation Hubs. European Digital Innovation Hubs should also be allowed to receive revenues generated by the European Digital Innovation Hubs’ own assets and activities, bequests, donations and contributions from individuals and funding from the Programme and other Union programmes, including in the form of grants. (23) The Programme should be implemented through projects that reinforce and widen the use of essential digital capacities. Such implementation should involve co-financing with Member States and, where necessary, the private sector. The co-financing rate should be established in the work programme. By way of derogation from the general rule, the Union funding should be able to cover up to 100 % of eligible costs. In particular, such financing should require reaching a critical mass in procurement to obtain better value for money and to guarantee that suppliers in Europe stay at the forefront of technology advancements. (24) The policy objectives of the Programme should also be addressed through financial instruments and budgetary guarantees under the InvestEU Programme established by Regulation (EU) 2021/523. (25) The Programme’s actions should be used to improve further the Union’s digital capacities and to address market failures or sub-optimal investment situations, in a proportionate manner, without duplicating or crowding out private financing, and should provide clear European added value. (26) In order to achieve maximum flexibility throughout the lifetime of the Programme and to develop synergies between the components of the Programme, it should be possible for each of the specific objectives to be implemented through any of the instruments available under the Financial Regulation. The delivery mechanisms to be used are direct management and indirect management, where Union financing should be combined with other sources of financing or where execution requires the setup of commonly governed structures. Moreover, in order to respond in particular to new developments and needs such as new technologies, the Commission is allowed to propose to deviate from the indicative amounts set out in this Regulation in the context of the annual budgetary procedure and in accordance with the Financial Regulation. (27) In order to ensure the efficient allocation of funds from the Union budget, it is necessary to ensure the European added value of all actions and activities carried out under the Programme and their complementarity with Member States’ activities, while consistency, complementarity and synergies should be sought with funding programmes that support policy areas that are closely linked to each other. Although the relevant work programmes provide a tool for ensuring consistency for directly and indirectly managed actions, collaboration between the Commission and the relevant Member States authorities should be established to ensure consistency and complementarities between directly or indirectly managed funds and funds that are subject to shared management, while complying with the applicable provisions of a Regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (the ‘Common Provisions Regulation for 2021-2027’). (28) The HPC capacities and the related data processing in the Union should ensure the wider use of HPC by industry and, more generally, in areas of public interest, in order to seize unique opportunities that supercomputers bring to society as regards health, environment and security, as well as to the competitiveness of industry, in particular SMEs. Acquiring world-class supercomputers would secure the Union’s supply system and would help deploy services for simulation, visualisation and prototyping, while ensuring that HPC systems comply with Union values and principles. (29) The support for the Union’s intervention in the HPC area was expressed by the European Parliament and by the Council. Moreover, between 2017 and 2018, 22 Member States signed the European Declaration on HPC, a multi-government agreement in which they committed to collaborating with the Commission to build and deploy state-of-the-art HPC infrastructures and data infrastructures in Europe that would be available to scientific communities and to public and private partners across the Union. (30) As highlighted in the impact assessment accompanying the Commission proposal for a Council Regulation establishing the European High Performance Computing Joint Undertaking, in order to achieve Specific Objective ‘High Performance Computing’, a joint undertaking is deemed to be the most suitable means of implementation, in particular to coordinate Union and national strategies and investments in HPC infrastructure, as well as research and development, pool resources from public and private funds, and safeguard the economic and strategic interests of the Union. Moreover, the national High Performance Computing competence centres within the meaning of the Council Regulation (EU) 2018/1488 (18) provide HPC services to industry, including SMEs and start-ups, the academic community and public administrations. (31) Developing capacity related to AI is a crucial driver for the digital transformation of industry, services and the public sector. Ever more autonomous robots are used in factories, deep sea applications, homes, cities and hospitals. Commercial AI platforms have moved from testing to having real applications in the health and environmental sectors. All major car manufacturers are developing self-driving cars, and machine-learning techniques are at the heart of all main web platforms and big data applications. It is essential for Europe to join forces at all levels to be competitive internationally. Member States have acknowledged this through concrete commitments for collaboration in a coordinated action plan. (32) Libraries of algorithms may cover a large set of algorithms, including simple solutions such as classification algorithms, neural network algorithms and planning or reasoning algorithms. They may also cover more complex solutions, such as speech recognition algorithms, navigation algorithms embedded in autonomous devices, such as drones or autonomous cars and AI algorithms built into robots to enable them to interact with and adapt to their environment. Libraries of algorithms should be made easily accessible to everyone on the basis of fair, reasonable and non-discriminatory terms. (33) In its resolution of 1 June 2017 on digitising European industry, the European Parliament pointed out the impact of language barriers on industry and on the digitisation of industry. In that context, the development of large-scale AI-based language technologies, such as automatic translation, speech recognition, big data text analytics, dialogue and question-answering systems, is essential to preserving linguistic diversity, ensuring inclusiveness and enabling human-to-human and human-to-machine communication. (34) Products and services based on AI should be user-friendly, should comply with the law by default and should provide consumers with more choice and more information, in particular regarding the quality of products and services. (35) The availability of large-scale data sets and of testing and experimentation facilities are of major importance to the development of AI, including language technologies. (36) In its resolution on digitising European industry, the European Parliament highlighted the importance of a common European cybersecurity approach and recognised the need to raise awareness. It considered cyber-resilience as a crucial responsibility for business leaders and national and European industrial and security policymakers, as well as the implementation of security and privacy by design and by default. (37) Cybersecurity is a challenge for the entire Union that cannot be addressed only by national initiatives. Europe’s cybersecurity capacity should be reinforced to endow Europe with the necessary capacities to protect its citizens, public administrations and businesses from cyber threats. In addition, consumers should be protected when using connected products that can be hacked and can compromise their safety. Such protection should be achieved together with Member States and the private sector by developing projects to reinforce Europe’s capacities in cybersecurity, by ensuring coordination between those projects and by ensuring the wide deployment of the latest cybersecurity solutions across the economy, including dual-use projects, services, competences and applications, as well as by aggregating competences in this field to ensure critical mass and excellence. (38) In September 2017, the Commission put forward a package of initiatives setting out a comprehensive Union approach to cybersecurity, with the aim of reinforcing Europe’s capacity to deal with cyberattacks and cyber threats and to strengthen technology and industrial capacity in this field. That package includes Regulation (EU) 2019/881 of the European Parliament and of the Council (19). (39) Trust is a prerequisite for the Digital Single Market to function. Cybersecurity technologies such as digital identities, cryptography and intrusion detection, and their application in areas such as finance, industry 4.0, energy, transport, healthcare, and e-government are essential to safeguarding the security of, and trust in, online activities and transactions by citizens, public administrations, and businesses. (40) The European Council, in its conclusions of 19 October 2017, stressed that to successfully build a Digital Europe, the Union needs labour markets, training and education systems that are fit for the digital age and that there is a need to invest in digital skills to empower and enable all Europeans. (41) In its conclusions of 14 December 2017, the European Council called on Member States, the Council and the Commission to take forward the agenda of the Gothenburg Social Summit of November 2017, including the European Pillar of Social Rights, as well as education and training and the delivery of the new European Skills Agenda. The European Council also asked the Commission, the Council and the Member States to examine possible measures to address the skills challenges linked to digitisation, cybersecurity, media literacy and AI and to address the need for an inclusive, lifelong-learning-based and innovation-driven approach to education and training. In response, the Commission presented on 17 January 2018 a first package of measures, addressing key competences, digital skills, common values and inclusive education. In May 2018, a second package of measures was launched, advancing work to build a European Education Area by 2025, which also emphasises the centrality of digital skills. Media literacy includes essential competencies (knowledge, skills and attitudes) that allow citizens to engage effectively with media and other information providers and to develop critical thinking and lifelong learning skills for socialising and becoming active citizens. (42) Considering the need for a holistic approach, the Programme should also take into account inclusion, qualification, training and specialisation, which, in addition to advanced digital skills, are decisive for the creation of added value in the knowledge society. (43) In its resolution on digitising European industry, the European Parliament stated that education, training and lifelong learning are the cornerstone of social cohesion in a digital society. It further demanded that the gender balance perspective be incorporated in all digital initiatives, emphasising the need to address the gender gap within the information and communications technology (ICT) sector, since this is essential to Europe’s long-term growth and prosperity. (44) The advanced digital technologies supported by the Programme, such as HPC, cybersecurity and AI, are now sufficiently mature to move beyond the research phase and be deployed, implemented and scaled-up at Union level. In the same way as the deployment of those technologies require a Union response, so does the advanced digital skills dimension. Training opportunities in advanced digital skills, including data protection competencies, need to be scaled up, increased and made accessible throughout the Union. Failing to do that could impede the smooth deployment of advanced digital technologies and could hamper the overall competitiveness of Union’s economy. The actions supported by the Programme are complementary to those supported by the European Social Fund Plus (ESF+), the European Regional Development Fund (ERDF) and Erasmus+, each established by a Regulation of the European Parliament and of the Council, and Horizon Europe. Those actions will target the Union workforce in the private sector as well as the public sector, in particular ICT professionals and other related professionals, as well as students, trainees and trainers. The term ‘workforce’ refers to the economically active population, and includes both workers and self-employed people who are in occupation and unemployed people. (45) Modernising public administrations and services by digital means is crucial to reducing the administrative burden on businesses, including SMEs, and on citizens in general by making their interactions with public authorities faster, more convenient and less costly, as well as by increasing the efficiency, transparency and the quality of the services provided to citizens and businesses, while at the same time increasing the efficiency of public spending. Since a number of services of public interest already have a Union dimension, the support provided to their implementation and deployment at Union level should ensure that citizens and businesses will beable to benefit from access to high-quality digital services across the Union that are, where possible, multilingual. Moreover, Union support in this area is expected to encourage the re-use of public sector information. (46) Digitalisation can facilitate and improve barrier-free accessibility to all, including older people, people with reduced mobility or with disabilities, and people in remote or rural areas. (47) The digital transformation of areas of public interest such as healthcare, mobility, justice, earth or environmental monitoring, security, the reduction of carbon emissions, energy infrastructure, education and training, and culture requires the continuation and expansion of digital service infrastructures, which make possible the secure cross-border exchange of data and which foster national development. Coordination between those digital service infrastructures under this Regulation would best achieve the potential for exploiting synergies. (48) The deployment of the necessary digital technologies, in particular those under Specific Objectives ‘High Performance Computing’, ‘Artificial Intelligence’ and ‘Cybersecurity and Trust’, is key to reaping the benefits of digital transformation and might be complemented by other leading-edge and future technologies, such as distributed ledger technologies (e.g. blockchain). (49) The digital transformation should allow citizens to have access to, use and manage their personal data securely across borders, irrespective of their location or the location of the data. (50) In the Tallinn Declaration on eGovernment of 6 October 2017, the ministers in charge of eGovernment policy and coordination from the Member States and the countries which are members of the European Free Trade Association concluded that digital progress is transforming their societies and economies to the core, challenging the effectiveness of previously developed policies in a broad range of areas as well as the role and function of the public administration overall, and that it is their duty to anticipate and manage those challenges to meet the needs and expectations of citizens and businesses. (51) The modernisation of European public administrations is one of the key priorities for successful implementation of the Digital Single Market. The mid-term evaluation of the Digital Single Market strategy highlighted the need to strengthen the transformation of public administrations and to ensure citizens have easy, trusted, and seamless access to public services. (52) The Annual Growth Survey published by the Commission in 2017 shows that the quality of European public administrations has a direct impact on the economic environment and is therefore crucial to stimulating productivity, competitiveness, economic cooperation, sustainable growth, employment and high-quality jobs. In particular, efficient and transparent public administrations and effective justice systems are necessary to support economic growth and to deliver high-quality services to citizens and businesses. (53) The interoperability of European public services concerns all levels of administration: Union, national, regional and local. Besides removing barriers to a functioning internal market, interoperability facilitates cross-border cooperation, the promotion of European standards and the successful implementation of policies, and offers great potential for avoiding cross-border electronic barriers, further securing the emergence of new, and the consolidation of developing, common public services at Union level. In order to eliminate the fragmentation of European public services and to support fundamental freedoms and operational mutual recognition in the Union, a holistic cross-sector and cross-border approach to interoperability should be promoted in the manner that is most effective and is most responsive to end-users. Such an approach implies that interoperability is to be understood in a broad sense, spanning technical and legal layers and encompassing policy elements in the field. Accordingly, the span of activities would go beyond the usual lifecycle of solutions to include all the intervention elements that would support the necessary framework conditions for sustained interoperability at large. The Programme should also facilitate cross-fertilisation between different national initiatives, leading to the development of a digital society. (54) The Programme should encourage open-source solutions in order to allow reuse, increase trust and secure transparency. Such an approach will have a positive impact on the sustainability of funded projects. (55) The budget allocated to specific actions dedicated to the implementation of the interoperability framework and the interoperability of developed solutions is expected to be EUR 194 million. (56) The European Parliament’s resolution on digitising European industry stressed the importance of unlocking sufficient public and private finance for the digitisation of Europe’s industry. (57) On 19 April 2016, the Commission adopted the Digitising European Industry initiative to ensure that any industry in Europe, big or small, wherever situated and in any sector can fully benefit from digital innovations. This is of particular relevance to SMEs in the cultural and creative sectors. (58) The European Economic and Social Committee welcomed the Commission communication on Digitising European Industry and considered it, together with accompanying documents, as ‘the first step in a vast European work programme to be carried out in close mutual cooperation between all interested public and private parties’. (59) Reaching the target objectives may require leveraging the potential of complementary technologies in the networking and computing domains, as stated in the Commission communication on Digitising European Industry, which recognises the ‘availability of world class networking and cloud infrastructure’ as an essential component of the digitisation of industry. (60) By providing for a single set of rules directly applicable in the Member States legal orders, Regulation (EU) 2016/679 guarantees the free flow of personal data between Member States and reinforces trust and the security of individuals, two indispensable elements for a real Digital Single Market. All actions taken under the Programmewhich involve the processing of personal data should therefore contribute to the smooth implementation of that Regulation, for example in the field of AI and distributed ledger technologies (e.g. blockchain). Those actions should support the development of digital technologies that comply with the obligations on data protection by design and by default. (61) The Programme should be implemented in a manner that fully respects the Union and international framework of intellectual property protection and enforcement. The effective protection of intellectual property plays a key role in innovation and is, therefore, necessary for the effective implementation of the Programme. (62) Third countries which are members of the European Economic Area may participate in Union programmes in the framework of the cooperation established under the Agreement on the European Economic Area (20), which provides for the implementation of the programmes on the basis of a decision adopted under that Agreement. Third countries may also participate on the basis of other legal instruments. Those instruments should be able to provide for partial association, namely association to a limited number of specific objectives pursued under the Programme. A specific provision should be introduced in this Regulation requiring third countries to grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. (63) The bodies entrusted with the implementation of the Programme should comply with the provisions applicable to the Union institutions and with the national law regarding the handling of information, in particular sensitive non-classified information and EU classified information. For Specific Objective ‘Cybersecurity and Trust’, security reasons may require legal entities that are controlled from third countries to be excluded from calls for proposals and tenders under the Programme. In exceptional cases, such exclusions may also be required for Specific Objectives ‘High Performance Computing’ and ‘Artificial Intelligence’. The security reasons for such exclusions should be proportionate and should be duly justified by reference to the risks that the inclusion of such entities would represent. (64) Reflecting the importance of tackling climate change in line with the Union’s commitments to implement the Paris Agreement, adopted under the United Nations Framework Convention on Climate Change (21), and to the United Nations Sustainable Development Goals, the Programme is intended to contribute to the mainstreaming of climate actions and to the achievement of an overall target of 30 % of the Union budget expenditure supporting climate objectives and the ambition of 7,5 % of the budget reflecting biodiversity expenditures in 2024 and 10 % in 2026 and 2027 while considering the existing overlaps between climate and biodiversity goals. Relevant actions should be identified during the Programme’s preparation and implementation, and should be reassessed in the context of the relevant evaluations and review processes. (65) As the Programme is new, it is useful to provide, in an annex, a technical description of the Programme’s scope of actions. That technical description included in such an annex should be taken into account by the Commission when preparing work programmes, whereas the work programmes should be consistent with the specific objectives set out in this Regulation. (66) The work programmes should be adopted in principle as multiannual work programmes, typically every two years, or, if justified by needs related to the implementation of the programme, as annual work programmes. The forms of Union funding and the methods of implementation of the Programme should be chosen on the basis of their ability to achieve the specific objectives of the actions and to deliver results, taking into account, in particular, the costs of controls, the administrative burden, and the expected risk of non-compliance. That choice should include the consideration of the use of lump sums, flat-rate financing and unit costs, as well as financing not linked to costs as referred to in Article 125(1) of the Financial Regulation. (67) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in order to amend Annex I to this Regulation to reflect technological change and market developments, with regard to the actions set out therein in a manner consistent with the objectives of this Regulation and to amend Annex II thereto with regard to the measurable indicators where considered to be necessary as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. (68) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the selection of the entities forming the initial and additional European Digital Innovation Hubs and the adoption of the work programmes for Specific Objectives 2, 4 and 5 and for possible other actions under direct management for Specific Objectives 1 and 3 so that the objectives of the Programme are achieved in accordance with the Union and Member States’ priorities while ensuring consistency, transparency and continuity of joint action by the Union and the Member States. Those implementing powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (22). For actions subject to indirect management, the work programmes are adopted in accordance with rules of the governing boards of the bodies entrusted with the implementation of the Programme. (69) This Regulation respects fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union (the ‘Charter’), in particular those regarding the protection of personal data, the freedom of expression and information, the freedom to conduct business, the prohibition of discrimination, healthcare, consumer protection and the right to effective remedy and fair trial. Member States should apply this Regulation in a manner consistent with those rights and principles. (70) Horizontal financial rules adopted by the European Parliament and the Council on the basis of Article 322 TFEU apply to this Regulation. Those rules are laid down in the Financial Regulation and determine in particular the procedure for establishing and implementing the Union budget through grants, prizes, procurement and indirect management, and provide for checks on the responsibility of financial actors. Rules adopted on the basis of Article 322 TFEU also include a general regime of conditionality for the protection of the Union budget. (71) Since the objectives of this Regulation, namely to support and accelerate the digital transformation of the European economy, industry and society, to bring its benefits to citizens, public administrations and businesses across the Union, and to improve the competitiveness of Europe in the global digital economy while contributing to bridging the digital divide across the Union and reinforcing the Union’s strategic autonomy, cannot be sufficiently achieved by the Member States but can rather, by reason of their scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (72) In order to ensure continuity in providing support in the relevant policy area and to allow implementation to start from the beginning of the MFF 2021-2027, this Regulation should enter into force as a matter of urgency and should apply, with retroactive effect, from 1 January 2021. (73) Decision (EU) 2015/2240 of the European Parliament and of the Council (23) should therefore be repealed, HAVE ADOPTED THIS REGULATION: CHAPTER I GENERAL PROVISIONS Article 1 Subject matter This Regulation establishes the Digital Europe Programme (the ‘Programme’) for the duration of the MFF 2021-2027. This Regulation lays down the objectives of the Programme, its budget for the period 2021 to 2027, the forms of Union funding and the rules for providing such funding. Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘blending operation’ means an action supported by the Union budget, including within a blending facility or platform as defined in point (6) of Article 2 of the Financial Regulation, that combines non-repayable forms of support or financial instruments from the Union budget with repayable forms of support from development or other public finance institutions, as well as from commercial finance institutions and investors; (2) ‘legal entity’ means a natural person, or a legal person created and recognised as such under Union, national, or international law, which has legal personality and the capacity to act in its own name, exercise rights and be subject to obligations, or an entity which does not have legal personality as referred to in point (c) of Article 197(2) of the Financial Regulation; (3) ‘associated country’ means a third country which is party to an agreement with the Union allowing for its participation in the Programme pursuant to Article 10; (4) ‘international organisation of European interest’ means an international organisation, the majority of whose members are Member States or whose headquarters are in a Member State; (5) ‘European Digital Innovation Hub’ means a legal entity selected in accordance with Article 16 in order to fulfil the tasks under the Programme, in particular by directly providing, or ensuring access to, technological expertise and experimentation facilities, such as equipment and software tools to enable the digital transformation of industry, as well as by facilitating access to finance and it is open to businesses of all forms and sizes, in particular to SMEs, mid-caps and scale-up companies, and to public administrations across the Union; (6) ‘advanced digital skills’ means the skills and professional competencies requiring the knowledge and experience necessary to understand, design, develop, manage, test, deploy, use and maintain the technologies, products and services supported by the Programme as referred to in Article 7; (7) ‘European Partnership’ means a European Partnership as defined in point (3) of Article 2 of Regulation (EU) 2021/695; (8) ‘small or medium-sized enterprise’ or ‘SME’ means a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC (24); (9) ‘cybersecurity’ means the activities necessary to protect network and information systems, the users of such systems, and other persons affected by cyber threats; (10) ‘digital service infrastructures’ means infrastructures which enable networked services to be delivered electronically, typically over the internet; (11) ‘Seal of Excellence’ means a quality label which shows that a proposal submitted to a call for proposals under the Programme has passed all of the evaluation thresholds set out in the work programme, but could not be funded due to a lack of budget available for that call for proposals in the work programme, and might receive support from other Union or national sources of funding; (12) ‘exascale’ means, in the context of computing systems, being capable of executing 1018 (ten to the power of 18) floating operations per second. Article 3 Programme objectives 1. The general objectives of the Programme shall be to support and accelerate the digital transformation of the European economy, industry and society, to bring its benefits to citizens, public administrations and businesses across the Union, and to improve the competitiveness of Europe in the global digital economy while contributing to bridging the digital divide across the Union and reinforcing the Union’s strategic autonomy, through holistic, cross-sectoral and cross-border support and a stronger Union contribution. The Programme shall be implemented in close coordination with other Union programmes as applicable, and shall aim: (a) to strengthen and promote Europe’s capacities in key digital technology areas through large-scale deployment; (b) in the private sector and in areas of public interest, to widen the diffusion and uptake of Europe’s key digital technologies, promoting the digital transformation and access to digital technologies. 2. The Programme shall have five interrelated specific objectives: (a) Specific Objective 1 – High Performance Computing (b) Specific Objective 2 – Artificial Intelligence (c) Specific Objective 3 – Cybersecurity and Trust (d) Specific Objective 4 – Advanced Digital Skills (e) Specific Objective 5 Deployment and Best Use of Digital Capacity and Interoperability. Article 4 Specific Objective 1- High Performance Computing 1. The financial contribution from the Union under Specific Objective 1 – High Performance Computing shall pursue the following operational objectives: (a) deploy, coordinate at Union level and operate an integrated demand-oriented and application-driven world-class exascale supercomputing and data infrastructure that shall be easily accessible to public and private users, in particular SMEs, irrespective of the Member State in which they are located, and easily accessible for research purposes, in accordance with Regulation (EU) 2018/1488; (b) deploy ready to use operational technology resulting from research and innovation in order to build an integrated Union HPC ecosystem, covering various aspects in the scientific and industrial value chain segments, including hardware, software, applications, services, interconnections and digital skills, with a high level of security and data protection; (c) deploy and operate post-exascale infrastructure, including integration with quantum computing technologies and research infrastructures for computing science and encourage the development within the Union of the hardware and software necessary for such deployment. 2. The actions under Specific Objective 1 shall be primarily implemented through the European High Performance Computing Joint Undertaking established by Regulation (EU) 2018/1488. Article 5 Specific Objective 2 – Artificial Intelligence 1. The financial contribution from the Union under Specific Objective 2 – Artificial Intelligence shall pursue the following operational objectives: (a) build up and strengthen core AI capacities and knowledge in the Union, including building up and strengthening quality data resources and corresponding exchange mechanisms, and libraries of algorithms, while guaranteeing a human-centric and inclusive approach that respects Union values; (b) make the capacities referred to in point (a) accessible to businesses, especially SMEs and start-ups, as well as civil society, not-for-profit organisations, research institutions, universities and public administrations, in order to maximise their benefit to the European society and economy; (c) reinforce and network AI testing and experimentation facilities in Member States; (d) develop and reinforce commercial application and production systems in order to facilitate the integration of technologies in value chains and the development of innovative business models and to shorten the time required to pass from innovation to commercial exploitation and foster the uptake of AI-based solutions in areas of public interest and in society. AI-based solutions and data made available shall respect the principle of privacy and security by design and shall fully comply with data protection legislation. 2. The Commission, in accordance with Union and international law, including the Charter, and taking into account, inter alia, the recommendations of the High-Level Expert Group on Artificial Intelligence, shall set out ethical requirements in the work programmes under Specific Objective 2. Calls for proposals, calls for tenders and grant agreements shall include the relevant requirements set out in those work programmes. Where appropriate, the Commission shall carry out checks to ensure compliance with those ethical requirements. Funding for actions which do not comply with the ethical requirements may be suspended, terminated or reduced at any time in accordance with the Financial Regulation. 3. The actions under Specific Objective 2 shall be implemented primarily through direct management. The ethical and legal requirements referred to in this Article shall apply to all actions of Specific Objective 2, regardless of the method of implementation. Article 6 Specific Objective 3 – Cybersecurity and Trust 1. The financial contribution from the Union under Specific Objective 3 – Cybersecurity and Trust shall pursue the following operational objectives: (a) support the building-up and procurement of advanced cybersecurity equipment, tools and data infrastructures, together with Member States, in order to achieve a high common level of cybersecurity at European level, in full compliance with data protection legislation and fundamental rights, while ensuring the strategic autonomy of the Union; (b) support the building-up and best use of European knowledge, capacity and skills related to cybersecurity and the sharing and mainstreaming of best practices; (c) ensure a wide deployment of effective state-of-the-art cybersecurity solutions across the European economy, paying special attention to public authorities and SMEs; (d) reinforce capabilities within Member States and private sector to help them comply with Directive (EU) 2016/1148 of the European Parliament and of the Council (25) including through measures supporting the uptake of cybersecurity best practices; (e) improve resilience against cyberattacks, contribute towards increasing risk-awareness and knowledge of cybersecurity processes, support public and private organisations in achieving basics levels of cybersecurity, for example by deploying end-to-end encryption of data and software updates; (f) enhance cooperation between the civil and defence spheres with regard to dual-use projects, services, competences and applications in cybersecurity, in accordance with a Regulation establishing the European Cybersecurity Industrial, Technology and Research Competence Centre and the Network of National Coordination Centres (the ‘Cybersecurity Competence Centre Regulation’). 2. The actions under Specific Objective 3 shall be implemented primarily through the European Cybersecurity Industrial, Technology and Research Competence Centre and the Network of National Coordination Centres in accordance with the Cybersecurity Competence Centre Regulation. Article 7 Specific Objective 4 – Advanced Digital Skills 1. The financial contribution from the Union under Specific Objective 4 – Advanced Digital Skills shall support the development of advanced digital skills in areas covered by the Programme in order to contribute to increasing Europe’s talent pool, bridge the digital divide and foster greater professionalism, especially with regard to high performance and cloud computing, big data analytics, cybersecurity, distributed ledger technologies (e.g. blockchain), quantum technologies, robotics, AI, while taking gender balance into account. In order to tackle skills mismatches and to encourage specialisation in digital technologies and applications, the financial contribution shall pursue the following operational objectives: (a) support the design and delivery of high-quality, long-term training and courses, including blended learning, for students and for the workforce; (b) support the design and delivery of high-quality, short-term training and courses for the workforce, in particular in SMEs and in the public sector; (c) support high-quality on-the-job training and work placements for students, including traineeships, and the workforce, in particular in SMEs and in the public sector. 2. The actions under Specific Objective 4 shall be implemented primarily through direct management. Article 8 Specific Objective 5 – Deployment and Best Use of Digital Capacities and Interoperability 1. The financial contribution from the Union under Specific Objective 5 – Deployment and Best Use of Digital Capacities and Interoperability shall pursue the following operational objectives while bridging the digital divide: (a) support the public sector and areas of public interest, such as health and care, education, judiciary, customs, transport, mobility, energy, environment, cultural and creative sectors, including relevant businesses established within the Union, to effectively deploy and access state-of-the-art digital technologies, such as HPC, AI and cybersecurity; (b) deploy, operate and maintain trans-European interoperable state-of-the-art digital service infrastructures across the Union, including related services, in complementarity with national and regional actions; (c) support the integration and use of trans-European digital service infrastructures and of agreed European digital standards in the public sector and in areas of public interest to facilitate cost-efficient implementation and interoperability; (d) facilitate the development, update and use of solutions and frameworks by public administrations, businesses and citizens, including of open-source solutions and the re-use of interoperability solutions and frameworks; (e) offer the public sector and the Union industry, in particular SMEs, easy access to testing and piloting of digital technologies and increase the use thereof, including their cross-border use; (f) support the uptake by the public sector and the Union industry, in particular SMEs and start-ups, of advanced digital and related technologies, including in particular HPC, AI, cybersecurity, other leading edge and future technologies, such as distributed ledger technologies (e.g. blockchain); (g) support the design, testing, implementation, and deployment and maintenance of interoperable digital solutions, including digital government solutions, for public services at Union level which are delivered through a data-driven reusable solutions platform aiming to foster innovation and establish common frameworks in order to unleash the full potential of the public administrations’ services for citizens and businesses; (h) ensure the continuous capacity at Union level to lead digital development, in addition to observing, analysing and adapting to fast-evolving digital trends, and share and mainstream best practices; (i) support cooperation towards achieving a European ecosystem for trusted data sharing and digital infrastructures using, inter alia, services and applications based on distributed ledger technologies (e.g. blockchain), including support for interoperability and standardisation and by fostering the deployment of Union cross-border applications based on security and privacy by design, while complying with consumer and data protection legislation; (j) build up and strengthen the European Digital Innovation Hubs and their network. 2. The actions under Specific Objective 5 shall be implemented primarily through direct management. Article 9 Budget 1. The financial envelope for the implementation of the Programme for the period from 1 January 2021 to 31 December 2027 shall be EUR 7 588 000 000 in current prices. 2. The indicative distribution of the amount referred to in paragraph 1 shall be: (a) EUR 2 226 914 000 for Specific Objective 1 – High Performance Computing; (b) EUR 2 061 956 000 for Specific Objective 2 – Artificial Intelligence; (c) EUR 1 649 566 000 for Specific Objective 3 – Cybersecurity and Trust; (d) EUR 577 347 000 for Specific Objective 4 – Advanced Digital Skills; (e) EUR 1 072 217 000 for Specific Objective 5 – Deployment and Best Use of Digital Capacities and Interoperability. 3. The amount referred to in paragraph 1 may also be used for technical and administrative assistance for the implementation of the Programme, such as preparatory, monitoring, control, audit and evaluation activities, including by using corporate information technology systems. 4. Budgetary commitments for actions extending over more than one financial year may be broken down over several years into annual instalments. 5. Resources allocated to Member States under shared management may, at the request of the Member State concerned, be transferred to the Programme, subject to the conditions set out in the relevant provision of the Common Provisions Regulation for 2021-2027, including for the purpose of complementing grants awarded to an action, up to 100 % of the total eligible cost where possible, without prejudice to the co-financing principle laid down in Article 190 of the Financial Regulation and to the State aid rules. The Commission shall implement those resources directly in accordance with point (a) of the first subparagraph of Article 62(1) of the Financial Regulation or indirectly in accordance with point (c) of that subparagraph. Those resources shall be used for the benefit of the Member State concerned. 6. Where the Commission has not entered into a legal commitment under direct or indirect management for resources transferred in accordance with paragraph 5 of this Article, the corresponding uncommitted resources may be transferred back to one or more respective source programmes, at the request of the Member State concerned, in accordance with the conditions set out in the relevant provision of the Common Provisions Regulation for 2021-2027. 7. In accordance with point (a) of the second subparagraph of Article 193(2) of the Financial Regulation, in duly justified cases specified in the financing decision and for a limited period, actions supported under this Regulation and the underlying costs may be considered to be eligible as of 1 January 2021, even if they were implemented and incurred before the grant application was submitted. Article 10 Third countries associated to the Programme 1. The Programme shall be open to the participation of the following third countries through association or partial association, in accordance with the objectives laid down in Article 3: (a) members of the European Free Trade Association, which are members of the European Economic Area, in accordance with the conditions laid down in the Agreement on the European Economic Area; (b) acceding countries, candidate countries and potential candidates, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (c) European Neighbourhood Policy countries, in accordance with the general principles and general terms and conditions for the participation of those countries in Union programmes established in the respective framework agreements and Association Council decisions or in similar agreements and in accordance with the specific conditions laid down in agreements between the Union and those countries; (d) other third countries, in accordance with the conditions laid down in a specific agreement covering the participation of the third country to any Union programme, provided that the agreement: (i) ensures a fair balance as regards the contributions and benefits of the third country participating in the Union programmes; (ii) lays down the conditions of participation in the programmes, including the calculation of financial contributions to individual programmes and their administrative costs; (iii) does not confer on the third country any decision-making power in respect of the Union programme; (iv) guarantees the rights of the Union to ensure sound financial management and to protect its financial interests; The contributions referred to in point (d)(ii) of the first subparagraph shall constitute assigned revenues in accordance with Article 21(5) of the Financial Regulation. 2. Association or partial association of third countries to the Programme shall be without prejudice to Article 12(5). Article 11 International cooperation 1. The Union may cooperate with third countries as referred to in Article 10, with other third countries and with international organisations or bodies established in those countries, in particular within the framework of the Euro-Mediterranean and Eastern Partnerships and with neighbouring countries, especially those of the Western Balkans and Black Sea regions. Without prejudice to Article 18, related costs incurred shall not be covered by the Programme. 2. Cooperation with third countries and organisations as referred to in paragraph 1 of this Article with respect to Specific Objectives 1, 2 and 3 shall be subject to Article 12. Article 12 Security 1. Actions carried out under the Programme shall comply with applicable security rules, including with Union and national law and in particular in relation to the protection of the classified information against unauthorised disclosure. In the case of actions carried out outside the Union using or generating classified information, in addition to compliance with above requirements such actions shall be subject to a security agreement concluded between the Union and the third country in which the activity is conducted. 2. Where appropriate, proposals and tenders to be submitted by applicants shall include a security self-assessment that identifies any security issues and details how those issues are to be addressed in order to comply with Union and national law. 3. Where appropriate, the Commission or the body entrusted with the implementation of the Programme shall carry out a security review of proposals for funding submitted by applicants that raise security issues. 4. Where appropriate, the actions carried out under the Programme shall comply with Commission Decision (EU, Euratom) 2015/444 (26) and the rules implementing that Decision. 5. The work programme may also provide that legal entities established in associated countries and legal entities that are established in the Union but are controlled from third countries are not eligible to participate in all or some actions under Specific Objective 3 for duly justified security reasons. In such cases, calls for proposals and calls for tenders shall be restricted to legal entities established or deemed to be established in Member States and controlled by Member States or by nationals of Member States. 6. If duly justified for security reasons, the work programme may also provide that legal entities established in associated countries and legal entities that are established in the Union but are controlled from third countries may be eligible to participate in all or some actions under Specific Objectives 1 and 2 only if they comply with the requirements to be fulfilled by those legal entities to guarantee the protection of the essential security interests of the Union and the Member States and to ensure the protection of classified documents information. Those requirements shall be set out in the work programme. 7. Where appropriate, the Commission or the body entrusted with the implementation of the Programme shall carry out security checks. Funding for actions which do not comply with the security requirements referred to in this Article may be suspended, terminated or reduced at any time, in accordance with the Financial Regulation. Article 13 Synergies with other Union programmes 1. The Programme shall enable synergies with other Union programmes, as described in Annex III, in particular through arrangements for complementary funding from Union programmes where the management arrangements allow it. Funding from other programmes may be deployed in sequence, in an alternating way, or through the combination of funds, including the joint funding of actions. The Commission shall ensure that the achievement of the specific objectives is not hampered when leveraging the complementary character of the Programme with other Union programmes. 2. The Commission shall ensure the overall consistency and complementarity of the Programme with the relevant policies and Union programmes in cooperation with the Member States. To that end, the Commission shall facilitate the setting up of appropriate mechanisms for coordination between relevant authorities and between such authorities and the Commission, and shall establish appropriate monitoring tools to systematically ensure synergies between the Programme and any relevant Union funding instruments. The arrangements referred to in paragraph 1 shall contribute to avoiding duplications and to maximising the positive impact of expenditure. Article 14 Implementation and forms of Union funding 1. The Programme shall be implemented under direct management, in accordance with the Financial Regulation, or under indirect management by entrusting certain implementation tasks to the bodies referred to in point (c) of the first subparagraph of Article 62(1) of the Financial Regulation, in accordance with Articles 4 to 8 of this Regulation. Bodies entrusted with the implementation of the Programme may depart from the rules on participation and dissemination laid down in this Regulation only where such departure is provided for in the legal act that establishes those bodies or entrusts budget implementation tasks to them or, for the bodies referred to in point (c)(ii), (iii) or (v) of the first subparagraph of Article 62(1) of the Financial Regulation, where such departure is provided for in the contribution agreement and the specific operating needs of such bodies or the nature of the action so require. 2. The Programme may provide funding in any of the forms laid down in the Financial Regulation, including in particular through procurement as a primary form, or grants and prizes. Where the achievement of the objective of an action requires the procurement of innovative goods and services, grants may be awarded only to beneficiaries that are contracting authorities or contracting entities as defined in Directives 2014/24/EU (27) and 2014/25/EU (28) of the European Parliament and of the Council. Where the supply of innovative goods or services that are not yet available on a large-scale commercial basis is necessary to achieve the objectives of an action, the contracting authority or the contracting entity may authorise the award of multiple contracts within the same procurement procedure. For duly justified reasons of public security, the contracting authority or the contracting entity may require that the place of performance of the contract be situated within the territory of the Union. The Programme may also provide financing in the form of financial instruments within blending operations. 3. Contributions to a mutual insurance mechanism may cover the risk associated with the recovery of funds due by recipients and shall be considered to be a sufficient guarantee under the Financial Regulation. Article 37 of Regulation (EU) 2021/695 shall apply. Article 15 European Partnerships The Programme may be implemented through European Partnerships and within the strategic planning between the Commission and the Member States, as referred to in Article 6 of Regulation (EU) 2021/695. Such implementation may include contributions to existing or new public-private partnerships in the form of joint undertakings established under Article 187 TFEU. For those contributions, the provisions of that Regulation relating to European Partnerships shall apply. Article 16 European Digital Innovation Hubs 1. An initial network of European Digital Innovation Hubs shall be established during the first year of the implementation of the Programme. That initial network shall consist of at least one hub for each Member State, unless there is no candidate in a given Member State that can be designated and selected in accordance with paragraphs 2 and 3. 2. For the purpose of establishing the network referred to in paragraph 1 of this Article, each Member State shall designate candidate entities in accordance with its national procedures, administrative and institutional structures through an open and competitive process, on the basis of the following criteria: (a) the appropriate competences related to the activities of the European Digital Innovation Hubs referred to in paragraph 6 of this Article and competences in one or several areas identified in Article 3(2); (b) the appropriate management capacity, staff and infrastructure necessary to carry out the activities referred to in paragraph 6 of this Article; (c) the operational and legal means to apply the administrative, contractual and financial management rules laid down at Union level; and (d) the appropriate financial viability corresponding to the level of Union funds it will be called upon to manage and demonstrated, where appropriate, through guarantees issued preferably by a public authority. 3. The Commission shall, by means of implementing acts, adopt decisions on the selection of entities forming the initial network. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 31(2). The Commission shall take the utmost account of the opinion of each Member State before selecting a European Digital Innovation Hub in its territory. The entities shall be selected by the Commission from candidate entities designated by Member States on the basis of the criteria referred to in paragraph 2 of this Article and the following additional criteria: (a) the budget available for the financing of the initial network; and (b) the need for the initial network to ensure coverage of the needs of industry and areas of public interest and to ensure comprehensive and balanced geographical coverage to improve convergence between Member States benefiting from the Cohesion Fund for 2021 to 2027 established by a Regulation of the European Parliament and of the Council and the other Member States, for example to bridge the digital divide in geographical terms. 4. If necessary, following an open and competitive process, the Commission shall, by means of implementing acts, adopt decisions on the selection of entities forming additional European Digital Innovation Hubs. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 31(2). The Commission shall take the utmost account of the opinion of the Member State before selecting an additional European Digital Innovation Hub in its territory. The Commission shall select additional European Innovation Hubs in such a way to ensure a broad geographical coverage across Europe. The number of entities of the network shall be sufficient to meet the demand for the hubs’ services in given Member States. To address the specific constraints faced by the Union’s outermost regions, specific entities may be nominated to cover the needs of such regions. 5. European Digital Innovation Hubs shall have substantial overall autonomy to lay down their organisation, composition, and working methods. 6. With respect to the implementation of the Programme, European Digital Innovation Hubs shall perform the following activities to the benefit of the Union industry, in particular SMEs and mid-caps, as well as the public sector: (a) raising awareness and providing or ensuring access to digital transformation expertise, knowhow and services, including testing and experimentation facilities; (b) assisting businesses, especially SMEs and start-ups, organisations and public administrations to become more competitive and to improve their business models through use of new technologies covered by the Programme; (c) facilitating the transfer of expertise and knowhow between regions, in particular by matching SMEs, start-ups and mid-caps established in one region with European Digital Innovation Hubs established in other regions that are best suited to providing relevant services; encouraging exchanges of skills and knowledge, joint initiatives and good practices; (d) providing or ensuring access to thematic services, in particular services related to AI, HPC and cybersecurity and trust to the public administrations, public sector organisations, SMEs or mid-caps; (e) providing financial support to third parties under Specific Objective 4. For the purposes of point (d) of the first subparagraph, European Digital Innovation Hubs may specialise in specific thematic services and shall not be required to provide all thematic services or to provide those services to all categories of entities referred to in this paragraph. 7. Where a European Digital Innovation Hub receives funding under the Programme, that funding shall be in the form of grants. CHAPTER II ELIGIBILITY Article 17 Eligible actions 1. Only actions contributing to the achievement of the objectives laid down in Articles 3 to 8 shall be eligible for funding. 2. The eligibility criteria for actions to be carried out under the Programme shall be set out in the work programmes. Article 18 Eligible legal entities 1. The following legal entities shall be eligible to participate in the Programme: (a) legal entities established in: (i) a Member State or an overseas country or territory linked to a Member State; (ii) a third country associated to the Programme in accordance with Articles 10 and 12; (b) any other legal entity created under Union law and any international organisation of European interest. 2. By way of derogation from paragraph 1, legal entities established in a third country which is not associated to the Programme shall be eligible to participate in specific actions where their participation is necessary to achieve the objectives of the Programme. Such entities shall bear the cost of their participation unless specified otherwise in the work programmes. 3. Natural persons shall not be eligible to participate in the Programme, except for grants awarded under Specific Objective 4. 4. The work programme referred to in Article 24 may provide that participation is limited to beneficiaries established only in Member States, or to beneficiaries established in Member States and specific associated countries or other third countries, where there are security reasons for such limitation or where the actions directly relate to the Union’s strategic autonomy. Any limitation of the participation of legal entities established in associated countries shall comply with the terms and conditions of the relevant agreement. CHAPTER III GRANTS Article 19 Grants Grants under the Programme shall be awarded and managed in accordance with Title VIII of the Financial Regulation and may cover up to 100 % of the eligible costs, without prejudice to the co-financing principle as laid down in Article 190 of the Financial Regulation. Such grants shall be awarded and managed as specified for each specific objective. Article 20 Award criteria 1. The award criteria shall be set out in the work programmes and in the calls for proposals, taking into account at least the following elements: (a) the maturity of the action in the project development; (b) the soundness of the implementation plan proposed; (c) the need to overcome financial obstacles such as a lack of market finance. 2. Where applicable, the award criteria, shall take into account the following elements: (a) the stimulating effect of Union support on public and private investment; (b) the expected economic, social, climate and environmental impact; (c) accessibility and ease of access to respective services; (d) a trans-European dimension; (e) a balanced geographical distribution across the Union, including bridging the geographical digital divide, including the outermost regions; (f) the presence of a long-term sustainability plan; (g) the freedom to re-use and adapt the projects’ results; (h) synergies and complementarities with other Union programmes. Article 21 Evaluation In accordance with Article 150 of the Financial Regulation, applications for grants shall be evaluated by an evaluation committee, which may be fully or partially composed of external independent experts. CHAPTER IV BLENDING OPERATIONS AND OTHER COMBINED FUNDING Article 22 Blending operations Blending operations under the Programme shall be carried out in accordance with Regulation (EU) 2021/523 and Title X of the Financial Regulation. Article 23 Cumulative and alternative funding 1. An action that has received a contribution from another Union programme, including funds under shared management, may also receive a contribution under the Programme, provided that the contributions do not cover the same costs. The rules of the relevant Union programme shall apply to the corresponding contribution to the action. The cumulative funding shall not exceed the total eligible costs of the action.The support from the different Union programmes may be calculated on a pro-rata basis in accordance with the documents setting out the conditions for support. 2. In order to be awarded a Seal of Excellence under the Programme, actions shall comply with all of the following conditions: (a) they have been assessed in a call for proposals under the Programme; (b) they comply with the minimum quality requirements of that call for proposals; (c) they are not financed under that call for proposals due to budgetary constraints. In accordance with the relevant provisions of the Common Provisions Regulation for 2021-2027, the ERDF or ESF+ may support proposals submitted to a call for proposals under the Programme, which were awarded a Seal of Excellence in accordance with the Programme. CHAPTER V PROGRAMMING, MONITORING, EVALUATION AND CONTROL Article 24 Work programmes 1. The Programme shall be implemented by means of work programmes as referred to in Article 110 of the Financial Regulation. 2. Work programmes shall in principle be adopted as multiannual programmes, typically every two years, and cover the general objectives of the Programme as well as one or more specific objectives. If justified by specific implementation needs, they may also be adopted as annual programmes. 3. Work programmes shall be consistent with the specific objectives of the Programme, as set out in Articles 4 to 8, while also taking into account the areas and types of activities set out in Annex I. They shall ensure that the actions thereby supported do not crowd out private financing. 4. In order to reflect technological change and market developments, the Commission is empowered to adopt delegated acts in accordance with Article 30 to amend Annex I with regard to the activities set out therein in a manner consistent with the specific objectives of the Programme, as set out in Articles 4 to 8. 5. Work programmes shall set out, where applicable, the overall amount reserved for blending operations. 6. The Commission shall, by means of implementing acts, adopt the work programmes for Specific Objectives 2, 4 and 5 and for possible other actions under direct management for Specific Objectives 1 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 31(2). Article 25 Monitoring and reporting 1. Measurable indicators to monitor the implementation and to report on the progress of the Programme towards the achievement of the specific objectives laid down in Article 3(2) are set out in Annex II. 2. The Commission shall establish a methodology to provide for indicators for accurately assessing progress made towards the achievement of the general objectives laid down in Article 3(1). 3. In order to ensure the effective assessment of the Programme’s progress towards the achievement of its objectives, the Commission is empowered to adopt delegated acts in accordance with Article 30 to amend Annex II with regard to the measurable indicators, where considered to be necessary, as well as to supplement this Regulation with provisions on the establishment of a monitoring and evaluation framework. 4. The performance reporting system shall ensure that data for monitoring the implementation and the results of the Programme are collected efficiently, effectively, and in a timely manner so that the results are suitable for an in-depth analysis of the progress achieved and the difficulties encountered. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where necessary, on Member States. 5. Official EU statistics, such as regular ICT statistical surveys, shall be used to their maximum as context indicators. The Commission shall consult national statistical institutes and shall involve them, together with Eurostat, in the initial design and subsequent development of statistical indicators used for monitoring the implementation of the Programme and progress made with regard to digital transformation. Article 26 Evaluation of the Programme 1. Evaluations of the Programme shall be carried out so that they feed into the decision-making process in a timely manner. They shall contain a qualitative assessment of the progress made towards the achievement of the general objectives of the Programme laid down in Article 3. 2. In addition to regularly monitoring the Programme, the Commission shall conduct an interim evaluation of the Programme which shall be carried out once there is sufficient information available about its implementation, but no later than four years after the start of the implementation of the Programme. The interim evaluation shall form the basis for adjusting the implementation of the Programme, as appropriate, also taking into account new relevant technological developments. 3. At the end of the implementation of the Programme, but no later than four years after the end of the period specified in Article 1, the Commission shall carry out a final evaluation of the Programme. The final evaluation shall assess long-term impacts of the Programme and its sustainability. 4. The evaluation reporting system shall ensure that recipients of Union funds collect data for programme evaluation in an efficient, effective and timely manner and at the appropriate level of granularity. 5. The Commission shall submit the interim evaluation referred to in paragraph 2 and the final evaluation referred to in paragraph 3 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Article 27 Audits 1. Audits on the use of the Union contribution carried out by persons or entities, including by others than those mandated by the Union institutions, bodies, offices or agencies shall form the basis of the overall assurance pursuant to Article 127 of the Financial Regulation. 2. The control system shall ensure an appropriate balance between trust and control, taking into account administrative costs and other costs related to control at all levels. 3. Audits of expenditure shall be carried out in a consistent manner in accordance with the principles of economy, efficiency and effectiveness. 4. As part of the control system, the audit strategy may be based on the financial audit of a representative sample of expenditure. That representative sample shall be complemented by a selection based on an assessment of the risks related to expenditure. 5. Actions that receive cumulative funding from different Union programmes shall be audited only once, covering all programmes concerned and their respective applicable rules. Article 28 Protection of the financial interests of the Union Where a third country participates in the Programme by means of a decision adopted pursuant to an international agreement or on the basis of any other legal instrument, the third country shall grant the necessary rights and access required for the authorising officer responsible, OLAF and the Court of Auditors to comprehensively exercise their respective competences. In the case of OLAF, such rights shall include the right to carry out investigations, including on-the-spot checks and inspections, as provided for in Regulation (EU, Euratom) No 883/2013. Article 29 Information, communication, publicity, policy support and dissemination 1. The recipients of Union funding shall acknowledge the origin of those funds and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. 2. The Commission shall implement information and communication actions relating to the Programme, to actions taken pursuant to the Programme and to the results obtained. The Commission shall also ensure that integrated information is provided and that it reaches potential applicants to Union funding in the digital sector. Financial resources allocated to the Programme shall also contribute to the corporate communication of the political priorities of the Union, insofar as those priorities are related to the objectives referred to in Article 3. 3. The Programme shall provide support to policy development, outreach, awareness-raising and the dissemination of actions related to the Programme and shall promote cooperation and the exchange of experience in the areas referred to in Articles 4 to 8. CHAPTER VI DELEGATED ACTS, IMPLEMENTING ACTS, TRANSITIONAL AND FINAL PROVISIONS Article 30 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 24(4) and Article 25(3) shall be conferred on the Commission until 31 December 2028. 3. The delegation of power referred to in Article 24(4) and Article 25(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 24(4) and Article 25(3) shall only enter into force if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 31 Committee procedure 1. The Commission shall be assisted by the Digital Europe Programme Coordination Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Article 32 Repeal Decision (EU) 2015/2240 is repealed with effect from 1 January 2021. Article 33 Transitional provisions 1. This Regulation shall not affect the continuation of or modification of actions inititated pursuant to Regulation (EU) No 283/2014 of the European Parliament and of the Council (29) and Decision (EU) 2015/2240, which shall continue to apply to those actions until their closure. 2. The financial envelope for the Programme may also cover the technical and administrative assistance expenses necessary to ensure the transition between the Programme and the measures adopted pursuant to Regulation (EU) No 283/2014 and Decision (EU) 2015/2240. 3. If necessary, appropriations may be entered in the Union budget beyond 2027 to cover the expenses provided for in Article 9(4), to enable the management of actions not completed by 31 December 2027. Article 34 Entry into force and application This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. It shall apply from 1 January 2021. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 29 April 2021. For the European Parliament The President D. M. SASSOLI For the Council The President A. P. ZACARIAS (1) OJ C 62, 15.2.2019, p. 292. (2) OJ C 86, 7.3.2019, p. 272. (3) Position of the European Parliament of 17 April 2019 (not yet published in the Official Journal) and position of the Council at first reading of 16 March 2021 (OJ C 124, 9.4.2021, p. 1). Position of the European Parliament of 29 April 2021 (not yet published in the Official Journal). (4) OJ L 433I, 22.12.2020, p. 28. (5) Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433I, 22.12.2020, p. 11). (6) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1). (7) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1). (8) Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). (9) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities’ financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2). (10) Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’) (OJ L 283, 31.10.2017, p. 1). (11) Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). (12) Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union (‘Overseas Association Decision’) (OJ L 344, 19.12.2013, p. 1). (13) OJ L 123, 12.5.2016, p. 1. (14) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (15) Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (OJ L 321, 17.12.2018, p. 36). (16) Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1). (17) Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30). (18) Council Regulation (EU) 2018/1488 of 28 September 2018 establishing the European High Performance Computing Joint Undertaking (OJ L 252, 8.10.2018, p. 1). (19) Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15). (20) OJ L 1, 3.1.1994, p. 3. (21) OJ L 282, 19.10.2016, p. 4. (22) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (23) Decision (EU) 2015/2240 of the European Parliament and of the Council of 25 November 2015 establishing a programme on interoperability solutions and common frameworks for European public administrations, businesses and citizens (ISA2 programme) as a means for modernising the public sector (OJ L 318, 4.12.2015, p. 1). (24) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (25) Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1). (26) Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). (27) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). (28) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243). (29) Regulation (EU) No 283/2014 of the European Parliament and of the Council of 11 March 2014 on guidelines for trans-European networks in the area of telecommunications infrastructure and repealing Decision No 1336/97/EC (OJ L 86, 21.3.2014, p. 14). ANNEX I ACTIONS Technical description of the Programme: scope of actions The initial and, where appropriate, subsequent actions of the Programme shall be implemented in accordance with the following technical description: Specific Objective 1 – High Performance Computing The Programme shall implement the European strategy on HPC by supporting a full Union ecosystem that provides the necessary HPC and data capabilities for Europe to compete globally. The strategy aims to deploy a world-class HPC and data infrastructure with exascale capabilities between 2022 and 2023, and with post-exascale facilities between 2026 and 2027 to endow the Union with its own independent and competitive HPC technology supply, achieve excellence in HPC applications and widen the availability and use of HPC. Initial and, where appropriate, subsequent actions under this objective shall include: 1. A joint procurement framework enabling a co-designed approach for the acquisition of an integrated network of world-class HPC, including the acquisition of exascale supercomputing and data infrastructure. That network will be easily accessible to public and private users, in particular SMEs, irrespective of the Member State in which they are located, and will be easily accessible for research purposes, in accordance with Regulation (EU) 2018/1488. 2. A joint procurement framework for the acquisition of post-exascale supercomputing infrastructure, including the integration with quantum computing technologies. 3. Coordination and adequate financial resources at Union level to support the development, procurement and operation of such infrastructure. 4. Networking of Member States HPC and data capacities and support for Member States wishing to upgrade or acquire new HPC capacities. 5. Networking of national High Performance Computing competence centres, at least one per Member State and associated with their national supercomputing centres to provide HPC services to industry, in particular SMEs, the academic community and public administrations. 6. The deployment of ready to use operational technology, in particular supercomputing as a service resulting from research and innovation to build an integrated European HPC ecosystem, covering all segments of the scientific and industrial value chain (hardware, software, applications, services, interconnections and advanced digital skills). Specific Objective 2 – Artificial Intelligence The Programme shall build up and strengthen core AI capacities in Europe, including data resources and repositories of algorithms, and make them accessible to all public administrations and businesses, and shall reinforce and network existing and newly established AI testing and experimentation facilities in Member States. Initial and, where appropriate, subsequent actions under this objective shall include: 1. The creation of common European data spaces that make accessible data across Europe, including information gathered from the re-use of public sector information, and become a data input source for AI solutions. The spaces should be open to the public and private sectors. For increased usage, data within a space are to be made interoperable, in particular through data formats that are open, machine readable, standardised and documented, both in the interactions between the public and private sectors, within sectors and across sectors (semantic interoperability). 2. The development of common European libraries or interfaces to libraries of algorithms that make them easily accessible to all potential European users on the basis of fair, reasonable and non-discriminatory terms. Businesses and the public sector are to be able to identify and acquire whichever solution would work best for their needs. 3. Co-investment with Member States in world class reference facilities for testing and experimentation in real setting focusing on the applications of AI in essential sectors such as health, earth or environment monitoring, transport and mobility, security, manufacturing and finance, as well as in other areas of public interest. Those facilities are to be open to all actors across Europe and connected to the network of European Digital Innovation Hubs. Those facilities are to be equipped with or connected to large computing and data handling facilities, as well as latest AI technologies, including emerging areas such as neuromorphic computing, deep learning and robotics. Specific Objective 3 – Cybersecurity and Trust The Programme shall stimulate the reinforcement, building and acquisition of essential capacities to secure the Union’s digital economy, society and democracy by reinforcing the Union cybersecurity industrial potential and competitiveness, as well as by improving capabilities of both the private and public sectors to protect citizens and businesses from cyber threats, including by supporting the implementation of Directive (EU) 2016/1148. Initial and, where appropriate, subsequent actions under this objective shall include: 1. Co-investment with Member States in advanced cybersecurity equipment, infrastructures and knowhow that are essential to protect critical infrastructures and the Digital Single Market at large. Such co-investment could include investments in quantum facilities and data resources for cybersecurity, situational awareness in cyberspace as well as other tools to be made available to public and private sector across Europe. 2. Scaling up existing technological capacities and networking the competence centres in Member States and making sure that those capacities respond to public sector and industry needs, including through products and services that reinforce cybersecurity and trust within the Digital Single Market. 3. Ensuring wide deployment of effective state-of-the-art cybersecurity and trust solutions across the Member States. Such deployment includes strengthening the security and safety of products, from their design to their commercialisation. 4. Support closing the cybersecurity skills gap by, for example, aligning cybersecurity skills programmes, adapting them to specific sectorial needs and facilitating access to targeted specialised training. Specific Objective 4 – Advanced digital skills The Programme shall support access to advanced digital skills and training opportunities on those skills, in particular in HPC, big data analytics, AI, distributed ledger technologies (e.g. blockchain) and cybersecurity for the current and future workforce by offering, inter alia, students, recent graduates, current workers and citizens of all ages in need of upskilling, wherever they are situated, with the means to acquire and develop those skills. Initial and, where appropriate, subsequent actions under this objective shall include: 1. Access to on-the-job training by taking part in traineeships in competence centres and businesses that deploy advanced digital technologies. 2. Access to courses in advanced digital technologies which are to be offered by higher education institutions, research institutions and industry professional certification bodies in cooperation with the bodies involved in the Programme (topics are expected to include AI, cybersecurity, distributed ledger technologies (e.g. blockchain), HPC and quantum technologies). 3. Participation in short-term, specialised professional training that have been pre-certified, for example in the area of cybersecurity. Interventions shall focus on advanced digital skills related to specific technologies. The European Digital Innovation Hubs provided for in Article 16 shall act as facilitators for training opportunities, liaising with education and training providers. Specific Objective 5 – Deployment and Best Use of Digital Capacities and Interoperability Projects serving the deployment and the best use of digital capacities or interoperability shall constitute projects of common interest. I. Initial and, where appropriate, subsequent actions under this objective related to the digital transformation of areas of public interest shall include: 1. Modernisation of public administrations: 1.1. Support Member States in the implementation of the principles of the Tallinn Declaration on eGovernment in all policy domains, creating, where necessary, the necessary registries and interconnecting them in full compliance with Regulation (EU) 2016/679. 1.2. Support the design, piloting, deployment, maintenance, evolution and promotion of a coherent eco-system of cross-border digital services infrastructure and facilitate seamless end-to-end, secure, interoperable, multi-lingual cross-border or cross-sector solutions and common frameworks within public administrations. Methodologies for assessing the impact and benefits shall also be included. 1.3. Support the assessment, updating and promotion of existing common specifications and standards as well as the development, establishment and promotion of new common specifications, open specifications and standards through the Union’s standardisation platforms and in cooperation with European or international standardisation organisations as appropriate. 1.4. Cooperate towards a European ecosystem for trusted infrastructures, possibly using services and applications based on distributed ledger technologies (e.g. blockchain), including support for interoperability and standardisation and fostering the deployment of Union cross-border applications. 2. Health 2.1. Ensure that citizens have control over their personal data and can access, share, use, and manage their personal health data across borders securely and in a way that guarantees their privacy, irrespective of their location or the location of the data, in accordance with applicable data protection legislation. Complete the eHealth digital service infrastructure and extend it by new digital services in relation to disease prevention, health and care and support the deployment of such services, building on a broad support by Union activities and Member States, in particular in the eHealth network according to Article 14 of Directive 2011/24/EU of the European Parliament and of the Council (1). 2.2. Make available better data for research, disease prevention and personalised health and care. Ensure that European health researchers and clinical practitioners have access to the necessary scale of resources (shared data spaces, including data storage and computing, expertise and analytical capacities) to achieve breakthroughs in major as well as in rare diseases. The target is to ensure a population-based cohort of at least 10 million citizens. 2.3. Make digital tools available for citizen empowerment and for person-centred care by supporting the exchange of innovative and best practices in digital health, capacity building and technical assistance, in particular for cybersecurity, AI and HPC. 3. Judiciary Enable seamless and secure cross-border electronic communication within the judiciary and between the judiciary and other competent bodies in the area of civil and criminal justice. Improve access to justice and to legal information and procedures for citizens, businesses, legal practitioners and members of the judiciary by providing semantically interoperable interconnections to databases and registers as well as by facilitating online out-of-court dispute resolution. Promote the development and implementation of innovative technologies for courts and the legal profession based, inter alia, on AI solutions which are likely to streamline and speed-up procedures (for example, ‘legal tech’ applications). 4. Transport, mobility, energy and environment Deploy decentralised solutions and infrastructures required for large-scale digital applications such as connected automated driving, unmanned aerial vehicles, smart mobility concepts, smart cities, smart rural areas or outermost regions, in support of transport, energy and environmental policies and in coordination with the actions for digitalising the transport and energy sectors under Connecting Europe Facility. 5. Education, culture and media Provide creators, creative industry and cultural sectors in Europe with access to the latest digital technologies from AI to advanced computing. Exploit the European cultural heritage, including Europeana, to support education and research and to promote cultural diversity, social cohesion and European society. Support the uptake of digital technologies in education, as well as private and publicly funded cultural institutions. 6. Other actions supporting the Digital Single Market Support actions such as fostering digital and media literacy and raising awareness among minors, parents and teachers regarding risks minors may encounter online and ways to protect them, tackling cyberbullying and the dissemination of child sexual abuse material online by supporting a pan-European network of Safer internet Centres. Promote measures aimed at detecting and combatting intentional disinformation spread, thereby increasing the Union’s overall resilience; support a Union observatory for the digital platform economy as well as studies and outreach activities. The actions referred to in points 1 to 6 may be partly supported by European Digital Innovation Hubs through the same capacities developed to assist industry with their digital transformation (see point (II). II Initial and, where appropriate, subsequent actions under this objective related to the digital transformation of industry shall include: Contribution to the upscaling of the network of European Digital Innovation Hubs to ensure access to digital capacities for any business, in particular SMEs, in any region across the Union. Such contribution includes: 1. Access to common European data spaces and AI platforms and European HPC facilities for data analytics and compute intensive applications 2. Access to AI large scale testing facilities and to advanced cybersecurity tools 3. Access to advanced digital skills The actions referred to in the first subparagraph will be coordinated with, and will complement, the innovation actions in digital technologies supported, in particular, under Horizon Europe, as well as investments in European Digital Innovation Hubs supported under the ERDF. Grants for market replication may also be provided from the Programme, in compliance with state aid rules. Support for access to financing for further steps in their digital transformation will be achieved with financial instruments making use of the InvestEU Programme. (1) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). ANNEX II MEASURABLE INDICATORS TO MONITOR THE IMPLEMENTATION AND TO REPORT ON THE PROGRESS OF THE PROGRAMME TOWARDS THE ACHIEVEMENT OF ITS SPECIFIC OBJECTIVES Specific Objective 1 – High Performance Computing 1.1. The number of jointly procured HPC infrastructures 1.2. The usage of the exascale and post-exascale computers in total and by various stakeholder groups (universities, SMEs etc.) Specific Objective 2 – Artificial Intelligence 2.1. The total amount co-invested in testing and experimentation facilities 2.2. The usage of common European libraries or interfaces to libraries of algorithms, usage of common European data spaces and usage of testing and experimentation facilities related to actions under this Regulation 2.3. The number of cases for which organisations decide to integrate AI in their products, processes or services, as a result of the Programme Specific Objective 3 – Cybersecurity and Trust 3.1. The number of cybersecurity infrastructure, or tools, or both jointly procured (1) 3.2. The number of users and user communities getting access to European cybersecurity facilities Specific Objective 4 – Advanced Digital Skills 4.1. The number of persons who have received training to acquire advanced digital skills supported by the Programme 4.2. The number of enterprises, in particular SMEs, having difficulty recruiting ICT specialists 4.3. The number of people reporting an improved employment situation after the end of the training supported by the Programme Specific Objective 5 – Deployment and Best Use of Digital Capacity and Interoperability 5.1. The take-up of digital public services 5.2. Enterprises with high digital intensity score 5.3. The extent of the alignment of the National Interoperability Framework with the European Interoperability Framework 5.4. The number of businesses and public sector entities which have used the services of European Digital Innovation Hubs (1) ‘Infrastructures’ would typically mean a research or experimentation infrastructure such as testbeds, cyber ranges or computing/communication facilities. This could be either data and/or software only, or involve physical facilities. ’Tools’ would typically mean a physical device and/or software/algorithm used to increase the security of ICT systems. Examples would be intrusion detection software or data resources allowing situational awareness of critical infrastructures. The Cybersecurity Competence Centre Regulation allows all sorts of procurement, not only joint procurement: by the European Cybersecurity Industrial, Technology and Research Competence Centre as a Union body; by others with the help of a Union grant; or by several parties. ANNEX III SYNERGIES WITH OTHER UNION PROGRAMMES 1. Synergies with Horizon Europe shall ensure that: (a) although several thematic areas addressed by the Programme and Horizon Europe converge, the type of actions to be supported, their expected outputs and their intervention logic are different and complementary; (b) Horizon Europe will provide extensive support for research, technological development, demonstration, piloting, proof-of-concept, testing and innovation including pre-commercial deployment of innovative digital technologies, in particular through: (i) a dedicated budget in the pillar ‘Global Challenges and European Industrial Competitiveness’ for the cluster ‘Digital, Industry and Space’ to develop enabling technologies (AI and robotics, Next Generation internet, HPC and Big Data, key digital technologies, combining digital with other technologies); (ii) support to research infrastructures under the pillar ‘Excellent Science’; (iii) the integration of digital across all the Global Challenges (health, security, energy and mobility, climate, etc.); and (iv) support for scale-up breakthrough innovations under the pillar ‘Innovative Europe’ (many of which will combine digital and physical technologies); (c) the Programme will invest in: (i) digital capacity building in HPC, AI, distributed ledger technologies (e.g. blockchain), cybersecurity and advanced digital skills; and (ii) national, regional and local deployment within an Union framework of digital capacities and the latest digital technologies in areas of public interest (such as health, public administration, justice and education) or market failure (such as the digitisation of businesses, in particular SMEs); (d) the capacities and infrastructures of the Programme are made available to the research and innovation community, including for actions supported through Horizon Europe, such as testing, experimentation and demonstrations across all sectors and disciplines; (e) as the development of novel digital technologies matures through Horizon Europe, those technologies will progressively be taken up and deployed by the Programme; (f) Horizon Europe initiatives for the development of skills and competencies curricula, including those delivered at the co-location centres of the EIT’s KICs, are complemented by capacity-building in advanced digital skills supported by the Programme; (g) strong coordination mechanisms for programming and implementation are put in place, aligning all procedures for both programmes to the extent possible. Their governance structures will involve all Commission concerned services. 2. Synergies with Union programmes under shared management, including the ERDF, ESF+, the European Agricultural Fund for Rural Development and the European Maritime, Fisheries and Acquaculture Fund, shall ensure that: (a) arrangements for complementary funding from Union programmes under shared management and the Programme are used to support actions providing a bridge between smart specialisations and support to the digital transformation of the European economy and society; (b) the ERDF contributes to the development and strengthening of regional and local innovation ecosystems, industrial transformation, as well as the digital transformation of society and of public administrations, thereby also stimulating the implementation of the Tallinn Declaration on eGovernment. This includes support for the digital transformation of industry and the take-up of results, as well as the rolling out of novel technologies and innovative solutions. The Programme will complement and support the trans-national networking and mapping of digital capacities to make them accessible to SMEs and to make interoperable IT solutions accessible in all Union regions. 3. Synergies with the Connecting Europe Facility shall ensure that: (a) the Programme focuses on large-scale digital capacity and infrastructure building in the areas of HPC, AI, cybersecurity and advanced digital skills, aiming at the wide uptake and deployment across Europe of critical existing or tested innovative digital solutions within a Union framework in areas of public interest or market failure. The Programme is mainly to be implemented through coordinated and strategic investments with Member States, in particular through joint public procurement, in digital capacities to be shared across Europe and in Union-wide actions that support interoperability and standardisation as part of developing the Digital Single Market; (b) the capacities and infrastructures of the Programme are to be made available to the deployment of innovative new technologies and solutions in the field of mobility and transport. The Connecting Europe Facility is to support the roll-out and deployment of innovative new technologies and solutions in the field of mobility and transport; (c) coordination mechanisms are to be established, in particular through appropriate governance structures. 4. Synergies with InvestEU Programme shall ensure that: (a) support through market-based financing, including pursuing policy objectives under the Programme is provided under Regulation (EU) 2021/523; such market-based financing might be combined with the grant support; (b) access to financial instruments by businesses is facilitated by the support provided by European Digital Innovation Hubs. 5. Synergies with Erasmus+ shall ensure that: (a) the Programme supports the development and acquisition of the advanced digital skills needed for the deployment of cutting-edge technologies such as AI or HPC, in cooperation with relevant industries; (b) the advanced skills part of Erasmus+ complements the interventions of the Programme, addressing the acquisition of skills in all domains and at all levels through mobility experiences. 6. Synergies with Creative Europe established by a Regulation of the European Parliament and of the Council shall ensure that: (a) the MEDIA strand of Creative Europe supports initiatives that can generate real impact for cultural and creative sectors across Europe, helping them adapt to the digital transformation; (b) the Programme, inter alia, provides creators, creative industry and cultural sector in Europe with access to latest digital technologies from AI to advanced computing. 7. Synergies with other Union programmes and initiatives on competencies and skills shall be ensured.

Digital Europe programme (2021–2027) Digital Europe programme (2021–2027) SUMMARY OF: Regulation (EU) 2021/694 establishing the Digital Europe Programme WHAT IS THE AIM OF THE REGULATION? The digital Europe programme is a European Union (EU) funding programme designed to bring digital technology to businesses, citizens and public administrations. It aims to: improve the EU’s competitiveness in the global digital economy; contribute to bridging the digital divide across the EU and reinforcing its strategic autonomy; strengthen and promote Europe’s capacities in key digital technology areas through large-scale deployment. KEY POINTS The programme runs from 1 January 2021 to 31 December 2027, i.e. the period of the multiannual financial framework. It is backed by an indicative allocation of more than €7.5 billion at 2021 prices and is implemented mainly under direct management by the European Commission. The regulation sets out 5 specific objectives aiming to widen Europe’s capacities in key digital technology areas in the private sector and in areas of public interest. High-performance computing (€2,226,914,000) The operational objectives are primarily implemented through the European high-performance computing joint undertaking, set up under Regulation (EU) 2018/1488: easily accessible world-class exascale* supercomputing and data infrastructure for public and private users — particularly small and medium-sized enterprises (SMEs), easily accessible for research, in accordance with Regulation (EU) 2018/1488; an EU-wide high-performance computing ecosystem, covering science and industry, including hardware, software, applications, services, interconnections and digital skills; post-exascale infrastructure, including integration with quantum computing technologies and research infrastructures for computing science and encouraging the necessary hardware and software development. Artificial intelligence (AI) (€2,061,956,000) Supports the following operational objectives: core AI capacities and knowledge, including better quality data resources and exchange mechanisms, and libraries of algorithms, accessible to businesses — especially SMEs and start-ups — as well as citizens, not-for-profit organisations, research institutions, universities and public administrations; EU testing and experimentation facilities for commercial application and production systems to better integrate technologies within value chains. Cybersecurity and trust (€1,649,566,000) Supports the following operational objectives: advanced cybersecurity equipment, tools and data infrastructures, together with the EU Member States; knowledge, capacity and skills related to cybersecurity, including best practices; capabilities of the Member States and the private sector in support of the Cybersecurity of NIS directive (Directive (EU) 2016/1148); resilience, risk-awareness and at least basic levels of cybersecurity; better coordination between the civilian and defence cybersecurity spheres. Advanced digital skills (€577,347,000) The programme supports the development of advanced digital skills to: increase Europe’s talent pool; bridge the digital divide and foster greater professionalism, especially in high-performance and cloud computing, big data analytics, cybersecurity, distributed ledger technologies (e.g. blockchain), quantum technologies, robotics and AI. Operational objectives include high-quality short-term and long-term training and courses, on-the-job training, and work placements (as appropriate) for students and the workforce, in particular in SMEs and in the public sector. Deployment and best use of digital capacity and interoperability (€1,072,217,000) Supports the following objectives: effective deployment of state-of-the-art digital technologies, such as HPC, AI and cybersecurity by actors in the public sector and in areas of public interest, such as health and care, education, judiciary, customs, transport, mobility, energy, environment, cultural and creative sectors; deployment and use of integrated and interoperable trans-European infrastructures and agreed digital standards in the public sector; use of solutions and frameworks including of open-source solutions by public administrations, businesses and citizens; easy access to digital technology testing and piloting of digital technologies for the public sector and EU industry, particularly SMEs; support uptake of advanced digital technologies, including HPC, AI, cybersecurity and blockchain, by the public sector and industry, particularly SMEs and start-ups; ensure continuous capacity at EU level to lead digital development, observing, analysing and adapting to fast-evolving digital trends, and sharing best practices; build a future European ecosystem for trusted data sharing and digital infrastructures. A network of European digital innovation hubs will provide access to technological expertise for businesses — in particular SMEs — and public administrations. These hubs will bring together industry, businesses and administrations in need of new technological solutions, and companies with market-ready solutions. The programme involves co-financing from Member States and, when needed, from the private sector. Grants under the programme may cover up to 100% of the eligible costs. The programme is also open to the participation of the following non-EU countries through association or partial association: European Free Trade Association (EFTA) members who are members of the European Economic Area (EEA); candidate countries and potential candidates; European Neighbourhood Policy countries; other non-EU countries by agreement. Digital Europe is complementary to other programmes supporting digital transition, such as Horizon Europe, which focuses on research and technological development, and the digital aspects of the Connecting Europe Facility. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2021. BACKGROUND See also: The Digital Europe Programme (European Commission) High Performance Computing (European Commission) A European approach to artificial intelligence (European Commission) Cybersecurity in the Digital Europe programme (European Commission) Digital skills initiatives (European Commission). KEY TERMS Exascale: next-generation computing systems capable of executing 1018 (10 to the power of 18) floating operations per second. MAIN DOCUMENT Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 (OJ L 166, 11.5.2021, pp. 1–34). RELATED DOCUMENTS Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe — the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, pp. 1–68). Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433I, 22.12.2020, pp. 11–22). Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, pp. 15–69). Council Regulation (EU) 2021/1173 of 13 July 2021 on establishing the European High Performance Computing Joint Undertaking and repealing Regulation (EU) 2018/1488 (OJ L 256, 19.7.2021, pp. 3–51). Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, pp. 1–30). last update 24.09.2021

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